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Sample records for clinical outcome measures

  1. Responsiveness of Clinical Outcome Measures

    DEFF Research Database (Denmark)

    Lauridsen, Henrik Hein

    to condition alterations in PrS patients and should be added as an outcome measure to standard questionnaires used serially. The prospective acceptable outcome method offers a benchmark by which clinicians can balance any mismatch between what are acceptable outcomes to the patient with what is realistically......, the most commonly used retrospective method to establish the MCID has inherent methodological flaws. Perhaps it would be more prudent to ask LBP patients what is an acceptable result of the treatment before it begins? Objectives The overall objective was to establish the responsiveness and MCID in specific...... subgroups of patients with LBP. In addition, we explored whether low back pain patients were able to determine an acceptable treatment outcome before it began. Methods The responsiveness in subgroups study. An extensive cross-cultural adaptation and validation of the ODI was carried out on patients seen...

  2. Clinical Outcome Measures in Chiari I Malformation.

    Science.gov (United States)

    Yarbrough, Chester K; Greenberg, Jacob K; Park, Tae Sung

    2015-10-01

    Chiari malformation type 1 (CM-I) is a common and often debilitating neurologic disease. Reliable evaluation of treatments has been hampered by inconsistent use of clinical outcome measures. A variety of outcome measurement tools are available, although few have been validated in CM-I. The recent development of the Chicago Chiari Outcome Scale and the Chiari Symptom Profile provides CM-I-specific instruments to measure outcomes in adults and children, although validation and refinement may be necessary.

  3. Clinical outcome measures in juvenile idiopathic arthritis.

    Science.gov (United States)

    Consolaro, Alessandro; Giancane, Gabriella; Schiappapietra, Benedetta; Davì, Sergio; Calandra, Serena; Lanni, Stefano; Ravelli, Angelo

    2016-04-18

    Juvenile idiopathic arthritis (JIA), as a chronic condition, is associated with significant disease- and treatment-related morbidity, thus impacting children's quality of life. In order to optimize JIA management, the paediatric rheumatologist has begun to regularly use measurements of disease activity developed, validated and endorsed by international paediatric rheumatology professional societies in an effort to monitor the disease course over time and assess the efficacy of therapeutic interventions in JIA patients.A literature review was performed to describe the main outcome measures currently used in JIA patients to determine disease activity status.The Juvenile Disease Activity Score (JADAS), in its different versions (classic JADAS, JADAS-CRP and cJADAS) and the validated definitions of disease activity and response to treatment represent an important tool for the assessment of clinically relevant changes in disease activity, leading more and more to a treat-to-target strategy, based on a tight and thorough control of the patient condition. Moreover, in recent years, increasing attention on the incorporation of patient-reported or parent-reported outcomes (PRCOs), when measuring the health state of patients with paediatric rheumatic diseases has emerged.We think that the care of JIA patients cannot be possible without taking into account clinical outcome measures and, in this regard, further work is required.

  4. Korean Clinic Based Outcome Measure Studies

    Directory of Open Access Journals (Sweden)

    Jongbae Park

    2003-02-01

    Full Text Available Background: Evidence based medicine has become main tools for medical practice. However, conducting a highly ranked in the evidence hierarchy pyramid is not easy or feasible at all times and places. There remains a room for descriptive clinical outcome measure studies with admitting the limit of the intepretation. Aims: Presents three Korean clinic based outcome measure studies with a view to encouraging Korean clinicians to conduct similar studies. Methods: Three studies are presented briefly here including 1 Quality of Life of liver cancer patients after 8 Constitutional acupuncture; 2 Developing a Korean version of Measuring yourself Medical Outcome profile (MYMOP; and 3 Survey on 5 Shu points: a pilot In the first study, we have included 4 primary or secondary liver cancer patients collecting their diagnostic X-ray film and clinical data f개m their hospital, and asked them to fill in the European Organization Research and Treatment of Cancer, Quality of Life Questionnaire before the commencement of the treatment. The acupuncture treatment is set up format but not disclosed yet. The translation and developing a Korean version of outcome measures that is Korean clinician friendly has been sought for MYMOP is one of the most appropriate one. The permission was granted, the translation into Korean was done, then back translated into English only based on the Korean translation by the researcher who is bilingual in both languages. The back translation was compared by the original developer of MYMOP and confirmed usable. In order to test the existence of acupoints and meridians through popular forms of Korean acupuncture regimes, we aim at collecting opinions from 101 Korean clinicians that have used those forms. The questions asked include most effective symptoms, 5 Shu points, points those are least likely to use due to either adverse events or the lack of effectiveness, theoretical reasons for the above proposals, proposing outcome measures

  5. Observer bias in randomized clinical trials with measurement scale outcomes

    DEFF Research Database (Denmark)

    Hróbjartsson, Asbjørn; Thomsen, Ann Sofia Skou; Emanuelsson, Frida;

    2013-01-01

    BACKGROUND:Clinical trials are commonly done without blinded outcome assessors despite the risk of bias. We wanted to evaluate the effect of nonblinded outcome assessment on estimated effects in randomized clinical trials with outcomes that involved subjective measurement scales. METHODS......:We conducted a systematic review of randomized clinical trials with both blinded and nonblinded assessment of the same measurement scale outcome. We searched PubMed, EMBASE, PsycINFO, CINAHL, Cochrane Central Register of Controlled Trials, HighWire Press and Google Scholar for relevant studies. Two......%). Heterogeneity was moderate (I(2) = 46%, p = 0.02) and unexplained by metaregression. INTERPRETATION:We provide empirical evidence for observer bias in randomized clinical trials with subjective measurement scale outcomes. A failure to blind assessors of outcomes in such trials results in a high risk...

  6. Outcome Measures for Clinical Drug Trials in Autism

    OpenAIRE

    Aman, Michael G; Novotny, Sherie; Samango-Sprouse, Carole; Lecavalier, Luc; Leonard, Elizabeth; Gadow, Kenneth D.; King, Bryan H; Pearson, Deborah A.; Gernsbacher, Morton Ann; Chez, Michael

    2004-01-01

    This paper identifies instruments and measures that may be appropriate for randomized clinical trials in participants with autism spectrum disorders (ASDs). The Clinical Global Impressions scale was recommended for all randomized clinical trials. At this point, however, there is no “perfect” choice of outcome measure for core features of autism, although we will discuss five measures of potential utility. Several communication instruments are recommended, based in part on suitability across t...

  7. Outcome Measures in Clinical Trials for Multiple Sclerosis.

    Science.gov (United States)

    van Munster, Caspar E P; Uitdehaag, Bernard M J

    2017-02-09

    Due to the heterogeneous nature of the disease, it is a challenge to capture disease activity of multiple sclerosis (MS) in a reliable and valid way. Therefore, it can be difficult to assess the true efficacy of interventions in clinical trials. In phase III trials in MS, the traditionally used primary clinical outcome measures are the Expanded Disability Status Scale and the relapse rate. Secondary outcome measures in these trials are the number or volume of T2 hyperintense lesions and gadolinium-enhancing T1 lesions on magnetic resonance imaging (MRI) of the brain. These secondary outcome measures are often primary outcome measures in phase II trials in MS. Despite several limitations, the traditional clinical measures are still the mainstay for assessing treatment efficacy. Newer and potentially valuable outcome measures increasingly used or explored in MS trials are, clinically, the MS Functional Composite and patient-reported outcome measures, and on MRI, brain atrophy and the formation of persisting black holes. Several limitations of these measures have been addressed and further improvements will probably be proposed. Major improvements are the coverage of additional functional domains such as cognitive functioning and assessment of the ability to carry out activities of daily living. The development of multidimensional measures is promising because these measures have the potential to cover the full extent of MS activity and progression. In this review, we provide an overview of the historical background and recent developments of outcome measures in MS trials. We discuss the advantages and limitations of various measures, including newer assessments such as optical coherence tomography, biomarkers in body fluids and the concept of 'no evidence of disease activity'.

  8. Outcome measures in amyotrophic lateral sclerosis clinical trials

    Science.gov (United States)

    Paganoni, Sabrina; Cudkowicz, Merit; Berry, James D

    2017-01-01

    Amyotrophic lateral sclerosis (ALS) is a neurodegenerative disease with an average survival of 3–5 years. While therapies for ALS remain limited, basic and translational ALS research has been host to numerous influential discoveries in recent years. These discoveries have led to a large pipeline of potential therapies that await testing in clinical trials. Until recently, ALS clinical trials have relied on a limited cadre of ‘traditional’ outcome measures, including survival and measures of function. These measures have proven useful, although imperfect, in Phase III ALS trials. However, their utility in early-phase ALS trials is limited. For these early trials, outcome measures focused on target engagement or biological pathway analysis might improve trial outcomes and better support the drug development process.

  9. A clinically meaningful theory of outcome measures in rehabilitation medicine.

    Science.gov (United States)

    Massof, Robert W

    2010-01-01

    Comparative effectiveness research in rehabilitation medicine requires the development and validation of clinically meaningful and scientifically rigorous measurements of patient states and theories that explain and predict outcomes of intervention. Patient traits are latent (unobservable) variables that can be measured only by inference from observations of surrogate manifest (observable) variables. In the behavioral sciences, latent variables are analogous to intensive physical variables such as temperature and manifest variables are analogous to extensive physical variables such as distance. Although only one variable at a time can be measured, the variable can have a multidimensional structure that must be understood in order to explain disagreements among different measures of the same variable. The use of Rasch theory to measure latent trait variables can be illustrated with a balance scale metaphor that has randomly added variability in the weights of the objects being measured. Knowledge of the distribution of the randomly added variability provides the theoretical structure for estimating measures from ordinal observation scores (e.g., performance measures or rating scales) using statistical inference. In rehabilitation medicine, the latent variable of primary interest is the patient's functional ability. Functional ability can be estimated from observations of surrogate performance measures (e.g., speed and accuracy) or self-report of the difficulty the patient experiences performing specific activities. A theoretical framework borrowed from project management, called the Activity Breakdown Structure (ABS), guides the choice of activities for assessment, based on the patient's value judgments, to make the observations clinically meaningful. In the case of low vision, the functional ability measure estimated from Rasch analysis of activity difficulty ratings was discovered to be a two-dimensional variable. The two visual function dimensions are independent

  10. Outcome Measures for Clinical Drug Trials in Autism

    Science.gov (United States)

    Aman, Michael G.; Novotny, Sherie; Samango-Sprouse, Carole; Lecavalier, Luc; Leonard, Elizabeth; Gadow, Kenneth D.; King, Bryan H.; Pearson, Deborah A.; Gernsbacher, Morton Ann; Chez, Michael

    2015-01-01

    This paper identifies instruments and measures that may be appropriate for randomized clinical trials in participants with autism spectrum disorders (ASDs). The Clinical Global Impressions scale was recommended for all randomized clinical trials. At this point, however, there is no “perfect” choice of outcome measure for core features of autism, although we will discuss five measures of potential utility. Several communication instruments are recommended, based in part on suitability across the age range. In trials where the intention is to alter core features of ASDs, adaptive behavior scales are also worthy of consideration. Several “behavior complexes” common to ASDs are identified, and instruments are recommended for assessment of these. Given the prevalence of cognitive impairment in ASDs, it is important to assess any cognitive effects, although cognitive data from ASD randomized clinical trials, thus far, are minimal. Guidance from trials in related pharmacologic areas and behavioral pharmacology may be helpful. We recommend routine elicitation of side effects, height and weight, vital signs, and (in the case of antipsychotics) extrapyramidal side-effects assessment. It is often appropriate to include laboratory tests and assessments for continence and sleep pattern. PMID:14999174

  11. Measuring, comparing and improving clinical outcomes in gastrointestinal cancer surgery

    NARCIS (Netherlands)

    Henneman, D.

    2016-01-01

    In this thesis, hospital variation concerning various surgical outcomes is illustrated, thereby exploring the usability of these outcomes for hospital comparisons, both from a clinical and methodological point of view. Moreover, the studies provide insight in risk factors for adverse events in color

  12. Measuring, comparing and improving clinical outcomes in gastrointestinal cancer surgery

    OpenAIRE

    Henneman, D.

    2016-01-01

    In this thesis, hospital variation concerning various surgical outcomes is illustrated, thereby exploring the usability of these outcomes for hospital comparisons, both from a clinical and methodological point of view. Moreover, the studies provide insight in risk factors for adverse events in colorectal and oesophageal cancer surgery, focusing on the mechanism behind postoperative complications leading to mortality or not.

  13. Measuring cognitive outcomes in a pre-clinical bioethics course.

    Science.gov (United States)

    Fernandes, Ashley K; Borges, Nicole; Rodabaugh, Heather

    2012-05-01

    Medical schools universally accept the idea that bioethics courses are essential components of education, but few studies which measure outcomes (i.e., knowledge or retention) have demonstrated their educational value in the literature. The goal of this study was to examine whether core concepts of a pre-clinical bioethics course were learned and retained. Over the course of 2 years, a pre-test comprising 25 multiple-choice questions was administered to two classes (2008-2010) of first-year medical students prior to the start of a 15-week ethics course, and an identical post-test was administered at the end of the course. A total of 189 students participated. Paired t tests showed a significant difference between pre-test scores and post-test scores. The pre-test average score was 69.8 %, and the post-test average was 82.6 %, an increase of 12.9 % after the ethics course. The pre- and post-test results also suggested a shift in difficulty level of the questions, with students finding identical questions easier after the intervention. Given the increase in post-test scores after the 15-week intervention, the study suggests that core concepts in medical ethics were learned and retained. These results demonstrate that an introductory bioethics course can improve short-term outcomes in knowledge and comprehension, and should provide impetus to educators to demonstrate improved educational outcomes in ethics at higher levels of B.S. Bloom's Taxonomy of Learning.

  14. Disability outcome measures in multiple sclerosis clinical trials

    DEFF Research Database (Denmark)

    Cohen, Jeffrey A; Reingold, Stephen C; Polman, Chris H;

    2012-01-01

    recommend practical refinements. Conversely, although substantial data support the multiple sclerosis functional composite as an alternative measure, changes to its component tests and scoring method are needed. Novel approaches, including the use of composite endpoints, patient-reported outcomes......, and measurement of biomarkers, show promise as adjuncts to the current disability measures, but are insufficiently validated to serve as substitutes. A collaborative approach that involves academic experts, regulators, industry representitives, and funding agencies is needed to most effectively develop disability...

  15. Training clinicians in how to use patient-reported outcome measures in routine clinical practice

    OpenAIRE

    Santana, MJ; Haverman, L; Absolom, K; Takeuchi, E.; Feeny, D; Grootenhuis, M; Velikova, G

    2015-01-01

    Introduction: Patient-reported outcome measures (PROs) were originally developed for comparing groups of people in clinical trials and population studies, and the results were used to support treatment recommendations or inform health policy, but there was not direct benefit for the participants providing PROs data. However, as the experience in using those measures increased, it became obvious the clinical value in using individual patient PROs profiles in daily practice to identify/monitor ...

  16. Psychometric properties of the Spanish version of the Clinical Outcomes in Routine Evaluation – Outcome Measure

    Directory of Open Access Journals (Sweden)

    Trujillo A

    2016-06-01

    Full Text Available Adriana Trujillo,1,2 Guillem Feixas,1,2 Arturo Bados,1 Eugeni García-Grau,1 Marta Salla,1 Joan Carles Medina,1 Adrián Montesano,1,2 José Soriano,3 Leticia Medeiros-Ferreira,4 Josep Cañete,5 Sergi Corbella,6 Antoni Grau,7 Fernando Lana,8 Chris Evans9 1Department of Personality, Assessment and Psychological Treatments, Faculty of Psychology, 2Institute for Brain, Cognition and Behaviour, University of Barcelona, 3Hospital of the Holy Cross and Saint Paul, 4Nou Barris Mental Health Center, Barcelona, 5Hospital of Mataró, Sanitary Consortium of Maresme, Mataró, 6FPCEE, Blanquerna, Universitat Ramon Llull, 7Institute of Eating Disorders, Barcelona, 8MAR Health Park, CAEMIL, Santa Coloma de Gramenet, Spain; 9East London NHS Foundation Trust, NPDDNet, London, UK Objective: The objective of this paper is to assess the reliability and validity of the Spanish translation of the Clinical Outcomes in Routine Evaluation – Outcome Measure, a 34-item self-report questionnaire that measures the client’s status in the domains of Subjective well-being, Problems/Symptoms, Life functioning, and Risk.Method: Six hundred and forty-four adult participants were included in two samples: the clinical sample (n=192 from different mental health and primary care centers; and the nonclinical sample (n=452, which included a student and a community sample.Results: The questionnaire showed good acceptability and internal consistency, appropriate test–retest reliability, and acceptable convergent validity. Strong differentiation between clinical and nonclinical samples was found. As expected, the Risk domain had different characteristics than other domains, but all findings were comparable with the UK referential data. Cutoff scores were calculated for clinical significant change assessment.Conclusion: The Spanish version of the Clinical Outcomes in Routine Evaluation – Outcome Measure showed acceptable psychometric properties, providing support for using the

  17. Efficacy Outcome Measures for Procedural Sedation Clinical Trials in Adults: An ACTTION Systematic Review.

    Science.gov (United States)

    Williams, Mark R; McKeown, Andrew; Dexter, Franklin; Miner, James R; Sessler, Daniel I; Vargo, John; Turk, Dennis C; Dworkin, Robert H

    2016-01-01

    Successful procedural sedation represents a spectrum of patient- and clinician-related goals. The absence of a gold-standard measure of the efficacy of procedural sedation has led to a variety of outcomes being used in clinical trials, with the consequent lack of consistency among measures, making comparisons among trials and meta-analyses challenging. We evaluated which existing measures have undergone psychometric analysis in a procedural sedation setting and whether the validity of any of these measures support their use across the range of procedures for which sedation is indicated. Numerous measures were found to have been used in clinical research on procedural sedation across a wide range of procedures. However, reliability and validity have been evaluated for only a limited number of sedation scales, observer-rated pain/discomfort scales, and satisfaction measures in only a few categories of procedures. Typically, studies only examined 1 or 2 aspects of scale validity. The results are likely unique to the specific clinical settings they were tested in. Certain scales, for example, those requiring motor stimulation, are unsuitable to evaluate sedation for procedures where movement is prohibited (e.g., magnetic resonance imaging scans). Further work is required to evaluate existing measures for procedures for which they were not developed. Depending on the outcomes of these efforts, it might ultimately be necessary to consider measures of sedation efficacy to be procedure specific.

  18. The challenges of translating the clinical outcomes in Routine Evaluation-Outcome Measure (CORE-OM) into British Sign Language.

    Science.gov (United States)

    Rogers, Katherine D; Young, Alys; Lovell, Karina; Evans, Chris

    2013-01-01

    This article discusses translation issues arising during the production of a British Sign Language (BSL) version of the psychological outcome measure "Clinical Outcomes in Routine Evaluation-Outcome Measure" (CORE-OM). The process included forward translation, meeting with a team of translators, producing a second draft of the BSL version and back translating into English. Further modifications were made to the BSL version before piloting it with d/Deaf populations. Details of the translation process are addressed, including (a) the implications of translating between modalities (written text to visual language); (b) clarity of frequency anchors: analog versus digital encoding; (c) pronouns and the direction of signing; and (iv) the influence of the on-screen format. The discussion of item-specific issues encountered when producing a BSL version of the CORE-OM includes the expression of precise emotional states in a language that uses visual modifiers, problems associated with iconic signs, and the influence of Deaf world knowledge when interpreting specific statements. Finally, it addresses the extent to which lessons learned through this translation process are generalizable to other signed languages and spoken language translations of standardized instruments. Despite the challenges, a BSL version of the CORE-OM has been produced and found to be reliable.

  19. Cerebral atrophy as outcome measure in short-term phase 2 clinical trials in multiple sclerosis

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    Elskamp, I.J. van den; Boden, B.; Barkhof, F. [VU University Medical Center, Department of Radiology, MS Center Amsterdam, Amsterdam (Netherlands); Dattola, V. [VU University Medical Center, Department of Radiology, MS Center Amsterdam, Amsterdam (Netherlands); University of Messina, Department of Neurosciences, Psychiatric and Anaesthesiological Sciences, Messina (Italy); Knol, D.L. [VU University Medical Center, Department of Epidemiology and Biostatistics, Amsterdam (Netherlands); Filippi, M. [Scientific Institute and University Ospedale San Raffaele, Neuroimaging Research Unit, Milan (Italy); Kappos, L. [University Hospital, University of Basel, Department of Neurology, Basel (Switzerland); Fazekas, F. [Medical University of Graz, Department of Neurology, Graz (Austria); Wagner, K. [Bayer-Schering Pharma, Berlin (Germany); Pohl, C. [Bayer-Schering Pharma, Berlin (Germany); University Hospital Bonn, Department of Neurology, Bonn (Germany); Sandbrink, R. [Bayer-Schering Pharma, Berlin (Germany); Heinrich-Heine-University Dusseldorf, Department of Neurology, Dusseldorf (Germany); Polman, C.H. [VU University Medical Center, Department of Neurology, MS Center Amsterdam, Amsterdam (Netherlands); Uitdehaag, B.M.J. [VU University Medical Center, Department of Epidemiology and Biostatistics, Amsterdam (Netherlands); VU University Medical Center, Department of Neurology, MS Center Amsterdam, Amsterdam (Netherlands)

    2010-10-15

    Cerebral atrophy is a compound measure of the neurodegenerative component of multiple sclerosis (MS) and a conceivable outcome measure for clinical trials monitoring the effect of neuroprotective agents. In this study, we evaluate the rate of cerebral atrophy in a 6-month period, investigate the predictive and explanatory value of other magnetic resonance imaging (MRI) measures in relation to cerebral atrophy, and determine sample sizes for future short-term clinical trials using cerebral atrophy as primary outcome measure. One hundred thirty-five relapsing-remitting multiple sclerosis patients underwent six monthly MRI scans from which the percentage brain volume change (PBVC) and the number and volume of gadolinium (Gd)-enhancing lesions, T2 lesions, and persistent black holes (PBH) were determined. By means of multiple linear regression analysis, the relationship between focal MRI variables and PBVC was assessed. Sample size calculations were performed for all patients and subgroups selected for enhancement or a high T2 lesion load at baseline. A significant atrophy occurred over 6 months (PBVC = -0.33%, SE = 0.061, p < 0.0001). The number of baseline T2 lesions (p = 0.024), the on-study Gd-enhancing lesion volume (p = 0.044), and the number of on-study PBHs (p = 0.003) were associated with an increased rate of atrophy. For a 50% decrease in rate of atrophy, the sample size calculations showed that approximately 283 patients per arm are required in an unselected sampled population and 185 patients per arm are required in a selected population. Within a 6-month period, significant atrophy can be detected and on-study associations of PBVC and PBHs emphasizes axonal loss to be a driving mechanism. Application as primary outcome measure in short-term clinical trials with feasible sample size requires a potent drug to obtain sufficient power. (orig.)

  20. Measuring and reporting quality of life outcomes in clinical trials in cystic fibrosis: a critical review

    Directory of Open Access Journals (Sweden)

    Hart Anna

    2005-03-01

    Full Text Available Abstract Good quality clinical trials are essential to inform the best cystic fibrosis (CF management and care, by determining and comparing the effectiveness of new and existing therapies and drug delivery systems. The formal inclusion of quality of life (QoL as an outcome measure in CF clinical trials is becoming more common. Both an appropriate QoL measure and sound methodology are required in order to draw valid inferences about treatments and QoL. A review was undertaken of randomised controlled trials in cystic fibrosis where QoL was measured. EMBASE, MEDLINE and ISI Web of Science were searched to locate all full papers in the English language reporting randomised controlled trials in cystic fibrosis, published between January 1991 and December 2004. All Cochrane reviews published before December 2004 were hand searched. Papers were included if the authors had reported that they had measured QoL or well being in the trial. 16 trials were identified. The interventions investigated were: antibiotics (4; home versus hospital administration of antibiotics (1; steroids (1; mucolytic therapies (6; exercise (3 and pancreatic enzymes (1. Not one trial evaluated in this review provided conclusive results concerning QoL. This review highlights many of the pitfalls of QoL measurement in CF clinical trials and provides constructive information concerning the design and reporting of trials measuring QoL.

  1. Are process performance measures associated with clinical outcomes among patients with hip fractures?

    DEFF Research Database (Denmark)

    Kristensen, Pia Kjaer; Thillemann, Theis Muncholm; Søballe, Kjeld;

    2016-01-01

    OBJECTIVES: To examine the association between process performance measures and clinical outcome among patients with hip fracture. DESIGN: Nationwide, population-based follow-up study. SETTING: Public Danish hospitals. PARTICIPANTS: A total of 25 354 patients 65 years or older who were admitted...... and length of stay (LOS). RESULTS: Fulfilling 75-100% of the relevant process performance measures was associated with lower 30-day mortality (22.6% vs. 8.5%, adjusted odds ratio (OR) 0.31 (95% CI: 0.28-0.35)) and lower odds for readmission (21.7% vs. 17.4%, adjusted OR 0.78 (95% CI: 0.70-0.87)). The overall...... with a hip fracture in Denmark between 2010 and 2013. INTERVENTION: The process performance measures, including systematic pain assessment, early mobilization, basic mobility assessment at arrival and at discharge, post-discharge rehabilitation program, anti-osteoporotic medication and prevention of future...

  2. Measurement-based Treatment of Residual Symptoms Using Clinically Useful Depression Outcome Scale: Korean Validation Study

    Science.gov (United States)

    Jeon, Sang Won; Han, Changsu; Ko, Young-Hoon; Yoon, Seo Young; Pae, Chi-Un; Choi, Joonho; Park, Yong Chon; Kim, Jong-Woo; Yoon, Ho-Kyoung; Ko, Seung-Duk; Patkar, Ashwin A.; Zimmerman, Mark

    2017-01-01

    Objective This study was aimed at evaluating the diagnostic validity of the Korean version of the Clinically Useful Depression Outcome Scale (CUDOS) with varying follow-up in a typical clinical setting in multiple centers. Methods In total, 891 psychiatric outpatients were enrolled at the time of their intake appointment. Current diagnostic characteristics were examined using the Structured Clinical Interview for DSM-IV (41% major depressive disorder). The CUDOS was measured and compared with three clinician rating scales and four self-report scales. Results The CUDOS showed excellent results for internal consistency (Cronbach’s α, 0.91), test-retest reliability (patients at intake, r=0.81; depressed patients in ongoing treatment, r=0.89), and convergent and discriminant validity (measures of depression, r=0.80; measures of anxiety and somatization, r=0.42). The CUDOS had a high ability to discriminate between different levels of depression severity based on the rating of Clinical Global Impression for depression severity and the diagnostic classification of major depression, minor depression, and non-depression. The ability of the CUDOS to identify patients with major depression was high (area under the receiver operating characteristic curve=0.867). A score of 20 as the optimal cutoff point was suggested when screening for major depression using the CUDOS (sensitivity=89.9%, specificity=69.5%). The CUDOS was sensitive to change after antidepressant treatment: patients with greater improvement showed a greater decrease in CUDOS scores (pKorean version of the CUDOS is a very useful measurement for research and for clinical practice. PMID:28138107

  3. The Role of Clinical and Instrumented Outcome Measures in Balance Control of Individuals with Multiple Sclerosis

    Directory of Open Access Journals (Sweden)

    Neeta Kanekar

    2013-01-01

    Full Text Available Purpose. The aim of the study was to investigate differences in balance control between individuals with multiple sclerosis (MS and healthy control subjects using clinical scales and instrumented measures of balance and determine relationships between balance measures, fatigue, and disability levels in individuals with MS with and without a history of falls. Method. Twelve individuals with MS and twelve healthy controls were evaluated using the Berg Balance and Activities-specific Balance Confidence Scales, Modified Clinical Test of Sensory Interaction on Balance, and Limits of Stability Tests as well as Fatigue Severity Scale and Barthel Index. Results. Mildly affected individuals with MS had significant balance performance deficits and poor balance confidence levels (P<0.05. MS group had higher sway velocities and diminished stability limits (P<0.05, significant sensory impairments, high fatigue and disability levels (P<0.05. Sway velocity was a significant predictor of balance performance and the ability to move towards stability limits for the MS group. For the MS-fallers group, those with lower disability levels had faster movement velocities and better balance performance. Conclusion. Implementation of both clinical and instrumented tests of balance is important for the planning and evaluation of treatment outcomes in balance rehabilitation of people with MS.

  4. Proposed outcome measures for prospective clinical trials in juvenile idiopathic arthritis-associated uveitis

    DEFF Research Database (Denmark)

    Heiligenhaus, Arnd; Foeldvari, Ivan; Edelsten, Clive

    2012-01-01

    To develop a set of core outcome measures for use in randomized controlled trials (RCTs) and longitudinal observational studies in juvenile idiopathic arthritis (JIA)-associated uveitis.......To develop a set of core outcome measures for use in randomized controlled trials (RCTs) and longitudinal observational studies in juvenile idiopathic arthritis (JIA)-associated uveitis....

  5. Clinical validity of outcome pain measures in naturally occurring canine osteoarthritis

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    Rialland Pascale

    2012-09-01

    Full Text Available Abstract Background The conceptual validity of kinetic gait analysis and disability outcome assessment methods has guided their use in the assessment of pain caused by osteoarthritis (OA. No consensus on the best clinical methods for pain evaluation in canine OA exists, particularly, when evaluating treatments where a smaller treatment effect is anticipated than with pharmacological pain killers. This study thus aimed at determining the technical validity of some clinical endpoints on OA pain in dogs using the green-lipped mussel (GLM-enriched diet. Twenty-three adult dogs with clinical OA completed the prospective controlled study. All the dogs were fed a balanced diet over a 30-day control period followed by a GLM-enriched diet over a 60-day period. The kinetic gait analysis parameter (PVFBW, peak vertical force adjusted for body weight change, electrodermal activity (EDA, and a standardized multifactorial pain questionnaire (MFQ were performed on day (D 0 (inclusion, D30 (start and D90 (end. The owners completed a client-specific outcome measures (CSOM instrument twice a week. Motor activity (MA was continuously recorded in seven dogs using telemetered accelerometric counts. We hypothesized that these methods would produce convergent results related to diet changes. A Type I error of 0.05 was adjusted to correct for the multiplicity of the primary clinical endpoints. Results Neither the EDA nor the MFQ were found reliable or could be validated. Changes in the PVFBW (Padj = 0.0004, the CSOM (Padj = 0.006 and the MA intensity (Padj = 0.02 from D0 to D90 suggested an effect of diet(s. Only the PVFBW clearly increased after the GLM-diet (Padj = 0.003. The CSOM exhibited a negative relationship with the PVFBW (P = 0.02 and MA duration (P = 0.02. Conclusions The PVFBW exhibited the best technical validity for the characterization of the beneficial effect of a GLM-enriched diet. The CSOM and MA appeared less responsive

  6. A systematic review of studies that aim to determine which outcomes to measure in clinical trials in children.

    Directory of Open Access Journals (Sweden)

    Ian Sinha

    2008-04-01

    Full Text Available BACKGROUND: In clinical trials the selection of appropriate outcomes is crucial to the assessment of whether one intervention is better than another. Selection of inappropriate outcomes can compromise the utility of a trial. However, the process of selecting the most suitable outcomes to include can be complex. Our aim was to systematically review studies that address the process of selecting outcomes or outcome domains to measure in clinical trials in children. METHODS AND FINDINGS: We searched Cochrane databases (no date restrictions in December 2006; and MEDLINE (1950 to 2006, CINAHL (1982 to 2006, and SCOPUS (1966 to 2006 in January 2007 for studies of the selection of outcomes for use in clinical trials in children. We also asked a group of experts in paediatric clinical research to refer us to any other relevant studies. From these articles we extracted data on the clinical condition of interest, description of the method used to select outcomes, the people involved in the selection process, the outcomes selected, and limitations of the method as defined by the authors. The literature search identified 8,889 potentially relevant abstracts. Of these, 70 were retrieved, and 25 were included in the review. These studies described the work of 13 collaborations representing various paediatric specialties including critical care, gastroenterology, haematology, psychiatry, neurology, respiratory paediatrics, rheumatology, neonatal medicine, and dentistry. Two groups utilised the Delphi technique, one used the nominal group technique, and one used both methods to reach a consensus about which outcomes should be measured in clinical trials. Other groups used semistructured discussion, and one group used a questionnaire-based survey. The collaborations involved clinical experts, research experts, and industry representatives. Three groups involved parents of children affected by the particular condition. CONCLUSIONS: Very few studies address the

  7. Fibromyalgia syndrome: review of clinical presentation, pathogenesis, outcome measures, and treatment.

    Science.gov (United States)

    Mease, Philip

    2005-08-01

    Fibromyalgia syndrome (FM) is a common chronic pain condition that affects at least 2% of the adult population in the USA and other regions in the world where FM is studied. Prevalence rates in some regions have not been ascertained and may be influenced by differences in cultural norms regarding the definition and attribution of chronic pain states. Chronic, widespread pain is the defining feature of FM, but patients may also exhibit a range of other symptoms, including sleep disturbance, fatigue, irritable bowel syndrome, headache, and mood disorders. Although the etiology of FM is not completely understood, the syndrome is thought to arise from influencing factors such as stress, medical illness, and a variety of pain conditions in some, but not all patients, in conjunction with a variety of neurotransmitter and neuroendocrine disturbances. These include reduced levels of biogenic amines, increased concentrations of excitatory neurotransmitters, including substance P, and dysregulation of the hypothalamic-pituitary-adrenal axis. A unifying hypothesis is that FM results from sensitization of the central nervous system. Establishing diagnosis and evaluating effects of therapy in patients with FM may be difficult because of the multifaceted nature of the syndrome and overlap with other chronically painful conditions. Diagnostic criteria, originally developed for research purposes, have aided our understanding of this patient population in both research and clinical settings, but need further refinement as our knowledge about chronic widespread pain evolves. Outcome measures, borrowed from clinical research in pain, rheumatology, neurology, and psychiatry, are able to distinguish treatment response in specific symptom domains. Further work is necessary to validate these measures in FM. In addition, work is under way to develop composite response criteria, intended to address the multidimensional nature of this syndrome. A range of medical treatments, including

  8. Recommendations for a first Core Outcome Measurement set for complex regional PAin syndrome Clinical sTudies (COMPACT).

    Science.gov (United States)

    Grieve, Sharon; Perez, Roberto Sgm; Birklein, Frank; Brunner, Florian; Bruehl, Stephen; Harden, R Norman; Packham, Tara; Gobeil, Francois; Haigh, Richard; Holly, Janet; Terkelsen, Astrid; Davies, Lindsay; Lewis, Jennifer; Thomassen, Ilona; Connett, Robyn; Worth, Tina; Vatine, Jean-Jacques; McCabe, Candida S

    2017-02-04

    Complex Regional Pain Syndrome (CRPS) is a persistent pain condition that remains incompletely understood and challenging to treat. Historically, a wide range of different outcome measures have been used to capture the multidimensional nature of CRPS. This has been a significant limiting factor in the advancement of our understanding of the mechanisms and management of CRPS.In 2013, an international consortium of patients, clinicians, researchers and industry representatives was established, to develop and agree on a minimum core set of standardised outcome measures for use in future CRPS clinical research, including but not limited to clinical trials within adult populationsThe development of a core measurement set was informed through workshops and supplementary work, using an iterative consensus process. 'What is the clinical presentation and course of CRPS, and what factors influence it?' was agreed as the most pertinent research question that our standardised set of patient-reported outcome measures should be selected to answer. The domains encompassing the key concepts necessary to answer the research question were agreed as: pain, disease severity, participation and physical function, emotional and psychological function, self efficacy, catastrophizing and patient's global impression of change. The final core measurement set included the optimum generic or condition-specific patient-reported questionnaire outcome measures, which captured the essence of each domain, and one clinician reported outcome measure to capture the degree of severity of CRPS. The next step is to test the feasibility and acceptability of collecting outcome measure data using the core measurement set in the CRPS population internationally.

  9. From clinically relevant outcome measures to quality of life in epilepsy : A time trade-off study

    NARCIS (Netherlands)

    de Kinderen, Reina J A; Wijnen, Ben F M; van Breukelen, Gerard; Postulart, Debby; Majoie, Marian H J M; Aldenkamp, Albert P; Evers, Silvia M A A

    2016-01-01

    OBJECTIVES: A proposed method for bridging the gap between clinically relevant epilepsy outcome measures and quality-adjusted life years is to derive utility scores for epilepsy health states. The aim of this study is to develop such a utility-function and to investigate the impact of the epilepsy o

  10. Core outcome domains and measures for pediatric acute and chronic/recurrent pain clinical trials : PedIMMPACT recommendations

    NARCIS (Netherlands)

    McGrath, Patrick J.; Walco, Gary A.; Turk, Dennis C.; Dworkin, Robert H.; Brown, Mark T.; Davidson, Karina; Eccleston, Christopher; Finley, G. Allen; Goldschneider, Kenneth; Haverkos, Lynne; Hertz, Sharon H.; Ljungman, Gustaf; Palermo, Tonya; Rappaport, Bob A.; Rhodes, Thomas; Schechter, Neil; Scott, Jane; Sethna, Navil; Svensson, Ola K.; Stinson, Jennifer; von Baeyer, Carl L.; Walker, Lynn; Weisman, Steven; White, Richard E.; Zajicek, Anne; Zeltzer, Lonnie

    2008-01-01

    Under the auspices of the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT), 26 professionals from academia, governmental agencies, and the pharmaceutical industry participated in a 2-stage Delphi poll and a consensus meeting that identified core outcome domains an

  11. Clinical Utility of the Modified Stroop Task as a Treatment Outcome Measure: Questions Raised

    Science.gov (United States)

    Ball, Jillian R.; Mitchell, Philip B.; Touyz, Stephen W.; Griffiths, Rosalyn A.; Beumont, Pierre J. V.

    2004-01-01

    Data from an outpatient treatment trial for anorexia nervosa were examined to gain preliminary insights as to whether the modified Stroop colour-naming task might offer a useful measure of treatment outcome. It was hypothesised that interference for eating-, weight- and shape-related words on a modified version on the Stroop colour-naming task…

  12. Relationship between psychiatric status, self-reported outcome measures, and clinical parameters in axial spondyloarthritis.

    Science.gov (United States)

    Kilic, Gamze; Kilic, Erkan; Ozgocmen, Salih

    2014-12-01

    This article aims to compare the risks of depression and anxiety in patients with ankylosing spondylitis (AS) and nonradiographic axial spondyloarthritis (nr-axSpA) and investigate the relationship among self-reported outcome measures, clinical parameters, and physical variables of patients with axSpA. Patients with axSpA were recruited from Erciyes Spondyloarthritis Cohort. The patients met Assessment of Spondyloarthritis International Society classification criteria for axial SpA and were assessed in a cross-sectional study design for visual analog scale (VAS) pain, Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), Bath Ankylosing Spondylitis Functional Index (BASFI), Ankylosing Spondylitis Quality of Life questionnaire (ASQoL), and Ankylosing Spondylitis Disease Activity Score-C-reactive protein (ASDAS-CRP). Psychological status was evaluated using the hospital anxiety and depression scale (HADS). Multivariate logistic regression analysis was applied to determine the associations between psychological variables and clinical parameters after adjusting for confounding variables. Of the 316 patients (142 nr-axSpA, 174 AS), 139 (44%) had high risk for depression (HADS-D score ≥ 7) and 71 (22.5%) for anxiety (HADS-A score ≥ 10). HADS-D and HADS-A scores were similar between patients with AS and nr-axSpA. Patients with high risk for depression and anxiety had higher scores in BASDAI, BASFI, and ASDAS-CRP, and also poorer scores in VAS pain and ASQoL. Multivariate logistic regression analysis showed that the ASDAS-CRP, ASQoL, BASDAI, as well as educational level were factors associated with the risk of depression whereas the ASQoL and educational level were factors associated with the risk of anxiety. Patients with nr-axSpA and AS have similar burden of psychological distress. The quality of life (ASQoL) and educational level were factors associated with the risk of both depression and anxiety whereas disease activity (BASDAI and ASDAS-CRP) was the

  13. Capillaroscopy as an Outcome Measure for Clinical Trials on the Peripheral Vasculopathy in SSc—Is It Useful?

    Directory of Open Access Journals (Sweden)

    Maurizio Cutolo

    2010-01-01

    Full Text Available Peripheral microvascular impairment in systemic sclerosis (SSc may be easily detected and scored in a safe noninvasive way by nailfold videocapillaroscopy (NVC. The paper highlights clinical conditions related to SSc in which NVC may represent an outcome measure of therapeutical interventions, by elaborating on their already assessed relationship with the NVC patterns and eventually scores. The 3 important biological/clinical conditions are: the positivity for SSc-specific serum autoantibodies, the presence of SSc skin digital ulcers (DUs and of pulmonary arterial hypertension (PAH SSc associated. In conclusion, to the question if capillaroscopy (NVC may represent in SSc an outcome measure for clinical trials on the peripheral vasculopathy, based on the growing evidence and our detailed studies, the answer is positive. Recent therapeutic trials in SSc are confirming this role, and the experience is growing rapidly.

  14. Social and behavioral research in genomic sequencing: approaches from the Clinical Sequencing Exploratory Research Consortium Outcomes and Measures Working Group.

    Science.gov (United States)

    Gray, Stacy W; Martins, Yolanda; Feuerman, Lindsay Z; Bernhardt, Barbara A; Biesecker, Barbara B; Christensen, Kurt D; Joffe, Steven; Rini, Christine; Veenstra, David; McGuire, Amy L

    2014-10-01

    The routine use of genomic sequencing in clinical medicine has the potential to dramatically alter patient care and medical outcomes. To fully understand the psychosocial and behavioral impact of sequencing integration into clinical practice, it is imperative that we identify the factors that influence sequencing-related decision making and patient outcomes. In an effort to develop a collaborative and conceptually grounded approach to studying sequencing adoption, members of the National Human Genome Research Institute's Clinical Sequencing Exploratory Research Consortium formed the Outcomes and Measures Working Group. Here we highlight the priority areas of investigation and psychosocial and behavioral outcomes identified by the Working Group. We also review some of the anticipated challenges to measurement in social and behavioral research related to genomic sequencing; opportunities for instrument development; and the importance of qualitative, quantitative, and mixed-method approaches. This work represents the early, shared efforts of multiple research teams as we strive to understand individuals' experiences with genomic sequencing. The resulting body of knowledge will guide recommendations for the optimal use of sequencing in clinical practice.

  15. Outcome measures of antidepressive therapy.

    Science.gov (United States)

    Rosenberg, R

    2000-01-01

    A variety of outcome measures assessing antidepressive therapy are available. However, in randomized clinical trials, the Hamilton Rating Scale for Depression (HAM-D) is often the primary outcome measure. Results from factor analysis and Rasch item analysis indicate that the HAM-D is heterogeneous and that the sum of items scores may not be an adequate measure of the severity of depression. A Melancholia Scale of 11 items has been suggested as a more valid measure of the core symptoms of affective syndrome. Other global outcome measures, focusing on health-related quality of life issues and on social functioning as well as macro-economic analyses are also used in depression. Applying stringent and well-documented outcome measures in randomized clinical trials of antidepressants may give the clinician a better indication of the most appropriate drug for treatment of the individual patient.

  16. Usefulness of the Core Outcome Measures Index in Daily Clinical Practice for Assessing Patients with Degenerative Lumbar Disease

    Directory of Open Access Journals (Sweden)

    Carlos Lozano-Álvarez

    2012-01-01

    Full Text Available Introduction. Outcome evaluation is an important aspect of the treatment of patients with degenerative lumbar disease. We evaluated the usefulness of the Core Outcome Measures Index (COMI in assessing people affected by degenerative lumbar disease in daily clinical practice. Methods. We evaluated 221 patients who had completed preoperatively and 2 years after surgery VAS pain, Short Form-36 (SF-36, Oswestry Disability Index (ODI and COMI. We calculated the change of scores and its sensitivity to change. The internal consistency of the COMI items and the correlation between the COMI scores and the scores of the other measurements were assessed. Results. Statistically significant differences were observed between the mean scores of the preoperative and 2 years questionnaires for nearly all measurements. COMI showed a good internal consistency, except for the preoperative pain subscale. The sensitivity to change was high for the total COMI and its pain and well-being subscales and moderate for the rest. The COMI demonstrated strong correlation with the other measurements. Conclusions. The COMI is a useful tool for assessing the patient-based outcome in the studied population. Given its simplicity, good correlation with the SF-36 and ODI and its good sensitivity to change, it could replace more cumbersome instruments in daily clinical practice.

  17. Clinical Evaluation of a Mobile Sensor-Based Gait Analysis Method for Outcome Measurement after Knee Arthroplasty

    Directory of Open Access Journals (Sweden)

    Tilman Calliess

    2014-08-01

    Full Text Available Clinical scores and motion-capturing gait analysis are today’s gold standard for outcome measurement after knee arthroplasty, although they are criticized for bias and their ability to reflect patients’ actual quality of life has been questioned. In this context, mobile gait analysis systems have been introduced to overcome some of these limitations. This study used a previously developed mobile gait analysis system comprising three inertial sensor units to evaluate daily activities and sports. The sensors were taped to the lumbosacral junction and the thigh and shank of the affected limb. The annotated raw data was evaluated using our validated proprietary software. Six patients undergoing knee arthroplasty were examined the day before and 12 months after surgery. All patients reported a satisfactory outcome, although four patients still had limitations in their desired activities. In this context, feasible running speed demonstrated a good correlation with reported impairments in sports-related activities. Notably, knee flexion angle while descending stairs and the ability to stop abruptly when running exhibited good correlation with the clinical stability and proprioception of the knee. Moreover, fatigue effects were displayed in some patients. The introduced system appears to be suitable for outcome measurement after knee arthroplasty and has the potential to overcome some of the limitations of stationary gait labs while gathering additional meaningful parameters regarding the force limits of the knee.

  18. Clinical evaluation of a mobile sensor-based gait analysis method for outcome measurement after knee arthroplasty.

    Science.gov (United States)

    Calliess, Tilman; Bocklage, Raphael; Karkosch, Roman; Marschollek, Michael; Windhagen, Henning; Schulze, Mareike

    2014-08-28

    Clinical scores and motion-capturing gait analysis are today's gold standard for outcome measurement after knee arthroplasty, although they are criticized for bias and their ability to reflect patients' actual quality of life has been questioned. In this context, mobile gait analysis systems have been introduced to overcome some of these limitations. This study used a previously developed mobile gait analysis system comprising three inertial sensor units to evaluate daily activities and sports. The sensors were taped to the lumbosacral junction and the thigh and shank of the affected limb. The annotated raw data was evaluated using our validated proprietary software. Six patients undergoing knee arthroplasty were examined the day before and 12 months after surgery. All patients reported a satisfactory outcome, although four patients still had limitations in their desired activities. In this context, feasible running speed demonstrated a good correlation with reported impairments in sports-related activities. Notably, knee flexion angle while descending stairs and the ability to stop abruptly when running exhibited good correlation with the clinical stability and proprioception of the knee. Moreover, fatigue effects were displayed in some patients. The introduced system appears to be suitable for outcome measurement after knee arthroplasty and has the potential to overcome some of the limitations of stationary gait labs while gathering additional meaningful parameters regarding the force limits of the knee.

  19. Assessing methods for measurement of clinical outcomes and quality of care in primary care practices

    Directory of Open Access Journals (Sweden)

    Green Michael E

    2012-07-01

    Full Text Available Abstract Purpose To evaluate the appropriateness of potential data sources for the population of performance indicators for primary care (PC practices. Methods This project was a cross sectional study of 7 multidisciplinary primary care teams in Ontario, Canada. Practices were recruited and 5-7 physicians per practice agreed to participate in the study. Patients of participating physicians (20-30 were recruited sequentially as they presented to attend a visit. Data collection included patient, provider and practice surveys, chart abstraction and linkage to administrative data sets. Matched pairs analysis was used to examine the differences in the observed results for each indicator obtained using multiple data sources. Results Seven teams, 41 physicians, 94 associated staff and 998 patients were recruited. The survey response rate was 81% for patients, 93% for physicians and 83% for associated staff. Chart audits were successfully completed on all but 1 patient and linkage to administrative data was successful for all subjects. There were significant differences noted between the data collection methods for many measures. No single method of data collection was best for all outcomes. For most measures of technical quality of care chart audit was the most accurate method of data collection. Patient surveys were more accurate for immunizations, chronic disease advice/information dispensed, some general health promotion items and possibly for medication use. Administrative data appears useful for indicators including chronic disease diagnosis and osteoporosis/ breast screening. Conclusions Multiple data collection methods are required for a comprehensive assessment of performance in primary care practices. The choice of which methods are best for any one particular study or quality improvement initiative requires careful consideration of the biases that each method might introduce into the results. In this study, both patients and providers were

  20. Association study of dysbindin gene with clinical and outcome measures in a representative cohort of Italian schizophrenic patients.

    Science.gov (United States)

    Tosato, Sarah; Ruggeri, Mirella; Bonetto, Chiara; Bertani, Mariaelena; Marrella, Giovanna; Lasalvia, Antonio; Cristofalo, Doriana; Aprili, Giuseppe; Tansella, Michele; Dazzan, Paola; Diforti, Marta; Murray, Robin M; Collier, David A

    2007-07-05

    There is evidence suggesting that Dysbindin (DTNBP1) is a susceptibility gene for schizophrenia in Caucasian, Chinese, and Japanese populations. We sought to determine if dysbindin was associated with schizophrenia and its symptoms in a representative group of schizophrenic patients from a Community-Based Mental Health Service (CMHS) in Verona, Italy. A prevalence cohort of schizophrenic patients (n = 141) was assessed at baseline and then 3 and 6 years later. Eighty patients and 106 healthy controls were genotyped for polymorphisms in dysbindin. We tested if diagnosis, clinical symptoms as measured by the Brief Psychiatric Rating Scale (BPRS), and functioning as measured by the Global Assessment of Functioning Scale (GAF), were associated with the presence of certain dysbindin polymorphisms. Finally, using the longitudinal clinical data, we tested if patients carrying dysbindin high-risk haplotypes had a more unfavorable longitudinal clinical outcome. A trend towards statistical association (P = 0.058) between schizophrenia and rs2619538 was found. Using GENECOUNTING software, we found that rs2619538-P1583 (P = 0.048), P1320-P1757 (P = 0.034), and rs2619538-P1583-P1578 (P = 0.040) haplotypes occurred more often in cases compared to controls before correction for multiple testing. The rs2619538-P1583 haplotype was more likely to be transmitted to subjects with more severe and persistent psychopathology. These preliminary results are compatible with the view that DTNBP1 is a susceptibility factor for schizophrenia, and is associated with worse psychopathology.

  1. Incorporating longitudinal pediatric patient-centered outcome measurement into the clinical workflow using a commercial electronic health record: a step toward increasing value for the patient.

    Science.gov (United States)

    Carberry, Kathleen; Landman, Zachary; Xie, Michelle; Feeley, Thomas; Henderson, John; Fraser, Charles

    2016-01-01

    Patient-centered outcomes measurement provides healthcare organizations with crucial information for increasing value for patients; however, organizations have struggled to obtain outcomes data from electronic health record (EHR) systems. This study describes how Texas Children's Hospital customized a commercial EHR system and assembled a cross-functional team to capture outcomes data using existing functionality. Prior to its installation and customization, no surgical subspecialties besides the congenital heart and transplant surgery groups conducted prospective, patient outcomes measurement, but by 2015, the outcomes of over 1300 unique patients with supracondylar fractures, cleft lip and/or palate, or voiding dysfunction had been tracked. Key factors for integrating outcomes measurement into the clinical workflow include ongoing communication between cross-functional teams composed of clinicians and technical professionals, an iterative design process, organizational commitment, and prioritizing measurement as early as possible during EHR optimization.

  2. Associations among Measures of Engagement with KP.Org and Clinical Outcomes

    Science.gov (United States)

    Sobko, Heather J.

    2011-01-01

    Introduction. The purpose of this retrospective cohort study was to examine patterns of use of an electronic personal health record among adults diagnosed with diabetes, hypertension or hyperlipidemia. Intermediate behavioral measures (medication possession ratios) and physiological measures of metabolic control for diabetes (hemoglobinA1c),…

  3. Outcome Rating Scale and Session Rating Scale in Psychological Practice: Clinical Utility of Ultra-Brief Measures

    Science.gov (United States)

    Campbell, Alistair; Hemsley, Samantha

    2009-01-01

    The validity and reliability of the Outcome Rating Scale (ORS) and the Session Rating Scale (SRS) were evaluated against existing longer measures, including the Outcome Questionnaire-45, Working Alliance Inventory, Depression Anxiety Stress Scale-21, Quality of Life Scale, Rosenberg Self-Esteem Scale and General Self-efficacy Scale. The measures…

  4. Identifying the concepts contained in outcome measures of clinical trials on four internal disorders using the international classification of functioning, disability and health as a reference

    OpenAIRE

    2004-01-01

    Objectives: To systematically identify and compare the concepts contained in outcome measures of clinical trials on chronic ischemic heart disease, diabetes mellitus, obesity and obstructive pulmonary disease, including asthma using the International Classification of Functioning, Disability and Health (ICF) as a reference. Methods: Randomized controlled trials between 1993 and 2003 were located in MEDLINE and selected according predefined criteria. The outcome measures were extracted and...

  5. Development and measurement properties of the Orthotics and Prosthetics Users' Survey (OPUS): a comprehensive set of clinical outcome instruments.

    Science.gov (United States)

    Heinemann, A W; Bode, R K; O'Reilly, C

    2003-12-01

    The need to measure and evaluate orthotics and prosthetics (O&P) practice has received growing recognition in the past several years. Reliable and valid self-report instruments are needed that can help facilities evaluate patient outcomes. The objective of this project was to develop a set of self-report instruments that assess functional status, quality of life, and satisfaction with devices and services that can be used in an orthotics and prosthetics clinic. Selecting items from a variety of existing instruments, the authors developed and revised four instruments that differentiate patients with varying levels of lower limb function, quality of life, and satisfaction with devices and services. Evidence of construct validity is provided by hierarchies of item difficulty that are consistent with clinical experience. For example, with the lower limb function instrument, running one block was much more difficult than walking indoors. The instruments demonstrate adequate internal consistency (0.88 for lower limb function, 0.88 for quality of life, 0.74 for service satisfaction, 0.78 for device satisfaction). The next steps in their research programme are to evaluate sensitivity and construct validity. The Orthotics and Prosthetics Users' Survey (OPUS) is a promising self-report instrument which may, with further development, allow orthotic and prosthetic practitioners to evaluate the quality and effectiveness of their services as required by accreditation standards such as those of the American Board for Certification in Orthotics and Prosthetics that mandate quality assessment.

  6. A clinical study on ultrasonographic measurement of cervical length at 18-24 weeks of gestation and pregnancy outcome

    Directory of Open Access Journals (Sweden)

    Jayati Nath

    2016-04-01

    Conclusions: Shorter cervices lead to shorter gestations and early labour. Thus ultrasonographic measurement of cervical length at 18-24 weeks of gestation is very important, more so in asymptomatic women and can be utilized as a tool for predicting adverse pregnancy outcome especially preterm labour and delivery. [Int J Reprod Contracept Obstet Gynecol 2016; 5(4.000: 1088-1092

  7. Defining the effect and mediators of two knowledge translation strategies designed to alter knowledge, intent and clinical utilization of rehabilitation outcome measures: a study protocol [NCT00298727

    Directory of Open Access Journals (Sweden)

    Law Mary

    2006-07-01

    Full Text Available Abstract Background A substantial number of valid outcome measures have been developed to measure health in adult musculoskeletal and childhood disability. Regrettably, national initiatives have merely resulted in changes in attitude, while utilization remains unacceptably low. This study will compare the effectiveness and mediators of two different knowledge transfer (KT interventions in terms of their impact on changing knowledge and behavior (utilization and clinical reasoning related to health outcome measures. Method/Design Physical and occupational therapists (n = 144 will be recruited in partnership with the national professional associations to evaluate two different KT interventions with the same curriculum: 1 Stakeholder-Hosted Interactive Problem-Based Seminar (SHIPS, and 2 Online Problem-Based course (e-PBL. SHIPS will consist of face-to-face problem-based learning (PBL for 2 1/2 days with outcome measure developers as facilitators, using six problems generated in consultation with participants. The e-PBL will consist of a 6-week web-based course with six generic problems developed by content experts. SHIPS will be conducted in three urban centers in Canada. Participants will be block-allocated by a minimization procedure to either of the two interventions to minimize any prognostic differences. Trained evaluators at each site will conduct chart audits and chart-stimulated recall. Trained interviewers will conduct semi-structured interviews focused on identifying critical elements in KT and implementing practice changes. Interviews will be transcribed verbatim. Baseline predictors including demographics, knowledge, attitudes/barriers regarding outcome measures, and Readiness to Change will be assessed by self-report. Immediately post-intervention and 6 months later, these will be re-administered. Primary qualitative and quantitative evaluations will be conducted 6-months post-intervention to assess the relative effectiveness of KT

  8. Selecting magnetic resonance imaging (MRI) outcome measures for juvenile idiopathic arthritis (JIA) clinical trials: first report of the MRI in JIA special interest group.

    Science.gov (United States)

    Hemke, Robert; Doria, Andrea S; Tzaribachev, Nikolay; Maas, Mario; van der Heijde, Désirée M F M; van Rossum, Marion A J

    2014-02-01

    Recent advances in magnetic resonance imaging (MRI) techniques have substantially improved the evaluation of joint pathologies in juvenile idiopathic arthritis (JIA). Because of the current availability of highly effective antirheumatic therapies and the unique and useful features of MRI, there is a growing need for an accurate and reproducible MRI assessment scoring system for JIA, such as the rheumatoid arthritis MRI Scoring (RAMRIS) for patients with rheumatoid arthritis (RA). To effectively evaluate the efficacy of treatment in clinical research trials, we need to develop and validate scoring methods to accurately measure joint outcomes, standardize imaging protocols for data acquisition and interpretation, and create imaging atlases to differentiate physiologic and pathologic joint findings in childhood and adolescence. Such a standardized, validated, JIA-MRI scoring method could be used as an outcome measure in clinical trials.

  9. Patient-reported outcome measures for systemic lupus erythematosus clinical trials: a review of content validity, face validity and psychometric performance

    OpenAIRE

    Holloway, Laura; Humphrey, Louise; Heron, Louise; Pilling, Claire; Kitchen, Helen; Højbjerre, Lise; Strandberg-Larsen, Martin; Hansen, Brian Bekker

    2014-01-01

    Background Despite overall progress in treatment of autoimmune diseases, patients with systemic lupus erythematosus (SLE) experience many inflammatory symptoms representing an unmet medical need. This study aimed to create a conceptual model of the humanistic and economic burden of SLE, and review the patient-reported outcomes (PROs) used to measure such concepts in SLE clinical trials. Methods A conceptual model for SLE was developed from structured review of published articles from 2007 to ...

  10. Selected items from the Charcot-Marie-Tooth (CMT) Neuropathy Score and secondary clinical outcome measures serve as sensitive clinical markers of disease severity in CMT1A patients.

    Science.gov (United States)

    Mannil, Manoj; Solari, Alessandra; Leha, Andreas; Pelayo-Negro, Ana L; Berciano, José; Schlotter-Weigel, Beate; Walter, Maggie C; Rautenstrauss, Bernd; Schnizer, Tuuli J; Schenone, Angelo; Seeman, Pavel; Kadian, Chandini; Schreiber, Olivia; Angarita, Natalia G; Fabrizi, Gian Maria; Gemignani, Franco; Padua, Luca; Santoro, Lucio; Quattrone, Aldo; Vita, Giuseppe; Calabrese, Daniela; Young, Peter; Laurà, Matilde; Haberlová, Jana; Mazanec, Radim; Paulus, Walter; Beissbarth, Tim; Shy, Michael E; Reilly, Mary M; Pareyson, Davide; Sereda, Michael W

    2014-11-01

    This study evaluates primary and secondary clinical outcome measures in Charcot-Marie-Tooth disease type 1A (CMT1A) with regard to their contribution towards discrimination of disease severity. The nine components of the composite Charcot-Marie-Tooth disease Neuropathy Score and six additional secondary clinical outcome measures were assessed in 479 adult patients with genetically proven CMT1A and 126 healthy controls. Using hierarchical clustering, we identified four significant clusters of patients according to clinical severity. We then tested the impact of each of the CMTNS components and of the secondary clinical parameters with regard to their power to differentiate these four clusters. The CMTNS components ulnar sensory nerve action potential (SNAP), pin sensibility, vibration and strength of arms did not increase the discriminant value of the remaining five CMTNS components (Ulnar compound motor action potential [CMAP], leg motor symptoms, arm motor symptoms, leg strength and sensory symptoms). However, three of the six additional clinical outcome measures - the 10m-timed walking test (T10MW), 9 hole-peg test (9HPT), and foot dorsal flexion dynamometry - further improved discrimination between severely and mildly affected patients. From these findings, we identified three different composite measures as score hypotheses and compared their discriminant power with that of the CMTNS. A composite of eight components CMAP, Motor symptoms legs, Motor symptoms arms, Strength of Legs, Sensory symptoms), displayed the strongest power to discriminate between the clusters. As a conclusion, five items from the CMTNS and three secondary clinical outcome measures improve the clinical assessment of patients with CMT1A significantly and are beneficial for upcoming clinical and therapeutic trials.

  11. Quality of Life in Knee Osteoarthritis; Correlation with Clinical Measures and the Knee Injury and Osteoarthritis Outcome Score

    Directory of Open Access Journals (Sweden)

    Mehmet Atıf Erol Aksekili

    2016-03-01

    Full Text Available INTRODUCTION: Osteoarthritis (OA, the most common degenerative joint disorder, affects the quality of lives (QoL of the sufferers as other chronic disorders. Therefore assessment of QOL is of particular importance. In this study we aimed to evaluate the quality of life (QoL in patients with knee osteoarthritis by using the Nottingham Health Profile (NHP and to determine its relationships with disability and pain indices. METHODS: Patients with knee OA (n=105, with a mean age of 59.79±10.10 yrs and 50 sex and age-matched healthy controls were included in the study. Age, sex, symptom durations, body mass index (BMI and Kellgren-Lawrence scores were recorded. NHP was used in assessment of QoL in all patients and controls. Knee injury and Osteoarthritis Outcome Score (KOOS was used in assessment of disability and pain was assessed by using Visual Analog Scale (VAS in patients. RESULTS: Patients with knee OA had higher scores in all subgroups of NHP than controls. In patients the NHP total score significantly correlated to presence of effusion, VAS pain and the KOOS subgroups scores. DISCUSSION AND CONCLUSION: The patients with knee OA had a significantly poorer quality of life compared to the healthy persons. Besides, NHP was found to be associated with clinical examination findings and disability. We assume that NHP can effectively be used in evaluation of health status in patients with knee OA.

  12. Use of Condition-Specific Patient-Reported Outcome Measures in Clinical Trials among Patients with Wrist Osteoarthritis: A Systematic Review

    Directory of Open Access Journals (Sweden)

    Steven M. McPhail

    2012-01-01

    Full Text Available Background. This paper aimed to identify condition-specific patient-reported outcome measures used in clinical trials among people with wrist osteoarthritis and summarise empirical peer-reviewed evidence supporting their reliability, validity, and responsiveness to change. Methods. A systematic review of randomised controlled trials among people with wrist osteoarthritis was undertaken. Studies reporting reliability, validity, or responsiveness were identified using a systematic reverse citation trail audit procedure. Psychometric properties of the instruments were examined against predefined criteria and summarised. Results. Thirteen clinical trials met inclusion criteria. The most common patient-reported outcome was the disabilities of the arm, shoulder, and hand questionnaire (DASH. The DASH, the Michigan Hand Outcomes Questionnaire (MHQ, the Patient Evaluation Measure (PEM, and the Patient-Reported Wrist Evaluation (PRWE had evidence supporting their reliability, validity, and responsiveness. A post-hoc review of excluded studies revealed the AUSCAN Osteoarthritis Hand Index as another suitable instrument that had favourable reliability, validity, and responsiveness. Conclusions. The DASH, MHQ, and AUSCAN Osteoarthritis Hand Index instruments were supported by the most favourable empirical evidence for validity, reliability, and responsiveness. The PEM and PRWE also had favourable empirical evidence reported for these elements. Further psychometric testing of these instruments among people with wrist osteoarthritis is warranted.

  13. Measuring and Facilitating Client Engagement with Financial Incentives: Implications for Improving Clinical Outcomes in a Mental Health Setting.

    Science.gov (United States)

    Kotwicki, Raymond J; Balzer, Alexandra M; Harvey, Philip D

    2016-09-26

    Significant numbers of individuals with severe mental illnesses are difficult to engage in treatment services, presenting challenges for care. To be able to assess the relationship between engagement and discharge outcomes, we modified the "Milestones of Recovery Scale". This scale was modified for content to match the current clinical setting, evaluated for inter-rater reliability after modification in a sample of 233 cases receiving psychiatric rehabilitation, and then was administered to 423 additional psychiatric rehabilitation clients over a 24-month study period. In an effort to determine whether provision of financial incentives lead to sustained increases in client engagement, a cut off for client eligibility for financial incentives was evaluated on the basis of the reliability study and the course of engagement was related to receipt of this incentive and successful completion of treatment in a new sample of 423 patients. Of this sample, 78 % received an initial financial incentive during treatment (were initially engaged), and 93.3 % of that subgroup sustained this level of engagement it over their entire course of treatment. Of the 22 % of cases not receiving an initial incentive, only 5.4 % improved in their engagement to levels required for the incentive. Longitudinal analysis demonstrated that individuals who maintained or increased their level of engagement over time were more likely to complete treatment in accordance with planned treatment goals. The initial engagement and the course of engagement in treatment predicted successful completion, but incentives did not lead to increased engagement in initially poorly engaged patients. These data are interpreted in terms of the likely success of extrinsic rewards to increase engagement in mental health services.

  14. [Measuring outcome in spasticity rehabilitation].

    Science.gov (United States)

    Fheodoroff, K; Wissel, J; Entner, T; Freimüller, M

    2001-01-01

    Spasticity is a frequent consequence of upper motor neuron lesion and is associated with a variety of symptoms such as pain, muscle stiffness and reflex patterns that interfere with activities of daily living, dexterity and gait. As therapy strategies in managing spasticity-associated problems have been evolving there is an increasing need for a practicable documentation system which describes spasticity and related symptoms on different levels in order to evaluate especially the level of functioning. In daily routine the single-case-design reflects a useful technique to evaluate the status in terms of technical, functional and individual goals for treatment. However, there is no single tool to measure the different types of changes due to treatment, therefore a variety of selecting tests, based on the functional changes expected from the selected treatment, is recommended. The sensitivity of the selected tests should match the range of expected improvements related to the specific treatment. Technical goals should be evaluated by validated spasticity rating scales. As changes in technical measures of spasticity such as muscle tone, muscle length, range of motion or repetitive voluntary movements may not correlate with clinical improvements, individual functional goals should be defined. Those functional goals should reflect the patients' and care-givers' individual perception of the actual problem. A treatment diary is a useful tool to document subjective perception of changes over time. Some practical issues are adressed below. Reliable outcome measures enable patients and doctors to select further treatment strategies and gives health care providers information on treatment expectations in return for their investments.

  15. Measuring surgical outcomes in cervical spondylotic myelopathy patients undergoing anterior cervical discectomy and fusion: assessment of minimum clinically important difference.

    Directory of Open Access Journals (Sweden)

    Brenda M Auffinger

    Full Text Available OBJECT: The concept of minimum clinically important difference (MCID has been used to measure the threshold by which the effect of a specific treatment can be considered clinically meaningful. MCID has previously been studied in surgical patients, however few studies have assessed its role in spinal surgery. The goal of this study was to assess the role of MCID in patients undergoing anterior cervical discectomy and fusion (ACDF for cervical spondylotic myelopathy (CSM. METHODS: Data was collected on 30 patients who underwent ACDF for CSM between 2007 and 2012. Preoperative and 1-year postoperative Neck Disability Index (NDI, Visual-Analog Scale (VAS, and Short Form-36 (SF-36 Physical (PCS and Mental (MCS Component Summary PRO scores were collected. Five distribution- and anchor-based approaches were used to calculate MCID threshold values average change, change difference, receiver operating characteristic curve (ROC, minimum detectable change (MDC and standard error of measurement (SEM. The Health Transition Item of the SF-36 (HTI was used as an external anchor. RESULTS: Patients had a significant improvement in all mean physical PRO scores postoperatively (p<0.01 NDI (29.24 to 14.82, VAS (5.06 to 1.72, and PCS (36.98 to 44.22. The five MCID approaches yielded a range of values for each PRO: 2.00-8.78 for PCS, 2.06-5.73 for MCS, 4.83-13.39 for NDI, and 0.36-3.11 for VAS. PCS was the most representative PRO measure, presenting the greatest area under the ROC curve (0.94. MDC values were not affected by the choice of anchor and their threshold of improvement was statistically greater than the chance of error from unimproved patients. CONCLUSION: SF-36 PCS was the most representative PRO measure. MDC appears to be the most appropriate MCID method. When MDC was applied together with HTI anchor, the MCID thresholds were: 13.39 for NDI, 3.11 for VAS, 5.56 for PCS and 5.73 for MCS.

  16. Modulation of motor cortex excitability in obsessive-compulsive disorder: an exploratory study on the relations of neurophysiology measures with clinical outcome.

    Science.gov (United States)

    Mantovani, Antonio; Rossi, Simone; Bassi, Bruce D; Simpson, Helen B; Fallon, Brian A; Lisanby, Sarah H

    2013-12-30

    Low-frequency repetitive transcranial magnetic stimulation (rTMS) to supplementary motor area (SMA) showed clinical benefit in obsessive-compulsive disorder (OCD). Here we tested whether clinical improvement was associated with enhanced cortical inhibition as measured by single and paired-pulse TMS variables. In 18 OCD patients receiving 4 weeks of either active or sham rTMS in a double-blind randomized trial, we assessed bilateral resting and active motor thresholds (RMT and AMT), cortical silent period (CSP), short-interval intracortical inhibition (SICI) and intracortical facilitation (ICF). We tested correlations between changes in Yale-Brown Obsessive Compulsive Scale-Self-report (Y-BOCS-SR), Clinical Global Impression-Severity subscale (CGI-S) and cortical excitability measures. Active rTMS increased right hemisphere RMT whose change correlated with Y-BOCS-SR improvement. Baseline RMT hemispheric asymmetry, defined as the difference between left and right hemispheres RMT, and its normalization after active rTMS correlated with Y-BOCS-SR and CGI-S improvements. Active rTMS also increased right hemisphere SICI whose change correlated with Y-BOCS-SR and CGI-S at week 4, and with normalization of baseline RMT hemispheric asymmetry. Treatment-induced changes in cortical excitability measures are consistent with an inhibitory action of SMA rTMS on dysfunctional motor circuits in OCD. Correlations of neurophysiology measures with therapeutic outcome are supportive of the role of SMA in the modulation of OCD symptoms.

  17. Measuring Sperm DNA Fragmentation and Clinical Outcomes of Medically Assisted Reproduction: A Systematic Review and Meta-Analysis.

    Science.gov (United States)

    Cissen, Maartje; Wely, Madelon van; Scholten, Irma; Mansell, Steven; Bruin, Jan Peter de; Mol, Ben Willem; Braat, Didi; Repping, Sjoerd; Hamer, Geert

    2016-01-01

    Sperm DNA fragmentation has been associated with reduced fertilization rates, embryo quality, pregnancy rates and increased miscarriage rates. Various methods exist to test sperm DNA fragmentation such as the sperm chromatin structure assay (SCSA), the sperm chromatin dispersion (SCD) test, the terminal deoxynucleotidyl transferase mediated deoxyuridine triphosphate nick end labelling (TUNEL) assay and the single cell gel electrophoresis (Comet) assay. We performed a systematic review and meta-analysis to assess the value of measuring sperm DNA fragmentation in predicting chance of ongoing pregnancy with IVF or ICSI. Out of 658 unique studies, 30 had extractable data and were thus included in the meta-analysis. Overall, the sperm DNA fragmentation tests had a reasonable to good sensitivity. A wide variety of other factors may also affect the IVF/ICSI outcome, reflected by limited to very low specificity. The constructed hierarchical summary receiver operating characteristic (HSROC) curve indicated a fair discriminatory capacity of the TUNEL assay (area under the curve (AUC) of 0.71; 95% CI 0.66 to 0.74) and Comet assay (AUC of 0.73; 95% CI 0.19 to 0.97). The SCSA and the SCD test had poor predictive capacity. Importantly, for the TUNEL assay, SCD test and Comet assay, meta-regression showed no differences in predictive value between IVF and ICSI. For the SCSA meta-regression indicated the predictive values for IVF and ICSI were different. The present review suggests that current sperm DNA fragmentation tests have limited capacity to predict the chance of pregnancy in the context of MAR. Furthermore, sperm DNA fragmentation tests have little or no difference in predictive value between IVF and ICSI. At this moment, there is insufficient evidence to recommend the routine use of sperm DNA fragmentation tests in couples undergoing MAR both for the prediction of pregnancy and for the choice of treatment. Given the significant limitations of the evidence and the

  18. Triplex DNA-binding proteins are associated with clinical outcomes revealed by proteomic measurements in patients with colorectal cancer

    Directory of Open Access Journals (Sweden)

    Nelson Laura D

    2012-06-01

    Full Text Available Abstract Background Tri- and tetra-nucleotide repeats in mammalian genomes can induce formation of alternative non-B DNA structures such as triplexes and guanine (G-quadruplexes. These structures can induce mutagenesis, chromosomal translocations and genomic instability. We wanted to determine if proteins that bind triplex DNA structures are quantitatively or qualitatively different between colorectal tumor and adjacent normal tissue and if this binding activity correlates with patient clinical characteristics. Methods Extracts from 63 human colorectal tumor and adjacent normal tissues were examined by gel shifts (EMSA for triplex DNA-binding proteins, which were correlated with clinicopathological tumor characteristics using the Mann-Whitney U, Spearman’s rho, Kaplan-Meier and Mantel-Cox log-rank tests. Biotinylated triplex DNA and streptavidin agarose affinity binding were used to purify triplex-binding proteins in RKO cells. Western blotting and reverse-phase protein array were used to measure protein expression in tissue extracts. Results Increased triplex DNA-binding activity in tumor extracts correlated significantly with lymphatic disease, metastasis, and reduced overall survival. We identified three multifunctional splicing factors with biotinylated triplex DNA affinity: U2AF65 in cytoplasmic extracts, and PSF and p54nrb in nuclear extracts. Super-shift EMSA with anti-U2AF65 antibodies produced a shifted band of the major EMSA H3 complex, identifying U2AF65 as the protein present in the major EMSA band. U2AF65 expression correlated significantly with EMSA H3 values in all extracts and was higher in extracts from Stage III/IV vs. Stage I/II colon tumors (p = 0.024. EMSA H3 values and U2AF65 expression also correlated significantly with GSK3 beta, beta-catenin, and NF- B p65 expression, whereas p54nrb and PSF expression correlated with c-Myc, cyclin D1, and CDK4. EMSA values and expression of all three splicing factors correlated

  19. Capturing Patient-Reported Outcome (PRO) Data Electronically: The Past, Present, and Promise of ePRO Measurement in Clinical Trials.

    Science.gov (United States)

    Coons, Stephen Joel; Eremenco, Sonya; Lundy, J Jason; O'Donohoe, Paul; O'Gorman, Hannah; Malizia, William

    2015-08-01

    Patient-reported outcomes (PROs) are an important means of evaluating the treatment benefit of new medical products. It is recognized that PRO measures should be used when assessing concepts best known by the patient or best measured from the patient's perspective. As a result, there is growing emphasis on well defined and reliable PRO measures. In addition, advances in technology have significantly increased electronic PRO (ePRO) data collection capabilities and options in clinical trials. The movement from paper-based to ePRO data capture has enhanced the integrity and accuracy of clinical trial data and is encouraged by regulators. A primary distinction in the types of ePRO platforms is between telephone-based interactive voice response systems and screen-based systems. Handheld touchscreen-based devices have become the mainstay for remote (i.e., off-site, unsupervised) PRO data collection in clinical trials. The conventional approach is to provide study subjects with a handheld device with a device-based proprietary software program. However, an emerging alternative for clinical trials is called bring your own device (BYOD). Leveraging study subjects' own Internet-enabled mobile devices for remote PRO data collection (via a downloadable app or a Web-based data collection portal) has become possible due to the widespread use of personal smartphones and tablets. However, there are a number of scientific and operational issues that must be addressed before BYOD can be routinely considered as a practical alternative to conventional ePRO data collection methods. Nevertheless, the future for ePRO data collection is bright and the promise of BYOD opens a new chapter in its evolution.

  20. Report from the fourth international consensus meeting to harmonize core outcome measures for atopic eczema/dermatitis clinical trials (HOME initiative)

    NARCIS (Netherlands)

    Chalmers, J. R.; Simpson, E.; Apfelbacher, C. J.; Thomas, K. S.; von Kobyletzki, L.; Schmitt, J.; Singh, J. A.; Svensson, A.; Williams, H. C.; Abuabara, K.; Aoki, V.; Ardeleanu, M.; Awici-Rasmussen, M.; Barbarot, S.; Berents, T. L.; Block, J.; Bragg, A.; Burton, T.; Clemmensen, K. K. Bjerring; Creswell-Melville, A.; Dinesen, M.; Drucker, A.; Eckert, L.; Flohr, C.; Garg, M.; Gerbens, L. A. A.; Graff, A. L. B.; Hanifin, J.; Heinl, D.; Humphreys, R.; Ishii, H. A.; Kataoka, Y.; Leshem, Y. A.; Marquort, B.; Massuel, M. -A.; Merhand, S.; Mizutani, H.; Murota, H.; Murrell, D. F.; Nakahara, T.; Nasr, I.; Nograles, K.; Ohya, Y.; Osterloh, I.; Pander, Jan; Prinsen, C.; Purkins, L.; Ridd, M.; Sach, T.; Schuttelaar, M. -L. A.; Shindo, S.; Smirnova, J.; Sulzer, A.; Gjerde, E. Synnove; Takaoka, R.; Talmo, H. Vestby; Tauber, M.; Torchet, F.; Volke, A.; Wahlgren, C. -F.; Weidinger, S.; Weisshaar, E.; Wollenberg, A.; Yamaga, K.; Zhao, C. Y.; Spuls, P. I.

    2016-01-01

    This article is a report of the fourth meeting of the Harmonising Outcome Measures for Eczema (HOME) initiative held in Malmo, Sweden on 23-24 April 2015 (HOME IV). The aim of the meeting was to achieve consensus over the preferred outcome instruments for measuring patient-reported symptoms and qual

  1. Is Real-Time Feedback of Burn-Specific Patient-Reported Outcome Measures in Clinical Settings Practical and Useful? A Pilot Study Implementing the Young Adult Burn Outcome Questionnaire.

    Science.gov (United States)

    Ryan, Colleen M; Lee, Austin F; Kazis, Lewis E; Shapiro, Gabriel D; Schneider, Jeffrey C; Goverman, Jeremy; Fagan, Shawn P; Wang, Chao; Kim, Julia; Sheridan, Robert L; Tompkins, Ronald G

    2016-01-01

    Long-term follow-up care of survivors after burn injuries can potentially be improved by the application of patient-reported outcome measures (PROMs). PROMs can inform clinical decision-making and foster communication between the patient and provider. There are no previous reports using real-time, burn-specific PROMs in clinical practice to track and benchmark burn recovery over time. This study examines the feasibility of a computerized, burn-specific PROM, the Young Adult Burn Outcome Questionnaire (YABOQ), with real-time benchmarking feedback in a burn outpatient practice. The YABOQ was redesigned for formatting and presentation purposes using images and transcribed to a computerized format. The redesigned questionnaire was administered to young adult burn survivors (ages 19-30 years, 1-24 months from injury) via an ipad platform in the office before outpatient visits. A report including recovery curves benchmarked to a nonburned relatively healthy age-matched population and to patients with similar injuries was produced for the domains of physical function and social function limited by appearance. A copy of the domain reports as well as a complete copy of the patient's responses to all domain questions was provided for use during the clinical visit. Patients and clinicians completed satisfaction surveys at the conclusion of the visit. Free-text responses, included in the satisfaction surveys, were treated as qualitative data adding contextual information about the assessment of feasibility. Eleven patients and their providers completed the study for 12 clinical visits. All patients found the ipad survey and report "easy" or "very easy" to use. In nine instances, patients "agreed" or "strongly agreed" that it helped them communicate their situation to their doctor/nurse practitioner. Patients "agreed" or "strongly agreed" that the report helped them understand their course of recovery in 10 visits. In 11 visits, the patients "agreed" or "strongly agreed" that

  2. Measuring the extent of total thyroidectomy for differentiated thyroid carcinoma using radioactive iodine imaging: relationship with serum thyroglobulin and clinical outcomes.

    Science.gov (United States)

    Holsinger, F Christopher; Ramaswamy, Uma; Cabanillas, Maria E; Lang, Juntian; Lin, Heather Y; Busaidy, Naifa L; Grubbs, Elizabeth; Rahim, Sania; Sturgis, Erich M; Lee, Jeffrey E; Weber, Randal S; Clayman, Gary L; Rohren, Eric M

    2014-05-01

    IMPORTANCE Despite performing total thyroidectomy (TT), postoperative radioactive iodine (RAI) imaging often demonstrates the presence of residual thyroid tissue within the operative bed. OBJECTIVE To measure the extent of TT using postoperative RAI imaging and assessing serum thyroglobulin (Tg) level for patients with differentiated thyroid carcinoma (DTC). DESIGN, SETTING, AND PARTICIPANTS We evaluated 245 patients undergoing TT for clinically staged cT1-3N0M0 DTC, who underwent diagnostic postoperative RAI imaging. INTERVENTIONS Total thyroidectomy. MAIN OUTCOMES AND MEASURES On the basis of quantitative measurements, RAI uptake (RAIU) in the thyroid bed of 0.2% of administered activity was selected as the cutpoint to determine the presence or absence of thyroid remnant. RESULTS By postoperative RAI imaging, TT in 106 patients (43%) resulted in RAIU of less than 0.2%. In the remaining 139 patients (57%), there was measurable iodine-avid thyroid tissue and/or tumor in the thyroid bed (n = 117 [84%]), the neck (n = 4 [3%]), or both (n = 18 [13%]). For the entire study population, mean 24-hour RAIU was 0.62%. Stimulated serum Tg levels were obtained in 232 of 245 patients (95%). Measurable stimulated Tg level (≥1 ng/mL) (to convert to micrograms per liter, multiply by 1) was found in 26 of 102 patients (25%) without thyroid remnant and in 87of 133 patients (65%) with thyroid remnant (P < .001). CONCLUSIONS AND RELEVANCE A goal of postthyroidectomy RAIU of less than 0.2% helps maximize the likelihood of an unmeasurable postoperative Tg level, potentially simplifying follow-up evaluation and reducing the use of postoperative RAI in order to facilitate surveillance.

  3. Patient-reported outcome measures for asthma : a systematic review

    NARCIS (Netherlands)

    Worth, Allison; Hammersley, Victoria; Knibb, Rebecca; Flokstra-de-Blok, Bertine; DunnGalvin, Audrey; Walker, Samantha; Dubois, Anthony EJ; Sheikh, Aziz

    2014-01-01

    BACKGROUND: Patient-reported outcome measures (PROMs) are measures of the outcome of treatment(s) reported directly by the patient or carer. There is increasing international policy interest in using these to assess the impact of clinical care. AIMS: To identify suitably validated PROMs for asthma a

  4. Feasibility test of a UK-scalable electronic system for regular collection of patient-reported outcome measures and linkage with clinical cancer registry data: The electronic Patient-reported Outcomes from Cancer Survivors (ePOCS system

    Directory of Open Access Journals (Sweden)

    Velikova Galina

    2011-10-01

    Full Text Available Abstract Background Cancer survivors can face significant physical and psychosocial challenges; there is a need to identify and predict which survivors experience what sorts of difficulties. As highlighted in the UK National Cancer Survivorship Initiative, routine post-diagnostic collection of patient reported outcome measures (PROMs is required; to be most informative, PROMs must be linked and analysed with patients' diagnostic and treatment information. We have designed and built a potentially cost-efficient UK-scalable electronic system for collecting PROMs via the internet, at regular post-diagnostic time-points, for linking these data with patients' clinical data in cancer registries, and for electronically managing the associated patient monitoring and communications; the electronic Patient-reported Outcomes from Cancer Survivors (ePOCS system. This study aims to test the feasibility of the ePOCS system, by running it for 2 years in two Yorkshire NHS Trusts, and using the Northern and Yorkshire Cancer Registry and Information Service. Methods/Design Non-metastatic breast, colorectal and prostate cancer patients (largest survivor groups, within 6 months post-diagnosis, will be recruited from hospitals in the Yorkshire Cancer Network. Participants will be asked to complete PROMS, assessing a range of health-related quality-of-life outcomes, at three time-points up to 15 months post-diagnosis, and subsequently to provide opinion on the ePOCS system via a feedback questionnaire. Feasibility will be examined primarily in terms of patient recruitment and retention rates, the representativeness of participating patients, the quantity and quality of collected PROMs data, patients' feedback, the success and reliability of the underpinning informatics, and the system running costs. If sufficient data are generated during system testing, these will be analysed to assess the health-related quality-of-life outcomes reported by patients, and to explore

  5. Interpreting the clinical importance of treatment outcomes in chronic pain clinical trials: IMMPACT recommendations

    DEFF Research Database (Denmark)

    Dworkin, R.H.; Turk, D.C.; Wyrwich, K.W.;

    2008-01-01

    . Provisional benchmarks for identifying clinically important changes in specific outcome measures that can be used for outcome studies of treatments for chronic pain are proposed. PERSPECTIVE: Systematically collecting and reporting the recommended information needed to evaluate the clinical importance......A consensus meeting was convened by the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT) to provide recommendations for interpreting clinical importance of treatment outcomes in clinical trials of the efficacy and effectiveness of chronic pain treatments. A group...... of 40 participants from universities, governmental agencies, a patient self-help organization, and the pharmaceutical industry considered methodologic issues and research results relevant to determining the clinical importance of changes in the specific outcome measures previously recommended by IMMPACT...

  6. Liposomal bupivacaine and clinical outcomes.

    Science.gov (United States)

    Tong, Yi Cai Isaac; Kaye, Alan David; Urman, Richard D

    2014-03-01

    In the multimodal approach to the management of postoperative pain, local infiltration and regional blocks have been increasingly utilized for pain control. One of the limitations of local anesthetics in the postoperative setting is its relatively short duration of action. Multivesicular liposomes containing bupivacaine have been increasingly utilized for their increased duration of action. Compared with bupivacaine HCl, local infiltration of liposomal bupivacaine has shown to have an increase in duration of action and causes delay in peak plasma concentration. In this article, we attempt to review the clinical literature surrounding liposomal bupivacaine and its evolving role in perioperative analgesia. This new bupivacaine formation may have promising implications in postoperative pain control, resulting in increased patient satisfaction and a decrease in both hospital stay and opioid-induced adverse events (AEs). Although more studies are needed, the preliminary clinical trials suggest that liposomal bupivacaine has predictable pharmacokinetics, a similar side effect profile compared with bupivacaine HCl, and is effective in providing increased postoperative pain control.

  7. Clinical outcomes assessment in clinical trials to assess treatment of femoroacetabular impingement

    DEFF Research Database (Denmark)

    Harris-Hayes, Marcie; McDonough, Christine M; Leunig, Michael

    2013-01-01

    Patient-reported outcome measures are an important component of outcomes assessment in clinical trials to assess the treatment of femoroacetabular impingement (FAI). This review of disease-specific measures and instruments used to assess the generic quality of life and physical activity levels...

  8. [Patient-reported outcomes: definition and measurement].

    Science.gov (United States)

    Botturi, Davide; Rodella, Stefania

    2014-06-01

    The concept of "patient-reported outcomes" have been proposed by the Food and Drug Administration in the year 2000, in order to describe one of the different and potential sources of information on the drug's safety and effectiveness. It represents an "umbrella" term, which covers a multiplicity of meanings and primarily identifies a conceptual approach and a methodology specifically oriented to the patients' point of view on outcomes, instead of the traditional clinical and professional perspective. The patient-reported outcomes measures are frequently self-completed questionnaires. The measures can be classified in general and specific. The first one, general, relates to the assessment of the quality of life or the health status, in the general population or in subgroups with particular health problems (eg. SF-36 Health Survey, EQ-5D). The second one, specific, mainly relates to the assessment of particular types of symptoms (eg. pain, anxiety, fear, depression) and functions (eg. daily living activities), in population's subgroups with definite health problems, undergoing or not to a healthcare procedure (eg. Adult Asthma Quality of Life Questionnaire, Kidney Disease Quality of Life Instrument, Oxford Hip Score, Oxford Knee Score). For the selection of an instrument a series of criteria needs to be taken into account, among which the psychometric properties, the expert judgement, the interpretability, the acceptability, and the feasibility of the entire process.

  9. Predicting Clinical Outcomes Using Molecular Biomarkers.

    Science.gov (United States)

    Burke, Harry B

    2016-01-01

    Over the past 20 years, there has been an exponential increase in the number of biomarkers. At the last count, there were 768,259 papers indexed in PubMed.gov directly related to biomarkers. Although many of these papers claim to report clinically useful molecular biomarkers, embarrassingly few are currently in clinical use. It is suggested that a failure to properly understand, clinically assess, and utilize molecular biomarkers has prevented their widespread adoption in treatment, in comparative benefit analyses, and their integration into individualized patient outcome predictions for clinical decision-making and therapy. A straightforward, general approach to understanding how to predict clinical outcomes using risk, diagnostic, and prognostic molecular biomarkers is presented. In the future, molecular biomarkers will drive advances in risk, diagnosis, and prognosis, they will be the targets of powerful molecular therapies, and they will individualize and optimize therapy. Furthermore, clinical predictions based on molecular biomarkers will be displayed on the clinician's screen during the physician-patient interaction, they will be an integral part of physician-patient-shared decision-making, and they will improve clinical care and patient outcomes.

  10. Clinical outcomes of combined flow-pressure drop measurements using newly developed diagnostic endpoint:Pressure drop coefficient in patients with coronary artery dysfunction

    Institute of Scientific and Technical Information of China (English)

    Mohamed A Effat; Srikara Viswanath Peelukhana; Rupak K Banerjee

    2016-01-01

    AIM:To combine pressure and flow parameter, pressure drop coefficient(CDP) will result in better clinical outcomes in comparison to the fractional flow reserve(FFR) group. METHODS:To test this hypothesis, a comparison was made between the FFR 27.9 groups in this study, for the major adverse cardiac events [major adverse cardiac events(MACE): Primary outcome] and patients’ quality of life(secondary outcome). Further, a comparison was also made between the survival curves for the FFR 27.9 groups. Two-tailed χ~2 test proportions were performed for the comparison of primary and secondary outcomes. Kaplan-Meier survival analysis was performed to compare the survival curves of FFR 27.9 groups(MedcalcV10.2, Mariakerke, Belgium). Results were considered statistically significant for P 27.9 group(8.57%, 2 out of 35). Noteworthy is the reduction in the %MACE in the CDP > 27.9 group, in comparison to the FFR 27.9 groups. Survival analysis results suggest that the survival time for the CDP > 27.9 group(n = 35) is significantly higher(P = 0.048) in comparison to the survival time for the FFR < 0.75 group(n = 20). The results remained similar for a FFR = 0.80 cut-off. CONCLUSION: Based on the above, CDP could prove to be a better diagnostic end-point for clinical revascularization decision-making in the cardiac catheterization laboratories.

  11. The reliability of British Sign Language and English versions of the Clinical Outcomes in Routine Evaluation--Outcome Measure with d/Deaf populations in the UK: an initial study.

    Science.gov (United States)

    Rogers, Katherine; Evans, Chris; Campbell, Malcolm; Young, Alys; Lovell, Karina

    2014-05-01

    Previous research has argued that the mental well-being of d/Deaf people is poorer than that of hearing populations. However, there is a paucity of valid and reliable mental health instruments in sign language that have been normalised with d/Deaf populations. The aim of this study was to determine the reliability of the Clinical Outcomes in Routine Evaluation - Outcome Measure (CORE-OM) with d/Deaf populations. A British Sign Language (BSL) version was produced using a team approach to forward translation, and a back-translation check. The CORE-OM was incorporated into an online survey, to be completed in either BSL or English, as preferred by the participant. From December 2010 to March 2011, data were collected from 136 d/Deaf people. Cronbach's α was used to measure the internal consistency of items in the CORE-OM. Comparisons were made between versions, including comparisons with the non-clinical hearing population (not in receipt of mental health services) in a previous study. The reliability of the overall score, as well as the non-risk items in both the BSL and English versions, was satisfactory. The internal reliability of each domain in the BSL version was good (Cronbach's α > 0.70) and comparable to the English version in the hearing population. This was true for most domains of the CORE-OM in the English version completed by d/Deaf people, although the Functioning domain had a relatively low α of 0.79 and the Risk domain had an α of only 0.66 This raised the question whether it is advisable to use a mental health assessment with d/Deaf populations that has been standardised with hearing populations. Nevertheless, this study has shown that it is possible to collect data from d/Deaf populations in the UK via the web (both in BSL and English), and an online BSL version of the CORE-OM is recommended for use with Deaf populations in the community.

  12. Clinical outcomes in clinical trials of anti-HIV treatment

    DEFF Research Database (Denmark)

    Reekie, J; Mocroft, A; J, Neaton;

    2007-01-01

    Since the introduction of combination antiretroviral therapy, there has been a decrease in both AIDS-defining illnesses and deaths. This decrease meant that performing clinical trials with clinical outcomes in HIV infection became more time consuming and hence costly. Improved understanding...

  13. Clinical outcomes in clinical trials of anti-HIV treatment

    DEFF Research Database (Denmark)

    Reekie, J; Mocroft, A; J, Neaton;

    2007-01-01

    Since the introduction of combination antiretroviral therapy, there has been a decrease in both AIDS-defining illnesses and deaths. This decrease meant that performing clinical trials with clinical outcomes in HIV infection became more time consuming and hence costly. Improved understanding and k...

  14. Assessing the Stroke-Specific Quality of Life for Outcome Measurement in Stroke Rehabilitation: Minimal Detectable Change and Clinically Important Difference

    Directory of Open Access Journals (Sweden)

    Wu Ching-yi

    2011-01-01

    Full Text Available Abstract Background This study was conducted to establish the minimal detectable change (MDC and clinically important differences (CIDs of the physical category of the Stroke-Specific Quality of Life Scale in patients with stroke. Methods MDC and CIDs scores were calculated from the data of 74 participants enrolled in randomized controlled trials investigating the effects of two rehabilitation programs in patients with stroke. These participants received treatments for 3 weeks and underwent clinical assessment before and after treatment. To obtain test-retest reliability for calculating MDC, another 25 patients with chronic stroke were recruited. The MDC was calculated from the standard error of measurement (SEM to indicate a real change with 95% confidence for individual patients (MDC95. Distribution-based and anchor-based methods were adopted to triangulate the ranges of minimal CIDs. The percentage of scale width was calculated by dividing the MDC and CIDs by the total score range of each physical category. The percentage of patients exceeding MDC95 and minimal CIDs was also reported. Results The MDC95 of the mobility, self-care, and upper extremity (UE function subscales were 5.9, 4.0, and 5.3 respectively. The minimal CID ranges for these 3 subscales were 1.5 to 2.4, 1.2 to 1.9, and 1.2 to 1.8. The percentage of patients exceeding MDC95 and minimal CIDs of the mobility, self-care, and UE function subscales were 9.5% to 28.4%, 6.8% to 28.4%, and 12.2% to 33.8%, respectively. Conclusions The change score of an individual patient has to reach 5.9, 4.0, and 5.3 on the 3 subscales to indicate a true change. The mean change scores of a group of patients with stroke on these subscales should reach the lower bound of CID ranges of 1.5 (6.3% scale width, 1.2 (6.0% scale width, and 1.2 (6.0% scale width to be regarded as clinically important change. This information may facilitate interpretations of patient-reported outcomes after stroke

  15. Clinical and radiological outcome after periacetabular osteotomy

    DEFF Research Database (Denmark)

    Dahl, Line B; Dengsø, Kristine; Bang-Christiansen, Karl;

    2014-01-01

    PURPOSE: Few papers have described results after periacetabular osteotomy (PAO) and risk factors for conversion to total hip arthroplasty (THA). The aim of the present paper was to analyse clinical and radiographic outcome, survival of the hip joint and risk factors of early conversion to THA in ...

  16. Biosimilars : linking quality data to clinical outcomes

    NARCIS (Netherlands)

    Halim, L.A.

    2016-01-01

    The aim of this study was to establish a link between quality attributes of biosimilars and potential clinical outcomes with regards to safety and immunogenicity. As we have access to multiple biosimilar and copy biologic products as well to patient data, the research involved linking comparative qu

  17. Effect size for dichotomous outcome measures

    Institute of Scientific and Technical Information of China (English)

    Yuanjia WANG; Naihua DUAN

    2011-01-01

    @@ Effect size for continuous outcome measures was discussed in our previous column[1].In this column we discuss several widely used effect size measures for dichotomous (Yes/No) outcome measures such as mortality,relapse,cure,discontinuation of treatment,and so forth.

  18. Comparison of self-reported and performance-based measures of functional ability in elderly patients in an emergency department: implications for selection of clinical outcome measures

    DEFF Research Database (Denmark)

    Nielsen, Louise Møldrup

    2016-01-01

    moderate (r = 0.53). The correlation between the Barthel-20 and the 30s-CST was fair (r = 0.45). The correlation between Barthel-20 and the AMPS process was non-significant. The results were affected by high ceiling effect (Barthel-20). Conclusion Self-reported and performance-based measures seem to assess......Background Assessment of functional ability in elderly patients is often based on self-reported rather than performance-based measures. This study aims to compare self-reported and performance-based measures of functional ability in a population of elderly patients at an emergency department (ED......). Methods Participants were 61 patients aged 65 years and above admitted to an ED. The self-reported measure used was the Barthel-20; the performance-based measures were Timed Up and Go (TUG); 30s-Chair Stand Test (30s-CST) and Assessment of Motor and Process Skills (AMPS) with the two scales; motor...

  19. The International Dermatology Outcome Measures initiative as applied to psoriatic disease outcomes

    DEFF Research Database (Denmark)

    Gottlieb, Alice B; Armstrong, April W; Christensen, Robin;

    2014-01-01

    In the United States, access to care is the number one issue facing our patients with dermatological conditions. In part, this is because we do not have outcome measures that are useful in clinical practice and available in databases where payers and governmental agencies can compare the performa......, payers, and pharmaceutical scientists. As reported herein, the group's goal is to develop outcome measures in dermatology that address the needs of all involved....

  20. Outcomes of a Nurse-Managed Diabetes Foot Clinic

    Science.gov (United States)

    2016-06-07

    Managed Diabetes Foot Clinic 5b. GRANT NUMBER HU0001-04-1-TS10 5c. PROGRAM ELEMENT NUMBER N/A 6. AUTHOR(S) 5d. PROJECT NUMBER N04-017...measured outcomes of a nurse-managed diabetes foot clinic on foot wound rates, health care costs, and changes in health status in adults with...assignment by risk. All received diabetic - foot self-care education and foot assessment. Controls were seen very three months. Treatment participants

  1. Knee Injury and Osteoarthritis Outcome Score (KOOS)--development of a self-administered outcome measure

    DEFF Research Database (Denmark)

    1998-01-01

    and recreation function, and knee-related quality of life. In this clinical study, the KOOS proved reliable, responsive to surgery and physical therapy, and valid for patients undergoing anterior cruciate ligament reconstruction. The KOOS meets basic criteria of outcome measures and can be used to evaluate......-term patient-relevant outcomes following knee injury, based on the WOMAC Osteoarthritis Index, a literature review, an expert panel, and a pilot study. The Knee injury and Osteoarthritis Outcome Score (KOOS) is self-administered and assesses five outcomes: pain, symptoms, activities of daily living, sport...

  2. Clinical Practice Variability in Temperature Correction of Arterial Blood Gas Measurements and Outcomes in Hypothermia-Treated Patients After Cardiac Arrest.

    Science.gov (United States)

    Terman, Samuel Waller; Nicholas, Katherine S; Hume, Benjamin; Silbergleit, Robert

    2015-09-01

    Mechanical ventilation in patients treated with mild therapeutic hypothermia (MTH) for the postcardiac arrest syndrome may be challenging given changes in solubility of arterial blood gases (ABGs) with cooling. Whether ABG measurements should be temperature corrected (TC) remain unknown. We sought to describe practice variability in TC at a single institution and explored the association between TC and neurological outcome. We conducted a retrospective cohort study reviewing electronic health records of all patients treated with MTH after cardiac arrest. We examined whether the percentage of TC ABGs relative to total number of ABGs drawn for each subject during hypothermia was associated with the neurological outcome at hospital discharge and 6-12-month follow-up. The cerebral performance category of 1-2 was defined as a favorable outcome in the logistic regression models. 1223 ABGs were obtained during MTH on 122 subjects over 6 years. TC was never used in 72 subjects (59%; no TC group), made available in 1-74% of ABGs in 17 subjects (14%; intermediate TC group), and made available in ≥75% of ABGs in 33 subjects (27%; mostly TC group). Groups differed in the proportion of subjects with shockable presenting rhythms (47% vs. 47% vs. 76%, p=0.02) and admitting ICU (p=0.005). Favorable 6-month outcomes were more common in the mostly TC than no TC group (48% vs. 25%; OR [95% CI]: 2.9 [1.2-7.1]), but not after adjustment (OR 1.5, 95% CI 0.33-6.9). There was substantial practice variability in the temperature correction strategy. Availability of temperature-corrected ABGs was not associated with improved neurological outcomes after adjusting for covariates.

  3. Clinical Outcomes Following Revision Anterior Shoulder Stabilization

    Science.gov (United States)

    Frank, Rachel M.; Mellano, Chris; Shin, Jason J.; Feldheim, Terrence F.; Mascarenhas, Randhir; Yanke, Adam Blair; Cole, Brian J.; Nicholson, Gregory P.; Romeo, Anthony A.; Verma, Nikhil N.

    2015-01-01

    Objectives: The purpose of this study was to determine the clinical outcomes following revision anterior shoulder stabilization performed either via all-arthroscopic soft tissue repair or via Latarjet coracoid transfer. Methods: A retrospective review of prospectively collected data on 91 shoulders undergoing revision anterior shoulder stabilization was performed. All patients underwent prior soft tissue stabilization; those with prior open bone grafting procedures were excluded. For patients with 25% glenoid bone loss, Latarjet was performed (n=28). Patients were queried regarding recurrent instability (subluxation or dislocation). Clinical outcomes were evaluated using validated patient reported outcome questionnaires including the American Shoulder and Elbow Surgeons (ASES) score, Simple Shoulder Test (SST), visual analog scale (VAS) for pain, and Western Ontario Shoulder Instability Index (WOSI). Results: A total of 63 shoulders in 62 patients (46 males, 16 females) with an average age of 23.2 ± 6.9 years were included in the revision arthroscopy group. At an average follow-up of 46.9 ± 16.8 months (range, 15 to 78), the mean WOSI score was 80.1 (range, 15.0 to 100), and there were significant improvements (pLatarjet group. Thirteen (46%) had more than one previous stabilization attempt. ), the average WOSI score was 71.9, and there were significant improvements (pLatarjet. Conclusion: Both arthroscopic revision stabilization and Latarjet coracoid transfer result in satisfactory outcomes in patients who have failed previous arthroscopic capsulolabral repair. Recurrent instability rates were higher in the all-arthroscopic group (19% versus 7%). Longer-term studies are required to determine whether similar results are maintained over time, and to provide guidance on focused clinical indications for this challenging patient population.

  4. Current status of outcome measure development in vasculitis.

    Science.gov (United States)

    Merkel, Peter A; Aydin, Sibel Z; Boers, Maarten; Cornell, Christina; Direskeneli, Haner; Gebhart, Don; Hatemi, Gulen; Luqmani, Raashid; Matteson, Eric L; Milman, Nataliya; Robson, Joanna; Seo, Philip; Tomasson, Gunnar

    2014-03-01

    The conduct of randomized controlled trials for vasculitis, especially for the antineutrophil cytoplasmic antibody-associated vasculitides [AAV, granulomatosis with polyangiitis (Wegener's) and microscopic polyangiitis], has been greatly advanced by the development, use, and acceptance of validated outcome measures. Trials have subsequently provided the opportunity to validate and refine reliable, valid outcome measures for these multisystemic and relapsing rare diseases. The Outcome Measures in Rheumatology (OMERACT) Vasculitis Working Group was formed in 2004 to foster development of validated and widely accepted outcomes in vasculitis using data-driven analyses, a dedication to building consensus, and adherence to, and guidance by, the principles of the OMERACT approach. This work led to the endorsement by OMERACT of the core set of domains and associated outcome measures for AAV. Next steps for the study of existing outcome tools in AAV include better definition of response criteria through development of more data-driven weighting of the elements of activity and damage assessment. The Working Group is now also embarking on a series of linked projects to develop validated patient-reported outcomes for use in clinical research in vasculitis. Additionally, the Working Group is studying how current methods of disease assessment and plans for new outcomes can be informed by the conceptual framework of the International Classification of Function of the World Health Organization. The success of the Group's work in AAV has also led to a formal process for developing outcomes for the large vessel vasculitides (Takayasu arteritis and giant cell arteritis) and Behçet disease.

  5. Relationship Between Patient-Reported Outcomes and Clinical Outcomes in Patients With Morquio A Syndrome

    Directory of Open Access Journals (Sweden)

    Christina Lampe MD

    2015-04-01

    Full Text Available This cross-sectional analysis assessed the correlation between patient-reported outcomes (PROs and clinical outcomes in 24 German patients with Morquio A. Clinical outcomes included 6-minute walk test (6MWT, 3-minute stair climb (3MSC test, and joint range of motion as measures for endurance/mobility, forced vital capacity (FVC and maximum voluntary ventilation (MVV as measures for respiratory function, and height as an important manifestation. The PROs included the EuroQoL (EQ 5D-5L (EQ5D-5L, to measure health-related QoL (HRQoL, and patients’ rating of their ability to walk, climb, or breathe. In adults, endurance and pulmonary function measures and height showed strong and statistically significant correlation with the patients’ EQ5D-5L (6MWT: R = .884, 3MSC test: R = .852, FVC: R = .815, MVV: R = .825, height: R = .842. The adult patients’ rating of their ability to walk and climb also correlated strongly with 6MWT (R = .839 and 3MSC test (R = .700 results. Improvements in these clinical outcomes may be robust surrogate parameters of a better EQ5D-5L/HRQoL in patients with Morquio A.

  6. Community-Based Health Education Programs Designed to Improve Clinical Measures Are Unlikely to Reduce Short-Term Costs or Utilization Without Additional Features Targeting These Outcomes.

    Science.gov (United States)

    Burton, Joe; Eggleston, Barry; Brenner, Jeffrey; Truchil, Aaron; Zulkiewicz, Brittany A; Lewis, Megan A

    2016-06-07

    Stakeholders often expect programs for persons with chronic conditions to "bend the cost curve." This study assessed whether a diabetes self-management education (DSME) program offered as part of a multicomponent initiative could affect emergency department (ED) visits, hospital stays, and the associated costs for an underserved population in addition to the clinical indicators that DSME programs attempt to improve. The program was implemented in Camden, New Jersey, by the Camden Coalition of Healthcare Providers to address disparities in diabetes care. Data used are from medical records and from patient-level information about hospital services from Camden's hospitals. Using multivariate regression models to control for individual characteristics, changes in utilization over time and changes relative to 2 comparison groups were assessed. No reductions in ED visits, inpatient stays, or costs for participants were found over time or relative to the comparison groups. High utilization rates and costs for diabetes are associated with longer term disease progression and its sequelae; thus, DSME or peer support may not affect these in the near term. Some clinical indicators improved among participants, and these might lead to fewer costly adverse health events in the future. DSME deployed at the community level, without explicit segmentation and targeting of high health care utilizers or without components designed to affect costs and utilization, should not be expected to reduce short-term medical needs for participating individuals or care-seeking behaviors such that utilization is reduced. Stakeholders must include financial outcomes in a program's design if those outcomes are to improve. (Population Health Management 20XX;XX:XXX-XXX).

  7. Observer bias in randomised clinical trials with binary outcomes

    DEFF Research Database (Denmark)

    Hróbjartsson, Asbjørn; Thomsen, Ann Sofia Skou; Emanuelsson, Frida;

    2012-01-01

    To evaluate the impact of non-blinded outcome assessment on estimated treatment effects in randomised clinical trials with binary outcomes.......To evaluate the impact of non-blinded outcome assessment on estimated treatment effects in randomised clinical trials with binary outcomes....

  8. Identifying meaningful outcome measures for the intensive care unit.

    Science.gov (United States)

    Martinez, Elizabeth A; Donelan, Karen; Henneman, Justin P; Berenholtz, Sean M; Miralles, Paola D; Krug, Allison E; Iezzoni, Lisa I; Charnin, Jonathan E; Pronovost, Peter J

    2014-01-01

    Despite important progress in measuring the safety of health care delivery in a variety of health care settings, a comprehensive set of metrics for benchmarking is still lacking, especially for patient outcomes. Even in high-risk settings where similar procedures are performed daily, such as hospital intensive care units (ICUs), these measures largely do not exist. Yet we cannot compare safety or quality across institutions or regions, nor can we track whether safety is improving over time. To a large extent, ICU outcome measures deemed valid, important, and preventable by clinicians are unavailable, and abstracting clinical data from the medical record is excessively burdensome. Even if a set of outcomes garnered consensus, ensuring adequate risk adjustment to facilitate fair comparisons across institutions presents another challenge. This study reports on a consensus process to build 5 outcome measures for broad use to evaluate the quality of ICU care and inform quality improvement efforts.

  9. Measuring behavioral outcomes in cardiopulmonary rehabilitation: AN AACVPR STATEMENT.

    Science.gov (United States)

    Verrill, David; Graham, Helen; Vitcenda, Mark; Peno-Green, Laura; Kramer, Valerie; Corbisiero, Teresa

    2009-01-01

    Outcome measurement in cardiopulmonary rehabilitation is required for optimal assessment of program quality, effectiveness of treatments, and evaluation of patient progress. Recent position statements from the American Association of Cardiovascular and Pulmonary Rehabilitation (AACVPR), American College of Cardiology, American Heart Association, American Thoracic Society, and American College of Chest Physicians have provided state-of-the-art information on the importance of assessing performance and outcome measures for optimal program effectiveness. Such measures are also required for AACVPR program certification. To meet current standards of practice, the AACVPR developed an Outcomes Matrix that includes 4 domains: Health, Clinical, Behavioral, and Service. Although the Clinical and Health domains have been most commonly used in outcome reporting (eg, 6-minute walk test, quality-of-life survey scores), behavioral measures have received less attention, primarily because they have been perceived as being more difficult to measure and quantify over time. This statement describes 5 common behavioral outcome measures: smoking cessation, medication use, supplemental oxygen use, exercise habits, and nutritional behaviors. Sample questions and calculations for each of these behavioral measures are also provided. By using these measures at program entry and completion, cardiac and pulmonary rehabilitation practitioners can effectively track and document behavioral changes over time for physicians, third-party insurance providers, or hospital administrators and thus demonstrate the effectiveness of exercise and educational interventions on patient overall health and well-being.

  10. Pyogenic sacroiliitis: diagnosis, management and clinical outcome

    Energy Technology Data Exchange (ETDEWEB)

    Kucera, Tomas; Sponer, Pavel [Charles University in Prague, Faculty of Medicine and University Hospital in Hradec Kralove, Department of Orthopaedic Surgery, Hradec Kralove (Czech Republic); Brtkova, Jindra [Charles University in Prague, Faculty of Medicine and University Hospital in Hradec Kralove, Department of Diagnostic Radiology, Hradec Kralove (Czech Republic); Ryskova, Lenka [Charles University in Prague, Faculty of Medicine and University Hospital in Hradec Kralove, Department of Clinical Microbiology, Hradec Kralove (Czech Republic); Popper, Eduard [Charles University in Prague, Faculty of Medicine and University Hospital in Hradec Kralove, Department of Rehabilitation, Hradec Kralove (Czech Republic); Frank, Martin [Charles University in Prague, Faculty of Medicine and University Hospital in Hradec Kralove, Department of Surgery, Hradec Kralove (Czech Republic); Kucerova, Marie [Regional Hospital in Pardubice, Department of Neurosurgery, Hradec Kralove (Czech Republic)

    2015-01-15

    The purpose of the present study was to evaluate the role of diagnostic tools and management options for patients with pyogenic sacroiliitis, including potential complications. This retrospective study included 16 patients with pyogenic sacroiliitis who were admitted to a single orthopaedic centre between 2007 and 2012. The following data were collected: demographics, history, radiography, magnetic resonance images (MRI), biological data, type of pathogenic agent, abscess formation, type of management, and clinical outcome. Our study demonstrated that only one-fifth of the patients with lumbogluteal or hip pain had established diagnoses of suspected pyogenic sacroiliitis upon admission. MRIs confirmed this diagnosis in all cases. MRI examinations revealed joint fluid in the sacroiliac joint and significant oedema of the adjacent bone and soft tissues. In 12 of the 16 cases, erosions of the subchondral bone were encountered. Contrast-enhanced MRI revealed that 9 patients had abscesses. All patients received antibiotic therapy. Antibiotic treatment was only successful in 9 cases. The other 7 patients underwent computed tomography (CT)-guided abscess drainage. Drainage was sufficient for 4 patients, but 3 patients required open surgery. One patient required sacroiliac arthrodesis. The clinical outcomes included minimal disability (n = 10), moderate disability (n = 5), and full disability (n = 1) of the spine. Contrast-enhanced MRI is mandatory for a reliable diagnosis. Abscess formation was observed in approximately half of the MRI-diagnosed sacroiliitis cases and required minimally invasive drainage under CT guidance or frequently open surgery. (orig.)

  11. Toward a Global Consensus on Outcome Measures for Clinical Trials in Tinnitus: Report From the First International Meeting of the COMiT Initiative, November 14, 2014, Amsterdam, The Netherlands

    Directory of Open Access Journals (Sweden)

    Deborah A. Hall

    2015-04-01

    Full Text Available In Europe alone, over 70 million people experience tinnitus; for seven million people, it creates a debilitating condition. Despite its enormous socioeconomic relevance, progress in successfully treating the condition is somewhat limited. The European Union has approved funding to create a pan-European tinnitus research collaboration network (2014–2018. The goal of one working group is to establish an international standard for outcome measurements in clinical trials of tinnitus. Importantly, this would enhance tinnitus research by informing sample-size calculations, enabling meta-analyses, and facilitating the identification of tinnitus subtypes, ultimately leading to improved treatments. The first meeting followed a workshop on “Agreed Standards for Measurement: An International Perspective” with invited talks on clinimetrics and existing international initiatives to define core sets for outcome measurements in hearing loss (International classification of functioning, disability, and health core sets for hearing loss and eczema (Harmonizing outcome measures for eczema. Both initiatives have taken an approach that clearly distinguishes the specification of what to measure from that of how to measure it. Meeting delegates agreed on taking a step-wise roadmap for which the first output would be a consensus on what outcome domains are essential for all trials. The working group seeks to embrace inclusivity and brings together clinicians, tinnitus researchers, experts on clinical research methodology, statisticians, and representatives of the health industry. People who experience tinnitus are another important participant group. This meeting report is a call to those stakeholders across the globe to actively participate in the initiative.

  12. Are Problems Prevalent and Stable in Non-Clinical Populations? Problems and Test-Retest Stability of a Patient-Generated Measure, PSYCHLOPS (Psychological Outcome Profiles), in a Non-Clinical Student Sample

    Science.gov (United States)

    Evans, Chris; Ashworth, Mark; Peters, Marilyn

    2010-01-01

    In straightened times counselling must evidence the changes it promotes on reputable measures. Patient-generated measures complement nomothetic measures and may be nearer the ethos of counselling in eliciting individuals' problems. Scores from such measures from non-clinical samples are rarely reported, making their test-retest stability…

  13. Quality Markers in Cardiology. Main Markers to Measure Quality of Results (Outcomes) and Quality Measures Related to Better Results in Clinical Practice (Performance Metrics). INCARDIO (Indicadores de Calidad en Unidades Asistenciales del Área del Corazón): A SEC/SECTCV Consensus Position Paper.

    Science.gov (United States)

    López-Sendón, José; González-Juanatey, José Ramón; Pinto, Fausto; Cuenca Castillo, José; Badimón, Lina; Dalmau, Regina; González Torrecilla, Esteban; López-Mínguez, José Ramón; Maceira, Alicia M; Pascual-Figal, Domingo; Pomar Moya-Prats, José Luis; Sionis, Alessandro; Zamorano, José Luis

    2015-11-01

    Cardiology practice requires complex organization that impacts overall outcomes and may differ substantially among hospitals and communities. The aim of this consensus document is to define quality markers in cardiology, including markers to measure the quality of results (outcomes metrics) and quality measures related to better results in clinical practice (performance metrics). The document is mainly intended for the Spanish health care system and may serve as a basis for similar documents in other countries.

  14. Multiple sclerosis: integration of modeling with biology, clinical and imaging measures to provide better monitoring of disease progression and prediction of outcome.

    Science.gov (United States)

    Goodwin, Shikha Jain

    2016-12-01

    Multiple Sclerosis (MS) is a major cause of neurological disability in adults and has an annual cost of approximately $28 billion in the United States. MS is a very complex disorder as demyelination can happen in a variety of locations throughout the brain; therefore, this disease is never the same in two patients making it very hard to predict disease progression. A modeling approach which combines clinical, biological and imaging measures to help treat and fight this disorder is needed. In this paper, I will outline MS as a very heterogeneous disorder, review some potential solutions from the literature, demonstrate the need for a biomarker and will discuss how computational modeling combined with biological, clinical and imaging data can help link disparate observations and decipher complex mechanisms whose solutions are not amenable to simple reductionism.

  15. Measuring Learning Outcomes in Auditing Education

    DEFF Research Database (Denmark)

    Holm, Claus; Steenholdt, Niels

    The ability to provide sensible measures for learning outcomes in accounting education is under increased scrutiny. In this paper we use a learner perspective in auditing education, which reflects that some students taking accounting classes also are provided with on-the-job training in accounting...... firms. Hence knowledge about learning outcomes for different groups of students is essential information for educators as well as the accounting profession. Sensible measures are needed by educators in order to (1) chose teaching methods matching prerequisite skills among a heterogeneous student body...... outcomes is a complex matter requiring sensible measures for both declarative knowledge (ability to verbalize pertinent facts or processes) and procedural knowledge (intellectual skills). The study uses a multitude of measures based on a hierarchical separation of intellectual skills originally suggested...

  16. Measuring Learning Outcomes in Auditing Education

    DEFF Research Database (Denmark)

    Holm, Claus; Steenholdt, Niels

    2003-01-01

    The ability to provide sensible measures for learning outcomes in accounting education is under increased scrutiny. In this paper we use a learner perspective in auditing education, which reflects that some students taking accounting classes also are provided with on-the-job training in accounting...... firms. Hence knowledge about learning outcomes for different groups of students is essential information for educators as well as the accounting profession. This paper extends prior research on the role of declarative and procedural knowledge in performing auditing tasks. Measuring learning outcomes...... is a complex matter requiring sensible measures for both declarative knowledge (ability to verbalize pertinent facts or processes) and procedural knowledge (intellectual skills). The study uses a multitude of measures based on a hierarchical separation of intellectual skills originally suggested by Gagné (1984...

  17. Measuring participation outcomes in rehabilitation medicine

    NARCIS (Netherlands)

    van der Zee, C.H.

    2013-01-01

    We developed the Utrecht Scale for Evaluation of Rehabilitation-Participation (USER-Participation) to fulfill the need for a generic measurement instrument to assess outcomes of outpatient rehabilitation programmes. The USER-Participation assesses three aspects of participation, thereby measuring bo

  18. Introducing the Concept of the Minimally Important Difference to Determine a Clinically Relevant Change on Patient-Reported Outcome Measures in Patients with Intermittent Claudication

    Energy Technology Data Exchange (ETDEWEB)

    Conijn, Anne P., E-mail: a.p.conijn@amc.nl [Academic Medical Center, Departments of Vascular Surgery and Interventional Radiology (Netherlands); Jonkers, Wilma, E-mail: wilma.jonkers@achmea.nl [Achmea Insurances, Division of Health Care (Netherlands); Rouwet, Ellen V., E-mail: e.rouwet@erasmusmc.nl [Erasmus Medical Center, Department of Vascular Surgery (Netherlands); Vahl, Anco C., E-mail: a.c.vahl@olvg.nl [Onze Lieve Vrouwe Gasthuis, Department of Vascular Surgery (Netherlands); Reekers, Jim A., E-mail: j.a.reekers@amc.nl [Academic Medical Center, Department of Radiology (Netherlands); Koelemay, Mark J. W., E-mail: m.j.koelemaij@amc.nl [Academic Medical Center, Department of vascular surgery (Netherlands)

    2015-10-15

    PurposeThe minimally important difference (MID) represents the smallest change in score on patient-reported outcome measures that is relevant to patients. The aim of this study was to introduce the MID for the Vascular Quality of Life Questionnaire (VascuQol) and the walking impairment questionnaire (WIQ) for patients with intermittent claudication (IC).MethodsIn this multicenter study, we recruited 294 patients with IC between July and October 2012. Patients completed the VascuQol, with scores ranging from 1 to 7 (worst to best), and the WIQ, with scores ranging from 0 to 1 (worst to best) at first visit and after 4 months follow-up. In addition, patients answered an anchor-question rating their health status compared to baseline, as being improved, unchanged, or deteriorated. The MID for improvement and deterioration was calculated by an anchor-based approach, and determined with the upper and lower limits of the 95 % confidence interval of the mean change of the group who had not changed according to the anchor-question.ResultsFor the MID analyses of the VascuQol and WIQ, 163 and 134 patients were included, respectively. The MID values for the VascuQol (mean baseline score 4.25) were 0.87 for improvement and 0.23 for deterioration. For the WIQ (mean baseline score 0.39), we found MID values of 0.11 and −0.03 for improvement and deterioration, respectively.ConclusionIn this study, we calculated the MID for the VascuQol and the WIQ. Applying these MID facilitates better interpretation of treatment outcomes and can help to set treatment goals for individual care.

  19. Subjective and objective outcomes in randomized clinical trials

    DEFF Research Database (Denmark)

    Moustgaard, Helene; Bello, Segun; Miller, Franklin G

    2014-01-01

    providing a classification of clinical trial outcomes and a descriptive study of how outcomes were classified in 200 PubMed indexed clinical trial reports published in 2012. RESULTS: We identified 90 methodological publications with some form of a classification of outcomes. Three distinct definitions were...... "subjective outcome" and "objective outcome" are defined in methodological publications and clinical trial reports. To put this examination into perspective, we also provide an overview of how outcomes are classified more broadly. STUDY DESIGN AND SETTING: A systematic review of methodological publications...

  20. The clinical outcome of childhood masturbation.

    Science.gov (United States)

    Unal, F

    2000-01-01

    This study was performed to investigate the clinical outcome of childhood masturbation. For this purpose 50 children (mean age = 48.7 +/- 24.5 months, 34 girls females and 16 boys males) with masturbation symptoms were examined at first visit to the Department of Child Psychiatry and two years thereafter with psychiatric interviews. The mean masturbation frequency at the initial interview was significantly decreased after two years. It was noted that 39 children (78%) were completely recovered and 11 children (22%) continued to masturbate after two years. Children who did not recover were significantly younger, began to masturbate earlier and masturbated more frequently than others at the time of initial evaluation. It was concluded that the findings about the beneficial effect of sedative drugs in combination with parental guidance, education and means for behavior modification were promising.

  1. The International Dermatology Outcome Measures Group

    DEFF Research Database (Denmark)

    Gottlieb, Alice B; Levin, Adriane A; Armstrong, April W;

    2015-01-01

    As quality standards are increasingly in demand throughout medicine, dermatology needs to establish outcome measures to quantify the effectiveness of treatments and providers. The International Dermatology Outcome Measures Group was established to address this need. Beginning with psoriasis......, the group aims to create a tool considerate of patients and providers using the input of all relevant stakeholders in assessment of disease severity and response to treatment. Herein, we delineate the procedures through which consensus is being reached and the future directions of the project....

  2. Gender differences in clinical outcomes for cocaine dependence: Randomized clinical trials of behavioral therapy and disulfiram✩

    Science.gov (United States)

    DeVito, Elise E.; Babuscio, Theresa A.; Nich, Charla; Ball, Samuel A.; Carroll, Kathleen M.

    2014-01-01

    Background Despite extensive research on gender differences in addiction, there are relatively few published reports comparing treatment outcomes for women versus men based on evidence-based treatments evaluated in randomized clinical trials. Methods An aggregate sample comprised of data from five randomized clinical trials of treatment for cocaine dependence (N = 434) was evaluated for gender differences in clinical outcomes. Secondary analyses compared gender differences in outcome by medication condition (disulfiram versus no medication) and across multiple behavioral treatment conditions. Results Women, compared with men, had poorer treatment outcomes on multiple measures of cocaine use during treatment and at post-treatment follow-up. These results appear to be primarily accounted for by disulfiram being less effective in women compared with men. There was no evidence of meaningful gender differences in outcome as a function of the behavioral therapies evaluated. Conclusions These findings suggest that women and men may benefit to similar degrees from some empirically validated behavioral treatments for addiction. Conversely, some addiction pharmacotherapies, such as disulfiram, may be associated with poorer outcomes among women relative to men and point to the need for careful assessment of pharmacological treatments in both sexes prior to widespread clinical implementation. PMID:25457739

  3. How customer satisfaction can influence clinical outcome in a back specialty clinic.

    Science.gov (United States)

    Reznik, B

    1994-01-01

    Determining what defines quality is the aim of the study produced at the Texas Back Institute. Bob Reznik, M.B.A., vice president of the institute, presents a methodology for measuring the outcomes of clinical care and relating it to physician performance on a variety of levels.

  4. The National Anesthesia Clinical Outcomes Registry.

    Science.gov (United States)

    Liau, Adrian; Havidich, Jeana E; Onega, Tracy; Dutton, Richard P

    2015-12-01

    The Anesthesia Quality Institute (AQI) was chartered in 2008 by the American Society of Anesthesiologists to develop the National Anesthesia Clinical Outcomes Registry (NACOR). In this Technical Communication, we will describe how data enter NACOR, how they are authenticated, and how they are analyzed and reported. NACOR accepts case-level administrative, clinical, and quality capture data from voluntarily participating anesthesia practices and health care facilities in the United States. All data are transmitted to the AQI in summary electronic files generated by billing, quality capture, and electronic health care record software, typically on a monthly basis. All data elements are mapped to fields in the NACOR schema in accordance with a publicly available data dictionary. Incoming data are loaded into NACOR by AQI technologists and are subject to both manual and automated review to identify systematically missing elements, miscoding, and inadvertent corruption. Data are deidentified in compliance with Health Insurance Portability and Accountability Act regulations. The database server of AQI, which houses the NACOR database, is protected by 2 firewalls within the American Society of Anesthesiologists' network infrastructure; this system has not been breached. The NACOR Participant User File, a deidentified case-level dataset of information from NACOR, is available to researchers at participating institutions. NACOR architecture and the nature of the Participant User File include both strengths and weaknesses.

  5. Cinacalcet and Clinical Outcomes in Dialysis.

    Science.gov (United States)

    Komaba, Hirotaka; Fukagawa, Masafumi

    2015-01-01

    Secondary hyperparathyroidism (SHPT) is a common complication of end-stage renal disease and is one of the most prominent causes of a markedly increased risk of death and cardiovascular disease in this patient population. Cinacalcet hydrochloride is a new option for the treatment of SHPT, and the efficacy and effectiveness to lower parathyroid hormone levels and to improve control of mineral metabolism, even in patients with severe disease, has been well established in many clinical trials and observational studies. Currently, the focus has moved to the impact of cinacalcet on hard clinical outcomes, and two randomized controlled trials, ADVANCE and EVOLVE, have been performed to assess the effects of cinacalcet on cardiovascular calcification and the risk of cardiovascular events and mortality, respectively. Although the primary analysis of both trials did not find significant effects of cinacalcet, the benefit of cinacalcet was suggested in the subanalyses in which the potential problems of the trials were taken into account. These positive results are consistent with experimental studies showing favorable effects of cinacalcet on bone metabolism and vascular calcification, providing plausibility to support the beneficial effects of cinacalcet. Definitive evidence is, however, still lacking, and further efforts should be made to establish the optimal role of cinacalcet in the treatment of SHPT.

  6. Controlled outcome studies of child clinical hypnosis.

    Science.gov (United States)

    Adinolfi, Barbara; Gava, Nicoletta

    2013-09-01

    Background Hypnosis is defined as "as an interaction in which the hypnotist uses suggested scenarios ("suggestions") to encourage a person's focus of attention to shift towards inner experiences". Aim of the work The focus of this review is to summarize the findings of controlled outcome studies investigating the potential of clinical hypnosis in pediatric populations. We will examine the following themes: anesthesia, acute and chronic pain, chemotherapy-related distress, along with other specific medical issues. Results Hypnosis is an effective method to reduce pain and anxiety before, during and after the administration of anesthetics, during local dental treatments, invasive medical procedures and in burn children. Hypnosis can be successfully used to manage recurrent headaches, abdominal pain, irritable bowel syndrome and chemotherapy-related distress. Hypnosis has an important role in managing symptoms and improving the quality of life of children suffering from asthma and cystic fibrosis and in facilitating the treatment of insomnia in school-age children. Finally, hypnosis can be effectively used for the treatment of some habitual disorders such as nocturnal enuresis and dermatologic conditions, including atopic dermatitis and chronic eczema Conclusions Clinical hypnosis seems to be a useful, cheap and side-effects free tool to manage fear, pain and several kinds of stressful experiences in pediatric populations. Children who receive self-hypnosis trainings achieve significantly greater improvements in their physical health, quality of life, and self-esteem.

  7. Clinical Features and Outcome of Mucormycosis

    Science.gov (United States)

    Camara-Lemarroy, Carlos Rodrigo; González-Moreno, Emmanuel Irineo; Rodríguez-Gutiérrez, René; Rendón-Ramírez, Erick Joel; Ayala-Cortés, Ana Sofía; Fraga-Hernández, Martha Lizeth; García-Labastida, Laura; Galarza-Delgado, Dionicio Ángel

    2014-01-01

    Mucormycosis (MCM) is a life-threatening infection that carries high mortality rates despite recent advances in its diagnosis and treatment. The objective was to report 14 cases of mucormycosis infection and review the relevant literature. We retrospectively analyzed the demographic and clinical data of 14 consecutive patients that presented with MCM in a tertiary-care teaching hospital in northern Mexico. The mean age of the patients was 39.9 (range 5–65). Nine of the patients were male. Ten patients had diabetes mellitus as the underlying disease, and 6 patients had a hematological malignancy (acute leukemia). Of the diabetic patients, 3 had chronic renal failure and 4 presented with diabetic ketoacidosis. All patients had rhinocerebral involvement. In-hospital mortality was 50%. All patients received medical therapy with polyene antifungals and 11 patients underwent surgical therapy. Survivors were significantly younger and less likely to have diabetes than nonsurvivors, and had higher levels of serum albumin on admission. The clinical outcome of patients with MCM is poor. Uncontrolled diabetes and age are negative prognostic factors. PMID:25210515

  8. Clinical Features and Outcome of Mucormycosis

    Directory of Open Access Journals (Sweden)

    Carlos Rodrigo Camara-Lemarroy

    2014-01-01

    Full Text Available Mucormycosis (MCM is a life-threatening infection that carries high mortality rates despite recent advances in its diagnosis and treatment. The objective was to report 14 cases of mucormycosis infection and review the relevant literature. We retrospectively analyzed the demographic and clinical data of 14 consecutive patients that presented with MCM in a tertiary-care teaching hospital in northern Mexico. The mean age of the patients was 39.9 (range 5–65. Nine of the patients were male. Ten patients had diabetes mellitus as the underlying disease, and 6 patients had a hematological malignancy (acute leukemia. Of the diabetic patients, 3 had chronic renal failure and 4 presented with diabetic ketoacidosis. All patients had rhinocerebral involvement. In-hospital mortality was 50%. All patients received medical therapy with polyene antifungals and 11 patients underwent surgical therapy. Survivors were significantly younger and less likely to have diabetes than nonsurvivors, and had higher levels of serum albumin on admission. The clinical outcome of patients with MCM is poor. Uncontrolled diabetes and age are negative prognostic factors.

  9. Acute demyelinating encephalomyelitis: Clinical characteristics and outcome

    Directory of Open Access Journals (Sweden)

    Ahmed Farag Elhassanien

    2013-01-01

    Full Text Available Background: ADEM, although relatively uncommon, is probably under-recognized. Objectives: To spotlight the clinical profile and therapeutic outcome of children with ADEM. Materials and Methods: This is a prospective study of patients with ADEM who were admitted to the Pediatric Departments in Aladan and Alfarawanya Hospitals in Kuwait, from January 2009 to January 2011. Clinical, microbiological and radiological data were analyzed. Results: Of 48 patients presented with acute neurological symptoms and signs, 21 patients fulfilled criteria for ADEM. 80.95% of cases were presenting in winter and spring, 57% of patients had a history of upper respiratory tract illness. The commonest presentations were motor deficits, convulsions and altered consciousness. CSF virology studies showed herpes simplex virus (HSV and Epstein-Barr virus (EBV (3 patients whereas nasal and nasopharyngeal swab showed evidence of influenza H1N1 virus (1 patient. Brain MRI was performed in all patients and revealed multiple hyperintense supratentorial brain lesions on T2/FLAIR images. 85.7% of patients had cortical and/or subcortical white matter lesions which were bilateral and asymmetric in location and size. Conclusion: ADEM although rare must be considered in children with acute onset of neurological signs and symptoms and must be distinguished from any acute neurological insult.

  10. THORACOLUMBAR BURST FRACTURE: STRUCTURAL CHANGES AND CLINICAL OUTCOME OF TREATMENT

    Directory of Open Access Journals (Sweden)

    Rodrigo Arnold Tisot

    2016-03-01

    Full Text Available ABSTRACT Objective: To evaluate the correlation between structural changes in burst fractures of thoracic and lumbar spine with clinical outcome of the treatment. Methods: A retrospective study in 25 patients with fractures of thoracic and lumbar spine burst fractures without neurological deficit. Eleven patients underwent conservative treatment and for the remaining the treatment was surgical. All patients were followed up for at least 24 months. The cases were evaluated by a protocol that included: posttraumatic measurement of kyphosis, vertebral body collapse and narrowing of the spinal canal, the visual analog scale of pain, and the quality of life questionnaire SF-36 at the follow-up. For statistical analysis, the significance level was 5% and the software SPSS 18.0 was used. Results: No statistically significant difference was observed when comparing the clinical outcomes of one treatment over another. Similarly, there was no statistically significant correlation between kyphosis and post-traumatic narrowing of the spinal canal with clinical worsening in the follow-up, regardless of the treatment used. We found a positive correlation (p<0.05 between initial collapse and SF-36 domains in both groups (operated and non-operated. Conclusion: There was no significant superiority of one treatment over the other, and no correlation was found between kyphosis and spinal canal narrowing in burst fractures of the thoracic and lumbar spine without neurological deficit. However, there was correlation between initial collapse and clinical outcome in some domains of the SF-36 questionnaire.

  11. Community to clinic navigation to improve diabetes outcomes

    Directory of Open Access Journals (Sweden)

    Nancy E. Schoenberg

    2017-03-01

    Full Text Available Rural residents experience rates of Type 2 Diabetes Mellitus (T2DM that are considerably higher than their urban or suburban counterparts. Two primary modifiable factors, self-management and formal clinical management, have potential to greatly improve diabetes outcomes. “Community to Clinic Navigation to Improve Diabetes Outcomes,” is the first known randomized clinical trial pilot study to test a hybrid model of diabetes self-management education plus clinical navigation among rural residents with T2DM. Forty-one adults with T2DM were recruited from two federally qualified health centers in rural Appalachia from November 2014–January 2015. Community health workers provided navigation, including helping participants understand and implement a diabetes self-management program through six group sessions and, if needed, providing assistance in obtaining clinic visits (contacting providers' offices for appointments, making reminder calls, and facilitating transportation and dependent care. Pre and post-test data were collected on T2DM self-management, physical measures, demographics, psychosocial factors, and feasibility (cost, retention, and satisfaction. Although lacking statistical significance, some outcomes indicate trends in positive directions, including diet, foot care, glucose monitoring, and physical health, including decreased HbA1c and triglyceride levels. Process evaluations revealed high levels of satisfaction and feasibility. Due to the limited intervention dose, modest program expenditures (~$29,950, and a severely affected population most of whom had never received diabetes education, outcomes were not as robust as anticipated. Given high rates of satisfaction and retention, this culturally appropriate small group intervention holds promise for hard to reach rural populations. Modifications should include expanded recruitment venues, sample size, intervention dosage and longer term assessment.

  12. Routine outcome measures in Norway: Only partly implemented.

    Science.gov (United States)

    Ruud, Torleif

    2015-01-01

    Norway has not had any strategy exclusively for the implementation of routine outcome measurement in the mental health services, but some efforts have been made as part of strategies for a national patient register and quality indicators. Fifteen years after the decision to make the rating of the Global Assessment of Functioning scale (GAF) mandatory at admission and discharge of each treatment episode in adult mental health services, this is still not fully implemented. An unknown and probably very low proportion of mental health services use GAF as a routine outcome measure in everyday clinical practice. Well-established electronic patient records in the mental health services and established procedures for reporting routine data to the National Patient Register should make it possible to collect and use routine outcome data. Implementation of routine outcome measurement in mental health services must be done with due emphasis on the critical steps in the various phases of the implementation process. The regional health authorities have a key role in establishing electronic systems that make relevant outcome measurements available in a seamless way for clinicians as well as for patients, and by contributing to a culture where quality and outcome are valued and given priority.

  13. FETAL ECHOCARDIOGRAPHY: A STUDY OF CLINICAL OUTCOME

    Directory of Open Access Journals (Sweden)

    Rajanish

    2014-01-01

    Full Text Available BACKGROUND : S tructural abnormalities of the heart and great vessels are fairly common congenital lab normalities with the incidenceof8 in 1000 live births. With the advent of real time scanners fetal cardia can atomy can be analyze d echocardiographically. The earlier diagnosis will make an impact on clinical management of fetus with congenital heart disease. It helps intimely triage and optimal management of specific congenital heart disease either structural , functional orarrhythmia . OBJECTIVES : This study was conducted to note the spectrum of congenital heart diseases detected on fetal echo in pregnant mothers referred with high risk for CHD sand to assess the outcome of prenatally detected congenital heart diseases. MATERIAL S AND METHODS : T he study is aprospective descriptive study conducted in a tertiary care pediatric hospital in Mumbai over period of one year . P regnant mothers were referred for fetal echo , where pregnancy was considered as high risk for CHDs due to maternal , fetalfactorsorabnormallevel 1 scan.Fetal echowas performed by a trained pediatric cardiologistat 18 to 20 week of gestation using HP sonos 2000 echocardiographicmachinewith3/3.5 Hz transducer. Cardiac lesionsandoutcome of pregnancy was noted by postnatal follow - up of patients. RESULTS : A total of 170 patients underwent fetal echo , 13 patients have not delivered and 48 were lost to follow - up. Fetal echo was normal in 130(76.4% and abnormalities were detected in 40(23.5%.Structural anomalies were seen in 24(14.1% , arrhythmia in 5(2.9% and functional abnormalities in 11(6.4%.On outcome analysis84 (77.1% arealive , IUD /terminationof pregnancyoccurred in 18(16.5% , neonatal death in 6 (5.5% , infant death in 1 (0.9%. CONCLUSIONS : All ranges of CHDs can be diagnosed by fetal echocardiography . O utcome of prenatally detected complex congenital heart disease is poor ; nonetheless earlier detection provides a n opportunity for early interventions and

  14. Biocompatible Peritoneal Dialysis Fluids: Clinical Outcomes

    Directory of Open Access Journals (Sweden)

    Yeoungjee Cho

    2012-01-01

    Full Text Available Peritoneal dialysis (PD is a preferred home dialysis modality and has a number of added advantages including improved initial patient survival and cost effectiveness over haemodialysis. Despite these benefits, uptake of PD remains relatively low, especially in developed countries. Wider implementation of PD is compromised by higher technique failure from infections (e.g., PD peritonitis and ultrafiltration failure. These are inevitable consequences of peritoneal injury, which is thought to result primarily from continuous exposure to PD fluids that are characterised by their “unphysiologic” composition. In order to overcome these barriers, a number of more biocompatible PD fluids, with neutral pH, low glucose degradation product content, and bicarbonate buffer have been manufactured over the past two decades. Several preclinical studies have demonstrated their benefit in terms of improvement in host cell defence, peritoneal membrane integrity, and cytokine profile. This paper aims to review randomised controlled trials assessing the use of biocompatible PD fluids and their effect on clinical outcomes.

  15. Outcome Modeling Using Clinical DVH Data

    CERN Document Server

    Gordon, JJ

    2015-01-01

    Purpose: To quantify the ability of correlation and regression analysis to extract the normal lung dose-response function from dose volume histogram (DVH) data. Methods: A local injury model is adopted, in which radiation-induced damage (functional loss) G is the integral of the DVH with function R(D). RP risk is H(G) where H() is the sigmoid cumulative distribution of functional reserve. RP incidence is a Bernoulli function of risk. A homogeneous patient cohort is assumed, allowing non-dose-related factors to be ignored. Clinically realistic DVHs are combined with the injury model to simulate RP data. Results: Correlation analysis is often used to identify predictor variables that are correlated with outcome, for inclusion in a predictive model. In the local injury model, all DVH metrics VD contribute to damage. Correlation analysis therefore has limited value. The subset of VD significantly correlated with incidence varies randomly from trial to trial due to random variations in the DVH set, and does not ne...

  16. Using the analytic hierarchy process to elicit patient preferences: prioritizing multiple outcome measures of antidepressant drug treatment

    NARCIS (Netherlands)

    Hummel, M.J.M.; Volz, F.; Manen, van J.G.; Danner, M.; Dintsios, C.-M.; IJzerman, M.J.; Gerber, A.

    2012-01-01

    Background and Objective: In health technology assessment, the evidence obtained from clinical trials regarding multiple clinical outcomes is used to support reimbursement claims. At present, the relevance of these outcome measures for patients is, however, not systematically assessed, and judgments

  17. Midterm clinical outcomes following arthroscopic transosseous rotator cuff repair

    Directory of Open Access Journals (Sweden)

    Brody A Flanagin

    2016-01-01

    Full Text Available Purpose: Arthroscopic transosseous (TO rotator cuff repair has recently emerged as a new option for surgical treatment of symptomatic rotator cuff tears. Limited data is available regarding outcomes using this technique. This study evaluated midterm clinical outcomes following a novel arthroscopic TO (anchorless rotator cuff repair technique. Materials and Methods: A consecutive series of 107 patients and 109 shoulders underwent arthroscopic TO (anchorless rotator cuff repair for a symptomatic full-thickness tear. Pre and postoperative range of motion (ROM was compared at an average of 11.8 months. Postoperative outcome scores were obtained at an average of 38.0 months. Statistical analysis was performed to compare pre and postoperative ROM data. Univariate analysis was performed using Student′s t-test to compare the effect of other clinical characteristics on final outcome. Results: Statistically significant improvements were noted in forward flexion, external rotation and internal rotation (P < 0.0001. Average postoperative subjective shoulder value was 93.7, simple shoulder test 11.6, and American Shoulder and Elbow Surgeons (ASES score 94.6. According to ASES scores, results for the 109 shoulders available for final follow-up were excellent in 95 (87.1%, good in 8 (7.3%, fair in 3 (2.8%, and poor in 3 (2.8%. There was no difference in ROM or outcome scores in patients who underwent a concomitant biceps procedure (tenodesis or tenotomy compared with those who did not. Furthermore, there was no significant difference in outcome between patients who underwent either biceps tenodesis or tenotomy. Age, history of "injury" preceding the onset of pain, tear size, number of TO tunnels required to perform the repair, and presence of fatty infiltration did not correlate with postoperative ROM or subjective outcome measures at final follow-up. Two complications and four failures were noted. Conclusions: Arthroscopic TO rotator cuff repair technique

  18. Analysis of repeated outcome measures from longitudinal studies

    Institute of Scientific and Technical Information of China (English)

    Yuanjia WANG; Naihua DUAN

    2011-01-01

    @@ In many clinical studies repeated measurements of an outcome are collected over time.For example,in an 8-week study of treatment for obsessive compulsive disorder,the severity of the disorder may be measured weekly using the Yale-Brown-Obsessive-Compulsive-Disorder-Scale (YBOCS).For each study participant who completes the study,there will be nine repeated measures of YBOCS (a baseline assessment plus eight assessments during the course of treatment).Such a study in which participants are followed and measured repeatedly over time is called a longitudinal study and the resulting data are called longitudinal data.

  19. Assessing quality-of-life outcomes in cardiovascular clinical research.

    Science.gov (United States)

    Mark, Daniel B

    2016-05-01

    The field of quality-of-life (QOL) measurement grew out of attempts in the 1960s and 1970s to connect the ever-increasing levels of public expenditure on technology-based health care for chronic diseases with evidence of the benefits and harms to patients. Most of the concepts, methods, and standards for measuring QOL were derived from psychometrics, but the degree to which current tools adhere to these methods varies greatly. Despite the importance of QOL, patient-reported outcomes are not measured in most cardiovascular clinical trials. Lack of familiarity with QOL measures and their interpretation, and unrealistic expectations about the information these measures can provide, are obstacles to their use. Large clinical trials of revascularization therapy for coronary artery disease and medical treatments for heart failure show small-to-moderate QOL effects, primarily detected with disease-specific instruments. Larger treatment effects, seen in trials of device therapy for heart failure and ablation therapy for atrial fibrillation, have been detected with both generic and disease-specific instruments. A large gap remains between the parameters currently being measured in clinical research and the data needed to incorporate the 'patient's voice' into therapeutic decision-making.

  20. Standardized clinical outcome rating scale for depression for use in clinical practice.

    Science.gov (United States)

    Zimmerman, Mark; Posternak, Michael A; Chelminski, Iwona; Friedman, Michael

    2005-01-01

    The integration of research into clinical practice to conduct effectiveness studies faces multiple obstacles. One obstacle is the burden of completing research measures of outcome. A simple, reliable, and valid measure that could be rated at every visit, incorporated into a clinician's progress note, and reflect the DSM-IV definition of a major depressive episode (including partial and full remission from the episode) would enhance the ability to conduct effectiveness research. The goal of the present study was to examine the reliability and validity of such a measure. Three hundred and three psychiatric outpatients who were being treated for a DSM-IV major depressive episode were rated on the Standardized Clinical Outcome Rating for Depression (SCOR-D), 17-item Hamilton Rating Scale for Depression, Montgomery-Asberg Depression Rating Scale, and the Global Assessment of Functioning. We examined the correlation between the SCOR-D and the other measures, and conducted an analyses of variance to compare mean values on these measures for each rating point on the SCOR-D. The inter-rater reliability of the SCOR-D dimensional ratings and categorical determination of remission were high. The SCOR-D was highly correlated with the other scales, and there were significant differences on the other measures of depression severity between each adjacent rating level of the SCOR-D. The SCOR-D is a brief standardized outcome measure linked to the DSM-IV approach toward defining remission that can be incorporated into routine clinical practice without adding undue burden to the treating clinician with some evidence of reliability and validity. This measure could make it more feasible to conduct effectiveness studies in clinical practice.

  1. The Assessment of Patient Clinical Outcome: Advantages, Models, Features of an Ideal Model

    Directory of Open Access Journals (Sweden)

    Mou’ath Hourani

    2016-06-01

    Full Text Available Background: The assessment of patient clinical outcome focuses on measuring various aspects of the health status of a patient who is under healthcare intervention. Patient clinical outcome assessment is a very significant process in the clinical field as it allows health care professionals to better understand the effectiveness of their health care programs and thus for enhancing the health care quality in general. It is thus vital that a high quality, informative review of current issues regarding the assessment of patient clinical outcome should be conducted. Aims & Objectives: 1 Summarizes the advantages of the assessment of patient clinical outcome; 2 reviews some of the existing patient clinical outcome assessment models namely: Simulation, Markov, Bayesian belief networks, Bayesian statistics and Conventional statistics, and Kaplan-Meier analysis models; and 3 demonstrates the desired features that should be fulfilled by a well-established ideal patient clinical outcome assessment model. Material & Methods: An integrative review of the literature has been performed using the Google Scholar to explore the field of patient clinical outcome assessment. Conclusion: This paper will directly support researchers, clinicians and health care professionals in their understanding of developments in the domain of the assessment of patient clinical outcome, thus enabling them to propose ideal assessment models.

  2. C2-fractures: part II. A morphometrical analysis of computerized atlantoaxial motion, anatomical alignment and related clinical outcomes

    OpenAIRE

    Koller, Heiko; Acosta, Frank; Forstner, Rosemarie; Zenner, Juliane; Resch,Herbert; Tauber, Mark; Lederer, Stefan; Auffarth, Alexander; Hitzl, Wolfgang

    2009-01-01

    Knowledge on the outcome of C2-fractures is founded on heterogenous samples with cross-sectional outcome assessment focusing on union rates, complications and technical concerns related to surgical treatment. Reproducible clinical and functional outcome assessments are scant. Validated generic and disease specific outcome measures were rarely applied. Therefore, the aim of the current study is to investigate the radiographic, functional and clinical outcome of a patient sample with C2-fractur...

  3. Long-term clinical outcome of neonatal EEG findings.

    Science.gov (United States)

    Almubarak, Salah; Wong, Peter K H

    2011-04-01

    The aim of the study is to determine how specific EEG findings during neonatal period correlate with clinical outcome on follow-up. This is a retrospective study of 118 term newborns who had EEG in the first month of life and subsequent clinical assessment between 4 and 16 years. Clinical neurologic outcome was classified into "favorable" when patients had no or only mild limitation in assessment, "unfavorable" when patients had moderate to severe abnormalities in assessment, and "epilepsy" when patients had seizures. Of the 118 neonates, 36 (30.5%) had favorable and 82 (69.5%) had unfavorable outcome; 89 (75.4%) had epilepsy and 28 (23.7%) had not. Sixty-seven (57%) had abnormal EEG background of which 56 had both unfavorable outcome and epilepsy; 102 (86%) had sharp transient discharges of which 75 had unfavorable outcome; 20 (17%) had ictal epileptiform discharges of which 18 had unfavorable outcome; 98 (83%) had abnormal overall EEG impression of which 77 had unfavorable outcome and 80 had epilepsy. Abnormal EEG background (particularly suppression) during neonatal period may be predictive of Unfavorable outcome. Overall impression of EEG may be predictive of clinical outcome, even when individual parameters were not predictive. Other findings did not appear to be predictive.

  4. Using an open source observational tool to measure the influence of the doctor's consulting style and the computer system on the outcomes of the clinical consultation.

    Science.gov (United States)

    De Lusignan, Simon; Kumarapeli, Pushpa; Debar, Safia; Kushniruk, Andre W; Pearce, Chris

    2009-01-01

    Computerization of general practice is an international phenomenon. Many of the Electronic Patient Record (EPR) systems have developed organically with considerable variation in their interface and functionality. Consequently they have differing impact on the clinical consultation. There is a dearth of tools available to study their impact on the consultation. The objective is to use ALFA to film and analyze a simulated clinical consultation. We used the ALFA (Activity Log File Aggregation) open source toolkit, to make video based observation and analysis of the computer mediated consultation. ALFA enables precise comparison of core elements of EPR systems. It allows multiple video channels including screen capture, data about computer use, and verbal interactions to be synchronized, timed and navigated through for analysis. The toolkit is free and can be downloaded under an open source license from www.biomedicalinformatics.info/alfa/. Its outputs, which include Unified Modelling Language (UML), provide the evidence-base for assessing the impact of the computer on the consultation the designing of EPR systems. ALFA has been used to compare different brands of primary care computer systems; nurse case-load selection and consultation in psychiatry.

  5. Combining clinical variables to optimize prediction of antidepressant treatment outcomes.

    Science.gov (United States)

    Iniesta, Raquel; Malki, Karim; Maier, Wolfgang; Rietschel, Marcella; Mors, Ole; Hauser, Joanna; Henigsberg, Neven; Dernovsek, Mojca Zvezdana; Souery, Daniel; Stahl, Daniel; Dobson, Richard; Aitchison, Katherine J; Farmer, Anne; Lewis, Cathryn M; McGuffin, Peter; Uher, Rudolf

    2016-07-01

    The outcome of treatment with antidepressants varies markedly across people with the same diagnosis. A clinically significant prediction of outcomes could spare the frustration of trial and error approach and improve the outcomes of major depressive disorder through individualized treatment selection. It is likely that a combination of multiple predictors is needed to achieve such prediction. We used elastic net regularized regression to optimize prediction of symptom improvement and remission during treatment with escitalopram or nortriptyline and to identify contributing predictors from a range of demographic and clinical variables in 793 adults with major depressive disorder. A combination of demographic and clinical variables, with strong contributions from symptoms of depressed mood, reduced interest, decreased activity, indecisiveness, pessimism and anxiety significantly predicted treatment outcomes, explaining 5-10% of variance in symptom improvement with escitalopram. Similar combinations of variables predicted remission with area under the curve 0.72, explaining approximately 15% of variance (pseudo R(2)) in who achieves remission, with strong contributions from body mass index, appetite, interest-activity symptom dimension and anxious-somatizing depression subtype. Escitalopram-specific outcome prediction was more accurate than generic outcome prediction, and reached effect sizes that were near or above a previously established benchmark for clinical significance. Outcome prediction on the nortriptyline arm did not significantly differ from chance. These results suggest that easily obtained demographic and clinical variables can predict therapeutic response to escitalopram with clinically meaningful accuracy, suggesting a potential for individualized prescription of this antidepressant drug.

  6. Patient reported outcome measures in neurogenic bladder.

    Science.gov (United States)

    Clark, Roderick; Welk, Blayne

    2016-02-01

    Many interventions for neurogenic bladder patients are directed towards improving quality of life (QOL). Patient reported outcome measures (PROMs) are the primary method of evaluating QOL, and they provide an important quantification of symptoms which can't be measured objectively. Our goal was to review general measurement principles, and identify and discuss PROMs relevant to neurogenic bladder patients. We identify two recent reviews of the state of the literature and updated the results with an additional Medline search up to September 1, 2015. Using the previous identified reviews, and our updated literature review, we identified 16 PROMs which are used for the assessment of QOL and symptoms in neurogenic bladder patients. Several are specifically designed for neurogenic bladder patients, such as the Qualiveen (for neurogenic bladder related QOL), and the Neurogenic Bladder Symptom Score (NBSS) (for neurogenic bladder symptoms). We also highlight general QOL measures for patients with multiple sclerosis (MS) and spinal cord injury (SCI) which include questions about bladder symptoms, and incontinence PROMs which are commonly used, but not specifically designed for neurogenic bladder patients. It is essential for clinicians and researchers with an interest in neurogenic bladder to be aware of the current PROMs, and to have a basic understanding of the principals of measurement in order to select the most appropriate one for their purpose.

  7. Technology Deployment to Improve Clinical Outcomes

    Institute of Scientific and Technical Information of China (English)

    TM Judd; L Jacobs; M Jansen; B Birch

    2016-01-01

    Improved child, newborn, and maternal health (CNM) is a top priority in developing countries. Many factors must be addressed simultaneously to improve clinical outcomes for CNM. A public-private project in Haiti that will deploy the World Health Organization (WHO) evidence-based medicine (EBM) and essential interventions utilizing CNM healthcare technologies (HT), is expected to be a model for improving national health systems. The CNM mortality rates in Haiti are the highest in the western hemisphere with rates similar to those found in Afghanistan and several African countries. Several factors perpetuating this crisis are noted, as well as the most cost-effective interventions proven to decrease CNM mortality rates in low-and middle-income countries. To create major change in health system infrastructure, two strategies are presented, requiring appropriate and leading-edge health technologies (HT),e.g., wireless cellular-network-based Telemedicine (TM): (1) Development of a countrywide network of geographical“Community Care Grids” to facilitate implementation of frontline interventions; (2) The construction of a central hospital (called Bethesda Referral and Teaching Hospital-BRTH NGO) that will provide secondary and tertiary care for communities throughout the country, including helping local hospitals and clinics practice EBM care. We believe that these strategies-supported by HT will fast track improvement in CNM mortality rates throughout the country and that in a relatively short period of time Haiti’s health care system will be among the leaders in the region. Primary factors contributing to the CNM crisis, all addressed by TM: (1) Limited access: demographics, geography, cost, transportation; (2) Inadequate health care facilities: less than 20 NICU beds for 10 million population; BRTH to provide 80 bed NICU and 40 bed PICU in 225 bed hospital; (3) Health care practitioners: inadequate numbers and training; (4) Low% of skilled attendants now at

  8. Combining clinical variables to optimize prediction of antidepressant treatment outcomes

    OpenAIRE

    Iniesta, R.; Malki, K.; Maier, W; Rietschel, M.; Mors, O; Hauser, J; Henigsberg, N.; Dernovsek, M. Z.; Souery, D.; Stahl, D.; Dobson, R.; Aitchison, K. J.; Farmer, A; Lewis, C.M.; McGuffin, P.

    2016-01-01

    The outcome of treatment with antidepressants varies markedly across people with the same diagnosis. A clinically significant prediction of outcomes could spare the frustration of trial and error approach and improve the outcomes of major depressive disorder through individualized treatment selection. It is likely that a combination of multiple predictors is needed to achieve such prediction. We used elastic net regularized regression to optimize prediction of symptom improvement and remissio...

  9. Clinical outcome of 371 episodes of peritoneal dialysis related peritonitis

    Institute of Scientific and Technical Information of China (English)

    唐碧雯

    2014-01-01

    Objective To analyze the clinical outcome of PD related peritonitis in our center.Methods All patients who developed PD related peritonitis between January 2004and December 2010 in Renji Hospital of Shanghai Jiao Tong University School of Medicine were included.Outcomes of PD related peritonitis were analyzed.Results A total of 220 patients developed 371

  10. Immediate Implants: Clinical Guidelines for Esthetic Outcomes

    Directory of Open Access Journals (Sweden)

    Mohammad A. Javaid

    2016-06-01

    Full Text Available Research has shown that tooth loss results in morphological changes in alveolar ridge that may influence the subsequent implant placement. Immediate implant placement was introduced as a possible means to limit bone resorption and reduce the number of surgical procedures following tooth extraction. Histological and clinical evidence from human clinical studies showing efficacy of immediate implants has come to light over the last decade or so. However, immediate implant placement is a challenging surgical procedure and requires proper case selection and surgical technique. Furthermore, there appears to be a lack of clinical guidelines for immediate implant placement case selection. Therefore, the aim of this mini-review is to analyze critical evidence from human studies in order to establish clinical guidelines which may help clinicians in case selection when considering immediate implant placement protocol.

  11. Yoga & Cancer Interventions: A Review of the Clinical Significance of Patient Reported Outcomes for Cancer Survivors

    Directory of Open Access Journals (Sweden)

    S. Nicole Culos-Reed

    2012-01-01

    Full Text Available Limited research suggests yoga may be a viable gentle physical activity option with a variety of health-related quality of life, psychosocial and symptom management benefits. The purpose of this review was to determine the clinical significance of patient-reported outcomes from yoga interventions conducted with cancer survivors. A total of 25 published yoga intervention studies for cancer survivors from 2004–2011 had patient-reported outcomes, including quality of life, psychosocial or symptom measures. Thirteen of these studies met the necessary criteria to assess clinical significance. Clinical significance for each of the outcomes of interest was examined based on 1 standard error of the measurement, 0.5 standard deviation, and relative comparative effect sizes and their respective confidence intervals. This review describes in detail these patient-reported outcomes, how they were obtained, their relative clinical significance and implications for both clinical and research settings. Overall, clinically significant changes in patient-reported outcomes suggest that yoga interventions hold promise for improving cancer survivors' well-being. This research overview provides new directions for examining how clinical significance can provide a unique context for describing changes in patient-reported outcomes from yoga interventions. Researchers are encouraged to employ indices of clinical significance in the interpretation and discussion of results from yoga studies.

  12. Discrepancies between patient-reported outcome measures when assessing urinary incontinence or pelvic-prolapse surgery

    DEFF Research Database (Denmark)

    Larsen, Michael Due; Lose, Gunnar; Guldberg, Rikke

    2016-01-01

    INTRODUCTION AND HYPOTHESIS: In order to assess the outcome following surgery for urinary incontinence (UI) and pelvic organ prolapse (POP) the importance of patient-reported outcome measures, in addition to the clinical objective measures, has been recognised. The International Consultation...

  13. Outcome Measures in Functional Urology : Towards evaluation through patient reported outcome measures?

    NARCIS (Netherlands)

    L.A. 't Hoen (Lisette)

    2015-01-01

    markdownabstractAbstract Pelvic floor disorders are characterized by four domains: urinary symptoms, anorectal symptoms, pelvic organ prolapse and sexual dysfunction. The symptoms of the different domains have a significant impact on patient’s quality of life. Traditional outcome measures, such a

  14. Core Outcome Sets and Multidimensional Assessment Tools for Harmonizing Outcome Measure in Chronic Pain and Back Pain

    Science.gov (United States)

    Kaiser, Ulrike; Neustadt, Katrin; Kopkow, Christian; Schmitt, Jochen; Sabatowski, Rainer

    2016-01-01

    Core Outcome Sets (COSs) are a set of domains and measurement instruments recommended for application in any clinical trial to ensure comparable outcome assessment (both domains and instruments). COSs are not exclusively recommended for clinical trials, but also for daily record keeping in routine care. There are several COS recommendations considering clinical trials as well as multidimensional assessment tools to support daily record keeping in low back pain. In this article, relevant initiatives will be described, and implications for research in COS development in chronic pain and back pain will be discussed. PMID:27589816

  15. Core Outcome Sets and Multidimensional Assessment Tools for Harmonizing Outcome Measure in Chronic Pain and Back Pain

    Directory of Open Access Journals (Sweden)

    Ulrike Kaiser

    2016-08-01

    Full Text Available Core Outcome Sets (COSs are a set of domains and measurement instruments recommended for application in any clinical trial to ensure comparable outcome assessment (both domains and instruments. COSs are not exclusively recommended for clinical trials, but also for daily record keeping in routine care. There are several COS recommendations considering clinical trials as well as multidimensional assessment tools to support daily record keeping in low back pain. In this article, relevant initiatives will be described, and implications for research in COS development in chronic pain and back pain will be discussed.

  16. Outcomes 'out of africa': the selection and implementation of outcome measures for palliative care in Africa

    Directory of Open Access Journals (Sweden)

    Downing Julia

    2012-01-01

    Full Text Available Abstract Background End-of-life care research across Africa is under-resourced and under-developed. A central issue in research in end-of-life care is the measurement of effects and outcomes of care on patients and families. Little is known about the experiences of health professionals' selection and implementation of outcome measures (OM in clinical care, research, audit, or teaching in Africa. Methods An online survey was undertaken of those using outcome measures across the region, as part of the PRISMA project. A questionnaire addressing the use of OMs was developed for a similar survey in Europe and adapted for Africa. Participants were sampled through the contacts database of APCA. Invitation emails were sent out in January 2010 and reminders in February 2010. Results 168/301 invited contacts (56% from 24 countries responded, with 78 respondents having previously used OM (65% in clinical practice, 12% in research and 23% for both. Main reasons for not using OM were a lack of guidance/training on using and analysing OM, with 49% saying that they would use the tools if this was provided. 40% of those using OM in clinical practice used POS, and 80% used them to assess, evaluate and monitor change. The POS was also the main tool used in research, with the principle criteria for use being validation in Africa, access to the tool and time needed to complete it. Challenges to the use of tools were shortage of time and resources, lack of guidance and training for the professionals, poor health status of patients and complexity of OM. Researchers also have problems analysing OM data. The APCA African POS was the most common version of the POS used, and was reported as a valuable tool for measuring outcomes. Respondents indicated the ideal outcome tool should be short, multi-dimensional and easy to use. Conclusion This was the first survey on professionals' views on OM in Africa. It showed that the APCA African POS was the most frequently OM used

  17. Validity and reliability of patient reported outcomes used in Psoriasis: results from two randomized clinical trials

    Directory of Open Access Journals (Sweden)

    Koo John

    2003-10-01

    Full Text Available Abstract Background Two Phase III randomized controlled clinical trials were conducted to assess the efficacy, safety, and tolerability of weekly subcutaneous administration of efalizumab for the treatment of psoriasis. Patient reported measures of psoriasis-related functionality and health-related quality of life and of psoriasis-related symptom assessments were included as part of the trials. Objective To assess the reliability, validity, and responsiveness of the patient reported outcome measures that were used in the trials – the Dermatology Life Quality Index (DLQI, the Psoriasis Symptom Assessment (PSA Scale, and two itch measures, a Visual Analog Scale (VAS and the National Psoriasis Foundation (NPF itch measure. Methods Subjects aged 18 to 70 years with moderate to severe psoriasis for at least 6 months were recruited into the two clinical trials (n = 1095. Internal consistency reliability was evaluated for all patient reported outcomes at baseline and at 12 weeks. Construct validity was evaluated by relations among the different patient reported outcomes and between the patient reported outcomes and the clinical assessments (Psoriasis Area and Severity Index; Overall Lesion Severity Scale; Physician's Global Assessment of Change assessed at baseline and at 12 weeks, as was the change over the course of the 12 week portion of the trial. Results Internal consistency reliability ranged from 0.86 to 0.95 for the patient reported outcome measures. The patient reported outcome measures were all shown to have significant construct validity with respect to each other and with respect to the clinical assessments. The four measures also demonstrated significant responsiveness to change in underlying clinical status of the patients over the course of the trial, as measured by the independently assessed clinical outcomes. Conclusions The DLQI, the PSA, VAS, and the NPF are considered useful tools for the measurement of dermatology

  18. Villitis of unknown aetiology: correlation of recurrence with clinical outcome.

    LENUS (Irish Health Repository)

    Feeley, L

    2010-01-01

    Villitis of unknown aetiology (VUA) is associated with adverse pregnancy outcome. Consequently, an ability to predict recurrence could be clinically relevant. We examined placentas where villitis was diagnosed in a previous pregnancy to establish the risk of recurrence and outcome. A total of 304 cases of VUA were diagnosed in our laboratory over a 4-year period. Subsequently, 19 of this cohort had a second placenta examined histologically. Recurrence and clinical outcome were recorded. Villitis recurred in 7 of 19 cases (37%). There was a high level of adverse pregnancy outcome in this cohort overall, characterised by small for gestational age infants and stillbirth, particularly in cases with high-grade villitis. We identified recurrent villitis more frequently than previously reported. Our findings confirm an association between high-grade villitis and poor outcome. Adequately powered prospective studies are required to determine if enhanced surveillance of subsequent pregnancies is indicated following a diagnosis of villitis.

  19. Levothyroxine Poisoning - Symptoms and Clinical Outcome

    DEFF Research Database (Denmark)

    Nygaard, Birgitte; Saedder, Eva A.; Dalhoff, Kim

    2015-01-01

    Levothyroxine (LT), T4, poisoning is rarely associated with a severe outcome. However, cases with significant complications have been reported. The aim of this study was to identify factors associated with symptoms of poisoning including late-onset symptoms. All enquiries to the Danish Poison...... Information Centre (DPIC) concerning LT poisoning between March 2007 and September 2012 were reviewed and the following parameters were recorded: age, dose, time from ingestion, multiple drug intake and symptoms. To evaluate the frequency of late-onset symptoms, a subgroup of patients without initial symptoms...... patients, neither in children nor in adults (age 16-92 years) (p symptoms of poisoning at the time of enquiry; however, in 9 of 21 (43%) patients, we were able to contact, late-onset symptoms existed. In none of the cases...

  20. Clinical Outcomes of Penile Prosthesis Implantation Surgery

    Directory of Open Access Journals (Sweden)

    Onur Dede

    2016-06-01

    Full Text Available Objective: We aimed to evaluating the outcomes of in­flatable penile prosthesis implantations and partner sat­isfaction. Methods: Data of 52 patients who underwent penile prosthesis implantation in single center between May 2010 and December 2015 were retrospectively analyzed. Types of prosthesis, complication and satisfaction rates of patients were recorded by EDITS (Erectile Dysfunction Inventory of Treatment Satisfaction questionnaire was used. Results: The mean age was 49.2±14.7 years for patients. The mean follow-up durations for 34.3±12.5 months. The mean hospital stay was 3.84±1.52 days. Evaluating of the couples satisfaction revealed that 44 (84% of the patient were very satisfied. There was not any complication and no patient need to underwent revision surgery. Conclusion: Inflatable penile prosthesis implants, with high levels of treatment success, patient and partner sat­isfaction, are effective and safe options for treatment of organic erectile dysfunction with acceptable complication and revision rates.

  1. Air Embolism: Diagnosis, Clinical Management and Outcomes

    Directory of Open Access Journals (Sweden)

    Colin J. McCarthy

    2017-01-01

    Full Text Available Air embolism is a rare but potentially fatal complication of surgical procedures. Rapid recognition and intervention is critical for reducing morbidity and mortality. We retrospectively characterized our experience with air embolism during medical procedures at a tertiary medical center. Electronic medical records were searched for all cases of air embolism over a 25-year period; relevant medical and imaging records were reviewed. Sixty-seven air embolism cases were identified; the mean age was 59 years (range, 3–89 years. Ninety-four percent occurred in-hospital, of which 77.8% were during an operation/invasive procedure. Vascular access-related procedures (33% were the most commonly associated with air embolism. Clinical signs and symptoms were related to the location the air embolus; 36 cases to the right heart/pulmonary artery, 21 to the cerebrum, and 10 were attributed to patent foramen ovale (PFO. Twenty-one percent of patients underwent hyperbaric oxygen therapy (HBOT, 7.5% aspiration of the air, and 63% had no sequelae. Mortality rate was 21%; 69% died within 48 hours. Thirteen patients had immediate cardiac arrest where mortality rate was 53.8%, compared to 13.5% (p = 0.0035 in those without. Air emboli were mainly iatrogenic, primarily associated with endovascular procedures. High clinical suspicion and early treatment are critical for survival.

  2. Measuring Mortality Information in Clinical Data Warehouses.

    Science.gov (United States)

    Jones, Barrett; Vawdrey, David K

    2015-01-01

    The ability to track and report long-term outcomes, especially mortality, is essential for advancing clinical research. The purpose of this study was to present a framework for assessing the quality of mortality information in clinical research databases. Using the clinical data warehouse (CDW) at Columbia University Medical Center as a case study, we measured: 1) agreement in vital status between our institution's patient registration system and the U.S. Social Security Administration's Death Master File (DMF), 2) the proportion of patients marked as deceased according to the DMF records who had subsequent visits to our institution, and 3) the proportion of patients still living according to Columbia's CDW who were over 100 and 120 years of age. Of 33,295 deaths recorded in our institution's patient registration system, 13,167 (39.5%) did not exist in the DMF. Of 315,037 patients in our CDW who marked as deceased according to the DMF, 2.1% had a subsequent clinical encounter at our institution. The proportion of patients still living according to Columbia's CDW who were over 100 and 120 years of age was 43.6% and 43.1%, respectively. These measures may be useful to other clinical research investigators seeking to assess the quality of mortality data (1-4).

  3. Fatigue is a reliable, sensitive and unique outcome measure in rheumatoid arthritis.

    LENUS (Irish Health Repository)

    Minnock, Patricia

    2009-12-01

    Fatigue is an important symptom in patients with RA. Measurement of fatigue in clinical trials and in clinical practice requires scales that are reproducible, sensitive to change and practical. This study examined the reliability and sensitivity to change of fatigue and its relative independence as an outcome measure in RA.

  4. Vision and vision-related outcome measures in multiple sclerosis.

    Science.gov (United States)

    Balcer, Laura J; Miller, David H; Reingold, Stephen C; Cohen, Jeffrey A

    2015-01-01

    Visual impairment is a key manifestation of multiple sclerosis. Acute optic neuritis is a common, often presenting manifestation, but visual deficits and structural loss of retinal axonal and neuronal integrity can occur even without a history of optic neuritis. Interest in vision in multiple sclerosis is growing, partially in response to the development of sensitive visual function tests, structural markers such as optical coherence tomography and magnetic resonance imaging, and quality of life measures that give clinical meaning to the structure-function correlations that are unique to the afferent visual pathway. Abnormal eye movements also are common in multiple sclerosis, but quantitative assessment methods that can be applied in practice and clinical trials are not readily available. We summarize here a comprehensive literature search and the discussion at a recent international meeting of investigators involved in the development and study of visual outcomes in multiple sclerosis, which had, as its overriding goals, to review the state of the field and identify areas for future research. We review data and principles to help us understand the importance of vision as a model for outcomes assessment in clinical practice and therapeutic trials in multiple sclerosis.

  5. CLINICAL PATTERN AND OUTCOME OF ORGANOPHOSPHORUS COMPOUND POISONING

    Directory of Open Access Journals (Sweden)

    Ranjith Kumar

    2016-06-01

    Full Text Available BACKGROUND Organophosphate insecticides/pesticides are used widely throughout the world. The organophosphorus poisoning is a very serious condition that needs rapid treatment. Emergent and appropriate management is always desirable to prevent the serious complications and high mortality. In this study, we determine the clinical presentation and outcome of organophosphorus poisoning in our institute. MATERIAL AND METHODS This study carried out in Medicine Department, SIMS, Shimoga, from January 1st, 2016 to April 20th 2016. A total of 100 cases of OP poisoning were studied. We included all patients of organophosphate poisoning presented either with signs of muscarinic involvement or signs of nicotinic involvement. Outcome measured according to W.H.O. classification of severity. RESULT Out of a total 100 patients of organophosphate poisoning were admitted, among these 44% were males and 56% females. Average age was 28.9±8.8 years. Nausea and vomiting was the most common clinical feature found in 93% of the patients followed by salivation seen in 91% and Miosis in 87%. According to W.H.O. Classification for Severity of Organophosphate poisoning. Mild 46%, 37% cases were moderate and 17% were severe. Overall mortality rate was 19%. CONCLUSION Present study shows the importance of WHO staging of severity of organophosphorus compound poisoning as mortality increases with severity. Study also showed that delayed arrival, lack of ICU facility and lack of preliminary management at the early stage are the causes of increased mortality in OP compound poisoning. OP compound poisoning needs rapid diagnosis, early and effective treatment to decrease the severity and mortality. These finding shows need for improvement in primary health care facility to decrease morbidity and mortality

  6. Clinical Outcome Metrics for Optimization of Robust Training

    Science.gov (United States)

    Ebert, D.; Byrne, V. E.; McGuire, K. M.; Hurst, V. W., IV; Kerstman, E. L.; Cole, R. W.; Sargsyan, A. E.; Garcia, K. M.; Reyes, D.; Young, M.

    2016-01-01

    Introduction: The emphasis of this research is on the Human Research Program (HRP) Exploration Medical Capability's (ExMC) "Risk of Unacceptable Health and Mission Outcomes Due to Limitations of In-Flight Medical Capabilities." Specifically, this project aims to contribute to the closure of gap ExMC 2.02: We do not know how the inclusion of a physician crew medical officer quantitatively impacts clinical outcomes during exploration missions. The experiments are specifically designed to address clinical outcome differences between physician and non-physician cohorts in both near-term and longer-term (mission impacting) outcomes. Methods: Medical simulations will systematically compare success of individual diagnostic and therapeutic procedure simulations performed by physician and non-physician crew medical officer (CMO) analogs using clearly defined short-term (individual procedure) outcome metrics. In the subsequent step of the project, the procedure simulation outcomes will be used as input to a modified version of the NASA Integrated Medical Model (IMM) to analyze the effect of the outcome (degree of success) of individual procedures (including successful, imperfectly performed, and failed procedures) on overall long-term clinical outcomes and the consequent mission impacts. The procedures to be simulated are endotracheal intubation, fundoscopic examination, kidney/urinary ultrasound, ultrasound-guided intravenous catheter insertion, and a differential diagnosis exercise. Multiple assessment techniques will be used, centered on medical procedure simulation studies occurring at 3, 6, and 12 months after initial training (as depicted in the following flow diagram of the experiment design). Discussion: Analysis of procedure outcomes in the physician and non-physician groups and their subsets (tested at different elapsed times post training) will allow the team to 1) define differences between physician and non-physician CMOs in terms of both procedure performance

  7. Capturing Psychologists' Work in Integrated Care: Measuring and Documenting Administrative Outcomes.

    Science.gov (United States)

    Kearney, Lisa K; Smith, Clifford A; Pomerantz, Andrew S

    2015-12-01

    With the expansion of integrated primary care and the increased focus on fiscal sustainability, it is critical for clinical managers of these innovative systems to have practical methods for measuring administrative outcomes. Administrative outcomes will assist leadership in the development of efficient, streamlined clinics to provide services to the primary care population. Additionally, administrative measures can be utilized to provide information to assist in guiding resource utilization and management decisions. Several administrative outcomes are suggested for integrated primary care managers to consider for application, including: clinic utilization measures, integrated care administrative measures, wait time and access metrics, and productivity monitors. Effective utilization of these measures can help office managers and clinic leadership not only to maximize patient care, but also to enhance essential business operations, which increase the long-term sustainability of integrated primary care programs.

  8. The gross motor function measure is a valid and sensitive outcome measure for spinal muscular atrophy.

    Science.gov (United States)

    Nelson, Leslie; Owens, Hollis; Hynan, Linda S; Iannaccone, Susan T

    2006-06-01

    Spinal muscular atrophy is a genetic disease of the anterior horn cell with high morbidity rate in childhood. Certain drugs may be of benefit and are in or under consideration for Phase II trials. Outcome measures that are age appropriate and representative of disease activity remain under study. Several have not yet been validated for spinal muscular atrophy. The Gross Motor Function Measure is a measure of motor function. We showed previously that the Gross Motor Function Measure is a reliable outcome measure to assess motor function in children with spinal muscular atrophy. By collating our data from 40 spinal muscular atrophy patients, ages 5 through 17 years, we now show the validity of the Gross Motor Function Measure when compared to Quantitative Muscle Testing and ambulatory status in children with spinal muscular atrophy. The median for Gross Motor Function Measure total scores for walkers was 237 (range: 197-261) and for non-walkers, 64 (range: 4-177; PGross Motor Function Measure is valid and sensitive as an outcome measure for clinical trials in pediatric spinal muscular atrophy.

  9. Pelvic Floor Disorders Registry: Study Design and Outcome Measures.

    Science.gov (United States)

    Weber LeBrun, Emily; Adam, Rony A; Barber, Matthew D; Boyles, Sarah Hamilton; Iglesia, Cheryl B; Lukacz, Emily S; Moalli, Pamela; Moen, Michael D; Richter, Holly E; Subak, Leslee L; Sung, Vivian W; Visco, Anthony G; Bradley, Catherine S

    2016-01-01

    Pelvic floor disorders affect up to 24% of adult women in the United States, and many patients with pelvic organ prolapse (POP) choose to undergo surgical repair to improve their quality of life. While a variety of surgical repair approaches and techniques are utilized, including mesh augmentation, there is limited comparative effectiveness and safety outcome data guiding best practice. In conjunction with device manufacturers, federal regulatory organizations, and professional societies, the American Urogynecologic Society developed the Pelvic Floor Disorders Registry (PFDR) designed to improve the quality of POP surgery by facilitating quality improvement and research on POP treatments. The PFDR will serve as a resource for surgeons interested in benchmarking and outcomes data and as a data repository for Food and Drug Administration-mandated POP surgical device studies. Provider-reported clinical data and patient-reported outcomes will be collected prospectively at baseline and for up to 3 years after treatment. All data elements including measures of success, adverse events, and surgeon characteristics were identified and defined within the context of the anticipated multifunctionality of the registry, and with collaboration from multiple stakeholders. The PFDR will provide a platform to collect high-quality, standardized patient-level data from a variety of nonsurgical (pessary) and surgical treatments of POP and other pelvic floor disorders. Data from this registry may be used to evaluate short- and longer-term treatment outcomes, patient-reported outcomes, and complications, as well as to identify factors associated with treatment success and failure with the overall goal of improving the quality of care for women with these conditions.

  10. Clinical outcomes of synthetic measures for preventing skin flap necrosis after mastectomy%防止乳腺癌术后皮瓣坏死措施的临床效果

    Institute of Scientific and Technical Information of China (English)

    徐志坚

    2009-01-01

    Objective To observe the outcomes of applying the synthetic measures for preventing skin flap necrosis after mastectomy. Methods The synthetic measures for preventing skin flap necrosis after mastectomy were applied in 98 patients (group A) undergoing modified radical mastectomy. The clinical outcomes were compared with those in 80 cases (group B) undergoing conventional modified radical rnastectomy. Results Skin flap necrosis in group A occurred in 2 cases (2. 0%), which was significantly lower than that in 15 cases (18. 6%) in group B (P<0.01). Subcutaneous dropsy in group A occurred in 3 cases (3. 1%),which was significantly lower than that in 27 cases (33.7%) in group B (P<0. 01). Conclusion The keys for preventing skin flap necrosis are selecting a reasonable thikness of skin flap, avoiding suture tension, preventing lymphoduct transudation, using effective drainage with two tubles and packing properly.%目的 探讨降低乳腺癌改良根治术后皮瓣坏死发生率的方法 .方法 对98例乳腺癌改良根治术患者(A组)采用了预防皮瓣坏死的综合措施,其结果 与以往实施的80例乳腺癌改良根治术病例(B组)进行比较.结果 B组皮瓣坏死15例(18.6%),皮下积液27例(33.7%).A组皮瓣坏死2例(2.0%).皮下积液3例(3.1%),均明显低于B组(P<0.01).结论 预防乳腺癌改良根治术后皮瓣坏死的关键是合理的皮瓣厚度,避免皮瓣缝合张力,防止淋巴管漏,有效双管引流和合适包扎.

  11. Implementation of a clinical pathway may improve alcohol treatment outcome

    DEFF Research Database (Denmark)

    Nielsen, Anette Søgaard; Nielsen, Bent

    2015-01-01

    or drinking no more than 21 standard drinks per week). Patients with harmful alcohol use or dependence as their primary problem who were seeking psychosocial treatment at one of four alcohol clinics in Denmark participated in the study. After implementation of the clinical pathway system, which incorporated...... a structured intake, a referral and independent follow-up system, checklists, audit, and feedback, there was no change in length of stay, but significantly more patients had a good clinical outcome (stopped or moderated their consumption) at the end of treatment (OR = 1.9; 1.2–3.1). The study documents...... the feasibility of using a clinical pathway framework, incorporating a local monitoring system, checklists, audit, and feedback to enhance treatment quality and improve outcomes for alcohol use disorders...

  12. Health outcome after major trauma: what are we measuring?

    Directory of Open Access Journals (Sweden)

    Karen Hoffman

    Full Text Available Trauma is a global disease and is among the leading causes of disability in the world. The importance of outcome beyond trauma survival has been recognised over the last decade. Despite this there is no internationally agreed approach for assessment of health outcome and rehabilitation of trauma patients.To systematically examine to what extent outcomes measures evaluate health outcomes in patients with major trauma.MEDLINE, EMBASE, and CINAHL (from 2006-2012 were searched for studies evaluating health outcome after traumatic injuries.Studies of adult patients with injuries involving at least two body areas or organ systems were included. Information on study design, outcome measures used, sample size and outcomes were extracted. The World Health Organisation International Classification of Function, Disability and Health (ICF were used to evaluate to what extent outcome measures captured health impacts.34 studies from 755 studies were included in the review. 38 outcome measures were identified. 21 outcome measures were used only once and only five were used in three or more studies. Only 6% of all possible health impacts were captured. Concepts related to activity and participation were the most represented but still only captured 12% of all possible concepts in this domain. Measures performed very poorly in capturing concepts related to body function (5%, functional activities (11% and environmental factors (2%.Outcome measures used in major trauma capture only a small proportion of health impacts. There is no inclusive classification for measuring disability or health outcome following trauma. The ICF may provide a useful framework for the development of a comprehensive health outcome measure for trauma care.

  13. Use of the extended therapy outcome measure for children with dysarthria.

    Science.gov (United States)

    Enderby, Pam

    2014-08-01

    Increasing demand on healthcare resources has led to a greater emphasis on the examination of the impact of service delivery on outcomes. Clinical assessments frequently do not cover all aspects of change associated with interventions for those with complex conditions. This paper reviews the need for more comprehensive outcome measurement suitable for clinical practice and benchmarking. It describes an extension of the Therapy Outcome Measure for specific use in reflecting the impact of the broad range of interventions commonly required when managing children with dysarthria. Three case histories are used to illustrate the approach, and data from four speech-language pathology services are used to illustrate the value of benchmarking.

  14. An empirical evaluation of multidimensional clinical outcome in chronic low back pain patients.

    Science.gov (United States)

    Klapow, J C; Slater, M A; Patterson, T L; Doctor, J N; Atkinson, J H; Garfin, S R

    1993-10-01

    Individuals with persisting pain often present a constellation of symptoms that includes pain, health-related impairment and dysphoric mood. It is now widely accepted that comprehensive assessment must address each of these dimensions. Despite recognition of the value of multidimensional assessment, no empirical efforts have validated the construct of a multidimensional clinical outcome presentation based on the dimensions of pain, impairment and dysphoric mood. We employed cluster analytic procedures on standard measures of pain, impairment and depression in chronic low back pain (CLBP) patients (n = 96) attending a general orthopedic clinic in order to empirically characterize multidimensional clinical outcomes. Results indicated that 3 groups could be identified reliably: (1) 'Chronic Pain Syndrome' (n = 25; high levels of pain, impairment and depression), (2) 'Positive Adaptation to Pain' (n = 24; high levels of pain with low levels of impairment and depression) and (3) 'Good Pain Control' (n = 47; low levels of pain, impairment and depression). The reliability of this cluster solution was supported by several tests of internal consistency. Discriminability of the clusters was examined across both the outcome measures themselves and several additional independent variables. The cluster solution was then cross-validated in an independent sample of pain clinic CLBP patients (n = 180) to test its generalizability. Finally the stability of the cluster dimensions over time was tested by re-assessing 36 CLBP patients 6 months after they initially were characterized into 1 of the 3 outcome groups on the same measures. MANOVA results indicated that the outcome groups were differentiated statistically across assessments. The multiple outcome measures did not change significantly across time, nor did the outcome groups change differentially across time on these measures. We conclude that the outcome dimensions of pain, impairment and depression are relatively stable

  15. Use of the measure your medical outcome profile (MYMOP2 and W-BQ12 (Well-Being outcomes measures to evaluate chiropractic treatment: an observational study

    Directory of Open Access Journals (Sweden)

    Polus Barbara I

    2011-03-01

    Full Text Available Abstract Background The objective was to assess the use of the Measure Yourself Medical Outcome Profile (MYMOP2 and W-BQ12 well-being questionnaire for measuring clinical change associated with a course of chiropractic treatment. Methods Chiropractic care of the patients involved spinal manipulative therapy (SMT, mechanically assisted techniques, soft tissue therapy, and physiological therapeutic devices. Outcome measures used were MYMOP2 and the Well-Being Questionnaire 12 (W-BQ12. Results Statistical and clinical significant changes were demonstrated with W-BQ12 and MYMOP2. Conclusions The study demonstrated that MYMOP2 was responsive to change and may be a useful instrument for assessing clinical changes among chiropractic patients who present with a variety of symptoms and clinical conditions.

  16. Stakeholders' views on measuring outcomes for people with learning disabilities.

    Science.gov (United States)

    Young, Anita F; Chesson, Rosemary A

    2006-01-01

    What works and how do we know? These are recurring questions for health and social care professionals, although mediated through differing philosophies and historical perspectives. The aims of the study reported here were to discover views of managers and commissioners of services for people with learning disabilities in Scotland regarding (a) current approaches to service evaluation (as an indication of what is to be measured) and (b) healthcare outcome measurement (as an indication of preferences regarding how this should be measured). A postal questionnaire was used to survey 94 stakeholders from the NHS, Local Authorities, and non-statutory organisations across Scotland. Respondents' views were sought on current approaches to service evaluation within learning disabilities; outcome measurement; appropriateness of specified methods of measuring health outcomes; desired future methods of outcome measurement within learning disabilities; and service user involvement in care. A 77% (73/94) response rate to the questionnaire was achieved. Different methods of service evaluation were used by different stakeholders. Staff appraisal was the most frequently identified method (used by 85% of respondents). Specific outcome measures were used by 32% of respondents although there were differences of opinion as to what constitutes specific outcome measures. Overall there was strong support for goal-setting and reviewing (83%) and individualised outcome measures (75%) as appropriate methods for use with people with learning disabilities. The hypothetical question asking what outcome measures should be introduced for this client group had by far the lowest response rate (51/73). The overwhelming majority of all respondents, 68 (92%), reported user involvement in their service. Staff ambivalence to outcome measurement was evident in the research and respondents highlighted the complexity and multidimensional nature of outcomes for this service user group. Managers recognised

  17. Sex differences in clinical characteristics and outcomes after myocardial infarction

    DEFF Research Database (Denmark)

    Lam, Carolyn S P; McEntegart, Margaret; Claggett, Brian;

    2015-01-01

    BACKGROUND: We examined the association of sex with clinical characteristics and outcomes in patients following myocardial infarction (MI) in the Valsartan in Acute Myocardial Infarction Trial (VALIANT). METHODS AND RESULTS: A total of 4570 women and 10 133 men with heart failure (HF), left ventr...

  18. Gene expression profiling predicts clinical outcome of breast cancer

    NARCIS (Netherlands)

    Veer, L.J. van 't; Dai, H.; Vijver, H. van de; He, Y.D.; Hart, A.A.M.; Mao, M.; Peterse, H.L.; Kooy, K. van der; Marton, M.J.; Witteveen, A.T.; Schreiber, G.J.; Kerkhoven, R.M.; Roberts, C.; Linsley, P.S.; Bernards, R.A.; Friend, S.H.

    2002-01-01

    Breast cancer patients with the same stage of disease can have markedly different treatment responses and overall outcome. The strongest predictors for metastases (for example, lymph node status and histological grade) fail to classify accurately breast tumours according to their clinical behaviour.

  19. Clinical outcomes of surgical management of anterior bilateral mandibular fractures

    NARCIS (Netherlands)

    Boffano, P.; Gallesio, C.; Roccia, F.; van den Bergh, B.; Forouzanfar, T.

    2013-01-01

    Purpose: The aims of this study were to assess the clinical outcomes of patients with anterior bifocal mandibular fractures and to discuss the management of this peculiar type of trauma. Methods: From the systematic computer-assisted database that has continuously recorded patients hospitalized with

  20. Quality management systems and clinical outcomes in Dutch nursing homes.

    NARCIS (Netherlands)

    Wagner, C.; Klein Ikkink, K.; Wal, G. van der; Spreeuwenberg, P.; Bakker, D.H. de; Groenewegen, P.P.

    2006-01-01

    The objective of the article is to explore the impact quality management systems and quality assurance activities in nursing homes have on clinical outcomes. The results are based on a cross-sectional study in 65 Dutch nursing homes. The management of the nursing homes as well as the residents (N =

  1. Quality management systems and clinical outcomes in Dutch nursing homes

    NARCIS (Netherlands)

    Wagner, Cordula; Klein Ikkink, Karen; Wal, Gerrit van der; Spreeuwenberg, Peter; Bakker, Dinny Herman de; Groenewegen, Peter Paulus

    2006-01-01

    The objective of the article is to explore the impact quality management systems and quality assurance activities in nursing homes have on clinical outcomes. The results are based on a cross-sectional study in 65 Dutch nursing homes. The management of the nursing homes as well as the residents (N= 1

  2. Serum magnesium levels and clinical outcome of aneurysmal subarachnoid hemorrhage: a study in 60 patients

    Directory of Open Access Journals (Sweden)

    Habibi Z

    2008-06-01

    Full Text Available Background: Hypomagnesemia is commonly encountered in patients with a wide variety of diseases including subarachnoid hemorrhage (SAH, cardiovascular emergencies, head trauma, migraine attacks, seizure and preeclampsia. It seems to be associated with a poor clinical outcome. This study considers the prevalence and temporal distribution of hypomagnesemia after aneurysmal SAH and its correlation with the severity of SAH, delayed cerebral ischemia (DCI as well as the neurological outcome after a period of three months.Methods: Between 2003 and 2008, 60 patients were admitted to the emergency ward of Imam Khomeini Hospital with acute SAH. Serum magnesium levels were measured during the first 72 hours, days 4-7, and second and third weeks after SAH. The three-month outcome was assessed according to the Glasgow Outcome Scale (GOS. Clinical SAH grading was performed according to the criteria of the World Federation of Neurological Surgeons (WFNS and the patients were allocated to "Good" (GOS = 4, 5 and "Poor" (GOS= 1-3 outcome groups. The prevalence of hypomagnesemia was assessed in both patient groups. Fisher exact test was used to analyze data.Results: Hypomagnesemia occurred in 22% of patients during the first 72 hours after SAH. It was associated with more prevalent DCI (p<0.05, whereas low serum magnesium levels during days 4-7 17% of patients and the second week (22% of patients after SAH were correlated with poor clinical outcome (p<0.05. No correlation was found between first 72 hour-hypomagnesemia and poor clinical outcome at three months.Conclusion: Hypomagnesemia occurs after aneurysmal SAH and it may predict the occurrence of DCI, while low serum magnesium levels during days 4-7 and within the second week of event predict poor clinical outcome at three months. Treatment of this electrolyte disturbance may have a favourable effect on the clinical outcome of patients with aneurysmal SAH.

  3. Personal Outcomes as Measures of Quality.

    Science.gov (United States)

    Gardner, James F.; Nudler, Sylvia; Chapman, Michael S.

    1997-01-01

    The Council on Quality and Leadership in Supports for People with Disabilities conducted interviews with 447 people with disabilities to identify priority outcomes they expect from service and supports. An analysis resulted in 24 variables loading onto 7 major factors: identity, autonomy, affiliation, attainment, rights, health, and safeguards.…

  4. Impact/outcome measures for libraries

    Directory of Open Access Journals (Sweden)

    Roswitha Poll

    2003-12-01

    Full Text Available Libraries today document their performance for the most part only in data of input and output (e.g. size of the collection, number of issues, of reference answers etc.. If they do more, they evaluate the quality and user-orientation of their services by applying performance indicators or user satisfaction surveys. Data of high use or high user satisfaction seem to indicate that users benefit from the library's services. But in demonstrating the library's value to the financing authorities or the public it would be much more effective if libraries could show a direct impact/outcome of their services on their users. Such outcome might be either a monetary value attributed to one case of use, or the impact on the users' skills and knowledge, their information literacy. Quite a number of projects in different countries have tested methods to catch this 'outcome'. They have tried to assess the value assigned by the population to certain library services, to find a connection between success in studies or research and library use, to assess the library's impact on students' information literacy, to explore the information behaviour of groups in order to specify the library's role in information research and information delivery. The paper describes the different starting points for assessing outcome of library services.

  5. [Outcomes count: the importance of measuring the outcomes of hospital care].

    Science.gov (United States)

    Sangha, Oliver; Schneeweiss, Sebastian

    2002-01-01

    A century ago the Boston surgeon Earnest A. Codman described in detail the requirements for monitoring quality of care and emphasized the importance of outcomes in evaluating care. At the time the medical societies were disconcerted by his ideas, which were perceived as revolutionary. After several decade of focusing on the structures and processes of care we are now witnessing a renaissance of measuring outcomes. This paper emphasizes the need for outcomes measurement monitor quality of care. The introduction of diagnosis-related groups in Germany is the most recent development that underlines the importance of outcomes measurement and benchmarking.

  6. Quality and consistency of outcome reporting in clinical trials of immunosuppression in renal transplantation.

    Science.gov (United States)

    Hussain, Samia; Knight, Simon R

    2016-11-01

    Interpretation, comparison, and combination of results of clinical trials are reliant on accurate and complete reporting of outcomes. This study aimed to assess the quality and variability in outcome reporting in immunosuppression trials following renal transplantation. All randomized controlled trials comparing immunosuppressive interventions in renal transplant recipients published over a 5-year period were included. Outcomes reported in these studies were extracted, along with data regarding completeness of reporting and whether a clear definition of the method used to measure the outcome was provided. A total of 4760 outcomes were identified from 182 studies. Overall, 90.3% outcomes were completely reported; the remainder had missing data that would preclude use in meta-analysis; 31.5% manuscripts did not define a primary endpoint. Efficacy outcomes were more likely to be clearly defined than safety outcomes (OR: 0.022, P<.001) or patient-reported outcome measures (PROMs) (OR: 0.014, P<.001). PROMs were reported in less than half of manuscripts, and only five reported quality-of-life data using a validated tool. There was significant variability in the way that common efficacy and safety outcomes were defined. Variability in the way that endpoints are selected and reported in trials in renal transplantation makes interpretation and comparison between studies difficult.

  7. Campus Clinical: simulation-based curriculum designed to meet clinical course learning outcomes.

    Science.gov (United States)

    Jarvis, Michelle; Rivers, Julie

    2014-01-01

    Campus Clinical is a simulation-based curriculum designed to meet the challenge of decreasing clinical spaces in maternal-child units. The curriculum framework is situated in a constructivist, experiential learning context, integrating Chickering and Gamson's principles for good practice in education. This innovative approach to meeting clinical course learning outcomes is transferable to a variety of settings.

  8. Practical considerations for the implementation of health outcome measures.

    Science.gov (United States)

    Carriere, Robin S

    2009-01-01

    The collection of health outcomes information is important for effective management of the health care system. The Health Outcomes for Better Information and Care (HOBIC) program is implementing a set of nurse-sensitive health outcome measures across the province of Ontario. This paper examines some of the opportunities and challenges of implementing measures across multiple organizations and multiple sectors of the health care system.

  9. Coronary Stents: The Impact of Technological Advances on Clinical Outcomes.

    Science.gov (United States)

    Mennuni, Marco G; Pagnotta, Paolo A; Stefanini, Giulio G

    2016-02-01

    Percutaneous coronary interventions (PCI) were proposed in the late 1970s as an alternative to surgical coronary artery bypass grafting for the treatment of coronary artery disease. Important technological progress has been made since. Balloon angioplasty was replaced by bare metal stents, which allowed to permanently scaffold the coronary vessel avoiding acute recoil and abrupt occlusion. Thereafter, the introduction of early generation drug-eluting stents (DES) has significantly improved clinical outcomes, primarily by markedly reducing the risk of restenosis. New generation DES with thinner stent struts, novel durable or biodegradable polymer coatings, and new limus antiproliferative agents, have further improved upon the safety and efficacy profile of early generation DES. The present article aims to review the impact of technological advances on clinical outcomes in the field of PCI with coronary stents, and to provide a brief overview on clinical margins of improvement and unmet needs of available DES.

  10. Outcome measures for primary Sjögren's syndrome.

    Science.gov (United States)

    Seror, Raphaèle; Bootsma, Hendrika; Bowman, Simon J; Dörner, Thomas; Gottenberg, Jacques-Eric; Mariette, Xavier; Ramos-Casals, Manel; Ravaud, Philippe; Theander, Elke; Tzioufas, Athanasios; Vitali, Claudio

    2012-08-01

    Lymphocytic infiltration of different exocrine and non-exocrine epithelia is the pathological hallmark of primary Sjögren's syndrome, whereas involvement of salivary and lachrymal glands with the clinical counterpart of dry eye and dry mouth are the predominant features of the disease, together with fatigue and musculoskeletal pain. In addition, systemic manifestations, like arthritis, skin vasculitis, peripheral neuropathy, glomerulonephritis, may also be present in a consistent number of patients. As result, clinical features in SS can be divided into two facets: the benign subjective but disabling manifestations such as dryness, pain and fatigue, and the systemic manifestations. In the past decades, a core set of domains, which included sicca symptoms, objective measurements of tear and saliva production, fatigue, quality of life, disease activity and damage was indicated as essential for outcome assessment in this disorder. Afterwards, great efforts have been made to develop valid tools for the assessment of different domains. Specific questionnaires such as the Profile of Fatigue and Discomfort (PROFAD) and Sicca Symptoms Inventory (SSI) have been proposed as dedicated tools for the evaluation of patients symptoms, whereas different composite indexes have been suggested for the assessment of disease activity and damage. Some of these preliminary studies served as bases of an international project supported by EULAR, aimed at developing two consensus disease activity indexes: the EULAR Sjögren's Syndrome Patients Reported Index (ESSPRI), and the EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI), a systemic activity index to assess systemic manifestations. A detailed and critical review of all these indexes is provided in this article. Both EULAR indexes showed, in recent studies, to be feasible, valid, and reliable instruments. After their final validation, which is currently in process, they could be used as consensus outcome criteria in therapeutic

  11. Measuring outcomes of communication partner training of health care professionals:

    DEFF Research Database (Denmark)

    Isaksen, Jytte; Jensen, Lise Randrup

    Background: People with aphasia have greater risks of experiencing adverse events or medical errors in health care settings [1, 2]. Furthermore, people with aphasia often depend crucially on health care professionals’ ability to support their participation in information sharing, decisions about...... health care, and other communicative exchanges associated with appropriate health care [3]. As a consequence of these challenges in patient-provider communication, implementation of evidence- based methods of communication partner training is becoming increasingly frequent in different health care...... different needs? Implications for clinical practice: There is a need to develop different types of outcome measures for communication partner training in the health care context, including questionnaires for health care staff, which address generally agreed-upon problem areas in patient-provider...

  12. Predictable Outcomes with Porcelain Laminate Veneers: A Clinical Report.

    Science.gov (United States)

    Pimentel, Welson; Teixeira, Marcelo Lucchesi; Costa, Priscila Paganini; Jorge, Mônica Zacharias; Tiossi, Rodrigo

    2016-06-01

    This clinical report describes how to achieve predictable outcomes for anterior teeth esthetic restorations with porcelain laminate veneers by associating the digital planning and design of the restoration with interim restorations. The previous digital smile design of the restoration eliminates the communication barrier with the patient and assists the clinician throughout patient treatment. Interim restorations (diagnostic mock-ups) further enhance communication with the patient and prevent unnecessary tooth reduction for conservative tooth preparation. Adequate communication between patient and clinician contributes to successful definitive restorations and patient satisfaction with the final esthetic outcome.

  13. The COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN and how to select an outcome measurement instrument

    Directory of Open Access Journals (Sweden)

    Lidwine B. Mokkink

    2016-01-01

    Full Text Available Background: COSMIN (COnsensus-based Standards for the selection of health Measurement INstruments is an initiative of an international multidisciplinary team of researchers who aim to improve the selection of outcome measurement instruments both in research and in clinical practice by developing tools for selecting the most appropriate available instrument. Method: In this paper these tools are described, i.e. the COSMIN taxonomy and definition of measurement properties; the COSMIN checklist to evaluate the methodological quality of studies on measurement properties; a search filter for finding studies on measurement properties; a protocol for systematic reviews of outcome measurement instruments; a database of systematic reviews of outcome measurement instruments; and a guideline for selecting outcome measurement instruments for Core Outcome Sets in clinical trials. Currently, we are updating the COSMIN checklist, particularly the standards for content validity studies. Also new standards for studies using Item Response Theory methods will be developed. Additionally, in the future we want to develop standards for studies on the quality of non-patient reported outcome measures, such as clinician-reported outcomes and performance-based outcomes. Conclusions: In summary, we plea for more standardization in the use of outcome measurement instruments, for conducting high quality systematic reviews on measurement instruments in which the best available outcome measurement instrument is recommended, and for stopping the use of poor outcome measurement instruments.

  14. Does crossover innervation really affect the clinical outcome? A comparison of outcome between unilateral and bilateral digital nerve repair.

    Science.gov (United States)

    Oruç, Melike; Ozer, Kadri; Çolak, Özlem; Kankaya, Yüksel; Koçer, Uğur

    2016-09-01

    Digital nerve injuries are the mostly detected nerve injury in the upper extremity. However, since the clinical phenomenon of crossover innervation at some degree from uninjured digital nerve to the injured side occurs after digital nerve injuries is sustained, one could argue that this concept might even result in the overestimation of the outcome of the digital nerve repair. With this knowledge in mind, this study aimed to present novel, pure, focused and valuable clinical data by comparing the outcomes of bilateral and unilateral digital nerve repair. A retrospective review of 28 fingers with unilateral or bilateral digital nerve repair using end-to-end technique in 19 patients within 2 years was performed. Weber's two-point discrimination, sharp/dull discrimination, warm/cold sensation and Visual Analog Scale scoring were measured at final 12-month follow ups in all patients. There was no significant difference in recovery of sensibility after unilateral and bilateral digital nerve repairs. Though there is crossover innervation microscopically, it is not important in the clinical evaluation period. According to clinical findings from this study, crossover innervations appear to be negligible in the estimation of outcomes of digital neurorrhaphy.

  15. Does crossover innervation really affect the clinical outcome? A comparison of outcome between unilateral and bilateral digital nerve repair

    Institute of Scientific and Technical Information of China (English)

    Melike Oru; Kadri Ozer; zlem olak; Yksel Kankaya; Uur Koer

    2016-01-01

    Digital nerve injuries are the mostly detected nerve injury in the upper extremity. However, since the clinical phenomenon of crossover innervation at some degree from uninjured digital nerve to the in-jured side occurs after digital nerve injuries is sustained, one could argue that this concept might even result in the overestimation of the outcome of the digital nerve repair. With this knowledge in mind, this study aimed to present novel, pure, focused and valuable clinical data by comparing the outcomes of bilateral and unilateral digital nerve repair. A retrospective review of 28 ifngers with unilateral or bilateral digital nerve repair using end-to-end technique in 19 patients within 2 years was performed. Weber’s two-point discrimination, sharp/dull discrimination, warm/cold sensation and Visual Analog Scale scoring were measured at final 12-month follow ups in all patients. There was no significant difference in recovery of sensibility after unilateral and bilateral digital nerve repairs. Though there is crossover innervation microscopically, it is not important in the clinical evaluation period. According to clinical ifndings from this study, crossover innervations appear to be negligible in the estimation of outcomes of digital neurorrhaphy.

  16. SEIZURE SEVERITY AS AN ALTERNATIVE MEASURE OF OUTCOME IN EPILEPSY

    Directory of Open Access Journals (Sweden)

    Koraliya S. Todorova

    2013-07-01

    Full Text Available Seizure severity emerges as an important aspect of epilepsy. This is most relevant in refractory patients in whom complete remission of seizures is unlikely and reduced seizure severity may be a significant determinant of psychosocial well-being with a consequent improvement in quality of life (QOL. Thus a valid measure of seizure severity can serve both as an indicator of clinical outcome and as an evaluation tool of the interaction between seizures and the psychosocial complications of epilepsy.After a brief review of the most frequently used scales measuring seizure severity in adults with epilepsy we have explored the relationship between seizure severity and QOL in a set of 103 patients. Two self-evaluation questionnaires were applied: the Seizure Severity Questionnaire (SSQ and the Quality of Life in Epilepsy Inventory (QOLIE-31. The severity of the coexisting depression, an important confounder in the relationship between seizure severity and QOL, was assessed by the Hamilton Depression Rating Scale (HAMD-17.All domains of the Quality-of-Life in Epilepsy Inventory (QOLIE-31 correlated highly significantly with seizure severity (p≤0.01. The correlation was strong for the Overall score (r=-0.70; p≤0.001 and the Seizure worry domain (r=-0.71; p≤0.001. When the potentially confounding effect of depression was controlled for, the regression of seizure severity with the QOLIE-31 Overall score (P=0.001; R²=0.56 and the Seizure worry domain (P=0.001; R²=0.50 remained significant. These findings indicate that seizure severity is strongly associated with QOL in epilepsy and could be used as an alternative indicator of outcome in clinical research.

  17. Correlations between outcomes of random measurements

    Science.gov (United States)

    Tran, Minh Cong; Dakić, Borivoje; Laskowski, Wiesław; Paterek, Tomasz

    2016-10-01

    We recently showed that multipartite correlations between outcomes of random observables detect quantum entanglement in all pure and some mixed states. In this followup article we further develop this approach, derive a maximal amount of such correlations, and show that they are not monotonous under local operations and classical communication. Nevertheless, we demonstrate their usefulness in entanglement detection with a single random observable per party. Finally we study convex-roof extension of the correlations and provide a closed-form necessary and sufficient condition for entanglement in rank-2 mixed states and a witness in general.

  18. Molecular Subtypes of Uterine Leiomyosarcoma and Correlation with Clinical Outcome

    Directory of Open Access Journals (Sweden)

    Joyce N. Barlin

    2015-02-01

    Full Text Available The molecular etiology of uterine leiomyosarcoma (ULMS is poorly understood, which accounts for the wide disparity in outcomes among women with this disease. We examined and compared the molecular profiles of ULMS and normal myometrium (NL to identify clinically relevant molecular subtypes. Discovery cases included 29 NL and 23 ULMS specimens. RNA was hybridized to Affymetrix U133A 2.0 transcription microarrays. Differentially expressed genes and pathways were identified using standard methods. Fourteen NL and 44 ULMS independent archival samples were used for external validation. Molecular subgroups were correlated with clinical outcome. Pathway analyses of differentially expressed genes between ULMS and NL samples identified overrepresentation of cell cycle regulation, DNA repair, and genomic integrity. External validation confirmed differential expression in 31 genes (P < 4.4 × 10−4, Bonferroni corrected, with 84% of the overexpressed genes, including CDC7, CDC20, GTSE1, CCNA2, CCNB1, and CCNB2, participating in cell cycle regulation. Unsupervised clustering of ULMS identified two clades that were reproducibly associated with progression-free (median, 4.0 vs 26.0 months; P = .02; HR, 0.33 and overall (median, 18.2 vs 77.2 months; P = .04; HR, 0.33 survival. Cell cycle genes play a key role in ULMS sarcomagenesis, providing opportunities for therapeutic targeting. Reproducible molecular subtypes associated with clinical outcome may permit individualized adjuvant treatment after clinical trial validation.

  19. Outcome measures for primary Sjogren's syndrome

    NARCIS (Netherlands)

    Seror, Raphaele; Bootsma, Hendrika; Bowman, Simon J.; Doerner, Thomas; Gottenberg, Jacques-Eric; Mariette, Xavier; Ramos-Casals, Manel; Ravaud, Philippe; Theander, Elke; Tzioufas, Athanasios; Vitali, Claudio

    2012-01-01

    Lymphocytic infiltration of different exocrine and non-exocrine epithelia is the pathological hallmark of primary Sjogren's syndrome, whereas involvement of salivary and lachrymal glands with the clinical counterpart of dry eye and dry mouth are the predominant features of the disease, together with

  20. Pneumothorax following Endobronchial Valve Therapy and Its Impact on Clinical Outcomes in Severe Emphysema

    NARCIS (Netherlands)

    Gompelmann, Daniela; Herth, Felix J. F.; Slebos, Dirk Jan; Valipour, Arschang; Ernst, Armin; Criner, Gerard J.; Eberhardt, Ralf

    2014-01-01

    Background: Patients who achieve significant target lobe volume reduction (TLVR) following endobronchial valve (EBV) treatment may experience substantial improvements in clinical outcome measures. However, in cases of rapid TLVR, the risk of pneumothorax increases due to parenchymal rupture of the a

  1. Survival and clinical outcome of dogs with ischaemic stroke

    DEFF Research Database (Denmark)

    Gredal, Hanne Birgit; Toft, Nils; Westrup, Ulrik

    2013-01-01

    The objectives of the present study were to investigate survival time, possible predictors of survival and clinical outcome in dogs with ischaemic stroke. A retrospective study of dogs with a previous diagnosis of ischaemic stroke diagnosed by magnetic resonance imaging (MRI) was performed....... The association between survival and the hypothesised risk factors was examined using univariable exact logistic regression. Survival was examined using Kaplan-Meier and Cox regression. Twenty-two dogs were identified. Five dogs (23%) died within the first 30days of the stroke event. Median survival in 30-day...... survivors was 505days. Four dogs (18%) were still alive by the end of the study. Right-sided lesions posed a significantly increased risk of mortality with a median survival time in dogs with right-sided lesions of 24days vs. 602days in dogs with left sided lesions (P=0.006). Clinical outcome was considered...

  2. Clinical Manifestations and Outcomes of West Nile Virus Infection

    Directory of Open Access Journals (Sweden)

    James J. Sejvar

    2014-02-01

    Full Text Available Since the emergence of West Nile virus (WNV in North America in 1999, understanding of the clinical features, spectrum of illness and eventual functional outcomes of human illness has increased tremendously. Most human infections with WNV remain clinically silent. Among those persons developing symptomatic illness, most develop a self-limited febrile illness. More severe illness with WNV (West Nile neuroinvasive disease, WNND is manifested as meningitis, encephalitis or an acute anterior (polio myelitis. These manifestations are generally more prevalent in older persons or those with immunosuppression. In the future, a more thorough understanding of the long-term physical, cognitive and functional outcomes of persons recovering from WNV illness will be important in understanding the overall illness burden.

  3. Clinical and Functional Outcomes of the Birmingham Hip Resurfacing System.

    Science.gov (United States)

    Pascual-Garrido, Cecilia; Morris, Brandon L; Dayton, Michael R

    2016-01-01

    This study reported the outcomes of patients treated with the Birmingham Hip Resurfacing System (Smith & Nephew, Memphis, Tennessee) to identify the prevalence of complications and failures. A retrospective review of 202 patients (206 hips) was performed. Outcomes were assessed clinically with Harris Hip Score at 6 and 12 months and then yearly. Subanalysis was performed, with the hips divided according to patient sex and size of the femoral component. Mean patient age was 51±8 years, and mean follow-up was 4±1.6 years. Of the patients, 163 were men (83%) and 35 were women (17%). Postoperative improvement was significant, with preoperative Harris Hip Score of 62.9±10.6 and postoperative Harris Hip Score of 98.6±6.7 (Phips (2.4%) underwent revision. At 3 years, mean survival was better for men than for women (99% vs 92%, respectively). Survival was lowest in patients with femoral component diameter of less than 46 mm. According to the authors' results, the Birmingham Hip Resurfacing System resulted in good clinical outcomes at 4 years. Survival and outcomes in women, particularly those with modest bone size, are inferior.

  4. Intracranial tuberculosis in children: CT appearance and clinical outcome

    Energy Technology Data Exchange (ETDEWEB)

    Wallace, R.C.; Burton, E.M.; Gerald, B.E. (Le Bonheur Children' s Medical Center, Memphis, TN (United States). Dept. of Radiology Tennessee Univ., Memphis (United States)); Barrett, F.F.; Leggiadro, R.J. (Le Bonheur Children' s Medical Center, Memphis, TN (United States). Dept. of Pediatrics Tennessee Univ., Memphis (United States)); Lasater, O.E. (Le Bonheur Children' s Medical Center, Memphis, TN (United States). Dept. of Pathology Tennessee Univ., Memphis (United States))

    1991-05-01

    We retrospectively evaluated the CT studies of 9 children who presented with intracranial tuberculosis during 1981-1987, and compared their radiographic appearance with the clinical outcome. The most common radiographic findings were: 1) Ventriculomegaly (7/9), 2) tuberculoma formation (6/9), and 3) infarction (4/9). Of 7 patients with ventriculomegaly, 3 required a ventricular shunt and 2 had spontaenous resolution of ventricular dilatation. Four children with ventriculomegaly were moderately or severely retarded, one had cognitive dysfunction, and one was neurologically normal. Four of six children with tuberculoma also had infarction and/or ventriculomegaly; of these four children, three were moderately or severely retarded. Two patients with tuberculoma as the only intracranial abnormality had complete resolution or the granuloma with normal neurologic outcome following antituberculous therapy. The four children with large vessel infarction also had ventriculomegaly; three had poor clinical outcome. The presence of tuberculoma alone is not necessarily predictive of poor neurologic outcome; age less than 20 months, infarct, and/or ventriculomegaly are usually associated with sequelae. (orig.).

  5. Clinical profile and outcome of posterior reversible encephalopathy syndrome (PRES)

    OpenAIRE

    Patil, Virendra C.; Vaibhav Agrwal; Amardip Rajput; Rishu Garg; Ketan Kshirsagar; Vinit Chaudhari

    2015-01-01

    Background: Posterior reversible encephalopathy syndrome (PRES) is a clinico-radiographic syndrome of multiple etiologies. Still, the exact pathophysiology of PRES is not clear. Aims and Objectives: To study demographic, etiological, and clinic-radiological profiles of patients presenting with PRES and their outcome at the tertiary care teaching hospital. Materials and Methods: A retrospective observational and non-interventional study was conducted at tertiary care center in from January 200...

  6. Impact of clinical pathway on clinical outcomes in the management of COPD exacerbation

    Directory of Open Access Journals (Sweden)

    Ban Andrea

    2012-06-01

    Full Text Available Abstract Background Exacerbations, a leading cause of hospitalization in patients with chronic obstructive pulmonary disease (COPD, affect the quality of life and prognosis. Treatment recommendations as provided in the evidence-based guidelines are not consistently followed, partly due to absence of simplified task-oriented approach to care. In this study, we describe the development and implementation of a clinical pathway (CP and evaluate its effectiveness in the management of COPD exacerbation. Methods We developed a CP and evaluated its effectiveness in a non-randomized prospective study with historical controls on patients admitted for exacerbation of COPD to Universiti Kebangsaan Malaysia Medical Centre (UKMMC. Consecutive patients who were admitted between June 2009 and December 2010 were prospectively recruited into the CP group. Non-CP historical controls were obtained from case records of patients admitted between January 2008 and January 2009. Clinical outcomes were evaluated by comparing the length of stay (LOS, complication rates, readmissions, and mortality rates. Results Ninety-five patients were recruited in the CP group and 98 patients were included in the non-CP historical group. Both groups were comparable with no significant differences in age, sex and severity of COPD (p = 0.641. For clinical outcome measures, patients in the CP group had shorter length of stay than the non-CP group (median (IQR: 5 (4–7 days versus 7 (7–9 days, p p  Conclusion The implementation of CP –reduced the length of stay and complication rates of patients hospitalized for acute exacerbation of COPD.

  7. Assurance calculations for planning clinical trials with time-to-event outcomes.

    Science.gov (United States)

    Ren, Shijie; Oakley, Jeremy E

    2014-01-15

    We consider the use of the assurance method in clinical trial planning. In the assurance method, which is an alternative to a power calculation, we calculate the probability of a clinical trial resulting in a successful outcome, via eliciting a prior probability distribution about the relevant treatment effect. This is typically a hybrid Bayesian-frequentist procedure, in that it is usually assumed that the trial data will be analysed using a frequentist hypothesis test, so that the prior distribution is only used to calculate the probability of observing the desired outcome in the frequentist test. We argue that assessing the probability of a successful clinical trial is a useful part of the trial planning process. We develop assurance methods to accommodate survival outcome measures, assuming both parametric and nonparametric models. We also develop prior elicitation procedures for each survival model so that the assurance calculations can be performed more easily and reliably. We have made free software available for implementing our methods.

  8. The role of clinical pathway on the outcomes of ischemic stroke patients at Bethesda Hospital Yogyakarta

    Directory of Open Access Journals (Sweden)

    Francisca Diana Alexandra, Iwan Dwiprahasto, Rizaldy Pinzon

    2014-04-01

    Full Text Available Stroke becomes world health problem all over the world because it is the causal factor of high mortality and disability. Good and well-organized process of healthcare service will improve the outcome of the patients with stroke. Clinical pathway may be used as clear standard to help reduce unnecessary variations of medical treatment and measure. The study aimed at finding out the correlation between the use of clinical pathway and the outcome of the patients with ischemic stroke in Bethesda Hospital Yogyakarta. It was an observational and analytic study with cohort restorative study design. The author compared the outcomes of acute ischemic stroke between the group with clinical pathway and the group without the clinical pathway. Data was collected using consecutive sampling from the electronic registry and medical record data of the patients from January 1st, 2011 to December 31st, 2011. It was conducted to 124 patients with ischemic stroke assigned to two groups (the first groups of 62 patients with clinical pathway and the second groups of 62 patients without clinical pathway. The basic characteristics of the two groups were the same. The results of the analysis showed that there was a significant decrease in the incidence of complication and a significant increase in the use of antiplatelete drugs, antidiabetic drugs and statin as secondary preventive measure of the recurrent stroke. There was not any significant difference in the duration of the hospitalized healthcare, the financing and the mortality between the two observation groups. The study indicated that the use of the clinical pathway in the stroke treatment improved the outcome of the patients with stroke. It was necessary to conduct further study to evaluate the effectiveness of the clinical pathway in improving the outcome of the patients with bigger number of the subjects and the longer period of time.

  9. Myasthenia gravis and pregnancy: clinical implications and neonatal outcome

    Directory of Open Access Journals (Sweden)

    Estanol Bruno

    2004-11-01

    Full Text Available Abstract Background The myasthenia gravis is twice as common in women as in men and frequently affects young women in the second and third decades of life, overlapping with the childbearing years. Generally, during pregnancy in one third of patients the disease exacerbates, whereas in two thirds it remains clinically unchanged. Complete remission can occur in some patients. Methods To describe the clinical course, delivery and neonatal outcome of 18 pregnant women with the diagnosis of myasthenia gravis. Retrospective chart review of pregnant patients with myasthenia gravis, followed at the National Institute of Perinatology in Mexico City over an 8-year period. Data was abstracted from the medical records on the clinical course during pregnancy, delivery and neonatal outcome. Results From January 1, 1996 to December 31, 2003 18 patients with myasthenia gravis were identified and included in the study. The mean ± SD maternal age was 27.4 ± 4.0 years. During pregnancy 2 women (11% had an improvement in the clinical symptoms of myasthenia gravis, 7 women (39% had clinical worsening of the condition of 9 other patients (50% remained clinically unchanged. Nine patients delivered vaginally, 8 delivered by cesarean section and 1 pregnancy ended in fetal loss. Seventeen infants were born at mean ± SD gestational age of 37.5 ± 3.0 weeks and a mean birth weight of 2710 ± 73 g. Only one infant presented with transient neonatal myasthenia gravis. No congenital anomalies were identified in any of the newborns. Conclusions The clinical course of myasthenia gravis during pregnancy is variable, with a significant proportion of patients experiencing worsening of the clinical symptoms. However, neonatal transient myasthenia was uncommon in our patient population.

  10. Renal Involvement in AA Amyloidosis: Clinical Outcomes and Survival

    Directory of Open Access Journals (Sweden)

    Murvet Yilmaz

    2013-03-01

    Full Text Available Background: The natural history of AA amyloidosis is typically progressive, leading to multiple organ failure and death. We analyzed the etiology as well as clinical and laboratory features of patients with biopsy-proven AA amyloidosis and evaluated the ultimate outcome. Methods: Seventy-three patients (24 female; mean age 41.85±15.89 years were analyzed retrospectively. Demographic, clinical and laboratory features were studied and the outcome was assessed. Results: Familial Mediterranean Fever and tuberculosis were the most frequent causes of amyloidosis. Mean serum creatinine and proteinuria at diagnosis were 4.65±4.89 mg/dl and 8.04±6.09 g/day, respectively; and stage I, II, III, IV and V renal disease were present in 19.2%, 13.7%, 16.4%, 11%, and 39.7% of the patients, respectively. ESRD developed in 16 patients during the follow-up period. All of the ESRD patients started a dialysis programme. Thirty patients (41% died during the follow-up period; median patient survival was 35.9±6.12 months. Old age, tuberculosis etiology, advanced renal disease and low serum albumin levels were associated with a worse prognosis. Serum albumin was a predictor of mortality in logistic regression analysis. Conclusion: The ultimate outcome of the patients with AA amyloidosis is poor, possibly due to the late referral to the nephrology clinics. Early referral may be helpful to improve prognosis.

  11. Development and evaluation of an Individualized Outcome Measure (IOM) for randomized controlled trials in mental health.

    Science.gov (United States)

    Pesola, Francesca; Williams, Julie; Bird, Victoria; Freidl, Marion; Le Boutillier, Clair; Leamy, Mary; Macpherson, Rob; Slade, Mike

    2015-12-01

    Pre-defined, researcher-selected outcomes are routinely used as the clinical end-point in randomized controlled trials (RCTs); however, individualized approaches may be an effective way to assess outcome in mental health research. The present study describes the development and evaluation of the Individualized Outcome Measure (IOM), which is a patient-specific outcome measure to be used for RCTs of complex interventions. IOM was developed using a narrative review, expert consultation and piloting with mental health service users (n = 20). The final version of IOM comprises two components: Goal Attainment (GA) and Personalized Primary Outcome (PPO). For GA, patients identify one relevant goal at baseline and rate its attainment at follow-up. For PPO, patients choose an outcome domain related to their goal from a pre-defined list at baseline, and complete a standardized questionnaire assessing the chosen outcome domain at baseline and follow-up. A feasibility study indicated that IOM had adequate completion (89%) and acceptability (96%) rates in a clinical sample (n = 84). IOM was then evaluated in a RCT (ISRCTN02507940). GA and PPO components were associated with each other and with the trial primary outcome. The use of the PPO component of IOM as the primary outcome could be considered in future RCTs. Copyright © 2015 John Wiley & Sons, Ltd.

  12. Predicting Future Clinical Adjustment from Treatment Outcome and Process Variables.

    Science.gov (United States)

    Patterson, G. R.; Forgatch, Marion S.

    1995-01-01

    Issues related to the use of outcome and process data from the treatment of antisocial children to predict future childhood adjustment were examined through a study of 69 children. Data supported the hypothesis that measures of processes thought to produce changes in child behavior would serve to predict future adjustment. (SLD)

  13. Improving Treatment Trial Outcomes for Rett Syndrome: The Development of Rett-specific Anchors for the Clinical Global Impression Scale.

    Science.gov (United States)

    Neul, Jeffrey L; Glaze, Daniel G; Percy, Alan K; Feyma, Tim; Beisang, Arthur; Dinh, Thuy; Suter, Bernhard; Anagnostou, Evdokia; Snape, Mike; Horrigan, Joseph; Jones, Nancy E

    2015-11-01

    Rett syndrome is a genetically based neurodevelopmental disorder. Although the clinical consequences of Rett syndrome are profound and lifelong, currently no approved drug treatments are available specifically targeted to Rett symptoms. High quality outcome measures, specific to the core symptoms of a disorder are a critical component of well-designed clinical trials for individuals with neurodevelopmental disorders. The Clinical Global Impression Scale is a measure of global clinical change with strong face validity that has been widely used as an outcome measure in clinical trials of central nervous system disorders. Despite its favorable assay sensitivity in clinical trials, as a global measure, the Clinical Global Impression Scale is not specific to the signs and symptoms of the disorder under study. Development of key anchors for the scale, specific to the disorder being assessed, holds promise for enhancing the validity and reliability of the measure for disorders such as Rett syndrome.

  14. The Development of NOAA Education Common Outcome Performance Measures (Invited)

    Science.gov (United States)

    Baek, J.

    2013-12-01

    The National Oceanic and Atmospheric Administration (NOAA) Education Council has embarked on an ambitious Monitoring and Evaluation (M&E) project that will allow it to assess education program outcomes and impacts across the agency, line offices, and programs. The purpose of this internal effort is to link outcome measures to program efforts and to evaluate the success of the agency's education programs in meeting the strategic goals. Using an outcome-based evaluation approach, the NOAA Education Council is developing two sets of common outcome performance measures, environmental stewardship and professional development. This presentation will examine the benefits and tradeoffs of common outcome performance measures that collect program results across a portfolio of education programs focused on common outcomes. Common outcome performance measures have a few benefits to our agency and to the climate education field at large. The primary benefit is shared understanding, which comes from our process for writing common outcome performance measures. Without a shared and agreed upon set of definitions for the measure of an outcome, the reported results may not be measuring the same things and would incorrectly indicate levels of performance. Therefore, our writing process relies on a commitment to developing a shared set of definitions based on consensus. We hope that by taking the time to debate and coming to agreement across a diverse set of programs, the strength of our common measures can indicate real progress towards outcomes we care about. An additional benefit is that these common measures can be adopted and adapted by other agencies and organizations that share similar theories of change. The measures are not without their drawbacks, and we do make tradeoffs as part of our process in order to continue making progress. We know that any measure is necessarily a narrow slice of performance. A slice that may not best represent the unique and remarkable contribution

  15. Improving Outcome Measures Other Than Achievement

    Directory of Open Access Journals (Sweden)

    Kristin Anderson Moore

    2015-05-01

    Full Text Available Research indicates that educational, economic, and life success reflect children’s nonacademic as well as academic competencies. Therefore, longitudinal surveys that assess educational progress and success need to incorporate nonacademic measures to avoid omitted variable bias, inform development of new intervention strategies, and support mediating and moderating analyses. Based on a life course model and a whole child perspective, this article suggests constructs in the domains of child health, emotional/psychological development, educational achievement/attainment, social behavior, and social relationships. Four critical constructs are highlighted: self-regulation, agency/motivation, persistence/diligence, and executive functioning. Other constructs that are currently measured need to be retained, including social skills, positive relationships, activities, positive behaviors, academic self-efficacy, educational engagement, and internalizing/emotional well-being. Examples of measures that are substantively and psychometrically robust are provided.

  16. Clinical outcomes resulting from telemedicine interventions: a systematic review

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    Kraemer Dale

    2001-11-01

    Full Text Available Abstract Background The use of telemedicine is growing, but its efficacy for achieving comparable or improved clinical outcomes has not been established in many medical specialties. The objective of this systematic review was to evaluate the efficacy of telemedicine interventions for health outcomes in two classes of application: home-based and office/hospital-based. Methods Data sources for the study included deports of studies from the MEDLINE, EMBASE, CINAHL, and HealthSTAR databases; searching of bibliographies of review and other articles; and consultation of printed resources as well as investigators in the field. We included studies that were relevant to at least one of the two classes of telemedicine and addressed the assessment of efficacy for clinical outcomes with data of reported results. We excluded studies where the service did not historically require face-to-face encounters (e.g., radiology or pathology diagnosis. All included articles were abstracted and graded for quality and direction of the evidence. Results A total of 25 articles met inclusion criteria and were assessed. The strongest evidence for the efficacy of telemedicine in clinical outcomes comes from home-based telemedicine in the areas of chronic disease management, hypertension, and AIDS. The value of home glucose monitoring in diabetes mellitus is conflicting. There is also reasonable evidence that telemedicine is comparable to face-to-face care in emergency medicine and is beneficial in surgical and neonatal intensive care units as well as patient transfer in neurosurgery. Conclusions Despite the widespread use of telemedicine in virtually all major areas of health care, evidence concerning the benefits of its use exists in only a small number of them. Further randomized controlled trials must be done to determine where its use is most effective.

  17. Disruptive behavior and clinical outcomes: perceptions of nurses and physicians.

    Science.gov (United States)

    Rosenstein, Alan H; O'Daniel, Michelle

    2005-01-01

    Providing safe, error-free care is the number-one priority of all health care professionals. Excellent outcomes have been associated with procedural efficiency, the implementation of evidence-based standards, and the use of tools designed to reduce the likelihood of medical error (such as computerized medication orders and bar-coded patient identification). But the impact of work relationships on clinical outcomes isn't as well documented. The current survey was designed as a follow-up to a previous VHA West Coast survey that examined the prevalence and impact of physicians' disruptive behavior on the job satisfaction and retention of nurses (see "Nurse-Physician Relationships: Impact on Nurse Satisfaction and Retention," June 2002). Based on the findings of that survey and subsequent comments on it, the follow-up survey examined the disruptive behavior of both physicians and nurses, as well as both groups' and administrators' perceptions of its effects on providers and its impact on clinical outcomes. Surveys were distributed to 50 VHA hospitals across the country, and results from more than 1,500 survey participants were evaluated. Nurses were reported to have behaved disruptively almost as frequently as physicians. Most respondents perceived disruptive behavior as having negative or worsening effects, in both nurses and physicians, on stress, frustration, concentration, communication, collaboration, information transfer, and workplace relationships. Even more disturbing was the respondents' perceptions of negative or worsening effects of disruptive behavior on adverse events, medical errors, patient safety, patient mortality, the quality of care, and patient satisfaction. These findings suggest that the consequences of disruptive behavior go far beyond nurses' job satisfaction and morale, affecting communication and collaboration among clinicians, which may well, in turn, have a negative impact on clinical outcomes. Strategies aimed at reducing the incidence and

  18. Clinical outcomes of chemoradiotherapy for locally recurrent rectal cancer

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    Oh Jae Hwan

    2011-05-01

    Full Text Available Abstract Background To assess the clinical outcome of chemoradiotherapy with or without surgery for locally recurrent rectal cancer (LRRC and to find useful and significant prognostic factors for a clinical situation. Methods Between January 2001 and February 2009, 67 LRRC patients, who entered into concurrent chemoradiotherapy with or without surgery, were reviewed retrospectively. Of the 67 patients, 45 were treated with chemoradiotherapy plus surgery, and the remaining 22 were treated with chemoradiotherapy alone. The mean radiation doses (biologically equivalent dose in 2-Gy fractions were 54.6 Gy and 66.5 Gy for the chemoradiotherapy with and without surgery groups, respectively. Results The median survival duration of all patients was 59 months. Five-year overall (OS, relapse-free (RFS, locoregional relapse-free (LRFS, and distant metastasis-free survival (DMFS were 48.9%, 31.6%, 66.4%, and 40.6%, respectively. A multivariate analysis demonstrated that the presence of symptoms was an independent prognostic factor influencing OS, RFS, LRFS, and DMFS. No statistically significant difference was found in OS (p = 0.181, RFS (p = 0.113, LRFS (p = 0.379, or DMFS (p = 0.335 when comparing clinical outcomes between the chemoradiotherapy with and without surgery groups. Conclusions Chemoradiotherapy with or without surgery could be a potential option for an LRRC cure, and the symptoms related to LRRC were a significant prognostic factor predicting poor clinical outcome. The chemoradiotherapy scheme for LRRC patients should be adjusted to the possibility of resectability and risk of local failure to focus on local control.

  19. Clinical Coronary In-Stent Restenosis Follow-Up after Treatment and Analyses of Clinical Outcomes

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    Barbara Campos Abreu Marino

    2015-05-01

    Full Text Available Background: Clinical in-stent restenosis (CISR is the main limitation of coronary angioplasty with stent implantation. Objective: Describe the clinical and angiographic characteristics of CISR and the outcomes over a minimum follow-up of 12 months after its diagnosis and treatment. Methods: We analyzed in 110 consecutive patients with CISR the clinical presentation, angiographic characteristics, treatment and combined primary outcomes (cardiovascular death, nonfatal acute myocardial infarction [AMI] and combined secondary (unstable angina with hospitalization, target vessel revascularization and target lesion revascularization during a minimal follow-up of one year. Results: Mean age was 61 ± 11 years (68.2% males. Clinical presentations included acute coronary syndrome (ACS in 62.7% and proliferative ISR in 34.5%. CISR was treated with implantation of drug-eluting stents (DES in 36.4%, Bare Metal Stent (BMS in 23.6%, myocardial revascularization surgery in 18.2%, balloon angioplasty in 15.5% and clinical treatment in 6.4%. During a median follow-up of 19.7 months, the primary outcome occurred in 18 patients, including 6 (5.5% deaths and 13 (11.8% AMI events. Twenty-four patients presented a secondary outcome. Predictors of the primary outcome were CISR with DES (HR = 4.36 [1.44–12.85]; p = 0.009 and clinical treatment for CISR (HR = 10.66 [2.53–44.87]; p = 0.001. Treatment of CISR with BMS (HR = 4.08 [1.75–9.48]; p = 0.001 and clinical therapy (HR = 6.29 [1.35–29.38]; p = 0.019 emerged as predictors of a secondary outcome. Conclusion: Patients with CISR present in most cases with ACS and with a high frequency of adverse events during a medium-term follow-up.

  20. Clinical Coronary In-Stent Restenosis Follow-Up after Treatment and Analyses of Clinical Outcomes

    Science.gov (United States)

    Marino, Barbara Campos Abreu; Nascimento, Guilherme Abreu; Rabelo, Walter; Marino, Marcos Antônio; Marino, Roberto Luiz; Ribeiro, Antonio Luiz Pinho

    2015-01-01

    Background Clinical in-stent restenosis (CISR) is the main limitation of coronary angioplasty with stent implantation. Objective Describe the clinical and angiographic characteristics of CISR and the outcomes over a minimum follow-up of 12 months after its diagnosis and treatment. Methods We analyzed in 110 consecutive patients with CISR the clinical presentation, angiographic characteristics, treatment and combined primary outcomes (cardiovascular death, nonfatal acute myocardial infarction [AMI]) and combined secondary (unstable angina with hospitalization, target vessel revascularization and target lesion revascularization) during a minimal follow-up of one year. Results Mean age was 61 ± 11 years (68.2% males). Clinical presentations included acute coronary syndrome (ACS) in 62.7% and proliferative ISR in 34.5%. CISR was treated with implantation of drug-eluting stents (DES) in 36.4%, Bare Metal Stent (BMS) in 23.6%, myocardial revascularization surgery in 18.2%, balloon angioplasty in 15.5% and clinical treatment in 6.4%. During a median follow-up of 19.7 months, the primary outcome occurred in 18 patients, including 6 (5.5%) deaths and 13 (11.8%) AMI events. Twenty-four patients presented a secondary outcome. Predictors of the primary outcome were CISR with DES (HR = 4.36 [1.44–12.85]; p = 0.009) and clinical treatment for CISR (HR = 10.66 [2.53–44.87]; p = 0.001). Treatment of CISR with BMS (HR = 4.08 [1.75–9.48]; p = 0.001) and clinical therapy (HR = 6.29 [1.35–29.38]; p = 0.019) emerged as predictors of a secondary outcome. Conclusion Patients with CISR present in most cases with ACS and with a high frequency of adverse events during a medium-term follow-up. PMID:25651344

  1. Joint multiple imputation for longitudinal outcomes and clinical events that truncate longitudinal follow-up.

    Science.gov (United States)

    Hu, Bo; Li, Liang; Greene, Tom

    2016-07-30

    Longitudinal cohort studies often collect both repeated measurements of longitudinal outcomes and times to clinical events whose occurrence precludes further longitudinal measurements. Although joint modeling of the clinical events and the longitudinal data can be used to provide valid statistical inference for target estimands in certain contexts, the application of joint models in medical literature is currently rather restricted because of the complexity of the joint models and the intensive computation involved. We propose a multiple imputation approach to jointly impute missing data of both the longitudinal and clinical event outcomes. With complete imputed datasets, analysts are then able to use simple and transparent statistical methods and standard statistical software to perform various analyses without dealing with the complications of missing data and joint modeling. We show that the proposed multiple imputation approach is flexible and easy to implement in practice. Numerical results are also provided to demonstrate its performance. Copyright © 2015 John Wiley & Sons, Ltd.

  2. Novel mechanisms, treatments and outcome measures in childhood sleep

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    Annalisa eColonna

    2015-05-01

    Full Text Available Sleep disorders and sleep of insufficient duration and quality are on the increase due to changes in our lifestyle, particularly in children and adolescents. Sleep disruption is also more common in children with medical conditions, compounding their difficulties. Recent studies have focused on new mechanisms that explain how learning and cognitive performance depend on a good night’s sleep. Growing alongside this latest understanding is an innovative new field of non-drug interventions that improve sleep architecture, with resulting cognitive improvements. However, we need to rigorously evaluate such potentially popular and self-administered sleep interventions with equally state-of-the-art outcome measurement tools. Animated hand-held games, that incorporate embedded sleep-dependent learning tasks, promise to offer new robust methods of measuring changes in overnight learning. Portable computing technology has the potential to offer practical, inexpensive and reliable tools to indirectly assess the quality of sleep. They may be adopted in both clinical and educational settings, providing a unique way of monitoring the effect of sleep disruption on learning, leading also to a radical rethink of how we manage chronic diseases.

  3. Thyroid hormones association with depression severity and clinical outcome in patients with major depressive disorder.

    Science.gov (United States)

    Berent, Dominika; Zboralski, Krzysztof; Orzechowska, Agata; Gałecki, Piotr

    2014-01-01

    The clinical implications of thyroid hormones in depression have been studied extensively and still remains disputable. Supplementation of thyroid hormones is considered to augment and accelerate antidepressant treatment. Studies on the role of thyroid hormones in depression deliver contradictory results. Here we assess theirs impact on depression severity and final clinical outcome in patients with major depression. Thyrotropin, free thyroxine (FT4), and free triiodothyronine (FT3) concentrations were measured with automated quantitative enzyme immunoassay. Depression severity and final clinical outcome were rated with 17-itemic Hamilton Rating Scale for Depression [HDRS(17)] and Clinical Global Impression Scales for severity and for improvement (CGIs, CGIi). FT3 and FT4 concentrations were significantly positively correlated with clinical improvement evaluated with CGIi (R = 0.38, P = 0.012; R = 0.33, P = 0.034, respectively). There was a significant correlation between FT4 concentrations and depression severity assessed in HDRS(17) (R = 0.31, P = 0.047). Male patients presented significantly higher FT3 serum levels (Z = 2.34, P = 0.018) and significantly greater clinical improvement (Z = 2.36, P = 0.018) when compared to female patients. We conclude that free thyroid hormones concentrations are associated with depression severity and have an impact on final clinical outcome. It can be more efficient to augment and accelerate the treatment of major depressive disorder with triiodothyronine instead of levothyroxine because of individual differences in thyroid hormones metabolism.

  4. Clinical outcome after traumatic spinal fractures in patients with ankylosing spinal disorders compared with control patients.

    NARCIS (Netherlands)

    Westerveld, L.A.; van Bemmel, J.C.; Dhert, W.J.A.; Öner, F.C.; Verlaan, J.J.

    2014-01-01

    Background context The clinical outcome of patients with ankylosing spinal disorders (ASDs) sustaining a spinal fracture has been described to be worse compared with the general trauma population. Purpose To investigate clinical outcome (neurologic deficits, complications, and mortality) after spina

  5. Prognostic factors influencing clinical outcomes of glioblastoma multiforme

    Institute of Scientific and Technical Information of China (English)

    LI Shou-wei; QIU Xiao-guang; CHEN Bao-shi; ZHANG Wei; REN Huan; WANG Zhong-cheng; JIANG Tao

    2009-01-01

    Background Glioblastoma multiforme (GBM) is the most malignant kind of astrocytic tumors and is associated with a poor prognosis. In this retrospective study, we assessed the clinical, radiological, genetic molecular and treatment factors that influence clinical outcomes of patients with GBM.Methods A total of 116 patients with GBM who received surgery and radiation between January 2006 and December 2007 were included in this study. Kaplan-Meier survival analysis and Cox regression analysis were used to find the factors independently influencing patients' progression free survival (PFS) time and overall survival (OS) time.Results Age, preoperative Kamofsky Performance Scale (KPS) score, KPS score change at 2 weeks after operation, neurological deficit symptoms, tumor resection extent, maximal tumor diameter, involvement of eloquent cortex or deep structure, involvement of brain lobe, Ki-67 expression level and adjuvant chemotherapy were statistically significant factors (P <0.05) for both PFS and OS in the univariate analysis. Cox proportional hazards modeling revealed that age ≤50 years, preoperative KPS score ≥80, KPS score change after operation ≥0, involvement of single frontal lobe,non-eloquent area or deep structure involvement, low Ki-67 expression and adjuvant chemotherapy were independent favorable factors (P <0.05) for patients' clinical outcomes.Conclusions Age at diagnosis, preoperative KPS score, KPS score change at 2 weeks postoperation, involvement of brain lobe, involvement of eloquent cortex or deep structure, Ki-67 expression level and adjuvant chemotherapy correlate significantly with the prognosis of patients with GBM.

  6. Clinical and neurocognitive outcome in symptomatic isovaleric acidemia

    Directory of Open Access Journals (Sweden)

    Grünert Sarah C

    2012-01-01

    Full Text Available Abstract Background Despite its first description over 40 years ago, knowledge of the clinical course of isovaleric acidemia (IVA, a disorder predisposing to severe acidotic episodes during catabolic stress, is still anecdotal. We aimed to investigate the phenotypic presentation and factors determining the neurological and neurocognitive outcomes of patients diagnosed with IVA following clinical manifestation. Methods Retrospective data on 21 children and adults with symptomatic IVA diagnosed from 1976 to 1999 were analyzed for outcome determinants including age at diagnosis and number of catabolic episodes. Sixteen of 21 patients were evaluated cross-sectionally focusing on the neurological and neurocognitive status. Additionally, 155 cases of patients with IVA published in the international literature were reviewed and analyzed for outcome parameters including mortality. Results 57% of study patients (12/21 were diagnosed within the first weeks of life and 43% (9/21 in childhood. An acute metabolic attack was the main cause of diagnostic work-up. 44% of investigated study patients (7/16 showed mild motor dysfunction and only 19% (3/16 had cognitive deficits. No other organ complications were found. The patients' intelligence quotient was not related to the number of catabolic episodes but was inversely related to age at diagnosis. In published cases, mortality was high (33% if associated with neonatal diagnosis, following manifestation at an average age of 7 days. Conclusions Within the group of "classical" organic acidurias, IVA appears to be exceptional considering its milder neuropathologic implications. The potential to avoid neonatal mortality and to improve neurologic and cognitive outcome under early treatment reinforces IVA to be qualified for newborn screening.

  7. Sensitivity as outcome measure of androgen replacement: the AMS scale

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    Dinger Juergen C

    2006-03-01

    Full Text Available Abstract Background The capacity of the AMS scale as clinical utility and as outcome measure still needs validation. Methods An open post-marketing study was performed by office-based physicians in Germany in 2004. We analysed data of 1670 androgen-deficient males who were treated with testosterone gel. The AMS scale was applied prior to and after 3 months treatment. Results The improvement of complaints under treatment relative to the baseline score was 30.7% (total score, 27.3% (psychological domain, 30.5% (somatic domain, and 30.7% (sexual domain, respectively. Patients with little or no symptoms before therapy improved by 9%, those with mild complaints at entry by 24%, with moderate by 32%, and with severe symptoms by 39% – compared with the baseline score. We showed that the distribution of complaints of testosterone deficient men before therapy almost returned to norm values after 12 weeks of testosterone treatment. Age, BMI, and total testosterone level at baseline did not modify the positive effect of androgen therapy. We also demonstrated that the AMS results can predict the independent (physician's opinion about the individual treatment effect. Both, sensitivity (correct prediction of a positive assessment by the physician and specificity (correct prediction of a negative assessment by the physician were over 70%, if about 22% improvement of the AMS total score was used as cut-off point. Conclusion The AMS scale showed a convincing ability to measure treatment effects on quality of life across the full range of severity of complaints. Effect modification by other variables at baseline was not observed. In addition, results of the scale can predict the subjective clinical expert opinion on the treatment efficiency.

  8. Management guidelines and outcome measures in polymyalgia rheumatica (PMR).

    Science.gov (United States)

    Dasgupta, B; Matteson, E L; Maradit-Kremers, H

    2007-01-01

    Polymyalgia rheumatica (PMR) is a common inflammatory rheumatic disease of the elderly that is subject to wide variations in clinical practice and is managed both in the primary and secondary care settings by general practitioners, rheumatologists and non-rheumatologists. Considerable uncertainty exists relating to diagnosis, management and outcome in patients with PMR. The guidelines presented here seek to improve outcomes for PMR patients by outlining a process to ensure more accurate diagnosis and timely specialist referral. The guidelines are directed to promote more conservative treatment and to ensure early bone protection in order to reduce the common morbidity of osteoporotic fractures. Furthermore, these guidelines specify the goals of treatment, including clinical and patient-based outcomes, and provide advice concerning monitoring for disease activity and complications.

  9. The clinical outcomes of chronic hepatitis C in South Korea

    Science.gov (United States)

    Ok, Kyeong Sam; Jeong, Sook-Hyang; Jang, Eun Sun; Kim, Young Seok; Lee, Youn Jae; Kim, In Hee; Cho, Sung Bum; Bae, Si Hyun; Lee, Han Chu

    2016-01-01

    Abstract This prospective cohort study aimed to elucidate the clinical outcome and its related factors of chronic hepatitis C in a hepatitis B-dominant Asian region. From January 2007 to October 2012, 382 patients with chronic hepatitis C without liver cirrhosis were prospectively enrolled at 6 university hospitals, and regularly followed until Apr 2014 to identify the development of liver cirrhosis, decompensated cirrhosis, hepatocellular carcinoma (HCC), and overall survival. During the median follow-up of 39.0 months (range 18.0–81.0 months), liver cirrhosis, hepatic decompensation, and HCC developed in 42 patients (11.0%), 4 patients (1.0%), and 12 patients (3.1%), respectively. The cumulative probability of development of cirrhosis at 3 years and at 5 years was 9.6% and 16.7%, respectively. That of HCC at 3 and 5 years was 1.6% and 4.5%, respectively. The 3-year and 5-year overall survival rate was 99.7% and 96.0%, respectively. Pegylated interferon-based antiviral therapy was undertaken in 237 patients (62.0%) with a sustained virologic response (SVR) rate of 74.3%. The factors related to the overall clinical outcomes were age ≥55 years (HR 2.924, P = 0.016), platelet counts <150  × 109/L (HR 3.195, P = 0.007), and the achievement of SVR (HR 0.254, P = 0.002). The clinical outcomes of this Korean chronic hepatitis C cohort were modest with minimal mortality, but significant disease progression occurred in the patients with old age, low platelet, and non-SVR after interferon-based antiviral treatment or no treatment, suggesting priority for direct acting antiviral therapy. PMID:27583874

  10. Clozapine induced myopericarditis: early recognition improves clinical outcome.

    Science.gov (United States)

    Razminia, Mansour; Salem, Yasser; Devaki, Sivasubramaniam; Shah, Nilamben; Khosla, Sandeep

    2006-01-01

    Clozapine is an atypical dibenzodiazepine antipsychotic used for resistant schizophrenia. Uncommonly, it is associated with myocarditis. We report a case of myopericarditis masquerading as an acute myocardial infarction based on presenting electrocardiogram and cardiac markers. Emergent coronary angiography confirmed the absence of epicardial coronary occlusion and revealed severe left ventricular systolic dysfunction. Immediate discontinuation of the clozapine, along with aggressive supportive care resulted in complete recovery to baseline. Cardiovascular health professionals should be aware of this uncommon but serious side effect of clozapine since failure to recognize the association may result in adverse clinical outcome and inappropriate therapy.

  11. Nursing outcomes content validation according to Nursing Outcomes Classification (NOC) for clinical, surgical and critical patients.

    Science.gov (United States)

    Seganfredo, Deborah Hein; Almeida, Miriam de Abreu

    2011-01-01

    The objective of this study was to validate the Nursing Outcomes (NO) from the Nursing Outcomes Classification (NOC) for the two Nursing Diagnoses (ND) most frequent in hospitalized surgical, clinical and critical patients. The content validation of the REs was performed adapting the Fehring Model. The sample consisted of 12 expert nurses. The instrument for data collection consisted of the NOs proposed by NOC for the two NDs in the study, its definition and a five-point Likert scale. The data were analyzed using descriptive statistics. The NOs that obtained averages of 0.80 or higher were validated. The ND Risk for Infection was the most frequent, being validated eight (38.1%) of 21 NOs proposed by the NOC. The ND Self-Care Deficit: Bathing/Hygiene was the second most frequent and five (14.28%) out of 35 NOs were validated.

  12. Portal hypertension due to portal venous thrombosis: Etiology, clinical outcomes

    Institute of Scientific and Technical Information of China (English)

    Ozgur Harmanci; Yusuf Bayraktar

    2007-01-01

    The thrombophilia in adult life has major implications in the hepatic vessels. The resulting portal vein thrombosis has various outcomes and complications. Esophageal varices, portal gastropathy, ascites, severe hypersplenism and liver failure needing liver transplantation are known well. The newly formed collateral venous circulation showing itself as pseudocholangicarcinoma sign and its possible clinical reflection as cholestasis are also known from a long time. The management strategies for these complications of portal vein thrombosis are not different from their counterpart which is cirrhotic portal hypertension, but the prognosis is unquestionably better in former cases. In this review we present and discuss the portal vein thrombosis, etiology and the resulting clinical pictures. There are controversial issues in nomenclature,management (including anticoagulation problems), follow up strategies and liver transplantation. In the light of the current knowledge, we discuss some controversial issues in literature and present our experience and our proposals about this group of patients.

  13. Autogenic training: a narrative and quantitative review of clinical outcome.

    Science.gov (United States)

    Linden, W

    1994-09-01

    This review of controlled outcome research on Autogenic Training complements the literature by pooling narrative and quantitative approaches, by including only studies with experimental controls, by integrating the English and German literature, and by adding research findings published since the last review. Whereas previous reviews have already reported positive effects of Autogenic Training for migraine, insomnia, and test anxiety, additional supportive findings for angina pectoris, asthma, childbirth, eczema, hypertension, infertility, Raynaud's disease, and recovery from myocardial infarction are discussed here. The impact of protocol variations on outcome is described, and the specificity of Autogenic Training relative to other stress management techniques is highlighted. Quantitative findings suggested that Autogenic Training was associated with medium-sized pre- to posttreatment effects ranging from d = .43 for biological indices of change to d = .58 for psychological and behavioral indices thus matching effect sizes for other biobehavioral treatment techniques like biofeedback and muscular relaxation. Length of treatment did not affect clinical outcome. The discussion emphasizes how narrative and quantitative strategies complement one another.

  14. Neurobrucellosis: clinical, diagnostic, therapeutic features and outcome. Unusual clinical presentations in an endemic region

    OpenAIRE

    Nurgul Ceran; Recai Turkoglu; Ilknur Erdem; Asuman Inan; Derya Engin; Hulya Tireli; Pasa Goktas

    2011-01-01

    Brucellosis is a zoonotic infection and has endemic characteristics. Neurobrucellosis is an uncommon complication of this infection. The aim of this study was to present unusual clinical manifestations and to discuss the management and outcome of a series of 18 neurobrucellosis cases. Initial clinical manifestations consist of pseudotumor cerebri in one case, white matter lesions and demyelinating syndrome in three cases, intracranial granuloma in one case, transverse myelitis in two cases, s...

  15. Entanglement-assisted guessing of complementary measurement outcomes

    NARCIS (Netherlands)

    Berta, M.; Coles, P.J.; Wehner, S.D.C.

    2014-01-01

    Heisenberg's uncertainty principle implies that if one party (Alice) prepares a system and randomly measures one of two incompatible observables, then another party (Bob) cannot perfectly predict the measurement outcomes. This implication assumes that Bob does not possess an additional system that i

  16. Intraocular lens iris fixation. Clinical and macular OCT outcomes

    Directory of Open Access Journals (Sweden)

    Garcia-Rojas Leonardo

    2012-10-01

    Full Text Available Abstract Background To assess the efficacy, clinical outcomes, visual acuity (VA, incidence of adverse effects, and complications of peripheral iris fixation of 3-piece acrylic IOLs in eyes lacking capsular support. Thirteen patients who underwent implantation and peripheral iris fixation of a 3-piece foldable acrylic PC IOL for aphakia in the absence of capsular support were followed after surgery. Clinical outcomes and macular SD-OCT (Cirrus OCT; Carl Zeiss Meditec, Germany were analyzed. Findings The final CDVA was 20/40 or better in 8 eyes (62%, 20/60 or better in 12 eyes (92%, and one case of 20/80 due to corneal astigmatism and mild persistent edema. No intraoperative complications were reported. There were seven cases of medically controlled ocular hypertension after surgery due to the presence of viscoelastic in the AC. There were no cases of cystoid macular edema, chronic iridocyclitis, IOL subluxation, pigment dispersion, or glaucoma. Macular edema did not develop in any case by means of SD-OCT. Conclusions We think that this technique for iris suture fixation provides safe and effective results. Patients had substantial improvements in UDVA and CDVA. This surgical strategy may be individualized however; age, cornea status, angle structures, iris anatomy, and glaucoma are important considerations in selecting candidates for an appropriate IOL fixation method.

  17. The roles of funding source, clinical trial outcome, and quality of reporting in orthopedic surgery literature.

    Science.gov (United States)

    Khan, Safdar N; Mermer, Matthew J; Myers, Elizabeth; Sandhu, Harvinder S

    2008-12-01

    Compared with nonfunded or peer-reviewed funded projects, industry-sponsored clinical trials have traditionally been associated with more positive results. This relationship has been extensively studied in the nonsurgical literature. Although a few authors have addressed specialties, little has been reported on orthopedic clinical trials and their association with funding, study outcome, and efforts to reduce bias after randomization across journals of multiple subspecialties. For the study reported here, we selected 5 major orthopedic subspecialty journals: Journal of Bone and Joint Surgery (American Volume), Spine, Journal of Arthroplasty, Journal of Orthopaedic Trauma, and American Journal of Sports Medicine. We chose a 2-year limit for investigation (2002-2004); included all original randomized clinical trials reported in these 5 journals; and examined these trials for their study design, funding source, outcome, bias potential, and conclusion reached. Support for the 100 eligible orthopedic clinical trials was stated as coming from industry (26 trials, 26%), nonprofit sources (19 trials, 19%), and mixed sources (5 trials, 5%); no support was stated in 46 trials (46%), and support was not reported in 4 trials (4%). Of the 26 trials reporting industry support, 22 (85%) were graded as indicating an outcome favorable to the new treatment. The association between industry funding and favorable outcome was strong and significant (PJournal of Bone and Joint Surgery and Spine, measures taken to reduce bias were not documented.

  18. Routine outcome measurement in the Netherlands - A focus on benchmarking.

    Science.gov (United States)

    Delespaul, Philippe A E G

    2015-01-01

    Routine outcome measurement (ROM) is a 'hot' topic in the Netherlands. Over recent years the Netherlands have developed a centralized monitoring system for all reimbursed mental health interventions, in an attempt to improve the quality of care. The Foundation for Benchmarking Mental Health (SBG) is an independent knowledge centre for mental health providers and insurance companies. It was founded to organize and manage the countrywide ROM initiative. A Dutch countrywide ROM initiative is appealing, and the procedures in the Netherlands are described. However, the national ROM system was oversold. Arguments are discussed. It would have been a far better strategy if insurance companies and authorities had not focused on a national system but stimulated local data collection and requested a managerial plan-do-check-act (PDCA) cycle to stimulate service improvements from year to year. Within the same service, chances are higher that the same kind of clientele is served from year to year and therefore it will be easier to interpret the data. The ROM should regain its clinical focus. Mobile ROM systems using smartphones that collect sampled experiences could be an interesting future solution.

  19. A "Learning Platform" Approach to Outcome Measurement in Fragile X Syndrome: A Preliminary Psychometric Study

    Science.gov (United States)

    Hall, S. S.; Hammond, J. L.; Hirt, M.; Reiss, A. L.

    2012-01-01

    Background: Clinical trials of medications to alleviate the cognitive and behavioural symptoms of individuals with fragile X syndrome (FXS) are now underway. However, there are few reliable, valid and/or sensitive outcome measures available that can be directly administered to individuals with FXS. The majority of assessments employed in clinical…

  20. Longitudinal evaluation of patient-reported outcomes measurement information systems measures in pediatric chronic pain.

    Science.gov (United States)

    Kashikar-Zuck, Susmita; Carle, Adam; Barnett, Kimberly; Goldschneider, Kenneth R; Sherry, David D; Mara, Constance A; Cunningham, Natoshia; Farrell, Jennifer; Tress, Jenna; DeWitt, Esi Morgan

    2016-02-01

    The Patient-Reported Outcomes Measurement Information System (PROMIS) initiative is a comprehensive strategy by the National Institutes of Health to support the development and validation of precise instruments to assess self-reported health domains across healthy and disease-specific populations. Much progress has been made in instrument development, but there remains a gap in the validation of PROMIS measures for pediatric chronic pain. The purpose of this study was to investigate the construct validity and responsiveness to change of 7 PROMIS domains for the assessment of children (ages: 8-18) with chronic pain--Pain Interference, Fatigue, Anxiety, Depression, Mobility, Upper Extremity Function, and Peer Relationships. The PROMIS measures were administered at the initial visit and 2 follow-up visits at an outpatient chronic pain clinic (CPC; N = 82) and at an intensive amplified musculoskeletal pain day-treatment program (N = 63). Aim 1 examined construct validity of PROMIS measures by comparing them with corresponding "legacy" measures administered as part of usual care in the CPC sample. Aim 2 examined sensitivity to change in both CPC and amplified musculoskeletal pain samples. Longitudinal growth models showed that PROMIS' Pain Interference, Anxiety, Depression, Mobility, Upper Extremity, and Peer Relationship measures and legacy instruments generally performed similarly with slightly steeper slopes of improvement in legacy measures. All 7 PROMIS domains showed responsiveness to change. Results offered initial support for the validity of PROMIS measures in pediatric chronic pain. Further validation with larger and more diverse pediatric pain samples and additional legacy measures would broaden the scope of use of PROMIS in clinical research.

  1. How electrodiagnosis predicts clinical outcome of focal peripheral nerve lesions.

    Science.gov (United States)

    Robinson, Lawrence R

    2015-09-01

    This article reviews the electrodiagnostic (EDX) prognostic factors for focal traumatic and nontraumatic peripheral nerve injuries. Referring physicians and patients often benefit from general and nerve-specific prognostic information from the EDX consultant. Knowing the probable outcome from a nerve injury allows the referring physician to choose the best treatment options for his/her patients. Nerve injuries are variable in their mechanism, location, and pathophysiology. The general effects of the injuries on nerve and muscle are well known, but more research is needed for nerve-specific information. Several factors currently known to influence prognosis include: nature of the nerve trauma, amount of axon loss, recruitment in muscles supplied by the nerve, the extent of demyelination, and the distance to reinnervate functional muscles. This article reviews these general concepts and also nerve-specific EDX measures that predict outcome after focal neuropathies.

  2. Revised Hammersmith Scale for spinal muscular atrophy: A SMA specific clinical outcome assessment tool

    Science.gov (United States)

    Scoto, Mariacristina; Mayhew, Anna; Main, Marion; Mazzone, Elena S.; Montes, Jacqueline; de Sanctis, Roberto; Dunaway Young, Sally; Salazar, Rachel; Glanzman, Allan M.; Pasternak, Amy; Quigley, Janet; Mirek, Elizabeth; Duong, Tina; Gee, Richard; Civitello, Matthew; Tennekoon, Gihan; Pane, Marika; Pera, Maria Carmela; Bushby, Kate; Day, John; Darras, Basil T.; De Vivo, Darryl; Finkel, Richard; Mercuri, Eugenio; Muntoni, Francesco

    2017-01-01

    Recent translational research developments in Spinal Muscular Atrophy (SMA), outcome measure design and demands from regulatory authorities require that clinical outcome assessments are ‘fit for purpose’. An international collaboration (SMA REACH UK, Italian SMA Network and PNCRN USA) undertook an iterative process to address discontinuity in the recorded performance of the Hammersmith Functional Motor Scale Expanded and developed a revised functional scale using Rasch analysis, traditional psychometric techniques and the application of clinical sensibility via expert panels. Specifically, we intended to develop a psychometrically and clinically robust functional clinician rated outcome measure to assess physical abilities in weak SMA type 2 through to strong ambulant SMA type 3 patients. The final scale, the Revised Hammersmith Scale (RHS) for SMA, consisting of 36 items and two timed tests, was piloted in 138 patients with type 2 and 3 SMA in an observational cross-sectional multi-centre study across the three national networks. Rasch analysis demonstrated very good fit of all 36 items to the construct of motor performance, good reliability with a high Person Separation Index PSI 0.98, logical and hierarchical scoring in 27/36 items and excellent targeting with minimal ceiling. The RHS differentiated between clinically different groups: SMA type, World Health Organisation (WHO) categories, ambulatory status, and SMA type combined with ambulatory status (all p < 0.001). Construct and concurrent validity was also confirmed with a strong significant positive correlation with the WHO motor milestones rs = 0.860, p < 0.001. We conclude that the RHS is a psychometrically sound and versatile clinical outcome assessment to test the broad range of physical abilities of patients with type 2 and 3 SMA. Further longitudinal testing of the scale with regards change in scores over 6 and 12 months are required prior to its adoption in clinical trials. PMID:28222119

  3. Clinical outcomes in the surgical treatment of idiopathic normal pressure hydrocephalus.

    Science.gov (United States)

    Shaw, Richard; Everingham, Emma; Mahant, Neil; Jacobson, Erica; Owler, Brian

    2016-07-01

    Idiopathic normal pressure hydrocephalus (INPH) is a syndrome of gait disturbance, dementia and urinary incontinence. Outcomes after ventriculoperitoneal shunting for INPH are variable due to a lack of reliable, quantitative outcome data and inconsistent methods of selecting shunt candidates. The aim of this retrospective cohort study was to assess objective and quantitative clinical outcomes of ventriculoperitoneal shunting for INPH. From 2008 to 2013, consecutive patients diagnosed with INPH based on clinical and radiological criteria were included in this single-centre study. All patients received programmable-valve ventriculoperitoneal shunts. Outcome measures were assessed at baseline, 3, 6 and 12months post-operatively. Outcomes included gait time and scores on the Unified Parkinson's Disease Rating Scale part III (UPDRS-III), the Addenbrooke's Cognitive Examination Revised (ACE-R) and the Mini-Mental State Examination (MMSE). Thresholds for improvements were set a priori as ⩾20% decrease in gait time, ⩾10point decrease in UPDRS-III score, ⩾5point increase in ACE-R score and ⩾2point increase in MMSE score at last follow-up. The proportion of patients improving varied between measures, being gait time (60%), UPDRS-III (69%), MMSE (63%), and ACE-R (56%). Overall, improvement in at least one outcome measure was observed in 85% of patients and 38% improved in gait time, UPDRS-III score and cognitive scores. Only 15% of patients experienced no improvement on any measure. This study demonstrates that the majority of INPH patients can sustain improvements in multiple symptoms up to 12months after shunting.

  4. Measuring outcomes and efficiency in medicare value-based purchasing.

    Science.gov (United States)

    Tompkins, Christopher P; Higgins, Aparna R; Ritter, Grant A

    2009-01-01

    The Medicare program may soon adopt value-based purchasing (VBP), in which hospitals could receive incentives that are conditional on meeting specified performance objectives. The authors advocate for a market-oriented framework and direct measures of system-level value that are focused on better outcomes and lower total cost of care. They present a multidimensional framework for measuring outcomes of care and a method to adjust incentive payments based on efficiency. Incremental reforms based on VBP could provoke transformational changes in total patient care by linking payments to value related to the whole patient experience, recognizing shared accountability among providers.

  5. Validity and reliability of patient reported outcomes used in Psoriasis: results from two randomized clinical trials

    OpenAIRE

    Koo John; Thompson Christine; Stone Stephen P; Bresnahan Brian W; Shikiar Richard; Revicki Dennis A

    2003-01-01

    Abstract Background Two Phase III randomized controlled clinical trials were conducted to assess the efficacy, safety, and tolerability of weekly subcutaneous administration of efalizumab for the treatment of psoriasis. Patient reported measures of psoriasis-related functionality and health-related quality of life and of psoriasis-related symptom assessments were included as part of the trials. Objective To assess the reliability, validity, and responsiveness of the patient reported outcome m...

  6. Clinical and Radiographic Outcomes of Transforaminal Lumbar Interbody Fusion in Patients with Osteoporosis

    OpenAIRE

    Formby, Peter M.; Kang, Daniel G.; Helgeson, Melvin D.; Wagner, Scott C.

    2016-01-01

    Study Design Retrospective review. Objective To compare clinical outcomes after transforaminal lumbar interbody fusion (TLIF) in patients with and patients without osteoporosis. Methods We reviewed all patients with 6-month postoperative radiographs and computed tomography (CT) scans for evaluation of the interbody cage. CT Hounsfield unit (HU) measurements of the instrumented vertebral body were used to determine whether patients had osteoporosis. Radiographs and CT scans were evaluated for ...

  7. Outcomes measurement in patients with head and neck cancer.

    Science.gov (United States)

    Gourin, Christine G

    2014-03-01

    Outcomes research is defined as clinical and population-based research that investigates the results of healthcare practices or interventions through the filter of the benefit to the patient and other stakeholders. Outcomes research is an increasingly important field or research, because of the pressing need for evidence-based information that can be used to make better informed health and healthcare decisions, and define desired health care practices in the current era of healthcare reform. This article will review the head and neck cancer (HNCA) outcomes literature published in the past year, with a focus on studies evaluating treatment and survival, short-term and long-term complications, and quality of life (QOL).

  8. Outcomes assessment of a pharmacist-directed seamless care program in an ambulatory oncology clinic.

    Science.gov (United States)

    Edwards, Scott J; Abbott, Rick; Edwards, Jonathan; LeBlanc, Michael; Dranitsaris, George; Donnan, Jennifer; Laing, Kara; Whelan, Maria A; MacKinnon, Neil J

    2014-02-01

    The primary goal of seamless care is improved patient outcomes and improved standards of care for patients with cancer. The pharmacy service of the Newfoundland Cancer Treatment and Research Foundation conducted a randomized control study that measured clinical and humanistic outcomes of a pharmacist-directed seamless care program in an ambulatory oncology clinic. This article focuses on the intervention group, particularly the identification of drug-related problems (DRPs) and utilization of health care services as well the satisfaction of 3 types of health professionals with the services provided by the pharmacist-directed seamless care program. Overall, the seamless care pharmacist (SCP) identified an average of 3.7 DRPs per intervention patient; the most common DRP reported was a patient not receiving or taking a drug therapy for which there is an indication. The SCP identified more DRPs in patients receiving adjuvant treatment compared to those receiving palliative treatment. On average, family physicians, oncology nurses, and hospital pharmacists were satisfied with the SCP intervention indicating that they agreed the information collected and distributed by the SCP was useful to them. Pharmacist-directed seamless care services in an ambulatory oncology clinic have a significant impact on clinical outcomes and processes of patient care. The presence of a SCP can help identify and resolve DRPs experienced by patients in an outpatient oncology clinic, ensuring that patients are receiving the highest standard of care.

  9. Clinical manifestations and outcomes in severe ulcerative colitis

    Institute of Scientific and Technical Information of China (English)

    YANG Xuesong; YAO Wei; LIU Wenbin; LI Jun; LU Yumin

    2007-01-01

    In order to evaluate the clinical manifestations and outcomes of severe ulcerative colitis (UC),we retrospectively reviewed 41 patients with severe UC from 144 consecutively hospitalized UC cases from 1988 to 2004.Data recorded included onset,symptoms,signs,laboratory results,endoscopic,radiologic and pathologic findings,the clinical treatment process and follow-up.Of these severe cases,92.7%(38/41)had pancolitis.Clinically,36.9%(15/41)were categorized as first onset type,36.9%(15/41)were chronic persistent and 26.8%(11/41)were chronic recurrent.Steroids played a main role in the remission of severe UC(61.0%).Thirty-one cases(75.6%) were relieved by drug therapy.Seven cases(17.1%) progressed to the need for operation.An early age of onset,pancolitis,low hemoglobin and serum albumin levels,and the need for intravenous steroids tended to be associated with the need for surgery.In conclusion,most of the severe UC patients respond well to drug therapy,but for individuals who are unresponsive to drug therapy,or for those depending on steroids,after a reasonable duration of treatment,the necessity for surgery should be considered.

  10. Clinical outcomes of pars plicata anterior vitrectomy: 2-year results

    Directory of Open Access Journals (Sweden)

    Priya Narang

    2015-01-01

    Full Text Available Purpose: To demonstrate the safety and outcome of a surgical approach that uses pars plicata site for anterior vitrectomy during phacoemulsification procedure complicated by posterior capsule rupture and residual cortical matter. Design: Single center, retrospective, interventional, noncomparative study. Materials and Methods: Medical records of a consecutive series of 35 eyes of 35 patients who underwent pars plicata anterior vitrectomy (PPAV were reviewed. The main outcome measures were corrected and uncorrected distance visual acuity (CDVA, UDVA, early and late postoperative complications and intraocular pressure (IOP. Ultrasound biomicroscopic (UBM evaluation of sclerotomy site and spectral domain optical coherence tomography analysis for central macular thickness (CMT was performed. The final visual outcome at 2 years was evaluated. Results: At 2 years follow-up, the mean postoperative UDVA (logarithm of the minimum angle of resolution [logMAR] and CDVA (logMAR was 0.49 ± 0.26 and 0.19 ± 0.14, respectively. There was no significant change in the IOP (P = 0.061 and the mean CMT at 2 years was 192.5 ± 5.54 mm. The postoperative UBM image of the sclerotomy site at 8 weeks demonstrated a clear wound without any vitreous adhesion or incarceration. Intraoperative hyphema was seen in 1 (2.8% case and postoperative uveitis was seen in 2 (5.7% cases, which resolved with medications. No case of an iatrogenic retinal break or retinal detachment was reported. Conclusions: PPAV enables a closed chamber approach, allows thorough cleanup of vitreous in the pupillary plane and anterior chamber and affords better access to the subincisional and retropupillary cortical remnant with a significant visual outcome and an acceptable complication rate.

  11. Clinical Outcomes After Suture Anchor Repair of Recalcitrant Medial Epicondylitis.

    Science.gov (United States)

    Grawe, Brian M; Fabricant, Peter D; Chin, Christopher S; Allen, Answorth A; DePalma, Brian J; Dines, David M; Altchek, David W; Dines, Joshua S

    2016-01-01

    This study evaluated clinical and patient-reported outcomes and return to sport after surgical treatment of medial epicondylitis with suture anchor fixation. Consecutive patients were evaluated after undergoing debridement and suture anchor repair of the flexor-pronator mass for the treatment of medial epicondylitis. Demographic variables, a short version of the Disabilities of the Arm, Shoulder and Hand (QuickDASH) score, Oxford Elbow Score (OES), and 10-point pain and satisfaction scales were collected. Ability and time to return to sport after surgery were evaluated, and the relationship between predictor variables and both elbow function and return to sport was investigated. Median age at the time of surgery was 55 years (range, 29-65 years), with median follow-up of 40 months (range, 12-67 months). Median QuickDASH score and OES at final follow-up were 2.3 (range, 0-38.6) and 45 (range, 22-48), respectively. Most patients returned to premorbid sporting activities at a median of 4.5 months (range, 2.5-12 months), whereas 4 patients (14%) reported significant limitations at final follow-up. Older age at the time of surgery was predictive of better QuickDASH score and OES (P=.05 and P=.02, respectively). Patients who underwent surgery after a shorter duration of symptoms had better outcomes, but the difference did not reach statistical significance (QuickDASH, P=.09; OES, P=.10). Surgical treatment of recalcitrant medial epicondylitis with suture anchor fixation offers good pain relief and patient satisfaction, with little residual disability. Older age at the time of surgery predicts a better outcome.

  12. Clinical decision making and outcome in the routine care of people with severe mental illness across Europe (CEDAR)

    DEFF Research Database (Denmark)

    Puschner, B; Becker, T; Mayer, B;

    2016-01-01

    and Satisfaction Scale (CDIS) measured involvement and satisfaction with a specific decision at all time points. Primary outcome was patient-rated unmet needs measured with the Camberwell Assessment of Need Short Appraisal Schedule (CANSAS). Mixed-effects multinomial regression was used to examine differences......Aims. Shared decision making has been advocated as a means to improve patient-orientation and quality of health care. There is a lack of knowledge on clinical decision making and its relation to outcome in the routine treatment of people with severe mental illness. This study examined preferred...... and experienced clinical decision making from the perspectives of patients and staff, and how these affect treatment outcome. Methods. "Clinical Decision Making and Outcome in Routine Care for People with Severe Mental Illness" (CEDAR; ISRCTN75841675) is a naturalistic prospective observational study...

  13. Aberrant Hedgehog Signaling and Clinical Outcome in Osteosarcoma

    Directory of Open Access Journals (Sweden)

    Winnie W. Lo

    2014-01-01

    Full Text Available Despite the importance of Hedgehog signaling in bone development, the relationship between Hedgehog pathway expression and osteosarcoma clinical characteristics and outcome has not been investigated. In this study of 43 high-grade human osteosarcoma samples, we detected high expression levels of the Hedgehog ligand gene, IHH, and target genes, PTCH1 and GLI1, in most samples. Further analysis in tumors of patients with localized disease at diagnosis identified coexpression of IHH and PTCH1 exclusively in large tumors. Higher levels of IHH were observed more frequently in males and patients with higher levels of GLI1 were more responsive to chemotherapy. Subgroup analysis by tumor size and IHH expression indicated that the well-known association between survival and tumor size was further refined when IHH levels were taken into consideration.

  14. Clinical Outcomes and Quality of Life in Recipients of Livers Donated after Cardiac Death

    Directory of Open Access Journals (Sweden)

    Neehar D. Parikh

    2015-01-01

    Full Text Available Donation after cardiac death (DCD has expanded in the last decade in the US; however, DCD liver utilization has flattened in recent years due to poor outcomes. We examined clinical and quality of life (QOL outcomes of DCD recipients by conducting a retrospective and cross-sectional review of patients from 2003 to 2010. We compared clinical outcomes of DCD recipients (n=60 to those of donation after brain death (DBD liver recipients (n=669 during the same time period. DCD recipients had significantly lower rates of 5-year graft survival (P<0.001 and a trend toward lower rates of 5-year patient survival (P=0.064 when compared to the DBD cohort. In order to examine QOL outcomes in our cohorts, we administered the Short Form Liver Disease Quality of Life questionnaire to 30 DCD and 60 DBD recipients. The DCD recipients reported lower generic and liver-specific QOL. We further stratified the DCD cohort by the presence of ischemic cholangiopathy (IC. Patients with IC reported lower QOL when compared to DBD recipients and those DCD recipients without IC (P<0.05. While the results are consistent with clinical experience, this is the first report of QOL in DCD recipients using standardized measures. These data can be used to guide future comparative effectiveness studies.

  15. Atrial Fibrillation Ablation in Systolic Dysfunction: Clinical and Echocardiographic Outcomes

    Directory of Open Access Journals (Sweden)

    Tasso Julio Lobo

    2015-01-01

    Full Text Available Background: Heart failure and atrial fibrillation (AF often coexist in a deleterious cycle. Objective: To evaluate the clinical and echocardiographic outcomes of patients with ventricular systolic dysfunction and AF treated with radiofrequency (RF ablation. Methods: Patients with ventricular systolic dysfunction [ejection fraction (EF <50%] and AF refractory to drug therapy underwent stepwise RF ablation in the same session with pulmonary vein isolation, ablation of AF nests and of residual atrial tachycardia, named "background tachycardia". Clinical (NYHA functional class and echocardiographic (EF, left atrial diameter data were compared (McNemar test and t test before and after ablation. Results: 31 patients (6 women, 25 men, aged 37 to 77 years (mean, 59.8±10.6, underwent RF ablation. The etiology was mainly idiopathic (19 p, 61%. During a mean follow-up of 20.3±17 months, 24 patients (77% were in sinus rhythm, 11 (35% being on amiodarone. Eight patients (26% underwent more than one procedure (6 underwent 2 procedures, and 2 underwent 3 procedures. Significant NYHA functional class improvement was observed (pre-ablation: 2.23±0.56; postablation: 1.13±0.35; p<0.0001. The echocardiographic outcome also showed significant ventricular function improvement (EF pre: 44.68%±6.02%, post: 59%±13.2%, p=0.0005 and a significant left atrial diameter reduction (pre: 46.61±7.3 mm; post: 43.59±6.6 mm; p=0.026. No major complications occurred. Conclusion: Our findings suggest that AF ablation in patients with ventricular systolic dysfunction is a safe and highly effective procedure. Arrhythmia control has a great impact on ventricular function recovery and functional class improvement.

  16. Use of Outcome Measurement by Paediatric AHPs in Northern Ireland

    Science.gov (United States)

    Harron, Anita; Titterington, Jill

    2016-01-01

    Background: Professional standards advocate routine use of outcome measurement (OM) in the practice of allied health professionals (AHPs). Historically, OM has focused on impairment and its immediate constraints on activity, while current policy encourages the development and addition of impact-based OM. There appears to be an assumption at this…

  17. Relationship of patient-reported outcomes with MRI measures in rheumatoid arthritis

    DEFF Research Database (Denmark)

    Baker, Joshua F; Conaghan, Philip G; Emery, Paul;

    2017-01-01

    PURPOSE: We assessed whether MRI measures of synovitis, osteitis and bone erosion were associated with patient-reported outcomes (PROs) in a longitudinal clinical trial setting among patients with rheumatoid arthritis (RA). METHODS: This longitudinal cohort of 291 patients with RA was derived from...... across treatment groups. CONCLUSIONS: MRI measures of inflammation and structural damage correlate independently with physical function, pain and patient global assessments. These observations support the validity of MRI biomarkers. TRIAL REGISTRATION NUMBER: NCT00264537; Post-results....

  18. Does commitment to rehabilitation influence clinical outcome of total hip resurfacing arthroplasty?

    Directory of Open Access Journals (Sweden)

    Zywiel Michael G

    2010-03-01

    Full Text Available Abstract Background The purpose of this study was to evaluate whether compliance and rehabilitative efforts were predictors of early clinical outcome of total hip resurfacing arthroplasty. Methods A cross-sectional survey was utilized to collect information from 147 resurfacing patients, who were operated on by a single surgeon, regarding their level of commitment to rehabilitation following surgery. Patients were followed for a mean of 52 months (range, 24 to 90 months. Clinical outcomes and functional capabilities were assessed utilizing the Harris hip objective rating system, the SF-12 Health Survey, and an eleven-point satisfaction score. A linear regression analysis was used to determine whether there was any correlation between the rehabilitation commitment scores and any of the outcome measures, and a multivariate regression model was used to control for potentially confounding factors. Results Overall, an increased level of commitment to rehabilitation was positively correlated with each of the following outcome measures: SF-12 Mental Component Score, SF-12 Physical Component Score, Harris Hip score, and satisfaction scores. These correlations remained statistically significant in the multivariate regression model. Conclusions Patients who were more committed to their therapy after hip resurfacing returned to higher levels of functionality and were more satisfied following their surgery.

  19. Measuring patient satisfaction for the Quality and Outcomes Framework

    OpenAIRE

    Hankins, Matthew; Fraser, Alice; Hodson, Andrew; Hooley, Claire; Smith, Helen

    2007-01-01

    The general medical services (GMS) contract Quality and Outcomes Framework (QOF) awards up to 70 points for measuring patient satisfaction with either the Improving Practices Questionnaire (IPQ) or the General Practice Assessment Questionnaire (GPAQ). The usefulness of data collected depends crucially on the validity and reliability of the measurement instrument. The literature was reviewed to assess the validity and reliability of these questionnaires. The literature was searched for peer-re...

  20. Kikuchi-Fujimoto disease: Clinical and laboratory characteristics and outcome

    Directory of Open Access Journals (Sweden)

    P S Rakesh

    2014-01-01

    Full Text Available Introduction: Kikuchi-Fujimoto disease is an uncommon disorder with worldwide distribution, characterized by fever and benign enlargement of the lymph nodes, primarily affecting young adults. Awareness about this disorder may help prevent misdiagnosis and inappropriate investigations and treatment. The objective of the study was to evaluate the clinical and laboratory characteristics of histopathologically confirmed cases of Kikuchi′s disease from a tertiary care center in southern India. Materials and Methods: Retrospective analysis of all adult patients with histopathologically confirmed Kikuchi′s disease from January 2007 to December 2011 in a 2700-bed teaching hospital in South India was done. The clinical and laboratory characteristics and outcome were analyzed. Results: There were 22 histopathologically confirmed cases of Kikuchi′s disease over the 5-year period of this study. The mean age of the subjects′ was 29.7 years (SD 8.11 and majority were women (Male: female- 1:3.4. Apart from enlarged cervical lymph nodes, prolonged fever was the most common presenting complaint (77.3%. The major laboratory features included anemia (54.5%, increased erythrocyte sedimentation rate (31.8%, elevated alanine aminotransferase (27.2% and elevated lactate dehydrogenase (LDH (31.8%. Conclusion: Even though rare, Kikuchi′s disease should be considered in the differential diagnosis of young individuals, especially women, presenting with lymphadenopathy and prolonged fever. Establishing the diagnosis histopathologically is essential to avoid inappropriate investigations and therapy.

  1. Clinical outcomes in patients with ICU-related pancreatitis

    Institute of Scientific and Technical Information of China (English)

    Chia-Cheng Tseng; Wen-Feng Fang; Yu-Hsiu Chung; Yi-Hsi Wang; Ivor S Douglas; Meng-Chih Lin

    2009-01-01

    AIM: To identify risk factors predictive of intensive care unit (ICU) mortality in patients with ventilatorrelated pancreatitis. The clinical outcomes of patients with ventilator-related pancreatitis were compared with those of patients with pancreatitis-related respiratory failure as well as controls.METHODS: One hundred and forty-eight patients with respiratory failure requiring mechanical ventilation and concomitant acute pancreatitis were identified from a prospectively collected dataset of 9108 consecutive patients admitted with respiratory failure over a period of five years. Sixty patients met the criteria for ventilator-related pancreatitis, and 88 (control patients), for pancreatitis-related respiratory failure.RESULTS: Mortality rate in ventilator-related pancreatitis was comparable to that in ICU patients without pancreatitis by case-control methodology ( P = 0.544). Multivariate logistic regression analysis identified low PaO_2/FiO_2 (OR: 1.032, 95% CI: 1.006-1.059, P = 0.016) as an independent risk factor for mortality in patients with ventilator-related pancreatitis. The mortality rate in patients with ventilator-related pancreatitis was lower than that in patients with acute pancreatitis-related respiratory failure ( P < 0.001).CONCLUSION: We found that low PaO_2/FiO_2 was an independent clinical parameter predictive of ICU mortality in patients with ventilator-related pancreatitis.

  2. Unconditionally secure bit commitment by transmitting measurement outcomes.

    Science.gov (United States)

    Kent, Adrian

    2012-09-28

    We propose a new unconditionally secure bit commitment scheme based on Minkowski causality and the properties of quantum information. The receiving party sends a number of randomly chosen Bennett-Brassard 1984 (BB84) qubits to the committer at a given point in space-time. The committer carries out measurements in one of the two BB84 bases, depending on the committed bit value, and transmits the outcomes securely at (or near) light speed in opposite directions to remote agents. These agents unveil the bit by returning the outcomes to adjacent agents of the receiver. The protocol's security relies only on simple properties of quantum information and the impossibility of superluminal signalling.

  3. Unconditionally Secure Bit Commitment by Transmitting Measurement Outcomes

    CERN Document Server

    ,

    2011-01-01

    We propose a new unconditionally secure bit commitment scheme based on Minkowski causality and the properties of quantum information. The receiving party sends a number of randomly chosen BB84 qubits to the committer at a given point in space-time. The committer carries out measurements in one of the two BB84 bases, depending on the committed bit value, and transmits the outcomes securely at light speed in opposite directions to remote agents. These agents unveil the bit by returning the outcomes to adjacent agents of the receiver. The security proofs rely only on simple properties of quantum information and the impossibility of superluminal signalling.

  4. AB129. Osteogenesis imperfecta: clinical features and bisphosphonate treatment outcome

    Science.gov (United States)

    Can, Ngoc Thi Bich; Vu, Dung Chi; Bui, Thao Phuong; Nguyen, Khanh Ngoc

    2015-01-01

    Background and objective Osteogenesis imperfecta (OI) comprises a group of disorders principally affecting type I collagen which result in increased bone fragility. Children with severe OI suffer recurrent fractures, resulting in severe deformity and growth stunting in many cases, with loss of independent ambulation by the teenage years in over 50% of cases. Recently, cyclical intravenous treatment with pamidronate has proven of benefit to children with severe forms of OI. This article aims to describle clinical features and laboratory manifestations of patient with OI and evaluate outcome of bisphosphonate management. Methods Clinical features, biochemical finding, and management outcome of 104 cases were study. The patients were classified into four major subtypes of Sillience et al. 1979. Patients with severe types were treatment with pamidronate (Aredia) used Rauch protocol 2003. Results Now we have 196 patients (87 females and 109 males) but we studied focus on 104 patients from 98 families (60 males, 44 females) onset at 2.1±3.0 years (median 0.35) with the average fracture bone of 5.9±4.4 times. In there, 17% type I, 8% type II, 63% type III, and 12% type IV. Clinical features include of intrauterine fracture visible on ultrasound 35%, bone deformation after birth 68%, triangle face 76%, long bone deformation 91%, chest deformation 46%, scoliosis 27%, short status 90%, blue sclera 83%, dentinogenesis imperfecta 20%, hearing loss 6%. Thirty patients have been treated with pamidronate at 3.2±3.7 years (4 months to 8 years) during 13±0.8 months (6-30 months). Fourteen patients had fracture bone after 6 months of treatment but no patients had fracture bone after 12 months. Seven patients had been treatment after 1.6±0.5 years, BMD increase from 0.39±0.311 to 0.79±0.105 g/cm2 (P<0.05). One patient had fever reaction after first pamidronate infusion but controlled with standard antipyretic therapy, and do not recur in later treatments. Conclusions OI has

  5. Acute axonal damage predicts clinical outcome in patients with multiple sclerosis

    DEFF Research Database (Denmark)

    Lim, E.T; Sellebjerg, F; Jensen, C.V

    2005-01-01

    The objectives of this study were (1) to determine how cerebrospinal fluid (CSF) neurofilament heavy chain (NfH(SM134) and NfH(SM135)) levels relate to clinical outcome in optic neuritis (ON) and multiple sclerosis (MS) relapse patients treated with high dose oral methylprednisolone; and (2...... in the MS attack trial were treated with oral methylprednisolone. In the MS attack trial group, CSF NfH(SM134) and NfH(SM135) measured at week 3 and deltaCSF NfH(SMI34) levels from baseline to week 3 were predictive of clinical outcome at week 8 and 52. In the ON group, no such association was seen. When...... both groups were combined, baseline CSF NfH(SHM134) and NfH(SM135) correlated positively with baseline enhancing lesion volume (ELV) (r(s) =0.50, P

  6. Hyperglycemia and Clinical Outcome in Aneurysmal Subarachnoid Hemorrhage A Meta-Analysis

    NARCIS (Netherlands)

    N.D. Kruyt; G.J. Biessels; R.J. de Haan; M. Vermeulen; G.J.E. Rinkel; B. Coert; Y.B.W.E.M. Roos

    2009-01-01

    Background and Purpose-Hyperglycemia may worsen outcome after aneurysmal subarachnoid hemorrhage. We performed a systematic review to investigate the relation between admission hyperglycemia and outcome after aneurysmal subarachnoid hemorrhage. Methods-We included cohort studies or clinical trials o

  7. Evaluation of Clinical Outcome after Laparoscopic Antireflux Surgery in Clinical Practice: Still a Controversial Issue

    Directory of Open Access Journals (Sweden)

    Sandro Contini

    2011-01-01

    Full Text Available Background. Laparoscopic antireflux surgery has shown to be effective in controlling gastroesophageal reflux (GERD. Yet, a universally accepted definition and evaluation for treatment success/failure in GERD is still controversial. The purpose of this paper is to assess if and how the outcome variables used in the different studies could possibly lead to an homogeneous appraisal of the limits and indications of LARS. Methods. We analyzed papers focusing on the efficacy and outcome of LARS and published in English literature over the last 10 years. Results. Symptoms scores and outcome variables reported are dissimilar and not uniform. The most consistent parameter was patient's satisfaction (mean satisfaction rate: 88.9%. Antireflux medications are not a trustworthy outcome index. Endoscopy and esophageal manometry do not appear very helpful. Twenty-four hours pH metry is recommended in patients difficult to manage for recurrent typical symptoms. Conclusions. More uniform symptoms scales and quality of life tools are needed for assessing the clinical outcome after laparoscopic antireflux surgery. In an era of cost containment, objective evaluation tests should be more specifically addressed. Relying on patient's satisfaction may be ambiguous, yet from this study it can be considered a practical and simple tool.

  8. Measuring Learning Outcomes. A Learner Perspective in Auditing Education

    DEFF Research Database (Denmark)

    Holm, Claus; Steenholdt, Niels

    2000-01-01

    The ability to provide sensible measures for learning outcomes in accounting education is under increased scrutiny. In this paper we use a learner perspective in auditing education which reflects that some students taking accounting classes also are provided with on-the-job training in accounting...... firms. Hence knowledge about learning outcomes for different groups of students is essential information for educators as well as the accounting profession. Sensible measures are needed by educators in order to (1) chose teaching methods matching prerequisite skills among a heterogenous student body, (2...... for students taking a graduate auditing course reflect prior accounting work experience for some students and undergraduate accounting coursework experience for all students. This paper extends prior research on the role of declarative and procedural knowledge in performing auditing tasks. Measuring learning...

  9. Measuring Learning Outcomes. A Learner Perspective in Auditing Education

    DEFF Research Database (Denmark)

    Holm, Claus; Steenholdt, Niels

    The ability to provide sensible measures for learning outcomes in accounting education is under increased scrutiny. In this paper we use a learner perspective in auditing education which reflects that some students taking accounting classes also are provided with on-the-job training in accounting...... firms. Hence knowledge about learning outcomes for different groups of students is essential information for educators as well as the accounting profession. Sensible measures are needed by educators in order to (1) chose teaching methods matching prerequisite skills among a heterogenous student body, (2...... for students taking a graduate auditing course reflect prior accounting work experience for some students and undergraduate accounting coursework experience for all students. This paper extends prior research on the role of declarative and procedural knowledge in performing auditing tasks. Measuring learning...

  10. Nutrition-Related Cardiovascular Disease Risk Factors In Chronic Kidney Disease: Relationship With Clinical Outcome

    Directory of Open Access Journals (Sweden)

    Emma McMahon

    2012-06-01

    Traditional CV-risk factors in this CKD population were not associated with clinical outcome. Despite being within clinical reference range, serum phosphate and albumin were independently associated with clinical outcome. This may highlight a potential therapeutic target for risk management to delay or prevent renal end-points in CKD.

  11. Comments on 'Guidance for Industry Patient-Reported Outcome Measures: Use in Medical Product Development to Support labeling Claims'.

    OpenAIRE

    Bradley, Clare

    2006-01-01

    I have a particular interest in the FDA's guidance on patient-reported outcome (PRO measures as I specialize in the design, development and use of such measures and license them to pharmaceutical companies, research organizations, academics and clinicians for use in clinical trials, other research and routine clinical practice. My measures include: the Diabetes Treatment Satisfaction Questionnaire (DTSQ) in it's status (DTSQs) and change (DTSQc) forms and related measures for other conditions...

  12. Clinical characteristics and perinatal outcome of fetal hydrops

    Science.gov (United States)

    Yeom, Wonkyung; Paik, E Sun; An, Jung-Joo; Oh, Soo-young; Roh, Cheong-Rae; Kim, Jong-Hwa

    2015-01-01

    Objective To investigate the clinical characteristics of fetal hydrops and to find the antenatal ultrasound findings predictive of adverse perinatal outcome. Methods This is a retrospective study of 42 women with fetal hydrops who delivered in a tertiary-referral center from 2005 to 2013. Fetal hydrops was defined as the presence of fluid collection in ≥2 body cavities: ascites, pleural effusion, pericardial effusion, and skin edema. Predictor variables recorded included: maternal characteristics, gestational age at diagnosis, ultrasound findings, and identifiable causes. Primary outcome variables analyzed were fetal death and neonatal death. Results The mean gestational age at diagnosis was 29.3±5.4 weeks (range, 18 to 39 weeks). The most common identifiable causes were cardiac abnormality (10), followed by syndrome (4), aneuploidy (3), congenital infection (3), twin-to-twin transfusion syndrome (3), non-cardiac anormaly (2), chorioangioma (2), inborn errors of metabolism (1), and immune hydrops by anti-E antibody isoimmunization (1). Thirteen cases had no definite identifiable causes. Three women elected termination of pregnancy. Fetal death occurred in 4 cases. Among the 35 live-born babies, only 16 survived (54.0% neonatal mortality rate). Fetal death and neonatal mortality rate was not significantly associated with Doppler velocimetry indices or location of fluid collection, but increasing numbers of fluid collection site was significantly associated with a higher risk of neonatal death. Conclusion The incidence of fetal hydrops in our retrospective study was 24.4 per 10,000 deliveries and the perinatal mortality rate was 61.9% (26/42). The number of fluid collection sites was the significant antenatal risk factor to predict neonatal death. PMID:25798421

  13. Paravalvular Regurgitation: Clinical Outcomes in Surgical and Percutaneous Treatments

    Directory of Open Access Journals (Sweden)

    Carlos Passos Pinheiro

    2016-01-01

    Full Text Available Abstract Background: Paravalvular regurgitation (paravalvular leak is a serious and rare complication associated with valve replacement surgery. Studies have shown a 3% to 6% incidence of paravalvular regurgitation with hemodynamic repercussion. Few studies have compared surgical and percutaneous approaches for repair. Objectives: To compare the surgical and percutaneous approaches for paravalvular regurgitation repair regarding clinical outcomes during hospitalization and one year after the procedure. Methods: This is a retrospective, descriptive and observational study that included 35 patients with paravalvular leak, requiring repair, and followed up at the Dante Pazzanese Institute of Cardiology between January 2011 and December 2013. Patients were divided into groups according to the established treatment and followed up for 1 year after the procedure. Results: The group submitted to percutaneous treatment was considered to be at higher risk for complications because of the older age of patients, higher prevalence of diabetes, greater number of previous valve surgeries and lower mean creatinine clearance value. During hospitalization, both groups had a large number of complications (74.3% of cases, with no statistical difference in the analyzed outcomes. After 1 year, the percutaneous group had a greater number of re-interventions (8.7% vs 20%, p = 0.57 and a higher mortality rate (0% vs. 20%, p = 0.08. A high incidence of residual mitral leak was observed after the percutaneous procedure (8.7% vs. 50%, p = 0.08. Conclusion: Surgery is the treatment of choice for paravalvular regurgitation. The percutaneous approach can be an alternative for patients at high surgical risk.

  14. Paravalvular Regurgitation: Clinical Outcomes in Surgical and Percutaneous Treatments

    Science.gov (United States)

    Pinheiro, Carlos Passos; Rezek, Daniele; Costa, Eduardo Paiva; de Carvalho, Edvagner Sergio Leite; Moscoso, Freddy Antonio Brito; Taborga, Percy Richard Chavez; Jeronimo, Andreia Dias; Abizaid, Alexandre Antonio Cunha; Ramos, Auristela Isabel de Oliveira

    2016-01-01

    Background Paravalvular regurgitation (paravalvular leak) is a serious and rare complication associated with valve replacement surgery. Studies have shown a 3% to 6% incidence of paravalvular regurgitation with hemodynamic repercussion. Few studies have compared surgical and percutaneous approaches for repair. Objectives To compare the surgical and percutaneous approaches for paravalvular regurgitation repair regarding clinical outcomes during hospitalization and one year after the procedure. Methods This is a retrospective, descriptive and observational study that included 35 patients with paravalvular leak, requiring repair, and followed up at the Dante Pazzanese Institute of Cardiology between January 2011 and December 2013. Patients were divided into groups according to the established treatment and followed up for 1 year after the procedure. Results The group submitted to percutaneous treatment was considered to be at higher risk for complications because of the older age of patients, higher prevalence of diabetes, greater number of previous valve surgeries and lower mean creatinine clearance value. During hospitalization, both groups had a large number of complications (74.3% of cases), with no statistical difference in the analyzed outcomes. After 1 year, the percutaneous group had a greater number of re-interventions (8.7% vs 20%, p = 0.57) and a higher mortality rate (0% vs. 20%, p = 0.08). A high incidence of residual mitral leak was observed after the percutaneous procedure (8.7% vs. 50%, p = 0.08). Conclusion Surgery is the treatment of choice for paravalvular regurgitation. The percutaneous approach can be an alternative for patients at high surgical risk. PMID:27305109

  15. Patient population management: taking the leap from variance analysis to outcomes measurement.

    Science.gov (United States)

    Allen, K M

    1998-01-01

    Case managers today at BCHS have a somewhat different role than at the onset of the Collaborative Practice Model. They are seen throughout the organization as: Leaders/participants on cross-functional teams. Systems change agents. Integrating/merging with quality services and utilization management. Outcomes managers. One of the major cross-functional teams is in the process of designing a Care Coordinator role. These individuals will, as one of their functions, assume responsibility for daily patient care management activities. A variance tracking program has come into the Utilization Management (UM) department as part of a software package purchased to automate UM work activities. This variance program could potentially be used by the new care coordinators as the role develops. The case managers are beginning to use a Decision Support software, (Transition Systems Inc.) in the collection of data that is based on a cost accounting system and linked to clinical events. Other clinical outcomes data bases are now being used by the case manager to help with the collection and measurement of outcomes information. Hoshin planning will continue to be a framework for defining and setting the targets for clinical and financial improvements throughout the organization. Case managers will continue to be involved in many of these system-wide initiatives. In the words of Galileo, 1579, "You need to count what's countable, measure what's measurable, and what's not measurable, make measurable."

  16. A Standard Set of Value-Based Patient-Centered Outcomes for Breast Cancer: The International Consortium for Health Outcomes Measurement (ICHOM) Initiative.

    Science.gov (United States)

    Ong, Wee Loon; Schouwenburg, Maartje G; van Bommel, Annelotte C M; Stowell, Caleb; Allison, Kim H; Benn, Karen E; Browne, John P; Cooter, Rodney D; Delaney, Geoff P; Duhoux, Francois P; Ganz, Patricia A; Hancock, Patricia; Jagsi, Reshma; Knaul, Felicia M; Knip, Anne M; Koppert, Linetta B; Kuerer, Henry M; McLaughin, Sarah; Mureau, Marc A M; Partridge, Ann H; Reid, Dereesa Purtell; Sheeran, Lisa; Smith, Thomas J; Stoutjesdijk, Mark J; Vrancken Peeters, Marie Jeanne T F D; Wengström, Yvonne; Yip, Cheng-Har; Saunders, Christobel

    2016-12-29

    A major challenge in value-based health care is the lack of standardized health outcomes measurements, hindering optimal monitoring and comparison of the quality of health care across different settings globally. The International Consortium for Health Outcomes Measurement (ICHOM) assembled a multidisciplinary international working group, comprised of 26 health care providers and patient advocates, to develop a standard set of value-based patient-centered outcomes for breast cancer (BC). The working group convened via 8 teleconferences and completed a follow-up survey after each meeting. A modified 2-round Delphi method was used to achieve consensus on the outcomes and case-mix variables to be included. Patient focus group meetings (8 early or metastatic BC patients) and online anonymized surveys of 1225 multinational BC patients and survivors were also conducted to obtain patients' input. The standard set encompasses survival and cancer control, and disutility of care (eg, acute treatment complications) outcomes, to be collected through administrative data and/or clinical records. A combination of multiple patient-reported outcomes measurement (PROM) tools is recommended to capture long-term degree of health outcomes. Selected case-mix factors were recommended to be collected at baseline. The ICHOM will endeavor to achieve wide buy-in of this set and facilitate its implementation in routine clinical practice in various settings and institutions worldwide.

  17. Clinical and angiographic outcomes after intracoronary bare-metal stenting.

    Directory of Open Access Journals (Sweden)

    I-Chang Hsieh

    Full Text Available BACKGROUND: Data from a large patient population regarding very long-term outcomes after BMS implantation are inadequate. This study aimed to evaluate the very long-term (8-17 years clinical and long-term (3-5 years angiographic outcomes after intracoronary bare-metal stenting (BMS. METHODS AND RESULTS: From the Cardiovascular Atherosclerosis and Percutaneous TrAnsluminal INterventions (CAPTAIN registry, a total of 2391 patients with 2966 lesions treated with 3190 BMSs between November 1995 and May 2004 were evaluated. In total, 1898 patients with 2364 lesions, and 699 patients with 861 lesions underwent 6-month and 3- to 5- year angiographic follow-up, respectively. During a mean follow-up period of 149 ± 51 months, 18.6% of the patients died (including 10.8% due to cardiac death, 6.1% developed reinfarction, 16.2% had target lesion revascularization (including 81% of the patients within the first year, 14.5% underwent new lesion stenting (including 72% of the patients after 3 years, 2.4% underwent coronary bypass surgery, and 1.6% had definite stent thrombosis. The overall cardiovascular event-free survival rate was 58.5%. The 6-month angiographic study indicated a 20% restenosis rate. The minimal luminal diameter increased from 0.65 ± 0.44 mm to 3.02 ± 0.46 mm immediately after stenting, decreased to 2.06 ± 0.77 mm at the 6-month follow-up, and increased to 2.27 ± 0.68 mm at the 3- to 5-year follow-up. CONCLUSIONS: This study provides clinical and angiographic results from a large population of patients who underwent BMS implantations after a long-term follow-up period (149 ± 51 months. The progression of coronary atherosclerosis developed over time, and presented with new lesion required stent implantation. The follow-up angiographic findings reconfirmed the late and sustained improvement in luminal diameter between 6 months and 3-5 years.

  18. Guest Editorial: Implementing outcome measures- The military physical therapists perspective

    Directory of Open Access Journals (Sweden)

    COL (Ret Paul D. Stoneman, PhD, MPT, DPT, OCS, SCS

    2013-10-01

    Full Text Available Outcome measures are a necessary part of rehabilitation. Various methods and measures have been used to assess patient progress and as criteria for discharge from inpatient care, routine outpatient care, and long-term rehabilitation in a variety of patient populations for many years. In the sports medicine setting, outcome measures become especially important in determining when injured athletes are able to return to the playing field. In a military setting, similar to sports medicine, the use of outcome measures is necessary to help determine when the patient is able to return to duty or deploy. In the case of servicemembers with traumatic limb loss, the ultimate goal for many is to return to Active Duty as a "tactical athlete" and member of today's Army, Navy, Air Force, Marine Corps, or Coast Guard. Determining the functional level and ability to meet the demands they may face is a challenge for the military healthcare system (MHCS and more specifically for the providers rehabilitating servicemembers with major limb loss.

  19. Regenerative Endodontic Treatment: Report of Two Cases with Different Clinical Management and Outcomes

    Directory of Open Access Journals (Sweden)

    Mehrfam Khoshkhounejad

    2015-11-01

    Full Text Available Endodontic intervention in necrotic immature permanent teeth is usually a clinical challenge. With appropriate case selection, regenerative treatment can be effective, providing a desirable outcome. However, there is still no consensus on the optimal disinfection protocol or the method to achieve predictable clinical outcome. This article presents two cases of regenerative treatment in necrotic immature teeth, using mineral trioxide aggregate (MTA and BiodentineTM as coronal barriers and different irrigants, which led to different clinical outcomes.

  20. Regenerative Endodontic Treatment: Report of Two Cases with Different Clinical Management and Outcomes.

    Science.gov (United States)

    Khoshkhounejad, Mehrfam; Shokouhinejad, Noushin; Pirmoazen, Salma

    2015-06-01

    Endodontic intervention in necrotic immature permanent teeth is usually a clinical challenge. With appropriate case selection, regenerative treatment can be effective, providing a desirable outcome. However, there is still no consensus on the optimal disinfection protocol or the method to achieve predictable clinical outcome. This article presents two cases of regenerative treatment in necrotic immature teeth, using mineral trioxide aggregate (MTA) and Biodentine(TM) as coronal barriers and different irrigants, which led to different clinical outcomes.

  1. Health outcomes in diabetics measured with Minnesota Community Measurement quality metrics

    Directory of Open Access Journals (Sweden)

    Takahashi PY

    2014-12-01

    Full Text Available Paul Y Takahashi,1 Jennifer L St Sauver,2 Lila J Finney Rutten,2 Robert M Jacobson,3 Debra J Jacobson,2 Michaela E McGree,2 Jon O Ebbert1 1Department of Internal Medicine, Division of Primary Care Internal Medicine, 2Department of Health Sciences Research, Mayo Clinic Robert D and Patricia E Kern Center for the Science of Health Care Delivery, 3Department of Pediatric and Adolescent Medicine, Division of Community Pediatrics, Mayo Clinic, Rochester, MN, USA Objective: Our objective was to understand the relationship between optimal diabetes control, as defined by Minnesota Community Measurement (MCM, and adverse health outcomes including emergency department (ED visits, hospitalizations, 30-day rehospitalization, intensive care unit (ICU stay, and mortality. Patients and methods: In 2009, we conducted a retrospective cohort study of empaneled Employee and Community Health patients with diabetes mellitus. We followed patients from 1 September 2009 until 30 June 2011 for hospitalization and until 5 January 2014 for mortality. Optimal control of diabetes mellitus was defined as achieving the following three measures: low-density lipoprotein (LDL cholesterol <100 mg/mL, blood pressure <140/90 mmHg, and hemoglobin A1c <8%. Using the electronic medical record, we assessed hospitalizations, ED visits, ICU stays, 30-day rehospitalizations, and mortality. The chi-square or Wilcoxon rank-sum tests were used to compare those with and without optimal control. We used Cox proportional hazard models to estimate the associations between optimal diabetes mellitus status and each outcome. Results: We identified 5,731 empaneled patients with diabetes mellitus; 2,842 (49.6% were in the optimal control category. After adjustment, we observed that non-optimally controlled patients had higher risks for hospitalization (hazard ratio [HR] 1.11; 95% confidence interval [CI] 1.00–1.23, ED visits (HR 1.15; 95% CI 1.06–1.25, and mortality (HR 1.29; 95% CI 1.09–1

  2. Nutritional Risk, Micronutrient Status and Clinical Outcomes: A Prospective Observational Study in an Infectious Disease Clinic

    Directory of Open Access Journals (Sweden)

    Oguzhan Sıtkı Dizdar

    2016-02-01

    Full Text Available Malnutrition has been associated with increased morbidity and mortality. The objective of this study was to determine the nutritional status and micronutrient levels of hospitalized patients in an infectious disease clinic and investigate their association with adverse clinical outcomes. The nutritional status of the study participants was assessed using the Nutritional Risk Screening 2002 (NRS 2002 and micronutrient levels and routine biochemical parameters were tested within the first 24 h of the patient’s admission. The incidence of zinc, selenium, thiamine, vitamin B6, vitamin B12 deficiency were 66.7% (n = 40, 46.6% (n = 29, 39.7% (n = 27, 35.3% (n = 24, 14.1% (n = 9, respectively. Selenium levels were significantly higher in patients with urinary tract infections, but lower in soft tissue infections. Copper levels were significantly higher in patients with soft tissue infections. In the Cox regression models, lower albumin, higher serum lactate dehydrogenase levels and higher NRS-2002 scores were associated with increased death. Thiamine, selenium, zinc and vitamin B6 deficiencies but not chromium deficiencies are common in infectious disease clinics. New associations were found between micronutrient levels and infection type and their adverse clinical outcomes. Hypoalbuminemia and a high NRS-2002 score had the greatest accuracy in predicting death, systemic inflammatory response syndrome and sepsis on admission.

  3. Simple measures of progress and outcome in the evaluation of mental health services.

    Science.gov (United States)

    Newman, F L; Hunter, R H; Irving, D

    1987-01-01

    There is a tautology regarding the use of progress and outcome measures. Such measures are easy to use in a reliable and valid fashion if the language of the measures is used as an integral part of (a) treatment planning and progress review, (b) clinical supervision, and (c) program management. The paper describes example guidelines and uses of measures in each of these functions. Also included are listings of scales with documented reliability and validity (by target population) and some sources for finding computer software for scoring some of the scales.

  4. Clinical Outcome Scoring of Intra-articular Calcaneal Fractures

    NARCIS (Netherlands)

    T. Schepers (Tim); M.J. Heetveld (Martin); P.G.H. Mulder (Paul); P. Patka (Peter)

    2008-01-01

    textabstractOutcome reporting of intra-articular calcaneal fractures is inconsistent. This study aimed to identify the most cited outcome scores in the literature and to analyze their reliability and validity. A systematic literature search identified 34 different outcome scores. The most cited outc

  5. Neurofeedback and biofeedback with 37 migraineurs: a clinical outcome study

    Directory of Open Access Journals (Sweden)

    Lappin Martha S

    2010-02-01

    Full Text Available Abstract Background Traditional peripheral biofeedback has grade A evidence for effectively treating migraines. Two newer forms of neurobiofeedback, EEG biofeedback and hemoencephalography biofeedback were combined with thermal handwarming biofeedback to treat 37 migraineurs in a clinical outpatient setting. Methods 37 migraine patients underwent an average of 40 neurofeedback sessions combined with thermal biofeedback in an outpatient biofeedback clinic. All patients were on at least one type of medication for migraine; preventive, abortive or rescue. Patients kept daily headache diaries a minimum of two weeks prior to treatment and throughout treatment showing symptom frequency, severity, duration and medications used. Treatments were conducted an average of three times weekly over an average span of 6 months. Headache diaries were examined after treatment and a formal interview was conducted. After an average of 14.5 months following treatment, a formal interview was conducted in order to ascertain duration of treatment effects. Results Of the 37 migraine patients treated, 26 patients or 70% experienced at least a 50% reduction in the frequency of their headaches which was sustained on average 14.5 months after treatments were discontinued. Conclusions All combined neuro and biofeedback interventions were effective in reducing the frequency of migraines with clients using medication resulting in a more favorable outcome (70% experiencing at least a 50% reduction in headaches than just medications alone (50% experience a 50% reduction and that the effect size of our study involving three different types of biofeedback for migraine (1.09 was more robust than effect size of combined studies on thermal biofeedback alone for migraine (.5. These non-invasive interventions may show promise for treating treatment-refractory migraine and for preventing the progression from episodic to chronic migraine.

  6. Systematic review of clinical outcomes after prophylactic surgery.

    Science.gov (United States)

    Davis, C R; Trevatt, Aej; Dixit, A; Datta, V

    2016-07-01

    Introduction Prophylactic appendicectomy is performed prior to military, polar and space expeditions to prevent acute appendicitis in the field. However, the risk-benefit ratio of prophylactic surgery is controversial. This study aimed to systematically review the evidence for prophylactic appendicectomy. It is supplemented by a clinical example of prophylactic surgery resulting in life-threatening complications. Methods A systematic review was performed using MEDLINE(®) and the Cochrane Central Register of Controlled Trials. Keyword variants of 'prophylaxis' and 'appendicectomy' were combined to identify potential papers for inclusion. Papers related to prophylactic appendicectomy risks and benefits were reviewed. Results Overall, 511 papers were identified, with 37 papers satisfying the inclusion criteria. Nine reported outcomes after incidental appendicectomy during concurrent surgical procedures. No papers focused explicitly on prophylactic appendicectomy in asymptomatic patients. The clinical example outlined acute obstruction secondary to adhesions from a prophylactic appendicectomy. Complications after elective appendicectomy versus the natural history of acute appendicitis in scenarios such as polar expeditions or covert operations suggest prophylactic appendicectomy may be appropriate prior to extreme situations. Nevertheless, the long-term risk of adhesion related complications render prophylactic appendicectomy feasible only when the short-term risk of acute appendicitis outweighs the long-term risks of surgery. Conclusions Prophylactic appendicectomy is rarely performed and not without risk. This is the first documented evidence of long-term complications following prophylactic appendicectomy. Surgery should be considered on an individual basis by balancing the risks of acute appendicitis in the field with the potential consequences of an otherwise unnecessary surgical procedure in a healthy patient.

  7. Below knee angioplasty in elderly patients: Predictors of major adverse clinical outcomes.

    LENUS (Irish Health Repository)

    Keeling, Aoife N

    2011-03-01

    To determine predictors of clinical outcome following percutaneous transluminal angioplasty (PTA) in elderly patients with below knee atherosclerotic lesions causing intermittent claudication (IC) or critical limb ischaemia (CLI).

  8. DTI measures track and predict motor function outcomes in stroke rehabilitation utilizing BCI technology.

    Science.gov (United States)

    Song, Jie; Nair, Veena A; Young, Brittany M; Walton, Leo M; Nigogosyan, Zack; Remsik, Alexander; Tyler, Mitchell E; Farrar-Edwards, Dorothy; Caldera, Kristin E; Sattin, Justin A; Williams, Justin C; Prabhakaran, Vivek

    2015-01-01

    Tracking and predicting motor outcomes is important in determining effective stroke rehabilitation strategies. Diffusion tensor imaging (DTI) allows for evaluation of the underlying structural integrity of brain white matter tracts and may serve as a potential biomarker for tracking and predicting motor recovery. In this study, we examined the longitudinal relationship between DTI measures of the posterior limb of the internal capsule (PLIC) and upper-limb motor outcomes in 13 stroke patients (median 20-month post-stroke) who completed up to 15 sessions of intervention using brain-computer interface (BCI) technology. Patients' upper-limb motor outcomes and PLIC DTI measures including fractional anisotropy (FA), axial diffusivity (AD), radial diffusivity (RD), and mean diffusivity (MD) were assessed longitudinally at four time points: pre-, mid-, immediately post- and 1-month-post intervention. DTI measures and ratios of each DTI measure comparing the ipsilesional and contralesional PLIC were correlated with patients' motor outcomes to examine the relationship between structural integrity of the PLIC and patients' motor recovery. We found that lower diffusivity and higher FA values of the ipsilesional PLIC were significantly correlated with better upper-limb motor function. Baseline DTI ratios were significantly correlated with motor outcomes measured immediately post and 1-month-post BCI interventions. A few patients achieved improvements in motor recovery meeting the minimum clinically important difference (MCID). These findings suggest that upper-limb motor recovery in stroke patients receiving BCI interventions relates to the microstructural status of the PLIC. Lower diffusivity and higher FA measures of the ipsilesional PLIC contribute toward better motor recovery in the stroke-affected upper-limb. DTI-derived measures may be a clinically useful biomarker in tracking and predicting motor recovery in stroke patients receiving BCI interventions.

  9. Measuring the Outcome of Biomedical Research: A Systematic Literature Review

    OpenAIRE

    Frédérique Thonon; Rym Boulkedid; Tristan Delory; Sophie Rousseau; Mahasti Saghatchian; Wim van Harten; Claire O'Neill; Corinne Alberti

    2015-01-01

    Background There is an increasing need to evaluate the production and impact of medical research produced by institutions. Many indicators exist, yet we do not have enough information about their relevance. The objective of this systematic review was (1) to identify all the indicators that could be used to measure the output and outcome of medical research carried out in institutions and (2) enlist their methodology, use, positive and negative points. Methodology We have searched 3 databases ...

  10. Hippocampal volume in relation to clinical and cognitive outcome after electroconvulsive therapy in depression

    Science.gov (United States)

    Nordanskog, P; Larsson, M R; Larsson, E-M; Johanson, A

    2014-01-01

    Objective In a previous magnetic resonance imaging (MRI) study, we found a significant increase in hippocampal volume immediately after electroconvulsive therapy (ECT) in patients with depression. The aim of this study was to evaluate hippocampal volume up to 1 year after ECT and investigate its possible relation to clinical and cognitive outcome. Method Clinical and cognitive outcome in 12 in-patients with depression receiving antidepressive pharmacological treatment referred for ECT were investigated with the Montgomery–Asberg Depression Rating Scale (MADRS) and a broad neuropsychological test battery within 1 week before and after ECT. The assessments were repeated 6 and 12 months after baseline in 10 and seven of these patients, respectively. Hippocampal volumes were measured on all four occasions with 3 Tesla MRI. Results Hippocampal volume returned to baseline during the follow-up period of 6 months. Neither the significant antidepressant effect nor the significant transient decrease in executive and verbal episodic memory tests after ECT could be related to changes in hippocampal volume. No persistent cognitive side effects were observed 1 year after ECT. Conclusion The immediate increase in hippocampal volume after ECT is reversible and is not related to clinical or cognitive outcome. PMID:23745780

  11. Our clinical experience on laparoscopic splenectomy: Outcomes of 38 patients

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    Zübeyir Bozdağ

    2015-12-01

    Full Text Available Objective: Laparoscopic splenectomy has gained widespread acceptance in the treatment of hematological diseases in recent years. In this study, we aimed to present the outcomes of the patients who underwent laparoscopic splenectomy. Methods: Between 2012 and 2015, the data of 38 patients, who underwent laparoscopic splenectomy for hematological diseases at our clinic, were evaluated retrospectively. Results: 15 males and 23 females patients were underwent laparoscopic splenectomy, and the average age was 33.9 ± 12.9 years. Indications for splenectomy were idiopathic thrombocytopenic purpura (ITP in 34 patients, and hereditary spherocytosis in 4 patients. During the surgical exploration, accessory spleen was detected in 7 patients, and removed. Laparoscopic cholecystectomy was performed at the same session in 2 hereditary spherocytosis patients who had stones in the gallbladder. One patient was converted to the open surgery due to the bleeding which was eliminated the exposure during the dissection. At the postoperative period, we observed atelectasis in one patient, and wound fat necrosis in one patient. In addition, thrombocytosis was observed in one patient. Hematological treatment was continued because of persistent refractory thrombocytopenia in two patients, and temporary thrombocytopenia in four patients. An accessory spleen was detected with splenic scintigraphy in one of these patients at the postoperative period. The average hospitalization time was 2.6 ± 0.7 days. Conclusion: Laparoscopic splenectomy for hematological diseases may be considered as first-line therapy with less hospital stay and morbidity.

  12. PERFORATED PEPTIC ULCER: A CLINICAL ANALYSIS AND OUTCOME

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    Bijit

    2016-03-01

    Full Text Available BACKGROUND The incidence of perforated peptic ulcer is approximately 7-10 cases per one lakh population per year. Perforation is seen in about 7% of patients hospitalized for peptic ulcer disease. Peptic ulcer perforation, which can be gastric/duodenal perforation can be a serious life-threatening condition if not detected early and treated urgently. Peptic ulcer disease has decreased considerably worldwide with the advent of potent anti-ulcer medicines, but its complication like peptic ulcer perforation has not. Our study is to analyse the clinical, radiological and management related findings in influencing the outcome of patients of peptic ulcer perforation after surgery. MATERIALS AND METHODS A series of 47 patients of peptic ulcer perforation were evaluated. Patients expiring within six hours of admission were not included in this study. RESULTS Age of the patients ranged from 17-80 years. The incidence of perforation was highest in the age group of 41-50 years (31.9%. Out of 47 patients, 41 (87.2% survived. CONCLUSION The incidence of perforation was highest in the age group of 41-50 years. Prognosis becomes poor with age, delayed treatment, shock at admission and concomitant diseases. Direct repair of the perforation with pedicled omentum gave excellent results.

  13. Spinal epidural angiolipomas: Clinical characteristics, management and outcomes

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    Bouali, Sofiene; Maatar, Nidhal; Bouhoula, Asma; Abderrahmen, Khansa; Said, Imed Ben; Boubaker, Adnen; Kallel, Jalel; Jemel, Hafedh

    2016-01-01

    Purpose: The spinal epidural angiolipomas are rare expansive processes made of mature lipomatous and angiomatous elements. They often have a benign character. Their etiology, pathogenesis remains uncertain, and it is a cause of spinal cord compression. The magnetic resonance imaging is the most important neuroradiological examination. Histological examination is the only examination to confirm the diagnosis. Surgery is the treatment of choice. Methods: A retrospective study of all patients operated on for a spinal epidural angiolipoma at the Department of Neurosurgery at the National Institute of Neurology of Tunis between January 2000 and December 2014 (15 years) was performed. The aim of this study is to describe the clinical, radiological, histological characteristics and the treatment of this tumor. Results: A total of nine patients were operated from January 01, 2000 to November 30, 2014. The average age of our patients was 51 years with ages that ranged from 29 to 65 with a male predominance. The period between onset of symptoms and diagnosis ranged from 24 months with an average 12 months. Posterior localization of the tumor was seen in all patients. Surgical resection was performed for all cases. The postoperative course has been satisfactory, with a complete recovery of neurological functions in all patients. Conclusions: The spinal epidural angiolipomas is rare expansive process causing spinal cord compression. Treatment is exclusively surgical resection. The functional outcome of spinal epidural angiolipomas is particularly favorable with a complete neurological recovery is if the patient was quickly operated. PMID:27695535

  14. Autogenic training: a meta-analysis of clinical outcome studies.

    Science.gov (United States)

    Stetter, Friedhelm; Kupper, Sirko

    2002-03-01

    Autogenic training (AT) is a self-relaxation procedure by which a psychophysiological determined relaxation response is elicited. A meta-analysis was performed to evaluate the clinical effectiveness of AT. Seventy-three controlled outcome studies were found (published 1952-99). Sixty studies (35 randomized controlled trials [RCT]) qualified for inclusion in the meta-analysis. Medium-to-large effect sizes (ES) occurred for pre-post comparisons of disease-specific AT-effects, with the RCTs showing larger ES. When AT was compared to real control conditions, medium ES were found. Comparisons of AT versus other psychological treatment mostly resulted in no effects or small negative ES. This pattern of results was stable at follow-up. Unspecific AT-effects (i.e., effects on mood, cognitive performance, quality of life, and physiological variables) tended to be even larger than main effects. Separate meta-analyses for different disorders revealed a significant reduction of the heterogeneity of ES. Positive effects (medium range) of AT and of AT versus control in the meta-analysis of at least 3 studies were found for tension headache/migraine, mild-to-moderate essential hypertension, coronary heart disease, asthma bronchiale, somatoform pain disorder (unspecified type), Raynaud's disease, anxiety disorders, mild-to-moderate depression/dysthymia, and functional sleep disorders.

  15. Clinical Outcomes of Acute Renal Failure in Children

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    Osman Dönmez

    2009-09-01

    Full Text Available Aim: The aim of this study was to investigate the etiological factors, clinical progression and management of acute renal failure (ARF in hospitalized children. Materials and Method: Medical records of 63 patients aged between 1 month and 18 years who were hospitalized at Uludag University, Department of Pediatrics or at various intensive care departments of the faculty and diagnosed with ARF between January 2005 and August 2006 were retrospectively analyzed. Results: Forty two of study patients were male and 21 were female. Mean age was 5.4±5.3 years. ARF was found in 4.9% of all hospitalized patients. Sepsis was the most frequent etiological factor with a ratio of 23.8%; which was followed by gastroenteritis (19.1%, tumor lysis syndrome (17.4% and cardiac surgery (15.9%. Oliguria, sepsis, hyperkalemia, acidosis and dialysis were found to be associated with increased mortality (p<0.05. The mortality rate in the study population was 49.2%.Conclusion: Dialysis and mechanical ventilation was found to be associated with a poor outcome in our patients. (Journal of Current Pediatrics 2009; 7: 57-61

  16. Clinic continuity of care, clinical outcomes and direct costs for COPD in Sweden: a population based cohort study

    Science.gov (United States)

    Sveréus, Sofia; Larsson, Kjell; Rehnberg, Clas

    2017-01-01

    ABSTRACT Introduction: In this study we investigate whether clinic level continuity of care (COC) for individuals with chronic obstructive pulmonary disease (COPD) is associated with better health care outcomes and lower costs in a Swedish setting. Methods: Individuals with COPD (N = 20,187) were identified through ICD-10 codes in all Stockholm County health care registries in 2007–2011 (59% female, 40% in the age group 65–74 years). We followed the individuals prospectively for 365 days after their first outpatient visit in 2012. Individual associations between COC and incidence of any hospitalization or emergency department visit and total costs for health care and pharmaceuticals were quantified by regression analysis, controlling for age, sex, comorbidity and number of visits. Clinic level COC was measured through the Bice–Boxerman COC index, grouped into quintiles. Results: At baseline, 26% of the individuals had been hospitalized at least once and 73% had dispensed at least seven prescription drugs (23% at least 16) in the last year. Patients in the lowest COC quintile (Q1) had higher probabilities of any hospitalization and any emergency department visit compared to those in Q5 (odds ratio 2.17 [95% CI 1.95–2.43] and 2.06 [1.86–2.28], respectively). Patients in Q1 also on average had 58% [95% CI: 52–64] higher costs. Conclusion: The findings show robust associations between clinic level COC and outcomes. These results verify the importance of COC, and suggest that clinic level COC is of relevance to both better outcomes for COPD patients and more efficient use of resources. PMID:28326179

  17. Clinical outcomes and mortality in elderly peritoneal dialysis patients

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    Tamer Sakacı

    2015-05-01

    Full Text Available OBJECTIVES: To evaluate the clinical outcomes and identify the predictors of mortality in elderly patients undergoing peritoneal dialysis. METHODS: We conducted a retrospective study including all incident peritoneal dialysis cases in patients ≥65 years of age treated from 2001 to 2014. Demographic and clinical data on the initiation of peritoneal dialysis and the clinical events during the study period were collected. Infectious complications were recorded. Overall and technique survival rates were analyzed. RESULTS: Fifty-eight patients who began peritoneal dialysis during the study period were considered for analysis, and 50 of these patients were included in the final analysis. Peritoneal dialysis exchanges were performed by another person for 65% of the patients, whereas 79.9% of patients preferred to perform the peritoneal dialysis themselves. Peritonitis and catheter exit site/tunnel infection incidences were 20.4±16.3 and 24.6±17.4 patient-months, respectively. During the follow-up period, 40 patients were withdrawn from peritoneal dialysis. Causes of death included peritonitis and/or sepsis (50% and cardiovascular events (30%. The mean patient survival time was 38.9±4.3 months, and the survival rates were 78.8%, 66.8%, 50.9% and 19.5% at 1, 2, 3 and 4 years after peritoneal dialysis initiation, respectively. Advanced age, the presence of additional diseases, increased episodes of peritonitis, the use of continuous ambulatory peritoneal dialysis, and low albumin levels and daily urine volumes (<100 ml at the initiation of peritoneal dialysis were predictors of mortality. The mean technique survival duration was 61.7±5.2 months. The technique survival rates were 97.9%, 90.6%, 81.5% and 71% at 1, 2, 3 and 4 years, respectively. None of the factors analyzed were predictors of technique survival. CONCLUSIONS: Mortality was higher in elderly patients. Factors affecting mortality in elderly patients included advanced age, the presence of

  18. Staff attitudes and the associations with treatment organisation, clinical practices and outcomes in opioid maintenance treatment

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    Gossop Michael

    2010-07-01

    Full Text Available Abstract Background In opioid maintenance treatment (OMT there are documented treatment differences both between countries and between OMT programmes. Some of these differences have been associated with staff attitudes. The aim of this study was to 1 assess if there were differences in staff attitudes within a national OMT programme, and 2 investigate the associations of staff attitudes with treatment organisation, clinical practices and outcomes. Methods This study was a cross-sectional multicentre study. Norwegian OMT staff (n = 140 were invited to participate in this study in 2007 using an instrument measuring attitudes towards OMT. The OMT programme comprised 14 regional centres. Data describing treatment organisation, clinical practices and patient outcomes in these centres were extracted from the annual OMT programme assessment 2007. Centres were divided into three groups based upon mean attitudinal scores and labelled; "rehabilitation-oriented", "harm reduction-oriented" and "intermediate" centres. Results All invited staff (n = 140 participated. Staff attitudes differed between the centres. "Rehabilitation-oriented" centres had smaller caseloads, more frequent urine drug screening and increased case management (interdisciplinary meetings. In addition these centres had less drug use and more social rehabilitation among their patients in terms of long-term living arrangements, unemployment, and social security benefits as main income. "Intermediate" centres had the lowest treatment termination rate. Conclusions This study identified marked variations in staff attitudes between the regional centres within a national OMT programme. These variations were associated with measurable differences in caseload, intensity of case management and patient outcomes.

  19. Early clinical outcome with a new monofocal microincision intraocular lens.

    Science.gov (United States)

    Toygar, Baha; Yabas Kiziloglu, Ozge; Toygar, Okan; Hacimustafaoglu, Ali Murat

    2016-10-01

    The purpose of this study was to evaluate the early visual and refractive outcomes of a new aspheric monofocal microincision intraocular lens (IOL). This retrospective case series included eyes of patients who underwent implantation of a microincision IOL following 1.8 mm manual coaxial microincision cataract surgery and who attended regular postoperative follow-up visits on the first week and first, third, and sixth months. The postoperative uncorrected visual acuity (UCVA), best corrected visual acuity (BCVA), refraction and predictability, intraoperative and postoperative complications, posterior capsule opacification (PCO), IOL centration, and surgically induced astigmatism (SIA) were evaluated. Sixty-three eyes of 38 patients ranging in age from 51 to 86 were included in the study. The mean preoperative BCVA was 0.52 ± 0.42 logMAR. At the postoperative sixth month, the mean postoperative UCVA and BCVA were 0.12 ± 0.11 and 0.01 ± 0.03 logMAR, respectively. The mean postoperative spherical equivalent refraction (SER) was -0.30 ± 0.49 D. The SER was within ± 1.00 D of the attempted correction in 95.2 % of the eyes. The mean SIA measured with vector analysis was 0.45 ± 0.28 D. Mild PCO was observed in 9 eyes (14.7 %) with none requiring Nd:Yag laser capsulotomy. On centration analysis, the IOL was found to be 0.26 mm on average to the supero-nasal position. The aspheric microincision IOL was safely implanted and provided satisfactory visual and refractive outcomes in the early postoperative period.

  20. A Comparison of Comorbidity Measurements to Control for Confounding in Health Outcomes Studies

    Science.gov (United States)

    2005-08-01

    OF PHARMACY [ 006 A Comparison of Comorbidity Measurements to Control for Confounding in Health Outcomes Studies JOEL F. FARLEY, B.S. PHARMACYA D•.;h... Joel F. Farley, R.Ph., University of Minnesota, College of Pharmacy, 7-174 Weaver-Densford Hall, 308 Harvard St. S.E., Minneapolis, MN 55455 Email...Hall RE, Rosen AK, Ash AS, Moskowitz MA. Searching for an improved clinical comorbidity index for use with ICD-9-CM administrative data. J Clin Epidemiol

  1. Clinical profile and outcome of posterior reversible encephalopathy syndrome (PRES

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    Virendra C Patil

    2015-01-01

    Full Text Available Background: Posterior reversible encephalopathy syndrome (PRES is a clinico-radiographic syndrome of multiple etiologies. Still, the exact pathophysiology of PRES is not clear. Aims and Objectives: To study demographic, etiological, and clinic-radiological profiles of patients presenting with PRES and their outcome at the tertiary care teaching hospital. Materials and Methods: A retrospective observational and non-interventional study was conducted at tertiary care center in from January 2009 to December 2013 at Krishna Institute of Medical Sciences, Karad. Inclusion Criteria: The clinical history of acute neurologic change including headache, encephalopathy, seizure, visual disturbance, or focal deficit with magnetic resonance imaging (MRI brain imaging findings of focal vasogenic edema with clinical or radiologic proof of reversibility. Results: Of a total 43 patients with suspected diagnosis of PRES, 29 patients were included fulfilling all inclusion criteria of PRES. Of total the 29 patients with confirmed diagnosis of PRES, 22 (75.86% were female and 7 (24.13% were male patients, predominated by female population (relative risk [RR]: 3.14; odds ration [OR]: 9.87; ′P′ < 0.001. The overall mean age was 33.65 years (±15.26 and mean duration of stay was 10.13 days (±4.98. The most common clinical presentation was generalized tonic-clonic seizures, seen in 23 (79.31% patients, headache in 21 (72.41% patients, and visual disturbances 13 (44.82% patients. A total of 18 (62.06% patients were hypertensive and 11 (37.93% were normotensive [RR: 1.63]. A total of 6 (27.27% females and 5 (71.42% males were normotensive and total 16 (72.72% females and 2 (28.57% males were hypertensive (RR: 1.12. Of a total of 22 female patients with PRES, 19 (86.36% were in a postpartum state, one (4.45% had systemic lupus erythematous (SLE, one (4.54% had community-acquired pneumonia (CAP with acute respiratory distress syndrome (ARDS with septicemia and one (4

  2. CORRELATION BETWEEN OBESITY, SAGITTAL BALANCE AND CLINICAL OUTCOME IN SPINAL FUSION

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    Marcel Machado da Motta

    2015-09-01

    Full Text Available Objective:To correlate obesity with radiographic parameters of spinal and spinopelvic balance in patients undergoing spinal arthrodesis, and to correlate obesity with clinical outcome of these patients.Methods:Observational retrospective study including patients who underwent spinal arthrodesis, with minimum follow-up period of three months. We measured waist circumference, as well as height and weight to calculate body mass index (BMI and obtained radiographs of the total column. The clinical parameters studied were pain by visual analog scale (VAS and the Oswestry questionnaire (ODI. Obesity correlated with radiographic parameters of the sagittal and spinopelvic balance and postoperative clinical parameters.Results:32 patients were analyzed. The higher the BMI, the greater the value of VAS found, but without statistical significance (p=0.83. There was also no correlation between BMI and the ODI questionnaire. Analyzing the abdominal circumference, there was no correlation between the VAS and ODI. There was no correlation between BMI or waist circumference and the radiographic parameters of global spinopelvic sagittal alignment. Regarding the postoperative results, there was no correlation between the mean BMI and waist circumference and the postoperative results for ODI and VAS (p=0.75 and p=0.7, respectively.Conclusions:The clinical outcomes of patients who undergone spinal fusion were not affected by the BMI and waist circumference. Also, there was no correlation between radiographic parameters of spinal and spinopelvic sagittal balance with obesity in patients previously treated with arthrodesis of the spine.

  3. Proton Radiotherapy for Parameningeal Rhabdomyosarcoma: Clinical Outcomes and Late Effects

    Energy Technology Data Exchange (ETDEWEB)

    Childs, Stephanie K. [Department of Radiation Oncology, Massachusetts General Hospital, Harvard Medical School, Boston, MA (United States); Kozak, Kevin R. [Department of Radiation Oncology, University of Wisconsin Cancer Center Johnson Creek, Madison, WI (United States); Friedmann, Alison M. [Department of Pediatric Oncology, Massachusetts General Hospital, Harvard Medical School, Boston, MA (United States); Yeap, Beow Y. [Department of Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, MA (United States); Adams, Judith; MacDonald, Shannon M.; Liebsch, Norbert J.; Tarbell, Nancy J. [Department of Radiation Oncology, Massachusetts General Hospital, Harvard Medical School, Boston, MA (United States); Yock, Torunn I., E-mail: tyock@partners.org [Department of Radiation Oncology, Massachusetts General Hospital, Harvard Medical School, Boston, MA (United States)

    2012-02-01

    Purpose: To report the clinical outcome and late side effect profile of proton radiotherapy in the treatment of children with parameningeal rhabdomyosarcoma (PM-RMS). Methods and Materials: Seventeen consecutive children with PM-RMS were treated with proton radiotherapy at Massachusetts General Hospital between 1996 and 2005. We reviewed the medical records of all patients and asked referring physicians to report specific side effects of interest. Results: Median patient age at diagnosis was 3.4 years (range, 0.4-17.6). Embryonal (n = 11), alveolar (n = 4), and undifferentiated (n = 2) histologies were represented. Ten patients (59%) had intracranial extension. Median prescribed dose was 50.4 cobalt gray equivalents (GyRBE) (range, 50.4-56.0 GyRBE) delivered in 1.8-2.0-GyRBE daily fractions. Median follow-up was 5.0 years for survivors. The 5-year failure-free survival estimate was 59% (95% confidence interval, 33-79%), and overall survival estimate was 64% (95% confidence interval, 37-82%). Among the 7 patients who failed, sites of first recurrence were local only (n = 2), regional only (n = 2), distant only (n = 2), and local and distant (n = 1). Late effects related to proton radiotherapy in the 10 recurrence-free patients (median follow-up, 5 years) include failure to maintain height velocity (n = 3), endocrinopathies (n = 2), mild facial hypoplasia (n = 7), failure of permanent tooth eruption (n = 3), dental caries (n = 5), and chronic nasal/sinus congestion (n = 2). Conclusions: Proton radiotherapy for patients with PM-RMS yields tumor control and survival comparable to that in historical controls with similar poor prognostic factors. Furthermore, rates of late effects from proton radiotherapy compare favorably to published reports of photon-treated cohorts.

  4. The clinical outcome of thymectomy in myasthenia gravis

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    Mirsharifi R

    2009-02-01

    Full Text Available "nBackground: Myasthenia Gravis (MG is a neuromuscular disorder with weakness of skeletal muscles. Thymectomy is now recognized as a treatment modality in MG. The aim of this study was to evaluate the clinical effect of thymectomy on MG. "nMethods: MG patients with history of thymectomy at a tertiary referral center during twelve year period were included. The medical records were reviewed and telephone survey was conducted to evaluate the effects of thymectomy. "nResults: Sixty MG patients, 46 females and 14 males, aged 30.4±11.1 years, underwent open (n=48 or video-assisted thoracoscopic thymectomy (n=12 during study period. The mean dosage of preoperative pyridostigmine was 235.4±86.2mg/day. This figure reached to 129±18mg/day after thymectomy (p<0.0001. 17 patients (28.3% had complete remission (complete freedom of symptoms without medications. Improve-ment (improved symptoms or less medication requirement was seen in 34 patients (56.6%. There was no response to surgical therapy in six patients (10%. Three patients (5% had experienced progression of disease postoperatively. Overall, benefit of thymectomy was observed in 85% of patients. Age, sex, duration and severity of disease, quantity of preoperative drugs, surgical approach, and presence of thymoma did not affect the outcome. Satisfaction was stated as excellent in 17%, good in 43%, moderate in 35% and poor in 5% of patients after operation. "nConclusion: Thymectomy is an effective treatment for MG which leads to less severity of disease and less drug requirement. It would be considered in all myasthenic patients regardless of age, sex, duration and severity of disease and presence of thymoma.

  5. Is magnetic resonance imaging reliable in predicting clinical outcome after articular cartilage repair of the knee?

    NARCIS (Netherlands)

    Windt, de T.S.; Welsch, G.H.; Brittberg, M.; Vonk, L.A.; Marlovits, S.; Trattnig, S.; Saris, D.B.F.

    2013-01-01

    Background: While MRI can provide a detailed morphological evaluation after articular cartilage repair, its additional value in determining clinical outcome has yet to be determined. Purpose: To evaluate the correlation between MRI and clinical outcome after cartilage repair and to identify parame

  6. Beta-blocker use and clinical outcomes after primary vascular surgery

    DEFF Research Database (Denmark)

    Høgh, A.; Lindholt, J.S.; Nielsen, Henrik

    2013-01-01

    To explore the associations between beta-blocker use and clinical outcomes (death, hospitalisation with myocardial infarction (MI) or stroke, major amputation and recurrent vascular surgery) after primary vascular reconstruction.......To explore the associations between beta-blocker use and clinical outcomes (death, hospitalisation with myocardial infarction (MI) or stroke, major amputation and recurrent vascular surgery) after primary vascular reconstruction....

  7. Influence of cell quality on clinical outcome after autologous chondrocyte implantation

    DEFF Research Database (Denmark)

    Niemeyer, Philipp; Pestka, Jan M; Salzmann, Gian M;

    2012-01-01

    BACKGROUND: Several factors influence clinical outcome after autologous chondrocyte implantation (ACI) for the treatment of cartilage defects of the knee joint. HYPOTHESIS/PURPOSE: The aim of the present study was to investigate the influence of cell quality on clinical outcome after ACI. The hyp...

  8. Brucellosis in pregnancy: clinical aspects and obstetric outcomes

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    Gustavo Vilchez

    2015-09-01

    Conclusions: This is the largest series of brucellosis in pregnancy reported in the literature. Brucella presents adverse obstetric outcomes including fetal and maternal/neonatal death. Cases with unexplained spontaneous abortion should be investigated for brucellosis. Prompt treatment is paramount to decrease the devastating outcomes.

  9. Impact of tofacitinib on patient outcomes in rheumatoid arthritis – review of clinical studies

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    Boyce EG

    2016-01-01

    Full Text Available Eric G Boyce, Deepti Vyas, Edward L Rogan, Cynthia S Valle-Oseguera, Kate M O'Dell Department of Pharmacy Practice, Thomas J Long School of Pharmacy and Health Sciences, University of the Pacific, Stockton, CA, USAAbstract: Rheumatoid arthritis is a chronic, progressive autoimmune disease associated with inflammation and destruction of joints and systemic effects, which result in significant impact on patient's quality of life and function. Tofacitinib was approved for the treatment of rheumatoid arthritis in the USA in 2012 and subsequently in other countries, but not by the European Medicines Agency. The goal of this review was to evaluate the impact of tofacitinib on patient-reported and patient-specific outcomes from prior clinical studies, focusing on quality of life, functionality, pain, global disease assessment, major adverse consequences, and withdrawals. A total of 13 reports representing 11 clinical studies on tofacitinib in rheumatoid arthritis were identified through PubMed and reference lists in meta-analyses and other reviews. Data on improvements in patient-driven composite tools to measure disease activity in rheumatoid arthritis, such as the Health Assessment Questionnaire, served as a major outcome evaluated in this review and were extracted from each study. Additional data extracted from those clinical studies included patient assessment of pain (using a 0–100 mm visual analog scale, patient global assessment of disease (using a 0–100 mm visual analog scale, patient withdrawals, withdrawals due to adverse effects or lack of effect, and risk of serious adverse effects, serious infections, and deaths. Tofacitinib 5 mg bid appears to have a favorable impact on patient outcomes related to efficacy and safety when compared with baseline values and with comparator disease-modifying antirheumatic drugs and placebo. Improvements were seen in the composite and individual measures of disease activity. Serious adverse effects, other

  10. The relationship between radiographic measurement and short-term clinical outcome of distal radius fractures%桡骨远端骨折影像学测量指标与近期疗效的关系

    Institute of Scientific and Technical Information of China (English)

    汤骏; 高伟阳; 徐华梓

    2008-01-01

    目的 通过对桡骨远端骨折患者的影像学测量,分析各影像学参数和近期疗效之间的关系.方法 对62例桡骨远端骨折闭合复位石膏外固定的患者,利用StarPACS影像系统进行测量,并记录所有患者X线片的桡骨高、掌倾角及尺偏角的情况,并分析影像学测量指标与自测腕关节功能之间的关系.结果 62例桡骨远端骨折中,有50例(占80.6%)经保守治疗后效果优良.当桡骨高大于6.0 mm,掌倾角大于5°,尺偏角大于18°时,自测腕关节功能优良率较高.影像学指标和自测腕关节功能的相关性桡骨高>掌倾角>尺偏角.结论 桡骨高、掌倾角及尺偏角等可以作为桡骨远端骨折治疗效果评估的影像学指标,手法复位后影像学不达标者应当重新复位或采用手术治疗,桡骨远端骨折时应当首先考虑桡骨高的恢复.%Objective To evaluate the relationship between radiographic measurement and short-term clinical omcome of distal radius fractures. Methotis Sixty-two cases of distal radius fractures treated with closed reduction and cast immobilization were involved in the study.The X-ray films were measured in the StarPACS system to acquire radial shortening,palmar tilt and radial inclination.The relationshiD between radiographic measurements and short-term wrist joint function was analyzed. Results Fifty out of 62 (80.6%)cases achieved good results.Better wrist joint function was observed when radial shortening was greater than 6.0 mm,palmar tilt greater than 5°and radial inclination greater than 18°.The correlation between radiographic measurement and wrist function Was tightest for radius shortening,followed by palmar tilt and radial inclination. Conclusion Radial shortening,palmar tilt and radial inclination can be used as radiographic criteria for evluating results in the treatment of distal radius fractures.If these criteria are not met after manual reduction,re-manipulation or surreal intervention should

  11. Addressing electronic clinical information in the construction of quality measures.

    Science.gov (United States)

    Bailey, L Charles; Mistry, Kamila B; Tinoco, Aldo; Earls, Marian; Rallins, Marjorie C; Hanley, Kendra; Christensen, Keri; Jones, Meredith; Woods, Donna

    2014-01-01

    Electronic health records (EHR) and registries play a central role in health care and provide access to detailed clinical information at the individual, institutional, and population level. Use of these data for clinical quality/performance improvement and cost management has been a focus of policy initiatives over the past decade. The Children's Health Insurance Program Reauthorization Act of 2009 (CHIPRA)-mandated Pediatric Quality Measurement Program supports development and testing of quality measures for children on the basis of electronic clinical information, including de novo measures and respecification of existing measures designed for other data sources. Drawing on the experience of Centers of Excellence, we review both structural and pragmatic considerations in e-measurement. The presence of primary observations in EHR-derived data make it possible to measure outcomes in ways that are difficult with administrative data alone. However, relevant information may be located in narrative text, making it difficult to interpret. EHR systems are collecting more discrete data, but the structure, semantics, and adoption of data elements vary across vendors and sites. EHR systems also differ in ability to incorporate pediatric concepts such as variable dosing and growth percentiles. This variability complicates quality measurement, as do limitations in established measure formats, such as the Quality Data Model, to e-measurement. Addressing these challenges will require investment by vendors, researchers, and clinicians alike in developing better pediatric content for standard terminologies and data models, encouraging wider adoption of technical standards that support reliable quality measurement, better harmonizing data collection with clinical work flow in EHRs, and better understanding the behavior and potential of e-measures.

  12. Measures of outcome in metastatic breast cancer: insights from a real-world scenario.

    Science.gov (United States)

    Bonotto, Marta; Gerratana, Lorenzo; Poletto, Elena; Driol, Pamela; Giangreco, Manuela; Russo, Stefania; Minisini, Alessandro M; Andreetta, Claudia; Mansutti, Mauro; Pisa, Federica E; Fasola, Gianpiero; Puglisi, Fabio

    2014-06-01

    No gold standard treatment exists for metastatic breast cancer (MBC). Clinical decision making is based on knowledge of prognostic and predictive factors that are extrapolated from clinical trials and, sometimes, are not reliably transferable to a real-world scenario. Moreover, misalignment between endpoints used in drug development and measures of outcome in clinical practice has been noted. The roles of overall survival (OS) and progression-free survival (PFS) as primary endpoints in the context of clinical trials are the subjects of lively debate. Information about these parameters in routine clinical practice is potentially useful to design new studies and/or to interpret the results of clinical research. This study analyzed the impact of patient and tumor characteristics on the major measures of outcome across different lines of treatment in a cohort of 472 patients treated for MBC. OS, PFS, and postprogression survival (PPS) were analyzed. The study showed how biological and clinical characteristics may have different prognostic value across different lines of therapy for MBC. After first-line treatment, the median PPS of luminal A, luminal B, and human epidermal growth factor receptor 2 (HER2)-positive groups was longer than 12 months. The choice of OS as a primary endpoint for clinical trials could not be appropriate with these subtypes. In contrast, OS could be an appropriate endpoint when PPS is expected to be low (e.g., triple-negative subtype after the first line; other subtypes after the third line). The potential implications of these findings are clinical and methodological.

  13. Cystic fibrosis and the role of gastrointestinal outcome measures in the new era of therapeutic CFTR modulation.

    Science.gov (United States)

    Bodewes, Frank A J A; Verkade, Henkjan J; Taminiau, Jan A J M; Borowitz, Drucy; Wilschanski, Michael

    2015-03-01

    With the development of new drugs that directly affect CFTR protein function, clinical trials are being designed or initiated for a growing number of patients with cystic fibrosis. The currently available and accepted clinical endpoints, FEV1 and BMI, have limitations. The aim of this report is to draw attention to the need and the ample possibilities for the development and validation of relevant gastrointestinal clinical endpoints for scientific evaluation of CFTR modulation treatment, particularly in young children and infants. The gastrointestinal tract offers very good opportunities to measure CFTR protein function and systematically evaluate CF related clinical outcomes based on the principal clinical gastrointestinal manifestations of CF: intestinal pH, intestinal transit time, intestinal bile salt malabsorption, intestinal inflammation, exocrine pancreatic function and intestinal fat malabsorption. We present a descriptive analysis of a variety of gastrointestinal outcome measures for clinical relevance, reliability, validity, responsiveness to interventions, feasibility in particular in young children and the availability of reference values.

  14. ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION: CLINICAL OUTCOMES OF PATELLA TENDON AND HAMSTRING TENDON GRAFTS

    Directory of Open Access Journals (Sweden)

    Dawn T. Gulick

    2002-09-01

    Full Text Available An injury to the ACL can result in significant functional impairment. It has been estimated that more than 100,000 new ACL injuries occur each year. Surgeons employ numerous techniques for reconstruction of the ACL. Of critical importance is the source of the graft to replace the damaged ACL. The graft choices include autografts (the patient's own tissue, allografts (donor tendon, and synthetic/prosthetic ligaments. Tissue harvest sites for autografting include the middle third of the patella tendon, the quadriceps tendon, semitendinosus tendon, gracilis tendon, iliotibial band, tensor fascia lata, and the Achilles tendon. Selection of the type of graft material is predicated upon the tissue's ability to tolerate high levels of stress. Likewise, the clinical presentation and functional outcome is related to the graft material selected. This manuscript specifically examined the patella tendon and hamstring tendon grafts. Numerous manuscripts that studied the outcomes of these graft materials were compiled to help the clinician appreciate the advantages and disadvantages of each of the graft materials. Outcome measures such as thigh circumference, knee range of motion, isokinetic strength, knee stability, pain, and vertical jump/1-leg hop were incorporated. The purpose of this manuscript was to compare and contrast the clinical presentation of patients who underwent an ACL reconstruction using the patella tendon versus the hamstring tendons. This information can be valuable to the clinician when considering the rehabilitation protocol after ACL reconstruction

  15. Measurement of social participation outcomes in rehabilitation of veterans with traumatic brain injury

    Directory of Open Access Journals (Sweden)

    William Stiers, PhD

    2012-02-01

    Full Text Available Traumatic brain injury (TBI is a significant concern in the veteran population, and the Department of Veteran Affairs (VA has devoted substantial healthcare resources to the rehabilitation of veterans with TBI. Evaluating the outcomes of these rehabilitation activities requires measuring whether they meaningfully improve veterans’ lives, especially with regard to community and vocational participation, which are strongly linked to perceived quality of life. In January 2010, the VA Rehabilitation Research and Development Service convened an invitational conference focused on outcome measurement in rehabilitation with a specific focus on veterans’ community and vocational participation. This article reports on the working group, addressing the issues of conceptualizing and operationalizing such participation outcome measures for veterans with TBI; we discuss conceptual models of participation, review participation subdomains and their instruments of measurement, and identify current research issues and needs. Two avenues are identified for advancing participation measurement in veterans with TBI. First, we describe suggestions to facilitate the immediate implementation of participation measurement into TBI clinical practice and rehabilitation research within the VA healthcare system. Second, we describe recommendations for future VA research funding initiatives specific to improving the measurement of participation in veterans with TBI.

  16. Preoperative MRI findings predict two-year postoperative clinical outcome in lumbar spinal stenosis.

    Directory of Open Access Journals (Sweden)

    Pekka Kuittinen

    Full Text Available To study the predictive value of preoperative magnetic resonance imaging (MRI findings for the two-year postoperative clinical outcome in lumbar spinal stenosis (LSS.84 patients (mean age 63±11 years, male 43% with symptoms severe enough to indicate LSS surgery were included in this prospective observational single-center study. Preoperative MRI of the lumbar spine was performed with a 1.5-T unit. The imaging protocol conformed to the requirements of the American College of Radiology for the performance of MRI of the adult spine. Visual and quantitative assessment of MRI was performed by one experienced neuroradiologist. At the two-year postoperative follow-up, functional ability was assessed with the Oswestry Disability Index (ODI 0-100% and treadmill test (0-1000 m, pain symptoms with the overall Visual Analogue Scale (VAS 0-100 mm, and specific low back pain (LBP and specific leg pain (LP separately with a numeric rating scale from 0-10 (NRS-11. Satisfaction with the surgical outcome was also assessed.Preoperative severe central stenosis predicted postoperatively lower LP, LBP, and VAS when compared in patients with moderate central stenosis (p<0.05. Moreover, severe stenosis predicted higher postoperative satisfaction (p = 0.029. Preoperative scoliosis predicted an impaired outcome in the ODI (p = 0.031 and lowered the walking distance in the treadmill test (p = 0.001. The preoperative finding of only one stenotic level in visual assessment predicted less postoperative LBP when compared with patients having 2 or more stenotic levels (p = 0.026. No significant differences were detected between quantitative measurements and the patient outcome.Routine preoperative lumbar spine MRI can predict the patient outcome in a two-year follow up in patients with LSS surgery. Severe central stenosis and one-level central stenosis are predictors of good outcome. Preoperative finding of scoliosis may indicate worse functional ability.

  17. Measurement properties of patient-reported outcome measures (PROMS) in Patellofemoral Pain Syndrome: a systematic review.

    Science.gov (United States)

    Green, Andrew; Liles, Clive; Rushton, Alison; Kyte, Derek G

    2014-12-01

    This systematic review investigated the measurement properties of disease-specific patient-reported outcome measures used in Patellofemoral Pain Syndrome. Two independent reviewers conducted a systematic search of key databases (MEDLINE, EMBASE, AMED, CINHAL+ and the Cochrane Library from inception to August 2013) to identify relevant studies. A third reviewer mediated in the event of disagreement. Methodological quality was evaluated using the validated COSMIN (Consensus-based Standards for the Selection of Health Measurement Instruments) tool. Data synthesis across studies determined the level of evidence for each patient-reported outcome measure. The search strategy returned 2177 citations. Following the eligibility review phase, seven studies, evaluating twelve different patient-reported outcome measures, met inclusion criteria. A 'moderate' level of evidence supported the structural validity of several measures: the Flandry Questionnaire, Anterior Knee Pain Scale, Functional Index Questionnaire, Eng and Pierrynowski Questionnaire and Visual Analogue Scales for 'usual' and 'worst' pain. In addition, there was a 'Limited' level of evidence supporting the test-retest reliability and validity (cross-cultural, hypothesis testing) of the Persian version of the Anterior Knee Pain Scale. Other measurement properties were evaluated with poor methodological quality, and many properties were not evaluated in any of the included papers. Current disease-specific outcome measures for Patellofemoral Pain Syndrome require further investigation. Future studies should evaluate all important measurement properties, utilising an appropriate framework such as COSMIN to guide study design, to facilitate optimal methodological quality.

  18. Effect of sperm DNA fragmentation on clinical outcome of frozen-thawed embryo transfer and on blastocyst formation.

    Science.gov (United States)

    Ni, Wuhua; Xiao, Shiquan; Qiu, Xiufang; Jin, Jianyuan; Pan, Chengshuang; Li, Yan; Fei, Qianjin; Yang, Xu; Zhang, Liya; Huang, Xuefeng

    2014-01-01

    During the last decades, many studies have shown the possible influence of sperm DNA fragmentation on assisted reproductive technique outcomes. However, little is known about the impact of sperm DNA fragmentation on the clinical outcome of frozen-thawed embryo transfer (FET) from cycles of conventional in vitro fertilization (IVF) and intra-cytoplasmic sperm injection (ICSI). In the present study, the relationship between sperm DNA fragmentation (SDF) and FET clinical outcomes in IVF and ICSI cycles was analyzed. A total of 1082 FET cycles with cleavage stage embryos (C-FET) (855 from IVF and 227 from ICSI) and 653 frozen-thawed blastocyst transfer cycles (B-FET) (525 from IVF and 128 from ICSI) were included. There was no significant change in clinical pregnancy, biochemical pregnancy and miscarriage rates in the group with a SDF >30% compared with the group with a SDF ≤30% in IVF and ICSI cycles with C-FET or B-FET. Also, there was no significant impact on the FET clinic outcome in IVF and ICSI when different values of SDF (such as 10%, 20%, 25%, 35%, and 40%) were taken as proposed threshold levels. However, the blastulation rates were significantly higher in the SDF ≤30% group in ICSI cycle. Taken together, our data show that sperm DNA fragmentation measured by Sperm Chromatin Dispersion (SCD) test is not associated with clinical outcome of FET in IVF and ICSI. Nonetheless, SDF is related to the blastocyst formation in ICSI cycles.

  19. Effect of sperm DNA fragmentation on clinical outcome of frozen-thawed embryo transfer and on blastocyst formation.

    Directory of Open Access Journals (Sweden)

    Wuhua Ni

    Full Text Available During the last decades, many studies have shown the possible influence of sperm DNA fragmentation on assisted reproductive technique outcomes. However, little is known about the impact of sperm DNA fragmentation on the clinical outcome of frozen-thawed embryo transfer (FET from cycles of conventional in vitro fertilization (IVF and intra-cytoplasmic sperm injection (ICSI. In the present study, the relationship between sperm DNA fragmentation (SDF and FET clinical outcomes in IVF and ICSI cycles was analyzed. A total of 1082 FET cycles with cleavage stage embryos (C-FET (855 from IVF and 227 from ICSI and 653 frozen-thawed blastocyst transfer cycles (B-FET (525 from IVF and 128 from ICSI were included. There was no significant change in clinical pregnancy, biochemical pregnancy and miscarriage rates in the group with a SDF >30% compared with the group with a SDF ≤30% in IVF and ICSI cycles with C-FET or B-FET. Also, there was no significant impact on the FET clinic outcome in IVF and ICSI when different values of SDF (such as 10%, 20%, 25%, 35%, and 40% were taken as proposed threshold levels. However, the blastulation rates were significantly higher in the SDF ≤30% group in ICSI cycle. Taken together, our data show that sperm DNA fragmentation measured by Sperm Chromatin Dispersion (SCD test is not associated with clinical outcome of FET in IVF and ICSI. Nonetheless, SDF is related to the blastocyst formation in ICSI cycles.

  20. Transforming the Academic Faculty Perspective in Graduate Medical Education to Better Align Educational and Clinical Outcomes.

    Science.gov (United States)

    Wong, Brian M; Holmboe, Eric S

    2016-04-01

    The current health care delivery model continues to fall short in achieving the desired patient safety and quality-of-care outcomes for patients. And, until recently, an explicit acknowledgment of the role and influence of the clinical learning environment on professional development had been missing from physician-based competency frameworks. In this Perspective, the authors explore the implications of the insufficient integration of education about patient safety and quality improvement by academic faculty into the clinical learning environment in many graduate medical education (GME) programs, and the important role that academic faculty need to play to better align the educational and clinical contexts to improve both learner and patient outcomes. The authors propose a framework that closely aligns the educational and clinical contexts, such that both educational and clinical outcomes are centered around the patient. This will require a reorganization of academic faculty perspective and educational design of GME training programs that recognizes that (1) the dynamic interplay between the faculty, learner, training program, and clinical microsystem ultimately influences the quality of physician that emerges from the training program and environment, and (2) patient outcomes relate to the quality of education and the success of clinical microsystems. To enable this evolution, there is a need to revisit the core competencies expected of academic faculty, implement innovative faculty development strategies, examine closely faculty's current clinical super vision practices, and establish a training environment that supports bridging from clinician to educator, training program to clinical microsystem, and educational outcomes to clinical outcomes that benefit patients.

  1. Directly measured secondhand smoke exposure and COPD health outcomes

    Directory of Open Access Journals (Sweden)

    Balmes John

    2006-06-01

    Full Text Available Abstract Background Although personal cigarette smoking is the most important cause and modulator of chronic obstructive pulmonary disease (COPD, secondhand smoke (SHS exposure could influence the course of the disease. Despite the importance of this question, the impact of SHS exposure on COPD health outcomes remains unknown. Methods We used data from two waves of a population-based multiwave U.S. cohort study of adults with COPD. 77 non-smoking respondents with a diagnosis of COPD completed direct SHS monitoring based on urine cotinine and a personal badge that measures nicotine. We evaluated the longitudinal impact of SHS exposure on validated measures of COPD severity, physical health status, quality of life (QOL, and dyspnea measured at one year follow-up. Results The highest level of SHS exposure, as measured by urine cotinine, was cross-sectionally associated with poorer COPD severity (mean score increment 4.7 pts; 95% CI 0.6 to 8.9 and dyspnea (1.0 pts; 95% CI 0.4 to 1.7 after controlling for covariates. In longitudinal analysis, the highest level of baseline cotinine was associated with worse COPD severity (4.7 points; 95% CI -0.1 to 9.4; p = 0.054, disease-specific QOL (2.9 pts; -0.16 to 5.9; p = 0.063, and dyspnea (0.9 pts; 95% CI 0.2 to 1.6 pts; p Conclusion Directly measured SHS exposure appears to adversely influence health outcomes in COPD, independent of personal smoking. Because SHS is a modifiable risk factor, clinicians should assess SHS exposure in their patients and counsel its avoidance. In public health terms, the effects of SHS exposure on this vulnerable subpopulation provide a further rationale for laws prohibiting public smoking.

  2. Multigenerational Challenges: Team-Building for Positive Clinical Workforce Outcomes

    Science.gov (United States)

    Moore, Jill M; Everly, Marcee; Bauer, Renee

    2016-05-31

    Patient acuity in hospital settings continues to increase, and there is greater emphasis on patient outcomes. The current nursing workforce is comprised of four distinct generational cohorts that include veterans, baby boomers, millennials, and generation Xers. Each group has unique characteristics that add complexity to the workforce and this can add challenges to providing optimal patient care. Team building is one strategy to increase mutual understanding, communication, and respect, and thus potentially improve patient outcomes. In this article, we first briefly define generational cohorts by characteristics, and discuss differing expectations for work/life balance and potential negative outcomes. Our discussion offers team building strategies for positive outcomes, a case scenario, and concludes with resources for team building and organizational opportunities.

  3. An introduction to patient-reported outcome measures (PROMs) in physiotherapy.

    Science.gov (United States)

    Kyte, D G; Calvert, M; van der Wees, P J; ten Hove, R; Tolan, S; Hill, J C

    2015-06-01

    The use of patient-reported outcome measures (PROMs) is set to rise in physiotherapy. PROMs provide additional 'patient-centred' data which is unique in capturing the patient's own opinion on the impact of their disease or disorder, and its treatment, on their life. Thus, PROMs are increasingly used by clinicians to guide routine patient care, or for the purposes of audit, and are already firmly embedded in clinical research. This article seeks to summarise the key aspects of PROM use for physiotherapists, both in routine clinical practice and in the research setting, and highlights recent developments in the field. Generic and condition-specific PROMs are defined and examples of commonly used measures are provided. The selection of appropriate PROMs, and their effective use in the clinical and research settings is discussed. Finally, existing barriers to PROM use in practice are identified and recent physiotherapy PROM initiatives, led by the Royal Dutch Society for Physical Therapy are explored.

  4. Randomized clinical trial of small-incision and laparoscopic cholecystectomy in patients with symptomatic cholecystolithiasis: primary and clinical outcomes.

    NARCIS (Netherlands)

    Keus, F.; Werner, J.E.; Gooszen, H.G.; Oostvogel, H.J.M.; Laarhoven, C.J.H.M. van

    2008-01-01

    OBJECTIVE: To evaluate the primary and clinical outcomes in laparoscopic and small-incision cholecystectomy. DESIGN: Blinded randomized single-center trial emphasizing methodologic quality and generalizability. SETTING: General teaching hospital in the Netherlands. PATIENTS: A total of 257 patients

  5. Surgeon Reported Outcome Measure for Spine Trauma an International Expert Survey Identifying Parameters Relevant for The Outcome of Subaxial Cervical Spine Injuries

    NARCIS (Netherlands)

    Sadiqi, Said; Verlaan, Jorrit Jan; Lehr, A. M.; Dvorak, Marcel F.; Kandziora, Frank; Rajasekaran, S.; Schnake, Klaus J.; Vaccaro, Alexander R.; Oner, F. C.

    2016-01-01

    STUDY DESIGN.: International web-based survey OBJECTIVE.: To identify clinical and radiological parameters that spine surgeons consider most relevant when evaluating clinical and functional outcomes of subaxial cervical spine trauma patients. SUMMARY OF BACKGROUND DATA.: While an outcome instrument

  6. Clinical outcomes in pediatric hemodialysis patients in the USA: lessons from CMS' ESRD CPM Project.

    Science.gov (United States)

    Neu, Alicia M; Frankenfield, Diane L

    2009-07-01

    Although prospective randomized trials have provided important information and allowed the development of evidence-based guidelines in adult hemodialysis (HD) patients, with approximately 800 prevalent pediatric HD patients in the United States, such studies are difficult to perform in this population. Observational data obtained through the Center for Medicare & Medicaid Services' (CMS') End Stage Renal Disease (ESRD) Clinical Performance Measures (CPM) Project have allowed description of the clinical care provided to pediatric HD patients as well as identification of risk factors for failure to reach adult targets for clinical parameters such as hemoglobin, single-pool Kt/V (spKt/V) and serum albumin. In addition, studies linking data from the ESRD CPM Project and the United States Renal Data System have allowed evaluation of associations between achievement of those targets and the outcomes of hospitalization and death. The results of those studies, while unable to prove cause and effect, suggest that the adult ESRD CPM targets may assist in identifying pediatric HD patients at risk for poor outcomes.

  7. Paediatric Obsessive-Compulsive Disorder and Depressive Symptoms: Clinical Correlates and CBT Treatment Outcomes.

    Science.gov (United States)

    Brown, H M; Lester, K J; Jassi, A; Heyman, I; Krebs, G

    2015-07-01

    Depression frequently co-occurs with paediatric obsessive-compulsive disorder (OCD), yet the clinical correlates and impact of depression on CBT outcomes remain unclear. The prevalence and clinical correlates of depression were examined in a paediatric specialist OCD-clinic sample (N = 295; Mean = 15 [7 - 18] years, 42 % female), using both dimensional (Beck Depression Inventory-youth; n = 261) and diagnostic (Development and Wellbeing Assessment; n = 127) measures of depression. The impact of depressive symptoms and suspected disorders on post-treatment OCD severity was examined in a sub-sample who received CBT, with or without SSRI medication (N = 100). Fifty-one per-cent of patients reported moderately or extremely elevated depressive symptoms and 26 % (95 % CI: 18 - 34) met criteria for a suspected depressive disorder. Depressive symptoms and depressive disorders were associated with worse OCD symptom severity and global functioning prior to CBT. Individuals with depression were more likely to be female, have had a psychiatric inpatient admission and less likely to be attending school (ps CBT. Depressive symptoms and depressive disorders predicted worse post-treatment OCD severity (βs = 0.19 and 0.26, ps CBT for OCD and is not independently associated with worse outcomes, supporting the recommendation for treatment as usual in the presence of depressive symptoms.

  8. The role of perfectionism in cognitive behaviour therapy outcomes for clinically anxious children.

    Science.gov (United States)

    Mitchell, Jennifer H; Newall, Carol; Broeren, Suzanne; Hudson, Jennifer L

    2013-09-01

    The main aim of this study was to determine whether pre-treatment levels of child perfectionism impacted on anxiety treatment outcomes for school-aged children. In addition, it was investigated whether child perfectionism decreased following treatment for anxiety. Participants were sixty-seven clinically anxious children aged 6-13 years (female = 34; majority Caucasian) who were enrolled in a group-based cognitive behaviour therapy program, and their parents. They completed self-report questionnaires on anxiety and depressive symptoms and were administered a diagnostic interview to determine the type and clinician rated severity of anxiety and related disorders pre- and post-treatment and at 6-month follow-up. Self- and parent-rated perfectionism were also measured pre-treatment, while a subset of children completed perfectionism measures post-treatment as well. Self-Oriented Perfectionism, but not Socially Prescribed Perfectionism, predicted poorer self-reported treatment outcome (higher levels of anxiety symptoms) immediately following treatment and at 6-month follow-up when using a multi-informant approach. Additionally, both Self-Oriented and Socially Prescribed child perfectionism significantly reduced immediately following treatment. Despite reductions in child perfectionism following anxiety treatment, higher Self-Oriented Perfectionism may impact negatively on child anxiety treatment outcome.

  9. Patient-reported outcome measures in arthroplasty registries

    DEFF Research Database (Denmark)

    Rolfson, Ola; Bohm, Eric; Franklin, Patricia

    2016-01-01

    unsatisfied, dissatisfied, neutral, satisfied, or very satisfied). Survey logistics include patient instructions, paper- and electronic-based data collection, reminders for follow-up, centralized as opposed to hospital-based follow-up, sample size, patient- or joint-specific evaluation, collection intervals......The International Society of Arthroplasty Registries (ISAR) Patient-Reported Outcome Measures (PROMs) Working Group have evaluated and recommended best practices in the selection, administration, and interpretation of PROMs for hip and knee arthroplasty registries. The 2 generic PROMs in common use...... are the Short Form health surveys (SF-36 or SF-12) and EuroQol 5-dimension (EQ-5D). The Working Group recommends that registries should choose specific PROMs that have been appropriately developed with good measurement properties for arthroplasty patients. The Working Group recommend the use of a 1-item pain...

  10. Measuring the outcome of biomedical research: a systematic literature review.

    Directory of Open Access Journals (Sweden)

    Frédérique Thonon

    Full Text Available There is an increasing need to evaluate the production and impact of medical research produced by institutions. Many indicators exist, yet we do not have enough information about their relevance. The objective of this systematic review was (1 to identify all the indicators that could be used to measure the output and outcome of medical research carried out in institutions and (2 enlist their methodology, use, positive and negative points.We have searched 3 databases (Pubmed, Scopus, Web of Science using the following keywords: [Research outcome* OR research output* OR bibliometric* OR scientometric* OR scientific production] AND [indicator* OR index* OR evaluation OR metrics]. We included articles presenting, discussing or evaluating indicators measuring the scientific production of an institution. The search was conducted by two independent authors using a standardised data extraction form. For each indicator we extracted its definition, calculation, its rationale and its positive and negative points. In order to reduce bias, data extraction and analysis was performed by two independent authors.We included 76 articles. A total of 57 indicators were identified. We have classified those indicators into 6 categories: 9 indicators of research activity, 24 indicators of scientific production and impact, 5 indicators of collaboration, 7 indicators of industrial production, 4 indicators of dissemination, 8 indicators of health service impact. The most widely discussed and described is the h-index with 31 articles discussing it.The majority of indicators found are bibliometric indicators of scientific production and impact. Several indicators have been developed to improve the h-index. This indicator has also inspired the creation of two indicators to measure industrial production and collaboration. Several articles propose indicators measuring research impact without detailing a methodology for calculating them. Many bibliometric indicators identified

  11. Validation of GAITRite and PROMIS as high-throughput physical function outcome measures following ACL reconstruction.

    Science.gov (United States)

    Papuga, M Owen; Beck, Christopher A; Kates, Stephen L; Schwarz, Edward M; Maloney, Michael D

    2014-06-01

    New healthcare demands for quality measures of elective procedures, such as anterior cruciate ligament (ACL) reconstructive surgery, warrant the establishment of high throughput outcomes for high volume clinics. To this end, we evaluated the PROMIS and GAITRite as physical function outcome measures to quantify early healing and post-operative complications in 106 patients at pre-operative and 3, 10, 20 and 52 weeks post-ACL reconstruction with bone-tendon-bone autograft, and compared the results to the current IKDC validated outcome measure. The results showed that both PROMIS and GAITRite were significantly quicker to administer versus IKDC (pPROMIS and GAITRite detected a significant decrease in physical function at 3 weeks post-operative, and a significant improvement at 10 weeks post-operative versus pre-operative (pPROMIS and IKDC detected significant improvement out to 52 weeks post-operative (pPROMIS, with a combined correlation value of 0.8954 (pPROMIS is a diagnostic test for poor outcomes.

  12. Neurobrucellosis: clinical, diagnostic, therapeutic features and outcome. Unusual clinical presentations in an endemic region

    Directory of Open Access Journals (Sweden)

    Nurgul Ceran

    2011-02-01

    Full Text Available Brucellosis is a zoonotic infection and has endemic characteristics. Neurobrucellosis is an uncommon complication of this infection. The aim of this study was to present unusual clinical manifestations and to discuss the management and outcome of a series of 18 neurobrucellosis cases. Initial clinical manifestations consist of pseudotumor cerebri in one case, white matter lesions and demyelinating syndrome in three cases, intracranial granuloma in one case, transverse myelitis in two cases, sagittal sinus thrombosis in one case, spinal arachnoiditis in one case, intracranial vasculitis in one case, in addition to meningitis in all cases. Eleven patients were male and seven were female. The most prevalent symptoms were headache (83% and fever (44%. All patients were treated with rifampicin, doxycycline plus trimethoprim-sulfamethoxazole or ceftriaxone. Duration of treatment (varied 3-12 months was determined on basis of the CSF response. In four patients presented with left mild sequelae including aphasia, hearing loss, hemiparesis. In conclusion, although mortality is rare in neurobrucellosis, its sequelae are significant. In neurobrucellosis various clinical and neuroradiologic signs and symptoms can be confused with other neurologic diseases. In inhabitants or visitors of endemic areas, neurobrucellosis should be kept in mind in cases that have unusual neurological manifestations.

  13. Neurobrucellosis: clinical, diagnostic, therapeutic features and outcome. Unusual clinical presentations in an endemic region.

    Science.gov (United States)

    Ceran, Nurgul; Turkoglu, Recai; Erdem, Ilknur; Inan, Asuman; Engin, Derya; Tireli, Hulya; Goktas, Pasa

    2011-01-01

    Brucellosis is a zoonotic infection and has endemic characteristics. Neurobrucellosis is an uncommon complication of this infection. The aim of this study was to present unusual clinical manifestations and to discuss the management and outcome of a series of 18 neurobrucellosis cases. Initial clinical manifestations consist of pseudotumor cerebri in one case, white matter lesions and demyelinating syndrome in three cases, intracranial granuloma in one case, transverse myelitis in two cases, sagittal sinus thrombosis in one case, spinal arachnoiditis in one case, intracranial vasculitis in one case, in addition to meningitis in all cases. Eleven patients were male and seven were female. The most prevalent symptoms were headache (83%) and fever (44%). All patients were treated with rifampicin, doxycycline plus trimethoprim-sulfamethoxazole or ceftriaxone. Duration of treatment (varied 3-12 months) was determined on basis of the CSF response. In four patients presented with left mild sequelae including aphasia, hearing loss, hemiparesis. In conclusion, although mortality is rare in neurobrucellosis, its sequelae are significant. In neurobrucellosis various clinical and neuroradiologic signs and symptoms can be confused with other neurologic diseases. In inhabitants or visitors of endemic areas, neurobrucellosis should be kept in mind in cases that have unusual neurological manifestations.

  14. How can we improve clinical research in clinical practice with better research outcome?

    Science.gov (United States)

    Woo, Keng Thye; Wong, Kok Seng; Lee, Evan J C; Chan, Choong Meng

    2011-11-01

    This paper explains some of the difficulties doctors face when taking up a career in research. It describes the efforts by the government and the Ministry of Health (MOH) to nurture the Clinician Scientist Programme. The nature of research and the mindset of clinicians who are passionate about research are explored and the reasons which drive some of them to pursue a research career. It discusses the need to have structured training for research and how continuing research education is necessary for the researcher. The paper discusses the goals for research and how we can achieve better research outcomes and the importance of good mentorship. It suggests ways to engage more doctors in research in the restructured hospitals by overcoming some of the problems they encounter. Finally, it relates the Biomedical Science initiative of the government through the National Research Foundation and the various programmes in Translational Clinical Research available for clinicians who are keen on a research career.

  15. Diffuse optical measurements of head and neck tumor hemodynamics for early prediction of chemoradiation therapy outcomes

    Science.gov (United States)

    Dong, Lixin; Kudrimoti, Mahesh; Irwin, Daniel; Chen, Li; Kumar, Sameera; Shang, Yu; Huang, Chong; Johnson, Ellis L.; Stevens, Scott D.; Shelton, Brent J.; Yu, Guoqiang

    2016-08-01

    This study used a hybrid near-infrared diffuse optical instrument to monitor tumor hemodynamic responses to chemoradiation therapy for early prediction of treatment outcomes in patients with head and neck cancer. Forty-seven patients were measured once per week to evaluate the hemodynamic status of clinically involved cervical lymph nodes as surrogates for the primary tumor response. Patients were classified into two groups: complete response (CR) (n=29) and incomplete response (IR) (n=18). Tumor hemodynamic responses were found to be associated with clinical outcomes (CR/IR), wherein the associations differed depending on human papillomavirus (HPV-16) status. In HPV-16 positive patients, significantly lower levels in tumor oxygenated hemoglobin concentration ([HbO2]) at weeks 1 to 3, total hemoglobin concentration at week 3, and blood oxygen saturation (StO2) at week 3 were found in the IR group. In HPV-16 negative patients, significantly higher levels in tumor blood flow index and reduced scattering coefficient (μs‧) at week 3 were observed in the IR group. These hemodynamic parameters exhibited significantly high accuracy for early prediction of clinical outcomes, within the first three weeks of therapy, with the areas under the receiver operating characteristic curves (AUCs) ranging from 0.83 to 0.96.

  16. Cellular islet autoimmunity associates with clinical outcome of islet cell transplantation.

    Directory of Open Access Journals (Sweden)

    Volkert A L Huurman

    Full Text Available BACKGROUND: Islet cell transplantation can cure type 1 diabetes (T1D, but only a minority of recipients remains insulin-independent in the following years. We tested the hypothesis that allograft rejection and recurrent autoimmunity contribute to this progressive loss of islet allograft function. METHODOLOGY/PRINCIPAL FINDINGS: Twenty-one T1D patients received cultured islet cell grafts prepared from multiple donors and transplanted under anti-thymocyte globulin (ATG induction and tacrolimus plus mycophenolate mofetil (MMF maintenance immunosuppression. Immunity against auto- and alloantigens was measured before and during one year after transplantation. Cellular auto- and alloreactivity was assessed by lymphocyte stimulation tests against autoantigens and cytotoxic T lymphocyte precursor assays, respectively. Humoral reactivity was measured by auto- and alloantibodies. Clinical outcome parameters--including time until insulin independence, insulin independence at one year, and C-peptide levels over one year--remained blinded until their correlation with immunological parameters. All patients showed significant improvement of metabolic control and 13 out of 21 became insulin-independent. Multivariate analyses showed that presence of cellular autoimmunity before and after transplantation is associated with delayed insulin-independence (p = 0.001 and p = 0.01, respectively and lower circulating C-peptide levels during the first year after transplantation (p = 0.002 and p = 0.02, respectively. Seven out of eight patients without pre-existent T-cell autoreactivity became insulin-independent, versus none of the four patients reactive to both islet autoantigens GAD and IA-2 before transplantation. Autoantibody levels and cellular alloreactivity had no significant association with outcome. CONCLUSIONS/SIGNIFICANCE: In this cohort study, cellular islet-specific autoimmunity associates with clinical outcome of islet cell transplantation under ATG

  17. The significance of clinical experience on learning outcome from resuscitation training-a randomised controlled study

    DEFF Research Database (Denmark)

    Jensen, Morten Lind; Lippert, Freddy; Hesselfeldt, Rasmus

    2009-01-01

    and retention of learning. Materials and methods: This was a prospective single blinded randomised controlled study of the learning outcome from a standard ALS course on a volunteer sample of the entire cohort of newly graduated doctors from Copenhagen University. The outcome measurement was ALS...... a small but statistically significant impact on the retention of learning, but not on the immediate learning outcome....

  18. Thoracic outlet syndrome: do we have clinical tests as predictors for the outcome after surgery?

    Directory of Open Access Journals (Sweden)

    Sadeghi-Azandaryani M

    2009-09-01

    Full Text Available Abstract Objective Thoracic outlet syndrome (TOS is a clinical phenomenon resulting from compression of the neurovascular structures at the superior aperture of the thorax which presents with varying symptoms. Regarding to the varying symptoms, the diagnosis of TOS seems to be a challenge and predictors for the outcome are rare. The purpose of this study was therefore to analyze the different clinical examinations and tests relative to their prediction of the clinical outcome subsequent to surgery. Methods During a period of five years, 56 patients were diagnosed with TOS. Medical history, clinical tests, operative procedure and complications were recorded and analysed. Mean follow-up of the patients was 55.6 ± 45.5 months, median age of the patients was 36.4 ± 12.5 years. Results Different clinical tests for TOS showed an acceptable sensitivity overall, but a poor specificity. A positive test was not associated with a poor outcome. Analyses of the systolic blood pressure before and after exercise showed, that a distinct decrease in blood pressure of the affected side after exercises was associated with a poor outcome (p = 0.0027. Conclusions Clinical tests for TOS show a good sensitivity, but a poor specificity and cannot be used as predictors for the outcome. A distinct decrease in blood pressure of the affected side after exercises was associated with poor outcome and might be useful to predict the patients' outcome.

  19. Clinical characteristics and treatment outcomes of severe ulcerative colitis

    Institute of Scientific and Technical Information of China (English)

    詹翔

    2014-01-01

    Objective To explore the clinical characteristics and medicine treatment of patients with severe ulcerative colitis(UC),the efficacy of rescue treatment in patients with glucocorticoid(GCS)resistant severe UC,and the clinical risk factors in patients with GCS-refractory severe UC.Methods From January 2001 to December 2012,

  20. Outcome measures in physiotherapy management of patients with stroke: A survey into self-reported use, and barriers to and facilitators for use

    NARCIS (Netherlands)

    Peppen, R.P.S. van; Maissan, F.J.F.; Genderen, F.R. van; Dolder, R. van; Meeteren, N.L.U. van

    2008-01-01

    Objective. To investigate physiotherapists' self-reported use of outcome measures as recommended in the Dutch Clinical Practice Guideline on Physiotherapy Management of Patients with Stroke (CPGPS) and to assess perceived barriers to and facilitators for the use of outcome measures in everyday pract

  1. Reporting outcome measures of functional constipation in children from 0 to 4 years of age.

    Science.gov (United States)

    Kuizenga-Wessel, Sophie; Benninga, Marc A; Tabbers, Merit M

    2015-04-01

    Functional constipation (FC) often begins in the first year of life. Although standard definitions and criteria have been formulated to describe FC, these are rarely used in research and clinical practice. The aim of the study is to systematically assess how definitions and outcome measures are defined in therapeutic randomized controlled trials (RCTs) of infants with FC. PubMed, EMBASE, and Cochrane databases were searched. Studies were included if it was a (systematic review of) therapeutic RCT, children ≤4 years old, they had FC, a clear definition of constipation was provided, and were written in English. Quality was assessed using the Delphi list. A total of 1115 articles were found; only 5 studies fulfilled the inclusion criteria. Four different definitions were used, of which only 2 used the internationally accepted Rome III criteria. Defecation frequency was used as primary outcome in all included trials and stool consistency in 3 trials. Two trials involving infants investigated new infant formulas, whereas the third RCT evaluated the efficacy of a probiotic strain. The 2 trials including infants up to 4 years of age compared polyethylene glycol without electrolytes (PEG4000) with lactulose and milk of magnesia. All of the trials used nonvalidated parental diaries. Different definitions and outcome measures for FC in infants are used in RCTs. Disappointingly, there is a lack of well-designed therapeutic trials in infants with constipation. To make comparison between future trials possible, standard definitions, core outcomes, and validated instruments are needed.

  2. Clinical Features and Outcome in Newly Diagnosed Hodgkin Lymphoma Patients Presenting with PET/CT-Ascertained Focal Skeletal Lesions

    DEFF Research Database (Denmark)

    El-Galaly, Tarec Christoffer; Hutchings, Martin; Juul Mylam, Karen;

    Clinical Features and Outcome in Newly Diagnosed Hodgkin Lymphoma Patients Presenting with PET/CT-Ascertained Focal Skeletal Lesions......Clinical Features and Outcome in Newly Diagnosed Hodgkin Lymphoma Patients Presenting with PET/CT-Ascertained Focal Skeletal Lesions...

  3. A tool for evaluating the potential for cost-effective outcomes measurement

    Directory of Open Access Journals (Sweden)

    Somasekhar MM

    2012-04-01

    Full Text Available Melinda M Somasekhar1, Alfred Bove2, Chris Rausch1, James Degnan3, Cathy T King1, Arnold Meyer11The Albert J Finestone, MD, Office for Continuing Medical Education, 2Section of Cardiology, Temple University School of Medicine, Philadelphia, PA, USA; 3Measurement and Research Center, Temple University, Philadelphia, PA, USAAbstract: Cost related to higher-level outcomes measurement is often very high. However, the cost burden is felt even more by smaller, less well-funded continuing medical education (CME programs. It is possible to overcome financial and participant-related barriers to measuring Level 6 outcomes, which are patient health outcomes. The Temple University School of Medicine’s Office for Continuing Medical Education developed a sequential tool for attaining cost-effective outcomes measurement for determining the likelihood of a CME intervention to produce significant changes in physician performance. The appropriate selection of the CME topic and specific practice change indictors drive this tool. This tool walks providers through a simple YES or NO decision-making list that guides them toward an accurate prediction of potential programmatic outcomes. Factors considered during the decision-making process include whether: (a the intended change(s will have a substantial impact on current practice; (b the intended practice change(s are well supported by clinical data, specialty organization/government recommendations, expert opinion, etc; (c the potential change(s affects a large population; (d external factors, such as system pressures, media pressures, financial pressures, patient pressures, safety pressures, etc, are driving this intended change in performance; (e there is a strong motivation on the part of physicians to implement the intended change(s; and (f the intended change(s is relatively easy to implement within any system of practice. If each of these questions can be responded to positively, there is a higher likelihood

  4. Clinical applicability of nursing outcomes in the evolution of orthopedic patients with Impaired Physical Mobility

    Directory of Open Access Journals (Sweden)

    Marcos Barragan da Silva

    2015-02-01

    Full Text Available AIM: to evaluate the clinical applicability of outcomes, according to the Nursing Outcomes Classification (NOC in the evolution of orthopedic patients with Impaired Physical MobilityMETHOD: longitudinal study conducted in 2012 in a university hospital, with 21 patients undergoing Total Hip Arthroplasty, evaluated daily by pairs of trained data collectors. Data were collected using an instrument containing five Nursing Outcomes, 16 clinical indicators and a five point Likert scale, and statistically analyzed.RESULTS: The outcomes Body Positioning: self-initiated, Mobility, Knowledge: prescribed activity, and Fall Prevention Behavior presented significant increases in mean scores when comparing the first and final evaluations (p<0.001 and (p=0.035.CONCLUSION: the use of the NOC outcomes makes it possible to demonstrate the clinical progression of orthopedic patients with Impaired Physical Mobility, as well as its applicability in this context.

  5. Classification of non-aneurysmal subarachnoid haemorrhage: CT correlation to the clinical outcome

    Energy Technology Data Exchange (ETDEWEB)

    Nayak, S., E-mail: sanjeevnayak@hotmail.co [Department of Neuroradiology, University Hospital of North Staffordshire, North Staffordshire Royal Infirmary, Princes Road, Stoke-on-Trent, Staffordshire, ST4 7LN (United Kingdom); Kunz, A.B.; Kieslinger, K. [University Clinic of Neurology, Paracelsus Medical University Salzburg (Austria); Ladurner, G.; Killer, M. [University Clinic of Neurology, Paracelsus Medical University Salzburg (Austria); Neuroscience Institute, Christian Doppler Clinic, Paracelsus Medical University Salzburg (Austria)

    2010-08-15

    Aim: To propose a new computed tomography (CT)-based classification system for non-aneurysmal subarachnoid haemorrhage (SAH), which predicts patients' discharge clinical outcome and helps to prioritize appropriate patient management. Methods and materials: A 5-year, retrospective, two-centre study was carried out involving 1486 patients presenting with SAH. One hundred and ninety patients with non-aneurysmal SAH were included in the study. Initial cranial CT findings at admission were correlated with the patients' discharge outcomes measured using the Modified Rankin Scale (MRS). A CT-based classification system (type 1-4) was devised based on the topography of the initial haemorrhage pattern. Results: Seventy-five percent of the patients had type 1 haemorrhage and all these patients had a good clinical outcome with a discharge MRS of {<=}1. Eight percent of the patients presented with type 2 haemorrhage, 62% of which were discharged with MRS of {<=}1 and 12% of patients had MRS 3 or 4. Type 3 haemorrhage was found in 10%, of which 16% had good clinical outcome, but 53% had moderate to severe disability (MRS 3 and 4) and 5% were discharged with severe disability (MRS 5). Six percent of patients presented with type 4 haemorrhage of which 42% of the patients had moderate to severe disability (MRS 3 and 4), 42% had severe disability and one-sixth of the patients died. Highly significant differences were found between type 1(1a and 1b) and type 2 (p = 0.003); type 2 and type 3 (p = 0.002); type 3 and type 4 (p = 0.001). Conclusion: Haemorrhages of the type 1 category are usually benign and do not warrant an extensive battery of clinical and radiological investigations. Type 2 haemorrhages have a varying prognosis and need to be investigated and managed along similar lines as that of an aneurysmal haemorrhage with emphasis towards radiological investigation. Type 3 and type 4 haemorrhages need to be extensively investigated to find an underlying cause.

  6. Clinical outcome of pediatric collagenous gastritis: case series and review of literature.

    Science.gov (United States)

    Hijaz, Nadia Mazen; Septer, Seth Steven; Degaetano, James; Attard, Thomas Mario

    2013-03-07

    Collagenous gastritis (CG) is characterized by patchy subepithelial collagen bands. Effective treatment and the clinical and histological outcome of CG in children are poorly defined. The aim of this study is to summarize the published literature on the clinical outcome and response to therapy of pediatric CG including two new cases. We performed a search in Pubmed, OVID for related terms; articles including management and clinical and/or endo-histologic follow up information were included and abstracted. Reported findings were pooled in a dedicated database including the corresponding data extracted from chart review in our patients with CG. Twenty-four patients were included (17 females) with a mean age of 11.7 years. The clinical presentation included iron deficiency anemia and dyspepsia. The reported duration of follow up (in 18 patients) ranged between 0.2-14 years. Despite most subjects presenting with anemia including one requiring blood transfusion, oral iron therapy was only documented in 12 patients. Other treatment modalities were antisecretory measures in 13 patients; proton pump inhibitors (12), or histamine-2 blockers (3), sucralfate (5), prednisolone (6), oral budesonide in 3 patients where one received it in fish oil and triple therapy (3). Three (13%) patients showed no clinical improvement despite therapy; conversely 19 out of 22 were reported with improved symptoms including 8 with complete symptom resolution. Spontaneous clinical resolution without antisecretory, anti-inflammatory or gastroprotective agents was noted in 5 patients (4 received only supplemental iron). Follow up endo-histopathologic data (17 patients) included persistent collagen band and stable Mononuclear cell infiltrate in 12 patients with histopathologic improvement in 5 patients. Neither collagen band thickness nor mononuclear cell infiltrate correlated with clinical course. Intestinal metaplasia and endocrine cell hyperplasia were reported (1) raising the concern of long

  7. A psychometric analysis of outcome measures in peripheral spondyloarthritis

    Science.gov (United States)

    Turina, Maureen C; Baeten, Dominique L; Mease, Philip; Paramarta, Jacqueline E; Song, In-Ho; Pangan, Aileen L; Landewé, Robert

    2016-01-01

    Objectives To assess the discriminatory capacity of various outcome measures and response criteria in patients with peripheral spondyloarthritis (pSpA). Methods Data originated from two randomised controlled trials, ABILITY-2 and Tnf Inhibition in PEripheral SpondyloArthritis (TIPES). Continuous outcome measures included patient's global assessment (PGA)/physician's global assessment of disease (PhGA), C-reactive protein (CRP), tender joint counts (TJC)/swollen joint counts (SJC), Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), and the Ankylosing Spondylitis Disease Activity Score (ASDAS). Dichotomous response criteria included Peripheral SpondyloArthritis Response Criteria (PSpARC), American College of Rheumatology (ACR), ASDAS and BASDAI response criteria. The capacity to discriminate between adalimumab and placebo groups was assessed by standardised mean differences (SMD) for continuous variables, and Pearson's χ2 for dichotomous response criteria. Results Within each trial, the composite indices for axial SpA assessment, ASDAS-CRP (SMD: −0.63 and −0.89 in ABILITY-2 and the TIPES trial, respectively) and BASDAI (SMD: −0.50 and −0.73), and the single-item measures PGA (SMD: −0.47 and −1.12) and PhGA (SMD: −0.64 and −0.87) performed better than other single-item measures, such as CRP (SMD: −0.18 and −0.53), SJC or TJC. In general, the PSpARC and ACR response criteria discriminated better than ASDAS and BASDAI response criteria. Conclusions The axial SpA-specific ASDAS-CRP and BASDAI, but also PGA and PhGA, demonstrated good discriminatory ability in patients with pSpA. The pSpA-specific pSpARC response criteria and the rheumatoid arthritis-specific ACR response criteria also discriminated well. To fully capture typical pSpA manifestations, it may be worth developing new pSpA-specific indices with better performance and face validity. Trial registration numbers ABILITY-2: NCT01064856; TIPES: EUDRACT 2008-006885-27. PMID:26245756

  8. Knee shape might predict clinical outcome after an anterior cruciate ligament rupture.

    Science.gov (United States)

    Eggerding, V; van Kuijk, K S R; van Meer, B L; Bierma-Zeinstra, S M A; van Arkel, E R A; Reijman, M; Waarsing, J H; Meuffels, D E

    2014-06-01

    We have investigated whether shape of the knee can predict the clinical outcome of patients after an anterior cruciate ligament rupture. We used statistical shape modelling to measure the shape of the knee joint of 182 prospectively followed patients on lateral and Rosenberg view radiographs of the knee after a rupture of the anterior cruciate ligament. Subsequently, we associated knee shape with the International Knee Documentation Committee subjective score at two years follow-up. The mean age of patients was 31 years (21 to 51), the majority were male (n = 121) and treated operatively (n = 135). We found two modes (shape variations) that were significantly associated with the subjective score at two years: one for the operatively treated group (p = 0.002) and one for the non-operatively treated group (p = 0.003). Operatively treated patients who had higher subjective scores had a smaller intercondylar notch and a smaller width of the intercondylar eminence. Non-operatively treated patients who scored higher on the subjective score had a more pyramidal intercondylar notch as opposed to one that was more dome-shaped. We conclude that the shape of the femoral notch and the intercondylar eminence is predictive of clinical outcome two years after a rupture of the anterior cruciate ligament.

  9. Manual function outcome measures in children with developmental coordination disorder (DCD): Systematic review.

    Science.gov (United States)

    Bieber, Eleonora; Smits-Engelsman, Bouwien C M; Sgandurra, Giuseppina; Cioni, Giovanni; Feys, Hilde; Guzzetta, Andrea; Klingels, Katrijn

    2016-08-01

    This study systematically reviewed the clinical and psychometric properties of manual function outcome measures for children with developmental coordination disorder (DCD) aged 3-18 years. Three electronic databases were searched to identify manual function tools at the ICF-CY body function, activity and participation level used in children with DCD. Study selection and data extraction was conducted by two blind assessors according to the CanChild Outcome Measures Rating Form. Nineteen clinical tests (seven fine hand use tools and 12 handwriting measures), three naturalistic observations and six questionnaires were identified. The fine-motor subdomain of the Movement Assessment Battery for Children, the Bruininks-Oseretsky Test of Motor Proficiency-2 and the Functional Strength Measurement, with adequate reliability and validity properties, might be useful for manual function capacity assessment. The Systematic Detection of Writing Problems (SOS) and the Detailed Assessment of Speed of Handwriting (DASH) could be adopted for handwriting assessment, respectively from 6 and 9 years old. Naturalistic observations and questionnaires, whose psychometric properties have been investigated into limited extent, offer an assessment of the daily performances. This review shows that a combination of different tools is needed for a comprehensive assessment of manual function in children with DCD including the three levels of the ICF-CY. Further investigation of psychometric properties of those tools in children with DCD is warranted. Tests validated in other populations should be explored for their applicability for assessing manual function in children with DCD.

  10. Clinical outcome, proteome kinetics and angiogenic factors in serum after thermoablation of colorectal liver metastases

    NARCIS (Netherlands)

    Wertenbroek, Marieke W. J. L. A. E.; Schepers, Marianne; Kamminga-Rasker, Hannetta J.; Bottema, Jan T.; Kobold, Anneke C. Muller; Roelofsen, Han; de Jong, Koert P.

    2013-01-01

    Background: Thermoablation is used to treat patients with unresectable colorectal liver metastases (CRLM). We analyze clinical outcome, proteome kinetics and angiogenic markers in patients treated by cryosurgical ablation (CSA) or radiofrequency ablation (RFA). Methods: 205 patients underwent CSA (n

  11. Deteriorated clinical outcome in coronary artery disease patients with a high prevalence of Porphyromonas gingivalis infection

    Directory of Open Access Journals (Sweden)

    Daisuke Tezuka

    2016-06-01

    Conclusions: P. gingivalis was identified by sensitive detection in patients with CAD, diagnosed by coronary CTA. P. gingivalis in oral saliva can be a potential marker which is associated with clinical outcomes in patients with CAD.

  12. The influence of neck thrombus on clinical outcome and aneurysm morphology after endovascular aneurysm repair

    NARCIS (Netherlands)

    Goncalves, Frederico Bastos; Verhagen, Hence J. M.; Chinsakchai, Khamin; van Keulen, Jasper W.; Voute, Michiel T.; Zandvoort, Herman J.; Moll, Frans L.; van Herwaarden, Joost A.

    2012-01-01

    Objective: This study investigated the influence of significant aneurysm neck thrombus in clinical and morphologic outcomes after endovascular aneurysm repair (EVAR). Methods: The patient population was derived from a prospective EVAR database from two university institutions in The Netherlands from

  13. Management and clinical outcomes in patients treated with apixaban vs warfarin undergoing procedures

    NARCIS (Netherlands)

    Garcia, D.; Alexander, J.H.; Wallentin, L.; Wojdyla, D.M.; Thomas, L.; Hanna, M.; Al-Khatib, S.M.; Dorian, P.; Ansell, J.; Commerford, P.; Flaker, G.; Lanas, F.; Vinereanu, D.; Xavier, D.; Hylek, E.M.; Held, C.; Verheugt, F.W.; Granger, C.B.; Lopes, R.D.

    2014-01-01

    Using data from ARISTOTLE, we describe the periprocedural management of anticoagulation and rates of subsequent clinical outcomes among patients chronically anticoagulated with warfarin or apixaban. We recorded whether (and for how long) anticoagulant therapy was interrupted preprocedure, whether br

  14. Zoonotic bacterial meningitis in adults: clinical characteristics, etiology, treatment and outcome

    NARCIS (Netherlands)

    van Samkar, A.

    2016-01-01

    In this thesis, we describe the clinical characteristics, etiology, treatment and outcome of zoonotic bacterial meningitis. Each chapter describes meningitis patients infected by a specific zoonotic pathogen, such as Streptococcus equi, Streptococcuis suis, Capnocytophaga canimorsus, Campylobacter f

  15. A qualitative study of stakeholder views of the conditions for and outcomes of successful clinical networks

    Directory of Open Access Journals (Sweden)

    McInnes Elizabeth

    2012-02-01

    Full Text Available Abstract Background Clinical networks have been established to improve health outcomes and processes of care by implementing a range of innovations and undertaking projects based on perceived local need. Limited research exists on the necessary conditions required to bring about successful network outcomes and what characterises network success from the perspective of those involved in network initiatives. This qualitative study identified stakeholder views on i the conditions for effective clinical networks; and ii desirable outcomes of successful clinical networks. Methods Twenty-seven participants were interviewed using face-to-face audio-recorded semi-structured interviews. Transcribed data were coded and analysed to generate themes relating to the study aims. Results Five key factors represented as sub-themes were identified as important conditions for the establishment of successful clinical networks under the main theme of effective network structure, organisation and governance. These were: building relationships; effective leadership; strategic evidence-based workplans; adequate resources; and ability to implement and evaluate network initiatives. Two major themes encapsulated views on desirable outcomes of successful clinical networks: connecting and engaging which represented the outcomes of interdisciplinary and consumer collaboration and, partnerships with state health and local health services, and changing the landscape of care, which represented the importance of outcomes associated with improving services, care and patient health outcomes and implementing evidence-based practice. Conclusions This study provides new knowledge on the conditions needed to establish successful clinical networks and on desirable outcomes arising from network projects and initiatives that are considered to be valuable by those working in or associated with clinical networks. This provides health services with information on what needs to be in place

  16. CLINICAL HISTORY AND OUTCOME OF 59 PATIENTS WITH IDIOPATHIC HYPERPROLACTINEMIA

    NARCIS (Netherlands)

    SLUIJMER, AV; LAPPOHN, RE

    1992-01-01

    Objective: To investigate the clinical course of hyperprolactinemia without demonstrable cause. Design: Prospective study of all patients with idiopathic hyperprolactinemia first seen between 1974 and 1985. Setting: Outpatient Department of University Hospital. Patients: Fifty-nine patients followed

  17. ABO blood groups and malaria related clinical outcom

    OpenAIRE

    Deepa, Vanamala A. Alwar, Karuna Rameshkumar & Cecil Ross

    2011-01-01

    Objectives: The study was undertaken to correlate the blood groups and clinical presentations in malaria patientsand to understand the differential host susceptibility in malaria.Methods: From October 2007 to September 2008, malaria positive patients’ samples were evaluated in thisstudy. Hemoglobin, total leukocyte count, and platelet count of each patient were done on an automated cellcounter. After determining the blood groups, malarial species and the severity of clinical course were corr...

  18. ST-Segment resolution and clinical outcome with ischemic postconditioning and comparison to magnetic resonance

    DEFF Research Database (Denmark)

    Lønborg, Jacob; Holmvang, Lene; Kelbæk, Henning;

    2010-01-01

    Ischemic postconditioning (IPost) during primary percutaneous coronary intervention (PPCI) is suggested to reduce myocardial damage. However, the association with ST-segment resolution (STR) and clinical outcome is not determined. The primary aim of this study was to evaluate the association of I...... of IPost with STR and clinical outcome. Secondly, we sought to determine the relationship between STR and cardiac magnetic resonance (CMR) parameters in these patients....

  19. Patient-specific instrumentation does not improve radiographic alignment or clinical outcomes after total knee arthroplasty.

    Science.gov (United States)

    Huijbregts, Henricus J T A M; Khan, Riaz J K; Sorensen, Emma; Fick, Daniel P; Haebich, Samantha

    2016-08-01

    Background and purpose - Patient-specific instrumentation (PSI) for total knee arthroplasty (TKA) has been introduced to improve alignment and reduce outliers, increase efficiency, and reduce operation time. In order to improve our understanding of the outcomes of patient-specific instrumentation, we conducted a meta-analysis. Patients and methods - We identified randomized and quasi-randomized controlled trials (RCTs) comparing patient-specific and conventional instrumentation in TKA. Weighted mean differences and risk ratios were determined for radiographic accuracy, operation time, hospital stay, blood loss, number of surgical trays required, and patient-reported outcome measures. Results - 21 RCTs involving 1,587 TKAs were included. Patient-specific instrumentation resulted in slightly more accurate hip-knee-ankle axis (0.3°), coronal femoral alignment (0.3°, femoral flexion (0.9°), tibial slope (0.7°), and femoral component rotation (0.5°). The risk ratio of a coronal plane outlier (> 3° deviation of chosen target) for the tibial component was statistically significantly increased in the PSI group (RR =1.64). No significance was found for other radiographic measures. Operation time, blood loss, and transfusion rate were similar. Hospital stay was significantly shortened, by approximately 8 h, and the number of surgical trays used decreased by 4 in the PSI group. Knee Society scores and Oxford knee scores were similar. Interpretation - Patient-specific instrumentation does not result in clinically meaningful improvement in alignment, fewer outliers, or better early patient-reported outcome measures. Efficiency is improved by reducing the number of trays used, but PSI does not reduce operation time.

  20. Redesigning a clinical mentoring program for improved outcomes in the clinical training of clerks

    Directory of Open Access Journals (Sweden)

    Chia-Der Lin

    2015-09-01

    Full Text Available Introduction: Mentorship has been noted as critical to medical students adapting to clinical training in the medical workplace. A lack of infrastructure in a mentoring program might deter relationship building between mentors and mentees. This study assessed the effect of a redesigned clinical mentoring program from the perspective of clerks. The objective was to assess the benefits of the redesigned program and identify potential improvements. Methods: A redesigned clinical mentoring program was launched in a medical center according to previous theoretical and practical studies on clinical training workplaces, including the elements of mentor qualifications, positive and active enhancers for mentor–mentee relationship building, the timing of mentoring performance evaluation, and financial and professional incentives. A four-wave web survey was conducted, comprising one evaluation of the former mentoring program and three evaluations of the redesigned clinical mentoring program. Sixty-four fifth-year medical students in clerkships who responded to the first wave and to at least two of the three following waves were included in the study. A structured and validated questionnaire encompassing 15 items on mentor performance and the personal characteristics of the clerks was used. Mixed linear models were developed for repeated measurements and to adjust for personal characteristics. Results: The results revealed that the redesigned mentoring program improved the mentors’ performance over time for most evaluated items regarding professional development and personal support provided to the mentees. Conclusions: Our findings serve as an improved framework for the role of the institution and demonstrate how institutional policies, programs, and structures can shape a clinical mentoring program. We recommend the adoption of mentorship schemes for other cohorts of medical students and for different learning and training stages involved in becoming a

  1. Quantifying prosthetic gait deviation using simple outcome measures

    Science.gov (United States)

    Kark, Lauren; Odell, Ross; McIntosh, Andrew S; Simmons, Anne

    2016-01-01

    AIM: To develop a subset of simple outcome measures to quantify prosthetic gait deviation without needing three-dimensional gait analysis (3DGA). METHODS: Eight unilateral, transfemoral amputees and 12 unilateral, transtibial amputees were recruited. Twenty-eight able-bodied controls were recruited. All participants underwent 3DGA, the timed-up-and-go test and the six-minute walk test (6MWT). The lower-limb amputees also completed the Prosthesis Evaluation Questionnaire. Results from 3DGA were summarised using the gait deviation index (GDI), which was subsequently regressed, using stepwise regression, against the other measures. RESULTS: Step-length (SL), self-selected walking speed (SSWS) and the distance walked during the 6MWT (6MWD) were significantly correlated with GDI. The 6MWD was the strongest, single predictor of the GDI, followed by SL and SSWS. The predictive ability of the regression equations were improved following inclusion of self-report data related to mobility and prosthetic utility. CONCLUSION: This study offers a practicable alternative to quantifying kinematic deviation without the need to conduct complete 3DGA. PMID:27335814

  2. Comparison of microsurgery and endovascular treatment on clinical outcome following poor-grade subarachnoid hemorrhage.

    Science.gov (United States)

    Sandström, Niklas; Yan, Bernard; Dowling, Richard; Laidlaw, John; Mitchell, Peter

    2013-09-01

    Poor-grade (World Federation of Neurological Surgeons [WFNS] clinical grading scale grades IV and V) subarachnoid hemorrhage (SAH) is associated with significant morbidity and mortality. However, the correlation between the timing, modality of intervention (clipping or coiling) and the clinical outcome is not clear. This study aims to examine this correlation. Patients presenting with WFNS grades IV and V aneurysmal SAH between 1997 and 2008 to a single centre were studied. An aggressive policy of early intervention was followed, and the selection of endovascular versus microsurgical intervention was made according to angiographic rather than clinical features. Clinical outcomes were graded using the modified Rankin scale (mRS) at 6 month follow-up. One hundred and forty-three poor-grade patients (23.9% of all 598 aneurysmal SAH patients) were studied. Treatment was microsurgical in 83 (58.0%) and endovascular in 60 (42%) patients. Twenty patients (14.0%) were lost to follow-up. Good outcome (mRS 0-2) at 6 months was found in 45 microsurgical patients (63.3%) and 24 endovascular patients (46.1%). This trend towards better clinical outcomes in the microsurgical group was not statistically significant. With an aggressive early treatment policy more than half of the poor-grade SAH patients demonstrated a good clinical outcome. Microsurgery and endovascular treatment, when selected primarily according to angiographic features, were equally likely to achieve good outcome.

  3. Psychometric validation of patient-reported outcome measures assessing chronic constipation

    Directory of Open Access Journals (Sweden)

    Nelson LM

    2014-09-01

    Full Text Available Lauren M Nelson,1 Valerie SL Williams,1 Sheri E Fehnel,1 Robyn T Carson,2 James MacDougall,3 Mollie J Baird,3 Stavros Tourkodimitris,2 Caroline B Kurtz,3 Jeffrey M Johnston31RTI Health Solutions, Durham, NC, USA; 2Forest Research Institute, Jersey City, NJ, USA; 3Ironwood Pharmaceuticals, Cambridge, MA, USABackground: Measures assessing treatment outcomes in previous CC clinical trials have not met the requirements described in the US Food and Drug Administration's guidance on patient-reported outcomes.Aim: Psychometric analyses using data from one Phase IIb study and two Phase III trials of linaclotide for the treatment of chronic constipation (CC were conducted to document the measurement properties of patient-reported CC Symptom Severity Measures.Study methods: Each study had a multicenter, randomized, double-blind, placebo-controlled, parallel-group design, comparing placebo to four doses of oral linaclotide taken once daily for 4 weeks in the Phase IIb dose-ranging study (n=307 and to two doses of linaclotide taken once daily for 12 weeks in the Phase III trials (n=1,272. The CC Symptom Severity Measures addressing bowel function (Bowel Movement Frequency, Stool Consistency, Straining and abdominal symptoms (Bloating, Abdominal Discomfort, Abdominal Pain were administered daily using interactive voice-response system technology. Intraclass correlations, Pearson correlations, factor analyses, F-tests, and effect sizes were computed.Results: The CC Symptom Severity Measures demonstrated satisfactory test–retest reliability and construct validity. Factor analyses indicated one factor for abdominal symptoms and another for bowel symptoms. Known-groups F-tests substantiated the discriminating ability of the CC Symptom Severity Measures. Responsiveness statistics were moderate to strong, indicating that these measures are capable of detecting change.Conclusion: In large studies of CC patients, linaclotide significantly improved abdominal and

  4. Cardiac asthma in elderly patients: incidence, clinical presentation and outcome

    Directory of Open Access Journals (Sweden)

    Ray Patrick

    2007-05-01

    Full Text Available Abstract Background Cardiac asthma is common, but has been poorly investigated. The objective was to compare the characteristics and outcome of cardiac asthma with that of classical congestive heart failure (CHF in elderly patients. Methods Prospective study in an 1,800-bed teaching hospital. Results Two hundred and twelve consecutive patients aged ≥ 65 years presenting with dyspnea due to CHF (mean age of 82 ± 8 years were included. Findings of cardiac echocardiography and natriuretic peptides levels were used to confirm CHF. Cardiac asthma patients were defined as a patient with CHF and wheezing reported by attending physician upon admission to the emergency department. The CHF group (n = 137 and the cardiac asthma group (n = 75, differed for tobacco use (34% vs. 59%, p 2 (47 ± 15 vs. 41 ± 11 mmHg, p Conclusion Patients with cardiac asthma represented one third of CHF in elderly patients. They were more hypercapnic and experienced more distal airway obstruction. However, outcomes were similar.

  5. A CLINICAL STUDY OF OUTCOME OF LABOUR IN TRANSVERSE LIE

    Directory of Open Access Journals (Sweden)

    Vijayalakshmi

    2015-08-01

    Full Text Available Transverse lie complicates approximately 0.5% of birth and may result in neglected or impacted shoulder presentation leading to obstructed labour, rupture uterus and postpartum haemorrhage which may result in death of the mother, if not adequately managed in labour . A prospective observational study done in VI MS B ellary, Karnataka, aim of the study was to know the maternal and fetal outcome, to study caesarean rate, maternal and neonatal complications following caesarean. Objective of the study is to analyse the various modes of outcome of transverse lie to kno w the fetal and maternal mortality and morbidity , to improve the conditions which decreases these rates and guide us for better management of these cases. Out of 6116 deliveries100 cases were transverse lie during 2year period from April 1999 to January 20 01. Out of 100 cases , 76 were caesarean sections, 48 were live births, 7 were neonatal deaths, 45 were still births. Maternal morbidity was 2 cases required subtotal hysterectomy. There were no maternal deaths. Elective caesarean section should be advised in all booked cases with transverse lie at term, after ruling out congenital anomalies of the fetus by anomaly scan.

  6. Clinical measurement of mechanical ankle instability.

    Science.gov (United States)

    Parasher, Raju K; Nagy, Dawn R; Em, April L; Phillips, Howard J; Mc Donough, Andrew L

    2012-10-01

    Clinicians commonly use the anterior draw test (ligament laxity) and distal fibular position (lateral malleolus displacement), to measure ankle instability. The purpose of this study was to establish intra-rater and inter-rater reliability for the anterior draw test and distal fibular position in a clinical setting. The anterior draw test (AD) was measured with a plastic Goniometer, and was defined as the linear displacement of the foot as it is drawn anteriorly with the ankle held in 20 degrees of plantar-flexion. Distal fibular position (DFP) was measured in standing using a digital vernier caliper and was the relative linear distance between the lateral and the medial malleoli. 20 participants aged 21-28 volunteered for the study and were measured on both ankles. It was found that Intra-tester reliability (ICC) ranged from 0.88 to 0.97 for AD and DFP; while inter-tester reliability (ICC) was 0.6 for AD and 0.77 for DFP. In addition for measures across trials, the standard error of the measurement (SEM) was, on average 0.66 mm for AD and 1.7 mm for DFP. While the limits of agreement (LOA) was ±0.17 mm for AD and ±4.03 mm for DFP. However, the SEM and LOA between testers was 2.27 mm and ±2.27 mm respectively for AD; and for 3.1 mm and ±10.4 mm for DFP. Overall the results suggest that both measures, as defined in this study exhibit moderate to good reliability and low standard error of measurement, suggesting a high degree of repeatability across trials.

  7. Using Cross-Cultural Dimensions Exercises to Improve and Measure Learning Outcomes in International Business Courses

    Science.gov (United States)

    Zainuba, Mohamed; Rahal, Ahmad

    2012-01-01

    This article proposes an approach for using cross-cultural dimensions exercises to improve and measure learning outcomes in international business courses. The following key issues are highlighted: (a) what are the targeted learning outcomes to be assessed, (b) how to measure the accomplishment of these learning outcomes, (c) the input measures…

  8. Clinical characteristics and outcome of intracerebral hemorrhage in young adults

    NARCIS (Netherlands)

    Rutten-Jacobs, L.C.A.; Maaijwee, N.A.M.M.; Arntz, R.M.; Schoonderwaldt, H.C.; Dorresteijn, L.D.A.; Dijk, E.J. van; Leeuw, F.E. de

    2014-01-01

    Data on determinants of prognosis after intracerebral hemorrhage (ICH) in young adults are scarce. Our aim was to identify clinical determinants of prognosis after ICH in adults aged 18-50. We investigated 98 consecutive patients with an ICH, aged 18-50 years, admitted to our hospital between 1980 a

  9. Longitudinal assessment of pain outcomes in the clinical setting: development of the "APOLO" electronic data capture system.

    Science.gov (United States)

    Hassett, Afton L; Wasserman, Ronald; Goesling, Jenna; Rakovitis, Kevin; Shi, Baorong; Brummett, Chad M

    2012-01-01

    Data to fully evaluate the effectiveness of many commonly used interventions in the clinical pain management setting are inadequate. Clinical data collected for patient management often are not based on validated instruments, and this impedes the ability to conduct longitudinal research. To address these needs, modified patient intake and return visit forms were established and the Assessment of Pain Outcomes Longitudinal Electronic Data Capture system was developed. Data collection has been underway since November 22, 2010. As of December 7, 2011, 951 New Patient and 688 Return Visit forms had been entered. The forms have been well received, with less than 6.5% failing to complete at least 90% of the data requested. Accuracy of data entry is excellent, with an error rate of 1 in 11,250 potential data points. Data output converts easily to standard statistical programs. The creation of a pain outcomes database using validated measures and clinically relevant data is feasible.

  10. CT-guided pericardiocenteses: Clinical profile, practice patterns and clinical outcome

    Energy Technology Data Exchange (ETDEWEB)

    Eichler, Katrin, E-mail: k.eichler@em.uni-frankfurt.d [Department of Diagnostic and Interventional Radiology, University of Frankfurt, Frankfurt (Germany); Zangos, Stephan; Thalhammer, Axel; Jacobi, Volkmar [Department of Diagnostic and Interventional Radiology, University of Frankfurt, Frankfurt (Germany); Walcher, Felix; Marzi, Ingo [Department of Trauma, Hand and Reconstructive Surgery, University of Frankfurt, Frankfurt (Germany); Moritz, Anton [Department of Thoracic and Cardiovascular Surgery, University of Frankfurt, Frankfurt (Germany); Vogl, Thomas J.; Mack, Martin G. [Department of Diagnostic and Interventional Radiology, University of Frankfurt, Frankfurt (Germany)

    2010-07-15

    Objective: To assess the effectiveness and clinical outcome and technique of CT-guided pericardiocenteses in the treatment of pericardial effusions in adults and children. Methods: 20 drainages were performed in Seldinger-technique under CT-guidance on 20 patients suffering from pericardial effusions and haematomas. In 85%, the etiology of effusion was postoperative. The mean age of the patients was 59 years (minimum 9 years, maximum 86 years).There were 12 male and eight female patients. The inclusion criterion was an echocardiographically relevant proved pericardial effusion. Results: All catheters could be placed successfully (20/20) in the pericardial effusion and allowed for draining of the effusion in all cases under CT-guidance. The overall 30-day mortality rate was 0%. CT-guided pericardiocentesis was successful for withdrawing pericardial fluid and/or relieving tamponade in 100% of all procedures. No major complication was occurred. A total of one minor complication (5%) occurred that required no specific interventions, except for monitoring and appropriate follow-up. We observed one pneumothorax as a minor complication. Conclusions: Pericardial effusions of various causes can be safely, effectively, and quickly managed with CT-guided pericardiocenteses in adults and children. The ventrolateral entry side for the puncture should be preferred to reach the whole effusion and avoid complications, like a pneumothorax.

  11. The Promise of Patient-Reported Outcomes Measurement Information System-Turning Theory into Reality: A Uniform Approach to Patient-Reported Outcomes Across Rheumatic Diseases.

    Science.gov (United States)

    Witter, James P

    2016-05-01

    PROMIS, the Patient-Reported Outcomes Measurement Information System, is opening new possibilities to explore and learn how patient (or proxy) self-report of core symptoms and health-related quality of life can meaningfully advance clinical research and patient care. PROMIS leverages Item Response Theory to agnostically assess, across diseases and conditions or clinical settings, numerous universally applicable core "domains" of health (symptoms and functioning) from the patient perspective. Importantly, PROMIS is enabling the testing and adoption of computerized adaptive testing, which holds great potential to minimize patient burden while maximizing accuracy.

  12. Sputum biomarkers and the prediction of clinical outcomes in patients with cystic fibrosis.

    Directory of Open Access Journals (Sweden)

    Theodore G Liou

    Full Text Available Lung function, acute pulmonary exacerbations (APE, and weight are the best clinical predictors of survival in cystic fibrosis (CF; however, underlying mechanisms are incompletely understood. Biomarkers of current disease state predictive of future outcomes might identify mechanisms and provide treatment targets, trial endpoints and objective clinical monitoring tools. Such CF-specific biomarkers have previously been elusive. Using observational and validation cohorts comprising 97 non-transplanted consecutively-recruited adult CF patients at the Intermountain Adult CF Center, University of Utah, we identified biomarkers informative of current disease and predictive of future clinical outcomes. Patients represented the majority of sputum producers. They were recruited March 2004-April 2007 and followed through May 2011. Sputum biomarker concentrations were measured and clinical outcomes meticulously recorded for a median 5.9 (interquartile range 5.0 to 6.6 years to study associations between biomarkers and future APE and time-to-lung transplantation or death. After multivariate modeling, only high mobility group box-1 protein (HMGB-1, mean=5.84 [log ng/ml], standard deviation [SD] =1.75 predicted time-to-first APE (hazard ratio [HR] per log-unit HMGB-1=1.56, p-value=0.005, number of future APE within 5 years (0.338 APE per log-unit HMGB-1, p<0.001 by quasi-Poisson regression and time-to-lung transplantation or death (HR=1.59, p=0.02. At APE onset, sputum granulocyte macrophage colony stimulating factor (GM-CSF, mean 4.8 [log pg/ml], SD=1.26 was significantly associated with APE-associated declines in lung function (-10.8 FEV(1% points per log-unit GM-CSF, p<0.001 by linear regression. Evaluation of validation cohorts produced similar results that passed tests of mutual consistency. In CF sputum, high HMGB-1 predicts incidence and recurrence of APE and survival, plausibly because it mediates long-term airway inflammation. High APE-associated GM

  13. Planning and predictability of clinical outcomes in esthetic rehabilitation.

    Science.gov (United States)

    Kurbad, A

    2015-01-01

    In esthetic rehabilitation, it is a challenge to meet the needs of patients with growing expectations. Creating predictable results is the key to success. This can be accomplished by performing a comprehensive esthetic diagnosis, elaborating treatment proposals that satisfy today's esthetic standards, and using modern computer-assisted methods. The diagnostic wax-up and mock-up are effective tools that allow patients to visualize treatment proposals without invasive procedures. Once the patient has approved the proposals, they provide the basis for the fabrication of the final restoration. The use of modern ceramic materials makes it possible to achieve a good esthetic outcome, even in restorations with extremely thin layer thicknesses. Esthetic cementation is the final step of restorative treatment.

  14. Attenuation of rate of change in carotid intima-media thickness by lipid-modifying drugs: impact on clinical outcomes.

    Science.gov (United States)

    Peters, Sanne A E; den Ruijter, Hester M; Bots, Michiel L

    2011-08-01

    Measurements of carotid intima-media thickness (CIMT) are widely used in clinical research as a measure of atherosclerosis. Many randomized controlled trials (RCTs) have been performed using the rate of change in CIMT as the primary endpoint to study the efficacy of lipid-modifying therapies. The main advantage of using CIMT over the use of cardiovascular events as a primary endpoint is the greater efficiency and feasibility. The underlying assumption for the use of CIMT in trials is that the rate of change in CIMT achieved by a therapy reflects a change in the risk for cardiovascular events. We therefore set out to assess the evidence showing whether the rate of change in CIMT induced by lipid-lowering therapies has an impact on clinical outcomes, by reviewing the available evidence based on a search of the PubMed database. Solid evidence from observational studies shows that increased CIMT relates to an increase in cardiovascular risk. RCTs consistently demonstrate that the annual rate of change in CIMT is favourably affected by lipid-modifying therapies. One study investigating the relationship between the rate of change in CIMT and clinical events has been published and showed a positive relationship between these two outcomes. A published meta-analysis based on pooled CIMT data from statin trials has shown a positive relationship between attenuated rate of change in CIMT after statin therapy and clinical outcomes. However, methodological issues question the validity of the meta-analytical approach. The consistent agreement between results from CIMT trials and event trials on the effects of lipid-modifying therapies, however, clearly supports the presence of a relationship between changes in CIMT and clinical endpoints. Therefore, although direct evidence is scarce, the data overall on whether the attenuation of rate of change in CIMT by lipid-lowering therapies impact on clinical outcomes are supportive.

  15. A clinical study of fetomaternal outcome in pregnancy with polyhydramnios

    Directory of Open Access Journals (Sweden)

    Aditi Anil Rajgire

    2016-12-01

    Full Text Available Background: Amniotic fluid not only provides protection to the fetus from traumatic forces, cord compression, and microbial pathogens, but also plays an integral role in the normal development of the fetal musculoskeletal, pulmonary, and gastrointestinal systems. Polyhydramnios, defined as an excessive amount of amniotic fluid, complicates approximately 0.4-3.3% of all pregnancies. Fetal conditions that are associated with polyhydramnios include major congenital anomalies and both the immunologic and non-immunologic forms of hydrops foetalis. Maternal medical conditions are also known to be associated with polyhydramnios and subsequently alter perinatal outcome. So by diagnosing these cases as early as possible, these maternal complications can be prevented and advise proper prenatal counseling in relevant cases. Methods: This study was conducted in obstetrics and gynaecology department at a tertiary care hospital, over the period of from September 2015 to September 2016. Prospective observational study. Results: Polyhydramnios is commoner in primigravida. Causative factor are mainly idiopathic after which the most important is fetal defects. Diabetes is also associated finding with polyhydramnios in 8.3% cases. The occurrence of fetal congenital abnormality was directly proportional to the gestational age of pregnancy. Incidence of congenital abnormality was found to be 1.25 %. Congenital heart disease and cleft lip and cleft palate (3% were the commonest congenital abnormality associated with polyhydramnios followed by anencephaly and spina bifida (3.3%. Conclusions: In our study Idiopathic polyhydramnios was found to be the most common cause of polyhydramnios. A careful study must be done for detection of etiological factors in all cases of polyhydramnios, careful screening, prenatal and antenatal counseling will help to improve the foetal outcome as well as to prevent the maternal complication.

  16. Vision and vision-related outcome measures in multiple sclerosis

    DEFF Research Database (Denmark)

    Balcer, Laura J; Miller, David H; Reingold, Stephen C;

    2015-01-01

    of investigators involved in the development and study of visual outcomes in multiple sclerosis, which had, as its overriding goals, to review the state of the field and identify areas for future research. We review data and principles to help us understand the importance of vision as a model for outcomes...

  17. Gender differences in the management and clinical outcome of stable angina.

    NARCIS (Netherlands)

    Daly, C.A.; Clemens, F.; Lopez Sendon, J.L.; Tavazzi, L.; Boersma, E.; Danchin, N.; Delahaye, F.; Gitt, A.; Julian, D.; Mulcahy, D.; Ruzyllo, W.; Thygesen, K.; Verheugt, F.W.A.; Fox, K.M.

    2006-01-01

    BACKGROUND: We sought to examine the impact of gender on the investigation and subsequent management of stable angina and to assess gender differences in clinical outcome at 1 year. METHODS AND RESULTS: The Euro Heart Survey of Stable Angina enrolled patients with a clinical diagnosis of stable angi

  18. Persistent systemic inflammation is associated with poor clinical outcomes in COPD

    DEFF Research Database (Denmark)

    Agustí, Alvar; Edwards, Lisa D; Rennard, Stephen I

    2012-01-01

    Because chronic obstructive pulmonary disease (COPD) is a heterogeneous condition, the identification of specific clinical phenotypes is key to developing more effective therapies. To explore if the persistence of systemic inflammation is associated with poor clinical outcomes in COPD we assessed...

  19. Vincristine pharmacokinetics is related to clinical outcome in children with standard risk acute lymphoblastic leukemia

    NARCIS (Netherlands)

    Loennerholm, Gudmar; Frost, Britt-Marie; Abrahamsson, Jonas; Behrendtz, Mikael; Castor, Anders; Forestier, Erik; Heyman, Mats; Uges, Donald R. A.; de Graaf, Siebold S. N.

    2008-01-01

    Vincristine is a key drug in the treatment of childhood and adult acute lymphoblastic leukemia (ALL), and many other childhood malignancies. Despite decades of wide clinical use, no data on the correlation between vincristine pharmacokinetics and long-term clinical outcome have been published. We he

  20. The relationship between clinical outcomes and medication adherence in difficult-to-control asthma.

    Science.gov (United States)

    Murphy, Anna C; Proeschal, Amandine; Brightling, Christopher E; Wardlaw, Andrew J; Pavord, Ian; Bradding, Peter; Green, Ruth H

    2012-08-01

    Medication non-adherence and the clinical implications in difficult-to-control asthma were audited. Prescription issue data from 115 patients identified sub-optimal adherence (asthma (p=0.008). The majority of patients with difficult-to-control asthma are non-adherent with their asthma medication. Non-adherence is correlated with poor clinical outcomes.

  1. Pregnancy outcomes in Ghana : Relavance of clinical decision making support tools for frontline providers of care

    NARCIS (Netherlands)

    Amoakoh-Coleman, M.

    2016-01-01

    Ghana’s slow progress towards attaining millennium development goal 5 has been associated with gaps in quality of care, particularly quality of clinical decision making for clients. This thesis reviews the relevance and effect of clinical decision making support tools on pregnancy outcomes. Relevanc

  2. Patient perspectives on antipsychotic treatments and their association with clinical outcomes

    Directory of Open Access Journals (Sweden)

    Hong Liu-Seifert

    2010-09-01

    Full Text Available Hong Liu-Seifert1, Olawale O Osuntokun1, Jenna L Godfrey2, Peter D Feldman11Lilly Research Laboratories, Indianapolis, IN, USA; 2Durham Veterans Affairs Medical Center, Durham, NC, USAAbstract: This analysis examined patient-reported attitudes toward antipsychotic medication and the relationship of these attitudes with clinical outcomes and pharmacotherapy adherence. The analysis included three randomized, double-blind studies in patients with schizophrenia, schizoaffective disorder, or schizophreniform disorder diagnosed according to the Diagnostic and Statistical Manual of Mental Disorders 4th Edition and randomly assigned to treatment with olanzapine 5–20 mg/day or another antipsychotic (haloperidol 2–20 mg/day, risperidone 2–10 mg/day, or ziprasidone 80–160 mg/day. Patient-reported improvements were significantly greater for olanzapine (n = 488 versus other treatments (haloperidol n = 145, risperidone n = 158, or ziprasidone n = 271 on multiple Drug Attitude Inventory items. A positive attitude toward medication reported by patients was significantly associated with greater clinical improvement on the Positive and Negative Syndrome Scale and lower discontinuation rates. These results suggest that patients’ perceptions of treatment benefits are associated with objective clinical measures, including reduction of symptom severity and lower discontinuation rates. Furthermore, olanzapine may be associated with more positive treatment attitudes. These findings may contribute to a better understanding of reasons for treatment adherence from patients’ own perspectives.Keywords: antipsychotic agents, medication adherence, patient satisfaction, schizophrenia, treatment efficacy

  3. The use of collaboration science to define consensus outcome measures: a telemental health case study.

    Science.gov (United States)

    Mishkind, Matthew C; Doarn, Charles R; Bernard, Jordana; Shore, Jay H

    2013-06-01

    The purpose of this document is to provide an overview of a collaboration science process used to develop recommendations for the field of telemental health (TMH) in the selection of outcome measures that best reflect programmatic impacts. A common use of group development techniques in medicine is the development of clinical guidelines, which typically occurs using one of two methods: the nominal group or the Delphi method. Both processes have been faulted for limited transparency, reliability, and sustainability. Recommendations to improve the traditional process include making goals explicit, making disagreements transparent, and publicly displaying levels of agreement. A group of 26 TMH experts convened during the American Telemedicine Association's 2012 Fall Forum in New Orleans, LA to participate in a 1-day, interactive, consensus-building workshop to initiate the development of a shared lexicon of outcomes. The workshop method was designed to improve on traditional methods of guideline development by focusing on clarity of expectations, transparency, and timeliness of group development work. Results suggest that, compared with other traditional methods, the current process involved more people, occurred more rapidly, was more transparent, and resulted in a comparable deliverable. Recommendations for further process development, both within and external to TMH, as well as an initial overview of defined outcome measures are discussed.

  4. Prediction of responders for outcome measures of Locomotor Experience Applied Post Stroke trial

    Directory of Open Access Journals (Sweden)

    Bruce H. K. Dobkin, MD

    2014-03-01

    Full Text Available The Locomotor Experience Applied Post Stroke rehabilitation trial found equivalent walking outcomes for body weight-supported treadmill plus overground walking practice versus home-based exercise that did not emphasize walking. From this large database, we examined several clinically important questions that provide insights into recovery of walking that may affect future trial designs. Using logistic regression analyses, we examined predictors of response based on a variety of walking speed-related outcomes and measures that captured disability, physical impairment, and quality of life. The most robust predictor was being closer at baseline to the primary outcome measure, which was the functional walking speed thresholds of 0.4 m/s (household walking and 0.8 m/s (community walking. Regardless of baseline walking speed, a younger age and higher Berg Balance Scale score were relative predictors of responding, whether operationally defined by transitioning beyond each speed boundary or by a continuous change or a greater than median increase in walking speed. Of note, the cutoff values of 0.4 and 0.8 m/s had no particular significance compared with other walking speed changes despite their general use as descriptors of functional levels of walking. No evidence was found for any difference in predictors based on treatment group.

  5. The OnyCOE-t™ questionnaire: responsiveness and clinical meaningfulness of a patient-reported outcomes questionnaire for toenail onychomycosis

    OpenAIRE

    Kianifard Farid; Raut Monika; Mathias Susan D; Potter Lori P; Tavakkol Amir

    2006-01-01

    Abstract Background This research was conducted to confirm the validity and reliability and to assess the responsiveness and clinical meaningfulness of the OnyCOE-t™, a questionnaire specifically designed to measure patient-reported outcomes (PRO) associated with toenail onychomycosis. Methods 504 patients with toenail onychomycosis randomized to receive 12 weeks of terbinafine 250 mg/day with or without target toenail debridement in the IRON-CLAD® trial completed the OnyCOE-t™ at baseline, w...

  6. Incidence and clinical outcome of renal amyloidosis: A retrospective study

    Directory of Open Access Journals (Sweden)

    Emad Abdallah

    2013-01-01

    Full Text Available The kidneys are affected in almost all patients with amyloid A in secondary amyloidosis (AA amyloidosis but less frequently in immunoglobulin light chains in primary systemic amyloidosis (AL amyloidosis. In this study, we present the incidence, etiology, clinical manifestations, biochemical features and clinical course of renal amyloidosis. We conducted a retrospective study on a group of 40 cases with renal biopsy-proven amyloidosis. They constituted 2.5% of the total cases of renal biopsies performed in the Theodor Bilharz Research Institute, Cairo, Egypt, during the period from February 2003 to May 2009. The mean age (30 males, ten females was 36.51 ± 10.32 years. Thirty-two of the cases had secondary AA amyloidosis and eight cases had primary AL amyloidosis. The causes of secondary amyloidosis were as follows: 12 (30% familial Mediterranean fever (FMF, eight (20% pulmonary tuberculosis, four (10% chronic osteomyelitis, four (10% bronchiectasis, three (7% rheumatoid arthritis and one (2% rheumatic heart disease. The eight cases of primary AL amyloidosis comprised of five cases that were associated with myloma (13% and three (8% cases that were idiopathic. Among the 23 patients with AA amyloidosis, after six months of treatment with colchicine, the proteinuria improved, serum albumin level increased and edema disappeared in 13 patients. In four cases of AA amyloidosis who were clinically and biochemically normal after cholchicine therapy, a second renal biopsy disclosed decreased amyloid deposition compared with the first biopsy. In the three renal transplanted patients who had amyloidosis secondary to FMF and were treated with colchicines, AA amyloidosis did not recur in the transplanted kidney. It might be possible that in AL amyloidosis, treatment with methotrexate, melphalan and prednisolone may improve survival. The incidence of renal amyloidosis is increasing and colchicine can be used in secondary amyloidosis as it may have an effect

  7. Caspofungin: Pharmacodynamics, pharmacokinetics, clinical uses and treatment outcomes.

    Science.gov (United States)

    Song, Jessica C; Stevens, David A

    2016-09-01

    Over the past decade, echinocandins have emerged as first-line antifungal agents for many Candida infections. The echinocandins have a unique mechanism of action, inhibiting the synthesis of β-1,3-d-glucan polymers, key components of the cell wall in pathogenic fungi. Caspofungin was the first echinocandin antifungal agent to become licensed for use. The objectives of this review are to summarize the existing published data on caspofungin, under the subject headings of chemistry and mechanism of action, spectrum of activity, pharmacodynamics, pharmacokinetics, clinical studies, safety, drug interactions, dosing, and an overview of the drug's current place in therapy.

  8. Clinical outcome after percutaneous flexor tenotomy in forefoot surgery.

    Science.gov (United States)

    Debarge, Romain; Philippot, Rémy; Viola, Jérémy; Besse, Jean Luc

    2009-10-01

    The aim of this study was to evaluate the outcome of the percutaneous flexor tenotomy. We compared the results of two groups. The first group included 23 patients who underwent forefoot surgery without percutaneous flexor tenotomy, and the second group included 50 patients who underwent the same procedure combined with percutaneous flexor tenotomy for claw toe deformities, secondary to shortening metatarsal Scarf osteotomy. The average follow-up was 11.6 months. Three algoneurodystrophies were noted. No delayed wound healing was observed. Functional dissatisfaction rate (18% vs.17.4%) and toe pulp contact defect (12% vs. 8.7%) were not significantly different in the two groups. Toe grasping defect rate (10% vs. 4.3%) was superior in the tenotomy group. Five recurring claw toe deformities of the second toe were noted in the tenotomy group. Percutaneous flexor tenotomy is a simple, rapid, and efficient method to correct reducible secondary claw toe deformities. However, despite a significant postoperative loss of toe grasping function, no patient reported major dissatisfaction.

  9. Unravelling the Mystery Between Structure and Sustained Clinical Outcomes

    Directory of Open Access Journals (Sweden)

    Edward Keystone

    2016-07-01

    Full Text Available Targeted biologics have revolutionised the treatment and outlook of patients with inflammatory joint diseases. The combination of high-cost long-term therapy straining healthcare systems with impending expiry of key biologics patents has led to heightened interest in the development of biosimilars. The expanding landscape of biosimilars has triggered, in healthcare providers, the need to explore the option to non-medically switch stable patients from costly reference products to less expensive alternatives. Currently, there are many unknowns surrounding the effects of non-medical switching on patient outcomes and cost-effectiveness. Prof Edward Keystone opened the symposium by discussing the constantly evolving landscape of biologics, highlighting that their high cost is becoming an increasing challenge and has created the issue of non-medical switching. Dr Leigh Revers provided a background to the structural and functional relationships of biologic therapies, stressing the need for careful control of the manufacturing processes of these large and complex molecules. Prof Keystone presented the long-term data currently available for anti-tumour necrosis factor (anti-TNF agents and examined how sustainability of response can be influenced by multiple factors. Prof Thomas Dörner concluded the symposium by stressing the importance of the prescribing doctor being in control of which biologics their patients receive to ensure effective pharmacovigilance. The challenge of non-medical switching was discussed along with the potential trial designs that could help to determine if biologics and biosimilars could be interchangeable.

  10. CLINICAL PROFILE AND TREATMENT OUTCOMES IN PATIENTS WITH ANKYLOSING SPONDYLITIS

    Directory of Open Access Journals (Sweden)

    Ramesh Naidu

    2015-09-01

    Full Text Available Ankylosing spondylitis belongs to a group of diseases known as Spondyloarthritides characterized by inflammatory low backache. It is a chronic inflammatory disease of unknown etiology, mostly associated with HLA B27 positivity affecting skeletal (both axial and extra - axial and extra skeletal system. In general population Ankylosing spondylitis is likely to develop in about 1% to 2% of HLA - B27+ who have a disease - associated B27 subtype and is much more common among HLA - B27+ first degree relatives of HLA - B27+ AS Patients. Positive family history is a strong risk factor for the development of the disease. Ankylosing Spondylitis is a disease which mostly affects young males and working population. It is a chronic illness with exacerbations and remissions and leads to debility and significant morbidity and hence affects the quality of life significantly. This study has been carried out in Medicine department of Ra ngaraya medical college GGH Kakinada, Sraddha Hospital, Visakhapatnam, Andhra medical college, KGH, Visakhapatnam, GEMS College and Hospital, Srikakulam with an aim to study the articular and extra articular manifestations of Ankylosing Spondylitis, factor s affecting exacerbations and remissions. Correlation between disease activity and acute phase reactants, familial association, and to study the short term treatment outcomes.

  11. Clinical and functional outcomes of tibial intercalary allograft reconstructions

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    Lucas López Millán

    2012-12-01

    Full Text Available Background The purpose of this study was to evaluate the survival, the complications and the functional outcome of intercalary tibial allografts reconstructions following tumor resections. Methods Intercalary tibia segmental allografts were implanted in 26 consecutive patients after segmental resections. Average follow-up was 6 years. Allograft survival was determined with the Kaplan-Meier method. Function was evaluated with the Musculoskeletal Tumor Society scoring system (MSTS. Results The rate of survival was 84% (CI 95%: 90%- 70% at 5 years and 79% at 10 years (CI 95%: 95%-63%. Allografts were removed in 5 patients (3 due to infections and 2 due to local recurrences. Two patients showed diaphyseal nonunion and 3 had an incomplete fracture, but it was not necessary to remove the allografts. Average MSTS functional score was 29 points (range 27 to 30. Conclusions Despite the incidence of complications, this analysis showed an acceptable survival with excellent functional scores. The use of intercalary allograft clearly has a place in the reconstruction of a segmental defect created by the resection of a tumor in the diaphyseal and/or metaphyseal portion of the tibia.

  12. Clinical Infectious Outcomes Associated with Biofilm-related Infections: a Retrospective Chart Review

    Science.gov (United States)

    2015-06-07

    analysis of potential clinical risk factors and infectious outcomes of a large data set is an important addition to the understand- ing of this...in adults. Clin Infect Dis. 2005;40(5):643–54. 11. Mermel LA, Allon M, Bouza E, Craven DE, Flynn P, O’Grady NP, et al. Clinical practice guidelines ...associated urinary tract infection in adults: 2009 International Clinical Practice Guidelines from the Infectious Diseases Society of America. Clin

  13. Hypertensive thalamic hemorrhage. Clinical symptoms and outcomes in 40 cases

    Energy Technology Data Exchange (ETDEWEB)

    Munaka, Masahiro; Nishikawa, Michio; Hirai, Osamu; Kaneko, Takaaki; Watanabe, Syu; Fukuma, Jun; Handa, Hajime

    1988-12-01

    In the past six years, we have had experience with 40 patients with hypertensive thalamic hemorrhages, as verified by CT scan at our hospital within 24 hours. These patients were classified into the following three groups according to the location of the bleeding point and the size of the hematoma: (1) anteromedial (4 cases), (2) posterolateral (16 cases), and (3) massive (20 cases). The (1) and (2) hematomas were small (less than 3 cm in diameter), while those in (3) were large (more than 3 cm in diameter). Twenty cases (50% of all the thalamic hematomas) were small hematomas. The characteristic clinical symptoms of the anteromedial type were a mild disturbance of consciousness and thalamic dementia, while those of the posterolateral type were motor and sensory disturbance, and thalamic aphasia, respectively. Twenty cases (50%) were large hematomas. The clinical symptoms of these cases were mainly consciousness disturbance; 7 of them expired. Based on this experience, it may be considered that the patients whose hematoma size was larger than 3 cm had a poor prognosis and that the patients with the posterolateral type had a poor functional diagnosis.

  14. Adjunctive naturopathic care for type 2 diabetes: patient-reported and clinical outcomes after one year

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    Bradley Ryan

    2012-04-01

    Full Text Available Abstract Background Several small, uncontrolled studies have found improvements in self-care behaviors and reductions in clinical risk in persons with type 2 diabetes who received care from licensed naturopathic physicians. To extend these findings and determine the feasibility and promise of a randomized clinical trial, we conducted a prospective study to measure the effects of adjunctive naturopathic care (ANC in primary care patients with inadequately controlled type 2 diabetes. Methods Forty patients with type 2 diabetes were invited from a large integrated health care system to receive up to eight ANC visits for up to one year. Participants were required to have hemoglobin A1c (HbA1c values between 7.5-9.5 % and at least one additional cardiovascular risk factor (i.e., hypertension, hyperlipidemia or overweight. Standardized instruments were administered by telephone to collect outcome data on self-care, self-efficacy, diabetes problem areas, perceived stress, motivation, and mood. Changes from baseline scores were calculated at 6- and 12-months after entry into the study. Six and 12-month changes in clinical risk factors (i.e., HbA1c, lipid and blood pressure were calculated for the ANC cohort, and compared to changes in a cohort of 329 eligible, non-participating patients constructed using electronic medical records data. Between-cohort comparisons were adjusted for age, gender, baseline HbA1c, and diabetes medications. Six months was pre-specified as the primary endpoint for outcome assessment. Results Participants made 3.9 ANC visits on average during the year, 78 % of which occurred within six months of entry into the study. At 6-months, significant improvements were found in most patient-reported measures, including glucose testing (P = 0.001, diet (P = 0.001, physical activity (P = 0.02, mood (P = 0.001, self-efficacy (P = 0.0001 and motivation to change lifestyle (P = 0.003. Improvements in glucose testing, mood, self-efficacy and

  15. Validation of the Italian version of the SBMA Functional Rating Scale as outcome measure.

    Science.gov (United States)

    Querin, Giorgia; DaRe, Elisa; Martinelli, Ilaria; Bello, Luca; Bertolin, Cinzia; Pareyson, Davide; Mariotti, Caterina; Pegoraro, Elena; Sorarù, Gianni

    2016-11-01

    The Spinal and Bulbar Muscular Atrophy Functional Rating Scale (SBMAFRS) is an established rating instrument used to assess the functional status of patients with Spinal and Bulbar Muscular Atrophy (SBMA). Our aim was to validate an Italian version of the scale. We administered the SBMAFRS to sixty SBMA patients during routine follow-up of clinical evaluations. To estimate the test stability, the scale was re-administered to a subset of 39 randomly selected patients after 8 weeks. The patients underwent clinical evaluation including 6-min walk. Psychometric analysis included reliability assessment and factorial analysis. To evaluate convergent validity, correlations between SBMAFRS items and muscular force assessed by manual testing, ALSFRS total score and subscales scores, and forced vital capacity, were performed. Internal consistency as measured by Cronbach's alpha (total scale 0.85) was high. Test-retest reliability assessed by Spearman's rho was also high. Principal component analysis with varimax rotation yielded a four-factor solution accounting for approximately 79 % of the variance. The scale total score and subscales score were strongly correlated with respective items and subscores of the ALSFRS, with respiratory function and with the 6-min walk test. In conclusion, we performed an Italian validation of the only existing disease-specific Functional Rating Scale for SBMA patients. This scale will be a useful tool not only in the clinical practice but also as an outcome measure in upcoming clinical trials.

  16. Rhino-Orbito-Cerebral Mucormycosis. A Retrospective Analysis of Clinical Features and Treatment Outcomes

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    Nithyanandam Suneetha

    2003-01-01

    Full Text Available Objective: The conventional management of rhino-orbito-cerebral (ROC mucormycosis includes control of metabolic abnormality, administration of amphotericin B and surgery that spans simple sinus clearance, radical debridement and orbital exenteration. Recent literature includes anecdotal descriptions of successful treatment with conservative management of involved orbits. We evaluated the clinical features and outcome of treatment for the different stages of ROC mucormycosis. Method: In this retrospective case series, 34 case records of patients with a histopathological diagnosis of ROC mucormycosis treated between 1992 and 2000 were reviewed. Three clinical stages and three treatment groups were identified. Patients with limited sino-nasal disease (Clinical stage I underwent sino-nasal debridement (Treatment group A. Patients with limited rhino-orbital disease (Clinical stage II underwent either sino-nasal debridement alone (Treatment group A or orbital exenteration in addition to sino-nasal debridement (Treatment group B. Patients with rhino-orbito-cerebral disease (Clinical stage III did not undergo any surgical procedure (Treatment group C. Thirty-three patients received intravenous amphotericin B. Outcome for each group was measured as "Treatment success" (disease free, stable patient with metabolic abnormality under control and "Treatment failure" (progression of disease with worsening general condition or mortality due to the disease. Results: Uncontrolled diabetes in 30 (88.2% of 34 patients was the commonest underlying disease and 16 (53.3% of 30 diabetics had ketoacidosis. Chronic renal failure (n = 4, hepatic disease (n = 3 and idiopathic thrombocytopenia (n = 1 were the other underlying diseases. Eleven patients had stage I disease, 16 patients had stage II disease and seven patients had stage III disease. All 11 patients with stage I disease received treatment A; of 16 patients with stage II disease, 7 received treatment A and the

  17. Clinical and Radiological Outcome of Titanium Implants in Clinical Practice: A 5 Year, Prospective, Multicenter Case Series

    Directory of Open Access Journals (Sweden)

    Claude Jaquiéry

    2014-11-01

    Full Text Available The objective of this prospective clinical case series was to confirm the 5-year clinical and radiographic performance of titanium implants occlusally loaded after 12 weeks. Periapical X-rays for quantitative bone level assessment were taken immediately post-surgery, after loading, 6 and 12 months, and 5 years after loading. Pocket depth (PD and clinical attachment level (CAL were measured. One-hundred and fourteen implants were inserted in 71 consecutive patients; 111 (97% implants/69 (97% patients were followed for 5 years. One implant was lost before loading (acute infection of unknown origin. Another patient developed peri-implantitis in the healing phase, and underwent successful surgical revision. Mesial median bone level at 6 and 12 months, and 5 years was 1.2 (SD ± 0.7, 1.3 (SD ± 0.7 and 1.1 (SD ± 0.6 mm; distal values were: 1.1 (SD ± 0.7, 1.4 (SD ± 0.7 and 1.2 (SD ± 0.6 mm; below implant shoulder. Stable CAL (1.2–1.6 mm and PD (2.0–3.0 mm were found. After 5 years no implant was lost. Three crowns and one abutment screw were defective and replaced. Implant survival (1 failure/114 as well as minimal peri-implant bone loss confirmed the favorable outcome of the used implant line. Five years post-loading, crestal bone stabilized slightly below the machined/rough border.

  18. Clinical outcome of deep brain stimulation for Parkinson's disease.

    Science.gov (United States)

    Deuschl, Günther; Paschen, Steffen; Witt, Karsten

    2013-01-01

    Deep brain stimulation is one of the most effective treatments of Parkinson's disease (PD). This report summarizes the state of the art as at January 2013. Stimulation of the subthalamic nucleus is the most commonly used approach. It improves the core motor symptoms better than medication in patients with advanced disease. It also improves the majority of nonmotor symptoms, such as mood, impulse control disorders, sleep, and some autonomic dysfunctions. Quality of life (QoL) is improved significantly more than with medication. Long-term data show that the treatment is effective for up to 10 years, but the late appearance of l-dopa-resistant symptoms is seemingly not influenced. Internal globus pallidus (GPi) stimulation is less well studied but seems to have similar short-term efficacy. Importantly l-dopa use cannot be reduced with GPi DBS, which is a major disadvantage for patients suffering from medication side-effects, although gait may be influenced more positively. Although short-term QoL improvement seems to be similar to that for subthalamic nucleus (STN) DBS - gait and speech may be better improved - long-term data are rare for GPi DBS. Thalamic stimulation in the ventral intermediate nucleus (VIM) is applied only in tremor-dominant elderly patients. The treatment improves the dopa-sensitive symptoms and effectively reduces fluctuations leading to an overall QoL improvement. Although most of the controlled studies have been on advanced PD, the recently published EARLYSTIM study suggests that even patients with a very short duration of their fluctuations and dyskinesia are doing significantly better with neurostimulation in terms of QoL and all major motor outcome parameters.

  19. Clinical outcome and follow-up of prenatal hydronephrosis

    Directory of Open Access Journals (Sweden)

    Afshin Safaei Asl

    2012-01-01

    Full Text Available Hydronephrosis is probably the most common congenital abnormality detected prenatally by ultrasonography This study was performed to determine the cause and outcome of prenatal hydronephrosis in our hospital. A total of 45 infants, with 57 prenatally hydronephrotic renal units, were enrolled into this study. For the purpose of this study, the degree of hydronephrosis was defined as mild, moderate or severe. Postnatal ultrasonography was performed as soon as possible in those with bilateral hyronephrosis and 3-7 days after birth in those with unilateral hydronephrosis. Voiding cystourethrogram was performed in 6-8 weeks time. In the absence of vesicoureteral reflux (VUR, Diethylenetriamene penta acetate scan was performed to exclude obstructive uropathy. There were 29 males and 16 females (male:female ratio 1.8:1, and unilateral and bilateral hydronephrosis were seen in 33 (73% and 12 (27% of the cases, res-pectively. Hydronephrosis was caused by ureteropelvic junction obstruction (UPJO in 20 (44.5%, VUR in 10 (22.2%, ureterovesical junction obstruction in four (8.9 %, posteriorurethral valves in four (8.9 %, UPJO with VUR in two (4.4% and non-VUR non-obstructive in one (2.2%. During follow-up, 16 patients (35.5% required operative intervention while seven (15.5% improved spontaneously. Fetal hydronephrosis needs close follow-up during both ante-natal and postnatal periods. In this study, the most common cause for hydronephrosis were UPJO and VUR. Also seen in this study is the noteworthy point that mild fetal hydronephrosis is relatively benign and does not require surgical intervention in most cases and surgery should be performed only if there is renal function compromise. Prenatal consultation with a pediatric nephrologist and urologist is useful in decreasing parental anxiety and facilitating postnatal management.

  20. Hepatology may have problems with putative surrogate outcome measures

    DEFF Research Database (Denmark)

    Gluud, Christian; Brok, Jesper; Gong, Yan;

    2007-01-01

    hepatitis C, serum bilirubin concentration following ursodeoxycholic acid or immunosuppressants for patients with primary biliary cirrhosis, and nutritional outcomes following artificial nutrition for liver patients may not be valid surrogates for morbidity or mortality. The challenge is to develop reliable...

  1. Clinical Outcomes of Primary Palatal Surgery in Children with Nonsyndromic Cleft Palate with and without Lip

    Directory of Open Access Journals (Sweden)

    Seunghee Ha

    2015-01-01

    Full Text Available This study presents clinical outcomes of primary cleft palate surgery, including rate of oronasal fistula development, rate of velopharyngeal insufficiency (VPI requiring secondary surgery, and speech outcomes. We examined the effect of cleft type on the clinical outcomes. Retrospective analysis was performed using clinical records of all patients who received a primary palatoplasty at the Cleft Palate Clinic at Seoul Asan Medical Center, South Korea, between 2007 and 2012. The study included 292 patients with nonsyndromic overt cleft palate (±cleft lip. The results revealed that the rate of oronasal fistula was 7.9% and the incidence of VPI based on the rate of secondary palatal surgery was 19.2%. The results showed that 50.3% of all the patients had received speech therapy and 28.8% and 51.4% demonstrated significant hypernasality and articulatory deficits, respectively. The results of the rate of VPI and speech outcomes were significantly different in terms of cleft type. Except for the rate of oronasal fistula, patients with cleft palate generally exhibited better clinical outcomes compared to those with bilateral or unilateral cleft lip and palate. This study suggests that several factors, including cleft type, should be identified and comprehensively considered to establish an optimal treatment regimen for patients with cleft palate.

  2. Outcome markers for clinical trials in cerebral amyloid angiopathy

    NARCIS (Netherlands)

    S.M. Greenberg (Steven); R.A.S. Salman (Rustam Al-Shahi); G.J. Biessels (Geert Jan); M.A. van Buchem (Mark); C. Cordonnier (Charlotte); J.-M. Lee (Jin-Moo); J. Montaner (Joan); J.A. Schneider (Julie); E.E. Smith (Eric); M.W. Vernooij (Meike); D.J. Werring (David)

    2014-01-01

    textabstractEfforts are underway for early-phase trials of candidate treatments for cerebral amyloid angiopathy, an untreatable cause of haemorrhagic stroke and vascular cognitive impairment. A major barrier to these trials is the absence of consensus on measurement of treatment effectiveness. A ran

  3. Tiotropium in COPD: clinical outcomes and economic evidence

    Directory of Open Access Journals (Sweden)

    Orietta Zaniolo

    2010-03-01

    Full Text Available Tiotropium bromide is a once-daily anticholinergic bronchodilator with duration of action of at least 24 hours. In clinical trials, tiotropium has been compared with placebo, ipratropium or salmeterol, the most frequently used long-acting β2 agonist. When compared with ipratropium or placebo in COPD management, tiotropium resulted associated with FEV1, dyspnoea and health-related quality of life (QoL improvement, along with reduced exacerbation and hospitalisation rates. In comparison to salmeterol, it proved to be superior in terms of lung function improvement and exacerbation risk reduction. Recently, the randomised, double-blind trial UPLIFT showed that 4 years of therapy with tiotropium were associated with improvements in lung function, QoL, and exacerbations, and with an effective reduction of mortality compared with control group in 5,993 patients with moderate to very-severe COPD. These encouraging clinical effects are to be traded against the pharmaceutical cost increase induced by the inclusion of tiotropium in routine care. However, published work indicates that this pharmaceutical cost increase may be totally or partially offset by the reduction in costs needed for exacerbations management and hospitalisations. Depending on the setting analysed, tiotropium is estimated to dominate ipratropium and salmeterol or to be associated with an incremental cost of less than € 2,500 per exacerbation avoided. An Italian model based on UPLIFT data shows that therapy including tiotropium induces an incremental cost of € 6,700 for year of life and of € 7,916 for Quality-adjusted Life Year gained, with respect to routine care alone. These values are much lower than commonly accepted thresholds and than cost/effectiveness results estimated for other long-acting bronchodilators. In conclusion, available evidence suggests that tiotropium may prove an appropriate therapeutic option with a largely affordable cost.

  4. ABO blood groups and malaria related clinical outcom

    Directory of Open Access Journals (Sweden)

    Deepa, Vanamala A. Alwar, Karuna Rameshkumar & Cecil Ross

    2011-03-01

    Full Text Available Objectives: The study was undertaken to correlate the blood groups and clinical presentations in malaria patientsand to understand the differential host susceptibility in malaria.Methods: From October 2007 to September 2008, malaria positive patients’ samples were evaluated in thisstudy. Hemoglobin, total leukocyte count, and platelet count of each patient were done on an automated cellcounter. After determining the blood groups, malarial species and the severity of clinical course were correlated.Results: A total of 100 patients were included in the study, of which 63 cases were positive for Plasmodiumfalciparum and 37 cases were positive for P. vivax infection and 11 patients had mixed infection. The results ofthe blood groups showed 22 – ‘A’ group, 42 – ‘B’ group, 35 – ‘O’ group and 1 was ‘AB’ group. When the clinicalcourses between different groups were compared using the following parameters for severe infection—a parasiticload of >10/1000 RBCs, severe anemia with hemoglobin 101oF and other organ involvement, it wasobserved that ‘O’ group had an advantage over other the groups. The difference in rosetting ability between redblood cells of different ‘ABO’ blood groups with a diminished rosetting potential in blood group ‘O’ red bloodcells was due to the differential host susceptibility.Conclusion: ‘O’ group had an advantage over the other three blood groups. Based on literature and the results ofthis study, the diminished rosetting potential in blood group ‘O’ red blood cells is suggested as the basis for thedifferential host susceptibility.

  5. Effect of crew resource management on diabetes care and patient outcomes in an inner‐city primary care clinic

    Science.gov (United States)

    Taylor, Cathy R; Hepworth, Joseph T; Buerhaus, Peter I; Dittus, Robert; Speroff, Theodore

    2007-01-01

    Background Diabetes care in our inner‐city primary care clinic was suboptimal, despite provider education and performance feedback targeting improved adherence to evidence‐based clinical guidelines. A crew resource management (CRM) intervention (communication and teamwork, process and workflow organisation, and standardised information debriefings) was implemented to improve diabetes care and patient outcomes. Objective To assess the effect of the CRM intervention on adherence to evidence‐based diabetes care standards, work processes, standardised clinical communication and patient outcomes. Methods Time‐series analysis was used to assess the effect on the delivery of standard diabetes services and patient outcomes among medically indigent adults (n = 619). Results The CRM principles were translated into useful process redesign and standardised care approaches. Significant improvements in microalbumin testing and associated patient outcome measures were attributed to the intervention. Conclusions The CRM approach provided tools for management that, in the short term, enabled reorganisation and prevention of service omissions and, in the long term, can produce change in the organisational culture for continuous improvement. PMID:17693668

  6. The effects of vitamin D supplementation on maternal and neonatal outcome: A randomized clinical trial

    Directory of Open Access Journals (Sweden)

    Mahdieh Mojibian

    2015-11-01

    Full Text Available Background: Vitamin D supplementation during pregnancy has been supposed to defend against adverse gestational outcomes. Objective: This randomized clinical trial study was conducted to assess the effects of 50,000 IU of vitamin D every two weeks supplementation on the incidence of gestational diabetes (GDM, gestational hypertension, preeclampsia and preterm labor, vitamin D status at term and neonatal outcomes contrasted with pregnant women that received 400 IU vitamin D daily. Materials and Methods: 500 women with gestational age 12-16 weeks and serum 25 hydroxy vitamin D (25 (OH D less than 30 ng/ml randomly categorized in two groups. Group A received 400 IU vitamin D daily and group B 50,000 IU vitamin D every 2 weeks orally until delivery. Maternal and Neonatal outcomes were assessed in two groups. Results: The incidence of GDM in group B was significantly lower than group A (6.7% versus 13.4% and odds ratio (95% Confidence interval was 0.46 (0.24-0.87 (P=0.01. The mean ± SD level of 25 (OH D at the time of delivery in mothers in group B was significantly higher than A (37.9 ± 19.8 versus 27.2 ± 18.8 ng/ml, respectively (P=0.001. There were no differences in the incidence of preeclampsia, gestational hypertension, preterm labor, and low birth weight between two groups. The mean level of 25 (OH D in cord blood of group B was significantly higher than group A (37.9 ± 18 versus 29.7 ± 19ng/ml, respectively. Anthropometric measures between neonates were not significantly different. Conclusion: Our study showed 50,000 IU vitamin D every 2 weeks decreased the incidence of GDM.

  7. Outcome measures in spinal cord injury: recent assessments and recommendations for future directions

    DEFF Research Database (Denmark)

    Alexander, M S; Anderson, K D; Biering-Sørensen, Fin;

    2009-01-01

    Study design:Review by the spinal cord outcomes partnership endeavor (SCOPE), which is a broad-based international consortium of scientists and clinical researchers representing academic institutions, industry, government agencies, not-for-profit organizations and foundations. Objectives:Assessment...... of current and evolving tools for evaluating human spinal cord injury (SCI) outcomes for both clinical diagnosis and clinical research studies. Methods:a framework for the appraisal of evidence of metric properties was used to examine outcome tools or tests for accuracy, sensitivity, reliability and validity...

  8. Are the outcomes of clinical pathways evidence-based? A critical appraisal of clinical pathway evaluation research

    NARCIS (Netherlands)

    El Baz, N.; Middel, B.; Van Dijk, J.P.; Oosterhof, A.; Boonstra, P.W.; Reijneveld, S.A.

    2007-01-01

    Aim and objective To evaluate the validity of study outcomes of published papers that report the effects of clinical pathways (CP). Method Systematic review based on two search strategies, including searching Medline, CINAHL, Embase, Psychinfo and Picarta from 1995 till 2005 and ISI Web of Knowledge

  9. C2-fractures: part II. A morphometrical analysis of computerized atlantoaxial motion, anatomical alignment and related clinical outcomes.

    Science.gov (United States)

    Koller, Heiko; Acosta, Frank; Forstner, Rosemarie; Zenner, Juliane; Resch, Herbert; Tauber, Mark; Lederer, Stefan; Auffarth, Alexander; Hitzl, Wolfgang

    2009-08-01

    Knowledge on the outcome of C2-fractures is founded on heterogenous samples with cross-sectional outcome assessment focusing on union rates, complications and technical concerns related to surgical treatment. Reproducible clinical and functional outcome assessments are scant. Validated generic and disease specific outcome measures were rarely applied. Therefore, the aim of the current study is to investigate the radiographic, functional and clinical outcome of a patient sample with C2-fractures. Out of a consecutive series of 121 patients with C2 fractures, 44 met strict inclusion criteria and 35 patients with C2-fractures treated either nonsurgically or surgically with motion-preserving techniques were surveyed. Outcome analysis included validated measures (SF-36, NPDI, CSOQ), and a functional CT-scanning protocol for the evaluation of C1-2 rotation and alignment. Mean follow-up was 64 months and mean age of patients was 52 years. Classification of C2-fractures at injury was performed using a detailed morphological description: 24 patients had odontoid fractures type II or III, 18 patients had fracture patterns involving the vertebral body and 11 included a dislocated or a burst lateral mass fracture. Thirty-one percent of patients were treated with a halo, 34% with a Philadelphia collar and 34% had anterior odontoid screw fixation. At follow-up mean atlantoaxial rotation in left and right head position was 20.2 degrees and 20.6 degrees, respectively. According to the classification system of posttreatment C2-alignment established by our group in part I of the C2-fracture study project, mean malunion score was 2.8 points. In 49% of patients the fractures healed in anatomical shape or with mild malalignment. In 51% fractures healed with moderate or severe malalignment. Self-rated outcome was excellent or good in 65% of patients and moderate or poor in 35%. The raw data of varying nuances allow for comparison in future benchmark studies and metaanalysis. Detailed

  10. Venlafaxine versus applied relaxation for generalized anxiety disorder: a randomized controlled study on clinical and electrophysiological outcomes.

    Science.gov (United States)

    Zullino, Daniele; Chatton, Anne; Fresard, Emmanuelle; Stankovic, Miroslava; Bondolfi, Guido; Borgeat, François; Khazaal, Yasser

    2015-03-01

    Some components of generalized anxiety disorder, such as physical symptoms, are thought to reflect autonomic nervous system arousal. This study primarily assessed the relationships between psychophysiological and clinical measures using venlafaxine extended release or applied relaxation, and secondarily, the impact of combination treatment in patients not remitting after 8 weeks. Fifty-eight patients were randomly assigned to 8 weeks of treatment with either venlafaxine or applied relaxation (Phase I). Non-remitted patients received combination treatment for an additional 8 weeks (Phase II). Assessments included the Hamilton Anxiety Scale (HAM-A), Beck Depression Inventory, Penn State Worry Questionnaire and the Stroop Color-Word Task coupled with electrophysiological measures (skin conductance and frontalis electromyography (EMG)). In Phase 1, a time effect was found for the clinical and skin conductance measures. Thirteen patients from each group were in remission. In Phase 2, seven additional patients remitted. Baseline psychophysiological measures were not associated with baseline clinical variables or with clinical outcomes. Independently of treatment allocation, a reduction in frontal EMG values at week 4 was significantly associated with a decrease in HAM-A scores at week 8. At week 4, responders from the applied relaxation group had lower electrophysiological activity than the venlafaxine group. Baseline psychophysiological measures were not linked with clinical measures at study inclusion or with treatment response. Frontal EMG response at week 4 is a possible predictor of treatment response. Treatment combination enhances treatment response after initial failure.

  11. Exenatide once weekly: clinical outcomes and patient satisfaction

    Directory of Open Access Journals (Sweden)

    Biju Jose1

    2010-08-01

    Full Text Available Biju Jose1, Abd A Tahrani1,2, Milan K Piya1,2, Anthony H Barnett1,21Department of Diabetes and Endocrinology, Heart of England NHS Foundation Trust, Birmingham, UK; 2School of Clinical and Experimental Medicine, University of Birmingham, Birmingham, UKBackground: Type 2 diabetes mellitus (T2DM is a complex disorder in which interactions between environmental and genetic factors result in the development of insulin resistance (in most cases and progressive pancreatic β-cell failure. The currently available oral anti-diabetes treatments are effective as monotherapy; however, due to the progressive decline in β-cell function, most patients will require the use of combination therapy and eventually insulin to reach glycemic targets. These therapeutic options are not without undesirable side effects such as weight gain and hypoglycemia. Furthermore, T2DM is associated with impaired quality of life (QOL and poor compliance with treatment. Hence, there is a need for anti-diabetes agents that result in sustained improvements in glycemic control without hypoglycemia or weight gain and have a positive impact on patients QOL and thereby hopefully improve compliance. Incretin-based therapy is the latest addition to anti-diabetes treatments which addresses some of the shortcomings of older treatments.Aims: To review the evidence for the use of exenatide once-weekly.Methods: We have searched Medline using the terms “exenatide”, “exenatide once-weekly”, and “exenatide LA”.Results: Exenatide once-weekly is an incretin mimetic that is currently undergoing phase 3 clinical trials, and has been shown to improve glycemic parameters (HbA1c and fasting and postprandial glucose levels, with low risk of hypoglycemia, causes weight loss, and use was associated with improvements in patient satisfaction which might have a positive impact on treatment compliance.Conclusions: Exenatide once-weekly is effective, well tolerated in patients with T2DM and should

  12. Patient reported outcomes (PROs in clinical trials: is 'in-trial' guidance lacking? a systematic review.

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    Derek G Kyte

    Full Text Available BACKGROUND: Patient reported outcomes (PROs are increasingly assessed in clinical trials, and guidelines are available to inform the design and reporting of such trials. However, researchers involved in PRO data collection report that specific guidance on 'in-trial' activity (recruitment, data collection and data inputting and the management of 'concerning' PRO data (i.e., data which raises concern for the well-being of the trial participant appears to be lacking. The purpose of this review was to determine the extent and nature of published guidelines addressing these areas. METHODS AND FINDINGS: Systematic review of 1,362 articles identified 18 eligible papers containing 'in-trial' guidelines. Two independent authors undertook a qualitative content analysis of the selected papers. Guidelines presented in each of the articles were coded according to an a priori defined coding frame, which demonstrated reliability (pooled Kappa 0.86-0.97, and validity (<2% residual category coding. The majority of guidelines present were concerned with 'pre-trial' activities (72%, for example, outcome measure selection and study design issues, or 'post-trial' activities (16% such as data analysis, reporting and interpretation. 'In-trial' guidelines represented 9.2% of all guidance across the papers reviewed, with content primarily focused on compliance, quality control, proxy assessment and reporting of data collection. There were no guidelines surrounding the management of concerning PRO data. CONCLUSIONS: The findings highlight there are minimal in-trial guidelines in publication regarding PRO data collection and management in clinical trials. No guidance appears to exist for researchers involved with the handling of concerning PRO data. Guidelines are needed, which support researchers to manage all PRO data appropriately and which facilitate unbiased data collection.

  13. Pramipexole in restless legs syndrome: an evidence-based review of its effectiveness on clinical outcomes

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    William Winlow

    2005-03-01

    Full Text Available William WinlowCore Medical Publishing, Knutsford, UKIntroduction: Restless legs syndrome (RLS affects 5–15% of adults, but is often unrecognized and consequently misdiagnosed. The International Restless Legs Scale (IRLS has been developed and validated to assess the severity of RLS. Currently, the most common treatment for RLS is levodopa, but this may lead to augmentation of symptoms. Pramipexole has been developed as an alternative treatment for patients diagnosed with RLS.Aims: The objective of this article is to review the evidence of the effectiveness of pramipexole for the clinical management of patients with RLS.Evidence review: There is clear evidence that pramipexole reduces the leg movements associated with RLS, as measured by improvements in both the IRLS and the Clinical Global Impression (CGI score. There is also moderate evidence that the drug improves sleep quality. Pramipexole clearly improves the anxiety and depression often associated with RLS. Augmentation may be associated with pramipexole treatment, but the evidence is contradictory and augmentation may be more associated with patients pretreated with levodopa or with patients with primary RLS rather than those with secondary RLS. Pramipexole therapy appears to be well tolerated, with only mild-to-moderate adverse events reported.Outcomes summary: Pramipexole reduces leg movements in RLS, and is well tolerated. Further investigation is required to confirm the preliminary evidence that pramipexole restores normal sleep architecture and restores a normal quality of life in patients with RLS. Health economic studies would be valuable in demonstrating the true impact of pramipexole on the social burden of RLS.Key words: restless legs syndrome (RLS, pramipexole, outcomes, evidence

  14. Can adventurous training have a role in improving clinical outcomes?

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    Mellor, A; Jackson, S; Hardern, R

    2012-06-01

    The aim of military adventurous training (AT) is "to develop, through authorised challenging pursuits and within an outdoor environment, leadership and the qualities necessary to enhance the performance of military personnel during peace and war". An increasing amount of effort is being applied by all three services to increase participation in AT to achieve these, largely immeasurable, aims. Existing guidance to Commanding Officers dictates that, where possible, 20% of a unit strength should undertake some form of AT annually with 5% taking part in an overseas expedition. In a speech in 2008 Alan Johnson, the then Secretary of State for Health, acknowledged that for Armed Forces medical personnel 'just as important as clinical skills are issues such as leadership, communication, adaptability and teamwork." Controlled exposure to risk, discomfort and personal hardship is a common theme for both AT activities and military deployments. Both General Medical Council competencies for all doctors and the Royal College of Anaesthetists military module include elements which can effectively be taught and developed through training in an outdoors environment. These skills include communication skills, leadership, risk assessment and interdisciplinary working. In this review the value of AT in training doctors to develop those attributes is examined.

  15. Clinical Outcomes of Endoscopic Hemostasis in Marginal Ulcer Bleeding.

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    Yamasaki, Yasushi; Takenaka, Ryuta; Hori, Keisuke; Takemoto, Koji; Kawano, Seiji; Kawahara, Yoshiro; Fujiki, Shigeatsu; Okada, Hiroyuki

    2016-12-01

    The usefulness of endoscopy in marginal ulcer bleeding has rarely been studied, and the optimal method for preventing rebleeding is unclear. Here we assessed the efficacy of endoscopy in marginal ulcer bleeding and examined the efficacy of proton pump inhibitors (PPIs) in the prevention of rebleeding. A total of 28 patients with marginal ulcer bleeding (21 men, 7 women; median age 58.5 years) were treated by endoscopy. We analyzed the clinical characteristics, results of endoscopic therapy, characteristics of rebleeding patients, and relation between the use of PPIs and the duration of rebleeding. Sixteen patients had active bleeding. Initial hemostasis was achieved in all patients. There were no procedure-related adverse events. Rebleeding occurred in one patient within the first month and in 7 patients thereafter. There was a significant difference in the rebleeding rate between the patients who received a PPI and those who did not. In a multivariate analysis, the non-use of PPIs was a risk factor for rebleeding (hazard ratio, 6.22). Therapeutic endoscopy is effective in achieving hemostasis from marginal ulcer bleeding. PPIs may prevent rebleeding from marginal ulcers.

  16. Prevalence of Sarcopenia and Associated Outcomes in the Clinical Setting.

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    Peterson, Sarah J; Braunschweig, Carol A

    2016-02-01

    Sarcopenia refers to age-associated decrease in muscle mass and function. The condition was originally described in the elderly, but emerging evidence suggests that it is also a concern among the chronically ill nonelderly. Currently there are a number of definitions for diagnosing sarcopenia; however, in the clinical setting, abdominal computed tomography (CT) scans completed for diagnostic purposes can be utilized to identify CT-defined sarcopenia. Recent studies suggest that prevalence of CT-defined sarcopenia is high among chronically ill patients, ranging from 15%-50% in patients with cancer, 30%-45% with liver failure, and 60%-70% for critically ill patients in the intensive care unit. Depleted muscle mass is associated with infectious complications, prolonged duration of mechanical ventilation, longer hospitalization, greater need for rehabilitation care after hospital discharge, and higher mortality. In consideration of the growing population of older adults with multiple comorbidities, more research is needed to identify sarcopenia and develop interventions that are directed at attenuating or reversal muscle loss.

  17. Clinical Outcomes of Colonic Stent in a Tertiary Care Center

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    Mahesh Gajendran

    2014-01-01

    Full Text Available Introduction. Colonic obstruction is one of the manifestations of colon cancer for which self-expanding metal stents (SEMS have been effectively used, to restore the luminal patency either for palliative care or as a bridge to resective surgery. The aim of our study is to evaluate the efficacy and safety of large diameter SEMS in patients with malignant colorectal obstruction. Methods and Results. A four-year retrospective review of the Medical Archival System was performed and identified 16 patients. The average age was 70.8 years, of which 56% were females. The most common cause of obstruction was colon cancer (9/16, 56%. Rectosigmoid was the main site of obstruction (9/16 and complete obstruction occurred in 31% of cases. The overall technical and clinical success rates were 100% and 87%, respectively. There were no immediate complications (<24 hours, but stent stenosis due to kinking occurred within one week of stent placement in 2 patients. Stent migration occurred in 2 patients at 34 and 91 days, respectively. There were no perforations or bleeding complications. Conclusion. Large diameter SEMS provide a safe method for palliation or as a bridge to therapy in patients with malignant colonic obstruction with high technical success and very low complication rates.

  18. Beyond FEV1 in COPD: a review of patient-reported outcomes and their measurement

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    Jones P

    2012-10-01

    Full Text Available Paul Jones,1 Marc Miravitlles,2 Thys van der Molen,3 Karoly Kulich41Division of Clinical Science, University of London, London, UK; 2Institut d'Investigacions Biomèdiques August Pi i Sunyer, Hospital Clínic, Ciber de Enfermedades Respiratorias, Barcelona, Spain; 3Department of Primary Care, University Medical Centre Groningen, Groningen, The Netherlands; 4Novartis Pharma AG, Basel, SwitzerlandAbstract: Patients with chronic obstructive pulmonary disease (COPD present with a variety of symptoms and pathological consequences. Although primarily viewed as a respiratory disease, COPD has both pulmonary and extrapulmonary effects, which have an impact on many aspects of physical, emotional, and mental well-being. Traditional assessment of COPD relies heavily on measuring lung function, specifically forced expiratory volume in 1 second (FEV1. However, the evidence suggests that FEV1 is a relatively poor correlate of symptoms such as breathlessness and the impact of COPD on daily life. Furthermore, many consequences of the disease, including anxiety and depression and the ability to perform daily activities, can only be described and reported reliably by the patient. Thus, in order to provide a comprehensive view of the effects of interventions in clinical trials, it is essential that spirometry is accompanied by assessments using patient-reported outcome (PRO instruments. We provide an overview of patient-reported outcome concepts in COPD, such as breathlessness, physical functioning, and health status, and evaluate the tools used for measuring these concepts. Particular attention is given to the newly developed instruments emerging in response to recent regulatory guidelines for the development and use of PROs in clinical trials. We conclude that although data from the development and validation of these new PRO instruments are emerging, to build the body of evidence that supports the use of a new instrument takes many years. Furthermore, new

  19. Dietary sodium and clinical outcome in hemodialysis: where do we stand and what is next?

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    Rambod, Mehdi; Tolouian, Ramin

    2012-07-01

    The association of dietary sodium and outcome is widely studied in the general population, but less is known in hemodialysis patients. The evidence supporting daily dietary sodium intake of 2 g on hemodialysis is not strong. Mc Causland et al. found that higher dietary sodium intake was marginally associated with a higher ultrafiltration requirement and mortality, but not with blood pressure. Well-designed clinical trials are needed to examine the association of dietary sodium modification and outcomes in hemodialysis patients.

  20. Soluble Angiotensin Converting Enzyme 2 in Human Heart Failure: Relation with Myocardial Function and Clinical Outcomes

    Science.gov (United States)

    Epelman, Slava; Shrestha, Kevin; Troughton, Richard W.; Francis, Gary S.; Sen, Subha; Klein, Allan L.; Tang, W .H. Wilson

    2011-01-01

    Objective Angiotensin converting enzyme 2 (ACE2) is an endogenous counter-regulator of the renin-angiotensin system. The relationship between soluble ACE2 (sACE2), myocardial function, and clinical outcomes in patients with chronic systolic heart failure is not well established. Methods We measured sACE2 activity in 113 patients with chronic systolic heart failure (left ventricular ejection fraction [LVEF] ≤ 35%, NYHA class II-IV). Comprehensive echocardiography was performed at the time of blood sampling. We prospectively examined adverse clinical events (death, cardiac transplant, and heart failure hospitalizations) over 34 ± 17 months. Results Patients who had higher sACE2 plasma activity were more likely to have a lower LVEF (Spearman’s r= −0.36, p <0.001), greater RV systolic dysfunction (r=0.33, p<0.001), higher estimated pulmonary artery systolic pressure (r=0.35, p=0.002), larger LV end diastolic diameter (r=0.23, p=0.02), and higher plasma NT-proBNP levels (r=0.35, p<0.001). sACE2 was less associated with diastolic dysfunction (r=0.19, p=0.05), and was similar between patients with ischemic and non-ischemic cardiomyopathies. There was no relationship between sACE2 activity and markers of systemic inflammation. After adjusting for NT-proBNP and LVEF, sACE2 activity remained an independent predictor of adverse clinical events (HR=1.7 [95% CI: 1.1 – 2.6], p=0.018). Conclusions Elevated plasma sACE2 activity was associated with greater severity of myocardial dysfunction and was an independent predictor of adverse clinical events. PMID:19700132

  1. Endothelin 1 levels in relation to clinical presentation and outcome of Henoch Schonlein purpura

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    Moustaki M

    2008-09-01

    Full Text Available Abstract Background Henoch Schonlein purpura (HSP is a common vasculitis of small vessels whereas endothelin-1 (ET-1 is usually reported elevated in vasculities and systematic inflammation. The aim of the present study was to investigate whether ET-1 levels are correlated with the clinical presentation and the outcome of HSP. Methods The study sample consisted of thirty consecutive patients with HSP. An equal number of healthy patients of similar age and the same gender were served as controls. The patients' age range was 2–12.6 years with a mean ± SD = 6.3 ± 3 years. All patients had a physical examination with a renal, and an overall clinical score. Blood and urinary biochemistry, immunology investigation, a skin biopsy and ET-1 measurements in blood and urine samples were made at presentation, 1 month later and 1 year after the appearance of HSP. The controls underwent the same investigation with the exception of skin biopsy. Results ET-1 levels in plasma and urine did not differ between patients and controls at three distinct time points. Furthermore the ET-1 were not correlated with the clinical score and renal involvement was independent from the ET-1 measurements. However, the urinary ET-1 levels were a significant predictor of the duration of the acute phase of HSP (HR = 0.98, p = 0.032, CI0.96–0.99. The ET-1 levels did not correlate with the duration of renal involvement. Conclusion Urinary ET-1 levels are a useful marker for the duration of the acute phase of HSP but not for the length of renal involvement.

  2. Association Between Medicare Summary Star Ratings for Patient Experience and Clinical Outcomes in US Hospitals

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    Stephen Trzeciak MD, MPH

    2016-03-01

    Full Text Available Objective: In 2015, the Centers for Medicare and Medicaid Services (CMS released new summary star ratings for US hospitals based on patient experience. We aimed to test the association between CMS patient experience star ratings and clinical outcomes. Methods: We analyzed risk-adjusted data for more than 3000 US hospitals from CMS Hospital Compare using linear regression. Results: We found that better patient experience was associated with favorable clinical outcomes. Specifically, a higher number of stars for patient experience had a statistically significant association with lower rates of many in-hospital complications. A higher patient experience star rating also had a statistically significant association with lower rates of unplanned readmissions to the hospital within 30 days. Conclusion: Better patient experience according to the CMS star ratings is associated with favorable clinical outcomes. These results support the inclusion of patient experience data in the framework of how hospitals are paid for services.

  3. User-centered design in clinical handover: exploring post-implementation outcomes for clinicians.

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    Wong, Ming Chao; Cummings, Elizabeth; Turner, Paul

    2013-01-01

    This paper examines the outcomes for clinicians from their involvement in the development of an electronic clinical hand-over tool developed using principles of user-centered design. Conventional e-health post-implementation evaluations tend to emphasize technology-related (mostly positive) outcomes. More recently, unintended (mostly negative) consequences arising from the implementation of e-health technologies have also been reported. There remains limited focus on the post-implementation outcomes for users, particularly those directly involved in e-health design processes. This paper presents detailed analysis and insights into the outcomes experienced post-implementation by a cohort of junior clinicians involved in developing an electronic clinical handover tool in Tasmania, Australia. The qualitative methods used included observations, semi-structured interviews and analysis of clinical handover notes. Significantly, a number of unanticipated flow-on effects were identified that mitigated some of the challenges arising during the design and implementation of the tool. The paper concludes by highlighting the importance of identifying post-implementation user outcomes beyond conventional system adoption and use and also points to the need for more comprehensive evaluative frameworks to encapsulate these broader socio-technical user outcomes.

  4. Outcomes of Clinical Application of Boomerang Closure Wire System

    Institute of Scientific and Technical Information of China (English)

    Jian-sheng WU; Wen-bin WEI; Yu-jia WANG; Xin-xia ZHANG; Xue-song HU

    2009-01-01

    Objectives To evaluate the efficacy and safety of clinical application of a novel type of vascular closure device named Boomerang closure wire system (BCWS). Methods BCWSs were used in 288 patients (BCWSs group) for hemostasis after transfernoral coronary angiography (CAG) or percutaneous coronary intervention (PCI). Device suc-cess rate, hemostasis success rate, manual compression time, recumbent time, minor peripheral complication rate, se-vere peripheral complication rate and hospital staying time after procedure were analyzed. Results were compared to those from 300 patients (control group) who received manual compression in our hospital during the same period. Results In BCWS group, device success rate was 97.2 %, hemostasis success rate was 95.1%. Manual compression time in CAG subgroup and PCI subgroup was 7.8 min and 11.2 min, respectively. Recumbent time was 136. 3 min in CAG subgroup, 284.6 min in PCI subgroup. Minor peripheral complication rate was 4.5 %, severe peripheral compli-cation rate was 2.4 %. Hospital-staying time after procedure in CAG group and PCI group was 1.8 d and 6.6 d, re-spectively. Compared to control group, manual compression time, recumbent time and hospital-staying time of BCWSs group had statistical significance; hemostasis success rate, minor peripheral complication rate and severe peripheral complication rate of BCWSs group bad no statistical difference. Conclusions BCWS provides satisfied haemostatic effect. Compared to routine manual compression, BCWS shortens manual compression time, recumbent time and hos-pital staying time.

  5. Clinical factors adversely affecting early outcome after brain infarction

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    Charles André

    1994-06-01

    Full Text Available PURPOSE AND METHODS: One-hundred-and-nine consecutive patients admitted during the acute phase of a CT-confirmed brain infarction (BI were studied. Putative adverse influence of demographic and stroke risk factors, previous medical history, clinical presentation, initial and follow-up neurological examination, initial general evaluation, laboratory findings, chest X-ray and electrocardiographic findings, treatment, and topography and etiology of the ischemic insult was analysed. The end-point for assessment was early death (within 30 days. Statistical analysis was performed with univariate analysis and multiple regression. RESULTS: The main adverse factors related to an increased death risk during the first 30 days were, in decreasing order of importance: coma 48-72 hours after admission; stroke occuring in already hospitalized patients; Babinski sign on admission; minor degrees of impairment of consciousness 48-72 hours after admission; stroke related to large artery atherothrombosis and to embolism; a history of early impairment of consciousness; cardiac failure on admission. In 53 lucid patients on admission, only a history of congestive heart failure (CHF was associated with a reduced survival rate. In 56 patients with impaired consciousness, the presence of a Babinski sign increased death risk, but the main factor predicting a high case-fatality rate was the persistence of consciousness disturbances after48-72 hours. CONCLUSIONS: The presence of impairment of consciousness, especially coma, 2-3 days after disease onset, and a history of CHF greatly increase the early case fatality rate in patients with acute BI presenting with or without consciousness disturbances at admission, respectively. The use of a prognostic algorythm considering these few variables seems to predict the approximate 30-day fatality rates.

  6. Outcomes of neuropsychiatric events in systemic lupus erythematosus based on clinical phenotypes; prospective data from the Leiden NP SLE cohort.

    Science.gov (United States)

    Magro-Checa, C; Beaart-van de Voorde, L J J; Middelkoop, H A M; Dane, M L; van der Wee, N J; van Buchem, M A; Huizinga, T W J; Steup-Beekman, G M

    2017-04-01

    Objective The objective of this study was to assess whether clinical and patient's reported outcomes are associated with a different pathophysiological origin of neuropsychiatric events presenting in systemic lupus erythematosus. Methods A total of 232 neuropsychiatric events presenting in 131 systemic lupus erythematosus patients were included. Neuropsychiatric systemic lupus erythematosus diagnosis was established per event by multidisciplinary evaluation. All neuropsychiatric events were divided according to a suspected underlying pathophysiological process into one of the following: non-neuropsychiatric systemic lupus erythematosus related, inflammatory and ischaemic neuropsychiatric systemic lupus erythematosus. The clinical outcome of all neuropsychiatric events was determined by a physician-completed four-point Likert scale. Health-related quality of life was measured with the subscales of the patient-generated Short Form 36 (SF-36) health survey questionnaire. The change between scores at paired visits of all domain scores, mental component summary (SF-36 MCS) and physical component summary (SF-36 PCS) scores were retrospectively calculated and used as patient-reported outcome. The association among these outcomes and the different origin of neuropsychiatric events was obtained using multiple logistic regression analysis. Results The clinical status of 26.8% non-neuropsychiatric systemic lupus erythematosus events, 15.8% ischaemic neuropsychiatric systemic lupus erythematosus and 51.6% inflammatory neuropsychiatric systemic lupus erythematosus improved after re-assessment. Almost all SF-36 domains had a positive change at re-assessment in all groups independently of the origin of neuropsychiatric events. Neuropsychiatric systemic lupus erythematosus ( B = 0.502; p systemic lupus erythematosus ( B = 0.827; p systemic lupus erythematosus ( B = 5.783; p systemic lupus erythematosus ( B = 11.133; p systemic lupus erythematosus events

  7. Achievements in mental health outcome measurement in Australia: Reflections on progress made by the Australian Mental Health Outcomes and Classification Network (AMHOCN

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    Burgess Philip

    2012-05-01

    Full Text Available Abstract Background Australia’s National Mental Health Strategy has emphasised the quality, effectiveness and efficiency of services, and has promoted the collection of outcomes and casemix data as a means of monitoring these. All public sector mental health services across Australia now routinely report outcomes and casemix data. Since late-2003, the Australian Mental Health Outcomes and Classification Network (AMHOCN has received, processed, analysed and reported on outcome data at a national level, and played a training and service development role. This paper documents the history of AMHOCN’s activities and achievements, with a view to providing lessons for others embarking on similar exercises. Method We conducted a desktop review of relevant documents to summarise the history of AMHOCN. Results AMHOCN has operated within a framework that has provided an overarching structure to guide its activities but has been flexible enough to allow it to respond to changing priorities. With no precedents to draw upon, it has undertaken activities in an iterative fashion with an element of ‘trial and error’. It has taken a multi-pronged approach to ensuring that data are of high quality: developing innovative technical solutions; fostering ‘information literacy’; maximising the clinical utility of data at a local level; and producing reports that are meaningful to a range of audiences. Conclusion AMHOCN’s efforts have contributed to routine outcome measurement gaining a firm foothold in Australia’s public sector mental health services.

  8. Comparing clinical outcomes of repeat discectomy versus fusion for recurrent disc herniation utilizing the N(2)QOD.

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    Guan, Jian; Ravindra, Vijay M; Schmidt, Meic H; Dailey, Andrew T; Hood, Robert S; Bisson, Erica F

    2017-01-01

    OBJECTIVE Recurrent lumbar disc herniation (RLDH) is a significant cause of morbidity in patients undergoing lumbar discectomy and has been reported to occur in up to 18% of cases. While repeat discectomy is often successful in treating these patients, concern over repeat RLDH may lead surgeons to advocate instrumented fusion even in the absence of instability. The authors' goal was to compare clinical outcomes for patients undergoing repeat discectomy versus instrumented fusion for RLDH. METHODS The authors used the National Neurosurgery Quality and Outcomes Database (N(2)QOD) to assess outcomes of patients who underwent repeat discectomy versus instrumented fusion at a single institution from 2012 to 2015. Primary outcomes included Oswestry Disability Index (ODI) score, visual analog scale (VAS) score, and quality-adjusted life year (QALY) measures. Secondary outcomes included hospital length of stay, discharge status, and hospital charges. RESULTS The authors identified 25 repeat discectomy and 12 instrumented fusion patients with 3- and 12-month follow-up records. The groups had similar ODI and VAS scores and QALY measurements at 3 and 12 months. Patients in the instrumented fusion group had significantly longer hospitalizations (3.7 days vs 1.0 days, p fusion group were also significantly higher ($54,458.29 vs $11,567.05, p fusion result in similar clinical outcomes at short-term follow-up. Patients undergoing repeat discectomy had significantly shorter operative times and length of stay, and they incurred dramatically lower hospital charges. They were also less likely to require acute rehabilitation postoperatively. Further research is needed to compare these two management strategies.

  9. Clinical capabilities of graduates of an outcomes-based integrated medical program

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    Scicluna Helen A

    2012-06-01

    Full Text Available Abstract Background The University of New South Wales (UNSW Faculty of Medicine replaced its old content-based curriculum with an innovative new 6-year undergraduate entry outcomes-based integrated program in 2004. This paper is an initial evaluation of the perceived and assessed clinical capabilities of recent graduates of the new outcomes-based integrated medical program compared to benchmarks from traditional content-based or process-based programs. Method Self-perceived capability in a range of clinical tasks and assessment of medical education as preparation for hospital practice were evaluated in recent graduates after 3 months working as junior doctors. Responses of the 2009 graduates of the UNSW’s new outcomes-based integrated medical education program were compared to those of the 2007 graduates of UNSW’s previous content-based program, to published data from other Australian medical schools, and to hospital-based supervisor evaluations of their clinical competence. Results Three months into internship, graduates from UNSW’s new outcomes-based integrated program rated themselves to have good clinical and procedural skills, with ratings that indicated significantly greater capability than graduates of the previous UNSW content-based program. New program graduates rated themselves significantly more prepared for hospital practice in the confidence (reflective practice, prevention (social aspects of health, interpersonal skills (communication, and collaboration (teamwork subscales than old program students, and significantly better or equivalent to published benchmarks of graduates from other Australian medical schools. Clinical supervisors rated new program graduates highly capable for teamwork, reflective practice and communication. Conclusions Medical students from an outcomes-based integrated program graduate with excellent self-rated and supervisor-evaluated capabilities in a range of clinically-relevant outcomes. The program

  10. Clinical outcomes of osteomyelitis patients infected with methicillin-resistant Staphylococcus aureus USA-300 strains.

    Science.gov (United States)

    Peyrani, P; Allen, M; Seligson, D; Roberts, C; Chen, A; Haque, N; Zervos, M; Wiemken, T; Harting, J; Christensen, D; Ramirez, R

    2012-03-01

    Methicillin-resistant Staphylococcus aureus (MRSA) USA-300 strains have emerged as an important cause of community-acquired infections. These strains have been recognized as an etiology of osteomyelitis but data on their incidence and outcomes are limited. We retrospectively studied the incidence and clinical outcomes of MRSA USA-300 osteomyelitis in patients at the University of Louisville Hospital and the Henry Ford Health System between January 2007 and March 2008. Pulsed-field gel electrophoresis was used to determine USA type. Clinical outcomes were defined as management success versus failure at 12 months. Chi-square tests, Fisher exact tests, and Mann-Whitney tests were used to compare patient characteristics on the basis of clinical outcomes and USA type. Of the 50 patients with MRSA osteomyelitis, 27 (54%) had the USA-300 strain. Clinical failure was identified in 22% (6/27) of the patients with MRSA USA-300 and in 30% (7/23) of the patients with MRSA non-USA-300 osteomyelitis (P = .509). Our results showed that MRSA USA-300 is a significant etiology of MRSA osteomyelitis. With current surgical and medical management, outcomes of patients with MRSA USA-300 osteomyelitis are similar to those of patients with MRSA non-USA-300 osteomyelitis.

  11. Neurocognitive and clinical predictors of long-term outcome in adolescents at ultra-high risk for psychosis: a 6-year follow-up.

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    Tim Ziermans

    Full Text Available BACKGROUND: Most studies aiming to predict transition to psychosis for individuals at ultra-high risk (UHR have focused on either neurocognitive or clinical variables and have made little effort to combine the two. Furthermore, most have focused on a dichotomous measure of transition to psychosis rather than a continuous measure of functional outcome. We aimed to investigate the relative value of neurocognitive and clinical variables for predicting both transition to psychosis and functional outcome. METHODS: Forty-three UHR individuals and 47 controls completed an extensive clinical and neurocognitive assessment at baseline and participated in long-term follow-up approximately six years later. UHR adolescents who had converted to psychosis (UHR-P; n = 10 were compared to individuals who had not (UHR-NP; n = 33 and controls on clinical and neurocognitive variables. Regression analyses were performed to determine which baseline measures best predicted transition to psychosis and long-term functional outcome for UHR individuals. RESULTS: Low IQ was the single neurocognitive parameter that discriminated UHR-P individuals from UHR-NP individuals and controls. The severity of attenuated positive symptoms was the only significant predictor of a transition to psychosis and disorganized symptoms were highly predictive of functional outcome. CONCLUSIONS: Clinical measures are currently the most important vulnerability markers for long-term outcome in adolescents at imminent risk of psychosis.

  12. Early clinical outcome and complications related to balloon kyphoplasty

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    Martin Bergmann

    2012-06-01

    Full Text Available The treatment of painful osteoporotic vertebral compression fractures using transpedicular cement augmentation has grown significantly over the last two decades. The benefits of balloon kyphoplasty compared to conservative treatment remain controversial and are discussed in the literature. The complication rates of vertebroplasty and kyphoplasty are considered to be low. The focus of this study was the analysis of acute and clinically relevant complications related to this procedure. In our department, all patients treated between February 2002 and February 2011 with percutaneous cement augmentation (372 patients, 522 augmented vertebral bodies were prospectively recorded. Demographic data, comorbidities, fracture types, intraoperative data and all complications were documented. The pre- and postoperative pain-level and neurological status (Frankel-Score were evaluated. All patients underwent a standardized surgical procedure. Two hundred and ninety-seven patients were treated solely by balloon kyphoplasty; 216 females (72.7% and 81 males (27.3%. Average patient age was 76.21 years (±10.71, range 35-98 years. Average American Society Anestesiologists score was 3.02. According to the Orthopedic Trauma Association classification, there were 69 A 1.1 fractures, 177 A 1.2 fractures, 178 A 3.1.1 fractures and 3 A 3.1.3 fractures. Complications were divided into preoperative, intraoperative and postoperative events. There were 4 pre-operative complications: 3 patients experienced persistent pain after the procedure. In one case, the pedicles could not be visualized during the procedure and the surgery was terminated. One hundred and twenty-nine (40.06% of the patients showed intraoperative cement leaking outside the vertebras, one severe hypotension and tachycardia as reaction to the inflation of the balloons, and there was one cardiac arrest during surgery. Postoperative subcutaneous hematomas were observed in 3 cases, 13 patients developed a

  13. Objective measures of subjective experience: the use of therapist notes in process-outcome research.

    Science.gov (United States)

    Bucci, Wilma; Maskit, Bernard; Hoffman, Leon

    2012-06-01

    Computerized linguistic measures of emotional engagement, and reflective and affective language, previously applied to session transcripts, were applied to notes of 14 treatments by candidates under supervision at the New York Psychoanalytic Society and Institute, covering the five decades from the 1950s to the 1990s. The findings indicate a strong relationship between candidates' subjective experience as represented unintentionally in the linguistic style of their case notes and the effectiveness of their clinical work. The treatments were evaluated for effectiveness by experienced clinicians using the Global Assessment of Functioning (GAF) and the Psychodynamic Functioning Scales of Høglend and colleagues; a Composite Clinical Effectiveness (CCE) measure was constructed based on level and change in these measures. The Mean High Weighted Referential Activity Dictionary (MHW), a computerized measure of emotional engagement developed in the framework of Bucci's theory of multiple coding and the referential process, showed a positive correlation of .73 with CCE. The Hostility subcategory of the Negative Affect Dictionary (ANH) showed a negative correlation, -.48, with CCE. In a multiple regression analysis, these two variables accounted for over three-quarters of the variance in the CCE. Implications of the findings for process/outcome research and supervision and evaluation of trainees are discussed.

  14. Connecting Stuttering Management and Measurement: V. Deduction and Induction in the Development of Stuttering Treatment Outcome Measures and Stuttering Treatments

    Science.gov (United States)

    Onslow, Mark

    2006-01-01

    Background: The development of evidence-based practice, which is increasingly popular in stuttering treatment, is closely linked to the development of outcome measures. Aims: Two approaches to the development of stuttering treatment outcome measures are outlined. The first is the deductive, top-down approach, where the development of specific…

  15. Correlation of clinical outcome to the estimated radiation dose from Boron Neutron Capture Therapy (BNCT)

    Energy Technology Data Exchange (ETDEWEB)

    Chadha, M. [Beth Israel Medical Center, NY (United States). Dept. of Radiation Oncology; Coderre, J.A.; Chanana, A.D. [Brookhaven National Lab., Upton, NY (United States)] [and others

    1996-12-31

    A phase I/II trial delivering a single fraction of BNCT using p-Boronophenylalanine-Fructose and epithermal neutrons at the the Brookhaven Medical Research Reactor was initiated in September 1994. The primary endpiont of the study was to evaluate the feasibility and safety of a given BNCT dose. The clinical outcome of the disease was a secondary endpoint of the study. The objective of this paper is to evaluate the correlation of the clinical outcome of patients to the estimated radiation dose from BNCT.

  16. Patient-reported outcome measures in a population of medically indigent patients with systemic lupus erythematosus in Puerto Rico

    Science.gov (United States)

    Rodríguez-Rivera, Diana V; Rodríguez-Navedo, Yerania; Nieves-Plaza, Mariely; Vilá, Luis M

    2016-01-01

    Objective: To determine patient-reported outcomes measures in indigent patients with systemic lupus erythematosus receiving their healthcare through the Puerto Rico government managed care system and compare these measures with non-indigent patients treated in a private fee-for-service setting. Methods: A cross-sectional study was conducted in a cohort of 98 Puerto Ricans with systemic lupus erythematosus. Patients from the public group (n = 40) were treated in a university-based specialized systemic lupus erythematosus clinic and the private group (n = 58) in a community-based rheumatology practice. Demographic and clinical features and patient-reported outcomes measures per LupusPRO instrument were determined. LupusPRO captures quality-of-life measures in 12 domains. Differences among study groups were examined using chi-square, Fisher’s exact, t-tests, and the Wilcoxon signed-rank test. Results: The mean (standard deviation) age of the study population was 44.9 (12.0) years; 94 (95.9%) were women. Patients in the public setting were younger and were more likely to have renal disease and elevated anti-double-stranded DNA antibodies, and being treated with azathioprine and cyclophosphamide. Patients from the public sector were more likely to have better quality-of-life measures in the LupusPRO domains of pain/vitality and coping. No significant differences were observed for the domains of lupus symptoms, physical health, emotional health, body image, cognition, procreation, lupus medications, desires/goals, social support, and satisfaction with medical care. Conclusion: Despite having a lower socioeconomic status and worse clinical status, systemic lupus erythematosus patients from the public sector had equal or better patient-reported outcomes measures than those treated in the private setting. This favorable outcome may be associated with the comprehensive healthcare received by these patients in a specialized lupus clinic.

  17. Near-infrared spectroscopy in schizophrenia: A possible biomarker for predicting clinical outcome and treatment response

    Directory of Open Access Journals (Sweden)

    Shinsuke eKoike

    2013-11-01

    Full Text Available Functional near-infrared spectroscopy (fNIRS is a relatively new technique that can measure hemoglobin changes in brain tissues, and its use in psychiatry has been progressing rapidly. Although it has several disadvantages (e.g., relatively low spatial resolution and the possibility of shallow coverage in the depth of brain regions compared with other functional neuroimaging techniques (e.g., functional magnetic resonance imaging and positron emission tomography, fNIRS may be a candidate instrument for clinical use in psychiatry, as it can measure brain activity in naturalistic position easily and noninvasively. fNIRS instruments are also small and work silently, and can be moved almost everywhere including schools and care units. Previous fNIRS studies have shown that patients with schizophrenia have impaired activity and characteristic waveform patterns in the prefrontal cortex during the letter version of the verbal fluency task, and part of these results have been approved as one of the Advanced Medical Technologies as an aid for the differential diagnosis of depressive symptoms by the Ministry of Health, Labor and Welfare of Japan in 2009, which was the first such approval in the field of psychiatry. Moreover, previous studies suggest that the activity in the frontopolar prefrontal cortex is associated with their functions in chronic schizophrenia and is its next candidate biomarker. Future studies aimed at exploring fNIRS differences in various clinical stages, longitudinal changes, drug effects, and variations during different task paradigms will be needed to develop more accurate biomarkers that can be used to aid differential diagnosis, the comprehension of the present condition, the prediction of outcome, and the decision regarding treatment options in schizophrenia. Future fNIRS researches will require standardized measurement procedures, probe settings, analytical methods and tools, manuscript description, and database systems in an

  18. Plasma n-3 fatty acids and clinical outcomes in recent-onset rheumatoid arthritis.

    Science.gov (United States)

    Proudman, Susanna M; Cleland, Leslie G; Metcalf, Robert G; Sullivan, Thomas R; Spargo, Llewellyn D; James, Michael J

    2015-09-28

    A randomised controlled trial (RCT) of high-dose v. low-dose fish oil in recent-onset rheumatoid arthritis (RA) demonstrated that the group allocated to high-dose fish oil had increased remission and decreased failure of disease-modifying anti-rheumatic drug (DMARD) therapy. This study examines the relationships between plasma phospholipid levels of the n-3 fatty acids in fish oil, EPA and DHA, and remission and DMARD use in recent-onset RA. EPA and DHA were measured in blood samples from both groups of the RCT. The data were analysed as a single cohort, and Cox proportional hazards models were used to examine relationships between plasma phospholipid (PL) EPA and DHA and various outcome measures. When analysed as a single cohort, plasma PL EPA was related to time to remission, with a one unit increase in EPA (1% total fatty acids) associated with a 12% increase in the probability of remission at any time during the study period (hazard ratio (HR)=1.12; 95% CI 1.02, 1.23; P=0.02). Adjustment for smoking, anti-cyclic citrullinated peptide antibodies and 'shared epitope' HLA-DR allele status did not change the HR. Plasma PL EPA, adjusted for the same variables, was negatively related to time to DMARD failure (HR=0.85; 95% CI 0.72, 0.99; P=0.047). The HR for DHA and time to remission or DMARD failure were similar in magnitude to those for EPA, but not statistically significant. Biomarkers of n-3 status, such as plasma PL EPA, have the potential to predict clinical outcomes relevant to standard drug treatment of RA patients.

  19. No association between anxiety and depression and adverse clinical outcome among patients with cardiovascular disease

    DEFF Research Database (Denmark)

    Kornerup, Henriette; Zwisler, Ann-Dorthe Olsen; Prescott, Eva

    2011-01-01

    Anxiety and depression have been linked to adverse prognostic outcome in patients with cardiovascular disease (CVD) with mixed results. The timing of anxiety and depression measurement has received little attention so far.......Anxiety and depression have been linked to adverse prognostic outcome in patients with cardiovascular disease (CVD) with mixed results. The timing of anxiety and depression measurement has received little attention so far....

  20. Disease Progression/Clinical Outcome Model for Castration-Resistant Prostate Cancer in Patients Treated with Eribulin

    NARCIS (Netherlands)

    Van Hasselt, J. G C; Gupta, A.; Hussein, Z.; Beijnen, J. H.; Schellens, J. H M; Huitema, A. D R

    2015-01-01

    Frameworks that associate cancer dynamic disease progression models with parametric survival models for clinical outcome have recently been proposed to support decision making in early clinical development. Here we developed such a disease progression clinical outcome model for castration-resistant

  1. Quality of life as an outcome measure in surgical oncology

    NARCIS (Netherlands)

    Langenhoff, B S; Krabbe, P F; Wobbes, T; Ruers, T J

    2001-01-01

    BACKGROUND: There is a growing interest in assessing the impact of a disease and the effect of a treatment on a patient's life, expressed as health-related quality of life (HRQoL). HRQoL assessment can provide essential outcome information for cancer surgery. METHODS: The core of this review is deri

  2. Outcome Measures of Triple Board Graduates, 1991-2003

    Science.gov (United States)

    Warren, Marla J.; Dunn, David W.; Rushton, Jerry

    2006-01-01

    Objective: To describe program outcomes for the Combined Training Program in Child and Adolescent Psychiatry, Pediatrics, and Psychiatry (Triple Board Program). Method: All Triple Board Program graduates to date (1991-2003) were asked to participate in a 37-item written survey from February to April 2004. Results: The response rate was 80.7%. Most…

  3. Predictors and clinical outcomes for spontaneous rupture of hepatocellular carcinoma

    Institute of Scientific and Technical Information of China (English)

    Qian Zhu; Jing Li; Jian-Jun Yan; Liang Huang; Meng-Chao Wu; Yi-Qun Yan

    2012-01-01

    AIM:To determine the risk factors for hepatocellular carcinoma (HCC) rupture,and report the management and long-term survival results of patients with spontaneous rupture of HCC.METHODS:Among 4209 patients with HCC who were diagnosed at Eastern Hepatobiliary Surgery Hospital from April 2002 to November 2006,200 (4.8%) patients with ruptured HCC (case group) were studied retrospectively in term of their clinical characteristics and prognostic factors.The one-stage therapeutic approach to manage ruptured HCC consisted of initial management by conservative treatment,transarterial embolization (TACE) or hepatic resection.Results of various treatments in the case group were evaluated and compared with the control group (202 patients) without ruptured HCC during the same study period.Continuous data were expressed as mean ± SD or median (range) where appropriate and compared using the unpaired t test.Categorical variables were compared using the Chi-square test with Yates correction or the Fisher exact test where appropriate.The overall survival rate in each group was determined using the Kaplan-Meier method and a log-rank test.RESULTS:Compared with the control group,more patients in the case group had underlying diseases of hypertension (7.5% vs 3.0%,P =0.041) and liver cirrhosis (87.5% vs 56.4%,P < 0.001),tumor size >5 cm (83.0% vs 57.4%,P < 0.001),tumor protrusion from the liver surface (66.0% vs 44.6%,P < 0.001),vascular thrombus (30.5% vs 8.9%,P < 0.001) and extrahepatic invasion (36.5% vs 12.4%,P < 0.001).On multivariate logistic regression analysis,underlying diseases of hypertension (P =0.002) and liver cirrhosis (P < 0.001),tumor size > 5 cm (P < 0.001),vascular thrombus (P =0.002) and extrahepatic invasion (P< 0.001) were predictive for spontaneous rupture of HCC.Among the 200 patients with spontaneous rupture of HCC,105 patients underwent hepatic resection,33 received TACE,and 62 were managed with conservative

  4. Assessment set for evaluation of clinical outcomes in multiple sclerosis: psychometric properties

    Directory of Open Access Journals (Sweden)

    Rasova K

    2012-10-01

    Full Text Available Kamila Rasova,1 Patricia Martinkova,2 Jana Vyskotova,3 Michaela Sedova21Department of Rehabilitation, 3rd Faculty of Medicine, Charles University in Prague and Faculty Hospital Královské Vinohrady, Prague, Czech Republic; 2Center of Biomedical Informatics and Department of Medical Informatics and Biostatistics, Institute of Computer Science, AS CR, Prague, Czech Republic; 3Faculty of Medicine, Ostrava University, Ostrava, Czech RepublicPurpose: Multiple sclerosis (MS manifests itself in a wide range of symptoms. Physiotherapy plays an important role in the treatment of those symptoms connected with mobility. For this therapy to be at its most effective it should be based on a systematic examination that is able to describe and classify damaged clinical functions meaningfully. The purpose of this study was to develop and validate a battery of tests and composite tests that can be used to systematically evaluate clinical features of MS treatable by physiotherapy.Methods: The authors assembled a proposed battery of tests comprising known, standard, and validated assessments (low-contrast letter acuity testing; the Motricity Index; the Modified Ashworth Scale; the Berg Balance Scale; scales of postural reactions, tremor, dysdiadochokinesia, and dysmetria; the Nine-Hole Peg Test; the Timed 25-Foot Walk; and the 3-minute version of the Paced Auditory Serial Addition Test and one test (knee hyperextension of the authors’ own. Normalization was calculated and six composite assessments were measured. Seventeen ambulatory subjects with MS were tested twice with the assessment set before undergoing physiotherapy, and 12 were also tested with the assessment set after the physiotherapy. The test–retest reliability, stability, internal consistency of composite measurements, sensitivity to changes after therapy, and correlation between measurements and the Kurtzke Expanded Disability Status Scale score were evaluated for all tests in the assessment set

  5. Bariatric Surgery in the United Kingdom: A Cohort Study of Weight Loss and Clinical Outcomes in Routine Clinical Care.

    Directory of Open Access Journals (Sweden)

    Ian J Douglas

    2015-12-01

    Full Text Available Bariatric surgery is becoming a more widespread treatment for obesity. Comprehensive evidence of the long-term effects of contemporary surgery on a broad range of clinical outcomes in large populations treated in routine clinical practice is lacking. The objective of this study was to measure the association between bariatric surgery, weight, body mass index, and obesity-related co-morbidities.This was an observational retrospective cohort study using data from the United Kingdom Clinical Practice Research Datalink. All 3,882 patients registered in the database and with bariatric surgery on or before 31 December 2014 were included and matched by propensity score to 3,882 obese patients without surgery. The main outcome measures were change in weight and body mass index over 4 y; incident diagnoses of type 2 diabetes mellitus (T2DM, hypertension, angina, myocardial infarction (MI, stroke, fractures, obstructive sleep apnoea, and cancer; mortality; and resolution of hypertension and T2DM. Weight measures were available for 3,847 patients between 1 and 4 mo, 2,884 patients between 5 and 12 mo, and 2,258 patients between 13 and 48 mo post-procedure. Bariatric surgery patients exhibited rapid weight loss for the first four postoperative months, at a rate of 4.98 kg/mo (95% CI 4.88-5.08. Slower weight loss was sustained to the end of 4 y. Gastric bypass (6.56 kg/mo and sleeve gastrectomy (6.29 kg/mo were associated with greater initial weight reduction than gastric banding (2.77 kg/mo. Protective hazard ratios (HRs were detected for bariatric surgery for incident T2DM, 0.68 (95% CI 0.55-0.83; hypertension, 0.35 (95% CI 0.27-0.45; angina, 0.59 (95% CI 0.40-0.87;MI, 0.28 (95% CI 0.10-0.74; and obstructive sleep apnoea, 0.55 (95% CI 0.40-0.87. Strong associations were found between bariatric surgery and the resolution of T2DM, with a HR of 9.29 (95% CI 6.84-12.62, and between bariatric surgery and the resolution of hypertension, with a HR of 5.64 (95% CI

  6. Clinical outcomes of end stage renal disease and adequacy of adult maintenance hemodialysis patients

    OpenAIRE

    Ismail Mahmud Ali, Amirthalingam R

    2014-01-01

    Background & Aim: End stage renal disease (ESRD) is an irreversible loss of kidney function caused by various risk factors and affected persons of lives mainly depending on the technology of renal replacement therapy (RRT) or renal transplantation (RT) to sustain the life. Aim of this study is to overview the clinical outcomes of ESRD and adequacy of maintenance hemodialysis among the patients. Materials & Methods: Currently, there are sixty two end stage renal disease patient’s clinical data...

  7. INFLUENCE OF THE SAGITTAL BALANCE ON THE CLINICAL OUTCOME IN SPINAL FUSION

    OpenAIRE

    2016-01-01

    ABSTRACT Objective: Evaluates which radiographic parameters of the sagittal and spinopelvic balance influence the clinical and functional outcomes of a sample of patients undergoing spinal fusion. Methods: We studied 32 patients who underwent spinal fusion. Radiographs of the total spine were obtained from all patients. The clinical and functional parameters studied were analysis of pain by visual analogic scale (VAS) and Oswestry and SRS-30 questionnaires. We analyzed the correlation bet...

  8. Association between susceptible genotypes to periodontitis and clinical outcomes of periodontal regenerative therapy: a systematic review

    OpenAIRE

    Chatzopoulos, Georgios S.; Koidou, Vasiliki-Petros

    2016-01-01

    Background The aim of this review is to systematically investigate the effect of a susceptible genotype to periodontitis with the clinical outcomes of periodontal regeneration. Material and Methods Based on a focused question, an electronic search identified 155 unique citations. Three journals (Journal of Periodontology, Journal of Clinical Periodontology and Journal of Periodontal Research), references of relevant studies and review articles were hand-searched. Two independent reviewers imp...

  9. Utility of pharmacists on clinical outcomes of patients in palliative care: A short review

    OpenAIRE

    Brkić, Jovana; Tasić, Ljiljana; id_orcid 0000-0001-9584-0341; Krajnović, Dušanka

    2014-01-01

    Pharmacists as the most accessible health care professionals in outpatient settings can improve palliative patient care. The aim of this review was to assess utility of pharmacists (the effectiveness of pharmacists' interventions) on clinical outcomes of patients in palliative care at all levels of health care and in home care. Two electronic databases were searched: PubMed and SCOPUS (last searched August 2014). Primary studies, of any type of research design, in English, related to clinical...

  10. Persistent systemic inflammation is associated with poor clinical outcomes in COPD: a novel phenotype.

    Directory of Open Access Journals (Sweden)

    Alvar Agustí

    Full Text Available BACKGROUND: Because chronic obstructive pulmonary disease (COPD is a heterogeneous condition, the identification of specific clinical phenotypes is key to developing more effective therapies. To explore if the persistence of systemic inflammation is associated with poor clinical outcomes in COPD we assessed patients recruited to the well-characterized ECLIPSE cohort (NCT00292552. METHODS AND FINDINGS: Six inflammatory biomarkers in peripheral blood (white blood cells (WBC count and CRP, IL-6, IL-8, fibrinogen and TNF-α levels were quantified in 1,755 COPD patients, 297 smokers with normal spirometry and 202 non-smoker controls that were followed-up for three years. We found that, at baseline, 30% of COPD patients did not show evidence of systemic inflammation whereas 16% had persistent systemic inflammation. Even though pulmonary abnormalities were similar in these two groups, persistently inflamed patients during follow-up had significantly increased all-cause mortality (13% vs. 2%, p<0.001 and exacerbation frequency (1.5 (1.5 vs. 0.9 (1.1 per year, p<0.001 compared to non-inflamed ones. As a descriptive study our results show associations but do not prove causality. Besides this, the inflammatory response is complex and we studied only a limited panel of biomarkers, albeit they are those investigated by the majority of previous studies and are often and easily measured in clinical practice. CONCLUSIONS: Overall, these results identify a novel systemic inflammatory COPD phenotype that may be the target of specific research and treatment.

  11. Nursing Education Interventions for Managing Acute Pain in Hospital Settings: A Systematic Review of Clinical Outcomes and Teaching Methods.

    Science.gov (United States)

    Drake, Gareth; de C Williams, Amanda C

    2017-02-01

    The objective of this review was to examine the effects of nursing education interventions on clinical outcomes for acute pain management in hospital settings, relating interventions to health care behavior change theory. Three databases were searched for nursing education interventions from 2002 to 2015 in acute hospital settings with clinical outcomes reported. Methodological quality was rated as strong, moderate, or weak using the Effective Public Health Practice Project Quality Assessment Tool for quantitative studies. The 12 eligible studies used varied didactic and interactive teaching methods. Several studies had weaknesses attributable to selection biases, uncontrolled confounders, and lack of blinding of outcome assessors. No studies made reference to behavior change theory in their design. Eight of the 12 studies investigated nursing documentation of pain assessment as the main outcome, with the majority reporting positive effects of education interventions on nursing pain assessment. Of the remaining studies, two reported mixed findings on patient self-report of pain scores as the key measure, one reported improvements in patient satisfaction with pain management after a nursing intervention, and one study found an increase in nurses' delivery of a relaxation treatment following an intervention. Improvements in design and evaluation of nursing education interventions are suggested, drawing on behavior change theory and emphasizing the relational, contextual, and emotionally demanding nature of nursing pain management in hospital settings.

  12. Comprehensive clinical evaluation as an outcome assessment for a graduate orthodontics program.

    Science.gov (United States)

    Pinskaya, Yuliya B; Hsieh, Tsung-Ju; Roberts, W Eugene; Hartsfield, James K

    2004-11-01

    To supplement the American Board of Orthodontics (ABO) objective grading system (OGS) for posttreatment dental casts and panoramic radiographs, a comprehensive clinical assessment (CCA) method was developed to assess facial form, dental esthetics, vertical dimension, arch form, periodontium preservation, root resorption, and treatment efficiency. The sum of the CCA and the ABO OGS scores was defined as the clinical outcome. To determine a 3-year baseline for treatment outcomes in a graduate orthodontic program, the posttreatment records of 521 consecutive patients were evaluated. The mean ABO OGS score for the entire sample was 34.4 points: 32.4, 33.1, and 37.8 points for 1998, 1999, and 2000, respectively. The mean CCA score for the entire sample was 4.67 points: 2.96, 5.13, and 6.15 points for 1998, 1999, and 2000, respectively. Corresponding ABO OGS and CCA scores showed a progressive decrease in the quality of finished cases that was associated with a treatment time increase from 28.9 to 39.3 months. Overall, longer active treatment times resulted in a diminished clinical outcome, primarily due to "patient burn-out." Scoring of all finished cases is an effective means for determining clinical outcomes. However, the data suggest that, in initiating a clinical grading program, it is important to establish a multiyear baseline. Patients who are progressing well in treatment tend to be finished by the time the current class graduates, and the problem patients are transferred. Because long treatment times are associated with diminished clinical outcomes, it is often in the best interest of the uncooperative patient to terminate treatment rather than extend active mechanics in an attempt to achieve a better result.

  13. Leveraging epidemiology and clinical studies of cancer outcomes: recommendations and opportunities for translational research.

    Science.gov (United States)

    Elena, Joanne W; Travis, Lois B; Simonds, Naoko I; Ambrosone, Christine B; Ballard-Barbash, Rachel; Bhatia, Smita; Cerhan, James R; Hartge, Patricia; Heist, Rebecca S; Kushi, Lawrence H; Lash, Timothy L; Morton, Lindsay M; Onel, Kenan; Pierce, John P; Robison, Leslie L; Rowland, Julia H; Schrag, Deborah; Sellers, Thomas A; Seminara, Daniela; Shu, Xiao Ou; Thomas, Nancy E; Ulrich, Cornelia M; Freedman, Andrew N

    2013-01-16

    As the number of cancer survivors continues to grow, research investigating the factors that affect cancer outcomes, such as disease recurrence, risk of second malignant neoplasms, and the late effects of cancer treatments, becomes ever more important. Numerous epidemiologic studies have investigated factors that affect cancer risk, but far fewer have addressed the extent to which demographic, lifestyle, genomic, clinical, and psychosocial factors influence cancer outcomes. To identify research priorities as well as resources and infrastructure needed to advance the field of cancer outcomes and survivorship research, the National Cancer Institute sponsored a workshop titled "Utilizing Data from Cancer Survivor Cohorts: Understanding the Current State of Knowledge and Developing Future Research Priorities" on November 3, 2011, in Washington, DC. This commentary highlights recent findings presented at the workshop, opportunities to leverage existing data, and recommendations for future research, data, and infrastructure needed to address high priority clinical and research questions. Multidisciplinary teams that include epidemiologists, clinicians, biostatisticians, and bioinformaticists will be essential to facilitate future cancer outcome studies focused on improving clinical care of cancer patients, identifying those at high risk of poor outcomes, and implementing effective interventions to ultimately improve the quality and duration of survival.

  14. Clinical presentation and treatment outcome of retinoblastoma in children of South Western China.

    Science.gov (United States)

    Gao, Jingge; Zeng, Jihong; Guo, Bo; He, Weimin; Chen, Jun; Lu, Fang; Chen, Danian

    2016-10-01

    To study the clinical presentation and treatment outcome among children in South Western China with retinoblastoma (RB) and to determine factors predictive of poor outcome.A retrospective review of children diagnosed with RB from 2006 to 2015 at West China Hospital was undertaken. Demographic and clinical characteristics and treatment outcomes were studied.A total of 253 patients (unilateral 80.2%, bilateral 19.8%) were studied. Twenty six patients (10.3%) were from minority ethnic groups of China. The median onset age was 21 months. Leukocoria was the most common presenting sign (71%). Tumors were intraocular in 91.3% cases, extraocular in 8.7% cases. Extraocular RB patients had a longer median lag period than intraocular patients (9 months vs 2 months, P presentation is related to extraocular RB which is a risk factor for poor outcome. Chemotherapy increased the eye salvage but had no effects to overall survival. Education for parents and general physicians for the early signs of RB (such as leukocoria), therapeutic strategy and treatment outcomes of RB may promote early diagnosis, improve the compliance, and outcome.

  15. Defining the clinical outcome status (COS) in sarcoidosis: results of WASOG Task Force.

    Science.gov (United States)

    Baughman, R P; Nagai, S; Balter, M; Costabel, U; Drent, M; du Bois, R; Grutters, J C; Judson, M A; Lambiri, I; Lower, E E; Muller-Quernheim, J; Prasse, A; Rizzato, G; Rottoli, P; Spagnolo, P; Teirstein, A

    2011-07-01

    The clinical outcome of sarcoidosis is quite variable. Several scoring systems have been used to assess the level of disease and clinical outcome. The definition of clinical phenotypes has become an important goal as genetic studies have identified distinct genotypes associated with different clinical phenotypes. In addition, treatment strategies have been developed for patients with resolving versus non resolving disease. A task force was established by the World Association of Sarcoidosis and Other Granulomatous diseases (WASOG) to define clinical phenotypes of the disease based on the clinical outcome status (COS). The committee chose to examine patients five years after diagnosis to determine the COS. Several features of the disease were incorporated into the final nine categories of the disease. These included the current or past need for systemic therapy, the resolution of the disease, and current status of the condition. Sarcoidosis patients who were African American or older were likely to have a higher COS, indicating more chronic disease. The COS may be useful in future studies of sarcoidosis.

  16. Predicting stroke outcome using DCE-CT measured blood velocity

    Science.gov (United States)

    Oosterbroek, Jaap; Bennink, Edwin; Dankbaar, Jan Willem; Horsch, Alexander D.; Viergever, Max A.; Velthuis, Birgitta K.; de Jong, Hugo W. A. M.

    2015-03-01

    CT plays an important role in the diagnosis of acute stroke patients. Dynamic contrast enhanced CT (DCE-CT) can estimate local tissue perfusion and extent of ischemia. However, hemodynamic information of the large intracranial vessels may also be obtained from DCE-CT data and may contain valuable diagnostic information. We describe a novel method to estimate intravascular blood velocity (IBV) in large cerebral vessels using DCE-CT data, which may be useful to help predict stroke outcome. DCE-CT scans from 34 patients with isolated M1 occlusions were included from a large prospective multi-center cohort study of patients with acute ischemic stroke. Gaussians fitted to the intravascular data yielded the time-to-peak (TTP) and cerebral-blood-volume (CBV). IBV was computed by taking the inverse of the TTP gradient magnitude. Voxels with a CBV of at least 10% of the CBV found in the arterial input function were considered part of a vessel. Mid-sagittal planes were drawn manually and averages of the IBV over all vessel-voxels (arterial and venous) were computed for each hemisphere. Mean-hemisphere IBV differences, mean-hemisphere TTP differences, and hemisphere vessel volume differences were used to differentiate between patients with good and bad outcome (modified Rankin Scale score <3 versus ≥3 at 90 days) using ROC analysis. AUCs from the ROC for IBV, TTP, and vessel volume were 0.80, 0.67 and 0.62 respectively. In conclusion, IBV was found to be a better predictor of patient outcome than the parameters used to compute it and may be a promising new parameter for stroke outcome prediction.

  17. Establishing construct validity for the thyroid-specific patient reported outcome measure (ThyPRO)

    DEFF Research Database (Denmark)

    Watt, Torquil; Bjorner, Jakob Bue; Groenvold, Mogens;

    2009-01-01

    To establish a reliable and valid scale structure of a patient-reported outcome measuring thyroid-specific quality of life.......To establish a reliable and valid scale structure of a patient-reported outcome measuring thyroid-specific quality of life....

  18. Nonprofit Organizations and Outcome Measurement: From Tracking Program Activities to Focusing on Frontline Work

    Science.gov (United States)

    Benjamin, Lehn M.

    2012-01-01

    Why do we continue to see evidence that nonprofit staff feel like outcome measurement is missing important aspects of their work? Based on an analysis of over 1,000 pages of material in 10 outcome measurement guides and a focused literature review of frontline work in three types of nonprofit organizations, this article shows that existing outcome…

  19. Clinical Features and Treatment Outcomes of Childhood Autoimmune Hemolytic Anemia: A Retrospective Analysis of 68 Cases.

    Science.gov (United States)

    Fan, Junjie; He, Hailong; Zhao, Wenli; Wang, Yi; Lu, Jun; Li, Jie; Li, Jianqin; Xiao, Peifang; Lu, Ye; Chai, Yihuan; Hu, Shaoyan

    2016-03-01

    Autoimmune hemolytic anemia (AIHA) is a rare disease in children, and its clinical severity varies. To better understand disease manifestation and treatment outcome, we analyzed 68 children diagnosed as AIHA for clinical characteristics, laboratory findings, and treatment outcomes. Data show that primary AIHA accounted for 39.7% of all patients, whereas secondary AIHA accounted for 60.3%. Among them, Evans syndrome (ES) accounted for 20 cases (29.4%). Average hemoglobin was lower in the 1-year or below age group than in the above 1-year age group, combined-antibody group than single-antibody group, and IgM-contained group than non-IgM-contained group (Panemia correlates with age and serologic types of direct antiglobulin test. Glucocorticoid is efficacious for AIHA regardless of whether it is a first attack or relapse in this cohort of young patients. ES needs longer treatment duration. IVIG does not improve the outcome of AIHA.

  20. Influence of Septal Thickness on the Clinical Outcome After Alcohol Septal Alation in Hypertrophic Cardiomyopathy

    DEFF Research Database (Denmark)

    Jensen, Morten K; Jacobsson, Linda; Almaas, Vibeke;

    2016-01-01

    BACKGROUND: We assessed the influence of interventricular septal thickness (IVSd) on the clinical outcome and survival after alcohol septal ablation (ASA) in patient with hypertrophic cardiomyopathy. METHODS AND RESULTS: We analyzed 531 patients with hypertrophic cardiomyopathy (age: 56±14 years...

  1. Poststroke Shoulder Pain in Turkish Stroke Patients: Relationship with Clinical Factors and Functional Outcomes

    Science.gov (United States)

    Barlak, Aysegul; Unsal, Sibel; Kaya, Kurtulus; Sahin-Onat, Sule; Ozel, Sumru

    2009-01-01

    The objective of this study was to assess the possible causes of hemiplegic shoulder pain (HSP) in Turkish patients with stroke, to identify the correlation between HSP and clinical factors, and to review the effects of HSP on functional outcomes. A total of 187 consecutive patients with stroke were evaluated for the presence of HSP and for the…

  2. Relationship between Helicobacter pylori virulence factors and regulatory cytokines as predictors of clinical outcome

    Science.gov (United States)

    Serrano, Carolina; Diaz, Maria Ines; Valdivia, Alejandra; Godoy, Alex; Peña, Alfredo; Rollan, Antonio; Kirberg, Arturo; Hebel, Eduardo; Fierro, Jaqueline; Klapp, Gerardo; Venegas, Alejandro; Harris, Paul R.

    2013-01-01

    H. pylori infection is highly prevalent in Chile (73%). Usually a minority of infected patients develops complications such as ulcers and gastric cancer that have been associated with the presence of virulence factors (cagA, vacA) and host T helper response (Th1/Th2). Our aim was to evaluate the relationship between strain virulence and host immune response, using a multiple regression approach for the development of a model based on data collected from H. pylori infected patients in Chile. We analyzed levels of selected cytokines determined by ELISA (IL-12, IL-10, IFN-γ and IL-4) and the presence of cagA and vacA alleles polymorphisms determined by PCR in antral biopsies of 41 patients referred to endoscopy. By multiple regression analysis we established a correlation between bacterial and host factors using clinical outcome (gastritis and duodenal ulcer) as dependent variables. The selected model was described by: clinical outcome = 0.867491 (cagA) + 0.0131847 (IL-12/IL-10) + 0.0103503 (IFN-γ/IL-4) and it was able to explain over 90% of clinical outcomes observations (R2=96.4). This model considers that clinical outcomes are better explained by the interaction of host immune factors and strain virulence as a complex and interdependent mechanism. PMID:17336120

  3. Body Composition in Relation to Clinical Outcomes in Renal Cell Cancer

    NARCIS (Netherlands)

    Vrieling, Alina; Kampman, Ellen; Knijnenburg, Nathalja C.; Mulders, Peter F.; Sedelaar, J.P.M.; Baracos, Vickie E.; Kiemeney, Lambertus A.

    2016-01-01

    Context: Several studies suggest that body composition (ie, body proportions of muscle and fat defined by computed tomography) is associated with clinical outcomes of several cancer types, including renal cell cancer (RCC). Objective: To conduct a systematic review and meta-analysis of the evidence

  4. Hand dermatitis: a review of clinical features, therapeutic options, and long-term outcomes.

    Science.gov (United States)

    Warshaw, Erin; Lee, Gina; Storrs, Francis J

    2003-09-01

    Hand dermatitis is a common skin condition that may be chronic, debilitating, and costly for patients, insurers, and employers. The epidemiology, clinical features, occupational issues, and long-term outcomes of hand dermatitis are summarized in this review. Therapeutic options are also discussed in detail, focusing on treatment of recalcitrant hand dermatitis.

  5. Median and ulnar nerve injuries: prognosis and predictors for clinical outcome

    NARCIS (Netherlands)

    J.B. Jaquet (Jean)

    2004-01-01

    textabstractIn chapter 1 the author provide a general introduction on median and ulnar nerve injuries. Furthermore the aims for this thesis, entitled median and ulnar nerve injuries: prognosis and predictors for clinical outcome, are defi ned. Chapter 2 comprises an investigation into the overall fu

  6. Virus and host factors affecting the clinical outcome of Bluetongue Virus infection

    NARCIS (Netherlands)

    Caporale, M.; Gialleonorado, L.; Janowicz, A.; Wilkie, G.; Shaw, A.; Savini, G.; Rijn, van P.A.; Mertens, P.; Ventura, M.; Palmarini, M.

    2014-01-01

    Bluetongue is a major infectious disease of ruminants caused by bluetongue virus (BTV), an arbovirus transmitted by Culicoides. Here, we assessed virus and host factors influencing the clinical outcome of BTV infection using a single experimental framework. We investigated how mammalian host species

  7. Meta-analysis of APOE genotype and subarachnoid hemorrhage - Clinical outcome and delayed ischemia

    NARCIS (Netherlands)

    Lanterna, L. A.; Ruigrok, Y.; Alexander, S.; Tang, J.; Biroli, F.; Dunn, L. T.; Poon, S.

    2007-01-01

    Background: Emerging evidence suggests that the APOE4 allele may increase the risk of a negative outcome in patients with aneurysmal subarachnoid hemorrhage (SAH), but the results are conflicting. A genetic variable predicting the individual clinical course is currently lacking. Objective: To examin

  8. Clinical Outcomes of Extreme Lateral Interbody Fusion in the Treatment of Adult Degenerative Scoliosis

    Directory of Open Access Journals (Sweden)

    Adam M. Caputo

    2012-01-01

    Full Text Available Introduction. The use of extreme lateral interbody fusion (XLIF and other lateral access surgery is rapidly increasing in popularity. However, limited data is available regarding its use in scoliosis surgery. The objective of this study was to evaluate the clinical outcomes of adults with degenerative lumbar scoliosis treated with XLIF. Methods. Thirty consecutive patients with adult degenerative scoliosis treated by a single surgeon at a major academic institution were followed for an average of 14.3 months. Interbody fusion was completed using the XLIF technique with supplemental posterior instrumentation. Validated clinical outcome scores were obtained on patients preoperatively and at most recent follow-up. Complications were recorded. Results. The study group demonstrated improvement in multiple clinical outcome scores. Oswestry Disability Index scores improved from 24.8 to 19.0 (P < 0.001. Short Form-12 scores improved, although the change was not significant. Visual analog scores for back pain decreased from 6.8 to 4.6 (P < 0.001 while scores for leg pain decreased from 5.4 to 2.8 (P < 0.001. A total of six minor complications (20% were recorded, and two patients (6.7% required additional surgery. Conclusions. Based on the significant improvement in validated clinical outcome scores, XLIF is effective in the treatment of adult degenerative scoliosis.

  9. Clinical Features and Outcome of Ebola Virus Disease in Pediatric Patients

    DEFF Research Database (Denmark)

    Damkjær, Mads; Rudolf, Frauke; Mishra, Sharmistha;

    2016-01-01

    Clinical and outcome data on pediatric Ebola virus disease are limited. We report a case-series of 33 pediatric patients with Ebola virus disease in a single Ebola Treatment Center in 2014-2015. The case-fatality rate was 42%, with the majority of deaths occurring within 10 days of admission....

  10. Oral mucositis and the clinical and economic outcomes of hematopoietic stem-cell transplantation

    NARCIS (Netherlands)

    Sonis, ST; Oster, G; Fuchs, H; Bellm, L; Bradford, WZ; Edelsberg, J; Hayden, [No Value; Eilers, J; Epstein, JB; LeVeque, FG; Miller, C; Peterson, DE; Schubert, MM; Spijkervet, FKL; Horowitz, M

    2001-01-01

    Purpose: To explore the relationship between oral mucositis and selected clinical and economic outcomes in blood and marrow transplant patients. Patients and Methods: Subjects consisted of 92 transplant patients from eight centers who participated in a multinational pilot study of a new oral mucosit

  11. The influence of neck thrombus on clinical outcome and aneurysm morphology after endovascular aneurysm repair

    NARCIS (Netherlands)

    F.M.V. Bastos Gonçalves (Frederico); H.J.M. Verhagen (Hence); K. Chinsakchai (Khamin); J.W. van Keulen (Jasper); M.T. Voûte (Michiel); H.J.A. Zandvoort (Herman); F.L. Moll (Frans); J.A. van Herwaarden (Joost)

    2012-01-01

    textabstractObjective: This study investigated the influence of significant aneurysm neck thrombus in clinical and morphologic outcomes after endovascular aneurysm repair (EVAR). Methods: The patient population was derived from a prospective EVAR database from two university institutions in The Neth

  12. Long-term Clinical Outcomes of Splanchnic Vein Thrombosis Results of an International Registry

    NARCIS (Netherlands)

    Ageno, Walter; Riva, Nicoletta; Schulman, Sam; Beyer-Westendorf, Jan; Bang, Soo Mee; Senzolo, Marco; Grandone, Elvira; Pasca, Samantha; Di Minno, Matteo Nicola Dario; Duce, Rita; Malato, Alessandra; Santoro, Rita; Poli, Daniela; Verhamme, Peter; Martinelli, Ida; Kamphuisen, Pieter; Oh, Doyeun; D'Amico, Elbio; Becattini, Cecilia; De Stefano, Valerio; Vidili, Gianpaolo; Vaccarino, Antonella; Nardo, Barbara; Di Nisio, Marcello; Dentali, Francesco

    2015-01-01

    IMPORTANCE Little information is available on the long-term clinical outcome of patients with splanchnic vein thrombosis (SVT). OBJECTIVE To assess the incidence rates of bleeding, thrombotic events, and mortality in a large international cohort of patients with SVT. DESIGN, SETTING, AND PARTICIPANT

  13. Obesity Is Common in Axial Spondyloarthritis and Is Associated with Poor Clinical Outcome

    NARCIS (Netherlands)

    Maas, Fiona; Arends, Suzanne; van der Veer, Eveline; Wink, Freke; Efde, Monique; Bootsma, Hendrika; Brouwer, Elisabeth; Spoorenberg, Anneke

    2016-01-01

    Objective. To assess the prevalence of overweight and obesity in a large cohort of patients with axial spondyloarthritis (axSpA) in comparison with the general population. To explore the relationship of body mass index (BMI) with clinical outcome in axSpA. Methods. Patients from the Groningen Leeuwa

  14. Clinical Features and Outcome of Patients With IRAK-4 and MyD88 Deficiency

    NARCIS (Netherlands)

    Picard, Capucine; von Bernuth, Horst; Ghandil, Pegah; Chrabieh, Maya; Levy, Ofer; Arkwright, Peter D.; McDonald, Douglas; Geha, Raif S.; Takada, Hidetoshi; Krause, Jens C.; Creech, C. Buddy; Ku, Cheng-Lung; Ehl, Stephan; Marodi, Laszlo; Al-Muhsen, Saleh; Al-Hajjar, Sami; Al-Ghonaium, Abdulaziz; Day-Good, Noorbibi K.; Holland, Steven M.; Gallin, John I.; Chapel, Helen; Speert, David P.; Rodriguez-Gallego, Carlos; Colino, Elena; Garty, Ben-Zion; Roifman, Chaim; Hara, Toshiro; Yoshikawa, Hideto; Nonoyama, Shigeaki; Domachowske, Joseph; Issekutz, Andrew C.; Tang, Mimi; Smart, Joanne; Zitnik, Simona Eva; Hoarau, Cyrille; Kumararatne, Dinakantha S.; Thrasher, Adrian J.; Davies, E. Graham; Bethune, Claire; Sirvent, Nicolas; de Ricaud, Dominique; Camcioglu, Yildiz; Vasconcelos, Julia; Guedes, Margarida; Vitor, Artur Bonito; Rodrigo, Carlos; Almazan, Francisco; Mendez, Maria; Ignacio Arostegui, Juan; Alsina, Laia; Fortuny, Claudia; Reichenbach, Janine; Verbsky, James W.; Bossuyt, Xavier; Doffinger, Rainer; Abel, Laurent; Puel, Anne; Casanova, Jean-Laurent

    2010-01-01

    Autosomal recessive interleukin-1 receptor-associated kinase (IRAK)-4 and myeloid differentiation factor (MyD) 88 deficiencies impair Toll-like receptor (TLR)-and interleukin-1 receptor-mediated immunity. We documented the clinical features and outcome of 48 patients with IRAK-4 deficiency and 12 pa

  15. Clinical outcomes after cell-seeded autologous chondrocyte implantation of the knee

    DEFF Research Database (Denmark)

    Pestka, Jan M; Bode, Gerrit; Salzmann, Gian;

    2014-01-01

    BACKGROUND: Autologous chondrocyte implantation (ACI) has been associated with satisfying results. Still, it remains unclear when success or failure after ACI can be estimated. PURPOSE: To evaluate the clinical outcomes of cell-seeded collagen matrix-supported ACI (ACI-Cs) for the treatment of ca...

  16. Data Mining Session-Based Patient Reported Outcomes (PROs) in a Mental Health Setting: Toward Data-Driven Clinical Decision Support and Personalized Treatment

    CERN Document Server

    Bennett, Casey; Bragg, April; Luellen, Jason; Van Regenmorter, Christina; Lockman, Jennifer; Reiserer, Randall; 10.1109/HISB.2011.20

    2011-01-01

    The CDOI outcome measure - a patient-reported outcome (PRO) instrument utilizing direct client feedback - was implemented in a large, real-world behavioral healthcare setting in order to evaluate previous findings from smaller controlled studies. PROs provide an alternative window into treatment effectiveness based on client perception and facilitate detection of problems/symptoms for which there is no discernible measure (e.g. pain). The principal focus of the study was to evaluate the utility of the CDOI for predictive modeling of outcomes in a live clinical setting. Implementation factors were also addressed within the framework of the Theory of Planned Behavior by linking adoption rates to implementation practices and clinician perceptions. The results showed that the CDOI does contain significant capacity to predict outcome delta over time based on baseline and early change scores in a large, real-world clinical setting, as suggested in previous research. The implementation analysis revealed a number of ...

  17. Detection and measurement of clinically meaningful visual field progression in clinical trials for glaucoma.

    Science.gov (United States)

    De Moraes, C Gustavo; Liebmann, Jeffrey M; Levin, Leonard A

    2017-01-01

    Glaucomatous visual field progression has both personal and societal costs and therefore has a serious impact on quality of life. At the present time, intraocular pressure (IOP) is considered to be the most important modifiable risk factor for glaucoma onset and progression. Reduction of IOP has been repeatedly demonstrated to be an effective intervention across the spectrum of glaucoma, regardless of subtype or disease stage. In the setting of approval of IOP-lowering therapies, it is expected that effects on IOP will translate into benefits in long-term patient-reported outcomes. Nonetheless, the effect of these medications on IOP and their associated risks can be consistently and objectively measured. This helps to explain why regulatory approval of new therapies in glaucoma has historically used IOP as the outcome variable. Although all approved treatments for glaucoma involve IOP reduction, patients frequently continue to progress despite treatment. It would therefore be beneficial to develop treatments that preserve visual function through mechanisms other than lowering IOP. The United States Food and Drug Administration (FDA) has stated that they will accept a clinically meaningful definition of visual field progression using Glaucoma Change Probability criteria. Nonetheless, these criteria do not take into account the time (and hence, the speed) needed to reach significant change. In this paper we provide an analysis based on the existing literature to support the hypothesis that decreasing the rate of visual field progression by 30% in a trial lasting 12-18 months is clinically meaningful. We demonstrate that a 30% decrease in rate of visual field progression can be reliably projected to have a significant effect on health-related quality of life, as defined by validated instruments designed to measure that endpoint.

  18. The Outcomes of Gestational Diabetes Mellitus after a Telecare Approach Are Not Inferior to Traditional Outpatient Clinic Visits

    Directory of Open Access Journals (Sweden)

    Laura del Valle

    2010-01-01

    Full Text Available Objective. To evaluate the feasibility of a telemedicine system based on Internet and a short message service in pregnancy and its influence on delivery and neonatal outcomes of women with gestational diabetes mellitus (GDM. Methods. 100 women diagnosed of GDM were randomized into two parallel groups, a control group based on traditional face-to-face outpatient clinic visits and an intervention group, which was provided with a Telemedicine system for the transmission of capillary glucose data and short text messages with weekly professional feedback. 97 women completed the study (48/49, resp.. Main Outcomes Measured. The percentage of women achieving HbA1c values <5.8%, normal vaginal delivery and having a large for-gestational-age newborn were evaluated. Results. Despite a significant reduction in outpatient clinic visits in the experimental group, particularly in insulin-treated women (2.4 versus 4.6 hours per insulin-treated woman resp.; P<.001, no significant differences were found between the experimental and traditional groups regarding HbA1c levels (all women had HbA1c <5.8% during pregnancy, normal vaginal delivery (40.8% versus 54.2%, resp.; P>.05 and large-for-gestational-age newborns (6.1% versus 8.3%, resp.; P>.05. Conclusions. The system significantly reduces the need for outpatient clinic visits and achieves similar pregnancy, delivery, and newborn outcomes.

  19. Clinical Outcomes Following the Latarjet Procedure in Contact and Collision Athletes

    Science.gov (United States)

    Privitera, David M.; Siegel, Elana J.; Higgins, Laurence D.

    2014-01-01

    Objectives: Although there are several reports of clinical outcomes after the Latarjet procedure for recurrent anterior glenohumeral instability, the literature is sparse for these Latarjet outcomes in the strictly contact or collision-type sport athletes who have significant glenoid deficiency and/or failed previous stabilization surgery. The purpose of this study was to evaluate the clinical and functional results of these contact or collision athletes who underwent a Latarjet for symptomatic instability with glenoid bone loss or failed stabilization surgery, using modern instability outcome measures. Study Design: Case series, Level of evidence, 4. Methods: Sixty-one consecutive contact and/or collision athletes (64 shoulders) treated with an open Latarjet procedure for recurrent anterior glenohumeral instability with significant glenoid bony deficiency and/or failed prior stabilization were retrospectively identified from two surgeons’ practices. Thirty-nine patients and 42 shoulders (66%) were evaluated at a mean follow-up of 46 months (range: 24-95), whose an average age of surgery of 25.9 years (range: 16-47). Primary outcome measures were the Western Ontario Shoulder Instability Index (WOSI), American Shoulder and Elbow Society Questionnaire (ASES), Visual Analogue Scale, and return to sporting activity. IRB approval was granted for this study. Results: Thirty-seven of forty-two shoulders (88%) were perceived as stable to these athletes. Two patients experienced subluxation events at 18 and 24 months after their Latarjet procedures. These 2 patients underwent further surgery including an arthroscopic debridement with biceps tenodesis and the other a revision stabilization Eden-Hybinette procedure, performed at 22 and 29 months after their Latarjets, respectively. One additional patient underwent surgery for hardware removal with arthroscopic debridement, with no reports of concomitant instability. Average WOSI and ASES scores for 42 shoulders were 76

  20. A Conceptual Framework for Measuring Clinical Problem-Solving

    Science.gov (United States)

    Bashook, Philip G.

    1976-01-01

    Presents a 3-dimensional conceptual framework for measuring clinical competence: problem-solving process, clinical discipline, and context of care. The intersection of the dimensions defines the clinical practice domain to be measured. For each domain specific problems can be identified and clinicians asked to demonstrate competence in resolving…

  1. The feasibility of using electronic clinical outcome assessments in people with schizophrenia and their informal caregivers

    Directory of Open Access Journals (Sweden)

    Tolley C

    2015-03-01

    Full Text Available Chloe Tolley,1 Diana Rofail,2 Adam Gater,1 Justine K Lalonde31Adelphi Values Ltd, Bollington, UK; 2Roche Products Ltd, Welwyn Garden City, UK; 3Roche S.A.S, Paris, France Abstract: Many clinical outcome assessments (COAs were originally developed for completion via pen and paper. However, in recent years there have been movements toward electronic capture of such data in an effort to reduce missing data, provide time-stamped records, minimize administrative burden, and avoid secondary data entry errors. Although established in many patient populations, the implications of using electronic COAs in schizophrenia are unknown. In accordance with International Society for Pharmacoeconomics and Outcomes Research (ISPOR Task Force recommendations, in-depth cognitive debriefing and usability interviews were conducted with people with schizophrenia (n=12, their informal (unpaid caregivers (n=12, and research support staff (n=6 to assess the suitability of administration of various electronic COA measures using an electronic tablet device. Minimal issues were encountered by participants when completing or administering the COAs in electronic format, with many finding it easier to complete instruments in this mode than by pen and paper. The majority of issues reported were specific to the device functionality rather than the electronic mode of administration. Findings support data collection via electronic tablet in people with schizophrenia and their caregivers. The appropriateness of other forms of electronic data capture (eg, smartphones, interactive voice response systems, etc is a topic for future investigation. Keywords: ePRO, eCOA, mode of administration, electronic data capture, usability 

  2. Clinical outcomes of toe amputation in patients with type 2 diabetes in Tianjin, China.

    Science.gov (United States)

    Chu, Yue-Jie; Li, Xi-Wen; Wang, Peng-Hua; Xu, Jun; Sun, Hao-Jie; Ding, Min; Jiao, Jiao; Ji, Xiao-Yan; Feng, Shu-hong

    2016-04-01

    The aim of this study is to determine the predictors for reulceration, reamputation and mortality in patients with diabetes following toe amputation, and the impact of activities of daily living on clinical outcomes. This prospective cohort study included 245 patients who had undergone toe amputation (202 healing and 43 non-healing) and was followed for a 5-year period. Data regarding new foot ulceration, reamputation and mortality were recorded, and the patients' activities of daily living were evaluated. The rate of wound healing was 82·4%. The rate of follow-up in the healed group was 91·6%. In years 1, 3 and 5, the cumulative incidence of patients who developed a new foot ulcer was 27·3%, 57·2% and 76·4%, respectively, leading to reamputation in 12·5%, 22·3% and 47·1%, respectively. The cumulative mortality was 5·8%, 15·1% and 32·7% at 1, 3 and 5 years, respectively. Multivariate analysis showed that GHbA1c > 9% (75 mmol/mol) was identified as an independent predictor of impaired wound healing, reulceration and reamputation. An age of >70 years was identified as an independent predictor of reamputation, mortality and impairment of activities of daily living. Despite a satisfactory initial healing rate after the first toe amputation, with the extension course after the toe amputation, the long-term outcomes are not optimistic. In developing countries like China, taking measures to prevent reulceration and reamputation is very important for patients with diabetic foot minor amputations, especially following toe amputation.

  3. Relationship Between Severity Classification of Acute Exacerbation of Chronic Obstructive Pulmonary Disease and Clinical Outcomes in Hospitalized Patients

    Science.gov (United States)

    Sanjuán, Pilar; Huerta, Arturo; Nieto-Codesido, Irene; Ferreira-Gonzalez, Lucía; Sibila, Oriol; Restrepo, Marcos I

    2017-01-01

    Background Limited data are available regarding the impact of the potential validation of the Canadian Thoracic Society (CTS) guidelines recommendations in classifying patients with an acute exacerbation of chronic obstructive pulmonary disease (AECOPD) in simple and complex. The aim of the present study was to assess the CTS recommendations regarding risk stratification on clinical outcomes among patients hospitalized with an AECOPD. Methods We developed a retrospective cohort study of patients admitted to one tertiary hospital with a diagnosis of AECOPD. The main clinical outcome was the percentage of treatment failure. Secondary outcomes were 30-day, 90-day, and 1-year readmission and mortality rate, length of stay in hospital, intensive care unit (ICU) admission rate, time to readmission, and time to death. Multivariate analyses were performed using 1-year mortality rate as the dependent measures. Results One hundred forty-three patients composed the final study population, most of them (106 [74.1%)] classified as complex acute exacerbation (C-AE) of COPD. C-AE patients had similar rate of treatment failure compared with simple acute exacerbation (S-AE) of COPD (31.1% vs. 27%; p = 0.63). There were no differences regarding the length of stay in hospital, ICU admission rate, and 30-day, 90-day, and 1-year readmission rate. C-AE patients had faster declined measures on time to death (691.6 ± 430 days vs. 998.1 ± 355 days; p = 0.02). In the multivariate analysis, after adjusting for comorbidity, lung function and previous treatment, C-AE patients had a significant higher mortality at one year (Odds Ratio [OR] = 4.9 (Confidence Interval [CI] 95%: 1.16-21); p = 0.031). Conclusions In hospitalized patients with an AECOPD, CTS classification, according to the presence of risk factors, was not associated with worse short-term clinical outcomes although it is related with long-term mortality. 

  4. Neighbourhood social capital: measurement issues and associations with health outcomes.

    Science.gov (United States)

    Mackenbach, J D; Lakerveld, J; van Lenthe, F J; Kawachi, I; McKee, M; Rutter, H; Glonti, K; Compernolle, S; De Bourdeaudhuij, I; Feuillet, T; Oppert, J-M; Nijpels, G; Brug, J

    2016-01-01

    We compared ecometric neighbourhood scores of social capital (contextual variation) to mean neighbourhood scores (individual and contextual variation), using several health-related outcomes (i.e. self-rated health, weight status and obesity-related behaviours). Data were analysed from 5,900 participants in the European SPOTLIGHT survey. Factor analysis of the 13-item social capital scale revealed two social capital constructs: social networks and social cohesion. The associations of ecometric and mean neighbourhood-level scores of these constructs with self-rated health, weight status and obesity-related behaviours were analysed using multilevel regression analyses, adjusted for key covariates. Analyses using ecometric and mean neighbourhood scores, but not mean neighbourhood scores adjusted for individual scores, yielded similar regression coefficients. Higher levels of social network and social cohesion were not only associated with better self-rated health, lower odds of obesity and higher fruit consumption, but also with prolonged sitting and less transport-related physical activity. Only associations with transport-related physical activity and sedentary behaviours were associated with mean neighbourhood scores adjusted for individual scores. As analyses using ecometric scores generated the same results as using mean neighbourhood scores, but different results when using mean neighbourhood scores adjusted for individual scores, this suggests that the theoretical advantage of the ecometric approach (i.e. teasing out individual and contextual variation) may not be achieved in practice. The different operationalisations of social network and social cohesion were associated with several health outcomes, but the constructs that appeared to represent the contextual variation best were only associated with two of the outcomes.

  5. Neonatal outcomes in women with gestational diabetes mellitus treated with metformin in compare with insulin: A randomized clinical trial

    Directory of Open Access Journals (Sweden)

    Safura Ruholamin

    2014-01-01

    Full Text Available Background: The objective of this study was to compare neonatal outcomes in women with gestational diabetes mellitus (GDM treated with either metformin or insulin. Materials and Methods: A randomized clinical trial carried out on year 2011 on 109 women with GDM who did not adequately control by dietary measures. They received metformin 500 mg once or twice daily or insulin 0.2 IU/kg/day initially. The dose was titrated to achieve target blood glucose values. Neonatal outcomes such as hypoglycemia, birth weight, Apgar score, umbilical artery pH, and hyperbilirubinemia in the 50 women who remained exclusively on metformin were compared with 50 women who treated with insulin. Results: Two groups were similar in mean fasting blood sugar (P = 0.7 and postprandial measurements (P = 0.8 throughout GDM treatment. Pregnancy complications or preterm labor were not different significantly between two groups. Considering neonatal outcomes between insulin and metformin groups, such as hypoglycemia (2 [4%] and 0 [0%], respectively, birth weight (3342 ± 506 mg and 3176 ± 438 mg, respectively, 5 th min Apgar score <7 (no one in either group, umbilical artery pH <7.05 (no one in either group and hyperbilirubinemia (1 [2%] and 0 [0%], respectively, no significant statistical differences were seen. Conclusion: Based on these preliminary data, considering neonatal outcomes, metformin appears to be a safe as insulin in the treatment of GDM.

  6. Is There an Association Between the “Critical Shoulder Angle” and Clinical Outcome after Rotator Cuff Repair?

    Science.gov (United States)

    Kirsch, Jacob Matthew; Nathani, Amit; Robbins, Christopher; Gagnier, Joel Joseph; Bedi, Asheesh; Miller, Bruce S.

    2016-01-01

    Objectives: Variations in scapular morphology have been associated with the development of atraumatic rotator cuff tears (RCT). Current theories suggest a morphologic predisposition for altered shoulder biomechanics favoring the development of RCTs. The critical shoulder angle (CSA) is a radiographic measure that accounts for both glenoid inclination and lateral extension of the acromion, and angles >35 degrees are reported to be correlated with the development of degenerative RCTs. The impact of the CSA on outcomes following rotator cuff repair (RCR) has not previously been investigated. The purpose of this study was to investigate the relationship between the CSA and clinical outcomes after rotator cuff repair. Methods: As part of a prospective observational cohort study we obtained CSA measurements for 144 patients with documented full-thickness RCTs who were followed up for a minimum of 48 weeks. Patients were then stratified based on RCT etiology and treatment. Demographic data as well as The Western Ontario Rotator Cuff Index (WORC), American Shoulder and Elbow Surgeons (ASES) score and Visual Analog Scale (VAS) for pain were collected at baseline, four, eight, 16, 32 and 48 weeks. The CSA for all of the patients was measured retrospectively, with all assessors being blinded to the data and we calculated interclass correlation coefficients (ICC) to measure agreement. The statistical analysis included longitudinal multilevel regression modeling to investigate the association of the CSA and the WORC, ASES and VAS for pain. Results: Controlling for demographic and clinical characteristics, patients with CSAs less than 38 degrees reported better outcome scores over time compared to those with CSAs greater than 38 degrees (WORC: B=-106.6, p=0.025, ASES: B=4.83, p=0.0001, VAS: B=-12.99, p=0.0001). Interobserver and intraobserver reliability for CSA measurements resulted in an ICC of 0.969 and 0.982 respectively, indicating excellent agreement. Conclusion: We found

  7. Patient outcomes after initiation of Sabbath closure of a methadone maintenance clinic in Israel.

    Science.gov (United States)

    Gelkopf, M; Bleich, A; Hayward, R; Adelson, M

    1998-11-01

    The study examined whether closing of a methadone maintenance clinic in Israel on the Sabbath was associated with adverse patient outcomes. One take-home dose of methadone was given to all patients for that day regardless of whether they had earned take-home privileges. No difference was found in dropout rates for the six-month periods before and after Saturday closure was initiated. Results of random, twice-weekly urinalyses for all patients did not indicate increased use of heroin. The findings suggest that closure of a methadone clinic at least one day a week does not jeopardize patient outcome. Cutting hours of operation would reduce workload and enable clinics to function more economically.

  8. Neurological outcome scale for traumatic brain injury: III. Criterion-related validity and sensitivity to change in the NABIS hypothermia-II clinical trial.

    Science.gov (United States)

    McCauley, Stephen R; Wilde, Elisabeth A; Moretti, Paolo; Macleod, Marianne C; Pedroza, Claudia; Drever, Pamala; Fourwinds, Sierra; Frisby, Melisa L; Beers, Sue R; Scott, James N; Hunter, Jill V; Traipe, Elfrides; Valadka, Alex B; Okonkwo, David O; Zygun, David A; Puccio, Ava M; Clifton, Guy L

    2013-09-01

    The neurological outcome scale for traumatic brain injury (NOS-TBI) is a measure assessing neurological functioning in patients with TBI. We hypothesized that the NOS-TBI would exhibit adequate concurrent and predictive validity and demonstrate more sensitivity to change, compared with other well-established outcome measures. We analyzed data from the National Acute Brain Injury Study: Hypothermia-II clinical trial. Participants were 16-45 years of age with severe TBI assessed at 1, 3, 6, and 12 months postinjury. For analysis of criterion-related validity (concurrent and predictive), Spearman's rank-order correlations were calculated between the NOS-TBI and the glasgow outcome scale (GOS), GOS-extended (GOS-E), disability rating scale (DRS), and neurobehavioral rating scale-revised (NRS-R). Concurrent validity was demonstrated through significant correlations between the NOS-TBI and GOS, GOS-E, DRS, and NRS-R measured contemporaneously at 3, 6, and 12 months postinjury (all prate was outcome in the GOS, GOS-E, and DRS at 3 and 6 months postinjury (all poutcomes at 6 and 12 months postinjury (all poutcome measures. The NOS-TBI may enhance prediction of outcome in clinical practice and measurement of outcome in TBI research.

  9. Prospective evaluation of outcome measures in free-flap surgery.

    LENUS (Irish Health Repository)

    Kelly, John L

    2004-08-01

    Free-flap failure is usually caused by venous or arterial thrombosis. In many cases, lack of experience and surgical delay also contribute to flap loss. The authors prospectively analyzed the outcome of 57 free flaps over a 28-month period (January, 1999 to April, 2001). The setting was a university hospital tertiary referral center. Anastomotic technique, ischemia time, choice of anticoagulant, and the grade of surgeon were recorded. The type of flap, medications, and co-morbidities, including preoperative radiotherapy, were also documented. Ten flaps were re-explored (17 percent). There were four cases of complete flap failure (6.7 percent) and five cases of partial failure (8.5 percent). In patients who received perioperative systemic heparin or dextran, there was no evidence of flap failure (p = .08). The mean ischemia time was similar in flaps that failed (95 +\\/- 29 min) and in those that survived (92 +\\/- 34 min). Also, the number of anastomoses performed by trainees in flaps that failed (22 percent), was similar to the number in flaps that survived (28 percent). Nine patients received preoperative radiotherapy, and there was complete flap survival in each case. This study reveals that closely supervised anastomoses performed by trainees may have a similar outcome to those performed by more senior surgeons. There was no adverse effect from radiotherapy or increased ischemia time on flap survival.

  10. Outcome measures for primary Sjogren's syndrome : A comprehensive review

    NARCIS (Netherlands)

    Seror, Raphaele; Theander, Elke; Bootsma, Hendrika; Bowman, Simon J.; Tzioufas, Athanasios; Gottenberg, Jacques-Eric; Ramos-Casals, Manel; Doerner, Thomas; Ravaud, Philippe; Mariette, Xavier; Vitali, Claudio

    2014-01-01

    Lymphocytic infiltration of different exocrine and non-exocrine epithelia is the pathological hallmark of primary Sjogren's syndrome, whereas involvement of salivary and lachrymal glands with the clinical counterpart of dry eye and dry mouth are the predominant features of the disease, together with

  11. Correlation between classification in risk categories and clinical aspects and outcomes 1

    Science.gov (United States)

    Oliveira, Gabriella Novelli; Vancini-Campanharo, Cássia Regina; Lopes, Maria Carolina Barbosa Teixeira; Barbosa, Dulce Aparecida; Okuno, Meiry Fernanda Pinto; Batista, Ruth Ester Assayag

    2016-01-01

    ABSTRACT Objective: to correlate classification in risk categories with the clinical profiles, outcomes and origins of patients. Method: analytical cross-sectional study conducted with 697 medical forms of adult patients. The variables included: age, sex, origin, signs and symptoms, exams, personal antecedents, classification in risk categories, medical specialties, and outcome. The Chi-square and likelihood ratio tests were used to associate classifications in risk categories with origin, signs and symptoms, exams, personal antecedents, medical specialty, and outcome. Results: most patients were women with an average age of 44.5 years. Pain and dyspnea were the symptoms most frequently reported while hypertension and diabetes mellitus were the most common comorbidities. Classifications in the green and yellow categories were the most frequent and hospital discharge the most common outcome. Patients classified in the red category presented the highest percentage of ambulance origin due to surgical reasons. Those classified in the orange and red categories also presented the highest percentage of hospitalization and death. Conclusion: correlation between clinical aspects and outcomes indicate there is a relationship between the complexity of components in the categories with greater severity, evidenced by the highest percentage of hospitalization and death. PMID:27982310

  12. Comparative effectiveness studies to improve clinical outcomes in end stage renal disease: the DEcIDE patient outcomes in end stage renal disease study

    Directory of Open Access Journals (Sweden)

    Boulware Ebony L

    2012-12-01

    Full Text Available Abstract Background Evidence is lacking to inform providers’ and patients’ decisions about many common treatment strategies for patients with end stage renal disease (ESRD. Methods/design The DEcIDE Patient Outcomes in ESRD Study is funded by the United States (US Agency for Health Care Research and Quality to study the comparative effectiveness of: 1 antihypertensive therapies, 2 early versus later initiation of dialysis, and 3 intravenous iron therapies on clinical outcomes in patients with ESRD. Ongoing studies utilize four existing, nationally representative cohorts of patients with ESRD, including (1 the Choices for Healthy Outcomes in Caring for ESRD study (1041 incident dialysis patients recruited from October 1995 to June 1999 with complete outcome ascertainment through 2009, (2 the Dialysis Clinic Inc (45,124 incident dialysis patients initiating and receiving their care from 2003–2010 with complete outcome ascertainment through 2010, (3 the United States Renal Data System (333,308 incident dialysis patients from 2006–2009 with complete outcome ascertainment through 2010, and (4 the Cleveland Clinic Foundation Chronic Kidney Disease Registry (53,399 patients with chronic kidney disease with outcome ascertainment from 2005 through 2009. We ascertain patient reported outcomes (i.e., health-related quality of life, morbidity, and mortality using clinical and administrative data, and data obtained from national death indices. We use advanced statistical methods (e.g., propensity scoring and marginal structural modeling to account for potential biases of our study designs. All data are de-identified for analyses. The conduct of studies and dissemination of findings are guided by input from Stakeholders in the ESRD community. Discussion The DEcIDE Patient Outcomes in ESRD Study will provide needed evidence regarding the effectiveness of common treatments employed for dialysis patients. Carefully planned dissemination strategies to the

  13. Sagittal and Frontal Plane Evaluation of the Whole Spine and Clinical Outcomes after Vertebral Fractures

    Directory of Open Access Journals (Sweden)

    A. Topalidou

    2015-01-01

    Full Text Available Although it is known that a change in any level of the spine alters biomechanics, there are not many studies to evaluate the spine as a whole in both sagittal and frontal planes. This prospective cohort study evaluates the morphology and mobility of the entire spine in patients with vertebral fractures. The Treatment Group consisted of 43 patients who underwent percutaneous balloon kyphoplasty or percutaneous balloon kyphoplasty plus fixation. The Control Group consisted of 39 healthy subjects. Spinal Mouse was used for the assessment of the curvatures and the mobility of the spine. Clinical outcomes were evaluated by Visual Analogue Scale and Oswestry Disability Index. The measurements were recorded at 15 days and 3, 6, and 12 months postoperatively. Regarding the curvatures and mobility in sagittal plane, a statistically significant increase appeared early at 3 months, for lumbar curve, spinopelvic angulation, and overall trunk inclination. In the frontal plane, most of the improvements were recorded after 6 months. Patients with osteoporotic fracture showed statistically significant lower mean value than patients with traumatic fracture. Pain and disability index showed early improvements. This study provides a comprehensive and complete picture of the functionality of the spine in patients treated with percutaneous balloon kyphoplasty.

  14. Prediction of the potential clinical outcomes for post-resuscitated patients after cardiac arrest

    Science.gov (United States)

    Hong, Sungmin; Kwon, Bojun; Yun, Il Dong; Lee, Sang Uk; Kim, Kyuseok; Kim, Joonghee

    2013-02-01

    Cerebral injuries after cardiac arrest are serious causes for morbidity. Many previous researches in the medical society have been proposed to prognosticate the functional recoveries of post-resuscitated patients after cardiac arrest, but the validity of suggested features and the automation of prognostication have not been made yet. This paper presents the automatic classification method which predicts the potential clinical outcomes of post-resuscitated patients who suffered from cardiac arrest. The global features and the local features are adapted from the researches from the medical society. The global features, which are consisted of the percentage of the partial volume under the uniformly increasing thresholds, represent the global tendency of apparent diffusion coefficient value in a DWI. The local features are localized and measured on the refined local apparent diffusion coefficient minimal points. The local features represent the ischemic change of small areas in a brain. The features are trained and classified by the random forest method, which have been widely used in the machine learning society for classification. The validity of features is automatically evaluated during the classification process. The proposed method achieved the 0.129 false-positive rate while maintaining the perfect true-positive rate. The area-under-curve of the proposed method was 0.9516, which showed the feasibility and the robustness of the proposed method.

  15. Therapeutic trials in lupus nephritis. Problems related to renal histology, monitoring of therapy and measures of outcome.

    Science.gov (United States)

    Balow, J E

    1981-01-01

    Approaches to treatment of lupus nephritis have been complicated by controversies in the definitions of the types of renal histology, the relevance of immunological and renal monitoring techniques as therapeutic guidelines, and lack of definitive clinical trials. It is suggested that demonstration of the efficacy of various therapeutic agents in clinical trials may be identified earlier by renal histological changes and/or assessment of drug toxicity compared to the time required for differences based on renal functional changes to emerge as ultimate measures of outcome.

  16. Relationship between drug interactions and drug-related negative clinical outcomes in two community pharmacies

    Directory of Open Access Journals (Sweden)

    Gonzalo M

    2009-03-01

    Full Text Available Drug interactions may represent an iatrogenic risk that should be controlled in community pharmacies at the dispensing level. Aim: We analyzed the association between potential drug-drug interactions (DDIs and negative clinical outcomes.Methods: We used dispensing data from two community pharmacies: instances where drug dispensing was associated with a potential DDI and a comparison group of randomized dispensing operations with no potential DDI. In cases where potential DDIs were detected, we analyzed the underlying negative clinical outcomes. Age and gender data were included in the analysis.Results: During the study period, we registered 417 potential DDIs. The proportion of women and age were higher in the study group than in the comparison group. The average potential DDIs per patient was 1.31 (SD=0.72. The Consejo General de Colegios Oficiales de Farmacéuticos (CGCOF database did not produce an alert in 2.4% of the cases. Over-the-counter medication use was observed in 5% of the potential DDI cases. The drugs most frequently involved in potential DDIs were acenocoumarol, calcium salts, hydrochlorothiazide, and alendronic acid, whereas the most predominant potential DDIs were calcium salts and bisphosphonates, oral antidiabetics and thiazide diuretics, antidiabetics and glucose, and oral anticoagulant and paracetamol. The existence of a drug-related negative clinical outcome was observed only in 0.96% of the potential DDI cases (50% safety cases and 50% effectiveness cases. Conclusions: Only a small proportion of the detected potential DDIs lead to medication negative outcomes. Considering the drug-related negative clinical outcomes encountered, tighter control would be recommended in potential DDIs with NSAIDs or benzodiazepines.

  17. Modeling strategy to identify patients with primary immunodeficiency utilizing risk management and outcome measurement.

    Science.gov (United States)

    Modell, Vicki; Quinn, Jessica; Ginsberg, Grant; Gladue, Ron; Orange, Jordan; Modell, Fred

    2017-02-21

    This study seeks to generate analytic insights into risk management and probability of an identifiable primary immunodeficiency defect. The Jeffrey Modell Centers Network database, Jeffrey Modell Foundation's 10 Warning Signs, the 4 Stages of Testing Algorithm, physician-reported clinical outcomes, programs of physician education and public awareness, the SPIRIT® Analyzer, and newborn screening, taken together, generates P values of less than 0.05%. This indicates that the data results do not occur by chance, and that there is a better than 95% probability that the data are valid. The objectives are to improve patients' quality of life, while generating significant reduction of costs. The advances of the world's experts aligned with these JMF programs can generate analytic insights as to risk management and probability of an identifiable primary immunodeficiency defect. This strategy reduces the uncertainties related to primary immunodeficiency risks, as we can screen, test, identify, and treat undiagnosed patients. We can also address regional differences and prevalence, age, gender, treatment modalities, and sites of care, as well as economic benefits. These tools support high net benefits, substantial financial savings, and significant reduction of costs. All stakeholders, including patients, clinicians, pharmaceutical companies, third party payers, and government healthcare agencies, must address the earliest possible precise diagnosis, appropriate intervention and treatment, as well as stringent control of healthcare costs through risk assessment and outcome measurement. An affected patient is entitled to nothing less, and stakeholders are responsible to utilize tools currently available. Implementation offers a significant challenge to the entire primary immunodeficiency community.

  18. Patient reported outcome measures of quality of end-of-life care: A systematic review.

    Science.gov (United States)

    Kearns, Tara; Cornally, Nicola; Molloy, William

    2017-02-01

    End-of-life (EoL) care(1) is increasingly used as a generic term in preference to palliative care or terminal care, particularly with reference to individuals with chronic disease, who are resident in community and long-term care (LTC) settings. This review evaluates studies based on patient reported outcome measures (PROMS) of quality of EoL care across all health-care settings. From 1041 citations, 12 studies were extracted by searches conducted in EBSCO, Scopus, Web of Science, PubMed, Cochrane, Open Grey and Google Scholar databases. At present, the evidence base for EoL care is founded on cancer care. This review highlights the paucity of studies that evaluate quality of EoL care for patients with chronic disease outside the established cancer-acute care paradigm, particularly in LTC. This review highlights the absence of any PROMs for the estimated 60% of patients in LTC with cognitive impairment. Patient-reported outcomes (PROs) are critical to understanding how EoL care services and practices affect patients' health and EoL experience. PROMs describe the quality of care from the patient's perspective and add balance to existing clinical or proxy-derived knowledge on the quality of care and services provided.

  19. Perceived Benefits of Pre-Clinical Simulation-based Training on Clinical Learning Outcomes among Omani Undergraduate Nursing Students

    Directory of Open Access Journals (Sweden)

    Girija Madhavanprabhakaran

    2015-01-01

    Full Text Available Objectives: This study aimed to explore the benefits perceived by Omani undergraduate maternity nursing students regarding the effect of pre-clinical simulation-based training (PSBT on clinical learning outcomes. Methods: This non-experimental quantitative survey was conducted between August and December 2012 among third-year baccalaureate nursing students at Sultan Qaboos University in Muscat, Oman. Voluntary participants were exposed to faculty-guided PSBT sessions using low- and medium-fidelity manikins, standardised scenarios and skill checklists on antenatal, intranatal, postnatal and newborn care and assessment. Participants answered a purposely designed self-administered questionnaire on the benefits of PSBT in enhancing learning outcomes. Items were categorised into six subscales: knowledge, skills, patient safety, academic safety, confidence and satisfaction. Scores were rated on a four-point Likert scale. Results: Of the 57 participants, the majority (95.2% agreed that PSBT enhanced their knowledge. Most students (94.3% felt that their patient safety practices improved and 86.5% rated PSBT as beneficial for enhancing skill competencies. All male students and 97% of the female students agreed that PSBT enhanced their confidence in the safe holding of newborns. Moreover, 93% of participants were satisfied with PSBT. Conclusion: Omani undergraduate nursing students perceived that PSBT enhanced their knowledge, skills, patient safety practices and confidence levels in providing maternity care. These findings support the use of simulation training as a strategy to facilitate clinical learning outcomes in future nursing courses in Oman, although further research is needed to explore the objective impact of PSBT on learning outcomes.