WorldWideScience

Sample records for clinical outcome measures

  1. CLINICAL OUTCOME MEASURES OF PSORIASIS

    Directory of Open Access Journals (Sweden)

    E. Berardesca

    2011-09-01

    Full Text Available Several tools have been introduced in clinical trials to quantify the severity and the response to a given therapeutic regimen of both psoriasis and psoriatic arthritis. Each method present specific advantages and limitations. Here we will discuss some of the most popular clinical outcome measures of both psoriasis (Psoriasis Severity Index, Physician Global Assessment, National Psoriasis Fundation-Psoriasis Score, Dermatology Life Quality Index and psoriatic arthritis (American College Rheumatology response criteria, Psoriatic Arthritis Response Criteria. Key words: Psoriasis, psoriatic arthritis, outcome

  2. CLINICAL OUTCOME MEASURES OF PSORIASIS

    OpenAIRE

    E. Berardesca; Bonifati, C

    2011-01-01

    Several tools have been introduced in clinical trials to quantify the severity and the response to a given therapeutic regimen of both psoriasis and psoriatic arthritis. Each method present specific advantages and limitations. Here we will discuss some of the most popular clinical outcome measures of both psoriasis (Psoriasis Severity Index, Physician Global Assessment, National Psoriasis Fundation-Psoriasis Score, Dermatology Life Quality Index) and psoriatic arthritis (American College Rheu...

  3. Responsiveness of Clinical Outcome Measures

    DEFF Research Database (Denmark)

    Lauridsen, Henrik Hein

    Background The Oswestry Disability Index (ODI) is one of two standardised functional health measurement scales (HMS) recommended. Despite extensive psychometric testing, little is known about HMS behaviour and the minimal clinically important difference (MCID) in subgroups of LBP patients. Moreover...... in the primary (PrS) and secondary sectors (SeS) of the Danish health care system. The prospective acceptable outcome study. A method for estimating LBP patients' view of an acceptable change before treatment begins (MCIDpre was developed and compared to a well established retrospective method of determining...... measurement error and 1.5-4.5 times larger compared to the MCIDpost. Furthermore, the MCIDpre was almost comparable to patients' post-treatment acceptable change, but only for the pain scale. Conclusion The Danish version of the ODI is a reliable, valid and responsive HMS which is psychometrically more...

  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...... investigators agreed on the inclusion of trials and the outcome scale. For each trial, we calculated the difference in effect size (i.e., standardized mean difference between nonblinded and blinded assessments). A difference in effect size of less than 0 suggested that nonblinded assessors generated more...

  6. 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...... optimistic estimates of effect. We pooled the differences in effect size using inverse variance random-effects meta-analysis and used metaregression to identify potential reasons for variation. RESULTS: We included 24 trials in our review. The main meta-analysis included 16 trials (involving 2854 patients...

  7. Making the Best Match: Selecting Outcome Measures for Clinical Trials and Outcome Studies

    OpenAIRE

    Coster, Wendy J.

    2013-01-01

    Selecting an appropriate outcome measure is a critical step in designing valid and useful clinical trials and outcome studies. This selection process needs to extend beyond examining basic psychometric properties to consider additional features of instruments that may affect their validity and utility for the study’s purpose. This article discusses these additional factors and their potential impact on outcome measurement. Guidelines are proposed to help clinical researchers and consumers of ...

  8. Disability outcome measures in multiple sclerosis clinical trials

    DEFF Research Database (Denmark)

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

    2012-01-01

    Many of the available disability outcome measures used in clinical trials of multiple sclerosis are insensitive to change over time, inadequately validated, or insensitive to patient-perceived health status or quality of life. Increasing focus on therapies that slow or reverse disability...... progression makes it essential to refine existing measures or to develop new tools. Major changes to the expanded disability status scale should be avoided to prevent the loss of acceptance by regulators as a measure for primary outcomes in trials that provide substantial evidence of effectiveness. Rather, we......, 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...

  9. Possible clinical outcome measures for clinical trials in patients with multiple sclerosis

    Science.gov (United States)

    Goldman, Myla D.; Motl, Robert W.; Rudick, Richard A.

    2010-01-01

    Multiple sclerosis (MS) is a chronic inflammatory and neurodegenerative disease with both clinical and pathological heterogeneity. The complexity of the MS population has offered challenges to the measurement of MS disease progression in therapeutic trials. The current standard clinical outcome measures are relapse rate, Expanded Disability Severity Scale (EDSS), and the MS Functional Composite (MSFC). These measures each have strengths and some weakness. Two additional measures, the six-minute walk and accelerometry, show promise in augmenting current measures. MS therapeutics is a quickly advancing field which requires sensitive clinical outcome measures that can detect small changes in disability that reliably reflect long-term changes in sustained disease progression in a complex population. A single clinical outcome measure of sustained disease progression may remain elusive. Rather, an integration of current and new outcome measures may be most appropriate and utilization of different measures depending on the MS population and stage of the disease may be preferred. PMID:21179614

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

    Science.gov (United States)

    Trujillo, Adriana; Feixas, Guillem; Bados, Arturo; García-Grau, Eugeni; Salla, Marta; Medina, Joan Carles; Montesano, Adrián; Soriano, José; Medeiros-Ferreira, Leticia; Cañete, Josep; Corbella, Sergi; Grau, Antoni; Lana, Fernando; Evans, Chris

    2016-01-01

    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 questionnaire for monitoring the progress of Spanish-speaking psychotherapy clients.

  11. Outcome Measures for Clinical Trials in Interstitial Lung Diseases

    Science.gov (United States)

    Lammi, Matthew R.; Baughman, Robert P.; Birring, Surinder S.; Russell, Anne-Marie; Ryu, Jay H.; Scholand, Marybeth; Distler, Oliver; LeSage, Daphne; Sarver, Catherine; Antoniou, Katerina; Highland, Kristin B.; Kowal-Bielecka, Otylia; Lasky, Joseph A.; Wells, Athol U.; Saketkoo, Lesley Ann

    2015-01-01

    The chronic fibrosing idiopathic interstitial pneumonias (IIPs) are a group of heterogeneous pulmonary parenchymal disorders described by radiologic and histological patterns termed usual interstitial pneumonia (UIP) and non-specific interstitial pneumonia (NSIP). These include idiopathic pulmonary fibrosis (IPF) and those related to connective tissue disease (CTD) and are associated with substantial morbidity and mortality. Beyond the importance of establishing an appropriate diagnosis, designing optimal clinical trials for IIPs has been fraught with difficulties in consistency of clinical endpoints making power analyses, and the establishment of efficacy and interpretation of results across trials challenging. Preliminary recommendations, developed by rigorous consensus methods, proposed a minimum set of outcome measures, a ‘core set’, to be incorporated into future clinical trials (Saketkoo et al, THORAX. 2014.). This paper sets out to examine the candidate instruments for each domain (Dyspnea, Cough, Health Related Quality of Life, Imaging, Lung Physiology and Function, Mortality). Candidate measures that were not selected as well as measures that were not available for examination at the time of the consensus process will also be discussed. PMID:27019654

  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. Possible clinical outcome measures for clinical trials in patients with multiple sclerosis

    OpenAIRE

    Goldman, Myla D.; Motl, Robert W.; Rudick, Richard A.

    2010-01-01

    Multiple sclerosis (MS) is a chronic inflammatory and neurodegenerative disease with both clinical and pathological heterogeneity. The complexity of the MS population has offered challenges to the measurement of MS disease progression in therapeutic trials. The current standard clinical outcome measures are relapse rate, Expanded Disability Severity Scale (EDSS), and the MS Functional Composite (MSFC). These measures each have strengths and some weakness. Two additional measures, the six-minu...

  14. Outcome measurements in orthopedic

    OpenAIRE

    Bhandari, Mohit; Petrisor, Brad; Schemitsch, Emil

    2007-01-01

    The choice of outcome measure in orthopedic clinical research studies is paramount. The primary outcome measure for a study has several implications for the design and conduct of the study. These include: 1) sample size determination, 2) internal validity, 3) compliance and 4) cost. A thorough knowledge of outcome measures in orthopedic research is paramount to the conduct of a quality study. The decision to choose a continuous versus dichotomous outcome has important implications for sample ...

  15. A Systematic Review of Studies That Aim to Determine Which Outcomes to Measure in Clinical Trials in Children

    OpenAIRE

    Sinha, Ian; Jones, Leanne; Smyth, Rosalind L; Williamson, Paula R

    2008-01-01

    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 searche...

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

    International Nuclear Information System (INIS)

    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.)

  17. Alzheimer's disease biomarkers as outcome measures for clinical trials in MCI

    Science.gov (United States)

    Caroli, Anna; Prestia, Annapaola; Wade, Sara; Chen, Kewei; Ayutyanont, Napatkamon; Landau, Susan M.; Madison, Cindee M.; Haense, Cathleen; Herholz, Karl; Reiman, Eric M.; Jagust, William J.; Frisoni, Giovanni B.

    2014-01-01

    Background Aim of this study was to compare the performance and power of the best-established diagnostic biological markers as outcome measures for clinical trials in patients with mild cognitive impairment (MCI). Methods MRI, FDG-PET markers, and ADAS-COG were compared in terms of effect size and statistical power over different followup periods in two MCI groups, selected from ADNI dataset based on CSF (abnormal CSF Aβ1-42 concentration - ABETA+) or MRI evidence of Alzheimer's Disease (AD) (positivity to hippocampal atrophy - HIPPO+). Biomarkers progression was modeled through mixed effect models. Scaled slope was chosen as measure of effect size. Biomarkers power was estimated using simulation algorithms. Results Seventy-four ABETA+ and 51 HIPPO+ MCI patients were included in the study. Imaging biomarkers of neurodegeneration, especially MR measurements, showed highest performance. For all biomarkers and both MCI groups, power increased with increasing follow-up time, irrespective of biomarker assessment frequency. Conclusions These findings provide information about biomarker enrichment and outcome measurements that could be employed to reduce MCI patient samples and treatment duration in future clinical trials. PMID:25437302

  18. 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.

  19. The performance of the Health of the Nation Outcome Scales as measures of clinical severity.

    Science.gov (United States)

    Müller, Mario; Vandeleur, Caroline; Weniger, Godehard; Prinz, Susanne; Vetter, Stefan; Egger, Stephan T

    2016-05-30

    The aim of this study was to examine the performance of the Health of the Nation Outcome Scales (HoNOS) against other measures of functioning and mental health in a full three-year cohort of admissions to a psychiatric hospital. A sample of N=1719 patients (35.3% females, aged 17-78 years) was assessed using observer-rated measures and self-reports of psychopathology at admission. Self-reports were available from 51.7% of the sample (34.4% females, aged 17-76 years). Functioning and psychopathology were compared across five ICD-10 diagnostic groups: substance use disorders, schizophrenia and psychotic disorders, affective disorders, anxiety/somatoform disorders and personality disorders. Associations between the measures were examined, stratifying by diagnostic subgroup. The HoNOS were strongly linked to other measures primarily in psychotic disorders (except for the behavioral subscale), while those with substance use disorders showed rather poor links. Those with anxiety/somatoform disorders showed null or only small associations. This study raises questions about the overall validity of the HoNOS. It seems to entail different levels of validity when applied to different diagnostic groups. In clinical practice the HoNOS should not be used as a stand-alone instrument to assess outcome but rather as part of a more comprehensive battery including diagnosis-specific measures. PMID:27137958

  20. Prospective clinical trial comparing outcome measures between Furlow and von Langenbeck Palatoplasties for UCLP.

    Science.gov (United States)

    Williams, William N; Seagle, M Brent; Pegoraro-Krook, Maria Ines; Souza, Telma V; Garla, Luis; Silva, Marcos L; Machado Neto, José S; Dutka, Jeniffer C R; Nackashi, John; Boggs, Steve; Shuster, Jonathan; Moorhead, Jacquelyn; Wharton, William; Graciano, Maria I G; Pimentel, Maria C; Feniman, Mariza; Piazentin-Penna, Silvia H A; Kemker, Joseph; Zimmermann, Maria C; Bento-Gonçalvez, Cristina; Borgo, Hilton; Marques, Ilza L; Martinelli, Angela P M C; Jorge, José C; Antonelli, Patrick; Neves, Josiane F A; Whitaker, Melina E

    2011-02-01

    The goal of this prospective randomized clinical trial was to compare 2 cohorts of standardized cleft patients with regard to functional speech outcome and the presence or absence of palatal fistulae. The 2 cohorts are randomized to undergo either a conventional von Langenbeck repair with intravelar velarplasty or the double-opposing Z-plasty Furlow procedure. A prospective 2 × 2 × 2 factorial clinical trial was used in which each subject was randomly assigned to 1 of 8 different groups: 1 of 2 different lip repairs (Spina vs. Millard), 1 of 2 different palatal repair (von Langenbeck vs. Furlow), and 1 of 2 different ages at time of palatal surgery (9-12 months vs. 15-18 months). All surgeries were performed by the same 4 surgeons. A cul-de-sac test of hypernasality and a mirror test of nasal air emission were selected as primary outcome measures for velopharyngeal function. Both a surgeon and speech pathologist examined patients for the presence of palatal fistulae. In this study, the Furlow double-opposing Z-palatoplasty resulted in significantly better velopharyngeal function for speech than the von Langenbeck procedure as determined by the perceptual cul-de-sac test of hypernasality. Fistula occurrence was significantly higher for the Furlow procedure than for the von Langenbeck. Fistulas were more likely to occur in patients with wider clefts and when relaxing incisions were not used. PMID:21042188

  1. 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....

  2. 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

  3. Blue cone monochromacy: visual function and efficacy outcome measures for clinical trials.

    Directory of Open Access Journals (Sweden)

    Xunda Luo

    Full Text Available Blue Cone Monochromacy (BCM is an X-linked retinopathy caused by mutations in the OPN1LW / OPN1MW gene cluster, encoding long (L- and middle (M-wavelength sensitive cone opsins. Recent evidence shows sufficient structural integrity of cone photoreceptors in BCM to warrant consideration of a gene therapy approach to the disease. In the present study, the vision in BCM is examined, specifically seeking clinically-feasible outcomes for a future clinical trial.BCM patients (n = 25, ages 5-72 were studied with kinetic and static chromatic perimetry, full-field sensitivity testing, and eye movement recordings. Vision at the fovea and parafovea was probed with chromatic microperimetry.Kinetic fields with a Goldmann size V target were generally full. Short-wavelength (S- sensitive cone function was normal or near normal in most patients. Light-adapted perimetry results on conventional background lights were abnormally reduced; 600-nm stimuli were seen by rods whereas white stimuli were seen by both rods and S-cones. Under dark-adapted conditions, 500-nm stimuli were seen by rods in both BCM and normals. Spectral sensitivity functions in the superior retina showed retained rod and S-cone functions in BCM under dark-adapted and light-adapted conditions. In the fovea, normal subjects showed L/M-cone mediation using a 650-nm stimulus under dark-adapted conditions, whereas BCM patients had reduced sensitivity driven by rod vision. Full-field red stimuli on bright blue backgrounds were seen by L/M-cones in normal subjects whereas BCM patients had abnormally reduced and rod-mediated sensitivities. Fixation location could vary from fovea to parafovea. Chromatic microperimetry demonstrated a large loss of sensitivity to red stimuli presented on a cyan adapting background at the anatomical fovea and surrounding parafovea.BCM rods continue to signal vision under conditions normally associated with daylight vision. Localized and retina-wide outcome measures were

  4. 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…

  5. Interviewing to develop Patient-Reported Outcome (PRO) measures for clinical research: eliciting patients’ experience

    OpenAIRE

    Brédart, Anne; Marrel, Alexia; Abetz-Webb, Linda; Lasch, Kathy; Acquadro, Catherine

    2014-01-01

    Patient-reported outcome (PRO) measures must provide evidence that their development followed a rigorous process for ensuring their content validity. To this end, the collection of data is performed through qualitative interviews that allow for the elicitation of in-depth spontaneous reports of the patients’ experiences with their condition and/or its treatment. This paper provides a review of qualitative research applied to PRO measure development. A clear definition of what is a qualitative...

  6. Outcome measures for Charcot-Marie-Tooth disease: clinical and neurofunctional assessment in children

    OpenAIRE

    Pagliano, Emanuela; Moroni, Isabella; Baranello, Giovanni; Magro, Anita; Marchi, Alessia; Bulgheroni, Sara; Ferrarin, Maurizio; Pareyson, Davide

    2011-01-01

    Charcot-Marie-Tooth (CMT) disease is the most common inherited neuromuscular disorder, presenting with symptoms often occurring since childhood, and showing a progressive course. At present, there are no valid and reliable measures for evaluation of impairment and disability in the pediatric population. The aim of this study was to determine the usefulness of outcome measures, commonly used in adult patients, in CMT children. We report the results of a comprehensive evaluation of 21 children ...

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

    OpenAIRE

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

    2014-01-01

    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 sport...

  8. 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.

  9. 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

  10. Neurocognition: Clinical and Functional Outcomes in Schizophrenia

    OpenAIRE

    Lepage, Martin; Bodnar, Michael; Bowie, Christopher R.

    2014-01-01

    Schizophrenia is characterized by significant heterogeneity in outcome. The last decades have witnessed a significant interest in identifying factors that can moderate or influence clinical and functional outcomes in people with schizophrenia. One factor of particular interest is neurocognition, as performance on various measures of cognitive abilities, such as memory, attention, and executive functions, have been consistently related to functional outcome and, to a lesser extent, clinical ou...

  11. Why Measure Outcomes?

    Science.gov (United States)

    Kuhn, John E

    2016-01-01

    The concept of measuring the outcomes of treatment in health care was promoted by Ernest Amory Codman in the early 1900s, but, until recently, his ideas were generally ignored. The forces that have advanced outcome measurement to the forefront of health care include the shift in payers for health care from the patient to large insurance companies or government agencies, the movement toward assessing the care of populations not individuals, and the effort to find value (or cost-effective treatments) amid rising healthcare costs. No ideal method exists to measure outcomes, and the information gathered depends on the reason the outcome information is required. Outcome measures used in research are best able to answer research questions. The methods for assessing physician and hospital performance include process measures, patient-experience measures, structure measures, and measures used to assess the outcomes of treatment. The methods used to assess performance should be validated, be reliable, and reflect a patient's perception of the treatment results. The healthcare industry must measure outcomes to identify which treatments are most effective and provide the most benefit to patients. PMID:27049223

  12. Responsiveness and Minimal Clinically Important Change: A Comparison Between 2 Shoulder Outcome Measures

    DEFF Research Database (Denmark)

    Christiansen, David H.; Frost, Poul; Falla, Debora; Haahr, Jens Peder; Frich, Lars Henrik; Svendsen, Susanne W.

    2015-01-01

    Study Design A prospective cohort study nested in a randomized controlled trial. Objectives To determine and compare responsiveness and minimal clinically important change of the modified Constant score (CS) and the Oxford Shoulder Score (OSS). Background The OSS and the CS are commonly used to a...

  13. 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. PMID:26377989

  14. Effectiveness of a measurement feedback system on outcome in rheumatoid arthritis: a controlled clinical trial

    OpenAIRE

    Fransen, J.; Stucki, G.; Twisk, J.; Chamot, A; Gerster, J; Langenegger, T; Seitz, M; Michel, B.; m the,

    2003-01-01

    Background: With the help of a measurement feedback system, the treatment strategy for individual patients with rheumatoid arthritis (RA) can be adjusted to achieve optimal control of disease activity.

  15. Which outcome measures in SLE clinical trials best reflect medical judgment?

    OpenAIRE

    Thanou, Aikaterini; Chakravarty, Eliza; Judith A James; Merrill, Joan T.

    2014-01-01

    Objectives To compare two measures of systemic lupus erythematosus (SLE) response: the British Isles Lupus Assessment Group (BILAG)-based Composite Lupus Assessment (BICLA) and the Systemic Lupus Responder Index (SRI) against a clinician's assessment of improvement. Methods Ninety-one lupus patients were identified with two visits at which Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) and BILAG had been scored and with active disease (SLEDAI≥6) at the first visit. A physician r...

  16. 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…

  17. 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.

    OpenAIRE

    Mannil, M.; Solari, A.; Leha, A.; Pelayo-Negro, A. L.; Berciano, J; Schlotter-Weigel, B.; Walter, M.C.; Rautenstrauss, B.; Schnizer, T. J.; Schenone, A.; Seeman, P; Kadian, C.; Schreiber, O.; Angarita, N. G.; Fabrizi, G.M.

    2014-01-01

    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 ...

  18. Association between nutritional risk and routine clinical laboratory measurements and adverse outcomes: a prospective study in hospitalized patients of wuhan tongji hospital

    OpenAIRE

    Chen, Z. Y.; Gao, C.; Ye, T; Zuo, X Z; G. H. Wang; Xu, X. S.; Yao, Y

    2014-01-01

    Background/Objectives: Nutritional risk screening (NRS-2002) and routine clinical laboratory measurements (RCLMs) had been shown to have a predictive value in adverse outcomes in some studies, respectively. This study analyzed the association between NRS-2002 and RCLMs and estimated their prospective value in predicting adverse outcomes. Subjects/Methods: A total of 916 hospitalized patients were screened on admission with NRS-2002 and Subjective Global Assessment; RCLMs, which include blood ...

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

    OpenAIRE

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

    2014-01-01

    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. T...

  20. Functional recovery measures for spinal cord injury : An evidence-based review for clinical practice and research - Functional recovery outcome measures work group

    NARCIS (Netherlands)

    Anderson, Kim; Aito, Sergio; Atkins, Michal; Biering-Sorensen, Fin; Charlifue, Susan; Curt, Armin; Ditunno, John; Glass, Clive; Marino, Ralph; Marshall, Ruth; Mulcahey, Mary Jane; Post, Marcel; Savic, Gordana; Scivoletto, Giorgio; Catz, Amiram

    2008-01-01

    Background/Objective: The end goal of clinical care and clinical research involving spinal cord injury (SCI) is to improve the overall ability of persons living with SCI to function on a daily basis. Neurologic recovery does not always translate into functional recovery. Thus, sensitive outcome meas

  1. 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

  2. Retrodiction of Generalised Measurement Outcomes

    OpenAIRE

    Chefles, Anthony; Sasaki, Masahide

    2002-01-01

    If a generalised measurement is performed on a quantum system and we do not know the outcome, are we able to retrodict it with a second measurement? We obtain a necessary and sufficient condition for perfect retrodiction of the outcome of a known generalised measurement, given the final state, for an arbitrary initial state. From this, we deduce that, when the input and output Hilbert spaces have equal (finite) dimension, it is impossible to perfectly retrodict the outcome of any fine-grained...

  3. 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. PMID:25085517

  4. Measurement scales in clinical research of the upper extremity, part 2: outcome measures in studies of the hand/wrist and shoulder/elbow.

    Science.gov (United States)

    Badalamente, Marie; Coffelt, Laureen; Elfar, John; Gaston, Glenn; Hammert, Warren; Huang, Jerry; Lattanza, Lisa; Macdermid, Joy; Merrell, Greg; Netscher, David; Panthaki, Zubin; Rafijah, Greg; Trczinski, Douglas; Graham, Brent

    2013-02-01

    Part 1 of this article outlined the basic characteristics of useful clinical measurement instruments and described scales used to measure general health, pain, and patient satisfaction. Part 2 describes the features of some of the scales most commonly used in clinical research in the hand, wrist, elbow, and shoulder. PMID:23351913

  5. Creating clinical trial designs that incorporate clinical outcome assessments.

    Science.gov (United States)

    Gilbert, Mark R; Rubinstein, Lawrence; Lesser, Glenn

    2016-03-01

    Clinical outcome assessments (COAs) are increasingly being used in determining the efficacy of new treatment regimens. This was typified in the recent use of a symptom-based instrument combined with an organ-based measure of response for the approval of ruxolitinib in myelofibrosis. There are challenges in incorporating these COAs into clinical trials, including designating the level of priority, incorporating these measures into a combined or composite endpoint, and dealing with issues related to compliance and interpretation of results accounting for missing data. This article describes the results of a recent panel discussion that attempted to address these issues and provide guidance to the incorporation of COAs into clinical trials, including novel statistical designs, so that the testing of new treatments in patients with cancers of the central nervous system can incorporate these important clinical endpoints. PMID:26989129

  6. Measurement outcomes from hip simulators.

    Science.gov (United States)

    de Villiers, Danielle; Shelton, Julia C

    2016-05-01

    Simulation of wear in total hip replacements has been recognised as an important factor in determining the likelihood of clinical success. However, accurate measurement of wear can be problematic with factors such as number and morphology of wear particles produced as well as ion release proving more important in the biological response to hip replacements than wear volume or wear rate alone. In this study, hard-on-hard (CoCr alloy, AgCrN coating) and hard-on-soft (CoCr alloy and CrN coating on vitamin E blended highly cross-linked polyethylene) bearing combinations were tested in an orbital hip simulator under standard and some adverse conditions. Gravimetric wear rates were determined for all bearings, with cobalt and where applicable, silver release determined throughout testing. Isolation of wear particles from the lubricating fluid was used to determine the influence of different bearing combinations and wear conditions on particle morphology. It was found that cobalt and silver could be measured in the lubricating fluid even when volumetric wear was not detectable. In hard-on-hard bearings, Pearson's correlation of 0.98 was established between metal release into the lubricating fluid and wear volume. In hard-on-soft bearings, coating the head did not influence the polyethylene wear rates measured under standard conditions but did influence the cobalt release; the diameter influenced both polyethylene wear and cobalt release, and the introduction of adverse testing generated smaller polyethylene particles. While hip simulators can be useful to assess the wear performance of a new material or design, measurement of other outcomes may yield greater insight into the clinical behaviour of the bearings in vivo. PMID:26888886

  7. 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.

  8. Outcome Prediction in Clinical Treatment Processes.

    Science.gov (United States)

    Huang, Zhengxing; Dong, Wei; Ji, Lei; Duan, Huilong

    2016-01-01

    Clinical outcome prediction, as strong implications for health service delivery of clinical treatment processes (CTPs), is important for both patients and healthcare providers. Prior studies typically use a priori knowledge, such as demographics or patient physical factors, to estimate clinical outcomes at early stages of CTPs (e.g., admission). They lack the ability to deal with temporal evolution of CTPs. In addition, most of the existing studies employ data mining or machine learning methods to generate a prediction model for a specific type of clinical outcome, however, a mathematical model that predicts multiple clinical outcomes simultaneously, has not yet been established. In this study, a hybrid approach is proposed to provide a continuous predictive monitoring service on multiple clinical outcomes. More specifically, a probabilistic topic model is applied to discover underlying treatment patterns of CTPs from electronic medical records. Then, the learned treatment patterns, as low-dimensional features of CTPs, are exploited for clinical outcome prediction across various stages of CTPs based on multi-label classification. The proposal is evaluated to predict three typical classes of clinical outcomes, i.e., length of stay, readmission time, and the type of discharge, using 3492 pieces of patients' medical records of the unstable angina CTP, extracted from a Chinese hospital. The stable model was characterized by 84.9% accuracy and 6.4% hamming-loss with 3 latent treatment patterns discovered from data, which outperforms the benchmark multi-label classification algorithms for clinical outcome prediction. Our study indicates the proposed approach can potentially improve the quality of clinical outcome prediction, and assist physicians to understand the patient conditions, treatment inventions, and clinical outcomes in an integrated view. PMID:26573645

  9. 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 ...... 12 years survival data, are comparable with the literature. PAO is considered as an effective treatment for young adults with painful hip dysplasia, especially when preoperative criteria for conversion to THA are highlighted.......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 patients with PAO. BASIC PROCEDURES: In the period 1999-2008, 93 patients (127 hips, median patient age 31, range 13-49 years) were operated on with PAO. Median follow-up was 7 (SD 2.1) years. Analyses of clinical and radiographic examinations, including WOMAC, were performed. Osteoarthritis was measured...

  10. 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

  11. 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. PMID:25300613

  12. Can cerebral blood flow measurement predict clinical outcome in the acute phase in patients with artherosclerotic occlusive carotid artery disease?

    International Nuclear Information System (INIS)

    It has been thought that the clinical course of patients with acute carotid occlusive disease depends on their collateral cerebral blood flow (CBF) and duration of ischemia. However, there have been few clinical reports to prove this hypothesis. Therefore, we performed CBF study in patients with artherosclerotic carotid occlusive disease in the very acute phase, and precisely assessed the prognosis of those patients under intensive medical therapy. This prospective study included a total of 44 patients (72±13 years) who were admitted to our hospital between April, 2007 and December, 2008. To evaluate their initial CBF, single photon emission computed tomography (SPECT) studies were performed within 6 hours after the onset. All patients included in this study were medically treated and were periodically followed up by neurological and radiological examination. Moreover, in patients with reduced CBF (ipsilateral CBF/contralateral CBF x 100: %CBF <80%), dobutamine-induce hyperdynamic therapy was performed. Multivariate analysis was performed to detect significant predictors for the occurrence of further cerebral infarction. Multivariate analysis showed that the occurrence of further infarction was associated with older age and smaller %CBF. Of 44 patients, 21 experienced further cerebral infarction within 10 days after onset. Fourteen out of 15 patients with %CBF <60% developed cerebral infarction. This study showed that the prognosis of the patients with artherosclerotic carotid occlusive disease in the acute phase is associated with their initial residual CBFs. It may be difficult to stop the developed cerebral infarction in those patients with %CBF <60% despite intensive medical therapy. (author)

  13. Clinical utility of urine neutrophil gelatinase-associated lipocalin measured at admission to predict outcomes in heterogeneous population of critically ill patients

    Science.gov (United States)

    Nayak, N. M.; Madhumitha, S.; Annigeri, R. A.; Venkataraman, R.; Balasubramaian, S.; Seshadri, R.; Vadamalai, V.; Rao, B. S.; Kowdle, P. C.; Ramakrishnan, N.; Mani, M. K.

    2016-01-01

    Urine neutrophil gelatinase-associated lipocalin (uNGAL) is a reliable early biomarker of acute kidney injury (AKI) in a homogeneous patient population. However, its utility in a heterogeneous population of critically ill, in whom the time of onset of renal insult is often unclear, is not clearly established. We evaluated the ability of a single measurement of uNGAL in a heterogeneous adult population, on admission to intensive care unit (ICU), to predict the occurrence of AKI and hospital mortality. One hundred and two consecutive adult patients had uNGAL measured within 8 h of admission to ICU. The demographic and laboratory data were collected at admission. The diagnosis of AKI was based on AKI Network (AKIN) criteria. The primary outcome was the development of AKI, and the secondary outcome was hospital mortality. The mean age was 54 ± 16.4 years and 65% were males. Urine NGAL (ng/ml) was 69 ± 42 in patients with AKI (n = 42) and 30.4 ± 41.7 in those without AKI (P 75 ng/ml was a strong (odd ratio = 5.17, 95% confidence interval: 1.39–19.3) and independent predictor of hospital mortality. A single measurement of uNGAL at admission to ICU exhibited good predictive ability for AKI though the sensitivity was low. The predictive ability of uNGAL was inferior to simultaneously measured SCr at admission, hence limited its clinical utility to predict AKI. However, admission uNGAL was a strong, independent predictor of hospital mortality. PMID:27051136

  14. Impact of diffusion-weighted MRI-measured initial cerebral infarction volume on clinical outcome in acute stroke patients with middle cerebral artery occlusion treated by thrombolysis

    Energy Technology Data Exchange (ETDEWEB)

    Sanak, Daniel; Bartkova, Andrea; Herzig, Roman; Skoloudik, David; Vlachova, Ivanka; Kanovsky, Petr [University Hospital, Stroke Center, Department of Neurology, Olomouc (Czech Republic); Nosal' , Vladimir; Kurca, Egon [University Hospital, Department of Neurology, Martin (Slovakia); Horak, David; Bucil, Jiri; Burval, Stanislav; Koecher, Martin [University Hospital, Stroke Center, Department of Radiology, Olomouc (Czech Republic); Zelenak, Kamil; Cisarikova, Viera [University Hospital, Department of Radiology, Martin (Slovakia); Zapletalova, Jana [Palacky University Medical School, Department of Biometry and Statistics, Olomouc (Czech Republic)

    2006-09-15

    Magnetic resonance imaging (MRI) may help identify acute stroke patients with a higher potential benefit from thrombolytic therapy. The aim of our study was to assess the correlation between initial cerebral infarct (CI) volume (quantified on diffusion-weighted MRI) and the resulting clinical outcome in acute stroke patients with middle cerebral artery (MCA) (M{sub 1-2} segment) occlusion detected on MRI angiography treated by intravenous/intraarterial thrombolysis. Initial infarct volume (V{sub DWI-I}) was retrospectively compared with neurological deficit evaluated using the NIH stroke scale on admission and 24 h later, and with the 90-day clinical outcome assessed using the modified Rankin scale in a series of 25 consecutive CI patients. The relationship between infarct volume and neurological deficit severity was assessed and, following the establishment of the maximum V{sub DWI-I} still associated with a good clinical outcome, the patients were divided into two groups (V{sub DWI-I} {<=}70 ml and >70 ml). V{sub DWI-I} ranged from 0.7 to 321 ml. The 24-h clinical outcome improved significantly (P=0.0001) in 87% of patients with a V{sub DWI-I} {<=}70 ml (group 1) and deteriorated significantly (P=0.0018) in all patients with a V{sub DWI-I} >70 ml (group 2). The 90-day mortality was 0% in group 1 and 71.5% in group 2. The 90-day clinical outcome was significantly better in group 1 than in group 2 (P=0.026). Clinical outcome could be predicted from initial infarct volume quantified by MRI-DWI in acute CI patients with MCA occlusion treated by intravenous/intraarterial thrombolysis. Patients with a V{sub DWI-I} {<=}70 ml had a significantly better outcome. (orig.)

  15. Core Outcome Measures in Effectiveness Trials (COMET) initiative: protocol for an international Delphi study to achieve consensus on how to select outcome measurement instruments for outcomes included in a ‘core outcome set’

    OpenAIRE

    Prinsen, Cecilia A C; Vohra, Sunita; Rose, Michael R.; King-Jones, Susanne; Ishaque, Sana; Bhaloo, Zafira; Adams, Denise; Terwee, Caroline B

    2014-01-01

    Background The Core Outcome Measures in Effectiveness Trials (COMET) initiative aims to facilitate the development and application of ‘core outcome sets’ (COS). A COS is an agreed minimum set of outcomes that should be measured and reported in all clinical trials of a specific disease or trial population. The overall aim of the Core Outcome Measurement Instrument Selection (COMIS) project is to develop a guideline on how to select outcome measurement instruments for outcomes included in a COS...

  16. Routine outcome measures in Canada.

    Science.gov (United States)

    Kisely, Steve; Adair, Carol E; Lin, Elizabeth; Marriott, Brian

    2015-01-01

    Canada is a federal country of 10 provinces and three territories. High level information on mental health conditions and service use has mostly been generated from administrative data collected by provinces and territories. These include four major types - hospital admissions and discharges, physician billings, ambulatory care services, and drug databases. At the national level, the Canadian Institute for Health Information brings together this information to produce indicators of outcome. Although these data provide information on patient and health system characteristics, they do not capture the full spectrum of formal and informal mental healthcare. These include changes in health status, functioning, community integration and quality of life. As a result, some jurisdictions have begun to implement more standardized measures of outcome such as the clinician-rated Health of the Nation Outcome Scales or the inpatient Resident Assessment Instrument - Mental Health. In this paper we provide an overview of mental-health-related data sources in Canada, highlight some of the more progressive practices beginning to emerge, and conclude with some thoughts about how the routine measurement and reporting of mental health outcomes in Canada might be advanced including efforts at engaging both clinicians and decision-makers. PMID:25738745

  17. 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 of...

  18. 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

  19. Endoscopic ultrasonic dacryocystorhinostomy: clinical profile and outcomes.

    Science.gov (United States)

    Ali, Mohammad Javed; Singh, Manpreet; Chisty, Naja; Kamal, Saurabh; Naik, Milind N

    2016-07-01

    Ultrasonic endoscopic dacryocystorhinostomy (UEnDCR) is emerging alternative modality of managing nasolacrimal duct obstructions. The aim of this study was to report the clinical profile and outcomes with a UEnDCR with mitomycin C and silicone intubation. Prospective interventional case series performed on all consecutive patients undergoing an ultrasonic endoscopic dacryocystorhinostomy over a 1-year period from September 2013 to October 2014. All surgeries were performed by a single surgeon (MJA). Data collected include demographics, presentation, indications for surgery, past interventions, intraoperative and post-operative complications and outcomes. The main outcome measures were anatomical and functional success of the surgery. 44 procedures were performed in 41 patients. The mean age was 31.6 years. Children with complex congenital nasolacrimal duct obstructions refractory to probing and intubation accounted for 17 % (7/41) of the cohort. Past history of acute dacryocystitis was noted in 35.6 % (15/41). Two patients (4.9 %, 2/41) had failed external DCR. A minimal follow-up of 6 months following surgery was taken for final analysis. Complications included intraoperative focal epithelial burn in one patient that healed spontaneously and post-operative ostium granulomas in 15.9 % (7/44) of the ostia. At the 6-month follow-up, anatomical and functional successes were noted in 93.1 % (41/44) and 88.6 % (39/44), respectively. Ultrasonic dacryocystorhinostomy is a safe and effective alternative modality in the management of nasolacrimal duct obstructions in pediatric and adult age groups. Setup was easy and no additional technical difficulties were observed. PMID:26530294

  20. Functional outcomes for clinical evaluation of implant restorations.

    Science.gov (United States)

    Bassi, Francesco; Carr, Alan B; Chang, Ting-Ling; Estafanous, Emad W; Garrett, Neal R; Happonen, Risto-Pekka; Koka, Sreenivas; Laine, Juhani; Osswald, Martin; Reintsema, Harry; Rieger, Jana; Roumanas, Eleni; Salinas, Thomas J; Stanford, Clark M; Wolfaardt, Johan

    2013-01-01

    The functional outcomes related to treating patients afflicted with tooth loss are an important hallmark in substantiating prosthodontic intervention. The Oral Rehabilitation Outcomes Network (ORONet) conducted two international workshops to develop a core set of outcome measures, including a functional domain. The process followed the general format used in the Outcome Measures in Rheumatology (OMERACT) workshops to develop consensus for clinical outcome measures in arthritis research, which included: developing a comprehensive list of potential outcomes in the literature; submitting them to a filter for validity, clinical discrimination, and feasibility; and ranking those measures meeting all the filter criteria for relative value. The search was conducted to include functional assessments of speech, swallowing, mastication, nutrition, sensation, and motor function as they relate to dental implant therapies. This literature review surveyed 173 papers that produced some result of these descriptors in the functional domain. Of these, 67 papers reported on functional assessments and further defined objective and subjective outcomes. Many of these results were patient-perceived improvements in function, while others were objective assessments based on established methodologies and instruments. Objective evaluations of masticatory function and speech may meet criteria for validity and discriminability for selected interventions, but are generally not feasible for routine use in clinical care settings. The current recommendation is to employ a well-validated survey instrument that covers mastication and speech, such as the Oral Health Impact Profile (OHIP-14, short form), recognizing that patient perceptions of function may differ from objective ability. PMID:23998137

  1. 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...

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

    DEFF Research Database (Denmark)

    Reekie, J; Mocroft, A; J, Neaton; Lundgren, Jens Dilling

    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...... the infection, so when treatment is started it is currently a lifelong commitment. Is it reasonable then that guidelines are based almost completely on short-term randomized trials and observational studies of surrogate markers, or is there still a need for trials with clinical outcomes?...

  3. Developing core outcome sets for clinical trials: issues to consider

    Directory of Open Access Journals (Sweden)

    Williamson Paula R

    2012-08-01

    Full Text Available Abstract The selection of appropriate outcomes or domains is crucial when designing clinical trials in order to compare directly the effects of different interventions in ways that minimize bias. If the findings are to influence policy and practice then the chosen outcomes need to be relevant and important to key stakeholders including patients and the public, health care professionals and others making decisions about health care. There is a growing recognition that insufficient attention has been paid to the outcomes measured in clinical trials. These issues could be addressed through the development and use of an agreed standardized collection of outcomes, known as a core outcome set, which should be measured and reported, as a minimum, in all trials for a specific clinical area. Accumulating work in this area has identified the need for general guidance on the development of core outcome sets. Key issues to consider in the development of a core outcome set include its scope, the stakeholder groups to involve, choice of consensus method and the achievement of a consensus.

  4. Fundamentals of Clinical Outcomes Assessment for Spinal Disorders: Clinical Outcome Instruments and Applications.

    Science.gov (United States)

    Vavken, Patrick; Ganal-Antonio, Anne Kathleen B; Quidde, Julia; Shen, Francis H; Chapman, Jens R; Samartzis, Dino

    2015-08-01

    Study Design A broad narrative review. Objectives Outcome assessment in spinal disorders is imperative to help monitor the safety and efficacy of the treatment in an effort to change the clinical practice and improve patient outcomes. The following article, part two of a two-part series, discusses the various outcome tools and instruments utilized to address spinal disorders and their management. Methods A thorough review of the peer-reviewed literature was performed, irrespective of language, addressing outcome research, instruments and tools, and applications. Results Numerous articles addressing the development and implementation of health-related quality-of-life, neck and low back pain, overall pain, spinal deformity, and other condition-specific outcome instruments have been reported. Their applications in the context of the clinical trial studies, the economic analyses, and overall evidence-based orthopedics have been noted. Additional issues regarding the problems and potential sources of bias utilizing outcomes scales and the concept of minimally clinically important difference were discussed. Conclusion Continuing research needs to assess the outcome instruments and tools used in the clinical outcome assessment for spinal disorders. Understanding the fundamental principles in spinal outcome assessment may also advance the field of "personalized spine care." PMID:26225283

  5. 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 E J; 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

  6. Preoperative indicators of clinical outcome following stereotaxic pallidotomy.

    Science.gov (United States)

    Kazumata, K; Antonini, A; Dhawan, V; Moeller, J R; Alterman, R L; Kelly, P; Sterio, D; Fazzini, E; Beric, A; Eidelberg, D

    1997-10-01

    We assessed the utility of preoperative clinical assessment and functional brain imaging with 18F-fluorodeoxyglucose (FDG) and positron emission tomography (PET) in predicting the clinical outcome of stereotaxic pallidotomy for the treatment of advanced Parkinson's disease (PD). Twenty-two PD patients undergoing posteroventral pallidotomy were assessed preoperatively with the Core Assessment Program for Intracerebral Transplantation (CAPIT) ratings measured on and off levodopa; quantitative FDG/PET was also performed before surgery. Preoperative clinical and metabolic measurements were correlated with changes in off-state CAPIT ratings determined 3 months after surgery. Clinical outcome following pallidotomy was also correlated with intraoperative measures of spontaneous pallidal single-unit activity as well as postoperative MRI measurements of lesion volume and location. We found that unilateral pallidotomy resulted in variable clinical improvement in off-state CAPIT scores for the contralateral limbs (mean change 30.9 +/- 15.5%). Postoperative MRI revealed that pallidotomy lesions were comparable in location and volume across the patients. Clinical outcome following surgery correlated significantly with preoperative measures of CAPIT score change with levodopa administration (r = 0.60, p < 0.005) and with preoperative FDG/PET measurements of lentiform glucose metabolism (r = 0.71, p < 0.0005). Operative outcome did not correlate with intraoperative measures of spontaneous pallidal neuronal firing rate. We conclude that preoperative measurements of lentiform glucose metabolism and levodopa responsiveness may be useful indicators of motor improvement following pallidotomy. Both preoperative quantitative measures, either singly or in combination, may be helpful in selecting optimal candidates for surgery. PMID:9339694

  7. 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...

  8. Outcome measures in inflammatory rheumatic diseases

    OpenAIRE

    Fransen, Jaap; van Riel, Piet LCM

    2009-01-01

    Inflammatory rheumatic diseases are generally multifaceted disorders and, therefore, measurement of multiple outcomes is relevant to most of these diseases. Developments in outcome measures in the rheumatic diseases are promoted by the development of successful treatments. Outcome measurement will increasingly deal with measurement of low levels of disease activity and avoidance of disease consequences. It is an advantage for patient management and knowledge transfer if the same outcomes are ...

  9. Clinical Outcomes after Traumatic Brain Injury.

    Science.gov (United States)

    Sandsmark, Danielle K

    2016-06-01

    Traumatic brain injury (TBI) is a major cause of death and disability that often affects young people. After injury, the degree of recovery can be highly variable, with some people regaining near complete function while others remain severely disabled. Understanding what factors influence recovery is important for counseling patients and families in the acute period after injury and can help guide therapeutic decisions in the acute period following injury. In this review, prognostic algorithms useful for clinicians are discussed. Tools for grading patient outcomes, their role in clinical care and research studies, and their limitations are reviewed. Ongoing work focusing on the development of biomarkers to track TBI recovery and the refinement of clinical outcome metrics is summarized. PMID:27072952

  10. Nocardiosis: Risk Factors, Clinical Characteristics and Outcome

    OpenAIRE

    Alavi Darazam, Ilad; Shamaei, Masoud; Mobarhan, Mandana; Ghasemi, Shahin; Tabarsi, Payam; Motavasseli, Masoud; Mansouri, Davood

    2013-01-01

    Nocardiosis has been reported increasingly in recent two decades, probably due to improvement in isolation of the organism and increased burden of immune compromised patients. Nocardia occasionally has been reported in healthy people. A case series of definitive Nocardiosis (2002 to 2010), clinical characteristics, underlying diseases, immune status and in-patient outcome were studied in a tertiary referral center. Twenty one patients with definite diagnosis of Nocardiosis were studied. 17 ca...

  11. Insular Ischemic Stroke: Clinical Presentation and Outcome

    OpenAIRE

    Lemieux, F.; Lanthier, S.; Chevrier, M.-C.; de Gioia, L.; I. Rouleau; Cereda, C.; Nguyen, D.K.

    2012-01-01

    Background The insula is a small but complex structure located in the depth of the sylvian fissure, covered by the frontal, parietal and temporal operculum. Ischemic strokes limited to the insula are rare and have not been well studied. Our objective is to better define the clinical presentation and outcome of insular ischemic strokes (IIS). Methods We reviewed the institutional prospective, consecutive stroke database from two centers to identify patients with IIS seen between 2008 and 2010....

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

    OpenAIRE

    Worth, Allison; Hammersley, Victoria; Knibb, Rebecca; Flokstra-de-Blok, Bertine; DunnGalvin, Audrey; Walker, Samantha; Dubois, Anthony E J; 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 and examine their potential for use in clinical settings. Methods: We systematically searched MEDLINE, EMBASE and Web of Science databases from 1990 onwards to identify PROMs for asthma. These were ...

  13. Multisystemic Therapy: Clinical Foundations and Research Outcomes

    Directory of Open Access Journals (Sweden)

    Scott W. Henggeler

    2012-07-01

    Full Text Available Multisystemic therapy (MST is an intensive family and community-based treatment for adolescents presenting serious antisocial behavior and their families. Using a home-based model of service delivery to overcome barriers to service access and a strong quality assurance system to promote treatment fidelity, MST therapists address known risk factors (i.e., at individual, family, peer, school, and community levels strategically and comprehensively. The family is viewed as central to achieving favorable outcomes, and mediation research supports the emphasis of MST on promoting family functioning as the key mechanism of clinical change. Importantly, 22 MST outcome studies have been published, many of which are independent randomized clinical trials, and the vast majority, including those conducted in Europe, support the capacity of MST to reduce youth antisocial behavior and out-of-home placements. Such outcomes, combined with the advocacy of many juvenile justice stakeholders, have led to the transport of MST programs to more than 500 sites, including 10 nations in Europe.

  14. Outcome measures in neuromuscular disease: is the world still flat?

    Science.gov (United States)

    Lunn, Michael P; Van den Bergh, Peter Y K

    2015-09-01

    Valid, responsive, and meaningful outcome measures for the measurement of the impairment, activity limitations, and quality of life in patients with neuromuscular disease are crucial to identify the natural history of disease and benefits of therapy in clinical practice and trials. Although understanding of many aspects of neuromuscular diseases has advanced dramatically, the development of outcome measures has received less attention. The scales developed from Rasch theory by the PeriNomS Group represent the biggest significant shift in thought in neuromuscular outcome measures for decades. There remain problems with many of them, and further developments are required. However, incorporating them into our outcome sets for daily use and in clinical trials will lead to the more efficient capture of meaningful change and will result in better assessment of individuals and groups of patients in both clinical trials and neurological practice. PMID:26114965

  15. Observer bias in randomised clinical trials with binary outcomes

    DEFF Research Database (Denmark)

    Hróbjartsson, Asbjørn; Thomsen, Ann Sofia Skou; Emanuelsson, Frida; Tendal, Britta; Hilden, Jørgen; Boutron, Isabelle; Ravaud, Philippe; Brorson, Stig

    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....

  16. The clinical outcome of scaphoid fracture malunion at 1 year.

    Science.gov (United States)

    Forward, D P; Singh, H P; Dawson, S; Davis, T R C

    2009-02-01

    The aim of this study was to assess the effect of malunion of scaphoid fractures on the clinical outcome at 1 year. Forty-two consecutive patients with united scaphoid waist fractures which had been treated non-operatively underwent longitudinal CT scans to confirm union and assess malunion at 12 to 18 weeks after injury. A blind clinical assessment was made and the Patient Evaluation Measure (PEM) and DASH questionnaires were completed by all the patients 1 year after injury. The group consisted of 38 men and four women with a mean age of 31 years at the time of injury. Correlation analysis revealed no significant relationships between any of the outcome measures (range of motion, grip strength and PEM and DASH scores) and any of the three measures of malunion (height-to-length ratio, the dorsal cortical angle and the lateral intra-scaphoid angle). PMID:19129358

  17. 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.)

  18. Pyogenic sacroiliitis: diagnosis, management and clinical outcome

    International Nuclear Information System (INIS)

    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.)

  19. 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.

  20. Scrub typhus: Clinical spectrum and outcome

    Directory of Open Access Journals (Sweden)

    Pradeep M Venkategowda

    2015-01-01

    Full Text Available Background: Scrub typhus is one of the differential diagnoses for fever with thrombocytopenia. ARDS associated with Scrub typhus has high morbidity and mortality. Aims: To evaluate clinical features, lab values, and outcome in patients with scrub typhus and comparison in patients with or without ARDS. Methods: A prospective observational study was conducted on 109 patients with febrile illness and thrombocytopenia during a period of 12 months. All 109 patients were tested with both Immune-chromatography test and Weil felix test. Patients having either Immune-chromatography test/Weil felix test positive have been included and considered as scrub typhus positive whereas negative for both Immune-chromatography and Weil felix test were excluded. Clinical features, lab parameters, and outcome were evaluated in all patients with scrub typhus. Statistical analysis used in this study was T-test. Results: Among 58 patients who were included (After exclusion of 51 patients among total of 109 patients 34 patients had no ARDS and 24 patients had ARDS. The clinical feature like dyspnoea, cough, low blood pressure (MAP<65 mmHg, IVC collapsibility (by ultrasound and laboratory parameters like decreased Hemoglobin, Hematocrit, Serum albumin, and increased serum creatinine, serum total bilirubin, SGOT, SGPT, LDH, CPK, and serum lactate were statistically significant (P < 0.0001 in scrub typhus patients group with ARDS. The higher titers of Weil-felix can be correlated with more severe form of disease according to our observation. All 34 Scrub typhus patients without ARDS recovered completely. Among 24 Scrub typhus patients with ARDS, 22 patients recovered, and 2 patients died. Conclusion: Scrub typhus is an important differential diagnosis in a patients having fever with thrombocytopenia. Scrub typhus associated with ARDS has high morbidity and mortality. Early diagnosis and treatment with doxycycline can prevent the occurrence of ARDS

  1. 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....

  2. Clinical Outcome Assessments: Conceptual Foundation-Report of the ISPOR Clinical Outcomes Assessment - Emerging Good Practices for Outcomes Research Task Force.

    Science.gov (United States)

    Walton, Marc K; Powers, John H; Hobart, Jeremy; Patrick, Donald; Marquis, Patrick; Vamvakas, Spiros; Isaac, Maria; Molsen, Elizabeth; Cano, Stefan; Burke, Laurie B

    2015-09-01

    An outcome assessment, the patient assessment used in an endpoint, is the measuring instrument that provides a rating or score (categorical or continuous) that is intended to represent some aspect of the patient's health status. Outcome assessments are used to define efficacy endpoints when developing a therapy for a disease or condition. Most efficacy endpoints are based on specified clinical assessments of patients. When clinical assessments are used as clinical trial outcomes, they are called clinical outcome assessments (COAs). COAs include any assessment that may be influenced by human choices, judgment, or motivation. COAs must be well-defined and possess adequate measurement properties to demonstrate (directly or indirectly) the benefits of a treatment. In contrast, a biomarker assessment is one that is subject to little, if any, patient motivational or rater judgmental influence. This is the first of two reports by the ISPOR Clinical Outcomes Assessment - Emerging Good Practices for Outcomes Research Task Force. This report provides foundational definitions important for an understanding of COA measurement principles. The foundation provided in this report includes what it means to demonstrate a beneficial effect, how assessments of patients relate to the objective of showing a treatment's benefit, and how these assessments are used in clinical trial endpoints. In addition, this report describes intrinsic attributes of patient assessments and clinical trial factors that can affect the properties of the measurements. These factors should be considered when developing or refining assessments. These considerations will aid investigators designing trials in their choice of using an existing assessment or developing a new outcome assessment. Although the focus of this report is on the development of a new COA to define endpoints in a clinical trial, these principles may be applied more generally. A critical element in appraising or developing a COA is to

  3. Abdominal tuberculosis: clinical presentation and outcome

    International Nuclear Information System (INIS)

    To study the clinical presentation and outcome of cases of Abdominal Tuberculosis. Fifty four patients of Abdominal Tuberculosis were seen during the study period. Four patients were lost to follow-up, which were excluded. Detailed information of all the patients including age, sex, symptoms, signs, investigations and management was recorded, analyzed and compared with local and international data. Out of the 50 patients with Abdominal Tuberculosis, 31 were females and 19 males. Their ages ranged from 17 to 63 years, with a mean age of 25.1 years. Thirty five cases were admitted through Emergency and 15 through Outpatients departments. Abdominal pain was the most common symptom found in 44 (88%) patients followed by vomiting in 33 (66%). Abdominal tenderness was seen in 22 (44%) patients, while 16 (32%) patients had rigidity and other features of peritonitis. Surgery was performed in all these patients, limited right hemicolectomy in 17 (34%), segmental resection and anastomosis in 12 (24%), ileostomy and strictureplasty in six (12%) each, repair of perforation in five (10%) and adhesiolysis in four (8%) patients. Overall mortality was 8% due to septicaemia and multiorgan failure. Abdominal Tuberculosis is a significant clinical entity with lethal complications in neglected cases. It affects a younger age group and is more common in females. Clinical features are rather non-specific but vague ill health, low grade fever, weight loss and anorexia may help to diagnose the case. (author)

  4. Cytokines and signaling molecules predict clinical outcomes in sepsis.

    Directory of Open Access Journals (Sweden)

    Christopher D Fjell

    Full Text Available INTRODUCTION: Inflammatory response during sepsis is incompletely understood due to small sample sizes and variable timing of measurements following the onset of symptoms. The vasopressin in septic shock trial (VASST compared the addition of vasopressin to norepinephrine alone in patients with septic shock. During this study plasma was collected and 39 cytokines measured in a 363 patients at both baseline (before treatment and 24 hours. Clinical features relating to both underlying health and the acute organ dysfunction induced by the severe infection were collected during the first 28 days of admission. HYPOTHESIS: Cluster analysis of cytokines identifies subgroups of patients at differing risk of death and organ failure. METHODS: Circulating cytokines and other signaling molecules were measured using a Luminex multi-bead analyte detection system. Hierarchical clustering was performed on plasma values to create patient subgroups. Enrichment analysis identified clinical outcomes significantly different according to these chemically defined patient subgroups. Logistic regression was performed to assess the importance of cytokines for predicting patient subgroups. RESULTS: Plasma levels at baseline produced three subgroups of patients, while 24 hour levels produced two subgroups. Using baseline cytokine data, one subgroup of 47 patients showed a high level of enrichment for severe septic shock, coagulopathy, renal failure, and risk of death. Using data at 24 hours, a larger subgroup of 81 patients that largely encompassed the 47 baseline subgroup patients had a similar enrichment profile. Measurement of two cytokines, IL2 and CSF2 and their product were sufficient to classify patients into these subgroups that defined clinical risks. CONCLUSIONS: A distinct pattern of cytokine levels measured early in the course of sepsis predicts disease outcome. Subpopulations of patients have differing clinical outcomes that can be predicted accurately from

  5. Final infarct size measured by cardiovascular magnetic resonance in patients with ST elevation myocardial infarction predicts long-term clinical outcome

    DEFF Research Database (Denmark)

    Lønborg, Jacob Thomsen; Vejlstrup, Niels Grove; Kelbæk, Henning Skov;

    2013-01-01

    prognostic evaluation. To evaluate the prognostic importance of the final infarct size measured by cardiovascular magnetic resonance (CMR) in patients with STEMI. METHODS AND RESULTS: In an observational study the final infarct size was measured by late gadolinium enhancement CMR 3 months after initial...... admission in 309 patients with STEMI. The clinical endpoint was a composite of all-cause mortality and admission for heart failure. During the follow-up period of median 807 days (IQR: 669-1117) 35 events (5 non-cardiac deaths, 3 cardiac deaths, and 27 admissions for heart failure) were recorded. Patients...

  6. Correlation of Reconstructed Scaphoid Morphology with Clinical Outcomes

    Directory of Open Access Journals (Sweden)

    Ahmadreza Afshar

    2015-09-01

    Full Text Available Background: Scaphoid malunion alters the carpal kinematics and impairs clinical outcome because of pain, weakness, restricted range of motion and predisposing the wrist joint to early osteoarthritis. The aim of this study was to evaluate the influence of the scaphoid morphological angles on clinical outcomes in patients with reconstructed scaphoid by non-vascularized bone graft. Methods: Seventeen male patients with the mean age of 31.7±3.7 years and mean non-union time of 31.5±14.7 months were enrolled in this retrospective study. Average follow up was 48.8±9.4 months. At the last follow-up, the patients were evaluated clinically for pain, wrist range of motion, grip strength, and wrist functional status. They were also evaluated radiologically by wrist radiographs and computerized tomography (CT. The overall clinical outcomes were evaluated by the Cooney wrist function score. The morphology of the reconstructed scaphoids was evaluated by the lateral intrascaphoid angle, antroposterior intrascaphoid angle, dorsal cortical angle, measuring the length (mm, and height-to-length ratio on CT scan. The radiological measurements were compared against the overall clinical outcomes. Results: There were 7 excellent, 7 good, 3 fair clinical results. The mean Cooney wrist function score was 83±4. The mean lateral intrascaphoid angle was 34.8±1.4 degrees, mean antroposterior intrascaphoid angle was 33.4±2.2 degrees, mean dorsal cortical angle was 158.3±4.8 degrees, mean scaphoid length was 22.1± 0.7 mm, and mean scaphoid height-to-length ratio was 0.74±0.04. There were no significant statistical correlations between the lateral intrascaphoid angles, antroposterior intrascaphoid angles, dorsal cortical angles, scaphoid lengths and scaphoid height-to-length ratios and Cooney wrist scores in the patients. Conclusion: In the current study, all the patients had some degree of scaphoid malunion; however, the radiological measurements of the reconstructed

  7. 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.

  8. 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.

  9. 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. PMID:26579661

  10. Controlled outcome studies of child clinical hypnosis.

    Science.gov (United States)

    Adinolfi, Barbara; Gava, Nicoletta

    2013-08-01

    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. PMID:24165457

  11. 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.

  12. Scaphoid morphology and clinical outcomes in scaphoid reconstructions.

    Science.gov (United States)

    Megerle, K; Harenberg, P S; Germann, G; Hellmich, S

    2012-03-01

    Scaphoid malunion and carpal malalignment can result after scaphoid reconstruction, if the two fragments are not properly reduced before fixation. However, currently there is no information about which degree of deformity or malalignment can be tolerated without impairing clinical function. The purpose of this study was to investigate the influence of the scaphoid morphology and carpal alignment on clinical outcomes after scaphoid reconstruction. A total of 65 patients with an average age of 29 years were followed-up after a mean period of 45 months. In all patients, osseous union after a first-time scaphoid reconstruction in the middle third had been confirmed. Scapholunate (SL) and radiolunate (RL) angles were obtained on plain radiographs as were intrascaphoid (ISA) and dorsal cortical (DCA) angles and the height/length (H/L) ratio of the reconstructed scaphoid on computed tomography (CT) scans. These parameters were correlated with clinical outcome measures. RL angles correlated significantly with wrist range of motion, grip strength and pain levels, whilst SL angles, ISA, DCA and H/L ratio failed to show significant correlations. Our data suggest that clinical outcome is correlated with correct restoration of bone morphology and carpal alignment. After reconstruction, the RL angle should not exceed 10°. PMID:21903213

  13. Patient-reported outcomes in lupus clinical trials with biologics.

    Science.gov (United States)

    Annapureddy, N; Devilliers, H; Jolly, M

    2016-09-01

    Therapeutic advances in systemic lupus erythematosus (SLE) are greatly needed. Despite advances in our knowledge of pathogenesis of the disease and targets, treatment remains a significant challenge. Finding effective and relatively safe medications remains one of the top priorities. SLE significantly impairs quality of life (QoL), and patient-reported outcomes (PROs) measure a unique aspect of the disease not captured by disease activity. Inclusion of PRO measurements is encouraged in SLE clinical trials, as they allow capturing benefits of a proposed intervention in language patients can relate to and in areas deemed pertinent and important to and by patients. Availability of patient-reported and patient-centric clinical trials data may facilitate patients in informed and shared decision making, and allow for comparative cost-effectiveness evaluation for future resource allocation and reimbursements. Herein we review clinical trials with biologic therapies wherein PRO tools were included in the study design. PMID:27497256

  14. Clinical characteristics and outcomes in biclonal gammopathies.

    Science.gov (United States)

    Mullikin, Trey C; Rajkumar, S Vincent; Dispenzieri, Angela; Buadi, Francis K; Lacy, Martha Q; Lin, Yi; Dingli, David; Go, Ronald S; Hayman, Suzanne R; Zeldenrust, Steven R; Russell, Stephen J; Lust, John A; Leung, Nelson; Kapoor, Prashant; Kyle, Robert A; Gertz, Morie A; Kumar, Shaji K

    2016-05-01

    A single monoclonal protein typically characterizes monoclonal gammopathies, but a small proportion may have more than one M protein identifiable. In the setting of symptomatic multiple myeloma (MM), the development of a new monoclonal protein following therapy is associated with better outcomes. As for the precursor conditions, monoclonal gammopathy undetermined significance (MGUS) and smoldering multiple myeloma (SMM), there is limited information on the impact of a second monoclonal protein on the disease course, including progression and response to treatment. The outcomes of patients with MGUS and SMM with more than one monoclonal protein, after identifying 539 patients with biclonal proteins on electrophoresis and/or immunofixation, were reported. About 22 of 393 patients with MGUS/biclonal gammopathy of undetermined significance (BGUS) progressed to SMM (6), MM (11), AL (3), or WM (2), and 5 of 16 patients with biclonal SMM progressed to MM. The rate of progression for BGUS was approximately 1% per year, which is similar to MGUS with one monoclonal protein. The median estimated time of progression of biclonal SMM was 2.6 years; similar to monoclonal SMM. For patients with biclonal MM, both M spikes responded to treatment and, upon relapse, the original dominant M protein remained dominant as the disease progressed. In conclusion, the presence of a second monoclonal protein does not appear to affect the progression of precursor states and suggests multiple monoclonal proteins do not clinically impact one another in the course of the disease. Am. J. Hematol. 91:473-475, 2016. © 2016 Wiley Periodicals, Inc. PMID:26840395

  15. 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

  16. Measuring Inclusive Education Outcomes in Alberta, Canada

    Science.gov (United States)

    Loreman, Tim

    2014-01-01

    This study details the results of a review of the academic and public sector literature on measuring inclusive education in large systems. It highlights some outcomes drawn from the international literature on inclusion that might be indicative of the presence and quality of inclusive education in an effort to develop a set of outcomes for…

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

    International Nuclear Information System (INIS)

    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

  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. 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...

  20. 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.

  1. Physician outcome measurement: review and proposed model.

    Science.gov (United States)

    Siha, S

    1998-01-01

    As health care moves from a free-for-service environment to a capitated arena, outcome measurements must change. ABC Children's Medical Center is challenged with developing comprehensive outcome measures for an employed physician group. An extensive literature review validates that physician outcomes must move beyond revenue production and measure all aspects of care delivery. The proposed measurement model for this physician group is a trilogy model. It includes measures of cost, quality, and service. While these measures can be examined separately, it is imperative to understand their integration in determining an organization's competitive advantage. The recommended measurements for the physician group must be consistent with the overall organizational goals. The long-term impact will be better utilization of resources. This will result in the most cost effective, quality care for the health care consumer. PMID:10339092

  2. Ebola outbreak in Conakry, Guinea: Epidemiological, clinical, and outcome features

    OpenAIRE

    Barry, M; Traoré, F A; Sako, F B; Kpamy, D O; Bah, E I; Poncin, M; S. Keita; Cisse, M; Touré, A.

    2014-01-01

    The authors studied the epidemiological, clinical, and outcome features of the Ebola virus disease in patients hospitalized at the Ebola treatment center (ETC) in Conakry to identify clinical factors associated with death.

  3. 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

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

    DEFF Research Database (Denmark)

    1998-01-01

    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 the...

  5. Childhood Pars Planitis; Clinical Features and Outcomes

    Directory of Open Access Journals (Sweden)

    Homayoon Nikkhah

    2011-01-01

    Full Text Available Purpose: To evaluate the demographic and clinical features of childhood pars planitis, and to determine the therapeutic and visual outcomes of the disease. Methods: Medical records of pediatric patients (less than 16 years of age at diagnosis with pars planitis and at least 6 months of follow-up who were referred to Labbafinejad Medical Center, Tehran, Iran over a 22 year period were reviewed. Results: Overall, 117 eyes of 61 patients including 51 (83.6% male subjects were included. Mean age at the time of diagnosis was 7.8΁3.2 (range, 3-16 years. Mean best corrected visual acuity (BCVA was 0.88΁0.76 logMAR at presentation which improved to 0.39΁0.51 logMAR at final visit (P<0.001. Endotheliitis was present in 23 (19.6% eyes and was significantly more prevalent in subjects younger than 9 years (P=0.025. Cataract formation (41.9% and cystoid macular edema (19.7% were the most prevalent complications. Univariate regression analysis showed that better baseline visual acuity (OR=0.38, 95%CI 0.21-0.70, P=0.002, age older than 5 years at disease onset (OR=0.36, 95%CI 0.14-0.9, P=0.029, absence of endotheliitis (OR=0.39, 95%CI 0.15-0.99, P=0.047 and female gender (OR=3.77, 95%CI 1.03-13.93, P=0.046 were significantly associated with final BCVA of 20/40 or better. Conclusion: Childhood pars planitis was much more common among male subjects. Endotheliitis may be a sign of inflammation spillover and is more prevalent in younger patients. Visual prognosis is favorable in most patients with appropriate treatment.

  6. Bone scintigraphy and clinical outcome in rheumatoid gonarthritis

    International Nuclear Information System (INIS)

    Aim: For evaluation of the effect of radiosynoviorthesis (RSO) on the early and delayed uptake of 99mTc-biphosphonates and its relation to clinical outcome we studied these variables before and after radiosynoviorthesis performed on 41 knees affected by rheumatoid arthritis. Method: Thirty-seven patients with rheumatoid gonarthritis were treated by intraarticular injection with 185 MBq yttrium-90 citrate. In four of them both knees were treated so that 41 therapies were evaluated. On the average 35 days before and 120 days after radiosynoviorthesis, the early and delayed uptake of 99mTc-diphosphonate (DPD) was measured with a planar gamma camera. Early and late DPD uptake was quantified as a ratio between count values derived from rectangular ROIs placed on the knee treated and on the ipsilateral thigh. The severity of clinical symptoms was assessed on two 3-point rating scales averaged. Results: 30 of the 41 cases favorably responded to radiosynoviorthesis. There was a significant correlation between clinical outcomeand pretherapeutic early DPD uptake (EDU) (p0.05). In 25 of the 30 responders EDU decreased; EDU increased or remained constant in five of the eleven non-responders. The correlation between outcome and the difference in EDU was significant (r = 0.344; p<0.05). There was no such significant relationship between the difference between pre- and posttherapeutic DDU and clinical course. Conclusion: Three-phase bone scintigraphy may contribute to predict and assess the success of radiosynoviorthesis in rheumatoid arthritis of the knee joint. (orig.)

  7. Clinical and Outcome Research in oncology The need for integration

    Directory of Open Access Journals (Sweden)

    Apolone Giovanni

    2003-04-01

    Full Text Available Abstract Cancer is one of the main healthcare problems in Europe. Although significant progress has recently been made, long-term survival is still disappointing for most common solid tumours. The explosion of information has strengthened the need to create and sustain coordinated interaction between technology, biology, clinical research, clinical practice and health policy. A simple process based on automatic and passive translation from bench to clinical research and eventually to the bed side is usually assumed but cannot be taken for granted. A critical role might be played by Outcome Research (OR, defined as the discipline that describes, interprets, and predicts the impact of various influences, especially interventions, on final endpoints (from survival to satisfaction with care that matter to decision makers (from patients to society at large, with special emphasis on the use of patient-reported outcomes (PRO. Recently, under pressure from several parts of society, the FDA, recognizing the need for faster drug approval, has modified existing regulations and created new rules to allow anti-cancer drugs to be approved more quickly and, in certain but quite common circumstances, single arm trials and surrogate endpoints to be used as measures of clinical benefit. In this context, the faster approval process may lead to drugs being marketed without there being a complete picture of how effective or safe they are. The FDA move to speed up drug approval, together with the use of not fully validated surrogate endpoints, give OR the unique opportunity to help understand the value of drugs that have received accelerated approval. Despite this opportunity, OR has yet to demonstrate its role in this specific setting and provide proof of the validity, reliability and added value of its primary endpoint measures when evaluated in a broader context. The implementation of lines of OR in the development and evaluation of anti-cancer drugs hinges upon

  8. Exploring the Implementation and Use of Outcome Measurement in Practice: A Qualitative Study

    Science.gov (United States)

    Skeat, J.; Perry, A.

    2008-01-01

    Background: Outcome measurement is important to clinical practice--yet outcome many speech and language therapists find it difficult to apply measures in practice, and not all clinicians and services have been able to implement and/or use outcome measurement successfully. To date there has been little research to explain why implementation is…

  9. Subjective and objective outcomes in randomized clinical trials

    DEFF Research Database (Denmark)

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

    2014-01-01

    OBJECTIVES: The degree of bias in randomized clinical trials varies depending on whether the outcome is subjective or objective. Assessment of the risk of bias in a clinical trial will therefore often involve categorization of the type of outcome. Our primary aim was to examine how the concepts...... explicitly defined the terms. CONCLUSION: The terms "subjective" and "objective" are ambiguous when used to describe outcomes in randomized clinical trials. We suggest that the terms should be defined explicitly when used in connection with the assessment of risk of bias in a clinical trial...

  10. 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...

  11. 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

  12. Measuring Gambling Outcomes Among College Students

    OpenAIRE

    Neighbors, Clayton; Lostutter, Ty W.; Larimer, Mary E.; Takushi, Ruby Y.

    2002-01-01

    The present research describes the proposal and validation of three gambling outcome measures, the Gambling Quantity and Perceived Norms Scale (GQPN), the Gambling Problem Index (GPI), and the Gambling Readiness to Change Questionnaire (GRTC). The study consisted of 560 undergraduate college students who completed a survey including the newly constructed measures and other measures designed to assess convergent validity. Results confirmed good reliability and convergent validity of all three ...

  13. 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. PMID:27089522

  14. 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

    2015年10月21日,《中国医疗设备》杂志社独家承办了“第一届国际临床工程与医疗技术管理大会”(ICEHTMC 2015),大会主席由美国FDA医疗设备顾问委员会主席、美国临床医学工程学会主席Yadin David先生和301医院周丹主任共同担任。来自14个国家的临床医学工程学会的主席、23个国家的60多位医学工程的领军人物、世界卫生组织医疗器械委员会的协调员及国内580多医工专家与会交流,共同搭建世界临床医学工程的学术平台。%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

  15. 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

  16. Testing Multiple Outcomes in Repeated Measures Designs

    Science.gov (United States)

    Lix, Lisa M.; Sajobi, Tolulope

    2010-01-01

    This study investigates procedures for controlling the familywise error rate (FWR) when testing hypotheses about multiple, correlated outcome variables in repeated measures (RM) designs. A content analysis of RM research articles published in 4 psychology journals revealed that 3 quarters of studies tested hypotheses about 2 or more outcome…

  17. Measuring participation outcomes in rehabilitation medicine

    OpenAIRE

    Zee, C.H. van der

    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 both objective and subjective participation. The reproducibility of the USER-Participation was assessed in the heterogeneous sample, with generally satisfactory results. ICC values were good for the ...

  18. 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......, (2) assess the need for de-learning existing knowledge (i.e., cleaning the slate), and (3) being able to set up challenging yet fair exams for the total student body. This paper extends prior research on the role of declarative and procedural knowledge in performing auditing tasks. Measuring learning...

  19. Treatment Outcome Package: Measuring and facilitating multidimensional change.

    Science.gov (United States)

    Boswell, James F; Kraus, David R; Castonguay, Louis G; Youn, Soo Jeong

    2015-12-01

    The Treatment Outcome Package (TOP; D. R. Kraus, Seligman, & Jordan, 2005) is a multidimensional routine progress and outcome measure developed for use in diverse naturalistic practice settings. In this article, we (a) provide a brief review and summary of the extant psychometric and research support for the TOP, (b) provide examples of the TOP's use in clinical training and practice, and (c) discuss the implications of the TOP for future psychotherapy training, research, and practice. In particular, we focus on the implications of risk-adjusted progress monitoring for systems of care and mental health care decision making. PMID:26641372

  20. 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.

  1. Admissions to acute adolescent psychiatric units: a prospective study of clinical severity and outcome

    OpenAIRE

    Jensen Gunnar; Hatling Trond; Heyerdahl Sonja; Hanssen-Bauer Ketil; Olstad Pål; Stangeland Tormod; Tinderholt Tarje

    2011-01-01

    Abstract Background Several countries have established or are planning acute psychiatric in-patient services that accept around-the-clock emergency admission of adolescents. Our aim was to investigate the characteristics and clinical outcomes of a cohort of patients at four Norwegian units. Methods We used a prospective pre-post observational design. Four units implemented a clinician-rated outcome measure, the Health of the Nation Outcome Scales for Children and Adolescents (HoNOSCA), which ...

  2. The Self-Assessment of Role-Performance and Activities of Daily Living Abilities (SARA™): Development and Clinical Utility of a Client-Centered Screening Tool and Outcome Measure.

    Science.gov (United States)

    Watkins, Sarah L; Lounsbury, Peggy A; Fleming-Castaldy, Rita P

    2016-01-01

    This article describes the development and use of the Self-Assessment of Role-performance and activities of daily living Abilities (SARA™), a standardized client-centered index of functional abilities. Developed in four phases, this article describes the initial development, pilot testing and revision, examination of psychometric properties, and finalization. Pilot studies found the SARA™ to be reliable, valid, and responsive to change. The use of the SARA™ in clinical practice and for outcome monitoring promotes client-centered goal setting and client-valued rehabilitation. It is a viable alternative to deficit-focused measures. The SARA™ is a promising new tool that warrants increased utilization and further research. PMID:26115016

  3. A model to begin to use clinical outcomes in medical education.

    Science.gov (United States)

    Haan, Constance K; Edwards, Fred H; Poole, Betty; Godley, Melissa; Genuardi, Frank J; Zenni, Elisa A

    2008-06-01

    The latest phase of the Accreditation Council for Graduate Medical Education (ACGME) Outcome Project challenges graduate medical education (GME) programs to select meaningful clinical quality indicators by which to measure trainee performance and progress, as well as to assess and improve educational effectiveness of programs. The authors describe efforts to measure educational quality, incorporating measurable patient-care outcomes to guide improvement. University of Florida College of Medicine-Jacksonville education leaders developed a tiered framework for selecting clinical indicators whose outcomes would illustrate integration of the ACGME competencies and their assessment with learning and clinical care. In order of preference, indicators selected should align with a specialty's (1) national benchmarked consensus standards, (2) national specialty society standards, (3) standards of local, institutional, or regional quality initiatives, or (4) top-priority diagnostic and/or therapeutic categories for the specialty, based on areas of high frequency, impact, or cost. All programs successfully applied the tiered process to clinical indicator selection and then identified data sources to track clinical outcomes. Using clinical outcomes in resident evaluation assesses the resident's performance as reflective of his or her participation in the health care delivery team. Programmatic improvements are driven by clinical outcomes that are shown to be below benchmark across the residents. Selecting appropriate clinical indicators-representative of quality of care and of graduate medical education-is the first step toward tracking educational outcomes using clinical data as the basis for evaluation and improvement. This effort is an important aspect of orienting trainees to using data for monitoring and improving care processes and outcomes throughout their careers. PMID:18520464

  4. 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.

  5. A Five-Phase Model for Clinical-Outcome Research

    Science.gov (United States)

    Robey, Randall R.

    2004-01-01

    Through a variety of approaches, speech-language pathologists and audiologists have produced strong evidence that treatments are generally potent. However, we have largely ignored the accepted standards for clinical-outcome testing used throughout the broader research community (e.g., by other clinical disciplines, federal regulators, and…

  6. Clinical Features and Outcome of Mucormycosis

    OpenAIRE

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

    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...

  7. Clinical outcomes of enjoying sexualization among lesbian women.

    Science.gov (United States)

    Erchull, Mindy J; Liss, Miriam

    2015-01-01

    The Enjoyment of Sexualization Scale (ESS) was given to 150 lesbians in addition to measures of self-objectification, negative eating attitudes, and depression. The ESS was found to have acceptable levels of internal consistency reliability with a lesbian sample. Scores on the ESS were lower in this sample than in previously reported research with heterosexual women. Enjoying sexualization was found to moderate the relationship between body shame and both depressive symptomatology and negative eating attitudes. In contrast to findings from a heterosexual sample, lesbians who enjoyed sexualization had smaller relationships between these negative clinical outcomes and body shame than lesbians who did not. For lesbians, enjoying sexualization may serve a protective function against the negative effects of self-objectification. Findings are discussed in terms of body image and perceptions of ideal beauty among lesbians. PMID:25287134

  8. Smoking status influences clinical outcome in collagenous colitis

    DEFF Research Database (Denmark)

    Andreas, Munch; Curt, Tysk; Johan, Bohr; Ahmed, Madisch; Bonderup, Ole Kristian; Ralf, Mohrbacher; Ralph, Mueller; Roland, Greinwald; Magnus, Ström; Stephan, Miehlke

    2015-01-01

    BACKGROUND: The relationship between clinical and histological parameters in collagenous colitis (CC) is poorly understood. Smoking is a risk factor for CC, whereas its impact on clinical activity and outcome is not well-known. METHODS: In a post-hoc analysis from pooled data of two randomized...... collagen band, inflammation of the lamina propria, total numbers of intraepithelial lymphocytes, degeneration). Moreover, we analyzed the predictive value of baseline parameters on clinical outcome in a logistic regression model. RESULTS: Pooled data from 202 patients with active CC were available thereof...

  9. Nutrition and Chronic Wounds: Improving Clinical Outcomes.

    Science.gov (United States)

    Molnar, Joseph A; Vlad, Lucian G; Gumus, Tuna

    2016-09-01

    There is increasing awareness that chronic wound healing is very dependent on the patient's nutritional status, but there are no clearly established and accepted assessment protocols or interventions in clinical practice. Much of the data used as guidelines for chronic wound patients are extrapolated from acutely wounded trauma patients, but the 2 groups are very different patient populations. While most trauma patients are young, healthy, and well-nourished before injury, the chronic wound patient is usually old, with comorbidities and frequently malnourished. We suggest the assumption that all geriatric wound patients are malnourished until proved otherwise. Evaluation should include complete history and physical and a formal nutritional evaluation should be obtained. Laboratory studies can be used in conjunction with this clinical information to confirm the assessment. While extensive studies are available in relation to prevention and treatment of pressure ulcers and perioperative nutrition, less is known of the effect of nutritional deficits and supplementation of the diabetic foot ulcer and venous stasis ulcer patient. This does not necessarily mean that nutritional support of these patients is not helpful. In the pursuit of wound healing, we provide systemic support of cardiac and pulmonary function and cessation of smoking, improve vascular inflow, improve venous outflow, decrease edema, and treat with hyperbaric oxygen. If we address all of these other conditions, why would we not wish to support the most basic of organismal needs in the form of nutrition? PMID:27556777

  10. Clinical outcome of endonasal KTP laser assisted dacryocystorhinostomy

    Directory of Open Access Journals (Sweden)

    Carrie Sean

    2005-03-01

    Full Text Available Abstract Background To evaluate the clinical outcome of primary endonasal laser assisted dacryocystorhinostomy (ENL-DCR using the potassium-titanyl-phosphate laser. Methods We retrospectively reviewed all primary ENL-DCRs performed within a period of twelve months by the same combined Ophthalmology and Otorhinolaringology team in Freeman Hospital, Newcastle upon Tyne, UK. The main outcome measure for success was resolution or significant improvement of epiphora. Details of surgery, intraoperative and postoperative complications, as well as pathology associated with failure were also studied. Patients were followed up for at least 12 months. Results A total of 41 consecutive ENL-DCRs on 29 patients (22 females, 7 males, mean age 75 years were analysed. All patients had bicanalicular silicone intubation for at least 4 months. The success rate at 12 months postoperatively was 78.1%. Pathology associated with failure included: intranasal pathology (12.2%, mucocele (7.3%, and systemic sarcoidosis (2.4%. No significant intra-operative complications were recorded. Conclusion The ENL-DCR with potassium-titanyl-phosphate laser can be considered as a safe and efficient primary procedure for the treatment of nasolacrimal duct obstruction.

  11. Predictors of clinical outcome following lumbar disc surgery

    DEFF Research Database (Denmark)

    Hebert, Jeffrey J; Fritz, Julie; Koppenhaver, S.L.;

    2016-01-01

    PURPOSE: Explore the relationships between preoperative findings and clinical outcome following lumbar disc surgery, and investigate the prognostic value of physical examination findings after accounting for information acquired from the clinical history. METHODS: We recruited 55 adult patients...... of leg pain to LBP, pain medication use, greater time to surgery, and no history of previous physical or injection therapy. Physical examination predictors were a positive straight or cross straight leg raise test, diminished lower extremity strength, sensation or reflexes, and the presence of...... outcome. CONCLUSIONS: Information gleaned from the clinical history and physical examination helps to identify patients more likely to succeed with lumbar disc surgery. While this study helps to inform clinical practice, additional research confirming these results is required prior to confident clinical...

  12. Bioplastique at 6 years: clinical outcome studies.

    Science.gov (United States)

    Ersek, R A; Gregory, S R; Salisbury, A V

    1997-11-01

    Bioplastique is a biphasic polymer for the permanent augmentation of some soft tissues. It was developed in 1987, and clinical studies at this institution were begun in 1990. The combination of low molecular weight polyvinylpyrrolidone and solid polymer particles allows the implantation of permanent polymer spheres through a small needle under local anesthesia. In this study 127 cases are reviewed of consecutive patients who have received Bioplastique for scar revision, wrinkles, and augmentation for soft-tissue defects at 6 years after application. All patients who had not been in for follow-up recently were contacted by mail and questioned on the permanence of augmentation and migration of particles. About 30 percent of the patients were unreachable and had their charts reviewed for permanence and migration of particles. In eight of these cases, Bioplastique was removed because of overcorrection, two of them may have had infection. Bioplastique has gained wide use throughout the world and although some complications have been reported, in general, it functions quite well when used in selected cases. PMID:9385974

  13. Clinical Features and Outcomes of Takotsubo (Stress) Cardiomyopathy

    OpenAIRE

    Templin, Christian; Ghadri, J R; Diekmann, J.; Napp, L C; Seifert, Burkhardt; et al

    2015-01-01

    BACKGROUND The natural history, management, and outcome of takotsubo (stress) cardiomyopathy are incompletely understood. METHODS The International Takotsubo Registry, a consortium of 26 centers in Europe and the United States, was established to investigate clinical features, prognostic predictors, and outcome of takotsubo cardiomyopathy. Patients were compared with age- and sex-matched patients who had an acute coronary syndrome. RESULTS Of 1750 patients with takotsubo cardiomyopathy, ...

  14. 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

  15. Outcome-Driven Thresholds for Home Blood Pressure Measurement International Database of HOme blood pressure in relation to Cardiovascular Outcome

    OpenAIRE

    Niiranen, T. J.; Asayama, K.; Thijs, L; Johansson, J K; Ohkubo, T.; Kikuya, M; Boggia, J.; Hozawa, A.; Sandoya, E.; Stergiou, G. S.; Tsuji, I; Jula, A. M.; Imai, Y.; Staessen, J. A.

    2013-01-01

    The lack of outcome-driven operational thresholds limits the clinical application of home blood pressure (BP) measurement. Our objective was to determine an outcome-driven reference frame for home BP measurement. We measured home and clinic BP in 6470 participants (mean age, 59.3 years; 56.9% women; 22.4% on antihypertensive treatment) recruited in Ohasama, Japan (n=2520); Montevideo, Uruguay (n=399); Tsurugaya, Japan (n=811); Didima, Greece (n=665); and nationwide in Finland (n=2075). In mul...

  16. Centralization of Esophageal Cancer Surgery: Does It Improve Clinical Outcome?

    NARCIS (Netherlands)

    M.W.J.M. Wouters (Michael); H.E. Karim-Kos (Henrike); S. le Cessie (Saskia); B.P.L. Wijnhoven (Bas); L.P. Stassen; W.H. Steup (Willem Hans); H.W. Tilanus (Hugo); R.A.E.M. Tollenaar (Rob)

    2009-01-01

    textabstractBackground: The volume-outcome relationship for complex surgical procedures has been extensively studied. Most studies are based on administrative data and use in-hospital mortality as the sole outcome measure. It is still unknown if concentration of these procedures leads to improvement

  17. Measurement of Outcomes of Upper Limb Reconstructive Surgery for Tetraplegia.

    Science.gov (United States)

    Sinnott, K Anne; Dunn, Jennifer A; Wangdell, Johanna; Johanson, M Elise; Hall, Andrew S; Post, Marcel W

    2016-06-01

    Reconstructive arm/hand surgery for tetraplegia is performed to improve arm/hand function and therefore personal well-being for individuals who accept such elective surgeries. However, changes at an impairment level do not always translate into functional or quality of life changes. Therefore, multiple outcome tools should be used that incorporate sufficient responsiveness to detect changes in arm/hand function, activity and participation, and quality of life of the individuals involved. This narrative review aims to assist clinicians to choose the most appropriate tools to assess the need for reconstructive surgery and to evaluate its outcomes. Our specific objectives are (1) to describe aspects to consider when choosing a measure and (2) to describe the measures advised by an international therapist consensus group established in 2007. All advised measures are appraised in terms of the underlying construct, administration, and clinical relevance to arm/hand reconstructions. Essentially there are currently no criterion standard measures to evaluate the consequences of reconstructive arm/hand surgery. However, with judicious use of available measures it is possible to ensure the questions asked or tasks completed are relevant to the surgical reconstruction(s) undertaken. Further work in this field is required. This would be best met by immediate collaboration between 2 outcome's tool developers and by analysis of pre- and postoperative data already held in various international sites, which would allow further evaluation of the measures already in use, or components thereof. PMID:27233592

  18. Survival and clinical outcome of dogs with ischaemic stroke

    DEFF Research Database (Denmark)

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

    2013-01-01

    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...... in terms of survival and clinical outcome. However, owners should be informed of the risk of acute death within 30days and of the possibility of new neurological events in survivors. Mortality was increased in dogs with right-sided lesions in this study....

  19. Correlation of Reconstructed Scaphoid Morphology with Clinical Outcomes

    OpenAIRE

    Ahmadreza Afshar; Afshin Mohammadi; Kian Zohrabi; Nasrin Navaeifar; Sam Sami; Hassan Taleb

    2015-01-01

    Background: Scaphoid malunion alters the carpal kinematics and impairs clinical outcome because of pain, weakness, restricted range of motion and predisposing the wrist joint to early osteoarthritis. The aim of this study was to evaluate the influence of the scaphoid morphological angles on clinical outcomes in patients with reconstructed scaphoid by non-vascularized bone graft. Methods: Seventeen male patients with the mean age of 31.7±3.7 years and mean non-union time of 31.5±14.7 months we...

  20. Hepatology may have problems with putative surrogate outcome measures

    DEFF Research Database (Denmark)

    Gluud, Christian; Brok, Jesper; Gong, Yan;

    2007-01-01

    faster or more often, are cheaper, and/or are less invasively achieved than the clinical outcome. In practice, validation is surprisingly often overlooked, especially if a biologic plausible rationale is proposed. Surrogate outcomes must be validated before use. The first step in validation is to...... predicts the intervention's effect on the clinical outcome. In hepatology a number of putative surrogate outcomes are used both in clinical research and in clinical practice without having been properly validated. Sustained virological response to interferons and ribavirin in patients with chronic...

  1. Short Term Clinical Outcome of Percutaneous Vertebroplasty

    Directory of Open Access Journals (Sweden)

    Masoud Nemati

    2009-01-01

    Full Text Available "nIntroduction: The first case of percutaneous vertebroplasty (PV was performed by French radiologists in 1984 for the treatment of vertebral hemangioma. Nowadays this procedure is useful in the treatment of osteoporotic compression fracures, hemangiomas, osteolytic metastasis and vertebral involvement by multiple myeloma. We carried out this study to clarify the short term results of PV in reducing the pain and disabilities of these patients. "nMaterials and Methods: From September 2008 to December 2008, 20 patients with compression fracture, hemangioma and metastasis to the lumbar vertebral bodies underwent PV and short term postprocedural results were studied by Visual Analogue Scale (VAS and Oswestry Low Back Pain Disability Questionnaire (Oswestry LBPDQ and the results were compared with preprocedural measurements. "nResults: Comparison of pre and postprocedural VAS and Oswestry LBPDQ, showed a statistically meaningful decrease in pain intensity and improvement in functional ability of these patients post PV. No other significant side effect was detected. "nConclusion: PV is safe and effective in the treatment of vertebral compression fractures in the above mentioned groups. "nKeywords: Percutaneous Vertebroplasty (PV, Visual Analogue Scale (VAS, Oswestry Low Back Pain, Diasability Questionnaire  

  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). PMID:26306284

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

    DEFF Research Database (Denmark)

    Nielsen, Anette Søgaard; Nielsen, Bent

    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...

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

    OpenAIRE

    Estanol Bruno; Salinas Vicente; Hernández-Ronquillo Lizbeth; Téllez-Zenteno José F; da Silva Orlando

    2004-01-01

    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 myasth...

  5. Multisystemic Therapy(®) : Clinical Overview, Outcomes, and Implementation Research.

    Science.gov (United States)

    Henggeler, Scott W; Schaeffer, Cindy M

    2016-09-01

    Multisystemic therapy (MST) is an evidence-based treatment originally developed for youth with serious antisocial behavior who are at high risk for out-of-home placement and their families; and subsequently adapted to address other challenging clinical problems experience by youths and their families. The social-ecological theoretical framework of MST is presented as well as its home-based model of treatment delivery, defining clinical intervention strategies, and ongoing quality assurance/quality improvement system. With more than 100 peer-reviewed outcome and implementation journal articles published as of January 2016, the majority by independent investigators, MST is one of the most extensively evaluated family based treatments. Outcome research has yielded almost uniformly favorable results for youths and families, and implementation research has demonstrated the importance of treatment and program fidelity in achieving such outcomes. PMID:27370172

  6. 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.

  7. 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

  8. 42 CFR 410.146 - Diabetes outcome measurements.

    Science.gov (United States)

    2010-10-01

    ... 42 Public Health 2 2010-10-01 2010-10-01 false Diabetes outcome measurements. 410.146 Section 410.146 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES... Training and Diabetes Outcome Measurements § 410.146 Diabetes outcome measurements. (a)...

  9. Clinical outcome research in complementary and alternative medicine: an overview of experimental design and analysis.

    Science.gov (United States)

    Gatchel, R J; Maddrey, A M

    1998-09-01

    This article serves as a primer for those beginning clinical research in complementary and alternative medicine. The authors provide a basic overview of important experimental design and statistical issues, of which clinical researchers in the area of complementary and alternative medicine must be aware when attempting to demonstrate the effectiveness of particular treatment modalities. As the article suggests, science is an inferential process, and experimental investigations can vary greatly in methodological integrity. Key concepts in clinical outcome research such as internal validity, statistical conclusion validity, and the appropriate measurement and operational definitions of outcomes are discussed. New scientific approaches that are evolving because of paradigm shifts in science (e.g., chaos theory) are also reviewed. Suggestions are provided to further develop an understanding of clinical outcome research methodology. PMID:9737030

  10. Activated partial thromboplastin time measurement is not associated with clinical outcomes in patients with high-risk non-ST-segment elevation acute coronary syndromes treated with unfractionated heparin.

    Science.gov (United States)

    Thomas, Michael P; Mahaffey, Kenneth W; Chiswell, Karen; Cohen, Marc; Kontos, Michael C; Antman, Elliott M; Ferguson, James J; Califf, Robert M; Goodman, Shaun G; Becker, Richard C

    2012-07-01

    Our objective was to determine the association of activated partial thromboplastin time (aPTT) with recurrent ischemic events and non-coronary artery bypass surgery-related thrombolysis in myocardial infarction major bleeding. We studied 4,985 patients with high-risk non-ST-segment elevation acute coronary syndromes (NSTE ACS) participating in SYNERGY, a prospective, randomized, international trial designed to emulate contemporary practice wherein unfractionated heparin (UFH) is given intravenously and titrated according to a weight-adjusted dosing nomogram to a target aPTT of 1.5-2 times the upper limit of normal (approximately 50-70 s). Aspirin was administered to 95% of patients, clopidogrel to 63%, and glycoprotein IIb/IIIa receptor inhibitors to 58%. More than 90% of patients underwent early coronary angiography, and 69% were revascularized. Used as a time-dependent covariate, aPTT was evaluated as a predictor of time to ischemic or major hemorrhagic events in proportional hazards regression models. Using discrete variable analysis, aPTT was categorized as persistently below a lower threshold of anticoagulation (70 vs. ≤70 s) for major hemorrhagic events. UFH treatment lasted a median of 42 (30, 78) h. At >6-12 (n = 3,021), >12-24 (n = 3,406), and >24-48 (n = 2,497) h, 34, 41, and 46% of patients achieved the target aPTT range, respectively. Both before and after adjusting for baseline predictors of anticoagulant response and risk score (age, hypertension, diabetes, smoking, ST depression, and renal function), no significant relationship between aPTT values and recurrent ischemic events or major bleeding was found. No relationship was observed between clinical outcomes and aPTT values persistently above or below the designated thresholds. Measurements of aPTT were not associated with clinical outcomes among patients with NSTE ACS treated with UFH. The required intensity of anticoagulation for benefit may be relatively modest when UFH is administered

  11. Neurocognitive clinical outcome assessments for inborn errors of metabolism and other rare conditions.

    Science.gov (United States)

    Shapiro, Elsa; Bernstein, Jessica; Adams, Heather R; Barbier, Ann J; Buracchio, Teresa; Como, Peter; Delaney, Kathleen A; Eichler, Florian; Goldsmith, Jonathan C; Hogan, Melissa; Kovacs, Sarrit; Mink, Jonathan W; Odenkirchen, Joanne; Parisi, Melissa A; Skrinar, Alison; Waisbren, Susan E; Mulberg, Andrew E

    2016-06-01

    Well-defined and reliable clinical outcome assessments are essential for determining whether a drug provides clinically meaningful treatment benefit for patients. In 2015, FDA convened a workshop, "Assessing Neurocognitive Outcomes in Inborn Errors of Metabolism." Topics covered included special challenges of clinical studies of inborn errors of metabolism (IEMs) and other rare diseases; complexities of identifying treatment effects in the context of the dynamic processes of child development and disease progression; and the importance of natural history studies. Clinicians, parents/caregivers, and participants from industry, academia, and government discussed factors to consider when developing measures to assess treatment outcomes, as well as tools and methods that may contribute to standardizing measures. Many issues examined are relevant to the broader field of rare diseases in addition to specifics of IEMs. PMID:27132782

  12. Standardized Outcome Measurement for Patients With Coronary Artery Disease: Consensus From the International Consortium for Health Outcomes Measurement (ICHOM)

    OpenAIRE

    McNamara, Robert L.; Spatz, Erica S.; Kelley, Thomas A; Stowell, Caleb J; Beltrame, John; Heidenreich, Paul; Tresserras, Ricard; Jernberg, Tomas; Chua, Terrance; Morgan, Louise; Panigrahi, Bishnu; Rosas Ruiz, Alba; Rumsfeld, John S.; Sadwin, Lawrence; Schoeberl, Mark

    2015-01-01

    Background: Coronary artery disease (CAD) outcomes consistently improve when they are routinely measured and provided back to physicians and hospitals. However, few centers around the world systematically track outcomes, and no global standards exist. Furthermore, patient-centered outcomes and longitudinal outcomes are under-represented in current assessments. Methods and Results: The nonprofit International Consortium for Health Outcomes Measurement (ICHOM) convened an international Working ...

  13. Beyond the Basics of Clinical Outcomes Assessment: Selecting Appropriate Patient-Rated Outcomes Instruments for Patient Care

    Science.gov (United States)

    Valier, Alison R.; Lam, Kenneth C.

    2015-01-01

    The fifth edition of the "Athletic Training Education Competencies" emphasizes the concepts of clinical outcomes assessment. In athletic training, clinical outcomes assessment, especially as it relates to patient-rated outcomes (PRO) instruments, is new, which produces uncertainty with regard to how to integrate PROs into athletic…

  14. 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...... ejection fractions and similar changes in ventricular volumes from baseline to 1 month and 20 months. CONCLUSIONS: In VALIANT, the risk of HF following MI was higher in women than men after adjusting for age and comorbidities, although the risk of other fatal and non-fatal outcomes were similar. The higher...

  15. Clinical Concerns About Clinical Performance Measurement

    OpenAIRE

    Werner, Rachel M.; Asch, David A.

    2007-01-01

    Performance measurement has become one of the foundations of current efforts to improve health care quality and has successfully increased compliance with practice guidelines in many settings. Despite the successes of performance measurement, many physicians remain apprehensive about its use because performance measurement “gets in the way of” delivering good care. There are several reasons clinicians might feel this way. First, performance measurement is increasingly being extended to areas ...

  16. 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.

  17. Factors influencing outcomes of clinical information systems implementation: a systematic review.

    Science.gov (United States)

    Gruber, Dianne; Cummings, Greta G; LeBlanc, Lisa; Smith, Donna L

    2009-01-01

    Healthcare agencies spend significant resources to acquire or develop clinical information systems. However, implementation of clinical information systems often report significant failures. A systematic review of the research literature identified processes and outcomes of clinical information system implementation and factors that influenced success or failure. Of 124 original papers, 18 met the primary inclusion criteria-clinical systems implementation, healthcare facility, and outcome measures. Data extraction elements included study characteristics, outcomes, and implementation risk factors classified according to the Expanded Systems Life Cycle. The quality of each study was also assessed. Forty-nine outcomes of clinical information system implementation were identified. No single implementation strategy proved completely effective. The findings of this synthesis direct the attention of managers and decision makers to the importance of clinical context to successful implementation of clinical information systems. The highest number of factors influencing success or failure was reported during implementation and system "go-live." End-user support or lack thereof was the important factor in both successful and failed implementations, respectively. Following the Expanded Systems Life Cycle management model instead of a traditional project management approach may contribute to greater success over time, by paying particular attention to the underrecognized maintenance phase of implementation. PMID:19411944

  18. Association of Postburn Fatty Acids and Triglycerides with Clinical Outcome in Severely Burned Children

    Science.gov (United States)

    Kraft, Robert; Herndon, David N.; Finnerty, Celeste C.; Hiyama, Yaeko

    2013-01-01

    Context: Free fatty acids (FFAs) and triglycerides (TGs) are altered postburn, but whether these alterations are associated with postburn outcomes is not clear. Objective: The aim of the present study was to analyze lipid metabolic profiles in pediatric burn patients and to correlate these profiles with patient outcomes and hospital courses. Design and Setting: We conducted a prospective cohort study at an academic pediatric hospital burn center. Patients: Our study included 219 pediatric burn patients. Main Outcome Measures: Patients were stratified according to their plasma TG and FFA levels. Main patient outcomes, such as postburn morbidity and mortality, and clinical metabolic markers were analyzed. Results: All groups were similar in demographics and injury characteristics. Patients with elevated TGs had significantly worse clinical outcomes associated with increased acute-phase protein synthesis indicating augmented inflammation and hypermetabolism, whereas increased FFAs did not seem to profoundly alter postburn outcomes. Conclusions: Elevated TGs, but not FFAs, postburn are associated with worsened organ function and clinical outcomes. PMID:23150682

  19. 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. PMID:25433914

  20. Measurement of outcome in rheumatic diseases.

    OpenAIRE

    Wright, V

    1985-01-01

    In the assessment of outcome in rheumatic diseases a number of factors must be taken into account. It is important to make an accurate diagnosis, so that the response to treatment is not confused by heterogeneity of the population. The meaning of outcome needs to be defined. The quality of life over a prolonged period is just as important as the ultimate outcome. Subjective symptoms are important to the patient. Pain is the most important, followed by disability and then stiffness. Despite at...

  1. The impact of patient support programs on adherence, clinical, humanistic, and economic patient outcomes: a targeted systematic review

    Science.gov (United States)

    Ganguli, Arijit; Clewell, Jerry; Shillington, Alicia C

    2016-01-01

    Background Patient support programs (PSPs), including medication management and counseling, have the potential to improve care in chronic disease states with complex therapies. Little is known about the program’s effects on improving clinical, adherence, humanistic, and cost outcomes. Purpose To conduct a targeted review describing medical conditions in which PSPs have been implemented; support delivery components (eg, face-to-face, phone, mail, and internet); and outcomes associated with implementation. Data sources MEDLINE – 10 years through March 2015 with supplemental handsearching of reference lists. Study selection English-language trials and observational studies of PSPs providing at minimum, counseling for medication management, measurement of ≥1 clinical outcome, and a 3-month follow-up period during which outcomes were measured. Data extraction Program characteristics and related clinical, adherence, humanistic, and cost outcomes were abstracted. Study quality and the overall strength of evidence were reviewed using standard criteria. Data synthesis Of 2,239 citations, 64 studies met inclusion criteria. All targeted chronic disease processes and the majority (48 [75%]) of programs offered in-clinic, face-to-face support. All but 9 (14.1%) were overseen by allied health care professionals (eg, nurses, pharmacists, paraprofessionals). Forty-one (64.1%) reported at least one significantly positive clinical outcome. The most frequent clinical outcome impacted was adherence, where 27 of 41 (66%) reported a positive outcome. Of 42 studies measuring humanistic outcomes (eg, quality of life, functional status), 27 (64%) reported significantly positive outcomes. Only 15 (23.4%) programs reported cost or utilization-related outcomes, and, of these, 12 reported positive impacts. Conclusion The preponderance of evidence suggests a positive impact of PSPs on adherence, clinical and humanistic outcomes. Although less often measured, health care utilization and

  2. 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. PMID:26645090

  3. 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.

  4. A Systematic Review of Outcome Measurements and Quality of Studies Evaluating Fixed Tooth-Supported Restorations

    OpenAIRE

    Rajnikant Patel, D.; O'Brien, T; Petrie, A.; Petridis, H.

    2014-01-01

    The purpose of this systematic review was to review clinical studies of fixed tooth-supported prostheses, and to assess the quality of evidence with an emphasis on the assessment of the reporting of outcome measurements. Multiple hypotheses were generated to compare the effect of study type on different outcome modifiers and to compare the quality of publications before and after January 2005.

  5. Treatment of patients with hand osteoarthritis : outcome measures, patient satisfaction, and economic evaluation

    NARCIS (Netherlands)

    Marks, Miriam

    2014-01-01

    The aim of this thesis was to investigate the limitations in daily life, outcome measures, clinical outcomes with the emphasis on patient satisfaction, and economic aspects of the treatment of hand osteoarthritis (OA). Patients with hand OA report severe restrictions in daily life, in particular in

  6. Stents and statins: history, clinical outcomes and mechanisms.

    Science.gov (United States)

    Nair, Pradeep K; Mulukutla, Suresh R; Marroquin, Oscar C

    2010-09-01

    The 1980s witnessed the inception of both stents and 3-hydroxy-3-methyl-glutaryl-CoA reductase inhibitors (statins). While they evolved separately, it was soon realized that they each offered a unique and powerful mechanism for targeting the major offender in cardiovascular disease, namely atherosclerosis. Coincidentally, the first statin was approved by the US FDA in 1987, the same year that the coronary stent was conceived. Since that time, stents and statins have revolutionized the field of cardiovascular medicine and their paths have been intertwined. Several pivotal randomized clinical trials have established statins as an effective therapy for improving clinical outcomes after percutaneous coronary intervention (PCI) among patients presenting with stable coronary artery disease and acute coronary syndromes. In addition, chronic statin therapy and acute loading of statins prior to PCI has consistently been shown to limit periprocedural myocardial necrosis. The mechanism for improved clinical outcomes with statins has clearly been associated with statin-induced reductions in LDL. In addition, statins may also exert 'pleiotropic' effects, independent of LDL lowering, that might counteract the inflammatory and prothrombotic mileu created with PCI. This article provides a brief historical perspective of the evolution of the use of statins and stents in patients with coronary artery disease, an evaluation of the available clinical data supporting the use of statins in patients undergoing PCI across a wide spectrum of clinical scenarios, and a discussion of the potential mechanisms of the benefit of statins in these patients. PMID:20828351

  7. 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.

  8. 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

  9. Outcome measures in MMN revisited: further improvement needed.

    Science.gov (United States)

    Pruppers, Mariëlle H J; Draak, Thomas H P; Vanhoutte, Els K; Van der Pol, W-Ludo; Gorson, Kenneth C; Léger, Jean-Marc; Nobile-Orazio, Eduardo; Lewis, Richard A; van den Berg, Leonard H; Faber, Catharina G; Merkies, Ingemar S J

    2015-09-01

    The objectives of this study were to provide an overview of the outcome measures (OMs) applied in clinical trials in multifocal motor neuropathy (MMN) and to determine the responsiveness of a core set of selected OMs as part of the peripheral neuropathy outcome measures standardization (PeriNomS) study. The following OMs were serially applied in 26 patients with newly diagnosed or relapsing MMN, receiving intravenous immunoglobulin (assessments: T0/T3/T12 months): 14 muscle pairs MRC (Medical Research Council) scale, the Neuropathy Impairment Scale motor-subset, a self-evaluation scale, grip strength, and MMN-RODS© (Rasch-built overall disability scale). All data, except the grip strength, were subjected to Rasch analyses before determining responsiveness. For grip strength, responsiveness was examined using a combined anchor- (SF-36 question-2) and distribution-based (½ × SD) minimum clinically important difference (MCID) techniques, determining the proportion of patients exceeding both the identified cut-offs. For the remaining scales, the magnitude of change for each patient on each scale was determined using the MCID related to the individual SE (responder definition: MCID-SE ≥ 1.96). Overall, a great assortment of measures has been used in MMN trials with different responsiveness definitions. For the selected OMs, responsiveness was poor and only seen in one fourth to one third of the patients, the grip strength being more responsive. Despite the efforts taken to standardize outcome assessment, further clinimetric responsiveness studies are needed in MMN. PMID:26115442

  10. 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.

  11. Clinical and economic outcomes assessment in nuclear cardiology

    International Nuclear Information System (INIS)

    The future of nuclear medicine procedures, as understood within our current economic climate, depends upon its ability to provide relevant clinical information at similar or lower comparative costs. With an ever-increasing emphasis on cost containment, outcome assessment forms the basis of preserving the quality of patient care. Today, outcomes assessment encompasses a wide array of subjects including clinical, economic, and humanistic (i.e., quality of life) outcomes. For nuclear cardiology, evidence-based medicine would require a threshold level of evidence in order to justify the added cost of any test in a patient's work-up. This evidence would include large multicenter, observational series as well as randomized trial data in sufficiently large and diverse patient populations. The new movement in evidence-based medicine is also being applied to the introduction of new technologies, in particular when comparative modalities exist. In the past 5 years, it has seen a dramatic shift in the quality of outcomes data published in nuclear cardiology. This includes the use of statistically rigorous risk-adjusted techniques as well as large populations (i.e., >500 patients) representing multiple diverse medical care settings. This has been the direct result of the development of multiple outcomes databases that have now amassed thousands of patients worth of data. One of the benefits of examining outcomes in large patient datasets is the ability to assess individual endpoints (e.g., cardiac death) as compared with smaller datasets that often assess combined endpoints (e.g., death, myocardial infarction, or unstable angina). New technologies for the diagnosis of coronary artery disease have contributed to the rising costs of care. In the United States and in Europe, costs of care have risen dramatically, consuming an ever-increasing amount of available resources. The overuse of diagnostic angiography often leads to unnecessary revascularization that does not lead to

  12. Development of core outcome sets in hidradenitis suppurativa: systematic review of outcome measure instruments to inform the process.

    Science.gov (United States)

    Ingram, J R; Hadjieconomou, S; Piguet, V

    2016-08-01

    The recent hidradenitis suppurativa (HS) Cochrane review identified outcome measure heterogeneity as an important issue to address when designing future HS trials. Our objective was to follow the Harmonising Outcome Measures for Eczema (HOME) roadmap, by performing a systematic review of HS outcome measure instruments to inform the development of an HS core outcome set. We performed a systematic review to identify validation evidence for outcome measure instruments used in HS randomized controlled trials (RCTs), and assessed the methodological quality of all HS outcome measure validity studies using the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) checklist. The 12 RCTs included in the Cochrane review utilized 30 outcome measure instruments, including 16 physician-reported instruments, 11 patient-reported instruments and three composite measures containing elements of both. Twenty-seven (90%) of the instruments lacked any validation data. Two further instruments have been developed and partially validated. Of the seven studies meeting our inclusion criteria, six were of 'fair' or 'poor' methodological quality, in part because most of the studies were not primarily designed for instrument validation. The HiSCR instrument is supported by good-quality validation data, but there are gaps, including assessment of internal consistency, inter-rater reliability and minimal clinically important difference, and convergent validity fell below the acceptable range for some comparisons. Multiple, usually unvalidated, outcome measure instruments have been used in HS RCTs. Where validation evidence is available there are issues of low methodological quality or incomplete validity assessment and so, currently, no instruments can be fully recommended. PMID:26873867

  13. 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. PMID:26825404

  14. Clinical outcome of narrow diameter implants inserted into allografts

    Directory of Open Access Journals (Sweden)

    Maurizio Franco

    2009-08-01

    Full Text Available OBJECTIVE: Narrow diameter implants (NDI (i.e. diameter <3.75 mm are a potential solution for specific clinical situations, such as reduced interradicular bone, thin alveolar crest and replacement of teeth with small cervical diameter. NDI have been available in clinical practice since the 1990s, but only few studies have analyzed their clinical outcome and no study have investigated NDI inserted in fresh-frozen bone (FFB grafts. Thus, a retrospective study on a series of NDI placed in homologue FFB was designed to evaluate their clinical outcome. MATERIAL AND METHODS: In the period between December 2003 and December 2006, 36 patients (22 females and 14 males, mean age 53 years with FFB grafts were selected and 94 different NDI were inserted. The mean follow-up was 25 months. To evaluate the effect of several host-, surgery-, and implant-related factors, marginal bone loss (MBL was considered an indicator of success rate (SCR. The Kaplan Meier algorithm and Cox regression were used. RESULTS: Only 5 out of 94 implants were lost (i.e. survival rate - SVR 95.7% and no differences were detected among the studied variables. On the contrary, the Cox regression showed that the graft site (i.e. maxilla reduced MBL. CONCLUSIONS: NDI inserted in FFB have a high SVR and SCR similar to those reported in previous studies on regular and NDI inserted in non-grafted jaws. Homologue FFB is a valuable material in the insertion of NDI.

  15. 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. PMID:25895911

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

    Directory of Open Access Journals (Sweden)

    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. 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.

  18. 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

    IMMPACT for 4 core chronic pain outcome domains: (1) Pain intensity, assessed by a 0 to 10 numerical rating scale; (2) physical functioning, assessed by the Multidimensional Pain Inventory and Brief Pain Inventory interference scales; (3) emotional functioning, assessed by the Beck Depression Inventory...... and Profile of Mood States; and (4) participant ratings of overall improvement, assessed by the Patient Global Impression of Change scale. It is recommended that 2 or more different methods be used to evaluate the clinical importance of improvement or worsening for chronic pain clinical trial outcome...

  19. 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.

  20. Factor xiii deficiency in children-clinical presentation and outcome

    International Nuclear Information System (INIS)

    To determine the demographic features and clinical outcome of children with Factor XIII deficiency. Records of all hospitalized pediatric patients with discharge diagnosis of FXIII D, on the basis of factor XIII assay 5 mol/L urea test were retrospectively reviewed and abstracted on a pre-specified proforma. Demographic features, coagulation profile, family history and outcomes were noted. A total of 10 charts were reviewed. There were 5 boys and 5 girls. Almost all the children (9/10) were less than 5 years of age, out of whom 5 (50%) were infants, and 3 were neonates. Bruises and prolonged bleeding after trauma was the major presenting complaints in 80%, followed by prolonged bleeding from the umbilical stump in 2 patients. Nine patients had past history of prolonged umbilical bleeding. Two patients had history of FXIII D in siblings, while 2 had history of prolonged bleeding in other family members (cause unknown). Consanguinity was present in 80% of the families. Initial coagulation screen were normal in all patients. Two patients had intracranial hemorrhage, proved on neuro-imaging, were managed with plasma infusions and required craniotomy. The rest were managed conservatively with plasma transfusions. All were discharged alive in good clinical condition. Almost all were followed regularly in clinic with monthly cryoprecipitate transfusions. Although factor XIII deficiency is a rare genetic disorder in children with history of bruising, prolonged umbilical bleeding, family history of bleeding and consanguinity with normal initial coagulation screen (PT, APTT and platelets), FXIII D should be ruled out. (author)

  1. 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.

  2. Clinical characteristics and outcome of cancer diagnosed during pregnancy

    Science.gov (United States)

    Shim, Min Hee; Mok, Chi-Won; Chang, Kylie Hae-Jin; Sung, Ji-Hee; Oh, Soo-young; Roh, Cheong-Rae; Kim, Jong-Hwa

    2016-01-01

    Objective The aim of this study is to describe the clinical characteristics and outcome of cancer diagnosed during pregnancy. Methods This is a retrospective cohort study of women who were diagnosed with cancer during pregnancy at a tertiary academic hospital between 1995 and 2013. Maternal characteristics, gestational age at diagnosis, and type, stage, symptoms and signs of cancer for each patient were retrieved from the medical records. The cancer treatment, pregnancy management and the subsequent perinatal and maternal outcomes for each cancer were assessed. Results A total of 87 women were diagnosed with cancer during pregnancy (172.6 cases per 100,000 deliveries). The most common cancer was breast cancer (n=20), followed by gastrointestinal (n=17), hematologic (n=13), thyroid (n=11), central nervous system (n=7), cervical (n=7), ovarian (n=5), lung (n=3), and other cancers (n=4). Eighteen (20.7%) patients terminated their pregnancies. In the 69 (79.3%) patients who maintained their pregnancies, one patient miscarried and 34 patients delivered preterm. Of the preterm babies, 24 (70.6%) were admitted to the neonatal intensive care unit and 3 (8.8%) of those expired. The maternal mortality rate was 31.0%, with highest rate seen with lung cancers (66.7%), followed by gastrointestinal (50.0%), central nervous system (50.0%), hematologic (30.8%), breast (25.0%), ovarian (20.0%) cervical (14.3%), and thyroid cancers (0%). Conclusion The clinical characteristics and outcome of cancer during pregnancy were highly variable depending on the type of cancer. However, timely diagnosis and appropriate management of cancer during pregnancy may improve both maternal and neonatal outcome. PMID:26866029

  3. Clinical outcomes for patients with synovial sarcoma of the hand

    OpenAIRE

    Outani, Hidetatsu; Hamada, Kenichiro; Oshima, Kazuya; Joyama, Susumu; Naka, Norifumi; Araki, Nobuhito; Ueda, Takafumi; Yoshikawa, Hideki

    2014-01-01

    Purpose Soft tissue sarcoma of the hand is rare, and one of the most common histological diagnosis is synovial sarcoma. We report the clinical outcomes of patients with synovial sarcoma of the hand and discuss treatment strategies. Methods We reviewed five patients with synovial sarcoma of the hand treated at our institutions from 1983 to 2013. The mean patient age at the time of diagnosis was 36.6 years (range, 20–62 years). Two patients underwent marginal excision after neoadjuvant chemothe...

  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. Patient-reported outcome measures after total knee arthroplasty

    OpenAIRE

    Ramkumar, P. N.; Harris, J D; Noble, P. C.

    2015-01-01

    Objectives A lack of connection between surgeons and patients in evaluating the outcome of total knee arthroplasty (TKA) has led to the search for the ideal patient-reported outcome measure (PROM) to evaluate these procedures. We hypothesised that the desired psychometric properties of the ideal outcome tool have not been uniformly addressed in studies describing TKA PROMS. Methods A systematic review was conducted investigating one or more facets of patient-reported scores for measuring prim...

  6. 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

  7. Sensitivity of Outcome Measures for Treatments of Generalized Social Phobia.

    Science.gov (United States)

    Taylor, Steven; Woody, Sheila; McLean, Peter D.; Koch, William J.

    1997-01-01

    The sensitivity of five measures of outcomes of treatment for generalized social phobia was studied with 60 people diagnosed with generalized social phobia. Outcome measures were completed before and after treatment and three months later, and effect sizes were computed. Results support the usefulness of the Social Phobia and Anxiety Inventory (S.…

  8. Learning Outcomes across Disciplines and Professions: Measurement and Interpretation

    Science.gov (United States)

    Caspersen, Joakim; Frølich, Nicoline; Karlsen, Hilde; Aamodt, Per Olaf

    2014-01-01

    Learning outcomes of higher education are a quality tool in a changing higher education landscape but cannot be seen as neutral measures across professions and disciplines. Survey results from graduates and recent graduates indicate that prevailing measures of learning outcomes yield the same result within and across disciplinary and professional…

  9. Subacute Thyroiditis: Clinical Presentation and Long Term Outcome

    Directory of Open Access Journals (Sweden)

    Assim A. Alfadda

    2014-01-01

    Full Text Available Few studies have been reported from the Kingdom of Saudi Arabia (SA to describe the clinical presentation and long term outcomes of subacute thyroiditis (SAT. Our aim was to review the demographic, anthropometric, clinical presentation, laboratory results, treatment, and disease outcome in Riyadh region and to compare those with results from different regions of the Kingdom and different parts of the world. We reviewed the medical files of patients who underwent thyroid uptake scan during an 8-year period in King Khalid University Hospital. Only 25 patients had confirmed diagnosis of thyroiditis. Age and gender distribution were similar to other studies. Most patients presented with palpitation, goiter, and weight change. Elevated thyroid hormones, suppressed thyroid-stimulating hormone, and elevated ESR were reported. Among those, 7 cases of SAT were recorded. β-Blockers were prescribed to 57% and nonsteroidal anti-inflammatory drugs to 29% of SAT. Long follow-up demonstrated that 85.7% of SAT cases recovered, while 14.3% developed permanent hypothyroidism. In conclusion, SAT is uncommon in the central region of SA. Compared to the western region, corticosteroid is not commonly prescribed, and permanent hypothyroidism is not uncommon. A nation-wide epidemiological study to explain these interprovincial differences is warranted.

  10. Clinical outcome in measles patients hospitalized with complications

    International Nuclear Information System (INIS)

    Measles is a highly communicable viral illness and is common cause of childhood mortality and morbidity. Keeping in view the high prevalence of measles in the developing world, we carried out this study to look into the complicated measles cases and clinical outcome in patients admitted in children ward of Ayub Teaching Hospital. Detailed history and physical examination of all the hospitalized patients with complication of measles were recorded in a proforma. Immunization and nutritional status of each admitted patient was assessed and the clinical outcome of measles was compared with demographic profile. one hundred thirty six hospitalized patients with complications of measles were studied. There was 60.3% male and 57.3% of patients were vaccinated against measles. Malnourished patients were 71.35% and had longer hospital stay (>5 days). Pneumonia (39.7%) and diarrhoea (38.2%) were the commonest complications. Seven children died and encephalitis (57.1%) was the commonest cause of death. The most common complications of measles are pneumonia and diarrhoea with dehydration requiring admission. Malnutrition results in more complications and longer hospital stay. Mortality is significantly associated with encephalitis. (author)

  11. Spontaneous reduction of intussusception: clinical spectrum, management and outcome

    Energy Technology Data Exchange (ETDEWEB)

    Kornecki, A.; Daneman, A.; Navarro, O.; Connolly, B.; Manson, D.; Alton, D.J. [Toronto Univ., ON (Canada); Department of Diagnostic Imaging, Hospital for Sick Children, Toronto, ON (Canada)

    2000-01-01

    Background. To analyze the spectrum of clinical features, management and outcome of children with documented spontaneous reduction of intussusception (SROI). Materials and methods. Review of records of 50 children (33 boys, 17 girls; age range 11 days-15 years; mean age 4 years) with documented SROI, in whom intussusception was initially diagnosed by sonography (US) in 44, air enema in 2, and computed tomography in 4, in the 6-year period 1992-1998. Results. Symptoms suggestive of intussusception were present in 21 (3 of whom had Henoch-Schoenlein purpura and 4 had previous ileocolic intussusception reduced by air enema). Intussusception was an incidental finding in the other 29, in 28 of whom the finding was in the small bowel. Intussusception was limited to the small bowel in 43 and was ileocolic in 7. SROI was usually documented on US. Laparotomy performed in only 4 showed no evidence of intussusception or pathologic lead point. Outcome in all patients was favorable. Conclusions. SROI may present in symptomatic or asymptomatic children and occurs more commonly than previously reported. These intussusceptions are usually short-segment, small-bowel intussusceptions with no recognizable lead point. In asymptomatic patients, conservative observation is warranted. Intervention should be dictated by the clinical findings in symptomatic patients. (orig.)

  12. 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.

  13. Mushroom poisoning in children: clinical presentation and outcome

    International Nuclear Information System (INIS)

    A variable clinical picture characterizes mushroom poisoning. The Amatoxin, the main toxic component of these fungi, are responsible for gastrointestinal symptoms as well as hepatic and renal failure. As acute gastroenteritis is extremely common in our set up, so every patient presenting with these symptoms is treated as gastroenteritis of viral aetiology. The authors present the clinical picture of the phalloid syndrome, its treatment and immediate outcome. All children age less than 16 years admitted in Saidu Hospital Swat from January to December 2006 with mushroom poisoning were included in the study. Patients with doubtful history or with associated illness were not included. The diagnosis was based on the clinical picture of the patient, history and the laboratory data. In addition to maintenance of fluid and electrolyte balance and treating sepsis, oral Silymarin and intravenous penicillin was started. Liver function tests, renal functions tests, serum electrolytes and coagulation profile was done in all the patients. The severity of poisoning was graded according to hepatic transaminase elevations and prolongation of prothrombin time. Of the 18 patients, fifteen were above five years of age. Female were twice in number. Fifteen patients developed hepatic failure and three patients developed renal failure. Thirteen patients expired. To start timely management, Mushroom poisoning should be considered in the differential diagnosis in patients presenting with food poisoning particularly coming in groups. Delay in diagnosis is associated with high mortality. (author)

  14. Knee instruments and rating scales designed to measure outcomes

    OpenAIRE

    Rodríguez Merchán, E. Carlos

    2012-01-01

    In this article, the knee instruments and rating scales that are designed to measure outcomes are revised. Although the International Knee Documentation Committee Subjective Knee Form can be used as a general knee measure, no instrument is currently universally applicable across the spectrum of knee disorders and patient groups. Clinicians and researchers looking to use a patient-based score for measurement of outcomes must consider the specific patient population in which it has been evaluat...

  15. Using Learning Outcome Measures to assess Doctoral Nursing Education

    OpenAIRE

    Raup, Glenn H.; King, Jeff; Hughes, Romana J.; Faidley, Natasha

    2010-01-01

    Education programs at all levels must be able to demonstrate successful program outcomes. Grades alone do not represent a comprehensive measurement methodology for assessing student learning outcomes at either the course or program level. The development and application of assessment rubrics provides an unequivocal measurement methodology to ensure a quality learning experience by providing a foundation for improvement based on qualitative and quantitatively measurable, aggregate course and p...

  16. Clinical Outcomes of Primary Palatal Surgery in Children with Nonsyndromic Cleft Palate with and without Lip

    OpenAIRE

    Seunghee Ha; Kyung S. Koh; Heewon Moon; Seungeun Jung; Tae Suk Oh

    2015-01-01

    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 include...

  17. 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.

  18. Measuring Outcomes for Children Late Placed for Adoption.

    Science.gov (United States)

    Rushton, Alan

    1998-01-01

    Describes the selection of outcome measures used by the Maudsley Family Research team to assess outcomes--across a broad range of developmental dimensions--of permanent placement for children and adolescents. Developed a package of instruments to examine child emotional, cognitive, social, and academic development; attachment; and self-esteem, for…

  19. 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.

  20. 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.

  1. 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

  2. A Systematic Review of Outcome Measurements and Quality of Studies Evaluating Fixed Tooth-Supported Restorations

    OpenAIRE

    Patel, Devangkumar Rajnikant; O'Brien, Tim; Petrie, Aviva; Petridis, Haralampos

    2014-01-01

    Purpose The purpose of this systematic review was to review clinical studies of fixed tooth-supported prostheses, and to assess the quality of evidence with an emphasis on the assessment of the reporting of outcome measurements. Multiple hypotheses were generated to compare the effect of study type on different outcome modifiers and to compare the quality of publications before and after January 2005. Materials and Methods An electronic search was conducted using specific databases (MEDLINE v...

  3. Surrogacy assessment using principal stratification when surrogate and outcome measures are multivariate normal

    OpenAIRE

    Conlon, Anna S. C.; Taylor, Jeremy M.G.; Elliott, Michael R.

    2013-01-01

    In clinical trials, a surrogate outcome variable (S) can be measured before the outcome of interest (T) and may provide early information regarding the treatment (Z) effect on T. Using the principal surrogacy framework introduced by Frangakis and Rubin (2002. Principal stratification in causal inference. Biometrics 58, 21–29), we consider an approach that has a causal interpretation and develop a Bayesian estimation strategy for surrogate validation when the joint distribution of potential...

  4. The impact of patient support programs on adherence, clinical, humanistic, and economic patient outcomes: a targeted systematic review

    Directory of Open Access Journals (Sweden)

    Ganguli A

    2016-04-01

    Full Text Available Arijit Ganguli,1 Jerry Clewell,2 Alicia C Shillington3 1Department of Health Economics and Outcomes Research, 2Department of Medical Affairs, AbbVie, North Chicago, IL, USA; 3EPI-Q Inc., Oak Brook, IL, USA Background: Patient support programs (PSPs, including medication management and counseling, have the potential to improve care in chronic disease states with complex therapies. Little is known about the program’s effects on improving clinical, adherence, humanistic, and cost outcomes. Purpose: To conduct a targeted review describing medical conditions in which PSPs have been implemented; support delivery components (eg, face-to-face, phone, mail, and internet; and outcomes associated with implementation. Data sources: MEDLINE – 10 years through March 2015 with supplemental handsearching of reference lists. Study selection: English-language trials and observational studies of PSPs providing at minimum, counseling for medication management, measurement of ≥1 clinical outcome, and a 3-month follow-up period during which outcomes were measured. Data extraction: Program characteristics and related clinical, adherence, humanistic, and cost outcomes were abstracted. Study quality and the overall strength of evidence were reviewed using standard criteria. Data synthesis: Of 2,239 citations, 64 studies met inclusion criteria. All targeted chronic disease processes and the majority (48 [75%] of programs offered in-clinic, face-to-face support. All but 9 (14.1% were overseen by allied health care professionals (eg, nurses, pharmacists, paraprofessionals. Forty-one (64.1% reported at least one significantly positive clinical outcome. The most frequent clinical outcome impacted was adherence, where 27 of 41 (66% reported a positive outcome. Of 42 studies measuring humanistic outcomes (eg, quality of life, functional status, 27 (64% reported significantly positive outcomes. Only 15 (23.4% programs reported cost or utilization-related outcomes, and, of

  5. Speech tests as measures of outcome.

    Science.gov (United States)

    Gatehouse, S

    1998-01-01

    Speech tests comprise an important and integral part of any assessment of the effectiveness of intervention for hearing disability and handicap. Particularly when considering hearing aid services for adult listeners, careful consideration has to be given to the particular form and application of inferences drawn from speech identification procedures if erroneous conclusions are to be avoided. It is argued that four such components relate to the statistical properties and discriminatory leverage of speech identification procedures, the choice of presentation level and conditions in regard to the auditory environment experienced by hearing-impaired clients, the extent to which speech tests based on segmental intelligibility provide appropriate information in relationship to perceived disabilities and handicaps, and the ways in which speech identification procedures to evaluate the potential benefits of signal-processing schemes for hearing aids are dependent upon sufficient listening experiences. Data are drawn from the literature to illuminate these points in terms of application in clinical practice and clinical evaluation exercises, and also with regard to future research needs. PMID:10209778

  6. Ebola in children: epidemiology, clinical features, diagnosis and outcomes.

    Science.gov (United States)

    Olupot-Olupot, Peter

    2015-03-01

    Ebola virus disease is caused by a highly contagious and pathogenic threadlike RNA virus of the Filoviridae family. The index human case is usually a zoonosis that launches human-to-human transmission interface with varying levels of sustainability of the epidemic depending on the level of public health preparedness of the affected country and the Ebola virus strain. The disease affects all age groups in the population. Clinical diagnosis is challenging in index cases especially in the early stages of the disease when the presenting features are usually nonspecific and only similar to a flu-like illness. However, in the agonal stages, hemorrhage frequently occurs in a high proportion of cases. The diagnostic gold standard is by detecting the antigen using reverse transcription-polymerase chain reaction. Mortality rates in the past 28 outbreaks since 1976 have ranged from 30% to 100% in different settings among adults, but lower mortality rates have been documented in children. This review aims to describe Ebola virus infection, clinical presentation, diagnosis and outcomes in children. PMID:25522340

  7. 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.

  8. Predictors of treatment outcome among Asian pathological gamblers (PGs): clinical, behavioural, demographic, and treatment process factors.

    Science.gov (United States)

    Guo, Song; Manning, Victoria; Thane, Kyaw Kyaw Wai; Ng, Andrew; Abdin, Edimansyah; Wong, Kim Eng

    2014-03-01

    Research on predictors of treatment outcome among pathological gamblers (PGs) is inconclusive and dominated by studies from Western countries. Using a prospective longitudinal design, the current study examined demographic, clinical, behavioural and treatment programme predictors of gambling frequency at 3, 6 and 12-months, among PGs treated at an addiction clinic in Singapore. Measures included the Hospital anxiety and depression scale, gambling symptom assessment scale (GSAS), personal well-being index (PWI), treatment perception questionnaire and gambling readiness to change scale. Treatment response in relation to changes in symptom severity, personal wellbeing and abstinence were also assessed. Abstinence rates were 38.6, 46.0 and 44.4 % at 3, 6 and 12-months respectively. Significant reductions in gambling frequency, GSAS, and improvement in PWI were reported between baseline and subsequent outcome assessments, with the greatest change occurring in the initial three months. No demographic, clinical, behavioural or treatment programme variable consistently predicted outcome at all three assessments, though treatment satisfaction was the most frequent significant predictor. However, being unemployed, having larger than average debts, poor treatment satisfaction and attending fewer sessions at the later stages of treatment were associated with significantly poorer outcomes, up to 1-year after initiating treatment. These findings show promise for the effectiveness of a CBT-based treatment approach for the treatment of predominantly Chinese PGs. Clinical implications and suggestions for future research are discussed. Taken together, the findings suggest early treatment satisfaction is paramount in improving short-term outcomes, with baseline gambling behaviour and treatment intensity playing a more significant role in the longer term. PMID:22945784

  9. Importance of outcomes Measurement of CSR programmes - Case Nokia

    OpenAIRE

    Talvitie-Sirén, Reeta

    2009-01-01

    Abstract: Objectives of the Thesis The objective of the thesis was to find out how companies measure the societal and business outcomes of their CSR activities as well as to find out the reasons why outcomes measurement is considered important. The focus was on the societal aspect of CSR, and all programmes studied were community related CSR programmes. The programmes studied were categorised according to a framework of CSR action types modified from Halme and Laurila (2009). A fourth cate...

  10. Clinical presentations and outcomes of Filipino juvenile systemic lupus erythematosus

    Directory of Open Access Journals (Sweden)

    Dans Leonila F

    2011-02-01

    Full Text Available Abstract Objective Juvenile Systemic Lupus Erythematosus (SLE varies by location and ethnicity. This study describes the clinical, laboratory profile and outcome of juvenile SLE seen at Philippine General Hospital (PGH from 2004-2008. Method Medical charts of all Filipino Juvenile SLE cases admitted at PGH during the 5-year period were reviewed collecting demographic profile, clinical and laboratory manifestations and treatment during disease course. Results Seventy-eight cases of juvenile SLE were reviewed. There were 7 boys and 71 girls. The mean age at diagnosis was 14 years (SD 2.7 with a range of 8-18 years. Fever (52.5% and malar rash (41.0% were the most common features at disease onset. At the time of diagnosis, the most common features were malar rash (65.3%, renal involvement (62.8% and photosensitivity (55.1%. Mucocutaneous (92.3%, renal (71.7% and hematologic (69.2% involvement were the most common features during the entire course of illness. Infection (34.5% and neurologic (19.0% complications were observed most frequently. Corticocosteroid treatment was given in most of the patients in the form of prednisone (97.4% and concomitant methylprednisolone intravenous pulses (29.4%. Nine patients died during the study period. The overall 5-year mortality rate was 11.5%. Infection (77.0% was the most frequent cause of death. Conclusion Malar rash was a common feature at disease onset and at diagnosis among Filipinos with juvenile SLE. Throughout the disease course, renal involvement occurs in 71.7% of patients. Infection was the leading cause of complication and death. The clinical presentations of Filipinos with juvenile SLE were similar to juvenile SLE in other countries.

  11. Measuring outcomes in craniofacial and pediatric plastic surgery.

    Science.gov (United States)

    Wong, Karen W Y; Forrest, Christopher R; Goodacre, Tim E E; Klassen, Anne F

    2013-04-01

    This article discusses the measurement of outcomes in craniofacial and pediatric plastic surgery, using examples of craniosynostosis and cleft lip and/or palate (CLP). The challenges in measuring the standard outcomes of function, aesthetics, and health-related quality of life are discussed, along with the importance of developing evidence and studying quality improvement in this specialty. The need to define specific and comprehensive goals is discussed with a focus on patient-reported outcomes (PROs). Examples from the development of the CLEFT-Q, a PRO instrument for patients with CLP, are provided to support the need to seek the patient perspective. PMID:23506771

  12. 42 CFR 482.80 - Condition of participation: Data submission, clinical experience, and outcome requirements for...

    Science.gov (United States)

    2010-10-01

    ...) Standard: Clinical experience. To be considered for initial approval, an organ-specific transplant center..., clinical experience, and outcome requirements for initial approval of transplant centers. 482.80 Section... Hospitals Transplant Center Data Submission, Clinical Experience, and Outcome Requirements §...

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

    Science.gov (United States)

    Colonna, Annalisa; Smith, Anna B; Pal, Deb K; Gringras, Paul

    2015-01-01

    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. PMID:26029140

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

    Directory of Open Access Journals (Sweden)

    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.

  15. Framework and guidance for implementing patient-reported outcomes in clinical practice: evidence, challenges and opportunities.

    Science.gov (United States)

    Porter, Ian; Gonçalves-Bradley, Daniela; Ricci-Cabello, Ignacio; Gibbons, Chris; Gangannagaripalli, Jaheeda; Fitzpatrick, Ray; Black, Nick; Greenhalgh, Joanne; Valderas, Jose M

    2016-08-01

    Patient-reported outcomes (PROs) are reports of the status of a patient's health condition that come directly from the patient. While PRO measures are a well-developed technology with robust standards in research, their use for informing healthcare decisions is still poorly understood. We review relevant examples of their application in the provision of healthcare and examine the challenges associated with implementing PROs in clinical settings. We evaluate evidence for their use and examine barriers to their uptake, and present an evidence-based framework for the successful implementation of PROs in clinical practice. We discuss current and future developments for the use of PROs in clinical practice, such as individualized measurement and computer-adaptive testing. PMID:27427277

  16. 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.

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

    Science.gov (United States)

    Dizdar, Oguzhan Sıtkı; Baspınar, Osman; Kocer, Derya; Dursun, Zehra Bestepe; Avcı, Deniz; Karakükcü, Cigdem; Çelik, İlhami; Gundogan, Kursat

    2016-03-01

    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. PMID:26938553

  18. Clinical effectiveness and safety outcomes associated with prothrombin complex concentrates.

    Science.gov (United States)

    Hedges, Ashley; Coons, James C; Saul, Melissa; Smith, Roy E

    2016-07-01

    Prothrombin complex concentrates (PCCs) are indicated for urgent reversal of warfarin and used for reversal of novel oral anticoagulants, in patients with acute major bleeding or need for an urgent procedure. The research goal was to evaluate effectiveness and safety outcomes with PCC usage at our institution. A retrospective review of electronic medical records identified patients that received a PCC commercially available in the United States (KCentra(®) or Profilnine(®)) at twelve hospitals in a tertiary care health system from July 1, 2013 to April 30, 2014. A total of 193 patients received PCC, of which 184 patients received four-factor PCC. The patient population was 48 % male and 75 % Caucasian, with a mean age of 73 years old. Clinical outcomes of interest included time to achieve a target INR ≤1.3, time to Hgb >7 g/dL, and incidence of thromboembolism. A total of 143 patients were on warfarin (74.1 %) at baseline, whereas 18 patients (9.3 %) were taking a novel anticoagulant. Target INR of ≤1.3 was achieved in 125 patients (65.8 %), within a median time of 8.03 h (IQR 3.38-34.07). Among patients with a baseline Hgb 7 g/dL was 8.48 h (IQR 6.95-13.00). Eight patients (4.1 %) developed an acute venous thromboembolism following PCC administration. INR reversal was achieved in approximately two-thirds of patients, with a low incidence of venous thromboembolism. Four-factor PCC is a viable alternative to plasma. PMID:26685667

  19. Clinical attributes and surgical outcomes of angiocentric gliomas.

    Science.gov (United States)

    Ampie, Leonel; Choy, Winward; DiDomenico, Joseph D; Lamano, Jonathan B; Williams, Christopher Kazu; Kesavabhotla, Kartik; Mao, Qinwen; Bloch, Orin

    2016-06-01

    Angiocentric gliomas (AG) are exceedingly rare low-grade neoplasms which often present in the form of intractable epilepsy within younger patients. The current study extensively reviews all reported cases which were pathologically verified as AG in the literature to analyze clinical attributes and surgical outcomes of this neoplasm. There were 88 patients with AG reported in the literature consisting mostly of pediatric cases. The sex distribution consisted of 45 males and 36 females with the remaining seven cases not documenting sex. The average age of initial diagnosis was 16years with almost half of all diagnosed patients being within the first decade of life. In cases where extent of resection was reported, gross total resection (GTR) was achieved in 54 patients, subtotal resection (STR) in 16, and biopsy only in three. Post-operative complications were transient and only occurred in three patients with no reports of death following surgery. Only five cases reported tumor recurrence on follow-up. Eight patients had seizure recurrence post-operatively and GTR offered improved rates of seizure control when compared to STR (p=0.0005). Nearly half of the cases of AG are diagnosed within the first decade of life and they usually manifest with intractable seizures. GTR appears to offer better seizure control in the post-operative period. Surgical resection is the mainstay therapy for AG as post-operative complications and tumor recurrence remain uncommon. Since the number of reported cases is limited, future studies with longer follow-up periods will help elaborate more long-term outcomes. PMID:26778052

  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. PMID:26884781

  1. 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.

  2. Clinical spectrum and outcome of pulmonary nocardiosis: 5-year experience

    Science.gov (United States)

    Singh, Akashdeep; Chhina, Deepinder; Soni, RK; Kakkar, Chandan; Sidhu, US

    2016-01-01

    Background: Pulmonary nocardiosis is a rare but a life-threatening infection caused by Nocardia spp. The diagnosis is often missed and delayed resulting in delay in appropriate treatment and thus higher mortality. Aim: In this study, we aim to evaluate the clinical spectrum and outcome of patients with pulmonary nocardiosis. Methods: A retrospective, 5-year (2009–2014) review of demographic profile, risk factors, clinical manifestations, imaging findings, treatment, and outcome of patients with pulmonary nocardiosis admitted to a tertiary care hospital. Results: The median age of the study subjects was 54 years (range, 16–76) and majority of them (75%) were males. The risk factors for pulmonary nocardiosis identified in our study were long-term steroid use (55.6%), chronic lung disease (52.8%), diabetes (27.8%), and solid-organ transplantation (22.2%). All the patients were symptomatic, and the most common symptoms were cough (91.7%), fever (78%), and expectoration (72%). Almost two-third of the patients were initially misdiagnosed and the alternative diagnosis included pulmonary tuberculosis (n = 7), community-acquired pneumonia (n = 5), lung abscess (n = 4), invasive fungal infection (n = 3), lung cancer (n = 2), and Wegener's granulomatosis (n = 2). The most common radiographic features were consolidation (77.8%) and nodules (56%). The mortality rate for indoor patients was 33% despite treatment. Higher mortality rate was observed among those who had brain abscess (100.0%), HIV positivity (100%), need for mechanical ventilation (87.5%), solid-organ transplantation (50%), and elderly (age > 60 years) patients (43%). Conclusion: The diagnosis of pulmonary nocardiosis is often missed and delayed resulting in delay in appropriate treatment and thus high mortality. A lower threshold for diagnosing pulmonary nocardiosis needs to be exercised, in chest symptomatic patients with underlying chronic lung diseases or systemic immunosuppression, for the early diagnosis

  3. Outcome research in palliative care: could it represent a new dimension of clinical research or clinical practice?

    Science.gov (United States)

    Tassinari, Davide; Maltoni, Marco; Sartori, Sergio; Fantini, Manuela; Poggi, Barbara; Ravaioli, Alberto

    2005-03-01

    Outcome research is a new dimension of clinical research, and all fields of clinical medicine are involved in this kind of analysis. Overall survival and quality of life are the main outcomes identified in clinical oncology. The former must be the main outcome whenever possible; the latter has to be the main outcome when an improvement of overall survival cannot be expected. It follows that quality of life is the main outcome of palliative care, in which the patient instead of the disease represents the target of the clinical approach. In our critical paper, we review the meaning of clinical outcomes in palliative care, classifying the outcomes as main and surrogate outcomes, and the results of the trials as indexes of activity and efficacy of a treatment. We also review the main randomized clinical trials on the treatment of cancer cachexia, trying to define the role of the treatments in cachexia-related symptom control and quality of life improvement. Strictly related to outcome analysis is the dimension of pharmacoeconomic evaluation. The models of the different designs of pharmacoeconomic analysis are revisited in an attempt to conjugate the pharmacoeconomic evaluation with the particular dimension of palliative care. PMID:15580363

  4. 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).

  5. A Measurement Feedback System (MFS) Is Necessary to Improve Mental Health Outcomes

    Science.gov (United States)

    Bickman, Leonard

    2008-01-01

    The importance of measurement feedback system (MFS) for the improvement of mental health services for youths is discussed. As feedback obtained from clients and families is subject to distortions, a standardized MFS including clinical processes, contexts, outcomes, and feedback to clinicians and supervisors is necessary for improvement in quality…

  6. 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…

  7. 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.

  8. Retrospective case series of clinical outcomes associated with chiropractic management for veterans with low back pain

    Directory of Open Access Journals (Sweden)

    Andrew S. Dunn, DC, MS, MEd

    2011-10-01

    Full Text Available Musculoskeletal complaints, most notably low back pain (LBP, are prevalent among veterans. Despite a focus on LBP management by chiropractors within the Veterans Health Administration, limited published accounts detail clinical outcomes with chiropractic management of LBP among veterans. This was a retrospective case series of 171 veterans with a chief complaint of LBP who were managed with chiropractic care. Descriptive statistics and paired t-tests were used, with the Numeric Rating Scale (NRS and the Back Bournemouth Questionnaire (BBQ serving as the outcome measures. A minimum clinically important difference (MCID was set as 30% improvement from baseline for both measures. The mean number of treatments was 8.7. For the NRS, the mean raw score improvement was 2.2 points, representing 37.4% change from baseline; 103 (60.2% patients met or exceeded the MCID. For the BBQ, the mean raw score improvement was 13.6 points, representing 34.6% change from baseline; 92 patients (53.8% met or exceeded the MCID. For this sample of veterans with LBP, the mean percentages of clinical improvement were statistically significant and clinically meaningful for both the NRS and BBQ.

  9. Uterine arterial embolization for uterine leiomyoma: efficacy and clinical outcome

    International Nuclear Information System (INIS)

    To determine the efficacy and clinical outcome of uterine arterial embolization as a new approach to the management of uterine leiomyomas. Uterine arterial embolization was performed in 21 patients aged 26-62(mean, 42) years. Twenty of these had menorrhagia, dysmenorrhea, and mass-related symptoms (low abdominal discomfort, backache, urinary frequency, etc.) and one was diagnosed incidentally. Bilateral uterine arteries were selected individually and polyvinyl alcohol and/or gelfoam was used as an embolic material. Nineteen patients were followed up after embolization. Seventeen (89.5 %)reported satisfactory improvement of symptoms and follow-up sonography three months later showed a 58.5 % reduction in mean myoma volume. In 17 patients (89.5 %), the menstrual cycle returned to normal. All patients experienced pain after the procedure and other complications were vaginal bleeding (26.3 %) and fever (23.8 %). Uterine arterial embolization represents a new approach to the management of uterine leiomyoma-related symptoms. Further investigations and long-term follow-up are, however, enquired

  10. Uterine arterial embolization for uterine leiomyoma: efficacy and clinical outcome

    Energy Technology Data Exchange (ETDEWEB)

    Park, Jeong Seon; Lee, Do Yon; Kim, Yong Tae; Park, Ki Hyun; Park, Yong Won; Cho, Jae Sung; Kim, Myung Jun [Yonsei Univ. College of Medicine, Seoul (Korea, Republic of); Won, Je Hwan [Ajou Univ. College of Medicine, Suwon (Korea, Republic of); Kang, Byung Chul [Ewha Womans Univ. College of Medicine, Seoul (Korea, Republic of)

    1999-09-01

    To determine the efficacy and clinical outcome of uterine arterial embolization as a new approach to the management of uterine leiomyomas. Uterine arterial embolization was performed in 21 patients aged 26-62(mean, 42) years. Twenty of these had menorrhagia, dysmenorrhea, and mass-related symptoms (low abdominal discomfort, backache, urinary frequency, etc.) and one was diagnosed incidentally. Bilateral uterine arteries were selected individually and polyvinyl alcohol and/or gelfoam was used as an embolic material. Nineteen patients were followed up after embolization. Seventeen (89.5 %)reported satisfactory improvement of symptoms and follow-up sonography three months later showed a 58.5 % reduction in mean myoma volume. In 17 patients (89.5 %), the menstrual cycle returned to normal. All patients experienced pain after the procedure and other complications were vaginal bleeding (26.3 %) and fever (23.8 %). Uterine arterial embolization represents a new approach to the management of uterine leiomyoma-related symptoms. Further investigations and long-term follow-up are, however, enquired.

  11. ASSESSMENT OF SURGICAL OUTCOMES OF RHINOPLASTY – A CLINICAL STUDY

    Directory of Open Access Journals (Sweden)

    Tanthry Deepalakshmi

    2015-12-01

    Full Text Available Rhinoplasty is one of the most common cosmetic surgery performed by the otorhinolaryngologists. The main indication for rhinoplasty is cosmetic or functional or both. In regard to paucity of research regarding patient satisfaction after surgery, we have done this prospective clinical study in our hospital. 40 patients were included in the study from January 2012 to December 2012. Rhinoplasty Outcomes Evaluation (ROE Questionnaire was applied to all the patients and evaluation of the satisfaction pre op and post operatively was assessed and the results were statistically analysed. The age of the study group ranged from 20 yrs to 39 yrs with the mean age of 24.85 +/- 3.43 years. The average satisfaction mark of patients undergoing rhinoplasty in pre-operative state was 28.05 & post-operative it improved and reached to 67.91.The average satisfaction of female were 26.75 preoperatively reached to 63.68 postoperatively. The average satisfaction of male were 31.2 preoperatively reached upto 67.91 post operatively. The degree of the satisfaction pre and post operatively was compared using student t test and paired t test. It was 67.91 in males and 36.53 among females which was statistically significant (p < 0.05. Patient satisfaction is as important as technical aspects of rhinoplasty. Hence a novel attempt is made in this direction to assess and understand patient expectations to achieve realistic goals in rhinoplasty.

  12. PERFORATED PEPTIC ULCER: A CLINICAL ANALYSIS AND OUTCOME

    Directory of Open Access Journals (Sweden)

    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. Associations between HIV-RNA-based indicators and virological and clinical outcomes

    DEFF Research Database (Denmark)

    Laut, Kamilla G.; Shepherd, Leah C.; Pedersen, Court;

    2016-01-01

    measurements after baseline (the latest of 01/01/2001 or entry into EuroSIDA). Using multivariate Poisson regression, we modelled the association between short-term (resistance, triple-class failure) and long-term (all-cause mortality, any AIDS/non-AIDS clinical event) outcomes and the indicators: viraemia...... copy years; consecutive months with viral load ≥50 copies/ml; percentage of time on ART spent fully suppressed (%FS); stable on ART; 48 weeks snapshot; and current viral load. Indicators were compared using area under the ROC curve (AUC) and different measures of model fit. Results: Adjusted incidence...... rate ratios for all outcomes tended to increase with increasing viraemia copy years, number of consecutive months with viral load ≥50 copies/ml, current viral load and with lower %FS, but the gradient of increased risk was weak across strata. None of the indicators reliably identified those at risk...

  14. Maternal characteristics and clinical diagnoses influence obstetrical outcomes in Indonesia.

    Science.gov (United States)

    Adisasmita, Asri; Smith, Carl V; El-Mohandes, Ayman A E; Deviany, Poppy Elvira; Ryon, Judith J; Kiely, Michele; Rogers-Bloch, Quail; Gipson, Reginald F

    2015-07-01

    This Indonesian study evaluates associations between near-miss status/death with maternal demographic, health care characteristics, and obstetrical complications, comparing results using retrospective and prospective data. The main outcome measures were obstetric conditions and socio-economic factors to predict near-miss/death. We abstracted all obstetric admissions (1,358 retrospective and 1,240 prospective) from two district hospitals in East Java, Indonesia between 4/1/2009 and 5/15/2010. Prospective data added socio-economic status, access to care and referral patterns. Reduced logistic models were constructed, and multivariate analyses used to assess association of risk variables to outcome. Using multivariate analysis, variables associated with risk of near-miss/death include postpartum hemorrhage (retrospective AOR 5.41, 95 % CI 2.64-11.08; prospective AOR 10.45, 95 % CI 5.59-19.52) and severe preeclampsia/eclampsia (retrospective AOR 1.94, 95 % CI 1.05-3.57; prospective AOR 3.26, 95 % CI 1.79-5.94). Associations with near-miss/death were seen for antepartum hemorrhage in retrospective data (AOR 9.34, 95 % CI 4.34-20.13), and prospectively for poverty (AOR 2.17, 95 % CI 1.33-3.54) and delivering outside the hospital (AOR 2.04, 95 % CI 1.08-3.82). Postpartum hemorrhage and severe preeclampsia/eclampsia are leading causes of near-miss/death in Indonesia. Poverty and delivery outside the hospital are significant risk factors. Prompt recognition of complications, timely referrals, standardized care protocols, prompt hospital triage, and structured provider education may reduce obstetric mortality and morbidity. Retrospective data were reliable, but prospective data provided valuable information about barriers to care and referral patterns. PMID:25656716

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

    Directory of Open Access Journals (Sweden)

    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

  16. 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. PMID:26447704

  17. Endodontic retreatment. Aspects of decision making and clinical outcome.

    Science.gov (United States)

    Kvist, T

    2001-01-01

    Epidemiological surveys have reported that 25%-35% of root filled teeth are associated with periapical radiolucencies. Descriptive studies have demonstrated that clinicians' decision making regarding such teeth are subject to substantial variation. A coherent model to explain the observed variation has not been produced. In the present thesis a "Praxis Concept theory" was proposed. The theory suggests that dentists perceive periapical lesions of varying sizes as different stages on a continuous health scale. Interindividual variations can then be regarded as the result of the choice of different cut-off points on the continuum for prescribing retreatment. In the present study experiments among novice and expert decision makers gave evidence in favour of the theory. Data also suggested that the choice of retreatment criterion is affected by values, costs of retreatment and technical quality of original treatment. From a prescriptive point of view, the presence of a persistent periapical radiolucency has often been used as a criterion of endodontic "failure" and as an indication for endodontic retreatment. As an alternative decision strategy, the use of decision analysis has been proposed. Logical display of decision alternatives, values of probabilities, utility values (U-values) of the different outcomes and calculation of optimal decision strategy are features of this theory. The implementation of this approach is impeded by the uncertainty of outcome probabilities and lack of investigations concerning U-values. U-values of two periapical health states in root filled teeth (with and without a periapical lesion respectively) were investigated in a group of 82 dental students and among 16 Swedish endodontists. Two methods were used to elicit U-values: Standard gamble and Visual Analogue Scale. Large interindividual variation for both health states were recorded. The difference in U-values between the two health states was found to be statistically significant

  18. Clinical Profile and Outcome of Complicated Plasmodium falciparum Malaria

    Directory of Open Access Journals (Sweden)

    Virendra C patil

    2012-01-01

    Full Text Available Context: Complicated Plasmodium falciparum Malaria is a syndrome and a disease of protean, clinical manifestations including jaundice, ARF, ARDS and multi-organ failure. Aims: The objectives of the present study are to study clinical features, complications and factors affecting outcome of patients with complicated P. falciparum Malaria. Settings and Design: This retrospective descriptive study was conducted at tertiary care centre in western Maharashtra from January 2010 to December 2010. Methods and Material: Total 73 patients with complicated P. falciparum malaria who presented with fever having positive trophozoites of P. falciparum in blood smear were included. SPSS (version-10 software was used for all statistical calculations. Results: A total 73 patients had complicated P. falciparum malaria with 52 were males and 21 were female patients. Total 9 (12.32 % patients were presented with shock as a presenting feature. Four (5.47 % patients had hypoglycaemia at the time of admission. Total 43 (58.90 % patients had jaundice, 37 (50.68 % had anaemia, 28 (38.35 % had cerebral malaria, 7 (9.58 % had acute renal failure, 5 (6.84 % had ARDS and 5 (6.84 % had thrombocytopenia. Total 46 patients had single complication in the form of cerebral malaria 14 (19.17 %, jaundice 15 (20.54 % and anaemia 16 (21.91 %. Total 14 patients had two complications in the form of jaundice with ARF 02 (2.73 % with one (50 % death and jaundice with anaemia 12 (16.43 %. Total 9 (12.32 % patients had three complications in the form of cerebral malaria with jaundice with anaemia with 3 deaths (33.33 %. Total 5 (6.84 % patients had multiple complications in the form of cerebral malaria with ARF with ARDS with thrombocytopenia with 4 (80 % death. Case fatality rate was 10.95 %. The case fatality rate with ARDS was 80 % (4/5, with ARF was 57.14 % (4/7 and with cerebral malaria it was 25 % (7/28. Case fatality rate was highest in patients with pulmonary complication (ARDS

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

    International Nuclear Information System (INIS)

    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.

  20. 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.

  1. The clinical outcome of thymectomy in myasthenia gravis

    Directory of Open Access Journals (Sweden)

    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.

  2. 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...... on Incontinence has initiated the development and evaluation of disease-specific questionnaires (ICIQ) to compare the patient's degree of improvement. Alternatively, the Patient's Global Impression of Improvement (PGI-I score) with an inherent before-after assessment has been widely accepted in recent studies...

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

    DEFF Research Database (Denmark)

    Høgh, A; Lindholt, J S; Nielsen, H;

    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....

  4. Inconsistent reporting of surrogate outcomes in randomised clinical trials: cohort study

    DEFF Research Database (Denmark)

    La Cour, Jeppe Lerche; Brok, Jesper; Gøtzsche, Peter C

    2010-01-01

    To assess if authors of randomised clinical trials convey the fact that they have used surrogate outcomes and discussed their validity.......To assess if authors of randomised clinical trials convey the fact that they have used surrogate outcomes and discussed their validity....

  5. Developing a Valid Patient-Reported Outcome Measure

    OpenAIRE

    Rothrock, NE; Kaiser, KA; Cella, D

    2011-01-01

    Many aspects of patients’ experiences with illness, medication, and health care are best captured from patient-reported outcomes (PROs). In this article, we describe the process for constructing quality PRO instruments, from conceptual model development through instrument validation. We also discuss PROs as clinical trial end points and the potential of PRO data for aiding clinicians and patients in choosing from among multiple therapeutic options. Finally, we provide an overview of some exis...

  6. Entanglement-assisted guessing of complementary measurement outcomes

    OpenAIRE

    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 is entangled to the measured one; indeed, the seminal paper of Einstein, Podolsky, and Rosen (EPR) showed that maximal entanglement allows Bob to perfectly win this guessing game. Although not in co...

  7. Two-year radiographic and clinical outcomes from the Canadian Methotrexate and Etanercept Outcome study in patients with rheumatoid arthritis

    OpenAIRE

    Keystone, Edward C.; Pope, Janet E.; Thorne, J. Carter; Poulin-Costello, Melanie; Phan-Chronis, Krystene; Vieira, Andrew; Haraoui, Boulos

    2015-01-01

    Objective. To evaluate radiographic and clinical outcomes up to 24 months in patients with RA enrolled in the Canadian Methotrexate and Etanercept Outcome study. Methods. In this open-label non-inferiority trial, patients with inadequate response to MTX received etanercept plus MTX for 6 months and then were randomized to either etanercept monotherapy or continued etanercept plus MTX until 24 months. Radiographic data were analysed using the modified total Sharp score (mTSS), joint space narr...

  8. Testing for heterogeneity among the components of a binary composite outcome in a clinical trial

    OpenAIRE

    Devereaux PJ; Thabane Lehana; Pogue Janice; Yusuf Salim

    2010-01-01

    Abstract Background Investigators designing clinical trials often use composite outcomes to overcome many statistical issues. Trialists want to maximize power to show a statistically significant treatment effect and avoid inflation of Type I error rate due to evaluation of multiple individual clinical outcomes. However, if the treatment effect is not similar among the components of this composite outcome, we are left not knowing how to interpret the treatment effect on the composite itself. G...

  9. Brucellosis in pregnancy: clinical aspects and obstetric outcomes

    Directory of Open Access Journals (Sweden)

    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.

  10. Prediction of labor induction outcome using different clinical parameters

    Directory of Open Access Journals (Sweden)

    Tatić-Stupar Žaklina

    2013-01-01

    Full Text Available Introduction. Induction of labor is one of the most common obstetric interventions in contemporary obstetrics. Objective. The aim of the study was to evaluate the clinical and sonographic parameters in prediction of success of labor induction. Methods. The prospective study included 422 women in whom induction of labor was carried out at the Department of Obstetrics and Gynecology of Clinical Centre of Vojvodina. The role of body mass index and age of women, parity Bishop score, cervical length measured by transvaginal ultrasound was evaluated in regard of the success of induction, which was considered successful if a vaginal delivery occurred within 24 hours after the onset of induction. Data were statistically analyzed by univariate statistical analysis and Pearson’s χ2 test. Results. Out of 422 women, induction of labor was successful in 356 (84.4%, and it failed in 66 (15.6% cases. The values of Bishop score and cervical length had positive correlation with the success of induction. Conclusion. Bishop score and transvaginal cervical length were both reliable predictors in determining the success of labor induction, as well as parity and BMI. These parameters are mostly complementary, not competitive in prediction of labor induction success.

  11. Improving the science of health informatics by using validated instruments and outcome measures

    OpenAIRE

    Scott, Philip; Brown, Angela W.; Friedman, Charles P; Wyatt, Jeremy C; Georgiou, Andrew; Eisenstein, Eric L.

    2014-01-01

    Health informatics does not have well-established instruments and outcome variables to measure efficacy and effectiveness. We report on a structured literature review of measurement practice in the evaluation of clinical decision support systems. A series of brief presentations introduces a workshop session about how to influence methodological practice in the field. We aim to elicit and elaborate suggestions for how to achieve the validation of at least a core set of health informatics measu...

  12. Assessment of murine lung mechanics outcome measures: alignment with those made in asthmatics

    OpenAIRE

    Walker, Julia K. L.; Kraft, Monica; Fisher, John T

    2013-01-01

    Although asthma is characterized as an inflammatory disease, recent reports highlight the importance of pulmonary physiology outcome measures to the clinical assessment of asthma control and risk of asthma exacerbation. Murine models of allergic inflammatory airway disease have been widely used to gain mechanistic insight into the pathogenesis of asthma; however, several aspects of murine models could benefit from improvement. This review focuses on aligning lung mechanics measures made in mi...

  13. Prioritising outcomes measures for ambulance service care: a three stage consensus study

    OpenAIRE

    Coster, Joanne; Turner, Janette; Siriwardena, A Niroshan; Wilson, Richard; Phung, Viet-Hai

    2013-01-01

    Background Historically ambulance care quality and performance has been measured by response times rather than clinical need or effectiveness. This limits the evidence about the effectiveness of the care the ambulance service provides. The Pre-hospital Outcomes for Evidence Based Evaluation (PhOEBE) project is a 5 year research programme which aims to develop new ways of measuring the performance, quality and impact of ambulance service care that better reflect the care provided. Meth...

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

    Directory of Open Access Journals (Sweden)

    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

  15. 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......) assess the need for de-learning existing knowledge (i.e., cleaning the slate), and (3) be able to set up challenging yet fair exams for the total student body. Assessing learning outcomes for the purpose of knowledge management plays a major role in accounting firms too. Knowledge transfer among auditors...

  16. 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......) assess the need for de-learning existing knowledge (i.e., cleaning the slate), and (3) be able to set up challenging yet fair exams for the total student body. Assessing learning outcomes for the purpose of knowledge management plays a major role in accounting firms too. Knowledge transfer among auditors...

  17. Measuring patient satisfaction in sexually transmitted infection clinics: a systematic review

    OpenAIRE

    Weston, Rachel L; Dabis, Rasha; Ross, Jonathan

    2009-01-01

    Abstract Objectives Measuring patient satisfaction is an important aspect of making services attractive to patients and improving service delivery, and outpatient based clinics are increasingly assessing service quality using patient based outcome measures. No systematic review of patient satisfaction in sexually transmitted infection clinics has previously been performed. The objectives of the review were: ? To establish how patient satisfaction with sexual health servic...

  18. Measuring patient knowledge of asthma: a systematic review of outcome measures.

    NARCIS (Netherlands)

    Pink, J.; Pink, K.; Elwyn, G.

    2009-01-01

    BACKGROUND: Asthma self-management education is a key component of international guidelines. No gold standard patient centred outcome measure exists for asthma knowledge. Our aim was to identify high-quality, validated, and reliable outcome measures suitable for use in either the research or clinica

  19. Individual risk alleles of susceptibility to schizophrenia are associated with poor clinical and social outcomes.

    Science.gov (United States)

    Sakamoto, Shinji; Takaki, Manabu; Okahisa, Yuko; Mizuki, Yutaka; Inagaki, Masatoshi; Ujike, Hiroshi; Mitsuhashi, Toshiharu; Takao, Soshi; Ikeda, Masashi; Uchitomi, Yosuke; Iwata, Nakao; Yamada, Norihito

    2016-04-01

    Many patients with schizophrenia have poor clinical and social outcomes. Some risk alleles closely related to the onset of schizophrenia have been reported to be associated with their clinical phenotypes, but the direct relationship between genetic vulnerability to schizophrenia and clinical/social outcomes of schizophrenia, as evaluated by both practical clinical scales and 'real-world' function, has not been investigated. We evaluated the clinical and social outcomes of 455 Japanese patients with schizophrenia by severity of illness according to the Clinical Global Impression-Severity Scale (CGI-S) and social outcomes by social adjustment/maladjustment at 5 years after the first visit. We examined whether 46 single nucleotide polymorphisms (SNPs) selected from a Japanese genome-wide association study of susceptibility to schizophrenia were associated with clinical and social outcomes. We also investigated the polygenic risk scores of 46 SNPs. Allele-wise association analysis detected three SNPs, including rs2623659 in the CUB and Sushi multiple domains-1 (CSMD1) gene, associated with severity of illness at end point. The severity of illness at end point was associated with treatment response, but not with the severity of illness at baseline. Three SNPs, including rs2294424 in the C6orf105 gene, were associated with social outcomes. Point estimates of odds ratios showed positive relationships between polygenic risk scores and clinical/social outcomes; however, the results were not statistically significant. Because these results are exploratory, we need to replicate them with a larger sample in a future study. PMID:26674612

  20. Outcome instruments to measure frailty: a systematic review

    NARCIS (Netherlands)

    Vries, N.M. de; Staal, J.B.; Ravensberg, C.D. van; Hobbelen, J.S.; Olde Rikkert, M.G.M.; Nijhuis-Van der Sanden, M.W.G.

    2011-01-01

    Frailty is one of the greatest challenges for healthcare professionals. The level of frailty depends on several interrelated factors and can change over time while different interventions seem to be able to influence the level of frailty. Therefore, an outcome instrument to measure frailty with soun

  1. Conceptualizing Outcome and Impact Measures for Intelligence Services

    Science.gov (United States)

    Gainor, Rhiannon; Bouthillier, France

    2014-01-01

    Introduction: The purpose of this qualitative, exploratory study is to clarify ambiguous concepts in intelligence services literature specifically related to measurement of intelligence outcomes and impact. Method: Face to face interviews were held with five subject experts from various intelligence fields and countries regarding their…

  2. Lipocalin-2 as an Infection-Related Biomarker to Predict Clinical Outcome in Ischemic Stroke

    Science.gov (United States)

    Hochmeister, Sonja; Engel, Odilo; Adzemovic, Milena Z.; Pekar, Thomas; Kendlbacher, Paul; Zeitelhofer, Manuel; Haindl, Michaela; Meisel, Andreas; Fazekas, Franz; Seifert-Held, Thomas

    2016-01-01

    Objectives From previous data in animal models of cerebral ischemia, lipocalin-2 (LCN2), a protein related to neutrophil function and cellular iron homeostasis, is supposed to have a value as a biomarker in ischemic stroke patients. Therefore, we examined LCN2 expression in the ischemic brain in an animal model and measured plasma levels of LCN2 in ischemic stroke patients. Methods In the mouse model of transient middle cerebral artery occlusion (tMCAO), LCN2 expression in the brain was analyzed by immunohistochemistry and correlated to cellular nonheme iron deposition up to 42 days after tMCAO. In human stroke patients, plasma levels of LCN2 were determined one week after ischemic stroke. In addition to established predictive parameters such as age, National Institutes of Health Stroke Scale and thrombolytic therapy, LCN2 was included into linear logistic regression modeling to predict clinical outcome at 90 days after stroke. Results Immunohistochemistry revealed expression of LCN2 in the mouse brain already at one day following tMCAO, and the amount of LCN2 subsequently increased with a maximum at 2 weeks after tMCAO. Accumulation of cellular nonheme iron was detectable one week post tMCAO and continued to increase. In ischemic stroke patients, higher plasma levels of LCN2 were associated with a worse clinical outcome at 90 days and with the occurrence of post-stroke infections. Conclusions LCN2 is expressed in the ischemic brain after temporary experimental ischemia and paralleled by the accumulation of cellular nonheme iron. Plasma levels of LCN2 measured in patients one week after ischemic stroke contribute to the prediction of clinical outcome at 90 days and reflect the systemic response to post-stroke infections. PMID:27152948

  3. 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.

  4. Impact of clinical severity on outcomes of mentalisation-based treatment for borderline personality disorder

    OpenAIRE

    Bateman, A; Fonagy, P.

    2013-01-01

    Objective – Evidence of remission without specialized treatment for BPD is accumulating. The authors investigated whether specialized treatments are particularly indicated for patients at high levels of clinical severity. They examined the impact of clinical severity on outcomes of a randomized controlled trial of mentalization-based treatment (MBT) contrasted with supportive clinical management (SCM). Method – 134 patients were randomly allocated to MBT or SCM. The primary outcome was the ab...

  5. Pain relief and clinical outcome: from opioids to balanced analgesia

    DEFF Research Database (Denmark)

    Kehlet, H

    1996-01-01

    If it is generally accepted that adequate postoperative pain relief will improve outcome from surgery, several controlled trials demonstrated this only for lower body surgical procedures with epidural and spinal anesthetics. Important effects on outcome were not shown when postoperative opioids...... were administered with patient controlled (PCA) or epidural techniques. However, the most optimal pain relief seems to be best achieved with balanced analgesia techniques using combinations of epidural opioids and local anesthetics and systemic non-steroidal antiinflammatory drugs. Future efforts...

  6. IBADAN KNEE/HIP OSTEOARTHRITIS OUTCOME MEASURE: PROCESS OF DEVELOPMENT

    OpenAIRE

    A.C. Odole; Odunaiya, N A; Akinpelu, A.O

    2013-01-01

    The development of instruments for the assessment of therapeutic intervention has been an age long practice. However, many of the published instruments do not have detailed information on how the instruments were developed. It is necessary for authors to provide detailed (step by step) information on how measuring scales/instruments are developed. The Ibadan Knee/Hip Osteoarthritis Outcome Measure (IKHOAM) was developed as a Nigerian-environment and culture-friendly instrument for the assessm...

  7. OMERACT: An international initiative to improve outcome measurement in rheumatology

    OpenAIRE

    Simon Lee; Brooks Peter; Boers Maarten; Tugwell Peter; Strand Vibeke; Idzerda Leanne

    2007-01-01

    Abstract OMERACT is the acronym for an international, informally organized network initiated in 1992 aimed at improving outcome measurement in rheumatology. Chaired by an executive committee, it organizes consensus conferences in a 2-yearly cycle that circles the globe. Data driven recommendations are prepared and updated by expert working groups. Recommendations include core sets of measures for most of the major rheumatologic conditions. Since 2002 patients have been actively engaged in the...

  8. 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." PMID:9601411

  9. 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. PMID:18509683

  10. Medical specialty boards can help measure graduate medical education outcomes.

    Science.gov (United States)

    Peterson, Lars E; Carek, Peter; Holmboe, Eric S; Puffer, James C; Warm, Eric J; Phillips, Robert L

    2014-06-01

    U.S. graduate medical education (GME) training institutions are under increasing scrutiny to measure program outcomes as a demonstration of accountability for the sizeable funding they receive from the federal government. The Accreditation Council for Graduate Medical Education (ACGME) is a potential agent of measuring GME accountability but has no interaction with physicians after residency training is completed. American Board of Medical Specialty (ABMS) member boards interact with physicians throughout their careers through maintenance of certification (MOC) and are a potential source of valuable data on physician competency and quality of care, both of which could be used to measure GME accountability.The authors propose that ABMS boards and the ACGME deepen their existing relationship to better assess residency training outcomes. ABMS boards have a wealth of data on physicians collected as a by-product of MOC and business operations. Further, many ABMS boards collect practice demographics and scope-of-practice information through MOC enrollment surveys or recertification examination questionnaires. These data are potentially valuable in helping residencies know what their graduates are doing in practice. Part 4 of MOC generally involves assessment of the quality of care delivered in practice, and ABMS boards could share these deidentified data with the ACGME and residency programs to provide direct feedback on the practice outcomes of graduates.ABMS member boards and the ACGME should broaden their long-standing relationship to further develop shared roles and data-sharing mechanisms to better inform residencies and the public about GME training outcomes. PMID:24871232

  11. Admissions to acute adolescent psychiatric units: a prospective study of clinical severity and outcome

    Directory of Open Access Journals (Sweden)

    Jensen Gunnar

    2011-01-01

    Full Text Available Abstract Background Several countries have established or are planning acute psychiatric in-patient services that accept around-the-clock emergency admission of adolescents. Our aim was to investigate the characteristics and clinical outcomes of a cohort of patients at four Norwegian units. Methods We used a prospective pre-post observational design. Four units implemented a clinician-rated outcome measure, the Health of the Nation Outcome Scales for Children and Adolescents (HoNOSCA, which measures mental health problems and their severity. We collected also data about the diagnoses, suicidal problems, family situations, and the involvement of the Child Protection Service. Predictions of outcome (change in HoNOSCA total score were analysed with a regression model. Results The sample comprised 192 adolescents admitted during one year (response rate 87%. Mean age was 15.7 years (range 10-18 and 70% were girls. Fifty-eight per cent had suicidal problems at intake and the mean intake HoNOSCA total score was 18.5 (SD 6.4. The largest groups of main diagnostic conditions were affective (28% and externalizing (26% disorders. Diagnoses and other patient characteristics at intake did not differ between units. Clinical psychiatric disorders and developmental disorders were associated with severity (on HoNOSCA at intake but not with outcome. Of adolescents ≥ 16 years, 33% were compulsorily admitted. Median length of stay was 8.5 days and 75% of patients stayed less than a month. Compulsory admissions and length of stay varied between units. Mean change (improvement in the HoNOSCA total score was 5.1 (SD 6.2, with considerable variation between units. Mean discharge score was close to the often-reported outpatient level, and self-injury and emotional symptoms were the most reduced symptoms during the stay. In a regression model, unit, high HoNOSCA total score at intake, or involvement of the Child Protection Service predicted improvement during admission

  12. Impact of clinical pharmacy services on renal transplant recipients’ adherence and outcomes

    OpenAIRE

    Chisholm-Burns, Marie A.; Spivey, Christina A.; Garrett, Charlene; McGinty, Herbert; Mulloy, Laura L

    2008-01-01

    The purpose of this article is to provide a description of a clinical pharmacy services program implemented in a renal transplant clinic to improve medication access and adherence as well as health and economic outcomes among renal transplant recipients (RTRs). Following a team-based planning process and an informal survey of RTRs, a clinical pharmacy service intervention was implemented in the Medical College of Georgia renal transplant clinic. As part of the intervention, a clinical pharmac...

  13. 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

    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......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...... 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...

  14. Clinical outcome of gliosarcoma compared with glioblastoma multiforme: a clinical study in Chinese patients.

    Science.gov (United States)

    Zhang, Guobin; Huang, Shengyue; Zhang, Junting; Wu, Zhen; Lin, Song; Wang, Yonggang

    2016-04-01

    Gliosarcoma (GSM) is a rare biphasic neoplasms of the central nervous system composed of a glioblastoma multiforme (GBM) admixed with a sarcomatous component. In clinical practice GSM is generally managed similarly to GBM. However, there are conflicting reports regarding their clinical aggressiveness, cell line of origin and possible prognosis compared with those of GBM. The objective of this study was to compare clinic-pathological features in GSM patients with the GBM patients during the same study period. 518 patients with GBM were treated at our hospital between 2008 and 2013, among them 51 were GSM. In this series the GSMs represented 9.8 % of all GBMs and included 58.8 % male with a median age of 44.7 years. The locations, all supratentorial, included temporal in 41.2 %, frontal in 25.5 %, parietal in 19.6 %, and occipital in 13.7 %. All patients underwent tumor resection followed by post-operative radiation and adjuvant chemotherapy. The O6-methylguanine-DNA methyltransferase promoter methylation studies were significantly more frequent in the GBMs than GSMs (80.1 % vs. 44.7 %, P GSM were 8.0 and 13.0 months, respectively, as compared with 9.0 and 14.0 months in the GBM group (log rank test P = 0.001 and 0.004, respectively). The Cox proportional hazards regression model indicated that the extent of tumor resection (HR = 1.518, P = 0.009) and pathological types (HR = 0.608, P = 0.002) were the significant prognostic factors in our own series. With regard to clinical features and outcomes, GSM and GBM cannot be distinguished clinically. GSM in China may be managed similarly to GBM, with maximal safe surgical resection followed by chemo-radiotherapy. Our study adds further evidence to support GSM as a unique clinical entity with a likely worse prognosis than GBM. PMID:26725096

  15. Shared Medical Appointments: Impact on Clinical and Quality Outcomes in Veterans With Diabetes.

    Science.gov (United States)

    Harris, Marianne D; Kirsh, Susan; Higgins, Patricia A

    2016-01-01

    Managing diabetes poses substantial challenges to the over 29.1 million Americans afflicted, and is financially overwhelming to the US health care system. One potential strategy is utilizing a group approach to care delivery or shared medical appointment (SMA). The purpose of this 3-year retrospective VA study was to investigate differences in clinical and quality outcome measures in veterans with type 2 diabetes who used SMAs and those who received only usual care (UC) one-on-one with their doctor. This observational, 2-group cohort study used abstracted medical records from a large Midwestern Veterans Administration hospital. Clinical outcome metrics included hemoglobin A1c (hbA1c), systolic blood pressure, low-density lipoprotein cholesterol, and emergency department (ED) visits. Quality outcomes included Veterans' Administration (VA) Department of Defense clinical practice guidelines for the management of diabetes. A total of 988 total VA cases were examined retrospectively over 3 years: 371 cases had used SMAs and 617 were in the UC cohort, and had never attended a diabetes SMA. The study period used abstracted VA medical records from 2008 to 2010. There were no statistically significant differences in HbA1c, systolic blood pressure, and ED visits between groups; however, hbA1c for individuals who attended SMAs was 8.55 (standard deviation [SD] = 1.72) and UC was 7.49 (SD = 1.28) (P inhibitors (ACE-I). SMAs may provide a venue for assessing and delivering quality care for patients with type 2 diabetes. More research is needed to ascertain effective strategies for diabetes disease management in high-risk patients. PMID:27367218

  16. 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

  17. Do SF-36 summary scores work as outcome measures in chronic functional disorders?

    DEFF Research Database (Denmark)

    Schröder, Andreas; Ørnbøl, Eva; Fink, Per

    Background SF-36 Physical and Mental Component Summaries (PCS and MCS) are increasingly used as main measures of outcome in clinical trials. Yet, studies in different patient populations have demonstrated serious problems in interpreting these summary scores. We are conducting a randomised contro...... with interacting physical and mental health problems. One may benefit from using other scoring methods such as the RAND-36 HSI to validate the results.......Background SF-36 Physical and Mental Component Summaries (PCS and MCS) are increasingly used as main measures of outcome in clinical trials. Yet, studies in different patient populations have demonstrated serious problems in interpreting these summary scores. We are conducting a randomised...... controlled trial on cognitive behavioural therapy in patients with severe and chronic functional disorders. Based on a pilot study and baseline data, we have assessed the performance of the summary scores. Aim To demonstrate problems in the orthogonal factor solution for PCS and MCS and to assess other...

  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. 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.

  20. 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

  1. Clinical audit of foetomaternal outcome in pregnancies with fibroid uterus

    International Nuclear Information System (INIS)

    Background: Leiomyoma, myoma, leiomyoma or fibroids are synonymous terms. They may be present in as many as 1 in 5 women over age 35 years. If pregnancy is associated with fibroids, it leads to multiple complications. Objectives of this study were to evaluate the maternal and foetal outcome in women having pregnancy with fibroids in uterus and the complications associated with fibroids during the pregnancy. Methods: This descriptive study was conducted in the Department of Obstetrics and Gynaecology, Ayub Teaching Hospital Abbottabad from March 2009 to March 2010. Data were collected on proforma regarding demographic variables, obstetrical history, mode of delivery, maternal outcome, maternal complications, and foetal outcome. Mean and standard deviation was calculated for age, period of gestation, and obstetrical history. Frequency and percentages was calculated for booking status, maternal outcome, maternal complications and foetal outcome. Results: Thirty patients were included in this study who had pregnancy with fibroid. Normal delivery was achieved in 14 (46.66%) patients. Eight (26.67%) patients had caesarean section and eight (26.67%) had miscarriages. Seven (23.33%) patients had no complications while 8 (26.67%) had miscarriages, 8 (26.67%) had postpartum haemorrhage, 10 (33.33%) had preterm delivery, and 3 patients had ante-partum haemorrhage. Two (10%) patients had premature rupture off membranes and 1 patient (3.33%) had pain abdomen and technical difficulty during caesarean section. There were 12 (40%) healthy babies. Five (16.67%) babies delivered with morbidity but recovered. There were 4 (13.33%) intrauterine deaths and one early neonatal death. Conclusion: Fibroid in pregnancy, especially multiple intramural fibroids and fibroids larger than 10 Cm, cause miscarriage and preterm labour. (author)

  2. Development and Validation of the Keele Musculoskeletal Patient Reported Outcome Measure (MSK-PROM)

    OpenAIRE

    Hill, JC; Thomas, E.; Hill, S.; Foster, NE; van der Windt, DA

    2015-01-01

    OBJECTIVE: To develop and validate a patient report outcome measure (PROM) for clinical practice that can monitor health status of patients with a range of musculoskeletal (MSK) disorders. METHODS: Constructs for inclusion in the MSK-PROM were identified from a consensus process involving patients with musculoskeletal conditions, clinicians, purchasers of healthcare services, and primary care researchers. Psychometric properties of the brief tool, including face and construct validity, repeat...

  3. Development and Validation of the Keele Musculoskeletal Patient Reported Outcome Measure (MSK-PROM)

    OpenAIRE

    Hill, Jonathan C.; Elaine Thomas; Susan Hill; Foster, Nadine E; van der Windt, Danielle A.

    2015-01-01

    Objective To develop and validate a patient report outcome measure (PROM) for clinical practice that can monitor health status of patients with a range of musculoskeletal (MSK) disorders. Methods Constructs for inclusion in the MSK-PROM were identified from a consensus process involving patients with musculoskeletal conditions, clinicians, purchasers of healthcare services, and primary care researchers. Psychometric properties of the brief tool, including face and construct validity, repeatab...

  4. Impact of clinical registries on quality of patient care and health outcomes: protocol for a systematic review

    Science.gov (United States)

    Hoque, Dewan Md Emdadul; Kumari, Varuni; Ruseckaite, Rasa; Romero, Lorena; Evans, Sue M

    2016-01-01

    Introduction Many developed countries have regional and national clinical registries aimed at improving health outcomes of patients diagnosed with particular diseases or cared for in particular healthcare settings. Clinical quality registries (CQRs) are clinical registries established with the purpose of monitoring quality of care and providing feedback to improve health outcomes. The aim of this systematic review is to understand the impact of CQRs on (1) mortality/survival; (2) measures of outcome that reflect a process or outcome of healthcare; (3) healthcare utilisation and (4) costs. Methods and analysis The PRISMA-P methodology, checklist and standard strategy using predefined inclusion and exclusion criteria and structured data abstraction tools will be followed. A search of the electronic databases MEDLINE, EMBASE, Cochrane Central Register of Controlled Trials (CENTRAL) and CINAHL will be undertaken, in addition to Google Scholar and grey literature, to identify studies in English covering the period January 1980 to December 2014. Case–control, cohort, randomised controlled trials and controlled clinical trials which describe the registry as an intervention will be eligible for inclusion. Narrative synthesis of study findings will be conducted, guided by a conceptual framework developed to analyse the outcome measure of the registry using defined criteria. If sufficient studies are identified with a similar outcome of interest and measure using the same comparator and time of interval, results will be pooled for random-effects meta-analysis. Test for heterogeneity and sensitivity analysis will be conducted. To identify reporting bias, forest plots and funnel plots will be created and, if required, Egger's test will be conducted. Ethics and dissemination Ethical approval is not required as primary data will not be collected. Review results will be published as a part of thesis, peer-reviewed journal and conferences. Trial registration number CRD

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

    International Nuclear Information System (INIS)

    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. 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.

  7. Measures in forensic psychiatry : Risk monitoring and structured outcome assessment

    OpenAIRE

    Sturidsson, Knut

    2007-01-01

    Background: Violent offenders suffering from a major mental disorder (MMD) are sometimes publicly portrayed as particularly dangerous. In reality however, only a small fraction of those inflicted with a MMD do commit any violent offence. The present thesis focuses on means to monitor risk of violence and to some extent measure the content and outcome of forensic psychiatric care. The overall aim of this thesis was to investigate forensic psychiatric risk assessments from a b...

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

    OpenAIRE

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

    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 ...

  9. Health Beliefs and Culture: Essential Considerations for Outcome Measurement

    OpenAIRE

    Kamaldeep Bhui; Sokratis Dinos

    2008-01-01

    Culture is linked to the way emotions, mental distress, social problems, and physical illness are perceived, experienced, and expressed. Beliefs about what constitutes illness and what can be done about it vary considerably across cultures. Defining mental health and measuring mental health outcomes have been the focus of academics and mental health professionals across a number of disciplines from psychiatry and psychology to anthropology and sociology. Mental health diagnostic constructs an...

  10. D-outcome measurement for a nonlocality test

    OpenAIRE

    Son, W.; Lee, Jinhyoung; Kim, M. S.

    2003-01-01

    For the purpose of the nonlocality test, we propose a general correlation observable of two parties by utilizing local $d$-outcome measurements with SU($d$) transformations and classical communications. Generic symmetries of the SU($d$) transformations and correlation observables are found for the test of nonlocality. It is shown that these symmetries dramatically reduce the number of numerical variables, which is important for numerical analysis of nonlocality. A linear combination of the co...

  11. Clinical Outcomes of Conservative Treatment and Arthroscopic Repair of Rotator Cuff Tears: A Retrospective Observational Study

    Science.gov (United States)

    Lee, Woo Hyung; Do, Hyun Kyung; Lee, Joong Hoon; Kim, Bo Ram; Noh, Jee Hyun; Choi, Soo Hyun; Chung, Sun Gun; Lee, Shi-Uk; Choi, Ji Eun; Kim, Seihee; Kim, Min Jee

    2016-01-01

    Objective To compare the clinical outcomes following conservative treatment and arthroscopic repair in patients with a rotator cuff tear. Methods In this retrospective study, patients aged >50 years with a symptomatic rotator cuff tear were reviewed. The rotator cuff tendons were evaluated using ultrasonography, shoulder magnetic resonance imaging or MR arthrography, and the patients with either a high-grade partial-thickness or small-to-medium-sized (≤3 cm) full-thickness tear were included in this study. The primary outcome measures were a pain assessment score and range of motion (ROM) at 1-year follow-up. The secondary outcomes were the rate of tear progression or retear along with the rate of symptom aggravation after the treatments. Results A total of 357 patients were enrolled, including 183 patients that received conservative treatment and 174 patients who received an arthroscopic repair. The pain assessment score (p50 years old with a less than medium-sized rotator cuff tear in a 1-year follow-up period. Further study is warranted to find the optimal combination of conservative treatment for a symptomatic rotator cuff tear. PMID:27152275

  12. The correlation between the duration of sciatica and clinical outcome after lumbar discectomy

    Directory of Open Access Journals (Sweden)

    Hossein Mashhadinezhad

    2015-06-01

    Conclusion: Patients with less than three months of sciatica may seem to enjoy a better clinical outcome after one year, there could be found no correlation between the duration of sciatica and the satisfaction after two years.

  13. Clinical outcomes of a 2-y soy isoflavone supplementation in menopausal women1234

    OpenAIRE

    Steinberg, Francene M; Michael J. Murray; Lewis, Richard D.; Cramer, Margaret A; Amato, Paula; Young, Ronald L.; Barnes, Stephen; Konzelmann, Karen L; Fischer, Joan G; Ellis, Kenneth J; Shypailo, Roman J.; Fraley, J Kennard; Smith, E. O'Brian; Wong, William W.

    2010-01-01

    Background: Soy isoflavones are naturally occurring phytochemicals with weak estrogenic cellular effects. Despite numerous clinical trials of short-term isoflavone supplementation, there is a paucity of data regarding longer-term outcomes and safety.

  14. 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

  15. 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

  16. Long-term clinical outcome after alcohol septal ablation for obstructive hypertrophic cardiomyopathy

    DEFF Research Database (Denmark)

    Veselka, Josef; Jensen, Morten Kvistholm; Liebregts, Max;

    2016-01-01

    AIMS: The first cases of alcohol septal ablation (ASA) for obstructive hypertrophic cardiomyopathy (HCM) were published two decades ago. Although the outcomes of single-centre and national ASA registries have been published, the long-term survival and clinical outcome of the procedure are still...

  17. Prediction of labor induction outcome using different clinical parameters

    OpenAIRE

    Tatić-Stupar Žaklina; Novakov-Mikić Aleksandra; Bogavac Mirjana; Milatović Stevan; Sekulić Slobodan

    2013-01-01

    Introduction. Induction of labor is one of the most common obstetric interventions in contemporary obstetrics. Objective. The aim of the study was to evaluate the clinical and sonographic parameters in prediction of success of labor induction. Methods. The prospective study included 422 women in whom induction of labor was carried out at the Department of Obstetrics and Gynecology of Clinical Centre of Vojvodina. The role of body mass index and age of women...

  18. Measurements of body protein for clinical investigation

    International Nuclear Information System (INIS)

    Body protein (nitrogen) is determined by bilaterally irradiating the body with neutrons using Pu-Be sources and measuring the resultant 10.8 MeV gamma rays from the reaction 14N(n,8) 15N. In the authors lab the whole body can be scanned or separate segments of the body can be measured independently. A nitrogen index has been developed based on body size and is used as a predictor of normal total body nitrogen (TBN). They have found that TBN, when normalized to body size in this way, provides a reliable index of protein status which cannot be accurately determined by body weight, anthropometry, or body potassium measurements. Changes in body composition with age were studied by measuring the composition of 56 healthy female volunteers aged 20-80. Measurements were made for K(40K), Ca and N. It was shown that protein and bone mineral decrease with age but that this is not reflected in K or anthropometry measurements. Results of other studies to be presented include: body protein measurements pre and post TPN (total parenteral nutrition), nutritional status of patients on long term CAPD (continuous ambulatory peritoneal dialysis) and changes in body composition as a result of TPN in patients with small cell lung cancer receiving chemotherapy. Clinical results show that indirect measurements of body protein based on weight, potassium, or anthropometry, do not give an accurate measure of body protein. For an accurate measurement, direct measurement of body protein is necessary

  19. Clinical outcomes following salvage Gamma Knife radiosurgery for recurrent glioblastoma

    OpenAIRE

    Larson, Erik W.; Peterson, Halloran E.; Lamoreaux, Wayne T.; Mackay, Alexander R.; Fairbanks, Robert K; Call, Jason A.; Carlson, Jonathan D.; Ling, Benjamin C; Demakas, John J.; Cooke, Barton S; Lee, Christopher M

    2014-01-01

    Glioblastoma multiforme (GBM) is the most common malignant primary brain tumor with a survival prognosis of 14-16 mo for the highest functioning patients. Despite aggressive, multimodal upfront therapies, the majority of GBMs will recur in approximately six months. Salvage therapy options for recurrent GBM (rGBM) are an area of intense research. This study compares recent survival and quality of life outcomes following Gamma Knife radiosurgery (GKRS) salvage therapy. Following a PubMed search...

  20. 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. PMID:24891572

  1. Relationship between Angiographic Late Loss and 5-Year Clinical Outcome after Drug-Eluting Stent Implantation

    OpenAIRE

    Yang, Young-June; Shin, Sanghoon; Kim, Byeong-Keuk; Kim, Jung-Sun; Shin, Dong-Ho; Ko, Young-Guk; Choi, Donghoon; Jang, Yangsoo; Hong, Myeong-Ki

    2012-01-01

    Purpose Currently, insufficient data exist to evaluate the relationship between angiographic late loss (LL) and long-term clinical outcome after drug-eluting stent (DES) implantation. In this study, we hypothesized that angiographic LL between 0.3 and 0.6 mm correlate with favorable long-term clinical outcomes. Materials and Methods Patients were enrolled in the present study if they had undergone both DES implantation in single coronary vessel and a subsequent follow-up angiogram (n=634). Th...

  2. Midterm survivorship and clinical outcome of INDUS knee prosthesis: 5 year followup study

    OpenAIRE

    Sancheti, Kantilal H; Sancheti, Parag K; Rajeev S Joshi; Kailash R Patil; Shyam, Ashok K; Bhaskar, Raja R

    2016-01-01

    Background: INDUS knee implant has been designed as per the anatomical morphology of the Indian population and has shown good clinical outcome in short term studies. The purpose of the present study was to report the midterm survivorship and clinical outcome of this implant. Materials and Methods: Two hundred and twenty three primary total knee arthroplasties in 209 consecutive patients using the INDUS knee prosthesis were prospectively enrolled. There were 145 females (155 knees) and 64 male...

  3. Clinical Profile and Outcome of Japanese Encephalitis in Children Admitted with Acute Encephalitis Syndrome

    OpenAIRE

    Gitali Kakoti; Prafulla Dutta; Bishnu Ram Das; Jani Borah; Jagadish Mahanta

    2013-01-01

    Japanese encephalitis (JE) is an arthropod borne viral disease. Children are most commonly affected in Southeast Asian region showing symptoms of central nervous system with several complications and death. The clinical characteristics and outcomes in pediatric JE patients hospitalized with acute encephalitis syndrome (AES) are still poorly understood. A prospective study was conducted in pediatric ward of Assam Medical College Hospital to evaluate the clinical profile and outcome of JE in ch...

  4. Dimensions of socioeconomic status and clinical outcome after primary percutaneous coronary intervention

    DEFF Research Database (Denmark)

    Jakobsen, Lars; Niemann, Troels; Thorsgaard, Niels;

    2012-01-01

    The association between low socioeconomic status (SES) and high mortality from coronary heart disease is well-known. However, the role of SES in relation to the clinical outcome after primary percutaneous coronary intervention remains poorly understood.......The association between low socioeconomic status (SES) and high mortality from coronary heart disease is well-known. However, the role of SES in relation to the clinical outcome after primary percutaneous coronary intervention remains poorly understood....

  5. 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.

  6. 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. PMID:26703412

  7. Clinical Characteristics and Outcomes of Cardiomyopathy in Barth Syndrome: The UK Experience.

    Science.gov (United States)

    Kang, Sok-Leng; Forsey, Jonathan; Dudley, Declan; Steward, Colin G; Tsai-Goodman, Beverly

    2016-01-01

    Barth syndrome (BTHS) is an X-linked disorder characterised by cardiomyopathy, neutropenia, skeletal myopathy and growth delay. This study describes the UK national clinical experience and outcome of cardiomyopathy in BTHS. The clinical course and echocardiographic changes of all patients with BTHS in the UK were reviewed from 2004 to 2014. In addition, strain analysis using 2D speckle tracking echocardiography was performed to further assess left ventricular function in the most recent follow-up. At last follow-up, 22 of 27 patients were alive with a median age of 12.6 (2.0-23.8) years; seven underwent cardiac transplantation at a median age of 2 (0.33-3.6) years, and five died (18.5 %) at a median age of 1.8 (0.02-4.22) years. All deaths were related to cardiomyopathy or its management. Left ventricular diastolic dimension and systolic function measured by fractional shortening tended to normalise and stabilise after the first 3 years of life in the majority of patients. However, patients with BTHS (n = 16) had statistically significant reduction in global longitudinal and circumferential strain compared to controls (n = 18), (p < 0.001), despite apparent normal conventional measures of function. There was also reduced or reversed apical rotation and reduced left ventricular twist. Sustained ventricular arrhythmia was not seen at follow-up. Cardiac phenotype in BTHS is variable; however, longer-term outcome in our cohort suggests good prognosis after the first 5 years of life. Most patients appeared to have recovered near normal cardiac function by conventional echocardiographic measures, but strain analysis showed abnormal myocardial deformation and rotational mechanics. PMID:26337810

  8. Comparison of the Effect of Two Human Milk Fortifiers on Clinical Outcomes in Premature Infants

    Directory of Open Access Journals (Sweden)

    Melissa Thoene

    2014-01-01

    Full Text Available The use of human milk fortifiers (HMF helps to meet the high nutritional requirements of the human milk-fed premature infant. Previously available powdered products have not met the protein requirements of the preterm infant population and many neonatologists add powder protein modulars to help meet protein needs. The use of powdered products is discouraged in neonatal intensive care units (NICU due to concern for invasive infection. The use of a commercially available acidified liquid product with higher protein content was implemented to address these two concerns. During the course of this implementation, poor growth and clinically significant acidosis of infants on Acidified Liquid HMF (ALHMF was observed. The purpose of this study was to quantify those observations by comparing infant outcomes between groups receiving the ALHMF vs. infants receiving powdered HMF (PHMF. A retrospective chart review compared outcomes of human milk-fed premature infants <2000 g receiving the ALHMF (n = 23 and the PHMF (n = 46. Infant growth, enteral feeding tolerance and provision, and incidence of necrotizing enterocolitis (NEC, metabolic acidosis, and diaper dermatitis were compared between the two groups. No infants were excluded from this study based on acuity. Use of ALHMF resulted in a higher incidence of metabolic acidosis (p = 0.002. Growth while on HMF as measured in both g/kg/day (10.59 vs. 15.37, p < 0.0001 and in g/day (23.66 vs. 31.27, p = 0.0001 was slower in the ALHMF group, on increased mean cal/kg/day (128.7 vs. 117.3, p = 0.13 with nearly twice as many infants on the ALHMF requiring increased fortification of enteral feedings beyond 24 cal/ounce to promote adequate growth (48% vs. 26%, p = 0.10. Although we were not powered to study NEC as a primary outcome, NEC was significantly increased in the ALHMF group. (13% vs. 0%, p = 0.03. Use of a LHMF in an unrestricted NICU population resulted in an increase in clinical complications within a high

  9. Patient-reported outcome measures in arthroplasty registries.

    Science.gov (United States)

    Rolfson, Ola; Eresian Chenok, Kate; Bohm, Eric; Lübbeke, Anne; Denissen, Geke; Dunn, Jennifer; Lyman, Stephen; Franklin, Patricia; Dunbar, Michael; Overgaard, Søren; Garellick, Göran; Dawson, Jill

    2016-07-01

    The International Society of Arthroplasty Registries (ISAR) Steering Committee established the Patient-Reported Outcome Measures (PROMs) Working Group to convene, evaluate, and advise on best practices in the selection, administration, and interpretation of PROMs and to support the adoption and use of PROMs for hip and knee arthroplasty in registries worldwide. The 2 main types of PROMs include generic (general health) PROMs, which provide a measure of general health for any health state, and specific PROMs, which focus on specific symptoms, diseases, organs, body regions, or body functions. The establishment of a PROM instrument requires the fulfillment of methodological standards and rigorous testing to ensure that it is valid, reliable, responsive, and acceptable to the intended population. A survey of the 41 ISAR member registries showed that 8 registries administered a PROMs program that covered all elective hip or knee arthroplasty patients and 6 registries collected PROMs for sample populations; 1 other registry had planned but had not started collection of PROMs. The most common generic instruments used were the EuroQol 5 dimension health outcome survey (EQ-5D) and the Short Form 12 health survey (SF-12) or the similar Veterans RAND 12-item health survey (VR-12). The most common specific PROMs were the Hip disability and Osteoarthritis Outcome Score (HOOS), the Knee injury and Osteoarthritis Outcome Score (KOOS), the Oxford Hip Score (OHS), the Oxford Knee Score (OKS), the Western Ontario and McMaster Universities Arthritis Index (WOMAC), and the University of California at Los Angeles Activity Score (UCLA). PMID:27168175

  10. Clinical Supervision in Treatment Transport: Effects on Adherence and Outcomes

    Science.gov (United States)

    Schoenwald, Sonja K.; Sheidow, Ashli J.; Chapman, Jason E.

    2009-01-01

    This nonexperimental study used mixed-effects regression models to examine relations among supervisor adherence to a clinical supervision protocol, therapist adherence, and changes in the behavior and functioning of youths with serious antisocial behavior treated with an empirically supported treatment (i.e., multisystemic therapy [MST]) 1 year…

  11. 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.

  12. Total Laparoscopic Hysterectomy Compared with Abdominal Hysterectomy; Clinical Outcomes

    Directory of Open Access Journals (Sweden)

    Cem Celik

    2013-10-01

    Full Text Available Aim: The purpose of this study was to confirm the positive intraoperative and postoperative outcomes of total laparoscopic hysterectomy (TLH and total abdominal hysterectomy (TAH. Material and Method: We presented surgical procedures performed at Namik Kemal University Faculty of Medicine, Department of Obstetrics and Gynecology between September 2010 and December 2012, 47 patients who underwent TLH and 30 patients who underwent TAH  were included in the present study. Results: Operating time in TLH group was significantly longer than in the TAH group (202.56±61.53 vs 138.06±40.52 min. There were no significant differences between the two groups regarding complications, conversion to laparotomy, intraoperative bleeding. We observed no differences in reoperation and transfusion rates between the two groups. Duration of hospital stay was statistically shorter in TLH group compared to the TAH group (3.93±0.70 vs 5.26±1.63 day. Discussion: Laparoscopic hysterectomy, compared to laparotomy regarding equal outcomes and lower perioperative morbidity, improvement of quality of life, shorter hospital stay and faster return to activity.

  13. 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.

  14. Very poor outcome schizophrenia: Clinical and neuroimaging aspects

    Science.gov (United States)

    Mitelman, Serge A.; Buchsbaum, Monte S.

    2009-01-01

    In spite of significant advances in treatment of patients with schizophrenia and continued efforts towards their deinstitutionalization, a considerable group of patients remain chronically hospitalized or otherwise dependent on others for basic necessities of life. It has been proposed that these patients belong to a distinct etiopathological subgroup, termed Kraepelinian, whose course of illness may be progressive and resistant to treatment. Indeed, longitudinal studies appear to show that elderly Kraepelinian patients follow a course of rapid cognitive and functional deterioration, commensurate with a dementing process, and that their poor functional status is closely correlated with the cognitive deterioration. Recent neuroimaging studies described a pattern of posteriorization of grey and white matter deficits with poor outcome in schizophrenia, and produced a constellation of findings implicating primary processing of visual and auditory information as central to the impaired functional status in this patient group. These studies are summarized in detail in this review and future directions for neuroimaging assessment of very poor outcome patients with schizophrenia are suggested. PMID:17671868

  15. Clinical features and outcomes of ANCA-associated renal vasculitis

    Directory of Open Access Journals (Sweden)

    Sidy Mohamed Seck

    2012-01-01

    Full Text Available To determine the patterns and outcomes of the pauci-immune vasculitis in the nephrology department at hospital La Conception in Marseille, we conducted a retrospective study including all patients with diagnosis of pauci-immune renal vasculitis between January 1, 2000 and December 31, 2007. Among 33 cases, 25 were diagnosed as Wegener granulomatosis (WG, seven as microscopic polyangitis (MPA and one as Churg-Strauss syndrome (SCS. The median age of the patients was 57.7 years and the sex-ratio (M/F was 1.6. The visceral mani-festations included kidneys (100% of patients, lungs (75%, ENT (52% of WG, and nervous system (57% of MPA. The mean serum creatinine at admission was 3.3 mg/dL. Renal biopsies revealed a pauci-immune crescentic gromerulonephritis in 96% of the cases. Two patients with WG received plasmapheresis and seven patients required emergency hemodialysis. Induction therapy comprised cyclophosphamide IV and corticosteroids, while maintenance therapy included azathioprine for the majority of patients. Eighty four percent of the patients experienced complete remission after induction therapy. During maintenance therapy relapses were more frequent among patients with MPA (28% compared to WG cases (12%. After 35 months of follow-up, eight patients ended on chronic hemodialysis, and five patients died. ANCA associated vasculitis are frequent in our patients. Long-term outcomes are relatively good despite a mortality rate of 15% and 25% of the patients entering dialysis after three years of follow-up.

  16. Arterial Stiffening and Clinical Outcomes in Dialysis Patients.

    Science.gov (United States)

    Kato, Akihiko

    2015-09-01

    Cardiovascular disease (CVD) is an important cause of morbidity and mortality in dialysis patients. Brachial-ankle pulse wave velocity (baPWV) is more efficient to handily assess arteriosclerosis than aortic PWV. The cardio-ankle vascular index (CAVI) is also a novel blood pressure-independent arterial stiffness parameter. In dialysis patients, both baPWV and CAVI are increased compared to general subjects. Several studies have demonstrated that increased baPWV is associated with carotid atherosclerosis and diastolic left ventricular dysfunction in hemodialysis (HD) patients. In addition, higher baPWV is related to all-cause and cardiovascular (CV) mortality. CAVI is similarly associated with CVD. However, baPWV is superior to CAVI as a predictor of CV outcomes in HD patients. Besides these outcomes, a close relationship exists between sarcopenia, abdominal visceral obesity and arterial stiffening. Reduction of thigh muscle mass is inversely correlated with baPWV and CAVI in males. Abdominal fatness is also associated with increased arterial stiffness in females. These observations provide further evidence of higher risk of CV events in HD patients with sarcopenic obesity. In addition, arterial stiffness is associated with cerebral small vessel disease and decreased cognitive function in the elderly. However, it is unknown whether arterial stiffness may be useful as an early indicator of cognitive decline in dialysis patients. Because dialysis patients are at risk of developing dementia, more studies are needed to elucidate the causal link between arterial stiffness and cognitive impairment. PMID:26587457

  17. Patient-Reported Outcomes in Metastatic Breast Cancer: A Review of Industry-Sponsored Clinical Trials

    Science.gov (United States)

    Krohe, Meaghan; Hao, Yanni; Lamoureux, Roger E.; Galipeau, Nina; Globe, Denise; Foley, Catherine; Mazar, Iyar; Solomon, Jeffrey; Shields, Alan L.

    2016-01-01

    INTRODUCTION Patient-reported outcome (PRO) measures serve to capture vital patient information not otherwise obtained by primary study endpoints. This paper examines how PROs are utilized as endpoints in industry-sponsored metastatic breast cancer clinical trials. METHODS A search was conducted in the clinicaltrials.gov web site for trials involving common treatments for metastatic breast cancer. Thirty-eight clinical trials were identified which included a PRO endpoint in the study, and data were extracted and summarized. RESULTS Overall, 17 unique PRO questionnaires and 14 concepts of measurement were identified as secondary or exploratory endpoints. The Functional Assessment of Cancer Therapy—Breast was the most frequently utilized questionnaire, commonly implemented to assess quality of life. The EORTC QLQ-C30 was also frequently used to measure quality of life or pain. CONCLUSION This review shares insights into the role of PROs in trials for metastatic breast cancer from which treatment developers and other stakeholders can enhance successful implementation of the patient voice into future trials. PMID:27441001

  18. Validation of the Focus on the Outcomes of Communication under Six outcome measure

    OpenAIRE

    Thomas-Stonell, Nancy; Oddson, Bruce; Robertson, Bernadette; Rosenbaum, Peter

    2013-01-01

    Aim The aim of this study was to establish the construct validity of the Focus on the Outcomes of Communication Under Six (FOCUS©),a tool designed to measure changes in communication skills in preschool children. Method Participating families' children (n=97; 68 males, 29 females; mean age 2y 8mo; SD 1.04y, range 10mo–4y 11mo) were recruited through eight Canadian organizations. The children were on a waiting list for speech and language intervention. Parents completed the Ages and Stages Que...

  19. An Approach to Acquiring, Normalizing, and Managing EHR Data From a Clinical Data Repository for Studying Pressure Ulcer Outcomes.

    Science.gov (United States)

    Padula, William V; Blackshaw, Leon; Brindle, C Tod; Volchenboum, Samuel L

    2016-01-01

    Changes in the methods that individual facilities follow to collect and store data related to hospital-acquired pressure ulcer (HAPU) occurrences are essential for improving patient outcomes and advancing our understanding the science behind this clinically relevant issue. Using an established electronic health record system at a large, urban, tertiary-care academic medical center, we investigated the process required for taking raw data of HAPU outcomes and submitting these data to a normalization process. We extracted data from 1.5 million patient shifts and filtered observations to those with a Braden score and linked tables in the electronic health record, including (1) Braden scale scores, (2) laboratory outcomes data, (3) surgical time, (4) provider orders, (5) medications, and (6) discharge diagnoses. Braden scores are important measures specific to HAPUs since these scores clarify the daily risk of a hospitalized patient for developing a pressure ulcer. The other more common measures that may be associated with HAPU outcomes are important to organize in a single data frame with Braden scores according to each patient. Primary keys were assigned to each table, and the data were processed through 3 normalization steps and 1 denormalization step. These processes created 8 tables that can be stored efficiently in a clinical database of HAPU outcomes. As hospitals focus on organizing data for review of HAPUs and other types of hospital-acquired conditions, the normalization process we describe in this article offers directions for collaboration between providers and informatics teams using a common language and structure. PMID:26727681

  20. 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

  1. 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...

  2. 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

  3. Pythium insidiosum colitis in a dog: treatment and clinical outcome

    OpenAIRE

    Mahyumi Fujimori; Erika Rondon Lopes; Samara Rosolem Lima; Daphine Ariadne Jesus de Paula; Arleana do Bom Parto Ferreira de Almeida; Edson Moleta Colodel; Caroline Argenta Pescador; Pedro Eduardo Brandini Néspoli; Luciano Nakazato; Valéria Dutra; Roberto Lopes de Souza; Valéria Régia Franco Sousa

    2016-01-01

    ABSTRACT: The aim of this report is to describe the clinical, pathological and imaging findings and treatment of colitis caused by Pythium insidiosum in a canine presenting haematochezia and progressive weight loss. Through imaging, a thickening of the transverse and descending colon was observed. Histopathological analysis of the large intestine fragment revealed the presence of hyphae, confirmed by immunohistochemistry and PCR as P. insidiosum. Antifungal treatment with itraconazole impleme...

  4. Pythium insidiosum colitis in a dog: treatment and clinical outcome

    Directory of Open Access Journals (Sweden)

    Mahyumi Fujimori

    2016-03-01

    Full Text Available ABSTRACT: The aim of this report is to describe the clinical, pathological and imaging findings and treatment of colitis caused by Pythium insidiosum in a canine presenting haematochezia and progressive weight loss. Through imaging, a thickening of the transverse and descending colon was observed. Histopathological analysis of the large intestine fragment revealed the presence of hyphae, confirmed by immunohistochemistry and PCR as P. insidiosum. Antifungal treatment with itraconazole implemented after partial surgical resection, resulted in control of the disease.

  5. Clinical Supervision in Treatment Transport: Effects on Adherence and Outcomes

    OpenAIRE

    Schoenwald, Sonja K.; Sheidow, Ashli J.; Chapman, Jason E.

    2009-01-01

    This non-experimental study used Mixed-Effects Regression Models (MRMs) to examine relations among supervisor adherence to a clinical supervision protocol, therapist adherence, and changes in the behavior and functioning of youth with serious antisocial behavior treated with an empirically supported treatment (i.e., Multisystemic Therapy), one-year post treatment. Participants were 1979 youth and families treated by 429 clinicians across 45 provider organizations in North America. Four dimens...

  6. Clinical and functional outcomes of the saddle prosthesis

    OpenAIRE

    Donati, D.; D’Apote, G.; M. Boschi; Cevolani, L.; M.G. Benedetti

    2012-01-01

    Background The implantation of a saddle prosthesis after resection of a pelvic tumor has been proposed as a simple method of reconstruction that provides good stability and reduces the surgical time, thus limits the onset of intraoperative complications. There are no studies in the literature of patients evaluated using gait analysis after being implanted with a saddle prosthesis. The present study is a retrospective case review aimed at illustrating long-term clinical and functional findings...

  7. Measurement of social capital among clinical research trainees.

    Science.gov (United States)

    Primack, Brian A; Colditz, Jason B; Cohen, Elan; Switzer, Galen E; Robinson, Georgeanna F W B; Seltzer, Deborah L; Rubio, Doris M; Kapoor, Wishwa N

    2014-02-01

    While physical and human capital are established as important predictors of success among early-career clinical investigators, less is known about the role of social capital. The authors aimed to develop a brief scale to assess social capital in this population and test its reliability and validity. A three-item assessment was developed based on a conceptual framework and measures of social capital from other fields and was administered to 414 clinical research trainees at the University of Pittsburgh in 2007-2012. The measure exhibited good internal consistency reliability (α = 0.71) and a normal distribution. On a 10-point scale, mean social capital was 6.4 (SD = 1.7). Social capital was significantly associated with 7 of the 9 expected constructs: sex, age, confidence in research skills, work-related motivation, burnout, and social support. Exploratory multivariable regression analysis demonstrated that social capital was most strongly associated with higher research confidence (β = 0.35, p extrinsic motivation (β = 0.50, p = 0.003), and lower burnout (ptrend = 0.02). This three-item scale measures social capital in this population with adequate internal consistency reliability, face validity, and construct validity. This brief assessment provides a tool that may be valuable to benchmark social capital of clinical research trainees and to better contextualize programmatic and trainee outcomes. PMID:24118964

  8. Measuring pacemaker dose: A clinical perspective

    Energy Technology Data Exchange (ETDEWEB)

    Studenski, Matthew T., E-mail: matthew.studenski@jeffersonhospital.org [Department of Radiation Oncology at the Jefferson Medical College and Kimmel Cancer Center, Thomas Jefferson University, Philadelphia, PA (United States); Xiao Ying; Harrison, Amy S. [Department of Radiation Oncology at the Jefferson Medical College and Kimmel Cancer Center, Thomas Jefferson University, Philadelphia, PA (United States)

    2012-07-01

    Recently in our clinic, we have seen an increased number of patients presenting with pacemakers and defibrillators. Precautions are taken to develop a treatment plan that minimizes the dose to the pacemaker because of the adverse effects of radiation on the electronics. Here we analyze different dosimeters to determine which is the most accurate in measuring pacemaker or defibrillator dose while at the same time not requiring a significant investment in time to maintain an efficient workflow in the clinic. The dosimeters analyzed here were ion chambers, diodes, metal-oxide-semiconductor field effect transistor (MOSFETs), and optically stimulated luminescence (OSL) dosimeters. A simple phantom was used to quantify the angular and energy dependence of each dosimeter. Next, 8 patients plans were delivered to a Rando phantom with all the dosimeters located where the pacemaker would be, and the measurements were compared with the predicted dose. A cone beam computed tomography (CBCT) image was obtained to determine the dosimeter response in the kilovoltage energy range. In terms of the angular and energy dependence of the dosimeters, the ion chamber and diode were the most stable. For the clinical cases, all the dosimeters match relatively well with the predicted dose, although the ideal dosimeter to use is case dependent. The dosimeters, especially the MOSFETS, tend to be less accurate for the plans, with many lateral beams. Because of their efficiency, we recommend using a MOSFET or a diode to measure the dose. If a discrepancy is observed between the measured and expected dose (especially when the pacemaker to field edge is <10 cm), we recommend analyzing the treatment plan to see whether there are many lateral beams. Follow-up with another dosimeter rather than repeating multiple times with the same type of dosimeter. All dosimeters should be placed after the CBCT has been acquired.

  9. Measuring pacemaker dose: A clinical perspective

    International Nuclear Information System (INIS)

    Recently in our clinic, we have seen an increased number of patients presenting with pacemakers and defibrillators. Precautions are taken to develop a treatment plan that minimizes the dose to the pacemaker because of the adverse effects of radiation on the electronics. Here we analyze different dosimeters to determine which is the most accurate in measuring pacemaker or defibrillator dose while at the same time not requiring a significant investment in time to maintain an efficient workflow in the clinic. The dosimeters analyzed here were ion chambers, diodes, metal-oxide-semiconductor field effect transistor (MOSFETs), and optically stimulated luminescence (OSL) dosimeters. A simple phantom was used to quantify the angular and energy dependence of each dosimeter. Next, 8 patients plans were delivered to a Rando phantom with all the dosimeters located where the pacemaker would be, and the measurements were compared with the predicted dose. A cone beam computed tomography (CBCT) image was obtained to determine the dosimeter response in the kilovoltage energy range. In terms of the angular and energy dependence of the dosimeters, the ion chamber and diode were the most stable. For the clinical cases, all the dosimeters match relatively well with the predicted dose, although the ideal dosimeter to use is case dependent. The dosimeters, especially the MOSFETS, tend to be less accurate for the plans, with many lateral beams. Because of their efficiency, we recommend using a MOSFET or a diode to measure the dose. If a discrepancy is observed between the measured and expected dose (especially when the pacemaker to field edge is <10 cm), we recommend analyzing the treatment plan to see whether there are many lateral beams. Follow-up with another dosimeter rather than repeating multiple times with the same type of dosimeter. All dosimeters should be placed after the CBCT has been acquired.

  10. Effect of prehospital ultrasound on clinical outcomes of non-trauma patients

    DEFF Research Database (Denmark)

    Rudolph, Søren Steemann; Sørensen, Martin Kryspin; Svane, Christian;

    2014-01-01

    BACKGROUND: Advances in technology have made prehospital ultrasound (US) examination available. Whether US in the prehospital setting can lead to improvement in clinical outcomes is yet unclear. OBJECTIVE: The aim of this systematic review was to assess whether prehospital US improves clinical...... studies were of large heterogeneity and all showed a high risk of bias. We were thus unable to assess the effect of prehospital US on clinical outcomes. However, consistent reports suggested that US may improve patient management with respect to diagnosis, treatment, and hospital referral....

  11. 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

  12. Learning disability and epilepsy. 1, towards common outcome measures.

    Science.gov (United States)

    Kerr, M P; Espie, C A

    1997-10-01

    A major component of the population of people who have epilepsy are people with a learning disability. As a group, such individuals often have complex epilepsy which is refractory to treatment. Current available measures to assess the outcomes of therapeutic interventions in epilepsy are based on seizure frequency, seizure severity and quality-of-life measures, but have not been validated in people with a learning disability. Thus, we do not know if such measures of outcome serve the needs of this group. This review examines how able we are to assess the efficacy of our interventions to control epilepsy in people with learning disability. It is suggested that a standard data set is necessary as the basis of the assessment of any therapeutic intervention. Central components of this data set would encompass a definition of important characteristics of an individual, a description of their epilepsy and an assessment of the impact of their condition on both their own and their carer's health. The approach to obtaining this information should employ a methodology which can allow for environmental influences. PMID:9663796

  13. Are the outcomes of clinical pathways evidence-based? A critical appraisal of clinical pathway evaluation research

    OpenAIRE

    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 (SM). We included randomized controlled or quasi-experimental studies evaluating the efficacy of clinical pathway application. Assessment of the methodological quality of the studies included rand...

  14. Assessing clinical and functional outcomes in a gene-environment interaction study in first episode of psychosis (PEPs).

    Science.gov (United States)

    Bernardo, Miquel; Bioque, Miquel; Parellada, Mara; Saiz Ruiz, Jerónimo; Cuesta, Manuel J; Llerena, Adrián; Sanjuán, Julio; Castro-Fornieles, Josefina; Arango, Celso; Cabrera, Bibiana

    2013-01-01

    The PEPs study is a multicenter, naturalistic, prospective, longitudinal study designed to evaluate clinical, neuropsychological, neuroimaging, biochemical, environmental and pharmacogenetic variables in a sample of nearly 350 first episode of psychosis patients and 250 healthy controls. The PEPs project was conducted in Spain from January 2009 to December 2011. This article describes the rationale for the measurement approach adopted, providing an overview of the selected clinical and functional measures. The main objectives are: a) the thorough clinical and neurocognitive characterization of a sample of first episodes of psychosis, and b) the study of the interactions between the genetic and environmental variables selected to predict clinical and brain structural outcomes, and to determine the relationship of genetic polymorphisms involved in the pharmacokinetics and pharmacodynamics, and the responses and adverse effects of treatment. PMID:23206389

  15. Health economics research into supporting carers of people with dementia: a systematic review of outcome measures.

    Science.gov (United States)

    Jones, Carys; Edwards, Rhiannon Tudor; Hounsome, Barry

    2012-01-01

    Advisory bodies, such as the National Institute for Health and Clinical Excellence (NICE) in the UK, advocate using preference based instruments to measure the quality of life (QoL) component of the quality-adjusted life year (QALY). Cost per QALY is used to determine cost-effectiveness, and hence funding, of interventions. QALYs allow policy makers to compare the effects of different interventions across different patient groups. Generic measures may not be sensitive enough to fully capture the QoL effects for certain populations, such as carers, so there is a need to consider additional outcome measures, which are preference based where possible to enable cost-effectiveness analysis to be undertaken. This paper reviews outcome measures commonly used in health services research and health economics research involving carers of people with dementia. An electronic database search was conducted in PubMed, Medline, the Cumulative Index to Nursing and Allied Health Literature (CINAHL), PsycINFO, the National Health Service Economic Evaluation Database (NHS EED), Database of Abstracts of Reviews of Effects (DARE) and Health Technology Assessment database. Studies were eligible for inclusion if they included an outcome measure for carers of people with dementia. 2262 articles were identified. 455 articles describing 361 studies remained after exclusion criteria were applied. 228 outcome measures were extracted from the studies. Measures were categorised into 44 burden measures, 43 mastery measures, 61 mood measures, 32 QoL measures, 27 social support and relationships measures and 21 staff competency and morale measures. The choice of instrument has implications on funding decisions; therefore, researchers need to choose appropriate instruments for the population being measured and the type of intervention undertaken. If an instrument is not sensitive enough to detect changes in certain populations, the effect of an intervention may be underestimated, and hence

  16. Measurement properties of patient-reported outcome measures (PROMs) in adults with obstructive sleep apnea (OSA): A systematic review.

    Science.gov (United States)

    Abma, Inger L; van der Wees, Philip J; Veer, Vik; Westert, Gert P; Rovers, Maroeska

    2016-08-01

    This systematic review summarizes the evidence regarding the quality of patient-reported outcome measures (PROMs) validated in patients with obstructive sleep apnea (OSA). We performed a systematic literature search of all PROMs validated in patients with OSA, and found 22 measures meeting our inclusion criteria. The quality of the studies was assessed using the consensus-based standards for the selection of health status measurement instruments (COSMIN) checklist. The results showed that most of the measurement properties of the PROMs were not, or not adequately, assessed. For many identified PROMs there was no involvement of patients with OSA during their development or before the PROM was tested in patients with OSA. Positive exceptions and the best current candidates for assessing health status in patients with OSA are the sleep apnea quality of life index (SAQLI), Maugeri obstructive sleep apnea syndrome (MOSAS) questionnaire, Quebec sleep questionnaire (QSQ) and the obstructive sleep apnea patient-oriented severity index (OSAPOSI). Even though there is not enough evidence to fully judge the quality of these PROMs as outcome measure, when interpreted with caution, they have the potential to add value to clinical research and clinical practice in evaluating aspects of health status that are important to patients. PMID:26433776

  17. Prostate Cancer: Prognostic factors, markers of outcome and design of clinical trials

    OpenAIRE

    Collette, Lau

    2006-01-01

    textabstractPhase III clinical trials to assess the clinical benefit of new treatment options often require large patient numbers and long follow-up, in particular in diseases with a long natural history, such as prostate cancer. In this thesis, we argue that in order to improve the efficiency of phase III prostate cancer clinical trials, a thorough understanding of prognostic factors of outcome is needed, as well as an exploration of potential predictive factors that might affect treatment b...

  18. Clinical outcomes and prediction of survival following percutaneous biliary drainage for malignant obstructive jaundice

    OpenAIRE

    Zhang, Guang Yuan; LI, WEN TAO; PENG, WEI JUN; LI, GUO DONG; HE, XIN HONG; XU, LI CHAO

    2014-01-01

    The present study aimed to investigate the clinical outcomes of percutaneous transhepatic biliary drainage in patients with obstructive jaundice and identify potential predictors of patient survival. Clinical data from 102 patients (66 males and 36 females; median age, 63.50 years; range, 29–84 years) with a mean (± standard deviation) pre-drainage serum bilirubin level of 285.4 (±136.7 μmol/l), were retrospectively studied. Technical and clinical success, complications and survival time were...

  19. 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. PMID:26369708

  20. Current measures of metabolic heterogeneity within cervical cancer do not predict disease outcome

    Directory of Open Access Journals (Sweden)

    Brooks Frank J

    2011-06-01

    Full Text Available Abstract Background A previous study evaluated the intra-tumoral heterogeneity observed in the uptake of F-18 fluorodeoxyglucose (FDG in pre-treatment positron emission tomography (PET scans of cancers of the uterine cervix as an indicator of disease outcome. This was done via a novel statistic which ostensibly measured the spatial variations in intra-tumoral metabolic activity. In this work, we argue that statistic is intrinsically non-spatial, and that the apparent delineation between unsuccessfully- and successfully-treated patient groups via that statistic is spurious. Methods We first offer a straightforward mathematical demonstration of our argument. Next, we recapitulate an assiduous re-analysis of the originally published data which was derived from FDG-PET imagery. Finally, we present the results of a principal component analysis of FDG-PET images similar to those previously analyzed. Results We find that the previously published measure of intra-tumoral heterogeneity is intrinsically non-spatial, and actually is only a surrogate for tumor volume. We also find that an optimized linear combination of more canonical heterogeneity quantifiers does not predict disease outcome. Conclusions Current measures of intra-tumoral metabolic activity are not predictive of disease outcome as has been claimed previously. The implications of this finding are: clinical categorization of patients based upon these statistics is invalid; more sophisticated, and perhaps innately-geometric, quantifications of metabolic activity are required for predicting disease outcome.

  1. Estimating recruitment rates for routine use of patient reported outcome measures and the impact on provider comparisons.

    OpenAIRE

    Hutchings, A; Neuburger, J; van der Meulen, J; Black, N.

    2014-01-01

    BACKGROUND The routine use of patient reported outcome measures (PROMs) aims to compare providers as regards the clinical need of their patients and their outcome. Simple methods of estimating recruitment rates based on aggregated data may be inaccurate. Our objectives were to: use patient-level linked data to evaluate these estimates; produce revised estimates of national and providers' recruitment rates; and explore whether or not recruitment bias exists. METHODS Case study based on pa...

  2. Clinical and radiographic findings, treatment, and outcome in cattle with osteochondrosis: 29 cases (1986-1996)

    International Nuclear Information System (INIS)

    Objective-To summarize the radiographic and clinical findings, treatment, and outcome in cattle with osteochondrosis diagnosed radiographically. Design-Retrospective case series. Sample Population-29 cattle with radiographic evidence of osteochondrosis. Procedures-Medical records were reviewed, and owners or referring veterinarians were contacted for outcome assessment. Data were analyzed for potential interactions between osteochondrosis classification (osteochondritis dessicans vs subchondral cyst-like lesions), clinical and radiographic findings, treatment, and outcome, using Fisher's exact test and descriptive statistics. Results-Osteochondrosis was associated with young, male, purebred cattle, clinical evidence of lameness, and radiographic evidence of concurrent degenerative joint disease. Osteochondritis dissecans and subchondral cyst-like lesions had similar clinical findings and outcomes but varied significantly in their radiographic distribution among joints. Osteochondrosis often manifests clinically as a unilateral condition, but bilateral lesions were often found (88%) when limbs were radiographically examined. Cattle managed conservatively tended to be culled (within 6 months of diagnosis because of lameness) more often than those managed surgically, despite the lack of treatment bias. ClinicalImplications-Osteochondrosis in cattle is often associated with lameness or degenerative joint disease. Conservative management does not result in a favorable clinical prognosis for long-term, lameness-free survival, and more studies need to be completed to evaluate the efficacy of surgical treatment of osteochondrosis in cattle

  3. Outcome assessment of a triangular clinic as a harm reduction intervention in Rajaee-Shahr Prison, Iran

    OpenAIRE

    Asl, Rahim Taghizadeh; Eshrati, Babak; Dell Colleen Anne; Taylor, Kelli; Afshar, Parviz; Kamali, Mohammad; Mirzazadeh, Ali

    2013-01-01

    Background Transmission of the human immunodeficiency virus (HIV) among incarcerated injection drug users (IDU) is a health epidemic in the Islamic Republic of Iran. Triangular clinics (TCs) were established in prisons as a harm reduction measure to decrease the risk of HIV transmission and other blood-borne infections. The objective of this study was to assess the immediate outcomes of one TC among male IDUs in Iran’s Rajaee-Shahr prison. Methods This study was conducted in two stages betwee...

  4. Evaluation of patient perceptions and outcomes related to anticoagulation point-of-care testing in ambulatory care clinics

    OpenAIRE

    Fermo JD; Whitley HP; Thompson AM; Ragucci KR

    2009-01-01

    Until recently, Prothrombin Time/International Normalized Ratio (PT/INR) measurements have typically been used to monitor patients on warfarin through institutional laboratories via venous puncture. The Point-of-Care Testing (POCT) device has revolutionized the patient care process by allowing for laboratory testing outside of the central laboratory. Objective: To analyze humanistic and clinical outcomes in patients currently treated with warfarin and monitored through a pharmacist-managed an...

  5. Post-Exercise Heart Rate Recovery Independently Predicts Clinical Outcome in Patients with Acute Decompensated Heart Failure

    OpenAIRE

    Youn, Jong-Chan; Lee, Hye Sun; Choi, Suk-Won; Han, Seong-Woo; Ryu, Kyu-Hyung; Shin, Eui-Cheol; Kang, Seok-Min

    2016-01-01

    Background Post-exercise heart rate recovery (HRR) is an index of parasympathetic function associated with clinical outcome in patients with chronic heart failure. However, its relationship with the pro-inflammatory response and prognostic value in consecutive patients with acute decompensated heart failure (ADHF) has not been investigated. Methods We measured HRR and pro-inflammatory markers in 107 prospectively and consecutively enrolled, recovered ADHF patients (71 male, 59 ± 15 years, mea...

  6. A comparative study of clinical outcomes of post placental insertion versus interval insertion of Copper T 380A intrauterine device

    OpenAIRE

    Suchi Gupta; Shubha Sagar Trivedi; Ratna Biswas

    2015-01-01

    Background: The objective of this study was to study the safety and efficacy of PPIUCD insertion and to compare it with interval insertion. Methods: A prospective study was conducted enrolling 100 women as study group (PPIUCD) and 100 as control group (interval CuT insertion). All women were followed up for 6 months and clinical outcomes were measured in terms of safety, efficacy, effect on menstrual cycles and continuation rates. Chi square test was used to detect differences in the rate...

  7. 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.

  8. Improving periodontal outcomes: merging clinical and behavioral science.

    Science.gov (United States)

    Wilder, Rebecca S; Bray, Kimberly S

    2016-06-01

    New data indicate that periodontal diseases are much more prevalent than previously thought, which means that there are large numbers of patients who will need to be diagnosed and treated for periodontal disease in a general dental practice. Oral hygiene procedures performed by patients between office visits are important for gingival health. No particular type of toothbrush has consistently been shown to have superior plaque-removal ability over another. Although studies on powered brushes have shown evidence for efficacy of biofilm removal and increased patient compliance, they are of short duration, making evaluation of long-term effects difficult to achieve. Interdental cleaning with dental floss can be effective but it is technique-sensitive. Interdental brushes have been shown to be superior to floss in plaque index scores, but not in gingival inflammation reduction. A systematic review of oral irrigation reported a beneficial adjunctive effect on bleeding and gingival indices and pocket depth. Antimicrobials in mouthrinses and toothpastes have shown significant reductions in plaque and gingivitis when used correctly. Even though it is considered essential for patients to utilize biofilm-removal techniques on a frequent basis, studies on adherence show that approximately 30-60% of health information is forgotten within 1 h, and 50% of health recommendations are not followed. Incorporating psychosocial aspects of behavioral change, including well-established counseling strategies, such as motivational interviewing, may elicit improved patient outcomes. PMID:27045431

  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. An International Standard Set of Patient-Centered Outcome Measures After Stroke

    Science.gov (United States)

    Salinas, Joel; Sprinkhuizen, Sara M.; Ackerson, Teri; Bernhardt, Julie; Davie, Charlie; George, Mary G.; Gething, Stephanie; Kelly, Adam G.; Lindsay, Patrice; Liu, Liping; Martins, Sheila C.O.; Morgan, Louise; Norrving, Bo; Ribbers, Gerard M.; Silver, Frank L.; Smith, Eric E.; Williams, Linda S.

    2016-01-01

    Background and Purpose— Value-based health care aims to bring together patients and health systems to maximize the ratio of quality over cost. To enable assessment of healthcare value in stroke management, an international standard set of patient-centered stroke outcome measures was defined for use in a variety of healthcare settings. Methods— A modified Delphi process was implemented with an international expert panel representing patients, advocates, and clinical specialists in stroke outcomes, stroke registers, global health, epidemiology, and rehabilitation to reach consensus on the preferred outcome measures, included populations, and baseline risk adjustment variables. Results— Patients presenting to a hospital with ischemic stroke or intracerebral hemorrhage were selected as the target population for these recommendations, with the inclusion of transient ischemic attacks optional. Outcome categories recommended for assessment were survival and disease control, acute complications, and patient-reported outcomes. Patient-reported outcomes proposed for assessment at 90 days were pain, mood, feeding, selfcare, mobility, communication, cognitive functioning, social participation, ability to return to usual activities, and health-related quality of life, with mobility, feeding, selfcare, and communication also collected at discharge. One instrument was able to collect most patient-reported subdomains (9/16, 56%). Minimum data collection for risk adjustment included patient demographics, premorbid functioning, stroke type and severity, vascular and systemic risk factors, and specific treatment/care-related factors. Conclusions— A consensus stroke measure Standard Set was developed as a simple, pragmatic method to increase the value of stroke care. The set should be validated in practice when used for monitoring and comparisons across different care settings. PMID:26604251

  11. Adjustment as process and outcome: Measuring adjustment to HIV in Uganda.

    Science.gov (United States)

    Martin, Faith; Russell, Steve; Seeley, Janet

    2016-05-01

    'Adjustment' in health refers to both processes and outcomes. Its measurement and conceptualisation in African cultures is limited. In total, 263 people living with HIV and receiving anti-retroviral therapy in clinics in Uganda completed a translated Mental Adjustment to HIV Scale, depression items from the Hopkins checklist and demographic questions. Factor analysis revealed four Mental Adjustment to HIV factors of active coping, cognitive-social adjustment, hopelessness and denial/avoidance. Correlations with depression supported the Mental Adjustment to HIV's validity and the importance of active adjustment, while the role of cognitive adjustment was unclear. Factors were process or outcome focussed, suggesting a need for theory-based measures in general. PMID:25030794

  12. Adjunctive naturopathic care for type 2 diabetes: patient-reported and clinical outcomes after one year

    Directory of Open Access Journals (Sweden)

    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

  13. Rhino-Orbito-Cerebral Mucormycosis. A Retrospective Analysis of Clinical Features and Treatment Outcomes

    Directory of Open Access Journals (Sweden)

    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

  14. 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.

  15. Clinical outcomes and efficacy of transforaminal lumbar endoscopic discectomy

    Directory of Open Access Journals (Sweden)

    Cezmi Çagri Türk

    2015-01-01

    Full Text Available Background: Transforaminal lumbar endoscopic discectomy (TLED is a minimally invasive procedure for removing lumbar disc herniations. This technique was initially reserved for herniations in the foraminal or extraforaminal region. This study concentrated on our experience regarding the outcomes and efficacy of TLED. Materials and Methods: A total of 105 patients were included in the study. The patients were retrospectively evaluated for demographic features, lesion levels, numbers of affected levels, visual analog scores (VASs, Oswestry disability questionnaire scale scores and MacNab pain relief scores. Results: A total of 48 female and 57 male patients aged between 25 and 64 years (mean: 41.8 years underwent TLED procedures. The majority (83% of the cases were operated on at the levels of L4-5 and L5-S1. Five patients had herniations at two levels. There were significant decreases between the preoperative VAS scores collected postoperatively at 6 months (2.3 and those collected after 1-year (2.5. Two patients were referred for microdiscectomy after TLED due to unsatisfactory pain relief on the 1 st postoperative day. The overall success rate with respect to pain relief was 90.4% (95/105. Seven patients with previous histories of open discectomy at the same level reported fair pain relief after TLED. Conclusions: Transforaminal lumbar endoscopic discectomy is a safe and effective alternative to microdiscectomy that is associated with minor tissue trauma. Herniations that involved single levels and foraminal/extraforaminal localizations were associated with better responses to TLED.

  16. Stem Cell Transplantation As A Dynamical System: Are Clinical Outcomes Deterministic?

    Directory of Open Access Journals (Sweden)

    Amir A Toor

    2014-12-01

    Full Text Available Outcomes in stem cell transplantation (SCT are modeled using probability theory. However the clinical course following SCT appears to demonstrate many characteristics of dynamical systems, especially when outcomes are considered in the context of immune reconstitution. Dynamical systems tend to evolve over time according to mathematically determined rules. Characteristically, the future states of the system are predicated on the states preceding them, and there is sensitivity to initial conditions. In SCT, the interaction between donor T cells and the recipient may be considered as such a system in which, graft source, conditioning and early immunosuppression profoundly influence immune reconstitution over time. This eventually determines clinical outcomes, either the emergence of tolerance or the development of graft versus host disease. In this paper parallels between SCT and dynamical systems are explored and a conceptual framework for developing mathematical models to understand disparate transplant outcomes is proposed.

  17. Outcomes of laparoscopic adrenalectomy. Clinical experience with 68 patients.

    Science.gov (United States)

    Pugliese, Raffaele; Boniardi, Marco; Sansonna, Fabio; Maggioni, Dario; De Carli, Stefano; Costanzi, Andrea; Scandroglio, Ildo; Ferrari, Giovanni Carlo; Di Lernia, Stefano; Magistro, Carmelo; Loli, Paola; Grossrubatscher, Erika

    2008-07-01

    The aim of this study was to analyze feasibility and outcomes of laparoscopic adrenalectomy (LA). Pathology, size and bilateral site of lesions were considered. Between December 1998 and May 2007 in our institution a total of 68 patients of mean age of 53 years underwent unilateral (n=57) or bilateral (n=11) LA. Adrenal masses averaged 5.4cm in size (range 1.2-13cm) and 56.7g in weight (range 10-265) including 71 benign and 8 malignant lesions. A total of 79 adrenal glands were resected, 44 right sided and 35 left sided. Removal was complete in 77 cases and partial (sparing adrenalectomy) in 1 patient affected by bilateral pheochomocytoma. Three left adrenalectomies for pheochromocytoma were robot-assisted. The transperitoneal lateral approach was preferred and the posterior retroperitoneal approach was adopted in 5 patients. The mean duration of surgery for each LA was 138+/-90min and 3.8 trocar were used on average (range 3-6). Conversion was needed in 3 cases owing to difficult dissection of large masses. Estimated mean blood loss for each LA was 95+/-30ml and it was greater for bilateral LA. Mortality was nil and morbidity was 5.8%. The average length of hospital stay (LOS) in surgical unit was 4+/-2.4 days (range 2-8). Patients affected by hormone secreting or bilateral lesions, by unilateral or bilateral pheochromocytoma and by bilateral Cushing's disease were transferred to the endocrinological ward so that their overall hospital stay was prolonged to 9+/-2.8 days on average (range 7-17). Mean duration of follow-up of patients was 38 months (range 2-100) and demonstrated acceptable endocrine results. Three primary cortical carcinomas were discovered as chance findings on histologic examination. While long-term results after LA for cortical carcinomas were poor and LA is not recommended in such cases, long-term results after LA for adrenal metastases were encouraging. PMID:17949973

  18. 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.

  19. Perfusion CT in acute stroke: prediction of vessel recanalization and clinical outcome in intravenous thrombolytic therapy

    International Nuclear Information System (INIS)

    This study evaluated perfusion computed tomography (PCT) for the prediction of vessel recanalization and clinical outcome in patients undergoing intravenous thrombolysis. Thirty-nine patients with acute ischemic stroke of the middle cerebral artery territory underwent intravenous thrombolysis within 3 h of symptom onset. They all had non-enhanced CT (NECT), PCT, and CT angiography (CTA) before treatment. The Alberta Stroke Program Early Computed Tomography (ASPECT) score was applied to NECT and PCT maps to assess the extent of ischemia. CTA was assessed for the site of vessel occlusion. The National Institute of Health Stroke Scale (NIHSS) score was used for initial clinical assessment. Three-month clinical outcome was assessed using the modified Rankin scale. Vessel recanalization was determined by follow-up ultrasound. Of the PCT maps, a cerebral blood volume (CBV) ASPECT score of >6 versus ≤6 was the best predictor for clinical outcome (odds ratio, 31.43; 95% confidence interval, 3.41-289.58; P < 0.002), and was superior to NIHSS, NECT and CTA. No significant differences in ASPECT scores were found for the prediction of vessel recanalization. ASPECT score applied to PCT maps in acute stroke patients predicts the clinical outcome of intravenous thrombolysis and is superior to both early NECT and clinical parameters. (orig.)

  20. Development and Validation of the Keele Musculoskeletal Patient Reported Outcome Measure (MSK-PROM.

    Directory of Open Access Journals (Sweden)

    Jonathan C Hill

    Full Text Available To develop and validate a patient report outcome measure (PROM for clinical practice that can monitor health status of patients with a range of musculoskeletal (MSK disorders.Constructs for inclusion in the MSK-PROM were identified from a consensus process involving patients with musculoskeletal conditions, clinicians, purchasers of healthcare services, and primary care researchers. Psychometric properties of the brief tool, including face and construct validity, repeatability and responsiveness were assessed in a sample of patients with musculoskeletal pain consulting physiotherapy services in the United Kingdom (n=425.The consensus process identified 10 prioritised domains for monitoring musculoskeletal health status: pain intensity, quality of life, physical capacity, interference with social/leisure activities, emotional well-being, severity of most difficult thing, activities and roles, understanding independence, and overall impact. As the EuroQol (EQ-5D-5L is a widely adopted PROMs tool and covers the first four domains listed, to reduce patient burden to a minimum the MSK-PROM was designed to capture the remaining six prioritised domains which are not measured by the EQ-5D-5L. The tool demonstrated excellent reliability, construct validity, responsiveness and acceptability to patients and clinicians for use in clinical practice.We have validated a brief patient reported outcome measure (MSK-PROM for use in clinical practice to measure musculoskeletal health status and monitor outcomes over time using domains that are meaningful to patients and sensitive to change. Further work will establish whether the MSK-PROM is useful in other musculoskeletal healthcare settings.

  1. Prevalence of Sarcopenia and Associated Outcomes in the Clinical Setting.

    Science.gov (United States)

    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. PMID:26703961

  2. Propionic acidemia: clinical course and outcome in 55 pediatric and adolescent patients

    OpenAIRE

    Grünert Sarah C; Müllerleile Stephanie; De Silva Linda; Barth Michael; Walter Melanie; Walter Kerstin; Meissner Thomas; Lindner Martin; Ensenauer Regina; Santer René; Bodamer Olaf A; Baumgartner Matthias R; Brunner-Krainz Michaela; Karall Daniela; Haase Claudia

    2013-01-01

    Abstract Background Propionic acidemia is an inherited disorder caused by deficiency of propionyl-CoA carboxylase. Although it is one of the most frequent organic acidurias, information on the outcome of affected individuals is still limited. Study design/methods Clinical and outcome data of 55 patients with propionic acidemia from 16 European metabolic centers were evaluated retrospectively. 35 patients were diagnosed by selective metabolic screening while 20 patients were identified by newb...

  3. Factors associated with the clinical outcomes of paediatric out-of-hospital cardiac arrest in Japan

    OpenAIRE

    Nagata, Takashi; Abe, Takeru; Noda, Eiichiro; Hasegawa, Manabu; Hashizume, Makoto; Hagihara, Akihito

    2014-01-01

    Objectives To better understand and predict clinical outcomes of paediatric out-of-hospital cardiac arrest (OHCA). Design A population-based, observational study. Setting The National Japan Utstein Registry. Participants 2900 children aged 5–17 years who experienced OHCA and received resuscitation by emergency responders. Signal detection analysis using 17 variables was applied to identify factors associated with OHCA outcomes; the primary endpoint was cerebral performance category (CPC) 1 or...

  4. CT Follow-Up and Clinical Outcome in Severe Traumatic Injury Patients

    OpenAIRE

    Belina, Stanko; Kovačić, Sanja

    2011-01-01

    Determining a patient’s prognosis after severe traumatic brain injury remains difficult and complex. The purpose of the present study was following up patients with severe traumatic brain injury by correlating their clinical outcome and sequential computer tomography (CT) findings. We investigated 51 patients who survived the first year following an accident. All patients underwent successive CT examinations within a maximum period of 2 years. The patients’ outcomes depended on th...

  5. Clinical capabilities of graduates of an outcomes-based integrated medical program

    OpenAIRE

    Scicluna Helen A; Grimm Michael C; O’Sullivan Anthony J; Harris Peter; Pilotto Louis S; Jones Philip D; McNeil H

    2012-01-01

    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 r...

  6. Do clinical foot and ankle assessments improve the prediction of patient reported outcomes in knee arthroplasty?

    OpenAIRE

    Gates, Lucy

    2015-01-01

    Knee arthroplasty (KA) has been considered to be a successful and cost-effective intervention for individuals with severe end stage Osteoarthritis (OA). A number of clinically important predictors of outcomes following KA have been established, however there are still other factors to be identified to improve our ability to recognise patients at risk of poor KA outcomes. Although the relationship between foot, ankle and knee kinematics has become widely accepted, it is not known whether foot ...

  7. Optimizing Drug Prescribing in Managed Care Populations: Improving Clinical and Economic Outcomes

    OpenAIRE

    Rachel Czubak; Jasmine Tucker; Zarowitz, Barbara J.

    2004-01-01

    Managed care presents interesting opportunities to optimize clinical and economic outcomes related to drug prescribing. There are very few randomized controlled trials that have evaluated methods to educate or incentivize physicians, implement formulary management or guideline tools, profile physicians, and implement pharmacist interventions to ensure optimal drug prescribing. Single methods of optimizing medication outcomes have not been shown to be as effective as multifaceted approaches. S...

  8. Regulatory T cells, inherited variation, and clinical outcome in epithelial ovarian cancer.

    Science.gov (United States)

    Knutson, Keith L; Maurer, Matthew J; Preston, Claudia C; Moysich, Kirsten B; Goergen, Krista; Hawthorne, Kieran M; Cunningham, Julie M; Odunsi, Kunle; Hartmann, Lynn C; Kalli, Kimberly R; Oberg, Ann L; Goode, Ellen L

    2015-12-01

    The immune system constitutes one of the host factors modifying outcomes in ovarian cancer. Regulatory T cells (Tregs) are believed to be a major factor in preventing the immune response from destroying ovarian cancers. Understanding mechanisms that regulate Tregs in the tumor microenvironment could lead to the identification of novel targets aimed at reducing their influence. In this study, we used immunofluorescence-based microscopy to enumerate Tregs, total CD4 T cells, and CD8(+) cytotoxic T cells in fresh frozen tumors from over 400 patients with ovarian cancer (>80 % high-grade serous). We sought to determine whether Tregs were associated with survival and genetic variation in 79 genes known to influence Treg induction, trafficking, or function. We used Cox regression, accounting for known prognostic factors, to estimate hazard ratios (HRs) associated with T cell counts and ratios. We found that the ratios of CD8 T cells and total CD4 T cells to Tregs were associated with improved overall survival (CD8/Treg HR 0.84, p = 0.0089; CD4/Treg HR 0.88, p = 0.046) and with genetic variation in IL-10 (p = 0.0073 and 0.01, respectively). In multivariate analyses, the associations between the ratios and overall survival remained similar (IL-10 and clinical covariate-adjusted CD8/Treg HR 0.85, p = 0.031; CD4/Treg HR 0.87, p = 0.093), suggesting that this association was not driven by variation in IL-10. Thus, integration of novel tumor phenotyping measures with extensive clinical and genetic information suggests that the ratio of T cells to Tregs may be prognostic of outcome in ovarian cancer, regardless of inherited genotype in genes related to Tregs. PMID:26298430

  9. Pramipexole in restless legs syndrome: an evidence-based review of its effectiveness on clinical outcomes

    Directory of Open Access Journals (Sweden)

    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

  10. 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.

  11. Dandy-walker malformation: A clinical and surgical outcome analysis

    International Nuclear Information System (INIS)

    Objective: To determine the clinical presentations, complications and mortality in patients with Dandy-Walker Malformation (DWM) after surgery i.e., shunt with y-connector. Study Design: Case series. Place and duration of study: Neurosurgery Ward, JPMC, Karachi, from January 2009 to December 2013. Methodology: Cases of DWM, with associated hydrocephalus, further confirmed on CT scan of brain, were admitted through OPD. Those who were previously operated, those with other associated co-morbid or anomalies were excluded from this study. Combined drainage of the ventricular system and posterior fossa cyst, via dual shunt i.e. cystoperitoneal and ventriculoperitoneal shunt with y-connector was performed in all patients. Complications and mortality after surgical intervention in these patients were noted upto one month after surgery. The data analysis for descriptive statistics was done on SPSS version 20. Results: In this study of 70 patients, majority of the patients were female aged between 1 - 2 years. Hydrocephalus was the predominant symptom as being present in all patients, followed by cerebellar signs in 60 (86%), and other in 5 (7.14%) patients. Complications of surgery were infection and shunt fracture dislocation in 7 (10%) each, malpositioning and shunt blockage in 6 (8.5%) each within one month of surgery, intracranial haemorrhage in 5 (7.14%) patients. Only one patient (1.42%) expired after surgical intervention. Conclusion: In DWM, the commonest presentation is that of hydrocephalus. Shunt malfunction and infection are the commonest complication after shunting. Dual shunt with y-connector has the lowest mortality when compared with other methods for treatment of shunt with y-connector. (author)

  12. Clinical capabilities of graduates of an outcomes-based integrated medical program

    Directory of Open Access Journals (Sweden)

    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

  13. Health-related quality of life measurement in pediatric clinical practice: An appraisal and precept for future research and application

    OpenAIRE

    Lane Mariella M; Burwinkle Tasha M; Varni James W

    2005-01-01

    Abstract Health-related quality of life (HRQOL) measurement has emerged as an important health outcome in clinical trials, clinical practice improvement strategies, and healthcare services research and evaluation. HRQOL measures are also increasingly proposed for use in clinical practice settings to inform treatment decisions. In settings where HRQOL measures have been utilized with adults, physicians report such measures as useful, some physicians alter their treatment based on patient repor...

  14. Early clinical outcome and complications related to balloon kyphoplasty

    Directory of Open Access Journals (Sweden)

    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

  15. Autism spectrum disorder genetics: diverse genes with diverse clinical outcomes.

    Science.gov (United States)

    Talkowski, Michael E; Minikel, Eric Vallabh; Gusella, James F

    2014-01-01

    has been remarkable and increasingly rapid, but the interactive impact of strong-effect genetic lesions coupled with weak-effect common polymorphisms has not yet led to a unified understanding of ASD pathogenesis or explained its highly variable clinical expression. With an increasingly firm genetic foundation, the coming years will hopefully see equally rapid advances in elucidating the functional consequences of ASD genes and their interactions with environmental/experiential factors, supporting the development of rational interventions. PMID:24614762

  16. 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.

  17. Correlation of clinical outcome to the estimated radiation dose from Boron Neutron Capture Therapy (BNCT)

    International Nuclear Information System (INIS)

    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

  18. 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

    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...... immediately following graduation. Results: Invitation to participate was accepted by 154/240 (64%) graduates and 117/154 (76%) completed the study. There was no difference between the intervention and control groups with regard to the imme- diate learning outcome. The intervention group had significantly...... small but statistically significant impact on the retention of learning, but not on the immediate learning outcome....

  19. Ischemic Stroke: Risk Stratification, Warfarin Teatment and Outcome Measure

    Directory of Open Access Journals (Sweden)

    Srikanth Kaithoju

    2015-12-01

    Full Text Available Stroke is a focal neurological syndrome of vascular basis, which may be due to ischemic thrombo-embolism or intra-cerebral haemorrhage. This condition has to be treated on emergency basis as it may cause an irreversible neurological damage. Warfarin has been a widely used oral anti-coagulant in treating ischemic stroke patients. This review highlights the benefits and challenges of warfarin treatment in stroke patients and discusses about the importance of risk stratification scores & bleeding scores in estimating the bleeding risk associated with warfarin treatment. This review also highlights the use of stroke outcome measures in identifying the patients with post-stroke disabilities to provide patient specific treatment.

  20. Using the bootstrap to establish statistical significance for relative validity comparisons among patient-reported outcome measures

    OpenAIRE

    Deng, Nina; Allison, Jeroan J; Fang, Hua Julia; Ash, Arlene S.; Ware, John E.

    2013-01-01

    Background Relative validity (RV), a ratio of ANOVA F-statistics, is often used to compare the validity of patient-reported outcome (PRO) measures. We used the bootstrap to establish the statistical significance of the RV and to identify key factors affecting its significance. Methods Based on responses from 453 chronic kidney disease (CKD) patients to 16 CKD-specific and generic PRO measures, RVs were computed to determine how well each measure discriminated across clinically-defined groups ...

  1. Guest Editorial: Rehabilitation Research and Development state-of-the-art conference on outcome measures in rehabilitation

    OpenAIRE

    Timothy R. Elliott, PhD, ABPP

    2012-01-01

    In January 2010, the Veterans Health Administration (VHA) Office of Research and Development brought clinical, scientific, and policy experts from a variety of professions to Miami, Florida, for a 3-day State-of-the-Art (SOTA) Conference on outcome measures in rehabilitation. The need for such a SOTA is obvious in light of the clinical complexity and long-term nature of injuries incurred by service personnel returning from international conflicts, combined with the ongoing commitment to aging...

  2. The quantification of dynamic FET PET imaging and correlation with the clinical outcome in patients with glioblastoma

    Science.gov (United States)

    Thiele, Frank; Ehmer, Julia; Piroth, Marc D.; Eble, Michael J.; Coenen, Heinz H.; Kaiser, Hans-Juergen; Schaefer, Wolfgang M.; Buell, Ulrich; Boy, Christian

    2009-09-01

    The PET tracer O-(2-[18F]Fluoroethyl)-l-tyrosine (FET) has been shown to be valuable for different roles in the management of brain tumours. The aim of this study was to evaluate several quantitative measures of dynamic FET PET imaging in patients with resected glioblastoma. We evaluated dynamic FET PET in nine patients with histologically confirmed glioblastoma. Following FET PET, all subjects had radiation and chemotherapy. Tumour ROIs were defined by a threshold-based region-growing algorithm. We compared several standard measures of tumour uptake and uptake kinetics: SUV, SUV/background, distribution volume ratio (DVR), weighted frame differences and compartment model parameters. These measures were correlated with disease-free and overall survival, and analysed for statistical significance. We found that several measures allowed robust quantification. SUV and distribution volume did not correlate with clinical outcome. Measures that are based on a background region (SUV/BG, Logan-DVR) highly correlated with disease-free survival (r = -0.95, p survival. Some advanced measures also showed a prognostic value but no improvement over the simpler methods. We conclude that FET PET probably has a prognostic value in patients with resected glioblastoma. The ratio of SUV to background may provide a simple and valuable predictive measure of the clinical outcome. Further studies are needed to confirm these explorative results.

  3. 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

  4. Correlation between Circulating Fungal Biomarkers and Clinical Outcome in Invasive Aspergillosis.

    Directory of Open Access Journals (Sweden)

    Dionysios Neofytos

    Full Text Available Objective means are needed to predict and assess clinical response in patients treated for invasive aspergillosis (IA. We examined whether early changes in serum galactomannan (GM and/or β-D-glucan (BDG can predict clinical outcomes. Patients with proven or probable IA were prospectively enrolled, and serial GM and BDG levels and GM optical density indices (GMI were calculated twice weekly for 6 weeks following initiation of standard-of-care antifungal therapy. Changes in these biomarkers during the first 2 and 6 weeks of treatment were analyzed for associations with clinical response and survival at weeks 6 and 12. Among 47 patients with IA, 53.2% (25/47 and 65.9% (27/41 had clinical response by weeks 6 and 12, respectively. Changes in biomarkers during the first 2 weeks were associated with clinical response at 6 weeks (GMI, P = 0.03 and 12 weeks (GM+BDG composite, P = 0.05; GM, P = 0.04; GMI, P = 0.02. Changes in biomarkers during the first 6 weeks were also associated with clinical response at 6 weeks (GM, P = 0.05; GMI, P = 0.03 and 12 weeks (BDG+GM, P = 0.02; GM, P = 0.02; GMI, P = 0.01. Overall survival rates at 6 weeks and 12 weeks were 87.2% (41/47 and 79.1% (34/43, respectively. Decreasing biomarkers in the first 2 weeks were associated with survival at 6 weeks (BDG+GM, P = 0.03; BDG, P = 0.01; GM, P = 0.03 and at 12 weeks (BDG+GM, P = 0.01; BDG, P = 0.03; GM, P = 0.01; GMI, P = 0.007. Similar correlations occurred for biomarkers measured over 6 weeks. Patients with negative baseline GMI and/or persistently negative GMI during the first 2 weeks were more likely to have CR and survival. These results suggest that changes of biomarkers may be informative to predict and/or assess response to therapy and survival in patients treated for IA.

  5. 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

  6. Early seizures in patients with acute stroke: Frequency, predictive factors, and effect on clinical outcome

    OpenAIRE

    Andrea Alberti; Maurizio Paciaroni; Valeria Caso; Michele Venti; Francesco Palmerini; Giancarlo Agnelli

    2008-01-01

    Andrea Alberti, Maurizio Paciaroni, Valeria Caso, Michele Venti, Francesco Palmerini, Giancarlo AgnelliStroke Unit and Division of Internal and Cardiovascular Medicine, University of Perugia, Perugia, ItalyBackground: Early seizure (ES) may complicate the clinical course of patients with acute stroke. The aim of this study was to assess the rate of and the predictive factors for ES as well the effects of ES on the clinical outcome at hospital discharge in patients with first-ever stroke.Patie...

  7. Prospective study on the clinical course and outcomes in transfusion-related acute lung injury

    OpenAIRE

    Looney, MR; Roubinian, N; Gajic, O; Gropper, MA; Hubmayr, RD; Lowell, CA; Bacchetti, P.; Wilson, G.; Koenigsberg, M; Lee, DC; Wu, P; Grimes, B; Norris, PJ; Murphy, EL; Gandhi, MJ

    2014-01-01

    OBJECTIVE:: Transfusion-related acute lung injury is the leading cause of transfusion-related mortality. A prospective study using electronic surveillance was conducted at two academic medical centers in the United States with the objective to define the clinical course and outcomes in transfusion-related acute lung injury cases. DESIGN:: Prospective case study with controls. SETTING:: University of California, San Francisco and Mayo Clinic, Rochester. PATIENTS:: We prospectively enrolled 89 ...

  8. Epidemiology and Clinical Outcomes of Patients with Carbapenem-Resistant Klebsiella pneumoniae Bacteriuria

    OpenAIRE

    Qureshi, Zubair A.; Syed, Alveena; Clarke, Lloyd G.; Doi, Yohei; Shields, Ryan K.

    2014-01-01

    Carbapenem-resistant Klebsiella pneumoniae (CRKP) bacteriuria is a frequently encountered clinical condition, but its clinical impact is unknown. We conducted a retrospective cohort study to define the epidemiology and outcomes for patients with CRKP bacteriuria. Patients with positive urine cultures for CRKP were classified as having asymptomatic bacteriuria (ASB) or symptomatic urinary tract infection (UTI). Among 105 patients with CRKP bacteriuria, 80% (84/105 patients) and 20% (21/105 pat...

  9. Clinical features and outcomes of autoimmune hemolytic anemia: a retrospective analysis of 32 cases

    OpenAIRE

    Baek, Seung-Woo; Lee, Myung-Won; Ryu, Hae-Won; Lee, Kyu-Seop; SONG, IK-CHAN; Lee, Hyo-Jin; Yun, Hwan-Jung; Kim, Samyong; Jo, Deog-Yeon

    2011-01-01

    Background There has been no report on the clinical features or natural history of autoimmune hemolytic anemia (AIHA) in the Korean adult population. This study retrospectively analyzed the clinical characteristics and long-term outcomes of AIHA in the Korean adults. Methods Patients newly diagnosed with AIHA between January 1994 and December 2010 at Chungnam National University Hospital were enrolled. Patient characteristics at diagnosis, response to treatment, and the natural course of the ...

  10. Clinical application of 3D imaging for assessment of treatment outcomes

    OpenAIRE

    Cevidanes, Lucia H.C.; Oliveira, Ana Emilia Figueiredo; Grauer, Dan; Styner, Martin; Proffit, William R.

    2011-01-01

    This paper outlines the clinical application of CBCT for assessment of treatment outcomes, and discusses current work to superimpose digital dental models and 3D photographs. Superimposition of CBCTs on stable structures of reference now allow assessment of 3D dental, skeletal and soft tissue changes for both growing and non-growing patients. Additionally, we describe clinical findings from CBCT superimpositions in assessment of surgery and skeletal anchorage treatment.

  11. Clinical variables and implications of the personality on the outcome of bipolar illness: a pilot study

    OpenAIRE

    Casas-Barquero, Nieves; García-López, Olga; Fernández-Argüelles, Pedro; Camacho-Laraña, Manuel

    2007-01-01

    Outcome in bipolar patients is affected by comorbidity. Comorbid personality disorders are frequent and may complicate the course of bipolar illness. This pilot study examined a series of 40 euthymic bipolar patients (DSM-IV criteria) (bipolar I disorder 31, bipolar II disorder 9) to assess the effect of clinical variables and the influence of comorbid personality on the clinical course of bipolar illness. Bipolar patients with a diagnosis of comorbid personality disorder (n = 30) were compar...

  12. Pulmonary embolism in intensive care unit: Predictive factors, clinical manifestations and outcome

    OpenAIRE

    Bahloul Mabrouk; Chaari Anis; Kallel Hatem; Abid Leila; Hamida Chokri Ben; Dammak Hassen; Rekik Noureddine; Mnif Jameleddine; Chelly Hedi; Bouaziz Mounir

    2010-01-01

    Objective : To determine predictive factors, clinical and demographics characteristics of patients with pulmonary embolism (PE) in ICU, and to identify factors associated with poor outcome in the hospital and in the ICU. Methods : During a four-year prospective study, a medical committee of six ICU physicians prospectively examined all available data for each patient in order to classify patients according to the level of clinical suspicion of pulmonary thromboembolism. During the study...

  13. Clinical profile and outcome of Hantavirus infection with renal involvement in India

    OpenAIRE

    Alok Kumar; Dorchhom Khrime; Nitin Bansal; Amar Nath Pandey; Shakeel Ahmad; Varma Amit

    2014-01-01

    Background: Hantavirus infections are found all over world but there is paucity of information about clinical features of Hantavirus infection in India. Aim of current study was to study clinical profile and outcome of patients with Hantavirus infection and renal insufficiency who presented at our institute. Methods: All patients who were admitted in department of medicine with Hantavirus infection and renal insufficiency were included. Their basic demographic profile with relevant labora...

  14. Testing for heterogeneity among the components of a binary composite outcome in a clinical trial

    Directory of Open Access Journals (Sweden)

    Devereaux PJ

    2010-06-01

    Full Text Available Abstract Background Investigators designing clinical trials often use composite outcomes to overcome many statistical issues. Trialists want to maximize power to show a statistically significant treatment effect and avoid inflation of Type I error rate due to evaluation of multiple individual clinical outcomes. However, if the treatment effect is not similar among the components of this composite outcome, we are left not knowing how to interpret the treatment effect on the composite itself. Given significant heterogeneity among these components, a composite outcome may be judged as being invalid or un-interpretable for estimation of the treatment effect. This paper compares the power of different tests to detect heterogeneity of treatment effect across components of a composite binary outcome. Methods Simulations were done comparing four different models commonly used to analyze correlated binary data. These models included: logistic regression for ignoring correlation, logistic regression weighted by the intra cluster correlation coefficient, population average logistic regression using generalized estimating equations (GEE, and random effects logistic regression. Results We found that the population average model based on generalized estimating equations (GEE had the greatest power across most scenarios. Adequate power to detect possible composite heterogeneity or variation between treatment effects of individual components of a composite outcome was seen when the power for detecting the main study treatment effect for the composite outcome was also reasonably high. Conclusions It is recommended that authors report tests of composite heterogeneity for composite outcomes and that this accompany the publication of the statistically significant results of the main effect on the composite along with individual components of composite outcomes.

  15. 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....

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

    OpenAIRE

    Mokkink, Lidwine B; Prinsen, Cecilia A C; Bouter, Lex M; de Vet, Henrica C. W.; Terwee, Caroline B

    2016-01-01

    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 checkli...

  17. Blood Pressure Measurement: Clinic, Home, Ambulatory, and Beyond

    OpenAIRE

    Drawz, Paul E; ABDALLA, MOHAMED; Rahman, Mahboob

    2012-01-01

    Blood pressure has traditionally been measured in the clinic setting using the auscultory method and a mercury sphygmomanometer. Technological advances have led to improvements in measuring clinic blood pressure and allowed for measuring blood pressures outside the clinic. This review outlines various methods for evaluating blood pressure and the clinical utility of each type of measurement. Home blood pressures and 24 hour ambulatory blood pressures have improved our ability to evaluate risk...

  18. 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.

  19. Clinical and radiological outcomes after management of traumatic knee dislocation by open single stage complete reconstruction/repair

    Directory of Open Access Journals (Sweden)

    Lorez Lukas G

    2010-05-01

    Full Text Available Abstract Background The purpose of our study was to analyze the clinical and radiological long-term outcomes of surgically treated traumatic knee dislocations and determine prognostic factors for outcome. Methods Retrospective consecutive series of patients treated surgically for traumatic knee dislocation with reconstruction/refixation of the anterior (ACL and posterior cruciate ligaments (PCL and primary complete repair of collaterals and posteromedial and posteromedial corner structures. 68 patients were evaluated clinically (IKDC score, SF36 health survey, Lysholm score, Knee Society score, Tegner score, visual analogue scale - VAS pain and satisfaction, Cooper test and radiologically (weight bearing and stress radiographs with a mean follow up of 12 ± 8 years. Instrumented anterior-posterior translation was measured (Rolimeter, KT-1000. Pearson correlation and stepwise regression analysis was used. Results 82% of patients (n = 56 returned to their previous work. At final follow-up 6 patients (9% suffered from pain VAS > 3. The mean side-to-side difference of anterior/posterior translation (KT-1000, 134N was 1.6 ± 1.6 mm and 2.6 ± 1.4 mm. Valgus and varus stress testing in 30° flexion was 40 days were significantly associated with worse outcome (p Conclusions Early complete reconstruction can achieve good functional results and patient satisfaction with overall restoration of sports and working capacity. Negative predictive factors for outcome were injury pattern, type of surgical procedure and timing of surgery.

  20. Clinical Outcomes and Complications of Cortical Button Distal Biceps Repair: A Systematic Review of the Literature

    Directory of Open Access Journals (Sweden)

    Andreas Panagopoulos

    2016-01-01

    Full Text Available Objectives. The purpose of the present study was to investigate the clinical outcomes and complications of the cortical button distal biceps fixation method. Material and Methods. All methods followed the PRISMA guidelines. Included studies had to describe clinical outcomes and complications after acute distal biceps repair with cortical button fixation. Eligibility criteria also included English language, more than 5 cases with minimum follow-up of 6 months, and preferably usage of at least one relevant clinical score (MEPS, ASES, and/or DASH for final outcome. A loss of at least 30° in motion—flexion, extension, pronation, or supination—and a loss of at least 30% of strength were considered an unsatisfactory result. Results. The review identified 7 articles including 105 patients (mean age 43.6 years with 106 acute distal biceps ruptures. Mean follow-up was 26.3 months. Functional outcome of ROM regarding flexion/extension and pronation/supination was satisfactory in 94 (89.5% and 86 (82% patients in respect. Averaged flexion and supination strength had been reported in 6/7 studies (97 patients and were satisfactory in 82.4% of them. The most common complication was transient nerve palsy (14.2%. The overall reoperation rate was 4.8% (5/105 cases. Conclusion. Cortical button fixation for acute distal biceps repair is a reproducible operation with good clinical results. Most of the complications can be avoided with appropriate surgical technique.

  1. Relationship Between Upper Respiratory Tract Influenza Test Result and Clinical Outcomes Among Critically Ill Influenza Patients

    OpenAIRE

    Reddy, Krishna P.; Bajwa, Ednan K.; Parker, Robert A.; Andrew B Onderdonk; Walensky, Rochelle P.

    2016-01-01

    Among critically ill patients with lower respiratory tract (LRT)-confirmed influenza, we retrospectively observed worse 28-day clinical outcomes in upper respiratory tract (URT)-negative versus URT-positive subjects. This finding may reflect disease progression and highlights the need for influenza testing of both URT and LRT specimens to improve diagnostic yield and possibly inform prognosis.

  2. Clinical Outcome and Mechanisms of Deep Brain Stimulation for Obsessive-Compulsive Disorder

    NARCIS (Netherlands)

    van Westen, Maarten; Rietveld, Erik; Figee, Martijn; Denys, D.

    2015-01-01

    Clinical outcome of deep brain stimulation (DBS) for obsessive-compulsive disorder (OCD) shows robust effects in terms of a mean Yale-Brown Obsessive-Compulsive Scale (YBOCS) reduction of 47.7 % and a mean response percentage (minimum 35 % YBOCS reduction) of 58.2 %. It appears that most patients re

  3. A prospective clinical study of feto-maternal outcome in pregnancies with abnormal liquor volume

    Directory of Open Access Journals (Sweden)

    Rutwa J. Chavda

    2014-02-01

    Conclusions: A good clinical examination can pick up most subjects of abnormal liquor volume. Abnormal liquor volumes are associated with increased maternal morbidity and adverse perinatal outcome. [Int J Reprod Contracept Obstet Gynecol 2014; 3(1.000: 181-184

  4. Low Plasma alpha-Tocopherol Concentrations and Adverse Clinical Outcomes in Diabetic Hemodialysis Patients

    NARCIS (Netherlands)

    Espe, Katharina M.; Raila, Jens; Henze, Andrea; Blouin, Katja; Schneider, Andreas; Schmiedeke, Daniel; Krane, Vera; Pilz, Stefan; Schweigert, Florian J.; Hocher, Berthold; Wanner, Christoph; Drechsler, Christiane

    2013-01-01

    Background and objectives Trials with the antioxidant vitamin E have failed to show benefit in the general population. Considering the different causes of death in ESRD, this study investigated the association between plasma concentrations of alpha-tocopherol and specific clinical outcomes in diabet

  5. 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...

  6. 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.

  7. 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…

  8. 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

  9. Ultrasound as an Outcome Measure in Gout. A Validation Process by the OMERACT Ultrasound Working Group

    DEFF Research Database (Denmark)

    Terslev, Lene; Gutierrez, Marwin; Schmidt, Wolfgang A;

    2015-01-01

    OBJECTIVE: To summarize the work performed by the Outcome Measures in Rheumatology (OMERACT) Ultrasound (US) Working Group on the validation of US as a potential outcome measure in gout. METHODS: Based on the lack of definitions, highlighted in a recent literature review on US as an outcome tool in...

  10. Towards global consensus on outcome measures for atopic eczema research : Results of the HOME II meeting

    NARCIS (Netherlands)

    Schmitt, Jochen; Spuls, Phyllis; Boers, Maarten; Thomas, Kim; Chalmers, Joanne; Roekevisch, Evelien; Schram, Mandy; Allsopp, Richard; Aoki, Valeria; Apfelbacher, Christian; Bruijnzeel-Koomen, Carla; Bruin-Weller, Marjolein; Charman, Carolyn; Cohen, Arnon; Dohil, Magdalene; Flohr, Carsten; Furue, Masutaka; Gieler, Uwe; Hooft, Lotty; Humphreys, Rosemary; Ishii, Henrique Akira; Katayama, Ichiro; Kouwenhoven, Willem; Langan, Sinéad; Lewis-Jones, Sue; Merhand, Stephanie; Murota, Hiroyuki; Murrell, Dedee F; Nankervis, Helen; Ohya, Yukihiro; Oranje, Arnold; Otsuka, Hiromi; Paul, Carle; Rosenbluth, Yael; Saeki, Hidehisa; Schuttelaar, Marie-Louise; Stalder, Jean-Francois; Svensson, Ake; Takaoka, Roberto; Wahlgren, Carl-Fredrik; Weidinger, Stephan; Wollenberg, Andreas; Williams, Hywel

    2012-01-01

    The use of nonstandardized and inadequately validated outcome measures in atopic eczema trials is a major obstacle to practising evidence-based dermatology. The Harmonising Outcome Measures for Eczema (HOME) initiative is an international multiprofessional group dedicated to atopic eczema outcomes r

  11. 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…

  12. How can we improve outcomes for patients and families under palliative care? implementing clinical audit for quality improvement in resource limited settings

    Directory of Open Access Journals (Sweden)

    Lucy Selman

    2010-01-01

    Full Text Available Palliative care in India has made enormous advances in providing better care for patients and families living with progressive disease, and many clinical services are well placed to begin quality improvement initiatives, including clinical audit. Clinical audit is recognized globally to be essential in all healthcare, as a way of monitoring and improving quality of care. However, it is not common in developing country settings, including India. Clinical audit is a cyclical activity involving: identification of areas of care in need of improvement, through data collection and analysis utilizing an appropriate questionnaire; setting measurable quality of care targets in specific areas; designing and implementing service improvement strategies; and then re-evaluating quality of care to assess progress towards meeting the targets. Outcome measurement is an important component of clinical audit that has additional advantages; for example, establishing an evidence base for the effectiveness of services. In resource limited contexts, outcome measurement in clinical audit is particularly important as it enables service development to be evidence-based and ensures resources are allocated effectively. Key success factors in conducting clinical audit are identified (shared ownership, training, managerial support, inclusion of all members of staff and a positive approach. The choice of outcome measurement tool is discussed, including the need for a culturally appropriate and validated measure which is brief and simple enough to incorporate into clinical practice and reflects the holistic nature of palliative care. Support for clinical audit is needed at a national level, and development and validation of an outcome measurement tool in the Indian context is a crucial next step.

  13. 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 ...

  14. Establishing a new falls clinic - conflicting attitudes and inter-sectoral competition affecting the outcome

    DEFF Research Database (Denmark)

    Evron, Lotte; Schultz-Larsen, Kirsten; Egerod, Ingrid

    2008-01-01

    Scand J Caring Sci; 2008 Establishing a new falls clinic - conflicting attitudes and inter-sectoral competition affecting the outcomeFalls clinics are a newer model for falls management among the elderly. Few studies have addressed the impact of the strategy on falls prevention in the healthcare...... system. The aim of the present study was to describe the social processes that affect the implementation of new strategies in falls management. A newly established falls clinic was chosen as an instrumental case to describe the systematic and comprehensive approach to falls prevention among the elderly...

  15. Post-Exercise Heart Rate Recovery Independently Predicts Clinical Outcome in Patients with Acute Decompensated Heart Failure

    Science.gov (United States)

    Youn, Jong-Chan; Lee, Hye Sun; Choi, Suk-Won; Han, Seong-Woo; Ryu, Kyu-Hyung; Shin, Eui-Cheol; Kang, Seok-Min

    2016-01-01

    Background Post-exercise heart rate recovery (HRR) is an index of parasympathetic function associated with clinical outcome in patients with chronic heart failure. However, its relationship with the pro-inflammatory response and prognostic value in consecutive patients with acute decompensated heart failure (ADHF) has not been investigated. Methods We measured HRR and pro-inflammatory markers in 107 prospectively and consecutively enrolled, recovered ADHF patients (71 male, 59 ± 15 years, mean ejection fraction 28.9 ± 14.2%) during the pre-discharge period. The primary endpoint included cardiovascular (CV) events defined as CV mortality, cardiac transplantation, or rehospitalization due to HF aggravation. Results The CV events occurred in 30 (28.0%) patients (5 cardiovascular deaths and 7 cardiac transplantations) during the follow-up period (median 214 days, 11–812 days). When the patients with ADHF were grouped by HRR according to the Contal and O’Quigley’s method, low HRR was shown to be associated with significantly higher levels of serum monokine-induced by gamma interferon (MIG) and poor clinical outcome. Multivariate Cox regression analysis revealed that low HRR was an independent predictor of CV events in both enter method and stepwise method. The addition of HRR to a model significantly increased predictability for CV events across the entire follow-up period. Conclusion Impaired post-exercise HRR is associated with a pro-inflammatory response and independently predicts clinical outcome in patients with ADHF. These findings may explain the relationship between autonomic dysfunction and clinical outcome in terms of the inflammatory response in these patients. PMID:27135610

  16. Clinical features, predictive factors and outcome of hyperglycaemic emergencies in a developing country

    Directory of Open Access Journals (Sweden)

    Unachukwu Chioma

    2009-03-01

    Full Text Available Abstract Background Hyperglycaemic emergencies are common acute complications of diabetes mellitus (DM but unfortunately, there is a dearth of published data on this entity from Nigeria. This study attempts to describe the clinical and laboratory scenario associated with this complication of DM. Methods This study was carried out in DM patients who presented to an urban hospital in Nigeria with hyperglycaemic emergencies (HEs. The information extracted included biodata, laboratory data and hospitalization outcome. Outcome measures included mortality rates, case fatality rates and predictive factors for HEs mortality. Statistical tests used are χ2, Student's t test and logistic regression. Results A total of 111 subjects with HEs were recruited for the study. Diabetes ketoacidosis (DKA and hyperosomolar hyperglycaemic state (HHS accounted for 94 (85% and 17 (15% respectively of the HEs. The mean age (SD of the subjects was 53.9 (14.4 years and their ages ranged from 22 to 86 years. DKA occurred in all subjects with type 1 DM and 73 (81% of subjects with type 2 DM. The presence of HSS was noted in 17 (19% of the subjects with type 2 DM. Hypokalaemia (HK was documented in 41 (37% of the study subjects. Elevated urea levels and hyponatraemia were noted more in subjects with DKA than in those subjects with HHS (57.5%,19% vs 53%,18%. The mortality rate for HEs in this report is 20% and the case fatality rates for DKA and HHS are 18% and 35% respectively. The predictive factors for HEs mortality include, sepsis, foot ulceration, previously undetected DM, hypokalaemia and being elderly. Conclusion HHS carry a higher case fatality rate than DKA and the predictive factors for hyperglycaemic emergencies' mortality in the Nigerian with DM include foot ulcers, hypokalaemia and being elderly.

  17. 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 

  18. CD19-targeted CAR T-cell therapeutics for hematologic malignancies: interpreting clinical outcomes to date.

    Science.gov (United States)

    Park, Jae H; Geyer, Mark B; Brentjens, Renier J

    2016-06-30

    Adoptive transfer of T cells genetically modified to express chimeric antigen receptors (CARs) targeting CD19 has produced impressive results in treating patients with B-cell malignancies. Although these CAR-modified T cells target the same antigen, the designs of CARs vary as well as several key aspects of the clinical trials in which these CARs have been studied. It is unclear whether these differences have any impact on clinical outcome and treatment-related toxicities. Herein, we review clinical results reflecting the investigational use of CD19-targeted CAR T-cell therapeutics in patients with B-cell hematologic malignancies, in light of differences in CAR design and production, and outline the limitations inherent in comparing outcomes between studies. PMID:27207800

  19. Individual-level outcomes from a national clinical leadership development programme.

    Science.gov (United States)

    Patton, Declan; Fealy, Gerard; McNamara, Martin; Casey, Mary; Connor, Tom O; Doyle, Louise; Quinlan, Christina

    2013-08-01

    A national clinical leadership development programme was instituted for Irish nurses and midwives in 2010. Incorporating a development framework and leadership pathway and a range of bespoke interventions for leadership development, including workshops, action-learning sets, mentoring and coaching, the programme was introduced at seven pilot sites in the second half of 2011. The programme pilot was evaluated with reference to structure, process and outcomes elements, including individual-level programme outcomes. Evaluation data were generated through focus groups and group interviews, individual interviews and written submissions. The data provided evidence of nurses' and midwives' clinical leadership development through self and observer-reported behaviours and dispositions including accounts of how the programme participants developed and displayed particular clinical leadership competencies. A key strength of the new programme was that it involved interventions that focussed on specific leadership competencies to be developed within the practice context. PMID:24099226

  20. 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.

  1. Definitions and outcome measures for bullous pemphigoid: Recommendations by an international panel of experts

    Science.gov (United States)

    Murrell, Dedee F.; Daniel, Benjamin S.; Joly, Pascal; Borradori, Luca; Amagai, Masayuki; Hashimoto, Takashi; Caux, Frédéric; Marinovic, Branka; Sinha, Animesh A.; Hertl, Michael; Bernard, Philippe; Sirois, David; Cianchini, Giuseppe; Fairley, Janet A.; Jonkman, Marcel F.; Pandya, Amit G.; Rubenstein, David; Zillikens, Detlef; Payne, Aimee S.; Woodley, David; Zambruno, Giovanna; Aoki, Valeria; Pincelli, Carlo; Diaz, Luis; Hall, Russell P.; Meurer, Michael; Mascaro, Jose M.; Schmidt, Enno; Shimizu, Hiroshi; Zone, John; Swerlick, Robert; Mimouni, Daniel; Culton, Donna; Lipozencic, Jasna; Bince, Benjamin; Grando, Sergei A.; Bystryn, Jean-Claude; Werth, Victoria P.

    2011-01-01

    Our scientific knowledge of bullous pemphigoid (BP) has dramatically progressed in recent years. However, despite the availability of various therapeutic options for the treatment of inflammatory diseases, only a few multicenter controlled trials have helped to define effective therapies in BP. A major obstacle in sharing multicenter-based evidences for therapeutic efforts is the lack of generally accepted definitions for the clinical evaluation of patients with BP. Common terms and end points of BP are needed so that experts in the field can accurately measure and assess disease extent, activity, severity, and therapeutic response, and thus facilitate and advance clinical trials. These recommendations from the International Pemphigoid Committee represent 2 years of collaborative efforts to attain mutually acceptable common definitions for BP and proposes a disease extent score, the BP Disease Area Index. These items should assist in the development of consistent reporting of outcomes in future BP reports and studies. PMID:22056920

  2. Evaluating complementary and alternative medicine interventions: in search of appropriate patient-centered outcome measures

    Directory of Open Access Journals (Sweden)

    Mallory Devon

    2006-11-01

    Full Text Available Abstract Background Central to the development of a sound evidence base for Complementary and Alternative Medicine (CAM interventions is the need for valid, reliable and relevant outcome measures to assess whether the interventions work. We assessed the specific needs for a database that would cover a wide range of outcomes measures for CAM research and considered a framework for such a database. Methods The study was a survey of CAM researchers, practitioners and students. An online questionnaire was emailed to the members of the Canadian Interdisciplinary Network for CAM Research (IN-CAM and the CAM Education and Research Network of Alberta (CAMera. The majority of survey questions were open-ended and asked about outcome measures currently used, outcome measures' assessment criteria, sources of information, perceived barriers to finding outcome measures and outcome domains of importance. Descriptive quantitative analysis and qualitative content analysis were used. Results One hundred and sixty-four completed surveys were received. Of these, 62 respondents reported using outcome measures in their CAM research and identified 92 different specific outcomes. The most important barriers were the fact that, for many health concepts, outcome measures do not yet exist, as well as issues related to accessibility of instruments. Important outcome domains identified included physical, psychological, social, spiritual, quality of life and holistic measures. Participants also mentioned the importance of individualized measures that assess unique patient-centered outcomes for each research participant, and measures to assess the context of healing and the process of healing. Conclusion We have developed a preliminary framework that includes all components of health-related outcomes. The framework provides a foundation for a larger, comprehensive collection of CAM outcomes. It fits very well in a whole systems perspective, which requires an expanded set of

  3. Motivation and Treatment Credibility Predicts Dropout, Treatment Adherence, and Clinical Outcomes in an Internet-Based Cognitive Behavioral Relaxation Program: A Randomized Controlled Trial

    OpenAIRE

    Alfonsson, Sven; Olsson, Erik Martin Gustaf; Hursti, Timo

    2016-01-01

    Background In previous research, variables such as age, education, treatment credibility, and therapeutic alliance have shown to affect patients’ treatment adherence and outcome in Internet-based psychotherapy. A more detailed understanding of how such variables are associated with different measures of adherence and clinical outcomes may help in designing more effective online therapy. Objective The aims of this study were to investigate demographical, psychological, and treatment-specific v...

  4. 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.

  5. Incidence and Effects of Polypharmacy on Clinical Outcome among Patients Aged 80+: A Five-Year Follow-Up Study.

    Directory of Open Access Journals (Sweden)

    Rong Wang

    Full Text Available Polypharmacy is a problem of growing interest in geriatrics with the increase in drug consumption in recent years, is defined according to the WHO criteria as the, ''concurrent use of five or more different prescription medication". We investigated the clinical characteristics of polypharmacy and identified the effects of polypharmacy on clinical outcome among patients aged 80+ admitted to Chinese PLA general hospital.Older men aged ≥80 years (n = 1562 were included in this study. The included participants attended a structured clinical examination and an interview carried out by a geriatrician and trained nurses. A follow-up survey in 2014 was carried out on survivors in the same way as in 2009. The clinical outcome measured were adverse drug reactions, falls, frailty, disability, cognitive impairment, mortality. The association between polypharmacy and clinical outcome was assessed by logistic regression.The mean (range age of the included participants was 85.2 (80-104 years. Medication exposure was reported by 100% of the population. Mean number of medications reported in this population was 9.56±5.68. The prevalence of polypharmacy (≥6 medications in the present study was 70%. At the time of the follow-up survey, an increase in the number of taken medicines had occurred among half of the survivors. The risk of different outcomes in relation to number of medications rises significantly, the odds ratios were 1.21 (95% confidence interval [CI]1.17-1.28 for adverse drug reactions, 1.18 (95% CI 1.10-1.26 for falls, 1.16 (95% CI 1.09-1.24 for disability, and 1.19 (95% CI 1.12-1.23 for mortality. There was no association between increasing number of medications and cognitive impairment.Our study demonstrates that polypharmacy is very common in the very old patients, and observed that number of medications was a factor associated with difference clinical outcome independently of the age, type of medications prescribed and accompanied

  6. Measuring Networking as an Outcome Variable in Undergraduate Research Experiences.

    Science.gov (United States)

    Hanauer, David I; Hatfull, Graham

    2015-01-01

    The aim of this paper is to propose, present, and validate a simple survey instrument to measure student conversational networking. The tool consists of five items that cover personal and professional social networks, and its basic principle is the self-reporting of degrees of conversation, with a range of specific discussion partners. The networking instrument was validated in three studies. The basic psychometric characteristics of the scales were established by conducting a factor analysis and evaluating internal consistency using Cronbach's alpha. The second study used a known-groups comparison and involved comparing outcomes for networking scales between two different undergraduate laboratory courses (one involving a specific effort to enhance networking). The final study looked at potential relationships between specific networking items and the established psychosocial variable of project ownership through a series of binary logistic regressions. Overall, the data from the three studies indicate that the networking scales have high internal consistency (α = 0.88), consist of a unitary dimension, can significantly differentiate between research experiences with low and high networking designs, and are related to project ownership scales. The ramifications of the networking instrument for student retention, the enhancement of public scientific literacy, and the differentiation of laboratory courses are discussed. PMID:26538387

  7. Those who have the gold make the evidence: how the pharmaceutical industry biases the outcomes of clinical trials of medications.

    Science.gov (United States)

    Lexchin, Joel

    2012-06-01

    Pharmaceutical companies fund the bulk of clinical research that is carried out on medications. Poor outcomes from these studies can have negative effects on sales of medicines. Previous research has shown that company funded research is much more likely to yield positive outcomes than research with any other sponsorship. The aim of this article is to investigate the possible ways in which bias can be introduced into research outcomes by drawing on concrete examples from the published literature. Poorer methodology in industry-funded research is not likely to account for the biases seen. Biases are introduced through a variety of measures including the choice of comparator agents, multiple publication of positive trials and non-publication of negative trials, reinterpreting data submitted to regulatory agencies, discordance between results and conclusions, conflict-of-interest leading to more positive conclusions, ghostwriting and the use of "seeding" trials. Thus far, efforts to contain bias have largely focused on more stringent rules regarding conflict-of-interest (COI) and clinical trial registries. There is no evidence that any measures that have been taken so far have stopped the biasing of clinical research and it's not clear that they have even slowed down the process. Economic theory predicts that firms will try to bias the evidence base wherever its benefits exceed its costs. The examples given here confirm what theory predicts. What will be needed to curb and ultimately stop the bias that we have seen is a paradigm change in the way that we treat the relationship between pharmaceutical companies and the conduct and reporting of clinical trials. PMID:21327723

  8. The Relationship Between Thyroxine Level and Short Term Clinical Outcome Among Sick Newborn Infants

    Directory of Open Access Journals (Sweden)

    Maliheh Kadivar

    2011-02-01

    Full Text Available Premature and critically sick infants frequently experience several interventions, including blood transfusions, parentral nutrition, and prescriptions during hospitalization that could affect the result of thyroid function test. This study aims to investigate the correlation between thyroxine level and clinical short term outcome among the newborn infants in the neonatal intensive care unit (NICU. We assessed serum levels of thyroxine and thyroid stimulating hormone of 99 neonates who were admitted in the NICU from September 1st 2004 to March 30th 2005. Number of patients with low thyroxin level (less than 6.5 µg/dl was determined and the relation between serum total thyroxine level and birth weight, gestational age, duration of hospitalization, clinical diagnosis, and final outcome was investigated. Short term outcome was considered as duration of hospitalization and discharge alive from hospital. Prevalence of hypothyroxinemia was 26 percent. Later assessment of thyroxine level within 3 weeks revealed normal level of this parameter (8.12 µg/dl ±1.36. Patients with lower gestational age and lower birth weight had lower thyroxine level (7.15 µg/dl ±2.56, and P=0.03, 6.72 µg/dl ±3.03, and P=0.08. Low thyroxine level was not associated with adverse short-term clinical outcome (mortality rates; 3(11% and 9(12%, and duration of hospitalization among 17.7±9.8 vs 16.7± 13.0 in patients with hypothyroxinemia and low thyroxine level respectively. Hypothyroxinemia has considerable prevalence in neonatal intensive care setting and is related with lower birth weight and gestational age. Whether thyroxin levels are a marker or mediator of short term clinical outcome remains to be determined by further studies.

  9. Identifying the barriers to conducting outcomes research in integrative health care clinic settings - a qualitative study

    Directory of Open Access Journals (Sweden)

    Findlay-Reece Barbara

    2010-01-01

    Full Text Available Abstract Background Integrative health care (IHC is an interdisciplinary blending of conventional medicine and complementary and alternative medicine (CAM with the purpose of enhancing patients' health. In 2006, we designed a study to assess outcomes that are relevant to people using such care. However, we faced major challenges in conducting this study and hypothesized that this might be due to the lack of a research climate in these clinics. To investigate these challenges, we initiated a further study in 2008, to explore the reasons why IHC clinics are not conducting outcomes research and to identify strategies for conducting successful in-house outcomes research programs. The results of the latter study are reported here. Methods A total of 25 qualitative interviews were conducted with key participants from 19 IHC clinics across Canada. Basic content analysis was used to identify key themes from the transcribed interviews. Results Barriers identified by participants fell into four categories: organizational culture, organizational resources, organizational environment and logistical challenges. Cultural challenges relate to the philosophy of IHC, organizational leadership and practitioner attitudes and beliefs. Participants also identified significant issues relating to their organization's lack of resources such as funding, compensation, infrastructure and partnerships/linkages. Environmental challenges such as the nature of a clinic's patient population and logistical issues such as the actual implementation of a research program and the applicability of research data also posed challenges to the conduct of research. Embedded research leadership, integration of personal and professional values about research, alignment of research activities and clinical workflow processes are some of the factors identified by participants that support IHC clinics' ability to conduct outcomes research. Conclusions Assessing and enhancing the broader

  10. Beyond FEV1 in COPD: a review of patient-reported outcomes and their measurement

    Science.gov (United States)

    Jones, Paul; Miravitlles, Marc; van der Molen, Thys; Kulich, Karoly

    2012-01-01

    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 instruments do not necessarily have better discriminative or evaluative properties than older instruments. The development of new PRO tools, however, is crucial, not only to ensure that key COPD concepts are being reliably measured but also that the relevant treatment effects are being captured in clinical trials. In turn, this will help us to understand better the patient’s experience of the disease. PMID:23093901

  11. Results and outcome reporting In ClinicalTrials.gov, what makes it happen?

    Directory of Open Access Journals (Sweden)

    Olga Kirillova

    Full Text Available BACKGROUND: At the end of the past century there were multiple concerns regarding lack of transparency in the conduct of clinical trials as well as some ethical and scientific issues affecting the trials' design and reporting. In 2000 ClinicalTrials.gov data repository was developed and deployed to serve public and scientific communities with valid data on clinical trials. Later in order to increase deposited data completeness and transparency of medical research a set of restrains had been imposed making the results deposition compulsory for multiple cases. METHODS: We investigated efficiency of the results deposition and outcome reporting as well as what factors make positive impact on providing information of interest and what makes it more difficult, whether efficiency depends on what kind of institution was a trial sponsor. Data from the ClinicalTrials.gov repository has been classified based on what kind of institution a trial sponsor was. The odds ratio was calculated for results and outcome reporting by different sponsors' class. RESULTS: As of 01/01/2012 118,602 clinical trials data deposits were made to the depository. They came from 9068 different sources. 35344 (29.8% of them are assigned as FDA regulated and 25151 (21.2% as Section 801 controlled substances. Despite multiple regulatory requirements, only about 35% of trials had clinical study results deposited, the maximum 55.56% of trials with the results, was observed for trials completed in 2008. CONCLUSIONS: The most positive impact on depositing results, the imposed restrains made for hospitals and clinics. Health care companies showed much higher efficiency than other investigated classes both in higher fraction of trials with results and in providing at least one outcome for their trials. They also more often than others deposit results when it is not strictly required, particularly, in the case of non-interventional studies.

  12. Comparison of statistical and clinical predictions of functional outcome after ischemic stroke.

    Directory of Open Access Journals (Sweden)

    Douglas D Thompson

    Full Text Available To determine whether the predictions of functional outcome after ischemic stroke made at the bedside using a doctor's clinical experience were more or less accurate than the predictions made by clinical prediction models (CPMs.A prospective cohort study of nine hundred and thirty one ischemic stroke patients recruited consecutively at the outpatient, inpatient and emergency departments of the Western General Hospital, Edinburgh between 2002 and 2005. Doctors made informal predictions of six month functional outcome on the Oxford Handicap Scale (OHS. Patients were followed up at six months with a validated postal questionnaire. For each patient we calculated the absolute predicted risk of death or dependence (OHS≥3 using five previously described CPMs. The specificity of a doctor's informal predictions of OHS≥3 at six months was good 0.96 (95% CI: 0.94 to 0.97 and similar to CPMs (range 0.94 to 0.96; however the sensitivity of both informal clinical predictions 0.44 (95% CI: 0.39 to 0.49 and clinical prediction models (range 0.38 to 0.45 was poor. The prediction of the level of disability after stroke was similar for informal clinical predictions (ordinal c-statistic 0.74 with 95% CI 0.72 to 0.76 and CPMs (range 0.69 to 0.75. No patient or clinician characteristic affected the accuracy of informal predictions, though predictions were more accurate in outpatients.CPMs are at least as good as informal clinical predictions in discriminating between good and bad functional outcome after ischemic stroke. The place of these models in clinical practice has yet to be determined.

  13. New perspectives in long-term outcomes in clinical trials of pulmonary arterial hypertension

    Directory of Open Access Journals (Sweden)

    Ioana R. Preston

    2013-12-01

    Full Text Available The past two decades have seen significant improvements in the management of patients with pulmonary arterial hypertension (PAH. Although outcome has improved, long-term prognosis remains unsatisfactory. The development of new treatment options is clearly important. Equally important is testing new agents in trials designed to provide robust evidence for sustained clinical benefits enabling clinicians to determine the optimal treatment strategy for individual patients. End-points such as the change in 6-min walk distance (6MWD have been pivotal in the registration trials of currently available PAH-specific therapies. However, as current clinical trials enrol patients with milder disease, many already on background therapy, there is growing evidence that change from baseline in 6MWD is a weak surrogate of outcome in PAH. In addition, while short-term trials allowed for the rapid approval of PAH therapies in the past, there is increasing recognition that clinical trials for new agents must provide evidence of long-term benefits. Clinical trials need to evolve to provide the long-term, clinically relevant data required to appropriately assess new therapies. Event-driven long-term morbidity and mortality trials are currently underway, and will provide robust data on the frequency and timing of events, and are likely to reflect the future of clinical trial design in PAH.

  14. Experimental evaluation of nonclassical correlations between measurement outcomes and target observable in a quantum measurement

    Science.gov (United States)

    Iinuma, Masataka; Suzuki, Yutaro; Nii, Taiki; Kinoshita, Ryuji; Hofmann, Holger F.

    2016-03-01

    In general, it is difficult to evaluate measurement errors when the initial and final conditions of the measurement make it impossible to identify the correct value of the target observable. Ozawa proposed a solution based on the operator algebra of observables which has recently been used in experiments investigating the error-disturbance trade-off of quantum measurements. Importantly, this solution makes surprisingly detailed statements about the relations between measurement outcomes and the unknown target observable. In the present paper, we investigate this relation by performing a sequence of two measurements on the polarization of a photon, so that the first measurement commutes with the target observable and the second measurement is sensitive to a complementary observable. While the initial measurement can be evaluated using classical statistics, the second measurement introduces the effects of quantum correlations between the noncommuting physical properties. By varying the resolution of the initial measurement, we can change the relative contribution of the nonclassical correlations and identify their role in the evaluation of the quantum measurement. It is shown that the most striking deviation from classical expectations is obtained at the transition between weak and strong measurements, where the competition between different statistical effects results in measurement values well outside the range of possible eigenvalues.

  15. Cyclophilin B Expression Is Associated with In Vitro Radioresistance and Clinical Outcome after Radiotherapy

    Directory of Open Access Journals (Sweden)

    Paul D. Williams

    2011-12-01

    Full Text Available The tools for predicting clinical outcome after radiotherapy are not yet optimal. To improve on this, we applied the COXEN informatics approach to in vitro radiation sensitivity data of transcriptionally profiled human cells and gene expression data from untreated head and neck squamous cell carcinoma (HNSCC and bladder tumors to generate a multigene predictive model that is independent of histologic findings and reports on tumor radiosensitivity. The predictive ability of this 41-gene model was evaluated in patients with HNSCC and was found to stratify clinical outcome after radiotherapy. In contrast, this model was not useful in stratifying similar patients not treated with radiation. This led us to hypothesize that expression of some of the 41 genes contributes to tumor radioresistance and clinical recurrence. Hence, we evaluated the expression the 41 genes as a function of in vitro radioresistance in the NCI-60 cancer cell line panel and found cyclophilin B (PPIB, a peptidylprolyl isomerase and target of cyclosporine A (CsA, had the strongest direct correlation. Functional inhibition of PPIB by small interfering RNA depletion or CsA treatment leads to radiosensitization in cancer cells and reduced cellular DNA repair. Immunohistochemical evaluation of PPIB expression in patients with HNSCC was found to be associated with outcome after radiotherapy. This work demonstrates that a novel 41-gene expression model of radiation sensitivity developed in bladder cancer cell lines and human skin fibroblasts predicts clinical outcome after radiotherapy in head and neck cancer patients and identifies PPIB as a potential target for clinical radiosensitization.

  16. Clinical outcomes of transcatheter aortic valve implantation: from learning curve to proficiency

    Science.gov (United States)

    Lunardi, Mattia; Pesarini, Gabriele; Zivelonghi, Carlo; Piccoli, Anna; Geremia, Giulia; Ariotti, Sara; Rossi, Andrea; Gambaro, Alessia; Gottin, Leonardo; Faggian, Giuseppe; Vassanelli, Corrado; Ribichini, Flavio

    2016-01-01

    Objective The use of transcatheter aortic valve implantation (TAVI) is growing rapidly in countries with a predominantly elderly population, posing a huge challenge to healthcare systems worldwide. The increment of human and economic resource consumption imposes a careful monitoring of clinical outcomes and cost-benefit balance, and this article is aimed at analysing clinical outcomes related to the TAVI learning curve. Methods Outcomes of 177 consecutive transfemoral TAVI procedures performed in 5 years by a single team were analysed by the Cumulative Sum of failures method (CUSUM) according to the clinical events comprised in the Valve Academic Research Consortium (VARC-2) safety end point and the VARC-2 definition of device success. Margins for events acceptance were extrapolated from landmark trials that tested both balloon or self-expandable percutaneous valves. Results 30-day and 1-year survival rates were 97.2% and 89.9%, respectively. Achievement of the primary end point (number of cases needed to provide the acceptable margin of the composite end point of any death, stroke, myocardial infarction, life-threatening bleeding, major vascular complications, stage 2–3 acute kidney injury and valve-related dysfunction requiring a repeat procedure) required the performance of 54 cases, while the learning curve to achieve ‘device success’ identified 32 cases to reach the expected proficiency. In this experience, the baseline clinical risk as assessed by the Society of Thoracic Surgeons (STS) score determined the long-term survival rather than the adverse events related to the learning curve. Conclusions A relatively large number of cases are required to achieve clinical outcomes comparable to those reported in high-volume centres and controlled trials. According to our national workload standards, this represents more than 2 years of continuous activity.

  17. Achievements in mental health outcome measurement in Australia: Reflections on progress made by the Australian Mental Health Outcomes and Classification Network (AMHOCN

    Directory of Open Access Journals (Sweden)

    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.

  18. Beyond FEV1 in COPD: a review of patient-reported outcomes and their measurement

    Directory of Open Access Journals (Sweden)

    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. Predicting clinical outcome from reward circuitry function and white matter structure in behaviorally and emotionally dysregulated youth.

    Science.gov (United States)

    Bertocci, M A; Bebko, G; Versace, A; Fournier, J C; Iyengar, S; Olino, T; Bonar, L; Almeida, J R C; Perlman, S B; Schirda, C; Travis, M J; Gill, M K; Diwadkar, V A; Forbes, E E; Sunshine, J L; Holland, S K; Kowatch, R A; Birmaher, B; Axelson, D; Horwitz, S M; Frazier, T W; Arnold, L E; Fristad, M A; Youngstrom, E A; Findling, R L; Phillips, M L

    2016-09-01

    Behavioral and emotional dysregulation in childhood may be understood as prodromal to adult psychopathology. Additionally, there is a critical need to identify biomarkers reflecting underlying neuropathological processes that predict clinical/behavioral outcomes in youth. We aimed to identify such biomarkers in youth with behavioral and emotional dysregulation in the Longitudinal Assessment of Manic Symptoms (LAMS) study. We examined neuroimaging measures of function and white matter in the whole brain using 80 youth aged 14.0 (s.d.=2.0) from three clinical sites. Linear regression using the LASSO (Least Absolute Shrinkage and Selection Operator) method for variable selection was used to predict severity of future behavioral and emotional dysregulation measured by the Parent General Behavior Inventory-10 Item Mania Scale (PGBI-10M)) at a mean of 14.2 months follow-up after neuroimaging assessment. Neuroimaging measures, together with near-scan PGBI-10M, a score of manic behaviors, depressive behaviors and sex, explained 28% of the variance in follow-up PGBI-10M. Neuroimaging measures alone, after accounting for other identified predictors, explained ~1/3 of the explained variance, in follow-up PGBI-10M. Specifically, greater bilateral cingulum length predicted lower PGBI-10M at follow-up. Greater functional connectivity in parietal-subcortical reward circuitry predicted greater PGBI-10M at follow-up. For the first time, data suggest that multimodal neuroimaging measures of underlying neuropathologic processes account for over a third of the explained variance in clinical outcome in a large sample of behaviorally and emotionally dysregulated youth. This may be an important first step toward identifying neurobiological measures with the potential to act as novel targets for early detection and future therapeutic interventions. PMID:26903272

  20. Predicting clinical outcome from reward circuitry function and white matter structure in behaviorally and emotionally dysregulated youth

    Science.gov (United States)

    Bertocci, Michele A.; Bebko, Genna; Versace, Amelia; Fournier, Jay C.; Iyengar, Satish; Olino, Thomas; Bonar, Lisa; Almeida, Jorge R. C.; Perlman, Susan B.; Schirda, Claudiu; Travis, Michael J.; Gill, Mary Kay; Diwadkar, Vaibhav A.; Forbes, Erika E.; Sunshine, Jeffrey L.; Holland, Scott K; Kowatch, Robert A.; Birmaher, Boris; Axelson, David; Horwitz, Sarah M.; Frazier, Thomas W.; Arnold, L. Eugene; Fristad, Mary. A; Youngstrom, Eric A.; Findling, Robert L.; Phillips, Mary L.

    2015-01-01

    Behavioral and emotional dysregulation in childhood may be understood as prodromal to adult psychopathology. Additionally, there is a critical need to identify biomarkers reflecting underlying neuropathological processes that predict clinical/behavioral outcomes in youth. We aimed to identify such biomarkers in youth with behavioral and emotional dysregulation in the Longitudinal Assessment of Manic Symptoms (LAMS) study. We examined neuroimaging measures of function and white matter in the whole brain using 80 youth aged 14.0(sd=2.0) from 3 clinical sites. Linear regression using the LASSO method for variable selection was used to predict severity of future behavioral and emotional dysregulation [measured by the Parent General Behavior Inventory-10 Item Mania Scale (PGBI-10M)] at a mean of 14.2 months follow-up after neuroimaging assessment. Neuroimaging measures, together with near-scan PGBI-10M, a score of manic behaviors, depressive behaviors, and sex, explained 28% of the variance in follow-up PGBI-10M. Neuroimaging measures alone, after accounting for other identified predictors, explained approximately one-third of the explained variance, in follow-up PGBI-10M. Specifically, greater bilateral cingulum length predicted lower PGBI-10M at follow-up. Greater functional connectivity in parietal-subcortical reward circuitry predicted greater PGBI-10M at follow-up. For the first time, data suggest that multimodal neuroimaging measures of underlying neuropathologic processes account for over a third of the explained variance in clinical outcome in a large sample of behaviorally and emotionally dysregulated youth. This may be an important first step toward identifying neurobiological measures with the potential to act as novel targets for early detection and future therapeutic interventions. PMID:26903272

  1. Clinical Decision Making and Outcome in Routine Care for People with Severe Mental Illness (CEDAR: Study protocol

    Directory of Open Access Journals (Sweden)

    Nemes Zoltan

    2010-11-01

    Full Text Available Abstract Background A considerable amount of research has been conducted on clinical decision making (CDM in short-term physical conditions. However, there is a lack of knowledge on CDM and its outcome in long-term illnesses, especially in care for people with severe mental illness. Methods/Design The study entitled "Clinical decision making and outcome in routine care for people with severe mental illness" (CEDAR is carried out in six European countries (Denmark, Germany, Hungary, Italy, Switzerland and UK. First, CEDAR establishes a methodology to assess CDM in people with severe mental illness. Specific instruments are developed (and psychometric properties established to measure CDM style, key elements of CDM in routine care, as well as CDM involvement and satisfaction from patient and therapist perspectives. Second, these instruments are being put to use in a multi-national prospective observational study (bimonthly assessments during a one-year observation period; N = 560. This study investigates the immediate, short- and long-term effect of CDM on crucial dimensions of clinical outcome (symptom level, quality of life, needs by taking into account significant variables moderating the relationship between CDM and outcome. Discussion The results of this study will make possible to delineate quality indicators of CDM, as well as to specify prime areas for further improvement. Ingredients of best practice in CDM in the routine care for people with severe mental illness will be extracted and recommendations formulated. With its explicit focus on the patient role in CDM, CEDAR will also contribute to strengthening the service user perspective. This project will substantially add to improving the practice of CDM in mental health care across Europe. Trial register ISRCTN75841675.

  2. Symptomatic and quality-of-life outcomes after treatment for clinically localised prostate cancer: a systematic review.

    Science.gov (United States)

    Whiting, Penny F; Moore, Theresa H M; Jameson, Catherine M; Davies, Philippa; Rowlands, Mari-Anne; Burke, Margaret; Beynon, Rebecca; Savovic, Jelena; Donovan, Jenny L

    2016-08-01

    To conduct a systematic review of the risks of short-term outcomes after major treatments for clinically localised prostate cancer. MEDLINE, EMBASE and the Cochrane Library were searched from 2004 to January 2013. Study arms that included ≥100 men with localised prostate cancer in receipt of surgery, radiotherapy or active surveillance and reported symptomatic and quality-of-life (QoL) data from 6 to 60 months after treatment were eligible. Data were extracted by one reviewer and checked by another. In all, 64 studies (80 treatment cohorts) were included. Most were single treatment cohorts from the USA or Europe. Radiotherapy was the most common treatment (40 cohorts, including 31 brachytherapy cohorts) followed by prostatectomy (39 cohorts), with only one active surveillance cohort. Most frequently measured symptoms were urinary, followed by sexual, and bowel; QoL was assessed in only 17 cohorts. Most studies used validated measures, although poor data reporting and differences between studies meant that it was not possible to pool data. Data on the precise impact of short-term symptomatic and QoL outcomes after treatment for localised prostate cancer are of insufficient quality for clear guidance to men about the risks to these aspects of their lives. It is important that future studies focus on collecting core outcomes through validated measures and comply with reporting guidelines, so that clear and accurate information can be derived for men considering screening or treatment for prostate cancer. PMID:27087414

  3. Clinical and biomechanical outcome of minimal invasive and open repair of the Achilles tendon

    Directory of Open Access Journals (Sweden)

    Chan Alexander

    2011-12-01

    Full Text Available Abstract Introduction With evolutions in surgical techniques, minimally invasive surgical (MIS repair with Achillon applicator has been introduced. However, there is still a lack of literature to investigate into the clinical merits of MIS over open surgery. This study aims to investigate the correlation between clinical outcome, gait analysis and biomechanical properties comparing both surgical methods. Materials and methods A single centre retrospective review on all the consecutive operated patients between January 2004 and December 2008 was performed. Twenty-six patients (19 male and 7 female; age 40.4 ± 9.2 years had experienced a complete Achilles tendon rupture with operative repair. Nineteen of the patients, 10 MIS versus 9 open repairs (13 men with a mean age of 40.54 ± 10.43 (range 23-62 yrs and 6 women with a mean age of 45.33 ± 7.71 (range 35-57 yrs were further invited to attend a thorough clinical assessment using Holz's scale and biomechanical evaluation at a mean of 25.3 months after operation. This study utilized the Cybex II isokinetic dynamometer to assess the isokinetic peak force of plantar-flexion and dorsiflexion of both ankles. The patients were also invited to return to our Gait Laboratory for analysis. The eight-infrared camera motion capture system (VICON, UK was utilized for the acquisition of kinematic variables. Their anthropometric data was measured according to the Davis and coworkers' standard. Results The mean operative time and length of hospital stay were shorter in the MIS group. The operative time was 54.55 ± 15.15 minutes versus 68.80 ± 18.23 minutes of the MIS group and Open group respectively (p = 0.045, whereas length of stay was 3.36 ± 1.21 days versus 6.40 ± 3.70 days respectively (p = 0.039. There is statistically significant decrease (p = 0.005 in incision length in MIS group than the open surgery group, 3.23 ± 1.10 cm versus 9.64 ± 2.55 cm respectively. Both groups attained similar Holz

  4. Common minor histocompatibility antigen discovery based upon patient clinical outcomes and genomic data.

    Directory of Open Access Journals (Sweden)

    Paul M Armistead

    Full Text Available BACKGROUND: Minor histocompatibility antigens (mHA mediate much of the graft vs. leukemia (GvL effect and graft vs. host disease (GvHD in patients who undergo allogeneic stem cell transplantation (SCT. Therapeutic decision making and treatments based upon mHAs will require the evaluation of multiple candidate mHAs and the selection of those with the potential to have the greatest impact on clinical outcomes. We hypothesized that common, immunodominant mHAs, which are presented by HLA-A, B, and C molecules, can mediate clinically significant GvL and/or GvHD, and that these mHAs can be identified through association of genomic data with clinical outcomes. METHODOLOGY/PRINCIPAL FINDINGS: Because most mHAs result from donor/recipient cSNP disparities, we genotyped 57 myeloid leukemia patients and their donors at 13,917 cSNPs. We correlated the frequency of genetically predicted mHA disparities with clinical evidence of an immune response and then computationally screened all peptides mapping to the highly associated cSNPs for their ability to bind to HLA molecules. As proof-of-concept, we analyzed one predicted antigen, T4A, whose mHA mismatch trended towards improved overall and disease free survival in our cohort. T4A mHA mismatches occurred at the maximum theoretical frequency for any given SCT. T4A-specific CD8+ T lymphocytes (CTLs were detected in 3 of 4 evaluable post-transplant patients predicted to have a T4A mismatch. CONCLUSIONS/SIGNIFICANCE: Our method is the first to combine clinical outcomes data with genomics and bioinformatics methods to predict and confirm a mHA. Refinement of this method should enable the discovery of clinically relevant mHAs in the majority of transplant patients and possibly lead to novel immunotherapeutics.

  5. A multilevel investigation of inequalities in clinical and psychosocial outcomes for women after breast cancer

    Directory of Open Access Journals (Sweden)

    Aitken Joanne F

    2011-09-01

    Full Text Available Abstract Background In Australia, breast cancer is the most common cancer affecting Australian women. Inequalities in clinical and psychosocial outcomes have existed for some time, affecting particularly women from rural areas and from areas of disadvantage. We have a limited understanding of how individual and area-level factors are related to each other, and their associations with survival and other clinical and psychosocial outcomes. Methods/Design This study will examine associations between breast cancer recurrence, survival and psychosocial outcomes (e.g. distress, unmet supportive care needs, quality of life. The study will use an innovative multilevel approach using area-level factors simultaneously with detailed individual-level factors to assess the relative importance of remoteness, socioeconomic and demographic factors, diagnostic and treatment pathways and processes, and supportive care utilization to clinical and psychosocial outcomes. The study will use telephone and self-administered questionnaires to collect individual-level data from approximately 3, 300 women ascertained from the Queensland Cancer Registry diagnosed with invasive breast cancer residing in 478 Statistical Local Areas Queensland in 2011 and 2012. Area-level data will be sourced from the Australian Bureau of Statistics census data. Geo-coding and spatial technology will be used to calculate road travel distances from patients' residence to diagnostic and treatment centres. Data analysis will include a combination of standard empirical procedures and multilevel modelling. Discussion The study will address the critical question of: what are the individual- or area-level factors associated with inequalities in outcomes from breast cancer? The findings will provide health care providers and policy makers with targeted information to improve the management of women with breast cancer, and inform the development of strategies to improve psychosocial care for women

  6. Clinical outcome in 20 cases of lingual hemangiosarcoma in dogs: 1996-2011.

    Science.gov (United States)

    Burton, J H; Powers, B E; Biller, B J

    2014-09-01

    With the exception of solar-induced dermal hemangiosarcoma (HSA), the biologic behaviour of canine HSA is characterised by rapid tumour growth, a high metastatic rate and short survival times. Outcome of dogs with HSA of the tongue has not been previously reported. The purpose of this study was to assess outcome and prognostic factors in dogs with lingual HSA. Clinical data was collected retrospectively and histopathology was reviewed for 20 dogs. Median progression free survival was 524 days and the median overall survival time was 553 days. All dogs had low or intermediate grade tumours; most tumours were small and located on the ventral surface of the tongue. Prognostic factors significantly associated with increased survival included small tumour size and absence of clinical signs of an oral mass at the time of diagnosis. Dogs with HSA confined to the tongue may have a better prognosis compared with HSA in other organs. PMID:22905712

  7. Skin Disease in the Uninsured: Diagnoses, Management Decisions, and Referral Outcomes of an Urban Free Clinic.

    Science.gov (United States)

    Rosenbaum, Brooke E; Freitas, Derek; Nosal, Sarah C; Meydani, Ahou

    2016-01-01

    An understanding of the burden of skin disease in the uninsured population is needed to address the unique barriers they face to access dermatologic care. We conducted a retrospective chart review of patients seen for skin conditions over three years at the New York City (NYC) Free Clinic, a weekly primary care clinic operated by the NYU School of Medicine and the Institute for Family Health. Main outcomes of this study were descriptive analyses of demographic characteristics, diagnoses, management strategies, and referral outcomes, as well as key factors influencing referral to a dermatologist and referral attendance. Diagnosis was a significant predictor of referral (ptravel distance had no significant association with non-attendance. While demand for dermatologic care by uninsured patients in NYC is high, referral non-attendance remains a substantial barrier to care. PMID:27180711

  8. The influence of job characteristics on job outcomes of pharmacists in hospital, clinic, and community pharmacies.

    Science.gov (United States)

    Lin, Blossom Yen-Ju; Yeh, Ying-Chen; Lin, Wen-Hung

    2007-06-01

    This study examines the relationship between job characteristics and job outcomes of pharmacists in hospital, clinic, and community pharmacies in Taiwan. The structured questionnaires covered the items of job characteristics, job outcomes, and demographics of pharmacists, and were distributed between Feb 2004 and April 2004. Two hundred and ninety-eight pharmacists responded. Data were analyzed descriptively, and univariate analyses, factor analysis, and multiple regression analyses were used. It found the more enriched the job, the greater the job satisfaction and less intention to leave. And community pharmacists reported greater job enrichment and job satisfaction and less intention to leave than did hospital and clinic pharmacists. It suggests pharmacy managers could recognize the needs of pharmacists to redesign and enrich their work arrangements. PMID:17622026

  9. Low-molecular-weight cyclin E: the missing link between biology and clinical outcome

    International Nuclear Information System (INIS)

    Cyclin E, a key mediator of transition during the G1/S cellular division phase, is deregulated in a wide variety of human cancers. Our group recently reported that overexpression and generation of low-molecular-weight (LMW) isoforms of cyclin E were associated with poor clinical outcome among breast cancer patients. However, the link between LMW cyclin E biology in mediating a tumorigenic phenotype and clinical outcome is unknown. To address this gap in knowledge, we assessed the role of LMW isoforms in breast cancer cells; we found that these forms of cyclin E induced genomic instability and resistance to p21, p27, and antiestrogens in breast cancer. These findings suggest that high levels of LMW isoforms of cyclin E not only can predict failure to endocrine therapy but also are true prognostic indicators because of their influence on cell proliferation and genetic instability

  10. Clinical Characteristics and Outcome of Cardiovascular Implantable Electronic Device Infections in Turkey.

    Science.gov (United States)

    Aydin, Mesut; Yildiz, Abdulkadir; Kaya, Zeynettin; Kaya, Zekeriya; Basarir, Ahmet Ozgur; Cakmak, Nazmiye; Donmez, Ibrahim; Morrad, Baktash; Avci, Ahmet; Demir, Kenan; Cagliyan, Emre Caglar; Yuksel, Murat; Elbey, Mehmet Ali; Kayan, Fethullah; Ozaydogdu, Necdet; Islamoglu, Yahya; Cayli, Murat; Alan, Said; Ulgen, Mehmet Siddik; Ozhan, Hakan

    2016-07-01

    Infection is one of the most devastating outcomes of cardiovascular implantable electronic device (CIED) implantation and is related to significant morbidity and mortality. In our country, there is no evaluation about CIED infection. Therefore, our aim was to investigate clinical characteristics and outcome of patients who had infection related to CIED implantation or replacement. The study included 144 consecutive patients with CIED infection treated at 11 major hospitals in Turkey from 2005 to 2014 retrospectively. We analyzed the medical files of all patients hospitalized with the diagnosis of CIED infection. Inclusion criteria were definite infection related to CIED implantation, replacement, or revision. Generator pocket infection, with or without bacteremia, was the most common clinical presentation, followed by CIED-related endocarditis. Coagulase-negative staphylococci and Staphylococcus aureus were the leading causative agents of CIED infection. Multivariate analysis showed that infective endocarditis and ejection fraction were the strongest predictors of in-hospital mortality. PMID:25589093

  11. Improvement in clinical outcomes after dry needling in a patient with occipital neuralgia.

    Science.gov (United States)

    Bond, Bryan M; Kinslow, Christopher

    2015-06-01

    The primary purpose of this case report is to outline the diagnosis, intervention and clinical outcome of a patient presenting with occipital neuralgia. Upon initial presentation, the patient described a four-year history of stabbing neck pain and headaches. After providing informed consent, the patient underwent a total of four dry needling (DN) sessions over a two-week duration. During each of the treatment sessions, needles were inserted into the trapezii and suboccipital muscles. Post-intervention, the patient reported a 32-point change in her neck disability index score along with a 28-point change in her headache disability index score. Thus, it appears that subsequent four sessions of DN over two weeks, our patient experienced meaningful improvement in her neck pain and headaches. To the best of our knowledge, this is the first case report describing DN to successfully improve clinical outcomes in a patient diagnosed with occipital neuralgia. PMID:26136602

  12. Realization of continuous-outcome measurements on finite dimensional quantum systems

    OpenAIRE

    Chiribella, G.; D'Ariano, G. M.; Schlingemann, D. M.

    2007-01-01

    This note contains the complete mathematical proof of the main Theorem of the paper "How continuous measurements in finite dimension are actually discrete" (quant-ph/0702068), thus showing that in finite dimension any measurement with continuous set of outcomes can be simply realized by randomizing some classical parameter and conditionally performing a measurement with finite outcomes.

  13. Magnetic resonance imaging findings of postresuscitation encephalopathy. Sequential change and correlation with clinical outcome

    International Nuclear Information System (INIS)

    The purpose of this study was to describe the findings of sequential magnetic resonance imaging (MRI) in postresuscitation encephalopathy. Although its outcome is known to be overwhelming, but its acute findings by variable imaging methods are subtle and show only limited values. The correlation of the findings of MRI with clinical outcome were also analyzed. Twelve patients with global cerebral anoxia who underwent MRI with conventional and diffusion-weighted imaging were enrolled in this study. Compared with normal MRI images, abnormal signal regions were checked and described in cortex, basal ganglia and white matter. Also medical records were carefully reviewed to study the cause, the time necessary for resuscitation and long term clinical outcome. The earliest finding was obtained by diffusion-weighted image less than 24 hours (acute period) in bilateral cerebral cortex as bright high signal intensity regions. Similar abnormality of bright high signal area in FLAIR and T2 was followed according to the time elapsed in early subacute period (1-13 days). Succeedingly, white matter was involved and laminar necrosis in cortical area was observed in late subacute period (14-20 days). Finally, diffuse brain atrophy and obtundation of gray-white matter junction were seen in chronic stage (after 21 days). These MR findings were coincided well with histopathological findings reported in literatures. The poor outcome was closely and significantly correlated with abnormality in MR images. MRI was a useful diagnostic modality to diagnose the whole brain ischemic encephalopathy and to predict the prognosis. (author)

  14. Clinical management and survival outcomes of gliosarcomas in the era of multimodality therapy.

    Science.gov (United States)

    Damodaran, Omprakash; van Heerden, Jolandi; Nowak, Anna K; Bynevelt, Michael; McDonald, Kerrie; Marsh, Julie; Lee, Gabriel

    2014-03-01

    Gliosarcoma (GSM) is a rare primary malignant brain tumour accounting for less than 0.5% of all intracranial tumours. It has a biphasic histological composition, demonstrating both gliomatous and sarcomatous elements. In clinical practice GSM are generally managed similarly to glioblastoma multiforme (GBM). However, unique features including its clinical propensity for extra-cranial metastasis, distinct radiological features and possible worse prognosis than GBM suggest that GSM may be a distinct clinico-pathological entity. Hence we reviewed patterns of care and outcomes for a series of Australian patients diagnosed with GSM in the era of combined chemo-radiotherapy. Patients were identified by searching the Australian Genomics and Clinical Outcomes of Glioma (AGOG) database and the Western Australian Interhospital Neurosurgical database. Nineteen patients with GSM were identified. Of these, 15 patients were diagnosed with primary GSM and four patients developed secondary GSM after radiation therapy for primary GBM. For comparative purposes, 408 primary GBM patients were identified from the AGOG database during the same study period. The overall median survival for all primary GSM patients was 9.7 months. In comparison the overall median survival for GBM patients recruited to the AGOG database over the same period was 12.2 months. The median survival for secondary GSM patients from the time of diagnosis was 5 months. Primary and secondary GSM pose a great clinical challenge due to their rarity. Our study adds further evidence to support GSM as a unique clinical entity with a likely worse prognosis than GBM. PMID:24332268

  15. Acute pyelonephritis: role of enhanced CT scan in the prediction of clinical outcome

    International Nuclear Information System (INIS)

    To correlate the CT findings of acute pyelonephritis with its outcome and with clinical data. Thirty five contrast enhanced CT scans in patients diagnosed as suffering from acute pyelonephritis were retrospectively analyzed. Findings based on the morphology of perfusion defect in the renal parenchyma were classified as normal, focal wedge, multifocal wedge, focal mass, or mixed form composed of wedge and mass. These findings were correlated with clinical data such as degree of fever, leukocytosis, the period after antibiotic treatment during which fever was reduced, and the presence of pyuria in each group Analysis was then performed. Perfusion defects were seen in 23 of 35 cases, and their morphology was classified as follow; focal wedge (n=2), multifocal wedge (n=8), focal mass (n=4), and mixed form (n=9). Twelve cases (34.3%) showed no perfusion defect. The duration of fever was significantly prolonged in patients with focal mass form (p < .05). There was no significant correlation between the morphology of perfusion defect, bilaterality, and other clinical factors. The present study shows that the clinical course of the focal mass form of perfusion defect, as seen on CT, is different from that of other types. CT could be effective in predicting clinical progress and the outcome of treatment in cases of acute pyelonephritis

  16. Acute pyelonephritis: role of enhanced CT scan in the prediction of clinical outcome

    Energy Technology Data Exchange (ETDEWEB)

    Jo, Byung June; Kim, Ki Whang; Yu, Jeong Sik; Kim, Jai Keun; Yoon, Sang Wook; Ha, Sung Kyu; Park, Chong Hoon [Yonsei Univ. College of Medicine, Seoul (Korea, Republic of)

    1997-04-01

    To correlate the CT findings of acute pyelonephritis with its outcome and with clinical data. Thirty five contrast enhanced CT scans in patients diagnosed as suffering from acute pyelonephritis were retrospectively analyzed. Findings based on the morphology of perfusion defect in the renal parenchyma were classified as normal, focal wedge, multifocal wedge, focal mass, or mixed form composed of wedge and mass. These findings were correlated with clinical data such as degree of fever, leukocytosis, the period after antibiotic treatment during which fever was reduced, and the presence of pyuria in each group Analysis was then performed. Perfusion defects were seen in 23 of 35 cases, and their morphology was classified as follow; focal wedge (n=2), multifocal wedge (n=8), focal mass (n=4), and mixed form (n=9). Twelve cases (34.3%) showed no perfusion defect. The duration of fever was significantly prolonged in patients with focal mass form (p < .05). There was no significant correlation between the morphology of perfusion defect, bilaterality, and other clinical factors. The present study shows that the clinical course of the focal mass form of perfusion defect, as seen on CT, is different from that of other types. CT could be effective in predicting clinical progress and the outcome of treatment in cases of acute pyelonephritis.

  17. Healthcare Utilization and Clinical Outcomes after Catheter Ablation of Atrial Flutter

    OpenAIRE

    Dewland, Thomas A.; Glidden, David V.; Marcus, Gregory M

    2014-01-01

    Atrial flutter ablation is associated with a high rate of acute procedural success and symptom improvement. The relationship between ablation and other clinical outcomes has been limited to small studies primarily conducted at academic centers. We sought to determine if catheter ablation of atrial flutter is associated with reductions in healthcare utilization, atrial fibrillation, or stroke in a large, real world population. California Healthcare Cost and Utilization Project databases were u...

  18. GWAS-identified colorectal cancer susceptibility loci associated with clinical outcomes

    OpenAIRE

    Dai, Jingyao; Gu, Jian; Huang, Maosheng; Eng, Cathy; Kopetz, E. Scott; Ellis, Lee M.; Hawk, Ernest; Wu, Xifeng

    2012-01-01

    Recent genome-wide association studies (GWAS) have identified several common susceptibility loci associated with the risk of colorectal cancer (CRC). However, whether these loci affect clinical outcomes of CRC is not clear. In this study, we genotyped 26 single nucleotide polymorphisms (SNPs) in 10 GWAS-identified CRC susceptibility regions and evaluated their associations with survival and recurrence in 285 stage II and III patients receiving fluorouracil-based adjuvant chemotherapy. Only on...

  19. Clinical Outcomes of Heart-Lung Transplantation: Review of 10 Single-Center Consecutive Patients

    OpenAIRE

    Yun, Jae Kwang; Choi, Se Hoon; Park, Seung-Il; [...

    2016-01-01

    Background Heart-lung transplantation (HLT) has provided hope to patients with end-stage lung disease and irreversible heart dysfunction. We reviewed the clinical outcomes of 10 patients who underwent heart-lung transplantation at Asan Medical Center. Methods Between July 2010 and August 2014, a total of 11 patients underwent HLT at Asan Medical Center. After excluding one patient who underwent concomitant liver transplantation, 10 patients were enrolled in our study. We reviewed the demograp...

  20. Clinical and functional outcomes of the PCCP study : a multi-center prospective study in Italy

    OpenAIRE

    Antonini, G.; Giancola, R.; D. Berruti; E. Blanchietti; Pecchia, P.; Francione, V.; Greco, P.; T.C. Russo; L. Pietrogrande

    2013-01-01

    The standard surgical management of hip fractures is associated with tissue trauma and bleeding which are added to the fracture injury. The percutaneous compression plate (PCCP) is a minimally invasive device that has been demonstrated in previous studies to reduce postoperative complications and blood loss. This prospective, multi-center, observational study assessed clinical and functional outcomes with PCCP as treatment for trochanteric fractures. Patients with a stable or unstable proxima...

  1. Clinical Outcomes of Double Staining and Additional ILM Peeling during ERM Surgery

    OpenAIRE

    Oh, Ha Na; Lee, Joo Eun; Kim, Hyun Woong; Yun, Il Han

    2013-01-01

    Purpose To assess the clinical outcomes in idiopathic epiretinal membrane (ERM) patients after vitrectomy and ERM removal with or without additional indocyanine green (ICG)-assisted internal limiting membrane (ILM) peeling. Methods The medical records of 43 patients with an idiopathic ERM that underwent vitrectomy and ERM removal between July 2007 and April 2010 were reviewed. The patients were divided into two groups: triamcinolone-assisted simple ERM peeling only (group A, n = 23) and triam...

  2. Clinical Outcome of Magnetic Resonance Imaging-Detected Additional Lesions in Breast Cancer Patients

    OpenAIRE

    Ha, Gi-Won; Yi, Mi Suk; Lee, Byoung Kil; Youn, Hyun Jo; Jung, Sung Hoo

    2011-01-01

    Purpose The aim of this study was to investigate the clinical outcome of additional breast lesions identified with breast magnetic resonance imaging (MRI) in breast cancer patients. Methods A total of 153 patients who underwent breast MRI between July 2006 and March 2008 were retrospectively reviewed. Thirty-three patients (21.6&) were recommended for second-look ultrasound (US) for further characterization of additional lesions detected on breast MRI and these patients constituted our study ...

  3. Clinical and surgical outcomes after lumbar laminectomy: An analysis of 500 patients

    OpenAIRE

    Mohamad Bydon; Mohamed Macki; Abt, Nicholas B.; Sciubba, Daniel M.; Jean-Paul Wolinsky; Timothy F Witham; Gokaslan, Ziya L.; Ali Bydon

    2015-01-01

    Background: The objective of this study is to determine the clinical and surgical outcomes following lumbar laminectomy. Methods: We retrospectively reviewed medical records of neurosurgical patients who underwent first-time, bilateral, 1-3 level laminectomies for degenerative lumbar disease. Patients with discectomy, complete facetectomy, and fusion were excluded. Results: Five hundred patients were followed for an average of 46.79 months. Following lumbar laminectomy, patients exper...

  4. Identifying the barriers to conducting outcomes research in integrative health care clinic settings - a qualitative study

    OpenAIRE

    Findlay-Reece Barbara; Kania Ania; Mulkins Andrea; Verhoef Marja J; Mior Silvano

    2010-01-01

    Abstract Background Integrative health care (IHC) is an interdisciplinary blending of conventional medicine and complementary and alternative medicine (CAM) with the purpose of enhancing patients' health. In 2006, we designed a study to assess outcomes that are relevant to people using such care. However, we faced major challenges in conducting this study and hypothesized that this might be due to the lack of a research climate in these clinics. To investigate these challenges, we initiated a...

  5. Clinical profile and outcomes of atrial fibrillation in elderly patients with acute myocardial infarction

    Institute of Scientific and Technical Information of China (English)

    LI Kang; HUO Yong; DING Yan-sheng

    2008-01-01

    Background Atrial fibrillation (AF) occurs commonly in patients with acute myocardial infarction (MI) and is associated with an increased long-term mortality.This study aimed to investigate the clinical characteristics and outcomes of AF in in-hospital elderly Chinese patients with acute MI.Methods A total of 967 patients with acute MI,aged≥65 years,were categorized on the basis of the absence or presence of AF.Patients with documented AF were classified into two subgroups: the ongoing AF group and the new-onset AF group.We retrospectively evaluated the clinical profile,in-hospital outcomes,and effects of revascularization on the incidence of AF in elderly patients with acute MI.Results AF was documented in 100 (11.53%) patients and the incidence of new-onset AF was 6.51% during hospitalization.History of old MI and cerebrovascular events were more common in patients with AF than in those without AF (P<0.001,P<0.01,respectively).The incidence of AF was higher in patients with non-ST elevated MI (P=0.014),inferior wall MI (P=0.004) and cardiac function of Killip class III or IV (P=0.008).Patients with AF had more complication of pneumonia (P=0.003) and longer hospital stay.Left circumflex coronary artery involvement was more common in patients with AF (compared with patients without AF,P <0.001).Percutaneous coronary intervention or coronary artery bypass grafting significantly decreased the incidence of new-onset AF from 7.97% to 3.82% (P=0.017).AF depended to heart failure,increased the in-hospital mortality.Conclusions AF is common in elderly patients with acute MI and is associated with poorer clinical outcomes.Revascularization reduces the incidence of AF and thus improves the clinical outcomes in these patients.

  6. Influence of early post-burn enteral nutrition on clinical outcomes of patients with extensive burns

    OpenAIRE

    Lu, Guozhong; Huang, Jiren; Yu, Junjie; Zhu, Yugang; Cai, Liangliang; Gu, Zaiqiu; Su, Qinghe

    2011-01-01

    Sepsis commonly occurs in severe post-burn patients, often resulting in death. We aimed to evaluate the influence of early enteral feeding on outcomes in patients with extensive burns, including infection incidence, healing and mortality. We retrospectively reviewed 60 patients with extensive burns, 35 who had received early enteral nutrition and 25 who had received parenteral nutrition. Average healing time, infection incidence and mortality were clinically observed. Hemoglobin and serum alb...

  7. Prime Time: 18-Month Violence Outcomes of a Clinic-Linked Intervention

    OpenAIRE

    Sieving, Renee E.; McMorris, Barbara J.; Secor-Turner, Molly; Garwick, Ann W.; Shlafer, Rebecca; Beckman, Kara J.; Pettingell, Sandra L.; Oliphant, Jennifer A.; Seppelt, Ann M.

    2014-01-01

    Prime Time, a youth development intervention, aims to reduce multiple risk behaviors among adolescent girls seeking clinic services who are at high risk for pregnancy. The purpose of the current study was to examine whether Prime Time involvement produced changes in relational aggression, physical violence and related psychosocial and behavioral outcomes. Qualitative case exemplars illustrated social contexts of intervention participants with differing longitudinal patterns of relational aggr...

  8. Rhino-orbital Mucormycosis: Clinical Findings and Treatment Outcomes of Four Cases

    OpenAIRE

    Şeyda Karadeniz Uğurlu; Sedat Selim; Aylin Kopar; Murat Songu

    2015-01-01

    In this case report, we present the clinical findings and therapeutic outcomes of four rhino-orbital mucormycosis patients. The four patients (1 female, 3 male; age range, 55-77 years) all had diabetes mellitus and two also had chronic renal failure. All patients exhibited proptosis, sinusitis, and dark-colored lesions on the nasopharynx and/or hard palate; three patients had ipsilateral peripheral facial paralysis. Visual acuity was no light perception in the two patients with sever...

  9. A prospective clinical study of feto-maternal outcome in pregnancies with abnormal liquor volume

    OpenAIRE

    Rutwa J. Chavda; Hardev B. Saini

    2014-01-01

    Background: Evaluating feto-maternal outcome in pregnancies with abnormal liquor volume. Methods: 200 pregnant subjects between 20 and 42 weeks of gestation, who were clinically suspected to have an abnormal amniotic fluid volume (oligohydramnios or polyhydramnios) were subjected to ultrasonographic (USG) assessment of amniotic fluid index. The subjects were closely monitored during pregnancy, labour and puerperium. Results: Ultrasonically, abnormal liquor volume was confirmed in 90-93...

  10. Clinical outcome of protein-energy malnourished patients in a Brazilian university hospital

    OpenAIRE

    Pasquini, T.A.S.; H.D. Neder; Araújo-Junqueira, L.; De-Souza, D.A.

    2012-01-01

    Protein-energy malnutrition (PEM) is a treatable disease with high prevalence among hospitalized patients. It can cause significant increases in the duration of hospitalization and costs. PEM is especially important for health systems since malnourished patients present higher morbidity and mortality. The objective of the present study was to assess the evolution of nutritional status (NS) and the effect of malnutrition on clinical outcome of patients at a public university hospital of high c...

  11. Variation in lung function is associated with worse clinical outcomes in cystic fibrosis

    OpenAIRE

    João Paulo Heinzmann-Filho; Leonardo Araujo Pinto; Paulo José Cauduro Marostica; Márcio Vinícius Fagundes Donadio

    2015-01-01

    ABSTRACT OBJECTIVE: To determine whether the variation in lung function over one year is associated with worse clinical outcomes, as well as with a decline in lung function in the following years, in patients with cystic fibrosis (CF). METHODS: This was a retrospective study involving CF patients (4-19 years of age), evaluated over a three-year period. We evaluated demographic characteristics, chronic Pseudomonas aeruginosa infection, antibiotic use, hospitalization, six-minute walk dista...

  12. Variation in lung function is associated with worse clinical outcomes in cystic fibrosis

    OpenAIRE

    Heinzmann-Filho, João Paulo; Pinto, Leonardo Araujo; Marostica, Paulo José Cauduro; Donadio, Márcio Vinícius Fagundes

    2015-01-01

    ABSTRACT OBJECTIVE: To determine whether the variation in lung function over one year is associated with worse clinical outcomes, as well as with a decline in lung function in the following years, in patients with cystic fibrosis (CF). METHODS: This was a retrospective study involving CF patients (4-19 years of age), evaluated over a three-year period. We evaluated demographic characteristics, chronic Pseudomonas aeruginosa infection, antibiotic use, hospitalization, six-minute walk distance ...

  13. Nutritional Care of Gastric Cancer Patients with Clinical Outcomes and Complications: A Review

    OpenAIRE

    Choi, Wook Jin; Kim, Jeongseon

    2016-01-01

    The incidence and mortality of gastric cancer have been steadily decreased over the past few decades. However, gastric cancer is still one of the leading causes of cancer deaths across many regions of the world, particularly in Asian countries. In previous studies, nutrition has been considered one of significant risk factors in gastric cancer patients. Especially, malnourished patients are at greater risk of adverse clinical outcomes (e.g., longer hospital stay) and higher incidence of compl...

  14. Erythrocyte membrane protein destabilization versus clinical outcome in 160 Portuguese Hereditary Spherocytosis patients

    OpenAIRE

    Rocha, Susana; Costa, Elísio; Rocha-Pereira, Petronila; Ferreira, Fátima; Cleto, Esmeralda; Barbot, José; Quintanilha, Alexandre; Belo, Luís; Santos-Silva, Alice

    2010-01-01

    Abstract Hereditary Spherocytosis (HS) is a haemolytic anaemia caused by erythrocyte protein membrane defects ? spectrin, ankyrin, band 3 or protein 4.2 ? that lead to membrane destabilization. Ours aims were to evaluate the prevalence of protein deficiencies and the role of membrane proteins or of membrane linked proteins in membrane disturbance and in HS clinical outcome. We studied 215 Portuguese individuals ? 203 from 71 families plus 12 individual unrelated subjects, and found...

  15. A STUDY ON CLINICAL, LABORATORY PROFILE AND OUTCOME OF DENGUE FEVER

    OpenAIRE

    Vanamali; Venugopal; Yeshwanth; Dilip

    2013-01-01

    ABSTRACT: BACKGROUND AND OBJECTIVES : In recent days there is an alarming increase in the incidence of dengue fever and has emerged as a serious international public health threat with almost half of the world's population at risk for infection . Very few studies have been conducted in this part of our country and hence this study was undertaken to study the clinical picture, la boratory profile and outcome of dengue fever in and around khammam. MATERIAL...

  16. The effects of endometrial injury on intrauterine insemination outcome: A randomized clinical trial

    OpenAIRE

    Afsoon Zarei; Saeed Alborzi; Nasrin Dadras; Ghazal Azadi

    2014-01-01

    Background: Implantation is considered as the rate-limiting step in success of assisted reproduction techniques, and intrauterine insemination cycles. It might be affected by ovarian superovulation and endometrial local scratching. Objective: This study aims to investigate the effect of local endometrial injury on the outcome of IUI cycles. Materials and Methods: In this randomized clinical trial 144 women with unexplained infertility, mild male factor, and mild endometriosis randomly d...

  17. Endophthalmitis caused by Pantoea agglomerans: clinical features, antibiotic sensitivities, and outcomes

    OpenAIRE

    Venincasa VD; Kuriyan AE; Flynn Jr HW; Sridhar J; Miller D

    2015-01-01

    Vincent D Venincasa, Ajay E Kuriyan, Harry W Flynn Jr, Jayanth Sridhar, Darlene Miller Department of Ophthalmology, Bascom Palmer Eye Institute, Miller School of Medicine, University of Miami, Miami, FL, USA Purpose: To report the clinical findings, antibiotic sensitivities, and visual outcomes associated with endophthalmitis caused by Pantoea agglomerans.Methods: A consecutive case series of patients with vitreous culture-positive endophthalmitis caused by P. agglomerans from January 1,...

  18. Endophthalmitis caused by Pantoea agglomerans: clinical features, antibiotic sensitivities, and outcomes

    OpenAIRE

    Kuriyan, Ajay

    2015-01-01

    Vincent D Venincasa, Ajay E Kuriyan, Harry W Flynn Jr, Jayanth Sridhar, Darlene Miller Department of Ophthalmology, Bascom Palmer Eye Institute, Miller School of Medicine, University of Miami, Miami, FL, USA Purpose: To report the clinical findings, antibiotic sensitivities, and visual outcomes associated with endophthalmitis caused by Pantoea agglomerans.Methods: A consecutive case series of patients with vitreous culture-positive endophthalmitis caused by P. agglomerans from Januar...

  19. Clinical outcome and bowel function after surgical treatment in Hirschsprung′s disease

    OpenAIRE

    Maryam Khazdouz; Majid Sezavar; Bahareh Imani; Hossein Akhavan; Alireza Babapour; Gholamreza Khademi

    2015-01-01

    Background: Bowel function has been reported to be adversely affected following surgery in cases of Hirschsprung. We retrospectively studied both the clinical outcome and bowel function status following surgery in patients diagnosed with Hirschprung′s disease (HD). 161 cases, who underwent pull-through operations for HD in Sheikh Pediatric Tertiary Centre, Mashhad, Iran. The specified time bracket spanned between 2006 and 2011. Materials and Methods: Data was extracted from Health Information...

  20. Different clinical outcomes of Entamoeba histolytica in Malaysia: does genetic diversity exist?

    OpenAIRE

    Anuar, Tengku Shahrul; Al-Mekhlafi, Hesham M.; Abdul Ghani, Mohamed Kamel; Azreen, Siti Nor; Salleh, Fatmah Md; Ghazali, Nuraffini; Bernadus, Mekadina; Moktar, Norhayati

    2013-01-01

    International audience The present study was conducted to investigate the clinical outcomes of Entamoeba histolytica infection in symptomatic and asymptomatic Orang Asli (aborigine) communities in Malaysia. Examination was performed on 500 stool samples obtained from Orang Asli communities in 3 different states using formalin-ether concentration, trichrome staining, and single-round PCR techniques. Out of 500 stool samples, single infection of E. histolytica, Entamoeba dispar, and Entamoeb...

  1. Gender-related variation in the clinical presentation and outcomes of critical limb ischemia

    OpenAIRE

    McCoach, Caroline E.; Armstrong, Ehrin J; Singh, Satinder; Javed, Usman; Anderson, David; Yeo, Khung Keong; Westin, Gregory G; Hedayati, Nasim; Amsterdam, Ezra A.; Laird, John R.

    2013-01-01

    Critical limb ischemia (CLI) is a major cause of limb loss and mortality among patients with advanced peripheral artery disease. Our objective was to evaluate the gender-specific differences in patient characteristics and clinical outcomes among patients with CLI. We performed a retrospective analysis of 97 women and 122 men presenting with CLI who underwent angiography from 2006 to 2010. Baseline demographics, procedural details, and lesion characteristics were assessed for each patient. Kap...

  2. Evaluation of patient perceptions and outcomes related to anticoagulation point-of-care testing in ambulatory care clinics

    Directory of Open Access Journals (Sweden)

    Fermo JD

    2009-12-01

    Full Text Available Until recently, Prothrombin Time/International Normalized Ratio (PT/INR measurements have typically been used to monitor patients on warfarin through institutional laboratories via venous puncture. The Point-of-Care Testing (POCT device has revolutionized the patient care process by allowing for laboratory testing outside of the central laboratory. Objective: To analyze humanistic and clinical outcomes in patients currently treated with warfarin and monitored through a pharmacist-managed anticoagulation clinic using point-of-care testing (POCT device versus venipuncture within ambulatory care clinics at our institution. Methods: All patients currently treated with warfarin therapy who were managed by clinical pharmacists for anticoagulation monitoring at the Medical University of South Carolina (MUSC Family Medicine Center and University Diagnostic Center, were enrolled. Patients were asked to complete a satisfaction survey regarding their anticoagulation monitoring. In addition, data related to emergency department (ED visits, hospitalizations and percent of time in the INR therapeutic range for 6 months pre- and post-implementation of POCT device was collected. This information was obtained through an electronic patient information database, Oacis. Results: A total of 145 patients were included in the data collection from the two clinics. The majority (41% of these patients were taking warfarin for atrial fibrillation. Satisfaction surveys were completed by 86 (59 % of patients. The surveys revealed that POCT device was preferred over venipuncture in 95% of patients. Reasons for the preference included more face-to-face interaction, less wait time, less pain, less blood needed, and quicker results. Of the 145 patients who were included in the objective data analysis, no significant differences were found in the number of hospitalizations, ED visits, or percent of time in the INR therapeutic range pre- and post- implementation of POCT device

  3. Comparative Responsiveness of Pain Outcome Measures Among Primary Care Patients With Musculoskeletal Pain

    Science.gov (United States)

    Krebs, Erin E.; Bair, Matthew J.; Damush, Teresa M.; Tu, Wanzhu; Wu, Jingwei; Kroenke, Kurt

    2016-01-01

    Background Comparative responsiveness data are needed to inform choices about pain outcome measures. Objectives To compare responsiveness of pain intensity, pain-related function, and composite measures, using data from a randomized trial and observational study. Research Design Analysis of responsiveness. Subjects A total of 427 adults with persistent back, hip, or knee pain were recruited from primary care. Methods Participants completed Brief Pain Inventory, Chronic Pain Grade (CPG), Roland disability, SF-36 bodily pain, and pain global rating of change measures. We used the global rating as the anchor for standardized response mean and receiver operating characteristic curve analyses. We used the distribution-based standard error of measurement to estimate minimally important change. To assess responsiveness to the trial intervention, we evaluated standardized effect size statistics stratified by trial arm. Results All measures were responsive to global improvement and all had fair-to-good accuracy in discriminating between participants with and without improvement. SF bodily pain was less responsive than other measures in several analyses. The 3-item PEG was similarly responsive to full Brief Pain Inventory scales. CPG and SF bodily pain were less responsive to the trial intervention and did not perform well among participants with hip/knee pain. Agreement between anchor and distribution-based methods was modest. Conclusions If a brief measure is desired, the 3-item PEG is more responsive than the SF bodily pain scale. CPG and SF bodily pain scales may be relatively poor choices for trial outcome assessment. Both anchor and distribution-based methods should be considered when determining clinically important change. PMID:20856144

  4. Galectin-3, Renal Function, and Clinical Outcomes: Results from the LURIC and 4D Studies.

    Science.gov (United States)

    Drechsler, Christiane; Delgado, Graciela; Wanner, Christoph; Blouin, Katja; Pilz, Stefan; Tomaschitz, Andreas; Kleber, Marcus E; Dressel, Alexander; Willmes, Christoph; Krane, Vera; Krämer, Bernhard K; März, Winfried; Ritz, Eberhard; van Gilst, Wiek H; van der Harst, Pim; de Boer, Rudolf A

    2015-09-01

    Galectin-3 has been linked to incident renal disease, experimental renal fibrosis, and nephropathy. However, the association among galectin-3, renal function, and adverse outcomes has not been described. We studied this association in two large cohorts of patients over a broad range of renal function. We measured galectin-3 concentrations in baseline samples from the German Diabetes mellitus Dialysis (4D) study (1168 dialysis patients with type 2 diabetes mellitus) and the Ludwigshafen Risk and Cardiovascular Health (LURIC) study (2579 patients with coronary angiograms). Patients were stratified into three groups: eGFR of ≥90 ml/min per 1.73 m(2), 60-89 ml/min per 1.73 m(2), and <60 ml/min per 1.73 m(2). We correlated galectin-3 concentrations with demographic, clinical, and biochemical parameters. The association of galectin-3 with clinical end points was assessed by Cox proportional hazards regression within 10 years (LURIC) or 4 years (4D) of follow-up. Mean±SD galectin-3 concentrations were 12.8±4.0 ng/ml (eGFR≥90 ml/min per 1.73 m(2)), 15.6±5.4 ng/ml (eGFR 60-89 ml/min per 1.73 m(2)), 23.1±9.9 ng/ml (eGFR<60 ml/min per 1.73 m(2)), and 54.1±19.6 ng/ml (dialysis patients of the 4D study). Galectin-3 concentration was significantly associated with clinical end points in participants with impaired kidney function, but not in participants with normal kidney function. Per SD increase in log-transformed galectin-3 concentration, the risks of all-cause mortality, cardiovascular mortality, and fatal infection increased significantly. In dialysis patients, galectin-3 was associated with the combined end point of cardiovascular events. In conclusion, galectin-3 concentrations increased with progressive renal impairment and independently associated with cardiovascular end points, infections, and all-cause death in patients with impaired renal function. PMID:25568176

  5. Unidentified Chronic Fatigue Syndrome/myalgic encephalomyelitis (CFS/ME) is a major cause of school absence: surveillance outcomes from school-based clinics

    OpenAIRE

    Crawley, Esther M; Emond, Alan M; Sterne, Jonathan A C

    2011-01-01

    Objective To investigate the feasibility of conducting clinics for chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME) in schools. Design School-based clinical project. Participants Children aged 11–16 years were enrolled in three state secondary schools in England. Main outcome measures Number of children newly diagnosed as having CFS/ME. Methods Attendance officers identified children missing ≥20% of school in a 6-week term without a known cause, excluding those with a single episod...

  6. The EMPA-REG outcome study: critical appraisal and potential clinical implications.

    Science.gov (United States)

    Perseghin, Gianluca; Solini, Anna

    2016-01-01

    Diabetes health care professionals have to face a study with results of incomparable success in secondary and tertiary cardiovascular disease prevention. In the past, no studies in patients with type 2 diabetes resulted to be successful in inducing an improvement of cardiovascular prognosis, no matter whether they were focused on a target, on life-style or on pharmacological intervention. On a clinical perspective, should the diabetologist's way to think about the anti-diabetic therapy of patients on secondary cardiovascular prevention change based on the results of Empa-Reg outcome? Due to the complexity of the clinical picture of patients with type 2 diabetes, a tailored therapy based on targets, complications, co-morbidity, familial and social environment, personal and cultural features must be conceived and applied in starting pharmacological therapy; however, the question whether should we consider empagliflozin as first choice therapy in individuals with type 2 diabetes exposed to high cardiovascular risk, the Empa-Reg outcome-like patient, awaits now for an answer. Waiting for data confirming the results of the Empa-Reg outcome study, this report goes through the good reasons in support of this way of thinking, but at the same time explores the many unanswered questions raising potential concerns about this clinical choice. PMID:27260022

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

    LENUS (Irish Health Repository)

    Keeling, Aoife N

    2012-02-01

    AIM: 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). MATERIALS AND METHODS: Over 7.5 years, 76 patients (CLI 72%, n = 55) underwent below knee PTA. The composite end-point of interest was major adverse clinical outcome (MACO) of the treated limb at follow-up which was defined as clinical failure, need for subsequent endovascular or surgical revascularization or amputation. Actuarial freedom from MACO was assessed using Kaplan-Meier curves and multivariable Cox proportional hazards regression. RESULTS: IC was improved in 95% at mean 3.4 years (range 0.5-108 months). Successful limb salvage and ulcer healing were seen in 73% with CLI. Most failures were in the CLI group (27% CLI vs. 5% IC), with an amputation rate of 16% for CLI vs. 5% for IC and persistent ulceration in 24% of CLI. Significant independent predictors of MACO were ulceration (hazard ratio 4.02, 95% CI = 1.55-10.38) and family history of atherosclerosis (hazard ratio 2.53, 95% CI = 1.1-5.92). CONCLUSION: Primary below knee PTA is a feasible therapeutic option in this elderly population. Limb ulceration and family history of atherosclerosis may be independent predictors of adverse outcome.

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

    Energy Technology Data Exchange (ETDEWEB)

    Keeling, Aoife N.; Khalidi, Karim; Leong, Sum [Department of Academic Radiology, Beaumont Hospital, Beaumont Road, Dublin 9 (Ireland); Wang, Tim T. [Department of Biosurgery and Surgical Technology, Imperial College London, St. Mary' s Hospital, London W2 1NY (United Kingdom); Ayyoub, Alaa S.; McGrath, Frank P. [Department of Academic Radiology, Beaumont Hospital, Beaumont Road, Dublin 9 (Ireland); Athanasiou, Thanos [Department of Biosurgery and Surgical Technology, Imperial College London, St. Mary' s Hospital, London W2 1NY (United Kingdom); Lee, Michael J., E-mail: mlee@rcsi.ie [Department of Academic Radiology, Beaumont Hospital, Beaumont Road, Dublin 9 (Ireland)

    2011-03-15

    Aim: 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). Materials and methods: Over 7.5 years, 76 patients (CLI 72%, n = 55) underwent below knee PTA. The composite end-point of interest was major adverse clinical outcome (MACO) of the treated limb at follow-up which was defined as clinical failure, need for subsequent endovascular or surgical revascularization or amputation. Actuarial freedom from MACO was assessed using Kaplan-Meier curves and multivariable Cox proportional hazards regression. Results: IC was improved in 95% at mean 3.4 years (range 0.5-108 months). Successful limb salvage and ulcer healing were seen in 73% with CLI. Most failures were in the CLI group (27% CLI vs. 5% IC), with an amputation rate of 16% for CLI vs. 5% for IC and persistent ulceration in 24% of CLI. Significant independent predictors of MACO were ulceration (hazard ratio 4.02, 95% CI = 1.55-10.38) and family history of atherosclerosis (hazard ratio 2.53, 95% CI = 1.1-5.92). Conclusion: Primary below knee PTA is a feasible therapeutic option in this elderly population. Limb ulceration and family history of atherosclerosis may be independent predictors of adverse outcome.

  9. Percutaneous coronary intervention in asians- are there differences in clinical outcome?

    Directory of Open Access Journals (Sweden)

    Chua Terrance S

    2011-05-01

    Full Text Available Abstract Background Ethnic differences in clinical outcome after percutaneous coronary intervention (PCI have been reported. Data within different Asian subpopulations is scarce. We aim to explore the differences in clinical profile and outcome between Chinese, Malay and Indian Asian patients who undergo PCI for coronary artery disease (CAD. Methods A prospective registry of consecutive patients undergoing PCI from January 2002 to December 2007 at a tertiary care center was analyzed. Primary endpoint was major adverse cardiovascular events (MACE of myocardial infarction (MI, repeat revascularization and all-cause death at six months. Results 7889 patients underwent PCI; 7544 (96% patients completed follow-up and were included in the analysis (79% males with mean age of 59 years ± 11. There were 5130 (68% Chinese, 1056 (14% Malays and 1001 (13.3% Indian patients. The remaining 357 (4.7% patients from other minority ethnic groups were excluded from the analysis. The primary end-point occurred in 684 (9.1% patients at six months. Indians had the highest rates of six month MACE compared to Chinese and Malays (Indians 12% vs. Chinese 8.2% vs. Malays 10.7%; OR 1.55 95%CI 1.24-1.93, p Conclusion These data indicate that ethnic variations in clinical outcome exist following PCI. In particular, Indian patients have higher six month event rates compared to Chinese and Malays. Future studies are warranted to elucidate the underlying mechanisms behind these variations.

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

    International Nuclear Information System (INIS)

    Aim: 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). Materials and methods: Over 7.5 years, 76 patients (CLI 72%, n = 55) underwent below knee PTA. The composite end-point of interest was major adverse clinical outcome (MACO) of the treated limb at follow-up which was defined as clinical failure, need for subsequent endovascular or surgical revascularization or amputation. Actuarial freedom from MACO was assessed using Kaplan-Meier curves and multivariable Cox proportional hazards regression. Results: IC was improved in 95% at mean 3.4 years (range 0.5-108 months). Successful limb salvage and ulcer healing were seen in 73% with CLI. Most failures were in the CLI group (27% CLI vs. 5% IC), with an amputation rate of 16% for CLI vs. 5% for IC and persistent ulceration in 24% of CLI. Significant independent predictors of MACO were ulceration (hazard ratio 4.02, 95% CI = 1.55-10.38) and family history of atherosclerosis (hazard ratio 2.53, 95% CI = 1.1-5.92). Conclusion: Primary below knee PTA is a feasible therapeutic option in this elderly population. Limb ulceration and family history of atherosclerosis may be independent predictors of adverse outcome.

  11. Clinical outcomes of locked plating of distal femoral fractures in a retrospective cohort

    Science.gov (United States)

    2013-01-01

    Purpose Locked plating (LP) of distal femoral fractures has become very popular. Despite technique suggestions from anecdotal and some early reports, knowledge about risk factors for failure, nonunion (NU), and revision is limited. The purpose of this study was to analyze the complications and clinical outcomes of LP treatment for distal femoral fractures. Materials and methods From two trauma centers, 243 consecutive surgically treated distal femoral fractures (AO/OTA 33) were retrospectively identified. Of these, 111 fractures in 106 patients (53.8% female) underwent locked plate fixation. They had an average age of 54 years (range 18 to 95 years): 34.2% were obese, 18.9% were smokers, and 18.9% were diabetic. Open fractures were present in 40.5% with 79.5% Gustilo type III. Fixation constructs for plate length, working length, and screw concentration were delineated. Nonunion and/or infection, and implant failure were used as outcome complication variables. Outcome was based on surgical method and addressed according to Pritchett for reduction, range of motion, and pain. Results Eighty-three (74.8%) of the fractures healed after the index procedure. Twenty (18.0%) of the patients developed a NU. Four of 20 (20%) resulted in a recalcitrant NU. Length of comminution did not correlate to NU (p = 0.180). Closed injuries had a higher tendency to heal after the index procedure than open injuries (p = 0.057). Closed and minimally open (Gustilo/Anderson types I and II) fractures healed at a significantly higher rate after the index procedure compared to type III open fractures (80.0% versus 61.3%, p = 0.041). Eleven fractures (9.9%) developed hardware failure. Fewer nonunions were found in the submuscular group (10.7%) compared to open reduction (32.0%) (p = 0.023). Fractures above total knee arthroplasties had a significantly greater rate of failed hardware (p = 0.040) and worse clinical outcome according to Pritchett (p = 0.040). Loss of

  12. Results on Differential and Dependent Measurement Error of the Exposure and the Outcome Using Signed Directed Acyclic Graphs

    OpenAIRE

    VanderWeele, Tyler J; Hernán, Miguel A.

    2012-01-01

    Measurement error in both the exposure and the outcome is a common problem in epidemiologic studies. Measurement errors in the exposure and the outcome are said to be independent of each other if the measured exposure and the measured outcome are statistically independent conditional on the true exposure and true outcome (and dependent otherwise). Measurement error is said to be nondifferential if measurement of the exposure does not depend on the true outcome conditional on the true exposure...

  13. Cerebral amyloid angiopathy-related inflammation: imaging findings and clinical outcome

    Energy Technology Data Exchange (ETDEWEB)

    Martucci, Matia [Vall d' Hebron University Hospital, Neuroradiology Unit, Radiology Department (IDI), Barcelona (Spain); Catholic University of Sacred Heart, ' ' A. Gemelli' ' University Hospital, Department of Radiological Sciences, Rome (Italy); Sarria, Silvana; Coscojuela, Pilar; Vert, Carla; Siurana, Sahyly; Auger, Cristina; Rovira, Alex [Vall d' Hebron University Hospital, Neuroradiology Unit, Radiology Department (IDI), Barcelona (Spain); Toledo, Manuel [Vall d' Hebron University Hospital, Epilepsy Unit, Neurology Department, Barcelona (Spain)

    2014-04-15

    We aim to investigate the clinical onset, computed tomography (CT) and magnetic resonance (MR) imaging findings, and follow-up of patients with cerebral amyloid angiopathy (CAA)-related inflammation, an uncommon but clinically striking presentation of CAA. We retrospectively reviewed the clinical manifestations, CT/MR imaging findings, and outcome of ten consecutive patients with CAA-related inflammation. In each patient, a brain CT study was performed at hospital admission, and brain MR imaging was carried out 2 to 4 days later. Clinical and radiologic follow-up findings were evaluated in all patients. The most common clinical onset was rapidly progressive cognitive decline, followed by focal neurological signs. Brain CT/MR showed unenhanced expansive subcortical lesions, corresponding to areas of vasogenic edema, associated with chronic lobar, cortical, or cortical-subcortical micro/macrohemorrhages. Clinical symptoms recovered in a few weeks under treatment in eight patients and spontaneously in the remaining two. MRI follow-up at 2 to 12 months after treatment showed resolution of the lesions. Three patients experienced symptomatic disease recurrence, with new lesions on CT/MR. In the absence of histological data, early recognition of the clinical symptoms and typical radiologic features of CAA-related inflammation is essential to enable timely establishment of proper treatment. (orig.)

  14. Thrombolytic-Related Asymptomatic Hemorrhagic Transformation Does Not Deteriorate Clinical Outcome: Data from TIMS in China.

    Directory of Open Access Journals (Sweden)

    Weihua Jia

    Full Text Available It has been unclear whether thrombolytic-related asymptomatic hemorrhagic transformation (AHT affects the clinical outcome. To answer this question, we examined whether thrombolytic-related AHT affect short-term and long-term clinical outcome.All data were collected from the Thrombolysis Implementation and Monitor of Acute Ischemic Stroke in China (TIMS-China registry. The patients were diagnosed as having AHT group and non- hemorrhagic transformation (HT group based on clinical and imaging data. The patients with symptomatic hemorrhagic transformation were excluded from this study. Thrombolytic-related AHT was defined according to European-Australasian Acute Stroke Study (ECASS II criteria. 90-day functional outcome, 7-day National Institutes of Health Stroke Scale (NIHSS score, 7-day and 90-day mortalities were compared between two groups. Logistic regression analysis was used to evaluate the effects of AHT on a short-term and long-term clinical outcome.904 of all 1440 patients in TIMS-China registry were enrolled. 89 (9.6% patients presented with AHT after thrombolysis within 24-36 h. These patients with AHT were more likely to be elder age, cardioembolic subtype, and to have higher National Institutes of Health Stroke Scale score before thrombolysis than patients without AHT. No significant difference was found on the odds of 7-day (95% CI:0.692 (0.218-2.195, (P = 0.532 or 90-day mortalities (95% CI:0.548 (0.237-1.268, P = 0.160 and modified Rankin Score(0-1 at 90-day (95% CI:0.798 (0.460-1.386, P = 0.423 or modified Rankin Score(0-2 at 90-day (95% CI:0.732 (0.429-1.253, P = 0.116 or modified Rankin Score(5-6 at 90-day (95% CI:0.375 (0.169-1.830, P = 0.116 between two groups.Thrombolytic-related AHT does not deteriorate short-term and long-term clinical outcome.

  15. Effects of clinical practice environments on clinical teacher and nursing student outcomes.

    Science.gov (United States)

    Babenko-Mould, Yolanda; Iwasiw, Carroll L; Andrusyszyn, Mary-Anne; Laschinger, Heather K S; Weston, Wayne

    2012-04-01

    The purpose of this study was to use a cross-sectional survey design, with an integrated theoretical perspective, to examine clinical teachers' (n = 64) and nursing students' (n = 352) empowerment, teachers' and students' perceptions of teachers' use of empowering teaching behaviors, students' perceptions of nurses' practice behaviors, and students' confidence for practice in acute care settings. In this study, teachers and students were moderately empowered. Teachers reported using a high level of empowering teaching behaviors, which corresponded with students' perceptions of teachers' use of such behaviors. Teachers' empowerment predicted 21% of their use of empowering teaching behaviors. Students reported nurses as using a high level of professional practice behaviors. Students felt confident for professional nursing practice. The findings have implications for practice contexts related to empowering teaching-learning environments and self-efficacy. PMID:22432538

  16. An investigation of general predictors for cognitive behavioral therapy outcome for anxiety disorders in a routine clinical setting

    DEFF Research Database (Denmark)

    Nielsen, Sara Kerstine Kaya; Vangkilde, Signe; Wolitzky-Taylor, Kate B.;

    2016-01-01

    predictors of treatment effects are lacking. The aim of this study is to investigate the predictive value of emotion regulation and attentional control for CBT outcome in a routine setting. METHODS AND ANALYSIS: In this prospective and practice-based study, 112 patients with anxiety disorders referred for......-up. Emotion regulation will be measured with Difficulties in Emotion Regulation Questionnaire, severity of anxiety will be assessed with Beck Anxiety Inventory and attentional control will be measured with the self-report questionnaire, Attention Control Scale, and with an experimental computer...... manual-based group CBT at two psychiatric outpatient clinics will be recruited. Emotion regulation, severity of anxiety and attentional control will be assessed with self-report measures and with an experimental computer-based attentional control task at baseline, post-treatment and at a 6-month follow...

  17. Randomized Clinical Investigation of Titanium Implants with and without Platform Switching: Six Months’ Radiographic and Clinical Outcome

    Directory of Open Access Journals (Sweden)

    Roberto Rossi

    2015-04-01

    Full Text Available The aim of this study was to obtain a randomized, clinical and radiological comparison of implants with and without platform switching (PFS. The two compared titanium implant types differed only in the microgap position: test (PFS or control (StE, no PFS. All implants were inserted in posterior regions and followed up for six months after abutment connection (AC. Twenty one patients with 21 PFS and 18 StE implants completed the six-month evaluation. No implant failed. One complication (exposed cap screw was reported at AC. No statistically significant difference was observed between the marginal bone level of PFS and StE implants. Their bone level stabilized approximately 1 mm below the microgap. Based on the outcome of this short-term study with a limited number of patients, it seems unlikely that the optimal clinical and radiological outcome obtained with the tested standard implant (no PFS can be improved by introducing an inward microgap shift (PFS.

  18. Predicting functional remission in patients with schizophrenia: a cross-sectional study of symptomatic remission, psychosocial remission, functioning, and clinical outcome

    Directory of Open Access Journals (Sweden)

    Valencia M

    2015-09-01

    Full Text Available Marcelo Valencia,1 Ana Fresán,2 Yoram Barak,3 Francisco Juárez,1 Raul Escamilla,4 Ricardo Saracco41Division of Epidemiological and Psychosocial Research, 2Division of Clinical Research, National Institute of Psychiatry Ramón de la Fuente, Mexico City, Mexico; 3Psychiatry Department, Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel; 4Schizophrenia Clinic, National Institute of Psychiatry Ramón de la Fuente, Mexico City, MexicoBackground: New approaches to assess outcome in schizophrenia include multidimensional measures such as remission, cognition, psychosocial functioning, and quality of life. Clinical and psychosocial measures have been recently introduced to assess functional outcome.Objective: The study presented here was designed to examine the rates of symptomatic remission, psychosocial remission, global functioning, and clinical global impressions in a sample of schizophrenia outpatients in order to assess functional remission and to identify predictive factors for functional remission.Methods: A total of 168 consecutive Mexican outpatients receiving pharmacological treatment at the National Institute of Psychiatry in Mexico City were enrolled in a cross-sectional study. Symptomatic remission was assessed according to the definition and criteria proposed by the Remission in Schizophrenia Working Group using the Positive and Negative Symptom Scale. Psychosocial remission was assessed according to Barak criteria using the Psychosocial Remission in Schizophrenia scale. Functioning was measured with the Global Assessment of Functioning, and clinical outcome with the Clinical Global Impressions (CGI Scale.Results: Findings showed that 45.2% of patients fulfilled the symptomatic remission criteria, 32.1% achieved psychosocial remission, and 53% reported adequate functioning. However, the combination of these three outcome criteria – symptomatic, psychosocial remission, and functioning – indicated that 14.9% of the

  19. Impact of cardiology referral: clinical outcomes and factors associated with physicians' adherence to recommendations

    Directory of Open Access Journals (Sweden)

    André C. Marques

    2014-12-01

    Full Text Available OBJECTIVES: Cardiology referral is common for patients admitted for non-cardiac diseases. Recommendations from cardiologists may involve complex and aggressive treatments that could be ignored or denied by other physicians. The purpose of this study was to compare the outcomes of patients who were given recommendations during cardiology referrals and to examine the clinical outcomes of patients who did not follow the recommendations. METHODS: We enrolled 589 consecutive patients who received in-hospital cardiology consultations. Data on recommendations, implementation of suggestions and outcomes were collected. RESULTS: Regarding adherence of the referring service to the recommendations, 77% of patients were classified in the adherence group and 23% were classified in the non-adherence group. Membership in the non-adherence group (p<0.001; odds ratio: 10.25; 95% CI: 4.45-23.62 and advanced age (p = 0.017; OR: 1.04; 95% CI: 1.01-1.07 were associated with unfavorable outcomes. Multivariate analysis identified four independent predictors of adherence to recommendations: follow-up notes in the medical chart (p<0.001; OR: 2.43; 95% CI: 1.48-4.01; verbal reinforcement (p = 0.001; OR: 1.86; 95% CI: 1.23-2.81; a small number of recommendation (p = 0.001; OR: 0.87; 95% CI: 0.80-0.94; and a younger patient age (p = 0.002; OR: 0.98; 95% CI: 0.96-0.99. CONCLUSIONS: Poor adherence to cardiology referral recommendations was associated with unfavorable clinical outcomes. Follow-up notes in the medical chart, verbal reinforcement, a limited number of recommendations and a patient age were associated with greater adherence to recommendations.

  20. Prime time: 18-month violence outcomes of a clinic-linked intervention.

    Science.gov (United States)

    Sieving, Renee E; McMorris, Barbara J; Secor-Turner, Molly; Garwick, Ann W; Shlafer, Rebecca; Beckman, Kara J; Pettingell, Sandra L; Oliphant, Jennifer A; Seppelt, Ann M

    2014-08-01

    Prime Time, a youth development intervention, aims to reduce multiple risk behaviors among adolescent girls seeking clinic services who are at high risk for pregnancy. The purpose of the current study was to examine whether Prime Time involvement produced changes in relational aggression, physical violence, and related psychosocial and behavioral outcomes. Qualitative case exemplars illustrated social contexts of intervention participants with differing longitudinal patterns of relational aggression and physical violence. Data were from a randomized efficacy trial with 13-17 year-old girls (n = 253) meeting specified risk criteria. Intervention participants were involved in Prime Time and usual clinic services for 18 months, control participants received usual clinic services. Participants in the current study completed self-report surveys at baseline and 18 months following enrollment. Outcomes analyses revealed significantly lower levels of relational aggression perpetration in the intervention group versus controls. In contrast, Prime Time involvement did not result in significant reductions in physical violence. Exploratory dose-response analyses indicated that reductions in relational aggression may have been most pronounced among girls actively involved in Prime Time case management and peer leadership activities. Qualitative findings suggested that the intervention's emphasis on modeling and building supportive relationships contributed to reductions in relational aggression. This study contributes to what has been a very limited evidence base regarding effective approaches to preventing violence among high-risk adolescent girls. Findings suggest that offering youth development interventions through clinic settings hold promise in reducing violence risk among vulnerable youth. PMID:23543359