Sample records for poor clinical outcomes

  1. Long telomere length predicts poor clinical outcome in esophageal cancer patients.

    PubMed

    Lv, Yanyan; Zhang, Yong; Li, Xinru; Ren, Xiaojuan; Wang, Meichen; Tian, Sijia; Hou, Peng; Shi, Bingyin; Yang, Qi

    2017-02-01

    Abnormal telomere length is widely reported in various human cancers, and it is considered to be an important hallmark of cancer. However, there is remarkably little consensus on the value of telomere length in the prognostic evaluation of esophageal cancers. Here, we attempted to determine the association of variable telomere length with clinical outcome of esophageal cancer patients. Using real-time quantitative PCR, we examined relative telomere lengths (RTL) in a cohort of esophageal cancer and normal esophageal tissues, and statistically investigated the association between RTL and clinical outcomes of esophageal cancer patients. The majority of esophageal cancers in this study had longer RTLs as compared to adjacent non-tumor tissues. Enhanced tumor RTL was associated with smoking habit, poor differentiation, advanced tumor stage, lymph node metastasis and cancer related death. In particular, a close relationship between longer RTL and poor survival was fully demonstrated by using cox regression and Kaplan-Maier survival curves. We found frequent telomere elongation in esophageal cancer tissues, and demonstrated longer RTL may be an independent poor prognostic factor for esophageal cancer patients. Copyright © 2016 Elsevier GmbH. All rights reserved.

  2. Low Cerebral Blood Volume Identifies Poor Outcome in Stent Retriever Thrombectomy

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

    Protto, Sara, E-mail: sara.protto@pshp.fi; Pienimäki, Juha-Pekka; Seppänen, Janne

    BackgroundMechanical thrombectomy (MT) is an efficient treatment of acute stroke caused by large-vessel occlusion. We evaluated the factors predicting poor clinical outcome (3-month modified Rankin Scale, mRS >2) although MT performed with modern stent retrievers.MethodsWe prospectively collected the clinical and imaging data of 105 consecutive anterior circulation stroke patients who underwent MT after multimodal CT imaging. Patients with occlusion of the internal carotid artery and/or middle cerebral artery up to the M2 segment were included. We recorded baseline clinical, procedural and imaging variables, technical outcome, 24-h imaging outcome and the clinical outcome. Differences between the groups were studied with appropriatemore » statistical tests and binary logistic regression analysis.ResultsLow cerebral blood volume Alberta stroke program early CT score (CBV-ASPECTS) was associated with poor clinical outcome (median 7 vs. 9, p = 0.01). Lower collateral score (CS) significantly predicted poor outcome in regression modelling with CS = 0 increasing the odds of poor outcome 4.4-fold compared to CS = 3 (95% CI 1.27–15.5, p = 0.02). Lower CBV-ASPECTS significantly predicted poor clinical outcome among those with moderate or severe stroke (OR 0.82, 95% CI 0.68–1, p = 0.05) or poor collateral circulation (CS 0–1, OR 0.66, 95% CI 0.48–0.90, p = 0.009) but not among those with mild strokes or good collaterals.ConclusionsCBV-ASPECTS estimating infarct core is a significant predictor of poor clinical outcome among anterior circulation stroke patients treated with MT, especially in the setting of poor collateral circulation and/or moderate or severe stroke.« less

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

    PubMed

    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.

  4. The Defect in Autophagy Induction by Clinical Isolates of Mycobacterium Tuberculosis Is Correlated with Poor Tuberculosis Outcomes.

    PubMed

    Li, Furong; Gao, Bo; Xu, Wei; Chen, Ling; Xiong, Sidong

    2016-01-01

    Tuberculosis (TB) represents a major global health problem. The prognosis of clinically active tuberculosis depends on the complex interactions between Mycobacterium tuberculosis (Mtb) and its host. In recent years, autophagy receives particular attention for its role in host defense against intracellular pathogens, including Mtb. In present study, we aim to investigate the relationship of autophagy induction by clinical isolates of Mtb with the clinical outcomes in patients with TB. We collected 185 clinical isolates of Mtb, and determined the effect of these Mtb isolates on autophagy induction in macrophages. It was found that most of clinical isolates of Mtb were able to induce autophagosome formation in macrophages, however, the autophagy-inducing ability varied significantly among different isolates. Of importance, our results revealed that patients infected by Mtb with poor autophagy-inducing ability displayed more severe radiographic extent of disease (p<0.001), and were more likely to have unfavorable treatment outcomes (p<0.001). No significant association was observed between the extent of Mtb-induced autophagy with some socio-demographic characteristics (such as gender, age and tobacco consumption), and some laboratory tests (such as hemoglobin, leukocyte count and erythrocyte sedimentation rate). Furthermore, results from logistic regression analysis demonstrated that the defect in autophagy induction by clinical isolates of Mtb was an independent risk factor for far-advanced radiographic disease (aOR 4.710 [1.93-11.50]) and unfavorable treatment outcomes (aOR 8.309 [2.22-28.97]) in TB. These data indicated that the defect in autophagy induction by Mtb isolates increased the risk of poor clinical outcomes in TB patients, and detection of clinical isolates-induced autophagosome formation might help evaluate the TB outcomes.

  5. Tuberculosis in ageing: high rates, complex diagnosis and poor clinical outcomes.

    PubMed

    Cruz-Hervert, Luis Pablo; García-García, Lourdes; Ferreyra-Reyes, Leticia; Bobadilla-del-Valle, Miriam; Cano-Arellano, Bulmaro; Canizales-Quintero, Sergio; Ferreira-Guerrero, Elizabeth; Báez-Saldaña, Renata; Téllez-Vázquez, Norma; Nava-Mercado, Ariadna; Juárez-Sandino, Luis; Delgado-Sánchez, Guadalupe; Fuentes-Leyra, César Alejandro; Montero-Campos, Rogelio; Martínez-Gamboa, Rosa Areli; Small, Peter M; Sifuentes-Osornio, José; Ponce-de-León, Alfredo

    2012-07-01

    worldwide, the frequency of tuberculosis among older people almost triples that observed among young adults. to describe clinical and epidemiological consequences of pulmonary tuberculosis among older people. we screened persons with a cough lasting more than 2 weeks in Southern Mexico from March 1995 to February 2007. We collected clinical and mycobacteriological information (isolation, identification, drug-susceptibility testing and IS6110-based genotyping and spoligotyping) from individuals with bacteriologically confirmed pulmonary tuberculosis. Patients were treated in accordance with official norms and followed to ascertain treatment outcomes, retreatment, and vital status. eight hundred ninety-three tuberculosis patients were older than 15 years of age; of these, 147 (16.5%) were 65 years of age or older. Individuals ≥ 65 years had significantly higher rates of recently transmitted and reactivated tuberculosis. Older age was associated with treatment failure (OR=5.37; 95% CI: 1.06-27.23; P=0.042), and death due to tuberculosis (HR=3.52; 95% CI: 1.78-6.96; P<0.001) adjusting for sociodemographic and clinical variables. community-dwelling older individuals participate in chains of transmission indicating that tuberculosis is not solely due to the reactivation of latent disease. Untimely and difficult diagnosis and a higher risk of poor outcomes even after treatment completion emphasise the need for specific strategies for this vulnerable group.

  6. Tuberculosis in ageing: high rates, complex diagnosis and poor clinical outcomes

    PubMed Central

    Cruz-Hervert, Luis Pablo; García-García, Lourdes; Ferreyra-Reyes, Leticia; Bobadilla-del-Valle, Miriam; Cano-Arellano, Bulmaro; Canizales-Quintero, Sergio; Ferreira-Guerrero, Elizabeth; Báez-Saldaña, Renata; Téllez-Vázquez, Norma; Nava-Mercado, Ariadna; Juárez-Sandino, Luis; Delgado-Sánchez, Guadalupe; Fuentes-Leyra, César Alejandro; Montero-Campos, Rogelio; Martínez-Gamboa, Rosa Areli; Small, Peter M.; Sifuentes-Osornio, José; Ponce-de-León, Alfredo

    2012-01-01

    Background: worldwide, the frequency of tuberculosis among older people almost triples that observed among young adults. Objective: to describe clinical and epidemiological consequences of pulmonary tuberculosis among older people. Methods: we screened persons with a cough lasting more than 2 weeks in Southern Mexico from March 1995 to February 2007. We collected clinical and mycobacteriological information (isolation, identification, drug-susceptibility testing and IS6110-based genotyping and spoligotyping) from individuals with bacteriologically confirmed pulmonary tuberculosis. Patients were treated in accordance with official norms and followed to ascertain treatment outcomes, retreatment, and vital status. Results: eight hundred ninety-three tuberculosis patients were older than 15 years of age; of these, 147 (16.5%) were 65 years of age or older. Individuals ≥65 years had significantly higher rates of recently transmitted and reactivated tuberculosis. Older age was associated with treatment failure (OR = 5.37; 95% CI: 1.06–27.23; P = 0.042), and death due to tuberculosis (HR = 3.52; 95% CI: 1.78–6.96; P < 0.001) adjusting for sociodemographic and clinical variables. Conclusions: community-dwelling older individuals participate in chains of transmission indicating that tuberculosis is not solely due to the reactivation of latent disease. Untimely and difficult diagnosis and a higher risk of poor outcomes even after treatment completion emphasise the need for specific strategies for this vulnerable group. PMID:22431155

  7. Poor clinical outcomes among pneumonia patients with depressive disorder.

    PubMed

    Kao, Li-Ting; Liu, Shih-Ping; Lin, Herng-Ching; Lee, Hsin-Chien; Tsai, Ming-Chieh; Chung, Shiu-Dong

    2014-01-01

    Some studies suggested that psychological stress may be associated with the severity and duration of infectious diseases. In this population-based study, we investigated associations between depressive disorder (DD) and pneumonia outcomes in Taiwan with a large-scale database from the National Health Insurance. Our study defined 112,198 patients who were hospitalized with a principal diagnosis of pneumonia. We defined their admission date for treatment of pneumonia as the index date. Subsequently, we selected 2,394 patients with DD within 3 years prior to their index date and 11,970 matched patients without DD. We carried out separate conditional logistic regressions to explore the association of clinical pneumonia treatment outcome (ICU admission, use of mechanical ventilation, acute respiratory failure and in-hospital death) with previously diagnosed DD. Patients with DD had a significantly higher probability of an intensive care unit admission (18.1% vs. 12.9%; p<0.001), need for mechanical ventilation (21.9% vs. 18.1%; p<0.001) and in-hospital death (10.4% vs. 9.0%; p = 0.025) than patients without DD. The study showed that pneumonia patients with DD were respectively 1.41- (95% CI: 1.25∼1.59, p<0.001), 1.28- (95% CI: 1.14∼1.43, p<0.001), and 1.17- times (95% CI: 1.01∼1.36, p = 0.039) greater odds of being admitted to the ICU, need for mechanical ventilation, and in-hospital death than patients without DD after adjusting for monthly income, urbanization level, geographic region and Charlson Comorbidity Index score. In conclusion, we found that pneumonia patients with DD were associated with poor treatment outcomes compared to patients without DD.

  8. Association of tumor growth on nude mice and poor clinical outcome in soft tissue sarcoma patients.

    PubMed

    Budach, W; Budach, V

    2001-09-01

    Permanent growth in nude mice (PGNM) may be associated with poor clinical outcome. We tested this hypothesis in a group of soft tissue sarcoma (STS) patients. Small chunks from fresh tumor biopsies of 81 patients with STS were transplanted subcutaneously into NMRI-nu/nu nude mice. Tumor cell lines exhibiting growth in nude mice for more than three tumor passages were considered as permanently established. Clinical outcome of all patients was monitored with a median follow-up of 38 months. 39/81 (48%) STSs exhibited PGNM. High grade, high S-phase proportion, and aneuploidy were significant predictors of PGNM. Overall survival (OS) at 3 years was 21% (+7% standard error of median) for STS patients with PGNM and 53% (+/-8%) for patients without PGNM (P<0.01). Considering only patients without distant metastasis at the time of biopsy (n = 49), 3-year-OS was 25% (+/-10%) and 71% (+/-9%) for STS with PGNM and without PGNM, respectively (P<0.01). In the univariate analysis, PGNM, aneuploidy high S-phase proportion, tumor location at the trunk, high tumor grade, and non-liposarcoma histology were associated with reduced survival time. In the multivariate analysis, aneuploidy and tumor location at the trunk were the only independent predictors of overall survival. Permanent growth of STS on nude mice is associated with poor clinical outcome in the univariate analysis, but is not an independent predictor of survival in the multivariate analysis due to a strong co-correlation to other known adverse prognostic factors.

  9. Dolichoectatic aneurysms of the vertebrobasilar system: clinical and radiographic factors that predict poor outcomes.

    PubMed

    Xu, David S; Levitt, Michael R; Kalani, M Yashar S; Rangel-Castilla, Leonardo; Mulholland, Celene B; Abecassis, Isaac J; Morton, Ryan P; Nerva, John D; Siddiqui, Adnan H; Levy, Elad I; Spetzler, Robert F; Albuquerque, Felipe C; McDougall, Cameron G

    2018-02-01

    OBJECTIVE Fusiform dolichoectatic vertebrobasilar aneurysms are rare, challenging lesions. The natural history of these lesions and medium- and long-term patient outcomes are poorly understood. The authors sought to evaluate patient prognosis after diagnosis of fusiform dolichoectatic vertebrobasilar aneurysms and to identify clinical and radiographic predictors of neurological deterioration. METHODS The authors reviewed multiple, prospectively maintained, single-provider databases at 3 large-volume cerebrovascular centers to obtain data on patients with unruptured, fusiform, basilar artery dolichoectatic aneurysms diagnosed between January 1, 2000, and January 1, 2015. RESULTS A total of 50 patients (33 men, 17 women) were identified; mean clinical follow-up was 50.1 months and mean radiographic follow-up was 32.4 months. At last follow-up, 42% (n = 21) of aneurysms had progressed and 44% (n = 22) of patients had deterioration of their modified Rankin Scale scores. When patients were dichotomized into 2 groups- those who worsened and those who did not-univariate analysis showed 5 variables to be statistically significantly different: sex (p = 0.007), radiographic brainstem compression (p = 0.03), clinical posterior fossa compression (p < 0.001), aneurysmal growth on subsequent imaging (p = 0.001), and surgical therapy (p = 0.006). A binary logistic regression was then created to evaluate these variables. The only variable found to be a statistically significant predictor of clinical worsening was clinical symptoms of posterior fossa compression at presentation (p = 0.01). CONCLUSIONS Fusiform dolichoectatic vertebrobasilar aneurysms carry a poor prognosis, with approximately one-half of the patients deteriorating or experiencing progression of their aneurysm within 5 years. Despite being high risk, intervention-when carefully timed (before neurological decline)-may be beneficial in select patients.

  10. Lack of Early Improvement Predicts Poor Outcome Following Acute Intracerebral Hemorrhage.

    PubMed

    Yogendrakumar, Vignan; Smith, Eric E; Demchuk, Andrew M; Aviv, Richard I; Rodriguez-Luna, David; Molina, Carlos A; Silva Blas, Yolanda; Dzialowski, Imanuel; Kobayashi, Adam; Boulanger, Jean-Martin; Lum, Cheemun; Gubitz, Gord; Padma, Vasantha; Roy, Jayanta; Kase, Carlos S; Bhatia, Rohit; Ali, Myzoon; Lyden, Patrick; Hill, Michael D; Dowlatshahi, Dar

    2018-04-01

    There are limited data as to what degree of early neurologic change best relates to outcome in acute intracerebral hemorrhage. We aimed to derive and validate a threshold for early postintracerebral hemorrhage change that best predicts 90-day outcomes. Derivation: retrospective analysis of collated clinical stroke trial data (Virtual International Stroke Trials Archive). retrospective analysis of a prospective multicenter cohort study (Prediction of haematoma growth and outcome in patients with intracerebral haemorrhage using the CT-angiography spot sign [PREDICT]). Neurocritical and ICUs. Patients with acute intracerebral hemorrhage presenting less than 6 hours. Derivation: 552 patients; validation: 275 patients. None. We generated a receiver operating characteristic curve for the association between 24-hour National Institutes of Health Stroke Scale change and clinical outcome. The primary outcome was a modified Rankin Scale score of 4-6 at 90 days; secondary outcomes were other modified Rankin Scale score ranges (modified Rankin Scale, 2-6, 3-6, 5-6, 6). We employed Youden's J Index to select optimal cut points and calculated sensitivity, specificity, and predictive values. We determined independent predictors via multivariable logistic regression. The derived definitions were validated in the PREDICT cohort. Twenty-four-hour National Institutes of Health Stroke Scale change was strongly associated with 90-day outcome with an area under the receiver operating characteristic curve of 0.75. Youden's method showed an optimum cut point at -0.5, corresponding to National Institutes of Health Stroke Scale change of greater than or equal to 0 (a lack of clinical improvement), which was seen in 46%. Early neurologic change accurately predicted poor outcome when defined as greater than or equal to 0 (sensitivity, 65%; specificity, 73%; positive predictive value, 70%; adjusted odds ratio, 5.05 [CI, 3.25-7.85]) or greater than or equal to 4 (sensitivity, 19%; specificity

  11. Is Asymptomatic Vasospasm Associated With Poor Outcome in Subarachnoid Hemorrhage?

    PubMed Central

    Latorre, Julius Gene S.; Lodi, Yahia; El-Zammar, Ziad; Devasenapathy, Ashok

    2011-01-01

    Background: Vasospasm occurs in up to 70% of aneurysmal subarachnoid hemorrhage (aSAH), but only half becomes symptomatic. It is unclear whether asymptomatic vasospasm (AV) detected by noninvasive testing affects outcome. Prophylactic hemodilutional, hypertensive, and hypervolemic (HHH) therapy is widely used but the benefit remains unproven. We aim to determine whether AV increases the risk of poor outcome and whether HHH is safe. Methods: A total of 175 consecutive patients with aSAH without clinical vasospasm were included. Patients with sonographic (transcranial doppler) or radiologic (computed tomography [CT] Angiography) vasospasm were assigned to AV group, while those without were assigned to no vasospasm (NV) group. Logistic regression was used to determine the association between AV and HHH on poor outcome, defined as modified Rankin scale (mRS) >3 at discharge or 3 to 6 months' follow-up. Results: In all, 106 patients had NV and 25 received HHH. A total of 69 patients had AV and 54 received HHH. Asymptomatic vasospasm compared to NV was not associated with poor outcome (odds ratio [OR] 2.6, 95% confidence interval [CI]: 0.75-8.9; P = .1). Hemodilutional, hypertensive, and hypervolemic use in patients with AV did not improve the outcome (OR 0.16, 95%CI: 0.009-2.84; P = .2). In patients with NV, HHH use showed trend toward poor outcome after multivariable adjustment (OR 12.6, 95%CI: 1.08-146.5 P = .04). Conclusion: Asymptomatic vasospasm does not appear to be associated with poor outcome in aSAH. Hemodilutional, hypertensive, and hypervolemic therapy in AV was not associated with improved outcome and may be harmful to patients who do not have vasospasm. Further research is needed to validate this finding. PMID:23983851

  12. Effect of a Soy Isoflavone Supplement on Lung Function and Clinical Outcomes in Patients With Poorly Controlled Asthma

    PubMed Central

    Smith, Lewis J.; Kalhan, Ravi; Wise, Robert A.; Sugar, Elizabeth A.; Lima, John J.; Irvin, Charles G.; Dozor, Allen J.; Holbrook, Janet T.

    2017-01-01

    IMPORTANCE Soy isoflavone supplements are used to treat several chronic diseases, although the data supporting their use are limited. Some data suggest that supplementation with soy isoflavone may be an effective treatment for patients with poor asthma control. OBJECTIVE To determine whether a soy isoflavone supplement improves asthma control in adolescent and adult patients with poorly controlled disease. DESIGN, SETTING, AND PARTICIPANTS Multicenter, randomized, double-blind, placebo-controlled trial conducted between May 2010 and August 2012 at 19 adult and pediatric pulmonary and allergy centers in the American Lung Association Asthma Clinical Research Centers network. Three hundred eighty-six adults and children aged 12 years or older with symptomatic asthma while taking a controller medicine and low dietary soy intake were randomized, and 345 (89%) completed spirometry at week 24. INTERVENTIONS Participants were randomly assigned to receive soy isoflavone supplement containing 100 mg of total isoflavones (n=193) or matching placebo (n=193) in 2 divided doses administered daily for 24 weeks. MAIN OUTCOMES AND MEASURES The primary outcome measure was change in forced expiratory volume in the first second (FEV1) at 24 weeks. Secondary outcome measures were symptoms, episodes of poor asthma control, Asthma Control Test score (range, 5–25; higher scores indicate better control), and systemic and airway biomarkers of inflammation. RESULTS Mean changes in prebronchodilator FEV1 over 24 weeks were 0.03 L (95% CI, −0.01 to 0.08 L) in the placebo group and 0.01 L (95% CI, −0.07 to 0.07 L) in the soy isoflavone group, which were not significantly different (P = .36). Mean changes in symptom scores on the Asthma Control Test (placebo, 1.98 [95% CI, 1.42–2.54] vs soy isoflavones, 2.20 [95% CI, 1.53–2.87]; positive values indicate a reduction in symptoms), number of episodes of poor asthma control (placebo, 3.3 [95% CI, 2.7–4.1] vs soy isoflavones, 3.0 [95% CI

  13. Social cognitive markers of short-term clinical outcome in first-episode psychosis.

    PubMed

    Montreuil, Tina; Bodnar, Michael; Bertrand, Marie-Claude; Malla, Ashok K; Joober, Ridha; Lepage, Martin

    2010-07-01

    In psychotic disorders, impairments in cognition have been associated with both clinical and functional outcome, while deficits in social cognition have been associated with functional outcome. As an extension to a recent report on neurocognition and short-term clinical outcome in first-episode psychosis (FEP), the current study explored whether social cognitive deficits could also identify poor short-term clinical outcome among FEP patients. We defined the social-cognition domain based on the scores from the Hinting Task and the Four Factor Tests of Social Intelligence. Data were collected in 45 FEP patients and 26 healthy controls. The patients were divided into good- and poor-outcome groups based on clinical data at six months following initiation of treatment. Social cognition was compared among 27 poor-outcome, 18 good-outcome, and 26 healthy-control participants. Outcome groups significantly differed in the social cognition domain (z-scores: poor outcome=-2.0 [SD=1.4]; good outcome=-1.0 [SD=1.0]; p=0.005), with both groups scoring significantly lower than the control group (p<0.003). Moreover, outcome groups differed significantly only on the Cartoon Predictions subtest (z-scores: poor outcome=-2.7 [SD=2.7]; good outcome=-0.7 [SD=1.8]; p=0.001) among the five subtests used. Overall, social cognition appears to be compromised in all FEP patients compared to healthy controls. More interestingly, significant differences in social cognitive impairments exist between good and poor short-term clinical outcome groups, with the largest effect found in the Cartoon Predictions subtest.

  14. Effect of a soy isoflavone supplement on lung function and clinical outcomes in patients with poorly controlled asthma: a randomized clinical trial.

    PubMed

    Smith, Lewis J; Kalhan, Ravi; Wise, Robert A; Sugar, Elizabeth A; Lima, John J; Irvin, Charles G; Dozor, Allen J; Holbrook, Janet T

    2015-05-26

    Soy isoflavone supplements are used to treat several chronic diseases, although the data supporting their use are limited. Some data suggest that supplementation with soy isoflavone may be an effective treatment for patients with poor asthma control. To determine whether a soy isoflavone supplement improves asthma control in adolescent and adult patients with poorly controlled disease. Multicenter, randomized, double-blind, placebo-controlled trial conducted between May 2010 and August 2012 at 19 adult and pediatric pulmonary and allergy centers in the American Lung Association Asthma Clinical Research Centers network. Three hundred eighty-six adults and children aged 12 years or older with symptomatic asthma while taking a controller medicine and low dietary soy intake were randomized, and 345 (89%) completed spirometry at week 24. Participants were randomly assigned to receive soy isoflavone supplement containing 100 mg of total isoflavones (n=193) or matching placebo (n=193) in 2 divided doses administered daily for 24 weeks. The primary outcome measure was change in forced expiratory volume in the first second (FEV1) at 24 weeks. Secondary outcome measures were symptoms, episodes of poor asthma control, Asthma Control Test score (range, 5-25; higher scores indicate better control), and systemic and airway biomarkers of inflammation. Mean changes in prebronchodilator FEV1 over 24 weeks were 0.03 L (95% CI, -0.01 to 0.08 L) in the placebo group and 0.01 L (95% CI, -0.07 to 0.07 L) in the soy isoflavone group, which were not significantly different (P = .36). Mean changes in symptom scores on the Asthma Control Test (placebo, 1.98 [95% CI, 1.42-2.54] vs soy isoflavones, 2.20 [95% CI, 1.53-2.87]; positive values indicate a reduction in symptoms), number of episodes of poor asthma control (placebo, 3.3 [95% CI, 2.7-4.1] vs soy isoflavones, 3.0 [95% CI, 2.4-3.7]), and changes in exhaled nitric oxide (placebo, -3.48 ppb [95% CI, -5.99 to -0.97 ppb] vs soy

  15. Low free triiodothyronine predicts poor functional outcome after acute ischemic stroke.

    PubMed

    Suda, Satoshi; Muraga, Kanako; Kanamaru, Takuya; Okubo, Seiji; Abe, Arata; Aoki, Junya; Suzuki, Kentaro; Sakamoto, Yuki; Shimoyama, Takashi; Nito, Chikako; Kimura, Kazumi

    2016-09-15

    The aim of this study was to investigate the association of admission serum thyroid hormone concentration with clinical characteristics and functional outcomes in patients after acute ischemic stroke. We retrospectively enrolled 398 consecutive patients admitted to our stroke center between July 2010 and April 2012. Serum thyroid stimulating hormone (TSH), free triiodothyronine (FT3), and free thyroxine (FT4) were evaluated upon admission. Neurological severity was evaluated using the National Institutes of Health Stroke Scale (NIHSS) upon admission and the modified Rankin Scale (mRS) upon discharge. Poor outcome was defined as a mRS score of 3-5 or death (mRS score 6). Separate analyses were conducted according to outcome and quartile serum FT3 concentration. In total, 164 patients (41.2%) demonstrated a poor outcome. Age, male gender, blood glucose level, arterial fibrillation, dyslipidemia, smoking, NIHSS score, cardioembolic stroke type, and periventricular hyperintensities, but not FT4 or TSH, were significantly associated with poor functional outcome. Furthermore, poor functional outcome was independently associated with low FT3 (<2.29pg/mL). In comparisons between FT3 quartiles (Q1 [≤2.11pg/mL], Q2 [2.12-2.45pg/mL], Q3 [2.46-2.77pg/mL], Q4 [≥2.78pg/mL]), patients with poor outcomes were more frequent in Q1 than in Q4 after multivariate adjustment. Death was more frequent in Q1 than in Q4 after adjustment for risk factors and comorbidities, but this difference was non-significant after additional adjustment for age and NIHSS score. Our data suggest that a lower FT3 value upon admission may predict a poor functional outcome in patients with acute ischemic stroke. Further large-scale prospective studies are required to clarify the role of thyroid hormone in the acute phase of ischemic stroke. Copyright © 2016 Elsevier B.V. All rights reserved.

  16. Fluid Overload is Associated with Late Poor Outcomes in Neonates Following Cardiac Surgery

    PubMed Central

    Wilder, Nicole S; Yu, Sunkyung; Donohue, Janet E; Goldberg, Caren S; Blatt, Neal B

    2016-01-01

    Objective Acute kidney injury (AKI) is a severe complication of cardiac surgery associated with increased morbidity and mortality, yet AKI classification for neonates remains challenging. We characterized patterns of post-operative fluid overload (FO) as a surrogate marker for AKI and as a risk factor of poor post-operative outcomes in neonates undergoing cardiac surgery. Design Retrospective cohort study. Setting Single, congenital heart center destination program. Patients 435 neonates undergoing cardiac surgery with cardiopulmonary bypass from January 2006 through December 2010. Interventions None Measurements and Main Results Demographics, diagnosis, and perioperative clinical variables were collected, including daily weights and serum creatinine (SCr) levels. A composite poor clinical outcome (death, need for renal replacement therapy (RRT), or extracorporeal life support (ECLS) within 30 post-operative days) was considered the primary outcome measure. Twenty-one neonates (5%) had a composite poor outcome with 7 (2%) requiring RRT, 8 (2%) requiring ECLS, and 14 (3%) dying between 3 and 30 days post-surgery. Neonates with a composite poor outcome had significantly higher maximum FO (>20%) and were slower to diurese. A receiver-operating characteristic curve determined that FO ≥ 16% and SCr ≥ 0.9 on post-operative day 3 were the optimal cutoffs for significant discrimination on the primary outcome (area under the curve = 0.71 and 0.76, respectively). In multivariable analysis, FO ≥ 16% (adjusted odds ratio [AOR] = 3.7) and SCr ≥ 0.9 (AOR = 6.6) on post-operative day 3 remained an independent risk factor for poor outcome. FO ≥ 16% was also significantly associated with cardiac arrest requiring cardiopulmonary resuscitation, prolonged intensive care unit stay, and chest re-exploration. Conclusions This study highlights the importance of monitoring fluid balance in the neonatal cardiac surgical population, and suggests that daily FO, a readily

  17. Electroencephalography Predicts Poor and Good Outcomes After Cardiac Arrest: A Two-Center Study.

    PubMed

    Rossetti, Andrea O; Tovar Quiroga, Diego F; Juan, Elsa; Novy, Jan; White, Roger D; Ben-Hamouda, Nawfel; Britton, Jeffrey W; Oddo, Mauro; Rabinstein, Alejandro A

    2017-07-01

    The prognostic role of electroencephalography during and after targeted temperature management in postcardiac arrest patients, relatively to other predictors, is incompletely known. We assessed performances of electroencephalography during and after targeted temperature management toward good and poor outcomes, along with other recognized predictors. Cohort study (April 2009 to March 2016). Two academic hospitals (Centre Hospitalier Universitaire Vaudois, Lausanne, Switzerland; Mayo Clinic, Rochester, MN). Consecutive comatose adults admitted after cardiac arrest, identified through prospective registries. All patients were managed with targeted temperature management, receiving prespecified standardized clinical, neurophysiologic (particularly, electroencephalography during and after targeted temperature management), and biochemical evaluations. We assessed electroencephalography variables (reactivity, continuity, epileptiform features, and prespecified "benign" or "highly malignant" patterns based on the American Clinical Neurophysiology Society nomenclature) and other clinical, neurophysiologic (somatosensory-evoked potential), and biochemical prognosticators. Good outcome (Cerebral Performance Categories 1 and 2) and mortality predictions at 3 months were calculated. Among 357 patients, early electroencephalography reactivity and continuity and flexor or better motor reaction had greater than 70% positive predictive value for good outcome; reactivity (80.4%; 95% CI, 75.9-84.4%) and motor response (80.1%; 95% CI, 75.6-84.1%) had highest accuracy. Early benign electroencephalography heralded good outcome in 86.2% (95% CI, 79.8-91.1%). False positive rates for mortality were less than 5% for epileptiform or nonreactive early electroencephalography, nonreactive late electroencephalography, absent somatosensory-evoked potential, absent pupillary or corneal reflexes, presence of myoclonus, and neuron-specific enolase greater than 75 µg/L; accuracy was highest for

  18. Higher leukocyte count predicts 3-month poor outcome of ruptured cerebral aneurysms.

    PubMed

    Yao, Pei-Sen; Chen, Guo-Rong; Xie, Xue-Ling; Shang-Guan, Huang-Cheng; Gao, Jin-Zhen; Lin, Yuan-Xiang; Zheng, Shu-Fa; Lin, Zhang-Ya; Kang, De-Zhi

    2018-04-11

    It is not fully established whether leukocyte can predict the poor outcome for ruptured cerebral aneurysms (CA) or not. Here, we retrospectively analyzed the clinical data of 428 patients with ruptured CA between 2010 and 2015. Patients' demographic data, including gender, age, history of smoking, alcohol, hypertension, diabetes and hypercholesterolemia, Hunt-Hess and Fisher grade, occurrence of hydrocephalus, aneurysm location, time to surgery, delayed ischemic neurological deficit (DIND) and peak leukocyte of blood test from day 1 to 3 after aneurysmal rupture were recorded and analyzed. In the multivariable analysis model, gender, Fisher grade, time to surgery and hydrocephalus were not relevant to poor outcome. However, Hunt-Hess grade, DIND and preoperative leukocyte count (>13.84 × 10 9 /L) were significantly associated with adverse outcome. The respective increased risks were 5.2- (OR5.24, 95% CI 1.67-16.50, p = 0.005), 6.2-(OR 6.24, 95% CI 3.55-10.99, p < 0.001) and 10.9-fold (OR 9.35, 95% CI 5.98-19.97, p < 0.001). The study revealed that Hunt-Hess grade, DIND and preoperative leukocyte count (>13.84 × 10 9 /L) were independent risk factors for poor outcome of ruptured CA at 3 months. Higher leukocyte count is a convenient and useful marker to predict 3-month poor outcome for ruptured CA.

  19. Communication failures during clinical handovers lead to a poor patient outcome: Lessons from a case report.

    PubMed

    Manias, Elizabeth; Geddes, Fiona; Watson, Bernadette; Jones, Dorothy; Della, Phillip

    2015-01-01

    In the emergency department, communication failures occur in clinical handover due to the urgent, changing and unpredictable nature of care provision. We present a case report of a female patient who was assaulted, and identify how various factors interacted to produce communication failures at multiple clinical handovers, leading to a poor patient outcome. Several handovers created many communication failures at diverse time points. The bedside medical handover produced misunderstandings during verbal exchange of information between emergency department consultants and junior doctors, and there was miscommunication involving plastic registrars. There was a failure in adequately informing the general practitioner and the patient relating to follow-up care after discharge. Deficiencies of communication occurred with conveying changes in an investigative report. Communication could be improved by dividing the conduct of handover in a quiet room and at the bedside, ensuring multiple sources of information are used and encouraging role-modelling behaviours for junior clinicians.

  20. Leukoaraiosis predicts poor 90-day outcome after acute large cerebral artery occlusion.

    PubMed

    Henninger, Nils; Lin, Eugene; Baker, Stephen P; Wakhloo, Ajay K; Takhtani, Deepak; Moonis, Majaz

    2012-01-01

    To date limited information regarding outcome-modifying factors in patients with acute intracranial large artery occlusion (ILAO) in the anterior circulation is available. Leukoaraiosis (LA) is a common finding among patients with ischemic stroke and has been associated with poor post-stroke outcomes but its association with ILAO remains poorly characterized. This study sought to clarify the contribution of baseline LA and other common risk factors to 90-day outcome (modified Rankin Scale, mRS) after stroke due to acute anterior circulation ILAO. We retrospectively analyzed 1,153 consecutive patients with imaging-confirmed ischemic stroke during a 4-year period (2007-2010) at a single academic institution. The final study cohort included 87 patients with acute ILAO subjected to multimodal CT imaging within 24 h of symptom onset. LA severity was assessed using the van Swieten scale on non-contrast CT. Leptomeningeal collaterals were graded using CT angiogram source images. Hemorrhagic transformation (HT) was determined on follow-up CT. Multivariate logistic regression controlling for HT, treatment modality, demographic, as well as baseline clinical and imaging characteristics was used to identify independent predictors of a poor outcome (90-day mRS >2). The median National Institutes of Health Stroke Scale (NIHSS) at baseline was 15 (interquartile range 9-21). Twenty-four percent of the studied patients had severe LA. They were more likely to have hypertension (p = 0.028), coronary artery disease (p = 0.015), poor collaterals (p < 0.001), higher baseline NIHSS (p = 0.003), higher mRS at 90 days (p < 0.001), and were older (p = 0.002). Patients with severe LA had a uniformly poor outcome (p < 0.001) irrespective of treatment modality. Poor outcome was independently associated with higher baseline NIHSS (p < 0.001), worse LA (graded and dichotomized, p < 0.001), reduced leptomeningeal collaterals (graded and dichotomized, p < 0.001), presence of HT (p < 0

  1. Identifying Children With Poor Cochlear Implantation Outcomes Using Massively Parallel Sequencing

    PubMed Central

    Wu, Chen-Chi; Lin, Yin-Hung; Liu, Tien-Chen; Lin, Kai-Nan; Yang, Wei-Shiung; Hsu, Chuan-Jen; Chen, Pei-Lung; Wu, Che-Ming

    2015-01-01

    Abstract Cochlear implantation is currently the treatment of choice for children with severe to profound hearing impairment. However, the outcomes with cochlear implants (CIs) vary significantly among recipients. The purpose of the present study is to identify the genetic determinants of poor CI outcomes. Twelve children with poor CI outcomes (the “cases”) and 30 “matched controls” with good CI outcomes were subjected to comprehensive genetic analyses using massively parallel sequencing, which targeted 129 known deafness genes. Audiological features, imaging findings, and auditory/speech performance with CIs were then correlated to the genetic diagnoses. We identified genetic variants which are associated with poor CI outcomes in 7 (58%) of the 12 cases; 4 cases had bi-allelic PCDH15 pathogenic mutations and 3 cases were homozygous for the DFNB59 p.G292R variant. Mutations in the WFS1, GJB3, ESRRB, LRTOMT, MYO3A, and POU3F4 genes were detected in 7 (23%) of the 30 matched controls. The allele frequencies of PCDH15 and DFNB59 variants were significantly higher in the cases than in the matched controls (both P < 0.001). In the 7 CI recipients with PCDH15 or DFNB59 variants, otoacoustic emissions were absent in both ears, and imaging findings were normal in all 7 implanted ears. PCDH15 or DFNB59 variants are associated with poor CI performance, yet children with PCDH15 or DFNB59 variants might show clinical features indistinguishable from those of other typical pediatric CI recipients. Accordingly, genetic examination is indicated in all CI candidates before operation. PMID:26166082

  2. Prognostic indicators of poor short-term outcome of physiotherapy intervention in women with stress urinary incontinence.

    PubMed

    Hendriks, Erik J M; Kessels, Alfons G H; de Vet, Henrica C W; Bernards, Arnold T M; de Bie, Rob A

    2010-03-01

    To identify prognostic indicators independently associated with poor outcome of physiotherapy intervention in women with primary or recurrent stress urinary incontinence (stress UI). A prospective cohort study was performed in physiotherapy practices in primary care to identify prognostic indicators 12 weeks after initiation of physiotherapy intervention. Patients were referred by general practitioners or urogynecologists. Risk factors for stress UI were examined as potential prognostic indicators of poor outcome. The primary outcomes were defined as poor outcome on the binary Leakage Severity scale (LS scale) and the binary global perceived effectiveness (GPE) score. Two hundred sixty-seven women, with a mean age of 47.7 (SD = 8.3), with stress UI for at least 6 months were included. At 12 weeks, 43% and 59% of the women were considered recovered on the binary LS scale and the binary GPE score, respectively. Prognostic indicators associated with poor outcome included 11 indicators based on the binary LS scale and 8 based on the binary GPE score. The prognostic indicators shared by both models show that poor recovery was associated with women with severe stress UI, POP-Q stage > II, poor outcome of physiotherapy intervention for a previous UI episode, prolonged second stage of labor, BMI > 30, high psychological distress, and poor physical health. This study provides robust evidence of clinically meaningful prognostic indicators of poor short-term outcome. These findings need to be confirmed by replication studies. (c) 2009 Wiley-Liss, Inc.

  3. Inflammation, edema and poor outcome are associated with hyperthermia in hypertensive intracerebral hemorrhages.

    PubMed

    Iglesias-Rey, Ramón; Rodríguez-Yáñez, Manuel; Arias, Susana; Santamaría, María; Rodríguez-Castro, Emilio; López-Dequidt, Iria; Hervella, Pablo; Sobrino, Tomás; Campos, Francisco; Castillo, José

    2018-05-11

    The deleterious effect of hyperthermia on intracerebral hemorrhage (ICH) has been studied, however the results are not completely conclusive and new studies are needed to elucidate clinical factors that condition the poor outcome. The aim of this study was to identify the clinical factors (including ICH etiology) that influence the poor outcome associated with hyperthermia on ICH. We additionally tried to identify potential mechanisms involved in hyperthermia during ICH. From a prospective registry, we conducted a retrospective study enrolling non-traumatic ICH patients. We used logistic regression models to analyze the influence of hyperthermia in relation to different inflammatory and endothelial dysfunction markers, hematoma growth and edema volume in hypertensive and non-hypertensive ICH patients. We included 887 ICH patients: 433 hypertensive, 50 amyloid, 117 by anticoagulants and 287 by other causes. Patients with hypertensive ICH showed the higher body temperature (37.5±0.8°C) as well as the maximum increase in temperature (0.9±0.1°C) within the first 24 hours. ICH patients with hypertensive etiologic origin, who presented hyperthermia, showed a 5.3 fold-higher risk to have poor outcome at 3 months. We found a positive relationship (r=0.717, P<0.0001) between edema volume and hyperthermia during the first 24 hours but only in ICH patients with hypertensive etiologic origin, and this relationship seems to be mediated by inflammatory markers. Our data suggest that hyperthermia, together with inflammation and edema is associated with poor outcome only in ICH from hypertensive etiology. This article is protected by copyright. All rights reserved. This article is protected by copyright. All rights reserved.

  4. Genomic copy number gains of ErbB family members predict poor clinical outcomes in glioma patients

    PubMed Central

    Liu, Rui; Qu, Yiping; Chen, Lihong; Pu, Jun; Ma, Sharui; Zhang, Xiaozhi; Yang, Qi; Shi, Bingyin; Hou, Peng; Ji, Meiju

    2017-01-01

    The aim of this study was to investigate copy number of ErbB family members (including EGFR, HER2, HER3 and HER4) in a cohort of gliomas and benign meningiomas (control subjects), and explore the associations of their copy number with clinicopathological characteristics and clinical outcomes of glioma patients. Using real-time quantitative PCR assay, we demonstrated that copy number of EGFR, HER2, HER3 and HER4 in glioma patients was significantly increased compared to control subjects. Moreover, our data also showed that the risk of cancer-related death was positively associated with copy number gain (CNG) of EGFR, HER3 and HER4, but not HER2. CNG of EGFR and HER2 was positively related to radiotherapy, while CNG of HER3 and HER4 was negatively related to chemotherapy. Importantly, EGFR CNG significantly shortened median survival times of glioma patients regardless of gender, tumor grade and therapeutic regimens. Stratified analysis showed that CNG of HER2-4 almost did not influence the survival of male patients, patients with high-grade tumors and patients receiving chemotherapy, but dramatically shortened median survival times of female patients, those with low-grade tumors and those receiving radiotherapy. Collectively, our data not only demonstrate that the members of ErbB family are frequently amplified in gliomas, but also suggest that these common genetic events may be prognostic factors for poor clinical outcomes in glioma patients. PMID:29190914

  5. Therapist strategies early in therapy associated with good or poor outcomes among clients with low proactive agency.

    PubMed

    von der Lippe, Anna Louise; Oddli, Hanne Weie; Halvorsen, Margrethe Seeger

    2017-09-10

    Within a mixed methods program of research the present study aimed at expanding knowledge about interactions in the initial therapeutic collaboration by combining focus on client interpersonal style and therapist contribution. The study involves in-depth analyses of therapist-client interactions in the initial two sessions of good and poor outcome therapies. Based on interpersonal theory and previous research, the Inventory of Interpersonal Problems (IIP-64-C) was used to define poor outcome cases, that is, low proactive agency cases. To compare good and poor outcome cases matched on this interpersonal pattern, cases were drawn from two different samples; nine poor outcome cases from a large multi-site outpatient clinic study and nine good outcome cases from a process-outcome study of highly experienced therapists. Qualitative analysis of therapist behaviors resulted in 2 main categories, fostering client's proactive agentic involvement in change work and discouraging client's proactive agentic involvement in change work, 8 categories and 22 sub-categories. The findings revealed distinct and cohesive differences in therapist behaviors between the two outcome groups, and point to the particular therapist role of fostering client agency through engagement in a shared work on change when clients display strong unassertiveness and low readiness for change. Clinical or Methodological Significance Summary: The present analysis combines focus on client interpersonal style, therapist strategies/process and outcome. The categories generated from the present grounded theory analysis may serve as a foundation for identifying interactions that are associated with agentic involvement in future process research and practice, and hence we have formulated principles/strategies that were identified by the analysis.

  6. Brainstem leukoaraiosis independently predicts poor outcome after ischemic stroke.

    PubMed

    Giralt-Steinhauer, E; Medrano, S; Soriano-Tárraga, C; Mola-Caminal, M; Rasal, R; Cuadrado-Godia, E; Rodríguez-Campello, A; Ois, A; Capellades, J; Jimenez-Conde, J; Roquer, J

    2018-04-16

    Increased supratentorial white matter hyperintensities volume (S-WMHV) has been reported to be a predictor of worse outcome in patients with acute ischemic stroke (AIS). However, few studies have focused on less common locations, such as brainstem white matter hyperintensities (B-WMH), and their relationship to S-WMHV. This study aimed to examine whether B-WMH affect clinical outcome after AIS or transient ischemic attack (TIA). Based on magnetic resonance imaging evidence, B-WMH were evaluated in 313 prospectively identified patients with AIS/TIA and registered as absent or present. Standardized S-WMHV was quantified using a validated volumetric image analysis and natural log-transformed (Log_S-WMHV). Poor outcome was defined as a modified Rankin Scale score of 3-6 at 3 months after the index event. Brainstem white matter hyperintensities were detected in 57 (18.2%) patients. In unadjusted analyses for outcome, the presence of B-WMH was associated with worse outcome, compared with patients without B-WMH (P = 0.034). In multivariate analysis controlling for age, atrial fibrillation, stroke severity, reperfusion therapies and Log_S-WMHV, only B-WMH [odds ratio (OR), 2.46; P = 0.021] and stroke severity (OR, 1.23; P < 0.001) remained independently associated with unfavourable 90-day modified Rankin Scale score. Patients with B-WMH were older (OR, 1.06; P < 0.001) and tended to have more hyperlipidaemia (OR, 2.21; P = 0.023) and peripheral arterial disease (OR, 2.57; P = 0.031). Brainstem white matter hyperintensities are an independent predictor of poor outcome after AIS/TIA and this relationship persists after adjustment for important prognostic factors. Our results also show that leukoaraiosis in this location identifies patients with a specific risk factor profile, suggesting differences in the underlying pathogenesis. © 2018 EAN.

  7. Comparison of mild and microdose GnRH agonist flare protocols on IVF outcome in poor responders.

    PubMed

    Karimzadeh, Mohammad Ali; Mashayekhy, Mehri; Mohammadian, Farnaz; Moghaddam, Fatemeh Mansoori

    2011-05-01

    To compare the IVF outcome of clomiphene citrate/gonadotropin/antagonist (mild protocol) and microdose GnRH agonist flare protocols for poor responders undergoing in vitro fertilization. 159 poor responder patients were randomized and ovarian stimulation was performed with clomiphene citrate, gonadotropin and antagonist (group I) or microdose GnRH agonist flare (group II) protocols. Main outcome was clinical pregnancy rate and secondary outcomes were doses of gonadotropin administration and duration of stimulation. There were no significant differences in age, causes of infertility, basal FSH, BMI, duration of infertility, E(2) level on the day of hCG injection in both groups. Although the cancellation, fertilization, and clinical pregnancy rates were similar in both groups, the endometrial thickness, number of retrieved oocytes, mature oocytes and implantation rate were significantly higher in mild protocol. The doses of gonadotropin administration and duration of stimulation were significantly lower in mild protocol. We recommend mild protocol in assisted reproductive technology cycles for poor responders based on our results regarding less doses of used gonadotropin and a shorter duration of stimulation.

  8. Gasdermin B expression predicts poor clinical outcome in HER2-positive breast cancer

    PubMed Central

    Hergueta-Redondo, Marta; Sarrio, David; Molina-Crespo, Ángela; Vicario, Rocío; Bernadó-Morales, Cristina; Martínez, Lidia; Rojo-Sebastián, Alejandro; Serra-Musach, Jordi; Mota, Alba; Martínez-Ramírez, Ángel; Castilla, Maria Ángeles; González-Martin, Antonio; Pernas, Sonia; Cano, Amparo; Cortes, Javier; Nuciforo, Paolo G.; Peg, Vicente; Palacios, José; Pujana, Miguel Ángel; Arribas, Joaquín; Moreno-Bueno, Gema

    2016-01-01

    Around, 30–40% of HER2-positive breast cancers do not show substantial clinical benefit from the targeted therapy and, thus, the mechanisms underlying resistance remain partially unknown. Interestingly, ERBB2 is frequently co-amplified and co-expressed with neighbour genes that may play a relevant role in this cancer subtype. Here, using an in silico analysis of data from 2,096 breast tumours, we reveal a significant correlation between Gasdermin B (GSDMB) gene (located 175 kilo bases distal from ERBB2) expression and the pathological and clinical parameters of poor prognosis in HER2-positive breast cancer. Next, the analysis of three independent cohorts (totalizing 286 tumours) showed that approximately 65% of the HER2-positive cases have GSDMB gene amplification and protein over-expression. Moreover, GSDMB expression was also linked to poor therapeutic responses in terms of lower relapse free survival and pathologic complete response as well as positive lymph node status and the development of distant metastasis under neoadjuvant and adjuvant treatment settings, respectively. Importantly, GSDMB expression promotes survival to trastuzumab in different HER2-positive breast carcinoma cells, and is associated with trastuzumab resistance phenotype in vivo in Patient Derived Xenografts. In summary, our data identifies the ERBB2 co-amplified and co-expressed gene GSDMB as a critical determinant of poor prognosis and therapeutic response in HER2-positive breast cancer. PMID:27462779

  9. Gasdermin B expression predicts poor clinical outcome in HER2-positive breast cancer.

    PubMed

    Hergueta-Redondo, Marta; Sarrio, David; Molina-Crespo, Ángela; Vicario, Rocío; Bernadó-Morales, Cristina; Martínez, Lidia; Rojo-Sebastián, Alejandro; Serra-Musach, Jordi; Mota, Alba; Martínez-Ramírez, Ángel; Castilla, Mª Ángeles; González-Martin, Antonio; Pernas, Sonia; Cano, Amparo; Cortes, Javier; Nuciforo, Paolo G; Peg, Vicente; Palacios, José; Pujana, Miguel Ángel; Arribas, Joaquín; Moreno-Bueno, Gema

    2016-08-30

    Around, 30-40% of HER2-positive breast cancers do not show substantial clinical benefit from the targeted therapy and, thus, the mechanisms underlying resistance remain partially unknown. Interestingly, ERBB2 is frequently co-amplified and co-expressed with neighbour genes that may play a relevant role in this cancer subtype. Here, using an in silico analysis of data from 2,096 breast tumours, we reveal a significant correlation between Gasdermin B (GSDMB) gene (located 175 kilo bases distal from ERBB2) expression and the pathological and clinical parameters of poor prognosis in HER2-positive breast cancer. Next, the analysis of three independent cohorts (totalizing 286 tumours) showed that approximately 65% of the HER2-positive cases have GSDMB gene amplification and protein over-expression. Moreover, GSDMB expression was also linked to poor therapeutic responses in terms of lower relapse free survival and pathologic complete response as well as positive lymph node status and the development of distant metastasis under neoadjuvant and adjuvant treatment settings, respectively. Importantly, GSDMB expression promotes survival to trastuzumab in different HER2-positive breast carcinoma cells, and is associated with trastuzumab resistance phenotype in vivo in Patient Derived Xenografts. In summary, our data identifies the ERBB2 co-amplified and co-expressed gene GSDMB as a critical determinant of poor prognosis and therapeutic response in HER2-positive breast cancer.

  10. Poor versus rich children with epilepsy have the same clinical course and remission rates but a less favorable social outcome: A population-based study with 25 years of follow-up.

    PubMed

    Camfield, Carol; Camfield, Peter; Smith, Bruce

    2016-11-01

    To explore the influence of several estimates of family socioeconomic status on the long-term clinical course and social outcomes of children with epilepsy. The Nova Scotia childhood epilepsy cohort is population based and includes all children in this Canadian province who developed epilepsy between 1977 and 1985. Eligible patients had ≥10 years of follow-up. Children with childhood absence epilepsy were excluded. Total family income at seizure onset was assessed at seizure onset and classified as "poor" (first quintile), "adequate" (second to third quintiles), and "well-off" (fourth to fifth quintiles). We also assessed parental education and home ownership. Social outcome was assessed in those with normal intelligence who were ≥18 years of age at the end of follow-up using a semistructured interview that explored eight adverse effects. Of 584 patients, 421 (72%) were included. Average follow-up was 26 ± 5.6 years. Overall 137 families (33%) had "poor" income, 159 (38%) had "adequate income," and 125 (30%) were "well-off." Terminal remission of epilepsy occurred in 65% of the poor, 61% of the adequate, and 61% of the well-off (p = ns). Intractable epilepsy, status epilepticus, number of antiepileptic drugs (AEDs) used, and the number of generalized tonic-clonic or focal with secondary generalization seizures through the clinical course was the same in all groups. Home ownership did not predict remission. Neither paternal nor maternal education was associated with remission. Poor children had significantly more adverse social outcomes including failure to graduate from high school, unemployment, personal poverty, inadvertent pregnancy, and psychiatric diagnoses. In Nova Scotia with universal health care, coming from a poor or more affluent family does not seem to affect the clinical course or long-term seizure outcome of childhood epilepsy. Unfortunately children from poor families are less likely to have a good social outcome. Wiley Periodicals, Inc

  11. Clinical Course and Outcomes of Small Supratentorial Intracerebral Hematomas.

    PubMed

    Behrouz, Réza; Misra, Vivek; Godoy, Daniel A; Topel, Christopher H; Masotti, Luca; Klijn, Catharina J M; Smith, Craig J; Parry-Jones, Adrian R; Slevin, Mark A; Silver, Brian; Willey, Joshua Z; Masjuán Vallejo, Jaime; Nzwalo, Hipólito; Popa-Wagner, Aurel; Malek, Ali R; Hafeez, Shaheryar; Di Napoli, Mario

    2017-06-01

    Intracerebral hemorrhage (ICH) volume, particularly if ≥30 mL, is a major determinant of poor outcome. We used a multinational ICH data registry to study the characteristics, course, and outcomes of supratentorial hematomas with volumes <30 mL. Basic characteristics, clinical and radiological course, and 30-day outcomes of these patients were recorded. Outcomes were categorized as early neurological deterioration (END), hematoma expansion, Glasgow Outcome Scale (GOS), and in-hospital death. Poor outcome was defined as composite of in-hospital death and severe disability (GOS ≤ 3). Comparison was conducted based on hemorrhage location. Logistic regression using dichotomized outcome scales was applied to determine predictors of poor outcome. Among 375 cases of supratentorial ICH with volumes <30 mL, expansion and END rates were 19.2% and 7.5%, respectively. Hemorrhage growth was independently associated with END (odds ratio: 28.7, 95% confidence interval [CI]: 8.51-96.5; P < .0001). Expansion rates did not differ according to ICH location. Overall, 13.9% (exact binomial 95% CI: 10.5-17.8) died in the hospital and 29.1% (CI: 24.5-34.0) had severe disability at 30 days; there was a cumulative poor outcome rate of 42.9% (CI: 37.9-48.1). Age, admission Glasgow Coma Scale, intraventricular extension, and END were independently associated with poor outcome. There was no difference in poor outcome rates between lobar and deep locations (40.2% versus 43.8%, P = .56). Patients with supratentorial ICH <30 mL have high rates of poor outcome at 30 days, regardless of location. Nearly 1 in 5 hematomas <30 mL expands, leading to END or death. Copyright © 2017 National Stroke Association. Published by Elsevier Inc. All rights reserved.

  12. Cardiovascular self-management support program for preventing cardiovascular complication behaviors and clinical outcomes in the elderly with poorly controlled type 2 diabetes mellitus in Indonesia: A pilot study.

    PubMed

    Hisni, Dayan; Rukmaini, Rukmaini; Saryono, Saryono; Chinnawong, Tippamas; Thaniwattananon, Ploenpit

    2018-03-06

    The aim of the study was to determine the feasibility, and to evaluate the effect of, a cardiovascular self-management support program by applying the 5A's self-management support program on preventing cardiovascular complication behaviors and to assess the clinical outcomes in the elderly with poorly controlled type 2 diabetes mellitus (DM). This pilot study used a quasi-experimental study design. Twelve elderly persons with poorly controlled type 2 DM were assigned into either a control or experimental group, with six participants in each group. The Preventing Cardiovascular Complication Behaviors (PCCB) was measured by the Preventing Cardiovascular Complication Behaviors Questionnaire, while the clinical outcomes were measured by clinical devices that were provided. These measurements were conducted and compared at baseline and 6 weeks after the completion of the program. The self-management support program was a 6 week program with several implementation methods, based on the 5A's self-management support program. The participants who received the cardiovascular self-management support program reported a significant improvement in their PCCB and clinical outcomes, compared to those receiving the usual care. This study revealed that a cardiovascular self-management support program that applies the 5A's self-management support program is feasible for implementation. © 2018 Japan Academy of Nursing Science.

  13. Mood instability is a common feature of mental health disorders and is associated with poor clinical outcomes

    PubMed Central

    Lloyd, Theodore; Jackson, Richard; Ball, Michael; Shetty, Hitesh; Broadbent, Matthew; Geddes, John R; Stewart, Robert; McGuire, Philip; Taylor, Matthew

    2015-01-01

    Objectives Mood instability is a clinically important phenomenon but has received relatively little research attention. The objective of this study was to assess the impact of mood instability on clinical outcomes in a large sample of people receiving secondary mental healthcare. Design Observational study using an anonymised electronic health record case register. Setting South London and Maudsley NHS Trust (SLaM), a large provider of inpatient and community mental healthcare in the UK. Participants 27 704 adults presenting to SLaM between April 2006 and March 2013 with a psychotic, affective or personality disorder. Exposure The presence of mood instability within 1 month of presentation, identified using natural language processing (NLP). Main outcome measures The number of days spent in hospital, frequency of hospital admission, compulsory hospital admission and prescription of antipsychotics or non-antipsychotic mood stabilisers over a 5-year follow-up period. Results Mood instability was documented in 12.1% of people presenting to mental healthcare services. It was most frequently documented in people with bipolar disorder (22.6%), but was common in people with personality disorder (17.8%) and schizophrenia (15.5%). It was associated with a greater number of days spent in hospital (β coefficient 18.5, 95% CI 12.1 to 24.8), greater frequency of hospitalisation (incidence rate ratio 1.95, 1.75 to 2.17), greater likelihood of compulsory admission (OR 2.73, 2.34 to 3.19) and an increased likelihood of prescription of antipsychotics (2.03, 1.75 to 2.35) or non-antipsychotic mood stabilisers (2.07, 1.77 to 2.41). Conclusions Mood instability occurs in a wide range of mental disorders and is not limited to affective disorders. It is generally associated with relatively poor clinical outcomes. These findings suggest that clinicians should screen for mood instability across all common mental health disorders. The data also suggest that targeted interventions for

  14. Chromosome 17 alterations identify good-risk and poor-risk tumors independently of clinical factors in medulloblastoma

    PubMed Central

    McCabe, Martin G.; Bäcklund, L. Magnus; Leong, Hui Sun; Ichimura, Koichi; Collins, V. Peter

    2011-01-01

    Current risk stratification schemas for medulloblastoma, based on combinations of clinical variables and histotype, fail to accurately identify particularly good- and poor-risk tumors. Attempts have been made to improve discriminatory power by combining clinical variables with cytogenetic data. We report here a pooled analysis of all previous reports of chromosomal copy number related to survival data in medulloblastoma. We collated data from previous reports that explicitly quoted survival data and chromosomal copy number in medulloblastoma. We analyzed the relative prognostic significance of currently used clinical risk stratifiers and the chromosomal aberrations previously reported to correlate with survival. In the pooled dataset metastatic disease, incomplete tumor resection and severe anaplasia were associated with poor outcome, while young age at presentation was not prognostically significant. Of the chromosomal variables studied, isolated 17p loss and gain of 1q correlated with poor survival. Gain of 17q without associated loss of 17p showed a trend to improved outcome. The most commonly reported alteration, isodicentric chromosome 17, was not prognostically significant. Sequential multivariate models identified isolated 17p loss, isolated 17q gain, and 1q gain as independent prognostic factors. In a historical dataset, we have identified isolated 17p loss as a marker of poor outcome and 17q gain as a novel putative marker of good prognosis. Biological markers of poor-risk and good-risk tumors will be critical in stratifying treatment in future trials. Our findings should be prospectively validated independently in future clinical studies. PMID:21292688

  15. Does freeze-all policy affect IVF outcomes in poor responders?

    PubMed

    Roque, Matheus; Valle, Marcello; Sampaio, Marcos; Geber, Selmo

    2017-12-27

    To evaluate whether the freeze-all strategy affects in vitro fertilization (IVF) outcomes in poor ovarian responders following the Bologna criteria. We performed a retrospective cohort study conducted between January 2012 and December 2016. A total of 433 poor responders (per the Bologna criteria) fulfilled the inclusion/exclusion criteria and were included in the study, with 277 patients included in the fresh group and 156 in the freeze-all group. All patients were submitted to controlled ovarian stimulation (COS) with a gonadotropin-releasing hormone antagonist protocol and cleavage-stage embryo transfer (ET). The main outcome measure was ongoing pregnancy rate. Secondary outcomes included implantation and clinical pregnancy rates. The freeze-all strategy was implemented when the progesterone serum level was >1.5 ng/mL on the trigger day, when the endometrium was <7 mm on the trigger day, or as a patient preference. Patients with previous failed fresh embryo transfer were also submitted to fresh or freeze-all strategy considering the indications mentioned above. The patients' mean age in the freeze-all group was 39.5±3.6 years, while that of patients in the fresh group was 39.7±3.8 years (P=0.54). The mean number of embryos transferred (nET) was 1.53±0.6 and 1.60±0.6 (P=0.12) in the freeze-all and fresh groups, respectively. Ongoing pregnancy rates did not significantly differ between the freeze-all and fresh groups (9.6% versus 10.1%, respectively; Relative Risk [RR]: 0.95; 95% CI: 0.52-1.73), nor did the clinical pregnancy rates (14.1% versus 13.7%, respectively; RR: 1.03; 95% CI: 0.63-1.76). Implantation rates were 9.6% and 9.8% (P=0.82) in the freeze-all and fresh groups, respectively. The logistic regression analysis (including age, antral follicle count [AFC], the number of retrieved oocytes, the number of mature oocytes, nET, and fresh versus freeze-all strategy) indicated that age (P<0.001) and the nET (P=0.039) were the only independent variables

  16. Black Hole Sign Predicts Poor Outcome in Patients with Intracerebral Hemorrhage.

    PubMed

    Li, Qi; Yang, Wen-Song; Chen, Sheng-Li; Lv, Fu-Rong; Lv, Fa-Jin; Hu, Xi; Zhu, Dan; Cao, Du; Wang, Xing-Chen; Li, Rui; Yuan, Liang; Qin, Xin-Yue; Xie, Peng

    2018-01-01

    In spontaneous intracerebral hemorrhage (ICH), black hole sign has been proposed as a promising imaging marker that predicts hematoma expansion in patients with ICH. The aim of our study was to investigate whether admission CT black hole sign predicts hematoma growth in patients with ICH. From July 2011 till February 2016, patients with spontaneous ICH who underwent baseline CT scan within 6 h of symptoms onset and follow-up CT scan were recruited into the study. The presence of black hole sign on admission non-enhanced CT was independently assessed by 2 readers. The functional outcome was assessed using the modified Rankin Scale (mRS) at 90 days. Univariate and multivariable logistic regression analyses were performed to assess the association between the presence of the black hole sign and functional outcome. A total of 225 patients (67.6% male, mean age 60.3 years) were included in our study. Black hole sign was identified in 32 of 225 (14.2%) patients on admission CT scan. The multivariate logistic regression analysis demonstrated that age, intraventricular hemorrhage, baseline ICH volume, admission Glasgow Coma Scale score, and presence of black hole sign on baseline CT independently predict poor functional outcome at 90 days. There are significantly more patients with a poor functional outcome (defined as mRS ≥4) among patients with black hole sign than those without (84.4 vs. 32.1%, p < 0.001; OR 8.19, p = 0.001). The CT black hole sign independently predicts poor outcome in patients with ICH. Early identification of black hole sign is useful in prognostic stratification and may serve as a potential therapeutic target for anti-expansion clinical trials. © 2018 S. Karger AG, Basel.

  17. ABCA Transporter Gene Expression and Poor Outcome in Epithelial Ovarian Cancer

    PubMed Central

    Hedditch, Ellen L.; Gao, Bo; Russell, Amanda J.; Lu, Yi; Emmanuel, Catherine; Beesley, Jonathan; Johnatty, Sharon E.; Chen, Xiaoqing; Harnett, Paul; George, Joshy; Williams, Rebekka T.; Flemming, Claudia; Lambrechts, Diether; Despierre, Evelyn; Lambrechts, Sandrina; Vergote, Ignace; Karlan, Beth; Lester, Jenny; Orsulic, Sandra; Walsh, Christine; Fasching, Peter; Beckmann, Matthias W.; Ekici, Arif B.; Hein, Alexander; Matsuo, Keitaro; Hosono, Satoyo; Nakanishi, Toru; Yatabe, Yasushi; Pejovic, Tanja; Bean, Yukie; Heitz, Florian; Harter, Philipp; du Bois, Andreas; Schwaab, Ira; Hogdall, Estrid; Kjaer, Susan K.; Jensen, Allan; Hogdall, Claus; Lundvall, Lene; Engelholm, Svend Aage; Brown, Bob; Flanagan, James; Metcalf, Michelle D; Siddiqui, Nadeem; Sellers, Thomas; Fridley, Brooke; Cunningham, Julie; Schildkraut, Joellen; Iversen, Ed; Weber, Rachel P.; Berchuck, Andrew; Goode, Ellen; Bowtell, David D.; Chenevix-Trench, Georgia; deFazio, Anna; Norris, Murray D.; MacGregor, Stuart; Haber, Michelle; Henderson, Michelle J.

    2014-01-01

    Background ATP-binding cassette (ABC) transporters play various roles in cancer biology and drug resistance, but their association with outcomes in serous epithelial ovarian cancer (EOC) is unknown. Methods The relationship between clinical outcomes and ABC transporter gene expression in two independent cohorts of high-grade serous EOC tumors was assessed with real-time quantitative polymerase chain reaction, analysis of expression microarray data, and immunohistochemistry. Associations between clinical outcomes and ABCA transporter gene single nucleotide polymorphisms were tested in a genome-wide association study. Impact of short interfering RNA–mediated gene suppression was determined by colony forming and migration assays. Association with survival was assessed with Kaplan–Meier analysis and log-rank tests. All statistical tests were two-sided. Results Associations with outcome were observed with ABC transporters of the “A” subfamily, but not with multidrug transporters. High-level expression of ABCA1, ABCA6, ABCA8, and ABCA9 in primary tumors was statistically significantly associated with reduced survival in serous ovarian cancer patients. Low levels of ABCA5 and the C-allele of rs536009 were associated with shorter overall survival (hazard ratio for death = 1.50; 95% confidence interval [CI] =1.26 to 1.79; P = 6.5e−6). The combined expression pattern of ABCA1, ABCA5, and either ABCA8 or ABCA9 was associated with particularly poor outcome (mean overall survival in group with adverse ABCA1, ABCA5 and ABCA9 gene expression = 33.2 months, 95% CI = 26.4 to 40.1; vs 55.3 months in the group with favorable ABCA gene expression, 95% CI = 49.8 to 60.8; P = .001), independently of tumor stage or surgical debulking status. Suppression of cholesterol transporter ABCA1 inhibited ovarian cancer cell growth and migration in vitro, and statin treatment reduced ovarian cancer cell migration. Conclusions Expression of ABCA transporters was associated with poor

  18. ABCA transporter gene expression and poor outcome in epithelial ovarian cancer.

    PubMed

    Hedditch, Ellen L; Gao, Bo; Russell, Amanda J; Lu, Yi; Emmanuel, Catherine; Beesley, Jonathan; Johnatty, Sharon E; Chen, Xiaoqing; Harnett, Paul; George, Joshy; Williams, Rebekka T; Flemming, Claudia; Lambrechts, Diether; Despierre, Evelyn; Lambrechts, Sandrina; Vergote, Ignace; Karlan, Beth; Lester, Jenny; Orsulic, Sandra; Walsh, Christine; Fasching, Peter; Beckmann, Matthias W; Ekici, Arif B; Hein, Alexander; Matsuo, Keitaro; Hosono, Satoyo; Nakanishi, Toru; Yatabe, Yasushi; Pejovic, Tanja; Bean, Yukie; Heitz, Florian; Harter, Philipp; du Bois, Andreas; Schwaab, Ira; Hogdall, Estrid; Kjaer, Susan K; Jensen, Allan; Hogdall, Claus; Lundvall, Lene; Engelholm, Svend Aage; Brown, Bob; Flanagan, James; Metcalf, Michelle D; Siddiqui, Nadeem; Sellers, Thomas; Fridley, Brooke; Cunningham, Julie; Schildkraut, Joellen; Iversen, Ed; Weber, Rachel P; Berchuck, Andrew; Goode, Ellen; Bowtell, David D; Chenevix-Trench, Georgia; deFazio, Anna; Norris, Murray D; MacGregor, Stuart; Haber, Michelle; Henderson, Michelle J

    2014-07-01

    ATP-binding cassette (ABC) transporters play various roles in cancer biology and drug resistance, but their association with outcomes in serous epithelial ovarian cancer (EOC) is unknown. The relationship between clinical outcomes and ABC transporter gene expression in two independent cohorts of high-grade serous EOC tumors was assessed with real-time quantitative polymerase chain reaction, analysis of expression microarray data, and immunohistochemistry. Associations between clinical outcomes and ABCA transporter gene single nucleotide polymorphisms were tested in a genome-wide association study. Impact of short interfering RNA-mediated gene suppression was determined by colony forming and migration assays. Association with survival was assessed with Kaplan-Meier analysis and log-rank tests. All statistical tests were two-sided. Associations with outcome were observed with ABC transporters of the "A" subfamily, but not with multidrug transporters. High-level expression of ABCA1, ABCA6, ABCA8, and ABCA9 in primary tumors was statistically significantly associated with reduced survival in serous ovarian cancer patients. Low levels of ABCA5 and the C-allele of rs536009 were associated with shorter overall survival (hazard ratio for death = 1.50; 95% confidence interval [CI] =1.26 to 1.79; P = 6.5e-6). The combined expression pattern of ABCA1, ABCA5, and either ABCA8 or ABCA9 was associated with particularly poor outcome (mean overall survival in group with adverse ABCA1, ABCA5 and ABCA9 gene expression = 33.2 months, 95% CI = 26.4 to 40.1; vs 55.3 months in the group with favorable ABCA gene expression, 95% CI = 49.8 to 60.8; P = .001), independently of tumor stage or surgical debulking status. Suppression of cholesterol transporter ABCA1 inhibited ovarian cancer cell growth and migration in vitro, and statin treatment reduced ovarian cancer cell migration. Expression of ABCA transporters was associated with poor outcome in serous ovarian cancer, implicating lipid

  19. The poor outcome of ischemic stroke in very old people: a cohort study of its determinants.

    PubMed

    Denti, Licia; Scoditti, Umberto; Tonelli, Claudio; Saccavini, Marsilio; Caminiti, Caterina; Valcavi, Rita; Benatti, Mario; Ceda, Gian Paolo

    2010-01-01

    To assess how much of the excess risk of poor outcome from stroke in people aged 80 and older aging per se explains, independent of other prognostic determinants. Cohort, observational. University hospital. One thousand five hundred fifty-five patients with first-ever ischemic stroke consecutively referred to an in-hospital Clinical Pathway program were studied. The relationship between age and 1-month outcome (death, disability (modified Rankin Scale 3-5), and poor outcome (modified Rankin Scale 3-6)) was assessed, with adjustment for several prognostic factors. Six hundred twelve patients aged 80 and older showed worse outcome after 1 month than those who were younger, in terms of mortality (19% vs 5%, hazard ratio (HR)=3.85, 95% confidence interval (CI)=2.8-5.4) and disability (51% vs 33%, odds ratio (OR)=3.16, 95% CI=2.5-4.0), although in multivariate models, the adjusted HR for mortality decreased to 1.47 (95% CI=1.0-2.16) and the ORs for disability and poor outcome decreased to 1.76 (95% CI=1.32-2.3.) and 1.83 (95% CI=137-2.43), respectively. Stroke severity, the occurrence of at least one medical complication, and premorbid disability explained most of the risk excess in the oldest-old. Stroke outcome is definitely worse in very old people, and most of the excess risk of death and disability is attributable to the higher occurrences of the most-severe clinical stroke syndromes and of medical complications in the acute phase. These represent potential targets for preventive and therapeutical strategies specifically for elderly people.

  20. Prediction of poor outcomes six months following total knee arthroplasty in patients awaiting surgery.

    PubMed

    Lungu, Eugen; Desmeules, François; Dionne, Clermont E; Belzile, Etienne L; Vendittoli, Pascal-André

    2014-09-08

    Identification of patients experiencing poor outcomes following total knee arthroplasty (TKA) before the intervention could allow better case selection, patient preparation and, likely, improved outcomes. The objective was to develop a preliminary prediction rule (PR) to identify patients enrolled on surgical wait lists who are at the greatest risk of poor outcomes 6 months after TKA. 141 patients scheduled for TKA were recruited prospectively from the wait lists of 3 hospitals in Quebec City, Canada. Knee pain, stiffness and function were measured 6 months after TKA with the Western Ontario and McMaster Osteoarthritis Index (WOMAC) and participants in the lowest quintile for the WOMAC total score were considered to have a poor outcome. Several variables measured at enrolment on the wait lists (baseline) were considered potential predictors: demographic, socioeconomic, psychosocial, and clinical factors including pain, stiffness and functional status measured with the WOMAC. The prediction rule was built with recursive partitioning. The best prediction was provided by 5 items of the baseline WOMAC. The rule had a sensitivity of 82.1% (95% CI: 66.7-95.8), a specificity of 71.7% (95% CI: 62.8-79.8), a positive predictive value of 41.8% (95% CI: 29.7-55.0), a negative predictive value of 94.2% (95% CI: 87.1-97.5) and positive and negative likelihood ratios of 2.9 (95% CI: 1.8-4.7) and 0.3 (95% CI: 0.1-0.6) respectively. The developed PR is a promising tool to identify patients at risk of worse outcomes 6 months after TKA as it could help improve the management of these patients. Further validation of this rule is however warranted before clinical use.

  1. Developing from child to adult: Risk factors for poor psychosocial outcome in adolescents and young adults with epilepsy.

    PubMed

    Geerlings, R P J; Aldenkamp, A P; Gottmer-Welschen, L M C; de With, P H N; Zinger, S; van Staa, A L; de Louw, A J A

    2015-10-01

    Childhood-onset epilepsy during the years of transition to adulthood may affect normal social, physical, and mental development, frequently leading to psychosocial and health-related problems in the long term. This study aimed to describe the main characteristics of patients in transition and to identify risk factors for poor psychosocial outcome in adolescents and young adults with epilepsy. Patients with epilepsy, 15-25years of age, who visited the Kempenhaeghe Epilepsy Transition Clinic from March 2012 to December 2014 were included (n=138). Predefined risk scores for medical, educational/occupational status, and independence/separation/identity were obtained, along with individual risk profile scores for poor psychosocial outcome. Multivariate linear regression analysis and discriminant analysis were used to identify variables associated with an increased risk of poor long-term psychosocial outcome. Demographic, epilepsy-related, and psychosocial variables associated with a high risk of poor long-term outcome were lower intelligence, higher seizure frequency, ongoing seizures, and an unsupportive and unstable family environment. Using the aforementioned factors in combination, we were able to correctly classify the majority (55.1%) of the patients regarding their risk of poor psychosocial outcome. Our analysis may allow early identification of patients at high risk of prevention, preferably at pretransition age. The combination of a chronic refractory epilepsy and an unstable family environment constitutes a higher risk of transition problems and poor outcome in adulthood. As a consequence, early interventions should be put into place to protect youth at risk of poor transition outcome. Copyright © 2015 Elsevier Inc. All rights reserved.

  2. Ketones and lactate increase cancer cell “stemness”, driving recurrence, metastasis and poor clinical outcome in breast cancer

    PubMed Central

    Tsirigos, Aristotelis; Lin, Zhao; Pavlides, Stephanos; Wang, Chengwang; Flomenberg, Neal; Knudsen, Erik S; Howell, Anthony; Pestell, Richard G

    2011-01-01

    Previously, we showed that high-energy metabolites (lactate and ketones) “fuel” tumor growth and experimental metastasis in an in vivo xenograft model, most likely by driving oxidative mitochondrial metabolism in breast cancer cells. To mechanistically understand how these metabolites affect tumor cell behavior, here we used genome-wide transcriptional profiling. Human breast cancer cells (MCF7) were cultured with lactate or ketones, and then subjected to transcriptional analysis (exon-array). Interestingly, our results show that treatment with these high-energy metabolites increases the transcriptional expression of gene profiles normally associated with “stemness”, including genes upregulated in embryonic stem (ES) cells. Similarly, we observe that lactate and ketones promote the growth of bonafide ES cells, providing functional validation. The lactate- and ketone-induced “gene signatures” were able to predict poor clinical outcome (including recurrence and metastasis) in human breast cancer patients. Taken together, our results are consistent with the idea that lactate and ketone utilization in cancer cells promotes the “cancer stem cell” phenotype, resulting in significant decreases in patient survival. One possible mechanism by which high-energy metabolites might induce stemness is by increasing the pool of Acetyl-CoA, leading to increased histone acetylation and elevated gene expression. Thus, our results mechanistically imply that clinical outcome in breast cancer could simply be determined by epigenetics and energy metabolism, rather than by the accumulation of specific “classical” gene mutations. We also suggest that high-risk cancer patients (identified by the lactate/ketone gene signatures) could be treated with new therapeutics that target oxidative mitochondrial metabolism, such as the anti-oxidant and “mitochondrial poison” metformin. Finally, we propose that this new approach to personalized cancer medicine be termed

  3. Early Elevation of Serum TNFα is Associated with Poor Outcome in Subarachnoid Hemorrhage

    PubMed Central

    Chou, Sherry HY.; Feske, Steven K.; Atherton, Juli; Konigsberg, Rachael G.; De Jager, Philip L.; Du, Rose; Lo, Eng H.; Ning, MingMing

    2013-01-01

    Objective Subarachnoid hemorrhage (SAH) is associated with inflammation which may mediate poor outcome in SAH. We hypothesize that elevated serum tumor necrosis factor-alpha (TNFα) and interleukin-6 (IL-6) are associated with vasospasm and poor outcome in SAH. Methods In 52 consecutive SAH subjects, we compared TNFα and IL-6 levels on post-SAH days 0–1, 2–3, 4–5, 6–8, and 10–14 with respect to vasospasm and to poor outcome at 3- and 6-months. Vasospasm was defined as >50% reduction in vessel caliber on angiography. Poor outcome was defined as modified Rankin score >2. Results Elevated TNFα on post-SAH days 2–3 was associated with poor 3-month outcome (p=0.0004). Global elevation of TNFα over time (post-SAH days 0–14) was independently associated with poor 3-month outcome after adjusting for Hunt-and-Hess grade and age (p=0.02). Neither cross-sectional nor IL-6 levels over time were associated with outcome. Neither TNFα nor IL-6 levels were associated with vasospasm. Conclusions Elevation in serum TNFα on post-SAH days 2–3 and global elevation of TNFα over time are associated with poor outcome but not with angiographic vasospasm in this small cohort. Future studies are needed to define the role of TNFα in SAH-related brain injury and its potential as a SAH outcome biomarker. PMID:22918199

  4. Predictors of poor treatment outcomes in multidrug-resistant tuberculosis patients: a retrospective cohort study.

    PubMed

    Javaid, A; Ullah, I; Masud, H; Basit, A; Ahmad, W; Butt, Z A; Qasim, M

    2018-06-01

    We aimed to determine the characteristics, treatment outcomes and risk factors for poor treatment outcomes among multidrug-resistant (MDR) tuberculosis (TB) patients in Khyber Pakhtunkhwa province, Pakistan. A retrospective cohort study including all patients with MDR-TB who sought care at the MDR-TB unit in Peshawar was conducted between January 2012 and April 2014. Patients were followed until an outcome of TB treatment was recorded as successful (cured or completed) or unsuccessful. Binary logistic regression was used to identify predictors of poor outcome, i.e. unsuccessful treatment outcomes. Overall, 535 patients were included. The proportion of female subjects was relatively higher (n = 300, 56.1%) than male subjects. The mean (standard deviation) age of patients was 30.37 (14.09) years. Of 535 patients for whom treatment outcomes were available, 402 (75.1%) were cured, 4 (0.7%) completed therapy, 34 (6.4%) had disease that failed to respond to therapy, 93 (17.4%) died and two (0.4%) defaulted; in total, 129 (24.1%) had an unsuccessful outcome. We found three significant predictors of unsuccessful treatment during multivariate logistic regression: being married (odds ratio (OR) = 2.17, 95% confidence interval (CI) 1.01, 4.66), resistance to second-line drugs (OR = 2.61, 95% CI 1.61, 4.21) and presence of extensively drug-resistant TB (OR = 7.82, 95% CI 2.90, 21.07). Approximately 75% of the treatment success rate set by the Global Plan to Stop TB was achieved. Resistance to second-line drugs and presence of extensively drug-resistant TB are the main risk factors for poor treatment outcomes. Copyright © 2017 European Society of Clinical Microbiology and Infectious Diseases. Published by Elsevier Ltd. All rights reserved.

  5. Insulin resistance and clinical outcomes after acute ischemic stroke.

    PubMed

    Ago, Tetsuro; Matsuo, Ryu; Hata, Jun; Wakisaka, Yoshinobu; Kuroda, Junya; Kitazono, Takanari; Kamouchi, Masahiro

    2018-04-24

    In this study, we aimed to determine whether insulin resistance is associated with clinical outcomes after acute ischemic stroke. We enrolled 4,655 patients with acute ischemic stroke (aged 70.3 ± 12.5 years, 63.5% men) who had been independent before admission; were hospitalized in 7 stroke centers in Fukuoka, Japan, from April 2009 to March 2015; and received no insulin therapy during hospitalization. The homeostasis model assessment of insulin resistance (HOMA-IR) score was calculated using fasting blood glucose and insulin levels measured 8.3 ± 7.8 days after onset. Study outcomes were neurologic improvement (≥4-point decrease in NIH Stroke Scale score or 0 at discharge), poor functional outcome (modified Rankin Scale score of ≥3 at 3 months), and 3-month prognosis (stroke recurrence and all-cause mortality). Logistic regression analysis was used to evaluate the association of the HOMA-IR score with clinical outcomes. The HOMA-IR score was associated with neurologic improvement (odds ratio, 0.68 [95% confidence interval, 0.56-0.83], top vs bottom quintile) and with poor functional outcome (2.02 [1.52-2.68], top vs bottom quintile) after adjusting for potential confounding factors, including diabetes and body mass index. HOMA-IR was not associated with stroke recurrence or mortality within 3 months of onset. The associations were maintained in nondiabetic or nonobese patients. No heterogeneity was observed according to age, sex, stroke subtype, or stroke severity. These findings suggest that insulin resistance is independently associated with poor functional outcome after acute ischemic stroke apart from the risk of short-term stroke recurrence or mortality. © 2018 American Academy of Neurology.

  6. Outcome scores in spinal surgery quantified: excellent, good, fair and poor in terms of patient-completed tools.

    PubMed

    Tafazal, Suhayl I; Sell, Philip J

    2006-11-01

    Outcome scores are very useful tools in the field of spinal surgery as they allow us to assess a patient's progress and the effect of various treatments. The clinical importance of a score change is not so clear. Although previous studies have looked at the minimum clinically important score change, the degree of score change varies considerably. Our study is a prospective cohort study of 193 patients undergoing discectomy, decompression and fusion procedures with minimum 2-year follow-up. We have used three standard outcome measures in common usage, the oswestry disability index (ODI), the low back outcome score (LBOS) and the visual analogue score (VAS). We have defined each of these scores according to a global measure of outcome graded by the patient as excellent, good, fair or poor. We have also graded patient perception and classified excellent and good as success and fair and poor as failure. Our results suggest that a median 24-point change in the ODI equates with a good outcome or is the minimum change needed for success. We have also found that different surgical disorders have very different minimal clinically important differences as perceived by patient perception. We found that for a discectomy a minimum 27-point change in the ODI would be classed as a success, for a decompression the change in ODI needed to class it as a success would be 16 points, whereas for a fusion the change in the ODI would be only 13 points. We believe that patient-rated global measures of outcome are of value and we have quantified them in terms of the standard outcome measures used in spinal surgery.

  7. High glucose variability is associated with poor neurodevelopmental outcomes in neonatal hypoxic ischemic encephalopathy.

    PubMed

    Al Shafouri, N; Narvey, M; Srinivasan, G; Vallance, J; Hansen, G

    2015-01-01

    In neonatal hypoxic ischemic encephalopathy (HIE), hypo- and hyperglycemia have been associated with poor outcomes. However, glucose variability has not been reported in this population. To examine the association between serum glucose variability within the first 24 hours and two-year neurodevelopmental outcomes in neonates cooled for HIE. In this retrospective cohort study, glucose, clinical and demographic data were documented from 23 term newborns treated with whole body therapeutic hypothermia. Severe neurodevelopmental outcomes from planned two-year assessments were defined as the presence of any one of the following: Gross Motor Function Classification System levels 3 to 5, Bayley III Motor Standard Score <70, Bayley III Language Score <70 and Bayley III Cognitive Standard Score <70. The neurodevelopmental outcomes from 8 of 23 patients were considered severe, and this group demonstrated a significant increase of mean absolute glucose (MAG) change (-0.28 to -0.03, 95% CI, p = 0.032). There were no significant differences between outcome groups with regards to number of patients with hyperglycemic means, one or multiple hypo- or hyperglycemic measurement(s). There were also no differences between both groups with mean glucose, although mean glucose standard deviation was approaching significance. Poor neurodevelopmental outcomes in whole body cooled HIE neonates are significantly associated with MAG changes. This information may be relevant for prognostication and potential management strategies.

  8. Breast cancers with EGFR and HER2 co-amplification favor distant metastasis and poor clinical outcome

    PubMed Central

    Guo, Peng; Pu, Tianjie; Chen, Shinan; Qiu, Yan; Zhong, Xiaorong; Zheng, Hong; Chen, Lina; Bu, Hong; Ye, Feng

    2017-01-01

    ErbB signaling serves essential roles in invasive ductal carcinoma (IDC). The aim of the present study was to assess gene amplification in ErbB family members in IDC with clinical implications. Quantitative polymerase chain reaction and fluorescence in situ hybridization were performed on formalin-fixed paraffin-embedded tumor samples for gene amplification detection. The clinical and histopathological characteristics, as well as the prognostic significance, were analyzed. Among the 119 IDC patients evaluated, epidermal growth factor receptor [EGFR; also known as human epidermal growth factor receptor (HER)1], HER2, HER3 and HER4 gene amplification was observed in 30 (25.2%), 44 (36.9%), 0 (0.0%) and 1 (0.8%) patients, respectively. EGFR amplification was associated with estrogen receptor status (P=0.028) and higher possibilities of recurrence (P=0.015) and distant metastasis (following initial surgery) (P=0.011). In survival analysis, EGFR amplification was also associated with disease-free survival (DFS) (P=0.001) and overall survival (OS) (P=0.003). HER2 amplification was associated with larger tumor size (P=0.006), later clinical stage (P=0.003) and distant metastasis (following initial surgery) (P=0.006). In survival analysis, HER2 amplification was also associated with DFS (P=0.011). Notably, the present study identified a group of patients in whom EGFR and HER2 were co-amplified. This group of patients appeared to have a higher possibility of metastasis (when diagnosed) (P=0.014) and distant metastasis (following initial surgery) (P<0.001). In survival analysis, these patients were noticed to be associated with DFS (P<0.001) and OS (P=0.002). With respect to treatment regimen, this was also true for the DFS association with chemotherapy (P<0.001), radiotherapy (P<0.001) and hormonal therapy (P=0.001). The present results suggest that EGFR and HER2 amplification favor distant metastasis following initial surgery and are significantly associated with poor

  9. Poor oral status is associated with rehabilitation outcome in older people.

    PubMed

    Shiraishi, Ai; Yoshimura, Yoshihiro; Wakabayashi, Hidetaka; Tsuji, Yuri

    2017-04-01

    Poor oral status is associated with increased physical dependency and cognitive decline. Malnutrition, a potential result of poor oral status, is associated with poorer rehabilitation outcome and physical function. However, the association between oral status and rehabilitation outcome is not fully understood. The present study investigated the association of poor oral status with rehabilitation outcome in older patients. A retrospective cohort study was carried out of 108 consecutive patients (mean age 80.5 ± 6.8 years; 50.9% men) who were admitted to convalescent rehabilitation wards. The Revised Oral Assessment Guide was used to evaluate oral status. Rehabilitation outcome was evaluated by the Functional Independence Measure (FIM) on discharge. Multivariate analyses were applied to examine the associations between poor oral status and motor-FIM on discharge. According to the Revised Oral Assessment Guide score, 14.8% of participants had normal oral status, 52.8% had slight to moderate oral problems and 32.4% had severe oral problems. The median scores of motor-FIM on admission and on discharge were 52 (interquartile range 25-70) and 75 (interquartile range 51-89), respectively. Multivariate analysis showed that the Revised Oral Assessment Guide score and the motor-/cognitive-FIM scores on admission were significant independent factors for motor-FIM on discharge, after adjusted for sex, age, length of stay, nutritional status, handgrip and causative diseases (P < 0.001). Poor oral status is associated with rehabilitation outcome in older people. Geriatr Gerontol Int 2017; 17: 598-604. © 2016 Japan Geriatrics Society.

  10. Neurophysiological prediction of neurological good and poor outcome in post-anoxic coma.

    PubMed

    Grippo, A; Carrai, R; Scarpino, M; Spalletti, M; Lanzo, G; Cossu, C; Peris, A; Valente, S; Amantini, A

    2017-06-01

    Investigation of the utility of association between electroencephalogram (EEG) and somatosensory-evoked potentials (SEPs) for the prediction of neurological outcome in comatose patients resuscitated after cardiac arrest (CA) treated with therapeutic hypothermia, according to different recording times after CA. Glasgow Coma Scale, EEG and SEPs performed at 12, 24 and 48-72 h after CA were assessed in 200 patients. Outcome was evaluated by Cerebral Performance Category 6 months after CA. Within 12 h after CA, grade 1 EEG predicted good outcome and bilaterally absent (BA) SEPs predicted poor outcome. Because grade 1 EEG and BA-SEPs were never found in the same patient, the recording of both EEG and SEPs allows us to correctly prognosticate a greater number of patients with respect to the use of a single test within 12 h after CA. At 48-72 h after CA, both grade 2 EEG and BA-SEPs predicted poor outcome with FPR=0.0%. When these neurophysiological patterns are both present in the same patient, they confirm and strengthen their prognostic value, but because they also occurred independently in eight patients, poor outcome is predictable in a greater number of patients. The combination of EEG/SEP findings allows prediction of good and poor outcome (within 12 h after CA) and of poor outcome (after 48-72 h). Recording of EEG and SEPs in the same patients allows always an increase in the number of cases correctly classified, and an increase of the reliability of prognostication in a single patient due to concordance of patterns. © 2016 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

  11. Triage of patients with acute gastrointestinal bleeding for intensive care unit admission based on risk factors for poor outcome.

    PubMed

    Afessa, B

    2000-04-01

    This study's aim was to determine the prognostic factors and to develop a triage system for intensive care unit (ICU) admission of patients with gastrointestinal bleeding (GIB). This prospective, observational study included 411 adults consecutively hospitalized for GIB. Each patient's selected clinical findings and laboratory values at presentation were obtained. The Acute Physiology and Chronic Health Evaluation (APACHE) II scores were calculated from the initial findings in the emergency department. Poor outcome was defined as recurrent GIB, emergency surgery, or death. The role of hepatic cirrhosis, APACHE II score, active GIB, end-organ dysfunction, and hypotension in predicting outcome was evaluated. Chi-square, Student's t, Mann-Whitney U, and logistic regression analysis tests were used for statistical comparisons. Poor outcome developed in 81 (20%) patients; 39 died, 23 underwent emergency surgery, and 47 rebled. End-organ dysfunction, active bleeding, hepatic cirrhosis, and high APACHE II scores were independent predictors of poor outcome with odds ratios of 3:1, 3:1, 2:3, and 1:1, respectively. The ICU admission rate was 37%. High APACHE II score, active bleeding, end-organ dysfunction, and hepatic cirrhosis are independent predictors of poor outcome in patients with GIB and can be used in the triage of these patients for ICU admission.

  12. Serum Galectin-3 and Poor Outcomes Among Patients With Acute Ischemic Stroke.

    PubMed

    Wang, Aili; Zhong, Chongke; Zhu, Zhengbao; Xu, Tian; Peng, Yanbo; Xu, Tan; Peng, Hao; Chen, Chung-Shiuan; Wang, Jinchao; Ju, Zhong; Li, Qunwei; Geng, Deqin; Sun, Yingxian; Zhang, Jianhui; Yuan, Xiaodong; Chen, Jing; Zhang, Yonghong; He, Jiang

    2018-01-01

    Elevated galectin-3 has been associated with atherosclerosis and poor outcomes in patients with heart failure. However, it remains unclear whether galectin-3 has any effect on the poor outcomes of ischemic stroke. The aim of the present study was to examine the association between galectin-3 with poor outcomes among patients with acute ischemic stroke. Serum galectin-3 was measured in 3082 patients with acute ischemic stroke. The primary outcome was a combination of death or major disability (modified Rankin Scale score, ≥3) at 3 months after stroke. Compared with the lowest quartile of galectin-3, multivariate adjusted odds ratios (95% confidence intervals) for the highest quartile of galectin-3 were 1.55 (1.15-2.09) for composite outcome, 2.10 (0.89-4.95) for death, and 1.43 (1.05-1.93) for major disability. The addition of galectin-3 to the conventional risk factors significantly improved prediction of the combined outcome of death or major disability in patients with ischemic stroke (net reclassification index, 18.9%; P <0.001; integrated discrimination improvement, 0.4%; P =0.001). Higher levels of serum galectin-3 were independently associated with increased risk of death or major disability after stroke onset, suggesting that galectin-3 may have prognostic value in poor outcomes of ischemic stroke. © 2017 American Heart Association, Inc.

  13. Citrobacter Peritoneal Dialysis Peritonitis: Rare Occurrence with Poor Outcomes

    PubMed Central

    Chao, Chia-Ter; Lee, Szu-Ying; Yang, Wei-Shun; Chen, Huei-Wen; Fang, Cheng-Chung; Yen, Chung-Jen; Chiang, Chih-Kang; Hung, Kuan-Yu; Huang, Jenq-Wen

    2013-01-01

    Introduction: Non-Pseudomonas gram-negative bacteria are responsible for an increasing proportion of cases of peritoneal dialysis (PD)-related peritonitis. The role of Citrobacter species in the etiology of PD-related peritonitis is often underestimated. In the present study, we aimed to describe the clinical features, laboratory findings, and short- and long-term outcomes in PD-related peritonitis caused by Citrobacter. Methods: A retrospective review of all episodes of PD-related peritonitis caused by Citrobacter from a single center between 1990 and 2010 was performed. Clinical features, microbiological data, and outcomes of these episodes were analyzed. Results: Citrobacter species was responsible for 11 PD-related episodes (1.8% of all peritonitis episodes) in 8 patients. Citrobacter freundii was the most common etiologic species (73%), and mixed growth was found in the other 3 episodes (27%). Approximately half (46%) of the episodes were associated with constipation and/or diarrhea. Of the Citrobacter isolates from all episodes, 54% were resistant to cefazolin, and only 18% were susceptible to cefmetazole. All isolates were susceptible to ceftazidime, cefepime, carbapenem, and aminoglycosides. More than half of the patients (54%) were hospitalized for index peritonitis, and 27% of the episodes involved a change in antibiotic medication. One patient had relapsing peritonitis caused by C. koseri (9%). The mortality rate of PD-related peritonitis caused by Citrobacter was 18%, and 89% of surviving patients developed technique failure requiring a modality switch after an average of 12 months of follow-up (range 1.2-31.2 months). Conclusion: PD-related peritonitis caused by Citrobacter is associated with poor outcomes, including high rates of antibiotic resistance, a high mortality rate, and a high rate of technique failure among survivors during the follow-up period. PMID:23869184

  14. Aurora-A overexpression and aneuploidy predict poor outcome in serous ovarian carcinoma.

    PubMed

    Lassus, Heini; Staff, Synnöve; Leminen, Arto; Isola, Jorma; Butzow, Ralf

    2011-01-01

    Aurora-A is a potential oncogene and therapeutic target in ovarian carcinoma. It is involved in mitotic events and overexpression leads to centrosome amplification and chromosomal instability. The objective of this study was to evaluate the clinical significance of Aurora-A and DNA ploidy in serous ovarian carcinoma. Serous ovarian carcinomas were analysed for Aurora-A protein by immunohistochemistry (n=592), Aurora-A copy number by CISH (n=169), Aurora-A mRNA by real-time PCR (n=158) and DNA ploidy by flowcytometry (n=440). Overexpression of Aurora-A was found in 27% of the tumors, cytoplasmic overexpression in 11% and nuclear in 17%. The cytoplasmic and nuclear overexpression were nearly mutually exclusive. Both cytoplasmic and nuclear overexpression were associated with shorter survival, high grade, high proliferation index and aberrant p53. Interestingly, only cytoplasmic expression was associated with aneuploidy and expression of phosphorylated Aurora-A. DNA ploidy was associated with poor patient outcome as well as aggressive clinicopathological parameters. In multivariate analysis, Aurora-A overexpression appeared as an independent prognostic factor for disease-free survival, together with grade, stage and ploidy. Aurora-A protein expression is strongly linked with poor patient outcome and aggressive disease characteristics, which makes Aurora-A a promising biomarker and a potential therapeutic target in ovarian carcinoma. Cytoplasmic and nuclear Aurora-A protein may have different functions. DNA aneuploidy is a strong predictor of poor prognosis in serous ovarian carcinoma. Copyright © 2010 Elsevier Inc. All rights reserved.

  15. Homeostasis model assessment of insulin resistance in relation to the poor functional outcomes in nondiabetic patients with ischemic stroke

    PubMed Central

    Li, Siou; Yin, Changhao; Zhao, Weina; Zhu, Haifu; Xu, Dan; Xu, Qing; Jiao, Yang; Wang, Xue; Qiao, Hong

    2018-01-01

    Whether insulin resistance (IR) predicts worse functional outcome in ischemic stroke is still a matter of debate. The aim of the present study is to determine the association between IR and risk of poor outcome in 173 Chinese nondiabetic patients with acute ischemic stroke. This is a prospective, population-based cohort study. Insulin sensitivity, expressed by the homeostasis model assessment (HOMA) of insulin sensitivity (HOMA index = (fasting insulin × fasting glucose)/22.5). IR was defined by HOMA-IR index in the top quartile (Q4). Functional impairment was evaluated at discharge using the modified Rankin scale (mRS). The median (interquartile range) HOMA-IR was 2.14 (1.17–2.83), and Q4 was at least 2.83. There was a significantly positive correlation between HOMA-IR and National Institutes of Health Stroke Scale (r = 0.408; P<0.001). In multivariate analyses, patients in IR group were associated with a higher risk of poor functional outcome (odds ratio (OR) = 3.23; 95% confidence interval (CI) = 1.75–5.08; P=0.001). In multivariate models comparing the third and fourth quartiles against the first quartile of the HOMA-IR, levels of HOMA-IR were associated with poor outcome, and the adjusted risk of poor outcome increased by 207% (OR = 3.05 (95% CI 1.70–4.89), P=0.006) and 429% (5.29 (3.05–9.80), P<0.001). In a receiver operating characteristic curve (ROC) analysis of poor outcome, the area under the curve (AUC) increased from 0.80 to 0.84 (95% CI: 0.79–0.88) by adding HOMA-IR to clinical examination variables (P=0.02). High HOMA-IR index is associated with a poor functional outcome in nondiabetic patients with acute ischemic stroke. PMID:29588341

  16. Blend sign predicts poor outcome in patients with intracerebral hemorrhage

    PubMed Central

    Cao, Du; Zhu, Dan; Lv, Fa-Jin; Liu, Yang; Yuan, Liang; Zhang, Gang; Xiong, Xin; Li, Rui; Hu, Yun-Xin; Qin, Xin-Yue; Xie, Peng

    2017-01-01

    Introduction Blend sign has been recently described as a novel imaging marker that predicts hematoma expansion. The purpose of our study was to investigate the prognostic value of CT blend sign in patients with ICH. Objectives and methods Patients with intracerebral hemorrhage who underwent baseline CT scan within 6 hours were included. The presence of blend sign on admission nonenhanced CT was independently assessed by two readers. The functional outcome was assessed by using the modified Rankin Scale (mRS) at 90 days. Results Blend sign was identified in 40 of 238 (16.8%) patients on admission CT scan. The proportion of patients with a poor functional outcome was significantly higher in patients with blend sign than those without blend sign (75.0% versus 47.5%, P = 0.001). The multivariate logistic regression analysis demonstrated that age, intraventricular hemorrhage, admission GCS score, baseline hematoma volume and presence of blend sign on baseline CT independently predict poor functional outcome at 90 days. The CT blend sign independently predicts poor outcome in patients with ICH (odds ratio 3.61, 95% confidence interval [1.47–8.89];p = 0.005). Conclusions Early identification of blend sign is useful in prognostic stratification and may serve as a potential therapeutic target for prospective interventional studies. PMID:28829797

  17. Blend sign predicts poor outcome in patients with intracerebral hemorrhage.

    PubMed

    Li, Qi; Yang, Wen-Song; Wang, Xing-Chen; Cao, Du; Zhu, Dan; Lv, Fa-Jin; Liu, Yang; Yuan, Liang; Zhang, Gang; Xiong, Xin; Li, Rui; Hu, Yun-Xin; Qin, Xin-Yue; Xie, Peng

    2017-01-01

    Blend sign has been recently described as a novel imaging marker that predicts hematoma expansion. The purpose of our study was to investigate the prognostic value of CT blend sign in patients with ICH. Patients with intracerebral hemorrhage who underwent baseline CT scan within 6 hours were included. The presence of blend sign on admission nonenhanced CT was independently assessed by two readers. The functional outcome was assessed by using the modified Rankin Scale (mRS) at 90 days. Blend sign was identified in 40 of 238 (16.8%) patients on admission CT scan. The proportion of patients with a poor functional outcome was significantly higher in patients with blend sign than those without blend sign (75.0% versus 47.5%, P = 0.001). The multivariate logistic regression analysis demonstrated that age, intraventricular hemorrhage, admission GCS score, baseline hematoma volume and presence of blend sign on baseline CT independently predict poor functional outcome at 90 days. The CT blend sign independently predicts poor outcome in patients with ICH (odds ratio 3.61, 95% confidence interval [1.47-8.89];p = 0.005). Early identification of blend sign is useful in prognostic stratification and may serve as a potential therapeutic target for prospective interventional studies.

  18. High urinary albumin/creatinine ratio at admission predicts poor functional outcome in patients with acute ischaemic stroke.

    PubMed

    Watanabe, Yoko; Suda, Satoshi; Kanamaru, Takuya; Katsumata, Toshiya; Okubo, Seiji; Kaneko, Tomohiro; Mii, Akiko; Sakai, Yukinao; Katayama, Yasuo; Kimura, Kazumi; Tsuruoka, Shuichi

    2017-03-01

    Albuminuria and a low estimated glomerular filtration rate (eGFR) are widely recognized indices of kidney dysfunction and have been linked to cardiovascular events, including stroke. We evaluated albuminuria, measured using the urinary albumin/creatinine ratio (UACR), and the eGFR in the acute phase of ischaemic stroke, and investigated the clinical characteristics of ischaemic stroke patients with and those without kidney dysfunction. The study included 422 consecutive patients admitted between June 2010 and May 2012. General blood and urine examinations were performed at admission. Kidney dysfunction was defined as a low eGFR (<60 mL/min per 1.73 m 2 ), high albuminuria (≥30 mg/g creatinine), or both. Neurological severity was evaluated using the National Institutes of Health Stroke Scale (NIHSS) at admission and the modified Rankin scale (mRS) at discharge. A poor outcome was defined as a mRS score of 3-5 or death. The impacts of the eGFR and UACR on outcomes at discharge were evaluated using multiple logistic regression analysis. Kidney dysfunction was diagnosed in 278 of the 422 patients (65.9%). The eGFR was significantly lower and UACR was significantly higher in patients with a poor outcome than in those with a good outcome. In multivariate analyses performed after adjusting for confounding factors, UACR >31.2 mg/g creatinine (OR, 2.58; 95% CI, 1.52-4.43; P = 0.0005) was independently associated with a poor outcome, while a low eGFR was not associated. A high UACR at admission may predict a poor outcome at discharge in patients with acute ischaemic stroke. © 2016 Asian Pacific Society of Nephrology.

  19. Risk factors for poor multidrug-resistant tuberculosis treatment outcomes in Kyiv Oblast, Ukraine.

    PubMed

    Aibana, Omowunmi; Bachmaha, Mariya; Krasiuk, Viatcheslav; Rybak, Natasha; Flanigan, Timothy P; Petrenko, Vasyl; Murray, Megan B

    2017-02-07

    Ukraine is among ten countries with the highest burden of multidrug- resistant TB (MDR-TB) worldwide. Treatment success rates for MDR-TB in Ukraine remain below global success rates as reported by the World Health Organization. Few studies have evaluated predictors of poor MDR-TB outcomes in Ukraine. We conducted a retrospective analysis of patients initiated on MDR-TB treatment in the Kyiv Oblast of Ukraine between January 01, 2012 and March 31st, 2015. We defined good treatment outcomes as cure or completion and categorized poor outcomes among those who died, failed treatment or defaulted. We used logistic regression analyses to identify baseline patient characteristics associated with poor MDR-TB treatment outcomes. Among 360 patients, 65 (18.1%) achieved treatment cure or completion while 131 (36.4%) died, 115 (31.9%) defaulted, and 37 (10.3%) failed treatment. In the multivariate analysis, the strongest baseline predictors of poor outcomes were HIV infection without anti-retroviral therapy (ART) initiation (aOR 10.07; 95% CI 1.20-84.45; p 0.03) and presence of extensively-drug resistant TB (aOR 9.19; 95% CI 1.17-72.06; p 0.03). HIV-positive patients initiated on ART were not at increased risk of poor outcomes (aOR 1.43; 95% CI 0.58-3.54; p 0.44). There was no statistically significant difference in risk of poor outcomes among patients who received baseline molecular testing with Gene Xpert compared to those who were not tested (aOR 1.31; 95% CI 0.63-2.73). Rigorous compliance with national guidelines recommending prompt initiation of ART among HIV/TB co-infected patients and use of drug susceptibility testing results to construct treatment regimens can have a major impact on improving MDR-TB treatment outcomes in Ukraine.

  20. Factors associated with poor outcome for aneurysmal subarachnoid haemorrhage in a series of 334 patients.

    PubMed

    Rivero Rodríguez, D; Scherle Matamoros, C; Fernández Cúe, L; Miranda Hernández, J L; Pernas Sánchez, Y; Pérez Nellar, J

    This study evaluates care-related sociodemographic, clinical, and imaging factors and influences associated with outcome at discharge in patients with aneurismal subarachnoid haemorrhage. Retrospective cohort study in 334 patients treated at Hospital Hermanos Ameijeiras in Havana, Cuba between October 2005 and June 2014. Logistic regression analysis determined that the following factors were associated with higher risk of poor outcome: age older than 65 years (OR 3.51, 95% CI 1.79-5.7, P=.031), female sex (OR 2.17, 95% CI 1.22-3.84, P=.0067), systolic hypertension (OR 4.82, 95% CI 2.27-9.8, P=.0001), and hyperglycaemia at admission (OR 3.93, 95% CI 2.10-7.53, P=.0003). Certain complications were also associated with poor prognosis, including respiratory infection (OR 2.73, 95% CI 1.27-5.85, P=.0085), electrolyte disturbances (OR 3.33, 95% CI 1.33-8.28, P=.0073), hydrocephalus (OR 2.21, 95% CI 1.05-4.63, P=.0039), rebleeding (OR 16.50, 95% CI 8.24-41.24, P=.0000), symptomatic vasospasm (OR 19.00, 95% CI 8.86-41.24, P=.0000), cerebral ischaemia (OR 3.82, 95% CI 1.87-7.80, P=.000) and multiplex rebleeding (OR 6.69, 95% CI 1.35-36.39, P=.0019). Grades of iii and iv on the World Federation of Neurological Surgeons (OR 2.09, 95% CI 1.12-3.91, P=.0021) and Fisher scales (OR 5.18, 95% CI 2.65-10.29, P=.0008) were also related to poor outcome. Outcome of aneurysmal subarachnoid haemorrhage was related to age, sex, clinical status at admission to the stroke unit, imaging findings according to the Fisher scale, blood pressure, glycaemia and such complications as electrolyte disturbances, hydrocephalus, rebleeding, and multiplex rebleeding. Copyright © 2014 Sociedad Española de Neurología. Publicado por Elsevier España, S.L.U. All rights reserved.

  1. Reduced Bearing Excursion After Mobile-Bearing Unicompartmental Knee Arthroplasty is Associated With Poor Functional Outcomes.

    PubMed

    Wahal, Naman; Gaba, Sahil; Malhotra, Rajesh; Kumar, Vijay; Pegg, Elise C; Pandit, Hemant

    2018-02-01

    A small proportion of patients with mobile unicompartmental knee arthroplasty (UKA) report poor functional outcomes in spite of optimal component alignment on postoperative radiographs. The purpose of this study is to assess whether there is a correlation between functional outcome and knee kinematics. From a cohort of consecutive cases of 150 Oxford medial UKA, patients with fair/poor functional outcome at 1-year postsurgery (Oxford Knee Score [OKS] < 34, n = 15) were identified and matched for age, gender, preoperative clinical scores, and follow-up period with a cohort of patients with good/excellent outcome (OKS ≥ 34, n = 15). In vivo kinematic assessment was performed using step-up and deep knee bend exercises under fluoroscopic imaging. The fluoroscopic videos were analyzed using MATLAB software to measure the variation in time taken to complete the exercises, patellar tendon angle, and bearing position with knee flexion angle. Mean OKS in the fair/poor group was 29.9 and the mean OKS in the good/excellent group was 41.1. The tibial slope, time taken to complete the exercises, and patellar tendon angle trend over the flexion range were similar in both the groups; however, bearing position and the extent of bearing excursion differed significantly. The total bearing excursion in the OKS < 34 group was significantly smaller than the OKS ≥ 34 group (35%). Furthermore, on average, the bearing was positioned 1.7 mm more posterior on the tibia in the OKS < 34 group. This study provides evidence that abnormal knee kinematics, in particular bearing excursion and positioning, are associated with worse functional outcomes after mobile UKA. Copyright © 2017 Elsevier Inc. All rights reserved.

  2. Clinical outcomes of neonatal onset proximal versus distal urea cycle disorders do not differ.

    PubMed

    Ah Mew, Nicholas; Krivitzky, Lauren; McCarter, Robert; Batshaw, Mark; Tuchman, Mendel

    2013-02-01

    To compare the clinical course and outcome of patients diagnosed with one of 4 neonatal-onset urea cycle disorders (UCDs): deficiency of carbamyl phosphate synthase 1 (CPSD), ornithine transcarbamylase (OTCD), argininosuccinate synthase (ASD), or argininosuccinate lyase (ALD). Clinical, biochemical, and neuropsychological data from 103 subjects with neonatal-onset UCDs were derived from the Longitudinal Study of Urea Cycle Disorders, an observational protocol of the Urea Cycle Disorders Consortium, one of the Rare Disease Clinical Research Networks. Some 88% of the subjects presented clinically by age 7 days. Peak ammonia level was 963 μM in patients with proximal UCDs (CPSD or OTCD), compared with 589 μM in ASD and 573 μM in ALD. Roughly 25% of subjects with CPSD or OTCD, 18% of those with ASD, and 67% of those with ALD had a "honeymoon period," defined as the time interval from discharge from initial admission to subsequent admission for hyperammonemia, greater than 1 year. The proportion of patients with a poor outcome (IQ/Developmental Quotient <70) was greatest in ALD (68%), followed by ASD (54%) and CPSD/OTCD (47%). This trend was not significant, but was observed in both patients aged <4 years and those aged ≥ 4 years. Poor cognitive outcome was not correlated with peak ammonia level or duration of initial admission. Neurocognitive outcomes do not differ between patients with proximal UCDs and those with distal UCDs. Factors other than hyperammonemia may contribute to poor neurocognitive outcome in the distal UCDs. Copyright © 2013 Mosby, Inc. All rights reserved.

  3. Clinical outcomes and survival in AA amyloidosis patients.

    PubMed

    Ayar, Yavuz; Ersoy, Alparslan; Oksuz, Mustafa Ferhat; Ocakoglu, Gokhan; Vuruskan, Berna Aytac; Yildiz, Abdülmecit; Isiktas, Emel; Oruc, Aysegül; Celikci, Sedat; Arslan, Ismail; Sahin, Ahmet Bilgehan; Güllülü, Mustafa

    Amyloid A amyloidosis is a rare complication of chronic inflammatory conditions. Most patients with amyloid A amyloidosis present with nephropathy and it leads to renal failure and death. We studied clinical characteristics and survival in patients with amyloid A amyloidosis. A total of 81 patients (51 males, 30 females) with renal biopsy proven amyloid A amyloidosis were analyzed retrospectively. The patients were divided into good and poor outcomes groups according to survival results. Most of the patients (55.6%) had nephrotic range proteinuria at diagnosis. Most frequent underlying disorders were familial Mediterranean fever (21.2%) and rheumatoid arthritis (10.6%) in the good outcome group and malignancy (20%) in the poor outcome group. Only diastolic blood pressure in the good outcome group and phosphorus level in the poor outcome group was higher. Serum creatinine levels increased after treatment in both groups, while proteinuria in the good outcome group decreased. Increase in serum creatinine and decrease in estimated glomerular filtration rate of the poor outcome group were more significant in the good outcome group. At the time of diagnosis 18.5% and 27.2% of all patients had advanced chronic kidney disease (stage 4 and 5, respectively). Median duration of renal survival was 65±3.54 months. Among all patients, 27.1% were started dialysis treatment during the follow-up period and 7.4% of all patients underwent kidney transplantation. Higher levels of systolic blood pressure [hazard ratios 1.03, 95% confidence interval: 1-1.06, p=0.036], serum creatinine (hazard ratios 1.25, 95% confidence interval: 1.07-1.46, p=0.006) and urinary protein excretion (hazard ratios 1.08, 95% confidence interval: 1.01-1.16, p=0.027) were predictors of end-stage renal disease. Median survival of patients with organ involvement was 50.3±16 months. Our study indicated that familial Mediterranean fever constituted a large proportion of cases and increased number of patients

  4. Integrated genomic analyses identify KDM1A's role in cell proliferation via modulating E2F signaling activity and associate with poor clinical outcome in oral cancer.

    PubMed

    Narayanan, Sathiya Pandi; Singh, Smriti; Gupta, Amit; Yadav, Sandhya; Singh, Shree Ram; Shukla, Sanjeev

    2015-10-28

    The histone demethylase KDM1A specifically demethylates lysine residues and its deregulation has been implicated in the initiation and progression of various cancers. However, KDM1A's molecular role and its pathological consequences, and prognostic significance in oral cancer remain less understood. In the present study, we sought to investigate the expression of KDM1A and its downstream role in oral cancer pathogenesis. By comparing mRNA expression profiles, we identified an elevated KDM1A expression in oral tumors when compared to normal oral tissues. In silico pathway prediction identified the association between KDM1A and E2F1 signaling in oral cancer. Pathway scanning, functional annotation analysis and In vitro assays showed the KDM1A's involvement in oral cancer cell proliferation and the cell cycle. Moreover, real time PCR and luciferase assays confirmed KDM1A's role in regulation of E2F1 signaling activity in oral cancer. Elevated KDM1A expression is associated with poor clinical outcome in oral cancer. Our data indicate that deregulated KDM1A expression is positively associated with proliferative phenotype of oral cancer and confers poor clinical outcome. These cumulative data suggest that KDM1A might be a potential diagnostic and therapeutic target for oral cancer. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

  5. Independent Factors for Prediction of Poor Outcomes in Patients with Febrile Neutropenia

    PubMed Central

    Günalp, Müge; Koyunoğlu, Merve; Gürler, Serdar; Koca, Ayça; Yeşilkaya, İlker; Öner, Emre; Akkaş, Meltem; Aksu, Nalan Metin; Demirkan, Arda; Polat, Onur; Elhan, Atilla Halil

    2014-01-01

    Background Febrile neutropenia (FN) is a life-threatening condition that requires urgent management in the emergency department (ED). Recent progress in the treatment of neutropenic fever has underscored the importance of risk stratification. In this study, we aimed to determine independent factors for prediction of poor outcomes in patients with FN. Material/Methods We retrospectively evaluated 200 chemotherapy-induced febrile neutropenic patients who visited the ED. Upon arrival at the ED, clinical data, including sex, age, vital signs, underlying systemic diseases, laboratory test results, estimated GFR, blood cultures, CRP, radiologic examinations, and Multinational Association of Supportive Care in Cancer (MASCC) score of all febrile neutropenic patients were obtained. Outcomes were categorized as “poor” if serious complications during hospitalization, including death, occurred. Results The platelet count <50 000 cells/mm3 (OR 3.90, 95% CI 1.62–9.43), pulmonary infiltration (OR 3.45, 95% CI 1.48–8.07), hypoproteinemia <6 g/dl (OR 3.30, 95% CI 1.27–8.56), respiratory rate >24/min (OR 8.75, 95% CI 2.18–35.13), and MASCC score <21 (OR 9.20, 95% CI 3.98–21.26) were determined as independent risk factors for the prediction of death. The platelet count <50 000 cells/mm3 (OR 3.93, 95% CI 1.42–10.92), serum CRP >50 mg/dl (OR 3.80, 95% CI 1.68–8.61), hypoproteinemia (OR 7.81, 95% CI 3.43–17.78), eGFR ≤90 ML/min/1.73 m2 (OR 3.06, 95% CI 1.13–8.26), and MASCC score <21 (OR 3.45, 95% CI 1.53–7.79) were determined as independent risk factors for the prediction of poor clinical outcomes of FN patients. Platelet count, protein level, respiratory rate, pulmonary infiltration, CRP, MASCC score, and eGFR were shown to have a significant association with outcome. Conclusions The results of our study may help emergency medicine physicians to prevent serious complications with proper use of simple independent risk factors besides MASCC score. PMID

  6. IVF outcomes in average- and poor-prognosis infertile women according to the number of embryos transferred.

    PubMed

    Vega, Mario G; Gleicher, Norbert; Darmon, Sarah K; Weghofer, Andrea; Wu, Yan-Guang; Wang, Qi; Zhang, Lin; Albertini, David F; Barad, David H; Kushnir, Vitaly A

    2016-09-01

    Outcome measures of IVF success, which account for effectiveness of IVF and perinatal outcome risks, have recently been described. The association between number of embryos transferred in average and poor-prognosis IVF patients, and the chances of having good or poor IVF and perinatal outcomes, was investigated. Good IVF and perinatal outcome was defined as the birth of a live, term, normal-weight infant (≥2500 g). Poor IVF and perinatal outcome was defined as no live birth or birth of a very low weight neonate (<1500 g) or severe prematurity (birth at <32 weeks gestation). Each neonate was analysed as a separate outcome. A total of 713 IVF cycles in 504 average and poor-prognosis patients from January 2010 to December 2013 were identified. The odds of having good IVF and perinatal outcomes increased by 28% for each additional embryo transferred. The odds of poor IVF and perinatal outcome decreased by 32% with an additional embryo transferred. The likelihood of live birth with good perinatal outcome in average- and poor-prognosis patients after IVF increases with additional embryos being transferred. These data add to recently reported evidence in favour of multiple embryo transfer in older women and those with average or poor IVF prognosis. Copyright © 2016 Reproductive Healthcare Ltd. Published by Elsevier Ltd. All rights reserved.

  7. Risk factors for poor outcomes in patients with open-globe injuries

    PubMed Central

    Page, Rita D; Gupta, Sumeet K; Jenkins, Thomas L; Karcioglu, Zeynel A

    2016-01-01

    Purpose The aim of this study was to identify the risk factors that are predictive of poor outcomes in penetrating globe trauma. Patients and methods This retrospective case series evaluated 103 eyes that had been surgically treated for an open-globe injury from 2007 to 2010 at the eye clinic of the University of Virginia. A total of 64 eyes with complete medical records and at least 6 months of follow-up were included in the study. Four risk factors (preoperative best-corrected visual acuity [pre-op BCVA], ocular trauma score [OTS], zone of injury [ZOI], and time lapse [TL] between injury and primary repair) and three outcomes (final BCVA, monthly rate of additional surgeries [MRAS], and enucleation) were identified for analysis. Results Pre-op BCVA was positively associated with MRAS, final BCVA, and enucleation. Calculated OTS was negatively associated with the outcome variables. No association was found between TL and ZOI with the outcome variables. Further, age and predictor variable-adjusted analyses showed pre-op BCVA to be independently positively associated with MRAS (P=0.008) and with final BCVA (P<0.001), while the calculated OTS was independently negatively associated with final BCVA (P<0.001), but not uniquely associated with MRAS (P=0.530). Conclusion Pre-op BCVA and OTS are best correlated with prognosis in open-globe injuries. However, no conventional features reliably predict the outcome of traumatized eyes. PMID:27536059

  8. Subventricular zone predicts high velocity of tumor expansion and poor clinical outcome in patients with low grade astrocytoma.

    PubMed

    Wen, Bing; Fu, Feixian; Hu, Liangbo; Cai, Qiuyi; Xie, Junshi

    2018-05-01

    The aim of this study is to clarify the association between subventricular zone (SVZ) involvement and velocity of diametric expansion(VDE) in patients with low-grade astrocytoma and also assessed the clinical outcome of those patients. A total of 168 adult patients with newly diagnosed supratentorial low-grade astrocytoma were studied retrospectively. There were 73 patients had SVZ involvement. Patients with SVZ involvement(7.16 ± 6.53 mm/y) had a higher VDE than patients without SVZ involvement(4.38 ± 5.35 mm/y). VDE was modeled as a categorical variable(<4, ≥4 and, <8, ≥8 and, <12, ≥12 mm/y). Logistic regression showed that SVZ involvement was associated with high VDE after adjusting by confounding variables. On the univariate analysis, the results showed that tumor involved with SVZ, VDE ≥ 4 mm/y, VDE ≥ 8 mm/y, and VDE ≥ 8 mm/y were significant predictors of a shorter OS, progression-free survival (PFS) and malignant progression-free survival (MFS)(all p <0.05). The categorical variables of VDE (<4 mm/y, ≥4 mm/y and, <8 mm/y, ≥8 mm/y and, <12 mm/y, ≥12 mm/y) were adjusted by confounding variables in multivariate analysis, respectively. The results indicated that VDE ≥ 8 mm/y, VDE ≥ 12 mm/y were worse prognostic factors for OS, while VDE ≥ 4 mm/y, VDE ≥ 8 mm/y and VDE ≥ 12 mm/y were related to shorter PFS and MFS. In addition, SVZ involvement was prognostic factors in predicting OS and PFS except MFS. Our results demonstrated that SVZ involvement predicted high VDE and worse clinical outcome, and high VDE was associated with poor prognosis in patients with low-grade astrocytoma. Copyright © 2018 Elsevier B.V. All rights reserved.

  9. Non-operative management of medial meniscus posterior horn root tears is associated with worsening arthritis and poor clinical outcome at 5-year follow-up.

    PubMed

    Krych, Aaron J; Reardon, Patrick J; Johnson, Nick R; Mohan, Rohith; Peter, Logan; Levy, Bruce A; Stuart, Michael J

    2017-02-01

    Medial meniscus posterior root tears (MMPRTs) are a significant source of pain and dysfunction, but little is known about the natural history and outcome and for non-operative management of these lesions. The purpose of this study was to evaluate (1) the mid-term clinical and radiographic outcomes of non-operative treatment of MMPRTs and (2) risk factors for worse outcomes. A retrospective review was performed for patients with symptomatic, unrepaired MMPRTs and a minimum 2-year follow-up for IKDC and Tegner outcome scores. Baseline and final radiographs were reviewed and graded according to Kellgren-Lawrence scores. Baseline MRIs were reviewed for the presence of meniscal extrusion, subchondral oedema, and insufficiency fractures. Failure was defined as conversion to arthroplasty or severely abnormal patient subjective IKDC score. Fifty-two patients (21M:31F) with a mean age of 58 ± 10 years were diagnosed with symptomatic MMPRTs clinically and confirmed by MRI and followed for a mean of 62 ± 30 months. Sixteen patients (31 %) underwent total knee arthroplasty at a mean of 30 ± 32 months after diagnosis with higher Kellgren-Lawrence grades associated with increased rates of arthroplasty (p = 0.01). Mean IKDC scores for the remaining patients were 61.2 ± 21 with significantly lower scores in females compared to males (75 ± 12 vs. 49 ± 20; p = 0.03). Mean Kellgren-Lawrence grades and rates of arthritis progressed over time on radiographs (1.5 ± 0.7 vs. 2.4 ± 1.0; p < 0.001 and 78 % vs. 51 %; p = 0.01). Overall, 87 % of patients failed non-operative treatment. Non-operative treatment of medial meniscus posterior horn root tears is associated with poor clinical outcome, worsening arthritis, and a relatively high rate of arthroplasty at 5-year follow-up. Female gender was associated with lower subjective scores and higher rate of arthroplasty. The current study provides a natural history benchmark for clinical outcomes that can be

  10. Prediction of Outcome From Adult Bacterial Meningitis in a High-HIV-Seroprevalence, Resource-Poor Setting Using the Malawi Adult Meningitis Score (MAMS).

    PubMed

    Wall, Emma C; Mukaka, Mavuto; Scarborough, Matthew; Ajdukiewicz, Katherine M A; Cartwright, Katharine E; Nyirenda, Mulinda; Denis, Brigitte; Allain, Theresa J; Faragher, Brian; Lalloo, David G; Heyderman, Robert S

    2017-02-15

    Acute bacterial meningitis (ABM) in adults residing in resource-poor countries is associated with mortality rates >50%. To improve outcome, interventional trials and standardized clinical algorithms are urgently required. To optimize these processes, we developed and validated an outcome prediction tool to identify ABM patients at greatest risk of death. We derived a nomogram using mortality predictors derived from a logistic regression model of a discovery database of adult Malawian patients with ABM (n = 523 [65%] cerebrospinal fluid [CSF] culture positive). We validated the nomogram internally using a bootstrap procedure and subsequently used the nomogram scores to further interpret the effects of adjunctive dexamethasone and glycerol using clinical trial data from Malawi. ABM mortality at 6-week follow-up was 54%. Five of 15 variables tested were strongly associated with poor outcome (CSF culture positivity, CSF white blood cell count, hemoglobin, Glasgow Coma Scale, and pulse rate), and were used in the derivation of the Malawi Adult Meningitis Score (MAMS) nomogram. The C-index (area under the curve) was 0.76 (95% confidence interval, .71-.80) and calibration was good (Hosmer-Lemeshow C-statistic = 5.48, df = 8, P = .705). Harmful effects of adjunctive glycerol were observed in groups with relatively low predicted risk of poor outcome (25%-50% risk): Case Fatality Rate of 21% in the placebo group and 52% in the glycerol group (P < .001). This effect was not seen with adjunctive dexamethasone. MAMS provides a novel tool for predicting prognosis and improving interpretation of ABM clinical trials by risk stratification in resource-poor settings. Whether MAMS can be applied to non-HIV-endemic countries requires further evaluation. © The Author 2016. Published by Oxford University Press for the Infectious Diseases Society of America.

  11. A review of people who did not attend an epilepsy clinic and their clinical outcomes.

    PubMed

    Minshall, I; Neligan, A

    2017-08-01

    To review the clinical outcomes of people who failed to attend or failed subsequent follow up in a Primary Care based specialist epilepsy service. The case notes of 200 people who had failed to initially attend the service or subsequent follow up from 2005 to 2013 were reviewed. Clinical outcomes were determined for 152 people, with the remaining 48 having left the area. For those not attending at all, 64% had no further recorded events, a further 22% came under alternative specialist care and were managed appropriately, 6% were already in remission at the time of referral or at follow up and stayed seizure free. For people attending, but were subsequently lost to follow up, 78% were in remission, had improved seizure frequency, and normal pregnancies. In total 6% of those with poor control came under subsequent Neurological care. This study suggests that for the majority of people who fail to attend or are lost to follow up in a primary care specialist epilepsy clinic, the primary reasons appear to be that they had no further events, improved seizure control or that seizure remission has been achieved. The majority with persistent poor control came under Neurological care. Copyright © 2017 British Epilepsy Association. Published by Elsevier Ltd. All rights reserved.

  12. Breast Tumors with Elevated Expression of 1q Candidate Genes Confer Poor Clinical Outcome and Sensitivity to Ras/PI3K Inhibition

    PubMed Central

    Viveka Thangaraj, Soundara; Periasamy, Jayaprakash; Bhaskar Rao, Divya; Barnabas, Georgina D.; Raghavan, Swetha; Ganesan, Kumaresan

    2013-01-01

    Genomic aberrations are common in cancers and the long arm of chromosome 1 is known for its frequent amplifications in breast cancer. However, the key candidate genes of 1q, and their contribution in breast cancer pathogenesis remain unexplored. We have analyzed the gene expression profiles of 1635 breast tumor samples using meta-analysis based approach and identified clinically significant candidates from chromosome 1q. Seven candidate genes including exonuclease 1 (EXO1) are consistently over expressed in breast tumors, specifically in high grade and aggressive breast tumors with poor clinical outcome. We derived a EXO1 co-expression module from the mRNA profiles of breast tumors which comprises 1q candidate genes and their co-expressed genes. By integrative functional genomics investigation, we identified the involvement of EGFR, RAS, PI3K / AKT, MYC, E2F signaling in the regulation of these selected 1q genes in breast tumors and breast cancer cell lines. Expression of EXO1 module was found as indicative of elevated cell proliferation, genomic instability, activated RAS/AKT/MYC/E2F1 signaling pathways and loss of p53 activity in breast tumors. mRNA–drug connectivity analysis indicates inhibition of RAS/PI3K as a possible targeted therapeutic approach for the patients with activated EXO1 module in breast tumors. Thus, we identified seven 1q candidate genes strongly associated with the poor survival of breast cancer patients and identified the possibility of targeting them with EGFR/RAS/PI3K inhibitors. PMID:24147022

  13. Cytoplasmic localization of alteration/deficiency in activation 3 (ADA3) predicts poor clinical outcome in breast cancer patients.

    PubMed

    Mirza, Sameer; Rakha, Emad A; Alshareeda, Alaa; Mohibi, Shakur; Zhao, Xiangshan; Katafiasz, Bryan J; Wang, Jun; Gurumurthy, Channabasavaiah Basavaraju; Bele, Aditya; Ellis, Ian O; Green, Andrew R; Band, Hamid; Band, Vimla

    2013-02-01

    Transcriptional activation by estrogen receptor (ER) is a key step to breast oncogenesis. Given previous findings that ADA3 is a critical component of HAT complexes that regulate ER function and evidence that overexpression of other ER coactivators such as SRC-3 is associated with clinical outcomes in breast cancer, the current study was designed to assess the potential significance of ADA3 expression/localization in human breast cancer patients. In this study, we analyzed ADA3 expression in breast cancer tissue specimens and assessed the correlation of ADA3 staining with cancer progression and patient outcome. Tissue microarrays prepared from large series of breast cancer patients with long-term follow-ups were stained with anti-ADA3 monoclonal antibody using immunohistochemistry. Samples were analyzed for ADA3 expression followed by correlation with various clinicopathological parameters and patients' outcomes. We report that breast cancer specimens show predominant nuclear, cytoplasmic, or mixed nuclear + cytoplasmic ADA3 staining patterns. Predominant nuclear ADA3 staining correlated with ER+ status. While predominant cytoplasmic ADA3 staining negatively correlated with ER+ status, but positively correlated with ErbB2, EGFR, and Ki67. Furthermore, a positive correlation of cytoplasmic ADA3 was observed with higher histological grade, mitotic counts, Nottingham Prognostic Index, and positive vascular invasion. Patients with nuclear ADA3 and ER positivity have better breast cancer specific survival and distant metastasis free survival. Significantly, cytoplasmic expression of ADA3 showed a strong positive association with reduced BCSS and DMFS in ErbB2+/EGFR+ patients. Although in multivariate analyses ADA3 expression was not an independent marker of survival, predominant nuclear ADA3 staining in breast cancer tissues correlates with ER+ expression and together serves as a marker of good prognosis, whereas predominant cytoplasmic ADA3 expression correlates with

  14. The Association Between Spontaneous Hyperventilation, Delayed Cerebral Ischemia, and Poor Neurological Outcome in Patients with Subarachnoid Hemorrhage.

    PubMed

    Williamson, Craig A; Sheehan, Kyle M; Tipirneni, Renuka; Roark, Christopher D; Pandey, Aditya S; Thompson, B Gregory; Rajajee, Venkatakrishna

    2015-12-01

    The frequency and associations of spontaneous hyperventilation in subarachnoid hemorrhage (SAH) are unknown. Because hyperventilation decreases cerebral blood flow, it may exacerbate delayed cerebral ischemia (DCI) and worsen neurological outcome. This is a retrospective analysis of data from a prospectively collected cohort of SAH patients at an academic medical center. Spontaneous hyperventilation was defined by PaCO2 <35 mmHg and pH >7.45 and subdivided into moderate and severe groups. Clinical and demographic characteristics of patients with and without spontaneous hyperventilation were compared using χ (2) or t tests. Bivariate and multivariable logistic regression analyses were conducted to examine the association of moderate and severe hyperventilation with DCI and discharge neurological outcome. Of 207 patients, 113 (55 %) had spontaneous hyperventilation. Spontaneously hyperventilating patients had greater illness severity as measured by the Hunt-Hess, World Federation of Neurosurgical Societies (WFNS), and SAH sum scores. They were also more likely to develop the following complications: pneumonia, neurogenic myocardial injury, systemic inflammatory response syndrome (SIRS), radiographic vasospasm, DCI, and poor neurological outcome. In a multivariable logistic regression model including age, gender, WFNS, SAH sum score, pneumonia, neurogenic myocardial injury, etiology, and SIRS, only moderate [odds ratio (OR) 2.49, 95 % confidence interval (CI) 1.10-5.62] and severe (OR 3.12, 95 % CI 1.30-7.49) spontaneous hyperventilation were associated with DCI. Severe spontaneous hyperventilation (OR 4.52, 95 % CI 1.37-14.89) was also significantly associated with poor discharge outcome in multivariable logistic regression analysis. Spontaneous hyperventilation is common in SAH and is associated with DCI and poor neurological outcome.

  15. Poor Employment Conditions Adversely Affect Mental Health Outcomes Among Surgical Trainees.

    PubMed

    Kevric, Jasmina; Papa, Nathan; Perera, Marlon; Rashid, Prem; Toshniwal, Sumeet

    Poor mental health in junior clinicians is prevalent and may lead to poor productivity and significant medical errors. We aimed to provide contemporary data on the mental health of surgical trainees and identify risk factors relating to poorer mental health outcomes. A detailed questionnaire was developed comprising questions based on the 36-item short-form health survey (SF-36) and Physical Activity Questionnaire. Each of the questionnaires has proven validity and reliability in the clinical context. Ethics approval was obtained from the Royal Australasian College of Surgeons. The questionnaire was aimed at surgical registrars. We used Physical Activity Questionnaire, SF-36 scores and linear regression to evaluate the effect of putative predictors on mental health. A total of 83 responses were collected during the study period, of which 49 (59%) were from men and 34 (41%) were from women. The mean Mental Component Summary (MCS) score for both sexes was significantly lower than the population mean at ages 25-34 (p < 0.001). Poor satisfaction with one's work culture and a feeling of a lack of support at work were extremely strong predictors of a lower MCS score (p < 0.001). Hours of overtime worked, particularly unpaid overtime, were also strong predictors of a poorer score. Australian surgical trainees reported lower MCS scores from the SF-36 questionnaire compared to the general population. Increasing working hours, unpaid overtime, poor job security, and job satisfaction were associated with poorer scores among trainees. Interventions providing improved working conditions need to be considered by professional training bodies and employers. Copyright © 2018 Association of Program Directors in Surgery. All rights reserved.

  16. Mastl overexpression is associated with epithelial to mesenchymal transition and predicts a poor clinical outcome in gastric cancer.

    PubMed

    Sun, Xian-Jun; Li, Yan-Liang; Wang, Long-Gang; Liu, Li-Qing; Ma, Heng; Hou, Wen-Hong; Yu, Jin-Ming

    2017-12-01

    Microtubule-associated serine/threonine kinase like (Mastl) is deregulated in a number of types of human malignancy and may be a kinase target for cancer treatment. The aim of the present study was to determine the Mastl expression in gastric cancer and to clarify its clinical and prognostic significance. Immunohistochemistry was performed on a cohort of 126 postoperative gastric cancer samples to detect the expression of Mastl and two epithelial to mesenchymal transition (EMT) markers, epithelial-cadherin and Vimentin. The χ 2 test, Kaplan-Meier estimator analysis and Cox's regression model were used to analyze the data. Upregulated Mastl protein expression was observed in the gastric cancer tissues compared with that in the adjacent non-cancerous gastric tissues. Increased Mastl expression was identified in 54/126 (42.9%) gastric cancer samples, and was significantly associated with lymph node metastasis, tumor relapse, EMT status and poor overall survival. Additional analysis demonstrated that the Mastl expression level stratified the patient outcome in stage III, but not stage II tumor subgroups. Cox's regression analysis revealed that increased Mastl expression was an independent prognostic factor for patients with gastric cancer. Mastl expression may be a valuable prognostic marker and a potential target for patients with gastric cancer.

  17. Medial medullary infarction: clinical, imaging, and outcome study in 86 consecutive patients.

    PubMed

    Kim, Jong S; Han, Young S

    2009-10-01

    Clinical-imaging correlation and long-term clinical outcomes remain to be investigated in medial medullary infarction (MMI). We studied clinical, MRI, and angiographic data of 86 consecutive MMI patients. The lesions were correlated with clinical findings, and long-term outcomes, divided into mild and severe (modified Rankin scale >3), were assessed by telephone interview. Central poststroke pain (CPSP) was defined as persistent pain with visual numeric scale > or = 4. The lesions were located mostly in the rostral medulla (rostral 76%, rostral+middle 16%), while ventro-dorsal lesion patterns include ventral (V, 20%), ventral+middle (VM, 33%), and ventral+middle+dorsal (VMD, 41%). Clinical manifestations included motor dysfunction in 78 patients (91%), sensory dysfunction in 59 (73%), and vertigo/dizziness in 51 (59%), each closely related to involvement of ventral, middle, and dorsal portions, respectively (P<0.001, each). Vertebral artery (VA) atherosclerotic disease relevant to the infarction occurred in 53 (62%) patients, mostly producing atheromatous branch occlusion (ABO). Small vessel disease (SVD) occurred in 24 (28%) patients. ABO was more closely related to VMD (versus V+VM) than was SVD (P=0.035). During follow-up (mean 71 months), 11 patients died, and recurrent strokes occurred in 11. Old age (P=0.001) and severe motor dysfunction at admission (P=0.001) were factors predicting poor prognosis. CPSP, occurring in 21 patients, was closely (P=0.013) related to poor clinical outcome. MMI usually presents with a rostral medullary lesion, with a good clinical ventro-dorsal imaging correlation, caused most frequently by ABO followed by SVD. A significant proportion of patients remain dependent or have CPSP.

  18. Increased Arterial Stiffness after Coronary Artery Revascularization Correlates with Serious Coronary Artery Lesions and Poor Clinical Outcomes in Patients with Chronic Kidney Disease

    PubMed Central

    Zhu, Zhengbin; Yan, Zijun; Zhang, Lin; Du, Run; Zhu, Jinzhou; Zuo, Junli; Chu, Shaoli; Shen, Weifeng; Zhang, Ruiyan

    2014-01-01

    Objectives This study aimed to clarify the relationship between arterial stiffness and coronary artery lesions as well as their influence on long-term outcomes after coronary artery revascularization in patients with chronic kidney disease (CKD). Methods A total of 205 patients who had a coronary angiography and received coronary artery revascularization on demand were enrolled and followed up for 5 years. Demographic and clinical indicators, arterial stiffness indexes, angiographic characteristics and the Gensini score (GS) were recorded at baseline. Major adverse cardiac events (MACE), including cardiac death and repeat coronary artery revascularization, that occurred during the 5 years of follow-up were also recorded. Results All indexes reflecting the degree of arterial stiffness, including PWV, C1, C2, CSBP, CDBP, AP and Aix, were significantly higher in CKD than in non-CKD patients (all p < 0.05). Patients with CKD also had a higher rate of coronary artery disease and a higher GS (p < 0.05 and p < 0.01, respectively). Logistic regression analysis revealed CKD to be an independent risk factor for increased arterial stiffness (OR = 2.508, 95% CI 1.308-4.808, p = 0.006). During follow-up, CKD patients with PWV >13 m/s or Aix@75 >30 had a significantly higher MACE occurrence rate after coronary artery revascularization (both p < 0.05). Conclusion These results highlight that CKD and arterial stiffness correlate with the severity of coronary artery lesions. CKD patients with impaired arterial stiffness have poor clinical outcomes, suggesting a further clinical use of the arterial stiffness index as a surrogate of worse cardiovascular prognosis in CKD than in non-CKD patients. PMID:25737692

  19. [Developmental dysplasia of the hip in children with a psychomotor disorder. A risk factor for a poor outcome?].

    PubMed

    Pipa-Muñiz, Iván; de Los Llanos Rodríguez-Rodríguez, María; Felgueroso-Juliana, M Blanca; Riera-Campillo, Manuela; González-Herranz, Pedro

    2016-09-01

    Orthopaedic treatment of developmental dysplasia of the hip (DDH) has a high success rate in cases that are diagnosed early. However, the outcomes of these patients are not really known when they are subsequently diagnosed with some type of cerebral impairment. A retrospective observational study was conducted on cases of DDH with a poor outcome after orthopaedic treatment, being unknown if they had any type of psychomotor disorder. The patients were clinically and radiologically assessed, and afterwards received neurological valuation by the Child Neurology Unit. Of the 325 cases of DDH diagnosed in 293 patients, 10 patients (3%) with 16 hips with DDH were diagnosed of any cerebral impairment. All them were initially treated orthopedically. Clinical and radiologically evolution was succesful only in 4 cases (25%) being necessary any surgical procedure in the remaining 12 cases. After surgical treatment we got an improvement in the Acetabular Index (p=0.005) and Reimers Extrusion Index (p=0.042). Neck-shaft angle and Wiberg CE angle also improved but this difference was not statically significant. Cerebral impairment was diagnosed at 2,5 years of age and the begining of walking was delayed at 2.4 years of age. Cerebral impairment can lead to an unfavourable outcome in the treatment of DDH, with the relative risk of a poor outcome being 7.2 times higher in these patients. An unfavourable outcome with conventional treatment of DDH must make us suspect the presence of some type of neurological disorder, particularly if there is a delay in walking. Copyright © 2015 Asociación Española de Pediatría. Publicado por Elsevier España, S.L.U. All rights reserved.

  20. The impact of depression and antidepressant usage on primary biliary cholangitis clinical outcomes

    PubMed Central

    Kaplan, Gilaad G.; Almishri, Wagdi; Vallerand, Isabelle; Frolkis, Alexandra D.; Patten, Scott; Swain, Mark G.

    2018-01-01

    Background Depression is prevalent in primary biliary cholangitis (PBC) patients. Our aims were to examine the effects of depression and antidepressants on hepatic outcomes of PBC patients. Methods We used the UK Health Improvement Network database to identify PBC patients between 1974 and 2007. Our primary outcome was one of three clinical events: decompensated cirrhosis, liver transplantation and death. We assessed depression and each class of antidepressant medication in adjusted multivariate Cox proportional hazards models to identify independent predictors of outcomes. In a sensitivity analysis, the study population was restricted to PBC patients using ursodeoxycholic acid (UDCA). Results We identified 1,177 PBC patients during our study period. In our cohort, 86 patients (7.3%) had a depression diagnosis prior to PBC diagnosis, while 79 patients (6.7%) had a depression diagnosis after PBC diagnosis. Ten-year incidence of mortality, decompensated cirrhosis, and liver transplantation were 13.4%, 6.6%, and 2.0%, respectively. In our adjusted models, depression status was not a predictor of poor outcomes. After studying all classes of antidepressants, using the atypical antidepressant mirtazapine after PBC diagnosis was significantly protective (Adjusted HR 0.23: 95% CI 0.07–0.72) against poor liver outcomes (decompensation, liver transplant, mortality), which remained statistically significant in patients using UCDA (HR 0.21: 95% CI 0.05–0.83). Conclusions In our study, depression was not associated with poor clinical outcomes. However, using the antidepressant mirtazapine was associated with decreased mortality, decompensated cirrhosis and liver transplantation in PBC patients. These findings support further assessment of mirtazapine as a potential treatment for PBC patients. PMID:29617396

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

    PubMed Central

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

    2015-01-01

    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

  2. How food insecurity contributes to poor HIV health outcomes: Qualitative evidence from the San Francisco Bay Area.

    PubMed

    Whittle, Henry J; Palar, Kartika; Seligman, Hilary K; Napoles, Tessa; Frongillo, Edward A; Weiser, Sheri D

    2016-12-01

    Food-insecure people living with HIV/AIDS (PLHIV) consistently exhibit worse clinical outcomes than their food-secure counterparts. This relationship is mediated in part through non-adherence to antiretroviral therapy (ART), sub-optimal engagement in HIV care, and poor mental health. An in-depth understanding of how these pathways operate in resource-rich settings, however, remains elusive. We aimed to understand the relationship between food insecurity and HIV health among low-income individuals in the San Francisco Bay Area using qualitative methods. Semi-structured in-depth interviews were conducted with 34 low-income PLHIV receiving food assistance from a non-profit organization. Interviews explored experiences with food insecurity and its perceived effects on HIV-related health, mental health, and health behaviors including taking ART and attending clinics. Thematic content analysis of transcripts followed an integrative inductive-deductive approach. Food insecurity was reported to contribute to poor ART adherence and missing scheduled clinic visits through various mechanisms, including exacerbated ART side effects in the absence of food, physical feelings of hunger and fatigue, and HIV stigma at public free-meal sites. Food insecurity led to depressive symptoms among participants by producing physical feelings of hunger, aggravating pre-existing struggles with depression, and nurturing a chronic self-perception of social failure. Participants further explained how food insecurity, depression, and ART non-adherence could reinforce each other in complex interactions. Our study demonstrates how food insecurity detrimentally shapes HIV health behavior and outcomes through complex and interacting mechanisms, acting via multiple socio-ecological levels of influence in this setting. The findings emphasize the need for broad, multisectoral approaches to tackling food insecurity among urban poor PLHIV in the United States. Copyright © 2016 Elsevier Ltd. All rights

  3. Urban trees and the risk of poor birth outcomes

    Treesearch

    Geoffrey H. Donovan; Yvonne L. Michael; David T. Butry; Amy D. Sullivan; John M. Chase

    2011-01-01

    This paper investigated whether greater tree-canopy cover is associated with reduced risk of poor birth outcomes in Portland, Oregon. Residential addresses were geocoded and linked to classified-aerial imagery to calculate tree-canopy cover in 50, 100, and 200 m buffers around each home in our sample (n=5696). Detailed data on maternal characteristics and additional...

  4. Anti-NMDA receptor encephalitis: clinical characteristics, predictors of outcome and the knowledge gap in southwest China.

    PubMed

    Wang, W; Li, J-M; Hu, F-Y; Wang, R; Hong, Z; He, L; Zhou, D

    2016-03-01

    The aim was to analyse the clinical profiles and outcomes of patients with anti- N-methyl-d-aspartate receptor (anti-NMDAR) encephalitis in China. A retrospective study of anti-NMDAR encephalitis in China was performed between June 2011 and June 2014. The clinical characteristics and predictors of poor outcome were determined. A total of 51 patients with a definitive diagnosis of anti-NMDAR encephalitis were included in this study. Four of them were surgically confirmed to have a neoplasm. Thirty-two patients, amongst whom 24 were female, presented with psychiatric disorder as the initial symptom, whereas 14 patients, of whom nine were male, presented with seizure as the initial symptom (P = 0.011). Twenty-nine patients (56.86%) were initially misdiagnosed with psychosis, viral encephalitis or other diseases, and 58.8% of the patients experienced at least one type of complication. It typically took 3 weeks before these patients were admitted to our hospital and another 2 weeks before the correct diagnosis was made. Forty-one patients (80%) reached a good outcome; 10 patients (20%) had a poor outcome. Older age, extended hospital stay, memory deficits, decreased consciousness, central hypoventilation, complications and abnormal cerebrospinal fluid results were associated with poor outcome (P < 0.05). Female patients more frequently initially present with psychiatric disorder but male patients more frequently initially present with seizure. Patients with anti-NMDAR encephalitis in China have a lower incidence of neoplasm. Nevertheless, this study reveals several challenges in treating anti-NMDAR encephalitis in China that may contribute to poor outcome. © 2015 EAN.

  5. Predictors of poor outcome despite recanalization: a multiple regression analysis of the NASA registry.

    PubMed

    Linfante, Italo; Starosciak, Amy K; Walker, Gail R; Dabus, Guilherme; Castonguay, Alicia C; Gupta, Rishi; Sun, Chung-Huan J; Martin, Coleman; Holloway, William E; Mueller-Kronast, Nils; English, Joey D; Malisch, Tim W; Marden, Franklin A; Bozorgchami, Hormozd; Xavier, Andrew; Rai, Ansaar T; Froehler, Michael T; Badruddin, Aamir; Nguyen, Thanh N; Taqi, M Asif; Abraham, Michael G; Janardhan, Vallabh; Shaltoni, Hashem; Novakovic, Roberta; Yoo, Albert J; Abou-Chebl, Alex; Chen, Peng R; Britz, Gavin W; Kaushal, Ritesh; Nanda, Ashish; Issa, Mohammad A; Nogueira, Raul G; Zaidat, Osama O

    2016-03-01

    Mechanical thrombectomy with stent-retrievers results in higher recanalization rates compared with previous devices. Despite successful recanalization rates (Thrombolysis in Cerebral Infarction (TICI) score ≥2b) of 70-83%, good outcomes by 90-day modified Rankin Scale (mRS) score ≤2 are achieved in only 40-55% of patients. We evaluated predictors of poor outcomes (mRS >2) despite successful recanalization (TICI ≥2b) in the North American Solitaire Stent Retriever Acute Stroke (NASA) registry. Logistic regression was used to evaluate baseline characteristics and recanalization outcomes for association with 90-day mRS score of 0-2 (good outcome) vs 3-6 (poor outcome). Univariate tests were carried out for all factors. A multivariable model was developed based on backwards selection from the factors with at least marginal significance (p≤0.10) on univariate analysis with the retention criterion set at p≤0.05. The model was refit to minimize the number of cases excluded because of missing covariate values; the c-statistic was a measure of predictive power. Of 354 patients, 256 (72.3%) were recanalized successfully. Based on 234 recanalized patients evaluated for 90-day mRS score, 116 (49.6%) had poor outcomes. Univariate analysis identified an increased risk of poor outcome for age ≥80 years, occlusion site of internal carotid artery (ICA)/basilar artery, National Institute of Health Stroke Scale (NIHSS) score ≥18, history of diabetes mellitus, TICI 2b, use of rescue therapy, not using a balloon-guided catheter or intravenous tissue plasminogen activator (IV t-PA), and >30 min to recanalization (p≤0.05). In multivariable analysis, age ≥80 years, occlusion site ICA/basilar, initial NIHSS score ≥18, diabetes, absence of IV t-PA, ≥3 passes, and use of rescue therapy were significant independent predictors of poor 90-day outcome in a model with good predictive power (c-index=0.80). Age, occlusion site, high NIHSS, diabetes, no IV t-PA, ≥3

  6. Medial Unicondylar Knee Arthroplasty Improves Patellofemoral Congruence: a Possible Mechanistic Explanation for Poor Association Between Patellofemoral Degeneration and Clinical Outcome.

    PubMed

    Thein, Ran; Zuiderbaan, Hendrik A; Khamaisy, Saker; Nawabi, Danyal H; Poultsides, Lazaros A; Pearle, Andrew D

    2015-11-01

    The purpose was to determine the effect of medial fixed bearing unicondylar knee arthroplasty (UKA) on postoperative patellofemoral joint (PFJ) congruence and analyze the relationship of preoperative PFJ degeneration on clinical outcome. We retrospectively reviewed 110 patients (113 knees) who underwent medial UKA. Radiographs were evaluated to ascertain PFJ degenerative changes and congruence. Clinical outcomes were assessed preoperatively and postoperatively. The postoperative absolute patellar congruence angle (10.05 ± 10.28) was significantly improved compared with the preoperative value (14.23 ± 11.22) (P = 0.0038). No correlation was found between preoperative PFJ congruence or degeneration severity, and WOMAC scores at two-year follow up. Pre-operative PFJ congruence and degenerative changes do not affect UKA clinical outcomes. This finding may be explained by the post-op PFJ congruence improvement. Copyright © 2015 Elsevier Inc. All rights reserved.

  7. Postoperative Biomarkers Predict Acute Kidney Injury and Poor Outcomes after Pediatric Cardiac Surgery

    PubMed Central

    Devarajan, Prasad; Zappitelli, Michael; Sint, Kyaw; Thiessen-Philbrook, Heather; Li, Simon; Kim, Richard W.; Koyner, Jay L.; Coca, Steven G.; Edelstein, Charles L.; Shlipak, Michael G.; Garg, Amit X.; Krawczeski, Catherine D.

    2011-01-01

    Acute kidney injury (AKI) occurs commonly after pediatric cardiac surgery and associates with poor outcomes. Biomarkers may help the prediction or early identification of AKI, potentially increasing opportunities for therapeutic interventions. Here, we conducted a prospective, multicenter cohort study involving 311 children undergoing surgery for congenital cardiac lesions to evaluate whether early postoperative measures of urine IL-18, urine neutrophil gelatinase-associated lipocalin (NGAL), or plasma NGAL could identify which patients would develop AKI and other adverse outcomes. Urine IL-18 and urine and plasma NGAL levels peaked within 6 hours after surgery. Severe AKI, defined by dialysis or doubling in serum creatinine during hospital stay, occurred in 53 participants at a median of 2 days after surgery. The first postoperative urine IL-18 and urine NGAL levels strongly associated with severe AKI. After multivariable adjustment, the highest quintiles of urine IL-18 and urine NGAL associated with 6.9- and 4.1-fold higher odds of AKI, respectively, compared with the lowest quintiles. Elevated urine IL-18 and urine NGAL levels associated with longer hospital stay, longer intensive care unit stay, and duration of mechanical ventilation. The accuracy of urine IL-18 and urine NGAL for diagnosis of severe AKI was moderate, with areas under the curve of 0.72 and 0.71, respectively. The addition of these urine biomarkers improved risk prediction over clinical models alone as measured by net reclassification improvement and integrated discrimination improvement. In conclusion, urine IL-18 and urine NGAL, but not plasma NGAL, associate with subsequent AKI and poor outcomes among children undergoing cardiac surgery. PMID:21836147

  8. Soluble intercellular adhesion molecule-1 and clinical outcomes in patients with acute lung injury

    PubMed Central

    Eisner, Mark D.; Parsons, Polly E.; Thompson, B. Taylor; Conner, Edward R.; Matthay, Michael A.; Ware, Lorraine B.

    2009-01-01

    Objective To determine if levels of soluble intercellular adhesion molecule-1 (sICAM-1), a marker of alveolar epithelial and endothelial injury, differ in patients with hydrostatic pulmonary edema and acute lung injury (ALI) and are associated with clinical outcomes in patients with ALI. Design, setting, and participants Measurement of sICAM-1 levels in (1) plasma and edema fluid from 67 patients with either hydrostatic pulmonary edema or ALI enrolled in an observational, prospective single center study, and (2) in plasma from 778 patients with ALI enrolled in a large multi-center randomized controlled trial of ventilator strategy. Results In the single-center study, levels of sICAM-1 were significantly higher in both edema fluid and plasma (median 938 and 545 ng/ml, respectively) from ALI patients compared to hydrostatic edema patients (median 384 and 177 ng/ml, P < 0.03 for both comparisons). In the multi-center study, higher plasma sICAM-1 levels were associated with poor clinical outcomes in both unadjusted and multivariable models. Subjects with ALI whose plasma sICAM-1 levels increased over the first 3 days of the study had a higher risk of death, after adjusting for other important predictors of outcome (odds ratio 1.48; 95% CI 1.03–2.12, P = 0.03). Conclusions Both plasma and edema fluid levels of sICAM-1 are higher in patients with ALI than in patients with hydrostatic pulmonary edema. Higher plasma sICAM-1 levels and increasing sICAM-1 levels over time are associated with poor clinical outcomes in ALI. Measurement of sICAM-1 levels may be useful for identifying patients at highest risk of poor outcomes from ALI. PMID:18670758

  9. Elevated Fasting Blood Glucose Is Predictive of Poor Outcome in Non-Diabetic Stroke Patients: A Sub-Group Analysis of SMART.

    PubMed

    Yao, Ming; Ni, Jun; Zhou, Lixin; Peng, Bin; Zhu, Yicheng; Cui, Liying

    2016-01-01

    Although increasing evidence suggests that hyperglycemia following acute stroke adversely affects clinical outcome, whether the association between glycaemia and functional outcome varies between stroke patients with\\without pre-diagnosed diabetes remains controversial. We aimed to investigate the relationship between the fasting blood glucose (FBG) and the 6-month functional outcome in a subgroup of SMART cohort and further to assess whether this association varied based on the status of pre-diagnosed diabetes. Data of 2862 patients with acute ischemic stroke (629 with pre-diagnosed diabetics) enrolled from SMART cohort were analyzed. Functional outcome at 6-month post-stroke was measured by modified Rankin Scale (mRS) and categorized as favorable (mRS:0-2) or poor (mRS:3-5). Binary logistic regression model, adjusting for age, gender, educational level, history of hypertension and stroke, baseline NIHSS and treatment group, was used in the whole cohort to evaluate the association between admission FBG and functional outcome. Stratified logistic regression analyses were further performed based on the presence/absence of pre-diabetes history. In the whole cohort, multivariable logistical regression showed that poor functional outcome was associated with elevated FBG (OR1.21 (95%CI 1.07-1.37), p = 0.002), older age (OR1.64 (95% CI1.38-1.94), p<0.001), higher NIHSS (OR2.90 (95%CI 2.52-3.33), p<0.001) and hypertension (OR1.42 (95%CI 1.13-1.98), p = 0.04). Stratified logistical regression analysis showed that the association between FBG and functional outcome remained significant only in patients without pre-diagnosed diabetes (OR1.26 (95%CI 1.03-1.55), p = 0.023), but not in those with premorbid diagnosis of diabetes (p = 0.885). The present results demonstrate a significant association between elevated FBG after stroke and poor functional outcome in patients without pre-diagnosed diabetes, but not in diabetics. This finding confirms the importance of glycemic

  10. Neonatal Pulmonary MRI of Bronchopulmonary Dysplasia Predicts Short-term Clinical Outcomes.

    PubMed

    Higano, Nara S; Spielberg, David R; Fleck, Robert J; Schapiro, Andrew H; Walkup, Laura L; Hahn, Andrew D; Tkach, Jean A; Kingma, Paul S; Merhar, Stephanie L; Fain, Sean B; Woods, Jason C

    2018-05-23

    Bronchopulmonary dysplasia (BPD) is a serious neonatal pulmonary condition associated with premature birth, but the underlying parenchymal disease and trajectory are poorly characterized. The current NICHD/NHLBI definition of BPD severity is based on degree of prematurity and extent of oxygen requirement. However, no clear link exists between initial diagnosis and clinical outcomes. We hypothesized that magnetic resonance imaging (MRI) of structural parenchymal abnormalities will correlate with NICHD-defined BPD disease severity and predict short-term respiratory outcomes. Forty-two neonates (20 severe BPD, 6 moderate, 7 mild, 9 non-BPD controls; 40±3 weeks post-menstrual age) underwent quiet-breathing structural pulmonary MRI (ultrashort echo-time and gradient echo) in a NICU-sited, neonatal-sized 1.5T scanner, without sedation or respiratory support unless already clinically prescribed. Disease severity was scored independently by two radiologists. Mean scores were compared to clinical severity and short-term respiratory outcomes. Outcomes were predicted using univariate and multivariable models including clinical data and scores. MRI scores significantly correlated with severities and predicted respiratory support at NICU discharge (P<0.0001). In multivariable models, MRI scores were by far the strongest predictor of respiratory support duration over clinical data, including birth weight and gestational age. Notably, NICHD severity level was not predictive of discharge support. Quiet-breathing neonatal pulmonary MRI can independently assess structural abnormalities of BPD, describe disease severity, and predict short-term outcomes more accurately than any individual standard clinical measure. Importantly, this non-ionizing technique can be implemented to phenotype disease and has potential to serially assess efficacy of individualized therapies.

  11. Perceived Appetite and Clinical Outcomes in Children with Chronic Kidney Disease

    PubMed Central

    Ayestaran, Frank W.; Schneider, Michael F.; Kaskel, Frederick J.; Srivaths, Poyyapakkam R.; Seo-Mayer, Patricia W.; Moxey-Mims, Marva; Furth, Susan L.; Warady, Bradley A.; Greenbaum, Larry A.

    2017-01-01

    Background Children with chronic kidney disease (CKD) may have impaired caloric intake through a variety of mechanisms, with decreased appetite as a putative contributor. In adult CKD, decreased appetite has been associated with poor clinical outcomes. There is limited information about this relationship in pediatric CKD. Methods 879 participants of the Chronic Kidney Disease in Children (CKiD) study were studied. Self-reported appetite was assessed annually and categorized as very good, good, fair, or poor/very poor. The relationship between appetite and iohexol or estimated glomerular filtration rate (ieGFR), annual changes in anthropometrics z-scores, hospitalizations, emergency room visits, and quality of life were assessed. Results An ieGFR< 30 ml/min per 1.73m2 was associated with a 4.46 greater odds (95% confidence interval: 2.80, 7.09) of having a worse appetite than those with ieGFR >90. Appetite did not predict changes in height, weight, or BMI z-scores. Patients not reporting a very good appetite had more hospitalizations over the next year than those with a very good appetite. Worse appetite was significantly associated with lower parental and patient reported quality of life. Conclusions Self-reported appetite in children with CKD worsens with lower ieGFR and is correlated with clinical outcomes, including hospitalizations and quality of life. PMID:26857711

  12. Perceived appetite and clinical outcomes in children with chronic kidney disease.

    PubMed

    Ayestaran, Frank W; Schneider, Michael F; Kaskel, Frederick J; Srivaths, Poyyapakkam R; Seo-Mayer, Patricia W; Moxey-Mims, Marva; Furth, Susan L; Warady, Bradley A; Greenbaum, Larry A

    2016-07-01

    Children with chronic kidney disease (CKD) may have impaired caloric intake through a variety of mechanisms, with decreased appetite as a putative contributor. In adult CKD, decreased appetite has been associated with poor clinical outcomes. There is limited information about this relationship in pediatric CKD. A total of 879 participants of the Chronic Kidney Disease in Children (CKiD) study were studied. Self-reported appetite was assessed annually and categorized as very good, good, fair, or poor/very poor. The relationship between appetite and iohexol or estimated glomerular filtration rate (ieGFR), annual changes in anthropometrics z-scores, hospitalizations, emergency room visits, and quality of life were assessed. An ieGFR < 30 ml/min per 1.73 m(2) was associated with a 4.46 greater odds (95 % confidence interval: 2.80, 7.09) of having a worse appetite than those with ieGFR >90. Appetite did not predict changes in height, weight, or BMI z-scores. Patients not reporting a very good appetite had more hospitalizations over the next year than those with a very good appetite. Worse appetite was significantly associated with lower parental and patient reported quality of life. Self-reported appetite in children with CKD worsens with lower ieGFR and is correlated with clinical outcomes, including hospitalizations and quality of life.

  13. Risk factors for decreased range of motion and poor outcomes in open periarticular elbow fractures.

    PubMed

    Dickens, Jonathan F; Wilson, Kevin W; Tintle, Scott M; Heckert, Reed; Gordon, Wade T; D'Alleyrand, Jean-Claude G; Potter, Benjamin K

    2015-04-01

    The purpose of this study was to identify risk factors present at the time of injury that predict poor functional outcomes and heterotopic ossification (HO) in open periarticular elbow fractures. We performed a retrospective review of 136 combat-related open elbow fractures from 2003 to 2010. Patient demographics, injury characteristics, treatment variables, and complications were recorded. Functional outcomes were analyzed to determine range of motion (ROM) and Mayo Elbow Performance Score (MEPS). Secondary outcome measures included the development of HO, return to duty, and revision operation. At a median 2.7 years from injury the median MEPS was 67.8 (range 30-100) with an average ulnohumeral arc motion of 89°. Bipolar fractures, with periarticular fractures on both sides of the elbow and at least one side containing intra-articular extension, were independently associated with decreased ulnohumeral motion (p=0.02) and decreased MEPS (p<0.004). Additional independent risk factors for decreased ROM included more severe osseous comminution (p=0.001), and increased time to definitive fixation (p=0.03) and HO (p=0.02). More severe soft tissue injury (Gustilo and Anderson fracture type, p=0.02), peripheral nerve injury (p=0.04), and HO (p=0.03) were independently associated with decreased MEPS. HO developed in 65% (89/136) of extremities and was associated with more severe Orthopaedic Trauma Association (OTA) fracture type (p=0.01) and escalating Gustilo and Anderson fracture classification (p=0.049). In the largest series of open elbow fractures, we identified risk factors that portend a poor clinical outcome and decreased ROM. Bipolar elbow fractures, which have not previously been associated with worse results, are particularly prone to decreased ROM and worse outcomes. Prognostic level IV. Published by Elsevier Ltd.

  14. Risk of Adverse Pregnancy Outcomes among Women Practicing Poor Sanitation in Rural India: A Population-Based Prospective Cohort Study.

    PubMed

    Padhi, Bijaya K; Baker, Kelly K; Dutta, Ambarish; Cumming, Oliver; Freeman, Matthew C; Satpathy, Radhanatha; Das, Bhabani S; Panigrahi, Pinaki

    2015-07-01

    The importance of maternal sanitation behaviour during pregnancy for birth outcomes remains unclear. Poor sanitation practices can promote infection and induce stress during pregnancy and may contribute to adverse pregnancy outcomes (APOs). We aimed to assess whether poor sanitation practices were associated with increased risk of APOs such as preterm birth and low birth weight in a population-based study in rural India. A prospective cohort of pregnant women (n = 670) in their first trimester of pregnancy was enrolled and followed until birth. Socio-demographic, clinical, and anthropometric factors, along with access to toilets and sanitation practices, were recorded at enrolment (12th week of gestation). A trained community health volunteer conducted home visits to ensure retention in the study and learn about study outcomes during the course of pregnancy. Unadjusted odds ratios (ORs) and adjusted odds ratios (AORs) and 95% confidence intervals for APOs were estimated by logistic regression models. Of the 667 women who were retained at the end of the study, 58.2% practiced open defecation and 25.7% experienced APOs, including 130 (19.4%) preterm births, 95 (14.2%) births with low birth weight, 11 (1.7%) spontaneous abortions, and six (0.9%) stillbirths. Unadjusted ORs for APOs (OR: 2.53; 95% CI: 1.72-3.71), preterm birth (OR: 2.36; 95% CI: 1.54-3.62), and low birth weight (OR: 2.00; 95% CI: 1.24-3.23) were found to be significantly associated with open defecation practices. After adjustment for potential confounders such as maternal socio-demographic and clinical factors, open defecation was still significantly associated with increased odds of APOs (AOR: 2.38; 95% CI: 1.49-3.80) and preterm birth (AOR: 2.22; 95% CI: 1.29-3.79) but not low birth weight (AOR: 1.61; 95% CI: 0.94-2.73). The association between APOs and open defecation was independent of poverty and caste. Even though we accounted for several key confounding factors in our estimates, the possibility

  15. Patients With Failed Prior Two-Stage Exchange Have Poor Outcomes After Further Surgical Intervention.

    PubMed

    Kheir, Michael M; Tan, Timothy L; Gomez, Miguel M; Chen, Antonia F; Parvizi, Javad

    2017-04-01

    Failure of 2-stage exchange arthroplasty for the management of periprosthetic joint infection (PJI) poses a major clinical challenge. There is a paucity of information regarding the outcomes of further surgical intervention in these patients. Thus, we aim to report the clinical outcomes of subsequent surgery for a failed prior 2-stage exchange arthroplasty. Our institutional database was used to identify 60 patients (42 knees and 18 hips), with a failed prior 2-stage exchange, who underwent further surgical intervention between 1998 and 2012, and had a minimum 2-year follow-up. A retrospective review was performed to extract relevant clinical information, including mortality, microbiology, and subsequent surgeries. Musculoskeletal Infection Society criteria were used to define PJI, and treatment success was defined using Delphi criteria. Irrigation and debridement (I&D) was performed after a failed 2-stage exchange in 61.7% of patients; 56.8% subsequently failed. Forty patients underwent an intended second 2-stage exchange; 6 cases required a spacer exchange. Reimplantation occurred only in 65% of cases, and 61.6% had infection controlled. The 14 cases that were not reimplanted resulted in 6 retained spacers, 5 amputations, 2 PJI-related mortalities, and 1 arthrodesis. Further surgical intervention after a failed prior 2-stage exchange arthroplasty has poor outcomes. Although I&D has a high failure rate, many patients who are deemed candidates for a second 2-stage exchange either do not undergo reimplantation or fail after reimplantation. The management of PJI clearly remains imperfect, and there is a dire need for further innovations that may improve the care of these patients. Copyright © 2016 Elsevier Inc. All rights reserved.

  16. Factors associated with poor functional outcome in bipolar disorder: sociodemographic, clinical, and neurocognitive variables.

    PubMed

    Sanchez-Moreno, J; Bonnin, C M; González-Pinto, A; Amann, B L; Solé, B; Balanzá-Martinez, V; Arango, C; Jiménez, E; Tabarés-Seisdedos, R; Garcia-Portilla, M P; Ibáñez, A; Crespo, J M; Ayuso-Mateos, J L; Martinez-Aran, A; Torrent, C; Vieta, E

    2018-05-03

    The current investigation aimed at studying the sociodemographic, clinical, and neuropsychological variables related to functional outcome in a sample of euthymic patients with bipolar disorder(BD) presenting moderate-severe levels of functional impairment. Two-hundred and thirty-nine participants with BD disorders and with Functioning Assessment Short Test(FAST) scores equal or above 18 were administered a clinical and diagnostic interview, and the administration of mood measure scales and a comprehensive neuropsychological battery. Analyses involved preliminary Pearson bivariate correlations to identify sociodemographic and clinical variables associated with the FAST total score. Regarding neuropsychological variables, a principal component analysis (PCA) was performed to group the variables in orthogonal factors. Finally, a hierarchical multiple regression was run. The best fitting model for the variables associated with functioning was a linear combination of gender, age, estimated IQ, Hamilton Depression Rating Scale (HAM-D), number of previous manic episodes, Factor 1 and Factor 2 extracted from the PCA. The model, including all these previous variables, explained up to 29.4% of the observed variance. Male gender, older age, lower premorbid IQ, subdepressive symptoms, higher number of manic episodes, and lower performance in verbal memory, working memory, verbal fluency, and processing speed were associated with lower functioning in patients with BD. © 2018 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

  17. Biomarkers, lactate, and clinical scores as outcome predictors in systemic poisons exposures.

    PubMed

    Lionte, C; Sorodoc, V; Tuchilus, C; Cimpoiesu, D; Jaba, E

    2017-07-01

    Acute exposure to systemic poisons represents an important challenge in clinical toxicology. We aimed to analyze the potential role of cardiac biomarkers, routine laboratory tests, and clinical scores as morbidity and in-hospital mortality predictors in patients intoxicated with various systemic poisons. We conducted a prospective study on adults acutely exposed to systemic poisons. We determined the PSS, Glasgow Coma Scale (GCS), and we performed electrocardiogram, laboratory tests, lactate and cardiac biomarkers (which were reassessed 4 h, respectively 6 h later). Of 120 patients included, 45% developed complications, 19.2% had a poor outcome, and 5% died. Multivariate logistic regression sustained lactate (odds ratio (OR) 1.58; confidence interval (CI) 95%: 0.97-2.59; p 0.066), MB isoenzyme of creatine kinase (6h-CKMB; OR 1.08; CI 95%: 1.02-1.16; p 0.018) as predictors for a poor outcome. A GCS < 10 (OR 0.113; CI 95%: 0.019-0.658; p 0.015) and 4h-lactate (OR 4.87; CI 95%: 0.79-29.82; p 0.087) predicted mortality after systemic poisons exposure. Receiver operating characteristic analysis showed that brain natriuretic peptide (area under the curve (AUC), 0.96; CI 95%: 0.92-0.99; p < 0.001), lactate (AUC, 0.91; CI 95%: 0.85-0.97; p < 0.001), and 6h-CKMB have good discriminatory capacity for predicting a poor outcome. In conclusion, these biomarkers, lactate, and GCS can be used to predict morbidity and mortality after systemic poisons exposure.

  18. Ford Class Aircraft Carrier: Poor Outcomes Are the Predictable Consequences of the Prevalent Acquisition Culture

    DTIC Science & Technology

    2015-10-01

    FORD CLASS AIRCRAFT CARRIER Poor Outcomes Are the Predictable Consequences of the Prevalent Acquisition Culture...2. REPORT TYPE 3. DATES COVERED 00-00-2015 to 00-00-2015 4. TITLE AND SUBTITLE Ford Class Aircraft Carrier: Poor Outcomes Are the Predictable...This Study The Navy set ambitious goals for the Ford -class program, including an array of new technologies and design features that were intended

  19. Poor outcome and death among youth, young adults, and midlife adults with eating disorders: an investigation of risk factors by age at assessment.

    PubMed

    Ackard, Diann M; Richter, Sara; Egan, Amber; Cronemeyer, Catherine

    2014-11-01

    Eating disorders (EDs) present across a broad age range, yet little is known about the characteristics and outcome of midlife patients compared to younger patients. Among patients seeking ED treatment who were stratified by age at initial assessment (IA), this study aimed to (1) discern sociodemographic and clinical differences, (2) determine outcome rates, and (3) identify predictors of poor outcome including death. Participants [219 females (12 years or older, 94.1% Caucasian) who completed outcome assessment and 31 known decedents] were stratified by age at IA (<18 as youth, 18-39 as young adult, and ≥40 years as midlife adult). Analyses of variance and chi-square tests identified group differences; ordered logistic regression with stepwise selection identified factors predicting outcome. Midlife adults were more significantly compromised at follow-up compared to youths and young adults, including psychological and physical quality of life, ineffectiveness, interpersonal concerns, and general psychological maladjustment. Midlife adults had the highest rates of poor outcome or death; good outcome was achieved by only 5.9% of midlife adult compared to 14.0% of young adult and 27.5% of youth patients. Older age at IA, alcohol and/or drug misuse, endocrine concerns, and absence of family ED history predicted poor outcome or death. Midlife adults seeking ED treatment have more complex medical and psychological concerns and poorer outcomes than youths and young adults; further exploration is needed to improve treatment outcome. Specialized treatment focusing on quality of life, comorbid medical concerns, interpersonal connection, and emotion regulation is encouraged. © 2014 Wiley Periodicals, Inc.

  20. Effects of Prophylactic Antiepileptic Drugs on Clinical Outcomes in Patients with a Good Clinical Grade Suffering from Aneurysmal Subarachnoid Hemorrhage

    PubMed Central

    Yoon, Seon Jin; Joo, Jin-Yang; Kim, Yong Bae; Hong, Chang-Ki

    2015-01-01

    Objective Routine use of prophylactic antiepileptic drugs (AED) has been debated. We retrospectively evaluated the effects of prophylactic AED on clinical outcomes in patients with a good clinical grade suffering from aneurysmal subarachnoid hemorrhage (aSAH). Materials and Methods Between September 2012 and December 2014, 84 patients who met the following criteria were included: (1) presence of a ruptured aneurysm; (2) Hunt-Hess grade 1, 2, or 3; and (3) without seizure presentation. Patients were divided into two groups; the AED group (n = 44) and the no AED group (n = 40). Clinical data and outcomes were compared between the two groups. Results Prophylactic AEDs were used more frequently in patients who underwent microsurgery (84.1%) compared to those who underwent endovascular surgery (15.9%, p < 0.001). Regardless of prophylactic AED use, seizure episodes were not observed during the six-month follow-up period. No statistical difference in clinical outcomes at discharge (p = 0.607) and after six months of follow-up (p = 0.178) were between the two groups. After six months, however, favorable outcomes in the no AED group tended to increase and poor outcomes tended to decrease. Conclusion No difference in the clinical outcomes and systemic complications at discharge and after six months of follow-up was observed between the two groups. However, favorable outcomes in the no AED group showed a slight increase after six months. These findings suggest that discontinuation of the current practice of using prophylactic AED might be recommended in patients with a good clinical grade. PMID:26526008

  1. Increased length of inpatient stay and poor clinical coding: audit of patients with diabetes

    PubMed Central

    Daultrey, Harriet; Gooday, Catherine; Dhatariya, Ketan

    2011-01-01

    Objectives People with diabetes stay in hospital for longer than those without diabetes for similar conditions. Clinical coding is poor across all specialties. Inpatients with diabetes often have unrecognized foot problems. We wanted to look at the relationships between these factors. Design A single day audit, looking at the prevalence of diabetes in all adult inpatients. Also looking at their feet to find out how many were high-risk or had existing problems. Setting A 998-bed university teaching hospital. Participants All adult inpatients. Main outcome measures (a) To see if patients with diabetes and foot problems were in hospital for longer than the national average length of stay compared with national data; (b) to see if there were people in hospital with acute foot problems who were not known to the specialist diabetic foot team; and (c) to assess the accuracy of clinical coding. Results We identified 110 people with diabetes. However, discharge coding data for inpatients on that day showed 119 people with diabetes. Length of stay (LOS) was substantially higher for those with diabetes compared to those without (± SD) at 22.39 (22.26) days, vs. 11.68 (6.46) (P < 0.001). Finally, clinical coding was poor with some people who had been identified as having diabetes on the audit, who were not coded as such on discharge. Conclusion Clinical coding – which is dependent on discharge summaries – poorly reflects diagnoses. Additionally, length of stay is significantly longer than previous estimates. The discrepancy between coding and diagnosis needs addressing by increasing the levels of awareness and education of coders and physicians. We suggest that our data be used by healthcare planners when deciding on future tariffs. PMID:22140609

  2. Poor outcome prediction by burst suppression ratio in adults with post-anoxic coma without hypothermia.

    PubMed

    Yang, Qinglin; Su, Yingying; Hussain, Mohammed; Chen, Weibi; Ye, Hong; Gao, Daiquan; Tian, Fei

    2014-05-01

    Burst suppression ratio (BSR) is a quantitative electroencephalography (qEEG) parameter. The purpose of our study was to compare the accuracy of BSR when compared to other EEG parameters in predicting poor outcomes in adults who sustained post-anoxic coma while not being subjected to therapeutic hypothermia. EEG was registered and recorded at least once within 7 days of post-anoxic coma onset. Electrodes were placed according to the international 10-20 system, using a 16-channel layout. Each EEG expert scored raw EEG using a grading scale adapted from Young and scored amplitude-integrated electroencephalography tracings, in addition to obtaining qEEG parameters defined as BSR with a defined threshold. Glasgow outcome scales of 1 and 2 at 3 months, determined by two blinded neurologists, were defined as poor outcome. Sixty patients with Glasgow coma scale score of 8 or less after anoxic accident were included. The sensitivity (97.1%), specificity (73.3%), positive predictive value (82.5%), and negative prediction value (95.0%) of BSR in predicting poor outcome were higher than other EEG variables. BSR1 and BSR2 were reliable in predicting death (area under the curve > 0.8, P < 0.05), with the respective cutoff points being 39.8% and 61.6%. BSR1 was reliable in predicting poor outcome (area under the curve  =  0.820, P < 0.05) with a cutoff point of 23.9%. BSR1 was also an independent predictor of increased risk of death (odds ratio  =  1.042, 95% confidence intervals: 1.012-1.073, P  =  0.006). BSR may be a better predictor in prognosticating poor outcomes in patients with post-anoxic coma who do not undergo therapeutic hypothermia when compared to other qEEG parameters.

  3. Should Schools Expect Poor Physical and Mental Health, Social Adjustment, and Participation Outcomes in Students with Disability?

    PubMed Central

    Vaz, Sharmila; Cordier, Reinie; Falkmer, Marita; Ciccarelli, Marina; Parsons, Richard; McAuliffe, Tomomi; Falkmer, Torbjorn

    2015-01-01

    The literature on whether students with disabilities have worse physical and mental health, social adjustment, and participation outcomes when compared to their peers without disabilities is largely inconclusive. While the majority of case control studies showed significantly worse outcomes for students with disabilities; the proportion of variance accounted for is rarely reported. The current study used a population cross-sectional approach to determine the classification ability of commonly used screening and outcome measures in determining the disability status. Furthermore, the study aimed to identify the variables, if any, that best predicted the presence of disability. Results of univariate discriminant function analyses suggest that across the board, the sensitivity of the outcome/screening tools to correctly identify students with a disability was 31.9% higher than the related Positive Predictive Value (PPV). The lower PPV and Positive Likelihood Ratio (LR+) scores suggest that the included measures had limited discriminant ability (17.6% to 40.3%) in accurately identifying students at-risk for further assessment. Results of multivariate analyses suggested that poor health and hyperactivity increased the odds of having a disability about two to three times, while poor close perceived friendship and academic competences predicted disability with roughly the same magnitude. Overall, the findings of the current study highlight the need for researchers and clinicians to familiarize themselves with the psychometric properties of measures, and be cautious in matching the function of the measures with their research and clinical needs. PMID:25965845

  4. Should schools expect poor physical and mental health, social adjustment, and participation outcomes in students with disability?

    PubMed

    Vaz, Sharmila; Cordier, Reinie; Falkmer, Marita; Ciccarelli, Marina; Parsons, Richard; McAuliffe, Tomomi; Falkmer, Torbjorn

    2015-01-01

    The literature on whether students with disabilities have worse physical and mental health, social adjustment, and participation outcomes when compared to their peers without disabilities is largely inconclusive. While the majority of case control studies showed significantly worse outcomes for students with disabilities; the proportion of variance accounted for is rarely reported. The current study used a population cross-sectional approach to determine the classification ability of commonly used screening and outcome measures in determining the disability status. Furthermore, the study aimed to identify the variables, if any, that best predicted the presence of disability. Results of univariate discriminant function analyses suggest that across the board, the sensitivity of the outcome/screening tools to correctly identify students with a disability was 31.9% higher than the related Positive Predictive Value (PPV). The lower PPV and Positive Likelihood Ratio (LR+) scores suggest that the included measures had limited discriminant ability (17.6% to 40.3%) in accurately identifying students at-risk for further assessment. Results of multivariate analyses suggested that poor health and hyperactivity increased the odds of having a disability about two to three times, while poor close perceived friendship and academic competences predicted disability with roughly the same magnitude. Overall, the findings of the current study highlight the need for researchers and clinicians to familiarize themselves with the psychometric properties of measures, and be cautious in matching the function of the measures with their research and clinical needs.

  5. Positive Outcomes from Poor Starts: Predictors of Dropping Back In

    ERIC Educational Resources Information Center

    Hill, Lauren E.; Jepsen, Christopher

    2007-01-01

    A vast body of research finds an association between missteps taken during the teen years (such as motherhood or dropping out of high school) and poor economic and educational outcomes. However, youth who take major missteps as teens often have subsequent success in school or the labor market. This paper attempts to draw lessons from youth who…

  6. Clinical Presentation and Outcome of Patients With Optic Pathway Glioma.

    PubMed

    Robert-Boire, Viviane; Rosca, Lorena; Samson, Yvan; Ospina, Luis H; Perreault, Sébastien

    2017-10-01

    Optic pathway gliomas (OPGs) occur sporadically or in patients with neurofibromatosis type 1 (NF1). The purpose of this study was to evaluate the clinical presentation at diagnosis and at progression of patients with OPGs. We conducted a chart review of patients with OPGs diagnosed in a single center over a period of 15 years. Demographic data including age, sex, NF1 status, clinical presentation, and outcome were collected. Of the 40 patients who were identified, 23 had sporadic tumors (57.5%) and 17 had NF1-related tumors (42.5%). Among the children with NF1, there was a significant overrepresentation of girls (82.3%) (P = 0.02), while among the children without NF1, there were slightly more boys (56.5%) than girls (43.5%). The presence of nystagmus was strongly associated with sporadic optic pathway gliomas. Poor visual outcome was related to tumor affecting both optic pathways, hydrocephalus at diagnosis, and optic nerve atrophy. Of the 40 patients, five died of OPG complications (12.5%) and all had sporadic tumors. Our cohort is one of the largest with OPGs and a detailed description of the clinical presentation both at diagnosis and at progression. We observed a significant difference between sporadic and NF1 optic pathway gliomas in terms of demographics, clinical presentation, and outcome. Copyright © 2017 Elsevier Inc. All rights reserved.

  7. Muscle Mass Depletion Associated with Poor Outcome of Sepsis in the Emergency Department.

    PubMed

    Lee, YoonJe; Park, Hyun Kyung; Kim, Won Young; Kim, Myung Chun; Jung, Woong; Ko, Byuk Sung

    2018-05-08

    Muscle mass depletion has been suggested to predict morbidity and mortality in various diseases. However, it is not well known whether muscle mass depletion is associated with poor outcome in sepsis. We hypothesized that muscle mass depletion is associated with poor outcome in sepsis. Retrospective observational study was conducted in an emergency department during a 9-year period. Medical records of 627 patients with sepsis were reviewed. We divided the patients into 2 groups according to 28-day mortality and compared the presence of muscle mass depletion assessed by the cross-sectional area of the psoas muscle at the level of the third lumbar vertebra on abdomen CT scans. Univariate and multivariate logistic regression analyses were conducted to examine the association of scarcopenia on the outcome of sepsis. A total of 274 patients with sepsis were finally included in the study: 45 (16.4%) did not survive on 28 days and 77 patients (28.1%) were identified as having muscle mass depletion. The presence of muscle mass depletion was independently associated with 28-day mortality on multivariate logistic analysis (OR 2.79; 95% CI 1.35-5.74, p = 0.01). Muscle mass depletion evaluated by CT scan was associated with poor outcome of sepsis patients. Further studies on the appropriateness of specific treatment for muscle mass depletion with sepsis are needed. © 2018 S. Karger AG, Basel.

  8. Outcomes of tibial endovascular intervention in patients with poor pedal runoff.

    PubMed

    Baer-Bositis, Hallie E; Hicks, Taylor D; Haidar, Georges M; Sideman, Matthew J; Pounds, Lori L; Davies, Mark G

    2018-06-01

    Tibial interventions for critical limb ischemia are now commonplace. The aim of this study was to examine the impact of pedal runoff on patient-centered outcomes after tibial endovascular intervention. A database of patients undergoing lower extremity endovascular interventions at a single urban academic medical center between 2006 and 2016 was retrospectively queried. Patients with critical ischemia (Rutherford 5 and 6) were identified. Preintervention angiograms were reviewed in all cases to assess pedal runoff. Each dorsalis pedis, lateral plantar, and medial plantar artery was assigned a score according to the reporting standards of the Society for Vascular Surgery (0, no stenosis >20%; 1, 21%-49% stenosis; 2, 50%-99% stenosis; 2.5, half or less of the vessel length occluded; 3, more than half the vessel length occluded). A foot score (dorsalis pedis + medial plantar + lateral plantar + 1) was calculated for each foot (1-10). Two runoff score groups were identified: good vs poor, <7 and ≥7, respectively. Patient-oriented outcomes of clinical efficacy (absence of recurrent symptoms, maintenance of ambulation, and absence of major amputation), amputation-free survival (survival without major amputation), and freedom from major adverse limb events (above-ankle amputation of the index limb or major reintervention [new bypass graft, jump/interposition graft revision]) were evaluated. There were 1134 patients (56% male; average age, 59 years) who underwent tibial intervention for critical ischemia, with a mean of two vessels treated per patient and a mean pedal runoff score of 6 (47% had a runoff score ≥7). Overall major adverse cardiac events were equivalent at 30 days after the procedure in both groups. At 5 years, vessels with compromised runoff (score ≥7) had significantly lower ulcer healing (25% ± 3% vs 73% ± 4%, mean ± standard error of the mean [SEM]) and a lower 5-year limb salvage rate (45% ± 6% vs 69% ± 4%, mean ± SEM) compared

  9. Risk of Adverse Pregnancy Outcomes among Women Practicing Poor Sanitation in Rural India: A Population-Based Prospective Cohort Study

    PubMed Central

    Padhi, Bijaya K.; Baker, Kelly K.; Dutta, Ambarish; Cumming, Oliver; Freeman, Matthew C.; Satpathy, Radhanatha; Das, Bhabani S.; Panigrahi, Pinaki

    2015-01-01

    Background The importance of maternal sanitation behaviour during pregnancy for birth outcomes remains unclear. Poor sanitation practices can promote infection and induce stress during pregnancy and may contribute to adverse pregnancy outcomes (APOs). We aimed to assess whether poor sanitation practices were associated with increased risk of APOs such as preterm birth and low birth weight in a population-based study in rural India. Methods and Findings A prospective cohort of pregnant women (n = 670) in their first trimester of pregnancy was enrolled and followed until birth. Socio-demographic, clinical, and anthropometric factors, along with access to toilets and sanitation practices, were recorded at enrolment (12th week of gestation). A trained community health volunteer conducted home visits to ensure retention in the study and learn about study outcomes during the course of pregnancy. Unadjusted odds ratios (ORs) and adjusted odds ratios (AORs) and 95% confidence intervals for APOs were estimated by logistic regression models. Of the 667 women who were retained at the end of the study, 58.2% practiced open defecation and 25.7% experienced APOs, including 130 (19.4%) preterm births, 95 (14.2%) births with low birth weight, 11 (1.7%) spontaneous abortions, and six (0.9%) stillbirths. Unadjusted ORs for APOs (OR: 2.53; 95% CI: 1.72–3.71), preterm birth (OR: 2.36; 95% CI: 1.54–3.62), and low birth weight (OR: 2.00; 95% CI: 1.24–3.23) were found to be significantly associated with open defecation practices. After adjustment for potential confounders such as maternal socio-demographic and clinical factors, open defecation was still significantly associated with increased odds of APOs (AOR: 2.38; 95% CI: 1.49–3.80) and preterm birth (AOR: 2.22; 95% CI: 1.29–3.79) but not low birth weight (AOR: 1.61; 95% CI: 0.94–2.73). The association between APOs and open defecation was independent of poverty and caste. Even though we accounted for several key

  10. Association Between Malnutrition and Clinical Outcomes in the Intensive Care Unit: A Systematic Review [Formula: see text].

    PubMed

    Lew, Charles Chin Han; Yandell, Rosalie; Fraser, Robert J L; Chua, Ai Ping; Chong, Mary Foong Fong; Miller, Michelle

    2017-07-01

    Malnutrition is associated with poor clinical outcomes among hospitalized patients. However, studies linking malnutrition with poor clinical outcomes in the intensive care unit (ICU) often have conflicting findings due in part to the inappropriate diagnosis of malnutrition. We primarily aimed to determine whether malnutrition diagnosed by validated nutrition assessment tools such as the Subjective Global Assessment (SGA) or Mini Nutritional Assessment (MNA) is independently associated with poorer clinical outcomes in the ICU and if the use of nutrition screening tools demonstrate a similar association. PubMed, CINAHL, Scopus, and Cochrane Library were systematically searched for eligible studies. Search terms included were synonyms of malnutrition, nutritional status, screening, assessment, and intensive care unit. Eligible studies were case-control or cohort studies that recruited adults in the ICU; conducted the SGA, MNA, or used nutrition screening tools before or within 48 hours of ICU admission; and reported the prevalence of malnutrition and relevant clinical outcomes including mortality, length of stay (LOS), and incidence of infection (IOI). Twenty of 1168 studies were eligible. The prevalence of malnutrition ranged from 38% to 78%. Malnutrition diagnosed by nutrition assessments was independently associated with increased ICU LOS, ICU readmission, IOI, and the risk of hospital mortality. The SGA clearly had better predictive validity than the MNA. The association between malnutrition risk determined by nutrition screening was less consistent. Malnutrition is independently associated with poorer clinical outcomes in the ICU. Compared with nutrition assessment tools, the predictive validity of nutrition screening tools were less consistent.

  11. Poor nutritional status of older subacute patients predicts clinical outcomes and mortality at 18 months of follow-up.

    PubMed

    Charlton, K; Nichols, C; Bowden, S; Milosavljevic, M; Lambert, K; Barone, L; Mason, M; Batterham, M

    2012-11-01

    Older malnourished patients experience increased surgical complications and greater morbidity compared with their well-nourished counterparts. This study aimed to assess whether nutritional status at hospital admission predicted clinical outcomes at 18 months follow-up. A retrospective analysis of N=2076 patient admissions (65+ years) from two subacute hospitals, New South Wales, Australia. Analysis of outcomes at 18 months, according to nutritional status at index admission, was performed in a subsample of n = 476. Nutritional status was determined within 72 h of admission using the Mini Nutritional Assessment (MNA). Outcomes, obtained from electronic patient records, included hospital readmission rate, total Length of Stay (LOS), change in level of care at discharge and mortality. Survival analysis, using a Cox proportional hazards model, included age, sex, Major Disease Classification, mobility and LOS at index admission as covariates. At baseline, 30% of patients were malnourished and 53% were at risk of malnutrition. LOS was higher in malnourished and at risk, compared with well-nourished patients (median (interquartile range): 34 (21, 58); 26 (15, 41); 20 (14, 26) days, respectively; P<0.001). Hazard rate for death in the malnourished group is 3.41 (95% confidence interval: 1.07-10.87; P = 0.038) times the well-nourished group. Discharge to a higher level of residential care was 33.1%, 16.9% and 4.9% for malnourished, at-risk and well-nourished patients, respectively; P ≤ 0.001). Malnutrition in elderly subacute patients predicts adverse clinical outcomes and identifies a need to target this population for nutritional intervention following hospital discharge.

  12. Association between poor sleep, fatigue, and safety outcomes in Emergency Medical Services providers

    PubMed Central

    Patterson, P. Daniel; Weaver, Matthew D.; Frank, Rachel C.; Warner, Charles W.; Martin-Gill, Christian; Guyette, Francis X.; Fairbanks, Rollin J.; Hubble, Michael W.; Songer, Thomas J.; Callaway, Clifton W.; Kelsey, Sheryl F.; Hostler, David

    2011-01-01

    Objective To determine the association between poor sleep quality, fatigue, and self-reported safety outcomes among Emergency Medical Services (EMS) workers. Methods We used convenience sampling of EMS agencies and a cross-sectional survey design. We administered the 19-item Pittsburgh Sleep Quality Index (PSQI), 11-item Chalder Fatigue Questionnaire (CFQ), and 44-item EMS Safety Inventory (EMS-SI) to measure sleep quality, fatigue, and safety outcomes, respectively. We used a consensus process to develop the EMS-SI, which was designed to capture three composite measurements of EMS worker injury, medical errors and adverse events (AE), and safety compromising behaviors. We used hierarchical logistic regression to test the association between poor sleep quality, fatigue, and three composite measures of EMS worker safety outcomes. Results We received 547 surveys from 30 EMS agencies (a 35.6% mean agency response rate). The mean PSQI score exceeded the benchmark for poor sleep (6.9, 95%CI 6.6, 7.2). Greater than half of respondents were classified as fatigued (55%, 95%CI 50.7, 59.3). Eighteen percent of respondents reported an injury (17.8%, 95%CI 13.5, 22.1), forty-one percent a medical error or AE (41.1%, 95%CI 36.8, 45.4), and 89% (95%CI 87, 92) safety compromising behaviors. After controlling for confounding, we identified 1.9 greater odds of injury (95%CI 1.1, 3.3), 2.2 greater odds of medical error or AE (95%CI 1.4, 3.3), and 3.6 greater odds of safety compromising behavior (95%CI 1.5, 8.3) among fatigued respondents versus non-fatigued respondents. Conclusions In this sample of EMS workers, poor sleep quality and fatigue is common. We provide preliminary evidence of an association between sleep quality, fatigue, and safety outcomes. PMID:22023164

  13. Elevated serum creatinine at baseline predicts poor outcome in patients receiving cardiac resynchronization therapy.

    PubMed

    Shalaby, Alaa; El-Saed, Aiman; Voigt, Andrew; Albany, Constantine; Saba, Samir

    2008-05-01

    Renal insufficiency is recognized as a predictor of mortality and poor outcome in heart failure patients. We sought to study the impact of baseline serum creatinine on subsequent outcome in cardiac resynchronization therapy (CRT) recipients. We retrospectively reviewed hospital records of all CRT recipients at Pittsburgh Veterans Affairs (VA) Healthcare System (2003-2005) and University of Pittsburgh Medical Center (2004). We recorded clinical characteristics at the time of implantation including demographics, New York Heart Association (NYHA) functional class, ejection fraction, QRS duration, cardiomyopathy etiology, medical history, medication use, and serum creatinine. Mortality alone and mortality combined with heart failure hospitalization were the study endpoints. Out of the 330 patients studied, a total of 66 (20.0%) patients died over a mean follow-up duration of 19.7 +/- 9.0 months (range 1-44). The cohort was studied by three creatinine tertiles (0.6-1.0, 1.1-1.3, 1.4-3.0 mg/dL). Both study endpoints were observed more frequently in patients in the highest creatinine tertile compared to others (28.7% vs 14.0%, P = 0.008 for death and 41.6% vs 21.5%, P = 0.001 for the combined endpoint). High creatinine remained an independent predictor of mortality (hazard ratio [HR] 1.89, 95% confidence interval [CI] 1.06-3.39, P = 0.032) and the combined endpoint (HR 1.94, 95% CI 1.20-3.13, P = 0.007) in multivariate adjusted models. Studied as a continuous variable, increase in creatinine level by 0.1 mg/dL was associated with an 11% increase in mortality risk and a 7% increase in the combined endpoint. In an unselected cohort of CRT recipients, the baseline creatinine was found to predict worse survival and poor outcome over a modest follow-up duration.

  14. Factors determining poor prognostic outcomes following diabetic hand infections

    PubMed Central

    Ince, Bilsev; Dadaci, Mehmet; Arslan, Abdullah; Altuntas, Zeynep; Evrenos, Mustafa Kursat; Fatih Karsli, Mehmet

    2015-01-01

    Background and Objective: Hand ulcers are seen in a small percentage of patients with diabetes. The predisposing factors of diabetic hand varies between different countries. However, the effects of predisposing factors on prognosis are not clear in diabetic hand infections. In this study, our aim was to determine the effects of predisposing factors on poor prognostic outcomes in patients with diabetes mellitus. Methods: Thirty-four patients with diabetes mellitus who were treated and followed up for a hand infection in between 2008 and 2014 were investigated retrospectively. Patients were evaluated according to predisposing factors defined in the literature that included disease period, age, gender, admission time, presence of neuropathy, smoking habits, HbA1c levels at admission time, peripheral vascular disease, end-stage renal disease (ESRD), and trauma. Death and minor/major amputation cases during treatment were defined as poor prognosis. Results: Patients who had ESRD, peripheral neuropathy, or an HbA1c level greater than 10% had significantly higher amputation rates. Conclusions: Peripheral neuropathy, ESRD, and HbA1c levels greater than 10% at the time of admission were determined as poor prognosis criteria for diabetic hand treatment. PMID:26150838

  15. Decreased expression of RNA interference machinery, Dicer and Drosha, is associated with poor outcome in ovarian cancer patients

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

    Merritt, William M.; Lin, Yvonne G.; Han, Liz Y.

    2008-05-06

    The clinical and functional significance of RNA interference (RNAi) machinery, Dicer and Drosha, in ovarian cancer is not known and was examined. Dicer and Drosha expression was measured in ovarian cancer cell lines (n=8) and invasive epithelial ovarian cancer specimens (n=111) and correlated with clinical outcome. Validation was performed with previously published cohorts of ovarian, breast, and lung cancer patients. Anti-Galectin-3 siRNA and shRNA transfections were used for in vitro functional studies. Dicer and Drosha mRNA and protein levels were decreased in 37% to 63% of ovarian cancer cell lines and in 60% and 51% of human ovarian cancer specimens,more » respectively. Low Dicer was significantly associated with advanced tumor stage (p=0.007), and low Drosha with suboptimal surgical cytoreduction (p=0.02). Tumors with both high Dicer and Drosha were associated with increased median patient survival (>11 years vs. 2.66 years for other groups; p<0.001). In multivariate analysis, high Dicer (HR=0.48; p=0.02), high-grade histology (HR=2.46; p=0.03), and poor chemoresponse (HR=3.95; p<0.001) were identified as independent predictors of disease-specific survival. Findings of poor clinical outcome with low Dicer expression were validated in separate cohorts of cancer patients. Galectin-3 silencing with siRNA transfection was superior to shRNA in cell lines with low Dicer (78-95% vs. 4-8% compared to non-targeting sequences), and similar in cell lines with high Dicer. Our findings demonstrate the clinical and functional impact of RNAi machinery alterations in ovarian carcinoma and support the use of siRNA constructs that do not require endogenous Dicer and Drosha for therapeutic applications.« less

  16. Clinical Outcomes following median to radial nerve transfers

    PubMed Central

    Ray, Wilson Z.; Mackinnon, Susan E.

    2010-01-01

    Purpose In this study the authors evaluate the clinical outcomes in patients with radial nerve palsy who underwent nerve transfers utilizing redundant fascicles of median nerve (innervating the flexor digitorum superficialis and flexor carpi radialis muscles) to the posterior interosseous nerve and the nerve to the extensor carpi radialis brevis. Methods A retrospective review of the clinical records of 19 patients with radial nerve injuries who underwent nerve transfer procedures using the median nerve as a donor nerve were included. All patients were evaluated using the Medical Research Council (MRC) grading system. Results The mean age of patients was 41 years (range 17 – 78 years). All patients received at least 12 months of follow-up (20.3 ± 5.8 months). Surgery was performed at a mean of 5.7 ± 1.9 months post-injury. Post-operative functional evaluation was graded according to the following scale: grades MRC 0/5 - MRC 2/5 were considered poor outcomes, while MRC of 3/5 was a fair result, MRC grade 4/5 was a good result, and grade 4+/5 was considered an excellent outcome. Seventeen patients (89%) had a complete radial nerve palsy while two patients (11%) had intact wrist extension but no finger or thumb extension. Post-operatively all patients except one had good to excellent recovery of wrist extension. Twelve patients recovered good to excellent finger and thumb extension, two patients had fair recovery, five patients had a poor recovery. Conclusions The radial nerve is a commonly injured nerve, causing significant morbidity in affected patients. The median nerve provides a reliable source of donor nerve fascicles for radial nerve reinnervation. This transfer was first performed in 1999 and evolved over the subsequent decade. The important nuances of both surgical technique and motor re-education critical for to the success of this transfer have been identified and are discussed. PMID:21168979

  17. Specific Infectious Organisms Associated With Poor Outcomes in Treatment for Hip Periprosthetic Infection.

    PubMed

    Cunningham, Daniel J; Kavolus, Joseph J; Bolognesi, Michael P; Wellman, Samuel S; Seyler, Thorsten M

    2017-06-01

    Periprosthetic hip infection treatment remains a significant challenge for orthopedics. Some studies have suggested that methicillin resistance and gram-negative organism type are associated with increased treatment failure. The aim of this research is to determine if specific organisms were associated with poor outcomes in treatment for hip periprosthetic infection. Records were reviewed of all patients between 2005 and 2015 who underwent treatment for infected partial or total hip arthroplasty. Characteristics of each patient's treatment course were determined including baseline characteristics, infecting organism(s), infection status at final follow-up, surgeries for infection, and time in hospital. Baseline characteristics and organisms that were associated with clinical outcomes in univariate analysis were incorporated into multivariable outcomes models. When compared with patients infected with other organism(s), patients infected with the following organisms had significantly decreased infection-free rates: Pseudomonas, methicillin-resistant Staphylococcus aureus (MRSA), and Proteus. Infection with certain organisms was associated with 1.13-2.58 additional surgeries: methicillin-sensitive S aureus, coagulase-negative Staphylococcus, MRSA, Pseudomonas, Peptostreptococcus, Klebsiella, Candida, diphtheroids, Propionibacterium acnes, and Proteus species. Specific organisms were associated with 8.56-24.54 additional days in hospital for infection: methicillin-sensitive S aureus, coagulase-negative Staphylococcus, Proteus, MRSA, Enterococcus, Pseudomonas, Klebsiella, beta-hemolytic Streptococcus, and diphtheroids. Higher comorbidity score was also associated with greater length of hospitalization. MRSA, Pseudomonas, and Proteus were associated with all 3 outcomes of lower infection-free rate, more surgery, and more time in hospital in treatment for hip periprosthetic infection. Organism-specific outcome information may help individualize patient

  18. Low levels of Stat5a protein in breast cancer are associated with tumor progression and unfavorable clinical outcomes

    PubMed Central

    2012-01-01

    Introduction Signal transducer and activator of transcripton-5a (Stat5a) and its close homologue, Stat5b, mediate key physiological effects of prolactin and growth hormone in mammary glands. In breast cancer, loss of nuclear localized and tyrosine phosphorylated Stat5a/b is associated with poor prognosis and increased risk of antiestrogen therapy failure. Here we quantify for the first time levels of Stat5a and Stat5b over breast cancer progression, and explore their potential association with clinical outcome. Methods Stat5a and Stat5b protein levels were quantified in situ in breast-cancer progression material. Stat5a and Stat5b transcript levels in breast cancer were correlated with clinical outcome in 936 patients. Stat5a protein was further quantified in four archival cohorts totaling 686 patients with clinical outcome data by using multivariate models. Results Protein levels of Stat5a but not Stat5b were reduced in primary breast cancer and lymph node metastases compared with normal epithelia. Low tumor levels of Stat5a but not Stat5b mRNA were associated with poor prognosis. Experimentally, only limited overlap between Stat5a- and Stat5b-modulated genes was found. In two cohorts of therapy-naïve, node-negative breast cancer patients, low nuclear Stat5a protein levels were an independent marker of poor prognosis. Multivariate analysis of two cohorts treated with antiestrogen monotherapy revealed that low nuclear Stat5a levels were associated with a more than fourfold risk of unfavorable outcome. Conclusions Loss of Stat5a represents a new independent marker of poor prognosis in node-negative breast cancer and may be a predictor of response to antiestrogen therapy if validated in randomized clinical trials. PMID:23036105

  19. Usefulness of Midregional Proadrenomedullin to Predict Poor Outcome in Patients with Community Acquired Pneumonia

    PubMed Central

    Gordo-Remartínez, Susana; Sevillano-Fernández, José A.; Álvarez-Sala, Luis A.; Andueza-Lillo, Juan A.; de Miguel-Yanes, José M.

    2015-01-01

    Background midregional proadrenomedullin (MR-proADM) is a prognostic biomarker in patients with community-acquired pneumonia (CAP). We sought to confirm whether MR-proADM added to Pneumonia Severity Index (PSI) improves the potential prognostic value of PSI alone, and tested to what extent this combination could be useful in predicting poor outcome of patients with CAP in an Emergency Department (ED). Methods Consecutive patients diagnosed with CAP were enrolled in this prospective, single-centre, observational study. We analyzed the ability of MR-proADM added to PSI to predict poor outcome using receiver operating characteristic (ROC) curves, logistic regression and risk reclassification and comparing it with the ability of PSI alone. The primary outcome was “poor outcome”, defined as the incidence of an adverse event (ICU admission, hospital readmission, or mortality at 30 days after CAP diagnosis). Results 226 patients were included; 33 patients (14.6%) reached primary outcome. To predict primary outcome the highest area under curve (AUC) was found for PSI (0.74 [0.64-0.85]), which was not significantly higher than for MR-proADM (AUC 0.72 [0.63-0.81, p > 0.05]). The combination of PSI and MR-proADM failed to improve the predictive potential of PSI alone (AUC 0.75 [0.65-0.85, p=0.56]). Ten patients were appropriately reclassified when the combined PSI and MR-proADM model was used as compared with the model of PSI alone. Net reclassification improvement (NRI) index was statistically significant (7.69%, p = 0.03) with an improvement percentage of 3.03% (p = 0.32) for adverse event, and 4.66% (P = 0.02) for no adverse event. Conclusion MR-proADM in combination with PSI may be helpful in individual risk stratification for short-term poor outcome of CAP patients, allowing a better reclassification of patients compared with PSI alone. PMID:26030588

  20. Primary tumor location predicts poor clinical outcome with cetuximab in RAS wild-type metastatic colorectal cancer.

    PubMed

    Kim, Dalyong; Kim, Sun Young; Lee, Ji Sung; Hong, Yong Sang; Kim, Jeong Eun; Kim, Kyu-Pyo; Kim, Jihun; Jang, Se Jin; Yoon, Young-Kwang; Kim, Tae Won

    2017-11-23

    In metastatic colorectal cancer, the location of the primary tumor has been suggested to have biological significance. In this study, we investigated whether primary tumor location affects cetuximab efficacy in patients with RAS wild-type metastatic colorectal cancer. Genotyping by the SequenomMassARRAY technology platform (OncoMap) targeting KRAS, NRAS, PIK3CA, and BRAF was performed in tumors from 307 patients who had been given cetuximab as salvage treatment. Tumors with mutated RAS (KRAS or NRAS; n = 127) and those with multiple primary location (n = 10) were excluded. Right colon cancer was defined as a tumor located in the proximal part to splenic flexure. A total of 170 patients were included in the study (right versus left, 23 and 147, respectively). Patients with right colon cancer showed more mutated BRAF (39.1% vs. 5.4%), mutated PIK3CA (13% vs. 1.4%), poorly differentiated tumor (17.4% vs. 3.4%), and peritoneal involvement (26.1% vs. 8.8%) than those with left colon and rectal cancer. Right colon cancer showed poorer progression-free survival (2.0 vs.5.0 months, P = 0.002) and overall survival (4.1 months and 13.0 months, P < 0.001) than the left colon and rectal cancer. By multivariable analysis, BRAF mutation, right colon primary, poorly differentiated histology, and peritoneal involvement were associated with risk of death. In RAS wild-type colon cancer treated with cetuximab as salvage treatment, right colon primary was associated with poorer survival outcomes than left colon and rectal cancer.

  1. Poor short term outcome with a metal-on-metal total hip arthroplasty.

    PubMed

    Levy, Yadin D; Ezzet, Kace A

    2013-08-01

    Metal-on-metal (MoM) bearings for total hip arthroplasty (THA) have come under scrutiny with reports of high failure rates. Clinical outcome studies with several commercially available MoM THA bearings remain unreported. We evaluated 78 consecutive MoM THAs from a single manufacturer in 68 patients. Sixty-six received cobalt-chrome (CoCr) monoblock and 12 received modular titanium acetabular cups with internal CoCr liners. Femoral components were titanium with modular necks. At average 2.1 years postoperatively, 12 THAs (15.4%) demonstrated aseptic failure (10 revisions, 2 revision recommended). All revised hips demonstrated capsular necrosis with positive histology reaction for aseptic lymphocytic vasculitis-associated lesions/adverse local tissue reactions. Prosthetic instability following revision surgery was relatively common. Female gender was a strong risk factor for failure, though smaller cups were not. Both monoblock and modular components fared poorly. Corrosion was frequently observed around the proximal and distal end of the modular femoral necks. Copyright © 2013 Elsevier Inc. All rights reserved.

  2. Autonomic Dysfunction Predicts Clinical Outcomes After Acute Ischemic Stroke: A Prospective Observational Study.

    PubMed

    Xiong, Li; Tian, Ge; Leung, Howan; Soo, Yannie O Y; Chen, Xiangyan; Ip, Vincent H L; Mok, Vincent C T; Chu, Winnie C W; Wong, Ka Sing; Leung, Thomas W H

    2018-01-01

    Central autonomic dysfunction increases stroke morbidity and mortality. We aimed to investigate whether poststroke autonomic dysfunction graded by Ewing battery can predict clinical outcome. In this prospective observational study, we assessed autonomic function of ischemic stroke patients within 7 days from symptom onset by Ewing battery. On the basis of the magnitude of autonomic dysfunction, we stratified patients into significant (definite, severe, or atypical) or minor (normal or early) autonomic function impairment groups and correlated the impairment with the 3-month modified Rankin Scale score (good outcome: modified Rankin Scale score 0≈2; poor outcome: modified Rankin Scale score 3≈6). Among the 150 patients enrolled (mean age, 66.4±9.9 years; 70.7% males), minor autonomic dysfunction was identified in 36 patients (24.0%), and significant autonomic dysfunction was identified in 114 patients (76.0%) based on Ewing battery. In 3 months, a poor functional outcome was found in 32.5% of significant group patients compared with 13.9% in the minor group ( P =0.031). Crude odds ratios of the magnitude of autonomic dysfunction and 3-month unfavorable functional outcome after acute ischemic stroke were 2.979 (95% confidence interval, 1.071-8.284; P =0.036). After adjusting for confounding variables with statistical significance between the 2 functional outcome subgroups identified in univariate analysis (including sex and National Institutes of Health Stroke Scale score on admission), the magnitude of autonomic dysfunction still independently predicted an unfavorable outcome, with an odds ratio of 3.263 (95% confidence interval, 1.141-9.335; P =0.027). Autonomic dysfunction gauged by Ewing battery predicts poor functional outcome after acute ischemic stroke. © 2017 American Heart Association, Inc.

  3. Clinical outcomes for young people with screening-detected and clinically-diagnosed rheumatic heart disease in Fiji.

    PubMed

    Engelman, Daniel; Mataika, Reapi L; Ah Kee, Maureen; Donath, Susan; Parks, Tom; Colquhoun, Samantha M; Carapetis, Jonathan R; Kado, Joseph H; Steer, Andrew C

    2017-08-01

    Echocardiographic screening is under consideration as a disease control strategy for rheumatic heart disease (RHD). However, clinical outcomes of young people with screening-detected RHD are unknown. We aimed to describe the outcomes for a cohort with screening-detected RHD, in comparison to patients with clinically-diagnosed RHD. A retrospective cohort study included all young people with screening-detected RHD in the Central Division of Fiji in the primary cohort. Screen-negative and clinically-diagnosed comparison groups were matched 1:1 to the primary cohort. Data were collected on mortality, clinical complications and healthcare utilisation from the electronic and paper health records and existing databases. Seventy participants were included in each group. Demographic characteristics of the groups were similar (median age 11years, 69% female, median follow-up 7years). There were nine (12.9%) RHD-related deaths in the clinically-diagnosed group and one (1.4%) in the screening-detected group (Incident Rate Ratio: 9.6, 95% CI 1.3-420.6). Complications of RHD were observed in 39 (55.7%) clinically-diagnosed cases, four (20%) screening-detected cases and one (1.4%) screen-negative case. There were significant differences in the cumulative complication curves of the groups (p<0.001). Rates of admission and surgery were highest in the clinically-diagnosed group, and higher in the screening-detected than screen-negative group. Young people with screening-detected RHD have worse health outcomes than screen-negative cases in Fiji. The prognosis of clinically-diagnosed RHD remains poor, with very high mortality and complication rates. Further studies in other settings will inform RHD screening policy. Comprehensive control strategies are required for disease prevention. Copyright © 2017 Elsevier B.V. All rights reserved.

  4. Effects of anticoagulant therapy on pregnancy outcomes in patients with thrombophilia and previous poor obstetric history.

    PubMed

    Mutlu, Ilknur; Mutlu, Mehmet Firat; Biri, Aydan; Bulut, Berk; Erdem, Mehmet; Erdem, Ahmet

    2015-04-01

    This study investigates the effects of anticoagulant therapy on pregnancy outcomes in 204 patients with thrombophilia and previous poor obstetric outcomes. Patients with poor obstetric history (pre-eclampsia, intrauterine growth retardation, fetal death, placental abruption, recurrent pregnancy loss) and having hereditary thrombophilia were included in this study. Poor obstetric outcomes were observed more frequently in patients who had not taken anticogulant therapy compared with treated group. Live birth rate, gestational age at birth and Apgar scores were significantly higher in the treated group when compared with the untreated group. There were no significant differences in terms of birthweight, mode of delivery and admission rates to the neonatal intensive care unit (NICU). Low-molecular-weight heparin (LMWH) plus acetylsalicylic acid (ASA) had higher gestational age at birth, Apgar scores, live birth rate and a lower abortion rates when compared with controls; in contrast, no significant difference was observed in terms of birthweight, mode of delivery, obstetric complications and admission rates to NICU. There were no significant differences between control group and both LMWH only and ASA only groups in terms of gestational age at birth, Apgar scores, birthweight, mode of delivery, obstetric complications and admission rates to NICU. Only LMWH group had higher live birth rate as compared with control group. The use of only ASA did not seem to affect the perinatal complication rates and outcomes. In conclusion, anticoagulant therapy with both LMWH and ASA seems to provide better obstetric outcomes in pregnant women with thrombophilia and previous poor obstetric outcomes.

  5. Poor response cycles: when should we cancel? Comparison of outcome between egg collection, intrauterine insemination conversion, and follow-up cycles after abandonment.

    PubMed

    Nicopoullos, James D M; Abdalla, Hossam

    2011-01-01

    To determine optimal management with one or two mature follicles after stimulation. Retrospective analysis. Lister fertility clinic. A total of 1,350 IVF/intracytoplasmic sperm injection cycles (7.3% of total) during 1998-2009 were found to have one or two mature follicles. Group 1 (n = 807) comprised those who proceeded to vaginal egg collection (VEC) (59.8%; outcome per egg collection), group 2 (n=248) those who converted to IUI (18.4%; outcome per insemination) and group 3 (n=259) those who abandoned the current cycle (21.9%; outcome per abandoned cycle in first subsequent cycle). Live birth rate, clinical pregnancy rate, and biochemical pregnancy rate. Biochemical pregnancy rates of 13.1%, 4.9%, and 9.7%, clinical pregnancy rates of 8.1%, 3.6%, and 7.2%, and ongoing pregnancy rates of 6.8%, 2.0%, and 5.5% were achieved in groups 1, 2, and 3, respectively. All pregnancy outcomes were significantly higher after VEC (group 1) than for those converted to IUI (group 2), and all pregnancy outcomes were higher with borderline significance in group 3 vs. group 2. There was no significant difference in outcome between groups 1 and 3. Our data suggest that for such poor responders, proceeding to VEC may represent their best chance of successful outcome. Conversion to IUI offers the poorest outcome, and despite the potential for improvements in cycle protocol, abandoning and a further attempt does not improve outcome (using abandoned cycle as the denominator). Copyright © 2011 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved.

  6. Clinical outcomes research in gynecologic oncology.

    PubMed

    Melamed, Alexander; Rauh-Hain, J Alejandro; Schorge, John O

    2017-09-01

    Clinical outcomes research seeks to understand the real-world manifestations of clinical care. In particular, outcomes research seeks to reveal the effects of pharmaceutical, procedural, and structural aspects of healthcare on patient outcomes, including mortality, disease control, toxicity, cost, and quality of life. Although outcomes research can utilize interventional study designs, insightful use of observational data is a defining feature of this field. Many questions in gynecologic oncology are not amenable to investigation in randomized clinical trials due to cost, feasibility, or ethical concerns. When a randomized trial is not practical or has not yet been conducted, well-designed observational studies have the potential to provide the best available evidence about the effects of clinical care. Such studies may use surveys, medical records, disease registries, and a variety of administrative data sources. Even when a randomized trial has been conducted, observational studies can be used to estimate the real-world effect of an intervention, which may differ from the results obtained in the controlled setting of a clinical trial. This article reviews the goals, methodologies, data sources, and limitations of clinical outcomes research, with a focus on gynecologic oncology. Copyright © 2017. Published by Elsevier Inc.

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

    PubMed

    Jakobsen, Lars; Niemann, Troels; Thorsgaard, Niels; Thuesen, Leif; Lassen, Jens F; Jensen, Lisette O; Thayssen, Per; Ravkilde, Jan; Tilsted, Hans H; Mehnert, Frank; Johnsen, Søren P

    2012-10-01

    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. We studied 7385 patients treated with primary percutaneous coronary intervention. Participants were divided into high-SES and low-SES groups according to income, education, and employment status. The primary outcome was major adverse cardiac events (cardiac death, recurrent myocardial infarction, and target vessel revascularization) at maximum follow-up (mean, 3.7 years). Low-SES patients had more adverse baseline risk profiles than high-SES patients. The cumulative risk of major adverse cardiac events after maximum follow-up was higher among low-income patients and unemployed patients compared with their counterparts (income: hazard ratio, 1.68; 95% CI, 1.47-1.92; employment status: hazard ratio, 1.75; 95% CI, 1.46-2.10). After adjustment for patient characteristics, these differences were substantially attenuated (income: hazard ratio, 1.12; 95% CI, 0.93-1.33; employment status: hazard ratio, 1.27; 95% CI, 1.03-1.56). Further adjustment for admission findings, procedure-related data, and medical treatment during follow-up did not significantly affect the associations. With education as the SES indicator, no between-group differences were observed in the risk of the composite end point. Even in a tax-financed healthcare system, low-SES patients treated with primary percutaneous coronary intervention face a worse prognosis than high-SES patients. The poor outcome seems to be largely explained by differences in baseline patient characteristics. Employment status and income (but not education level) were associated with clinical outcomes.

  8. Impaired Patient-Reported Outcomes Predict Poor School Functioning and Daytime Sleepiness: The PROMIS Pediatric Asthma Study.

    PubMed

    Jones, Conor M; DeWalt, Darren A; Huang, I-Chan

    Poor asthma control in children is related to impaired patient-reported outcomes (PROs; eg, fatigue, depressive symptoms, anxiety), but less well studied is the effect of PROs on children's school performance and sleep outcomes. In this study we investigated whether the consistency status of PROs over time affected school functioning and daytime sleepiness in children with asthma. Of the 238 children with asthma enrolled in the Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric Asthma Study, 169 children who provided survey data for all 4 time points were used in the analysis. The child's PROs, school functioning, and daytime sleepiness were measured 4 times within a 15-month period. PRO domains included asthma impact, pain interference, fatigue, depressive symptoms, anxiety, and mobility. Each child was classified as having poor/fair versus good PROs per meaningful cut points. The consistency status of each domain was classified as consistently poor/fair if poor/fair status was present for at least 3 time points; otherwise, the status was classified as consistently good. Seemingly unrelated regression was performed to test if consistently poor/fair PROs predicted impaired school functioning and daytime sleepiness at the fourth time point. Consistently poor/fair in all PRO domains was significantly associated with impaired school functioning and excessive daytime sleepiness (Ps < .01) after controlling for the influence of the child's age, sex, and race/ethnicity. Children with asthma with consistently poor/fair PROs are at risk of poor school functioning and daytime sleepiness. Developing child-friendly PRO assessment systems to track PROs can inform potential problems in the school setting. Copyright © 2017 Academic Pediatric Association. Published by Elsevier Inc. All rights reserved.

  9. Inadequate vitamin D levels are associated with culture positive sepsis and poor outcomes in paediatric intensive care.

    PubMed

    Onwuneme, Chike; Carroll, Aoife; Doherty, Dermot; Bruell, Heike; Segurado, Ricardo; Kilbane, Mark; Murphy, Nuala; McKenna, Malachi J; Molloy, Eleanor J

    2015-10-01

    This study aimed to assess vitamin D status, and its determinants, in paediatric patients with suspected sepsis who were admitted to a paediatric intensive care unit (PICU). We also investigated the association between vitamin D status and clinical outcomes. Serum 25-hydroxy vitamin D (25OHD) and clinical determinants were prospectively assessed in children with suspected sepsis (<12 years old) admitted to the PICU. The relationship between 25OHD and clinical outcomes was evaluated. Vitamin D status was also assessed in control children of a similar age. We enrolled 120 children with suspected sepsis admitted to the PICU and 30 paediatric controls. 25OHD was <50 nmol/L in 59% of the children admitted to the PICU and 25OHD was lower than in the controls (47 ± 29 vs 66 ± 26 nmol/L, p < 0.001). After adjusting for potential confounders, 25OHD was strongly associated with culture positive sepsis (p < 0.001), the paediatric index of mortality (p = 0.026) and the duration of mechanical ventilation (p = 0.008). There was a negative correlation between 25OHD and C-reactive protein (CRP): each 0.1% decrease in 25OHD increased CRP (p = 0.04). Children admitted to the PICU with suspected sepsis had lower 25OHD than controls and inadequate 25OHD status was associated with confirmed sepsis and poor outcomes. ©2015 Foundation Acta Paediatrica. Published by John Wiley & Sons Ltd.

  10. High Dietary Glycemic Load is Associated with Poor Functional Outcome in Patients with Acute Cerebral Infarction.

    PubMed

    Song, Tae Jin; Chang, Yoonkyung; Chun, Min Young; Lee, Chan Young; Kim, A Ram; Kim, Yuri; Kim, Yong Jae

    2018-04-01

    Elevated postprandial blood glucose is a critical risk factor for stroke. The dietary glycemic load (GL) and glycemic index (GI) are frequently used as markers of the postprandial blood glucose response to estimate the overall glycemic effect of diets. We hypothesized that high dietary GL, GI, or total carbohydrate intake is associated with a poor functional outcome in patients with acute ischemic stroke. We prospectively included 263 first-ever ischemic stroke patients who completed a semiquantitative food-frequency questionnaire. The dietary GL, GI, and total carbohydrate intake were investigated by examining the average frequency of intake during the previous year based on reference amounts for various food items. Poor functional outcome was defined as a score on the modified Rankin Scale (mRS) of ≥3 at 3 months after stroke. The patients were aged 65.4±11.7 years (mean±standard deviation), and 58.2% of them were male. A multivariate analysis adjusted for age, sex, marital status, prestroke mRS score, diabetes mellitus, hyperlipidemia, body mass index, triglycerides, low-density lipoprotein, hemoglobin A1c, stroke classification, and National Institutes of Health Stroke Scale score, early neurological deterioration, and high-grade white-matter hyperintensities revealed that the dietary GL and total carbohydrate intake were associated with a poor functional outcome, with odds ratios for the top quartile relative to the bottom quartile of 28.93 (95% confidence interval=2.82-296.04) and 36.84 (95% confidence interval=2.99-453.42), respectively (p for trend=0.002 and 0.002, respectively). In contrast, high dietary GI was not associated with a poor functional outcome (p for trend=0.481). Increased dietary GL and carbohydrate intake were associated with a poor short-term functional outcome after an acute ischemic stroke. Copyright © 2018 Korean Neurological Association.

  11. The association between current unemployment and clinically determined poor oral health.

    PubMed

    Al-Sudani, Fouad Y H; Vehkalahti, Miira M; Suominen, Anna L

    2015-08-01

    The aim of this study was to assess whether current unemployment was associated with poor oral health and whether there was a difference in oral health according to the duration of the current unemployment. As part of the Health 2000 Survey in Finland (a nationwide comprehensive health examination survey), we used its data based on interviews, questionnaires, and clinical oral examinations of the 30- to 63-year-old respondents (n = 4773). Current employment status was measured in its dichotomous form, employed versus unemployed, and length of current unemployment was classified into four categories. We measured oral health in terms of numbers of missing teeth, of sound teeth, of filled teeth, of decayed teeth, and of teeth with deepened periodontal pockets (≥4 mm, ≥6 mm). Poisson regression models were fitted for all oral health outcomes except number of decayed teeth, for which negative binomial regression model was used. Oral health-related behaviors and sociodemographic and socioeconomic factors were added to the analyses. The unemployed subjects had higher numbers of missing teeth, of decayed teeth, and of teeth with periodontal pockets than the employed ones. The association remained consistent even after adjustments. Oral health-related behaviors seemed to mediate the association. We found no association between unemployment and number of sound teeth. Current long-term unemployment showed stronger association with poor oral health than short-term among women. The unemployed can be considered as a risk group for poor oral health. Oral healthcare should be reoriented toward those who are unemployed. © 2015 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

  12. Predictive Effects of Good Self-Control and Poor Regulation on Alcohol-Related Outcomes: Do Protective Behavioral Strategies Mediate?

    PubMed Central

    Pearson, Matthew R.; Kite, Benjamin A.; Henson, James M.

    2016-01-01

    In the present study, we examined whether use of protective behavioral strategies mediated the relationship between self-control constructs and alcohol-related outcomes. According to the two-mode model of self-control, good self-control (planfulness; measured with Future Time Perspective, Problem Solving, and Self-Reinforcement) and poor regulation (impulsivity; measured with Present Time Perspective, Poor Delay of Gratification, Distractibility) are theorized to be relatively independent constructs rather than opposite ends of a single continuum. The analytic sample consisted of 278 college student drinkers (68% women) who responded to a battery of surveys at a single time point. Using a structural equation model based on the two-mode model of self-control, we found that good self-control predicted increased use of three types of protective behavioral strategies (Manner of Drinking, Limiting/Stopping Drinking, and Serious Harm Reduction). Poor regulation was unrelated to use of protective behavioral strategies, but had direct effects on alcohol use and alcohol problems. Further, protective behavioral strategies mediated the relationship between good self-control and alcohol use. The clinical implications of these findings are discussed. PMID:22663345

  13. Pharmacokinetically and Clinician-Determined Adherence to an Antidepressant Regimen and Clinical Outcome in the TORDIA Trial

    ERIC Educational Resources Information Center

    Woldu, Hiwot; Porta, Giovanna; Goldstein, Tina; Sakolsky, Dara; Perel, James; Emslie, Graham; Mayes, Taryn; Clarke, Greg; Ryan, Neal D.; Birmaher, Boris; Wagner, Karen Dineen; Asarnow, Joan Rosenbaum; Keller, Martin B.; Brent, David

    2011-01-01

    Objective: Nonadherence to antidepressant treatment may contribute to poor outcome and to suicidal adverse events in adolescent depression. We examine the relationship between adherence and both clinical response and suicidal events in participants in the Treatment of Resistant Depression in Adolescents (TORDIA) study. Method: The relationship…

  14. Non-convulsive seizures and electroencephalography findings as predictors of clinical outcomes at a tertiary intensive care unit in Saudi Arabia.

    PubMed

    Al-Said, Youssef A; Baeesa, Saleh S; Shivji, Zaitoon; Kayyali, Husam; Alqadi, Khalid; Kadi, Ghada; Cupler, Edward J; Abuzinadah, Ahmad R

    2018-06-05

    Electroencephalography (EEG) in the intensive care unit (ICU) is often done to detect non-convulsive seizures (NCS). The outcome of ICU patients with NCS strongly depends on the underlying etiology. The implication of NCS and other EEG findings on clinical outcome independent from their etiology is not well understood and our aim to investigate it. We retrospectively identified all adult patients in the ICU who underwent EEG monitoring between January 2008 and December 2011. The main goals were to define the rate of NCS or non-convulsive status epilepticus (NCSE) occurrence in our center among patients who underwent EEG monitoring and to examine if NCS/NCSE are associated with poor outcome [defined as death or dependence] with and without adjustment for underlying etiology. The rate of poor outcome among different EEG categories were also investigated. During the study period, 177 patients underwent EEG monitoring in our ICU. The overall outcome was poor in 62.7% of those undergoing EEG. The rate of occurrence of NCS/NCSE was 8.5% and was associated with poor outcome in 86.7% with an odds ratio (OR) of 5.1 (95% confidence interval [CI] 1.09-23.8). This association was maintained after adjusting for underlying etiologies with OR 5.6 (95% CI 1.05-29.6). The rate of poor outcome was high in the presence of periodic discharges and sharp and slow waves of 75% and 61.5%, respectively. Our cohort of ICU patients undergoing EEGs had a poor outcome. Those who developed NCS/NCSE experienced an even worse outcome regardless of the underlying etiology. Copyright © 2018 Elsevier B.V. All rights reserved.

  15. Oedema is associated with clinical outcome following emergency abdominal surgery.

    PubMed

    Vaughan-Shaw, P G; Saunders, J; Smith, T; King, A T; Stroud, M A

    2013-09-01

    Oedema is observed frequently following surgery and may be associated with worse outcomes. To date, no study has investigated the role of oedema in the emergency surgical patient. This study assesses the incidence of oedema following emergency abdominal surgery and the value of early postoperative oedema measurement in predicting clinical outcome. A prospective cohort study of patients undergoing emergency abdominal surgery at a university unit over a two-month period was undertaken. Nutritional and clinical outcome data were collected and oedema was measured in the early postoperative period. Predictors of oedema and outcomes associated with postoperative oedema were identified through univariate and multivariate analysis. Overall, 55 patients (median age: 66 years) were included in the study. Postoperative morbidity included ileus (n=22) and sepsis (n=6) with 12 deaths at follow-up. Postoperative oedema was present in 19 patients and was associated with prolonged perioperative fasting (107 vs 30 hours, p=0.009) but not with body mass index (24 kg/m(2) vs 27 kg/m(2), p=0.169) or preadmission weight loss (5% vs 3%, p=0.923). On multivariate analysis, oedema was independently associated with gastrointestinal recovery (B=6.91, p=0.038), artificial nutritional support requirement (odds ratio: 6.91, p=0.037) and overall survival (χ(2) =13.1, df=1, p=0.001). Generalised oedema is common after emergency abdominal surgery and appears to independently predict gastrointestinal recovery, the need for artificial nutritional support and survival. Oedema is not associated with commonly applied markers of nutritional status such as body mass index or recent weight loss. Measurement of oedema offers utility in identifying those at risk of poor clinical outcome or those requiring artificial nutritional support following emergency abdominal surgery.

  16. Oedema is associated with clinical outcome following emergency abdominal surgery

    PubMed Central

    Vaughan-Shaw, PG; Saunders, J; Smith, T; King, AT

    2013-01-01

    Introduction Oedema is observed frequently following surgery and may be associated with worse outcomes. To date, no study has investigated the role of oedema in the emergency surgical patient. This study assesses the incidence of oedema following emergency abdominal surgery and the value of early postoperative oedema measurement in predicting clinical outcome. Methods A prospective cohort study of patients undergoing emergency abdominal surgery at a university unit over a two-month period was undertaken. Nutritional and clinical outcome data were collected and oedema was measured in the early postoperative period. Predictors of oedema and outcomes associated with postoperative oedema were identified through univariate and multivariate analysis. Results Overall, 55 patients (median age: 66 years) were included in the study. Postoperative morbidity included ileus (n=22) and sepsis (n=6) with 12 deaths at follow-up. Postoperative oedema was present in 19 patients and was associated with prolonged perioperative fasting (107 vs 30 hours, p=0.009) but not with body mass index (24kg/m2 vs 27kg/m2, p=0.169) or preadmission weight loss (5% vs 3%, p=0.923). On multivariate analysis, oedema was independently associated with gastrointestinal recovery (B=6.91, p=0.038), artificial nutritional support requirement (odds ratio: 6.91, p=0.037) and overall survival (χ2=13.1, df=1, p=0.001). Conclusions Generalised oedema is common after emergency abdominal surgery and appears to independently predict gastrointestinal recovery, the need for artificial nutritional support and survival. Oedema is not associated with commonly applied markers of nutritional status such as body mass index or recent weight loss. Measurement of oedema offers utility in identifying those at risk of poor clinical outcome or those requiring artificial nutritional support following emergency abdominal surgery. PMID:24025285

  17. Complement component 5 contributes to poor disease outcome in humans and mice with pneumococcal meningitis

    PubMed Central

    Woehrl, Bianca; Brouwer, Matthijs C.; Murr, Carmen; Heckenberg, Sebastiaan G.B.; Baas, Frank; Pfister, Hans W.; Zwinderman, Aeilko H.; Morgan, B. Paul; Barnum, Scott R.; van der Ende, Arie; Koedel, Uwe; van de Beek, Diederik

    2011-01-01

    Pneumococcal meningitis is the most common and severe form of bacterial meningitis. Fatality rates are substantial, and long-term sequelae develop in about half of survivors. Disease outcome has been related to the severity of the proinflammatory response in the subarachnoid space. The complement system, which mediates key inflammatory processes, has been implicated as a modulator of pneumococcal meningitis disease severity in animal studies. Additionally, SNPs in genes encoding complement pathway proteins have been linked to susceptibility to pneumococcal infection, although no associations with disease severity or outcome have been established. Here, we have performed a robust prospective nationwide genetic association study in patients with bacterial meningitis and found that a common nonsynonymous complement component 5 (C5) SNP (rs17611) is associated with unfavorable disease outcome. C5 fragment levels in cerebrospinal fluid (CSF) of patients with bacterial meningitis correlated with several clinical indicators of poor prognosis. Consistent with these human data, C5a receptor–deficient mice with pneumococcal meningitis had lower CSF wbc counts and decreased brain damage compared with WT mice. Adjuvant treatment with C5-specific monoclonal antibodies prevented death in all mice with pneumococcal meningitis. Thus, our results suggest C5-specific monoclonal antibodies could be a promising new antiinflammatory adjuvant therapy for pneumococcal meningitis. PMID:21926466

  18. Clinical outcome of patients with heart failure and preserved left ventricular function.

    PubMed

    Gotsman, Israel; Zwas, Donna; Planer, David; Azaz-Livshits, Tanya; Admon, Dan; Lotan, Chaim; Keren, Andre

    2008-11-01

    Patients with heart failure have a poor prognosis. However, it has been presumed that patients with heart failure and preserved left ventricular function (LVF) may have a more benign prognosis. We evaluated the clinical outcome of patients with heart failure and preserved LVF compared with patients with reduced function and the factors affecting prognosis. We prospectively evaluated 289 consecutive patients hospitalized with a definite clinical diagnosis of heart failure based on typical symptoms and signs. They were divided into 2 subsets based on echocardiographic LVF. Patients were followed clinically for a period of 1 year. Echocardiography showed that more than one third (36%) of the patients had preserved systolic LVF. These patients were more likely to be older and female and have less ischemic heart disease. The survival at 1 year in this group was poor and not significantly different from patients with reduced LVF (75% vs 71%, respectively). The adjusted survival by Cox regression analysis was not significantly different (P=.25). However, patients with preserved LVF had fewer rehospitalizations for heart failure (25% vs 35%, P<.05). Predictors of mortality in the whole group by multivariate analysis were age, diabetes, chronic renal failure, atrial fibrillation, residence in a nursing home, and serum sodium < or = 135 mEq/L. The prognosis of patients with clinical heart failure with or without preserved LVF is poor. Better treatment modalities are needed in both subsets.

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

    PubMed

    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

  20. Leveraging Epidemiology and Clinical Studies of Cancer Outcomes: Recommendations and Opportunities for Translational Research

    PubMed Central

    2013-01-01

    As the number of cancer survivors continues to grow, research investigating the factors that affect cancer outcomes, such as disease recurrence, risk of second malignant neoplasms, and the late effects of cancer treatments, becomes ever more important. Numerous epidemiologic studies have investigated factors that affect cancer risk, but far fewer have addressed the extent to which demographic, lifestyle, genomic, clinical, and psychosocial factors influence cancer outcomes. To identify research priorities as well as resources and infrastructure needed to advance the field of cancer outcomes and survivorship research, the National Cancer Institute sponsored a workshop titled “Utilizing Data from Cancer Survivor Cohorts: Understanding the Current State of Knowledge and Developing Future Research Priorities” on November 3, 2011, in Washington, DC. This commentary highlights recent findings presented at the workshop, opportunities to leverage existing data, and recommendations for future research, data, and infrastructure needed to address high priority clinical and research questions. Multidisciplinary teams that include epidemiologists, clinicians, biostatisticians, and bioinformaticists will be essential to facilitate future cancer outcome studies focused on improving clinical care of cancer patients, identifying those at high risk of poor outcomes, and implementing effective interventions to ultimately improve the quality and duration of survival. PMID:23197494

  1. Clinical outcomes and patients' perceptions of nurse-led healthy lifestyle clinics.

    PubMed

    Marshall, Bob; Floyd, Sue; Forrest, Rachel

    2011-03-01

    The Nurse-Led Healthy Lifestyle Clinics focussed on lifestyle issues for patients with known health inequalities. Much of the nursing was educative and preventative care. This evaluation assessed patient experiences and opinions, as well as clinical outcomes. Information came from clinical outcome data for 2850 individuals and 424 patient satisfaction surveys. Patients were aged 0-95 years (45% between 40 and 59 years); 60% Pakeha/European, 31.4% Maori, 4.2% Pacific and 4.4% other ethnicities. Only 19% of claimants (approximately 40% were Maori or Pacific) came from quintile 5 addresses, suggesting the target population was not reached effectively. Ninety-four percent of patients had a better understanding of their diagnosis, medication and treatment plan, and were more motivated to self-manage their health needs. This increase in patient empowerment is a significant outcome of the project. Clinical outcome data showed no significant differences between first and last clinic visits for average weight, blood pressure, smoking, glycosylated haemoglobin levels, waist circumference or cardiovascular risk. Significant improvements were shown in the Dartmouth Primary Care Cooperative Information results for social activity, change in health, and overall health (n=89). More effective techniques to access the target population have been implemented, as has an extended period for review of clinical outcomes. More focussed evaluation of clinical outcomes is necessary to provide quantitative data on the clinics. The large percentage of patients who felt more empowered to self-manage their health needs suggests the clinics were effective in this area.

  2. Treatment for Ulnar Neuritis Around the Elbow in Adolescent Baseball Players: Factors Associated With Poor Outcome.

    PubMed

    Maruyama, Masahiro; Satake, Hiroshi; Takahara, Masatoshi; Harada, Mikio; Uno, Tomohiro; Mura, Nariyuki; Takagi, Michiaki

    2017-03-01

    Ulnar neuritis around the elbow is one of the injuries seen in throwing athletes. Outcomes of nonsurgical treatment and factors associated with failure outcomes have not been reported. To investigate the outcomes of treatments for ulnar neuritis in adolescent baseball players. Case series; Level of evidence, 4. We assessed 40 male baseball players with a mean age of 15.0 years (range, 13-17 years) who presented with ulnar neuritis. There were 19 pitchers and 21 fielders whose throwing side was affected. All patients had elbow pain, and 13 patients had hand numbness on the ulnar side. The mean Kerlan-Jobe Orthopaedic Clinic (KJOC) overhead athlete shoulder and elbow score was 52.5 at the first follow-up visit (n = 36 patients). Thirteen patients were identified with ulnar nerve subluxation, and 23 patients had concomitant elbow ulnar collateral ligament (UCL) injury. All patients underwent nonsurgical treatment, which included rehabilitation exercises and prohibition of throwing. If the nonsurgical treatment failed, we recommended surgical treatment. We investigated the outcomes of the nonsurgical and surgical treatments. Return to sports was evaluated, combined with factors associated with return to sports in nonsurgical treatment by univariate and multivariate statistical analysis. The mean follow-up period was 23.6 months (range, 6-39 months). After nonsurgical treatment, 24 patients (60%) returned to the previous competition level after a mean of 2.4 months. Two patients returned to a recreational level. One patient gave up playing baseball at 2 months. The remaining 13 patients underwent surgery and returned to sports after a mean of 2.0 months postoperatively, and 12 had no limitation of sports activities. Multivariate logistical regression analysis demonstrated that hand numbness, ulnar nerve subluxation, and UCL injury were associated with failure of nonsurgical treatment ( P < .05). In addition, KJOC score of <45 at the first follow-up tended to be

  3. Low free triiodothyronine levels are related to symptomatic intracranial hemorrhage and poor functional outcomes after intravenous thrombolysis in acute ischemic stroke patients.

    PubMed

    Liu, Junfeng; Wang, Deren; Xiong, Yao; Yuan, Ruozhen; Tao, Wendan; Liu, Ming

    2016-05-01

    Low free triiodothyronine (fT3) levels have been associated with increased mortality and poor functional outcomes in patients with stroke. However, the research of relationship between fT3 levels and acute ischemic stroke (AIS) patients with intravenous thrombolysis (IVT) is scarce. We aimed to investigate the association of fT3 levels with symptomatic intracranial hemorrhage (sICH) and functional outcomes at discharge in AIS patients with IVT. Patients with AIS admitted to West China hospital, Sichuan University, who had underwent IVT treatment, were consecutively and retrospectively included. Demographic and clinical information were collected and analyzed according to the levels of fT3. We used logistic regression analysis to estimate the multivariable adjusted association of fT3 levels and post-IVT sICH, and functional outcomes at discharge. Among the 46 patients (26 males; mean age, 63.6 years) in the final analysis, 17 patients (37.0%) had fT3 levels lower than the reference range. After adjustment for age, gender, and statistically important variables (NIHSS on admission, urea levels and creatinine levels), low fT3 levels were significantly associated with post-IVT sICH (p = 0.01, OR = 0.27, 95% CI 0.10-0.77) and poor functional outcomes at discharge (p = 0.04 OR = 2.58, 95% CI 1.05-6.35). We found that lower free T3 levels are independently related to post-IVT sICH and poor functional outcomes at discharge in AIS patients with IVT, which should be verified and extended in large cohorts in the future.

  4. [The Spectrum of Neuromyotonia: Clinics, Therapy and Outcome].

    PubMed

    Wenninger, S; Schoser, B

    2015-08-01

    Neuromyotonia (NM), Isaacs-Zschoke-Mertens syndrome or continuous muscle fiber activity (CMFA), is a rare condition associated with VGKC-antibodies. Clinically, fasciculations, myokymias, muscle stiffness and a myotonic appearance of movements after contraction are typical findings. In addition, CNS-symptoms vary from moderate fatigue, poor concentration and autonomic symptoms to severe encephalopathy in Morvan's syndrome. In electromyography, spontaneous irregular discharges can be found frequently with typical di-, tri- or multiplet single motor unit discharges. In up to 60 %, serum antibodies against VGKC-complexes can be detected. Patients with neuromyotonia were evaluated for clinical symptoms, response to treatment and outcome over a five-year period of follow-up. For evaluation, we used video recording of clinical symptoms, electroneurography, electromyography and myosonography as well as immunological tests (VGKC-complex antibody including CASPR2 and IGL1). Furthermore, cerebral fluid and screening for neoplasias were done. Patients with evidence for neuropathy, myopathy or motor neuron disease, even if diagnosed in the follow-up, were excluded. In 3 of 5 patients, neuromyotonia was diagnosed by electromyography and positive VGKC antibodies. In two patients, diagnosis was based on typical clinical symptoms and electromyographical changes. Anticonvulsants (carbamazepine) for symptomatic treatment were moderately effective in four patients; treatment with i. v. immunoglobulins was highly successful in one patient with high positive VGKC-complex antibody titers. In one patient with low-titer VGKC antibodies, neither anticonvulsants nor i. v. immunoglobulins nor prednisone was a successful treatment. Neuromyotonia is a rare, treatable condition. However, due to the high variability of symptoms, response to therapy and outcome, neuromyotonia treatment needs to be highly individualized. © Georg Thieme Verlag KG Stuttgart · New York.

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

    PubMed

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

    2015-09-01

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

  6. The association between teenage motherhood and poor offspring outcomes: A national cohort study across 30 years

    PubMed Central

    Coyne, Claire A; Långström, Niklas; Rickert, Martin E; Lichtenstein, Paul; D’Onofrio, Brian M

    2013-01-01

    Teenage motherhood is associated with poor offspring outcomes but these associations may be influenced by offspring birth year because of substantial social changes in recent decades. Existing research also has not examined whether these associations are due to the specific effect of mother’s age at childbirth or factors shared by siblings in a family. We used a population-based cohort study in Sweden comprising all children born from 1960–1989 (N=3,162,239), and a subsample of siblings differentially exposed to maternal teenage childbearing (N=485,259) to address these limitations. We examined the effect of teenage childbearing on offspring violent and nonviolent criminal convictions, poor academic performance, and substance-related problems. Population-wide, teenage childbearing was associated with offspring criminal convictions, poor academic performance, and substance-related problems. The magnitude of these associations increased over time. Comparisons of differentially exposed siblings indicated no within-family association between teenage childbearing and offspring violent and nonviolent criminal convictions or poor academic performance, although offspring born to teenage mothers were more likely to experience substance-related problems than their later-born siblings. Being born to a teenage mother in Sweden has become increasingly associated with negative outcomes across time, but the nature of this association may differ by outcome. Teenage childbearing may be associated with offspring violent and nonviolent criminal convictions and poor academic performance because of shared familial risk factors but may be causally associated with offspring substance-related problems. The findings suggest that interventions to improve offspring outcomes should delay teenage childbearing and target risk factors influencing all offspring of teenage mothers. PMID:23632141

  7. Adverse events associated with poor neurological outcome during targeted temperature management and advanced critical care after out-of-hospital cardiac arrest.

    PubMed

    Kim, Young-Min; Youn, Chun Song; Kim, Soo Hyun; Lee, Byung Kook; Cho, In Soo; Cho, Gyu Chong; Jeung, Kyung Woon; Oh, Sang Hoon; Choi, Seung Pill; Shin, Jong Hwan; Cha, Kyoung-Chul; Oh, Joo Suk; Yim, Hyeon Woo; Park, Kyu Nam

    2015-07-22

    The aim of this study was to investigate the association of adverse events (AEs) during targeted temperature management (TTM) and other AEs and concomitant treatments during the advanced critical care period with poor neurological outcome at hospital discharge in adult out-of-hospital cardiac arrest (OHCA) patients. This was a retrospective study using Korean Hypothermia Network registry data of adult OHCA patients treated with TTM in 24 teaching hospitals throughout South Korea from 2007 to 2012. Demographic characteristics, resuscitation and post-resuscitation variables, AEs, and concomitant treatments during TTM and the advanced critical care were collected. The primary outcome was poor neurological outcome, defined as a cerebral performance category (CPC) score of 3-5 at hospital discharge. The AEs and concomitant treatments were individually entered into the best multivariable predictive model of poor neurological outcome to evaluate the associations between each variable and outcome. A total of 930 patients, including 704 for whom a complete dataset of AEs and covariates was available for multivariable modeling, were included in the analysis; 476 of these patients exhibited poor neurological outcome [CPC 3 = 50 (7.1%), CPC 4 = 214 (30.4%), and CPC 5 = 212 (30.1%)]. Common AEs included hyperglycemia (45.6%), hypokalemia (31.3%), arrhythmia (21.3%) and hypotension (29%) during cooling, and hypotension (21.6%) during rewarming. Bleeding (5%) during TTM was a rare AE. Common AEs during the advanced critical care included pneumonia (39.6%), myoclonus (21.9%), seizures (21.7%) and hypoglycemia within 72 hours (23%). After adjusting for independent predictors of outcome, cooling- and rewarming-related AEs were not significantly associated with poor neurological outcome. However, sepsis, myoclonus, seizure, hypoglycemia within 72 hours and anticonvulsant use during the advanced critical care were associated with poor neurological outcome [adjusted odds

  8. Children of Parents with Intellectual Disability: Facing Poor Outcomes or Faring Okay?

    ERIC Educational Resources Information Center

    Collings, Susan; Llewellyn, Gwynnyth

    2012-01-01

    Background: Children of parents with intellectual disability are assumed to be at risk of poor outcomes but a comprehensive review of the literature has not previously been undertaken. Method: A database and reference search from March 2010 to March 2011 resulted in 26 studies for review. Results: Two groups of studies were identified. The first…

  9. Access to orphan drugs despite poor quality of clinical evidence

    PubMed Central

    Dupont, Alain G; Van Wilder, Philippe B

    2011-01-01

    AIM We analysed the Belgian reimbursement decisions of orphan drugs as compared with those of innovative drugs for more common but equally severe diseases, with special emphasis on the quality of clinical evidence. METHODS Using the National Health Insurance Agency administrative database, we evaluated all submitted orphan drug files between 2002 and 2007. A quality analysis of the clinical evidence in the orphan reimbursement files was performed. The evaluation reports of the French ‘Haute Autorité de Santé’, including the five-point scale parameter ‘Service Médical Rendu (SMR), were examined to compare disease severity. Chi-squared tests (at P < 0.05 significance level) were used to compare the outcome of the reimbursement decisions between orphan and non-orphan innovative medicines. RESULTS Twenty-five files of orphan drugs and 117 files of non-orphan drugs were evaluated. Twenty-two of 25 (88%) submissions of orphan drugs were granted reimbursement as opposed to 74 of the 117 (63%) non-orphan innovative medicines (P = 0.02). Only 52% of the 25 orphan drug files included a randomized controlled trial as opposed to 84% in a random control sample of 25 non-orphan innovative submissions (P < 0.01). The duration of drug exposure was in most cases far too short in relation to the natural history of the disease. CONCLUSIONS Orphan drug designation predicts reimbursement despite poor quality of clinical evidence. The evidence gap at market authorization should be reduced by post-marketing programmes, in which the centralized regulatory and the local reimbursement authorities collaborate in an efficient way across the European Union member states. PMID:21395641

  10. Social Cognition in Psychosis: Multidimensional Structure, Clinical Correlates, and Relationship With Functional Outcome

    PubMed Central

    Mancuso, Francesco; Horan, William P.; Kern, Robert S.; Green, Michael F.

    2010-01-01

    Social cognitive impairments are common, detectable across a wide range of tasks, and appear to play a key role in explaining poor outcome in schizophrenia and related psychotic disorders. However, little is known about the underlying factor structure of social cognition in people with psychotic disorders due to a lack of exploratory factor analyses using a relatively comprehensive social cognitive assessment battery. In a sample of 85 outpatients with psychosis, we examined the factor structure and clinical/functional correlates of eight indexes derived from five social cognition tasks that span the domains of emotional processing, social perception, attributional style, and Theory of Mind. Exploratory factor analysis revealed three factors with relatively low inter-correlations that explained a total of 54% of the variance: (1) Hostile attributional style, (2) Lower-level social cue detection, and (3) Higher-level inferential and regulatory processes. None of the factors showed significant correlations with negative symptoms. Factor 1 significantly correlated with clinical symptoms (positive, depression-anxiety, agitation) but not functional outcome, whereas Factors 2 and 3 significantly correlated with functional outcome (functional capacity and real-world social and work functioning) but not clinical symptoms. Furthermore, Factor 2 accounted for unique incremental variance in functional capacity, above and beyond non-social neurocognition (measured with MATRICS Consensus Cognitive Battery) and negative symptoms. Results suggest that multiple separable dimensions of social cognition can be identified in psychosis, and these factors show distinct patterns of correlation with clinical features and functional outcome. PMID:21112743

  11. The relationships among acculturation, biobehavioral risk, stress, corticotropin-releasing hormone, and poor birth outcomes in Hispanic women.

    PubMed

    Ruiz, R Jeanne; Dolbier, Christyn L; Fleschler, Robin

    2006-01-01

    To determine the predictive ability of acculturation as an antecedent of stress, biobehavioral risk, corticotropin-releasing hormone levels, and poor birth outcomes in pregnant Hispanic women. A prospective, observational design with data collected at 22-25 weeks of gestation and at birth through medical record review. Public prenatal health clinics in south Texas serving low-income women. Self-identified Hispanic women who had singleton pregnancies, no major medical risk complications, and consented to answer questionnaires as well as a venipuncture and review of their prenatal and birth medical records. Gestational age, Apgar scores, length, weight, percentile size, and head circumference of the infant at birth. Significant differences were seen in infant birth weight, head circumference, and percentile size by acculturation. English acculturation predicted stress, corticotropin-releasing hormone, biobehavioral risk, and decreased gestational age at birth. Investigation must continue to understand the circumstances that give rise to the decline in birth outcomes observed in Hispanics with acculturation to the dominant English culture in the United States.

  12. Clinical Value of Dorsal Medulla Oblongata Involvement Detected with Conventional MRI for Prediction of Outcome in Children with Enterovirus 71-related Brainstem Encephalitis.

    PubMed

    Liu, Kun; Zhou, Yongjin; Cui, Shihan; Song, Jiawen; Ye, Peipei; Xiang, Wei; Huang, Xiaoyan; Chen, Yiping; Yan, Zhihan; Ye, Xinjian

    2018-04-05

    Brainstem encephalitis is the most common neurologic complication after enterovirus 71 infection. The involvement of brainstem, especially the dorsal medulla oblongata, can cause severe sequelae or death in children with enterovirus 71 infection. We aimed to determine the prevalence of dorsal medulla oblongata involvement in children with enterovirus 71-related brainstem encephalitis (EBE) by using conventional MRI and to evaluate the value of dorsal medulla oblongata involvement in outcome prediction. 46 children with EBE were enrolled in the study. All subjects underwent a 1.5 Tesla MR examination of the brain. The disease distribution and clinical data were collected. Dichotomized outcomes (good versus poor) at longer than 6 months were available for 28 patients. Logistic regression was used to determine whether the MRI-confirmed dorsal medulla oblongata involvement resulted in improved clinical outcome prediction when compared with other location involvement. Of the 46 patients, 35 had MRI evidence of dorsal medulla oblongata involvement, 32 had pons involvement, 10 had midbrain involvement, and 7 had dentate nuclei involvement. Patients with dorsal medulla oblongata involvement or multiple area involvement were significantly more often in the poor outcome group than in the good outcome group. Logistic regression analysis showed that dorsal medulla oblongata involvement was the most significant single variable in outcome prediction (predictive accuracy, 90.5%), followed by multiple area involvement, age, and initial glasgow coma scale score. Dorsal medulla oblongata involvement on conventional MRI correlated significantly with poor outcomes in EBE children, improved outcome prediction when compared with other clinical and disease location variables, and was most predictive when combined with multiple area involvement, glasgow coma scale score and age.

  13. Midterm clinical outcomes following arthroscopic transosseous rotator cuff repair

    PubMed Central

    Flanagin, Brody A.; Garofalo, Raffaele; Lo, Eddie Y.; Feher, LeeAnne; Castagna, Alessandro; Qin, Huanying; Krishnan, Sumant G.

    2016-01-01

    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 leads to

  14. Presentation and outcome of clinical poor performance in one health district over a 5-year period: 2002-2007.

    PubMed

    Cox, Stephen J; Holden, John D

    2009-05-01

    The detection, assessment, and management of primary care poor performance raise difficult issues for all those involved. Guidance has largely focused on managing the most serious cases where patient safety is severely compromised. The management of primary care poor performance has become an increasingly important part of primary care trust (PCT) work, but its modes of presentation and prevalence are not well known. To report the prevalence, presentation modes, and management of primary care poor performance cases presenting to one PCT over a 5-year period. A retrospective review of primary care poor performance cases in one district. St Helens PCT administered 35 practices with 130 GPs on the performers list, caring for 190 110 patients in North West England, UK. Cases presenting during 2002-2007 were initially reviewed by the chair of the PCT clinical executive committee. Anonymised data were then jointly reviewed by the assessor and another experienced GP advisor. There were 102 individual presentations (20 per year or one every 2-3 weeks) where clinician performance raised significant cause for concern occurred over the 5-year period. These concerns related to 37 individual clinicians, a range of 1-14 per clinician (mean 2.7). Whistleblowing by professional colleagues on 43 occasions was the most common presentation, of which 26 were from GPs about GPs. Patient complaints (18) were the second most common presentation. Twenty-seven clinicians were GPs, of whom the General Medical Council (GMC) were notified or involved in 13 cases. Clinicians were supported locally, and remedying was exclusively locally managed in 14 cases, and shared with an external organisation (such as the GMC or deanery) in another 12. Professional whistleblowing and patient complaints were the most common sources of presentation. Effective PCT teams are needed to manage clinicians whose performance gives cause for concern. Sufficient resources and both formal and informal ways of

  15. Outcomes from a nurse-led clinic for adolescents with epilepsy.

    PubMed

    Stephen, Linda J; Maxwell, Jan; Brodie, Martin J

    2003-12-01

    Epilepsy is the commonest serious neurological condition to affect adolescents. We established a nurse-led clinic for young people with suspected or diagnosed epilepsy. Outcomes in all patients referred during the first 4 years after its inception are reported. A total of 301 adolescents were seen at the clinic during 1996-1999. Epilepsy was excluded in 135 (45%), including 5 receiving antiepileptic drug (AED) therapy. A single seizure occurred in 22 (7%) others. Seventy-six patients (25%) had treated epilepsy and 68 (23%) were newly diagnosed. More than 1 year's seizure freedom was achieved by 53% of patients, 76% with one AED, 16% with two and 3% with three. Four (5%) patients remained seizure free off medication. Sixteen (11%) were lost to follow-up. Outcome was better (P<0.05) for newly diagnosed (59% seizure free) than for treated (47% seizure free) epilepsy and for idiopathic generalised (60% seizure free) than for partial (46% seizure free) seizures (P<0.02). Magnetic resonance imaging of brain was obtained in 63 (85%) patients with localisation-related epilepsy. Findings were abnormal in 43%, including nine with cortical dysplasia, eight with mesial temporal sclerosis and two with gliomas. Epilepsy can be difficult to diagnose in adolescents. Outcomes were surprisingly poor suggesting the need for improved services for this patient population.

  16. Adolescent and parent motivation for change affects psychotherapy outcomes among youth with poorly controlled diabetes.

    PubMed

    Ellis, Deborah A; Berio, Heidi; Carcone, April Idalski; Naar-King, Sylvie

    2012-01-01

    Investigate effect of baseline motivation for change on treatment fidelity, therapeutic alliance, treatment dose, and treatment outcome in a randomized controlled trial of family therapy for youth with poorly controlled diabetes. Seventy-four adolescents and caregivers completed measures of motivation for change. Measures of fidelity, alliance, dose, and youth health status were collected. Structural equation modeling was used to test the direct and indirect effects of motivation on treatment outcomes. Parent motivation was significantly related to alliance and fidelity. Only alliance was significantly related to posttreatment metabolic control. In adolescent models, only motivation was significantly related to alliance. In both models, motivation had a significant indirect effect on metabolic control through alliance. Findings demonstrate the importance of parent and youth initial motivational status and treatment alliance to treatment outcome among youth with poorly controlled diabetes. Additional research on treatment techniques that promote motivation for change is needed.

  17. Clinical outcomes and quality of life in recipients of livers donated after cardiac death.

    PubMed

    Parikh, Neehar D; Skaro, Anton I; Ladner, Daniela P; Lyuksemburg, Vadim; Cahan, Joshua G; Daud, Amna; Butt, Zeeshan

    2015-01-01

    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.

  18. Do clinical outcomes correlate with bone density after open reduction and internal fixation of tibial plateau fractures.

    PubMed

    Gausden, Elizabeth; Garner, Matthew R; Fabricant, Peter D; Warner, Stephen J; Shaffer, Andre D; Lorich, Dean G

    2017-06-01

    The operative management of tibial plateau fractures in elderly patients has historically led to inconsistent results, and these clinical outcomes were thought to be associated with poor bone quality often in elderly patients. The goal of this study was to investigate the relationship between bone density and subjective clinical outcome scores after open reduction and internal fixation of tibial plateau fractures. This is a retrospective cohort study from a single-surgeon conducted at an Academic, Level 1 Trauma Center. A preoperative computed tomography (CT) scan was obtained for all patients. Bone density of the distal femur was quantified with Hounsfield units (HU) as measured on axial CT scans. Inter-rater reliability of HU measurements was assessed using interclass correlation coefficients. Regression models controlling for age were used to identify relationships between bone density (HU) and the following variables: articular subsidence and 1-year subjective clinical outcomes scores [Knee Outcome Survey Activities of Daily Living Scale (KOS-ADLS), and Short-Form-36 (SF-36) physical and mental component scores (PCS, MCS)]. Sixty-one patients with a mean age of 59.3 years (range 27-85 years) and a minimum of 12 months of clinical follow-up were included in the study. The majority of the fractures (32 of 61) were classified as Schatzker II tibial plateau fractures, and there were 13 Schatzker V fractures, 11 Schatzker VI fractures, 2 Schatzker IV fractures and 1 Schatzker 1 fracture. HU measurements demonstrated an almost perfect inter-observer reliability (ICC = 0.97). Age was negatively correlated with HU measurements (r = -0.51, p < 0.001), and using a geriatric cut-off of 65 years of age, the geriatric group had a lower mean HU compared to the non-geriatric group (78.2 versus 114.8, p = 0.018). There was no significant relationship between bone quality, as assessed by distal femoral HU, and any subjective clinical outcome score. Inferior

  19. Lower uric acid is associated with poor short-term outcome and a higher frequency of posterior arterial involvement in ischemic stroke.

    PubMed

    Liu, Hanxiang; Reynolds, Gavin P; Wang, Wenmin; Wei, Xianwen

    2018-06-01

    Uric acid has neuroprotective properties in experimental and clinical studies of neurodegenerative disease. It is, however, associated with increased risk of stroke, yet, despite some inconsistent findings, increasing evidence suggests it may also be related to improved stroke outcomes. We have determined whether there is an effect of plasma uric acid on the short-term outcome of stroke patients in a general hospital setting using the modified Rankin Scale (mRS). We also investigated the relationship of uric acid with other clinical correlates. Plasma uric acid was determined in 108 acute ischemic stroke patients and their mRS scores measured. Patients with a poor outcome (mRS > 2) had significantly lower uric acid than those with a better outcome; this remained after correcting for the effect of sex on uric acid concentrations. There was no significant association with other epidemiological factors or with cognitive function determined by Mini-Mental State Examination. An association between uric acid and the cerebral circulation was also found in which lower uric acid occurs with posterior artery involvement. These findings demonstrate in a naturalistic cohort of patients the association of uric acid with short-term disability following ischemic stroke. They also raise the question of whether uric acid may influence the regional brain involvement in stroke.

  20. The impact of anismus on the clinical outcome of rectocele repair.

    PubMed

    van Dam, J H; Schouten, W R; Ginai, A Z; Huisman, W M; Hop, W C

    1996-01-01

    There are doubts as to whether rectocele repair (RR) is beneficial for patients with concomitant anismus. The aim of this prospective study was to evaluate the effect of anismus on the clinical outcome of RR. In 71 out of 75 patients who underwent RR evacuation proctography (EP) was performed. Electromyography (EMG) of the pelvic floor and balloon expulsion test (BET) were carried out in 61 and 35 patients respectively. On EP, measuring the central anorectal angle (CARA) and the posterior anorectal angle (PARA), signs of anismus were found in 34 and 28 percent of the patients respectively. EMG and BET revealed anismus in 39 and 71 percent of the patients respectively. These results showed poor agreement. RR was successful in 53 (71%) out of 75 patients (follow up 14-74 months). No differences were found in clinical outcome in patients with and without signs of anismus. In conclusion, RR is beneficial for patients with obstructed defecation, and signs of anismus do not appear to be a contraindication for RR.

  1. The Clinical Outcomes of Lower Gastrointestinal Bleeding Are Not Better than Those of Upper Gastrointestinal Bleeding.

    PubMed

    Kwak, Min Seob; Cha, Jae Myung; Han, Yong Jae; Yoon, Jin Young; Jeon, Jung Won; Shin, Hyun Phil; Joo, Kwang Ro; Lee, Joung Il

    2016-10-01

    The incidence of lower gastrointestinal bleeding (LGIB) is increasing; however, predictors of outcomes for patients with LGIB are not as well defined as those for patients with upper gastrointestinal bleeding (UGIB). The aim of this study was to identify the clinical outcomes and the predictors of poor outcomes for patients with LGIB, compared to outcomes for patients with UGIB. We identified patients with LGIB or UGIB who underwent endoscopic procedures between July 2006 and February 2013. Propensity score matching was used to improve comparability between LGIB and UGIB groups. The clinical outcomes and predictors of 30-day rebleeding and mortality rate were analyzed between the two groups. In total, 601 patients with UGIB (n = 500) or LGIB (n = 101) were included in the study, and 202 patients with UGIB and 101 patients with LGIB were analyzed after 2:1 propensity score matching. The 30-day rebleeding and mortality rates were 9.9% and 4.5% for the UGIB group, and 16.8% and 5.0% for LGIB group, respectively. After logistic regression analysis, the Rockall score (P = 0.013) and C-reactive protein (CRP; P = 0.047) levels were significant predictors of 30-day mortality in patients with LGIB; however, we could not identify any predictors of rebleeding in patients with LGIB. The clinical outcomes for patients with LGIB are not better than clinical outcomes for patients with UGIB. The clinical Rockall score and serum CRP levels may be used to predict 30-day mortality in patients with LGIB.

  2. Glomerular Immune Deposits Are Predictive of Poor Long-Term Outcome in Patients with Adult Biopsy-Proven Minimal Change Disease: A Cohort Study in Korea.

    PubMed

    Lee, Sung Woo; Yu, Mi-Yeon; Baek, Seon Ha; Ahn, Shin-Young; Kim, Sejoong; Na, Ki Young; Chae, Dong-Wan; Chin, Ho Jun

    2016-01-01

    There has been little published information on risk factors for poor long-term outcome in adult biopsy-proven minimal change disease (MCD). Data from sixty-three adult, biopsy-proven primary MCD patients treated at a tertiary university hospital between 2003 and 2013 were analyzed. Baseline clinical and pathologic factors were assessed for the associations with composite outcome of creatinine doubling, end stage renal disease, or all-cause mortality. During a median (interquartile) 5.0 (2.8-5.0) years, the composite outcome occurred in 11.1% (7/63) of patients. The rate of glomerular immune deposits was 23.8% (15/63). Patients with glomerular immune deposits showed a significantly lower urine protein creatinine ratio than those without deposits (P = 0.033). The rate of non-responders was significantly higher in patients with glomerular immune deposits than in those without deposits (P = 0.033). In patients with deposits, 26.7% (4/15) developed the composite outcome, while only 6.3% (3/48) developed the composite outcome among those without deposits (P = 0.049). In multivariate Cox proportional hazards regression analysis, the presence of glomerular immune deposits was the only factor associated with development of the composite outcome (hazard ratio: 2.310, 95% confidence interval: 1.031-98.579, P = 0.047). Glomerular immune deposits were associated with increased risk of a composite outcome in adult MCD patients. The higher rate of non-responders in patients with deposits might be related to the poor outcome. Future study is needed.

  3. Clinical Features and Outcomes of Gastric Ischemia.

    PubMed

    Sharma, Ayush; Mukewar, Saurabh; Chari, Suresh T; Wong Kee Song, Louis M

    2017-12-01

    Gastric ischemia is a rare condition associated with poor prognosis. Our study aim was to highlight the clinical features and outcomes of patients with gastric ischemia. A retrospective review of patients diagnosed with isolated gastric ischemia at our institution from January 1, 2000, to May 5, 2016, was performed. Demographic, clinical, endoscopic, radiologic, and outcome variables were abstracted for analysis. Seventeen patients (65% men) with mean age of 69.3 ± 11.3 years and body mass index of 28.8 ± 11.1 were identified. The etiologies for gastric ischemia included local vascular causes (n = 8), systemic hypoperfusion (n = 4), and mechanical obstruction (n = 5). The most common presenting symptoms were abdominal pain (65%), gastrointestinal bleeding (47%), and altered mental status (23%). The typical endoscopic appearance was mucosal congestion and erythema with or without ulceration. Gastric pneumatosis and portal venous air were more commonly seen on CT imaging. Radiologic and/or surgical intervention was needed in 9 patients, while the remaining 8 patients were managed conservatively with acid suppression, antibiotics, and nasogastric tube decompression. The median duration of hospital stay was 15 days (range 1-36 days). There were no cases of rebleeding and the mortality rate as a direct result of gastric ischemia was 24% within 6 months of diagnosis. Although uncommon, gastric ischemia is associated with significant mortality. Endoscopy and CT imaging play an important role in its diagnosis. The management of gastric ischemia is dictated by its severity and associated comorbidities.

  4. Association of stroke clinical outcomes with coexistence of hyperglycemia and biomarkers of inflammation.

    PubMed

    Zhou, Jingwen; Wu, Jiahui; Zhang, Jintao; Xu, Tan; Zhang, Huan; Zhang, Yonghong; Zhang, Shaoyan

    2015-06-01

    To investigate the association of short-term clinical outcomes with coexistence of hyperglycemia and elevated biomarkers of inflammation among acute ischemic stroke (AIS) patients. We performed a retrospective study of 2675 patients diagnosed with AIS from January 2006 to December 2008. The study outcomes were defined as neurologic deficiency (National Institutes of Health Stroke Scale score ≥5) at discharge or death during hospitalization. Compared with normoglycemia and without any elevated biomarkers, patients with hyperglycemia, elevated white blood cell (WBC) count, elevated neutrophils ratio (NEUR), and elevated erythrocyte sedimentation rate (ESR) had higher rates of study outcomes (all P < .05). Furthermore, patients with coexistence of hyperglycemia with any of elevated WBC count, NEUR, or ESR were more likely to have study outcomes (all P < .05). Compared with subjects with normoglycaemia and without any elevated biomarker, multivariate adjusted odds ratios (95% confidence interval) of study outcomes associated with hyperglycemia, elevated WBC count, elevated NEUR, elevated ESR, coexistences of hyperglycemia with elevated WBC count, elevated NEUR, and elevated ESR were 1.492 (1.139-1.955), 1.404 (1.048-1.881), 1.897 (1.411-2.551), 2.184 (1.339-3.564), 1.963 (1.337-2.883), 2.544(1.715- 3.775), and 2.687 (1.347-5.363), respectively. This study indicated that hyperglycemia and elevated biomarkers of inflammation were associated with short-term clinical outcomes, and individuals with coexistence of hyperglycemia and elevated biomarkers of inflammation had higher risk of poor clinical outcomes among AIS patients. Copyright © 2015 National Stroke Association. Published by Elsevier Inc. All rights reserved.

  5. Familial acute necrotizing encephalopathy without RANBP2 mutation: Poor outcome.

    PubMed

    Nishimura, Naoko; Higuchi, Yoshihisa; Kimura, Nobusuke; Nozaki, Fumihito; Kumada, Tomohiro; Hoshino, Ai; Saitoh, Makiko; Mizuguchi, Masashi

    2016-11-01

    Most childhood cases of acute necrotizing encephalopathy (ANE) involve neither family history nor recurrence. ANE occasionally occurs, however, as a familial disorder or recurs in Caucasian patients. A mutation of RAN-binding protein 2 (RANBP2) has been discovered in more than one half of familial or recurrent ANE patients. In contrast, there has been no report of this mutation in East Asia. Here, we report the first sibling cases of typical ANE in Japan, with poor outcome. DNA analysis of genes associated with ANE or other encephalopathies, including RANBP2 and carnitine palmitoyl transferase II (CPT2), indicated neither mutations nor disease-related polymorphisms. On literature review, recurrent or familial ANE without the RANBP2 mutation has a more severe outcome and greater predilection for male sex than that with the RANBP2 mutation. This suggests that there are unknown gene mutations linked to ANE. © 2016 Japan Pediatric Society.

  6. Pediatric multiple sclerosis: Clinical features and outcome.

    PubMed

    Waldman, Amy; Ness, Jayne; Pohl, Daniela; Simone, Isabella Laura; Anlar, Banu; Amato, Maria Pia; Ghezzi, Angelo

    2016-08-30

    Multiple sclerosis (MS) in children manifests with a relapsing-remitting MS (RRMS) disease course. Acute relapses consist of new neurologic deficits persisting greater than 24 hours, in the absence of intercurrent illness, and occur with a higher frequency early in the disease as compared to adult-onset RRMS. Most pediatric patients with MS recover well from these early relapses, and cumulative physical disability is rare in the first 10 years of disease. Brainstem attacks, poor recovery from a single attack, and a higher frequency of attacks portend a greater likelihood of future disability. Although prospective pediatric-onset MS cohorts have been established in recent years, there remains very limited prospective data detailing the longer-term clinical outcome of pediatric-onset MS into adulthood. Whether the advent of MS therapies, and the largely off-label access to such therapies in pediatric MS, has improved prognosis is unknown. MS onset during the key formative academic years, concurrent with active cognitive maturation, is an important determinant of long-term outcome, and is discussed in detail in another article in this supplement. Finally, increasing recognition of pediatric MS worldwide, recent launch of phase III trials for new agents in the pediatric MS population, and the clear imperative to more fully appreciate health-related quality of life in pediatric MS through adulthood highlight the need for standardized, validated, and robust outcome measures. © 2016 American Academy of Neurology.

  7. Delayed gadolinium-enhanced MRI of cartilage (dGEMRIC) and T2 mapping of talar osteochondral lesions: Indicators of clinical outcomes.

    PubMed

    Rehnitz, Christoph; Kuni, Benita; Wuennemann, Felix; Chloridis, Dimitrios; Kirwadi, Anand; Burkholder, Iris; Kauczor, Hans-Ulrich; Weber, Marc-André

    2017-12-01

    To evaluate the utility of delayed gadolinium-enhanced magnetic resonance imaging of cartilage (dGEMRIC) and T 2 mapping in evaluation of type II osteochondral lesions (OCLs) of the talus and define cutoff values for identifying patients with good/poor clinical outcomes. 28 patients (mean age, 42.3 years) underwent T 2 mapping and dGEMRIC at least 1.5 years (mean duration, 3.5 years) after microfracture (n = 12) or conservative (n = 16) treatment for type II OCL. Clinical outcomes were considered good with an American Orthopedic Foot and Ankle Society score ≥80. The T 1 /T 2 -values and indices of repair tissue (RT; cartilage above the OCL) were compared to those of the adjacent normal cartilage (NC) by region-of-interest analysis. The ability of the two methods to discriminate RT from NC was determined by area under the receiver operating characteristics curve (AUC) analysis. The Youden index was maximized for T 1 /T 2 measures for identifying cutoff values indicative of good/poor clinical outcomes. Repair tissue exhibited lower dGEMRIC values (629.83 vs. 738.51 msec) and higher T 2 values (62.07 vs. 40.69 msec) than NC (P < 0.001). T 2 mapping exhibited greater AUC than dGEMRIC (0.88 vs. 0.69; P = 0.0398). All T 1 measures exhibited higher maximized Youden indices than the corresponding T 2 measures. The highest maximized Youden index for T 1difference was observed at a cutoff value of 84 msec (sensitivity, 78%; specificity, 83%). While T 2 mapping is superior to dGEMRIC in discriminating RT, the latter better identifies good/poor clinical outcomes in patients with type II talar OCL. 2 Technical Efficacy: Stage 3 J. Magn. Reson. Imaging 2017;46:1601-1610. © 2017 International Society for Magnetic Resonance in Medicine.

  8. Intra-articular Diagnostic Injection Exhibits Poor Predictive Value for Outcome After Hip Arthroscopy.

    PubMed

    Krych, Aaron J; Sousa, Paul L; King, Alexander H; Engasser, William M; Levy, Bruce A

    2016-08-01

    from injection to surgery was 3 (range, <1 to 20) months. Outcome scores were obtained at a mean 14.8 (range, 11 to 30) months after arthroscopic surgery. Postoperative mean Modified Harris Hip Score, HOS activities of daily living, and HOS-Sport scores were 79.2 ± 17.3, 82.6 ± 17.3, and 67.4 ± 28.2, respectively. There was no statistical correlation between percent pain relief and outcome. There was no significant difference in outcome scores between those with ≤50% and >50% pain relief. Multivariate regression analysis showed no significant predictors of outcome, including age, gender, Tonnis grade, percent relief with IA injection, or type of surgery. In this study of patients undergoing hip arthroscopy for labral pathology, our data indicate that the amount of pain relief from IA injection may be a poor predictor of short-term outcome, even when adjusting for chondral degeneration. Although anesthetic injections can be an important diagnostic tool in select patients, a combination of the clinical history, physical examination, and imaging findings is fundamental. Level IV, therapeutic case series. Copyright © 2016 Arthroscopy Association of North America. Published by Elsevier Inc. All rights reserved.

  9. A randomized clinical trial aimed at preventing poor psychosocial and glycemic outcomes in teens with type 1 diabetes (T1D)

    PubMed Central

    Weissberg-Benchell, Jill; Rausch, Joseph; Iturralde, Esti; Jedraszko, Aneta; Hood, Korey

    2016-01-01

    Adolescents with type 1 diabetes have an increased risk for a variety of emotional and behavioral challenges as well as negative diabetes outcomes. This study was designed to compare the effectiveness of a depression-prevention, resilience promotion program with an advanced diabetes education program. Each program consisted of 9 group-based sessions. There were 264 adolescents enrolled in this multi-site randomized clinical trial. The primary outcomes were depressive symptoms and glycemic control; secondary outcomes included resilience skills, diabetes management and adherence, and diabetes-specific distress. The goal of the present paper is to describe the study design, the intervention, and the baseline characteristics of the sample. Preliminary data suggests that enrollment, randomization and retention were successful. Longitudinal follow-up and examination of mechanisms of action as they relate to psychosocial and glycemic outcomes will be explored in the future. PMID:27267154

  10. Markers of neuroinflammation and neuronal injury in bipolar disorder: Relation to prospective clinical outcomes.

    PubMed

    Isgren, Anniella; Sellgren, Carl; Ekman, Carl-Johan; Holmén-Larsson, Jessica; Blennow, Kaj; Zetterberg, Henrik; Jakobsson, Joel; Landén, Mikael

    2017-10-01

    Neuroimmune mechanisms have been linked to the pathophysiology of bipolar disorder based on studies of biomarkers in plasma, cerebrospinal fluid (CSF), and postmortem brain tissue. There are, however, no longitudinal studies investigating if CSF markers of neuroinflammation and neuronal injury predict clinical outcomes in patients with bipolar disorder. We have in previous studies found higher CSF concentrations of interleukin-8 (IL-8), monocyte chemoattractant protein 1 (MCP-1/CCL-2), chitinase-3-like protein 1 (CHI3L1/YKL-40), and neurofilament light chain (NF-L) in euthymic patients with bipolar disorder compared with controls. Here, we investigated the relationship of these CSF markers of neuroinflammation and neuronal injury with clinical outcomes in a prospective study. 77 patients with CSF analyzed at baseline were followed for 6-7years. Associations of baseline biomarkers with clinical outcomes (manic/hypomanic and depressive episodes, suicide attempts, psychotic symptoms, inpatient care, GAF score change) were investigated. Baseline MCP-1 concentrations were positively associated with manic/hypomanic episodes and inpatient care during follow-up. YKL-40 concentrations were negatively associated with manic/hypomanic episodes and with occurrence of psychotic symptoms. The prospective negative association between YKL-40 and manic/hypomanic episodes survived multiple testing correction. Concentrations of IL-8 and NF-L were not associated with clinical outcomes. High concentrations of these selected CSF markers of neuroinflammation and neuronal injury at baseline were not consistently associated with poor clinical outcomes in this prospective study. The assessed proteins may be involved in adaptive immune processes or reflect a state of vulnerability for bipolar disorder rather than being of predictive value for disease progression. Copyright © 2017 Elsevier Inc. All rights reserved.

  11. Dehydroepiandrosterone (DHEA) supplementation and IVF outcome in poor responders.

    PubMed

    Triantafyllidou, Olga; Sigalos, George; Vlahos, Nikos

    2017-06-01

    Ovarian stimulation of poor ovarian responders still remains a challenging issue. The incidence of poor responders among infertile women is reported in 9-24% IVF cycles and is associated with very low clinical pregnancy rates. Different treatments have been reported in the literature in an attempt to identify the best stimulation protocol for those patients. Administration of dehydroepiandrosterone acetate (DHEA) was suggested as a promising treatment. It is well known that androgens can influence ovarian follicular growth, augment steroidogenesis, promote follicular recruitment and increase the number of primary and pre-antral follicles. The purpose of this review is to evaluate the effect of DHEA supplementation on women with diminished ovarian reserve. Because of the uncertainty of published data, we suggest that well-designed multicentre RCTs are required to provide more insight on the effectiveness of DHEA. The absence of significant side effects should not be considered as an argument to support DHEA treatment.

  12. Improving cognitive outcome in cerebral malaria: insights from clinical and experimental research.

    PubMed

    de Miranda, Aline Silva; Brant, Fátima; Machado, Fabiana Simão; Rachid, Milene Alvarenga; Teixeira, Antônio Lúcio

    2011-12-01

    Cerebral Malaria (CM) is a clinical syndrome defined by the World Health Organization (WHO) as a potentially reversible diffuse encephalopathy characterized mainly by coma and the presence of asexual forms of Plasmodium falciparum parasites in peripheral blood smears in the absence of other causes of encephalopathy. A wide range of clinical manifestations follows the disease including cognitive, behavioral and motor dysfunctions, seizures and coma. The underlying mechanisms of CM pathogenesis remain incompletely understood although vascular, immunological and metabolic changes have been described. The classical treatment of CM is based on the administration of antimalarial drugs, especially chloroquine and artemisinin derivates as artesunate. Even with treatment, 15 to 20% of children with CM die and approximately 10 to 17% of those who survive remain with significant long-term cognitive impairment. In this context, neuroprotective and adjuvant therapies have been recently investigated in clinical and experimental studies of CM in an attempt to improve cognitive outcome. A poor understanding of pathophysiological mechanisms, properties of compounds used and patient selection have contributed to the lack of success of these interventions. This review discusses clinical aspects of cognitive sequelae, possible mechanisms involved in the brain injury, perspectives and limitations regarding the pharmacological strategies to improve cognitive outcome in CM.

  13. Mannose-binding lectin-associated serine protease 2 (MASP-2) contributes to poor disease outcome in humans and mice with pneumococcal meningitis.

    PubMed

    Kasanmoentalib, E Soemirien; Valls Seron, Mercedes; Ferwerda, Bart; Tanck, Michael W; Zwinderman, Aeilko H; Baas, Frank; van der Ende, Arie; Brouwer, Matthijs C; van de Beek, Diederik

    2017-01-03

    Pneumococcal meningitis is the most common and severe form of bacterial meningitis. Fatality rates are substantial, and long-term sequelae develop in about half of survivors. Disease outcome has been related to the severity of the pro-inflammatory response in the subarachnoid space. The complement system, which mediates key inflammatory processes, has been implicated as a modulator of pneumococcal meningitis disease severity in animal studies. We investigated mannose-binding lectin-associated serine protease (MASP-2) levels in cerebrospinal fluid (CSF) samples derived from the diagnostic lumbar puncture, which was available for 307 of 792 pneumococcal meningitis episodes included in our prospective nationwide cohort study (39%), and the association between these levels and clinical outcome. Subsequently, we studied the role of MASP-2 in our experimental pneumococcal meningitis mouse model using Masp2 -/- mice and evaluated the potential of adjuvant treatment with MASP-2-specific monoclonal antibodies in wild-type (WT) mice. MASP-2 levels in cerebrospinal fluid of patients with bacterial meningitis were correlated with poor functional outcome. Consistent with these human data, Masp2-deficient mice with pneumococcal meningitis had lower cytokine levels and increased survival compared to WT mice. Adjuvant treatment with MASP-2-specific monoclonal antibodies led to reduced complement activation and decreased disease severity. MASP-2 contributes to poor disease outcome in human and mice with pneumococcal meningitis. MASP-2-specific monoclonal antibodies can be used to attenuate the inflammatory response in pneumococcal meningitis.

  14. Timing of operation for poor-grade aneurysmal subarachnoid hemorrhage: study protocol for a randomized controlled trial

    PubMed Central

    2013-01-01

    Background Subarachnoid hemorrhage is a common and dangerous disease with an unfavorable prognosis. Patients with poor-grade subarachnoid hemorrhage (Hunt & Hess Grades 4–5) are unconscious on admission. Because of the high mortality and disability rate associated with poor-grade subarachnoid hemorrhage, it is often treated conservatively. Timing of surgery for poor-grade aneurysmal subarachnoid hemorrhage is still controversial, therefore this study aims to identify the optimal time to operate on patients admitted in poor clinical condition. Methods/design Ninety-nine patients meeting the inclusion criteria were randomly assigned into three treatment groups. The early surgery group received operation within 3 days after onset of subarachnoid hemorrhage (day of SAH = day 1); the intermediate surgery group received operation from days 4 to 7, and surgery was performed on the late surgery group after day 7. Follow-up was performed 1, 3, and 6 months after aneurysm clipping. Primary indicators of outcome included the Extended Glasgow Outcome Scale and the Modified Rankin Scale, while secondary indicators of outcome were assessed using the Barthel Index and mortality. Discussion This is the first prospective, single-center, observer-blinded, randomized controlled trial to elucidate optimal timing for surgery in poor-grade subarachnoid hemorrhage patients. The results of this study will be used to direct decisions of surgical intervention in poor-grade subarachnoid hemorrhage, thus improving clinical outcomes for patients. Trial registration Chinese Clinical Trial Registry: ChiCTR-TRC-12002917 PMID:23957458

  15. International peripheral T-cell and natural killer/T-cell lymphoma study: pathology findings and clinical outcomes.

    PubMed

    Vose, Julie; Armitage, James; Weisenburger, Dennis

    2008-09-01

    Peripheral T-cell lymphoma (PTCL) and natural killer/T-cell lymphoma (NKTCL) are rare and heterogeneous forms of non-Hodgkin's lymphoma (NHL) that, in general, are associated with a poor clinical outcome. A cohort of 1,314 cases of PTCL and NKTCL was organized from 22 centers worldwide, consisting of patients with previously untreated PTCL or NKTCL who were diagnosed between 1990 and 2002. Tissue biopsies, immunophenotypic markers, molecular genetic studies, and clinical information from consecutive patients at each site were reviewed by panels of four expert hematopathologists and classified according to the WHO classification. A diagnosis of PTCL or NKTCL was confirmed in 1,153 (87.8%) of the cases. The most common subtypes were PTCL not otherwise specified (NOS; 25.9%), angioimmunoblastic type (18.5%), NKTCL (10.4%), and adult T-cell leukemia/lymphoma (ATLL; 9.6%). Misclassification occurred in 10.4% of the cases including Hodgkin's lymphoma (3%), B-cell lymphoma (1.4%), unclassifiable lymphoma (2.8%), or a diagnosis other than lymphoma (2.3%). We found marked variation in the frequency of the various subtypes by geographic region. The use of an anthracycline-containing regimen was not associated with an improved outcome in PTCL-NOS or angioimmunoblastic type, but was associated with an improved outcome in anaplastic large-cell lymphoma, ALK positive. The WHO classification is useful for defining subtypes of PTCL and NKTCL. However, expert hematopathology review is important for accurate diagnosis. The clinical outcome for patients with most of these lymphoma subtypes is poor with standard therapies, and novel agents and new modalities are needed to improve survival.

  16. Assessment of cataract surgical outcomes in settings where follow-up is poor: PRECOG, a multicentre observational study.

    PubMed

    Congdon, Nathan; Yan, Xixi; Lansingh, Van; Sisay, Alemayehu; Müller, Andreas; Chan, Ving; Jin, Ling; Meltzer, Mirjam E; Karumanchi, Sasipriya M; Guan, Chunhong; Vuong, Quy; Rivera, Nelson; McCleod-Omawale, Joan; He, Mingguang

    2013-07-01

    Poor follow-up after cataract surgery in developing countries makes assessment of operative quality uncertain. We aimed to assess two strategies to measure visual outcome: recording the visual acuity of all patients 3 or fewer days postoperatively (early postoperative assessment), and recording that of only those patients who returned for the final follow-up examination after 40 or more days without additional prompting. Each of 40 centres in ten countries in Asia, Africa, and Latin America recruited 40-120 consecutive surgical cataract patients. Operative-eye best-corrected visual acuity and uncorrected visual acuity were recorded before surgery, 3 or fewer days postoperatively, and 40 or more days postoperatively. Clinics logged whether each patient had returned for the final follow-up examination without additional prompting, had to be actively encouraged to return, or had to be examined at home. Visual outcome for each centre was defined as the proportion of patients with uncorrected visual acuity of 6/18 or better minus the proportion with uncorrected visual acuity of 6/60 or worse, and was calculated for each participating hospital with results from the early assessment of all patients and the late assessment of only those returning unprompted, with results from the final follow-up assessment for all patients used as the standard. Of 3708 participants, 3441 (93%) had final follow-up vision data recorded 40 or more days after surgery, 1831 of whom (51% of the 3581 total participants for whom mode of follow-up was recorded) had returned to the clinic without additional prompting. Visual outcome by hospital from early postoperative and final follow-up assessment for all patients were highly correlated (Spearman's rs=0·74, p<0·0001). Visual outcome from final follow-up assessment for all patients and for only those who returned without additional prompting were also highly correlated (rs=0·86, p<0·0001), even for the 17 hospitals with unprompted return rates

  17. Downregulation of TES by hypermethylation in glioblastoma reduces cell apoptosis and predicts poor clinical outcome.

    PubMed

    Bai, Yu; Zhang, Quan-Geng; Wang, Xin-Hua

    2014-12-11

    Gliomas are the most common human brain tumors. Glioblastoma, also known as glioblastoma multiform (GBM), is the most aggressive, malignant, and lethal glioma. The investigation of prognostic and diagnostic molecular biomarkers in glioma patients to provide direction on clinical practice is urgent. Recent studies demonstrated that abnormal DNA methylation states play a key role in the pathogenesis of this kind of tumor. In this study, we want to identify a novel biomarker related to glioma initiation and find the role of the glioma-related gene. We performed a methylation-specific microarray on the promoter region to identify methylation gene(s) that may affect outcome of GBM patients. Normal and GBM tissues were collected from Tiantan Hospital. Genomic DNA was extracted from these tissues and analyzed with a DNA promoter methylation microarray. Testis derived transcript (TES) protein expression was analyzed by immunohistochemistry in paraffin-embedded patient tissues. Western blotting was used to detect TES protein expression in the GBM cell line U251 with or without 5-aza-dC treatment. Cell apoptosis was evaluated by flow cytometry analysis using Annexin V/PI staining. We found that the TES promoter was hypermethylated in GBM compared to normal brain tissues under DNA promoter methylation microarray analysis. The GBM patients with TES hypermethylation had a short overall survival (P <0.05, log-rank test). Among GBM samples, reduced TES protein level was detected in 33 (89.2%) of 37 tumor tissues by immunohistochemical staining. Down regulation of TES was also correlated with worse patient outcome (P <0.05, log-rank test). Treatment on the GBM cell line U251 with 5-aza-dC can greatly increase TES expression, confirming the hypermethylation of TES promoter in GBM. Up-regulation of TES prompts U251 apoptosis significantly. This study demonstrated that both TES promoter hypermethylation and down-regulated protein expression significantly correlated with worse

  18. Severe disease presentation and poor outcomes among pediatric systemic lupus erythematosus patients in South Africa

    PubMed Central

    Lewandowski, Laura B; Schanberg, Laura E; Thielman, Nathan; Phuti, Angel; Kalla, Asgar A; Okpechi, Ikechi; Nourse, Peter; Gajjar, Priya; Faller, Gail; Ambaram, Priya; Reuter, Helmuth; Spittal, Graeme; Scott, Christiaan

    2016-01-01

    severe lupus nephritis and poor renal outcomes compared to North American peers. Our study reveals a severe disease phenotype in the PULSE cohort resulting in poor outcomes in this high-risk population. PMID:27488473

  19. Severe disease presentation and poor outcomes among pediatric systemic lupus erythematosus patients in South Africa.

    PubMed

    Lewandowski, L B; Schanberg, L E; Thielman, N; Phuti, A; Kalla, A A; Okpechi, I; Nourse, P; Gajjar, P; Faller, G; Ambaram, P; Reuter, H; Spittal, G; Scott, C

    2017-02-01

    at enrolment in the South African registry. South African patients have severe lupus nephritis and poor renal outcomes compared to North American peers. Our study revealed a severe disease phenotype in the PULSE cohort resulting in poor outcomes in this high-risk population.

  20. A systematic review of studies identifying predictors of poor return to work outcomes following workplace injury.

    PubMed

    Street, Tamara D; Lacey, Sarah J

    2015-06-05

    Injuries occurring in the workplace can have serious implications for the health of the individual, the productivity of the employer and the overall economic community. The objective of this paper is to increase the current state of understanding of individual demographic and psychosocial characteristics associated with extended absenteeism from the workforce due to a workplace injury. Studies included in this systematic literature review tracked participants' return to work status over a minimum of three months, identified either demographic, psychosocial or general injury predictors of poor return to work outcomes and included a heterogeneous sample of workplace injuries. Identified predictors of poor return to work outcomes included older age, female gender, divorced marital status, two or more dependent family members, lower education levels, employment variables associated with reduced labour market desirability, severity or sensitive injury locations, negative attitudes and outcome perceptions of the participant. There is a need for clear and consistent definition and measurement of return to work outcomes and a holistic theoretical model integrating injury, psychosocial and demographic predictors of return to work. Through greater understanding of the nature of factors affecting return to work, improved outcomes could be achieved.

  1. Glomerular Immune Deposits Are Predictive of Poor Long-Term Outcome in Patients with Adult Biopsy-Proven Minimal Change Disease: A Cohort Study in Korea

    PubMed Central

    Lee, Sung Woo; YU, Mi-Yeon; Baek, Seon Ha; Ahn, Shin-Young; Kim, Sejoong; Na, Ki Young; Chae, Dong-Wan; Chin, Ho Jun

    2016-01-01

    Background and Objectives There has been little published information on risk factors for poor long-term outcome in adult biopsy-proven minimal change disease (MCD). Methods Data from sixty-three adult, biopsy-proven primary MCD patients treated at a tertiary university hospital between 2003 and 2013 were analyzed. Baseline clinical and pathologic factors were assessed for the associations with composite outcome of creatinine doubling, end stage renal disease, or all-cause mortality. Results During a median (interquartile) 5.0 (2.8–5.0) years, the composite outcome occurred in 11.1% (7/63) of patients. The rate of glomerular immune deposits was 23.8% (15/63). Patients with glomerular immune deposits showed a significantly lower urine protein creatinine ratio than those without deposits (P = 0.033). The rate of non-responders was significantly higher in patients with glomerular immune deposits than in those without deposits (P = 0.033). In patients with deposits, 26.7% (4/15) developed the composite outcome, while only 6.3% (3/48) developed the composite outcome among those without deposits (P = 0.049). In multivariate Cox proportional hazards regression analysis, the presence of glomerular immune deposits was the only factor associated with development of the composite outcome (hazard ratio: 2.310, 95% confidence interval: 1.031–98.579, P = 0.047). Conclusion Glomerular immune deposits were associated with increased risk of a composite outcome in adult MCD patients. The higher rate of non-responders in patients with deposits might be related to the poor outcome. Future study is needed. PMID:26799663

  2. Correlates of low back pain outcomes in a community clinic.

    PubMed

    Lowdermilk, A; Panus, P C; Kalbfleisch, J H

    1999-08-01

    Both governmental and private agencies have focused on the multiple outcome variables that may affect patient treatment. Our investigation examined treatment-independent outcome variables and correlates in patients with the sole complaint of low back pain. Treatment was conducted in an outpatient physical therapy clinic serving a rural/suburban Tennessee population. The review collected data on nine variables from 54 clinic records. The study group was 56% female, with ages for all subjects ranging from 26 to 84 years. Twenty-five patients carried private insurance, 14 were TennCare recipients (state Medicaid), 9 were covered by workers compensation, and 6 were Medicare based. The prescribed number of treatment sessions (Rx) varied from 1 to 3 visits to as many as 18. The Rx was not related to sex, age, or payer type. The compliance index (Cx) (mean = 76.3%, range = 6% to 150%) was related to payer type (P < .02), but not related to sex, age, or Rx. TennCare patients had lower compliance levels (mean Cx = 51.1) than all other insurer groups combined (mean Cx = 85.0). Self-assessed improvement by the patient (Patient Status) was related to Cx (P < 0.005) but not sex, age, payer type, or Rx. Completion by the patient of long-term physical therapy goals as determined by the therapist was related to Cx (P < .03) and self-assessed patient status (P < .02), while disposition at discharge was associated with Cx, self-assessed patient status, and payer type (P < .001). Compliance by patients significantly influences the outcome measures of self-assessed improvement, therapist assessment of achieving long-term treatment goals, and disposition at discharge. TennCare patients demonstrated both low compliance and poor outcome at discharge. These results suggest that the lower potential for positive treatment outcome may exist for the TennCare patient population.

  3. Poorly Performing Physicians: Does the Script Concordance Test Detect Bad Clinical Reasoning?

    ERIC Educational Resources Information Center

    Goulet, Francois; Jacques, Andre; Gagnon, Robert; Charlin, Bernard; Shabah, Abdo

    2010-01-01

    Introduction: Evaluation of poorly performing physicians is a worldwide concern for licensing bodies. The College des Medecins du Quebec currently assesses the clinical competence of physicians previously identified with potential clinical competence difficulties through a day-long procedure called the Structured Oral Interview (SOI). Two peer…

  4. T-cell exhaustion, co-stimulation and clinical outcome in autoimmunity and infection.

    PubMed

    McKinney, Eoin F; Lee, James C; Jayne, David R W; Lyons, Paul A; Smith, Kenneth G C

    2015-07-30

    The clinical course of autoimmune and infectious disease varies greatly, even between individuals with the same condition. An understanding of the molecular basis for this heterogeneity could lead to significant improvements in both monitoring and treatment. During chronic infection the process of T-cell exhaustion inhibits the immune response, facilitating viral persistence. Here we show that a transcriptional signature reflecting CD8 T-cell exhaustion is associated with poor clearance of chronic viral infection, but conversely predicts better prognosis in multiple autoimmune diseases. The development of CD8 T-cell exhaustion during chronic infection is driven both by persistence of antigen and by a lack of accessory 'help' signals. In autoimmunity, we find that where evidence of CD4 T-cell co-stimulation is pronounced, that of CD8 T-cell exhaustion is reduced. We can reproduce the exhaustion signature by modifying the balance of persistent stimulation of T-cell antigen receptors and specific CD2-induced co-stimulation provided to human CD8 T cells in vitro, suggesting that each process plays a role in dictating outcome in autoimmune disease. The 'non-exhausted' T-cell state driven by CD2-induced co-stimulation is reduced by signals through the exhaustion-associated inhibitory receptor PD-1, suggesting that induction of exhaustion may be a therapeutic strategy in autoimmune and inflammatory disease. Using expression of optimal surrogate markers of co-stimulation/exhaustion signatures in independent data sets, we confirm an association with good clinical outcome or response to therapy in infection (hepatitis C virus) and vaccination (yellow fever, malaria, influenza), but poor outcome in autoimmune and inflammatory disease (type 1 diabetes, anti-neutrophil cytoplasmic antibody-associated vasculitis, systemic lupus erythematosus, idiopathic pulmonary fibrosis and dengue haemorrhagic fever). Thus, T-cell exhaustion plays a central role in determining outcome in

  5. Is a high initial World Federation of Neurosurgery (WFNS) grade really associated with a poor clinical outcome in elderly patients with ruptured intracranial aneurysms treated with coiling?

    PubMed

    Iosif, Christina; Di Maria, Federico; Sourour, Nader; Degos, Vincent; Bonneville, Fabrice; Biondi, Alessandra; Jean, Betty; Colonne, Chantal; Nouet, Aurelien; Chiras, Jacques; Clarençon, Frédéric

    2014-05-01

    Coiling of ruptured intracranial aneurysms in elderly patients remains debatable in terms of technical feasibility and clinical outcome. In this observational cohort study we aimed to assess the technical feasibility, complication profile and clinical outcomes of elderly patients with subarachnoid hemorrhage (SAH) treated with endovascular therapy. The study included 59 consecutive patients (47 women) aged ≥70 years (mean age 76 years, range 71-84) admitted to our institution with SAH from January 2002 to July 2011. The patients were treated for 66 aneurysms (regular coiling: n=62 (94%), balloon-assisted technique: n=2 (3%), stent and coil technique: n=2 (3%)). World Federation of Neurosurgery (WFNS) grade at admission was 1 in 13 patients, 2 in 23 patients, 3 in 8 patients, 4 in 11 patients and 5 in 4 patients. We analysed data by univariate and multivariate statistical analyses with an emphasis on the initial clinical situation, complications and clinical outcome. The technical success rate was 98% with a procedure-related deficit rate of 10% and procedure-related death rate of 5%. The Glasgow Outcome Scale score at 6 months was 1 in 15 patients (25.4%), 2 in 8 patients (13.6%), 3 in 14 patients (23.7%), 4 in 11 patients (18.6%) and 5 in 11 patients (18.6%). Patients admitted with a high initial WFNS grade did not differ statistically in terms of clinical outcome. The final clinical outcome was not significantly correlated with age, initial Fisher score or procedure-related complications. Endovascular treatment of elderly patients with ruptured cerebral aneurysms is feasible, safe and beneficial regardless of the presenting WFNS score.

  6. Clinical Profile and Visual Outcome of Ocular Bartonellosis in Malaysia

    PubMed Central

    Tan, Chai Lee; Fhun, Lai Chan; Abdul Gani, Nor Hasnida; Muhammed, Julieana; Tuan Jaafar, Tengku Norina

    2017-01-01

    Background. Ocular bartonellosis can present in various ways, with variable visual outcome. There is limited data on ocular bartonellosis in Malaysia. Objective. We aim to describe the clinical presentation and visual outcome of ocular bartonellosis in Malaysia. Materials and Methods. This was a retrospective review of patients treated for ocular bartonellosis in two ophthalmology centers in Malaysia between January 2013 and December 2015. The diagnosis was based on clinical features, supported by a positive Bartonella spp. serology. Results. Of the 19 patients in our series, females were predominant (63.2%). The mean age was 29.3 years. The majority (63.2%) had unilateral involvement. Five patients (26.3%) had a history of contact with cats. Neuroretinitis was the most common presentation (62.5%). Azithromycin was the antibiotic of choice (42.1%). Concurrent systemic corticosteroids were used in approximately 60% of cases. The presenting visual acuity was worse than 6/18 in approximately 60% of eyes; on final review, 76.9% of eyes had a visual acuity better than 6/18. Conclusion. Ocular bartonellosis tends to present with neuroretinitis. Azithromycin is a viable option for treatment. Systemic corticosteroids may be considered in those with poor visual acuity on presentation. PMID:28265290

  7. Presentation and outcome of clinical poor performance in one health district over a 5-year period: 2002–2007

    PubMed Central

    Cox, Stephen J; Holden, John D

    2009-01-01

    Background The detection, assessment, and management of primary care poor performance raise difficult issues for all those involved. Guidance has largely focused on managing the most serious cases where patient safety is severely compromised. The management of primary care poor performance has become an increasingly important part of primary care trust (PCT) work, but its modes of presentation and prevalence are not well known. Aim To report the prevalence, presentation modes, and management of primary care poor performance cases presenting to one PCT over a 5-year period. Design of study A retrospective review of primary care poor performance cases in one district. Setting St Helens PCT administered 35 practices with 130 GPs on the performers list, caring for 190 110 patients in North West England, UK. Method Cases presenting during 2002–2007 were initially reviewed by the chair of the PCT clinical executive committee. Anonymised data were then jointly reviewed by the assessor and another experienced GP advisor. Results There were 102 individual presentations (20 per year or one every 2–3 weeks) where clinician performance raised significant cause for concern occurred over the 5-year period. These concerns related to 37 individual clinicians, a range of 1–14 per clinician (mean 2.7). Whistleblowing by professional colleagues on 43 occasions was the most common presentation, of which 26 were from GPs about GPs. Patient complaints (18) were the second most common presentation. Twenty-seven clinicians were GPs, of whom the General Medical Council (GMC) were notified or involved in 13 cases. Clinicians were supported locally, and remedying was exclusively locally managed in 14 cases, and shared with an external organisation (such as the GMC or deanery) in another 12. Conclusion Professional whistleblowing and patient complaints were the most common sources of presentation. Effective PCT teams are needed to manage clinicians whose performance gives cause for

  8. Perioperative factors predicting poor outcome in elderly patients following emergency general surgery: a multivariate regression analysis.

    PubMed

    Lees, Mackenzie C; Merani, Shaheed; Tauh, Keerit; Khadaroo, Rachel G

    2015-10-01

    Older adults (≥ 65 yr) are the fastest growing population and are presenting in increasing numbers for acute surgical care. Emergency surgery is frequently life threatening for older patients. Our objective was to identify predictors of mortality and poor outcome among elderly patients undergoing emergency general surgery. We conducted a retrospective cohort study of patients aged 65-80 years undergoing emergency general surgery between 2009 and 2010 at a tertiary care centre. Demographics, comorbidities, in-hospital complications, mortality and disposition characteristics of patients were collected. Logistic regression analysis was used to identify covariate-adjusted predictors of in-hospital mortality and discharge of patients home. Our analysis included 257 patients with a mean age of 72 years; 52% were men. In-hospital mortality was 12%. Mortality was associated with patients who had higher American Society of Anesthesiologists (ASA) class (odds ratio [OR] 3.85, 95% confidence interval [CI] 1.43-10.33, p = 0.008) and in-hospital complications (OR 1.93, 95% CI 1.32-2.83, p = 0.001). Nearly two-thirds of patients discharged home were younger (OR 0.92, 95% CI 0.85-0.99, p = 0.036), had lower ASA class (OR 0.45, 95% CI 0.27-0.74, p = 0.002) and fewer in-hospital complications (OR 0.69, 95% CI 0.53-0.90, p = 0.007). American Society of Anesthesiologists class and in-hospital complications are perioperative predictors of mortality and disposition in the older surgical population. Understanding the predictors of poor outcome and the importance of preventing in-hospital complications in older patients will have important clinical utility in terms of preoperative counselling, improving health care and discharging patients home.

  9. Germline BRCA mutations are associated with higher risk of nodal involvement, distant metastasis, and poor survival outcomes in prostate cancer.

    PubMed

    Castro, Elena; Goh, Chee; Olmos, David; Saunders, Ed; Leongamornlert, Daniel; Tymrakiewicz, Malgorzata; Mahmud, Nadiya; Dadaev, Tokhir; Govindasami, Koveela; Guy, Michelle; Sawyer, Emma; Wilkinson, Rosemary; Ardern-Jones, Audrey; Ellis, Steve; Frost, Debra; Peock, Susan; Evans, D Gareth; Tischkowitz, Marc; Cole, Trevor; Davidson, Rosemarie; Eccles, Diana; Brewer, Carole; Douglas, Fiona; Porteous, Mary E; Donaldson, Alan; Dorkins, Huw; Izatt, Louise; Cook, Jackie; Hodgson, Shirley; Kennedy, M John; Side, Lucy E; Eason, Jacqueline; Murray, Alex; Antoniou, Antonis C; Easton, Douglas F; Kote-Jarai, Zsofia; Eeles, Rosalind

    2013-05-10

    To analyze the baseline clinicopathologic characteristics of prostate tumors with germline BRCA1 and BRCA2 (BRCA1/2) mutations and the prognostic value of those mutations on prostate cancer (PCa) outcomes. This study analyzed the tumor features and outcomes of 2,019 patients with PCa (18 BRCA1 carriers, 61 BRCA2 carriers, and 1,940 noncarriers). The Kaplan-Meier method and Cox regression analysis were used to evaluate the associations between BRCA1/2 status and other PCa prognostic factors with overall survival (OS), cause-specific OS (CSS), CSS in localized PCa (CSS_M0), metastasis-free survival (MFS), and CSS from metastasis (CSS_M1). PCa with germline BRCA1/2 mutations were more frequently associated with Gleason ≥ 8 (P = .00003), T3/T4 stage (P = .003), nodal involvement (P = .00005), and metastases at diagnosis (P = .005) than PCa in noncarriers. CSS was significantly longer in noncarriers than in carriers (15.7 v 8.6 years, multivariable analyses [MVA] P = .015; hazard ratio [HR] = 1.8). For localized PCa, 5-year CSS and MFS were significantly higher in noncarriers (96% v 82%; MVA P = .01; HR = 2.6%; and 93% v 77%; MVA P = .009; HR = 2.7, respectively). Subgroup analyses confirmed the poor outcomes in BRCA2 patients, whereas the role of BRCA1 was not well defined due to the limited size and follow-up in this subgroup. Our results confirm that BRCA1/2 mutations confer a more aggressive PCa phenotype with a higher probability of nodal involvement and distant metastasis. BRCA mutations are associated with poor survival outcomes and this should be considered for tailoring clinical management of these patients.

  10. Poor glycemic control in younger women attending Malaysian public primary care clinics: findings from adults diabetes control and management registry.

    PubMed

    Cheong, Ai Theng; Lee, Ping Yein; Sazlina, Shariff-Ghazali; Mohamad Adam, Bujang; Chew, Boon How; Mastura, Ismail; Jamaiyah, Haniff; Syed Alwi, Syed-Abdul-Rahman; Sri Wahyu, Taher; Nafiza, Mat-Nasir

    2013-12-10

    Women of reproductive age are a group of particular concern as diabetes may affect their pregnancy outcome as well as long-term morbidity and mortality. This study aimed to compare the clinical profiles and glycemic control of reproductive and non-reproductive age women with type 2 diabetes (T2D) in primary care settings, and to determine the associated factors of poor glycemic control in the reproductive age group women. This was a cross-sectional study using cases reported by public primary care clinics to the Adult Diabetes Control and Management registry from 1st January to 31st December 2009. All Malaysian women aged 18 years old and above and diagnosed with T2D for at least 1 year were included in the analysis. The target for glycemic control (HbA1c < 6.5%) is in accordance to the recommended national guidelines. Both univariate and multivariate approaches of logistic regression were applied to determine whether reproductive age women have an association with poor glycemic control. Data from a total of 30,427 women were analyzed and 21.8% (6,622) were of reproductive age. There were 12.5% of reproductive age women and 18.0% of non-reproductive age women that achieved glycemic control. Reproductive age group women were associated with poorer glycemic control (OR = 1.5, 95% CI = 1.2-1.8). The risk factors associated with poor glycemic control in the reproductive age women were being of Malay and Indian race, longer duration of diabetes, patients on anti-diabetic agents, and those who had not achieved the target total cholesterol and triglycerides. Women with T2D have poor glycemic control, but being of reproductive age was associated with even poorer control. Health care providers need to pay more attention to this group of patients especially for those with risk factors. More aggressive therapeutic strategies to improve their cardiometabolic control and pregnancy outcome are warranted.

  11. A systematic review of clinical outcomes in surgical treatment of adult isthmic spondylolisthesis.

    PubMed

    Noorian, Shaya; Sorensen, Karen; Cho, Woojin

    2018-05-07

    study compared circumferential fusion to PLF + PS. 3 studies compared clinical outcomes among different IF + PS techniques (ALIF + PS vs. PLIF + PS vs TLIF + PS) without PLF. As per the Cochrane Collaboration's risk of bias assessment tool, 4 randomized clinical trials had an overall low risk of bias, 1 randomized clinical trial had an unclear risk of bias, and 1 randomized clinical trial had a high risk of bias. As per the Newcastle-Ottawa scale, 3 observational studies were of overall good quality, 4 observational studies were of fair quality, and 2 observational studies were of poor quality. Available studies provide strong evidence that the addition of reduction to fusion does not result in better clinical outcomes of pain and function in low-grade isthmic spondylolisthesis. Evidence also suggests that there is no significant difference between interbody fusion (IF + PS) and posterior fusion (PLF +/- PS) in outcomes of pain, function, and complication rates at follow-up points up to approximately 3 years in cases of low-grade slips. However, studies with longer follow-up points suggest that interbody fusion (IF + PS) may perform better in these same measures at later follow-up points. Available evidence also suggests no difference between circumferential fusion (IF + PS + PLF) and interbody fusion (IF + PS) in outcomes of pain and function in low-grade slips, but circumferential fusion has been associated with greater intraoperative blood loss, longer surgery duration, and longer hospital stays. In terms of clinical outcomes, insufficient evidence is available to assess the utility of adding PS to PLF, the relative efficacy of different interbody fusion (IF + PS) techniques (ALIF + PS vs. TLIF + PS vs. PLIF + PS), and the relative efficacy of circumferential fusion and posterior fusion (PLF + PS). Copyright © 2018. Published by Elsevier Inc.

  12. Strengthening health human resources and improving clinical outcomes through an integrated guideline and educational outreach in resource-poor settings: a cluster-randomized trial.

    PubMed

    Schull, Michael J; Banda, Hastings; Kathyola, Damson; Fairall, Lara; Martiniuk, Alexandra; Burciul, Barry; Zwarenstein, Merrick; Sodhi, Sumeet; Thompson, Sandy; Joshua, Martias; Mondiwa, Martha; Bateman, Eric

    2010-12-03

    In low-income countries, only about a third of Human Immunodeficiency Virus/Acquired Immune Deficiency Syndrome (HIV/AIDS) patients eligible for anti-retroviral treatment currently receive it. Providing decentralized treatment close to where patients live is crucial to a faster scale up, however, a key obstacle is limited health system capacity due to a shortage of trained health-care workers and challenges of integrating HIV/AIDS care with other primary care services (e.g. tuberculosis, malaria, respiratory conditions). This study will test an adapted primary care health care worker training and guideline intervention, Practical Approach to Lung Health and HIV/AIDS Malawi (PALM PLUS), on staff retention and satisfaction, and quality of patient care. A cluster-randomized trial design is being used to compare usual care with a standardized clinical guideline and training intervention, PALM PLUS. The intervention targets middle-cadre health care workers (nurses, clinical officers, medical assistants) in 30 rural primary care health centres in a single district in Malawi. PALM PLUS is an integrated, symptom-based and user-friendly guideline consistent with Malawian national treatment protocols. Training is standardized and based on an educational outreach approach. Trainers will be front-line peer healthcare workers trained to provide outreach training and support to their fellow front-line healthcare workers during focused (1-2 hours), intermittent, interactive sessions on-site in health centers. Primary outcomes are health care worker retention and satisfaction. Secondary outcomes are clinical outcomes measured at the health centre level for HIV/AIDS, tuberculosis, prevention-of-mother-to-child-transmission of HIV and other primary care conditions. Effect sizes and 95% confidence intervals for outcomes will be presented. Assessment of outcomes will occur at 1 year post- implementation. The PALM PLUS trial aims to address a key problem: strengthening middle

  13. Use of outcome measures in pulmonary hypertension clinical trials.

    PubMed

    Parikh, Kishan S; Rajagopal, Sudarshan; Arges, Kristine; Ahmad, Tariq; Sivak, Joseph; Kaul, Prashant; Shah, Svati H; Tapson, Victor; Velazquez, Eric J; Douglas, Pamela S; Samad, Zainab

    2015-09-01

    To evaluate the use of surrogate measures in pulmonary hypertension (PH) clinical trials and how it relates to clinical practice. Studies of pulmonary arterial hypertension (PAH) employ a variety of surrogate measures in addition to clinical events because of a small patient population, participant burden, and costs. The use of these measures in PH drug trials is poorly defined. We searched PubMed/MEDLINE/Embase for randomized or prospective cohort PAH clinical treatment trials from 1985 to 2013. Extracted data included intervention, trial duration, study design, patient characteristics, and primary and secondary outcome measures. To compare with clinical practice, we assessed the use of surrogate measures in a clinical sample of patients on PH medications at Duke University Medical Center between 2003 and 2014. Between 1985 and 2013, 126 PAH trials were identified and analyzed. Surrogate measures served as primary endpoints in 119 trials (94.0%). Inclusion of invasive hemodynamics decreased over time (78.6%, 75.0%, 52.2%; P for trend = .02), while functional testing (7.1%, 60.0%, 81.5%; P for trend < .0001) and functional status or quality of life (0%, 47.6%, 62.8%; P for trend < .0001) increased in PAH trials over the same time periods. Echocardiography data were reported as a primary or secondary outcome in 32 trials (25.4%) with increased use from 1985-1994 to 1995-2004 (7.1% vs 35.0%, P = .04), but the trend did not continue to 2005-2013 (25.0%). In comparison, among 450 patients on PAH therapies at our institution between 2003 and 2013, clinical assessments regularly incorporated serial echocardiography and 6-minute walk distance tests (92% and 95% of patients, respectively) and repeat measurement of invasive hemodynamics (46% of patients). The majority of PAH trials have utilized surrogate measures as primary endpoints. The use of these surrogate endpoints has evolved significantly over time with increasing use of patient-centered endpoints and decreasing or

  14. Klebsiella pneumoniae Infection Leads to a Poor Visual Outcome in Endogenous Endophthalmitis: A 12-year Experience in Southern Taiwan.

    PubMed

    Chen, Shih-Chou; Lee, Ying-Yen; Chen, Ya-Hsin; Lin, Huey-Shyan; Wu, Tsung-Tien; Sheu, Shwu-Jiuan

    2017-12-01

    To compare the characteristics, visual outcome, and prognostic factors of patients with endogenous endophthalmitis and to determine the association of endophthalmitis with Klebsiella pneumoniae infection. We retrospectively analyzed records of patients diagnosed with endogenous endophthalmitis from January 2002 to August 2013. A total of 86 patients were diagnosed with endogenous endophthalmitis; 48 patients were infected with K. pneumoniae, 28 patients were infected with other pathogens, and 10 were culture-negative. Diabetes mellitus was more prevalent among patients infected with K. pneumoniae. Liver abscess and urinary tract infection were the leading sources of infection in patients with and without a K. pneumoniae infection, respectively. In patients with endogenous endophthalmitis, poor initial vision (p<0.001) and K. pneumoniae infection (p = 0.048) were significantly associated with a poor visual outcome. Poor initial vision and K. pneumoniae infection were significantly associated with poorer visual outcome for patients with endogenous endophthalmitis.

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

    PubMed

    Choi, Wook Jin; Kim, Jeongseon

    2016-04-01

    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 complications (e.g., wound/infectious complications) compared to well-nourished patients. Malnutrition is commonly found in advanced gastric cancer patients due to poor absorption of essential nutrients after surgery. Therefore, nutritional support protocols, such as early oral and enternal feeding, have been proposed in many studies, to improve unfavorable clinical outcomes and to reduce complications due to delayed application of oral nutritional support or parental feeding. Also, the supplied with enternal immune-enriched diet had more benefits in improving clinical outcomes and fewer complications compared to a group supplied with control formula. Using nutritional screening tools, such as nutritional risk index (NRI) and nutritional risk screening (NRS 2002), malnourished patients showed higher incidence of complications and lower survival rates than non-malnourished patients. However, a long-term nutritional intervention, such as nutritional counseling, was not effective in the patients. Therefore, early assessment of nutritional status in patients using a proper nutritional screening tool is suggested to prevent malnutrition and adverse health outcomes. Further studies with numerous ethnic groups may provide stronger scientific evidences in association between nutritional care and recovery from surgery in patients with gastric cancer.

  16. Treatment outcomes of HIV-positive patients on first-line antiretroviral therapy in private versus public HIV clinics in Johannesburg, South Africa.

    PubMed

    Moyo, Faith; Chasela, Charles; Brennan, Alana T; Ebrahim, Osman; Sanne, Ian M; Long, Lawrence; Evans, Denise

    2016-01-01

    Despite the widely documented success of antiretroviral therapy (ART), stakeholders continue to face the challenges of poor HIV treatment outcomes. While many studies have investigated patient-level causes of poor treatment outcomes, data on the effect of health systems on ART outcomes are scarce. We compare treatment outcomes among patients receiving HIV care and treatment at a public and private HIV clinic in Johannesburg, South Africa. This was a retrospective cohort analysis of ART naïve adults (≥18.0 years), initiating ART at a public or private clinic in Johannesburg between July 01, 2007 and December 31, 2012. Cox proportional-hazards regression was used to identify baseline predictors of mortality and loss to follow-up (>3 months late for the last scheduled visit). Generalized estimating equations were used to determine predictors of failure to suppress viral load (≥400 copies/mL) while the Wilcoxon rank-sum test was used to compare the median absolute change in CD4 count from baseline to 12 months post-ART initiation. 12,865 patients initiated ART at the public clinic compared to 610 at the private clinic. The patients were similar in terms of sex and age at initiation. Compared to public clinic patients, private clinic patients initiated ART at higher median CD4 counts (159 vs 113 cells/mm(3)) and World Health Organization stage I/II (76.1% vs 58.5%). Adjusted hazard models showed that compared to public clinic patients, private clinic patients were less likely to die (adjusted hazard ratio [aHR] 0.50; 95% confidence interval [CI] 0.35-0.70) but were at increased risk of loss to follow-up (aHR 1.80; 95% CI 1.59-2.03). By 12 months post-ART initiation, private clinic patients were less likely to have a detectable viral load (adjusted relative risk 0.65; 95% CI 0.49-0.88) and recorded higher median CD4 change from baseline (184 cells/mm(3) interquartile range 101-300 vs 158 cells/mm(3) interquartile range 91-244), when compared to public clinic

  17. Relationship between the duration of trimethoprim/sulfamethoxazole treatment and the clinical outcome of pulmonary nocardiosis.

    PubMed

    Tashiro, Hiroki; Takahashi, Koichiro; Kusaba, Koji; Tanaka, Masahide; Komiya, Kazutoshi; Nakamura, Tomomi; Aoki, Yosuke; Kimura, Shinya; Sueoka-Aragane, Naoko

    2018-03-01

    Despite treatment, pulmonary nocardiosis, which is a rare opportunistic disease caused by Nocardia species, has poor clinical outcomes including recurrence and death. Currently, the treatment regimen and duration for pulmonary nocardiosis are not fully understood. The present study aimed to clarify the factors related to the clinical outcome of pulmonary nocardiosis. The medical records of 24 patients with pulmonary nocardiosis were retrospectively reviewed. The patients were divided into two groups based on the outcomes within 2 years: patients with controlled disease (n = 14) and patients who developed recurrence or died (n = 10). Nocardia was identified by 16S ribosomal RNA sequencing in 17 patients (70.8%) and by conventional biochemical test in five patients (20.8%). The patients' characteristics, clinical findings, radiological features, and treatment history were not different between the two groups. Compared with patients who developed recurrence or died, those with controlled disease had significantly longer total duration of treatment with antibiotics, especially trimethoprim/sulfamethoxazole (67.5 ± 111.6 days vs. 9.0 ± 6.5 days; p = 0.01). Pancytopenia was the most frequent adverse effect of trimethoprim/sulfamethoxazole. Longer duration of trimethoprim/sulfamethoxazole treatment was significantly associated with better outcomes of pulmonary nocardiosis. In such cases, antibiotics, especially trimethoprim/sulfamethoxazole, should be administered for more than 3 months. Copyright © 2017 The Japanese Respiratory Society. Published by Elsevier B.V. All rights reserved.

  18. Risk for poor outcomes in older patients discharged from an emergency department: feasibility of four screening instruments.

    PubMed

    Buurman, Bianca M; van den Berg, Wendy; Korevaar, Johanna C; Milisen, Koen; de Haan, Rob J; de Rooij, Sophia E

    2011-08-01

    To compare the prognostic value of four screening instruments used to detect the risk for poor outcomes [in terms of likelihood of recurrent emergency department (ED) visits, hospitalizations, or mortality] for older patients discharged home from an ED in the Netherlands. This is a prospective cohort study, which included all consecutive patients of at least 65 years discharged from the ED of a university teaching hospital in the Netherlands, between 1 December 2005, and 1 November 2006. Four screening instruments were tested: the identification of seniors at risk, the triage risk screening tool, and the Runciman and Rowland questionnaires. The cutoff of the Runciman questionnaire was adapted and the age cutoff was adapted for the other instruments. Recurrent ED visits, subsequent hospitalization, and mortality within 30 and 120 days after the index visit were collected from administrative data. In total, 381 patients were included, with a mean age of 79.1 years. Within 120 days, 14.7% of the patients returned to ED, 17.2% were hospitalized, and 2.9% died. The area under the curve was low for all instruments (between 0.43 and 0.60), indicating poor discriminatory power. Older ED patients discharged home are at higher risk of poor outcomes. None of the instruments were able to clearly discriminate between patients with and without poor outcomes. Differences in organization of the health care systems might influence the prognostic abilities of screening instruments.

  19. Pontin Acts as a Potential Biomarker for Poor Clinical Outcome and Promotes Tumor Invasion in Hilar Cholangiocarcinoma.

    PubMed

    Sun, Qi; Li, Fanni; Yu, Songyang; Zhang, Xiang; Shi, Feiyu; She, Junjun

    2018-01-01

    Hilar cholangiocarcinoma (HC) is a devastating malignancy that carries a poor overall prognosis. As a member of the AAA+ superfamily, Pontin becomes highly expressed in several malignant tumors, which contributes to tumor progression and influences tumor prognosis. In our research, Pontin expression in tumor specimens resected from 86 HC patients was detected by immunohistochemistry. Interestingly, high expression of Pontin was significantly associated with lymph node metastasis ( p = 0.011) and tumor node metastasis (TNM) stage ( p = 0.005). The Kaplan-Meier overall survival rate and multivariate analyses were performed to evaluate the prognosis of patients with HC. Patients with high Pontin expression had significantly poorer overall survival outcomes. Multivariate analyses found that Pontin was an independent prognostic factor ( p = 0.001). Moreover, bioinformatics analysis confirmed the increase in Pontin mRNA expression levels in cholangiocarcinoma tissues. In addition, in vitro experiments showed that Pontin expression was inhibited at the mRNA as well as protein levels after transfection with Pontin siRNA in human cholangiocarcinoma cell lines. Moreover, significant suppression of cell invasion was observed after the downregulation of Pontin. Taken together, the present study suggested that Pontin could act as a potential prognostic predictor, which might be a new valuable molecular candidate for the prevention and treatment of HC.

  20. Improved glycemic control in veterans with poorly controlled diabetes mellitus using a Specialty Care Access Network-Extension for Community Healthcare Outcomes model at primary care clinics.

    PubMed

    Watts, Sharon A; Roush, Laura; Julius, Mary; Sood, Ajay

    2016-06-01

    An increasing number of patients with diabetes mellitus has created a need for innovative delivery of specialized care not only by diabetes specialists but also by primary care providers (PCPs) as well. A potential avenue to address this need is training of PCPs by specialists via telehealth. The Veteran Affairs (VA) Specialty Care Access Network-Extension for Community Healthcare Outcomes (SCAN-ECHO) program includes education and case-based learning for PCPs by a multidisciplinary specialty team utilizing videoconferencing technology. Two PCPs completed a year of SCAN-ECHO diabetes training. These two PCPs set up "diabetes mini-clinics" to treat difficult-to-control high-risk patients with diabetes mellitus from their own panel and from their colleagues in the same community-based outpatient clinic (CBOC). We utilized a retrospective program evaluation by t-test using pre/post glycated hemoglobin (HbA1c) lab values after being seen by the two PCPs. A total of 39 patients, all with HbA1c > 9.0%, were seen in the two PCP mini-clinics over 15 months. The mean HbA1c improved from 10.2 ± 1.4% to 8.4 ± 1.8% (p < 0.001) over the average follow-up period of five months. This was not explained by system-wide changes or improvements. Care of veteran patients with poorly controlled diabetes by PCPs who participated in SCAN-ECHO program leads to improvement in glycemic control. This model of health care delivery can be effective in remote or rural areas with limited availability of specialists. © The Author(s) 2015.

  1. Brainstem encephalitis: etiologies, treatment, and predictors of outcome

    PubMed Central

    Tan, Ik Lin; Mowry, Ellen M.; Steele, Sonya U.; Pardo, Carlos A.; McArthur, Justin C.; Nath, Avindra

    2016-01-01

    Brainstem encephalitis (BE) is an uncommon condition. We sought to characterize clinical presentations, etiologies, response to treatment, and predictors of outcome. We performed a retrospective review of non–HIV infected patients diagnosed with BE at Johns Hopkins Hospital (January 1997–April 2010). We characterized clinical and paraclinical features, and used regression models to assess associations with poor outcome. BE was diagnosed in 81 patients. An etiology was identified in 58 of 81 (71.6 %) of cases, most of which were confirmed or probable inflammatory/autoimmune conditions. Of the remaining 23 cases in which a specific diagnosis remained undefined, clinical presentation, CSF, neuroimaging studies, and outcomes were similar to the inflammatory/autoimmune group. Brain biopsy identified a specific diagnosis in 7 of 14 patients (50 %). Fifteen patients (18.5 %) either died or had a poor outcome. In multivariate logistic regression models, a higher CSF protein (per 5 mg/dl, OR = 1.11, 95 % CI: 1.03–1.20), a higher CSF glucose (per 5 mg/dl, OR = 1.36, 95 % CI: 1.09–1.70), and higher serum glucose (per 5 mg/dl, OR = 1.27, 95 % CI: 1.06–1.52) were independently associated with increased odds of poor outcome. Inflammatory and non-infectious conditions accounted for most cases of BE. Higher CSF protein and glucose were independently associated with poor outcome. In immunocompetent patients with BE of undefined etiology despite extensive investigation, a trial of immunosuppressive treatment may be warranted, though deterioration clinically or on magnetic resonance imaging should prompt a brain biopsy. PMID:23749332

  2. Age at onset versus family history and clinical outcomes in 1,665 international bipolar-I disorder patients

    PubMed Central

    BALDESSARINI, ROSS J.; TONDO, LEONARDO; VAZQUEZ, GUSTAVO H.; UNDURRAGA, JUAN; BOLZANI, LORENZA; YILDIZ, AYSEGUL; KHALSA, HARI-MANDIR K.; LAI, MASSIMO; LEPRI, BEATRICE; LOLICH, MARIA; MAFFEI, PIER MARIO; SALVATORE, PAOLA; FAEDDA, GIANNI L.; VIETA, EDUARD; MAURICIO, TOHEN

    2012-01-01

    Early onset in bipolar disorder (BPD) has been associated with greater familial risk and unfavorable clinical outcomes. We pooled data from seven international centers to analyze the relationships of family history and symptomatic as well as functional measures of adult morbidity to onset age, or onset in childhood (age <12), adolescence (12-18), or adulthood (19-55 years). In 1,665 adult, DSM-IV BPD-I patients, onset was 5% in childhood, 28% in adolescence, and 53% at peak ages 15-25. Adolescent and adult onset did not differ by symptomatic morbidity (episodes/year, percentage of months ill, co-morbidity, hospitalization, suicide attempts) or family history. Indications of favorable adult functional outcomes (employment, living independently, marriage and children, and a composite measure including education) ranked, by onset: adult > adolescent > child. Onset in childhood versus adolescence had more episodes/year and more psychiatric co-morbidity. Family history was most prevalent with childhood onset, similar over onset ages 12-40 years, and fell sharply thereafter. Multivariate modeling sustained the impression that family history and poor functional, but not symptomatic, outcomes were associated with younger, especially childhood onset. Early onset was more related to poor functional outcomes than greater symptomatic morbidity, with least favorable outcomes and greater family history with childhood onset. PMID:22295008

  3. Immediate coma and poor outcome in subarachnoid haemorrhage are independently associated with an aneurysmal origin.

    PubMed

    Tsermoulas, Georgios; Flett, Lisa; Gregson, Barbara; Mitchell, Patrick

    2013-08-01

    Subarachnoid haemorrhage (SAH) may present with coma and this is known to be associated with aneurysmal origin and blood load. Aneurysmal origin is associated with increased blood load and existing data do not allow us to determine if the association between coma and aneurysmal SAH is wholly due to blood load or if aneurysmal origin has an additional independent effect. The objective of our study is to find if an aneurysmal origin is a predictor of acute onset of coma independent of blood load. A series of consecutive patients with spontaneous SAH were divided into two groups: aneurysmal (aSAH) and non-aneurysmal--angiographically negative SAH (naSAH). Blood load was quantified so that the effect of aneurysmal origin could be resolved from the effect of the amount of blood spilled. Non-parametric regression was used to relate blood load to coma and poor outcome rates for aneurysmal bleeds. We analysed a total of 421 patients presenting during the period 2009-2011. Ninety aneurysmal cases presented with coma, seventy immediately in the early phase and seven shortly after rebleeding. None of the naSAH cases presented with immediate coma and 1 developed delayed coma. Delayed coma was associated with acute hydrocephalus in both groups. Aneurysmal origin was found to be an independent determinant of immediate coma (p=0.02) and poor outcome (p<0.001). Immediate coma and poor outcome in SAH are associated with an aneurysmal origin and do not characterize naSAH. Copyright © 2013 Elsevier B.V. All rights reserved.

  4. Germline BRCA Mutations Are Associated With Higher Risk of Nodal Involvement, Distant Metastasis, and Poor Survival Outcomes in Prostate Cancer

    PubMed Central

    Castro, Elena; Goh, Chee; Olmos, David; Saunders, Ed; Leongamornlert, Daniel; Tymrakiewicz, Malgorzata; Mahmud, Nadiya; Dadaev, Tokhir; Govindasami, Koveela; Guy, Michelle; Sawyer, Emma; Wilkinson, Rosemary; Ardern-Jones, Audrey; Ellis, Steve; Frost, Debra; Peock, Susan; Evans, D. Gareth; Tischkowitz, Marc; Cole, Trevor; Davidson, Rosemarie; Eccles, Diana; Brewer, Carole; Douglas, Fiona; Porteous, Mary E.; Donaldson, Alan; Dorkins, Huw; Izatt, Louise; Cook, Jackie; Hodgson, Shirley; Kennedy, M. John; Side, Lucy E.; Eason, Jacqueline; Murray, Alex; Antoniou, Antonis C.; Easton, Douglas F.; Kote-Jarai, Zsofia; Eeles, Rosalind

    2013-01-01

    Purpose To analyze the baseline clinicopathologic characteristics of prostate tumors with germline BRCA1 and BRCA2 (BRCA1/2) mutations and the prognostic value of those mutations on prostate cancer (PCa) outcomes. Patients and Methods This study analyzed the tumor features and outcomes of 2,019 patients with PCa (18 BRCA1 carriers, 61 BRCA2 carriers, and 1,940 noncarriers). The Kaplan-Meier method and Cox regression analysis were used to evaluate the associations between BRCA1/2 status and other PCa prognostic factors with overall survival (OS), cause-specific OS (CSS), CSS in localized PCa (CSS_M0), metastasis-free survival (MFS), and CSS from metastasis (CSS_M1). Results PCa with germline BRCA1/2 mutations were more frequently associated with Gleason ≥ 8 (P = .00003), T3/T4 stage (P = .003), nodal involvement (P = .00005), and metastases at diagnosis (P = .005) than PCa in noncarriers. CSS was significantly longer in noncarriers than in carriers (15.7 v 8.6 years, multivariable analyses [MVA] P = .015; hazard ratio [HR] = 1.8). For localized PCa, 5-year CSS and MFS were significantly higher in noncarriers (96% v 82%; MVA P = .01; HR = 2.6%; and 93% v 77%; MVA P = .009; HR = 2.7, respectively). Subgroup analyses confirmed the poor outcomes in BRCA2 patients, whereas the role of BRCA1 was not well defined due to the limited size and follow-up in this subgroup. Conclusion Our results confirm that BRCA1/2 mutations confer a more aggressive PCa phenotype with a higher probability of nodal involvement and distant metastasis. BRCA mutations are associated with poor survival outcomes and this should be considered for tailoring clinical management of these patients. PMID:23569316

  5. Conventional MRI features for predicting the clinical outcome of patients with invasive placenta

    PubMed Central

    Chen, Ting; Xu, Xiao-Quan; Shi, Hai-Bin; Yang, Zheng-Qiang; Zhou, Xin; Pan, Yi

    2017-01-01

    PURPOSE We aimed to evaluate whether morphologic magnetic resonance imaging (MRI) features could help to predict the maternal outcome after uterine artery embolization (UAE)-assisted cesarean section (CS) in patients with invasive placenta previa. METHODS We retrospectively reviewed the MRI data of 40 pregnant women who have undergone UAE-assisted cesarean section due to suspected high risk of massive hemorrhage caused by invasive placenta previa. Patients were divided into two groups based on the maternal outcome (good-outcome group: minor hemorrhage and uterus preserved; poor-outcome group: significant hemorrhage or emergency hysterectomy). Morphologic MRI features were compared between the two groups. Multivariate logistic regression analysis was used to identify the most valuable variables, and predictive value of the identified risk factor was determined. RESULTS Low signal intensity bands on T2-weighted imaging (P < 0.001), placenta percreta (P = 0.011), and placental cervical protrusion sign (P = 0.002) were more frequently observed in patients with poor outcome. Low signal intensity bands on T2-weighted imaging was the only significant predictor of poor maternal outcome in multivariate analysis (P = 0.020; odds ratio, 14.79), with 81.3% sensitivity and 84.3% specificity. CONCLUSION Low signal intensity bands on T2-weighted imaging might be a predictor of poor maternal outcome after UAE-assisted cesarean section in patients with invasive placenta previa. PMID:28345524

  6. Perioperative factors predicting poor outcome in elderly patients following emergency general surgery: a multivariate regression analysis

    PubMed Central

    Lees, Mackenzie C.; Merani, Shaheed; Tauh, Keerit; Khadaroo, Rachel G.

    2015-01-01

    Background Older adults (≥ 65 yr) are the fastest growing population and are presenting in increasing numbers for acute surgical care. Emergency surgery is frequently life threatening for older patients. Our objective was to identify predictors of mortality and poor outcome among elderly patients undergoing emergency general surgery. Methods We conducted a retrospective cohort study of patients aged 65–80 years undergoing emergency general surgery between 2009 and 2010 at a tertiary care centre. Demographics, comorbidities, in-hospital complications, mortality and disposition characteristics of patients were collected. Logistic regression analysis was used to identify covariate-adjusted predictors of in-hospital mortality and discharge of patients home. Results Our analysis included 257 patients with a mean age of 72 years; 52% were men. In-hospital mortality was 12%. Mortality was associated with patients who had higher American Society of Anesthesiologists (ASA) class (odds ratio [OR] 3.85, 95% confidence interval [CI] 1.43–10.33, p = 0.008) and in-hospital complications (OR 1.93, 95% CI 1.32–2.83, p = 0.001). Nearly two-thirds of patients discharged home were younger (OR 0.92, 95% CI 0.85–0.99, p = 0.036), had lower ASA class (OR 0.45, 95% CI 0.27–0.74, p = 0.002) and fewer in-hospital complications (OR 0.69, 95% CI 0.53–0.90, p = 0.007). Conclusion American Society of Anesthesiologists class and in-hospital complications are perioperative predictors of mortality and disposition in the older surgical population. Understanding the predictors of poor outcome and the importance of preventing in-hospital complications in older patients will have important clinical utility in terms of preoperative counselling, improving health care and discharging patients home. PMID:26204143

  7. Influence of preoperative nutritional status on clinical outcomes after pancreatoduodenectomy.

    PubMed

    Kim, Eunjung; Kang, Jae Seung; Han, Youngmin; Kim, Hongbeom; Kwon, Wooil; Kim, Jae Ri; Kim, Sun-Whe; Jang, Jin-Young

    2018-06-07

    This study investigated the clinical outcomes according to the preoperative nutritional status and to identify factors influencing long-term unrecovered nutritional status. Data were prospectively collected from 355 patients who underwent PD between 2008 and 2014. Nutritional status was evaluated by Mini Nutrition Assessment (MNA) and patients were classified into group A (malnourished), group B (risk-of-malnutrition), or group C (well-nourished). MNA score, complications, body mass index (BMI), stool elastase level, biochemical parameters, and quality-of-life (QOL) were collected serially for 1 year. Preoperatively, 60 patients were categorized into group A, 224 into group B, and 71 into group C. Overall complication and pancreatic fistula were higher in groups A and B compared with group C (P = 0.003 vs P = 0.004). QOL, biochemical parameters, BMI and stool elastase level were lowest in group A preoperatively. BMI and stool elastase level remained low after surgery in all groups. Advanced age, low BMI, pre-existing diabetes mellitus, jaundice, exocrine insufficiency and adjuvant therapy were factors influencing long-term unrecovered nutritional status. Preoperative malnourished patients suffer from poor clinical outcomes. Therefore, those with risk factors of malnutrition should be monitored and vigorous efforts are needed to improve their nutrition. Copyright © 2018 International Hepato-Pancreato-Biliary Association Inc. Published by Elsevier Ltd. All rights reserved.

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

    PubMed

    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.

  9. Behavioral and cognitive outcomes for clinical trials in children with neurofibromatosis type 1.

    PubMed

    van der Vaart, Thijs; Rietman, André B; Plasschaert, Ellen; Legius, Eric; Elgersma, Ype; Moll, Henriëtte A

    2016-01-12

    To evaluate the appropriateness of cognitive and behavioral outcome measures in clinical trials in neurofibromatosis type 1 (NF1) by analyzing the degree of deficits compared to reference groups, test-retest reliability, and how scores correlate between outcome measures. Data were analyzed from the Simvastatin for cognitive deficits and behavioral problems in patients with neurofibromatosis type 1 (NF1-SIMCODA) trial, a randomized placebo-controlled trial of simvastatin for cognitive deficits and behavioral problems in children with NF1. Outcome measures were compared with age-specific reference groups to identify domains of dysfunction. Pearson r was computed for before and after measurements within the placebo group to assess test-retest reliability. Principal component analysis was used to identify the internal structure in the outcome data. Strongest mean score deviations from the reference groups were observed for full-scale intelligence (-1.1 SD), Rey Complex Figure Test delayed recall (-2.0 SD), attention problems (-1.2 SD), and social problems (-1.1 SD). Long-term test-retest reliability were excellent for Wechsler scales (r > 0.88), but poor to moderate for other neuropsychological tests (r range 0.52-0.81) and Child Behavioral Checklist subscales (r range 0.40-0.79). The correlation structure revealed 2 strong components in the outcome measures behavior and cognition, with no correlation between these components. Scores on psychosocial quality of life correlate strongly with behavioral problems and less with cognitive deficits. Children with NF1 show distinct deficits in multiple domains. Many outcome measures showed weak test-retest correlations over the 1-year trial period. Cognitive and behavioral outcomes are complementary. This analysis demonstrates the need to include reliable outcome measures on a variety of cognitive and behavioral domains in clinical trials for NF1. © 2015 American Academy of Neurology.

  10. Clinical Outcome Score Predicts Adverse Neurodevelopmental Outcome After Infant Heart Surgery.

    PubMed

    Mackie, Andrew S; Vatanpour, Shabnam; Alton, Gwen Y; Dinu, Irina A; Ryerson, Lindsay; Moddemann, Diane M; Thomas Petrie, Julie

    2015-06-01

    The purpose of this study was to determine whether a clinical outcome score derived from early postoperative events is associated with Bayley-III scores at 18 to 24 months among infants undergoing cardiopulmonary bypass surgery. Included were infants aged 6 weeks or less who underwent surgery between 2005 and 2009, all of whom were referred for neurodevelopmental evaluation at 18 to 24 months. We excluded children with chromosomal abnormalities. The prespecified clinical outcome score had a range of 0 to 7. Lower scores indicated a more rapid postoperative recovery. Patients requiring extracorporeal life support were assigned a score of 7. One hundred and ninety-nine subjects were included. Surgical procedures were arterial switch (72), Norwood (60), repair of total anomalous pulmonary venous connection (29), and other (38). Nine subjects had postoperative extracorporeal life support. Mean clinical outcome score in the Norwood group was 4.0 ± 1.4 versus the arterial switch group (2.6 ± 1.5, p < 0.001), total anomalous pulmonary venous connection group (2.8 ± 1.8, p < 0.01), and other group (4.0 ± 1.8, p = not significant). Among children who had a clinical outcome score of 4 or greater, there was a decrease in Bayley-III cognitive score of 5.7 (95% confidence interval: 1.5 to 9.9, p = 0.009), a decrease in language score of 10.0 (95% confidence interval: 4.9 to 15.1, p < 0.001), and a decrease in motor score of 9.7 (95% confidence interval: 4.8 to 14.5, p < 0.001). Time until lactate of 2.0 mmol/L or less and highest 24-hour inotrope score increased with increasing clinical outcome score (p < 0.0001). Clinical outcome scores of 4 or greater were associated with significantly lower Bayley-III scores at 18 to 24 months. This score may be valuable as an endpoint when evaluating novel potential therapies for this high-risk population. Copyright © 2015 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.

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

    PubMed

    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.

  12. Poor outcome of oesophageal adenocarcinoma after prior antireflux surgery.

    PubMed

    Mitchell, E M; Pal, N; Kalyan, J P; Rhodes, M; Lewis, M P N

    2009-12-01

    Gastro-oesophageal reflux disease is an important risk factor for oesophageal adenocarcinoma, but abolishing reflux through surgery has not been shown to reduce this risk. The purpose of this study is to report on adenocarcinomas occurring after previous antireflux surgery and their long-term outcome. Six hundred and forty three patients underwent surgical resection in our unit for oesophagogastric adenocarcinoma between 2000 and 2009. Nine of these had antireflux surgery a median of 6.9 (mean of 9.3) years previously. Clinical and pathological characteristics and outcome (in terms of survival) are described for this patient group. The patients who had prior antireflux surgery were compared to matched control patients for disease free survival. Disease free survival in our antireflux patients was 25.1% as compared to 72.1% in controls at 3 years. (Log rank test p=0.004). Patients who have undergone antireflux surgery for chronic gastro-oesophageal reflux disease can develop adenocarcinoma and need to be monitored closely. The outcome following surgery appears greatly worse for patients with previous antireflux surgery than age/sex/stage/treatment matched controls in this small study.

  13. A Propensity Score Analysis of the Impact of Dexamethasone Use on Delayed Cerebral Ischemia and Poor Functional Outcomes After Subarachnoid Hemorrhage.

    PubMed

    Mohney, Nathaniel; Williamson, Craig A; Rothman, Edward; Ball, Ron; Sheehan, Kyle M; Pandey, Aditya S; Fletcher, Jeffrey J; Jacobs, Teresa L; Thompson, B Gregory; Rajajee, Venkatakrishna

    2018-01-01

    An inflammatory response occurs after aneurysmal subarachnoid hemorrhage (aSAH) and predicts poor outcomes. Glucocorticoids suppress inflammation and promote fluid retention. Dexamethasone is often administered after aSAH for postoperative cerebral edema and refractory headache. Our objective was to examine the impact of dexamethasone use on functional outcomes and delayed cerebral ischemia (DCI) after aSAH. Patients with aSAH admitted between 2010 and 2015 were included; the data source was a single-center subarachnoid hemorrhage registry. The intervention of interest was a dexamethasone taper used <7 days from ictus. The primary outcome was poor discharge functional outcome, with a modified Rankin Scale score >3. Other outcomes included DCI and infection. A propensity score for use of dexamethasone was calculated using a logistic regression model that included potential predictors of dexamethasone use and outcome. The impact of dexamethasone on outcomes of interest was calculated and the propensity score was controlled for. A total of 440 patients with subarachnoid hemorrhage were admitted during the study period and 309 met eligibility criteria. Dexamethasone was administered in 101 patients (33%). A total of 127 patients (41%) had a discharge modified Rankin Scale score >3, 105 (34%) developed DCI, and 94 (30%) developed an infection. After propensity score analysis, dexamethasone use was associated with a significant reduction in poor functional outcomes (odds ratio [OR], 0.35; 95% confidence interval [CI], 0.19-0.66) but showed no significant association with DCI (OR, 0.93; 95% CI, 0.53-1.64) or infection (OR, 0.60; 95% CI, 0.34-1.06). Dexamethasone use after aSAH was associated with a reduction in poor functional outcomes at discharge but not DCI, controlling for predictors of dexamethasone use. Copyright © 2017 Elsevier Inc. All rights reserved.

  14. Perinatal brain injury, visual motor function and poor school outcome of regional low birth weight survivors at age nine.

    PubMed

    Zhang, Jun; Mahoney, Ashley Darcy; Pinto-Martin, Jennifer A

    2013-08-01

    To explore the relationship between perinatal brain injury, visual motor function (VMF) and poor school outcome. Little is known about the status and underlying mechanism of poor school outcome as experienced by low birth weight survivors. This is a secondary data analysis. The parental study recruited 1104 low birth weight (LBW) infants weighing ≤ 2000 g from three medical centres of Central New Jersey between 1984 and 1987. Seven hundred and seventy-seven infants survived the neonatal period, and their developmental outcomes had been following up regularly until now. The development data of the survivors were used to achieve the research aims. Initial school outcome assessment was carried out in 9-year-old, using the Woodcock-Johnson Academic Achievement Scale. The severity and range of perinatal brain injury was determined by repeated neonatal cranial ultrasound results obtained at 4 hours, 24 hours and 7 days of life. Seventeen and a half per cent of the sample experienced poor school performance at age 9 as defined by lower than one standard deviation (SD) of average performance score. Children with the most severe injury, PL/VE, had the lowest mathematics (F = 14·54, p = 0·000) and reading (anova results: F = 11·56, p = 0·000) performances. Visual motor function had a significant effect on children's overall school performance (Hotelling's trace value was 0·028, F = 3·414, p = 0·018), as well as subtest scores for reading (p = 0·006) and mathematics (p = 0·036). However, visual motor function was not a mediator in the association of perinatal brain injury and school outcome. Perinatal brain injury had a significant long-term effect on school outcome. Low birth weight infants with history of perinatal brain injury need be closely monitored to substantially reduce the rates of poor school outcome and other neurodevelopmental disabilities. © 2012 Blackwell Publishing Ltd.

  15. Preimplantation genetic screening for all 24 chromosomes by microarray comparative genomic hybridization significantly increases implantation rates and clinical pregnancy rates in patients undergoing in vitro fertilization with poor prognosis

    PubMed Central

    Majumdar, Gaurav; Majumdar, Abha; Lall, Meena; Verma, Ishwar C.; Upadhyaya, Kailash C.

    2016-01-01

    CONTEXT: A majority of human embryos produced in vitro are aneuploid, especially in couples undergoing in vitro fertilization (IVF) with poor prognosis. Preimplantation genetic screening (PGS) for all 24 chromosomes has the potential to select the most euploid embryos for transfer in such cases. AIM: To study the efficacy of PGS for all 24 chromosomes by microarray comparative genomic hybridization (array CGH) in Indian couples undergoing IVF cycles with poor prognosis. SETTINGS AND DESIGN: A retrospective, case–control study was undertaken in an institution-based tertiary care IVF center to compare the clinical outcomes of twenty patients, who underwent 21 PGS cycles with poor prognosis, with 128 non-PGS patients in the control group, with the same inclusion criterion as for the PGS group. MATERIALS AND METHODS: Single cells were obtained by laser-assisted embryo biopsy from day 3 embryos and subsequently analyzed by array CGH for all 24 chromosomes. Once the array CGH results were available on the morning of day 5, only chromosomally normal embryos that had progressed to blastocyst stage were transferred. RESULTS: The implantation rate and clinical pregnancy rate (PR) per transfer were found to be significantly higher in the PGS group than in the control group (63.2% vs. 26.2%, P = 0.001 and 73.3% vs. 36.7%, P = 0.006, respectively), while the multiple PRs sharply declined from 31.9% to 9.1% in the PGS group. CONCLUSIONS: In this pilot study, we have shown that PGS by array CGH can improve the clinical outcome in patients undergoing IVF with poor prognosis. PMID:27382234

  16. Low appendicular skeletal muscle mass (ASM) with limited mobility and poor health outcomes in middle-aged African Americans.

    PubMed

    Malmstrom, Theodore K; Miller, Douglas K; Herning, Margaret M; Morley, John E

    2013-09-01

    Recent efforts to provide a consensus definition propose that sarcopenia be considered a clinical syndrome associated with the loss of both skeletal muscle mass and muscle function that occurs with aging. Validation of sarcopenia definitions that include both low muscle mass and poor muscle function is needed. In the population-based African American Health (AAH) study (N = 998 at baseline/wave 1), muscle mass and mobility were evaluated in a clinical testing center in a subsample of N = 319 persons (ages 52-68) at wave 4 (2004). Muscle mass was measured using dual energy x-ray absorptiometry and mobility by a 6-min walk test and 4-m gait walk test. Height corrected appendicular skeletal mass (ASM; 9.0 ± 1.5 in n = 124 males, 8.3 ± 2.2 in n = 195 females) was computed as total lean muscle mass in arms and legs (kilograms) divided by the square of height (meters). Cross-sectional and longitudinal (6-year) associations of low ASM (bottom 25 % AAH sample; <7.96 males and <7.06 females) and low ASM with limited mobility (4-m gait walk ≤1 m/s or 6-min walk <400 m) were examined for basic activities of daily living (ADL) difficulties, instrumental activities of daily living (IADL) difficulties, frailty, falls, and mortality (longitudinal only). Low ASM with limited mobility was associated with IADL difficulties (p = .008) and frailty (p = .040) but not with ADL difficulties or falls in cross-sectional analyses; and with ADL difficulties (p = .022), IADL difficulties (p = .006), frailty (p = .039), and mortality (p = .003) but not with falls in longitudinal analyses adjusted for age and gender. Low ASM alone was marginally associated with mortality (p = .085) but not with other outcomes in cross-sectional or longitudinal analyses. Low ASM with limited mobility is associated with poor health outcomes among late middle-aged African Americans.

  17. Acrophialophora, a Poorly Known Fungus with Clinical Significance

    PubMed Central

    Sandoval-Denis, Marcelo; Sutton, Deanna A.; Wiederhold, Nathan P.; Guarro, Josep

    2015-01-01

    Acrophialophora fusispora is an emerging opportunistic fungus capable of causing human infections. The taxonomy of the genus is not yet resolved and, in order to facilitate identification of clinical specimens, we have studied a set of clinical and environmental Acrophialophora isolates by morphological and molecular analyses. This set included the available type strains of Acrophialophora species and similar fungi, some of which were considered by various authors to be synonyms of A. fusispora. Sequence analysis of the large subunit (LSU) and internal transcribed spacer (ITS) regions of the nuclear ribosomal DNA and a fragment of the β-tubulin (Tub) gene revealed that Acrophialophora belongs in the family Chaetomiaceae and comprises three different species, i.e., A. fusispora, Acrophialophora levis, and Acrophialophora seudatica; the latter was previously included in the genus Ampullifera. The most prevalent species among clinical isolates was A. levis (72.7%), followed by A. fusispora (27.3%), both of which were isolated mostly from respiratory specimens (72.7%), as well as subcutaneous and corneal tissue samples. In general, of the eight antifungal drugs tested, voriconazole had the greatest in vitro activity, while all other agents showed poor in vitro activity against these fungi. PMID:25716450

  18. The Effect of School-Based Health Clinics on Teenage Pregnancy and Parenting Outcomes: An Integrated Literature Review

    ERIC Educational Resources Information Center

    Strunk, Julie A.

    2008-01-01

    Teenage pregnancy outcomes have become an increasing concern in the United States. Education and support of pregnant teens are critical factors that may determine good or poor pregnancy outcomes. Poor outcomes may include low birth weight, developmental delays, and poor academic performance. Although the number of teenagers experiencing pregnancy…

  19. An audit of the predictors of outcome in status epilepticus from a resource-poor country: a comparison with developed countries.

    PubMed

    Hassan, Haseeb; Rajiv, Keni Ravish; Menon, Ramshekhar; Menon, Deepak; Nair, Muralidharan; Radhakrishnan, Ashalatha

    2016-06-01

    Status epilepticus is a neurological emergency with significant morbidity and mortality. This study describes the clinical profile, treatment, and predictors of outcome of status epilepticus in a tertiary referral centre in a developing country and aims to highlight the similarities and differences from data available from the western world. A retrospective analysis of data of patients treated for status epilepticus was conducted from prospectively maintained records, between January 2000 and September 2010. The demographic data, clinical profile and investigations (including neuroimaging and EEG), aetiology, treatment, and outcomes were studied and compared with data available from the western world. The analysis included 108 events in 84 patients. A single episode of status epilepticus was treated in 72 patients (86%) and multiple status epilepticus events, ranging from two to six per patient, were managed in 12 patients (14%). Mean age was 24.1±20.3 years and 63% were males. The types of status epilepticus included convulsive status in 98 (90.7%), non-convulsive status in seven (6.5%), and myoclonic status in three (2.8%). The majority of events (60%) were remote symptomatic, 16% were acute symptomatic, 16% were of unexplained aetiology, and 8% were progressive symptomatic. In 85 events (79%), status epilepticus could be aborted with first and second-line drugs. The remaining 23 events (21%) progressed to refractory status epilepticus, among which, 13 (56%) were controlled with continuous intravenous midazolam infusion. Case fatality rate was 11%, neurological sequelae were reported in 22%, and 67% returned to baseline. Acute symptomatic status, older age, altered sensorium at the time of admission, and delayed hospitalisation were predictors of poor outcome. Aetiology was the most important determinant of outcome of status epilepticus, as in reports from the western world, with remote symptomatic aetiology secondary to gliosis being the most common

  20. The distribution of outcomes research papers across clinical journals.

    PubMed

    Goldsack, Jennifer; McLaughlin, Chris; Bristol, Mirar N; Loeb, Alex; Bergey, Meredith; Sonnad, Seema S

    2011-06-01

    This study examines the distribution of health outcomes research (HOR) studies in the clinical literature by clinical areas and journal impact factor. The authors reviewed 535 journals and divided the sample into higher and lower impact journals across four clinical area. Mann-Whitney and Kruskal-Wallis tests were used to examine differences across four categories of outcomes research articles published, specifically the incidence of articles in higher versus lower impact journals and differences across clinical areas. All high-impact journals published more safety and quality articles than process assessment, quality of life, or cost analysis studies. The number of each type of outcomes research study published was highly variable across all clinical areas. Only arthritis and outcomes research journals showed statistically significant differences between higher versus lower impact journals. Authors may benefit from considering these differences in their clinical specialty area when deciding where to submit HOR studies.

  1. Clinical Outcome Metrics for Optimization of Robust Training

    NASA Technical Reports Server (NTRS)

    Ebert, D.; Byrne, V. E.; McGuire, K. M.; Hurst, V. W., IV; Kerstman, E. L.; Cole, R. W.; Sargsyan, A. E.; Garcia, K. M,; Foy, M. H.; Dulchavsky, S. A.; hide

    2015-01-01

    The emphasis of this research is on the Human Research Program (HRP) Exploration Medical Capabilities (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.

  2. Pyruvate kinase M2 prevents apoptosis via modulating Bim stability and associates with poor outcome in hepatocellular carcinoma

    PubMed Central

    Li, Min; Zhang, Chao; Liu, Li-Li; Fu, Jia; Jin, Jie-Tian; Luo, Rong-Zhen; Zhang, Chris Zhiyi; Yun, Jing-Ping

    2015-01-01

    Pyruvate kinase M2 (PKM2) contributes to the Warburg effect, a hallmark of cancer. We showed that PKM2 levels were correlated with overall survival (hazard ration = 1.675, 95% confidence interval: 1.389–2.019, P < 0.001) and disease-free survival (hazard ration = 1.573, 95% confidence interval: 1.214–2.038, P < 0.001) in a cohort of 490 patients with HCC. The correlations were further validated in an independent cohort of 148 HCC patients. Multivariate analyses revealed that PKM2 was an independent indicator of poor outcome in HCC. The knockdown of PKM2 in HCC cells inhibited cell proliferation and induced apoptosis in vitro and in vivo. Bim siRNA markedly abolished the PKM2-depletion-induced apoptosis. PKM2 depletion decreased the degradation of Bim. In clinical samples, PKM2 expression was reversely correlated with Bim expression. Combination of PKM2 and Bim levels had the best prognostic significance. We suggest that PKM2 serves as a promising biomarker for poor prognosis of patients with HCC and its knockdown induces HCC apoptosis by stabilizing Bim. PMID:25788265

  3. Allogeneic hematopoietic cell transplantation in first remission abrogates poor outcomes associated with high-risk pediatric acute myeloid leukemia.

    PubMed

    Burke, Michael J; Wagner, John E; Cao, Qing; Ustun, Celalettin; Verneris, Michael R

    2013-07-01

    Despite remission rates of approximately 85% for children diagnosed with acute myeloid leukemia (AML), greater than 40% will die from relapsed disease. Patients with poor-risk molecular/cytogenetics and/or inadequate response to up-front therapy are typically considered high-risk (HR) and historically have poor outcomes with chemotherapy alone. We investigated whether allogeneic hematopoietic cell transplantation (allo-HCT) with best available donor in first remission (CR1) would abrogate the poor outcomes associated with HR AML in children and young adults treated with chemotherapy. We reviewed the outcomes of 50 consecutive children and young adults (ages 0 to 30 years) with AML who received a myeloablative allo-HCT between 2001 and 2010. Thirty-six patients (72%) were HR, defined as having FLT3-ITD mutations, 11q23 MLL rearrangements, chromosome 5 or 7 abnormalities, induction failure, and/or having persistent disease. The majority of patients received cyclophosphamide and total body irradiation conditioning, and graft-versus-host-disease (GVHD) prophylaxis was cyclosporine based. Transplantation outcomes for HR patients were compared to standard-risk patients, with no significant differences observed in overall survival (72% versus 78%, P = .72), leukemia-free survival (69% versus 79%, P = .62), relapse (11% versus 7%, P = .71), or treatment-related mortality (17% versus 14%, P = .89). Children and young adults with HR-AML have comparable outcomes to standard-risk patients following allo-HCT in CR1. Copyright © 2013 American Society for Blood and Marrow Transplantation. Published by Elsevier Inc. All rights reserved.

  4. Clinical features, management and outcomes of progressive outer retinal necrosis (PORN) in southern Thailand.

    PubMed

    Sittivarakul, Wantanee; Aui-aree, Nipat

    2009-03-01

    To study the demographics, clinical features, treatment, and visual outcomes of progressive outer retinal necrosis (PORN) in a group of Thai patients. All cases of AIDS with a clinical diagnosis of PORN in a major tertiary referral hospital in southern Thailand between January 2003 and June 2007 were retrospectively reviewed. Demographic data, clinical features, treatment regimens, and visual outcomes were analyzed. Seven patients (11 eyes) were studied. The mean age was 44.7 years. The median CD4 count was 12 cells/mm3. A known history of cutaneous zoster was documented in 57% of cases. The median follow-up period was 17 weeks. Fifty-seven percent of the patients had bilateral disease. A majority of eyes (45.4%) had initial visual acuity of less than 20/50 to equal to or better than 20/200. About two-thirds of the eyes had anterior chamber cells. Vitritis and retinal lesions scattered throughout both posterior pole and peripheral retina were found in 72.7%. Either intravenous acyclovir in combination with intravitreal ganciclovir injections or intravenous aclyclovir alone was used for initial treatment. Retinal detachment occurred in 54.5%. Final visual acuity worsened (loss of 3 lines on the ETDRS chart or more) in 60%. Visual acuity was no light perception in 45.5% at the final recorded follow-up. Demographics, clinical features and treatment outcomes of PORN in this group of Thai patients were comparable with studies from other countries. Visual prognosis is still poor with current treatment regimens.

  5. Epidemic Pseudomonas aeruginosa infection in patients with cystic fibrosis is not a risk factor for poor clinical Outcomes following lung transplantation.

    PubMed

    Pritchard, Julia; Thakrar, Mitesh V; Somayaji, Ranjani; Surette, Michael G; Rabin, Harvey R; Helmersen, Doug; Lien, Dale; Purighalla, Swathi; Waddell, Barbara; Parkins, Michael D

    2016-05-01

    Epidemic strains of Pseudomonas aeruginosa (ePA) causing infection in cystic fibrosis (CF) have been commonly identified from clinics around the world. ePA disproportionally impacts CF patient pre-transplant outcomes manifesting in increased exacerbation frequency, worsened treatment burden and increased rate of lung function decline, and disproportionally leads to death and/or transplantation. As other CF factors such as pre-transplant infection with multi-resistant organisms, and isolation of P. aeruginosa in the post transplant graft, may impact post-transplant outcomes, we sought to determine if infection with ePA similarly adversely impact post-transplant outcomes. Between 1991-2014, 53 CF patients from our center received lung transplants. Bacterial strain typing was performed retrospectively on isolates collected prior to transplantation. Comprehensive chart reviews were performed to obtain baseline patient characteristics and post-transplant outcomes. Of the 53 transplanted patients, 57% of patients were infected with ePA prior to transplant; the other 43% of patients had unique strains of P. aeruginosa. Mean age at transplant was 29.0years for ePA and 33.3years for unique (p=0.04). There were no differences in overall survival (HR=0.75, 95% CI 0.31-1.79), bronchiolitis obliterans syndrome (BOS) free survival (HR 1.43, 95% CI 0.54-4.84) or all other assessed outcomes including exacerbation frequency, chronic renal failure, acute cellular rejections, Aspergillus infection, airway stenosis, and post-transplant lymphoproliferative disorder. Unlike pre-transplant outcomes, CF patients infected with ePA do not experience worse post-transplant outcomes than those infected with unique strains. Therefore, lung transplantation should be considered for all patients with P. aeruginosa infection and end stage lung disease, irrespective of infection with ePA. Copyright © 2015 European Cystic Fibrosis Society. Published by Elsevier B.V. All rights reserved.

  6. Trending Fibrinolytic Dysregulation: Fibrinolysis Shutdown in the Days After Injury Is Associated With Poor Outcome in Severely Injured Children.

    PubMed

    Leeper, Christine M; Neal, Matthew D; McKenna, Christine J; Gaines, Barbara A

    2017-09-01

    To trend fibrinolysis after injury and determine the influence of traumatic brain injury (TBI) and massive transfusion on fibrinolysis status. Admission fibrinolytic derangement is common in injured children and adults, and is associated with poor outcome. No studies examine fibrinolysis days after injury. Prospective study of severely injured children at a level 1 pediatric trauma center. Rapid thromboelastography was obtained on admission and daily for up to 7 days. Standard definitions of hyperfibrinolysis (HF; LY30 ≥3), fibrinolysis shutdown (SD; LY30 ≤0.8), and normal (LY30 = 0.9-2.9) were applied. Antifibrinolytic use was documented. Outcomes were death, disability, and thromboembolic complications. Wilcoxon rank-sum and Fisher exact tests were performed. Exploratory subgroups included massively transfused and severe TBI patients. In all, 83 patients were analyzed with median (interquartile ranges) age 8 (4-12) and Injury Severity Score 22 (13-34), 73.5% blunt mechanism, 47% severe TBI, 20.5% massively transfused. Outcomes were 14.5% mortality, 43.7% disability, and 9.8% deep vein thrombosis. Remaining in or trending to SD was associated with death (P = 0.007), disability (P = 0.012), and deep vein thrombosis (P = 0.048). Median LY30 was lower on post-trauma day (PTD)1 to PTD4 in patients with poor compared with good outcome; median LY30 was lower on PTD1 to PTD3 in TBI patients compared with non-TBI patients. HF without associated shutdown was not related to poor outcome, but extreme HF (LY30 >30%, n = 3) was lethal. Also, 50% of massively transfused patients in hemorrhagic shock demonstrated SD physiology on admission. All with HF (fc31.2%) corrected after hemostatic resuscitation without tranexamic acid. Fibrinolysis shutdown is common postinjury and predicts poor outcomes. Severe TBI is associated with sustained shutdown. Empiric antifibrinolytics for children should be questioned; thromboelastography-directed selective use should be considered for

  7. Familiality and clinical outcomes of sleep disturbances in major depressive and bipolar disorders.

    PubMed

    Lai, Yin-Chieh; Huang, Ming-Chyi; Chen, Hsi-Chung; Lu, Ming-Kun; Chiu, Yi-Hang; Shen, Winston W; Lu, Ru-Band; Kuo, Po-Hsiu

    2014-01-01

    Sleep disturbances are frequently observed in major depressive (MDD) and bipolar disorder (BD). This study reported sleep profiles of patients and their relatives versus controls, and examined the familiality of sleep features in mood disorder families. We also evaluated the influences of sleep disturbance on patients' quality of life (QOL), functional impairment, and suicidality. We recruited 363 BD and 157 MDD patients, 521 first-degree relatives, and 235 healthy controls, which completed a diagnostic interview, Pittsburgh Sleep Quality Index (PSQI), and QOL questionnaire. The magnitude of heritability of sleep features was calculated and familiality was evaluated by mixed regression models and intraclass correlation coefficient (ICC). The associations between sleep problems and clinical outcomes were examined using multiple regression models. More than three-quarters of mildly-ill patients were classified as "poor sleepers". MDD patients had significantly worse sleep quality as compared to BD patients. Moderate but significant familial aggregation was observed in subjective sleep quality, sleep latency, disturbance, daytime dysfunction, and global score (ICC=0.10-0.21, P<.05). Significant heritability was found in sleep quality (0.45, P<.001) and sleep disturbance (0.23, P<.001). Patients with good sleep quality had better QOL and less functional impairment (P<.05) than poor sleepers. Poor sleep quality and nightmares further increased the risk for suicidal ideation (ORadj=2.8) and suicide attempts (ORadj=1.9-2.8). Subjectively measured sleep features demonstrated significant familiality. Poor sleep quality further impaired patients' daily function and QOL, in addition to increasing the risk of suicidality, and thus requires special attention in related clinical settings. Copyright © 2013 Elsevier Inc. All rights reserved.

  8. Benchmarking Outpatient Rehabilitation Clinics Using Functional Status Outcomes.

    PubMed

    Gozalo, Pedro L; Resnik, Linda J; Silver, Benjamin

    2016-04-01

    To utilize functional status (FS) outcomes to benchmark outpatient therapy clinics. Outpatient therapy data from clinics using Focus on Therapeutic Outcomes (FOTO) assessments. Retrospective analysis of 538 clinics, involving 2,040 therapists and 90,392 patients admitted July 2006-June 2008. FS at discharge was modeled using hierarchical regression methods with patients nested within therapists within clinics. Separate models were estimated for all patients, for those with lumbar, and for those with shoulder impairments. All models risk-adjusted for intake FS, age, gender, onset, surgery count, functional comorbidity index, fear-avoidance level, and payer type. Inverse probability weighting adjusted for censoring. Functional status was captured using computer adaptive testing at intake and at discharge. Clinic and therapist effects explained 11.6 percent of variation in FS. Clinics ranked in the lowest quartile had significantly different outcomes than those in the highest quartile (p < .01). Clinics ranked similarly in lumbar and shoulder impairments (correlation = 0.54), but some clinics ranked in the highest quintile for one condition and in the lowest for the other. Benchmarking models based on validated FS measures clearly separated high-quality from low-quality clinics, and they could be used to inform value-based-payment policies. © Health Research and Educational Trust.

  9. Stunting is associated with poor outcomes in childhood pneumonia

    PubMed Central

    Moschovis, Peter P.; Addo-Yobo, Emmanuel O. D.; Banajeh, Salem; Chisaka, Noel; Christiani, David C.; Hayden, Douglas; Jeena, Prakash; MacLeod, William B.; Mino, Greta; Patel, Archana; Qazi, Shamim; Santosham, Mathuram; Thea, Donald M.; Hibberd, Patricia L.

    2015-01-01

    Objective Stunting affects 26.7% of children worldwide, and little is known about its effects on the outcomes of childhood pneumonia. We evaluated the effect of stunting on the outcomes of pneumonia among children enrolled in two large clinical trials. Methods We analyzed data from two WHO and USAID-sponsored inpatient treatment trials, the Severe Pneumonia Evaluation Antimicrobial Research study (n=958) and the Amoxicillin Penicillin Pneumonia International Study (n=1702), which enrolled children aged 2–59 months across 16 sites in LMICs. We assessed the effect of stunting (height-for-age Z score < −2) on treatment outcome and time to resolution of hypoxemic pneumonia. Results Among 2542 (96%) children with valid data for height, 28% were stunted and 12.8% failed treatment by 5 days. The failure rate among stunted patients was 16.0% vs. 11.5% among non-stunted patients (unadjusted RR = 1.24 [95% CI 1.08, 1.41]; adjusted RR = 1.28 [95% CI 1.10, 1.48]). An inverse relationship was observed between height and failure rates, even among non-stunted children. Among 845 patients with hypoxemic pneumonia, stunting was associated with a lower probability of normalization of respiratory rate (HR = 0.63 [95% CI 0.52, 0.75]) and oxygen saturation (HR = 0.74 [95% CI 0.61, 0.89]). Conclusions Stunting increases the risk of treatment failure and is associated with a longer course of recovery in children with pneumonia. Strategies to decrease stunting may decrease the burden of adverse outcomes in childhood pneumonia in low-resource settings. PMID:26083963

  10. Correlation between CD34 expression and chromosomal abnormalities but not clinical outcome in acute myeloid leukemia.

    PubMed

    Fruchart, C; Lenormand, B; Bastard, C; Boulet, D; Lesesve, J F; Callat, M P; Stamatoullas, A; Monconduit, M; Tilly, H

    1996-11-01

    The hemopoietic stem cell marker CD34 has been reported to be a useful predictor of treatment outcome in acute myeloid leukemia (AML). Previous data suggested that CD34 expression may be associated with other poor prognosis factors in AML such as undifferentiated leukemia, secondary AML (SAML), and clonal abnormalities involving chromosome 5 and 7. In order to analyze the correlations between the clinicopathologic features, cytogenetic and CD34 expression in AML, we retrospectively investigated 99 patients with newly diagnosed AML: 85 with de novo disease and 14 with secondary AML (SAML). Eighty-six patients who received the same induction chemotherapy were available for clinical outcome. Defining a case as positive when > or = 20% of bone marrow cells collected at diagnosis expressed the CD34 antigen, forty-five patients were included in the CD34 positive group. Ninety patients had adequate cytogenetic analysis. Thirty-two patients (72%) with CD34 positive AML exhibited an abnormal karyotype whereas 15 patients (28%) with CD34 negative AML had abnormal metaphases (P < 0.01). Monosomy 7/7q- or monosomy 5/5q- occurred in 10 patients and 8 of them expressed the CD34 antigen (P < 0.05). All patients with t(8;21) which is considered as a favorable factor in AML had levels of CD34 >/= 20% (P < 0.05). We did not find any association between CD34 expression and attainment of complete remission, overall survival, or disease-free survival. In conclusion, the variations of CD34 expression in AML are correlated with cytogenetic abnormalities associated both with poor and favorable outcome. The evaluation of the correlations between CD34 antigen and clinical outcome in AML should take into account the results of pretreatment karyotype.

  11. Parent-Adolescent Discrepancies in Perceived Parenting Characteristics and Adolescent Developmental Outcomes in Poor Chinese Families.

    PubMed

    Leung, Janet T Y; Shek, Daniel T L

    2014-01-01

    We examined the relationships between parent-adolescent discrepancies in perceived parenting characteristics (indexed by parental responsiveness, parental demandingness, and parental control) and adolescent developmental outcomes (indexed by achievement motivation and psychological competence) in poor families in Hong Kong. A sample of 275 intact families having at least one child aged 11-16 experiencing economic disadvantage were invited to participate in the study. Fathers and mothers completed the Parenting Style Scale and Chinese Parental Control Scale, and adolescents completed the Social-Oriented Achievement Motivation Scale and Chinese Positive Youth Development Scale in addition to paternal and maternal Parenting Style Scale and Chinese Parental Control Scale. Results indicated that parents and adolescents had different perceptions of parental responsiveness, parental demandingness, and paternal control, with adolescents generally perceived lower levels of parenting behaviors than did their parents. While father-adolescent discrepancy in perceived paternal responsiveness and mother-adolescent discrepancy in perceived maternal control negatively predicted adolescent achievement motivation, mother-adolescent discrepancy in perceptions of maternal responsiveness negatively predicted psychological competence in adolescents experiencing economic disadvantage. The present findings provided support that parent-child discrepancies in perceived parenting characteristics have negative impacts on the developmental outcomes of adolescents experiencing economic disadvantage. The present study addresses parent-child discrepancies in perceived parental behaviors as "legitimate" constructs, and explores their links with adolescent psychosocial development, which sheds light for researchers and clinical practitioners in helping the Chinese families experiencing economic disadvantage.

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

    PubMed

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

    2016-01-01

    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. 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. 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. 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.

  13. Garment workers in California: health outcomes of the Asian Immigrant Women Workers Clinic.

    PubMed

    Burgel, Barbara J; Lashuay, Nan; Israel, Leslie; Harrison, Robert

    2004-11-01

    In this cross sectional descriptive study, the demographics, risk factors, and health outcomes of a volunteer, symptomatic sample of monolingual Cantonese garment workers in the Oakland, California Chinatown area are documented. Methods included a questionnaire and clinical examination and treatment at the Asian Immigrant Women Workers Clinic, a free clinic providing culturally focused occupational health consultation and treatment for painful musculoskeletal disorders. Because garment work involves highly repetitious, sustained awkward postures, focused education on stretching and ergonomics also was provided. Results from the first 100 clients revealed a highly symptomatic sample, with an average age of 48.7 years. Sixty-six percent rated their health status as fair or poor. Sixteen percent of the sample had nerve entrapments, and 99% had a diagnosed strain or sprain of the spine or upper extremities. This population did not file workers' compensation claims because of a lack of knowledge and a fear of reprisal. This study documented the barriers to seeking care for this low wage, immigrant population.

  14. Physical performance and clinical outcomes in dialysis patients: a secondary analysis of the EXCITE trial.

    PubMed

    Torino, Claudia; Manfredini, Fabio; Bolignano, Davide; Aucella, Filippo; Baggetta, Rossella; Barillà, Antonio; Battaglia, Yuri; Bertoli, Silvio; Bonanno, Graziella; Castellino, Pietro; Ciurlino, Daniele; Cupisti, Adamasco; D'Arrigo, Graziella; De Paola, Luciano; Fabrizi, Fabrizio; Fatuzzo, Pasquale; Fuiano, Giorgio; Lombardi, Luigi; Lucisano, Gaetano; Messa, Piergiorgio; Rapanà, Renato; Rapisarda, Francesco; Rastelli, Stefania; Rocca-Rey, Lisa; Summaria, Chiara; Zuccalà, Alessandro; Tripepi, Giovanni; Catizone, Luigi; Zoccali, Carmine; Mallamaci, Francesca

    2014-01-01

    Scarce physical activity predicts shorter survival in dialysis patients. However, the relationship between physical (motor) fitness and clinical outcomes has never been tested in these patients. We tested the predictive power of an established metric of motor fitness, the Six-Minute Walking Test (6MWT), for death, cardiovascular events and hospitalization in 296 dialysis patients who took part in the trial EXCITE (ClinicalTrials.gov Identifier: NCT01255969). During follow up 69 patients died, 90 had fatal and non-fatal cardiovascular events, 159 were hospitalized and 182 patients had the composite outcome. In multivariate Cox models - including the study allocation arm and classical and non-classical risk factors - an increase of 20 walked metres during the 6MWT was associated to a 6% reduction of the risk for the composite end-point (P=0.001) and a similar relationship existed between the 6MWT, mortality (P<0.001) and hospitalizations (P=0.03). A similar trend was observed for cardiovascular events but this relationship did not reach statistical significance (P=0.09). Poor physical performance predicts a high risk of mortality, cardiovascular events and hospitalizations in dialysis patients. Future studies, including phase-2 EXCITE, will assess whether improving motor fitness may translate into better clinical outcomes in this high risk population. © 2014 S. Karger AG, Basel.

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

    ERIC Educational Resources Information Center

    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…

  16. Right ventricular dysfunction after resuscitation predicts poor outcomes in cardiac arrest patients independent of left ventricular function.

    PubMed

    Ramjee, Vimal; Grossestreuer, Anne V; Yao, Yuan; Perman, Sarah M; Leary, Marion; Kirkpatrick, James N; Forfia, Paul R; Kolansky, Daniel M; Abella, Benjamin S; Gaieski, David F

    2015-11-01

    Determination of clinical outcomes following resuscitation from cardiac arrest remains elusive in the immediate post-arrest period. Echocardiographic assessment shortly after resuscitation has largely focused on left ventricular (LV) function. We aimed to determine whether post-arrest right ventricular (RV) dysfunction predicts worse survival and poor neurologic outcome in cardiac arrest patients, independent of LV dysfunction. A single-center, retrospective cohort study at a tertiary care university hospital participating in the Penn Alliance for Therapeutic Hypothermia (PATH) Registry between 2000 and 2012. 291 in- and out-of-hospital adult cardiac arrest patients at the University of Pennsylvania who had return of spontaneous circulation (ROSC) and post-arrest echocardiograms. Of the 291 patients, 57% were male, with a mean age of 59 ± 16 years. 179 (63%) patients had LV dysfunction, 173 (59%) had RV dysfunction, and 124 (44%) had biventricular dysfunction on the initial post-arrest echocardiogram. Independent of LV function, RV dysfunction was predictive of worse survival (mild or moderate: OR 0.51, CI 0.26-0.99, p<0.05; severe: OR 0.19, CI 0.06-0.65, p=0.008) and neurologic outcome (mild or moderate: OR 0.33, CI 0.17-0.65, p=0.001; severe: OR 0.11, CI 0.02-0.50, p=0.005) compared to patients with normal RV function after cardiac arrest. Echocardiographic findings of post-arrest RV dysfunction were equally prevalent as LV dysfunction. RV dysfunction was significantly predictive of worse outcomes in post-arrest patients after accounting for LV dysfunction. Post-arrest RV dysfunction may be useful for risk stratification and management in this high-mortality population. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

  17. Live birth rates in the different combinations of the Bologna criteria poor ovarian responders: a validation study.

    PubMed

    La Marca, Antonio; Grisendi, Valentina; Giulini, Simone; Sighinolfi, Giovanna; Tirelli, Alessandra; Argento, Cindy; Re, Claudia; Tagliasacchi, Daniela; Marsella, Tiziana; Sunkara, Sesh Kamal

    2015-06-01

    to compare the baseline characteristics and chance of live birth in the different categories of poor responders identified by the combinations of the Bologna criteria and establish whether these groups comprise a homogenous population. database containing clinical and laboratory information on IVF treatment cycles carried out at the Mother-Infant Department of the University Hospital of Modena between year 2007 and 2011 was analysed. This data was collected prospectively and recorded in the registered database of the fertility centre. Eight hundred and thirty women fulfilled the inclusion/ exclusion criteria of the study and 210 women fulfilled the Bologna criteria definition for poor ovarian response (POR). Five categories of poor responders were identified by different combinations of the Bologna criteria. There were no significant differences in female age, AFC, AMH, cycle cancellation rate and number of retrieved oocytes between the five groups. The live birth rate ranged between 5.5 and 7.4 % and was not statistically different in the five different categories of women defined as poor responders according to the Bologna criteria. The study demonstrates that the different groups of poor responders based on the Bologna criteria have similar IVF outcomes. This information validates the Bologna criteria definition as women having a uniform poor prognosis and also demonstrates that the Bologna criteria poor responders in the various subgroups represent a homogenous population with similar pre-clinical and clinical outcomes.

  18. Effects of decompressive craniectomy on functional outcomes and death in poor-grade aneurysmal subarachnoid hemorrhage: a systematic review and meta-analysis.

    PubMed

    Alotaibi, Naif M; Elkarim, Ghassan Awad; Samuel, Nardin; Ayling, Oliver G S; Guha, Daipayan; Fallah, Aria; Aldakkan, Abdulrahman; Jaja, Blessing N R; de Oliveira Manoel, Airton Leonardo; Ibrahim, George M; Macdonald, R Loch

    2017-12-01

    OBJECTIVE Patients with poor-grade aneurysmal subarachnoid hemorrhage (aSAH) (World Federation of Neurosurgical Societies Grade IV or V) are often considered for decompressive craniectomy (DC) as a rescue therapy for refractory intracranial hypertension. The authors performed a systematic review and meta-analysis to assess the impact of DC on functional outcome and death in patients after poor-grade aSAH. METHODS A systematic review and meta-analysis were performed in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Articles were identified through the Ovid Medline, Embase, Web of Science, and Cochrane Library databases from inception to October 2015. Only studies dedicated to patients with poor-grade aSAH were included. Primary outcomes were death and functional outcome assessed at any time period. Patients were grouped as having a favorable outcome (modified Rankin Scale [mRS] Scores 1-3, Glasgow Outcome Scale [GOS] Scores 4 and 5, extended Glasgow Outcome Scale [GOSE] Scores 5-8) or unfavorable outcome (mRS Scores 4-6, GOS Scores 1-3, GOSE Scores 1-4). Pooled estimates of event rates and odds ratios with 95% confidence intervals were calculated using the random-effects model. RESULTS Fifteen studies encompassing 407 patients were included in the meta-analysis (all observational cohorts). The pooled event rate for poor outcome across all studies was 61.2% (95% CI 52%-69%) and for death was 27.8% (95% CI 21%-35%) at a median of 12 months after aSAH. Primary (or early) DC resulted in a lower overall event rate for unfavorable outcome than secondary (or delayed) DC (47.5% [95% CI 31%-64%] vs 74.4% [95% CI 43%-91%], respectively). Among studies with comparison groups, there was a trend toward a reduced mortality rate 1-3 months after discharge among patients who did not undergo DC (OR 0.58 [95% CI 0.27-1.25]; p = 0.168). However, this trend was not sustained at the 1-year follow-up (OR 1.09 [95% CI 0

  19. Clinical outcomes and contributors to weight loss in a cancer cachexia clinic.

    PubMed

    Del Fabbro, Egidio; Hui, David; Dalal, Shalini; Dev, Rony; Nooruddin, Zohra I; Noorhuddin, Zohra; Bruera, Eduardo

    2011-09-01

    Cancer cachexia is considered intractable, with few therapeutic options. Secondary nutrition impact symptoms (S-NIS) such as nausea may further contribute to weight loss by decreasing nutrient intake. In addition, treatable metabolic abnormalities such as hypogonadism, vitamin B12 deficiency, hypothyroidism, and hypoadrenalism could exacerbate anorexia and muscle wasting in patients with cancer cachexia. We determined the frequency and type of contributors to appetite and weight loss, and the effect of the cachexia clinic on clinical outcomes. Review of 151 consecutive patients referred to a cachexia clinic. All received dietary counseling and exercise recommendations. Assessments included weight, body mass index (BMI), S-NIS, resting energy expenditure by indirect calorimetry, serum thyroid stimulating hormone (TSH), cortisol, total testosterone, and vitamin B12. Median weight loss in the 100 days before referral was 9% (4%-13%); median BMI at presentation was 20.8. Median number of S-NIS was 3 (2-4), most commonly treated by metoclopramide, laxatives, and antidepressants. Forty-one percent (24/59) of patients were hypermetabolic and 73% (52/71) of males hypogonadic, whereas hypoadrenalism (0/101, 0%), hypothyroidism (4/113, 4%), and low vitamin B12 (3/107, 3%) were uncommon. Poor appetite and weight loss before referral (r = 0.18, p = 0.036) were associated with increased S-NIS (r = 0.22, p = 0.008). Appetite improved (p < 0.001) and 31/92 (34%) of patients returning for a second visit gained weight. Patients had a high frequency of multiple S-NIS, hypogonadism, and hypermetabolism. A combination of simple pharmacological and nonpharmacological interventions improved appetite significantly, and increased weight in one third of patients who were able to return for follow-up. Cachexia clinics are feasible and effective for many patients with advanced cancer.

  20. Clinical Outcome Metrics for Optimization of Robust Training

    NASA Technical Reports Server (NTRS)

    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

  1. Occurrence, clinical features and outcome of canine pancreatitis (80 cases).

    PubMed

    Pápa, Kinga; Máthé, Akos; Abonyi-Tóth, Zsolt; Sterczer, Agnes; Psáder, Roland; Hetyey, Csaba; Vajdovich, Péter; Vörös, Károly

    2011-03-01

    Medical records of 80 dogs diagnosed with acute pancreatitis during a 4-year period were evaluated regarding history, breed predilection, clinical signs and additional examination findings. Cases were selected if compatible clinical symptoms, increased serum activity of amylase or lipase and morphologic evidence of pancreatitis by ultrasonography, laparotomy or necropsy were all present. Like in other studies, neutered dogs had an increased risk of developing acute pancreatitis. Although breed predilection was consistent with earlier reports, some notable differences were also observed. Apart from Dachshunds, Poodles, Cocker Spaniels and Fox Terriers, the sled dogs (Laikas, Alaskan Malamutes) also demonstrated a higher risk for pancreatitis according to our results. Concurrent diseases occurred in 56 dogs (70%), diabetes mellitus (n = 29, 36%) being the most common. Clinical signs of acute pancreatitis were similar to those observed in other studies. The study group represented a dog population with severe acute pancreatitis, having a relatively high mortality rate (40%) compared to data of the literature. Breed, age, gender, neutering and body condition had no significant association with the outcome. Hypothermia (p = 0.0413) and metabolic acidosis (p = 0.0063) correlated significantly with poor prognosis and may serve as valuable markers for severity assessment in canine acute pancreatitis.

  2. Computed Tomographic Perfusion Predicts Poor Outcomes in a Randomized Trial of Endovascular Therapy.

    PubMed

    Wannamaker, Robert; Guinand, Taurian; Menon, Bijoy K; Demchuk, Andrew; Goyal, Mayank; Frei, Donald; Bharatha, Aditya; Jovin, Tudor G; Shankar, Jai; Krings, Timo; Baxter, Blaise; Holmstedt, Christine; Swartz, Richard; Dowlatshahi, Dar; Chan, Richard; Tampieri, Donatella; Choe, Hana; Burns, Paul; Gentile, Nina; Rempel, Jeremy; Shuaib, Ashfaq; Buck, Brian; Bivard, Andrew; Hill, Michael; Butcher, Kenneth

    2018-06-01

    In the ESCAPE trial (Endovascular Treatment for Small Core and Anterior Circulation Proximal Occlusion with Emphasis on Minimizing CT to Recanalization Times), patients with large vessel occlusions and small infarct cores identified with computed tomography (CT)/CT angiography were randomized to endovascular therapy or standard of care. CT perfusion (CTP) was obtained in some cases but was not used to select patients. We tested the hypothesis that patients with penumbral CTP patterns have higher rates of good clinical outcome. All CTP data acquired in ESCAPE patients were analyzed centrally using a semiautomated perfusion threshold-based approach. A penumbral pattern was defined as an infarct core <70 mL, penumbral volume >15 mL, and a total hypoperfused volume:core volume ratio of >1.8. The primary outcome was good functional outcome at 90 days (modified Rankin Scale score, 0-2). CTP was acquired in 138 of 316 ESCAPE patients. Penumbral patterns were present in 116 of 128 (90.6%) of patients with interpretable CTP data. The rate of good functional outcome in penumbral pattern patients (53 of 114; 46%) was higher than that in nonpenumbral patients (2 of 12; 17%; P =0.041). In penumbral patients, endovascular therapy increased the likelihood of a good clinical outcome (34 of 58; 57%) compared with those in the control group (19 of 58; 33%; odds ratio, 2.68; 95% confidence interval, 1.25-5.76; P =0.011). Only 3 of 12 nonpenumbral patients were randomized to the endovascular group, preventing an analysis of treatment effect. The majority of patients with CTP imaging in the ESCAPE trial had penumbral patterns, which were associated with better outcomes overall. Patients with penumbra treated with endovascular therapy had the greatest odds of good functional outcome. Nonpenumbral patients were much less likely to achieve good outcomes. © 2018 American Heart Association, Inc.

  3. Factors associated with unintended pregnancy, poor birth outcomes and post-partum contraceptive use among HIV-positive female adolescents in Kenya

    PubMed Central

    2012-01-01

    Background Although the experiences of unintended pregnancies and poor birth outcomes among adolescents aged 15–19 years in the general population are well documented, there is limited understanding of the same among those who are living with HIV. This paper examines the factors associated with experiencing unintended pregnancies, poor birth outcomes, and post-partum contraceptive use among HIV-positive female adolescents in Kenya. Methods Data are from a cross-sectional study that captured information on pregnancy histories of HIV-positive female adolescents in four regions of Kenya: Coast, Nairobi, Nyanza and Rift Valley provinces. Study participants were identified through HIV and AIDS programs in the four regions. Out of a total of 797 female participants, 394 had ever been pregnant with 24% of them experiencing multiple pregnancies. Analysis entails the estimation of random-effects logit models. Results Higher order pregnancies were just as likely to be unintended as lower order ones (odds ratios [OR]: 1.2; 95% confidence interval [CI]: 0.8–2.0) while pregnancies occurring within marital unions were significantly less likely to be unintended compared to those occurring outside such unions (OR: 0.1; 95% CI: 0.1–0.2). Higher order pregnancies were significantly more likely to result in poor outcomes compared to lower order ones (OR: 2.5; 95% CI: 1.6–4.0). In addition, pregnancies occurring within marital unions were significantly less likely to result in poor outcomes compared to those occurring outside such unions (OR: 0.3; 95% CI: 0.1–0.9). However, experiencing unintended pregnancy was not significantly associated with adverse birth outcomes (OR: 1.3; 95% CI: 0.5–3.3). There was also no significant difference in the likelihood of post-partum contraceptive use by whether the pregnancy was unintended (OR: 0.9; 95% CI: 0.5–1.5). Conclusions The experience of repeat unintended pregnancies among HIV-positive female adolescents in the sample is partly

  4. [Clinical outcome and prognosis of neonatal bacterial meningitis].

    PubMed

    Ben Hamouda, H; Ben Haj Khalifa, A; Hamza, M A; Ayadi, A; Soua, H; Khedher, M; Sfar, M T

    2013-09-01

    To study the epidemiological, clinical, and bacteriological aspects as well as the outcome of neonatal bacterial meningitis and analyze the factors of poor prognosis of this condition. We report a retrospective analysis of 44 cases of neonatal bacterial meningitis hospitalized in the pediatric unit of Tahar Sfar Hospital in Mahdia, Tunisia, between January 1996 and December 2010. Inclusion criteria were infants less than 29 days of age who were hospitalized for bacterial meningitis diagnosed on either the presence of bacteria in cerebrospinal fluid or with more than 50 cells/mm(3), predominance of neutrophils, and the protein level greater than 1.2g/l. Clinical data were obtained through the analysis of patient files. Statistical analysis was based on the Chi(2) test, and P-values less than 0.05 were considered statistically significant. The incidence of neonatal bacterial meningitis was 0.49 per 1000 live births. The patients were premature in 20.4 % and low birth weight in 13.6 % of cases. The clinical presentation was not specific for most cases. The main signs at admission were hyperthermia (43.2 %), refusal to nurse (20.4 %), seizures (18.2 %), and respiratory distress (13.6 %). The cerebrospinal fluid culture was positive in 36.4 % of cases. The group B streptococcus was the most frequently isolated (62.5 %) followed by Escherichia coli (12.5 %). The association of cefotaxime-ampicillin-gentamicin was used as the first treatment in all cases. Ofloxacin was associated with initial antibiotic therapy during the first 5 days in 20.4 % of cases. The mortality rate was 15.9 % and the rate of neurological sequelae in survivors was 21.6 %. Prematurity, low birth weight, shock, respiratory distress, and pleocytosis of less than 500 cells/mm(3) were the main factors of a poor prognosis. The addition of ofloxacin to the initial antibiotic therapy was associated with a decreased rate of neurological sequelae in survivors (11 % vs. 25 %, P=0.042). This study emphasizes

  5. The impact of patient-reported outcome measures in clinical practice for pain: a systematic review.

    PubMed

    Holmes, Michelle M; Lewith, George; Newell, David; Field, Jonathan; Bishop, Felicity L

    2017-02-01

    Patient-reported outcome measures (PROMs) have increasingly been incorporated into clinical practice. Research suggests that PROMs could be viewed as active components of complex interventions and may affect the process and outcome of care. This systematic review examines PROMs in the context of treatment for non-malignant pain. An electronic search on: MEDLINE, EMBASE, PsycINFO, PsycARTICLES, Cochrane Library and Web of Science identified relevant papers (February 2015). The inclusion criteria were: focused on implementing PROMs into clinical practice, adults, and primary data studies. Critical interpretive synthesis was used to synthesise qualitative and quantitative findings into a theoretical argument. Thirteen eligible studies were identified. Synthesis suggested that PROMs may be included in the initial consultation to assess patients and for shared decision-making regarding patient care. During the course of treatment, PROMs can be used to track progress, evaluate treatment, and change the course of care; using PROMs may also influence the therapeutic relationship. Post-treatment, using PROMs might directly influence other outcomes such as pain and patient satisfaction. However, although studies have investigated these areas, evidence is weak and inconclusive. Due to the poor quality, lack of generalisability and heterogeneity of these studies, it is not possible to provide a comprehensive understanding of how PROMs may impact clinical treatment of non-malignant pain. The literature suggests that PROMs enable pain assessment, decision-making, the therapeutic relationship, evaluation of treatment and may influence outcomes. Further research is needed to provide better evidence as to whether PROMs do indeed have any effects on these domains.

  6. Stunting is associated with poor outcomes in childhood pneumonia.

    PubMed

    Moschovis, Peter P; Addo-Yobo, Emmanuel O D; Banajeh, Salem; Chisaka, Noel; Christiani, David C; Hayden, Douglas; Jeena, Prakash; MacLeod, William B; Mino, Greta; Patel, Archana; Qazi, Shamim; Santosham, Mathuram; Thea, Donald M; Hibberd, Patricia L

    2015-10-01

    Stunting affects 26.7% of children worldwide, and little is known about its effects on the outcomes of childhood pneumonia. We evaluated the effect of stunting on the outcomes of pneumonia among children enrolled in two large clinical trials. We analysed data from two WHO and USAID-sponsored inpatient treatment trials, the Severe Pneumonia Evaluation Antimicrobial Research study (n = 958) and the Amoxicillin Penicillin Pneumonia International Study (n = 1702), which enrolled children aged 2-59 months across 16 sites in LMICs. We assessed the effect of stunting (height-for-age Z score < -2) on treatment outcome and time to resolution of hypoxaemic pneumonia. Among 2542 (96%) children with valid data for height, 28% were stunted and 12.8% failed treatment by 5 days. The failure rate among stunted patients was 16.0% vs. 11.5% among non-stunted patients [unadjusted RR = 1.24 (95% CI 1.08, 1.41); adjusted RR = 1.28 (95% CI 1.10, 1.48)]. An inverse relationship was observed between height and failure rates, even among non-stunted children. Among 845 patients with hypoxaemic pneumonia, stunting was associated with a lower probability of normalisation of respiratory rate [HR = 0.63 (95% CI 0.52, 0.75)] and oxygen saturation [HR = 0.74 (95% CI 0.61, 0.89)]. Stunting increases the risk of treatment failure and is associated with a longer course of recovery in children with pneumonia. Strategies to decrease stunting may decrease the burden of adverse outcomes in childhood pneumonia in low-resource settings. © 2015 John Wiley & Sons Ltd.

  7. High MRPS23 expression contributes to hepatocellular carcinoma proliferation and indicates poor survival outcomes.

    PubMed

    Pu, Meng; Wang, Jianlin; Huang, Qike; Zhao, Ge; Xia, Congcong; Shang, Runze; Zhang, Zhuochao; Bian, Zhenyuan; Yang, Xishegn; Tao, Kaishan

    2017-07-01

    Hepatocellular carcinoma is one of the most prevalent neoplasms and the leading cause of cancer-related mortality worldwide. Mitochondrial ribosomal protein S23 is encoded by a nuclear gene and participates in mitochondrial protein translation. Mitochondrial ribosomal protein S23 overexpression has been found in many types of cancer. In this study, we explored mitochondrial ribosomal protein S23 expression in primary hepatocellular carcinoma tissues compared with matched adjacent non-tumoral liver tissues using mitochondrial ribosomal protein S23 messenger RNA and protein levels collected from public databases and clinical samples. Immunohistochemistry was performed to analyze the relationship between mitochondrial ribosomal protein S23 and various clinicopathological features. The results indicated that mitochondrial ribosomal protein S23 was significantly overexpressed in hepatocellular carcinoma. High mitochondrial ribosomal protein S23 expression was correlated with the tumor size and tumor-metastasis-node stage. Moreover, patients with high mitochondrial ribosomal protein S23 expression levels presented poorer survival rates. Mitochondrial ribosomal protein S23 was an independent prognostic factor for survival, especially at the early stage of hepatocellular carcinoma. In addition, the downregulation of mitochondrial ribosomal protein S23 decreased the proliferation of hepatocellular carcinoma in vitro and in vivo. In conclusion, we verified for the first time that mitochondrial ribosomal protein S23 expression was upregulated in hepatocellular carcinoma. High mitochondrial ribosomal protein S23 levels can predict poor clinical outcomes in hepatocellular carcinoma, and this protein plays a key role in tumor proliferation. Therefore, mitochondrial ribosomal protein S23 may be a potential therapeutic target for hepatocellular carcinoma.

  8. Standards for definitions and use of outcome measures for clinical effectiveness research in perioperative medicine: European Perioperative Clinical Outcome (EPCO) definitions: a statement from the ESA-ESICM joint taskforce on perioperative outcome measures.

    PubMed

    Jammer, Ib; Wickboldt, Nadine; Sander, Michael; Smith, Andrew; Schultz, Marcus J; Pelosi, Paolo; Leva, Brigitte; Rhodes, Andrew; Hoeft, Andreas; Walder, Bernhard; Chew, Michelle S; Pearse, Rupert M

    2015-02-01

    There is a need for large trials that test the clinical effectiveness of interventions in the field of perioperative medicine. Clinical outcome measures used in such trials must be robust, clearly defined and patient-relevant. Our objective was to develop standards for the use of clinical outcome measures to strengthen the methodological quality of perioperative medicine research. A literature search was conducted using PubMed and opinion leaders worldwide were invited to nominate papers that they believed the group should consider. The full texts of relevant articles were reviewed by the taskforce members and then discussed to reach a consensus on the required standards. The report was then circulated to opinion leaders for comment and review. This report describes definitions for 22 individual adverse events with a system of severity grading for each. In addition, four composite outcome measures were identified, which were designed to evaluate postoperative outcomes. The group also agreed on standards for four outcome measures for the evaluation of healthcare resource use and quality of life. Guidance for use of these outcome measures is provided, with particular emphasis on appropriate duration of follow-up. This report provides clearly defined and patient-relevant outcome measures for large clinical trials in perioperative medicine. These outcome measures may also be of use in clinical audit. This report is intended to complement and not replace other related work to improve assessment of clinical outcomes following specific surgical procedures.

  9. The assesment of follicular fluid presepsin levels in poor ovarian responder womenandits relationship with the reproductive outcomes

    PubMed Central

    Ovayolu, Ali; Özdamar, Özkan; Gün, İsmet; Arslanbuğa, Cansev Y; Kutlu, Tayfun; Tunalı, Gülden; Uluhan, Ramazan

    2015-01-01

    A considerable proportion of all women undergoing IVFrespond poorly to gonadotropin stimulation. These women are reported to be associated with increased cancellation rates and lower pregnancy rates. It has been hypothesized that poor response to ovarian stimulation is a first sign of ovarian ageing or premature ovarian failure, which might be related to altered inflammatory response in the body. We aimed to compare follicular fluid presepsin levels between poor- and normo-responder patients to ovarian stimulation, to assess its relationship with reproductive outcomes. This study included infertility patients who underwent ovulation induction with either long GnRH agonist or GnRH antagonist protocols and who subsequently underwent IVF/ICSI. Included patients were assigned to two groups according to the Bologna criteria for poor ovarian response. Group 1 and 2 consisted of normo- and poor-responder patients, respectively.The 2 groups were compared in terms of FF presepsin levels. Also, any relationship between the FF presepsin levels and fertility outcomes was assessed within the groups. The groups were compared by using student’s t-test, Mann-Whitney U test and X2 test, where appropriate. Pregnancy rates were not significantly different between the groups (22.6% and 17.6%; P=0.650, respectively). FF presepsin levels were higher in Group 1, however, the difference was not statistically significant (298.0±797.4 and 149.2±422.3; P=0.190, respectively). FF presepsin levels did not significantly differ between pregnancy positive and the pregnancy negative patients in both Group 1 (243.6±531.1 and 314.3±866.5; P=0.055, respectively) and Group 2 (112.2±79.8 and 157.1±464.3; P=0.394, respectively). Consequently, FF presepsin seems not to be a reliable marker in predicting pregnancy in both normo-responder and poor-responder infertility groups. PMID:26309683

  10. Prevalence of primary outcome changes in clinical trials registered on ClinicalTrials.gov: a cross-sectional study.

    PubMed

    Ramagopalan, Sreeram; Skingsley, Andrew P; Handunnetthi, Lahiru; Klingel, Michelle; Magnus, Daniel; Pakpoor, Julia; Goldacre, Ben

    2014-01-01

    An important principle in the good conduct of clinical trials is that a summary of the trial protocol, with a pre-defined primary outcome, should be freely available before the study commences. The clinical trials registry ClinicalTrials.gov provides one method of doing this, and once the trial is registered, any changes made to the primary outcome are documented. The objectives of this study were: to assess the proportion of registered trials on ClinicalTrials.gov that had the primary outcome changed; to assess when the primary outcome was changed in relation to the listed study start and end dates and to assess whether the primary outcome change had any relation to the study sponsor. A cross-sectional analysis of all interventional clinical trials registered on ClinicalTrials.gov as of 25 October 2012 was performed. The main outcome was any change made to the initially listed primary outcome and the time of the change in relation to the trial start and end date. Our analysis showed that 28229 of 89204 (31.7%) registered studies had their primary outcome changed.  Industry funding was associated with all primary outcome changes, odds ratio (OR)= 1.36, 95% confidence interval (CI)=1.31-1.41, p<0.001; with primary outcome changes after study start date OR=1.37, 95% CI=1.32-1.42, p<0.001; with primary outcome changes after primary completion date OR=1.84, 95% CI=1.75-1.94, p<0.001 and with primary outcome changes after study completion date OR=1.82, 95% CI=1.73-1.91, p<0.001.  Conclusions A significant proportion of interventional trials registered on ClinicalTrials.gov have their primary outcomes altered after the listed study start and completion dates. These changes are associated with funding source.

  11. Germ-line variants identified by next generation sequencing in a panel of estrogen and cancer associated genes correlate with poor clinical outcome in Lynch syndrome patients.

    PubMed

    Jóri, Balazs; Kamps, Rick; Xanthoulea, Sofia; Delvoux, Bert; Blok, Marinus J; Van de Vijver, Koen K; de Koning, Bart; Oei, Felicia Trups; Tops, Carli M; Speel, Ernst Jm; Kruitwagen, Roy F; Gomez-Garcia, Encarna B; Romano, Andrea

    2015-12-01

    The risk to develop colorectal and endometrial cancers among subjects testing positive for a pathogenic Lynch syndrome mutation varies, making the risk prediction difficult. Genetic risk modifiers alter the risk conferred by inherited Lynch syndrome mutations, and their identification can improve genetic counseling. We aimed at identifying rare genetic modifiers of the risk of Lynch syndrome endometrial cancer. A family based approach was used to assess the presence of genetic risk modifiers among 35 Lynch syndrome mutation carriers having either a poor clinical phenotype (early age of endometrial cancer diagnosis or multiple cancers) or a neutral clinical phenotype. Putative genetic risk modifiers were identified by Next Generation Sequencing among a panel of 154 genes involved in endometrial physiology and carcinogenesis. A simple pipeline, based on an allele frequency lower than 0.001 and on predicted non-conservative amino-acid substitutions returned 54 variants that were considered putative risk modifiers. The presence of two or more risk modifying variants in women carrying a pathogenic Lynch syndrome mutation was associated with a poor clinical phenotype. A gene-panel is proposed that comprehends genes that can carry variants with putative modifying effects on the risk of Lynch syndrome endometrial cancer. Validation in further studies is warranted before considering the possible use of this tool in genetic counseling.

  12. Early clinical outcomes following laparoscopic inguinal hernia repair.

    PubMed

    Tolver, Mette Astrup

    2013-07-01

    Laparoscopic inguinal hernia repair (TAPP) has gained increasing popularity because of less post-operative pain and a shorter duration of convalescence compared with open hernia repair technique (Lichtenstein). However, investigation of duration of convalescence with non-restrictive recommendations, and a procedure-specific characterization of the early clinical outcomes after TAPP was lacking. Furthermore, optimization of the post-operative period with fibrin sealant versus tacks for fixation of mesh, and the glucocorticoid dexamethasone versus placebo needed to be investigated in randomized clinical trials. The objective of this PhD thesis was to characterize the early clinical outcomes after TAPP and optimize the post-operative period. The four studies included in this thesis have investigated duration of convalescence and procedure-specific post-operative pain and other early clinical outcomes after TAPP. Furthermore, it has been shown that fibrin sealant can improve the early post-operative period compared with tacks, while dexamethasone showed no advantages apart from reduced use of antiemetics compared with placebo. Based on these findings, and the existing knowledge, 3-5 days of convalescence should be expected when 1 day of convalescence is recommended and future studies should focus on reducing intraabdominal pain after TAPP. Fibrin sealant can optimize the early clinical outcomes but the risk of hernia recurrence and chronic pain needs to be evaluated. Dexamethasone should be investigated in higher doses.

  13. Impact of non-medical switching on clinical and economic outcomes, resource utilization and medication-taking behavior: a systematic literature review.

    PubMed

    Nguyen, Elaine; Weeda, Erin R; Sobieraj, Diana M; Bookhart, Brahim K; Piech, Catherine Tak; Coleman, Craig I

    2016-07-01

    To evaluate current knowledge of the impact of non-medical switching on clinical and economic outcomes, resource utilization and medication-taking behavior. The literature was searched (Medline and Web of Science, January 2000-November 2015) to identify United States' studies evaluating ≥25 patients and measuring the impact of non-medical switching of drugs (switching to a chemically distinct but similar medication for reasons other than lack of clinical efficacy/response, side effects or poor adherence) on ≥1 clinical, economic, resource utilization or medication-taking behavior outcome. The direction of association between non-medical switching and outcomes was classified as negative or positive if a statistically significant worsening or improvement was reported, or neutral if no significant difference was observed. Twenty-nine studies contributed 96 outcomes (60.4% clinical; 21.9% resource utilization; 13.5% economic; 4.2% medication-taking behavior) within six disease categories (cardio-metabolic, immune-mediated, acid suppression, psychiatric, hormone replacement therapy and pain). The direction of association was more frequently negative (33.3%) or neutral (55.2%) than it was positive (11.5%). Stratified by outcome type, non-medical switching was negatively associated with clinical, economic, healthcare utilization and medication-taking behavior outcomes in 20.7%, 69.2%, 38.1% and 75.0% of cases, respectively; and positively in only 4.8%-17.2% of outcomes subgroups. Of 32 outcomes in patients demonstrating stable/well controlled disease, 68.8% and 31.3% had a negative and neutral direction of association. In patients without demonstrated disease stability, outcomes were negatively, neutrally and positively impacted by non-medical switching in 15.6%, 67.2% and 17.2% of 64 outcomes. Our inability to evaluate specific disease state categories and studies/outcomes received equal weight regardless of sample size or magnitude of effect. Non-medical switching

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

    PubMed

    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.

  15. The Identification of Seniors at Risk (ISAR) score to predict clinical outcomes and health service costs in older people discharged from UK acute medical units.

    PubMed

    Edmans, Judi; Bradshaw, Lucy; Gladman, John R F; Franklin, Matthew; Berdunov, Vladislav; Elliott, Rachel; Conroy, Simon P

    2013-11-01

    tools are required to identify high-risk older people in acute emergency settings so that appropriate services can be directed towards them. to evaluate whether the Identification of Seniors At Risk (ISAR) predicts the clinical outcomes and health and social services costs of older people discharged from acute medical units. an observational cohort study using receiver-operator curve analysis to compare baseline ISAR to an adverse clinical outcome at 90 days (where an adverse outcome was any of death, institutionalisation, hospital readmission, increased dependency in activities of daily living (decrease of 2 or more points on the Barthel ADL Index), reduced mental well-being (increase of 2 or more points on the 12-point General Health Questionnaire) or reduced quality of life (reduction in the EuroQol-5D) and high health and social services costs over 90 days estimated from routine electronic service records. two acute medical units in the East Midlands, UK. a total of 667 patients aged ≥70 discharged from acute medical units. an adverse outcome at 90 days was observed in 76% of participants. The ISAR was poor at predicting adverse outcomes (AUC: 0.60, 95% CI: 0.54-0.65) and fair for health and social care costs (AUC: 0.70, 95% CI: 0.59-0.81). adverse outcomes are common in older people discharged from acute medical units in the UK; the poor predictive ability of the ISAR in older people discharged from acute medical units makes it unsuitable as a sole tool in clinical decision-making.

  16. Even Four Minutes of Poor Quality of CPR Compromises Outcome in a Porcine Model of Prolonged Cardiac Arrest

    PubMed Central

    Li, Heng; Zhang, Lei; Yang, Zhengfei; Huang, Zitong; Chen, Bihua; Li, Yongqin; Yu, Tao

    2013-01-01

    Objective. Untrained bystanders usually delivered suboptimal chest compression to victims who suffered from cardiac arrest in out-of-hospital settings. We therefore investigated the hemodynamics and resuscitation outcome of initial suboptimal quality of chest compressions compared to the optimal ones in a porcine model of cardiac arrest. Methods. Fourteen Yorkshire pigs weighted 30 ± 2 kg were randomized into good and poor cardiopulmonary resuscitation (CPR) groups. Ventricular fibrillation was electrically induced and untreated for 6 mins. In good CPR group, animals received high quality manual chest compressions according to the Guidelines (25% of animal's anterior-posterior thoracic diameter) during first two minutes of CPR compared with poor (70% of the optimal depth) compressions. After that, a 120-J biphasic shock was delivered. If the animal did not acquire return of spontaneous circulation, another 2 mins of CPR and shock followed. Four minutes later, both groups received optimal CPR until total 10 mins of CPR has been finished. Results. All seven animals in good CPR group were resuscitated compared with only two in poor CPR group (P < 0.05). The delayed optimal compressions which followed 4 mins of suboptimal compressions failed to increase the lower coronary perfusion pressure of five non-survival animals in poor CPR group. Conclusions. In a porcine model of prolonged cardiac arrest, even four minutes of initial poor quality of CPR compromises the hemodynamics and survival outcome. PMID:24364028

  17. Outcomes research in cancer clinical trial cooperative groups: the RTOG model.

    PubMed

    Bruner, D W; Movsas, B; Konski, A; Roach, M; Bondy, M; Scarintino, C; Scott, C; Curran, W

    2004-08-01

    The Radiation Therapy Oncology Group (RTOG), a National Cancer Institute sponsored cancer clinical trials research cooperative, has recently formed an Outcomes Committee to assess a comprehensive array of clinical trial endpoints and factors impacting the net effect of therapy. To study outcomes in a consistent, comprehensive and coordinated manner, the RTOG Outcomes Committee developed a model to assess clinical, humanistic, and economic outcomes important in clinical trials. This paper reviews how the RTOG incorporates outcomes research into cancer clinical trials, and demonstrates utilization of the RTOG Outcomes Model to test hypotheses related to non-small-cell lung cancer (NSCLC). In this example, the clinical component of the model indicates that the addition of chemotherapy to radiotherapy (RT) improves survival but increases the risk of toxicity. The humanistic component indicates that esophagitis is the symptom impacting quality of life the greatest and may outweigh the benefits in elderly (> or =70 years) patients. The economic component of the model indicates that accounting for quality-adjusted survival, concurrent chemoRT for the treatment of NSCLC is within the range of economically acceptable recommendations. The RTOG Outcomes Model guides a comprehensive program of research that systematically measures a triad of endpoints considered important to clinical trials research.

  18. Irritability Trajectories, Cortical Thickness, and Clinical Outcomes in a Sample Enriched for Preschool Depression.

    PubMed

    Pagliaccio, David; Pine, Daniel S; Barch, Deanna M; Luby, Joan L; Leibenluft, Ellen

    2018-05-01

    Cross-sectional, longitudinal, and genetic associations exist between irritability and depression. Prior studies have examined developmental trajectories of irritability, clinical outcomes, and associations with child and familial depression. However, studies have not integrated neurobiological measures. The present study examined developmental trajectories of irritability, clinical outcomes, and cortical structure among preschoolers oversampled for depressive symptoms. Beginning at 3 to 5 years old, a sample of 271 children enriched for early depressive symptoms were assessed longitudinally by clinical interview. Latent class mixture models identified trajectories of irritability severity. Risk factors, clinical outcomes, and cortical thickness were compared across trajectory classes. Cortical thickness measures were extracted from 3 waves of magnetic resonance imaging at 7 to 12 years of age. Three trajectory classes were identified among these youth: 53.50% of children exhibited elevated irritability during preschool that decreased longitudinally, 30.26% exhibited consistently low irritability, and 16.24% exhibited consistently elevated irritability. Compared with other classes, the elevated irritability class exhibited higher rates of maternal depression, early life adversity, later psychiatric diagnoses, and functional impairment. Further, elevated baseline irritability predicted later depression beyond adversity and personal and maternal depression history. The elevated irritability class exhibited a thicker cortex in the left superior frontal and temporal gyri and the right inferior parietal lobule. Irritability manifested with specific developmental trajectories in this sample enriched for early depression. Persistently elevated irritability predicted poor psychiatric outcomes, higher risk for later depression, and decreased overall function later in development. Greater frontal, temporal, and parietal cortical thickness also was found, providing neural

  19. International Guillain-Barré Syndrome Outcome Study: protocol of a prospective observational cohort study on clinical and biological predictors of disease course and outcome in Guillain-Barré syndrome.

    PubMed

    Jacobs, Bart C; van den Berg, Bianca; Verboon, Christine; Chavada, Govindsinh; Cornblath, David R; Gorson, Kenneth C; Harbo, Thomas; Hartung, Hans-Peter; Hughes, Richard A C; Kusunoki, Susumu; van Doorn, Pieter A; Willison, Hugh J

    2017-06-01

    Guillain-Barré syndrome (GBS) is an acute polyradiculoneuropathy with a highly variable clinical presentation, course, and outcome. The factors that determine the clinical variation of GBS are poorly understood which complicates the care and treatment of individual patients. The protocol of the ongoing International GBS Outcome Study (IGOS), a prospective, observational, multicenter cohort study that aims to identify the clinical and biological determinants and predictors of disease onset, subtype, course and outcome of GBS is presented here. Patients fulfilling the diagnostic criteria for GBS, regardless of age, disease severity, variant forms, or treatment, can participate if included within 2 weeks after onset of weakness. Information about demography, preceding infections, clinical features, diagnostic findings, treatment, course, and outcome is collected. In addition, cerebrospinal fluid and serial blood samples for serum and DNA is collected at standard time points. The original aim was to include at least 1,000 patients with a follow-up of 1-3 years. Data are collected via a web-based data entry system and stored anonymously. IGOS started in May 2012 and by January 2017 included more than 1,400 participants from 143 active centers in 19 countries across 5 continents. The IGOS data/biobank is available for research projects conducted by expertise groups focusing on specific topics including epidemiology, diagnostic criteria, clinimetrics, electrophysiology, antecedent events, antibodies, genetics, prognostic modeling, treatment effects, and long-term outcome of GBS. The IGOS will help to standardize the international collection of data and biosamples for future research of GBS. © 2017 Peripheral Nerve Society.

  20. Radiological characteristics, histological features and clinical outcomes of lung cancer patients with coexistent idiopathic pulmonary fibrosis.

    PubMed

    Khan, K A; Kennedy, M P; Moore, E; Crush, L; Prendeville, S; Maher, M M; Burke, L; Henry, M T

    2015-02-01

    Despite advances in diagnosis and management, the outcomes for both lung cancer and idiopathic pulmonary fibrosis (IPF) are still unfavourable. The pathophysiology and outcomes for patients with concomitant lung cancer and IPF remains unclear. A retrospective analysis was performed of all patients presenting with concomitant IPF and lung cancer to our centre over a 3-year period. Patients with connective tissue disease, asbestos exposure, sarcoidosis, previous thoracic radiation, radiological evidence of fibrosis but no histological confirmation of lung cancer, or the use of medications known to cause pulmonary fibrosis were excluded. We describe clinical, radiological and pathological characteristics of this group. We also report the response to standardized lung cancer therapy in this cohort. Of 637 lung cancer patients, 34 were identified with concomitant IPF (5.3 %) and all were smokers. 85 % had non-small cell lung cancer, 41 % were squamous cell cancers. The majority of tumours were located in the lower lobes, peripheral and present in an area of honeycombing. Despite the fact that approximately 2/3rds of the patients had localised or locally advanced lung cancer, the outcome of therapy for lung cancer was extremely poor regardless of tumour stage or severity of IPF. At our centre, 1/20 patients with lung cancer have concomitant IPF. The majority of these tumours are small in size, peripheral in location and squamous cell carcinoma; in an area of honey combing. The outcome for concomitant lung cancer and IPF regardless of stage or therapy is poor.

  1. Implementation of a guideline-based clinical pathway of care to improve health outcomes following whiplash injury (Whiplash ImPaCT): protocol of a randomised, controlled trial.

    PubMed

    Rebbeck, Trudy; Leaver, Andrew; Bandong, Aila Nica; Kenardy, Justin; Refshauge, Kathryn; Connelly, Luke; Cameron, Ian; Mitchell, Geoffrey; Willcock, Simon; Ritchie, Carrie; Jagnoor, Jagnoor; Sterling, Michele

    2016-04-01

    Whiplash-associated disorders (WAD) are a huge worldwide health and economic burden. The propensity towards developing into chronic, disabling conditions drives the rise in health and economic costs associated with treatment, productivity loss and compulsory third party insurance claims. Current treatments fail to address the well-documented heterogeneity of WAD and often result in poor outcomes. A novel approach is to evaluate whether the care provided according to the estimated risk of poor prognosis improves health outcomes while remaining cost-effective. (1) Does a guideline-based clinical pathway of care improve health outcomes after whiplash injury compared to usual care? (2) Does risk of recovery have a differential effect on health outcomes for the clinical pathway of care? (3) Is the clinical pathway of care intervention cost-effective? (4) What are the variations in professional practice between usual care and the clinical pathway of care? Multi-centre, randomised, controlled trial conducted over two Australian states: Queensland and New South Wales. 236 people with WAD (grade I-III, within 6 weeks of injury) and their primary healthcare providers. A clinical pathway of care, with care matched to the predicted risk of poor recovery. Participants at low risk of ongoing pain and disability (hence, predicted to fully recover) will receive up to three sessions of guideline-based advice and exercise with their primary healthcare provider. Participants at medium/high risk of developing ongoing pain and disability will be referred to a specialist (defined as a practitioner with expertise in whiplash) who will conduct a more in-depth physical and psychological assessment. As a result, the specialist will liaise with the original primary healthcare provider and determine one of three further pathways of care. Usual care provided by the primary healthcare provider that is based on clinical judgment. Primary (global rating of change and neck-related disability) and

  2. Pooling of cross-cultural PRO data in multinational clinical trials: how much can poor measurement affect statistical power?

    PubMed

    Regnault, Antoine; Hamel, Jean-François; Patrick, Donald L

    2015-02-01

    Cultural differences and/or poor linguistic validation of patient-reported outcome (PRO) instruments may result in differences in the assessment of the targeted concept across languages. In the context of multinational clinical trials, these measurement differences may add noise and potentially measurement bias to treatment effect estimation. Our objective was to explore the potential effect on treatment effect estimation of the "contamination" of a cultural subgroup by a flawed PRO measurement. We ran a simulation exercise in which the distribution of the score in the overall sample was considered a mixture of two normal distributions: a standard normal distribution was assumed in a "main" subgroup and a normal distribution which differed either in mean (bias) or in variance (noise) in a "contaminated" subgroup (the subgroup with potential flaws in the PRO measurement). The observed power was compared to the expected power (i.e., the power that would have been observed if the subgroup had not been contaminated). Even if differences between the expected and observed power were small, some substantial differences were obtained (up to a 0.375 point drop in power). No situation was systematically protected against loss of power. The impact of poor PRO measurement in a cultural subgroup may induce a notable drop in the study power and consequently reduce the chance of showing an actual treatment effect. These results illustrate the importance of the efforts to optimize conceptual and linguistic equivalence of PRO measures when pooling data in international clinical trials.

  3. Effect of sports modification on clinical outcome in children and adolescent athletes with symptomatic lumbar spondylolysis.

    PubMed

    El Rassi, Georges; Takemitsu, Masakazu; Glutting, Joseph; Shah, Suken A

    2013-12-01

    This cohort study aimed to report the compliance of young athletes with nonoperative treatment and to clarify the role of sports modification on clinical outcome of symptomatic spondylolysis. This study included patients with a chief complaint of low back pain participating in regular sports activity, having spondylolysis, and being treated and followed up between 1990 and 2002 in the authors' hospital. One hundred thirty-two athletes were included in this study: 78 males and 54 females. The mean age of the patients was 13 yrs (range, 7-18 yrs). Only 56 patients (42.4%) were compliant to nonoperative treatment. Eighty-six patients (65%) stopped all sports activities for at least 3 mos, and 46 patients (35%) stopped exercising for a variable period of less than 3 mos. The grading of clinical outcome after nonoperative treatment was as follows: excellent in 48 patients (36.4%), good in 74 patients (56.1), fair in 6 patients (4.5%), and poor in 4 patients (3%). The patients who stopped sports for at least 3 mos were 16.39 times more likely to have an excellent result than those who did not stop sports. Bony healing on radiographs did not correlate with clinical outcome. Timely cessation of sports activity for 3 mos is considered an effective method of nonoperative treatment for young athletes with symptomatic lumbar spondylolysis.

  4. Waist-hip ratio and 1-year clinical outcome in patients with non-ST-elevation myocardial infarctions.

    PubMed

    Lee, Hye Won; Hong, Taek Jong; Hong, Ju Young; Choi, Jong Hyun; Kim, Bo Won; Ahn, Jinhee; Park, Jin Sup; Oh, Jun-Hyok; Choi, Jung Hyun; Lee, Han Cheol; Cha, Kwang Soo

    2016-08-01

    Obesity is a well-known cardiovascular disease risk factor. We evaluated the relationship between the waist-hip ratio (WHR), as a surrogate marker of central obesity, and clinical outcomes in patients with non-ST-segment elevation myocardial infarctions (NSTEMIs) undergoing percutaneous coronary interventions (PCIs). Between 2008 and 2010, NSTEMI patients who underwent PCI and who had available anthropometric data were divided into three groups according to their WHR tertile range. Clinical outcomes in the groups were analyzed. Increasing incidences of hypertension and diabetes mellitus were associated with increasing WHR. As the WHR increased, a disintegration of patient metabolic patterns was documented in laboratory findings. There was no difference in the 1-year mortality rates between the three groups. However, increasing 1-year major adverse cardiovascular event rates were documented as the WHR increased (13, 14.7, and 19.4% in tertile groups 1-3, respectively; P=0.005). After adjusting for confounding variables, the highest tertile group was associated with increased 1-year mortality and major adverse cardiovascular event rates compared with the lowest tertile group. These differences arose from the female subgroup, suggesting that the magnitude of the central obesity effect might be greater in female than in male patients. Central obesity, represented by WHR, was associated with poor clinical outcomes in NSTEMI patients undergoing PCI, particularly among women.

  5. Clinical phenomapping and outcomes after heart transplantation.

    PubMed

    Bakir, Maral; Jackson, Nicholas J; Han, Simon X; Bui, Alex; Chang, Eleanor; Liem, David A; Ardehali, Abbas; Ardehali, Reza; Baas, Arnold S; Press, Marcella Calfon; Cruz, Daniel; Deng, Mario C; DePasquale, Eugene C; Fonarow, Gregg C; Khuu, Tam; Kwon, Murray H; Kubak, Bernard M; Nsair, Ali; Phung, Jennifer L; Reed, Elaine F; Schaenman, Joanna M; Shemin, Richard J; Zhang, Qiuheng J; Tseng, Chi-Hong; Cadeiras, Martin

    2018-03-22

    Survival after heart transplantation (HTx) is limited by complications related to alloreactivity, immune suppression, and adverse effects of pharmacologic therapies. We hypothesize that time-dependent phenomapping of clinical and molecular data sets is a valuable approach to clinical assessments and guiding medical management to improve outcomes. We analyzed clinical, therapeutic, biomarker, and outcome data from 94 adult HTx patients and 1,557 clinical encounters performed between January 2010 and April 2013. Multivariate analyses were used to evaluate the association between immunosuppression therapy, biomarkers, and the combined clinical end point of death, allograft loss, retransplantation, and rejection. Data were analyzed by K-means clustering (K = 2) to identify patterns of similar combined immunosuppression management, and percentile slopes were computed to examine the changes in dosages over time. Findings were correlated with clinical parameters, human leucocyte antigen antibody titers, and peripheral blood mononuclear cell gene expression of the AlloMap (CareDx, Inc., Brisbane, CA) test genes. An intragraft, heart tissue gene coexpression network analysis was performed. Unsupervised cluster analysis of immunosuppressive therapies identified 2 groups, 1 characterized by a steeper immunosuppression minimization, associated with a higher likelihood for the combined end point, and the other by a less pronounced change. A time-dependent phenomap suggested that patients in the group with higher event rates had increased human leukocyte antigen class I and II antibody titers, higher expression of the FLT3 AlloMap gene, and lower expression of the MARCH8 and WDR40A AlloMap genes. Intramyocardial biomarker-related coexpression network analysis of the FLT3 gene showed an immune system-related network underlying this biomarker. Time-dependent precision phenotyping is a mechanistically insightful, data-driven approach to characterize patterns of clinical care and

  6. Serum Uric Acid Is Associated with Poor Outcome in Black Africans in the Acute Phase of Stroke

    PubMed Central

    Ayeah, Chia Mark; Ba, H.; Mbahe, Salomon

    2017-01-01

    Background Prognostic significance of serum uric acid (SUA) in acute stroke still remains controversial. Objectives To determine the prevalence of hyperuricemia and its association with outcome of stroke patients in the Douala General Hospital (DGH). Methods This was a hospital based prospective cohort study which included acute stroke patients with baseline SUA levels and 3-month poststroke follow-up data. Associations between high SUA levels and stroke outcomes were analyzed using multiple logistic regression and survival analysis (Cox regression and Kaplan-Meier). Results A total of 701 acute stroke patients were included and the prevalence of hyperuricemia was 46.6% with a mean SUA level of 68.625 ± 24 mg/l. Elevated SUA after stroke was associated with death (OR = 2.067; 95% CI: 1.449–2.950; p < 0.001) but did not predict this issue. However, an independent association between increasing SUA concentration and mortality was noted in a Cox proportional hazards regression model (adjusted HR = 1.740; 95% CI: 1.305–2.320; p < 0.001). Furthermore, hyperuricemia was an independent predictor of poor functional outcome within 3 months after stroke (OR = 2.482; 95% CI: 1.399–4.404; p = 0.002). Conclusion The prevalence of hyperuricemia in black African stroke patients is quite high and still remains a predictor of poor outcome. PMID:29082062

  7. Poor WOMAC scores in contralateral knee negatively impact TKA outcomes: data from the osteoarthritis initiative.

    PubMed

    Kahn, Timothy L; Soheili, Aydin C; Schwarzkopf, Ran

    2014-08-01

    While total knee arthroplasty (TKA) has been shown to have excellent outcomes, a significant proportion of patients experience relatively poor post-operative function. In this study, we test the hypothesis that the level of osteoarthritic symptoms in the contralateral knee at the time of TKA is associated with poorer post-operative outcomes in the operated knee. Using longitudinal cohort data from the Osteoarthritis Initiative (OAI), we included 171 patients who received a unilateral TKA. We compared pre-operative Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scores in the contralateral knee to post-operative WOMAC scores in the index knee. Pre-operative contralateral knee WOMAC scores were associated with post-operative index knee WOMAC Total scores, indicating that the health of the pre-operative contralateral knee is a significant factor in TKA outcomes. Copyright © 2014 Elsevier Inc. All rights reserved.

  8. Differential prevalence of established risk factors for poor cessation outcomes among smokers by level of social anxiety.

    PubMed

    Watson, Noreen L; Heffner, Jaimee L; McClure, Jennifer B; Mull, Kristen E; Bricker, Jonathan B

    2017-03-01

    Despite clear associations between social anxiety (SA), high prevalence of smoking, and cessation failure, little is known about factors contributing to these relationships. Moreover, the extent to which smokers with moderate SA represent an at-risk group of smokers is also unknown. This study examined the extent to which established risk factors for poor cessation (eg, sociodemographic, smoking history, mental health comorbidity) are prevalent among smokers with low, moderate, and high levels of SA. Participants (N = 2,637) were adult smokers from a web-based smoking cessation trial. Nineteen characteristics considered risk factors for poor cessation outcomes were assessed at baseline. Those associated with social anxiety were subsequently compared by SA level. Regression models indicated that 10/19 risk factors were associated with SA. Compared to smokers with low SA, those with moderate and high SA endorsed 4/10 and 10/10 risk factors as more prevalent or severe, respectively. Compared to smokers with low SA, High SA was associated with greater sociodemographic risk factors, while both moderate and high SA was associated with more severe mental health symptoms. Smokers with moderate and high levels of SA endorse more risk factors for poor cessation outcomes than those with low levels of SA, particularly mental health symptoms. These factors may help explain the differential smoking outcomes of socially anxious smokers. Results suggest that smokers with both moderate and high levels of SA would likely benefit from cessation interventions that address and consider these risk factors. (Am J Addict 2017;26:176-182). © 2017 American Academy of Addiction Psychiatry.

  9. Differential Prevalence of Established Risk Factors for Poor Cessation Outcomes among Smokers by Level of Social Anxiety

    PubMed Central

    Watson, Noreen L.; Heffner, Jaimee L.; McClure, Jennifer B.; Mull, Kristen E.; Bricker, Jonathan B.

    2017-01-01

    Background and Objectives Despite clear associations between social anxiety (SA), high prevalence of smoking, and cessation failure, little is known about factors contributing to these relationships. Moreover, the extent to which smokers with moderate SA represent an at-risk group of smokers is also unknown. This study examined the extent to which established risk factors for poor cessation (e.g., sociodemographic, smoking history, mental health comorbidity) are prevalent among smokers with low, moderate, and high levels of SA. Methods Participants (N = 2,637) were adult smokers from a web-based smoking cessation trial. Nineteen characteristics considered risk factors for poor cessation outcomes were assessed at baseline. Those associated with social anxiety were subsequently compared by SA level. Results Regression models indicated that 10/19 risk factors were associated with SA. Compared to smokers with low SA, those with moderate and high SA endorsed 4/10 and 10/10 risk factors as more prevalent or severe, respectively. Compared to smokers with low SA, High SA was associated with greater sociodemographic risk factors, while both moderate and high SA was associated with more severe mental health symptoms. Conclusions and Scientific Significance Smokers with moderate and high levels of SA endorse more risk factors for poor cessation outcomes than those with low levels of SA, particularly mental health symptoms. These factors may help explain the differential smoking outcomes of socially anxious smokers. Results suggest that smokers with both moderate and high levels of SA would likely benefit from cessation interventions that address and consider these risk factors. PMID:28191916

  10. A core outcome set for clinical trials in acute diarrhoea.

    PubMed

    Karas, Jacek; Ashkenazi, Shai; Guarino, Alfredo; Lo Vecchio, Andrea; Shamir, Raanan; Vandenplas, Yvan; Szajewska, Hania

    2015-04-01

    Core outcome sets are the baseline for what should be measured in clinical research and, thus, should serve as a guide for what should be collected and reported. The Consensus Group on Outcome Measures Made in Pediatric Enteral Nutrition Clinical Trials, established in 2012, agreed that consensus on a core set of outcomes with agreed-upon definitions that should be measured and reported in clinical trials was needed. To achieve this goal, six working groups (WGs) were setup, including WG on acute diarrhoea, whose main goal was to develop a core outcome set for trials in acute diarrhoea. The first step identified how published outcomes related to acute diarrhoea were reported. The second focused on the methodology for determining which outcomes to measure in clinical trials. The third employed a two-phase questionnaire study using the Delphi technique to define clinically important outcomes to clinicians and parents. For therapeutic studies, the five most important outcome measures were diarrhoea duration, degree of dehydration, need for hospitalisation (or duration of hospitalisation for inpatients), the proportion of patients recovered by 48 h and adverse effects. The prophylactic core outcome set included prevention of diarrhoea, prevention of dehydration, prevention of hospitalisation and adverse effects. The outcome sets for therapy and prevention can be recommended for use in future trials of patients with gastroenteritis. Their envisioned goal is to decrease study heterogeneity and to ease the comparability of studies. WG's next step is to determine how to measure the outcomes included in the core set. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

  11. Early-Life Trauma in Hospitalized Patients With Mood Disorders and Its Association With Clinical Outcomes.

    PubMed

    Parsaik, Ajay K; Abdelgawad, Noha; Chotalia, Jigar K; Lane, Scott D; Pigott, Teresa A

    2017-01-01

    The prevalence of childhood trauma and its impact on clinical outcomes in hospitalized patients with mood disorders is unknown. We studied the frequency of childhood trauma among inpatient adults with mood disorders and its association with clinical outcomes. Patients admitted to our hospital with a primary diagnosis of mood disorders completed the short form of the Early Trauma Inventory-Self-Report (ETISR-SF), the Sheehan Disability Scale, and the Clinician-Rated Dimensions of Psychosis Symptom Severity scale. A regression model adjusted for multiple comparisons was used to examine the association between scores on the ETISR-SF and clinical outcomes. Subjects were 167 patients, all of whom reported ≥1 types of childhood trauma: 90% general trauma, 75% physical abuse, 71% emotional abuse, 50% sexual abuse, and 35% all 4 types of abuse. The subtypes of abuse did not differ by sex or race. Diagnoses in the sample were bipolar disorder 56%, major depressive disorder 24%, schizoaffective disorder 14%, and substance-induced mood disorder 5%. The mean age in the sample was 35±11.5 years, 53% were male, and 64% also had substance abuse disorders. Higher scores on the ETISR-SF were associated with longer hospital stays [odds ratio (OR)=1.13; 95% confidence interval (CI), 1.05-1.22], and greater disruption of work/school life (OR=1.12; 95% CI, 1.04-1.21). There was also a trend for higher ETISR-SF scores to be associated with more severe psychotic symptoms (OR=1.13; 95% CI, 1.01-1.27) and more disruption in social (OR=1.14; 95% CI, 1.06-1.22) and family life (OR=1.09; 95% CI, 1.02-1.17). Childhood trauma was reported by all of the 167 patients, with general trauma the most common and approximately half reporting sexual abuse. Childhood trauma was associated with poor clinical outcomes. Early recognition of trauma and trauma-related therapeutic interventions may improve outcomes.

  12. Risk factors, clinical features and outcome of treatment of work related musculoskeletal disorders in on-site clinics among IT companies in India.

    PubMed

    Sharan, Deepak; Ajeesh, P S; Rameshkumar, R; Jose, Jeena

    2012-01-01

    Workrelated musculoskeletal disorders among the IT professional is a common area of concern worldwide. This study was taken up to analyze the prevalence of risk factors, clinical features and outcome of treatment in onsite clinics in vaious information technology companies in India. Result revealed poor office ergonomics (54%), lack of keyboard tray (25%), lack of mouse tray (35%), lack of foot rest (60%), improper monitor height (80%) were the major self reported risk factors. Major identified MSD were Myofascial Pain Syndrome (49.20%), Thoracic outlet syndrome (25.02%), Fibromyalgia syndrome (8.5%). Majorly affected body regions were neck (64.9%), shoulder (42.1%), lower back (56.5%) and thigh (34.2%). The results were comparable with the literature. Feedback of the participants also revealed most of the participants were well satisfied with SHARAN's protocol.

  13. Enterovirus infections in Singaporean children: an assessment of neurological manifestations and clinical outcomes.

    PubMed

    Thong, Wen Yi; Han, Audrey; Wang, S J Furene; Lin, Jeremy; Isa, Mas Suhaila; Koay, Evelyn Siew Chuan; Tay, Stacey Kiat-Hong

    2017-04-01

    Enterovirus infections in childhood can be associated with significant neurological morbidity. This study aimed to describe the prevalence and range of neurological manifestations, determine the clinical characteristics and assess differences in clinical outcomes for Singaporean children diagnosed with enterovirus infections. In this single-centre, case-control study, clinical data was collected retrospectively from patients admitted to National University Hospital, Singapore, from August 2007 to October 2011 and diagnosed with enterovirus infection, based on the enterovirus polymerase chain reaction test, or cultures from throat and rectal swabs or cerebrospinal fluid samples. The occurrence of neurological manifestations was reviewed and clinical outcomes were assessed. A total of 48 patients (age range: six days-17.8 years) were included in the study. Neurological manifestations were seen in 75.0% of patients, 63.9% of whom presented with aseptic meningitis. Other neurological manifestations included encephalitis, acute cerebellitis, transverse myelitis and autonomic dysfunction. The incidence of neurological manifestations was significantly higher in patients aged > 1 year as compared to younger patients (p = 0.043). In patients without neurological manifestations, a significantly higher proportion presented with hand, foot and mouth disease and poor feeding. Long-term neurological sequelae were seen in 16.7% of patients with neurological manifestations. A wide spectrum of neurological manifestations resulting in a relatively low incidence of long-term neurological sequelae was observed in our study of Singaporean children with enterovirus infections. As some of these neurological morbidities were severe, careful evaluation of children with neurological involvement is therefore necessary. Copyright: © Singapore Medical Association

  14. Clinical Risk Index for Babies score for the prediction of neurodevelopmental outcomes at 3 years of age in infants of very low birthweight.

    PubMed

    Lodha, Abhay; Sauvé, Reg; Chen, Sophie; Tang, Selphee; Christianson, Heather

    2009-11-01

    In this study, we evaluated the Clinical Risk Index for Babies - revised (CRIB-II) score as a predictor of long-term neurodevelopmental outcomes in preterm infants at 36 months' corrected age. CRIB-II scores, which include birthweight, gestational age, sex, admission temperature, and base excess, were recorded prospectively on all infants weighing 1250g or less admitted to the neonatal intensive care unit (NICU). The sensitivity and specificity of CRIB-II scores to predict poor outcomes were examined using receiver operating characteristic curves, and predictive accuracy was assessed using the area under the curve (AUC), based on the observed values entered on a continuous scale. Poor outcomes were defined as death or major neurodevelopmental disability (cerebral palsy, neurosensory hearing loss requiring amplification, legal blindness, severe seizure disorder, or cognitive score >2SD below the mean for adjusted age determined by clinical neurological examination and on the Wechsler Preschool and Primary Scale of Intelligence, Bayley Scales of Infant Development, or revised Leiter International Performance Scale). Of the 180 infants admitted to the NICU, 155 survived. Complete follow-up data were available for 107 children. The male:female ratio was 50:57 (47-53%), median birthweight was 930g (range 511-1250g), and median gestational age was 27 weeks (range 23-32wks). Major neurodevelopmental impairment was observed in 11.2% of participants. In a regression model, the CRIB-II score was significantly correlated with long-term neurodevelopmental outcomes. It predicted major neurodevelopmental impairment (odds ratio [OR] 1.57, bootstrap 95% confidence interval [CI] 1.26-3.01; AUC 0.84) and poor outcome (OR 1.46; bootstrap 95% CI 1.31-1.71, AUC 0.82) at 36 months' corrected age. CRIB-II scores of 13 or more in the first hour of life can reliably predict major neurodevelopmental impairment at 36 months' corrected age (sensitivity 83%; specificity 84%).

  15. Clinical outcome and complications of thoracic and pelvic limb stump and socket prostheses.

    PubMed

    Phillips, Andrew; Kulendra, Elvin; Bishop, Edith; Monk, Michelle; Parsons, Kevin; House, Arthur

    2017-07-20

    To describe the use, quality of life, compliance, complications, and outcome of animals fitted with stump socket prostheses. Medical records of dogs fitted with a stump socket prosthesis were reviewed. Functional outcome, quality of life and complications were retrospectively assessed from an owner questionnaire. Thirteen stump socket prostheses (12 dogs) were fitted for a variety of reasons including trauma, congenital abnormalities, and neoplasia. Eight dogs had a good outcome overall and four a poor outcome. Quality of life (QOL) remained good or excellent in 10/12 dogs. Nine complications were seen in 7/12 dogs, most were manageable; surgical wound complications (n = 2) and pressures sores (n = 4) were the most frequently encountered. One dog suffered multiple complications. Thoracic and pelvic limb stump socket prostheses had a similar complication rate, however all animals with a poor outcome had a thoracic limb stump socket prosthesis; two were small breed dogs (under 10 kg) and two had bilateral thoracic limb abnormalities. Stump socket prostheses are feasible and versatile in animals. In correctly selected cases, good to excellent outcomes are possible. However, complications are frequent but often manageable. Further investigations are required into the risk factors for poor outcomes and prospective studies are required to assess changes in biomechanics, function, and QOL before and after fitting of a stump socket prosthesis. Until further evidence is available, careful consideration should be given before fitting bilateral thoracic limb stump socket prostheses or thoracic limb stump socket prostheses to small breed dogs.

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

    PubMed

    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. Copyright © 2016 The Authors. Published by Elsevier Ltd.. All rights reserved.

  17. Predictors of poor outcomes in patients with wild mushroom-induced acute liver injury.

    PubMed

    Kim, Taerim; Lee, Danbi; Lee, Jae Ho; Lee, Yoon-Seon; Oh, Bum Jin; Lim, Kyoung Soo; Kim, Won Young

    2017-02-21

    To identify early predictive markers of poor outcomes in patients with acute liver injury from wild mushroom intoxication. This observational, retrospective record review involved adults aged ≥ 18 years admitted to emergency department with mushroom intoxication from January 2005 to December 2015. The diagnosis of mushroom intoxication was based on the following: (1) a positive history of recent wild mushroom intake (either raw or cooked); (2) the onset of gastrointestinal symptoms, such as watery diarrhea, vomiting, and/or abdominal pain, after ingestion; and (3) the exclusion of other possible causes of acute liver injury. Acute liver injury was defined by a > 5-fold elevation of liver enzymes or moderate coagulopathy [international normalized ratio (INR) > 2.0]. Clinical and laboratory findings were compared in survivors and non-survivors. Of 93 patients with mushroom intoxication, 23, 11 men (47.8%) and 12 women (52.2%), of median age 61 years, developed acute liver injury. The overall in-hospital mortality rate was 43.5% (10/23). Among the laboratory variables, mean serum alkaline phosphatase (73.38 ± 10.89 mg/dL vs 180.40 ± 65.39 mg/dL, P < 0.01), total bilirubin (2.312 ± 1.16 mg/dL vs 7.16 ± 2.94 mg/dL, P < 0.01) concentrations and indirect/direct bilirubin (2.45 ± 1.39 mg/dL vs 0.99 ± 0.45 mg/dL, P < 0.01) ratio as well as prothrombin time (1.88 ± 0.83 mg/dL vs 10.43 ± 4.81 mg/dL, P < 0.01), and activated partial thromboplastin time (aPTT; 32.48 ± 7.64 s vs 72.58 ± 41.29 s, P = 0.01), were significantly higher in non-survivors than in survivors. Logistic regression analysis showed that total bilirubin concentration (OR = 3.58, 95%CI: 1.25-10.22), indirect/direct bilirubin ratio (OR = 0.14, 95%CI: 0.02-0.94) and aPTT (OR = 1.30, 95%CI: 1.04-1.63) were significantly associated with mortality. All patients with total bilirubin > 5 mg/dL or aPTT > 50 s on day 3 died. Monitoring of bilirubin concentrations and aPTT may help in predicting clinical

  18. Poor early childhood outcomes attributable to maternal depression in Mexican women.

    PubMed

    de Castro, Filipa; Place, Jean Marie; Villalobos, Aremis; Rojas, Rosalba; Barrientos, Tonatiuh; Frongillo, Edward A

    2017-08-01

    We aimed to estimate the population fraction of poor early child health and developmental outcomes attributable to maternal depressive symptoms (DS) contrasting it between low- and middle/high-income households. We used a nationally representative probabilistic sample of 4240 children younger than 5 years old and their mothers, derived from the Mexican National Health and Nutrition Survey Data (ENSANUT 2012). Complex survey design, sampling, and analytic weights were taken into account in analyses. DS was measured by CESD-7. Child outcomes were as follows: breastfeeding, attending well-child check-ups, respiratory disease, diarrhea and general health problems, immunization, accidents, growth, obesity, and food insecurity. Prevalence of DS among mothers was 21.36%. In low-SES households, DS was associated with higher risk of never being breastfed (RR = 1.77; p < .05), health problems (RR = 1.37; p < .05), acute respiratory disease (RR = 1.51; p < .05), accidents requiring child hospitalization (RR = 2.16; p < .01), and moderate or severe food insecurity (RR = 1.58; p < .001). In medium- or high-SES households, DS was associated with higher risk of never attending a developmental check-up (RR = 2.14; p < .05) and moderate or severe food insecurity (RR = 1.75; p < .01). Population risks attributable to DS ranged from 2.30 to 17.45%. Prevention of DS could lead to reduction of problematic early childhood outcomes in both low and medium/high SES.

  19. Clinically Non-Metastatic Renal Cell Carcinoma With Sarcomatoid Dedifferentiation: Natural History and Outcomes after Surgical Resection with Curative Intent

    PubMed Central

    Merrill, Megan M.; Wood, Christopher G.; Tannir, Nizar M.; Slack, Rebecca S.; Babaian, Kara N.; Jonasch, Eric; Pagliaro, Lance C.; Compton, Zachary; Tamboli, Pheroze; Sircar, Kanishka; Pisters, Louis L.; Matin, Surena F.; Karam, Jose A.

    2015-01-01

    Purpose Renal cell carcinoma with sarcomatoid dedifferentiation (sRCC) is an aggressive malignancy associated with a poor prognosis. While existing literature focuses on patients presenting with metastatic disease, characteristics and outcomes for patients with localized disease are not well described. We aimed to evaluate post-nephrectomy characteristics, outcomes, and predictors of survival in patients with sRCC who presented with clinically localized disease. Patients and Methods An IRB-approved review from 1986–2011 identified 77 patients who presented with clinically localized disease, underwent nephrectomy and had sRCC in their primary kidney tumor. Clinical and pathologic variables were captured for each patient. Overall survival (OS) and recurrence-free survival (RFS) were calculated for all patients and those who had no evidence of disease (NED) following nephrectomy, respectively. Comparisons were made with categorical groupings in proportional hazards regression models for univariable and multivariable analyses. Results OS for the entire cohort (N=77) at 2 years was 50%. A total of 56 (77%) patients of the 73 who were NED following nephrectomy experienced a recurrence, with a median time to recurrence of 26.2 months. On multivariable analysis, tumor stage, pathologically positive lymph nodes, and year of nephrectomy were significant predictors of both OS and RFS. Limitations include the retrospective nature of this study and relatively small sample size. Conclusions Long-term survival for patients with sRCC, even in clinically localized disease is poor. Aggressive surveillance of those who are NED following nephrectomy is essential and further prospective studies evaluating the benefit of adjuvant systemic therapies in this cohort are warranted. PMID:25700975

  20. Vemurafenib in BRAF-mutant metastatic melanoma patients in real-world clinical practice: prognostic factors associated with clinical outcomes.

    PubMed

    Schouwenburg, Maartje G; Jochems, Anouk; Leeneman, Brenda; Franken, Margreet G; van den Eertwegh, Alfons J M; Haanen, John B A G; van Zeijl, Michiel C T; Aarts, Maureen J; van Akkooi, Alexander C J; van den Berkmortel, Franchette W P J; Blokx, Willeke A M; de Groot, Jan Willem B; Hospers, Geke A P; Kapiteijn, Ellen; Koornstra, Rutger H; Kruit, Wim H; Louwman, Marieke W J; Piersma, Djura; van Rijn, Rozemarijn S; Suijkerbuijk, Karijn P M; Ten Tije, Albert J; Vreugdenhil, Gerard; Wouters, Michel W J M; van der Hoeven, Jacobus J M

    2018-08-01

    The aim of this population-based study was to identify the factors associated with clinical outcomes in vemurafenib-treated patients and to evaluate outcomes across subgroups of patients with different risk profiles. Data were retrieved from the Dutch Melanoma Treatment Registry. Time to next treatment (TTNT) and overall survival (OS) of all metastatic melanoma patients who received vemurafenib between 2012 and 2015 were assessed using Kaplan-Meier estimates. A risk score was developed on the basis of all prognostic factors associated with TTNT and OS derived from multivariable Cox regression analyses. Patients were stratified according to the presence of prognostic risk factors by counting the number of factors, ranging from 0 to 6. A total of 626 patients received vemurafenib with a median follow-up of 35.8 months. The median TTNT and OS were 4.7 months [95% confidence intervals (CI): 4.4-5.1] and 7.3 months (95% CI: 6.6-8.0). The strongest prognostic factors were serum lactate dehydrogenase (LDH) level, Eastern Cooperative Oncology Group performance score, number of organ sites involved and brain metastases. Patients with a favourable risk profile (no risk factors) had a median TTNT and OS of 7.1 (95% CI: 5.8-8.5) and 15.4 months (95% CI: 10.0-20.9). The median OS more than halved for patients with greater than or equal to 2 risk factors compared with patients with no risk factors. The clinical outcomes of vemurafenib in metastatic melanoma patients with a favourable risk profile are comparable with the results of the trials. Combining prognostic factors into a risk score could be valuable to stratify patients into favourable and poor-prognosis groups.

  1. The EXCITE Trial: Predicting a Clinically Meaningful Motor Activity Log Outcome

    PubMed Central

    Park, Si-Woon; Wolf, Steven L.; Blanton, Sarah; Winstein, Carolee; Nichols-Larsen, Deborah S.

    2013-01-01

    Background and Objective This study determined which baseline clinical measurements best predicted a predefined clinically meaningful outcome on the Motor Activity Log (MAL) and developed a predictive multivariate model to determine outcome after 2 weeks of constraint-induced movement therapy (CIMT) and 12 months later using the database from participants in the Extremity Constraint Induced Therapy Evaluation (EXCITE) Trial. Methods A clinically meaningful CIMT outcome was defined as achieving higher than 3 on the MAL Quality of Movement (QOM) scale. Predictive variables included baseline MAL, Wolf Motor Function Test (WMFT), the sensory and motor portion of the Fugl-Meyer Assessment (FMA), spasticity, visual perception, age, gender, type of stroke, concordance, and time after stroke. Significant predictors identified by univariate analysis were used to develop the multivariate model. Predictive equations were generated and odds ratios for predictors were calculated from the multivariate model. Results Pretreatment motor function measured by MAL QOM, WMFT, and FMA were significantly associated with outcome immediately after CIMT. Pretreatment MAL QOM, WMFT, proprioception, and age were significantly associated with outcome after 12 months. Each unit of higher pretreatment MAL QOM score and each unit of faster pretreatment WMFT log mean time improved the probability of achieving a clinically meaningful outcome by 7 and 3 times at posttreatment, and 5 and 2 times after 12 months, respectively. Patients with impaired proprioception had a 20% probability of achieving a clinically meaningful outcome compared with those with intact proprioception. Conclusions Baseline clinical measures of motor and sensory function can be used to predict a clinically meaningful outcome after CIMT. PMID:18780883

  2. The EXCITE Trial: Predicting a clinically meaningful motor activity log outcome.

    PubMed

    Park, Si-Woon; Wolf, Steven L; Blanton, Sarah; Winstein, Carolee; Nichols-Larsen, Deborah S

    2008-01-01

    This study determined which baseline clinical measurements best predicted a predefined clinically meaningful outcome on the Motor Activity Log (MAL) and developed a predictive multivariate model to determine outcome after 2 weeks of constraint-induced movement therapy (CIMT) and 12 months later using the database from participants in the Extremity Constraint Induced Therapy Evaluation (EXCITE) Trial. A clinically meaningful CIMT outcome was defined as achieving higher than 3 on the MAL Quality of Movement (QOM) scale. Predictive variables included baseline MAL, Wolf Motor Function Test (WMFT), the sensory and motor portion of the Fugl-Meyer Assessment (FMA), spasticity, visual perception, age, gender, type of stroke, concordance, and time after stroke. Significant predictors identified by univariate analysis were used to develop the multivariate model. Predictive equations were generated and odds ratios for predictors were calculated from the multivariate model. Pretreatment motor function measured by MAL QOM, WMFT, and FMA were significantly associated with outcome immediately after CIMT. Pretreatment MAL QOM, WMFT, proprioception, and age were significantly associated with outcome after 12 months. Each unit of higher pretreatment MAL QOM score and each unit of faster pretreatment WMFT log mean time improved the probability of achieving a clinically meaningful outcome by 7 and 3 times at posttreatment, and 5 and 2 times after 12 months, respectively. Patients with impaired proprioception had a 20% probability of achieving a clinically meaningful outcome compared with those with intact proprioception. Baseline clinical measures of motor and sensory function can be used to predict a clinically meaningful outcome after CIMT.

  3. Outcome definitions and clinical predictors influence pharmacogenetic associations between HTR3A gene polymorphisms and response to clozapine in patients with schizophrenia.

    PubMed

    Rajkumar, A P; Poonkuzhali, B; Kuruvilla, A; Srivastava, A; Jacob, M; Jacob, K S

    2012-12-01

    Pharmacogenetics of schizophrenia has not yet delivered anticipated clinical dividends. Clinical heterogeneity of schizophrenia contributes to the poor replication of the findings of pharmacogenetic association studies. Functionally important HTR3A gene single-nucleotide polymorphisms (SNPs) were reported to be associated with response to clozapine. The aim of this study was to investigate how the association between HTR3A gene SNP and response to clozapine is influenced by various clinical predictors and by differing outcome definitions in patients with treatment-resistant schizophrenia (TRS). We recruited 101 consecutive patients with TRS, on stable doses of clozapine, and evaluated their HTR3A gene SNP (rs1062613 and rs2276302), psychopathology, and serum clozapine levels. We assessed their socio-demographic and clinical profiles, premorbid adjustment, traumatic events, cognition, and disability using standard assessment schedules. We evaluated their response to clozapine, by employing six differing outcome definitions. We employed appropriate multivariate statistics to calculate allelic and genotypic association, accounting for the effects of various clinical variables. T allele of rs1062613 and G allele of rs2276302 were significantly associated with good clinical response to clozapine (p = 0.02). However, varying outcome definitions make these associations inconsistent. rs1062613 and rs2276302 could explain only 13.8 % variability in the responses to clozapine, while combined clinical predictors and HTR3A pharmacogenetic association model could explain 38 % variability. We demonstrated that the results of pharmacogenetic studies in schizophrenia depend heavily on their outcome definitions and that combined clinical and pharmacogenetic models have better predictive values. Future pharmacogenetic studies should employ multiple outcome definitions and should evaluate associated clinical variables.

  4. Duration of untreated illness in panic disorder: a poor outcome risk factor?

    PubMed

    Altamura, A Carlo; Santini, Annalisa; Salvadori, Daniele; Mundo, Emanuela

    2005-12-01

    The aim of this naturalistic study was to evaluate the impact of the duration of untreated illness (DUI) on the outcome and treatment response of panic disorder (PD). Ninety-six outpatients with PD who underwent an 8-week open-label treatment with serotonergic antidepressants were subdivided into two subgroups: those with DUI 1 year. The main baseline demographic and clinical variables were calculated and compared between the two subgroups of patients (chi-square test or t-test for independent samples). The effect of the antipanic medication was evaluated by analysis of variance with repeated measures considering Hamilton Rating Scale for Anxiety, Clinical Global Impression rating scores, and the number of panic attacks/week as the dependent variables (outcome measures), while the subgroups were the independent ones. Comorbidity with onset later than PD was also considered. There were no differences between patients with DUI 1 year with respect to the outcome measures considered. However, patients with DUI > 1 year (N = 64) had a higher frequency of comorbid major depressive disorder (MDD) with onset later than PD (p = 0.006). Results from this study suggest that the DUI may be a predictor of the development of comorbid MDD in PD. Further investigations on larger samples and with longer follow-up are warranted.

  5. Duration of untreated illness in panic disorder: a poor outcome risk factor?

    PubMed Central

    Altamura, A Carlo; Santini, Annalisa; Salvadori, Daniele; Mundo, Emanuela

    2005-01-01

    Objective The aim of this naturalistic study was to evaluate the impact of the duration of untreated illness (DUI) on the outcome and treatment response of panic disorder (PD). Methods Ninety-six outpatients with PD who underwent an 8-week open-label treatment with serotonergic antidepressants were subdivided into two subgroups: those with DUI ≤ 1 year and those with DUI > 1 year. The main baseline demographic and clinical variables were calculated and compared between the two subgroups of patients (chi-square test or t-test for independent samples). The effect of the antipanic medication was evaluated by analysis of variance with repeated measures considering Hamilton Rating Scale for Anxiety, Clinical Global Impression rating scores, and the number of panic attacks/week as the dependent variables (outcome measures), while the subgroups were the independent ones. Comorbidity with onset later than PD was also considered. Results There were no differences between patients with DUI ≤ 1 year and patients with DUI > 1 year with respect to the outcome measures considered. However, patients with DUI > 1 year (N = 64) had a higher frequency of comorbid major depressive disorder (MDD) with onset later than PD (p = 0.006). Conclusions Results from this study suggest that the DUI may be a predictor of the development of comorbid MDD in PD. Further investigations on larger samples and with longer follow-up are warranted. PMID:18568114

  6. Clinical and angiographic outcome after endovascular management of giant intracranial aneurysms.

    PubMed

    Jahromi, Babak S; Mocco, J; Bang, Jee A; Gologorsky, Yakov; Siddiqui, Adnan H; Horowitz, Michael B; Hopkins, L Nelson; Levy, Elad I

    2008-10-01

    Giant (>or=25 mm) intracranial aneurysms (IA) have an extremely poor natural history and continue to confound modern techniques for management. Currently, there is a dearth of large series examining endovascular treatment of giant IAs only. We reviewed long-term clinical and radiological outcome from a series of 39 consecutive giant IAs treated with endovascular repair in 38 patients at 2 tertiary referral centers. Data were evaluated in 3 ways: on a per-treatment session basis for each aneurysm, at 30 days after each patient's final treatment, and at the last known follow-up examination. Ten (26%) aneurysms were ruptured. At the last angiographic follow-up examination (21.5 +/- 22.9 months), 95% or higher and 100% occlusion rates were documented in 64 and 36% of aneurysms, respectively, with parent vessel preservation maintained in 74%. Stents were required in 25 aneurysms. Twenty percent of treatment sessions resulted in permanent morbidity, and death within 30 days occurred after 8% of treatment sessions. On average, 1.9 +/- 1.1 sessions were required to treat each aneurysm, with a resulting cumulative per-patient mortality of 16% and morbidity of 32%. At the last known clinical follow-up examination (mean, 24.8 +/- 24.8 months), 24 (63%) patients had Glasgow Outcome Scale scores of 4 or 5 ("good" or "excellent"), 10 patients had worsened neurological function from baseline (26% morbidity), and 11 had died (29% mortality). We present what is to our knowledge the largest series to date evaluating outcome after consecutive giant IAs treated with endovascular repair. Giant IAs carry a high risk for surgical or endovascular intervention. We hope critical and honest evaluation of treatment results will ensure continued improvement in patient care.

  7. Incidence, predictors and clinical outcomes of residual stenosis after aortic valve-in-valve.

    PubMed

    Bleiziffer, Sabine; Erlebach, Magdalena; Simonato, Matheus; Pibarot, Philippe; Webb, John; Capek, Lukas; Windecker, Stephan; George, Isaac; Sinning, Jan-Malte; Horlick, Eric; Napodano, Massimo; Holzhey, David M; Petursson, Petur; Cerillo, Alfredo; Bonaros, Nikolaos; Ferrari, Enrico; Cohen, Mauricio G; Baquero, Giselle; Jones, Tara L; Kalra, Ankur; Reardon, Michael J; Chhatriwalla, Adnan; Gama Ribeiro, Vasco; Alnasser, Sami; Van Mieghem, Nicolas M; Rustenbach, Christian Jörg; Schofer, Joachim; Garcia, Santiago; Zeus, Tobias; Champagnac, Didier; Bekeredjian, Raffi; Kornowski, Ran; Lange, Rüdiger; Dvir, Danny

    2018-05-01

    We aimed to analyse the incidence of prosthesis-patient mismatch (PPM) and elevated gradients after aortic valve in valve (ViV), and to evaluate predictors and associations with clinical outcomes of this adverse event. A total of 910 aortic ViV patients were investigated. Elevated residual gradients were defined as ≥20 mm Hg. PPM was identified based on the indexed effective orifice area (EOA), measured by echocardiography, and patient body mass index (BMI). Moderate and severe PPM (cases) were defined by European Association of Cardiovascular Imaging (EACVI) criteria and compared with patients without PPM (controls). Moderate or greater PPM was found in 61% of the patients, and severe in 24.6%. Elevated residual gradients were found in 27.9%. Independent risk factors for the occurrence of lower indexed EOA and therefore severe PPM were higher gradients of the failed bioprosthesis at baseline (unstandardised beta -0.023; 95% CI -0.032 to -0.014; P<0.001), a stented (vs a stentless) surgical bioprosthesis (unstandardised beta -0.11; 95% CI -0.161 to -0.071; P<0.001), higher BMI (unstandardised beta -0.01; 95% CI -0.013 to -0.007; P<0.001) and implantation of a SAPIEN/SAPIEN XT/SAPIEN 3 transcatheter device (unstandardised beta -0.064; 95% CI -0.095 to -0.032; P<0.001). Neither severe PPM nor elevated gradients had an association with VARC II-defined outcomes or 1-year survival (90.9% severe vs 91.5% moderate vs 89.3% none, P=0.44). Severe PPM and elevated gradients after aortic ViV are very common but were not associated with short-term survival and clinical outcomes. The long-term effect of poor post-ViV haemodynamics on clinical outcomes requires further evaluation. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

  8. Negative Consequences of Poor Driving Outcomes Reported by Adolescents With and Without ADHD.

    PubMed

    Narad, Megan E; Garner, Annie A; Antonini, Tanya N; Kingery, Kathleen M; Tamm, Leanne; Calhoun, Heather R; Epstein, Jeffery N

    2015-03-16

    Although adolescents with ADHD report less driving experience, a greater proportion of adolescents with ADHD report receiving at least one ticket; however, no study has examined the severity of infractions committed by adolescent drivers with ADHD. A total of 61 adolescents (28 ADHD, 33 controls) aged 16 to 17 with a valid driver's license completed a self-report Driving History Questionnaire (DHQ), which asked about months of driving experience, negative driving outcomes, and severity of consequences. A greater proportion of adolescents with ADHD reported receiving fines, points on their driver's license, and remedial driving class. Furthermore, adolescents with ADHD reported attending a greater number of hours in remedial driving class, and a greater expense associated with fines. Importantly, ADHD-related negative driving outcomes manifest early in driving careers. Furthermore, increased negative consequences of poor and/or risky driving among adolescents with ADHD were evident despite having fewer months of independent driving. © 2015 SAGE Publications.

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

    PubMed Central

    2012-01-01

    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. PMID:22867278

  10. Impact of individual clinical outcomes on trial participants' perspectives on enrollment in emergency research without consent.

    PubMed

    Whitesides, Louisa W; Baren, Jill M; Biros, Michelle H; Fleischman, Ross J; Govindarajan, Prasanthi R; Jones, Elizabeth B; Pancioli, Arthur M; Pentz, Rebecca D; Scicluna, Victoria M; Wright, David W; Dickert, Neal W

    2017-04-01

    trial were available for all 74 patients represented in the Patients' Experiences in Emergency Research-Progesterone for the Treatment of Traumatic Brain Injury study (including 46 patients for whom the surrogate was interviewed due to the patient's cognitive status or death). No significant difference was observed regarding acceptance of general trial inclusion or acceptance of general exception from informed consent enrollment between participants with favorable neurological outcomes and those with unfavorable outcomes relative to initial injury. Agreement with personal enrollment in Progesterone for the Treatment of Traumatic Brain Injury trial under exception from informed consent, however, was significantly higher among participants with favorable outcomes compared to those with unfavorable outcomes (89% vs 59%, p = 0.003). There was also a statistically significant relationship between more severe initial injury and increased acceptance of personal exception from informed consent enrollment ( p = 0.040) or general exception from informed consent use ( p = 0.034) in Progesterone for the Treatment of Traumatic Brain Injury trial. Many individuals referenced personal experience as a basis for their attitudes, but these references were not used to support negative views. Patients and surrogates of patients with unfavorable clinical outcomes were somewhat less accepting of their own inclusion in the Progesterone for the Treatment of Traumatic Brain Injury trial under exception from informed consent than were patients or surrogates of patients with favorable clinical outcomes. These findings suggest a need to identify optimal strategies for communicating with patients and their surrogates regarding exception from informed consent enrollment when clinical outcomes are poor.

  11. Association of health literacy with type 2 diabetes mellitus self-management and clinical outcomes within the primary care setting of Iran.

    PubMed

    Niknami, Marzieh; Mirbalouchzehi, Ali; Zareban, Iraj; Kalkalinia, Elahibakhsh; Rikhtgarha, Gasem; Hosseinzadeh, Hassan

    2018-04-06

    This study explores the potential association of health literacy with type 2 diabetes mellitus (T2DM) self-management and clinical outcomes in the primary care setting of Iran. A total of 347 T2DM patients, mostly female (52.4%), 50 years old or younger (63.1%), unemployed (53.6%) and rural residents (55.6%) participated in this study. Most of the respondents had type 2 diabetes mellitus (T2DM) for 2-5 years (63.1%) and did not receive any T2DM education (52.2%). Approximately 19.0% were hospitalised due to uncontrolled T2DM. Participants mainly found managing T2DM self-management behaviours difficult. Approximately half of the participants had poor fasting blood sugar (FBS) (47.0%) and haemoglobin A1c (HbA1c) (59.4%) control and were overweight or obese (77.6%). The level of health literacy was poor and most of the participants had difficulties reading hospital materials (66.0%), understanding medical materials (62.5%) and engaging in medical conversations (63.7%). Health literacy could predict 22.5% variance in difficulty of T2DM self-management and 3.8-23.3% variance in T2DM clinical outcomes after controlling for sociodemographic factors. Participants with higher health literacy were more likely to find managing T2DM less challenging and their clinical outcomes were within the normal range. This implies that interventions targeting patient's health literacy can be a promising tool for addressing the burden of T2DM.

  12. Recommendations for Self-Report Outcome Measures in Vulvodynia Clinical Trials.

    PubMed

    Pukall, Caroline F; Bergeron, Sophie; Brown, Candace; Bachmann, Gloria; Wesselmann, Ursula

    2017-08-01

    Vulvodynia (idiopathic chronic vulvar pain) is a prevalent condition associated with significant and negative impacts in many areas of function. Despite the increased research interest in vulvodynia in recent years, recommendations for outcome measures for use in clinical trials are missing. The purpose of this paper, therefore, was to provide recommendations for outcome measures for vulvodynia clinical trials so that consistent measures are used across trials to facilitate between-study comparisons and the conduct of large multicenter trials, and to improve measurement of the multiple dimensions of vulvodynia. Given that provoked vestibulodynia (PVD)-characterized by provoked pain localized to the vaginal opening-is the most common subtype of vulvodynia and the current main focus of clinical trials, this paper focused on recommended outcome measures in PVD clinical trials. The framework used to guide the selection of outcome measures was based on the one proposed by the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT). The IMMPACT framework provided a well-suited guideline for outcome measure recommendations in PVD clinical trials. However, given the provoked presentation of PVD and the significant impact it has on sexuality, modifications to some of the IMMPACT recommendations were made and specific additional measures were suggested. Measures that are specific to vulvovaginal pain are ideal for adoption in PVD clinical trials, and many such measures currently exist that allow the relevant IMMPACT domains to be captured.

  13. Funding source and primary outcome changes in clinical trials registered on ClinicalTrials.gov are associated with the reporting of a statistically significant primary outcome: a cross-sectional study.

    PubMed

    Ramagopalan, Sreeram V; Skingsley, Andrew P; Handunnetthi, Lahiru; Magnus, Daniel; Klingel, Michelle; Pakpoor, Julia; Goldacre, Ben

    2015-01-01

    We and others have shown a significant proportion of interventional trials registered on ClinicalTrials.gov have their primary outcomes altered after the listed study start and completion dates. The objectives of this study were to investigate whether changes made to primary outcomes are associated with the likelihood of reporting a statistically significant primary outcome on ClinicalTrials.gov. A cross-sectional analysis of all interventional clinical trials registered on ClinicalTrials.gov as of 20 November 2014 was performed. The main outcome was any change made to the initially listed primary outcome and the time of the change in relation to the trial start and end date. 13,238 completed interventional trials were registered with ClinicalTrials.gov that also had study results posted on the website. 2555 (19.3%) had one or more statistically significant primary outcomes. Statistical analysis showed that registration year, funding source and primary outcome change after trial completion were associated with reporting a statistically significant primary outcome .  Funding source and primary outcome change after trial completion are associated with a statistically significant primary outcome report on clinicaltrials.gov.

  14. Physiotherapy-led arthroplasty review clinic: a preliminary outcomes analysis.

    PubMed

    Large, Kate E; Page, Carolyn J; Brock, Kim; Dowsey, Michelle M; Choong, Peter F M

    2014-11-01

    With the rising demand for Orthopaedics in the healthcare sector, service delivery innovations need to be explored to accommodate the increasing workload. Senior Musculoskeletal Physiotherapists have the specialised skills in the assessment of musculoskeletal conditions to determine the impact of surgery on patient outcomes. The aim of the present study was to compare outcomes between a physiotherapy-led arthroplasty review clinic (PT clinic) and the traditional model of orthopaedic surgeon review (OS clinic) after hip and knee replacement. This study was a retrospective case-controlled audit using a comprehensive database. Twenty-four patients who had a hip arthroplasty and 52 patients who had a knee arthroplasty were reviewed solely by the PT clinic at 3, 6 and 12 months after surgical reviews. These patients were matched 1:2 against patients seen only by the OS clinic. The outcome measures included International Knee Score (IKS), Harris Hip Score (HHS) and the Short Form (SF)-12. There were no significant differences in HHS or SF-12 scores for patients after hip arthroplasty. Significant differences for knee arthroplasty were observed favouring the PT clinic; IKS, PT clinic 147.6 (37.07), OS clinic 135.4 (35.68), P≤0.01, and physical component of the SF-12, PT clinic 41.98 (10.45), OS clinic 37.20 (10.44), P<0.01. Implementation of a physiotherapy-led arthroplasty review clinic appears to be a safe and effective service alternative to reviews conducted by orthopaedic surgeons. WHAT IS KNOWN ABOUT THE TOPIC?: Osteoarthritis (OA) is a leading cause of musculoskeletal pain and disability and the burden of the disease is rapidly increasing. Joint arthroplasty surgery is the mainstay of treatment for people with end-stage OA; it is a high-cost, high-volume procedure that dominates surgical wait lists around Australia. Long-term follow up is encouraged by the Arthroplasty Society of Australia and endorsed by the Australian Orthopaedics Association, but it is

  15. Pharmacists' interventions on clinical asthma outcomes: a systematic review.

    PubMed

    Garcia-Cardenas, Victoria; Armour, Carol; Benrimoj, Shalom I; Martinez-Martinez, Fernando; Rotta, Inajara; Fernandez-Llimos, Fernando

    2016-04-01

    The objective of this systematic review was to evaluate the impact of pharmacists' interventions on clinical asthma outcomes on adult patients and to identify the outcome indicators used.PubMed, Scopus, Web of Science and Scielo were searched. Studies addressing pharmacists' interventions on adult asthma patients reporting clinical asthma outcomes were incorporated.11 clinical outcomes were identified in 21 studies. 10 studies measured the impact of the intervention on asthma control. Randomised controlled trials (RCT) and non-RCTs found positive results in percentages of controlled patients and Asthma Control Questionnaire (ACQ) scores. Discordant results were found for Asthma Control Test results. Asthma severity was assessed in four studies. One RCT found a significant decrease in the percentage of severe patients; two non-RCTs found significant improvements in severity scores. 11 studies reported pulmonary function indicators, showing inconsistent results. Eight studies measured asthma symptoms; three RCTs and four non-RCTs showed significant improvements.RCTs and non-RCTs generated similar results for most outcomes. Based on the evidence generated by RCTs, pharmacists' have a positive impact on the percentage of controlled patients, ACQ scores, severity and symptoms. Future research should report using the core outcome set of indicators established for asthma (PROSPERO CRD42014007019). Copyright ©ERS 2016.

  16. Incidence of delayed seizures, delayed cerebral ischemia and poor outcome with the use of levetiracetam versus phenytoin after aneurysmal subarachnoid hemorrhage.

    PubMed

    Karamchandani, Rahul Ramesh; Fletcher, Jeffrey James; Pandey, Aditya Swarup; Rajajee, Venkatakrishna

    2014-09-01

    Current guidelines recommend against the use of phenytoin following aneurysmal subarachnoid hemorrhage (aSAH) but consider other anticonvulsants, such as levetiracetam, acceptable. Our objective was to evaluate the risk of poor functional outcomes, delayed cerebral ischemia (DCI) and delayed seizures in aSAH patients treated with levetiracetam versus phenytoin. Medical records of patients with aSAH admitted between 2005-2012 receiving anticonvulsant prophylaxis with phenytoin or levetiracetam for >72 hours were reviewed. The primary outcome measure was poor functional outcome, defined as modified Rankin Scale (mRS) score >3 at first recorded follow-up. Secondary outcomes measures included DCI and the incidence of delayed seizures. The association between the use of levetiracetam and phenytoin and the outcomes of interest was studied using logistic regression. Medical records of 564 aSAH patients were reviewed and 259 included in the analysis after application of inclusion/exclusion criteria. Phenytoin was used exclusively in 43 (17%), levetiracetam exclusively in 132 (51%) while 84 (32%) patients were switched from phenytoin to levetiracetam. Six (2%) patients had delayed seizures, 94 (36%) developed DCI and 63 (24%) had mRS score >3 at follow-up. On multivariate analysis, only modified Fisher grade and seizure before anticonvulsant administration were associated with DCI while age, Hunt-Hess grade and presence of intraparenchymal hematoma were associated with mRS score >3. Choice of anticonvulsant was not associated with any of the outcomes of interest. There was no difference in the rate of delayed seizures, DCI or poor functional outcome in patients receiving phenytoin versus levetiracetam after aSAH. The high rate of crossover from phenytoin suggests that levetiracetam may be better tolerated. Copyright © 2014 The Authors. Published by Elsevier Ltd.. All rights reserved.

  17. Early termination of cardiovascular trials as a consequence of poor accrual: analysis of ClinicalTrials.gov 2006-2015.

    PubMed

    Baldi, Ileana; Lanera, Corrado; Berchialla, Paola; Gregori, Dario

    2017-06-15

    To present a snapshot of experimental cardiovascular research with a focus on geographical and temporal patterns of early termination due to poor accrual. The Aggregate Analysis of ClinicalTrials.gov (AACT) database, reflecting ClinicalTrials.gov as of 27 March 2016. The AACT database was searched for all cardiovascular clinical trials that started from January 2006 up to December 2015. Thirteen thousand and seven hundred twenty-nine cardiovascular trials were identified. Of these, 8900 (65%) were classified as closed studies. Globally, 11% of closed trials were terminated. This proportion varied from 9.6% to 14% for trials recruiting from Europe and Americas, respectively, with a slightly decreasing trend (p=0.02) over the study period. The most common reason for trials failing to complete was poor accrual (41%). Intercontinental trials exhibited lower figures of poor accrual as the reason for their early stopping, as compared with trials recruiting in a single continent (28% vs 44%, p=0.002). Poor accrual significantly challenges the successful completion of cardiovascular clinical trials. Findings are suggestive of a positive effect of globalisation of cardiovascular clinical research on the achievement of enrolment goals within a reasonable time frame. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

  18. Biomarkers of Endothelial Activation Are Associated with Poor Outcome in Critical Illness.

    PubMed

    Mikacenic, Carmen; Hahn, William O; Price, Brenda L; Harju-Baker, Susanna; Katz, Ronit; Kain, Kevin C; Himmelfarb, Jonathan; Liles, W Conrad; Wurfel, Mark M

    2015-01-01

    Endothelial activation plays a role in organ dysfunction in the systemic inflammatory response syndrome (SIRS). Angiopoietin-1 (Ang-1) promotes vascular quiescence while angiopoietin-2 (Ang-2) mediates microvascular leak. Circulating levels of Ang-1 and Ang-2 in patients with SIRS could provide insight on risks for organ dysfunction and death distinct from inflammatory proteins. In this study, we determined if biomarkers of endothelial activation and inflammation exhibit independent associations with poor outcomes in SIRS. We studied 943 critically ill patients with SIRS admitted to an Intensive Care Unit (ICU) of an academic medical center. We measured plasma levels of endothelial markers (Ang-1, Ang-2, soluble vascular cell adhesion molecule-1 (sVCAM-1)) and inflammatory markers (interleukin-6 (IL-6), interleukin-8 (IL-8), granulocyte-colony stimulating factor (G-CSF), soluble tumor necrosis factor receptor-1 (sTNFR-1)) within 24 hours of enrollment. We tested for associations between each marker and 28 day mortality, shock, and day 3 sequential organ failure assessment (SOFA) score. For 28 day mortality, we performed sensitivity analysis for those subjects with sepsis and those with sterile inflammation. We used multivariate models to adjust for clinical covariates and determine if associations identified with endothelial activation markers were independent of those observed with inflammatory markers. Higher levels of all biomarkers were associated with increased 28 day mortality except levels of Ang-1 which were associated with lower mortality. After adjustment for comorbidities and sTNFR-1 concentration, a doubling of Ang-1 concentration was associated with lower 28 day mortality (Odds ratio (OR) = 0.81; p<0.01), shock (OR = 0.82; p<0.001), and SOFA score (β = -0.50; p<0.001), while Ang-2 concentration was associated with increased mortality (OR = 1.55; p<0.001), shock (OR = 1.51; p<0.001), and SOFA score (β = +0.63; p<0.001). sVCAM-1 was not independently

  19. Corifollitropin alfa followed by highly purified HMG versus recombinant FSH in young poor ovarian responders: a multicentre randomized controlled clinical trial.

    PubMed

    Drakopoulos, Panagiotis; Vuong, Thi Ngoc Lan; Ho, Ngoc Anh Vu; Vaiarelli, Alberto; Ho, Manh Tuong; Blockeel, Christophe; Camus, Michel; Lam, Anh Tuan; van de Vijver, Arne; Humaidan, Peter; Tournaye, Herman; Polyzos, Nikolaos P

    2017-11-01

    gestation). Secondary outcomes included embryo cryopreservation rates, clinical and biochemical pregnancy rates and number of oocytes retrieved. Overall, 152 poor ovarian responders defined by the 'Bologna' criteria were included in the study. Using an intention-to treat analysis, the ongoing pregnancy rates did not differ significantly between Group A 11/77 (14.3%) and Group B 11/70 (15.7%), absolute difference: -0.4 (-11.5 to 10.8), OR = 0.9 (0.4-2.4). Biochemical and clinical pregnancy rates, live birth rates and the number of oocytes retrieved were also comparable between the two groups. Nevertheless, more patients in the corifollitropin alfa group had cryopreserved embryos compared to the rFSH group [22 (28.6%) versus 10 (14.3%), OR = 2.4 (1.01-5.5)]. Incidentally, Asian patients had significantly lower cancellation rates compared to European poor responders [2/64 (3.1%) versus 17/83 (20.4%), OR = 0.12 (0.03-0.5)]. This discrepancy could be explained by the fact that Asian women were better prognosis patients than European patients, with significantly lower FSH [9.8 (5.3) versus 11.5 (5.4), P = 0.017] and significantly higher AMH [1.1 (0.9) versus 0.4 (0.3), P-value <0.001] levels. Ongoing pregnancy rates close to 14% for both treatment groups differ significantly from the hypothesized primary outcome rates used in the power calculation. Therefore, our randomized trial might have been underpowered to detect smaller differences. The use of multiple secondary outcomes and multiple comparisons could have increased a Type 1 error. Finally, although the chance of selection biases remains low given the nature of the infertile population, the open-label design could have been a limitation. Poor ovarian response represents a challenge and although a specific protocol may have increased the number of cryopreserved embryos, no difference was observed in ongoing pregnancy rates. Our study, being one of the largest RCTs in 'Bologna' criteria poor responders, highlights that

  20. Increased length of inpatient stay and poor clinical coding: audit of patients with diabetes.

    PubMed

    Daultrey, Harriet; Gooday, Catherine; Dhatariya, Ketan

    2011-11-01

    People with diabetes stay in hospital for longer than those without diabetes for similar conditions. Clinical coding is poor across all specialties. Inpatients with diabetes often have unrecognized foot problems. We wanted to look at the relationships between these factors. A single day audit, looking at the prevalence of diabetes in all adult inpatients. Also looking at their feet to find out how many were high-risk or had existing problems. A 998-bed university teaching hospital. All adult inpatients. (a) To see if patients with diabetes and foot problems were in hospital for longer than the national average length of stay compared with national data; (b) to see if there were people in hospital with acute foot problems who were not known to the specialist diabetic foot team; and (c) to assess the accuracy of clinical coding. We identified 110 people with diabetes. However, discharge coding data for inpatients on that day showed 119 people with diabetes. Length of stay (LOS) was substantially higher for those with diabetes compared to those without (± SD) at 22.39 (22.26) days, vs. 11.68 (6.46) (P < 0.001). Finally, clinical coding was poor with some people who had been identified as having diabetes on the audit, who were not coded as such on discharge. Clinical coding - which is dependent on discharge summaries - poorly reflects diagnoses. Additionally, length of stay is significantly longer than previous estimates. The discrepancy between coding and diagnosis needs addressing by increasing the levels of awareness and education of coders and physicians. We suggest that our data be used by healthcare planners when deciding on future tariffs.

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

    PubMed

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

    2013-03-07

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

  2. Clinical outcome of pediatric collagenous gastritis: Case series and review of literature

    PubMed Central

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

    2013-01-01

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

  3. Therapeutic hypothermia after cardiac arrest: outcome predictors

    PubMed Central

    Leão, Rodrigo Nazário; Ávila, Paulo; Cavaco, Raquel; Germano, Nuno; Bento, Luís

    2015-01-01

    Objective The determination of coma patient prognosis after cardiac arrest has clinical, ethical and social implications. Neurological examination, imaging and biochemical markers are helpful tools accepted as reliable in predicting recovery. With the advent of therapeutic hypothermia, these data need to be reconfirmed. In this study, we attempted to determine the validity of different markers, which can be used in the detection of patients with poor prognosis under hypothermia. Methods Data from adult patients admitted to our intensive care unit for a hypothermia protocol after cardiac arrest were recorded prospectively to generate a descriptive and analytical study analyzing the relationship between clinical, neurophysiological, imaging and biochemical parameters with 6-month outcomes defined according to the Cerebral Performance Categories scale (good 1-2, poor 3-5). Neuron-specific enolase was collected at 72 hours. Imaging and neurophysiologic exams were carried out in the 24 hours after the rewarming period. Results Sixty-seven patients were included in the study, of which 12 had good neurological outcomes. Ventricular fibrillation and electroencephalographic theta activity were associated with increased likelihood of survival and improved neurological outcomes. Patients who had more rapid cooling (mean time of 163 versus 312 minutes), hypoxic-ischemic brain injury on magnetic resonance imaging or neuron-specific enolase > 58ng/mL had poor neurological outcomes (p < 0.05). Conclusion Hypoxic-ischemic brain injury on magnetic resonance imaging and neuron-specific enolase were strong predictors of poor neurological outcomes. Although there is the belief that early achievement of target temperature improves neurological prognoses, in our study, there were increased mortality and worse neurological outcomes with earlier target-temperature achievement. PMID:26761469

  4. Differences in clinical presentation and pregnancy outcomes in antepartum preeclampsia and new-onset postpartum preeclampsia: Are these the same disorder?

    PubMed

    Vilchez, Gustavo; Hoyos, Luis R; Leon-Peters, Jocelyn; Lagos, Moraima; Argoti, Pedro

    2016-11-01

    New-onset postpartum preeclampsia is a poorly defined condition that accounts for a significant percentage of eclampsia cases. It is unclear whether new-onset postpartum preeclampsia is a different disorder from or belongs to the same spectrum of classic antepartum preeclampsia. The objective of this study was to compare the clinical presentation and pregnancy outcomes of antepartum preeclampsia and new-onset postpartum preeclampsia. A retrospective study including 92 patients with antepartum preeclampsia and 92 patients with new-onset postpartum preeclampsia was performed. Clinical presentation and pregnancy outcomes were compared. Chi-square test was used to analyze categorical variables, and independent t -test and Mann-Whitney U -test for numerical variables. P -values of <0.05 were used to indicate statistical signifi cance. Patients with antepartum preeclampsia and new-onset postpartum preeclampsia differ significantly in profile, symptoms at presentation, laboratory markers and pregnancy outcomes. New-onset postpartum preeclampsia has a distinct patient profile and clinical presentation than antepartum preeclampsia, suggesting they may represent different disorders. Characterization of a patient profile with increased risk of developing this condition will help clinicians to identify patients at risk and provide early and targeted interventions to decrease the morbidity associated with this condition.

  5. Food insecurity is associated with poor sleep outcomes among US adults.

    PubMed

    Ding, Meng; Keiley, Margaret K; Garza, Kimberly B; Duffy, Patricia A; Zizza, Claire A

    2015-03-01

    Although food insecure (FI) adults are at risk of chronic conditions, little research attention is given to their health behaviors, such as sleep. We examined the associations between adult food security status and sleep duration, sleep latency, and sleep complaints reported to a health care professional. Our population-based sample included 5637 men and 5264 women (≥22 y) who participated in the NHANES 2005-2010. Food security status was assessed with USDA's 10-item adult Food Security Survey Module. Self-reported information about sleep duration, sleep latency, and sleep complaints to a health care professional were used as sleep outcomes. Multiple linear, stratified by sex, and logistic regression models were used to estimate the association between food security status and the 3 sleep outcomes. Very low food secure (FS) women reported significantly shorter sleep duration than fully FS women (difference: -30 ± 5.2 min; P < 0.01); however, no relation to sleep duration was observed among men. Among men, participants who were marginally FS (4 ± 1.1 min), low FS (4 ± 1.7 min), and very low FS (5 ± 1.8 min) reported significantly longer sleep latency than fully FS men (P < 0.05), but no association with sleep latency was observed among women. The divergent patterns in sleep duration and latency were likely because of our reference groups reporting undesirable sleep outcomes; fully FS men reported inadequate sleep and fully FS women reported long sleep latency. Among both men and women, marginally FS (OR: 1.64; 95% CI: 1.24, 2.16), low FS (OR: 1.63; 95% CI: 1.16, 2.30), and very low FS (OR: 1.99; 95% CI: 1.36, 2.92) participants were more likely to report sleep complaints than their fully FS counterparts (P < 0.05). Poor sleep quantity and quality may predispose FI adults to adverse health outcomes. © 2015 American Society for Nutrition.

  6. Consequences of Growing Up Poor.

    ERIC Educational Resources Information Center

    Duncan, Greg J., Ed.; Brooks-Gunn, Jeanne, Ed.

    The consequences and correlates of growing up poor as well as the mechanisms through which poverty influences children are explored. This book is organized with a primary focus on research findings and a secondary concern with policy implications. The chapters are: (1) "Poor Families, Poor Outcomes: The Well-Being of Children and Youth" (Jeanne…

  7. Lansoprazole for children with poorly controlled asthma: a randomized controlled trial.

    PubMed

    Holbrook, Janet T; Wise, Robert A; Gold, Benjamin D; Blake, Kathryn; Brown, Ellen D; Castro, Mario; Dozor, Allen J; Lima, John J; Mastronarde, John G; Sockrider, Marianna M; Teague, W Gerald

    2012-01-25

    Asymptomatic gastroesophageal reflux (GER) is prevalent in children with asthma. Untreated GER has been postulated to be a cause of inadequate asthma control in children despite inhaled corticosteroid treatment, but it is not known whether treatment with proton pump inhibitors improves asthma control. To determine whether lansoprazole is effective in reducing asthma symptoms in children without overt GER. The Study of Acid Reflux in Children With Asthma, a randomized, masked, placebo-controlled, parallel clinical trial that compared lansoprazole with placebo in children with poor asthma control who were receiving inhaled corticosteroid treatment. Three hundred six participants enrolled from April 2007 to September 2010 at 19 US academic clinical centers were followed up for 24 weeks. A subgroup had an esophageal pH study before randomization. Participating children were randomly assigned to receive either lansoprazole, 15 mg/d if weighing less than 30 kg or 30 mg/d if weighing 30 kg or more (n = 149), or placebo (n = 157). The primary outcome measure was change in Asthma Control Questionnaire (ACQ) score (range, 0-6; a 0.5-unit change is considered clinically meaningful). Secondary outcome measures included lung function measures, asthma-related quality of life, and episodes of poor asthma control. The mean age was 11 years (SD, 3 years). The mean difference in change (lansoprazole minus placebo) in the ACQ score was 0.2 units (95% CI, 0.0-0.3 units). There were no statistically significant differences in the mean difference in change for the secondary outcomes of forced expiratory volume in the first second (0.0 L; 95% CI, -0.1 to 0.1 L), asthma-related quality of life (-0.1; 95% CI, -0.3 to 0.1), or rate of episodes of poor asthma control (relative risk, 1.2; 95% CI, 0.9-1.5). Among the 115 children with esophageal pH studies, the prevalence of GER was 43%. In the subgroup with a positive pH study, no treatment effect for lansoprazole vs placebo was observed for

  8. High extent of O-GlcNAcylation in breast cancer cells correlates with the levels of HAS enzymes, accumulation of hyaluronan, and poor outcome.

    PubMed

    Tiainen, Satu; Oikari, Sanna; Tammi, Markku; Rilla, Kirsi; Hämäläinen, Kirsi; Tammi, Raija; Kosma, Veli-Matti; Auvinen, Päivi

    2016-11-01

    Obesity and oversupply of glucose, e.g., due to nutritional factors may shape the tumor microenvironment favorable for tumor progression. O-GlcNAcylation, a reversible modification of intracellular proteins, influences on several cellular functions and is connected to many diseases including cancer. Glycosaminoglycan hyaluronan (HA) enhances tumor progression and in breast cancer HA accumulation associates strongly with poor outcome. In vitro studies have suggested that O-GlcNAcylation may enhance HA synthesis. The aim of this study was to investigate the correlations between O-GlcNAcylation, HA-related parameters, and disease outcome in a clinical breast cancer material consisting of 278 breast cancer cases. In microscopic analyses, O-GlcNAc staining of the breast carcinoma cells was evaluated in several randomly picked high-power fields of each section. The extent of cytoplasmic O-GlcNAc staining was graded as either low or high according to the intensity of the staining and the percentage of stained cells. The extent of nuclear O-GlcNAc staining was categorized as either low or high according to the percentage of stained nuclei. A high extent of both cytoplasmic and nuclear O-GlcNAcylation correlated with an increased relapse rate, development of distant metastases, and poor outcome. A high extent of cytoplasmic O-GlcNAcylation correlated also with the accumulation of all hyaluronan synthase (HAS1-3) proteins and with a large amount of HA in the tumor stroma. In addition, a high extent of nuclear O-GlcNAcylation associated with obesity. The results suggest a mechanistic association between increased O-GlcNAcylation and HA synthesis, leading to a HA-rich microenvironment favorable for breast cancer progression.

  9. Second trimester maternal urine for the diagnosis of trisomy 21 and prediction of poor pregnancy outcomes.

    PubMed

    Diaz, Sílvia O; Barros, António S; Goodfellow, Brian J; Duarte, Iola F; Galhano, Eulália; Pita, Cristina; Almeida, Maria do Céu; Carreira, Isabel M; Gil, Ana M

    2013-06-07

    Given the recognized lack of prenatal clinical methods for the early diagnosis of preterm delivery, intrauterine growth restriction, preeclampsia and gestational diabetes mellitus, and the continuing need for optimized diagnosis methods for specific chromosomal disorders (e.g., trisomy 21) and fetal malformations, this work sought specific metabolic signatures of these conditions in second trimester maternal urine, using (1)H Nuclear Magnetic Resonance ((1)H NMR) metabolomics. Several variable importance to the projection (VIP)- and b-coefficient-based variable selection methods were tested, both individually and through their intersection, and the resulting data sets were analyzed by partial least-squares discriminant analysis (PLS-DA) and submitted to Monte Carlo cross validation (MCCV) and permutation tests to evaluate model predictive power. The NMR data subsets produced significantly improved PLS-DA models for all conditions except for pre-premature rupture of membranes. Specific urinary metabolic signatures were unveiled for central nervous system malformations, trisomy 21, preterm delivery, gestational diabetes, intrauterine growth restriction and preeclampsia, and biochemical interpretations were proposed. This work demonstrated, for the first time, the value of maternal urine profiling as a complementary means of prenatal diagnostics and early prediction of several poor pregnancy outcomes.

  10. Accreditation of Predoctoral Dental Education: Clinical Outcomes Assessment.

    ERIC Educational Resources Information Center

    Boyd, Marcia A.; And Others

    1991-01-01

    The Curriculum Outcomes Review and Evaluation system of outcomes assessment for accreditation of Canadian dental faculties is described. Features include chart reviews; evaluation of diagnosis and treatment planning and case presentation for a student sample; structured clinical observation; presite visit survey; and solicitation of feedback from…

  11. Variation of clinical outcomes used in glaucoma randomised controlled trials: a systematic review.

    PubMed

    Ismail, Rehab; Azuara-Blanco, Augusto; Ramsay, Craig R

    2014-04-01

    In randomised clinical trials (RCTs) the selection of appropriate outcomes is crucial to the assessment of whether one intervention is better than another. The purpose of this review is to identify different clinical outcomes reported in glaucoma trials. We conducted a systematic review of glaucoma RCTs. A sample or selection of glaucoma trials were included bounded by a time frame (between 2006 and March 2012). Only studies in English language were considered. All clinical measured and reported outcomes were included. The possible variations of clinical outcomes were defined prior to data analysis. Information on reported clinical outcomes was tabulated and analysed using descriptive statistics. Other data recorded included type of intervention and glaucoma, duration of the study, defined primary outcomes, and outcomes used for sample size calculation, if nominated. The search strategy identified 4323 potentially relevant abstracts. There were 315 publications retrieved, of which 233 RCTs were included. A total of 967 clinical measures were reported. There were large variations in the definitions used to describe different outcomes and their measures. Intraocular pressure was the most commonly reported outcome (used in 201 RCTs, 86%) with a total of 422 measures (44%). Safety outcomes were commonly reported in 145 RCTs (62%) whereas visual field outcomes were used in 38 RCTs (16%). There is a large variation in the reporting of clinical outcomes in glaucoma RCTs. This lack of standardisation may impair the ability to evaluate the evidence of glaucoma interventions.

  12. Does Percent Body Fat Predict Outcome in Anorexia Nervosa?

    PubMed Central

    Mayer, Laurel E.S.; Roberto, Christina A.; Glasofer, Deborah R.; Etu, Sarah Fischer; Gallagher, Dympna; Wang, Jack; Heymsfield, Steven B.; Pierson, Richard N.; Attia, Evelyn; Devlin, Michael J.; Walsh, B. Timothy

    2009-01-01

    Objective The goal of this study was to investigate the relationship of body composition and neuroendocrine levels with clinical outcome in women with anorexia nervosa in a relapse-prevention trial. Method Body composition and fasting cortisol and leptin levels were assessed before random assignment in 32 weight-recovered subjects with anorexia nervosa from the New York site of the Fluoxetine to Prevent Relapse in Women With Anorexia Nervosa trial. Clinical outcome at the end of study participation was defined using modified Morgan-Russell criteria (full, good, fair, poor), then dichotomized into treatment “success” or “failure.” Results In a binary logistic regression model examining the effect of percent body fat, body mass index, anorexia nervosa subtype, waist-to-hip ratio, and serum cortisol and leptin levels on treatment outcome, only percent body fat was significantly associated with outcome. Conclusions In recently weight-restored women with anorexia nervosa, lower percent body fat was associated with poor long-term outcome. PMID:17541059

  13. Atrioventricular valve repair in patients with single-ventricle physiology: mechanisms, techniques of repair, and clinical outcomes.

    PubMed

    Honjo, Osami; Mertens, Luc; Van Arsdell, Glen S

    2011-01-01

    Significant atrioventricular (AV) valve insufficiency in patient with single ventricle-physiology is strongly associated with poor survival. Herein we discuss the etiology and mechanism of development of significant AV valve insufficiency in patients with single-ventricle physiology, surgical indication and repair techniques, and clinical outcomes along with our 10-year surgical experience. Our recent clinical series and literature review indicate that it is of prime importance to appreciate the high incidence and clinical effect of the structural abnormalities of AV valve. Valve repair at stage II palliation may minimize the period of volume overload, thereby potentially preserving post-repair ventricular function. Since 85% of the AV valve insufficiency was associated with structural abnormalities, inspection of an AV valve that has more than mild to moderate insufficiency is recommended because they are not likely to be successfully treated with volume unloading surgery alone. Copyright © 2011 Elsevier Inc. All rights reserved.

  14. Comparison of Survival Outcomes Among Cancer Patients Treated In and Out of Clinical Trials

    PubMed Central

    2014-01-01

    Background Clinical trials test the efficacy of a treatment in a select patient population. We examined whether cancer clinical trial patients were similar to nontrial, “real-world” patients with respect to presenting characteristics and survival. Methods We reviewed the SWOG national clinical trials consortium database to identify candidate trials. Demographic factors, stage, and overall survival for patients in the standard arms were compared with nontrial control subjects selected from the Surveillance, Epidemiology, and End Results program. Multivariable survival analyses using Cox regression were conducted. The survival functions from aggregate data across all studies were compared separately by prognosis (≥50% vs <50% average 2-year survival). All statistical tests were two-sided. Results We analyzed 21 SWOG studies (11 good prognosis and 10 poor prognosis) comprising 5190 patients enrolled from 1987 to 2007. Trial patients were younger than nontrial patients (P < .001). In multivariable analysis, trial participation was not associated with improved overall survival for all 11 good-prognosis studies but was associated with better survival for nine of 10 poor-prognosis studies (P < .001). The impact of trial participation on overall survival endured for only 1 year. Conclusions Trial participation was associated with better survival in the first year after diagnosis, likely because of eligibility criteria that excluded higher comorbidity patients from trials. Similar survival patterns between trial and nontrial patients after the first year suggest that trial standard arm outcomes are generalizable over the long term and may improve confidence that trial treatment effects will translate to the real-world setting. Reducing eligibility criteria would improve access to clinical trials. PMID:24627276

  15. Early termination of cardiovascular trials as a consequence of poor accrual: analysis of ClinicalTrials.gov 2006–2015

    PubMed Central

    Baldi, Ileana; Lanera, Corrado; Berchialla, Paola; Gregori, Dario

    2017-01-01

    Objectives To present a snapshot of experimental cardiovascular research with a focus on geographical and temporal patterns of early termination due to poor accrual. Setting The Aggregate Analysis of ClinicalTrials.gov (AACT) database, reflecting ClinicalTrials.gov as of 27 March 2016. Design The AACT database was searched for all cardiovascular clinical trials that started from January 2006 up to December 2015. Results Thirteen thousand and seven hundred twenty-nine cardiovascular trials were identified. Of these, 8900 (65%) were classified as closed studies. Globally, 11% of closed trials were terminated. This proportion varied from 9.6% to 14% for trials recruiting from Europe and Americas, respectively, with a slightly decreasing trend (p=0.02) over the study period. The most common reason for trials failing to complete was poor accrual (41%). Intercontinental trials exhibited lower figures of poor accrual as the reason for their early stopping, as compared with trials recruiting in a single continent (28% vs 44%, p=0.002). Conclusions Poor accrual significantly challenges the successful completion of cardiovascular clinical trials. Findings are suggestive of a positive effect of globalisation of cardiovascular clinical research on the achievement of enrolment goals within a reasonable time frame. PMID:28619765

  16. Quality of reporting of randomized clinical trials in implant dentistry. A systematic review on critical aspects in design, outcome assessment and clinical relevance.

    PubMed

    Cairo, Francesco; Sanz, Ignacio; Matesanz, Paula; Nieri, Michele; Pagliaro, Umberto

    2012-02-01

    The aim of this systematic review (SR) was to assess the quality of reporting randomized clinical trials (RCTs) in the field of implant dentistry, its evolution over time and the possible relations between quality items and reported outcomes. RCTs in implant dentistry were retrieved through electronic and hand searches. Risk of bias in individual studies was assessed focusing on study design, outcome assessment and clinical relevance. Associations between quality items and year of publication of RCTs or reporting of statistically significant outcomes were tested. Among the 495 originally screened manuscripts published from 1989 to April 2011, 276 RCTs were assessed in this SR; 59% of them were published between 2006 and 2011. RCTs were mainly parallel (65%), with a single centre (83%) and a superiority design (88%). Trials in implant dentistry showed several methodological flaws: only 37% showed a random sequence generation at low risk of bias, 75% did not provide information on allocation concealment, only 12% performed a correct sample size calculation, the examiner was blind solely in 42% of studies where blinding was feasible. In addition, only 21% of RCTs declared operator experience and 31% reported patient-related outcomes. Many quality items improved over time. Allocation concealment at high risk of bias (p = 0.0125), no information on drop-out (p = 0.0318) and lack of CONSORT adherence (p = 0.0333) were associated with statistically significant reported outcomes. The overall quality of reporting of RCTs in implant dentistry is poor and only partially improved in the last years. Caution is suggested when interpreting these RCTs since risk of bias was associated with higher chance of reporting of statistically significant results. © 2012 John Wiley & Sons A/S.

  17. Contrast enema findings in patients presenting with poor functional outcome after primary repair for Hirschsprung disease.

    PubMed

    Garrett, Kevin M; Levitt, Marc A; Peña, Alberto; Kraus, Steven J

    2012-09-01

    The radiologic evaluation of Hirschsprung disease is well described in the literature. However, there is a paucity of literature describing the appearance of the neo-rectum and colon after repair, specifically describing findings in patients with poor functional outcome, which would suggest the need for reoperation. We describe findings on contrast enema and correlate them with surgical findings at reoperation in children with poor functional outcome after primary repair for Hirschsprung disease who suffer from bowel dysfunction that can manifest with either soiling or obstructive symptoms such as enterocolitis. Children were identified from our colorectal surgery database. At the time of abstract submission, 35 children had contrast enemas prior to reoperation. Additional children continue to present for evaluation. The majority of children included in the study had their primary repair performed elsewhere. The initial procedures included: Duhamel (n = 11), Soave (n = 20) or Swenson (n = 3). One child had undergone a primary Soave repair and subsequently had a Swenson-type reoperation but continued to have a poor outcome. One child's initial surgical repair could not be determined. Images were reviewed by a staff pediatric radiologist and a pediatric radiology fellow. Findings encountered on contrast enema in these children include a distal narrowed segment due to stricture or aganglionic/transitional zone segment (8), dilated/hypomotile distal segment (7), thickened presacral space due to compressing Soave cuff (11), dilated Duhamel pouch (8), active enterocolitis (3) and partially obstructing twist of the pull-through segment (1). Multiple anatomical and pathological complications exist that can lead to bowel dysfunction in children after repair of Hirschsprung disease. Little recent literature exists regarding the radiographic findings in children. We had the opportunity to review a substantial series of these children, describe the contrast enema

  18. Clinical, virological, and biological parameters associated with outcomes of Ebola virus infection in Macenta, Guinea

    PubMed Central

    Vernet, Marie-Astrid; Reynard, Stéphanie; Fizet, Alexandra; Schaeffer, Justine; Pannetier, Delphine; Rives, Max; Georges, Nadia; Garcia-Bonnet, Nathalie; Sylla, Aboubacar I.; Grovogui, Péma; Kerherve, Jean-Yves; Savio, Christophe; Savio-Coste, Sylvie; de Séverac, Marie-Laure; Linares, Sandrine; Harouna, Souley; Abdoul, Bing M’Lebing; Petitjean, Frederic; Samake, Nenefing; Kinda, Moumouni; Koundouno, Fara Roger; Mateo, Mathieu; Lecine, Patrick; Page, Audrey; Tchamdja, Tang Maleki; Schoenhals, Matthieu; Barbe, Solenne; Simon, Bernard; Tran-Minh, Tuan; L’Hériteau, François

    2017-01-01

    BACKGROUND. The pathogenesis of Ebola virus (EBOV) disease (EVD) is poorly characterized. The establishment of well-equipped diagnostic laboratories close to Ebola treatment centers (ETCs) has made it possible to obtain relevant virological and biological data during the course of EVD and to assess their association with the clinical course and different outcomes of the disease. METHODS. We were responsible for diagnosing EBOV infection in patients admitted to two ETCs in forested areas of Guinea. The pattern of clinical signs was recorded, and an etiological diagnosis was established by RT-PCR for EBOV infection or a rapid test for malaria and typhoid fever. Biochemical analyses were also performed. RESULTS. We handled samples from 168 patients between November 29, 2014, and January 31, 2015; 97 patients were found to be infected with EBOV, with Plasmodium falciparum coinfection in 18%. Overall mortality for EVD cases was 58%, rising to 86% if P. falciparum was also present. Viral load was higher in fatal cases of EVD than in survivors, and fatal cases were associated with higher aspartate aminotransferase (AST) and alanine aminotransferase (ALT), C-reactive protein (CRP), and IL-6 levels. Furthermore, regardless of outcome, EVD was characterized by higher creatine kinase (CPK), amylase, and creatinine levels than in febrile patients without EVD, with higher blood urea nitrogen (BUN) levels in fatal cases of EVD only. CONCLUSION. These findings suggest that a high viral load at admission is a marker of poor EVD prognosis. In addition, high AST, ALT, CRP, and IL-6 levels are associated with a fatal outcome of EVD. Damage to the liver and other tissues, with massive rhabdomyolysis and, probably, acute pancreatitis, is associated with EVD and correlated with disease severity. Finally, biochemical analyses provide substantial added value at ETCs, making it possible to improve supportive rehydration and symptomatic care for patients. FUNDING. The French Ministry of

  19. Clinical, virological, and biological parameters associated with outcomes of Ebola virus infection in Macenta, Guinea.

    PubMed

    Vernet, Marie-Astrid; Reynard, Stéphanie; Fizet, Alexandra; Schaeffer, Justine; Pannetier, Delphine; Guedj, Jeremie; Rives, Max; Georges, Nadia; Garcia-Bonnet, Nathalie; Sylla, Aboubacar I; Grovogui, Péma; Kerherve, Jean-Yves; Savio, Christophe; Savio-Coste, Sylvie; de Séverac, Marie-Laure; Zloczewski, Philippe; Linares, Sandrine; Harouna, Souley; Abdoul, Bing M'Lebing; Petitjean, Frederic; Samake, Nenefing; Shepherd, Susan; Kinda, Moumouni; Koundouno, Fara Roger; Joxe, Ludovic; Mateo, Mathieu; Lecine, Patrick; Page, Audrey; Tchamdja, Tang Maleki; Schoenhals, Matthieu; Barbe, Solenne; Simon, Bernard; Tran-Minh, Tuan; Longuet, Christophe; L'Hériteau, François; Baize, Sylvain

    2017-03-23

    BACKGROUND. The pathogenesis of Ebola virus (EBOV) disease (EVD) is poorly characterized. The establishment of well-equipped diagnostic laboratories close to Ebola treatment centers (ETCs) has made it possible to obtain relevant virological and biological data during the course of EVD and to assess their association with the clinical course and different outcomes of the disease. METHODS. We were responsible for diagnosing EBOV infection in patients admitted to two ETCs in forested areas of Guinea. The pattern of clinical signs was recorded, and an etiological diagnosis was established by RT-PCR for EBOV infection or a rapid test for malaria and typhoid fever. Biochemical analyses were also performed. RESULTS. We handled samples from 168 patients between November 29, 2014, and January 31, 2015; 97 patients were found to be infected with EBOV, with Plasmodium falciparum coinfection in 18%. Overall mortality for EVD cases was 58%, rising to 86% if P . falciparum was also present. Viral load was higher in fatal cases of EVD than in survivors, and fatal cases were associated with higher aspartate aminotransferase (AST) and alanine aminotransferase (ALT), C-reactive protein (CRP), and IL-6 levels. Furthermore, regardless of outcome, EVD was characterized by higher creatine kinase (CPK), amylase, and creatinine levels than in febrile patients without EVD, with higher blood urea nitrogen (BUN) levels in fatal cases of EVD only. CONCLUSION. These findings suggest that a high viral load at admission is a marker of poor EVD prognosis. In addition, high AST, ALT, CRP, and IL-6 levels are associated with a fatal outcome of EVD. Damage to the liver and other tissues, with massive rhabdomyolysis and, probably, acute pancreatitis, is associated with EVD and correlated with disease severity. Finally, biochemical analyses provide substantial added value at ETCs, making it possible to improve supportive rehydration and symptomatic care for patients. FUNDING. The French Ministry of

  20. Clinical Presentations and Outcomes of Bile Duct Loss caused by Drugs and Herbal and Dietary Supplements

    PubMed Central

    Bonkovsky, Herbert L.; Kleiner, David E.; Gu, Jiezhun; Odin, Joseph A.; Russo, Mark W.; Navarro, Victor M.; Fontana, Robert J.; Ghabril, Marwan S.; Barnhart, Huiman; Hoofnagle, Jay H.

    2016-01-01

    Bile duct loss during the course of drug induced liver injury is uncommon but can be an indication of vanishing bile duct syndrome. In this work we assess the frequency, causes, clinical features and outcomes of cases of drug induced liver injury with histologically proven bile duct loss. All cases of drug induced liver injury enrolled into a prospective database over a ten year period that had undergone liver biopsies (n=363) were scored for the presence of bile duct loss and assessed for clinical and laboratory features, causes and outcomes. 26 of the 363 patients (7%) with drug, herbal or dietary supplement associated liver injury had bile duct loss on liver biopsy which was moderate to severe (<50% of portal areas with bile ducts) in 14 and mild (50–75%) in 12. The presenting clinical features of the 26 cases varied, but the most common clinical pattern was a severe cholestatic hepatitis. The implicated agents included amoxicillin/clavulanate (n=3), temozolomide (n=3), various herbal products (n=3), azithromycin (n=2) and 15 other medications or dietary supplements. Compared to those without, those with bile duct loss were more likely to develop chronic liver injury (94% vs 47%), which was usually cholestatic and sometimes severe. Five patients died and two others underwent liver transplantation for progressive cholestasis despite treatment with corticosteroids and ursodiol. The most predictive factor of poor outcome was the degree of bile duct loss on liver biopsy. Conclusions Bile duct loss during acute cholestatic hepatitis is an ominous early indicator of possible vanishing bile duct syndrome, for which at present there are no known means of prevention or therapy. PMID:27981596

  1. CXCR6 upregulation contributes to a proinflammatory tumor microenvironment that drives metastasis and poor patient outcomes in hepatocellular carcinoma.

    PubMed

    Gao, Qiang; Zhao, Ying-Jun; Wang, Xiao-Ying; Qiu, Shuang-Jian; Shi, Ying-Hong; Sun, Jian; Yi, Yong; Shi, Jie-Yi; Shi, Guo-Ming; Ding, Zhen-Bin; Xiao, Yong-Sheng; Zhao, Zhong-Hua; Zhou, Jian; He, Xiang-Huo; Fan, Jia

    2012-07-15

    CXC chemokines and their cognate receptors have been implicated widely in cancer pathogenesis. In this study, we report a critical causal relationship between CXCR6 expression and tumorigenesis in the setting of human hepatocellular carcinoma (HCC). Among the CXC chemokine receptors, only CXCR6 was detected in all the hepatoma cell lines studied. Moreover, in HCC tissue, CXCR6 expression was significantly higher than in noncancerous liver tissues. Reduction of CXCR6 or its ligand CXCL16 in cancer cells reduced cell invasion in vitro and tumor growth, angiogenesis, and metastases in vivo. Importantly, loss of CXCR6 led to reduced Gr-1+ neutrophil infiltration and decreased neoangiogenesis in hepatoma xenografts via inhibition of proinflammatory cytokine production. Clinically, high expression of CXCR6 was an independent predictor of increased recurrence and poor survival in HCCs. Human HCC samples expressing high levels of CXCR6 also contained an increased number of CD66b+ neutrophils and microvessels, and the combination of CXCR6 and neutrophils was a superior predictor of recurrence and survival than either marker used alone. Together, our findings suggest that elevated expression of CXCR6 promotes HCC invasiveness and a protumor inflammatory environment and is associated with poor patient outcome. These results support the concept that inhibition of the CXCR6-CXCL16 pathway may improve prognosis after HCC treatment.

  2. Cough reflex attenuation and swallowing dysfunction in sub-acute post-stroke patients: prevalence, risk factors, and clinical outcome.

    PubMed

    Vilardell, N; Rofes, L; Nascimento, W V; Muriana, D; Palomeras, E; Clavé, P

    2017-01-01

    Cough and swallowing impairments in post-stroke patients (PSP) have been associated with increased risk for respiratory complications. To assess the prevalence of alterations in protective cough responses in subacute PSP and its association with oropharyngeal dysphagia (OD), clinical, and neurotopographic stroke factors and clinical outcomes. Three months after stroke, the cough reflex test (CRT) was performed by nebulizing incremental citric acid concentrations (7.8-1000 mmol L -1 ) to determine the concentration that elicited two and five coughs; OD was assessed by the volume-viscosity swallow test. Clinical and neurotopographic stroke risk factors and complications (readmissions, respiratory infections, institutionalization, and mortality) were recorded from 3 to 12 months post-stroke. We included 225 PSP. Prevalence of impaired CRT was 5.8%, that of OD was 40.4% (20.4% with impaired safety of swallow), and of both impairments was, 1.8%. No specific risk factors associated with impaired CRT were found; however, hemorrhagic, wide circulation infarction (TACI), and brainstem strokes delayed the cough response. OD was associated with age, TACI and poor functional and nutritional status. Outcome of PSPs was unaffected by impaired CRT but OD and impaired safety of swallow increased institutionalization, respiratory infections, and mortality with the poorest outcome for those with both impairments. Prevalence of subacute post-stroke OD and swallow safety impairments was much higher than CRT attenuation, and risk factors strongly differed suggesting that the swallow response receives a stronger cortical control than the cough reflex. OD has a greater impact on PSP clinical outcome than impaired cough, the poorest prognosis being for patients with both airway protective dysfunctions. © 2016 John Wiley & Sons Ltd.

  3. Composite outcomes in randomized clinical trials: arguments for and against.

    PubMed

    Ross, Sue

    2007-02-01

    Composite outcomes that combine a number of individual outcomes (such as types of morbidity) are frequently used as primary outcomes in obstetrical trials. The main argument for their use is to ensure that trials can answer important clinical questions in a timely fashion, without needing huge sample sizes. Arguments against their use are that composite outcomes may be difficult to use and interpret, leading to errors in sample size estimation, possible contradictory trial results, and difficulty in interpreting findings. Such problems may reduce the credibility of the research, and may impact on the implementation of findings. Composite outcomes are an attractive solution to help to overcome the problem of limited available resources for clinical trials. However, future studies should carefully consider both the advantages and disadvantages before using composite outcomes. Rigorous development and reporting of composite outcomes is essential if the research is to be useful.

  4. Infectious and autoantibody-associated encephalitis: clinical features and long-term outcome.

    PubMed

    Pillai, Sekhar C; Hacohen, Yael; Tantsis, Esther; Prelog, Kristina; Merheb, Vera; Kesson, Alison; Barnes, Elizabeth; Gill, Deepak; Webster, Richard; Menezes, Manoj; Ardern-Holmes, Simone; Gupta, Sachin; Procopis, Peter; Troedson, Christopher; Antony, Jayne; Ouvrier, Robert A; Polfrit, Yann; Davies, Nicholas W S; Waters, Patrick; Lang, Bethan; Lim, Ming J; Brilot, Fabienne; Vincent, Angela; Dale, Russell C

    2015-04-01

    Pediatric encephalitis has a wide range of etiologies, clinical presentations, and outcomes. This study seeks to classify and characterize infectious, immune-mediated/autoantibody-associated and unknown forms of encephalitis, including relative frequencies, clinical and radiologic phenotypes, and long-term outcome. By using consensus definitions and a retrospective single-center cohort of 164 Australian children, we performed clinical and radiologic phenotyping blinded to etiology and outcomes, and we tested archived acute sera for autoantibodies to N-methyl-D-aspartate receptor, voltage-gated potassium channel complex, and other neuronal antigens. Through telephone interviews, we defined outcomes by using the Liverpool Outcome Score (for encephalitis). An infectious encephalitis occurred in 30%, infection-associated encephalopathy in 8%, immune-mediated/autoantibody-associated encephalitis in 34%, and unknown encephalitis in 28%. In descending order of frequency, the larger subgroups were acute disseminated encephalomyelitis (21%), enterovirus (12%), Mycoplasma pneumoniae (7%), N-methyl-D-aspartate receptor antibody (6%), herpes simplex virus (5%), and voltage-gated potassium channel complex antibody (4%). Movement disorders, psychiatric symptoms, agitation, speech dysfunction, cerebrospinal fluid oligoclonal bands, MRI limbic encephalitis, and clinical relapse were more common in patients with autoantibodies. An abnormal outcome occurred in 49% of patients after a median follow-up of 5.8 years. Herpes simplex virus and unknown forms had the worst outcomes. According to our multivariate analysis, an abnormal outcome was more common in patients with status epilepticus, magnetic resonance diffusion restriction, and ICU admission. We have defined clinical and radiologic phenotypes of infectious and immune-mediated/autoantibody-associated encephalitis. In this resource-rich cohort, immune-mediated/autoantibody-associated etiologies are common, and the recognition and

  5. Subclinical hyperthyroidism is a risk factor for poor functional outcome after ischemic stroke.

    PubMed

    Wollenweber, Frank Arne; Zietemann, Vera; Gschwendtner, Andreas; Opherk, Christian; Dichgans, Martin

    2013-05-01

    Subclinical hyperthyroidism is associated with adverse cardiovascular events, including stroke and atrial fibrillation. However, its impact on functional outcome after stroke remains unexplored. A total of 165 consecutively recruited patients admitted for ischemic stroke were included in this observational prospective study. Blood samples were taken in the morning within 3 days after symptom onset, and patients were divided into the following 3 groups: subclinical hyperthyroidism (0.1< thyroid-stimulating hormone ≤ 0.44 μU/mL), subclinical hypothyroidism (2.5 ≤ thyroid-stimulating hormone <20 μU/mL), and euthyroid state (0.44< thyroid-stimulating hormone <2.5 μU/mL). Patients with overt thyroid dysfunction were excluded. Follow-up took place 3 months after stroke. Primary outcome was functional disability (modified Rankin Scale), and secondary outcome was level of dependency (Barthel Index). Ordinal logistic regression analysis was used to adjust for possible confounders. Variables previously reported to be affected by thyroid function, such as atrial fibrillation, total cholesterol, or body mass index, were included in an additional model. Nineteen patients (11.5%) had subclinical hyperthyroidism, and 23 patients (13.9%) had subclinical hypothyroidism. Patients with subclinical hyperthyroidism had a substantially increased risk of functional disability 3 months after stroke compared with subjects with euthyroid state (odds ratio, 2.63; 95% confidence interval, 1.02-6.82, adjusted for age, sex, smoking status, and time of blood sampling). The association remained significant, when including the baseline NIHSS, TIA, serum CRP, atrial fibrillation, body mass index, and total cholesterol as additional variables (odds ratio, 3.95; 95% confidence interval, 1.25-12.47), and was confirmed by the secondary outcome (Barthel Index: odds ratio, 9.12; 95% confidence interval, 2.08-39.89). Subclinical hyperthyroidism is a risk factor for poor outcome 3 months after

  6. The effects of oral glutamine on clinical and survival outcomes of non-small cell lung cancer patients treated with chemoradiotherapy.

    PubMed

    Gul, Kanyilmaz; Mehmet, Koc; Meryem, Aktan

    2017-08-01

    To assess the efficacy of oral glutamine (Gln) supplementation on clinical and survival outcomes of patients with locally advanced non-small cell lung cancer (LA-NSCLC). Between 2010 and 2014, 122 stage III NSCLC patients were retrospectively analyzed. All patients received curative intent chemoradiotherapy (CRT). Prophylactic oral Gln powder was applied at a dose of 10 g tid. Effect of oral Gln supplementation in the prevention of severe (≥grade 2-3) acute radiation-induced esophagitis (ARE) and weight loss, and their relation with overall survival (OS) and disease-free survival (DFS) was measured. Median follow-up was 13.14 months (range; 1.97-55.36). Fifty-six (46%) patients had received oral Gln. Severe ARE was significantly lower in Gln-supplemented group (30% vs 70%; p = 0.002). Gln-free patients demonstrated a higher weight loss (p = 0.0001). In multivariate analysis hemoglobin (hb) level (<12 g/dL; p = 0.01) and nodal stage (N3; p = 0.01) were poor prognostic factors that affect OS; Weight loss (p = 0.06) and Gln-free (p = 0.05) reached nearly significant levels that poorly affect OS. Similarly, nodal stage (N3, p = 0.014) and Gln-free (p = 0.035) were poor prognostic factors that affect DFS. Weight loss (≥2%, p = 0.06) and hb level (<12 g/dL, p = 0.07) reached borderline significance that poorly affect DFS. Nodal stage (N3) was the only poor prognostic factor that affect OS and DFS in univariate analysis (p = 0.01, p = 0.009; respectively). Oral Gln supplementation significantly reduces grade 2-3 esophagitis and weight loss and also no negative impact on tumor control and survival outcomes in patients with LA-NSCLC. Copyright © 2016 Elsevier Ltd and European Society for Clinical Nutrition and Metabolism. All rights reserved.

  7. Early-Onset Bipolar Disorder: Characteristics and Outcomes in the Clinic.

    PubMed

    Connor, Daniel F; Ford, Julian D; Pearson, Geraldine S; Scranton, Victoria L; Dusad, Asha

    2017-12-01

    To assess patient characteristics and clinician-rated outcomes for children diagnosed with early-onset bipolar disorder in comparison to a depressive disorders cohort from a single clinic site. To assess predictors of bipolar treatment response. Medical records from 714 consecutive pediatric patients evaluated and treated at an academic tertiary child and adolescent psychiatry clinic between 2006 and 2012 were reviewed. Charts of bipolar children (n = 49) and children with depressive disorders (n = 58) meeting study inclusion/exclusion criteria were compared on variables assessing clinical characteristics, treatments, and outcomes. Outcomes were assessed by using pre- and post-Clinical Global Impressions (CGI)-Severity and Children's Global Assessment Scale (CGAS) scores, and a CGI-Improvement score ≤2 at final visit determined responder status. Bipolar outcome predictors were assessed by using multiple linear regression. Clinic prevalence rates were 6.9% for early-onset bipolar disorder and 1.5% for very early-onset bipolar disorder. High rates of comorbid diagnoses, symptom severity, parental stress, and child high-risk behaviors were found in both groups. The bipolar cohort had higher rates of aggression and higher lifetime systems of care utilization. The final CGI and CGAS outcomes for unipolar depression patients differed statistically significantly from those for the bipolar cohort, reflecting better clinical status and more improvement at outcome for the depression patients. Both parent-reported Child Behavior Checklist total T-score at clinic admission and the number of lifetime systems-of-care for the child were significantly and inversely associated with improvement for the bipolar cohort. Early-onset bipolar disorder is a complex and heterogeneous psychiatric disorder. Evidence-based treatment should emphasize psychopharmacology with adjunctive family and individual psychotherapy. Strategies to improve engagement in treatment may be especially

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

    ERIC Educational Resources Information Center

    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…

  9. Early-Onset Invasive Candidiasis in Extremely Low Birth Weight Infants: Perinatal Acquisition Predicts Poor Outcome.

    PubMed

    Barton, Michelle; Shen, Alex; O'Brien, Karel; Robinson, Joan L; Davies, H Dele; Simpson, Kim; Asztalos, Elizabeth; Langley, Joanne; Le Saux, Nicole; Sauve, Reginald; Synnes, Anne; Tan, Ben; de Repentigny, Louis; Rubin, Earl; Hui, Chuck; Kovacs, Lajos; Yau, Yvonne C W; Richardson, Susan E

    2017-04-01

    Neonatal invasive candidiasis (IC) presenting in the first week of life is less common and less well described than later-onset IC. Risk factors, clinical features, and disease outcomes have not been studied in early-onset disease (EOD, ≤7 days) or compared to late-onset disease (LOD, >7 days). All extremely low birth weight (ELBW, <1000 g) cases with IC and controls from a multicenter study of neonatal candidiasis enrolled from 2001 to 2003 were included in this study. Factors associated with occurrence and outcome of EOD in ELBW infants were determined. Forty-five ELBW infants and their 84 matched controls were included. Fourteen (31%) ELBW infants had EOD. Birth weight <750 g, gestation <25 weeks, chorioamnionitis, and vaginal delivery were all strongly associated with EOD. Infection with Candida albicans, disseminated disease, pneumonia, and cardiovascular disease were significantly more common in EOD than in LOD. The EOD case fatality rate (71%) was higher than in LOD (32%) or controls (15%) (P = .0001). The rate of neurodevelopmental impairment and mortality combined was similar in EOD (86%) and LOD (72%), but higher than in controls (32%; P = .007). ELBW infants with EOD have a very poor prognosis compared to those with LOD. The role of perinatal transmission in EOD is supported by its association with chorioamnionitis, vaginal delivery, and pneumonia. Dissemination and cardiovascular involvement are common, and affected infants often die. Empiric treatment should be considered for ELBW infants delivered vaginally who have pneumonia and whose mothers have chorioamnionitis or an intrauterine foreign body. © The Author 2017. Published by Oxford University Press for the Infectious Diseases Society of America. All rights reserved. For permissions, e-mail: journals.permissions@oup.com.

  10. Germline determinants of clinical outcome of cutaneous melanoma

    PubMed Central

    Vogelsang, Matjaz; Wilson, Melissa; Kirchhoff, Tomas

    2016-01-01

    Cutaneous melanoma (CM) is the most lethal form of skin cancer. Despite the constant increase of melanoma incidence, which is in part due to incremental advances in early diagnostic modalities, mortality rates have not improved over the last decade and for advanced stages remain steadily high. While conventional prognostic biomarkers currently in use find significant utility for predicting overall general survival probabilities, they are not sensitive enough for a more personalized clinical assessment on an individual level. In recent years, the advent of genomic technologies has brought the promise of identification of germline DNA alterations that may associate with CM outcomes and hence represent novel biomarkers for clinical utilization. This review attempts to summarize the current state of knowledge of germline genetic factors studied for their impact on melanoma clinical outcomes. We also discuss ongoing problems and hurdles in validating such surrogates, and we also project future directions in discovery of more powerful germline genetic factors with clinical utility in melanoma prognostication. PMID:26342156

  11. Low self-concept in poor readers: prevalence, heterogeneity, and risk.

    PubMed

    McArthur, Genevieve; Castles, Anne; Kohnen, Saskia; Banales, Erin

    2016-01-01

    There is evidence that poor readers are at increased risk for various types of low self-concept-particularly academic self-concept. However, this evidence ignores the heterogeneous nature of poor readers, and hence the likelihood that not all poor readers have low self-concept. The aim of this study was to better understand which types of poor readers have low self-concept. We tested 77 children with poor reading for their age for four types of self-concept, four types of reading, three types of spoken language, and two types of attention. We found that poor readers with poor attention had low academic self-concept, while poor readers with poor spoken language had low general self-concept in addition to low academic self-concept. In contrast, poor readers with typical spoken language and attention did not have low self-concept of any type. We also discovered that academic self-concept was reliably associated with reading and receptive spoken vocabulary, and that general self-concept was reliably associated with spoken vocabulary. These outcomes suggest that poor readers with multiple impairments in reading, language, and attention are at higher risk for low academic and general self-concept, and hence need to be assessed for self-concept in clinical practice. Our results also highlight the need for further investigation into the heterogeneous nature of self-concept in poor readers.

  12. Low self-concept in poor readers: prevalence, heterogeneity, and risk

    PubMed Central

    Castles, Anne; Kohnen, Saskia; Banales, Erin

    2016-01-01

    There is evidence that poor readers are at increased risk for various types of low self-concept—particularly academic self-concept. However, this evidence ignores the heterogeneous nature of poor readers, and hence the likelihood that not all poor readers have low self-concept. The aim of this study was to better understand which types of poor readers have low self-concept. We tested 77 children with poor reading for their age for four types of self-concept, four types of reading, three types of spoken language, and two types of attention. We found that poor readers with poor attention had low academic self-concept, while poor readers with poor spoken language had low general self-concept in addition to low academic self-concept. In contrast, poor readers with typical spoken language and attention did not have low self-concept of any type. We also discovered that academic self-concept was reliably associated with reading and receptive spoken vocabulary, and that general self-concept was reliably associated with spoken vocabulary. These outcomes suggest that poor readers with multiple impairments in reading, language, and attention are at higher risk for low academic and general self-concept, and hence need to be assessed for self-concept in clinical practice. Our results also highlight the need for further investigation into the heterogeneous nature of self-concept in poor readers. PMID:27867764

  13. Core outcome sets for research and clinical practice.

    PubMed

    Chiarotto, Alessandro; Ostelo, Raymond W; Turk, Dennis C; Buchbinder, Rachelle; Boers, Maarten

    This masterclass introduces the topic of core outcome sets, describing rationale and methods for developing them, and providing some examples that are relevant for clinical research and practice. A core outcome set is a minimum consensus-based set of outcomes that should be measured and reported in all clinical trials for a specific health condition and/or intervention. Issues surrounding outcome assessment, such as selective reporting and inconsistency across studies, can be addressed by the development of a core set. As suggested by key initiatives in this field (i.e. OMERACT and COMET), the development requires achieving consensus on: (1) core outcome domains and (2) core outcome measurement instruments. Different methods can be used to reach consensus, including: literature systematic reviews to inform the process, qualitative research with clinicians and patients, group discussions (e.g. nominal group technique), and structured surveys (e.g. Delphi technique). Various stakeholders should be involved in the process, with particular attention to patients. Several COSs have been developed for musculoskeletal conditions including a longstanding one for low back pain, IMMPACT recommendations on outcomes for chronic pain, and OMERACT COSs for hip, knee and hand osteoarthritis. There is a lack of COSs for neurological, geriatric, cardio-respiratory and pediatric conditions, therefore, future research could determine the value of developing COSs for these conditions. Copyright © 2017 Associação Brasileira de Pesquisa e Pós-Graduação em Fisioterapia. Publicado por Elsevier Editora Ltda. All rights reserved.

  14. Between a bug and a hard place: Trypanosoma cruzi genetic diversity and the clinical outcomes of Chagas disease

    PubMed Central

    Messenger, Louisa A; Miles, Michael A; Bern, Caryn

    2015-01-01

    Over the last 30 years, concomitant with successful transnational disease control programs across Latin America, Chagas disease has expanded from a neglected, endemic parasitic infection of the rural poor to an urbanized chronic disease, and now a potentially emergent global health problem. Trypanosoma cruzi infection has a highly variable clinical course, ranging from complete absence of symptoms to severe and often fatal cardiovascular and/or gastrointestinal manifestations. To date, few correlates of clinical disease progression have been identified. Elucidating a putative role for T. cruzi strain diversity in Chagas disease pathogenesis is complicated by the scarcity of parasites in clinical specimens and the limitations of our contemporary genotyping techniques. This article systematically reviews the historical literature, given our current understanding of parasite genetic diversity, to evaluate the evidence for any association between T. cruzi genotype and chronic clinical outcome, risk of congenital transmission or reactivation and orally transmitted outbreaks. PMID:26162928

  15. A Qualitative Study of US Clinical Ethics Services: Objectives and Outcomes.

    PubMed

    McClimans, Leah; Pressgrove, Geah; Rhea, James

    2016-01-01

    The quality of clinical ethics services in health care organizations is increasingly seen as an important aspect of the overall quality of care. But measuring this quality is difficult because there is a lack of clarity and consensus regarding the objectives of clinical ethics and the best outcome domains to measure. The aim of this qualitative study is to explore the views of experts about the objectives and outcomes of clinical ethics services in the US. We interviewed 19 experts in clinical ethics, focusing on the appropriate objectives and outcomes of a clinical ethics service (CES). Participants were selected using a purposive snowball sampling strategy. The development of the interview protocol was informed by the clinical ethics literature as well as by research and theories that inform clinical ethics practice. Interviews were conducted by phone, recorded, and transcribed for individual analysis. Analysis proceeded through the development of a codebook of categories using QDA Miner software. Our experts identified 12 objectives and nine outcomes. Some of these identifications were familiar (e.g., mediation and satisfaction) and some were novel (e.g., be of service and transformation). We found that experts are divided in their emphasis on the kinds of objectives that are most important. In terms of outcomes, our experts were concerned with the appropriateness of different proxy and direct measures. This study provides the perspectives of a select group of experts on the objectives and outcomes appropriate for a CES in the United States. The themes identified will be used in future research to inform a Delphi study to refine and obtain expert consensus.

  16. Common Factor Mechanisms in Clinical Practice and Their Relationship with Outcome.

    PubMed

    Gaitan-Sierra, Carolina; Hyland, Michael E

    2015-01-01

    This study investigates three common factor mechanisms that could affect outcome in clinical practice: response expectancy, the affective expectation model and motivational concordance. Clients attending a gestalt therapy clinic (30 clients), a sophrology (therapeutic technique) clinic (33 clients) and a homeopathy clinic (31 clients) completed measures of expectancy and the Positive Affect and Negative Affect Schedule (PANAS) before their first session. After 1 month, they completed PANAS and measures of intrinsic motivation, perceived effort and empowerment. Expectancy was not associated with better outcome and was no different between treatments. Although some of the 54 clients who endorsed highest expectations showed substantial improvement, others did not: 19 had no change or deteriorated in positive affect, and 18 had the same result for negative affect. Intrinsic motivation independently predicted changes in negative affect (β = -0.23). Intrinsic motivation (β = 0.24), effort (β = 0.23) and empowerment (β = 0.20) independently predicted positive affect change. Expectancy (β = -0.17) negatively affected changes in positive affect. Clients found gestalt and sophrology to be more intrinsically motivating, empowering and effortful compared with homeopathy. Greater improvement in mood was found for sophrology and gestalt than for homeopathy clients. These findings are inconsistent with response expectancy as a common factor mechanism in clinical practice. The results support motivational concordance (outcome influenced by the intrinsic enjoyment of the therapy) and the affective expectation model (high expectations can lead for some clients to worse outcome). When expectancy correlates with outcome in some other studies, this may be due to confound between expectancy and intrinsic enjoyment. Common factors play an important role in outcome. Intrinsic enjoyment of a therapeutic treatment is associated with better outcome. Active engagement with a

  17. Treatment outcomes of saddle nose correction.

    PubMed

    Hyun, Sang Min; Jang, Yong Ju

    2013-01-01

    Many valuable classification schemes for saddle nose have been suggested that integrate clinical deformity and treatment; however, there is no consensus regarding the most suitable classification and surgical method for saddle nose correction. To present clinical characteristics and treatment outcome of saddle nose deformity and to propose a modified classification system to better characterize the variety of different saddle nose deformities. The retrospective study included 91 patients who underwent rhinoplasty for correction of saddle nose from April 1, 2003, through December 31, 2011, with a minimum follow-up of 8 months. Saddle nose was classified into 4 types according to a modified classification. Aesthetic outcomes were classified as excellent, good, fair, or poor. Patients underwent minor cosmetic concealment by dorsal augmentation (n = 8) or major septal reconstruction combined with dorsal augmentation (n = 83). Autologous costal cartilages were used in 40 patients (44%), and homologous costal cartilages were used in 5 patients (6%). According to postoperative assessment, 29 patients had excellent, 42 patients had good, 18 patients had fair, and 2 patients had poor aesthetic outcomes. No statistical difference in surgical outcome according to saddle nose classification was observed. Eight patients underwent revision rhinoplasty, owing to recurrence of saddle, wound infection, or warping of the costal cartilage for dorsal augmentation. We introduce a modified saddle nose classification scheme that is simpler and better able to characterize different deformities. Among 91 patients with saddle nose, 20 (22%) had unsuccessful outcomes (fair or poor) and 8 (9%) underwent subsequent revision rhinoplasty. Thus, management of saddle nose deformities remains challenging. 4.

  18. Implementation of an Oxytocin Checklist to Improve Clinical Outcomes.

    PubMed

    Sundin, Courtney; Mazac, Lauren; Ellis, Kathleen; Garbo, Candon

    Oxytocin is one of the most common drugs administered in obstetrics. Since its designation as a high-alert medication by the Institute for Safe Medication Practices in 2007, there has been much attention to oxytocin administration during labor. Oxytocin is generally safe when administered correctly, but adverse perinatal outcomes can occur during uterine tachysystole. The purpose of this project was to evaluate and compare results of maternal and fetal outcomes of induction of labor for women at term prior to and after implementation of a newly developed oxytocin checklist. To evaluate the practice change associated with the implementation of the new oxytocin checklist, 200 cases based on retrospective medical record reviews were compared with 200 cases after implementation. Use of the checklist was associated with several significant clinical outcomes, including decreases in tachysystole, decreases in cesarean births for concern about fetal status based on electronic fetal monitoring data, decreases in length of first stage labor, and decreases in maximum dose of oxytocin. Results are similar to previous research. Early physician buy-in, clinical team education, and ongoing evaluation enhanced facilitation of the oxytocin checklist. Clinical outcomes were favorable.

  19. TIAM1 variants improve clinical outcome in neuroblastoma.

    PubMed

    Sanmartín, Elena; Yáñez, Yania; Fornés-Ferrer, Victoria; Zugaza, José L; Cañete, Adela; Castel, Victoria; Font de Mora, Jaime

    2017-07-11

    Identification of tumor driver mutations is crucial for improving clinical outcome using a personalized approach to the treatment of cancer. Neuroblastoma is a tumor of the peripheral sympathetic nervous system for which only a few driver alterations have been described including MYCN amplification and ALK mutations. We assessed 106 primary neuroblastoma tumors by next generation sequencing using a customized amplicon-based gene panel. Our results reveal that genetic variants in TIAM1 gene associate with better clinical outcome, suggesting a role for these TIAM1 variants in preventing progression of this disease. The detected variants are located within the different domains of TIAM1 that signal to the upstream regulator RAS and downstream effector molecules MYC and RAC, which are all implicated in neuroblastoma etiology and progression. Clinical outcome was improved in tumors where a TIAM1 variant was present concomitantly with either ALK mutation or MYCN amplification. Given the function of these signaling molecules in cell survival, proliferation, differentiation and neurite outgrowth, our data suggest that the TIAM1-mediated network is essential to neuroblastoma and thus, inhibiting TIAM1 reflects a rational strategy for improving therapy efficacy in neuroblastoma.

  20. Open Tibial Inlay PCL Reconstruction: Surgical Technique and Clinical Outcomes.

    PubMed

    Vellios, Evan E; Jones, Kristofer J; McAllister, David R

    2018-06-01

    To review the current literature on clinical outcomes following open tibial inlay posterior cruciate ligament (PCL) reconstruction and provide the reader with a detailed description of the author's preferred surgical technique. Despite earlier biomechanical studies which demonstrated superiority of the PCL inlay technique when compared to transtibial techniques, recent longitudinal cohort studies have shown no significant differences in clinical or functional outcomes at 10-year follow-up. Furthermore, no significant clinical differences have been shown between graft types used and/or single- versus double-bundle reconstruction methods. The optimal treatment for the PCL-deficient knee remains unclear. Open tibial inlay PCL reconstruction is safe, reproducible, and avoids the "killer turn" that may potentially lead to graft weakening and failure seen in transtibial reconstruction methods. No significant differences in subjective outcomes or clinical laxity have been shown between single-bundle versus double-bundle reconstruction methods.

  1. Obstetric outcome in pregnant women subjected to domestic violence.

    PubMed

    Ameh, N; Shittu, S O; Abdul, M A

    2009-06-01

    To determine the prevalence of domestic violence and its relationship to adverse obstetric outcomes amongst pregnant women who deliver at a tertiary level hospital in Zaria, Nigeria. A cross-sectional study involving 310 women who delivered at the labour ward. Questionnaires were administered to parturient women. Details of their socio-demographic characteristics and obstetric outcome were compiled and the relationship to experiences of domestic violence studied. The prevalence of domestic violence was 28.4%. There was positive relationship between domestic violence during pregnancy, non-supervision of pregnancy and poor attendances to antenatal clinic (p<0.05). There was however, no statistically significant relationship between domestic violence, and complications of labour and neonatal outcome (p>0.05). The prevalence of domestic violence in pregnancy is high in this environment. Poor attendances to the antenatal clinic is a significant association.

  2. Defining quality for distal pancreatectomy: does the laparoscopic approach protect patients from poor quality outcomes?

    PubMed

    Baker, Marshall S; Sherman, Karen L; Stocker, Susan; Hayman, Amanda V; Bentrem, David J; Prinz, Richard A; Talamonti, Mark S

    2013-02-01

    Established systems for grading postoperative complications do not change the assigned grade when multiple interventions or readmissions are required to manage a complication. Studies using these systems may misrepresent outcomes for the surgical procedures being evaluated. We define a quality outcome for distal pancreatectomy (DP) and use this metric to compare laparoscopic distal pancreatectomy (LDP) to open distal pancreatectomy (ODP). Records for patients undergoing DP between January 2006 and December 2009 were reviewed. Clavien-Dindo grade IIIb, IV, and V complications were classified as severe adverse--poor quality--postoperative outcomes (SAPOs). II and IIIa complications requiring either significantly prolonged overall lengths of stay including readmissions within 90 days or more than one invasive intervention were also classified as SAPOs. By Clavien-Dindo system alone, 91 % of DP patients had either no complication or a low/moderate grade (I, II, IIIa) complication. Using our reclassification, however, 25 % had a SAPO. Patients undergoing LDP demonstrated a Clavien-Dindo complication profile identical to that for SDP but demonstrated significantly shorter overall lengths of stay, were less likely to require perioperative transfusion, and less likely to have a SAPO. Established systems undergrade the severity of some complications following DP. Using a procedure-specific metric for quality, we demonstrate that LDP affords a higher quality postoperative outcome than ODP.

  3. Improved clinical documentation leads to superior reportable outcomes: An accurate representation of patient's clinical status.

    PubMed

    Elkbuli, Adel; Godelman, Steven; Miller, Ashley; Boneva, Dessy; Bernal, Eileen; Hai, Shaikh; McKenney, Mark

    2018-05-01

    Clinical documentation can be an underappreciated. Trauma Centers (TCs) are now routinely evaluated for quality performance. TCs with poor documentation may not accurately reflect actual injury burden or comorbidities and can impact accuracy of mortality measures. Markers exist to adjust crude death rates for injury severity: observed over expected deaths (O/E) adjust for injury; Case Mix Index (CMI) reflects disease burden, and Severity of Illness (SOI) measures organ dysfunction. We aim to evaluate the impact of implementing a Clinical Documentation Improvement Program (CDIP) on reported outcomes. Review of 2-years of prospectively collected data for trauma patients, during the implementation of CDIP. A two-group prospective observational study design was used to evaluate the pre-implementation and the post-implementation phase of improved clinical documentation. T-test and Chi-Squared were used with significance defined as p < 0.05. In the pre-implementation period, there were 49 deaths out of 1419 (3.45%), while post-implementation period, had 38 deaths out of 1454 (2.61%), (non-significant). There was however, a significant difference between O/E ratios. In the pre-phase, the O/E was 1.36 and 0.70 in the post-phase (p < 0.001). The two groups also differed on CMI with a pre-group mean of 2.48 and a post-group of 2.87 (p < 0.001), indicating higher injury burden in the post-group. SOI started at 2.12 and significantly increased to 2.91, signifying more organ system dysfunction (p < 0.018). Improved clinical documentation results in improved accuracy of measures of mortality, injury severity, and comorbidities and a more accurate reflection in O/E mortality ratios, CMI, and SOI. Copyright © 2018 IJS Publishing Group Ltd. Published by Elsevier Ltd. All rights reserved.

  4. Clinical presentations and outcomes of bile duct loss caused by drugs and herbal and dietary supplements.

    PubMed

    Bonkovsky, Herbert L; Kleiner, David E; Gu, Jiezhun; Odin, Joseph A; Russo, Mark W; Navarro, Victor M; Fontana, Robert J; Ghabril, Marwan S; Barnhart, Huiman; Hoofnagle, Jay H

    2017-04-01

    Bile duct loss during the course of drug-induced liver injury is uncommon, but can be an indication of vanishing bile duct syndrome (VBDS). In this work, we assess the frequency, causes, clinical features, and outcomes of cases of drug-induced liver injury with histologically proven bile duct loss. All cases of drug-induced liver injury enrolled into a prospective database over a 10-year period that had undergone liver biopsies (n = 363) were scored for the presence of bile duct loss and assessed for clinical and laboratory features, causes, and outcomes. Twenty-six of the 363 patients (7%) with drug-, herbal-, or dietary-supplement-associated liver injury had bile duct loss on liver biopsy, which was moderate to severe (<50% of portal areas with bile ducts) in 14 and mild (50%-75%) in 12. The presenting clinical features of the 26 cases varied, but the most common clinical pattern was a severe cholestatic hepatitis. The implicated agents included amoxicillin/clavulanate (n = 3), temozolomide (n = 3), various herbal products (n = 3), azithromycin (n = 2), and 15 other medications or dietary supplements. Compared to those without, those with bile duct loss were more likely to develop chronic liver injury (94% vs. 47%), which was usually cholestatic and sometimes severe. Five patients died and 2 others underwent liver transplantation for progressive cholestasis despite treatment with corticosteroids and ursodiol. The most predictive factor of poor outcome was the degree of bile duct loss on liver biopsy. Bile duct loss during acute cholestatic hepatitis is an ominous early indicator of possible VBDS, for which at present there are no known means of prevention or therapy. (Hepatology 2017;65:1267-1277). © 2016 by the American Association for the Study of Liver Diseases.

  5. Impact of live interactive teledermatology on diagnosis, disease management, and clinical outcomes.

    PubMed

    Lamel, Sonia; Chambers, Cindy J; Ratnarathorn, Mondhipa; Armstrong, April W

    2012-01-01

    To assess the impact of live interactive teledermatology consultations on changes in diagnosis, disease management, and clinical outcomes. We conducted a retrospective analysis of 1500 patients evaluated via live interactive teledermatology between 2003 and 2005 at the University of California, Davis. We compared diagnoses and treatment plans between the referring physicians and the teledermatologists. Patients with 2 or more teledermatology visits within a 1-year period were assessed for changes in clinical outcomes. Academic medical center with an established teledermatology program since 1996. Medical records were evaluated for 1500 patients who underwent live interactive teledermatology consultation. Patients seen for more than 1 teledermatology visit were included in the clinical outcome assessment. Live interactive teledermatology consultation. Changes in diagnosis, disease management, and clinical outcome. Compared with diagnoses and treatment plans from referring physicians, the 1500 live interactive teledermatology consultations resulted in changes in diagnosis in 69.9% of patients and changes in disease management in 97.7% of patients. Among 313 patients with at least 2 teledermatology visits within 1 year, clinical improvement was observed in 68.7% of patients. Multivariate analysis showed that changes in diagnosis (P = .01), changes in disease management (P < .001), and the number of teledermatology visits (P < .001) were significantly associated with improved clinical outcomes. Live interactive teledermatology consultations result in changes in diagnosis and disease management in most consultations. The numbers of live interactive teledermatology visits and changes in diagnosis and disease management are significantly associated with improved clinical outcomes.

  6. Classic and nonclassic HLA class I expression in penile cancer and relation to HPV status and clinical outcome.

    PubMed

    Djajadiningrat, Rosa S; Horenblas, Simon; Heideman, Daniëlle A M; Sanders, Joyce; de Jong, Jeroen; Jordanova, Ekaterina S

    2015-04-01

    Loss of expression of HLA class I is a mechanism of immune evasion in various cancers that is often associated with a worse patient outcome. We analyzed HLA expression in a large cohort with penile cancer in relation to clinical outcome. We used penile cancer tissue blocks from 168 patients who underwent surgical resection between 2000 and 2009 to construct tissue microarrays. Immunohistochemical staining was done with antibodies directed against classic and nonclassic HLA molecules. HLA expression was scored semiquantitatively, divided into 3 expression groups and correlated with clinicopathological variables, including HPV and survival. Survival analysis was performed using the Kaplan-Meier method and Cox proportional hazards models. Complete and partial loss of total classic HLA class I was observed in 32% and 50% of cases, and up-regulation of HLA-E and G in 16% and 13%, respectively. When corrected for relevant clinical parameters, partial HLA-A loss was significantly associated with decreased survival overall (HR 2.3, 95% CI 1.1-4.6) and in HPV negative patients alone (HR 3.4, 95% CI 1.4-8.4). Abnormal HLA-B/C, E or G expression levels were not associated with survival. To our knowledge this is the first study to describe a link between HLA expression and the clinical outcome of penile cancer. HLA down-regulation occurs frequently and partial loss of HLA-A is an independent predictor of poor survival in HPV negative patients. Complete understanding of the mechanisms and relevance of HLA down-regulation and immune evasion in regard to the clinical outcome will contribute to the future design of immunotherapy interventions. Copyright © 2015 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.

  7. Statistical controversies in clinical research: comparison of primary outcomes in protocols, public clinical-trial registries and publications: the example of oncology trials.

    PubMed

    Perlmutter, A S; Tran, V-T; Dechartres, A; Ravaud, P

    2017-04-01

    Protocols are often unavailable to peer-reviewers and readers. To detect outcome reporting bias (ORB), readers usually have to resort to publicly available descriptions of study design such as public clinical trial registries. We compared primary outcomes in protocols, ClinicalTrials.gov and publications of oncology trials and evaluated the use of ClinicalTrials.gov as compared with protocols in detecting discrepancies between planned and published outcomes. We searched for phase III oncology trials registered in ClinicalTrials.gov and published in the Journal of Clinical Oncology and New England Journal of Medicine between January 2014 and June 2015. We extracted primary outcomes reported in the protocol, ClinicalTrials.gov and the publication. First, we assessed the quality of primary outcome descriptions by using a published framework. Second, we evaluated modifications of primary outcomes between each source. Finally, we evaluated the agreement, specificity and sensitivity of detecting modifications between planned and published outcomes by using protocols or ClinicalTrials.gov. We included 65 trials, with 81 primary outcomes common among the 3 sources. The proportion of primary outcomes reporting all items from the framework was 73%, 22%, and 75% for protocols, ClinicalTrials.gov and publications, respectively. Eight (12%) trials presented a discrepancy between primary outcomes reported in the protocol and in the publication. Twelve (18.5%) trials presented a discrepancy between primary outcomes registered at ClinicalTrials.gov and in publications. We found a moderate agreement in detecting discrepant reporting of outcomes by using protocols or ClinicalTrials.gov [κ = 0.53, 95% confidence interval (0.25-0.81)]. Using ClinicalTrials.gov to detect discrepant reporting of outcomes showed high specificity (89.5%) but lacked sensitivity (75%) as compared with use of protocols. In oncology trials, primary outcome descriptions in ClinicalTrials.gov are often of

  8. Clinical Prognosis in Neonatal Bacterial Meningitis: The Role of Cerebrospinal Fluid Protein.

    PubMed

    Tan, Jintong; Kan, Juan; Qiu, Gang; Zhao, Dongying; Ren, Fang; Luo, Zhongcheng; Zhang, Yongjun

    2015-01-01

    Neonates are at high risk of meningitis and of resulting neurologic complications. Early recognition of neonates at risk of poor prognosis would be helpful in providing timely management. From January 2008 to June 2014, we enrolled 232 term neonates with bacterial meningitis admitted to 3 neonatology departments in Shanghai, China. The clinical status on the day of discharge from these hospitals or at a postnatal age of 2.5 to 3 months was evaluated using the Glasgow Outcome Scale (GOS). Patients were classified into two outcome groups: good (167 cases, 72.0%, GOS = 5) or poor (65 cases, 28.0%, GOS = 1-4). Neonates with good outcome had less frequent apnea, drowsiness, poor feeding, bulging fontanelle, irritability and more severe jaundice compared to neonates with poor outcome. The good outcome group also had less pneumonia than the poor outcome group. Besides, there were statistically significant differences in hemoglobin, mean platelet volume, platelet distribution width, C-reaction protein, procalcitonin, cerebrospinal fluid (CSF) glucose and CSF protein. Multivariate logistic regression analyses suggested that poor feeding, pneumonia and CSF protein were the predictors of poor outcome. CSF protein content was significantly higher in patients with poor outcome. The best cut-offs for predicting poor outcome were 1,880 mg/L in CSF protein concentration (sensitivity 70.8%, specificity 86.2%). After 2 weeks of treatment, CSF protein remained higher in the poor outcome group. High CSF protein concentration may prognosticate poor outcome in neonates with bacterial meningitis.

  9. Patient-reported outcomes (PROs): the significance of using humanistic measures in clinical trial and clinical practice.

    PubMed

    Refolo, P; Minacori, R; Mele, V; Sacchini, D; Spagnolo, A G

    2012-10-01

    Patient-reported outcome (PRO) is an "umbrella term" that covers a whole range of potential types of measurement but it is used specifically to refer to all measures quantifying the state of health through the evaluation of outcomes reported by the patient himself/herself. PROs are increasingly seen as complementary to biomedical measures and they are being incorporated more frequently into clinical trials and clinical practice. After considering the cultural background of PROs - that is the well known patient-centered model of medicine -, their historical profile (since 1914, the year of the first outcome measure) and typologies, the paper aims at debating their methodological complexity and implementation into practice. Some clinical trials and therapeutic managements utilizing patient-centered measures will be also analyzed.

  10. Association between poor clinical prognosis and sleep duration among breast cancer patients.

    PubMed

    Mansano-Schlosser, Thalyta Cristina; Ceolim, Maria Filomena

    2017-06-05

    to investigate the association between clinical progression and the quality and duration of sleep in women with breast cancer. longitudinal study, with 114 participants, conducted in a hospital in Brazil. The instruments used were: questionnaire for sociodemographic and clinical characterization, Pittsburgh Sleep Quality Index; Beck Depression Inventory and Herth Hope Scale. Data were analyzed through descriptive statistics and survival analyses (outcome: poor clinical progression), using the Kaplan-Meier curve, Log-rank test and Cox proportional model. a higher probability of poor clinical progression was verified in women with sleep durations of less than six hours or nine hours and over (p=.0173). the results suggest the importance of further studies that seek to verify whether the quantitative management of sleep disorders would have an impact on the progression of breast cancer. Women should be encouraged to report sleep problems to nurses. mensurar a associação entre evolução clínica e qualidade e duração do sono em mulheres com câncer de mama. estudo longitudinal, com 114 participantes, realizado em um hospital do Brasil. Os instrumentos utilizados foram: questionário para caracterização sociodemográfica e clínica, Índice de Qualidade do Sono de Pittsburgh; Inventário de Depressão de Beck e Escala de Esperança de Herth. Os dados foram analisados via análises descritivas e de sobrevivência (resultado: evolução clínica desfavorável), utilizando-se a curva de Kaplan-Meier, o teste log-rank e o modelo proporcional de Cox. verificou-se maior probabilidade de evolução clínica desfavorável em mulheres com duração de sono inferior a seis ou mais de nove horas (p = 0,0173). os resultados sugerem a importância de mais estudos que buscam verificar se a gestão quantitativa dos distúrbios do sono teria um impacto sobre a evolução do câncer de mama. As mulheres devem ser encorajadas a relatar isso espontaneamente aos enfermeiros. medir

  11. Poor reporting of scientific leadership information in clinical trial registers.

    PubMed

    Sekeres, Melanie; Gold, Jennifer L; Chan, An-Wen; Lexchin, Joel; Moher, David; Van Laethem, Marleen L P; Maskalyk, James; Ferris, Lorraine; Taback, Nathan; Rochon, Paula A

    2008-02-20

    In September 2004, the International Committee of Medical Journal Editors (ICMJE) issued a Statement requiring that all clinical trials be registered at inception in a public register in order to be considered for publication. The World Health Organization (WHO) and ICMJE have identified 20 items that should be provided before a trial is considered registered, including contact information. Identifying those scientifically responsible for trial conduct increases accountability. The objective is to examine the proportion of registered clinical trials providing valid scientific leadership information. We reviewed clinical trial entries listing Canadian investigators in the two largest international and public trial registers, the International Standard Randomized Controlled Trial Number (ISRCTN) register, and ClinicalTrials.gov. The main outcome measures were the proportion of clinical trials reporting valid contact information for the trials' Principal Investigator (PI)/Co-ordinating Investigator/Study Chair/Site PI, and trial e-mail contact address, stratified by funding source, recruiting status, and register. A total of 1388 entries (142 from ISRCTN and 1246 from ClinicalTrials.gov) comprised our sample. We found non-compliance with mandatory registration requirements regarding scientific leadership and trial contact information. Non-industry and partial industry funded trials were significantly more likely to identify the individual responsible for scientific leadership (OR = 259, 95% CI: 95-701) and to provide a contact e-mail address (OR = 9.6, 95% CI: 6.6-14) than were solely industry funded trials. Despite the requirements set by WHO and ICMJE, data on scientific leadership and contact e-mail addresses are frequently omitted from clinical trials registered in the two leading public clinical trial registers. To promote accountability and transparency in clinical trials research, public clinical trials registers should ensure adequate monitoring of trial

  12. Acute viral bronchiolitis: Physician perspectives on definition and clinically important outcomes.

    PubMed

    Fernandes, Ricardo M; Andrade, Maria Gabriela; Constant, Carolina; Malveiro, Duarte; Magalhães, Manuel; Abreu, Daisy; Azevedo, Inês; Sousa, Eduarda; Salgado, Rizério; Bandeira, Teresa

    2016-07-01

    Two key limitations hamper intervention research in bronchiolitis: the absence of a clear definition of disease, and the heterogeneous choice of outcome measures in current clinical trials. We assessed how paediatricians and general practitioners (GPs) perceived definition and clinically important outcomes in bronchiolitis. A nationwide online survey (ABBA study) was conducted through the Portuguese Society of Paediatrics and GPs' mailing lists. We assessed agreement with statements on bronchiolitis definition, and participants were asked to score the relative importance of several outcomes. Principal component analysis (PCA) explored dimensions underlying disease definition. Outcomes were ranked by mean score and proportion given highest score. We included 514 paediatricians and 165 GPs (overall 59% were board-certified). Most paediatricians (76.5%) agreed with a definition based on coryza, wheezing and/or crackles/rales, compared to 38.1% GPs (P < 0.001). Less than 5% physicians agreed with a definition commonly used in clinical trials (<12 months, first episode of wheeze). We retained three dimensions on PCA: one based on coryza, rales/crepitations and no sudden onset; another on number of episodes and age; and a third on wheeze. Dimensions varied by physician specialization and training (P < 0.01). Hospital admission and respiratory distress were top rated outcomes by both groups of physicians. Physician definitions of bronchiolitis have considerable variability and often mismatch those of clinical trials. Rating of important outcomes was consistent. Our results highlight the need for a robust standardized definition of acute bronchiolitis in infants and support the development of a core outcome set for future clinical trials. Pediatr Pulmonol. 2016;51:724-732. © 2015 Wiley Periodicals, Inc. © 2015 Wiley Periodicals, Inc.

  13. Too cold may not be so cool: spontaneous hypothermia as a marker of poor outcome after cardiac arrest.

    PubMed

    Wörner, Jakobea; Oddo, Mauro

    2010-01-01

    In a recent issue of Critical Care, den Hartog and colleagues show an association between spontaneous hypothermia, defined by an admission body temperature < 35°C, and poor outcome in patients with coma after cardiac arrest (CA) treated with therapeutic hypothermia (TH). Given that TH alters neurological prognostication, studies aiming to identify early markers of injury severity and outcome are welcome, since they may contribute overall to optimize the management of comatose CA patients. This study provides an important message to clinicians involved in post-resuscitation care and raises important questions that need to be taken into account in future studies.

  14. Methylene blue is associated with poor outcomes in vasoplegic shock.

    PubMed

    Weiner, Menachem M; Lin, Hung-Mo; Danforth, Dennis; Rao, Srikar; Hosseinian, Leila; Fischer, Gregory W

    2013-12-01

    The purpose of this study was to investigate whether patients who received methylene blue as treatment for vasoplegia during cardiac surgery with cardiopulmonary bypass had decreased morbidity and mortality. Retrospective analysis. Single tertiary care university hospital. Adult patients who suffered from vasoplegia and underwent all types of cardiac surgery with cardiopulmonary bypass at this institution between 2007 and 2008. With IRB approval, the authors reviewed the charts of the identified patients and divided them into 2 groups based on whether they had received methylene blue. Two hundred twenty-six patients were identified who met the inclusion criteria for the study. Fifty-seven of these patients had received methylene blue for vasoplegia. The authors collected data on preoperative and intraoperative variables as well as outcomes. The patients who received methylene blue had higher rates of in-hospital mortality, a compilation of morbidities, as well as renal failure and hyperbilirubinemia. A multiple logistic regression model demonstrated that receiving methylene blue was an independent predictor of in-hospital mortality (p value: 0.007, OR 4.26, 95% CI: 1.49-12.12), compilation of morbidities (p value: 0.001, OR 4.80, 95% CI: 1.85-12.43), and hyperbilirubinemia (p value:<0.001, OR 6.58, 95% CI: 2.91-14.89). Using propensity score matching, the association with morbidity was again seen but the association with mortality was not found. The current study identified the use of methylene blue as treatment for vasoplegia to be independently associated with poor outcomes. While further studies are required, a thorough risk-benefit analysis should be applied before using methylene blue and, perhaps, it should be relegated to rescue use and not as first-line therapy. Copyright © 2013 Elsevier Inc. All rights reserved.

  15. Education Research: Bias and poor interrater reliability in evaluating the neurology clinical skills examination

    PubMed Central

    Schuh, L A.; London, Z; Neel, R; Brock, C; Kissela, B M.; Schultz, L; Gelb, D J.

    2009-01-01

    Objective: The American Board of Psychiatry and Neurology (ABPN) has recently replaced the traditional, centralized oral examination with the locally administered Neurology Clinical Skills Examination (NEX). The ABPN postulated the experience with the NEX would be similar to the Mini-Clinical Evaluation Exercise, a reliable and valid assessment tool. The reliability and validity of the NEX has not been established. Methods: NEX encounters were videotaped at 4 neurology programs. Local faculty and ABPN examiners graded the encounters using 2 different evaluation forms: an ABPN form and one with a contracted rating scale. Some NEX encounters were purposely failed by residents. Cohen’s kappa and intraclass correlation coefficients (ICC) were calculated for local vs ABPN examiners. Results: Ninety-eight videotaped NEX encounters of 32 residents were evaluated by 20 local faculty evaluators and 18 ABPN examiners. The interrater reliability for a determination of pass vs fail for each encounter was poor (kappa 0.32; 95% confidence interval [CI] = 0.11, 0.53). ICC between local faculty and ABPN examiners for each performance rating on the ABPN NEX form was poor to moderate (ICC range 0.14-0.44), and did not improve with the contracted rating form (ICC range 0.09-0.36). ABPN examiners were more likely than local examiners to fail residents. Conclusions: There is poor interrater reliability between local faculty and American Board of Psychiatry and Neurology examiners. A bias was detected for favorable assessment locally, which is concerning for the validity of the examination. Further study is needed to assess whether training can improve interrater reliability and offset bias. GLOSSARY ABIM = American Board of Internal Medicine; ABPN = American Board of Psychiatry and Neurology; CI = confidence interval; HFH = Henry Ford Hospital; ICC = intraclass correlation coefficients; IM = internal medicine; mini-CEX = Mini-Clinical Evaluation Exercise; NEX = Neurology Clinical

  16. Malaria infection, poor nutrition and indoor air pollution mediate socioeconomic differences in adverse pregnancy outcomes in Cape Coast, Ghana.

    PubMed

    Amegah, Adeladza K; Damptey, Obed K; Sarpong, Gideon A; Duah, Emmanuel; Vervoorn, David J; Jaakkola, Jouni J K

    2013-01-01

    The epidemiological evidence linking socioeconomic deprivation with adverse pregnancy outcomes has been conflicting mainly due to poor measurement of socioeconomic status (SES). Studies have also failed to evaluate the plausible pathways through which socioeconomic disadvantage impacts on pregnancy outcomes. We investigated the importance of maternal SES as determinant of birth weight and gestational duration in an urban area and evaluated main causal pathways for the influence of SES. A population-based cross-sectional study was conducted among 559 mothers accessing postnatal services at the four main health facilities in Cape Coast, Ghana in 2011. Information on socioeconomic characteristics of the mothers was collected in a structured questionnaire. In multivariate linear regression adjusting for maternal age, parity and gender of newborn, low SES resulted in 292 g (95% CI: 440-145) reduction in birth weight. Important SES-related determinants were neighborhood poverty (221 g; 95% CI: 355-87), low education (187 g; 95% CI: 355-20), studentship during pregnancy (291 g; 95% CI: 506-76) and low income (147 g; 95% CI: 277-17). In causal pathway analysis, malaria infection (6-20%), poor nutrition (2-51%) and indoor air pollution (10-62%) mediated substantial proportions of the observed effects of socioeconomic deprivation on birth weight. Generalized linear models adjusting for confounders indicated a 218% (RR: 3.18; 95% CI: 1.41-7.21) risk increase of LBW and 83% (RR: 1.83; 95% CI: 1.31-2.56) of PTB among low income mothers. Low and middle SES was associated with 357% (RR: 4.57; 95% CI: 1.67-12.49) and 278% (RR: 3.78; 95% CI: 1.39-10.27) increased risk of LBW respectively. Malaria infection, poor nutrition and indoor air pollution respectively mediated 10-21%, 16-44% and 31-52% of the observed effects of socioeconomic disadvantage on LBW risk. We provide evidence of the effects of socioeconomic deprivation, substantially mediated by malaria infection, poor nutrition

  17. Outcome Measures for Clinical Trials in Down Syndrome

    PubMed Central

    Esbensen, Anna J.; Hooper, Stephen R.; Fidler, Deborah; Hartley, Sigan; Edgin, Jamie; d’Ardhuy, Xavier Liogier; Capone, George; Conners, Frances; Mervis, Carolyn B.; Abbeduto, Leonard; Rafii, Michael; Krinsky-McHale, Sharon J.; Urv, Tiina

    2017-01-01

    Increasingly individuals with intellectual and developmental disabilities, including Down syndrome, are being targeted for clinical trials. However, a challenge exists in effectively evaluating the outcomes of these new pharmacological interventions. Few empirically evaluated, psychometrically sound outcome measures appropriate for use in clinical trials with individuals with Down syndrome have been identified. To address this challenge, the NIH assembled leading clinicians and scientists to review existing measures and identify those that currently are appropriate for trials; those that may be appropriate after expansion of age range addition of easier items, and/or downward extension of psychometric norms; and areas where new measures need to be developed. This paper focuses on measures in the areas of cognition and behavior. PMID:28452584

  18. Clinical characteristics and outcomes of septic bursitis.

    PubMed

    Lieber, Sarah B; Fowler, Mary Louise; Zhu, Clara; Moore, Andrew; Shmerling, Robert H; Paz, Ziv

    2017-12-01

    Limited data guide practice in evaluation and treatment of septic bursitis. We aimed to characterize clinical characteristics, microbiology, and outcomes of patients with septic bursitis stratified by bursal involvement, presence of trauma, and management type. We conducted a retrospective cohort study of adult patients admitted to a single center from 1998 to 2015 with culture-proven olecranon and patellar septic bursitis. Baseline characteristics, clinical features, microbial profiles, operative interventions, hospitalization lengths, and 60-day readmission rates were determined. Patients were stratified by bursitis site, presence or absence of trauma, and operative or non-operative management. Of 44 cases of septic bursitis, patients with olecranon and patellar bursitis were similar with respect to age, male predominance, and frequency of bursal trauma; patients managed operatively were younger (p = 0.05). Clinical features at presentation and comorbidities were similar despite bursitis site, history of trauma, or management. The most common organism isolated from bursal fluid was Staphylococcus aureus. Patients managed operatively were discharged to rehabilitation less frequently (p = 0.04). This study of septic bursitis is among the largest reported. We were unable to identify presenting clinical features that differentiated patients treated surgically from those treated conservatively. There was no clear relationship between preceding trauma or bursitis site and clinical course, management, or outcomes. Patients with bursitis treated surgically were younger. Additional study is needed to identify patients who would benefit from early surgical intervention for septic bursitis.

  19. Functional Impairment and Occupational Outcome in Adults with ADHD

    ERIC Educational Resources Information Center

    Gjervan, Bjorn; Torgersen, Terje; Nordahl, Hans M.; Rasmussen, Kirsten

    2012-01-01

    Objective: ADHD is associated with poor functional outcomes. The objectives were to investigate the prevalence of functional impairment and occupational status in a clinically referred sample of adults with ADHD and explore factors predicting occupational outcome. Method: A sample of 149 adults with a confirmed diagnosis of ADHD participated in…

  20. Poor oral health including active caries in 187 UK professional male football players: clinical dental examination performed by dentists.

    PubMed

    Needleman, Ian; Ashley, Paul; Meehan, Lyndon; Petrie, Aviva; Weiler, Richard; McNally, Steve; Ayer, Chris; Hanna, Rob; Hunt, Ian; Kell, Steven; Ridgewell, Paul; Taylor, Russell

    2016-01-01

    The few studies that have assessed oral health in professional/elite football suggest poor oral health with minimal data on impact on performance. The aim of this research was to determine oral health in a representative sample of professional footballers in the UK and investigate possible determinants of oral health and self-reported impact on well-being, training and performance. Clinical oral health examination of senior squad players using standard methods and outcomes carried out at club training facilities. Questionnaire data were also collected. 8 teams were included, 5 Premier League, 2 Championship and 1 League One. 6 dentists examined 187 players who represented >90% of each senior squad. Oral health was poor: 37% players had active dental caries, 53% dental erosion and 5% moderate-severe irreversible periodontal disease. 45% were bothered by their oral health, 20% reported an impact on their quality of life and 7% on training or performance. Despite attendance for dental check-ups, oral health deteriorated with age. This is the first large, representative sample study in professional football. Oral health of professional footballers is poor, and this impacts on well-being and performance. Successful strategies to promote oral health within professional football are urgently needed, and research should investigate models based on best evidence for behaviour change and implementation science. Furthermore, this study provides strong evidence to support oral health screening within professional football. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

  1. Transdermal testosterone pretreatment in poor responders undergoing ICSI: a randomized clinical trial.

    PubMed

    Bosdou, J K; Venetis, C A; Dafopoulos, K; Zepiridis, L; Chatzimeletiou, K; Anifandis, G; Mitsoli, A; Makedos, A; Messinis, I E; Tarlatzis, B C; Kolibianakis, E M

    2016-05-01

    [median (interquartile range)] was similar between the groups compared [12.5 (3.0) days versus 12 (3.0) days, respectively, ITALIC! P = 0.52]. The number of COCs retrieved [median (interquartile range)] was not different between the testosterone pretreatment and the no pretreatment groups [3.5 (4.0) versus 3.0 (3.0), 95% CI for the median: 2.0-5.0 versus 2.7-4.3, respectively; difference between medians: 0.0, 95% CI: +1.0 to -1.0). Similarly no differences were observed regarding fertilization rates [median (interquartile range)] [66.7% (32.5) versus 66.7% (42.9), respectively, ITALIC! P = 0.97] and live birth rates per randomized patient (7.7% versus 8.3%, respectively, rate difference: -0.6%, 95% CI: -19.0 to +16.9). The study was not powered to detect differences less than 1.5 COCs, although it is doubtful whether these differences would be clinically relevant. Moreover, due to sample size restrictions, no conclusions can be drawn regarding the probability of live birth. The results of this randomized clinical trial, suggesting that pretreatment with 10 mg of transdermal testosterone for 21 days does not improve ovarian response by more than 1.5 oocytes, could be used to more accurately consult patients with poor ovarian response. However, an improvement in IVF outcome using a higher dose of testosterone or a longer pretreatment period cannot be excluded. The study was partially funded by a Scholarship from the Academy of Athens. C.A.V. reports personal fees and non-financial support from Merck, Sharp and Dome, personal fees and non-financial support from Merck Serono, personal fees and non-financial support from IPSEN Hellas S.A., outside the submitted work. B.C.T. reports grants from Merck Serono, grants from Merck Sharp & Dohme, personal fees from Merck Serono, personal fees from Merck Sharp & Dohme, personal fees from IBSA & Ferring, outside the submitted work. NCT01961336. 10 October 2013. 02/2014. © The Author 2016. Published by Oxford University Press on behalf

  2. Poor Cognitive Inhibition Predicts Rumination About Insomnia in a Clinical Sample.

    PubMed

    Ballesio, Andrea; Ottaviani, Cristina; Lombardo, Caterina

    2018-04-20

    According to the Cognitive Model of Insomnia disorder, rumination about lack of sleep and its diurnal consequences plays a crucial role in maintaining insomnia. Consolidated evidence shows that rumination is related to poor executive functions, which are cognitive control processes impacted by insomnia. Despite this evidence, no studies so far investigated the relationship between executive functions and rumination in individuals with insomnia. The aim of this pilot study was to cover this gap by investigating whether poor executive functions are associated with rumination in a sample of individuals with a diagnosis of insomnia disorder. Thirty young adults (22.67 ± 3.68 years, 73.3% females) diagnosed with insomnia disorder by clinical psychologists with expertise in behavioral sleep medicine completed the study. Measures of insomnia, depression, emotion regulation, and rumination about the daytime consequences of insomnia were collected. Executive functions were assessed using a Task Switching paradigm, measuring cognitive inhibition and set-shifting with cognitive flexibility. Hierarchical multiple regression analysis revealed that higher depression (β = 0.781, p < 0.001) and cognitive reappraisal (β = 0.329, p = 0.016), and poorer cognitive inhibition (β = -0.334, p = 0.014), significantly predicted higher rumination. Rumination about symptoms of insomnia in a clinical sample is associated with impaired inhibitory but not switching capacities above and beyond the role played by traditional predictors such as depression and emotion regulation strategies. If replicated, present preliminary results suggest the need to target cognitive inhibition deficits in insomnia treatment.

  3. Influence of Body Mass Index and Albumin on Perioperative Morbidity and Clinical Outcomes in Resected Pancreatic Adenocarcinoma

    PubMed Central

    Hendifar, Andrew; Osipov, Arsen; Khanuja, Jasleen; Nissen, Nicholas; Naziri, Jason; Yang, Wensha; Li, Quanlin; Tuli, Richard

    2016-01-01

    Obesity is a known risk factor for PDA and recent reports suggest obesity has a negative impact on clinical outcomes in patients with PDA. Pretreatment body mass index (BMI) and serum albumin (SA) have been shown to be associated with worse overall survival in patients with advanced and metastatic PDA. However, minimal data exists on the impact of BMI and SA on perioperative and long-term clinical outcomes in patients with early-stage resected PDA. Herein, we report on the impact of these variables on perioperative clinical outcomes, overall survival (OS) and disease free survival (DFS) in patients with resected PDA. With IRB approval, we evaluated 1,545 patients with PDA treated at a single institution from 2007–2013 and identified 106 patients who underwent upfront resection with curative intent. BMI and SA were calculated preoperatively and at the time of last clinical evaluation. Influence of preoperative BMI, SA, change in either variable, and influence of other clinical and pathologic variables on perioperative morbidity and mortality was assessed. The impact of these variables on DFS and OS was assessed with cox regression modeling and ANOVA. Actuarial estimates for DFS and OS were calculated using Kaplan-Meier methods. Median follow up time was 16 months (3–89). Mean age was 68 years. Median survival was 14 months (3–65) and median time to recurrence was 11 months (1–79). Length of hospital stay was associated with BMI (p = .023), change in BMI (p = .003) and SA (p = .004). Post-operative transfusion rate was associated with SA (p = .021). There was a strong correlation between BMI change and positive margin (p = .04) and lymph node status (p = .01). On multivariate analysis, change in SA (p = .03) and node positivity (p = .008) were associated with decreased DFS. Additionally, preoperative SA (p = .023), node positivity (p = .026) and poor differentiation (p = .045) were associated with worse OS on multivariate analysis. Low preoperative SA was

  4. Influence of Body Mass Index and Albumin on Perioperative Morbidity and Clinical Outcomes in Resected Pancreatic Adenocarcinoma.

    PubMed

    Hendifar, Andrew; Osipov, Arsen; Khanuja, Jasleen; Nissen, Nicholas; Naziri, Jason; Yang, Wensha; Li, Quanlin; Tuli, Richard

    2016-01-01

    Obesity is a known risk factor for PDA and recent reports suggest obesity has a negative impact on clinical outcomes in patients with PDA. Pretreatment body mass index (BMI) and serum albumin (SA) have been shown to be associated with worse overall survival in patients with advanced and metastatic PDA. However, minimal data exists on the impact of BMI and SA on perioperative and long-term clinical outcomes in patients with early-stage resected PDA. Herein, we report on the impact of these variables on perioperative clinical outcomes, overall survival (OS) and disease free survival (DFS) in patients with resected PDA. With IRB approval, we evaluated 1,545 patients with PDA treated at a single institution from 2007-2013 and identified 106 patients who underwent upfront resection with curative intent. BMI and SA were calculated preoperatively and at the time of last clinical evaluation. Influence of preoperative BMI, SA, change in either variable, and influence of other clinical and pathologic variables on perioperative morbidity and mortality was assessed. The impact of these variables on DFS and OS was assessed with cox regression modeling and ANOVA. Actuarial estimates for DFS and OS were calculated using Kaplan-Meier methods. Median follow up time was 16 months (3-89). Mean age was 68 years. Median survival was 14 months (3-65) and median time to recurrence was 11 months (1-79). Length of hospital stay was associated with BMI (p = .023), change in BMI (p = .003) and SA (p = .004). Post-operative transfusion rate was associated with SA (p = .021). There was a strong correlation between BMI change and positive margin (p = .04) and lymph node status (p = .01). On multivariate analysis, change in SA (p = .03) and node positivity (p = .008) were associated with decreased DFS. Additionally, preoperative SA (p = .023), node positivity (p = .026) and poor differentiation (p = .045) were associated with worse OS on multivariate analysis. Low preoperative SA was associated

  5. A qualitative study on why did the poorly-educated Chinese elderly fail to attend nurse-led case manager clinic and how to facilitate their attendance.

    PubMed

    Hung, Susanna Lok Lam; Fu, Sau Nga; Lau, Po Shan; Wong, Samuel Yeung Shan

    2015-01-31

    This study explored the views, barriers and facilitators of the poorly-educated elderly who were non-attendee of the nurse-led case manager clinic. The case managers provide assessment for diabetes complication screening and can refer patients to the appropriate multidisciplinary team in public outpatient primary care setting. We adopted qualitative research method by individual semi-structured face to face interviews. Nineteen Chinese type 2 diabetes mellitus subjects aged ≥ 60 who failed to attend the nurse-led case manager clinic were interviewed. They all came from a socially deprived urban district in Hong Kong. Content and thematic analysis was performed. Seven men and twelve women aged 60 to 89 were interviewed. Nine of them received no formal education and ten of them attended up to primary school. The reasons for non-attendance included attitude and poor knowledge towards diabetes complication screening and confusion of the nurse-led clinic as an educational talk. Most respondents could not understand the reason for the screening of diabetic complications, the concept of multidisciplinary care and the procedure and outcomes of nurse assessment. Five respondents were unable to follow multiple appointments because they could not read. Other reasons included physical barriers and comorbidity, family and financial constraint. They either had a tight daily schedule because of the need to take care of family members, or the family members who brought them to clinic had difficulty in attending multiple appointments. Enhanced understanding of the importance and procedure of diabetes multidisciplinary management, a flexible appointment system and a single clear appointment sheet may facilitate their attendance. Poorly-educated Chinese elderly with DM and their care givers faced physical, social and psychological barriers when attending the nurse-led case manager clinic. Strategies targeting on their low literacy include effective communication and education

  6. Validation of the Italian version of the Clinical Outcomes in Routine Evaluation Outcome Measure (CORE-OM).

    PubMed

    Palmieri, Gaspare; Evans, Chris; Hansen, Vidje; Brancaleoni, Greta; Ferrari, Silvia; Porcelli, Piero; Reitano, Francesco; Rigatelli, Marco

    2009-01-01

    The Clinical Outcomes in Routine Evaluation--Outcome Measure (CORE-OM) was translated into Italian and tested in non-clinical (n = 263) and clinical (n = 647) samples. The translation showed good acceptability, internal consistency and convergent validity in both samples. There were large and statistically significant differences between clinical and non-clinical datasets on all scores. The reliable change criteria were similar to those for the UK referential data. Some of the clinically significant change criteria, particularly for the men, were moderately different from the UK cutting points. The Italian version of the CORE-OM showed respectable psychometric parameters. However, it seemed plausible that non-clinical and clinical distributions of self-report scores on psychopathology and functioning measures may differ by language and culture. *A good quality Italian translation of the CORE-OM, and hence the GP-CORE, CORE-10 and CORE-5 measures also, is now available for use by practitioners and anyone surveying or exploring general psychological state. The measures can be obtained from CORE-IMS or yourself and practitioners are encouraged to share anonymised data so that good clinical and non-clinical referential databases can be established for Italy.

  7. Cycle cancellation and pregnancy after luteal estradiol priming in women defined as poor responders: a systematic review and meta-analysis

    PubMed Central

    Reynolds, Kasey A.; Omurtag, Kenan R.; Jimenez, Patricia T.; Rhee, Julie S.; Tuuli, Method G.; Jungheim, Emily S.

    2013-01-01

    STUDY QUESTION Does a luteal estradiol (LE) stimulation protocol improve outcomes in poor responders to IVF? SUMMARY ANSWER LE priming is associated with decreased cycle cancellation and increased chance of clinical pregnancy in poor responders WHAT IS KNOWN ALREADY Poor responders to IVF are one of the most challenging patient populations to treat. Many standard protocols currently exist for stimulating these patients but all have failed to improve outcomes. STUDY DESIGN, SIZE, DURATION Systematic review and meta-analysis including eight published studies comparing assisted reproduction technology (ART) outcomes in poor responders exposed to controlled ovarian hyperstimulation with and without LE priming. A search of the databases MEDLINE, EMBASE and PUBMED was carried out for studies in the English language published up to January 2012. PARTICIPANTS/MATERIALS, SETTING, METHODS Studies evaluating women defined as poor responders to ART were evaluated. These studies were identified following a systematic review of the literature and data were analyzed using the DerSimonian–Laird random effects model. The main outcomes of interest were cycle cancellation rate and clinical pregnancy. Although the definition of clinical pregnancy varied between studies, the principal definition included fetal cardiac activity as assessed by transvaginal ultrasonography after 5 weeks of gestation. MAIN RESULTS AND THE ROLE OF CHANCE A total of 2249 publications were identified from the initial search, and the bibliographies, abstracts and other sources yielded 11 more. After excluding duplications, 1227 studies remained and 8 ultimately met the inclusion criteria. Compared with women undergoing non-LE primed protocols (n = 621), women exposed to LE priming (n = 468) had a lower risk of cycle cancellation [relative risk (RR): 0.60, 95% confidence interval (CI): 0.45–0.78] and an improved chance of clinical pregnancy (RR: 1.33, 95% CI: 1.02–1.72). There was no significant

  8. Ultraearly assessed reperfusion status after middle cerebral artery recanalization predicting clinical outcome.

    PubMed

    Gölitz, P; Muehlen, I; Gerner, S T; Knossalla, F; Doerfler, A

    2018-06-01

    Mechanical thrombectomy has high evidence in stroke therapy; however, successful recanalization guarantees not a favorable clinical outcome. We aimed to quantitatively assess the reperfusion status ultraearly after successful middle cerebral artery (MCA) recanalization to identify flow parameters that potentially allow predicting clinical outcome. Sixty-seven stroke patients with acute MCA occlusion, undergoing recanalization, were enrolled. Using parametric color coding, a post-processing algorithm, pre-, and post-interventional digital subtraction angiography series were evaluated concerning the following parameters: pre- and post-procedural cortical relative time to peak (rTTP) of MCA territory, reperfusion time, and index. Functional long-term outcome was assessed by the 90-day modified Rankin Scale score (mRS; favorable: 0-2). Cortical rTTP was significantly shorter before (3.33 ± 1.36 seconds; P = .03) and after intervention (2.05 ± 0.70 seconds; P = .003) in patients with favorable clinical outcome. Additionally, age (P = .005) and initial National Institutes of Health Stroke Scale score (P = .02) were significantly different between the patients, whereas reperfusion index and time as well as initially estimated infarct size were not. In multivariate analysis, only post-procedural rTTP (P = .005) was independently associated with favorable clinical outcome. 2.29 seconds for post-procedural rTTP might be a threshold to predict favorable clinical outcome. Ultraearly quantitative assessment of reperfusion status after successful MCA recanalization reveals post-procedural cortical rTTP as possible independent prognostic value in predicting favorable clinical outcome, even determining a threshold value might be possible. In consequence, focusing stroke therapy on microcirculatory patency could be valuable to improve outcome. © 2018 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

  9. Computed tomography and clinical outcome in patients with severe traumatic brain injury.

    PubMed

    Stenberg, Maud; Koskinen, Lars-Owe D; Jonasson, Per; Levi, Richard; Stålnacke, Britt-Marie

    2017-01-01

    To study: (i) acute computed tomography (CT) characteristics and clinical outcome; (ii) clinical course and (iii) Corticosteroid Randomisation after Significant Head Injury acute calculator protocol (CRASH) model and clinical outcome in patients with severe traumatic brain injury (sTBI). Initial CT (CT i ) and CT 24 hours post-trauma (CT 24 ) were evaluated according to Marshall and Rotterdam classifications. Rancho Los Amigos Cognitive Scale-Revised (RLAS-R) and Glasgow Outcome Scale Extended (GOSE) were assessed at three months and one year post-trauma. The prognostic value of the CRASH model was evaluated. Thirty-seven patients were included. Marshall CT i and CT 24 were significantly correlated with RLAS-R at three months. Rotterdam CT 24 was significantly correlated with GOSE at three months. RLAS-R and the GOSE improved significantly from three months to one year. CRASH predicted unfavourable outcome at six months for 81% of patients with bad outcome and for 85% of patients with favourable outcome according to GOSE at one year. Neither CT nor CRASH yielded clinically useful predictions of outcome at one year post-injury. The study showed encouragingly many instances of significant recovery in this population of sTBI. The combination of lack of reliable prognostic indicators and favourable outcomes supports the case for intensive acute management and rehabilitation as the default protocol in the cases of sTBI.

  10. Risk Factors for Reporting Poor Cultural Competency Among Patients with Diabetes in Safety-Net Clinics

    PubMed Central

    Seligman, Hilary K.; Fernandez, Alicia; Stern, Rachel J.; Weech-Maldonado, Robert; Quan, Judy; Jacobs, Elizabeth A.

    2012-01-01

    Background The Consumer Assessment of Healthcare Providers and Systems Cultural Competency (CAHPS-CC) Item Set assesses patient perceptions of aspects of the cultural competence of their health care. Objective To determine characteristics of patients who identify the care they receive as less culturally competent Research Design Cross-sectional survey consisting of face-to-face interviews Subjects Safety-net population of patients with type 2 diabetes (n=600) receiving ongoing primary care Measures Participants completed the CAHPS-CC and answered questions about their race/ethnicity, gender, age, education, health status, depressive symptoms, insurance coverage, English proficiency, duration of relationship with primary care provider, and co-morbidities. Results In adjusted models, depressive symptoms were significantly associated with poor cultural competency in the Doctor Communication – Positive Behaviors domain (OR 1.73, 95%CI 1.11, 2.69). African-Americans were less likely than Whites to report poor cultural competence in the Doctor Communication – Positive Behaviors domain (OR 0.52, 0.28–0.97). Participants who reported a longer relationship (≥3 years) with their primary care provider were less likely to report poor cultural competence in the Doctor Communication – Health Promotion (OR 0.35, 0.21–0.60) and Trust domains (OR 0.4, 0.24–0.67), while participants with lower educational attainment were less likely to report poor cultural competence in the Trust domain (OR 0.51, 0.30–0.86). Overall, however, sociodemographic and clinical differences in reports of poor cultural competence were insignificant or inconsistent across the various domains of cultural competence examined. Conclusions Cultural competence interventions in safety-net settings should be implemented across populations, rather than being narrowly focused on specific sociodemographic or clinical groups. PMID:22895232

  11. Risk factors for reporting poor cultural competency among patients with diabetes in safety net clinics.

    PubMed

    Seligman, Hilary K; Fernandez, Alicia; Stern, Rachel J; Weech-Maldonado, Robert; Quan, Judy; Jacobs, Elizabeth A

    2012-09-01

    The Consumer Assessment of Healthcare Providers and Systems Cultural Competency Item Set assesses patient perceptions of aspects of the cultural competence of their health care. To determine characteristics of patients who identify the care they receive as less culturally competent. Cross-sectional survey consisting of face-to-face interviews. Safety-net population of patients with type 2 diabetes (n=600) receiving ongoing primary care. Participants completed the Consumer Assessment of Healthcare Providers and Systems Cultural Competency and answered questions about their race/ethnicity, sex, age, education, health status, depressive symptoms, insurance coverage, English proficiency, duration of relationship with primary care provider, and comorbidities. In adjusted models, depressive symptoms were significantly associated with poor cultural competency in the Doctor Communication--Positive Behaviors domain [odds ratio (OR) 1.73, 95% confidence interval, 1.11-2.69]. African Americans were less likely than whites to report poor cultural competence in the Doctor Communication--Positive Behaviors domain (OR 0.52, 95% CI, 0.28-0.97). Participants who reported a longer relationship (≥ 3 y) with their primary care provider were less likely to report poor cultural competence in the Doctor Communication--Health Promotion (OR 0.35, 95% CI, 0.21-0.60) and Trust domains (OR 0.4, 95% CI, 0.24-0.67), whereas participants with lower educational attainment were less likely to report poor cultural competence in the Trust domain (OR 0.51, 95% CI, 0.30-0.86). Overall, however, sociodemographic and clinical differences in reports of poor cultural competence were insignificant or inconsistent across the various domains of cultural competence examined. Cultural competence interventions in safety-net settings should be implemented across populations, rather than being narrowly focused on specific sociodemographic or clinical groups.

  12. Religion, Spirituality, and HIV Clinical Outcomes: A Systematic Review of the Literature.

    PubMed

    Doolittle, B R; Justice, A C; Fiellin, D A

    2018-06-01

    This systematic review evaluates the association between religion, spirituality and clinical outcomes in HIV-infected individuals. A systematic literature review was conducted for all English language articles published between 1980 and 2016 in relevant databases. Six hundred fourteen studies were evaluated. 15 met inclusion criteria. Ten (67%) studies reported a positive association between religion or spirituality and a clinical HIV outcome. Two (13%) studies failed to detect such an association; and two (13%) demonstrated a negative association. One study (7%) identified features of religiosity and spirituality that had both negative and positive associations with HIV clinical outcomes. Recognizing the religious or spiritual commitments of patients may serve as an important component of patient care. Further longitudinal studies and interventions might be required to further clarify the potential impact of religion and spirituality on HIV clinical outcomes.

  13. Wound-healing outcomes using standardized assessment and care in clinical practice.

    PubMed

    Bolton, Laura; McNees, Patrick; van Rijswijk, Lia; de Leon, Jean; Lyder, Courtney; Kobza, Laura; Edman, Kelly; Scheurich, Anne; Shannon, Ron; Toth, Michelle

    2004-01-01

    Wound-healing outcomes applying standardized protocols have typically been measured within controlled clinical trials, not natural settings. Standardized protocols of wound care have been validated for clinical use, creating an opportunity to measure the resulting outcomes. Wound-healing outcomes were explored during clinical use of standardized validated protocols of care based on patient and wound assessments. This was a prospective multicenter study of wound-healing outcomes management in real-world clinical practice. Healing outcomes from March 26 to October 31, 2001, were recorded on patients in 3 long-term care facilities, 1 long-term acute care hospital, and 12 home care agencies for wounds selected by staff to receive care based on computer-generated validated wound care algorithms. After diagnosis, wound dimensions and status were assessed using a tool adapted from the Pressure Sore Status Toolfor use on all wounds. Wound, ostomy, and continence nursing professionals accessed consistent protocols of care, via telemedicine in home care or paper forms in long-term care. A physician entered assessments into a desktop computer in the wound clinic. Based on evidence that healing proceeds faster with fewer infections in environments without gauze, the protocols generally avoided gauze dressings. Most of the 767 wounds selected to receive the standardized-protocols of care were stage III-IV pressure ulcers (n = 373; mean healing time 62 days) or full-thickness venous ulcers (n = 124; mean healing time 57 days). Partial-thickness wounds healed faster than same-etiology full-thickness wounds. These results provide benchmarks for natural-setting healing outcomes and help to define and address wound care challenges. Outcomes primarily using nongauze protocols of care matched or surpassed best previously published results on similar wounds using gauze-based protocols of care, including protocols applying gauze impregnated with growth factors or other agents.

  14. Application of WHO recommendations in outcome assessment of clinical series published in hand surgery journals with five years interval.

    PubMed

    Alarab, H; Dubert, T

    2015-02-01

    Outcome measurement is becoming increasingly important in hand surgery. The International classification of functioning, disability and health (ICF), is a WHO multi-dimensional approach to health condition including three domains: body "functions and structures", activities and participation. The aim of this study was to measure how often these three ICF domains were included in outcome measurements of the clinical series published in the American, European and French hand surgery journals. Our study included clinical series published in 2007 and 2012 in the American Journal Of Hand Surgery, European Journal Of Hand Surgery and Chirurgie de la Main. Analysis of each of these publications was done in two steps. First, we checked the presence or absence of the three domains of ICF in outcome measurement without considering the way it was measured. Then, we reported the use of evaluation instruments and/or quantitative measurement for each domain. We included 54 series in 2007 and 119 in 2012. The number of series reporting on the three domains and using at least one quantitative measurement for each domain represents 6% of articles in 2007 and 10% in 2012. This study shows that the quality of outcome measurement has improved over these 5 years, but remains poor according to the ICF recommendation. Copyright © 2015 Elsevier Masson SAS. All rights reserved.

  15. Low Birth Weight and Cognitive Outcomes: Evidence for a Gradient Relationship in an Urban, Poor, African American Birth Cohort

    ERIC Educational Resources Information Center

    Dombrowski, Stefan C.; Noonan, Kelly; Martin, Roy P.

    2007-01-01

    This study is one of the first to investigate the relationship between low birth weight and cognitive outcomes in an urban, poor, prospectively designed African-American birth cohort. Multivariate analyses of the Pathways to Adulthood study, a subset of the Johns Hopkins Collaborative Perinatal study, compared low birth weight African-American…

  16. Predictors of Clinical Outcomes in Sexually Abused Adolescents.

    PubMed

    Tocker, Lotem; Ben-Amitay, Galit; Horesh-Reinman, Netta; Lask, Michal; Toren, Paz

    2017-01-01

    This cross-sectional, case control study examines the association between child sexual abuse and interpersonal and intrapersonal outcomes among 54 adolescents, examining specific clinical measures (depression, anxiety, dissociation, and posttraumatic stress disorder, attachment patterns, self-esteem, self-disclosure, and family environment characteristics). The research results point to a correlation between sexual abuse and higher levels of the clinical measures. In addition, a correlation was found between sexual abuse and level of avoidant attachment, self-esteem, and family environment characteristics. Stepwise hierarchical regressions were conducted to examine how adolescent attributes predicted depression, anxiety, and dissociation beyond the prediction based on sexual abuse. A combination of self-esteem, anxiety attachment, and family cohesiveness made sexual abuse insignificant when predicting levels of depression, anxiety, and dissociation. This study contributes to characterizing the emotional, personal, and family attributes of adolescents who experienced sexual abuse. It also raises questions about the clinical outcomes usually associated with sexual abuse.

  17. Gender-related differences in clinical characteristics and outcomes in patients with diabetic ketoacidosis.

    PubMed

    Barski, Leonid; Harman-Boehm, Ilana; Nevzorov, Roman; Rabaev, Elena; Zektser, Miri; Jotkowitz, Alan B; Zeller, Lior; Shleyfer, Elena; Almog, Yaniv

    2011-12-01

    Diabetic ketoacidosis (DKA) is 1 of the most common and serious complications of diabetes, and is a significant cause of morbidity and mortality. There is a paucity of data regarding gender-related differences in clinical characteristics and outcomes of patients hospitalized for DKA. The purpose of this study was to assess whether gender plays a role in clinical characteristics and outcome of DKA. We performed a retrospective cohort study of patients hospitalized with DKA between January 1, 2003 and January 1, 2010. The outcomes of male and female patients were compared. The primary outcome was in-hospital all-cause mortality. The secondary outcomes were 30-day all-cause mortality and rate of complications: sepsis, respiratory failure, multiple organ failure, stroke, and myocardial infarction. Eighty-nine men and 131 women with DKA were included in the study. Male patients had higher rates of chronic renal failure compared with women (16.9% vs 3.1%; P = 0.001), whereas more women than men received oral hypoglycemic therapy (19.8% vs 9.0%; P = 0.046); women also had higher glycosated hemoglobin levels before admission (11.9% [1.7%] vs 9.9% [2.2%]; P = 0.025). The in-hospital mortality rate was not significantly different for both genders (4.5% in the male group vs 3.8% in the female group; P = 1.0). We did not find significant differences between the 2 groups in the 30-day mortality rate (4.5% vs 6.1%; P = 0.7) or the rate of complications (5.6% vs 6.9%; P = 0.9). Advanced age, mechanical ventilation, and bedridden state were independent predictors of 30-day mortality. In our study we did not find statistically significant differences in the in-hospital mortality, 30-day all-cause mortality, or rate of complications between men and women hospitalized with DKA. However, women with poorly controlled type 2 diabetes mellitus receiving oral hypoglycemic therapy required particular attention and might benefit from earlier introduction and intensification of insulin

  18. Sex differences in aneurysm morphologies and clinical outcomes in ruptured anterior communicating artery aneurysms: a retrospective study

    PubMed Central

    Lin, Boli; Chen, Weijian; Ruan, Lei; Chen, Yongchun; Zhong, Ming; Zhuge, Qichuan; Fan, Liang Hao; Zhao, Bing; Yang, Yunjun

    2016-01-01

    Objectives Ruptured anterior communicating artery (ACoA) aneurysms occur more frequently in men. The purpose of the study was to investigate sex difference in aneurysm morphologies and clinical outcomes in patients with ruptured ACoA aneurysms. Setting A tertiary referral hospital. Participants A total of 574 consecutive patients with ACoA aneurysms were admitted to our hospital from December 2007 to February 2015. In all, 474 patients (257 men and 217 women) with ruptured ACoA aneurysms were included in the study. Main outcome measures Aneurysm morphologies were measured using computed tomographic angiography and clinical outcomes were measured with Glasgow coma score at discharge. Results The aneurysm sizes (p=0.001), aneurysm heights (p=0.011), size ratios (p<0.001), flow angles (p=0.047) and vessel angles (p=0.046) were larger in the male patients than in the females. The female patients more often had larger vessel sizes (p=0.002). Multivariate logistic analysis revealed that significant differences in aneurysm morphologies between men and women were aneurysm size (OR 1.1, 95% CI 1.0 to 1.3; p=0.036), aneurysm height (OR 0.8, 95% CI 0. to 0.9; p=0.006) and size ratio (OR 1.4, 95% CI 0.5 to 1.7; p=0.001). There were no statistically significant differences in the outcomes between men and women (OR 1.0, 95% CI 0.6 to 1.7, p=0.857). Conclusions The men were independently associated with larger aneurysm sizes, greater aneurysm heights and larger size ratios. Sex was not a risk factor for poor outcome in patients with ruptured ACoA aneurysms. PMID:27084272

  19. Relationships between brain and body temperature, clinical and imaging outcomes after ischemic stroke

    PubMed Central

    Karaszewski, Bartosz; Carpenter, Trevor K; Thomas, Ralph G R; Armitage, Paul A; Lymer, Georgina Katherine S; Marshall, Ian; Dennis, Martin S; Wardlaw, Joanna M

    2013-01-01

    Pyrexia soon after stroke is associated with severe stroke and poor functional outcome. Few studies have assessed brain temperature after stroke in patients, so little is known of its associations with body temperature, stroke severity, or outcome. We measured temperatures in ischemic and normal-appearing brain using 1H-magnetic resonance spectroscopy and its correlations with body (tympanic) temperature measured four-hourly, infarct growth by 5 days, early neurologic (National Institute of Health Stroke Scale, NIHSS) and late functional outcome (death or dependency). Among 40 patients (mean age 73 years, median NIHSS 7, imaged at median 17 hours), temperature in ischemic brain was higher than in normal-appearing brain on admission (38.6°C-core, 37.9°C-contralateral hemisphere, P=0.03) but both were equally elevated by 5 days; both were higher than tympanic temperature. Ischemic lesion temperature was not associated with NIHSS or 3-month functional outcome; in contrast, higher contralateral normal-appearing brain temperature was associated with worse NIHSS, infarct expansion and poor functional outcome, similar to associations for tympanic temperature. We conclude that brain temperature is higher than body temperature; that elevated temperature in ischemic brain reflects a local tissue response to ischemia, whereas pyrexia reflects the systemic response to stroke, occurs later, and is associated with adverse outcomes. PMID:23571281

  20. Intracerebral hemorrhage location and outcome among INTERACT2 participants.

    PubMed

    Delcourt, Candice; Sato, Shoichiro; Zhang, Shihong; Sandset, Else Charlotte; Zheng, Danni; Chen, Xiaoying; Hackett, Maree L; Arima, Hisatomi; Hata, Jun; Heeley, Emma; Al-Shahi Salman, Rustam; Robinson, Thompson; Davies, Leo; Lavados, Pablo M; Lindley, Richard I; Stapf, Christian; Chalmers, John; Anderson, Craig S

    2017-04-11

    To clarify associations between intracerebral hemorrhage (ICH) location and clinical outcomes among participants of the main phase Intensive Blood Pressure Reduction in Acute Cerebral Hemorrhage Trial (INTERACT2). Associations between ICH sites and poor outcomes (death [6] or major disability [3-5] of modified Rankin Scale) and European Quality of Life Scale (EQ-5D) utility scores at 90 days were assessed in logistic regression models. Of 2,066 patients included in the analyses, associations were identified between ICH sites and poor outcomes: involvement of posterior limb of internal capsule increased risks of death or major disability (odds ratio [OR] 2.10) and disability (OR 1.81); thalamic involvement increased risks of death or major disability (OR 2.24) and death (OR 1.97). Involvement of the posterior limb of the internal capsule, thalamus, and infratentorial sites were each associated with poor EQ-5D utility score (≤0.7 [median]; OR 1.87, 2.14, and 2.81, respectively). Posterior limb of internal capsule involvement was strongly associated with low scores across all health-related quality of life domains. ICH encompassing the thalamus and posterior limb of internal capsule were associated with death or major disability, major disability, and poor EQ-5D utility score (OR 1.72, 2.26, and 1.71, respectively). Poor clinical outcomes are related to ICH affecting the posterior limb of internal capsule, thalamus, and infratentorial sites. The highest association with death or major disability and poor EQ-5D utility score was seen in ICH encompassing the thalamus and posterior limb of internal capsule. NCT00716079. Copyright © 2017 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of the American Academy of Neurology.

  1. Functional outcome of microsurgical clipping compared to endovascular coiling.

    PubMed

    Premananda, R M; Ramesh, N; Hillol, K P

    2012-12-01

    Endovascular coiling has been used increasingly as an alternative to neurosurgical clipping for treating subarachnoid hemorrhage secondary to aneurysm rupture. In a retrospective cohort review on the treatment methods of aneurysm rupture in Hospital Kuala Lumpur over the period of five years (2005-2009) a total of 268 patients were treated. These patients were broadly categorized into two groups based on their treatment mode for ruptured aneurysms. Statistical analysis was determined using Chi- Square tests to study these associations. In our study, 67.5% of patients presented with Good World Federation of Neurosurgical Societies (WFNS) grade (WFNS1-2) while 32.5% patients presented with Poor WFNS prior to intervention. In our outcome, it was noted that 60.4% had good functional outcome (mRS grade 0-2) as compared to 39.6% patients who had poor mRS(modified rankin scale) outcome (mRS 3-6). In the good WFNS group, 76% of patients in clipping group had a good mRS outcome while, 86.5% patients in coiling group had good mRS outcome (p=0.114). In poor WFNS presentation, it was noted that in 77.3% patients in clipping group, had poor mRS outcome. Similarly with poor WFNS presentation, 83.3% of patient in coiling group had poor outcome. (p=1.00). Hence when we control the WFNS group, there was no significant association between treatment group (clipping and coiling) and mRS outcome at 6 months. The outcome of patient is determined by initial clinical presentation (WFNS grade) and influenced by requirement of Extraventricular drain (EVD) in presence of hydrocephalus, CSF infection and pneumonia. Therefore the decision regarding treatment option needs to be individualized based on the presentation of the patient.

  2. Clinical outcome of Guillain-Barré syndrome after prolonged mechanical ventilation.

    PubMed

    van den Berg, Bianca; Storm, Eline F; Garssen, Marcel J P; Blomkwist-Markens, Patricia H; Jacobs, Bart C

    2018-04-07

    Patients with Guillain-Barré syndrome (GBS) may suffer from respiratory failure for months or longer. The aim of this study was to determine the frequency, clinical course and outcome of patients with GBS requiring prolonged mechanical ventilation (MV). Prospectively collected data from 526 patients with GBS participating in previous trials were analysed to determine the frequency and duration of prolonged MV (longer than 2 months). In addition, a cross-sectional study was conducted in patients with GBS requiring MV to determine the clinical course and long-term outcome with the ability to walk unaided as primary endpoint. In the cohort study, 145 of 526 patients with GBS (28%) required MV, including 33 (6%) patients with prolonged MV. Patients requiring prolonged MV had a lower Medical Research Council sum score and more frequent bulbar involvement and inexcitable nerves compared with shorter ventilated patients. At 6 months, 18% of patients with prolonged MV were able to walk unaided compared with 76% of patients requiring shorter MV (P<0.001). In the cross-sectional study, 63 patients requiring MV were included with a median follow-up of 11 years (range 2-44 years). Twenty-six (41%) of these patients needed prolonged MV (median 93 days, range 62-261). Fifteen (58%) of these patients were able to walk unaided at maximum follow-up and eight (31%) reached this endpoint more than 1 year after diagnosis. Prolonged ventilation in GBS is associated with poor prognosis, yet patients requiring prolonged ventilation may show slow but persistent recovery for years and even reach the ability to walk and live independently. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

  3. Outcome Measures for Clinical Trials in Down Syndrome.

    PubMed

    Esbensen, Anna J; Hooper, Stephen R; Fidler, Deborah; Hartley, Sigan L; Edgin, Jamie; d'Ardhuy, Xavier Liogier; Capone, George; Conners, Frances A; Mervis, Carolyn B; Abbeduto, Leonard; Rafii, Michael; Krinsky-McHale, Sharon J; Urv, Tiina

    2017-05-01

    Increasingly individuals with intellectual and developmental disabilities, including Down syndrome, are being targeted for clinical trials. However, a challenge exists in effectively evaluating the outcomes of these new pharmacological interventions. Few empirically evaluated, psychometrically sound outcome measures appropriate for use in clinical trials with individuals with Down syndrome have been identified. To address this challenge, the National Institutes of Health (NIH) assembled leading clinicians and scientists to review existing measures and identify those that currently are appropriate for trials; those that may be appropriate after expansion of age range addition of easier items, and/or downward extension of psychometric norms; and areas where new measures need to be developed. This article focuses on measures in the areas of cognition and behavior.

  4. Use of clinical and computed tomography findings to assess long-term unsatisfactory outcome after femoral head and neck ostectomy in four large breed dogs.

    PubMed

    Ober, Ciprian; Pestean, Cosmin; Bel, Lucia; Taulescu, Marian; Milgram, Joshua; Todor, Adrian; Ungur, Rodica; Leșu, Mirela; Oana, Liviu

    2018-05-10

    Femoral head and neck ostectomy (FHNO) is a salvage surgical procedure intended to eliminate hip joint laxity associated pain in the immature dog, or pain due to secondary osteoarthritis in the mature dog. The outcome of the procedure is associated with the size of the dog but the cause of a generally poorer outcome in larger breeds has not been determined. The objective of this study was to assess the long-term results of FHNO associated with unsatisfactory functional outcome by means of clinical examination and computed tomography (CT) scanning. Four large mixed breed dogs underwent FHNO in different veterinary clinics. Clinical and CT scanning evaluations were carried out long time after the procedures had been done. Hip pain, muscle atrophy, decreased range of motion and chronic lameness were observed at clinical examination. Extensive remodelling, unacceptable bone-on-bone contact with bony proliferation involving the femoral neck and acetabulum, but also excessive removal with bone lysis were observed by CT scanning. Revision osteotomy was performed in one dog. Deep gluteal muscle interposition was used, but no improvements were observed postoperatively. This is the first report on the evaluation of three-dimensional CT reconstructions of the late bone remodelling associated with poor clinical outcome in large dogs. The study shows that FHNO could lead to severe functional deficits in large breed dogs. An extensive follow-study is necessary to more accurately determine the frequency of such complications.

  5. Clinical outcomes of a 2-y soy isoflavone supplementation in menopausal women

    USDA-ARS?s Scientific Manuscript database

    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. Our aim was to evaluate the clinical outcomes of soy hypocoty...

  6. Poor cognitive outcome in shunt-responsive idiopathic normal pressure hydrocephalus.

    PubMed

    Koivisto, Anne M; Alafuzoff, Irina; Savolainen, Sakari; Sutela, Anna; Rummukainen, Jaana; Kurki, Mitja; Jääskeläinen, Juha E; Soininen, Hilkka; Rinne, Jaakko; Leinonen, Ville

    2013-01-01

    Idiopathic normal pressure hydrocephalus (iNPH) causes cognitive decline that can be alleviated by shunting, but long-term outcome studies are scarce. To elucidate the long-term cognitive condition of shunt-responsive iNPH patients. The follow-up data (Kuopio University Hospital NPH Registry) of 146 patients diagnosed with iNPH by clinical and radiological examination, 24-hour intraventricular pressure monitoring, frontal cortical biopsy, and response to the shunt were analyzed for signs of dementia. The Diagnostic and Statistical Manual for Mental Disorders, Fourth Edition, and specified memory disorder criteria were used. Median follow-up was 4.8 years. At the end of follow-up, 117 (80%) of the 146 iNPH patients had cognitive decline and 67 (46%) had clinical dementia. The most common clinical diagnoses were Alzheimer disease and vascular dementia. In multivariate analysis of the 146 iNPH patients, memory deficit as a first symptom before shunt (odds ratio [OR] 18.3; 95% confidence interval [CI] 1.9-175), male sex (OR 3.29; 95% CI 1.11-9.73), age (OR 1.17 year; 95% CI 1.07-1.28), and follow-up time (OR 1.20 year; 95% CI 1.02-1.40) predicted dementia. Interestingly, 8 (5%) iNPH patients had dementia without any signs of other neurodegenerative diseases in clinical, neuroradiological, or brain biopsy evaluation. These patients initially presented a full triad of symptoms, with gait disturbance being the most frequent initial symptom followed by deterioration in cognition. The novel findings were (a) a significant risk of dementia in iNPH initially responsive to cerebrospinal fluid shunt, (b) cognitive impairment most commonly due to iNPH-related dementia followed by concurrent degenerative brain disease, and (c) a subgroup with dementia related to iNPH without comorbidities.

  7. What predicts performance during clinical psychology training?

    PubMed

    Scior, Katrina; Bradley, Caroline E; Potts, Henry W W; Woolf, Katherine; de C Williams, Amanda C

    2014-06-01

    While the question of who is likely to be selected for clinical psychology training has been studied, evidence on performance during training is scant. This study explored data from seven consecutive intakes of the UK's largest clinical psychology training course, aiming to identify what factors predict better or poorer outcomes. Longitudinal cross-sectional study using prospective and retrospective data. Characteristics at application were analysed in relation to a range of in-course assessments for 274 trainee clinical psychologists who had completed or were in the final stage of their training. Trainees were diverse in age, pre-training experience, and academic performance at A-level (advanced level certificate required for university admission), but not in gender or ethnicity. Failure rates across the three performance domains (academic, clinical, research) were very low, suggesting that selection was successful in screening out less suitable candidates. Key predictors of good performance on the course were better A-levels and better degree class. Non-white students performed less well on two outcomes. Type and extent of pre-training clinical experience on outcomes had varied effects on outcome. Research supervisor ratings emerged as global indicators and predicted nearly all outcomes, but may have been biased as they were retrospective. Referee ratings predicted only one of the seven outcomes examined, and interview ratings predicted none of the outcomes. Predicting who will do well or poorly in clinical psychology training is complex. Interview and referee ratings may well be successful in screening out unsuitable candidates, but appear to be a poor guide to performance on the course. © 2013 The Authors. British Journal of Clinical Psychology published by John Wiley & Sons Ltd on behalf of the British Psychological Society.

  8. Invasive aspergillosis caused by Aspergillus terreus: an emerging opportunistic infection with poor outcome independent of azole therapy.

    PubMed

    Hachem, Ray; Gomes, Marisa Zenaide Ribeiro; El Helou, Gilbert; El Zakhem, Aline; Kassis, Christelle; Ramos, Elizabeth; Jiang, Ying; Chaftari, Anne-Marie; Raad, Issam I

    2014-11-01

    Invasive aspergillosis (IA) caused by Aspergillus terreus is a significant cause of morbidity and mortality in patients with haematological malignancy (HM). Very few data are available in this patient population to differentiate IA patients with A. terreus from those with non-terreus species of Aspergillus to compare outcomes. We retrospectively investigated 513 HM patients who were treated for either definite or probable IA between June 1993 and August 2012 in a cancer centre. We compared baseline characteristics, antifungal therapies and outcomes between patients infected with A. terreus (n = 96, 18.7%) and those infected with non-terreus Aspergillus species (n = 335, 65.3%). Eighty-one patients with mixed or unspecified Aspergillus infections were excluded. Breakthrough infections occurred more frequently in the A. terreus group (91% versus 77%, P = 0.009). A. terreus infection was associated with a lower rate of final response to antifungal therapy (21% versus 38%, P = 0.0015) and a higher rate of IA-associated mortality (51% versus 30%, P < 0.001). Multivariate analyses showed that these associations were independent of patients' clinical characteristics and the antifungal regimens they received. Factors independently associated with final response included treatment with azoles (OR 3.1, 95% CI 1.9-5.0, P < 0.0001) and Aspergillus species (A. terreus versus non-terreus Aspergillus species) (OR 0.5, 95% CI 0.3-0.98, P = 0.043). Additionally, Aspergillus species and treatment with azoles were independently associated with IA-associated mortality. A. terreus IA in HM patients was associated with worse outcome than IA caused by non-terreus Aspergillus species. Poor prognosis in patients with invasive A. terreus infections is independent of anti-Aspergillus azole-based treatment. Published by Oxford University Press on behalf of the British Society for Antimicrobial Chemotherapy 2014. This work is written by US Government employees and

  9. Clinical characteristics and outcome of management of Fournier's gangrene at the Lagos State University Teaching Hospital, Ikeja, Lagos, Nigeria.

    PubMed

    Omisanjo, Olufunmilade A; Bioku, M J; Ikuerowo, S O; Sule, G A; Esho, J O

    2014-01-01

    Fournier's gangrene (FG) though a rare condition can be associated with significant mortality. There are few reports in our environment documenting the outcome of management of the condition. The aim of the following study was to describe the clinical characteristics and outcome of management of patients with FG in a tertiary hospital in Southwest Nigeria. The clinical records of patients who presented with FG at a tertriary hospital over a 5 year period were reviewed. A total of 11 cases were reviewed and all patients were male. The scrotum alone was the most common site of involvement (54.5%). Late presentation was common with 9.6 days (range 1-21 days) being the average duration between the onset of symptoms and presentation at the hospital. Most of the patients (63.6%) did not have any identifiable systemic predisposing factor. There was no mortality or testicular loss recorded. Patients with FG still present late in our environment. However, appropriate aggressive treatment can help ameliorate the associated mortality and morbidity even in a resource poor setting.

  10. Prognostic factors and clinical outcomes in patients with leptomeningeal metastasis from solid tumors.

    PubMed

    Waki, Fusako; Ando, Masashi; Takashima, Atsuo; Yonemori, Kan; Nokihara, Hiroshi; Miyake, Mototaka; Tateishi, Ukihide; Tsuta, Koji; Shimada, Yasuhiro; Fujiwara, Yasuhiro; Tamura, Tomohide

    2009-06-01

    Leptomeningeal metastasis (LM) occurs in 4-15% of patients with solid tumors. Although the clinical outcomes in cancer patients have been improving recently, no standard treatment for LM has been established as yet. The purpose of this study was to identify the prognostic factors in patients with solid tumors with cytologically proven LM. We retrospectively analyzed a series of 85 consecutive patients with cytologically proven LM who were treated between 1997 and 2005. The primary diseases were as follows; lung cancer (n = 36), breast cancer (n = 33), gastric cancer (n = 8), and others (n = 8). Forty-nine patients had brain metastasis at the time of diagnosis of the LM, and in 51 patients, MRI revealed meningeal dissemination in the brain or spine. The performance status (PS) was 0-1 in 26 patients and 2-4 in 59 patients. Thirty-one patients, including 19 with breast cancer, four with lung cancer, five with gastric cancer and three with other cancers, were treated by intrathecal (IT) chemotherapy. The response rate to the IT was 52% (95% confidence interval (CI): 41.4-62.6%). The median survival was 51 days (range, 3-759 days). A univariate analysis identified breast cancer, good PS (0-1), time to development of the LM (>1 year), and treatment by IT chemotherapy as being associated with a good prognosis, and multivariate analysis identified poor PS (HR: 1.72 (95% CI, 1.04-2.86) P = 0.04) and MRI-proven LM (HR: 1.82 (95% CI, 1.11-2.98) P = 0.02) as being associated with a poor prognosis. In patients with poor prognostic factors, such as poor PS or MRI-proven LM, palliative therapy might be the most suitable treatment strategy.

  11. Clinical and Polysomnographic Predictors of the Natural History of Poor Sleep in the General Population

    PubMed Central

    Fernandez-Mendoza, Julio; Vgontzas, Alexandros N.; Bixler, Edward O.; Singareddy, Ravi; Shaffer, Michele L.; Calhoun, Susan L.; Karataraki, Maria; Vela-Bueno, Antonio; Liao, Duanping

    2012-01-01

    Study Objectives: Approximately 8-10% of the general population suffers from chronic insomnia, whereas another 20-30% of the population has insomnia symptoms at any given time (i.e., poor sleep). However, few longitudinal studies have examined risk factors of the natural history of poor sleep, and none have examined the role of polysomnographic (PSG) variables. Design: Representative longitudinal study. Setting: Sleep laboratory. Participants: From a random, general population sample of 1,741 individuals of the adult Penn State Cohort, 1,395 were followed up after 7.5 yr. Measurements: Full medical evaluation and 1-night PSG at baseline and telephone interview at follow-up. Results: The rate of incident poor sleep was 18.4%. Physical (e.g., obesity, sleep apnea, and ulcer) and mental (e.g., depression) health conditions and behavioral factors (e.g., smoking and alcohol consumption) increased the odds of incident poor sleep as compared to normal sleep. The rates of persistent, remitted, and poor sleepers who developed chronic insomnia were 39%, 44%, and 17%, respectively. Risk factors for persistent poor sleep were physical health conditions combined with psychologic distress. Shorter objective sleep duration and a family history of sleep problems were risk factors for poor sleep evolving into chronic insomnia. Conclusions: Poor sleep appears to be primarily a symptom of physical and mental health conditions, whereas the persistence of poor sleep is associated with psychologic distress. Importantly, sleep apnea appears to be associated with incident poor sleep but not with chronic insomnia. Finally, this study suggests that objective short sleep duration in poor sleepers is a biologic marker of genetic predisposition to chronic insomnia. Citation: Fernandez-Mendoza J; Vgontzas AN; Bixler EO; Singareddy R; Shaffer ML; Calhoun SL; Karataraki M; Vela-Bueno A; Liao D. Clinical and polysomnographic predictors of the natural history of poor sleep in the general population

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

    PubMed

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

    2015-07-01

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

  13. Nonword repetition in children with cochlear implants: a potential clinical marker of poor language acquisition.

    PubMed

    Nittrouer, Susan; Caldwell-Tarr, Amanda; Sansom, Emily; Twersky, Jill; Lowenstein, Joanna H

    2014-11-01

    Cochlear implants (CIs) can facilitate the acquisition of spoken language for deaf children, but challenges remain. Language skills dependent on phonological sensitivity are most at risk for these children, so having an effective way to diagnose problems at this level would be of value for school speech-language pathologists. The goal of this study was to assess whether a nonword repetition (NWR) task could serve that purpose. Participants were 104 second graders: 49 with normal hearing (NH) and 55 with CIs. In addition to NWR, children were tested on 10 measures involving phonological awareness and processing, serial recall of words, vocabulary, reading, and grammar. Children with CIs performed more poorly than children with NH on NWR, and sensitivity to phonological structure alone explained that performance for children in both groups. For children with CIs, 2 audiological factors positively influenced outcomes on NWR: being identified with hearing loss at a younger age and having experience with wearing a hearing aid on the unimplanted ear at the time of receiving a 1st CI. NWR scores were better able to rule out than to rule in such language deficits. Well-designed NWR tasks could have clinical utility in assessments of language acquisition for school-age children with CIs.

  14. Nonword repetition in children with cochlear implants: A potential clinical marker of poor language acquisition

    PubMed Central

    Nittrouer, Susan; Caldwell-Tarr, Amanda; Sansom, Emily; Twersky, Jill; Lowenstein, Joanna H.

    2014-01-01

    Purpose Cochlear implants (CIs) can facilitate the acquisition of spoken language for deaf children, but challenges remain. Language skills dependent upon phonological sensitivity are most at risk for these children, so having an effective way to diagnose problems at this level would be of value for school speech-language pathologists. The goal of this study was to assess whether a nonword repetition (NWR) task could serve that purpose. Method 104 second graders participated: 49 with NH and 55 with CIs. In addition to NWR, children were tested on ten measures involving phonological awareness/processing, serial recall of words, vocabulary, reading, and grammar. Results Children with CIs performed more poorly than children with NH on NWR, and sensitivity to phonological structure alone explained that performance for children in both groups. For children with CIs, two audiological factors positively influenced outcomes on NWR: being identified with hearing loss at younger ages and having experience wearing a hearing aid on the unimplanted ear at the time of receiving a first CI. NWR scores were better able to rule out language deficits than rule in such deficits. Conclusions Well-designed NWR tasks could have clinical utility in assessments of language acquisition for school-age children with CIs. PMID:25340675

  15. Impact of locus of control on clinical outcomes in renal dialysis.

    PubMed

    Dec, Elaine

    2006-01-01

    This study focused on the relationship between patients' locus of control and their ability to improve selected clinical outcomes related to kidney dialysis. The main hypothesis of this study stated that patients who viewed themselves as having control over their situation would be more successful at improving targeted clinical outcomes than those who believed someone other than themselves had control over their situation. The study found that interventions aimed at increasing awareness of who has control and reducing the aspect of chance had a more significant positive impact on outcomes than did pure cognitive or educational interventions geared mainly toward emotional issues or educational deficits. Interventions that work with the dominant locus of control to increase awareness of where control lies appeared to be more effective in assisting the patients to improve their targeted clinical outcomes rather than are interventions to change the locus of control between internal and powerful others (external).

  16. Diabetes mellitus in patients with pulmonary tuberculosis in an aging population in Shanghai, China: Prevalence, clinical characteristics and outcomes.

    PubMed

    Wu, Zheyuan; Guo, Juntao; Huang, Ying; Cai, Enmao; Zhang, Xia; Pan, Qichao; Yuan, Zheng'an; Shen, Xin

    2016-03-01

    To determine the prevalence of diabetes mellitus among pulmonary tuberculosis patients and the difference of clinical characteristics and outcomes between pulmonary tuberculosis patients with and without diabetes mellitus in an aging population in Shanghai, China. This is a retrospective population-based study. 201 newly diagnosed pulmonary tuberculosis patients in Changning District, Shanghai during 2007-2008 were included. Clinical characteristics and outcomes were collected. Determination of diabetes mellitus was based on the medical records before pulmonary tuberculosis was diagnosed. The prevalence of diabetes mellitus among pulmonary tuberculosis patients was 19.9% (40/201). Pulmonary tuberculosis patients with diabetes mellitus were more likely to be old (≥50, OR=5.23, 95% CI=2.07-13.25), to have pulmonary cavities (OR=3.02, 95% CI=1.31-6.98), to be sputum smear positive (OR=2.90, 95% CI=1.12-7.51), and to have extension of anti-tuberculosis treatment duration (OR=2.68, 95% CI 1.17-6.14). Besides, they had a higher 2nd month sputum smear positive proportion (OR=2.97, 95% CI 1.22-7.22) and a higher 5-year recurrence rate (OR=5.87, 95% CI 1.26-27.40). High prevalence, severe clinical characteristics and poor outcomes of pulmonary tuberculosis patients with diabetes mellitus highlight the necessity of early bi-directional screening and co-management of these two diseases in Shanghai, China. Copyright © 2016 Elsevier Inc. All rights reserved.

  17. Persistent Dysphagia After Induction Chemotherapy in Patients with Esophageal Adenocarcinoma Predicts Poor Post-Operative Outcomes.

    PubMed

    McNamara, Michael J; Adelstein, David J; Allende, Daniela S; Bodmann, Joanna W; Ives, Denise I; Murthy, Sudish C; Raymond, Daniel; Raja, Siva; Rodriguez, Cristina P; Sohal, Davendra; Stephans, Kevin L; Videtic, Gregory M M; Rybicki, Lisa A

    2017-06-01

    Preoperative therapy is frequently employed in the management of esophageal adenocarcinoma. However, many patients are found to have advanced pathologic stage and have poor outcomes. A prognostic factor which identifies this patient population before surgery would be desirable, as alternative treatment strategies may be warranted. Between 2/08 and 1/12, 60 evaluable patients with locally advanced esophageal adenocarcinoma enrolled in single-arm phase II trial of induction chemotherapy, surgery, and post-operative adjuvant chemo-radiotherapy (CRT). A clinical stage of T3, N1, or M1a (AJCC 6th) was required for eligibility. Induction chemotherapy with epirubicin 50 mg/m 2 d1, oxaliplatin 130 mg/m 2 d1, and fluorouracil 200 mg/m 2 /day continuous infusion for 3 weeks, was given every 21 days for 3 cycles and was followed by surgical resection. Adjuvant CRT consisted of 50-55 Gy @ 1.8-2.0 Gy/day and 2 cycles of cisplatin (20 mg/m 2 /day) and fluorouracil (1000 mg/m 2 /day) given as 96-h infusions during weeks 1 and 4 of radiotherapy. Dysphagia was assessed at baseline and after induction chemotherapy. Persistent dysphagia was associated with worse distant metastatic control [HR 3.48 (1.43-8.43), p = 0.006], recurrence free survival [HR 3.04 (1.34-6.92), p = 0.008], and overall survival [HR 3.31 (1.43-7.66), p = 0.005]. Persistent dysphagia was associated with more advanced pathologic T descriptor (pT) (p = 0.048) and N descriptor (pN) (p = 0.002), a greater median number of involved lymph nodes (3 v 1, p = 0.003), and greater residual tumor viability (p = 0.05). No patients with persistent dysphagia had pT0-T2 or pN0 disease. Persistent dysphagia after induction chemotherapy is associated with more advanced pathologic stage and inferior outcomes.

  18. Magnetic resonance imaging of injuries to the ankle joint: can it predict clinical outcome?

    PubMed

    Zanetti, M; De Simoni, C; Wetz, H H; Zollinger, H; Hodler, J

    1997-02-01

    To predict clinical outcome after ankle sprains on the basis of magnetic resonance (MR) findings. Twenty-nine consecutive patients (mean age 32.9 years, range 13-60 years) were examined clinically and with MR imaging both after trauma and following standardized conservative therapy. Various MR abnormalities were related to a clinical outcome score. There was a tendency for a better clinical outcome in partial, rather than complete, tears of the anterior talofibular ligament and when there was no fluid within the peroneal tendon sheath at the initial MR examination (P = 0.092 for either abnormality). A number of other MR features did not significantly influence clinical outcome, including the presence of a calcaneofibular ligament lesion and a bone bruise of the talar dome. Clinical outcome after ankle sprain cannot consistently be predicted by MR imaging, although MR imaging may be more accurate when the anterior talofibular ligament is only partially torn and there are no signs of injury to the peroneal tendon sheath.

  19. The Clinical Features and Surgical Outcomes of Spinal Cord Tanycytic Ependymomas: A Report of 40 Cases.

    PubMed

    Tao, Xiaogang; Hou, Zonggang; Hao, Shuyu; Zhang, Qi; Wu, Zhen; Zhang, Junting; Liu, Baiyun

    2017-10-01

    Spinal cord tanycytic ependymomas (TEs) rarely are reported because of extremely low incidence. Understanding of this disease is therefore poor. The aim of this study was to analyze the incidence and clinical, radiologic, pathologic, and prognostic features of spinal cord TEs. Approximately 4000 spinal cord tumors were resected surgically in Beijing Tiantan Hospital between April 2009 and May 2016. We identified all cases of pathologically proved TEs among these patients. TEs accounted for approximately 1% of spinal cord tumors (40 of an estimated 4000). Patients with TE were a mean age of 40.0 years and had no significant sex preference (21 male and 19 female). The median diameter of the maximal tumor was 54.2 mm (range, 16-153 mm). The mean preoperative Japanese Orthopedic Association (JOA) score was 13.0. Radiologically, 47.5% (19/40) cases showed poorly defined tumor border, and 40% (16/40) of them showed preoperative syringomyelia. Gross total resection was achieved in 30 cases, subtotal resection in 8, and partial resection in 2. At the time of discharge, JOA score and neurologic function showed improvement in 26 cases (65%), no change in 12 cases (30%), and worsening in 2 cases (5%). At a median follow-up of 43 months (range, 7-101 months), 1- and 5-year progression-free survival rates were 100.0% and 97.5%, respectively. Only one patient had tumor recurrence which was found 30 months after surgery. No patient died of tumor recurrence. At the latest follow-up, JOA score showed improvement in 30 cases (75%), no change in 8 cases (20%), and worsening in 2 cases (5%). Univariate analysis revealed that tumor size and preoperative JOA score were significantly associated with the short-term outcomes. Meanwhile, age ≥40 years, tumor size ≥50 mm, non-gross total resection, and preoperative JOA score <14 were significantly associated with an increased risk of worsened long-term outcomes. Poorly defined tumor border and preoperative JOA score <14 significantly

  20. The factor structure and psychometric properties of the Clinical Outcomes in Routine Evaluation – Outcome Measure (CORE-OM) in Norwegian clinical and non-clinical samples

    PubMed Central

    2013-01-01

    Background The Clinical Outcomes in Routine Evaluation - Outcome Measure (CORE-OM) is a 34-item instrument developed to monitor clinically significant change in out-patients. The CORE-OM covers four domains: well-being, problems/symptoms, functioning and risk, and sums up in two total scores: the mean of All items, and the mean of All non-risk items. The aim of this study was to examine the psychometric properties of the Norwegian translation of the CORE-OM. Methods A clinical sample of 527 out-patients from North Norwegian specialist psychiatric services, and a non-clinical sample of 464 persons were obtained. The non-clinical sample was a convenience sample consisting of friends and family of health personnel, and of students of medicine and clinical psychology. Students also reported psychological stress. Exploratory factor analysis (EFA) was employed in half the clinical sample. Confirmatory (CFA) factor analyses modelling the theoretical sub-domains were performed in the remaining half of the clinical sample. Internal consistency, means, and gender and age differences were studied by comparing the clinical and non-clinical samples. Stability, effect of language (Norwegian versus English), and of psychological stress was studied in the sub-sample of students. Finally, cut-off scores were calculated, and distributions of scores were compared between clinical and non-clinical samples, and between students reporting stress or no stress. Results The results indicate that the CORE-OM both measures general (g) psychological distress and sub-domains, of which risk of harm separates most clearly from the g factor. Internal consistency, stability and cut-off scores compared well with the original English version. No, or only negligible, language effects were found. Gender differences were only found for the well-being domain in the non-clinical sample and for the risk domain in the clinical sample. Current patient status explained differences between clinical and non-clinical

  1. Progressive disability and prefrontal shrinkage in schizophrenia patients with poor outcome: A 3-year longitudinal study.

    PubMed

    Dusi, N; Bellani, M; Perlini, C; Squarcina, L; Marinelli, V; Finos, L; Altamura, C A; Ruggeri, M; Brambilla, P

    2017-01-01

    Schizophrenia is a severe disabling disorder with heterogeneous illness courses. In this longitudinal study we characterized schizophrenia patients with poor and good outcome (POS, GOS), using functional and imaging metrics. Patients were defined in accordance to Keefe's criteria (i.e. Kraepelinian and non-Kraepelinian patients). 35 POS patients, 35 GOS patients and 76 healthy controls (H) underwent clinical, functioning and magnetic resonance imaging (MRI) assessments twice over three years of follow-up. Information on psychopathology, treatment, disability (using the World Health Organization Disability Assessment Scale II, WHO-DAS-2) and prefrontal morphology was collected. Dorsolateral prefrontal cortex (DLPFC) and orbitofrontal cortex (OFC) were manually traced. At baseline, subjects with POS showed significantly decreased right dorsolateral prefrontal cortex (DLPFC) white matter volumes (WM) compared to healthy controls and GOS patients (POS VS HC, p<0.001; POS vs GOS, p=0.03), with shrinkage of left DLPFC WM volumes at follow up (t=2.66, p=0.01). Also, POS patients had higher disability in respect to GOS subjects both at baseline and after 3years at the WHO-DAS-2 (p<0.05). Our study supports the hypothesis that POS is characterized by progressive deficits in brain structure and in "real-life" functioning. These are particularly notable in the DLPFC. Copyright © 2016 Elsevier B.V. All rights reserved.

  2. Do mobile clinics provide high-quality antenatal care? A comparison of care delivery, knowledge outcomes and perception of quality of care between fixed and mobile clinics in central Haiti.

    PubMed

    Phillips, Erica; Stoltzfus, Rebecca J; Michaud, Lesly; Pierre, Gracia Lionel Fils; Vermeylen, Francoise; Pelletier, David

    2017-10-16

    Antenatal care (ANC) is an important health service for women in developing countries, with numerous proven benefits. Global coverage of ANC has steadily increased over the past 30 years, in part due to increased community-based outreach. However, commensurate improvements in health outcomes such as reductions in the prevalence of maternal anemia and infants born small-for-gestational age have not been achieved, even with increased coverage, indicating that quality of care may be inadequate. Mobile clinics are one community-based strategy used to further improve coverage of ANC, but their quality of care delivery has rarely been evaluated. To determine the quality of care of ANC in central Haiti, we compared adherence to national guidelines between fixed and mobile clinics by performing direct observations of antenatal care consultations and exit interviews with recipients of care using a multi-stage random sampling procedure. Outcome variables were eight components of care, and women's knowledge and perception of care quality. There were significant differences in the predicted proportion or probability of recommended services for four of eight care components, including intake, laboratory examinations, infection control, and supplies, iron folic acid supplements and Tetanus Toxoid vaccine provided to women. These care components were more likely performed in fixed clinics, except for distribution of supplies, iron-folic acid supplements, and Tetanus Toxoid vaccine, more likely provided in mobile clinics. There were no differences between clinic type for the proportion of total physical exam procedures performed, health and communication messages delivered, provider communication or documentation. Women's knowledge about educational topics was poor, but women perceived extremely high quality of care in both clinic models. Although adherence to guidelines differed by clinic type for half of the care components, both clinics had a low percentage of overall services

  3. Clinical and social outcomes of adolescent self harm: population based birth cohort study

    PubMed Central

    Heron, Jon; Crane, Catherine; Hawton, Keith; Lewis, Glyn; Macleod, John; Tilling, Kate; Gunnell, David

    2014-01-01

    Objectives To investigate the mental health, substance use, educational, and occupational outcomes of adolescents who self harm in a general population sample, and to examine whether these outcomes differ according to self reported suicidal intent. Design Population based birth cohort study. Setting Avon Longitudinal Study of Parents and Children (ALSPAC), a UK birth cohort of children born in 1991-92. Participants Data on lifetime history of self harm with and without suicidal intent were available for 4799 respondents who completed a detailed self harm questionnaire at age 16 years. Multiple imputation was used to account for missing data. Main outcome measures Mental health problems (depression and anxiety disorder), assessed using the clinical interview schedule-revised at age 18 years, self reported substance use (alcohol, cannabis, cigarette smoking, and illicit drugs) at age 18 years, educational attainment at age 16 and 19 years, occupational outcomes at age 19 years, and self harm at age 21 years. Results Participants who self harmed with and without suicidal intent at age 16 years were at increased risk of developing mental health problems, future self harm, and problem substance misuse, with stronger associations for suicidal self harm than for non-suicidal self harm. For example, in models adjusted for confounders the odds ratio for depression at age 18 years was 2.21 (95% confidence interval 1.55 to 3.15) in participants who had self harmed without suicidal intent at age 16 years and 3.94 (2.67 to 5.83) in those who had self harmed with suicidal intent. Suicidal self harm, but not self harm without suicidal intent, was also associated with poorer educational and employment outcomes. Conclusions Adolescents who self harm seem to be vulnerable to a range of adverse outcomes in early adulthood. Risks were generally stronger in those who had self harmed with suicidal intent, but outcomes were also poor among those who had self harmed without suicidal

  4. Prophylactic Antiepileptic Drug Use and Outcome in the Ethnic/Racial Variations of Intracerebral Hemorrhage Study.

    PubMed

    Sheth, Kevin N; Martini, Sharyl R; Moomaw, Charles J; Koch, Sebastian; Elkind, Mitchell S V; Sung, Gene; Kittner, Steven J; Frankel, Michael; Rosand, Jonathan; Langefeld, Carl D; Comeau, Mary E; Waddy, Salina P; Osborne, Jennifer; Woo, Daniel

    2015-12-01

    The role of antiepileptic drug (AED) prophylaxis after intracerebral hemorrhage (ICH) remains unclear. This analysis describes prevalence of prophylactic AED use, as directed by treating clinicians, in a prospective ICH cohort and tests the hypothesis that it is associated with poor outcome. Analysis included 744 patients with ICH enrolled in the Ethnic/Racial Variations of Intracerebral Hemorrhage (ERICH) study before November 2012. Baseline clinical characteristics and AED use were recorded in standardized fashion. ICH location and volume were recorded from baseline neuroimaging. We analyzed differences in patient characteristics by AED prophylaxis, and we used logistic regression to test whether AED prophylaxis was associated with poor outcome. The primary outcome was 3-month modified Rankin Scale score, with 4 to 6 considered poor outcome. AEDs were used for prophylaxis in 289 (39%) of the 744 subjects; of these, levetiracetam was used in 89%. Patients with lobar ICH, craniotomy, or larger hematomas were more likely to receive prophlyaxis. Although prophylactic AED use was associated with poor outcome in an unadjusted model (odds ratio, 1.40; 95% confidence interval, 1.04-1.88; P=0.03), this association was no longer significant after adjusting for clinical and demographic characteristics (odds ratio, 1.11; 95% confidence interval, 0.74-1.65; P=0.62). We found no evidence that AED use (predominantly levetiracetam) is independently associated with poor outcome. A prospective study is required to assess for a more modest effect of AED use on outcome after ICH. © 2015 American Heart Association, Inc.

  5. High-grade poorly differentiated neuroendocrine carcinoma of the breast with low oncotype Dx recurrence score: A case report.

    PubMed

    Munoz-Zuluaga, Carlos A; Kotiah, Sandy; Studeman, Kimberley D

    2017-01-01

    Primary neuroendocrine carcinoma of the breast (NECB) is a rare malignant tumor with controversial biological behavior and a lack of data guiding treatment decisions due to its scarcity. Cancer gene-expression profiling tests provide a better indication of clinical prognosis and help determine the best clinical management versus the traditional clinical and pathological parameters. This is a report of a NECB with a genetic assay that showed a low-risk tumor despite high-grade and poorly differentiated histopathological features. Patient outcomes correlate with the low risk classification without the need for adjuvant chemotherapy despite the standard clinical-pathologic approach. Analysis of cancer related genes expression and outcomes in historical NECB may elucidate new insight of this rare disease.

  6. Clinical Outcome Metrics for Optimization of Robust Training

    NASA Technical Reports Server (NTRS)

    Ebert, Doug; Byrne, Vicky; Cole, Richard; Dulchavsky, Scott; Foy, Millennia; Garcia, Kathleen; Gibson, Robert; Ham, David; Hurst, Victor; Kerstman, Eric; hide

    2015-01-01

    The objective of this research is to develop and use clinical outcome metrics and training tools to quantify the differences in performance of a physician vs non-physician crew medical officer (CMO) analogues during simulations.

  7. Impact of Patient Sex on Clinical Outcomes

    PubMed Central

    Teitsma, Xavier M.; van der Hoeven, Henk; Tamminga, Rob; de Bie, Rob A.

    2014-01-01

    Background: The Combined Quality Care Anterior Cruciate Ligament registry provides data for clinical research regarding primary anterior cruciate ligament (ACL) surgery. Purpose: To explore the data with regard to the clinical outcomes between sexes after ACL reconstruction in a Dutch population. Study Design: Cohort study; Level of evidence, 3. Methods: Data involving patients diagnosed with an ACL tear and eligible for surgery were recorded. Isokinetic muscle strength, functional muscle performance, and anterior-posterior translation of the knee joint were documented preoperatively and at 3, 6, 9, and 12 months postoperatively. Patients completed the Knee Injury and Osteoarthritis Outcome Score (KOOS), Lysholm, and Tegner rating scales during each examination using a web-based questionnaire. Results: Approximately 90% of ACL injuries occurred during sport activities. The mean (SD) age at surgery was 28 (11) years for both men and women, and the majority of patients were treated with hamstring tendon autografts (94%). Four percent received bone–patellar tendon–bone autografts, and 2% of the patients received other grafts. Preoperatively, the KOOS, Lysholm, and Tegner scores were significantly higher in males. Twelve months postoperatively, both sexes showed comparable isokinetic strength (P = .336), knee laxity (P = .680), and hop test for distance (P = .122) when comparing the injured with the uninjured side. Self-reported knee function was comparable between sexes as assessed by the KOOS (P = .202), Lysholm (P = .872), and Tegner (P = .767) questionnaires during the 12-month follow-up. Conclusion: One year after ACL surgery, all patients had improved greatly, showing only minor differences between sexes. The male group showed slightly better results when evaluating self-reported knee questionnaires. Comparable outcomes and knee function between sexes can therefore be presumed with patients who are treated with hamstring tendon autografts in a Dutch

  8. Mucinous Histology Signifies Poor Oncologic Outcome in Young Patients With Colorectal Cancer.

    PubMed

    Soliman, Basem G; Karagkounis, Georgios; Church, James M; Plesec, Thomas; Kalady, Matthew F

    2018-05-01

    The incidence of colorectal cancer in the young (under age 40) is increasing, and this population has worse oncologic outcomes. Mucinous histology is a potential prognostic factor in colorectal cancer, but has not been evaluated specifically in young patients. The objective of the study was to determine factors associated with poor outcome in young patients with colorectal cancer (≤40 years) and to determine relationships between mucinous histology and oncologic outcomes in this population. This is a retrospective study. Patients from a single-institution tertiary care center were studied. A total of 224 patients with colorectal cancer under 40 years of age diagnosed between 1990 and 2010 were included (mean age, 34.7 years; 51.3% female). 34 patients (15.2%) had mucinous histology. There were no interventions. Oncologic outcomes were analyzed according to the presence of mucinous histology. The mucinous and nonmucin colorectal cancer study populations were statistically similar in age, sex, tumor location, pathological stage, differentiation, and adjuvant chemotherapy use. Five-year disease-free survival was 29.1% versus 71.3% (p < 0.0001) and 5-year overall survival was 54.7% versus 80.3% (p < 0.0001) for mucinous and nonmucinous patients, respectively. Mucinous colorectal cancers recurred earlier at a median time of 36.4 months versus 94.2 months for nonmucin colorectal cancers (p < 0.001). On multivariate analysis, pathological stage (stage II HR, 3.61; 95% CI, 1.37-9.50; stage III HR, 5.27; 95% CI, 2.12-12.33), positive margins (HR, 1.95; 95% CI, 1.12-3.23), angiolymphatic invasion (HR, 2.15; 95% CI, 1.26-3.97), and mucinous histology (HR, 2.36; 95% CI, 1.44-3.96) were independently associated with worse disease-free and overall survival. This is a retrospective study without genetic information. Mucinous histology is a negative prognostic factor in young patients with colorectal cancer. This is associated with early and high recurrence rates, despite use of

  9. High EphA2 protein expression in renal cell carcinoma is associated with a poor disease outcome.

    PubMed

    Xu, Jinsheng; Zhang, Junxia; Cui, Liwen; Zhang, Huiran; Zhang, Shenglei; Bai, Yaling

    2014-08-01

    The receptor tyrosine kinase, ephrin type-A receptor 2 (EphA2), is normally expressed at sites of cell-to-cell contact in adult epithelial tissues, however, recent studies have shown that it is also overexpressed in various types of epithelial carcinomas, with the greatest level of EphA2 expression observed in metastatic lesions. In the present study, the association between the expression of EphA2 and the outcome of RCC patients was assessed. The high expression level of EphA2 was identified by log-rank test for a statistically significant prediction of the RCC outcome. In an overall multivariate analysis, the high expression level of EphA2 was identified as an independent predictor of RCC outcome. The length of survival of the patients with high EphA2 expression was shorter than that of the patients with a low level of expression (relative risk, 2.304; 95% CI, 1.102-4.818; P=0.027). The analysis of the expression levels of EphA2 in tumor tissues may aid in the identification of the patient subgroup that are at a high risk of a poor disease outcome.

  10. Missing Data in Alcohol Clinical Trials with Binary Outcomes

    PubMed Central

    Hallgren, Kevin A.; Witkiewitz, Katie; Kranzler, Henry R.; Falk, Daniel E.; Litten, Raye Z.; O’Malley, Stephanie S.; Anton, Raymond F.

    2017-01-01

    Background Missing data are common in alcohol clinical trials for both continuous and binary endpoints. Approaches to handle missing data have been explored for continuous outcomes, yet no studies have compared missing data approaches for binary outcomes (e.g., abstinence, no heavy drinking days). The present study compares approaches to modeling binary outcomes with missing data in the COMBINE study. Method We included participants in the COMBINE Study who had complete drinking data during treatment and who were assigned to active medication or placebo conditions (N=1146). Using simulation methods, missing data were introduced under common scenarios with varying sample sizes and amounts of missing data. Logistic regression was used to estimate the effect of naltrexone (vs. placebo) in predicting any drinking and any heavy drinking outcomes at the end of treatment using four analytic approaches: complete case analysis (CCA), last observation carried forward (LOCF), the worst-case scenario of missing equals any drinking or heavy drinking (WCS), and multiple imputation (MI). In separate analyses, these approaches were compared when drinking data were manually deleted for those participants who discontinued treatment but continued to provide drinking data. Results WCS produced the greatest amount of bias in treatment effect estimates. MI usually yielded less biased estimates than WCS and CCA in the simulated data, and performed considerably better than LOCF when estimating treatment effects among individuals who discontinued treatment. Conclusions Missing data can introduce bias in treatment effect estimates in alcohol clinical trials. Researchers should utilize modern missing data methods, including MI, and avoid WCS and CCA when analyzing binary alcohol clinical trial outcomes. PMID:27254113

  11. Missing Data in Alcohol Clinical Trials with Binary Outcomes.

    PubMed

    Hallgren, Kevin A; Witkiewitz, Katie; Kranzler, Henry R; Falk, Daniel E; Litten, Raye Z; O'Malley, Stephanie S; Anton, Raymond F

    2016-07-01

    Missing data are common in alcohol clinical trials for both continuous and binary end points. Approaches to handle missing data have been explored for continuous outcomes, yet no studies have compared missing data approaches for binary outcomes (e.g., abstinence, no heavy drinking days). This study compares approaches to modeling binary outcomes with missing data in the COMBINE study. We included participants in the COMBINE study who had complete drinking data during treatment and who were assigned to active medication or placebo conditions (N = 1,146). Using simulation methods, missing data were introduced under common scenarios with varying sample sizes and amounts of missing data. Logistic regression was used to estimate the effect of naltrexone (vs. placebo) in predicting any drinking and any heavy drinking outcomes at the end of treatment using 4 analytic approaches: complete case analysis (CCA), last observation carried forward (LOCF), the worst case scenario (WCS) of missing equals any drinking or heavy drinking, and multiple imputation (MI). In separate analyses, these approaches were compared when drinking data were manually deleted for those participants who discontinued treatment but continued to provide drinking data. WCS produced the greatest amount of bias in treatment effect estimates. MI usually yielded less biased estimates than WCS and CCA in the simulated data and performed considerably better than LOCF when estimating treatment effects among individuals who discontinued treatment. Missing data can introduce bias in treatment effect estimates in alcohol clinical trials. Researchers should utilize modern missing data methods, including MI, and avoid WCS and CCA when analyzing binary alcohol clinical trial outcomes. Copyright © 2016 by the Research Society on Alcoholism.

  12. Lumbar Disc Replacement for Junctional Decompensation After Fusion Surgery: Clinical and Radiological Outcome at an Average Follow-Up of 33 Months

    PubMed Central

    Sliwa, Karen; Weinberg, Ian R.; Sweet, Barry MBE; de Villiers, Malan; Candy, Geoffrey P.

    2007-01-01

    Background Failed fusion surgery remains difficult to treat. Few published data on disc replacement surgery after failed fusion procedures exist. Our objective was to evaluate outcomes of junctional lumbar disc replacement after previous fusion surgery and to correlate outcome with radiological changes to parameters of sagittal balance. Methods Out of a single-center prospective registry of 290 patients with 404 lumbar disc replacements, 27 patients had had a previous lumbar fusion operation on 1 to 4 lumbar segments and had completed a mean follow- up of 33 months (range: 18–56). We correlated the clinical outcome measures (patient satisfaction, 10-point pain score, and Oswestry Disability Index [ODI] score) to parameters of spinal sagittal alignment (sacral tilt, pelvic tilt, pelvic incidence, and lumbar lordosis). Results Postoperative hospital stay averaged 3.3 days (range: 2–8). Previously-employed patients went back to their jobs with a mean of 32 days (range: 21–42) after the procedure. At the latest follow-up, 1 of the patients considered the outcome to be poor, 3 fair, 8 good, and 15 excellent. Twenty-four patients “would undergo the operation again.” Average pain score decreased from 9.1 ± 1.0 (SD) to 3.2 ± 2.1 (P < .01). Average ODI decreased from 50.2 ± 9.9 preoperatively to 21.7 ± 14.2 (P ≤ .01). We found the change in pelvic tilt to be an independent predictor of better clinical outcome by multivariate analysis (P < .05). Conclusions In patients with junctional failure adjacent to a previous posterolateral fusion, disc replacement at the junctional level(s), compared with osteotomy and fusion surgery, offers the advantage of maintaining segmental mobility and correcting the flat-back deformity through a single approach with less operative time and blood loss. Early- to intermediate-term results are promising. The influence of changes in spinal sagittal alignment on clinical outcome needs to be addressed in future research. Clinical

  13. Fear Avoidance and Clinical Outcomes from Mild Traumatic Brain Injury.

    PubMed

    Silverberg, Noah D; Panenka, William; Iverson, Grant L

    2018-04-18

    Characterizing psychological factors that contribute to persistent symptoms after mild traumatic brain injury (MTBI) can inform early intervention. To determine whether fear avoidance, a known risk factor for chronic disability after musculoskeletal injury, is associated with worse clinical outcomes from MTBI, adults were recruited from four outpatient MTBI clinics and assessed at their first clinic visit (M=2.7, SD=1.5 weeks post-injury) and again 4-5 months later. Of 273 patients screened, 102 completed the initial assessment and 87 returned for the outcome assessment. The initial assessment included a battery of questionnaires that measure activity avoidance and associated fears. Endurance, an opposite behavior pattern, was measured with the Behavioral Response to Illness Questionnaire. The multidimensional outcome assessment included measures of post-concussion symptoms (British Columbia Postconcussion Symptom Inventory), functional disability (World Health Organization Disability Assessment Schedule-12 2.0), return to work status, and psychiatric complications (MINI Neuropsychiatric Interview). A single component was retained from principal components analysis of the six avoidance subscales. In generalized linear modeling, the avoidance composite score predicted symptom severity (95% confidence interval [CI] for B= 1.22-6.33) and disability (95% CI for B=2.16-5.48), but not return to work (95% CI for B=-0.68-0.24). The avoidance composite was also associated with an increased risk for depression (OR=1.76, 95% CI=1.02-3.02) and anxiety disorders (OR=1.89, 95% CI=1.16-3.19). Endurance behavior predicted the same outcomes, except for depression. In summary, avoidance and endurance behavior were associated with a range of adverse clinical outcomes from MTBI. These may represent early intervention targets.

  14. Clinical characteristics and pregnancy outcomes of Syrian refugees: a case-control study in a tertiary care hospital in Istanbul, Turkey.

    PubMed

    Erenel, Hakan; Aydogan Mathyk, Begum; Sal, Veysel; Ayhan, Isil; Karatas, Suat; Koc Bebek, Arzu

    2017-01-01

    We aimed to compare the clinical characteristics and pregnancy outcomes in women who are Syrian refugees and Turkish women who are non-refugees at a maternity center in Istanbul, Turkey. A total of 600 singleton pregnancies who delivered at Sisli Hamidiye Etfal Training and Research Hospital were included in the study. Demographic data, obstetrical history, clinical findings, obstetrical and neonatal outcomes were compared between 300 Syrian refugees and 300 control patients. The Syrian refugee patients were significantly younger than Turkish patients. The percentage of adolescents aged 12-19 years were significantly higher in the Syrian patients (14.3 vs. 5.3 %, p < 0,001). 41.3 % of the refugee patients had no antenatal care. However, this ratio was only 7.7 % for the control group (p < 0.001). Preterm birth rates showed no difference between the groups, however, postterm birth rates were significantly higher in the control group. Low Birthweight (<2500 gr), oligohydramnios, stillbirth and fetal anomaly rates were not different between the two groups. In comparison to non-refugee control patients, refugee women in our study had poor antenatal care but no adverse perinatal outcomes were observed. Further larger multicenter studies may provide more convincing data about obstetric outcomes in the Syrian refugee population as well as adolescent pregnancies in this population.

  15. 3'UTR Polymorphism in ACSL1 Gene Correlates with Expression Levels and Poor Clinical Outcome in Colon Cancer Patients.

    PubMed

    Vargas, Teodoro; Moreno-Rubio, Juan; Herranz, Jesús; Cejas, Paloma; Molina, Susana; Mendiola, Marta; Burgos, Emilio; Custodio, Ana B; De Miguel, María; Martín-Hernández, Roberto; Reglero, Guillermo; Feliu, Jaime; Ramírez de Molina, Ana

    2016-01-01

    Strong evidence suggests that lipid metabolism (LM) has an essential role in tumor growth to support special energetic and structural requirements of tumor cells. Recently, overexpression of LM-related genes, apolipoproteins related to metabolic syndrome, and ACSL/SCD network involved in fatty acid activation have been proposed as prognostic markers of colon cancer (CC). Furthermore, activation of this latter lipid network has been recently demonstrated to confer invasive and stem cell properties to tumor cells promoting tumor aggressiveness and patient relapse. With the aim of elucidating whether any genetic variation within these genes could influence basal expression levels and consequent susceptibility to relapse, we genotype, in 284 CC patients, 57 polymorphisms located in the 7 genes of these lipid networks previously associated with worse clinical outcome of CC patients (ABCA1, ACSL1, AGPAT1, APOA2, APOC1, APOC2 and SCD), some of them related to CC aggressiveness. After adjusting with clinical confounding factors and multiple comparisons, an association between genotype and disease-free survival (DFS) was shown for rs8086 in 3'-UTR of ACSL1 gene (HR 3.08; 95% CI 1.69-5.63; adjusted p = 0.046). Furthermore, the risk T/T genotype had significantly higher ACSL1 gene expression levels than patients carrying C/T or C/C genotype (means = 5.34; 3.73; 2.37 respectively; p-value (ANOVA) = 0.019), suggesting a functional role of this variant. Thus, we have identified a "risk genotype" of ACSL1 gene that confers constitutive high levels of the enzyme, which is involved in the activation of fatty acids through conversion to acyl-CoA and has been recently related to increased invasiveness of tumor cells. These results suggest that rs8086 of ACSL1 could be a promising prognostic marker in CC patients, reinforcing the relevance of LM in the progression of CC.

  16. Prevalence, Clinical Profile, and Outcome of Ascitic Fluid Infection in Children With Liver Disease.

    PubMed

    Srivastava, Anshu; Malik, Rohan; Bolia, Rishi; Yachha, Surender K; Poddar, Ujjal

    2017-02-01

    Pediatric literature on spontaneous bacterial peritonitis (SBP) is limited. We evaluated the prevalence, subtypes, clinical profile, and effect on outcome of ascitic fluid infection (AFI) in children with liver disease. Children with liver disease-related ascites and subjected to paracentesis were classified as no-AFI and AFI (SBP, culture-negative neutrocytic ascites [CNNA], and monomicrobial non-neutrocytic bacterascites). Clinical and laboratory parameters, in-hospital mortality, and outcome in follow-up were noted. Two hundred sixty-two children (163 boys; age 84 [1-240] months, chronic liver disease [CLD, n = 173], non-CLD [n = 89]) were enrolled. A total of 28.6% (n = 75) had SBP/CNNA, more common in CLD than non-CLD (55/173 [31.7%] vs 20/89 [22.4%]; P = 0.1). A total of 50.6% SBP/CNNA cases were symptomatic for AFI. Gram-negative bacilli were isolated from 70% SBP cases. Twenty-five percent (18/72) CLD children with AFI had a poor hospital outcome, with INR, Child-Pugh score and gastrointestinal bleeding predicting outcome on multivariate analysis. Patients with CLD with SBP had higher in-hospital mortality (10/20 vs 5/35; P = 0.01) than those with CNNA, but similar Child-Pugh score (12[7-15] vs 11[7-14]; P = 0.1), recurrence of AFI (3/9 vs 6/24; P = 0.6) and mortality in follow-up (22.2% vs 25%; P = 0.1). Patients with CLD with SBP/CNNA had higher mortality over 1 year follow-up than no-AFI (24.2% [8/33] vs 12.2% [7/57]; P = 0.1) but the difference was not significant. A total of 28.6% children with liver disease-related ascites have SBP/CNNA; 50% are symptomatic. Patients with CLD with SBP/CNNA have a mortality of 24% over 1year follow-up. CLD with SBP is similar to CNNA except for higher in-hospital mortality.

  17. Clinical prediction of functional outcome after ischemic stroke: the surprising importance of periventricular white matter disease and race.

    PubMed

    Kissela, Brett; Lindsell, Christopher J; Kleindorfer, Dawn; Alwell, Kathleen; Moomaw, Charles J; Woo, Daniel; Flaherty, Matthew L; Air, Ellen; Broderick, Joseph; Tsevat, Joel

    2009-02-01

    We sought to build models that address questions of interest to patients and families by predicting short- and long-term mortality and functional outcome after ischemic stroke, while allowing for risk restratification as comorbid events accumulate. A cohort of 451 ischemic stroke subjects in 1999 were interviewed during hospitalization, at 3 months, and at approximately 4 years. Medical records from the acute hospitalization were abstracted. All hospitalizations for 3 months poststroke were reviewed to ascertain medical and psychiatric comorbidities, which were categorized for analysis. Multivariable models were derived to predict mortality and functional outcome (modified Rankin Scale) at 3 months and 4 years. Comorbidities were included as modifiers of the 3-month models, and included in 4-year predictions. Poststroke medical and psychiatric comorbidities significantly increased short-term poststroke mortality and morbidity. Severe periventricular white matter disease (PVWMD) was significantly associated with poor functional outcome at 3 months, independent of other factors, such as diabetes and age; inclusion of this imaging variable eliminated other traditional risk factors often found in stroke outcomes models. Outcome at 3 months was a significant predictor of long-term mortality and functional outcome. Black race was a predictor of 4-year mortality. We propose that predictive models for stroke outcome, as well as analysis of clinical trials, should include adjustment for comorbid conditions. The effects of PVWMD on short-term functional outcomes and black race on long-term mortality are findings that require confirmation.

  18. Influence of clinical outcome and outcome period definitions on estimates of absolute clinical and economic benefits of influenza vaccination in community dwelling elderly persons.

    PubMed

    Nichol, K L; Nordin, J; Mullooly, J

    2006-03-06

    Studies assessing the clinical and economic benefits of vaccination in the elderly have used different clinical outcomes (e.g. hospitalizations for pneumonia or influenza versus hospitalizations for respiratory and cardiovascular causes) and different outcome periods (e.g. peak versus total influenza season) on which to base estimates of clinical effectiveness and cost effectiveness. We explored the implications of these varying approaches by comparing two health economic analysis models of influenza vaccination of community-dwelling elderly persons. We developed computerized models using clinical data from 3 large US HMOs for the 1998-1999 and 1999-2000 influenza seasons. The primary health economic model used a broad definition of clinical events and outcome period and included hospitalizations for all respiratory and cardiovascular events that occurred during the entire influenza season. The alternative model used more restrictive definitions and included pneumonia or influenza hospitalizations occurring during the peak influenza season. The results of Monte Carlo simulation showed that, with the more inclusive primary model, influenza vaccination resulted in net medical care cost savings due to fewer respiratory or cardiovascular hospitalizations of Dollars 71/person vaccinated (5th-95th percentile Dollars 32-118) and net savings of Dollars 809/year of life saved (5th-95th percentile Dollars 331-1450). In contrast, the alternate model found costs of Dollars 3.50/person vaccinated (5th-95th percentile Dollars -11 to 5) and net costs of Dollars 91/year of life saved (5th-95th percentile Dollars -309 to 126). Our findings confirm that influenza vaccination of the elderly is most likely cost saving and supports policies and programs that advocate routine immunization of all persons 65 and older. They also highlight how different outcome definitions can influence the results of health economic analyses.

  19. Differences in clinical ocular outcomes between exogenous and endogenous endophthalmitis caused by Sporothrix: a systematic review of published literature.

    PubMed

    Ramírez Soto, Max Carlos

    2017-09-28

    Sporotrichosis is an implantation mycosis caused by Sporothrix species prevalent worldwide, which occasionally can also result in intraocular infection presenting as an exogenous or endogenous infection (disseminated sporotrichosis). Knowledge in its clinical recognition and management is limited. To systematically review and analyse data from published literature with a view to comparing clinical outcomes between exogenous and endogenous endophthalmitis caused by Sporothrix . Case reports of intraocular sporotrichosis, published from 1960 to 2016, were retrieved from MEDLINE, Embase, Cochrane, LILACS and SciELO databases. The entire data set was divided into two patient groups: (1) exogenous endophthalmitis and (2) endogenous endophthalmitis. Primary outcomes were differences in ocular findings and clinical ocular outcomes between the two groups. From 16 publications retrieved, a total of 8 eyes of 8 patients with exogenous endophthalmitis and 13 eyes of 10 patients with endogenous endophthalmitis were identified. Compared with exogenous endophthalmitis, endogenous endophthalmitis was more common in patients infected with HIV (p=0.001) and those from hyperendemic areas (p=0.036). Anterior uveitis (p=0.015) and posterior uveitis (p=0.04) were more common in the exogenous and endogenous endophthalmitis groups, respectively. The majority of patients with endogenous endophthalmitis had partial or full clinical resolution of ocular lesions with systemic amphotericin B alone or in combination with an oral antifungal, whereas patients with exogenous endophthalmitis had poor outcomes with irreversible vision loss, enucleation and evisceration. Anterior uveitis is more common in exogenous endophthalmitis with worse overall outcomes and complications, compared with endogenous endophthalmitis where posterior uveitis is the most common clinical manifestation, especially in patients infected with HIV and those from hyperendemic areas. Sporothrix infection should be included in

  20. Type D Personality Predicts Poor Medication Adherence in Patients with Heart Failure in the USA

    PubMed Central

    Wu, Jia-Rong; Moser, Debra K.

    2015-01-01

    Background Type D (distressed) personality and medication nonadherence have been associated with poor health outcomes. Type D personality is associated with poor medication adherence in patients with coronary artery disease. However, the relationship between type D personality and medication adherence in patients with heart failure (HF) remains unknown. Purpose Therefore, the goal of this study was to examine the association between type D personality and medication adherence in patients with HF. Method This was a sub-analysis of baseline data from a randomized controlled trial with 84 patients with HF in the USA. Demographic, clinical, and psychological data were collected at baseline by interview, questionnaires, and medical record review. Type D personality was assessed using the Type D Personality Scale (DS14). Medication adherence was measured using both objective (Medication Event Monitoring System, MEMS) and self-reported (Morisky Medication Adherence Scale, MMAS-4) measures. Patients started medication adherence monitoring with the MEMS bottle at baseline and is used continuously for a month. Multiple regressions were used to explore the relationships between type D personality and medication adherence while adjusting for demographic, clinical, and psychological factors. Results Patients with type D personality were more likely to have poor medication adherence. Type D personality was associated with medication adherence before and after adjusting for covariates when it was analyzed as a categorical variable. However, type D personality was not associated with medication adherence when analyzed as a dimensional construct. Negative affectivity, a component of type D personality, was associated with medication adherence. Conclusion As a dimensional construct, type D personality may not reflect the components of the personality associated with poor outcomes. Negative affectivity was associated with medication adherence in patients with HF. Interventions aiming

  1. Keyhole Approach Combined With External Ventricular Drainage for Ruptured, Poor-Grade, Anterior Circulation Cerebral Aneurysms

    PubMed Central

    Zheng, Shu-Fa; Yao, Pei-Sen; Yu, Liang-Hong; Kang, De-Zhi

    2015-01-01

    Abstract Poor-grade ruptured anterior circulation cerebral aneurysms are frequently associated with severe vasospasm and high morbidity rates despite recent remarkable advances in endovascular coiling. Here, we explored the feasibility of keyhole approach combined with external ventricular drainage for ruptured, poor-grade, anterior circulation cerebral aneurysms. We retrospectively assessed the records of 103 patients with ruptured, Hunt and Hess grade IV or V, anterior circulation cerebral aneurysms. The patients were divided into 2 groups (conservative group and surgical group). In surgical group, patients were divided into 2 subgroups according to surgical time (within 24 hours and at 24–48 hours). Clinical outcome was assessed at the 6-month follow-up and categorized according to modified Rankin Scale (mRS) score. Twenty percent of patients (9/44) in conservative group obtained good outcome, while 54% (32/54) in surgical group (P < 0.05). Mortality was 73% in conservative group and 40% in surgical group, respectively. In surgical group, age, Hunt and Hess grade (IV or V), and timing of intervention (<24 hours or later) influenced the clinical outcome of the patients (P < 0.05), while sex, Fisher grade, hydrocephalus, the location of aneurysms, and cerebral vasospasm (CVS) not (P > 0.05). Furthermore, 65% of patients (22/34) operated within 24 hours after onset of hemorrhage had a good outcome compared with 20% of patients (5/25) operated at 24 to 48 hours in surgical group (P < 0.05). The results indicate that keyhole approach combined with external ventricular drainage is a safe and reliable treatment for ruptured, poor-grade, anterior circulation cerebral aneurysms in early stage, which will reduce mortality. PMID:26705215

  2. Neurologic examination at 24–48 hours predicts functional outcomes in basilar artery occlusion stroke

    PubMed Central

    Rangaraju, Srikant; Jovin, Tudor G.; Frankel, Michael; Schonewille, Wouter J.; Algra, Ale; Kappelle, L. Jaap; Nogueira, Raul G.

    2016-01-01

    Background and Purpose Accurate long-term outcome prognostication in basilar artery occlusion (BAO) strokes may guide clinical management in the subacute stage. We determine the prognostic value of the follow-up neurologic examination using the NIH stroke scale (NIHSS) and identify 24–48 hours NIHSS risk categories in BAO patients. Methods Participants of an observational registry of radiologically-confirmed acute BAO (BASICS) with prospectively collected 24–48 hours NIHSS and 1-month modified Rankin Scale (mRS) scores were included. Uni- and multivariable modeling were performed to identify independent predictors of poor outcome. Predictive powers of baseline and 24–48 hour NIHSS for poor outcome (mRS 4–6) and 1-month mortality were determined by Receiver Operating Characteristic analyses. Classification and regression tree (CART) analysis was performed to identify risk groups. Results 376 of 619 BASICS participants were included of whom 65.4% had poor outcome. In multivariable analyses, 24–48 hours NIHSS (OR=1.28 [1.21–1.35]), history of minor stroke (OR=2.64 [1.04–6.74], time to treatment >6 hours (OR=3.07 [1.35–6.99]) and age (OR 1.02 [0.99–1.04] were retained in the final model as predictors of poor outcome. Prognostic power of 24–48 hours NIHSS was higher than baseline NIHSS for 1-month poor outcome (AUC 0.92 vs. 0.75) and mortality (AUC 0.85 vs. 0.72). CART analysis identified five 24–48 hour NIHSS risk categories with poor outcome rates of 9.4% (NIHSS 0–4), 36% (NIHSS 5–11), 84.3% (NIHSS 12–22), 96.1% (NIHSS 23–27) and 100% (NIHSS≥28). Conclusion 24–48 hour NIHSS accurately predicts 1-month poor outcome and mortality and represents a clinically valuable prognostic tool for the care of BAO patients. PMID:27586683

  3. LDHA in neuroblastoma is associated with poor outcome and its depletion decreases neuroblastoma growth independent of aerobic glycolysis.

    PubMed

    Dorneburg, Carmen; Fischer, Matthias; Barth, Thomas F E; Mueller-Klieser, Wolfgang; Hero, Barbara; Gecht, Judith; Carter, Daniel R; De Preter, Katleen; Mayer, Benjamin; Christner, Lisa; Speleman, Frank; Marshall, Glenn M; Debatin, Klaus-Michael; Beltinger, Christian

    2018-06-20

    To investigate whether lactate dehydrogenase A (LDHA), an important component of the LDH tetramer crucial for aerobic glycolysis, is associated with patient outcome and constitutes a therapeutic target in neuroblastoma (NB). Expression of LDHA mRNA and protein was determined in 709 and 110 NB patient samples, respectively, and correlated to survival and risk factors. LDHA and LDHB were depleted in human NB cell lines by CRISPR/Cas9 and shRNA, respectively, and aerobic glycolysis, clonogenicity and tumorigenicity were determined. Expression of LDHA in relation to MYCN was measured in NB cell lines and in the TH-MYCN NB mouse model. Expression of LDHA, both on the mRNA and the protein level, was significantly and independently associated with decreased patient survival. Predominant cytoplasmic localization of LDHA protein was associated with poor outcome. Amplification and expression of MYCN did not correlate with expression of LDHA in NB cell lines or TH-MYCN mice, respectively. Knockout of LDHA inhibited clonogenicity, tumorigenicity and tumor growth without abolishing LDH activity or significantly decreasing aerobic glycolysis. Concomitant depletion of LDHA and the isoform LDHB ablated clonogenicity while not abrogating LDH activity or decreasing aerobic glycolysis. The isoform LDHC was not expressed. High expression of LDHA is independently associated with poor outcome of NB and NB cells can be inhibited by depletion of LDHA or LDHB. This inhibition appears to be unrelated to LDH activity and aerobic glycolysis. Thus, investigations of inhibitory mechanisms beyond attenuation of aerobic glycolysis are warranted, both in NB and normal cells. Copyright ©2018, American Association for Cancer Research.

  4. Fibrocartilaginous embolic myelopathy: demographics, clinical presentation, and functional outcomes.

    PubMed

    Moore, Brittany J; Batterson, Anna M; Luetmer, Marianne T; Reeves, Ronald K

    2018-05-25

    Retrospective cohort study. To describe the demographics, clinical presentation, and functional outcomes of fibrocartilaginous embolic myelopathy (FCEM). Academic inpatient rehabilitation unit in the midwestern United States. We retrospectively searched our database to identify patients admitted between January 1, 1995 and March 31, 2016, with a high probability of FCEM. Demographic, clinical, and functional outcome measures, including Functional Independence Measure (FIM) information was obtained by chart review. We identified 31 patients with findings suggestive of FCEM (52% male), which was 2% of the nontraumatic spinal cord injury population admitted to inpatient rehabilitation. The age distribution was bimodal, with peaks in the second and sixth-to-seventh decades. The most common clinical presentation was acute pain and rapid progression of neurologic deficits consistent with a vascular myelopathy. Only three patients (10%) had FCEM documented as a diagnostic possibility. Most patients had paraplegia and neurologically incomplete injuries and were discharged to home. Nearly half of the patients required no assistive device for bladder management at discharge, but most were discharged with medications for bowel management. Median FIM walking locomotion score for all patients was 5, but most patients were discharged using a wheelchair for primary mobility. Median motor FIM subscale score was 36 at admission and 69 at discharge, with a median motor efficiency of 1.41. FCEM may be underdiagnosed and should be considered in those with the appropriate clinical presentation, because their functional outcomes may be more favorable than those with other causes of spinal cord infarction.

  5. Clinical Manifestations and Outcomes of West Nile Virus Infection

    PubMed Central

    Sejvar, James J.

    2014-01-01

    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. PMID:24509812

  6. Redefining Perineural Invasion: Integration of Biology With Clinical Outcome.

    PubMed

    Schmitd, Ligia B; Beesley, Lauren J; Russo, Nickole; Bellile, Emily L; Inglehart, Ronald C; Liu, Min; Romanowicz, Genevieve; Wolf, Gregory T; Taylor, Jeremy M G; D'Silva, Nisha J

    2018-05-22

    A diagnosis of perineural invasion (PNI), defined as cancer within or surrounding at least 33% of the nerve, leads to selection of aggressive treatment in squamous cell carcinoma (SCC). Recent mechanistic studies show that cancer and nerves interact prior to physical contact. The purpose of this study was to explore cancer-nerve interactions relative to clinical outcome. Biopsy specimens from 71 patients with oral cavity SCC were stained with hematoxylin and eosin and immunohistochemical (IHC; cytokeratin, S100, GAP43, Tuj1) stains. Using current criteria, PNI detection was increased with IHC. Overall survival (OS) tended to be poor for patients with PNI (P = .098). OS was significantly lower for patients with minimum tumor-nerve distance smaller than 5 μm (P = .011). The estimated relative death rate decreased as the nerve-tumor distance increased; there was a gradual drop off in death rate from distance equal to zero that stabilized around 500 μm. In PNI-negative patients, nerve diameter was significantly related to OS (HR 2.88, 95%CI[1.11,7.49]). Among PNI-negative nerves, larger nerve-tumor distance and smaller nerve diameter were significantly related to better OS, even when adjusting for T-stage and age (HR 0.82, 95% CI[0.72,0.92]; HR 1.27, 95% CI[1.00,1.62], respectively). GAP43, a marker for neuronal outgrowth, stained less than Tuj1 in nerves at greater distances from tumor (OR 0.76, 95% CI[0.73,0.79]); more GAP43 staining was associated with PNI. Findings from a small group of patients suggest that nerve parameters other than presence of PNI can influence outcome and that current criteria of PNI need to be re-evaluated to integrate recent biological discoveries. Copyright © 2018 The Authors. Published by Elsevier Inc. All rights reserved.

  7. Poor long-term outcomes for cryptococcal meningitis in rural South Africa.

    PubMed

    Lessells, Richard J; Mutevedzi, Portia C; Heller, Tom; Newell, Marie-Louise

    2011-04-01

    To explore linkage to and retention in HIV care after an episode of cryptococcal meningitis (CM) in rural South Africa. Design. A retrospective case series of adult individuals (> or = 16 years old) with laboratory-confirmed CM from January - December 2007 at Hlabisa Hospital--a district hospital in northern KwaZulu-Natal. Inpatient mortality and associated risk factors were analysed. The proportion alive and on antiretroviral therapy (ART) at 2 years was determined by linkage to the HIV treatment programme. One hundred and four individuals were identified with laboratory diagnosis of CM; 74/104 (71.2%) with complete records were included in the analysis. Inpatient mortality was high (40.5%) and was significantly associated with reduced conscious level (aHR 3.09, 95% CI 1.30 - 7.33) and absence of headache (aHR 0.33 for headache, 95% CI 0.13 - 0.87). Only 8 individuals (10.8% of all study subjects) were alive and receiving ART 2 years after the CM episode. Long-term outcomes of CM are poor in routine practice. Interventions to strengthen linkage to HIV treatment and care and continuation of secondary fluconazole prophylaxis are critical.

  8. Modeling the economic outcomes of immuno-oncology drugs: alternative model frameworks to capture clinical outcomes

    PubMed Central

    Gibson, EJ; Begum, N; Koblbauer, I; Dranitsaris, G; Liew, D; McEwan, P; Tahami Monfared, AA; Yuan, Y; Juarez-Garcia, A; Tyas, D; Lees, M

    2018-01-01

    Background Economic models in oncology are commonly based on the three-state partitioned survival model (PSM) distinguishing between progression-free and progressive states. However, the heterogeneity of responses observed in immuno-oncology (I-O) suggests that new approaches may be appropriate to reflect disease dynamics meaningfully. Materials and methods This study explored the impact of incorporating immune-specific health states into economic models of I-O therapy. Two variants of the PSM and a Markov model were populated with data from one clinical trial in metastatic melanoma patients. Short-term modeled outcomes were benchmarked to the clinical trial data and a lifetime model horizon provided estimates of life years and quality adjusted life years (QALYs). Results The PSM-based models produced short-term outcomes closely matching the trial outcomes. Adding health states generated increased QALYs while providing a more granular representation of outcomes for decision making. The Markov model gave the greatest level of detail on outcomes but gave short-term results which diverged from those of the trial (overstating year 1 progression-free survival by around 60%). Conclusion Increased sophistication in the representation of disease dynamics in economic models is desirable when attempting to model treatment response in I-O. However, the assumptions underlying different model structures and the availability of data for health state mapping may be important limiting factors. PMID:29563820

  9. Modeling the economic outcomes of immuno-oncology drugs: alternative model frameworks to capture clinical outcomes.

    PubMed

    Gibson, E J; Begum, N; Koblbauer, I; Dranitsaris, G; Liew, D; McEwan, P; Tahami Monfared, A A; Yuan, Y; Juarez-Garcia, A; Tyas, D; Lees, M

    2018-01-01

    Economic models in oncology are commonly based on the three-state partitioned survival model (PSM) distinguishing between progression-free and progressive states. However, the heterogeneity of responses observed in immuno-oncology (I-O) suggests that new approaches may be appropriate to reflect disease dynamics meaningfully. This study explored the impact of incorporating immune-specific health states into economic models of I-O therapy. Two variants of the PSM and a Markov model were populated with data from one clinical trial in metastatic melanoma patients. Short-term modeled outcomes were benchmarked to the clinical trial data and a lifetime model horizon provided estimates of life years and quality adjusted life years (QALYs). The PSM-based models produced short-term outcomes closely matching the trial outcomes. Adding health states generated increased QALYs while providing a more granular representation of outcomes for decision making. The Markov model gave the greatest level of detail on outcomes but gave short-term results which diverged from those of the trial (overstating year 1 progression-free survival by around 60%). Increased sophistication in the representation of disease dynamics in economic models is desirable when attempting to model treatment response in I-O. However, the assumptions underlying different model structures and the availability of data for health state mapping may be important limiting factors.

  10. Study Comparing Vein Integrity and Clinical Outcomes in Open Vein Harvesting and 2 Types of Endoscopic Vein Harvesting for Coronary Artery Bypass Grafting: The VICO Randomized Clinical Trial (Vein Integrity and Clinical Outcomes)

    PubMed Central

    Krishnamoorthy, Bhuvaneswari; Critchley, William R.; Thompson, Alexander J.; Payne, Katherine; Morris, Julie; Venkateswaran, Rajamiyer V.; Caress, Ann L.

    2018-01-01

    Background Current consensus statements maintain that endoscopic vein harvesting (EVH) should be standard care in coronary artery bypass graft surgery, but vein quality and clinical outcomes have been questioned. The VICO trial (Vein Integrity and Clinical Outcomes) was designed to assess the impact of different vein harvesting methods on vessel damage and whether this contributes to clinical outcomes after coronary artery bypass grafting. Methods In this single-center, randomized clinical trial, patients undergoing coronary artery bypass grafting with an internal mammary artery and with 1 to 4 vein grafts were recruited. All veins were harvested by a single experienced practitioner. We randomly allocated 300 patients into closed tunnel CO2 EVH (n=100), open tunnel CO2 EVH (n=100), and traditional open vein harvesting (n=100) groups. The primary end point was endothelial integrity and muscular damage of the harvested vein. Secondary end points included clinical outcomes (major adverse cardiac events), use of healthcare resources, and impact on health status (quality-adjusted life-years). Results The open vein harvesting group demonstrated marginally better endothelial integrity in random samples (85% versus 88% versus 93% for closed tunnel EVH, open tunnel EVH, and open vein harvesting; P<0.001). Closed tunnel EVH displayed the lowest longitudinal hypertrophy (1% versus 13.5% versus 3%; P=0.001). However, no differences in endothelial stretching were observed between groups (37% versus 37% versus 31%; P=0.62). Secondary clinical outcomes demonstrated no significant differences in composite major adverse cardiac event scores at each time point up to 48 months. The quality-adjusted life-year gain per patient was 0.11 (P<0.001) for closed tunnel EVH and 0.07 (P=0.003) for open tunnel EVH compared with open vein harvesting. The likelihood of being cost-effective, at a predefined threshold of £20 000 per quality-adjusted life-year gained, was 75% for closed tunnel EVH

  11. User-centered design in clinical handover: exploring post-implementation outcomes for clinicians.

    PubMed

    Wong, Ming Chao; Cummings, Elizabeth; Turner, Paul

    2013-01-01

    This paper examines the outcomes for clinicians from their involvement in the development of an electronic clinical hand-over tool developed using principles of user-centered design. Conventional e-health post-implementation evaluations tend to emphasize technology-related (mostly positive) outcomes. More recently, unintended (mostly negative) consequences arising from the implementation of e-health technologies have also been reported. There remains limited focus on the post-implementation outcomes for users, particularly those directly involved in e-health design processes. This paper presents detailed analysis and insights into the outcomes experienced post-implementation by a cohort of junior clinicians involved in developing an electronic clinical handover tool in Tasmania, Australia. The qualitative methods used included observations, semi-structured interviews and analysis of clinical handover notes. Significantly, a number of unanticipated flow-on effects were identified that mitigated some of the challenges arising during the design and implementation of the tool. The paper concludes by highlighting the importance of identifying post-implementation user outcomes beyond conventional system adoption and use and also points to the need for more comprehensive evaluative frameworks to encapsulate these broader socio-technical user outcomes.

  12. Effect of diabetes on tuberculosis presentation and outcomes in Kiribati.

    PubMed

    Cavanaugh, J; Viney, K; Kienene, T; Harley, D; Kelly, P M; Sleigh, A; O'Connor, J; Mase, S

    2015-05-01

    To determine the association between diabetes and the clinical features and treatment outcomes of TB in Kiribati. We enrolled consecutive patients with TB who presented from August 2010 to February 2012 and compared clinical features and TB treatment outcomes for patients with and without diabetes, as measured by haemoglobin A1c assay. Poor outcome was defined as death, default or treatment failure, and good outcome as treatment success or cure. Two hundred and seventy-five eligible persons with TB disease were enrolled; 101 (37%) had diabetes. TB patients with diabetes were more likely to have acid-fast bacilli (AFB) seen on sputum smear microscopy (RR: 1.3; 95% CI: 1.03-1.62). The risk of poor outcome did not differ between patients with or without diabetes (RR: 1.1; 95% CI: 0.5-2.7). TB patients with diabetes are more likely than those without to have sputum with AFB on microscopy. This could increase transmission in the community. Early detection of TB by screening patients with diabetes, and the converse, could be important public health interventions where diabetes and TB are prevalent. © 2015 John Wiley & Sons Ltd.

  13. Validation of birth outcomes from the Society for Assisted Reproductive Technology Clinic Outcome Reporting System (SART CORS): population-based analysis from the Massachusetts Outcome Study of Assisted Reproductive Technology (MOSART).

    PubMed

    Stern, Judy E; Gopal, Daksha; Liberman, Rebecca F; Anderka, Marlene; Kotelchuck, Milton; Luke, Barbara

    2016-09-01

    To assess the validity of outcome data reported to the Society for Assisted Reproductive Technology Clinic Outcome Reporting System (SART CORS) compared with data from vital records and the birth defects registry in Massachusetts. Longitudinal cohort. Not applicable. A total of 342,035 live births and fetal deaths from Massachusetts mothers giving birth in the state from July 1, 2004, to December 31, 2008; 9,092 births and fetal deaths were from mothers who had conceived with the use of assisted reproductive technology (ART) and whose cycle data had been reported to the SART CORS. Not applicable. Percentage agreement between maternal race and ethnicity, delivery outcome (live birth or fetal death), plurality (singleton, twin, or triplet+), delivery date, and singleton birth weight reported in the SART CORS versus vital records; sensitivity and specificity for birth defects among singletons as reported in the SART CORS versus the Massachusetts Birth Defects Monitoring Program (BDMP). There was >95% agreement between the SART CORS and vital records for fields of maternal race/ethnicity, live birth/fetal death, and plurality; birth outcome date was within 1 day with 94.9% agreement and birth weight was within 100 g with 89.6% agreement. In contrast, sensitivity for report of any birth defect was 38.6%, with a range of 18.4%-50.0%, for specific birth defect categories. Although most SART CORS outcome fields are accurately reported, birth defect variables showed poor sensitivity compared with the gold standard data from the BDMP. We suggest that reporting of birth defects be discontinued. Copyright © 2016 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved.

  14. Reporting of harms outcomes: a comparison of journal publications with unpublished clinical study reports of orlistat trials.

    PubMed

    Hodkinson, Alex; Gamble, Carrol; Smith, Catrin Tudur

    2016-04-22

    The quality of harms reporting in journal publications is often poor, which can impede the risk-benefit interpretation of a clinical trial. Clinical study reports can provide more reliable, complete, and informative data on harms compared to the corresponding journal publication. This case study compares the quality and quantity of harms data reported in journal publications and clinical study reports of orlistat trials. Publications related to clinical trials of orlistat were identified through comprehensive literature searches. A request was made to Roche (Genentech; South San Francisco, CA, USA) for clinical study reports related to the orlistat trials identified in our search. We compared adverse events, serious adverse events, and the reporting of 15 harms criteria in both document types and compared meta-analytic results using data from the clinical study reports against the journal publications. Five journal publications with matching clinical study reports were available for five independent clinical trials. Journal publications did not always report the complete list of identified adverse events and serious adverse events. We found some differences in the magnitude of the pooled risk difference between both document types with a statistically significant risk difference for three adverse events and two serious adverse events using data reported in the clinical study reports; these events were of mild intensity and unrelated to the orlistat. The CONSORT harms reporting criteria were often satisfied in the methods section of the clinical study reports (70-90 % of the methods section criteria satisfied in the clinical study reports compared to 10-50 % in the journal publications), but both document types satisfied 80-100 % of the results section criteria, albeit with greater detail being provided in the clinical study reports. In this case study, journal publications provided insufficient information on harms outcomes of clinical trials and did not specify

  15. Associations between poor sleep quality and psychosocial stress with obesity in reproductive-age women of lower socioeconomic status.

    PubMed

    Tom, Sarah E; Berenson, Abbey B

    2013-01-01

    Prior studies have not examined the role of psychosocial stress in the relationship between poor sleep quality and obesity among women of lower socioeconomic status (SES). We tested the following hypotheses in a sample of reproductive-age women of lower SES: 1) Poor sleep quality is related to increased risk of obesity, and 2) psychosocial stress confounds this association between poor sleep quality and obesity. A total of 927 women age 16 to 40 years attending public health clinics in Southeastern Texas provided information on the Pittsburgh Sleep Quality Index and sociodemographic and health characteristics, including the Perceived Stress Scale. Height, weight, and waist circumference (WC) were measured in clinic. A series of models examined the associations between sleep disturbance, perceived stress, and weight outcomes, accounting for potential confounding factors. Nearly 30% of women were overweight, and 35% were obese. Half of women had a WC of greater than 35 inches. Most women had poor sleep quality and high levels of stress. Sleep quality and perceived stress were not related to body mass index category or WC in models that adjusted for age and race/ethnicity. Adjusting for potential confounding factors did not alter results. Perceived stress did not modify the association between sleep quality and weight outcomes. Poor sleep quality and psychosocial stress were not related to weight in reproductive-aged women of lower SES. However, poor sleep quality, high stress, overweight, and obesity were common in this group. Copyright © 2013 Jacobs Institute of Women's Health. Published by Elsevier Inc. All rights reserved.

  16. Nutritional status and hyperglycemia in the peritransplant period: a review of associations with parenteral nutrition and clinical outcomes.

    PubMed

    Verdi Schumacher, Marina; Moreira Faulhaber, Gustavo Adolpho

    Hematopoietic stem cell transplantation is an established treatment option for various hematological diseases. This therapy involves complex procedures and is associated with several systemic complications. Due to the toxic effects of the conditioning regimen used in allogeneic transplantations, patients frequently suffer from severe gastrointestinal complications and are unable to feed themselves properly. This complex clinical scenario often requires specialized nutritional support, and despite the increasing number of studies available, many questions remain regarding the best way to feed these patients. Parenteral nutrition has been traditionally indicated when the effects on gastrointestinal mucosa are significant; however, the true benefits of this type of nutrition in reducing clinical complications have been questioned. Hyperglycemia is a common consequence of parenteral nutrition that seems to be correlated to poor transplantation outcomes and a higher risk of infections. Additionally, nutrition-related pre-transplantation risk factors are being studied, such as impaired nutritional status, poorly controlled diabetes mellitus and obesity. This review aims to discuss some of these recent issues. A real case of allogeneic transplant was used to illustrate the scenario and to highlight the most important topics that motivated this literature review. Copyright © 2017 Associação Brasileira de Hematologia, Hemoterapia e Terapia Celular. Published by Elsevier Editora Ltda. All rights reserved.

  17. Prospective study of natural history of deep vein thrombosis: early predictors of poor late outcomes.

    PubMed

    van Rij, André M; Hill, Gerry; Krysa, Jo; Dutton, Samantha; Dickson, Riordon; Christie, Ross; Smillie, Judi; Jiang, Ping; Solomon, Clive

    2013-10-01

    A proportion of patients with deep vein thrombosis (DVT) will develop postthrombotic syndrome (PTS). Currently, the only clearly identified risk factors for developing PTS are recurrent ipsilateral DVT and extensive proximal disease. The aim of the study was to assess the natural history of DVT and identify early predictors of poor clinical outcome at 5 years. Patients with suspected acute DVT in the lower limb were assessed prospectively. All patients with a confirmed DVT were asked to participate in this study. Within 7-10 days after diagnosis of DVT, patients underwent a further review, involving clinical, ultrasound, and air plethysmography assessment of both lower limbs. Patients were reassessed at regular intervals for 5 years. One hundred twenty-two limbs in 114 patients were included in this study. Thrombus regression occurred in two phases, with a rapid regression between 10 days and 3 months, and a more gradual regression thereafter. Reflux developed as thrombus regression occurred. Segmental reflux progressed to axial deep reflux and continued to deteriorate in a significant proportion of patients with iliofemoral-popliteal-calf DVT throughout the 5-year study period. Similarly, venous filling index became progressively more abnormal, in this group, over the course of the study. Four risk factors for PTS were identified as best predictors: extensive clot load on presentation; <50% clot regression at 6 months; venous filling index >2.5 mL/sec; and abnormal outflow rate (<0.6). Patients with three or more of these risk factors had a significant risk of developing PTS with sensitivity 100%, specificity 83%, and positive predictive value 67%. Patients scoring 2 or less did not have PTS at 5 years with a negative predictive value of 100%. This is the first study to show that venous assessment at 6 months post-DVT can predict PTS at 5 years. Those who will not develop PTS can be reassured of this at 6 months. Copyright © 2013 Elsevier Inc. All rights reserved.

  18. Clinical significance of skin rash in dengue fever: A focus on discomfort, complications, and disease outcome.

    PubMed

    Huang, Hsin-Wei; Tseng, Han-Chi; Lee, Chih-Hung; Chuang, Hung-Yi; Lin, Shang-Hung

    2016-07-01

    To assess whether the cutaneous features in patients with dengue fever are associated with abnormal blood biochemistry, complications, and poor disease outcome. Forty five patients with dengue fever were identified at a medical center in Kaohsiung, Taiwan, from September to November 2014. All cases were exclusively caused by type 1 dengue virus. Patients were classified into two groups, based on the presence or absence of skin rash, and their rash was subclassified into maculopapular, morbilliform, and petechial types. Clinical symptoms, laboratory data, disease outcome, and complications were compared between the two groups. Thirty two patients with dengue fever developed skin rash (SP group, n = 32) while the rest of 13 did not (SN group, n = 13). The patient numbers in the maculopapular, morbilliform, and petechial group were 4, 21, and 7, respectively. The SP group was younger (P = 0.001), experienced more pruritus (P = 0.008) and more swollen palms/soles (P = 0.015) than the SN group. However, the SN group had greater genital mucosa involvement (P = 0.008), higher platelet transfusion rate (P = 0.003), and lower hemoglobin and hematocrit levels (P = 0.030) than the SP group. Patients with morbilliform lesions had a higher incidence of palm/sole swelling, less genital mucosal involvement, and a lower platelet transfusion rate than did patients with maculopapular or petechial lesions. Cutaneous manifestations provide an important clue to dengue fever. In patients with dengue fever, those with skin rash tend to have itching and swelling of the palms/soles, however, those without skin rash tend to have more complications and poor disease outcomes. Copyright © 2016 Hainan Medical College. Production and hosting by Elsevier B.V. All rights reserved.

  19. Comparison of microdose flare-up and antagonist multiple-dose protocols for poor-responder patients: a randomized study.

    PubMed

    Demirol, Aygul; Gurgan, Timur

    2009-08-01

    To compare the efficacy of the microdose flare-up and multiple-dose antagonist protocols for poor-responder patients in intracytoplasmic sperm injection-ET cycles. A randomized, prospective study. Center for assisted reproductive technology in Turkey. Ninety patients with poor ovarian response in a minimum of two previous IVF cycles. All women were prospectively randomized into two groups by computer-assisted randomization. The patients in group 1 were stimulated according to the microdose flare-up protocol (n = 45), while the patients in group 2 were stimulated according to antagonist multiple-dose protocol (n = 45). The mean number of mature oocytes retrieved was the primary outcome measure, and fertilization rate, implantation rate per embryo, and clinical pregnancy rates were secondary outcome measures. The mean age of the women, the mean duration of infertility, basal FSH level, and the number of previous IVF cycles were similar in both groups. The total gonadotropin dose used was significantly higher in group 2, while the number of oocytes retrieved was significantly greater in group 1. Although the fertilization and clinical pregnancy rates were nonsignificantly higher in group 1 compared with group 2, the implantation rate was significantly higher in the microdose flare-up group than in the multiple-dose antagonist group (22% vs. 11%). The microdose flare-up protocol seems to have a better outcome in poor-responder patients, with a significantly higher mean number of mature oocytes retrieved and higher implantation rate.

  20. Comparison of clinical outcomes of incidental and non- incidental gallbladder cancers: a single-center cross- sectional study.

    PubMed

    Cha, Byung Hyo; Bae, Jong-Myun

    2014-01-01

    Gallbladder cancer (GBC) is a rare malignancy characterized by high invasiveness and poor survival. In a nation-wide cancer survey, the age-standardized incidence rate of GBC was the highest in Jeju Island compared to 15 other provinces in Korea. The purpose of this study was to compare the clinical outcomes of GBC according to the nature of diagnosis, that is, incidental versus non-incidental. Consecutive patients who were newly diagnosed with GBC at the Digestive Disease Center and Department of Internal Medicine, Cheju Halla General Hospital, between November 2008 and November 2011, were enrolled and divided into 2 groups: incidental gallbladder cancer (IGBC) and non-incidental gallbladder cancer (NIGBC). Clinical outcomes were retrospectively compared between the two groups. Seventy-nine patients were enrolled and analyzed in our study. Thirty-three (41.8%) and 46 (58.2%) were identified as IGBC and NIGBC, respectively. The proportions of patients with gallstone disease, gallbladder polyp, and cholecystectomy were significantly different between the two groups. Additionally, the median survival rate was significantly higher for patients with IGBC than for those with NIGBC (11.4, 95% confidence interval, 5.6-13.7 vs 4.0, 95% confidence interval 3.03-5.96 months; p=0.01) during a median follow-up period of 5.7 months. Patients with IGBC showed better clinical prognosis than those with NIGBC. Therefore, patients with gallstone disease or gallbladder polyps, major predictive risk factors for IGBC, should undergo advanced work-up for chelecystectomy.

  1. Systematic review of outcome domains and instruments used in clinical trials of tinnitus treatments in adults.

    PubMed

    Hall, Deborah A; Haider, Haula; Szczepek, Agnieszka J; Lau, Pia; Rabau, Sarah; Jones-Diette, Julie; Londero, Alain; Edvall, Niklas K; Cederroth, Christopher R; Mielczarek, Marzena; Fuller, Thomas; Batuecas-Caletrio, Angel; Brueggemen, Petra; Thompson, Dean M; Norena, Arnaud; Cima, Rilana F F; Mehta, Rajnikant L; Mazurek, Birgit

    2016-06-01

    There is no evidence-based guidance to facilitate design decisions for confirmatory trials or systematic reviews investigating treatment efficacy for adults with tinnitus. This systematic review therefore seeks to ascertain the current status of trial designs by identifying and evaluating the reporting of outcome domains and instruments in the treatment of adults with tinnitus. Records were identified by searching PubMed, EMBASE CINAHL, EBSCO, and CENTRAL clinical trial registries (ClinicalTrials.gov, ISRCTN, ICTRP) and the Cochrane Database of Systematic Reviews. Eligible records were those published from 1 July 2006 to 12 March 2015. Included studies were those reporting adults aged 18 years or older who reported tinnitus as a primary complaint, and who were enrolled into a randomised controlled trial, a before and after study, a non-randomised controlled trial, a case-controlled study or a cohort study, and written in English. Studies with fewer than 20 participants were excluded. Two hundred and twenty-eight studies were included. Thirty-five different primary outcome domains were identified spanning seven categories (tinnitus percept, impact of tinnitus, co-occurring complaints, quality of life, body structures and function, treatment-related outcomes and unclear or not specified). Over half the studies (55 %) did not clearly define the complaint of interest. Tinnitus loudness was the domain most often reported (14 %), followed by tinnitus distress (7 %). Seventy-eight different primary outcome instruments were identified. Instruments assessing multiple attributes of the impact of tinnitus were most common (34 %). Overall, 24 different patient-reported tools were used, predominantly the Tinnitus Handicap Inventory (15 %). Loudness was measured in diverse ways including a numerical rating scale (8 %), loudness matching (4 %), minimum masking level (1 %) and loudness discomfort level (1 %). Ten percent of studies did not clearly report the instrument

  2. Endogenous Aspergillus endophthalmitis. Clinical features and treatment outcomes.

    PubMed

    Weishaar, P D; Flynn, H W; Murray, T G; Davis, J L; Barr, C C; Gross, J G; Mein, C E; McLean, W C; Killian, J H

    1998-01-01

    This study evaluated the clinical features and treatment outcomes in patients with endogenous Aspergillus endophthalmitis. The study design was a multicenter retrospective chart review. Ten patients (12 eyes) with culture-proven endogenous Aspergillus endophthalmitis treated by 1 of the authors were studied. Intravitreous amphotericin B injection, pars plana vitrectomy, systemic amphotericin B therapy, and oral anti-fungal therapy were performed. Elimination of endogenous Aspergillus endophthalmitis and Snellen visual acuity, best corrected, were measured. All patients had a 1- to 3-day history of pain and marked loss of visual acuity in the involved eyes. Varying degrees of vitritis was present in all 12 eyes. In 8 of 12 eyes, a central macular chorioretinal inflammatory lesion was present. Four patients (six eyes) had associated pulmonary diseases and were receiving concurrent steroid therapy. One of these patients with chronic asthma also was abusing intravenous drugs. Overall, six patients (six eyes) had a history of intravenous drug abuse, whereas a seventh patient (one eye) was suspected of abusing intravenous drugs. Blood cultures and echocardiograms were negative for systemic aspergillosis. Management consisted of a pars plana vitrectomy in 10 of 12 eyes. Intravitreous amphotericin B was administered in 11 of 12 eyes. Systemic amphotericin B therapy was used in eight patients. One patient was treated with oral antifungal agents. In three eyes without central macular involvement, final visual acuities were 20/25 to 20/200. In eight eyes with initial central macular involvement, final visual acuities were 20/400 in three eyes and 5/200 or less in four eyes. Two painful eyes with marked inflammation, hypotony, and retinal detachment were enucleated. Endogenous Aspergillus endophthalmitis usually has an acute onset of intraocular inflammation and often has a characteristic chorioretinal lesion located in the macula. Although treatment with pars plana vitrectomy

  3. US-guided percutaneous cholecystostomy: features predicting culture-positive bile and clinical outcome.

    PubMed

    Sosna, Jacob; Kruskal, Jonathan B; Copel, Laurian; Goldberg, S Nahum; Kane, Robert A

    2004-03-01

    To assess sonographic and clinical features that might be used to predict infected bile and/or patient outcome from ultrasonography (US)-guided percutaneous cholecystostomy. Between February 1997 and August 2002 at one institution, 112 patients underwent US-guided percutaneous cholecystostomy (59 men, 53 women; average age, 69.3 years). All US images were scored on a defined semiquantitative scale according to preset parameters: (a) gallbladder distention, (b) sludge and/or stones, (c) wall appearance, (d) pericholecystic fluid, and (e) common bile duct size and/or choledocholithiasis. Separate and total scores were generated. Retrospective evaluation of (a) the bacteriologic growth of aspirated bile and its color and (b) clinical indices (fever, white blood cell count, bilirubin level, liver function test results) was conducted by reviewing medical records. For each patient, the clinical manifestation was classified into four groups: (a) localized right upper quadrant symptoms, (b) generalized abdominal symptoms, (c) unexplained sepsis, or (d) sepsis with other known infection. Logistic regression models, exact Wilcoxon-Mann-Whitney test, and the Kruskal-Wallis test were used. Forty-seven (44%) of 107 patients had infected bile. A logistic regression model showed that wall appearance, distention, bile color, and pericholecystic fluid were not individually significant predictors for culture-positive bile, leaving sludge and/or stones (P =.003, odds ratio = 1.647), common bile duct status (P =.02, odds ratio = 2.214), and total score (P =.007, odds ratio = 1.267). No US covariates or clinical indices predicted clinical outcome. Clinical manifestation was predictive of clinical outcome (P =.001) and aspirating culture-positive bile (P =.008); specifically, 30 (86%) of 35 patients with right upper quadrant symptoms had their condition improve, compared with one (7%) of 15 asymptomatic patients with other known causes of infection. US variables can be used to predict

  4. Service profiling and outcomes benchmarking using the CORE-OM: toward practice-based evidence in the psychological therapies. Clinical Outcomes in Routine Evaluation-Outcome Measures.

    PubMed

    Barkham, M; Margison, F; Leach, C; Lucock, M; Mellor-Clark, J; Evans, C; Benson, L; Connell, J; Audin, K; McGrath, G

    2001-04-01

    To complement the evidence-based practice paradigm, the authors argued for a core outcome measure to provide practice-based evidence for the psychological therapies. Utility requires instruments that are acceptable scientifically, as well as to service users, and a coordinated implementation of the measure at a national level. The development of the Clinical Outcomes in Routine Evaluation-Outcome Measure (CORE-OM) is summarized. Data are presented across 39 secondary-care services (n = 2,710) and within an intensively evaluated single service (n = 1,455). Results suggest that the CORE-OM is a valid and reliable measure for multiple settings and is acceptable to users and clinicians as well as policy makers. Baseline data levels of patient presenting problem severity, including risk, are reported in addition to outcome benchmarks that use the concept of reliable and clinically significant change. Basic quality improvement in outcomes for a single service is considered.

  5. Effect of metallo-β-lactamase production and multidrug resistance on clinical outcomes in patients with Pseudomonas aeruginosa bloodstream infection: a retrospective cohort study

    PubMed Central

    2013-01-01

    Background Blood stream infections (BSI) with Pseudomonas aeruginosa lead to poor clinical outcomes. The worldwide emergence and spread of metallo-β-lactamase (MBL) producing, often multidrug-resistant organisms may further aggravate this problem. Our study aimed to investigate the effect of MBL-producing P. aeruginosa (MBL-PA) and various other resistance phenotypes on clinical outcomes. Methods A retrospective cohort study was conducted in three German hospitals. Medical files from 2006 until 2012 were studied, and a number of 113 patients with P. aeruginosa BSI were included. The presence of VIM, IMP and NDM genes was detected using molecular techniques. Genetic relatedness was assessed through multilocus sequence typing (MLST). The effect of resistance patterns or MBL production on clinical outcomes was investigated by using multivariate Cox regression models. Results In-hospital mortality was significantly higher in patients with MBL-PA and multidrug-resistant P. aeruginosa. However, neither BSI with MBL-PA nor BSI with various resistance phenotypes of P. aeruginosa were independently associated with mortality or length of hospital stay. In multivariate models, the SAPS II score (HR 1.046), appropriate definitive treatment (HR range 0.25-0.26), and cardiovascular disease (HR range 0.44-0.46) were independent predictors of mortality. Concomitant infections were associated with an excess length of stay (HR < 1). Conclusions Medication with appropriate antimicrobial agents at any time during the course of infection remains the key for improving clinical outcomes in patients with P. aeruginosa BSI and should be combined with a strict implementation of routine infection control measures. PMID:24176052

  6. Effect of metallo-β-lactamase production and multidrug resistance on clinical outcomes in patients with Pseudomonas aeruginosa bloodstream infection: a retrospective cohort study.

    PubMed

    Willmann, Matthias; Kuebart, Ines; Marschal, Matthias; Schröppel, Klaus; Vogel, Wichard; Flesch, Ingo; Markert, Uwe; Autenrieth, Ingo B; Hölzl, Florian; Peter, Silke

    2013-11-01

    Blood stream infections (BSI) with Pseudomonas aeruginosa lead to poor clinical outcomes. The worldwide emergence and spread of metallo-β-lactamase (MBL) producing, often multidrug-resistant organisms may further aggravate this problem. Our study aimed to investigate the effect of MBL-producing P. aeruginosa (MBL-PA) and various other resistance phenotypes on clinical outcomes. A retrospective cohort study was conducted in three German hospitals. Medical files from 2006 until 2012 were studied, and a number of 113 patients with P. aeruginosa BSI were included. The presence of VIM, IMP and NDM genes was detected using molecular techniques. Genetic relatedness was assessed through multilocus sequence typing (MLST). The effect of resistance patterns or MBL production on clinical outcomes was investigated by using multivariate Cox regression models. In-hospital mortality was significantly higher in patients with MBL-PA and multidrug-resistant P. aeruginosa. However, neither BSI with MBL-PA nor BSI with various resistance phenotypes of P. aeruginosa were independently associated with mortality or length of hospital stay. In multivariate models, the SAPS II score (HR 1.046), appropriate definitive treatment (HR range 0.25-0.26), and cardiovascular disease (HR range 0.44-0.46) were independent predictors of mortality. Concomitant infections were associated with an excess length of stay (HR < 1). Medication with appropriate antimicrobial agents at any time during the course of infection remains the key for improving clinical outcomes in patients with P. aeruginosa BSI and should be combined with a strict implementation of routine infection control measures.

  7. Pain One Week After an Emergency Department Visit for Acute Low Back Pain Is Associated With Poor Three-month Outcomes.

    PubMed

    Friedman, Benjamin W; Conway, John; Campbell, Caron; Bijur, Polly E; John Gallagher, E

    2018-05-16

    Low back pain (LBP) is responsible for more than 2.5 million visits to U.S. emergency departments (EDs) annually. Nearly 30% of patients who present to an ED with acute LBP report functional impairment or pain 3 months later. These patients are at risk of chronic LBP, a highly debilitating condition. In this study, we assessed whether three variables assessable shortly after symptom onset could independently predict poor 3-month outcomes among LBP patients who present to an ED. This was a planned analysis of data from two randomized comparative effectiveness studies of patients with acute, nontraumatic, nonradicular LBP. Patients were enrolled during an ED visit, contacted by telephone 1 week after the ED visit, and then followed up by telephone 3 months later. The coprimary 3-month outcomes were LBP-related functional impairment and persistent moderate or severe LBP. Two of the three hypothesized predictor variables were assessed during the index visit: 1) the STarT Back Screening Tool score, a nine-item, multidimensional tool validated and widely used in the outpatient setting, and 2) the patient's own anticipated duration of LBP. The third hypothesized predictor was presence of pain assessed by phone 1 week after the ED visit. We then determined whether these three predictor variables were independently associated with poor outcomes at 3 months, after controlling for medication received, age, and sex. A total of 354 patients were enrolled. Of these, 309 (87%) provided 3-month impairment data and 311 (88%) provided 3-month pain data. At 3 months, 122 of 309 (39%) patients reported functional impairment and 51 of 311(16%) patients reported moderate or severe LBP. Among the three hypothesized predictor variables, 58 of 352 (16%) patients with available data reported a moderate or high STarT Back Screening Tool score, 35 of 321 (11%) patients with available data reported anticipated duration of LBP > 1 week, and 235 of 346 (68%) patients reported pain at 1-week

  8. Caregiver-Child Verbal Interactions in Child Care: A Buffer against Poor Language Outcomes when Maternal Language Input is Less

    PubMed Central

    Vernon-Feagans, Lynne; Bratsch-Hines, Mary E.

    2013-01-01

    Recent research has suggested that high quality child care can buffer young children against poorer cognitive and language outcomes when they are at risk for poorer language and readiness skills. Most of this research measured the quality of parenting and the quality of the child care with global observational measures or rating scales that did not specify the exact maternal or caregiver behaviors that might be causally implicated in the buffering of these children from poor outcomes. The current study examined the actual language by the mother to her child in the home and the verbal interactions between the caregiver and child in the child care setting that might be implicated in the buffering effect of high quality childcare. The sample included 433 rural children from the Family Life Project who were in child care at 36 months of age. Even after controlling for a variety of covariates, including maternal education, income, race, child previous skill, child care type, the overall quality of the home and quality of the child care environment; observed positive caregiver-child verbal interactions in the child care setting interacted with the maternal language complexity and diversity in predicting children’s language development. Caregiver-child positive verbal interactions appeared to buffer children from poor language outcomes concurrently and two years later if children came from homes where observed maternal language complexity and diversity during a picture book task was less. PMID:24634566

  9. Blood urea nitrogen to serum creatinine ratio is an accurate predictor of outcome in diarrhea-associated hemolytic uremic syndrome, a preliminary study.

    PubMed

    Keenswijk, Werner; Vanmassenhove, Jill; Raes, Ann; Dhont, Evelyn; Vande Walle, Johan

    2017-03-01

    Diarrhea-associated hemolytic uremic syndrome (D+HUS) is a common thrombotic microangiopathy during childhood and early identification of parameters predicting poor outcome could enable timely intervention. This study aims to establish the accuracy of BUN-to-serum creatinine ratio at admission, in addition to other parameters in predicting the clinical course and outcome. Records were searched for children between 1 January 2008 and 1 January 2015 admitted with D+HUS. A complicated course was defined as developing one or more of the following: neurological dysfunction, pancreatitis, cardiac or pulmonary involvement, hemodynamic instability, and hematologic complications while poor outcome was defined by death or development of chronic kidney disease. Thirty-four children were included from which 11 with a complicated disease course/poor outcome. Risk of a complicated course/poor outcome was strongly associated with oliguria (p = 0.000006) and hypertension (p = 0.00003) at presentation. In addition, higher serum creatinine (p = 0.000006) and sLDH (p = 0.02) with lower BUN-to-serum creatinine ratio (p = 0.000007) were significantly associated with development of complications. A BUN-to-sCreatinine ratio ≤40 at admission was a sensitive and highly specific predictor of a complicated disease course/poor outcome. A BUN-to-serum Creatinine ratio can accurately identify children with D+HUS at risk for a complicated course and poor outcome. What is Known: • Oliguria is a predictor of poor long-term outcome in D+HUS What is New: • BUN-to-serum Creatinine ratio at admission is an entirely novel and accurate predictor of poor outcome and complicated clinical outcome in D+HUS • Early detection of the high risk group in D+HUS enabling early treatment and adequate monitoring.

  10. A Valuable Tool in Predicting Poor Outcome due to Sepsis in Pediatric Intensive Care Unit: Tp-e/QT Ratio.

    PubMed

    Ozdemir, Rahmi; Isguder, Rana; Kucuk, Mehmet; Karadeniz, Cem; Ceylan, Gokhan; Katipoglu, Nagehan; Yilmazer, Murat Muhtar; Yozgat, Yilmaz; Mese, Timur; Agin, Hasan

    2016-10-01

    To assess the feasibility of 12-lead electrocardiographic (ECG) measures such as P wave dispersion (PWd), QT interval, QT dispersion (QTd), Tp-e interval, Tp-e/QT and Tp-e/QTc ratio in predicting poor outcome in patients diagnosed with sepsis in pediatric intensive care unit (PICU). Ninety-three patients diagnosed with sepsis, severe sepsis or septic shock and 103 age- and sex-matched healthy children were enrolled into the study. PWd, QT interval, QTd, Tp-e interval and Tp-e/QT, Tp-e/QTc ratios were obtained from a 12-lead electrocardiogram. PWd, QTd, Tp-e interval and Tp-e/QT, Tp-e/QTc ratios were significantly higher in septic patients compared with the controls. During the study period, 41 patients had died. In multivariate logistic regression analyses, only Tp-e/QT ratio was found to be an independent predictor of mortality. The ECG measurements can predict the poor outcome in patients with sepsis. The Tp-e/QT ratio may be a valuable tool in predicting mortality for patients with sepsis in the PICU. © The Author [2016]. Published by Oxford University Press. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

  11. Predicting poor outcome following hepatectomy: analysis of 2313 hepatectomies in the NSQIP database

    PubMed Central

    Aloia, Thomas A; Fahy, Bridget N; Fischer, Craig P; Jones, Stephen L; Duchini, Andrea; Galati, Joseph; Gaber, A Osama; Ghobrial, R Mark; Bass, Barbara L

    2009-01-01

    Background: For the past two decades multiple series have documented that liver resection has become safer. The purpose of this study was to determine the current status of hepatic resection in the USA by analysing the multi-institutional experience within the National Surgical Quality Improvement Program (NSQIP) dataset. Methods: Of the 363 897 cases in the 2005–2007 NSQIP Participant Use File, 2313 elective open hepatectomy cases were identified (1344 partial, 230 left, 510 right and 229 extended hepatectomies). A total of 57 perioperative risk factors and 28 postoperative complications were compared. To determine the applicability of NSQIP general risk models to hepatic surgery, the prognostic value of standard multivariate analysis was compared with the NSQIP general surgery aggregate risk indices (expected probability of morbidity [morbprob], expected probability of mortality [mortprob]). Results: The median age of patients listed in the database was 60 years; sex distributions were equivalent; 78% were White; 65% of patients had an ASA score of 3 or 4, and the most prevalent co-morbidity was hypertension (46%). A total of 41% of patients had disseminated cancer, 19% of whom had received chemotherapy within 30 days of surgery. The overall 30-day mortality rate was 2.5% (57/2313) and the 30-day major morbidity rate was 19.6% (453/2313). Multivariate analysis identified nine risk factors associated with major morbidity and two risk factors associated with mortality. In contrast, the morbprob and mortprob statistics did not predict outcomes accurately. For those patients who developed major morbidity, the median length of stay was longer (10 vs. 6 days; P= 0.001) and the mortality rate was higher (11.3% vs. 0.3%; P= 0.001). Conclusions: Analysis of the NSQIP experience with hepatectomy indicates that the current mortality and major morbidity rate benchmarks are 2.5% and 19.6%, respectively. Poor outcomes were associated with nutritional status, liver function

  12. Outcome Measures in Myasthenia Gravis: Incorporation Into Clinical Practice.

    PubMed

    Muppidi, Srikanth

    2017-03-01

    The development of validated assessment tools for evaluating disease status and response to interventions in patients with myasthenia gravis (MG) has been driven by clinical studies of emerging MG therapies. However, only a small proportion of MG-focused neurology practices have adopted these assessment tools for routine clinical use. This article reviews the suitability of 5 assessment instruments for incorporation into clinical practice, which should be driven by their ability to contribute to improved patient outcomes, and to be implemented within practice personnel and resource constraints. It is recommended that assessments based on both physician-evaluated and patient-reported outcomes be selected, to adequately evaluate both point-in-time symptom load and functional impact of MG symptoms over time. Provider resource allocation and reimbursement issues may be the most significant roadblocks to successful ongoing use of these tools; to that end, the addition of regular assessments to MG standards of care is recommended.

  13. Clinical Parameters and Outcomes in Periorbital Necrotizing Fasciitis.

    PubMed

    Wladis, Edward J; Levin, Flora; Shinder, Roman

    2015-01-01

    To describe the clinical features associated with periorbital necrotizing fasciitis and to correlate these features with clinical outcomes. The case logs of 3 surgeons were used to identify cases of necrotizing fasciitis. Chart reviews were performed to characterize clinical metrics, and statistical analyses were performed. Seventeen patients (9 males, 8 females; mean age = 48.1 years, standard deviation = 22.6 years) were identified with periorbital necrotizing fasciitis. Of these patients, 52.9% did not have immunodeficiencies, and 52.9% did not have antecedent trauma or infected facial lesions. One patient died from necrotizing fasciitis. A history of immunosuppression correlated with the requirement for exenteration, but did not correlate visual acuity of worse than 20/40 upon discharge from the hospital. Most of the patients (68.75%) were discharged with visual acuity of better than 20/40 in the affected eye. This study represents the largest case series of patients with periorbital necrotizing fasciitis. Most of the patients in this series did not have immunodeficiencies, and the majority were discharged with favorable visual acuities. Nonetheless, a history of immunosuppression correlated with the need for exenteration, but was not statistically linked with worse visual outcomes.

  14. Interprofessional teamwork skills as predictors of clinical outcomes in a simulated healthcare setting.

    PubMed

    Shrader, Sarah; Kern, Donna; Zoller, James; Blue, Amy

    2013-01-01

    Teaching interprofessional (IP) teamwork skills is a goal of interprofessional education. The purpose of this study was to examine the relationship between IP teamwork skills, attitudes and clinical outcomes in a simulated clinical setting. One hundred-twenty health professions students (medicine, pharmacy, physician assistant) worked in interprofessional teams to manage a "patient" in a health care simulation setting. Students completed the Interdisciplinary Education Perception Scale (IEPS) attitudinal survey instrument. Students' responses were averaged by team to create an IEPS attitudes score. Teamwork skills for each team were rated by trained observers using a checklist to calculate a teamwork score (TWS). Clinical outcome scores (COS) were determined by summation of completed clinical tasks performed by the team based on an expert developed checklist. Regression analyses were conducted to determine the relationship of IEPS and TWS with COS. IEPS score was not a significant predictor of COS (p=0.054), but TWS was a significant predictor (p<0.001) of COS. Results suggest that in a simulated clinical setting, students' interprofessional teamwork skills are significant predictors of positive clinical outcomes. Interprofessional curricular models that produce effective teamwork skills can improve student performance in clinical environments and likely improve teamwork practice to positively affect patient care outcomes.

  15. Using an evidence-based approach to measure outcomes in clinical practice.

    PubMed

    MacDermid, Joy C; Grewal, Ruby; MacIntyre, Norma J

    2009-02-01

    Evaluation of the outcome of evidence-based practice decisions in individual patients or patient groups is step five in the evidence-based practice approach. Outcome measures are any measures that reflect patient status. Status or outcome measures can be used to detect change over time (eg, treatment effects), to discriminate among clinical groups, or to predict future outcomes (eg, return to work). A variety of reliable and valid physical impairment and disability measures are available to assess treatment outcomes in hand surgery and therapy. Evidence from research studies that includes normative data, standard error of measurement, or comparative scores for important clinical subgroups can be used to set treatment goals, monitor recovery, and compare individual patient outcomes to those reported in the literature. Clinicians tend to rely on impairment measures, such as radiographic measures, grip strength, and range of motion, although self-report measures are known to be equally reliable and more related to global effects, such as return-to-work. The process of selecting and implementing outcome measures is crucial. This process works best when team members are involved and willing to trial new measures. In this way, the team can develop customized outcome assessment procedures that meet their needs for assessing individual patients and providing data for program evaluation.

  16. Clinically Relevant Outcome Measures Following Limb Osseointegration; Systematic Review of the Literature.

    PubMed

    Al Muderis, Munjed M; Lu, William Y; Li, Jiao Jiao; Kaufman, Kenton; Orendurff, Michael; Highsmith, M Jason; Lunseth, Paul A; Kahle, Jason T

    2018-02-01

    The current standard of care for an amputee is a socket-based prostheses. An osseointegrated implant (OI) is an alternative for prosthetic attachment. Osseointegration addresses reported problems related to wearing a socket interface, such as skin issues, discomfort, diminished function, quality of life, prosthetic use, and abandonment. The purpose of this report is to systematically review current literature regarding OI to identify and categorize the reported clinically relevant outcome measures, rate the quality of available evidence, and synthesize the findings. A multidisciplinary team used PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) methods. Search methodology was based on identifying clinically relevant articles. Three databases were searched: PubMed, CINAHL, and Web of Science. Clinical studies with aggregated data reporting at least 1 clinically relevant outcome measure were included. The Grading of Recommendations Assessment, Development, and Evaluation (GRADE) criterion was used for critical appraisal and recommendations. This review identified 21 clinically relevant observational studies. Outcome measures were categorized into the following 9 categories: vibratory stimulation, complications, biomechanics, economics, patient-reported outcome measures, electromyography, x-ray, physical functional performance, and energy consumption. This systematic review consisted of Level III and IV observational studies. Homogeneous outcome measures with strong psychometric properties across prospective studies do not exist to date. Higher-level, prospective, randomized, long-term, clinically relevant trials are needed to prove efficacy of OI compared with socket prosthetic attachment. Osseointegration was at least equivalent to sockets in most studies. In some cases, it was superior. Osseointegration represents a promising alternative to socket prosthetic attachments for extremity amputees. Therapeutic Level III. See Instructions for

  17. Visual outcomes of bilateral congenital and developmental cataracts in young children in south India and causes of poor outcome.

    PubMed

    Khanna, Rohit C; Foster, Allen; Krishnaiah, Sannapaneni; Mehta, Manohar K; Gogate, Parikshit M

    2013-02-01

    Bilateral pediatric cataracts are important cause of visual impairment in children. To study the outcome of bilateral pediatric cataract surgery in young children. Retrospective case series in a tertiary center. Records of pediatric cataracts operated between January 2001 and December 2003, with a minimum follow-up of 3 months, were reviewed retrospectively. Independent sample t-test, Fisher's exact test, and logistic regression using SPSS (Statistical Package for Social Science, Chicago, USA) version 12. 215/257 (83.7%) patients had a minimum follow-up of 3 months. The mean age of presentation to the hospital was 53 months (range: 0-168 months). Congenital cataract was present in 107 patients (58.2%) and developmental cataract in 77 patients (41.8%). The mean age at surgery was 55.2 months (range: 1-168 months). Out of 430 eyes, 269 (62.6%) had an intraocular lens implanted. The mean duration of follow-up was 13.1 months (range: 3-38 months). Pre-operatively, 102 patients (47.3%) had visual acuity <6/60, in the better eye, compared to 37 patients (17.2%) post-operatively ( P < 0.001). Eighty-five patients (39.5%) had visual acuity >6/18. The most common early post-operative complication was fibrinous uveitis in 57 eyes (13.3%) and the most common delayed post-operative complication was posterior capsular opacification in 118 eyes (27.4%). The most important prognostic factor for poor outcome was congenital cataract (odds ratio [OR]: 26.3; 95% confidence interval [CI], 4.4-158.5) and total cataract (OR: 4.8; 95% CI, 1.3-17). Nearly half of the eyes had visual acuity >6/18. The outcome was poorer in congenital cataracts, especially those operated after >1 year of age.

  18. The impact of neutral-pH peritoneal dialysates with reduced glucose degradation products on clinical outcomes in peritoneal dialysis patients.

    PubMed

    Cho, Yeoungjee; Johnson, David W; Badve, Sunil V; Craig, Jonathan C; Strippoli, Giovanni F M; Wiggins, Kathryn J

    2013-11-01

    Neutral-pH peritoneal dialysates, with reduced glucose degradation products (GDPs), have been developed to reduce peritoneal membrane damage. Here our review evaluated the impact of these solutions on clinical outcomes using data from The Cochrane CENTRAL Registry, MEDLINE, Embase, and reference lists for randomized trials of biocompatible solutions. Summary estimates of effect were obtained using a random-effects model of 20 eligible trials encompassing 1383 patients. The quality of studies was generally poor, such that 13 studies had greater than a 20% loss to follow-up and only 3 trials reported adequate concealment of allocation. Use of neutral-pH dialysates with reduced GDPs resulted in larger urine volumes (7 trials; 520 patients; mean difference 126 ml/day, 95% CI 27-226), improved residual renal function after 12 months (6 trials; 360 patients; standardized mean difference 0.31, 95% confidence interval 0.10-0.52), and a trend to reduced inflow pain (1 trial; 58 patients; relative risk 0.51, 95% CI 0.24-1.08). However, there was no significant effect on body weight, hospitalization, peritoneal solute transport rate, peritoneal small-solute clearance, peritonitis, technique failure, patient survival, or adverse events. No significant harms were identified. Thus, based on generally poor quality trials, the use of neutral-pH peritoneal dialysates with reduced GDPs resulted in greater urine volumes and residual renal function after 12 months, but without other clinical benefits. Larger, better-quality studies are needed for accurate evaluation of the impact of these newer dialysates on patient-level hard outcomes.

  19. Intravenous thrombolysis and endovascular therapy for acute ischemic stroke with internal carotid artery occlusion: a systematic review of clinical outcomes.

    PubMed

    Mokin, Maxim; Kass-Hout, Tareq; Kass-Hout, Omar; Dumont, Travis M; Kan, Peter; Snyder, Kenneth V; Hopkins, L Nelson; Siddiqui, Adnan H; Levy, Elad I

    2012-09-01

    Strokes secondary to acute internal carotid artery (ICA) occlusion are associated with extremely poor prognosis. The best treatment approach to acute stroke in this setting is unknown. We sought to determine clinical outcomes in patients with acute ischemic stroke attributable to ICA occlusion treated with intravenous (IV) systemic thrombolysis or intra-arterial endovascular therapy. Using the PubMed database, we searched for studies that included patients with acute ischemic stroke attributable to ICA occlusion who received treatment with IV thrombolysis or intra-arterial endovascular interventions. Studies providing data on functional outcomes beyond 30 days and mortality and symptomatic intracerebral hemorrhage (sICH) rates were included in our analysis. We compared the proportions of patients with favorable functional outcomes, sICH, and mortality rates in the 2 treatment groups by calculating χ(2) and confidence intervals for odds ratios. We identified 28 studies with 385 patients in the IV thrombolysis group and 584 in the endovascular group. Rates of favorable outcomes and sICH were significantly higher in the endovascular group than the IV thrombolysis-only group (33.6% vs 24.9%, P=0.004 and 11.1% vs 4.9%, P=0.001, respectively). No significant difference in mortality rate was found between the groups (27.3% in the IV thrombolysis group vs 32.0% in the endovascular group; P=0.12). According to our systematic review, endovascular treatment of acute ICA occlusion results in improved clinical outcomes. A higher rate of sICH after endovascular treatment does not result in increased overall mortality rate.

  20. CD117 expression in operable oesophageal squamous cell carcinomas predicts worse clinical outcome

    PubMed Central

    Fan, Huijie; Yuan, Yuan; Wang, Junsheng; Zhou, Fuyou; Zhang, Mingzhi; Giercksky, Karl-Erik; Nesland, Jahn M; Suo, Zhenhe

    2013-01-01

    Aims To investigate the aberrant expression of CD117 in oesophageal squamous cell carcinoma (SCC) and its prognostic significance. Methods and results Immunohistochemical staining for CD117 was performed on tissue microarray and routine tissue sections from 157 oesophageal SCC patients and 10 normal oesophageal epithelia adjacent to tumour. The positive rate of CD117 expression was 29.9% in oesophageal SCC tissues, whereas no CD117 expression was detected in the 10 normal oesophageal epithelia. CD117 expression was significantly associated with T stage (P < 0.001), distant metastasis (P = 0.015), lymph node metastasis (P = 0.019), and clinical stage (P = 0.021). Progression-free survival in the patients with CD117-positive tumours was shorter than that in the patients with CD117-negative tumours (P = 0.010). In univariate analyses, CD117 expression was the most significant factor for overall survival of oesophageal SCC patients (P < 0.001), followed by lymph node metastasis (P = 0.001), T stage (P = 0.002), clinical stage (P = 0.006), distant metastasis (P = 0.020), and histological grade (P = 0.027). Multivariate analyses verified that CD117 expression was an independent prognostic marker for oesophageal SCC patients (P = 0.002). In addition, CD117 expression predicted poorer survival in patients without distant metastases. Conclusions CD117 expression in operable oesophageal SCC may be a valuable prognostic marker, and detection of its expression in clinical samples may be useful in defining a subclass of oesophageal SCCs with extremely poor clinical outcome, which may require a specially targeted treatment modality. PMID:23570416

  1. Practical Telemedicine for Veterans with Persistently Poor Diabetes Control: A Randomized Pilot Trial.

    PubMed

    Crowley, Matthew J; Edelman, David; McAndrew, Ann T; Kistler, Susan; Danus, Susanne; Webb, Jason A; Zanga, Joseph; Sanders, Linda L; Coffman, Cynthia J; Jackson, George L; Bosworth, Hayden B

    2016-05-01

    Telemedicine-based diabetes management improves outcomes versus clinic care but is seldom implemented by healthcare systems. In order to advance telemedicine-based management as a practical option for veterans with persistent poorly controlled diabetes mellitus (PPDM) despite clinic-based care, we evaluated a comprehensive telemedicine intervention that we specifically designed for delivery using existing Veterans Health Administration (VHA) clinical staffing and equipment. We conducted a 6-month randomized trial among 50 veterans with PPDM; all maintained hemoglobin A1c (HbA1c) levels continuously >9.0% for >1 year despite clinic-based management. Participants received usual care or a telemedicine intervention combining telemonitoring, medication management, self-management support, and depression management; existing VHA clinical staff delivered the intervention. Using linear mixed models, we examined HbA1c, diabetes self-care (measured by the Self-Care Inventory-Revised questionnaire), depression, and blood pressure. At baseline, the model-estimated common HbA1c intercept was 10.5%. By 6 months, estimated HbA1c had improved by 1.3% for intervention participants and 0.3% for usual care (estimated difference, -1.0%, 95% confidence interval [CI], -2.0%, 0.0%; p = 0.050). Intervention participants' diabetes self-care (estimated difference, 7.0; 95% CI, 0.1, 14.0; p = 0.047), systolic blood pressure (-7.7 mm Hg; 95% CI, -14.8, -0.6; p = 0.035), and diastolic blood pressure (-5.6 mm Hg; 95% CI, -9.9, -1.2; p = 0.013) were improved versus usual care by 6 months. Depressive symptoms were similar between groups. A comprehensive telemedicine intervention improved outcomes among veterans with PPDM despite clinic-based care. Because we specifically designed this intervention with scalability in mind, it may represent a practical, real-world strategy to reduce the burden of poor diabetes control among veterans.

  2. Patellofemoral arthritis treated with resurfacing implant: Clinical outcome and complications at a minimum two-year follow-up.

    PubMed

    Zicaro, Juan Pablo; Yacuzzi, Carlos; Astoul Bonorino, Juan; Carbo, Lisandro; Costa-Paz, Matias

    2017-12-01

    This study evaluated the clinical and radiographic outcomes of a series of patients treated with an anatomic inlay resurfacing implant, with a minimum two-year follow-up. Fifteen patients underwent patellofemoral-resurfacing procedures using a HemiCAP Wave Patellofemoral Inlay Resurfacing implant from 2010 to 2013. Clinical outcomes included: Visual Analog Scale (VAS), Lysholm score, Knee Society Score (KSS), and evaluation of Kujala, and Hospital for Special Surgery Patellofemoral score (HSS-PF). The postoperative complications were analyzed. Nineteen knees were evaluated; the average follow-up was 35.2months. Fourteen were women, with an average age of 54years. The pre-operative/postoperative clinical results presented a significant improvement: VAS 8/2.5, Lysholm 31.9/85.8, KSS 39.8/82.5, Kujala 32.1/79.3 and Hospital for Special Surgery Patellofemoral score (HSS-PF) 15.9/90.6. A total of 87% of patients were either satisfied or very satisfied with the overall outcome. There were no radiographic signs of loosening. Seven postoperative complications were recorded: two presented ongoing knee pain, one postoperative stiffness, one patellar bounce due to maltracking, two ilio-tibial band syndrome, and one tibial anterior tuberosity osteotomy nonunion. Two patients underwent a total knee arthroplasty conversion and were considered a failure. None of these complications were implant related. Patellofemoral inlay resurfacing for isolated patellofemoral arthritis was an effective and safe procedure with high levels of patient satisfaction. No mechanical implant failure was seen at a minimum two-year follow-up. This implant design appeared to be an alternative to the traditional patellofemoral prostheses. Concomitant osteochondral lesions, patellofemoral dysplasia or patellar maltracking might be poor prognostic factors for this type of implant. Copyright © 2017 Elsevier B.V. All rights reserved.

  3. What predicts performance during clinical psychology training?

    PubMed Central

    Scior, Katrina; Bradley, Caroline E; Potts, Henry W W; Woolf, Katherine; de C Williams, Amanda C

    2014-01-01

    Objectives While the question of who is likely to be selected for clinical psychology training has been studied, evidence on performance during training is scant. This study explored data from seven consecutive intakes of the UK's largest clinical psychology training course, aiming to identify what factors predict better or poorer outcomes. Design Longitudinal cross-sectional study using prospective and retrospective data. Method Characteristics at application were analysed in relation to a range of in-course assessments for 274 trainee clinical psychologists who had completed or were in the final stage of their training. Results Trainees were diverse in age, pre-training experience, and academic performance at A-level (advanced level certificate required for university admission), but not in gender or ethnicity. Failure rates across the three performance domains (academic, clinical, research) were very low, suggesting that selection was successful in screening out less suitable candidates. Key predictors of good performance on the course were better A-levels and better degree class. Non-white students performed less well on two outcomes. Type and extent of pre-training clinical experience on outcomes had varied effects on outcome. Research supervisor ratings emerged as global indicators and predicted nearly all outcomes, but may have been biased as they were retrospective. Referee ratings predicted only one of the seven outcomes examined, and interview ratings predicted none of the outcomes. Conclusions Predicting who will do well or poorly in clinical psychology training is complex. Interview and referee ratings may well be successful in screening out unsuitable candidates, but appear to be a poor guide to performance on the course. Practitioner points While referee and selection interview ratings did not predict performance during training, they may be useful in screening out unsuitable candidates at the application stage High school final academic performance

  4. Effectiveness of the clinical teaching associate model to improve clinical learning outcomes: a randomized controlled trial.

    PubMed

    Parchebafieh, Samaneh; Gholizadeh, Leila; Lakdizaji, Sima; Ghiasvandiyan, Shahrzad; Davoodi, Arefeh

    2014-01-01

    This study examined the effectiveness of the clinical teaching associate (CTA) model to improve clinical learning outcomes in nursing students. Students were randomly allocated to either the CTA (n = 28) or traditional training group (n = 32), and their clinical knowledge, skills, and satisfaction with the learning experience were assessed and compared. The results showed that the CTA model was equally effective in improving clinical knowledge, skills, and satisfaction of nursing students.

  5. Individual and community factors associated with geographic clusters of poor HIV care retention and poor viral suppression

    PubMed Central

    Eberhart, Michael G.; Yehia, Baligh R.; Hillier, Amy; Voytek, Chelsea D.; Fiore, Danielle J.; Blank, Michael; Frank, Ian; Metzger, David S.; Brady, Kathleen A.

    2015-01-01

    Background Previous analyses identified specific geographic areas in Philadelphia (hotspots) associated with negative outcomes along the HIV care continuum. We examined individual and community factors associated with residing in these hotspots. Methods Retrospective cohort of 1,404 persons newly diagnosed with HIV in 2008–2009 followed for 24 months after linkage to care. Multivariable regression examined associations between individual (age, sex, race/ethnicity, HIV transmission risk, and insurance status) and community (economic deprivation, distance to care, access to public transit, and access to pharmacy services) factors and the outcomes: residence in a hotspot associated with poor retention in care and residence in a hotspot associated with poor viral suppression. Results 24.4% and 13.7% of persons resided in hotspots associated with poor retention and poor viral suppression, respectively. For persons residing in poor retention hotspots, 28.3% were retained in care compared to 40.4% of those residing outside hotspots (p<0.05). Similarly, for persons residing in poor viral suppression hotspots, 51.4% achieved viral suppression compared to 75.3% of those outside hotspots (p<.0.05). Factors significantly associated with residence in a poor retention hotspots included: female sex, lower economic deprivation, greater access to public transit, shorter distance to medical care, and longer distance to pharmacies. Factors significantly associated with residence in a poor viral suppression hotspots included; female sex, higher economic deprivation, and shorter distance to pharmacies. Conclusions Individual and community-level associations with geographic hotspots may inform both content and delivery strategies for interventions designed to improve retention in care and viral suppression. PMID:25867777

  6. Individual and community factors associated with geographic clusters of poor HIV care retention and poor viral suppression.

    PubMed

    Eberhart, Michael G; Yehia, Baligh R; Hillier, Amy; Voytek, Chelsea D; Fiore, Danielle J; Blank, Michael; Frank, Ian; Metzger, David S; Brady, Kathleen A

    2015-05-01

    Previous analyses identified specific geographic areas in Philadelphia (hotspots) associated with negative outcomes along the HIV care continuum. We examined individual and community factors associated with residing in these hotspots. Retrospective cohort of 1404 persons newly diagnosed with HIV in 2008-2009 followed for 24 months after linkage to care. Multivariable regression examined associations between individual (age, sex, race/ethnicity, HIV transmission risk, and insurance status) and community (economic deprivation, distance to care, access to public transit, and access to pharmacy services) factors and the outcomes: residence in a hotspot associated with poor retention-in-care and residence in a hotspot associated with poor viral suppression. In total, 24.4% and 13.7% of persons resided in hotspots associated with poor retention and poor viral suppression, respectively. For persons residing in poor retention hotspots, 28.3% were retained in care compared with 40.4% of those residing outside hotspots (P < 0.05). Similarly, for persons residing in poor viral suppression hotspots, 51.4% achieved viral suppression compared with 75.3% of those outside hotspots (P < 0.0.05). Factors significantly associated with residence in poor retention hotspots included female sex, lower economic deprivation, greater access to public transit, shorter distance to medical care, and longer distance to pharmacies. Factors significantly associated with residence in poor viral suppression hotspots included female sex, higher economic deprivation, and shorter distance to pharmacies. Individual and community-level associations with geographic hotspots may inform both content and delivery strategies for interventions designed to improve retention-in-care and viral suppression.

  7. The impact of Public Reporting on clinical outcomes: a systematic review and meta-analysis.

    PubMed

    Campanella, Paolo; Vukovic, Vladimir; Parente, Paolo; Sulejmani, Adela; Ricciardi, Walter; Specchia, Maria Lucia

    2016-07-22

    To assess both qualitatively and quantitatively the impact of Public Reporting (PR) on clinical outcomes, we carried out a systematic review of published studies on this topic. Pubmed, Web of Science and SCOPUS databases were searched to identify studies published from 1991 to 2014 that investigated the relationship between PR and clinical outcomes. Studies were considered eligible if they investigated the relationship between PR and clinical outcomes and comprehensively described the PR mechanism and the study design adopted. Among the clinical outcomes identified, meta-analysis was performed for overall mortality rate which quantitative data were exhaustively reported in a sufficient number of studies. Two reviewers conducted all data extraction independently and disagreements were resolved through discussion. The same reviewers evaluated also the quality of the studies using a GRADE approach. Twenty-seven studies were included. Mainly, the effect of PR on clinical outcomes was positive. Meta-analysis regarding overall mortality included, in a context of high heterogeneity, 10 studies with a total of 1,840,401 experimental events and 3,670,446 control events and resulted in a RR of 0.85 (95 % CI, 0.79-0.92). The introduction of PR programs at different levels of the healthcare sector is a challenging but rewarding public health strategy. Existing research covering different clinical outcomes supports the idea that PR could, in fact, stimulate providers to improve healthcare quality.

  8. Clinical and radiological features of Marchiafava–Bignami disease

    PubMed Central

    Dong, Xiaoyu; Bai, Chaobo; Nao, Jianfei

    2018-01-01

    Abstract Marchiafava–Bignami disease (MBD) is a rare neurological disease usually associated with chronic alcoholism and characterized by demyelination and necrosis. Our aims were to describe the clinicoradiological features and identify factors that may affect the prognosis of patients with MBD. We examined clinical manifestations, laboratory results, and neuroradiological features of 9 patients with MBD. The patients were classified into 2 subgroups (favorable and poor outcome subgroups) based on the Modified Oxford Handicap Scale (MOSH). In addition, we compared the clinical and neuroimaging features between the 2 subgroups. Nine adult male patients (age of onset range 37–62 years, with a mean age of 47.00 ± 14.50 years) were included in this study. According to MOSH, 4 patients were placed in the poor outcome subgroup (MOHS ≥ 3), 5 patients were placed in the favorable outcome subgroup (MOHS ≤ 2). Relatively high score of MAST-C (≥6) (P = .008), extracallosal lesions (P = .048), GCS (P = .026), cerebral lobe impairment (P = .048) was significantly more common in the poor outcome subgroup. Clinical manifestations of MBD are variable and lack specificity. Early diagnosis by relatively specific performance of bisymmetric lesions in corpus callosum of diffusion-weighted imaging (DWI) may affect the prognosis. The prognosis of patients with severe disturbance of consciousness, heavy alcohol consumption, extracallosal lesions, cerebral lobe impairment is probably unfavorable. PMID:29384842

  9. Reliability of gadolinium-enhanced magnetic resonance imaging findings and their correlation with clinical outcome in patients with sciatica.

    PubMed

    el Barzouhi, Abdelilah; Vleggeert-Lankamp, Carmen L A M; Lycklama à Nijeholt, Geert J; Van der Kallen, Bas F; van den Hout, Wilbert B; Koes, Bart W; Peul, Wilco C

    2014-11-01

    Gadolinium-enhanced magnetic resonance imaging (Gd-MRI) is often performed in the evaluation of patients with persistent sciatica after lumbar disc surgery. However, correlation between enhancement and clinical findings is debated, and limited data are available regarding the reliability of enhancement findings. To evaluate the reliability of Gd-MRI findings and their correlation with clinical findings in patients with sciatica. Prospective observational evaluation of patients who were enrolled in a randomized trial with 1-year follow-up. Patients with 6- to 12-week sciatica, who participated in a multicentre randomized clinical trial comparing an early surgery strategy with prolonged conservative care with surgery if needed. In total 204 patients underwent Gd-MRI at baseline and after 1 year. Patients were assessed by means of the Roland Disability Questionnaire (RDQ) for sciatica, visual analog scale (VAS) for leg pain, and patient-reported perceived recovery at 1 year. Kappa coefficients were used to assess interobserver reliability. In total, 204 patients underwent Gd-MRI at baseline and after 1 year. Magnetic resonance imaging findings were correlated to the outcome measures using the Mann-Whitney U test for continuous data and Fisher exact tests for categorical data. Poor-to-moderate agreement was observed regarding Gd enhancement of the herniated disc and compressed nerve root (kappa<0.41), which was in contrast with excellent interobserver agreement of the disc level of the herniated disc and compressed nerve root (kappa>0.95). Of the 59 patients with an enhancing herniated disc at 1 year, 86% reported recovery compared with 100% of the 12 patients with nonenhancing herniated discs (p=.34). Of the 12 patients with enhancement of the most affected nerve root at 1 year, 83% reported recovery compared with 85% of the 192 patients with no enhancement (p=.69). Patients with and without enhancing herniated discs or nerve roots at 1 year reported comparable

  10. Mental Health Medication Use Correlates with Poor Outcome After Femoroacetabular Impingement Surgery in a Military Population.

    PubMed

    Ernat, J J; Song, D J; Brugman, S C; Shaha, S H; Tokish, J M; Lee, G Y

    2015-08-05

    Femoroacetabular impingement is a common cause of hip pain in young adults. Several preoperative risk factors for poor outcomes with surgery have been identified; however, to our knowledge, no study has attempted to determine the effect of psychiatric comorbidity on outcomes with femoroacetabular impingement surgery. A retrospective review was performed on active-duty patients at one institution undergoing surgery for femoroacetabular impingement over five years. Medical records were reviewed for demographic characteristics, radiographic data, and history of mental health medication use. Return-to-duty status was considered the primary outcome measure. Outcome scores obtained included modified Harris hip scores, Single Assessment Numeric Evaluation scores, Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scores, patient satisfaction, and Veterans RAND-12 scores. Patients taking mental health medication were compared with those who were not with regard to return to duty and validated patient-reported outcome measures. Ninety-three patients (mean age, 32.2 years) were available for follow-up at a mean duration of 3.6 years. Of the seventeen patients discharged from service postoperatively, twelve (71%) were taking mental health medications. One-third (twenty-five) of seventy-six patients who returned to duty were taking mental health medication and this difference was significant (p < 0.006). Patients taking mental health medication had significantly poorer modified Harris hip scores (p < 0.02), WOMAC scores (p < 0.0008), and Veterans RAND-12 mental scores (p < 0.001). Antidepressant, antipsychotic, and multiple mental health medication use were all predictive of medical discharge due to hip pain. Psychiatric comorbidities are an important risk factor in active-duty military personnel undergoing surgery for femoroacetabular impingement. Mental health medication use is associated with poorer outcome scores and can significantly lower the

  11. Clinical outcomes with daptomycin: a post-marketing, real-world evaluation.

    PubMed

    Sakoulas, G

    2009-12-01

    The Cubicin Outcomes Registry and Experience (CORE) is an ongoing, retrospective, post-marketing database of daptomycin use in the USA. Although non-comparative, CORE offers insight into real-life clinical experience with daptomycin in various Gram-positive infections and specific patient types. Analyses of daptomycin treatment outcomes using the CORE database revealed that treatment with daptomycin has resulted in high rates of clinical success for a variety of Gram-positive infections, including indicated infections such as complicated skin and soft tissue infections, Staphylococcus aureus bacteraemia and right-sided infective endocarditis, and non-indicated infections such as osteomyelitis. Treatment outcomes did not differ significantly according to the causative pathogen for any of the analyses performed and were not influenced by the vancomycin MIC. Patients frequently received therapy with alternative antibiotics prior to treatment with daptomycin, particularly those patients with more serious infections. However, similar treatment outcomes were observed when daptomycin was used as first-line therapy or as salvage therapy, demonstrating the effectiveness of daptomycin in the treatment of these patients.

  12. Health literacy and patient outcomes in chronic kidney disease: a systematic review.

    PubMed

    Taylor, Dominic M; Fraser, Simon; Dudley, Chris; Oniscu, Gabriel C; Tomson, Charles; Ravanan, Rommel; Roderick, Paul

    2017-11-20

    Limited health literacy affects 25% of people with chronic kidney disease (CKD), and may reduce self-management skills resulting in poorer clinical outcomes. By disproportionately affecting people with low socio-economic status and non-white ethnicity, limited health literacy may promote health inequity. We performed a systematic review of quantitative studies of health literacy and clinical outcomes among adults with CKD. A total of 29 studies (13 articles; 16 conference abstracts) were included. One included non-USA patients. Of the 29 studies, 5 were cohort studies and 24 were cross-sectional. In all, 18 300 patients were studied: 4367 non-dialysis CKD; 13 202 dialysis; 390 transplant; 341 unspecified. Median study size was 127 [interquartile range (IQR) 92-238)], but 480 (IQR 260-2392) for cohort studies. Median proportion of non-white participants was 48% (IQR 17-70%). Six health literacy measures were used. Outcomes included patient attributes, care processes, clinical/laboratory parameters and 'hard' clinical outcomes. Limited health literacy was significantly, independently associated with hospitalizations, emergency department use, missed dialysis sessions, cardiovascular events and mortality (in cohort studies). Study quality was high (1 study), moderate (3 studies) and poor (25 studies), limited by sampling methods, variable adjustment for confounders and reduced methodological detail given in conference abstracts. There is limited robust evidence of the causal effects of health literacy on patient outcomes in CKD. Available evidence suggests associations with adverse clinical events, increased healthcare use and mortality. Prospective studies are required to determine the causal effects of health literacy on outcomes in CKD patients, and examine the relationships between socio-economic status, comorbidity, health literacy and CKD outcomes. Intervention development and evaluation will determine whether health literacy is a modifiable determinant of

  13. Clinical Prediction of Functional Outcome after Ischemic Stroke: The Surprising Importance of Periventricular White Matter Disease and Race

    PubMed Central

    Kissela, Brett; Lindsell, Christopher J.; Kleindorfer, Dawn; Alwell, Kathleen; Moomaw, Charles J.; Woo, Daniel; Flaherty, Matthew L.; Air, Ellen; Broderick, Joseph; Tsevat, Joel

    2009-01-01

    Background We sought 0074o build models that address questions of interest to patients and families by predicting short- and long-term mortality and functional outcome after ischemic stroke, while allowing for risk re-stratification as comorbid events accumulate. Methods A cohort of 451 ischemic stroke subjects in 1999 were interviewed during hospitalization, at 3 months, and at approximately 4 years. Medical records from the acute hospitalization were abstracted. All hospitalizations for 3 months post-stroke were reviewed to ascertain medical and psychiatric comorbidities, which were categorized for analysis. Multivariable models were derived to predict mortality and functional outcome (modified Rankin Scale) at 3 months and 4 years. Comorbidities were included as modifiers of the 3 month models, and included in 4-year predictions. Results Post-stroke medical and psychiatric comorbidities significantly increased short term post-stroke mortality and morbidity. Severe periventricular white matter disease (PVWMD) was significantly associated with poor functional outcome at 3 months, independent of other factors, such as diabetes and age; inclusion of this imaging variable eliminated other traditional risk factors often found in stroke outcomes models. Outcome at 3 months was a significant predictor of long-term mortality and functional outcome. Black race was a predictor of 4-year mortality. Conclusions We propose that predictive models for stroke outcome, as well as analysis of clinical trials, should include adjustment for comorbid conditions. The effects of PVWMD on short-term functional outcomes and black race on long-term mortality are findings that require confirmation. PMID:19109548

  14. Radiation Therapy Noncompliance and Clinical Outcomes in an Urban Academic Cancer Center

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

    Ohri, Nitin; Rapkin, Bruce D.; Guha, Chandan

    Purpose: To examine associations between radiation therapy (RT) noncompliance and clinical outcomes. Methods and Materials: We reviewed all patients who completed courses of external beam RT with curative intent in our department from the years 2007 to 2012 for cancers of the head and neck, breast, lung, cervix, uterus, or rectum. Patients who missed 2 or more scheduled RT appointments (excluding planned treatment breaks) were deemed noncompliant. Univariate, multivariable, and propensity-matched analyses were performed to examine associations between RT noncompliance and clinical outcomes. Results: Of 1227 patients, 266 (21.7%) were noncompliant. With median follow-up of 50.9 months, 108 recurrences (8.8%) and 228more » deaths (18.6%) occurred. In univariate analyses, RT noncompliance was associated with increased recurrence risk (5-year cumulative incidence 16% vs 7%, P<.001), inferior recurrence-free survival (5-year actuarial rate 63% vs 79%, P<.001), and inferior overall survival (5-year actuarial rate 72% vs 83%, P<.001). In multivariable analyses that were adjusted for disease site and stage, comorbidity score, gender, ethnicity, race, and socioeconomic status (SES), RT noncompliance was associated with inferior recurrence, recurrence-free survival, and overall survival rates. Propensity score–matched models yielded results nearly identical to those seen in univariate analyses. Low SES was associated with RT noncompliance and was associated with inferior clinical outcomes in univariate analyses, but SES was not associated with inferior outcomes in multivariable models. Conclusion: For cancer patients being treated with curative intent, RT noncompliance is associated with inferior clinical outcomes. The magnitudes of these effects demonstrate that RT noncompliance can serve as a behavioral biomarker to identify high-risk patients who require additional interventions. Treatment compliance may mediate the associations that have been observed linking SES

  15. Characteristics and clinical outcomes of repeat endovascular therapy after infrapopliteal balloon angioplasty in patients with critical limb ischemia.

    PubMed

    Kobayashi, Norihiro; Hirano, Keisuke; Yamawaki, Masahiro; Araki, Motoharu; Sakai, Tsuyoshi; Sakamoto, Yasunari; Mori, Shinsuke; Tsutsumi, Masakazu; Honda, Yohsuke; Tokuda, Takahiro; Makino, Kenji; Shirai, Shigemitsu; Ito, Yoshiaki

    2018-02-15

    We clarified characteristics and clinical outcomes of critical limb ischemia (CLI) patients who underwent repeat endovascular therapy (EVT) for infrapopliteal lesions. High restenosis rate after infrapopliteal EVT remains a major concern. Patients with CLI who underwent EVT between April 2007 and February 2014, were divided into the following three groups according to how often EVT was repeated: Group A, no repeat of EVT; Group B, EVT repeated once/twice; and Group C, EVT repeated ≥3 times. Wound healing rates at 1 year were 93.9% in Group A, 77.1% in Group B, and 27.3% in Group C (P < 0.001). Limb salvage rates at 3 years were 93.0, 88.5, and 57.1%, respectively (P = 0.001). Amputation-free survival rates at 3 years were 60.8, 51.2, and 29.2%, respectively (P = 0.019). Multivariate analysis revealed that hemodialysis (OR 3.413, 95% CI 1.263-9.225, P = 0.016), low ejection fraction (OR 7.758, 1.049-57.360, P = 0.045), and clinical stage assessed by SVS WIfI (OR 2.440, 1.417-4.203, P = 0.001) were independent predictors of repeat EVT. The rate of requirement for repeat EVT significantly increased as clinical stage became more severe (repeat EVT rate: 0% in CS 1, 28.6% in CS 2, 34.0% in CS 3, and 45.7% in CS 4, P < 0.001). The clinical outcomes of CLI patients requiring repeat EVT three or more times were poor. The SVS WIfI clinical stage may be useful to predict the necessity of repeat EVT. © 2017 Wiley Periodicals, Inc.

  16. Reaching clinically relevant outcome measures for new pharmacotherapy and immunotherapy of atopic eczema.

    PubMed

    Chalmers, Joanne; Deckert, Stefanie; Schmitt, Jochen

    2015-06-01

    This article describes the core outcome set (COS) for atopic eczema trials. COS describe a minimum set of outcomes to be assessed in a defined situation. COS are required to overcome the current situation of different trials using different endpoints with unclear/insufficient measurement properties resulting in incomparable trials. The global multi-stakeholder Harmonising Outcomes Measures for Eczema initiative developed the Harmonising Outcomes Measures for Eczema roadmap as a generic framework for COS development. Following the establishment of a panel representing all stakeholders, a core set of outcome domains need to be selected based on systematic reviews and consensus methods. Outcome measurement instruments to assess these core domains need to be valid, reliable, and feasible. There is broad global consensus that clinical signs, quality of life, symptoms, and long-term control of flares form the COS for atopic eczema trials. The Eczema Area and Severity Index is recommended to assess clinical signs in atopic eczema trials. Systematic reviews to identify adequate outcome measurement instruments for the other core outcome domains are underway. Clinical signs should be assessed in all atopic eczema trials by at least the Eczema Area and Severity Index. Quality of life, symptoms, and flares should also be assessed in all atopic eczema trials by a valid, reliable, and feasible instrument.

  17. Rupture during coiling of intracranial aneurysms: Predictors and clinical outcome.

    PubMed

    Kocur, Damian; Przybyłko, Nikodem; Bażowski, Piotr; Baron, Jan

    2018-02-01

    The intraprocedural aneurysm rupture (IPR) is one of the most feared adverse effect associated with the coil embolization therapy. The aim of the study was to identify predisposing factors for IPR, as well as to define patient groups with worse clinical outcome following IPR. From February 2008 to March 2015, 273 consecutive patients were treated at our institution via endovascular coil embolization. Patient medical records were reviewed with emphasis on procedure description, potential risk factors and clinical outcomes related to IPR. The IPR occurred in 14 (5.13%) cases. Multivariate logistic regression models were used to determine independent predictors of IPR. Clinical outcome was analyzed using the Glasgow Outcome Scale (GOS). Multivariate analysis showed that aneurysm location at posterior communicating artery is an independent risk factor for IPR (p = 0.035; OR 3.5; 95%CI 1.09-11.26). The frequencies of favorable disability (GOS 4-5), severe disability (GOS 2-3), and mortality (GOS 1) between patients with IPR and without IPR were significantly different in the general study population (p < 0.001, p < 0.001 and p = 0.023, respectively) and in patients with previously unruptured aneurysms (p < 0.001, p = 0.006 and p = 0.003, respectively) but not in patients with previously ruptured aneurysms (p = 0.187, p = 0.089 and p = 1.0, respectively). Posterior communicating artery aneurysm location is an independent predictor for IPR. IPR is associated with a significant clinical deterioration in a subgroup of patients with previously unruptured aneurysms, but not in patients with ruptured aneurysms. Copyright © 2018 Elsevier B.V. All rights reserved.

  18. MYC copy number gains are associated with poor outcome in penile squamous cell carcinoma.

    PubMed

    Masferrer, Emili; Ferrándiz-Pulido, Carla; Lloveras, Belén; Masferrer-Niubò, Magalí; Espinet, Blanca; Salido, Marta; Rodríguez-Rivera, María; Alemany, Laia; Placer, Jose; Gelabert, Antoni; Servitje, Octavi; García-Patos, Vicenç; Pujol, Ramon M; Toll, Agustí

    2012-11-01

    We determined MYC gene numerical aberrations and protein expression at different stages of penile squamous cell carcinoma carcinogenesis. We correlated these findings with clinicopathological parameters and HPV infection. We evaluated 79 cases of penile squamous cell carcinoma, including 11 in situ and 68 invasive carcinomas. The MYC cytogenetic profile was evaluated by fluorescence in situ hybridization. HPV was detected by polymerase chain reaction amplification. MYC gains were identified in 4 of 11 in situ carcinomas (36%) and 50 of 68 invasive penile squamous cell carcinomas (73%). A significant association between MYC gains, and tumor progression and poor outcome was demonstrated (p <0.05). HPV DNA was detected in 32 of 79 penile squamous cell carcinomas (39%). High risk type 16 was the most prevalent type. MYC numerical aberrations did not correlate with HPV status. A significant association between HPV and MYC protein over expression was noted. In HPV negative cases MYC gains correlated with MYC over expression. MYC gains progressively increased during penile squamous cell carcinoma progression from in situ samples to metastases. MYC gains were an independent factor for poor prognosis. These findings were independent of HPV infection. MYC expression was increased in samples with HPV infection, probably reflecting direct activation of MYC. Copyright © 2012 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.

  19. Gender differences in clinical, immunological, and virological outcomes in highly active antiretroviral-treated HIV–HCV coinfected patients

    PubMed Central

    Emery, Joel; Pick, Neora; Mills, Edward J; Cooper, Curtis L

    2010-01-01

    Objective: The influence of biological sex on human immunodeficiency virus (HIV) antiretroviral treatment outcome is not well described in HIV–hepatitis C (HCV) coinfection. Methods: We assessed patients’ clinical outcomes of HIV–HCV coinfected patients initiating antiretroviral therapy attending the Ottawa Hospital Immunodeficiency Clinic from January 1996 to June 2008. Results: We assessed 144 males and 39 females. Although similar in most baseline characteristics, the CD4 count was higher in females (375 vs 290 cells/μL). Fewer females initiated ritonavir-boosted regimens. The median duration on therapy before interruption or change was longer in males (10 versus 4 months) (odds ratio [OR] 1.40 95% confidence interval: 0.95–2.04; P = 0.09). HIV RNA suppression was frequent (74%) and mean CD4 count achieved robust (over 400 cells/μL) at 6 months, irrespective of sex. The primary reasons for therapy interruption in females and males included: gastrointestinal intolerance (25% vs 19%; P = 0.42); poor adherence (22% vs 15%; P = 0.31); neuropsychiatric symptoms (19% vs 5%; P = 0.003); and lost to follow-up (3% vs 13%; P = 0.08). Seven males (5%) and no females discontinued therapy for liver-specific complications. Death rate was higher in females (23% vs 7%; P = 0.003). Conclusion: There are subtle differences in the characteristics of female and male HIV–HCV coinfected patients that influence HIV treatment decisions. The reasons for treatment interruption and change differ by biological sex. This knowledge should be considered when starting HIV therapy and in efforts to improve treatment outcomes. PMID:20517470

  20. Clinical features and outcome of cerebral abscess in congenital heart disease.

    PubMed

    Mehnaz, Atiq; Syed, Ahmed Umair; Saleem, Allana Salman; Khalid, Chishti N

    2006-01-01

    Cerebral abscess is a serious life threatening complication of several diseases. The objective of this study was to look at the clinical profile, microbiology and outcome of children with cerebral abscess having an underlying congenital heart disease as compared to other predisposing conditions. Thirty children aged less than 15 years were reviewed. There were 15 males and 15 females. The mean age of presentation was 5.6 +/- 4.4 years. The duration of illness at the time of admission was 17.6 +/- 24.6 days. Typically patients presented with fever, vomiting, headache and seizures. The predisposing conditions found were cyanotic congenital heart disease in 11 (37%) of children, meningitis in 6 (20%), septicemia in 7 (23%) and no underlying cause was found in 5 (17%) children. The most common microbe in children with cyanotic congenital heart disease was of the Streptococcus milleri group (52%). Computerized tomography confirmed the diagnosis and the most common location of the abscess was the parietal lobe of the cerebral hemisphere. All abscesses were large, more than 2 cm in diameter and were aspirated surgically. Excision was performed in 6 children. Five children expired, one due to a intracranial bleeding and the others due to severe cerebral edema and tentorial herniation. Complications were seen in 20 children and 16 had sequelae, hemiparesis in 11 and seizure disorder in 5. Brain abscess is a serious infection with poor outcome if diagnosed late. Delayed surgical drainage has high morbidity and mortality. The threshold for diagnosis should be low particularly in children with a predisposing condition like cyanotic congenital heart disease.

  1. Scrub typhus: Clinical spectrum and outcome.

    PubMed

    Venkategowda, Pradeep M; Rao, S Manimala; Mutkule, Dnyaneshwar P; Rao, Mallela V; Taggu, Alai N

    2015-04-01

    Scrub typhus is one of the differential diagnoses for fever with thrombocytopenia. ARDS associated with Scrub typhus has high morbidity and mortality. To evaluate clinical features, lab values, and outcome in patients with scrub typhus and comparison in patients with or without ARDS. 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. 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. 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.

  2. Time-courses of plasma IL-6 and HMGB-1 reflect initial severity of clinical presentation but do not predict poor neurologic outcome following subarachnoid hemorrhage.

    PubMed

    Kiiski, Heikki; Långsjö, Jaakko; Tenhunen, Jyrki; Ala-Peijari, Marika; Huhtala, Heini; Hämäläinen, Mari; Moilanen, Eeva; Öhman, Juha; Peltola, Jukka

    2017-03-01

    Patients with aneurysmal subarachnoid hemorrhage (aSAH) experience high mortality and morbidity. Neuroinflammation causes brain damage expansion after aSAH. Due to the complexity of the inflammatory response multiple biomarkers are needed to evaluate its' progression. We studied inflammatory process after aSAH by measuring two inflammatory biomarkers, interleukin-6 (IL-6) and high-mobility group box 1 (HMGB1) at simultaneous time-points after aSAH. In this prospective population-based study, IL-6 and HMGB1 were measured in aSAH patients (n = 47) for up to five days. Plasma concentrations of IL-6 and HMGB1 were measured at 0, 12 and 24 h after hospital admission, and thereafter daily for up to five days or until the patient was transferred from the intensive care unit (ICU). The patients' neurological outcomes were evaluated with the modified Rankin Scale at six months after aSAH. A high IL-6 level during the first day after aSAH was associated with a severe initial clinical presentation (p = 0.002) and infection during follow-up (p = 0.031). The HMGB1 level did not associate with these parameters. There was no correlation between IL-6 and HMGB1 levels at any time point during the follow-up. The concentrations of IL-6 and HMGB1 were not associated with neurological outcome. High initial IL-6 values seem to reflect the intensity of the inflammatory response but not the brain damage per se. An early inflammatory response might even be beneficial since although elevated IL-6 levels were observed in patients with a more severe initial clinical presentation, they were not associated with neurological outcome. The lack of correlation between IL-6 and HMGB1 questions the role of macrophages in the process of the secretion of these inflammatory markers after aSAH, instead pointing to the activation of alternative pro-inflammatory pathways.

  3. Poor Outcomes in a Cohort of HIV-Infected Adolescents Undergoing Treatment for Multidrug-Resistant Tuberculosis in Mumbai, India

    PubMed Central

    Isaakidis, Petros; Paryani, Roma; Khan, Samsuddin; Mansoor, Homa; Manglani, Mamta; Valiyakath, Asmaa; Saranchuk, Peter; Furin, Jennifer

    2013-01-01

    Background Little is known about the treatment of multidrug-resistant tuberculosis (MDR-TB) in HIV-co-infected adolescents. This study aimed to present the intermediate outcomes of HIV-infected adolescents aged 10–19 years receiving second-line anti-TB treatment in a Médecins Sans Frontières (MSF) project in Mumbai, India. Methods A retrospective review of medical records of 11 adolescents enrolled between July 2007 and January 2013 was undertaken. Patients were initiated on either empirical or individualized second-line ambulatory anti-TB treatment under direct observation. Results The median age was 16 (IQR 14–18) years and 54% were female. Five (46%) adolescents had pulmonary TB (PTB), two (18%) extrapulmonary disease (EPTB) and four (36%) had both. Median CD4 count at the time of MDR-TB diagnosis was 162.7 cells/µl (IQR: 84.8–250.5). By January 2013, eight patients had final and 3 had interim outcomes. Favourable results were seen in four (36.5%) patients: one was cured and three were still on treatment with negative culture results. Seven patients (64%) had poor outcomes: four (36.5%) died and three (27%) defaulted. Three of the patients who died never started on antiretroviral and/or TB treatment and one died 16 days after treatment initiation. Two of the defaulted died soon after default. All patients (100%) on-treatment experienced adverse events (AEs): two required permanent discontinuation of the culprit drug and two were hospitalized due to AEs. No patient required permanent discontinuation of the entire second-line TB or antiretroviral regimens. Conclusions Early mortality and mortality after default were the most common reasons for poor outcomes in this study. Early mortality suggests the need for rapid diagnosis and prompt treatment initiation, and adolescents might benefit from active contact-tracing and immediate referral. Default occurred at different times, suggesting the need for continuous, intensified and individualized psychosocial

  4. Poor outcomes in a cohort of HIV-infected adolescents undergoing treatment for multidrug-resistant tuberculosis in Mumbai, India.

    PubMed

    Isaakidis, Petros; Paryani, Roma; Khan, Samsuddin; Mansoor, Homa; Manglani, Mamta; Valiyakath, Asmaa; Saranchuk, Peter; Furin, Jennifer

    2013-01-01

    Little is known about the treatment of multidrug-resistant tuberculosis (MDR-TB) in HIV-co-infected adolescents. This study aimed to present the intermediate outcomes of HIV-infected adolescents aged 10-19 years receiving second-line anti-TB treatment in a Médecins Sans Frontières (MSF) project in Mumbai, India. A retrospective review of medical records of 11 adolescents enrolled between July 2007 and January 2013 was undertaken. Patients were initiated on either empirical or individualized second-line ambulatory anti-TB treatment under direct observation. The median age was 16 (IQR 14-18) years and 54% were female. Five (46%) adolescents had pulmonary TB (PTB), two (18%) extrapulmonary disease (EPTB) and four (36%) had both. Median CD4 count at the time of MDR-TB diagnosis was 162.7 cells/µl (IQR: 84.8-250.5). By January 2013, eight patients had final and 3 had interim outcomes. Favourable results were seen in four (36.5%) patients: one was cured and three were still on treatment with negative culture results. Seven patients (64%) had poor outcomes: four (36.5%) died and three (27%) defaulted. Three of the patients who died never started on antiretroviral and/or TB treatment and one died 16 days after treatment initiation. Two of the defaulted died soon after default. All patients (100%) on-treatment experienced adverse events (AEs): two required permanent discontinuation of the culprit drug and two were hospitalized due to AEs. No patient required permanent discontinuation of the entire second-line TB or antiretroviral regimens. Early mortality and mortality after default were the most common reasons for poor outcomes in this study. Early mortality suggests the need for rapid diagnosis and prompt treatment initiation, and adolescents might benefit from active contact-tracing and immediate referral. Default occurred at different times, suggesting the need for continuous, intensified and individualized psychosocial support for co-infected adolescents

  5. Clinical Outcomes of 174 Nasopharyngeal Carcinoma Patients With Radiation-Induced Temporal Lobe Necrosis

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

    Lam, Tai-Chung, E-mail: lamtaichung@gmail.com; Wong, Frank C.S.; Leung, To-Wai

    Purpose: To retrospectively study the clinical outcomes of nasopharyngeal carcinoma patients with radiation-induced temporal lobe necrosis (TLN) treated with steroids, surgery, or observation only. Methods and Patients: We performed a retrospective analysis of 174 consecutive patients diagnosed with TLN between 1990 and 2008. Before 1998, symptomatic patients were treated with oral steroids, while asymptomatic patients were treated conservatively. After 1998, most symptomatic and asymptomatic patients with a large volume of necrosis were treated by intravenously pulsed-steroid therapy with a standardized protocol. We examined factors affecting grade 4 complication-free survival and overall survival. Outcomes of the three treatment groups, those receivingmore » conservative treatment, those receiving oral steroid, and those receiving intravenous pulse steroid, were compared. Results: The mean follow-up time was 115 months. Rates of grade 4 complication-free survival at 2 years and at 5 years after diagnosis of TLN were 72.2% and 54.1%, respectively. The 2-year and 5-year overall survival rates were 57.5% and 35.4%, respectively. Multivariate analysis revealed that being symptomatic at diagnosis (relative risk [RR], 4.5; p = 0.0001), re-irradiation of the nasopharynx (NP) (RR, 1.56; p = 0.008), salvage brachytherapy to the NP (RR, 1.75; p = 0.012), and a short latency period before the diagnosis of TLN (RR, 0.96, p < 0.0001) were independent prognosticators of poor grade 4 complication-free survival. Patients with all four factors had a 100% risk of developing grade 4 complications within 5 years; whereas if no factor was present, the risk was 12.5%. Intravenous pulse steroid therapy was associated with a higher clinical response rate compared with conventional steroid therapy (p < 0.0001); however, it did not affect complication-free survival in multivariate analysis. Conclusions: TLN patients with good prognosticators could be observed without active treatment

  6. Stem cell transplantation as a dynamical system: are clinical outcomes deterministic?

    PubMed

    Toor, Amir A; Kobulnicky, Jared D; Salman, Salman; Roberts, Catherine H; Jameson-Lee, Max; Meier, Jeremy; Scalora, Allison; Sheth, Nihar; Koparde, Vishal; Serrano, Myrna; Buck, Gregory A; Clark, William B; McCarty, John M; Chung, Harold M; Manjili, Masoud H; Sabo, Roy T; Neale, Michael C

    2014-01-01

    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.

  7. Stem Cell Transplantation as a Dynamical System: Are Clinical Outcomes Deterministic?

    PubMed Central

    Toor, Amir A.; Kobulnicky, Jared D.; Salman, Salman; Roberts, Catherine H.; Jameson-Lee, Max; Meier, Jeremy; Scalora, Allison; Sheth, Nihar; Koparde, Vishal; Serrano, Myrna; Buck, Gregory A.; Clark, William B.; McCarty, John M.; Chung, Harold M.; Manjili, Masoud H.; Sabo, Roy T.; Neale, Michael C.

    2014-01-01

    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. PMID:25520720

  8. The first pharmacist-managed anticoagulation clinic under a collaborative practice agreement in Qatar: clinical and patient-oriented outcomes.

    PubMed

    Elewa, H F; AbdelSamad, O; Elmubark, A E; Al-Taweel, H M; Mohamed, A; Kheir, N; Mohamed Ibrahim, M I; Awaisu, A

    2016-08-01

    Optimal outpatient anticoagulation management requires a systematic and coordinated approach. Extensive evidence regarding the benefits of pharmacist-managed anticoagulation services has been reported in the literature. The quality and outcomes associated with pharmacist-managed anticoagulation clinics under collaborative practice agreements in the Middle East have rarely been reported. The first pharmacist-managed ambulatory anticoagulation clinic in Qatar was launched at Al-Wakrah Hospital in March 2013. The objectives of this study were to: (i) describe the practice model of the clinic, (ii) evaluate the quality of the clinic [i.e. the time in therapeutic range (TTR)] and the clinical outcomes (i.e. the efficacy and safety), and (iii) determine the patients' satisfaction and overall quality of life (QoL). Clinical outcome data were collected through a retrospective chart review of all patients managed from March 2013 to October 2014 at the pharmacist-managed anticoagulation clinic. Furthermore, the patient-oriented outcomes data were prospectively collected using the 24-item Duke Anticoagulation Satisfaction Scale (DASS). Each item was assessed using a 7-point Likert-type scale on which lower scores indicated better QoL and greater satisfaction. The clinical outcome data analyses included 119 patients who were enrolled at the clinic during the 19-month study period. The mean number of international normalized ratio (INR) tests/month was 65 ± 9, the average testing frequency was 2·7 ± 1·6 weeks, and the average %TTR was 76·8 ± 22·9%. There was one major bleeding event (0·67%/year), 12 minor bleeding events (8%/year) and two thromboembolic events (1·35%/year) recorded during the study period. Of the 119 patients, 50 participated in the satisfaction and QoL survey. The median (IQR) total QoL score of these subjects was 63 (48) (minimum-maximum achievable score: 24-168). Seventy-six per cent of the patients indicated 'a lot to very much' in terms of their

  9. Is cancer history really an exclusion criterion for clinical trial of lung cancer? Influence of gastrointestinal tract cancer history on the outcomes of lung cancer surgery.

    PubMed

    Aokage, Keiju; Okada, Morihito; Suzuki, Kenji; Nomura, Shogo; Suzuki, Shigeki; Tsubokawa, Norifumi; Mimae, Takahiro; Hattori, Aritoshi; Hishida, Tomoyuki; Yoshida, Junji; Tsuboi, Masahiro

    2017-02-15

    Exclusion of patients with a history of other cancer treatment except in situ situation has been considered to be inevitable for clinical trials investigating survival outcome. However, there have been few reports confirming these influences on surgical outcome of lung cancer patients ever. Multi-institutional, individual data from patients with non–small cell lung cancer resected between 2000 and 2013 were collected. The patients were divided into two groups: those with a history of gastrointestinal tract cancer (GI group) and those without any history (non-GI group). We compared the outcomes with well-matched groups using propensity scoring to minimize bias related to the nonrandomness. The influence of gastrointestinal tract cancer stage, disease-free interval, and treatment method for gastrointestinal tract cancer on the surgical outcome of non–small cell lung cancer was examined. We analyzed 196 patients in the GI group and 3732 in the non-GI group. In unmatched cohort, multivariate analyses showed that a history of gastrointestinal tract cancer did not affect overall survival or recurrence-free survival. Independent predictors of poor prognosis included older age, male sex, high carcinoembryonic antigen levels and advanced clinical stage of non–small cell lung cancer. The two groups in the matched cohort demonstrated equivalent overall survival and recurrence-free survival, even in patients with clinical stage I. Gastrointestinal tract cancer stage, disease-free interval and treatment method for gastrointestinal tract cancer were not associated with outcomes. History of early gastrointestinal tract cancer completely resected is not always necessary for exclusion criteria in clinical trial of lung cancer.

  10. A systematic review of clinical outcomes for patients diagnosed with skin cancer spinal metastases.

    PubMed

    Goodwin, C Rory; Sankey, Eric W; Liu, Ann; Elder, Benjamin D; Kosztowski, Thomas; Lo, Sheng-Fu L; Fisher, Charles G; Clarke, Michelle J; Gokaslan, Ziya L; Sciubba, Daniel M

    2016-05-01

    OBJECT Surgical procedures and/or adjuvant therapies are effective modalities for the treatment of symptomatic spinal metastases. However, clinical results specific to the skin cancer spinal metastasis cohort are generally lacking. The purpose of this study was to systematically review the literature for treatments, clinical outcomes, and survival following the diagnosis of a skin cancer spinal metastasis and evaluate prognostic factors in the context of spinal skin cancer metastases stratified by tumor subtype. METHODS The authors performed a literature review using PubMed, Embase, CINAHL, and Web of Science to identify articles since 1950 that reported survival, clinical outcomes, and/or prognostic factors for the skin cancer patient population with spinal metastases. The methodological quality of reviews was assessed using the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) tool. RESULTS Sixty-five studies met the preset criteria and were included in the analysis. Of these studies, a total of 25, 40, 25, and 12 studies included patients who underwent some form of surgery, radiotherapy, chemotherapy, or observation alone, respectively. Sixty-three of the 65 included studies were retrospective in nature (Class of Evidence [CoE] IV), and the 2 prospective studies were CoE II. Based on the studies analyzed, the median overall survival for a patient with a spinal metastasis from a primary skin malignancy is 4.0 months; survival by tumor subtype is 12.5 months for patients with basal cell carcinoma (BCC), 4.0 months for those with melanoma, 4.0 months for those with squamous cell carcinoma, 3.0 months for those with pilomatrix carcinoma, and 1.5 months for those with Merkel cell carcinoma (p < 0.0001). The overall percentage of known continued disease progression after spine metastasis diagnosis was 40.1% (n = 244/608, range 25.0%-88.9%), the rate of known recurrence of the primary skin cancer lesion was 3.5% (n = 21/608, range 0

  11. Analysis of the association of fluid balance and short-term outcome in traumatic brain injury.

    PubMed

    Zhao, Zilong; Wang, Dong; Jia, Ying; Tian, Ye; Wang, Yi; Wei, Yingsheng; Zhang, Jianning; Jiang, Rongcai

    2016-05-15

    A balance of fluid intake and output (fluid balance) influences outcomes of critical illness, but the level of such influence remains poorly understood for traumatic brain injury (TBI) and was quantitatively examined in this study. We conducted a retrospective cohort study of 351 moderate and severe TBI patients to associate the degree of fluid balance with clinical outcomes of TBI. Fluid balance and intracranial pressure (ICP) were continuously recorded for 7days on patients admitted to neurocritical care unit (NCCU). The short-term outcome was dichotomized into improvement and deterioration groups based on changes in Glasgow Coma Scale (GCS) measured between admission and 30days after admission. Fluid balance was calculated as: Fluid intake (mL) - fluid outputs (mL)/day×5 and used to group patients in tertiles to study its effect on TBI outcome. Patients at the low (<637mL) and upper (>3673mL) tertiles of fluid balance were associated with poor outcomes. Those in the upper tertile also had a higher incidence of acute kidney injury (AKI) and refractory intracranial hypertension (RIH). There was a negative correlation between the cumulative fluid balance and the short-term outcome for patients in the low tertile and a positive correlation between the cumulative fluid balance and the short-term outcome in the upper fluid balance group. Levels of fluid balance were also associated with serum creatinine (Cr, r=0.451, P<0.0001) and days in NCCU (r=0.188, P=0.001). More patients in the upper tertile had ICP higher than 20mmHg (P=0.009). A fluid balance in the upper tertile is an independent predictor of poor 30-day clinical outcomes after the adjustment for confounding variables in a multivariable logistic regression model. We found that fluid balance in low and upper tertiles were associated with poor short-term outcomes and ICP variations. Fluid balance in the upper tertile may be an independent predictor for poor 30-day outcome, primarily due to high AKI and RIH

  12. Predicting outcome of acute non-variceal upper gastrointestinal haemorrhage without endoscopy using the clinical Rockall Score.

    PubMed

    Tham, T C K; James, C; Kelly, M

    2006-11-01

    The Rockall risk scoring system uses clinical criteria and endoscopy to identify patients at risk of adverse outcomes after acute upper gastrointestinal haemorrhage. A clinical Rockall score obtained using only the clinical criteria may be able to predict outcome without endoscopy. To validate the clinical Rockall Score in predicting outcome after acute non-variceal upper gastrointestinal haemorrhage. A retrospective observational study of consecutive patients who were admitted with non-variceal acute upper gastrointestinal haemorrhage was undertaken. Medical records were abstracted using a standardised form. 102 cases were identified (51 men and 51 women; mean age 59 years). 38 (37%) patients considered to be at low risk of adverse outcomes (clinical Rockall Score 0) had no adverse outcomes and did not require transfusion. Patients with a clinical Rockall Score of 1-3 had no adverse outcomes, although 13 of 45 (29%) patients required blood transfusions. Clinical Rockall Scores >3 (n = 19) were associated with adverse outcomes (rebleeding in 4 (21%), surgery in 1 (5%) and death in 2 (10%)). The clinical Rockall Score without endoscopy may be a useful prognostic indicator in this cohort of patients with acute non-variceal upper gastrointestinal haemorrhage. This score may reduce the need for urgent endoscopy in low-risk patients, which can instead be carried out on a more elective outpatient basis.

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

    PubMed

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

    2016-05-01

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

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

    PubMed

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

    2012-11-01

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

  15. Management bundles for candidaemia: the impact of compliance on clinical outcomes

    PubMed Central

    Takesue, Yoshio; Ueda, Takashi; Mikamo, Hiroshige; Oda, Shigeto; Takakura, Shunji; Kitagawa, Yuko; Kohno, Shigeru; Masuda, A.; Yoshida, C.; Yasunaga, C.; Yamashita, C.; Nakataki, E.; Ohyagi, H.; Yagi, H.; Johnai, H.; Murai, H.; Hanamoto, H.; Nakamura, I.; Sanada, I.; Tandai, I.; Kuroki, J.; Ogawa, J.; Kawahara, K.; Amino, K.; Nakajima, K.; Yoshimoto, K.; Takeda, K.; Nakamura, K.; Suzuki, K.; Yamada, K.; Aizawa, M.; Hashimoto, M.; Ogata, M.; Shirano, M.; Kawada, M.; Kaneda, M.; Yoshioka, M.; Okuda, N.; Sugita, N.; Kikuchi, N.; Fuke, S.; Tsuchihashi, S.; Sugitani, S.; Ikuta, S.; Honda, S.; Nei, T.; Iwamura, T.; Yagi, T.; Kaji, T.; Ichimiya, Y.; Kobayashi, Y.; Minamishima, Y.; Goto, Y.; Hatano, Y.; Nagao, Y.; Yamagishi, Y.; Sashihara, J.; Tsukamoto, A.; Kawaoka, T.; Kobayashi, M.

    2015-01-01

    Objectives The Mycoses Forum in Japan has developed management bundles for candidaemia to incorporate into bedside practice. The aim of this study was to investigate nationwide compliance with the bundles and their impact on clinical outcomes. Methods Non-neutropenic patients treated with antifungals for candidaemia were surveyed. Bundles consist of nine items to complete. Data were sent to the central office between July 2011 and April 2012. Results Six hundred and eight patients were analysed. The compliance rate for achieving all elements was 6.9%, and it increased to 21.4% when compliance was analysed by the bundle except for oral switch. There was a significant difference in clinical success between patients with and without compliance [92.9% versus 75.8% (P = 0.011)]. Compliance with the bundles, however, failed to be an independent factor associated with favourable outcomes. When step-down oral therapy was excluded from the elements of compliance, compliance with the bundles was revealed to be an independent predictor of clinical success (OR 4.42, 95% CI 2.05–9.52) and mortality (OR 0.27, 95% CI 0.13–0.57). Independent individual elements contributing to clinical success were removal of central venous catheters within 24 h, assessment of clinical efficacy on the third to the fifth day and at least 2 weeks of therapy after clearance of candidaemia. Conclusions Compliance with the bundles for candidaemia had a beneficial effect on clinical outcomes. Promotion of the bundles approach may have the potential to narrow the gap between clinical evidence and bedside practice. PMID:25326087

  16. After laparoscopic Heller myotomy, do emergency department visits or readmissions predict poor long-term outcomes?

    PubMed

    Ross, Sharona; Villadolid, Desiree; Al-Saadi, Sam; Boyle, Robert; Cowgill, Sarah M; Rosemurgy, Alexander

    2008-12-01

    Laparoscopic Heller myotomy is a first-line treatment for achalasia. To improve outcomes after myotomy and to determine if poor early results predict later outcomes, emergency department (ED) visits and readmissions within 60 days following laparoscopic Heller myotomy were studied. Since 1992, 352 patients have undergone laparoscopic Heller myotomy and are followed through a prospectively maintained registry. Causes of ED visits and readmissions within 60 days after myotomy were determined. Patients scored their symptoms of achalasia before myotomy and at last follow-up; scores were compared to determine if the reasons leading to ED visits and/or readmissions impacted long-term outcome after myotomy. Fourteen (4%) patients had ED visits, and 18 (5%) patients had readmissions within 60 days following myotomy. Sixty-four percent of ED visits were for dysphagia/vomiting and 36% were for abdominal/chest pain, while 37% of readmissions were for dysphagia/vomiting. Pneumonia was complicated by empyema in four patients, all without leaks; two patients expired. Despite ED visits/readmissions, achalasia symptom (e.g., dysphagia, regurgitation, choking, heartburn, and chest pain) frequency and severity scores improved after myotomy (p < 0.05 for all). ED visits and readmissions are infrequent following laparoscopic Heller myotomy. ED visits were generally due to complaints related to achalasia or edema after myotomy, while readmissions were generally related to complications of operative intervention or chronic ill health. Despite ED visits or readmissions early after myotomy, symptoms of achalasia are well palliated by myotomy long-term.

  17. Patients with mantle cell lymphoma failing ibrutinib are unlikely to respond to salvage chemotherapy and have poor outcomes.

    PubMed

    Cheah, C Y; Chihara, D; Romaguera, J E; Fowler, N H; Seymour, J F; Hagemeister, F B; Champlin, R E; Wang, M L

    2015-06-01

    Although ibrutinib is highly effective in patients with relapsed/refractory mantle cell lymphoma (MCL), a substantial proportion of patients have resistant disease. The subsequent outcomes of such patients are unknown. We carried out a retrospective review of all patients with MCL treated with ibrutinib at MD Anderson Cancer Center between January 2011 and January 2014 using pharmacy and clinical databases. Patients who had discontinued ibrutinib for any reason were included in the study. We identified 42 patients with MCL who discontinued therapy due to disease progression on treatment (n = 28), toxicity (n = 6), elective stem-cell transplant in remission (n = 4) or withdrawn consent (n = 4). The median age was 69 years, 35 (83%) were male; the median number of prior treatments was 2 (range 1-8) and the median time from initial diagnosis of MCL to commencing ibrutinib was 3.0 (range 0.5-15.5) years. Patients had received a median of 6.5 (range 1-43) cycles of ibrutinib. Among 31 patients who experienced disease progression following ibrutinib and underwent salvage therapy, the overall and complete response rates were 32% and 19%, respectively. After a median follow-up of 10.7 (range 2.4-38.9) months from discontinuation of ibrutinib, the median overall survival (OS) among patients with disease progression was 8.4 months. By univariate analysis, elevated serum lactate dehydrogenase at progression was associated with inferior OS. The outcome of patients with MCL who experience disease progression following ibrutinib therapy is poor, with both low response rates to salvage therapy and short duration of responses. Further studies to better understand and overcome ibrutinib resistance are urgently needed. © The Author 2015. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For permissions, please email: journals.permissions@oup.com.

  18. Implementation of an institutional program to improve clinical and financial outcomes of mechanically ventilated patients: one-year outcomes and lessons learned.

    PubMed

    Burns, Suzanne M; Earven, Sidenia; Fisher, Charles; Lewis, Rose; Merrell, Paul; Schubart, Jane R; Truwit, Jonathon D; Bleck, Thomas P

    2003-12-01

    To determine the effect of an institutional approach to the care of patients requiring mechanical ventilation for longer than three consecutive days in five adult intensive care units (ICU) on clinical and financial outcomes. A multidisciplinary team was selected from five adult ICUs to design the approach. Planning occurred from August 1999 to September 2000. The process was called outcomes management (OM) and included an evidence-based clinical pathway, protocols for weaning and sedation use, and the selection of four advanced practice nurses (called outcomes managers) to manage and monitor the program. The project was completed in a 550-bed mid-Atlantic academic medical center. The ICUs included the following: coronary care, medical ICU, neuroscience ICU, surgical trauma ICU, and thoracic cardiovascular ICU. The sample included 595 pre-OM patients and 510 post-OM patients mechanically ventilated for greater than three consecutive days. Full implementation of the OM approach occurred in March 2001. Retrospective baseline (18 months pre-OM) and prospective (12 months OM) clinical and financial data were compared. Statistically significant differences in clinical outcomes were demonstrated in the managed patients compared with those managed before the institutional approach. Outcomes include ventilator duration (median days declined from ten to nine; p =.0001), ICU length of stay (median days declined from 15 to 12; p =.0008), hospital length of stay (median days declined from 22 to 20; p =.0001), and mortality rate (declined from 38% to 31%, p =.02). More than 3,000,000 US dollars cost savings were realized in the OM group. This institutional approach to the care of patients ventilated >3 days improved all clinical and financial outcomes of interest. To date, few similar initiatives have demonstrated similar results. The approach and lessons learned in this process improvement project may be helpful to other institutions attempting to improve outcomes in this

  19. Brief episodes of intracranial hypertension and cerebral hypoperfusion are associated with poor functional outcome after severe traumatic brain injury.

    PubMed

    Stein, Deborah M; Hu, Peter F; Brenner, Megan; Sheth, Kevin N; Liu, Keng-Hao; Xiong, Wei; Aarabi, Bizhan; Scalea, Thomas M

    2011-08-01

    Management strategies after severe traumatic brain injury (TBI) target prevention and treatment of intracranial hypertension (ICH) and cerebral hypoperfusion (CH). We have previously established that continuous automated recordings of vital signs (VS) are more highly correlated with outcome than manual end-hour recordings. One potential benefit of automated vital sign data capture is the ability to detect brief episodes of ICH and CH. The purpose of this study was to establish whether a relationship exists between brief episodes of ICH and CH and outcome after severe TBI. Patients at the R Adams Cowley Shock Trauma Center were prospectively enrolled over a 2-year period. Inclusion criteria were as follows: age >14 years, admission within the first 6 hours after injury, Glasgow Coma Scale score <9 on admission, and placement of a clinically indicated ICP monitor. From high-resolution automated VS data recording system, we calculated the 5-minute means of intracranial pressure (ICP), cerebral perfusion pressure (CPP), and Brain Trauma Index (BTI = CPP/ICP). Patients were stratified by mortality and 6-month Extended Glasgow Outcome Score (GOSE). Sixty subjects were enrolled with a mean admission Glasgow Coma Scale score of 6.4 ± 3.1, a mean Head Abbreviated Injury Severity Scale score of 4.2 ± 0.7, and a mean Marshall CT score of 2.5 ± 0.9. Significant differences in the mean number of brief episodes of CPP <50 and BTI <2 in patients with a GOSE 1-4 versus GOSE 5-8 (9.4 vs. 4.7, p = 0.02 and 9.3 vs. 4.9, p = 0.03) were found. There were significantly more mean brief episodes per day of ICP >30 (0.52 vs. 0.29, p = 0.02), CPP <50 (0.65 vs. 0.28, p < 0.001), CPP <60 (1.09 vs. 0.7, p = 0.03), BTI <2 (0.66 vs. 0.31, p = 0.002), and BTI <3 (1.1 vs. 0.64, p = 0.01) in those patients with GOSE 1-4. Number of brief episodes of CPP <50, CPP <60, BTI <2, and BTI <3 all demonstrated high predictive power for unfavorable functional outcome (area under the curve = 0.65-0.75, p

  20. Predicting HIV RNA virologic outcome at 52-weeks follow-up in antiretroviral clinical trials. The INCAS and AVANTI Study Groups.

    PubMed

    Raboud, J M; Rae, S; Montaner, J S

    2000-08-15

    To determine the ability of intermediate plasma viral load (pVL) measurements to predict virologic outcome at 52 weeks of follow-up in clinical trials of antiretroviral therapy. Individual patient data from three clinical trials (INCAS, AVANTI-2 and AVANTI-3) were combined into a single database. Virologic success was defined to be plasma viral load (pVL) <500 copies/ml at week 52. The sensitivity and specificity of intermediate pVL measurements below the limit of detection, 100, 500, 1000, and 5000 copies/ml to predict virologic success were calculated. The sensitivity, specificity, and positive and negative predictive values of a pVL measurement <1000 copies/ml at week 16 to predict virologic outcome at week 52 were 74%, 74%, 48%, and 90%, respectively, for patients on double therapy. For patients on triple therapy, the sensitivity, specificity, and positive and negative predictive values of a pVL measurement <50 copies/ml at week 16 to predict virologic outcome were 68%, 68%, 80%, and 47%, respectively. For patients receiving double therapy, a poor virologic result at an intermediate week of follow-up is a strong indicator of virologic failure at 52 weeks whereas intermediate virologic success is no guarantee of success at 1 year. For patients on triple therapy, disappointing intermediate results do not preclude virologic success at 1 year and intermediate successes are more likely to be sustained.