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Sample records for 2-year clinical outcomes

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

    PubMed Central

    Narang, Priya; Agarwal, Amar

    2015-01-01

    Purpose: To demonstrate the safety and outcome of a surgical approach that uses pars plicata site for anterior vitrectomy during phacoemulsification procedure complicated by posterior capsule rupture and residual cortical matter. Design: Single center, retrospective, interventional, noncomparative study. Materials and Methods: Medical records of a consecutive series of 35 eyes of 35 patients who underwent pars plicata anterior vitrectomy (PPAV) were reviewed. The main outcome measures were corrected and uncorrected distance visual acuity (CDVA, UDVA), early and late postoperative complications and intraocular pressure (IOP). Ultrasound biomicroscopic (UBM) evaluation of sclerotomy site and spectral domain optical coherence tomography analysis for central macular thickness (CMT) was performed. The final visual outcome at 2 years was evaluated. Results: At 2 years follow-up, the mean postoperative UDVA (logarithm of the minimum angle of resolution [logMAR]) and CDVA (logMAR) was 0.49 ± 0.26 and 0.19 ± 0.14, respectively. There was no significant change in the IOP (P = 0.061) and the mean CMT at 2 years was 192.5 ± 5.54 μm. The postoperative UBM image of the sclerotomy site at 8 weeks demonstrated a clear wound without any vitreous adhesion or incarceration. Intraoperative hyphema was seen in 1 (2.8%) case and postoperative uveitis was seen in 2 (5.7%) cases, which resolved with medications. No case of an iatrogenic retinal break or retinal detachment was reported. Conclusions: PPAV enables a closed chamber approach, allows thorough cleanup of vitreous in the pupillary plane and anterior chamber and affords better access to the subincisional and retropupillary cortical remnant with a significant visual outcome and an acceptable complication rate. PMID:26632124

  2. Clinical and laboratory 2-year outcome of oral immunotherapy in patients with cow's milk allergy.

    PubMed

    Elizur, A; Appel, M Y; Goldberg, M R; Yichie, T; Levy, M B; Nachshon, L; Katz, Y

    2016-02-01

    Studies examining the long-term effect of oral immunotherapy in food-allergic patients are limited. We investigated cow's milk-allergic patients, >6 months after the completion of oral immunotherapy (n = 197). Questionnaires, skin prick tests, and basophil activation assays were performed. Of the 195 patients contacted, 180 (92.3%) were consuming milk protein regularly. Half experienced adverse reactions, mostly mild. Thirteen patients (6.7%) required injectable epinephrine. Higher reaction rate after immunotherapy was associated with more anaphylactic episodes before treatment and a lower starting dose (OR = 2.1, P = 0.035 and OR = 2.3, P = 0.035, respectively). Reaction rate in patients who were 6-15 months, 15-30 months, or >30 months post-treatment decreased from 0.28/month to 0.21/month to 0.15/month, respectively (P < 0.01). Milk-induced %CD63 and %CD203c expression was significantly lower in patients >24 months vs in patients <24 months post-treatment (P = 0.038 and P = 0.047, respectively). In conclusion, many patients experience mild adverse reactions after completing oral immunotherapy and some require injectable epinephrine. Progressive desensitization, both clinically and in basophil reactivity, occurs over time. PMID:26482941

  3. Clinical Features and Treatment Outcomes of Primary Immune Thrombocytopenic Purpura in Hospitalized Children Under 2-Years Old

    PubMed Central

    Farhangi, H; Ghasemi, A; Banihashem, A; Badiei, Z; Jarahi, L; Eslami, G; Langaee, T

    2016-01-01

    Background Immune thrombocytopenic purpura (ITP) is the most prevalent cause of thrombocytopenia in children. Despite the importance of ITP in children under 2-years old, only a few publications are available in the literature.ITP usually presents itself as isolated thrombocytopenia and mucocutaneous bleeding. Materials and Methods This study was conducted on 187 under 2-year-old children diagnosed with ITP and treated at Dr. Sheikh Hospital from 2004 to 2011.In this retrospective study, clinical symptoms, laboratory findings, history of viral infections, vaccination history, and treatment efficacy in children under 2-years old with ITP were investigated.Patients were followed for one year after being discharged from the hospital. Results The risk of the disease developing into chronic form was higher in older children (0.001). ITP in children under 3-months old was significantly associated with vaccination (p=0.007). There was no significant differences between male and female patients in regards to newly diagnosed ITP, persistent, and chronic disease status (p = 0.21). No significant difference in bleeding symptoms was observed between patients under 3-months old and 3 to 24-months old (p=0.18). Conclusion Infantile ITP respond favorably to treatment. The risk of the disease developing into chronic form is higher in 3-to-24-month-old children compared to under-three-month olds. PMID:27222699

  4. Duration of untreated psychosis predicts functional and clinical outcome in children and adolescents with first-episode psychosis: a 2-year longitudinal study.

    PubMed

    Fraguas, David; Del Rey-Mejías, Angel; Moreno, Carmen; Castro-Fornieles, Josefina; Graell, Montserrat; Otero, Soraya; Gonzalez-Pinto, Ana; Moreno, Dolores; Baeza, Inmaculada; Martínez-Cengotitabengoa, Mónica; Arango, Celso; Parellada, Mara

    2014-01-01

    Longer duration of untreated psychosis (DUP) in adult patients with first-episode psychosis (FEP) has been associated with poor clinical and social outcomes. We aimed to estimate the influence of DUP on outcome at 2-year follow-up in subjects with an early-onset (less than 18 years of age) FEP of less than 6 months' duration. A total of 80 subjects (31.3% females, mean age 16.0±1.8 years) were enrolled in the study. The influence of DUP on outcome was estimated using multiple regression models (two linear models for influence of DUP on the C-GAF at 2 years and C-GAF change through the follow-up period, and a logistic model for influence of DUP on 41 PANSS remission at 2 years in schizophrenia patients (n=47)). Mean DUP was 65.3±54.7 days. Median DUP was 49.5 days. For the whole sample (n=80), DUP was the only variable significantly related to C-GAF score at 2-year follow-up (Beta=-0.13, p<0.01), while DUP and premorbid adjustment (Beta=-0.01, p<0.01; and Beta=-0.09, p=0.04, respectively) were the only variables significantly related to C-GAF change. In schizophrenia patients, DUP predicted both C-GAF score at 2 years and C-GAF change, while in patients with affective psychosis (n=22), DUP was unrelated to outcome. Lower baseline C-GAF score (OR=0.91, p<0.01) and shorter DUP (OR=0.98, p=<0.01) were the only variables that significantly predicted clinical remission in schizophrenia patients. In conclusion, longer DUP was associated with lower C-GAF at 2 years, less increase in C-GAF, and lower rates of clinical remission in early-onset FEP. Our findings support the importance of early detection programs, which help shorten DUP. PMID:24332406

  5. Neonatal Glycemia and Neurodevelopmental Outcomes at 2 Years

    PubMed Central

    McKinlay, Christopher J.D.; Alsweiler, Jane M.; Ansell, Judith M.; Anstice, Nicola S.; Chase, J. Geoffrey; Gamble, Gregory D.; Harris, Deborah L.; Jacobs, Robert J.; Jiang, Yannan; Paudel, Nabin; Signal, Matthew; Thompson, Benjamin; Wouldes, Trecia A.; Yu, Tzu-Ying; Harding, Jane E.

    2015-01-01

    Background Neonatal hypoglycemia is common and can cause neurologic impairment, but evidence supporting thresholds for intervention is limited. Methods We performed a prospective cohort study involving 528 neonates with a gestational age of at least 35 weeks who were considered to be at risk for hypoglycemia; all were treated to maintain a blood glucose concentration of at least 47 mg per deciliter (2.6 mmol per liter). We intermittently measured blood glucose for up to 7 days. We continuously monitored interstitial glucose concentrations, which were masked to clinical staff. Assessment at 2 years included Bayley Scales of Infant Development III and tests of executive and visual function. Results Of 614 children, 528 were eligible, and 404 (77% of eligible children) were assessed; 216 children (53%) had neonatal hypoglycemia (blood glucose concentration, <47 mg per deciliter). Hypoglycemia, when treated to maintain a blood glucose concentration of at least 47 mg per deciliter, was not associated with an increased risk of the primary outcomes of neurosensory impairment (risk ratio, 0.95; 95% confidence interval [CI], 0.75 to 1.20; P = 0.67) and processing difficulty, defined as an executive-function score or motion coherence threshold that was more than 1.5 SD from the mean (risk ratio, 0.92; 95% CI, 0.56 to 1.51; P = 0.74). Risks were not increased among children with unrecognized hypoglycemia (a low interstitial glucose concentration only). The lowest blood glucose concentration, number of hypoglycemic episodes and events, and negative interstitial increment (area above the interstitial glucose concentration curve and below 47 mg per deciliter) also did not predict the outcome. Conclusions In this cohort, neonatal hypoglycemia was not associated with an adverse neurologic outcome when treatment was provided to maintain a blood glucose concentration of at least 47 mg per deciliter. (Funded by the Eunice Kennedy Shriver National Institute of Child Health and Human

  6. Cervical Stand-Alone Polyetheretherketone Cage versus Zero-Profile Anchored Spacer in Single-Level Anterior Cervical Discectomy and Fusion : Minimum 2-Year Assessment of Radiographic and Clinical Outcome

    PubMed Central

    Cho, Hyun-Jun; Hur, Junseok W.; Han, Jin-Sol; Cho, Tai-Hyoung; Park, Jung-Yul

    2015-01-01

    Objective We compared the clinical and radiographic outcomes of stand-alone polyetheretherketone (PEEK) cage and Zero-Profile anchored spacer (Zero-P) for single level anterior cervical discectomy and fusion (ACDF). Methods We retrospectively reviewed 121 patients who underwent single level ACDF within 2 years (Jan 2011-Jan 2013) in a single institute. Total 50 patients were included for the analysis who were evaluated more than 2-year follow-up. Twenty-nine patients were allocated to the cage group (m : f=19 : 10) and 21 for Zero-P group (m : f=12 : 9). Clinical (neck disability index, visual analogue scale arm and neck) and radiographic (Cobb angle-segmental and global cervical, disc height, vertebral height) assessments were followed at pre-operative, immediate post-operative, post-3, 6, 12, and 24 month periods. Results Demographic features and the clinical outcome showed no difference between two groups. The change between final follow-up (24 months) and immediate post-op of Cobb-segmental angle (p=0.027), disc height (p=0.002), vertebral body height (p=0.033) showed statistically better outcome for the Zero-P group than the cage group, respectively. Conclusion The Zero-Profile anchored spacer has some advantage after cage for maintaining segmental lordosis and lowering subsidence rate after single level anterior cervical discectomy and fusion. PMID:26361527

  7. Cytokines as a predictor of clinical response following hip arthroscopy: minimum 2-year follow-up.

    PubMed

    Shapiro, Lauren M; Safran, Marc R; Maloney, William J; Goodman, Stuart B; Huddleston, James I; Bellino, Michael J; Scuderi, Gaetano J; Abrams, Geoffrey D

    2016-08-01

    Hip arthroscopy in patients with osteoarthritis has been shown to have suboptimal outcomes. Elevated cytokine concentrations in hip synovial fluid have previously been shown to be associated with cartilage pathology. The purpose of this study was to determine whether a relationship exists between hip synovial fluid cytokine concentration and clinical outcomes at a minimum of 2 years following hip arthroscopy. Seventeen patients without radiographic evidence of osteoarthritis had synovial fluid aspirated at time of portal establishment during hip arthroscopy. Analytes included fibronectin-aggrecan complex as well as a multiplex cytokine array. Patients completed the modified Harris Hip Score, Western Ontario and McMaster Universities Arthritis Index and the International Hip Outcomes Tool pre-operatively and at a minimum of 2 years following surgery. Pre and post-operative scores were compared with a paired t-test, and the association between cytokine values and clinical outcome scores was performed with Pearson's correlation coefficient with an alpha value of 0.05 set as significant. Sixteen of seventeen patients completed 2-year follow-up questionnaires (94%). There was a significant increase in pre-operative to post-operative score for each clinical outcome measure. No statistically significant correlation was seen between any of the intra-operative cytokine values and either the 2-year follow-up scores or the change from pre-operative to final follow-up outcome values. No statistically significant associations were seen between hip synovial fluid cytokine concentrations and 2-year follow-up clinical outcome assessment scores for those undergoing hip arthroscopy. PMID:27583163

  8. Cytokines as a predictor of clinical response following hip arthroscopy: minimum 2-year follow-up

    PubMed Central

    Shapiro, Lauren M.; Safran, Marc R.; Maloney, William J.; Goodman, Stuart B.; Huddleston, James I.; Bellino, Michael J.; Scuderi, Gaetano J.; Abrams, Geoffrey D.

    2016-01-01

    Hip arthroscopy in patients with osteoarthritis has been shown to have suboptimal outcomes. Elevated cytokine concentrations in hip synovial fluid have previously been shown to be associated with cartilage pathology. The purpose of this study was to determine whether a relationship exists between hip synovial fluid cytokine concentration and clinical outcomes at a minimum of 2 years following hip arthroscopy. Seventeen patients without radiographic evidence of osteoarthritis had synovial fluid aspirated at time of portal establishment during hip arthroscopy. Analytes included fibronectin–aggrecan complex as well as a multiplex cytokine array. Patients completed the modified Harris Hip Score, Western Ontario and McMaster Universities Arthritis Index and the International Hip Outcomes Tool pre-operatively and at a minimum of 2 years following surgery. Pre and post-operative scores were compared with a paired t-test, and the association between cytokine values and clinical outcome scores was performed with Pearson’s correlation coefficient with an alpha value of 0.05 set as significant. Sixteen of seventeen patients completed 2-year follow-up questionnaires (94%). There was a significant increase in pre-operative to post-operative score for each clinical outcome measure. No statistically significant correlation was seen between any of the intra-operative cytokine values and either the 2-year follow-up scores or the change from pre-operative to final follow-up outcome values. No statistically significant associations were seen between hip synovial fluid cytokine concentrations and 2-year follow-up clinical outcome assessment scores for those undergoing hip arthroscopy. PMID:27583163

  9. 2-year outcomes in Initial survivors with Acute Liver failure: Results from a Prospective, Multicenter Study

    PubMed Central

    Fontana, Robert J.; Ellerbe, Caitlyn; Durkalski, Valerie E.; Rangnekar, Amol; Reddy, K. Rajender; Stravitz, Todd; McGuire, Brendan; Davern, Timothy; Reuben, Adrian; Liou, Iris; Fix, Oren; Ganger, Daniel R; Chung, Raymond T.; Schilsky, Mike; Han, Steven; Hynan, Linda S.; Sanders, Corron; Lee, William M.

    2014-01-01

    BACKGROUND The long-term clinical outcomes in initial survivors with acute liver failure (ALF) are not well known. AIMS The aim of the current study is to provide an overview of the 2 year clinical outcomes amongst initial survivors and liver transplant (LT) recipients that were alive 3 weeks after enrollment in the Acute Liver Failure Study Group (ALFSG). METHODS Outcomes in adult ALFSG patients that were enrolled between 1998 and 2010 were reviewed. RESULTS 2-year patient survival was significantly higher in the 262 LT recipients (92.4%) compared to the 306 acetaminophen (APAP) spontaneous survivors (SS) (89.5%) and 200 non-APAP SS (75.5%) (p < 0.0001). The causes of death were similar in the 3 groups but the time to death was significantly longer in the LT recipients (p< 0.0001). Independent predictors of 2-year mortality in the APAP group were a high serum phosphate level and patient age (c-statistic = 0.65 (0.54, 0.76)), patient age and days from jaundice to ALF onset in the non-APAP group (c-statistic =0.69 (0.60, 0.78)), and patient age, days from jaundice, and higher coma grade in the LT recipients (c-statistic=0.74 (0.61, 0.87)). The LT recipients were significantly more likely to be employed and have a higher educational level (p < 0.05). CONCLUSIONS Two-year outcomes in initial survivors of ALF are generally good but non-APAP patients have a significantly lower survival which may relate to pre-existing medical co-morbidities. Spontaneous survivors with APAP overdose experience substantial morbidity during follow-up from ongoing psychiatric and substance abuse issues. PMID:25039930

  10. Clinical neuroprediction: Amygdala reactivity predicts depressive symptoms 2 years later.

    PubMed

    Mattson, Whitney I; Hyde, Luke W; Shaw, Daniel S; Forbes, Erika E; Monk, Christopher S

    2016-06-01

    Depression is linked to increased amygdala activation to neutral and negatively valenced facial expressions. Amygdala activation may be predictive of changes in depressive symptoms over time. However, most studies in this area have focused on small, predominantly female and homogenous clinical samples. Studies are needed to examine how amygdala reactivity relates to the course of depressive symptoms dimensionally, prospectively and in populations diverse in gender, race and socioeconomic status. A total of 156 men from predominately low-income backgrounds completed an fMRI task where they viewed emotional facial expressions. Left and right amygdala reactivity to neutral, but not angry or fearful, facial expressions relative to a non-face baseline at age 20 predicted greater depressive symptoms 2 years later, controlling for age 20 depressive symptoms. Heightened bilateral amygdala reactivity to neutral facial expressions predicted increases in depressive symptoms 2 years later in a large community sample. Neutral facial expressions are affectively ambiguous and a tendency to interpret these stimuli negatively may reflect to cognitive biases that lead to increases in depressive symptoms over time. Individual differences in amygdala reactivity to neutral facial expressions appear to identify those at most risk for a more problematic course of depressive symptoms across time. PMID:26865423

  11. The improving outcomes in intermittent exotropia study: outcomes at 2 years after diagnosis in an observational cohort

    PubMed Central

    2012-01-01

    Background The purpose of this study was to investigate current patterns of management and outcomes of intermittent distance exotropia [X(T)] in the UK. Methods This was an observational cohort study which recruited 460 children aged < 12 years with previously untreated X(T). Eligible subjects were enrolled from 26 UK hospital ophthalmology clinics between May 2005 and December 2006. Over a 2-year period of follow-up, clinical data were prospectively recorded at standard intervals from enrolment. Data collected included angle, near stereoacuity, visual acuity, control of X(T) measured with the Newcastle Control Score (NCS), and treatment. The main outcome measures were change in clinical outcomes (angle, stereoacuity, visual acuity and NCS) in treated and untreated X(T), 2 years from enrolment (or, where applicable, 6 months after surgery). Change over time was tested using the chi-square test for categorical, Wilcoxon test for non-parametric and paired-samples t-test for parametric data. Results At follow-up, data were available for 371 children (81% of the original cohort). Of these: 53% (195) had no treatment; 17% (63) had treatment for reduced visual acuity only (pure refractive error and amblyopia); 13% (50) had non surgical treatment for control (spectacle lenses, occlusion, prisms, exercises) and 17% (63) had surgery. Only 0.5% (2/371) children developed constant exotropia. The surgically treated group was the only group with clinically significant improvements in angle or NCS. However, 8% (5) of those treated surgically required second procedures for overcorrection within 6 months of the initial procedure and at 6-month follow-up 21% (13) were overcorrected. Conclusions Many children in the UK with X(T) receive active monitoring only. Deterioration to constant exotropia, with or without treatment, is rare. Surgery appears effective in improving angle of X(T) and NCS, but rates of overcorrection are high. PMID:22257496

  12. Patient factors predict functional outcomes after cruciate retaining TKA: a 2-year follow-up analysis.

    PubMed

    Roth, Justin S; Buehler, Knute C; Shen, Jianhua; Naughton, Marybeth

    2013-09-01

    We analyzed preoperative patient characteristics and postoperative functional outcomes to identify the most predictive preoperative characteristics of postoperative functional outcome for Cruciate Retaining (CR) TKA. In a prospective, multicenter study, 307 knees with minimum 2-year follow-up were first divided into groups based on 2-year functional performance. Logistic regression then determined SF-36 General Health Score (GHS) to be the most predictive preoperative patient characteristic. Subsequently, a second analysis was performed using preoperative SF-36 GHS to stratify patients into groups. Statistical significance was achieved in both analyses by gender, BMI and hypertension. Statistical significance was achieved in a single analysis by age, preoperative narcotic use, preoperative metabolic medication usage, preoperative pulmonary disease and preoperative use of medication for anxiety or depression. PMID:23523205

  13. The predictive value of 2-year posttreatment biopsy after prostate cancer radiotherapy for eventual biochemical outcome

    SciTech Connect

    Vance, Waseet; Tucker, Susan L.; Crevoisier, Renaud de; Kuban, Deborah A.; Cheung, M. Rex . E-mail: mrcheung@mdanderson.org

    2007-03-01

    Purpose: To determine the value of a 2-year post-radiotherapy (RT) prostate biopsy for predicting eventual biochemical failure in patients who were treated for localized prostate cancer. Methods and Materials: This study comprised 164 patients who underwent a planned 2-year post-RT prostate biopsy. The independent prognostic value of the biopsy results for forecasting eventual biochemical outcome and overall survival was tested with other factors (the Gleason score, 1992 American Joint Committee on Cancer tumor stage, pretreatment prostate-specific antigen level, risk group, and RT dose) in a multivariate analysis. The current nadir + 2 (CN + 2) definition of biochemical failure was used. Patients with rising prostate-specific antigen (PSA) or suspicious digital rectal examination before the biopsy were excluded. Results: The biopsy results were normal in 78 patients, scant atypical and malignant cells in 30, carcinoma with treatment effect in 43, and carcinoma without treatment effect in 13. Using the CN + 2 definition, we found a significant association between biopsy results and eventual biochemical failure. We also found that the biopsy status provides predictive information independent of the PSA status at the time of biopsy. Conclusion: A 2-year post-RT prostate biopsy may be useful for forecasting CN + 2 biochemical failure. Posttreatment prostate biopsy may be useful for identifying patients for aggressive salvage therapy.

  14. Preschoolers with Autism Spectrum Disorder Followed for 2 Years: Those Who Gained and Those Who Lost the Most in Terms of Adaptive Functioning Outcome.

    PubMed

    Hedvall, Åsa; Westerlund, Joakim; Fernell, Elisabeth; Norrelgen, Fritjof; Kjellmer, Liselotte; Olsson, Martina Barnevik; Carlsson, Lotta Höglund; Eriksson, Mats A; Billstedt, Eva; Gillberg, Christopher

    2015-11-01

    Clinical predictors of 2-year outcome in preschoolers with ASD were studied in a population-based group of very young children with ASD (n = 208). Children who gained the most (n = 30) and lost the most (n = 23), i.e., increased or decreased their adaptive functioning outcome according to the Vineland Composite Score between study entry (T1) and follow-up (T2), 2 years later were compared. Individual factors that differed significantly between the two outcome groups were cognitive level, age at referral, not passing expected milestones at 18 months, autistic type behavior problems and regression. However, logistic regression analysis showed that only cognitive level at T1 (dichotomized into IQ < 70 and IQ ≥ 70) made a unique statistically significant contribution to outcome prediction (p = <.001) with an odds ratio of 18.01. The findings have significant clinical implications in terms of information at diagnosis regarding clinical prognosis in ASD. PMID:26123008

  15. Functional outcomes of proximal row carpectomy: 2-year follow-up

    PubMed Central

    Mandarano-Filho, Luiz Garcia; Campioto, Débora Schalge; Bezuti, Márcio Takey; Mazzer, Nilton; Barbieri, Cláudio Henrique

    2015-01-01

    ABSTRACT OBJECTIVE : To evaluate functional outcomes of patients submit-ted to proximal row carpectomy for the treatment of wrist arthri-tis METHODS : This is a retrospective study using wrist motion and grip strenght of patients diagnosed with Kienböck disease and scaphoid non-union surgically treated by this technique RESULTS : Eleven patients with 2-year follow-up were evaluated. Wrist motion (flexion, extension and ulnar deviation) and grip strength were significantly better from preoperative values. Ho-wever, no difference in radial deviation was observed in these patients CONCLUSION : Proximal row carpectomy provides an alternative option for treatment of wrist arthritis, resulting in better active range of motion and grip strength in the long run. Level of Evidence IV, Case Series. PMID:27057144

  16. Minimum 2-Year Outcomes after Resection Arthroplasty of the Sternoclavicular Joint

    PubMed Central

    Katthagen, Jan Christoph; Tahal, Dimitri S.; Menge, Travis; Horan, Marilee P.; Millett, Peter J.

    2016-01-01

    Objectives: Injuries of the sternoclavicular (SC) joint are rare and are usually caused by high energy mechanisms, such as collision sports or motor vehicle accidents. The aims of this study were to assess functional outcomes and return to sport following resection arthroplasty for osteoarthritis of the sternoclavicular joint. Methods: 20 SC joints (18 patients) had undergone resection arthroplasty of up to a maximum of 10 mm of the medial end of the clavicle for painful osteoarthritis, without instability, between November 2006 and November 2013. Patients at least two years out from surgery and living in the U.S. were included in the study. This was an IRB-approved retrospective outcomes study with prospectively collected data. Preoperative and postoperative function and pain levels were assessed with the ASES, SF-12 PCS, QuickDASH and SANE scores. Additionally, the level of sport intensity and the pain levels during activities of daily living, work and recreation were assessed pre- and postoperatively. The results of the functional outcome scores were normally distributed and were compared with the paired sample t-test. The results of pain level assessment were not normally distributed and were compared with the paired Wilcoxon signed-rank test. Results: 19 SC joints in 17 patients (9 female, 8 male; mean age at time of surgery 39.5±17.1 years) met inclusion criteria. One patient refused participation in the study. Two patients (10.5%) were considered failures as they required additional SC joint surgery (one patient with revision resection of the medial clavicle for persistent symptoms and one patient with secondary figure-of-eight graft stabilization for instability). Minimum 2-year outcomes data were available for 14 of the remaining 16 SC joints (88%). The mean time to follow-up was 3.1 years (range, 2.0-8.8 years). The ASES score, QuickDASH, and pain levels demonstrated significant improvement postoperatively (p<0.05; Table 1). No significant differences

  17. Brain Responses to Words in 2-Year-Olds with Autism Predict Developmental Outcomes at Age 6

    PubMed Central

    Kuhl, Patricia K.; Coffey-Corina, Sharon; Padden, Denise; Munson, Jeffrey; Estes, Annette; Dawson, Geraldine

    2013-01-01

    Autism Spectrum Disorder (ASD) is a developmental disability that affects social behavior and language acquisition. ASD exhibits great variability in outcomes, with some individuals remaining nonverbal and others exhibiting average or above average function. Cognitive ability contributes to heterogeneity in autism and serves as a modest predictor of later function. We show that a brain measure (event-related potentials, ERPs) of word processing in children with ASD, assessed at the age of 2 years (N = 24), is a broad and robust predictor of receptive language, cognitive ability, and adaptive behavior at ages 4 and 6 years, regardless of the form of intensive clinical treatment during the intervening years. The predictive strength of this brain measure increases over time, and exceeds the predictive strength of a measure of cognitive ability, used here for comparison. These findings have theoretical implications and may eventually lead to neural measures that allow early prediction of developmental outcomes as well as more individually tailored clinical interventions, with the potential for greater effectiveness in treating children with ASD. PMID:23734230

  18. FORGE Canada Consortium: outcomes of a 2-year national rare-disease gene-discovery project.

    PubMed

    Beaulieu, Chandree L; Majewski, Jacek; Schwartzentruber, Jeremy; Samuels, Mark E; Fernandez, Bridget A; Bernier, Francois P; Brudno, Michael; Knoppers, Bartha; Marcadier, Janet; Dyment, David; Adam, Shelin; Bulman, Dennis E; Jones, Steve J M; Avard, Denise; Nguyen, Minh Thu; Rousseau, Francois; Marshall, Christian; Wintle, Richard F; Shen, Yaoqing; Scherer, Stephen W; Friedman, Jan M; Michaud, Jacques L; Boycott, Kym M

    2014-06-01

    Inherited monogenic disease has an enormous impact on the well-being of children and their families. Over half of the children living with one of these conditions are without a molecular diagnosis because of the rarity of the disease, the marked clinical heterogeneity, and the reality that there are thousands of rare diseases for which causative mutations have yet to be identified. It is in this context that in 2010 a Canadian consortium was formed to rapidly identify mutations causing a wide spectrum of pediatric-onset rare diseases by using whole-exome sequencing. The FORGE (Finding of Rare Disease Genes) Canada Consortium brought together clinicians and scientists from 21 genetics centers and three science and technology innovation centers from across Canada. From nation-wide requests for proposals, 264 disorders were selected for study from the 371 submitted; disease-causing variants (including in 67 genes not previously associated with human disease; 41 of these have been genetically or functionally validated, and 26 are currently under study) were identified for 146 disorders over a 2-year period. Here, we present our experience with four strategies employed for gene discovery and discuss FORGE's impact in a number of realms, from clinical diagnostics to the broadening of the phenotypic spectrum of many diseases to the biological insight gained into both disease states and normal human development. Lastly, on the basis of this experience, we discuss the way forward for rare-disease genetic discovery both in Canada and internationally. PMID:24906018

  19. Stability and Change among High-Functioning Children with Pervasive Developmental Disorders: A 2-Year Outcome Study.

    ERIC Educational Resources Information Center

    Starr, Elizabeth; Szatmari, Peter; Bryson, Susan; Zwaigenbaum, Lonnie

    2003-01-01

    This study compared the 2-year outcomes of 68 children diagnosed with autism or Asperger syndrome at age 6-8 years in terms of symptoms from the Autism Diagnostic Interview. Significant differences were seen in the domains of social interaction, communication, and repetitive activities, with the Asperger group demonstrating fewer and/or less…

  20. Outcomes of a New Residential Scheme for Adults with Intellectual Disabilities in Taiwan: A 2-Year Follow-Up

    ERIC Educational Resources Information Center

    Chou, Y-C.; Pu, C.; Kroger, T.; Lee, W.; Chang, S.

    2011-01-01

    Background: The Taiwanese government launched a new programme in November 2004 to support adults with intellectual disabilities living in smaller facilities. This paper aims to evaluate the service outcomes of this new residential scheme over 2 years including those residents who moved from an institution and those who moved from their family.…

  1. Couple and Individual Adjustment for 2 Years Following a Randomized Clinical Trial Comparing Traditional versus Integrative Behavioral Couple Therapy

    ERIC Educational Resources Information Center

    Christensen, Andrew; Atkins, David C.; Yi, Jean; Baucom, Donald H.; George, William H.

    2006-01-01

    Follow-up data across 2 years were obtained on 130 of 134 couples who were originally part of a randomized clinical trial comparing traditional versus integrative behavioral couple therapy (TBCT vs. IBCT; A. Christensen et al., 2004). Both treatments produced similar levels of clinically significant improvement at 2 years posttreatment (69% of…

  2. Comparison of wear and clinical performance between amalgam, composite and open sandwich restorations: 2-year results.

    PubMed

    Sachdeo, A; Gray, Gordon B; Sulieman, M A; Jagger, Daryll C

    2004-03-01

    There has been some disquiet over the use of mercury containing restorative materials. The most commonly used alternative is composite resin but this has the potential disadvantage associated with wear and marginal leakage, which in turn, has proven to result in secondary caries and sensitivity. To overcome the shortcomings of a directly placed composite restoration, the glass-ionomer/composite open sandwich technique was introduced followed by the subsequent introduction of compomer systems. The aims of this study were to evaluate the wear and clinical performance of a control group of amalgam restorations compared with that of a group of posterior composite resin restorations fillings and a group of compomer/composite open sandwich restorations placed by a single general dental practitioner. The duration of the study was 2 years. One hundred and thirty three (71.4%) patients were successfully recalled and the wear and clinical performance of each restoration after 6, 12 and 24 months was measured, indirectly. There was no statistically significant difference recorded between the groups at 6 months or 1 year (p > 0.05). However, at the end of the 2-year study, there was a significantly lower rate of wear recorded for the control amalgam restorations compared with other two groups (p = 0.033). There was no statistically significant difference in wear recorded between the two groups of tooth-coloured restorations (p > 0.05). With regards to clinical performance of the restorations, occlusal and proximal contacts in each group of restoration remained satisfactory throughout the study. PMID:15058177

  3. Femoro Patella Vialla patellofemoral arthroplasty: An independent assessment of outcomes at minimum 2-year follow-up

    PubMed Central

    Halai, Mansur; Ker, Andrew; Anthony, Iain; Holt, Graeme; Jones, Bryn; Blyth, Mark

    2016-01-01

    AIM To determine outcomes using the Femoro-Patella Vialla (FPV) arthroplasty and if there is an ideal patient for this implant. METHODS A total of 41 FPV patellofemoral joint replacements were performed in 31 patients (22 females, 9 males, mean age 65 years). Mean follow-up was 3.2 years (minimum 2 years). Radiographs were reviewed preoperatively and postoperatively. We assessed whether gender, age, previous surgery, patella atla or trochlear dysplasia influenced patient satisfaction or patient functional outcome. RESULTS The median Oxford Knee Score was 40 and the median Melbourne Patellofemoral Score was 21 postoperatively. Seventy-six percent of patients were satisfied, 10% unsure and 14% dissatisfied postoperatively. There was no radiological progression of tibiofemoral joint arthritis, using the Ahlback grading, in any patient. One patient, who was diagnosed with rheumatoid arthritis postoperatively, underwent revision to total knee replacement. There were no intraoperative lateral releases and no implant failures. Gender, age, the presence of trochlear dysplasia, patella alta or bilateral surgery did not influence patient outcome. Previous surgery did not correlate with outcome. CONCLUSION In contrast to the current literature, the FPV shows promising early results. However, we cannot identify a subgroup of patients with superior outcomes.

  4. Intermediate clinical and radiological results of cervical TDR (Mobi-C®) with up to 2 years of follow-up

    PubMed Central

    Beaurain, J.; Bernard, P.; Dufour, T.; Fuentes, J. M.; Hovorka, I.; Huppert, J.; Steib, J. P.; Vital, J. M.; Aubourg, L.

    2009-01-01

    The interest in cervical total disc replacement (TDR) as an alternative to the so-far gold standard in the surgical treatment of degenerative disc disease (DDD), e.g anterior cervical discectomy and fusion (ACDF), is growing very rapidly. Many authors have established the fact that ACDF may result in progressive degeneration in adjacent segments. On the contrary, but still theoretically, preservation of motion with TDR at the surgically treated level may potentially reduce the occurrence of adjacent-level degeneration (ALD). The authors report the intermediate results of an undergoing multicentre prospective study of TDR with Mobi-C® prosthesis. The aim of the study was to assess the safety and efficacy of the device in the treatment of DDD and secondary to evaluate the radiological status of adjacent levels and the occurrence of ossifications, at 2-year follow-up (FU). 76 patients have performed their 2-year FU visit and have been analyzed clinically and radiologically. Clinical outcomes (NDI, VAS, SF-36) and ROM measurements were analyzed pre-operatively and at the different post-operative time-points. Complications and re-operations were also assessed. Occurrences of heterotopic ossifications (HOs) and of adjacent disc degeneration radiographic changes have been analyzed from 2-year FU X-rays. The mean NDI and VAS scores for arm and neck are reduced significantly at each post-operative time-point compared to pre-operative condition. Motion is preserved over the time at index levels (mean ROM = 9° at 2 years) and 85.5% of the segments are mobile at 2 years. HOs are responsible for the fusion of 6/76 levels at 2 years. However, presence of HO does not alter the clinical outcomes. The occurrence rate of radiological signs of ALD is very low at 2 years (9.1%). There has been no subsidence, no expulsion and no sub-luxation of the implant. Finally, after 2 years, 91% of the patients assume that they would undergo the procedure again. These intermediate

  5. A randomised trial of granulocyte-macrophage colony-stimulating factor for neonatal sepsis: outcomes at 2 years

    PubMed Central

    Marlow, Neil; Morris, Timothy; Brocklehurst, Peter; Carr, Robert; Cowan, Frances M; Patel, Nishma; Petrou, Stavros; Redshaw, Maggie E; Modi, Neena; Dore, Caroline

    2013-01-01

    Objective The authors performed a randomised trial in very preterm small-for-gestational age (SGA) babies to determine if prophylaxis with granulocyte-macrophage colony-stimulating factor (GM-CSF) improves outcomes (the PROGRAMS trial). Despite increased neutrophil counts following GM-CSF, the authors reported no significant difference in neonatal sepsis-free survival. Patients and methods 280 babies born <31 weeks of gestation and SGA were entered into the trial. Outcome was determined at 2 years to determine neurodevelopmental and general health outcomes, including economic costs. Results The authors found no significant differences in health outcomes or health and social care costs between the trial groups. In the GM-CSF arm, 87 of 134 (65%) babies survived to 2 years without severe disability compared with 87 of 131 (66%) controls (RR: 1·0, 95% CI 0·8 to 1·2). Marginally, more children receiving GM-CSF were reported to have cough (RR 1·7, 95% CI 1·1 to 2·6) and had signs of chronic respiratory disease (Harrison's sulcus; RR 2·0, 95% CI 1·0 to 3·9) though this was not reflected in bronchodilator use or need for hospitalisation for respiratory disease. Overall, the rate of neurologic abnormality (7%–9%) was similar but mean overall developmental scores were lower than expected for gestational age. Conclusions The administration of GM-CSF to very preterm SGA babies is not associated with improved or more adverse outcomes at 2 years of age. The apparent excess of developmental impairment in the entire PROGRAMS cohort, without corresponding increase in neurological abnormality, may represent diffuse brain injury attributable to intrauterine growth restriction. PMID:22542709

  6. Occlusal glass ionomer cermet, resin sandwich and amalgam restorations: a 2-year clinical study.

    PubMed

    Lidums, A; Wilkie, R; Smales, R

    1993-08-01

    This study compared the clinical behavior of a glass ionomer silver cermet (Ketac-Silver), a posterior resin composite (Visio-Molar) used with the "sandwich" technique, and a high-copper amalgam (Dispersalloy) for restoring conventional Class I occlusal cavity preparations. Two dentists placed 116 restorations in the posterior permanent teeth of 35 adults treated at a dental hospital. Restorations were assessed at 6-month intervals over 2 years for bulk loss of material and occlusal wear, surface voids, roughness and cracking, surface and marginal staining, and marginal fracture. Losses of material and surface voids were obvious with the cermet material, with surface crazing or cracking being present in 33% of the restorations. The cermet cannot be recommended as a long-term permanent restorative material if the restorations are likely to be subjected to heavy occlusal stresses and abrasive wear. PMID:7803005

  7. Long-Term Outcomes of a Web-Based Diabetes Prevention Program: 2-Year Results of a Single-Arm Longitudinal Study

    PubMed Central

    Jiang, Luohua; Peters, Anne L

    2015-01-01

    Background Digital therapeutics are evidence-based behavioral treatments delivered online that can increase accessibility and effectiveness of health care. However, few studies have examined long-term clinical outcomes of digital therapeutics. Objective The objective of this study was to conduct a 2-year follow-up on participants in the Internet-based Prevent diabetes prevention program pilot study, specifically examining the effects on body weight and A1c, which are risk factors for diabetes development. Methods A quasi-experimental research design was used, including a single-arm pre- and post-intervention assessment of outcomes. Participants underwent a 16-week weight loss intervention and an ongoing weight maintenance intervention. As part of the program, participants received a wireless scale, which was used to collect body weight data on an ongoing basis. Participants also received A1c test kits at baseline, 0.5 year, 1 year, and 2-year time points. Results Participants previously diagnosed with prediabetes (n=220) were originally enrolled in the pilot study. A subset of participants (n=187) met Centers for Disease Control and Prevention (CDC) criteria for starting the program (starters), and a further subset (n=155) met CDC criteria for completing the program (completers) and were both included in analyses. Program starters lost an average of 4.7% (SD 0.4) of baseline body weight after 1 year and 4.2% (SD 0.8) after 2 years, and reduced A1c by mean 0.38% (SD 0.07) after 1 year and 0.43% (SD 0.08) after 2 years. Program completers lost mean 4.9% (SD 0.5) of baseline body weight after 1 year and 4.3% (SD 0.8) after 2 years, and reduced A1c by 0.40% (SD 0.07) after 1 year and 0.46% (SD 0.08) after 2 years. For both groups, neither 2-year weight loss nor A1c results were significantly different from 1-year results. Conclusions Users of the Prevent program experienced significant reductions in body weight and A1c that are maintained after 2 years. Contrary to the

  8. Diabetic foot wounds in haemodialysis patients: 2-year outcome after percutaneous transluminal angioplasty and minor amputation.

    PubMed

    Matsuzaki, Kyoichi; Miyamoto, Akira; Hakamata, Naohiro; Fukuda, Masahiro; Yamauchi, Yasutaka; Akita, Takako; Kuhara, Ryoji; Tezuka, Shingo

    2012-12-01

    Critical limb ischaemia (CLI) is known to be associated with high mortality. In some patients, surgery cannot be performed due to high risk of perioperative death and complications. In other cases, there is only pain at rest but no wound. Therefore, it is difficult to accurately predict the prognosis of individual patients. We examined the prognosis of CLI cases in which therapeutic footwear was made for ambulation after wounds healed. The subjects were 31 haemodialysis patients with diabetic foot wounds, which were treated with percutaneous transluminal angioplasty and minor amputation. The subjects were 22 men and 9 women. Female patients were significantly older than male patients (P = 0.046). Two-year postoperative outcomes were survival in 19 patients and death in 12 patients. Eight of twelve deceased patients had a history of coronary intervention. There were 8 deaths among 13 patients with such history, indicating a marginally significant increase in the mortality rate (P = 0.060). Re-amputation was performed in 6 of 19 patients who survived. Two years postoperatively, 41.9% of patients overall survived without re-amputation. It is important to increase the number of cases for further study to improve the well-being of CLI patients and to examine medical economics. PMID:23095148

  9. Substance use outcomes 51/2 years past baseline for partnership-based, family-school preventive interventions.

    PubMed

    Spoth, Richard L; Randall, G Kevin; Trudeau, Linda; Shin, Chungyeol; Redmond, Cleve

    2008-07-01

    This article reports adolescent substance use outcomes of universal family and school preventive interventions 5(1/2) years past baseline. Participants were 1677 7th grade students from schools (N=36) randomly assigned to the school-based Life Skills Training plus the Strengthening Families Program: For Parents and Youth 10-14 (LST+SFP 10-14), LST-alone, or a control condition. Self-reports were collected at baseline, 6 months later following the interventions, then yearly through the 12th grade. Measures included initiation-alcohol, cigarette, marijuana, and drunkenness, along with a Substance Initiation Index (SII)-and measures of more serious use-frequency of alcohol, cigarette, and marijuana use, drunkenness frequency, monthly poly-substance use, and advanced poly-substance use. Analyses ruled out differential attrition. For all substance initiation outcomes, one or both intervention groups showed significant, positive point-in-time differences at 12th grade and/or significant growth trajectory outcomes when compared with the control group. Although no main effects for the more serious substance use outcomes were observed, a higher-risk subsample demonstrated significant, positive 12th grade point-in-time and/or growth trajectory outcomes for one or both intervention groups on all measures. The observed pattern of results likely reflects a combination of predispositions of the higher-risk subsample, the timing of the interventions, and baseline differences between experimental conditions favoring the control group. PMID:18434045

  10. Rehabilitation outcomes in children with cerebral palsy during a 2 year period

    PubMed Central

    İçağasıoğlu, Afitap; Mesci, Erkan; Yumusakhuylu, Yasemin; Turgut, Selin Turan; Murat, Sadiye

    2015-01-01

    [Purpose] To observe motor and functional progress of children with cerebral palsy during 2 years. [Subjects and Methods] Pediatric cerebral palsy patients aged 3–15 years (n = 35/69) with 24-month follow-up at our outpatient cerebral palsy clinic were evaluated retrospectively. The distribution of cerebral palsy types was as follows: diplegia (n = 19), hemiplegia (n = 4), and quadriplegia (n = 12). Participants were divided into 3 groups according to their Gross Motor Functional Classification System scores (i.e., mild, moderate, and severe). All participants were evaluated initially and at the final assessment 2 years later. During this time, patients were treated 3 times/week. Changes in motor and functional abilities were assessed based on Gross Motor Function Measure-88 and Wee Functional Independence Measure. [Results] Significant improvements were observed in Gross Motor Function Measure-88 and Wee Functional Independence Measure results in all 35 patients at the end of 2 years. The Gross Motor Function Measure-88 scores correlated with Wee Functional Independence Measure Scores. Marked increases in motor and functional capabilities in mild and moderate cerebral palsy patients were observed in the subgroup assessments, but not in those with severe cerebral palsy. [Conclusion] Rehabilitation may greatly help mild and moderate cerebral palsy patients achieve their full potential. PMID:26644677

  11. Motor Testing at 1 Year Improves the Prediction of Motor and Mental Outcome at 2 Years after Perinatal Hypoxic-Ischaemic Encephalopathy

    ERIC Educational Resources Information Center

    van Schie, Petra Em; Becher, Jules G.; Dallmeijer, Annet J.; Barkhof, Frederik; van Weissenbruch, Mirjam M.; Vermeulen, R. Jeroen

    2010-01-01

    Aim: To investigate the predictive value of motor testing at 1 year for motor and mental outcome at 2 years after perinatal hypoxic-ischaemic encephalopathy (HIE) in term neonates. Method: Motor and mental outcome at 2 years was assessed with the Bayley Scales of Infant Development, 2nd edition (BSID-II) in 32 surviving children (20 males, 12…

  12. A Multicenter, Single-Blind Randomized, Controlled Study of a Volumizing Hyaluronic Acid Filler for Midface Volume Deficit: Patient-Reported Outcomes at 2 Years

    PubMed Central

    Few, Julius; Cox, Sue Ellen; Paradkar-Mitragotri, Deepali; Murphy, Diane K.

    2015-01-01

    Background Juvéderm Voluma XC is a volumizing hyaluronic acid filler used for correction of age-related midface volume deficit (MVD). Objectives The effectiveness of Juvéderm Voluma XC was examined from the patient perspective. Methods Patients with moderate to severe age-related MVD (N = 235) received Juvéderm Voluma XC. At quarterly follow-up visits for 2 years, patients rated treatment outcomes on the Global Aesthetic Improvement Scale (GAIS), overall satisfaction with facial appearance, satisfaction with midfacial regions, achievement of treatment goal, Look and Feel of the Midface (LAFM), and Self-Perception of Age (SPA). Patients recorded treatment-site responses in 30-day diaries. Results At 6 months and 2 years after treatment, 92.8% and 79.0% of patients, respectively, rated their cheek volume as improved/much improved on the GAIS. Improvement in satisfaction with facial appearance was noted by 89.8% of patients at 6 months and 75.8% at 2 years. Increased satisfaction with outer and lower cheek areas and cheek-bone projection and clinically significant improvements in LAFM were noted through month 24. Treatment goals were achieved by 67.8% of patients at 6 months and 49.0% at 2 years. Patients reported looking, on average, 5 years younger at 6 months and 3 years younger at 2 years. The most common treatment site responses were tenderness, swelling, firmness, and lumps/bumps; most were mild to moderate in severity and lasted ≤2 weeks. Conclusions Juvéderm Voluma XC for age-related MVD is effective and well-tolerated from the patient perspective, with results lasting up to 2 years. Level of Evidence 4 Therapeutic PMID:25964628

  13. Comparison of Immediate and 2-Year Outcomes between Excimer Laser-Assisted Angioplasty with Spot Stent and Primary Stenting in Intermediate to Long Femoropopliteal Disease

    PubMed Central

    Chou, Hsin-Hua; Chang, Shang-Hung; Tsai, Yueh-Ju; Hsieh, Chien-An; Cheng, Shih-Tsung; Yeh, Kuan-Hung; Chang, Hern-Jia; Ko, Yu-Lin; Huang, Hsuan-Li

    2013-01-01

    Background. To compare the clinical outcomes between excimer laser-assisted angioplasty (ELA) with spot stent (group A) and primary stenting (group B) in intermediate to long femoropopliteal disease. Methods. Outcomes of 105 patients totaling 119 legs treated with two different strategies were analyzed retrospectively in a prospectively maintained database. Results. Baseline characteristics were similar in both groups. Better angiographic results and lesser increase of serum C-reactive protein levels (0.60 ± 0.72 versus 2.98 ± 0.97 mg/dL, P < 0.001) after the intervention were obtained in Group B. Group A had inferior 1-year outcomes due to higher rate of binary restenosis (67% versus 32%, P = 0.001) and lower rate of primary patency (40% versus 58%, P = 0.039). Rates of amputation-free survival, target vessel revascularization, assisted primary patency, and stent fracture at 24 months were similar in both groups (80% versus 82%, P = 0.979, 65% versus 45%, P = 0.11, 78% versus 80%, P = 0.75 and 6.3% versus 6.8%, P = 0.71, resp.). Conclusion. Greater vascular inflammation after ELA with spot stent resulted in earlier restenosis and inferior 1-year clinical outcomes than primary stenting. This benefit was lost in the primary stenting group at 2 years due to late catch-up restenosis. Active surveillance with prompt intervention was required to maintain the vessel patency. PMID:24381515

  14. Surgical Predictors of Clinical Outcome following Revision ACL Reconstruction

    PubMed Central

    Wright, Rick W.

    2016-01-01

    Objectives: Revision ACL reconstruction has been documented to have worse outcomes compared with primary ACL reconstructions. The reasons why remain unknown. The purpose of this study was to determine either previous or current surgical factors noted at the time of ACL revision reconstruction predicts activity level, sports function, and OA symptoms at two year follow-up. Methods: Revision ACL reconstruction patients were identified and prospectively enrolled between 2006 and 2011. Data collected included baseline demographics, surgical technique and pathology, and a series of validated patient reported outcome instruments (IKDC, KOOS, WOMAC, and Marx activity rating score). Patients were followed up for 2 years, and asked to complete the identical set of outcome instruments. Regression analysis was used to control for age, gender, BMI, activity level, baseline outcome scores, revision number, time since last ACLR, and a variety of previous and current surgical variables, in order to assess the surgical risk factors for clinical outcomes 2 years after revision ACL reconstruction. Results: 1205 patients met the inclusion criteria and were successfully enrolled. 697 (58%) were males, with a median cohort age of 26 years. The median time since their last ACL reconstruction was 3.4 years. Baseline characteristics of the cohort are summarized in Table 1. At 2 years, follow-up was obtained on 82% (989/1205). Both previous as well as current surgical factors were found to be significant drivers of poorer outcomes at 2 years (Table 2). The most consistent surgical factors driving outcome in revision patients were prior surgical technique, prior tibial tunnel position, current femoral fixation and having a notchplasty. Having a previous arthrotomy compared to the one incision technique resulted in significantly poorer outcomes on the IKDC (odds ratio=0.41; 95% CI=0.17-0.95; p=0.037) and KOOS pain, sports/rec, and QOL subscales (OR range=0.23-0.42; 95% CI=0.10-0.97; p<0

  15. Perceived outcomes and satisfaction of Saudi parents and their children following dental rehabilitation under general anesthesia: A 2-year follow-up

    PubMed Central

    El Batawi, Hisham Yehia; Panigrahi, Priyankar; Awad, Manal A.

    2014-01-01

    Purpose: To investigate the perceived clinical outcome and parents’ satisfaction after dental rehabilitation under general anesthesia over a follow-up period of 2 years. Materials and Methods: A prospective study of questionnaire data obtained from 352 pediatric patients before and after treatment of early childhood caries with full dental rehabilitation under general anesthesia. Questionnaires focused on oral symptoms, functional limitations, and emotional and social well-being before and after dental treatment. Cases were followed up for 2 years postoperatively. Results: A dramatic disappearance of symptoms was reported from parents’ perspective. There was a high satisfaction rate (99.14%) also among parents of the children included in the study. Conclusion: Children with early childhood caries do not necessarily express it verbally as pain. The disease has a lot of other expressions affecting children's behavior and habits, including the ability to sleep, thrive, and socialize. This study contributes to the existing literature that full dental rehabilitation under general anesthesia [dental general anesthesia (DGA)] has an immediate positive impact on the physical and social quality of life of children suffering from early childhood caries as well as on their families. Postoperative preventive care, early diagnosis, and treatment of recurrent caries are key factors to maintain postoperative outcome of DGA. PMID:25625072

  16. Myopia Control with a Novel Peripheral Gradient Soft Lens and Orthokeratology: A 2-Year Clinical Trial

    PubMed Central

    Pauné, Jaime; Morales, Hari; Armengol, Jesús; Quevedo, Lluisa; Faria-Ribeiro, Miguel; González-Méijome, José M.

    2015-01-01

    Objective. To evaluate the degree of axial elongation with soft radial refractive gradient (SRRG) contact lenses, orthokeratology (OK), and single vision (SV) spectacle lenses (control) during a period of 1 year before treatment and 2 years after treatment. Methods. This was a prospective, longitudinal, nonrandomized study. The study groups consisted of 30, 29, and 41 children, respectively. The axial length (AL) was measured during 2 years after recruitment and lens fitting. Results. The baseline refractive sphere was correlated significantly (Spearman's Rho (ρ) correlation = 0.542; P < 0.0001) with the amount of myopia progression before baseline. After 2 years, the mean myopia progression values for the SRRG, OK, and SV groups were −0.56 ± 0.51, −0.32 ± 0.53, and −0.98 ± 0.58 diopter, respectively. The results represent reductions in myopic progression of 43% and 67% for the SRRG and OK groups, respectively, compared to the SV group. The AL increased 27% and 38% less in the SRRG and OK groups, respectively compared with the SV group at the 2-year visit (P < 0.05). Axial elongation was not significantly different between SRRG and OK (P = 0.430). Conclusion. The SRRG lens significantly decreased AL elongation compared to the SV control group. The SRRG lens was similarly effective to OK in preventing myopia progression in myopic children and adolescent. PMID:26605331

  17. Impact of baseline anti-cyclic citrullinated peptide-2 antibody concentration on efficacy outcomes following treatment with subcutaneous abatacept or adalimumab: 2-year results from the AMPLE trial

    PubMed Central

    Sokolove, Jeremy; Schiff, Michael; Fleischmann, Roy; Weinblatt, Michael E; Connolly, Sean E; Johnsen, Alyssa; Zhu, Jin; Maldonado, Michael A; Patel, Salil; Robinson, William H

    2016-01-01

    Objectives To examine whether baseline anti-cyclic citrullinated peptide-2 (CCP2) antibody status and concentration correlated with clinical outcomes in patients treated with abatacept or adalimumab on background methotrexate (MTX) in the 2-year AMPLE (Abatacept versus adaliMumab comParison in bioLogic-naïvE rheumatoid arthritis subjects with background MTX) study. Methods In this exploratory analysis, anti-CCP2 antibody concentration was measured at baseline, and antibody-positive patients were divided into equal quartiles, Q1–Q4, representing increasing antibody concentrations. Clinical outcomes analysed by baseline anti-CCP2 status and quartile included change from baseline in disease activity and disability and remission rates. Results Baseline characteristics were generally comparable across quartiles and treatment groups. In both treatment groups, anti-CCP2 antibody-negative patients responded less well than antibody-positive patients. At year 2, improvements in disease activity and disability and remission rates were similar across Q1–Q3, but were numerically higher in Q4 in the abatacept group; in contrast, treatment effects were similar across all quartiles in the adalimumab group. Conclusions In AMPLE, baseline anti-CCP2 positivity was associated with a better response for abatacept and adalimumab. Patients with the highest baseline anti-CCP2 antibody concentrations had better clinical response with abatacept than patients with lower concentrations, an association that was not observed with adalimumab. Trial registration number NCT00929864. PMID:26359449

  18. Safety and Visual Outcome of Visian Toric ICL Implantation after Corneal Collagen Cross-Linking in Keratoconus: Up to 2 Years of Follow-Up

    PubMed Central

    Chelala, Elias; Hamade, Adib; Cherfane, Carole

    2015-01-01

    Purpose. To evaluate the long-term safety and clinical outcome of phakic Visian toric implantable collamer lens (ICL) insertion after corneal collagen cross-linking (CXL) in progressive keratoconus. Methods. This was a retrospective study of 30 eyes (19 patients), with progressive keratoconus, who underwent sequential CXL followed by Visian toric ICL implantation after 6 months. Results. At baseline, 6 eyes had stage I, 14 eyes stage II, and 10 eyes stage III keratoconus graded by Amsler-Krumeich classification. At 6 months after CXL, only K (steep) and K (max) decreased significantly from baseline, with no change in visual acuity or refraction. Flattening in keratometric readings was stable thereafter. There was significant improvement in mean uncorrected distance visual acuity (1.57 ± 0.56 to 0.17 ± 0.06 logMAR, P < 0.001) and mean corrected distance visual acuity (0.17 ± 0.08 to 0.11 ± 0.05 logMAR, P < 0.001) at 12 months after ICL implantation that was maintained at the 2-year follow-up. Mean cylinder power and mean spherical equivalent (SE) also decreased significantly after ICL implantation. A small hyperopic shift in SE (+0.25 D) was observed at 2 years that did not alter visual outcomes. Conclusions. Visian toric ICL implantation following CXL is an effective option for improving visual acuity in patients with keratoconus up to 2 years. PMID:25874116

  19. Rehabilitation Predictors of Clinical Outcome following Revision ACL Reconstruction

    PubMed Central

    Wright, Rick W.; Group, Mars

    2016-01-01

    Objectives: Revision ACL reconstruction has been documented to have worse outcomes compared with primary ACL reconstructions. The reasons why remain unknown. The purpose of this study was to determine whether rehabilitation-related factors prescribed at the time of ACL revision reconstruction significantly influence two year outcomes, as well as the incidence of incurring a subsequent re-operation. Our hypothesis was that immediate versus passive, active range of motion (ROM) and weightbearing will result in improved outcomes without incidence of subsequent surgery. Use of postoperative and functional return to sport braces will not improve return to sports function. Methods: Revision ACL reconstruction patients were identified and prospectively enrolled between 2006 and 2011. Data collected included baseline demographics, surgical technique and pathology, prescribed post-op and rehabilitation instructions (ie. timing of weightbearing, timing of passive and active ROM, use of postoperative and return to sport braces) and a series of validated patient reported outcome instruments (IKDC, KOOS, and Marx activity rating score). Patients were followed up for 2 years, and asked to complete the identical set of outcome instruments. Because meniscal repair, meniscal transplants, HTOs, concurrent ligamentous reconstructions, and certain chondral treatments (ie. microfracture, abrasion arthroplasty, mosiacplasty, etc) are known to affect prescribed rehab treatments, patients with these pathologies were excluded from the analyses. Regression analysis was used to control for age, gender, activity level, baseline outcome scores, and the above-mentioned rehabilitation-related variables, in order to assess the risk factors for clinical outcomes 2 years after revision ACL reconstruction. Results: A total of 843 patients met the inclusion criteria and were successfully enrolled. 482 (57%) were males, with a median cohort age of 27 years. Baseline characteristics of the cohort are

  20. Treatment of posttraumatic and focal osteoarthritic cartilage defects of the knee with autologous polymer-based three-dimensional chondrocyte grafts: 2-year clinical results

    PubMed Central

    Ossendorf, Christian; Kaps, Christian; Kreuz, Peter C; Burmester, Gerd R; Sittinger, Michael; Erggelet, Christoph

    2007-01-01

    Autologous chondrocyte implantation (ACI) is an effective clinical procedure for the regeneration of articular cartilage defects. BioSeed®-C is a second-generation ACI tissue engineering cartilage graft that is based on autologous chondrocytes embedded in a three-dimensional bioresorbable two-component gel-polymer scaffold. In the present prospective study, we evaluated the short-term to mid-term efficacy of BioSeed-C for the arthrotomic and arthroscopic treatment of posttraumatic and degenerative cartilage defects in a group of patients suffering from chronic posttraumatic and/or degenerative cartilage lesions of the knee. Clinical outcome was assessed in 40 patients with a 2-year clinical follow-up before implantation and at 3, 6, 12, and 24 months after implantation by using the modified Cincinnati Knee Rating System, the Lysholm score, the Knee injury and Osteoarthritis Outcome Score, and the current health assessment form (SF-36) of the International Knee Documentation Committee, as well as histological analysis of second-look biopsies. Significant improvement (p < 0.05) in the evaluated scores was observed at 1 and/or 2 years after implantation of BioSeed-C, and histological staining of the biopsies showed good integration of the graft and formation of a cartilaginous repair tissue. The Knee injury and Osteoarthritis Outcome Score showed significant improvement in the subclasses pain, other symptoms, and knee-related quality of life 2 years after implantation of BioSeed-C in focal osteoarthritic defects. The results suggest that implanting BioSeed-C is an effective treatment option for the regeneration of posttraumatic and/or osteoarthritic defects of the knee. PMID:17451597

  1. CAD/CAM ZIRCONIA VS. SLIP-CAST GLASS-INFILTRATED ALUMINA/ZIRCONIA ALL-CERAMIC CROWNS: 2-YEAR RESULTS OF A RANDOMIZED CONTROLLED CLINICAL TRIAL

    PubMed Central

    Çehreli, Murat Cavit; Kökat, Ali Murat; Akça, Kivanç

    2009-01-01

    The aim of this randomized controlled clinical trial was to compare the early clinical outcome of slip-cast glass-infiltrated Alumina/Zirconia and CAD/CAM Zirconia all-ceramic crowns. A total of 30 InCeram® Zirconia and Cercon® Zirconia crowns were fabricated and cemented with a glass ionomer cement in 20 patients. At baseline, 6-month, 1-year, and 2-year recall appointments, Californian Dental Association (CDA) quality evaluation system was used to evaluate the prosthetic replacements, and plaque and gingival index scores were used to explore the periodontal outcome of the treatments. No clinical sign of marginal discoloration, persistent pain and secondary caries was detected in any of the restorations. All InCeram® Zirconia crowns survived during the 2-year period, although one nonvital tooth experienced root fracture coupled with the fracture of the veneering porcelain of the restoration. One Cercon® Zirconia restoration fractured and was replaced. According to the CDA criteria, marginal integrity was rated excellent for InCeram® Zirconia (73%) and Cercon® Zirconia (80%) restorations, respectively. Slight color mismatch rate was higher for InCeram® Zirconia restorations (66%) than Cercon® Zirconia (26%) restorations. Plaque and gingival index scores were mostly zero and almost constant over time. Time-dependent changes in plaque and gingival index scores within and between groups were statistically similar (p>0.05). This clinical study demonstrates that single-tooth InCeram® Zirconia and Cercon® Zirconia crowns have comparable early clinical outcome, both seem as acceptable treatment modalities, and most importantly, all-ceramic alumina crowns strengthened by 25% zirconia can sufficiently withstand functional load in the posterior zone. PMID:19148406

  2. Clinical Outcome of Hypertensive Uveitis

    PubMed Central

    Lewkowicz, Deborah; Willermain, François; Relvas, Lia Judice; Makhoul, Dorine; Janssens, Sarah; Janssens, Xavier; Caspers, Laure

    2015-01-01

    Purpose. To review the clinical outcome of patients with hypertensive uveitis. Methods. Retrospective review of uveitis patients with elevated intraocular pressure (IOP) > 25 mmHg and >1-year follow-up. Data are uveitis type, etiology, viral (VU) and nonviral uveitis (NVU), IOP, and medical and/or surgical treatment. Results. In 61 patients, IOP values are first 32.9 mmHg (SD: 9.0), highest 36.6 mmHg (SD: 9.9), 3 months after the first episode 19.54 mmHg (SD: 9.16), and end of follow-up 15.5 mmHg (SD: 6.24). Patients with VU (n = 25) were older (50.6 y/35.7 y, p = 0.014) and had more unilateral disease (100%/72.22%  p = 0.004) than those with NVU (n = 36). Thirty patients (49.2%) had an elevated IOP before topical corticosteroid treatment. Patients with viral uveitis might have higher first elevated IOP (36.0/27.5 mmHg, p = 0,008) and maximal IOP (40.28/34.06 mmHg, p = 0.0148) but this was not significant when limited to the measurements before the use of topical corticosteroids (p = 0.260 and 0.160). Glaucoma occurred in 15 patients (24.59%) and was suspected in 11 (18.03%) without difference in viral and nonviral groups (p = 0.774). Conclusion. Patients with VU were older and had more unilateral hypertensive uveitis. Glaucoma frequently complicates hypertensive uveitis. Half of the patients had an elevated IOP before topical corticosteroid treatment. PMID:26504598

  3. Clinical outcome of daily dialysis.

    PubMed

    Vos, P F; Zilch, O; Kooistra, M P

    2001-01-01

    Dialysis patients are prone to malnutrition, which may be counteracted by daily home hemodialysis (DHHD, 6 times a week) due to improved clinical outcome and quality of life. Eleven patients were treated with DHHD during 18 months, after a run-in period with three dialysis sessions a week. The total weekly dialysis dose was kept constant during the first 6 months of DHHD, whereupon it was allowed to increase. KT/V was 3.1 +/- 0.5 at baseline, 3.2 +/- 0.5 after 6 months and 4.0 +/- 0.8 at 18 months. Blood pressure decreased from 142 +/- 19/83 +/- 8 to 130 +/- 25/79 +/- 9 mmHg with a more than 50% reduction in antihypertensive medication. Potassium did not change, but potassium binding resins could be stopped almost completely. Bicarbonate increased from 20.6 +/- 3.3 to 23.1 +/- 2.6 mEq/L after 18 months. Patients with a protein intake of less than 1.0 g/kg/d showed a greater increase in body weight (62.3 +/- 6.0 to 65.5 +/- 3.7, P: < 0.05) and normalized protein catabolic rate (nPCR) (0.87 +/- 0.08 to 1.25 +/- 0.36, ns) than patients with acceptable protein intake (>/=1.0 g/kg/d). Phosphate decreased, though not significantly, especially in the latter group. Erythropoietin dose could be reduced from 6400 +/- 5400 U/L at baseline to 5100 +/- 4000 U/L at 18 months. Quality of life improved significantly, especially with to respect to physical condition and mental health. The DHHD markedly improves hemodynamic control and quality of life. Overall nutritional parameters did not change, except cholesterol. Patients with a low protein intake, however, showed a significant increase in body weight, and a greater rise in nPCR. PMID:11158871

  4. Outcome Prediction in Clinical Treatment Processes.

    PubMed

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

    2016-01-01

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

  5. Clinical effectiveness of a one-step self-etch adhesive in non-carious cervical lesions at 2 years.

    PubMed

    Ermis, R Banu; Van Landuyt, Kirsten L; Cardoso, Marcio Vivan; De Munck, Jan; Van Meerbeek, Bart; Peumans, Marleen

    2012-06-01

    A 2-year randomized, controlled prospective study evaluated the clinical effectiveness of a one-step self-etch adhesive and a "gold-standard" three-step etch-and-rinse adhesive in non-carious Class-V lesions. The null hypothesis tested was that the one-step self-etch adhesive does perform clinically equally well as the three-step etch-and-rinse adhesive. A total of 161 lesions in 26 patients were restored with Clearfil AP-X (Kuraray). The restorations were bonded either with the "all-in-one" adhesive Clearfil S3 Bond (Kuraray) or with the three-step etch-and-rinse adhesive Optibond FL (Kerr). The restorations were evaluated at baseline and after 6 months, 1 and 2 years, regarding their retention, marginal adapation, marginal discoloration, caries occurrence, preservation of tooth vitality and post-operative sensivity. Retention loss, severe marginal defects and/or discoloration that needed intervention (repair or replacement) and the occurrence of caries were considered as clinical failures. The recall rate at 2 years was 93.8%. Only one Clearfil S3 Bond restoration was lost at the 2-year recall. All other restorations were clinically acceptable. The number of restorations with defect-free margins decreased severely during the 2-year study period (to 6.7% and 25.3% for Clearfil S3 Bond and Optibond FL, respectively). The Clearfil S3 Bond restorations presented significantly more small marginal defects at the enamel side than the Optibond FL restorations (Clearfil S3 Bond: 93.3%; Optibond FL: 73.3%; p = 0.000). Superficial marginal discoloration increased in both groups (to 53.3% and 36% for Clearfil S3 Bond and Optibond FL, respectively) and was also more pronounced in the Clearfil S3 Bond group (p = 0.007). After 2 years, the simplified one-step self-etch adhesive Clearfil S3 Bond and the three-step etch-and-rinse adhesive Optibond FL were clinically equally successful, even though both adhesives were characterized by progressive degradation in marginal

  6. Evaluation of the medical diagnostic imaging support system based on 2 years of clinical experience.

    PubMed

    Smith, D V; Smith, S; Bender, G N; Carter, J R; Kim, Y; Cawthon, M A; Leckie, R G; Weiser, J C; Romlein, J; Goeringer, F

    1995-05-01

    The Medical Diagnostic Imaging Support (MDIS) system at Madigan Army Medical Center (MAMC) has been operational in a phased approach since March 1992. Since then, nearly all image acquisition has been digital with progressively increasing primary softcopy diagnosis used. More than 375,000 computed radiography (CR) images as well as other modality images have been archived. Considerable experience in installation and implementation phasing has been gained. The location and ergonomic aspects of equipment placement were refined with time. The original clinical scenario was insufficiently detailed and additions were made to facilitate smoother and more complete transition toward a filmless environment. The MDIS system effectiveness and performance have been good in terms of operational workload throughout, background operations, and reliability. The important areas regarding reliability are image acquisition, output, display, database operations, storage, and the local area network. Fail-safe strategies have been continually improved to maintain continuous clinical image availability during the times when the MDIS system or components malfunction. Many invaluable lessons have been learned for effective quality assurance in a hospital-wide picture archiving and communication system. These issues include training, operational quality control, practical aspects of CR image quality, and increased timeliness in the generation and distribution of radiographic reports. Clinical acceptability has been a continuous process as each phase has been implemented. Clinical physicians quickly used the workstations soon after the start of MDIS at MAMC. The major advantage for clinicians has been the amount of time saved when retrieving multimodality images for review. On the other hand, the radiologists have been slower in their acceptance of the workstation for routine use.(ABSTRACT TRUNCATED AT 250 WORDS) PMID:7612705

  7. A 2-year clinical evaluation of a diphenylphosphorylazide-cross-linked collagen membrane for the treatment of buccal gingival recession.

    PubMed

    Zahedi, S; Bozon, C; Brunel, G

    1998-09-01

    To retard collagen membrane enzymatic degradation and to increase its mechanical strength, the diphenylphosphorylazide (DPPA) technique has been demonstrated to achieve natural cross-links between peptide chains of collagen without leaving any foreign product in the cross-linked molecule. In the present prospective clinical trial, the potential of a DPPA-cross-linked type I bovine collagen membrane was evaluated in the healing of 15 buccal soft tissue recessions in 15 patients according to the biological concept of guided tissue regeneration. The recession decreased from 3.7 mm (SD 1.4) at baseline to 0.8 mm (SD 1.2) at 2 years postsurgery, corresponding to a mean root coverage of 82.2% (P <0.0001). Concurrently, the clinical attachment level decreased from 5.4 mm (SD 1.6) at baseline to 1.9 mm (SD 1.2) 2 years postsurgery, corresponding to an average clinical attachment gain of 3.5 mm (SD 1.3) (P <0.0001). The 2-year postsurgical width of the keratinized tissue was not significantly different from baseline values. More than half (53%) of the treated sites showed complete root coverage and about two-thirds (73%) of the total cases showed a 75% to 100% disappearance of the mucogingival defect. The present investigation demonstrated that the use of DPPA-cross-linked collagen membranes in the treatment of human buccal soft tissue recessions results in predictable amounts of root coverage and clinical attachment gain. Long-term randomization controlled clinical trials of this material are needed to fully evaluate its potential for treating periodontal recession. PMID:9776025

  8. Health-Related Quality of Life 2 Years After Treatment With Radical Prostatectomy, Prostate Brachytherapy, or External Beam Radiotherapy in Patients With Clinically Localized Prostate Cancer

    SciTech Connect

    Ferrer, Montserrat Suarez, Jose Francisco; Guedea, Ferran; Fernandez, Pablo; Macias, Victor; Marino, Alfonso; Hervas, Asuncion; Herruzo, Ismael; Ortiz, Maria Jose; Villavicencio, Humberto; Craven-Bratle, Jordi; Garin, Olatz; Aguilo, Ferran

    2008-10-01

    Purpose: To compare treatment impact on health-related quality of life (HRQL) in patients with localized prostate cancer, from before treatment to 2 years after the intervention. Methods and Materials: This was a longitudinal, prospective study of 614 patients with localized prostate cancer treated with radical prostatectomy (134), three-dimensional external conformal radiotherapy (205), and brachytherapy (275). The HRQL questionnaires administered before and after treatment (months 1, 3, 6, 12, and 24) were the Medical Outcomes Study 36-Item Short Form, the Functional Assessment of Cancer Therapy (General and Prostate Specific), the Expanded Prostate Cancer Index Composite (EPIC), and the American Urological Association Symptom Index. Differences between groups were tested by analysis of variance and within-group changes by univariate repeated-measures analysis of variance. Generalized estimating equations (GEE) models were constructed to assess between-group differences in HRQL at 2 years of follow-up after adjusting for clinical variables. Results: In each treatment group, HRQL initially deteriorated after treatment with subsequent partial recovery. However, some dimension scores were still significantly lower after 2 years of treatment. The GEE models showed that, compared with the brachytherapy group, radical prostatectomy patients had worse EPIC sexual summary and urinary incontinence scores (-20.4 and -14.1; p < 0.001), and external radiotherapy patients had worse EPIC bowel, sexual, and hormonal summary scores (-3.55, -5.24, and -1.94; p < 0.05). Prostatectomy patients had significantly better EPIC urinary irritation scores than brachytherapy patients (+4.16; p < 0.001). Conclusions: Relevant differences between treatment groups persisted after 2 years of follow-up. Radical prostatectomy had a considerable negative effect on sexual functioning and urinary continence. Three-dimensional conformal radiotherapy had a moderate negative impact on bowel

  9. Thinking About Clinical Outcomes in Medicaid

    PubMed Central

    Weimar, Dawn; Gray, Jeffrey; Davies, Bud

    2016-01-01

    As Medicaid expands in scope and influence, it is evolving toward being a “purchaser” of quality health care. This commentary discusses measurement and incentivization of clinical outcomes in Medicaid. Advantages and disadvantages of outcome versus process measures are discussed. Distinctions are drawn between the roles of Medicare and Medicaid, including the implications of the growth in Medicaid managed care. Medicaid's influence is particularly notable for obstetric, pediatric, newborn, and long-term care. We provide data on 3 Medicaid outcomes: potentially preventable hospital admissions, readmissions, and complications. The commentary concludes with suggestions for choosing and implementing outcome-oriented value-based purchasing initiatives in Medicaid. PMID:26945295

  10. Outcome instruments for prosthetics: clinical applications.

    PubMed

    Heinemann, Allen W; Connelly, Lauri; Ehrlich-Jones, Linda; Fatone, Stefania

    2014-02-01

    Outcome measurement is crucial to assuring high-quality patient services and improving the quality of services provided by prosthetists. This article summarizes recent evidence on the measurement properties of outcome measures, and updates previously published summaries of outcome instruments. The review focuses on measures of mobility, functional status, quality of life, and patient satisfaction, and includes both performance-based and patient-reported outcomes. Amputation-specific and general measures that are suitable for patients served by prosthetists are discussed. It is encouraging that responsiveness of measures is often reported, as this information is needed to improve clinical utility. PMID:24287247

  11. [Surgical closure of interventricular communications before 2 years of age. Long-term clinical and electrocardiographic course].

    PubMed

    Barrey, C; Petit, J; Losay, J; Lucet, P; Bruniaux, J; Langlois, J; Planche, C; Binet, J P

    1985-11-01

    The long-term follow-up of the first 100 children under 2 years of age, presenting with ventricular septal defect (VSD) who underwent surgical closure between 1972 and 1976 at the Centre Chirurgical Marie-Lannelongue, was studied. Only cases with isolated VSD were taken into account except for 18 cases with ductus arteriosus related to operation and 41 cases with atrial septal defect (ASD) or persistent foramen ovale. This study included clinical and electrocardiographic investigations focused on the long-term follow-up of conduction disorders. Clinical tolerance was excellent with only one Eisenmenger's syndrome induced by a residual VSD. Three secondary cases of aortic regurgitation without present functional repercussions were observed. Conduction disorders were considered as unchanged or even improved. There were no sudden death, no secondary atrioventricular block (AVB), no trifascicular block even after one case with transitory immediate postoperative AVB. PMID:4083976

  12. Latino Adolescents' Experiences of Discrimination across the First 2 Years of High School: Correlates and Influences on Educational Outcomes

    ERIC Educational Resources Information Center

    Benner, Aprile D.; Graham, Sandra

    2011-01-01

    Changes in perceptions of discrimination were examined with 668 Latino students (62% Mexican American; 56% female; M[subscript age] = 14.6 years). Adolescents' reports of discrimination increased across the first 2 years of high school. Perceptions of discrimination were higher for boys and for primary language brokers, as well as for adolescents…

  13. Clinical Outcomes of Characterized Chondrocyte Implantation

    PubMed Central

    Huylebroek, José; Van Der Bauwhede, Jan; Saris, Daniël; Veeckman, Geert; Bobic, Vladimir; Victor, Jan; Almqvist, Karl Fredrik; Verdonk, Peter; Fortems, Yves; Van Lommel, Nel; Haazen, Ludo

    2012-01-01

    Objective: To assess the clinical outcome of patients treated with autologous chondrocyte implantation using ChondroCelect in daily practice. Methods: The study is a cross-sectional analysis of an open-label, noninterventional cohort. The setting was a compassionate use program, involving 43 orthopaedic centers in 7 European countries. The participants were patients treated with ChondroCelect between October 13, 2004 and July 2, 2008. The measurements used were Clinical Global Impression–Improvement and –Efficacy and solicited adverse event reports. Results: Safety data were collected from 334 patients (90.3%), and effectiveness data were from 282 (76.2%) of the 370 patients treated. Mean age at baseline was 33.6 years (range, 12-57 years), 57% were male, and mean body mass index was 25 kg/m2. Mean follow-up was 2.2 years (range, 0.4-4.1 years). A femoral condyle lesion was reported in 66% (288/379) and a patellar lesion in 19% (84/379). Mean lesion size was 3.5 cm2; a collagen membrane was used in 92.4% (328/355). A therapeutic effect was reported in 89% (234/264) of patients overall and in 87% (40/46) of patellar lesion patients. Rates of much or very much improved patients were similar in patients with short- (<18 months: 71% [115/163]) and long-term follow-up (>18 months: 68% [70/103]) (P = 0.68) and were independent of lesion size (>4 cm2: 75.5% [37/49]; ≤4 cm2: 67.7% [111/164]) (P = 0.38). Adverse events were similar to those reported in the randomized trial with the same product, with more arthrofibrosis, more reduced joint mobility, and more crepitations reported in patellar lesions. Overall, less cartilage hypertrophy was noted, probably due to the use of a biological membrane cover. Conclusions: Implantation of ChondroCelect appeared to result in a positive benefit/risk ratio when used in an unselected heterogenous population, irrespective of the follow-up period, lesion size, and type of lesion treated. PMID:26069630

  14. Predicting Clinical Outcomes Using Molecular Biomarkers

    PubMed Central

    Burke, Harry B.

    2016-01-01

    Over the past 20 years, there has been an exponential increase in the number of biomarkers. At the last count, there were 768,259 papers indexed in PubMed.gov directly related to biomarkers. Although many of these papers claim to report clinically useful molecular biomarkers, embarrassingly few are currently in clinical use. It is suggested that a failure to properly understand, clinically assess, and utilize molecular biomarkers has prevented their widespread adoption in treatment, in comparative benefit analyses, and their integration into individualized patient outcome predictions for clinical decision-making and therapy. A straightforward, general approach to understanding how to predict clinical outcomes using risk, diagnostic, and prognostic molecular biomarkers is presented. In the future, molecular biomarkers will drive advances in risk, diagnosis, and prognosis, they will be the targets of powerful molecular therapies, and they will individualize and optimize therapy. Furthermore, clinical predictions based on molecular biomarkers will be displayed on the clinician’s screen during the physician–patient interaction, they will be an integral part of physician–patient-shared decision-making, and they will improve clinical care and patient outcomes. PMID:27279751

  15. Effects of Cognitive Enhancement Therapy on Employment Outcomes in Early Schizophrenia: Results from a 2-Year Randomized Trial

    ERIC Educational Resources Information Center

    Eack, Shaun M.; Hogarty, Gerard E.; Greenwald, Deborah P.; Hogarty, Susan S.; Keshavan, Matcheri S.

    2011-01-01

    Objective: To examine the effects of psychosocial cognitive rehabilitation on employment outcomes in a randomized controlled trial for individuals with early course schizophrenia. Method: Early course schizophrenia outpatients (N = 58) were randomly assigned to cognitive enhancement therapy (CET) or an enriched supportive therapy (EST) control and…

  16. Clinical and fiscal outcomes of utilization review.

    PubMed

    Murray, Mary Ellen; Darmody, Julie V

    2004-01-01

    Concurrent utilization review (UR) is both a quality improvement tool and a cost containment strategy used by managed care organizations. The UR process requires that providers (hospital staff) communicate clinical information about hospitalized patients to payers who evaluate the appropriateness and medical necessity of the planned care. Payers then make a decision whether to certify the care for reimbursement. This study provides data to indicate that denials of certification have little impact on clinical and fiscal outcomes of patient care. PMID:14740580

  17. Cementless anatomical prosthesis for the treatment of 3-part and 4-part proximal humerus fractures: cadaver study and prospective clinical study with minimum 2 years followup

    PubMed Central

    Obert, Laurent; Saadnia, Rachid; Loisel, François; Uhring, Julien; Adam, Antoine; Rochet, Séverin; Clappaz, Pascal; Lascar, Tristan

    2016-01-01

    Introduction: The purpose of this study was to evaluate the functional and radiological outcomes of a cementless, trauma-specific locked stem for 3- and 4-part proximal humeral fractures. Materials and methods: This study consisted of two parts: a cadaver study with 22 shoulders and a multicenter prospective clinical study of 23 fracture patients evaluated at least 2 years after treatment. In the cadaver study, the locked stem (HumelockTM, FX Solutions) and its instrumentation were evaluated. In the clinical study, five senior surgeons at four different hospitals performed the surgical procedures. An independent surgeon evaluated the patients using clinical (Constant score, QuickDASH) and radiological (X-rays, CT scans) outcome measures. Results: The cadaver study allowed us to validate the height landmarks relative to the pectoralis major tendon. In the clinical study, at the review, abduction was 95° (60–160), forward flexion was 108° (70–160), external rotation (elbow at body) was 34° (0–55), the QuickDASH was 31 (4.5–59), the overall Constant score was 54 (27–75), and the weighted Constant score was 76 (31.5–109). Discussion: This preliminary study of hemiarthroplasty (HA) with a locked stem found results that were at least equivalent to published series. As all patients had at least a 2-year follow-up, integration of the locked stem did not cause any specific complications. These results suggest that it is possible to avoid using cement when hemiarthroplasty is performed for the humeral stem. This implant makes height adjustment and transosseous suturing of the tuberosities more reproducible. PMID:27194107

  18. Impact of Nonvascular Thoracic MR Imaging on the Clinical Decision Making of Thoracic Surgeons: A 2-year Prospective Study.

    PubMed

    Ackman, Jeanne B; Gaissert, Henning A; Lanuti, Michael; Digumarthy, Subba R; Shepard, Jo-Anne O; Halpern, Elkan F; Wright, Cameron D

    2016-08-01

    Purpose To determine the impact of nonvascular thoracic magnetic resonance (MR) imaging on the clinical decision making and diagnostic certainty of thoracic surgeons. Materials and Methods Seven thoracic surgeons at Massachusetts General Hospital, an academic quaternary referral hospital, participated in this 2-year, prospective, institution review board-approved, HIPAA-compliant pre- and post-MR imaging survey study after completing a one-time demographic survey. Between July 16, 2013, and July 13, 2015, each time a thoracic surgeon ordered a nonvascular thoracic MR imaging study via radiology order entry, he or she was sent a link to the pre-test survey that ascertained the clinical rationale for MR imaging, the clinical management plan if MR imaging was not an option, and pre-test diagnostic certainty. Upon completion of the MR imaging report, the surgeon was sent a link to the post-test survey assessing if/how MR imaging changed clinical management, the surgeon's comfort with the clinical management plan, and post-test diagnostic certainty. Data were analyzed with Student t, Wilcoxon, and McNemar tests. Results A total of 99 pre- and post-test surveys were completed. Most MR imaging studies (64 of 99 [65%]) were requested because of indeterminate computed tomographic findings. The use of MR imaging significantly reduced the number of planned surgical interventions (P < .001), modified the surgical approach in 54% (14 of 26) of surgical cases, and increased surgeon comfort with the patient management plan in 95% (94 of 99) of cases. Increased diagnostic certainty as a result of MR imaging was highly significant (P < .0001). In 21% (21 of 99) of cases, definitive MR imaging results warranted no further follow-up or clinical care. Conclusion In appropriate cases, assessment with nonvascular thoracic MR imaging substantially affects the clinical decision making and diagnostic certainty of thoracic surgeons. (©) RSNA, 2016 Online supplemental material is available

  19. Clinical outcome measures for Cutaneous Lupus Erythematosus

    PubMed Central

    Albrecht, Joerg; Werth, Victoria P.

    2011-01-01

    Cutaneous lupus erythematosus is a clinically heterogeneous group of rare skin diseases that only rarely have been subjected to controlled clinical trials. This may be have been partly due to a lack of suitable validated outcome instruments. Recently the FDA mandated that organ specific trials for lupus erythematosus need to use a combination of different outcome measures. The patient’s condition needs to be assessed in terms of quality of life, the patient’s global response and organ specific instruments that measure activity of the disease as well as damage due to the disease. For the skin the only formally validated and published instrument is currently the Cutaneous Lupus Erythematosis Disease Area and Severity Index (CLASI). This paper discusses the background of the development of the CLASI as well as issues related to its use and interpretation in the context of clinical research of CLE. PMID:20693208

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

    PubMed

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

    2015-08-01

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

  1. Treatment costs associated with interventional cancer clinical trials conducted at a single UK institution over 2 years (2009–2010)

    PubMed Central

    Liniker, E; Harrison, M; Weaver, J M J; Agrawal, N; Chhabra, A; Kingshott, V; Bailey, S; Eisen, T G G; Corrie, P G

    2013-01-01

    Background: The conduct of clinical trials should be an integral part of routine patient care. Treating patients in trials incurs additional costs over and above standard of care (SOC), but the extent of the cost burden is not known. We undertook a retrospective cost attribution analysis to quantitate the treatment costs associated with cancer clinical trial protocols conducted over a 2 year period. Methods: All patients entered into oncology (non-haematology) clinical trials involving investigational medicinal products in 2009 and 2010 in a single UK institution were identified. The trial protocols on which they were treated were analysed to identify the treatment costs for the experimental arm(s) of the trial and the equivalent SOC had the patient not been entered in the trial. The treatment cost difference was calculated by subtracting the experimental treatment cost from SOC cost. For randomised trials, an average treatment cost was estimated by taking into account the number of arms and randomisation ratio. An estimate of the annual treatment costs was calculated. Results: A total of 357 adult oncology patients were treated on 53 different trial protocols: 40 phase III, 2 randomised II/III and 11 phase II design. A total of 27 trials were academic, non-commercial sponsored trials and 26 were commercial sponsored trials. When compared with SOC, the average treatment cost per patient was an excess of £431 for a non-commercial trial (range £6393 excess to £6005 saving) and a saving of £9294 for a commercial trial (range £0 to £71 480). There was an overall treatment cost saving of £388 719 in 2009 and £496 556 in 2010, largely attributable to pharmaceutical company provision of free drug supplies. Conclusion: On an average, non-commercial trial protocols were associated with a small per patient excess treatment cost, whereas commercial trials were associated with a substantially higher cost saving. Taking into account the total number of patients

  2. Typing of Clinical Mycobacterium avium Complex Strains Cultured during a 2-Year Period in Denmark by Using IS1245

    PubMed Central

    Bauer, Jeanett; Andersen, Åse B.; Askgaard, Dorthe; Giese, Sten B.; Larsen, Birger

    1999-01-01

    In the present study restriction fragment length polymorphism analyses with the recently described insertion sequence IS1245 as a probe was performed with clinical Mycobacterium avium complex strains cultured in Denmark during a 2-year period. The overall aim of the study was to disclose potential routes of transmission of these microorganisms. As a first step, the genetic diversity among isolates from AIDS patients and non-human immunodeficiency virus (HIV)-infected patients was described. In addition, a number of isolates from nonhuman sources cultured during the same period were analyzed and compared to the human isolates. A total of 203 isolates from AIDS patients (n = 90), non-HIV-infected patients (n = 91), and nonhuman sources (n = 22) were analyzed. The presence of IS1245 was restricted to Mycobacterium avium subsp. avium isolates. The majority of human isolates had large numbers of IS1245 copies, while nonhuman isolates could be divided into a high-copy-number group and a low-copy-number group. Groups of identical strains were found to be geographically widespread, comprising strains from AIDS patients as well as strains from non-HIV-infected patients. Samples of peat (to be used as potting soil) and veterinary samples were found to contain viable M. avium isolates belonging to genotypes also found in humans. PMID:9986819

  3. Clinical predictors of outcome in encephalitis.

    PubMed Central

    Kennedy, C R; Duffy, S W; Smith, R; Robinson, R O

    1987-01-01

    Twenty five patients with encephalitis were studied prospectively, and their clinical and virological features compared with outcome. Among 22 patients with laboratory confirmation of virus infection, evidence of direct effect on the central nervous system by the virus occurred significantly more often both in those with a monophasic illness compared with those with a biphasic illness, and in those with focal neurological signs localising in the cerebral hemispheres compared with those without such signs. Young age at presentation, low score on the Glasgow coma scale, disruption of oculocephalic responses, and laboratory evidence of virus infection within the central nervous system were significantly associated with poor outcome. Computed tomography results, concentrations of creatine phosphokinase BB isoenzyme in cerebrospinal fluid, and procoagulant activity in cerebrospinal fluid were not predictive of outcome. PMID:3688920

  4. Clinical and etiological characteristics of enterovirus 71-related diseases during a recent 2-year period in Korea.

    PubMed

    Ryu, Wi-Sun; Kang, Byounghak; Hong, Jiyoung; Hwang, Seoyeon; Kim, Jonghyun; Cheon, Doo-Sung

    2010-07-01

    Human enterovirus 71 (EV 71) has caused large-scale outbreaks of hand-foot-and-mouth disease (HFMD), particularly in the Asian-Pacific region. In this study, we report a major outbreak of EV 71 infection in Korea and describe the clinical differences between EV 71 and non-EV 71 enterovirus infections. We prospectively enrolled patients with suspected viral infections during a recent 2-year period through a nationwide surveillance system. We identified 719 patients with suspected HFMD or herpangina using real-time PCR and genotyping based on VP1 sequence analysis. The major pathogen causing HFMD changed substantially from 2008 to 2009, with EV 71 becoming the most common cause of HFMD in Korea in 2009. We successfully identified the enteroviral genotypes for 218 of the 719 patients. Patients with EV 71 infections tended to be younger than those with non-EV 71 enteroviral infections and presented with HFMD and meningoencephalitis. In addition, the occurrence of fever, headache, and neck stiffness was significantly higher in patients with EV 71 infections. Multivariable analysis showed that for patients presenting with HFMD, fever, or a sore throat, each covariate was independently associated with EV 71 infection; the adjusted odds ratios (with 95% confidence intervals in parentheses) for these variables were 31.86 (10.04 to 101.09), 4.76 (1.71 to 13.25), and 0.18 (0.04 to 0.77), respectively. Our results indicate that EV 71 was a major cause of HFMD in Korea during the study period. In addition, we found that clinical symptoms may be helpful in the early identification of patients with EV 71 infections. PMID:20463159

  5. Minimally Invasive Periodontal Treatment Using the Er,Cr: YSGG Laser. A 2-year Retrospective Preliminary Clinical Study

    PubMed Central

    Dyer, Bret; Sung, Eric C.

    2012-01-01

    Minimally invasive surgery (MIS) using the erbium, chromium: yttrium-scandium-gallium-garnet (Er,Cr:YSGG) laser (Waterlase MD, Biolase, Irvine, CA) to treat moderate to advanced periodontal disease is presented as an alternative to conventional therapies. To date, there are few short- or long-term studies to demonstrate the effects of this laser in treating and maintaining periodontal health. Electronic clinical records from 16 patients – total of 126 teeth, with pocket depths ranging from 4 mm to 9 mm – were treated with the same protocol using the Er,Cr:YSGG laser. The mean baseline probing depths (PD) were 5 mm and clinical attachment levels (CAL) were 5 mm in the 4 - 6 mm pretreated laser group. The mean baseline probing depths were 7.5 and 7.6 mm for PD and CAL respectfully in the 7 – 9 mm pretreatment laser group. At the 2 year mark, the average PD was 3.2 ± 1.1 mm for the 4-6 mm pocket group and the 7-9 mm pocket group had a mean PD of 3.7 ± 1.2 mm. mean CAL was 3.1 ± 1.1 mm for the 4-6 mm group and 3.6 ± 1.2 for the 7-9 mm group with an overall reduction of 1.9 mm and 4.0 mm respectively. At one and two years, both groups remained stable with PD comparable to the three-month gains. The CAL measurements at one and two years were also comparable to the three-month gains. PMID:22615717

  6. Clinical Outcomes after Traumatic Brain Injury.

    PubMed

    Sandsmark, Danielle K

    2016-06-01

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

  7. Psychosocial outcomes in patients with recurrent major depressive disorder during 2 years of maintenance treatment with venlafaxine extended release

    PubMed Central

    Trivedi, Madhukar H.; Dunner, David L.; Kornstein, Susan G.; Thase, Michael E.; Zajecka, John M.; Rothschild, Anthony J.; Friedman, Edward S.; Shelton, Richard C.; Keller, Martin B.; Kocsis, James H.; Gelenberg, Alan

    2013-01-01

    Background Psychosocial outcomes from the Prevention of Recurrent Episodes of Depression with Venlafaxine ER for Two Years (PREVENT) study were evaluated. Methods Adult outpatients with recurrent major depressive disorder (MDD) and response or remission following 6-month continuation treatment with venlafaxine extended release (ER) were randomized to receive venlafaxine ER or placebo for 1 year. Patients without recurrence on venlafaxine ER during year 1 were randomized to venlafaxine ER or placebo for year 2. Psychosocial functioning was assessed using the Quality of Life Enjoyment and Satisfaction Questionnaire—Short Form (Q-LES-Q), Life EnjoymentScale—Short Version (LES-S), Social Adjustment Scale—Self-Report (SAS-SR) total and individual factors, Short Form Health Survey (SF-36) (vitality, social functioning, and role function-emotional items), and Longitudinal Interval Follow-up Evaluation (LIFE). Results At year 1 end, better overall psychosocial functioning was seen among patients randomly assigned to venlafaxine ER (n=129) vs placebo (n=129), with significant differences at end point on SF-36 role function-emotional, Q-LES-Q, and SAS-SR total, and work, house work, social/leisure, and extended-family factor scores (p≤0.05). At year 2 end, significant differences favored venlafaxine ER (n=43) vs placebo (n=40)on SF-36 vitality and rolefunction-emotional, Q-LES-Q, LES-S, LIFE, and SAS-SR total, social/leisure, and extended-family factor scores (p≤0.05). Limitations Patients with chronic MDD or treatment resistance were excluded and long-term specialist care was a financial incentive for treatment compliance. Discontinuation-related adverse events may have compromised the integrity of the treatment blind. Conclusions For patients with recurrent MDD, 2 years’ maintenance therapy with venlafaxine ER may improve psychosocial functioning vs placebo. PMID:20510459

  8. Clinical Outcomes After Anterior Cruciate Ligament Reconstruction

    PubMed Central

    Tibor, Lisa M.; Long, Joy L.; Schilling, Peter L.; Lilly, Ryan J.; Carpenter, James E.; Miller, Bruce S.

    2010-01-01

    Background: Clinical outcomes of autograft and allograft anterior cruciate ligament (ACL) reconstructions are mixed, with some reports of excellent to good outcomes and other reports of early graft failure or significant donor site morbidity. Objective: To determine if there is a difference in functional outcomes, failure rates, and stability between autograft and allograft ACL reconstructions. Data Sources: Medline, Cochrane Central Register of Controlled Trials (Evidence Based Medicine Reviews Collection), Cochrane Database of Systematic Reviews, Web of Science, CINAHL, and SPORTDiscus were searched for articles on ACL reconstruction. Abstracts from annual meetings of the American Academy of Orthopaedic Surgeons, American Orthopaedic Society for Sports Medicine, and Arthroscopy Association of North America were searched for relevant studies. Study Selection: Inclusion criteria for studies were as follows: primary unilateral ACL injuries, mean patient age less than 41 years, and follow-up for at least 24 months postreconstruction. Exclusion criteria for studies included the following: skeletally immature patients, multiligament injuries, and publication dates before 1990. Data Extraction: Joint stability measures included Lachman test, pivot-shift test, KT-1000 arthrometer assessment, and frequency of graft failures. Functional outcome measures included Tegner activity scores, Cincinnati knee scores, Lysholm scores, and IKDC (International Knee Documentation Committee) total scores. Results: More than 5000 studies were identified. After full text review of 576 studies, 56 were included, of which only 1 directly compared autograft and allograft reconstruction. Allograft ACL reconstructions were more lax when assessed by the KT-1000 arthrometer. For all other outcome measures, there was no statistically significant difference between autograft and allograft ACL reconstruction. For all outcome measures, there was strong evidence of statistical heterogeneity between

  9. Patient reported outcomes for patients who returned to sport compared with those who did not after hip arthroscopy: minimum 2-year follow-up.

    PubMed

    Domb, Benjamin G; Dunne, Kevin F; Martin, Timothy J; Gui, Chengcheng; Finch, Nathan A; Vemula, S Pavan; Redmond, John M

    2016-07-01

    Previous studies assessed elite athletes' return to sport (RTS) after hip arthroscopy, but few investigated a cohort including athletes from all levels of sport. This study compared athletes who returned to sport to those who did not, based on four patient-reported outcome (PRO) scores, including the Hip Outcome Score-Sports Specific Subscale (HOS-SSS). Between September 2008 and April 2012, hip arthroscopies were performed on 157 patients (168 hips) who reported playing a sport preoperatively and indicated their level of sports activity post-operatively. Two-year follow-up was available for 148 (94%) amateur and professional athletes with a total of 158 hips. Of these 60 cases (65 hips) did not return to sports (NRTS) and were in the NRTS group. The remaining 88 cases (93 hips) constituted the RTS group. The modified Harris Hip Score, Non-Arthric Hip Score, Hip Outcome-Activities of Daily Living (HOS-ADL), and HOS-SSS were used to assess outcomes. The HOS-SSS was used to assess specific sport-related movement. Both groups demonstrated significant improvement at 2 years post-operatively in visual analog score and four PRO scores (P < 0.001). There was no significant preoperative differences in HOS-SSS scores between groups; however, the RTS group had significantly higher HOS-SSS scores at 1 and 2 years post-surgery. Post-operatively, the RTS group had significantly better ability to jump, land from a jump, stop quickly and perform cutting/lateral movements (P < 0.05). In summary, patients who indicated RTSs demonstrated significantly higher PRO scores and abilities to perform several sport-related movements, compared with patients who did not. PMID:27583148

  10. Patient reported outcomes for patients who returned to sport compared with those who did not after hip arthroscopy: minimum 2-year follow-up

    PubMed Central

    Domb, Benjamin G.; Dunne, Kevin F.; Martin, Timothy J.; Gui, Chengcheng; Finch, Nathan A.; Vemula, S. Pavan; Redmond, John M.

    2016-01-01

    Previous studies assessed elite athletes’ return to sport (RTS) after hip arthroscopy, but few investigated a cohort including athletes from all levels of sport. This study compared athletes who returned to sport to those who did not, based on four patient-reported outcome (PRO) scores, including the Hip Outcome Score—Sports Specific Subscale (HOS-SSS). Between September 2008 and April 2012, hip arthroscopies were performed on 157 patients (168 hips) who reported playing a sport preoperatively and indicated their level of sports activity post-operatively. Two-year follow-up was available for 148 (94%) amateur and professional athletes with a total of 158 hips. Of these 60 cases (65 hips) did not return to sports (NRTS) and were in the NRTS group. The remaining 88 cases (93 hips) constituted the RTS group. The modified Harris Hip Score, Non-Arthric Hip Score, Hip Outcome-Activities of Daily Living (HOS-ADL), and HOS-SSS were used to assess outcomes. The HOS-SSS was used to assess specific sport-related movement. Both groups demonstrated significant improvement at 2 years post-operatively in visual analog score and four PRO scores (P < 0.001). There was no significant preoperative differences in HOS-SSS scores between groups; however, the RTS group had significantly higher HOS-SSS scores at 1 and 2 years post-surgery. Post-operatively, the RTS group had significantly better ability to jump, land from a jump, stop quickly and perform cutting/lateral movements (P < 0.05). In summary, patients who indicated RTSs demonstrated significantly higher PRO scores and abilities to perform several sport-related movements, compared with patients who did not. PMID:27583148

  11. 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

  12. The Clinical Outcome Study for dysferlinopathy

    PubMed Central

    Harris, Elizabeth; Bladen, Catherine L.; Mayhew, Anna; James, Meredith; Bettinson, Karen; Moore, Ursula; Smith, Fiona E.; Rufibach, Laura; Cnaan, Avital; Bharucha-Goebel, Diana X.; Blamire, Andrew M.; Bravver, Elena; Carlier, Pierre G.; Day, John W.; Díaz-Manera, Jordi; Eagle, Michelle; Grieben, Ulrike; Harms, Matthew; Jones, Kristi J.; Lochmüller, Hanns; Mendell, Jerry R.; Mori-Yoshimura, Madoka; Paradas, Carmen; Pegoraro, Elena; Pestronk, Alan; Salort-Campana, Emmanuelle; Schreiber-Katz, Olivia; Semplicini, Claudio; Spuler, Simone; Stojkovic, Tanya; Straub, Volker; Takeda, Shin'ich; Rocha, Carolina Tesi; Walter, M.C.

    2016-01-01

    Objective: To describe the baseline clinical and functional characteristics of an international cohort of 193 patients with dysferlinopathy. Methods: The Clinical Outcome Study for dysferlinopathy (COS) is an international multicenter study of this disease, evaluating patients with genetically confirmed dysferlinopathy over 3 years. We present a cross-sectional analysis of 193 patients derived from their baseline clinical and functional assessments. Results: There is a high degree of variability in disease onset, pattern of weakness, and rate of progression. No factor, such as mutation class, protein expression, or age at onset, accounted for this variability. Among patients with clinical diagnoses of Miyoshi myopathy or limb-girdle muscular dystrophy, clinical presentation and examination was not strikingly different. Respiratory impairment and cardiac dysfunction were observed in a minority of patients. A substantial delay in diagnosis was previously common but has been steadily reducing, suggesting increasing awareness of dysferlinopathies. Conclusions: These findings highlight crucial issues to be addressed for both optimizing clinical care and planning therapeutic trials in dysferlinopathy. This ongoing longitudinal study will provide an opportunity to further understand patterns and variability in disease progression and form the basis for trial design. PMID:27602406

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

    PubMed

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

    2016-03-01

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

  14. Joint unloading implant modifies subchondral bone trabecular structure in medial knee osteoarthritis: 2-year outcomes of a pilot study using fractal signature analysis

    PubMed Central

    Miller, Larry E; Sode, Miki; Fuerst, Thomas; Block, Jon E

    2015-01-01

    Background Knee osteoarthritis (OA) is largely attributable to chronic excessive and aberrant joint loading. The purpose of this pilot study was to quantify radiographic changes in subchondral bone after treatment with a minimally invasive joint unloading implant (KineSpring® Knee Implant System). Methods Nine patients with unilateral medial knee OA resistant to nonsurgical therapy were treated with the KineSpring System and followed for 2 years. Main outcomes included Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain, function, and stiffness subscores and independent core laboratory determinations of joint space width and fractal signature of the tibial cortex. Results WOMAC scores, on average, improved by 92% for pain, 91% for function, and 79% for stiffness over the 2-year follow-up period. Joint space width in the medial compartment of the treated knee significantly increased from 0.9 mm at baseline to 3.1 mm at 2 years; joint space width in the medial compartment of the untreated knee was unchanged. Fractal signatures of the vertically oriented trabeculae in the medial compartment decreased by 2.8% in the treated knee and increased by 2.1% in the untreated knee over 2 years. No statistically significant fractal signature changes were observed in the horizontally oriented trabeculae in the medial compartment or in the horizontal or vertical trabeculae of the lateral compartment in the treated knee. Conclusion Preliminary evidence suggests that the KineSpring System may modify knee OA disease progression by increasing joint space width and improving subchondral bone trabecular integrity, thereby reducing pain and improving joint function. PMID:25670891

  15. Impact of Remote Monitoring on Clinical Outcomes.

    PubMed

    Varma, Niraj; Ricci, Renato Pietro

    2015-12-01

    Follow-up of patients with cardiac implantable electronic devices is challenging due to both their increasing volume and technical complexity coupled to increasing clinical complexity of recipient patients. Remote monitoring (RM) offers an opportunity to resolve some of these difficulties by improving clinic efficiencies and providing a mechanism for device monitoring and patient management. Several recent randomized clinical trials and registries have demonstrated that RM may reduce in-hospital visit numbers, time required for patient follow-up, physician and nurse time, and hospital and social costs. Furthermore, patient retention and adherence to follow-up schedule are significantly improved by RM. Continuous wireless monitoring of data stored in the device memory with automatic alerts allows early detection of device malfunctions and of events, such as atrial fibrillation, ventricular arrhythmias, and heart failure suitable for clinical intervention. Early reaction may improve patient outcome. RM is easy to use and patients showed a high level of acceptance and satisfaction. Implementing RM in daily practice may require changes in clinic workflow. New organizational models promote significant efficiencies regarding physician and nursing time. Data management techniques are under development. Despite these demonstrable advantages of RM, adoption still remains modest, even in health care systems incentivized to use this follow-up method. PMID:26337400

  16. 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. PMID:27572865

  17. Clinical outcomes of acute myocarditis in childhood

    PubMed Central

    Lee, K; McCrindle, B; Bohn, D; Wilson, G; Taylor, G; Freedom, R; Smallhorn, J; Benson, L

    1999-01-01

    OBJECTIVE—To describe clinical outcomes of a paediatric population with histologically confirmed lymphocytic myocarditis.
DESIGN—A retrospective review between November 1984 and February 1998.
SETTING—A major paediatric tertiary care hospital.
PATIENTS—36 patients with histologically confirmed lymphocytic myocarditis.
MAIN OUTCOME MEASURES—Survival, cardiac transplantation, recovery of ventricular function, and persistence of dysrhythmias.
RESULTS—Freedom from death or cardiac transplantation was 86% at one month and 79% after two years. Five deaths occurred within 72 hours of admission, and one late death at 1.9 years. Extracorporeal membrane oxygenation support was used in four patients, and three patients underwent heart replacement. 34 patients were treated with intravenous corticosteroids. In the survivor/non-cardiac transplantation group (n = 29), the median follow up was 19 months (range 1.2-131.6 months), and the median period for recovery of a left ventricular ejection fraction to > 55% was 2.8 months (range 0-28 months). The mean (SD) final left ventricular ejection and shortening fractions were 66 (9)% and 34 (8)%, respectively. Two patients had residual ventricular dysfunction. No patient required antiarrhythmic treatment. All survivors reported no cardiac symptoms or restrictions in physical activity.
CONCLUSIONS—Our experience documents good outcomes in paediatric patients presenting with acute heart failure secondary to acute lymphocytic myocarditis treated with immunosuppression. Excellent survival and recovery of ventricular function, with the absence of significant arrhythmias, continued cardiac medications, or restrictions in physical activity were the normal outcomes.


Keywords: myocarditis; paediatric cardiology; immunosuppression PMID:10409542

  18. A 2-Year, Phase IV, Multicentre, Observational Study of Ranibizumab 0.5 mg in Patients with Neovascular Age-Related Macular Degeneration in Routine Clinical Practice: The EPICOHORT Study

    PubMed Central

    Beatty, Stephen; Perez-Salvador Garcia, Eduardo; Reynders, Stefaan; Si Bouazza, Abdelkader; Pilz, Stefan

    2014-01-01

    Purpose. To assess the safety profile of ranibizumab 0.5 mg in patients with neovascular age-related macular degeneration (nAMD) in routine clinical practice. Methods. This 2-year, multicentre, observational study was conducted to capture real-world early practice and outcomes across Europe, shortly after European licensing of ranibizumab for nAMD. Being observational in nature, the study did not impose diagnostic/therapeutic interventions/visit schedule. Patients were to be treated as per the EU summary of product characteristics (SmPC) in effect during the study. Key outcome measures were incidence of selected adverse events (AEs), treatment exposure, bilateral treatment, compliance to the EU SmPC, and best-corrected visual acuity (BCVA) over 2 years. Results. 755 of 770 patients received treatment. Ranibizumab was generally well tolerated with low incidence of selected AEs (0%–1.9%). Patients received 6.2 (mean) injections and 133 patients received bilateral treatment over 2 years. Protocol deviation to treatment compliance was reported in majority of patients. The observed decline in mean BCVA (Month 12, +1.5; Month 24, –1.3 letters) may be associated with undertreatment as suggested by BCVA subgroup analysis. Conclusion. The EPICOHORT study conducted in routine clinical practice reinforces the well-established safety profile of ranibizumab in nAMD. In early European practice it appeared that the nAMD patients were undertreated. PMID:24868458

  19. Long-term outcome after whiplash injury. A 2-year follow-up considering features of injury mechanism and somatic, radiologic, and psychosocial findings.

    PubMed

    Radanov, B P; Sturzenegger, M; Di Stefano, G

    1995-09-01

    With the increased incidence of whiplash injury following the introduction of compulsory car seat belts, a large number of reports have dealt with the aftermath of this condition. Previous studies, however, focused on somatic symptoms on the one hand or considered only psychological or neuropsychological variables on the other hand, often in loosely defined or selected groups of patients. No study so far has analyzed the long-term outcome in a nonselected group of patients using a clear injury definition considering patient history; somatic, radiologic, and neuropsychological findings; and features of the injury mechanisms assessed soon after trauma and during follow-up. the present investigation was designed to assess these combined factors. According to a strict definition of whiplash injury, we assessed a consecutive nonselected sample of 117 patients with recent injury who had similar sociocultural and educational backgrounds. The patients had been in automobile crashes and were all equally covered by accident insurance according to the country-wide scheme. Initial examination was performed 7.2 +/- 4.2 days after trauma, and follow-up examinations 3, 6, 12, and 24 months later. At baseline, features of injury mechanism, subjective complaints, and different aspects of patient history were documented and cervical spine X rays performed. At all examinations patients underwent neurologic examination and cognitive and psychosocial factor assessment. At 2 years, patients were divided into symptomatic and asymptomatic groups and then compared with regard to the initial findings. In addition, symptomatic patients who were disabled at the 2-year follow-up examination and symptomatic patients not disabled (that is, they were able to work at the pretraumatic level) were compared regarding initial and 2-year findings. At 2 years, 18% of patients still had injury-related symptoms. With regard to baseline findings the following significant differences were found: Symptomatic

  20. AlphaCor artificial cornea: clinical outcome

    PubMed Central

    Jirásková, N; Rozsival, P; Burova, M; Kalfertova, M

    2011-01-01

    Purpose The purpose of this study was to describe the long-term results of AlphaCor implantations, and to evaluate the main complications and risk factors. Methods Retrospective analysis of preoperative and follow-up data from 15 AlphaCor implantations. Analysis of outcomes, trends, and associations was performed and compared with data from published clinical trials and a literature review. Results The survival rate of the device at 1, 2, and 3 years was 87%, 58%, and 42%, respectively. Postoperative visual acuity ranged from hand movement to 0.8. The most significant complications were stromal melt (nine cases), optic deposition (three eyes), and retroprosthetic membrane formation (three eyes). The most common device-unrelated complication was trauma (three patients). All complications were managed without loss of the eye. Conclusion AlphaCor provides a treatment option for patients with corneal blindness in which a donor tissue graft would not succeed. PMID:21681219

  1. Endoscopic ultrasonic dacryocystorhinostomy: clinical profile and outcomes.

    PubMed

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

    2016-07-01

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

  2. Clinical characteristics and outcomes in biclonal gammopathies.

    PubMed

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

    2016-05-01

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

  3. Near-Infrared Spectroscopy Monitoring, Superior Vena Cava Flow, and Neurodevelopmental Outcome at 2 years in a Cohort of Very Low-Birth-Weight Infants.

    PubMed

    Cerbo, Rosa Maria; Orcesi, Simona; Scudeller, Luigia; Borellini, Martina; Croci, Carolina; Ravelli, Claudia; Masa, Giulia; Paolillo, Piermichele; Manzoni, Paolo; Balottin, Umberto; Stronati, Mauro

    2016-09-01

    Objective We aimed at assessing the association between superior vena cava flow (SVCf), regional (cerebral) tissue oxygen saturation (rSO2), and cerebral fractional oxygen extraction (CFOE) during the first 48 hours of life and 2-years neurodevelopmental outcome of very low-birth-weight infants (VLBW). Methods We prospectively studied 60 VLBW infants admitted to our neonatal intensive care unit; rSO2 was continuously monitored with near-infrared spectroscopy during the first 48 hours of life, SVCf was measured at 4 to 6, 12, 24, and 48 hours, and CFOE was calculated. Neurodevelopmental outcome was assessed at 24 months corrected age. Results The mean gestational age at birth was 27.9 weeks (standard deviation: 2.4); 8 infants died in the first 3 months of life, 6 were lost to follow-up, 46 survived and were followed up. At 24 months, 6 (13%) and 7 (15.2%) infants developed minor and major sequelae, respectively. Infants who died had higher CFOE (p < 0.001) and lower SVCf (p < 0.001) than infants surviving with sequelae. In turn, these had higher SVCf between 24 and 48 hours than those without sequelae (p < 0.001). Conclusion SVCf, rSO2, and CFOE patterns in the first days of life suggest cerebral hyperperfusion, related to loss of autoregulation and/or use of inotropic drugs, as a potential mechanism of cerebral injury. PMID:27603543

  4. Controlled outcome studies of child clinical hypnosis.

    PubMed

    Adinolfi, Barbara; Gava, Nicoletta

    2013-08-01

    Background Hypnosis is defined as "as an interaction in which the hypnotist uses suggested scenarios ("suggestions") to encourage a person's focus of attention to shift towards inner experiences". Aim of the work The focus of this review is to summarize the findings of controlled outcome studies investigating the potential of clinical hypnosis in pediatric populations. We will examine the following themes: anesthesia, acute and chronic pain, chemotherapy-related distress, along with other specific medical issues. Results Hypnosis is an effective method to reduce pain and anxiety before, during and after the administration of anesthetics, during local dental treatments, invasive medical procedures and in burn children. Hypnosis can be successfully used to manage recurrent headaches, abdominal pain, irritable bowel syndrome and chemotherapy-related distress. Hypnosis has an important role in managing symptoms and improving the quality of life of children suffering from asthma and cystic fibrosis and in facilitating the treatment of insomnia in school-age children. Finally, hypnosis can be effectively used for the treatment of some habitual disorders such as nocturnal enuresis and dermatologic conditions, including atopic dermatitis and chronic eczema Conclusions Clinical hypnosis seems to be a useful, cheap and side-effects free tool to manage fear, pain and several kinds of stressful experiences in pediatric populations. Children who receive self-hypnosis trainings achieve significantly greater improvements in their physical health, quality of life, and self-esteem. PMID:24165457

  5. The National Anesthesia Clinical Outcomes Registry.

    PubMed

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

    2015-12-01

    The Anesthesia Quality Institute (AQI) was chartered in 2008 by the American Society of Anesthesiologists to develop the National Anesthesia Clinical Outcomes Registry (NACOR). In this Technical Communication, we will describe how data enter NACOR, how they are authenticated, and how they are analyzed and reported. NACOR accepts case-level administrative, clinical, and quality capture data from voluntarily participating anesthesia practices and health care facilities in the United States. All data are transmitted to the AQI in summary electronic files generated by billing, quality capture, and electronic health care record software, typically on a monthly basis. All data elements are mapped to fields in the NACOR schema in accordance with a publicly available data dictionary. Incoming data are loaded into NACOR by AQI technologists and are subject to both manual and automated review to identify systematically missing elements, miscoding, and inadvertent corruption. Data are deidentified in compliance with Health Insurance Portability and Accountability Act regulations. The database server of AQI, which houses the NACOR database, is protected by 2 firewalls within the American Society of Anesthesiologists' network infrastructure; this system has not been breached. The NACOR Participant User File, a deidentified case-level dataset of information from NACOR, is available to researchers at participating institutions. NACOR architecture and the nature of the Participant User File include both strengths and weaknesses. PMID:26579661

  6. Prediction of Response to Treatment in a Randomized Clinical Trial of Couple Therapy: A 2-Year Follow-Up

    ERIC Educational Resources Information Center

    Baucom, Brian R.; Atkins, David C.; Simpson, Lorelei E.; Christensen, Andrew

    2009-01-01

    Many studies have examined pretreatment predictors of immediate posttreatment outcome, but few studies have examined prediction of long-term treatment response to couple therapies. Four groups of predictors (demographic, intrapersonal, communication, and other interpersonal) and 2 moderators (pretreatment severity and type of therapy) were…

  7. The association of maternal vitamin D status with infant birth outcomes, postnatal growth and adiposity in the first 2 years of life in a multi-ethnic Asian population: the Growing Up in Singapore Towards healthy Outcomes (GUSTO) cohort study.

    PubMed

    Ong, Yi Lin; Quah, Phaik Ling; Tint, Mya Thway; Aris, Izzuddin M; Chen, Ling Wei; van Dam, Rob M; Heppe, Denise; Saw, Seang-Mei; Godfrey, Keith M; Gluckman, Peter D; Chong, Yap Seng; Yap, Fabian; Lee, Yung Seng; Foong-Fong Chong, Mary

    2016-08-01

    Maternal vitamin D status during pregnancy has been associated with infant birth and postnatal growth outcomes, but reported findings have been inconsistent, especially in relation to postnatal growth and adiposity outcomes. In a mother-offspring cohort in Singapore, maternal plasma vitamin D was measured between 26 and 28 weeks of gestation, and anthropometric measurements were obtained from singleton offspring during the first 2 years of life with 3-month follow-up intervals to examine birth, growth and adiposity outcomes. Associations were analysed using multivariable linear regression. Of a total of 910 mothers, 13·2 % were vitamin D deficient (<50 nmol/l) and 26·5 % were insufficient (50-75 nmol/l). After adjustment for potential confounders and multiple testing, no statistically significant associations were observed between maternal vitamin D status and any of the birth outcomes - small for gestational age (OR 1·00; 95 % CI 0·56, 1·79) and pre-term birth (OR 1·16; 95 % CI 0·64, 2·11) - growth outcomes - weight-for-age z-scores, length-for-age z-scores, circumferences of the head, abdomen and mid-arm at birth or postnatally - and adiposity outcomes - BMI, and skinfold thickness (triceps, biceps and subscapular) at birth or postnatally. Maternal vitamin D status in pregnancy did not influence infant birth outcomes, postnatal growth and adiposity outcomes in this cohort, perhaps due to the low prevalence (1·6 % of the cohort) of severe maternal vitamin D deficiency (defined as of <30·0 nmol/l) in our population. PMID:27339329

  8. In-patient rehabilitation: clinical outcomes and cost implications

    PubMed Central

    Bunyan, Mel; Ganeshalingam, Yogesh; Morgan, Ehab; Thompson-Boy, Donvé; Wigton, Rebekah; Holloway, Frank; Tracy, Derek K.

    2016-01-01

    Aims and method A retrospective evaluation was undertaken of the clinical and economic effectiveness of three in-patient rehabilitation units across one London National Health Service trust. Information on admission days and costs 2 years before and 2 years after the rehabilitation placement, length of rehabilitation placement and the discharge pathway was collected on 22 service users. Results There were statistically significant reductions in hospital admission days in the 2 years following rehabilitation compared with the 2 years before, further reflected in significantly lower bed costs. Longer length of rehabilitation placement was correlated with fewer admission days after the placement. A substantial proportion of the sample went into more independent living, some with no further admissions at follow-up. Clinical implications The findings suggest that in-patient rehabilitation is both clinically and cost effective: if benefits are sustained they will offset the cost of the rehabilitation placement. PMID:26958355

  9. Urgent discectomy: Clinical features and neurological outcome

    PubMed Central

    Albert, Ruth; Lange, Max; Brawanski, Alexander; Schebesch, Karl-Michael

    2016-01-01

    Background: To evaluate the clinical features and outcome of patients with progressive neurological deficits due to disc herniation who were treated surgically within 24 h. Methods: We conducted a retrospective analysis of consecutive patients who were admitted between 2004 and 2013 via the Emergency Department. Records were screened for presenting symptoms, neurological status at admission, discharge, and 6-week follow-up. Results: About 72 of 526 patients underwent surgery within 24 h. Magnetic resonance imaging showed lumbar disc herniation in 72 patients. The most common presenting symptoms included radiculopathy (n = 69), the Lasègue sign (n = 60), sensory deficits (n = 57), or motor deficits (n = 47). In addition, 11 patients experienced perineal numbness and 12 had bowel and bladder dysfunction. At discharge, motor and sensory deficits and bowel and bladder dysfunction had improved significantly (P < 0.001, P = 0.029, and P = 0.015, respectively). Conclusion: Motor deficits, sensory deficits, and cauda equina dysfunction were significantly improved immediately after urgent surgery. After 6 weeks, motor and sensory deficits were also significantly improved compared to the neurological status at discharge. Thus, we advocate immediate surgery of disc herniation in patients with acute onset of motor deficits, perineal numbness, or bladder or bowel dysfunction indicative of cauda equina syndrome. PMID:26958423

  10. Cervical Scoliosis: Clinical and Radiographic Outcomes.

    PubMed

    Mesfin, Addisu; Bakhsh, Wajeeh R; Chuntarapas, Tapanut; Riew, K Daniel

    2016-02-01

    Study Design Retrospective study. Objective Cervical scoliosis is a rare condition that can arise from various etiologies. Few reports on the surgical management of cervical scoliosis exist. Our objective was to evaluate clinical and radiographic outcomes following surgical management of cervical scoliosis. Methods We evaluated our cervical spine surgical database for patients with cervical scoliosis (Cobb angle > 10 degrees) from 2005 to 2010. Demographic data including age, gender, diagnoses, and primary versus revision surgery was collected. Surgical data including procedure (anterior versus posterior), estimated blood loss (EBL), length of surgery, length of hospitalization, and complications was recorded. Preoperative and postoperative Cobb angle measurements and Neck Disability Index (NDI) scores were recorded. Results Cervical scoliosis was identified in 18 patients. We excluded 5, leaving 5 men and 8 women with an average age of 50.7 (median 52, range 25 to 65). The average follow-up was 40 months (median 36.5, range 5 to 87). An anterior-only approach was used in 6 cases (average 4 levels fused), 5 cases were posterior-only approach (average 8.7 levels fused), and 2 cases were combined anterior-posterior approach. The EBL was an average of 286 mL (median 150, range 50 to 900), the average surgical time was 266 minutes (median 239, range 136 to 508), and the average hospital stay was 2.7 days (median 2, range 1 to 7). Complications occurred in 7 patients, and 2 developed adjacent segment pathology. The average coronal Cobb angle preoperatively was 35.1 degrees (median 31, range 13 to 63) and corrected was 15.7 degrees (median 10.5, range 2 to 59) postoperatively (p < 0.005). The average NDI preoperatively was 24.9 (median 26, range 6 to 37) and was reduced to 17.8 (median 18, range 7 to 30) postoperatively (p < 0.02). Conclusion Surgical management of cervical scoliosis can result in deformity correction and improvement in patient

  11. Cervical Scoliosis: Clinical and Radiographic Outcomes

    PubMed Central

    Mesfin, Addisu; Bakhsh, Wajeeh R.; Chuntarapas, Tapanut; Riew, K. Daniel

    2015-01-01

    Study Design Retrospective study. Objective Cervical scoliosis is a rare condition that can arise from various etiologies. Few reports on the surgical management of cervical scoliosis exist. Our objective was to evaluate clinical and radiographic outcomes following surgical management of cervical scoliosis. Methods We evaluated our cervical spine surgical database for patients with cervical scoliosis (Cobb angle > 10 degrees) from 2005 to 2010. Demographic data including age, gender, diagnoses, and primary versus revision surgery was collected. Surgical data including procedure (anterior versus posterior), estimated blood loss (EBL), length of surgery, length of hospitalization, and complications was recorded. Preoperative and postoperative Cobb angle measurements and Neck Disability Index (NDI) scores were recorded. Results Cervical scoliosis was identified in 18 patients. We excluded 5, leaving 5 men and 8 women with an average age of 50.7 (median 52, range 25 to 65). The average follow-up was 40 months (median 36.5, range 5 to 87). An anterior-only approach was used in 6 cases (average 4 levels fused), 5 cases were posterior-only approach (average 8.7 levels fused), and 2 cases were combined anterior-posterior approach. The EBL was an average of 286 mL (median 150, range 50 to 900), the average surgical time was 266 minutes (median 239, range 136 to 508), and the average hospital stay was 2.7 days (median 2, range 1 to 7). Complications occurred in 7 patients, and 2 developed adjacent segment pathology. The average coronal Cobb angle preoperatively was 35.1 degrees (median 31, range 13 to 63) and corrected was 15.7 degrees (median 10.5, range 2 to 59) postoperatively (p < 0.005). The average NDI preoperatively was 24.9 (median 26, range 6 to 37) and was reduced to 17.8 (median 18, range 7 to 30) postoperatively (p < 0.02). Conclusion Surgical management of cervical scoliosis can result in deformity correction and improvement in patient

  12. Clinical Outcomes of Minimally Invasive Versus Open TLIF: A Propensity-Matched Cohort Study.

    PubMed

    Djurasovic, Mladen; Rouben, David P; Glassman, Steven D; Casnellie, Michael T; Carreon, Leah Y

    2016-01-01

    In this study, we compare intermediate-term outcomes in minimally invasive surgical transforaminal lumbar interbody fusion (MIS TLIF) to open TLIF. Sixty-four patients who underwent 1- to 2-level MIS TLIF with baseline, 1-, and 2-year outcome measures were identified. These were propensity-matched to a cohort of open TLIF patients based on age, body mass index, sex, smoking status, workers' compensation status, and preoperative outcome measures. At 1 year, both groups had similar improvements in pain and Short-Form 36 (SF-36) Physical Composite Summary (PCS), but the MIS TLIF group had a statistically significantly greater improvement in Oswestry Disability Index (ODI) compared with the open TLIF group. At 2 years, the MIS TLIF group had a statistically significantly greater improvement in pain and ODI compared with the open TLIF group, but no statistically significant difference in SF-36 PCS. Both MIS TLIF and open TLIF lead to significant improvements in clinical outcomes. At 1 year after surgery, MIS TLIF patients had greater improvements in ODI, and at 2 years after surgery, they had greater improvements in pain and ODI. This study showed that the perioperative advantages of MIS TLIF, such as less muscle dissection and faster recovery, continue to be beneficial 1 to 2 years after surgery. PMID:26991587

  13. Temporal Relation Extraction in Outcome Variances of Clinical Pathways.

    PubMed

    Yamashita, Takanori; Wakata, Yoshifumi; Hamai, Satoshi; Nakashima, Yasuharu; Iwamoto, Yukihide; Franagan, Brendan; Nakashima, Naoki; Hirokawa, Sachio

    2015-01-01

    Recently the clinical pathway has progressed with digitalization and the analysis of activity. There are many previous studies on the clinical pathway but not many feed directly into medical practice. We constructed a mind map system that applies the spanning tree. This system can visualize temporal relations in outcome variances, and indicate outcomes that affect long-term hospitalization. PMID:26262376

  14. Defocus Incorporated Soft Contact (DISC) lens slows myopia progression in Hong Kong Chinese schoolchildren: a 2-year randomised clinical trial

    PubMed Central

    Lam, Carly Siu Yin; Tang, Wing Chun; Tse, Dennis Yan-Yin; Tang, Ying Yung; To, Chi Ho

    2014-01-01

    Aims To determine if ‘Defocus Incorporated Soft Contact’ (DISC) lens wear slows childhood myopia progression. Methods A 2-year double-blind randomised controlled trial was carried out in 221 children aged 8–13 years, with myopia between −1.00 and −5.00 Dioptres (D) and astigmatism ≤1.00 D. Subjects were randomly assigned to the DISC (n=111) or single vision (SV; n=110) contact lens group. DISC lenses incorporated concentric rings, which provided an addition of +2.50 D, alternating with the normal distance correction. Refractive error (cycloplegic autorefraction) and axial length were measured at 6-month intervals. Differences between groups were analysed using unpaired t test. Results In total, 128 children completed the study, n=65 in the DISC group and n=63 in the SV group. Myopia progressed 25% more slowly for children in the DISC group compared with those in the control group (0.30 D/year; 95% CI −0.71 to −0.47 vs 0.4 D/year; 95% CI −0.93 to −0.65, p=0.031). Likewise, there was less axial elongation for children in the DISC versus SV groups (0.13 mm/year; 95% CI 0.20 to 0.31 vs 0.18 mm/year; 95% CI 0.30 to 0.43, p=0.009). Treatment effect correlated positively with DISC lens wearing time (r=0.342; p=0.005). Indeed, myopia in children who wore the DISC lenses for five or more hours/day progressed 46% (mean difference=−0.382 D, p=0.001; 95% CI −0.59 to −0.17) less than those in the SV group. Conclusions The daily wearing of DISC lens significantly slowed myopia progression and axial elongation in Hong Kong schoolchildren. The findings demonstrated that simultaneous clear vision with constant myopic defocus can retard myopia progression. PMID:24169657

  15. Implant-connected versus tooth-connected implant-supported partial dentures: 2-year clinical and radiographic comparative evaluation.

    PubMed

    Mostafa, Tamer Mohamed; El-Sheikh, Mohamed M; Abd El-Fattah, Fadel

    2015-01-01

    The purpose of this study was to clinically and radiographically compare implant-connected and tooth-connected implant-supported fixed-detachable mandibular partial dentures. Twenty partially edentulous patients (age range: 25 to 50 years) with mandibular Kennedy Class II configurations were equally divided into two groups receiving a three-unit, fixed-detachable, screw-retained partial denture. Group 1 comprised patients with unilateral missing mandibular molars and premolars. Two implants were placed at the mandibular first premolar and first molar areas. Group 2 comprised patients with missing mandibular molars and second premolars. An implant was placed at the mandibular first molar area, the first premolar was prepared, and a coping was cemented to the tooth with permanent cement. Each case was evaluated clinically and radiographically at baseline (partial denture insertion) and after 6, 12, and 24 months. Data were collected and statistically analyzed using repeated-measures one-way and two-way analysis of variance tests. There was no statistically significant difference between the two groups (P > .05). The implant-tooth-supported prosthesis provided an equally predictable treatment option compared to the totally implant-supported prosthesis in terms of implant survival and loss of marginal bone. PMID:25909533

  16. Risedronate Prevents Bone Loss in Breast Cancer Survivors: A 2-Year, Randomized, Double-Blind, Placebo-Controlled Clinical Trial

    PubMed Central

    Greenspan, Susan L.; Brufsky, Adam; Lembersky, Barry C.; Bhattacharya, Rajib; Vujevich, Karen T.; Perera, Subashan; Sereika, Susan M.; Vogel, Victor G.

    2014-01-01

    Purpose Limited data are available on the efficacy of oral bisphosphonate therapy in breast cancer survivors. Our goal was to examine prevention of breast cancer–related bone loss in this cohort. Patients and Methods Eighty-seven postmenopausal women after chemotherapy for breast cancer were randomly assigned to once-weekly risedronate 35 mg or placebo for 24 months. Outcomes included bone mineral density (BMD) and turnover markers. Results At study initiation, 13% of patients were on an aromatase inhibitor (AI). After 24 months, there were differences of 1.6 to 2.5% (P < .05) at the spine and hip BMD between the placebo and risedronate groups. At study completion, 44% were on an AI. Adjusting for an AI, women on placebo plus AI had a decrease in BMD of (mean ± SE) 4.8% ± 0.8% at the spine and 2.8% ± 0.5% at the total hip (both P < .001). In women on risedronate + AI, the spine decreased by 2.4% ± 1.1% (P < .05) and was stable at the hip. Women in the placebo group not on an AI, maintained BMD at the spine, and had a 1.2% ± 0.5% loss at the total hip (P < .05). Women who received risedronate but no AI had the greatest improvement in BMD of 2.2% ± 0.9% (P < .05) at the total hip. Bone turnover was reduced with risedronate. There were no differences in adverse events between the groups. Conclusion We conclude that in postmenopausal women with breast cancer with or without AI therapy, once-weekly oral risedronate was beneficial for spine and hip BMD, reduced bone turnover, and was well tolerated. PMID:18427147

  17. 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. PMID:21411472

  18. The clinical efficacy of Diphoterine® in the management of cutaneous chemical burns: a 2-year evaluation study

    PubMed Central

    Zack-Williams, S.D.L.; Ahmad, Z.; Moiemen, N.S.

    2015-01-01

    Summary Diphoterine® is an amphoteric irrigating agent for the treatment of chemical burns and rapidly neutralises both acids and alkalis faster than water alone. Diphoterine® is widely used as a first aid agent in a wide range of industries globally. This is a retrospective review of the clinical use of Diphoterine® on chemical burns in an adult tertiary referral burn centre, often with a delay of several hours after the injury. patients admitted with chemical burns within 24 hours of the incident with an abnormal wound pH or in pain, were treated with Diphoterine® spray. Over a 32-month period, 1,875 burn referrals were admitted of which 131 (7%) were chemical burns. Diphoterine® was used in 47 patients (36%). The male to female ratio for the 131 patients was 4:1. Alkaline burns were the commonest (55%). patients who received Diphoterine® were significantly younger (38 vs 43 years; p=0.05) and presented earlier (0.5 vs 2.55 days; p=0.004). There was a significant change in the wound pH pre- and post-application of Diphoterine®, compared to patients who were treated with water irrigation only, with a pH change of 1.076 vs 0.4 (p <0.05). There was no significant difference in the time to healing, the length of hospital stay, or need for surgery. in conclusion, based on our retrospective cohort, Diphoterine® could be a valuable tool for use in hospital settings to neutralise both alkaline and acid burns. PMID:26668556

  19. The clinical efficacy of Diphoterine® in the management of cutaneous chemical burns: a 2-year evaluation study.

    PubMed

    Zack-Williams, S D L; Ahmad, Z; Moiemen, N S

    2015-03-31

    Diphoterine(®) is an amphoteric irrigating agent for the treatment of chemical burns and rapidly neutralises both acids and alkalis faster than water alone. Diphoterine(®) is widely used as a first aid agent in a wide range of industries globally. This is a retrospective review of the clinical use of Diphoterine(®) on chemical burns in an adult tertiary referral burn centre, often with a delay of several hours after the injury. patients admitted with chemical burns within 24 hours of the incident with an abnormal wound pH or in pain, were treated with Diphoterine(®) spray. Over a 32-month period, 1,875 burn referrals were admitted of which 131 (7%) were chemical burns. Diphoterine(®) was used in 47 patients (36%). The male to female ratio for the 131 patients was 4:1. Alkaline burns were the commonest (55%). patients who received Diphoterine(®) were significantly younger (38 vs 43 years; p=0.05) and presented earlier (0.5 vs 2.55 days; p=0.004). There was a significant change in the wound pH pre- and post-application of Diphoterine(®), compared to patients who were treated with water irrigation only, with a pH change of 1.076 vs 0.4 (p <0.05). There was no significant difference in the time to healing, the length of hospital stay, or need for surgery. in conclusion, based on our retrospective cohort, Diphoterine(®) could be a valuable tool for use in hospital settings to neutralise both alkaline and acid burns. PMID:26668556

  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,; Foy, M. H.; Dulchavsky, S. A.; Gibson, C. R.

    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.

  1. Evaluation of nonlinear frequency compression: Clinical outcomes

    PubMed Central

    Glista, Danielle; Scollie, Susan; Bagatto, Marlene; Seewald, Richard; Parsa, Vijay; Johnson, Andrew

    2009-01-01

    This study evaluated prototype multichannel nonlinear frequency compression (NFC) signal processing on listeners with high-frequency hearing loss. This signal processor applies NFC above a cut-off frequency. The participants were hearing-impaired adults (13) and children (11) with sloping, high-frequency hearing loss. Multiple outcome measures were repeated using a modified withdrawal design. These included speech sound detection, speech recognition, and self-reported preference measures. Group level results provide evidence of significant improvement of consonant and plural recognition when NFC was enabled. Vowel recognition did not change significantly. Analysis of individual results allowed for exploration of individual factors contributing to benefit received from NFC processing. Findings suggest that NFC processing can improve high frequency speech detection and speech recognition ability for adult and child listeners. Variability in individual outcomes related to factors such as degree and configuration of hearing loss, age of participant, and type of outcome measure. PMID:19504379

  2. 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. PMID:27089522

  3. Flare, Persistently Active Disease, and Serologically Active Clinically Quiescent Disease in Systemic Lupus Erythematosus: A 2-Year Follow-Up Study

    PubMed Central

    Conti, Fabrizio; Ceccarelli, Fulvia; Perricone, Carlo; Miranda, Francesca; Truglia, Simona; Massaro, Laura; Pacucci, Viviana Antonella; Conti, Virginia; Bartosiewicz, Izabella; Spinelli, Francesca Romana; Alessandri, Cristiano; Valesini, Guido

    2012-01-01

    Objective Several indices have been proposed to assess disease activity in patients with Systemic Lupus Erythematosus (SLE). Recent studies have showed a prevalence of flare between 28–35.3%, persistently active disease (PAD) between 46%–52% and serologically active clinically quiescent (SACQ) disease ranging from 6 to 15%. Our goal was to evaluate the flare, PAD and SACQ rate incidence in a cohort of SLE patients over a 2-year follow-up. Methods We evaluated 394 SLE patients. Flare was defined as an increase in SLEDAI-2K score of ≥4 from the previous visit; PAD was defined as a SLEDAI-2K score of ≥4, on >2 consecutive visits; SACQ was defined as at least a 2-year period without clinical activity and with persistent serologic activity. Results Among the 95 patients eligible for the analysis in 2009, 7 (7.3%) had ≥1 flare episode, whereas 9 (9.4%) had PAD. Similarly, among the 118 patients selected for the analysis in 2010, 6 (5%) had ≥1 flare episode, whereas 16 (13.5%) had PAD. Only 1/45 patient (2.2%) showed SACQ during the follow-up. Conclusion We showed a low incidence of flare, PAD and SACQ in Italian SLE patients compared with previous studies which could be partly explained by ethnic differences. PMID:23029327

  4. 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; McGuire, Kerry; Sargsyan, Ashot

    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.

  5. A Comprehensive Single Institutional Review of 2 Years in a Designated Fast-Track Sarcoma Diagnostic Clinic Linked with a Sarcoma Specialist Advisory Group: Meeting the Target but Failing the Task?

    PubMed Central

    Davidson, Dochka; Wong, Han Hsi; Horan, Gail; Bearcroft, Philip W. P.; Grant, Ian; Grimer, Robert; Hopper, Melanie A.; Hatcher, Helen; Earl, Helena

    2016-01-01

    Background. National guidelines prompted the implementation of a designated two-week wait referral pathway to facilitate the early diagnosis of sarcomas, to improve treatment outcomes. Methods. Patients referred to the Cambridge Sarcoma Diagnostic Clinic between January 2013 and December 2014 were identified through the electronic appointments system. Information was retrospectively retrieved about patient characteristics and details of the diagnostic pathway. Results. 17.3% of patients referred (69/397) were diagnosed with a malignancy. Of these, 59.3% (41/69) had primary sarcomas, 17.4% (12/69) had metastatic cancer, and 23.2% (16/69) had a different primary malignancy. 15% of the 41 sarcomas were <5 cm, 34% in the 5–10 cm range, and 51% >10 cm. Sarcomas diagnosed through this clinic represented 13% (41/315) of sarcomas managed at the centre during the same 2 years. Conclusion. While we achieved the target of 10% (41/397) sarcoma diagnosis rate in the rapid access clinic, only 15% of these were <5 cm better prognosis lesions. This calls into question the “real world” impact of such diagnostic clinics on early diagnosis of sarcomas. In order to enhance generic cancer diagnostic skills, training in these diagnostic clinics could be usefully integrated into national training curricula for both surgical and nonsurgical oncologists. PMID:27340367

  6. Development and Clinical Outcomes of a Dialectical Behavior Therapy Clinic

    ERIC Educational Resources Information Center

    Lajoie, Travis; Sonkiss, Joshua; Rich, Anne

    2011-01-01

    Objective: The authors describe the first 6 months of a dialectical behavior therapy (DBT) clinic operated by trainees in a general adult psychiatry residency program. The purpose of this report is to provide a model for the creation and maintenance of a formalized resident DBT clinic. Methods: Residents participated in the DBT clinic, attended a…

  7. Single Case Research Results as Clinical Outcomes

    ERIC Educational Resources Information Center

    Parker, Richard I.; Hagan-Burke, Shanna

    2007-01-01

    The movement toward evidence-based treatments, interventions, or practices pressures single case research (SCR) to use statistical summaries which have broad credibility. These summaries also need to be easily understood and useful in schools and clinics. To date the effect size families, "proportion of variance" ("R"[superscript 2],…

  8. Academic Transfer Shock and Social Integration: A Comparison of Outcomes for Traditional and Nontraditional Students Transferring from 2-Year to 4-Year Institutions

    ERIC Educational Resources Information Center

    Strahn-Koller, Brooke Lindsey

    2012-01-01

    The purpose of this study was to explore whether traditional and nontraditional students who transferred from 2-year to 4-year institutions experienced differences in transfer shock, academic integration, and social integration. A substantial body of knowledge comparing transfer students to native students on transfer shock exists, while only a…

  9. Metatarsalgia and Morton's Disease: Comparison of Outcomes Between Open Procedure and Neurectomy Versus Percutaneous Metatarsal Osteotomies and Ligament Release With a Minimum of 2 Years of Follow-Up.

    PubMed

    Bauer, Thomas; Gaumetou, Elodie; Klouche, Shahnaz; Hardy, Philippe; Maffulli, Nicola

    2015-01-01

    The present study compared the clinical results of open neurectomy versus a percutaneous procedure for Morton's disease. This was a retrospective study comparing the functional results after 2 surgical procedures: open neurectomy and a percutaneous procedure (with deep transverse metatarsal ligament release and distal metatarsal osteotomies). The present study included 52 patients (26 in each group), and the mean follow-up period was 4 (range 2 to 7) years. The patient evaluation criteria included the presence of painful symptoms of Morton's disease, American Orthopaedic Foot and Ankle Society (AOFAS) functional scale score, patient satisfaction, and delay for recovery. Percutaneous treatment of Morton's disease and open neurectomy produced complete relief of pain in 25 of 26 patients in each group. At the latest follow-up visit, the mean AOFAS score had significantly improved from 36 ± 11 preoperatively to a mean of 89 ± 18 (p < .001). After 2 years, the functional improvement obtained with the percutaneous procedure persisted, with a stable AOFAS score (96 ± 10). Persistent metatarsalgia was reported by patients who had undergone open neurectomy, with a significantly decreased AOFAS score (81 ± 21, p = .009). The percutaneous procedure for Morton's disease provided excellent functional outcomes (AOFAS score >90) significantly more often with a shorter delay than after open neurectomy (p = .03). At the latest follow-up visit, metatarsalgia due to plantar hyperpressure or bursitis and requiring plantar orthotics was present in 11 of 26 patients (44%) after open neurectomy and in 1 of 26 patients (4%) after the percutaneous procedure (p = .002). Percutaneous treatment of Morton's disease is a reliable procedure providing results as good as those after open neurectomy, with significantly better outcomes in the longer term and a lower rate of late metatarsalgia. PMID:25481724

  10. Meniscal allograft transplantation: preoperative assessment, surgical considerations, and clinical outcomes.

    PubMed

    Mascarenhas, Randy; Yanke, Adam B; Frank, Rachel M; Butty, Davietta C; Cole, Brian J

    2014-12-01

    The purpose of this review is to characterize the preoperative assessment of meniscal allograft transplantation (MAT) candidates, to detail MAT surgical techniques, and to evaluate current clinical outcome data on MAT. The MAT candidate is typically less than 50 years old and has a history of knee injury, previous meniscus surgery, and persistent pain. Physical exam generally reveals knee pain with joint line tenderness with normal radiographs and magnetic resonance imaging demonstrating the postmeniscectomized state. There are several common surgical techniques used for transplantation, with fixation achieved through sutures, bony fixation, or a combination of the two. Concomitant procedures such as anterior cruciate ligament reconstruction, osteotomy, and other cartilage procedures are commonly performed. The available short- and long-term studies of clinical outcomes of MAT are variable and difficult to effectively compare due to heterogeneity of the study population and available treatment techniques. In addition, there are no published randomized controlled trials. However, recent reviews and cohort studies of clinical outcomes following MAT have shown that whether performed in isolation or performed with concomitant articular cartilage, realignment, or soft tissue reconstruction procedures MAT outcomes have been acceptable with the majority of studies reporting improved clinical outcomes regardless of the scoring system employed. MAT has proven to be a safe and effective technique in reducing knee pain and improving function in the symptomatic meniscal deficient knee. Evaluation of long-term clinical outcomes is necessary as is evaluation of meniscal replacement alternatives. PMID:24951950

  11. 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…

  12. Clinical Results and Prognostic Factors of Arthroscopic Surgeries for Discoid Lateral Menisci Tear: Analysis of 179 Cases with Minimum 2 Years Follow-up

    PubMed Central

    Ahn, Ji-Yong; Kim, Tae-Han; Jung, Bong-Sung; Ha, Sang-Ho; Lee, Bum-Sik; Chung, Jong-Won; Kim, Jong-Min

    2012-01-01

    Purpose The purpose of this study was to evaluate the clinical results and prognostic factors of arthroscopic surgeries for tears of the discoid lateral menisci. Materials and Methods From March 1997 to September 2005, 260 patients received arthroscopic surgeries due to discoid lateral menisci tears. Among these patients, 179 knees in 168 patients were followed up for at least 2 years and were enrolled into this study. The following prognostic factors were evaluated: sex, age, symptom duration, and type of meniscal tear. Visual analogue score (VAS), Lysholm score, and Ikeuchi grade were assessed as clinical results of arthroscopic surgeries. Results The mean VAS and Lysholm score improved at the last follow-up. According to the Ikeuchi grade, 104 cases were rated as excellent, 51 cases as good, and 23 cases as fair. Male sex (p<0.033), age younger than 20 years (p=0.0474), and symptom duration less than 12 months (p<0.044) were good prognostic factors. However, there was no correlation between tear types of discoid lateral menisci and clinical results. Conclusions Sex, age, and symptom duration could be significant prognostic factors of arthroscopic surgeries for tears of discoid lateral menisci. PMID:22708112

  13. Long-Term Outcome of a Hepatocellular Carcinoma 71/2 Years After Surgery and Repeated Radiofrequency Ablation: Case Report and Review of the Literature

    SciTech Connect

    Thanos, L. Mylona, S.; Nikita, A.; Ptohis, N.; Kelekis, D.A.

    2007-04-15

    An interesting case is presented of a 78-year-old patient with cirrhosis who was managed with combined treatment (surgery and radiofrequency (RF) ablation) for hepatocellular carcinoma (HCC) and has survived for 71/2 years. Elevation of the {alpha}-FP (alpha-fetoprotein) levels was noted 2 years after surgery. CT demonstrated two lesions: one central at the remaining right liver lobe, and the other at the excision site. Biopsy of the lesions confirmed the diagnosis of HCC for both of them. RF ablation of these two lesions was performed in one session with technical success. Four and a half years after the first RF ablation a new recurrence was demonstrated at the CT follow-up control. RF ablation was again applied successfully. The imaging findings and the therapeutic percutaneous management of this patient along with the natural course of HCC and its recurrence are discussed, and the literature concerning risk factors is reviewed.

  14. Clinical Outcomes of Infrapopliteal Angioplasty in Patients With Critical Limb Ischemia

    PubMed Central

    Ryu, Hyeon Min; Kim, Jung-Sun; Ko, Young Guk; Hong, Myeong-Ki; Jang, Yangsoo

    2012-01-01

    Background and Objectives With recent advances in equipment and techniques, infrapopliteal angioplasty has shown results that are comparable to those of surgical bypass in patients with critical limb ischemia (CLI). In this study, we evaluated the efficacy and the feasibility of infrapopliteal angioplasty in patients with CLI. Subjects and Methods Between March 2002 and May 2008, infrapopliteal angioplasty was performed on 118 limbs of 101 patients (79 males; mean age 66 years) with CLI (Rutherford category 4, 5 or 6). Freedom from reintervention, limb salvage, and overall survival were analyzed. Results The median follow-up duration was 30 months. Initial technical and clinical success rates were 69.5% and 83.1%, respectively. No major complication requiring surgical intervention developed after angioplasty. Among 82 limbs with initial technical success, the rate of freedom from any reintervention at 2 years was 70.7% and that from limb salvage was 97.6%. Young age and Rutherford category 6 at initial presentation were independent predictors associated with poor 2 year primary patency in these patients with CLI. Overall survival at 1 year was 86.4% and that at 2 years 76.3%. A history of cerebrovascular accident was an independent predictor associated with poor 2 year survival in these patients. Conclusion Infrapopliteal angioplasty as a primary choice of treatment in CLI patients showed favorable clinical outcomes and feasibility. PMID:22563339

  15. Functional outcomes for clinical evaluation of implant restorations.

    PubMed

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

    2013-01-01

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

  16. Nutrition and Chronic Wounds: Improving Clinical Outcomes.

    PubMed

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

    2016-09-01

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

  17. Bioplastique at 6 years: clinical outcome studies.

    PubMed

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

    1997-11-01

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

  18. Effect of Serum Growth Differentiation Factor-15 and the Syntax Score on 2-Year Outcomes in Patients With Acute Coronary Syndrome.

    PubMed

    Dominguez-Rodriguez, Alberto; Abreu-Gonzalez, Pedro; Avanzas, Pablo; Consuegra-Sanchez, Luciano

    2016-05-15

    Growth differentiation factor-15 (GDF-15) is produced by cardiomyocytes and atherosclerotic lesions under stress conditions, but little is known about its relation with severity and complexity of coronary lesions. The aim of this study was to investigate the association between GDF-15 and the syntax score for risk prediction of major adverse cardiovascular events (MACE) at 2-year follow-up in patients with non-ST-segment elevation acute coronary syndrome (NSTEACS). This is a prospective cohort study of 502 patients with NSTEACS. The syntax score was calculated from baseline coronary angiography. Blood samples were obtained at study entry for the assessment of GDF-15 and high-sensitivity C reactive protein. One hundred and three patients (20.5%) showed MACE at 2-year follow-up. Patients who developed MACE had greater GDF-15 concentrations and syntax score (p <0.001) compared to patients who did not. There was a positive, but moderate, correlation between GDF-15 and syntax score (ρ = 0.45, p <0.0001). On Cox regression analysis, only GDF-15 levels (p <0.001), body mass index (p = 0.04), and syntax score (p <0.001) remained independent predictors of the MACE. The area under the curve of GDF-15 (0.912, 95% confidence interval 0.894 to 0.944) was significantly greater compared to high-sensitivity C reactive protein and syntax score. In conclusion, in patients with NSTEACS, levels of GDF-15 at admission were correlated with the syntax score and independently associated with an increased risk of MACE during 2-year follow-up. PMID:27013387

  19. 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). PMID:26677937

  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. Clinical outcomes for Conduits and Scaffolds in peripheral nerve repair

    PubMed Central

    Gerth, David J; Tashiro, Jun; Thaller, Seth R

    2015-01-01

    The gold standard of peripheral nerve repair is nerve autograft when tensionless repair is not possible. Use of nerve autograft has several shortcomings, however. These include limited availability of donor tissue, sacrifice of a functional nerve, and possible neuroma formation. In order to address these deficiencies, researchers have developed a variety of biomaterials available for repair of peripheral nerve gaps. We review the clinical studies published in the English literature detailing outcomes and reconstructive options. Regardless of the material used or the type of nerve repaired, outcomes are generally similar to nerve autograft in gaps less than 3 cm. New biomaterials currently under preclinical evaluation may provide improvements in outcomes. PMID:25685760

  2. Posterolateral instrumented fusion with and without transforaminal lumbar interbody fusion for the treatment of adult isthmic spondylolisthesis: A randomized clinical trial with 2-year follow-up

    PubMed Central

    Etemadifar, Mohammad Reza; Hadi, Abdollah; Masouleh, Mehran Feizi

    2016-01-01

    Background: Spondylolisthesis is a common cause of surgery in patients with lower back pain. Although posterolateral fusion and pedicle screw fixation are a relatively common treatment method for the treatment of spondylolisthesis, controversy exists about the necessity of adding interbody fusion to posterolateral fusion. The aim of our study was to assess the functional disability, pain, and complications in patients with spondylolisthesis treated by posterolateral instrumented fusion (PLF) with and without transforaminal lumbar interbody fusion (TLIF) in a randomized clinical trial. Materials and Methods: From February 2007 to February 2011, 50 adult patients with spondylolisthesis were randomly assigned to be treated with PLF or PLF+TLIF techniques (25 patients in each group) by a single surgeon. Back pain, leg pain, and disability were assessed before treatment and until 2 years after surgical treatment using visual analog scale (VAS) and oswestry disability index (ODI). Patients were also evaluated for postoperative complications such as infection, neurological complications, and instrument failure. Results: All patients completed the 24 months of follow-up. Twenty patients were females and 30 were males. Average age of the patients was 53 ± 11 years for the PLF group and 51 ± 13 for the PLF + TLIF group. Back pain, leg pain, and disability score were significantly improved postoperatively compared to preoperative scores (P < 0.001). At 3 months of follow-up, there was no statistically significant difference in VAS score for back pain and leg pain in both groups; however, after 6 months and 1 year and 2 years follow-up, the reported scores for back pain and leg pain were significantly lower in the PLF+TLIF group (P < 0.05). The ODI score was also significantly lower in the PLF+TLIF group at 1 year and 2 years of follow-up (P < 0.05). One screw breakage and one superficial infection occurred in the PLF+TLIF group, which had no statistical significance (P = 0

  3. Children who screen positive for autism at 2.5 years and receive early intervention: a prospective naturalistic 2-year outcome study

    PubMed Central

    Spjut Jansson, Birgitta; Miniscalco, Carmela; Westerlund, Joakim; Kantzer, Anne-Katrin; Fernell, Elisabeth; Gillberg, Christopher

    2016-01-01

    Background Previous research has stressed the importance of early identification and intervention for children with autism spectrum disorders. Methods Children who had screened positive for autism at the age of 2.5 years in a general population screening and then received a diagnosis of autism spectrum disorder were enrolled in an intervention program provided by Swedish habilitation services. The following interventions were available: a comprehensive intervention based on Applied Behavior Analysis – Intensive Learning (IL) – in two settings, which included home- and preschool-based (IL Regular) and only home-based (IL Modified) and eclectic interventions. Results There was considerable variability in terms of outcome, but intervention group status was not associated with any of the chosen outcome variables. Conclusion The main finding was that the type of intervention was not critical for outcome of adaptive or global functioning. The variability in outcome demonstrates the need for continuous assessments and evaluation of the child’s function and behavior throughout the intervention period. PMID:27621636

  4. Clinical Outcomes of Medial Meniscus Posterior Root Tears

    PubMed Central

    Krych, Aaron John; Reardon, Patrick J.; Pareek, Ayoosh; Peter, Logan; Dahm, Diane L.; Levy, Bruce A.; Stuart, Michael J.

    2016-01-01

    Objectives: Medial meniscus posterior root tears (MMPRTs) present a unique challenge for both patients and surgeons as these tears have shown to be biomechanically equivalent to complete meniscectomy. However, little is known about the natural history of these lesions. Therefore, the purpose of this study is to describe the clinical course of MMPRTs with respect to subsequent operative and non-operative treatments, and associated comorbidities. Methods: Over 2600 MRIs were identified by searching radiologist reads for the terms “root” or “root tear” from 2005-2013. Presence or absence of MMPRTs and other associated boney, meniscal, or ligamentous injuries were identified and recorded. Of these MRIs, 102 MRIs from 102 patients who had unrepaired MMPRTs with minimum 2-year follow-up and no prior ligamentous surgery were followed. These MRIs were evaluated to confirm the presence of a meniscal root tear and the presence or absence of associated meniscal or ligamentous injuries, as well as meniscal extrusion, subchondral edema, or insufficiency fractures. Chart review was performed to obtain the treatment summary after diagnosis. Radiographs from before and after the diagnosis of MMPRT were reviewed and Kellgren-Lawrence scores were determined. Finally, the association between concomitant boney, ligamentous, or meniscal injuries, patient factors, and rate of arthroplasty, as well as final Kellgren-Lawrence scores were evaluated. Chi-square analysis was used for categorical variables, and Wilcoxon Rank-Sums was used for continuous variables. Kaplan-Meier analysis was used to evaluate the effect of meniscal extrusion on the time-dependant rate of arthroplasty. Results: 104 patients (43 M:61F) were diagnosed with MMPRTs at a mean age of 54±13. These patients were followed for a mean of 66±26 months. 75 (74%) patients had associated meniscal extrusion, 64 (62%) had associated subchondral edema, and 14 (13%) had associated insufficiency fractures at the time of

  5. 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. PMID:23809977

  6. Outcomes of Type II Superior Labrum, Anterior to Posterior (SLAP) Repair: Prospective Evaluation at a minimum 2-year follow-up

    PubMed Central

    Friel, Nicole A.; Karas, Vasili; Slabaugh, Mark A.; Cole, Brian J.

    2013-01-01

    Hypothesis Patients with type II superior labrum, anterior to posterior (SLAP) lesions will have improved function and decrease pain at a minimum two years after arthroscopic SLAP repair using bioabsorbable suture anchor fixation. Materials and Methods The study population consisted of 48 patients who underwent arthroscopic SLAP repair. Subjective shoulder scores, range of motion, and strength (post-operative only) were assessed pre-operatively and at a minimum of two years post-operatively. Results At an average of 3.4 years following surgery, statistically significant improvement was seen in ASES, UCLA, SST, CADL, VAS, and SF-12 physical outcome scores. Improvements were made in forward flexion, abduction, external rotation, and internal rotation. Subgroup analysis of non-athletes, non-overhead athletes, recreational overhead athletes, and collegiate overhead athletes showed pre- to post-operative improvements in subjective outcomes scores. Overhead laborers and non-laborers subgroups also showed pre- to post-operative improvements in subjective shoulder scores. Discussion On the basis of this data, arthroscopic SLAP repair of type II lesions with bioabsorbable suture anchors provides a significant improvement in functional capacity and pain relief. No differences were seen between the outcomes of non-athletes, non-overhead athletes, recreational overhead athletes, and collegiate overhead athletes, suggesting that SLAP type II repair is successful independent of the patient’s vocation or sport. Level of Evidence IV, Case Series, Treatment Study PMID:20554453

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

    PubMed

    Henggeler, Scott W; Schaeffer, Cindy M

    2016-09-01

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

  8. Outcome Markers for Clinical Trials in Cerebral Amyloid Angiopathy

    PubMed Central

    Greenberg, Steven M.; Rustam Al-Shahi, Salman; Biessels, Geert Jan; van Buchem, Mark; Cordonnier, Charlotte; Lee, Jin-Moo; Montaner, Joan; Schneider, Julie A.; Smith, Eric E; Vernooij, Meike; Werring, David J.

    2014-01-01

    Efforts are underway for early-phase trials of candidate therapies for cerebral amyloid angiopathy (CAA), an untreatable cause of hemorrhagic stroke and vascular cognitive impairment. A major barrier to these trials is the lack of consensus on measuring treatment effectiveness. We review a range of potential outcome markers for CAA against the ideal criteria of being clinically meaningful, closely reflective of biological progression, efficient for smaller/shorter trials, reliably measurable, and cost effective. In practice, outcomes tend either to have high clinical salience but relatively low statistical efficiency and thus more applicability for later phase studies, or greater statistical efficiency but more limited clinical meaning. The most statistically efficient outcomes are those that are potentially reversible with treatment, though their clinical significance remains unproven. Many of the candidate outcomes for CAA trials are likely to be applicable to other small vessel brain diseases as well. Considerations emerging from this review outline a path towards rapid and efficient testing of emerging candidate therapies for CAA and other small vessel diseases. PMID:24581702

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

    PubMed Central

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

    2016-01-01

    Objective The objective of this paper is to assess the reliability and validity of the Spanish translation of the Clinical Outcomes in Routine Evaluation – Outcome Measure, a 34-item self-report questionnaire that measures the client’s status in the domains of Subjective well-being, Problems/Symptoms, Life functioning, and Risk. Method Six hundred and forty-four adult participants were included in two samples: the clinical sample (n=192) from different mental health and primary care centers; and the nonclinical sample (n=452), which included a student and a community sample. Results The questionnaire showed good acceptability and internal consistency, appropriate test–retest reliability, and acceptable convergent validity. Strong differentiation between clinical and nonclinical samples was found. As expected, the Risk domain had different characteristics than other domains, but all findings were comparable with the UK referential data. Cutoff scores were calculated for clinical significant change assessment. Conclusion The Spanish version of the Clinical Outcomes in Routine Evaluation – Outcome Measure showed acceptable psychometric properties, providing support for using the questionnaire for monitoring the progress of Spanish-speaking psychotherapy clients. PMID:27382288

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

    PubMed Central

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

    2010-01-01

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

  11. Preoperative indicators of clinical outcome following stereotaxic pallidotomy.

    PubMed

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

    1997-10-01

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

  12. What are the outcomes of an industrial remediation on a metal-impacted hydrosystem? A 2-year field biomonitoring of the filter-feeding bivalve Corbicula fluminea.

    PubMed

    Arini, A; Daffe, G; Gonzalez, P; Feurtet-Mazel, A; Baudrimont, M

    2014-08-01

    The Riou-Mort watershed (southwest France) exhibits high metal contaminations (Cd and Zn) related to an important mining past. In this context, a remediation process has been implemented in 2007 to reduce the watershed contamination. The aim of this study was to assess the early effectiveness of the remediation process on the hydrosystem contamination state. A biomonitoring was realized over two years (2008-2010) with the filter-feeding bivalve Corbicula fluminea, exposed along a contamination gradient. Several biological parameters were monitored: (1) Cd and Zn bioaccumulation, (2) Metallothionein (MT) production as detoxification mechanism, (3) differential gene expression (cat, sod, gst, 12S, cox1, mt). The physicochemical data highlighted strong metal contamination persistence in the river water and failed to demonstrate a significant decrease of metal contamination during the 2-year monitoring. The bioaccumulation results confirmed the persistence of a water contamination despite remediation works, with maximum values measured downstream from the industrial site (Joany). The bioaccumulation increased in 2010, reaching 69.3±5.3 μg Cd g(-1) DW at Joany in July 2010, whereas it did not exceed 1.4±0.2 μg Cd g(-1) DW at the reference site throughout the biomonitoring. MT concentrations were closely related to the contamination gradient, especially at Joany, demonstrating their strong involvement in the detoxification processes. The mt gene induction was strongly correlated to the MT and metal concentrations. The gene inductions of cat, sod, gst and 12S were correlated to both the metal concentrations and the seasonal variations, especially temperatures. This suggests that environmental factors require serious consideration for the interpretation of bioaccumulation kinetics and thus for the assessment of the remediation effectiveness. Consequently, the whole results did not yet highlight strong beneficial effects of remediation work on the hydrosystem

  13. Obsessionality in eating-disorder patients: relationship to clinical presentation and two-year outcome.

    PubMed

    Zubieta, J K; Demitrack, M A; Fenick, A; Krahn, D D

    1995-01-01

    Obsessionality and obsessive-compulsive symptoms have been regarded as important characteristics in the clinical presentation of the eating disorders. In this report, we examined the relation between obsessionality and the clinical presentation and outcome of a sample of eating-disordered patients. Self-rated obsessional symptoms, defined by the obsessive-compulsive subscale of the Symptom Checklist 90 (revised version), were compared with presenting clinical symptomatology, and scores on the Eating Disorder Inventory (EDI) and Beck Depression Inventory (BDI) in a sample of 110 consecutively evaluated women who met DSM-IIIR criteria for eating disorders. Forty patients were contacted for a follow-up investigation, 2 years after the initial evaluation. Higher obsessive-compulsive subscale scores at presentation were associated with more severe dieting, a greater number of psychiatric hospitalizations, and higher EDI, SCL-90R and BDI scores. Initial obsessive-compulsive scores did not predict the subsequent outcome of a sample of these patients in the community. However, elevated obsessive-compulsive scores obtained at follow-up were associated with the presence of lower body weight and more severe eating-disorder symptoms at that time. These results support the hypothesis that elevated obsessionality is associated with more severe eating disorder symptomatology. In addition, obsessional symptoms change along with those of the eating disorder, and their persistence may be associated with a poorer outcome. PMID:8847659

  14. 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…

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

    PubMed

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

    2016-06-01

    This clinical report describes how to achieve predictable outcomes for anterior teeth esthetic restorations with porcelain laminate veneers by associating the digital planning and design of the restoration with interim restorations. The previous digital smile design of the restoration eliminates the communication barrier with the patient and assists the clinician throughout patient treatment. Interim restorations (diagnostic mock-ups) further enhance communication with the patient and prevent unnecessary tooth reduction for conservative tooth preparation. Adequate communication between patient and clinician contributes to successful definitive restorations and patient satisfaction with the final esthetic outcome. PMID:26633080

  16. Minimum 2-year outcome of cervical laminoplasty with deep extensor muscle-preserving approach: impact on cervical spine function and quality of life

    PubMed Central

    Abumi, Kuniyoshi; Ito, Manabu; Sudo, Hideki; Takahata, Masahiko; Ohshima, Shigeki; Hojo, Yoshihiro; Minami, Akio

    2009-01-01

    In this retrospective cohort study, two surgical methods of conventional open-door laminoplasty and deep extensor muscle-preserving laminoplasty were allocated for the treatment of cervical myelopathy, and were specifically compared in terms of axial pain, cervical spine function, and quality of life (QOL) with a minimum follow-up period of 2 years. Eighty-four patients were divided into two groups and received either a conventional open-door laminoplasty (CL group) or laminoplasty using a deep extensor muscle-preserving approach (MP group). The latter approach was performed by preserving multifidus and semispinalis cervicis attachments followed by open-door laminoplasty and re-suture of the bisected spinous processes at each decompression level. The average follow-up period was 38 months (25–53 months). The preoperative and follow-up evaluations included the original Japanese Orthopaedic Association (JOA) score, the new tentative JOA score including cervical spine function and QOL, and the visual analogue scale (VAS) of axial pain. Radiological analyses included cervical lordosis and flexion–extension range of motion (flex–ext ROM) (C2–7), and deep extensor muscle areas on MR axial images. The JOA recovery rates were statistically equivalent between two groups. The MP group demonstrated a statistically superior cervical spine function (84% vs 63%) and QOL (61% vs 45%) when compared to the CL group at final follow-up (P < 0.05). The average VAS scores at final follow-up were 2.3 and 4.9 in MP and CL groups (P < 0.05). The cervical lordosis and flex–ext ROM were statistically equivalent. The percent deep muscle area on MRI demonstrated a significant atrophy in CL group compared to that in MP group (56% vs 88%; P < 0.01). Laminoplasty employing the deep extensor muscle-preserving approach appeared to be effective in reducing the axial pain and deep muscle atrophy as well as improving cervical spine function and QOL when compared to conventional open

  17. Scaphoid morphology and clinical outcomes in scaphoid reconstructions.

    PubMed

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

    2012-03-01

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

  18. Outcome of percutaneous continuous drainage of psoas abscess: A clinically guided technique

    PubMed Central

    Dave, Bharat R; Kurupati, Ranganatha Babu; Shah, Dipak; Degulamadi, Devanand; Borgohain, Nitu; Krishnan, Ajay

    2014-01-01

    Background: Percutaneous aspiration of abscesses under ultrasonography (USG) and computer tomography (CT) scan has been well described. With recurrence rate reported as high as 66%. The open drainage and percutaneous continuous drainage (PCD) has reduced the recurrence rate. The disadvantage of PCD under CT is radiation hazard and problems of asepsis. Hence a technique of clinically guided percutaneous continuous drainage of the psoas abscess without real-time imaging overcomes these problems. We describe clinically guided PCD of psoas abscess and its outcome. Materials and Methods: Twenty-nine patients with dorsolumbar spondylodiscitis without gross neural deficit with psoas abscess of size >5 cm were selected for PCD. It was done as a day care procedure under local anesthesia. Sequentially, aspiration followed by guide pin-guided trocar and catheter insertion was done without image guidance. Culture sensitivity was done and chemotherapy initiated and catheter kept till the drainage was <10 ml for 48 hours. Outcome assessment was done with relief of pain, successful abscess drainage and ODI (Oswestry Disability Index) score at 2 years. Results: PCD was successful in all cases. Back and radicular pain improved in all cases. Average procedure time was 24.30 minutes, drain output was 234.40 ml, and the drainage duration was 7.90 days. One patient required surgical stabilisation due to progression of the spondylodiscitis resulting in instability inspite of successful drainage of abscess. Problems with the procedure were noticed in six patients. Multiple attempts (n = 2), persistent discharge (n = 1) for 2 weeks, blocked catheter (n = 2) and catheter pull out (n = 1) occurred with no effect on the outcome. The average ODI score improved from 62.47 to 5.51 at 2 years. Conclusions: Clinically guided PCD is an efficient, safe and easy procedure in drainage of psoas abscess. PMID:24600066

  19. Effects of Prednisolone on Disease Progression in Antiretroviral-Untreated HIV Infection: A 2-Year Randomized, Double-Blind Placebo-Controlled Clinical Trial

    PubMed Central

    Kasang, Christa; Kalluvya, Samuel; Majinge, Charles; Kongola, Gilbert; Mlewa, Mathias; Massawe, Irene; Kabyemera, Rogatus; Magambo, Kinanga; Ulmer, Albrecht; Klinker, Hartwig; Gschmack, Eva; Horn, Anne; Koutsilieri, Eleni; Preiser, Wolfgang; Hofmann, Daniela; Hain, Johannes; Müller, Andreas; Dölken, Lars; Weissbrich, Benedikt; Rethwilm, Axel; Stich, August; Scheller, Carsten

    2016-01-01

    Background HIV-disease progression correlates with immune activation. Here we investigated whether corticosteroid treatment can attenuate HIV disease progression in antiretroviral-untreated patients. Methods Double-blind, placebo-controlled randomized clinical trial including 326 HIV-patients in a resource-limited setting in Tanzania (clinicaltrials.gov NCT01299948). Inclusion criteria were a CD4 count above 300 cells/μl, the absence of AIDS-defining symptoms and an ART-naïve therapy status. Study participants received 5 mg prednisolone per day or placebo for 2 years. Primary endpoint was time to progression to an AIDS-defining condition or to a CD4-count below 200 cells/μl. Results No significant change in progression towards the primary endpoint was observed in the intent-to-treat (ITT) analysis (19 cases with prednisolone versus 28 cases with placebo, p = 0.1407). In a per-protocol (PP)-analysis, 13 versus 24 study participants progressed to the primary study endpoint (p = 0.0741). Secondary endpoints: Prednisolone-treatment decreased immune activation (sCD14, suPAR, CD38/HLA-DR/CD8+) and increased CD4-counts (+77.42 ± 5.70 cells/μl compared to -37.42 ± 10.77 cells/μl under placebo, p < 0.0001). Treatment with prednisolone was associated with a 3.2-fold increase in HIV viral load (p < 0.0001). In a post-hoc analysis stratifying for sex, females treated with prednisolone progressed significantly slower to the primary study endpoint than females treated with placebo (ITT-analysis: 11 versus 21 cases, p = 0.0567; PP-analysis: 5 versus 18 cases, p = 0.0051): No changes in disease progression were observed in men. Conclusions This study could not detect any significant effects of prednisolone on disease progression in antiretroviral-untreated HIV infection within the intent-to-treat population. However, significant effects were observed on CD4 counts, immune activation and HIV viral load. This study contributes to a better understanding of the role of immune

  20. Correlation of Reconstructed Scaphoid Morphology with Clinical Outcomes

    PubMed Central

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

    2015-01-01

    Background: Scaphoid malunion alters the carpal kinematics and impairs clinical outcome because of pain, weakness, restricted range of motion and predisposing the wrist joint to early osteoarthritis. The aim of this study was to evaluate the influence of the scaphoid morphological angles on clinical outcomes in patients with reconstructed scaphoid by non-vascularized bone graft. Methods: Seventeen male patients with the mean age of 31.7±3.7 years and mean non-union time of 31.5±14.7 months were enrolled in this retrospective study. Average follow up was 48.8±9.4 months. At the last follow-up, the patients were evaluated clinically for pain, wrist range of motion, grip strength, and wrist functional status. They were also evaluated radiologically by wrist radiographs and computerized tomography (CT). The overall clinical outcomes were evaluated by the Cooney wrist function score. The morphology of the reconstructed scaphoids was evaluated by the lateral intrascaphoid angle, antroposterior intrascaphoid angle, dorsal cortical angle, measuring the length (mm), and height-to-length ratio on CT scan. The radiological measurements were compared against the overall clinical outcomes. Results: There were 7 excellent, 7 good, 3 fair clinical results. The mean Cooney wrist function score was 83±4. The mean lateral intrascaphoid angle was 34.8±1.4 degrees, mean antroposterior intrascaphoid angle was 33.4±2.2 degrees, mean dorsal cortical angle was 158.3±4.8 degrees, mean scaphoid length was 22.1± 0.7 mm, and mean scaphoid height-to-length ratio was 0.74±0.04. There were no significant statistical correlations between the lateral intrascaphoid angles, antroposterior intrascaphoid angles, dorsal cortical angles, scaphoid lengths and scaphoid height-to-length ratios and Cooney wrist scores in the patients. Conclusion: In the current study, all the patients had some degree of scaphoid malunion; however, the radiological measurements of the reconstructed scaphoids did not

  1. A Retrospective Review of Outcomes of Dental Treatment Performed for Special Needs Patients under General Anaesthesia: 2-Year Follow-Up

    PubMed Central

    Mallineni, Sreekanth Kumar; Yiu, Cynthia Kar Yung

    2014-01-01

    Objective. The purpose of the study was to evaluate the follow-up pattern of special needs patients (SNP) treated under general anaesthesia (GA) and the failure rates of different treatment procedures and restorative materials. Study Design. The treatment records of the patients who received dental treatment under GA during 2005 to 2009 were reviewed. The duration of follow-up periods, the outcomes of different treatment procedures, and the quality of different restorative materials were recorded and evaluated. Statistics were used for the comparison (SPSS 20.0). Pearson's chi-square test and post hoc analysis were used to evaluate the attendance of postoperative appointments and the associations of failure rates of different treatment procedures and restorative materials. Cohen kappa statistics was used for intraexaminer reliability. Results. A total of 177 patients were included in the study. The attendance of postoperative appointments showed a gradual decrease from 96% to 36% within 24 months (P < 0.05). Restorative procedures had the highest failure rates among all treatment procedures (P < 0.05). Stainless steel crowns showed higher survival rates among different restorative materials (P < 0.05). Pulp treatment in primary molars has higher success rate than primary incisors and canines. Composite restorations placed in primary canines have low survival rates. The intraexaminer reliability was good (k = 0.94). Conclusion. The attendance for postoperative follow-up appointments declined within two years. Restorative treatment was less successful when compared to preventive and pulp treatments. Stainless steel crowns were more reliable restorations with higher survival rates and composite restorations were less durable. PMID:25610913

  2. Outcome Measures for Artificial Pancreas Clinical Trials: A Consensus Report.

    PubMed

    Maahs, David M; Buckingham, Bruce A; Castle, Jessica R; Cinar, Ali; Damiano, Edward R; Dassau, Eyal; DeVries, J Hans; Doyle, Francis J; Griffen, Steven C; Haidar, Ahmad; Heinemann, Lutz; Hovorka, Roman; Jones, Timothy W; Kollman, Craig; Kovatchev, Boris; Levy, Brian L; Nimri, Revital; O'Neal, David N; Philip, Moshe; Renard, Eric; Russell, Steven J; Weinzimer, Stuart A; Zisser, Howard; Lum, John W

    2016-07-01

    Research on and commercial development of the artificial pancreas (AP) continue to progress rapidly, and the AP promises to become a part of clinical care. In this report, members of the JDRF Artificial Pancreas Project Consortium in collaboration with the wider AP community 1) advocate for the use of continuous glucose monitoring glucose metrics as outcome measures in AP trials, in addition to HbA1c, and 2) identify a short set of basic, easily interpreted outcome measures to be reported in AP studies whenever feasible. Consensus on a broader range of measures remains challenging; therefore, reporting of additional metrics is encouraged as appropriate for individual AP studies or study groups. Greater consistency in reporting of basic outcome measures may facilitate the interpretation of study results by investigators, regulatory bodies, health care providers, payers, and patients themselves, thereby accelerating the widespread adoption of AP technology to improve the lives of people with type 1 diabetes. PMID:27330126

  3. 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

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

    PubMed

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

    2009-02-01

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

  5. Novel Outcome Measures for Clinical Trials in Cystic Fibrosis

    PubMed Central

    Tiddens, Harm AWM; Puderbach, Michael; Venegas, Jose G; Ratjen, Felix; Donaldson, Scott H; Davis, Stephanie D; Rowe, Steven M; Sagel, Scott D; Higgins, Mark; Waltz, David A

    2015-01-01

    Cystic fibrosis (CF) is a common inherited condition caused by mutations in the gene encoding the CF transmembrane regulator protein. With increased understanding of the molecular mechanisms underlying CF and the development of new therapies there comes the need to develop new outcome measures to assess the disease, its progression and response to treatment. As there are limitations to the current endpoints accepted for regulatory purposes, a workshop to discuss novel endpoints for clinical trials in CF was held in Anaheim, California in November 2011. The pros and cons of novel outcome measures with potential utility for evaluation of novel treatments in CF were critically evaluated. The highlights of the 2011 workshop and subsequent advances in technologies and techniques that could be used to inform the development of clinical trial endpoints are summarized in this review. Pediatr Pulmonol. © 2014 The Authors. Pediatric Pulmonology published by Wiley Periodicals, Inc. PMID:25641878

  6. Predicting outcome in clinically isolated syndrome using machine learning

    PubMed Central

    Wottschel, V.; Alexander, D.C.; Kwok, P.P.; Chard, D.T.; Stromillo, M.L.; De Stefano, N.; Thompson, A.J.; Miller, D.H.; Ciccarelli, O.

    2014-01-01

    We aim to determine if machine learning techniques, such as support vector machines (SVMs), can predict the occurrence of a second clinical attack, which leads to the diagnosis of clinically-definite Multiple Sclerosis (CDMS) in patients with a clinically isolated syndrome (CIS), on the basis of single patient's lesion features and clinical/demographic characteristics. Seventy-four patients at onset of CIS were scanned and clinically reviewed after one and three years. CDMS was used as the gold standard against which SVM classification accuracy was tested. Radiological features related to lesional characteristics on conventional MRI were defined a priori and used in combination with clinical/demographic features in an SVM. Forward recursive feature elimination with 100 bootstraps and a leave-one-out cross-validation was used to find the most predictive feature combinations. 30 % and 44 % of patients developed CDMS within one and three years, respectively. The SVMs correctly predicted the presence (or the absence) of CDMS in 71.4 % of patients (sensitivity/specificity: 77 %/66 %) at 1 year, and in 68 % (60 %/76 %) at 3 years on average over all bootstraps. Combinations of features consistently gave a higher accuracy in predicting outcome than any single feature. Machine-learning-based classifications can be used to provide an “individualised” prediction of conversion to MS from subjects' baseline scans and clinical characteristics, with potential to be incorporated into routine clinical practice. PMID:25610791

  7. 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

  8. The Targon FN System for the Management of Intracapsular Neck of Femur Fractures: Minimum 2-Year Experience and Outcome in an Independent Hospital

    PubMed Central

    Tissingh, Elizabeth; Wartenberg, Kakra; Aggarwal, Saurabh; Ismail, Fikry; Orakwe, Sam; Khan, Farid

    2015-01-01

    Background The Targon FN implant was developed in 2007 to treat intracapsular neck of femur fractures. Early results from the design centre have shown good results in terms of fracture complications. We wished to see if these results can be reproduced in an independent institution. Methods The records of consecutive patients, treated with this implant between 2008 and 2011 at Queen Elizabeth Hospital, were identified and collected for this study. Operations were performed by all grades of surgeons under supervision as appropriate. These patients went on to have both clinical and radiological assessment for fracture healing and function. Results Fifty-one patients were identified with 43 patients available for final follow-up. The average age was 66 years with a minimum follow-up of 24 months. A non-union rate of 0% in the undisplaced fracture group and 1 in 12 (8%) in the displaced fracture group was observed. An avascular necrosis rate of 6% and 8% was observed for undisplaced and displaced fracture types, respectively. No significant change in premorbid to postoperative ambulation was observed and there was no wound complication. Conclusions Our study shows similar results with those of the design centre and which are superior to those currently found in the literature for the more traditional fixation methods. It also shows that the promising results with this new implant as seen from the design institutions can be reproduced by all cadres of surgeons in non-specialist practice. PMID:25729515

  9. Clinical characteristics and outcomes of neonatal pertussis: a comparative study.

    PubMed

    Castagnini, Luis A; Munoz, Flor M

    2010-03-01

    We describe the features and outcomes of neonatal pertussis and compare these with neonates with non-pertussis acute respiratory illness from July 2000 through December 2007. Patients with pertussis had a more severe course of disease as evidenced by the clinical presentation, length of hospitalization, and oxygen requirement. Clinicians should have a high index of suspicion so that appropriate supportive care can be initiated promptly. PMID:20056236

  10. Clinical Outcomes of Metabolic Surgery: Microvascular and Macrovascular Complications.

    PubMed

    Adams, Ted D; Arterburn, David E; Nathan, David M; Eckel, Robert H

    2016-06-01

    Understanding of the long-term clinical outcomes associated with bariatric surgery has recently been advanced. Research related to the sequelae of diabetes-in particular, long-term microvascular and macrovascular complications-in patients who undergo weight-loss surgery is imperative to this pursuit. While numerous randomized control trials have assessed glucose control with bariatric surgery compared with intensive medical therapy, bariatric surgery outcome data relating to microvascular and macrovascular complications have been limited to observational studies and nonrandomized clinical trials. As a result, whether bariatric surgery is associated with a long-term reduction in microvascular and macrovascular complications when compared with current intensive glycemic control therapy cannot be determined because the evidence is insufficient. However, the consistent salutary effects of bariatric surgery on diabetes remission and glycemic improvement support the opportunity (and need) to conduct high-quality studies of bariatric surgery versus intensive glucose control. This review provides relevant background information related to the treatment of diabetes, hyperglycemia, and long-term complications; reports clinical findings (to date) with bariatric surgery; and identifies ongoing research focusing on long-term vascular outcomes associated with bariatric surgery. PMID:27222549

  11. Candida Virulence Properties and Adverse Clinical Outcomes in Neonatal Candidiasis

    PubMed Central

    Bliss, Joseph M.; Wong, Angela Y.; Bhak, Grace; Laforce-Nesbitt, Sonia S.; Taylor, Sarah; Tan, Sylvia; Stoll, Barbara J.; Higgins, Rosemary D.; Shankaran, Seetha; Benjamin, Daniel K.

    2012-01-01

    Objective To determine if premature infants with invasive Candida infection caused by strains with increased virulence properties have worse clinical outcomes than those infected with less virulent strains. Study design Clinical isolates were studied from 2 populations; premature infants colonized with Candida (commensal, n=27), and those with invasive candidiasis (n=81). Individual isolates of C. albicans and C. parapsilosis were tested for virulence in each of 3 assays: phenotypic switching, adhesion, and cytotoxicity. Invasive isolates were considered to have enhanced virulence if they measured more than 1 SD above the mean for the commensal isolates in at least 1 assay. Outcomes of patients with invasive isolates with enhanced virulence were compared with those with invasive isolates lacking enhanced virulence characteristics. Results 61% of invasive isolates of C. albicans and 42% of invasive isolates of C. parapsilosis had enhanced virulence. All C. albicans cerebrospinal fluid (CSF) isolates (n=6) and 90% of urine isolates (n=10) had enhanced virulence, compared with 48% of blood isolates (n=40). Infants with more virulent isolates were younger at the time of positive culture and had higher serum creatinine. Conclusions Individual isolates of Candida species vary in their virulence properties. Strains with higher virulence are associated with certain clinical outcomes. PMID:22504098

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

    PubMed

    Annapureddy, N; Devilliers, H; Jolly, M

    2016-09-01

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

  13. Clinical outcome of collateral ligament injuries of the tarsus

    PubMed Central

    Lamb, Lauren; Zubrod, Chad; Hague, Brent; Brakenhoff, Jeff; Major, Michael

    2012-01-01

    The significance of collateral ligament desmitis of the tarsocrural joint is often clinically underestimated, because it is an uncommon injury with a guarded prognosis for athletic soundness. The objective of this study was to describe the clinical presentation, treatment, and outcome of 12 horses with collateral ligament desmitis, along with tarsocrural joint synovitis secondary to hemarthrosis. Criteria for inclusion in this study included clinical signs of tarsocrural joint synovitis and sonographic evidence of collateral ligament desmitis. This retrospective study evaluated horses over an 8-year period. Median follow-up after treatment was 5.5 years. Four horses in the study returned to their previous level of performance, 6 horses remained lame due to pain in the tarsus, 1 was euthanized, and 1 is in convalescence. This study highlights the importance of collateral ligament desmitis, and emphasizes the need for early, aggressive treatment to prevent the development of osteoarthritis. PMID:23115364

  14. High-Dose Rate Brachytherapy Using Inverse Planning Simulated Annealing for Locoregionally Advanced Cervical Cancer: A Clinical Report With 2-Year Follow-Up

    SciTech Connect

    Kim, Daniel H.; Wang-Chesebro, Alice; Weinberg, Vivian; Pouliot, Jean; Chen, Lee-May; Speight, Joycelyn; Littell, Ramey; Hsu, I.-Chow

    2009-12-01

    Purpose: We present clinical outcomes of image-guided brachytherapy using inverse planning simulated annealing (IPSA) planned high-dose rate (HDR) brachytherapy boost for locoregionally advanced cervical cancer. Methods and Materials: From February 2004 through December 2006, 51 patients were treated at the University of California, San Francisco with HDR brachytherapy boost as part of definitive radiation for International Federation of Gynecology and Obstetrics Stage IB1 to Stage IVA cervical cancer. Of the patients, 46 received concurrent chemotherapy, 43 with cisplatin alone and 3 with cisplatin/5-fluorouracil. All patients had IPSA-planned HDR brachytherapy boost after whole-pelvis external radiation to a total tumor dose of 85 Gy or greater (for alpha/beta = 10). Toxicities are reported according to National Cancer Institute CTCAE v3.0 (Common Terminology Criteria for Adverse Events version 3.0) guidelines. Results: At a median follow-up of 24.3 months, there were no toxicities of Grade 4 or greater and the frequencies of Grade 3 acute and late toxicities were 4% and 2%, respectively. The proportion of patients having Grade 1 or 2 gastrointestinal and genitourinary acute toxicities was 48% and 52%, respectively. Low-grade late toxicities included Grade 1 or 2 vaginal, gastrointestinal, and hormonal toxicities in 31%, 18%, and 4% of patients, respectively. During the follow-up period, local recurrence developed in 2 patients, regional recurrence developed in 2, and new distant metastases developed in 15. The rates of locoregional control of disease and overall survival at 24 months were 91% and 86%, respectively. Conclusions: Definitive radiation by use of inverse planned HDR brachytherapy boost for locoregionally advanced cervical cancer is well tolerated and achieves excellent local control of disease.

  15. ADCOMS: a composite clinical outcome for prodromal Alzheimer's disease trials

    PubMed Central

    Wang, Jinping; Logovinsky, Veronika; Hendrix, Suzanne B; Stanworth, Stephanie H; Perdomo, Carlos; Xu, Lu; Dhadda, Shobha; Do, Ira; Rabe, Martin; Luthman, Johan; Cummings, Jeffrey; Satlin, Andrew

    2016-01-01

    Background Development of new therapies for Alzheimer's disease (AD) is increasingly focused on more mildly affected populations, and requires new assessment and outcome strategies. Patients in early stages of AD have mild cognitive decline and no, or limited, functional impairment. To respond to these assessment challenges, we developed a measurement approach based on established scale items that exhibited change in previous amnestic Mild Cognitive Impairment (aMCI) trials. Methods Partial least squares regression with a longitudinal clinical decline model identified items from commonly used clinical scales with the highest combined sensitivity to change over time in aMCI and weighted these items according to their relative contribution to detecting clinical progression in patients’ early stages of AD. The resultant AD Composite Score (ADCOMS) was assessed for its ability to detect treatment effect in aMCI/prodromal AD (pAD) clinical trial populations. Results ADCOMS consists of 4 Alzheimer's Disease Assessment Scale–cognitive subscale items, 2 Mini-Mental State Examination items, and all 6 Clinical Dementia Rating—Sum of Boxes items. ADCOMS demonstrated improved sensitivity to clinical decline over individual scales in pAD, aMCI and in mild AD dementia. ADCOMS also detected treatment effects associated with the use of cholinesterase inhibitors in these populations. Improved sensitivity predicts smaller sample size requirements when ADCOMS is used in early AD trials. Conclusions ADCOMS is proposed as new standard outcome for pAD and mild AD dementia trials, and is progressing in a CAMD-sponsored qualification process for use in registration trials of pAD. PMID:27010616

  16. Developmental milestones record - 2 years

    MedlinePlus

    Growth milestones for children - 2 years; Normal childhood growth milestones - 2 years; Childhood growth milestones - 2 years ... a cause for concern if not seen by 2 years.) Can run with better coordination . (May still ...

  17. Developmental milestones record - 2 years

    MedlinePlus

    Growth milestones for children - 2 years; Normal childhood growth milestones - 2 years; Childhood growth milestones - 2 years ... cause for concern if not seen by 2 years.) Can run with better coordination. (May still have ...

  18. Do clinical outcome measures assess consumer-defined recovery?

    PubMed

    Andresen, Retta; Caputi, Peter; Oades, Lindsay G

    2010-05-30

    There is an international call for mental health services to become recovery-oriented, and also to use evidence-based practices. Addressing this call requires recovery-oriented measurement of outcomes and service evaluation. Mental health consumers view recovery as leading as meaningful life, and have criticised traditional clinical measures for being too disability-oriented. This study compares three measures of consumer-defined recovery from enduring mental illness: the Recovery Assessment Scale, the Mental Health Recovery Measure and the Self-Identified Stage of Recovery, with four conventional clinical measures. Correlational analyses supported the convergent validity of the recovery measures, although certain subscales were unrelated to each other. More importantly, little relationship was found between consumer-defined recovery and the clinical measures. Analyses of variance revealed that scores on the recovery measures increased across self-identified stage of recovery, but scores on most clinical measures did not improve consistently across stage of recovery. The findings demonstrate the qualitative difference between the two types of measures, supporting the claim by consumers that clinical measures do not assess important aspects of recovery. There is a need for further research and refinement of recovery measurement, including assessment of stages of recovery, with the aim of including such measures as an adjunct in routine clinical assessment, service evaluation and research. PMID:20227768

  19. Breast Cancer EDGE Task Force Outcomes: Clinical Measures of Pain

    PubMed Central

    Harrington, Shana; Gilchrist, Laura; Sander, Antoinette

    2014-01-01

    Background Pain is one of the most commonly reported impairments after breast cancer treatment affecting anywhere from 16-73% of breast cancer survivors Despite the high reported incidence of pain from cancer and its treatments, the ability to evaluate cancer pain continues to be difficult due to the complexity of the disease and the subjective experience of pain. The Oncology Section Breast Cancer EDGE Task Force was created to evaluate the evidence behind clinical outcome measures of pain in women diagnosed with breast cancer. Methods The authors systematically reviewed the literature for pain outcome measures published in the research involving women diagnosed with breast cancer. The goal was to examine the reported psychometric properties that are reported in the literature in order to determine clinical utility. Results Visual Analog Scale, Numeric Rating Scale, Pressure Pain Threshold, McGill Pain Questionnaire, McGill Pain Questionnaire – Short Form, Brief Pain Inventory and Brief Pain Inventory – Short Form were highly recommended by the Task Force. The Task Force was unable to recommend two measures for use in the breast cancer population at the present time. Conclusions A variety of outcome measures were used to measure pain in women diagnosed with breast cancer. When assessing pain in women with breast cancer, researchers and clinicians need to determine whether a unidimensional or multidimensional tool is most appropriate as well as whether the tool has strong psychometric properties. PMID:25346950

  20. Renal function trajectory over time and adverse clinical outcomes.

    PubMed

    Sohel, Badrul Munir; Rumana, Nahid; Ohsawa, Masaki; Turin, Tanvir Chowdhury; Kelly, Martina Ann; Al Mamun, Mohammad

    2016-06-01

    The growing burden of chronic kidney disease (CKD), with its associated morbidity and mortality, is recognized as a major public health problem globally and causing substantial load on health care systems. The current framework for the definition and staging of CKD, based on eGFR levels or presence of kidney damage, is useful for clinical classification of patients, but identifies a huge number of people as having CKD which is too many to target for intervention. The ability to identify a subset of patients, at high risk for adverse outcomes, would be useful to inform clinical management. The current staging system applies static definitions of kidney function that fail to capture the dynamic nature of the kidney disease over time. Now-a-days, it is possible to capture multiple measurements of different laboratory test results for an individual including eGFR values. A new possibility for identifying individuals at higher risk of adverse outcomes is being explored through assessment and consideration of the rate of change in kidney function over time, and this approach will be feasible in the current context of digitalization of health record keeping system. On the basis of the existing evidence, this paper summarizes important findings that support the concept of dynamic changes in kidney function over time, and discusses how the magnitude of these changes affect the future adverse outcomes of kidney disease, particularly the End Stage Renal Disease (ESRD), CVD and mortality. PMID:26728745

  1. Adaptive Radiotherapy for Head-and-Neck Cancer: Initial Clinical Outcomes From a Prospective Trial

    SciTech Connect

    Schwartz, David L.; Garden, Adam S.; Thomas, Jimmy; Chen Yipei; Zhang Yongbin; Lewin, Jan; Chambers, Mark S.; Dong, Lei

    2012-07-01

    Purpose: To present pilot toxicity and survival outcomes for a prospective trial investigating adaptive radiotherapy (ART) for oropharyngeal squamous cell carcinoma. Methods and Materials: A total of 24 patients were enrolled in an institutional review board-approved clinical trial; data for 22 of these patients were analyzed. Daily CT-guided setup and deformable image registration permitted serial mapping of clinical target volumes and avoidance structures for ART planning. Primary site was base of tongue in 15 patients, tonsil in 6 patient, and glossopharyngeal sulcus in 1 patient. Twenty patients (91%) had American Joint Committee on Cancer (AJCC) Stage IV disease. T stage distribution was 2 T1, 12 T2, 3 T3, 5 T4. N stage distribution was 1 N0, 2 N1, 5 N2a, 12 N2b, and 2 N2c. Of the patients, 21 (95%) received systemic therapy. Results: With a 31-month median follow-up (range, 13-45 months), there has been no primary site failure and 1 nodal relapse, yielding 100% local and 95% regional disease control at 2 years. Baseline tumor size correlated with absolute volumetric treatment response (p = 0.018). Parotid volumetric change correlated with duration of feeding tube placement (p = 0.025). Acute toxicity was comparable to that observed with conventional intensity-modulated radiotherapy (IMRT). Chronic toxicity and functional outcomes beyond 1 year were tabulated. Conclusion: This is the first prospective evaluation of morbidity and survival outcomes in patients with locally advanced head-and-neck cancer treated with automated adaptive replanning. ART can provide dosimetric benefit with only one or two mid-treatment replanning events. Our preliminary clinical outcomes document functional recovery and preservation of disease control at 1-year follow-up and beyond.

  2. RASCH ANALYSIS OF CLINICAL OUTCOME MEASURES IN SPINAL MUSCULAR ATROPHY

    PubMed Central

    CANO, STEFAN J.; MAYHEW, ANNA; GLANZMAN, ALLAN M.; KROSSCHELL, KRISTIN J.; SWOBODA, KATHRYN J.; MAIN, MARION; STEFFENSEN, BIRGIT F.; BÉRARD, CAROLE; GIRARDOT, FRANÇOISE; PAYAN, CHRISTINE A.M.; MERCURI, EUGENIO; MAZZONE, ELENA; ELSHEIKH, BAKRI; FLORENCE, JULAINE; HYNAN, LINDA S.; IANNACCONE, SUSAN T.; NELSON, LESLIE L.; PANDYA, SHREE; ROSE, MICHAEL; SCOTT, CHARLES; SADJADI, REZA; YORE, MACKENSIE A.; JOYCE, CYNTHIA; KISSEL, JOHN T.

    2015-01-01

    Introduction Trial design for SMA depends on meaningful rating scales to assess outcomes. In this study Rasch methodology was applied to 9 motor scales in spinal muscular atrophy (SMA). Methods Data from all 3 SMA types were provided by research groups for 9 commonly used scales. Rasch methodology assessed the ordering of response option thresholds, tests of fit, spread of item locations, residual correlations, and person separation index. Results Each scale had good reliability. However, several issues impacting scale validity were identified, including the extent that items defined clinically meaningful constructs and how well each scale measured performance across the SMA spectrum. Conclusions The sensitivity and potential utility of each SMA scale as outcome measures for trials could be improved by establishing clear definitions of what is measured, reconsidering items that misfit and items whose response categories have reversed thresholds, and adding new items at the extremes of scale ranges. PMID:23836324

  3. Clinical Outcomes Associated with Home Mechanical Ventilation: A Systematic Review.

    PubMed

    MacIntyre, Erika J; Asadi, Leyla; Mckim, Doug A; Bagshaw, Sean M

    2016-01-01

    Background. The prevalence of patients supported with home mechanical ventilation (HMV) for chronic respiratory failure has increased. However, the clinical outcomes associated with HMV are largely unknown. Methods. We performed a systematic review of studies evaluating patients receiving HMV for indications other than obstructive lung disease, reporting at least one clinically relevant outcome including health-related quality of life (HRQL) measured by validated tools; hospitalization requirements; caregiver burden; and health service utilization. We searched MEDLINE, EMBASE, CINAHL, the Cochrane library, clinical trial registries, proceedings from selected scientific meetings, and bibliographies of retrieved citations. Results. We included 1 randomized control trial (RCT) and 25 observational studies of mixed methodological quality involving 4425 patients; neuromuscular disorders (NMD) (n = 1687); restrictive thoracic diseases (RTD) (n = 481); obesity hypoventilation syndrome (OHS) (n = 293); and others (n = 748). HRQL was generally described as good for HMV users. Mental rather than physical HRQL domains were rated higher, particularly where physical assessment was limited. Hospitalization rates and days in hospital appear to decrease with implementation of HMV. Caregiver burden associated with HMV was generally high; however, it is poorly described. Conclusion. HRQL and need for hospitalization may improve after establishment of HMV. These inferences are based on relatively few studies of marked heterogeneity and variable quality. PMID:27445559

  4. Clinical Outcomes Associated with Home Mechanical Ventilation: A Systematic Review

    PubMed Central

    MacIntyre, Erika J.; Asadi, Leyla; Mckim, Doug A.; Bagshaw, Sean M.

    2016-01-01

    Background. The prevalence of patients supported with home mechanical ventilation (HMV) for chronic respiratory failure has increased. However, the clinical outcomes associated with HMV are largely unknown. Methods. We performed a systematic review of studies evaluating patients receiving HMV for indications other than obstructive lung disease, reporting at least one clinically relevant outcome including health-related quality of life (HRQL) measured by validated tools; hospitalization requirements; caregiver burden; and health service utilization. We searched MEDLINE, EMBASE, CINAHL, the Cochrane library, clinical trial registries, proceedings from selected scientific meetings, and bibliographies of retrieved citations. Results. We included 1 randomized control trial (RCT) and 25 observational studies of mixed methodological quality involving 4425 patients; neuromuscular disorders (NMD) (n = 1687); restrictive thoracic diseases (RTD) (n = 481); obesity hypoventilation syndrome (OHS) (n = 293); and others (n = 748). HRQL was generally described as good for HMV users. Mental rather than physical HRQL domains were rated higher, particularly where physical assessment was limited. Hospitalization rates and days in hospital appear to decrease with implementation of HMV. Caregiver burden associated with HMV was generally high; however, it is poorly described. Conclusion. HRQL and need for hospitalization may improve after establishment of HMV. These inferences are based on relatively few studies of marked heterogeneity and variable quality. PMID:27445559

  5. Percutaneous Endoscopic Lumbar Foraminotomy: An Advanced Surgical Technique and Clinical Outcomes

    PubMed Central

    Oh, Hyun-Kyong; Kim, Ho; Lee, Sang-Ho; Lee, Haeng-Nam

    2014-01-01

    BACKGROUND: Although several authors have reported the use of endoscopic techniques to treat lumbar foraminal stenosis, the practical application of these techniques has been limited to soft disc herniation. OBJECTIVE: To describe the details of the percutaneous endoscopic lumbar foraminotomy (ELF) technique for bony foraminal stenosis and to demonstrate the clinical outcomes. METHODS: Two years of prospective data were collected from 33 consecutive patients with lumbar foraminal stenosis who underwent ELF. The surgical outcomes were assessed using the visual analog scale, Oswestry Disability Index, and modified MacNab criteria. The procedure begins at the safer extraforaminal zone rather than the riskier intraforaminal zone. Then, a full-scale foraminal decompression can be performed using a burr and punches under endoscopic control. RESULTS: The mean age of the 18 female and 15 male patients was 64.2 years. The mean visual analog scale score for leg pain improved from 8.36 at baseline to 3.36 at 6 weeks, 2.03 at 1 year, and 1.97 at 2 years post-surgery (P < .001). The mean Oswestry Disability Index improved from 65.8 at baseline to 31.6 at 6 weeks, 19.7 at 1 year, and 19.3 at 2 years post-surgery (P < .001). Based on the modified MacNab criteria, excellent or good results were obtained in 81.8% of the patients, and symptomatic improvements were obtained in 93.9%. CONCLUSION: Percutaneous ELF under local anesthesia could be an efficacious surgical procedure for the treatment of foraminal stenosis. This procedure may offer safe and reproducible results, especially for elderly or medically compromised patients. ABBREVIATIONS: ELF,endoscopic lumbar foraminotomy ODI, Oswestry Disability Index VAS, visual analog scale PMID:24691470

  6. Clinical characteristics and outcome of cancer diagnosed during pregnancy

    PubMed Central

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

    2016-01-01

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

  7. Clinical Outcomes Following Arthroscopic Micro Fracture of the Hip

    PubMed Central

    Begly, John P.; Ryan, Michael K.; Capogna, Brian; Youm, Thomas

    2016-01-01

    Objectives: Objective and clinical results of microfracture for treatment of chondral defects of the knee is well documented, yet outcomes for microfracture of the hip have not been extensively studied. Recently, several studies demonstrated clinical improvements in patients treated with microfracture of the hip. The purpose of this study is to examine clinical outcomes and survivorship in patients who underwent microfracture during arthroscopic hip surgery. Methods: A retrospective analysis of a prospectively collected database was performed. Thirty-eight patients with a mean age of 41 (range, 17-64) who underwent microfracture during arthroscopic hip surgery by a single surgeon (senior author) were identified. Demographic data, diagnosis, and details regarding operative procedures were collected. All patients were indicated for hip arthroscopy based on standard pre-operative examination as well as routine and advanced imaging. Baseline pre-operative modified Harris Hip Scores (mHHS) and Non-Arthritic Hip Scores (NAHS) were compared to mHHS and NAHS at two-year follow-up. Additionally, survivorship data was assessed to determine failure, defined as any subsequent revision arthroscopic surgery and/or hip arthroplasty of the same hip. Results: Thirty-four of the 38 (89.5%) patients were available for two-year clinical follow-up. Baseline mean mHHHS and NAHS for all patients improved from 50.6 (+/- 12.7) and 46.9 (+/-12.8) to 84.7 (+/- 12.5) and 85.6 (+/- 11.2) respectively. Both improvements were statistically significant (p < 0.05). Eight patients (23.5%) met failure criteria and underwent additional surgery at an average of 23.9 months. Two patients (5.8%) underwent revision arthroscopic surgery, and six patients (17.7%) underwent hip arthroplasty. Conclusion: Significant improvements in clinical outcomes are seen at two-year follow-up after microfracture treatment of chondral lesions of the hip. Despite overall success, failure rates are relatively high. As with

  8. 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

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

    PubMed Central

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

    2016-01-01

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

  10. A clinical risk score of myocardial fibrosis predicts adverse outcomes in aortic stenosis

    PubMed Central

    Chin, Calvin W.L.; Messika-Zeitoun, David; Shah, Anoop S.V.; Lefevre, Guillaume; Bailleul, Sophie; Yeung, Emily N.W.; Koo, Maria; Mirsadraee, Saeed; Mathieu, Tiffany; Semple, Scott I.; Mills, Nicholas L.; Vahanian, Alec; Newby, David E.; Dweck, Marc R.

    2016-01-01

    Aims Midwall myocardial fibrosis on cardiovascular magnetic resonance (CMR) is a marker of early ventricular decompensation and adverse outcomes in aortic stenosis (AS). We aimed to develop and validate a novel clinical score using variables associated with midwall fibrosis. Methods and results One hundred forty-seven patients (peak aortic velocity (Vmax) 3.9 [3.2,4.4] m/s) underwent CMR to determine midwall fibrosis (CMR cohort). Routine clinical variables that demonstrated significant association with midwall fibrosis were included in a multivariate logistic score. We validated the prognostic value of the score in two separate outcome cohorts of asymptomatic patients (internal: n = 127, follow-up 10.3 [5.7,11.2] years; external: n = 289, follow-up 2.6 [1.6,4.5] years). Primary outcome was a composite of AS-related events (cardiovascular death, heart failure, and new angina, dyspnoea, or syncope). The final score consisted of age, sex, Vmax, high-sensitivity troponin I concentration, and electrocardiographic strain pattern [c-statistic 0.85 (95% confidence interval 0.78–0.91), P < 0.001; Hosmer–Lemeshow χ2 = 7.33, P = 0.50]. Patients in the outcome cohorts were classified according to the sensitivity and specificity of this score (both at 98%): low risk (probability score <7%), intermediate risk (7–57%), and high risk (>57%). In the internal outcome cohort, AS-related event rates were >10-fold higher in high-risk patients compared with those at low risk (23.9 vs. 2.1 events/100 patient-years, respectively; log rank P < 0.001). Similar findings were observed in the external outcome cohort (31.6 vs. 4.6 events/100 patient-years, respectively; log rank P < 0.001). Conclusion We propose a clinical score that predicts adverse outcomes in asymptomatic AS patients and potentially identifies high-risk patients who may benefit from early valve replacement. PMID:26491110

  11. [Clinical Outcomes of Cardiovascular Surgery in Jehovah's Witness Patients].

    PubMed

    Mukaihara, Kosuke; Yamashita, Masafumi; Toyohira, Hitoshi; Yotsumoto, Goichi; Fukumoto, Yoshihiro; Ueno, Takayuki; Matsumoto, Kazuhisa; Moriyama, Yukinori; Imoto, Yutaka

    2016-03-01

    Cardiovascular surgery in Jehovah's Witness is challenging for surgeons on the ground that they refuse blood transfusion. We report 11 cases of cardiovascular surgery. All of the patients underwent elective surgery with cardiopulmonary bypass. Two cases underwent minimally invasive procedures. The mean preoperative hemoglobin level was 13.0 g/dl, and hematopoietic medicines were preoperatively administrated in 4 patients. Although 10 patients recovered satisfactory without blood transfusion, 1 surgical case was lost due to uncontrollable postoperative bleeding. The clinical outcomes of the Jehovah's Witness patients are considered to be satisfactory. However, careful indication is recommended in high risk cases. PMID:27075280

  12. Clinical outcomes of endovascularly managed iatrogenic renal hemorrhages

    PubMed Central

    Chiramel, George Koshy; Keshava, Shyamkumar Nidugala; Moses, Vinu; Kekre, Nitin; Tamilarasi, V; Devasia, Anthony

    2015-01-01

    Objective: To evaluate the effectiveness of endovascular management in iatrogenic renal injuries with regard to clinical status on follow-up and requirements for repeat angiography and embolization. Materials and Methods: This retrospective study included patients who were referred for endovascular management of significant hemorrhage following an iatrogenic injury. Data was recorded from the Picture Archiving and Communication system (PACS) and electronic medical records. The site and type of iatrogenic injury, imaging findings, treatment, angiography findings, embolization performed, clinical status on follow-up, and requirement for repeat embolization were recorded. The outcomes were clinical resolution, nephrectomy, or death. Clinical findings were recorded on follow-up visits to the clinic. Statistical analysis was performed using descriptive statistics. Results: Seventy patients were included in this study between January 2000 and June 2012. A bleeding lesion (a pseudoaneurysm or arteriovenous fistula) was detected during the first angiogram in 55 patients (78.6%) and was selectively embolized. Fifteen required a second angiography as there was no clinical improvement and five required a third angiography. Overall, 66 patients (94.3%) showed complete resolution and 4 patients (5.7%) died. Three patients (4.3%) underwent nephrectomy for clinical stabilization even after embolization. There were no major complications. The two minor complications resolved spontaneously. Conclusions: Angiography and embolization is the treatment of choice in iatrogenic renal hemorrhage. Upto 20% of initial angiograms may not reveal the bleed and repeat angiography is required to identify a recurrent or unidentified bleed. The presence of multiple punctate bleeders on angiography suggests an enlarging subcapsular hematoma and requires preoperative embolization and nephrectomy. PMID:26752819

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

    PubMed Central

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

    2009-01-01

    This non-experimental study used Mixed-Effects Regression Models (MRMs) to examine relations among supervisor adherence to a clinical supervision protocol, therapist adherence, and changes in the behavior and functioning of youth with serious antisocial behavior treated with an empirically supported treatment (i.e., Multisystemic Therapy), one-year post treatment. Participants were 1979 youth and families treated by 429 clinicians across 45 provider organizations in North America. Four dimensions of clinical supervision were examined. MRM results showed one dimension, supervisor focus on adherence to treatment principles, predicted greater therapist adherence. Two supervision dimensions, adherence to the structure and process of supervision, and focus on clinician development, predicted changes in youth behavior. Conditions required to test hypothesized mediation by therapist adherence of supervisor adherence effects on youth outcomes were not met, and direct effects of each were observed in models including both supervisor and therapist adherence. PMID:19485583

  14. Correlation of Fluconazole MICs with Clinical Outcome in Cryptococcal Infection

    PubMed Central

    Aller, A. I.; Martin-Mazuelos, E.; Lozano, F.; Gomez-Mateos, J.; Steele-Moore, L.; Holloway, W. J.; Gutiérrez, M. J.; Recio, F. J.; Espinel-Ingroff, A.

    2000-01-01

    We have correlated the in vitro results of testing the susceptibility of Cryptococcus neoformans to fluconazole with the clinical outcome after fluconazole maintenance therapy in patients with AIDS-associated cryptococcal disease. A total of 28 isolates of C. neoformans from 25 patients (24 AIDS patients) were tested. The MICs were determined by the broth microdilution technique by following the modified guidelines described in National Committee for Clinical Standards (NCCLS) document M27-A, e.g., use of yeast nitrogen base medium and a final inoculum of 104 CFU/ml. The fluconazole MIC at which 50% of isolates are inhibited (MIC50) and MIC90, obtained spectrophotometrically after 48 h of incubation, were 4 and 16 μg/ml, respectively. Of the 25 patients studied, 4 died of active cryptococcal disease and 2 died of other causes. Therapeutic failure was observed in five patients who were infected with isolates for which fluconazole MICs were ≥16 μg/ml. Four of these patients had previously had oropharyngeal candidiasis (OPC); three had previously had episodes of cryptococcal infection, and all five treatment failure patients had high cryptococcal antigen titers in either serum or cerebrospinal fluid (titers, >1:4,000). Although 14 of the 18 patients who responded to fluconazole therapy had previously had OPC infections, they each had only a single episode of cryptococcal infection. It appears that the clinical outcome after fluconazole maintenance therapy may be better when the infecting C. neoformans strain is inhibited by lower concentrations of fluconazole for eradication (MICs, <16 μg/ml) than when the patients are infected with strains that require higher fluconazole concentrations (MICs, ≥16 μg/ml). These findings also suggest that the MICs determined by the modified NCCLS microdilution method can be potential predictors of the clinical response to fluconazole therapy and may aid in the identification of patients who will not respond to fluconazole

  15. CLINICAL OUTCOME AFTER INFECTED TOTAL KNEE AND TOTAL HIP ARTHROPLASTY

    PubMed Central

    Mittag, Falk; Leichtle, Carmen Ina; Schlumberger, Michael; Leichtle, Ulf Gunther; Wünschel, Markus

    2016-01-01

    ABSTRACT Objective: Infection after total hip (THA) and knee arthroplasty (TKA) is a serious complication which typically leads to a long lasting and intensive surgical and medicamentous treatment. The aim of this study was to identify factors that influence outcome after revision surgery caused by prosthetic infection. Methods: We retrospectively analyzed 64 patients who had revision surgery between 1989 and 2009 due to periprosthetic infection. We examined a total of 69 joints (TKA: 36%, THA: 64%), follow-up 5.1 years (0.5-21 years) after the initial surgical intervention. The mean patient age at time of surgery was 67 years old (43-79 years old). Clinical data and scores including the Western Ontario and McMaster Universities (WOMAC)-Index, the Harris Hip Score (HHS) and the Hospital for Special Surgery Score (HSS) were surveyed. Results: There was no difference in clinical scores regarding treatment between a single and a multiple stage treatment regime. Infections with multiple microorganisms and Enterococcus spp. lead to a significantly higher number of interventions. Using a modified Tsukayama system we classified 24% as type I, 34% type II and 42% type III- infections, with no differences in clinical outcome. Overweight patients had a significantly lower HHS and WOMAC-score. Immunosuppression leads to a worse WOMAC and HSS-Score. An increased number of procedures was associated to a limping gait. Conclusion: Thorough surgical technique leads to good clinical results independent of infection-type and treatment philosophy. Level of Evidence III, Case Control Study. PMID:26997914

  16. Congenital Aural Stenosis: Clinical Features and Long-term Outcomes.

    PubMed

    Li, Chen-Long; Chen, Ying; Chen, Yong-Zheng; Fu, Yao-Yao; Zhang, Tian-Yu

    2016-01-01

    The aim of the present study was to comprehensively evaluate the clinical features and long-term outcomes of congenital aural stenosis (CAS). This study presents a retrospective review of patients who underwent meatoplasty for CAS at a tertiary referral hospital from 2008 to 2015. A total of 246 meatoplasty procedures were performed on 232 patients in the present study. We performed multivariate regression analysis. Except in the age < 6 years group, no significant difference was observed among different age groups for cholesteatoma formation, p > 0.05. Except for the stenosis of the external auditory canal (EAC) (>4 mm) group, the other stenosis of EAC groups were not associated with cholesteatoma formation, p > 0.05. Postoperative air-bone gaps (ABG) less than 30 dB occurred in 77.3% (99/128) of the patients, and the Jahrsdoerfer score was associated with postoperative ABG, p < 0.001. The complication rate of CAS was 13.8% (20/144), and males showed a higher risk for postoperative complications (OR, 6.563; 95% CI, 1.268-33.966, p = 0.025). These results indicate that meatoplasty was an effective surgical intervention for CAS, showing a stable hearing outcome with prolonged follow-up. There was no significant difference between the cholesteatoma and no cholesteatoma groups for hearing outcomes, p > 0.05. PMID:27257165

  17. Congenital Aural Stenosis: Clinical Features and Long-term Outcomes

    PubMed Central

    Li, Chen-long; Chen, Ying; Chen, Yong-zheng; Fu, Yao-yao; Zhang, Tian-yu

    2016-01-01

    The aim of the present study was to comprehensively evaluate the clinical features and long-term outcomes of congenital aural stenosis (CAS). This study presents a retrospective review of patients who underwent meatoplasty for CAS at a tertiary referral hospital from 2008 to 2015. A total of 246 meatoplasty procedures were performed on 232 patients in the present study. We performed multivariate regression analysis. Except in the age < 6 years group, no significant difference was observed among different age groups for cholesteatoma formation, p > 0.05. Except for the stenosis of the external auditory canal (EAC) (>4 mm) group, the other stenosis of EAC groups were not associated with cholesteatoma formation, p > 0.05. Postoperative air-bone gaps (ABG) less than 30 dB occurred in 77.3% (99/128) of the patients, and the Jahrsdoerfer score was associated with postoperative ABG, p < 0.001. The complication rate of CAS was 13.8% (20/144), and males showed a higher risk for postoperative complications (OR, 6.563; 95% CI, 1.268–33.966, p = 0.025). These results indicate that meatoplasty was an effective surgical intervention for CAS, showing a stable hearing outcome with prolonged follow-up. There was no significant difference between the cholesteatoma and no cholesteatoma groups for hearing outcomes, p > 0.05. PMID:27257165

  18. Clinical Outcomes of Anatomical Total Shoulder Arthroplasty in a Young, Active Population.

    PubMed

    Kusnezov, Nicholas; Dunn, John C; Parada, Stephen A; Kilcoyne, Kelly; Waterman, Brian R

    2016-01-01

    Glenohumeral arthritis in young, active patients poses many treatment challenges, and significant concerns about component loosening and failure limit the available surgical options. We conducted a study of the clinical outcomes of total shoulder arthroplasty (TSA) for glenohumeral arthritis in a young, high-demand population. We searched the Military Health System Management Analysis and Reporting Tool database to retrospectively review the cases of all US military service members who had undergone anatomical TSA (Current Procedural Terminology code 23472) between 2007 and 2014. Demographic information, occupational parameters, and clinical outcomes were extracted from electronic medical records. Twenty-four service members (26 shoulders) met the inclusion criteria. The cohort was predominantly male (n = 25). Mean age was 45.8 years (range, 35-54 years). The most common etiology of glenohumeral arthritis was post-instability arthropathy (50.0%). At mean follow-up of 41 months, 9 patients had a total of 12 complications (46.2%), including 6 component failures caused by neurologic injury (2 cases), adhesive capsulitis (2), and venous thrombosis (2). The reoperation rate for all component failures was 23.1% (6 cases, 5 patients). Ten patients (41.7%) remained on active duty at 2 years, and 5 (20.8%) were subsequently deployed. Ultimately, 9 patients (37.5%) underwent medical discharge for persistent shoulder disability. TSA in young, active patients provides reliable improvements in range of motion and pain. However, roughly one-third of patients in this study were unable to continue high-demand activities by 2 years after surgery. The short-term complication profile (46.2%) and reoperation rate for component failure (23.1%) should be emphasized during preoperative counseling. PMID:27552465

  19. Adaptive Radiotherapy for Head and Neck Cancer: Initial Clinical Outcomes from a Prospective Trial

    PubMed Central

    Schwartz, David L.; Garden, Adam S.; Thomas, Jimmy; Chen, Yipei; Zhang, Yongbin; Lewin, Jan; Chambers, Mark S.; Dong, Lei

    2011-01-01

    Purpose To present pilot toxicity and survival outcomes for a prospective trial investigating adaptive radiotherapy (ART) for oropharyngeal squamous cell carcinoma. Methods Twenty-four patients enrolled onto an IRB-approved clinical trial. Twenty-two patients were analyzed. Daily CT-guided setup and deformable image registration permitted serial mapping of CTVs and avoidance structures for ART planning. Primary site was base of tongue in 15 patients, tonsil in 6, and glossopharyngeal sulcus in 1. Twenty (91%) patients had AJCC stage IV disease. T stage distribution was 2 T1, 12 T2, 3 T3, 5 T4 and N stage distribution was 1 N0, 2 N1, 5 N2a, 12 N2b, and 2 N2c. Twenty-one (95%) patients received systemic therapy. Results With 31 month median follow up (range: 13-45), there has been no primary site failure and 1 nodal relapse, yielding 100% local and 95% regional disease control at 2 years. Baseline tumor size correlated with absolute volumetric treatment response (p = 0.018). Parotid volumetric change correlated with duration of feeding tube placement (p = 0.025). Acute toxicity was comparable to conventional IMRT results. Chronic toxicity and functional outcomes beyond 1 year were tabulated. Discussion This is the first prospective evaluation of morbidity and survival outcomes in patients with locally advanced head and neck cancer treated with automated adaptive replanning. ART can provide dosimetric benefit with only 1 or 2 mid-treatment replanning events. Our preliminary clinical outcomes document functional recovery and preservation of disease control at one-year follow-up and beyond. PMID:22138459

  20. Clinical Outcomes Associated with Treatment Modalities for Gastrointestinal Bezoars

    PubMed Central

    Park, So-Eun; Ahn, Ji Yong; Jung, Hwoon-Yong; Na, Shin; Park, Se Jeong; Lim, Hyun; Choi, Kwi-Sook; Lee, Jeong Hoon; Kim, Do Hoon; Choi, Kee Don; Song, Ho June; Lee, Gin Hyug; Kim, Jin-Ho

    2014-01-01

    Background/Aims With technical and instrumental advances, the endoscopic removal of bezoars is now more common than conventional surgical removal. We investigated the clinical outcomes in a patient cohort with gastrointestinal bezoars removed using different treatment modalities. Methods Between June 1989 and March 2012, 93 patients with gastrointestinal bezoars underwent endoscopic or surgical procedures at the Asan Medical Center. These patients were divided into endoscopic (n=39) and surgical (n=54) treatment groups in accordance with the initial treatment modality. The clinical feature and outcomes of these two groups were analyzed retrospectively. Results The median follow-up period was 13 months (interquartile range [IQR], 0 to 77 months) in 93 patients with a median age of 60 years (IQR, 50 to 73 years). Among the initial symptoms, abdominal pain was the most common chief complaint (72.1%). The bezoars were commonly located in the stomach (82.1%) in the endoscopic treatment group and in the small bowel (66.7%) in the surgical treatment group. The success rates of endoscopic and surgical treatment were 89.7% and 98.1%, and the complication rates were 12.8% and 33.3%, respectively. Conclusions Endoscopic removal of a gastrointestinal bezoar is an effective treatment modality; however, surgical removal is needed in some cases. PMID:25071905

  1. Outcomes for intra-substance free coracoid graft in patients with antero-inferior instability and glenoid bone loss in a population of high-risk athletes at a minimum follow-up of 2 years

    PubMed Central

    Arianjam, Afshin; Coghlan, Jennifer; Old, Jason; Sloan, Roger

    2014-01-01

    Background The aim of this retrospective case series study was to assess the outcomes of patients with recurrent anterior shoulder instability with antero-inferior glenoid bone loss treated with a specific open stabilization technique using intra-substance coracoid bone-grafting and Bankart repair. Methods Over a 4-year period, 34 shoulders in all male patients of mean age 21 years were stabilized with this technique. Pre- and postoperative function, motion and stability were assessed as part of Rowe stability scoring, and American Shoulder and Elbow Surgeons (ASES) and Oxford Instability were recorded, with at least 2 years of follow-up in all patients. Union of the graft was determined by post-operative computed tomography (CT) of the affected shoulder. Results For all cases, two redislocations (5.9%) and two subluxations occurred when continuing high-risk sport after 2 years. Post-operative scores [median, mean (SD): Rowe 77.5, 77.2 (19.5); ASES 94.2, 92 (7.7); Oxford 43, 41.2 (6)]. CT scans on 28 shoulders at a mean of 4.5 months after surgery showed non-union in three cases (10%). Conclusions These results demonstrate a high rate of success in cases of glenoid bone loss in the young contact athlete with recurrent instability treated with open stabilization and bone grafting.

  2. Electronic patient-reported outcome systems in oncology clinical practice.

    PubMed

    Bennett, Antonia V; Jensen, Roxanne E; Basch, Ethan

    2012-01-01

    Patient-reported outcome (PRO) questionnaires assess topics a patient can report about his or her own health. This includes symptoms (eg, nausea, fatigue, diarrhea, pain, or frequent urination), physical functioning (eg, difficulty climbing stairs or difficulty fastening buttons), and mental health (eg, anxiety, fear, or worry). Electronic PRO (ePRO) systems are used in oncology clinical care because of 1) their ability to enhance clinical care by flagging important symptoms and saving clinicians time; 2) the availability of standardized methods for creating and implementing PROs in clinics; and 3) the existence of user-friendly platforms for patient self-reporting like tablet computers and automated telephone surveys. Many ePRO systems can provide actionable links to clinical care such as summary reports in a patient's electronic medical record and real-time e-mail alerts to providers when patients report acute needs. This review presents 5 examples of ePRO systems currently in use in oncology practice. These systems support multiple clinical activities, including assessment of symptoms and toxicities related to chemotherapy and radiation, postoperative surveillance, and symptom management during palliative care and hospice. Patient self-reporting is possible both at clinical visits and between visits over the Internet or by telephone. The implementation of an ePRO system requires significant resources and expertise, as well as user training. ePRO systems enable regular monitoring of patient symptoms, function, and needs, and can enhance the efficiency and quality of care as well as communication with patients. PMID:22811342

  3. 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

  4. Clinical Outcomes of High Tibial Osteotomy for Knee Instability

    PubMed Central

    Dean, Chase S.; Liechti, Daniel J.; Chahla, Jorge; Moatshe, Gilbert; LaPrade, Robert F.

    2016-01-01

    Background: In recent years there has been an increasing interest in high tibial osteotomy (HTO) to treat patients with chronic knee instability due to posterolateral corner (PLC), posterior cruciate ligament (PCL), and anterior cruciate ligament (ACL) insufficiencies with concurrent malalignment in the coronal and/or sagittal plane. Purpose: To perform a systematic review of the use of HTO for the treatment of knee ligament instability with concurrent malalignment. Study Design: Systematic review; Level of evidence, 4. Methods: A systematic review of the literature was conducted for the treatment of combined knee ligament instability and malalignment with HTO using the Cochrane Central Register of Controlled Trials, PubMed, and MEDLINE (1980 to present); the queries were performed in July 2015. Terms searched included the following: high or proximal tibial osteotomy, unstable, instability, laxity, subluxation, tibial slope, and malalignment, in the knee joint. Inclusion criteria were as follows: HTO to treat instability of the knee joint in the sagittal and/or coronal plane, minimum 2-year follow-up with reported outcomes measures, English language, and human studies. Animal, basic science, and cadaveric studies were excluded as well as editorials, reviews, expert opinions, surveys, special topics, letters to the editor, and correspondence. Results: The search resulted in 460 studies. After applying exclusion criteria and removing duplicates, 13 studies were considered. Of the studies reviewed, knee ligament pathologies, previous surgeries, and measurement of knee stability were heterogeneous. However, all studies reported an improvement in knee stability after HTO. Most studies reported improvement in outcome scores. However, other studies did not provide preoperative scores for comparison. Reported complication rates ranged from 0% to 47%. Conclusion: Although HTO has been highly advocated and used in treating patients with ligamentous knee instability, there

  5. Clinicopathologic Features and Clinical Outcomes of Esophageal Gastrointestinal Stromal Tumor

    PubMed Central

    Feng, Fan; Tian, Yangzi; Liu, Zhen; Xu, Guanghui; Liu, Shushang; Guo, Man; Lian, Xiao; Fan, Daiming; Zhang, Hongwei

    2016-01-01

    Abstract Clinicopathologic features and clinical outcomes of gastrointestinal stromal tumors (GISTs) in esophagus are limited, because of the relatively rare incidence of esophageal GISTs. Therefore, the aim of the current study was to investigate the clinicopathologic features and clinical outcomes of esophageal GISTs, and to investigate the potential factors that may predict prognosis. Esophageal GIST cases were obtained from our center and from case reports and clinical studies extracted from MEDLINE. Clinicopathologic features and survivals were analyzed and compared with gastric GISTs from our center. The most common location was lower esophagus (86.84%), followed by middle and upper esophagus (11.40% and 1.76%). The majority of esophageal GISTs were classified as high-risk category (70.83%). Mitotic index was correlated with histologic type, mutational status, and tumor size. The 5-year disease-free survival and disease-specific survival were 65.1% and 65.9%, respectively. Tumor size, mitotic index, and National Institutes of Health risk classification were associated with prognosis of esophageal GISTs. Only tumor size, however, was the independent risk factor for the prognosis of esophageal GISTs. In comparison to gastric GISTs, the distribution of tumor size, histologic type, and National Institutes of Health risk classification were significantly different between esophageal GISTs and gastric GISTs. The disease-free survival and disease-specific survival of esophageal GISTs were significantly lower than that of gastric GISTs. The most common location for esophageal GISTs was lower esophagus, and most of the esophageal GISTs are high-risk category. Tumor size was the independent risk factor for the prognosis of esophageal GISTs. Esophageal GISTs differ significantly from gastric GISTs in respect to clinicopathologic features. The prognosis of esophageal GISTs was worse than that of gastric GISTs. PMID:26765432

  6. Repair Integrity and Clinical Outcomes Following Arthroscopic Rotator Cuff Repair

    PubMed Central

    Williams, Ariel A.; Mark, P.; DiVenere, Jessica Megan; Klinge, Stephen Austin; Arciero, Robert A.; Mazzocca, Augustus D.

    2016-01-01

    Objectives: To prospectively evaluate the effect of early versus delayed motion on repair integrity on 6-month postoperative magnetic resonance imaging (MRI) scans following rotator cuff repair, and to correlate repair integrity with clinical and functional outcomes. We hypothesized that repair integrity would differ between the early and delayed groups and that patients with repair failures would have worse clinical and functional outcomes. Methods: This was a prospective, randomized, single blinded clinical trial comparing an early motion (post-op day 2-3) to a delayed motion (post-op day 28) rehabilitation protocol following arthroscopic repair of isolated supraspinatus tears. All patients underwent MRI at 6 months post-operatively as part of the study protocol. A blinded board-certified and fellowship-trained orthopaedic surgeon (not part of the surgical team) reviewed operative photos and video to confirm the presence of a full thickness supraspinatus tear and to ensure an adequate and consistent repair. The same surgeon along with a blinded sports medicine fellowship-trained musculoskeletal radiologist independently reviewed all MRIs to determine whether the repair was intact at 6 months. Outcome measures were collected by independent evaluators who were also blinded to group assignment. These included the Western Ontario Rotator Cuff (WORC) index, Single Assessment Numeric Evaluation (SANE) ratings, pain scores, sling use, and physical exam data. Enrolled patients were followed at 6 weeks, 6 months, and 1 year. Results: From October 2008 to April 2012, 73 patients met all inclusion criteria and were willing to participate. 36 patients were randomized to delayed motion and 37 were randomized to early motion. The final study group at 6 months consisted of 58 study participants. Postoperative MRIs were obtained on all of these patients at 6 months regardless of whether or not they were progressing as expected. These MRIs demonstrated an overall failure rate of

  7. Outcome Measures for Clinical Trials in Interstitial Lung Diseases

    PubMed Central

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

    2015-01-01

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

  8. Clinical Outcome of Parotidectomy with Reconstruction: Experience of a Regional Head and Neck Cancer Unit

    PubMed Central

    Okoturo, Eyituoyo; Osasuyi, Anslem

    2016-01-01

    Background: Salivary gland pathologies represent a histologically diverse group of benign and malignant neoplasms. Currently, World Health Organization recognizes 13 benign and 24 malignant variants of all salivary gland neoplasms. Surgery continues to remain the main-stay for treatment of parotid gland neoplasms. The aim of this study was to document our experiences of the patients treated for parotid tumors and find out if any compelling variable predicted the relative clinical outcomes. Materials and Methods: This was a retrospective study, from records of parotidectomies performed at the operating theatre by the head and neck cancer division of the study institution between 2010 and 2013. Eligibility for study inclusion included cases with benign or malignant parotid neoplasms requiring surgical management with or without adjunct radiotherapy. The predictors of postoperative complications, overall survival (OS), and disease-free survival (DFS) were analyzed. Results: A total of 20 patients underwent parotidectomy. The mean age was 42 years. Tumors were located on the left parotid in 13 cases (65%) and the right parotid in 7 cases (35%). The surgical procedures comprised 16 superficial parotidectomies, 1 total parotidectomy, and 3 radical parotidectomy (inclusive of facial nerve sacrifice) and 2 neck dissections levels II–V. The reconstructive procedures were 2 facial nerve branch cable grafts, 1 end-to-end facial-facial nerve branch anastomoses, and 2 facial re-animation surgeries (temporalis muscle suspensions). A total of five cases (33.3%) had postoperative complications. 2 variables (length of surgery and neck dissection) were found to have an impact on postoperative complications that were statistically significant. Additionally, length of surgery was a significant predictor on the 2 years OS and DFS. Conclusion: The result of this study showed good clinical outcome, especially in the benign cases. The comprehensive clinical outcome of the malignant

  9. Clinical Outcomes of Percutaneous Plasma Disc Coagulation Therapy for Lumbar Herniated Disc Diseases

    PubMed Central

    Kim, Sung Chul; Cho, Ki Hong

    2012-01-01

    Objective This is prospective study of clinical outcomes of percutaneous plasma disc coagulation Therapy (PDCT) in patients with herniated lumbar disc disease (HLD) to evaluate the safety and efficacy in its clinical application and usefulness as a reliable alternative to microscopic discectomy. Methods Forty-six patients were enrolled in this study from April 2006 to June 2010. All patients had one-level HLD. Disc degeneration was graded on routine T2-weighted magnetic resonance Image (MRI) using the Pfirrmann's grading system and all index levels were grade 3 and grade 4. Indications for surgery were radiculopathy caused by disc protrusion with soft consistency. MRI was done at one month after the procedure in all patients to check post-PDCT change. The clinical outcomes were evaluated using Visual Analog Scales (VAS) score and MacNab's criteria. Results This study was approved by the Institutional Review Board of our institution. The age of the study population ranged from 16 to 59 years with a mean age of 37.2 years. There were 29 males and 17 females in this study. The mean period of clinical follow-up was 21 months. The average preoperative VAS score for radiculopathy was 7.4±1.4, while the final follow-up VAS score was 1.4±0.7 (p<0.001). In MacNab's criteria, 41 patients (89.1%) had achieved favorable improvement (excellent and good) until later follow-up. There were one patient from infection and two patients who needed to convert to open discectomy. Conclusion PDCT is a safe and efficient treatment modality in a selective patient with HLD. PMID:22396836

  10. Effects of 2-year calorie restriction on circulating levels of IGF-1, IGF-binding proteins and cortisol in nonobese men and women: a randomized clinical trial.

    PubMed

    Fontana, Luigi; Villareal, Dennis T; Das, Sai K; Smith, Steven R; Meydani, Simin N; Pittas, Anastassios G; Klein, Samuel; Bhapkar, Manjushri; Rochon, James; Ravussin, Eric; Holloszy, John O

    2016-02-01

    Young-onset calorie restriction (CR) in rodents decreases serum IGF-1 concentration and increases serum corticosterone levels, which have been hypothesized to play major roles in mediating its anticancer and anti-aging effects. However, little is known on the effects of CR on the IGF-1 system and cortisol in humans. To test the sustained effects of CR on these key hormonal adaptations, we performed a multicenter randomized trial of a 2-year 25% CR intervention in 218 nonobese (body mass index between 22 and 27.8 kg m(-2) ) young and middle-aged (20-50 years age range) men and women. Average CR during the first 6 months was 19.5 ± 0.8% and 9.1 ± 0.7% over the next 18 months of the study. Weight loss averaged 7.6 ± 0.3 kg over the 2-years period of which 71% was fat mass loss (P < 0.0001). Average CR during the CR caused a significant 21% increase in serum IGFBP-1 and a 42% reduction in IGF-1:IGFBP-1 ratio at 2 years (P < 0.008), but did not change IGF-1 and IGF-1:IGFBP-3 ratio levels. Serum cortisol concentrations were slightly but significantly increased by CR at 1 year only (P = 0.003). Calorie restriction had no effect on serum concentrations of PDGF-AB and TGFβ-1. We conclude, on the basis of the present and previous findings, that, in contrast to rodents, humans do not respond to CR with a decrease in serum IGF-1 concentration or with a sustained and biological relevant increase in serum cortisol. However, long-term CR in humans significantly and persistently increases serum IGFBP-1 concentration. PMID:26443692

  11. Association between inflammatory cytokines and the risk of post-stroke depression, and the effect of depression on outcomes of patients with ischemic stroke in a 2-year prospective study

    PubMed Central

    Jiao, Jian-Tong; Cheng, Chao; Ma, Ying-Jun; Huang, Jin; Dai, Min-Chao; Jiang, Chen; Wang, Cheng; Shao, Jun-Fei

    2016-01-01

    The association between inflammatory cytokines and the risk of post-stroke depression (PSD) remains unclear. The aim of the present study was to investigate this association and the effect of PSD on the outcomes of ischemic stroke patients. A total of 355 patients who had experienced ischemic stroke participated in inflammatory cytokine detection by ELISA, in addition to depression, quality of life (QOL) and body performance testing. Cox regression was used to evaluate the associations between PSD risk, inflammatory cytokines and the outcomes of patients. Measurement data was evaluated using Student's t test, and counted data was measured by χ2 test. The incidence of PSD during the 2-year follow-up was 23.1%. The risk of PSD elevated with increased interleukin (IL)-6 expression levels [hazard ratio (HR)=3.18; 95% confidence interval (CI), 1.37–7.36] following the adjustment of confounders. However, no significant associations were identified between PSD and other inflammatory cytokines. QOL and body performance in the depressed group were significantly worse compared with those in the non-depressed group. The risk of stroke recurrence in patients with depression increased two-fold compared with patients without depression (HR=2.020; 95% CI, 1.123–3.635; Ptrend=0.019). No significant associations between PSD and the risk of mortality (HR=1.497; 95% CI, 0.547–4.098) were observed. In conclusion, depression is prevalent in patients following ischemic stroke. IL-6 is positively associated with the risk of PSD, and may predict its development in patients following ischemic stroke. PSD correlates with outcomes of patients, and the effective management of PSD may improve the prognosis of patients. PMID:27588080

  12. Aberrant Hedgehog Signaling and Clinical Outcome in Osteosarcoma

    PubMed Central

    Lo, Winnie W.; Pinnaduwage, Dushanthi; Gokgoz, Nalan; Wunder, Jay S.; Andrulis, Irene L.

    2014-01-01

    Despite the importance of Hedgehog signaling in bone development, the relationship between Hedgehog pathway expression and osteosarcoma clinical characteristics and outcome has not been investigated. In this study of 43 high-grade human osteosarcoma samples, we detected high expression levels of the Hedgehog ligand gene, IHH, and target genes, PTCH1 and GLI1, in most samples. Further analysis in tumors of patients with localized disease at diagnosis identified coexpression of IHH and PTCH1 exclusively in large tumors. Higher levels of IHH were observed more frequently in males and patients with higher levels of GLI1 were more responsive to chemotherapy. Subgroup analysis by tumor size and IHH expression indicated that the well-known association between survival and tumor size was further refined when IHH levels were taken into consideration. PMID:24799831

  13. Clinical outcomes of enjoying sexualization among lesbian women.

    PubMed

    Erchull, Mindy J; Liss, Miriam

    2015-01-01

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

  14. Single momentary assessments are not reliable outcomes for clinical trials.

    PubMed

    Stone, Arthur A; Broderick, Joan E; Kaell, Alan T

    2010-09-01

    Patient reported outcomes (PROs) play an essential role in clinical trials, though questions have been raised about the accuracy of PROs using long recall periods. This paper examines the utility of a PRO employing a single momentary assessment of pain in a sample of community rheumatology patients. We explore the accuracy and reliability of a single assessment versus the average of multiple assessments taken over 1-week, which is considered a common outcome reporting period. A secondary analysis of 128 patients who monitored their pain intensity with momentary data collections several times a day for a week and 3 months later for another week allowed a comparison of randomly-selected single momentary assessments with the average of many assessments from the week. Results from cross-sectional analyses of the first week were that levels of pain measured by single points were not significantly different than the week average in 4 of 5 analyses, but these single-point assessments had much higher variance. Correlations of single-point and week averages were below 0.70. Longitudinal analysis of change scores across 3 months also demonstrated considerable unreliability of single-point measures, thus the statistical power generated by single-point assessments was considerably less than the more reliable week average. Our conclusion is that single momentary assessments, at least for representing an outcome over a period of a week, are not ideal measures. We discuss alternative measurement strategies for efficiently collecting PRO data for a 1-week period using end-of-day diaries or 7-day recall measures. PMID:20580945

  15. Clinical characteristics and outcome of hydronephrosis detected by prenatal ultrasonography.

    PubMed

    Lim, Dae Jung; Park, Jae-Young; Kim, Jeong Hyun; Paick, Sung Hyun; Oh, Seung-June; Choi, Hwang

    2003-12-01

    The widespread use of prenatal ultrasound results in an increased recognition of fetal hydronephrosis. To determine clinical characteristics and postnatal outcome of fetal hydronephrosis, we performed a retrospective study in children diagnosed as having fetal hydronephrosis between 1990 and 2001. 341 children with 427 dilated kidneys were included. Dilatation of the renal pelvis was caused by primary ureteropelvic junction obstruction in 65.6%, multicystic kidney in 9.4%, vesicoureteral reflux in 7.0%, duplex system in 5.4%, ureterovesical junction obstruction in 4.0%, and posterior urethral valves in 3.0%. Hydronephrosis resolved spontaneously in 126 (29.5%) kidneys, with 52.7% of mild hydronephrosis, and 2.6% of severe hydronephrosis. Mean interval to spontaneous resolution was 1.39 (+/- 1.41, SD) yr. Surgery was performed in 174 kidneys, including pyeloplasty in 105, ureteroneocystostomy in 23, transurethral incision in 11 and nephrectomy in 9. Most patients had initially high-grade hydronephrosis (p<0.05). Mild hydronephrosis appears to be relatively benign, and in most cases, dilatation improves with time, and thus surgical intervention is not required. On the other hand, moderate or severe hydronephrosis often results in a significantly poor outcome and requires surgical intervention, and therefore, requires closer follow-up both antenatally and postnatally. PMID:14676444

  16. Clinical Outcome after Colonic Resection in Women with Endometriosis

    PubMed Central

    Klugsberger, Bettina; Shamiyeh, Andreas; Oppelt, Peter; Jabkowski, Christina; Schimetta, Wolfgang; Haas, Dietmar

    2015-01-01

    Background. In severe forms of endometriosis, the colon or rectum may be involved. This study evaluated the functional results and long-term outcome after laparoscopic colonic resection for endometriosis. Patients and Methods. Questionnaire survey with 24 women who had experienced typical symptoms, including pelvic pain, infertility, and endometriotic lesions in the bowel and undergone laparoscopic surgery, including low anterior resection, from 2009 to 2012, was conducted. Results. Information about the postoperative outcome was obtained from 22 women and was analyzed statistically. Twenty-one had undergone low anterior resection; one patient required a primary Hartmann procedure due to a rectovaginal fistula. The conversion rate was 4.5%. Major complications occurred in one patient, including an anastomotic leakage, and a Hartmann procedure was carried out subsequently in this patient. The symptoms of pain during defecation, pelvic pain, dyspareunia, dysmenorrhea, and hematochezia showed clear improvement one year after the operation and at the time of the questionnaire. Conclusion. Laparoscopic low anterior resection for deeply infiltrative endometriosis is technically demanding but feasible and safe, and it improves the clinical symptoms of endometriosis in the bowel. PMID:26258139

  17. Prognostic factors for clinical outcomes after rotator cuff repair

    PubMed Central

    Pécora, José Otávio Reggi; Malavolta, Eduardo Angeli; Assunção, Jorge Henrique; Gracitelli, Mauro Emílio Conforto; Martins, João Paulo Sobreiro; Ferreira, Arnaldo Amado

    2015-01-01

    OBJECTIVE: To identify prognostic factors of postoperative functional outcomes. METHODS: Retrospective case series evaluating patients undergoing rotator cuff repair, analyzed by the UCLA score (pre and 12-month postoperative) and Magnetic Resonance Imaging (preoperative). Patients' intrinsic variables related to the injury and intervention were evaluated. Multivariate linear regression analysis was performed to determine variables impact on postoperative functional assessment. RESULTS: 131 patients were included. The mean UCLA score increased from 13.17 ± 3.77 to 28.73 ± 6.09 (p<0,001). We obtained 65.7% of good and excellent results. Age (r= 0.232, p= 0.004) and reparability of posterosuperior injuries (r= 0.151, p= 0.043) correlated with the functional assessment at 12 months. After multivariate linear regression analysis, only age was associated (p = 0.008). CONCLUSIONS: The surgical treatment of rotator cuff tears lead to good and excellent results in 65.6% of patients. Age was an independent predictor factor with better clinical outcomes by UCLA score in older patients. Level of Evidence IV, Case Series. PMID:26207092

  18. Clinical Features and Outcomes of Pasteurella multocida Infection

    PubMed Central

    Giordano, Antonio; Dincman, Toros; Clyburn, Benjamin E.; Steed, Lisa L.; Rockey, Don C.

    2015-01-01

    Abstract Pasteurella multocida, a zoonotic infectious organism, has most often been described in patients after an animal bite. Here, we characterize the clinical features and outcomes of P multocida infection in a large cohort of patients according to the presence or absence of an animal bite. We retrospectively searched MUSC's laboratory information system for all patients with positive P multocida cultures from 2000 to 2014. Extensive data were abstracted, including clinical and outcome data. The Charlson comorbidity index (CCI) was used to assess comorbidities among patients. We identified 44 patients with P multocida infections, including 25 with an animal bite. The average age was 64 years and the majority of patients were women (N = 30). There was no difference in age and sex distribution among those with and without a bite (P = 0.38 and 0.75, respectively). A CCI ≥1 was significantly associated with the absence of a bite (P = 0.006). Patients presenting without a bite were more frequently bacteremic (37% vs 4%, respectively, P = 0.001), and were hospitalized more often (84% vs 44%, respectively, P = 0.012). Of the 8 patients who required intensive care unit (ICU)-based care, 7 were non-bite-related. There were 4 deaths, all occurring in patients not bitten. P multocida infections not associated with an animal bite were often associated with bacteremia, severe comorbidity(ies), immune-incompetent states, the need for ICU management, and were associated with substantial mortality. PMID:26356688

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

    PubMed Central

    Lobo, Tasso Julio; Pachon, Carlos Thiene; Pachon, Jose Carlos; Pachon, Enrique Indalecio; Pachon, Maria Zelia; Pachon, Juan Carlos; Santillana, Tomas Guillermo; Zerpa, Juan Carlos; Albornoz, Remy Nelson; Jatene, Adib Domingos

    2015-01-01

    Background Heart failure and atrial fibrillation (AF) often coexist in a deleterious cycle. Objective To evaluate the clinical and echocardiographic outcomes of patients with ventricular systolic dysfunction and AF treated with radiofrequency (RF) ablation. Methods Patients with ventricular systolic dysfunction [ejection fraction (EF) <50%] and AF refractory to drug therapy underwent stepwise RF ablation in the same session with pulmonary vein isolation, ablation of AF nests and of residual atrial tachycardia, named "background tachycardia". Clinical (NYHA functional class) and echocardiographic (EF, left atrial diameter) data were compared (McNemar test and t test) before and after ablation. Results 31 patients (6 women, 25 men), aged 37 to 77 years (mean, 59.8±10.6), underwent RF ablation. The etiology was mainly idiopathic (19 p, 61%). During a mean follow-up of 20.3±17 months, 24 patients (77%) were in sinus rhythm, 11 (35%) being on amiodarone. Eight patients (26%) underwent more than one procedure (6 underwent 2 procedures, and 2 underwent 3 procedures). Significant NYHA functional class improvement was observed (pre-ablation: 2.23±0.56; postablation: 1.13±0.35; p<0.0001). The echocardiographic outcome also showed significant ventricular function improvement (EF pre: 44.68%±6.02%, post: 59%±13.2%, p=0.0005) and a significant left atrial diameter reduction (pre: 46.61±7.3 mm; post: 43.59±6.6 mm; p=0.026). No major complications occurred. Conclusion Our findings suggest that AF ablation in patients with ventricular systolic dysfunction is a safe and highly effective procedure. Arrhythmia control has a great impact on ventricular function recovery and functional class improvement. PMID:25387404

  20. Clinical Manifestations and Treatment Outcomes of Eosinophilic Gastroenteritis in Children

    PubMed Central

    Choi, Jong Sub; Choi, Shin Jie; Lee, Kyung Jae; Kim, Ahlee; Yoo, Jung Kyung; Yang, Hye Ran; Moon, Jin Soo; Chang, Ju Young; Kang, Gyeong Hoon

    2015-01-01

    Purpose The aim of the present study was to investigate the clinical features and outcome of eosinophilic gastroenteritis (EGE) in children. Methods Our study enrolled 24 children who were diagnosed with EGE from 1993 to 2014 at the Department of Pediatrics, Seoul National University Children's Hospital. The patients' clinical manifestations, treatments, and outcomes were reviewed from the medical records. Results The mean age at diagnosis was 5.3 years. Most patients had gastrointestinal symptoms including diarrhea (54.2%) and abdominal pain (45.8%). Peripheral eosinophilia was present in 91.7% of the patients. Thirteen patients (54.2%) showed anemia, and 15 patients (62.5%) had hypoalbuminemia. EGE was classified as mucosal, subserosal, or muscular in 75.0%, 20.8%, and 4.2% of cases, respectively. Three patients showed gastroduodenal ulcers upon endoscopic analysis. A history of allergy was reported in 13 patients, including atopic dermatitis, allergic rhinitis, and asthma. Five patients (20.8%) improved with food restrictions. Among the 19 patients treated with steroids, 11 (57.9%) discontinued steroid treatment without subsequent relapse, 4 (21.1%) relapsed after ceasing steroid treatment, and 4 (21.1%) showed no response to steroids. Two patients who were resistant to steroids underwent therapeutic surgery. The presence of gastroduodenal ulcers was significantly associated with relapse and steroid resistance. Conclusion A high suspicion of EGE is warranted when children have nonspecific gastrointestinal symptoms and peripheral eosinophilia. Most patients improved with food restrictions or steroid treatment, although one-third of patients showed a relapse or steroid resistance. PMID:26770900

  1. Different Placebos, Different Mechanisms, Different Outcomes: Lessons for Clinical Trials

    PubMed Central

    Benedetti, Fabrizio; Dogue, Sara

    2015-01-01

    Clinical trials use placebos with the assumption that they are inert, thus all placebos are considered to be equal. Here we show that this assumption is wrong and that different placebo procedures are associated to different therapeutic rituals which, in turn, trigger different mechanisms and produce different therapeutic outcomes. We studied high altitude, or hypobaric hypoxia, headache, in which two different placebos were administered. The first was placebo oxygen inhaled through a mask, whereas the second was placebo aspirin swallowed with a pill. Both placebos were given after a conditioning procedure, whereby either real oxygen or real aspirin was administered for three consecutive sessions to reduce headache pain. We found that after real oxygen conditioning, placebo oxygen induced pain relief along with a reduction in ventilation, blood alkalosis and salivary prostaglandin (PG)E2, yet without any increase in blood oxygen saturation (SO2). By contrast, after real aspirin conditioning, placebo aspirin induced pain relief through the inhibition of all the products of cyclooxygenase, that is, PGD2, PGE2, PGF2, PGI2, thromboxane (TX)A2, without affecting ventilation and blood alkalosis. Therefore, two different placebos, associated to two different therapeutic rituals, used two different pathways to reduce headache pain. The analgesic effect following placebo oxygen was superior to placebo aspirin. These findings show that different placebos may use different mechanisms to reduce high altitude headache, depending on the therapeutic ritual and the route of administration. In clinical trials, placebos and outcome measures should be selected very carefully in order not to incur in wrong interpretations. PMID:26536471

  2. Clinical outcomes of the high-performance membrane dialyzer.

    PubMed

    Koda, Yutaka

    2011-01-01

    HPM (high-performance membrane or high-flux membrane) has better biocompatibility and higher capacity to remove retention solutes of large molecular weight, which has been proven to be toxic especially to cardiovascular and skeletal organs. To date, several non-randomized observational studies have shown a reduction in morbidity and mortality in HPM-treated patients compared with low-flux conventional membrane. Meanwhile, two randomized controlled trials were unable to reveal the superiority of high-flux membrane in survival of all-cause mortality, but suggested a significant benefit by subgroup analyses or post-hoc analyses in patients with diabetes, hypoalbuminemia and long duration of prior dialysis. Thus, the results of the published studies are conflicting and it still cannot be explained whether the effect is based on the biocompatibility of the membrane or on the differences in the clearance of middle molecules, or on the microbiological purity of dialysate which improved simultaneously with the flux increment. As survival outcome might be determined by additional multiple confounding factors, dialysis-related or non-dialysis-related, investigations to control them are difficult to perform. Although the clinical results are non-conclusive and it is still unanswered how much large molecule removal is required to improve outcomes in routine clinical practice, there is a considerable amount of biological plausibility for high-flux dialysis or middle molecule removal. Further trials will be required to confirm what patient group benefits the most, the magnitude of advantages and how large the molecules are and how much molecule removal is acceptable using advanced high-performance dialyzers. Dispersing hazardous effects by a low-quality therapy should be taken more seriously than practicing a high-quality therapy of uncertain superiority. PMID:21865777

  3. Comparative analysis of carrier-based obturation and lateral compaction: a retrospective clinical outcomes study.

    PubMed

    Hale, Robert; Gatti, Robert; Glickman, Gerald N; Opperman, Lynne A

    2012-01-01

    The purpose of this retrospective study was to compare the outcome of primary endodontic treatment using a standardized cleaning and shaping technique and obturation with either lateral compaction or carrier-based obturation. Patients received primary endodontic treatment in the predoctoral dental clinic using a standardized cleaning and shaping protocol. All root canals were obturated using AH Plus(TM) sealer with lateral compaction of gutta-percha (LC) or carrier-based obturation (CBO). A total of 205 cases met the inclusion criteria. 71 teeth in 60 patients were recalled after 2 years and evaluated both clinically and radiographically by two independent examiners. Success was defined as a lack of clinical symptoms and a normal periodontal ligament space or reduction in size of a previously existing periapical radiolucency. Chi-square and logistic regression were used for statistical analysis with a significance level of P < 0.05. There was no difference in success rates between cases obturated with LC or CBO (P = 0.802); overall success rate was 83%. Molars had a significantly lower success rate (53%) than premolar and anterior teeth (89%) (P = 0.005), irrespective of the obturation technique used. When a standardized cleaning and shaping protocol was used by predoctoral dental students in a controlled university setting, there was no difference in success rates between cases obturated with LC or CBO. PMID:22567010

  4. Clinical outcome comparison between TIPS and EBL in patients with cirrhosis and portal vein thrombosis.

    PubMed

    Wang, Zhu; Zhao, He; Wang, Xiaoze; Zhang, Hailong; Jiang, Mingshan; Tsauo, Jiaywei; Luo, Xuefeng; Yang, Li; Li, Xiao

    2015-08-01

    The aim of this study is to compare the clinical outcomes of transjugular intrahepatic portosystemic shunt (TIPS) and endoscopic band ligation (EBL) in patients with cirrhosis and portal vein thrombosis (PVT). We retrospectively reviewed the January to September 2010 data from our database and included 25 patients with cirrhosis and PVT who underwent successful TIPS creation. We selected another 25 patients who underwent EBL matching for age, sex, and Child-Pugh-Turcotte class. The outcome measures included changes in the PVT status before and after the treatments, the rebleeding rate, and the overall survival. The mean follow-up was 25.1 ± 8.7 months in the EBL group and 25.6 ± 8.5 months in the TIPS group (P = 0.85). After treatments, the PVT severity improved in 40% and worsened in 25% of patients who did not undergo TIPS, compared with 87% and none of the patients who underwent TIPS (P < 0.001). Previous splenectomy (OR 0.13, 95% CI 0.02-0.76, P = 0.024) and patency status of TIPS (OR 20.8, 95% CI 3.0-141.8, P = 0.002) were the independent factors associated with PVT disappearance. The 1- and 2-year rebleeding rates were, respectively, 44.6% and 59.0% in the EBL group, and 12.5% and 25.2% in the TIPS group (P = 0.002). The 1- and 2-year survival rates were, respectively, 95.7% and 85.2% in the EBL group, and 96% and 78.7% in the TIPS group (P = 0.203). The MELD score was the only independent predictive factor for survival (HR 1.73, 95% CI 1.27-2.37, P = 0.001). Compared with EBL, TIPS contributed to PVT improvement and reduced the risk of rebleeding without providing a survival benefit for patients with PVT. PMID:25504374

  5. COMPASS identifies T-cell subsets correlated with clinical outcomes

    PubMed Central

    Lin, Lin; Finak, Greg; Ushey, Kevin; Seshadri, Chetan; Hawn, Thomas R.; Frahm, Nicole; Scriba, Thomas J.; Mahomed, Hassan; Hanekom, Willem; Bart, Pierre-Alexandre; Pantaleo, Giuseppe; Tomaras, Georgia D.; Rerks-Ngarm, Supachai; Kaewkungwal, Jaranit; Nitayaphan, Sorachai; Pitisuttithum, Punnee; Michael, Nelson L.; Kim, Jerome H.; Robb, Merlin L.; O’Connell, Robert J.; Karasavvas, Nicos; Gilbert, Peter; DeRosa, Stephen; McElrath, M. Juliana

    2015-01-01

    Advances in flow cytometry and other single-cell technologies have enabled high-dimensional, high-throughput measurements of individual cells and allowed interrogation of cell population heterogeneity. Computational tools to take full advantage of these technologies are lacking. Here, we present COMPASS, a computational framework for unbiased polyfunctionality analysis of antigen-specific T-cell subsets. COMPASS uses a Bayesian hierarchical framework to model all observed functional cell subsets and select those most likely to exhibit antigen-specific responses. Cell-subset responses are quantified by posterior probabilities, while subject-level responses are quantified by two novel summary statistics that can be correlated directly with clinical outcome, and describe the quality of an individual’s (poly)functional response. Using three clinical datasets of cytokine production we demonstrate how COMPASS improves characterization of antigen-specific T cells and reveals novel cellular correlates of protection in the RV144 HIV vaccine efficacy trial that are missed by other methods. COMPASS is available as open-source software. PMID:26006008

  6. Intracranial Hypertension in Children: Etiologies, Clinical Features, and Outcome.

    PubMed

    Masri, Amira; Jaafar, Amani; Noman, Rasha; Gharaibeh, Almutez; Ababneh, Osama H

    2015-10-01

    This retrospective study aimed to describe the clinical presentations, possible causes, and outcomes of children with idiopathic intracranial hypertension who presented to the authors' clinic. The mean age at onset of symptoms in the authors' cohort of 19 children was 6 years (range: 7 months to 12 years). Most patients (90%) were under 11 years old and (84.2%) symptomatic. The probable cause was identified in 7/19 (37.0%) patients. The most common cause was vitamin D deficiency (26.3%). Other associated probably coincidental comorbidities included sinusitis (5/19, 26.3%), hypophosphatasia (1/19), Pyle disease (1/19), and measles vaccine (1/19). Apart from 2 patients who required lumboperitoneal shunt, the cerebrospinal fluid pressure returned to normal in all patients within a period of 6 weeks to 1 year (average, 5 months). Of those who followed up with the authors' ophthalmologist, 30.7% developed optic atrophy or pallor; 75% of these patients had previous ocular comorbidities. PMID:25762586

  7. Clinical outcomes of symptomatic arterioportal fistulas after transcatheter arterial embolization

    PubMed Central

    Hirakawa, Masakazu; Nishie, Akihiro; Asayama, Yoshiki; Ishigami, Kousei; Ushijima, Yasuhiro; Fujita, Nobuhiro; Honda, Hiroshi

    2013-01-01

    AIM: To evaluate the complications and clinical outcomes of transcatheter arterial embolization (TAE) for symptoms related to severe arterioportal fistulas (APFs). METHODS: Six patients (3 males, 3 females; mean age, 63.8 years; age range, 60-71 years) with chronic liver disease and severe APFs due to percutaneous intrahepatic treatment (n = 5) and portal vein (PV) tumor thrombosis of hepatocellular carcinoma (n = 1) underwent TAE for symptoms related to severe APFs [refractory ascites (n = 4), hemorrhoidal hemorrhage (n = 1), and hepatic encephalopathy (n = 1)]. Control of symptoms related to APFs and complications were evaluated during the follow-up period (range, 4-57 mo). RESULTS: In all patients, celiac angiography revealed immediate retrograde visualization of the main PV before TAE, indicating severe APF. Selective TAE for the hepatic arteries was performed using metallic coils (MC, n = 4) and both MCs and n-butyl cyanoacrylate (n = 2). Three patients underwent repeated TAEs for residual APFs and ascites. Four patients developed PV thrombosis after TAE. During the follow-up period after TAE, APF obliteration and symptomatic improvement were obtained in all patients. CONCLUSION: Although TAE for severe APFs may sometimes be complicated by PV thrombosis, TAE can be an effective treatment to improve clinical symptoms related to severe APFs. PMID:23494252

  8. COMPASS identifies T-cell subsets correlated with clinical outcomes.

    PubMed

    Lin, Lin; Finak, Greg; Ushey, Kevin; Seshadri, Chetan; Hawn, Thomas R; Frahm, Nicole; Scriba, Thomas J; Mahomed, Hassan; Hanekom, Willem; Bart, Pierre-Alexandre; Pantaleo, Giuseppe; Tomaras, Georgia D; Rerks-Ngarm, Supachai; Kaewkungwal, Jaranit; Nitayaphan, Sorachai; Pitisuttithum, Punnee; Michael, Nelson L; Kim, Jerome H; Robb, Merlin L; O'Connell, Robert J; Karasavvas, Nicos; Gilbert, Peter; C De Rosa, Stephen; McElrath, M Juliana; Gottardo, Raphael

    2015-06-01

    Advances in flow cytometry and other single-cell technologies have enabled high-dimensional, high-throughput measurements of individual cells as well as the interrogation of cell population heterogeneity. However, in many instances, computational tools to analyze the wealth of data generated by these technologies are lacking. Here, we present a computational framework for unbiased combinatorial polyfunctionality analysis of antigen-specific T-cell subsets (COMPASS). COMPASS uses a Bayesian hierarchical framework to model all observed cell subsets and select those most likely to have antigen-specific responses. Cell-subset responses are quantified by posterior probabilities, and human subject-level responses are quantified by two summary statistics that describe the quality of an individual's polyfunctional response and can be correlated directly with clinical outcome. Using three clinical data sets of cytokine production, we demonstrate how COMPASS improves characterization of antigen-specific T cells and reveals cellular 'correlates of protection/immunity' in the RV144 HIV vaccine efficacy trial that are missed by other methods. COMPASS is available as open-source software. PMID:26006008

  9. Multilevel analysis of clinical parameters in chronic periodontitis after root planing/scaling, surgery, and systemic and local antibiotics: 2-year results

    PubMed Central

    Mdala, Ibrahimu; Haffajee, Anne D.; Socransky, Sigmund S.; de Blasio, Birgitte Freiesleben; Thoresen, Magne; Olsen, Ingar; Goodson, J. Max

    2012-01-01

    Aim Find the periodontal treatment that best maintained clinical results over time evaluated by changes in pocket depth (PD) and clinical attachment level (CAL). Methods 229 patients with chronic periodontitis from USA (n=134) and Sweden (n=95) were randomly assigned to eight groups receiving (1) scaling+root planing (SRP) alone or combined with (2) surgery (SURG)+systemic amoxicillin (AMOX)+systemic metronidazole (MET); (3) SURG+local tetracycline (TET); (4) SURG; (5) AMOX+MET+TET; (6) AMOX+MET; (7) TET; and (8) SURG+AMOX+MET+TET. Antibiotics were given immediately after SRP. Plaque, gingival redness, bleeding on probing, suppuration, PD, and CAL were recorded at baseline and after 3, 6, 12, 18, and 24 months. Treatment effects were evaluated by linear multilevel regression and logistic multilevel regression models. We considered only data from sites with a baseline PD of at least 5 mm of 187 patients completing the study. Results Surgically treated patients experienced most CAL loss. Adjunctive therapy including SURG was most effective in reducing PD. Combining SURG with AMOX, MET, and TET gave significant clinical benefits. Past and current smoking habits were significant predictors of deeper PD. Only current smoking was a significant predictor of CAL loss. Bleeding, accumulation of plaque, gingival redness, and suppuration were significant predictors of further CAL loss and deeper PD. Conclusions Both surgical and non-surgical therapies can be used to arrest chronic periodontitis. SURG+AMOX+MET+TET gave best maintenance of clinical results. PMID:22545190

  10. Evaluation of the Clinical Decisions Made for 2-Year-Olds Referred for Speech and Language Therapy: A Follow-Up Study

    ERIC Educational Resources Information Center

    Emanuel, Rosemary; Chiat, Shula; Roy, Penny

    2007-01-01

    Background: Clinicians in the UK rely mainly on informal observations and structured and semi-structured tasks rather than standardized testing in their assessments of pre-school children referred with speech and language difficulties. The informal nature of the clinical decision-making process at this age is unsurprising given the dearth of…

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

    PubMed Central

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

    2015-01-01

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

  12. NFlex Dynamic Stabilization System : Two-Year Clinical Outcomes of Multi-Center Study

    PubMed Central

    Coe, Jeffrey D.; Kitchel, Scott H.; Meisel, Hans Jörg; Wingo, Charles H.; Lee, Soo Eon

    2012-01-01

    Objective Pedicle-based dynamic stabilization systems, in which semi-rigid rods or cords are used to restrict or control spinal segmental motion, aim to reduce or eliminate the drawbacks associated with rigid fusion. In this study, we analyzed the two-year clinical outcomes of patients treated with the NFlex (Synthes Spine, Inc.), a pedicle-based dynamic stabilization system. Methods Five sites participated in a retrospective study of 72 consecutive patients who underwent NFlex stabilization. Of these 72 patients, 65 were available for 2-year follow-up. Patients were included based on the presence of degenerative disc disease (29 patients), degenerative spondylolisthesis (16 patients), lumbar stenosis (9 patients), adjacent segment degeneration (6 patients), and degenerative lumbar scoliosis (5 patients). The clinical outcome measures at each assessment were Visual Analogue Scale (VAS) to measure back pain, and Oswestry Disability Index (ODI) to measure functional status. Radiographic assessments included evidence of instrumentation failure or screw loosening. Results Sixty-five patients (26 men and 39 women) with a mean age of 54.5 years were included. Mean follow-up was 25.6 months. The mean VAS score improved from 8.1 preoperatively to 3.8 postoperatively, representing a 53% improvement, and the ODI score from 44.5 to 21.8, representing a 51% improvement. Improvements in pain and disability scores were statistically significant. Three implant-related complications were observed. Conclusion Posterior pedicle-based dynamic stabilization using the NFlex system seems effective in improving pain and functional scores, with sustained clinical improvement after two years. With appropriate patient selection, it may be considered an effective alternative to rigid fusion. PMID:22949963

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

    PubMed Central

    2011-01-01

    Objective Juvenile Systemic Lupus Erythematosus (SLE) varies by location and ethnicity. This study describes the clinical, laboratory profile and outcome of juvenile SLE seen at Philippine General Hospital (PGH) from 2004-2008. Method Medical charts of all Filipino Juvenile SLE cases admitted at PGH during the 5-year period were reviewed collecting demographic profile, clinical and laboratory manifestations and treatment during disease course. Results Seventy-eight cases of juvenile SLE were reviewed. There were 7 boys and 71 girls. The mean age at diagnosis was 14 years (SD 2.7) with a range of 8-18 years. Fever (52.5%) and malar rash (41.0%) were the most common features at disease onset. At the time of diagnosis, the most common features were malar rash (65.3%), renal involvement (62.8%) and photosensitivity (55.1%). Mucocutaneous (92.3%), renal (71.7%) and hematologic (69.2%) involvement were the most common features during the entire course of illness. Infection (34.5%) and neurologic (19.0%) complications were observed most frequently. Corticocosteroid treatment was given in most of the patients in the form of prednisone (97.4%) and concomitant methylprednisolone intravenous pulses (29.4%). Nine patients died during the study period. The overall 5-year mortality rate was 11.5%. Infection (77.0%) was the most frequent cause of death. Conclusion Malar rash was a common feature at disease onset and at diagnosis among Filipinos with juvenile SLE. Throughout the disease course, renal involvement occurs in 71.7% of patients. Infection was the leading cause of complication and death. The clinical presentations of Filipinos with juvenile SLE were similar to juvenile SLE in other countries. PMID:21306603

  14. Diagnostic Issues, Clinical Characteristics, and Outcomes for Patients with Fungemia▿

    PubMed Central

    Arendrup, Maiken Cavling; Sulim, Sofia; Holm, Anette; Nielsen, Lene; Nielsen, Susanne Dam; Knudsen, Jenny Dahl; Drenck, Niels Erik; Christensen, Jens Jørgen; Johansen, Helle Krogh

    2011-01-01

    This study investigated microbiological, clinical, and management issues and outcomes for Danish fungemia patients. Isolates and clinical information were collected at six centers. A total of 334 isolates, 316 episodes, and 305 patients were included, corresponding to 2/3 of the national episodes. Blood culture positivity varied by system, species, and procedure. Thus, cases with concomitant bacteremia were reported less commonly by BacT/Alert than by the Bactec system (9% [11/124 cases] versus 28% [53/192 cases]; P < 0.0001), and cultures with Candida glabrata or those drawn via arterial lines needed longer incubation. Species distribution varied by age, prior antifungal treatment (57% occurrence of C. glabrata, Saccharomyces cerevisiae, or C. krusei in patients with prior antifungal treatment versus 28% occurrence in those without it; P = 0.007), and clinical specialty (61% occurrence of C. glabrata or C. krusei in hematology wards versus 27% occurrence in other wards; P = 0.002). Colonization samples were not predictive for the invasive species in 11/100 cases. Fifty-six percent of the patients had undergone surgery, 51% were intensive care unit (ICU) patients, and 33% had malignant disease. Mortality increased by age (P = 0.009) and varied by species (36% for C. krusei, 25% for C. parapsilosis, and 14% for other Candida species), severity of underlying disease (47% for ICU patients versus 24% for others; P = 0.0001), and choice but not timing of initial therapy (12% versus 48% for patients with C. glabrata infection receiving caspofungin versus fluconazole; P = 0.023). The initial antifungal agent was deemed suboptimal upon species identification in 15% of the cases, which would have been 6.5% if current guidelines had been followed. A large proportion of Danish fungemia patients were severely ill and received suboptimal initial antifungal treatment. Optimization of diagnosis and therapy is possible. PMID:21715585

  15. Randomized comparison between the cemented Scientific Hip Prosthesis and Omnifit: 2-year DEXA and minimum 10-year clinical follow-up.

    PubMed

    Broeke, René H M Ten; Harings, Steffie E J M; Emans, Pieter J; Jutten, Liesbeth M C; Kessels, Alfons G H; Geesink, Rudolph G T

    2013-09-01

    Radiostereometry (RSA) of the cemented Scientific Hip Prosthesis (SHP) reported excessive migration and predicted high failure rates. In a prospective randomized clinical trial we compared minimum 10 years results of the SHP (n=38) with the Omnifit-stem (n=37). Two-year bone remodelling, compared with dual energy x-ray absorptiometry and assessed in regions of interest A-D based on the 7 Gruen zones, showed better periprosthetic bone preservation around the SHP in all but one regions (P<.05). At 10 years Harris Hip Score was better for the SHP (P=.0001) but Oxford Hip Score was the same (P=.79). There were no revisions in either group, but radiographic loosening was definite in 1 SHP and 1 Omnifit. Based on earlier RSA studies, the rough surface finish of the SHP was expected to cause cement abrasion, osteolysis and inferior survival. However our clinical and remodelling results could not confirm these expectations, suggesting that the link of early migration and mid-term clinical results is not sufficiently clear for the SHP. PMID:23453292

  16. Evaluation of Clinical and Immunological Responses: A 2-Year Follow-Up Study in Children with Allergic Rhinitis due to House Dust Mite

    PubMed Central

    Moed, Heleen; Gerth van Wijk, Roy; Hendriks, Rudi W.; van der Wouden, J. C.

    2013-01-01

    Background. Allergic rhinitis is a disease with polarization towards Th2 and a defect of regulatory T cells. Immunological changes have been reported after immunotherapy treatment. However, there is not much known about the natural course of allergic rhinitis with respect to clinical manifestation and the relation with immunological responses. Objective. To evaluate clinical symptoms of allergic rhinitis, in relation to in vivo allergen-specific skin responses and in vitro allergen-specific effector and regulatory T cells determined at baseline and after two years. Methods. From a large trial, 59 children were randomly selected. The following variables were compared: clinical symptoms, allergen skin tests, specific IgE, T-cell proliferation, IL-5, IL-13, IFN-gamma, IL-10, TGF-beta, CD4+CD25hi cells, and Foxp3 expression. Results. Allergic symptoms had decreased after two years. Whereas skin test reactions correlated between years 0 and 2, there was no change in the size of the reaction. Also, proinflammatory reactions did not change after two years, with a positive correlation between years 0 and 2. No relevant changes were observed with respect to regulatory cells. Conclusion. Whereas, comparable to immunotherapy, allergic complaints decrease, the immunological changes of specific T-cell activity (both effector cells and regulator cells) which are observed after immunotherapy, do not change. PMID:23737646

  17. Clinical Evaluation of the Regenerative Potential of EMD and NanoHA in Periodontal Infrabony Defects: A 2-Year Follow-Up

    PubMed Central

    Zeza, Blerina; Ambrosca, Marco; Paolantonio, Michele; Sammartino, Gilberto; Mongardini, Claudio

    2014-01-01

    Introduction. The aim of this retrospective study was to compare the clinical efficacy of four different surgical techniques in promoting periodontal regeneration in patients with infrabony defects: open flap debridement, application of enamel matrix derivatives (EMD), nanohydroxyapatite (nanoHA) application, and combined nanoHA and EMD application. Probing attachment level (PAL), pocket depth (PD), and position of gingival margin at completion of therapy (REC) were measured. Materials and Methods. Data were collected from 64 healthy patients (34 women and 30 men, mean age 37,7 years). Clinical indices were measured by a calibrated examiner at baseline and at 12, 18, and 24 months. The values obtained for each treatment were compared using nonparametric tests. Results. All treatments resulted in a tendency toward PD reduction over time, with improvements in REC and PAL. The differences in PD, REC, and PAL values at baseline compared with values after 12, 18, and 24 months were statistically significant for all treatments. Statistically significant differences in PAL and PD were detected between nanoHA and nanoHA + EMD at 12, 18, and 24 months. Conclusion. In this study, EMD and nanoHA used together in patients with infrabony periodontal lesions had better clinical efficacy than nanoHA alone, EMD alone, or open flap debridement. PMID:25276793

  18. Correlation of Clinical Outcomes with β-Glucan Levels in Patients with Invasive Candidiasis

    PubMed Central

    Sims, Charles R.; Mohr, John; Rodriguez, Jose; Finkelman, Malcolm; Ostrosky-Zeichner, Luis

    2012-01-01

    The correlation of β-glucan (BG) levels with clinical outcomes in invasive candidiasis (IC) remains unknown. Patients with proven IC were followed prospectively from diagnosis to outcome with twice-weekly serum BG sampling. Correlation of BG with clinical outcome was assessed in each patient. BG levels tend to decrease in successfully treated patients and increase in treatment failures. BG levels may be useful as surrogates for outcome evaluation of IC. PMID:22461680

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

    PubMed Central

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

    2016-01-01

    Malnutrition has been associated with increased morbidity and mortality. The objective of this study was to determine the nutritional status and micronutrient levels of hospitalized patients in an infectious disease clinic and investigate their association with adverse clinical outcomes. The nutritional status of the study participants was assessed using the Nutritional Risk Screening 2002 (NRS 2002) and micronutrient levels and routine biochemical parameters were tested within the first 24 h of the patient’s admission. The incidence of zinc, selenium, thiamine, vitamin B6, vitamin B12 deficiency were 66.7% (n = 40), 46.6% (n = 29), 39.7% (n = 27), 35.3% (n = 24), 14.1% (n = 9), respectively. Selenium levels were significantly higher in patients with urinary tract infections, but lower in soft tissue infections. Copper levels were significantly higher in patients with soft tissue infections. In the Cox regression models, lower albumin, higher serum lactate dehydrogenase levels and higher NRS-2002 scores were associated with increased death. Thiamine, selenium, zinc and vitamin B6 deficiencies but not chromium deficiencies are common in infectious disease clinics. New associations were found between micronutrient levels and infection type and their adverse clinical outcomes. Hypoalbuminemia and a high NRS-2002 score had the greatest accuracy in predicting death, systemic inflammatory response syndrome and sepsis on admission. PMID:26938553

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

    PubMed

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

    2016-03-01

    Malnutrition has been associated with increased morbidity and mortality. The objective of this study was to determine the nutritional status and micronutrient levels of hospitalized patients in an infectious disease clinic and investigate their association with adverse clinical outcomes. The nutritional status of the study participants was assessed using the Nutritional Risk Screening 2002 (NRS 2002) and micronutrient levels and routine biochemical parameters were tested within the first 24 h of the patient's admission. The incidence of zinc, selenium, thiamine, vitamin B6, vitamin B12 deficiency were 66.7% (n = 40), 46.6% (n = 29), 39.7% (n = 27), 35.3% (n = 24), 14.1% (n = 9), respectively. Selenium levels were significantly higher in patients with urinary tract infections, but lower in soft tissue infections. Copper levels were significantly higher in patients with soft tissue infections. In the Cox regression models, lower albumin, higher serum lactate dehydrogenase levels and higher NRS-2002 scores were associated with increased death. Thiamine, selenium, zinc and vitamin B6 deficiencies but not chromium deficiencies are common in infectious disease clinics. New associations were found between micronutrient levels and infection type and their adverse clinical outcomes. Hypoalbuminemia and a high NRS-2002 score had the greatest accuracy in predicting death, systemic inflammatory response syndrome and sepsis on admission. PMID:26938553

  1. Relationship between Illness Perceptions, Treatment Adherence, And Clinical Outcomes in Patients On Maintenance Hemodialysis

    PubMed Central

    Kim, Youngmee; Evangelista, Lorraine S.

    2011-01-01

    Previous data indicate that negative perception of disease and non-adherence to recommended treatment may lead to unfavorable clinical outcomes in patients on maintenance hemodialysis (HD). However, a paucity of research addresses clinical outcomes in the end stage renal disease (ESRD) population as a function of patients’ illness perceptions and their degree of adherence to recommended treatment. The study was conducted to examine illness perceptions and treatment adherence rates in patients on maintenance HD, and to determine if illness perceptions and adherence behaviors influence clinical outcomes. One hundred fifty-one patients completed the Revised Illness Perception Questionnaire and the ESRD-Adherence Questionnaire. Illness perceptions did not independently predict any clinical outcomes in patients on maintenance HD; however, specific adherence behaviors affected clinical outcomes. Therefore, strategies to enhance adherence should be rigorously pursued in this population to improve clinical outcomes. PMID:20629465

  2. Clinical Outcomes of 174 Nasopharyngeal Carcinoma Patients With Radiation-Induced Temporal Lobe Necrosis

    SciTech Connect

    Lam, Tai-Chung; Wong, Frank C.S.; Leung, To-Wai; Ng, S.H.; Tung, Stewart Y.

    2012-01-01

    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 receiving 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. Although

  3. Impact of bacterial coinfection on clinical outcomes in pneumococcal pneumonia.

    PubMed

    Kumagai, S; Ishida, T; Tachibana, H; Ito, Y; Ito, A; Hashimoto, T

    2015-09-01

    The aim of this study was to investigate the influence of bacterial coinfection on patients with pneumococcal pneumonia. We retrospectively analyzed the incidence, clinical features, microbial distributions, and outcomes of patients with bacterial coinfection in a cohort of 433 hospitalized patients with pneumococcal pneumonia. Eighty-five patients (19.6 %) were diagnosed with bacterial coinfection; the most frequent pathogens were Haemophilus influenzae (25 patients, 33.3 %), methicillin-susceptible Staphylococcus aureus (MSSA) (15 patients, 20.0 %), and Moraxella catarrhalis (13 patients, 17.3 %). The CURB-65 score and pneumonia severity index (PSI) were significantly higher in patients with bacterial coinfection (both P < 0.001). In addition, the proportion of patients with bacterial coinfection who met the Infectious Disease Society of America (IDSA)/American Thoracic Society (ATS) severe pneumonia criteria was significantly higher (P < 0.001). Multivariate logistic regression analysis identified three risk factors for bacterial coinfection in patients with pneumococcal pneumonia: alcoholism (odds ratio [OR], 5.12; 95 % confidence interval (95 % CI), 1.60-16.4; P = 0.006), hospitalization for 2 days or more within 90 days preceding admission (OR, 2.02; 95 % CI, 1.03-3.98; P = 0.041), and residence in a nursing home or extended care facility (OR, 3.22; 95 % CI, 1.48-6.97; P = 0.003). Multivariate analysis for 30-day mortality showed that bacterial coinfection was a significant adverse prognostic factor (OR, 2.50; 95 % CI, 1.13-5.53; P = 0.023), independent of IDSA/ATS severe pneumonia, PSI, or healthcare-associated pneumonia. In conclusion, bacterial coinfection may have an adverse impact on severity and outcomes of pneumococcal pneumonia. PMID:26059041

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

    PubMed

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

    2016-07-01

    Prothrombin complex concentrates (PCCs) are indicated for urgent reversal of warfarin and used for reversal of novel oral anticoagulants, in patients with acute major bleeding or need for an urgent procedure. The research goal was to evaluate effectiveness and safety outcomes with PCC usage at our institution. A retrospective review of electronic medical records identified patients that received a PCC commercially available in the United States (KCentra(®) or Profilnine(®)) at twelve hospitals in a tertiary care health system from July 1, 2013 to April 30, 2014. A total of 193 patients received PCC, of which 184 patients received four-factor PCC. The patient population was 48 % male and 75 % Caucasian, with a mean age of 73 years old. Clinical outcomes of interest included time to achieve a target INR ≤1.3, time to Hgb >7 g/dL, and incidence of thromboembolism. A total of 143 patients were on warfarin (74.1 %) at baseline, whereas 18 patients (9.3 %) were taking a novel anticoagulant. Target INR of ≤1.3 was achieved in 125 patients (65.8 %), within a median time of 8.03 h (IQR 3.38-34.07). Among patients with a baseline Hgb <7 g/L (n = 13), the median time to Hgb >7 g/dL was 8.48 h (IQR 6.95-13.00). Eight patients (4.1 %) developed an acute venous thromboembolism following PCC administration. INR reversal was achieved in approximately two-thirds of patients, with a low incidence of venous thromboembolism. Four-factor PCC is a viable alternative to plasma. PMID:26685667

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

    PubMed Central

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

    2016-01-01

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

  6. Bilateral Vitreous Hemorrhage in Children: Clinical Features and Outcomes

    PubMed Central

    Sudhalkar, Aditya; Chhablani, Jay; Rani, Padmaja Kumari; Jalali, Subhadra; Balakrishnan, Divya; Tyagi, Mudit

    2015-01-01

    Purpose: To determine the etiology, clinical features and outcomes of bilateral vitreous hemorrhage (VH) in children. Methods: This retrospective chart review was performed on patients with bilateral VH under the age of 18 at a tertiary eye care center in India. Data included demographics, details of history and ocular examination, reports of investigations, surgeries or other interventions performed, and final anatomical and visual outcomes. Patients were divided into two groups i.e., traumatic and non-traumatic (spontaneous). Results: The traumatic group was comprised of 37 patients including 27 male and 10 female subjects with mean age of 13.47 ± 5.31 years, the most common complaint was decreased vision (96.45%) and the most prevalent etiology was firecracker injury in 16 (43.2%) patients. Mean baseline visual acuity (VA) was 2.34 ± 1.31 logMAR which was significantly improved to 1.08 ± 0.23 logMAR (P = 0.042). The mean number of surgeries was 2.72 ± 1.43 in the traumatic VH and mean follow up period was 23.14 ± 6.54 months. The spontaneous group included 48 subjects comprised of 27 male and 21 female cases with mean age of 14.48 ± 2.03 years. The most common cause was vasculitis in 21 (43.75%) subjects including four patients with tuberculosis. Mean baseline VA was 1.97 ± 1.13 logMAR which showed a significant improvement to 0.82 ± 0.24 logMAR (P = 0.012) after mean follow up of 34.2 ± 11.2 months. Eleven patients required at least one major surgery. Conclusion: Vasculitis was the most common cause of spontaneous bilateral VH; traumatic VH most prevalently occurred due to firecracker injury. Final VA was better in the spontaneous group. PMID:26425315

  7. Robotic-Assisted Versus Laparoscopic Colectomy: Cost and Clinical Outcomes

    PubMed Central

    Davis, Bradley R.; Yoo, Andrew C.; Moore, Matt

    2014-01-01

    Background and Objectives: Laparoscopic colectomies, with and without robotic assistance, are performed to treat both benign and malignant colonic disease. This study compared clinical and economic outcomes for laparoscopic colectomy procedures with and without robotic assistance. Methods: Patients aged ≥18 years having primary inpatient laparoscopic colectomy procedures (cecectomy, right hemicolectomy, left hemicolectomy, and sigmoidectomy) identified by International Classification of Diseases, Ninth Edition procedure codes performed between 2009 and the second quarter of 2011 from the Premier Hospital Database were studied. Patients were matched to a control cohort using propensity scores for disease, comorbidities, and hospital characteristics and were matched 1:1 for specific colectomy procedure. The outcomes of interest were hospital cost of laparoscopic robotic-assisted colectomy compared with traditional laparoscopic colectomy, surgery time, adverse events, and length of stay. Results: Of 25 758 laparoscopic colectomies identified, 98% were performed without robotic assistance and 2% were performed with robotic assistance. After matching, 1066 patients remained, 533 in each group. Lengths of stay were not significantly different between the matched cohorts, nor were rates of major, minor, and/or surgical complications. Inpatient procedures with robotic assistance were significantly more costly than those without robotic assistance ($17 445 vs $15 448, P = .001). Operative times were significantly longer for robotic-assisted procedures (4.37 hours vs 3.34 hours, P < .001). Conclusion: Segmental colectomies can be performed safely by either laparoscopic or robotic-assisted methods. Increased per-case hospital costs for robotic-assisted procedures and prolonged operative times suggest that further investigation is warranted when considering robotic technology for routine laparoscopic colectomies. PMID:24960484

  8. Clinical attributes and surgical outcomes of angiocentric gliomas.

    PubMed

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

    2016-06-01

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

  9. Snoezelen Room and Childbirth Outcome: A Randomized Clinical Trial

    PubMed Central

    Jamshidi Manesh, Mansoureh; Kalati, Mahnaz; Hosseini, Fatemeh

    2015-01-01

    Background: One of the strategies for a good outcome and pain free childbearing is to design the delivery room. Objectives: The aim of this study was to evaluate the effects of snoezelen room on childbearing outcome such as pain intensity, duration of labor, and perinea status in nulliparous women. Patients and Methods: This study was a randomized controlled clinical trial consists of 100 childbearing women. They were randomly divided into 2 groups. The experimental group went to snoezelen room when their cervix dilation was 4 cm, while the control group went to physiologic delivery room with the same cervix dilation. Results: The mean ± SD of VAS (Visual Analogue Scale) pain intensity of the experimental and control groups before the intervention were 5.1 ± 1.95 and 5.58 ± 1.62, respectively (P = 0.13). The mean ± SD of VAS pain intensity scores of the experimental and control groups after 3 hours spending in their assigned rooms were 5.26 ± 0.86 and 9.56 ± 1.48, respectively (P = 0.01). The mean ± SD of the first stage scores of the experimental and control groups were 6.95 ± 0.97 and 8.41 ± 0.67, respectively (P = 0.042). About 92% of participants’ intervention vs. 66% of control participants had perinea laceration (P = 0.041). Conclusions: According to the findings of the present study, distracting senses in snoezelen room decreases mother’s pain intensity, the length of labor, and incidence of episiotomy. PMID:26082849

  10. Clinical Characteristics and Surgical Outcomes in Patients With Intermittent Exotropia

    PubMed Central

    Yang, Min; Chen, Jingchang; Shen, Tao; Kang, Ying; Deng, Daming; Lin, Xiaoming; Wu, Heping; Chen, Qiwen; Ye, Xuelian; Li, Jianqun; Yan, Jianhua

    2016-01-01

    Abstract The clinical characteristics and surgical outcomes in a large sample of patients with intermittent exotropia (IXT) as well as an analysis of risk factors associated with surgical failures are presented in this article. Data from IXT patients who received surgical management at the Eye Hospital, in the Zhongshan Ophthalmic Center, of Sun Yat-Sen University, China from January 2009 to December 2013 were reviewed retrospectively. Included within this analysis were data from pre- and postoperative ocular motility, primary alignment, and binocular vision. A total of 1228 patients with IXT were reviewed. Males (50.4%) and females (49.6%) were nearly equally represented in this sample. Thirty-two patients (2.6%) had a family history of strabismus. The mean age at onset was 6.77 ± 6.43 years (range 7 months –48.5 years), mean duration at presentation was 7.35 ± 6.68 years (range 6 months–47 years), and mean age at surgery was 13.7 ± 8.8 years (range 3–49 years). The mean refractive error was −0.84 ± 2.69 diopter in the right eye and −0.72 ± 2.58 diopter in the left eye. Amblyopia (4.2%), oblique muscle dysfunction (7.0%), and dissociated vertical deviation (4.7%) were also present in these patients. The most common subtype of IXT was the basic type (88.1%). Orthophoria was observed in 80.5% of patients and the ratios of surgical undercorrection and overcorrection were 14.7% and 4.8%, respectively, as determined with a mean follow-up time of 7.8 ± 3.7 months. When combining ocular alignment with binocular vision as the success criteria, the success rate decreased to 35.6%. Multivariate risk factor analysis showed that only the loss of stereoacuity (P = 0.002) was associated with a poor outcome. There were no differences in the long-term results between bilateral lateral rectus recession and unilateral lateral rectus recession with medial rectus resection. Most IXT patients displayed normal vision, with few having positive

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

    PubMed Central

    Khoshkhounejad, Mehrfam; Shokouhinejad, Noushin

    2015-01-01

    Endodontic intervention in necrotic immature permanent teeth is usually a clinical challenge. With appropriate case selection, regenerative treatment can be effective, providing a desirable outcome. However, there is still no consensus on the optimal disinfection protocol or the method to achieve predictable clinical outcome. This article presents two cases of regenerative treatment in necrotic immature teeth, using mineral trioxide aggregate (MTA) and BiodentineTM as coronal barriers and different irrigants, which led to different clinical outcomes. PMID:26884781

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

    PubMed

    Khoshkhounejad, Mehrfam; Shokouhinejad, Noushin; Pirmoazen, Salma

    2015-06-01

    Endodontic intervention in necrotic immature permanent teeth is usually a clinical challenge. With appropriate case selection, regenerative treatment can be effective, providing a desirable outcome. However, there is still no consensus on the optimal disinfection protocol or the method to achieve predictable clinical outcome. This article presents two cases of regenerative treatment in necrotic immature teeth, using mineral trioxide aggregate (MTA) and Biodentine(TM) as coronal barriers and different irrigants, which led to different clinical outcomes. PMID:26884781

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

    PubMed Central

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

    2016-01-01

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

  14. Intradialytic Hypoxemia and Clinical Outcomes in Patients on Hemodialysis

    PubMed Central

    Meyring-Wösten, Anna; Zhang, Hanjie; Ye, Xiaoling; Fuertinger, Doris H.; Chan, Lili; Kappel, Franz; Artemyev, Mikhail; Ginsberg, Nancy; Wang, Yuedong; Thijssen, Stephan

    2016-01-01

    Background and objectives Intradialytic hypoxemia has been recognized for decades, but its associations with outcomes have not yet been assessed in a large patient cohort. Design, setting, participants, & measurements Our retrospective cohort study was conducted between January of 2012 and January of 2015. We recorded blood oxygen saturation every minute during hemodialysis in patients with arteriovenous access. A 6-month baseline period with at least 10 treatments with oxygen saturation measurements preceded a 12-month follow-up. Patients were stratified by the presence or absence of prolonged intradialytic hypoxemia defined as oxygen saturation <90% for at least one third of the treatment time. Demographic, laboratory, and treatment data and hospitalization and mortality rates were compared between the groups. Multivariate Cox regression analysis was used to assess baseline predictors of all-cause mortality during follow-up. Results In total, 100 (10%) of 983 patients had prolonged intradialytic hypoxemia. These patients were older (+3.6 years; 95% confidence interval, 0.8 to 6.3), had longer dialysis vintage (+1.2 years; 95% confidence interval, 0.3 to 2.1), and had higher prevalence of congestive heart failure (+10.8%; 95% confidence interval, 1.6 to 20.7) and chronic obstructive pulmonary disease (+13%; 95% confidence interval, 5 to 21.2). They also resembled an inflammatory phenotype, with lower serum albumin levels (−0.1 g/dl; 95% confidence interval, −0.2 to 0) and higher neutrophil-to-lymphocyte ratios (+1; 95% confidence interval, 0.5 to 1.6). They had lower hemoglobin levels (−0.2 g/dl; 95% confidence interval, −0.4 to 0) and required more erythropoietin (+1374 U per hemodialysis treatment; 95% confidence interval, 343 to 2405). During follow-up, all-cause hospitalization (1113 hospitalizations; univariate hazard ratio, 1.46; 95% confidence interval, 1.22 to 1.73) and mortality (89 deaths; adjusted hazard ratio, 1.98; 95% confidence interval, 1

  15. Prospective Analysis of a New Bone Graft in Lumbar Interbody Fusion: Results of a 2- Year Prospective Clinical and Radiological Study

    PubMed Central

    Raskin, Yannic

    2015-01-01

    Background This study examined the efficacy and safety of bone graft material ABM/P-15 (iFACTOR) for use in posterior lumbar interbody fusion. ABM/P-15 has been used safely for more than a decade in dental applications. Methods Forty patients underwent PLIF surgery, with each patient as control. Assessments up to 24 months included radiographs, CT scan, VAS, and ODI. Primary success criteria were fusion and safety. Results Intra-cage bridging bone occurred earlier with ABM/P-15 than autograft (97.73% vs. 59.09% at 6 months). On average pain decreased 29 points and function improved 43 points. Radio dense material outside the disk space occurred more frequently with ABM/P-15 than autograft, without clinical consequence. Conclusions This study suggests that ABM/P-15 has equal or greater efficacy at 6 and 12 months. Pain improvements exceeded success criteria at all time points. Functional improvement exceeded success criteria at all time points. Clinical Relevance This study explores the safety and efficacy of an osteobiologic peptide enhanced bone graft material as a viable alternative to autograft and its attendant risks. PMID:25709887

  16. Long-term clinical outcomes following 3- and 4-level anterior cervical discectomy and fusion.

    PubMed

    De la Garza-Ramos, Rafael; Xu, Risheng; Ramhmdani, Seba; Kosztowski, Thomas; Bydon, Mohamad; Sciubba, Daniel M; Wolinsky, Jean-Paul; Witham, Timothy F; Gokaslan, Ziya L; Bydon, Ali

    2016-06-01

    OBJECTIVE The purpose of this study was to report the long-term clinical outcomes following 3- and 4-level anterior cervical discectomy and fusion (ACDF). METHODS A retrospective review of all adult neurosurgical patients undergoing elective ACDF for degenerative disease at a single institution between 1996 and 2013 was performed. Patients who underwent first-time 3- or 4-level ACDF were included; patients with previous cervical spine surgery, those undergoing anterior/posterior approaches, and those with corpectomy were excluded. Outcome measures included perioperative complication rates, fusion rates, need for revision surgery, Nurick Scores, Odom's criteria, symptom resolution, neck visual analog scale (VAS) pain score, and persistent narcotics usage. RESULTS Seventy-one patients who underwent 3-level ACDF and 26 patients who underwent 4-level ACDF were identified and followed for an average of 7.6 ± 4.2 years. There was 1 case (3.9%) of deep wound infection in the 4-level group and 1 case in the 3-level group (1.4%; p = 0.454). Postoperatively, 31% of patients in the 4-level group complained of dysphagia, compared with 12.7% in the 3-level group (p = 0.038). The fusion rate was 84.6% after 4-level ACDF and 94.4% after 3-level ACDF (p = 0.122). At last follow-up, a significantly higher proportion of patients in the 4-level group continued to have axial neck pain (53.8%) than in the 3-level group (31%; p = 0.039); the daily oral morphine equivalent dose was significantly higher in the 4-level group (143 ± 97 mg/day) than in the 3-level group (25 ± 10 mg/day; p = 0.030). Outcomes based on Odom's criteria were also different between cohorts (p = 0.044), with a significantly lower proportion of patients in the 4-level ACDF group experiencing an excellent/good outcome. CONCLUSIONS In this study, patients who underwent 4-level ACDF had significantly higher rates of dysphagia, postoperative neck pain, and postoperative narcotic usage when compared with patients who

  17. Clinical Features and Outcome of Patients With IRAK-4 and MyD88 Deficiency

    PubMed Central

    Picard, Capucine; von Bernuth, Horst; Ghandil, Pegah; Chrabieh, Maya; Levy, Ofer; Arkwright, Peter D.; McDonald, Douglas; Geha, Raif S.; Takada, Hidetoshi; Krause, Jens C.; Creech, C. Buddy; Ku, Cheng-Lung; Ehl, Stephan; Maŕodi, Ĺaszĺo; Al-Muhsen, Saleh; Al-Hajjar, Sami; Al-Ghonaium, Abdulaziz; Day-Good, Noorbibi K.; Holland, Steven M.; Gallin, John; Chapel, Helen; Speert, David P.; Rodriguez-Gallego, Carlos; Colino, Elena; Garty, Ben-Zion; Roifman, Chaim; Hara, Toshiro; Yoshikawa, Hideto; Nonoyama, Shigeaki; Domachowske, Joseph; Issekutz, Andrew C.; Tang, Mimi; Smart, Joanne; Zitnik, Simona Eva; Hoarau, Cyrille; Kumararatne, Dinakantha; Thrasher, Adrian; Davies, E. Graham; Bethune, Claire; Sirvent, Nicolas; de Ricaud, Dominique; Camcioglu, Yildiz; Vasconcelos, J́ulia; Guedes, Margarida; Vitor, Artur Bonito; Rodrigo, Carlos; AlmaŸan, Francisco; Ḿendez, Maria; Aŕostegui, Juan Ignacio; Alsina, Laia; Fortuny, Claudia; Reichenbach, Janine; Verbsky, James W; Bossuyt, Xavier; Doffinger, Rainer; Abel, Laurent; Puel, Anne; Casanova, Jean-Laurent

    2011-01-01

    Autosomal recessive interleukin-1 receptor-associated kinase (IRAK)-4 and myeloid differentiation factor (MyD)88 deficiencies impair Toll-like receptor (TLR)- and interleukin-1 receptor-mediated immunity. We documented the clinical features and outcome of 48 patients with IRAK-4 deficiency and 12 patients with MyD88 deficiency, from 37 kindreds in 15 countries. The clinical features of IRAK-4 and MyD88 deficiency were indistinguishable. There were no severe viral, parasitic, and fungal diseases, and the range of bacterial infections was narrow. Noninvasive bacterial infections occurred in 52 patients, with a high incidence of infections of the upper respiratory tract and the skin, mostly caused by Pseudomonas aeruginosa and Staphylococcus aureus, respectively. The leading threat was invasive pneumococcal disease, documented in 41 patients (68%) and causing 72 documented invasive infections (52.2%). P. aeruginosa and Staph. aureus documented invasive infections also occurred (16.7% and 16%, respectively, in 25% and 25% of patients). Systemic signs of inflammation were usually weak or delayed. The first invasive infection occurred before the age of 2 years in 53 (88.3%) and in the neonatal period in 19 (32.7%) patients. Multiple or recurrent invasive infections were observed in most survivors (n = 36/50, 72%). PMID:21057262

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

    PubMed Central

    2010-01-01

    Background Traditional peripheral biofeedback has grade A evidence for effectively treating migraines. Two newer forms of neurobiofeedback, EEG biofeedback and hemoencephalography biofeedback were combined with thermal handwarming biofeedback to treat 37 migraineurs in a clinical outpatient setting. Methods 37 migraine patients underwent an average of 40 neurofeedback sessions combined with thermal biofeedback in an outpatient biofeedback clinic. All patients were on at least one type of medication for migraine; preventive, abortive or rescue. Patients kept daily headache diaries a minimum of two weeks prior to treatment and throughout treatment showing symptom frequency, severity, duration and medications used. Treatments were conducted an average of three times weekly over an average span of 6 months. Headache diaries were examined after treatment and a formal interview was conducted. After an average of 14.5 months following treatment, a formal interview was conducted in order to ascertain duration of treatment effects. Results Of the 37 migraine patients treated, 26 patients or 70% experienced at least a 50% reduction in the frequency of their headaches which was sustained on average 14.5 months after treatments were discontinued. Conclusions All combined neuro and biofeedback interventions were effective in reducing the frequency of migraines with clients using medication resulting in a more favorable outcome (70% experiencing at least a 50% reduction in headaches) than just medications alone (50% experience a 50% reduction) and that the effect size of our study involving three different types of biofeedback for migraine (1.09) was more robust than effect size of combined studies on thermal biofeedback alone for migraine (.5). These non-invasive interventions may show promise for treating treatment-refractory migraine and for preventing the progression from episodic to chronic migraine. PMID:20205867

  19. Systematic review of clinical outcomes after prophylactic surgery.

    PubMed

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

    2016-07-01

    Introduction Prophylactic appendicectomy is performed prior to military, polar and space expeditions to prevent acute appendicitis in the field. However, the risk-benefit ratio of prophylactic surgery is controversial. This study aimed to systematically review the evidence for prophylactic appendicectomy. It is supplemented by a clinical example of prophylactic surgery resulting in life-threatening complications. Methods A systematic review was performed using MEDLINE(®) and the Cochrane Central Register of Controlled Trials. Keyword variants of 'prophylaxis' and 'appendicectomy' were combined to identify potential papers for inclusion. Papers related to prophylactic appendicectomy risks and benefits were reviewed. Results Overall, 511 papers were identified, with 37 papers satisfying the inclusion criteria. Nine reported outcomes after incidental appendicectomy during concurrent surgical procedures. No papers focused explicitly on prophylactic appendicectomy in asymptomatic patients. The clinical example outlined acute obstruction secondary to adhesions from a prophylactic appendicectomy. Complications after elective appendicectomy versus the natural history of acute appendicitis in scenarios such as polar expeditions or covert operations suggest prophylactic appendicectomy may be appropriate prior to extreme situations. Nevertheless, the long-term risk of adhesion related complications render prophylactic appendicectomy feasible only when the short-term risk of acute appendicitis outweighs the long-term risks of surgery. Conclusions Prophylactic appendicectomy is rarely performed and not without risk. This is the first documented evidence of long-term complications following prophylactic appendicectomy. Surgery should be considered on an individual basis by balancing the risks of acute appendicitis in the field with the potential consequences of an otherwise unnecessary surgical procedure in a healthy patient. PMID:27023639

  20. Proton Radiotherapy for Pediatric Ewing's Sarcoma: Initial Clinical Outcomes

    SciTech Connect

    Rombi, Barbara; DeLaney, Thomas F.; MacDonald, Shannon M.; Huang, Mary S.; Ebb, David H.; Liebsch, Norbert J.; Raskin, Kevin A.; Yeap, Beow Y.; Marcus, Karen J.; Tarbell, Nancy J.; Yock, Torunn I.

    2012-03-01

    Purpose: Proton radiotherapy (PT) has been prescribed similarly to photon radiotherapy to achieve comparable disease control rates at comparable doses. The chief advantage of protons in this setting is to reduce acute and late toxicities by decreasing the amount of normal tissue irradiated. We report the preliminary clinical outcomes including late effects on our pediatric Ewing's sarcoma patients treated with PT at the Francis H. Burr Proton Therapy Center at Massachusetts General Hospital (Boston, MA). Methods and Materials: This was a retrospective review of the medical records of 30 children with Ewing's sarcoma who were treated with PT between April 2003 and April 2009. Results: A total of 14 male and 16 female patients with tumors in several anatomic sites were treated with PT at a median age of 10 years. The median dose was 54 Gy (relative biological effectiveness) with a median follow-up of 38.4 months. The 3-year actuarial rates of event-free survival, local control, and overall survival were 60%, 86%, and 89%, respectively. PT was acutely well tolerated, with mostly mild-to-moderate skin reactions. At the time of writing, the only serious late effects have been four hematologic malignancies, which are known risks of topoisomerase and anthracyline exposure. Conclusions: Proton radiotherapy was well tolerated, with few adverse events. Longer follow-up is needed to more fully assess tumor control and late effects, but the preliminary results are encouraging.

  1. Clinical outcomes and mortality in elderly peritoneal dialysis patients

    PubMed Central

    Sakacı, Tamer; Ahbap, Elbis; Koc, Yener; Basturk, Taner; Ucar, Zuhal Atan; Sınangıl, Ayse; Sevınc, Mustafa; Kara, Ekrem; Akgol, Cuneyt; Kayalar, Arzu Ozdemır; Caglayan, Feyza Bayraktar; Sahutoglu, Tuncay; Ünsal, Abdulkadir

    2015-01-01

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

  2. Mealtime problems predict outcome in clinical trial to improve nutrition in children with CF.

    PubMed

    Opipari-Arrigan, Lisa; Powers, Scott W; Quittner, Alexandra L; Stark, Lori J

    2010-01-01

    Better growth and nutritional status is strongly associated with better pulmonary function and survival in children with CF. Behavioral intervention is an efficacious treatment approach for improving calorie intake and weight gain in children with CF; and recently has been shown to facilitate maintenance of daily energy intake at 120% of the healthy population over a 2-year period. However, no study to date has examined factors that predict outcome with behavior intervention to promote weight gain in CF. The objectives of this study were to examine the influence of nutritional status, mealtime behavior problems, and maternal depressive symptoms on calorie intake and weight gain following participation in a randomized trial to improve nutritional status in cystic fibrosis. Sixty-seven children, aged 4-12 years with cystic fibrosis participated in a clinical trial targeting calorie and weight increases. Participants completed baseline measures of mealtime behavior problems, maternal depression, and fat absorption, and baseline and post-treatment caloric intake and weight. Assignment to behavioral group (R(2) change = 0.17), lower frequency of mealtime behavior problems (R(2) change = 0.11), and higher maternal depression (R(2) change = 0.06) predicted greater calorie increase baseline to post-treatment. Assignment to behavioral group (R(2) change = 0.09), higher baseline weight (R(2) change = 0.10), fat absorption (R(2) change = 0.02), and lower frequency of mealtime behavior problems (R(2) change = 0.06) predicted greater weight gain baseline to post-treatment. Less frequent mealtime behavior problems led to better calorie intake and weight gain in a 9-week clinical trial of behavior intervention and nutrition education to improve nutritional status in cystic fibrosis. The key implication from these findings is that early referral to behavioral intervention as soon as growth deficits become a concern will likely yield the best nutritional outcomes. PMID:19953660

  3. Exposure of Prebiopsy Antibiotics Influence Bacteriological Diagnosis and Clinical Outcomes in Patients With Infectious Spondylitis

    PubMed Central

    Wang, Ying-Chih; Wong, Chak-Bor; Wang, I-Chun; Fu, Tsai-Sheng; Chen, Lih-Huei; Chen, Wen-Jer

    2016-01-01

    Abstract The benefit of prebiopsy empirical antibiotics for patients with infectious spondylitis and the effect on clinical outcome are not well known. This study assessed the impact of prebiopsy empirical antibiotics in patients with infectious spondylitis. We retrospectively reviewed 41 adult in-patients with infectious spondylitis who received percutaneous endoscopic debridement and drainage (PEDD) at a tertiary care hospital from August 2002 to August 2012. The average patient age was 55.2 years old and causative bacteria were identified in 32 out of 41 biopsy specimens (78.0%) via the PEDD procedure, which has good diagnostic efficacy comparable to open biopsy. Seventeen patients (41.5%) received prebiopsy empirical antimicrobial therapy, and these patients were less likely to have positive cultures than those who did not receive preoperative antibiotics (64.7% vs 87.5%, P = 0.04). Patients with positive cultures had a better infection control rate (78.1% vs 67.7%) and were less likely to undergo subsequent open surgery. Patients given preoperative antibiotics were more likely to need subsequent open surgery (35.3% vs 16.7%, P = 0.02). From multivariate logistic analysis showed age at diagnosis to be an independent risk factor for the need of further surgery. There were no major complications following the PEDD procedure, except 2 patients had transient paresthesia in the affected lumbar segments. Prebiopsy empirical antibiotic therapy was associated with lower positive culture rate and an increased need for subsequent open surgery. Patients with positive cultures were more likely to have initially adequate treatment, better infection control, and better clinical outcome. PMID:27082590

  4. Clinical Outcomes of Patients Receiving Integrated PET/CT-Guided Radiotherapy for Head and Neck Carcinoma

    SciTech Connect

    Vernon, Matthew R.; Maheshwari, Mohit; Schultz, Christopher J.; Michel, Michelle A.; Wong, Stuart J.; Campbell, Bruce H.; Massey, Becky L.; Wilson, J. Frank; Wang Dian

    2008-03-01

    Purpose: We previously reported the advantages of {sup 18}F-fluorodeoxyglucose-positron emission tomography (PET) fused with CT for radiotherapy planning over CT alone in head and neck carcinoma (HNC). The purpose of this study was to evaluate clinical outcomes and the predictive value of PET for patients receiving PET/CT-guided definitive radiotherapy with or without chemotherapy. Methods and Materials: From December 2002 to August 2006, 42 patients received PET/CT imaging as part of staging and radiotherapy planning. Clinical outcomes including locoregional recurrence, distant metastasis, death, and treatment-related toxicities were collected retrospectively and analyzed for disease-free and overall survival and cumulative incidence of recurrence. Results: Median follow-up from initiation of treatment was 32 months. Overall survival and disease-free survival were 82.8% and 71.0%, respectively, at 2 years, and 74.1% and 66.9% at 3 years. Of the 42 patients, seven recurrences were identified (three LR, one DM, three both LR and DM). Mean time to recurrence was 9.4 months. Cumulative risk of recurrence was 18.7%. The maximum standard uptake volume (SUV) of primary tumor, adenopathy, or both on PET did not correlate with recurrence, with mean values of 12.0 for treatment failures vs. 11.7 for all patients. Toxicities identified in those patients receiving intensity modulated radiation therapy were also evaluated. Conclusions: A high level of disease control combined with favorable toxicity profiles was achieved in a cohort of HNC patients receiving PET/CT fusion guided radiotherapy plus/minus chemotherapy. Maximum SUV of primary tumor and/or adenopathy was not predictive of risk of disease recurrence.

  5. Transjugular intrahepatic portosystemic shunting (TIPS) with balloon-expandable and self-expanding stents: Technical and clinical aspects after 3 1/2 years' experience

    SciTech Connect

    Tesdal, I. Kaare; Jaschke, Werner; Buehler, Mathias; Adamus, Ralf; Filser, Thomas; Holm, Eggert; Georgi, Max

    1997-01-15

    Purpose. To evaluate prospectively our experience with transjugular intrahepatic portosystemic shunt (TIPS) using four different metallic stents. Methods. Between November 1991 and April 1995, 57 patients (41 men and 16 women; age 35-72 years, mean 54 years) underwent the TIPS procedure. Techniques for portal vein localization before and during TIPS were fluoroscopy, computed tomography (CT) studies, wedged hepatic venography, arterial portography, and ultrasound. After predilation we deployed balloon-expandable (n=48) and self-expanding (n=45) metallic stents. Fifteen patients underwent variceal embolization. Initial follow-up angiograms (mean 6.9 months, range 3-24 months) were obtained in 39 of these patients. Results. Fifty-three patients (93%) had successful TIPS placement. The mean decrease in portal pressure was 42.7%. Besides fluoroscopy, the most helpful techniques for portal vein localization were venography and CT. Residual stenosis (n=1) and late shortening (n=4) of Wallstents resulted in shunt dysfunction. The technical problems encountered with the Palmaz stent resulted from its lack of flexibility. We combined balloon-expandable and self-expanding stents in 12 patients. The 30-day and late follow-up (mean 11.9 months) percutaneous reintervention rates were 11.3% and 64.2%, respectively. There were no clinically significant complications related to the TIPS insertions. Conclusion. An ideal stent does not exist for TIPS, and the authors recommend combining a Palmaz stent with a flexible self-expanding stent.

  6. Clinical, virologic, histologic, and biochemical outcomes after successful HCV therapy

    PubMed Central

    George, Sarah L.; Bacon, Bruce R.; Brunt, Elizabeth M.; Mihindukulasuriya, Kusal L.; Hoffmann, Joyce; Di Bisceglie, Adrian M.

    2009-01-01

    One hundred and fifty patients with sustained virologic response (SVR) after treatment of chronic hepatitis C were enrolled in a long-term clinical follow-up study; patients were followed for 5 years for liver-related outcomes and evidence of biochemical or virologic relapse. Patients with stage two or greater fibrosis on pre-treatment biopsy were invited to undergo a long-term follow-up biopsy after their 4th year of follow-up. One hundred twenty-eight patients (85%) were followed through their 4th year and long-term follow-up biopsies were obtained from 60 patients (40%). Forty-nine patients had paired pre-treatment and long-term follow-up biopsies blindly rescored. Forty of these (82%) had a decrease in fibrosis score and forty-five (92%) had a decrease in combined inflammation score. Ten patients (20%) had normal or nearly normal livers on long-term follow-up biopsy. Two patients with pre-treatment cirrhosis developed hepatocellular carcinoma (HCC) and one died. All the other patients with pre-treatment cirrhosis or advanced fibrosis had improved fibrosis scores on long-term follow-up biopsy. No patient had conclusive evidence of virologic relapse. Three patients had persistently elevated alanine aminotransferase (ALT) levels; two of these had new liver disease. In conclusion, in this cohort of 150 patients with SVR followed for five years the majority of patients had good outcomes. Serum virologic relapse was not seen but two patients with pre-treatment cirrhosis developed HCC and one died. In blind rescoring of forty-nine paired pre-treatment and long-term follow-up biopsies 82% improved fibrosis scores and 92% improved at least one component of inflammation. A minority of patients had normal or nearly normal liver tissue on long-term follow-up biopsy. Patients with cirrhosis pre-treatment are at a low but real risk of HCC after SVR. PMID:19072828

  7. Long-term ECG in ambulatory clinical practice. Analysis and 2-year follow-up of 100 patients studied with a portable ECG tape recorder.

    PubMed

    Johansson, B W

    1977-01-01

    A portable tape recorder for long-term ECG monitoring is described. Its light weight (500 g) and small size (138 X 115 X 39 mm) make its usage in routine clinical practice a practical proposition. The most important application has been in the differential diagnosis of Adams--Strokes syndrome. The results from the first 100 patients with a 2-yr follow-up are presented. The importance of GCG recording during the patients' relevant subjective symptoms is stressed. The mean duration of recording was 2.8 days. In the 28 patients with histories which fitted the symptoms of Adams--Stokes syndrome this diagnosis was confirmed by an arrhythmia recorded simultaneously with the symptoms. In 36 other patients with a similar history the diagnosis was excluded becase of a normal ECG during subjective symptoms. Of the 28 patients with Adams--Stokes sydrome, bradyarrhthmia was the causal factor in 20 patients and these had a pacemaker implanted, whereas the remaining 8 patients had a tachyarrhythmia, which wa treated with antiarrhythmic drugs. The 2-yrs follow-up revealed an improvement and a disappearance of the Adams--Stokes attack in all the patients with an implanted pacemaker. In several of the 36 patients in whom Adams--Stokes syndrome could not be confirmed the syncopal attacks disappeared spontaneously. A large number of arrhythmias, including ventricular and supraventricular tachycardia, 2nd degree AV block and sinus bradycardia were observed during symptom-free intervals in these 36 patients. The introduction of long-term ECG recording routinely in patients with dizziness and syncope of unknown reason has resulted in an increase of the number of patients with a confirmed diagnosis of the Adams--Stokes syndrome, and it has contributed to an increase in the incidence of pacemaker implantation in Malmö from 130 per million inhabitants in 1971 to 220 in 1973, and 1974, respectively. PMID:837958

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

    PubMed

    Kvist, T

    2001-01-01

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

  9. Obstructive sleep apnea affects the clinical outcomes of patients undergoing percutaneous coronary intervention

    PubMed Central

    Zhang, Jun-jie; Gao, Xiao-fei; Ge, Zhen; Jiang, Xiao-Min; Xiao, Ping-xi; Tian, Nai-liang; Kan, Jing; Lee, Chi-Hang; Chen, Shao-Liang

    2016-01-01

    Background There is a paucity of evidence regarding the association between obstructive sleep apnea (OSA) and patients undergoing percutaneous coronary intervention (PCI) for coronary artery disease. We sought to investigate whether OSA affects the clinical outcomes of patients undergoing PCI. Patients and methods All enrolled individuals treated with PCI were evaluated for OSA by polysomnography. The primary end point was defined as major adverse cardiac events (MACEs) at 2 years, including cardiac death, myocardial infarction (MI), and/or target vessel revascularization. Results A total of 340 consecutive patients undergoing PCI were assigned to the OSA (n=152, apnea–hypopnea index ≥15) and non-OSA (n=188, apnea–hypopnea index <15) groups. The incidence of OSA in patients with coronary artery disease undergoing PCI was 44.7%. Patients in the OSA group had more three-vessel disease (34.9%), increased number of total implanted stents (3.3±2.0), and longer total stent length (83.8±53.1 mm) when compared to the non-OSA group (23.4%, P=0.020; 2.8±1.9, P=0.007; 68.7±48.4, P=0.010). After a median follow-up of 2 years, the incidence of MACEs was significantly higher in patients with OSA (25.0% vs 16.0%, P=0.038), mainly driven by the increased periprocedural MI (19.2% vs 11.2%, P=0.038) in the OSA group. By Cox regression multivariable analysis, the independent predictor of MACEs was OSA (hazard ratio: 1.962, 95% confidence interval: 1.036–3.717, P=0.039). Conclusion There was a high prevalence of moderate-to-severe OSA in patients undergoing PCI, and OSA was associated with significantly increased MACE rate, mainly due to the increase in periprocedural MI rate. PMID:27284240

  10. Cerebellopontine angle epidermoid cysts: clinical presentations and surgical outcome.

    PubMed

    Hasegawa, Mitsuhiro; Nouri, Mohsen; Nagahisa, Shinya; Yoshida, Koichiro; Adachi, Kazuhide; Inamasu, Joji; Hirose, Yuichi; Fujisawa, Hironori

    2016-04-01

    Epidermoid cysts constitute less than 1 % of intracranial tumors with the majority of them involving cerebellopontine angle (CPA). Although several mechanisms for cranial nerve dysfunction due to these tumors have been proposed, no direct evaluation for hyper- or hypoactive dysfunction has been done. In this case series, pathophysiology of cranial nerve dysfunction in CPA epidermoid cysts was evaluated with special attention to a new mechanism of capsule strangulation caused by stratified tumor capsule. Twenty-two cases with epidermoid cysts of CPA micro-neurosurgically treated in our departments since 2005 were reviewed. Clinical status of the patients before the surgery and post-operative functional outcome were recorded. Available data from the English literature were summarized for comparison. Mass reduction of cyst contents in most cases was usually associated with prompt and marked improvement of the symptoms suggesting neuroapraxia caused by compression of the tumor content and/or mild ischemia. Among them, two cases showed strangulation of the affected nerves by the tumor capsule whose preoperative dysfunction did not improve after surgery in spite of meticulous microsurgical removal of the lesion. Involved facial and abducent nerves in these two cases showed distortion of nerve axis and nerve atrophy distal to the strangulation site. We report the first direct evidence of etiology of cranial nerve dysfunction caused by cerebellopontine angle epidermoid tumors. Young age and rapidly progressive neurological deficit might be the characteristics for strangulation of the affected nerves by the cyst capsule. Even though the number of cases might be limited, immediate decompression and release of the strangulating band might be urged in such patients to prevent irreversible deficits. PMID:26566990

  11. Surgical Treatment and Clinical Outcome of Nonfunctional Pancreatic Neuroendocrine Tumors

    PubMed Central

    Yang, Min; Zeng, Lin; Zhang, Yi; Su, An-ping; Yue, Peng-ju; Tian, Bo-le

    2014-01-01

    Abstract Our primary aim of the present study was to analyze the clinical characteristics and surgical outcome of nonfunctional pancreatic neuroendocrine tumors (non-F-P-NETs), with an emphasis on evaluating the prognostic value of the newly updated 2010 grading classification of the World Health Organization (WHO). Data of 55 consecutive patients who were surgically treated and pathologically diagnosed as non-F-P-NETs in our single institution from January 2000 to December 2013 were retrospectively collected. This entirety comprised of 55 patients (31 males and 24 females), with a mean age of 51.24 ± 12.95 years. Manifestations of non-F-P-NETs were nonspecific. Distal pancreatectomy, pancreaticoduodenectomy, and local resection of pancreatic tumor were the most frequent surgical procedures, while pancreatic fistula was the most common but acceptable complication (30.3%). The overall 5-year survival rate of this entire cohort was 41.0%, with a median survival time of 60.4 months. Patients who underwent R0 resections obtained a better survival than those who did not (P < 0.005). As for the prognostic analysis, tumor size and lymph invasion were only statistically significant in univariate analysis (P = 0.046 and P < 0.05, respectively), whereas the newly updated 2010 grading classification of WHO (G1 and G2 vs G3), distant metastasis, and surgical margin were all meaningful in both univariate and multivariate analysis (P = 0.045, 0.001, and 0.042, respectively). Non-F-P-NETs are a kind of rare neoplasm, with mostly indolent malignancy. Patients with non-F-P-NETs could benefit from the radical resections. The new WHO criteria, distant metastasis and surgical margin, might be independent predictors for the prognosis of non-F-P-NETs. PMID:25396335

  12. Clinical Outcomes of Percutaneous Endoscopic Surgery for Lumbar Discal Cyst

    PubMed Central

    Ha, Sang Woo; Kim, Seok Won; Lee, SeungMyung; Kim, Yong Hyun; Kim, Hyeun Sung

    2012-01-01

    Objective Discal cyst is rare and causes indistinguishable symptoms from lumbar disc herniation. The clinical manifestations and pathological features of discal cyst have not yet been completely known. Discal cyst has been treated with surgery or with direct intervention such as computed tomography (CT) guided aspiration and steroid injection. The purpose of this study is to evaluate the safety and efficacy of the percutaneous endoscopic surgery for lumbar discal cyst over at least 6 months follow-up. Methods All 8 cases of discal cyst with radiculopathy were treated by percutaneous endoscopic surgery by transforaminal approach. The involved levels include L5-S1 in 1 patient, L3-4 in 2, and L4-5 in 5. The preoperative magnetic resonance imaging and 3-dimensional CT with discogram images in all cases showed a connection between the cyst and the involved intervertebral disc. Over a 6-months period, self-reported measures were assessed using an outcome questionaire that incorporated total back-related medical resource utilization and improvement of leg pain [visual analogue scale (VAS) and Macnab's criteria]. Results All 8 patients underwent endoscopic excision of the cyst with additional partial discectomy. Seven patients obtained immediate relief of symptoms after removal of the cyst by endoscopic approach. There were no recurrent lesions during follow-up period. The mean preoperative VAS for leg pain was 8.25±0.5. At the last examination followed longer than 6 month, the mean VAS for leg pain was 2.25±2.21. According to MacNab' criteria, 4 patients (50%) had excellent results, 3 patients (37.5%) had good results; thus, satisfactory results were achieved in 7 patients (87.5%). However, one case had unsatisfactory result with persistent leg pain and another paresthesia. Conclusion The radicular symptoms were remarkably improved in most patients immediately after percutaneous endoscopic cystectomy by transforaminal approach. PMID:22737300

  13. Aspergillus Osteomyelitis: Epidemiology, Clinical Manifestations, Management, and Outcome

    PubMed Central

    Gamaletsou, Maria N.; Rammaert, Blandine; Bueno, Marimelle A.; Moriyama, Brad; Sipsas, Nikolaos V.; Kontoyiannis, Dimitrios P.; Roilides, Emmanuel; Zeller, Valerie; Prinapori, Roberta; Tajaldeen, Saad Jaber; Brause, Barry; Lortholary, Olivier; Walsh, Thomas J.

    2014-01-01

    Background The epidemiology, pathogenesis, diagnosis, and management of Aspergillus osteomyelitis are not well understood. Methods Protocol-defined cases of Aspergillus osteomyelitis published in the English literature were reviewed for comorbidities, microbiology, mechanisms of infection, clinical manifestations, radiological findings, inflammatory biomarkers, antifungal therapy, and outcome. Results Among 180 evaluable patients, 127 (71%) were males. Possible predisposing medical conditions in 103 (57%) included pharmacological immunosuppression, primary immunodeficiency, and neutropenia. Seventy-three others (41%) had prior open fracture, trauma or surgery. Eighty (44%) followed a hematogenous mechanism, 58 (32%) contiguous infections, and 42 (23%) direct inoculation. Aspergillus osteomyelitis was the first manifestation of aspergillosis in 77%. Pain and tenderness were present in 80%. The most frequently infected sites were vertebrae (46%), cranium (23%), ribs (16%), and long bones (13%). Patients with vertebral Aspergillus osteomyelitis had more previous orthopedic surgery (19% vs 0%; P=0.02), while those with cranial osteomyelitis had more diabetes mellitus (32% vs 8%; P=0.002) and prior head/neck surgery (12% vs 0%; P=0.02). Radiologic findings included osteolysis, soft-tissue extension, and uptake on T2-weighted images. Vertebral body Aspergillus osteomyelitis was complicated by spinal-cord compression in 47% and neurological deficits in 41%. Forty-four patients (24%) received only antifungal therapy, while 121(67%) were managed with surgery and antifungal therapy. Overall mortality was 25%. Median duration of therapy was 90 days (range, 10–772 days). There were fewer relapses in patients managed with surgery plus antifungal therapy in comparison to those managed with antifungal therapy alone (8% vs 30%; P=0.006). Conclusions Aspergillus osteomyelitis is a debilitating infection affecting both immunocompromised and immunocompetent patients. The most

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

    SciTech Connect

    Childs, Stephanie K.; Kozak, Kevin R.; Friedmann, Alison M.; Yeap, Beow Y.; Adams, Judith; MacDonald, Shannon M.; Liebsch, Norbert J.; Tarbell, Nancy J.; Yock, Torunn I.

    2012-02-01

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

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

    PubMed Central

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

    2014-01-01

    Glioblastoma multiforme (GBM) is the most common malignant primary brain tumor with a survival prognosis of 14-16 mo for the highest functioning patients. Despite aggressive, multimodal upfront therapies, the majority of GBMs will recur in approximately six months. Salvage therapy options for recurrent GBM (rGBM) are an area of intense research. This study compares recent survival and quality of life outcomes following Gamma Knife radiosurgery (GKRS) salvage therapy. Following a PubMed search for studies using GKRS as salvage therapy for malignant gliomas, nine articles from 2005 to July 2013 were identified which evaluated rGBM treatment. In this review, we compare Overall survival following diagnosis, Overall survival following salvage treatment, Progression-free survival, Time to recurrence, Local tumor control, and adverse radiation effects. This report discusses results for rGBM patient populations alone, not for mixed populations with other tumor histology grades. All nine studies reported median overall survival rates (from diagnosis, range: 16.7-33.2 mo; from salvage, range: 9-17.9 mo). Three studies identified median progression-free survival (range: 4.6-14.9 mo). Two showed median time to recurrence of GBM. Two discussed local tumor control. Six studies reported adverse radiation effects (range: 0%-46% of patients). The greatest survival advantages were seen in patients who received GKRS salvage along with other treatments, like resection or bevacizumab, suggesting that appropriately tailored multimodal therapy should be considered with each rGBM patient. However, there needs to be a randomized clinical trial to test GKRS for rGBM before the possibility of selection bias can be dismissed. PMID:24829861

  16. Clinical outcomes of a 2-y soy isoflavone supplementation in menopausal women

    Technology Transfer Automated Retrieval System (TEKTRAN)

    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...

  17. Syndrome Co-Occurrence and Treatment Outcomes in Youth Mental Health Clinics

    ERIC Educational Resources Information Center

    Doss, Amanda Jensen; Weisz, John R.

    2006-01-01

    Despite widespread speculation that syndrome co-occurrence undermines treatment outcomes, this hypothesis has not been fully examined within clinical care settings. To address this gap, the authors investigated the relation between syndrome co-occurrence and outcome among 325 clinically referred youths. For every syndrome, higher initial severity…

  18. Clinical Research of Traditional Chinese Medicine Needs to Develop Its Own System of Core Outcome Sets

    PubMed Central

    Zhang, Li; Zhang, Junhua; Chen, Jing; Xing, Dongmei; Wang, Jiaying

    2013-01-01

    Currently, quality issues concerning clinical research of traditional Chinese medicine (TCM) have come into the spotlight. It has been recognized that poorly-devised research methodology largely restricted the development of clinical research in TCM. The choice of appropriate outcome measurements is key to the success of clinical research; however, the current procedure for outcomes selection in clinical research of TCM is problematic due to the underdevelopment of clinical methodology. Under this circumstance, we propose the introduction to the concept of Core Outcome Set (COS) and discuss the feasibility of developing a COS system that caters for clinical studies in TCM, in the hope that the outcome evaluation system could be up to international standards. PMID:24312133

  19. 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. PMID:26674612

  20. Clinical Outcomes of Computed Tomography–Based Volumetric Brachytherapy Planning for Cervical Cancer

    SciTech Connect

    Simpson, Daniel R.; Scanderbeg, Daniel J.; Carmona, Ruben; McMurtrie, Riley M.; Einck, John; Mell, Loren K.; McHale, Michael T.; Saenz, Cheryl C.; Plaxe, Steven C.; Harrison, Terry; Mundt, Arno J.; Yashar, Catheryn M.

    2015-09-01

    Purpose/Objectives: A report of clinical outcomes of a computed tomography (CT)-based image guided brachytherapy (IGBT) technique for treatment of cervical cancer. Methods and Materials: Seventy-six women with International Federation of Gynecology and Obstetrics stage IB to IVA cervical carcinoma diagnosed between 2007 and 2014 were treated with definitive external beam radiation therapy (EBRT) with or without concurrent chemotherapy followed by high-dose-rate (HDR) IGBT. All patients underwent planning CT simulation at each implantation. A high-risk clinical target volume (HRCTV) encompassing any visible tumor and the entire cervix was contoured on the simulation CT. When available, magnetic resonance imaging (MRI) was performed at implantation to assist with tumor delineation. The prescription dose was prescribed to the HRCTV. Results: The median follow-up time was 17 months. Thirteen patients (17%) had an MRI done before brachytherapy, and 16 patients (21%) were treated without MRI guidance. The mean EBRT/IGBT sum 2-Gy equivalent dose (EQD2) delivered to the 90% volume of the HRCTV was 86.3 Gy. The mean maximum EQD2s delivered to 2 cm{sup 3} of the rectum, sigmoid, and bladder were 67.5 Gy, 66.2 Gy, and 75.3 Gy, respectively. The 2-year cumulative incidences of local, locoregional, and distant failure were 5.8% (95% confidence interval [CI]: 1.4%-14.8%), 15.1% (95% CI: 5.4%-29.4%), and 24.3% (95% CI: 12.1%-38.9%), respectively. The 2-year overall and disease-free survival rates were 75% (95% CI, 61%-91%) and 73% (95% CI, 60%-90%), respectively. Twenty-nine patients (38%) experienced grade ≥2 acute toxicity, with 5 cases of acute grade 3 toxicity and no grade ≥4 toxicities. One patient experienced grade 3 gastrointestinal toxicity. No other late grade ≥3 events were observed. Conclusions: This is the largest report to date of CT/MRI-based IGBT for the treatment of cervical cancer. The results are promising, with excellent local control and acceptable

  1. Clinical characteristics and outcome of complicated pneumococcal pneumonia in a pediatric population.

    PubMed

    Wexler, Isaiah D; Knoll, Sharon; Picard, Eli; Villa, Yael; Shoseyov, David; Engelhard, Dan; Kerem, Eitan

    2006-08-01

    The incidence of complicated pneumonia caused by S. pneumoniae is reported to be increasing. This increase may be related to host susceptibility and/or pathogen virulence. The objective of this study was to evaluate clinical and laboratory characteristics associated with complicated pneumococcal pneumonia, and to identify risk factors associated with prolonged fever and hospitalization. The study involved reviewing the records of all children who were hospitalized in four major hospitals in Jerusalem with a confirmed diagnosis of pneumococcal pneumonia during a 12-year period (1986-1997). Demographic, clinical, laboratory, and outcome variables were compared between those with uncomplicated and complicated pneumonia. One hundred and eleven children (median age, 2.2 years) were hospitalized with pneumococcal pneumonia during the study period. Forty-four (39%) of them had complicated pneumonia, characterized by pleural effusion, empyema, pneumothorax, pneumatocele, and/or atelectasis. There was no correlation between the isolation of penicillin-resistant S. pneumonia (16% of cases) and complicated pneumonia. Factors that were significantly associated with complicated pneumonia included weight

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

    PubMed

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

    2016-04-01

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

  3. Calculating Clinically Significant Change: Applications of the Clinical Global Impressions (CGI) Scale to Evaluate Client Outcomes in Private Practice

    ERIC Educational Resources Information Center

    Kelly, Peter James

    2010-01-01

    The Clinical Global Impressions (CGI) scale is a therapist-rated measure of client outcome that has been widely used within the research literature. The current study aimed to develop reliable and clinically significant change indices for the CGI, and to demonstrate its application in private psychological practice. Following the guidelines…

  4. Factors associated with adverse clinical outcomes among obstetric trainees

    PubMed Central

    Aiken PhD, Catherine E.; Aiken, Abigail; Park, Hannah; Brockelsby, Jeremy C.; Prentice, Andrew

    2016-01-01

    Objective To determine whether UK obstetric trainees transitioning from directly to indirectly-supervised practice have a higher likelihood of adverse patient outcomes from operative deliveries compared to other indirectly supervised trainees and to examine whether performing more procedures under direct supervision is associated with fewer adverse outcomes in initial indirect practice. Methods We examined all deliveries (13,861) conducted by obstetricians at a single centre over 5 years (2008-2013). Mixed-effects logistic regression models were used to compare estimated blood loss, maternal trauma, umbilical arterial pH, delayed neonatal respiration, failed instrumental delivery, and critical incidents for trainees in their first indirectly-supervised year with trainees in all other years of indirect practice. Outcomes for trainees in their first indirectly-supervised 3 months were compared to their outcomes for the remainder of the year. Linear regression was used to examine the relationship between number of procedures performed under direct supervision and initial outcomes under indirect supervision. Results Trainees in their first indirectly-supervised year had a higher likelihood of >2 litres estimated blood loss at any delivery (OR 1.32;CI(1.01-1.64) p<0.05) and of failed instrumental delivery (OR 2.33;CI(1.37-3.29) p<0.05) compared with other indirectly-supervised trainees. Other measured outcomes showed no significant differences. Within the first three months of indirect supervision, the likelihood of operative vaginal deliveries with >1litre estimated blood loss (OR 2.54;CI(1.88-3.20) p<0.05) was higher compared to the remainder of the first year. Performing more deliveries under direct supervision prior to beginning indirectly-supervised training was associated with decreased risk of >1litre estimated blood loss (p<0.05). Conclusions Obstetric trainees in their first year of indirectly-supervised practice have a higher likelihood of immediate adverse

  5. Angiographic outcome of endovascular stroke therapy correlated with MR findings, infarct growth, and clinical outcome in the DEFUSE 2 trial

    PubMed Central

    Marks, Michael P.; Lansberg, Maarten G.; Mlynash, Michael; Kemp, Stephanie; McTaggart, Ryan A.; Zaharchuk, Greg; Bammer, Roland; Albers, Gregory W.

    2015-01-01

    Background DEFUSE 2 demonstrated that patients with magnetic resonance imaging mismatch had a favorable clinical response to tissue reperfusion assessed by magnetic resonance imaging. This study reports the endovascular results and correlates angiographic reperfusion with clinical and imaging outcomes. Methods Prospectively enrolled ischemic stroke patients underwent baseline magnetic resonance imaging and started endovascular therapy within 12 h of onset. Patients were classified as either target mismatch or no target mismatch using magnetic resonance imaging. The pre- and postprocedure angiogram was evaluated to determine thrombolysis in cerebral infarction scores. Favorable clinical response was determined at day 30, and good functional outcome was defined as a modified Rankin Scale 0–2 at day 90. Results One-hundred patients had attempted endovascular treatment. At procedure end, 23% were thrombolysis in cerebral infarction 0–1, 31% thrombolysis in cerebral infarction 2A, 28% thrombolysis in cerebral infarction 2B, and 18% thrombolysis in cerebral infarction 3. More favorable thrombolysis in cerebral infarction-reperfusion scores were associated with greater magnetic resonance imaging reperfusion (P < 0·001). thrombolysis in cerebral infarction scores correlated with 30-day favorable clinical response (P = 0·041) and 90-day modified Rankin Scale 0–2 (P = 0·008). These correlations were significant for target mismatch patients at 30 days (P = 0·034) and 90 days (P = 0·003). Infarct growth was strongly associated with poorer thrombolysis in cerebral infarction scores in target mismatch patients (P < 0·001). Patients with thrombolysis in cerebral infarctionnfarction 2A reperfusion had less magnetic resonance imaging reperfusion (P = 0·004) and poorer clinical outcome at 90 days (P = 0·01) compared with thrombolysis in cerebral infarction 2B-3 patients. Conclusion Thrombolysis in cerebral infarction reperfusion following endovascular therapy for

  6. Social Development:: 2 Year Olds

    MedlinePlus

    ... Español Text Size Email Print Share Social Development: 2 Year Olds Page Content Article Body By nature, ... probably are acting the same way. At age two, children view the world almost exclusively through their ...

  7. Language Development: 2 Year Olds

    MedlinePlus

    ... Stages Listen Español Text Size Email Print Share Language Development: 2 Year Olds Page Content Article Body ... Pay attention to how he also is using language to describe ideas and information and to express ...

  8. 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. PMID:18520464

  9. Hypofractionated radiotherapy versus conventionally fractionated radiotherapy for patients with intermediate-risk localised prostate cancer: 2-year patient-reported outcomes of the randomised, non-inferiority, phase 3 CHHiP trial

    PubMed Central

    Wilkins, Anna; Mossop, Helen; Syndikus, Isabel; Khoo, Vincent; Bloomfield, David; Parker, Chris; Logue, John; Scrase, Christopher; Patterson, Helen; Birtle, Alison; Staffurth, John; Malik, Zafar; Panades, Miguel; Eswar, Chinnamani; Graham, John; Russell, Martin; Kirkbride, Peter; O'Sullivan, Joe M; Gao, Annie; Cruickshank, Clare; Griffin, Clare; Dearnaley, David; Hall, Emma

    2015-01-01

    , number ISRCTN97182923. Findings 2100 participants in the CHHiP trial consented to be included in the QoL substudy: 696 assigned to the 74 Gy schedule, 698 assigned to the 60 Gy schedule, and 706 assigned to the 57 Gy schedule. Of these individuals, 1659 (79%) provided data pre-radiotherapy and 1444 (69%) provided data at 24 months after radiotherapy. Median follow-up was 50·0 months (IQR 38·4–64·2) on April 9, 2014, which was the most recent follow-up measurement of all data collected before the QoL data were analysed in September, 2014. Comparison of 74 Gy in 37 fractions, 60 Gy in 20 fractions, and 57 Gy in 19 fractions groups at 2 years showed no overall bowel bother in 269 (66%), 266 (65%), and 282 (65%) men; very small bother in 92 (22%), 91 (22%), and 93 (21%) men; small bother in 26 (6%), 28 (7%), and 38 (9%) men; moderate bother in 19 (5%), 23 (6%), and 21 (5%) men, and severe bother in four (<1%), three (<1%) and three (<1%) men respectively (74 Gy vs 60 Gy, ptrend=0.64, 74 Gy vs 57 Gy, ptrend=0·59). We saw no differences between treatment groups in change of bowel bother score from baseline or pre-radiotherapy to 24 months. Interpretation The incidence of patient-reported bowel symptoms was low and similar between patients in the 74 Gy control group and the hypofractionated groups up to 24 months after radiotherapy. If efficacy outcomes from CHHiP show non-inferiority for hypofractionated treatments, these findings will add to the growing evidence for moderately hypofractionated radiotherapy schedules becoming the standard treatment for localised prostate cancer. Funding Cancer Research UK, Department of Health, and the National Institute for Health Research Cancer Research Network. PMID:26522334

  10. Clinical applicability of nursing outcomes in the evolution of orthopedic patients with Impaired Physical Mobility 1

    PubMed Central

    da Silva, Marcos Barragan; Almeida, Miriam de Abreu; Panato, Bruna Paulsen; Siqueira, Ana Paula de Oliveira; da Silva, Mariana Palma; Reisderfer, Letícia

    2015-01-01

    AIM: to evaluate the clinical applicability of outcomes, according to the Nursing Outcomes Classification (NOC) in the evolution of orthopedic patients with Impaired Physical Mobility METHOD: longitudinal study conducted in 2012 in a university hospital, with 21 patients undergoing Total Hip Arthroplasty, evaluated daily by pairs of trained data collectors. Data were collected using an instrument containing five Nursing Outcomes, 16 clinical indicators and a five point Likert scale, and statistically analyzed. RESULTS: The outcomes Body Positioning: self-initiated, Mobility, Knowledge: prescribed activity, and Fall Prevention Behavior presented significant increases in mean scores when comparing the first and final evaluations (p<0.001) and (p=0.035). CONCLUSION: the use of the NOC outcomes makes it possible to demonstrate the clinical progression of orthopedic patients with Impaired Physical Mobility, as well as its applicability in this context. PMID:25806631

  11. Postoperative Clinical Outcome and Risk Factors for Poor Outcome of Foraminal and Extraforaminal Lumbar Disc Herniation

    PubMed Central

    Bae, Jung Sik; Kang, Kyung Hee; Park, Jeong Hyun; Lim, Jae Hyeon

    2016-01-01

    Objective We evaluated postoperative outcomes in patients who have lumbar foraminal or extraforaminal disc herniation (FELDH) and suggested the risk factors for poor outcomes. Methods A total of 234 patients were selected for this study. Pre- and post-operative Visual Analogue Scale (VAS) and Korean version Oswestry Disability Index (KODI) were evaluated and the changes of both score were calculated. Outcome was defined as excellent, good, fair, and poor based on Mcnab classification. The percentage of superior facetectomy was calculated by using the Maro-view 5.4 Picture Archiving Communication System (PACS). Results Paramedian lumbar discectomy was performed in 180 patients and combined lumbar discectomy was performed in 54 patients. Paramedian lumbar discectomy group showed better outcome compared with combined discectomy group. p value of VAS change was 0.009 and KODI was 0.013. The average percentage of superior facetectomy was 33% (range, 0–79%) and it showed negative correlation with VAS and KODI changes (Pearson coefficient : -0.446 and -0.498, respectively). Excellent or good outcome cases (Group I) were 136 (58.1%) and fair or poor outcome cases (Group II) were 98 (41.9%). The percentage of superior facetectomy was 26.5% at Group I and 42.5% at Group II. There was significant difference in superior facetectomy percentage between Group I and II (p=0.000). Conclusion This study demonstrated that paramedian lumbar discectomy with preservation of facet joints is an effective and good procedure for FELDH. At least 60% of facet should be preserved for excellent or good outcomes. PMID:26962420

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

    PubMed

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

    2013-12-01

    Standard clinical significance classifications are based on movement between the "dysfunctional" and "functional" distributions; however, this dichotomy ignores heterogeneity within the "dysfunctional" population. Based on the methodology described by Tingey, Lambert, Burlingame, and Hansen (1996), the present study sought to present a 3-distribution clinical significance model for the 21-item version of the Depression Anxiety Stress Scales (DASS-21; P. F. Lovibond & Lovibond, 1995) using data from a normative sample (n = 2,914), an outpatient sample (n = 1,000), and an inpatient sample (n = 3,964). DASS-21 scores were collected at pre- and post-treatment for both clinical samples, and patients were classified into 1 of 5 categories based on whether they had made a reliable change and whether they had moved into a different functional range. Evidence supported the validity of the 3-distribution model for the DASS-21, since inpatients who were classified as making a clinically significant change showed lower symptom severity, higher perceived quality of life, and higher clinician-rated functioning than those who did not make a clinically significant change. Importantly, results suggest that the new category of recovering is an intermediate point between recovered and making no clinically significant change. Inpatients and outpatients have different treatment goals and therefore use of the concept of clinical significance needs to acknowledge differences in what constitutes a meaningful change. PMID:23730826

  13. ENDOTHELIAL KERATOPLASTY: CLINICAL OUTCOMES IN THE TWO YEARS FOLLOWING DEEP LAMELLAR ENDOTHELIAL KERATOPLASTY (AN AMERICAN OPHTHALMOLOGICAL SOCIETY THESIS)

    PubMed Central

    Terry, Mark A.

    2007-01-01

    Purpose To evaluate the clinical outcome of small-incision, deep lamellar endothelial keratoplasty (DLEK) for the treatment of endothelial dysfunction. Methods A prospective series of 79 eyes that underwent DLEK by a single surgeon was evaluated. Best spectacle-corrected visual acuity (BSCVA), refractive astigmatism, and central endothelial cell density (ECD) were measured preoperatively and at 6, 12, and 24 months. Results Data was available on 78 eyes (99%) at 6 months, 77 eyes (97%) at 1 year, and 79 eyes (100%) at 2 years. Mean BSCVA preoperatively of 20/71 improved to 20/42 by 6 months and remained stable. Eliminating eyes with known retinal disease, BSCVA of 20/40 or better was present in 60% (40 of 67) of eyes at 6 months, 74% (49 of 66) of eyes at 1 year, and 79% (53 of 68) of eyes at 2 years. Refractive astigmatism preoperatively was .91 ±.78 diopters and was unchanged by surgery over time with results at 6 months of 1.11 ±.76 (P = .052, power = .43), 1 year 1.04 ±.80 (P =.287, power = .06), and 2 years 1.10 ±.70 (P =.467, power = .22). The mean donor ECD preoperatively was 2819 ± 225 (2389 to 3385) cells/mm2, and this decreased by 26% at 6 months (2095 ± 380) (1097 to 2920) (P = .0001; 95% confidence interval [CI] = 643–809), 3% fewer at 1 year (2009 ± 393) (612 to 2723) (P = .054, power = .5), and 17% fewer at 2 years (1536 ± 547) (500 to 2546) (P < .001, 95% CI = 368–585). Complications included one primary graft failure and 4 dislocations into the anterior chamber. Conclusions DLEK provides improved vision and minimal refractive astigmatic change, but progressive ECD decrease over time is of concern. PMID:18427629

  14. Prediction and diagnosis of clinical outcomes affecting restoration margins.

    PubMed

    Dennison, J B; Sarrett, D C

    2012-04-01

    The longevity of dental restorations is largely dependent on the continuity at the interface between the restorative material and adjacent tooth structure (the restoration margin). Clinical decisions on restoration repair or replacement are usually based upon the weakest point along that margin interface. Physical properties of a restorative material, such as polymerisation shrinkage, water sorption, solubility, elastic modulus and shear strength, all have an effect on stress distribution and can significantly affect margin integrity. This review will focus on two aspects of margin deterioration in the oral environment: the in vitro testing of margin seal using emersion techniques to simulate the oral environment and to predict clinical margin failure and the relationship between clinically observable microleakage and secondary caries. The many variables associated with in vitro testing of marginal leakage and the interpretation of the data are presented in detail. The most recent studies of marginal leakage mirror earlier methodology and lack validity and reliability. The lack of standardised testing procedures makes it impossible to compare studies or to predict the clinical performance of adhesive materials. Continual repeated in vitro studies contribute little to the science in this area. Clinical evidence is cited to refute earlier conclusions that clinical microleakage (penetrating margin discoloration) leads to caries development and is an indication for restoration replacement. Margin defects, without visible evidence of soft dentin on the wall or base of the defect, should be monitored, repaired or resealed, in lieu of total restoration replacement. PMID:22066463

  15. Outcome Measures Used in Clinical Trials for Behçet Syndrome: A Systematic Review

    PubMed Central

    Hatemi, Gulen; Merkel, Peter A.; Hamuryudan, Vedat; Boers, Maarten; Direskeneli, Haner; Aydin, Sibel Z.; Yazici, Hasan

    2015-01-01

    Behçet syndrome (BS) is a multisystem vasculitis that is most active during young adulthood, causing serious disability and significant impairment in quality of life. Differences in the disease course, severity, and organ involvement between patients, depending on the age at presentation and sex, makes it impossible to determine a single management strategy. The diversity and variability in the outcome measures used in clinical trials in BS makes it difficult to compare the results or inform physicians about the best management strategy for individual patients. There is a large unmet need to determine or develop validated outcome measures for use in clinical trials in BS that are acceptable to researchers and regulatory agencies. We conducted a systematic review to describe the outcomes and outcome measures that have been used in clinical trials in BS. This review revealed the diversity and variability in the outcomes and outcome measures and the lack of standard definitions for most outcomes and rarity of validated outcome tools for disease assessment in BS. This systematic literature review will identify domains and candidate instruments for use in a Delphi exercise, the next step in the development of a core set of outcome measures that are properly validated and widely accepted by the collaboration of researchers from many different regions of the world and from different specialties, including rheumatology, ophthalmology, dermatology, gastroenterology, and neurology. PMID:24488418

  16. Intensity-Modulated Radiation Therapy in Oropharyngeal Carcinoma: Effect of Tumor Volume on Clinical Outcomes

    SciTech Connect

    Lok, Benjamin H.; Setton, Jeremy; Caria, Nicola; Romanyshyn, Jonathan; Wolden, Suzanne L.; Zelefsky, Michael J.; Park, Jeffery; Rowan, Nicholas; Sherman, Eric J.; Fury, Matthew G.; Ho, Alan; Pfister, David G.; Wong, Richard J.; Shah, Jatin P.; Kraus, Dennis H.; Zhang, Zhigang; Schupak, Karen D.; Gelblum, Daphna Y.; Rao, Shyam D.; Lee, Nancy Y.

    2012-04-01

    Purpose: To analyze the effect of primary gross tumor volume (pGTV) and nodal gross tumor volume (nGTV) on treatment outcomes in patients treated with definitive intensity-modulated radiation therapy (IMRT) for oropharyngeal cancer (OPC). Methods and Materials: Between September 1998 and April 2009, a total of 442 patients with squamous cell carcinoma of the oropharynx were treated with IMRT with curative intent at our center. Thirty patients treated postoperatively and 2 additional patients who started treatment more than 6 months after diagnosis were excluded. A total of 340 patients with restorable treatment plans were included in this present study. The majority of the patients underwent concurrent platinum-based chemotherapy. The pGTV and nGTV were calculated using the original clinical treatment plans. Cox proportional hazards models and log-rank tests were used to evaluate the correlation between tumor volumes and overall survival (OS), and competing risks analysis tools were used to evaluate the correlation between local failure (LF), regional failure (RF), distant metastatic failure (DMF) vs. tumor volumes with death as a competing risk. Results: Median follow-up among surviving patients was 34 months (range, 5-67). The 2-year cumulative incidence of LF, RF and DF in this cohort of patients was 6.1%, 5.2%, and 12.2%, respectively. The 2-year OS rate was 88.6%. Univariate analysis determined pGTV and T-stage correlated with LF (p < 0.0001 and p = 0.004, respectively), whereas nGTV was not associated with RF. On multivariate analysis, pGTV and N-stage were independent risk factors for overall survival (p = 0.0003 and p = 0.0073, respectively) and distant control (p = 0.0008 and p = 0.002, respectively). Conclusions: In this cohort of patients with OPC treated with IMRT, pGTV was found to be associated with overall survival, local failure, and distant metastatic failure.

  17. Long term outcomes of cardiac transplant for immunoglobulin light chain amyloidosis: The Mayo Clinic experience

    PubMed Central

    Grogan, Martha; Gertz, Morie; McCurdy, Arleigh; Roeker, Lindsey; Kyle, Robert; Kushwaha, Sudhir; Daly, Richard; Dearani, Joseph; Rodeheffer, Richard; Frantz, Robert; Lacy, Martha; Hayman, Suzanne; McGregor, Christopher; Edwards, Brooks; Dispenzieri, Angela

    2016-01-01

    AIM: To determine the outcome of orthotopic heart transplantation (OHT) in immunoglobulin light chain (AL) amyloidosis. METHODS: The medical records of patients with AL who underwent orthotopic heart transplantation at the Mayo Clinic in Rochester Minnesota from 1992 to 2011 were reviewed. Patients met at least one of the following at: New York Heart Association class IV heart failure, ventricular thickness > 15 mm, ejection fraction < 40%. Selection guidelines for heart transplant included age < 60 years, absence of multiple myeloma and significant extra-cardiac organ involvement. Baseline characteristics including age, gender, organ involvement, and New York Heart Association functional class were recorded. Laboratory data, waiting time until heart transplant, and type of treatment of the underlying plasma cell disorder were recorded. Survival from the time of OHT was calculated using Kaplan-Meier survival curves. Survival of patients undergoing OHT for AL was compared to that of non-amyloid patients undergoing OHT during the same time period. RESULTS: Twenty-three patients (median age 53 years) with AL received OHT. There were no deaths in the immediate perioperative period. Twenty patients have died post OHT. For the entire cohort, the median overall survival was 3.5 years (95%CI: 1.2, 8.2 years). The 1-year survival post OHT was 77%, the 2-year survival 65%, and the 5-year survival 43%. The 5-year survival for non-amyloid patients undergoing OHT during the same era was 85%. Progressive amyloidosis contributed to death in twelve patients. Of those without evidence of progressive amyloidosis, the cause of death included complications of autologous hematopoietic stem cell transplantation for 3 patients, post-transplant lymphoproliferative disorder for 2 patients; and for the remaining one death was related to each of the following causes: acute rejection; cardiac vasculopathy; metastatic melanoma; myelodysplastic syndrome; and unknown. Eight patients had

  18. Relationship between clozapine dose, serum concentration, and clinical outcome in children and adolescents in clinical practice.

    PubMed

    Wohkittel, Christopher; Gerlach, Manfred; Taurines, Regina; Wewetzer, Christoph; Unterecker, Stefan; Burger, Rainer; Schreck, Diana; Mehler-Wex, Claudia; Romanos, Marcel; Egberts, Karin

    2016-08-01

    Information on dose- and concentration-related clinical effects of clozapine treatment in children and adolescents is scarce. This study aimed to examine the relationship between dose, serum concentration, and clinical outcome as well as the influencing factors thereof in paediatric patients treated with clozapine. Data from a routine Therapeutic Drug Monitoring (TDM) service between 2004 and 2014 were studied in 68 patients, aged 11-18 years. Severity of illness, therapeutic effectiveness and adverse drug reactions (ADRs) were assessed by standardized means. A relationship between the daily dose (mean 319 mg, 4.9 mg/kg) and serum concentration (mean 387 ng/ml) of clozapine was found with the variation in dose explaining 30 % of the variability in clozapine serum concentrations. Also gender contributed to the variability, however, no influence of age or concomitant medications was detected. Furthermore, a significant association was found between clozapine serum concentration and the occurrence of ADRs. Patients without ADRs had a lower mean serum concentration than those with mild (261.4 vs 407.3 ng/ml, P = 0.018) and moderate ADRs (261.4 vs 416.3 ng/ml, P = 0.028). As clozapine was estimated to be effective in lower blood concentrations, guidance on a possibly lower therapeutic range of clozapine serum levels in paediatric patients is provided. With ADRs increasing under higher concentrations, TDM is strongly recommended in paediatric clozapine therapy for individualized dosing. Dose adjustment in females also might be reasonable according to gender-related differences in serum concentrations. However, regarding the limitations of this study results should be validated in larger studies with more standardized designs. PMID:27221285

  19. Clinical Outcomes Following the Latarjet Procedure in Contact and Collision Athletes

    PubMed Central

    Privitera, David M.; Siegel, Elana J.; Higgins, Laurence D.

    2014-01-01

    Objectives: Although there are several reports of clinical outcomes after the Latarjet procedure for recurrent anterior glenohumeral instability, the literature is sparse for these Latarjet outcomes in the strictly contact or collision-type sport athletes who have significant glenoid deficiency and/or failed previous stabilization surgery. The purpose of this study was to evaluate the clinical and functional results of these contact or collision athletes who underwent a Latarjet for symptomatic instability with glenoid bone loss or failed stabilization surgery, using modern instability outcome measures. Study Design: Case series, Level of evidence, 4. Methods: Sixty-one consecutive contact and/or collision athletes (64 shoulders) treated with an open Latarjet procedure for recurrent anterior glenohumeral instability with significant glenoid bony deficiency and/or failed prior stabilization were retrospectively identified from two surgeons’ practices. Thirty-nine patients and 42 shoulders (66%) were evaluated at a mean follow-up of 46 months (range: 24-95), whose an average age of surgery of 25.9 years (range: 16-47). Primary outcome measures were the Western Ontario Shoulder Instability Index (WOSI), American Shoulder and Elbow Society Questionnaire (ASES), Visual Analogue Scale, and return to sporting activity. IRB approval was granted for this study. Results: Thirty-seven of forty-two shoulders (88%) were perceived as stable to these athletes. Two patients experienced subluxation events at 18 and 24 months after their Latarjet procedures. These 2 patients underwent further surgery including an arthroscopic debridement with biceps tenodesis and the other a revision stabilization Eden-Hybinette procedure, performed at 22 and 29 months after their Latarjets, respectively. One additional patient underwent surgery for hardware removal with arthroscopic debridement, with no reports of concomitant instability. Average WOSI and ASES scores for 42 shoulders were 76

  20. Type I Diabetes: Translating Mechanistic Observations into Effective Clinical Outcomes

    PubMed Central

    Herold, Kevan C.; Vignali, Dario A.A.; Cooke, Anne; Bluestone, Jeffrey A.

    2014-01-01

    Summary Type 1 diabetes remains an important health problem, particularly in Western countries where the incidence has been increasing in younger children1. In 1986, Eisenbarth described Type 1 diabetes as a chronic autoimmune disease. Work over the past 3 ½ decades has identified many of the genetic, immunologic, and environmental factors that are involved in the disease and have led to hypotheses concerning its pathogenesis. Based on these findings, clinical trials have been conducted to test these hypotheses but have had mixed results. In this review, we discuss the findings that have led to current concepts of the disease mechanisms, how this understanding has prompted clinical studies, and the results of these studies. The findings from preclinical and clinical studies support the original proposed model for how type 1 diabetes develops, but have also suggested that this disease is more complex than originally thought and will require broader treatment approaches. PMID:23524461

  1. Clinical Manifestations, Laboratory Findings, and Treatment Outcomes of SARS Patients

    PubMed Central

    Wang, Jann-Tay; Sheng, Wang-Huei; Fang, Chi-Tai; Chen, Yee-Chun; Wang, Jiun-Ling; Yu, Chong-Jen; Yang, Pan-Chyr

    2004-01-01

    Clinical and laboratory data on severe acute respiratory syndrome (SARS), particularly on the temporal progression of abnormal laboratory findings, are limited. We conducted a prospective study on the clinical, radiologic, and hematologic findings of SARS patients with pneumonia, who were admitted to National Taiwan University Hospital from March 8 to June 15, 2003. Fever was the most frequent initial symptom, followed by cough, myalgia, dyspnea, and diarrhea. Twenty-four patients had various underlying diseases. Most patients had elevated C-reactive protein (CRP) levels and lymphopenia. Other common abnormal laboratory findings included leukopenia, thrombocytopenia, and elevated levels of aminotransferase, lactate dehydrogenase, and creatine kinase. These clinical and laboratory findings were exacerbated in most patients during the second week of disease. The overall case-fatality rate was 19.7%. By multivariate analysis, underlying disease and initial CRP level were predictive of death. PMID:15200814

  2. Association of β-blocker therapy with long-term clinical outcomes in patients with coronary chronic total occlusion.

    PubMed

    Hwang, Jin Kyung; Yang, Jeong Hoon; Hwang, Ji-Won; Jang, Woo Jin; Song, Young Bin; Hahn, Joo-Yong; Choi, Jin-Ho; Lee, Sang Hoon; Gwon, Hyeon-Cheol; Choi, Seung-Hyuk

    2016-07-01

    There are limited data regarding the efficacy of β-blockers for secondary prevention in patients with coronary chronic total occlusion (CTO). Therefore, we investigated the association of β-blocker therapy with long-term clinical outcomes in CTO patients. From March 2003 to February 2012, a total of 2024 CTO patients treated with either medical therapy alone or revascularization were enrolled in the study. We assessed 1596 patients with stable ischemic heart disease and divided them into the β-blocker group (n = 932) and the no-β-blocker group (n = 664). The primary outcome was all-cause death. The median follow-up duration was 3.9 (interquartile range: 2.0-6.2) years. All-cause death occurred in 11.6% patients in the β-blocker group and 13.6% patients in the no-β-blocker group (hazard ratio [HR]: 0.81, 95% confidence interval [CI]: 0.61-1.08; P = 0.15). In the propensity score-matched population (570 pairs), all-cause death occurred in 12.3% patients in the β-blocker group and 12.8% patients in the no-β-blocker group (HR: 0.93, 95% CI: 0.67-1.29; P = 0.66). In subgroup analysis, β-blocker therapy was associated with better outcome, in terms of all-cause death, in patients with CTO of the left anterior descending coronary artery and Synergy Between PCI with Taxus and Cardiac Surgery (SYNTAX) score ≥23 (P for interaction = 0.01 and 0.02, respectively). In conclusion, β-blocker therapy was not associated with favorable long-term clinical outcomes in stable CTO patients, regardless of treatment strategy. However, β-blocker therapy might be beneficial in a highly selective group of CTO patients with a high ischemic burden. PMID:27472704

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

    PubMed

    Wong, Brian M; Holmboe, Eric S

    2016-04-01

    The current health care delivery model continues to fall short in achieving the desired patient safety and quality-of-care outcomes for patients. And, until recently, an explicit acknowledgment of the role and influence of the clinical learning environment on professional development had been missing from physician-based competency frameworks. In this Perspective, the authors explore the implications of the insufficient integration of education about patient safety and quality improvement by academic faculty into the clinical learning environment in many graduate medical education (GME) programs, and the important role that academic faculty need to play to better align the educational and clinical contexts to improve both learner and patient outcomes. The authors propose a framework that closely aligns the educational and clinical contexts, such that both educational and clinical outcomes are centered around the patient. This will require a reorganization of academic faculty perspective and educational design of GME training programs that recognizes that (1) the dynamic interplay between the faculty, learner, training program, and clinical microsystem ultimately influences the quality of physician that emerges from the training program and environment, and (2) patient outcomes relate to the quality of education and the success of clinical microsystems. To enable this evolution, there is a need to revisit the core competencies expected of academic faculty, implement innovative faculty development strategies, examine closely faculty's current clinical super vision practices, and establish a training environment that supports bridging from clinician to educator, training program to clinical microsystem, and educational outcomes to clinical outcomes that benefit patients. PMID:26703412

  4. Treatment of Chronic Stuttering: Outcomes from a Student Training Clinic

    ERIC Educational Resources Information Center

    Block, Susan; Onslow, Mark; Packman, Ann; Gray, Belinda; Dacakis, Georgia

    2005-01-01

    Background: It has been suggested that one way to increase speech pathologists' confidence in working with people who stutter is to provide them with relevant and stimulating clinical experiences during their professional preparation. This paper describes a treatment programme for adults who stutter that is conducted by speech pathology students,…

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

    ERIC Educational Resources Information Center

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

    2009-01-01

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

  6. Arterial Stiffening and Clinical Outcomes in Dialysis Patients.

    PubMed

    Kato, Akihiko

    2015-09-01

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

  7. Very poor outcome schizophrenia: Clinical and neuroimaging aspects

    PubMed Central

    Mitelman, Serge A.; Buchsbaum, Monte S.

    2009-01-01

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

  8. Completeness of Reporting of Patient-Relevant Clinical Trial Outcomes: Comparison of Unpublished Clinical Study Reports with Publicly Available Data

    PubMed Central

    Wieseler, Beate; Wolfram, Natalia; McGauran, Natalie; Kerekes, Michaela F.; Vervölgyi, Volker; Kohlepp, Petra; Kamphuis, Marloes; Grouven, Ulrich

    2013-01-01

    Background Access to unpublished clinical study reports (CSRs) is currently being discussed as a means to allow unbiased evaluation of clinical research. The Institute for Quality and Efficiency in Health Care (IQWiG) routinely requests CSRs from manufacturers for its drug assessments. Our objective was to determine the information gain from CSRs compared to publicly available sources (journal publications and registry reports) for patient-relevant outcomes included in IQWiG health technology assessments (HTAs) of drugs. Methods and Findings We used a sample of 101 trials with full CSRs received for 16 HTAs of drugs completed by IQWiG between 15 January 2006 and 14 February 2011, and analyzed the CSRs and the publicly available sources of these trials. For each document type we assessed the completeness of information on all patient-relevant outcomes included in the HTAs (benefit outcomes, e.g., mortality, symptoms, and health-related quality of life; harm outcomes, e.g., adverse events). We dichotomized the outcomes as “completely reported” or “incompletely reported.” For each document type, we calculated the proportion of outcomes with complete information per outcome category and overall. We analyzed 101 trials with CSRs; 86 had at least one publicly available source, 65 at least one journal publication, and 50 a registry report. The trials included 1,080 patient-relevant outcomes. The CSRs provided complete information on a considerably higher proportion of outcomes (86%) than the combined publicly available sources (39%). With the exception of health-related quality of life (57%), CSRs provided complete information on 78% to 100% of the various benefit outcomes (combined publicly available sources: 20% to 53%). CSRs also provided considerably more information on harms. The differences in completeness of information for patient-relevant outcomes between CSRs and journal publications or registry reports (or a combination of both) were statistically

  9. Clinical outcome assessment in malignant glioma trials: measuring signs, symptoms, and functional limitations.

    PubMed

    Blakeley, Jaishri O; Coons, Stephen Joel; Corboy, John R; Leidy, Nancy Kline; Mendoza, Tito R; Wefel, Jeffrey S

    2016-03-01

    The shared goal of all parties developing therapeutics against malignant gliomas is to positively impact the lives of people affected by these cancers. Clinical outcome assessment (COA) tools, including measures of patient-reported outcome, performance outcome, clinician-reported outcome, and observer-reported outcome, allow patient-focused assessments to complement traditional efficacy measures such as overall survival and radiographic endpoints. This review examines the properties of various COA measures used in malignant glioma clinical trials to date and cross references their content to the priority signs, symptoms, and functional limitations defined through a community survey conducted by the National Brain Tumor Society. The overarching goal of this initiative is to identify COA measures that are feasible and have appropriate psychometric properties for use in this patient population as well as highlight where further development is needed. PMID:26989128

  10. Outcome measures for clinical trials assessing treatment of cystic fibrosis lung disease

    PubMed Central

    VanDevanter, Donald R; Konstan, Michael W

    2015-01-01

    Cystic fibrosis (CF) is a complex genetic disease characterized by death from loss of lung function. Therapies target pathophysiologic changes associated with pulmonary disease progression. Although therapeutic mechanisms differ, efficacy demonstration is limited to a few accepted outcome measures, each with shortcomings that are becoming more pronounced as CF population health improves. Pulmonary function improvement (as forced expiratory volume in 1 s [FEV1]) and reduction of pulmonary exacerbation risk are commonly used outcomes. Changes in FEV1 decline rate, quality of life, linear growth and/or weight gain are less utilized outcomes. Validated outcomes tend to work best in subjects with more aggressive or advanced lung disease and less so in healthier subjects. Assays of effects on primary therapeutic targets have yet to be validated as surrogate measures of clinical efficacy. As CF population health improves, it will become increasingly difficult to employ current clinical outcome measures to demonstrate efficacy. PMID:26146539

  11. Systematic Review of Outcome Measures Reported in Clinical Canine Osteoarthritis Research

    PubMed Central

    Asher, Lucy; Dean, Rachel S.

    2016-01-01

    Objective To record and categorize the outcome measures used in dogs with naturally occurring osteoarthritis (OA) by systematically reviewing the peer reviewed publications on OA in dogs. Study Design Systematic literature review. Study Population Peer reviewed literature on canine OA. Methods A computer‐based bibliographic search was performed on PubMed and CAB Abstracts in August 2013 to find peer reviewed publications relevant to canine OA. Inclusion and exclusion criteria were applied. The outcome measures reported within each publication were recorded and categorized for comparison. Adequately described outcome measures were assessed for uniqueness and evidence of prior validation. Results Of 3,697 publications identified and screened, 117 were deemed eligible for inclusion. Within eligible publications, outcome measures were used 618 times (median of 4 outcome measures per publication). Outcomes measured were divided into 5 groups containing 65 categories. The most frequently assessed outcomes were lameness assessment with no stated gait/mixed gaits (66 outcomes), radiography (58), and lameness single gait/lateral motion (55). Of 618 outcome measures reported, 491 were assessed for uniqueness and 348 (71%) were unique to a single publication. Ten outcome measures were reported to have been validated. Conclusion Many outcome measures have been used to assess canine OA. There is no consensus on which are the most useful outcomes or by which method they should be assessed. There is a pressing need for agreement on outcomes reporting in canine OA and for validation of outcome measures used for these assessments. Until consensus is reached, we recommend at least one validated outcome measure be used in every clinical study. PMID:27120270

  12. Connecting Stuttering Management and Measurement: I. Core Speech Measures of Clinical Process and Outcome

    ERIC Educational Resources Information Center

    Shenker, Rosalee C.

    2006-01-01

    Background: There will always be a place for stuttering treatments designed to eliminate or reduce stuttered speech. When those treatments are required, direct speech measures of treatment process and outcome are needed in clinical practice. Aims: Based on the contents of published clinical trials of such treatments, three "core" measures of…

  13. Effect of Malnutrition at Diagnosis on Clinical Outcomes of Children With Acute Lymphoblastic Leukemia.

    PubMed

    Yazbeck, Nadine; Samia, Loma; Saab, Raya; Abboud, Miguel R; Solh, Hassan; Muwakkit, Samar

    2016-03-01

    Acute lymphoblastic leukemia (ALL) is the most common malignancy among children. Although studies have shown that malnutrition can negatively affect treatment outcome, results are controversial. This retrospective study aims at determining the prevalence of malnutrition and its association with treatment outcome among children with ALL treated at the Children's Cancer Institute in Lebanon. A total of 103 patients diagnosed with ALL between April 2002 and May 2010 were enrolled. Anthropometric data were collected from medical records upon diagnosis, at 3 and 6 months, and at the end of treatment. Body mass index was calculated for children 2 years of age and older, whereas weight-for-height ratio was used for patients below 2 years. Patients were considered underweight, stunted, or wasted if their Z-scores were <-2 SD. The prevalence of malnourished children was 25.2% at diagnosis and remained almost the same at the end of treatment. The odds of having a poor outcome (death and relapse) was higher among malnourished children and more so among stunted children with an odds ratios=2.15; 95% confidence interval, 0.5-8.3 and odds ratio=2.63; 95% confidence interval, 0.6-11.5, respectively. Although there was a trend showing worse outcomes in malnourished children with ALL at diagnosis when compared with well-nourished children larger studies using additional tools like arm anthropometry need to be conducted to prove the association. PMID:26479995

  14. Pediatric kidney disease: tracking onset and improving clinical outcomes.

    PubMed

    Bates, Carlton M; Charlton, Jennifer R; Ferris, Maria E; Hildebrandt, Friedhelm; Hoshizaki, Deborah K; Warady, Bradley A; Moxey-Mims, Marva M

    2014-06-01

    Recent studies confirm that much of adult kidney disease may have its origins in childhood, often as a result of abnormal or suboptimal fetal kidney development. Understanding of the etiology and pathogenesis of CKD in children is rapidly evolving because of robust longitudinal clinical data, identification of monogenic mutations related to common causes of CKD, and improved knowledge of factors that influence the onset and progression of CKD. The Kidney Research National Dialogue, supported by the National Institute of Diabetes and Digestive and Kidney Diseases, asked the research and clinical communities to formulate and prioritize research objectives that would improve understanding of kidney function and diseases. This commentary outlines high-priority research objectives to assess factors associated with the predisposition to develop renal disease in children, and address the unique challenges in treating this population. PMID:24651076

  15. [Assessment of individual clinical outcomes: regarding an electroconvulsive therapy case].

    PubMed

    Iraurgi, Ioseba; Gorbeña, Susana; Martínez-Cubillos, Miren-Itxaso; Escribano, Margarita; Gómez-de-Maintenant, Pablo

    2015-01-01

    Evaluation of therapeutic results and of the efficacy and effectiveness of treatments is an area of interest both for clinicians and researchers. In general, randomized controlled trial designs have been used as the methodology of choice in which intergroup comparisons are made having a minimum of participants in each arm of treatment. However, these procedures are seldom used in daily clinical practice. Despite this fact, the evaluation of treatment results for a specific patient is important for the clinician in order to address if therapeutic goals have been accomplished both in terms of statistical significance and clinical meaningfulness. The methodology based on the reliable change index (Jacobson y Truax)1 provides an estimate of these two criteria. The goal of this article is to propose a procedure to apply the methodology with a single case study of a woman diagnosed with major depression and treated with electroconvulsive therapy. PMID:25282427

  16. Graphical representation of clinical outcomes for patients with myelodysplastic syndromes.

    PubMed

    Steensma, David P

    2016-01-01

    The causes of death in patients with myelodysplastic syndromes (MDS) are diverse: infections, hemorrhage, complications of chronic anemia and repeated blood transfusions, and complications of progression to acute myeloid leukemia. Since most patients with MDS are diagnosed late in life, some individuals with MDS will succumb to an unrelated condition, such as one of the disorders that are common in geriatric populations. Currently, only a small proportion of patients with MDS - less than 5% - undergo allogeneic stem cell transplantation, a procedure that offers the only possibility of cure. This brief review summarizes outcomes for patients diagnosed with MDS using a pictographical format that illustrates both the challenges patients face and the pressing need for development of novel therapies, as well as highlighting the potential for increased use of allogeneic stem cell transplant. This informational graphic may be useful for teaching or in counseling certain patients. PMID:26098015

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

    PubMed

    Kurbad, A

    2015-01-01

    In esthetic rehabilitation, it is a challenge to meet the needs of patients with growing expectations. Creating predictable results is the key to success. This can be accomplished by performing a comprehensive esthetic diagnosis, elaborating treatment proposals that satisfy today's esthetic standards, and using modern computer-assisted methods. The diagnostic wax-up and mock-up are effective tools that allow patients to visualize treatment proposals without invasive procedures. Once the patient has approved the proposals, they provide the basis for the fabrication of the final restoration. The use of modern ceramic materials makes it possible to achieve a good esthetic outcome, even in restorations with extremely thin layer thicknesses. Esthetic cementation is the final step of restorative treatment. PMID:25911830

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

    PubMed

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

    2015-07-01

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

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

    PubMed Central

    Jorge, Stéphane; Becquemin, Marie-Hélène; Delerme, Samuel; Bennaceur, Mohamed; Isnard, Richard; Achkar, Rony; Riou, Bruno; Boddaert, Jacques; Ray, Patrick

    2007-01-01

    Background Cardiac asthma is common, but has been poorly investigated. The objective was to compare the characteristics and outcome of cardiac asthma with that of classical congestive heart failure (CHF) in elderly patients. Methods Prospective study in an 1,800-bed teaching hospital. Results Two hundred and twelve consecutive patients aged ≥ 65 years presenting with dyspnea due to CHF (mean age of 82 ± 8 years) were included. Findings of cardiac echocardiography and natriuretic peptides levels were used to confirm CHF. Cardiac asthma patients were defined as a patient with CHF and wheezing reported by attending physician upon admission to the emergency department. The CHF group (n = 137) and the cardiac asthma group (n = 75), differed for tobacco use (34% vs. 59%, p < 0.05), history of chronic obstructive pulmonary disease (16% vs. 47%, p < 0.05), peripheral arterial disease (10% vs. 24%, p < 0.05). Patients with cardiac asthma had a significantly lower pH (7.38 ± 0.08 vs. 7.43 ± 0.06, p < 0.05), and a higher PaCO2 (47 ± 15 vs. 41 ± 11 mmHg, p < 0.05) at admission. In the cardiac asthma group, patients had greater distal airway obstruction: forced expiratory volume in 1 second of 1.09 vs. 1.33 Liter (p < 0.05), and a forced expiratory flow at 25% to 75% of vital capacity of 0.76 vs. 0.99 Liter (p < 0.05). The in-hospital (23% vs. 19%) and one year mortality (48% vs. 43%) rates were similar. Conclusion Patients with cardiac asthma represented one third of CHF in elderly patients. They were more hypercapnic and experienced more distal airway obstruction. However, outcomes were similar. PMID:17498318

  20. Recurrent petroclival meningiomas: clinical characteristics, management, and outcomes.

    PubMed

    Li, Da; Hao, Shu-Yu; Wang, Liang; Tang, Jie; Xiao, Xin-Ru; Jia, Gui-Jun; Wu, Zhen; Zhang, Li-Wei; Zhang, Jun-Ting

    2015-01-01

    This study seeks to elucidate the prognostic predictors and outcomes of recurrent/progressive petroclival meningiomas (PCMs). We reviewed our cohort of 39 recurrent/progressive PCMs (27 females, 69.2%) and analyzed the results from the literature. Twenty-three patients underwent reoperations, 2 received radiotherapy alone, and 14 declined any treatment. During a follow-up of 70.4 months, 7 patients experienced a 2nd recurrence/progression (R/P) and 18 patients died. In the 23 patients, gross total resection (GTR), subtotal resection (STR), and partial resection (PR) were achieved in 8, 8, and 7 patients, respectively. The percentage of the 2nd R/P-free survival of GTR, STR, and PR was 88%, 67%, and 40%, respectively. The overall survival following the 1st R/P of GTR, STR, and PR was 88%, 63%, and 33%, respectively. Patients rejecting treatment suffered from significantly poor overall survival (7%; p = 0.001) and short survival duration (42.0 months; p = 0.016) compared with that of the patients receiving treatment (67% and 86.9 months). The GTR was the only independent favorable predictor. In the 21 included studies with 98 recurrent/progressive PCM patients, 17 patients presented with a 2nd R/P and 10 died of a 2nd R/P; patients undergoing observation had a significantly poor tumor regrowth control rate compared with patients undergoing surgery (p = 0.004) or radiotherapy alone (p < 0.001). Proactive treatment should be performed for patients with recurrent/progressive PCMs. Observation can lead to relentless outcome. GTR as a preferential therapeutic strategy should be pursued as far as possible on the condition of minimal functional impairment. PMID:25319087

  1. Emotional Development: 2 Year Olds

    MedlinePlus

    ... Español Text Size Email Print Share Emotional Development: 2 Year Olds Page Content Article Body It’s so ... to follow the ups and downs of a two-year-old. One moment he’s beaming and friendly; ...

  2. Impact of Fluoroquinolone Exposure Prior to Tuberculosis Diagnosis on Clinical Outcomes in Immunocompromised Patients.

    PubMed

    Lee, Ju Young; Lee, Hyun Jung; Kim, Yong Kyun; Yu, Shinae; Jung, Jiwon; Chong, Yong Pil; Lee, Sang-Oh; Choi, Sang-Ho; Shim, Tae Sun; Kim, Yang Soo; Woo, Jun Hee; Kim, Sung-Han

    2016-07-01

    There have been concerns about an association of fluoroquinolone (FQ) use prior to tuberculosis (TB) diagnosis with adverse outcomes. However, FQ use might prevent clinical deterioration in missed TB patients, especially in those who are immunocompromised, until they receive definitive anti-TB treatment. All adult immunocompromised patients with smear-negative and culture-positive TB at a tertiary care hospital in Korea over a 2-year period were included in this study. Long-term FQ (≥7 days) use was defined as exposure to FQ for at least 7 days prior to TB diagnosis. A total of 194 patients were identified: 33 (17%) in the long-term FQ group and 161 (83%) in the comparator, including a short-term FQ group (n = 23), non-FQ group (n = 78), and a group receiving no antibiotics (n = 60). Patients in the long-term FQ group presented with atypical chest radiologic pattern more frequently than those in the comparator (77% [24/31] versus 46% [63/138]; P = 0.001). The median time from mycobacterial test to positive mycobacterial culture appeared to be longer in the long-term FQ group (8.1 weeks versus 7.7 weeks; P = 0.09), although the difference was not statistically significant. Patients in the long-term FQ group were less likely to receive empirical anti-TB treatment (55% versus 74%; P = 0.03). The median time from mycobacterial test to anti-TB therapy was longer in the long-term FQ group (4.6 weeks versus 2.2 weeks; P < 0.001), but there was no significant difference in FQ resistance (0% versus 3%; P > 0.99) or in the 30-day (6% versus 6%; P > 0.99) or 90-day (12% versus 12%; P > 0.99) mortality rate between the two groups. FQ exposure (≥7 days) prior to TB diagnosis in immunocompromised patients appears not to be associated with adverse outcomes. PMID:27090178

  3. Clinical Outcomes and Correlates of TP53 Mutations and Cancer

    PubMed Central

    Robles, Ana I.; Harris, Curtis C.

    2010-01-01

    The initial observation that p53 accumulation might serve as a surrogate biomarker for TP53 mutation has been the cornerstone for vast translational efforts aimed at validating its clinical use for the diagnosis, prognosis, and treatment of cancer. Early on, it was realized that accurate evaluation of p53 status and function could not be achieved through protein-expression analysis only. As our understanding of the p53 pathway has evolved and more sophisticated methods for assessment of p53 functional integrity have become available, the clinical and molecular epidemiological implications of p53 abnormalities in cancers are being revealed. They include diagnostic testing for germline p53 mutations, and the assessment of selected p53 mutations as biomarkers of carcinogen exposure and cancer risk and prognosis. Here, we describe the strengths and limitations of the most frequently used techniques for determination of p53 status in tumors, as well as the most remarkable latest findings relating to its clinical and epidemiological value. PMID:20300207

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

    PubMed

    Gatchel, R J; Maddrey, A M

    1998-09-01

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

  5. Outcome assessment in cellulitis clinical trials: is telephone follow up sufficient?

    PubMed

    Nambudiri, V E; Dwyer, R C; Camargo, C A; Kupper, T S; Pallin, D J

    2015-07-01

    The US Food and Drug Administration has scrutinized clinical trial methodology in cellulitis, partly because the definition and timing of cure are debatable. We analysed the validity of telephone self-report as a proxy for in-person follow up in a cellulitis treatment trial comparing cephalexin alone with cephalexin-plus-trimethoprim/sulfamethoxazole. Our results demonstrate poor agreement between these two methods of outcome determination and have implications for future cellulitis clinical trial design and clinical management. PMID:25882364

  6. Caspofungin: Pharmacodynamics, pharmacokinetics, clinical uses and treatment outcomes.

    PubMed

    Song, Jessica C; Stevens, David A

    2016-09-01

    Over the past decade, echinocandins have emerged as first-line antifungal agents for many Candida infections. The echinocandins have a unique mechanism of action, inhibiting the synthesis of β-1,3-d-glucan polymers, key components of the cell wall in pathogenic fungi. Caspofungin was the first echinocandin antifungal agent to become licensed for use. The objectives of this review are to summarize the existing published data on caspofungin, under the subject headings of chemistry and mechanism of action, spectrum of activity, pharmacodynamics, pharmacokinetics, clinical studies, safety, drug interactions, dosing, and an overview of the drug's current place in therapy. PMID:26369708

  7. Ultrasonic vs. hand instrumentation in periodontal therapy: clinical outcomes.

    PubMed

    Krishna, Ranjitha; De Stefano, Jamie A

    2016-06-01

    Periodontal disease is the most common oral disease in adults. Traditional nonsurgical periodontal therapy involves subgingival removal of hard and soft deposits on the root surface, along with maintenance of good oral hygiene. Nonsurgical periodontal therapy can either be definitive or part of the initial phase before surgical therapy. Mechanical therapy, either with hand or ultrasonic instrumentation, is the keystone of nonsurgical periodontal therapy. This requires considerable amounts of time and a high level of operator skill. The use of appropriate instruments greatly increases clinical efficiency. This article discusses the use of ultrasonic and hand instrumentation, along with recent advances, and the benefits of adjunctive therapy during nonsurgical periodontal therapy. PMID:27045433

  8. 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

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

    PubMed

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

    2009-01-01

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

  10. Is diabetes management in primary care improving clinical outcomes? A study in Qatar.

    PubMed

    Mochtar, I; Al-Monjed, M F

    2015-04-01

    There has been little research into the effectiveness of primary-care diabetes clinics in the Middle East. This study in Qatar compared patient outcomes at a primary-care facility with a dedicated diabetes clinic and one without. Using a cross-sectional method, data on demographics, diabetes status and 6 clinical outcomes of diabetes care were collected from the records of patients who visited the clinics during 2012. Diabetes management in both facilities improved clinical outcomes over the 1-year observation period. The mean total cholesterol of patients attending the special clinic (n = 102) decreased significantly from 4.66 to 4.27 mmol/dL and LDL cholesterol from 3.42 to 3.22 mmol/dL. The LDL cholesterol of patients receiving standard care (n = 108) reduced significantly from 3.41 to 3.22 mmol/dL and HDL cholesterol increased from 0.83 to 0.87 mmol/dL. Inter-provider comparisons indicated that the outcomes in the facility with a diabetes clinic were not superior to those in the facility with standard care. PMID:26077518

  11. Bayesian Nonparametric Estimation of Targeted Agent Effects on Biomarker Change to Predict Clinical Outcome

    PubMed Central

    Graziani, Rebecca; Guindani, Michele; Thall, Peter F.

    2015-01-01

    Summary The effect of a targeted agent on a cancer patient's clinical outcome putatively is mediated through the agent's effect on one or more early biological events. This is motivated by pre-clinical experiments with cells or animals that identify such events, represented by binary or quantitative biomarkers. When evaluating targeted agents in humans, central questions are whether the distribution of a targeted biomarker changes following treatment, the nature and magnitude of this change, and whether it is associated with clinical outcome. Major difficulties in estimating these effects are that a biomarker's distribution may be complex, vary substantially between patients, and have complicated relationships with clinical outcomes. We present a probabilistically coherent framework for modeling and estimation in this setting, including a hierarchical Bayesian nonparametric mixture model for biomarkers that we use to define a functional profile of pre-versus-post treatment biomarker distribution change. The functional is similar to the receiver operating characteristic used in diagnostic testing. The hierarchical model yields clusters of individual patient biomarker profile functionals, and we use the profile as a covariate in a regression model for clinical outcome. The methodology is illustrated by analysis of a dataset from a clinical trial in prostate cancer using imatinib to target platelet-derived growth factor, with the clinical aim to improve progression-free survival time. PMID:25319212

  12. Bayesian nonparametric estimation of targeted agent effects on biomarker change to predict clinical outcome.

    PubMed

    Graziani, Rebecca; Guindani, Michele; Thall, Peter F

    2015-03-01

    The effect of a targeted agent on a cancer patient's clinical outcome putatively is mediated through the agent's effect on one or more early biological events. This is motivated by pre-clinical experiments with cells or animals that identify such events, represented by binary or quantitative biomarkers. When evaluating targeted agents in humans, central questions are whether the distribution of a targeted biomarker changes following treatment, the nature and magnitude of this change, and whether it is associated with clinical outcome. Major difficulties in estimating these effects are that a biomarker's distribution may be complex, vary substantially between patients, and have complicated relationships with clinical outcomes. We present a probabilistically coherent framework for modeling and estimation in this setting, including a hierarchical Bayesian nonparametric mixture model for biomarkers that we use to define a functional profile of pre-versus-post-treatment biomarker distribution change. The functional is similar to the receiver operating characteristic used in diagnostic testing. The hierarchical model yields clusters of individual patient biomarker profile functionals, and we use the profile as a covariate in a regression model for clinical outcome. The methodology is illustrated by analysis of a dataset from a clinical trial in prostate cancer using imatinib to target platelet-derived growth factor, with the clinical aim to improve progression-free survival time. PMID:25319212

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

    PubMed Central

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

    2013-01-01

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

  14. Clinical outcome of surgical treatment for periorbital basal cell carcinoma.

    PubMed

    Kakudo, Natsuko; Ogawa, Yutaka; Suzuki, Kenji; Kushida, Satoshi; Kusumoto, Kenji

    2009-11-01

    Basal cell carcinoma (BCC) has a predilection for the periorbital region, which is a special, prominent, cosmetic, functional area to protect the eyeball. For squamous cell carcinoma and melanoma, extensive resection with reconstruction is performed. In contrast, for BCC, resection is often confined to a small to medium-sized area, necessitating higher-quality reconstructive surgery. We analyze the surgical outcomes of treatment for periorbital BCC, and evaluate reconstruction method after resection. Forty-nine patients with periorbital BCC had surgery in our hospital over 20 years. Age, gender of the patients, and size, localization, and histology of the tumor, and surgical procedures, and their early and late complications were analyzed retrospectively. BCC was most frequently occurred in the lower lid (55%), followed by inner canthus (19%), upper lid (17%), and outer canthus (9%). The histologic classifications were solid (80%), morphea (7%), mix (7%), superficial (2%), keratotic (2%), and adenoid (2%). Recurrence of the tumor was observed in 2 advanced cases in patients treated with resection of the tumor including surrounding tissue 5 mm from the margin. A rotation advancement cheek flap procedure was most frequently applied. Horizontal shift of the skin was most effective to prevent postoperative lagophthalmos. BCC occurred most frequently in the lower lid within the periorbital area. Rotation advancement of cheek flap with horizontal shift of the skin is most effective procedure in both appearance and function of the eyelid. PMID:19801921

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

    PubMed

    Wilder, Rebecca S; Bray, Kimberly S

    2016-06-01

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

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

    PubMed Central

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

    2003-01-01

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

  17. Amebic liver abscess: epidemiology, clinical features, and outcome.

    PubMed Central

    Seeto, R K; Rockey, D C

    1999-01-01

    Amebic liver abscess (ALA) is a serious, but readily treatable form of hepatic infection. In order to understand the clinical features of this condition in the United States, we reviewed the medical histories of 56 patients with ALA at two large San Francisco Hospitals from 1979 to 1994. Patients were divided into the following groups based on the presumed manner in which they had acquired ALA: those born or raised in the United States, with a history of travel to an endemic area (Tr-ALA); those from an endemic area, but living in the United States for less than one year (En-ALA); and those neither from nor having traveled to an endemic area (N-ALA). We found distinct clinical patterns in patients from different epidemiological groups. Patients with Tr-ALA were a decade older than those from endemic regions, were more likely to be male, and tended to have an insidious onset. Furthermore, compared to patients with En-ALA, those with Tr-ALA were more likely to have hepatomegaly (P < 0.0001) and large abscesses (ALA > 10 cm; P < 0.01). One third of the patients studied had no associated travel history or endemic origin as risk factors. Of these, 63% had a condition consistent with severe immunosuppression, such as infection with the human immunodeficiency virus (HIV), malnourishment with severe hypoalbuminemia, or chronic infection. In patients with N-ALA, the presence of a presumed immunosuppressed state increased significantly, as compared to patients with endemic or travel risk factors for ALA. During the last five years of the study, one third of all patients diagnosed with ALA were HIV positive (including 2 with a new diagnosis of AIDS), many of whom were discovered to be HIV-infected only after presentation with ALA. We conclude that travel to and origin in an endemic area are important risk factors for the development of ALA, and patients in these different epidemiological groups appear to have distinct clinical features. Further, in the absence of recognized

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

    PubMed Central

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

    2015-01-01

    This study presents clinical outcomes of primary cleft palate surgery, including rate of oronasal fistula development, rate of velopharyngeal insufficiency (VPI) requiring secondary surgery, and speech outcomes. We examined the effect of cleft type on the clinical outcomes. Retrospective analysis was performed using clinical records of all patients who received a primary palatoplasty at the Cleft Palate Clinic at Seoul Asan Medical Center, South Korea, between 2007 and 2012. The study included 292 patients with nonsyndromic overt cleft palate (±cleft lip). The results revealed that the rate of oronasal fistula was 7.9% and the incidence of VPI based on the rate of secondary palatal surgery was 19.2%. The results showed that 50.3% of all the patients had received speech therapy and 28.8% and 51.4% demonstrated significant hypernasality and articulatory deficits, respectively. The results of the rate of VPI and speech outcomes were significantly different in terms of cleft type. Except for the rate of oronasal fistula, patients with cleft palate generally exhibited better clinical outcomes compared to those with bilateral or unilateral cleft lip and palate. This study suggests that several factors, including cleft type, should be identified and comprehensively considered to establish an optimal treatment regimen for patients with cleft palate. PMID:26273593

  19. Clinical outcomes of childhood x-irradiation for lymphoid hyperplasia

    SciTech Connect

    Pottern, L.M.

    1987-01-01

    A prospective study was conducted to explore the relationship between childhood x-irradiation for lymphoid hyperplasia and the subsequent development of thyroid gland and other head and neck disorders. All individuals under 18 years of age who were x-irradiated for lymphoid hyperplasia during the years 1938-69 at Children's Hospital Medical Center, Boston comprised the exposed population. The comparison group consisted of non-exposed, surgically treated individuals. The study included a health questionnaire and a clinical examination component. A history of thyroid cancer was reported by 11 exposed subjects and no non-exposed subjects. Significantly elevated standardized incidence ratios of thyroid cancer were seen for both exposed males and females, 19.9 and 12.1, respectively. The average thyroid radiation dose was 25.8 rads and the mean latency period was 17.3 years.

  20. Clinical characteristics, treatment patterns and outcomes of Hispanic hypertensive patients.

    PubMed

    Campbell, Patrick T; Krim, Selim R; Lavie, Carl J; Ventura, Hector O

    2014-01-01

    Hispanics are the largest and fastest-growing minority population in the United States, currently comprising about 16.3% (52 million) of the total population. With an increased prevalence of metabolic risk factors in this population, the rate of uncontrolled hypertension (HTN) in Hispanics significantly exceeds the rates observed among non-Hispanic blacks and whites. Unfortunately, data on HTN in Hispanics remains limited due to the under-representation of Hispanics in clinical trials; with most of the data primarily restricted to observational and retrospective subgroup analyses. This article aims to review the available data on prevalence, awareness and control of HTN, risk factors and some of the challenges unique to the Hispanics population. We also discuss treatment strategies derived from large HTN trials that included Hispanics. PMID:25537632

  1. The clinical outcome of 137 rape victims in Hong Kong.

    PubMed

    Chu, L C; Tung, W K

    2005-10-01

    From 1 August 2001 to 31 July 2004, 137 patients were referred from the Association Concerning Sexual Violence Against Women to the Accident and Emergency Department at the Kwong Wah Hospital for alleged rape. Approximately half of the patients presented within 3 days of the alleged assault. Fifty-one patients were prescribed emergency contraception: one patient remained pregnant despite treatment and was referred with a further six patients to the Gynaecology Department for termination of pregnancy. Thirty-two patients received hepatitis B immunoglobulin injection. One patient had a positive result for rapid plasma reagin 3 months following the assault and was referred to the Social Hygiene Clinic. All tests for antibody to human immunodeficiency virus were negative. Antimicrobial therapy was prescribed for women who had an endocervical and/or high vaginal swab positive for Chlamydia trachomatis (n=9), Trichomonas vaginalis (n=1), and gonococcus (n=1). PMID:16219959

  2. Postoperative biological and clinical outcomes following uncomplicated pancreaticoduodenectomy

    PubMed Central

    Lermite, Emilie; Wu, Tao; Sauvanet, Alain; Mariette, Christophe; paye, François; Muscari, Fabrice; Cunha, Antonio Sa; Sastre, Bernard; Arnaud, Jean-Pierre

    2016-01-01

    Backgrounds/Aims The aim of this study was to describe clinical and biological changes in a group of patients who underwent pancreaticoduodenectomy (PD) without any complication during the postoperative period. These changes reflect the "natural history" of PD, and a deviation should be considered as a warning sign. Methods Between January 2000 and December 2009, 131 patients underwent PD. We prospectively collected and retrospectively analyzed demographic data, pathological variables, associated pathological conditions, and preoperative, intraoperative, and postoperative variables. Postoperative variables were validated using an external prospective database of 158 patients. Results The mean postoperative length of hospital stay was 20.3±4 days. The mean number of days until removal of nasogastric tube was 6.3±1.6 days. The maximal fall in hemoglobin level occurred on day 3 and began to increase after postoperative day (POD) 5, in patients with or without transfusions. The white blood cell count increased on POD 1 and persisted until POD 7. There was a marked rise in aminotransferase levels at POD 3. The peak was significantly higher in patients with hepatic pedicle occlusion (866±236 IU/L versus 146±48 IU/L; p<0.001). For both γ-glutamyl transpeptidase and alkaline phosphatase, there was a fall on POD1, which persisted until POD 5, followed with a stabilization. Bilirubin decreased progressively from POD 1 onwards. Conclusions This study facilitates a standardized biological and clinical pathway of follow-up. Patients who do not follow this recovery indicator could be at risk of complications and additional exams should be made to prevent consequences of such complications. PMID:26925147

  3. Association of perpetrator relationship to abusive head trauma clinical outcomes.

    PubMed

    Scribano, Philip V; Makoroff, Kathi L; Feldman, Kenneth W; Berger, Rachel P

    2013-10-01

    The diagnosis of abusive head trauma (AHT) remains a significant public health problem with limited prevention success. Providing protection from further harm is often challenged by the difficulty in identifying the alleged perpetrator (AP) responsible for this pediatric trauma. The objective of this study was to evaluate demographic and clinical characteristics of children with AHT and the relationship between APs and their victims in a large, multi-site sample. Understanding the AHT risks from various caregivers may help to inform current prevention strategies. A retrospective review of all cases of AHT diagnosed by child protection teams (CPT) from 1/1/04 to 6/30/09 at four children's hospitals was conducted. Clinical characteristics of children with AHT injured by non-parental perpetrators (NPP) were compared to parental perpetrators (PP). There were 459 children with AHT; 313 (68%) had an identified AP. The majority of the 313 children were <1 year of age (76%), Caucasian (63%), male (58%), receiving public assistance (80%), and presented without a history of trauma (62%); mortality was 19%. Overall, APs were: father (53%), parent partner (22%), mother (8%), babysitter (8%), other adult caregiver (5%); NPP accounted for 39% of APs. NPPs were more likely to cause AHT in children ≥ 1 year (77% vs. 23%, p<0.001) compared to PP. Independent associations to NPP included: older child, absence of a history of trauma, retinal hemorrhages, and male perpetrator gender. While fathers were the most common AP in AHT victims, there is a significant association for increased risk of AHT by NPPs in the older child, who presents with retinal hemorrhages, in the hands of a male AP. Further enhancement of current prevention strategies to address AHT risks of non-parental adults who provide care to children, especially in the post-infancy age seems warranted. PMID:23735871

  4. Predicting MCI outcome with clinically available MRI and CSF biomarkers

    PubMed Central

    Heister, D.; Brewer, J.B.; Magda, S.; Blennow, K.

    2011-01-01

    Objective: To determine the ability of clinically available volumetric MRI (vMRI) and CSF biomarkers, alone or in combination with a quantitative learning measure, to predict conversion to Alzheimer disease (AD) in patients with mild cognitive impairment (MCI). Methods: We stratified 192 MCI participants into positive and negative risk groups on the basis of 1) degree of learning impairment on the Rey Auditory Verbal Learning Test; 2) medial temporal atrophy, quantified from Food and Drug Administration–approved software for automated vMRI analysis; and 3) CSF biomarker levels. We also stratified participants based on combinations of risk factors. We computed Cox proportional hazards models, controlling for age, to assess 3-year risk of converting to AD as a function of risk group and used Kaplan-Meier analyses to determine median survival times. Results: When risk factors were examined separately, individuals testing positive showed significantly higher risk of converting to AD than individuals testing negative (hazard ratios [HR] 1.8–4.1). The joint presence of any 2 risk factors substantially increased risk, with the combination of greater learning impairment and increased atrophy associated with highest risk (HR 29.0): 85% of patients with both risk factors converted to AD within 3 years, vs 5% of those with neither. The presence of medial temporal atrophy was associated with shortest median dementia-free survival (15 months). Conclusions: Incorporating quantitative assessment of learning ability along with vMRI or CSF biomarkers in the clinical workup of MCI can provide critical information on risk of imminent conversion to AD. PMID:21998317

  5. Clinical Outcomes and Toxicity of Proton Radiotherapy for Breast Cancer.

    PubMed

    Verma, Vivek; Shah, Chirag; Mehta, Minesh P

    2016-06-01

    Proton beam radiotherapy (PBT) represents a rapidly expanding modality for the treatment of several malignancies. We examined the current state of PBT for breast cancer to evaluate its role in the modern era of breast radiotherapy. Systematic searches were performed using PubMed, EMBASE, and abstracts from the American Society for Radiation Oncology, American Society of Clinical Oncology, and Particle Therapy Co-Operative Group of North America annual meetings, using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. Nine original investigations were analyzed. Despite the dearth of overall data, skin toxicity after PBT might be equivalent or better than that of photons. Conventionally fractionated breast/chest wall PBT produces grade 1 dermatitis rates of approximately 25% and grade 2 dermatitis in 71% to 75%. This is comparable or improved over the published rates for photons. The incidence of esophagitis was decreased if the target coverage was compromised in the medial supraclavicular volume, a finding that echoes previous results with photon radiotherapy. The rates of esophagitis were also comparable to the previous data for photons. Using PBT-based accelerated partial breast irradiation, the rates of seroma/hematoma and fat necrosis were comparable to those reported in the existing data. Radiation pneumonitis and rib fractures remain rare. PBT offers excellent potential to minimize the risk of cardiac events, keeping the mean heart dose at ≤ 1 Gy. However, definitive clinical experiences remain sparse. The recently begun randomized trial of protons versus photons will further aid in providing robust conclusions. PMID:26995159

  6. Clinical outcome and follow-up of prenatal hydronephrosis.

    PubMed

    Asl, Afshin Safaei; Maleknejad, Shohreh

    2012-05-01

    Hydronephrosis is probably the most common congenital abnormality detected prenatally by ultrasonography This study was performed to determine the cause and outcome of prenatal hydronephrosis in our hospital. A total of 45 infants, with 57 prenatally hydronephrotic renal units, were enrolled into this study. For the purpose of this study, the degree of hydronephrosis was defined as mild, moderate or severe. Postnatal ultrasonography was performed as soon as possible in those with bilateral hyronephrosis and 3-7 days after birth in those with unilateral hydronephrosis. Voiding cystourethrogram was performed in 6-8 weeks time. In the absence of vesicoureteral reflux (VUR), diethylenetriamene penta acetate scan was performed to exclude obstructive uropathy. There were 29 males and 16 females (male:female ratio 1.8:1), and unilateral and bilateral hydronephrosis were seen in 33 (73%) and 12 (27%) of the cases, respectively. Hydronephrosis was caused by ureteropelvic junction obstruction (UPJO) in 20 (44.5%), VUR in 10 (22.2%), ureterovesical junction obstruction in four (8.9 %), posteriorurethral valves in four (8.9 %), UPJO with VUR in two (4.4%) and non-VUR non-obstructive in one (2.2%). During follow-up, 16 patients (35.5%) required operative intervention while seven (15.5%) improved spontaneously. Fetal hydronephrosis needs close follow-up during both ante-natal and postnatal periods. In this study, the most common cause for hydronephrosis were UPJO and VUR. Also seen in this study is the noteworthy point that mild fetal hydronephrosis is relatively benign and does not require surgical intervention in most cases and surgery should be performed only if there is renal function compromise. Prenatal consultation with a pediatric nephrologist and urologist is useful in decreasing parental anxiety and facilitating postnatal management. PMID:22569439

  7. Clinical characteristics and surgical outcomes of pediatric rhegmatogenous retinal detachment.

    PubMed

    Gurler, Bulent; Coskun, Erol; Öner, Veysi; Comez, Aysegul; Erbagci, Ibrahim

    2016-08-01

    The objective of this study was to analyze the characteristics and surgical results of pediatric rhegmatogenous retinal detachment (RRD). The medical records of 30 eyes of 29 patients younger than 18 years of age who underwent vitreoretinal surgery due to RRD were analyzed. The gender, age, laterality, duration of presenting symptom, etiology, ocular and systemic co-morbidities, type of breaks, lens status, presence of proliferative vitreoretinopathy (PVR) and its grade, initial and final best-corrected visual acuities (BCVAs), surgical management, number of operations, duration of follow-up, functional and anatomical success, and complications were noted. As the most common predisposing factors were trauma (trauma group) and myopia (myopia group), the data of these patients were further analyzed. The mean age was 12.6 ± 3.0 years. There were 23 male (79.3 %) and 6 female (20.6 %) subjects. The most common etiologic factors were high myopia (40 %) and trauma (36.6 %). Functional success rate was 70 % (n = 21) after the primary surgeries and was 80 % (n = 24) after the secondary surgeries. There were no significant differences between the trauma and myopia groups regarding the presence of total retinal detachment, macula-off status, and the rate of PVR worse than grade C. Although the preoperative mean BCVA and the initial and final retinal reattachment rates of the groups were statistically similar, trauma group had significantly higher postoperative mean BCVA compared to myopia group (p = 0.013). Myopia and trauma were the most common etiologic factors for RRD in children. The visual outcomes of trauma-associated RRD were better than those of myopia-associated RRD. PMID:26627689

  8. Costs and clinical outcomes for non-invasive versus invasive diagnostic approaches to patients with suspected in-stent restenosis

    PubMed Central

    Hasegawa, James T.; Machacz, Susanne F.; O’Day, Ken

    2015-01-01

    This study compared costs and clinical outcomes of invasive versus non-invasive diagnostic evaluations for patients with suspected in-stent restenosis (ISR) after percutaneous coronary intervention. We developed a decision model to compare 2 year diagnosis-related costs for patients who presented with suspected ISR and were evaluated by: (1) invasive coronary angiography (ICA); (2) non-invasive stress testing strategy of myocardial perfusion imaging (MPI) with referral to ICA based on MPI; (3) coronary CT angiography-based testing strategy with referral to ICA based on CCTA. Costs were modeled from the payer’s perspective using 2014 Medicare rates. 56 % of patients underwent follow-up diagnostic testing over 2 years. Compared to ICA, MPI (98.6 %) and CCTA (98.1 %) exhibited lower rates of correct diagnoses. Non-invasive strategies were associated with reduced referrals to ICA and costs compared to an ICA-based strategy, with diagnostic costs lower for CCTA than MPI. Overall 2-year costs were highest for ICA for both metallic as well as BVS stents ($1656 and $1656, respectively) when compared to MPI ($1444 and $1411) and CCTA. CCTA costs differed based upon stent size and type, and were highest for metallic stents >3.0 mm followed by metallic stents <3.0 mm, BVS < 3.0 mm and BVS > 3.0 mm ($1466 vs. $1242 vs. $855 vs. $490, respectively). MPI for suspected ISR results in lower costs and rates of complications than invasive strategies using ICA while maintaining high diagnostic performance. Depending upon stent size and type, CCTA results in lower costs than MPI. PMID:26335370

  9. 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

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

    PubMed

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

    2008-07-01

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

  11. Improving Heart Failure Outcomes: The Role of the Clinical Nurse Specialist.

    PubMed

    Coen, Jennifer; Curry, Kimberly

    2016-01-01

    This article identifies and explains barriers to optimal outcomes of heart failure and the role of the clinical nurse specialist in overcoming these obstacles, improving patient outcomes and quality of life. In recent years, advances in heart failure management have increased survival rates, and as a result, the number of patients requiring services to manage disease progression and the complex array of symptoms associated with end-stage heart disease. Management of the heart failure patient is dependent on the severity of the disease and wide range of available treatment regimens. Disease progression can be unpredictable and treatment regimens increasingly complex. The authors present a typical case of a patient with heart failure, identify the barriers to optimal outcomes in managing heart failure, as well as describe the roles of the clinical nurse specialist in overcoming these barriers within 3 spheres of clinical nurse specialist influence: patient, health care provider, and health care systems. The clinical nurse specialist role is ideally suited to positively affect heart failure outcomes. These positive effects are drawn from the dynamic and unique nature of the clinical nurse specialist role and are perpetrated through the 3 spheres of clinical nurse specialist practice: patient, health care provider, and heath care system. PMID:27575796

  12. St John's wort (Hypericum perforatum): drug interactions and clinical outcomes

    PubMed Central

    Henderson, L; Yue, Q Y; Bergquist, C; Gerden, B; Arlett, P

    2002-01-01

    Aims The aim of this work is to identify the medicines which interact with the herbal remedy St John's wort (SJW), and the mechanisms responsible. Methods A systematic review of all the available evidence, including worldwide published literature and spontaneous case reports provided by healthcare professionals and regulatory authorities within Europe has been undertaken. Results A number of clinically significant interactions have been identified with prescribed medicines including warfarin, phenprocoumon, cyclosporin, HIV protease inhibitors, theophylline, digoxin and oral contraceptives resulting in a decrease in concentration or effect of the medicines. These interactions are probably due to the induction of cytochrome P450 isoenzymes CYP3A4, CYP2C9, CYP1A2 and the transport protein P-glycoprotein by constituent(s) in SJW. The degree of induction is unpredictable due to factors such as the variable quality and quantity of constituent(s) in SJW preparations. In addition, possible pharmacodynamic interactions with selective serotonin re-uptake inhibitors and serotonin (5-HT1d) receptor-agonists such as triptans used to treat migraine were identified. These interactions are associated with an increased risk of adverse reactions. Conclusions In Sweden and the UK the potential risks to patients were judged to be significant and therefore information about the interactions was provided to health care professionals and patients. The product information of the licensed medicines involved has been amended to reflect these newly identified interactions and SJW preparations have been voluntarily labelled with appropriate warnings. PMID:12392581

  13. IFN-gamma determines distinct clinical outcomes in autoimmune encephalomyelitis.

    PubMed

    Wensky, Allen K; Furtado, Glaucia C; Marcondes, Maria Cecilia Garibaldi; Chen, Shaohua; Manfra, Denise; Lira, Sergio A; Zagzag, David; Lafaille, Juan J

    2005-02-01

    Experimental autoimmune encephalomyelitis (EAE) is an inflammatory disease of the CNS initiated by autoreactive CD4(+) T cells. EAE classically presents with a progressive ascending paralysis and is a model of multiple sclerosis that recapitulates some aspects of the disease. In this report we describe a mouse strain that spontaneously develops a severe, nonclassical form of EAE with 100% incidence. The distinct clinical phenotype is marked initially by a slight head tilt, progressing to a severe head tilt, spinning, or a rotatory motion. Classical EAE spontaneously occurs in myelin basic protein (MBP)-specific TCR transgenic RAG-1(-/-) mice (referred to as T/R(-)), whereas nonclassical EAE spontaneously occurs in T/R(-) IFN-gamma(-/-) mice (T/R(-)gamma(-)). Thus, the TCR recognizes the same Ag (MBP) and uses identical TCR in both cases. The cellular infiltrate in nonclassical EAE is predominantly found in the brainstem and cerebellum, with very little inflammation in the spinal cord, which is primarily affected in classical disease. Importantly, depending on the genetic makeup and priming conditions of the MBP-specific T cells, nonclassical disease can occur in the presence of an inflammatory infiltrate with eosinophilic, neutrophilic, or monocytic characteristics. Finally, we believe that nonclassical spontaneous EAE could be a useful model for the study of some characteristics of multiple sclerosis not observed in classical EAE, such as the inflammatory responses in the brainstem and cerebellum that can cause vertigo. PMID:15661899

  14. BEHAVIORAL OUTCOMES OF MONOAMINE OXIDASE DEFICIENCY: PRECLINICAL AND CLINICAL EVIDENCE

    PubMed Central

    Bortolato, Marco; Shih, Jean C.

    2012-01-01

    Monoamine oxidase (MAO) isoenzymes A and B are mitochondrial-bound proteins, catalyzing the oxidative deamination of monoamine neurotransmitters as well as xenobiotic amines. Although they derive from a common ancestral progenitor gene, are located at X-chromosome and display 70% structural identity, their substrate preference, regional distribution, and physiological role are divergent. In fact, while MAO-A has high affinity for serotonin and norepinephrine, MAO-B primarily serves the catabolism of 2-phenylethylamine (PEA) and contributes to the degradation of other trace amines and dopamine. Convergent lines of preclinical and clinical evidence indicate that variations in MAO enzymatic activity—due to either genetic or environmental factors—can exert a profound influence on behavioral regulation and play a role in the pathophysiology of a large spectrum of mental and neurodegenerative disorders, ranging from antisocial personality disorder to Parkinson’s disease. Over the past few years, numerous advances have been made in our understanding of the phenotypical variations associated with genetic polymorphisms and mutations of the genes encoding for both isoenzymes. In particular, novel findings on the phenotypes of MAO-deficient mice are highlighting novel potential implications of both isoenzymes in a broad spectrum of mental disorders, ranging from autism and anxiety to impulse-control disorders and ADHD. These studies will lay the foundation for future research on the neurobiological and neurochemical bases of these pathological conditions, as well as the role of gene × environment interactions in the vulnerability to several mental disorders. PMID:21971001

  15. Clinical Course and Outcomes of Late Kidney Allograft Dysfunction

    PubMed Central

    Zakharov, Vadym; Ksenofontova, Anna; Onishchenko, Eugene; Golubova, Tatyana; Kichatyi, Sergey; Zakharova, Olga

    2016-01-01

    Background. This study is provided to increase the efficiency of the treatment of kidney transplant recipients by predicting the development of the late allotransplant dysfunction. Methods. 330 patients who have lived for more than one year with functioning kidney allograft were evaluated. To predict the subsequent duration of the well-functioning of allotransplant the prognostic significance of 15 baseline clinical and sociodemographic characteristics on the results of the survey one year after transplantation was investigated. The result was considered to be positive in constructing the regression prognostication model if recipient lived more than 3 years from the time of transplantation. Results. It was established that more late start of renal allograft dysfunction after transplantation correlates with the more time it takes till complete loss of allograft function. Creatinine and hemoglobin blood concentration and the level of proteinuria one year after transplantation within created mathematical model allow predicting the loss of kidney transplant function three years after the transplantation. Patients with kidney transplant dysfunction are advised to renew the program hemodialysis upon reaching plasma creatinine concentration 0.5–0.7 mmol/L. Conclusion. Values of creatinine, hemoglobin, and proteinuria one year after transplantation can be used for subsequent prognostication of kidney transplant function. PMID:27478631

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

    PubMed

    Peterson, Sarah J; Braunschweig, Carol A

    2016-02-01

    Sarcopenia refers to age-associated decrease in muscle mass and function. The condition was originally described in the elderly, but emerging evidence suggests that it is also a concern among the chronically ill nonelderly. Currently there are a number of definitions for diagnosing sarcopenia; however, in the clinical setting, abdominal computed tomography (CT) scans completed for diagnostic purposes can be utilized to identify CT-defined sarcopenia. Recent studies suggest that prevalence of CT-defined sarcopenia is high among chronically ill patients, ranging from 15%-50% in patients with cancer, 30%-45% with liver failure, and 60%-70% for critically ill patients in the intensive care unit. Depleted muscle mass is associated with infectious complications, prolonged duration of mechanical ventilation, longer hospitalization, greater need for rehabilitation care after hospital discharge, and higher mortality. In consideration of the growing population of older adults with multiple comorbidities, more research is needed to identify sarcopenia and develop interventions that are directed at attenuating or reversal muscle loss. PMID:26703961

  17. Clinical outcomes of suture delay in forehead flap.

    PubMed

    Isik, Daghan; Kiroglu, Faruk; Isik, Yasemin; Goktas, Ugur; Atik, Bekir

    2012-01-01

    The delay phenomenon is a surgical procedure performed to raise a wider skin flap and to improve the survival of skin flaps. Surgery, chemicals, sutures, and lasers can be used for the delay procedure. In this study, delayed forehead flaps created by suturing were used for coverage of nasal skin defects in eleven patients. In 7 patients, the cross-paramedian forehead flap was used to increase the extent of flap lengthening. In the first session, suture delay was performed on both sides of the forehead flap margin. In the second session, the flap was elevated and sutured to its new position, 7 to 10 days after the initial surgery. All flaps were completely viable, and patient satisfaction was optimal in all cases. The positive effect of surgical delay on flap survival has been shown in experimental and clinical studies. However, experimentally, suture delay or chemical delay procedures have been shown to be beneficial in flap survival only. Suture delay seems to be an inexpensive, effective, easily performed, atraumatic, and safe technique, especially among patients with systemic diseases such as diabetes or cardiovascular diseases, smoking patients who may lose the flap, or patients who need very wide and long flaps. PMID:22337378

  18. Can adventurous training have a role in improving clinical outcomes?

    PubMed

    Mellor, A; Jackson, S; Hardern, R

    2012-06-01

    The aim of military adventurous training (AT) is "to develop, through authorised challenging pursuits and within an outdoor environment, leadership and the qualities necessary to enhance the performance of military personnel during peace and war". An increasing amount of effort is being applied by all three services to increase participation in AT to achieve these, largely immeasurable, aims. Existing guidance to Commanding Officers dictates that, where possible, 20% of a unit strength should undertake some form of AT annually with 5% taking part in an overseas expedition. In a speech in 2008 Alan Johnson, the then Secretary of State for Health, acknowledged that for Armed Forces medical personnel 'just as important as clinical skills are issues such as leadership, communication, adaptability and teamwork." Controlled exposure to risk, discomfort and personal hardship is a common theme for both AT activities and military deployments. Both General Medical Council competencies for all doctors and the Royal College of Anaesthetists military module include elements which can effectively be taught and developed through training in an outdoors environment. These skills include communication skills, leadership, risk assessment and interdisciplinary working. In this review the value of AT in training doctors to develop those attributes is examined. PMID:22860500

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

    PubMed

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

    1993-10-01

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

  20. Effectiveness of structured hourly nurse rounding on patient satisfaction and clinical outcomes.

    PubMed

    Brosey, Lisa A; March, Karen S

    2015-01-01

    Structured hourly nurse rounding is an effective method to improve patient satisfaction and clinical outcomes. This program evaluation describes outcomes related to the implementation of hourly nurse rounding in one medical-surgical unit in a large community hospital. Overall Hospital Consumer Assessment of Healthcare Providers and Systems domain scores increased with the exception of responsiveness of staff. Patient falls and hospital-acquired pressure ulcers decreased during the project period. PMID:25237791

  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. PMID:27550490

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

    PubMed

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

    2016-06-01

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

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

    PubMed Central

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

    2016-01-01

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

  4. Collaboration in research: testing the PIPC model on clinical and nonclinical outcomes.

    PubMed

    Lengacher, C A; Mabe, P R; Heinemann, D; VanCott, M L; Kent, K; Swymer, S

    1997-01-01

    This outcomes research used a collaborative framework between a college of nursing and a medical center to test the effects of the Partners in Patient Care delivery model (PIPC) on clinical and nonclinical outcomes. An experimental pretest-postest design was used to compare selected nonclinical outcomes and clinical outcomes of care in two patient units. Results showed that there were significant differences between units in the nonclinical outcomes of nurse satisfaction, salary costs, supply costs, and productivity as measured by documentation time. In addition, there were significant differences in the clinical outcomes of care in terms of patient satisfaction. No significant differences were found in number of falls, medication errors, and intravenous infections; however, when ratios of these indicators were examined in relation to patient days, significant differences in the medication error ratio and the fall ratio were revealed. The results indicate that the PIPC delivery model did have positive effects on patient satisfaction and nurse satisfaction but that there were increased costs and increased time spent in documentation on the pilot unit. PMID:9171689

  5. Splenic abscess: clinical features, microbiologic finding, treatment and outcome.

    PubMed

    Sangchan, Apichat; Mootsikapun, Piroon; Mairiang, Pisaln

    2003-05-01

    Splenic abscess is a rare clinical entity but may be underreported. A retrospective study at Srinagarind Hospital revealed 60 cases of splenic abscess between 1992 and 2001. The causative organisms were identified in 41 cases (68.3%). Gram negative bacilli were commonly isolated and Burkholderia pseudomallei was the most predominant. Diabetes mellitus and leukemia were common underlying diseases found in 46.3 per cent and 9.7 per cent of culture confirmed cases, respectively. The patients usually presented with fever, left upper quadrant pain, tenderness and splenomegaly. Multiple abscesses were more commonly found in the melioidosis than in the non-melioidosis group (p = 0.032), but a single abscess was more commonly found in the non-melioidosis than in the melioidosis group (p = 0.032). Concurrent liver abscesses, often multiple, were not different in both groups. Antimicrobials alone were given in 66.7 per cent of cases with melioidosis and 64.7 per cent of non-melioidosis group. Splenectomy and percutaneous aspiration were performed only in 29.3 per cent and 4.9 per cent of cases with splenic abscess. The overall mortality rate of splenic abscess was only 4.9 per cent in the present series. In conclusion, splenic abscess is not uncommon. Burkholderia pseudomalleli is the most common causative agent found in the present series. Therefore, it should be targeted in the initial empirical antibiotic therapy before the culture results are available especially when multiple lesions in the spleen and concurrent multiple liver abscesses are seen. Prolonged treatment with appropriate antimicrobials alone is usually effective. Splenectomy and/or aspiration may be useful in selected patients. PMID:12859100

  6. Bilateral Chronic Subdural Hematoma is Associated with Rapid Progression and Poor Clinical Outcome

    PubMed Central

    AGAWA, Yuji; MINEHARU, Yohei; TANI, Shoichi; ADACHI, Hidemitsu; IMAMURA, Hirotoshi; SAKAI, Nobuyuki

    2016-01-01

    Chronic subdural hematoma (CSDH) has been recognized as a benign disease, but its clinical outcome is not well documented. This study aims to expand the knowledge base regarding the outcome of CSDH. We retrospectively reviewed clinical characteristics of CSDH operated in the Kobe City Medical Center General Hospital between June 2005 and June 2012. Variants included age at onset, sex, laterality, presence of headache, consciousness level, and risk factors for hemorrhage such as malignancy or intake of anticoagulants. A total of 368 cases were analyzed. Six patients (1.4%) had a poor outcome, defined as any morbidity or mortality at 7 days postoperatively. Bilateral hematoma was significantly associated with a poor outcome (p = 0.041). Warfarin use and malignancy, albeit statistically not significant, were more frequently observed in patients with a poor outcome. Bilateral CSDH was observed in 53 patients (14.4%). Age at onset, sex, history of malignancy, anticoagulant use, and antiplatelet use did not differ between bilateral and unilateral CSDH. Recurrence rate was not different between bilateral and unilateral CSDH (14.2% vs. 11.3%), but poor outcome as a result of brain herniation was significantly higher in bilateral than in unilateral hematomas (5.7% vs. 0.3%, p = 0.01). Bilateral CSDH was associated with rapid progression and showed worse outcome as a result of brain herniation in comparison with unilateral CSDH. Urgent trephination surgery for decompression of hematoma pressure may be recommended for bilateral CSDH. PMID:26923835

  7. Evaluation of NOC standardized outcome of "health seeking behavior" in nurse-managed clinics.

    PubMed

    Macnee, Carol L; Edwards, Joellen; Kaplan, Amy; Reed, Sue; Bradford, Susanne; Walls, Jennie; Schaller-Ayers, Jennifer M

    2006-01-01

    This study evaluated the accomplishment of the Nursing Outcomes Classification (NOC) outcome "Health Seeking Behavior" in 5 nurse-managed clinics. Nurse practitioners and registered nurses rated patients on 11 indicators of health seeking behaviors, and recorded their level of knowledge of the patient. A total of 556 evaluations were collected. Health seeking behavior scores were lowest in a rural county school-based clinic and highest in a federally qualified health center. Ratings increased with nurses' knowledge of patients and for older patients. PMID:16816605

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

    SciTech Connect

    Chadha, M.; Coderre, J.A.; Chanana, A.D.

    1996-12-31

    A phase I/II trial delivering a single fraction of BNCT using p-Boronophenylalanine-Fructose and epithermal neutrons at the the Brookhaven Medical Research Reactor was initiated in September 1994. The primary endpiont of the study was to evaluate the feasibility and safety of a given BNCT dose. The clinical outcome of the disease was a secondary endpoint of the study. The objective of this paper is to evaluate the correlation of the clinical outcome of patients to the estimated radiation dose from BNCT.

  9. Clinical outcome of small hepatocellular carcinoma after different treatments: A meta-analysis

    PubMed Central

    Dong, Wei; Zhang, Ting; Wang, Zhen-Guang; Liu, Hui

    2014-01-01

    AIM: To compare clinical outcomes between surgical resection (RES) and nonsurgical-RES (nRES) ablation therapies for small hepatocellular carcinoma (HCC). METHODS: MEDLINE, Embase and Cochrane Library databases were systematically searched for studies of RES and nRES treatments for small HCC between January 2003 and October 2013. The clinical outcome measures evaluated included overall survival rate, disease-free survival rate, adverse events, and local recurrence rate. Odds ratios (ORs) with 95%CIs were calculated using either the fixed effects model or random effects model. The χ2 and I2 tests were calculated to assess the heterogeneity of the data. Funnel plots were used to assess the risk of publication bias. RESULTS: Our analysis included 12 studies that consisted of a total of 1952 patients (RES vs nRES), five studies that consisted of 701 patients [radiofrequency ablation (RFA) vs percutaneous ethanol injection (PEI)], and five additional studies [RFA vs RFA + transcatheter arterial chemoembolization (TACE)] that all addressed the treatment of small HCC. For cases of RES vs nRES, there was no significant difference in the 1-year (OR = 0.99, 95%CI: 0.87-1.12, P = 0.85) or 3-year (OR = 0.97, 95%CI: 0.84-1.11, P = 0.98) overall survival rate; however, there was a significant increase in the RES group in the 5-year overall survival rate (OR = 0.81, 95%CI: 0.68-0.95, P = 0.01). The 1-year (OR = 0.94, 95%CI: 0.82-1.08, P = 0.37) and 5-year (OR = 0.99, 95%CI: 0.85-1.14, P = 0.85) disease-free survival rates showed no significant differences between the two groups. The 3-year disease-free survival rate (OR = 0.81, 95%CI: 0.69-0.96; P = 0.02) was higher in the RES group. For cases of RFA vs PEI, our data analysis indicated that RFA treatment was associated with significantly higher 2-year (OR = 0.76, 95%CI: 0.58-0.99, P = 0.043) and 3-year (OR = 0.73, 95%CI: 0.54-0.98, P = 0.039) overall survival rates; however, there were no significant differences in the 1-year

  10. Clinical Outcomes in Men and Women following Total Knee Arthroplasty with a High-Flex Knee: No Clinical Effect of Gender

    PubMed Central

    Nassif, Jeffrey M.; Pietrzak, William S.

    2015-01-01

    While it is generally recognized that anatomical differences exist between the male and female knee, the literature generally refutes the clinical need for gender-specific total knee prostheses. It has been found that standard, unisex knees perform as well, or better, in women than men. Recently, high-flex knees have become available that mechanically accommodate increased flexion yet no studies have directly compared the outcomes of these devices in men and women to see if gender-based differences exist. We retrospectively compared the performance of the high-flex Vanguard knee (Biomet, Warsaw, IN) in 716 male and 1,069 female knees. Kaplan-Meier survivorship was 98.5% at 5.6–5.7 years for both genders. After 2 years, mean improvements in Knee Society Knee and Function scores for men and women (50.9 versus 46.3; 26.5 versus 23.1) and corresponding SF-12 Mental and Physical scores (0.2 versus 2.2; 13.7 versus 12.2) were similar with differences not clinically relevant. Postoperative motion gains as a function of preoperative motion level were virtually identical in men and women. This further confirms the suitability of unisex total knee prostheses for both men and women. PMID:26451389

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

    PubMed

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

    2011-12-01

    Statistical significance has been used extensively to evaluate the results of research studies. Nevertheless, it offers only limited information to clinicians. The assessment of clinical relevance can facilitate the interpretation of the research results into clinical practice. The objective of this study was to explore different methods to evaluate the clinical relevance of the results using a cross-sectional study as an example comparing different neck outcomes between subjects with temporomandibular disorders and healthy controls. Subjects were compared for head and cervical posture, maximal cervical muscle strength, endurance of the cervical flexor and extensor muscles, and electromyographic activity of the cervical flexor muscles during the CranioCervical Flexion Test (CCFT). The evaluation of clinical relevance of the results was performed based on the effect size (ES), minimal important difference (MID), and clinical judgement. The results of this study show that it is possible to have statistical significance without having clinical relevance, to have both statistical significance and clinical relevance, to have clinical relevance without having statistical significance, or to have neither statistical significance nor clinical relevance. The evaluation of clinical relevance in clinical research is crucial to simplify the transfer of knowledge from research into practice. Clinical researchers should present the clinical relevance of their results. PMID:21658987

  12. Plasma C-Reactive Protein and Clinical Outcomes after Acute Ischemic Stroke: A Prospective Observational Study

    PubMed Central

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

    2016-01-01

    Background and Purpose Although plasma C-reactive protein (CRP) is elevated in response to inflammation caused by brain infarction, the association of CRP with clinical outcomes after acute ischemic stroke remains uncertain. This study examined whether plasma high-sensitivity CRP (hsCRP) levels at onset were associated with clinical outcomes after acute ischemic stroke independent of conventional risk factors and acute infections after stroke. Methods We prospectively included 3653 patients with first-ever ischemic stroke who had been functionally independent and were hospitalized within 24 h of onset. Plasma hsCRP levels were measured on admission and categorized into quartiles. The association between hsCRP levels and clinical outcomes, including neurological improvement, neurological deterioration, and poor functional outcome (modified Rankin scale ≥3 at 3 months), were investigated using a logistic regression analysis. Results Higher hsCRP levels were significantly associated with unfavorable outcomes after adjusting for age, sex, baseline National Institutes of Health Stroke Scale score, stroke subtype, conventional risk factors, intravenous thrombolysis and endovascular therapy, and acute infections during hospitalization (multivariate-adjusted odds ratios [95% confidence interval] in the highest quartile versus the lowest quartile as a reference: 0.80 [0.65–0.97] for neurological improvement, 1.72 [1.26–2.34] for neurological deterioration, and 2.03 [1.55–2.67] for a poor functional outcome). These associations were unchanged after excluding patients with infectious diseases occurring during hospitalization, or those with stroke recurrence or death. These trends were similar irrespective of stroke subtypes or baseline stroke severity, but more marked in patients aged <70 years (Pheterogeneity = 0.001). Conclusions High plasma hsCRP is independently associated with unfavorable clinical outcomes after acute ischemic stroke. PMID:27258004

  13. Evaluation of the Outcome-Present State Test Model as a way to teach clinical reasoning.

    PubMed

    Bartlett, Robin; Bland, Ann; Rossen, Eileen; Kautz, Donald; Benfield, Susan; Carnevale, Teresa

    2008-08-01

    The Outcome-Present State Test (OPT) Model of Clinical Reasoning is a nursing process model designed to help students develop clinical reasoning skills. Although many nurse educators are using the OPT model as a teaching strategy, few are formally evaluating its use as a method. We used the OPT model as a teaching tool in an undergraduate psychiatric and mental health clinical nursing course and evaluated how quickly students became adept at using it. Most students mastered the use of the model; 29 of 43 students achieved the criterion score (a score greater than 65 on 3 or more models completed over 4 weeks). Not only did the students gain clinical reasoning skills, but they also used and learned more about the North American Nursing Diagnosis Association, Nursing Interventions Classification, and Nursing Outcomes Classification languages. Recommendations for future use of the model include adding client strengths and increasing focus on the quality of students' responses. PMID:18751647

  14. Is the Perinatal Outcome of Placental Abruption Modified by Clinical Presentation?

    PubMed Central

    Furukawa, Seishi; Sameshima, Hiroshi; Ikenoue, Tsuyomu; Ohashi, Masanao; Nagai, Yoshio

    2011-01-01

    Objective. The purpose of this study was to elucidate the impact of the clinical presentation on perinatal outcome in placental abruption. Study Design. A retrospective study was performed in 97 placental abruptions. Placental abruptions were classified according to clinical presentation: pregnancy-induced hypertension (HT, n = 22), threatened premature labor and/or premature rupture of membranes (TPL/ROM, n = 35), clinically low risk (LR, n = 27), and others (n = 13). Perinatal outcomes were compared among the HT, TPL/ROM, and LR groups. Results. The HT had significantly higher incidence of IUGR, IFUD, and low fibrinogen. The TPL/ROM had less severe disease. However, the LR had significantly higher incidence of IUFD, low UA pH < 7.1, low Apgar score of <7 at 5 min, and low fibrinogen. Conclusion. Disease severity in placental abruption is likely to depend on the clinical presentation. PMID:21490793

  15. Beyond the "acid test": a conceptual review and reformulation of outcome evaluation in clinical supervision.

    PubMed

    Milne, Derek

    2014-01-01

    Theoretical models abound within clinical supervision, but these rarely have been applied to supervision evaluation. Instead, it appears that reviewers and researchers have simply transferred to supervision the conceptual frameworks used within medicine, especially the idea that clinical outcomes are the "acid test" of supervisory effectiveness or quality. Following a careful examination of the key literature, in this paper I argue that this has led to an over-emphasis on clinical outcomes, with the net effect of reducing scientific confidence, understanding, and the effectiveness of supervision. To begin to rectify this bias, an augmented fidelity framework is used to reformulate evaluation, drawing on some of the key concepts guiding evaluation within related fields (i.e. service evaluation; staff development; psychotherapy; applied research). The resulting evaluation model is specific to clinical supervision and can help to increase our understanding, enhance our practice, re-prioritise research, and inspire confidence in supervision. PMID:25122986

  16. Nursing home-acquired pneumonia: outcomes from a clinical process improvement program.

    PubMed

    Dempsey, C L

    1995-01-01

    At EHS Christ Hospital and Medical Center, an eight-step process improvement model was developed that incorporates continuous quality improvement concepts for monitoring, evaluating and improving patient care. Nursing home residents admitted with pneumonia were identified as the group having the most influence on mortality and costs associated with treatment of pneumonia at our hospital. A multidisciplinary team evaluated clinical resource use and patient care processes, and identified root causes of various influencing treatment. Clinical guidelines were created and outcomes were defined, resulting in significant improvement in the clinical management of these patients. Average length of stay decreased from 8.6 days in 1992 to 7.6 days in 1993, with a charge reduction of $1830 per patient. The methodologic framework of a process improvement program combines epidemiologic, clinical, and quality improvement sciences. This mix is essential in improving patient care and quantifying outcomes. PMID:7753691

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

    PubMed Central

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

    2011-01-01

    This paper outlines the clinical application of CBCT for assessment of treatment outcomes, and discusses current work to superimpose digital dental models and 3D photographs. Superimposition of CBCTs on stable structures of reference now allow assessment of 3D dental, skeletal and soft tissue changes for both growing and non-growing patients. Additionally, we describe clinical findings from CBCT superimpositions in assessment of surgery and skeletal anchorage treatment. PMID:21516170

  18. Relationship between Lesion Topology and Clinical Outcome In Anterior Circulation Large Vessel Occlusions

    PubMed Central

    Rangaraju, Srikant; Streib, Christopher; Aghaebrahim, Amin; Jadhav, Ashutosh; Frankel, Michael; Jovin, Tudor G.

    2015-01-01

    Background and purpose Diffusion-weighted imaging (DWI) ASPECTS, a surrogate of infarct volume, predicts outcome in anterior large vessel occlusion (LVO) strokes. We aim to determine whether topological information captured by DWI ASPECTS contributes additional prognostic value. Methods Adults with intracranial ICA, M1 or M2 MCA occlusions who underwent endovascular therapy were included. The primary outcome measure was poor clinical outcome (3-month modified Rankin Scale score 3–6). Prognostic value of the 10 DWI ASPECTS regions in predicting poor outcome was determined by multivariable logistic regression, controlling for final infarct volume, age and laterality. Results 213 patients (mean age 66.1±14.5 years, median NIHSS 15) were included. Inter-rater reliability was good for DWI ASPECTS (Deep regions: Kappa=0.72, Cortical regions: Kappa=0.63). All DWI ASPECTS regions with the exception of the putamen were significant predictors (p<0.05) of poor outcome in univariate analyses. Statistical collinearity among ASPECTS regions was not observed. Using penalized multivariable logistic regression, only M4 (OR=2.82 95%CI 1.39–5.76) and M6 (OR=2.45, 95%CI 1.15–5.3) involvement were associated with poor outcome. M6 involvement independently predicted poor outcome in right hemispheric strokes (OR=5.8, 95%CI 1.9–20.3) whereas M4 (OR=4.3, 95%CI 1.3–15.0) involvement predicted poor outcome in left hemispheric strokes adjusting for infarct volume. Topologic information modestly improved the predictive ability of a prognostic score that incorporates age, infarct volume and hemorrhagic transformation. Conclusions Involvement of the right parieto-occipital (M6) and left superior-frontal (M4) regions impact clinical outcome in anterior LVOs over and above the effect of infarct volume and should be considered during prognostication. PMID:26060248

  19. Severe hypoxaemia can predict unfavourable clinical outcomes in individuals with pulmonary embolism aged over 40 years

    PubMed Central

    Souza, Caio Simoes; Resende, Fernanda Simoes Seabra; Rodrigues, Marcelo Palmeira

    2014-01-01

    INTRODUCTION Acute pulmonary embolism (APE) is an urgent clinical condition that can progress in a wide variety of ways. Therefore, we sought to develop an easy-to-apply algorithm, to be based on readily available clinical indicators, effective in predicting unfavourable outcomes. METHODS This was a retrospective cohort study based on systematically collected data in a database. The study included 102 patients with APE who were admitted to a tertiary care hospital. The following outcomes were defined as unfavourable shock, the need for mechanical ventilation, the use of thrombolytics, and death. Logistic regression analysis was used to explore variables significantly associated with outcome and to calculate post-test probabilities. RESULTS The prevalence of unfavourable outcomes was 25.5% (26 of the 102 patients with APE). The risk of an unfavourable outcome was reduced to 7.0% for patients with APE who were aged ≤ 40 years. In patients with APE who were aged > 40 years, the presence of hypoxaemia (i.e. peripheral oxygen saturation < 90%) alone increased the risk of an unfavourable outcome to 57.0%. A recent history of trauma and the presence of pre-existing lung or heart disease were significantly associated with unfavourable outcomes. The inclusion of those variables in the logistic regression model increased the post-test risk of an unfavourable outcome to 65.0%–86.0%. CONCLUSION Advanced age (i.e. > 40 years), the presence of hypoxaemia, a recent history of trauma and the presence of pre-existing lung or heart disease are risk factors for unfavourable outcome in patients with APE. PMID:25273933

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

    PubMed Central

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

    2016-01-01

    Objective. To evaluate radiographic and clinical outcomes up to 24 months in patients with RA enrolled in the Canadian Methotrexate and Etanercept Outcome study. Methods. In this open-label non-inferiority trial, patients with inadequate response to MTX received etanercept plus MTX for 6 months and then were randomized to either etanercept monotherapy or continued etanercept plus MTX until 24 months. Radiographic data were analysed using the modified total Sharp score (mTSS), joint space narrowing and erosion scores. Secondary outcomes included the 28-joint DAS with ESR (DAS28-ESR), Simplified Disease Activity Index, Clinical Disease Activity Index, HAQ Disability Index (HAQ-DI) and safety. Results. Two hundred five of 258 patients enrolled were randomized (98 etanercept, 107 etanercept plus MTX). At month 24, the mean increase from baseline to month 24 for the etanercept and etanercept plus MTX arms, respectively, for the mTSS were 0.4 (s.d. 1.9) and 0.0 (s.d. 1.4); for joint space narrowing, 0.1 (s.d. 0.6) and 0.0 (s.d. 0.7) and for erosion, 0.3 (s.d. 1.5) and 0.0 (s.d. 1.0). At month 24, the mean increase from month 6 mean scores/count increases for DAS28-ESR were 0.56 (s.d. 1.26) and 0.08 (s.d. 1.50); for Simplified Disease Activity Index, 4.7 (s.d. 13.1) and 0.9 (s.d. 12.5); for Clinical Disease Activity Index, 4.1 (s.d. 12.3) and 1.0 (s.d. 12.3) and for HAQ-DI, 0.20 (s.d. 0.45) and 0.02 (s.d. 0.54). Patients with DAS28-ESR low disease activity (LDA)/remission at month 6 had numerically better outcomes at month 24 than patients with moderate to high disease activity at month 6. In patients with LDA/remission at month 6, outcomes were similar at month 24 between etanercept monotherapy and etanercept plus MTX, whereas patients with moderate to high disease activity at month 6 had numerically better outcomes with etanercept plus MTX than etanercept at month 24. There were no new safety signals and serious adverse events were not different between groups

  1. An assessment of HIV treatment outcomes among utilizers of semi-mobile clinics in rural Kenya.

    PubMed

    Gorman, Sara E; Martinez, Jose M; Olson, Jennifer

    2015-01-01

    HIV/AIDS is a major cause of morbidity and mortality in Africa, and rates of retention in treatment are low. Some research has shown that mobile clinics are effective in connecting people in rural areas with health care. We compared HIV outcomes between HIV-positive patients who chose to access treatment from a regional hospital to those who chose care in one of four semi-mobile clinics closer to where they live. The subjects for this analysis were HIV-positive residents in West Pokot accessing care at one of four semi-mobile sites (Kabichbich, Chepareria, Kacheliba, and Sigor) or at the regional hospital in Kapenguria. We examined four outcome variables between the two groups: (1) retention in HIV treatment, (2) change in CD4 count, (3) adherence to ARVs, and (4) deaths. The patients who chose semi-mobile clinic care were less well educated, poorer, and sicker than those who chose to continue care in the regional hospital. There were no statistically significant differences between the groups in any of the four outcome measures. Although the population of patients attending semi-mobile clinics was on average poorer and sicker than those attending the hospital, their outcomes were similar. Care at the semi-mobile clinics did not result in significantly different outcomes from care in the district hospital. This program showed that semi-mobile clinics are a viable alternative to hospital care for very ill, isolated populations, but further measures must be taken to improve retention and adherence in these settings. PMID:25495796

  2. Is Toxoplasma gondii type related to clinical outcome in human congenital infection? Systematic and critical review.

    PubMed

    Rico-Torres, C P; Vargas-Villavicencio, J A; Correa, D

    2016-07-01

    In human congenital toxoplasmosis the effects of parasite burden and pregnancy time at infection on clinical outcome are well known, but there is controversy regarding the role of Toxoplasma gondii type. Through a systematic review of the literature, we aimed to discern if T. gondii type has a role on clinical outcome in human congenital toxoplasmosis. We built up a database of congenital toxoplasmosis from reports of cases, case series and screening-based cohorts, which had information about parasite type, gestation time at maternal infection and/or clinical outcome in the product. Then, we obtained frequencies for loci used to genotype geographical origin of cases and types found. Also, odds ratios were calculated for association between time of maternal infection or parasite type on outcome. Type II parasites were the most common in Europe, Asia and Africa, while in America there were mainly atypical strains. More newborns with clinical problems were born from mothers infected during the first half of gestation than from those acquiring the parasite after week 24, regardless of parasite genotype (92.9 vs. 16.1 %, OR = 67.9, CI95 25.4-181.6). Type I and atypical parasites were associated with clinical problems as opposed to types II and III, regardless of pregnancy period at infection (86.9 vs. 72.9 %, OR = 2.47, CI95 1.1-5.4). A significant and remarkable tendency of type I parasites to be present during early pregnancy was also observed (94.4 vs. 5.6 %, P < 0.009). In addition to parasite burden and period of gestation, T. gondii genotype seems involved in CT clinical outcome. PMID:27146878

  3. 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

  4. Impact of Ultrahigh Baseline PSA Levels on Biochemical and Clinical Outcomes in Two Radiation Therapy Oncology Group Prostate Clinical Trials

    SciTech Connect

    Rodrigues, George; Bae, Kyounghwa; Roach, Mack; Lawton, Colleen; Donnelly, Bryan; Grignon, David; Hanks, Gerald; Porter, Arthur; Lepor, Herbert; Sandler, Howard

    2011-06-01

    Purpose: To assess ultrahigh (UH; prostate-specific antigen [PSA]levels {>=}50 ng/ml) patient outcomes by comparison to other high-risk patient outcomes and to identify outcome predictors. Methods and Materials: Prostate cancer patients (PCP) from two Phase III Radiation Therapy Oncology Group clinical trials (studies 9202 and 9413) were divided into two groups: high-risk patients with and without UH baseline PSA levels. Predictive variables included age, Gleason score, clinical T stage, Karnofsky performance score, and treatment arm. Outcomes included overall survival (OS), distant metastasis (DM), and biochemical failure (BF). Unadjusted and adjusted hazard ratios (HRs) were calculated using either the Cox or Fine and Gray's regression model with associated 95% confidence intervals (CI) and p values. Results: There were 401 patients in the UH PSA group and 1,792 patients in the non-UH PSA PCP group of a total of 2,193 high-risk PCP. PCP with UH PSA were found to have inferior OS (HR, 1.19; 95% CI, 1.02-1.39, p = 0.02), DM (HR, 1.51; 95% CI, 1.19-1.92; p = 0.0006), and BF (HR, 1.50; 95% CI, 1.29-1.73; p < 0.0001) compared to other high-risk PCP. In the UH cohort, PSA level was found to be a significant factor for the risk of DM (HR, 1.01; 95% CI, 1.001-1.02) but not OS and BF. Gleason grades of 8 to 10 were found to consistently predict for poor OS, DM, and BF outcomes (with HR estimates ranging from 1.41-2.36) in both the high-risk cohort and the UH cohort multivariable analyses. Conclusions: UH PSA levels at diagnosis are related to detrimental changes in OS, DM, and BF. All three outcomes can be modeled by various combinations of all predictive variables tested.

  5. Live Birth is the Correct Outcome for Clinical Trials Evaluating Therapy for the Infertile Couple

    PubMed Central

    Barnhart, Kurt T.

    2014-01-01

    Well-designed and conducted clinical trials are needed to further advance the field for reproductive medicine. However current reporting of outcomes of trials is ambiguous and disparate. In this manuscript it is offed that the preferred outcome for clinical trials in reproductive medicine should be live birth. Multiple births should be listed and it should be specified whether this is multiple births per couple or multiple births per conception. The unit of measure should be women (or couples) and not cycles. The duration of exposure should also be clearly identified (i.e., treatment was one cycle, a pre-specified number of cycles, or a period of time). Pregnancy loss should be specified and the denominator should be those who conceived. While live birth is the primary outcome, complications should be defined and reported including multiple births and other objective markers such as preterm delivery, small-for-gestational age, or stillbirth. PMID:24786740

  6. Mechanical thrombectomy in pediatric acute ischemic stroke: Clinical outcomes and literature review.

    PubMed

    Madaelil, Thomas P; Kansagra, Akash P; Cross, DeWitte T; Moran, Christopher J; Derdeyn, Colin P

    2016-08-01

    There are limited data on outcomes of mechanical thrombectomy for pediatric stroke using modern devices. In this study, we report two cases of pediatric acute ischemic stroke treated with mechanical thrombectomy, both with good angiographic result (TICI 3) and clinical outcome (no neurological deficits at 90 days). In addition, we conducted a literature review of all previously reported cases describing the use of modern thrombectomy devices. Including our two cases, the aggregate rate of partial or complete vessel recanalization was 100% (22/22), and the aggregate rate of favorable clinical outcome was 91% (20/22). This preliminary evidence suggests that mechanical thrombectomy with modern devices may be a safe and effective treatment option in pediatric patients with acute ischemic stroke. PMID:26945589

  7. Craniotomy or Decompressive Craniectomy for Acute Subdural Hematomas: Surgical Selection and Clinical Outcome

    PubMed Central

    Kwon, Young Sub; Yang, Kook Hee

    2016-01-01

    Objective Craniotomy (CO) and decompressive craniectomy (DC) are two main surgical options for acute subdural hematomas (ASDH). However, optimal selection of surgical modality is unclear and decision may vary with surgeon's experience. To clarify this point, we analyzed preoperative findings and surgical outcome of patients with ASDH treated with CO or DC. Methods From January 2010 to December 2014, data for 46 patients with ASDH who underwent CO or DC were retrospectively reviewed. The demographic, clinical, imaging and clinical outcomes were analyzed and statistically compared. Results Twenty (43%) patients underwent CO and 26 (57%) patients received DC. In DC group, preoperative Glascow Coma Scale was lower (p=0.034), and more patient had non-reactive pupil (p=0.004). Computed tomography findings of DC group showed more frequent subarachnoid hemorrhage (p=0.003). Six month modified Rankin Scale showed favorable outcome in 60% of CO group and 23% of DC group (p=0.004). DC was done in patient with more unfavorable preoperative features (p=0.017). Patients with few unfavorable preoperative features (<6) had good outcome with CO (p<0.001). Conclusion In selective cases of few unfavorable clinical findings, CO may also be an effective surgical option for ASDH. Although DC remains to be standard of surgical modality for patients with poor clinical status, CO can be an alternative considering the possible complications of DC. PMID:27182498

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

    PubMed Central

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

    2016-01-01

    Among critically ill patients with lower respiratory tract (LRT)-confirmed influenza, we retrospectively observed worse 28-day clinical outcomes in upper respiratory tract (URT)-negative versus URT-positive subjects. This finding may reflect disease progression and highlights the need for influenza testing of both URT and LRT specimens to improve diagnostic yield and possibly inform prognosis. PMID:26966696

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

    PubMed Central

    Pantazis, Konstantinos

    2016-01-01

    Objectives. The purpose of the present study was to investigate the clinical outcomes and complications of the cortical button distal biceps fixation method. Material and Methods. All methods followed the PRISMA guidelines. Included studies had to describe clinical outcomes and complications after acute distal biceps repair with cortical button fixation. Eligibility criteria also included English language, more than 5 cases with minimum follow-up of 6 months, and preferably usage of at least one relevant clinical score (MEPS, ASES, and/or DASH) for final outcome. A loss of at least 30° in motion—flexion, extension, pronation, or supination—and a loss of at least 30% of strength were considered an unsatisfactory result. Results. The review identified 7 articles including 105 patients (mean age 43.6 years) with 106 acute distal biceps ruptures. Mean follow-up was 26.3 months. Functional outcome of ROM regarding flexion/extension and pronation/supination was satisfactory in 94 (89.5%) and 86 (82%) patients in respect. Averaged flexion and supination strength had been reported in 6/7 studies (97 patients) and were satisfactory in 82.4% of them. The most common complication was transient nerve palsy (14.2%). The overall reoperation rate was 4.8% (5/105 cases). Conclusion. Cortical button fixation for acute distal biceps repair is a reproducible operation with good clinical results. Most of the complications can be avoided with appropriate surgical technique. PMID:27525303

  10. Characterization of Potential Outcome Measures for Future Clinical Trials in Fragile X Syndrome

    ERIC Educational Resources Information Center

    Berry-Kravis, Elizabeth; Sumis, Allison; Kim, Ok-Kyung; Lara, Rebecca; Wuu, Joanne

    2008-01-01

    Clinical trials targeting recently elucidated synaptic defects in fragile X syndrome (FXS) will require outcome measures capable of assessing short-term changes in cognitive functioning. Potentially useful measures for FXS were evaluated here in a test-retest setting in males and females with FXS (N = 46). Good reproducibility, determined by an…

  11. Poststroke Shoulder Pain in Turkish Stroke Patients: Relationship with Clinical Factors and Functional Outcomes

    ERIC Educational Resources Information Center

    Barlak, Aysegul; Unsal, Sibel; Kaya, Kurtulus; Sahin-Onat, Sule; Ozel, Sumru

    2009-01-01

    The objective of this study was to assess the possible causes of hemiplegic shoulder pain (HSP) in Turkish patients with stroke, to identify the correlation between HSP and clinical factors, and to review the effects of HSP on functional outcomes. A total of 187 consecutive patients with stroke were evaluated for the presence of HSP and for the…

  12. Functional outcome measures for NF1-associated optic pathway glioma clinical trials

    PubMed Central

    Avery, Robert A.; Allen, Jeffrey C.; Ardern-Holmes, Simone L.; Bilaniuk, Larissa T.; Ferner, Rosalie E.; Gutmann, David H.; Listernick, Robert; Martin, Staci; Ullrich, Nicole J.; Liu, Grant T.

    2013-01-01

    Objective: The goal of the Response Evaluation in Neurofibromatosis and Schwannomatosis Visual Outcomes Committee is to define the best functional outcome measures for future neurofibromatosis type 1 (NF1)-associated optic pathway glioma (OPG) clinical trials. Methods: The committee considered the components of vision, other ophthalmologic parameters affected by OPG, potential biomarkers of visual function, and quality of life measures to arrive at consensus-based, evidence-driven recommendations for objective and measurable functional endpoints for OPG trials. Results: Visual acuity (VA) assessments using consistent quantitative testing methods are recommended as the main functional outcome measure for NF1-OPG clinical trials. Teller acuity cards are recommended for use as the primary VA endpoint, and HOTV as a secondary endpoint once subjects are old enough to complete it. The optic disc should be assessed for pallor, as this appears to be a contributory variable that may affect the interpretation of VA change over time. Given the importance of capturing patient-reported outcomes in clinical trials, evaluating visual quality of life using the Children's Visual Function Questionnaire as a secondary endpoint is also proposed. Conclusions: The use of these key functional endpoints will be essential for evaluating the efficacy of future OPG clinical trials. PMID:24249802

  13. Clinical profile and treatment outcome of older (>75 years) patients with systemic AL amyloidosis

    PubMed Central

    Sachchithanantham, Sajitha; Offer, Mark; Venner, Christopher; Mahmood, Shameem A.; Foard, Darren; Rannigan, Lisa; Lane, Thirusha; Gillmore, Julian D.; Lachmann, Helen J.; Hawkins, Philip N.; Wechalekar, Ashutosh D.

    2015-01-01

    Systemic AL amyloidosis, a disease with improving outcomes using novel therapies, is increasingly recognized in the elderly but treatment and outcomes have not been systematically studied in this group of patients in whom comorbidities and frailty may compound morbidity and mortality. We report the outcomes of 295 patients with systemic AL amyloidosis ≥75 years seen at the UK National Amyloidosis Centre from 2005–2012. The median age was 78.5 years. The median overall survival was 20 months. Two hundred and thirty-eight patients received chemotherapy and 57 elected for supportive care only (overall survival – 24 and 8.4 months, respectively). On intention-to-treat analysis, 44% achieved a hematologic response including a very good partial response or better in 23%. The median overall survival was 6.2 years in patients achieving very good partial response or better at the 6-month landmark analysis and 1.5 years in non-responders. Factors independently indicating a poor prognosis were: cardiac involvement, performance status ≥2; systolic blood pressure <100 mmHg and, on landmark analysis, achieving less than a very good partial response. Treatment of systemic AL amyloidosis in the elderly is challenging. Deep clonal responses are associated with excellent survival and organ responses. Achieving a response to the first-line regimen appears particularly important as outcomes of non-responders are similar to those of untreated patients. Prospective trials with lower toxicity, outpatient treatment regimens are needed. PMID:26294730

  14. Clinical characteristics and post-surgical outcomes of focal cortical dysplasia subtypes.

    PubMed

    Xue, Hai; Cai, Lixin; Dong, Sheng; Li, Yongjie

    2016-01-01

    We retrospectively studied 105 patients with a focal cortical dysplasia (FCD) diagnosed on pathological examination, and investigated the long term postoperative seizure outcomes, different clinical characteristics of the three FCD subtypes, particularly type I and II, and surgical outcomes for each group. FCD is a common cause of drug-resistant epilepsy, which is divided into three different subtypes according to its involvement at different stages of brain development. Each of these groups may have different characteristics and may even have different surgical outcomes. After treatment, 55% of patients were completely seizure-free, with two significant predictive variables for poorer outcomes: focal MRI findings and electrode implantation. FCD type I had relatively poor surgical outcomes compared to FCD type II and type IIIa. Compared with FCD type I, type II, particularly IIb, had a higher frequency of seizure attacks, predominantly located in the extratemporal lobes, and was more readily detected and diagnosed via focal lesions on MRI and localized electroencephalogram abnormalities. FCD type II patients seem to show better surgical outcomes than FCD type I, but the difference was not significant. Larger cohort studies are needed for further evaluation of the seizure outcomes of different FCD subtypes. PMID:26314661

  15. Early prediction of neurological outcome after falls in children: metabolic and clinical markers.

    PubMed Central

    Paret, G; Tirosh, R; Lotan, D; Stein, M; Ben-Abraham, R; Vardi, A; Harel, R; Barzilay, Z

    1999-01-01

    Falls are the foremost reason for non-fatal injuries and are second only to motor vehicle accidents in causing accidental death. The purpose of this study was to identify the clinical and metabolic predictors of the outcome of head injury caused by falls from a height. Medical records of 61 children who had been admitted to the paediatric intensive care unit from 1990 to 1993 after falling from a height were reviewed retrospectively. Outcomes were categorised as good, moderate, severe, and poor. Glasgow coma scores, pupillary responses, brain oedema, and midline shift are significantly associated with poor outcome (p < 0.05). Metabolic markers associated with poor outcome included hyperglycaemia and hypokalaemia. Children with a poor outcome had, at admission, significantly higher glucose concentrations compared with children with good outcomes (mean SD): 20.0 (7.1) v 9.31 (4.0) mmol/l, p < 0.01), and lower potassium concentrations compared with children with good, moderate, and severe outcomes (mean (SD): 2.8 (0.4) v 3.7 (0.4) mmol/l, p < 0.001, 3.5 (0.3) mmol/l, p < 0.01, and 3.41 (0.3) mmol/l, p < 0.05, respectively). These findings allow for an early allocation of effort and resources to children injured from such falls. Images Figure 1 Figure 2 PMID:10353044

  16. Low Mitochondrial DNA Copy Number is Associated With Adverse Clinical Outcomes in Peritoneal Dialysis Patients.

    PubMed

    Yoon, Chang-Yun; Park, Jung Tak; Kee, Youn Kyung; Han, Seung Gyu; Han, In Mee; Kwon, Young Eun; Park, Kyoung Sook; Lee, Mi Jung; Han, Seung Hyeok; Kang, Shin-Wook; Yoo, Tae-Hyun

    2016-02-01

    Mitochondrial dysfunction may play an important role in abnormal glucose metabolism and systemic inflammation. We aimed to investigate the relationship between mitochondrial DNA (mtDNA) copy number and clinical outcomes in peritoneal dialysis (PD) patients. We recruited 120 prevalent PD patients and determined mtDNA copy number by PCR. Primary outcome was all-cause mortality, whereas secondary outcomes included cardiovascular events, technical PD failure, and incident malignancy. Cox proportional hazards analysis determined the independent association of mtDNA copy number with outcomes. The mean patient age was 52.3 years; 42.5% were men. The mean log mtDNA copy number was 3.30 ± 0.50. During a follow-up period of 35.4 ± 19.3 months, all-cause mortality and secondary outcomes were observed in 20.0% and 59.2% of patients, respectively. Secondary outcomes were significantly lower in the highest mtDNA copy number group than in the lower groups. In multiple Cox analysis, the mtDNA copy number was not associated with all-cause mortality (lower two vs highest tertile: hazard ratio [HR] = 1.208, 95% confidence interval [CI] = 0.477-3.061). However, the highest tertile group was significantly associated with lower incidences of secondary outcomes (lower two vs highest tertile: HR [95% CI] = 0.494 [0.277-0.882]) after adjusting for confounding factors. The decreased mtDNA copy number was significantly associated with adverse clinical outcomes in PD patients. PMID:26886611

  17. Low Mitochondrial DNA Copy Number is Associated With Adverse Clinical Outcomes in Peritoneal Dialysis Patients

    PubMed Central

    Yoon, Chang-Yun; Park, Jung Tak; Kee, Youn Kyung; Han, Seung Gyu; Han, In Mee; Kwon, Young Eun; Park, Kyoung Sook; Lee, Mi Jung; Han, Seung Hyeok; Kang, Shin-Wook; Yoo, Tae-Hyun

    2016-01-01

    Abstract Mitochondrial dysfunction may play an important role in abnormal glucose metabolism and systemic inflammation. We aimed to investigate the relationship between mitochondrial DNA (mtDNA) copy number and clinical outcomes in peritoneal dialysis (PD) patients. We recruited 120 prevalent PD patients and determined mtDNA copy number by PCR. Primary outcome was all-cause mortality, whereas secondary outcomes included cardiovascular events, technical PD failure, and incident malignancy. Cox proportional hazards analysis determined the independent association of mtDNA copy number with outcomes. The mean patient age was 52.3 years; 42.5% were men. The mean log mtDNA copy number was 3.30 ± 0.50. During a follow-up period of 35.4 ± 19.3 months, all-cause mortality and secondary outcomes were observed in 20.0% and 59.2% of patients, respectively. Secondary outcomes were significantly lower in the highest mtDNA copy number group than in the lower groups. In multiple Cox analysis, the mtDNA copy number was not associated with all-cause mortality (lower two vs highest tertile: hazard ratio [HR] = 1.208, 95% confidence interval [CI] = 0.477–3.061). However, the highest tertile group was significantly associated with lower incidences of secondary outcomes (lower two vs highest tertile: HR [95% CI] = 0.494 [0.277–0.882]) after adjusting for confounding factors. The decreased mtDNA copy number was significantly associated with adverse clinical outcomes in PD patients. PMID:26886611

  18. Using evidence-based practice for managing clinical outcomes in advanced practice nursing.

    PubMed

    Glanville, I; Schirm, V; Wineman, N M

    2000-10-01

    Preparation of advanced practice nurses to assume leadership positions for clinical decision making requires that traditional ways of solving clinical problems be augmented with information from relevant, research-derived evidence. In this article, the authors describe how one graduate program prepares advanced practice nurses to use the best scientific evidence with clinical expertise to influence patient outcomes. The assignments that students complete in their program provide examples of evidence-based practice that apply quality improvement principles and science-based nursing interventions to create best practices. PMID:11008434

  19. Suspected acute exacerbation of idiopathic pulmonary fibrosis as an outcome measure in clinical trials

    PubMed Central

    2013-01-01

    Background Acute exacerbation of idiopathic pulmonary fibrosis has become an important outcome measure in clinical trials. This study aimed to explore the concept of suspected acute exacerbation as an outcome measure. Methods Three investigators retrospectively reviewed subjects enrolled in the Sildenafil Trial of Exercise Performance in IPF who experienced a respiratory serious adverse event during the course of the study. Events were classified as definite acute exacerbation, suspected acute exacerbation, or other, according to established criteria. Results Thirty-five events were identified. Four were classified as definite acute exacerbation, fourteen as suspected acute exacerbation, and seventeen as other. Definite and suspected acute exacerbations were clinically indistinguishable. Both were most common in the winter and spring months and were associated with a high risk of disease progression and short-term mortality. Conclusions In this study one half of respiratory serious adverse events were attributed to definite or suspected acute exacerbations. Suspected acute exacerbations are clinically indistinguishable from definite acute exacerbations and represent clinically meaningful events. Clinical trialists should consider capturing both definite and suspected acute exacerbations as outcome measures. PMID:23848435

  20. Surgical approach in primary total hip arthroplasty: anatomy, technique and clinical outcomes

    PubMed Central

    Petis, Stephen; Howard, James L.; Lanting, Brent L.; Vasarhelyi, Edward M.

    2015-01-01

    Total hip arthroplasty (THA) has revolutionized the treatment of hip arthritis. A number of surgical approaches to the hip joint exist, each with unique advantages and disadvantages. The most commonly used approaches include the direct anterior, direct lateral and posterior approaches. A number of technical intricacies allow safe and efficient femoral and acetabular reconstruction when using each approach. Hip dislocation, abductor insufficiency, fracture and nerve injury are complications of THA, although their relative risk varies by approach. Numerous clinical trials have sought to elicit differences in patient-reported outcomes, complication rates and return to function among the surgical approaches. This review outlines some of the technical pearls of performing a THA through either a direct anterior, direct lateral or posterior approach. A literature review outlines the impact of surgical approach on clinical outcomes and clinically relevant complication rates. PMID:25799249

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

    PubMed

    Hu, Bo; Li, Liang; Greene, Tom

    2016-07-30

    Longitudinal cohort studies often collect both repeated measurements of longitudinal outcomes and times to clinical events whose occurrence precludes further longitudinal measurements. Although joint modeling of the clinical events and the longitudinal data can be used to provide valid statistical inference for target estimands in certain contexts, the application of joint models in medical literature is currently rather restricted because of the complexity of the joint models and the intensive computation involved. We propose a multiple imputation approach to jointly impute missing data of both the longitudinal and clinical event outcomes. With complete imputed datasets, analysts are then able to use simple and transparent statistical methods and standard statistical software to perform various analyses without dealing with the complications of missing data and joint modeling. We show that the proposed multiple imputation approach is flexible and easy to implement in practice. Numerical results are also provided to demonstrate its performance. Copyright © 2015 John Wiley & Sons, Ltd. PMID:26179943

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

    PubMed

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

    2013-08-01

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

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

    PubMed

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

    2016-06-30

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

  4. Clinical Outcome Assessments: Conceptual Foundation–Report of the ISPOR Clinical Outcomes Assessment – Emerging Good Practices for Outcomes Research Task Force DOES THIS HAVE TO BE LABLED AS PART 1

    PubMed Central

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

    2015-01-01

    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 in order 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 in 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

  5. Clinical Neurochemistry of Subarachnoid Hemorrhage: Toward Predicting Individual Outcomes via Biomarkers of Brain Energy Metabolism.

    PubMed

    Tholance, Yannick; Barcelos, Gleicy; Dailler, Frederic; Perret-Liaudet, Armand; Renaud, Bernard

    2015-12-16

    The functional outcome of patients with subarachnoid hemorrhage is difficult to predict at the individual level. The monitoring of brain energy metabolism has proven to be useful in improving the pathophysiological understanding of subarachnoid hemorrhage. Nonetheless, brain energy monitoring has not yet clearly been included in official guidelines for the management of subarachnoid hemorrhage patients, likely because previous studies compared only biological data between two groups of patients (unfavorable vs favorable outcomes) and did not determine decision thresholds that could be useful in clinical practice. Therefore, this Viewpoint discusses recent findings suggesting that monitoring biomarkers of brain energy metabolism at the level of individuals can be used to predict the outcomes of subarachnoid hemorrhage patients. Indeed, by taking into account specific neurochemical patterns obtained by local or global monitoring of brain energy metabolism, it may become possible to predict routinely, and with sufficient sensitivity and specificity, the individual outcomes of subarachnoid hemorrhage patients. Moreover, combining both local and global monitoring improves the overall performance of individual outcome prediction. Such a combined neurochemical monitoring approach may become, after prospective clinical validation, an important component in the management of subarachnoid hemorrhage patients to adapt individualized therapeutic interventions. PMID:26595414

  6. Outcome of Endodontic Treatments Made by Postgraduate Students in the Dental Clinic of Bretonneau Hospital

    PubMed Central

    Touboul, Virginie; Germa, Alice; Lasfargues, Jean-Jacques; Bonte, Eric

    2014-01-01

    Objective. The objective of this retrospective study is double: (1) to assess the 1–4 years of outcome of endodontic treatment performed by postgraduate students in endodontics in the Dental Clinic of Bretonneau Hospital and (2) to examine outcome predictors. Method. 363 teeth in 296 patients were treated between 2007 and 2011. 183 patients (224 teeth) were lost during the followup. 113 patients were included in the study (recall: 38%), corresponding to 139 teeth of which 8 were extracted. 131 remaining teeth (36%) were examined clinically and radiographically. Apical periodontitis (AP) was absent (PAI = 1) or present (PAI ≥ 2). Outcome was classified as “healed,” “healing,” or “diseased”. Results. The success rate was 92%. No failure was observed among the 23 initial endodontic treatments. Among the 108 retreated teeth, 80% were “healed” and 11% were “healing.” An association was found between success rate and preoperative signs or symptoms (absent 95% versus present 83%), preoperative root filling density (inadequate 93% versus adequate 57%), but not between preoperative AP status and success. Conclusion. Outcomes in this retrospective study were similar to those previously reported. However, a larger sample size is needed to assess outcome predictors more precisely. PMID:24778652

  7. The Impact of Cannabis Use on Clinical Outcomes in Recent Onset Psychosis

    PubMed Central

    Barrowclough, Christine; Gregg, Lynsey; Lobban, Fiona; Bucci, Sandra; Emsley, Richard

    2015-01-01

    Background: There are inconsistencies in findings as to whether cannabis use has a negative impact on clinical outcomes for people with established psychosis. Effects may be more evident on patients with recent onset psychosis. Aim: To investigate the relationship between cannabis use and clinical outcome, including whether change in cannabis use affects psychotic symptoms, affective symptoms, functioning and psychotic relapse in a sample of people in early psychosis with comorbid cannabis abuse or dependence. Methods: One hundred and ten participants were examined prospectively with repeated measures of substance use antecedent to psychopathology at baseline, 4.5, 9, and 18 months. We used random intercept models to estimate the effects of cannabis dose on subsequent clinical outcomes and whether change in cannabis use was associated with change in outcomes. Results: There was no evidence of a specific association between cannabis use and positive symptoms, or negative symptoms, relapse or hospital admissions. However, a greater dose of cannabis was associated with subsequent higher depression and anxiety. Change in the amount of cannabis used was associated with statistically significant corresponding change in anxiety scores, but not depression. Additionally, reductions in cannabis exposure were related to improved patient functioning. Conclusions: Reducing cannabis may be directly associated with improvements in anxiety and functioning, but not other specific symptoms. PMID:25011381

  8. Impact of Net Atrioventricular Compliance on Clinical Outcome in Mitral Stenosis

    PubMed Central

    Nunes, Maria Carmo P.; Hung, Judy; Barbosa, Marcia M.; Esteves, William A.; Carvalho, Vinicius T.; Lodi-Junqueira, Lucas; Fonseca Neto, Cirilo P.; Tan, Timothy C.; Levine, Robert A.

    2014-01-01

    Background Net atrioventricular compliance (Cn) has been reported to be an important determinant of pulmonary hypertension in mitral stenosis (MS). We hypothesized that, as Cn reflects hemodynamic consequences of MS, it may be useful in assessing prognosis. To date, limited data with an assumed Cn cutoff have indicated the need for larger prospective studies. This prospective study was designed to determine the impact of Cn on clinical outcome and its contribution to pulmonary pressure in MS. In addition, we aimed to identify a cutoff value of Cn for outcome prediction in this setting. Methods and Results A total of 128 patients with rheumatic MS without other significant valve disease were prospectively enrolled. Comprehensive echocardiography was performed and Doppler-derived Cn estimated using a previously validated equation. The endpoint was either mitral valve intervention or death. Cn was an important predictor of pulmonary pressure, regardless of classic measures of MS severity. During a median follow-up of 22 months, the endpoint was reached in 45 patients (35%). Baseline Cn predicted outcome, adding prognostic information beyond that provided by mitral valve area and functional status. Cn ≤ 4 mL/mmHg best predicted unfavorable outcome in derivation and validation sets. A subgroup analysis including only initially asymptomatic patients with moderate to severe MS without initial indication for intervention (40.6 % of total) demonstrated that baseline Cn predicted subsequent adverse outcome even after adjusting for classic measures of hemodynamic MS severity (hazard ratio [HR] 0.33, 95% confidence interval [CI] 0.14–0.79, p = 0.013). Conclusions Cn contributes to pulmonary hypertension beyond of stenosis severity itself. In a wide spectrum of MS severity, Cn is a powerful predictor of adverse outcome, adding prognostic value to clinical data and mitral valve area. Importantly, baseline Cn predicts a progressive course with subsequent need for intervention

  9. Does Vertebral Endplate Morphology Influence Outcomes in Lumbar Total Disc Arthroplasty? Part II: Clinical and Radiographic Results as Evaluated Utilizing the Vertebral Endplate Yue-Bertagnoli (VEYBR) Classification

    PubMed Central

    Oetgen, Matthew E.; la Torre, Jorge J. Jaramillo-de; Bertagnoli, Rudolf

    2008-01-01

    Study Design This study was a prospective study with a minimum patient follow-up of 2 years. Objective The purpose of this study was to evaluate the clinical usefulness of a vertebral endplate classification system (VEYBR) in predicting outcomes following lumbar arthroplasty. Background In the present study, our previously described endplate classification system was evaluated to determine its clinical usefulness in patients undergoing lumbar arthroplasty. Methods The patient cohort in this study consisted of 80 patients who had been enrolled in the US FDA ProDisc clinical trial. Radiographs were classified using the VEYBR classification. The preoperative categories (Types I to V) were then correlated with the patients’ visual analogue scores (VAS) and Oswestry Disability Index (ODI) scores and radiographic outcomes at an average follow-up point of 28 months. Results The rank order of total change in VAS based on preoperative VEYBR classification was Type IV, III, I II, and V, with Type IV having the greatest improvement in VAS and Type V having the least improvement. The rank order of total change in ODI was Type IV, II, III, I, and V. We found no differences in clinical outcomes among the 5 vertebral endplate types. Type II endplates had least optimal sagittal positioning. Conclusions Although not statistically significant, there was a strong trend for Type V endplates to have the least improvements in VAS and Oswestry clinical outcome scores. Knowledge and use of the endplate classification system did lead to consistent implant placement across endplate classes which may indicate the usefulness of this classification system in preoperative planning, especially for physicians in the “learning curve” phase of this procedure. Level of Evidence Case series (Level IV). PMID:25802609

  10. Relationship between drug interactions and drug-related negative clinical outcomes

    PubMed Central

    Cremades, Javier; Gonzalo, Mario; Arrebola, Isabel

    2008-01-01

    Drug interactions may represent an iatrogenic risk that should be controlled in community pharmacies at the dispensing level. Aim We analyzed the association between potential drug-drug interactions (DDIs) and negative clinical outcomes. Methods We used dispensing data from two community pharmacies: instances where drug dispensing was associated with a potential DDI and a comparison group of randomized dispensing operations with no potential DDI. In cases where potential DDIs were detected, we analyzed the underlying negative clinical outcomes. Age and gender data were included in the analysis. Results During the study period, we registered 417 potential DDIs. The proportion of women and age were higher in the study group than in the comparison group. The average potential DDIs per patient was 1.31 (SD=0.72). The Consejo General de Colegios Oficiales de Farmacéuticos (CGCOF) database did not produce an alert in 2.4% of the cases. Over-the-counter medication use was observed in 5% of the potential DDI cases. The drugs most frequently involved in potential DDIs were acenocoumarol, calcium salts, hydrochlorothiazide, and alendronic acid, whereas the most predominant potential DDIs were calcium salts and bisphosphonates, oral antidiabetics and thiazide diuretics, antidiabetics and glucose, and oral anticoagulant and paracetamol. The existence of a drug-related negative clinical outcome was observed only in 0.96% of the potential DDI cases (50% safety cases and 50% effectiveness cases). Conclusions Only a small proportion of the detected potential DDIs lead to medication negative outcomes. Considering the drug-related negative clinical outcomes encountered, tighter control would be recommended in potential DDIs with NSAIDs or benzodiazepines. PMID:25147590

  11. 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. PMID:22945784

  12. Analysis of donor heterogeneity as a factor affecting the clinical outcome of oocyte donation.

    PubMed

    Harris, Sarah E; Faddy, Malcolm; Levett, Stephen; Sharma, Vinay; Gosden, Roger

    2002-11-01

    This study investigated factors that may affect the clinical outcome of oocyte donation on the basis of data from a clinical programme involving 243 treatment cycles analysed retrospectively. In each cohort, oocytes were distributed randomly to one, two or three recipients, which enabled the outcomes in terms of pregnancy and live birth rates to be compared among donors. The results were compared with respect to age of the donor and recipient, number of oocytes collected, fertilization and cleavage rates, qualitative embryo criteria (morphological grade) and other clinical criteria. Most variables had no significant effect on either outcome, although the live birth rate varied inversely with recipient age. Unsurprisingly, the pregnancy rate was correlated positively with the number of embryos transferred. Most of the variation in pregnancy and live birth rates (85-90%) could not be accounted for by any specific donation characteristic, indicating that interdonor heterogeneity was the result of idiopathic factors. The factor most predictive of a recipient's cycle outcome was a history of previous success of the donor, which accounted for approximately 30% of the variation in live birth rates. Pregnancy success rates varied widely among oocyte donors, as has been found among sperm donors. This observation highlights the need to identify markers that predict developmental competence and help to identify the genetic and environmental bases of differential fertility. In conclusion, the quality of oocytes varied widely among women presumed to be fertile by clinical criteria, and the causative factors set a major limitation on the prospects of improving the outcome of egg donation. PMID:12477962

  13. Clinical outcomes of CyberKnife stereotactic body radiotherapy for peripheral stage I non-small cell lung cancer.

    PubMed

    Shen, Ze-Tian; Wu, Xin-Hu; Li, Bing; Zhu, Xi-Xu

    2015-03-01

    The aim of this study was to evaluate the clinical outcome of CyberKnife stereotactic body radiotherapy (SBRT) for patients with stage I non-small cell lung cancer (NSCLC). Fifty patients with peripheral stage I NSCLC who refused surgery or were medically inoperable were treated with 48-60 Gy (median dose: 57 Gy) in three divided doses. Histopathology was available in 86% of patients. Thirty patients had a T1 tumor, and 20 patients had T2 tumors. More than 95% of the target volume was covered by the 72% isodose surface. Fiducials were implanted in or near the tumors in all patients to track tumor movement and breathing patterns. The median follow-up time was 35 months (3-45 months). Based on computed tomography scans, 40 patients achieved complete remission, six patients achieved partial remission, two patients exhibited stable disease, and two patients had progressive disease. The local control rate (CR + PR) was 92%, and the 2-year disease control rate (CR + PR + SD) was 96%. Overall survival for the whole group was 86% at 1 year and 74% at 2 years. Grade III toxicity occurred in two patients (4%) after marker placement. Treatment-related late grade III toxicity occurred in five patients (10%). Toxicities greater than grade III were not observed. CyberKnife SBRT achieves a high rate of local control and long-term curative effect with acceptable toxicity for patients with inoperable stage I NSCLC. However, long-term follow-up is necessary to evaluate survival and late toxicity. PMID:25638468

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

    PubMed Central

    Lin, Chia-Der; Lin, Blossom Yen-Ju; Lin, Cheng-Chieh; Lee, Cheng-Chun

    2015-01-01

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

  15. Clinical evaluation and outcomes of naturally acquired West Nile virus infection in raptors.

    PubMed

    Nemeth, Nicole M; Kratz, Gail E; Bates, Rebecca; Scherpelz, Judy A; Bowen, Richard A; Komar, Nicholas

    2009-03-01

    West Nile virus (WNV) infection and associated disease and mortality have been documented in numerous North American raptor species. Information regarding clinical presentations and long-term outcomes of WNV-infected raptors is important in the clinic for the diagnosis, treatment, and assessment of prognosis, as well as for understanding potential population level effects on raptor species. Raptors of 22 species admitted to a rehabilitation clinic were tested, from 2002 to 2005, for previous and acute WNV infection, while comparing clinical syndromes, trauma, and rehabilitation outcomes. Forty-two percent of admitted raptors (132/314) had been infected with WNV, and these presented with a WNV-attributed clinical disease rate of 67.4% (89/132). West Nile virus-infected raptors were less likely to be released (79/132 [59.8%]) than negative raptors (138/182 [75.8%]) and more likely to die or be euthanized (47/132 [35.6%] for WNV-infected vs. 32/182 [17.6%] for WNV-negative). However, WNV-infected raptors with neurologic disease were no less likely to be released (29/53 [54.7%]) than those without neurologic disease (50/79 [63.3%]). Clinical WNV-associated syndromes varied among species. Great horned owls (Bubo virginianus) were more likely to have neurologic signs, whereas American kestrels (Falco sparverius) and Swainson's hawks (Buteo swainsonii) were less likely to have neurologic signs. These results suggest that free-ranging raptors are frequently infected with WNV and that clinical syndromes differ among species. WNV has potentially devastating effects on raptors; however, rehabilitation of WNV-infected raptors can lead to positive outcomes, even for those having had severe neurologic disease. PMID:19368240

  16. Research Participant-Centered Outcomes at NIH-Supported Clinical Research Centers

    PubMed Central

    Kost, Rhonda G.; Lee, Laura N.; Yessis, Jennifer M.; Wesley, Robert; Alfano, Sandra; Alexander, Steven R.; Kassis, Sylvia Baedorf; Cola, Phil; Dozier, Ann; Ford, Dan E.; Harris, Paul; Kim, Emmelyn; Lee, Simon Craddock; O’Riordan, Gerri; Roth, Mary-Tara; Schuff, Kathryn; Wasser, June; Henderson, David K.; Coller, Barry S.

    2014-01-01

    Background Although research participation is essential for clinical investigation, few quantitative outcome measures exist to assess participants’ experiences. To address this, we developed and deployed a survey at 15 NIH-supported clinical research centers to assess participant-centered outcomes; we report responses from 4,961 participants. Methods Survey questions addressed core aspects of the research participants’ experience, including their overall rating, motivation, trust, and informed consent. We describe participant characteristics, responses to individual questions, and correlations among responses. Results Respondents broadly represented the research population in sex, race, and ethnicity. Seventy-three percent awarded top ratings to their overall research experience and 94% reported no pressure to enroll. Top ratings correlated with feeling treated with respect, listened to, and having access to the research team (R2=0.80 - 0.96). White participants trusted researchers (88%) than did non-white participants collectively (80%) (p<0.0001). Many participants felt fully prepared by the informed consent process (67%) and wanted to receive research results (72%). Conclusions Our survey demonstrates that a majority of participants at NIH-supported clinical research centers rate their research experience very positively and that participant-centered outcome measures identify actionable items for improvement of participant’s experiences, research protections, and the conduct of clinical investigation. PMID:24842076

  17. Association between susceptible genotypes to periodontitis and clinical outcomes of periodontal regenerative therapy: A systematic review

    PubMed Central

    Koidou, Vasiliki-Petros

    2016-01-01

    Background The aim of this review is to systematically investigate the effect of a susceptible genotype to periodontitis with the clinical outcomes of periodontal regeneration. Material and Methods Based on a focused question, an electronic search identified 155 unique citations. Three journals (Journal of Periodontology, Journal of Clinical Periodontology and Journal of Periodontal Research), references of relevant studies and review articles were hand-searched. Two independent reviewers implementing eligibility inclusion criteria selected the studies. Results Of the 155, four studies fulfilled the inclusion criteria. All studies were published between 2000 and 2004 and the samples’ size was 40 to 86 patients. Polymorphisms of Interleukin-1 (IL-1) gene were included in all. Three out of four studies failed to identify an association between susceptible genotypes to periodontitis and clinical outcomes of periodontal regeneration, while one found an association. The heterogeneity and small number of studies included prevented the conduct of a meta-analysis. No studies were identified evaluating the effect of other genotypes and as a result only IL-1 genotype studies were included. Conclusions Within the limits of the present review, no direct conclusion for the effect of a susceptible IL-1 genotype status to the clinical outcome after periodontal regeneration could be drawn. The need of more qualitative studies to explore a possible association emerges. Key words:Periodontitis, genotype, periodontal therapy, regeneration, susceptibility, systematic review. PMID:26946210

  18. RD3 loss dictates high-risk aggressive neuroblastoma and poor clinical outcomes

    PubMed Central

    Aravindan, Sheeja; Natarajan, Mohan; Azadi, Seifollah; Herman, Terence S.; Aravindan, Natarajan

    2015-01-01

    Clinical outcomes for high-risk neuroblastoma patients remains poor, with only 40–50% 5-Year overall survival (OS) and <10% long-term survival. The ongoing acquisition of genetic/molecular rearrangements in undifferentiated neural crest cells may endorse neuroblastoma progression. This study recognized the loss of Retinal Degeneration protein 3, RD3 in aggressive neuroblastoma, and identified its influence in better clinical outcomes and defined its novel metastasis suppressor function. The results showed ubiquitous expression of RD3 in healthy tissues, complete-loss and significant TNM-stage association of RD3 in clinical samples. RD3-loss was intrinsically associated with reduced OS, abridged relapse-free survival, aggressive stage etc., in neuroblastoma patient cohorts. RD3 was transcriptionally and translationally regulated in metastatic site-derived aggressive (MSDAC) cells (regardless of CSC status) ex vivo and in tumor manifolds from metastatic sites in reproducible aggressive disease models in vivo. Re-expressing RD3 in MSDACs reverted their metastatic potential both in vitro and in vivo. Conversely muting RD3 in neuroblastoma cells not only heightened invasion/migration but also dictated aggressive disease with metastasis. These results demonstrate the loss of RD3 in high-risk neuroblastoma, its novel, thus-far unrecognized metastasis suppressor function and further imply that RD3-loss may directly relate to tumor aggressiveness and poor clinical outcomes. PMID:26375249

  19. No effect of additional screw fixation of a cementless, all-polyethylene press-fit socket on migration, wear, and clinical outcome.

    PubMed

    Minten, Michiel J M; Heesterbeek, Petra J C; Spruit, Maarten

    2016-08-01

    Background and purpose - Additional screw fixation of the all-polyethylene press-fit RM cup (Mathys) has no additional value for migration, in the first 2 years after surgery. However, the medium-term and long-term effects of screw fixation remain unclear. We therefore evaluated the influence of screw fixation on migration, wear, and clinical outcome at 6.5 years using radiostereometric analysis (RSA). Patients and methods - This study involved prolonged follow-up from a previous randomized controlled trial (RCT). We analyzed RSA radiographs taken at baseline and at 1-, 2-, and 6.5-year follow-up. Cup migration and wear were assessed using model-based RSA software. Wear was calculated as translation of the femoral head model in relation to the cup model. Total translation, rotation, and wear were calculated mathematically from results of the orthogonal components. Results - 27 patients (15 with screw fixation and 12 without) were available for follow-up at 6.5 (5.6-7.2) years. Total translation (0.50 mm vs. 0.56 mm) and rotation (1.01 degrees vs. 1.33 degrees) of the cup was low, and was not significantly different between the 2 groups. Wear increased over time, and was similar between the 2 groups (0.58 mm vs. 0.53 mm). Wear rate (0.08 mm/year vs. 0.09 mm/year) and clinical outcomes were also similar. Interpretation - Our results indicate that additional screw fixation of all-polyethylene press-fit RM cups has no additional value regarding medium-term migration and clinical outcome. The wear rate was low in both groups. PMID:27299418

  20. Correlates of Polysomnographic Sleep Changes in Cocaine Dependence: Self-administration and Clinical Outcomes*

    PubMed Central

    Angarita, Gustavo A.; Canavan, Sofija V.; Forselius, Erica; Bessette, Andrew; Morgan, Peter T.

    2014-01-01

    Background Abstinence from chronic cocaine use is associated with abnormal sleep architecture. As sleep abnormalities are associated with clinical outcome in alcohol dependence, we hypothesized a similar relationship in cocaine dependence. Methods We report data from a cocaine self-administration study (N=12) and the placebo arm of a randomized clinical trial (N=20). Self-administration participants underwent three cocaine self-administration sessions during a three-week inpatient stay. Treatment participants underwent two weeks of inpatient followed by six weeks of outpatient treatment including once-weekly cognitive behavioral therapy. Measurements included polysomnography from early and late in abstinence during the inpatient stays. Clinical outcomes included amount of cocaine self-administered, urine tests, and self-reported use and withdrawal symptoms. Results Change in slow-wave sleep from early to late abstinence (ΔSWS; p=0.05), late abstinence rapid eye movement sleep (REM; p=0.002), and late abstinence total sleep time (p=0.02) were negatively correlated with the amount of cocaine self-administered. Early abstinence REM was positively correlated with withdrawal symptoms (p=0.02). Late abstinence REM was positively correlated with percent negative urines and maximum consecutive number of days abstinent (both p<0.001). ΔSWS was positively correlated with percent negative urines (p=0.03) and participants with increased SWS had greater percent negative urines (p=0.008) and maximum consecutive number of days abstinent (p=0.009). Conclusions Correlations between sleep deficits and amount of cocaine self-administered, clinical outcomes, and severity of withdrawal symptoms underscore the relevance of sleep in clinical outcomes in the treatment of cocaine dependence. PMID:25124303

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

    PubMed Central

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

    2016-01-01

    Objective The use of transcatheter aortic valve implantation (TAVI) is growing rapidly in countries with a predominantly elderly population, posing a huge challenge to healthcare systems worldwide. The increment of human and economic resource consumption imposes a careful monitoring of clinical outcomes and cost-benefit balance, and this article is aimed at analysing clinical outcomes related to the TAVI learning curve. Methods Outcomes of 177 consecutive transfemoral TAVI procedures performed in 5 years by a single team were analysed by the Cumulative Sum of failures method (CUSUM) according to the clinical events comprised in the Valve Academic Research Consortium (VARC-2) safety end point and the VARC-2 definition of device success. Margins for events acceptance were extrapolated from landmark trials that tested both balloon or self-expandable percutaneous valves. Results 30-day and 1-year survival rates were 97.2% and 89.9%, respectively. Achievement of the primary end point (number of cases needed to provide the acceptable margin of the composite end point of any death, stroke, myocardial infarction, life-threatening bleeding, major vascular complications, stage 2–3 acute kidney injury and valve-related dysfunction requiring a repeat procedure) required the performance of 54 cases, while the learning curve to achieve ‘device success’ identified 32 cases to reach the expected proficiency. In this experience, the baseline clinical risk as assessed by the Society of Thoracic Surgeons (STS) score determined the long-term survival rather than the adverse events related to the learning curve. Conclusions A relatively large number of cases are required to achieve clinical outcomes comparable to those reported in high-volume centres and controlled trials. According to our national workload standards, this represents more than 2 years of continuous activity. PMID:27621826

  2. Analyzing Clinical Presentation, Service Utilization, and Clinical Outcome of Female Sexual Minority College Students

    ERIC Educational Resources Information Center

    Kay, Heather C.

    2013-01-01

    Researchers examining clinically-relevant trends for sexual minority women have found evidence of psychological distress and greater utilization of mental health services compared to heterosexually-identified women. However, the results of many research studies with this population have methodological limitations surrounding recruitment of…

  3. Dissociated motor development--developmental patterns, clinical characteristics, causal factors and outcome, with special reference to late walking children.

    PubMed

    Lundberg, A

    1979-05-01

    Dissociated motor development, defined as marked gross motor delay without any abnormal neurological signs and contrasting to a normal fine motor-adaptive performance, was studied prospectively in a consecutive in a consecutive series of 78 children, 48 girls and 30 boys, aged 7-23 months at first examination. When 17 months of age, 10 of them had become normalized, and in further three a disability explaining their gross motor delay had been diagnosed. At an average age of 4.2 years, the remaining 65 late walkers were, regardless of cause and developmental and neurological findings at final follow-up, characterized by a number of deviating clinical features as muscular hypotonia (71%), shuffling (51%) and dissociated or late pattern of learning to sit (79%). In 30 out of 65 late walkers (46%) a defined clinical condition of probable pathogenetic implication was found. In 35 out of 65 late walkers (54%), no explaining clinical condition was found. They have been designed to be idiopathic late walkers. Except for muscular hypotonia, present in 77%, conventional neurology was normal in this group. Minor neurological signs such as a positive Foerster sign, defect balance reactions in standing, or asymmetry in prewalking locomotion were, however, occasionally and temporarily observed. Girls were overrepresented among idiopathic late walkers, 69% compared to 43% among the symptomatic late walkers. Complete normalization was more common in the idiopathic group (66%) than in the symptomatic group (27%). Early differentiation between the late walkers who were normalized and those who developed mild mental retardation or neurological handicaps was difficult but not quite impossible. Heredity for shuffling, a non-revealing pre- and perinatal history, a developmental pattern of late learning to sit, and shuffling favoured a normal outcome. Creepers with a dissociated pattern of learning to sit and crawlers with muscular hypotonia were found to have an increased risk for later

  4. PTA of Infrapopliteal Arteries: Long-term Clinical Follow-up and Analysis of Factors Influencing Clinical Outcome

    SciTech Connect

    Peregrin, Jan H. Koznar, Boris; Kovac, Josef; Lastovickova, Jarmila; Novotny, Jiri; Vedlich, Daniel; Skibova, Jelena

    2010-08-15

    This study was a retrospective analysis of patients with CLI who underwent infrapopliteal percutaneous transluminal angioplasty (PTA). The main goal was to evaluate clinical and morphological factors that influence the clinical outcome of PTA in long-term follow-up. A total of 1,445 PTA procedures were performed in 1,268 patients. Main indications for PTA included gangrene, nonhealing ulcers, or rest pain. The mean number of treated arteries was 1.77 artery/limb, and the majority of lesions were type TASC D. The technical success rate of PTA was 89% of intended-to-treat arteries. The main criterion of clinical success was functional limb salvage (LS). One-year follow-up involved 1,069 limbs. Primary and secondary 1-year LS rates were 76.1 and 84.4%, respectively. The effect of clinical and morphological parameters on the 1-year LS was that the only associated disease with an adverse effect on LS rate was DM combined with dialysis. Regarding limb preprocedural status, gangrene was clearly a negative predictor. The most important factor affecting LS was the number of patent arteries post-PTA: patients with 0, 1, 2, and 3 patent arteries had 1-year primary LS rates of 56.4, 73.1, 80.4, and 83%, respectively. Long-term follow-up of LS rates demonstrated secondary LS rates of 84.4, 78.8, and 73.3% at 1, 5, and 10 years. Every effort should be made to perform PTA for as many arteries as possible, even if TASC D type, to improve clinical outcome. Our study shows that repeat PTA is capable of keeping the long-term LS rate close to 75%.

  5. Naturalistic Outcomes of Evidence-Based Therapies for Borderline Personality Disorder at a Medical University Clinic.

    PubMed

    Gregory, Robert J; Sachdeva, Shilpa

    2016-01-01

    Dialectical behavior therapy (DBT) and dynamic deconstructive psychotherapy (DDP) are listed in the National Registry of Evidence-Based Programs and Practices based on their performances in randomized controlled trials. However, little is known about their effectiveness in real-world settings. In the present study, the authors observed the naturalistic outcomes of 68 clients with borderline personality disorder (BPD) who were treated at a medical university clinic by experienced therapists using either comprehensive DBT (n = 25) or DDP (n = 27), with 16 clients treated with unstructured psychotherapy serving as a control. We found both DBT and DDP achieved significant reductions in symptoms of BPD, depression, and disability by 12 months of treatment, and showed effect sizes consistent with controlled trials. However, attrition from DBT was high and DDP obtained better outcomes than DBT (d = .53). Larger effectiveness studies are needed to replicate these findings, delineate common and unique treatment processes, and determine therapist and patient characteristics predicting positive outcomes. PMID:27329405

  6. Hair mercury concentrations and in vitro fertilization (IVF) outcomes among women from a fertility clinic.

    PubMed

    Wright, Diane L; Afeiche, Myriam C; Ehrlich, Shelley; Smith, Kristen; Williams, Paige L; Chavarro, Jorge E; Batsis, Maria; Toth, Thomas L; Hauser, Russ

    2015-01-01

    Total hair mercury (Hg) was measured among 205 women undergoing in vitro fertilization (IVF) treatment and the association with prospectively collected IVF outcomes (229 IVF cycles) was evaluated. Hair Hg levels (median=0.62ppm, range: 0.03-5.66ppm) correlated with fish intake (r=0.59), and exceeded the recommended EPA reference of 1ppm in 33% of women. Generalized linear mixed models with random intercepts accounting for within-woman correlations across treatment cycles were used to evaluate the association of hair Hg with IVF outcomes adjusted for age, body mass index, race, smoking status, infertility diagnosis, and protocol type. Hair Hg levels were not related to ovarian stimulation outcomes (peak estradiol levels, total and mature oocyte yields) or to fertilization rate, embryo quality, clinical pregnancy rate or live birth rate. PMID:25601638

  7. Hair mercury concentrations and in vitro fertilization (IVF) outcomes among women from a fertility clinic

    PubMed Central

    Ehrlich, Shelley; Smith, Kristen; Williams, Paige L.; Chavarro, Jorge E.; Batsis, Maria; Toth, Thomas L.; Hauser, Russ

    2015-01-01

    Total hair mercury (Hg) was measured among 205 women undergoing in vitro fertilization (IVF) treatment and the association with prospectively collected IVF outcomes (229 IVF cycles) was evaluated. Hair Hg levels (median=0.62 ppm, range: 0.03-5.66 ppm) correlated with fish intake (r=0.59), and exceeded the recommended EPA reference of 1ppm in 33% of women. Generalized linear mixed models with random intercepts accounting for within-woman correlations across treatment cycles were used to evaluate the association of hair Hg with IVF outcomes adjusted for age, body mass index, race, smoking status, infertility diagnosis, and protocol type. Hair Hg levels were not related to ovarian stimulation outcomes (peak estradiol levels, total and mature oocyte yields) or to fertilization rate, embryo quality, clinical pregnancy rate or live birth rate. PMID:25601638

  8. Cardiovascular disease in chronic kidney disease. A clinical update from Kidney Disease: Improving Global Outcomes (KDIGO).

    PubMed

    Herzog, Charles A; Asinger, Richard W; Berger, Alan K; Charytan, David M; Díez, Javier; Hart, Robert G; Eckardt, Kai-Uwe; Kasiske, Bertram L; McCullough, Peter A; Passman, Rod S; DeLoach, Stephanie S; Pun, Patrick H; Ritz, Eberhard

    2011-09-01

    Cardiovascular morbidity and mortality in patients with chronic kidney disease (CKD) is high, and the presence of CKD worsens outcomes of cardiovascular disease (CVD). CKD is associated with specific risk factors. Emerging evidence indicates that the pathology and manifestation of CVD differ in the presence of CKD. During a clinical update conference convened by the Kidney Disease: Improving Global Outcomes (KDIGO), an international group of experts defined the current state of knowledge and the implications for patient care in important topic areas, including coronary artery disease and myocardial infarction, congestive heart failure, cerebrovascular disease, atrial fibrillation, peripheral arterial disease, and sudden cardiac death. Although optimal strategies for prevention, diagnosis, and management of these complications likely should be modified in the presence of CKD, the evidence base for decision making is limited. Trials targeting CVD in patients with CKD have a large potential to improve outcomes. PMID:21750584

  9. Common Minor Histocompatibility Antigen Discovery Based upon Patient Clinical Outcomes and Genomic Data

    PubMed Central

    Armistead, Paul M.; Liang, Shoudan; Li, Hua; Lu, Sijie; Van Bergen, Cornelis A. M.; Alatrash, Gheath; St. John, Lisa; Hunsucker, Sally A.; Sarantopoulos, Stefanie; Falkenburg, J. H. Frederik; Molldrem, Jeffrey J.

    2011-01-01

    Background Minor histocompatibility antigens (mHA) mediate much of the graft vs. leukemia (GvL) effect and graft vs. host disease (GvHD) in patients who undergo allogeneic stem cell transplantation (SCT) [1], [2], [3], [4]. Therapeutic decision making and treatments [5] based upon mHAs will require the evaluation of multiple candidate mHAs and the selection of those with the potential to have the greatest impact on clinical outcomes. We hypothesized that common, immunodominant mHAs, which are presented by HLA-A, B, and C molecules, can mediate clinically significant GvL and/or GvHD, and that these mHAs can be identified through association of genomic data with clinical outcomes. Methodology/Principal Findings Because most mHAs result from donor/recipient cSNP disparities, we genotyped 57 myeloid leukemia patients and their donors at 13,917 cSNPs [6]. We correlated the frequency of genetically predicted mHA disparities with clinical evidence of an immune response and then computationally screened all peptides mapping to the highly associated cSNPs for their ability to bind to HLA molecules. As proof-of-concept, we analyzed one predicted antigen, T4A, whose mHA mismatch trended towards improved overall and disease free survival in our cohort. T4A mHA mismatches occurred at the maximum theoretical frequency for any given SCT. T4A-specific CD8+ T lymphocytes (CTLs) were detected in 3 of 4 evaluable post-transplant patients predicted to have a T4A mismatch. Conclusions/Significance Our method is the first to combine clinical outcomes data with genomics and bioinformatics methods to predict and confirm a mHA. Refinement of this method should enable the discovery of clinically relevant mHAs in the majority of transplant patients and possibly lead to novel immunotherapeutics [5]. PMID:21858034

  10. The National Anesthesia Clinical Outcomes Registry: A Sustainable Model for the Information Age?

    PubMed Central

    Dutton, Richard P.

    2014-01-01

    Anesthesiologists care for patients of all ages, with all conceivable comorbidities, in every kind of health care facility. This leads to a significant challenge in the collection of data to describe the specialty, and in the development of evidence-based performance measures for anesthesiologists. Whereas narrowly defined medical specialties have developed registries based on manual abstraction of clinical data from the medical record (e.g., cardiac surgery), this approach would be prohibitively expensive for anesthesiology, and is unlikely to generate statistically useful data when major adverse outcomes occur a handful of times in tens of thousands of cases. The American Society of Anesthesiologists (ASA) addressed this challenge in 2008 by funding a related organization, the Anesthesia Quality Institute (AQI), to develop the National Anesthesia Clinical Outcomes Registry (NACOR). The technical development of this registry and the approach taken to define the specialty of anesthesiology and the performance of anesthesiologists may serve as a model for other specialty society efforts. PMID:25848607

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

    PubMed

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

    2014-09-01

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

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

    PubMed

    Bond, Bryan M; Kinslow, Christopher

    2015-06-01

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

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

    PubMed Central

    Bond, Bryan M.; Kinslow, Christopher

    2015-01-01

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

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

    PubMed

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

    2007-06-01

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

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

    PubMed

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

    2016-07-01

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

  16. Liver transplantation at the Ochsner Clinic: programmatic expansion and outcomes improvement.

    PubMed

    Carmody, Ian C; Reichman, Trevor W; Bohorquez, Humberto; Cohen, Ari J; Bruce, David S; Therapondos, George; Girgrah, Nigel; Joshi, Shobha; Loss, George E

    2012-01-01

    Liver transplantation has become the best and most durable treatment for both acute and chronic liver disease. Over 1400 liver transplants have been performed at the Ochsner Clinic since the first successful transplant in 1987. Since its inception, the program has gone through several changes and advancements and has become one of the largest liver transplant programs in the United States. We have helped evolve steroid sparing immunosuppression and the use of extended criteria, donor organs. Establishment of criteria for the selection of recipients for re-transplantation has resulted in better than expected short and long-term results. Our center has faced the challenge of Hurricane Katrina and overcome it. We have improved steadily in both outcomes and transplants performed. The Ochnser Clinic Liver Transplant program will continue to improve access and outcomes for all patients with liver disease. PMID:23721014

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

    PubMed

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

    2016-07-01

    Idiopathic normal pressure hydrocephalus (INPH) is a syndrome of gait disturbance, dementia and urinary incontinence. Outcomes after ventriculoperitoneal shunting for INPH are variable due to a lack of reliable, quantitative outcome data and inconsistent methods of selecting shunt candidates. The aim of this retrospective cohort study was to assess objective and quantitative clinical outcomes of ventriculoperitoneal shunting for INPH. From 2008 to 2013, consecutive patients diagnosed with INPH based on clinical and radiological criteria were included in this single-centre study. All patients received programmable-valve ventriculoperitoneal shunts. Outcome measures were assessed at baseline, 3, 6 and 12months post-operatively. Outcomes included gait time and scores on the Unified Parkinson's Disease Rating Scale part III (UPDRS-III), the Addenbrooke's Cognitive Examination Revised (ACE-R) and the Mini-Mental State Examination (MMSE). Thresholds for improvements were set a priori as ⩾20% decrease in gait time, ⩾10point decrease in UPDRS-III score, ⩾5point increase in ACE-R score and ⩾2point increase in MMSE score at last follow-up. The proportion of patients improving varied between measures, being gait time (60%), UPDRS-III (69%), MMSE (63%), and ACE-R (56%). Overall, improvement in at least one outcome measure was observed in 85% of patients and 38% improved in gait time, UPDRS-III score and cognitive scores. Only 15% of patients experienced no improvement on any measure. This study demonstrates that the majority of INPH patients can sustain improvements in multiple symptoms up to 12months after shunting. PMID:26935749

  18. Preoperative angiotensin converting enzyme inhibitor usage in patients with chronic subdural hematoma: Associations with initial presentation and clinical outcome.

    PubMed

    Neidert, Marian C; Schmidt, Tobias; Mitova, Tatyana; Fierstra, Jorn; Bellut, David; Regli, Luca; Burkhardt, Jan-Karl; Bozinov, Oliver

    2016-06-01

    The aim of this study is to analyze the association of preoperative usage of angiotensin converting enzyme (ACE) inhibitors with the initial presentation and clinical outcome of patients with chronic subdural hematoma (cSDH). Patients treated for cSDH between 2009 and 2013 at our institution were included in this retrospective case-control study. Medical charts were reviewed retrospectively and data were analyzed using descriptive and inferential statistics. Out of 203 patients (58 females, mean age 73.2years), 53 (26%) patients were on ACE inhibitors before their presentation with cSDH. Median initial hematoma volume in individuals with ACE inhibitors (179.2±standard error of the mean [SEM] 13.0ml) was significantly higher compared to patients without ACE inhibitors (140.4±SEM 6.2ml; p=0.007). There was an increased probability of surgical reintervention in the ACE inhibitor group (12/53, 23% versus 19/153, 12%; p=0.079), especially in patients older than 80years (6/23, 26% versus 3/45, 7%; p=0.026). ACE inhibitors are associated with higher hematoma volume in patients with cSDH and with a higher frequency of recurrences requiring surgery (especially in the very old). We hypothesize that these effects are due to ACE inhibitor induced bradykinin elevation causing increased vascular permeability of the highly vascularized neomembranes in cSDH. PMID:26898577

  19. Biological, physical factors in clinical assessment of outcome of cancer therapy.

    PubMed

    Perez, Carlos A

    2005-01-01

    Complex molecular and cellular biological phenomena influence the response of tumor and normal cell to cytotoxic agents, including irradiation. Innovative 3-D treatment planning and IGRT techniques allow more quantitative optmization of irradiation dose distribution in target volumes and OAR. More detailed reporting on radiation doses is required with incorporation of biological parameters in treatment planning and dose specification. TCP and NTCP models should be validate with actual clinical data. Quality assurance in radiation oncology is mandatory. Because of increasing concerns with health care costs, technology assessment and cost benefit studies should be an integral component of clinical outcome reporting. PMID:16294900

  20. Clinical Outcome of Dose-Escalated Image-Guided Radiotherapy for Spinal Metastases

    SciTech Connect

    Guckenberger, Matthias; Goebel, Joachim; Wilbert, Juergen; Baier, Kurt; Richter, Anne; Sweeney, Reinhart A.; Bratengeier, Klaus; Flentje, Michael

    2009-11-01

    Purpose: To evaluate the outcomes after dose-escalated radiotherapy (RT) for spinal metastases and paraspinal tumors. Methods and Materials: A total of 14 patients, 12 with spinal metastases and a long life expectancy and 2 with paraspinal tumors, were treated for 16 lesions with intensity-modulated, image-guided RT. A median biologic effective dose of 74 Gy{sub 10} (range, 55-86) in a median of 20 fractions (range, 3-34) was prescribed to the target volume. The spinal canal was treated to 40 Gy in 20 fractions using a second intensity-modulated RT dose level in the case of epidural involvement. Results: After median follow-up of 17 months, one local recurrence was observed, for an actuarial local control rate of 88% after 2 years. Local control was associated with rapid and long-term pain relief. Of 11 patients treated for a solitary spinal metastasis, 6 developed systemic disease progression. The actuarial overall survival rate for metastatic patients was 85% and 63% after 1 and 2 years, respectively. Acute Grade 2-3 skin toxicity was seen in 2 patients with no late toxicity greater than Grade 2. No radiation-induced myelopathy was observed. Conclusion: Dose-escalated irradiation of spinal metastases was safe and resulted in excellent local control. Oligometastatic patients with a long life expectancy and epidural involvement are considered to benefit the most from fractionated RT.

  1. Clinical, Biochemical and Outcome Profile of Biotinidase Deficient Patients from Tertiary Centre in Northern India

    PubMed Central

    Singh, Ankur; Lomash, Avinash; Pandey, Sanjeev

    2015-01-01

    Introduction Biotinidase deficiency is an inherited metabolic disorder with estimated birth incidence of 1 in 61,000 for profound and partial deficiency. Estimated incidence of profound and partial biotinidase deficiency is 1 in 1, 37,000 and 1 in 1, 10,000 respectively. The carrier frequency in general population is 1 in 120. We attempt to study clinical, biochemical and outcome from 10 Biotinidase deficient patients. Materials and Methods A retrospective case record study was conducted to record Clinical, biochemical and outcome profile from genetic records. Biotinidase level was measured using spectrophotometric method. Results Study group comprised of 8 males and 2 females with median age of presentation 6 (2-45.75) months. Median (interquartile range) Biotinidase level in study group 0.3 (0.08—1.5) nmol/ml/min. Study group was further divided in to early onset group (< 12 months, n-6) and late onset group (> 12 months, n-4). Seizure, alopecia and hearing loss were predominant phenotypes in study group. The other rare presentations were: hypotonia, ataxia, skin rash, seborrhoea. The most common seizure type was focal seizure. Control of seizure activity was important immediate outcome measured in study group. Median duration (interquartile range) of seizure control in early onset group was 3 (2-4)days against 13.5 (12.25-14.75) days in late onset group. Conclusion This study highlights the need of early diagnosis for favourable outcome for a potentially treatable inherited metabolic disorder. PMID:26816961

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

    PubMed

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

    2014-03-01

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

  3. Clinical and radiographic parameters associated with best versus worst clinical outcomes in minimally invasive spinal deformity surgery.

    PubMed

    Than, Khoi D; Park, Paul; Fu, Kai-Ming; Nguyen, Stacie; Wang, Michael Y; Chou, Dean; Nunley, Pierce D; Anand, Neel; Fessler, Richard G; Shaffrey, Christopher I; Bess, Shay; Akbarnia, Behrooz A; Deviren, Vedat; Uribe, Juan S; La Marca, Frank; Kanter, Adam S; Okonkwo, David O; Mundis, Gregory M; Mummaneni, Praveen V

    2016-07-01

    OBJECTIVE Minimally invasive surgery (MIS) techniques are increasingly used to treat adult spinal deformity. However, standard minimally invasive spinal deformity techniques have a more limited ability to restore sagittal balance and match the pelvic incidence-lumbar lordosis (PI-LL) than traditional open surgery. This study sought to compare "best" versus "worst" outcomes of MIS to identify variables that may predispose patients to postoperative success. METHODS A retrospective review of minimally invasive spinal deformity surgery cases was performed to identify parameters in the 20% of patients who had the greatest improvement in Oswestry Disability Index (ODI) scores versus those in the 20% of patients who had the least improvement in ODI scores at 2 years' follow-up. RESULTS One hundred four patients met the inclusion criteria, and the top 20% of patients in terms of ODI improvement at 2 years (best group, 22 patients) were compared with the bottom 20% (worst group, 21 patients). There were no statistically significant differences in age, body mass index, pre- and postoperative Cobb angles, pelvic tilt, pelvic incidence, levels fused, operating room time, and blood loss between the best and worst groups. However, the mean preoperative ODI score was significantly higher (worse disability) at baseline in the group that had the greatest improvement in ODI score (58.2 vs 39.7, p < 0.001). There was no difference in preoperative PI-LL mismatch (12.8° best vs 19.5° worst, p = 0.298). The best group had significantly less postoperative sagittal vertical axis (SVA; 3.4 vs 6.9 cm, p = 0.043) and postoperative PI-LL mismatch (10.4° vs 19.4°, p = 0.027) than the worst group. The best group also had better postoperative visual analog scale back and leg pain scores (p = 0.001 and p = 0.046, respectively). CONCLUSIONS The authors recommend that spinal deformity surgeons using MIS techniques focus on correcting a patient's PI-LL mismatch to within 10° and restoring SVA

  4. The Association of Diabetes Mellitus with Clinical Outcomes after Coronary Stenting: A Meta-Analysis

    PubMed Central

    Jiang, Hai-Xing; Hu, Bang-Li; Tao, Lin; Xie, Min-zhi

    2013-01-01

    Background Previous studies have shown inconsistent results on the association between diabetes mellitus (DM) and some clinical outcomes. We conducted a meta-analysis of observational studies to assess effect of DM on clinical outcomes after coronary stenting. Methods We searched for studies without language restriction in PubMed, Embase and Cochrane library prior to 2012. The clinical outcomes including in-stent restenosis (ISR), major adverse cardiac events (MACE), stent thrombosis (ST), target lesion revascularization (TLR) and target vessel revascularization (TVR). Adjusted odds ratio (OR), and the corresponding 95% confidence interval (95% CI) was summarized. Results 55 studies involving 128,084 total patients (38,416 DM patients and 89,668 controls) were eligible for our analysis. Overall, there were significant associations between DM and ISR (OR = 1.70, 95% CI: 1.53–1.89, I2 = 0.0%), MACE (OR = 1.54, 95% CI: 1.36–1.73, I2 = 29.0%), ST (OR = 2.01, 95% CI: 1.36–2.97, I2 = 47.7%), TLR (OR = 1.46, 95% CI: 1.26–1.68, I2 = 43.3%) as well as TVR (OR = 1.33, 95% CI: 1.17–1.51, I2 = 48.3). Subgroup analysis showed that the associations were similar between BMS and DES implantation. Moreover, there was no significant association in the ST subgroup after 1–3 years follow-up. Conclusions Our meta-analysis suggests that after coronary stent implantation, DM is associated with ISR, MACE, ST, TLR and TVR. DM appears to be a vital risk factor of these clinical outcomes. PMID:24066025

  5. Cryptococcemia. An analysis of 28 cases with emphasis on the clinical outcome and its etiologic agent.

    PubMed

    Pasqualotto, Alessandro Comarú; Bittencourt Severo, Cecília; de Mattos Oliveira, Flávio; Severo, Luiz Carlos

    2004-09-01

    Clinical protocols of 28 cases of cryptococcemia studied between April 1995 and November 2002 were reviewed. The varieties of Cryptococcus neorformans, the underlying disease, and the severity and outcome of the disease were emphasized. Most patients were immunossupressed (89.3% with AIDS) and Cryptococcus neoformans var. grubii was the main recovered variety (92.8%). Regardless of antifungal treatment, in-hospital mortality was 41% strongly associated with APACHE II score, >14 (p<0.01). PMID:15709789

  6. Is there a relationship between admission blood glucose level following acute poisoning and clinical outcome?

    PubMed Central

    Sabzghabaee, Ali Mohammad; Eizadi-Mood, Nastaran; Gheshlaghi, Farzad; Adib, Nooshin; Safaeian, Leila

    2011-01-01

    Introduction The aim of this study was to investigate the relationship between the admission blood glucose level following acute poisoning, severity of acute poisoning and clinical outcome. Material and methods This prospective study was conducted on 345 deliberate self-poisoning patients. Standard demographic and clinical information; admission blood glucose level; poisoning severity score and outcome were recorded. Patients with a history of diabetes mellitus, receipt of pre-sampling intravenous dextrose solution or glucocorticoids, and poisoning with toxic agents which produce hyper- or hypoglycaemia were excluded. Results Mean age of the patients was 27.5 ±8.6 years. Females outnumbered males (57.9%). Oral ingestion of more than one drug (46.7%) and opiates (14.2%) were the main causes of poisoning. Blood glucose values ranged from 50 mg/dl to 396 mg/dl. Hyper- and hypoglycaemia were observed in 23.8% and 13.91% respectively. A total of 24.41% and 22.92% of the patients in hyper- and hypoglycaemic groups had grade 3 and 4 severity score in comparison with 4.18% in the normoglycaemic group. Development of complications and death were 14.64% and 10.42% in patients with hyper- and hypoglycaemia versus 3.73% in patients with normoglycaemia. A significant difference between normoglycaemic and hyperglycaemic patients in the severity of poisoning and clinical outcome was observed (P < 0.001). Conclusions Admission blood glucose levels may have a relationship with the severity of poisoning and clinical outcome following acute poisoning. PMID:22291737

  7. Clinical Characteristics and Outcome in Dogs with Splenic Marginal Zone Lymphoma

    PubMed Central

    O’Brien, D.; Moore, P.F.; Vernau, W.; Peauroi, J.R.; Rebhun, R.B.; Rodriguez, C.O.; Skorupski, K.A.

    2016-01-01

    Background Splenic marginal zone lymphoma (MZL) is a form of indolent B-cell lymphoma that is not well characterized in dogs. Hypothesis/Objectives The purpose of this study was to describe clinical characteristics and outcome in dogs with splenic MZL confirmed by histopathology, immunophenotyping, and molecular clonality assessment. We hypothesized that affected dogs would have prolonged survival time with splenectomy alone. Animals Thirty-four dogs were included. Twenty-nine dogs were diagnosed after splenectomy, and 5 dogs were diagnosed at necropsy. Methods Pathology records were searched for dogs with histologically confirmed splenic MZL. Clinical and outcome data were retrospectively collected by medical record review, and prognostic factors were evaluated. Histopathology was reviewed by a board-certified pathologist, and tissue sections were subjected to immunophenotyping and molecular clonality assessment by PCR. Results Immunohistochemistry confirmed a B-cell phenotype for all dogs. Molecular clonality assessment was performed in 33 of 34 dogs, of which 24 had clonal rearrangement of immunoglobulin (Ig) loci, 3 had pseudoclonal rearrangement, and 6 had polyclonal rearrangement. The overall median survival time (MST) for the 29 dogs that underwent splenectomy was 383 days. The MST for 14 of 29 asymptomatic dogs that underwent splenectomy for MZL was 1,153 days as compared to 309 days for 15/29 dogs with clinical signs referable to splenic MZL (P = .018). Lymph node involvement, hemoabdomen, anemia, chemotherapy, and concurrent malignancy did not affect survival outcome. Conclusions and Clinical Importance Dogs diagnosed with splenic MZL can have prolonged survival with splenectomy alone, without the use of adjuvant chemotherapy. Asymptomatic dogs may have a better survival outcome. PMID:23734665

  8. Electrical impedance myography to assess outcome in amyotrophic lateral sclerosis clinical trials

    PubMed Central

    Rutkove, Seward B.; Zhang, Hui; Schoenfeld, David A.; Raynor, Elizabeth M.; Shefner, Jeremy M.; Cudkowicz, Merit E.; Chin, Anne B.; Aaron, Ronald; Shiffman, Carl A.

    2007-01-01

    Objective Standard outcome measures used for amyotrophic lateral sclerosis (ALS) clinical trials, including the ALS Functional Rating Scale-revised (ALSFRS-R), maximal voluntary isometric contraction testing (MVICT), and manual muscle testing (MMT) are limited in their ability to detect subtle disease progression. Electrical impedance myography (EIM) is a new non-invasive technique that provides quantitative data on muscle health by measuring localized tissue impedance. This study investigates whether EIM could provide a new outcome measure for use in ALS clinical trials work. Methods Fifteen ALS patients underwent repeated EIM measurements of one or more muscles over a period of up to 18 months and the primary outcome variable, θz-max, measured. The θz-max megascore was then calculated using the same approach as has been applied in the past for MVICT. This and the MMT data were then used to assess each measure’s statistical power to detect a given effect on disease progression in a hypothetical planned clinical therapeutic trial. Results θz-max showed a mean decline of about 21% for the test period, averaged across all patients and all tested muscles. The θz-max megascore had a power of 73% to detect a 10% treatment effect in our planned hypothetical trial, as compared to a 28% power for MMT. These results also compared favorably to historical data for ALSFRS-R and MVICT arm megascore from the trial of celecoxib in ALS, where both measures had only a 23% power to detect the same 10% treatment effect. Conclusions The θz-max megascore may provide a powerful new outcome measure for ALS clinical trials. Significance The application of EIM to future ALS trials may allow for smaller, faster studies with an improved ability to detect subtle treatment effects. PMID:17897874

  9. Toric intraocular lenses: historical overview, patient selection, IOL calculation, surgical techniques, clinical outcomes, and complications.

    PubMed

    Visser, Nienke; Bauer, Noël J C; Nuijts, Rudy M M A

    2013-04-01

    We present an overview of currently available toric intraocular lenses (IOLs) and multifocal toric IOLs. Relevant patient selection criteria, IOL calculation issues, and surgical techniques for IOL implantation are discussed. Clinical outcomes including uncorrected visual acuity, residual refractive astigmatism, and spectacle independency, which have been reported for both toric IOLs and multifocal toric IOLs, are reviewed. The incidence of misalignment, the most important complication of toric IOLs, is determined. Finally, future developments in the field of toric IOLs are discussed. PMID:23522584

  10. The influence of graft placement on clinical outcome in anterior cruciate ligament reconstruction

    PubMed Central

    PADUA, ROBERTO; ALVITI, FEDERICA; VENOSA, MICHELE; MAZZOLA, CARLO; PADUA, LUCA

    2016-01-01

    Purpose the aim of the present study was to investigate the influence of graft tunnel position on both clinical outcome and instrumental knee stability in patients submitted to arthroscopic ACL reconstruction using a bone-patellar tendon-bone (BPTB) graft. Methods thirty patients (24 men and 6 women) who underwent ACL reconstruction performed using an autologous bone-patellar tendon-bone graft were studied at a mean follow-up of 18 months. Clinical outcome was assessed on the basis of the Lysholm score, Tegner activity level, International Knee Documentation Committee (IKDC) subjective form and the Short Form-36. Clinical outcomes were correlated with both femoral and tibial tunnel placement measured on standard anteroposterior and lateral knee radiographs, in accordance with established guidelines. Results tibial tunnel position on the lateral view correlated significantly with both the IKDC subjective form (r = −0.72; p<0.05) and the Lysholm score (r=−0.73; p<0.05). Tibial tunnel position on the lateral view also correlated with stability measured using a KT-1000 arthrometer at 30N of force (r=0.57; p<0.05). No correlation was found between α angle and anteroposterior (AP) laxity measured by KT-1000 arthrometer. No significant correlation was found between femoral tunnel position (on either view) and Lysholm score, IKDC score and Tegner activity level. Similarly, no correlation was found between AP laxity measured by KT-1000 arthrometer and femoral tunnel position. Conclusions these results suggest that the more anterior the placement of the tibial tunnel, the better the clinical outcome will be. On the basis of literature data and our findings, we discuss the hypothesis that there exists a “correct area” for tunnel placement, making it possible to obtain the best results. Level of evidence Level IV, case series. PMID:27386442

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

    PubMed Central

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

    2016-01-01

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

  12. Prediction of Functional Outcome in Individuals at Clinical High Risk for Psychosis

    PubMed Central

    Carrión, Ricardo E.; McLaughlin, Danielle; Goldberg, Terry E.; Auther, Andrea M.; Olsen, Ruth H.; Olvet, Doreen M.; Correll, Christoph U.; Cornblatt, Barbara A.

    2014-01-01

    Importance A major public health concern associated with schizophrenia and psychotic disorders is the long-term disability that involves impaired cognition, lack of social support, and an inability to function independently in the community. A critical goal of early detection and intervention studies in psychosis is therefore to understand the factors leading to this often profound impairment. Objective To develop a predictive model of functional (social and role) outcome in a clinical high-risk sample for psychosis. Design Prospective, naturalistic, longitudinal 3- to 5-year follow-up study. Setting The Recognition and Prevention Program in New York, a research clinic located in the Zucker Hillside Hospital in New York. Participants One hundred one treatment-seeking patients at clinical high risk for psychosis. Ninety-two (91%) were followed up prospectively for a mean (SD) of 3 (1.6) years. Intervention Neurocognitive and clinical assessment. Main Outcomes and Measures The primary outcome variables were social and role functioning at the last follow-up visit. Results Poor social outcome was predicted by reduced processing speed (odds ratio [OR], 1.38; 95% CI, 1.050-1.823; P = .02), impaired social functioning at baseline (OR, 1.85; 95% CI, 1.258-2.732; P = .002), and total disorganized symptoms (OR, 5.06; 95% CI, 1.548-16.527; P = .007). Reduced performance on tests for verbal memory (OR, 1.74; 95% CI, 1.169-2.594; P = .006), role functioning at baseline (OR, 1.34; 95% CI, 1.053-1.711; P = .02), and motor disturbances (OR, 1.77; 95% CI, 1.060-2.969; P = .03) predicted role outcome. The areas under the curve for the social and role prediction models were 0.824 (95% CI, 0.736-0.913; P < .001) and 0.77 (95% CI, 0.68-0.87; P < .001), respectively, demonstrating a high discriminative ability. In addition, poor functional outcomes were not entirely dependent on the development of psychosis, because 40.3% and 45.5% of nonconverters at clinical high risk had poor social

  13. Effect of Family History on Outcomes in Patients Treated With Definitive Brachytherapy for Clinically Localized Prostate Cancer

    SciTech Connect

    Peters, Christopher A. Stock, Richard G.; Blacksburg, Seth R.; Stone, Nelson N.

    2009-01-01

    Purpose: To determine the impact familial prostate cancer has on prognosis in men treated with brachytherapy for clinically localized prostate cancer. Methods and Materials: A total of 1,738 consecutive patients with prostate cancer (cT1-3, N0/X, M0) received low-dose-rate brachytherapy alone or in combination with external beam radiation therapy or hormone ablation from 1992 to 2005. The primary end-point was freedom from biochemical failure (FFBF) using the Phoenix definition. Minimum follow-up was 2 years and the median follow-up was 60 months (range, 24-197 months). Results: A total of 187 of 1,738 men (11%) had a family history of prostate cancer in a first-degree relative. For the low-risk patients, both groups had similar actuarial 5-year FFBF (97.2% vs. 95.5%, p = 0.516). For intermediate-risk patients, there was a trend toward improved biochemical control in men positive for family history (5-yr FFBF 100% vs. 93.6%, p = 0.076). For the high-risk patients, men with a positive family history had similar 5-year FFBF (92.8% vs. 85.2%, p = 0.124). On multivariate analysis, family history was not significant; use of hormones, high biologic effective dose, initial prostate-specific antigen value, and Gleason score were the significant variables predicting biochemical control. Conclusions: This is the first study to examine the relationship of familial prostate cancer and outcomed in men treated with brachytherapy alone or in combination therapy. Men with a positive family history have clinicopathologic characteristics and biochemical outcomes similar to those with sporadic disease.

  14. The EMPA-REG outcome study: critical appraisal and potential clinical implications.

    PubMed

    Perseghin, Gianluca; Solini, Anna

    2016-01-01

    Diabetes health care professionals have to face a study with results of incomparable success in secondary and tertiary cardiovascular disease prevention. In the past, no studies in patients with type 2 diabetes resulted to be successful in inducing an improvement of cardiovascular prognosis, no matter whether they were focused on a target, on life-style or on pharmacological intervention. On a clinical perspective, should the diabetologist's way to think about the anti-diabetic therapy of patients on secondary cardiovascular prevention change based on the results of Empa-Reg outcome? Due to the complexity of the clinical picture of patients with type 2 diabetes, a tailored therapy based on targets, complications, co-morbidity, familial and social environment, personal and cultural features must be conceived and applied in starting pharmacological therapy; however, the question whether should we consider empagliflozin as first choice therapy in individuals with type 2 diabetes exposed to high cardiovascular risk, the Empa-Reg outcome-like patient, awaits now for an answer. Waiting for data confirming the results of the Empa-Reg outcome study, this report goes through the good reasons in support of this way of thinking, but at the same time explores the many unanswered questions raising potential concerns about this clinical choice. PMID:27260022

  15. Clinical outcomes of splenectomy in children: report of the splenectomy in congenital hemolytic anemia registry.

    PubMed

    Rice, Henry E; Englum, Brian R; Rothman, Jennifer; Leonard, Sarah; Reiter, Audra; Thornburg, Courtney; Brindle, Mary; Wright, Nicola; Heeney, Matthew M; Smithers, Charles; Brown, Rebeccah L; Kalfa, Theodosia; Langer, Jacob C; Cada, Michaela; Oldham, Keith T; Scott, J Paul; St Peter, Shawn; Sharma, Mukta; Davidoff, Andrew M; Nottage, Kerri; Bernabe, Kathryn; Wilson, David B; Dutta, Sanjeev; Glader, Bertil; Crary, Shelley E; Dassinger, Melvin S; Dunbar, Levette; Islam, Saleem; Kumar, Manjusha; Rescorla, Fred; Bruch, Steve; Campbell, Andrew; Austin, Mary; Sidonio, Robert; Blakely, Martin L

    2015-03-01

    The outcomes of children with congenital hemolytic anemia (CHA) undergoing total splenectomy (TS) or partial splenectomy (PS) remain unclear. In this study, we collected data from 100 children with CHA who underwent TS or PS from 2005 to 2013 at 16 sites in the Splenectomy in Congenital Hemolytic Anemia (SICHA) consortium using a patient registry. We analyzed demographics and baseline clinical status, operative details, and outcomes at 4, 24, and 52 weeks after surgery. Results were summarized as hematologic outcomes, short-term adverse events (AEs) (≤30 days after surgery), and long-term AEs (31-365 days after surgery). For children with hereditary spherocytosis, after surgery there was an increase in hemoglobin (baseline 10.1 ± 1.8 g/dl, 52 week 12.8 ± 1.6 g/dl; mean ± SD), decrease in reticulocyte and bilirubin as well as control of symptoms. Children with sickle cell disease had control of clinical symptoms after surgery, but had no change in hematologic parameters. There was an 11% rate of short-term AEs and 11% rate of long-term AEs. As we accumulate more subjects and longer follow-up, use of a patient registry should enhance our capacity for clinical trials and engage all stakeholders in the decision-making process. PMID:25382665

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

    PubMed Central

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

    2015-01-01

    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. PMID:26405592

  17. Comparison of clinical outcomes between ABO-compatible and ABO-incompatible spousal donor kidney transplantation

    PubMed Central

    Park, Woo Yeong; Kang, Seong Sik; Park, Sung Bae; Park, Ui Jun; Kim, Hyong Tae; Cho, Won Hyun; Han, Seungyeup

    2016-01-01

    Background Kidney transplantation (KT) is the treatment of choice for end-stage renal disease patients. The spouse is a major donor in living KT. Clinical outcomes of spousal donor KT are not inferior to those of living related donor KT. In this study, we compared clinical outcomes between ABO-compatible (ABOc) and ABO-incompatible (ABOi) spousal donor KTs. Methods Thirty-two cases of spousal donor KT performed from January 2011 to August 2013 were analyzed retrospectively. Twenty-one ABOc KTs and 11 ABOi KTs were performed. We investigated patient survival, graft survival, acute rejection, graft function, and complications. Results During follow-up, patient and graft survival rates were 100% in both groups. There were no significant differences in the incidence of delayed graft function, acute rejection, and the change in graft function between the 2 groups. Medical and surgical complications were not significantly different between the groups. Conclusion The clinical outcomes of ABOc and ABOi spousal donor KTs were equivalent. In ABOi KT, an emotionally motivated spousal donor KT may be a good alternative to the problem of the absolute shortage of kidney donations. PMID:27069858

  18. Cell-seeded Autologous Chondrocyte Implantation (cs-ACI) - A Simplified Implantation Technique with Maintained Clinical Outcomes

    PubMed Central

    Ambra, Luiz Felipe Morlin; Phan, Amy; Mastrocola, Marissa; Gomoll, Andreas H.

    2016-01-01

    . Significant improvements were seen in all scores except Tegner from the pre-operative baseline to the latest follow-up for both groups; however, no significant difference was found between groups at the latest follow-up. Failure rate at 2 years was not significantly different, while total failure rate over the entire study period was significantly lower in the cell-seeded group (cs-ACI) (5% versus 24%). The difference in Kaplan-Meier survivorship (Figure 1) failed to reach significance. Conclusion: Both ACI techniques demonstrated statistically significant and clinically meaningful improvements in patient reported outcomes that were not different between groups. Follow-up time was shorter in the cell-seeded technique, as patients in this group were treated more recently. The absolute failure rate was significantly lower in the simplified, cell-seeded technique with 5% versus 24% with the traditional technique. However, this should be interpreted in context of the shorter follow-up time and smaller defect size in the cell-seeded group, both favoring a lower failure rate. Overall, this study demonstrated that a simplified ACI technique maintained the same patient reported outcomes of a more complicated traditional technique without increases in failure.

  19. Correlation of AOL Recanalization, TIMI Reperfusion and TICI Reperfusion with Infarct Growth and Clinical Outcome

    PubMed Central

    Marks, Michael P.; Lansberg, Maarten G.; Mlynash, Michael; Kemp, Stephanie; McTaggart, Ryan; Zaharchuk, Greg; Bammer, Roland; Albers, Gregory W.

    2014-01-01

    Objective To understand how three commonly utilized measures of endovascular therapy correlate with clinical outcome and infarct growth. Methods Prospectively enrolled patients underwent baseline MRI and started endovascular therapy within 12 hours of stroke onset. The final angio was given a recanalization score of the primary arterial occlusive lesion- AOL (0-3), a Thrombolysis in Myocardial Infarct (TIMI) Score (0-3) and a Thrombolysis in Cerebral Infarction (TICI) Score (0-3). Scores were dichotomized into poor revascularization (AOL 0-2, TIMI 0-1 and TICI 0-2a) versus good (AOL 3, TIMI 2-3, TICI 2b-3). Patients were classified as Target Mismatch (TMM) or no TMM. Good outcome was a 90 day mRS of 0-2. Results 100 patients had attempted endovascular treatment. TICI 2B-3 patients had 57% good outcome compared to 24% of TICI 0-2A patients (p=0.001). TIMI 2-3 patients and AOL 3 patients had lower rates of good outcome (44% and 47% respectively) which were not significantly better than TIMI 0-1 or AOL 0-2. In the TMM patients these rates of good outcome improved with all scoring systems and were significantly better for TIMI and TICI scores. TICI 2A patients had rates of GFO and lesion growth which were not different then TICI 0-1 patients but significantly worse than TICI 2B-3 patients. Conclusion TIMI 2-3 and TICI 2B-3 reperfusion scores demonstrated improved outcome in mismatch patients with small infarct core and a larger hypoperfused region. AOL scores did not. TICI 2A patients had poorer outcome and more lesion growth than TICI 2B-3 patients. PMID:24353330

  20. Clinical outcomes of locked plating of distal femoral fractures in a retrospective cohort

    PubMed Central

    2013-01-01

    Purpose Locked plating (LP) of distal femoral fractures has become very popular. Despite technique suggestions from anecdotal and some early reports, knowledge about risk factors for failure, nonunion (NU), and revision is limited. The purpose of this study was to analyze the complications and clinical outcomes of LP treatment for distal femoral fractures. Materials and methods From two trauma centers, 243 consecutive surgically treated distal femoral fractures (AO/OTA 33) were retrospectively identified. Of these, 111 fractures in 106 patients (53.8% female) underwent locked plate fixation. They had an average age of 54 years (range 18 to 95 years): 34.2% were obese, 18.9% were smokers, and 18.9% were diabetic. Open fractures were present in 40.5% with 79.5% Gustilo type III. Fixation constructs for plate length, working length, and screw concentration were delineated. Nonunion and/or infection, and implant failure were used as outcome complication variables. Outcome was based on surgical method and addressed according to Pritchett for reduction, range of motion, and pain. Results Eighty-three (74.8%) of the fractures healed after the index procedure. Twenty (18.0%) of the patients developed a NU. Four of 20 (20%) resulted in a recalcitrant NU. Length of comminution did not correlate to NU (p = 0.180). Closed injuries had a higher tendency to heal after the index procedure than open injuries (p = 0.057). Closed and minimally open (Gustilo/Anderson types I and II) fractures healed at a significantly higher rate after the index procedure compared to type III open fractures (80.0% versus 61.3%, p = 0.041). Eleven fractures (9.9%) developed hardware failure. Fewer nonunions were found in the submuscular group (10.7%) compared to open reduction (32.0%) (p = 0.023). Fractures above total knee arthroplasties had a significantly greater rate of failed hardware (p = 0.040) and worse clinical outcome according to Pritchett (p = 0.040). Loss of

  1. Depressive Symptoms, Anatomical Region, and Clinical Outcomes for Patients Seeking Outpatient Physical Therapy for Musculoskeletal Pain

    PubMed Central

    Coronado, Rogelio A.; Beneciuk, Jason M.; Valencia, Carolina; Werneke, Mark W.; Hart, Dennis L.

    2011-01-01

    Background Clinical guidelines advocate the routine identification of depressive symptoms for patients with pain in the lumbar or cervical spine, but not for other anatomical regions. Objective The purpose of this study was to investigate the prevalence and impact of depressive symptoms for patients with musculoskeletal pain across different anatomical regions. Design This was a prospective, associational study. Methods Demographic, clinical, depressive symptom (Symptom Checklist 90–Revised), and outcome data were collected by self-report from a convenience sample of 8,304 patients. Frequency of severe depressive symptoms was assessed by chi-square analysis for demographic and clinical variables. An analysis of variance examined the influence of depressive symptoms and anatomical region on intake pain intensity and functional status. Separate hierarchical multiple regression models by anatomical region examined the influence of depressive symptoms on clinical outcomes. Results Prevalence of severe depression was higher in women, in industrial and pain clinics, and in patients who reported chronic pain or prior surgery. Lower prevalence rates were found in patients older than 65 years and those who had upper- or lower-extremity pain. Depressive symptoms had a moderate to large effect on pain ratings (Cohen d=0.55–0.87) and a small to large effect on functional status (Cohen d=0.28–0.95). In multivariate analysis, depressive symptoms contributed additional variance to pain intensity and functional status for all anatomical locations, except for discharge values for the cervical region. Conclusions Rates of depressive symptoms varied slightly based on anatomical region of musculoskeletal pain. Depressive symptoms had a consistent detrimental influence on outcomes, except on discharge scores for the cervical anatomical region. Expanding screening recommendations for depressive symptoms to include more anatomical regions may be indicated in physical therapy

  2. Clinical characteristics and outcome of Penicillium marneffei infection among HIV-infected patients in northern Vietnam

    PubMed Central

    2012-01-01

    Objective This study reports the clinical characteristics and outcome of HIV-associated Penicilliummarneffei infection in northern Vietnam. Methods We conducted a retrospective chart review of all patients with laboratory confirmed Penicilliummarneffei infection admitted to the National Hospital for Tropical Diseases in Hanoi, Vietnam, between July 2006 and September 2009. Results 127 patients with P. marneffei infection were identified. All were HIV-infected; median CD4+ T-cell count was 24 cells/μl (IQR:12-48); 76% were men. Common clinical features were fever (92.9%), skin lesions (82.6%), hepatomegaly (61.4%), lymphadenopathy (40.2%), weight loss (59.1%) and cough (49.6%). Concurrent opportunistic infections were present in 22.0%; half of those had tuberculosis. Initial treatment regimens were: itraconazole or ketoconazole capsule (77.2%), amphotericin B (20.5%), and fluconazole (1.6%). In-hospital mortality was 12.6% and showed no significant difference in patients treated with itraconazole (or ketoconazole) and amphotericin B (p = 0.43). Dyspnea, ascites, and increased LDH level were independent predictors of mortality. No seasonality was observed. Conclusion The clinical features, treatments and outcomes of HIV-associated P. marneffei infection in northern Vietnam are similar to those reported in other endemic regions. Dyspnea was an important predictor of mortality. More patients were treated with itraconazole than amphotericin B and no significant difference in treatment outcome was observed. It would be of clinical value to compare the efficacy of oral itraconazole and amphotericin B in a clinical trial. PMID:22897817

  3. Treatment, Outcomes, and Clinical Trial Participation in Elderly Patients With Metastatic Pancreas Adenocarcinoma

    PubMed Central

    Li, Daneng; Capanu, Marinela; Yu, Kenneth H.; Lowery, Maeve A.; Kelsen, David P.; O’Reilly, Eileen M.

    2016-01-01

    Studies on the treatment patterns and outcomes of elderly patients with metastatic pancreas cancer remain limited. Therefore, an analysis of systemic therapy use, clinical trial participation, and outcomes in elderly patients with metastatic pancreas cancer was performed at our institution. Elderly patients who received systemic therapy had a longer survival compared with those who did not. However, therapeutic clinical trial participation was low and should be encouraged Background Pancreas adenocarcinoma has a median age at diagnosis of 71 years. Limited studies have focused on the treatment of elderly patients with pancreas cancer. Patients and Methods An analysis of systemic therapy use, clinical trial participation, and overall outcomes of 237 patients with metastatic pancreas adenocarcinoma ≥ 75 years of age evaluated at Memorial Sloan-Kettering Cancer Center between 2005 and 2013 was undertaken. Results Median overall survival was 7 months for the entire study population. A total of 197 (83%) patients received systemic therapy, which was significantly associated with longer overall survival (P < .01). No significant difference was detected in survival between age groups 75 to 79, 80 to 84, and ≥ 85 years of age among those who received systemic therapy (P = .49). Seventy-seven (32%) patients participated in a clinical trial of whom 13 (5%) patients were enrolled in a therapeutic trial, including no patients aged ≥ 85 years. Multivariate analysis demonstrated that presence of liver metastases (P < .001), performance status (P < .001), and number of systemic agents (P < .001) were significantly associated with survival. Conclusion Receipt of systemic therapy was associated with longer survival in elderly patients ≥ 75 years of age with metastatic pancreas adenocarcinoma. Therapeutic clinical trial participation among these patients was low and future development of prognostic models for appropriate patient selection is warranted. PMID:26072442

  4. Association of sunlight exposure and photoprotection measures with clinical outcome in systemic lupus erythematosus.

    PubMed

    Vilá, L M; Mayor, A M; Valentín, A H; Rodríguez, S I; Reyes, M L; Acosta, E; Vilá, S

    1999-06-01

    This study was designed to explore the relationship of sunlight exposure and ultraviolet (UV) light protection measures with clinical outcome in systemic lupus erythematosus (SLE). A structured questionnaire was administered to sixty Puerto Rican SLE patients, to assess their attitudes and behavior regarding sunlight exposure and photoprotection measures. Medical records were reviewed to evaluate the clinical outcome measures that included: clinical manifestations, number of SLE-related hospitalizations, number of exacerbations and pharmacologic treatment. Almost all (98.3%) patients were well acquainted of sunlight effects on disease activity. Two thirds were exposed to direct sunlight for an average of less than one hour per day and 33.3% for one hour or more. Thirty patients (50%) reported use of sunscreen, with sun protective factor of 15 or greater, when exposed to sunlight. Less than 40% of patients regularly wore hat or long-sleeves clothes to protect from sunlight. Although there were some clinical differences between the groups with different sunlight exposure times, none reached statistical significance. Also, no significant differences were found between the groups in regards to sunlight protective clothes. However, patients that regularly used sunscreen had signif