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Sample records for 1-year clinical outcomes

  1. Residential treatment for homeless female veterans with psychiatric and substance use disorders: effect on 1-year clinical outcomes.

    PubMed

    Harpaz-Rotem, Ilan; Rosenheck, Robert A; Desai, Rani

    2011-01-01

    Limited evidence shows that time-limited residential treatment (RT) is beneficial for homeless people with serious mental illness. The Department of Veterans Affairs has established 11 specialty programs for homeless female veterans. We present data comparing 1-year clinical outcomes in a group of veterans who did and did not receive at least 30 days of RT. Clients of the Homeless Women Veterans Programs were invited to participate in a follow-up study. They were interviewed every 3 months for 1 year. Those who received at least 30 days of RT in the 3 months after program entry (RT group) were compared with other program participants (no or <30 days RT [NRT] group) on measures of community functioning, psychiatric symptoms, and drug and alcohol use during the follow-up. The RT group had better outcomes on employment, social support, housing status, and psychiatric symptoms. They also had significantly increased use of drugs and alcohol compared with the NRT group. Data suggest that RT may have a beneficial effect on mental health outcomes in homeless women. This study, in conjunction with others, suggests that provision of stable housing may be an important element of recovery for homeless women with psychiatric problems, excluding substance use.

  2. Effectiveness of MR Angiography for the Primary Diagnosis of Acute Pulmonary Embolism: Clinical Outcomes at 3 Months and 1 Year

    PubMed Central

    Schiebler, Mark L.; Nagle, Scott K.; François, Christopher J.; Repplinger, Michael D.; Hamedani, Azita G.; Vigen, Karl K.; Yarlagadda, Rajkumar; Grist, Thomas M.; Reeder, Scott B.

    2014-01-01

    Purpose To determine the effectiveness of MR angiography for pulmonary embolism (MRA-PE) in symptomatic patients. Materials and Methods We retrospectively reviewed all patients whom were evaluated for possible pulmonary embolism (PE) using MRA-PE. A 3-month and 1-year from MRA-PE electronic medical record (EMR) review was performed. Evidence for venous thromboembolism (VTE) (or death from PE) within the year of follow-up was the outcome surrogate for this study. Results There were 190 MRA-PE exams performed with 97.4% (185/190) of diagnostic quality. There were 148 patients (120 F: 28 M) that had both a diagnostic MRA-PE exam and 1 complete year of EMR follow-up. There were 167 patients (137 F: 30 M) with 3 months or greater follow-up. We found 83% (139/167) and 81% (120/148) MRA-PE exams negative for PE at 3 months and 1 year, respectively. Positive exams for PE were seen in 14% (23/167). During the 1-year follow-up period, five patients (false negative) were diagnosed with DVT (5/148 = 3.4 %), and one of these patients also experienced a non–life-threatening PE. The negative predictive value (NPV) for MRA-PE was 97% (92–99; 95% CI) at 3 months and 96% (90–98; 95% CI) with 1 year of follow-up. Conclusion The NPV of MRA-PE, when used for the primary diagnosis of pulmonary embolism in symptomatic patients, were found to be similar to the published values for CTA-PE. In addition, the technical success rate and safety of MRA-PE were excellent. PMID:23553735

  3. PEEK Cages versus PMMA Spacers in Anterior Cervical Discectomy: Comparison of Fusion, Subsidence, Sagittal Alignment, and Clinical Outcome with a Minimum 1-Year Follow-Up

    PubMed Central

    Krüger, Marie T.; Sircar, Ronen; Kogias, Evangelos; Scholz, Christoph; Volz, Florian; Scheiwe, Christian; Hubbe, Ulrich

    2014-01-01

    Purpose. To compare radiographic and clinical outcomes after anterior cervical discectomy in patients with cervical degenerative disc disease using PEEK cages or PMMA spacers with a minimum 1-year follow-up. Methods. Anterior cervical discectomy was performed in 107 patients in one or two levels using empty PEEK cages (51 levels), Sulcem PMMA spacers (49 levels) or Palacos PMMA spacers (41 levels) between January, 2005 and February, 2009. Bony fusion, subsidence, and sagittal alignment were retrospectively assessed in CT scans and radiographs at follow-up. Clinical outcome was measured using the VAS, NDI, and SF-36. Results. Bony fusion was assessed in 65% (PEEK cage), 57% (Sulcem), and 46% (Palacos) after a mean follow-up of 2.5 years. Mean subsidence was 2.3–2.6 mm without significant differences between the groups. The most pronounced loss of lordosis was found in PEEK cages (−4.1°). VAS was 3.1 (PEEK cage), 3.6 (Sulcem), and 2.7 (Palacos) without significant differences. Functional outcome in the PEEK cage and Palacos group was superior to the Sulcem group. Conclusions. The substitute groups showed differing fusion rates. Clinical outcome, however, appears to be generally not correlated with fusion status or subsidence. We could not specify a superior disc substitute for anterior cervical discectomy. This trial is registered with DRKS00003591. PMID:25110734

  4. Cognitive therapy for autogenous and reactive obsessions: clinical and cognitive outcomes at post-treatment and 1-year follow-up.

    PubMed

    Belloch, Amparo; Cabedo, Elena; Carrió, Carmen; Larsson, Christina

    2010-08-01

    This study provides data about the differential effectiveness of cognitive therapy (CT) for obsessive-compulsive disorder (OCD) symptom presentation. Two OCD manifestations, autogenous and reactive, are considered. Seventy OCD patients started CT; 81.40% completed it and 72.85% were available 1 year later. Fifteen of the 57 treatment completers had autogenous obsessions, whereas 33 had reactive obsessions. Nine patients had both obsession modalities. Reactive patients were more severe, as they scored higher on thought suppression and on the dysfunctional beliefs of intolerance to uncertainty and perfectionism. Autogenous patients scored higher on the over-importance of thoughts beliefs. Although CT was effective in reducing OCD severity and the ascription to dysfunctional beliefs and neutralizing strategies in both the autogenous and the reactive patients, a significantly better outcome was observed for the autogenous patients, both at post-treatment (with 73.33% recovering versus 33.33% for reactives) and 1 year later.

  5. Impact of CYP2C19 Variants on Clinical Efficacy of Clopidogrel and 1-Year Clinical Outcomes in Coronary Heart Patients Undergoing Percutaneous Coronary Intervention

    PubMed Central

    Sun, Hong; Qu, Qiang; Chen, Zhen-Fan; Tan, Sheng-Lan; Zhou, Hai-Jun; Qu, Jian; Chen, Hui

    2016-01-01

    The impact of pharmacogenetic variants of cytochrome P450 2C19 (CYP2C19) on clopidogrel-mediated effects on platelet inhibition, inflammatory response and endothelial function, as well as risk of major adverse cardiovascular events (MACE), in coronary heart patients undergoing percutaneous coronary intervention (PCI) was investigated. To this end, we assessed the residual platelet aggregation rate (RPA), maximal aggregation rate (MAR) and plasma levels of sCD40L, sP-selectin, MMP-9, sVCAM-1 and sE-selectin after 24 h of PCI in 559 patients treated with clopidogrel and followed up for 1 year for evidence of MACE. CYP2C19 *2 and *3 variants were identified using a clopidogrel-sensitive gene detection kit. Our results showed higher RPA and MAR as well as increased sE-selectin, sCD40L, sP-selectin, MMP-9, and sVCAM-1 levels in CYP2C19 intermediate metabolizer (IM, CYP2C19*1/*2, or *1/*3), poor metabolizer (PM, CYP2C19*2/*2, *2/*3, or *3/*3) and combined IM+PM groups, relative to those in extensive metabolizers (EM, CYP2C19*1/*1). In total, 519 patients completed 1 year of follow-up, among which 69 (13.3%) experienced MACE. The risk of MACE in CYP2C19 IM+PM patients was 2.664 times higher than that in CYP2C19 EM patients (OR = 2.664 (1.397–5.193), P = 0.004). The data suggest that CYP2C19*2 and *3 variants modulate the drug efficacy of clopidogrel in coronary heart patients undergoing PCI and further enhance the risk of MACE. Accordingly, CYP2C19 pharmacogenetic profiling may be beneficial for coronary heart patients undergoing PCI to predict the efficacy of treatment with clopidogrel. We propose that IM and PM patients should benefit from treatment with higher clopidogrel doses to improve efficacy and reduce the incidence of MACE. PMID:27932982

  6. Acquired childhood aphasia. Outcome 1 year after onset.

    PubMed

    Loonen, M C; van Dongen, H R

    1990-12-01

    The effects of the variables age at onset, cause, severity and bilaterality of lesion, and type of aphasia on course and outcome were investigated in a group of 28 aphasic children. Analysis of spontaneous speech and tests of auditory verbal comprehension were used to determine the presence of aphasia. The severity of the cerebral lesion was assessed using a rating scale for computed tomographic scans. Most of the children had not recovered completely 1 year after onset. Recovery was significantly different according to etiological categories. Complete recovery was seen in the majority of traumatic cases.

  7. Cognitive dysfunction at baseline predicts symptomatic 1-year outcome in first-episode schizophrenics.

    PubMed

    Moritz, S; Krausz, M; Gottwalz, E; Lambert, M; Perro, C; Ganzer, S; Naber, D

    2000-01-01

    The present study addresses the consequences of cognitive disturbances on symptomatic outcome. Fifty-three first-episode schizophrenics were reassessed (n = 32) 1 year after admission. Simple regression analyses revealed that several self-perceived cognitive deficits at baseline as measured with the Frankfurt Complaint Questionnaire significantly predicted increased Brief Psychiatric Rating Scale global scores at follow-up (p = 0.05 to p = 0.005). A stepwise regression analysis proved memory dysfunction to be the strongest predictor of symptomatic worsening (p = 0.005). It is suggested that the exploration and treatment of neuropsychological deficits in schizophrenia is of great clinical importance with regard to its impact on both functional and symptomatic outcome in schizophrenia.

  8. Minimally invasive facet restoration implant for chronic lumbar zygapophysial pain: 1-year outcomes

    PubMed Central

    2014-01-01

    Background The zygapophysial (facet) joint is the primary pain generator in one third of chronic low back pain cases. Current treatment options include temporarily palliative nonsurgical approaches, facet injections, radiofrequency denervation, and, rarely, lumbar arthrodesis. The purpose of this study was to assess the safety and effectiveness of a minimally invasive implant intended to restore facet joint function in patients with chronic lumbar facetogenic pain. Methods This prospective, multi-center feasibility study enrolled patients with confirmed lumbar facetogenic joint pain at 1 or 2 levels who underwent at least 6 months of unsuccessful nonoperative care. Patients received a minimally invasive implant (Glyder® Facet Restoration Device, Zyga Technology, Inc., Minnetonka, MN) intended to restore facet joint function while preserving the native anatomy. Main outcomes included back pain severity using a visual analogue scale, back-specific disability using the Oswestry Disability Index (ODI), and adverse events adjudicated by an independent Clinical Events Committee. Results Of 40 enrolled patients, 37 patients received the facet restoration implant and 34 patients had complete 1-year follow-up data available. Over the 1-year follow-up period, back pain severity decreased 41% and ODI decreased 34%, on average. Freedom from a device- or procedure-related serious adverse event through 1 year was 84%. Implant migration was observed in 3 patients and implant expulsion from the facet joint occurred in 3 patients. In total, 2 (5.4%) patients underwent implant removal through 1 year post-treatment. Conclusions A minimally invasive facet restoration implant is a promising treatment option in select patients with chronic lumbar zygapophysial pain who have exhausted nonsurgical treatments, with therapeutic benefit persisting at 1 year follow-up. PMID:26628910

  9. Glomerular filtration rate in patients with atrial fibrillation and 1-year outcomes

    PubMed Central

    Boriani, Giuseppe; Laroche, Cécile; Diemberger, Igor; Popescu, Mircea Ioachim; Rasmussen, Lars Hvilsted; Petrescu, Lucian; Crijns, Harry J. G. M.; Tavazzi, Luigi; Maggioni, Aldo P.; Lip, Gregory Y. H.

    2016-01-01

    We assessed 1-year outcomes in patients with atrial fibrillation enrolled in the EurObservational Research Programme AF General Pilot Registry (EORP-AF), in relation to kidney function, as assessed by glomerular filtration rate (eGFR). In a cohort of 2398 patients (median age 69 years; 61% male), eGFR (ml/min/1.73 m2) calculated using the CKD-EPI formula was ≥80 in 35.1%, 50–79 in 47.2%, 30–49 in 13.9% and <30 in 3.7% of patients. In a logistic regression analysis, eGFR category was an independent predictor of stroke/TIA or death, with elevated odds ratios associated with severe to mild renal impairment, ie. eGFR < 30 ml/min/1.73 m2 [OR 3.641, 95% CI 1.572–8.433, p < 0.0001], 30–49 ml/min/1.73 m2 [OR 3.303, 95% CI 1.740–6.270, p = 0.0026] or 50–79 ml/min/1.73 m2 [OR 2.094, 95% CI 1.194–3.672, p = 0.0003]. The discriminant capability for the risk of death was tested among various eGFR calculation algorithms: the best was the Cockcroft-Gault equation adjusted for BSA, followed by Cockcroft-Gault equation, and CKD-EPI equation, while the worst was the MDRD equation. In conclusion in this prospective observational registry, renal function was a major determinant of adverse outcomes at 1 year, and even mild or moderate renal impairments were associated with an increased risk of stroke/TIA/death. PMID:27466080

  10. Impact of Different Childhood Adversities on 1-Year Outcomes of Psychotic Disorder in the Genetics and Psychosis Study.

    PubMed

    Trotta, Antonella; Murray, Robin M; David, Anthony S; Kolliakou, Anna; O'Connor, Jennifer; Di Forti, Marta; Dazzan, Paola; Mondelli, Valeria; Morgan, Craig; Fisher, Helen L

    2016-03-01

    While the role of childhood adversity in increasing the risk of psychosis has been extensively investigated, it is not clear what the impact of early adverse experiences is on the outcomes of psychotic disorders. Therefore, we investigated associations between childhood adversity and 1-year outcomes in 285 first-presentation psychosis patients. Exposure to childhood adversity prior to 17 years of age was assessed using the Childhood Experience of Care and Abuse Questionnaire. Data on illness course, symptom remission, length of psychiatric hospitalization, compliance with medication, employment, and relationship status were extracted from clinical records for the year following first contact with mental health services for psychosis. Seventy-one percent of patients reported exposure to at least 1 type of childhood adversity (physical abuse, sexual abuse, parental separation, parental death, disrupted family arrangements, or being taken into care). No robust associations were found between childhood adversity and illness course or remission. However, childhood physical abuse was associated with almost 3-fold increased odds of not being in a relationship at 1-year follow-up compared to patients who did not report such adverse experiences. There was also evidence of a significant association between parental separation in childhood and longer admissions to psychiatric wards during 1-year follow-up and 2-fold increased odds of noncompliance with medication compared to those not separated from their parents. Therefore, our findings suggest that there may be some specificity in the impact of childhood adversity on service use and social functioning among psychosis patients over the first year following presentation to mental health services.

  11. The first simultaneous kidney-adrenal gland-pancreas transplantation: outcome at 1 year.

    PubMed

    Vouillarmet, J; Buron, F; Houzard, C; Carlier, M C; Chauvet, C; Brunet, M; Thivolet, C; Morelon, E; Badet, L

    2013-07-01

    Adrenal insufficiency is a rare but life-threatening disease. Replacement therapy sometimes fails to prevent an acute adrenal crisis and most often does not lead to restoration of well-being. We report here the 1-year outcome of the first simultaneous kidney-adrenal gland-pancreas transplantation in a 33-year-old patient with type 1 diabetes and concomitant autoimmune adrenal insufficiency. En bloc left adrenal gland and kidney grafts were anastomosed on the left iliac vessels in normal vascular conditions and the pancreas graft was anastomosed on the right iliac vessels. The immunosuppressive regimen was not modified by the addition of the adrenal gland. We observed no additional morbidity due to the adrenal gland transplantation, as there were no surgical complications. One-year kidney and pancreas graft functions were satisfactory (estimated glomerular filtration rate: 55 mL/min/1.73 m(2) and HbA1c: 4.8%). The adrenal graft functioned well at 12 months with a normalization of cortisol and aldosterone baseline levels. Functional imaging at 3 months showed good uptake of [(123) I]-metaiodobenzylguanidine by the adrenal graft. Transplantation of the adrenal gland en bloc with the left kidney appears to be a good therapeutic option in patients with adrenal insufficiency awaiting kidney or kidney-pancreas transplantation.

  12. Randomized controlled trial of the focus parent training for toddlers with autism: 1-year outcome.

    PubMed

    Oosterling, Iris; Visser, Janne; Swinkels, Sophie; Rommelse, Nanda; Donders, Rogier; Woudenberg, Tim; Roos, Sascha; van der Gaag, Rutger Jan; Buitelaar, Jan

    2010-12-01

    This randomized controlled trial compared results obtained after 12 months of nonintensive parent training plus care-as-usual and care-as-usual alone. The training focused on stimulating joint attention and language skills and was based on the intervention described by Drew et al. (Eur Child Adolesc Psychiatr 11:266-272, 2002). Seventy-five toddlers with autism spectrum disorder (65 autism, 10 PDD-NOS, mean age = 34.4 months, SD = 6.2) were enrolled. Analyses were conducted on a final sample of 67 children (lost to follow-up = 8). No significant intervention effects were found for any of the primary (language), secondary (global clinical improvement), or mediating (child engagement, early precursors of social communication, or parental skills) outcome variables, suggesting that the 'Focus parent training' was not of additional value to the more general care-as-usual.

  13. Bactercline®-coated implants: Clinical results up to 1 year after loading from a controlled clinical trial

    PubMed Central

    Carinci, Francesco; Grecchi, Emma; Bignozzi, Carlo Alberto; Murmura, Giovanna; Piattelli, Adriano; Scarano, Antonio

    2012-01-01

    Background: Titanium dioxide exists in three different crystal lattices, anatase, rutile, and brookite. Anatase coating releases, under ultraviolet (UV) irradiation, free radicals such as ·OH, O2-, HO2-, and H2O2. This potent oxidizing power characteristically results in the lysis of bacteria and other organic substances. The purpose of this study was to evaluate the bone response to implants made of titanium alloy or coated with a new combination of anatase and Bactercline® product. Materials and Methods: In the period between July 2009 and June 2010, 26 patients (10 females and 16 males; median age 51 ± 11 years, min. 27 years, max. 72 years) were operated and 62 implants were inserted. Lost fixtures and peri-implant bone resorption were considered as predictors of clinical outcomes. Pearson χ2-test was used. Prosthesis and implant failures, any complications after loading, and peri-implant marginal bone-level changes were assessed by a masked assessor. All patients were followed up to 1 year after loading. Results: No implant was lost. Average bone resorption around implant was 0.33 mm (both for 25 standard and 37 Bactercline-coated implants), and thus no statistical difference was detected. Conclusion: These results shown that no adverse effects on osseo-integration were present. PMID:23814572

  14. Project FLAVOR: 1-Year Outcomes of a Multicultural, School-Based Smoking Prevention Curriculum for Adolescents.

    PubMed

    Unger, Jennifer B; Chou, Chih-Ping; Palmer, Paula H; Ritt-Olson, Anamara; Gallaher, Peggy; Cen, Steven; Lichtman, Kara; Azen, Stanley; Johnson, C Anderson

    2004-02-01

    To evaluate a multicultural smoking prevention curriculum, 16 schools were randomized to receive the multicultural curriculum or a standard curriculum and program effects on 1-year smoking initiation among 1430 never smokers were assessed. Hispanic boys who received the multicultural curriculum were less likely to initiate smoking than were those who received the standard curriculum; effects were insignificant among other groups. The prevention effect among Hispanic boys is encouraging, but additional research is needed to improve prevention effects among other groups.

  15. Prognosis of stroke in the south of Greece: 1 year mortality, functional outcome and its determinants: the Arcadia Stroke Registry

    PubMed Central

    Vemmos, K; Bots, M; Tsibouris, P; Zis, V; Takis, C; Grobbee, D; Stamatelopoulos, S

    2000-01-01

    OBJECTIVES—For Greece, data on incidence of stroke, type of stroke, and prognosis of stroke is limited. Recently, results on incidence of stroke were published. Here 1 year mortality, functional outcome after a first ever stroke, and determinants of the prognosis are described.
METHODS—A population based registry was established in the Arcadia area, located in eastern central Peloponessos in southern Greece. Between 1 November 1993 and 31 October 1995, 555 patients with a first ever stroke were identified using information from death certificates, hospital records, public health centres and general practitioners. Extensive information on cardiovascular risk factors and stroke characteristics was obtained. After 1 year a modified Rankin score was determined in all surviving patients.
RESULTS—After 1 year of follow up, 204 (36.8%) patients died. The probability of survival 1 year after stroke was higher for cerebral infarction than for intracerebral haemorrhage; 67.8% (95% confidence interval (95% CI) 64-72) and 46.4% (35-57), respectively. Of the survivors, 68.9% had either no symptoms or symptoms that would not interfere with their capacity to look after themselves (Rankin score 0 to 2). Increasing age and low Glasgow coma scale score were the most powerful predictors of death within 1 year (p<0.01), whereas increasing age, atrial fibrillation, and low Glasgow coma scale score were the most important predictors of functional outcome 1 year after a stroke (p<0.01).
CONCLUSIONS—One year mortality from stroke in Greece is similar to that of other industrialised countries. The most important factors that affect the prognosis of a patient with a first ever stroke are increasing age, stroke severity, and atrial fibrillation.

 PMID:11032610

  16. DTI study of Children with Congenital Hydrocephalus: 1 Year Post-Surgical Outcomes

    PubMed Central

    Mangano, Francesco T.; Altaye, Mekibib; McKinstry, Robert C.; Shimony, Joshua S.; Powell, Stephanie K.; Phillips, Jannel M.; Barnard, Holly; Limbrick, David D.; Holland, Scott K.; Jones, Blaise V.; Dodd, Jonathon; Simpson, Sarah; Deanna, Mercer; Rajagopal, Akila; Bidwell, Sarah; Yuan, Weihong

    2016-01-01

    Object To investigate white matter structural abnormalities using diffusion tensor imaging (DTI) in children with hydrocephalus before CSF diversionary surgery (including ventriculoperitoneal shunting and endoscopic third ventriculoscopy) and the course of recovery post-surgery in association with neuropsychological and behavioral outcome. Methods This was a prospective study that included 54 children with congenital hydrocephalus (21F/33M; age range: 0.03–194.5 months) who underwent surgery and 64 normal controls (30F/34M, age range: 0.30–197.75 months). DTI and neurodevelopmental outcome data were collected once in the control group and at pre-surgery, 3-month, and 12-month post-surgery in the patients. DTI measures, including fractional anisotropy (FA), mean diffusivity (MD), axial diffusivity (AD), and radial diffusivity (RD) values were extracted from the genu of corpus callosum (gCC) and the posterior limb of internal capsule (PLIC). Group analysis was performed first cross-sectionally to quantify DTI abnormalities at three time points by comparing the controls and the patients group at the three time points separately. Longitudinal comparisons were conducted pairwise between different time points in patients whose data were acquired at multiple time points. Neurodevelopmental data were collected and analyzed using the Adaptive Behavior Assessment System, Second Edition (ABAS-II) and the Bayley Scales of Infant Development, Third Edition (Bayley-III). Correlation analyses were performed between DTI and behavioral outcomes. Results Significant DTI abnormalities were found in both the gCC (lower FA and higher MD, AD, and RD) and the PLIC (higher FA, lower AD and RD) at pre-surgery. The DTI measures in the gCC remained mostly abnormal at 3-month and 12-month post-surgery. The DTI abnormalities in the PLIC were significant in FA and AD at 3-month post-surgery but did nor persist when tested at 12-month post-surgery. Significant longitudinal DTI changes in the

  17. Diffusion tensor imaging study of pediatric patients with congenital hydrocephalus: 1-year postsurgical outcomes.

    PubMed

    Mangano, Francesco T; Altaye, Mekibib; McKinstry, Robert C; Shimony, Joshua S; Powell, Stephanie K; Phillips, Jannel M; Barnard, Holly; Limbrick, David D; Holland, Scott K; Jones, Blaise V; Dodd, Jonathan; Simpson, Sarah; Mercer, Deanna; Rajagopal, Akila; Bidwell, Sarah; Yuan, Weihong

    2016-09-01

    OBJECTIVE The purpose of this study was to investigate white matter (WM) structural abnormalities using diffusion tensor imaging (DTI) in children with hydrocephalus before CSF diversionary surgery (including ventriculoperitoneal shunt insertion and endoscopic third ventriculostomy) and during the course of recovery after surgery in association with neuropsychological and behavioral outcome. METHODS This prospective study included 54 pediatric patients with congenital hydrocephalus (21 female, 33 male; age range 0.03-194.5 months) who underwent surgery and 64 normal controls (30 female, 34 male; age range 0.30-197.75 months). DTI and neurodevelopmental outcome data were collected once in the control group and 3 times (preoperatively and at 3 and 12 months postoperatively) in the patients with hydrocephalus. DTI measures, including fractional anisotropy (FA), mean diffusivity (MD), axial diffusivity (AD), and radial diffusivity (RD) values were extracted from the genu of the corpus callosum (gCC) and the posterior limb of internal capsule (PLIC). Group analysis was performed first cross-sectionally to quantify DTI abnormalities at 3 time points by comparing the data obtained in the hydrocephalus group for each of the 3 time points to data obtained in the controls. Longitudinal comparisons were conducted pairwise between different time points in patients whose data were acquired at multiple time points. Neurodevelopmental data were collected and analyzed using the Adaptive Behavior Assessment System, Second Edition, and the Bayley Scales of Infant Development, Third Edition. Correlation analyses were performed between DTI and behavioral measures. RESULTS Significant DTI abnormalities were found in the hydrocephalus patients in both the gCC (lower FA and higher MD, AD, and RD) and the PLIC (higher FA, lower AD and RD) before surgery. The DTI measures in the gCC remained mostly abnormal at 3 and 12 months after surgery. The DTI abnormalities in the PLIC were

  18. Deep Sclerectomy With a New Nonabsorbable Uveoscleral Implant (Esnoper-Clip): 1-Year Outcomes

    PubMed Central

    Parera-Arranz, Angels; Romera-Romera, Pau; Castellvi-Manent, Jordi; Sabala-Llopart, Antoni; de la Cámara-Hermoso, Julio

    2015-01-01

    Purpose: To report the safety and the effectiveness of deep sclerectomy (DS) with a new nonabsorbable uveoscleral hema implant (Esnoper-Clip) designed to increase trabecular and uveoscleral outflow and to achieve higher intrascleral blebs. Materials and Methods: Twenty-seven eyes of 27 patients with open-angle glaucoma, who underwent DS with an Esnoper-Clip implant, were included in this study. All patients were followed up after 12 months. Results: A significant decrease in intraocular pressure was observed after surgery, changing from a preoperative mean of 26.6±5.2 mm Hg to a postoperative mean of 15.3±5 mm Hg (P<0.001) at 12 months. There was also a significant reduction in the number of glaucoma drugs needed, varying from 2.5 per patient to 0.3 (P<0.001) 1 year after surgery. The main intrascleral lake height and volume at 12 months was 0.7±0.1 mm and 3.9±1.3 mm3, respectively. No intraoperative complications occurred. The main postoperative complications were a positive Seidel test result at 24 hours in 2 eyes (7.4%), hyphema in 2 eyes (7.4%), and choroidal detachment in 1 eye (3.7%). All these complications resolved successfully. The need for additional mitomycin-C injections was recorded in 4 eyes (14.8%), twice in 2 of them. Twelve eyes (44.4%) underwent postsurgical Nd:YAG laser goniopuncture with a mean time between surgery and this procedure of 4.3 months. Mean intraocular pressure after Nd:YAG laser goniopuncture decreased from 19.2 to 15.5 mm Hg (P<0.001). Conclusion: DS with an uveoscleral hema implant (Esnoper-Clip) is a safe and effective technique for the management of open-angle glaucoma. PMID:25836660

  19. Effects of Head Start REDI on children's outcomes 1 year later in different kindergarten contexts.

    PubMed

    Bierman, Karen L; Nix, Robert L; Heinrichs, Brenda S; Domitrovich, Celene E; Gest, Scott D; Welsh, Janet A; Gill, Sukhdeep

    2014-01-01

    One year after participating in the Research-based, Developmentally Informed (REDI) intervention or "usual practice" Head Start, the learning and behavioral outcomes of 356 children (17% Hispanic, 25% African American; 54% girls; Mage  = 4.59 years at initial assessment) were assessed. In addition, their 202 kindergarten classrooms were evaluated on quality of teacher-student interactions, emphasis on reading instruction, and school-level student achievement. Hierarchical linear analyses revealed that the REDI intervention promoted kindergarten phonemic decoding skills, learning engagement, and competent social problem-solving skills, and reduced aggressive-disruptive behavior. Intervention effects on social competence and inattention were moderated by kindergarten context, with effects strongest when children entered schools with low student achievement. Implications are discussed for developmental models of school readiness and early educational programs.

  20. MRI as outcome measure in facioscapulohumeral muscular dystrophy: 1-year follow-up of 45 patients.

    PubMed

    Andersen, Grete; Dahlqvist, Julia R; Vissing, Christoffer R; Heje, Karen; Thomsen, Carsten; Vissing, John

    2017-03-01

    There is no effective treatment available for facioscapulohumeral muscular dystrophy type 1 (FSHD1), but emerging therapies are under way that call for a better understanding of natural history in this condition. In this prospective, longitudinal study, we used quantitative MRI to assess yearly disease progression in patients with FSHD1. Ambulatory patients with confirmed diagnosis of FSHD1 (25/20 men/women, age 20-75 years, FSHD score: 0-12) were tested with 359-560-day interval between tests. Using the MRI Dixon technique, muscle fat replacement was evaluated in paraspinal, thigh, and calf muscles. Changes were compared with those in FSHD score, muscle strength (hand-held dynamometry), 6-minute-walk-distance, 14-step-stair-test, and 5-time-sit-to-stand-test. Composite absolute fat fraction of all assessed muscles increased by 0.036 (CI 0.026-0.046, P < 0.001), with increases in all measured muscle groups. The clinical severity FSHD score worsened (10%, P < 0.05), muscle strength decreased over the hip (8%), neck (8%), and back (17%) (P < 0.05), but other strength measures, 6-minute-walk-distance, 5-times-sit-to-stand-test, and 14-step-stair-test were unchanged. Changes in muscle strength, FSHD score, and fat fraction did not correlate. This first study to systemically monitor quantitative fat replacement longitudinally in FSHD1 shows that MRI provides an objective measure of disease progression, often before changes can be appreciated in strength and functional tests. The study indicates that quantitative MRI can be a helpful end-point in follow-up and therapeutic trials of patients with FSHD1.

  1. 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

  2. Results of 1 year of clinical experience with independent dose calculation software for VMAT fields

    PubMed Central

    Colodro, Juan Fernando Mata; Berna, Alfredo Serna; Puchades, Vicente Puchades; Amores, David Ramos; Baños, Miguel Alcaraz

    2014-01-01

    It is widely accepted that a redundant independent dose calculation (RIDC) must be included in any treatment planning verification procedure. Specifically, volumetric modulated arc therapy (VMAT) technique implies a comprehensive quality assurance (QA) program in which RIDC should be included. In this paper, the results obtained in 1 year of clinical experience are presented. Eclipse from Varian is the treatment planning system (TPS), here in use. RIDC were performed with the commercial software; Diamond® (PTW) which is capable of calculating VMAT fields. Once the plan is clinically accepted, it is exported via Digital Imaging and Communications in Medicine (DICOM) to RIDC, together with the body contour, and then a point dose calculation is performed, usually at the isocenter. A total of 459 plans were evaluated. The total average deviation was -0.3 ± 1.8% (one standard deviation (1SD)). For higher clearance the plans were grouped by location in: Prostate, pelvis, abdomen, chest, head and neck, brain, stereotactic radiosurgery, lung stereotactic body radiation therapy, and miscellaneous. The highest absolute deviation was -0.8 ± 1.5% corresponding to the prostate. A linear fit between doses calculated by RIDC and by TPS produced a correlation coefficient of 0.9991 and a slope of 1.0023. These results are very close to those obtained in the validation process. This agreement led us to consider this RIDC software as a valuable tool for QA in VMAT plans. PMID:25525309

  3. Results of 1 year of clinical experience with independent dose calculation software for VMAT fields.

    PubMed

    Colodro, Juan Fernando Mata; Berna, Alfredo Serna; Puchades, Vicente Puchades; Amores, David Ramos; Baños, Miguel Alcaraz

    2014-10-01

    It is widely accepted that a redundant independent dose calculation (RIDC) must be included in any treatment planning verification procedure. Specifically, volumetric modulated arc therapy (VMAT) technique implies a comprehensive quality assurance (QA) program in which RIDC should be included. In this paper, the results obtained in 1 year of clinical experience are presented. Eclipse from Varian is the treatment planning system (TPS), here in use. RIDC were performed with the commercial software; Diamond(®) (PTW) which is capable of calculating VMAT fields. Once the plan is clinically accepted, it is exported via Digital Imaging and Communications in Medicine (DICOM) to RIDC, together with the body contour, and then a point dose calculation is performed, usually at the isocenter. A total of 459 plans were evaluated. The total average deviation was -0.3 ± 1.8% (one standard deviation (1SD)). For higher clearance the plans were grouped by location in: Prostate, pelvis, abdomen, chest, head and neck, brain, stereotactic radiosurgery, lung stereotactic body radiation therapy, and miscellaneous. The highest absolute deviation was -0.8 ± 1.5% corresponding to the prostate. A linear fit between doses calculated by RIDC and by TPS produced a correlation coefficient of 0.9991 and a slope of 1.0023. These results are very close to those obtained in the validation process. This agreement led us to consider this RIDC software as a valuable tool for QA in VMAT plans.

  4. 1-year follow-up after radiofrequency tonsillotomy and laser tonsillotomy in children: a prospective, double-blind, clinical study.

    PubMed

    Stelter, Klaus; Ihrler, Stephan; Siedek, Vanessa; Patscheider, Martin; Braun, Thomas; Ledderose, Georg

    2012-02-01

    In the last decade, tonsillotomy has come into vogue again, whereas the number of tonsillectomies is decreasing rapidly. In a previous study, the tonsillotomy with laser or radiofrequency therapy proved as a safe and effective procedure with minimal pain and hemorrhage. This follow-up study determines which method is more effective with respect to long-term outcome, recurrence of tonsillar hyperplasia and recurrence of tonsillitis. A prospective, randomised, double-blinded controlled clinical study was conducted at the Department of Otorhinolaryngology of the Ludwig-Maximilians-University, Munich, Germany. Twenty-six children with tonsillar hypertrophy were included. Tonsillotomy was performed on one side with monopolar radiofrequency and on the other side with a carbon dioxide laser. Exactly 1 year after the procedure, all 26 patients were documented by digital photography to define a possible recurrence of tonsillar hyperplasia. All parents were asked for occurring tonsillitis and fulfilled the Glasgow Children's Benefit Inventory (GCBI) for health-related quality of life after surgical procedures. In seven children, a slightly visible recurrence of the tonsillar hyperplasia occurred, without any symptoms or correlation to the different methods and sides. One child with recurrent tonsillitis and hyperplasia had to be tonsillectomized 8 months after the initial tonsillotomy procedure. The specimen showed open crypts with bacterial infection in the deep. The GCBI resulted in highly significant benefits of the surgery in all categories and subcategories. In conclusion, both methods, the laser tonsillotomy and the radiofrequency method, were equal concerning the effectiveness and safety after 1 year. Further investigations have to aim at the long-term outcome after tonsillotomy in patients with recurrent infections.

  5. Impact of attachment style on the 1-year outcome of persons with an at-risk mental state for psychosis.

    PubMed

    Quijada, Yanet; Kwapil, Thomas R; Tizón, Jorge; Sheinbaum, Tamara; Barrantes-Vidal, Neus

    2015-08-30

    Attachment theory provides key elements for understanding the psychosocial vulnerability for and response to the emergence of psychosis. This study examined (1) whether pre-treatment attachment styles are differentially associated with clinical and functional outcome in at-risk mental state (ARMS) for psychosis patients across one year of psychosocial treatment, and (2) whether clinical change is associated with changes in attachment ratings beyond the effect of baseline symptom severity. Thirty-eight ARMS patients (mean age=16.7, S.D.=5.9) identified from a psychosocial needs-adapted treatment were evaluated with the Positive and Negative Syndrome Scale, the Global Assessment of Functioning, and the Relationships Questionnaire. Lower levels of insecure-avoidant attachment predicted better clinical outcomes, whereas higher levels of secure attachment predicted improvement in functioning. A decrease in preoccupied-anxious attachment was associated with symptom amelioration. The findings suggest that the intensity of insecure attachment plays a significant role in the clinical outcome of ARMS patients involved in psychosocial treatment. Reducing the levels of insecure attachment in the therapeutic setting probably favors a better course in the early phases of psychosis. Furthermore, the finding that negative models of the self and others were associated with symptom outcome is consistent with current psychosocial models of psychosis.

  6. Modifiable risk factors control and its relationship with 1 year outcomes after coronary artery bypass surgery: insights from the REACH registry

    PubMed Central

    Mehta, Rajendra H.; Bhatt, Deepak L.; Steg, Ph. Gabriel; Goto, Shinya; Hirsch, Alan T.; Liau, Chiau-Suong; Röther, Joachim; Wilson, Peter W.F.; Richard, Alain-Jean; Eagle, Kim A.; Ohman, E. Magnus

    2008-01-01

    Aims To evaluate the influence of achieving secondary prevention target treatment goals for cardiovascular (CV) risk factors on clinical outcomes in patients with prior coronary artery bypass surgery (CABG). Methods and results Accordingly, we analysed treatment to target goals in patients with prior CABG and atherothrombotic disease or known risk factors (diabetes, hypertension, hypercholesterolaemia, smoking, obesity) enrolled in the global REduction in Atherothrombosis for Continued Health (REACH) Registry, and their association with 1 year outcomes. A total of 13 907 of 68 236 patients (20.4%) in REACH had a history of prior CABG, and 1 year outcomes data were available for 13 207 of these. At baseline <25, 25–<50, 50–<75, and ≥75% risk factors were at goal in 3.7, 12.9, 31.7, and 51.7% of patients, respectively. One-year composite rates of CV death, non-fatal MI, non-fatal stroke were inversely related to the proportion of risk factors at goal at baseline (age, gender, and region adjusted rates 6.1, 5.6, 5.2, and 4.3% of patients with <25, 25–<50, 50–<75, and >75% risk factors at goal, respectively; P for trend 0.059). Conclusion Risk-factor control varied greatly in CABG patients. Although CABG patients are frequently treated with appropriate therapies, these treatments fail to achieve an adequate level of prevention in many. This failure was associated with a trend for worse age-, gender-, and region-adjusted clinical outcomes. Thus, perhaps secondary prevention after CABG needs to focus on more comprehensive modification of risk factors to target goals in the hope of preventing subsequent CV events, and represents an opportunity to improve CV health. PMID:18996953

  7. The Chicago Parent Program: Comparing 1-Year Outcomes for African American and Latino Parents of Young Children

    PubMed Central

    Breitenstein, Susan M.; Gross, Deborah; Fogg, Louis; Ridge, Alison; Garvey, Christine; Julion, Wrenetha; Tucker, Sharon

    2012-01-01

    Data were merged from two prevention randomized trials testing 1-year outcomes of a parenting skills program, the Chicago Parent Program (CPP), and comparing its effects for African-American (n=291) versus Latino (n=213) parents and their preschool children. Compared to controls, intervention parents had improved self-efficacy, used less corporal punishment and more consistent discipline, and demonstrated more positive parenting. Intervention children had greater reductions in behavior problems based on parent-report, teacher-report, and observation. Although improvements from CPP were evident for parents in both racial/ethnic groups, Latino parents reported greater improvements in their children’s behavior and in parenting self-efficacy but exhibited greater decreases in praise. Findings support the efficacy of the CPP for African American and Latino parents and young children from low-income urban communities. PMID:22622598

  8. The Chicago Parent Program: comparing 1-year outcomes for African American and Latino parents of young children.

    PubMed

    Breitenstein, Susan M; Gross, Deborah; Fogg, Louis; Ridge, Alison; Garvey, Christine; Julion, Wrenetha; Tucker, Sharon

    2012-10-01

    Data were merged from two prevention randomized trials testing 1-year outcomes of a parenting skills program, the Chicago Parent Program (CPP) and comparing its effects for African-American (n = 291) versus Latino (n = 213) parents and their preschool children. Compared to controls, intervention parents had improved self-efficacy, used less corporal punishment and more consistent discipline, and demonstrated more positive parenting. Intervention children had greater reductions in behavior problems based on parent-report, teacher-report, and observation. Although improvements from the CPP were evident for parents in both racial/ethnic groups, Latino parents reported greater improvements in their children's behavior and in parenting self-efficacy but exhibited greater decreases in praise. Findings support the efficacy of the CPP for African American and Latino parents and young children from low-income urban communities.

  9. Management and 1-year outcomes of patients with atrial fibrillation in the Middle East: Gulf survey of atrial fibrillation events.

    PubMed

    Zubaid, Mohammad; Rashed, Wafa A; Alsheikh-Ali, Alawi A; Al-Zakwani, Ibrahim; AlMahmeed, Wael; Shehab, Abdullah; Sulaiman, Kadhim; Qudaimi, Ahmed Al; Asaad, Nidal; Amin, Haitham

    2015-05-01

    We describe management and outcomes of patients with nonvalvular atrial fibrillation (AF) in the Middle East. Consecutive patients with AF presenting to emergency departments (EDs) were prospectively enrolled. Among 1721 patients with nonvalvular AF, mean age was 59 ± 16 years and 44% were women. Comorbidities were common such as hypertension (59%), diabetes (33%), and coronary artery disease (33%). Warfarin was not prescribed to 40% of patients with Congestive heart failure, Hypertension, Age, Diabetes mellitus, Stroke/TIA2 score of ≥2. One-year rates of stroke/transient ischemic attack (TIA) and all-cause mortality were 4.2% and 15.3%, respectively. Warfarin use at hospital-ED discharge was independently associated with lower 1-year rate of stroke/TIA (odds ratio [OR], 0.38; 95% confidence interval [CI], 0.17-0.85; P = .015) and all-cause mortality (OR, 0.51; 95% CI, 0.32-0.83; P = .006). Prior history of heart failure and peripheral vascular disease was independent mortality predictors. Our patients are relatively young with significant cardiovascular risk. Their anticoagulation treatment is suboptimal, and 1-year all-cause mortality and stroke/TIA event rates are relatively high.

  10. Clinical outcome measures of psoriasis.

    PubMed

    Bonifati, C; Berardesca, E

    2007-01-01

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

  11. Early and 1-year outcome and predictors of adverse outcome following monocusp pulmonary valve reconstruction for patients with tetralogy of Fallot: A prospective observational study

    PubMed Central

    Sasikumar, Deepa; Sasidharan, Bijulal; Tharakan, Jaganmohan A; Dharan, Baiju S; Mathew, Thomas; Karunakaran, Jayakumar

    2014-01-01

    Background and Objectives: Repair of tetralogy of Fallot (TOF) with monocusp pulmonary valve reconstruction prevents pulmonary regurgitation (PR) for a variable period. Since postoperative outcome is governed by PR and right ventricular function, we sought to assess the severity of pulmonary regurgitation and right ventricular outflow (RVOT) gradient in the immediate postoperative period and at 1 year and attempted to identify the anatomical substrates responsible for adverse outcomes. Methods: The study included 30 patients. Transthoracic echocardiography was performed before surgery, within 5 days of surgery, and 1 year later. Presence and severity of PR, RVOT gradient, and residual branch pulmonary stenosis were assessed. Right ventricular and monocusp valve functions were studied. Results: Median age was 36.5 months (3-444 months). There were no deaths. Pulmonary regurgitation was mild in 18, moderate in 10, and severe in 2 patients immediately following surgery. At 1 year, 10 patients had severe PR and one had significant RVOT gradient. None of the variables like age, presence of supravalvar pulmonary branch stenosis, main pulmonary artery diameter, or mobility of monocusp valve was found to have any significant association with the progression of PR. McGoon index <1.5 showed a trend toward more PR, while patients with more residual RVOT gradient had lesser regurgitation. Conclusions: Repair of TOF with monocusp pulmonary valve reduces immediate postoperative PR. At 1 year, the monocusp valve underwent loss of function in a significant proportion and PR also progressed. This study could not identify any predictors of progression of PR, though patients with McGoon index <1.5 tended to have more PR while those with more outflow gradient had lesser PR. PMID:24701078

  12. A comparison of outcome of medical and surgical treatment of migraine headache: In 1 year follow-up

    PubMed Central

    Omranifard, Mahmood; Abdali, Hossein; Ardakani, Mehdi Rasti; Talebianfar, Mohsen

    2016-01-01

    Background: This study was designed to compare the efficacy of the medical treatment versus the surgical treatment approach to decompression of trigger point nerves in patients with migraine headaches. Materials and Methods: Fifty volunteers were randomly assigned to the medical treatment group (n = 25) or the surgical treatment group (n = 25) after examination by the team neurologist to ensure a diagnosis of migraine headache. All patients received botulinum toxin type A to confirm the trigger sites. The surgical treatment group underwent surgical deactivation of the trigger site(s). The medical treatment group underwent prophylactic pharmacologic interventions by the neurologist. Pretreatment and 12-month posttreatment migraine headache frequency, duration, and intensity were analyzed and compared to determine the success of the treatments. Results: Nineteen of the 25 patients (76%) in the surgical treatment group and 10 of the 25 patients (40%) in the medical treatment group experienced a successful outcome (at least a 50% decrease in migraine frequency, duration, or intensity) after 1 year from surgery. Surgical treatment had a significantly higher success rate than medical treatment (P < 0.001). Nine patients (36%) in the surgical treatment group and one patient (4%) in the medical treatment group experienced cessation of migraine headaches. The elimination rate was significantly higher in the surgical treatment group than in the medical treatment group (P < 0.001). Conclusions: Based on the 1-year follow-up data, there is strong evidence that surgical manipulation of one or more migraine trigger sites can successfully eliminate or reduce the frequency, duration, and intensity of migraine headaches in a lasting manner. PMID:27563631

  13. Vertebral Augmentation with Nitinol Endoprosthesis: Clinical Experience in 40 Patients with 1-Year Follow-up

    SciTech Connect

    Anselmetti, Giovanni Carlo; Manca, Antonio; Marcia, Stefano; Chiara, Gabriele; Marini, Stefano; Baroud, Gamal; Regge, Daniele; Montemurro, Filippo

    2013-05-08

    PurposeThis study was designed to assess the clinical outcomes of patients treated by vertebral augmentation with nitinol endoprosthesis (VNE) to treat painful vertebral compression fractures.MethodsForty patients with one or more painful osteoporotic VCF, confirmed by MRI and accompanied by back-pain unresponsive to a minimum 2 months of conservative medical treatment, underwent VNE at 42 levels. Preoperative and postoperative pain measured with Visual Analog Scale (VAS), disability measured by Oswestry Disability Index (ODI), and vertebral height restoration (measured with 2-dimensional reconstruction CT) were compared at last follow-up (average follow-up 15 months). Cement extravasation, subsequent fractures, and implant migration were recorded.ResultsLong-term follow-up was obtained in 38 of 40 patients. Both VAS and ODI significantly improved from a median of 8.0 (range 5–10) and 66 % (range 44–88 %) to 0.5 (range 0–8) and 6 % (range 6–66 %), respectively, at 1 year (p < 0.0001). Vertebral height measurements comparing time points increased in a statistically significant manner (ANOVA, p < 0.001). Overall cement extravasation rate was 9.5 %. Discal and venous leakage rates were 7.1 and 0 % respectively. No symptomatic extravasations occurred. Five of 38 (13.1 %) patients experienced new spontaneous, osteoporotic fractures. No device change or migration was observed.ConclusionsVNE is a safe and effective procedure that is able to provide long-lasting pain relief and durable vertebral height gain with a low rate of new fractures and cement leakages.

  14. 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…

  15. Clinical Guidelines and Management of Ankyloglossia with 1-Year Followup: Report of 3 Cases

    PubMed Central

    Bhattad, Mayur S.; Baliga, M. S.; Kriplani, Ritika

    2013-01-01

    The tongue is an important oral structure that affects speech, position of teeth, periodontal tissue, nutrition, swallowing, nursing, and certain social activities. Ankyloglossia (tongue tie) is a congenital anomaly characterized by an abnormally short, thick lingual frenulum which affects movement of tongue. Though the effect of ankyloglossia in general appears to be a minor condition, but a major difference exists concerning the guidelines for tongue-tie division. There are no accepted practical criteria for the management of such condition, and hence this paper aims at bringing all the compilation in examination, diagnosis, treatment, and management of tongue tie together for better clinical approach. PMID:23424685

  16. Outcome of venous stenting following catheter directed thrombolysis for acute proximal lower limb venous thrombosis: a prospective study with venous Doppler follow-up at 1-year.

    PubMed

    Srinivas, B C; Patra, Soumya; Reddy, Babu; Nagesh, C M; Agarwal, Naveen; Manjunath, C N

    2015-10-01

    Functional outcome of venous stent placement for the management of acute iliofemoral deep vein thrombosis (DVT) following catheter-directed thrombolysis (CDT), remain undefined. The purpose of this study was to assess immediate and intermediate term outcomes among patients treated with venous stenting following CDT in patients with proximal lower limb DVT. Thirty consecutive patients aged between 20-70 years with proximal lower limb DVT formed the study group. The mean duration of CDT done with streptokinase was 4.5 ± 1.3 days. Patients with residual venous obstruction and/or large clot burden were treated further with venous angioplasty and/or stenting. Primary endpoint was to evaluate the safety, efficacy and patency of venous stenting in the management of incomplete result following CDT. After 12 months, post-thrombotic syndrome (PTS) was assessed clinically using Villalta scale and deep venous patency was assessed through duplex ultrasound. We studied 8 (5 female and 3 male) patients with 9 (3 left and 6 right) limb involvement and 13 stent (4 balloon expandable and 9 self expandable) placement. All patients improved clinically immediately following venous stenting. Technical success was achieved in all patients. One patient developed pulmonary embolism during course of hospital stay. One patient had stent thrombosis and PTS and another patient died due to carcinoma breast during follow-up. Deep venous stenting is an effective mode of treatment in proximal acute lower limb DVT with high late patency rate up to 1-year.

  17. Quality of Vitamin K Antagonist Control and 1-Year Outcomes in Patients with Atrial Fibrillation: A Global Perspective from the GARFIELD-AF Registry

    PubMed Central

    Haas, Sylvia; ten Cate, Hugo; Accetta, Gabriele; Angchaisuksiri, Pantep; Bassand, Jean-Pierre; Camm, A. John; Corbalan, Ramon; Darius, Harald; Fitzmaurice, David A.; Goldhaber, Samuel Z.; Goto, Shinya; Jacobson, Barry; Kayani, Gloria; Mantovani, Lorenzo G.; Misselwitz, Frank; Pieper, Karen; Schellong, Sebastian M.; Stepinska, Janina; Turpie, Alexander G. G.; van Eickels, Martin; Kakkar, Ajay K.

    2016-01-01

    Aims Vitamin K antagonists (VKAs) need to be individually dosed. International guidelines recommend a target range of international normalised ratio (INR) of 2.0–3.0 for stroke prevention in atrial fibrillation (AF). We analysed the time in this therapeutic range (TTR) of VKA-treated patients with newly diagnosed AF in the ongoing, global, observational registry GARFIELD-AF. Taking TTR as a measure of the quality of patient management, we analysed its relationship with 1-year outcomes, including stroke/systemic embolism (SE), major bleeding, and all-cause mortality. Methods and Results TTR was calculated for 9934 patients using 136,082 INR measurements during 1-year follow-up. The mean TTR was 55.0%; values were similar for different VKAs. 5851 (58.9%) patients had TTR<65%; 4083 (41.1%) TTR≥65%. The proportion of patients with TTR≥65% varied from 16.7% in Asia to 49.4% in Europe. There was a 2.6-fold increase in the risk of stroke/SE, 1.5-fold increase in the risk of major bleeding, and 2.4-fold increase in the risk of all-cause mortality with TTR<65% versus ≥65% after adjusting for potential confounders. The population attributable fraction, i.e. the proportion of events attributable to suboptimal anticoagulation among VKA users, was 47.7% for stroke/SE, 16.7% for major bleeding, and 45.4% for all-cause mortality. In patients with TTR<65%, the risk of first stroke/SE was highest in the first 4 months and decreased thereafter (test for trend, p = 0.021). In these patients, the risk of first major bleed declined during follow-up (p = 0.005), whereas in patients with TTR≥65%, the risk increased over time (p = 0.027). Conclusion A large proportion of patients with AF had poor VKA control and these patients had higher risks of stroke/SE, major bleeding, and all-cause mortality. Our data suggest that there is room for improvement of VKA control in routine clinical practice and that this could substantially reduce adverse outcomes. Trial Registration Clinical

  18. Clinical Performance and Safety of 108 SpineJack Implantations: 1-Year Results of a Prospective Multicentre Single-Arm Registry Study.

    PubMed

    Noriega, David; Maestretti, Gianluca; Renaud, Christian; Francaviglia, Natale; Ould-Slimane, Mourad; Queinnec, Steffen; Ekkerlein, Helmut; Hassel, Frank; Gumpert, Rainer; Sabatier, Pascal; Huet, Hervé; Plasencia, Miguel; Theumann, Nicolas; Kunsky, Alexander; Krüger, Antonio

    2015-01-01

    This prospective, consecutive, multicentre observational registry aimed to confirm the safety and clinical performance of the SpineJack system for the treatment of vertebral compression fractures (VCF) of traumatic origin. We enrolled 103 patients (median age: 61.6 years) with 108 VCF due to trauma, or traumatic VCF with associated osteoporosis. Primary outcome was back pain intensity (VAS). Secondary outcomes were Oswestry Disability Index (ODI), EuroQol-VAS, and analgesic consumption. 48 hours after surgery, a median relative decrease in pain intensity of 81.5% was observed associated with a significant reduction in analgesic intake. Improvements in disability (91.3% decrease in ODI score) and in quality of life (increase 21.1% of EQ-VAS score) were obtained 3 months after surgery. All results were maintained at 12 months. A reduction in the kyphotic angulation was observed postoperatively (-5.4 ± 6.3°; p < 0.001), remained at 12 months (-4.4 ± 6.0°, p = 0.002). No adverse events were implant-related and none required device removal. Three patients (2.9%) experienced procedure-related complications. The overall adjacent fracture rate up to 1 year after surgery was 2.9%. The SpineJack procedure is an effective, low-risk procedure for patients with traumatic VCF allowing a fast and sustained improvement in quality of life over 1 year after surgery.

  19. Clinical Performance and Safety of 108 SpineJack Implantations: 1-Year Results of a Prospective Multicentre Single-Arm Registry Study

    PubMed Central

    Noriega, David; Maestretti, Gianluca; Renaud, Christian; Francaviglia, Natale; Ould-Slimane, Mourad; Queinnec, Steffen; Ekkerlein, Helmut; Hassel, Frank; Gumpert, Rainer; Sabatier, Pascal; Huet, Hervé; Plasencia, Miguel; Theumann, Nicolas; Kunsky, Alexander; Krüger, Antonio

    2015-01-01

    This prospective, consecutive, multicentre observational registry aimed to confirm the safety and clinical performance of the SpineJack system for the treatment of vertebral compression fractures (VCF) of traumatic origin. We enrolled 103 patients (median age: 61.6 years) with 108 VCF due to trauma, or traumatic VCF with associated osteoporosis. Primary outcome was back pain intensity (VAS). Secondary outcomes were Oswestry Disability Index (ODI), EuroQol-VAS, and analgesic consumption. 48 hours after surgery, a median relative decrease in pain intensity of 81.5% was observed associated with a significant reduction in analgesic intake. Improvements in disability (91.3% decrease in ODI score) and in quality of life (increase 21.1% of EQ-VAS score) were obtained 3 months after surgery. All results were maintained at 12 months. A reduction in the kyphotic angulation was observed postoperatively (−5.4 ± 6.3°; p < 0.001), remained at 12 months (−4.4 ± 6.0°, p = 0.002). No adverse events were implant-related and none required device removal. Three patients (2.9%) experienced procedure-related complications. The overall adjacent fracture rate up to 1 year after surgery was 2.9%. The SpineJack procedure is an effective, low-risk procedure for patients with traumatic VCF allowing a fast and sustained improvement in quality of life over 1 year after surgery. PMID:26844224

  20. Connectedness to the criminal community and the community at large predicts 1-year post-release outcomes among felony offenders

    PubMed Central

    Folk, Johanna B.; Mashek, Debra; Tangney, June; Stuewig, Jeffrey; Moore, Kelly E.

    2016-01-01

    Connectedness to one's community relates to positive psychological and behavioral outcomes. But what implications do connectedness to distinct communities—the criminal community and the community at large—have for inmates about to be released from jail? This study (N = 383) prospectively examined connectedness to the criminal community and community at large prior to release from jail, and functioning at one-year post-release. Connectedness to the community at large positively predicted community adjustment whereas connectedness to the criminal community positively predicted recidivism. Targeting both types of community connectedness may enhance interventions intended to undermine recidivism and increase positive outcomes for inmates. PMID:27524842

  1. Connectedness to the criminal community and the community at large predicts 1-year post-release outcomes among felony offenders.

    PubMed

    Folk, Johanna B; Mashek, Debra; Tangney, June; Stuewig, Jeffrey; Moore, Kelly E

    2016-04-01

    Connectedness to one's community relates to positive psychological and behavioral outcomes. But what implications do connectedness to distinct communities-the criminal community and the community at large-have for inmates about to be released from jail? This study (N = 383) prospectively examined connectedness to the criminal community and community at large prior to release from jail, and functioning at one-year post-release. Connectedness to the community at large positively predicted community adjustment whereas connectedness to the criminal community positively predicted recidivism. Targeting both types of community connectedness may enhance interventions intended to undermine recidivism and increase positive outcomes for inmates.

  2. Use of the AngioSculpt scoring balloon for infrapopliteal lesions in patients with critical limb ischemia: 1-year outcome.

    PubMed

    Bosiers, Marc; Deloose, Koen; Cagiannos, Catherine; Verbist, Jürgen; Peeters, Patrick

    2009-01-01

    The AngioSculpt Scoring Balloon Catheter (AngioScore, Inc., Fremont, CA) is composed of a semicompliant balloon encircled by three nitinol spiral struts providing targeted lesion scoring on balloon inflation. Between April 2005 and April 2006, procedural and follow-up data on 31 patients (mean age 76 years; 54.8% males) endovascularly treated for severe infrapopliteal disease were collected. The AngioSculpt catheter was used to treat 36 complex, tibioperoneal, atherosclerotic lesions. All patients had symptomatic critical limb ischemia (Rutherford 4-5) and single-vessel runoff to the ankle. Complication-free survival at 1 month was the safety end point, whereas primary patency and limb salvage were the efficacy end points evaluated at 1 year. The AngioSculpt balloon was successfully inflated in all 36 target lesions. Eleven patients (35.5%) required additional stenting for minor dissections or suboptimal stenosis reduction. The 1-month complication-free survival was 96.8%. One-year survival, primary patency, and limb salvage rates were 83.9 +/- 6.6%, 61.0 +/- 9.3%, and 86.3 +/- 6.4%, respectively. The 1-year data show the AngioSculpt Scoring Balloon Catheter to be an effective and safe treatment for infrapopliteal, atherosclerotic lesions in patients with critical limb ischemia. However, more patients, a longer follow-up, and randomized studies comparing it with conventional balloon angioplasty and stenting in the infrapopliteal region are required.

  3. Improving the Health of People with Intellectual Disabilities: Outcomes of a Health Screening Programme after 1 Year

    ERIC Educational Resources Information Center

    Cooper, S. A.; Morrison, J.; Melville, C.; Finlayson, J.; Allan, L.; Martin, G.; Robinson, N.

    2006-01-01

    Background: People with intellectual disabilities (IDs) have a higher level of health needs, a higher level of which is unmet, compared with the general population. Health screening can detect unmet health needs, but it is unknown whether it effects beneficial health outcomes in the longer term. People with IDs are reliant on health management by…

  4. Change in attachment insecurity is related to improved outcomes 1-year post group therapy in women with binge eating disorder.

    PubMed

    Maxwell, Hilary; Tasca, Giorgio A; Ritchie, Kerri; Balfour, Louise; Bissada, Hany

    2014-03-01

    An interpersonal model of Binge Eating Disorder (BED) posits that difficulties with social functioning precipitate negative affect, which in turn causes binge eating as a means of coping. Thus, long-term decreases in attachment insecurity may be important for women with BED. No research has assessed if long-term change in attachment insecurity is associated with sustained change in other outcomes. In the current study, we hypothesized that changes in attachment anxiety and avoidance will decrease at posttreatment and will be maintained up to 12 months after Group Psychodynamic Interpersonal Psychotherapy (GPIP). We further hypothesized that long-term stability of these changes in attachment insecurity will be related to other long-term outcomes. Women with BED (N = 102) attended 16 sessions of GPIP. Measures were completed pretreatment, posttreatment, at 6 and 12 months follow-up. Attachment anxiety, attachment avoidance, and the other outcome variables decreased significantly at 12 months posttreatment. Reductions in attachment anxiety and avoidance were significantly related to decreases in interpersonal problems up to 12 months posttreatment, and reduction in attachment anxiety was significantly related to decreases in depressive symptoms 12 months posttreatment. Further, the significant relationship between reduced attachment avoidance and decreased interpersonal problems strengthened over the long term. This is the first study to show an association between change in attachment insecurity and change in other outcomes in the long term, and to show an adaptive spiral in which greater reduction in attachment avoidance is increasingly associated with ongoing improvement of interpersonal problems.

  5. Attribution in somatizers: stability and relationship to outcome at 1-year follow-up. Grupo Morbilidad Psiquica y Psicosomática de Zaragoza (GMPPZ).

    PubMed

    García-Campayo, J; Larrubia, J; Lobo, A; Pérez-Echeverría, M J; Campos, R

    1997-05-01

    The aim of this study was to determine whether attributional style is a stable pattern in somatizers, to analyse the sociodemographic and psychopathological characteristics that can modify it, and to study the relationship between attributional pattern and outcome. A total of 147 somatizers and 46 psychologizers from a representative sample (n = 1559) of primary care patients in Zaragoza, Spain were followed up for 1 year. Attribution of somatic symptoms was a stable construct in somatizers. Patients who modified attribution were younger (by 15 years on average), tended to be without a partner, and had a shorter illness duration (by 20 months on average) than those who maintained it. Attribution showed no correlation with outcome at the 1-year follow-up.

  6. 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.

  7. Treatment Seeking and Subsequent 1-Year Drinking Outcomes among Treatment Clients in Sweden and the U.S.A.: A Cross-Cultural Comparison

    PubMed Central

    Romelsjö, Anders

    2012-01-01

    Cross-cultural comparisons provide method for distinguishing unique aspects as well as shared aspects of different cultures. Theoretically framed by a health-services conceptual model, we examine the extent that culture-specific versus common characteristics are associated with treatment seeking and drinking outcome. Swedish (n=997) and U.S. (n=501) alcohol-dependent individuals were interviewed at baseline and 1-year (n=635 & n=384 respectively). Both studies gathered comparable background, help-seeking, and drinking data. Regression models tested predictors of 1-year follow-up drinking defined as abstinence or moderate drinking versus heavy drinking. Swedish individuals were older and had social networks comprised of mostly substance abusers compared to U.S. individuals who reported higher problem severity and greater drug involvement. Whereas U.S. individuals reported greater prior mutual-help attendance, Swedish individuals reported greater prior treatment involvement. Better 1-year drinking outcomes were reported by women, younger age groups and those with an abstinence goal in both samples. Cultural and institutional differences were apparent. For example, with Swedish individuals having a mostly non-using network predicted better outcomes, whereas lower problem severity was a predictor for U.S. individuals. PMID:22673154

  8. "I was born full deaf." Written language outcomes after 1 year of strategic and interactive writing instruction.

    PubMed

    Wolbers, Kimberly A; Dostal, Hannah M; Bowers, Lisa M

    2012-01-01

    Nonstandard grammatical forms are often present in the writing of deaf students that are rarely, if ever, seen in the writing of hearing students. With the implementation of Strategic and Interactive Writing Instruction (SIWI) in previous studies, students have demonstrated significant gains in high-level writing skills (e.g., text structure) but have also made gains with English grammar skills. This 1-year study expands on prior research by longitudinally examining the written language growth (i.e., writing length, sentence complexity, sentence awareness, and function words) of 29 deaf middle-school students. A repeated-measures analysis of variance with a between-subjects variable for literacy achievement level was used to examine gains over time and the intervention's efficacy when used with students of various literacy levels. Students, whether high or low achieving, demonstrated statistically significant gains with writing length, sentence complexity, and sentence awareness. Subordinate clauses were found to be an area of difficulty, and follow up strategies are suggested. An analysis of function word data, specifically prepositions and articles, revealed different patterns of written language growth by language group (e.g., American Sign Language users, oral students, users of English-based sign).

  9. Assessing depression outcomes in group practice clinics.

    PubMed Central

    Braswell, H R; Williamson, J W

    1979-01-01

    The application of a protocol for the initial assessment of medical care outcomes of geriatric depression management in four multispecialty group practice clinics is described. The clinical findings of this study are limited, but the protocol for the assessment of depression outcomes was found to be feasible, practical and acceptable in all four clinics. The success of the study has positive implications both for improving management of depressed clinic patients and for adapting this quality assurance approach to other health conditions and care settings. PMID:507262

  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.

  11. 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

  12. Longitudinal changes in prospective memory and their clinical correlates at 1-year follow-up in first-episode schizophrenia

    PubMed Central

    Ungvari, Gabor S.; Ng, Chee H.; Zhou, Yan; Zhang, Liang; Zhou, Jingjing; Shum, David H. K.; Man, David; Liu, Deng-Tang; Li, Jun; Xiang, Yu-Tao

    2017-01-01

    This study aimed to investigate prospective memory (PM) and the association with clinical factors at 1-year follow-up in first-episode schizophrenia (FES). Thirty-two FES patients recruited from a university-affiliated psychiatric hospital in Beijing and 17 healthy community controls (HCs) were included. Time- and event-based PM (TBPM and EBPM) performances were measured with the Chinese version of the Cambridge Prospective Memory Test (C-CAMPROMPT) at baseline and at one-year follow-up. A number of other neurocognitive tests were also administered. Remission was determined at the endpoint according to the PANSS score ≤ 3 for selected items. Repeated measures analysis of variance revealed a significant interaction between time (baseline vs. endpoint) and group (FES vs. HCs) for EBPM (F(1, 44) = 8.8, p = 0.005) and for all neurocognitive components. Paired samples t-tests showed significant improvement in EBPM in FES (13.1±3.7 vs. 10.3±4.8; t = 3.065, p = 0.004), compared to HCs (15.7±3.6 vs. 16.5±2.3; t = -1.248, p = 0.230). A remission rate of 59.4% was found in the FES group. Analysis of covariance revealed that remitters performed significantly better on EBPM (14.9±2.6 vs. 10.4±3.6; F(1, 25) = 12.2, p = 0.002) than non-remitters at study endpoint. The association between EBPM and 12-month clinical improvement in FES suggests that EBPM may be a potential neurocognitive marker for the effectiveness of standard pharmacotherapy. Furthermore, the findings also imply that PM may not be strictly a trait-related endophenotype as indicated in previous studies. PMID:28245266

  13. Liposomal bupivacaine and clinical outcomes.

    PubMed

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

    2014-03-01

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

  14. Clinical and Serum-Based Markers Are Associated with Death within 1 year of de novo Implant in Primary Prevention ICD Recipients

    PubMed Central

    Zhang, Yiyi; Guallar, Eliseo; Blasco-Colmenares, Elena; Dalal, Darshan; Butcher, Barbara; Norgard, Sanaz; Tjong, Fleur V. Y.; Eldadah, Zayd; Dickfeld, Timm; Ellenbogen, Kenneth A.; Marine, Joseph E.; Tomaselli, Gordon F.; Cheng, Alan

    2014-01-01

    Background Implantable cardioverter defibrillator (ICD) implantation is contraindicated in those with <1 year life expectancy. Objective To develop a risk prediction score for 1-year mortality in patients with primary prevention ICDs and to determine the incremental improvement in discrimination when incorporating serum-based biomarkers to traditional clinical variables. Methods We analyzed data from the PROSE-ICD study, a large prospective observational study of patients undergoing primary prevention ICD implantation who were extensively phenotyped for clinical and serum markers. We identified variables predicting 1-year mortality and synthesized them into a comprehensive risk scoring construct using backward selection. Results Among 1,189 patients deemed by their treating physicians as having reasonable 1 year life expectancy, 62 patients died within 1 year of ICD implantation. The risk score, comprised of 6 clinical factors (age ≥75 years, New York Heart Association class III/IV, atrial fibrillation, eGFR <30mL/min/1.73m2, diabetes, and use of diuretics), had good discrimination (AUC=0.77) for 1-year mortality. Addition of 3 biomarkers (TNF-αRII, pro-BNP, and cTnT) further improved model discrimination to 0.82. Patients with 0-1, 2-3, 4-6, or 7-9 risk factors had 1-year mortality rates of 0.8%, 2.7%, 16.1% and 46.2%, respectively. Conclusions Individuals with more co-morbidities and elevations of specific serum biomarkers were at increased risk for all-cause mortality despite being deemed as having reasonable 1 year life expectancy. A simple risk score comprised of readily available clinical data and serum biomarkers may better identify patients at high risk of early mortality and improve patient selection and counseling for primary prevention ICD therapy. PMID:25446153

  15. 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."

  16. Clinical and imaging predictors of 1-year and long-term mortality in light chain (AL) amyloidosis: a 5-year follow-up study.

    PubMed

    Migrino, Raymond Q; Harmann, Leanne; Christenson, Richard; Hari, Parameswaran

    2014-11-01

    Light chain amyloidosis (AL) involves multiorgan failure induced by amyloidogenic light chain proteins, and is associated with high mortality. We aimed to identify clinical, laboratory, and imaging parameters that would predict 1-year and long-term AL mortality. Forty-four biopsy-proven AL patients (61.5 ± 12 years, 20 females) underwent clinical evaluation including laboratory assays, echocardiography, and contrast cardiac magnetic resonance imaging (CMR, n = 31) prior to chemotherapy. Patients were prospectively followed for median duration of 62.7 months (interquartile range 35.5 months). Clinical and laboratory parameters were compared between 1-year survivors and nonsurvivors. Univariate Kaplan-Meier survival plots were calculated followed by stepwise logistic regression analysis to assess independent predictors of long-term survival. Eighteen (40.9 %) patients died within 1 year and an additional 10 subjects died during long-term follow-up. Patients who expired within 1 year presented with more advanced class of heart failure, higher alkaline phosphatase and uric acid, lower limb lead voltage on electrocardiography, shorter left ventricular ejection time (ET) on echocardiography, and a higher proportion of late gadolinium enhancement on CMR. On multivariable analysis, only ET ≤240 ms on echocardiography (hazard ratio (HR) 5.07, 95 % confidence interval (CI) 1.83-14.1, P = 0.002) and New York Heart Association functional class II-IV presentation (HR 1.0058, 95 % CI 1.0014-1.0103, P = 0.01) were independent predictors of AL mortality. In conclusion, AL amyloidosis is associated with high 1-year and long-term mortality. Among clinical, laboratory, and imaging parameters tested, an echocardiographic finding of ET ≤240 ms has independent and additive prognostic value to clinical heart failure evaluation in determining long-term survival of AL patients. This result may be important in the early identification of patients at risk.

  17. Clinical outcomes following osteochondral autologous transplantation (OATS).

    PubMed

    Lahav, Amit; Burks, Robert T; Greis, Patrick E; Chapman, Andrew W; Ford, Gregory M; Fink, Barbara P

    2006-07-01

    This study evaluated the clinical outcome in 21 patients (22 knees) undergoing osteochondral autologous transplantation (OATS) in the knee over a 5-year period. Sixteen knees in 15 patients were available for follow-up at an average of 40 months after the procedure. The clinical outcome was analyzed using the IKDC and Knee and Osteoarthritis Outcome Score (KOOS) evaluation forms, a subjective questionnaire, and a clinical examination. At final follow-up, the average KOOS result for pain was 80.6 (range: 56-94), symptoms 53.6 (range: 25-71), function of activities of daily living 93.4 (range: 79-100), function of sports and recreational activities 65.3 (range: 20-100), and quality of life 51.0 (range: 6-88). The average IKDC score was 68.2. On our subjective questionnaire, the average preoperative grade given was 3.1 (range: 1-7) with an improvement at the most recent follow-up to a grade of 8.0 (range: 5-10) (P < .00001). Thirteen (86%) patients reported that they would have the surgery again if they had to make the decision a second time. Age did not correlate with subjective results on the IKDC evaluation (P = .7048) or score difference on our questionnaire (P = .9175). This procedure provides an option for articular resurfacing of the femoral condyles for focal areas of chondral defects with promising results regarding subjective improvement.

  18. 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

  19. Clinical outcome measures in juvenile idiopathic arthritis.

    PubMed

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

    2016-04-18

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

  20. Vitamin D and Clinical Outcomes in Dialysis

    PubMed Central

    Parikh, Coral; Gutgarts, Victoria; Eisenberg, Elliot; Melamed, Michal L.

    2016-01-01

    Most dialysis patients are vitamin D deficient, including deficiencies in both activated vitamin D (1, 25-dihydroxyvitamin D) and the less active 25-hydroxyvitamin D. These and other abnormalities associated with chronic kidney disease (CKD), if they remain untreated, lead to secondary hyperparathyroidism and bone changes, such as osteitis fibrosa cystica. Activated vitamin D has been proven to decrease parathyroid hormone (PTH) levels in dialysis patients and is currently used for this indication. There are multiple other potential “pleotrophic” effects associated with vitamin D therapy. These include associations with lower all-cause and cardiovascular mortality, lower rates of infections and improved glycemic indexes. Meta-analyses of multiple observational studies have shown activated vitamin D therapy to be associated with improved survival. Observational data also suggest fewer infections and better glucose control. There have been no randomized clinical trials powered to evaluate mortality or other clinical outcomes. Small trials of nutritional vitamin D (ergocalciferol and cholecalciferol) showed increases in 25-hydroxyvitamin D levels without hypercalcemia or hyperphosphatemia, even when given in addition to activated vitamin D therapy. While activated vitamin D therapy is associated with improved outcomes, it also leads to higher fibroblast growth factor 23 (FGF-23) levels, which may be detrimental in dialysis patients. Further research is needed to evaluate whether activated or nutritional vitamin D therapy are beneficial in dialysis patients for outcomes other than secondary hyperparathyroidism. PMID:26424141

  1. Clinical performance of a resin-modified glass-ionomer and two polyacid-modified resin composites in cervical lesions restorations: 1-year follow-up.

    PubMed

    Chinelatti, M A; Ramos, R P; Chimello, D T; Palma-Dibb, R G

    2004-03-01

    The aim of this study was to assess the clinical performance of a resin-modified glass-ionomer cement (Vitremer) and two polyacid-modified resin composites (F2000 and Freedom) over 1 year. Nineteen patients with at least three cervical lesions were selected, providing an initial sample size of 87 restorations (29 per material), being 78 to non-carious and nine to carious lesions. Restorations were evaluated at baseline, 6 months and 1 year after placement, using modified US Public Health Service criteria: colour match, marginal discoloration, caries, anatomical form, marginal integrity and surface texture. At baseline, restorations were considered as acceptable for all criteria. At 1-year recall, 21 restorations per material were re-examined. Freedom was rated Bravo or Charlie for all the examined criteria and Vitremer earned an Alfa rating solely for the criterion caries. On the contrary, F2000 showed the best overall results, although presenting significant alteration in colour match. Statistical analysis of data was performed using chi-square and Mc Nemar tests. As to the evaluated periods, significant difference was observed solely between baseline and 1-year recall. Freedom and Vitremer were statistically different (P < 0.01) as to anatomical form and surface texture. For F2000, significant difference (P < 0.05) was noticed as to colour match and anatomical form. After 1-year follow-up, F2000 showed the most acceptable results as to the analysed criteria.

  2. 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

  3. Patients' characteristics and clinical implications of suboptimal CD4 T-cell gains after 1 year of successful antiretroviral therapy.

    PubMed

    Gutiérrez, Félix; Padilla, Sergio; Masiá, Mar; Iribarren, José A; Moreno, Santiago; Viciana, Pompeyo; Hernández-Quero, José; Alemán, Remedios; Vidal, Francesc; Salavert, Miguel; Blanco, José R; Leal, Manuel; Dronda, Fernando; Perez Hoyos, Santiago; del Amo, Julia

    2008-03-01

    To describe characteristics and prognosis of patients with suboptimal immunological response to combined antiretroviral therapy (CART). Using data from a multicenter cohort study, we selected patients who initiated CART and showed suboptimal CD4-T cell response (defined as <50 cells/L increase) after 1 year of therapy, despite sustained virological suppression. Characteristics of those patients were compared with subjects who showed optimal immunological response. Of 650 patients with virological suppression, 108 (16.6%) showed suboptimal CD4-T cell response. Independent predictors of suboptimal response were previous injection drug use (OR, 1.85; 95% CI, 1.12-2.98) and age at CART initiation (OR, 1.04 per year increase; 95%CI, 1.01-1.06). Hepatitis C virus coinfection was not associated with impaired immunological response. As compared with patients with optimal immunological response, those with suboptimal response had a higher mortality rate (3.22 versus 0.71 per 100 person-years; p=.001), but a similar rate of new AIDS-defining events. In patients with sustained virological suppression with CART, previous injection drug use, but not hepatitis C virus coinfection, and older age at initiation of therapy were associated with suboptimal CD4 T-cell responses. Patients with suboptimal response had a higher mortality over time, mainly due to diseases other than AIDS-defining events.

  4. Clinical Outcomes Following Revision Anterior Shoulder Stabilization

    PubMed Central

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

    2015-01-01

    Objectives: The purpose of this study was to determine the clinical outcomes following revision anterior shoulder stabilization performed either via all-arthroscopic soft tissue repair or via Latarjet coracoid transfer. Methods: A retrospective review of prospectively collected data on 91 shoulders undergoing revision anterior shoulder stabilization was performed. All patients underwent prior soft tissue stabilization; those with prior open bone grafting procedures were excluded. For patients with 25% glenoid bone loss, Latarjet was performed (n=28). Patients were queried regarding recurrent instability (subluxation or dislocation). Clinical outcomes were evaluated using validated patient reported outcome questionnaires including the American Shoulder and Elbow Surgeons (ASES) score, Simple Shoulder Test (SST), visual analog scale (VAS) for pain, and Western Ontario Shoulder Instability Index (WOSI). Results: A total of 63 shoulders in 62 patients (46 males, 16 females) with an average age of 23.2 ± 6.9 years were included in the revision arthroscopy group. At an average follow-up of 46.9 ± 16.8 months (range, 15 to 78), the mean WOSI score was 80.1 (range, 15.0 to 100), and there were significant improvements (p<0.001) in ASES (63.7 to 85.1), SST (6.2 to 9.1), and VAS pain scores (2.89 to 0.81). Recurrent instability occurred in 12 of 63 shoulders (19%); the number of prior surgeries and baseline hyperlaxity were significant risk factors for failure (p<0.001 and p=0.04, respectively). No patients developed clinical or radiographic evidence of arthritis. A total of 28 shoulders in 28 patients (21 male, 7 female) with an average age of 27.5 years (range 14 to 45) were included in the Latarjet group. Thirteen (46%) had more than one previous stabilization attempt. ), the average WOSI score was 71.9, and there were significant improvements (p<0.001) in ASES (65.7 to 87.0), SST (7.2 to 10.3), and VAS (3.1 to 1.1). Recurrent instability occurred in 2 of 28 shoulders

  5. 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.

  6. 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

  7. The clinical outcome of childhood masturbation.

    PubMed

    Unal, F

    2000-01-01

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

  8. Clinical Features and Outcome of Mucormycosis

    PubMed Central

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

    2014-01-01

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

  9. 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.

  10. Controlled outcome studies of child clinical hypnosis.

    PubMed

    Adinolfi, Barbara; Gava, Nicoletta

    2013-09-01

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

  11. Cinacalcet and Clinical Outcomes in Dialysis.

    PubMed

    Komaba, Hirotaka; Fukagawa, Masafumi

    2015-01-01

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

  12. Comparison of weight loss outcomes 1 year after sleeve gastrectomy and Roux-en-Y gastric bypass in patients aged above 50 years

    PubMed Central

    Praveenraj, Palanivelu; Gomes, Rachel M; Kumar, Saravana; Perumal, Sivalingam; Senthilnathan, Palanisamy; Parthasarathi, Ramakrishnan; Rajapandian, Subbiah; Palanivelu, Chinnusamy

    2016-01-01

    INTRODUCTION: Safe, effective weight loss with resolution of comorbidities has been convincingly demonstrated with bariatric surgery in the aged obese. They, however, lose less weight than younger individuals. It is not known if degree of weight loss is influenced by the choice of bariatric procedure. The aim of this study was to compare the degree of weight loss between laparoscopic sleeve gastrectomy (LSG) and laparoscopic Roux-en-Y gastric bypass (LRYGB) in patients above the age of 50 years at 1 year after surgery. MATERIALS AND METHODS: A retrospective analysis was performed of all patients more than 50 years of age who underwent LSG or LRYGB between February 2012 and July 2013 with at least 1 year of follow-up. Data evaluated at 1 year included age, sex, weight, body mass index (BMI), mean operative time, percentage of weight loss and excess weight loss, resolution/remission of diabetes, morbidity and mortality. RESULTS: Of a total of 86 patients, 54 underwent LSG and 32 underwent LRYGB. The mean percentage of excess weight loss at the end of 1 year was 60.19 ± 17.45 % after LSG and 82.76 ± 34.26 % after LRYGB (P = 0.021). One patient developed a sleeve leak after LSG, and 2 developed iron deficiency anaemia after LRYGB. The remission/improvement in diabetes mellitus and biochemistry was similar. CONCLUSION: LRYGB may offer better results than LSG in terms of weight loss in patients over 50 years of age. PMID:27279392

  13. Consultation-Based Academic Interventions for Children with Attention Deficit Hyperactivity Disorder: Effects on Reading and Mathematics Outcomes at 1-Year Follow-Up

    ERIC Educational Resources Information Center

    Volpe, Robert J.; DuPaul, George J.; Jitendra, Asha K.; Tresco, Katy E.

    2009-01-01

    The purpose of this follow-up study was to evaluate the effectiveness of two consultation-based models to enhance the educational functioning of children with attention deficit hyperactivity disorder (ADHD) after 1 year of no treatment. Children (N = 167) meeting "Diagnostic Statistical Manual" (4th ed., text revision; 2000) criteria for attention…

  14. Esthetic outcomes in relation to implant-abutment interface design following a standardized treatment protocol in a multicenter randomized controlled trial--a cohort of 12 cases at 1-year follow-up.

    PubMed

    McGuire, Michael K; Scheyer, Todd; Ho, Daniel K; Stanford, Clark M; Feine, Jocelyne S; Cooper, Lyndon F

    2015-01-01

    The design of an implant-abutment interface may have an impact on the peri-implant soft tissue esthetics. In an ongoing randomized controlled trial (RCT) with 141 participants, the authors evaluated the peri-implant tissue responses around three different implant-abutment interface designs used to replace single teeth in the esthetic zone. The aim of this report is to describe the treatment protocol utilized in this ongoing RCT by (1) demonstrating in detail a clinical case treated under this protocol and (2) reporting peri-implant soft tissue responses in a cohort of 12 representative cases from the RCT at 1-year follow-up. Male and female adults requiring single implants in the anterior maxilla were enrolled in the RCT according to the study protocol. Five months following any required extraction and/or socket bone grafting/ridge augmentation, one of the following three implant-abutment interfaces was placed and immediately provisionalized: (1) conical interface (CI; OsseoSpeed, Dentsply Implants), n = 4; (2) flat-to-flat interface (FI; NobelSpeedy Replace, Nobel Biocare), n = 4; or (3) platform-switch interface (PS; NanoTite Certain Prevail, Biomet 3i), n = 4. Twelve weeks later, definitive crowns were delivered. Throughout the treatment, peri-implant buccal gingival zenith height and mesial/distal papilla height were measured on stereotactic device photographs, and pink esthetic scores (PES) were determined. The demographics of the participants in each of the three implant-abutment interface groups were very similar. All 12 study sites had ideal ridge form with a minimum width of 5.5 mm following implant site development performed according to the described treatment protocol. Using this treatment protocol for single-tooth replacement in the anterior maxilla, the clinicians were able to obtain esthetic peri-implant soft tissue outcomes with all three types of implant-abutment interface designs at 1-year follow-up as shown by the Canfield data and PES. The

  15. The primary outcome measure and its importance in clinical trials.

    PubMed

    Andrade, Chittaranjan

    2015-10-01

    The primary outcome measure is the outcome that an investigator considers to be the most important among the many outcomes that are to be examined in the study. The primary outcome needs to be defined at the time the study is designed. There are 2 reasons for this: it reduces the risk of false-positive errors resulting from the statistical testing of many outcomes, and it reduces the risk of a false-negative error by providing the basis for the estimation of the sample size necessary for an adequately powered study. This article discusses the setting of the primary outcome measure, the need for it, the increased risk of false-positive and false-negative errors in secondary outcome results, how to regard articles that do not state the primary outcome, how to interpret results when secondary outcomes are statistically significant but not the primary outcome, and limitations of the concept of a primary outcome measure in clinical trial research.

  16. Positive effect of mushrooms substituted for meat on body weight, body composition, and health parameters. A 1-year randomized clinical trial.

    PubMed

    Poddar, Kavita H; Ames, Meghan; Hsin-Jen, Chen; Feeney, Mary Jo; Wang, Youfa; Cheskin, Lawrence J

    2013-12-01

    Reducing energy density (ED) of the diet is an important strategy for controlling obesity. This 1-year, randomized clinical trial examined the effect of substituting mushrooms for red meat ('mushroom diet'), compared to a standard diet ('meat diet'), on weight loss and maintenance among 73 obese adults (64 women, 9 men). The subjects completed anthropometric measurements and 7-day food records four times during a standardized weight loss and maintenance regimen. At the end of the 1-year trial, compared to participants on the standard diet, participants on the mushroom diet (n=36) reported lower intakes of energy (mean ± [SE]=-123 ± 113 kcals) and fat (-4.25 ± 6.88 g), lost more pounds and percentage body weight (-7.03 ± 3.34 lbs, 3.6%), achieved lower body mass index (-1.53 ± 0.36), waist circumference (-2.6 ± 3.5 in.) and percent total body fat (-0.85 ± 0.53), and had lower systolic and diastolic pressure (-7.9 and -2.5 mmHg); their lipid profile and inflammatory markers also improved. After initial weight loss, subjects following the mushroom diet maintained that loss well. Those who completed the full 12-month trial still weighed a mean of 7 lbs less than baseline. Thus, encouraging adults to substitute mushrooms for red meat was a useful strategy for enhancing weight loss, weight maintenance, and health parameters.

  17. Dual chamber rate responsive pacing system driven by contractility: final assessment after 1-year follow-up. The European PEA Clinical Investigation Group.

    PubMed

    Clémenty, J

    1998-11-01

    The aim of this study was to assess the long-term performance of a new dual chamber rate responsive pacing system based on the dynamic measurement of the peak endocardial acceleration (PEA) index of cardiac contractility. Seventy patients who participated in the Multicenter European Clinical Evaluation were studied 1 year after implantation by continuously recording the PEA and the heart rate (HR) during exercise stress testing and during 24 hours of usual activities. A complete examination of standard parameters was also performed to assess the pacing/sensing lead characteristics. Statistical comparisons were performed with the data recorded with the same protocol at 1 month after implant for each patient. A linear correlation coefficient was calculated between PEA and sinus rate when the patient showed predominant atrial tracked rhythm. There were no significant differences between PEA values measured at 1 month and 1 year (PEA = 0.41 +/- 0.26 g vs 0.45 +/- 0.29 g at rest and PEA = 1.63 +/- 0.77 g vs 1.72 +/- 0.83 g during peak exercise). The correlation coefficient remained stable (0.67 +/- 0.15 vs 0.65 +/- 0.14 during daily life and 0.74 +/- 0.14 vs 0.77 +/- 0.11 during exercise). The PEA signal detected by the sensor was reliable and stable. No long-term complications or adverse effects were observed, and the lead performance was comparable to that of a standard lead.

  18. 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.

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

    PubMed

    Mochtar, I; Al-Monjed, M F

    2015-06-09

    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.

  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. Long-term clinical outcome of neonatal EEG findings.

    PubMed

    Almubarak, Salah; Wong, Peter K H

    2011-04-01

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

  2. Cognitive Impairment after Severe Traumatic Brain Injury, Clinical Course and Impact on Outcome: A Swedish-Icelandic Study

    PubMed Central

    Stenberg, Maud; Godbolt, Alison K.; Nygren De Boussard, Catharina; Levi, Richard; Stålnacke, Britt-Marie

    2015-01-01

    Objective. To assess the clinical course of cognitive and emotional impairments in patients with severe TBI (sTBI) from 3 weeks to 1 year after trauma and to study associations with outcomes at 1 year. Methods. Prospective, multicenter, observational study of sTBI in Sweden and Iceland. Patients aged 18–65 years with acute Glasgow Coma Scale 3–8 were assessed with the Barrow Neurological Institute Screen for Higher Cerebral Functions (BNIS) and the Hospital Anxiety and Depression Scale (HADS). Outcome measures were Glasgow Outcome Scale Extended (GOSE) and Rancho Los Amigos Cognitive Scale-Revised (RLAS-R). Results. Cognition was assessed with the BNIS assessed for 42 patients out of 100 at 3 weeks, 75 patients at 3 months, and 78 patients at 1 year. Cognition improved over time, especially from 3 weeks to 3 months. The BNIS subscales “orientation” and “visuospatial and visual problem solving” were associated with the GOSE and RLAS-R at 1 year. Conclusion. Cognition seemed to improve over time after sTBI and appeared to be rather stable from 3 months to 1 year. Since cognitive function was associated with outcomes, these results indicate that early screening of cognitive function could be of importance for rehabilitation planning in a clinical setting. PMID:26783381

  3. 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.

  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. Spouse-assisted training in pain coping skills and the outcome of multidisciplinary pain management for chronic low back pain treatment: a 1-year randomized controlled trial.

    PubMed

    Abbasi, M; Dehghani, M; Keefe, F J; Jafari, H; Behtash, H; Shams, J

    2012-08-01

    This study examined the comparative efficacy of three interventions: a spouse-assisted coping skills training protocol for patients undergoing a multidisciplinary pain management programme (SA-MPMP), conventional patient-oriented multidisciplinary pain management programme (P-MPMP) and standard medical care (SMC). Thirty-six chronic low back pain (CLBP) patients and their spouses were randomly assigned to one of the three conditions. The SA-MPMP condition consisted of seven, weekly, 2-h, group sessions of training in dyadic pain coping and couple skills, delivered by a clinical psychologist with support of a multidisciplinary team of specialists, to patients together with their spouses. P-MPMP consisted of the SA-MPMP training delivered to the patient only (i.e., no spouse participation and assistance). The SMC condition entailed continuation of routine treatment, entailing medical care only. Data analysis revealed that, at the 12-month follow-up time point, patients receiving SA-MPMP had significant improvements in kinesiophobia and rumination about pain compared to those receiving P-MPMP and SMC. In patients suffering from CLBP, an intervention that combines spouse-assisted coping skills training with a multidisciplinary pain management programme can improve fear of movement and rumination about low back pain.

  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. Comparison between type-2 and type-1 myocardial infarction: clinical features, treatment strategies and outcomes

    PubMed Central

    López-Cuenca, Angel; Gómez-Molina, Miriam; Flores-Blanco, Pedro J; Sánchez-Martínez, Marianela; García-Narbon, Andrea; De Las Heras-Gómez, Ignacio; Sánchez-Galian, María J; Guerrero-Pérez, Esther; Valdés, Mariano; Manzano-Fernández, Sergio

    2016-01-01

    Objective To assess the differences in incidence, clinical features, current treatment strategies and outcome in patients with type-2 vs. type-1 acute myocardial infarction (AMI). Methods We included 824 consecutive patients with a diagnosis of type-1 or type-2 AMI. During index hospitalization, clinical features and treatment strategies were collected in detail. At 1-year follow-up, mortality, stroke, non-fatal myocardial infarction and major bleeding were recorded. Results Type-1 AMI was present in 707 (86%) of the cases while 117 (14%) were classified as type-2. Patients with type-2 AMI were more frequently female and had higher co-morbidities such as diabetes, previous non-ST segment elevation acute coronary syndromes, impaired renal function, anaemia, atrial fibrillation and malignancy. However, preserved left ventricular ejection fraction and normal coronary arteries were more frequently seen, an invasive treatment was less common, and anti-platelet medications, statins and beta-blockers were less prescribed in patients with type-2 AMI. At 1-year follow-up, type-2 AMI was associated with a higher crude mortality risk (HR: 1.75, 95% CI: 1.14–2.68; P = 0.001), but this association did not remain significant after multivariable adjustment (P = 0.785). Furthermore, we did not find type-2 AMI to be associated with other clinical outcomes. Conclusions In this real-life population, compared with type-1, type-2 AMI were predominantly women and had more co-morbidities. Invasive treatment strategies and cardioprotective medications were less used in type-2, while the 1-year clinical outcomes were similar. PMID:26918008

  8. 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"…

  9. Outpatient clinic referrals and their outcome.

    PubMed

    Sullivan, F M; Hoare, T; Gilmour, H

    1992-03-01

    A cohort of 392 patients referred to six outpatient clinics by general practitioners during 1987 with diagnoses of rheumatoid arthritis, osteoarthritis, peripheral vascular disease, psoriasis or eczema, were studied from the time of their first attendance until up to two years later. Six consultant clinics were studied in the three specialties: rheumatology, vascular surgery and dermatology. For each specialty a clinic in both a teaching hospital and a district general hospital were included. The cohort members were predominantly middle-aged or elderly people, with a greater proportion of women, except at the vascular surgery clinic where 65% of patients were men. The 392 patients made a total of 936 visits (median two, range one-eight) during the study period; 91 patients were still attending up to two years after the first visit. Patients referred by their general practitioner for therapy were less likely to be discharged than those referred for other reasons. The principal reason for continuing attendance as perceived by patients, general practitioners and hospital doctors was the necessity for consultant supervision, although agreement was far from complete in individual cases. Junior staff tended to see a higher proportion of patients at follow-up visits than did consultants, and were found to have lower discharge rates than consultants. Analyses of data showed that at the first visit, diagnosis, disease severity and the grade of doctor seeing the patient in the clinic was significantly associated with patient discharge at the P < 0.05 level of significance. Patients considered that their visits had produced improvement in their condition in 38% of cases.(ABSTRACT TRUNCATED AT 250 WORDS)

  10. Air Embolism: Diagnosis, Clinical Management and Outcomes

    PubMed Central

    McCarthy, Colin J.; Behravesh, Sasan; Naidu, Sailendra G.; Oklu, Rahmi

    2017-01-01

    Air embolism is a rare but potentially fatal complication of surgical procedures. Rapid recognition and intervention is critical for reducing morbidity and mortality. We retrospectively characterized our experience with air embolism during medical procedures at a tertiary medical center. Electronic medical records were searched for all cases of air embolism over a 25-year period; relevant medical and imaging records were reviewed. Sixty-seven air embolism cases were identified; the mean age was 59 years (range, 3–89 years). Ninety-four percent occurred in-hospital, of which 77.8% were during an operation/invasive procedure. Vascular access-related procedures (33%) were the most commonly associated with air embolism. Clinical signs and symptoms were related to the location the air embolus; 36 cases to the right heart/pulmonary artery, 21 to the cerebrum, and 10 were attributed to patent foramen ovale (PFO). Twenty-one percent of patients underwent hyperbaric oxygen therapy (HBOT), 7.5% aspiration of the air, and 63% had no sequelae. Mortality rate was 21%; 69% died within 48 hours. Thirteen patients had immediate cardiac arrest where mortality rate was 53.8%, compared to 13.5% (p = 0.0035) in those without. Air emboli were mainly iatrogenic, primarily associated with endovascular procedures. High clinical suspicion and early treatment are critical for survival. PMID:28106717

  11. Use of a Collagen Matrix as a Substitute for Free Mucosal Grafts in Pre-Prosthetic Surgery: 1 Year Results From a Clinical Prospective Study on 15 Patients

    PubMed Central

    Maiorana, Carlo; Beretta, Mario; Pivetti, Luca; Stoffella, Enrico; Grossi, Giovanni B.; Herford, Alan S.

    2016-01-01

    Background: The presence of keratinized tissue around dental implants is more than desirable either from a functional and aesthetic point of view, making soft tissue grafting a common practice in implant rehabilitation. Autogenous soft tissue grafting procedures are usually associated with high morbidity. Aim of this study was to assess the efficacy of a xenogeneic collagen matrix as a substitute for soft tissue grafting around dental implants. Methods: 15 consecutive patients underwent a vestibuloplasty and grafting, both in the mandible and the maxilla, with a collagen matrix. Results: The primary endpoint was to evaluate the resorption of the graft along with the re-epithelization grafted area. The percentage of the resorption was 44,4%, with a mean gain in vestibular height of 3 mm. Secondary endpoints evaluated the clinical appearance, the hemostatic effect and the post-operative pain. All subjects referred minimal pain with no bleeding. No adverse reaction nor infection were noted. Conclusion: This study showed that the used collagen matrix can find major interest in those patients who need a greater aesthetic outcome as the matrix has a perfect integration with the surrounding tissues. Furthermore it is strongly recommended for those patients who can bear little pain. Clinical Significance: Post-operative morbidity of autologous grafts is the biggest concern of this type of surgery. The possibility to use a soft tissue substitute is a great achievement as morbidity decreases and bigger areas can be treated in a single surgery. The present study showed the efficacy of a collagen matrix as this kind of substitute. PMID:27583050

  12. Outcomes assessment of clinical information system implementation: a practical guide.

    PubMed

    Nahm, Eun-Shim; Vaydia, Vinay; Ho, Danny; Scharf, Barbara; Seagull, Jake

    2007-01-01

    Healthcare information systems (HIS) play a vital role in quality of care and the organization's daily operations. Consequently, increasing numbers of clinicians have been involved in HIS implementation, particularly for clinical information systems (CIS). Implementation of these systems is a major organizational investment, and its outcomes must be assessed. The purpose of this article is to provide clinicians and frontline informaticians with a practical guide to assess these outcomes, focusing on outcome variables, assessment methods, and timing of assessment. Based on in-depth literature reviews and their empirical experiences, the authors identified 3 frequently used outcomes: user satisfaction, clinical outcomes, and financial impact. These outcomes have been assessed employing various methods, including randomized controlled trials, pre- and post-test studies, time and motion studies, surveys, and user testing. The timing for outcomes assessments varied depending on several factors, such as learning curves or patients conditions. In conclusion, outcomes assessment is essential for the success of healthcare information technology, and the CIS implementation team members must be prepared to conduct and/or facilitate these studies.

  13. Levothyroxine Poisoning - Symptoms and Clinical Outcome.

    PubMed

    Nygaard, Birgitte; Saedder, Eva A; Dalhoff, Kim; Wikkelsoe, Mette; Jürgens, Gesche

    2015-10-01

    Levothyroxine (LT), T4, poisoning is rarely associated with a severe outcome. However, cases with significant complications have been reported. The aim of this study was to identify factors associated with symptoms of poisoning including late-onset symptoms. All enquiries to the Danish Poison Information Centre (DPIC) concerning LT poisoning between March 2007 and September 2012 were reviewed and the following parameters were recorded: age, dose, time from ingestion, multiple drug intake and symptoms. To evaluate the frequency of late-onset symptoms, a subgroup of patients without initial symptoms were contacted. A total of 181 patients were registered (112 children). Ingested LT dose ranged from 10 to 9000 mcg (median 275 mcg). A total of 29 of 181 (16%) patients were symptomatic at the time of enquiry, and there was no difference in ingested LT dose between asymptomatic and symptomatic patients, neither in children nor in adults (age 16-92 years) (p < 0.68 and p < 0.47, respectively). In total, 153 of 181 (85%) patients did not have symptoms of poisoning at the time of enquiry; however, in 9 of 21 (43%) patients, we were able to contact, late-onset symptoms existed. In none of the cases, hospital contact was needed and there were no reports of long-term sequelae. Acute LT poisoning often follows a benign course. The occurrence of symptoms appears not to be dose dependent. Late-onset symptoms seem to be common. However, all symptoms resolved spontaneously without need of medical care.

  14. Identification and Use of Frailty Indicators from Text to Examine Associations with Clinical Outcomes Among Patients with Heart Failure.

    PubMed

    Shao, Yijun; Mohanty, April F; Ahmed, Ali; Weir, Charlene R; Bray, Bruce E; Shah, Rashmee U; Redd, Douglas; Zeng-Treitler, Qing

    2016-01-01

    Frailty is an important health outcomes indicator and valuable for guiding healthcare decisions in older adults, but is rarely collected in a quantitative, systematic fashion in routine healthcare. Using a cohort of 12,000 Veterans with heart failure, we investigated the feasibility of topic modeling to identify frailty topics in clinical notes. Topics were generated through unsupervised learning and then manually reviewed by an expert. A total of 53 frailty topics were identified from 100,000 notes. We further examined associations of frailty with age-, sex-, and Charlson Comorbidity Index-adjusted 1-year hospitalizations and mortality (composite outcome) using logistic regression. Frailty (≤ 4 topics versus <4) was associated with twice the risk of the composite outcome, Odds Ratio: 2.2, 95% Confidence Interval: (2.0-2.4). This study demonstrates the feasibility of identifying frailty indicators from clinical notes and linking these to clinically relevant outcomes. Future work includes integrating frailty indicators into validated predictive tools.

  15. Addressing missing participant outcome data in dental clinical trials.

    PubMed

    Spineli, Loukia M; Fleming, Padhraig S; Pandis, Nikolaos

    2015-06-01

    Missing outcome data are common in clinical trials and despite a well-designed study protocol, some of the randomized participants may leave the trial early without providing any or all of the data, or may be excluded after randomization. Premature discontinuation causes loss of information, potentially resulting in attrition bias leading to problems during interpretation of trial findings. The causes of information loss in a trial, known as mechanisms of missingness, may influence the credibility of the trial results. Analysis of trials with missing outcome data should ideally be handled with intention to treat (ITT) rather than per protocol (PP) analysis. However, true ITT analysis requires appropriate assumptions and imputation of missing data. Using a worked example from a published dental study, we highlight the key issues associated with missing outcome data in clinical trials, describe the most recognized approaches to handling missing outcome data, and explain the principles of ITT and PP analysis.

  16. Heparin monitoring: clinical outcome and practical approach.

    PubMed

    Despas, Noémie; Larock, Anne-Sophie; Jacqmin, Hugues; Douxfils, Jonathan; Chatelain, Bernard; Chatelain, Marc; Mullier, François

    2016-12-01

    Traditional anticoagulant agents such as unfractionated heparin (UFH), low molecular weight heparins (LMWHs), fondaparinux, danaparoid and bivalirudine are used in the prevention and treatment of thromboembolic diseases. However, these agents have limitations: their constraining parenteral route of administration and the need for regular coagulation monitoring for HNF. The LMWHs, with their more predictable anticoagulant response, don't require a systematic monitoring. The usefulness of LMWHs monitoring in several clinical situations such as pregnancy, obesity and renal insufficiency is a matter of debate. Indeed, there is no agreement between French and American recommendations on this question. Others aspects are also controversial: the measure of trough anti-Xa activity during pregnancy and the optimal monitoring of LMWHs for patients with antithrombin deficiency (hepatic disease, new-borns). Different tests are available to ensure the monitoring of these drugs, we will see in this review their principle, their advantages and inconvenients. The management of heparin induced thrombocytopenia also needs parenteral anticoagulants: danaparoïd, bivalirudine or argatroban. The modalities of their monitoring are relatively unknown and are presented. Furthermore, platelet monitoring is capital. This article aims to provide guidance about laboratory testing of classic parenteral anticoagulants.

  17. 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

  18. Aggressive Chordomas: Clinical Outcome of 13 Patients.

    PubMed

    Mavrogenis, Andreas F; Angelini, Andrea; Panagopoulos, Georgios N; Pala, Elisa; Calabrò, Teresa; Igoumenou, Vasilios G; Katzouraki, Galatia; Megaloikonomos, Panayiotis D; Pneumaticos, Spyros G; Papagelopoulos, Panayiotis J; Ruggieri, Pietro

    2017-03-01

    The authors reviewed the files of all patients with chordomas who were admitted and treated at their institutions from 1975 to 2012. Patients were categorized by early local recurrence and metastasis. Aggressive clinical behavior was defined as local recurrence and metastasis within 24 months of diagnosis and adequate treatment (wide en bloc resection with microscopically negative tumor margins). According to these criteria, 13 patients (14.3%) had aggressive chordomas, including 7 men and 6 women, with mean age of 54 years (range, 37-65 years) at diagnosis and treatment. All patients had preoperative tumor biopsy, followed by resection with partial (7 patients) or total sacrectomy (6 patients). In all cases, biopsy and histologic analysis of resected tumor specimens showed conventional chordomas. Resection margins were wide (grossly negative) in 6 patients and wide contaminated in 7 patients. Mean maximum tumor diameter was 11.8 cm (range, 5-21 cm). Mean follow-up was 43 months (range, 8-131 months). Rates of local recurrence, metastasis, and death were evaluated. At the last follow-up, all patients had local recurrence at a mean of 13 months (range, 5-22 months). Histologic examination of recurrent tumors showed a dedifferentiated chordoma with a fibrosarcoma component in 2 patients and no histologic change in the remaining patients. In addition, 8 patients had metastases at a mean of 13 months (range, 4-24 months) and died of their disease. All histologic findings of metastatic lesions were similar to those of primary tumors. Early diagnosis of aggressive tumors requires close follow-up of patients with chordomas. Metastasis is common, with resultant poor survival. [Orthopedics. 2017; 40(2):e248-e254.].

  19. Meta-analysis of long-term clinical outcomes of everolimus-eluting stents.

    PubMed

    Toyota, Toshiaki; Shiomi, Hiroki; Morimoto, Takeshi; Kimura, Takeshi

    2015-07-15

    The superiority of everolimus-eluting stents (EES) over sirolimus-eluting stents (SES) for long-term clinical outcomes has not been yet firmly established. We conducted a systematic review and a meta-analysis of randomized controlled trials (RCTs) comparing EES directly with SES using the longest available follow-up data. We searched PubMed, the Cochrane database, and ClinicalTrials.gov for RCTs comparing outcomes between EES and SES and identified 13,434 randomly assigned patients from 14 RCTs. EES was associated with significantly lower risks than SES for definite stent thrombosis (ST), definite/probable ST, target-lesion revascularization (TLR), and major adverse cardiac events (MACE). The risks for all-cause death and myocardial infarction were similar between EES and SES. By the stratified analysis according to the timing after stent implantation, the favorable trend of EES relative to SES for ST, TLR, and MACE was consistently observed both within and beyond 1 year. The lower risk of EES relative to SES for MACE beyond 1 year was statistically significant (pooled odds ratio 0.77, 95% confidence interval 0.61 to 0.96, p = 0.02). In conclusion, the current meta-analysis of 14 RCTs directly comparing EES with SES suggested that EES provided improvement in both safety and efficacy; EES compared with SES was associated with significantly lower risk for definite ST, definite/probable ST, TLR, and MACE. The direction and magnitude of the effect beyond 1 year were comparable with those observed within 1 year.

  20. 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.

  1. Outcome Measures in Clinical Trials for Multiple Sclerosis.

    PubMed

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

    2017-02-09

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

  2. Germline determinants of clinical outcome of cutaneous melanoma.

    PubMed

    Vogelsang, Matjaz; Wilson, Melissa; Kirchhoff, Tomas

    2016-01-01

    Cutaneous melanoma (CM) is the most lethal form of skin cancer. Despite the constant increase in melanoma incidence, which is in part due to incremental advances in early diagnostic modalities, mortality rates have not improved over the last decade and for advanced stages remain steadily high. While conventional prognostic biomarkers currently in use find significant utility for predicting overall general survival probabilities, they are not sensitive enough for a more personalized clinical assessment on an individual level. In recent years, the advent of genomic technologies has brought the promise of identification of germline DNA alterations that may associate with CM outcomes and hence represent novel biomarkers for clinical utilization. This review attempts to summarize the current state of knowledge of germline genetic factors studied for their impact on melanoma clinical outcomes. We also discuss ongoing problems and hurdles in validating such surrogates, and we also project future directions in discovery of more powerful germline genetic factors with clinical utility in melanoma prognostication.

  3. Outcomes of a Nurse-Managed Diabetes Foot Clinic

    DTIC Science & Technology

    2016-06-07

    Managed Diabetes Foot Clinic 5b. GRANT NUMBER HU0001-04-1-TS10 5c. PROGRAM ELEMENT NUMBER N/A 6. AUTHOR(S) 5d. PROJECT NUMBER N04-017...measured outcomes of a nurse-managed diabetes foot clinic on foot wound rates, health care costs, and changes in health status in adults with... diabetes . Design: This study reflects results of a two-group randomized, controlled trial. Sample: Participants were 126 adults with diabetes for more

  4. 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

  5. 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.

  6. Clinical trials in systemic sclerosis: lessons learned and outcomes

    PubMed Central

    Matucci-Cerinic, Marco; Steen, Virginia D; Furst, Daniel E; Seibold, James R

    2007-01-01

    The pathogenesis of systemic sclerosis (SSc) is complex and largely unclear. The clinical heterogeneity of the disease and its progression over a number of years makes the choice of endpoints in the design of clinical trials difficult. The overwhelming need in this disease is to diagnose it early and identify those patients who will benefit most from early, aggressive treatment that potentially can alter the clinical disease course. To achieve this, innumerable challenges must be overcome. This article reviews data from recent clinical trials and the lessons derived from retrospective observational studies, databases, and patient registries. Taken together, these observations will help to improve our understanding of the diverse clinical course of SSc and permit refinement of existing outcome measures for the design of future clinical trials, in which the likelihood of observing a positive treatment effect with the drugs at our disposal will be maximized. PMID:17767745

  7. [Computer-assisted cardiovascular disease management: better implementation of care but no improvement in clinical outcomes].

    PubMed

    de Wit, Niek J

    2012-01-01

    Computer support is considered by many to be a promising strategy for improving healthcare interventions, especially in the management of chronic diseases. So far, however, evidence of the effectiveness of ICT support in healthcare is limited. Recently, computer-supported cardiovascular disease management was compared with usual care during an RCT comprised of 1100 primary care patients. This trial demonstrated that neither the clinical outcome nor the cardiovascular morbidity rate improved, even though management of the risk factors improved over 1 year of follow-up. The pragmatic design of the RCT in daily general practice may have restricted implementing the computer support, and may also have hampered the evaluation of the cardiovascular effects. The results demonstrate that although computer support may help improve the performance of disease management, its impact on disease outcomes is questionable. ICT innovations in healthcare require rigorous investigative evaluation before their implementation in daily practice can be justified.

  8. 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

  9. 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…

  10. Lipidomic analysis enables prediction of clinical outcomes in burn patients

    PubMed Central

    Qi, Peter; Abdullahi, Abdikarim; Stanojcic, Mile; Patsouris, David; Jeschke, Marc G.

    2016-01-01

    Recent discoveries have highlighted the novel metabolic functions of adipose tissue in enhancing hypermetabolism after trauma. As the exact function and expression profiles of serum lipids and free fatty acids (FFA) are essentially unknown, we determined the lipidomic expression profile after burn in correlation to clinical outcomes to identify important lipid mediators affecting post-burn outcomes. We conducted a prospective cohort study with 46 adult burn patients and 5 healthy controls at the Ross Tilley Burn Center in Toronto, Canada. Patients were stratified based on major demographic and clinical variables, including age, burn severity, mortality, and sepsis. Serum FFAs and inflammatory markers were measured during acute hospital stay. We found that FFAs were acutely elevated post-burn and returned to baseline over time. Greater burn severity and age were associated with an impaired acute response in unsaturated FFAs and pro-inflammatory cytokines. Elevations in saturated and mono-unsaturated FFAs correlated significantly to increased mortality. In summary, persistent elevation of unsaturated lipids was associated with a functionally altered inflammatory-immunological milieu and worse clinical outcomes. The present lipidomic analysis indicates profound alterations in the lipid profile after burn by characterizing key lipids as potential diagnostic and outcome indicators in critically injured patients. PMID:27982130

  11. 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

  12. 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.

  13. Pretreatment clinical and psychosocial predictors of remission from depression after short-term psychodynamic psychotherapy and solution-focused therapy: a 1-year follow-up study.

    PubMed

    Marttunen, Mauri; Valikoski, Maarit; Lindfors, Olavi; Laaksonen, Maarit A; Knekt, Paul

    2008-03-01

    The mutual importance of different predictors of remission was studied in 163 outpatients with depression receiving either short-term psychodynamic psychotherapy or solution-focused therapy. After a 1-year follow-up, the percentage of remission significantly varied between sociodemographic subgroups and was dependent on severity of symptoms, personality disorder, and psychosocial factors but not on psychiatric history, previous psychiatric treatment, or type of therapy received. Simultaneous study showed that the most significant predictors were sense of coherence (based on Sense of Coherence Scale [SOCS]), symptom severity (based on Symptom Checklist-90 [SCL-90] Global Severity Index [GSI]), and education. The relative risks of remission between the lowest and highest quartiles of SOCS and SCL-90 GSI were 0.06 and 0.22 (95% confidence intervals = 0.01-0.35 and 0.05-0.97), respectively. In conclusion, several background factors, especially sense of coherence, predict remission.

  14. 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

  15. Severe Acute Respiratory Syndrome: Clinical Outcome and Prognostic Correlates1

    PubMed Central

    Kwok, Man Leung; Yuen, Hon; Lai, Sik To

    2003-01-01

    Severe acute respiratory syndrome (SARS) poses a major threat to the health of people worldwide. We performed a retrospective case series analysis to assess clinical outcome and identify pretreatment prognostic correlates of SARS, managed under a standardized treatment protocol. We studied 127 male and 196 female patients with a mean age of 41±14 (range 18–83). All patients, except two, received ribavirin and steroid combination therapy. In 115 (36%) patients, the course of disease was limited. Pneumonitis progressed rapidly in the remaining patients. Sixty-seven (21%) patients required intensive care, and 42 (13%) required ventilator support. Advanced age, high admission neutrophil count, and high initial lactate dehydrogenase level were independent correlates of an adverse clinical outcome. SARS-associated coronavirus caused severe illnesses in most patients, despite early treatment with ribavirin and steroid. This study has identified three independent pretreatment prognostic correlates. PMID:14519241

  16. 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

  17. 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.

  18. Clinical Features and Treatment Outcomes of Childhood Autoimmune Hemolytic Anemia: A Retrospective Analysis of 68 Cases.

    PubMed

    Fan, Junjie; He, Hailong; Zhao, Wenli; Wang, Yi; Lu, Jun; Li, Jie; Li, Jianqin; Xiao, Peifang; Lu, Ye; Chai, Yihuan; Hu, Shaoyan

    2016-03-01

    Autoimmune hemolytic anemia (AIHA) is a rare disease in children, and its clinical severity varies. To better understand disease manifestation and treatment outcome, we analyzed 68 children diagnosed as AIHA for clinical characteristics, laboratory findings, and treatment outcomes. Data show that primary AIHA accounted for 39.7% of all patients, whereas secondary AIHA accounted for 60.3%. Among them, Evans syndrome (ES) accounted for 20 cases (29.4%). Average hemoglobin was lower in the 1-year or below age group than in the above 1-year age group, combined-antibody group than single-antibody group, and IgM-contained group than non-IgM-contained group (P<0.05 for all). The duration of therapy in the ES group was longer than that in the AIHA-only group (P<0.05). During the follow-up period, 29 cases (29/45, 64.4%) remained in continuous remission. In total, 35.6% of patients relapsed after first complete remission and 56.3% of them still showed good response to glucocorticoid after relapse. There was no difference in the duration of therapy or relapse rate between the intravenous immunoglobulin (IVIG)-treatment group and the non-IVIG-treatment group. In conclusion, the severity of anemia correlates with age and serologic types of direct antiglobulin test. Glucocorticoid is efficacious for AIHA regardless of whether it is a first attack or relapse in this cohort of young patients. ES needs longer treatment duration. IVIG does not improve the outcome of AIHA.

  19. 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

  20. Trauma experience among homeless female veterans: correlates and impact on housing, clinical, and psychosocial outcomes.

    PubMed

    Tsai, Jack; Rosenheck, Robert A; Decker, Suzanne E; Desai, Rani A; Harpaz-Rotem, Ilan

    2012-12-01

    This study examined lifetime exposure to traumatic events as reported by 581 homeless female veterans enrolled in a Homeless Women Veterans Program across 11 sites to characterize the types of trauma they experienced; their correlation with baseline characteristics; and their association with housing, clinical outcomes, and psychosocial functioning over a 1-year treatment period. Almost all participants endorsed multiple types and episodes of traumatic events. Among the most common were having someone close experience a serious or life-threatening illness (82%) and rape (67%). Exploratory factor analysis revealed 6 potential trauma categories: being robbed, experiencing accident or disasters, illness or death of others, combat, sexual assault, and physical assault. At baseline, trauma from sexual assault was associated with more days homeless (β = .18, p < .001), trauma from accidents or disasters was associated with poorer physical health (β = -.23, p < .001), and trauma from being robbed was related to greater use of drugs (β = .22, p < .001). Trauma reported at baseline, however, was not predictive of 1-year outcomes, suggesting type and frequency of trauma does not negatively affect the housing gains homeless women veterans can achieve through homeless services.

  1. Liver transplantation for progressive familial intrahepatic cholestasis: clinical and histopathological findings, outcome and impact on growth.

    PubMed

    Aydogdu, Sema; Cakir, Murat; Arikan, C; Tumgor, Gokhan; Yuksekkaya, Hasan Ali; Yilmaz, Funda; Kilic, Murat

    2007-09-01

    In this study, we analyze the demographic features, clinical and histopathological findings in patients who underwent liver transplantation for progressive familial intrahepatic cholestasis. We also analyze outcome and impact of liver transplantation on growth and bone mineral content. Most of the patients were presented with jaundice mainly beginning within the first six months. At the time of initial admission; eight patients had short stature (height SD score<2), and four patients had weight SD score<2. Liver transplantation were performed at the age of 43.2+/-27 months (range 9 to 96 months), 6.5+/-3.5 months later after the first admission. Infection, surgical complications and osmotic diarrhea associated with severe metabolic acidosis were noted in 41.4%, 16.6% and 33.3%, respectively. One patient developed posttransplant lymphoproliferative disorder. Overall; 1 year graft and patient survival was 69.2% and 75%, respectively. At the end of the 1st year only 2 patients had height SD score<2. Linear regression of height gain against increase in total body BMD measured at the time of transplantation and 1 year after liver transplantation gave a coefficient r=0.588 (p=0.074). No correlation was found between the height gain and age and PELD score at time of transplantation, and no difference was noted between the sexes and donor type. Liver transplantation is effective treatment modality with good outcome and little morbidity, and increases the growth acceleration in patients with PFIC associated with cirrhosis.

  2. Clinical features and surgical outcomes of primary canaliculitis with concretions

    PubMed Central

    Xiang, Shengjin; Lin, Bin; Pan, Qintuo; Zheng, Meiqin; Qin, Xiaoyi; Wang, Youpei; Zhang, Zongduan

    2017-01-01

    Abstract The purpose of our study is to analyze the clinical, ultrasonic, microbiologic, and histopathologic characteristics, management, and outcomes in a series of primary canaliculitis with concretions patients who underwent canaliculotomy with curettage. Thirty-six patients were reviewed for age, sex, location and laterality, duration of symptoms, clinical symptoms, ultrasonic signs, result of microbiologic culture and histopathologic examination, treatment, and outcomes. Main outcomes were the clinical, ultrasonic, and microbiological characteristics of the canalicular concretions; the histopathologic profiles; and the treatment effect. Thirty-six patients were identified with concretions in all 37 cases of the patients with canaliculitis. There were 30 (83.3%) female patients with a mean age of 54.2 years. Twenty-eight (77.8%) patients were misdiagnosed or delayed diagnosed, and the mean duration was 17.1 months. The common most clinical presentations were discharge (100%), epiphora (66.7%), erythema (52.8%), and swelling (47.2%), and concretions were found in 31 of 37 patients by typical clinical manifestations and in 5 of 6 patients by ultrasonic. Actinomyces was found in 8 of 13 histopathologic specimens, and microbiological cultures were positive in 13 of 24 patients. All patients underwent canaliculotomy with curettage to completely remove all concretions and contents; 35 of 36 patients’ symptoms improved and 1 recurred after treatment at a median of 21.7 months follow-up according to the telephonic questionnaires. Canalicular concretions play an important role in primary canaliculitis. Canaliculotomy with curettage is a standard therapy with canalicular concretions, and the surgical removal of all possible concretions is essential for cure. PMID:28248874

  3. Clinical manifestations and outcomes of pulmonary aspergillosis: experience from Pakistan

    PubMed Central

    Iqbal, Nousheen; Irfan, Muhammad; Zubairi, Ali Bin Sarwar; Jabeen, Kauser; Awan, Safia; Khan, Javaid A

    2016-01-01

    Introduction Pulmonary aspergillosis has variable course of illness, severity and outcomes depending on underlying conditions. There is limited data available on the clinical manifestations and outcome of pulmonary aspergillosis from Pakistan. Methods To determine the clinical manifestations and outcome of pulmonary aspergillosis in a tertiary care hospital a retrospective study was conducted from 2004 to 2014 in patients admitted with pulmonary aspergillosis at the Aga Khan University Hospital Karachi, Pakistan. Results Of the 280 cases with provisional diagnosis of aspergillosis 69 met the inclusion criteria. The mean age was 45±15.7 years, 48 (69.6%) were men and 21 (30.4%) had diabetes mellitus (DM). The average length of hospital stay (LOS) was 10.61±9.08 days. Aspergillus fumigatus was the most common (42.0%), followed by Aspergillus flavus (28.9%). More than one-third of patients previously had tuberculosis (TB) (39.13%). The commonest pulmonary manifestation was chronic pulmonary aspergillosis (CPA) 47 (68.1%) followed by invasive pulmonary aspergillosis (IPA) 12 (17.4%) and subacute invasive aspergillosis (SAIA) 8 (11.6%). Surgical excision was performed in 28 patients (40.57%). Intensive care unit admission was required for 18 patients (26.08%). Case fatality rate was 14/69 (20.3%). DM, mean LOS and hypoxic respiratory failure were identified as independent risk factors of mortality on multivariate analysis. Conclusion A. fumigatus was the most frequent species found especially in patients with prior TB. CPA was the commonest pulmonary manifestation seen as post TB sequel. Diabetes, hypoxic respiratory failure and increased LOS were independent predictors of poor outcomes. Overall patients had good outcome with CPA compared with SAIA and IPA. PMID:28074136

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

    PubMed

    Rosenstein, Alan H; O'Daniel, Michelle

    2005-01-01

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

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

    PubMed Central

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

    2014-01-01

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

  6. Clinical Outcomes according to the Achievement of Target Low Density Lipoprotein-Cholesterol in Patients with Acute Myocardial Infarction

    PubMed Central

    Ahn, Taehoon; Lee, Kyounghoon; Kang, Woong Chol; Han, Seung Hwan; Ahn, Youngkeun; Jeong, Myung Ho

    2017-01-01

    Background and Objectives The clinical outcome of patient with an acute myocardial infarction (AMI) undergoing percutaneous coronary intervention (PCI), with or without achievement of target low density lipoprotein-cholesterol (LDL-C), has little known information. This study investigated if target LDL-C level (below 70 mg/dL) achievements in patients with AMI showed better clinical outcomes or not. Subjects and Methods Between May 2008 and September 2012, this study enrolled 13473 AMI patients in a large-scale, prospective, multicenter Korean Myocardial Infarction (KorMI) registry. 12720 patients survived and 6746 patients completed a 1-year clinical follow up. Among them 3315 patients received serial lipid profile follow-ups. Propensity score matching was applied to adjust for differences in clinical baseline and angiographic characteristics, producing a total of 1292 patients (646 target LDL-C achievers vs. 646 non-achievers). The primary end point was the composite of a 1-year major adverse cardiac event (MACE) including cardiac death, recurrent myocardial infarction (MI), target lesion revascularization (TLR) and coronary artery bypass grafting. Results After propensity score matching, baseline clinical and angiographic characteristics were similar between the two groups. Clinical outcomes of the propensity score matched patients who showed no significant differences in cardiac death (0.5% vs. 0.5%, p=1.000), recurrent MI (1.1% vs. 0.8%, p=0.562), TLR (5.0% vs. 4.5%, p=0.649), MACEs (6.5% vs. 5.9%, p=0.644) and stent thrombosis (2.5% vs. 1.9%, p=0.560). Conclusion In this propensity-matched comparison, AMI patients undergoing PCI with a target LDL-C (below 70 mg/dL) achievement did not show better clinical outcomes. PMID:28154588

  7. Looking beyond historical patient outcomes to improve clinical models.

    PubMed

    Chia, Chih-Chun; Rubinfeld, Ilan; Scirica, Benjamin M; McMillan, Sean; Gurm, Hitinder S; Syed, Zeeshan

    2012-04-25

    Conventional algorithms for modeling clinical events focus on characterizing the differences between patients with varying outcomes in historical data sets used for the model derivation. For many clinical conditions with low prevalence and where small data sets are available, this approach to developing models is challenging due to the limited number of positive (that is, event) examples available for model training. Here, we investigate how the approach of developing clinical models might be improved across three distinct patient populations (patients with acute coronary syndrome enrolled in the DISPERSE2-TIMI33 and MERLIN-TIMI36 trials, patients undergoing inpatient surgery in the National Surgical Quality Improvement Program registry, and patients undergoing percutaneous coronary intervention in the Blue Cross Blue Shield of Michigan Cardiovascular Consortium registry). For each of these cases, we supplement an incomplete characterization of patient outcomes in the derivation data set (uncensored view of the data) with an additional characterization of the extent to which patients differ from the statistical support of their clinical characteristics (censored view of the data). Our approach exploits the same training data within the derivation cohort in multiple ways to improve the accuracy of prediction. We position this approach within the context of traditional supervised (2-class) and unsupervised (1-class) learning methods and present a 1.5-class approach for clinical decision-making. We describe a 1.5-class support vector machine (SVM) classification algorithm that implements this approach, and report on its performance relative to logistic regression and 2-class SVM classification with cost-sensitive weighting and oversampling. The 1.5-class SVM algorithm improved prediction accuracy relative to other approaches and may have value in predicting clinical events both at the bedside and for risk-adjusted quality of care assessment.

  8. 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

  9. 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

  10. Spontaneous Primary Intraventricular Hemorrhage: Clinical Features and Early Outcome

    PubMed Central

    Arboix, Adrià; García-Eroles, Luis; Vicens, Adela; Oliveres, Montserrat; Massons, Joan

    2012-01-01

    Purpose. Primary hemorrhage in the ventricular system without a recognizable parenchymal component is very rare. This single-center retrospective study aimed to further characterize the clinical characteristics and early outcome of this stroke subtype. Methods. All patients with primary intraventricular hemorrhage included in a prospective hospital-based stroke registry over a 19-year period were assessed. A standardized protocol with 161 items, including demographics, risk factors, clinical data, neuroimaging findings, and outcome, was used for data collection. A comparison was made between the groups of primary intraventricular hemorrhage and subcortical intracerebral hemorrhage. Predictors of primary intraventricular hemorrhage were identified by logistic regression analysis. Results. There were 12 patients with primary intraventricular hemorrhage (0.31% of all cases of stroke included in the database) and 133 in the cohort of subcortical hemorrhage. Very old age (≥85 years) (odds ratio (OR) 9.89), atrial fibrillation (OR 8.92), headache (OR 6.89), and altered consciousness (OR 4.36) were independent predictors of intraventricular hemorrhage. The overall in-hospital mortality rate was 41.7% (5/12) but increased to 60% (3/5) in patients aged 85 years or older. Conclusion. Although primary intraventricular hemorrhage is uncommon, it is a severe clinical condition with a high early mortality. The prognosis is particularly poor in very old patients. PMID:22966468

  11. Clinical symptoms and microbiological outcomes in tuberculosis treatment trials.

    PubMed

    Bark, C M; Dietze, R; Okwera, A; Quelapio, M I; Thiel, B A; Johnson, J L

    2011-11-01

    During a recent Food and Drug Administration workshop on clinical trials to evaluate new TB drugs, questions were raised regarding the use of bacteriologic endpoints such as treatment failure and relapse as measures of improvement in health status and long term outcome after treatment. FDA scientists asked how patients' clinical signs and symptoms changed during therapy, noting that while such information is usually collected during clinical trials, it is not often reported. We analyzed data from an international phase 3 TB treatment trial that included systematic assessments of symptoms. The percentage of subjects with self-reported symptoms at baseline ranged from 30% for dyspnea to 81% for cough, with 51% reporting fever. During therapy, fever, sweats, and dyspnea decreased most rapidly, with near resolution by the end of therapy. Chest pain and cough resolved more slowly; 13% of subjects reported cough at six months. Symptom resolution during treatment did not differ between those who relapsed and those who did not. Among those with microbiological relapse, symptoms returned with significant increases in the proportion with fever, cough, and chest pain. At the time of relapse, cough was the most frequent symptom, occurring in 75% of subjects who relapsed but only 12% of those who did not. Our data support the continued use of bacteriologic endpoints based on sputum culture as surrogate measures of the relief of symptoms, improvement in health status and favorable long term treatment outcome in TB drug trials.

  12. Clinical and Environmental Surveillance for Vibrio cholerae in Resource Constrained Areas: Application during a 1-Year Surveillance in the Far North Region of Cameroon

    PubMed Central

    Debes, Amanda K.; Ateudjieu, Jerome; Guenou, Etienne; Ebile, Walter; Sonkoua, Isaac Tadzong; Njimbia, Anthony Chebe; Steinwald, Peter; Ram, Malathi; Sack, David A.

    2016-01-01

    Biological confirmation of the presence of Vibrio cholerae in clinical and environmental samples is often constrained due to resource- and labor-intensive gold standard methods. To develop low-cost, simple, and sustainable surveillance techniques, we modified previously published specimen sampling and culture techniques and applied the use of enriched dipstick testing in conjunction with the use of filter paper for DNA specimen preservation during clinical and environmental surveillance in the Far North of Cameroon from August 2013 to October 2014. The enriched dipstick methodology during routine use in a remote setting demonstrated a specificity of 99.8% compared with polymerase chain reaction (PCR). The novel application of filter paper as a preservation method for cholera DNA specimens reduced the need for cold chain storage and allowed for PCR characterization and confirmation of V. cholerae. The application of basic technologies such as the enriched dipstick, the use of simplified gauze filtration for environmental sample collection, and the use of filter paper for sample preservation enabled early case identification with reduced logistics and supply cost while reporting minimal false-positive results. Simplified laboratory and epidemiological methodologies can improve the feasibility of cholera surveillance in rural and resource-constrained areas, facilitating early case detection and rapid response implementation. PMID:26755564

  13. Clinical and Environmental Surveillance for Vibrio cholerae in Resource Constrained Areas: Application During a 1-Year Surveillance in the Far North Region of Cameroon.

    PubMed

    Debes, Amanda K; Ateudjieu, Jerome; Guenou, Etienne; Ebile, Walter; Sonkoua, Isaac Tadzong; Njimbia, Anthony Chebe; Steinwald, Peter; Ram, Malathi; Sack, David A

    2016-03-01

    Biological confirmation of the presence of Vibrio cholerae in clinical and environmental samples is often constrained due to resource- and labor-intensive gold standard methods. To develop low-cost, simple, and sustainable surveillance techniques, we modified previously published specimen sampling and culture techniques and applied the use of enriched dipstick testing in conjunction with the use of filter paper for DNA specimen preservation during clinical and environmental surveillance in the Far North of Cameroon from August 2013 to October 2014. The enriched dipstick methodology during routine use in a remote setting demonstrated a specificity of 99.8% compared with polymerase chain reaction (PCR). The novel application of filter paper as a preservation method for cholera DNA specimens reduced the need for cold chain storage and allowed for PCR characterization and confirmation of V. cholerae. The application of basic technologies such as the enriched dipstick, the use of simplified gauze filtration for environmental sample collection, and the use of filter paper for sample preservation enabled early case identification with reduced logistics and supply cost while reporting minimal false-positive results. Simplified laboratory and epidemiological methodologies can improve the feasibility of cholera surveillance in rural and resource-constrained areas, facilitating early case detection and rapid response implementation.

  14. 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

  15. Anesthesia clinical performance outcomes: does teaching method make a difference?

    PubMed

    McLain, Nina E; Biddle, Chuck; Cotter, J James

    2012-08-01

    The purpose of this study was to compare traditional methods of instruction to the use of audiovisual patient safety vignettes in terms of their impact on student registered nurse anesthetists' recall and subsequent clinical performance. These vignettes used simulated, crisis-oriented anesthetic events known to be associated with catastrophic patient outcomes. Using a randomized controlled crossover trial, 24 student registered nurse anesthetists encountered either a malfunctioning suction device vignette or a stuck expiratory unidirectional valve vignette. Recall and clinical performances were measured after exposure to a lecture and written case studies or to lecture and patient safety vignettes. Of the 24 students, 23 were able to recognize the malfunctioning components and take corrective action. In this research study, memory and clinical performance were significantly affected when the anesthesia provider incorporated the correct anesthesia apparatus checkout process and crisis management skills into practice. This research demonstrated that under the conditions of this study, teaching methods had an impact on some areas of clinical performance. In this study, crisis-oriented, anesthesia patient safety vignettes had the potential to affect recall and clinical performance in a simulated environment.

  16. Use of Percutaneous Aspiration Thrombectomy vs. Anticoagulation Therapy to Treat Acute Iliofemoral Venous Thrombosis: 1-year Follow-up Results of a Randomised, Clinical Trial

    SciTech Connect

    Cakir, Volkan; Gulcu, Aytac; Akay, Emrah; Capar, Ahmet E.; Gencpinar, Tugra; Kucuk, Banu; Karabay, Ozalp; Goktay, A. Yigit

    2014-08-15

    PurposeThe purpose of this study was to compare the efficacy of percutaneous aspiration thrombectomy (PAT) followed by standard anticoagulant therapy, with anticoagulation therapy alone, for the treatment of acute proximal lower extremity deep vein thrombosis.MethodsIn this randomised, prospective study, 42 patients with acute proximal iliofemoral deep vein thrombosis documented via Doppler ultrasound examination, were separated into an interventional treatment group (16 males, 5 females, average age 51 years) and a medical treatment group (13 males, 8 females, average age 59 years). In the interventional group, PAT with large-lumen 9-F diameter catheterisation was applied, after initiation of standard anticoagulant therapy. Balloon angioplasty (n 19) and stent implementation (n: 14) were used to treat patients with residual stenosis (>50 %) after PAT. Prophylactic IVC filters were placed in two patients. The thrombus clearance status of the venous system was evaluated by venography. In both the medical and interventional groups, venous patency rates and clinical symptom scores were evaluated at months 1, 3, and 12 after treatment.ResultsDeep venous systems became totally cleared of thrombi in 12 patients treated with PAT. The venous patency rates in month 12 were 57.1 and 4.76 % in the interventional and medical treatment groups, respectively. A statistically significant improvement was observed in clinical symptom scores of the interventional group (PAT) with or without stenting (4.23 ± 0.51 before treatment; 0.81 ± 0.92 at month 12) compared with the medical treatment group (4.00 ± 0.63 before treatment; 2.43 ± 0.67 at month 12). During follow-up, four patients in the medical treatment and one in the interventional group developed pulmonary embolisms.ConclusionsFor treatment of acute deep vein thrombosis, PAT with or without stenting is superior to anticoagulant therapy alone in terms of both ensuring venous patency and improving clinical

  17. Relationship Between Severity Classification of Acute Exacerbation of Chronic Obstructive Pulmonary Disease and Clinical Outcomes in Hospitalized Patients

    PubMed Central

    Sanjuán, Pilar; Huerta, Arturo; Nieto-Codesido, Irene; Ferreira-Gonzalez, Lucía; Sibila, Oriol; Restrepo, Marcos I

    2017-01-01

    Background Limited data are available regarding the impact of the potential validation of the Canadian Thoracic Society (CTS) guidelines recommendations in classifying patients with an acute exacerbation of chronic obstructive pulmonary disease (AECOPD) in simple and complex. The aim of the present study was to assess the CTS recommendations regarding risk stratification on clinical outcomes among patients hospitalized with an AECOPD. Methods We developed a retrospective cohort study of patients admitted to one tertiary hospital with a diagnosis of AECOPD. The main clinical outcome was the percentage of treatment failure. Secondary outcomes were 30-day, 90-day, and 1-year readmission and mortality rate, length of stay in hospital, intensive care unit (ICU) admission rate, time to readmission, and time to death. Multivariate analyses were performed using 1-year mortality rate as the dependent measures. Results One hundred forty-three patients composed the final study population, most of them (106 [74.1%)] classified as complex acute exacerbation (C-AE) of COPD. C-AE patients had similar rate of treatment failure compared with simple acute exacerbation (S-AE) of COPD (31.1% vs. 27%; p = 0.63). There were no differences regarding the length of stay in hospital, ICU admission rate, and 30-day, 90-day, and 1-year readmission rate. C-AE patients had faster declined measures on time to death (691.6 ± 430 days vs. 998.1 ± 355 days; p = 0.02). In the multivariate analysis, after adjusting for comorbidity, lung function and previous treatment, C-AE patients had a significant higher mortality at one year (Odds Ratio [OR] = 4.9 (Confidence Interval [CI] 95%: 1.16-21); p = 0.031). Conclusions In hospitalized patients with an AECOPD, CTS classification, according to the presence of risk factors, was not associated with worse short-term clinical outcomes although it is related with long-term mortality.  PMID:28265524

  18. Comparison of 1-Year Outcome in Patients With Severe Aorta Stenosis Treated Conservatively or by Aortic Valve Replacement or by Percutaneous Transcatheter Aortic Valve Implantation (Data from a Multicenter Spanish Registry).

    PubMed

    González-Saldivar, Hugo; Rodriguez-Pascual, Carlos; de la Morena, Gonzalo; Fernández-Golfín, Covadonga; Amorós, Carmen; Alonso, Mario Baquero; Dolz, Luis Martínez; Solé, Albert Ariza; Guzmán-Martínez, Gabriela; Gómez-Doblas, Juan José; Jiménez, Antonio Arribas; Fuentes, María Eugenia; Gay, Laura Galian; Ortiz, Martin Ruiz; Avanzas, Pablo; Abu-Assi, Emad; Ripoll-Vera, Tomás; Díaz-Castro, Oscar; Osinalde, Eduardo P; Martínez-Sellés, Manuel

    2016-07-15

    The factors that influence decision making in severe aortic stenosis (AS) are unknown. Our aim was to assess, in patients with severe AS, the determinants of management and prognosis in a multicenter registry that enrolled all consecutive adults with severe AS during a 1-month period. One-year follow-up was obtained in all patients and included vital status and aortic valve intervention (aortic valve replacement [AVR] and transcatheter aortic valve implantation [TAVI]). A total of 726 patients were included, mean age was 77.3 ± 10.6 years, and 377 were women (51.8%). The most common management was conservative therapy in 468 (64.5%) followed by AVR in 199 (27.4%) and TAVI in 59 (8.1%). The strongest association with aortic valve intervention was patient management in a tertiary hospital with cardiac surgery (odds ratio 2.7, 95% confidence interval 1.8 to 4.1, p <0.001). The 2 main reasons to choose conservative management were the absence of significant symptoms (136% to 29.1%) and the presence of co-morbidity (128% to 27.4%). During 1-year follow-up, 132 patients died (18.2%). The main causes of death were heart failure (60% to 45.5%) and noncardiac diseases (46% to 34.9%). One-year survival for patients treated conservatively, with TAVI, and with AVR was 76.3%, 94.9%, and 92.5%, respectively, p <0.001. One-year survival of patients treated conservatively in the absence of significant symptoms was 97.1%. In conclusion, most patients with severe AS are treated conservatively. The outcome in asymptomatic patients managed conservatively was acceptable. Management in tertiary hospitals is associated with valve intervention. One-year survival was similar with both interventional strategies.

  19. Early Choline Levels From 3-Tesla MR Spectroscopy After Exclusive Radiation Therapy in Patients With Clinically Localized Prostate Cancer are Predictive of Plasmatic Levels of PSA at 1 Year

    SciTech Connect

    Crehange, Gilles; Maingon, Philippe; Gauthier, Melanie; Parfait, Sebastien; Cochet, Alexandre; Mirjolet, Celine; Bonnetain, Franck; Cormier, Luc; Brunotte, Francois; Walker, Paul

    2011-11-15

    Purpose: To investigate the time course response of prostate metabolism to irradiation using magnetic resonance spectroscopy (MRS) at 3-month intervals and its impact on biochemical control. Methods and Materials: Between January 2008 and April 2010, 24 patients with localized prostate cancer were prospectively enrolled in the Evaluation of the Response to Irradiation with MR Spectroscopy (ERIS) trial. All the patients had been treated with intensity-modulated radiation therapy with or without long-term adjuvant hormonal therapy (LTHT) and underwent 3-T MRS and prostate-specific antigen (PSA) assays at baseline and every 3 months thereafter up to 12 months. Results: After radiation, the mean normalized citrate level (citrate/water) decreased significantly over time, both in the peripheral zone (PZ) (p = 0.0034) and in the entire prostate (p = 0.0008), whereas no significant change was observed in mean normalized choline levels (choline/water) in the PZ (p = 0.84) and in the entire prostate (p = 0.95). At 6 months after radiation, the mean choline level was significantly lower in the PZ for patients with a PSA value of {<=}0.5 ng/mL at 12 months (4.9 {+-} 1.7 vs. 7.1 {+-} 1.5, p = 0.0378). Similar results were observed at 12 months in the PZ (6.2 {+-} 2.3 vs. 11.4 {+-} 4.1, p = 0.0117 for choline level and 3.4 {+-} 0.7 vs. 16.1 {+-} 6.1, p = 0.0054 for citrate level) and also in the entire prostate (6.2 {+-} 1.9 vs. 10.4 {+-} 3.2, p = 0.014 for choline level and 3.0 {+-} 0.8 vs. 13.3 {+-} 4.7, p = 0.0054 for citrate level). For patients receiving LTHT, there was no correlation between choline or citrate levels and PSA value, either at baseline or at follow-up. Conclusions: Low normalized choline in the PZ, 6 months after radiation, predicts which patients attained a PSA {<=}0.5 ng/mL at 1 year. Further analyses with longer follow-up times are warranted to determine whether or not these new biomarkers can conclusively predict the early radiation response and the

  20. Clinical outcomes of management of myofacial pain dysfunction syndrome.

    PubMed

    Khatun, S; Huq, M Z; Islam, M A; Uddin, M W; Asaduzzaman, M; Hossain, M M

    2012-04-01

    The purpose of the present study was to investigate two years clinical outcome of patients having myofacial pain dysfunction syndrome (MPDS). A total of 50 patients (male: 15, Female: 35, age: raged from 20 to 65 years) were included for this study. Clinical diagnosis for the assessment of anxiety and depression of each patient was performed by Hospital anxiety and depression (HAD) scale. Patients were then received either one of the following treatments: Occlusion correction only (n=14), Muscle Relaxant + anti-depressant drug (n=26), Physiotherapy + antidepressant drug + muscle relaxant (n=6) and Appliance + muscle relaxant (n= 4). Following two years observation, it was revealed that the treatment was apparently successful in 95% case; only 5% case was not successful due to their irregular visit. It can be concluded that MPDS is not primarily related to occlusal factors and a complex psycho physiological mechanism is involved in this type of pain problems.

  1. The bleeding score predicts clinical outcomes and replacement therapy in adults with von Willebrand disease.

    PubMed

    Federici, Augusto B; Bucciarelli, Paolo; Castaman, Giancarlo; Mazzucconi, Maria G; Morfini, Massimo; Rocino, Angiola; Schiavoni, Mario; Peyvandi, Flora; Rodeghiero, Francesco; Mannucci, Pier Mannuccio

    2014-06-26

    Analyses of the bleeding tendency by means of the bleeding score (BS) have been proposed until now to confirm diagnosis but not to predict clinical outcomes in patients with inherited von Willebrand disease (VWD). We prospectively followed up, for 1 year, 796 Italian patients with different types of VWD to determine whether the previous BS of European VWD1 is useful to predict the occurrence of spontaneous bleeds severe enough to require replacement therapy with desmopressin (DDAVP) and/or von Willebrand factor (VWF)/factor VIII concentrates. Among the 796 patients included, 75 (9.4%) needed treatment of 232 spontaneous bleeding events. BS >10 and VWF:ristocetin cofactor activity <10 U/dL were associated with the risk of bleeding, but only a BS >10 remained highly associated in a multivariable Cox proportional hazard model (adjusted hazard ratio: 7.27 [95% confidence interval, 3.83-13.83]). Although the bleeding event-free survival was different in VWD types, only a BS >10 could predict for each type which patient had bleeding events severe enough to require treatment with DDAVP and/or concentrates. Therefore, BS can be considered a simple predictor of clinical outcomes of VWD and may identify patients needing intensive therapeutic regimens.

  2. Short-Term Clinical Result of Cortical Bone Trajectory Technique for the Treatment of Degenerative Lumbar Spondylolisthesis with More than 1-Year Follow-Up

    PubMed Central

    Nishizawa, Kazuya; Nakamura, Akira; Imai, Shinji

    2016-01-01

    Study Design Retrospective follow-up study on the result of surgical treatment for patients with degenerative lumbar spondylolisthesis (DLS) using cortical bone trajectory (CBT) technique. Purpose To evaluate the capability of CBT to manage patients with DLS. Overview of Literature CBT is a recently advocated, novel, less-invasive technique of lumbar pedicle screw, which provides enhanced screw purchase by maximizing the thread contact with higher density bone surface. Despite the frequent use of CBT technique in the lumbar spine surgery, little is known of the capability of this technique to manage patients with DLS. Methods Thirty two consecutive patients (5 males, 27 females) surgically treated with single-level DLS in our institute using CBT were included. All patients were followed up at least 12 months (mean 24 months). Their clinical and radiological features were measured. Results Good leg pain relief was achieved in all patients. The mean postoperative percentage slip demonstrated significant reduction with significant neurological recovery when compared with preoperative percentage slip, and it was maintained until the latest follow-up. Loss of correction of more than 3 mm during the follow-up period was observed in 3 cases. Surgical site infection was observed in one case; however, pull-out of PSs or neurological deterioration was not found. No patient needed additional surgery during the follow-up period. Conclusions These preliminary results confirmed that CBT is useful for the treatment for patients with DLS. This technique allows good reduction of spondylolisthesis and neurological improvement. PMID:27114763

  3. Reflections 1 year into the 21-Center National Institutes of Health--funded WRIST study: a primer on conducting a multicenter clinical trial.

    PubMed

    2013-06-01

    The Wrist and Radius Injury Surgery Trial (WRIST) study group is a collaboration of 21 hand surgery centers in the United States, Canada, and Singapore, to showcase the interest and capability of hand surgeons to conduct a multicenter clinical trial. The WRIST study group was formed in response to the seminal systematic review by Margaliot et al and the Cochrane report that indicated marked deficiency in the quality of evidence in the distal radius fracture literature. Since the initial description of this fracture by Colles in 1814, over 2,000 studies have been published on this subject; yet, high-level studies based on the principles of evidence-based medicine are lacking. As we continue to embrace evidence-based medicine to raise the quality of research, the lessons learned during the organization and conduct of WRIST can serve as a template for others contemplating similar efforts. This article traces the course of WRIST by sharing the triumphs and, more important, the struggles faced in the first year of this study.

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

    PubMed

    Linden, W

    1994-09-01

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

  5. 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

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

    PubMed

    Massof, Robert W

    2010-01-01

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

  7. Laryngotracheal stenosis: clinical profile, surgical management and outcome.

    PubMed

    Pookamala, S; Kumar, Rakesh; Thakar, Alok; Venkata Karthikeyan, C; Bhalla, Ashu Seith; Deka, R C

    2014-01-01

    Despite the availability of various surgical options, management of laryngotracheal stenosis (LTS) still remains an enigma. Proper selection of surgical technique in each clinical setting is the key for successful outcome. The purpose of this article is to guide one in selection of appropriate surgical procedures depending upon various stenosis parameters. Aim To record the clinical profile of cases with LTS. To assess the outcome following various surgical interventions based on site, severity, cause of stenosis and to derive conclusions regarding treatment options in various stenosis. Materials and Methods It is a study of 60 cases with chronic LTS. It includes retrospective study of 30 cases treated from 2004 and prospective study of 30 cases from Jan 2007 to Dec 2009. A total of 60 cases with LTS were enrolled in the study. Patients were assessed clinically by eliciting detailed history and analyzing previous records. After assessment of extent of stenosis, they were subjected to surgical interventions (endoscopic/open approach). Outcome after surgical interventions was assessed. Results 60 patients were included in the study, in the age group of 2.5-50 years. There were 46 (77%) male patients and 14 (23%) female patients. Intrinsic trauma, secondary to prolonged intubation was the most common cause of LTS, seen in 23 (38%) cases followed by post traumatic stenosis (strangulation-18 (30%), blunt injury-15 (25%), penetrating neck injury-4 (7%)). Stenosis was divided into 6 types based on subsite involvement. Of which, cervical trachea was the commonest site of involvement (25/60 cases). Majority of cases had fixed vocal cords at presentation (55%), more commonly due to post traumatic injury. 60 cases had undergone a total of 110 surgical procedures (endoscopic-56,open approach-54). In the end, overall decannulation rate is 93.3%. In site wise tracheal stenosis, isolated subglottis, combined glottis and subglottic stenosis had decannulation rate of 100% each and

  8. Clinical presentation and outcome of venous thromboembolism in COPD.

    PubMed

    Bertoletti, L; Quenet, S; Mismetti, P; Hernández, L; Martín-Villasclaras, J J; Tolosa, C; Valdés, M; Barrón, M; Todolí, J A; Monreal, M

    2012-04-01

    Chronic obstructive pulmonary disease (COPD) is a moderate risk factor for venous thromboembolism (VTE), but neither the clinical presentation nor the outcome of VTE in COPD patients is well known. The clinical presentation of VTE, namely pulmonary embolism (PE) or deep venous thrombosis (DVT), and the outcome at 3 months (death, recurrent VTE or bleeding) were compared between 2,984 COPD patients and 25,936 non-COPD patients included in the RIETE (Registro Informatizado de la Enfermedad TromboEmbólica) registry. This ongoing international, multi-centre registry includes patients with proven symptomatic PE or DVT. PE was the more frequent VTE presentation in COPD patients (n = 1,761, 59%). PE presentation was more significantly associated with COPD patients than non-COPD patients (OR 1.64, 95% CI 1.49-1.80). During the 3-month follow-up, mortality (10.8% versus 7.6%), minor bleeding (4.5% versus 2.3%) or first VTE recurrences as PE (1.5% versus 1.1%) were significantly higher in COPD patients than in non-COPD patients. PE was the most common cause of death. COPD patients presented more frequently with PE than DVT. It may explain the worse prognosis of COPD patients, with a higher risk of death, bleeding or VTE recurrences as PE compared with non-COPD patients. Further therapeutic options are needed.

  9. Clinical and Microbiological Determinants of Outcome in Staphylococcus aureus Bacteraemia.

    PubMed

    Price, James; Baker, Gillian; Heath, Ian; Walker-Bone, Karen; Cubbon, Marc; Curtis, Sally; Enright, Mark C; Lindsay, Jodi; Paul, John; Llewelyn, Martin

    2010-01-01

    Staphylococcus aureus bacteraemia (SAB) is commonly complicated by metastatic infection or relapse after treatment. Objectives. The study aim was to determine the role of bacterial, host, and management factors in development of complicated SAB. Methods. A prospectively-conducted observational study gathered data on predisposition, management and outcome of 100 consecutive SAB cases. Antibiotic susceptibilities and genetic lineage of bacterial isolates were determined. Further clinical and microbiological data were gathered on two retrospective series from 1999-2000 (n = 57) and 2004 (n = 116). Results. In the prospective cases, 27% met our definition of complicated disease. Expressed as RR and 95% CI, complicated disease was associated with diabetes (1.58, 1.00-2.48), injecting-drug use (5.48, 0.88-33.49), community-onset of symptoms (1.4, 1.02-1.92), and symptom duration >/=48 hours prior to starting effective antibiotic therapy (2.10, 1.22-3.61). Uncomplicated disease was associated with the presence of a central line (0.69, 0.55-0.88) and prompt removal of a primary focus (0.71, 0.57-0.90). Neither methicillin resistance nor genetic lineage was associated with complicated disease, but methicillin resistance was associated with higher mortality. Conclusions. This study demonstrates that clinical rather than microbial factors are the major determinants of SAB outcome and underscores the importance of early treatment.

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

    PubMed Central

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

    2017-01-01

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

  11. Outcome Measures for Clinical Drug Trials in Autism

    PubMed Central

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

    2015-01-01

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

  12. Clinical Outcome in Singleton and Multiple Pregnancies with Placental Chorangioma

    PubMed Central

    Sirotkina, Meeli; Douroudis, Konstantinos; Papadogiannakis, Nikos; Westgren, Magnus

    2016-01-01

    Introduction Chorangiomas (CAs) are the most common non-trophoblastic tumor-like-lesions of the placenta. Although the clinical significance of small CAs is unknown, the large lesions are often associated with maternal and fetal complications. The aim of our study was to assess the maternal clinical characteristics and neonatal outcome in singleton and multiple pregnancies with placental CA. Materials and Methods Among 15742 selected placentas 170 CAs were diagnosed. Pregnancy and neonatal outcomes were analyzed in singleton (n = 121) and multiple (n = 49) pregnancy groups including 121 and 100 neonates, respectively. Results The frequency of APGAR score <7 at 5 minutes (p = 0,012), abnormal pulsatility index (p = 0,034), and abnormal blood flow class (p = 0,011) were significantly higher in neonates from singleton compared to multiple pregnancies. Significantly smaller CAs in singleton pregnancies were related to small for gestational age neonates (p = 0,00040) and neonates admitted to the neonatal care unit (p = 0,028). In singleton pregnancies, significantly smaller CAs were associated to maternal preeclampsia (p = 0,039) and larger CAs to multiparity (p = 0,005) and smoking (p = 0,001) groups. The frequency of preeclampsia was high in both singleton and multiple pregnancy groups (41,32% vs 26,53%, respectively), however, the difference did not reach the level of statistical significance. Discussion A high incidence of preeclampsia in cohort of placental CA might lead to a possible recognition of CAs as potential morphologic indicator of placental hypoxia. Conclusion A more favorable pregnancy outcome in multiple gestations compared to the singleton gestations with CAs might reflect an adaptive mechanism for increased demand of oxygen and associated placental tissue hypoxia in this group. PMID:27835686

  13. Alpine Skiing With total knee ArthroPlasty (ASWAP): clinical and radiographic outcomes.

    PubMed

    Hofstaedter, T; Fink, C; Dorn, U; Pötzelsberger, B; Hepperger, C; Gordon, K; Müller, E

    2015-08-01

    The aim of the study was to assess the effect of a recreational alpine skiing intervention on implant-related factors, such as loosening and wear, in patients with total knee arthoplasty (TKA). A group of 16 TKA patients were examined 2.3 ± 0.1 years after skiing about 80 days over three seasons inclusive of a ski intervention of 2-3 times per week (25.5 days) over a 12-week period. Mean follow-up period was 5.1 ± 1 years after surgery. All patients had excellent clinical and radiological outcomes. The average flexion was 120-130°, the average Oxford Knee Score increased from 15 points pre-operatively to 47.4 points post-operatively. An average Tegner activity level of 5.5 was assessed, indicating a very high post-operative activity level. No radiolucencies or osteolyses were observed in any of the radiographs. One patient sustained a meniscal tear in the contralateral knee. Recreational alpine skiing on intermediate terrain at moderate speed can be recommended after TKA. Analysis of mid-term follow-up has not shown any negative effect on the implant loosening or additional polyethylene wear.

  14. 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

  15. Social Development: 1 Year Olds

    MedlinePlus

    ... Stages Listen Español Text Size Email Print Share Social Development: 1 Year Olds Page Content Article Body During his second year, your toddler will develop a very specific image of his social world, friends, and acquaintances. He ...

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

    PubMed

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

    2012-05-01

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

  17. 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.

  18. Clinical outcomes of subtotal cholecystectomy performed for difficult cholecystectomy

    PubMed Central

    Shin, Minho; Choi, Namkyu; Yoo, Youngsun; Kim, Yooseok; Kim, Sungsoo

    2016-01-01

    Purpose Laparoscopic subtotal cholecystectomy (LSC) can be an alternative surgical technique for difficult cholecystectomies. Surgeons performing LSC sometimes leave the posterior wall of the gallbladder (GB) to shorten the operation time and avoid liver injury. However, leaving the inflamed posterior GB wall is a major concern. In this study, we evaluated the clinical outcomes of standard laparoscopic cholecystectomy (SLC), LSC, and LSC removing only anterior wall of the GB (LSCA). Methods We retrospectively reviewed the medical records of laparoscopic cholecystectomies performed between January 2006 to December 2015 and analyzed the outcomes of SLC, LSC, and LSCA. Results A total of 1,037 patients underwent SLC. 22 patients underwent LSC; and 27 patients underwent LSCA. The mean operating times of SLC, LSC, and LSCA were 41, 74, and 68 minutes, respectively (P < 0.01). Blood loss was 5, 45, and 33 mL (P < 0.05). The mean lengths of postoperative hospitalization were 3.4, 5.4, and 5.8 days. Complications occurred in 24 SLC patients (2.3%), 2 LSC patients (9%), and 1 LSCA patient (3.7%). There was no mortality among the LSC and LSCA patients. Conclusion LSC and LSCA are safe and feasible alternatives for difficult cholecystectomies. These procedures help surgeons avoid bile duct injury and conversion to laparotomy. LSCA has the benefits of shorter operation time and less bleeding compared to LSC. PMID:27847794

  19. Preterm birth in twin pregnancies: Clinical outcomes and predictive parameters

    PubMed Central

    Dolgun, Zehra Nihal; Inan, Cihan; Altintas, Ahmet Salih; Okten, Sabri Berkem; Sayin, Niyazi Cenk

    2016-01-01

    Objective: To document the neonatal outcomes of preterm birth in twin pregnancies and to investigate whether perinatal and obstetric parameters are associated with clinical outcomes. Methods: This retrospective trial was conducted on data gathered from 176 preterm twins delivered in the obstetrics and gynecology department of our tertiary care center. Data extracted from medical files of 88 pregnant women who gave preterm birth (at 260/7 to 366/7 gestational weeks) to twins were analyzed. Maternal/fetal descriptive and obstetric parameters, sonographic data, route of delivery, indication for cesarean section, birth weight, Apgar scores, head circumference, umbilical cord length and placental weight were noted. Results: The average age of the pregnant women was 28.8±6.4 years and ultrasonographic gestational age was 31.9±2.6 weeks. Apgar scores at 1st minute were affected significantly by fetal body weight (p=0.001), gestational age (p=0.001), height (p=0.004) and head circumference (p=0.011). None of these variables exhibited a noteworthy effect on Apgar scores at 5th minute. Conclusion: Efforts must be made to achieve advancement of gestational age until delivery in the follow-up preterm of twins. A well-established algorithm with special emphasis to risk factors is necessary to standardize and popularize the appropriate management strategy. PMID:27648040

  20. Patient reported outcomes and patient empowerment in clinical genetics services.

    PubMed

    McAllister, M; Dearing, A

    2015-08-01

    Evaluation of clinical genetics services (CGS), including genetic counseling and genetic testing, has been problematic. Patient mortality and morbidity are unlikely to be directly improved by interventions offered in CGS. Patient-reported outcomes (PROs) are not routinely measured in CGS evaluation, but this may change as patient-reported outcome measures (PROMs) become a key part of how healthcare services are managed and funded across the world. However, there is no clear consensus about which PROMs are most useful for CGS evaluation. This review summarizes the published research on how PROs from CGS have been measured and how patients may benefit from using those services, with a focus on patient empowerment. Many patient benefits (PROs) identified repeatedly in the research literature can be re-interpreted within a patient empowerment framework. Other important PROs identified include family functioning, social functioning, altruism, sense of purpose, enabling development of future research and treatment/participating in research. Well-validated measures are available to capture (dimensions of) patient empowerment. Although generic measures of family functioning are available, suitable measures capturing social functioning, development of future treatments, and altruism were not identified in this review. Patient empowerment provides one useful approach to measuring PROs from CGS.

  1. Clinical features and outcome of severe malaria in Gambian children.

    PubMed

    Waller, D; Krishna, S; Crawley, J; Miller, K; Nosten, F; Chapman, D; ter Kuile, F O; Craddock, C; Berry, C; Holloway, P A

    1995-09-01

    The clinical and laboratory features of severe falciparum malaria in 180 Gambian children were studied between 1985 and 1989. Of the 180 children, 118 (66%) presented with seizures, 77 (43%) had cerebral malaria, 35 (20%) had witnessed seizures after admission, 29 (16%) were hypoglycemic, and 27 (15%) died. Respiratory distress was a common harbinger of a fatal outcome. The differences in admission parasite counts in the blood, hematocrit, and opening cerebrospinal pressures for patients who died and survivors were not significant. A multiple logistic regression model identified neurological status (coma, particularly if associated with extensor posturing), stage of parasite development on the peripheral blood film, pulse rate of > 150 or respiratory rate of > 50, hypoglycemia, and hyperlactatemia (plasma lactate level, > 5 mmol/L) as independent indicators of a fatal outcome. Biochemical evidence of hepatic and renal dysfunction was an additional marker of a poor prognosis, but, in contrast to severe malaria in adults, none of these children with severe malaria had acute renal failure.

  2. 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

  3. 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

  4. Clinical Outcomes of Lung Transplantation in Patients with Telomerase Mutations

    PubMed Central

    Tokman, Sofya; Singer, Jonathan P.; Devine, Megan S.; Westall, Glen P.; Aubert, John-David; Tamm, Michael; Snell, Gregory I.; Lee, Joyce S.; Goldberg, Hilary J.; Kukreja, Jasleen; Golden, Jeffrey A.; Leard, Lorriana E.; Garcia, Christine K.; Hays, Steven R.

    2017-01-01

    Background Successful lung transplantation (LT) for patients with pulmonary fibrosis from telomerase mutations is limited by systemic complications of telomerase dysfunction including myelosuppression, cirrhosis, and malignancy. We describe clinical outcomes among 14 LT recipients with telomerase mutations. Methods Subjects underwent LT between February 2005 and April 2014 at 5 LT centers. We abstracted data from medical records, focusing on outcomes reflecting post-LT treatment effects likely to be complicated by telomerase mutations. Results The median age of subjects was 60.5 years (IQR 52.0–62.0), 64.3% were male, and the mean post-LT observation time was 3.2 years (SD ±2.9). Eleven subjects had a mutation in telomerase reverse transcriptase, 2 in telomerase RNA component, and 1 had an uncharacterized mutation. Ten subjects were leukopenic post-LT; leukopenia prompted cessation of mycophenolate mofetil in 5 and treatment with filgrastim in 4. Six subjects had recurrent lower respiratory tract infections (LRTI), 7 had acute cellular rejection (ACR) (A1), and 4 developed chronic lung allograft dysfunction (CLAD). Ten LT recipients developed chronic renal insufficiency and 8 experienced acute, reversible renal failure. Three developed cancer, none had cirrhosis. Thirteen subjects were alive at data censorship. Conclusions The clinical course for LT recipients with telomerase mutations is complicated by renal disease, leukopenia prompting a change in the immunosuppressive regimen, and recurrent LTRI. In contrast, cirrhosis was absent, ACR was mild, and development of CLAD was comparable to other LT populations. While posing challenges, lung transplantation may be feasible for patients with pulmonary fibrosis due to telomerase mutations. PMID:26169663

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

    PubMed

    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.

  6. Social Influences on Clinical Outcomes of Patients With Ovarian Cancer

    PubMed Central

    Lutgendorf, Susan K.; De Geest, Koen; Bender, David; Ahmed, Amina; Goodheart, Michael J.; Dahmoush, Laila; Zimmerman, M. Bridget; Penedo, Frank J.; Lucci, Joseph A.; Ganjei-Azar, Parvin; Thaker, Premal H.; Mendez, Luis; Lubaroff, David M.; Slavich, George M.; Cole, Steven W.; Sood, Anil K.

    2012-01-01

    Purpose Previous research has demonstrated relationships of social support with disease-related biomarkers in patients with ovarian cancer. However, the clinical relevance of these findings to patient outcomes has not been established. This prospective study examined how social support relates to long-term survival among consecutive patients with ovarian cancer. We focused on two types of social support: social attachment, a type of emotional social support reflecting connections with others, and instrumental social support reflecting the availability of tangible assistance. Patients and Methods Patients were prospectively recruited during a presurgical clinic visit and completed surveys before surgery. One hundred sixty-eight patients with histologically confirmed epithelial ovarian cancer were observed from the date of surgery until death or December 2010. Clinical information was obtained from medical records. Results In a Cox regression model, adjusting for disease stage, grade, histology, residual disease, and age, greater social attachment was associated with a lower likelihood of death (hazard ratio [HR], 0.87; 95% CI, 0.77 to 0.98; P = .018). The median survival time for patients with low social attachment categorized on a median split of 15 was 3.35 years (95% CI, 2.56 to 4.15 years). In contrast, by study completion, 59% of patients with high social attachment were still alive after 4.70 years. No significant association was found between instrumental social support and survival, even after adjustment for covariates. Conclusion Social attachment is associated with a survival advantage for patients with ovarian cancer. Clinical implications include the importance of screening for deficits in the social environment and consideration of support activities during adjuvant treatment. PMID:22802321

  7. Gait Asymmetries Persist 1 Year After Anterior Cruciate Ligament Reconstruction

    PubMed Central

    White, Kathleen; Logerstedt, David; Snyder-Mackler, Lynn

    2013-01-01

    Background: After anterior cruciate ligament reconstruction (ACLR), motivation to return to previous levels of activity is high. Very few studies have used return-to-activity criteria to determine when to permit athletic play. Return-to-activity measures objectively evaluate functional limb symmetry; however, previous biomechanical studies have found gait deviations in these individuals that persist up to 2 years after surgery. Purpose: To evaluate gait biomechanics in a specific cohort of ACL patients 1 year after surgery and retrospectively compare individuals who pass return-to-activity criteria 6 months after surgery with those who fail. Study Design: Prospective analysis. Methods: A total of 40 athletes who participated regularly (>50 h/y) in cutting, jumping, and pivoting activities and who sustained an isolated, unilateral ACL rupture were included in this study. All participants underwent reconstruction by the same surgeon and received individualized postoperative rehabilitation. Performance-based and self-report data were measured 6 months after surgery to assess readiness to return to activity (90% outcome required to pass); 20 subjects passed return-to-activity criteria and 20 subjects did not. Motion analysis was performed 1 year after surgery, and knee flexion angles, moments, and excursions were measured during gait and evaluated for all subjects. Results: There was no limb × group interaction or effect of group for all measures. Decreased knee measures were seen on the involved limb compared with the uninvolved limb for all subjects, and failed subjects demonstrated larger differences between limbs. Conclusion: Patients continued to demonstrate biomechanical limb asymmetries 1 year after ACLR, regardless of performance-based measures at 6 months. Early return to activity did not ensure limb symmetry at 1 year. Clinical Relevance: Gait asymmetries were seen in all subjects 1 year after surgery regardless of status at 6 months. Potentially prolonging

  8. Identification and Use of Frailty Indicators from Text to Examine Associations with Clinical Outcomes Among Patients with Heart Failure

    PubMed Central

    Shao, Yijun; Mohanty, April F.; Ahmed, Ali; Weir, Charlene R.; Bray, Bruce E.; Shah, Rashmee U.; Redd, Douglas; Zeng-Treitler, Qing

    2016-01-01

    Frailty is an important health outcomes indicator and valuable for guiding healthcare decisions in older adults, but is rarely collected in a quantitative, systematic fashion in routine healthcare. Using a cohort of 12,000 Veterans with heart failure, we investigated the feasibility of topic modeling to identify frailty topics in clinical notes. Topics were generated through unsupervised learning and then manually reviewed by an expert. A total of 53 frailty topics were identified from 100,000 notes. We further examined associations of frailty with age-, sex-, and Charlson Comorbidity Index-adjusted 1-year hospitalizations and mortality (composite outcome) using logistic regression. Frailty (≤ 4 topics versus <4) was associated with twice the risk of the composite outcome, Odds Ratio: 2.2, 95% Confidence Interval: (2.0-2.4). This study demonstrates the feasibility of identifying frailty indicators from clinical notes and linking these to clinically relevant outcomes. Future work includes integrating frailty indicators into validated predictive tools. PMID:28269908

  9. 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.

  10. 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

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

    PubMed

    Olupot-Olupot, Peter

    2015-03-01

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

  12. 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

  13. High blood pressure in acute ischemic stroke and clinical outcome.

    PubMed

    Manabe, Yasuhiro; Kono, Syoichiro; Tanaka, Tomotaka; Narai, Hisashi; Omori, Nobuhiko

    2009-11-16

    This study aimed to evaluate the prognostic value of acute phase blood pressure in patients with acute ischemic stroke by determining whether or not it contributes to clinical outcome. We studied 515 consecutive patients admitted within the first 48 hours after the onset of ischemic strokes, employing systolic and diastolic blood pressure measurements recorded within 36 hours after admission. High blood pressure was defined when the mean of at least 2 blood pressure measurements was ≥200 mmHg systolic and/or ≥110 mmHg diastolic at 6 to 24 hours after admission or ≥180 mmHg systolic and/or ≥105 mmHg diastolic at 24 to 36 hours after admission. The high blood pressure group was found to include 16% of the patients. Age, sex, diabetes mellitus, hypercholesterolemia, atrial fibrillation, ischemic heart disease, stroke history, carotid artery stenosis, leukoaraiosis, NIH Stroke Scale (NIHSS) on admission and mortality were not significantly correlated with either the high blood pressure or non-high blood pressure group. High blood pressure on admission was significantly associated with a past history of hypertension, kidney disease, the modified Rankin Scale (mRS) on discharge and the length of stay. On logistic regression analysis, with no previous history of hypertension, diabetes mellitus, atrial fibrillation, and kidney disease were independent risk factors associated with the presence of high blood pressure [odds ratio (OR), 1.85 (95% confidence interval (CI): 1.06-3.22), 1.89 (95% CI: 1.11-3.22), and 3.31 (95% CI: 1.36-8.04), respectively]. Multi-organ injury may be presented in acute stroke patients with high blood pressure. Patients with high blood pressure had a poor functional outcome after acute ischemic stroke.

  14. Clinical outcomes of transfusion-associated iron overload in patients with refractory chronic anemia

    PubMed Central

    Gao, Chong; Li, Li; Chen, Baoan; Song, Huihui; Cheng, Jian; Zhang, Xiaoping; Sun, Yunyu

    2014-01-01

    Background The purpose of this study was to evaluate the clinical outcomes of transfusion-associated iron overload in patients with chronic refractory anemia. Methods Clinical manifestations, main organ function, results of computed tomography (CT), endocrine evaluation, and serum ferritin levels were analyzed retrospectively in 13 patients who were transfusion-dependent for more than 1 year (receiving >50 units of red blood cells) to determine the degree of iron overload and efficacy of iron-chelating therapy. Results Serum ferritin levels increased to 1,830–5,740 ng/mL in all patients. Ten patients had abnormal liver function. The CT Hounsfield units in the liver increased significantly in eleven patients, and were proportional to their serum ferritin levels. Skin pigmentation, liver dysfunction, and endocrine dysfunction were observed in nine patients with serum ferritin >3,500 ng/mL, eight of whom have since died. Interestingly, serum ferritin levels did not decrease significantly in nine transfusion-dependent patients who had received 15–60 days of iron-chelating therapy. Conclusion Transfusion-dependent patients may progress to secondary iron overload with organ impairment, which may be fatal in those who are heavily iron-overloaded. The CT Hounsfield unit is a sensitive indicator of iron overload in the liver. Iron chelation therapy should be initiated when serum ferritin is >1,000 ng/mL and continued until it is <1,000 ng/mL in transfusional iron-overloaded patients. PMID:24790419

  15. Language Development: 1 Year Olds

    MedlinePlus

    ... Stages Listen Español Text Size Email Print Share Language Development: 1 Year Olds Page Content Article Body ... assured, it’s not your imagination. He’s developing his language and comprehension skills right on schedule. This giant ...

  16. Clinical Outcomes of Enterobacteriaceae Infections Stratified by Carbapenem MICs

    PubMed Central

    Patel, Twisha S.

    2014-01-01

    The Clinical and Laboratory Standards Institute (CLSI) lowered the MIC breakpoints for meropenem and imipenem from 4 mg/liter to 1 mg/liter for Enterobacteriaceae in 2010. The breakpoint change improves the probability of pharmacodynamic target attainment and eliminates the need for microbiology labs to perform confirmatory testing for Klebsiella pneumoniae carbapenemase (KPC) production or other beta-lactamases that hydrolyze carbapenems. However, there are limited data evaluating clinical outcomes of the affected breakpoints, and it is unknown if patients infected with Enterobacteriaceae with reduced susceptibility are more likely to have poor outcomes when treated with a carbapenem. We conducted a single-center retrospective matched-cohort analysis in adult patients with Enterobacteriaceae infections treated with meropenem, imipenem, or doripenem. Patients with Enterobacteriaceae infection with a carbapenem MIC of 2 to 8 mg/liter were matched based on pathogen, source of infection, comorbidities, and disease severity (1:1 ratio) to those with a carbapenem MIC of ≤1 mg/liter. A total of 36 patients were included in the study. The group with carbapenem MICs of 2 to 8 mg/liter had a significantly higher 30-day mortality than the group with carbapenem MICs of ≤1 mg/liter (38.9% compared to 5.6%, P = 0.04). Total hospital length of stay (LOS) and intensive care unit (ICU) LOS were longer in the group with MICs of 2 to 8 mg/liter than in the group with MICs of ≤1 mg/liter (57.6 days compared to 34.4 days [P = 0.06] and 56.6 days compared to 21.7 days [P < 0.01], respectively). Patients infected with Enterobacteriaceae with a carbapenem MIC of 2, 4, or 8 mg/liter had higher mortality rates and longer ICU LOS than matched cohorts with carbapenem MICs of ≤1 mg/liter, which supports CLSI's recommendation to lower susceptibility breakpoints for carbapenems. PMID:25378572

  17. 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

  18. Clinical characteristics and treatment outcomes among patients with tuberculosis in Bangkok and Nonthaburi, Thailand.

    PubMed

    Manosuthi, Weerawat; Kawkitinarong, Kamon; Suwanpimolkul, Gompol; Chokbumrungsuk, Channarong; Jirawattanapisal, Thidaporn; Ruxrungtham, Kiat; Akksilp, Somsak

    2012-11-01

    Tuberculosis (TB) is a public health problem in many large cities. We retrospectively studied the clinical characteristics and treatment outcomes of patients with active TB at 6 hospitals in Bangkok and Nonthaburi, Thailand during 2008-2009. Eight hundred thirteen patients were included in the study. The mean age of subjects +/- SD was 41 +/- 14 years and mean body weight +/- SD was 53 +/- 11 kilograms. The three leading co-morbid conditions were HIV infection (40%), diabetes (6%) and chronic liver disease (2%). Two-thirds of subjects had isolated pulmonary TB. Isoniazid, rifampicin and multi-drug resistance were seen in 13, 7 and 5%, respectively. After 1 year, 52% were cured or completed treatment, 19% transferred out, 12% defaulted, 9% were still on-going TB treatment, 7% had died and 1% had failed treatment. Survival rates at 2, 6 and 12 months were 93, 85 and 81% among HIV seropositive subjects; 96, 94 and 92% among HIV seronegative subjects and 98, 97 and 97% among subjects with unknown HIV status (p < 0.001). On multivariate analysis, death was associated with: TB/HIV co-infection (HR 2.8; 95% CI 1.6-5.0), low body weight (HR 1.6; 95% CI 1.2-2.3), being elderly (HR 1.4; 95% CI 1.1-1.8) and having extrapulmonary/disseminated TB (HR 2.2; 95% CI 1.1-4.2). HIV infection and diabetes were the most common co-morbidities among TB subjects in our study. The percent of patients with unfavorable outcomes was relatively high, particularly among HIV co-infected and elderly subjects. Further effort needs to be made to improve these unfavorable TB outcomes in Nonthaburi and Bangkok, Thailand.

  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. 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.

  1. Systematic review of clinical outcomes after prophylactic surgery

    PubMed Central

    Davis, CR; Trevatt, AEJ; Dixit, A; Datta, V

    2016-01-01

    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

  2. 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

  3. Frameless Image-Guided Intracranial Stereotactic Radiosurgery: Clinical Outcomes for Brain Metastases

    SciTech Connect

    Breneman, John C. Steinmetz, Ryan; Smith, Aaron; Lamba, Michael; Warnick, Ronald E.

    2009-07-01

    Purpose: After preclinical investigations confirming the accuracy of target localization by frameless image-guided radiosurgery, we report the clinical outcomes of patients with brain metastases who underwent frameless radiosurgery. Methods and Materials: Between 2005 and 2006, 53 patients underwent frameless stereotactic radiosurgery using a linear accelerator equipped with on-board image guidance for the treatment of 158 brain metastases. The radiation doses were delivered in a single fraction (dose range, 12-22 Gy; median, 18). Patients were followed with magnetic resonance imaging scans at 2-3-month intervals. Progression-free survival was the primary study endpoint. Results: With a median follow-up of 38 weeks (range, 14-112), the overall survival rate was 70% at 6 months, 44% at 1 year, 29% at 18 months, and 16% at 24 months. Local control was achieved in 90% of 168 treated lesions at 6 months, 80% at 12 months, 78% at 18 months, and 78% at 24 months. Local control tended to be improved in lesions treated with {>=}18 Gy and for lesions <0.2 cm{sup 3}. Adverse events occurred in 5 patients (9.6%). No evidence of imaging changes on post-stereotactic radiosurgery scans was found to suggest mistargeting of a radiation isocenter. Conclusion: The clinical outcomes after frameless stereotactic radiosurgery were comparable to those after frame-based radiosurgery techniques. Given its significant advantages in terms of patient comfort, ability to use fractionated treatment regimens, and convenience in scheduling of personnel and equipment resources, frameless radiosurgery will likely become a common technique for intracranial radiosurgery.

  4. Clinical Outcomes After Cervical Transcorporeal Microdecompression and Vertebral Body Access Channel Repair

    PubMed Central

    Lowry, David W.; Tuinstra, Scott M.; Liang, Kevin

    2015-01-01

    Background Although anterior cervical decompression and fusion (ACDF) can be performed using minimally invasive techniques, the extensive removal of anatomical keystones during decompression requires a segmental fusion to restore biomechanical stability. Treatment with arthrodesis techniques may result in a prolonged recovery time, loss of motion, and the need for further treatment if a pseudarthosis or adjacent segment disease occur. Transcorporeal micro decompression (TCMD) is a newly developed motion sparing, minimally invasive anterior cervical spine decompression procedure that utilizes a small channel through the cervical vertebral body to decompress areas of central or foraminal stenosis while preserving the native disc. Cervical decompression with TCMD can be performed as a stand-alone or hybrid procedure with ACDF at the adjacent levels. This study retrospectively assesses patient based clinical outcome measures in patients treated with TCMD. Methods A retrospective, non-randomized, single-center chart review of single surgeon experience with patients undergoing TCMD both with and without adjacent level ACDF using both a trajectory control guide and access channel repair. Statistical analyses were performed on pre and post-operative data collected using visual analog scale (VAS) and neck disability index (NDI) outcome measures. Results Among 62 patients, there were no cases of neurovascular injury, CSF leak, transfusion, or migration of repair implement. Revision surgery was required in 6.4% (n=4) patients. A subanalysis of outcome metrics was performed for patients that underwent standalone TCMD (TCMD group, n=42) and TCMD with concurrent ACDF at one or more levels (TCMD+ACDF group, n=20). TCMD group NDI improved from 20.0 to 2.7 at 1 year (p=0.0001); Axial VAS improved from 5.5 to 0.6 (p=0.0001); and Radiating VAS improved from 7.0 to 0.7 (p=0.0001). TCMD+ACDF group NDI improved from 22.0 to 4.0 at 1 year (p=0.004); Axial VAS improved from 7.1 to 1.2 (p

  5. Comparison of Survival Outcomes Among Cancer Patients Treated In and Out of Clinical Trials

    PubMed Central

    2014-01-01

    Background Clinical trials test the efficacy of a treatment in a select patient population. We examined whether cancer clinical trial patients were similar to nontrial, “real-world” patients with respect to presenting characteristics and survival. Methods We reviewed the SWOG national clinical trials consortium database to identify candidate trials. Demographic factors, stage, and overall survival for patients in the standard arms were compared with nontrial control subjects selected from the Surveillance, Epidemiology, and End Results program. Multivariable survival analyses using Cox regression were conducted. The survival functions from aggregate data across all studies were compared separately by prognosis (≥50% vs <50% average 2-year survival). All statistical tests were two-sided. Results We analyzed 21 SWOG studies (11 good prognosis and 10 poor prognosis) comprising 5190 patients enrolled from 1987 to 2007. Trial patients were younger than nontrial patients (P < .001). In multivariable analysis, trial participation was not associated with improved overall survival for all 11 good-prognosis studies but was associated with better survival for nine of 10 poor-prognosis studies (P < .001). The impact of trial participation on overall survival endured for only 1 year. Conclusions Trial participation was associated with better survival in the first year after diagnosis, likely because of eligibility criteria that excluded higher comorbidity patients from trials. Similar survival patterns between trial and nontrial patients after the first year suggest that trial standard arm outcomes are generalizable over the long term and may improve confidence that trial treatment effects will translate to the real-world setting. Reducing eligibility criteria would improve access to clinical trials. PMID:24627276

  6. Tuberculosis in African Americans: clinical characteristics and outcome.

    PubMed Central

    Funnyé, A. S.; Ganesan, K.; Yoshikawa, T. T.

    1998-01-01

    This study examined the clinical characteristics and outcome of pulmonary tuberculosis in African Americans hospitalized in a teaching hospital in south-central Los Angeles from May 1992 through April 1994. The charts of 41 African Americans with culture-positive Mycobacterium tuberculosis were reviewed. Predisposing factors for pulmonary tuberculosis were identified in nearly half of cases. Cough and fever were the most common symptoms. Seventy-six percent had positive acid-fast bacilli (AFB) smears. Nine patients were human immunodeficiency virus (HIV)-positive, and 6 of 9 HIV-positive patients had positive AFB smears whereas 17 of 19 HIV-negative patients had positive AFB smears. Radiographic changes were not significantly different between HIV-positive and HIV-negative patients. Drug resistance was identified in nine of 31 patients (29%). Eight of 41 patients (19.5%) died, with 2 being drug resistant. Human immunodeficiency virus infection was a major predisposing factor for tuberculosis, and no statistical differences were found in radiographic features or AFB smear positivity between HIV-positive and HIV-negative patients. Drug resistance and mortality were disproportionately high. These results indicate that HIV infection and drug resistance are major problems that predispose for tuberculosis infection and make its treatment difficult. PMID:9510620

  7. 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.

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

    PubMed

    Stetter, Friedhelm; Kupper, Sirko

    2002-03-01

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

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

    PubMed Central

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

    2016-01-01

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

  10. Influence of renal dysfunction on clinical outcomes in patients with congestive heart failure complicating acute myocardial infarction.

    PubMed

    Kim, Chang Seong; Kim, Min Jee; Kang, Yong Un; Choi, Joon Seok; Bae, Eun Hui; Ma, Seong Kwon; Ahn, Young-Keun; Jeong, Myung Ho; Kim, Young Jo; Cho, Myeong Chan; Kim, Chong Jin; Kim, Soo Wan

    2013-01-01

    The clinical course and medical treatment of patients with congestive heart failure (CHF) complicating acute myocardial infarction (AMI) are not well established, especially in patients with concomitant renal dysfunction. We performed a retrospective analysis of the prospective Korean Acute Myocardial Infarction Registry to assess the medical treatments and clinical outcomes of patients with CHF (Killip classes II or III) complicated by AMI, in the presence or absence of renal dysfunction. Of 13,498 patients with AMI, 2769 (20.5%) had CHF on admission. Compared to CHF patients with preserved renal function, in-hospital mortality and major adverse cardiac events were increased both at 1 month and at 1 year after discharge in patients with renal dysfunction (1154; 41.7%). Postdischarge use of aspirin, betablockers, calcium channel blockers, angiotensin-converting enzyme inhibitors, or angiotensin II receptor blockers and statins significantly reduced the 1-year mortality rate for CHF patients with renal dysfunction; such reduction was not observed for those without renal dysfunction, except in the case of aspirin. Patients with CHF complicating AMI, which is accompanied by renal dysfunction, are at higher risk for adverse cardiovascular outcomes than patients without renal dysfunction. However, they receive fewer medications proven to reduce mortality rates.

  11. A European chart review study on early rheumatoid arthritis treatment patterns, clinical outcomes, and healthcare utilization.

    PubMed

    Emery, Paul; Solem, Caitlyn; Majer, Istvan; Cappelleri, Joseph C; Tarallo, Miriam

    2015-11-01

    This retrospective medical chart review aimed to provide a current, real-world overview of biologic usage in patients with rheumatoid arthritis (RA) in Germany, Spain, and the UK, and estimate clinical and healthcare utilization outcomes associated with early versus late treatment. Adults (≥18 years) with a confirmed RA diagnosis between January 2008 and December 2010, who received biologic treatment for ≥3 months and had ≥12 months of follow-up were included. Early treatment was receipt of biologic agent ≤1 year after RA diagnosis. Outcomes included 28-joint disease activity score (DAS28) reduction of ≥1.2 from biologic start and remission (DAS28 < 2.6). Time to outcome was evaluated using Kaplan-Meier curves and log-rank tests. Of 328 patients enrolled (Germany [n = 111], Spain [n = 106], UK [n = 111]), 58.2 % received early biologic (Germany: 55.0 %, UK: 55.9 %, Spain: 64.2 %; p = 0.321). First-line biologics were more frequent in Spain (26.4 %) and Germany (19.8 %) versus the UK (7.2 %; p < 0.001). Late-treated patients were hospitalized more often than early-treated patients (10.5 vs 2.9 % [p = 0.006] for 9.0 vs 5.4 mean inpatient days [p = 0.408]). DAS28 was 5.1 at biologic initiation (n = 310); 73.5 % of patients had a DAS28 decrease of ≥1.2 and 44.5 % achieved remission. More patients had DAS28 decrease of ≥1.2 (79.2 vs 65.9 %; p = 0.009) and remission (51.1 vs 35.6 %; p = 0.007) with early versus late treatment, with a significant difference in Kaplan-Meier curves when indexing on time since diagnosis (p < 0.001) and biologic start (p = 0.024). In RA patients receiving biologic therapy, over half received biologic therapy early. Early initiation was associated with improved clinical outcomes and reduced hospitalization rates versus late treatment.

  12. Interbody Fusion in Low Grade Lumbar Spondylolsithesis: Clinical Outcome Does Not Correalte with Slip Reduction and Neural Foraminal Dimension

    PubMed Central

    Chatterjee, Atanu; McConnell, Jeffrey R.; Jha, Deepak K.; Chakraburtty, Tapas

    2016-01-01

    Study Design Prospective nonrandomized study. Purpose To find a possible correlation between clinical outcome and extent of lumbar spondylolisthesis reduction. Overview of Literature There is no consensus in the literature concerning whether a beneficial effect of reduction on outcome can be expected following reduction and surgical fusion for low grade lumbar spondylolisthesis. Methods Forty six patients with a mean age of 37.5 years (age, 17–48 years) with isthmic spondylolisthesis underwent interbody fusion with cages with posterior instrumentation (TLIF). Clinical outcome was measured using visual analogue score (VAS) and Oswestry disability index (ODI). Foraminal dimensions and disc heights were measured in standard digital radiographs. These were analyzed at baseline and 1 year after surgery and changes were compared. Radiographic fusion was judged with computed tomography scans at 1 year. Results Ninety percent of the patients had good or very good clinical results with fusion and instrumentation. Baseline and one-year postoperative mean VAS score was 6.33 (range, 5–8) and 0.76 (range, 0–3), respectively (p=0.004). Baseline and one-year postoperative, mean ODI score was 48 (range, 32–62) and 10 (range, 6–16), respectively (p<0.001). A mean spondylolisthesis slip of 32.1% was reduced to 6.7% at 1 year. Average anterior disc height, posterior disc height, vertical foraminal dimension), and foraminal) diameter improved from 9.8 to 11.7 mm (p=0.005), 4.5 to 5.8 mm (p=0.004), 11.3 to 12.6 mm (p=0.002), and 18.6 to 20.0 mm (p<0.001), respectively. The fusion rate was 75% with TLIF. There is no significant correlation between the improvements of ODI scores and the extent of slip reduction. Conclusions Neural decompression and interbody fusion can significantly improve pain and disability but the clinical outcome does not correlate with radiological improvement in the neural foraminal dimension. PMID:27114773

  13. Graded aerobic treadmill testing in pediatric sports-related concussion: safety, clinical use, and patient outcomes.

    PubMed

    Cordingley, Dean; Girardin, Richard; Reimer, Karen; Ritchie, Lesley; Leiter, Jeff; Russell, Kelly; Ellis, Michael J

    2016-12-01

    OBJECTIVE The objectives of this study were 2-fold: 1) to evaluate the safety, tolerability, and clinical use of graded aerobic treadmill testing in pediatric patients with sports-related concussion (SRC), and 2) to evaluate the clinical outcomes of treatment with a submaximal aerobic exercise program in patients with physiological post-concussion disorder (PCD). METHODS The authors conducted a retrospective chart review of pediatric patients (age < 20 years) with SRC who were referred to a multidisciplinary pediatric concussion program and underwent graded aerobic treadmill testing between October 9, 2014, and February 11, 2016. Clinical assessments were carried out by a single neurosurgeon and included clinical history taking, physical examination, and recording specific patient-reported concussion-related symptoms using the Post-Concussion Symptom Scale (PCSS). Graded aerobic treadmill testing using a modified Balke protocol for incremental increases in intensity was used as a diagnostic tool to assess physiological recovery, classify post-concussion syndrome (PCS) subtype, and reassess patients following treatment. Patients with a symptom-limited threshold on treadmill testing (physiological PCD) were treated with an individually tailored submaximal exercise prescription and multidisciplinary targeted therapies. RESULTS One hundred six patients (mean age 15.1 years, range 11-19 years) with SRC underwent a total of 141 treadmill tests. There were no serious complications related to treadmill testing in this study. Overall, 138 (97.9%) of 141 tests were well tolerated and contributed valuable clinical information. Treadmill testing confirmed physiological recovery in 63 (96.9%) of 65 patients tested, allowing successful return to play in 61 (93.8%). Treadmill testing was used to diagnose physiological PCD in 58 patients and cervicogenic PCD in 1 patient. Of the 41 patients with physiological PCD who had complete follow-up and were treated with tailored submaximal

  14. Comparison of Clinical Outcomes Following Acute Myocardial Infarctions in Hypertensive Patients With or Without Diabetes

    PubMed Central

    Lee, Min Goo; Ahn, Youngkeun; Chae, Shung Chull; Hur, Seung Ho; Hong, Taek Jong; Kim, Young Jo; Seong, In Whan; Chae, Jei Keon; Rhew, Jay Young; Chae, In Ho; Cho, Myeong Chan; Bae, Jang Ho; Rha, Seung Woon; Kim, Chong Jim; Choi, Donghoon; Jang, Yang Soo; Yoon, Junghan; Chung, Wook Sung; Cho, Jeong Gwan; Seung, Ki Bae; Park, Seung Jung

    2009-01-01

    Background and Objectives It is thought that patients with diabetes mellitus (DM) have a poor prognosis after an acute myocardial infarction (AMI), but the effect of diabetes on the outcomes of hypertensive patients with AMIs has not been elucidated in the Korean population. The aim of this study was to investigate the effects of diabetes on long-term clinical outcomes following AMIs in patients with hypertension. Subjects and Methods Using data from the Korea Acute Myocardial Infarction Registry (November 2005 to December 2006), 2,233 hypertensive patients with AMIs were grouped as follows based on the presence of DM: group I, diabetic hypertension (n=892, 544 men, mean age=66.2±10.9 years); and group II, non-diabetic hypertension (n=1341, 938 men, mean age=63.9±12.8 years). The primary study outcomes included in-hospital death and major adverse cardiac events (MACE; cardiac death, myocardial infarction (MI), repeat percutaneous coronary intervention, and coronary artery bypass surgery) at the 1 year follow-up. Results Hypertensive patients with DM were older and more likely to be women. The diabetic group had lower blood pressure (p<0.001), a lower left ventricular ejection fraction (p<0.001), a more severe degree of heart failure (p<0.001), a longer duration of coronary care unit admission (p<0.001), and a higher incidence of hyperlipidemia (p=0.007). The N-terminal pro-brain natriuretic peptide level (4602.5±8710.6 pg/mL vs. 2320.8±5837.9 pg/mL, p<0.001) was higher and the creatinine clearance (62.4±29.9 mL/min vs. 73.0±40.8 mL/min, p<0.001) was lower in the diabetic group than the non-diabetic group. Coronary angiographic findings revealed more frequent involvement of the left main stem (p=0.002) and multiple vessels (p<0.001) in the diabetic group. The rate of in-hospital death was higher in the diabetic group (p<0.001). During follow-up, the rates of composite MACE at 1 month, 6 months, and 12 months were higher in the diabetic group (p<0

  15. Important factors in predicting mortality outcome from stroke: findings from the Anglia Stroke Clinical Network Evaluation Study

    PubMed Central

    O. Bachmann, Max; Loke, Yoon Kong; D. Musgrave, Stanley; Price, Gill M.; Hale, Rachel; Metcalf, Anthony Kneale; Turner, David A.; Day, Diana J.; A. Warburton, Elizabeth; Potter, John F.

    2017-01-01

    Abstract Background although variation in stroke service provision and outcomes have been previously investigated, it is less well known what service characteristics are associated with reduced short- and medium-term mortality. Methods data from a prospective multicentre study (2009–12) in eight acute regional NHS trusts with a catchment population of about 2.6 million were used to examine the prognostic value of patient-related factors and service characteristics on stroke mortality outcome at 7, 30 and 365 days post stroke, and time to death within 1 year. Results a total of 2,388 acute stroke patients (mean (standard deviation) 76.9 (12.7) years; 47.3% men, 87% ischaemic stroke) were included in the study. Among patients characteristics examined increasing age, haemorrhagic stroke, total anterior circulation stroke type, higher prestroke frailty, history of hypertension and ischaemic heart disease and admission hyperglycaemia predicted 1-year mortality. Additional inclusion of stroke service characteristics controlling for patient and service level characteristics showed varying prognostic impact of service characteristics on stroke mortality over the disease course during first year after stroke at different time points. The most consistent finding was the benefit of higher nursing levels; an increase in one trained nurses per 10 beds was associated with reductions in 30-day mortality of 11–28% (P < 0.0001) and in 1-year mortality of 8–12% (P < 0.001). Conclusions there appears to be consistent and robust evidence of direct clinical benefit on mortality up to 1 year after acute stroke of higher numbers of trained nursing staff over and above that of other recognised mortality risk factors. PMID:28181626

  16. Intra-arterial nimodipine for cerebral vasospasm after subarachnoid haemorrhage: Influence on clinical course and predictors of clinical outcome

    PubMed Central

    Andresen, Morten; Bartek, Jiri; Cortsen, Marie; Eskesen, Vagn; Wagner, Aase

    2016-01-01

    Intra-arterial nimodipine (IAN) has shown a promising effect on cerebral vasospasm (CV) after aneurysmal subarachnoid haemorrhage. At our institution, Rigshospitalet, IAN treatment has been used since 2009, but the short- and long-term clinical efficacy of IAN has not yet been assessed. The purpose was to evaluate the efficacy and clinical outcome of IAN treatment of symptomatic CV, and to assess the predictors of clinical outcome. Medical records of 25 patients undergoing a total of 41 IAN treatment sessions were retrospectively reviewed. Data on angiographic results, blood-flow velocities and the clinical condition before and after the IAN treatment were recorded. Predictors of the clinical outcome were assessed with a linear regression model. Positive angiographic response was achieved in 95.1% of 41 IAN treatment sessions. Flow-velocity measurements showed no relationship with angiographic responses of IAN. The immediate clinical improvement was observed in three patients (12%). Five patients (20%) had a favourable outcome at discharge and at three-month follow-up; 10 patients (40%) had a moderate to poor outcome; and the rest (40%) died. Increased number of affected vessels and number of procedures carried out per patient, and a trend toward an increased delay time from symptomatic CV to confirming angiographic CV and thus instituting IAN treatment predicted the poor clinical outcome. IAN treatment appears to be effective in reversing angiographic CV. However, it is not always effective in reversing clinical deterioration, as several other factors including treatment delay affect the clinical course. PMID:26825134

  17. Elevated Patient Body Mass Index Does Not Negatively Affect Self-Reported Outcomes of Thoracolumbar Surgery: Results of a Comparative Observational Study with Minimum 1-Year Follow-Up.

    PubMed

    Manson, Neil A; Green, Alana J; Abraham, Edward P

    2016-03-01

    Study Design Retrospective study. Objective Quantify the effect of obesity on elective thoracolumbar spine surgery patients. Methods Five hundred consecutive adult patients undergoing thoracolumbar spine surgery to treat degenerative pathologies with minimum follow-up of at least 1 year were included. Primary outcome measures included Numerical Rating Scales for back and leg pain, the Short Form 36 Physical Component Summary and Mental Component Summary, the modified Oswestry Disability Index, and patient satisfaction scores collected preoperatively and at 3, 6, 12, and 24 months postoperatively. Secondary outcome measures included perioperative and postoperative adverse events, postoperative emergency department presentation, hospital readmission, and revision surgeries. Patients were grouped according to World Health Organization body mass index (BMI) guidelines to isolate the effect of obesity on primary and secondary outcome measures. Results Mean BMI was 30 kg/m(2), reflecting a significantly overweight population. Each BMI group reported statistically significant improvement on all self-reported outcome measures. Contrary to our hypothesis, however, there was no association between BMI group and primary outcome measures. Patients with BMI of 35 to 39.99 visited the emergency department with complaints of pain significantly more often than the other groups. Otherwise, we did not detect any differences in the secondary outcome measures between BMI groups. Conclusions Patients of all levels of obesity experienced significant improvement following elective thoracolumbar spine surgery. These outcomes were achieved without increased risk of postoperative complications such as infection and reoperation. A risk-benefit algorithm to assist with surgical decision making for obese patients would be valuable to surgeons and patients alike.

  18. Assessing psoriasis severity and outcomes for clinical trials and routine clinical practice.

    PubMed

    Chalmers, Robert J G

    2015-01-01

    Psoriasis is a complex disease. Dermatologists have not documented psoriasis severity, except in clinical trials; doing so requires tools for assessing psoriasis and an understanding of what changes in those assessments mean in terms of outcome. Two psoriasis assessment tools have dominated: The Psoriasis Area and Severity Index and the Dermatology Life Quality Index. There are advantages and disadvantages to each. Newer instruments may not be more suitable for documenting psoriasis. There may be benefits in terms of patient ownership of disease management from using self-assessment tools for documenting severity, for example, the Self-assessment version of the Simplified Psoriasis Index.

  19. [Clinical outcomes: the impact of patient-centered care].

    PubMed

    Lin, Chia-Huei; Tzeng, Wen-Chii; Chiang, Shang-Lin; Chiang, Li-Chi

    2012-12-01

    An extensive body of literature advocating a "patient-centered" approach to medical care has emerged over the past three decades. This approach is now a mainstream trend in healthcare. Despite its popularity, there remains little consensus regarding the content or definition of patient-centered care. Various quantitative and qualitative research studies have extracted core meanings from "doctor-patient relationship" perspectives and investigated the relationships of these meanings with patient satisfaction, compliance with health promoting behavior, and health status. Mead and Bower's review of the conceptual and empirical literature represented the first attempt to develop a model of the doctor-patient relationship that considered the multiple aspects embraced by the "patient-centered" approach. However, any interpretation of the "patient-centered" concept that fails to consider the perspective of nursing is likely incomplete, as patient-centered care is the essence of nursing. This paper reviewed the concept of "patient-centered care", conducted a systematic review of randomized control trials to explore the effectiveness of patient-centered care, and integrated nursing-related studies that focused on patient-centered care. Our search covered articles published through the end of February 2011 in the Cochrane Controlled Trials Register, JBI, MEDLINE, CINAHL, Pubmed, ProQuest, PsycInfo, and CEPS, with 13 relevant articles identified. The majority of trials addressed by these studies demonstrated a positive "patient-centered care" effect on self-care knowledge and skills but a limited/insignificant effect on disease improvement. The reviewed studies used traditional definitions of "patient-centered care" that were inconsistent with the concepts defined by Mead and Bower. Heterogeneities exist between reviewed studies and the lack of related research in Taiwan. We thus integrated outcome indicators related to "patient-centered care". This study may be referenced by

  20. 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.

  1. 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

  2. Tumor Endothelial Inflammation Predicts Clinical Outcome in Diverse Human Cancers

    PubMed Central

    Filippo, Matthew; Labay, Edwardine; Beckett, Michael A.; Mauceri, Helena J.; Liang, Hua; Darga, Thomas E.; Perakis, Samantha; Khan, Sajid A.; Sutton, Harold G.; Zhang, Wei; Khodarev, Nikolai N.; Garcia, Joe G. N.; Weichselbaum, Ralph R.

    2012-01-01

    Background Vascular endothelial cells contribute to the pathogenesis of numerous human diseases by actively regulating the stromal inflammatory response; however, little is known regarding the role of endothelial inflammation in the growth of human tumors and its influence on the prognosis of human cancers. Methods Using an experimental model of tumor necrosis factor-alpha (TNF-α)-mediated inflammation, we characterized inflammatory gene expression in immunopurified tumor-associated endothelial cells. These genes formed the basis of a multivariate molecular predictor of overall survival that was trained and validated in four types of human cancer. Results We report that expression of experimentally derived tumor endothelial genes distinguished pathologic tissue specimens from normal controls in several human diseases associated with chronic inflammation. We trained these genes in human cancer datasets and defined a six-gene inflammatory signature that predicted significantly reduced overall survival in breast cancer, colon cancer, lung cancer, and glioma. This endothelial-derived signature predicted outcome independently of, but cooperatively with, standard clinical and pathological prognostic factors. Consistent with these findings, conditioned culture media from human endothelial cells stimulated by pro-inflammatory cytokines accelerated the growth of human colon and breast tumors in immunodeficient mice as compared with conditioned media from untreated endothelial cells. Conclusions This study provides the first prognostic cancer gene signature derived from an experimental model of tumor-associated endothelial inflammation. These findings support the notion that activation of inflammatory pathways in non-malignant tumor-infiltrating endothelial cells contributes to tumor growth and progression in multiple human cancers. Importantly, these results identify endothelial-derived factors that could serve as potential targets for therapy in diverse human cancers

  3. Clinical Outcome of Hypofractionated Stereotactic Radiotherapy for Abdominal Lymph Node Metastases

    SciTech Connect

    Bignardi, Mario; Navarria, Piera; Mancosu, Pietro; Cozzi, Luca; Fogliata, Antonella; Tozzi, Angelo; Castiglioni, Simona; Carnaghi, Carlo; Tronconi, Maria Chiara; Santoro, Armando; Scorsetti, Marta

    2011-11-01

    Purpose: We report the medium-term clinical outcome of hypofractionated stereotactic body radiotherapy (SBRT) in a series of patients with either a solitary metastasis or oligometastases from different tumors to abdominal lymph nodes. Methods and Materials: Between January 2006 and June 2009, 19 patients with unresectable nodal metastases in the abdominal retroperitoneal region were treated with SBRT. Of the patients, 11 had a solitary nodal metastasis and 8 had a dominant nodal lesion as part of oligometastatic disease, defined as up to five metastases. The dose prescription was 45 Gy to the clinical target volume in six fractions. The prescription had to be downscaled by 10% to 20% in 6 of 19 cases to keep within dose/volume constraints. The first 11 patients were treated with three-dimensional conformal techniques and the last 8 by volumetric intensity-modulated arc therapy. Median follow-up was 1 year. Results: Of 19 patients, 2 had a local progression at the site of SBRT; both also showed concomitant tumor growth at distant sites. The actuarial rate of freedom from local progression was 77.8% {+-} 13.9% at both 12 and 24 months. Eleven patients showed progressive local and/or distant disease at follow-up. The 12- and 24-month progression-free survival rates were 29.5% {+-} 13.4% and 19.7% {+-} 12.0%, respectively. The number of metastases (solitary vs. nonsolitary oligometastases) emerged as the only significant variable affecting progression-free survival (p < 0.0004). Both acute and chronic toxicities were minimal. Conclusions: Stereotactic body radiotherapy for metastases to abdominal lymph nodes was shown to be feasible with good clinical results in terms of medium-term local control and toxicity rates. Even if most patients eventually show progressive disease at other sites, local control achieved by SBRT may be potentially significant for preserving quality of life and delaying further chemotherapy.

  4. 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...

  5. Key symptom domains to be assessed in fibromyalgia (outcome measures in rheumatoid arthritis clinical trials).

    PubMed

    Choy, Ernest H; Mease, Philip J

    2009-05-01

    This article discusses the key symptom domains to be assessed in fibromyalgia. Development of a consensus on a core set of outcome measures that should be assessed and reported in all clinical trials is needed to facilitate interpretation, pooling, and comparison of results. This aligns with the key objective of the Outcome Measures in Rheumatoid Arthritis Clinical Trials initiative to improve outcome measurement in rheumatic diseases through a data-driven interactive consensus process.

  6. Fatal Outcome of Multiple Clinical Presentations of Human Herpesvirus 8-related Disease After Solid Organ Transplantation.

    PubMed

    Vijgen, Sandrine; Wyss, Caroline; Meylan, Pascal; Bisig, Bettina; Letovanec, Igor; Manuel, Oriol; Pascual, Manuel; de Leval, Laurence

    2016-01-01

    Kaposi sarcoma is the most common human herpesvirus 8 (HHV-8)-related disease described after solid organ transplantation. Multicentric Castleman disease and hemophagocytic syndrome are other potential HHV-8-induced entities but are less frequently reported. We describe the case of a liver transplant recipient who presented with an acute febrile illness 1 year after transplantation with a rapidly fatal outcome. Autopsy revealed 3 distinct HHV-8-related entities: Kaposi sarcoma, HHV-8-associated multicentric Castleman disease with microlymphomas and a severe hemophagocytic syndrome. Retrospective serologic tests suggested that HHV-8 was likely transmitted by the seropositive donor at the time of transplantation. To our knowledge, this is the first case of copresentation of 3 clinical presentations of HHV-8-mediated human disease in the post-transplant setting. Considering the absence of systematic screening of organ donors/recipients for HHV-8 infection, HHV-8-related illness should be suspected in transplant recipients who present with acute febrile illness, systemic symptoms, lymphadenopathies, and/or multiorgan failure to rapidly document the diagnosis and provide timely an adequate treatment.

  7. Comparison in clinical outcome of two surgical treatments in degenerative scoliosis.

    PubMed

    Sun, Yapeng; Shen, Yong; Ding, Wenyuan; Qie, Suhui; Zhang, Wei; Yang, Dalong; Wang, Linfeng

    2014-09-01

    To evaluate the clinical outcome of two different surgical treatments in treating degenerative scoliosis. Forty patients with degenerative scoliosis hospitalized in our department from June 2010 to June 2012 were selected. They were randomly divided into two groups. The first group was performed on the points with nerve or spinal compression for decompression, bone grafting, and short-segmental fixation in situ; The second group was treated with sufficient decompression, long-segmental fixation, and short-segmental fusion to operate orthopedic on scoliosis in three dimensions. All patients completed the follow-up period for more than 1 year, with the average of 18 months. Bone grafting fusion was achieved in all of the patients. The second group showed significantly better result in remission rate of postoperative pain and ODI improvement rate than the first group. Long-segmental internal fixation orthopedic is a better surgical option for patients with degenerative scoliosis to achieve sufficient decompression and three-dimensional orthopedic; therefore, it is a better solution for biomechanical reconstruction of spine.

  8. The relationship between displacement and clinical outcome after distal radius (Colles') fracture.

    PubMed

    Finsen, V; Rod, O; Rød, K; Rajabi, B; Alm-Paulsen, P S; Russwurm, H

    2013-02-01

    We reviewed 260 patients who had been treated non-operatively for a dorsally displaced distal radius fracture a mean 6.3 (range 2.5-12.7) years earlier, in an attempt to find the limits of displacement compatible with a good clinical outcome. We excluded patients with previous or later injuries to the same limb. Bivariate analysis revealed a highly statistically significant relationship between radiographic displacement at review and clinical outcome scores. Correlation coefficients varied between 0.14 and 0.30. However, multiple linear regression analysis using most factors commonly thought to be of importance in determining the clinical outcome as independent variables explained only 23% of the variability of the clinical outcome. Dorsal angulation, ulnar variance, and radial inclination together accounted for only 11% of the variability. We conclude that the final alignment of the distal radius as shown radiologically has only a minor influence on the clinical outcome of Colles' type distal radius fractures.

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

    PubMed

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

    2015-02-01

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

  10. Molecular mechanisms of carbapenem resistance in Enterobacter cloacae clinical isolates from Korea and clinical outcome.

    PubMed

    Lee, Yangsoon; Choi, Heekyeong; Yum, Jong Hwa; Kang, Girung; Bae, Il Kwon; Jeong, Seok Hoon; Lee, Kyungwon

    2012-01-01

    We investigated the molecular mechanisms of carbapenem resistance in clinical isolates of Enterobacter cloacae and their clinical characteristics. Nonreplicable E. cloacae isolates were recovered from six cancer patients and one patient with liver cirrhosis at a tertiary-care hospital in Korea between 2002 and 2009. Two patients who were considered to have a true infection caused by these microorganisms have died. All isolates produced AmpC β-lactamases, including ACT-1, ACT-2, MIR-3 and DHA-1, and CTX-M- or SHV-type extended-spectrum β-lactamase. Two isolates produced plasmid-borne VIM-2 carbapenemase. All probes specific for bla(AmpC) genes hybridized with I-CeuI chromosomal fragments were also recognized by a probe specific for 16S rDNA, suggesting a chromosomal location. Sodium dodecyl sulfate-polyacrylamide gel electrophoresis showed that a major outer membrane protein, OmpF, was absent in all isolates. PFGE of XbaI-digested DNA were considered to be unrelated. The results of our study suggest that the chromosomal AmpC β-lactamase with impermeability in E. cloacae clinical isolates implicated in reduced carbapenem susceptibility. Although carbapenem-resistant E. cloacae isolates were isolated in a few patients in our study, the clinical outcomes were grave. Therefore, the patients colonized or infected by carbapenem-resistant E. cloacae isolates should gain attention of antibiotic therapy.

  11. 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.

  12. 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

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

    PubMed

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

    2016-05-31

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

  14. Clinical Outcome of a Wide-diameter Bone-anchored Hearing Implant and a Surgical Technique With Tissue Preservation

    PubMed Central

    Mowinckel, Marius S.; Møller, Martin N.; Wielandt, Kirsten N.; Foghsgaard, Søren

    2016-01-01

    Objective: To investigate the clinical outcome of a surgical technique with tissue preservation for a wide bone-anchored hearing implant concerning postoperative complications, skin reactions, implant loss, and implant stability. Study Design: Consecutive, prospective case series. Setting: Tertiary referral center. Patients: Twenty-four adult patients with normal skin quality were enrolled. Intervention(s): Implantation of bone-anchored implant was performed using a one-stage linear-incision technique with tissue preservation surgery. Main Outcome Measures(s): Skin and soft tissue reactions according to Holgers grading system. Pain and numbness measured according to visual analogue scale. Implant stability quotient values were recorded using resonance frequency analysis. Follow-up at 10 days, 6 weeks, 6 months, and 1 year after surgery. Results: Primary implant stability was good and a significant increase in implant stability quotient occurred during the first 10 days and continued to be stable throughout the 1-year observation period. No implants were lost. Skin and soft tissue reactions were few, no reaction (Holger grade 0) was observed in 88% of the follow-up examinations and no grade 4 reactions occurred. Pain and numbness were minimal. Conclusion: The wide implant showed good stability initially and throughout the observation period. Skin and soft tissue reactions were rare and minor. No implants were lost. PMID:26954348

  15. Clinical outcomes of guided tissue regeneration with Atrisorb membrane in the treatment of intrabony defects: a 3-year follow-up study.

    PubMed

    Sakallioglu, Umur; Yavuz, Umit; Lütfioglu, Müge; Keskiner, Ilker; Açikgöz, Gökhan

    2007-02-01

    In this controlled clinical trial, initial and long-term treatment outcomes of guided tissue regeneration (GTR) were investigated for a synthetic absorbable membrane (Atrisorb) in intrabony defects. Eighteen defects in 16 patients received GTR with Atrisorb (test), with the membrane applied by an indirect method, and 15 defects in 15 patients were treated with open flap debridement (control). Probing pocket depth (PPD), gingival recession (GR), clinical attachment level (CAL), and linear alveolar bone level (ABL) were recorded at baseline and at 1 and 3 years following the treatment procedures and were assessed as the therapeutic outcome parameters. Both groups demonstrated significant PPD reduction and CAL and ABL gain after 1 year. Among these parameters, alterations in PPD and CAL were statistically significantly greater in the test group than the control group 1 year postsurgery. No significant changes were noted in the parameters of the first year between and within the study groups after 3 years. The results suggest that GTR performed with Atrisorb membrane via an indirect application method may provide favorable clinical outcomes for intrabony defects, and these outcomes may be maintained at least as well as open flap debridement over an extended period.

  16. Disability benefits and clinical outcomes among homeless veterans with psychiatric and substance abuse problems.

    PubMed

    Mares, Alvin S; Rosenheck, Robert A

    2007-02-01

    This study examined the relationship between disability payment status and clinical outcomes among 305 homeless veterans entering VA treatment. Disability status and clinical outcomes were characterized using self-report data at program entry, and quarterly for 2 years thereafter. Seeking or already receiving disability benefits at program entry was not associated with any of the 8 clinical outcomes examined. Those seeking or receiving disability benefits during the 2 years that followed showed more serious mental health problems and lower levels of mental health functioning, but no greater risk of substance use or not being employed nor worse housing outcomes than those who remained uninterested in applying for disability benefits. This study does not, therefore, support the notion that disability orientation results in poorer clinical outcomes, at least not among homeless veterans.

  17. Clinical Research and Patient-Rated Outcome Measures in Hand Surgery

    PubMed Central

    Calfee, Ryan P.; Adams, Amelia A.

    2012-01-01

    High quality clinical research incorporating standardized outcome assessments is necessary to advance the field of hand surgery. Although such research can be conducted with little direct cost, effectively answering clinical questions requires thoughtful study design. Relevant concepts to consider include sample size determination, study end-points, data management, and choice of outcome measures. Provided the emphasis on, and proliferation of, patient-rated outcome measures, the clinician-researcher should consider the unique aspects of commonly referenced outcome measures when initiating an investigation. PMID:22464236

  18. One-year clinical outcome after laser treatment for retinopathy of prematurity at a tertiary center in Turkey.

    PubMed

    Gunay, Murat; Celik, Gokhan; Ovali, Fahri; Yetik, Huseyin; Aktas, Alev; Gunay, Betul Onal

    2015-02-01

    The purpose of the study is to evaluate the clinical outcome of laser photocoagulation (LPC) in the treatment of retinopathy of prematurity (ROP) at a referral hospital in Turkey. In this retrospective study, a chart review of infants who underwent LPC for ROP between June 2011 and June 2013 was done. Clinical and demographic characteristics, laser parameters, anatomic, and refractive outcomes were evaluated. Totally 113 infants (202 eyes) were enrolled in the study. Of the 202 eyes, 29 eyes had threshold ROP, 141 eyes had prethreshold ROP, and 32 eyes had aggressive posterior ROP (APROP) at initial interventions. The mean gestational age (GA) was 28.13 ± 1.99 weeks (range between 24 and 33 weeks), the mean birth weight (BW) was 1,147.77 ± 341.77 g (range between 530 and 2,000 g) and the mean postmenstrual age (PMA) at first laser treatment time was 35.79 ± 1.74 weeks (range between 33 and 39 weeks). The mean number of laser spots (NLS) applied for each eye was 1,358.05 ± 369.91. Eyes with APROP had higher number of NLS than eyes with threshold ROP and prethreshold ROP (P < 0.01). Anatomic outcome was favorable for 171 eyes (84.7 %) at the end of the 1-year follow-up. Refractive data were available for 56 infants (100 eyes). The mean refractive error was 0.00 ± 2.48D SE. The incidence of high myopia (>5D) and strabismus was 2 and 14.3 %, respectively. Laser photocoagulation is an effective therapy for ROP. Early and appropriate laser treatment improves the clinical outcome of the disease.

  19. Clinical outcomes and neurodevelopmental outcome of prenatally diagnosed agenesis of corpus callosum in single center of Korea

    PubMed Central

    Kim, Sung Eun; Jang, Hye-In; Chang, Kylie Hae-jin; Sung, Ji-Hee; Lee, Jiwon; Lee, Jeehun; Choi, Suk-Joo; Roh, Cheong-Rae; Kim, Jong-Hwa

    2017-01-01

    Objective With recent advances and frequent use of prenatal ultrasound, the antenatal diagnosis of agenesis of the corpus callosum (ACC) is not rare in obstetrics practices. However, information regarding the long-term neurological outcome remains uncertain. The aim of this study was to investigate clinical outcomes of prenatally diagnosed ACC and to analyze postnatal neurodevelopmental outcomes of ACC neonates born in our single center. Methods We retrospectively reviewed 56 cases of prenatally suspected ACC referred to our center. Results Fifty-six fetuses were diagnosed with ACC, and 12 of those were followed-up in our center until delivery. Of the remaining 44, 7 were delivered after being referred back to the original hospital, 23 were lost to follow-up, and 14 had unknown outcomes. Among all 56, 29 were considered to have isolated ACC and 27 were considered to have non-isolated ACC. Of the 10 live fetuses delivered in our center, four had isolated ACC, three had non-isolated ACC, and the rest had outcomes unrelated to ACC. Neurodevelopmental outcome was followed-up until approximately age 3 years. Of the four with isolated ACC, three (75%) had normal neurodevelopmental outcomes. Conclusion Similar to other studies, the results of our single-center study included positive neurodevelopmental outcomes for those with isolated ACC. However, despite our endeavor to counsel patients with prenatally diagnosed ACC, the delivery rate in our center was quite low. Therefore, larger, multicenter, retrospective studies including long-term neurological development outcomes are crucial and urgently needed to provide better counseling. PMID:28217666

  20. Clinical outcomes using standard phacoemulsification and femtosecond laser-assisted surgery with toric intraocular lenses

    PubMed Central

    Espaillat, Arnaldo; Pérez, Obniel; Potvin, Richard

    2016-01-01

    Purpose To compare the 1-month and 1-year results of toric intraocular lens (IOL) implantation with standard (manual) phacoemulsification vs femtosecond laser-assisted surgery. Patients and methods Refractive data, visual acuity data, and ocular aberration measured with a wavefront aberrometer were collected for two groups of patients from one site. The first group had standard phacoemulsification, while the second group had femtosecond laser-assisted surgery, and both groups were implanted with toric IOLs, either monofocal or multifocal. Differences in visual acuity, refractive outcomes, and higher order aberrations – total, corneal, and internal – were evaluated at 1 month and 1 year postoperatively. Results Toric IOLs were implanted in 62 eyes using standard phacoemulsification and 53 eyes using femtosecond laser-assisted surgery. Uncorrected visual acuity and best-spectacle-corrected visual acuity at 1 month and 1 year were not statistically significantly different between the groups (P>0.05) nor was the mean cylinder or mean spherical equivalent refraction (P>0.12). Total ocular higher order aberrations were significantly different between the groups (P<0.05), but absolute differences appeared to be the same. Internal vertical coma was significantly lower in the femto group at 1 year (P=0.03). Differences in aberrations did not correlate with corrected or uncorrected visual acuity. Conclusion Patients who underwent uncomplicated lens surgery with toric IOLs in both the groups had comparable refractive outcomes in terms of visual acuity and residual refraction at 1 year. The femto group had significantly lower internal vertical coma at 1 year. PMID:27099462

  1. Clinical profile & predictors of poor outcome of adult HIV-tuberculosis patients in a tertiary care centre in north India

    PubMed Central

    Sharma, Surendra K.; Soneja, Manish; Prasad, K. T.; Ranjan, Sanjay

    2014-01-01

    Background & objectives: There is a paucity of data from India on response to treatment of tuberculosis (TB) in patients with human immunodeficiency virus (HIV)-TB co-infection. This study was done to assess the frequency and pattern of TB, outcome of anti-tuberculosis treatment, and the factors related to poor outcome of TB treatment in adult patients with HIV infection. Methods: Retrospective review of case records of HIV-TB co-infected patients attending the antiretroviral therapy (ART) clinic in a tertiary care centre in north India was done. Results: Of the 1754 patients included in the study, 583 (33.2%) were diagnosed with active TB and 466 (79.9%) of them had CD4 count less than 200/μl at diagnosis. Extrapulmonary TB was diagnosed in 372 (63.8%) patients [76 (20.4%) had disseminated TB], and pulmonary TB in 211 (36.2%) patients. Favourable outcome (cure and completed treatment) was observed in 332 (77%) patients. Unfavourable outcome included default (8.1%), treatment failure (1.6%), and death (13.2%). At 1-year post-treatment follow up, 12 (3.6%) patients had disease relapse. CD4 count of less than 200/μl at diagnosis [OR-2.32, CI (1.06-5.09)], and retreatment cases [OR-2.91, CI (1.22-6.89)] were independent predictors of unfavourable outcome. Interpretation & conclusions: There is an urgent need to strengthen the information, education, communication activities and expand the ART services to meet the requirement of early testing and treatment initiation in patients co-infected with HIV-TB. The findings highlight the need for performing drug susceptibility testing (DST) for patients starting retreatment regimen to improve treatment outcome. PMID:24604050

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

    ERIC Educational Resources Information Center

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

    1995-01-01

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

  3. Research setting versus clinic setting: Which produces better outcomes in cognitive therapy for depression?

    PubMed Central

    Gibbons, Carly R.; Stirman, Shannon Wiltsey; DeRubeis, Robert J.; Newman, Cory F.; Beck, Aaron T.

    2012-01-01

    Objective To compare the outcomes of cognitive therapy for depression under controlled and clinically representative conditions, while holding several therapist and clinical assessment factors constant. Method Treatment outcomes for a sample of 23 adults with a primary diagnosis of Major Depressive Disorder who received cognitive therapy in an outpatient clinic were compared with outcomes of 18 clients who were treated in the cognitive therapy condition of a large, multi-site randomized clinical trial of treatments for depression. All participants had been treated by one of two therapists who served as clinicians in both settings. Individuals in the two samples were diagnostically and demographically similar (approximately 50% Female, 83% White). A variety of client characteristics, assessed prior to treatment, as well as the outcomes of treatment, were examined. Results Significantly superior treatment outcomes were observed in the individuals treated in the research study, relative to clients in the outpatient clinic, and the difference was not accounted for by intake characteristics. Individuals treated by the therapists in the RCT experienced almost three times as much improvement in depressive symptoms as clients seen in the outpatient setting. Conclusions If replicated, the findings suggest that differences exist between treatment outcomes in research and outpatient settings and that these differences may not simply be due to therapist experience and training, or differences in patient populations. Future research should further examine the impact of fidelity monitoring, treatment expectation and motivation, and the duration and timing of treatment protocols on clinical outcomes. PMID:23710102

  4. 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.

  5. Outcomes of a Clinic-Based Pediatric Constraint-Induced Movement Therapy Program

    ERIC Educational Resources Information Center

    Reidy, Teressa Garcia; Naber, Erin; Viguers, Emily; Allison, Kristen; Brady, Kathleen; Carney, Joan; Salorio, Cynthia; Pidcock, Frank

    2012-01-01

    A single-group pre- and post-test design was used to evaluate functional outcomes of a constraint-induced movement therapy (CIMT) protocol implemented in an outpatient therapy center. The participants were 29 children with hemiplegia, ages 1.6-19.1 years old. The less-involved upper limb was placed in a cast that was worn 24 hr a day, 7 days a…

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

    PubMed

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

    2016-09-01

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

  7. Syndecan-4 as a biomarker to predict clinical outcome for glioblastoma multiforme treated with WT1 peptide vaccine

    PubMed Central

    Takashima, Satoshi; Oka, Yoshihiro; Fujiki, Fumihiro; Morimoto, Soyoko; Nakajima, Hiroko; Nakae, Yoshiki; Nakata, Jun; Nishida, Sumiyuki; Hosen, Naoki; Tatsumi, Naoya; Mizuguchi, Kenji; Hashimoto, Naoya; Oji, Yusuke; Tsuboi, Akihiro; Kumanogoh, Atsushi; Sugiyama, Haruo

    2016-01-01

    Aim: In cancer immunotherapy, biomarkers are important for identification of responsive patients. This study was aimed to find biomarkers that predict clinical outcome of WT1 peptide vaccination. Materials & methods: Candidate genes that were expressed differentially between long- and short-term survivors were identified by cDNA microarray analysis of peripheral blood mononuclear cells that were extracted from 30 glioblastoma patients (discovery set) prior to vaccination and validated by quantitative RT-PCR using discovery set and different 23 patients (validation set). Results: SDC-4 mRNA expression levels distinguished between the long- and short-term survivors: 1-year survival rates were 64.0 and 18.5% in SDC4-low and -high patients, respectively. Conclusion: SDC-4 is a novel predictive biomarker for the efficacy of WT1 peptide vaccine. PMID:28116121

  8. Atrial Fibrillation and Ventricular Arrhythmias: Sex Differences in Electrophysiology, Epidemiology, Clinical Presentation, and Clinical Outcomes.

    PubMed

    Gillis, Anne M

    2017-02-07

    Sex-specific differences in the epidemiology, pathophysiology, clinical presentation, clinical treatment, and clinical outcomes of atrial fibrillation (AF), sustained ventricular arrhythmias, and sudden cardiac death are recognized. Sex hormones cause differences in cardiac electrophysiological parameters between men and women that may affect the risk for arrhythmias. The incidence and prevalence of AF is lower in women than in men. However, because women live longer and AF prevalence increases with age, the absolute number of women with AF exceeds that of men. Women with AF are more symptomatic, present with more atypical symptoms, and report worse quality of life in comparison with men. Female sex is an independent risk factor for death or stroke attributable to AF. Oral anticoagulation therapy for stroke prevention has similar efficacy for men and women, but older women treated with warfarin have a higher residual risk of stroke in comparison with men. Women with AF are less likely to receive rhythm control antiarrhythmic drug therapy, electric cardioversion, or catheter ablation in comparison with men. The incidence and prevalence of sustained ventricular arrhythmias and sudden cardiac death are lower in women than in men. Women receiving implantable cardioverter defibrillators for primary prevention of sudden cardiac death are less likely to experience sustained ventricular arrhythmias in comparison with men. In contrast, women receiving a cardiac resynchronization therapy implantable cardioverter defibrillator for the treatment of heart failure are more likely to benefit than men. Women are less likely to be referred for implantable cardioverter defibrillator therapy despite current guideline recommendations. Women are more likely to experience a significant complication related to implantable cardioverter defibrillator implantation in comparison with men. Whether sex differences in treatment decisions reflect patient preferences or treatment biases requires

  9. Religion, Spirituality, and HIV Clinical Outcomes: A Systematic Review of the Literature.

    PubMed

    Doolittle, B R; Justice, A C; Fiellin, D A

    2016-12-21

    This systematic review evaluates the association between religion, spirituality and clinical outcomes in HIV-infected individuals. A systematic literature review was conducted for all English language articles published between 1980 and 2016 in relevant databases. Six hundred fourteen studies were evaluated. 15 met inclusion criteria. Ten (67%) studies reported a positive association between religion or spirituality and a clinical HIV outcome. Two (13%) studies failed to detect such an association; and two (13%) demonstrated a negative association. One study (7%) identified features of religiosity and spirituality that had both negative and positive associations with HIV clinical outcomes. Recognizing the religious or spiritual commitments of patients may serve as an important component of patient care. Further longitudinal studies and interventions might be required to further clarify the potential impact of religion and spirituality on HIV clinical outcomes.

  10. 77 FR 66848 - Minimum Clinically Important Difference: An Outcome Metric in Orthopaedic Device Science and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-11-07

    ... HUMAN SERVICES Food and Drug Administration Minimum Clinically Important Difference: An Outcome Metric in Orthopaedic Device Science and Regulation; Public Workshop AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public workshop. SUMMARY: The Food and Drug Administration (FDA) is...

  11. Relationship between Ambulatory BP and Clinical Outcomes in Patients with Hypertensive CKD

    PubMed Central

    Rahman, Mahboob; Hu, Bo; Appel, Lawrence J.; Charleston, Jeanne; Contreras, Gabriel; Faulkner, Marquetta L.; Hiremath, Leena; Jamerson, Kenneth A.; Lea, Janice P.; Lipkowitz, Michael S.; Pogue, Velvie A.; Rostand, Stephen G.; Smogorzewski, Miroslaw J.; Wright, Jackson T.; Greene, Tom; Gassman, Jennifer; Wang, Xuelei; Phillips, Robert A.

    2012-01-01

    Summary Background and objectives Abnormal ambulatory BP (ABP) profiles are commonplace in CKD, yet the prognostic value of ABP for renal and cardiovascular outcomes is uncertain. This study assessed the relationship of baseline ABP profiles with CKD progression and subsequent cardiovascular outcomes to determine the prognostic value of ABP beyond that of clinic BP measurements. Design, setting, participants, & measurements Between 2002 and 2003, 617 African Americans with hypertensive CKD treated to a clinic BP goal of <130/80 mmHg were enrolled in this prospective, observational study. Participants were followed for a median of 5 years. Primary renal outcome was a composite of doubling of serum creatinine, ESRD, or death. The primary cardiovascular outcome was a composite of myocardial infarction, hospitalized congestive heart failure, stroke, revascularization procedures, cardiovascular death, and ESRD. Results Multivariable Cox proportional hazard analysis showed that higher 24-hour systolic BP (SBP), daytime, night-time, and clinic SBP were each associated with subsequent renal (hazard ratio, 1.17–1.28; P<0.001) and cardiovascular outcomes (hazard ratio, 1.22–1.32; P<0.001). After controlling for clinic SBP, ABP measures were predictive of renal outcomes in participants with clinic SBP <130 mmHg (P<0.05 for interaction). ABP predicted cardiovascular outcomes with no interaction based on clinic BP control. Conclusions ABP provides additional information beyond that of multiple clinic BP measures in predicting renal and cardiovascular outcomes in African Americans with hypertensive CKD. The primary utility of ABP in these CKD patients was to identify high-risk individuals among those patients with controlled clinic BP. PMID:22935847

  12. Psychosocial and Clinical Outcomes of a Cognitive Behavioral Therapy for Asians and Pacific Islanders with Type 2 Diabetes: A Randomized Clinical Trial

    PubMed Central

    Li, Dongmei; Davis, James; Arakaki, Richard

    2015-01-01

    Asian Americans and Pacific Islanders are twice as likely to be diagnosed with type 2 diabetes compared to Caucasians. The objective was to determine the effect of cognitive behavioral therapy on quality of life, general health perceptions, depressive symptoms, and glycemia in Asians and Pacific Islanders with type 2 diabetes. The design was a randomized controlled clinical trial comparing cognitive behavioral therapy to diabetes education and support for six weekly sessions. Participants were recruited from two endocrinology practices; 207 were enrolled. The cognitive behavioral therapy group was provided self-management tools which included biofeedback, breathing exercises, and stress relievers, while the diabetes education and support group included diabetes education and group discussions. Assessments of psychosocial and clinical outcomes were obtained before and after sessions and 12 months PostSession. Differences between the two groups were examined using linear mixed-effects models with linear contrasts. The cognitive behavioral therapy group had improved depressive symptom scores from PreSession to EndSession compared to the diabetes education and support group (P < .03), but the improvement did not extend to 12 months PostSession. Similar results were observed with misguided support scores in the Multidimensional Diabetes Questionnaire (P < .03) and susceptibility in health beliefs (P < .01), but no significant differences in HbA1c improvement were found between the two groups. Both interventions improved outcomes from baseline but were not sustained for 1 year. PMID:26568899

  13. Psychosocial and Clinical Outcomes of a Cognitive Behavioral Therapy for Asians and Pacific Islanders with Type 2 Diabetes: A Randomized Clinical Trial.

    PubMed

    Inouye, Jillian; Li, Dongmei; Davis, James; Arakaki, Richard

    2015-11-01

    Asian Americans and Pacific Islanders are twice as likely to be diagnosed with type 2 diabetes compared to Caucasians. The objective was to determine the effect of cognitive behavioral therapy on quality of life, general health perceptions, depressive symptoms, and glycemia in Asians and Pacific Islanders with type 2 diabetes. The design was a randomized controlled clinical trial comparing cognitive behavioral therapy to diabetes education and support for six weekly sessions. Participants were recruited from two endocrinology practices; 207 were enrolled. The cognitive behavioral therapy group was provided self-management tools which included biofeedback, breathing exercises, and stress relievers, while the diabetes education and support group included diabetes education and group discussions. Assessments of psychosocial and clinical outcomes were obtained before and after sessions and 12 months PostSession. Differences between the two groups were examined using linear mixed-effects models with linear contrasts. The cognitive behavioral therapy group had improved depressive symptom scores from PreSession to EndSession compared to the diabetes education and support group (P < .03), but the improvement did not extend to 12 months PostSession. Similar results were observed with misguided support scores in the Multidimensional Diabetes Questionnaire (P < .03) and susceptibility in health beliefs (P < .01), but no significant differences in HbA1c improvement were found between the two groups. Both interventions improved outcomes from baseline but were not sustained for 1 year.

  14. Prediction of radiological outcome in early rheumatoid arthritis in clinical practice: role of antibodies to citrullinated peptides (anti-CCP)

    PubMed Central

    Forslind, K; Ahlmen, M; Eberhardt, K; Hafstrom, I; Svensson, B

    2004-01-01

    Objective: To investigate the role of anti-cyclic citrullinated peptide antibody (anti-CCP) for the prediction of radiological outcome in patients with early rheumatoid arthritis. Methods: Anti-CCP was assessed at baseline in 379 patients with early rheumatoid arthritis (disease duration <1 year). Radiological joint damage and progression were assessed by Larsen score after two years of follow up (end point) and used as outcome variables. The prognostic value of anti-CCP and other demographic and disease related baseline variables were assessed by univariate and multivariate analyses, including calculation of odds ratios (OR), predictive values, and multiple logistic regression models. Results: The presence of anti-CCP was associated with significantly higher Larsen score both at baseline and at end point. Univariate predictor analysis showed that anti-CCP had the highest significant OR for radiological joint damage and progression after baseline Larsen score, followed by rheumatoid factor, erythrocyte sedimentation rate (ESR), C reactive protein, age, smoking status, and sex. In stepwise multiple regression analyses, baseline Larsen score, anti-CCP, and ESR were selected as significant independent predictors of the radiological outcomes. Conclusions: There is good evidence for an association of anti-CCP with radiological joint changes in rheumatoid arthritis. Anti-CCP is an independent predictor of radiological damage and progression. Though prediction in early rheumatoid arthritis is still far from perfect, the use of anti-CCP in clinical practice should make it easier for rheumatologists to reach judicious treatment decisions. PMID:15308518

  15. The clinical achievement portfolio: an outcomes-based assessment project in nursing education.

    PubMed

    Tracy, S M; Marino, G J; Richo, K M; Daly, E M

    2000-01-01

    Dynamic healthcare market forces impel educators to search for innovative methods of academic assessment to measure learning outcomes. The clinical achievement portfolio is a creative and systematic tool for documenting continuous improvement of student clinical learning. The authors describe the use of the portfolio as a pilot project aimed at introducing reflective thinking and measuring clinical learning in undergraduate nursing education. Potential benefits of the clinical portfolio and implications for future research are proposed.

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

    PubMed Central

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

    2014-01-01

    Atrial flutter ablation is associated with a high rate of acute procedural success and symptom improvement. The relationship between ablation and other clinical outcomes has been limited to small studies primarily conducted at academic centers. We sought to determine if catheter ablation of atrial flutter is associated with reductions in healthcare utilization, atrial fibrillation, or stroke in a large, real world population. California Healthcare Cost and Utilization Project databases were used to identify patients undergoing atrial flutter ablation between 2005 and 2009. The adjusted association between atrial flutter ablation and healthcare utilization, atrial fibrillation, or stroke was investigated using Cox proportional hazards models. Among 33,004 patients with a diagnosis of atrial flutter observed for a median of 2.1 years, 2,733 (8.2%) underwent catheter ablation. Atrial flutter ablation significantly lowered the adjusted risk of inpatient hospitalization (HR 0.88, 95% CI 0.84–0.92, p<0.001), emergency department visits (HR 0.60, 95% CI 0.54–0.65, p<0.001), and overall hospital-based healthcare utilization (HR 0.94, 95% CI 0.90–0.98, p = 0.001). Atrial flutter ablation was also associated with a statistically significant 11% reduction in the adjusted hazard of atrial fibrillation (HR 0.89, 95% CI 0.81–0.97, p = 0.01). Risk of acute stroke was not significantly reduced after ablation (HR 1.09, 95% CI 0.81–1.45, p = 0.57). In a large, real world population, atrial flutter ablation was associated with significant reductions in hospital-based healthcare utilization and a reduced risk of atrial fibrillation. These findings support the early use of catheter ablation for the treatment of atrial flutter. PMID:24983868

  17. OrderRex: clinical order decision support and outcome predictions by data-mining electronic medical records

    PubMed Central

    Chen, Jonathan H; Podchiyska, Tanya

    2016-01-01

    Objective: To answer a “grand challenge” in clinical decision support, the authors produced a recommender system that automatically data-mines inpatient decision support from electronic medical records (EMR), analogous to Netflix or Amazon.com’s product recommender. Materials and Methods: EMR data were extracted from 1 year of hospitalizations (>18K patients with >5.4M structured items including clinical orders, lab results, and diagnosis codes). Association statistics were counted for the ∼1.5K most common items to drive an order recommender. The authors assessed the recommender’s ability to predict hospital admission orders and outcomes based on initial encounter data from separate validation patients. Results: Compared to a reference benchmark of using the overall most common orders, the recommender using temporal relationships improves precision at 10 recommendations from 33% to 38% (P < 10−10) for hospital admission orders. Relative risk-based association methods improve inverse frequency weighted recall from 4% to 16% (P < 10−16). The framework yields a prediction receiver operating characteristic area under curve (c-statistic) of 0.84 for 30 day mortality, 0.84 for 1 week need for ICU life support, 0.80 for 1 week hospital discharge, and 0.68 for 30-day readmission. Discussion: Recommender results quantitatively improve on reference benchmarks and qualitatively appear clinically reasonable. The method assumes that aggregate decision making converges appropriately, but ongoing evaluation is necessary to discern common behaviors from “correct” ones. Conclusions: Collaborative filtering recommender algorithms generate clinical decision support that is predictive of real practice patterns and clinical outcomes. Incorporating temporal relationships improves accuracy. Different evaluation metrics satisfy different goals (predicting likely events vs. “interesting” suggestions). PMID:26198303

  18. Clinical Outcome of Double Kissing Crush Versus Provisional Stenting of Coronary Artery Bifurcation Lesions

    PubMed Central

    Santoso, Teguh; Zhang, Jun-Jie; Ye, Fei; Xu, Ya-Wei; Fu, Qiang; Kan, Jing; Zhang, Feng-Fu; Zhou, Yong; Xie, Du-Jiang; Kwan, Tak W.

    2017-01-01

    Background— Provisional stenting is effective for anatomic simple bifurcation lesions. Double kissing crush stenting reduces the 1-year rate of target lesion revascularization. This study aimed to investigate the 5-year clinical results of the DKCRUSH-II study (Randomized Study on Double Kissing Crush Technique Versus Provisional Stenting Technique for Coronary Artery Bifurcation Lesions). Methods and Results— A total of 370 patients with coronary bifurcation lesions who were randomly assigned to either the double kissing crush or provisional stenting group in the DKCRUSH-II study were followed for 5 years. The primary end point was the occurrence of a major adverse cardiac event at 5 years. Patients were classified by simple and complex bifurcation lesions according to the DEFINITION criteria (Definitions and Impact of Complex Bifurcation Lesions on Clinical Outcomes After Percutaneous Coronary Intervention Using Drug-Eluting Stents). At 5 years, the major adverse cardiac event rate (23.8%) in the provisional stenting group was insignificantly different to that of the double kissing group (15.7%; P=0.051). However, the difference in the target lesion revascularization rate between 2 groups was sustained through the 5-year follow-up (16.2% versus 8.6%; P=0.027). The definite and probable stent thrombosis rate was 2.7% in each group (P=1.0). Complex bifurcation was associated with a higher rate of target lesion revascularization (21.6%) at 5 years compared with 11.1% in patients with a simple bifurcation (P=0.037), with an extremely high rate in the provisional stenting group (36.8% versus 12.5%, P=0.005) mainly because of final kissing balloon inflation (19.4% versus 5.2%; P=0.036). Conclusions— The double kissing crush stenting technique for coronary bifurcation lesions is associated with a lower rate of target lesion revascularization. The optimal stenting approach based on the lesions’ complexity may improve the revascularization for patients with

  19. Comparison of real-world clinical outcomes between Cypher- and Taxus-eluting stents: the GARA-GARA study.

    PubMed

    Fukumoto, Atsushi; Otsuji, Satoru; Takiuchi, Shin; Ikushima, Masashi; Asano, Katsuaki; Terasoma, Kunihiko; Hasegawa, Katsuyuki; Yabuki, Masanori; Higashino, Yorihiko

    2011-09-01

    To evaluate real-world outcomes of PCI in unselected individuals using sirolimus-eluting (SESs) or paclitaxel-eluting stents (PESs) in a single-center randomized trial. Eight hundred consecutive patients (919 lesions) with coronary artery disease were randomized to receive SES or PES implantation. In-hospital, mid-term, and 1-year clinical and angiographical outcomes in both groups were compared. MACEs were defined as cardiac death, myocardial infarction, CABG and target vessel revascularization (TLR). Follow-up angiography was performed in 80.7% of patients. The baseline clinical characteristics were similar in both groups. Pre- and postprocedural reference vessel diameter, minimum length diameter, and diameter stenosis (%DS) were similar in both groups, as was incidence of in-hospital and mid-term MACEs. SESs significantly reduced the risk of TLR, compared with PESs (SES = 5.5%, PES = 10.5%). The superiority of SESs for TLR was also demonstrated with regard to small vessel lesions (stent diameter <2.5 mm) (SES = 6.0%, PES = 15.9%), whereas larger vessel (stent diameter >2.5 mm) lesions did not differ between groups (SES = 5.3%, PES = 8.4%). The safety and efficacy of both DESs were nearly equivalent. SESs, however, were superior to PESs in reducing mid-term TLR, particularly in the small vessel lesion subsets.

  20. Clinical Outcomes in Patients with Deferred Coronary Lesions according to Disease Severity Assessed by Fractional Flow Reserve.

    PubMed

    Won, Ki Bum; Nam, Chang Wook; Cho, Yun Kyeong; Yoon, Hyuck Jun; Park, Hyoung Seob; Kim, Hyungseop; Han, Seongwook; Hur, Seung Ho; Kim, Yoon Nyun; Park, Sang Hyun; Han, Jung Kyu; Koo, Bon Kwon; Kim, Hyo Soo; Doh, Joon Hyung; Lee, Sung Yun; Yang, Hyoung Mo; Lim, Hong Seok; Yoon, Myeong Ho; Tahk, Seung Jea; Kim, Kwon Bae

    2016-12-01

    Data on the clinical outcomes in deferred coronary lesions according to functional severity have been limited. This study evaluated the clinical outcomes of deferred lesions according to fractional flow reserve (FFR) grade using Korean FFR registry data. Among 1,294 patients and 1,628 lesions in Korean FFR registry, 665 patients with 781 deferred lesions were included in this study. All participants were consecutively categorized into 4 groups according to FFR; group 1: ≥ 0.96 (n = 56), group 2: 0.86-0.95 (n = 330), group 3: 0.81-0.85 (n = 170), and group 4: ≤ 0.80 (n = 99). Primary endpoint was major adverse cardiac events (MACE), a composite of all-cause death, myocardial infarction, and target vessel revascularization. The median follow-up period was 2.1 years. During follow-up, the incidence of MACE in groups 1-4 was 1.8%, 7.6%, 8.8%, and 13.1%, respectively. Compared to group 1, the cumulative rate by Kaplan-Meier analysis of MACE was not different for groups 2 and 3. However, group 4 had higher cumulative rate of MACE compared to group 1 (log-rank P = 0.013). In the multivariate Cox hazard models, only FFR (hazard ratio [HR], 0.95; P = 0.005) was independently associated with MACE among all participants. In contrast, previous history of percutaneous coronary intervention (HR, 2.37; P = 0.023) and diagnosis of acute coronary syndrome (ACS) (HR, 2.35; P = 0.015), but not FFR, were independent predictors for MACE in subjects with non-ischemic (FFR ≥ 0.81) deferred coronary lesions. Compared to subjects with ischemic deferred lesions, clinical outcomes in subjects with non-ischemic deferred lesions according to functional severity are favorable. However, longer-term follow-up may be necessary.

  1. Clinical outcomes following stent implantation in internal mammary artery grafts.

    PubMed

    Sharma, Arvind K; McGlynn, Scott; Apple, Sue; Pinnow, Ellen; Canos, Daniel A; Gevorkian, Natalie; Tebeica, Mihaela; Gruberg, Luis; Pichard, Augusto D; Lindsay, Joseph

    2003-08-01

    We evaluated our experience with percutaneous coronary intervention (PCI) of internal mammary artery (IMA) grafts. From the institution's database we identified 288 patients with 311 IMA lesions. Of these, 82 (26.4%) had stents placed during PCI. Angiographic success was 92%. Mortality at 1 month was 1.7%, myocardial infarction (MI) 15.7%, and target lesion revascularization (TLR) 0.4%. Cumulative 1-year event rates were mortality 6.4%, MI 20.4%, and TLR 8.0%. TLR rates were significantly higher in the stented lesions than lesions treated with angioplasty alone (19.2% vs. 4.9%; P = 0.004). The higher TLR rate in stented lesions was most apparent at the anastomotic site (25.0% vs. 4.2%; P = 0.006). Percutaneous revascularization of IMA grafts can be performed safely with high procedural success and excellent short- and long-term results. Stenting, particularly at the anastomotic site, was associated with significantly greater rates of TLR than angioplasty alone.

  2. One-year clinical outcomes in invasive treatment strategies for acute ST-elevation myocardial infarction complicated by cardiogenic shock in elderly patients

    PubMed Central

    Yoo, Yeon Pyo; Kang, Ki-Woon; Yoon, Hyeon Soo; Myung, Jin Cheol; Choi, Yu Jeong; Kim, Won Ho; Park, Sang Hyun; Jung, Kyung Tae; Jeong, Myung Ho

    2013-01-01

    Objective To investigate the clinical outcomes of an invasive strategy for elderly (aged ≥ 75 years) patients with acute ST-segment elevation myocardial infarction (STEMI) complicated by cardiogenic shock (CS). Methods Data on 366 of 409 elderly CS patients from a total of 6,132 acute STEMI cases enrolled in the Korea Acute Myocardial Infarction Registry between January 2008 and June 2011, were collected and analyzed. In-hospital deaths and the 1-month and 1-year survival rates free from major adverse cardiac events (MACE; defined as all cause death, myocardial infarction, and target vessel revascularization) were reported for the patients who had undergone invasive (n = 310) and conservative (n = 56) treatment strategies. Results The baseline clinical characteristics were not significantly different between the two groups. There were fewer in-hospital deaths in the invasive treatment strategy group (23.5% vs. 46.4%, P < 0.001). In addition, the 1-year MACE-free survival rate after invasive treatment was significantly lower compared with the conservative treatment (51% vs. 66%, P = 0.001). Conclusions In elderly patients with acute STEMI complicated by CS, the outcomes of invasive strategy are similar to those in younger patients at the 1-year follow-up. PMID:24133510

  3. [Sociodemographic, clinical and outcome differences among anxiety disorders].

    PubMed

    Bernaldo-de-Quirós, Mónica; Estupiñá, Francisco J; Labrador, Francisco J; Fernández-Arias, Ignacio; Gómez, Laura; Blanco, Carmen; Alonso, Pablo

    2012-01-01

    The aims of this paper are to analyze differences in sociodemographic and clinical characteristics among the various anxiety disorders treated in a Psychology Clinic, and the results of treatment in each anxiety disorder. Data from 282 patients of University Psychology Clinic at the Complutense University of Madrid, who had at least one diagnosis of anxiety according to DMS-IV-TR criteria, were analyzed. The most frequent anxiety disorders were nonspecific anxiety disorder (19.1%) and social phobia (18.8%). Significant differences were observed according to sex (in all disorders, the percentage of women was significantly higher than that of men, except for obsessive-compulsive disorder). Unspecific anxiety disorder required a smaller number of assessment and treatment sessions, whereas obsessive-compulsive disorder required a greater number of sessions. There were no significant differences between the percentage of patients who completed treatment and dropout rates in specific phobia, general anxiety disorder and obsessive-compulsive disorder. Differences between epidemiological and clinical data are discussed.

  4. Clinical profile and outcome of children with opsoclonus-myoclonus syndrome.

    PubMed

    Singhi, Pratibha; Sahu, Jitendra Kumar; Sarkar, Jhuma; Bansal, Deepak

    2014-01-01

    The opsoclonus-myoclonus syndrome is a distinct disorder characterized by opsoclonus, myoclonus, and ataxia, along with marked irritability and behavioral changes. Worldwide, data on its epidemiology, clinical features, and outcome are scarce. The aim of the study was to determine the clinical profile and outcome of children with this disorder. A retrospective study of all children admitted with a diagnosis of opsoclonus-myoclonus from 2000 to 2012 was done. Outcome was assessed on follow-up by direct assessment and by telephonic interview. Eleven patients with a diagnosis of opsoclonus-myoclonus were admitted over a 12-year period. Of the 11, 4 had paraneoplastic etiology. Children with paraneoplastic opsoclonus had more relapses and a poor outcome as compared to an idiopathic group. Paraneoplastic opsoclonus had a poor outcome in our experience.

  5. 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

  6. 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

  7. Improved clinical outcomes for multiple myeloma patients treated at a single specialty clinic.

    PubMed

    Berenson, Ariana; Vardanyan, Suzie; David, Michael; Wang, James; Harutyunyan, Nika Manik; Gottlieb, Jillian; Halleluyan, Ran; Spektor, Tanya M; Udd, Kyle A; Eshaghian, Shahrooz; Nassir, Youram; Eades, Benjamin; Swift, Regina; Berenson, James R

    2017-03-01

    Despite recent advances made in its treatment, multiple myeloma (MM) remains an incurable B cell malignancy. Thus, the objective for treating these patients is to prolong overall survival (OS) and preserve patients' quality of life. We have analyzed data from 264 consecutive MM patients who had their initial visit between July 1, 2004 and December 1, 2014 and have received treatment in a single clinic specializing in MM. We determined their progression-free survival (PFS, OS, and 5-year OS). The PFS for frontline (n = 165 treatments), salvage (n = 980), and all treatments (n = 1145) were 13.9, 4.6, and 5.5 months, respectively. The median OS of all patients was 98 months with a 5-year survival of 74%. The results of this study show a marked improvement in OS for unselected MM patients compared with historical data. There were no significant differences in OS between patients with different International Staging System (ISS) stages. Younger patients (<65 years old) showed a longer OS. The results of this study should help physicians predict outcomes for MM patients and be encouraging for patients with this B cell malignancy.

  8. Clinical outcome of transthoracic esophagectomy with thoracic duct resection

    PubMed Central

    Matsuda, Satoru; Takeuchi, Hiroya; Kawakubo, Hirofumi; Shimada, Ayako; Fukuda, Kazumasa; Nakamura, Rieko; Takahashi, Tsunehiro; Wada, Norihito; Kameyama, Kaori; Kitagawa, Yuko

    2016-01-01

    Abstract The number of dissected lymph nodes (LNs), surgical outcomes, and postoperative recurrence-free survival (RFS) were compared between thoracic duct (TD)-preserved and TD-resected groups. The distribution of metastasis in LNs around TD (TDLN) was reviewed. Transthoracic esophagectomy (TTE) with TD resection for esophageal cancer patients has been one of the standard procedures. Because the adipose tissue surrounding the TD contains LNs, TD resection might be necessary for radical LN dissection. However, few studies have investigated the oncological outcome of TTE with TD resection. Two hundred fifty-six consecutive patients who underwent TTE between 2004 and 2015 were retrospectively reviewed and classified into TD-preserved or TD-resected groups. The number of dissected LNs for each LN station and surgical outcomes were compared. RFS was analyzed in 155 patients who underwent TTE before December 2012. Since 2013, the TDLN number was prospectively examined, independent of the regional LNs (n = 72). Of these, the TDLN number for each location (TDLN-Ut/Mt/Lt) was investigated and the correlation between TDLN metastasis and clinicopathological factors was analyzed. The TD was preserved in 89 patients and resected in 167 patients. Patients with TD resection showed significant advanced stage. There was no significant difference in the incidence of postoperative complications, including pneumonia, anastomotic leakage, and chylothorax. The number of dissected mediastinal LNs was significantly increased in the TD-resected group. The 5-year RFS rate of cStage I patients was 67.3% in the TD-preserved group against 90.3% in the TD-resected group, showing a tendency towards RFS extension that did not quite reach statistical significance (P = 0.055). The mean TDLN-Ut/Mt/Lt numbers were 0.89/0.56/0.44, respectively. Eight of 72 (11%) patients displayed TDLN metastasis. Metastatic TDLNs were observed on the same or cranial level of the primary lesion in 7 of 8 patients

  9. Core outcome domains for controlled trials and clinical recordkeeping in eczema: international multiperspective Delphi consensus process.

    PubMed

    Schmitt, Jochen; Langan, Sinéad; Stamm, Tanja; Williams, Hywel C

    2011-03-01

    There is wide variation in the use of outcome measures for eczema. We performed a three-stage web-based international Delphi exercise to develop consensus-based sets of core outcome domains for eczema for "controlled trials" and "clinical recordkeeping". A total of 57 individuals from four stakeholder groups (consumers, clinical experts, regulatory agency representatives, and journal editors) representing 13 countries were asked to rate the importance of 19 outcome domains for eczema and to choose which domains should be included in two core sets of outcomes. Forty-six individuals (81%) participated. Participants received standardized feedback, including the group median, interquartile range, and previous responses, and the assessment was repeated in two subsequent rounds. We defined consensus a priori if at least 60% of the members of at least three stakeholder groups, including consumers, recommended domain inclusion in the core set. Consensus was achieved for inclusion of symptoms, physician-assessed clinical signs, and a measurement for long-term control of flares in the core set of outcome domains for eczema trials. We recommend including these three core outcomes in future eczema trials in order to enhance clinical interpretability and to enable meta-analyses across different studies. For recordkeeping, consensus was reached to regularly monitor eczema symptoms in clinical practice. Future work is needed to select which existing or new scales should be used to measure the domains identified as relevant for the core set.

  10. Clinician-Reported Outcome Assessments of Treatment Benefit: Report of the ISPOR Clinical Outcome Assessment Emerging Good Practices Task Force

    PubMed Central

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

    2017-01-01

    A clinician-reported outcome (ClinRO) assessment is a type of clinical outcome assessment (COA). ClinRO assessments, like all COAs (patient-reported, observer-reported, or performance outcome assessments), are used to 1) measure patients’ health status and 2) define end points that can be interpreted as treatment benefits of medical interventions on how patients feel, function, or survive in clinical trials. Like other COAs, ClinRO assessments can be influenced by human choices, judgment, or motivation. A ClinRO assessment is conducted and reported by a trained health care professional and requires specialized professional training to evaluate the patient’s health status. This is the second of two reports by the ISPOR Clinical Outcomes Assessment—Emerging Good Practices for Outcomes Research Task Force. The first report provided an overview of COAs including definitions important for an understanding of COA measurement practices. This report focuses specifically on issues related to ClinRO assessments. In this report, we define three types of ClinRO assessments (readings, ratings, and clinician global assessments) and describe emerging good measurement practices in their development and evaluation. The good measurement practices include 1) defining the context of use; 2) identifying the concept of interest measured; 3) defining the intended treatment benefit on how patients feel, function, or survive reflected by the ClinRO assessment and evaluating the relationship between that intended treatment benefit and the concept of interest; 4) documenting content validity; 5) evaluating other measurement properties once content validity is established (including intra- and inter-rater reliability); 6) defining study objectives and end point(s) objectives, and defining study end points and placing study end points within the hierarchy of end points; 7) establishing interpretability in trial results; and 8) evaluating operational considerations for the implementation

  11. 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.

  12. Clinical outcome of pancreas transplantation from marginal donors in Japan.

    PubMed

    Tomimaru, Y; Ito, T; Kawamoto, K; Hama, N; Wada, H; Kobayashi, S; Eguchi, H; Tanemura, M; Mori, M; Doki, Y; Nagano, H

    2014-04-01

    In Japan, absolute shortage of donors still continues even after the law allowing organ transplantation from deceased donors came into force in 1997. With the passage of the waiting period after registration for pancreas transplantation (PTx), both deaths and serious cases of diabetic complications necessitating withdrawal of the registration have undoubtedly increased. Therefore, so-called "marginal donor" (MD) has been considered as a potential solution for shortage of donors in Japan. The aim of the present study is to evaluate feasibility of MD in terms of post-PTx outcomes using data from Japan Organ Transplantation Network. A total of 148 PTx were performed from deceased donors in Japan from 2000 to 2012. MD was defined as follows: (1) >45 years old; (2) hemodynamically unstable at harvest using a high-dose dopamine or more than 2 vasopressors; or (3) non-heart-beating status. Postoperative outcomes after PTx were compared between the MD group and the non-MD group. Among the 148 PTx donors, 108 donors (73.0%) satisfied the criteria of MD. Early graft loss of pancreas graft during 3 months post-transplant was observed in 15 patients (10.1%), and the marginality (MD vs non-MD) was not significantly correlated with the early loss of pancreas graft. The overall patient survival of the MD group (1, 3, 5 years: 94.7%, 94.7%, 94.7%) was not significantly different from that of the non-MD group (1, 3, 5 years: 95.0%, 95.0%, 95.0%). Pancreas graft survival in the MD group (1, 3, 5 years: 80.9%, 73.2%, 66.0%) seemed to be slightly lower than that in the non-MD group (1, 3, 5 years: 92.5%, 85.2%, 77.4%), but no statistically significant differences were found between the 2 groups. These results suggest the feasibility of the use of MD for PTx.

  13. [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.

  14. Early-Onset Psychoses: Comparison of Clinical Features and Adult Outcome in 3 Diagnostic Groups

    ERIC Educational Resources Information Center

    Ledda, Maria Giuseppina; Fratta, Anna Lisa; Pintor, Manuela; Zuddas, Alessandro; Cianchetti, Carlo

    2009-01-01

    A comparison of clinical features and adult outcome in adolescents with three types of psychotic disorders: schizophrenic (SPh), schizoaffective (SA) and bipolar with psychotic features (BPP). Subjects (n = 41) were finally diagnosed (DSM-IV criteria) with SPh (n = 17), SA (n = 11) or BPP (n = 13). Clinical evaluation took place at onset and at a…

  15. 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…

  16. Applying Senge's concepts of organizational learning to clinical outcomes research and practice.

    PubMed

    Wallace, C J

    1998-09-01

    The purpose of this article is to use Senge's concepts of organizational learning as a framework for discussing issues and challenges in clinical outcomes research. Clinical outcomes research is about learning how to improve clinical practice. A learning organization balances attention to the structure and the culture in order to produce effective results. Future health care leaders will need to understand and attend to the importance of the organization's structure, but their greatest contribution will be in attending to the organizational culture to produce enduring organizational change.

  17. 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.

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

    PubMed

    Hussain, Samia; Knight, Simon R

    2016-11-01

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

  19. Clinical Experiences Are Not Predictive of Outcomes on the NATABOC Examination

    PubMed Central

    Turocy, Paula Sammarone; Comfort, Ronald E.; Perrin, David H.; Gieck, Joe H.

    2000-01-01

    Objective: To determine the efficacy of the National Athletic Trainers' Association Board of Certification (NATABOC) clinical experience requirements and individual student characteristics to predict candidate outcomes on the NATABOC certification examination. Design and Setting: For all subjects, we gathered survey information and examination scores. The survey information included age, sex, route to certification, previous athletic training and allied health experience, and clinical education experiences. Subjects: A total of 269 subjects, 22.25% of all first-time candidates for the June and November 1993 NATABOC examinations, were included in this study. Measurements: Data were analyzed for standard descriptive statistics and parametric linear regression and correlational relationships. Results: Total clinical hours, high-risk sport experiences, and previous athletic training experience were not predictive of examination outcomes. Although our results indicated a relationship between previous allied health experience and both outcome on the written section of the examination and age and outcome on the oral/practical section, these characteristics also were not predictive of examination outcomes. Conclusions: Gaining clinical experience hours in excess of 400 hours beyond the 800-or 1500-hour requirement may yield no greater benefit for an entry-level professional than less time. The quality, rather than the quantity, of clinical experiences should be evaluated. More emphasis should be placed on the achievement of an entry level of clinical competency, rather than on total hour collection. Also, because high-risk sport experiences did not predict outcomes on the NATABOC examination, the emphasis of clinical education should be on students' receiving a more structured clinical experience, in which they are progressively required to assume greater responsibilities integrating both cognitive and psychomotor skills, while working under the supervision of a certified

  20. Outcomes of genetics services: creating an inclusive definition and outcomes menu for public health and clinical genetics services.

    PubMed

    Silvey, Kerry; Stock, Jacquie; Hasegawa, Lianne E; Au, Sylvia Mann

    2009-08-15

    Third party payers, funding agencies, and lawmakers often require clinicians and public health agencies to justify programs and services by documenting results. This article describes two assessment tools--"Defining Genetics Services Framework" and "Genetics Services Outcomes Menu," created to assist public health professionals, clinicians, family advocates, and researchers to plan, evaluate, and demonstrate the effectiveness of genetics services. The tools were developed by a work group of the Western States Genetics Services Collaborative (WSGSC) consisting of public health genetics and newborn screening professionals, family representatives, a medical geneticist, and genetic counselors from Alaska, California, Hawaii, Idaho, Oregon, and Washington. The work group created both tools by an iterative process of combining their ideas with findings from a literature and World Wide Web review. The Defining Genetics Services Framework reflects the diversity of work group members. Three over-lapping areas of genetics services from public health core functions to population screening to clinical genetics services are depicted. The Genetics Services Outcomes Menu lists sample long-term outcomes of genetics services. Menu outcomes are classified under impact areas of Knowledge and Information; Financing; Screening and Identification; Diagnosis, Treatment, and Management; and Population Health. The WSGSC incorporated aspects of both tools into their Regional Genetics Plan.

  1. Clinical outcome and circulatory effects of fetal cardiac arrhythmia.

    PubMed

    Lingman, G; Lundström, N R; Marsál, K

    1986-01-01

    By means of abdominal fetal ECG and non-invasive ultrasound blood flow studies 113 cases of fetal cardiac arrhythmia were classified according to the origin of arrhythmia. Pregnancy outcome was characterized by an increased frequency of fetal distress and heart malformation, and increased fetal and neonatal mortality. The following types of arrhythmia were identified: supraventricular extrasystoles (n = 84), paroxysmal tachycardia (n = 6), sinus bradycardia (n = 3), atrial flutter (n = 1), ventricular extrasystoles (n = 14), and atrioventricular block (n = 5). In 37 cases the combined Doppler and real-time ultrasound technique was used to measure fetal aortic blood flow as a means of studying the circulatory effects of the arrhythmia. Increased peak velocity, rising slope and acceleration were found in the first post-pausal beat after a supraventricular extrasystole or a missed beat; this supports the validity of Frank-Starling law for the fetal heart and suggests that a strong relationship exists between these variables and myocardial contractility. In two cases of intra-uterine heart failure, the effect of digoxin treatment in utero on the fetal aortic flow variables was studied, results indicating a positive inotropic effect of the drug on the fetal myocardium. The estimation of fetal aortic volume blood flow in cases of fetal cardiac arrhythmia is useful for early detection of fetal cardiac failure, and for monitoring the effects of intra-uterine treatment.

  2. Large and round tumor nuclei in osteosarcoma: good clinical outcome

    PubMed Central

    de Andrea, Carlos E; Petrilli, Antonio Sergio; Jesus-Garcia, Reynaldo; Bleggi-Torres, Luiz F; Alves, Maria Teresa S

    2011-01-01

    Osteosarcoma is the most frequent primary malignant bone tumor. Distinct histological features are distinguishable based on the morphology of the tumor. Differences in nuclei size and shape are often observed in osteosarcoma reflecting its broad histopathological heterogeneity. This study explores the relevance of two nuclear parameters in osteosarcoma: large area and round shape. Computerized nuclear morphometry was performed in 56 conventional osteosarcoma preoperative biopsies. The mean patient follow-up time was 35.1 months. Based on the nuclear area, no significant difference (P = 0.09) in overall survival between patients with large (> 42.5 μm2) and small (< 42.5 μm2) tumor nuclei was found. However, when cases with large and round nuclei were analyzed jointly (> 42.5 μm2 and coefficient of nuclear roundness > 0.7), these two parameters together were likely to be a predictive factor (P = 0.05). Osteosarcoma patients with large and round tumor nuclei had a better outcome than patients with small and polymorphic (ovoid or spindle-shaped) nuclei. In this study, nuclear morphometry proved to be a useful tool to shed light on the biology of osteosarcoma showing that some morphometric parameters can be easily applied to help identifying patients with a good prognosis. PMID:21326812

  3. Clinical outcome after percutaneous flexor tenotomy in forefoot surgery.

    PubMed

    Debarge, Romain; Philippot, Rémy; Viola, Jérémy; Besse, Jean Luc

    2009-10-01

    The aim of this study was to evaluate the outcome of the percutaneous flexor tenotomy. We compared the results of two groups. The first group included 23 patients who underwent forefoot surgery without percutaneous flexor tenotomy, and the second group included 50 patients who underwent the same procedure combined with percutaneous flexor tenotomy for claw toe deformities, secondary to shortening metatarsal Scarf osteotomy. The average follow-up was 11.6 months. Three algoneurodystrophies were noted. No delayed wound healing was observed. Functional dissatisfaction rate (18% vs.17.4%) and toe pulp contact defect (12% vs. 8.7%) were not significantly different in the two groups. Toe grasping defect rate (10% vs. 4.3%) was superior in the tenotomy group. Five recurring claw toe deformities of the second toe were noted in the tenotomy group. Percutaneous flexor tenotomy is a simple, rapid, and efficient method to correct reducible secondary claw toe deformities. However, despite a significant postoperative loss of toe grasping function, no patient reported major dissatisfaction.

  4. Improving Clinical Outcomes for Patients With Class III Heart Failure.

    PubMed

    Shapiro, Melissa; Bires, Angela Macci; Waterstram-Rich, Kristen; Cline, Thomas W

    Heart failure (HF) is a serious medical problem in the United States and is placing a financial strain on the health care system. It is the leading cause of mortality and as the overall incidence continues to increase, so does the economic impact on the health care system. Innovative treatment options, in the form of disease management programs and implantable cardiac devices, such as the CorVue capable implantable cardioverter defibrillator (ICD) pacemaker, offer the promise of an enhanced quality of life and reduced mortality. Even with these advances, HF continues to be a challenge. Studies reviewing HF management programs have shown promising results. However, more studies are needed to determine which combination of HF management interventions has the greatest financial impact and yields the best patient outcomes. The objective of the research study was to compare 30-day readmission rates of patients implanted with the CorVue capable ICD pacemaker with patients with congestive heart failure (CHF) with no implanted device. The aim of the research focused on the usefulness of intrathoracic impedance monitoring alerts in guiding empirical treatment of patients with CHF to prevent HF readmissions. Methodology included a retrospective medical chart review, comparing 30-day readmission events among patients with class III CHF who received home health intervention with similar patients implanted with the CorVue ICD.

  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.

  6. Clinical outcomes of excision arthroplasty for Kienbock's disease.

    PubMed

    Matsuhashi, Tomoya; Iwasaki, Norimasa; Kato, Hiroyuki; Minami, Michio; Minami, Akio

    2011-01-01

    We have carried out a replacement of the lunate in 12 patients with advanced Kienböck's disease, with excision of the lunate and insertion of an iliac bone flap wrapped into palmaris longus. The aims of this study were to determine the effect of this procedure for advanced Kienböck's disease. At a mean follow-up period of 45.3 months, the mean clinical score was excellent in all cases. Radiographically, progression of osteoarthritis (OA) in the radiocarpal joint was found in two patients. At follow-up, the X-ray findings indicated a reduced of osseous core in four patients. On the other hand, carpal height ratio showed no significant change at follow-up. Excision arthroplasty using a tendon ball with osseous core for advanced Kienböck's disease leads to OA progression in some cases. However, clinical results were excellent in all cases. Therefore, this current study provides effective therapeutic procedure for advanced Kienböck's disease.

  7. Combinations in multimodality treatments and clinical outcomes during cancer

    PubMed Central

    Zhang, Xiao-Ying; Zhang, Pei-Ying

    2016-01-01

    Combination approach could be easily considered as the future of therapeutics in all pathological states including cancer. Scientists are trying different combinations in order to determine synergism among different therapeutics which ultimately helps in the improved and more efficient management of the affected patients. Combination of multi-chemotherapeutic agents, or multi-drug therapy, may be the most commonly used strategy for cancer treatment. Monotherapy causes drug resistance and loses its response in patients after several cycles of treatment. While combining different anticancer drugs together for cancer treatment, as in the case of the cocktail therapy for HIV, not only overcomes the drug resistance but also leads to a synergistic effect, therefore showing prolonged survival for patients. The present review article is focused on different combinations in use for better efficiency of therapeutics against cancer. We searched the electronic database PubMed for pre-clinical as well as clinical controlled trials reporting diagnostic as well as therapeutic advances of various combinations in cancer. It was observed clearly that combination approach is better in various aspects including increase in efficacy, specificity and decline in the unwanted side effects. PMID:28101195

  8. [Bell's palsy (etiology, pathogenesis, clinical picture, course, outcome)].

    PubMed

    Al'perovich, P M; Korneichuk, A G; Konstantinovich, T I; Starinets, G A; Pshuk, Ia I

    1978-01-01

    The authors studied 908 patients with Bell's paralysis. In 373 cases the etiology was cooling, in 52--vascular diseases, in 207 cases the etiology was not established. An analysis of the clinical picture development permits to assume that different modern theories of the pathogenesis of Bell's paralysis (the theory of primary ischemia, secondary ischemia a combination of primary and secondary ischemia) do not exclude each other, finding a different application depending upon the etiology of the paralysis. The report contains a detailed description of the clinical picture and development of Bell's paralysis. It is established, that the facial nerve in Bell's paralysis is usually affected in the inferior part of the Fallopian tube. A follow-up study of 536 patients demonstrated that in 174 cases (32.4%) (those who were discharged from the hospital with an incomplete therapeutical effect) a contracture of the mimical muscles was formed. In 70 of them the symptom of "crocodile tears" was found. In 73 patients there were homolateral relapses of Bell's paralysis.

  9. Intramedullary gangliogliomas: clinical features, surgical outcomes, and neuropathic scoliosis.

    PubMed

    Yang, Chenlong; Li, Guang; Fang, Jingyi; Wu, Liang; Yang, Tao; Deng, Xiaofeng; Xu, Yulun

    2014-01-01

    Intramedullary spinal cord gangliogliomas are rare tumors composed of glial components and ganglion cells. These gangliogliomas are generally considered as slow-growing tumors, corresponding histologically to WHO grade I or II. There are few reports of large case series of intramedullary spinal cord gangliogliomas from a single center. We retrospectively reviewed a consecutive series of 18 patients with pathologically diagnosed ganglioglioma. Clinical manifestations, radiological features, treatment and follow-up data, and concomitant scoliosis were investigated. The mean age at diagnosis was 27.5 years, with a slight female predominance. The primary clinical symptoms were sensorimotor deficits. Magnetic resonance (MR) imaging manifestations varied considerably. Some associated, but not necessary, features were found, such as young age at onset, large tumor dimension, and bony changes. Scoliosis was observed in seven patients. Remnant tumor progression was observed in five patients during the follow-up period, and no deaths occurred. The last neurological evaluation showed functional improvement from preoperative status in five patients. Differential diagnosis of ganglioglioma based on MR images alone is challenging, but the combination of some characteristic features can be helpful. An accurate diagnosis of ganglioglioma depends on pathological criteria. Despite the benign course of ganglioglioma, considerable growth may affect its resectability and prognosis. The extent of resection should be meticulously planned, and the potential risk of recurrence and neurological deterioration should be evaluated. The concomitant scoliosis is noteworthy.

  10. Your Child's Development: 1 Year (12 Months)

    MedlinePlus

    ... Year-Old Your Child’s Development: 1 Year (12 Months) KidsHealth > For Parents > Your Child’s Development: 1 Year (12 Months) A A A Your little one is now ... THIS TOPIC Your Child's Checkup: 1 Year (12 Months) Your Baby's Growth: 12 Months Your Baby's Hearing, ...

  11. Influence of hemodialysis on clinical outcomes after lung transplantation

    PubMed Central

    Hennessy, Sara A.; Gillen, Jacob R.; Hranjec, Tjasa; Kozower, Benjamin D.; Jones, David R.; Kron, Irving L.; Lau, Christine L.

    2014-01-01

    Background Chronic renal failure after lung transplantation is associated with significant morbidity. However, the significance of acute kidney injury (AKI) after lung transplantation remains unclear and poorly studied. We hypothesized that hemodialysis (HD)-dependent AKI after lung transplantation is associated with significant mortality. Materials and methods We performed a retrospective review of all patients undergoing lung transplantation from July 1991 to July 2009 at our institution. Recipients with AKI (creatinine > 3 mg/dL) were identified. We compared recipients without AKI versus recipients with and without HD-dependent AKI. Kaplan-Meier survival curves were compared by log rank test. Results Of 352 lung transplant recipients reviewed at our institution, 17 developed non–HD-dependent AKI (5%) and 16 developed HD-dependent AKI (4.6%). Cardiopulmonary bypass was significantly higher in patients with HD-dependent AKI. None of the recipients who required HD had recovery of renal function. The 30-day mortality was significantly greater in recipients requiring HD (63% versus 0%; P < 0.0001). One-year mortality after transplantation was significantly increased in recipients with HD-dependent AKI compared with those with non–HD-dependent AKI (87.5% versus 17.6%; P < 0.001). Conclusions Hemodialysis is associated with mortality after lung transplantation. Fortunately, AKI that does not progress to HD commonly resolves and has a better overall survival. Avoidance, if possible, of cardiopulmonary bypass may attenuate the incidence of AKI. Aggressive measures to identify and treat early postoperative renal dysfunction and prevent progression to HD may improve outcomes after lung transplantation. PMID:23481566

  12. Iron administration and clinical outcomes in hemodialysis patients.

    PubMed

    Feldman, Harold I; Santanna, Jill; Guo, Wensheng; Furst, Howard; Franklin, Eunice; Joffe, Marshall; Marcus, Sue; Faich, Gerald

    2002-03-01

    To evaluate the impact of parenteral iron administration on the survival and rate of hospitalization of US hemodialysis patients, a nonconcurrent cohort study of 10,169 hemodialysis patients in the United States in 1994 was conducted. The main outcome measures were patient survival and rate of hospitalization. After adjusting for 23 demographic and comorbidity characteristics among 5833 patients included in multivariable analysis, bills for 10 vials showed a statistically significant elevated rate of death (adjusted RR = 1.11; 95% CI, 1.00 to 1.24; P = 0.05). Bills for 10 vials showed statistically significant elevated risk (adjusted RR = 1.12; 95% CI, 1.01 to 1.25; P = 0.03). Prescribing iron in quantities of 10 vials (1000 mg) of iron dextran over a period of 6 mo.

  13. 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.

  14. Congenital toxoplasmosis: Clinical features, outcomes, treatment, and prevention

    PubMed Central

    Singh, Sarman

    2016-01-01

    Toxoplasmosis is caused by a coccidian parasite, Toxoplasma gondii. The parasite is highly prevalent both in humans and in warm-blooded animals. Cat family animals are definitive host, and these animals excrete the infective oocysts in their feces. Humans, though not definitive host, get infection by consuming water or food contaminated with cat feces. Rarely, infection can also take place through transfusing the infected blood, through transplantation of infected organs, or transplacentally from infected mother to fetus. Transplacental infection can cause congenital infection with varied degree of clinical manifestations, which depend on the age of fetus when infection took place. Diagnosis of congenital toxoplasmosis is difficult to establish until it is suspected and laboratory investigations are carried out. In more than 75% of cases, acute infection is missed due to very mild or unnoticeable clinical symptoms and signs. In India, a prevalence rate of 22.4% (8.8-37.3%) has been reported with an overall IgM positivity of 1.43%. It is estimated that approximately between 56,737 and 176,882 children per year are born in India with a possible risk of congenital toxoplasmosis. The diagnosis of congenital toxoplasmosis can be made by serological methods which are most commonly used. The other methods are parasite isolation by culture and molecular methods. Toxoplasmosis is treatable and transplacental transmission can be prevented by spiramycin, which concentrates in the placenta. However, if infection has done any damage to the fetus or the parasite has passed the placenta, spiramycin cannot reverse the damage. Prevention remains the best remedy. PMID:27722099

  15. 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

  16. 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.

  17. Capturing and Incorporating Patient-Reported Outcomes into Clinical Trials: Practical Considerations for Clinicians.

    PubMed

    Botero, Juliana Perez; Thanarajasingam, Gita; Warsame, Rahma

    2016-10-01

    Patient centeredness as the focus of healthcare delivery requires the incorporation of patient-reported outcomes into clinical trials. Clearly defining measurable outcomes as well as selecting the most appropriate validated collection tool to use is imperative for success. Creating and validating one's own instrument is also possible, albeit more cumbersome. Meticulous data collection to avoid missing data is key, as is limiting the number of data collection points to prevent survey fatigue and using electronic systems to facilitate data gathering and analysis. Working in a multidisciplinary team that includes statisticians with expertise in patient reported outcomes is essential to navigate the complexities of statistical analysis of these variables. Use of available and emerging technologies for data collection and analysis as well as data sharing will greatly facilitate the process of incorporating patient-reported outcomes into trials and routine clinical practice.

  18. Titanium oral implants: surface characteristics, interface biology and clinical outcome

    PubMed Central

    Palmquist, Anders; Omar, Omar M.; Esposito, Marco; Lausmaa, Jukka; Thomsen, Peter

    2010-01-01

    Bone-anchored titanium implants have revolutionized oral healthcare. Surface properties of oral titanium implants play decisive roles for molecular interactions, cellular response and bone regeneration. Nevertheless, the role of specific surface properties, such as chemical and phase composition and nanoscale features, for the biological in vivo performance remains to be established. Partly, this is due to limited transfer of state-of-the-art preparation techniques to complex three-dimensional geometries, analytical tools and access to minute, intact interfacial layers. As judged by the available results of a few randomized clinical trials, there is no evidence that any particular type of oral implant has superior long-term success. Important insights into the recruitment of mesenchymal stem cells, cell–cell communication at the interface and high-resolution imaging of the interface between the surface oxide and the biological host are prerequisites for the understanding of the mechanisms of osseointegration. Strategies for development of the next generation of material surface modifications for compromised tissue are likely to include time and functionally programmed properties, pharmacological modulation and incorporation of cellular components. PMID:20591849

  19. 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

  20. 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.

  1. 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

  2. Abdominal wall abscesses in patients with Crohn's disease: clinical outcome.

    PubMed

    Neufeld, David; Keidar, Andrei; Gutman, Mordechai; Zissin, Rivka

    2006-03-01

    Abdominal wall abscess due to Crohn's Disease used to be one of the definitive indications for operative treatment. The advent of interventional radiology, the accessibility to percutaneous drainage, and the availability of new medications raised the possibility of nonoperative treatment of this condition. The clinical presentation, treatment, and follow-up of 13 patients with abdominal wall abscesses secondary to Crohn's Disease were retrospectively reviewed. During a 10-year period (1993-2003), 13 patients with abdominal wall abscess were treated. Five patients had an anterolateral abdominal wall abscess and eight had a posterior abscess (psoas). In 11 patients, 17 drainage procedures were performed: 12 percutaneous and 5 operative. Despite initial adequate drainage and resolution of the abscess, all 13 patients eventually needed resection of the offending bowel segment, which was undertaken in 12 patients. The mean time between abscess presentation and definitive operation was 2 months. Percutaneous drainage is an attractive option in most cases of abdominal abscesses. However, in Crohn's Disease patients with an abdominal wall abscess, we found a high failure rate despite initial adequate drainage. We suggest that surgical resection of the diseased bowel segment should be the definitive therapy.

  3. Clinical Presentation, Surgical Treatment, and Outcome in Radial Polydactyly.

    PubMed

    Dijkman, R R; van Nieuwenhoven, C A; Hovius, S E R; Hülsemann, W

    2016-02-01

    Radial polydactyly or 'thumb duplication' is the most common congenital upper limb anomaly ('CULA') affecting the thumb. The clinical presentation is highly diverse, ranging from an extra thumb floating on a skin bridge to complicated thumb triplications with triphalangeal, deviating, and hypoplastic components. Radial polydactyly can be classified into one of 7 osseous presentations using the Wassel classification, with type IV (45%), type II (20%), and type VII (15%) occurring most frequently. When faced with a radial polydactyly case, hand surgeons specialised in congenital anomalies must weigh the preoperative functional potential and degree of hypoplasia of both thumbs in order to decide whether to resect one thumb and reconstruct the other ('resection and reconstruction'), excise a central part of both thumbs and unite the lateral tissues into one thumb ('the Bilhaut procedure'), transfer the better-developed distal tissues of one thumb onto the better-developed proximal tissues of the other ('on-top plasty'), or discard both severely hypoplastic thumbs and pollicise the index finger. Mere excision of the hypoplastic thumb is rarely indicated since it often requires subsequent revision surgery. Even after being treated by experienced surgeons, about 15% of patients with polydactyly will need additional procedures to correct residual and/or new problems such as deviation from the longitudinal axis and joint instability. Nevertheless, radial polydactyly patients usually achieve unimpaired everyday hand function postoperatively.

  4. 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.

  5. Clinical outcomes among women with mucinous adenocarcinoma of the ovary

    PubMed Central

    Massad, L. Stewart; Gao, Feng; Hagemann, Ian; Powell, Mathew

    2016-01-01

    Background/Aims Patterns of metastasis and clinical behavior of mucinous ovarian cancers are poorly understood because of their rarity. Methods A retrospective review of records of women identified with pure mucinous invasive ovarian/tubal/peritoneal cancer 1992–2012 at one institution. Survival differences were compared using Kaplan-Meier methods with log-rank tests. Results Among 42 women with mucinous adenocarcinomas the median age was 55 years (range 33–83 years). Most cancers were well differentiated (n = 26, 68%) and stage I/II (n = 31, 74%). One of 27 women with sampled nodes had nodal metastasis; one additional woman recurred in a pelvic node. Most had no visible residual tumor after initial surgery, but of 10 women with stage III/IV cancer and documented residual, 8 had >2cm residual. Except for one woman alive with disease at last follow-up, all who recurred died of disease. Five-year survival was 83% for stage I/II cases but 29% among stage III/IV cases. Stage was a strong predictor of survival (hazard ratio of death among women with stage III/IV cancer 7.73, 95% C.I. 2.33–25.66, P<0.001 vs women with stage I/II cancer). Conclusion Mucinous ovarian cancers have a distinct biology, such that lymphadenectomy for staging is unnecessary and metastatic cancers have poor prognosis. PMID:26583769

  6. Optimal multistage designs for randomised clinical trials with continuous outcomes.

    PubMed

    Wason, James M S; Mander, Adrian P; Thompson, Simon G

    2012-02-20

    Multistage designs allow considerable reductions in the expected sample size of a trial. When stopping for futility or efficacy is allowed at each stage, the expected sample size under different possible true treatment effects (δ) is of interest. The δ-minimax design is the one for which the maximum expected sample size is minimised amongst all designs that meet the types I and II error constraints. Previous work has compared a two-stage δ-minimax design with other optimal two-stage designs. Applying the δ-minimax design to designs with more than two stages was not previously considered because of computational issues. In this paper, we identify the δ-minimax designs with more than two stages through use of a novel application of simulated annealing. We compare them with other optimal multistage designs and the triangular design. We show that, as for two-stage designs, the δ-minimax design has good expected sample size properties across a broad range of treatment effects but generally has a higher maximum sample size. To overcome this drawback, we use the concept of admissible designs to find trials which balance the maximum expected sample size and maximum sample size. We show that such designs have good expected sample size properties and a reasonable maximum sample size and, thus, are very appealing for use in clinical trials.

  7. EMT-induced metabolite signature identifies poor clinical outcome

    PubMed Central

    Putluri, Vasanta; Sphyris, Nathalie; Michailidis, George; Putluri, Nagireddy; Ambs, Stefan; Sreekumar, Arun; Mani, Sendurai A.

    2015-01-01

    Metabolic reprogramming is a hallmark of cancer. Epithelial-mesenchymal transition (EMT) induces cancer stem cell (CSC) characteristics and promotes tumor invasiveness; however relatively little is known about the metabolic reprogramming in EMT. Here we show that breast epithelial cells undergo metabolic reprogramming following EMT. Relative to control, cell lines expressing EMT transcription factors show ≥1.5-fold accumulation of glutamine, glutamate, beta-alanine and glycylleucine as well as ≥1.5-fold reduction of phosphoenolpyruvate, urate, and deoxycarnitine. Moreover, these metabolic alterations were found to be predictive of overall survival (hazard ratio = 2.3 (95% confidence interval: 1.31–4.2), logrank p-value = 0.03) and define breast cancer molecular subtypes. EMT-associated metabolites are primarily composed of anapleurotic precursors, suggesting that cells undergoing EMT have a shift in energy production. In summary, we describe a unique panel of metabolites associated with EMT and demonstrate that these metabolites have the potential for predicting clinical and biological characteristics associated with patient survival. PMID:26315396

  8. Clinical Outcomes of Endoscopic Hemostasis in Marginal Ulcer Bleeding.

    PubMed

    Yamasaki, Yasushi; Takenaka, Ryuta; Hori, Keisuke; Takemoto, Koji; Kawano, Seiji; Kawahara, Yoshiro; Fujiki, Shigeatsu; Okada, Hiroyuki

    2016-12-01

    The usefulness of endoscopy in marginal ulcer bleeding has rarely been studied, and the optimal method for preventing rebleeding is unclear. Here we assessed the efficacy of endoscopy in marginal ulcer bleeding and examined the efficacy of proton pump inhibitors (PPIs) in the prevention of rebleeding. A total of 28 patients with marginal ulcer bleeding (21 men, 7 women; median age 58.5 years) were treated by endoscopy. We analyzed the clinical characteristics, results of endoscopic therapy, characteristics of rebleeding patients, and relation between the use of PPIs and the duration of rebleeding. Sixteen patients had active bleeding. Initial hemostasis was achieved in all patients. There were no procedure-related adverse events. Rebleeding occurred in one patient within the first month and in 7 patients thereafter. There was a significant difference in the rebleeding rate between the patients who received a PPI and those who did not. In a multivariate analysis, the non-use of PPIs was a risk factor for rebleeding (hazard ratio, 6.22). Therapeutic endoscopy is effective in achieving hemostasis from marginal ulcer bleeding. PPIs may prevent rebleeding from marginal ulcers.

  9. Current therapies for Morquio A syndrome and their clinical outcomes

    PubMed Central

    Sawamoto, Kazuki; Suzuki, Yasuyuki; Mackenzie, William G.; Theroux, Mary C.; Pizarro, Christian; Yabe, Hiromasa; Orii, Kenji E.; Mason, Robert W.; Orii, Tadao; Tomatsu, Shunji

    2016-01-01

    Introduction Morquio A syndrome is characterized by a unique skeletal dysplasia, leading to short neck and trunk, pectus carinatum, laxity of joints, kyphoscoliosis, and tracheal obstruction. Cervical spinal cord compression/inability, a restrictive and obstructive airway, and/or bone deformity and imbalance of growth, are life-threatening to Morquio A patients, leading to a high morbidity and mortality. It is critical to review the current therapeutic approaches with respect to their efficacy and limitations. Areas covered Patients with progressive skeletal dysplasia often need to undergo orthopedic surgical interventions in the first two decades of life. Recently, we have treated four patients with a new surgery to correct progressive tracheal obstruction. Enzyme replacement therapy (ERT) has been approved clinically. Cell-based therapies such as hematopoietic stem cell therapy (HSCT) and gene therapy are typically one-time, permanent treatments for enzyme deficiencies. We report here on four Morquio A patients treated with HSCT approved in Japan and followed for at least ten years after treatment. Gene therapy is under investigation on mouse models but not yet available as a therapeutic option. Expert opinion ERT and HSCT in combination with surgical intervention(s) are a therapeutic option for Morquio A; however, the approach for bone and cartilage lesion remains an unmet challenge. PMID:28217429

  10. Definitions and outcome measures of clinical trials regarding opioid-induced constipation: a systematic review.

    PubMed

    Gaertner, Jan; Siemens, Waldemar; Camilleri, Michael; Davies, Andrew; Drossman, Douglas A; Webster, Lynn R; Becker, Gerhild

    2015-01-01

    Opioid-induced constipation (OIC) is a frequent symptom in patients treated with opioids and impacts the patients' quality of life. However, there is no generally accepted definition for OIC. The aims of this study were to identify definitions for OIC in clinical trials and Cochrane Reviews and to compile assessment tools and outcome measures that were used in clinical trials. In a systematic review, 5 databases (MEDLINE, PubMed, The Cochrane Library, Web of Science, and EMBASE) were searched to identify clinical trials assessing OIC in adult patients or healthy volunteers. Studies published between 1993 and August 2013 were included. A total of 1488 studies were retrieved and 47 publications were included in the analysis. A minority of the publications (n=16, 34%) provided a clear definition for OIC. The definitions were highly variable and the present or recent history of opioid therapy was frequently (n=6, 38%) not included in these definitions. Of 46 clinical trials, 17 (37%) relied exclusively on objective measures such as bowel movement frequency, whereas another 17 studies additionally included patient-reported outcome measures such as, "feeling of incomplete bowel evacuation." Few trials (n=7, 15%) assessed the patient-reported global burden of OIC. Standard definitions and outcome measures are necessary (i) for consistency in OIC diagnosis in clinical practice and clinical trials; and (ii) to assure comparability of trial findings (eg, in meta-analyses). An OIC definition and outcome measures are proposed.

  11. Evidence-Based Rationale for Ankle Cartilage Allograft Replacement: A Systematic Review of Clinical Outcomes.

    PubMed

    Johnson, Pierce; Lee, Daniel K

    2015-01-01

    The treatment of ankle arthritis remains controversial. Ankle cartilage allograft replacement is a novel and complex procedure. Many clinical studies have shown some level of promise, as well complications. We performed a systematic review of the clinical outcomes to describe and assess the different techniques and clinical outcomes for ankle cartilage allograft replacement. We performed a review of the published studies using MEDLINE(®) by way of PubMed(®) and Google Scholar(®) from January 2000 through October 2014, ranging from case reports to clinical studies. The inclusion criteria consisted of ankle cartilage allograft procedures with objective findings and clinical outcome scoring and complication and fusion rates and excluded nonallograft synthetic graft techniques, bone substitutes or expanders, review reports, and technique instructional manuals. Evidence with the combination of objective findings and clinical outcomes for all 3 type of allograft replacement (osteochondral, unipolar, and bipolar) is lacking. Several techniques for cartilage fixation have been described, including absorbable and metallic fixation. Most of the studies reported many occurrences and a variety of complications. A myriad of techniques for ankle cartilage allograft replacement exists. The results from the present systematic review of the published studies appear promising; however, the lack of statistical power and inconsistent documentation made it difficult to determine the superiority of any one intervention compared with another for the treatment of ankle arthritis.

  12. Dietary sodium and clinical outcome in hemodialysis: where do we stand and what is next?

    PubMed

    Rambod, Mehdi; Tolouian, Ramin

    2012-07-01

    The association of dietary sodium and outcome is widely studied in the general population, but less is known in hemodialysis patients. The evidence supporting daily dietary sodium intake of 2 g on hemodialysis is not strong. Mc Causland et al. found that higher dietary sodium intake was marginally associated with a higher ultrafiltration requirement and mortality, but not with blood pressure. Well-designed clinical trials are needed to examine the association of dietary sodium modification and outcomes in hemodialysis patients.

  13. 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

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

    PubMed Central

    2016-01-01

    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

  15. 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

  16. User-centered design in clinical handover: exploring post-implementation outcomes for clinicians.

    PubMed

    Wong, Ming Chao; Cummings, Elizabeth; Turner, Paul

    2013-01-01

    This paper examines the outcomes for clinicians from their involvement in the development of an electronic clinical hand-over tool developed using principles of user-centered design. Conventional e-health post-implementation evaluations tend to emphasize technology-related (mostly positive) outcomes. More recently, unintended (mostly negative) consequences arising from the implementation of e-health technologies have also been reported. There remains limited focus on the post-implementation outcomes for users, particularly those directly involved in e-health design processes. This paper presents detailed analysis and insights into the outcomes experienced post-implementation by a cohort of junior clinicians involved in developing an electronic clinical handover tool in Tasmania, Australia. The qualitative methods used included observations, semi-structured interviews and analysis of clinical handover notes. Significantly, a number of unanticipated flow-on effects were identified that mitigated some of the challenges arising during the design and implementation of the tool. The paper concludes by highlighting the importance of identifying post-implementation user outcomes beyond conventional system adoption and use and also points to the need for more comprehensive evaluative frameworks to encapsulate these broader socio-technical user outcomes.

  17. Cost Structure and Clinical Outcome of a Stem Cell Transplantation Program in a Developing Country: The Experience in Northeast Mexico

    PubMed Central

    Heredia-Salazar, Alberto Carlos; Cantú-Rodríguez, Olga G.; Gutiérrez-Aguirre, Homero; Villarreal-Villarreal, César Daniel; Mancías-Guerra, Consuelo; Herrera-Garza, José Luís; Gómez-Almaguer, David

    2015-01-01

    Background and Objective. Hematopoietic stem cell transplantation (HSCT) in developing countries is cost-limited. Our primary goal was to determine the cost structure for the HSCT program model developed over the last decade at our public university hospital and to assess its clinical outcomes. Materials and Methods. Adults and children receiving an allogeneic hematopoietic stem cell transplant from January 2010 to February 2011 at our hematology regional reference center were included. Laboratory tests, medical procedures, chemotherapy drugs, other drugs, and hospitalization costs were scrutinized to calculate the total cost for each patient and the median cost for the procedure. Data regarding clinical evolution were incorporated into the analysis. Physician fees are not charged at the institution and therefore were not included. Results. Fifty patients were evaluated over a 1-year period. The total estimated cost for an allogeneic HSCT was $12,504. The two most expensive diseases to allograft were non-Hodgkin lymphoma ($11,760 ± $2,236) for the malignant group and thalassemia ($12,915 ± $5,170) for the nonmalignant group. Acute lymphoblastic leukemia ($11,053 ± 2,817) and acute myeloblastic leukemia ($10,251 ± $1,538) were the most frequent indications for HSCT, with 11 cases each. Median out-of-pocket expenses were $1,605, and 1-year follow-up costs amounted to $1,640, adding up to a total cost of $15,749 for the first year. The most expensive components were drugs and laboratory tests. Conclusion. Applying the cost structure described, HSCT is an affordable option for hematological patients living in a developing country. PMID:25746343

  18. Femoro-acetabular impingement clinical research: is a composite outcome the answer?

    PubMed

    Ayeni, Olufemi R; Sansone, Mikael; de Sa, Darren; Simunovic, Nicole; Bedi, Asheesh; Kelly, Bryan T; Farrokhyar, Forough; Karlsson, Jon

    2016-01-01

    Femoro-acetabular impingement (FAI) is increasingly recognized as an important cause of hip pain in the young adult. However, the methods of evaluating the efficacy of surgical intervention are often not validated and/or inconsistently reported. Important clinical, gait, radiographic and biomarker outcomes are discussed. This article (1) presents the rationale for considering a composite outcome for FAI patients; (2) examines a variety of important end points currently used to evaluate FAI surgery; (3) discusses a strategy to generate a composite outcome by combining these end points; and (4) highlights the challenges and current areas of controversy that such an approach to evaluating symptomatic FAI patients may present.

  19. PREP for Strong Bonds: A review of outcomes from a randomized clinical trial

    PubMed Central

    Allen, Elizabeth; Stanley, Scott; Rhoades, Galena; Markman, Howard

    2015-01-01

    To help address the relationship needs of service members, there have been a number of programs offered within active duty and veteran contexts. One program, offered within the Strong Bonds portfolio delivered by Army Chaplains, is PREP for Strong Bonds (PREP = the Prevention and Relationship Education Program). PREP has a number of empirically based and tested variants. This article reviews the disseminated research regarding results from a large randomized clinical trial designed to test the effectiveness of PREP for Strong Bonds. From a sample of 662 Army couples drawn from two sites, outcome papers have focused on different subsamples, marital outcomes, follow up time points, and moderators. Reviewing these disseminated outcomes, we conclude that PREP for Strong Bonds has significant divorce reduction effects at one site; these divorce effects were found at both one and two years post intervention, and were moderated by factors such as minority status, economic strain, and cohabitation history of the couple. In terms of marital quality outcomes, some modest overall effects were found pre to post intervention, but there were no overall marital quality outcome effects two years post intervention. However, marital quality outcomes are significantly moderated by infidelity and cohabitation history, with couples reporting these risk factors showing greater positive marital quality outcomes. These results to date are discussed in terms of clinical and research implications as well as directions for future work, such as examining longer term preventative effects. PMID:26366041

  20. Clinical outcomes based on multigene profiling in metastatic breast cancer patients

    PubMed Central

    Ueno, Naoto T.; Wathoo, Chetna; Chen, Huiqin; Shariati, Maryam; Wei, Caimiao; Alvarez, Ricardo H.; Moulder, Stacy L.; Sahin, Aysegul A.; Roy-Chowdhuri, Sinchita; Chavez-MacGregor, Mariana; Litton, Jennifer K.; Valero, Vincent; Luthra, Raja; Zeng, Jia; Shaw, Kenna R.; Mendelsohn, John; Mills, Gordon B.; Tripathy, Debu; Meric-Bernstam, Funda

    2016-01-01

    BACKGROUND Identifying the clinical impact of recurrent mutations can help define their role in cancer. Here, we identify frequent hotspot mutations in metastatic breast cancer (MBC) patients and associate them with clinical outcomes. PATIENTS AND METHODS Hotspot mutation testing was conducted in 500 MBC patients using an 11 gene (N = 126) and/or 46 or 50 gene (N = 391) panel. Patients were stratified by hormone receptor (HR) and human epidermal growth factor 2 (HER2) status. Clinical outcomes were retrospectively collected. RESULTS Hotspot mutations were most frequently detected in TP53 (30%), PIK3CA (27%) and AKT1 (4%). Triple-negative breast cancer (TNBC) patients had the highest incidence of TP53 (58%) and the lowest incidence of PIK3CA (9%) mutations. TP53 mutation was associated with shorter relapse-free survival (RFS) (median 22 vs 42months; P < 0.001) and overall survival (OS) from diagnosis of distant metastatic disease (median 26 vs 51months; P < 0.001). Conversely, PIK3CA mutation was associated with a trend towards better clinical outcomes including RFS (median 41 vs 30months; P = 0.074) and OS (52 vs 40months; P = 0.066). In HR-positive patients, TP53 mutation was again associated with shorter RFS (median 30 vs 46months; P = 0.017) and OS (median 30 vs 55months; P = 0.001). When multivariable analysis was performed for RFS and OS, TP53 but not PIK3CA mutation remained a significant predictor of outcomes in the overall cohort and in HR-positive patients. CONCLUSIONS Clinical hotspot sequencing identifies potentially actionable mutations. In this cohort, TP53 mutation was associated with worse clinical outcomes, while PIK3CA mutation did not remain a significant predictor of outcomes after multivariable analysis. PMID:27806348

  1. Clinical outcomes of osteomyelitis patients infected with methicillin-resistant Staphylococcus aureus USA-300 strains.

    PubMed

    Peyrani, P; Allen, M; Seligson, D; Roberts, C; Chen, A; Haque, N; Zervos, M; Wiemken, T; Harting, J; Christensen, D; Ramirez, R

    2012-03-01

    Methicillin-resistant Staphylococcus aureus (MRSA) USA-300 strains have emerged as an important cause of community-acquired infections. These strains have been recognized as an etiology of osteomyelitis but data on their incidence and outcomes are limited. We retrospectively studied the incidence and clinical outcomes of MRSA USA-300 osteomyelitis in patients at the University of Louisville Hospital and the Henry Ford Health System between January 2007 and March 2008. Pulsed-field gel electrophoresis was used to determine USA type. Clinical outcomes were defined as management success versus failure at 12 months. Chi-square tests, Fisher exact tests, and Mann-Whitney tests were used to compare patient characteristics on the basis of clinical outcomes and USA type. Of the 50 patients with MRSA osteomyelitis, 27 (54%) had the USA-300 strain. Clinical failure was identified in 22% (6/27) of the patients with MRSA USA-300 and in 30% (7/23) of the patients with MRSA non-USA-300 osteomyelitis (P = .509). Our results showed that MRSA USA-300 is a significant etiology of MRSA osteomyelitis. With current surgical and medical management, outcomes of patients with MRSA USA-300 osteomyelitis are similar to those of patients with MRSA non-USA-300 osteomyelitis.

  2. An audit of first-aid treatment of pediatric burns patients and their clinical outcome.

    PubMed

    Cuttle, Leila; Kravchuk, Olena; Wallis, Belinda; Kimble, Roy M

    2009-01-01

    This study describes the first aid used and clinical outcomes of all patients who presented to the Royal Children's Hospital, Brisbane, Australia in 2005 with an acute burn injury. A retrospective audit was performed with the charts of 459 patients and information concerning burn injury, first-aid treatment, and clinical outcomes was collected. First aid was used on 86.1% of patients, with 8.7% receiving no first aid and unknown treatment in 5.2% of cases. A majority of patients had cold water as first aid (80.2%), however, only 12.1% applied the cold water for the recommended 20 minutes or longer. Recommended first aid (cold water for >or=20 minutes) was associated with significantly reduced reepithelialization time for children with contact injuries (P=.011). Superficial depth burns were significantly more likely to be associated with the use of recommended first aid (P=.03). Suboptimal treatment was more common for children younger than 3.5 years (P<.001) and for children with friction burns. This report is one of the few publications to relate first-aid treatment to clinical outcomes. Some positive clinical outcomes were associated with recommended first-aid use; however, wound outcomes were more strongly associated with burn depth and mechanism of injury. There is also a need for more public awareness of recommended first-aid treatment.

  3. Early clinical outcome and complications related to balloon kyphoplasty.

    PubMed

    Bergmann, Martin; Oberkircher, Ludwig; Bliemel, Christopher; Frangen, Thomas Manfred; Ruchholtz, Steffen; Krüger, Antonio

    2012-05-09

    The treatment of painful osteoporotic vertebral compression fractures using transpedicular cement augmentation has grown significantly over the last two decades. The benefits of balloon kyphoplasty compared to conservative treatment remain controversial and are discussed in the literature. The complication rates of vertebroplasty and kyphoplasty are considered to be low. The focus of this study was the analysis of acute and clinically relevant complications related to this procedure. In our department, all patients treated between February 2002 and February 2011 with percutaneous cement augmentation (372 patients, 522 augmented vertebral bodies) were prospectively recorded. Demographic data, comorbidities, fracture types, intraoperative data and all complications were documented. The pre- and postoperative pain-level and neurological status (Frankel-Score) were evaluated. All patients underwent a standardized surgical procedure. Two hundred and ninety-seven patients were treated solely by balloon kyphoplasty; 216 females (72.7%) and 81 males (27.3%). Average patient age was 76.21 years (±10.71, range 35-98 years). Average American Society Anestesiologists score was 3.02. According to the Orthopedic Trauma Association classification, there were 69 A 1.1 fractures, 177 A 1.2 fractures, 178 A 3.1.1 fractures and 3 A 3.1.3 fractures. Complications were divided into preoperative, intraoperative and postoperative events. There were 4 preoperative complications: 3 patients experienced persistent pain after the procedure. In one case, the pedicles could not be visualized during the procedure and the surgery was terminated. One hundred and twenty-nine (40.06%) of the patients showed intraoperative cement leaking outside the vertebras, one severe hypotension and tachycardia as reaction to the inflation of the balloons, and there was one cardiac arrest during surgery. Postoperative subcutaneous hematomas were observed in 3 cases, 13 patients developed a urinary tract

  4. The application of Rasch measurement theory to psychiatric clinical outcomes research

    PubMed Central

    Barbic, Skye P.; Cano, Stefan J.

    2016-01-01

    This commentary argues the importance of robust, meaningful assessment of clinical and functional outcomes in psychiatry. Outcome assessments should be fit for the purpose of measuring relevant concepts of interest in specific clinical settings. As well, the measurement model selected to develop and test assessments can be critical for guiding care. Three types of measurement models are presented: classical test theory, item response theory, and Rasch measurement theory. To optimise current diagnostic and treatment practices in psychiatry, careful consideration of these models is warranted.. PMID:27752341

  5. Clinical and Economic Outcomes of Thyroid Surgery in Elderly Patients: A Systematic Review

    PubMed Central

    Sullivan, Michael C.; Roman, Sanziana A.; Sosa, Julie A.

    2012-01-01

    The U.S. population is undergoing a dramatic shift in demographics, with a rise in the proportion of elderly Americans. Given an increased prevalence of thyroid disease and malignancy with age, understanding the safety of thyroid surgery in this age group is increasingly pertinent. There remains disagreement regarding the clinical outcomes of elderly patients after thyroidectomy and the applicability of single-institution cohorts to the population at large. This paper reviews the epidemiology of thyroid disease in the elderly, current surgical indications and practice patterns, and the clinical and economic outcomes of elderly patients with thyroid disease after surgical intervention. PMID:22779035

  6. 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.

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

    PubMed

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

    2013-01-01

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

  8. CAsubtype: An R Package to Identify Gene Sets Predictive of Cancer Subtypes and Clinical Outcomes.

    PubMed

    Kong, Hualei; Tong, Pan; Zhao, Xiaodong; Sun, Jielin; Li, Hua

    2017-01-21

    In the past decade, molecular classification of cancer has gained high popularity owing to its high predictive power on clinical outcomes as compared with traditional methods commonly used in clinical practice. In particular, using gene expression profiles, recent studies have successfully identified a number of gene sets for the delineation of cancer subtypes that are associated with distinct prognosis. However, identification of such gene sets remains a laborious task due to the lack of tools with flexibility, integration and ease of use. To reduce the burden, we have developed an R package, CAsubtype, to efficiently identify gene sets predictive of cancer subtypes and clinical outcomes. By integrating more than 13,000 annotated gene sets, CAsubtype provides a comprehensive repertoire of candidates for new cancer subtype identification. For easy data access, CAsubtype further includes the gene expression and clinical data of more than 2000 cancer patients from TCGA. CAsubtype first employs principal component analysis to identify gene sets (from user-provided or package-integrated ones) with robust principal components representing significantly large variation between cancer samples. Based on these principal components, CAsubtype visualizes the sample distribution in low-dimensional space for better understanding of the distinction between samples and classifies samples into subgroups with prevalent clustering algorithms. Finally, CAsubtype performs survival analysis to compare the clinical outcomes between the identified subgroups, assessing their clinical value as potentially novel cancer subtypes. In conclusion, CAsubtype is a flexible and well-integrated tool in the R environment to identify gene sets for cancer subtype identification and clinical outcome prediction. Its simple R commands and comprehensive data sets enable efficient examination of the clinical value of any given gene set, thus facilitating hypothesis generating and testing in biological and

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

    PubMed

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

    2014-01-01

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

  10. 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

  11. Clinical outcomes of single versus double blastocyst transfer in fresh and vitrified-warmed cycles

    PubMed Central

    Eum, Jin Hee; Park, Jae Kyun; Kim, So Young; Paek, Soo Kyung; Seok, Hyun Ha; Chang, Eun Mi; Lee, Woo Sik

    2016-01-01

    Objective Assisted reproductive technology has been associated with an increase in multiple pregnancies. The most effective strategy for reducing multiple pregnancies is single embryo transfer. Beginning in October 2015, the National Supporting Program for Infertility in South Korea has limited the number of embryos that can be transferred per in vitro fertilization (IVF) cycle depending on the patient's age. However, little is known regarding the effect of age and number of transferred embryos on the clinical outcomes of Korean patients. Thus, this study was performed to evaluate the effect of the number of transferred blastocysts on clinical outcomes. Methods This study was carried out in the Fertility Center of CHA Gangnam Medical Center from January 2013 to December 2014. The clinical outcomes of 514 women who underwent the transfer of one or two blastocysts on day 5 after IVF and of 721 women who underwent the transfer of one or two vitrified-warmed blastocysts were analyzed retrospectively. Results For both fresh and vitrified-warmed cycles, the clinical pregnancy rate and live birth or ongoing pregnancy rate were not significantly different between patients who underwent elective single blastocyst transfer (eSBT) and patients who underwent double blastocyst transfer (DBT), regardless of age. However, the multiple pregnancy rate was significantly lower in the eSBT group than in the DBT group. Conclusion The clinical outcomes of eSBT and DBT were equivalent, but eSBT had a lower risk of multiple pregnancy and is, therefore, the best option. PMID:27689039

  12. The design, rationale, and baseline characteristics of a nationwide cohort registry in China: blood pressure and clinical outcome in TIA or ischemic stroke

    PubMed Central

    Xu, Jie; Liu, Yi; Tao, Yongli; Xie, Xuewei; Gu, Hongqiu; Pan, Yuesong; Zhao, Xingquan; Wang, Yongjun; Yan, Aoshuang; Wang, Yilong

    2016-01-01

    Background The relationship between poststroke blood pressure (BP) and clinical outcomes in ischemic stroke (IS) is still controversial. However, there is no large BP database for IS or transient ischemic attack (TIA) in China. This study aims to describe the rationale, study design, and baseline characteristics of a nationwide BP database in IS or TIA patients in China. Materials and methods The BOSS (blood pressure and clinical outcome in TIA or ischemic stroke) study was a hospital-based, prospective cohort study aiming to assess BP parameters and clinical outcome in IS/TIA patients. BP parameters were based on office BP, ambulatory BP, and home BP. Clinical outcomes included stroke recurrence, combined vascular events, and disability. Electronic case-report forms were used to record baseline and follow-up data. The patients were followed up for clinical outcomes at 3 months through face-to-face interview and at 12 months by telephone. Results Between October 2012 and February 2014, the BOSS registry recruited 2,608 patients from 61 hospitals, with a mean age of 62.5 years, 32.4% of whom were female, 88.9% with an entry diagnosis of IS, and 86% diagnosed with hypertension. The rates of patients lost-to-follow-up were 3.1% at 3 months and 5.1% at 1 year; 93% of patients completed ambulatory BP monitoring during hospitalization and 94.7% finished a 3-month BP diary. Conclusion The BOSS registry will provide important evidence about BP management in the acute phase and secondary prevention for IS/TIA patients. PMID:27942205

  13. 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

  14. Clinical presentation and treatment outcome of retinoblastoma in children of South Western China

    PubMed Central

    Gao, Jingge; Zeng, Jihong; Guo, Bo; He, Weimin; Chen, Jun; Lu, Fang; Chen, Danian

    2016-01-01

    Abstract To study the clinical presentation and treatment outcome among children in South Western China with retinoblastoma (RB) and to determine factors predictive of poor outcome. A retrospective review of children diagnosed with RB from 2006 to 2015 at West China Hospital was undertaken. Demographic and clinical characteristics and treatment outcomes were studied. A total of 253 patients (unilateral 80.2%, bilateral 19.8%) were studied. Twenty six patients (10.3%) were from minority ethnic groups of China. The median onset age was 21 months. Leukocoria was the most common presenting sign (71%). Tumors were intraocular in 91.3% cases, extraocular in 8.7% cases. Extraocular RB patients had a longer median lag period than intraocular patients (9 months vs 2 months, P < 0.0001). In the intraocular group, 89.5% were advanced group D or E diseases. Enucleation was the major treatment for intraocular RB. However, over 10 years, the enucleation rate decreased constantly while more patients received chemotherapy. The Kaplan–Meier survival probability was 87.8%, 81.4%, and 74.8% at 3 years, 5 years, and 10 years, respectively. On Cox regression analysis, extraocular RB (P = 0.0008) and treatment abandonment (P < 0.0001) were associated with poor outcome; bilateral RB (P = 0.0116) and advanced pathological grade pT4 (P = 0.0011) were associated with poor outcome of intraocular RB. Most RB patients from South Western China were diagnosed at advanced clinical stage. Delayed presentation is related to extraocular RB which is a risk factor for poor outcome. Chemotherapy increased the eye salvage but had no effects to overall survival. Education for parents and general physicians for the early signs of RB (such as leukocoria), therapeutic strategy and treatment outcomes of RB may promote early diagnosis, improve the compliance, and outcome. PMID:27759657

  15. Clinical presentation and treatment outcome of retinoblastoma in children of South Western China.

    PubMed

    Gao, Jingge; Zeng, Jihong; Guo, Bo; He, Weimin; Chen, Jun; Lu, Fang; Chen, Danian

    2016-10-01

    To study the clinical presentation and treatment outcome among children in South Western China with retinoblastoma (RB) and to determine factors predictive of poor outcome.A retrospective review of children diagnosed with RB from 2006 to 2015 at West China Hospital was undertaken. Demographic and clinical characteristics and treatment outcomes were studied.A total of 253 patients (unilateral 80.2%, bilateral 19.8%) were studied. Twenty six patients (10.3%) were from minority ethnic groups of China. The median onset age was 21 months. Leukocoria was the most common presenting sign (71%). Tumors were intraocular in 91.3% cases, extraocular in 8.7% cases. Extraocular RB patients had a longer median lag period than intraocular patients (9 months vs 2 months, P < 0.0001). In the intraocular group, 89.5% were advanced group D or E diseases. Enucleation was the major treatment for intraocular RB. However, over 10 years, the enucleation rate decreased constantly while more patients received chemotherapy. The Kaplan-Meier survival probability was 87.8%, 81.4%, and 74.8% at 3 years, 5 years, and 10 years, respectively. On Cox regression analysis, extraocular RB (P = 0.0008) and treatment abandonment (P < 0.0001) were associated with poor outcome; bilateral RB (P = 0.0116) and advanced pathological grade pT4 (P = 0.0011) were associated with poor outcome of intraocular RB.Most RB patients from South Western China were diagnosed at advanced clinical stage. Delayed presentation is related to extraocular RB which is a risk factor for poor outcome. Chemotherapy increased the eye salvage but had no effects to overall survival. Education for parents and general physicians for the early signs of RB (such as leukocoria), therapeutic strategy and treatment outcomes of RB may promote early diagnosis, improve the compliance, and outcome.

  16. Clinical characteristics, precipitating factors, management and outcome of patients with prior stroke hospitalised with heart failure: an observational report from the Middle East

    PubMed Central

    Khafaji, Hadi A R; Sulaiman, Kadhim; Singh, Rajvir; AlHabib, Khalid F; Asaad, Nidal; Alsheikh-Ali, Alawi; Al-Jarallah, Mohammed; Bulbanat, Bassam; AlMahmeed, Wael; Ridha, Mustafa; Bazargani, Nooshin; Amin, Haitham; Al-Motarreb, Ahmed; AlFaleh, Hussam; Elasfar, Abdelfatah; Panduranga, Prashanth; Al Suwaidi, Jassim

    2015-01-01

    Objectives The purpose of this study is to report the prevalence, clinical characteristics, precipitating factors, management and outcome of patients with prior stroke hospitalised with acute heart failure (HF). Design Retrospective analysis of prospectively collected data. Setting Data were derived from Gulf CARE (Gulf aCute heArt failuRe rEgistry), a prospective multicentre study of consecutive patients hospitalised with acute HF in 2012 in seven Middle Eastern countries and analysed according to the presence or absence of prior stroke; demographics, management and outcomes were compared. Participants A total of 5005 patients with HF. Outcome measures In-hospital and 1-year outcome. Results The prevalence of prior stroke in patients with HF was 8.1%. Patients with stroke with HF were more likely to be admitted under the care of internists rather than cardiologists. When compared with patients without stroke, patients with stroke were more likely to be older and to have diabetes mellitus, hypertension, atrial fibrillation, hyperlipidaemia, chronic kidney disease, ischaemic heart disease, peripheral arterial disease and left ventricular dysfunction (p=0.001 for all). Patients with stroke were less likely to be smokers (0.003). There were no significant differences in terms of precipitating risk factors for HF hospitalisation between the two groups. Patients with stroke with HF had a longer hospital stay (mean±SD days; 11±14 vs 9±13, p=0.03), higher risk of recurrent strokes and 1-year mortality rates (32.7% vs 23.2%, p=0.001). Multivariate logistic regression analysis showed that stroke is an independent predictor of in-hospital and 1-year mortality. Conclusions This observational study reports high prevalence of prior stroke in patients hospitalised with HF. Internists rather than cardiologists were the predominant caregivers in this high-risk group. Patients with stroke had higher risk of in-hospital recurrent strokes and long-term mortality rates. Trial

  17. Short term outcome and risk factors for adverse clinical outcomes in adults with severe acute respiratory syndrome (SARS)

    PubMed Central

    Chan, J; Ng, C; Chan, Y; Mok, T; Lee, S; Chu, S; Law, W; Lee, M; Li, P

    2003-01-01

    Background: Severe acute respiratory syndrome (SARS) was diagnosed in Hong Kong in over 1700 patients between March and early June 2003. Methods: 115 patients diagnosed with SARS were admitted to Queen Elizabeth Hospital, a large regional hospital in Hong Kong, from March 2003, of whom 100 were either discharged or were dead at 31 May. The patients were prospectively studied after admission to assess their short term outcomes and the risk factors associated with adverse outcomes, defined as death or the need for mechanical ventilation Results: At the time of writing 18 patients had died, with a crude mortality rate of 15.7% and a 21 day mortality of 10% (standard error 3%). Thirty nine patients (34%) were admitted to the intensive care unit, 30 of whom (26%) required mechanical ventilation. Multivariate analysis showed that age above 60 (hazards ratio (HR) 3.5, 95% CI 1.2 to 10.2; p=0.02), presence of diabetes mellitus or heart disease (HR 9.1, 95% CI 2.8 to 29.1; p<0.001), and the presence of other comorbid conditions (HR 5.2, 95% CI 1.4 to 19.7; p=0.01) were independently associated with mortality. However, only the presence of diabetes mellitus and/or cardiac disease (HR 7.3, 95% CI 3.1 to 17.4; p<0.001) was associated with adverse outcomes as a whole. Conclusion: SARS is a new disease entity that carries significant morbidity and mortality. Specific clinical and laboratory parameters predicting unfavourable outcomes have been identified. PMID:12885985

  18. Minimal Clinically Important Differences of Three Patient-Rated Outcomes Instruments

    PubMed Central

    Sorensen, Amelia; Howard, Daniel; Hui Tan, Wen; Ketchersid, Jeffrey; Calfee, Ryan P.

    2013-01-01

    Purpose Patient-rated instruments are increasingly used to measure orthopaedic outcomes. However, the clinical relevance of modest score changes on such instruments is often unclear. This study was designed to define the minimal clinically important differences (MCID) of the Disabilities of the Arm, Shoulder, and Hand (DASH), QuickDASH, and Patient Rated Wrist Evaluation (PRWE) for atraumatic conditions of the hand, wrist, and forearm. Methods One hundred two patients undergoing nonoperative treatment for isolated tendonitis, arthritis, or nerve compression syndromes from the forearm to the hand were analyzed prospectively. Patients completed the DASH, Quick DASH (subset of DASH), and PRWE at enrollment, 2 weeks (n=78 used in analysis), and 4 weeks (n=24 used in analysis) after initiating treatment by telephone. Patients reporting clinical improvement each contributed a single data point categorized as no change (n=41), minimal improvement (n=30), or marked improvement (n=31) via a validated anchor-based approach. The minimal clinically important difference was calculated as the mean change score for each outcome measure in the minimal improvement group. Results The MCID (95%CI) for the DASH was 10 (5-15). The MCID for the Quick DASH was 14 (9-20). The MCID was 14 (8-20) for the PRWE. MCID values were significantly different from changes in these outcome measures at times of either no change or marked improvement. MCID values positively correlated with baseline outcome measure scores to a greater degree than final outcome measure scores. Discussion Longitudinal changes on the DASH of 10 points, the Quick DASH of 14 points, and the PRWE of 14 points represent minimal clinically important changes. We recommend application of these MCID values for group-level analysis when conducting research and interpreting data examining groups of patients as opposed to assessing individual patients. These MCID values may provide a basis for sample size calculations for future

  19. The effects of clinical practice guidelines on patient outcomes in primary care: a systematic review

    PubMed Central

    Worrall, G; Chaulk, P; Freake, D

    1997-01-01

    OBJECTIVE: To assess the evidence for the effectiveness of clinical practice guidelines (CPGs) in improving patient outcomes in primary care. DATA SOURCES: A search of the MEDLINE, HEALTHPLAN, CINAHL and FAMLI databases was conducted to identify studies published between Jan. 1, 1980, and Dec. 31, 1995, concerning the use of guidelines in primary medical care. The keywords used in the search were "clinical guidelines," "primary care," "clinical care," "intervention," "randomized controlled trial" and "effectiveness." STUDY SELECTION: Studies of the use of CPGs were selected if they involved a randomized experimental or quasi-experimental method, concerned primary care, were related to clinical care and examined patient outcomes. Of 91 trials of CPGs identified through the search, 13 met the criteria for inclusion in the critical appraisal. DATA EXTRACTION: The following data were extracted, when possible, from the 13 trials: country and setting, number of physicians, number of patients (and the proportion followed to completion), length of follow-up, study method (including random assignment method), type of intervention, medical condition treated and effect on patient outcomes (including clinical and statistical significance, with confidence intervals). DATA SYNTHESIS: The most common conditions studied were hypertension (7 studies), asthma (2 studies) and cigarette smoking (2 studies). Four of the studies followed nationally developed guidelines, and 9 used locally developed guidelines. Six studies involved computerized or automated reminder systems, whereas the others relied on small-group workshops and education sessions. Only 5 of the 13 trials (38%) produced statistically significant results. CONCLUSION: There is very little evidence that the use of CPGs improves patient outcomes in primary medical care, but most studies published to date have used older guidelines and methods, which may have been insensitive to small changes in outcomes. Research is needed

  20. Clinical Infectious Outcomes Associated with Biofilm-related Infections: a Retrospective Chart Review

    DTIC Science & Technology

    2015-06-07

    information from the associated patients, including demographics, comorbidities, antibiotic usage, laboratory values, and clinical infectious outcomes, was...requires higher doses or combination of antibiotics , and removal of foreign bodies when implicated in device re- lated infections [1, 6]. Despite an...co-infecting organisms, as well as receipt of antibiotics prior to recovery of clinical isolates. The anatomic source of isolates and their asso

  1. Durable left ventricular assist device therapy in advanced heart failure: Patient selection and clinical outcomes

    PubMed Central

    Shah, Sachin P.; Mehra, Mandeep R.

    2016-01-01

    The increasing adoption of left ventricular assist devices (LVADs) into clinical practice is related to a combination of engineering advances in pump technology and improvements in understanding the appropriate clinical use of these devices in the management of patients with advanced heart failure. This review intends to assist the clinician in identifying candidates for LVAD implantation, to examine long-term outcomes and provide an overview of the common complications related to use of these devices. PMID:27056652

  2. Comprehensive clinical evaluation as an outcome assessment for a graduate orthodontics program.

    PubMed

    Pinskaya, Yuliya B; Hsieh, Tsung-Ju; Roberts, W Eugene; Hartsfield, James K

    2004-11-01

    To supplement the American Board of Orthodontics (ABO) objective grading system (OGS) for posttreatment dental casts and panoramic radiographs, a comprehensive clinical assessment (CCA) method was developed to assess facial form, dental esthetics, vertical dimension, arch form, periodontium preservation, root resorption, and treatment efficiency. The sum of the CCA and the ABO OGS scores was defined as the clinical outcome. To determine a 3-year baseline for treatment outcomes in a graduate orthodontic program, the posttreatment records of 521 consecutive patients were evaluated. The mean ABO OGS score for the entire sample was 34.4 points: 32.4, 33.1, and 37.8 points for 1998, 1999, and 2000, respectively. The mean CCA score for the entire sample was 4.67 points: 2.96, 5.13, and 6.15 points for 1998, 1999, and 2000, respectively. Corresponding ABO OGS and CCA scores showed a progressive decrease in the quality of finished cases that was associated with a treatment time increase from 28.9 to 39.3 months. Overall, longer active treatment times resulted in a diminished clinical outcome, primarily due to "patient burn-out." Scoring of all finished cases is an effective means for determining clinical outcomes. However, the data suggest that, in initiating a clinical grading program, it is important to establish a multiyear baseline. Patients who are progressing well in treatment tend to be finished by the time the current class graduates, and the problem patients are transferred. Because long treatment times are associated with diminished clinical outcomes, it is often in the best interest of the uncooperative patient to terminate treatment rather than extend active mechanics in an attempt to achieve a better result.

  3. Leveraging epidemiology and clinical studies of cancer outcomes: recommendations and opportunities for translational research.

    PubMed

    Elena, Joanne W; Travis, Lois B; Simonds, Naoko I; Ambrosone, Christine B; Ballard-Barbash, Rachel; Bhatia, Smita; Cerhan, James R; Hartge, Patricia; Heist, Rebecca S; Kushi, Lawrence H; Lash, Timothy L; Morton, Lindsay M; Onel, Kenan; Pierce, John P; Robison, Leslie L; Rowland, Julia H; Schrag, Deborah; Sellers, Thomas A; Seminara, Daniela; Shu, Xiao Ou; Thomas, Nancy E; Ulrich, Cornelia M; Freedman, Andrew N

    2013-01-16

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

  4. Defining the clinical outcome status (COS) in sarcoidosis: results of WASOG Task Force.

    PubMed

    Baughman, R P; Nagai, S; Balter, M; Costabel, U; Drent, M; du Bois, R; Grutters, J C; Judson, M A; Lambiri, I; Lower, E E; Muller-Quernheim, J; Prasse, A; Rizzato, G; Rottoli, P; Spagnolo, P; Teirstein, A

    2011-07-01

    The clinical outcome of sarcoidosis is quite variable. Several scoring systems have been used to assess the level of disease and clinical outcome. The definition of clinical phenotypes has become an important goal as genetic studies have identified distinct genotypes associated with different clinical phenotypes. In addition, treatment strategies have been developed for patients with resolving versus non resolving disease. A task force was established by the World Association of Sarcoidosis and Other Granulomatous diseases (WASOG) to define clinical phenotypes of the disease based on the clinical outcome status (COS). The committee chose to examine patients five years after diagnosis to determine the COS. Several features of the disease were incorporated into the final nine categories of the disease. These included the current or past need for systemic therapy, the resolution of the disease, and current status of the condition. Sarcoidosis patients who were African American or older were likely to have a higher COS, indicating more chronic disease. The COS may be useful in future studies of sarcoidosis.

  5. Chemoradiation Therapy for Potentially Resectable Gastric Cancer: Clinical Outcomes Among Patients Who Do Not Undergo Planned Surgery

    SciTech Connect

    Kim, Michelle M.; Mansfield, Paul F.; Das, Prajnan; Janjan, Nora A.; Badgwell, Brian D.; Phan, Alexandria T.; Delclos, Marc E.; Maru, Dipen; Ajani, Jaffer A.; Crane, Christopher H.; Krishnan, Sunil

    2008-05-01

    Purpose: We retrospectively analyzed treatment outcomes among resectable gastric cancer patients treated preoperatively with chemoradiation therapy (CRT) but rendered ineligible for planned surgery because of clinical deterioration or development of overt metastatic disease. Methods and Materials: Between 1996 and 2004, 39 patients with potentially resectable gastric cancer received preoperative CRT but failed to undergo surgery. At baseline clinical staging, 33 (85%) patients had T3-T4 disease, and 27 (69%) patients had nodal involvement. Most patients received 45 Gy of radiotherapy with concurrent 5-fluorouracil-based chemotherapy. Twenty-one patients underwent induction chemotherapy before CRT. Actuarial times to local control (LC), distant control (DC), and overall survival (OS) were calculated by the Kaplan-Meier method. Results: The cause for surgical ineligibility was development of metastatic disease (28 patients, 72%; predominantly peritoneal, 18 patients), poor performance status (5 patients, 13%), patient/physician preference (4 patients, 10%), and treatment-related death (2 patients, 5%). With a median follow-up of 8 months (range, 1-95 months), actuarial 1-year LC, DC, and OS were 46%, 12%, and 36%, respectively. Median LC and OS were 11.0 and 10.1 months, respectively. Conclusions: Patients with potentially resectable gastric cancer treated with preoperative CRT are found to be ineligible for surgery principally because of peritoneal progression. Patients who are unable to undergo planned surgery have outcomes comparable to that of patients with advanced gastric cancer treated with chemotherapy alone. CRT provides durable LC for the majority of the remaining life of these patients.

  6. Undersized angioplasty and stenting of symptomatic intracranial tight stenosis with Enterprise: Evaluation of clinical and vascular outcome

    PubMed Central

    Lee, Kun-Yu; Chen, David Yen-Ting; Hsu, Hui-Ling; Chen, Chi-Jen

    2015-01-01

    Background Severe intracranial arterial stenosis results in more than 10% incidence of stroke and transient ischemic attack. Using undersized angioplasty with off-label closed-cell Enterprise stent may be a feasible alternative option for treating patients with intracranial atherosclerotic disease who fail dual-antiplatelet medical therapy. The results of the authors’ study are presented in this paper. Materials and methods Between January 2013 and July 2014, 24 symptomatic patients with a total of 30 intracranial arterial stenotic lesions refractory to medical therapy, who underwent undersized angioplasty and Enterprise stenting, were retrospectively reviewed in the authors’ institution. The results evaluated include technical success rate, clinical outcome measured as modified Rankin Scale at presentation and follow-up, peri-procedural morbidity within 30 days and 1 year, and follow-up vessel patency. Results Stent deployment was successfully achieved in all stenotic lesions (30/30). Mean pre-stent and post-stent diameter residual stenosis was 81% and 18%, respectively. The peri-procedural complication rate during 30 days after stenting was 10% per lesion (3/30), including intracranial hemorrhage, in-stent thrombosis and ischemic stroke. No further thromboembolic event or complication occurred in any patient more than 30 days after stenting. Modified Rankin scale ≤ 2 was observed in 64% and 83% of patients at initial presentation and follow-up (mean 15.8 months), respectively. Imaging follow-up was available in 17 of 24 patients (70.8%) and 20 of 30 treated lesions (66.6%) with a mean follow-up period of 15.4 months. Only one asymptomatic in-stent restenosis occurred in 20 available lesions (5.0%). Conclusion This preliminary study suggests that using undersized angioplasty and Enterprise stenting may effectively treat high-degree symptomatic intracranial arterial stenosis with favorable clinical and angiographic outcome. PMID:26542728

  7. 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

  8. Relationship between Helicobacter pylori virulence factors and regulatory cytokines as predictors of clinical outcome

    PubMed Central

    Serrano, Carolina; Diaz, Maria Ines; Valdivia, Alejandra; Godoy, Alex; Peña, Alfredo; Rollan, Antonio; Kirberg, Arturo; Hebel, Eduardo; Fierro, Jaqueline; Klapp, Gerardo; Venegas, Alejandro; Harris, Paul R.

    2013-01-01

    H. pylori infection is highly prevalent in Chile (73%). Usually a minority of infected patients develops complications such as ulcers and gastric cancer that have been associated with the presence of virulence factors (cagA, vacA) and host T helper response (Th1/Th2). Our aim was to evaluate the relationship between strain virulence and host immune response, using a multiple regression approach for the development of a model based on data collected from H. pylori infected patients in Chile. We analyzed levels of selected cytokines determined by ELISA (IL-12, IL-10, IFN-γ and IL-4) and the presence of cagA and vacA alleles polymorphisms determined by PCR in antral biopsies of 41 patients referred to endoscopy. By multiple regression analysis we established a correlation between bacterial and host factors using clinical outcome (gastritis and duodenal ulcer) as dependent variables. The selected model was described by: clinical outcome = 0.867491 (cagA) + 0.0131847 (IL-12/IL-10) + 0.0103503 (IFN-γ/IL-4) and it was able to explain over 90% of clinical outcomes observations (R2=96.4). This model considers that clinical outcomes are better explained by the interaction of host immune factors and strain virulence as a complex and interdependent mechanism. PMID:17336120

  9. Urinary paraben concentrations and in vitro fertilization outcomes among women from a fertility clinic

    PubMed Central

    Mínguez-Alarcón, Lidia; Chiu, Yu-Han; Messerlian, Carmen; Williams, Paige L.; Sabatini, Mary E.; Toth, Thomas L.; Ford, Jennifer B.; Calafat, Antonia M.; Hauser, Russ

    2015-01-01

    Objective To explore the relationship between urinary paraben concentrations and IVF outcomes among women attending an academic fertility center. Design Prospective cohort study. Setting Fertility clinic in a hospital setting. Patient(s) A total of 245 women contributing 356 IVF cycles. Intervention(s) None. Quantification of urinary concentrations of parabens by isotope-dilution tandem mass spectrometry, and assessment of clinical endpoints of IVF treatments abstracted from electronic medical records at the academic fertility center. Main Outcome Measure(s) Total and mature oocyte counts, proportion of high quality embryos, fertilization rates, and rates of implantation, clinical pregnancy and live births. Results The geometric mean of the urinary concentrations of methyl (MP), propyl (PP) and butyl paraben (BP) in our study population were 133, 24 and 1.5 µg/L, respectively. In models adjusted for age, body mass index, race/ethnicity, smoking status and primary infertility diagnosis, urinary MP, PP and BP concentrations were not associated with IVF outcomes, specifically total and mature oocyte counts, proportion of high embryo quality and fertilization rates. Moreover, no significant associations were found between urinary paraben concentrations and rates of implantation, clinical pregnancy and live births. Conclusion(s) Urinary paraben concentrations were not associated with IVF outcomes among women undergoing infertility treatments. PMID:26654974

  10. 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…

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

    PubMed

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

    2008-12-01

    Compared with nonfunded or peer-reviewed funded projects, industry-sponsored clinical trials have traditionally been associated with more positive results. This relationship has been extensively studied in the nonsurgical literature. Although a few authors have addressed specialties, little has been reported on orthopedic clinical trials and their association with funding, study outcome, and efforts to reduce bias after randomization across journals of multiple subspecialties. For the study reported here, we selected 5 major orthopedic subspecialty journals: Journal of Bone and Joint Surgery (American Volume), Spine, Journal of Arthroplasty, Journal of Orthopaedic Trauma, and American Journal of Sports Medicine. We chose a 2-year limit for investigation (2002-2004); included all original randomized clinical trials reported in these 5 journals; and examined these trials for their study design, funding source, outcome, bias potential, and conclusion reached. Support for the 100 eligible orthopedic clinical trials was stated as coming from industry (26 trials, 26%), nonprofit sources (19 trials, 19%), and mixed sources (5 trials, 5%); no support was stated in 46 trials (46%), and support was not reported in 4 trials (4%). Of the 26 trials reporting industry support, 22 (85%) were graded as indicating an outcome favorable to the new treatment. The association between industry funding and favorable outcome was strong and significant (P<.001). In almost half of the studies reported in Journal of Bone and Joint Surgery and Spine, measures taken to reduce bias were not documented.

  12. Socioeconomic inequality in clinical outcome among hip fracture patients: a nationwide cohort study.

    PubMed

    Kristensen, P K; Thillemann, T M; Pedersen, A B; Søballe, K; Johnsen, S P

    2017-04-01

    The evidence is limited regarding the association between socioeconomic status and the clinical outcome among patients with hip fracture. In this nationwide, population-based cohort study, higher education and higher family income were associated with a substantially lower 30-day mortality and risk of unplanned readmission after hip fracture.

  13. 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

  14. Clinical characteristics and treatment outcomes of pulmonary disease caused by Mycobacterium chimaera.

    PubMed

    Moon, Seong Mi; Kim, Su-Young; Jhun, Byung Woo; Lee, Hyun; Park, Hye Yun; Jeon, Kyeongman; Huh, Hee Jae; Ki, Chang-Seok; Lee, Nam Yong; Shin, Sung Jae; Koh, Won-Jung

    2016-12-01

    Mycobacterium chimaera is a recently described species distinct from M. intracellulare. M. chimaera is regarded as less virulent than M. intracellulare. Using multi-locus sequence-based identification, M. chimaera lung disease was diagnosed in 11 patients. Clinical characteristics and outcomes of M. chimaera lung disease were comparable to M. intracellulare lung disease.

  15. Prognostic Factors of Clinical Outcomes in Patients with Spontaneous Thalamic Hemorrhage

    PubMed Central

    Lee, Sang-Hoon; Park, Kyung-Jae; Kang, Shin-Hyuk; Jung, Yong-Gu; Park, Jung-Yul; Park, Dong-Hyuk

    2015-01-01

    Background Intracerebral hemorrhage (ICH) is a well-known condition, but ICH restricted to the thalamus is less widely studied. We investigated the prognostic factors of thalamic ICHs. Material/Methods Seventy patients from January 2009 to November 2014 were retrospectively reviewed. Patients who demonstrated spontaneous ICH primarily affecting the thalamus on initial brain computed tomography (CT) were enrolled. Patients were categorized into 2 groups based on their Glasgow Outcome Scale (GOS) scores. Various presumptive prognostic factors were analyzed to investigate relationships between various clinical characteristics and outcomes. Results Of the enrolled patients, 39 showed a GOS of 4–5, and were categorized as the good outcome group, while another 31 patients showed a GOS of 1–3 and were categorized as the poor outcome group. Initial GCS score, calculated volume of hematoma, presence of intraventricular hemorrhage (IVH), coexisting complications, hydrocephalus, performance of external ventricular drainage, and modified Graeb’s scores of patients with IVH were significantly different between the 2 groups. In multivariate analysis, among the factors above, initial GCS score (P=0.002, Odds ratio [OR]=1.761, Confidence interval [CI]=1.223–2.536) and the existence of systemic complications (P=0.015, OR=0.059, CI=0.006–0.573) were independently associated with clinical outcomes. Calculated hematoma volume showed a borderline relationship with outcomes (P=0.079, OR=0.920, CI=0.839–1.010). Conclusions Initial GCS score and the existence of systemic complications were strong predictive factors for prognosis of thalamic ICH. Calculated hematoma volume also had predictive value for clinical outcomes. PMID:26343784

  16. Factors Associated with Clinical Outcomes in Patients with Primary Intraventricular Hemorrhage

    PubMed Central

    Lee, Sang-Hoon; Park, Kyung-Jae; Park, Dong-Hyuk; Kang, Shin-Hyuk; Park, Jung-Yul; Jung, Yong-Gu

    2017-01-01

    Background Primary intraventricular hemorrhage (PIVH) is an uncommon type of intracerebral hemorrhage. Owing to its rarity, the clinical and radiological factors affecting outcomes in patients with PIVH have not been widely studied. Material/Methods We retrospectively reviewed 112 patients (mean age 53 years) treated for PIVH at our institution from January 2004 to December 2014. Clinical and radiological parameters were analyzed 3 months after initial presentation to identify factors associated with clinical outcomes, as assessed by the Glasgow Outcome Scale (favorable ≥4, unfavorable <4). Results Of the 99 patients who underwent angiography, causative vascular abnormalities were found in 46%, and included Moyamoya disease, arteriovenous malformation, and cerebral aneurysm. At 3 months after initial presentation, 64% and 36% of patients were in the favorable and unfavorable outcome groups, respectively. The mortality rate was 19%. However, most survivors had no or mild deficits. Age, initial Glasgow Coma Scale (GCS) score, simplified acute physiology score (SAPS II), modified Graeb score, and various radiological parameters reflecting ventricular dilatation were significantly different between the groups. Specifically, a GCS score of less than 13 (p=0.015), a SAPS II score of less than 33 (p=0.039), and a dilated fourth ventricle (p=0.043) were demonstrated to be independent predictors of an unfavorable clinical outcome. Conclusions In this study we reveal independent predictors of poor outcome in primary intraventricular hemorrhage patients, and show that nearly half of the patients in our study had predisposing vascular abnormalities. Routine angiography is recommended in the evaluation of PIVH to identify potentially treatable etiologies, which may enhance long-term prognosis. PMID:28325888

  17. 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.

  18. Significance of frailty for predicting adverse clinical outcomes in different patient groups with specific medical conditions.

    PubMed

    Ritt, Martin; Gaßmann, Karl-Günter; Sieber, Cornel Christian

    2016-10-01

    Frailty is a major health burden in an aging society. It constitutes a clinical state of reduced physiological reserves that is associated with a diminished ability to withstand internal and external stressors. Frail patients have an increased risk for adverse clinical outcomes, such as mortality, readmission to hospital, institutionalization and falls. Of further clinical interest, frailty might be at least in part reversible in some patients and subject to preventive strategies. In daily clinical practice older patients with a complex health status, who are mostly frail or at least at risk of developing frailty, are frequently cared for by geriatricians. Recently, clinicians and scientists from other medical disciplines, such as cardiology, pulmonology, gastroenterology, nephrology, endocrinology, rheumatology, surgery and critical care medicine also discovered frailty to be an interesting instrument for risk stratification of patients, including younger patients. In this review we highlight the results of recent studies that demonstrated the significance of frailty to predict adverse clinical outcomes in patients with specific medical conditions, such as cardiac, lung, liver and kidney diseases as well as diabetes mellitus, osteoarthritis, trauma patients, patients undergoing surgery and critically ill patients. Multiple studies in patients with the aforementioned specific medical conditions could be identified demonstrating a predictive role of frailty for several adverse clinical outcomes. The association between frailty and adverse clinical outcomes reported in these studies was in part independent of several major potential confounder factors, such as age, sex, race, comorbidities and disabilities and were also detected in younger patients.

  19. Long-Term Clinical and Radiologic Outcomes of Minimally Invasive Posterior Cervical Foraminotomy

    PubMed Central

    2014-01-01

    Objective To report long-term clinical and radiological outcomes of minimally invasive posterior cervical foraminotomy (MI-PCF) performed in patients with unilateral single-level cervical radiculopathy. Methods Of forty-six patients who underwent MI-PCF for unilateral single-level radiculopathy between 2005 and 2013, 33 patients were included in the study, with a mean follow-up of 32.7 months. Patients were regularly followed for clinical and radiological assessment. Clinical outcome was measured by visual analogue scale (VAS) for the neck/shoulder and arm, and the neck disability index (NDI). Radiological outcome was measured by focal/global angulation and disc height index (DHI). Outcomes after MI-PCF were evaluated as changes of clinical and radiological parameters from the baseline. Mixed effect model with random patients' effect was used to test for differences in the clinical and radiological parameters repeat measures. Results There were no complications and all patients had an uneventful recovery during the early postoperative period. VAS scores for neck/shoulder and arm improved significantly in the early postoperative period (3 months) and were maintained with time (p<0.001). NDI improved significantly post-operatively and tended to decrease gradually during the follow-up period (p<0.001). There were no statistically significant changes in focal and global angulation at follow-up. Percent DHIs of the upper adjacent or operated disc were maintained without significant changes with time. During the follow-up, same site recurrence was not noted and adjacent segment disease requiring additional surgery occurred in two patients (6%) on the contra-lateral side. Conclusion MI-PCF provides long-term pain relief and functional restoration, accompanied by good long-term radiological outcome. PMID:25368765

  20. Colles' fracture treated with non-bridging external fixation: a 1-year follow-up.

    PubMed

    Andersen, J K; Høgh, A; Gantov, J; Vaesel, M T; Hansen, T Baek

    2009-08-01

    The results in 75 of 105 patients with Older type II/III (AO type A2.2, A3.1, A3.2) Colles' fractures, treated with non-bridging external fixation are presented. The mean age was 67.8 years, and all patients were followed prospectively for 12 months with radiological and functional assessment. No statistically significant loss of radial length, angulation or inclination was seen between the postoperative reduction and the 1-year follow-up examination. The clinical results after 1 year were 66 (88%) excellent/good, nine (12%) fair and 0 (0%) poor according to the modified Gartland and Werley score. Mean visual analogue scale pain score after 1 year was 0.8. In three patients (4%), re-displacement of the fracture occurred and was treated with plating. Non-bridging external fixation offers a reliable method of maintaining radiological reduction of Older type II/III fractures of the distal radius and gives a good functional outcome after 1 year.

  1. Medical Students as Health Educators at a Student-Run Free Clinic: Improving the Clinical Outcomes of Diabetic Patients

    PubMed Central

    Peltz, Alon; Ladner, Travis R.; Reddy, India; Miller, Bonnie M.; Miller, Robert F.; Fowler, Michael J.

    2014-01-01

    Purpose Student-run free clinics (SRFCs) provide service–learning opportunities for medical students and care to underserved patients. Few published studies, however, support that they provide high-quality care. In this study, the authors examined the clinical impact of a medical student health educator program for diabetic patients at an SRFC. Method In 2012, the authors retrospectively reviewed the electronic medical records of diabetic patients who established care at Shade Tree Clinic in Nashville, Tennessee, between 2008 and 2011. They compared clinical outcomes at initial presentation to the clinic and 12 months later. They analyzed the relationship between the number of patient–student interactions (touchpoints) and change in hemoglobin A1c values between these two time points and compared the quality of care provided to best-practice benchmarks (process and outcomes measures). Results The authors studied data from 45 patients. Mean hemoglobin A1c values improved significantly from 9.6 to 7.9, after a mean of 12.5 ± 1.5 months (P < .0001). A trend emerged between increased number of touchpoints and improvement in A1c values (r2 = 0.06, P = .10). A high percentage of patients were screened during clinic visits, whereas a low to moderate percentage met benchmarks for A1c, LDL, and blood pressure levels. Conclusions These findings demonstrate that a medical student health educator program at an SRFC can provide high-quality diabetes care and facilitate clinical improvement one year after enrollment, despite inherent difficulties in caring for underserved patients. Future studies should examine the educational and clinical value of care provided at SRFCs. PMID:24556762

  2. 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

  3. Clinical and pathological outcomes after resection of intramedullary spinal cord tumors: a single-institution case series.

    PubMed

    Samuel, Nardin; Tetreault, Lindsay; Santaguida, Carlo; Nater, Anick; Moayeri, Nizar; Massicotte, Eric M; Fehlings, Michael G

    2016-08-01

    OBJECTIVE The objective of this study was to identify clinically relevant predictors of progression-free survival and functional outcomes in patients who underwent surgery for intramedullary spinal cord tumors (ISCTs). METHODS An institutional spinal tumor registry and billing records were reviewed to identify adult patients who underwent resection of ISCTs between 1993 and 2014. Extensive data were collected from patient charts and operative notes, including demographic information, extent of resection, tumor pathology, and functional and oncological outcomes. Survival analysis was used to determine important predictors of progression-free survival. Logistic regression analysis was used to evaluate the association between an "optimal" functional outcome on the Frankel or McCormick scale at 1-year follow-up and various clinical and surgical characteristics. RESULTS The consecutive case series consisted of 63 patients (50.79% female) who underwent resection of ISCTs. The mean age of patients was 41.92 ± 14.36 years (range 17.60-75.40 years). Complete microsurgical resection, defined as no evidence of tumor on initial postoperative imaging, was achieved in 34 cases (54.84%) of the 62 patients for whom this information was available. On univariate analysis, the most significant predictor of progression-free survival was tumor histology (p = 0.0027). Patients with Grade I/II astrocytomas were more likely to have tumor progression than patients with WHO Grade II ependymomas (HR 8.03, 95% CI 2.07-31.11, p = 0.0026) and myxopapillary ependymomas (HR 8.01, 95% CI 1.44-44.34, p = 0.017). Furthermore, patients who underwent radical or subtotal resection were more likely to have tumor progression than those who underwent complete resection (HR 3.46, 95% CI 1.23-9.73, p = 0.018). Multivariate analysis revealed that tumor pathology was the only significant predictor of tumor progression. On univariate analysis, the most significant predictors of an "optimal" outcome on the

  4. 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

  5. Anger Disturbances among Perpetrators of Intimate Partner Violence: Clinical Characteristics and Outcomes of Court-Mandated Treatment

    ERIC Educational Resources Information Center

    Eckhardt, Christopher I.; Samper, Rita E.; Murphy, Christopher M.

    2008-01-01

    In the present study, the authors clustered a pretreatment sample of 190 perpetrators of intimate partner violence (IPV) mandated to attend group counseling based on State-Trait Anger Expression Inventory scores and examined whether these profiles were associated with differential outcomes 1 year postadjudication. Cluster analysis revealed 3…

  6. One-Year Outcomes of a Randomized Clinical Trial Treating Depression in Low-Income Minority Women

    ERIC Educational Resources Information Center

    Miranda, Jeanne; Green, Bonnie L.; Krupnick, Janice L.; Chung, Joyce; Siddique, Juned; Belin, Tom; Revicki, Dennis

    2006-01-01

    This study examines 1-year depressive symptom and functional outcomes of 267 predominantly low-income, young minority women randomly assigned to antidepressant medication, group or individual cognitive-behavioral therapy (CBT), or community referral. Seventy-six percent assigned to medications received 9 or more weeks of guideline-concordant doses…

  7. SPORT: Radiographic Predictors of Clinical Outcomes Following Operative or Non-operative Treatment of Degenerative Spondylolisthesis

    PubMed Central

    Pearson, Adam M.; Lurie, Jon D.; Blood, Emily A.; Frymoyer, John W.; Braeutigam, Heike; An, Howard; Girardi, Federico P.; Weinstein, James N.

    2009-01-01

    STUDY DESIGN Subgroup analyses according to treatment received. OBJECTIVES To evaluate whether baseline radiographic findings predicted outcomes in patients with degenerative spondylolisthesis (DS). SUMMARY OF BACKGROUND DATA The SPORT combined randomized and observational DS cohorts. METHODS The Meyerding listhesis grade was determined on the neutral radiograph (n=222). Patients were classified as having low disk height if disk height was less than 5 mm. Flexion-extension radiographs (n=185) were evaluated for mobility. Those with greater than 10° rotation or 4mm translation were considered Hypermobile. Changes in outcome measures were compared between listhesis (Grade 1 vs. Grade 2), disk height (Low vs. Normal) and mobility (Stable vs. Hypermobile) groups using longitudinal regression models adjusted for potential confounders. Outcome measures included SF-36 bodily pain (BP) and physical function (PF) scales, Oswestry disability index (ODI), stenosis bothersomeness index (SBI), and low back pain bothersomeness scale. RESULTS Overall, 86% had a Grade 1 listhesis, 78% had Normal disk height, and 73% were Stable. Baseline symptom severity was similar between groups. Overall, surgery patients improved more than patients treated non-operatively. At one year, outcomes were similar in surgery patients across listhesis, disk height, and mobility groups (ODI: Grade 1 -23.7 vs. Grade 2 -23.3, p=0.90; Normal disk height-23.5 vs. Low disk height -21.9, p=0.66; Stable -21.6 vs. Hypermobile -25.2, p=0.30). Among those treated nonoperatively, Grade 1 patients improved more than Grade 2 patients (BP +13.1 vs. -4.9, p=0.019; ODI -8.0 vs. +4.8, p=0.010 at 1 year), and Hypermobile patients improved more than Stable patients (ODI -15.2 vs -6.6, p=0.041; SBI -7.8 vs -2.7, p=0.002 at 1 year). DISCUSSION Regardless of listhesis grade, disk height or mobility, patients who had surgery improved more than those treated non-operatively. These differences were due, in part, to differences

  8. Early clinical prediction of neurological outcome following out of hospital cardiac arrest managed with therapeutic hypothermia

    PubMed Central

    Ruknuddeen, Mohammed Ishaq; Ramadoss, Rajaram; Rajajee, V.; Grzeskowiak, Luke E.; Rajagopalan, Ram E.

    2015-01-01

    Background: Therapeutic hypothermia (TH) may improve neurological outcome in comatose patients following out of hospital cardiac arrest (OHCA). The reliability of clinical prediction of neurological outcome following TH remains unclear. In particular, there is very limited data on survival and predictors of neurological outcome following TH for OHCA from resource-constrained settings in general and South Asia in specific. Objective: The objective was to identify factors predicting unfavorable neurological outcome at hospital discharge in comatose survivors of OHCA treated with hypothermia. Design: Retrospective chart review. Setting: Urban 200-bed hospital in Chennai, India. Methods: Predictors of unfavorable neurological outcome (cerebral performance category score [3–5]) at hospital discharge were evaluated among patients admitted between January 2006 and December 2012 following OHCA treated with TH. Hypothermia was induced with cold intravenous saline bolus, ice packs and cold-water spray with bedside fan. Predictors of unfavorable neurological outcome were examined through multivariate exact logistic regression analysis. Results: A total of 121 patients were included with 106/121 (87%) experiencing the unfavorable neurological outcome. Independent predictors of unfavorable neurological outcome included: Status myoclonus <24 h (odds ratio [OR] 21.79, 95% confidence interval [CI] 2.89-Infinite), absent brainstem reflexes (OR 50.09, 6.55-Infinite), and motor response worse than flexion on day 3 (OR 99.41, 12.21-Infinite). All 3 variables had 100% specificity and positive predictive value. Conclusion: Status myoclonus within 24 h, absence of brainstem reflexes and motor response worse than flexion on day 3 reliably predict unfavorable neurological outcome in comatose patients with OHCA treated with TH. PMID:26195855

  9. Cerebral perfusion pressure, microdialysis biochemistry and clinical outcome in patients with traumatic brain injury

    PubMed Central

    2011-01-01

    Background Traumatic Brain Injury (TBI) is a major cause of death and disability. It has been postulated that brain metabolic status, intracranial pressure (ICP) and cerebral perfusion pressure (CPP) are related to patients' outcome. The aim of this study was to investigate the relationship between CPP, ICP and microdialysis parameters and clinical outcome in TBIs. Results Thirty four individuals with severe brain injury hospitalized in an intensive care unit participated in this study. Microdialysis data were collected, along with ICP and CPP values. Glasgow Outcome Scale (GOS) was used to evaluate patient outcome at 6 months after injury. Fifteen patients with a CPP greater than 75 mmHg, L/P ratio lower than 37 and Glycerol concentration lower than 72 mmol/l had an excellent outcome (GOS 4 or 5), as opposed to the remaining 19 patients. No patient with a favorable outcome had a CPP lower than 75 mmHg or Glycerol concentration and L/P ratio greater than 72 mmol/l and 37 respectively. Data regarding L/P ratio and Glycerol concentration were statistically significant at p = 0.05 when patients with favorable and unfavorable outcome were compared. In a logistic regression model adjusted for age, sex and Glasgow Coma Scale on admission, a CPP greater than 75 mmHg was marginally statistically significantly related to outcome at 6 months after injury. Conclusions Patients with favorable outcome had certain common features in terms of microdialysis parameters and CPP values. An individualized approach regarding CPP levels and cut -off points for Glycerol concentration and L/P ratio are proposed. PMID:22168902

  10. Long-Term Clinical Outcomes according to Initial Management and Thrombolysis In Myocardial Infarction Risk Score in Patients with Acute Non-ST-Segment Elevation Myocardial Infarction

    PubMed Central

    Jeong, Hae Chang; Jeong, Myung Ho; Chae, Shung Chull; Hur, Seung Ho; Hong, Taek Jong; Kim, Young Jo; Seong, In Whan; Chae, Jei Keon; Rhew, Jay Young; Chae, In Ho; Cho, Myeong Chan; Bae, Jang Ho; Rha, Seung Woon; Kim, Chong Jin; Choi, Donghoon; Jang, Yang Soo; Yoon, Junghan; Chung, Wook Sung; Cho, Jeong Gwan; Seung, Ki Bae; Park, Seung Jung

    2010-01-01

    Purpose There is still debate about the timing of revascularization in patients with acute non-ST-segment elevation myocardial infarction (NSTEMI). We analyzed the long-term clinical outcomes of the timing of revascularization in patients with acute NSTEMI obtained from the Korea Acute Myocardial Infarction Registry (KAMIR). Materials and Methods 2,845 patients with acute NSTEMI (65.6 ± 12.5 years, 1,836 males) who were enrolled in KAMIR were included in the present study. The therapeutic strategy of NSTEMI was categorized into early invasive (within 48 hours, 65.8 ± 12.6 years, 856 males) and late invasive treatment (65.3 ± 12.1 years, 979 males). The initial- and long-term clinical outcomes were compared between two groups according to the level of Thrombolysis In Myocardial Infarction (TIMI) risk score. Results There were significant differences in-hospital mortality and the incidence of major adverse cardiac events during one-year clinical follow-up between two groups (2.1% vs. 4.8%, p < 0.001, 10.0% vs. 13.5%, p = 0.004, respectively). According to the TIMI risk score, there was no significant difference of long-term clinical outcomes in patients with low to moderate TIMI risk score, but significant difference in patients with high TIMI risk score (≥ 5 points). Conclusions The old age, high Killip class, low ejection fraction, high TIMI risk score, and late invasive treatment strategy are the independent predictors for the long-term clinical outcomes in patients with NSTEMI. PMID:20046515

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

    PubMed Central

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

    2017-01-01

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

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

    PubMed

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

    2017-01-01

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

  13. 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

  14. Correlation between classification in risk categories and clinical aspects and outcomes 1

    PubMed Central

    Oliveira, Gabriella Novelli; Vancini-Campanharo, Cássia Regina; Lopes, Maria Carolina Barbosa Teixeira; Barbosa, Dulce Aparecida; Okuno, Meiry Fernanda Pinto; Batista, Ruth Ester Assayag

    2016-01-01

    ABSTRACT Objective: to correlate classification in risk categories with the clinical profiles, outcomes and origins of patients. Method: analytical cross-sectional study conducted with 697 medical forms of adult patients. The variables included: age, sex, origin, signs and symptoms, exams, personal antecedents, classification in risk categories, medical specialties, and outcome. The Chi-square and likelihood ratio tests were used to associate classifications in risk categories with origin, signs and symptoms, exams, personal antecedents, medical specialty, and outcome. Results: most patients were women with an average age of 44.5 years. Pain and dyspnea were the symptoms most frequently reported while hypertension and diabetes mellitus were the most common comorbidities. Classifications in the green and yellow categories were the most frequent and hospital discharge the most common outcome. Patients classified in the red category presented the highest percentage of ambulance origin due to surgical reasons. Those classified in the orange and red categories also presented the highest percentage of hospitalization and death. Conclusion: correlation between clinical aspects and outcomes indicate there is a relationship between the complexity of components in the categories with greater severity, evidenced by the highest percentage of hospitalization and death. PMID:27982310

  15. 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.

  16. 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

  17. Low socioeconomic status, adverse gene expression profiles, and clinical outcomes in hematopoietic stem cell transplant recipients

    PubMed Central

    Knight, Jennifer M.; Rizzo, J. Douglas; Logan, Brent R.; Wang, Tao; Arevalo, Jesusa M.G.; Ma, Jeffrey; Cole, Steve W.

    2015-01-01

    Purpose Low socioeconomic status (SES) is associated with adverse outcomes among unrelated donor hematopoietic stem cell transplant (HCT) recipients, but the biological mechanisms contributing to this health disparity are poorly understood. Therefore, we examined whether social environment affects expression of a stress-related gene expression profile known as the conserved transcriptional response to adversity (CTRA), which involves up-regulation of pro-inflammatory genes and down-regulation of genes involved in type I IFN response and antibody synthesis. Experimental Design We compared pre-transplant leukocyte CTRA gene expression between a group of 78 high vs. low SES recipients of unrelated donor HCT for acute myelogenous leukemia in first remission. Post hoc exploratory analyses also evaluated whether CTRA gene expression was associated with poor clinical outcomes. Results Peripheral blood mononuclear cells collected pre-HCT from low SES individuals demonstrated significant CTRA up-regulation compared to matched HCT recipients of high SES. Promoter-based bioinformatics implicated distinct patterns of transcription factor activity including increased CREB signaling and decreased IRF and GR signaling. High expression of the CTRA gene profile was also associated with increased relapse risk and decreased leukemia-free survival. Conclusions Low SES is associated with increased expression of the CTRA gene profile, and CTRA gene expression is associated with adverse HCT clinical outcomes. These findings provide a biologic framework within which to understand how social environmental conditions may influence immune function and clinical outcomes in allogeneic HCT. PMID:26286914

  18. Spinal cord infarction: clinical and magnetic resonance imaging findings and short term outcome

    PubMed Central

    Masson, C; Pruvo, J; Meder, J; Cordonnier, C; Touze, E; de la Sayette, V; Giroud, M; Mas, J; Leys, D

    2004-01-01

    Background: Most studies on spinal cord infarction have been conducted in single centres; they usually consisted of case reports, or of larger series of patients recruited over a large period of time, with heterogeneous diagnostic procedures. Therefore, the clinical and radiological presentation of spinal cord infarcts and their short term outcome remain poorly understood. Objective: To define clinical and magnetic resonance imaging (MRI) findings, and short term outcome in patients with spinal cord infarcts. Methods: The authors prospectively included patients within 10 days of onset. An MRI scan was required and repeated when initially normal. Results: Twenty eight consecutive patients were included over a 24 month period in 16 neurological centres. The infarct was cervical in seven patients, thoracic in three, thoracolumbar in 15, and restricted to the conus in three. On axial MRI scans the infarct was located in the central territory of the anterior spinal artery in 21 patients, and in the peripheral arterial territory in three. At month two, 15 patients had a good outcome and 13 had a poor outcome, including three deaths. Patients who, at onset, could not walk, had bladder dysfunction, or proprioceptive deficits were more likely to have a poor outcome. At month two, pain had occurred in 10 of the 25 survivors and was associated neither with the initial severity, nor the extent of the infarct on MRI. Conclusion: The two month outcome mainly depends on the initial severity of the neurological deficit; however, a few patients with a severe impairment at onset had a good outcome, especially when proprioception remained normal at onset. The study does not support the hypothesis that pain occurs more frequently in small spinal infarcts. PMID:15377691

  19. Detection of enterovirus 68 in serum from pediatric patients with pneumonia and their clinical outcomes.

    PubMed

    Imamura, Tadatsugu; Suzuki, Akira; Lupisan, Socorro; Kamigaki, Taro; Okamoto, Michiko; Roy, Chandra Nath; Olveda, Remigio; Oshitani, Hitoshi

    2014-01-01

    Enterovirus 68 (EV68) infection occasionally manifests with fatal outcomes. However, detection of EV68 in serum and its clinical outcomes are yet to be determined. In this study, we retrospectively tested stored serum samples collected from pediatric pneumonia patients whose nasopharyngeal specimens were positive for EV68. Of total 28 nasopharyngeal sample-positive patients, EV68 was detected in serum samples among 12 (43%) patients aged between 1 and 4 years. Our results suggest that EV68 can cause viremia by which the virus may exhibit systemic manifestations.

  20. Improving clinical outcomes in psychiatric care with touch-screen technology.

    PubMed

    Newnham, Elizabeth A; Doyle, Emma L; Sng, Adelln A H; Hooke, Geoffrey R; Page, Andrew C

    2012-05-01

    Patient-focused research, which uses clinical characteristics to predict outcomes, is a field in which information technology has been effectively integrated with practice. The present research used touch-screen technology to monitor the daily self-report measures of 1,308 consecutive inpatients and day patients participating in a 2-week cognitive-behavioral therapy group. Providing regular feedback was effective in reducing symptoms for patients at risk of poor outcomes (Newnham, Hooke, & Page, 2010b). The use of touch screens in psychiatric monitoring encourages a collaborative dialogue between patients and therapists and promotes engagement in the process of progress monitoring and treatment evaluation.

  1. Perceived Benefits of Pre-Clinical Simulation-based Training on Clinical Learning Outcomes among Omani Undergraduate Nursing Students

    PubMed Central

    Madhavanprabhakaran, Girija; Al-Khasawneh, Esra; Wittmann, Lani

    2015-01-01

    Objectives: This study aimed to explore the benefits perceived by Omani undergraduate maternity nursing students regarding the effect of pre-clinical simulation-based training (PSBT) on clinical learning outcomes. Methods: This non-experimental quantitative survey was conducted between August and December 2012 among third-year baccalaureate nursing students at Sultan Qaboos University in Muscat, Oman. Voluntary participants were exposed to faculty-guided PSBT sessions using low- and medium-fidelity manikins, standardised scenarios and skill checklists on antenatal, intranatal, postnatal and newborn care and assessment. Participants answered a purposely designed self-administered questionnaire on the benefits of PSBT in enhancing learning outcomes. Items were categorised into six subscales: knowledge, skills, patient safety, academic safety, confidence and satisfaction. Scores were rated on a four-point Likert scale. Results: Of the 57 participants, the majority (95.2%) agreed that PSBT enhanced their knowledge. Most students (94.3%) felt that their patient safety practices improved and 86.5% rated PSBT as beneficial for enhancing skill competencies. All male students and 97% of the female students agreed that PSBT enhanced their confidence in the safe holding of newborns. Moreover, 93% of participants were satisfied with PSBT. Conclusion: Omani undergraduate nursing students perceived that PSBT enhanced their knowledge, skills, patient safety practices and confidence levels in providing maternity care. These findings support the use of simulation training as a strategy to facilitate clinical learning outcomes in future nursing courses in Oman, although further research is needed to explore the objective impact of PSBT on learning outcomes. PMID:25685368

  2. Anxiety Sensitivity and Panic Attacks: A 1-Year Longitudinal Study

    ERIC Educational Resources Information Center

    Li, Wen; Zinbarg, Richard E.

    2007-01-01

    The hypothesis that anxiety sensitivity (AS) is a risk factor for panic genesis has obtained compelling support, but the clinical/practical importance of AS in panic genesis has been questioned. In addition, the association between panic experience and AS increase has not been clearly demonstrated. Through this 1-year longitudinal study among…

  3. RD3 loss dictates high-risk aggressive neuroblastoma and poor clinical outcomes.

    PubMed

    Khan, Faizan H; Pandian, Vijayabaskar; Ramraj, Satish Kumar; Aravindan, Sheeja; Natarajan, Mohan; Azadi, Seifollah; Herman, Terence S; Aravindan, Natarajan

    2015-11-03

    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.

  4. 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

  5. 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

  6. Clinical outcome measures for trials in Duchenne muscular dystrophy: report from International Working Group meetings

    PubMed Central

    Bushby, Kate; Connor, Edward

    2012-01-01

    In June 2010, 25 representatives from Europe and the US met in Washington, DC, USA, to discuss clinical outcome measures in Duchenne muscular dystrophy (DMD) in the context of clinical trial design and analysis. The workshop was organized in response to a September 2009 European Medicines Agency meeting where a clear directive was given that an international consensus needs to be developed that provides a foundation for age-appropriate clinical outcome measures for use in clinical trials of emerging therapeutics for DMD. Data were presented from eight multicenter longitudinal datasets, representing nearly 1900 patients over a 20-year time period. This experience confirmed the feasibility of repeated evaluations performed at multiple sites and addressed several core issues in drug development for DMD, such as the ‘new’ natural history in the steroidera, reliability and sensitivity of specific outcome measures, as well as disease staging and patient selection. These data form a valuable asset for academic investigators, pharmaceutical sponsors and regulatory agencies involved in DMD therapeutics. The group remains committed working together on a number of collaborative goals to support the therapeutics development effort in this orphan disease and to make these data available to stakeholders working in the field. PMID:22639722

  7. The effect of a clinical medical librarian on in-patient care outcomes*

    PubMed Central

    Esparza, Julia M.; Shi, Runhua; McLarty, Jerry; Comegys, Marianne; Banks, Daniel E.

    2013-01-01

    Objective: The research sought to determine the effect of a clinical medical librarian (CML) on outcomes of in-patients on the internal medicine service. Methods: A prospective study was performed with two internal medicine in-patient teams. Team 1 included a CML who accompanied the team on daily rounds. The CML answered questions posed at the point of care immediately or in emails post-rounds. Patients on Team 2, which did not include a CML, as well as patients who did not require consultation by the CML on Team 1, served as the control population. Numerous clinical and library metrics were gathered on each question. Results: Patients on Team 1 who required an answer to a clinical question were more ill and had a longer length of stay, higher costs, and higher readmission rates compared to those in the control group. Using a matched pair analysis, we showed no difference in clinical outcomes between the intervention group and the control group. Conclusions: This study is the largest attempt to prospectively measure changes in patient outcomes when physicians were accompanied by a CML on rounds. This approach may serve as a model for further studies to define when and how CMLs are most effective. PMID:23930088

  8. 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.

  9. Comparison of Statistical and Clinical Predictions of Functional Outcome after Ischemic Stroke

    PubMed Central

    Thompson, Douglas D.; Murray, Gordon D.; Sudlow, Cathie L. M.; Dennis, Martin; Whiteley, William N.

    2014-01-01

    Background To determine whether the predictions of functional outcome after ischemic stroke made at the bedside using a doctor’s clinical experience were more or less accurate than the predictions made by clinical prediction models (CPMs). Methods and Findings A prospective cohort study of nine hundred and thirty one ischemic stroke patients recruited consecutively at the outpatient, inpatient and emergency departments of the Western General Hospital, Edinburgh between 2002 and 2005. Doctors made informal predictions of six month functional outcome on the Oxford Handicap Scale (OHS). Patients were followed up at six months with a validated postal questionnaire. For each patient we calculated the absolute predicted risk of death or dependence (OHS≥3) using five previously described CPMs. The specificity of a doctor’s informal predictions of OHS≥3 at six months was good 0.96 (95% CI: 0.94 to 0.97) and similar to CPMs (range 0.94 to 0.96); however the sensitivity of both informal clinical predictions 0.44 (95% CI: 0.39 to 0.49) and clinical prediction models (range 0.38 to 0.45) was poor. The prediction of the level of disability after stroke was similar for informal clinical predictions (ordinal c-statistic 0.74 with 95% CI 0.72 to 0.76) and CPMs (range 0.69 to 0.75). No patient or clinician characteristic affected the accuracy of informal predictions, though predictions were more accurate in outpatients. Conclusions CPMs are at least as good as informal clinical predictions in discriminating between good and bad functional outcome after ischemic stroke. The place of these models in clinical practice has yet to be determined. PMID:25299053

  10. 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

  11. Clinical outcomes of stereotactic body radiotherapy for spinal metastases from hepatocellular carcinoma

    PubMed Central

    Lee, Eonju; Kim, Tae Gyu; Yu, Jeong Il; Lim, Do Hoon; Nam, Heerim; Lee, Hyebin; Lee, Joon Hyeok

    2015-01-01

    Purpose To investigate the outcomes of patients with spinal metastases from hepatocellular carcinoma (HCC), who were treated by stereotactic body radiotherapy (SBRT). Materials and Methods This retrospective study evaluated 23 patients who underwent SBRT from October 2008 to August 2012 for 36 spinal metastases from HCC. SBRT consisted of approximately 2 fractionation schedules, which were 18 to 40 Gy in 1 to 4 fractions for group A lesions (n = 15) and 50 Gy in 10 fractions for group B lesions (n = 21). Results The median follow-up period was 7 months (range, 2 to 16 months). Seven patients developed grade 1 or 2 gastrointestinal toxicity, and one developed grade 2 leucopenia. Compression fractures occurred in association with 25% of the lesions, with a median time to fracture of 2 months. Pain relief occurred in 92.3% and 68.4% of group A and B lesions, respectively. Radiologic response (complete and partial response) occurred in 80.0% and 61.9% of group A and B lesions, respectively. The estimated 1-year spinal-tumor progression-free survival rate was 78.5%. The median overall survival period and 1-year overall survival rate were 9 months (range, 2 to 16 months) and 25.7%, respectively. Conclusion SBRT for spinal metastases from HCC is well tolerated and effective at providing pain relief and radiologic response. Because compression fractures develop at a high rate following SBRT for spinal metastases from primary HCC, careful follow up of the patient is required. PMID:26484305

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

    PubMed Central

    Sveréus, Sofia; Larsson, Kjell; Rehnberg, Clas

    2017-01-01

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

  13. Outcomes of HIV-infected patients receiving care at multiple clinics.

    PubMed

    Yehia, Baligh R; Schranz, Asher J; Momplaisir, Florence; Keller, Sara C; Gross, Robert; Frank, Ian; Metlay, Joshua P; Brady, Kathleen A

    2014-08-01

    Receiving care at multiple clinics may compromise the therapeutic patient-provider alliance and adversely affect the treatment of people living with HIV. We evaluated 12,759 HIV-infected adults in Philadelphia, PA between 2008 and 2010 to determine the effects of using multiple clinics for primary HIV care. Using generalized estimating equations with logistic regression, we examined the relationship between receiving care at multiple clinics (≥ 1 visit to two or more clinics during a calendar year) and two outcomes: (1) use of ART and (2) HIV viral load ≤ 200 copies/mL for patients on ART. Overall, 986 patients (8 %) received care at multiple clinics. The likelihood of attending multiple clinics was greater for younger patients, women, blacks, persons with public insurance, and for individuals in their first year of care. Adjusting for sociodemographic factors, patients receiving care at multiple clinics were less likely to use ART (AOR = 0.62, 95 % CI 0.55-0.71) and achieve HIV viral suppression (AOR = 0.78, 95 % CI 0.66-0.94) than individuals using one clinic. Qualitative data are needed to understand the reasons for visiting multiple clinics.

  14. The Breathe-Easy Home: The Impact of Asthma-Friendly Home Construction on Clinical Outcomes and Trigger Exposure

    PubMed Central

    Krieger, James; Song, Lin; Sharify, Denise; Beaudet, Nancy

    2011-01-01

    Objectives. We examined the asthma-control benefit of moving into an asthma-friendly Breathe-Easy home (BEH). Methods. We used a quasi-experimental design to compare the asthma outcomes of 2 groups of low-income children and adolescents with asthma: 34 participants who moved into a BEH, and a local matched cohort of 68 participants who had received a previous asthma-control intervention. Both groups received in-home asthma education. BEHs were constructed with moisture-reduction features, enhanced ventilation systems, and materials that minimized dust and off-gassing. Results. BEH residents’ asthma-symptom–free days increased from a mean of 8.6 per 2 weeks in their old home to 12.4 after 1 year in the BEH. The proportion of BEH residents with an urgent asthma-related clinical visit in the previous 3 months decreased from 62% to 21%. BEH caretakers’ quality of life increased significantly. The BEH group improved more than did the comparison group, but most differences in improvements were not significant. Exposures to mold, rodents, and moisture were reduced significantly in BEHs. Conclusions. Children and adolescents with asthma who moved into an asthma-friendly home experienced large decreases in asthma morbidity and trigger exposure. PMID:21148715

  15. 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

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

    PubMed

    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.

  17. Monitoring the clinical outcomes in advanced prostate cancer: what imaging modalities and other markers are reliable?

    PubMed

    Morris, Michael J; Autio, Karen A; Basch, Ethan M; Danila, Daniel C; Larson, Steven; Scher, Howard I

    2013-06-01

    Effective patient care and efficient drug development require accurate tools to assess treatment effects. For metastatic castration-resistant prostate cancer (mCRPC), response biomarkers have historically been poorly reproducible, inaccurate, inconsistently applied, or only loosely associated with tangible clinical benefits such as survival. However, the field of response assessments for prostate cancer is maturing, in compliance with a rigorous process defined by analytic validation, clinical validation, and clinical qualification. For example, bone imaging with technetium-99m scintigraphy has historically been poorly used in prostate cancer clinical trials and routine patient care, and frequently has led to poor decision-making. However, contemporary clinical trial consensus criteria (Prostate Cancer Working Group 2 [PCWG2]) have standardized the definition of progression on bone scintigraphy and the clinical trials endpoint of radiographic progression-free survival (rPFS). A validated bone scan interpretation form captures the relevant data elements. rPFS and the forms have been undergoing prospective testing in multiple phase III studies. The first of these trials demonstrated a high degree of reproducibility and correlation with overall survival, and rPFS was used by the US Food and Drug Administration (FDA) for approval of abiraterone in chemotherapy-naïve mCRPC. Circulating tumor cells (CTC) are another class of assays with significant promise as response-indicator biomarkers. CTC enumeration has undergone analytic validation and has been FDA-cleared for monitoring patients with prostate cancer in conjunction with other clinical methods. It is not yet a surrogate for survival. Patient-reported outcomes (PROs) are direct indicators of patient benefit. The assays to measure PROs must undergo each of the steps of biomarker development, and are increasingly being standardized and used as clinical trial endpoints. In this review, we critically assess each of

  18. Severe traumatic brain injury management and clinical outcome using the Lund concept.

    PubMed

    Koskinen, L-O D; Olivecrona, M; Grände, P O

    2014-12-26

    This review covers the main principles of the Lund concept for treatment of severe traumatic brain injury. This is followed by a description of results of clinical studies in which this therapy or a modified version of the therapy has been used. Unlike other guidelines, which are based on meta-analytical approaches, important components of the Lund concept are based on physiological mechanisms for regulation of brain volume and brain perfusion and to reduce transcapillary plasma leakage and the need for plasma volume expanders. There have been nine non-randomized and two randomized outcome studies with the Lund concept or modified versions of the concept. The non-randomized studies indicated that the Lund concept is beneficial for outcome. The two randomized studies were small but showed better outcome in the groups of patients treated according to the modified principles of the Lund concept than in the groups given a more conventional treatment.

  19. Clinical and functional outcomes in people with schizophrenia with a high sense of well-being.

    PubMed

    Fervaha, Gagan; Agid, Ofer; Takeuchi, Hiroyoshi; Foussias, George; Lee, Jimmy; Remington, Gary

    2015-03-01

    Optimal outcome in schizophrenia is thought to include remission of symptoms, functional recovery, and improved subjective well-being. The present study examined the characteristics of individuals with schizophrenia who report being satisfied with their life in general. Individuals with schizophrenia who participated in the Clinical Antipsychotic Trial of Intervention Effectiveness study were included in the present analysis. Approximately half of the individuals evaluated reported a high level of life satisfaction, even while many concurrently described themselves as at least moderately ill and experiencing moderate-severe symptoms and manifested severe functional deficits. Of all individuals evaluated, only about 1% experienced what was considered to be optimal outcome. Individuals with schizophrenia are able to experience a high level of life satisfaction, despite experiencing severe illness and functional deficits. Those involved in care should be aware that life satisfaction as an outcome is not necessarily associated with symptom remission and superior functioning.

  20. 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

  1. Biomechanics of the ankle joint and clinical outcomes of total ankle replacement.

    PubMed

    Michael, Junitha M; Golshani, Ashkahn; Gargac, Shawn; Goswami, Tarun

    2008-10-01

    Until the 1970s ankle arthrodesis was considered to be the "gold-standard" to treat arthritis. But the low fusion rate of ankle arthrodeses along with the inability to achieve normal range of motion led to the growing interest in the development of total ankle replacements. Though the short-term outcomes were good, their long-term outcomes were not as promising. To date, most models do not exactly mimic the anatomical functionality of a natural ankle joint. Therefore, research is being conducted worldwide to either enhance the existing models or develop new models while understanding the intricacies of the joint more precisely. This paper reviews the anatomical and biomechanical aspects of the ankle joint. Also, the evolution and comparison of clinical outcomes of various total ankle replacements are presented.

  2. Can Grafts Provide Superior Tendon Healing and Clinical Outcomes After Rotator Cuff Repairs?

    PubMed Central

    Ono, Yohei; Dávalos Herrera, Diego Alejandro; Woodmass, Jarret M.; Boorman, Richard S.; Thornton, Gail M.; Lo, Ian K. Y.

    2016-01-01

    Background: Arthroscopic repair of large to massive rotator cuff tears commonly retear. To improve healing rates, a number of different approaches have been utilized, including the use of grafts, which may enhance the biomechanical and biologic aspects of the repair construct. However, the outcomes after the use of grafts are diverse. Purpose: To systematically review the literature for large to massive rotator cuff tears to determine whether the use of grafts generally provides superior tendon healing and clinical outcomes to the repairs without grafts. Study Design: Systematic review; Level of evidence, 3. Methods: A systematic review of the literature was performed. Clinical studies comparing the repairs with (graft group) and without grafts (control group) were included and analyzed. The primary outcome was tendon healing on either magnetic resonance imaging or ultrasound. The secondary outcome measures included visual analog scale for pain, University of California at Los Angles (UCLA) score, and forward elevation range. Differences between groups in all outcome measures were statistically analyzed. Results: Six comparative studies (level of evidence 2 or 3) with 13 study groups were included. A total of 242 repairs in the graft group (mean age, 62.5 ± 4.6 years) and 185 repairs in the control group (mean age, 62.5 ± 5.0 years) were analyzed. The graft types utilized included autograft (fascia lata) in 1 study, allograft (human dermis) in 2 studies, xenograft (bovine pericardium, porcine small intestine submucosa) in 2 studies, synthetic graft (polypropylene) in 1 study, and a combination of autograft (the long head of biceps) and synthetic graft (polypropylene) in 1 study. The overall mean follow-up time was 28.4 ± 9.0 months. When 1 or 2 studies/study groups were excluded due to practical or statistical reasons, the graft group demonstrated significantly improved healing (odds ratio, 2.48; 95% CI, 1.58-3.90; P < .0001) and all clinical outcome measures at

  3. Current Clinical Trials in Dry AMD and the Definition of Appropriate Clinical Outcome Measures.

    PubMed

    Yehoshua, Zohar; Rosenfeld, Philip J; Albini, Thomas A

    2011-05-01

    Currently, there is no proven drug treatment for dry age-related macular degeneration (AMD). Several different treatment strategies are being investigated, including complement inhibition, neuroprotection, and visual cycle inhibitors, and novel clinical trial endpoints are being explored. Studies have identified genetic predispositions for dry AMD associated with complement dysfunction. Consequently, complement-based therapeutic treatment modalities are promising.

  4. 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…

  5. 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

  6. Can the fall in serum FSH during coasting in IVF/ICSI predict clinical outcomes?

    PubMed

    Datta, Adrija Kumar; Zosmer, Ariel; Tozer, Amanda; Sabatini, Luca; Davis, Colin; Al-Shawaf, Talha

    2012-05-01

    This retrospective cohort study determined whether the total falls in serum FSH and oestradiol concentrations from start to end of coasting in IVF/intracytoplasmic sperm injection could predict clinical outcomes. Ninety-nine cycles, with gonadotrophin-releasing hormone-agonist down-regulation where coasting with serial serum oestradiol and FSH monitoring was adopted due to risk of severe ovarian hyperstimulation syndrome, were consecutively included. The primary clinical outcome was live-birth rate (LBR); other outcomes measured were number of oocytes retrieved and fertilization, implantation and clinical pregnancy rates. LBR for FSH fall>10 IU/l compared with 5-10 and<5 IU/l were 45.4% versus 22.0% and 25.0%, respectively. Mean serum FSH fall was similar with and without live birth (8.4 ± 6.2 versus 7.3 ± 5.0 IU/l) as were mean oestradiol and FSH concentrations on HCG administration, oestradiol fall, percentage fall in FSH/oestradiol and duration of coasting. None of the variables efficiently predicted live birth on regression analysis. The AUC of FSH fall was 0.53 at 11.0 IU/l. Basal FSH, starting and total gonadotrophin dose and duration of coasting were positively correlated with FSH fall. A potentially clinically important association between live birth and FSH fall during coasting was apparent, which requires further evaluation. The purpose of this retrospective cohort study was to determine whether the magnitude of fall in the serum FSH and oestradiol concentrations from start to end of coasting in IVF/intracytoplasmic sperm injection cycles could predict the clinical outcomes. Gonadotrophin-releasing hormone-agonist down-regulated cycles (n=99), where coasting with serial serum oestradiol and FSH monitoring was adopted due to risk of ovarian hyperstimulation, were consecutively included. Live birth was the primary clinical outcome measured; number of oocytes retrieved and fertilization, implantation and clinical pregnancy rates were the other outcomes

  7. 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

  8. 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.

  9. Associations between the schizophrenia susceptibility gene ZNF804A and clinical outcomes in psychosis

    PubMed Central

    Wickramasinghe, A; Tulloch, A D; Hayes, R D; Chang, C-K; Broadbent, M; Di Forti, M; Murray, R M; Iyegbe, C; Stewart, R

    2015-01-01

    We sought to test the hypothesis that the rs1344706 A allele will be associated with worse clinical outcome in first-episode psychosis. A data linkage was set up between a large systematic study of first-episode psychosis and an electronic health-record case register at the South London and Maudsley NHS Foundation Trust—a large provider of secondary mental-health care. A sample of 291 patients, who presented with a first psychotic episode (ICD10 diagnoses F20–29 or F30–33) and in whom the rs1344706 genotype had been assayed, were followed to examine the duration of mental-health in-patient care during the 2 years following first service contact, as a primary outcome. Secondary outcome measures were whether or not an in-patient episode occurred and the number of in-patient episodes during this period. A strong association was found between the number of rs1344706 A alleles and the cumulative duration of mental-health in-patient stay over the 2 years since initial presentation. In the 84.2% who experienced an in-patient episode during this period, the mean duration of admission was an additional 38 days for each A allele increment. Therefore, in addition to its potential role as a risk factor for psychosis, the ZNF804A rs1344706 A allele is associated with worse clinical outcome. PMID:26670283

  10. Clinical features and pregnancy outcome in antiphospholipid syndrome patients with history of severe pregnancy complications.

    PubMed

    Matsuki, Yuko; Atsumi, Tatsuya; Yamaguchi, Koushi; Hisano, Michi; Arata, Naoko; Oku, Kenji; Watanabe, Noriyoshi; Sago, Haruhiko; Takasaki, Yoshinari; Murashima, Atsuko

    2015-03-01

    Abstract Objective. To clarify the clinical significance of antiphospholipid antibody (aPL) profile in patients with obstetric antiphospholipid syndrome (APS). Methods. Clinical records of 13 pregnant patients (15 pregnancies) with obstetrical APS were reviewed over 10 years. Patients who met the Sapporo Criteria fully were studied, whereas those with only early pregnancy loss were excluded. In addition to classical aPL: lupus anticoagulant (LA), anticardiolipin antibody (aCL), and anti-β2-glycoprotein I (aβ2GPI); phosphatidylserine-dependent anti-prothrombin antibody (aPS/PT) and kininogen-dependent anti-phosphatidylethanolamine antibody (aPE) were also examined in each case. Results. Cases were divided into two groups according to patient response to standard treatment: good and poor outcome groups. All cases with poor outcome presented LA, with IgG aβ2GPI and IgG aPS/PT were also frequently observed. IgG aPE did not correlate with pregnancy outcome. Conclusion. aPL profile may predict pregnancy outcome in patients with this subset of obstetric APS.

  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. 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

  13. 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

  14. 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

  15. Achieving quality and fiscal outcomes in patient care: the clinical mentor care delivery model.

    PubMed

    Burritt, Joan E; Wallace, Patricia; Steckel, Cynthia; Hunter, Anita

    2007-12-01

    Contemporary patient care requires sophisticated clinical judgment and reasoning in all nurses. However, the level of development regarding these abilities varies within a staff. Traditional care models lack the structure and process to close the expertise gap creating potential patient safety risks. In an innovative model, senior, experienced nurses were relieved of direct patient care assignments to oversee nursing care delivery. Evaluation of the model showed significant impact on quality and fiscal outcomes.

  16. The role of glutamine in intensive care unit patients: mechanisms of action and clinical outcome.

    PubMed

    Coëffier, Moïse; Déchelotte, Pierre

    2005-02-01

    Patients in the intensive care unit are at high risk of glutamine depletion and subsequent complications. Several controlled studies and a meta-analysis have concluded that glutamine supplementation has beneficial effects on the clinical outcome of critically ill and surgical patients. These results may be explained by glutamine's influences on the inflammatory response, oxidative stress, cell protection, and the gut barrier. In addition, glutamine may also improve glucose metabolism by reducing insulin resistance.

  17. 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

  18. Predictive value of XPG rs2296147T>C polymorphism on clinical outcomes of cancer patients

    PubMed Central

    Wang, Yuhan; Han, Yingying; Weng, Qiang; Yuan, Zhengrong

    2016-01-01

    The Xeroderma pigmentosum complementation group G (XPG) rs2296147T>C polymorphism is suspected to associate with the clinical outcomes of cancer patients. However, the results are inconsistent. This meta-analysis aimed to evaluate the reliable predictive value of XPG rs2296147T>C polymorphism on clinical outcomes of cancer patients. A total of 11 eligible studies were enrolled in this meta-analysis. Our results indicated that the cancer patients with TT and CT genotypes were significantly associated with better respond rates when compared with the CC genotype (TT versus (vs.) CC: odds ratio (OR) = 2.05, 95% confidence intervals (CIs), 1.32-3.20, P = 0.002; TT+CT vs. CC: OR= 1.57, 95% CI, 1.14-2.17, P = 0.005). The TT genotype and/or T allele might be associated with higher survival time for cancer patients than the CC genotype and/or C allele. The cumulative meta-analyses showed an apparent beneficial objective response of TT genotype on cancer patients. In conclusion, this meta-analysis suggests that the XPG rs2296147T>C polymorphism is associated with the clinical outcomes of cancer patients. The XPG rs2296147T>C polymorphism might be a predictive factor of prognosis in cancers patients and contribute to individual treatment in the future. PMID:27588464

  19. Clinical Features, Etiology, and Outcomes of Community-Acquired Pneumonia in Patients With Diabetes Mellitus

    PubMed Central

    Di Yacovo, Silvana; Garcia-Vidal, Carolina; Viasus, Diego; Adamuz, Jordi; Oriol, Isabel; Gili, Francesca; Vilarrasa, Núria; García-Somoza, M. Dolors; Dorca, Jordi; Carratalà, Jordi

    2013-01-01

    Abstract We performed an observational analysis of a prospective cohort of immunocompetent hospitalized adults with community-acquired pneumonia (CAP) to determine the epidemiology, clinical features, and outcomes of pneumonia in patients with diabetes mellitus (DM). We also analyzed the risk factors for mortality and the impact of statins and other cardiovascular drugs on outcomes. Of 2407 CAP episodes, 516 (21.4%) occurred in patients with DM; 483 (97%) had type 2 diabetes, 197 (40%) were on insulin treatment, and 119 (23.9%) had end-organ damage related to DM. Patients with DM had different clinical features compared to the other patients. They were less likely to have acute onset, cough, purulent sputum, and pleural chest pain. No differences in etiology were found between study groups. Patients with DM had more inhospital acute metabolic complications, although the case-fatality rate was similar between the groups. Independent risk factors for mortality in patients with DM were advanced age, bacteremia, septic shock, and gram-negative pneumonia. Patients with end-organ damage related to DM had more inhospital cardiac events and a higher early case-fatality rate than did the overall population. The use of statins and other cardiovascular drugs was not associated with better CAP outcomes in patients with DM. In conclusion, CAP in patients with DM presents different clinical features compared to the features of patients without DM. PMID:23263718

  20. Clinical Outcomes of Splenectomy in Children: Report of the Splenectomy in Congenital Hemolytic Anemia (SICHA) Registry

    PubMed Central

    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

    2014-01-01

    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 2005–2013 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 gm/dl, 52 week 12.8 ± 1.6 gm/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

  1. 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

  2. Pre-operative clinical and instrumental factors as antireflux surgery outcome predictors

    PubMed Central

    Tolone, Salvatore; Gualtieri, Giorgia; Savarino, Edoardo; Frazzoni, Marzio; de Bortoli, Nicola; Furnari, Manuele; Casalino, Giuseppina; Parisi, Simona; Savarino, Vincenzo; Docimo, Ludovico

    2016-01-01

    Gastroesophageal reflux disease (GERD) is nowadays a highly prevalent, chronic condition, with 10% to 30% of Western populations affected by weekly symptoms. Many patients with mild reflux symptoms are treated adequately with lifestyle modifications, dietary changes, and low-dose proton pump inhibitors (PPIs). For those with refractory GERD poorly controlled with daily PPIs, numerous treatment options exist. Fundoplication is currently the most commonly performed antireflux operation for management of GERD. Outcomes described in current literature following laparoscopic fundoplication indicate that it is highly effective for treatment of GERD; early clinical studies demonstrate relief of symptoms in approximately 85%-90% of patients. However it is still unclear which factors, clinical or instrumental, are able to predict a good outcome after surgery. Virtually all demographic, esophagogastric junction anatomic conditions, as well as instrumental (such as presence of esophagitis at endoscopy, or motility patterns determined by esophageal high resolution manometry or reflux patterns determined by means of pH/impedance-pH monitoring) and clinical features (such as typical or atypical symptoms presence) of patients undergoing laparoscopic fundoplication for GERD can be factors associated with symptomatic relief. With this in mind, we sought to review studies that identified the factors that predict outcome after laparoscopic total fundoplication. PMID:27933133

  3. Pre-operative clinical and instrumental factors as antireflux surgery outcome predictors.

    PubMed

    Tolone, Salvatore; Gualtieri, Giorgia; Savarino, Edoardo; Frazzoni, Marzio; de Bortoli, Nicola; Furnari, Manuele; Casalino, Giuseppina; Parisi, Simona; Savarino, Vincenzo; Docimo, Ludovico

    2016-11-27

    Gastroesophageal reflux disease (GERD) is nowadays a highly prevalent, chronic condition, with 10% to 30% of Western populations affected by weekly symptoms. Many patients with mild reflux symptoms are treated adequately with lifestyle modifications, dietary changes, and low-dose proton pump inhibitors (PPIs). For those with refractory GERD poorly controlled with daily PPIs, numerous treatment options exist. Fundoplication is currently the most commonly performed antireflux operation for management of GERD. Outcomes described in current literature following laparoscopic fundoplication indicate that it is highly effective for treatment of GERD; early clinical studies demonstrate relief of symptoms in approximately 85%-90% of patients. However it is still unclear which factors, clinical or instrumental, are able to predict a good outcome after surgery. Virtually all demographic, esophagogastric junction anatomic conditions, as well as instrumental (such as presence of esophagitis at endoscopy, or motility patterns determined by esophageal high resolution manometry or reflux patterns determined by means of pH/impedance-pH monitoring) and clinical features (such as typical or atypical symptoms presence) of patients undergoing laparoscopic fundoplication for GERD can be factors associated with symptomatic relief. With this in mind, we sought to review studies that identified the factors that predict outcome after laparoscopic total fundoplication.

  4. Comparison of long-term clinical outcomes between sirolimus- and paclitaxel-eluting stents in real-world clinical practice.

    PubMed

    Naito, Ryo; Miyauchi, Katsumi; Konishi, Hirokazu; Tsuboi, Shuta; Ogita, Manabu; Kasai, Takatoshi; Tamura, Hiroshi; Okazaki, Shinya; Daida, Hiroyuki

    2015-11-01

    Advances in percutaneous coronary intervention (PCI) have improved the outcomes of patients with coronary artery diseases. The advent of drug-eluting stents (DES) has dramatically reduced the rate of revascularization. The first-generation DES has yielded the main role of PCI to the second-generation DES; however, many patients had been implanted with the first-generation DES, sirolimus-eluting stents (SES) and paclitaxel-eluting stents (PES). Therefore, it is of importance to detect the long-term clinical outcomes in patients who underwent PCI with SES or PES. We analyzed data from our PCI cohort who underwent PCI with first-generation DES at Juntendo University Hospital between August 2004 and June 2010. The index procedure was analyzed when patients underwent multiple PCIs. Patients who were implanted with both SES and PES were excluded from this study. The study ended on December 31, 2011. The primary outcome was a composite of all-cause mortality and acute coronary syndrome (ACS). The secondary outcome was the rate of target lesion revascularization (TLR) and stent thrombosis. We analyzed data from 861 consecutive patients who underwent implantation of SES or PES. The median follow-up period was 1671 days (interquartile range 1081 and 2105). Kaplan-Meier curves for the primary endpoint did not significantly differ between the two groups (p = 0.8). The incidence of stent thrombosis was 1.4 and 1.8 per 1,000 person-years in the SES and PES groups, respectively (p = 0.9). The rate of TLR was significantly lower in the SES, than the PES group (12.6 and 38.3 per 1,000 person-years, p = 0.03). The rate of TLR was lower in the group treated with SES than PES, but the primary outcome comprising all-cause mortality and ACS was comparable between the two groups.

  5. Improving PTSD Outcomes in OIF/OEF Returnees: A Randomized Clinical Trial of Hydrocortisone Augmentation of Prolonged Exposure Therapy

    DTIC Science & Technology

    2012-08-01

    Award Number: W81XWH-10-2-0072 TITLE: Improving PTSD Outcomes in OIF/OEF Returnees: A Randomized Clinical Trial of Hydrocortisone...SUBTITLE 5a. CONTRACT NUMBER Improving PTSD Outcomes in OIF/OEF Returnees: A Randomized Clinical Trial of Hydrocortisone Augmentation of Prolonged... clinical trial of Prolonged Exposure (PE) with glucocorticoid augmentation (with 30 mg Cortef) or placebo. (0 to 4 months)  Train new study personnel in

  6. Factors influencing polymerase chain reaction outcomes in patients with clinically suspected ocular tuberculosis

    PubMed Central

    2014-01-01

    Background Polymerase chain reaction (PCR) assay can be a useful method for definitive diagnosis in paucibacillary infections such as ocular tuberculosis (TB). In this study, we have evaluated factors affecting PCR outcomes in patients with clinically suspected ocular TB. Patients with clinically suspected ocular TB were investigated by PCR of aqueous or vitreous samples. Three control groups were also tested: group 1 included culture-proven non-tuberculous endophthalmitis, group 2 culture-negative non-tuberculous endophthalmitis, and group 3 patients undergoing surgery for uncomplicated cataract. PCR targeted one or more of following targets: IS6110, MPB64, and protein b genes of Mycobacterium tuberculosis complex. Multiple regression analysis (5% level of significance) was done to evaluate the associations between positive PCR outcome and laterality of disease, tuberculin skin test (TST)/interferon-gamma release assay (IGRA), chest radiography, and type of sample (aqueous or vitreous). The main outcome measures were positive PCR by one or more gene targets, and factors influencing positive PCR outcomes. Results All 114 samples were tested for MPB64, 110 for protein b, and 88 for IS6110. MPB64 was positive in 70.2% (n = 80) of tested samples, protein b in 40.0% (n = 44), and IS6110 in only 9.1% (n = 8). DNA sequencing of amplicons from four randomly chosen PCR reactions showed homology for M. tuberculosis complex. Of the 80 PCR-positive patients, 71 completed a full course of antitubercular therapy, of which 65 patients (91.5%) had complete resolution of inflammation at final follow-up. Among controls, 12.5% (3 out of 24) in group 1 and 18.7% (6 out of 32) in group 2 also tested positive by PCR. No PCR-positive outcome was observed in control group 3 (n = 25). Multiple regression analysis revealed significant association of positive PCR outcome with bilateral presentation, but not with a positive TST/IGRA, chest radiography, or type of sample

  7. 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

  8. Comparison between Radiological and Clinical Outcomes of Laminoplasties with Titanium Miniplates for Cervical Myelopathy

    PubMed Central

    Park, Jong-Hwa; Lee, Ho-Jin; Shin, Byung-Kon

    2016-01-01

    Background Laminoplasty is a surgical procedure frequently performed for cervical myelopathy. We investigated correlations between changes in the anteroposterior diameter (APD) of the spinal canal, spinal canal area (SCA), and laminar angle (LA) and clinical outcomes of laminoplasty. Methods Of the 204 cervical myelopathy patients who underwent laminoplasty from July 2010 to May 2015, 49 patients who were evaluated with pre- and postoperative computed tomography of the cervical vertebrae were included. The average age of the patients was 60.4 years (range, 31 to 82 years), and the average duration of follow-up was 31.6 months (range, 9 to 68 months). Changes in the APD and SCA were measured at the middle of the vertebral body. Changes in LA were measured where both pedicles were clearly visible. Clinical outcomes were assessed using the Japanese Orthopaedic Association (JOA) score and visual analog scale score for pain preoperatively (1 day before surgery) and postoperatively (last outpatient visit) and examining postoperative complications. Results The APD showed an average of 54.7% increase from 11.5 to 17.8 mm. The SCA showed an average of 57.7% increase from 225.9 to 356.3 mm2. The LA increased from 34.2° preoperatively to 71.9° postoperatively. The JOA score increased from an average of 9.1 preoperatively to 13.4 postoperatively. Three patients were found to have hinge fractures during surgery. Postoperative complications, including two cases of C5 palsy, were recorded. The correlation coefficient between the LA change and JOA score improvement was −0.449 (p < 0.05). Patients with a < 33° (25%) increase in the LA showed the most significant clinical improvement. Conclusions Patients with a < 33° (25%) change in the LA after laminoplasty with a titanium miniplate showed the most significant clinical improvement. Thus, LA changes can be useful in predicting the clinical outcome of laminoplasty. PMID:27904722

  9. Rotator Cuff Repair in Patients over 75 Years of Age: Clinical Outcome and Repair Integrity

    PubMed Central

    Park, Jung Gwan; Cho, Nam Su; Song, Jong Hoon; Baek, Jong Hun; Jeong, Ho Yeon

    2016-01-01

    Background Some studies have shown significant functional improvement after rotator cuff (RC) repair in elderly patients. However, few studies have reported the healing potential of RC tears in elderly patients. Methods Twenty-five patients aged ≥ 75 years who underwent RC repair were enrolled. The mean age at the time of surgery was 78.3 years (range, 75 to 88 years) while the mean follow-up was 36.3 months (range, 18 to 114 months). We evaluated clinical and structural outcomes after RC repair in the retear and healed groups. Results Of 25 patients, 16 (64%) had healed RC lesions and 9 (36%) had retorn cuff lesions. The retear rate increased significantly with increasing initial tear size (small to medium, 13%; large, 60%; massive, 80%; p = 0.024) but not with increasing age (p = 0.072). The mean visual analog scale (VAS), University of California Los Angeles (UCLA), and Constant scores significantly improved from 5.2, 15.8, and 49.3 preoperatively to 1.4, 31.1, and 71.9 in the healed group and from 6.0, 14.4, and 39.5 preoperatively to 2.4, 28.3, and 63.6 in the retear group at the final follow-up (p < 0.05, respectively). There were no significant differences in clinical outcomes between the 2 groups at the final follow-up. Retear was significantly correlated with initial tear size (p = 0.001; odds ratio [OR], 2.771; 95% confidence interval [CI], 1.394 to 5.509 for large to massive tears) (p = 0.001; OR, 0.183; 95% CI, 0.048 to 0.692 for small to medium tears). Conclusions There were significant improvements in clinical outcomes after RC repair in patients ≥ 75 years. Structural integrity after cuff repair did not affect the final clinical outcome. Even in elderly patients aged ≥ 75 years, healing of repaired RC can be expected in cases of small to medium tears. Although the retear rate was relatively high for large to massive tears, clinical outcomes still showed significant improvement. PMID:27904725

  10. Effects of a curricular revision on learner outcomes in veterinary clinical pathology.

    PubMed

    Hollinger, Charlotte; Libarkin, Julie C; Stickle, Julia E; Hauptman, Joe G; Henry, Rebecca; Scott, Michael A

    2013-01-01

    A mixed-methods evaluation was conducted to study learner attitudes and knowledge about clinical pathology across a curricular change that instituted a stand-alone clinical pathology course in place of content within a previously integrated pathology course structure. Groups of pre- and post-change students were assessed three times across the two semesters leading up to graduation. At each time, rank-ordered and open-ended response items probed attitudes, and multiple-choice items assessed knowledge. Data about student clinical pathology performance were also collected from clinical pathology instructors and supervising clinicians. Student rank-ordered items were evaluated by factor analysis; resulting factor-scale scores, multiple-choice scores, and rank responses from study cohorts were statistically assessed between groups and within each group over time. Intraclass correlations were calculated for the coding of student open-ended responses, and all coded responses were compared among groups. Analysis revealed that students in the revised curriculum had greater satisfaction with their training and greater confidence in data interpretation compared to students without exposure to an independent clinical pathology course. Although differences in knowledge of clinical pathology were not detected, it was also apparent that the independent clinical pathology course filled a student-perceived curricular need without raising criticisms related to diminished integration with anatomic pathology. Secondary study outcomes included formative feedback for course improvement, evidence of clerkship efficacy, and baseline data for further studies.

  11. The CONSORT Patient-Reported Outcome (PRO) extension: implications for clinical trials and practice

    PubMed Central

    2013-01-01

    To inform clinical guidelines and patient care we need high quality evidence on the relative benefits and harms of intervention. Patient reported outcome (PRO) data from clinical trials can “empower patients to make decisions based on their values” and “level the playing field between physician and patient”. While clinicians have a good understanding of the concept of health-related quality of life and other PROs, evidence suggests that many do not feel comfortable in using the data from trials to inform discussions with patients and clinical practice. This may in part reflect concerns over the integrity of the data and difficulties in interpreting the results arising from poor reporting. The new CONSORT PRO extension aims to improve the reporting of PROs in trials to facilitate the use of results to inform clinical practice and health policy. While the CONSORT PRO extension is an important first step in the process, we need broader engagement with the guidance to facilitate optimal reporting and maximize use of PRO data in a clinical setting. Endorsement by journal editors, authors and peer reviewers are crucial steps. Improved design, implementation and transparent reporting of PROs in clinical trials are necessary to provide high quality evidence to inform evidence synthesis and clinical practice guidelines. PMID:24168680

  12. Reverse shoulder arthroplasty. Part 1: Systematic review of clinical and functional outcomes

    PubMed Central

    Samitier, Gonzalo; Alentorn-Geli, Eduard; Torrens, Carlos; Wright, Thomas W.

    2015-01-01

    Many factors influence the outcomes of reverse shoulder arthroplasty (RSA). The purpose of this study was to compare the clinical and functional outcomes of RSA depending on the surgical approach, type of prosthesis, and indication for surgery through a comprehensive, systematic review. A literature search was conducted (1985 to June 2012) using PubMed, CINAHL, EBSCO–SPORTDiscus, and Cochrane Central Register of Controlled Trials. Levels I–IV evidence, in-vivo human studies (written in English with minimum of 2 years of follow-up and sample size of 10 patients) reporting clinical and/or functional outcomes after RSA were included. The outcomes were analyzed depending on the surgical approach, type of prosthesis (with medialized or lateralized center of rotation), or indication for surgery. A total of 35 studies were included involving 2049 patients (mean [SD] percentage of females, age, and follow-up of 71.6% [13.4], 71.5 years [3.7], and 43.1 months [18.8], respectively). Studies using deltopectoral approach with lateralized prostheses demonstrated greater improvement in external rotation compared with medialized prostheses with the same approach (mean 22.9° and 5°, respectively). In general, RSA for cuff tear arthropathy demonstrated higher improvements in Constant and American Shoulder and Elbow Society scores, and range of motion compared with revision of anatomic prosthesis, failed rotator cuff repair, and fracture sequelae. Lateralized prostheses provided more improvement in external rotation compared to medialized prostheses. Indications of RSA for cuff tear arthropathy demonstrated higher improvements in the outcomes compared with other indications. RSA demonstrated high patient's satisfaction regardless of the type of prosthesis or indication for surgery. Level of Evidence: Level IV. PMID:25709242

  13. Effect of Donor Graft Quality on Clinical Outcomes After Penetrating Keratoplasty for Keratoconus

    PubMed Central

    Feizi, Sepehr; Javadi, Mohammad Ali; Ghasemi, Hassan; Javadi, Fatemeh

    2015-01-01

    Purpose: To evaluate the effect of donor and eye bank characteristics on graft rating and clinical outcomes after penetrating keratoplasty (PK) for keratoconus. Methods: This retrospective interventional case series included 252 keratoconic eyes which underwent PK. Donor data included age and sex, cause of death, death-to-preservation time, preservation-to-surgery time, epithelial and stromal status, endothelial cell density (ECD) and morphology, and graft rating. Postoperative outcomes included visual acuity, refractive error, epithelial problems, suture-related complications, graft rejection, and graft transparency. Multivariate regression analysis assessed correlations between donor and eye bank characteristics and graft quality, and postoperative outcomes. Results: Mean recipient and donor age was 29.7 ± 10.0 and 26.2 ± 8.8 years, respectively and mean follow-up period was 66.7 ± 38.5 months. Death-to-preservation time was significantly associated with the presence of graft epithelial sloughing (P = 0.005) and stromal cloudiness (P < 0.001). Donor age significantly influenced ECD (P = 0.02), mean cell area (P = 0.04), and hexagonality (P = 0.01). The presence of epithelial defects on postoperative day 1 correlated significantly with death-to-preservation time (P = 0.004). Graft stromal edema on postoperative day 1 was significantly associated with graft epithelial sloughing (P < 0.001). Postoperative visual and refractive outcomes, complications, and graft survival were not correlated with any donor or eye bank factors. Conclusion: Donor and eye bank variables affected the quality of donor corneas and early postoperative course. However, their long term effect on clinical outcomes, complications, and graft survival were insignificant. PMID:27051479

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

    PubMed Central

    Choi, Wook Jin

    2016-01-01

    The incidence and mortality of gastric cancer have been steadily decreased over the past few decades. However, gastric cancer is still one of the leading causes of cancer deaths across many regions of the world, particularly in Asian countries. In previous studies, nutrition has been considered one of significant risk factors in gastric cancer patients. Especially, malnourished patients are at greater risk of adverse clinical outcomes (e.g., longer hospital stay) and higher incidence of complications (e.g., wound/infectious complications) compared to well-nourished patients. Malnutrition is commonly found in advanced gastric cancer patients due to poor absorption of essential nutrients after surgery. Therefore, nutritional support protocols, such as early oral and enternal feeding, have been proposed in many studies, to improve unfavorable clinical outcomes and to reduce complications due to delayed application of oral nutritional support or parental feeding. Also, the supplied with enternal immune-enriched diet had more benefits in improving clinical outcomes and fewer complications compared to a group supplied with control formula. Using nutritional screening tools, such as nutritional risk index (NRI) and nutritional risk screening (NRS 2002), malnourished patients showed higher incidence of complications and lower survival rates than non-malnourished patients. However, a long-term nutritional intervention, such as nutritional counseling, was not effective in the patients. Therefore, early assessment of nutritional status in patients using a proper nutritional screening tool is suggested to prevent malnutrition and adverse health outcomes. Further studies with numerous ethnic groups may provide stronger scientific evidences in association between nutritional care and recovery from surgery in patients with gastric cancer. PMID:27152296

  15. Clinical Characteristics and Treatment Outcomes of Patients with Macrolide-Resistant Mycobacterium massiliense Lung Disease.

    PubMed

    Choi, Hayoung; Kim, Su-Young; Lee, Hyun; Jhun, Byung Woo; Park, Hye Yun; Jeon, Kyeongman; Kim, Dae Hun; Huh, Hee Jae; Ki, Chang-Seok; Lee, Nam Yong; Lee, Seung-Heon; Shin, Sung Jae; Daley, Charles L; Koh, Won-Jung

    2017-02-01

    Macrolide antibiotics are cornerstones in the treatment of Mycobacterium massiliense lung disease. Despite the emergence of resistance, limited data on macrolide-resistant M massiliense lung disease are available. This study evaluated the clinical features and treatment outcomes of patients and the molecular characteristics of macrolide-resistant M massiliense isolates. We performed a retrospective review of medical records and genetic analyses of clinical isolates from 15 patients who had macrolide-resistant M massiliense lung disease between September 2005 and February 2015. Nine patients (60%) had the nodular bronchiectatic form of the disease, and six (40%) had the fibrocavitary form. Before the detection of macrolide resistance, three patients (20%) were treated with macrolide monotherapy, four (27%) with therapy for presumed Mycobacterium avium complex infections, and eight (53%) with combination antibiotic therapy for M massiliense lung disease. The median treatment duration after the detection of resistance was 18.7 months (interquartile range, 11.2 to 39.8 months). Treatment outcomes were poor, with a favorable outcome being achieved for only one patient (7%), who underwent surgery in addition to antibiotic therapy. The 1-, 3-, and 5-year mortality rates were 7, 13, and 33%, respectively. Of the 15 clinical isolates, 14 (93%) had point mutations at position 2058 (n = 9) or 2059 (n = 5) of the 23S rRNA gene, resulting in macrolide resistance. Our study indicates that treatment outcomes are poor and mortality rates are high after the development of macrolide resistance in patients with M massiliense lung disease. Thus, preventing the development of macrolide resistance should be a key consideration during treatment.

  16. Asymptomatic Mild Hyperperfusion for the Prediction of Clinical Outcome in Postoperative Patients After Subarachnoid Hemorrhage

    PubMed Central

    Nakagawa, Manabu; Mutoh, Tatsushi; Takenaka, Shunsuke; Mutoh, Tomoko; Totsune, Tomoko; Taki, Yasuyuki; Ishikawa, Tatsuya

    2017-01-01

    Background Delayed cerebral ischemia (DCI) is one of the main causes of poor outcomes after subarachnoid hemorrhage (SAH). The early identification of DCI by noninvasive imaging modalities would provide valuable information of therapeutic intervention for improving the patient outcomes. We aimed to describe the clinical features of cerebral blood flow (CBF) data obtained from the single-photon emission computed tomography (SPECT) during the risk period for DCI after SAH. Material/Methods Clinical data from 94 SAH patients who underwent surgical clipping of anterior circulation aneurysms were reviewed retrospectively. 99mTc-HMPAO SPECT images were visually and semiquantitatively analyzed on days 7 and 14 after SAH. Results In all cases, the areas of hypoperfusion were found in the middle cerebral artery territories. By contrast, the areas of mild hyperperfusion were always detected on the surgical side, the prevalence which increased from days 7 (n=28; 30%) to 14 (n=48; 51%) without neurological defects. Univariate analysis revealed that the hyperperfusion on day 14 had a significant relationship with functional outcome at 3 months (P=0.04). Multivariate analysis including age, clinical SAH grade, DCI, and hyperperfusion on day 14 showed that DCI (P=0.004; odds ratio [OR], 0.10; 95% confidence interval [CI], 0.02–0.48) and hyperperfusion on day 14 (P=0.002; OR, 2.44; 95% CI, 1.40–4.29) were independently associated with functional outcome at 3 months. Conclusions Delayed mild hyperperfusion around the surgical site can predict good prognosis after SAH, although it may hinder the CBF diagnosis of focal ischemia attributable to DCI. PMID:28093563

  17. The Association of Visual Impairment With Clinical Outcomes in Hemodialysis Patients.

    PubMed

    Hong, Yu Ah; Kim, Suk Young; Kim, Su-Hyun; Kim, Young Ok; Jin, Dong Chan; Song, Ho Chul; Choi, Euy Jin; Kim, Yong-Lim; Kim, Yon-Su; Kang, Shin-Wook; Kim, Nam-Ho; Yang, Chul Woo; Kim, Yong Kyun

    2016-05-01

    Visual impairment limits people's ability to perform daily tasks and affects their quality of life. We evaluated the impact of visual impairment on clinical outcomes in hemodialysis (HD) patients.HD patients were selected from the Clinical Research Center registry a prospective cohort study on dialysis patients in Korea. Visual impairment was defined as difficulty in daily life due to decreased visual acuity or blindness. The primary outcome was all-cause mortality and the secondary outcomes were cardiovascular and infection-related hospitalization.A total of 3250 patients were included. Seven hundred thirty (22.5%) of the enrolled patients had visual impairment. The median follow-up period was 30 months. The Kaplan-Meier curve and log-rank test showed that all-cause mortality rates (P < 0.001) as well as cardiovascular and infection-related hospitalization rates (P < 0.001 and P < 0.001) were significantly higher in patients with visual impairment than in patients without visual impairment. In the multivariable analysis, visual impairment had significant predictive power for all-cause mortality (Hazard ratio [HR], 1.77, 95% confidence interval [CI], 1.21-2.61, P = 0.004) and cardiovascular hospitalization (HR 1.45 [1.00-1.90], P = 0.008) after adjusting for confounding variables. Of these 3250 patients, 634 patients from each group were matched by propensity scores. In the propensity score matched analysis, patients with visual impairment had independently significant associations with increased all-cause mortality (HR 1.69 [1.12-2.54], P = 0.01) and cardiovascular hospitalization (HR 1.48 [1.08-2.02], P = 0.01) compared with patients without visual impairment after adjustment for confounding variables.Our data demonstrated that visual impairment was an independent risk factor for clinical adverse outcomes in HD patients.

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

    PubMed

    Choi, Wook Jin; Kim, Jeongseon

    2016-04-01

    The incidence and mortality of gastric cancer have been steadily decreased over the past few decades. However, gastric cancer is still one of the leading causes of cancer deaths across many regions of the world, particularly in Asian countries. In previous studies, nutrition has been considered one of significant risk factors in gastric cancer patients. Especially, malnourished patients are at greater risk of adverse clinical outcomes (e.g., longer hospital stay) and higher incidence of complications (e.g., wound/infectious complications) compared to well-nourished patients. Malnutrition is commonly found in advanced gastric cancer patients due to poor absorption of essential nutrients after surgery. Therefore, nutritional support protocols, such as early oral and enternal feeding, have been proposed in many studies, to improve unfavorable clinical outcomes and to reduce complications due to delayed application of oral nutritional support or parental feeding. Also, the supplied with enternal immune-enriched diet had more benefits in improving clinical outcomes and fewer complications compared to a group supplied with control formula. Using nutritional screening tools, such as nutritional risk index (NRI) and nutritional risk screening (NRS 2002), malnourished patients showed higher incidence of complications and lower survival rates than non-malnourished patients. However, a long-term nutritional intervention, such as nutritional counseling, was not effective in the patients. Therefore, early assessment of nutritional status in patients using a proper nutritional screening tool is suggested to prevent malnutrition and adverse health outcomes. Further studies with numerous ethnic groups may provide stronger scientific evidences in association between nutritional care and recovery from surgery in patients with gastric cancer.

  19. Peripheral Artery Disease and Chronic Kidney Disease: Clinical Synergy to Improve Outcomes

    PubMed Central

    Garimella, Pranav S.; Hirsch, Alan T.

    2014-01-01

    Persons with chronic kidney disease (CKD) are at a higher risk of developing peripheral artery disease (PAD) and its adverse health outcomes than individuals in the general population who have normal renal function. Classic atherosclerosis risk factors care (e.g., age, smoking, diabetes, hypertension and hyperlipidemia) are common in CKD patients, but CKD also imposes additional unique risk factors that promote arterial disease (e.g., chronic inflammation, hypoalbuminemia and a pro-calcific state). Current nephrology clinical practice is adversely impacted by PAD diagnostic challenges, the complexities of managing two serious comorbid diseases, delayed vascular specialist referral, and slow PAD treatment initiation in CKD patients. Persons with CKD are less likely to be provided recommended ‘optimal’ PAD care. The knowledge that both limb and mortality outcomes are significantly worse in CKD patients, especially those on dialysis, is not a biologic fact, but can serve as a care delivery call to action. Nephrologists can facilitate positive change. This manuscript proposes that patients with PAD and CKD be strategically co-managed by care teams that encompass the skills to create and use evidence-based care pathways. This proposed collaborative multidisciplinary approach will include vascular medicine specialists, nephrologists, wound specialists and mid-level providers. Just as clinical care quality metrics have served as the base for ESRD and acute MI quality improvement, it is time that such quality outcomes metrics be initiated for the large PAD-CKD population. This new system will identify and resolve key gaps in the current care model so that clinical outcomes improve within a cost-effective care frame for this vulnerable population. PMID:25443571

  20. Six-month clinical outcomes after hyperopic correction with the SCHWIND AMARIS Total-Tech laser

    PubMed Central

    Arbelaez, María Clara; Vidal, Camila; Arba Mosquera, Samuel

    2011-01-01

    Purpose To evaluate postoperative clinical outcomes, and corneal High Order Aberrations, among eyes with hyperopia up to +5 D of spherical equivalent, that have undergone LASIK treatments using the SCHWIND AMARIS laser system. Methods At six-month follow-up, 100 eyes with preoperative hyperopia or hyperopic astigmatism up to +5 D of spherical equivalent were retrospectively analysed. Standard examinations, pre- and postoperative wavefront analysis with a corneal-wavefront-analyzer (OPTIKON Scout) were performed. Aberration-Free aspheric treatments were planned with Custom Ablation Manager software and ablations performed using the SCHWIND AMARIS flying-spot excimer laser system (both SCHWIND eye-tech-solutions). LASIK flaps were created using a LDV femtosecond laser (Ziemer Group) in all cases. Clinical outcomes were evaluated in terms of predictability, refractive outcome, safety, and wavefront aberration. Results At six month, 90 % of eyes achieved ≥ 20/25 UCVA and 44 % achieved ≥ 20/16 UCVA. Seventy-four percent of eyes were within ± 0.25D of spherical equivalent and 89 % within ± 0.50D, with 94 % within 0.50D of astigmatism. Mean spherical equivalent was −0.12 ± 0.51D and 0.50 ± 0.51D for the astigmatism. Fifty-two percent of eyes improved BSCVA vs. only 19 % losing lines of BSCVA. Predictability slope for refraction was 1.03 and intercept +0.01 D. On average, negative corneal spherical aberrations were significantly increased by the treatments, no other aberration terms changed from pre- to postoperative values. Conclusions LASIK for hyperopia and hyperopic astigmatism with SCHWIND AMARIS yields very satisfactory visual outcomes. Preoperative refractions were postoperatively reduced to subclinical values with no clinically relevant induction of corneal HOA.

  1. Using ClinicalTrials.gov to Supplement Information in Ophthalmology Conference Abstracts about Trial Outcomes: A Comparison Study

    PubMed Central

    Scherer, Roberta W.; Huynh, Lynn; Ervin, Ann-Margret; Dickersin, Kay

    2015-01-01

    Background Including results from unpublished randomized controlled trials (RCTs) in a systematic review may ameliorate the effect of publication bias in systematic review results. Unpublished RCTs are sometimes described in abstracts presented at conferences, included in trials registers, or both. Trial results may not be available in a trials register and abstracts describing RCT results often lack study design information. Complementary information from a trials register record may be sufficient to allow reliable inclusion of an unpublished RCT only available as an abstract in a systematic review. Methods We identified 496 abstracts describing RCTs presented at the 2007 to 2009 Association for Research in Vision and Ophthalmology (ARVO) meetings; 154 RCTs were registered in ClinicalTrials.gov. Two persons extracted verbatim primary and non-primary outcomes reported in the abstract and ClinicalTrials.gov record. We compared each abstract outcome with all ClinicalTrials.gov outcomes and coded matches as complete, partial, or no match. Results We identified 800 outcomes in 152 abstracts (95 primary [51 abstracts] and 705 [141 abstracts] non-primary outcomes). No outcomes were reported in 2 abstracts. Of 95 primary outcomes, 17 (18%) agreed completely, 53 (56%) partially, and 25 (26%) had no match with a ClinicalTrials.gov primary or non-primary outcome. Among 705 non-primary outcomes, 56 (8%) agreed completely, 205 (29%) agreed partially, and 444 (63%) had no match with a ClinicalTrials.gov primary or non-primary outcome. Among the 258 outcomes partially agreeing, we found additional information on the time when the outcome was measured more often in ClinicalTrials.gov than in the abstract (141/258 (55%) versus 55/258 (21%)). We found no association between the presence of non-matching “new” outcomes and year of registration, time to registry update, industry sponsorship, or multi-center status. Conclusion Conference abstracts may be a valuable source of

  2. Prime time: 18-month violence outcomes of a clinic-linked intervention.

    PubMed

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

    2014-08-01

    Prime Time, a youth development intervention, aims to reduce multiple risk behaviors among adolescent girls seeking clinic services who are at high risk for pregnancy. The purpose of the current study was to examine whether Prime Time involvement produced changes in relational aggression, physical violence, and related psychosocial and behavioral outcomes. Qualitative case exemplars illustrated social contexts of intervention participants with differing longitudinal patterns of relational aggression and physical violence. Data were from a randomized efficacy trial with 13-17 year-old girls (n = 253) meeting specified risk criteria. Intervention participants were involved in Prime Time and usual clinic services for 18 months, control participants received usual clinic services. Participants in the current study completed self-report surveys at baseline and 18 months following enrollment. Outcomes analyses revealed significantly lower levels of relational aggression perpetration in the intervention group versus controls. In contrast, Prime Time involvement did not result in significant reductions in physical violence. Exploratory dose-response analyses indicated that reductions in relational aggression may have been most pronounced among girls actively involved in Prime Time case management and peer leadership activities. Qualitative findings suggested that the intervention's emphasis on modeling and building supportive relationships contributed to reductions in relational aggression. This study contributes to what has been a very limited evidence base regarding effective approaches to preventing violence among high-risk adolescent girls. Findings suggest that offering youth development interventions through clinic settings hold promise in reducing violence risk among vulnerable youth.

  3. Blastocyst culture and cryopreservation to optimize clinical outcomes of warming cycles.

    PubMed

    Zhu, Lixia; Xi, Qingsong; Zhang, Hanwang; Li, Yufeng; Ai, Jihui; Jin, Lei

    2013-08-01

    Surplus embryos available for cryopreservation in fresh cycles are considered as having good potential for future use. However, the optimal stage of embryo cryopreservation remains unclear. In this study, 1190 patients with surplus embryos on day 3 were divided into two groups: cleavage-stage embryo cryopreservation (control group) and blastocyst cryopreservation (blastocyst group). The clinical outcomes of the subsequent warming cycles were evaluated. The proportion of cycles with blastocyst formation was 73.8% in the blastocyst group. Although in the blastocyst group, the cancellation rate of blastocyst transfer was increased due to lack of blastocysts available for cryopreservation, the blastocyst group achieved significantly higher rates of clinical pregnancy/cycle (43.2% versus 34.9%; P=0.003), pregnancy/transfer (59.5% versus 35.4%; P<0.001) and implantation (46.5% versus 22.2%; P<0.001) from the first warming cycle compared with the control group. In an embryo-number classified analysis, the clinical pregnancy rate was also higher in the blastocyst group. However, the cumulative pregnancy was similar between the two groups. Blastocyst culture as an embryo selection tool will not improve embryo viability but it will help patients to achieve pregnancy more quickly. Extended culture of surplus embryos to the blastocyst stage for cryopreservation optimizes the clinical outcomes.

  4. Client Preferences Affect Treatment Satisfaction, Completion, and Clinical Outcome: A Meta-Analysis

    PubMed Central

    Lindhiem, Oliver; Bennett, Charles B.; Trentacosta, Christopher J.; McLear, Caitlin

    2014-01-01

    We conducted a meta-analysis on the effects of client preferences on treatment satisfaction, completion, and clinical outcome. Our search of the literature resulted in 34 empirical articles describing 32 unique clinical trials that either randomized some clients to an active choice condition (shared decision making condition or choice of treatment) or assessed client preferences. Clients who were involved in shared decision making, chose a treatment condition, or otherwise received their preferred treatment evidenced higher treatment satisfaction (ESd = .34; p < .001), increased completion rates (ESOR = 1.37; ESd = .17; p < .001), and superior clinical outcome (ESd = .15; p < .0001), compared to clients who were not involved in shared decision making, did not choose a treatment condition, or otherwise did not receive their preferred treatment. Although the effect sizes are modest in magnitude, they were generally consistent across several potential moderating variables including study design (preference versus active choice), psychoeducation (informed versus uninformed), setting (inpatient versus outpatient), client diagnosis (mental health versus other), and unit of randomization (client versus provider). Our findings highlight the clinical benefit of assessing client preferences, providing treatment choices when two or more efficacious options are available, and involving clients in treatment-related decisions when treatment options are not available. PMID:25189522

  5. Do various baseline characteristics of transversus abdominis and lumbar multifidus predict clinical outcomes in nonspecific low back pain? A systematic review.

    PubMed

    Wong, Arnold Y L; Parent, Eric C; Funabashi, Martha; Stanton, Tasha R; Kawchuk, Gregory N

    2013-12-01

    Although individual reports suggest that baseline morphometry or activity of transversus abdominis or lumbar multifidus predict clinical outcome of low back pain (LBP), a related systematic review is unavailable. Therefore, this review summarized evidence regarding the predictive value of these muscular characteristics. Candidate publications were identified from 6 electronic medical databases. After review, 5 cohort studies were included. Although this review intended to encompass studies using different muscle assessment methods, all included studies coincidentally used ultrasound imaging. No research investigated the relation between static morphometry and clinical outcomes. Evidence synthesis showed limited evidence supporting poor baseline transversus abdominis contraction thickness ratio as a treatment effect modifier favoring motor control exercise. Limited evidence supported that high baseline transversus abdominis lateral slide was associated with higher pain intensity after various exercise interventions at 1-year follow-up. However, there was limited evidence for the absence of relation between the contraction thickness ratio of transversus abdominis or anticipatory onset of lateral abdominal muscles at baseline and the short- or long-term LBP intensity after exercise interventions. There was conflicting evidence for a relation between baseline percent thickness change of lumbar multifidus during contraction and the clinical outcomes of patients after various conservative treatments. Given study heterogeneity, the small number of included studies and the inability of conventional greyscale B-mode ultrasound imaging to measure muscle activity, our findings should be interpreted with caution. Further large-scale prospective studies that use appropriate technology (ie, electromyography to assess muscle activity) should be conducted to investigate the predictive value of morphometry or activity of these muscles with respect to LBP-related outcomes measures.

  6. The pharmacology and clinical outcomes of amphetamines to treat ADHD: does composition matter?

    PubMed

    Hodgkins, Paul; Shaw, Monica; McCarthy, Suzanne; Sallee, Floyd R

    2012-03-01

    Attention-deficit hyperactivity disorder (ADHD) treatment options include pharmacological and nonpharmacological approaches. In North America, psychostimulants (amphetamine and methylphenidate) are considered first-line pharmacological treatments for patients (children, adolescents and adults) with ADHD. However, in the UK, National Institute for Health and Clinical Excellence (NICE) guidelines have placed short-acting d-amphetamine as a third-line treatment option due to a lack of contemporary, published clinical trials on its efficacy and the concerns from clinical and patient experts regarding the potential for increased abuse and/or misuse compared with methylphenidate. These guidelines do not account for some of the more recent amphetamine products that have been developed to alleviate some of these concerns, but that are not currently approved in the UK or other European countries. The purpose of this review is to describe the pharmacology and clinical efficacy of various amphetamine compositions, as well as to explore the apparent differences in these compositions and their associated risks and benefits. A PubMed literature search was conducted to investigate amphetamine pharmacology, clinical efficacy and safety and ADHD outcomes in the published literature from 1980 through March 2011. Search terms included the keywords 'ADHD' or 'ADD' or 'hyperkinetic disorder' and any of the following keywords combined with 'or': 'amphetamine', 'dexamphetamine', 'mixed amphetamine salts', 'lisdexamfetamine' and 'methamphetamine'. The search included English-language primary research articles and review articles but excluded editorial articles and commentaries. The literature search resulted in 330 articles. Pertinent articles relating to amphetamine pharmacology, compositions, clinical efficacy and safety, effectiveness and tolerability, ADHD outcomes and abuse liability were included in this review. The different delivery profiles of amphetamine compositions result in

  7. Effects of clinical practice environments on clinical teacher and nursing student outcomes.

    PubMed

    Babenko-Mould, Yolanda; Iwasiw, Carroll L; Andrusyszyn, Mary-Anne; Laschinger, Heather K S; Weston, Wayne

    2012-04-01

    The purpose of this study was to use a cross-sectional survey design, with an integrated theoretical perspective, to examine clinical teachers' (n = 64) and nursing students' (n = 352) empowerment, teachers' and students' perceptions of teachers' use of empowering teaching behaviors, students' perceptions of nurses' practice behaviors, and students' confidence for practice in acute care settings. In this study, teachers and students were moderately empowered. Teachers reported using a high level of empowering teaching behaviors, which corresponded with students' perceptions of teachers' use of such behaviors. Teachers' empowerment predicted 21% of their use of empowering teaching behaviors. Students reported nurses as using a high level of professional practice behaviors. Students felt confident for professional nursing practice. The findings have implications for practice contexts related to empowering teaching-learning environments and self-efficacy.

  8. Cartilage repair: synthetics and scaffolds: basic science, surgical techniques, and clinical outcomes.

    PubMed

    Kerker, Jordan T; Leo, Andrew J; Sgaglione, Nicholas A

    2008-12-01

    Symptomatic articular cartilage lesions have gained attention and clinical interest in recent years and can be difficult to treat. Historically, various biologic surgical treatment options have yielded inconsistent results because of the inferior biomechanical properties associated with a variable healing response. Improving technology and surgical advances has generated considerable research in cartilage resurfacing and optimizing hyaline tissue restoration. Biologic innovation and tissue engineering in cartilage repair have used matrix scaffolds, autologous and allogenic chondrocytes, cartilage grafts, growth factors, stem cells, and genetic engineering. Numerous evolving technologies and surgical approaches have been introduced into the clinical setting. This review will discuss the basic science, surgical techniques, and clinical outcomes of novel synthetic materials and scaffolds for articular cartilage repair.

  9. Borderline personality disorder: patterns of self-harm, reported childhood trauma and clinical outcome

    PubMed Central

    Milner, Rebecca; Gavin, Victoria; Levita, Liat

    2015-01-01

    Summary Consecutive admissions of 214 women with borderline personality disorder were investigated for patterns of specific forms of self-harm and reported developmental experiences. Systematic examination of clinical notes found that 75% had previously reported a history of childhood sexual abuse. These women were more likely to self-harm, and in specific ways that may reflect their past experiences. Despite this, treatment within a dialectical behaviour therapy-informed therapeutic community leads to relatively greater clinical gains than for those without a reported sexual abuse trauma history. Notably, greater behavioural and self-reported distress and dissociation were not found to predict poor clinical outcome. Declaration of interest None. Copyright and usage © The Royal College of Psychiatrists 2015. This is an open access article distributed under the terms of the Creative Commons Non-Commercial, No Derivatives (CC BY-NC-ND) licence. PMID:27703718

  10. Clinical terminology support for a national ambulatory practice outcomes research network.

    PubMed

    Ricciardi, Thomas N; Lieberman, Michael I; Kahn, Michael G; Masarie, F E

    2005-01-01

    The Medical Quality Improvement Consortium (MQIC) is a nationwide collaboration of 74 healthcare delivery systems, consisting of 3755 clinicians, who contribute de-identified clinical data from the same commercial electronic medical record (EMR) for quality reporting, outcomes research and clinical research in public health and practice benchmarking. Despite the existence of a common, centrally-managed, shared terminology for core concepts (medications, problem lists, observation names), a substantial "back-end" information management process is required to ensure terminology and data harmonization for creating multi-facility clinically-acceptable queries and comparable results. We describe the information architecture created to support terminology harmonization across this data-sharing consortium and discuss the implications for large scale data sharing envisioned by proponents for the national adoption of ambulatory EMR systems.

  11. Clinical differentiation and outcome evaluation in vegetative and minimally conscious state patients: the neurophysiological approach

    PubMed Central

    De Salvo, Simona; Bramanti, Placido; Marino, Silvia

    2012-01-01

    Summary The neurophysiological approach to patients with disorders of consciousness allows recording of both central and peripheral nervous system electrical activities and provides a functional assessment. Data obtained using this approach can supplement information from clinical neurological examination, but also from the use of morphological neuroimaging techniques: computed tomography and magnetic resonance imaging. Neurophysiological techniques, such as electroencephalography (EEG), evoked potentials, transcranial magnetic stimulation, and EEG in association with functional magnetic resonance imaging, allow monitoring of clinical conditions and can help in the formulation of a prognosis. The aim of this review is to describe the main neurophysiological techniques used in disorders of consciousness to evaluate residual cerebral function, to provide information on the neuronal dysfunction for outcome evaluation, and to differentiate clinically between the vegetative and minimally conscious states. PMID:23402676

  12. Improvement in Growth After 1 Year of Growth Hormone Therapy in Well-Nourished Infants with Growth Retardation Secondary to Chronic Renal Failure: Results of a Multicenter, Controlled, Randomized, Open Clinical Trial

    PubMed Central

    Moreno, M. Llanos; Neto, Arlete; Ariceta, Gema; Vara, Julia; Alonso, Angel; Bueno, Alberto; Afonso, Alberto Caldas; Correia, António Jorge; Muley, Rafael; Barrios, Vicente; Gómez, Carlos; Argente, Jesús

    2010-01-01

    Background and objectives: Our aim was to evaluate the growth-promoting effect of growth hormone (GH) treatment in infants with chronic renal failure (CRF) and persistent growth retardation despite adequate nutritional and metabolic