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Sample records for 1-year clinical outcomes

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

    PubMed

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

    2009-02-01

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

  2. The Association between Neighborhood Socioeconomic Status and Clinical Outcomes among Patients 1 Year after Hospitalization for Cardiovascular Disease

    PubMed Central

    Villanueva, Carolina; Aggarwal, Brooke

    2013-01-01

    Residing in lower socioeconomic status neighborhoods is associated with increased risk of morbidity and mortality. Few studies have examined this association for cardiovascular disease (CVD) outcomes in a treated population in New York City (NYC). The purpose of this study was to determine the relationship between neighborhood level poverty and one-year clinical outcomes (rehospitalization and/or death) among hospitalized patients with CVD. Data on rehospitalization and/or death at one-year were collected from consecutive patients admitted at a university medical center in NYC from November 2009 to September 2010. NYC residents totaled 2,198. U.S. Census 2000 zip code data was used to quantify neighborhood SES into quintiles of poverty (Q1=lowest poverty to Q5=highest poverty). Univariate analyses were used to determine associations between neighborhood poverty and baseline characteristics and comorbidities. A logistic regression analysis was used to calculate odds ratios for the association between quintiles of poverty and rehospitalization/death at one year. Fifty-five percent of participants experienced adverse outcomes. Participants in Q5 (9%) were more likely to be female (odds ratio [OR]=0.49,95% confidence interval [CI] 0.33–0.73), younger (OR=0.50,95% CI 0.34–0.74), of minority race/ethnicity (OR=18.24,95% CI 11.12=29.23), and have no health insurance (OR=4.79,95% CI 2.92–7.50). Living in Q5 was significantly associated with increased comorbidities, including diabetes mellitus and hypertension, but was not a significant predictor of rehospitalization/death at one year. Among patients hospitalized with CVD, higher poverty neighborhood residence was significantly associated with a greater prevalence of comorbidities, but not of rehospitalization and/or death. Affordable, accessible resources targeted at reducing the risk of developing CVD and these comorbidities should be available in these communities. PMID:23468321

  3. Treatment discontinuation and clinical outcomes in the 1-year naturalistic treatment of patients with schizophrenia at risk of treatment nonadherence

    PubMed Central

    Kelin, Katarina; Lambert, Timothy JR; Brnabic, Alan JM; Newton, Richard; Ye, Wendy; Escamilla, Raúl I; Chen, Kuang-Peng; Don, Liana; Montgomery, William; Karagianis, Jamie; Ascher-Svanum, Haya

    2011-01-01

    Background: This study aimed to improve physicians’ understanding of the treatment circumstances and needs of outpatients with schizophrenia at risk of nonadherence, by naturalistically assessing antipsychotic treatment patterns, clinical outcomes, and health care service use in this little-studied patient population. Methods: In this one-year, prospective, multicenter, noninterventional, observational study, patients considered at risk of nonadherence by their physicians were switched from their primary oral antipsychotic to another oral or a depot antipsychotic at study entry. All cause treatment discontinuation (antipsychotic switch, augmentation, or discontinuation) during the study was assessed using Kaplan–Meier survival analyses and descriptive statistics. Patients’ illness severity, quality of life, attitude towards medication, patient-reported adherence, and health care resource utilization were assessed during the study. Results: Of the 406 enrolled patients, 43 (10.6%) were switched to depot and 363 (89.4%) were switched to oral antipsychotics at study entry. During the study, 99 (24.4%) patients switched, augmented, or discontinued their antipsychotic (all cause treatment discontinuation). Of the 99 patients who switched, augmented, or discontinued their antipsychotic, 8 (18.6%) were taking depot and 91 (25.0%) were taking oral antipsychotics. These patients were switched to either depot (n = 15) or oral (n = 78) antipsychotics, or discontinued their antipsychotic medication (n = 6). Inadequate response was the most frequently reported reason for medication discontinuation. During the study, patients’ clinical and functional status improved significantly and service use was low. Most patients considered themselves to be adherent at study entry, and this favorable self-perception increased during the study (from 68.5% to 88.1%). Conclusion: Although identified as at risk of nonadherence, few patients in this naturalistic study discontinued their

  4. 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

  5. Incidence, Predictors and Impact of Severe Periprocedural Bleeding According to VARC-2 Criteria on 1-Year Clinical Outcomes in Patients After Transcatheter Aortic Valve Implantation.

    PubMed

    Kochman, Janusz; Rymuza, Bartosz; Huczek, Zenon; Kołtowski, Łukasz; Ścisło, Piotr; Wilimski, Radosław; Ścibisz, Anna; Stanecka, Paulina; Filipiak, Krzysztof J; Opolski, Grzegorz

    2016-01-01

    There are differences in reporting bleeding complications after transcatheter aortic valve implantation (TAVI), which is a consequence of the lack of consensus for their definition. Furthermore, the amount of data on the impact of peri-procedural bleeding on the mid-term prognosis is still limited. The aim of this study was to investigate the incidence, predictors, and impact of life-threatening and major bleedings as defined by the Valve Academic Research Consortium 2 (VARC-2) in patients after TAVI over the mid-term prognosis.Consecutive patients who underwent TAVI from March 2010 to December 2013 were included. All data were classified according to the VARC-2 criteria. We assessed the incidence and the predictors of serious bleeding events (SBE), defined as life-threatening/disabling (LT/D) or major bleeding, and analyzed their impact on 30-day and 1-year clinical outcome.A total of 129 patients were included (79.1 ± 8.3 years; mean EuroSCORE = 17.8 ± 12.7). The SBE occurred in 25 patients (19.4%), of which 9 (7.0%) had LT/D and 16 (12.4%) had major bleeding. Trans-subclavian (TS) access (OR 4.38, 95% CI 2.13-14.29, P = 0.01) and diabetes (OR 2.93, 95% CI 1.08-7.93, P = 0.03) were identified as independent predictors of SBE. Patients with SBE had higher 30-day mortality (20.0% versus 4.0% P = 0.02) and 1-year mortality (40.0% versus 11.1%, P < 0.002). SBE independently predicted 1-year, all-cause mortality (HR 5.88, 95% CI 1.7319,94, P = 0.005).SBE are frequent after TAVI and are associated with decreased short and mid-term survival. Diabetes and TS access are independent risk factors for SBE. PMID:26673439

  6. The relationship between IQ, memory, executive function, and processing speed in recent-onset psychosis: 1-year stability and clinical outcome.

    PubMed

    Leeson, Verity C; Barnes, Thomas R E; Harrison, Masuma; Matheson, Elizabeth; Harrison, Isobel; Mutsatsa, Stanley H; Ron, Maria A; Joyce, Eileen M

    2010-03-01

    Studies commonly report poor performance in psychotic patients compared with controls on tasks testing a range of cognitive functions, but, because current IQ is often not matched between these groups, it is difficult to determine whether this represents a generalized deficit or specific abnormalities. Fifty-three first-episode psychosis patients and 53 healthy controls, one-to-one matched for sex, age, and full-scale current IQ, were compared on Wechsler Adult Intelligence Scale (WAIS) subtests representing indices of perceptual organization, verbal comprehension, processing speed, and working memory as well as other tests of executive function and episodic memory. The groups showed an equivalent pattern of performance on all WAIS subtests except digit symbol processing speed, on which the patients were significantly worse. Patients were also worse on measures where performance correlated with digit symbol score, namely working and verbal memory tasks. Standardized residual scores for each subtest were calculated for each patient using the difference between their actual subtest score and a predicted subtest score based on their full-scale IQ and the performance of controls. Scaled scores and residual scores were examined for relationships with clinical measures. Digit symbol-scaled score was significantly correlated with concurrent negative syndrome score at baseline, and digit symbol residual score significantly predicted residual negative symptoms at 1-year follow-up. In summary, our comparison of patients and controls precisely matched for IQ revealed that processing speed was attenuated in recent-onset schizophrenia, contributed significantly to working and episodic memory deficits, and was a prognostic factor for poor outcome at 1 year. PMID:18682375

  7. Clinical characteristics, management and 1-year outcomes of patients with acute coronary syndrome in Iran: the Iranian Project for Assessment of Coronary Events 2 (IPACE2)

    PubMed Central

    Kassaian, Seyed Ebrahim; Masoudkabir, Farzad; Sezavar, Hashem; Mohammadi, Mohammad; Pourmoghaddas, Ali; Kojouri, Javad; Ghaffari, Samad; Sanaati, Hamidreza; Alaeddini, Farshid; Pourmirza, Bahin; Mir, Elham

    2015-01-01

    Objectives To assess contemporary data on characteristics, management and 1-year postdischarge outcomes in Iranian patients hospitalised with acute coronary syndrome (ACS). Setting 11 tertiary care hospitals in 5 major cities in the Islamic Republic of Iran. Participants Patients aged ≥20 and ≤80 years discharged alive with confirmed diagnosis of ACS including ST-segment elevation myocardial infarction (STEMI), non-STEMI (NSTEMI) and high-risk unstable angina (HR-UA). Primary and secondary outcome measures Patients were followed up regarding the use of medications and the end points of the study at 1 month and 1 year after discharge. The primary end point of the study was 1-year postdischarge major adverse cardiac and cerebrovascular events (MACCEs), defined as mortality (cardiac and non-cardiac), ACS and cerebrovascular attack (stroke and/or transient ischaemic attack). The secondary end points were hospital admission because of congestive heart failure, revascularisation by coronary artery bypass grafting surgery or percutaneous coronary intervention (PCI), and major and minor bleeds. Results A total of 1799 patients (25.7% STEMI and 74.3% HR-UA/NSTEMI) discharged alive with confirmed diagnosis of ACS were included in the final analysis. During hospitalisation, the majority of the patients received aspirin (98.6%), clopidogrel (91.8%), anticoagulants (93.4%), statins (94.3%) and β-blockers (89.3%). Reperfusion therapy was performed in 62.6% of patients with STEMI (46.3% thrombolytic therapy and 17.3% primary PCI). The mean door-to-balloon and door-to-needle times were 82.9 and 45.6 min, respectively. In our study, 64.7% and 79.5% of the patients in HR-UA/NSTEMI and STEMI groups, respectively, underwent coronary angiography. During the 12 months after discharge, MACCEs occurred in 15.0% of all patients. Conclusions Our study showed that the composition of Iranian patients with ACS regarding the type of ACS is similar to that in developed European

  8. 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. PMID:10601828

  9. Outcomes observed during a 1-year clinical and radiographic follow-up of patients treated for 1- or 2-level cervical degenerative disease using a biodegradable anterior cervical plate.

    PubMed

    Chen, Mengcun; Yang, Shuhua; Yang, Cao; Xu, Weihua; Ye, Shunan; Wang, Jing; Feng, Yong; Yang, Wen; Liu, Xianzhe

    2016-08-01

    OBJECTIVE The purpose of this study was to present an initial surgical experience in the management of 1- or 2-level degenerative disc disease of the cervical spine using biodegradable anterior cervical plates (bACPs) in anterior cervical discectomy and fusion (ACDF). The authors also aimed to provide insight into this critical and controversial clinical issue by clarifying outcomes for patients receiving bACPs and by comparing their outcomes with those achieved using a traditional metallic anterior cervical plate (mACP) implant. METHODS A retrospective review was conducted for 2 series of patients who had undergone ACDF using either bACP (31 patients, 38 segments) or mACP (47 patients, 57 segments) instrumentation. The patients were followed up for a mean 13.5 ± 0.9 months (range 12-18 months) in the bACP group and 14.8 ± 1.5 months (range 14-22 months) in the mACP group. Clinical outcomes were determined according to scores on the visual analog scale (VAS), the modified Japanese Orthopaedic Association (mJOA) scoring system, and Odom's criteria. Radiological images were used to assess fusion rates, intervertebral height, Cobb's angle, and the width of prevertebral soft tissue. RESULTS Both VAS and mJOA scores were significantly improved at each follow-up in both groups. Excellent or good results according to Odom's criteria were achieved in 93.5% (29/31) of patients in the bACP group and 93.6% (44/47) of patients in the mACP group. At 6 months postoperatively, the fusion rate was 94.7% (36/38) in the bACP group and 96.5% (55/57) in the mACP group, but subsidence of the intervertebral space at the surgical level was more evident in the bACP group. Angulation, as measured by Cobb's angle, demonstrated obvious healing in both groups, while better maintenance was observed in the mACP group. The local inflammatory reaction was uneventful during follow-up. Dysphonia and dysphagia were observed in both groups during the follow-up. CONCLUSIONS The relatively comparable

  10. Diagnosis, Clinical Course, and 1-Year Outcome in Patients Hospitalized for Heart Failure With Preserved Ejection Fraction (from the Polish Cohort of the European Society of Cardiology Heart Failure Long-Term Registry).

    PubMed

    Kapłon-Cieślicka, Agnieszka; Tymińska, Agata; Peller, Michał; Balsam, Paweł; Ozierański, Krzysztof; Galas, Michalina; Marchel, Michał; Crespo-Leiro, Maria G; Maggioni, Aldo Pietro; Drożdż, Jarosław; Filipiak, Krzysztof J; Opolski, Grzegorz

    2016-08-15

    Compared with heart failure (HF) with reduced ejection fraction (HF-REF), the diagnosis of HF with preserved EF (HF-PEF) is more challenging. The aim of the study was to assess the prevalence of HF-PEF among patients hospitalized for HF, to evaluate the pertinence of HF-PEF diagnosis and to compare HF-PEF and HF-REF patients with respect to outcomes. The analysis included 661 Polish patients hospitalized for HF, selected from the European Society of Cardiology (ESC)-HF Long-Term Registry. Patients with an EF of ≥50% were included in the HF-PEF group and patients with an EF of <50% - in the HF-REF group. The primary end point was all-cause death at 1 year. The secondary end point was a composite of all-cause death and rehospitalization for HF at 1 year. HF-PEF was present in 187 patients (28%). Of those 187 patients, mitral inflow pattern was echocardiographically assessed in 116 patients (62%) and classified as restrictive/pseudonormal in 37 patients (20%). Compared with HF-REF subjects, patients with HF-PEF were older, more often female, and had a higher prevalence of hypertension, atrial fibrillation and sleep apnea. Despite lower B-type natriuretic peptide concentrations and lower prevalence of moderate-to-severe mitral regurgitation in patients with HF-PEF, congestive symptoms at admission were as severe as in patients with HF-REF. There were no significant differences in in-hospital mortality between the HF groups. One-year mortality was high in both groups (17% in HF-PEF vs 21% in HF-REF, p = 0.22). There was a trend toward a lower frequency of the secondary end point in the HF-PEF group (32% vs 40%, p = 0.07). In conclusion, in clinical practice, even easily obtainable echocardiographic indexes of diastolic dysfunction are relatively rarely acquired. One-year survival rate of patients with HF-PEF is not significantly better than that of patients with HF-REF. PMID:27374606

  11. Outcomes after thrombus aspiration for ST elevation myocardial infarction: 1-year follow-up of the prospective randomised TOTAL trial

    PubMed Central

    Jolly, Sanjit S; Cairns, John A; Yusuf, Salim; Rokoss, Michael J; Gao, Peggy; Meeks, Brandi; Kedev, Sasko; Stankovic, Goran; Moreno, Raul; Gershlick, Anthony; Chowdhary, Saqib; Lavi, Shahar; Niemela, Kari; Bernat, Ivo; Cantor, Warren J; Cheema, Asim N; Steg, Philippe Gabriel; Welsh, Robert C; Sheth, Tej; Bertrand, Olivier F; Avezum, Alvaro; Bhindi, Ravinay; Natarajan, Madhu K; Horak, David; Leung, Raymond C M; Kassam, Saleem; Rao, Sunil V; El-Omar, Magdi; Mehta, Shamir R; Velianou, James L; Pancholy, Samir; Džavík, Vladimír

    2016-01-01

    Summary Background Two large trials have reported contradictory results at 1 year after thrombus aspiration in ST elevation myocardial infarction (STEMI). In a 1-year follow-up of the largest randomised trial of thrombus aspiration, we aimed to clarify the longer-term benefits, to help guide clinical practice. Methods The trial of routine aspiration ThrOmbecTomy with PCI versus PCI ALone in Patients with STEMI (TOTAL) was a prospective, randomised, investigator-initiated trial of routine manual thrombectomy versus percutaneous coronary intervention (PCI) alone in 10 732 patients with STEMI. Eligible adult patients (aged ≥18 years) from 87 hospitals in 20 countries were enrolled and randomly assigned (1:1) within 12 h of symptom onset to receive routine manual thrombectomy with PCI or PCI alone. Permuted block randomisation (with variable block size) was done by a 24 h computerised central system, and was stratified by centre. Participants and investigators were not masked to treatment assignment. The trial did not show a difference at 180 days in the primary outcome of cardiovascular death, myocardial infarction, cardiogenic shock, or heart failure. However, the results showed improvements in the surrogate outcomes of ST segment resolution and distal embolisation, but whether or not this finding would translate into a longer term benefit remained unclear. In this longer-term follow-up of the TOTAL study, we report the results on the primary outcome (cardiovascular death, myocardial infarction, cardiogenic shock, or heart failure) and secondary outcomes at 1 year. Analyses of the primary outcome were by modified intention to treat and only included patients who underwent index PCI. This trial is registered with ClinicalTrials.gov, number NCT01149044. Findings Between Aug 5, 2010, and July 25, 2014, 10 732 eligible patients were enrolled and randomly assigned to thrombectomy followed by PCI (n=5372) or to PCI alone (n=5360). After exclusions of patients who did not

  12. Subclinical Rejection Phenotypes at 1 Year Post-Transplant and Outcome of Kidney Allografts.

    PubMed

    Loupy, Alexandre; Vernerey, Dewi; Tinel, Claire; Aubert, Olivier; Duong van Huyen, Jean-Paul; Rabant, Marion; Verine, Jérôme; Nochy, Dominique; Empana, Jean-Philippe; Martinez, Frank; Glotz, Denis; Jouven, Xavier; Legendre, Christophe; Lefaucheur, Carmen

    2015-07-01

    Kidney allograft rejection can occur in clinically stable patients, but long-term significance is unknown. We determined whether early recognition of subclinical rejection has long-term consequences for kidney allograft survival in an observational prospective cohort study of 1307 consecutive nonselected patients who underwent ABO-compatible, complement-dependent cytotoxicity-negative crossmatch kidney transplantation in Paris (2000-2010). Participants underwent prospective screening biopsies at 1 year post-transplant, with concurrent evaluations of graft complement deposition and circulating anti-HLA antibodies. The main analysis included 1001 patients. Three distinct groups of patients were identified at the 1-year screening: 727 (73%) patients without rejection, 132 (13%) patients with subclinical T cell-mediated rejection (TCMR), and 142 (14%) patients with subclinical antibody-mediated rejection (ABMR). Patients with subclinical ABMR had the poorest graft survival at 8 years post-transplant (56%) compared with subclinical TCMR (88%) and nonrejection (90%) groups (P<0.001). In a multivariate Cox model, subclinical ABMR at 1 year was independently associated with a 3.5-fold increase in graft loss (95% confidence interval, 2.1 to 5.7) along with eGFR and proteinuria (P<0.001). Subclinical ABMR was associated with more rapid progression to transplant glomerulopathy. Of patients with subclinical TCMR at 1 year, only those who further developed de novo donor-specific antibodies and transplant glomerulopathy showed higher risk of graft loss compared with patients without rejection. Our findings suggest that subclinical TCMR and subclinical ABMR have distinct effects on long-term graft loss. Subclinical ABMR detected at the 1-year screening biopsy carries a prognostic value independent of initial donor-specific antibody status, previous immunologic events, current eGFR, and proteinuria. PMID:25556173

  13. Percutaneous coronary intervention in the elderly: procedural success and 1-year outcomes.

    PubMed

    Eckart, Robert E; Shry, Eric A; Simpson, Daniel E; Stajduhar, Karl C

    2003-01-01

    Clinical trials have found increased morbidity in elderly persons presenting for percutaneous coronary intervention for chronic stable angina. Long-term follow-up is limited for the elderly following percutaneous coronary intervention. The authors reviewed all coronary interventions performed from January 1998 to August 2001. One year following the procedure, subjects were screened for death, need for revascularization, and myocardial infarction. There were 401 subjects aged >/=65 years (mean 73.4+/-6.0 years) and 479 subjects aged <65 years (mean 55.6+/-6.7 years). Although there was no difference in 1-year rate of subsequent myocardial infarction or in revascularization, the elderly were more likely to die during hospitalization (4.7% vs. 1.0%, p<0.01), and at 1 year (10.2% vs. 4.0%, p<0.01). When controlled for ejection fraction, age was no longer significant in either predischarge mortality or in 1-year mortality. Excess postpercutaneous coronary intervention mortality in the elderly may be due to underlying comorbidities and not due to subsequent myocardial infarction or revascularization. PMID:14610387

  14. 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

  15. Infant Aphakia Treatment Study: Effects of persistent fetal vasculature on outcome at 1 year of age

    PubMed Central

    Morrison, David G.; Wilson, M. Edward; Trivedi, Rupal H.; Lambert, Scott R.; Lynn, Michael J.

    2011-01-01

    Background The Infant Aphakia Treatment Study (IATS) is a randomized trial comparing the treatment of unilateral congenital cataract with primary intraocular lens (IOL) implantation versus aphakic contact lens (CL). The purpose of this study was to compare the outcomes for infants with lens opacity associated with persistent fetal vasculature (PFV) to those without. Methods Retrospective subgroup analysis of grating visual acuity at 1 year of age and adverse events up to 1 year after surgery in eyes identified intraoperatively as having evidence of mild PFV from the IATS. Results Of 83 infants, 18 (22%: 11 CL, 7 IOL) had PFV. Median logMAR visual acuity was 0.88 for patients with PFV and 0.80 for patients without PFV (P = 0.46). One or more adverse events up to one year after surgery occurred in 12 infants (67%) with PFV and 30 infants (46%) without PFV (P = 0.18). The incidence of adverse events was significantly higher in patients with PFV compared to patients without PFV in the CL group (55% vs 20%, P = 0.049) but not in the IOL group (86% vs 71%, P = 0.65), possibly because all children receiving IOLs had higher rates of adverse events when compared to aphakic children (73% vs 29%, P < 0.001). Conclusions Aphakic infants with mild PFV treated with CL had a higher incidence of adverse events following lensectomy compared to children with other forms of unilateral congenital cataract; nevertheless, similar visual outcomes at one year after surgery were obtained. PMID:22108353

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

    PubMed

    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 m(2)) 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 m(2) [OR 3.641, 95% CI 1.572-8.433, p < 0.0001], 30-49 ml/min/1.73 m(2) [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

  17. 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. PMID:26373540

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

    PubMed Central

    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.

    2016-01-01

    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. PMID:26373540

  19. Clinical differences between opioid abuse classes ameliorated after 1 year of buprenorphine-medication assisted treatment.

    PubMed

    Tkacz, Joseph; Severt, Jamie; Kassed, Cheryl; Ruetsch, Charles

    2012-01-01

    This study compared the clinical and demographic profiles of three opioid-dependent user groups, and measured their response to 1 year of buprenorphine-medication assisted treatment. Opioid prescription, street, and combination (street + prescription) users completed the Addiction Severity Index multiple times over the course of one treatment year. Although groups differed on all measured demographics (P values <.05) and on six of seven Addiction Severity Index composite scores at induction (P values <.05), differences were ameliorated after 1 year. Findings highlight the disparities between the various opioid-dependent patient subpopulations and suggest that buprenorphine-medication assisted treatment is an effective treatment across user subtypes. PMID:22540432

  20. Outcomes of minimally 1 year follow-up for the arthroscopic Remplissage technique with Hill–Sachs lesion

    PubMed Central

    Ko, Sang-Hun; Shin, Seung-Myeong; Jo, Beom-Geon

    2013-01-01

    Purpose We evaluated minimal 1 year follow-up results for the Remplissage technique to fill a Hill–Sachs lesion with anterior instability. Methods The subjects were 12 patients, who could be followed-up for more than 12 months after the ”Remplissage” procedures in our hospital from August 2008 to May 2010. Their mean age was 28.6 years old and the mean follow-up was 19 months. The evaluations included the ROM, the ASES score, the KSSI score, the ROWE score and postoperative MRI. Results On the postoperative functional evaluation after an average 16 months, the ASES score improved 51.4 in preoperative to 86.6 in postoperatively, the KSSI score improved from 46.6 preoperatively to 84.9 postoperatively and the ROWE score improved from 43.6 preoperatively to 91.4 postoperatively. After an average 14 months for all the cases, the range of movement was nearly in the normal range which is 174.3 ± 5.04 (170–180) degrees in foreward flexion, and 56.4 ± 9.60 (50–60) degrees in external rotation. Conclusion For recurrent shoulder instability with a large Hill–Sachs lesion, the Remplissage technique has a good outcome after more than 1 year follow-up in terms of shoulder stability, and the clinical and functional results. Level of evidence Level IV, therapeutic case series PMID:24403747

  1. 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

  2. Effectiveness of a 1-Year Resident Training Program in Clinical Research: A Controlled Before-and-After Study

    PubMed Central

    Hartmann, Mechthild; Wild, Beate; Nikendei, Christoph; Kroenke, Kurt; Niehoff, Dorothea; Henningsen, Peter; Zipfel, Stephan; Herzog, Wolfgang

    2007-01-01

    Background To increase the number of clinician scientists and to improve research skills, a number of clinical research training programs have been recently established. However, controlled studies assessing their effectiveness are lacking. Objective To investigate the effectiveness of a 1-year resident training program in clinical research. Design Controlled before-and-after study. The training program included a weekly class in clinical research methods, completion of a research project, and mentorship. Participants Intervention subjects were 15 residents participating in the 1-year training program in clinical research. Control subjects were 22 residents not participating in the training program. Measurements and Main Results Assessments were performed at the beginning and end of the program. Outcomes included methodological research knowledge (multiple-choice progress test), self-assessed research competence, progress on publications and grant applications, and evaluation of the program using quantitative and qualitative methods. Results Intervention subjects and controls were well matched with respect to research experience (5.1 ± 2.2 vs 5.6 ± 5.8 years; p = .69). Methodological knowledge improved significantly more in the intervention group compared to the control group (effect size = 2.5; p < .001). Similarly, self-assessed research competence increased significantly more in the intervention group (effect size = 1.1; p = .01). At the end of the program, significantly more intervention subjects compared to controls were currently writing journal articles (87% vs 36%; p = .003). The intervention subjects evaluated the training program as highly valuable for becoming independent researchers. Conclusions A 1-year training program in clinical research can substantially increase research knowledge and productivity. The program design makes it feasible to implement in other academic settings. PMID:17922168

  3. 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

  4. Visual and refractive outcomes of small incision lenticule extraction for the correction of myopia: 1-year follow-up

    PubMed Central

    Kamiya, Kazutaka; Shimizu, Kimiya; Igarashi, Akihito; Kobashi, Hidenaga

    2015-01-01

    Objective To assess the 1 year clinical outcomes of small incision lenticule extraction (SMILE) for the correction of myopia and myopic astigmatism using a 500 kHz femtosecond laser system. Methods This prospective study evaluated 52 eyes of 39 consecutive patients (31.8±6.9 years, mean age±SD) with spherical equivalents of −4.11±1.73 D (range, −1.25 to −8.25 D) who underwent SMILE for myopia and myopic astigmatism. Preoperatively, 1 week, and 1, 3, 6 and 12 months postoperatively, we assessed the safety, efficacy, predictability, stability, corneal endothelial cell loss and the adverse events of the surgery. Results The logarithm of the minimal angle of resolution (logMAR) uncorrected distance visual acuity and LogMAR corrected distance visual acuity were −0.16±0.11 and −0.22±0.07, respectively, 1 year postoperatively. At 1 year, all eyes were within±0.5 D of the targeted correction. Manifest refraction changes of −0.05±0.32 D occurred from 1 week to 1 year postoperatively (p=0.20, Wilcoxon signed-rank test). The endothelial cell density was not significantly changed from 2804±267 cells/mm2 preoperatively to 2743±308 cells/mm2 1 year postoperatively (p=0.12). No vision-threatening complications occurred during the observation period. Conclusions SMILE performed well in the correction of myopia and myopic astigmatism, and no significant change in endothelial cell density or any other serious complications occurred throughout the 1-year follow-up period, suggesting its viability as a surgical option for the treatment of such eyes. PMID:26610755

  5. 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. PMID:23647355

  6. A comparison of 1-year substance abuse treatment outcomes in community syringe exchange participants versus other referrals.

    PubMed

    Neufeld, Karin; King, Van; Peirce, Jessica; Kolodner, Ken; Brooner, Robert; Kidorf, Michael

    2008-09-01

    This longitudinal cohort study of 324 consecutive admissions to methadone maintenance treatment between 08/1994 and 09/1997 compared 1-year outcomes of opioid-dependent patients referred from a syringe exchange program (SEP; n=81) versus other sources (n=243). All participants received stepped-based counseling. The Addiction Severity Index was completed upon admission. Treatment outcomes were assessed using weekly urine testing and days in treatment. GEE regression models were used to evaluate the association between baseline variables and treatment outcomes. SEP referrals were older, included more males and African Americans, reported greater unemployment and heavier heroin, cocaine, and injection drug use at admission. During treatment, SEP referrals used more opioids (OR 2.57; 95% CI 1.86-3.56) and cocaine (OR 2.77; 95% CI 1.93-3.95), and were less likely to complete 1 year (35%) compared to other referrals (56%; hazard ratio 1.88; 95% CI 1.35-2.62). Nevertheless, referral source was not significantly associated with outcome when adjusted for baseline characteristics. Greater baseline frequency of substance and injection drug use, and younger age were positively associated with ongoing opioid and cocaine use. African American race and baseline unemployment were also associated with ongoing cocaine use. Younger age and greater baseline cocaine use were associated with poorer retention at 1 year. The poorer treatment response of SEP referrals is likely due to higher baseline problem severity. Specialized interventions may be required to reduce drug use and improve retention in this population. PMID:18486360

  7. Effectiveness of sealing active proximal caries lesions with an adhesive system: 1-year clinical evaluation.

    PubMed

    Abuchaim, Clarisse; Rotta, Marina; Grande, Rosa Helena Miranda; Loguercio, Alessandro Dourado; Reis, Alessandra

    2010-01-01

    The objective of this study was to evaluate the effectiveness of a therapeutic sealant to arrest non-cavitated proximal carious lesion progression. The study population comprised 44 adolescents who had bitewing radiographs taken for caries diagnosis. Non-cavitated lesions extending up to half of dentin thickness were included in the sample. In the experimental group (n = 33), the proximal caries-lesion surfaces were sealed with an adhesive (OptiBond Solo, Kerr) after tooth separation. The control group (n = 11) received no treatment, except for oral hygiene instructions including use of dental floss. Follow-up radiographs were taken after one year and were analyzed in comparison with baseline radiographs. In a blind study setting, visual readings were performed by two examiners, blinded to whether the examined radiograph was baseline or follow-up, and whether it concerned a test or control lesion. The efficacy of sealing treatment was evaluated by the McNemar test (0.05). About 22% of the sealed lesions showed reduction, 61% showed no change and 16% showed progression. For the control lesions, the corresponding values were 27%, 36% and 36% respectively. The number of lesions that showed reduction and no changes were merged and therefore 83.3% of the sealed lesions and 63.6% of the control lesions were considered clinically successful. No statistical significance was detected (p > 0.05). In the course of 1 year, sealing proximal caries lesions was not shown to be superior to lesion monitoring. PMID:20877976

  8. 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. PMID:26032461

  9. Long-Term Predictors of Clinical Events after Off-Label Use of Drug-Eluting Stent beyond 1 Year

    PubMed Central

    Ko, Jum Suk; Rhee, Sang Jae; Lee, Eun Mi; Yoo, Nam Jin; Kim, Nam-Ho; Oh, Seok Kyu; Jeong, Jin-Won

    2013-01-01

    Background and Objectives We evaluated the long-term outcomes and predictors of clinical events after off-label use of drug-eluting stents (DES) beyond 1 year after procedure. Subjects and Methods A total of 518 patients who underwent DES implantation for off-label indications and did not have any major adverse cardiac events (MACE) during the first year were analyzed. The occurrence of MACE, including cardiac death, myocardial infarction (MI), stent thrombosis and target vessel revascularization, were evaluated for a median 1179 days (interquartile range 769-1541) after the first year. Results Major adverse cardiac events occurred in 43 patients (8.3%) including 8 cases (1.5%) of cardiac death, 9 cases (1.7%) of MI, 24 cases (4.6%) of target vessel revascularization, and 11 cases (2.1%) of stent thrombosis. Patients with MACE had a higher serum creatinine level, higher incidence of in-stent restenosis lesion, more overlapping stents, a greater number of stents, and longer stents than did patients without MACE. Multivariate analysis revealed that serum creatinine level >1.5 mg/dL {hazard ratio (HR) 2.3, p=0.019}, stent length >33 mm (HR 2.4, p=0.035), and in-stent restenosis lesions (HR 2.4, p=0.040) were independent risk factors for MACE. Patients with DES length >33 mm had a higher incidence of MACE than those with DES length ≤33 mm (HR 2.7, log rank p=0.002). Conclusion The risk of stent thrombosis and target vessel revascularization persisted in patients undergoing off-label DES implantation beyond 1-year follow-up. A total DES length >33 mm was a significant procedural predictor associated with the incidence of MACE. PMID:23613692

  10. 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

  11. 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. PMID:22622598

  12. Comparison of Angiographic and 1-Year Outcomes Between a Long Single Stent and Overlapping Double Stents in Patients With Newer-Generation Drug-Eluting Stents for Long Narrowings.

    PubMed

    Mori, Naoki; Okamoto, Naotaka; Tanaka, Akihiro; Yano, Masamichi; Makino, Nobuhiko; Egami, Yasuyuki; Shutta, Ryu; Sakata, Yasushi; Tanouchi, Jun; Nishino, Masami

    2016-06-01

    Although some clinical studies have revealed adverse clinical and angiographic outcomes of early-generation overlapping drug-eluting stents (DES), the safety and efficacy of overlapping newer-generation DES for long narrowings have not been well established. This study aimed to compare angiographic and 1-year clinical outcomes between a long single stent (LSS) and overlapping double stents (ODS) in patients treated with newer-generation DES for similarly long narrowings. We analyzed 8 to 10 months angiographic and 1-year clinical outcomes of 112 lesions of 105 patients with long (30 to 38 mm) narrowings treated with everolimus-eluting stent, a newer-generation DES, using LSS or ODS. We divided our patients into LSS group (46 patients with 49 lesions) and ODS group (59 patients with 63 lesions). As a result, the rates of freedom from major adverse cardiac events (92.9% vs 93.1%, p = 0.91) and target lesion revascularization (94.5% vs 95.1%, p = 0.79) during 1-year follow-up were similar between the 2 groups. There was no stent thrombosis observed between the 2 groups. In conclusion, everolimus-eluting stent provided similar angiographic and 1-year clinical outcomes regardless of overlap status in long narrowings. PMID:27062939

  13. 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. PMID:24904179

  14. 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.

  15. 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

  16. 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…

  17. Endoscopic ultrasonic dacryocystorhinostomy: clinical profile and outcomes.

    PubMed

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

    2016-07-01

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

  18. Clinical guidelines and management of ankyloglossia with 1-year followup: report of 3 cases.

    PubMed

    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

  19. 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

  20. Reference Intervals of Hematology and Clinical Chemistry Analytes for 1-Year-Old Korean Children

    PubMed Central

    Lee, Hye Ryun; Roh, Eun Youn; Chang, Ju Young

    2016-01-01

    Background Reference intervals need to be established according to age. We established reference intervals of hematology and chemistry from community-based healthy 1-yr-old children and analyzed their iron status according to the feeding methods during the first six months after birth. Methods A total of 887 children who received a medical check-up between 2010 and 2014 at Boramae Hospital (Seoul, Korea) were enrolled. A total of 534 children (247 boys and 287 girls) were enrolled as reference individuals after the exclusion of data obtained from children with suspected iron deficiency. Hematology and clinical chemistry analytes were measured, and the reference value of each analyte was estimated by using parametric (mean±2 SD) or nonparametric methods (2.5-97.5th percentile). Iron, total iron-binding capacity, and ferritin were measured, and transferrin saturation was calculated. Results As there were no differences in the mean values between boys and girls, we established the reference intervals for 1-yr-old children regardless of sex. The analysis of serum iron status according to feeding methods during the first six months revealed higher iron, ferritin, and transferrin saturation levels in children exclusively or mainly fed formula than in children exclusively or mainly fed breast milk. Conclusions We established reference intervals of hematology and clinical chemistry analytes from community-based healthy children at one year of age. These reference intervals will be useful for interpreting results of medical check-ups at one year of age. PMID:27374715

  1. A randomized double-blind clinical trial of posterior composite restorations with or without bevel: 1-year follow-up

    PubMed Central

    COELHO-DE-SOUZA, Fábio Herrmann; CAMARGO, Junara Cristina; BESKOW, Tiago; BALESTRIN, Matheus Dalmolin; KLEIN-JÚNIOR, Celso Afonso; DEMARCO, Flávio Fernando

    2012-01-01

    Objective This randomized double-blind clinical trial compared the performance of posterior composite restorations with or without bevel, after 1-year follow-up. Material and Methods Thirteen volunteers requiring at least two posterior composite restorations were selected. Twenty-nine cavities were performed, comprising 14 without bevel (butt joint) and 15 with bevel preparation of the enamel cavosurface angle. All cavities were restored with simplified adhesive system (Adper Single Bond) and composite resin (Filtek P60). A halogen light curing unit was used through the study. Restorations were polished immediately. Analysis was carried out at baseline, after 6 months and after 1 year by a calibrated evaluator (Kappa), according to the FDI criteria. Data were statistically analyzed by Mann-Whitney test (p<0.05). Results Beveled and non-beveled cavities performed similarly after 1 year follow-up, regarding to fractures and retention, marginal adaptation, postoperative hypersensitivity, recurrence of caries, surface luster and anatomic form. However, for surface and marginal staining, beveled cavities showed significantly better performance (p<0.05) than butt joint restorations. Conclusions It was concluded that the restorations were acceptable after 1 year, but restorations placed in cavities with marginal beveling showed less marginal staining than those placed in non-beveled cavities. PMID:22666833

  2. Clinical outcome of daily dialysis.

    PubMed

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

    2001-01-01

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

  3. Outcome Prediction in Clinical Treatment Processes.

    PubMed

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

    2016-01-01

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

  4. Factors of Hamilton Depression Rating Scale (17 items) at 2 weeks correlated with poor outcome at 1 year in patients with ischemic stroke.

    PubMed

    Yuan, Huaiwu; Zhang, Ning; Wang, Chunxue; Luo, Ben Yan; Shi, Yuzhi; Li, Jingjing; Zhou, Yong; Wang, Yilong; Zhang, Tong; Zhou, Juan; Zhao, Xingquan; Wang, Yongjun

    2014-02-01

    There was fewer paper about the relation between the Hamilton Depression Rating Scale (17 Items, HDRS-17) factors and stroke outcomes. Our aim was to investigate the influence of total score and factors of HDRS-17 on outcome of ischemic stroke at 1 year. A total of 1,953 patients with acute ischemic stroke were enrolled into a multicentered and prospective cohort study. The HDRS-17 was used to assess symptoms at 2 weeks after ischemic stroke. The Modified Ranking Scale (mRS) scores of 3-6 points and 0-2 points were regarded as poor outcome and benign outcome, respectively. At 1 year, 1,753 (89.8 %) patients had mRS score data. After adjusting for the confounders, patients with a total HDRS-17 score of ≥ 8 had a worse outcome at 1 year (OR = 1.62, 95 % CI 1.18-2.23). Symptoms of suicide (OR = 1.89, 95 % CI 1.27-2.83), decreased or loss of interest of work (OR = 1.89, 95 % CI 1.38-2.58), retardation (OR = 1.74, 95 % CI 1.27-2.38), psychic anxiety (OR = 1.72, 95 % CI 1.26-2.34), and agitation (OR = 1.61, 95 % CI 1.08-2.40) increased the risks for poor outcome by >60 %, respectively. Depressed mood, somatic anxiety, somatic symptoms-gastrointestinal, and early insomnia also increased the risk for poor outcome by nearly 50 %, respectively. A total HDRS-17 score of ≥ 8, and suicide, decreased or loss of interest of work, anxiety, agitation, retardation, depressed mood, somatic anxiety, somatic symptoms-gastrointestinal, and early insomnia of the HDRS-17 factors at 2 weeks after ischemic stroke increase the risk for poor outcome at 1 year. PMID:23715751

  5. 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

  6. A 1-year Aspergillus terreus surveillance study at the University Hospital of Innsbruck: molecular typing of environmental and clinical isolates.

    PubMed

    Blum, G; Perkhofer, S; Grif, K; Mayr, A; Kropshofer, G; Nachbaur, D; Kafka-Ritsch, R; Dierich, M P; Lass-Flörl, C

    2008-12-01

    Aspergillus terreus appears to have become an increasingly frequent cause of opportunistic infections in the University Hospital of Innsbruck (UHI) and is of serious concern because of in vivo and in vitro resistance to amphotericin B. In order to determine the possible relationship between environmental contamination by A. terreus and the occurrence of invasive aspergillosis, a 1-year prospective study (2004-2005) was carried out in the UHI. Isolates obtained from air samples of various high-risk settings and those from surveillance cultures of proven and probable aspergillosis (EORTC/MSG criteria) were examined by genotyping. Within 1 year, 34 and 15 A. terreus isolates were collected from the environment and from patients, respectively. Genotypic analysis with rapid amplification of polymorphic DNA (RAPD) PCR and the combination of three different primers (R108, CII, P4) revealed 46 distinct genotypic profiles (types 1-46). No strain similarity was detected among and within the patients and environmental areas, indicating a great genomic diversity in A. terreus, which is common in the environment of Innsbruck and a source of invasive infections in immunosuppressed patients. Genotypical diversity was found in clinical and environmental A. terreus isolates. PMID:19076844

  7. Trajectories of Depressive Symptomatology in Rural Memory Clinic Patients between Baseline Diagnosis and 1-Year Follow-Up

    PubMed Central

    Kosteniuk, Julie G.; Morgan, Debra G.; O'Connell, Megan E.; Kirk, Andrew; Crossley, Margaret; Stewart, Norma J.; Karunanayake, Chandima P.

    2016-01-01

    Background/Aims To investigate the prevalence and trajectories of depressive symptomatology at 1-year follow-up, and the severity of depressive symptoms, by dementia diagnostic group, as well as to determine the predictors of depressive symptomatology at 1-year follow-up. Methods In rural and remote patients of an interdisciplinary memory clinic between 2004 and 2014, 144 patients diagnosed with no cognitive impairment (NCI), mild cognitive impairment, dementia due to Alzheimer's disease (AD), or non-AD dementia completed the Center for Epidemiologic Studies of Depression Scale to assess depressive symptomatology at both time points. Results Among patients with data at both time points, persistence of depressive symptomatology at follow-up occurred in 22.2%, remission in 17.4%, incidence in 13.2%, and absence in 47.2%. The prevalence of depressive symptomatology at baseline and persistence at follow-up were significantly greater in the NCI group than in the other diagnostic groups, but there were no differences in severity. Depressive symptomatology at follow-up was independently associated with depressive symptomatology, lower independence in activities of daily living, and lower self-rating of memory at baseline, as well as with decreased independence in activities of daily living between time points. Conclusion Future studies should further examine short-term postdiagnostic trajectories in depressive symptomatology in multiple dementia diagnostic groups to inform prognoses and treatment decisions. PMID:27350776

  8. 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

  9. Outcome instruments for prosthetics: clinical applications.

    PubMed

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

    2014-02-01

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

  10. 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…

  11. Clinical Outcomes of Characterized Chondrocyte Implantation

    PubMed Central

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

    2012-01-01

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

  12. The biologic stability of alumina-zirconia implant abutments after 1 year of clinical service: a digital subtraction radiographic evaluation.

    PubMed

    Bae, Kyu-Hyun; Han, Jung-Suk; Seol, Yang-Jo; Butz, Frank; Caton, Jack; Rhyu, In-Chul

    2008-04-01

    The purpose of the present clinical study was to evaluate the biologic stability of alumina-zirconia implant abutments by histologic and radiographic examination. Nineteen partially edentulous patients were treated with 37 external-hexagon implants. After a healing period of 3 to 6 months, alumina-zirconia abutments were connected and restored with cemented single crowns or short-span fixed partial dentures. Periapical radiographs were taken at the time of prosthesis delivery and after 3, 6, and 12 months of follow-up. Crestal alveolar bone level changes were assessed by digital subtraction of consecutive images, and 1-way analysis of variance was used for statistical analysis. No implant, abutment, or restoration failed during the observation period. Bone level changes were statistically insignificant and histologic examination revealed no signs of inflammation. Stable and healthy soft and hard tissue conditions may be expected around alumina-zirconia abutments after 1 year of clinical service. However, long-term data are needed to confirm the present results. PMID:18546809

  13. Predicting Clinical Outcomes Using Molecular Biomarkers

    PubMed Central

    Burke, Harry B.

    2016-01-01

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

  14. Does cognitive impairment influence outcomes from cataract surgery? Results from a 1-year follow-up cohort study

    PubMed Central

    Jefferis, Joanna Mary; Taylor, John-Paul; Clarke, Michael Patrick

    2015-01-01

    Background/aims To assess the impact of impaired cognition on visual outcomes 1 year following cataract surgery in a cohort of older people. Methods Participants aged 75 years or more with bilateral cataract and scheduled for cataract surgery were recruited consecutively. Cognition was assessed using the revised Addenbrooke's cognitive examination (ACE-R). Participants were divided into two groups: normal (ACE-R ≥88) and impaired cognition (ACE-R <88). Visual quality of life (VQOL) and logarithm of minimum angle of resolution visual acuity (VA) were assessed at baseline and 1 year following cataract surgery. Results Of 112 participants, 48 (43%) had normal cognition and 64 (57%) had impaired cognition. One year following cataract surgery participants in both groups had significant improvements in VQOL and VA. Visual outcomes at 1 year were significantly better in participants with normal cognition than in those with impaired cognition (95% CIs for difference 0.4–7.0 and 0.02–0.1, for VQOL and VA, respectively). Regression analyses correcting for potential confounders showed a relationship between baseline cognition and VA at 1 year (R2=0.30, p=0.001) and a possible relationship between baseline cognition and VQOL at 1 year (R2=0.41, p=0.01, this became insignificant after removal of outliers). Conclusions Patients with impaired cognition benefit from cataract surgery, but not to the same extent as patients with normal cognition. PMID:25287367

  15. Clinical and fiscal outcomes of utilization review.

    PubMed

    Murray, Mary Ellen; Darmody, Julie V

    2004-01-01

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

  16. Endoscopic minimally invasive transforaminal interbody fusion without general anesthesia: initial clinical experience with 1-year follow-up.

    PubMed

    Wang, Michael Y; Grossman, Jay

    2016-02-01

    OBJECTIVE One of the principal goals of minimally invasive surgery has been to speed postoperative recovery. In this case series, the authors used an endoscopic technique for interbody fusion combined with percutaneous screw fixation to obviate the need for general anesthesia. METHODS The first 10 consecutive patients treated with a minimum of 1 year's follow-up were included in this series. The patients were all treated using endoscopic access through Kambin's triangle to allow for neural decompression, discectomy, endplate preparation, and interbody fusion. This was followed by percutaneous pedicle screw and connecting rod placement using liposomal bupivacaine for long-acting analgesia. No narcotics or regional anesthetics were used during surgery. RESULTS All patients underwent the procedure successfully without conversion to open surgery. The patients' average age was 62.2 ± 9.0 years (range 52-78 years). All patients had severe disc height collapse, and 60% had a Grade I spondylolisthesis. The mean operative time was 113.5 ± 6.3 minutes (range 105-120 minutes), and blood loss was 65 ± 38 ml (range 30-190 ml). The mean length of hospital stay was 1.4 ± 1.3 nights. There were no intraoperative or postoperative complications. Comparison of preoperative and final clinical metrics demonstrated that the Oswestry Disability Index improved from 42 ± 11.8 to 13.3 ± 15.1; the 36-Item Short Form Health Survey (SF-36) Physical Component Summary improved from 47.6 ± 3.8 to 49.7 ± 5.4; the SF-36 Mental Component Summary decreased from 47 ± 3.9 to 46.7 ± 3.4; and the EQ-5D improved from 10.7 ± 9.5 to 14.2 ± 1.6. There were no cases of nonunion identified radiographically on follow-up imaging. CONCLUSIONS Endoscopic fusion under conscious sedation may represent a feasible alternative to traditional lumbar spine fusion in select patients. Larger clinical series are necessary to validate that clinical improvements are sustained and that arthrodesis rates are

  17. Clinical outcome measures for Cutaneous Lupus Erythematosus

    PubMed Central

    Albrecht, Joerg; Werth, Victoria P.

    2011-01-01

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

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

    PubMed

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

    2015-08-01

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

  19. Clinical predictors of outcome in encephalitis.

    PubMed Central

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

    1987-01-01

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

  20. Impact on Left Ventricular Function and Remodeling and on 1-Year Outcome in Patients With Left Bundle Branch Block After Transcatheter Aortic Valve Implantation.

    PubMed

    Carrabba, Nazario; Valenti, Renato; Migliorini, Angela; Marrani, Marco; Cantini, Giulia; Parodi, Guido; Dovellini, Emilio Vincenzo; Antoniucci, David

    2015-07-01

    Conflicting results have been reported about the prognostic impact of left bundle branch block (LBBB) after transcatheter aortic valve implantation (TAVI). The aim of this study was to evaluate the impact of LBBB after TAVI on left ventricular (LV) function and remodeling and on 1-year outcomes. Of 101 TAVI patients, 9 were excluded. All complications were evaluated according to the Valve Academic Research Consortium 2 definition. Of 92 patients, 34 developed LBBB without more advanced myocardial damage or inflammation biomarkers in comparison with patients without LBBB. The only predictor of new LBBB was larger baseline LV end-diastolic volume. LBBB plus advanced atrioventricular block was strongly correlated with permanent pacemaker implantation (p <0.0001). Patients with LBBB had a higher rate of permanent pacemaker implantation at 30 days (59% vs 19%, p <0.0001) and less recovery of LV systolic function and a trend toward a lower rate of LV reverse remodeling at 1 year. The development of acute kidney injury and the logistic European System for Cardiac Operative Risk Evaluation score were associated with poor outcomes (all-cause mortality and heart failure) (hazard ratio 6.86, 95% confidence interval 2.51 to 18.74, p <0.0001, and hazard ratio 1.04, 95% confidence interval 1.01 to 1.08, p = 0.021, respectively), but not LBBB. In conclusion, after TAVI, 37% of patients developed new LBBB without more advanced myocardial damage or inflammation biomarkers. LBBB was associated with a higher rate of permanent pacemaker implantation, which negatively affected the recovery of LV systolic function. The development of acute kidney injury, rather than LBBB, increases the 1-year risk for mortality and hospitalization for heart failure. PMID:25937352

  1. Clinical Outcomes after Traumatic Brain Injury.

    PubMed

    Sandsmark, Danielle K

    2016-06-01

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

  2. Clinical Outcomes After Anterior Cruciate Ligament Reconstruction

    PubMed Central

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

    2010-01-01

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

  3. 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

  4. 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

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

    PubMed

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

    2016-03-01

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

  6. Frequency of abnormal findings detected by comprehensive clinical evaluation at 1 year after allogeneic hematopoietic cell transplantation.

    PubMed

    Lee, Stephanie J; Seaborn, Travis; Mao, Frances J; Massey, Susan C; Luu, Ngoc Q; Schubert, Mary A; Chien, Jason W; Carpenter, Paul A; Moravec, Carina; Martin, Paul J; Flowers, Mary E D

    2009-04-01

    Consensus guidelines recommend various screening examinations for survivors after allogeneic hematopoietic cell transplantation (HCT), but how often these examinations detect abnormal findings is unknown. We reviewed the medical records of 118 patients who received comprehensive, standardized evaluations at 1 year after allogeneic HCT at Fred Hutchinson Cancer Research Center/Seattle Cancer Care Alliance. Abnormal findings were common, including moderate to severe pulmonary dysfunction (16%), fasting hyperlipidemia (56%), osteopenia (52%), osteoporosis (6%), and active chronic graft-versus-host disease (cGVHD) (64%). Recurrent malignancy (4%) and cGVHD (29%) were detected in previously unsuspected cases. Only 3% of patients had no abnormal findings. We conclude that comprehensive evaluation at 1 year after allogeneic HCT detects a high prevalence of medical problems. Longer follow-up is needed to determine whether early detection and intervention affect later morbidity and mortality. PMID:19285628

  7. Impact of Remote Monitoring on Clinical Outcomes.

    PubMed

    Varma, Niraj; Ricci, Renato Pietro

    2015-12-01

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

  8. Pediatric multiple sclerosis: Clinical features and outcome.

    PubMed

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

    2016-08-30

    Multiple sclerosis (MS) in children manifests with a relapsing-remitting MS (RRMS) disease course. Acute relapses consist of new neurologic deficits persisting greater than 24 hours, in the absence of intercurrent illness, and occur with a higher frequency early in the disease as compared to adult-onset RRMS. Most pediatric patients with MS recover well from these early relapses, and cumulative physical disability is rare in the first 10 years of disease. Brainstem attacks, poor recovery from a single attack, and a higher frequency of attacks portend a greater likelihood of future disability. Although prospective pediatric-onset MS cohorts have been established in recent years, there remains very limited prospective data detailing the longer-term clinical outcome of pediatric-onset MS into adulthood. Whether the advent of MS therapies, and the largely off-label access to such therapies in pediatric MS, has improved prognosis is unknown. MS onset during the key formative academic years, concurrent with active cognitive maturation, is an important determinant of long-term outcome, and is discussed in detail in another article in this supplement. Finally, increasing recognition of pediatric MS worldwide, recent launch of phase III trials for new agents in the pediatric MS population, and the clear imperative to more fully appreciate health-related quality of life in pediatric MS through adulthood highlight the need for standardized, validated, and robust outcome measures. PMID:27572865

  9. Clinical outcomes of acute myocarditis in childhood

    PubMed Central

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

    1999-01-01

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


Keywords: myocarditis; paediatric cardiology; immunosuppression PMID:10409542

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

    PubMed Central

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

    2016-01-01

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

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

    PubMed Central

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

    2016-01-01

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

  12. AlphaCor artificial cornea: clinical outcome

    PubMed Central

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

    2011-01-01

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

  13. Clinical characteristics and outcomes in biclonal gammopathies.

    PubMed

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

    2016-05-01

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

  14. 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

  15. Controlled outcome studies of child clinical hypnosis.

    PubMed

    Adinolfi, Barbara; Gava, Nicoletta

    2013-08-01

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

  16. The National Anesthesia Clinical Outcomes Registry.

    PubMed

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

    2015-12-01

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

  17. [A case of lyme disease requiring over 1 year to diagnose at an infectious-disease clinic].

    PubMed

    Iwata, Kentaro; Shimada, Tomoe; Kawabata, Hiroki

    2013-01-01

    A 42-year-old woman presenting with years of fever and vague symptoms could not be satisfactorily diagnosed in physical examination or conventional workups. She was presumptively diagnosed with chronic fatigue syndrome and treated symptomatically. Fourteen months after the initial visit, she developed left facial palsy. Lyme disease serology was positive. Four weeks of oral amoxicillin ameliorated symptoms. Only 5 to 15 cases of Lyme disease are reported annually in Japan, mostly from the northeastern-most island of Hokkaido. It may occur anywhere in Japan, however; probably is underdiagnosed. Lyme disease may cause fevers of unknown origin. Astute clinical suspicion and appropriate workups are thus needed to diagnose this infection. PMID:23484378

  18. Reduction of pain and fracture incidence after kyphoplasty: 1-year outcomes of a prospective controlled trial of patients with primary osteoporosis.

    PubMed

    Grafe, Ingo A; Da Fonseca, Katharina; Hillmeier, Jochen; Meeder, Peter-Jürgen; Libicher, Martin; Nöldge, Gerd; Bardenheuer, Hubert; Pyerin, Walter; Basler, Linus; Weiss, Christel; Taylor, Rod S; Nawroth, Peter; Kasperk, Christian

    2005-12-01

    Previously, we reported significantly reduced pain and improved mobility persisting for 6 months after kyphoplasty of chronically painful osteoporotic vertebral fractures in the first prospective controlled trial. Since improvement of spinal biomechanics by restoration of vertebral morphology may affect the incidence of fracture, long-term clinical benefit and thereby cost-effectiveness, here we extend our previous work to assess occurrence of new vertebral fractures and clinical parameters 1 year after kyphoplasty compared with a conservatively treated control group. Sixty patients with osteoporotic vertebral fractures due to primary osteoporosis were included: 40 patients were treated with kyphoplasty, 20 served as controls. All patients received standard medical treatment. Morphological characteristics, new vertebral fractures, pain (visual analog scale), physical function [European Vertebral Osteoporosis Study (EVOS) score] (range 0-100 each) and back-pain-related doctors' visits were re-assessed 12 months after kyphoplasty. There were significantly fewer patients with new vertebral fractures of the thoracic and lumbar spine, after 12-months, in the kyphoplasty group than in the control group (P=0.0084). Pain scores improved from 26.2 to 44.4 in the kyphoplasty group and changed from 33.6 to 34.3 in the control group (P=0.008). Kyphoplasty treated patients required a mean of 5.3 back-pain-related doctors' visits per patient compared with 11.6 in the control group during 12 months follow-up (P=0.006). Kyphoplasty as an addition to medical treatment and when performed in appropriately selected patients by an interdisciplinary team persistently improves pain and reduces occurrence of new vertebral fractures and healthcare utilization for at least 12 months in individuals with primary osteoporosis. PMID:16078092

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

    PubMed

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

    2015-10-01

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

  20. Urgent discectomy: Clinical features and neurological outcome

    PubMed Central

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

    2016-01-01

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

  1. Cervical Scoliosis: Clinical and Radiographic Outcomes.

    PubMed

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

    2016-02-01

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

  2. Cervical Scoliosis: Clinical and Radiographic Outcomes

    PubMed Central

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

    2015-01-01

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

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

    PubMed

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

    2015-01-01

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

  4. Outcomes of a 1-year randomized controlled trial to evaluate a behavioral ‘stepped-down’ weight loss intervention for adolescent patients with obesity

    PubMed Central

    Norman, G.; Huang, J.; Davila, E. P.; Kolodziejczyk, J. K.; Carlson, J.; Covin, J. R.; Gootschalk, M.; Patrick, K.

    2015-01-01

    Summary Background Stepped-care approaches to weight loss have shown some success among adults. A ‘stepped-down’ version of the stepped-care approach to adolescent weight loss has never been evaluated. Objectives We conducted a one-year randomized controlled trial to compare a stepped-down weight loss intervention versus enhanced usual care (EUC). Methods Study participants were obese adolescents age 11–13 (N = 106, 51% girls, and 82% Hispanic) recruited from primary care clinics in San Diego, California. The stepped-down intervention was delivered through clinician and health educator counseling (in-person and by phone) and mailed content. The intervention consisted of four-month ‘steps’ beginning with the most intensive contact followed by reduced contact if treatment goals were met. The EUC group received an initial physician visit, one session with a health counselor, and monthly mailed materials. Body mass index (BMI kg/m2) was measured at baseline, 4, 8, and 12 months. Mixed-model regression analyses were stratified by sex. Results Results indicated a clinically significant treatment effect for boys on BMI (p < 0.001) but not girls. No between group differences were found for adiposity and biometric outcomes. Only 13% of intervention participants succeeded in stepping down from step 1 to step 2 or step 3. Conclusions A stepped-down approach to weight loss showed some evidence of efficacy for weight loss in boys but not girls. The findings suggest the program as designed was not intensive enough to result in weight loss in this population segment. PMID:25702630

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

    PubMed

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

    2011-06-01

    This study examines the distribution of health outcomes research (HOR) studies in the clinical literature by clinical areas and journal impact factor. The authors reviewed 535 journals and divided the sample into higher and lower impact journals across four clinical area. Mann-Whitney and Kruskal-Wallis tests were used to examine differences across four categories of outcomes research articles published, specifically the incidence of articles in higher versus lower impact journals and differences across clinical areas. All high-impact journals published more safety and quality articles than process assessment, quality of life, or cost analysis studies. The number of each type of outcomes research study published was highly variable across all clinical areas. Only arthritis and outcomes research journals showed statistically significant differences between higher versus lower impact journals. Authors may benefit from considering these differences in their clinical specialty area when deciding where to submit HOR studies. PMID:21411472

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

    PubMed

    Mochtar, I; Al-Monjed, M F

    2015-04-01

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

  7. 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.

  8. Evaluation of nonlinear frequency compression: Clinical outcomes

    PubMed Central

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

    2009-01-01

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

  9. 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…

  10. 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

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

    PubMed

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

    2016-07-01

    The outcome of treatment with antidepressants varies markedly across people with the same diagnosis. A clinically significant prediction of outcomes could spare the frustration of trial and error approach and improve the outcomes of major depressive disorder through individualized treatment selection. It is likely that a combination of multiple predictors is needed to achieve such prediction. We used elastic net regularized regression to optimize prediction of symptom improvement and remission during treatment with escitalopram or nortriptyline and to identify contributing predictors from a range of demographic and clinical variables in 793 adults with major depressive disorder. A combination of demographic and clinical variables, with strong contributions from symptoms of depressed mood, reduced interest, decreased activity, indecisiveness, pessimism and anxiety significantly predicted treatment outcomes, explaining 5-10% of variance in symptom improvement with escitalopram. Similar combinations of variables predicted remission with area under the curve 0.72, explaining approximately 15% of variance (pseudo R(2)) in who achieves remission, with strong contributions from body mass index, appetite, interest-activity symptom dimension and anxious-somatizing depression subtype. Escitalopram-specific outcome prediction was more accurate than generic outcome prediction, and reached effect sizes that were near or above a previously established benchmark for clinical significance. Outcome prediction on the nortriptyline arm did not significantly differ from chance. These results suggest that easily obtained demographic and clinical variables can predict therapeutic response to escitalopram with clinically meaningful accuracy, suggesting a potential for individualized prescription of this antidepressant drug. PMID:27089522

  12. 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.

  13. 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…

  14. 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%.

  15. Single Case Research Results as Clinical Outcomes

    ERIC Educational Resources Information Center

    Parker, Richard I.; Hagan-Burke, Shanna

    2007-01-01

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

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

    PubMed

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

    2014-12-01

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

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

    ERIC Educational Resources Information Center

    Robey, Randall R.

    2004-01-01

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

  18. 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

  19. Functional outcomes for clinical evaluation of implant restorations.

    PubMed

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

    2013-01-01

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

  20. Nutrition and Chronic Wounds: Improving Clinical Outcomes.

    PubMed

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

    2016-09-01

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

  1. Mediators, Moderators, and Predictors of 1-Year Outcomes Among Children Treated for Early-Onset Conduct Problems: A Latent Growth Curve Analysis

    ERIC Educational Resources Information Center

    Beauchaine, Theodore P.; Webster-Stratton, Carolyn; Reid, M. Jamila

    2006-01-01

    Several child conduct problem interventions have been classified as either efficacious or well established. Nevertheless, much remains to be learned about predictors of treatment response and mechanisms of behavioral change. In this study, the authors combine data from 6 randomized clinical trials and 514 children, ages 3.0-8.5 years, to evaluate…

  2. Wrist function recovers more rapidly after volar locked plating than after external fixation but the outcomes are similar after 1 year

    PubMed Central

    2011-01-01

    Background and purpose Promising results have been reported after volar locked plating of unstable dorsally displaced distal radius fractures. We investigated whether volar locked plating results in better patient-perceived, objective functional and radiographic outcomes compared to the less invasive external fixation. Patients and methods 63 patients under 70 years of age, with an unstable extra-articular or non-comminuted intra-articular dorsally displaced distal radius fracture, were randomized to volar locked plating (n = 33) or bridging external fixation. Patient-perceived outcome was assessed with the Disability of the Arm, Shoulder, and Hand (DASH) questionnaire and the Patient-Rated Wrist Evaluation (PRWE) questionnaire. Results At 3 and 6 months, the volar plate group had better DASH and PRWE scores but at 12 months the scores were similar. Objective function, measured as grip strength and range of movement, was superior in the volar plate group but the differences diminished and were small at 12 months. Axial length and volar tilt were retained slightly better in the volar plate group. Interpretation Volar plate fixation is more advantageous than external fixation, in the early rehabilitation period. PMID:21281262

  3. Bioplastique at 6 years: clinical outcome studies.

    PubMed

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

    1997-11-01

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

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

    PubMed

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

    2016-01-01

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

  5. Initial healthcare and coping preferences are associated with outcome 1 year after whiplash trauma: a multicentre 1-year follow-up study

    PubMed Central

    Myrtveit, Solbjørg Makalani; Carstensen, Tina; Kasch, Helge; Ørnbøl, Eva; Frostholm, Lisbeth

    2015-01-01

    Objective Individuals exposed to whiplash collisions have to cope with the stressful event as well as early physical symptoms. As in other chronic pain conditions, coping has been associated with outcome after whiplash. In this study, our aim was to examine whether initial coping preferences were associated with the development of chronic whiplash. Design Prospective study. Setting Primary care. Methods 740 acute whiplash patients were recruited from emergency units and general practitioners after car collisions in Denmark. Within 10 days postinjury, participants were asked what they believed could help them get better. At 12-month follow-up, the level of neck pain and capability to work was obtained. Whether coping preferences (baseline) were associated with outcome was investigated using multiple regression analyses. Results Persistent neck pain was most strongly associated with preferring medications (mean difference=1.24 (95% CI 0.67 to 1.82)) and sickness absence (mean difference=1.18 (95% CI 0.53 to 1.82)). Reduced work capability was most strongly associated with preferring medications (OR=3.53 (95% CI 2.13 to 5.86)), sickness absence (OR=3.05 (95% CI 1.80 to 5.17)) and being referred to a physiotherapist/chiropractor (OR=3.03 (95% CI 1.33 to 6.91)). Active coping was associated with better outcomes: Participants preferring to change their lifestyle were protected against reduced work capability (OR=0.11 (95% CI 0.01 to 0.78)). Individuals who wanted to keep living as usual only (no other preference reported) were protected against neck pain (mean difference −1.62 (95% CI −2.39 to −0.84)) and reduced work capability (OR=0.09 (95% CI 0.01 to 0.64)). Conclusions A simple nine-item measure of coping preferences is associated with the development of chronic neck pain and reduced capability to work following whiplash trauma and may be used to identify individuals at risk of poor recovery. PMID:25795697

  6. Pharmacists' interventions on clinical asthma outcomes: a systematic review.

    PubMed

    Garcia-Cardenas, Victoria; Armour, Carol; Benrimoj, Shalom I; Martinez-Martinez, Fernando; Rotta, Inajara; Fernandez-Llimos, Fernando

    2016-04-01

    The objective of this systematic review was to evaluate the impact of pharmacists' interventions on clinical asthma outcomes on adult patients and to identify the outcome indicators used.PubMed, Scopus, Web of Science and Scielo were searched. Studies addressing pharmacists' interventions on adult asthma patients reporting clinical asthma outcomes were incorporated.11 clinical outcomes were identified in 21 studies. 10 studies measured the impact of the intervention on asthma control. Randomised controlled trials (RCT) and non-RCTs found positive results in percentages of controlled patients and Asthma Control Questionnaire (ACQ) scores. Discordant results were found for Asthma Control Test results. Asthma severity was assessed in four studies. One RCT found a significant decrease in the percentage of severe patients; two non-RCTs found significant improvements in severity scores. 11 studies reported pulmonary function indicators, showing inconsistent results. Eight studies measured asthma symptoms; three RCTs and four non-RCTs showed significant improvements.RCTs and non-RCTs generated similar results for most outcomes. Based on the evidence generated by RCTs, pharmacists' have a positive impact on the percentage of controlled patients, ACQ scores, severity and symptoms. Future research should report using the core outcome set of indicators established for asthma (PROSPERO CRD42014007019). PMID:26677937

  7. 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

  8. Clinical outcomes for Conduits and Scaffolds in peripheral nerve repair

    PubMed Central

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

    2015-01-01

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

  9. Personal Health Technologies in Employee Health Promotion: Usage Activity, Usefulness, and Health-Related Outcomes in a 1-Year Randomized Controlled Trial

    PubMed Central

    Orsama, Anna-Leena; Ahtinen, Aino; Hopsu, Leila; Leino, Timo; Korhonen, Ilkka

    2013-01-01

    Background Common risk factors such as obesity, poor nutrition, physical inactivity, stress, and sleep deprivation threaten the wellness and work ability of employees. Personal health technologies may help improve engagement in health promotion programs and maintenance of their effect. Objective This study investigated personal health technologies in supporting employee health promotion targeting multiple behavioral health risks. We studied the relations of usage activity to demographic and physiological characteristics, health-related outcomes (weight, aerobic fitness, blood pressure and cholesterol), and the perceived usefulness of technologies in wellness management. Methods We conducted a subgroup analysis of the technology group (114 subjects, 33 males, average age 45 years, average BMI 27.1 kg/m2) of a 3-arm randomized controlled trial (N=352). The trial was organized to study the efficacy of a face-to-face group intervention supported by technologies, including Web services, mobile applications, and personal monitoring devices. Technology usage was investigated based on log files and questionnaires. The associations between sustained usage of Web and mobile technologies and demographic and physiological characteristics were analyzed by comparing the baseline data of sustained and non-sustained users. The associations between sustained usage and changes in health-related outcomes were studied by repeated analysis of variance, using data measured by baseline and end questionnaires, and anthropometric and laboratory measurements. The experienced usability, usefulness, motivation, and barriers to using technologies were investigated by 4 questionnaires and 2 interviews. Results 111 subjects (97.4%) used technologies at some point of the study, and 33 (29.9%) were classified as sustained users of Web or mobile technologies. Simple technologies, weight scales and pedometer, attracted the most users. The sustained users were slightly older 47 years (95% CI 44 to 49

  10. Early clinical outcomes following laparoscopic inguinal hernia repair.

    PubMed

    Tolver, Mette Astrup

    2013-07-01

    Laparoscopic inguinal hernia repair (TAPP) has gained increasing popularity because of less post-operative pain and a shorter duration of convalescence compared with open hernia repair technique (Lichtenstein). However, investigation of duration of convalescence with non-restrictive recommendations, and a procedure-specific characterization of the early clinical outcomes after TAPP was lacking. Furthermore, optimization of the post-operative period with fibrin sealant versus tacks for fixation of mesh, and the glucocorticoid dexamethasone versus placebo needed to be investigated in randomized clinical trials. The objective of this PhD thesis was to characterize the early clinical outcomes after TAPP and optimize the post-operative period. The four studies included in this thesis have investigated duration of convalescence and procedure-specific post-operative pain and other early clinical outcomes after TAPP. Furthermore, it has been shown that fibrin sealant can improve the early post-operative period compared with tacks, while dexamethasone showed no advantages apart from reduced use of antiemetics compared with placebo. Based on these findings, and the existing knowledge, 3-5 days of convalescence should be expected when 1 day of convalescence is recommended and future studies should focus on reducing intraabdominal pain after TAPP. Fibrin sealant can optimize the early clinical outcomes but the risk of hernia recurrence and chronic pain needs to be evaluated. Dexamethasone should be investigated in higher doses. PMID:23809977

  11. 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.

  12. Pulmonary Embolism in Ischemic Stroke: Clinical Presentation, Risk Factors, and Outcome

    PubMed Central

    Pongmoragot, Jitphapa; Rabinstein, Alejandro A.; Nilanont, Yongchai; Swartz, Richard H.; Zhou, Limei; Saposnik, Gustavo

    2013-01-01

    Background Limited information is available on the frequency of pulmonary embolism (PE) in patients with an acute ischemic stroke (AIS). We evaluated clinical characteristics, predisposing factors, and outcomes in AIS patients with PE. Methods and Results We included all AIS patients admitted to participating institutions in the Registry of the Canadian Stroke Network. Clinically PE was documented by a physician and confirmed by computed tomography pulmonary angiography within 30 days of the stroke case index. The primary outcome was death or disability at discharge. Secondary outcomes included disposition, length of hospital stay, mortality at 3 months and 1 year. Among 11 287 patients with AIS, PE was found in 89 (0.78%) patients. History of cancer, deep vein thrombosis (DVT)/PE, and DVT during the hospitalization were associated with PE. PE was associated with higher risk of death at 30 days (25.8% versus 13.6%; P<0.001), at 1 year (47.2% versus 24.6%; P<0.001), and disability at discharge (85.4% versus 63.6%; P<0.001). Mean length of stay was longer in stroke patients with PE (36 versus 16 days; P=0.001). After adjusting for age, sex, and stroke severity, PE remained associated with lower survival at 30 days and 1 year, and death or disability at discharge (OR 3.02; 95% CI 1.56 to 5.83). Conclusions In this large cohort study, PE occurred in nearly 1% of AIS patients. PE was more common in patients with severe stroke, history of cancer, previous DVT/PE or acute DVT and associated with lower short‐ and long‐term survival, greater disability, and longer length of stay. PMID:24275627

  13. 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

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

    PubMed

    Henggeler, Scott W; Schaeffer, Cindy M

    2016-09-01

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

  15. Outcome Markers for Clinical Trials in Cerebral Amyloid Angiopathy

    PubMed Central

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

    2014-01-01

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

  16. 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

  17. 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

  18. Surgical Predictors of Clinical Outcome following Revision ACL Reconstruction

    PubMed Central

    Wright, Rick W.

    2016-01-01

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

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

    PubMed

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

    2014-03-01

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

  20. Preoperative indicators of clinical outcome following stereotaxic pallidotomy.

    PubMed

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

    1997-10-01

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

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

    PubMed Central

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

    2016-01-01

    Objective The use of transcatheter aortic valve implantation (TAVI) is growing rapidly in countries with a predominantly elderly population, posing a huge challenge to healthcare systems worldwide. The increment of human and economic resource consumption imposes a careful monitoring of clinical outcomes and cost-benefit balance, and this article is aimed at analysing clinical outcomes related to the TAVI learning curve. Methods Outcomes of 177 consecutive transfemoral TAVI procedures performed in 5 years by a single team were analysed by the Cumulative Sum of failures method (CUSUM) according to the clinical events comprised in the Valve Academic Research Consortium (VARC-2) safety end point and the VARC-2 definition of device success. Margins for events acceptance were extrapolated from landmark trials that tested both balloon or self-expandable percutaneous valves. Results 30-day and 1-year survival rates were 97.2% and 89.9%, respectively. Achievement of the primary end point (number of cases needed to provide the acceptable margin of the composite end point of any death, stroke, myocardial infarction, life-threatening bleeding, major vascular complications, stage 2–3 acute kidney injury and valve-related dysfunction requiring a repeat procedure) required the performance of 54 cases, while the learning curve to achieve ‘device success’ identified 32 cases to reach the expected proficiency. In this experience, the baseline clinical risk as assessed by the Society of Thoracic Surgeons (STS) score determined the long-term survival rather than the adverse events related to the learning curve. Conclusions A relatively large number of cases are required to achieve clinical outcomes comparable to those reported in high-volume centres and controlled trials. According to our national workload standards, this represents more than 2 years of continuous activity. PMID:27621826

  2. 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…

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

    PubMed

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

    2016-06-01

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

  4. Scaphoid morphology and clinical outcomes in scaphoid reconstructions.

    PubMed

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

    2012-03-01

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

  5. Correlation of Reconstructed Scaphoid Morphology with Clinical Outcomes

    PubMed Central

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

    2015-01-01

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

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

    PubMed

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

    2016-07-01

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

  7. Clinical Manifestations and Outcomes of West Nile Virus Infection

    PubMed Central

    Sejvar, James J.

    2014-01-01

    Since the emergence of West Nile virus (WNV) in North America in 1999, understanding of the clinical features, spectrum of illness and eventual functional outcomes of human illness has increased tremendously. Most human infections with WNV remain clinically silent. Among those persons developing symptomatic illness, most develop a self-limited febrile illness. More severe illness with WNV (West Nile neuroinvasive disease, WNND) is manifested as meningitis, encephalitis or an acute anterior (polio) myelitis. These manifestations are generally more prevalent in older persons or those with immunosuppression. In the future, a more thorough understanding of the long-term physical, cognitive and functional outcomes of persons recovering from WNV illness will be important in understanding the overall illness burden. PMID:24509812

  8. 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

  9. Predicting outcome in clinically isolated syndrome using machine learning

    PubMed Central

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

    2014-01-01

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

  10. 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

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

    PubMed

    Castagnini, Luis A; Munoz, Flor M

    2010-03-01

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

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

    PubMed

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

    2016-06-01

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

  13. 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

  14. Rehabilitation Predictors of Clinical Outcome following Revision ACL Reconstruction

    PubMed Central

    Wright, Rick W.; Group, Mars

    2016-01-01

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

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

    PubMed

    Annapureddy, N; Devilliers, H; Jolly, M

    2016-09-01

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

  16. Clinical outcome of collateral ligament injuries of the tarsus

    PubMed Central

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

    2012-01-01

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

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

    PubMed Central

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

    2016-01-01

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

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

    PubMed

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

    2010-05-30

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

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

    PubMed Central

    Harrington, Shana; Gilchrist, Laura; Sander, Antoinette

    2014-01-01

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

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

    PubMed

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

    2016-06-01

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

  1. Clinical and esthetic outcomes of single-tooth implants in the anterior maxilla.

    PubMed

    Furze, David; Byrne, Ashley; Donos, Nikolaos; Mardas, Nikos

    2012-02-01

    The aim of this study was to evaluate the clinical and esthetic outcomes of 10 consecutive single-tooth implant restorations in the anterior maxilla. A specific treatment protocol consisting of (1) atraumatic extraction of the failing tooth, (2) placement of an SLActive bone-level implant with simultaneous guided bone regeneration at 6 to 8 weeks postextraction, (3) loading of a provisional restoration at 2 to 3 months following implant placement, (4) production of a customized impression coping, and (5) loading of the definitive all-ceramic abutment and crown 6 months after delivery of the provisional restoration was utilized in all cases. The outcomes were assessed 1 year after loading of the definitive restoration using standard clinical parameters: pink (PES) and white esthetic scores (WES). All implants were successfully integrated, accounting for a 100% survival and success rate. Besides clinical success, the application of the specific treatment protocol may be able to provide esthetically pleasing single-tooth implant restorations in the anterior maxilla, as was demonstrated by the results for PES (7.9 ± 1.7) and WES (7.0 ± 1.5). PMID:22257874

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

    PubMed Central

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

    2015-01-01

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

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

    PubMed

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

    2016-01-01

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

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

    PubMed Central

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

    2016-01-01

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

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

    PubMed

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

    2013-10-01

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

  6. Clinical characteristics and outcome of cancer diagnosed during pregnancy

    PubMed Central

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

    2016-01-01

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

  7. Clinical Outcomes Following Arthroscopic Micro Fracture of the Hip

    PubMed Central

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

    2016-01-01

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

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

    PubMed

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

    2015-09-01

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

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

    PubMed Central

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

    2016-01-01

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

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

    PubMed

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

    2016-03-01

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

  11. Clinical outcomes of endovascularly managed iatrogenic renal hemorrhages

    PubMed Central

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

    2015-01-01

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

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

    PubMed Central

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

    2009-01-01

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

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

    PubMed Central

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

    2000-01-01

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

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

    PubMed Central

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

    2016-01-01

    Objective To compare the clinical outcomes following conservative treatment and arthroscopic repair in patients with a rotator cuff tear. Methods In this retrospective study, patients aged >50 years with a symptomatic rotator cuff tear were reviewed. The rotator cuff tendons were evaluated using ultrasonography, shoulder magnetic resonance imaging or MR arthrography, and the patients with either a high-grade partial-thickness or small-to-medium-sized (≤3 cm) full-thickness tear were included in this study. The primary outcome measures were a pain assessment score and range of motion (ROM) at 1-year follow-up. The secondary outcomes were the rate of tear progression or retear along with the rate of symptom aggravation after the treatments. Results A total of 357 patients were enrolled, including 183 patients that received conservative treatment and 174 patients who received an arthroscopic repair. The pain assessment score (p<0.001) and the ROM in forward flexion (p<0.001) were significantly improved in both groups. The ROM in internal rotation did not significantly change after conservative treatment and arthroscopic repair. The pain assessment score and ROM were not significantly different between the two groups. Retear was observed in 9.6% of patients who had an arthroscopic repair and tear progression was found in 6.7% of those who underwent conservative treatment. The proportion of aggravation for pain and ROM did not significantly differ between the two groups. Conclusion The effectiveness of conservative treatment is not inferior to arthroscopic repair for patients >50 years old with a less than medium-sized rotator cuff tear in a 1-year follow-up period. Further study is warranted to find the optimal combination of conservative treatment for a symptomatic rotator cuff tear. PMID:27152275

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

    PubMed

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

    2016-01-01

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

  16. 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

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

    PubMed Central

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

    2011-01-01

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

  18. Clinical Outcomes Associated with Treatment Modalities for Gastrointestinal Bezoars

    PubMed Central

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

    2014-01-01

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

  19. Impact of body mass index on clinical outcome in patients with acute coronary syndromes treated with percutaneous coronary intervention.

    PubMed

    Ndrepepa, Gjin; Keta, Dritan; Byrne, Robert A; Schulz, Stefanie; Mehilli, Julinda; Seyfarth, Melchior; Schömig, Albert; Kastrati, Adnan

    2010-01-01

    Studies that have tested the relationship between body weight as assessed by body mass index (BMI) and clinical outcome after percutaneous coronary intervention (PCI) have given contradictory results. The aim of the study was to investigate the impact of BMI on clinical outcome and assess the impact of adjustment for other cardiovascular risk factors on the relationship between obesity and clinical outcome in patients with acute coronary syndromes (ACS) following PCI. This study included 9146 patients with ACS who underwent coronary angiography and PCI: 2610 patients with ST-segment elevation acute myocardial infarction, 2792 patients with non-ST-segment elevation acute myocardial infarction, and 3744 patients with unstable angina. The primary outcome of this analysis was 1-year mortality. Quartiles of BMI were: 12.8 to <24.3 (1st quartile), 24.3 to <26.4 (2nd quartile), 26.4 to <29.1 (3rd quartile), and >29.1 to 50.7 (4th quartile). Within the first year following PCI, there were 756 deaths: 228 deaths in the 1st BMI quartile, 209 deaths in the 2nd BMI quartile, 161 deaths in the 3rd BMI quartile and 158 deaths in the 4th BMI quartile (Kaplan-Meier estimates of mortality 10.3%, 9.1%, 7.2%, and 7.0%, respectively; odds ratio [OR] = 1.51, 95% confidence interval [CI] 1.22-1.86, P < 0.001 for 1st vs 4th BMI quartile). After adjustment in the Cox proportional hazards model, the association between BMI and 1-year mortality was attenuated to the level of statistical insignificance (hazards ratio [HR] = 1.25, 95% CI 0.94-1.64; P = 0.127 for 1st vs 4th BMI quartile). In conclusion, in patients with ACS undergoing PCI, obesity as assessed with BMI was not an independent correlate of 1-year mortality. PMID:20091395

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

    PubMed

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

    2012-01-01

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

  1. Clinical Outcomes following median to radial nerve transfers

    PubMed Central

    Ray, Wilson Z.; Mackinnon, Susan E.

    2010-01-01

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

  2. Prospective assessment of patterns, severity and clinical outcome of Indian poisoning incidents.

    PubMed

    Churi, Shobha; Ramesh, Madhan; Bhakta, Krunal; Chris, Jacob

    2012-01-01

    The objective of this study was to assess the patterns, severity and clinical outcome of poisoning incidents. A prospective assessment was conducted over a period of 1 year in tertiary-care teaching hospitals. Glasgow coma scale (GCS), poisoning severity score (PSS), and snake bite severity score (SSS) were used to predict the severity of poisoning, and then compared to the clinical outcome. The study involved 212 patients with a mean age of 26.7±12.7 years. Pesticides were found to be the most common poisoning agents. The incidents of intentional poisoning (n=178) were higher than accidental (n=34) poisoning. Poisoning incidents were higher in male population (n=132) compared to female population (n=80). The poisoning incidents were predominantly higher among literates (n=155). The poisoning incidents were higher in rural areas (n=129), followed by urban (n=53) and semi-urban (n=30) areas. The poisoning incidents were highest in the middle class population (n=108), followed by poor class (n=101) and rich class (n=3) population. A majority of patients whose severity of illness was predicted to be mild to moderate recovered from the poisoning. In contrast, patients whose illness was predicted to be severe were either discharged with severe morbidity or deceased. There was a moderate correlation between GCS and PSS scoring systems (r=0.51, p<0.001). PMID:22790818

  3. 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

  4. Tocilizumab in systemic juvenile idiopathic arthritis in a real-world clinical setting: results from 1 year of postmarketing surveillance follow-up of 417 patients in Japan

    PubMed Central

    Yokota, Shumpei; Itoh, Yasuhiko; Morio, Tomohiro; Origasa, Hideki; Sumitomo, Naokata; Tomobe, Minako; Tanaka, Kunihiko; Minota, Seiji

    2016-01-01

    Objectives To evaluate the safety and effectiveness of tocilizumab (TCZ) in patients with systemic juvenile idiopathic arthritis (sJIA) in real-world clinical settings in Japan. Methods Paediatric patients with sJIA initiating TCZ between April 2008 and February 2012 and those previously enrolled in clinical trials who initiated TCZ before April 2008 were enrolled in a Japanese registry surveillance programme. Safety and effectiveness parameters were collected for 52 weeks. Results Of 417 patients enrolled, mean age was 11.2 years and 48.0% were female. TCZ exposure was 407.0 patient-years (PYs). Baseline corticosteroid use was higher than in clinical trials. Rates of total adverse events (AEs) and serious AEs (SAEs) were 224.3/100 PYs and 54.5/100 PYs, respectively, with SAEs higher than previously reported. The most frequent AEs and SAEs were infections and infestations (69.8/100 PYs and 18.2/100 PYs, respectively). 74 serious infections occurred in 55 patients (18.2/100 PYs); higher than previously reported. 26 macrophage activation syndrome events were reported in 24 patients (6.4/100 PYs). Fever and rash symptoms improved from baseline to week 52 (54.6% to 5.6% and 43.0% to 5.6%, respectively). At 4 weeks, 8 weeks and 52 weeks, 90.5%, 96.2% and 99.0% of patients achieved normal C reactive protein levels (<0.3 mg/dL), respectively. Conclusions These first real-world data demonstrated that TCZ was well tolerated, with acceptable safety and effectiveness in patients with sJIA. Higher incidences of SAEs and serious infections may be due to differences, such as corticosteroid use and concomitant diseases, between patient populations enrolled in previously reported clinical trials and this study. PMID:26644233

  5. Clinical elements that predict outcome after traumatic brain injury: a prospective multicenter recursive partitioning (decision-tree) analysis.

    PubMed

    Brown, Allen W; Malec, James F; McClelland, Robyn L; Diehl, Nancy N; Englander, Jeffrey; Cifu, David X

    2005-10-01

    Traumatic brain injury (TBI) often presents clinicians with a complex combination of clinical elements that can confound treatment and make outcome prediction challenging. Predictive models have commonly used acute physiological variables and gross clinical measures to predict mortality and basic outcome endpoints. The primary goal of this study was to consider all clinical elements available concerning a survivor of TBI admitted for inpatient rehabilitation, and identify those factors that predict disability, need for supervision, and productive activity one year after injury. The Traumatic Brain Injury Model Systems (TBIMS) database was used for decision tree analysis using recursive partitioning (n = 3463). Outcome measures included the Functional Independence Measure(), the Disability Rating Scale, the Supervision Rating Scale, and a measure of productive activity. Predictor variables included all physical examination elements, measures of injury severity (initial Glasgow Coma Scale score, duration of post-traumatic amnesia [PTA], length of coma, CT scan pathology), gender, age, and years of education. The duration of PTA, age, and most elements of the physical examination were predictive of early disability. The duration of PTA alone was selected to predict late disability and independent living. The duration of PTA, age, sitting balance, and limb strength were selected to predict productive activity at 1 year. The duration of PTA was the best predictor of outcome selected in this model for all endpoints and elements of the physical examination provided additional predictive value. Valid and reliable measures of PTA and physical impairment after TBI are important for accurate outcome prediction. PMID:16238482

  6. Outcome Measures for Clinical Trials in Interstitial Lung Diseases

    PubMed Central

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

    2015-01-01

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

  7. Stability and Clinical Outcome after Reconstruction of Complete Triangular Fibrocartilage Disruption.

    PubMed

    Hess, Florian; Sutter, Reto; Nagy, Ladislav; Schweizer, Andreas

    2016-05-01

    Purpose Patients with symptomatic instability of the distal radioulnar joint (DRUJ) after traumatic complete disruption of the triangular fibrocartilage complex (TFC) are best treated by anatomic reconstruction of the TFC. Postoperative clinical results from the literature are known but the improvement of DRUJ instability remains still challenging to quantify. We recently published a reliable and validated method to measure the instability of the DRUJ. This sonographic method was used to quantify the pre- and postoperative instability in correlation with clinical outcome in patients with complete TFC disruption. Methods 11 patients with complete disruption of the TFC resulting in symptomatic instability of the DRUJ underwent open reconstruction of the TFC. The instability was measured with sonography preoperatively and one year postoperatively including the Patient-Rated Wrist Evaluation score (PRWE Score). Results By subjective measurement, 9 patients showed comparable stability to the contralateral side. By objective measurements, DRUJ stability was completely restored in 6 patients. Seven patients had a very good and good clinical outcome. The dorsovolar shift (preoperative mean 5.2mm, min 2.4, max 7.1; postoperative 3.6mm, min 1.2, max 6.2) was significantly decreased (p < 0.05) and was postoperatively not different to the contralateral healthy side (p > 0.1). PRWE score in the 1 year follow up was 13.8. Three patients remained with significant pain, sonographically two of them were still more lax and one tighter compared to the contralateral side. Conclusions The sonographic measurement technique allows evaluation of the stability pre- and postoperatively and does not always correlate with the qualitative clinical assessment. The described operation technique is effective for treatment of irreplaceable TFC ruptures and significantly improves the DRUJ stability and wrist function one year after surgery, which could be quantified objectively by

  8. 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. PMID:26755564

  9. 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

  10. Aberrant Hedgehog Signaling and Clinical Outcome in Osteosarcoma

    PubMed Central

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

    2014-01-01

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

  11. Clinical outcomes of enjoying sexualization among lesbian women.

    PubMed

    Erchull, Mindy J; Liss, Miriam

    2015-01-01

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

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

    PubMed

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

    2010-09-01

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

  13. 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

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

    PubMed

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

    2003-12-01

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

  15. Clinical Outcome after Colonic Resection in Women with Endometriosis

    PubMed Central

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

    2015-01-01

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

  16. 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

  17. 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

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

    PubMed Central

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

    2015-01-01

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

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

    PubMed Central

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

    2015-01-01

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

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

    PubMed Central

    Benedetti, Fabrizio; Dogue, Sara

    2015-01-01

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

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

    PubMed

    Koda, Yutaka

    2011-01-01

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

  2. Imatinib mesylate (Gleevec) in the treatment of diffuse cutaneous systemic sclerosis: results of a 1-year, phase IIa, single-arm, open-label clinical trial

    PubMed Central

    Spiera, Robert F; Gordon, Jessica K; Mersten, Jamie N; Magro, Cynthia M; Mehta, Mansi; Wildman, Horatio F; Kloiber, Stacey; Kirou, Kyriakos A; Lyman, Stephen; Crow, Mary K

    2011-01-01

    Objective To assess the safety and effectiveness of imatinib mesylate in the treatment of diffuse cutaneous systemic sclerosis (dcSSc). Methods In this phase IIa, open-label, single-arm clinical trial, 30 patients with dcSSc were treated with imatinib 400 mg daily. Patients were monitored monthly for safety assessments. Modified Rodnan skin scores (MRSS) were assessed every 3 months. Pulmonary function testing, chest radiography, echocardiography and skin biopsies were performed at baseline and after 12 months of treatment. Results Twenty-four patients completed 12 months of therapy. 171 adverse events (AE) with possible relation to imatinib were identified; 97.6% were grade 1 or 2. Twenty-four serious AE were identified, two of which were attributed to study medication. MRSS decreased by 6.6 points or 22.4% at 12 months (p=0.001). This change was evident starting at the 6-month time point (Δ=−4.5; p<0.001) and was seen in patients with both early and late-stage disease. Forced vital capacity (FVC) improved by 6.4% predicted (p=0.008), and the diffusion capacity remained stable. The improvement in FVC was significantly greater in patients without interstitial lung disease. Health-related quality of life measures improved or remained stable. Blinded dermatopathological analysis confirmed a significant decrease in skin thickness and improvement in skin morphology. Conclusions Treatment with imatinib was tolerated by most patients in this cohort. Although AE were common, most were mild to moderate. In this open-label experience, improvements in skin thickening and FVC were observed. Further investigation of tyrosine kinase inhibition for dcSSc in a double-blind randomised placebo controlled trial is warranted. ClinicalTrials.gov, NCT00555581 PMID:21398330

  3. 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

  4. Prefrontal Function at Presentation Directly Related to Clinical Outcome in People at Ultrahigh Risk of Psychosis

    PubMed Central

    Fusar-Poli, P.; Broome, M.R.; Matthiasson, P.; Woolley, J.B.; Mechelli, A.; Johns, L.C.; Tabraham, P.; Bramon, E.; Valmaggia, L.; Williams, S.C.; McGuire, P.

    2011-01-01

    Background: The prodromal phase of psychosis is characterized by impaired executive function and altered prefrontal activation. The extent to which the severity of these deficits at presentation predicts subsequent clinical outcomes is unclear. Methods: We employed functional magnetic resonance imaging in a cohort of subjects at clinical risk for psychosis and in healthy controls. Images were acquired at clinical presentation and again after 1 year, using a 1.5-T Signa MRI scanner while subjects were performing a verbal fluency task. SPM5 was used for the analysis of imaging data. Psychopathological assessment of the “at-risk” symptoms was performed by using the Comprehensive Assessment for the At-Risk Mental State (CAARMS) and the Positive and Negative Symptom Scale (PANSS). Results: In the at-risk mental state (ARMS) group, between presentation and follow-up, the CAARMS (perceptual disorder and thought disorder subscales) and the PANSS general scores decreased, while the Global Assessment of Functioning (GAF) score increased. Both the ARMS and control groups performed the verbal fluency task with a high degree of accuracy. The ARMS group showed greater activation in the left inferior frontal gyrus but less activation in the anterior cingulate gyrus than controls. Within the ARMS group, the longitudinal normalization of neurofunctional response in the left inferior frontal gyrus was positively correlated with the improvement in severity of hallucination-like experiences. Conclusions: The normalization of the abnormal prefrontal response during executive functioning is associated with 12-month psychopathological improvement of prodromal symptoms. PMID:19666832

  5. Clinical characteristics and long-term outcomes of moyamoya syndrome associated with neurofibromatosis type 1.

    PubMed

    Han, Cong; Yang, Wei-Zhong; Zhang, Hong-Tao; Ye, Ting; Duan, Lian

    2015-02-01

    Moyamoya syndrome (MMS) associated with neurofibromatosis type 1 (NF1) has rarely been reported anywhere in the world, particularly in Asia. Because of the rarity of this disorder, its natural history, clinical symptoms, management, and follow-up findings remain unclear. The objective of this study was to evaluate the clinical presentation, neurological imaging, and long-term outcomes of patients with this disease by reviewing Chinese patients with MMS associated with NF1. A retrospective review was conducted from the moyamoya disease (MMD) and MMS patient database of our hospital. Six patients who were diagnosed with MMS associated with NF1 between January 2003 and October 2013 were identified. The clinical symptoms were transient ischemic attack (TIA, three patients), headache (one patient), intracerebral hemorrhage (one patient), and cerebral infarction (one patient). The mean age of diagnosis for NF1 and MMS was 2.7 ± 2.1 years (range, 1-6 years) and 11.4 ± 8.3 years (range, 3.5-23 years), respectively. Five of six patients (nine hemispheres) underwent revascularization surgery, and their clinical symptoms were stable during a 46.3 ± 36.1 month (range, 18-108 month) follow-up. One non-surgical patient had a new infarct that resulted in visual field deficits during follow-up. Three patients had radiographic follow-up, and the postoperative angiograms showed successful revascularizations in the operated hemispheres. To conclude, the clinical and radiographic features for MMS-NF1 are similar to those of typical MMD. Routine vascular screening for NF1 patients is necessary for the early identification of MMS and other cerebral arteriopathies. Revascularization surgery may prevent the progression of clinical symptoms and reduce the risk of subsequent strokes. PMID:25443089

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

    PubMed Central

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

    2014-01-01

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

  7. 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. PMID:23608306

  8. 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

  9. 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

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

    PubMed Central

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

    2013-01-01

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

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

    PubMed

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

    2015-06-01

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

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

    PubMed Central

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

    2015-01-01

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

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

    PubMed Central

    2011-01-01

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

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

    PubMed Central

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

    2011-01-01

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

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

    PubMed

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

    2013-04-01

    The standard surgical management of hip fractures is associated with tissue trauma and bleeding which are added to the fracture injury. The percutaneous compression plate (PCCP) is a minimally invasive device that has been demonstrated in previous studies to reduce postoperative complications and blood loss. This prospective, multi-center, observational study assessed clinical and functional outcomes with PCCP as treatment for trochanteric fractures. Patients with a stable or unstable proximal femoral fracture of type AO 31.A1 or 31.A2 were enrolled in eight hospitals in Italy. The primary outcome of interest was the recovery of the pre-fracture functional status at 1-year follow-up; secondary outcomes of interest included blood transfusions, surgical time, complications, and mortality. A total of 273 patients were enrolled. The ASA score was 3 or 4 in 72.5 % of patients. The mean surgical time was 44.1 min; the mean post-surgery blood transfusions was 0.9 units. At 1 year, 48 patients (17.6 %) died, 28 (10.2 %) were lost to follow-up, 4 patients (1.5 %) were excluded, hence 193 patients (70.3 %) were available for final evaluation. At the 1-year follow-up visit, 51.9 % of patients recovered or improved their pre-fracture modified Harris Hip Score, 49.1 % of patients improved or maintained their walking abilities, and 66.6 % of patients residing at home pre-surgery maintained their domicile. The overall mortality rate was 17.6 %. Major complications included two fracture collapses, one excessive sliding of the cephalic screw leading to a partial fracture collapse and one back-out of the diaphyseal screw. This study demonstrates that treatment of trochanteric fractures with PCCP gives good outcomes and significant advantages such as low blood loss, short surgical time, low risk of complications, and good functional recovery in the majority of the patients. PMID:23543403

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

    PubMed Central

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

    2012-01-01

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

  17. 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

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

    PubMed

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

    2016-03-01

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

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

    PubMed Central

    Kim, Youngmee; Evangelista, Lorraine S.

    2011-01-01

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

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

    PubMed

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

    2015-09-01

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

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

    PubMed

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

    2016-07-01

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

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

    PubMed Central

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

    2015-01-01

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

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

    PubMed Central

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

    2014-01-01

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

  4. Clinical attributes and surgical outcomes of angiocentric gliomas.

    PubMed

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

    2016-06-01

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

  5. 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

  6. 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. PMID:27239021

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

    PubMed Central

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

    2016-01-01

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

  8. 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

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

    PubMed

    Khoshkhounejad, Mehrfam; Shokouhinejad, Noushin; Pirmoazen, Salma

    2015-06-01

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

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

    PubMed Central

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

    2016-01-01

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

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

    PubMed Central

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

    2012-01-01

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

  12. 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

  13. Systematic review of clinical outcomes after prophylactic surgery.

    PubMed

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

    2016-07-01

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

  14. Reversed portal flow: Clinical influence on the long-term outcomes in cirrhosis

    PubMed Central

    Kondo, Takayuki; Maruyama, Hitoshi; Sekimoto, Tadashi; Shimada, Taro; Takahashi, Masanori; Yokosuka, Osamu

    2015-01-01

    AIM: To elucidate the natural history and the longitudinal outcomes in cirrhotic patients with non-forward portal flow (NFPF). METHODS: The present retrospective study consisted of 222 cirrhotic patients (120 males and 102 females; age, 61.7 ± 11.1 years). The portal hemodynamics were evaluated at baseline and during the observation period using both pulsed and color Doppler ultrasonography. The diameter (mm), flow direction, mean flow velocity (cm/s), and mean flow volume (mL/min) were assessed at the portal trunk, the splenic vein, the superior mesenteric vein, and the collateral vessels. The average values from 2 to 4 measurements were used for the data analysis. The portal flow direction was defined as follows: forward portal flow (FPF) for continuous hepatopetal flow; bidirectional flow for to-and-fro flow; and reversed flow for continuous hepatofugal flow. The bidirectional flow and the reversed flow were classified as NFPF in this study. The clinical findings and prognosis were compared between the patients with FPF and those with NFPF. The median follow-up period was 40.9 mo (range, 0.3-156.5 mo). RESULTS: Twenty-four patients (10.8%) demonstrated NFPF, accompanied by lower albumin level, worse Child-Pugh scores, and model for end-stage liver disease scores. The portal hemodynamic features in the patients with NFPF were smaller diameter of the portal trunk; presence of short gastric vein, splenorenal shunt, or inferior mesenteric vein; and advanced collateral vessels (diameter > 8.7 mm, flow velocity > 10.2 cm/s, and flow volume > 310 mL/min). The cumulative incidence rates of NFPF were 6.5% at 1 year, 14.5% at 3 years, and 23.1% at 5 years. The collateral vessels characterized by flow velocity > 9.5 cm/s and those located at the splenic hilum were significant predictive factors for developing NFPF. The cumulative survival rate was significantly lower in the patients with NFPF (72.2% at 1 year, 38.5% at 3 years, 38.5% at 5 years) than in those with forward

  15. 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.

  16. Clinical outcomes and mortality in elderly peritoneal dialysis patients

    PubMed Central

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

    2015-01-01

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

  17. 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.

  18. 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

  19. Clinical Outcomes after Parathyroidectomy in a Nationwide Cohort of Patients on Hemodialysis

    PubMed Central

    Liu, Jiannong; Wetmore, James B.; Lowe, Kimberly A.; Do, Thy; Bradbury, Brian D.; Block, Geoffrey A.; Collins, Allan J.

    2015-01-01

    Background and objectives Patients receiving dialysis undergo parathyroidectomy to improve laboratory parameters in resistant hyperparathyroidism with the assumption that clinical outcomes will also improve. However, no randomized clinical trial data demonstrate the benefits of parathyroidectomy. This study aimed to evaluate clinical outcomes up to 1 year after parathyroidectomy in a nationwide sample of patients receiving hemodialysis. Design, setting, participants, & measurements Using data from the US Renal Data System, this study identified prevalent hemodialysis patients aged ≥18 years with Medicare as primary payers who underwent parathyroidectomy from 2007 to 2009. Baseline characteristics and comorbid conditions were assessed in the year preceding parathyroidectomy; clinical events were identified in the year preceding and the year after parathyroidectomy. After parathyroidectomy, patients were censored at death, loss of Medicare coverage, kidney transplant, change in dialysis modality, or 365 days. This study estimated cause-specific event rates for both periods and rate ratios comparing event rates in the postparathyroidectomy versus preparathyroidectomy periods. Results Of 4435 patients who underwent parathyroidectomy, 2.0% died during the parathyroidectomy hospitalization and the 30 days after discharge. During the 30 days after discharge, 23.8% of patients were rehospitalized; 29.3% of these patients required intensive care. In the year after parathyroidectomy, hospitalizations were higher by 39%, hospital days by 58%, intensive care unit admissions by 69%, and emergency room/observation visits requiring hypocalcemia treatment by 20-fold compared with the preceding year. Cause-specific hospitalizations were higher for acute myocardial infarction (rate ratio, 1.98; 95% confidence interval, 1.60 to 2.46) and dysrhythmia (rate ratio 1.4; 95% confidence interval1.16 to 1.78); fracture rates did not differ (rate ratio 0.82; 95% confidence interval 0.6 to

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

    PubMed Central

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

    2009-01-01

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

  1. Intracranial idiopathic hypertension: 1-year follow-up study.

    PubMed

    D'Amico, D; Curone, M; Erbetta, A; Farago', G; Bianchi-Marzoli, S; Ciasca, P; Bussone, G; Chiapparini, L

    2014-05-01

    Standard guidelines for ongoing management, as well as definitive data about the long-term course of idiopathic intracranial hypertension (IIH) are not available. The aim of this study was to compare several clinical and instrumental variables as assessed at the time of diagnosis and then after 1 year in a sample of IIH patients. A total of 21 patients were studied. Our results confirmed that headache and TVO are the most frequent symptoms in IIH patients, and that overweight is a very common feature. A trend towards a favorable outcome in patients followed for 1 year and treated by usual medical therapy was found: intracranial pressure was lower at follow-up; improvement of headache and transient visual obscurations, as well as of papilledema, was reported in most patients. On the other hand, neuroradiological findings (such as empty sella, perioptic subarachnoid space distension, narrowing of the transverse sinuses) were substantially stable at follow. These findings may be relevant for future research as far as understanding the role of different clinical and instrumental findings as diagnostic items as well as predictors of outcome in IIH. PMID:24867861

  2. 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

  3. 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

  4. Clinical outcome of small hepatocellular carcinoma after different treatments: A meta-analysis

    PubMed Central

    Dong, Wei; Zhang, Ting; Wang, Zhen-Guang; Liu, Hui

    2014-01-01

    AIM: To compare clinical outcomes between surgical resection (RES) and nonsurgical-RES (nRES) ablation therapies for small hepatocellular carcinoma (HCC). METHODS: MEDLINE, Embase and Cochrane Library databases were systematically searched for studies of RES and nRES treatments for small HCC between January 2003 and October 2013. The clinical outcome measures evaluated included overall survival rate, disease-free survival rate, adverse events, and local recurrence rate. Odds ratios (ORs) with 95%CIs were calculated using either the fixed effects model or random effects model. The χ2 and I2 tests were calculated to assess the heterogeneity of the data. Funnel plots were used to assess the risk of publication bias. RESULTS: Our analysis included 12 studies that consisted of a total of 1952 patients (RES vs nRES), five studies that consisted of 701 patients [radiofrequency ablation (RFA) vs percutaneous ethanol injection (PEI)], and five additional studies [RFA vs RFA + transcatheter arterial chemoembolization (TACE)] that all addressed the treatment of small HCC. For cases of RES vs nRES, there was no significant difference in the 1-year (OR = 0.99, 95%CI: 0.87-1.12, P = 0.85) or 3-year (OR = 0.97, 95%CI: 0.84-1.11, P = 0.98) overall survival rate; however, there was a significant increase in the RES group in the 5-year overall survival rate (OR = 0.81, 95%CI: 0.68-0.95, P = 0.01). The 1-year (OR = 0.94, 95%CI: 0.82-1.08, P = 0.37) and 5-year (OR = 0.99, 95%CI: 0.85-1.14, P = 0.85) disease-free survival rates showed no significant differences between the two groups. The 3-year disease-free survival rate (OR = 0.81, 95%CI: 0.69-0.96; P = 0.02) was higher in the RES group. For cases of RFA vs PEI, our data analysis indicated that RFA treatment was associated with significantly higher 2-year (OR = 0.76, 95%CI: 0.58-0.99, P = 0.043) and 3-year (OR = 0.73, 95%CI: 0.54-0.98, P = 0.039) overall survival rates; however, there were no significant differences in the 1-year

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

    PubMed

    Kvist, T

    2001-01-01

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

  6. Clinical Outcomes of Medial Meniscus Posterior Root Tears

    PubMed Central

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

    2016-01-01

    diagnosis. After initial diagnosis, 59 (58%) underwent subsequent surgical treatment. This included 52 (51%) patients undergoing arthroscopic partial meniscectomy, and 29 (28%) patients undergoing total knee arthroplasty at a mean 38±32 (range 3-107) months after MRI. Kellgren-Lawrence grades worsened from 1.3±0.7 before diagnosis to 2.2±1.0 after (p<0.001), with a mean 44±32 months between radiographs. There was a higher rate of radiographic arthritis (K-L grade 2+) after diagnosis (73%) than before diagnosis (36%) (p<0.001). The presence of meniscal extrusion on MRI was associated with the presence of arthritis on post-diagnosis radiographs (p=0.03). Meniscal extrusion, subchondral edema, and insufficiency fractures were not associated with increased rates of surgical treatment, or time to arthroplasty. Conclusion: Little information is available to guide patients and physicians on the clinical outcomes for MMPRTs. These injuries are associated with a relatively high rate of arthroplasty and worsening arthritis, especially with concomitant meniscal extrusion. More information is needed to determine the efficacy of meniscal root repair in preventing these unfavorable outcomes.

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

    PubMed

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

    2016-04-01

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

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

    PubMed Central

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

    2014-01-01

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

  9. 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

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

    PubMed Central

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

    2014-01-01

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

  11. 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.

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

    PubMed Central

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

    2014-01-01

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

  13. Baseline Serum Osteopontin Levels Predict the Clinical Effectiveness of Tocilizumab but Not Infliximab in Biologic-Naïve Patients with Rheumatoid Arthritis: A Single-Center Prospective Study at 1 Year (the Keio First-Bio Cohort Study)

    PubMed Central

    Izumi, Keisuke; Kaneko, Yuko; Hashizume, Misato; Yoshimoto, Keiko; Takeuchi, Tsutomu

    2015-01-01

    Objective To explore the baseline predictors of clinical effectiveness after tocilizumab or infliximab treatment in biologic-naïve rheumatoid arthritis patients. Methods Consecutive biologic-naïve patients with rheumatoid arthritis initiating infliximab (n = 57) or tocilizumab (n = 70) treatment were included in our prospective cohort study. Our cohort started in February 2010, and the patients observed for at least 1 year as of April 2013 were analysed. We assessed baseline variables including patients' characteristics (age, sex, disease duration, prednisolone dose, methotrexate dose, other disease-modifying antirheumatic drug use, Clinical Disease Activity Index [CDAI]) and serum biomarker levels (C-reactive protein, immunoglobulin M-rheumatoid factor, anti-cyclic citrullinated protein/peptide antibodies, interferon-γ, interleukin (IL)-1β, IL-2, IL-6, IL-8, IL-10, IL-17, tumor necrosis factor-α, soluble intercellular adhesion molecule-1, bone alkaline phosphatase, osteonectin, osteopontin) to extract factors associated with clinical remission (CDAI≤2.8) at 1 year using univariate analyses, and the extracted factors were entered into a multivariate logistic regression model. Similar analyses were also performed for Simplified Disease Activity Index (SDAI) remission (≤3.3) and Disease Activity Score with 28 joint counts, erythrocyte sedimentation rate (DAS28-ESR) remission (<2.6). Results There were no significant differences in the baseline characteristics except for methotrexate use between the groups. In the multivariate analyses, the low baseline osteopontin levels (OR 0.9145, 95% CI 0.8399–0.9857) were identified as predictors of CDAI remission in the tocilizumab group, whereas no predictors of CDAI remission were found in the infliximab group. Similar results were obtained when using SDAI and DAS28-ESR remission criteria. Conclusion Baseline low serum osteopontin levels predict clinical remission 1 year after tocilizumab treatment and not

  14. 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...

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

    ERIC Educational Resources Information Center

    Doss, Amanda Jensen; Weisz, John R.

    2006-01-01

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

  16. Emotional Development: 1 Year Olds

    MedlinePlus

    ... Español Text Size Email Print Share Emotional Development: 1 Year Olds Page Content Article Body Throughout her ... for shelter. She may seem to change from one moment to the next, or she may seem ...

  17. Social Development: 1 Year Olds

    MedlinePlus

    ... Stages Prenatal Baby Toddler Fitness Nutrition Toilet Training Preschool Gradeschool Teen Young Adult Healthy Children > Ages & Stages > Toddler > Social Development: 1 Year Olds Ages & Stages Listen Español ...

  18. 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.

  19. 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. PMID:26120765

  20. 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

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

    PubMed

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

    2016-04-01

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

  2. Esthetic Outcomes of Single-Tooth Implant-Supported Restorations Using Metal-Ceramic Restorations with Zirconia or Titanium Abutments: A Randomized Controlled Clinical Study.

    PubMed

    Baldini, Nicola; D'Elia, Chiara; Clementini, Marco; Carrillo de Albornoz, Ana; Sanz, Mariano; De Sanctis, Massimo

    2016-01-01

    The aim of this study was to test whether zirconia abutments exhibit the same clinical and esthetic outcomes as titanium abutments in single-tooth implant restorations in the esthetic area. The 24 treated patients were randomly assigned to a test (zirconia abutment) or control (titanium abutment) group. Objective evaluations were carried out using the Implant Crown Aesthetic Index (ICAI) and the Papilla Index (PI) at the 1-month and 12-month follow-up examinations after crown cementation. No significant differences, either in ICAI or in other periodontal or radiographic measurements, were observed. At 1 year, zirconia and titanium abutments exhibited the same esthetic outcomes. PMID:27333019

  3. Clinical outcomes and ergonomics analysis of three laparoscopic techniques for Hirschsprung's disease

    PubMed Central

    Aubdoollah, Tajammool Hussein; Li, Kang; Zhang, Xi; Li, Shuai; Yang, Li; Lei, Hai-Yan; Dolo, Ponnie Robertlee; Xiang, Xian-Cai; Cao, Guo-Qing; Wang, Guo-Bin; Tang, Shao-Tao

    2015-01-01

    AIM: To report the clinical outcomes and ergonomics analysis of three laparoscopic approaches in the management of Hirschsprung’s disease (HD). METHODS: There were 90 pediatric patients (63 boys, 27 girls; mean age: 3.6 ± 2.7 mo; range: 1.0-90.2 mo) who underwent laparoscopic endorectal pull-through Soave procedures for short- and long-segment HD in our hospital. Three laparoscopic approaches were used: conventional laparoscopic pull-through (CLP) in 30 patients between 2009 and 2013, single-incision laparoscopic pull-through (SILP) in 28 patients between 2010 and 2013, and hybrid single-incision laparoscopic pull-through (H-SILP) in 32 patients between 2011 and 2013. We applied the hybrid version of the single-incision approach in 2011 to preserve the cosmetic advantage of SILP and the ergonomic advantage of CLP. We retrospectively analyzed the clinical data, cosmetic results, and ergonomics of these three approaches to have a better understanding of the selection of one approach over another. RESULTS: The CLP, SILP, and H-SILP groups were similar in regard to age, sex, transition zone, blood loss, hospital stay, and intraoperative complications. Early and late postoperative results were not different, with equal daily defecation frequency and postoperative complications. No conversion to open technique was needed and none of the patients had recurrent constipation. With proper training, the ergonomics challenges were overcome and similar operative times were registered for the general operative time in the patients < 1 year of age and the short-segment HD patients. However, significantly shorter operative times were registered compared to SILP for patients > 1 year of age (CLP and H-SILP: 120 ± 15 min and 119 ± 12 min, respectively, vs 140 ± 7 min; P < 0.05) and for long-segment HD patients (152 ± 3.5 min and 154 ± 3.6 min, respectively, vs 176 ± 2.3 min; P < 0.05). The best cosmetic result was registered with the SILP (scarless), followed by the H

  4. 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

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

    PubMed

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

    2016-04-01

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

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

    ERIC Educational Resources Information Center

    Kelly, Peter James

    2010-01-01

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

  7. Factors associated with adverse clinical outcomes among obstetric trainees

    PubMed Central

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

    2016-01-01

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

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

    PubMed Central

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

    2015-01-01

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

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

    PubMed

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

    2008-06-01

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

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

    PubMed Central

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

    2015-01-01

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

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

    PubMed Central

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

    2016-01-01

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

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

    PubMed

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

    2013-12-01

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

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

    PubMed Central

    Terry, Mark A.

    2007-01-01

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

  14. 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

  15. Clinical Aggressiveness and Long-Term Outcome in Patients with Papillary Thyroid Cancer and Circulating Anti-Thyroglobulin Autoantibodies

    PubMed Central

    Durante, Cosimo; Tognini, Sara; Montesano, Teresa; Orlandi, Fabio; Torlontano, Massimo; Puxeddu, Efisio; Attard, Marco; Costante, Giuseppe; Tumino, Salvatore; Meringolo, Domenico; Bruno, Rocco; Trulli, Fabiana; Toteda, Maria; Redler, Adriano; Ronga, Giuseppe; Monzani, Fabio

    2014-01-01

    Objective: The association between papillary thyroid cancer (PTC) and Hashimoto's thyroiditis is widely recognized, but less is known about the possible link between circulating anti-thyroglobulin antibody (TgAb) titers and PTC aggressiveness. To shed light on this issue, we retrospectively examined a large series of PTC patients with and without positive TgAb. Methods: Data on 220 TgAb-positive PTC patients (study cohort) were retrospectively collected in 10 hospital-based referral centers. All the patients had undergone near-total thyroidectomy with or without radioiodine remnant ablation. Tumor characteristics and long-term outcomes (follow-up range: 2.5–24.8 years) were compared with those recently reported in 1020 TgAb-negative PTC patients with similar demographic characteristics. We also assessed the impact on clinical outcome of early titer disappearance in the TgAb-positive group. Results: At baseline, the study cohort (mean age 45.9 years, range 12.5–84.1 years; 85% female) had a significantly higher prevalence of high-risk patients (6.9% vs. 3.2%, p<0.05) and extrathyroidal tumor extension (28.2% vs. 24%; p<0.0001) than TgAb-negative controls. Study cohort patients were also more likely than controls to have persistent disease at the 1-year visit (13.6% vs. 7.0%, p=0.001) or recurrence during subsequent follow-up (5.8% vs. 1.4%, p=0.0001). At the final follow-up visit, the percentage of patients with either persistent or recurrent disease in the two cohorts was significantly different (6.4% of TgAb-positive patients vs. 1.7% in the TgAb-negative group, p<0.0001). At the 1-year visit, titer normalization was observed in 85 of the 220 TgAb-positive individuals. These patients had a significantly lower rate of persistent disease than those who were still TgAb positive (8.2% vs. 17.3%. p=0.05), and no relapses were observed among patients with no evidence of disease during subsequent follow-up. Conclusions: PTC patients with positive serum TgAb titer

  16. 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. PMID:26933611

  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 Central

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

    2015-01-01

    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/m2, 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. PMID:26933611

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

    PubMed Central

    Narang, Priya; Agarwal, Amar

    2015-01-01

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

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

    PubMed

    Dennison, J B; Sarrett, D C

    2012-04-01

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

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

    PubMed Central

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

    2015-01-01

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

  1. 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…

  2. 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. PMID:26568899

  3. 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

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

    PubMed

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

    2016-08-01

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

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

    PubMed Central

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

    2016-01-01

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

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

    PubMed Central

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

    2014-01-01

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

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

    PubMed Central

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

    2004-01-01

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

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

    PubMed

    Wong, Brian M; Holmboe, Eric S

    2016-04-01

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

  9. Clinical outcomes of transjugular intrahepatic portosystemic shunt for portal hypertension: Korean multicenter real-practice data

    PubMed Central

    Kim, Hyung Ki; Kim, Yoon Jun; Chung, Woo Jin; Kim, Soon Sun; Shim, Jae Jun; Choi, Moon Seok; Kim, Do Young; Jun, Dae Won; Um, Soon Ho; Park, Sung Jae; Woo, Hyun Young; Jung, Young Kul; Baik, Soon Koo; Kim, Moon Young; Park, Soo Young; Lee, Jae Myeong

    2014-01-01

    Background/Aims This retrospective study assessed the clinical outcome of a transjugular intrahepatic portosystemic shunt (TIPS) procedure for managing portal hypertension in Koreans with liver cirrhosis. Methods Between January 2003 and July 2013, 230 patients received a TIPS in 13 university-based hospitals. Results Of the 229 (99.6%) patients who successfully underwent TIPS placement, 142 received a TIPS for variceal bleeding, 84 for refractory ascites, and 3 for other indications. The follow-up period was 24.9±30.2 months (mean±SD), 74.7% of the stents were covered, and the primary patency rate at the 1-year follow-up was 78.7%. Hemorrhage occurred in 30 (21.1%) patients during follow-up; of these, 28 (93.3%) cases of rebleeding were associated with stent dysfunction. Fifty-four (23.6%) patients developed new hepatic encephalopathy, and most of these patients were successfully managed conservatively. The cumulative survival rates at 1, 6, 12, and 24 months were 87.5%, 75.0%, 66.8%, and 57.5%, respectively. A high Model for End-Stage Liver Disease (MELD) score was significantly associated with the risk of death within the first month after receiving a TIPS (P=0.018). Old age (P<0.001), indication for a TIPS (ascites vs. bleeding, P=0.005), low serum albumin (P<0.001), and high MELD score (P=0.006) were associated with overall mortality. Conclusions A high MELD score was found to be significantly associated with early and overall mortality rate in TIPS patients. Determining the appropriate indication is warranted to improve survival in these patients. PMID:24757655

  10. Clinical manifestations and outcome of patients with human immunodeficiency virus infection at tertiary care teaching hospital

    PubMed Central

    Patil, Virendra Chandrashekhar; Patil, Harsha V.

    2016-01-01

    Background: AIDS has become chronic illness which is well treated with antiretroviral therapy and management of opportunistic infections (OIs). Aims and Objectives: The study clinical profile and outcome of human immunodeficiency virus (HIV) seropositive patients. Materials and Methods: This was retrospective observational study carried out over a period of 1 year (January 2011–December 2011). All HIV patients admitted in medicine ward, and ICU were enrolled. Statistical analysis was performed using SSPE statistical software trial version 11. The P< 0.05 was considered as statistically significant. Results: Of total 111 patients with a diagnosis of HIV/AIDS, 75 (67.56%) were male and 36 (32.43%) were female patients. A total 52 (46.84%) patients presented with respiratory manifestations, of them 23 (44.23%) had pulmonary tuberculosis (TB), 6 (11.53%) had tubercular effusion, and 3 (5.76%) had Pneumocystis jirovecii pneumonia. Respiratory manifestations including pulmonary TB were the most common presentation (P< 0.001). Total 27 (24.32%) patients were presented with the neurological manifestation of them 8 (29.62%) had a cerebro-vascular accident, 5 (18.51%) had cryptococcal meningitis, 4 (14.81%) had tubercular meningitis, and 1 (3.70%) had progressive multifocal leukoencephalopathy. Total 12 (38.70%) had acute gastroenteritis 6 (19.35%) had oral candidiasis, 8 (25%) had general tonic clonic seizure and 7 (21.87%) had pyrexia of unknown origin, 6 (18.75%) had septicemia, 6 (18.75%) had acute renal failure, and 6 (94.11%) had anemia. A total 11 (9.90%) patients succumbed. Conclusions: Overall respiratory manifestations were the common presentation in a present cohort of HIV seropositive patients and TB was the most common OI and the cerebrovascular accident was the most common neurological manifestation. PMID:27190411

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

    ERIC Educational Resources Information Center

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

    2005-01-01

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

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

    ERIC Educational Resources Information Center

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

    2009-01-01

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

  13. Arterial Stiffening and Clinical Outcomes in Dialysis Patients.

    PubMed

    Kato, Akihiko

    2015-09-01

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

  14. Very poor outcome schizophrenia: Clinical and neuroimaging aspects

    PubMed Central

    Mitelman, Serge A.; Buchsbaum, Monte S.

    2009-01-01

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

  15. Five-year clinical outcomes of drug-eluting stents according to on-label and off-label use

    PubMed Central

    Park, Kyu-Hwan; Kim, Ung; Lee, Chan-Hee; Son, Jang-Won; Park, Jong-Seon; Shin, Dong-Gu; Kim, Young-Jo; Cho, Jeong-Hwan

    2016-01-01

    Background/Aims: To compare the clinical outcomes of ‘on-label’ and ‘off-label’ drug-eluting stents (DESs) over a 5-year follow-up period. Methods: A total of 929 patients that underwent percutaneous coronary intervention with DESs were enrolled. Patients were divided into two groups according to on-label (n = 449) and off-label (n = 480) indications. Off-label use was defined as implantation of DESs for acute myocardial infarction (MI), very small vessel, a long stenotic lesion, chronic total occlusion, a bifurcation lesion, an ostial lesion, left main coronary artery disease, multivessel disease, a saphenous vein graft lesion, and a lesion with thrombus. Endpoints were composite of major adverse cardiac events (MACEs), which included all-cause death, ischemic-driven target vessel revascularization (Id-TVR), MI, and stent thrombosis (ST). Clinical outcomes in the two groups were compared for up to 5 years postimplantation. Results: At 1 year postimplantation, the off-label group had higher incidences of total MACEs (8.2% vs. 3.7%, p = 0.005), Id-TVR (5.0% vs. 1.6%, p = 0.004), and ST (1.7% vs. 0.3%, p = 0.042), and at 5 years postimplantation, the off-label group continued to have higher incidences of total MACEs (17.5% vs. 9.4%, p < 0.001), Id-TVR (13.1% vs. 5.8%, p = 0.024), and ST (2.1% vs. 0.3%, p = 0.021). Multivessel disease and diabetes were found to be independent risk factors of MACE in patients with an off-label indication. Conclusions: Patients treated with an on-label DES had better long-term clinical outcomes than those treated with an off-label DES. PMID:27017384

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

    PubMed Central

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

    2013-01-01

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

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

    PubMed

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

    2016-03-01

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

  18. 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

  19. Clinical Outcomes of High Tibial Osteotomy for Knee Instability

    PubMed Central

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

    2016-01-01

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

  20. 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

  1. 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…

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

    PubMed

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

    2014-06-01

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

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

    PubMed

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

    2015-01-01

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

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

    PubMed

    Steensma, David P

    2016-01-01

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

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

    PubMed

    Kurbad, A

    2015-01-01

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

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

    PubMed

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

    2015-07-01

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

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

    PubMed Central

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

    2007-01-01

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

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

    PubMed

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

    2015-01-01

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

  9. Clinical Outcomes and Correlates of TP53 Mutations and Cancer

    PubMed Central

    Robles, Ana I.; Harris, Curtis C.

    2010-01-01

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

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

    PubMed

    Gatchel, R J; Maddrey, A M

    1998-09-01

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

  11. 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

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

    PubMed

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

    2015-07-01

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

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

    PubMed

    Song, Jessica C; Stevens, David A

    2016-09-01

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

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

    PubMed

    Krishna, Ranjitha; De Stefano, Jamie A

    2016-06-01

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

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

    PubMed

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

    2009-01-01

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

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

    PubMed Central

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

    2015-01-01

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

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

    PubMed

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

    2015-03-01

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

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

    PubMed Central

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

    2013-01-01

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

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

    PubMed

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

    2009-11-01

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

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

    PubMed

    Wilder, Rebecca S; Bray, Kimberly S

    2016-06-01

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

  1. Cholestatic hepatitis C following liver transplantation: an outcome-based histological definition, clinical predictors, and prognosis.

    PubMed

    Verna, Elizabeth C; Abdelmessih, Rita; Salomao, Marcela A; Lefkowitch, Jay; Moreira, Roger K; Brown, Robert S

    2013-01-01

    Cholestatic hepatitis C virus (HCV) is a rare form of recurrent HCV following liver transplantation (LT) without specific diagnostic criteria. An outcome-based method to improve its diagnosis and a description of its prognosis are needed. All 1-year post-LT protocol liver biopsy samples and biopsy samples initially reported to show cholestatic HCV from patients transplanted with HCV between February 2002 and December 2009 were reviewed for the inflammation grade, the fibrosis stage, and 4 cholestatic HCV features: ductular proliferation, canalicular cholestasis with or without intracellular cholestasis, hepatocyte swelling with or without lobular disarray, and sinusoidal/pericellular fibrosis. We used patient and graft survival to define histological criteria for cholestatic HCV, and compared the clinical features of these patients to those of patients with minimal or significant post-LT fibrosis. One hundred seventy-nine patients were analyzed, the median age was 56 years, and 73% were male. Patients with 3 or more of the 4 cholestatic HCV criteria had significantly worse survival (log-rank P < 0.001) regardless of the fibrosis stage, and this was used as our novel definition of cholestatic HCV. Using this definition, we found that 27 patients (15%) had cholestatic HCV, 53 (30%) had significant fibrosis (stage ≥ 2/4), and 99 (55%) had minimal fibrosis (stage < 2/4). The final model for clinical predictors of cholestatic HCV included donor age [odds ratio (OR) = 1.37 per decade, P = 0.04] and previous rejection (Banff grade ≥ 5; OR = 4.19, P = 0.002). Total bilirubin was the strongest laboratory predictor of cholestatic HCV (area under the curve = 0.93), whereas the HCV viral load was not a significant predictor. The final model of post-LT survival included the pathology group {cholestatic HCV [hazard ratio (HR) = 6.07, P < 0.001] and significant fibrosis (HR = 2.53, P = 0.02)}, donor age (HR = 1.49 per decade, P < 0.001), and cold ischemia time (HR = 1.11 per

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

    PubMed Central

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

    2003-01-01

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

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

    PubMed Central

    Seeto, R K; Rockey, D C

    1999-01-01

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

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

    PubMed Central

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

    2015-01-01

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

  5. 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.

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

    PubMed

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

    2014-01-01

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

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

    PubMed

    Chu, L C; Tung, W K

    2005-10-01

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

  8. Postoperative biological and clinical outcomes following uncomplicated pancreaticoduodenectomy

    PubMed Central

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

    2016-01-01

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

  9. 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

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

    PubMed

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

    2016-06-01

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

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

    PubMed

    Asl, Afshin Safaei; Maleknejad, Shohreh

    2012-05-01

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

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

    PubMed

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

    2016-08-01

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

  13. Stem Cell Transplantation as a Dynamical System: Are Clinical Outcomes Deterministic?

    PubMed Central

    Toor, Amir A.; Kobulnicky, Jared D.; Salman, Salman; Roberts, Catherine H.; Jameson-Lee, Max; Meier, Jeremy; Scalora, Allison; Sheth, Nihar; Koparde, Vishal; Serrano, Myrna; Buck, Gregory A.; Clark, William B.; McCarty, John M.; Chung, Harold M.; Manjili, Masoud H.; Sabo, Roy T.; Neale, Michael C.

    2014-01-01

    Outcomes in stem cell transplantation (SCT) are modeled using probability theory. However, the clinical course following SCT appears to demonstrate many characteristics of dynamical systems, especially when outcomes are considered in the context of immune reconstitution. Dynamical systems tend to evolve over time according to mathematically determined rules. Characteristically, the future states of the system are predicated on the states preceding them, and there is sensitivity to initial conditions. In SCT, the interaction between donor T cells and the recipient may be considered as such a system in which, graft source, conditioning, and early immunosuppression profoundly influence immune reconstitution over time. This eventually determines clinical outcomes, either the emergence of tolerance or the development of graft versus host disease. In this paper, parallels between SCT and dynamical systems are explored and a conceptual framework for developing mathematical models to understand disparate transplant outcomes is proposed. PMID:25520720

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

    PubMed

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

    2008-07-01

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

  15. Intradialytic Hypoxemia and Clinical Outcomes in Patients on Hemodialysis

    PubMed Central

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

    2016-01-01

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

  16. Improving Heart Failure Outcomes: The Role of the Clinical Nurse Specialist.

    PubMed

    Coen, Jennifer; Curry, Kimberly

    2016-01-01

    This article identifies and explains barriers to optimal outcomes of heart failure and the role of the clinical nurse specialist in overcoming these obstacles, improving patient outcomes and quality of life. In recent years, advances in heart failure management have increased survival rates, and as a result, the number of patients requiring services to manage disease progression and the complex array of symptoms associated with end-stage heart disease. Management of the heart failure patient is dependent on the severity of the disease and wide range of available treatment regimens. Disease progression can be unpredictable and treatment regimens increasingly complex. The authors present a typical case of a patient with heart failure, identify the barriers to optimal outcomes in managing heart failure, as well as describe the roles of the clinical nurse specialist in overcoming these barriers within 3 spheres of clinical nurse specialist influence: patient, health care provider, and health care systems. The clinical nurse specialist role is ideally suited to positively affect heart failure outcomes. These positive effects are drawn from the dynamic and unique nature of the clinical nurse specialist role and are perpetrated through the 3 spheres of clinical nurse specialist practice: patient, health care provider, and heath care system. PMID:27575796

  17. Clinical Outcome of First- vs Second-Generation DES According to DAPT Duration: Results of ARCTIC-Generation.

    PubMed

    Collet, Jean-Philippe; Silvain, Johanne; Kerneis, Mathieu; Cuisset, Thomas; Meneveau, Nicolas; Boueri, Ziad; Barthélémy, Olivier; Rangé, Grégoire; Cayla, Guillaume; Belle, Eric Van; Elhadad, Simon; Carrié, Didier; Caussin, Christophe; Rousseau, Hélène; Aubry, Pierre; Monségu, Jacques; Sabouret, Pierre; O'Connor, Stephen A; Abtan, Jérémie; Saint-Etienne, Christophe; Beygui, Farzin; Vicaut, Eric; Montalescot, Gilles

    2016-04-01

    There is an apparent benefit with extension of dual antiplatelet therapy (DAPT) beyond 1 year after implantation of drug-eluting stents (DES). Assessment by a Double Randomization of a Conventional Antiplatelet Strategy vs a Monitoring-Guided Strategy for Drug-Eluting Stent Implantation, and of Treatment Interruption vs Continuation One Year After Stenting (ARCTIC)-Generation assessed whether there is a difference of outcome between first- vs second-generation DES and if there is an interaction with DAPT duration in the ARCTIC-Interruption study. ARCTIC-Interruption randomly allocated 1259 patients 1 year after stent implantation to a strategy of interruption of DAPT (n = 624), in which aspirin antiplatelet treatment only was maintained, or DAPT continuation (n = 635) for 6 to 18 additional months. The primary endpoint was the composite of death, myocardial infarction, stent thrombosis, stroke, or urgent revascularization. A total of 520 and 722 patients received a first- and a second-generation DES, respectively. After a median follow-up of 17 months (interquartile range, 15-18 months) after randomization, the primary endpoint occurred in 32 (6.2%) and 19 (2.6%) patients with first- and second-generation DES, respectively (hazard ratio: 2.31, 95% confidence interval: 1.31-4.07, P = 0.004). This was observed irrespective of the strategy of interruption or continuation of DAPT and timing of study recruitment. Major bleeding events occurred in 4 (0.8%) and 3 patients (0.4%) with first- and second-generation DES, respectively (hazard ratio: 1.79, 95% confidence interval: 0.40-8.02, P = 0.44). Results did not change after multiple adjustments for potential confounding variables. ARCTIC-Generation showed worse clinical outcome with first- vs second-generation DES, a difference that appeared to persist even with prolonged DAPT. PMID:26880570

  18. 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

  19. IFN-gamma determines distinct clinical outcomes in autoimmune encephalomyelitis.

    PubMed

    Wensky, Allen K; Furtado, Glaucia C; Marcondes, Maria Cecilia Garibaldi; Chen, Shaohua; Manfra, Denise; Lira, Sergio A; Zagzag, David; Lafaille, Juan J

    2005-02-01

    Experimental autoimmune encephalomyelitis (EAE) is an inflammatory disease of the CNS initiated by autoreactive CD4(+) T cells. EAE classically presents with a progressive ascending paralysis and is a model of multiple sclerosis that recapitulates some aspects of the disease. In this report we describe a mouse strain that spontaneously develops a severe, nonclassical form of EAE with 100% incidence. The distinct clinical phenotype is marked initially by a slight head tilt, progressing to a severe head tilt, spinning, or a rotatory motion. Classical EAE spontaneously occurs in myelin basic protein (MBP)-specific TCR transgenic RAG-1(-/-) mice (referred to as T/R(-)), whereas nonclassical EAE spontaneously occurs in T/R(-) IFN-gamma(-/-) mice (T/R(-)gamma(-)). Thus, the TCR recognizes the same Ag (MBP) and uses identical TCR in both cases. The cellular infiltrate in nonclassical EAE is predominantly found in the brainstem and cerebellum, with very little inflammation in the spinal cord, which is primarily affected in classical disease. Importantly, depending on the genetic makeup and priming conditions of the MBP-specific T cells, nonclassical disease can occur in the presence of an inflammatory infiltrate with eosinophilic, neutrophilic, or monocytic characteristics. Finally, we believe that nonclassical spontaneous EAE could be a useful model for the study of some characteristics of multiple sclerosis not observed in classical EAE, such as the inflammatory responses in the brainstem and cerebellum that can cause vertigo. PMID:15661899

  20. 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

  1. Clinical Course and Outcomes of Late Kidney Allograft Dysfunction

    PubMed Central

    Zakharov, Vadym; Ksenofontova, Anna; Onishchenko, Eugene; Golubova, Tatyana; Kichatyi, Sergey; Zakharova, Olga

    2016-01-01

    Background. This study is provided to increase the efficiency of the treatment of kidney transplant recipients by predicting the development of the late allotransplant dysfunction. Methods. 330 patients who have lived for more than one year with functioning kidney allograft were evaluated. To predict the subsequent duration of the well-functioning of allotransplant the prognostic significance of 15 baseline clinical and sociodemographic characteristics on the results of the survey one year after transplantation was investigated. The result was considered to be positive in constructing the regression prognostication model if recipient lived more than 3 years from the time of transplantation. Results. It was established that more late start of renal allograft dysfunction after transplantation correlates with the more time it takes till complete loss of allograft function. Creatinine and hemoglobin blood concentration and the level of proteinuria one year after transplantation within created mathematical model allow predicting the loss of kidney transplant function three years after the transplantation. Patients with kidney transplant dysfunction are advised to renew the program hemodialysis upon reaching plasma creatinine concentration 0.5–0.7 mmol/L. Conclusion. Values of creatinine, hemoglobin, and proteinuria one year after transplantation can be used for subsequent prognostication of kidney transplant function. PMID:27478631

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

    PubMed

    Peterson, Sarah J; Braunschweig, Carol A

    2016-02-01

    Sarcopenia refers to age-associated decrease in muscle mass and function. The condition was originally described in the elderly, but emerging evidence suggests that it is also a concern among the chronically ill nonelderly. Currently there are a number of definitions for diagnosing sarcopenia; however, in the clinical setting, abdominal computed tomography (CT) scans completed for diagnostic purposes can be utilized to identify CT-defined sarcopenia. Recent studies suggest that prevalence of CT-defined sarcopenia is high among chronically ill patients, ranging from 15%-50% in patients with cancer, 30%-45% with liver failure, and 60%-70% for critically ill patients in the intensive care unit. Depleted muscle mass is associated with infectious complications, prolonged duration of mechanical ventilation, longer hospitalization, greater need for rehabilitation care after hospital discharge, and higher mortality. In consideration of the growing population of older adults with multiple comorbidities, more research is needed to identify sarcopenia and develop interventions that are directed at attenuating or reversal muscle loss. PMID:26703961

  3. Clinical outcomes of suture delay in forehead flap.

    PubMed

    Isik, Daghan; Kiroglu, Faruk; Isik, Yasemin; Goktas, Ugur; Atik, Bekir

    2012-01-01

    The delay phenomenon is a surgical procedure performed to raise a wider skin flap and to improve the survival of skin flaps. Surgery, chemicals, sutures, and lasers can be used for the delay procedure. In this study, delayed forehead flaps created by suturing were used for coverage of nasal skin defects in eleven patients. In 7 patients, the cross-paramedian forehead flap was used to increase the extent of flap lengthening. In the first session, suture delay was performed on both sides of the forehead flap margin. In the second session, the flap was elevated and sutured to its new position, 7 to 10 days after the initial surgery. All flaps were completely viable, and patient satisfaction was optimal in all cases. The positive effect of surgical delay on flap survival has been shown in experimental and clinical studies. However, experimentally, suture delay or chemical delay procedures have been shown to be beneficial in flap survival only. Suture delay seems to be an inexpensive, effective, easily performed, atraumatic, and safe technique, especially among patients with systemic diseases such as diabetes or cardiovascular diseases, smoking patients who may lose the flap, or patients who need very wide and long flaps. PMID:22337378

  4. Can adventurous training have a role in improving clinical outcomes?

    PubMed

    Mellor, A; Jackson, S; Hardern, R

    2012-06-01

    The aim of military adventurous training (AT) is "to develop, through authorised challenging pursuits and within an outdoor environment, leadership and the qualities necessary to enhance the performance of military personnel during peace and war". An increasing amount of effort is being applied by all three services to increase participation in AT to achieve these, largely immeasurable, aims. Existing guidance to Commanding Officers dictates that, where possible, 20% of a unit strength should undertake some form of AT annually with 5% taking part in an overseas expedition. In a speech in 2008 Alan Johnson, the then Secretary of State for Health, acknowledged that for Armed Forces medical personnel 'just as important as clinical skills are issues such as leadership, communication, adaptability and teamwork." Controlled exposure to risk, discomfort and personal hardship is a common theme for both AT activities and military deployments. Both General Medical Council competencies for all doctors and the Royal College of Anaesthetists military module include elements which can effectively be taught and developed through training in an outdoors environment. These skills include communication skills, leadership, risk assessment and interdisciplinary working. In this review the value of AT in training doctors to develop those attributes is examined. PMID:22860500

  5. 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

  6. Effectiveness of structured hourly nurse rounding on patient satisfaction and clinical outcomes.

    PubMed

    Brosey, Lisa A; March, Karen S

    2015-01-01

    Structured hourly nurse rounding is an effective method to improve patient satisfaction and clinical outcomes. This program evaluation describes outcomes related to the implementation of hourly nurse rounding in one medical-surgical unit in a large community hospital. Overall Hospital Consumer Assessment of Healthcare Providers and Systems domain scores increased with the exception of responsiveness of staff. Patient falls and hospital-acquired pressure ulcers decreased during the project period. PMID:25237791

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

    PubMed

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

    2016-10-01

    The incidence of lower gastrointestinal bleeding (LGIB) is increasing; however, predictors of outcomes for patients with LGIB are not as well defined as those for patients with upper gastrointestinal bleeding (UGIB). The aim of this study was to identify the clinical outcomes and the predictors of poor outcomes for patients with LGIB, compared to outcomes for patients with UGIB. We identified patients with LGIB or UGIB who underwent endoscopic procedures between July 2006 and February 2013. Propensity score matching was used to improve comparability between LGIB and UGIB groups. The clinical outcomes and predictors of 30-day rebleeding and mortality rate were analyzed between the two groups. In total, 601 patients with UGIB (n = 500) or LGIB (n = 101) were included in the study, and 202 patients with UGIB and 101 patients with LGIB were analyzed after 2:1 propensity score matching. The 30-day rebleeding and mortality rates were 9.9% and 4.5% for the UGIB group, and 16.8% and 5.0% for LGIB group, respectively. After logistic regression analysis, the Rockall score (P = 0.013) and C-reactive protein (CRP; P = 0.047) levels were significant predictors of 30-day mortality in patients with LGIB; however, we could not identify any predictors of rebleeding in patients with LGIB. The clinical outcomes for patients with LGIB are not better than clinical outcomes for patients with UGIB. The clinical Rockall score and serum CRP levels may be used to predict 30-day mortality in patients with LGIB. PMID:27550490

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

    PubMed

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

    2016-06-01

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

  9. 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

  10. Collaboration in research: testing the PIPC model on clinical and nonclinical outcomes.

    PubMed

    Lengacher, C A; Mabe, P R; Heinemann, D; VanCott, M L; Kent, K; Swymer, S

    1997-01-01

    This outcomes research used a collaborative framework between a college of nursing and a medical center to test the effects of the Partners in Patient Care delivery model (PIPC) on clinical and nonclinical outcomes. An experimental pretest-postest design was used to compare selected nonclinical outcomes and clinical outcomes of care in two patient units. Results showed that there were significant differences between units in the nonclinical outcomes of nurse satisfaction, salary costs, supply costs, and productivity as measured by documentation time. In addition, there were significant differences in the clinical outcomes of care in terms of patient satisfaction. No significant differences were found in number of falls, medication errors, and intravenous infections; however, when ratios of these indicators were examined in relation to patient days, significant differences in the medication error ratio and the fall ratio were revealed. The results indicate that the PIPC delivery model did have positive effects on patient satisfaction and nurse satisfaction but that there were increased costs and increased time spent in documentation on the pilot unit. PMID:9171689

  11. Splenic abscess: clinical features, microbiologic finding, treatment and outcome.

    PubMed

    Sangchan, Apichat; Mootsikapun, Piroon; Mairiang, Pisaln

    2003-05-01

    Splenic abscess is a rare clinical entity but may be underreported. A retrospective study at Srinagarind Hospital revealed 60 cases of splenic abscess between 1992 and 2001. The causative organisms were identified in 41 cases (68.3%). Gram negative bacilli were commonly isolated and Burkholderia pseudomallei was the most predominant. Diabetes mellitus and leukemia were common underlying diseases found in 46.3 per cent and 9.7 per cent of culture confirmed cases, respectively. The patients usually presented with fever, left upper quadrant pain, tenderness and splenomegaly. Multiple abscesses were more commonly found in the melioidosis than in the non-melioidosis group (p = 0.032), but a single abscess was more commonly found in the non-melioidosis than in the melioidosis group (p = 0.032). Concurrent liver abscesses, often multiple, were not different in both groups. Antimicrobials alone were given in 66.7 per cent of cases with melioidosis and 64.7 per cent of non-melioidosis group. Splenectomy and percutaneous aspiration were performed only in 29.3 per cent and 4.9 per cent of cases with splenic abscess. The overall mortality rate of splenic abscess was only 4.9 per cent in the present series. In conclusion, splenic abscess is not uncommon. Burkholderia pseudomalleli is the most common causative agent found in the present series. Therefore, it should be targeted in the initial empirical antibiotic therapy before the culture results are available especially when multiple lesions in the spleen and concurrent multiple liver abscesses are seen. Prolonged treatment with appropriate antimicrobials alone is usually effective. Splenectomy and/or aspiration may be useful in selected patients. PMID:12859100

  12. Bilateral Chronic Subdural Hematoma is Associated with Rapid Progression and Poor Clinical Outcome

    PubMed Central

    AGAWA, Yuji; MINEHARU, Yohei; TANI, Shoichi; ADACHI, Hidemitsu; IMAMURA, Hirotoshi; SAKAI, Nobuyuki

    2016-01-01

    Chronic subdural hematoma (CSDH) has been recognized as a benign disease, but its clinical outcome is not well documented. This study aims to expand the knowledge base regarding the outcome of CSDH. We retrospectively reviewed clinical characteristics of CSDH operated in the Kobe City Medical Center General Hospital between June 2005 and June 2012. Variants included age at onset, sex, laterality, presence of headache, consciousness level, and risk factors for hemorrhage such as malignancy or intake of anticoagulants. A total of 368 cases were analyzed. Six patients (1.4%) had a poor outcome, defined as any morbidity or mortality at 7 days postoperatively. Bilateral hematoma was significantly associated with a poor outcome (p = 0.041). Warfarin use and malignancy, albeit statistically not significant, were more frequently observed in patients with a poor outcome. Bilateral CSDH was observed in 53 patients (14.4%). Age at onset, sex, history of malignancy, anticoagulant use, and antiplatelet use did not differ between bilateral and unilateral CSDH. Recurrence rate was not different between bilateral and unilateral CSDH (14.2% vs. 11.3%), but poor outcome as a result of brain herniation was significantly higher in bilateral than in unilateral hematomas (5.7% vs. 0.3%, p = 0.01). Bilateral CSDH was associated with rapid progression and showed worse outcome as a result of brain herniation in comparison with unilateral CSDH. Urgent trephination surgery for decompression of hematoma pressure may be recommended for bilateral CSDH. PMID:26923835

  13. Feasibility and Clinical Outcomes of Peripheral Drug-Coated Balloon in High-Risk Patients with Femoropopliteal Disease

    PubMed Central

    Huang, Hsuan-Li; Juang, Jyh-Ming Jimmy; Chou, Hsin-Hua; Tsao, Chueh-Yung; Wu, Tien-Yu; Ko, Yu-Lin

    2015-01-01

    Background Clinical outcomes of the drug-coated balloon (DCB) procedure in high-risk patients with femoropopliteal (FP) disease have not been investigated sufficiently. Methods This retrospective, single-center study analyzed 87 patients (39% dialysis) and 97 affected legs (64% critical limb ischemia [CLI]) that underwent DCB for symptomatic FP disease from March 2013 to September 2014. Risk stratification was based on FeDCLIP (female, diabetes, dialysis, CLI, lesion length >150 mm and poor runoff) score. The DCB outcomes among the different risk groups were compared and factors predicting restenosis were analyzed during follow-up. Results Most of study participants (84%) were moderate to high-risk patients. The procedural success rate was 100% and the 30-day major adverse vascular event rate was 2.1%. The mean lesion length was 178 ± 106 mm and the mean follow-up time was 428 ± 145 (range 50–782) days. The binary restenosis-free and clinically driven target lesion revascularization (CD-TLR)-free rates at 12 months were 77.5% and 84.3%, respectively, for all participants. No significant differences were observed in 1-year binary restenosis and CD-TLR rates in the low-, moderate-, and high-risk groups (60%, 84%, and 73%: p = 0.396; 78%, 89%, and 80%: p = 0.635, respectively). In multivariate analysis, lesion length >150 mm (Hazard ratio [HR]: 8.00, 95% confidence interval (CI) 1.12 to 55.6, p = 0.038) and Rutherford class 6 (HR: 7.09, 95% CI, 1.15 to 43.5, p = 0.034) were identified as independent predictors of binary restenosis. Conclusions Despite general comorbidities and advanced limb ischemia, 1-year outcomes of DCB in high-risk patients with FP disease were effective. The DCB procedure holds promise to improve vessel patency; however, lesion length >150 mm and major tissue loss were independent predictors for binary restenosis after the treatment. PMID:26599128

  14. A Personalized BEST: Characterization of Latent Clinical Classes of Nonischemic Heart Failure That Predict Outcomes and Response to Bucindolol

    PubMed Central

    Kao, David P.; Wagner, Brandie D.; Robertson, Alastair D.; Bristow, Michael R.; Lowes, Brian D.

    2012-01-01

    Background Heart failure patients with reduced ejection fraction (HFREF) are heterogenous, and our ability to identify patients likely to respond to therapy is limited. We present a method of identifying disease subtypes using high-dimensional clinical phenotyping and latent class analysis that may be useful in personalizing prognosis and treatment in HFREF. Methods A total of 1121 patients with nonischemic HFREF from the β-blocker Evaluation of Survival Trial were categorized according to 27 clinical features. Latent class analysis was used to generate two latent class models, LCM A and B, to identify HFREF subtypes. LCM A consisted of features associated with HF pathogenesis, whereas LCM B consisted of markers of HF progression and severity. The Seattle Heart Failure Model (SHFM) Score was also calculated for all patients. Mortality, improvement in left ventricular ejection fraction (LVEF) defined as an increase in LVEF ≥5% and a final LVEF of 35% after 12 months, and effect of bucindolol on both outcomes were compared across HFREF subtypes. Performance of models that included a combination of LCM subtypes and SHFM scores towards predicting mortality and LVEF response was estimated and subsequently validated using leave-one-out cross-validation and data from the Multicenter Oral Carvedilol Heart Failure Assessment Trial. Results A total of 6 subtypes were identified using LCM A and 5 subtypes using LCM B. Several subtypes resembled familiar clinical phenotypes. Prognosis, improvement in LVEF, and the effect of bucindolol treatment differed significantly between subtypes. Prediction improved with addition of both latent class models to SHFM for both 1-year mortality and LVEF response outcomes. Conclusions The combination of high-dimensional phenotyping and latent class analysis identifies subtypes of HFREF with implications for prognosis and response to specific therapies that may provide insight into mechanisms of disease. These subtypes may facilitate

  15. Evaluation of NOC standardized outcome of "health seeking behavior" in nurse-managed clinics.

    PubMed

    Macnee, Carol L; Edwards, Joellen; Kaplan, Amy; Reed, Sue; Bradford, Susanne; Walls, Jennie; Schaller-Ayers, Jennifer M

    2006-01-01

    This study evaluated the accomplishment of the Nursing Outcomes Classification (NOC) outcome "Health Seeking Behavior" in 5 nurse-managed clinics. Nurse practitioners and registered nurses rated patients on 11 indicators of health seeking behaviors, and recorded their level of knowledge of the patient. A total of 556 evaluations were collected. Health seeking behavior scores were lowest in a rural county school-based clinic and highest in a federally qualified health center. Ratings increased with nurses' knowledge of patients and for older patients. PMID:16816605

  16. 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.

  17. Recipient Hyperbilirubinemia May Reduce Ischemia-Reperfusion Injury but Fails to Improve Outcome in Clinical Liver Transplantation

    PubMed Central

    Oltean, Mihai; Barrenäs, Christian; Martins, Paulo Ney; Herlenius, Gustaf; Gustafsson, Bengt; Friman, Styrbjörn; Bennet, William

    2016-01-01

    Background. Exogenous bilirubin may reduce experimental ischemia-reperfusion injury (IRI) due to its antioxidant properties. We studied if early graft exposure to high bilirubin levels in the recipient affects the early IRI and outcomes after liver transplantation (LTx). Methods. In 427 LTx patients, the AUROC curve based on bilirubin and AST at day 1 identified a cutoff of 2.04 mg/dL for the recipient pretransplant bilirubin. Recipients were grouped as having low (group L, n = 152) or high (group H, n = 275) bilirubin. Both groups had similar donor-related variables (age, preservation time, donor BMI > 28, and donor risk index (DRI)). Results. Alanine (ALT) and aspartate (AST) aminotransferase levels were higher in group L at day 1; ALT levels remained higher at day 2 in group L. LTx from high risk donors (DRI > 2) revealed a trend towards lower transaminases during the first two days after transplantation in group H. One month and 1-year patient survival were similar in groups L and H. High preoperative bilirubin did not affect the risk for early graft dysfunction (EGD), death, or graft loss during the first year after transplantation nor the incidence of acute rejection. LTx using donors with DRI > 2 resulted in similar rates of EGD in both groups. Conclusion. Increased bilirubin appears to reduce the early IRI after LTx yet this improvement was insufficient to improve the clinical outcome.

  18. Clinical Presentation, Management and Outcome of Acute Coronary Syndrome in Yemen: Data from GULF RACE - 2 Registry

    PubMed Central

    Ahmed, Al-Motarreb; Abdulwahab, Al-Matry; Hesham, Al-Fakih; Nawar, Wather

    2013-01-01

    Background: Acute Coronary Syndrome (ACS) is increasing in Yemen in recent years and there are no data available on its short and long-term outcome. We evaluated the clinical pictures, management, in-hospital, and long-term outcomes of the ACS patients in Yemen. Design and Setting: A 9-month prospective, multi-center study conducted in 26 hospitals from 9 governorates. The study included 30-day and 1-year mortality follow-up. Patients and Methods: One thousand seven hundred and sixty one patients with ACS were collected prospectively during the 9-month period. Patients with ST-elevation myocardial infarction (STEMI) and non-ST-elevation acute coronary syndrome (NSTEACS), including non-ST-elevation myocardial infarction and unstable angina were included. Conclusions: ACS patients in Yemen present at a relatively young age with high prevalence of Smoking, khat chewing and hypertension. STEMI patients present late, and their acute management is poor. In-hospital evidence-based medication rates are high, but coronary revascularization procedures were very low. In-hospital mortality was high and long-term mortality rates increased two folds compared with the in-hospital mortality. PMID:24695681

  19. Clinical relevance vs. statistical significance: Using neck outcomes in patients with temporomandibular disorders as an example.

    PubMed

    Armijo-Olivo, Susan; Warren, Sharon; Fuentes, Jorge; Magee, David J

    2011-12-01

    Statistical significance has been used extensively to evaluate the results of research studies. Nevertheless, it offers only limited information to clinicians. The assessment of clinical relevance can facilitate the interpretation of the research results into clinical practice. The objective of this study was to explore different methods to evaluate the clinical relevance of the results using a cross-sectional study as an example comparing different neck outcomes between subjects with temporomandibular disorders and healthy controls. Subjects were compared for head and cervical posture, maximal cervical muscle strength, endurance of the cervical flexor and extensor muscles, and electromyographic activity of the cervical flexor muscles during the CranioCervical Flexion Test (CCFT). The evaluation of clinical relevance of the results was performed based on the effect size (ES), minimal important difference (MID), and clinical judgement. The results of this study show that it is possible to have statistical significance without having clinical relevance, to have both statistical significance and clinical relevance, to have clinical relevance without having statistical significance, or to have neither statistical significance nor clinical relevance. The evaluation of clinical relevance in clinical research is crucial to simplify the transfer of knowledge from research into practice. Clinical researchers should present the clinical relevance of their results. PMID:21658987

  20. 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

  1. Evaluation of the Outcome-Present State Test Model as a way to teach clinical reasoning.

    PubMed

    Bartlett, Robin; Bland, Ann; Rossen, Eileen; Kautz, Donald; Benfield, Susan; Carnevale, Teresa

    2008-08-01

    The Outcome-Present State Test (OPT) Model of Clinical Reasoning is a nursing process model designed to help students develop clinical reasoning skills. Although many nurse educators are using the OPT model as a teaching strategy, few are formally evaluating its use as a method. We used the OPT model as a teaching tool in an undergraduate psychiatric and mental health clinical nursing course and evaluated how quickly students became adept at using it. Most students mastered the use of the model; 29 of 43 students achieved the criterion score (a score greater than 65 on 3 or more models completed over 4 weeks). Not only did the students gain clinical reasoning skills, but they also used and learned more about the North American Nursing Diagnosis Association, Nursing Interventions Classification, and Nursing Outcomes Classification languages. Recommendations for future use of the model include adding client strengths and increasing focus on the quality of students' responses. PMID:18751647

  2. Is the Perinatal Outcome of Placental Abruption Modified by Clinical Presentation?

    PubMed Central

    Furukawa, Seishi; Sameshima, Hiroshi; Ikenoue, Tsuyomu; Ohashi, Masanao; Nagai, Yoshio

    2011-01-01

    Objective. The purpose of this study was to elucidate the impact of the clinical presentation on perinatal outcome in placental abruption. Study Design. A retrospective study was performed in 97 placental abruptions. Placental abruptions were classified according to clinical presentation: pregnancy-induced hypertension (HT, n = 22), threatened premature labor and/or premature rupture of membranes (TPL/ROM, n = 35), clinically low risk (LR, n = 27), and others (n = 13). Perinatal outcomes were compared among the HT, TPL/ROM, and LR groups. Results. The HT had significantly higher incidence of IUGR, IFUD, and low fibrinogen. The TPL/ROM had less severe disease. However, the LR had significantly higher incidence of IUFD, low UA pH < 7.1, low Apgar score of <7 at 5 min, and low fibrinogen. Conclusion. Disease severity in placental abruption is likely to depend on the clinical presentation. PMID:21490793

  3. Beyond the "acid test": a conceptual review and reformulation of outcome evaluation in clinical supervision.

    PubMed

    Milne, Derek

    2014-01-01

    Theoretical models abound within clinical supervision, but these rarely have been applied to supervision evaluation. Instead, it appears that reviewers and researchers have simply transferred to supervision the conceptual frameworks used within medicine, especially the idea that clinical outcomes are the "acid test" of supervisory effectiveness or quality. Following a careful examination of the key literature, in this paper I argue that this has led to an over-emphasis on clinical outcomes, with the net effect of reducing scientific confidence, understanding, and the effectiveness of supervision. To begin to rectify this bias, an augmented fidelity framework is used to reformulate evaluation, drawing on some of the key concepts guiding evaluation within related fields (i.e. service evaluation; staff development; psychotherapy; applied research). The resulting evaluation model is specific to clinical supervision and can help to increase our understanding, enhance our practice, re-prioritise research, and inspire confidence in supervision. PMID:25122986

  4. Nursing home-acquired pneumonia: outcomes from a clinical process improvement program.

    PubMed

    Dempsey, C L

    1995-01-01

    At EHS Christ Hospital and Medical Center, an eight-step process improvement model was developed that incorporates continuous quality improvement concepts for monitoring, evaluating and improving patient care. Nursing home residents admitted with pneumonia were identified as the group having the most influence on mortality and costs associated with treatment of pneumonia at our hospital. A multidisciplinary team evaluated clinical resource use and patient care processes, and identified root causes of various influencing treatment. Clinical guidelines were created and outcomes were defined, resulting in significant improvement in the clinical management of these patients. Average length of stay decreased from 8.6 days in 1992 to 7.6 days in 1993, with a charge reduction of $1830 per patient. The methodologic framework of a process improvement program combines epidemiologic, clinical, and quality improvement sciences. This mix is essential in improving patient care and quantifying outcomes. PMID:7753691

  5. Clinical outcome of patients treated with spinal cord stimulation for therapeutically refractory angina pectoris

    PubMed Central

    TenVaarwerk, I; Jessurun, G; DeJongste, M; Andersen, C; Mannheimer, C; Eliasson, T; Tadema, W; Staal, M

    1999-01-01

    OBJECTIVE—To determine morbidity and mortality characteristics in patients treated with electrical neuromodulation for refractory angina pectoris.
DESIGN—A retrospective multicentre study of patients treated with spinal cord stimulation between 1987 and 1997; 21 centres were contacted and 14 responded.
SETTING—Specialist centres worldwide.
PATIENTS—Questionnaires were returned on 517 patients, of whom 71% were male. One was lost to follow up. Mean (SD) age was 63.9 (10.1) years. Duration of angina pectoris was 8.1 (6.3) years.
RESULTS—Before spinal cord stimulation, 66% of the patients had experienced myocardial infarction, 68% had three vessel disease, and in 24% the left ventricular ejection fraction (LVEF) was ⩽ 40%. Percutaneous transluminal coronary angioplasty and bypass surgery were performed in 17% and 58% of the subjects, respectively. During a median follow up of 23 months (range 0 to 128), 103 patients died (52 from a cardiac cause, 25 from a non-cardiac cause, and 26 from an unknown cause). Annual all cause mortality was 7-8%; annual cardiovascular fatality was 3.5-5%. Mortality was univariately related to sex, number of diseased vessels, number of revascularisation procedures, previous myocardial infarction, LVEF, insulin dependent diabetes, β blocking agents, and angiotensin converting enzyme inhibitors. Multiple variate analysis showed that LVEF, sex, β blockers, and age ⩾ 71 years were independent predictors of mortality. During spinal cord stimulation, New York Heart Association functional class improved from 3.5 to 2.1 (p < 0.01); 25 of the deceased patients (24%) and 32 survivors (8%) experienced myocardial infarction; hospital admissions were significantly (p < 0.001) more common in the deceased group (66% v 37%).
CONCLUSIONS—The clinical outcome of patients with intractable angina is not adversely affected by the chronic use of neurostimulation.


Keywords: angina pectoris; spinal cord

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

    PubMed Central

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

    2016-01-01

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

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

    PubMed Central

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

    2011-01-01

    This paper outlines the clinical application of CBCT for assessment of treatment outcomes, and discusses current work to superimpose digital dental models and 3D photographs. Superimposition of CBCTs on stable structures of reference now allow assessment of 3D dental, skeletal and soft tissue changes for both growing and non-growing patients. Additionally, we describe clinical findings from CBCT superimpositions in assessment of surgery and skeletal anchorage treatment. PMID:21516170

  8. Relationship between Lesion Topology and Clinical Outcome In Anterior Circulation Large Vessel Occlusions

    PubMed Central

    Rangaraju, Srikant; Streib, Christopher; Aghaebrahim, Amin; Jadhav, Ashutosh; Frankel, Michael; Jovin, Tudor G.

    2015-01-01

    Background and purpose Diffusion-weighted imaging (DWI) ASPECTS, a surrogate of infarct volume, predicts outcome in anterior large vessel occlusion (LVO) strokes. We aim to determine whether topological information captured by DWI ASPECTS contributes additional prognostic value. Methods Adults with intracranial ICA, M1 or M2 MCA occlusions who underwent endovascular therapy were included. The primary outcome measure was poor clinical outcome (3-month modified Rankin Scale score 3–6). Prognostic value of the 10 DWI ASPECTS regions in predicting poor outcome was determined by multivariable logistic regression, controlling for final infarct volume, age and laterality. Results 213 patients (mean age 66.1±14.5 years, median NIHSS 15) were included. Inter-rater reliability was good for DWI ASPECTS (Deep regions: Kappa=0.72, Cortical regions: Kappa=0.63). All DWI ASPECTS regions with the exception of the putamen were significant predictors (p<0.05) of poor outcome in univariate analyses. Statistical collinearity among ASPECTS regions was not observed. Using penalized multivariable logistic regression, only M4 (OR=2.82 95%CI 1.39–5.76) and M6 (OR=2.45, 95%CI 1.15–5.3) involvement were associated with poor outcome. M6 involvement independently predicted poor outcome in right hemispheric strokes (OR=5.8, 95%CI 1.9–20.3) whereas M4 (OR=4.3, 95%CI 1.3–15.0) involvement predicted poor outcome in left hemispheric strokes adjusting for infarct volume. Topologic information modestly improved the predictive ability of a prognostic score that incorporates age, infarct volume and hemorrhagic transformation. Conclusions Involvement of the right parieto-occipital (M6) and left superior-frontal (M4) regions impact clinical outcome in anterior LVOs over and above the effect of infarct volume and should be considered during prognostication. PMID:26060248

  9. Severe hypoxaemia can predict unfavourable clinical outcomes in individuals with pulmonary embolism aged over 40 years

    PubMed Central

    Souza, Caio Simoes; Resende, Fernanda Simoes Seabra; Rodrigues, Marcelo Palmeira

    2014-01-01

    INTRODUCTION Acute pulmonary embolism (APE) is an urgent clinical condition that can progress in a wide variety of ways. Therefore, we sought to develop an easy-to-apply algorithm, to be based on readily available clinical indicators, effective in predicting unfavourable outcomes. METHODS This was a retrospective cohort study based on systematically collected data in a database. The study included 102 patients with APE who were admitted to a tertiary care hospital. The following outcomes were defined as unfavourable shock, the need for mechanical ventilation, the use of thrombolytics, and death. Logistic regression analysis was used to explore variables significantly associated with outcome and to calculate post-test probabilities. RESULTS The prevalence of unfavourable outcomes was 25.5% (26 of the 102 patients with APE). The risk of an unfavourable outcome was reduced to 7.0% for patients with APE who were aged ≤ 40 years. In patients with APE who were aged > 40 years, the presence of hypoxaemia (i.e. peripheral oxygen saturation < 90%) alone increased the risk of an unfavourable outcome to 57.0%. A recent history of trauma and the presence of pre-existing lung or heart disease were significantly associated with unfavourable outcomes. The inclusion of those variables in the logistic regression model increased the post-test risk of an unfavourable outcome to 65.0%–86.0%. CONCLUSION Advanced age (i.e. > 40 years), the presence of hypoxaemia, a recent history of trauma and the presence of pre-existing lung or heart disease are risk factors for unfavourable outcome in patients with APE. PMID:25273933

  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. An assessment of HIV treatment outcomes among utilizers of semi-mobile clinics in rural Kenya.

    PubMed

    Gorman, Sara E; Martinez, Jose M; Olson, Jennifer

    2015-01-01

    HIV/AIDS is a major cause of morbidity and mortality in Africa, and rates of retention in treatment are low. Some research has shown that mobile clinics are effective in connecting people in rural areas with health care. We compared HIV outcomes between HIV-positive patients who chose to access treatment from a regional hospital to those who chose care in one of four semi-mobile clinics closer to where they live. The subjects for this analysis were HIV-positive residents in West Pokot accessing care at one of four semi-mobile sites (Kabichbich, Chepareria, Kacheliba, and Sigor) or at the regional hospital in Kapenguria. We examined four outcome variables between the two groups: (1) retention in HIV treatment, (2) change in CD4 count, (3) adherence to ARVs, and (4) deaths. The patients who chose semi-mobile clinic care were less well educated, poorer, and sicker than those who chose to continue care in the regional hospital. There were no statistically significant differences between the groups in any of the four outcome measures. Although the population of patients attending semi-mobile clinics was on average poorer and sicker than those attending the hospital, their outcomes were similar. Care at the semi-mobile clinics did not result in significantly different outcomes from care in the district hospital. This program showed that semi-mobile clinics are a viable alternative to hospital care for very ill, isolated populations, but further measures must be taken to improve retention and adherence in these settings. PMID:25495796

  12. Is Toxoplasma gondii type related to clinical outcome in human congenital infection? Systematic and critical review.

    PubMed

    Rico-Torres, C P; Vargas-Villavicencio, J A; Correa, D

    2016-07-01

    In human congenital toxoplasmosis the effects of parasite burden and pregnancy time at infection on clinical outcome are well known, but there is controversy regarding the role of Toxoplasma gondii type. Through a systematic review of the literature, we aimed to discern if T. gondii type has a role on clinical outcome in human congenital toxoplasmosis. We built up a database of congenital toxoplasmosis from reports of cases, case series and screening-based cohorts, which had information about parasite type, gestation time at maternal infection and/or clinical outcome in the product. Then, we obtained frequencies for loci used to genotype geographical origin of cases and types found. Also, odds ratios were calculated for association between time of maternal infection or parasite type on outcome. Type II parasites were the most common in Europe, Asia and Africa, while in America there were mainly atypical strains. More newborns with clinical problems were born from mothers infected during the first half of gestation than from those acquiring the parasite after week 24, regardless of parasite genotype (92.9 vs. 16.1 %, OR = 67.9, CI95 25.4-181.6). Type I and atypical parasites were associated with clinical problems as opposed to types II and III, regardless of pregnancy period at infection (86.9 vs. 72.9 %, OR = 2.47, CI95 1.1-5.4). A significant and remarkable tendency of type I parasites to be present during early pregnancy was also observed (94.4 vs. 5.6 %, P < 0.009). In addition to parasite burden and period of gestation, T. gondii genotype seems involved in CT clinical outcome. PMID:27146878

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

    PubMed Central

    2013-01-01

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

  14. 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.

  15. Live Birth is the Correct Outcome for Clinical Trials Evaluating Therapy for the Infertile Couple

    PubMed Central

    Barnhart, Kurt T.

    2014-01-01

    Well-designed and conducted clinical trials are needed to further advance the field for reproductive medicine. However current reporting of outcomes of trials is ambiguous and disparate. In this manuscript it is offed that the preferred outcome for clinical trials in reproductive medicine should be live birth. Multiple births should be listed and it should be specified whether this is multiple births per couple or multiple births per conception. The unit of measure should be women (or couples) and not cycles. The duration of exposure should also be clearly identified (i.e., treatment was one cycle, a pre-specified number of cycles, or a period of time). Pregnancy loss should be specified and the denominator should be those who conceived. While live birth is the primary outcome, complications should be defined and reported including multiple births and other objective markers such as preterm delivery, small-for-gestational age, or stillbirth. PMID:24786740

  16. Mechanical thrombectomy in pediatric acute ischemic stroke: Clinical outcomes and literature review.

    PubMed

    Madaelil, Thomas P; Kansagra, Akash P; Cross, DeWitte T; Moran, Christopher J; Derdeyn, Colin P

    2016-08-01

    There are limited data on outcomes of mechanical thrombectomy for pediatric stroke using modern devices. In this study, we report two cases of pediatric acute ischemic stroke treated with mechanical thrombectomy, both with good angiographic result (TICI 3) and clinical outcome (no neurological deficits at 90 days). In addition, we conducted a literature review of all previously reported cases describing the use of modern thrombectomy devices. Including our two cases, the aggregate rate of partial or complete vessel recanalization was 100% (22/22), and the aggregate rate of favorable clinical outcome was 91% (20/22). This preliminary evidence suggests that mechanical thrombectomy with modern devices may be a safe and effective treatment option in pediatric patients with acute ischemic stroke. PMID:26945589

  17. Craniotomy or Decompressive Craniectomy for Acute Subdural Hematomas: Surgical Selection and Clinical Outcome

    PubMed Central

    Kwon, Young Sub; Yang, Kook Hee

    2016-01-01

    Objective Craniotomy (CO) and decompressive craniectomy (DC) are two main surgical options for acute subdural hematomas (ASDH). However, optimal selection of surgical modality is unclear and decision may vary with surgeon's experience. To clarify this point, we analyzed preoperative findings and surgical outcome of patients with ASDH treated with CO or DC. Methods From January 2010 to December 2014, data for 46 patients with ASDH who underwent CO or DC were retrospectively reviewed. The demographic, clinical, imaging and clinical outcomes were analyzed and statistically compared. Results Twenty (43%) patients underwent CO and 26 (57%) patients received DC. In DC group, preoperative Glascow Coma Scale was lower (p=0.034), and more patient had non-reactive pupil (p=0.004). Computed tomography findings of DC group showed more frequent subarachnoid hemorrhage (p=0.003). Six month modified Rankin Scale showed favorable outcome in 60% of CO group and 23% of DC group (p=0.004). DC was done in patient with more unfavorable preoperative features (p=0.017). Patients with few unfavorable preoperative features (<6) had good outcome with CO (p<0.001). Conclusion In selective cases of few unfavorable clinical findings, CO may also be an effective surgical option for ASDH. Although DC remains to be standard of surgical modality for patients with poor clinical status, CO can be an alternative considering the possible complications of DC. PMID:27182498

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

    PubMed Central

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

    2016-01-01

    Among critically ill patients with lower respiratory tract (LRT)-confirmed influenza, we retrospectively observed worse 28-day clinical outcomes in upper respiratory tract (URT)-negative versus URT-positive subjects. This finding may reflect disease progression and highlights the need for influenza testing of both URT and LRT specimens to improve diagnostic yield and possibly inform prognosis. PMID:26966696

  19. 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

  20. Characterization of Potential Outcome Measures for Future Clinical Trials in Fragile X Syndrome

    ERIC Educational Resources Information Center

    Berry-Kravis, Elizabeth; Sumis, Allison; Kim, Ok-Kyung; Lara, Rebecca; Wuu, Joanne

    2008-01-01

    Clinical trials targeting recently elucidated synaptic defects in fragile X syndrome (FXS) will require outcome measures capable of assessing short-term changes in cognitive functioning. Potentially useful measures for FXS were evaluated here in a test-retest setting in males and females with FXS (N = 46). Good reproducibility, determined by an…

  1. 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…

  2. 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

  3. 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

  4. Clinical Characteristics and Impact of Diabetes Mellitus on Outcomes in Patients with Nonvalvular Atrial Fibrillation

    PubMed Central

    Huang, Bi; Zhu, Jun; Liang, Yan; Zhang, Han; Tian, Li; Shao, Xinghui; Wang, Juan

    2015-01-01

    Purpose Studies have shown that diabetes mellitus (DM) is a risk factor for cardiovascular disease, including atrial fibrillation (AF); however, the clinical characteristics and prognostic impact of DM in patients with nonvalvular AF have not been well understood in China. Materials and Methods Included were 1644 consecutive patients with nonvalvular AF. Endpoints included all-cause mortality, cardiovascular mortality, stroke, major bleeding, and combined endpoint events (CEE) during a 1-year follow-up. Results The prevalence of DM was 16.8% in nonvalvular AF patients. Compared with non-diabetic AF patients, diabetic AF patients were older and tended to coexist with other cardiovascular diseases. Most patients with DM (93.5%) were eligible for anticoagulation, as determined by CHADS2 scores. However, only 11.2% of patients received anticoagulation. During a 1-year follow-up, the all-cause mortality and CEE rate in the DM group were significantly higher than those of the non-DM group, while the incidence of stroke was comparable. After multivariate adjustments, DM was still an independent risk factor for 1-year all-cause mortality [hazard ratio (HR)=1.558; 95% confidence interval (CI) 1.126-2.156; p=0.007], cardiovascular mortality (HR=1.615; 95% CI 1.052-2.479; p=0.028), and CEE (HR=1.523; 95% CI 1.098-2.112; p=0.012), yet not for stroke (HR=1.119; 95% CI 0.724-1.728; p=0.614). Conclusion DM is a common morbidity coexisting with nonvalvular AF and is associated with an increased risk of 1-year all-cause mortality, cardiovascular mortality, and CEE. However, no increased risk of stroke was found during a 1-year follow-up in patients with AF and DM. PMID:25510748

  5. Clinical characteristics and post-surgical outcomes of focal cortical dysplasia subtypes.

    PubMed

    Xue, Hai; Cai, Lixin; Dong, Sheng; Li, Yongjie

    2016-01-01

    We retrospectively studied 105 patients with a focal cortical dysplasia (FCD) diagnosed on pathological examination, and investigated the long term postoperative seizure outcomes, different clinical characteristics of the three FCD subtypes, particularly type I and II, and surgical outcomes for each group. FCD is a common cause of drug-resistant epilepsy, which is divided into three different subtypes according to its involvement at different stages of brain development. Each of these groups may have different characteristics and may even have different surgical outcomes. After treatment, 55% of patients were completely seizure-free, with two significant predictive variables for poorer outcomes: focal MRI findings and electrode implantation. FCD type I had relatively poor surgical outcomes compared to FCD type II and type IIIa. Compared with FCD type I, type II, particularly IIb, had a higher frequency of seizure attacks, predominantly located in the extratemporal lobes, and was more readily detected and diagnosed via focal lesions on MRI and localized electroencephalogram abnormalities. FCD type II patients seem to show better surgical outcomes than FCD type I, but the difference was not significant. Larger cohort studies are needed for further evaluation of the seizure outcomes of different FCD subtypes. PMID:26314661

  6. Early prediction of neurological outcome after falls in children: metabolic and clinical markers.

    PubMed Central

    Paret, G; Tirosh, R; Lotan, D; Stein, M; Ben-Abraham, R; Vardi, A; Harel, R; Barzilay, Z

    1999-01-01

    Falls are the foremost reason for non-fatal injuries and are second only to motor vehicle accidents in causing accidental death. The purpose of this study was to identify the clinical and metabolic predictors of the outcome of head injury caused by falls from a height. Medical records of 61 children who had been admitted to the paediatric intensive care unit from 1990 to 1993 after falling from a height were reviewed retrospectively. Outcomes were categorised as good, moderate, severe, and poor. Glasgow coma scores, pupillary responses, brain oedema, and midline shift are significantly associated with poor outcome (p < 0.05). Metabolic markers associated with poor outcome included hyperglycaemia and hypokalaemia. Children with a poor outcome had, at admission, significantly higher glucose concentrations compared with children with good outcomes (mean SD): 20.0 (7.1) v 9.31 (4.0) mmol/l, p < 0.01), and lower potassium concentrations compared with children with good, moderate, and severe outcomes (mean (SD): 2.8 (0.4) v 3.7 (0.4) mmol/l, p < 0.001, 3.5 (0.3) mmol/l, p < 0.01, and 3.41 (0.3) mmol/l, p < 0.05, respectively). These findings allow for an early allocation of effort and resources to children injured from such falls. Images Figure 1 Figure 2 PMID:10353044

  7. Low Mitochondrial DNA Copy Number is Associated With Adverse Clinical Outcomes in Peritoneal Dialysis Patients.

    PubMed

    Yoon, Chang-Yun; Park, Jung Tak; Kee, Youn Kyung; Han, Seung Gyu; Han, In Mee; Kwon, Young Eun; Park, Kyoung Sook; Lee, Mi Jung; Han, Seung Hyeok; Kang, Shin-Wook; Yoo, Tae-Hyun

    2016-02-01

    Mitochondrial dysfunction may play an important role in abnormal glucose metabolism and systemic inflammation. We aimed to investigate the relationship between mitochondrial DNA (mtDNA) copy number and clinical outcomes in peritoneal dialysis (PD) patients. We recruited 120 prevalent PD patients and determined mtDNA copy number by PCR. Primary outcome was all-cause mortality, whereas secondary outcomes included cardiovascular events, technical PD failure, and incident malignancy. Cox proportional hazards analysis determined the independent association of mtDNA copy number with outcomes. The mean patient age was 52.3 years; 42.5% were men. The mean log mtDNA copy number was 3.30 ± 0.50. During a follow-up period of 35.4 ± 19.3 months, all-cause mortality and secondary outcomes were observed in 20.0% and 59.2% of patients, respectively. Secondary outcomes were significantly lower in the highest mtDNA copy number group than in the lower groups. In multiple Cox analysis, the mtDNA copy number was not associated with all-cause mortality (lower two vs highest tertile: hazard ratio [HR] = 1.208, 95% confidence interval [CI] = 0.477-3.061). However, the highest tertile group was significantly associated with lower incidences of secondary outcomes (lower two vs highest tertile: HR [95% CI] = 0.494 [0.277-0.882]) after adjusting for confounding factors. The decreased mtDNA copy number was significantly associated with adverse clinical outcomes in PD patients. PMID:26886611

  8. Low Mitochondrial DNA Copy Number is Associated With Adverse Clinical Outcomes in Peritoneal Dialysis Patients

    PubMed Central

    Yoon, Chang-Yun; Park, Jung Tak; Kee, Youn Kyung; Han, Seung Gyu; Han, In Mee; Kwon, Young Eun; Park, Kyoung Sook; Lee, Mi Jung; Han, Seung Hyeok; Kang, Shin-Wook; Yoo, Tae-Hyun

    2016-01-01

    Abstract Mitochondrial dysfunction may play an important role in abnormal glucose metabolism and systemic inflammation. We aimed to investigate the relationship between mitochondrial DNA (mtDNA) copy number and clinical outcomes in peritoneal dialysis (PD) patients. We recruited 120 prevalent PD patients and determined mtDNA copy number by PCR. Primary outcome was all-cause mortality, whereas secondary outcomes included cardiovascular events, technical PD failure, and incident malignancy. Cox proportional hazards analysis determined the independent association of mtDNA copy number with outcomes. The mean patient age was 52.3 years; 42.5% were men. The mean log mtDNA copy number was 3.30 ± 0.50. During a follow-up period of 35.4 ± 19.3 months, all-cause mortality and secondary outcomes were observed in 20.0% and 59.2% of patients, respectively. Secondary outcomes were significantly lower in the highest mtDNA copy number group than in the lower groups. In multiple Cox analysis, the mtDNA copy number was not associated with all-cause mortality (lower two vs highest tertile: hazard ratio [HR] = 1.208, 95% confidence interval [CI] = 0.477–3.061). However, the highest tertile group was significantly associated with lower incidences of secondary outcomes (lower two vs highest tertile: HR [95% CI] = 0.494 [0.277–0.882]) after adjusting for confounding factors. The decreased mtDNA copy number was significantly associated with adverse clinical outcomes in PD patients. PMID:26886611

  9. Using evidence-based practice for managing clinical outcomes in advanced practice nursing.

    PubMed

    Glanville, I; Schirm, V; Wineman, N M

    2000-10-01

    Preparation of advanced practice nurses to assume leadership positions for clinical decision making requires that traditional ways of solving clinical problems be augmented with information from relevant, research-derived evidence. In this article, the authors describe how one graduate program prepares advanced practice nurses to use the best scientific evidence with clinical expertise to influence patient outcomes. The assignments that students complete in their program provide examples of evidence-based practice that apply quality improvement principles and science-based nursing interventions to create best practices. PMID:11008434

  10. 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

  11. A Systematic Review and Meta-analysis Comparing Clinical Outcomes After Concurrent Rotator Cuff Repair and Long Head Biceps Tenodesis or Tenotomy

    PubMed Central

    Leroux, Timothy; Chahal, Jaskarndip; Wasserstein, David; Verma, Nikhil N.; Romeo, Anthony A.

    2015-01-01

    Context: A comparison of clinical outcomes after long head of biceps (LHB) tenotomy or tenodesis performed concurrently with rotator cuff repair (RCR) is of interest to physicians and patients. Objective: A systematic review of clinical outcome studies examining LHB tenotomy or tenodesis performed concurrently with RCR. Secondarily, perform a meta-analysis of data from comparative studies. Data Sources: MEDLINE (1946 to week 30 of 2013) and EMBASE (1980 to week 30 of 2013). Study Selection: Levels 1 through 4 studies reporting clinical outcomes of concurrent RCR and LHB tenotomy or tenodesis with minimum 1-year follow-up. Study Design: Systematic review and meta-analysis. Level of Evidence: Level 4. Data Extraction: Two independent reviewers identified eligible studies and applied the exclusion criteria. Clinical outcome data, including functional outcome score(s), biceps deformity and cramping, and patient satisfaction, were extracted. Clinical outcome data from included studies were pooled (weighted according to study size) and reported. A meta-analysis was performed only on outcomes extracted from comparative studies (α = 0.05). Results: Twelve studies (N = 565 patients; mean age, 61.3 years; 46.3% men) were included. Of these, 6 (N = 263) included RCR and LHB tenotomy and 9 (N = 302) included RCR and LHB tenodesis. A meta-analysis was performed on 3 comparative studies (levels 1 and 2), demonstrating that the postoperative Constant score at a mean follow-up of 25.5 months was significantly greater after tenodesis (92.8 [tenodesis] vs 90.6 [tenotomy], P < 0.01); however, this difference was less than the reported minimal clinically important difference of 10.4 points. Similarly, the rate of biceps deformity was significantly less after tenodesis (15.5% [tenotomy] vs 3.9% [tenodesis], P < 0.01); however, most patients were not bothered by it. There were no significant differences in the rate of biceps cramping or patient satisfaction. Conclusion: Although the

  12. Surgical approach in primary total hip arthroplasty: anatomy, technique and clinical outcomes

    PubMed Central

    Petis, Stephen; Howard, James L.; Lanting, Brent L.; Vasarhelyi, Edward M.

    2015-01-01

    Total hip arthroplasty (THA) has revolutionized the treatment of hip arthritis. A number of surgical approaches to the hip joint exist, each with unique advantages and disadvantages. The most commonly used approaches include the direct anterior, direct lateral and posterior approaches. A number of technical intricacies allow safe and efficient femoral and acetabular reconstruction when using each approach. Hip dislocation, abductor insufficiency, fracture and nerve injury are complications of THA, although their relative risk varies by approach. Numerous clinical trials have sought to elicit differences in patient-reported outcomes, complication rates and return to function among the surgical approaches. This review outlines some of the technical pearls of performing a THA through either a direct anterior, direct lateral or posterior approach. A literature review outlines the impact of surgical approach on clinical outcomes and clinically relevant complication rates. PMID:25799249

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

    PubMed

    Hu, Bo; Li, Liang; Greene, Tom

    2016-07-30

    Longitudinal cohort studies often collect both repeated measurements of longitudinal outcomes and times to clinical events whose occurrence precludes further longitudinal measurements. Although joint modeling of the clinical events and the longitudinal data can be used to provide valid statistical inference for target estimands in certain contexts, the application of joint models in medical literature is currently rather restricted because of the complexity of the joint models and the intensive computation involved. We propose a multiple imputation approach to jointly impute missing data of both the longitudinal and clinical event outcomes. With complete imputed datasets, analysts are then able to use simple and transparent statistical methods and standard statistical software to perform various analyses without dealing with the complications of missing data and joint modeling. We show that the proposed multiple imputation approach is flexible and easy to implement in practice. Numerical results are also provided to demonstrate its performance. Copyright © 2015 John Wiley & Sons, Ltd. PMID:26179943

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

    PubMed

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

    2013-08-01

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

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

    PubMed

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

    2016-06-30

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

  16. 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

  17. Clinical Neurochemistry of Subarachnoid Hemorrhage: Toward Predicting Individual Outcomes via Biomarkers of Brain Energy Metabolism.

    PubMed

    Tholance, Yannick; Barcelos, Gleicy; Dailler, Frederic; Perret-Liaudet, Armand; Renaud, Bernard

    2015-12-16

    The functional outcome of patients with subarachnoid hemorrhage is difficult to predict at the individual level. The monitoring of brain energy metabolism has proven to be useful in improving the pathophysiological understanding of subarachnoid hemorrhage. Nonetheless, brain energy monitoring has not yet clearly been included in official guidelines for the management of subarachnoid hemorrhage patients, likely because previous studies compared only biological data between two groups of patients (unfavorable vs favorable outcomes) and did not determine decision thresholds that could be useful in clinical practice. Therefore, this Viewpoint discusses recent findings suggesting that monitoring biomarkers of brain energy metabolism at the level of individuals can be used to predict the outcomes of subarachnoid hemorrhage patients. Indeed, by taking into account specific neurochemical patterns obtained by local or global monitoring of brain energy metabolism, it may become possible to predict routinely, and with sufficient sensitivity and specificity, the individual outcomes of subarachnoid hemorrhage patients. Moreover, combining both local and global monitoring improves the overall performance of individual outcome prediction. Such a combined neurochemical monitoring approach may become, after prospective clinical validation, an important component in the management of subarachnoid hemorrhage patients to adapt individualized therapeutic interventions. PMID:26595414

  18. 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

  19. 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

  20. 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

  1. Impact of Net Atrioventricular Compliance on Clinical Outcome in Mitral Stenosis

    PubMed Central

    Nunes, Maria Carmo P.; Hung, Judy; Barbosa, Marcia M.; Esteves, William A.; Carvalho, Vinicius T.; Lodi-Junqueira, Lucas; Fonseca Neto, Cirilo P.; Tan, Timothy C.; Levine, Robert A.

    2014-01-01

    Background Net atrioventricular compliance (Cn) has been reported to be an important determinant of pulmonary hypertension in mitral stenosis (MS). We hypothesized that, as Cn reflects hemodynamic consequences of MS, it may be useful in assessing prognosis. To date, limited data with an assumed Cn cutoff have indicated the need for larger prospective studies. This prospective study was designed to determine the impact of Cn on clinical outcome and its contribution to pulmonary pressure in MS. In addition, we aimed to identify a cutoff value of Cn for outcome prediction in this setting. Methods and Results A total of 128 patients with rheumatic MS without other significant valve disease were prospectively enrolled. Comprehensive echocardiography was performed and Doppler-derived Cn estimated using a previously validated equation. The endpoint was either mitral valve intervention or death. Cn was an important predictor of pulmonary pressure, regardless of classic measures of MS severity. During a median follow-up of 22 months, the endpoint was reached in 45 patients (35%). Baseline Cn predicted outcome, adding prognostic information beyond that provided by mitral valve area and functional status. Cn ≤ 4 mL/mmHg best predicted unfavorable outcome in derivation and validation sets. A subgroup analysis including only initially asymptomatic patients with moderate to severe MS without initial indication for intervention (40.6 % of total) demonstrated that baseline Cn predicted subsequent adverse outcome even after adjusting for classic measures of hemodynamic MS severity (hazard ratio [HR] 0.33, 95% confidence interval [CI] 0.14–0.79, p = 0.013). Conclusions Cn contributes to pulmonary hypertension beyond of stenosis severity itself. In a wide spectrum of MS severity, Cn is a powerful predictor of adverse outcome, adding prognostic value to clinical data and mitral valve area. Importantly, baseline Cn predicts a progressive course with subsequent need for intervention

  2. Relationship between drug interactions and drug-related negative clinical outcomes

    PubMed Central

    Cremades, Javier; Gonzalo, Mario; Arrebola, Isabel

    2008-01-01

    Drug interactions may represent an iatrogenic risk that should be controlled in community pharmacies at the dispensing level. Aim We analyzed the association between potential drug-drug interactions (DDIs) and negative clinical outcomes. Methods We used dispensing data from two community pharmacies: instances where drug dispensing was associated with a potential DDI and a comparison group of randomized dispensing operations with no potential DDI. In cases where potential DDIs were detected, we analyzed the underlying negative clinical outcomes. Age and gender data were included in the analysis. Results During the study period, we registered 417 potential DDIs. The proportion of women and age were higher in the study group than in the comparison group. The average potential DDIs per patient was 1.31 (SD=0.72). The Consejo General de Colegios Oficiales de Farmacéuticos (CGCOF) database did not produce an alert in 2.4% of the cases. Over-the-counter medication use was observed in 5% of the potential DDI cases. The drugs most frequently involved in potential DDIs were acenocoumarol, calcium salts, hydrochlorothiazide, and alendronic acid, whereas the most predominant potential DDIs were calcium salts and bisphosphonates, oral antidiabetics and thiazide diuretics, antidiabetics and glucose, and oral anticoagulant and paracetamol. The existence of a drug-related negative clinical outcome was observed only in 0.96% of the potential DDI cases (50% safety cases and 50% effectiveness cases). Conclusions Only a small proportion of the detected potential DDIs lead to medication negative outcomes. Considering the drug-related negative clinical outcomes encountered, tighter control would be recommended in potential DDIs with NSAIDs or benzodiazepines. PMID:25147590

  3. Analysis of donor heterogeneity as a factor affecting the clinical outcome of oocyte donation.

    PubMed

    Harris, Sarah E; Faddy, Malcolm; Levett, Stephen; Sharma, Vinay; Gosden, Roger

    2002-11-01

    This study investigated factors that may affect the clinical outcome of oocyte donation on the basis of data from a clinical programme involving 243 treatment cycles analysed retrospectively. In each cohort, oocytes were distributed randomly to one, two or three recipients, which enabled the outcomes in terms of pregnancy and live birth rates to be compared among donors. The results were compared with respect to age of the donor and recipient, number of oocytes collected, fertilization and cleavage rates, qualitative embryo criteria (morphological grade) and other clinical criteria. Most variables had no significant effect on either outcome, although the live birth rate varied inversely with recipient age. Unsurprisingly, the pregnancy rate was correlated positively with the number of embryos transferred. Most of the variation in pregnancy and live birth rates (85-90%) could not be accounted for by any specific donation characteristic, indicating that interdonor heterogeneity was the result of idiopathic factors. The factor most predictive of a recipient's cycle outcome was a history of previous success of the donor, which accounted for approximately 30% of the variation in live birth rates. Pregnancy success rates varied widely among oocyte donors, as has been found among sperm donors. This observation highlights the need to identify markers that predict developmental competence and help to identify the genetic and environmental bases of differential fertility. In conclusion, the quality of oocytes varied widely among women presumed to be fertile by clinical criteria, and the causative factors set a major limitation on the prospects of improving the outcome of egg donation. PMID:12477962

  4. 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

  5. Comparing of Light Transmittance Aggregometry and Modified Thrombelastograph in Predicting Clinical Outcomes in Chinese Patients Undergoing Coronary Stenting with Clopidogrel

    PubMed Central

    Tang, Xiao-Fang; Han, Ya-Ling; Zhang, Jia-Hui; Wang, Jing; Zhang, Yin; Xu, Bo; Gao, Zhan; Qiao, Shu-Bin; Chen, Jue; Wu, Yuan; Chen, Ji-Lin; Gao, Run-Lin; Yang, Yue-Jin; Yuan, Jin-Qing

    2015-01-01

    Background: Several platelet function tests are currently used to measure responsiveness to antiplatelet therapy. This study was to compare two tests, light transmittance aggregometry (LTA) and modified thrombelastography (mTEG), for predicting clinical outcomes in Chinese patients after percutaneous coronary intervention (PCI). Methods: Prospective, observational, single-center study of 789 Chinese patients undergoing PCI was enrolled. This study was investigated the correlations between the two tests and performed receiver operating characteristic curve (ROC) analysis for major adverse cardiovascular events (MACEs) at 1-year follow-up. Results: MACEs occurred in 32 patients (4.1%). Correlations were well between the two tests in the adenosine diphosphate induced platelet reactivity (Spearman r = 0.733, P < 0.001). ROC-curve analysis demonstrated that LTA (area under the curve [AUC]: 0.677; 95% confidence interval [CI]: 0.643–0.710; P = 0.0009), and mTEG (AUC: 0.684; 95% CI: 0.650–0.716; P = 0.0001) had moderate ability to discriminate between patients with and without MACE. MACE occurred more frequently in patients with high on-treatment platelet reactivity (HPR) when assessed by LTA (7.4% vs. 2.7%; P < 0.001), and by TEG (6.7% vs. 2.6%; P < 0.001). Kaplan–Meier analysis demonstrated that HPR based on the LTA and mTEG was associated with almost 3-fold increased risk of MACE at 1-year follow-up. Conclusions: The correlation between LTA and mTEG is relatively high in Chinese patients. HPR measured by LTA and mTEG were significantly associated with MACE in Chinese patients undergoing PCI. PMID:25758271

  6. 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

  7. Clinical evaluation and outcomes of naturally acquired West Nile virus infection in raptors.

    PubMed

    Nemeth, Nicole M; Kratz, Gail E; Bates, Rebecca; Scherpelz, Judy A; Bowen, Richard A; Komar, Nicholas

    2009-03-01

    West Nile virus (WNV) infection and associated disease and mortality have been documented in numerous North American raptor species. Information regarding clinical presentations and long-term outcomes of WNV-infected raptors is important in the clinic for the diagnosis, treatment, and assessment of prognosis, as well as for understanding potential population level effects on raptor species. Raptors of 22 species admitted to a rehabilitation clinic were tested, from 2002 to 2005, for previous and acute WNV infection, while comparing clinical syndromes, trauma, and rehabilitation outcomes. Forty-two percent of admitted raptors (132/314) had been infected with WNV, and these presented with a WNV-attributed clinical disease rate of 67.4% (89/132). West Nile virus-infected raptors were less likely to be released (79/132 [59.8%]) than negative raptors (138/182 [75.8%]) and more likely to die or be euthanized (47/132 [35.6%] for WNV-infected vs. 32/182 [17.6%] for WNV-negative). However, WNV-infected raptors with neurologic disease were no less likely to be released (29/53 [54.7%]) than those without neurologic disease (50/79 [63.3%]). Clinical WNV-associated syndromes varied among species. Great horned owls (Bubo virginianus) were more likely to have neurologic signs, whereas American kestrels (Falco sparverius) and Swainson's hawks (Buteo swainsonii) were less likely to have neurologic signs. These results suggest that free-ranging raptors are frequently infected with WNV and that clinical syndromes differ among species. WNV has potentially devastating effects on raptors; however, rehabilitation of WNV-infected raptors can lead to positive outcomes, even for those having had severe neurologic disease. PMID:19368240

  8. 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

  9. 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

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

    PubMed Central

    Aravindan, Sheeja; Natarajan, Mohan; Azadi, Seifollah; Herman, Terence S.; Aravindan, Natarajan

    2015-01-01

    Clinical outcomes for high-risk neuroblastoma patients remains poor, with only 40–50% 5-Year overall survival (OS) and <10% long-term survival. The ongoing acquisition of genetic/molecular rearrangements in undifferentiated neural crest cells may endorse neuroblastoma progression. This study recognized the loss of Retinal Degeneration protein 3, RD3 in aggressive neuroblastoma, and identified its influence in better clinical outcomes and defined its novel metastasis suppressor function. The results showed ubiquitous expression of RD3 in healthy tissues, complete-loss and significant TNM-stage association of RD3 in clinical samples. RD3-loss was intrinsically associated with reduced OS, abridged relapse-free survival, aggressive stage etc., in neuroblastoma patient cohorts. RD3 was transcriptionally and translationally regulated in metastatic site-derived aggressive (MSDAC) cells (regardless of CSC status) ex vivo and in tumor manifolds from metastatic sites in reproducible aggressive disease models in vivo. Re-expressing RD3 in MSDACs reverted their metastatic potential both in vitro and in vivo. Conversely muting RD3 in neuroblastoma cells not only heightened invasion/migration but also dictated aggressive disease with metastasis. These results demonstrate the loss of RD3 in high-risk neuroblastoma, its novel, thus-far unrecognized metastasis suppressor function and further imply that RD3-loss may directly relate to tumor aggressiveness and poor clinical outcomes. PMID:26375249

  11. 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…

  12. 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

  13. 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…

  14. Naturalistic Outcomes of Evidence-Based Therapies for Borderline Personality Disorder at a Medical University Clinic.

    PubMed

    Gregory, Robert J; Sachdeva, Shilpa

    2016-01-01

    Dialectical behavior therapy (DBT) and dynamic deconstructive psychotherapy (DDP) are listed in the National Registry of Evidence-Based Programs and Practices based on their performances in randomized controlled trials. However, little is known about their effectiveness in real-world settings. In the present study, the authors observed the naturalistic outcomes of 68 clients with borderline personality disorder (BPD) who were treated at a medical university clinic by experienced therapists using either comprehensive DBT (n = 25) or DDP (n = 27), with 16 clients treated with unstructured psychotherapy serving as a control. We found both DBT and DDP achieved significant reductions in symptoms of BPD, depression, and disability by 12 months of treatment, and showed effect sizes consistent with controlled trials. However, attrition from DBT was high and DDP obtained better outcomes than DBT (d = .53). Larger effectiveness studies are needed to replicate these findings, delineate common and unique treatment processes, and determine therapist and patient characteristics predicting positive outcomes. PMID:27329405

  15. Hair mercury concentrations and in vitro fertilization (IVF) outcomes among women from a fertility clinic.

    PubMed

    Wright, Diane L; Afeiche, Myriam C; Ehrlich, Shelley; Smith, Kristen; Williams, Paige L; Chavarro, Jorge E; Batsis, Maria; Toth, Thomas L; Hauser, Russ

    2015-01-01

    Total hair mercury (Hg) was measured among 205 women undergoing in vitro fertilization (IVF) treatment and the association with prospectively collected IVF outcomes (229 IVF cycles) was evaluated. Hair Hg levels (median=0.62ppm, range: 0.03-5.66ppm) correlated with fish intake (r=0.59), and exceeded the recommended EPA reference of 1ppm in 33% of women. Generalized linear mixed models with random intercepts accounting for within-woman correlations across treatment cycles were used to evaluate the association of hair Hg with IVF outcomes adjusted for age, body mass index, race, smoking status, infertility diagnosis, and protocol type. Hair Hg levels were not related to ovarian stimulation outcomes (peak estradiol levels, total and mature oocyte yields) or to fertilization rate, embryo quality, clinical pregnancy rate or live birth rate. PMID:25601638

  16. 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

  17. Cardiovascular disease in chronic kidney disease. A clinical update from Kidney Disease: Improving Global Outcomes (KDIGO).

    PubMed

    Herzog, Charles A; Asinger, Richard W; Berger, Alan K; Charytan, David M; Díez, Javier; Hart, Robert G; Eckardt, Kai-Uwe; Kasiske, Bertram L; McCullough, Peter A; Passman, Rod S; DeLoach, Stephanie S; Pun, Patrick H; Ritz, Eberhard

    2011-09-01

    Cardiovascular morbidity and mortality in patients with chronic kidney disease (CKD) is high, and the presence of CKD worsens outcomes of cardiovascular disease (CVD). CKD is associated with specific risk factors. Emerging evidence indicates that the pathology and manifestation of CVD differ in the presence of CKD. During a clinical update conference convened by the Kidney Disease: Improving Global Outcomes (KDIGO), an international group of experts defined the current state of knowledge and the implications for patient care in important topic areas, including coronary artery disease and myocardial infarction, congestive heart failure, cerebrovascular disease, atrial fibrillation, peripheral arterial disease, and sudden cardiac death. Although optimal strategies for prevention, diagnosis, and management of these complications likely should be modified in the presence of CKD, the evidence base for decision making is limited. Trials targeting CVD in patients with CKD have a large potential to improve outcomes. PMID:21750584

  18. Common Minor Histocompatibility Antigen Discovery Based upon Patient Clinical Outcomes and Genomic Data

    PubMed Central

    Armistead, Paul M.; Liang, Shoudan; Li, Hua; Lu, Sijie; Van Bergen, Cornelis A. M.; Alatrash, Gheath; St. John, Lisa; Hunsucker, Sally A.; Sarantopoulos, Stefanie; Falkenburg, J. H. Frederik; Molldrem, Jeffrey J.

    2011-01-01

    Background Minor histocompatibility antigens (mHA) mediate much of the graft vs. leukemia (GvL) effect and graft vs. host disease (GvHD) in patients who undergo allogeneic stem cell transplantation (SCT) [1], [2], [3], [4]. Therapeutic decision making and treatments [5] based upon mHAs will require the evaluation of multiple candidate mHAs and the selection of those with the potential to have the greatest impact on clinical outcomes. We hypothesized that common, immunodominant mHAs, which are presented by HLA-A, B, and C molecules, can mediate clinically significant GvL and/or GvHD, and that these mHAs can be identified through association of genomic data with clinical outcomes. Methodology/Principal Findings Because most mHAs result from donor/recipient cSNP disparities, we genotyped 57 myeloid leukemia patients and their donors at 13,917 cSNPs [6]. We correlated the frequency of genetically predicted mHA disparities with clinical evidence of an immune response and then computationally screened all peptides mapping to the highly associated cSNPs for their ability to bind to HLA molecules. As proof-of-concept, we analyzed one predicted antigen, T4A, whose mHA mismatch trended towards improved overall and disease free survival in our cohort. T4A mHA mismatches occurred at the maximum theoretical frequency for any given SCT. T4A-specific CD8+ T lymphocytes (CTLs) were detected in 3 of 4 evaluable post-transplant patients predicted to have a T4A mismatch. Conclusions/Significance Our method is the first to combine clinical outcomes data with genomics and bioinformatics methods to predict and confirm a mHA. Refinement of this method should enable the discovery of clinically relevant mHAs in the majority of transplant patients and possibly lead to novel immunotherapeutics [5]. PMID:21858034

  19. 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

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

    PubMed

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

    2014-09-01

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

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

    PubMed

    Bond, Bryan M; Kinslow, Christopher

    2015-06-01

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

  2. 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

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

    PubMed

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

    2007-06-01

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

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

    PubMed

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

    2016-07-01

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

  5. Liver transplantation at the Ochsner Clinic: programmatic expansion and outcomes improvement.

    PubMed

    Carmody, Ian C; Reichman, Trevor W; Bohorquez, Humberto; Cohen, Ari J; Bruce, David S; Therapondos, George; Girgrah, Nigel; Joshi, Shobha; Loss, George E

    2012-01-01

    Liver transplantation has become the best and most durable treatment for both acute and chronic liver disease. Over 1400 liver transplants have been performed at the Ochsner Clinic since the first successful transplant in 1987. Since its inception, the program has gone through several changes and advancements and has become one of the largest liver transplant programs in the United States. We have helped evolve steroid sparing immunosuppression and the use of extended criteria, donor organs. Establishment of criteria for the selection of recipients for re-transplantation has resulted in better than expected short and long-term results. Our center has faced the challenge of Hurricane Katrina and overcome it. We have improved steadily in both outcomes and transplants performed. The Ochnser Clinic Liver Transplant program will continue to improve access and outcomes for all patients with liver disease. PMID:23721014

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

    PubMed

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

    2016-07-01

    Idiopathic normal pressure hydrocephalus (INPH) is a syndrome of gait disturbance, dementia and urinary incontinence. Outcomes after ventriculoperitoneal shunting for INPH are variable due to a lack of reliable, quantitative outcome data and inconsistent methods of selecting shunt candidates. The aim of this retrospective cohort study was to assess objective and quantitative clinical outcomes of ventriculoperitoneal shunting for INPH. From 2008 to 2013, consecutive patients diagnosed with INPH based on clinical and radiological criteria were included in this single-centre study. All patients received programmable-valve ventriculoperitoneal shunts. Outcome measures were assessed at baseline, 3, 6 and 12months post-operatively. Outcomes included gait time and scores on the Unified Parkinson's Disease Rating Scale part III (UPDRS-III), the Addenbrooke's Cognitive Examination Revised (ACE-R) and the Mini-Mental State Examination (MMSE). Thresholds for improvements were set a priori as ⩾20% decrease in gait time, ⩾10point decrease in UPDRS-III score, ⩾5point increase in ACE-R score and ⩾2point increase in MMSE score at last follow-up. The proportion of patients improving varied between measures, being gait time (60%), UPDRS-III (69%), MMSE (63%), and ACE-R (56%). Overall, improvement in at least one outcome measure was observed in 85% of patients and 38% improved in gait time, UPDRS-III score and cognitive scores. Only 15% of patients experienced no improvement on any measure. This study demonstrates that the majority of INPH patients can sustain improvements in multiple symptoms up to 12months after shunting. PMID:26935749

  7. Biological, physical factors in clinical assessment of outcome of cancer therapy.

    PubMed

    Perez, Carlos A

    2005-01-01

    Complex molecular and cellular biological phenomena influence the response of tumor and normal cell to cytotoxic agents, including irradiation. Innovative 3-D treatment planning and IGRT techniques allow more quantitative optmization of irradiation dose distribution in target volumes and OAR. More detailed reporting on radiation doses is required with incorporation of biological parameters in treatment planning and dose specification. TCP and NTCP models should be validate with actual clinical data. Quality assurance in radiation oncology is mandatory. Because of increasing concerns with health care costs, technology assessment and cost benefit studies should be an integral component of clinical outcome reporting. PMID:16294900

  8. Clinical, Biochemical and Outcome Profile of Biotinidase Deficient Patients from Tertiary Centre in Northern India

    PubMed Central

    Singh, Ankur; Lomash, Avinash; Pandey, Sanjeev

    2015-01-01

    Introduction Biotinidase deficiency is an inherited metabolic disorder with estimated birth incidence of 1 in 61,000 for profound and partial deficiency. Estimated incidence of profound and partial biotinidase deficiency is 1 in 1, 37,000 and 1 in 1, 10,000 respectively. The carrier frequency in general population is 1 in 120. We attempt to study clinical, biochemical and outcome from 10 Biotinidase deficient patients. Materials and Methods A retrospective case record study was conducted to record Clinical, biochemical and outcome profile from genetic records. Biotinidase level was measured using spectrophotometric method. Results Study group comprised of 8 males and 2 females with median age of presentation 6 (2-45.75) months. Median (interquartile range) Biotinidase level in study group 0.3 (0.08—1.5) nmol/ml/min. Study group was further divided in to early onset group (< 12 months, n-6) and late onset group (> 12 months, n-4). Seizure, alopecia and hearing loss were predominant phenotypes in study group. The other rare presentations were: hypotonia, ataxia, skin rash, seborrhoea. The most common seizure type was focal seizure. Control of seizure activity was important immediate outcome measured in study group. Median duration (interquartile range) of seizure control in early onset group was 3 (2-4)days against 13.5 (12.25-14.75) days in late onset group. Conclusion This study highlights the need of early diagnosis for favourable outcome for a potentially treatable inherited metabolic disorder. PMID:26816961

  9. 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

  10. 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

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

    PubMed

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

    2014-03-01

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

  12. The Association of Diabetes Mellitus with Clinical Outcomes after Coronary Stenting: A Meta-Analysis

    PubMed Central

    Jiang, Hai-Xing; Hu, Bang-Li; Tao, Lin; Xie, Min-zhi

    2013-01-01

    Background Previous studies have shown inconsistent results on the association between diabetes mellitus (DM) and some clinical outcomes. We conducted a meta-analysis of observational studies to assess effect of DM on clinical outcomes after coronary stenting. Methods We searched for studies without language restriction in PubMed, Embase and Cochrane library prior to 2012. The clinical outcomes including in-stent restenosis (ISR), major adverse cardiac events (MACE), stent thrombosis (ST), target lesion revascularization (TLR) and target vessel revascularization (TVR). Adjusted odds ratio (OR), and the corresponding 95% confidence interval (95% CI) was summarized. Results 55 studies involving 128,084 total patients (38,416 DM patients and 89,668 controls) were eligible for our analysis. Overall, there were significant associations between DM and ISR (OR = 1.70, 95% CI: 1.53–1.89, I2 = 0.0%), MACE (OR = 1.54, 95% CI: 1.36–1.73, I2 = 29.0%), ST (OR = 2.01, 95% CI: 1.36–2.97, I2 = 47.7%), TLR (OR = 1.46, 95% CI: 1.26–1.68, I2 = 43.3%) as well as TVR (OR = 1.33, 95% CI: 1.17–1.51, I2 = 48.3). Subgroup analysis showed that the associations were similar between BMS and DES implantation. Moreover, there was no significant association in the ST subgroup after 1–3 years follow-up. Conclusions Our meta-analysis suggests that after coronary stent implantation, DM is associated with ISR, MACE, ST, TLR and TVR. DM appears to be a vital risk factor of these clinical outcomes. PMID:24066025

  13. Cryptococcemia. An analysis of 28 cases with emphasis on the clinical outcome and its etiologic agent.

    PubMed

    Pasqualotto, Alessandro Comarú; Bittencourt Severo, Cecília; de Mattos Oliveira, Flávio; Severo, Luiz Carlos

    2004-09-01

    Clinical protocols of 28 cases of cryptococcemia studied between April 1995 and November 2002 were reviewed. The varieties of Cryptococcus neorformans, the underlying disease, and the severity and outcome of the disease were emphasized. Most patients were immunossupressed (89.3% with AIDS) and Cryptococcus neoformans var. grubii was the main recovered variety (92.8%). Regardless of antifungal treatment, in-hospital mortality was 41% strongly associated with APACHE II score, >14 (p<0.01). PMID:15709789

  14. 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

  15. Clinical Characteristics and Outcome in Dogs with Splenic Marginal Zone Lymphoma

    PubMed Central

    O’Brien, D.; Moore, P.F.; Vernau, W.; Peauroi, J.R.; Rebhun, R.B.; Rodriguez, C.O.; Skorupski, K.A.

    2016-01-01

    Background Splenic marginal zone lymphoma (MZL) is a form of indolent B-cell lymphoma that is not well characterized in dogs. Hypothesis/Objectives The purpose of this study was to describe clinical characteristics and outcome in dogs with splenic MZL confirmed by histopathology, immunophenotyping, and molecular clonality assessment. We hypothesized that affected dogs would have prolonged survival time with splenectomy alone. Animals Thirty-four dogs were included. Twenty-nine dogs were diagnosed after splenectomy, and 5 dogs were diagnosed at necropsy. Methods Pathology records were searched for dogs with histologically confirmed splenic MZL. Clinical and outcome data were retrospectively collected by medical record review, and prognostic factors were evaluated. Histopathology was reviewed by a board-certified pathologist, and tissue sections were subjected to immunophenotyping and molecular clonality assessment by PCR. Results Immunohistochemistry confirmed a B-cell phenotype for all dogs. Molecular clonality assessment was performed in 33 of 34 dogs, of which 24 had clonal rearrangement of immunoglobulin (Ig) loci, 3 had pseudoclonal rearrangement, and 6 had polyclonal rearrangement. The overall median survival time (MST) for the 29 dogs that underwent splenectomy was 383 days. The MST for 14 of 29 asymptomatic dogs that underwent splenectomy for MZL was 1,153 days as compared to 309 days for 15/29 dogs with clinical signs referable to splenic MZL (P = .018). Lymph node involvement, hemoabdomen, anemia, chemotherapy, and concurrent malignancy did not affect survival outcome. Conclusions and Clinical Importance Dogs diagnosed with splenic MZL can have prolonged survival with splenectomy alone, without the use of adjuvant chemotherapy. Asymptomatic dogs may have a better survival outcome. PMID:23734665

  16. 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

  17. Toric intraocular lenses: historical overview, patient selection, IOL calculation, surgical techniques, clinical outcomes, and complications.

    PubMed

    Visser, Nienke; Bauer, Noël J C; Nuijts, Rudy M M A

    2013-04-01

    We present an overview of currently available toric intraocular lenses (IOLs) and multifocal toric IOLs. Relevant patient selection criteria, IOL calculation issues, and surgical techniques for IOL implantation are discussed. Clinical outcomes including uncorrected visual acuity, residual refractive astigmatism, and spectacle independency, which have been reported for both toric IOLs and multifocal toric IOLs, are reviewed. The incidence of misalignment, the most important complication of toric IOLs, is determined. Finally, future developments in the field of toric IOLs are discussed. PMID:23522584

  18. 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

  19. 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

  20. 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

  1. The EMPA-REG outcome study: critical appraisal and potential clinical implications.

    PubMed

    Perseghin, Gianluca; Solini, Anna

    2016-01-01

    Diabetes health care professionals have to face a study with results of incomparable success in secondary and tertiary cardiovascular disease prevention. In the past, no studies in patients with type 2 diabetes resulted to be successful in inducing an improvement of cardiovascular prognosis, no matter whether they were focused on a target, on life-style or on pharmacological intervention. On a clinical perspective, should the diabetologist's way to think about the anti-diabetic therapy of patients on secondary cardiovascular prevention change based on the results of Empa-Reg outcome? Due to the complexity of the clinical picture of patients with type 2 diabetes, a tailored therapy based on targets, complications, co-morbidity, familial and social environment, personal and cultural features must be conceived and applied in starting pharmacological therapy; however, the question whether should we consider empagliflozin as first choice therapy in individuals with type 2 diabetes exposed to high cardiovascular risk, the Empa-Reg outcome-like patient, awaits now for an answer. Waiting for data confirming the results of the Empa-Reg outcome study, this report goes through the good reasons in support of this way of thinking, but at the same time explores the many unanswered questions raising potential concerns about this clinical choice. PMID:27260022

  2. Clinical outcomes of splenectomy in children: report of the splenectomy in congenital hemolytic anemia registry.

    PubMed

    Rice, Henry E; Englum, Brian R; Rothman, Jennifer; Leonard, Sarah; Reiter, Audra; Thornburg, Courtney; Brindle, Mary; Wright, Nicola; Heeney, Matthew M; Smithers, Charles; Brown, Rebeccah L; Kalfa, Theodosia; Langer, Jacob C; Cada, Michaela; Oldham, Keith T; Scott, J Paul; St Peter, Shawn; Sharma, Mukta; Davidoff, Andrew M; Nottage, Kerri; Bernabe, Kathryn; Wilson, David B; Dutta, Sanjeev; Glader, Bertil; Crary, Shelley E; Dassinger, Melvin S; Dunbar, Levette; Islam, Saleem; Kumar, Manjusha; Rescorla, Fred; Bruch, Steve; Campbell, Andrew; Austin, Mary; Sidonio, Robert; Blakely, Martin L

    2015-03-01

    The outcomes of children with congenital hemolytic anemia (CHA) undergoing total splenectomy (TS) or partial splenectomy (PS) remain unclear. In this study, we collected data from 100 children with CHA who underwent TS or PS from 2005 to 2013 at 16 sites in the Splenectomy in Congenital Hemolytic Anemia (SICHA) consortium using a patient registry. We analyzed demographics and baseline clinical status, operative details, and outcomes at 4, 24, and 52 weeks after surgery. Results were summarized as hematologic outcomes, short-term adverse events (AEs) (≤30 days after surgery), and long-term AEs (31-365 days after surgery). For children with hereditary spherocytosis, after surgery there was an increase in hemoglobin (baseline 10.1 ± 1.8 g/dl, 52 week 12.8 ± 1.6 g/dl; mean ± SD), decrease in reticulocyte and bilirubin as well as control of symptoms. Children with sickle cell disease had control of clinical symptoms after surgery, but had no change in hematologic parameters. There was an 11% rate of short-term AEs and 11% rate of long-term AEs. As we accumulate more subjects and longer follow-up, use of a patient registry should enhance our capacity for clinical trials and engage all stakeholders in the decision-making process. PMID:25382665

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

    PubMed

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

    1995-01-01

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

  4. 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

  5. Comparison of clinical outcomes between ABO-compatible and ABO-incompatible spousal donor kidney transplantation

    PubMed Central

    Park, Woo Yeong; Kang, Seong Sik; Park, Sung Bae; Park, Ui Jun; Kim, Hyong Tae; Cho, Won Hyun; Han, Seungyeup

    2016-01-01

    Background Kidney transplantation (KT) is the treatment of choice for end-stage renal disease patients. The spouse is a major donor in living KT. Clinical outcomes of spousal donor KT are not inferior to those of living related donor KT. In this study, we compared clinical outcomes between ABO-compatible (ABOc) and ABO-incompatible (ABOi) spousal donor KTs. Methods Thirty-two cases of spousal donor KT performed from January 2011 to August 2013 were analyzed retrospectively. Twenty-one ABOc KTs and 11 ABOi KTs were performed. We investigated patient survival, graft survival, acute rejection, graft function, and complications. Results During follow-up, patient and graft survival rates were 100% in both groups. There were no significant differences in the incidence of delayed graft function, acute rejection, and the change in graft function between the 2 groups. Medical and surgical complications were not significantly different between the groups. Conclusion The clinical outcomes of ABOc and ABOi spousal donor KTs were equivalent. In ABOi KT, an emotionally motivated spousal donor KT may be a good alternative to the problem of the absolute shortage of kidney donations. PMID:27069858

  6. Correlation of AOL Recanalization, TIMI Reperfusion and TICI Reperfusion with Infarct Growth and Clinical Outcome

    PubMed Central

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

    2014-01-01

    Objective To understand how three commonly utilized measures of endovascular therapy correlate with clinical outcome and infarct growth. Methods Prospectively enrolled patients underwent baseline MRI and started endovascular therapy within 12 hours of stroke onset. The final angio was given a recanalization score of the primary arterial occlusive lesion- AOL (0-3), a Thrombolysis in Myocardial Infarct (TIMI) Score (0-3) and a Thrombolysis in Cerebral Infarction (TICI) Score (0-3). Scores were dichotomized into poor revascularization (AOL 0-2, TIMI 0-1 and TICI 0-2a) versus good (AOL 3, TIMI 2-3, TICI 2b-3). Patients were classified as Target Mismatch (TMM) or no TMM. Good outcome was a 90 day mRS of 0-2. Results 100 patients had attempted endovascular treatment. TICI 2B-3 patients had 57% good outcome compared to 24% of TICI 0-2A patients (p=0.001). TIMI 2-3 patients and AOL 3 patients had lower rates of good outcome (44% and 47% respectively) which were not significantly better than TIMI 0-1 or AOL 0-2. In the TMM patients these rates of good outcome improved with all scoring systems and were significantly better for TIMI and TICI scores. TICI 2A patients had rates of GFO and lesion growth which were not different then TICI 0-1 patients but significantly worse than TICI 2B-3 patients. Conclusion TIMI 2-3 and TICI 2B-3 reperfusion scores demonstrated improved outcome in mismatch patients with small infarct core and a larger hypoperfused region. AOL scores did not. TICI 2A patients had poorer outcome and more lesion growth than TICI 2B-3 patients. PMID:24353330

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

    PubMed Central

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

    2016-01-01

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

  9. Depressive Symptoms, Anatomical Region, and Clinical Outcomes for Patients Seeking Outpatient Physical Therapy for Musculoskeletal Pain

    PubMed Central

    Coronado, Rogelio A.; Beneciuk, Jason M.; Valencia, Carolina; Werneke, Mark W.; Hart, Dennis L.

    2011-01-01

    Background Clinical guidelines advocate the routine identification of depressive symptoms for patients with pain in the lumbar or cervical spine, but not for other anatomical regions. Objective The purpose of this study was to investigate the prevalence and impact of depressive symptoms for patients with musculoskeletal pain across different anatomical regions. Design This was a prospective, associational study. Methods Demographic, clinical, depressive symptom (Symptom Checklist 90–Revised), and outcome data were collected by self-report from a convenience sample of 8,304 patients. Frequency of severe depressive symptoms was assessed by chi-square analysis for demographic and clinical variables. An analysis of variance examined the influence of depressive symptoms and anatomical region on intake pain intensity and functional status. Separate hierarchical multiple regression models by anatomical region examined the influence of depressive symptoms on clinical outcomes. Results Prevalence of severe depression was higher in women, in industrial and pain clinics, and in patients who reported chronic pain or prior surgery. Lower prevalence rates were found in patients older than 65 years and those who had upper- or lower-extremity pain. Depressive symptoms had a moderate to large effect on pain ratings (Cohen d=0.55–0.87) and a small to large effect on functional status (Cohen d=0.28–0.95). In multivariate analysis, depressive symptoms contributed additional variance to pain intensity and functional status for all anatomical locations, except for discharge values for the cervical region. Conclusions Rates of depressive symptoms varied slightly based on anatomical region of musculoskeletal pain. Depressive symptoms had a consistent detrimental influence on outcomes, except on discharge scores for the cervical anatomical region. Expanding screening recommendations for depressive symptoms to include more anatomical regions may be indicated in physical therapy

  10. Clinical characteristics and outcome of Penicillium marneffei infection among HIV-infected patients in northern Vietnam

    PubMed Central

    2012-01-01

    Objective This study reports the clinical characteristics and outcome of HIV-associated Penicilliummarneffei infection in northern Vietnam. Methods We conducted a retrospective chart review of all patients with laboratory confirmed Penicilliummarneffei infection admitted to the National Hospital for Tropical Diseases in Hanoi, Vietnam, between July 2006 and September 2009. Results 127 patients with P. marneffei infection were identified. All were HIV-infected; median CD4+ T-cell count was 24 cells/μl (IQR:12-48); 76% were men. Common clinical features were fever (92.9%), skin lesions (82.6%), hepatomegaly (61.4%), lymphadenopathy (40.2%), weight loss (59.1%) and cough (49.6%). Concurrent opportunistic infections were present in 22.0%; half of those had tuberculosis. Initial treatment regimens were: itraconazole or ketoconazole capsule (77.2%), amphotericin B (20.5%), and fluconazole (1.6%). In-hospital mortality was 12.6% and showed no significant difference in patients treated with itraconazole (or ketoconazole) and amphotericin B (p = 0.43). Dyspnea, ascites, and increased LDH level were independent predictors of mortality. No seasonality was observed. Conclusion The clinical features, treatments and outcomes of HIV-associated P. marneffei infection in northern Vietnam are similar to those reported in other endemic regions. Dyspnea was an important predictor of mortality. More patients were treated with itraconazole than amphotericin B and no significant difference in treatment outcome was observed. It would be of clinical value to compare the efficacy of oral itraconazole and amphotericin B in a clinical trial. PMID:22897817

  11. Treatment, Outcomes, and Clinical Trial Participation in Elderly Patients With Metastatic Pancreas Adenocarcinoma

    PubMed Central

    Li, Daneng; Capanu, Marinela; Yu, Kenneth H.; Lowery, Maeve A.; Kelsen, David P.; O’Reilly, Eileen M.

    2016-01-01

    Studies on the treatment patterns and outcomes of elderly patients with metastatic pancreas cancer remain limited. Therefore, an analysis of systemic therapy use, clinical trial participation, and outcomes in elderly patients with metastatic pancreas cancer was performed at our institution. Elderly patients who received systemic therapy had a longer survival compared with those who did not. However, therapeutic clinical trial participation was low and should be encouraged Background Pancreas adenocarcinoma has a median age at diagnosis of 71 years. Limited studies have focused on the treatment of elderly patients with pancreas cancer. Patients and Methods An analysis of systemic therapy use, clinical trial participation, and overall outcomes of 237 patients with metastatic pancreas adenocarcinoma ≥ 75 years of age evaluated at Memorial Sloan-Kettering Cancer Center between 2005 and 2013 was undertaken. Results Median overall survival was 7 months for the entire study population. A total of 197 (83%) patients received systemic therapy, which was significantly associated with longer overall survival (P < .01). No significant difference was detected in survival between age groups 75 to 79, 80 to 84, and ≥ 85 years of age among those who received systemic therapy (P = .49). Seventy-seven (32%) patients participated in a clinical trial of whom 13 (5%) patients were enrolled in a therapeutic trial, including no patients aged ≥ 85 years. Multivariate analysis demonstrated that presence of liver metastases (P < .001), performance status (P < .001), and number of systemic agents (P < .001) were significantly associated with survival. Conclusion Receipt of systemic therapy was associated with longer survival in elderly patients ≥ 75 years of age with metastatic pancreas adenocarcinoma. Therapeutic clinical trial participation among these patients was low and future development of prognostic models for appropriate patient selection is warranted. PMID:26072442

  12. Association of sunlight exposure and photoprotection measures with clinical outcome in systemic lupus erythematosus.

    PubMed

    Vilá, L M; Mayor, A M; Valentín, A H; Rodríguez, S I; Reyes, M L; Acosta, E; Vilá, S

    1999-06-01

    This study was designed to explore the relationship of sunlight exposure and ultraviolet (UV) light protection measures with clinical outcome in systemic lupus erythematosus (SLE). A structured questionnaire was administered to sixty Puerto Rican SLE patients, to assess their attitudes and behavior regarding sunlight exposure and photoprotection measures. Medical records were reviewed to evaluate the clinical outcome measures that included: clinical manifestations, number of SLE-related hospitalizations, number of exacerbations and pharmacologic treatment. Almost all (98.3%) patients were well acquainted of sunlight effects on disease activity. Two thirds were exposed to direct sunlight for an average of less than one hour per day and 33.3% for one hour or more. Thirty patients (50%) reported use of sunscreen, with sun protective factor of 15 or greater, when exposed to sunlight. Less than 40% of patients regularly wore hat or long-sleeves clothes to protect from sunlight. Although there were some clinical differences between the groups with different sunlight exposure times, none reached statistical significance. Also, no significant differences were found between the groups in regards to sunlight protective clothes. However, patients that regularly used sunscreen had significantly lower renal involvement (13.3 vs 43.3%), thrombocytopenia (13.3 vs 40%), hospitalizations (26.7 vs. 76.7%), and requirement of cyclophosphamide treatment (6.7 vs. 30%) than patients that did not used it (P < 0.05). We conclude that use of sunscreen photoprotection was associated with a better clinical outcome in our SLE patients. These findings further support the importance and benefits of photoprotective measures in patients with SLE. PMID:10461313

  13. Thrombolytic-Related Asymptomatic Hemorrhagic Transformation Does Not Deteriorate Clinical Outcome: Data from TIMS in China

    PubMed Central

    Jia, Weihua; Liao, Xiaoling; Pan, Yuesong; Wang, Yilong; Cui, Tao; Zhou, Lichun; Wang, Yongjun

    2015-01-01

    Objective It has been unclear whether thrombolytic-related asymptomatic hemorrhagic transformation (AHT) affects the clinical outcome. To answer this question, we examined whether thrombolytic-related AHT affect short-term and long-term clinical outcome. Methods All data were collected from the Thrombolysis Implementation and Monitor of Acute Ischemic Stroke in China (TIMS-China) registry. The patients were diagnosed as having AHT group and non- hemorrhagic transformation (HT) group based on clinical and imaging data. The patients with symptomatic hemorrhagic transformation were excluded from this study. Thrombolytic-related AHT was defined according to European-Australasian Acute Stroke Study (ECASS) II criteria. 90-day functional outcome, 7-day National Institutes of Health Stroke Scale (NIHSS) score, 7-day and 90-day mortalities were compared between two groups. Logistic regression analysis was used to evaluate the effects of AHT on a short-term and long-term clinical outcome. Results 904 of all 1440 patients in TIMS-China registry were enrolled. 89 (9.6%) patients presented with AHT after thrombolysis within 24-36h. These patients with AHT were more likely to be elder age, cardioembolic subtype, and to have higher National Institutes of Health Stroke Scale score before thrombolysis than patients without AHT. No significant difference was found on the odds of 7-day (95% CI:0.692 (0.218–2.195), (P = 0.532) or 90-day mortalities (95% CI:0.548 (0.237–1.268), P = 0.160) and modified Rankin Score(0–1) at 90-day (95% CI:0.798 (0.460–1.386), P = 0.423) or modified Rankin Score(0–2) at 90-day (95% CI:0.732 (0.429–1.253), P = 0.116) or modified Rankin Score(5–6) at 90-day (95% CI:0.375 (0.169–1.830), P = 0.116) between two groups. Conclusions Thrombolytic-related AHT does not deteriorate short-term and long-term clinical outcome. PMID:26619008

  14. 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

  15. Impact of cardiology referral: clinical outcomes and factors associated with physicians' adherence to recommendations

    PubMed Central

    Marques, André C; Calderaro, Daniela; Yu, Pai C; Gualandro, Danielle M; Carmo, Gabriel A L; Azevedo, Fernanda R; Pastana, Adriana F; Lima, Eneas M O; Monachini, Maristela; Caramelli, Bruno

    2014-01-01

    OBJECTIVES: Cardiology referral is common for patients admitted for non-cardiac diseases. Recommendations from cardiologists may involve complex and aggressive treatments that could be ignored or denied by other physicians. The purpose of this study was to compare the outcomes of patients who were given recommendations during cardiology referrals and to examine the clinical outcomes of patients who did not follow the recommendations. METHODS: We enrolled 589 consecutive patients who received in-hospital cardiology consultations. Data on recommendations, implementation of suggestions and outcomes were collected. RESULTS: Regarding adherence of the referring service to the recommendations, 77% of patients were classified in the adherence group and 23% were classified in the non-adherence group. Membership in the non-adherence group (p<0.001; odds ratio: 10.25; 95% CI: 4.45-23.62) and advanced age (p = 0.017; OR: 1.04; 95% CI: 1.01-1.07) were associated with unfavorable outcomes. Multivariate analysis identified four independent predictors of adherence to recommendations: follow-up notes in the medical chart (p<0.001; OR: 2.43; 95% CI: 1.48-4.01); verbal reinforcement (p = 0.001; OR: 1.86; 95% CI: 1.23-2.81); a small number of recommendation (p = 0.001; OR: 0.87; 95% CI: 0.80-0.94); and a younger patient age (p = 0.002; OR: 0.98; 95% CI: 0.96-0.99). CONCLUSIONS: Poor adherence to cardiology referral recommendations was associated with unfavorable clinical outcomes. Follow-up notes in the medical chart, verbal reinforcement, a limited number of recommendations and a patient age were associated with greater adherence to recommendations. PMID:25518017

  16. Recognition and Assessment of Eosinophilic Esophagitis: The Development of New Clinical Outcome Metrics

    PubMed Central

    Nguyen, Nathalie; Menard-Katcher, Calies

    2015-01-01

    Eosinophilic esophagitis (EoE) is a chronic, food-allergic disease manifest by symptoms of esophageal dysfunction and dense esophageal eosinophilia in which other causes have been excluded. Treatments include dietary restriction of the offending allergens, topical corticosteroids, and dilation of strictures. EoE has become increasingly prevalent over the past decade and has been increasingly recognized as a major health concern. Advancements in research and clinical needs have led to the development of novel pediatric- and adult-specific clinical outcome metrics (COMs). These COMs provide ways to measure clinically relevant features in EoE and set the stage for measuring outcomes in future therapeutic trials. In this article, we review novel symptom measurement assessments, the use of radiographic imaging to serve as a metric for therapeutic interventions, recently developed standardized methods for endoscopic assessment, novel techniques to evaluate esophageal mucosal inflammation, and methods for functional assessment of the esophagus. These advancements, in conjunction with current consensus recommendations, will improve the clinical assessment of patients with EoE. PMID:27330494

  17. Angiogenesis genotyping and clinical outcome during regorafenib treatment in metastatic colorectal cancer patients.

    PubMed

    Giampieri, Riccardo; Salvatore, Lisa; Del Prete, Michela; Prochilo, Tiziana; D'Anzeo, Marco; Loretelli, Cristian; Loupakis, Fotios; Aprile, Giuseppe; Maccaroni, Elena; Andrikou, Kalliopi; Bianconi, Maristella; Bittoni, Alessandro; Faloppi, Luca; Demurtas, Laura; Montironi, Rodolfo; Scarpelli, Marina; Falcone, Alfredo; Zaniboni, Alberto; Scartozzi, Mario; Cascinu, Stefano

    2016-01-01

    Regorafenib monotherapy is a potential option for metastatic colorectal cancer patients. However, the lack of predictive factors and the severe toxicities related to treatment have made its use in clinical practice challenging. Polymorphisms of VEGF and its receptor (VEGFR) genes might regulate angiogenesis and thus potentially influence outcome during anti-angiogenesis treatment such as regorafenib. Aim of our study was to evaluate the role of VEGF and VEGFR genotyping in determining clinical outcome for colorectal cancer patients receiving regorafenib. We retrospectively collected clinical data and samples (tumour or blood) of 138 metastatic colorectal cancer patients treated with regorafenib. We analysed the correlation of different VEGF-A, VEGF-C and VEGFR-1,2,3 single nucleotide polymorphisms (SNPs) with patients' progression-free survival (PFS) and overall survival (OS). Results from angiogenesis genotyping showed that only VEGF-A rs2010963 maintained an independent correlation with PFS and OS. Among clinical factors only ECOG PS was independently correlated with OS, whereas no correlation with PFS was evident. Grouping together those results allowed further patients stratification into 3 prognostic groups: favourable, intermediate and unfavourable. VEGF-A rs2010963 genotyping may represent an important tool for a more accurate selection of optimal candidates for regorafenib therapy. PMID:27117754

  18. Angiogenesis genotyping and clinical outcome during regorafenib treatment in metastatic colorectal cancer patients

    PubMed Central

    Giampieri, Riccardo; Salvatore, Lisa; Del Prete, Michela; Prochilo, Tiziana; D’Anzeo, Marco; Loretelli, Cristian; Loupakis, Fotios; Aprile, Giuseppe; Maccaroni, Elena; Andrikou, Kalliopi; Bianconi, Maristella; Bittoni, Alessandro; Faloppi, Luca; Demurtas, Laura; Montironi, Rodolfo; Scarpelli, Marina; Falcone, Alfredo; Zaniboni, Alberto; Scartozzi, Mario; Cascinu, Stefano

    2016-01-01

    Regorafenib monotherapy is a potential option for metastatic colorectal cancer patients. However, the lack of predictive factors and the severe toxicities related to treatment have made its use in clinical practice challenging. Polymorphisms of VEGF and its receptor (VEGFR) genes might regulate angiogenesis and thus potentially influence outcome during anti-angiogenesis treatment such as regorafenib. Aim of our study was to evaluate the role of VEGF and VEGFR genotyping in determining clinical outcome for colorectal cancer patients receiving regorafenib. We retrospectively collected clinical data and samples (tumour or blood) of 138 metastatic colorectal cancer patients treated with regorafenib. We analysed the correlation of different VEGF-A, VEGF-C and VEGFR-1,2,3 single nucleotide polymorphisms (SNPs) with patients’ progression-free survival (PFS) and overall survival (OS). Results from angiogenesis genotyping showed that only VEGF-A rs2010963 maintained an independent correlation with PFS and OS. Among clinical factors only ECOG PS was independently correlated with OS, whereas no correlation with PFS was evident. Grouping together those results allowed further patients stratification into 3 prognostic groups: favourable, intermediate and unfavourable. VEGF-A rs2010963 genotyping may represent an important tool for a more accurate selection of optimal candidates for regorafenib therapy. PMID:27117754

  19. 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. PMID:23543359

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

    PubMed Central

    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.

    2013-01-01

    Prime Time, a youth development intervention, aims to reduce multiple risk behaviors among adolescent girls seeking clinic services who are at high risk for pregnancy. The purpose of the current study was to examine whether Prime Time involvement produced changes in relational aggression, physical violence and related psychosocial and behavioral outcomes. Qualitative case exemplars illustrated social contexts of intervention participants with differing longitudinal patterns of relational 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 a very limited evidence base regarding effective approaches to preventing violence among high-risk adolescent girls. Findings suggest that offering youth development interventions through clinic settings hold promise in reducing violence risk among vulnerable youth. PMID:23543359

  1. 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 t