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Sample records for favorable clinical outcome

  1. Protein phosphatase methylesterase-1 (PME-1) expression predicts a favorable clinical outcome in colorectal cancer.

    PubMed

    Kaur, Amanpreet; Elzagheid, Adam; Birkman, Eva-Maria; Avoranta, Tuulia; Kytölä, Ville; Korkeila, Eija; Syrjänen, Kari; Westermarck, Jukka; Sundström, Jari

    2015-12-01

    Colorectal cancer (CRC) accounts for high mortality. So far, there is lack of markers capable of predicting which patients are at risk of aggressive course of the disease. Protein phosphatase-2A (PP2A) inhibitor proteins have recently gained interest as markers of more aggressive disease in certain cancers. Here, we report the role of PP2A inhibitor PME-1 in CRC. PME-1 expression was assessed from a rectal cancer patient cohort by immunohistochemistry, and correlations were performed for various clinicopathological variables and patient survival. Rectal cancer patients with higher cytoplasmic PME-1 protein expression (above median) had less recurrences (P = 0.003, n = 195) and better disease-free survival (DFS) than the patients with low cytoplasmic PME-1 protein expression (below median). Analysis of PPME-1 mRNA expression from TCGA dataset of colon and rectal adenocarcinoma (COADREAD) patient cohort confirmed high PPME1 expression as an independent protective factor predicting favorable overall survival (OS) (P = 0.005, n = 396) compared to patients with low PPME1 expression. CRC cell lines were used to study the effect of PME-1 knockdown by siRNA on cell survival. Contrary to other cancer types, PME-1 inhibition in CRC cell lines did not reduce the viability of cells or the expression of active phosphorylated AKT and ERK proteins. In conclusion, PME-1 expression predicts for a favorable outcome of CRC patients. The unexpected role of PME-1 in CRC in contrast with the oncogenic role of PP2A inhibitor proteins in other malignancies warrants further studies of cancer-specific function for each of these proteins.

  2. Clinical characteristics and favorable long-term outcomes for patients with idiopathic inflammatory myopathies: a retrospective single center study in China

    PubMed Central

    2011-01-01

    Background Little is known about the clinical features and true survival risk factors in Chinese Han population. We conducted the current study to investigate the clinical features, long-term outcome and true potential indicators associated with mortality of idiopathic inflammatory myopathies (IIM) in China. Methods We restrospectvely investigated 188 patients diagnosed with IIM at our hospital from January 1986 to April 2009. The primary outcome was determined with mortality. The secondary outcomes for survival patients were organ damage and disease activity, health status, and disability, which were assessed with Myositis Damage Index, Myositis Disease Activity Assessment Visual Analogue Scales, Health Assessment Questionnaire Disability Index, and the Modified Rankin Scale, respectively. Potential prognostic factors for mortality were analyzed with the multivariate Cox regression model. Results Mean age at disease onset was 43.8 ± 15.8 years and male to female ratio was 1:2.1 in this cohort. The 1-, 5-, 10-, 15- and 20-year survival rates were 93.6%, 88.7%, 81%, 73.6% and 65.6%. The independent predicators for mortality were age at disease onset [hazard ratio (HR):1.05, 95% CI 1.02 - 1.08], presence of cancer (HR:3.68, 95%CI 1.39 - 9.74), and elevated IgA level at diagnosis (HR:2.80, 95% CI 1.16-6.74). At the end of the follow-up, 29 patients manifested drug withdrawal within an average 4.1 years (range 0.5-15.2 year), most patients (85.9%) had no disease activity and 130 patients (83.4%) had no disability. Conclusions The long-term outcomes of IIM patients in our cohort have improved dramatically. Those patients most likely to survive had a high chance of reaching stable disease status, and obtained long-term or possibly permanent remission to a large extent. PMID:22070623

  3. Gestational Weight Gain in Japanese Women With Favorable Perinatal Outcomes

    PubMed Central

    Suzuki, Shunji

    2017-01-01

    Background We examined the optimal gestational weight gain (GWG) in the healthy Japanese women with favorable perinatal outcomes of singleton pregnancy. Methods We calculated the average GWG in the women whose height was 150 - 164 cm with favorable perinatal outcomes set for this study. The women were categorized to underweight, normal, overweight and obese based on the pre-pregnancy body mass index categories according to the Institute of Medicine guideline. Results The average GWG in the normal-weight women with the favorable perinatal outcomes was 11.4 ± 3.7 kg. It was not significantly different from that in the underweight and overweight women (12.0 ± 3.4 and 10.0 ± 4.8 kg) by Student’s t-test. The average GWG in the obese women was significantly lower than that in the other three groups (3.2 ± 2.2 kg, P < 0.01). Conclusion Based on the current results, the optimal GWG for the Japanese women without obesity was found to be 10 - 12 kg. PMID:27924177

  4. Clinical quality is independently associated with favorable bond ratings.

    PubMed

    Haydar, Ziad; Nicewander, David; Convery, Paul; Black, Michael; Ballard, David

    2010-01-01

    The relation between clinical quality and bond rating for nonprofit hospitals has been proposed but never fully studied. We analyzed the relation between bond rating, clinical quality measures (The Joint Commission/Centers for Medicare and Medicaid Services [CMS] core measures), and balance sheet and income statement financial measures of 236 hospitals across the United States that are rated by Moody's Investors Service and that reported clinical quality measures to CMS during the study period. We found a statistically significant relation between higher quality measures and more favorable bond ratings. This association remained significant after controlling for traditional financial parameters.

  5. Ostomy metastasis after pull endoscopic gastrostomy: a unique favorable outcome.

    PubMed

    Fonseca, Jorge; Adriana, Carla; Fróis-Borges, Miguel; Meira, Tânia; Oliveira, Gabriel; Santos, José Carlos

    2015-04-01

    Head and neck cancer (HNC) patients tend to develop dysphagia. In order to preserve the nutritional support, many undergo endoscopic gastrostomy (PEG). In HNC patients, ostomy metastasis is considered a rare complication of PEG, but there are no reports of successful treatment of these metastatic cancers. We report the case of a 65 years old pharyngeal/laryngeal cancer patient who underwent a PEG before the neck surgery. He was considered to be cured, resumed oral intake and the PEG tube was removed. Ten months after, he returned with a metastasis at the ostomy site. A block resection of the stomach and abdominal wall was performed. Two years after the abdominal surgery, he is free of disease. Although usually considered a rare complication of the endoscopic gastrostomy, ostomy metastasis may be more frequent than usually considered and the present case report demonstrates that these patients may have a favourable outcome.

  6. Resection of ictal high-frequency oscillations leads to favorable surgical outcome in pediatric epilepsy

    PubMed Central

    Fujiwara, Hisako; Greiner, Hansel M.; Lee, Ki Hyeong; Holland-Bouley, Katherine D.; Seo, Joo Hee; Arthur, Todd; Mangano, Francesco T.; Leach, James L.; Rose, Douglas F.

    2012-01-01

    Summary Purpose Intracranial electroencephalography (EEG) is performed as part of an epilepsy surgery evaluation when noninvasive tests are incongruent or the putative seizure-onset zone is near eloquent cortex. Determining the seizure-onset zone using intracranial EEG has been conventionally based on identification of specific ictal patterns with visual inspection. High-frequency oscillations (HFOs, >80 Hz) have been recognized recently as highly correlated with the epileptogenic zone. However, HFOs can be difficult to detect because of their low amplitude. Therefore, the prevalence of ictal HFOs and their role in localization of epileptogenic zone on intracranial EEG are unknown. Methods We identified 48 patients who underwent surgical treatment after the surgical evaluation with intracranial EEG, and 44 patients met criteria for this retrospective study. Results were not used in surgical decision making. Intracranial EEG recordings were collected with a sampling rate of 2,000 Hz. Recordings were first inspected visually to determine ictal onset and then analyzed further with time-frequency analysis. Forty-one (93%) of 44 patients had ictal HFOs determined with time-frequency analysis of intracranial EEG. Key Findings Twenty-two (54%) of the 41 patients with ictal HFOs had complete resection of HFO regions, regardless of frequency bands. Complete resection of HFOs (n = 22) resulted in a seizure-free outcome in 18 (82%) of 22 patients, significantly higher than the seizure-free outcome with incomplete HFO resection (4/19, 21%). Significance Our study shows that ictal HFOs are commonly found with intracranial EEG in our population largely of children with cortical dysplasia, and have localizing value. The use of ictal HFOs may add more promising information compared to interictal HFOs because of the evidence of ictal propagation and followed by clinical aspect of seizures. Complete resection of HFOs is a favorable prognostic indicator for surgical outcome. PMID

  7. Perceived Distributive Fairness of EU Transfer Payments, Outcome Favorability, Identity, and EU-Tax Compliance.

    PubMed

    Hartner, Martina; Rechberger, Silvia; Kirchler, Erich; Wenzel, Michael

    2011-01-01

    In a representative UK study (N = 1000) the link between distributive fairness perceptions, outcome favorability, identity, and tax compliance was researched in the context of European transfer payments. Results showed that both forms of tax compliance (i.e., individual and collective EU-tax compliance) were influenced by perceived distributive fairness judgments of EU transfer payments. Fairness itself was related to perceived outcome favorability (i.e., whether their own nation benefits from the EU in financial as well as socio-political terms). Additionally, national identifiers (i.e., people identifying with their own nation, but not with Europe) perceived EU membership as unbeneficial in financial as well as in socio-political terms and thus considered the transfer payments as less fair. Dual identifiers (i.e., people identifying with their own nation and with Europe) perceived the socio-political outcomes from EU membership as more beneficial and thus evaluated the transfer payments as fairer.

  8. Platelet count recovery after intravenous immunoglobulin predicts a favorable outcome in children with immune thrombocytopenia

    PubMed Central

    Ji, Mi Hong; Kim, Sung Jin; Ahn, Hyo Seop

    2016-01-01

    Background Childhood immune thrombocytopenic purpura (ITP) is a common acquired bleeding disorder. Even though most children recover, either spontaneously or with therapy, 10-20% of newly diagnosed ITP cases have a chronic course beyond 12 months. This study evaluated whether clinical and laboratory findings can predict the response to intravenous immunoglobulin (IVIG) and progression to persistent or chronic ITP in children. Methods During the period between March 2003 and June 2015, we retrospectively analyzed 72 children, newly diagnosed with ITP, who received IVIG treatment. Peripheral blood counts were obtained at diagnosis and at 1, 3, 6, and 12 months after IVIG treatment. Results After 6 months of IVIG treatment, 14 of 72 patients (19.4%) had persistent ITP, and after 12 months, 7 of 40 patients (17.5%) had chronic ITP. Age at diagnosis, gender, history of viral infection, or vaccination before disease onset were not statistically correlated with platelet recovery at 6 and 12 months. However, a platelet count recovery of ≥100×103/µL at 1 and 3 months was significantly correlated with platelet recovery at 6 (P<0.001 and P<0.001, respectively) and 12 (P=0.007 and P=0.004, respectively) months. Conclusion This study demonstrated that early platelet count recovery, at 1 and 3 months after IVIG treatment, predicts a short disease duration and a favorable outcome in children with newly diagnosed ITP. Further investigation in a larger group of patients is warranted to validate these findings. PMID:27382553

  9. Localization of post-transplant lymphoproliferative disorders to the stomach might be associated with favorable outcome: a systematic review.

    PubMed

    Khedmat, Hossein; Ghamar-Chehreh, Mohammad Ebrahim; Amini, Mohsen; Agah, Shahram; Taheri, Saeed

    2014-03-01

    Gastric localization of post-transplant lymphoproliferative disorders (PTLDs) is very rare. In this study, we aimed to accumulate existing data in the current literature to reveal the clinical, histopathological and prognostic specificities associated with gastric PTLDs and to find the best treatment strategies in this patient population. A comprehensive search was conducted for the available data in the current literature using Pubmed and Google scholar search engines for reports on gastric PTLD in renal transplant recipients. Data of different studies were standardized and entered into a database and analyzed. No statistically significant difference was found between gastric and non-gastric PTLD. Gastric PTLD was relatively more prevalent in female patients (P = 0.08) and showed a trend toward better outcome (P = 0.1) and less metastasis (P = 0.07). Surgical intervention and rituximab therapy were associated with a more favorable outcome (17% mortality). Our study showed that organ transplant recipients having gastric PTLD develop metastasis less frequently and tend to have a relatively more favorable outcome. Prospective studies with larger patient populations are needed to confirm or modify our results.

  10. Factors for Predicting Favorable Outcome of Percutaneous Epidural Adhesiolysis for Lumbar Disc Herniation

    PubMed Central

    Moon, Sang Ho; Lee, Jae Il; Cho, Hyun Seok; Shin, Jin Woo

    2017-01-01

    Background. Lower back pain is a common reason for disability and the most common cause is lumbar disc herniation. Percutaneous epidural adhesiolysis has been applied to relieve pain and increase the functional capacity of patients who present this condition. Objectives. In this study, we retrospectively evaluated the factors which predict the outcome of percutaneous epidural adhesiolysis in patients who were diagnosed with lumbar disc herniation. Methods. Electronic medical records of patients diagnosed with lumbar disc herniation who have received percutaneous epidural adhesiolysis treatment were reviewed. The primary outcome was the factors that were associated with substantial response of ≥4 points or ≥50% of pain relief in the numerical rating scale pain score 12 months after the treatment. Results. Multivariate logistic regression analysis demonstrated that the presence of high-intensity zone (HIZ) at magnetic resonance imaging was a predictor of substantial response to percutaneous epidural adhesiolysis for 12 months (P = 0.007). The presence of a condition involving the vertebral foramen was a predictor for unsuccessful response after 12 months (P = 0.02). Discussion and Conclusion. The presence of HIZ was a predictor of favorable long-term outcome after percutaneous epidural adhesiolysis for the treatment of lower back pain with radicular pain caused by lumbar disc herniation. PMID:28246488

  11. Time-Based Partitioning Model for Predicting Neurologically Favorable Outcome among Adults with Witnessed Bystander Out-of-Hospital CPA

    PubMed Central

    Abe, Toshikazu; Tokuda, Yasuharu; Cook, E. Francis

    2011-01-01

    Background Optimal acceptable time intervals from collapse to bystander cardiopulmonary resuscitation (CPR) for neurologically favorable outcome among adults with witnessed out-of-hospital cardiopulmonary arrest (CPA) have been unclear. Our aim was to assess the optimal acceptable thresholds of the time intervals of CPR for neurologically favorable outcome and survival using a recursive partitioning model. Methods and Findings From January 1, 2005 through December 31, 2009, we conducted a prospective population-based observational study across Japan involving consecutive out-of-hospital CPA patients (N = 69,648) who received a witnessed bystander CPR. Of 69,648 patients, 34,605 were assigned to the derivation data set and 35,043 to the validation data set. Time factors associated with better outcomes: the better outcomes were survival and neurologically favorable outcome at one month, defined as category one (good cerebral performance) or two (moderate cerebral disability) of the cerebral performance categories. Based on the recursive partitioning model from the derivation dataset (n = 34,605) to predict the neurologically favorable outcome at one month, 5 min threshold was the acceptable time interval from collapse to CPR initiation; 11 min from collapse to ambulance arrival; 18 min from collapse to return of spontaneous circulation (ROSC); and 19 min from collapse to hospital arrival. Among the validation dataset (n = 35,043), 209/2,292 (9.1%) in all patients with the acceptable time intervals and 1,388/2,706 (52.1%) in the subgroup with the acceptable time intervals and pre-hospital ROSC showed neurologically favorable outcome. Conclusions Initiation of CPR should be within 5 min for obtaining neurologically favorable outcome among adults with witnessed out-of-hospital CPA. Patients with the acceptable time intervals of bystander CPR and pre-hospital ROSC within 18 min could have 50% chance of neurologically favorable outcome. PMID:22194860

  12. Long-term prognosis of clinically early IgA nephropathy is not always favorable

    PubMed Central

    2014-01-01

    Background The long-term prognosis of clinically early IgA nephropathy (IgAN) patients remains to be clarified. We investigated the long-term outcomes of IgAN patients with an apparently benign presentation and evaluated prognostic factors for renal survival. Methods We included patients with biopsy-proven IgAN who had estimated glomerular filtration rates (eGFR) ≥60 mL/min/1.73 m2, normal blood pressure, and proteinuria <0.5 g/day at the time of biopsy. The primary outcome was progression to end-stage renal disease (ESRD). The secondary outcome was a 50% increase in serum creatinine level or an increase in proteinuria to >1 g/day. Results The analysis included 153 patients who met the inclusion criteria. At diagnosis, their median systolic blood pressure was 120 (110–130) mmHg, eGFR was 85.9 (74.9–100.1) mL/min/1.73 m2, and proteinuria was 0.25 (0.13–0.38) g/day. Of these, 4 patients died and 6 reached ESRD. The 30-year renal survival rate was 85.5%. Three patients had increased serum creatinine levels and 11 developed proteinuria. Remission was observed in 35 (22.9%) patients. A moderate or severe degree of interstitial fibrosis (adjusted odd ratio [OR] 5.93, 95% confidence interval [CI] 1.44–24.45, P = 0.014) and hypoalbuminemia (adjusted OR 6.18, 95% CI 1.20–31.79, P = 0.029) were independent predictors of the secondary outcome. Conclusions This study showed that the prognosis of early IgAN was not always favorable, even resulting in progression to ESRD in some cases. Hypoalbuminemia and interstitial fibrosis should also be considered important prognostic factors in clinically early IgAN patients. PMID:24946688

  13. Clinical outcome measures of psoriasis.

    PubMed

    Bonifati, C; Berardesca, E

    2007-01-01

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

  14. Predictive Factors of Survival and 6-Month Favorable Outcome of Very Severe Head Trauma Patients; a Historical Cohort Study

    PubMed Central

    Vathanalaoha, Karin; Oearsakul, Thakul; Tunthanathip, Thara

    2017-01-01

    Introduction: Very severe head trauma cases, defined as Glasgow Coma Scale (GCS) scores of less than 6, have a higher mortality rate and poorer outcome. The purpose of this study was to recognize factors associated with survival and 6-month favorable outcome of very severe head trauma patients presenting to emergency department. Methods: In this historical cohort study, the authors retrospectively reviewed medical records of head trauma patients who were admitted to the emergency department with post-resuscitation GCS scores of less than 6. Both univariate and multivariate analyses were used to test the association between various parameters with survival and 6-month outcome. Results: 103 cases with the mean age of 39 ± 16.5 years were studied (80% male). The overall survival rate was 41.7% and the rate of 6-month favorable outcome was 28.2%. In multivariate analysis, brisk pupil light reaction on admission and patent basal cistern on brain computed tomography (CT) scan were significant factors associated with both survival (OR 5.20, 95% CI 1.57-17.246, p = 0.007 and OR 3.65, 95% CI 1.22-10.91, p=0.02 respectively) and favorable outcome (OR 4.07, 95% CI 1.35-12.24, p=0.01 and OR 3.54, 95% CI 1.22-10.26, p 0.02), respectively. Conclusion: Based on the results of present study, the survival rate of patients with very severe head trauma (GCS < 6) was 41.7%. The strong predictors of survival and 6-month favorable outcome of these patients were brisk pupillary reactivity and patent cistern on brain CT scan. It seems that very severe head trauma patients still have a reasonable chance to survive and aggressive management should be continued. PMID:28286831

  15. Long-term clinical outcome of neonatal EEG findings.

    PubMed

    Almubarak, Salah; Wong, Peter K H

    2011-04-01

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

  16. Epithelial splicing regulatory protein 1 and 2 paralogues correlate with splice signatures and favorable outcome in human colorectal cancer

    PubMed Central

    Deloria, Abigail J.; Höflmayer, Doris; Kienzl, Philip; Łopatecka, Justyna; Sampl, Sandra; Klimpfinger, Martin; Braunschmid, Tamara; Bastian, Fabienne; Lu, Lingeng; Marian, Brigitte; Stättner, Stefan; Holzmann, Klaus

    2016-01-01

    ESRPs are master splice regulators implicated in alternative mRNA splicing programs important for epithelial-mesenchymal transition (EMT) and tumor progression. ESRP1 was identified in some tumors as good or worse predictor of outcome, but in colorectal cancer (CRC) the prognostic value of ESRPs and relation with mesenchymal splice variants is not clear. Here, we studied 68 CRC cases, compared tissue expression of ESRPs with clinical data and with EMT gene splice patterns of conditional CRC cells with deficient ESRP1 expression. Around 72% of patients showed global decreased transcript expression of both ESRPs in tumor as compared to matched non-neoplastic colorectal epithelium. Reduction of ESRP1 in tumor cells was evaluated by immunohistochemistry, associated with microsatellite stability and switch to mesenchymal splice signatures of FGFRs, CD44, ENAH and CTNND1(p120-catenin). Expression of ESRPs was significantly associated with favorable overall survival (log-rank test, P=0.0186 and 0.0408), better than prognostic stratification by tumor staging; and for ESRP1 confirmed with second TCGA cohort (log-rank test, P=0.0435). Prognostic value is independent of the pathological stage and microsatellite instability (ESRP1: HR=0.36, 95%CI 0.15–0.91, P=0.032; ESRP2: HR=0.23, 95%CI 0.08–0.65, P=0.006). Our study supports the role of ESRP1 as tumor suppressor and strongly suggests that ESRPs are candidate markers for early detection, diagnosis, and prognosis of CRC. PMID:27650542

  17. HHV8/EBV Coinfection Lymphoproliferative Disorder: Rare Entity with a Favorable Outcome

    PubMed Central

    Chelly, Beya; Kilani, Houda; Charfi, Lamia; Douggaz, Amel; Chatti, Samia; Chelbi, Emna

    2017-01-01

    HHV8/EBV-associated germinotropic lymphoproliferative disorder (GLD) is a challenging diagnosis given its rarity, the particular clinical presentation, and the lack of expression of markers usually used in establishing hematopoietic lineage. We report a new case of HHV8/EBV GLD in an immunocompetent 78-year-old woman. The diagnosis was made in an incidentally discovered lymphadenopathy. Histological examination showed a nodular lymphoid proliferation centered by aggregates of atypical plasmablastic cells admixed with small lymphoid cells. Tumor cells were strongly positive with EMA, HHV8, LMP1, CD38, CD138, and kappa light chains. They were negative with common lymphoma-associated markers (CD20, CD3, CD15, CD30, CD10, and bcl2). In situ hybridization confirmed the monotypic kappa light chains and the EBV infection (EBER+). A polyclonal pattern of Ig gene rearrangement was detected by PCR analysis. In the adjacent lymph node parenchyma, some germinal centers mimicked Castleman disease. In this case, the differential diagnosis was discussed with an early stage of large B-cell lymphoma arising in HHV8-associated multicentric Castleman disease. The clinical presentation, the immunophenotype, and the molecular results helped to make the accurate diagnosis. Through the review of the nine previously reported cases in literature, we discuss the clinical and pathologic features and the differential diagnosis of HHV8/EBV GLD. PMID:28280640

  18. Prognostic factors for a favorable outcome after varicocele repair in adolescents and adults.

    PubMed

    Samplaski, Mary K; Jarvi, Keith A

    2016-01-01

    The effect of varicocele repair on male fertility remains controversial. It would be helpful to determined which men would benefit most from varicocele repair, and target repair efforts at those individuals. A detailed review of the literature on prognostic factors for varicocele repair was performed using the PubMed NLM database. We found that the best predictor of postvaricocelectomy semen parameters is the preoperative semen parameters. The greatest improvements in semen parameters were found in men with larger varicoceles. While there is controversy, higher testosterone, younger age and larger testis size, in some studies predict for improvements in semen parameters postvaricocelectomy. A nomogram has been developed to predict the postvaricocelectomy semen parameters based on the preoperative semen parameters, varicocele grade and the age of the man (www.fertilitytreatmentresults.com). Limited data consistently demonstrates the greatest improvements in DNA fragmentation rates in men with higher baseline DNA fragmentation rates. With respect to reproductive outcomes, higher baseline sperm density consistently predicts for natural pregnancy or assisted reproductive technology (ART) pregnancy rates. In addition, varicocele repair does seem to reduce the need for more invasive modalities of ART. In conclusion, we can now start to use specific parameters such as baseline semen quality, varicocele grade and patient age to predict post-repair semen quality and fertility potential following varicocelectomy.

  19. Prognostic factors for a favorable outcome after varicocele repair in adolescents and adults

    PubMed Central

    Samplaski, Mary K; Jarvi, Keith A

    2016-01-01

    The effect of varicocele repair on male fertility remains controversial. It would be helpful to determined which men would benefit most from varicocele repair, and target repair efforts at those individuals. A detailed review of the literature on prognostic factors for varicocele repair was performed using the PubMed NLM database. We found that the best predictor of postvaricocelectomy semen parameters is the preoperative semen parameters. The greatest improvements in semen parameters were found in men with larger varicoceles. While there is controversy, higher testosterone, younger age and larger testis size, in some studies predict for improvements in semen parameters postvaricocelectomy. A nomogram has been developed to predict the postvaricocelectomy semen parameters based on the preoperative semen parameters, varicocele grade and the age of the man (www.fertilitytreatmentresults.com). Limited data consistently demonstrates the greatest improvements in DNA fragmentation rates in men with higher baseline DNA fragmentation rates. With respect to reproductive outcomes, higher baseline sperm density consistently predicts for natural pregnancy or assisted reproductive technology (ART) pregnancy rates. In addition, varicocele repair does seem to reduce the need for more invasive modalities of ART. In conclusion, we can now start to use specific parameters such as baseline semen quality, varicocele grade and patient age to predict post-repair semen quality and fertility potential following varicocelectomy. PMID:26732108

  20. Rhinocerebral zygomycosis: an increasingly frequent challenge: update and favorable outcomes in two cases.

    PubMed

    Islam, Mohammed N; Cohen, Donald M; Celestina, Leslie J; Ojha, Junu; Claudio, Reinaldo; Bhattacharyya, Indraneel B

    2007-11-01

    Zygomycosis or mucormycosis is an increasingly frequent life-threatening infection caused by opportunistic fungal organisms of the class Zygomycetes. The pathognomonic feature is the presence of invasive aseptate mycelia that are larger than other filamentous fungi with the hyphae exhibiting right angle and haphazard branching. Usually classified as rhinocerebral, disseminated, and cutaneous types, this classification serves as important predictor of pathogenesis and outcome. These occur mostly in immunosuppressed patients including individuals with diabetes (43% exhibit the rhino-cerebral form) and patients with organ transplants and hematologic malignancies. Without early aggressive treatment, the disease follows a dismal and fatal course. The prognosis has not shown any appreciable change in the past 40 years with a stagnant mortality rate of 44%. We present 2 cases of rhinocerebral zygomycosis (RCZ), in a 58-year-old male and a 63-year-old female; both were poorly controlled diabetic patients with maxillary lesions suggestive of osteomyelitis. The patients were leading a near normal life with minimal discomfort or signs and symptoms of underlying mycosis. Most of the health care professionals treating these patients often overlooked the disease or recommended inadequate therapy. Despite long delays and inadequate initial therapy these patients survived with little outward morbidity. The prognosis for this condition may therefore be considered less dire than previously thought.

  1. Favorable outcome of Fournier gangrene in two patients with diabetes mellitus on continuous peritoneal dialysis.

    PubMed

    Vigil, Darlene; Regmi, Anil; Last, Reuben; Wiggins, Brenda; Sun, Yijuan; Servilla, Karen S; Fair, Joanna R; Massie, Larry; Tzamaloukas, Antonios H

    2014-01-01

    Fournier gangrene (FG), a form of necrotizing fasciitis of the perineum and genitals, with high morbidity and mortality in the general population, carries the additional risk of involvement of the peritoneal catheter tunnel and peritoneal cavity in patients on chronic peritoneal dialysis (PD). We describe two men with diabetes who developed FG in the course of PD. Computed tomography showed no extension of FG to the abdominal wall, and spent peritoneal dialysate was clear in both patients. Broad-spectrum antibiotic therapy with anaerobic coverage and early aggressive debridement followed by negative-pressure wound therapy and repeated debridement led to improvements in clinical status in both cases. Surgical closure and healing of the wound was achieved in one patient; the wound of the second patient is healing, but remains open. Both patients experienced prolonged hospitalization, with a serious decline in nutrition status. In patients on PD, FG can be treated successfully. However, additional measures are required to evaluate for potential involvement of the PD apparatus and the peritoneal cavity in the infectious process; and prolonged hospitalization, worsening nutrition, and multiple surgical interventions can result.

  2. Cinacalcet and Clinical Outcomes in Dialysis.

    PubMed

    Komaba, Hirotaka; Fukagawa, Masafumi

    2015-01-01

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

  3. Early tumor shrinkage as a predictor of favorable outcomes in patients with advanced pancreatic cancer treated with FOLFIRINOX

    PubMed Central

    Kubota, Yutaro; Tagawa, Teppei; Yamamoto, Taikan; Ikusue, Toshikazu; Uto, Yu; Miyashita, Kouichirou; Toshima, Hirokazu; Kobayashi, Kouji; Hisamatsu, Atsushi; Ichikawa, Wataru; Sekikawa, Takashi; Shimada, Ken; Sasaki, Yasutsuna

    2016-01-01

    There are several reports on the correlation between early tumor shrinkage (ETS) or depth of response (DpR) and survival in chemotherapies for colorectal cancer; however, few studies have investigated it in pancreatic cancer. We therefore investigated whether the ETS will predict outcomes in 59 patients with advanced pancreatic cancer treated with FOLFIRINOX therapy. The association of ETS with progression-free survival (PFS) and overall survival (OS) was evaluated but also we addressed to the correlation between outcomes and DpR. ETS was defined as a reduction ≥ 20% of target lesions' diameters measured at 6 to 8 weeks from treatment start. DpR was percentage of maximal tumor shrinkage observed at the nadir diameter compared with baseline. Among 47 evaluable patients for the ETS, 12 (25.5%) patients experienced ETS. The ETS was significantly associated with better PFS (9.0 vs. 4.2 months) as well as OS (24.0 vs. 9.1 months); moreover, the association had a statistically significance for PFS but a strong trend for OS in multivariate analysis. The DpR was statistically significantly but weakly associated with OS. In conclusion, this is the first report that the early response to chemotherapy may predict favorable outcomes in patients with advanced pancreatic cancer treated with FOLFIRINOX therapy. PMID:27634903

  4. Concentrative nucleoside transporter 3 as a prognostic indicator for favorable outcome of t(8;21)-positive acute myeloid leukemia patients after cytarabine-based chemotherapy.

    PubMed

    Song, Ju Han; Cho, Kyung-Min; Kim, Hyeoung-Joon; Kim, Yeo-Kyeoung; Kim, Nan Young; Kim, Hee-Je; Lee, Tae-Hyang; Hwang, Seung Yong; Kim, Tae Sung

    2015-07-01

    Although acute myeloid leukemia (AML) exhibits diverse responses to chemotherapy, patients harboring the t(8;21) translocation are part of a favorable risk group. However, the reason why this subgroup is more responsive to cytarabine-based therapy has not been elucidated. In the present study, we analyzed expression levels of cytarabine metabolism-related genes in patients diagnosed with AML with or without t(8;21) and investigated their correlation with clinical outcomes after cytarabine-based therapy. Among the 8 genes studied, expression of the concentrative nucleoside transporter 3 (CNT3) gene was significantly higher in t(8;21)-positive patients compared to the others in the test population and the validation cohort (P<0.001 in Mann-Whitney U test; P<0.002 in Pearson's correlation analysis). Additionally, in both multivariate and univariate analyses, t(8;21)-positive patients categorized in a higher CNT3 expression tertile had longer disease-free survival [hazard ratio (HR), 0.117; 95% confidence interval (CI), 0.025-0.557; P=0.008] and overall survival (HR, 0.062; 95% CI, 0.007-0.521; P=0.010) compared to t(8;21)-positive patients in a lower CNT3 expression tertile. Notably, these trends did not occur in t(8;21)-negative patients. Our results demonstrate that CNT3 expression is associated with overall favorable outcomes and is predictive of clinical outcomes in AML patients with t(8;21). This suggests that CNT3 expression can be used to optimize treatment strategies for AML patients.

  5. Conservative Management and Planned Surgery for Periviable Advanced Extrauterine Abdominal Pregnancy with Favorable Outcome: Report of Two Cases

    PubMed Central

    Harirah, Hassan M.; Smith, J. Michael; Dixon, C. Luke; Hankins, Gary D. V.

    2016-01-01

    Advanced abdominal pregnancy is an extremely rare condition that poses diagnostic and management challenges. A high index of suspicion and careful assessment of the patient's symptoms, supplemented with obstetric ultrasound, and magnetic resonance imaging, are crucial for timely diagnosis and management to prevent life-threatening complications. The presence of periviable fetuses in advanced abdominal pregnancies increases the challenge to achieve a balance between maternal and fetal benefits and risks. Early diagnosis and management decisions via a multidisciplinary approach and planned delivery are of paramount importance to minimize complications and achieve favorable maternal and fetal outcomes. Even in the setting of oligohydramnios and suspected preterm premature rupture of membranes, in-patient conservative management and an individualized planned surgical approach that includes removing or leaving the placenta in place are appropriate for managing the periviable abdominal pregnancy. PMID:27595049

  6. Coexpression of SFRP1 and WIF1 as a Prognostic Predictor of Favorable Outcomes in Patients with Colorectal Carcinoma

    PubMed Central

    Huang, Shiyong; Zhong, XiaoMing; Gao, Jun; Song, Rongfeng; Wu, Hongyu; Zi, Shuming; Yang, Shijie; Du, Peng; Cui, Long; Yang, Chun; Li, Zikang

    2014-01-01

    Colorectal tumorigenesis is ascribed to the activity of Wnt signaling pathway in a ligand-independent manner mainly through APC and CTNNB1 gene mutations and in a ligand-dependent manner through low expression of Wnt inhibitors such as WNT inhibitory factor 1 (WIF1) and secreted frizzled related protein 1 (SFRP1). In this study we found that WIF1 protein expression was increased and SFRP1 was decreased significantly in CRC tissue versus normal tissue, and high expression of WIF1 was associated with big tumor diameters and deep invasion, and loss of SFRP1 expression was associated with the left lesion site, deep invasion, and high TNM stage. Among the four expression patterns (WIF+/SFRP1+, WIF+/SFRP1−, WIF−/SFRP1+, and WIF−/SFRP1−) only coexpression of WIF1 and SFRP1 (WIF+/SFRP1+) was associated with favorable overall survival, together with low TNM stage, as an independent prognostic factor as shown in a multivariate survival model. The results indicated that WIF1 seemed to play an oncogenic role, while SFRP1 seemed to play an oncosuppressive role although both of them are secreted Wnt antagonists. Coexpression of SFRP1 and WIF1, rather than SFRP1 or WIF1 alone, could be used, together with low TNM stage, as a prognostic predictor of favorable outcomes in CRC. PMID:24949429

  7. Favorable effect of rehabilitation on balance in ankylosing spondylitis: a quasi-randomized controlled clinical trial.

    PubMed

    Demontis, Alessandra; Trainito, Sabina; Del Felice, Alessandra; Masiero, Stefano

    2016-03-01

    Balance impairment is a frequent and undertreated manifestation in ankylosing spondylitis, leading to increased risk of falls and lower quality of life. Our aim was to assess supervised training and home-based rehabilitation efficacy on balance improvement in ankylosing spondylitis subjects on biologic agents. This was a single-blinded, quasi-randomized parallel study in a single outpatient Rehabilitation Clinic of a tertiary referral center. Subjects with ankylosing spondylitis on biologic agents were assigned either to supervised training and home-based rehabilitation program (rehabilitation group) plus educational-behavioral therapy, or to educational-behavioral therapy alone (educational groups). The same therapist provided therapy. Outcome measures were assessed at baseline (T0), end of treatment (T1) and at 7-month follow-up (T2). Rheumatologic outcomes were Bath Ankylosing Spondylitis Metrology Index, Bath Ankylosing Spondylitis Functional Index and Bath Ankylosing Spondylitis Disease Activity Index. Balance parameters (anterior-posterior oscillation, latero-lateral oscillation, sway area, sway density and sway path) were evaluated by stabilometry in a condition of open and closed eyes. Forty-six subjects (36 M, 10 F) were enrolled. Demographic data and clinical status at baseline were comparable between the two groups (22 rehabilitation group, 20 educational group). Primary outcome was sway density that improved both at T1 (SDy: open eyes p = 0.003, closed eyes p = 0.004) and at T2 (SDx: open eyes p = 0.0015, closed eyes p = 0.032). A trend toward improvement in the rehabilitation group rather than in the educational group emerged for balance parameters, especially those measured with closed eyes (0.004 < p < 0.048 at T1 and 0.004 < p < 0.036 at T2). Supervised training and home exercise lead to balance improvement in people with ankylosing spondylitis. Eyes-closed trials show a more marked trend toward improvement, and this may suggest a

  8. 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

  9. Mutations in TLR/MYD88 pathway identify a subset of young chronic lymphocytic leukemia patients with favorable outcome.

    PubMed

    Martínez-Trillos, Alejandra; Pinyol, Magda; Navarro, Alba; Aymerich, Marta; Jares, Pedro; Juan, Manel; Rozman, María; Colomer, Dolors; Delgado, Julio; Giné, Eva; González-Díaz, Marcos; Hernández-Rivas, Jesús M; Colado, Enrique; Rayón, Consolación; Payer, Angel R; Terol, Maria José; Navarro, Blanca; Quesada, Victor; Puente, Xosé S; Rozman, Ciril; López-Otín, Carlos; Campo, Elías; López-Guillermo, Armando; Villamor, Neus

    2014-06-12

    Mutations in Toll-like receptor (TLR) and myeloid differentiation primary response 88 (MYD88) genes have been found in chronic lymphocytic leukemia (CLL) at low frequency. We analyzed the incidence, clinicobiological characteristics, and outcome of patients with TLR/MYD88 mutations in 587 CLL patients. Twenty-three patients (3.9%) had mutations, 19 in MYD88 (one with concurrent IRAK1 mutation), 2 TLR2 (one with concomitant TLR6 mutation), 1 IRAK1, and 1 TLR5. No mutations were found in IRAK2 and IRAK4. TLR/MYD88-mutated CLL overexpressed genes of the nuclear factor κB pathway. Patients with TLR/MYD88 mutations were significantly younger (83% age ≤50 years) than those with no mutations. TLR/MYD88 mutations were the most frequent in young patients. Patients with mutated TLR/MYD88 CLL had a higher frequency of mutated IGHV and low expression of CD38 and ZAP-70. Overall survival (OS) was better in TLR/MYD88-mutated than unmutated patients in the whole series (10-year OS, 100% vs 62%; P = .002), and in the subset of patients age ≤50 years (100% vs 70%; P = .02). In addition, relative OS of TLR/MYD88-mutated patients was similar to that in the age- and gender-matched population. In summary, TLR/MYD88 mutations identify a population of young CLL patients with favorable outcome.

  10. Intermediate and Longer-Term Outcomes From a Prospective Active-Surveillance Program for Favorable-Risk Prostate Cancer

    PubMed Central

    Tosoian, Jeffrey J.; Mamawala, Mufaddal; Epstein, Jonathan I.; Landis, Patricia; Wolf, Sacha; Trock, Bruce J.; Carter, H. Ballentine

    2015-01-01

    Purpose To assess long-term outcomes of men with favorable-risk prostate cancer in a prospective, active-surveillance program. Methods Curative intervention was recommended for disease reclassification to higher cancer grade or volume on prostate biopsy. Primary outcomes were overall, cancer-specific, and metastasis-free survival. Secondary outcomes were the cumulative incidence of reclassification and curative intervention. Factors associated with grade reclassification and curative intervention were evaluated in a Cox proportional hazards model. Results A total of 1,298 men (median age, 66 years) with a median follow-up of 5 years (range, 0.01 to 18.00 years) contributed 6,766 person-years of follow-up since 1995. Overall, cancer-specific, and metastasis-free survival rates were 93%, 99.9%, and 99.4%, respectively, at 10 years and 69%, 99.9%, and 99.4%, respectively, at 15 years. The cumulative incidence of grade reclassification was 26% at 10 years and was 31% at 15 years; cumulative incidence of curative intervention was 50% at 10 years and was 57% at 15 years. The median treatment-free survival was 8.5 years (range, 0.01 to 18 years). Factors associated with grade reclassification were older age (hazard ratio [HR], 1.03 for each additional year; 95% CI, 1.01 to 1.06), prostate-specific antigen density (HR, 1.21 per 0.1 unit increase; 95% CI, 1.12 to 1.46), and greater number of positive biopsy cores (HR, 1.47 for each additional positive core; 95% CI, 1.26 to 1.69). Factors associated with intervention were prostate-specific antigen density (HR, 1.38 per 0.1 unit increase; 95% CI, 1.22 to 1.56) and a greater number of positive biopsy cores (HR, 1.35 for one additional positive core; 95% CI, 1.19 to 1.53). Conclusion Men with favorable-risk prostate cancer should be informed of the low likelihood of harm from their diagnosis and should be encouraged to consider surveillance rather than curative intervention. PMID:26324359

  11. 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.

  12. 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.

  13. Favorable Outcomes of Chinese HCV-Related Cirrhotic Patients with Sustained Virological Response after Pegylated Interferon Plus Ribavirin Treatment

    PubMed Central

    Chen, You-ming; Zhang, Ting; Cai, Qing-xian; Zhang, Xiao-hong; Zhao, Zhi-xing

    2017-01-01

    Few studies have conducted follow-up investigations of the clinical course in HCV-related cirrhotic patients who achieved a sustained virological response (SVR) with pegylated interferon plus ribavirin treatment (PegIFN + RBV). We investigated the clinical course and laboratory data in a prospective cohort study enrolling HCV-related cirrhotic patients who received PegIFN + RBV between August 2008 and July 2013 in China. Complete blood counts, liver function tests, and HCV-RNA were serially examined. Liver-related complications were recorded. To detect hepatocellular carcinoma (HCC), alpha-fetoprotein assays, and ultrasound scans were repeated at 6-month intervals. Twenty-five patients were enrolled, including 8 patients with decompensation events before treatment. Eighteen patients achieved SVR with a mean follow-up period of 25.78 months. During the follow-up period, only one patient exhibited HCV-RNA positivity and no decompensation events were detected, but 4 patients developed HCC after SVR. APRI decreased more in patients with SVR than in patients with non-SVR (median, −1.33 versus 0.86, P < 0.001). The albumin levels and platelet counts significantly increased during the follow-up period after SVR (44.27 ± 4.09 versus 42.63 ± 4.37, P = 0.037 and 173.89 ± 87.36 versus 160.11 ± 77.97, P = 0.047). These data indicated that HCV-related cirrhotic patients with SVR after PegIFN + RBV may have a favorable clinical course and improvements in laboratory data. Moreover, HCC should be monitored. PMID:28232944

  14. Assessing depression outcomes in group practice clinics.

    PubMed Central

    Braswell, H R; Williamson, J W

    1979-01-01

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

  15. 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.

  16. 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

  17. Autoimmune lymphoproliferative syndrome in pregnancy: a case of favorable mother-fetal outcome in a well-controlled disease.

    PubMed

    Patti, Simona; Perrone, Giuseppina; De Pratti, Valentina; Quinti, Isabella; Milito, Cinzia; Brunelli, Roberto

    2015-03-01

    The autoimmune lymphoproliferative syndrome (ALPS) is a disorder of abnormal lymphocyte survival caused by the dysregulation of the Fas apoptotic pathway. The Fas gene is expressed at the maternal-fetal interface and is involved in the regulation of immune response and implantation. Altered Fas expression may result in altered apoptosis and, ultimately, affect both the immune response and implantation; it is in fact associated with recurrent pregnancy loss, preterm premature rupture of membranes and pre-eclampsia. Currently, there are over 500 cases of ALPS reported worldwide from various racial and ethnic backgrounds. Up to date, the published work contains no specific reports on pregnancy outcome in women affected by ALPS. We present a case of full-term uneventful pregnancy in a patient affected by ALPS. A specific clinical follow-up in a pregnant woman with primary immunologic disease is suggested.

  18. Liposomal bupivacaine and clinical outcomes.

    PubMed

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

    2014-03-01

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

  19. Do Clinical Evaluations in a Psychiatry Clerkship Favor Students with Positive Personality Characteristics?

    ERIC Educational Resources Information Center

    Chibnall, John T.; Blaskiewicz, Robert J.

    2008-01-01

    Objective: The authors examine associations of personality characteristics, National Board of Medical Examiners subject examination performance, and Objective Structured Clinical Examination performance with clinical evaluations of third-year medical students in a psychiatry clerkship. Methods: Students completed the Revised NEO Personality…

  20. Outcomes of Children With Favorable Histology Wilms Tumor and Peritoneal Implants Treated in National Wilms Tumor Studies-4 and -5

    SciTech Connect

    Kalapurakal, John A.; Green, Daniel M.; Haase, Gerald; Anderson, James R.; Dome, Jeffrey S.; Grundy, Paul E.

    2010-06-01

    Purpose: There are no published reports on the optimal management and survival rates of children with Wilms tumor (WT) and peritoneal implants (PIs). Methods and Materials: Among favorable histology WT patients enrolled in the National Wilms Tumor Study (NWTS)-4 and NWTS-5, 57 children had PIs at the time of nephrectomy. The median age was 3 years 5 months (range, 3 months to 14 years). The majority of children (42 of 57 [74%)] had Stage III tumors; 15 had Stage IV disease. All patients received multimodality therapy. Of 56 children who underwent primary surgery, 48 (84%) had gross total resection of all tumors. All patients received 3-drug chemotherapy with vincristine, dactinomycin, and doxorubicin. Whole-abdomen radiotherapy (RT) was used in 47 patients (82%), and in 50 patients (88%) the RT dose was 10.5 Gy. Results: After a median follow-up of 7.5 years, the overall abdominal and systemic tumor control rates were 97% and 93%, respectively. A comparative analysis between children with PIs and those without PIs showed no significant differences in the clinical characteristics between the two groups. The 5-year event-free survival rates with and without PIs were 90% (95% confidence interval, 78-96%) and 83% (95% confidence interval, 81-85%) respectively (p = 0.20). Conclusions: Multimodality therapy with surgery, whole-abdomen RT, and three-drug chemotherapy delivered according to the NWTS-4 and -5 protocols resulted in excellent abdominal and systemic tumor control rates. All children should be monitored in long-term surveillance programs for the early detection and management of therapy-related toxicities.

  1. 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."

  2. Cervical neuroblastoma in eleven infants--a tumor with favorable prognosis. Clinical and radiologic (US, CT, MRI) findings.

    PubMed

    Abramson, S J; Berdon, W E; Ruzal-Shapiro, C; Stolar, C; Garvin, J

    1993-01-01

    Cervical neuroblastoma, a disease primarily of infants, has a favorable prognosis. Eleven patients are reported. Clinical presentations (other than mass) included stridor and swallowing problems. Masses when felt were commonly mistaken for infectious adenitis. Imaging studies (US, CT, MRI) showed solid masses with vascular displacement and narrowing; intraspinal extension was absent though extension into the adjacent sites of mediastinum and skull occurred. Horner syndrome was seen in five patients with accompanying heterochromia iridis in one. Five tumors had calcification. A high index of suspicion will lead to biopsy and less delay in diagnosis once a mass is felt or imaged.

  3. Early-Stage Hyperoxia Is Associated with Favorable Neurological Outcomes and Survival after Severe Traumatic Brain Injury: A Post-Hoc Analysis of the Brain Hypothermia Study.

    PubMed

    Fujita, Motoki; Oda, Yasutaka; Yamashita, Susumu; Kaneda, Kotaro; Kaneko, Tadashi; Suehiro, Eiichi; Dohi, Kenji; Kuroda, Yasuhiro; Kobata, Hitoshi; Tsuruta, Ryosuke; Maekawa, Tsuyoshi

    2017-01-19

    The effects of hyperoxia on the neurological outcomes of patients with severe traumatic brain injury (TBI) are still controversial. We examined whether the partial pressure of arterial oxygen (PaO2) and hyperoxia were associated with neurological outcomes and survival by conducting post-hoc analyses of the Brain Hypothermia (B-HYPO) study, a multi-center randomized controlled trial of mild therapeutic hypothermia for severe TBI. The differences in PaO2 and PaO2/fraction of inspiratory oxygen (P/F) ratio on the 1st day of admission were compared between patients with favorable (n = 64) and unfavorable (n = 65) neurological outcomes and between survivors (n = 90) and deceased patients (n = 39). PaO2 and the P/F ratio were significantly greater in patients with favorable outcomes than in patients with unfavorable neurological outcomes (PaO2: 252 ± 122 vs. 202 ± 87 mm Hg, respectively, p = 0.008; P/F ratio: 455 ± 171 vs. 389 ± 155, respectively, p = 0.022) and in survivors than in deceased patients (PaO2: 242 ± 117 vs. 193 ± 75 mm Hg, respectively, p = 0.005; P/F ratio: 445 ± 171 vs. 370 ± 141, respectively, p = 0.018). Similar tendencies were observed in subgroup analyses in patients with fever control and therapeutic hypothermia, and in patients with an evacuated mass or other lesions (unevacuated lesions). PaO2 was independently associated with survival (odds ratio 1.008, p = 0.037). These results suggested that early-stage hyperoxia might be associated with favorable neurological outcomes and survival following severe TBI.

  4. A 3-year experience with necrotizing fasciitis: favorable outcomes despite operative delays in a busy acute care hospital.

    PubMed

    Pakula, Andrea M; Kapadia, Ravi; Freeman, Brandon; Skinner, Ruby A

    2012-10-01

    Necrotizing fasciitis is a rare severe soft tissue infection that has historically been associated with high mortality. We sought to evaluate our experience with necrotizing fasciitis focusing on outcomes based on timing of operative intervention. Our study hypothesis was that delays in surgical management would negatively impact outcomes. Fifty-four patients were identified for a retrospective chart review from January 2008 to January 2011. Data analysis included demographics, admission laboratory values, imaging results, examination findings, timing and nature of operations, length of stay (LOS), and outcomes. Surgical intervention in 12 hours or more was considered a delay in care. Our study cohort was high risk based on a high prevalence of intravenous drug abuse, diabetes mellitus, hypertension, and end-stage liver disease. The average time to surgical intervention was 18±25 hours and the overall mortality rate was 16 per cent. A delay to surgery did not impact mortality or the number of débridements and LOS. Mortality was high, 45 per cent, in patients requiring amputation. We observed a high-risk population managed with aggressive surgical care for necrotizing fasciitis. Our mortality was low compared with historical data and surgical delays did not impact outcomes. Those patients requiring amputation had worse outcomes.

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

    PubMed

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

    2006-07-01

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

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

    PubMed

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

    2011-11-01

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

  7. Impact of Patient Sex on Clinical Outcomes

    PubMed Central

    Teitsma, Xavier M.; van der Hoeven, Henk; Tamminga, Rob; de Bie, Rob A.

    2014-01-01

    Background: The Combined Quality Care Anterior Cruciate Ligament registry provides data for clinical research regarding primary anterior cruciate ligament (ACL) surgery. Purpose: To explore the data with regard to the clinical outcomes between sexes after ACL reconstruction in a Dutch population. Study Design: Cohort study; Level of evidence, 3. Methods: Data involving patients diagnosed with an ACL tear and eligible for surgery were recorded. Isokinetic muscle strength, functional muscle performance, and anterior-posterior translation of the knee joint were documented preoperatively and at 3, 6, 9, and 12 months postoperatively. Patients completed the Knee Injury and Osteoarthritis Outcome Score (KOOS), Lysholm, and Tegner rating scales during each examination using a web-based questionnaire. Results: Approximately 90% of ACL injuries occurred during sport activities. The mean (SD) age at surgery was 28 (11) years for both men and women, and the majority of patients were treated with hamstring tendon autografts (94%). Four percent received bone–patellar tendon–bone autografts, and 2% of the patients received other grafts. Preoperatively, the KOOS, Lysholm, and Tegner scores were significantly higher in males. Twelve months postoperatively, both sexes showed comparable isokinetic strength (P = .336), knee laxity (P = .680), and hop test for distance (P = .122) when comparing the injured with the uninjured side. Self-reported knee function was comparable between sexes as assessed by the KOOS (P = .202), Lysholm (P = .872), and Tegner (P = .767) questionnaires during the 12-month follow-up. Conclusion: One year after ACL surgery, all patients had improved greatly, showing only minor differences between sexes. The male group showed slightly better results when evaluating self-reported knee questionnaires. Comparable outcomes and knee function between sexes can therefore be presumed with patients who are treated with hamstring tendon autografts in a Dutch

  8. Clinical outcome measures in juvenile idiopathic arthritis.

    PubMed

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

    2016-04-18

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

  9. Vitamin D and Clinical Outcomes in Dialysis

    PubMed Central

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

    2016-01-01

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

  10. 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

  11. Favorable Outcomes of Pediatric Patients Treated With Radiotherapy to the Central Nervous System Who Develop Radiation-Induced Meningiomas

    SciTech Connect

    Galloway, Thomas J.; Indelicato, Daniel J.; Amdur, Robert J.; Swanson, Erika L.; Morris, Christopher G.; Marcus, Robert B.

    2011-01-01

    Purpose: To report the outcome of patients treated at the University of Florida who developed meningiomas after radiation to the central nervous system (CNS) for childhood cancer. Methods and Materials: We retrospectively identified 10 patients aged {<=}19 years who received radiotherapy to sites in the craniospinal axis and subsequently developed a meningioma. We report the histology of the radiation-induced meningioma, treatment received, and ultimate outcome among this cohort of patients. Results: Meningioma was diagnosed at a median of 23.5 years after completion of the primary radiation. Fifty percent of second meningiomas were World Health Organization Grade 2 (atypical) or higher. All cases were managed with a single modality: resection alone (n = 7), fractionated radiotherapy (n = 2), and stereotactic radiosurgery (n = 1). The actuarial event-free survival and overall survival rate at 5 years after treatment for a radiation-induced meningioma was 89%. Three patients who underwent resection for retreatment experienced a Grade 3 toxicity. Conclusions: Radiation-induced meningiomas after treatment of pediatric CNS tumors are effectively managed with single-modality therapy. Such late-effect data inform the overall therapeutic ratio and support the continued role of selective irradiation in managing pediatric CNS malignancies.

  12. Clinical Outcomes Following Revision Anterior Shoulder Stabilization

    PubMed Central

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

    2015-01-01

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

  13. 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.

  14. Favorable patient reported outcomes following IMRT for early carcinomas of the tonsillar fossa: Results from a symptom assessment study

    PubMed Central

    Gunn, GB; Hansen, CC; Garden, AS; Fuller, CD; Mohamed, ASRM; Morrison, WH; Frank, SJ; Beadle, BM; Phan, J; Chronowski, GM; Sturgis, EM; Lewis, CM; Lu, C; Hutcheson, KA; Mendoza, TR; Cleeland, CS; Rosenthal, DI

    2016-01-01

    Background A questionnaire-based study was conducted to assess long-term patient reported outcomes (PROs) following definitive IMRT-based treatment for early stage carcinomas of the tonsillar fossa. Methods: Participants had received IMRT with or without systemic therapy for squamous carcinoma of the tonsillar fossa (T1-2 and N0-2b) with a minimum follow-up of 2 years. Patients completed a validated head and neck cancer-specific PRO instrument, the MD Anderson Symptom Inventory-Head and Neck module (MDASI-HN). Symptoms were compared between treatment groups of interest and overall symptom burden was evaluated. Results Of 139 participants analyzed, 51% had received ipsilateral neck IMRT, and 62% single modality IMRT alone (no systemic therapy). There were no differences in mean individual symptom and interference ratings for those treated with bilateral versus ipsilateral neck IMRT alone. However, 40% of those treated with bilateral versus 25% of those treated with ipsilateral neck RT alone reported moderate-to-severe levels of dry mouth (p=0.03). Fatigue, numbness/tingling, and constipation were rated more severe for those who had received systemic therapy (p<0.05 for each), but absolute differences were small. Overall, 51% had no more than mild symptom ratings across all 22 symptoms assessed. Conclusions The long-term patient reported symptom profile in this cohort of tonsil cancer survivors treated with definitive IMRT-based treatment showed a majority of patients with no more than mild symptoms, low symptom interference, and provides an opportunity for future comparison studies with other treatment approaches. PMID:26403258

  15. Expression of group IIA phospholipase A2 is an independent predictor of favorable outcome for patients with gastric cancer.

    PubMed

    Wang, Xi; Huang, Chun-Jin; Yu, Guan-Zhen; Wang, Jie-Jun; Wang, Rui; Li, Yu-Mei; Wu, Qiong

    2013-10-01

    Growing evidence suggests that phospholipase A2 (PLA2) plays a pivotal role in tumorigenesis in human gastrointestinal cancer. One of the well-studied isoforms of PLA2, group IIA PLA2 (PLA2G2A), appears to exert its protumorigenic or antitumorigenic effects in a tissue-specific manner. The present study was designed to determine the expression profile and prognostic value of PLA2G2A in gastric cancer in a large Chinese cohort. By using real-time polymerase chain reaction, the amount of PLA2G2A messenger RNA in 60 pairs of fresh gastric tumors and adjacent noncancerous mucosa was measured. The immunostaining of PLA2G2A in 866 gastric cancers with paired noncancerous tissues was assayed. No expression of PLA2G2A was found in normal gastric mucosa, and focal expression of PLA2G2A was noticed in intestinal metaplasia, whereas significantly increased expression of PLA2G2A was observed in the cytoplasm of gastric cancer cells. Furthermore, the extent of PLA2G2A expression was associated with tumor size (P < .001), tumor differentiation (P = .001), T class (P < .001), N class (P < .001), and TNM stage (P < .001) of gastric cancer. Multivariate analysis showed that PLA2G2A expression was an independent predictor of survival for patients with gastric cancer (P = .024). Expression of PLA2G2A seems to be protective for patients with gastric cancer (hazard ratio, 1.423; 95% confidence interval, 1.047-1.935), and it may be a target for achieving better treatment outcomes.

  16. Intracerebral hemorrhage with a favorable outcome in a patient with childhood primary angiitis of the central nervous system.

    PubMed

    Silva, Marco Felipe; Feitosa, Ana Raquel; Paz, José A; Aikawa, Nádia Emi; Silva, Clovis A

    2016-01-01

    Childhood primary angiitis of the central nervous system (cPACNS) is a rare inflammatory brain disease of unknown etiology. Of note, brain hemorrhage has been rarely reported in cPACNS patients, generally associated with a delayed clinical diagnosis, or with a diagnosis only at necropsy. We present the case of a boy with cPACNS that previously suffered an ischemic stroke. At the age of 7 years and 10 months, he presented a sudden and severe headache, vomiting and reduction in consciousness level (Glasgow coma scale 7), requiring prompt tracheal intubation. Brain computed tomography demonstrated intraparenchymal hematoma in the right parieto-occipital lobe and a small focus of bleeding in the right frontal lobe, vasogenic edema, herniation of the uncus and a 10mm deviation to the left from the midline. C-reactive protein (9.2mg/dL) and von Willebrand factor (vWF) antigen (202%) were elevated. Decompressive craniotomy was performed and methylprednisolone and cyclophosphamide were administered. One week later, the patient had left hemiparesis without other sequelae. Importantly, motor deficits have been improving progressively. Our case reinforces the inclusion of this vasculitis as a differential diagnosis in children and adolescents with CNS hemorrhage.

  17. [Intracerebral hemorrhage with a favorable outcome in a patient with childhood primary angiitis of the central nervous system.

    PubMed

    Silva, Marco Felipe; Feitosa, Ana Raquel; Paz, José A; Aikawa, Nádia Emi; Silva, Clovis A

    2014-11-01

    Childhood primary angiitis of the central nervous system (cPACNS) is a rare inflammatory brain disease of unknown etiology. Of note, brain hemorrhage has been rarely reported in cPACNS patients, generally associated with a delayed clinical diagnosis, or with a diagnosis only at necropsy. We present the case of a boy with cPACNS that previously suffered an ischemic stroke. At the age of 7 years and 10 months, he presented a sudden and severe headache, vomiting and reduction in consciousness level (Glasgow coma scale 7), requiring prompt tracheal intubation. Brain computed tomography demonstrated intraparenchymal hematoma in the right parieto-occipital lobe and a small focus of bleeding in the right frontal lobe, vasogenic edema, herniation of the uncus and a 10mm deviation to the left from the midline. C-reactive protein (9.2mg/dL) and von Willebrand factor (vWF) antigen (202%) were elevated. Decompressive craniotomy was performed and methylprednisolone and cyclophosphamide were administered. One week later, the patient had left hemiparesis without other sequelae. Importantly, motor deficits have been improving progressively. Our case reinforces the inclusion of this vasculitis as a differential diagnosis in children and adolescents with CNS hemorrhage.

  18. Deferred radiotherapy and upfront procarbazine–ACNU–vincristine administration for 1p19q codeleted oligodendroglial tumors are associated with favorable outcome without compromising patient performance, regardless of WHO grade

    PubMed Central

    Hata, Nobuhiro; Yoshimoto, Koji; Hatae, Ryusuke; Kuga, Daisuke; Akagi, Yojiro; Suzuki, Satoshi O; Iwaki, Toru; Shono, Tadahisa; Mizoguchi, Masahiro; Iihara, Koji

    2016-01-01

    Recently updated phase III trials revealed the favorable effect of add-on procarbazine-lomustine-vincristine chemotherapy (CT) to radiotherapy (RT) in treating anaplastic oligodendrogliomas with 1p19q codeletion (codel). However, the underlying rationality of deferring RT and upfront CT administration for these tumors is yet to be elucidated. Here, we retrospectively analyzed the long-term outcome of our case series with oligodendroglial tumors treated with deferred RT and upfront procarbazine+nimustine+vincristine (PAV) in the introduction administration. We enrolled 36 patients with newly diagnosed oligodendroglial tumors (17, grade II and 19, grade III) treated during 1999–2012 and followed up for a median period of 69.0 months. Their clinical and genetic prognostic factors were analyzed, and progression-free survival, overall survival (OS), and deterioration-free survival (DFS) were evaluated. Regardless of the WHO grade, the 25 patients with 1p19q codel tumors never received RT initially, and of these 25, 23 received PAV treatment upfront. The 75% OS of patients with 1p19q codel tumor was 135.3 months (did not reach the median OS), indicating a favorable outcome. Multivariate analysis revealed that IDH mutation and 1p19q, not WHO grade, are independent prognostic factors; furthermore, IDH and 1p19q status stratified the cohort into 3 groups with significantly different OS. The DFS explained the prolonged survival without declining performance in patients with both grade II and III 1p19q codel tumors. Deferred RT and upfront PAV treatment for 1p19q codel oligodendrogliomas were associated with favorable outcomes without compromising performance status, regardless of WHO grade. PMID:27895504

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

    PubMed Central

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

    2016-01-01

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

  20. The clinical outcome of childhood masturbation.

    PubMed

    Unal, F

    2000-01-01

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

  1. Clinical Features and Outcome of Mucormycosis

    PubMed Central

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

    2014-01-01

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

  2. 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.

  3. Controlled outcome studies of child clinical hypnosis.

    PubMed

    Adinolfi, Barbara; Gava, Nicoletta

    2013-09-01

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

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

    PubMed

    Andrade, Chittaranjan

    2015-10-01

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

  5. Highly favorable outcome in BRCA-mutated metastatic breast cancer patients receiving high-dose chemotherapy and autologous hematopoietic stem cell transplantation.

    PubMed

    Boudin, L; Gonçalves, A; Sabatier, R; Moretta, J; Sfumato, P; Asseeva, P; Livon, D; Bertucci, F; Extra, J-M; Tarpin, C; Houvenaegel, G; Lambaudie, E; Tallet, A; Resbeut, M; Sobol, H; Charafe-Jauffret, E; Calmels, B; Lemarie, C; Boher, J-M; Viens, P; Eisinger, F; Chabannon, C

    2016-08-01

    Breast cancer carrying BRCA mutation may be highly sensitive to DNA-damaging agents. We hypothesized a better outcome for BRCA-mutated (BRCA(mut)) metastatic breast cancer (MBC) patients receiving high-dose chemotherapy and autologous hematopoietic stem cell transplantation (HDC AHSCT) versus unaffected BRCA (BRCA wild type; (BRCA(wt))) or patients without documented BRCA mutation (BRCA untested (BRCA(ut))). All female patients treated for MBC with AHSCT at Institut Paoli-Calmettes between 2003 and 2012 were included. BRCA(mut) and BRCA(wt) patients were identified from our institutional genetic database. Overall survival (OS) was the primary end point. A total of 235 patients were included. In all, 15 patients were BRCA(mut), 62 BRCA(wt) and 149 BRCA(ut). In multivariate analyses, the BRCA(mut) status was an independent prognostic factor for OS (hazard ratio (HR): 3.08, 95% confidence interval (CI): 1.10-8.64, P=0.0326) and PFS (HR: 2.52, 95% CI :1.29-4.91, P=0.0069). In this large series of MBC receiving HDC AHSCT, we report a highly favorable survival outcome in the subset of patients with documented germline BRCA mutations.

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

    PubMed Central

    2011-01-01

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

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

    PubMed

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

    2008-12-01

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

  8. Favorable outcomes of hydroxychloroquine in insulin resistance may be accomplished by adjustment of the endothelial dysfunction as well as the skewed balance of adipokines.

    PubMed

    Abdel-Hamid, Ahmed A M; Firgany, Alaa El-Din L

    2016-07-01

    Hydroxychloroquine (HCQ) has been demonstrated to reduce the risk to develop diabetes mellitus (DM). However no previous experimental study had investigated its effect on the structure of the endocrine pancreas, islets of Langerhans (IOL), in insulin resistance (IR). In addition, the mechanism by which HCQ can prevent DM is not well understood. In this study, we hypothesized that the possible favorable outcome of HCQ may be partly achieved by its molecular effect on the endothelial stress markers as well as on the imparied balance of the adipokines that usually accompanies IR. A total of 54 rats were divided equally into; control, high fat diet (HFD) and HFD+HCQ groups (received standard chow, HFD and HFD+HCQ respectively). After 12 weeks, samples from pancreas as well as visceral adipose tissue (VAT) were histologically studied for the consequent changes. In the HFD group, there were mild degenerative changes and expansion of the IOL accompanied with a significantly increased (p<0.05) β-cell area%, mass, proliferation and neogenesis as well as a significantly decreased (p<0.05) α-cell area% compared with the other groups. On combining HCQ with HFD, reversal of these changes along with correction of the impaired adipokines levels (leptin, adiponectin, resistin, visfatin and lipocalin-2) and significant decrease (p<0.05) of the vascular endothelial stress markers (sE-selectin, sICAM and sVICAM) were manifested compared with the HFD group. Therefore, HCQ favorable effects in IR may be attributed to relieving of the endothelial stress as well as normalization of the skewed balance of adipokines.

  9. 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.

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

    PubMed Central

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

    2016-01-01

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

  11. The presence of CXCR4+ CD1a+ cells at onset of Langerhans cell histiocytosis is associated with a less favorable outcome

    PubMed Central

    Quispel, Willemijn T.; Stegehuis-Kamp, Janine A.; Blijleven, Laura; Santos, Susy J.; Lourda, Magda; van den Bos, Cor; van Halteren, Astrid G.S.; Egeler, R. Maarten

    2016-01-01

    abstract Purpose: Langerhans Cell Histiocytosis (LCH) is a neoplastic disorder characterized by tissue accumulating CD1a+ histiocytes which frequently carry somatic mutations. Irrespective of mutation status, these LCH-cells display constitutively active kinases belonging to the MAPK pathway. We evaluated, in retrospect, the contribution of individual components of the MAPK-activating and chemotaxis-promoting TNF-CXCR4-CXCL12 axis to LCH manifestation and outcome. Experimental design: CXCR4, CXCL12 and TNF protein expression was immunohistochemically analyzed in 70 LCH-affected biopsies. The presence of CXCR4+CD1a+ cells in peripheral blood (PB) and/or bone marrow (BM) samples was evaluated by flowcytometry in 13 therapy-naive LCH-patients. Results: CXCL12 was detected in 68/70 (97%) biopsies. CXCR4+LCH-cells were present in 50/70 (71%) biopsies; their presence was associated with higher levels of intralesional TNF. Circulating CD1a+CXCR4+ cells were detected in 4/13 (31%) therapy-naïve LCH-patients which displayed BRAFV600E (2/4), MAP2K1 (1/4) or no (1/4) mutations in their tissues. These CD11c co-expressing CD1a+CXCR4+cells migrated to CXCL12 in chemotaxis assays. Lesional CXCR4+LCH-cells were detected in 18/20 cases who presented with LCH manifestation at multiple sites and in 5/23 (22%) patients who developed additional lesions after initially presenting with a single lesion. The CXCR4 status at onset proved to be an independent risk factor for LCH reactivation in multivariate analysis (odds ratio 10.4, p = 0.034). Conclusions: This study provides the first evidence that CXCR4 is involved in the homing and retention of LCH-cells in CXCL12-expressing tissues and qualifies CXCR4 as a candidate prognostic marker for less favorable disease outcome.

  12. Favorable outcome in non-infant children with MLL-AF4-positive acute lymphoblastic leukemia: a report from the Tokyo Children's Cancer Study Group.

    PubMed

    Tomizawa, Daisuke; Kato, Motohiro; Takahashi, Hiroyuki; Fujimura, Junya; Inukai, Takeshi; Fukushima, Takashi; Kiyokawa, Nobutaka; Koh, Katsuyoshi; Manabe, Atsushi; Ohara, Akira

    2015-11-01

    Unlike acute lymphoblastic leukemia (ALL) in infants, MLL gene rearrangement (MLL-r) is rare in ALL children (≥1 year old). The outcome and optimal treatment options for MLL-r ALL remain controversial. Among the 1827 children enrolled in the Tokyo Children's Cancer Study Group ALL studies L95-14, L99-15, L99-1502, L04-16, and L07-1602 (1995-2009), 25 MLL-r ALL patients (1.3 %) were identified. Their median age and leukocyte count at diagnosis was 2 years old (range 1-15 years) and 27,690/μL (range 1800-1,113,000/μL), respectively. All but one patient achieved complete remission (CR) after induction therapy, and 19 underwent allogeneic hematopoietic stem cell transplantation (HSCT) in first CR according to the protocol. The 5-year event-free survival (EFS) and overall survival (OS) rate were 60.0 % [standard error (SE), 9.7 %] and 64.0 % (SE 9.6 %), respectively. Notably, 9/12 cases with MLL-AF4-positive ALL are alive in continuous CR with a 75.0 % (SE 12.5 %) EFS rate. The causes of treatment failure were as follows: one induction failure, five relapses, and five transplant-related deaths. With intensive chemotherapy and allogeneic HSCT, favorable outcome of children (≥1 year old) with MLL-AF4-positive ALL was observed. However, considering the risk of acute and late toxicities associated with HSCT, its indication should be restricted.

  13. A CpG island methylator phenotype in acute myeloid leukemia independent of IDH mutations and associated with a favorable outcome.

    PubMed

    Kelly, A D; Kroeger, H; Yamazaki, J; Taby, R; Neumann, F; Yu, S; Lee, J T; Patel, B; Li, Y; He, R; Liang, S; Lu, Y; Cesaroni, M; Pierce, S A; Kornblau, S M; Bueso-Ramos, C E; Ravandi, F; Kantarjian, H M; Jelinek, J; Issa, J-Pj

    2017-01-31

    Genetic changes are infrequent in acute myeloid leukemia (AML) compared with other malignancies and often involve epigenetic regulators, suggesting that an altered epigenome may underlie AML biology and outcomes. In 96 AML cases including 65 pilot samples selected for cured/not-cured, we found higher CpG island (CGI) promoter methylation in cured patients. Expanded genome-wide digital restriction enzyme analysis of methylation data revealed a CGI methylator phenotype independent of IDH1/2 mutations we term AML-CGI methylator phenotype (CIMP) (A-CIMP(+)). A-CIMP was associated with longer overall survival (OS) in this data set (median OS, years: A-CIMP(+)=not reached, CIMP(-)=1.17; P=0.08). For validation we used 194 samples from The Cancer Genome Atlas interrogated with Illumina 450k methylation arrays where we confirmed longer OS in A-CIMP (median OS, years: A-CIMP(+)=2.34, A-CIMP(-)=1.00; P=0.01). Hypermethylation in A-CIMP(+) favored CGIs (OR: CGI/non-CGI=5.21), and while A-CIMP(+) was enriched in CEBPA (P=0.002) and WT1 mutations (P=0.02), 70% of cases lacked either mutation. Hypermethylated genes in A-CIMP(+) function in pluripotency maintenance, and a gene expression signature of A-CIMP was associated with outcomes in multiple data sets. We conclude that CIMP in AML cannot be explained solely by gene mutations (for example, IDH1/2, TET2), and that curability in A-CIMP(+) AML should be validated prospectively.Leukemia advance online publication, 31 January 2017; doi:10.1038/leu.2017.12.

  14. Favorable outcomes for both mother and baby are possible in pregnant women with Crimean-Congo hemorrhagic fever disease: a case series and literature review.

    PubMed

    Gozel, Mustafa Gokhan; Elaldi, Nazif; Engin, Aynur; Akkar, Ozlem Bozoklu; Bolat, Fatih; Celik, Cem

    2014-01-01

    To assess the impact of Crimean-Congo hemorrhagic fever (CCHF) infection during pregnancy on maternal and fetal outcomes, we present the clinical and laboratory findings and outcomes of 5 pregnant women with CCHF infection as well as fetal outcomes. We also reviewed previously reported cases with CCHF infection in pregnant women. All pregnant women with CCHF infection who had been hospitalized between August 2007 and September 2011 were included. The gestational ages at the time of CCHF infection were 8, 18, 20, 21 and 32 weeks. CCHF infection was acquired during the 1st trimester in only 1 case and resulted in spontaneous abortion. The other 4 pregnant women completely recovered, all reached a healthy full-term gestation and 4 term babies were born. All infants had normal birth weight and were found to be healthy on their first examination and follow-up. In the literature concerning CCHF infection in pregnancy, 8 published articles including case reports or case series and 1 poster presentation including 1 case could be accessed. In conclusion, there is a risk of vertical transmission of CCHF infection, and infections acquired early in gestation had a poor prognosis for the fetus.

  15. Upfront Systemic Chemotherapy and Short-Course Radiotherapy with Delayed Surgery for Locally Advanced Rectal Cancer with Distant Metastases: Outcomes, Compliance, and Favorable Prognostic Factors

    PubMed Central

    Kim, Tae Hyung; Ahn, Joong Bae; Jung, Minkyu; Kim, Tae Il; Kim, Hoguen; Shin, Sang Joon; Kim, Nam Kyu

    2016-01-01

    Purpose/Objective(s) Optimal treatment for locally advanced rectal cancer (LARC) with distant metastasis remains elusive. We aimed to evaluate upfront systemic chemotherapy and short-course radiotherapy (RT) followed by delayed surgery for such patients, and to identify favorable prognostic factors. Materials/Methods We retrospectively reviewed 50 LARC patients (cT4 or cT3, <2 mm from the mesorectal fascia) with synchronous metastatic disease. The primary endpoint was progression-free survival (PFS). The secondary endpoints were overall survival, treatment-related toxicity, and compliance. We considered P values <0.05 significant. Results At 22 months median follow-up, the median PFS time was 16 months and the 2-year PFS rate was 34.8%. Thirty-five patients who received radical surgery for primary and metastatic tumors were designated the curable group. Six patients with clinical complete response (ypCR) of metastases who underwent radical surgery for only the primary tumor were classified as potentially curable. Nine patients who received no radical surgery (3 received palliative surgery) were deemed the palliative group. The ypCR rate among surgery patients was 13.6%. PFS rates for the curable or potentially curable groups were significantly longer than that of the palliative group (P<0.001). On multivariate analysis, solitary organ metastasis and R0 status were independent prognostic factors for PFS. Conclusions These findings demonstrated that a strong possibility that upfront chemotherapy and short-course RT with delayed surgery are an effective alternative treatment for LARC with potentially resectable distant metastasis, owing to achievement of pathologic down-staging, R0 resection, and favorable compliance and toxicity, despite the long treatment duration. PMID:27536871

  16. 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

  17. Clinical Outcome Metrics for Optimization of Robust Training

    NASA Technical Reports Server (NTRS)

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

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

    PubMed Central

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

    2017-01-01

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

  19. 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.

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

    SciTech Connect

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

    2012-02-01

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

  1. 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…

  2. 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"…

  3. Outpatient clinic referrals and their outcome.

    PubMed

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

    1992-03-01

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

  4. Air Embolism: Diagnosis, Clinical Management and Outcomes

    PubMed Central

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

    2017-01-01

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

  5. Friend or foe: can activating mutations in NOTCH1 contribute to a favorable treatment outcome in patients with T-ALL?

    PubMed

    Goldshtein, Aviya; Berger, Michael

    2014-01-01

    T-cell acute lymphoblastic leukemia (T-ALL) is an aggressive malignancy of thymocytes. Despite significant improvement in the treatment of T-ALL, approximately 20% of children and most adults succumb to resistant or relapsed disease. Transformation events occur during crucial steps of thymocyte development and have been related to the expression of certain oncogenes such as TAL2, TLX1, LYL1, LMO1, and NOTCH1. Mutations that lead to constitutive activation of NOTCH1 are most commonly found in human patients with T-ALL. Moreover, overexpression of the intracellular portion of NOTCH1 can lead to the initiation of T-ALL in mouse models. These findings suggest that NOTCH1 may promote tumorigenesis through the regulation of differentiation of leukemic cells, and, potentially, of leukemia-initiating cell identity and function. Multiple studies and clinical trials aimed at targeting NOTCH1 in T-ALL or using NOTCH1 mutations as a prognostic tool are currently underway. Recent studies unexpectedly found that activating mutations in NOTCH1 are correlated with better treatment outcome. Here we review these studies and discuss possible explanations for these findings.

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

    PubMed

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

    2007-01-01

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

  7. Levothyroxine Poisoning - Symptoms and Clinical Outcome.

    PubMed

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

    2015-10-01

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

  8. Improving Treatment Trial Outcomes for Rett Syndrome: The Development of Rett-specific Anchors for the Clinical Global Impression Scale.

    PubMed

    Neul, Jeffrey L; Glaze, Daniel G; Percy, Alan K; Feyma, Tim; Beisang, Arthur; Dinh, Thuy; Suter, Bernhard; Anagnostou, Evdokia; Snape, Mike; Horrigan, Joseph; Jones, Nancy E

    2015-11-01

    Rett syndrome is a genetically based neurodevelopmental disorder. Although the clinical consequences of Rett syndrome are profound and lifelong, currently no approved drug treatments are available specifically targeted to Rett symptoms. High quality outcome measures, specific to the core symptoms of a disorder are a critical component of well-designed clinical trials for individuals with neurodevelopmental disorders. The Clinical Global Impression Scale is a measure of global clinical change with strong face validity that has been widely used as an outcome measure in clinical trials of central nervous system disorders. Despite its favorable assay sensitivity in clinical trials, as a global measure, the Clinical Global Impression Scale is not specific to the signs and symptoms of the disorder under study. Development of key anchors for the scale, specific to the disorder being assessed, holds promise for enhancing the validity and reliability of the measure for disorders such as Rett syndrome.

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

    PubMed

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

    2015-06-01

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

  10. Clinical outcome in patients with small-intestinal non-Hodgkin lymphoma.

    PubMed

    Kako, Shinichi; Oshima, Kumi; Sato, Miki; Terasako, Kiriko; Okuda, Shinya; Nakasone, Hideki; Yamazaki, Rie; Tanaka, Yukie; Tanihara, Aki; Kawamura, Yutaka; Kiyosaki, Hirokazu; Higuchi, Takakazu; Nishida, Junji; Konishi, Fumio; Kanda, Yoshinobu

    2009-10-01

    The clinical features and outcome of small intestinal lymphoma remain unclear. We retrospectively analyzed 23 patients who had non-Hodgkin lymphoma with a small intestinal lesion. With a median follow-up of 37 months, the 5-year overall survival and failure-free survival (FFS) were 64% and 60%, respectively. In a univariate analysis, a worse performance status at the start of treatment and the occurrence of abdominal symptoms or perforation during treatment were associated with poor survival. Perforation often resulted in a dismal prognosis in patients with uncontrollable lymphoma, but not in patients with lymphoma in remission. The role of surgery in small intestinal lymphoma remains equivocal. In the current study, surgery before other therapies favorably influenced FFS, and all patients who underwent complete resection of the small intestinal lesion had extremely favorable results. Further studies are warranted to establish optimal therapeutic strategies.

  11. Heparin monitoring: clinical outcome and practical approach.

    PubMed

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

    2016-12-01

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

  12. 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.

  13. 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

  14. Aggressive Chordomas: Clinical Outcome of 13 Patients.

    PubMed

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

    2017-03-01

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

  15. Outcome Measures in Clinical Trials for Multiple Sclerosis.

    PubMed

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

    2017-02-09

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

  16. Germline determinants of clinical outcome of cutaneous melanoma.

    PubMed

    Vogelsang, Matjaz; Wilson, Melissa; Kirchhoff, Tomas

    2016-01-01

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

  17. Outcomes of a Nurse-Managed Diabetes Foot Clinic

    DTIC Science & Technology

    2016-06-07

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

  18. 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

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

    PubMed Central

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

    2007-01-01

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

  20. 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

  1. 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…

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

    PubMed Central

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

    2016-01-01

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

  3. Long QT syndrome: how effective therapy in a single patient favorably influenced the long-term clinical course and genetic understanding of this hereditary disorder.

    PubMed

    Lowengrub, Katherine M; Moss, Deborah R; Moss, David A; Moss, Arthur J

    2015-01-01

    The story of the long QT syndrome involved a chance interaction that took place in 1957 when Dr. Moss was shown a unique series of ECGs with a prolonged QT interval in a young deaf boy whose recurrent syncope culminated in sudden death. Who could have predicted that this clinical experience would lead to innovative and effective new therapy for a patient with the long QT syndrome several years later and the subsequent formation of the International Long QT Registry? This Registry has stimulated interactions among and between patients and physicians and has enhanced collaborations involving clinical, genetic, and basic-science investigators. The net result has been a significant improvement in the diagnosis, treatment, and outcome of patients with the long QT syndrome and an overall advancement in the science of medicine - two of the many satisfactions that physicians can experience in the clinical practice of medicine.

  4. 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

  5. Favorable short-term outcome of HCV-positive liver graft with bridging fibrosis: A plea for very early viral eradication.

    PubMed

    Martini, Silvia; Salizzoni, Mauro; David, Ezio; Tandoi, Francesco; Fonio, Paolo; Delsedime, Luisa; Strona, Silvia; Dell Olio, Dominic; Saracco, Giorgio Maria; Romagnoli, Renato

    2016-12-16

    We report the first case of an HCV-positive recipient who was transplanted with an HCV-positive graft with portal-portal bridging fibrosis. Curbing HCV infection immediately after liver transplant with direct-acting antivirals, resulted in an excellent 9-month outcome. This article is protected by copyright. All rights reserved.

  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.

  7. 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

  8. Resection of ictal high frequency oscillations is associated with favorable surgical outcome in pediatric drug resistant epilepsy secondary to tuberous sclerosis complex.

    PubMed

    Fujiwara, Hisako; Leach, James L; Greiner, Hansel M; Holland-Bouley, Katherine D; Rose, Douglas F; Arthur, Todd; Mangano, Francesco T

    2016-10-01

    Resective epilepsy surgery can improve seizures when the epileptogenic zone (EZ) is limited to a well-defined region. High frequency oscillations (HFO) have been recognized as having a high association with the seizure onset zone. Therefore, we retrospectively identified ictal HFOs and determined their relationship to specific intracranial features of cortical tubers in children with TSC who underwent resective surgery. We identified 14 patients with drug resistant epilepsy secondary to TSC who underwent subdural grid and strip implantation for presurgical evaluation and subsequent resection with adequate post-surgical follow-up. We aimed to determine the relationship between ictal HFOs, post-resection outcome and neuroimaging features in this population. The largest tuber was identified in all 14 patients (100%). Four patients (29%) had unusual tubers. HFOs were observed at ictal onset in all 14 patients. Seven of 10 patients with complete resection of HFOs were seizure free. The better seizure outcome (ILAE=1-3) was achieved with complete HFO resection regardless of the unique TSC structural features (p=0.0140). Our study demonstrates the presence of ripple and fast ripple range HFOs at ictal onset in children with TSC. Our study showed that complete HFO resection led to the better surgical outcome, independent of MR imaging findings.

  9. 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

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

    PubMed Central

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

    2003-01-01

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

  11. 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

  12. 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.

  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. Clinical features and surgical outcomes of primary canaliculitis with concretions

    PubMed Central

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

    2017-01-01

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

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

    PubMed Central

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

    2016-01-01

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

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

    PubMed

    Rosenstein, Alan H; O'Daniel, Michelle

    2005-01-01

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

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

    PubMed Central

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

    2014-01-01

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

  18. Clinical Characteristics and Treatment Outcomes of Patients with Macrolide-Resistant Mycobacterium massiliense Lung Disease.

    PubMed

    Choi, Hayoung; Kim, Su-Young; Lee, Hyun; Jhun, Byung Woo; Park, Hye Yun; Jeon, Kyeongman; Kim, Dae Hun; Huh, Hee Jae; Ki, Chang-Seok; Lee, Nam Yong; Lee, Seung-Heon; Shin, Sung Jae; Daley, Charles L; Koh, Won-Jung

    2017-02-01

    Macrolide antibiotics are cornerstones in the treatment of Mycobacterium massiliense lung disease. Despite the emergence of resistance, limited data on macrolide-resistant M massiliense lung disease are available. This study evaluated the clinical features and treatment outcomes of patients and the molecular characteristics of macrolide-resistant M massiliense isolates. We performed a retrospective review of medical records and genetic analyses of clinical isolates from 15 patients who had macrolide-resistant M massiliense lung disease between September 2005 and February 2015. Nine patients (60%) had the nodular bronchiectatic form of the disease, and six (40%) had the fibrocavitary form. Before the detection of macrolide resistance, three patients (20%) were treated with macrolide monotherapy, four (27%) with therapy for presumed Mycobacterium avium complex infections, and eight (53%) with combination antibiotic therapy for M massiliense lung disease. The median treatment duration after the detection of resistance was 18.7 months (interquartile range, 11.2 to 39.8 months). Treatment outcomes were poor, with a favorable outcome being achieved for only one patient (7%), who underwent surgery in addition to antibiotic therapy. The 1-, 3-, and 5-year mortality rates were 7, 13, and 33%, respectively. Of the 15 clinical isolates, 14 (93%) had point mutations at position 2058 (n = 9) or 2059 (n = 5) of the 23S rRNA gene, resulting in macrolide resistance. Our study indicates that treatment outcomes are poor and mortality rates are high after the development of macrolide resistance in patients with M massiliense lung disease. Thus, preventing the development of macrolide resistance should be a key consideration during treatment.

  19. Likelihood of Being Helped or Harmed as a Measure of Clinical Outcomes in Psychopharmacology.

    PubMed

    Andrade, Chittaranjan

    2017-01-01

    The likelihood of being helped or harmed (LHH) ratio is an indirect measure of effect size. It tells the reader how much as likely a patient is to benefit from a treatment as to suffer from an adverse outcome with that treatment; larger values for LHH indicate more favorable treatment outcomes. The numerator for LHH is usually a measure of response or remission with a treatment, and the denominator is usually a measure of all-cause discontinuation or discontinuation due to adverse events; so, there can be more than 1 LHH statistic for a study. As an example, an LHH of 5 could indicate that after removal of placebo effects a patient is 5 times as likely to respond to a treatment as to drop out of treatment because of the experience of an adverse event. This article explains the LHH with the help of a worked example, shows how the LHH can be derived from the numbers needed to treat and harm (NNT, NNH) statistics, discusses practical issues related to the concept, and considers its limitations. The LHH is little used in clinical psychopharmacology, and authors who report or review clinical trial data should consider presenting all the LHH information that is clinically relevant in addition to NNT, NNH, and other information. Because LHH statistics present the results of risk-benefit trade-off analyses, they can help clinicians and patients more easily evaluate potential treatments during decision-making processes.

  20. A greater number of dissected lymph nodes is associated with more favorable outcomes in bladder cancer treated by radical cystectomy: a meta-analysis

    PubMed Central

    Lin, Fengsheng; Chen, Pengliang; Pang, Shiyu

    2016-01-01

    The optimal extent of lymph node dissection (LND) is currently not established, and the debate regarding the association between the number of dissected nodes and the outcomes of bladder cancer treated by radical cystectomy (RC) is still ongoing. Therefore, the present meta-analysis was performed to clarify this potential relationship. Eligible studies were retrieved via an electronic search for studies published up to April 2016, and by manual review of the references. A total of 25 cohort studies involving 41,400 bladder cancer patients who underwent RC were included. The summary relative risk estimates (SRRE) based on the highest compared with the lowest categories of LND were estimated by variance-based meta-analysis. Heterogeneity among the study results was explored through stratified analyses. Overall, bladder cancer patients with the highest category of LND had 28%, 34% and 36% reduced risks, corresponding to overall survival (SRRE = 0.72; 95% CI, 0.64–0.80), cancer-specific survival (SRRE = 0.66; 95% CI, 0.54–0.80) and recurrence-free survival (SRRE = 0.64; 95% CI, 0.50–0.82), respectively, compared with patients with the lowest category of LND. In summary, the patients with a greater number of dissected lymph nodes had statistically significant survival advantages in terms of the outcomes of bladder cancer following RC. The number of dissected lymph nodes could be an independent prognostic factor for bladder cancer. These findings need to be validated in prospective and larger epidemiological studies with a longer follow-up period. PMID:27542252

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

    PubMed

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

    2012-04-25

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

  2. Asymmetric Gray Matter Volume Changes Associated with Epilepsy Duration and Seizure Frequency in Temporal-Lobe-Epilepsy Patients with Favorable Surgical Outcome

    PubMed Central

    Kim, Jeong Sik; Koo, Dae Lim; Joo, Eun Yeon; Kim, Sung Tae; Seo, Dae Won

    2016-01-01

    Background and Purpose This study aimed to estimate the changes in gray matter volume (GMV) and their hemispheric difference in patients with mesial temporal lobe epilepsy (MTLE) using a voxel-based morphometry (VBM) methodology, and to determine whether GMV changes are correlated with clinical features. Methods VBM analysis of brain MRI using statistical parametric mapping 8 (SPM8) was performed for 30 left MTLE (LMTLE) and 30 right MTLE (RMTLE) patients and 30 age- and sex-matched healthy controls. We also analyzed the correlations between GMV changes and clinical features of MTLE patients. Results In SPM8-based analyses, MTLE patients showed significant GMV reductions in the hippocampus ipsilateral to the epileptic focus, bilateral thalamus, and contralateral putamen in LMTLE patients. The GMV reductions were more extensive in the ipsilateral hippocampus, thalamus, caudate, putamen, uncus, insula, inferior temporal gyrus, middle occipital gyrus, cerebellum, and paracentral lobule in RMTLE patients. These patients also exhibited notable reductions of GMV in the contralateral hippocampus, thalamus, caudate, putamen, and inferior frontal gyrus. We observed that GMV reduction was positively correlated with several clinical features (epilepsy duration and seizure frequency in RMTLE, and history of febrile seizure in LMTLE) and negatively correlated with seizure onset age in both the RMTLE and LMTLE groups. Conclusions Our study revealed GMV decreases in the hippocampus and extrahippocampal regions. Furthermore, the GMV reduction was more extensive in the RMTLE group than in the LMTLE group, since it included the contralateral hemisphere in the former. This difference in the GMV reduction patterns between LMTLE and RMTLE may be related to a longer epilepsy duration and higher seizure frequency in the latter. PMID:27449913

  3. 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

  4. The clinical outcomes of oldest old patients with tuberculosis treated by regimens containing rifampicin, isoniazid, and pyrazinamide

    PubMed Central

    Lin, Huang-Shen; Cheng, Chun-Wen; Lin, Ming-Shyan; Chou, Yen-Li; Chang, Pey-Jium; Lin, Jing-Chi; Ye, Jung-Jr

    2016-01-01

    Objectives To investigate the clinical characteristics, adverse drug reactions, and outcomes of the oldest old patients (aged ≥80 years) with tuberculosis (TB) treated with rifampicin, isoniazid, and pyrazinamide (RIP)-containing regimens. Design A retrospective chart review study. Setting A 1,200-bed tertiary teaching hospital in southwest Taiwan. Participants We conducted a retrospective observational study between January 1, 2005 and December 31, 2011. Seven hundred adult patients (aged ≥18 years) with TB treated with RIP-containing anti-TB regimens were reviewed, including 161 oldest old patients. Outcome measures Clinical outcomes included clinical responsiveness and microbiological eradication. Adverse outcomes included drug-induced hepatitis, and other symptoms included gastrointestinal upset (eg, abdominal pain, vomiting, diarrhea, or dyspepsia), skin rash, joint pain, and hyperuricemia. Results Compared with the non-oldest old adult patients, the oldest old patients more frequently had hepatitis (P=0.014), gastrointestinal upset (P=0.029), and unfavorable outcomes (P<0.001). In a multivariate analysis, hepatitis during treatment (adjusted odds ratio: 3.482, 95% confidence interval: 1.537–7.885; P<0.003) and oldest old age (adjusted odds ratio: 5.161, 95% confidence interval: 2.294–11.613; P<0.010) were independent risk factors for unfavorable outcomes. In the oldest old patients with hepatitis, rifampicin use was more common in the favorable outcome group than in the unfavorable outcome group (100% vs 37.5%; P=0.001). Conclusion The oldest old age and hepatitis during RIP treatment were associated with unfavorable outcomes. For the oldest old patients with TB having hepatitis during treatment, rifampicin rechallenge and use might benefit the treatment outcome. PMID:27042029

  5. 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

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

    PubMed Central

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

    2012-01-01

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

  7. Low ABCB1 and high OCT1 levels play a favorable role in the molecular response to imatinib in CML patients in the community clinical practice.

    PubMed

    da Cunha Vasconcelos, Flavia; Mauricio Scheiner, Marcos Antonio; Moellman-Coelho, Arthur; Mencalha, André Luiz; Renault, Ilana Zalcberg; Rumjanek, Vivian Mary; Maia, Raquel Ciuvalschi

    2016-12-01

    Despite the favorable clinical evolution of patients with chronic myeloid leukemia (CML), resistance or intolerance to imatinib is present in approximately 35% of patients. Sokal score is a widely used risk factor, however efflux and influx transporters are provisional risk factors implicated in imatinib resistance. This study analyzed Sokal score, ABCB1, ABCG2 and OCT1 mRNA transporter expression levels as well as P-glycoprotein expression and efflux transporters activity to seek a possible correlation between these factors and the molecular response at 12 months from imatinib start as well as 8-year overall survival (OS). Low plus intermediate Sokal score correlated to optimal imatinib responses, as well as OS at 8-years, thus confirming the established role of Sokal score as a prognostic factor in CML patients. Low ABCB1 and high OCT1 mRNA levels were associated with an optimal molecular response, while the inverse levels were associated with non-responders (warning and failure) patients. Our results suggest that ABCB1 and OCT1 mRNA expressions may present biological relevance to identify responder and non-responder patients to imatinib treatment.

  8. Hypofractionated Radiation Therapy (66 Gy in 22 Fractions at 3 Gy per Fraction) for Favorable-Risk Prostate Cancer: Long-term Outcomes

    SciTech Connect

    Patel, Nita; Faria, Sergio; Cury, Fabio; David, Marc; Duclos, Marie; Shenouda, George; Ruo, Russell; Souhami, Luis

    2013-07-01

    Purpose: To report long-term outcomes of low- and intermediate-risk prostate cancer patients treated with high-dose hypofractionated radiation therapy (HypoRT). Methods and Materials: Patients with low- and intermediate-risk prostate cancer were treated using 3-dimensional conformal radiation therapy to a dose of 66 Gy in 22 daily fractions of 3 Gy without hormonal therapy. A uniform 7-mm margin was created around the prostate for the planning target volume, and treatment was prescribed to the isocenter. Treatment was delivered using daily ultrasound image-guided radiation therapy. Common Terminology Criteria for Adverse Events, version 3.0, was used to prospectively score toxicity. Biochemical failure was defined as the nadir prostate-specific antigen level plus 2 ng/mL. Results: A total of 129 patients were treated between November 2002 and December 2005. With a median follow-up of 90 months, the 5- and 8-year actuarial biochemical control rates were 97% and 92%, respectively. The 5- and 8-year actuarial overall survival rates were 92% and 88%, respectively. Only 1 patient died from prostate cancer at 92 months after treatment, giving an 8-year actuarial cancer-specific survival of 98%. Radiation therapy was well tolerated, with 57% of patients not experiencing any acute gastrointestinal (GI) or genitourinary (GU) toxicity. For late toxicity, the worst grade ≥2 rate for GI and GU toxicity was 27% and 33%, respectively. There was no grade >3 toxicity. At last follow-up, the rate of grade ≥2 for both GI and GU toxicity was only 1.5%. Conclusions: Hypofractionation with 66 Gy in 22 fractions prescribed to the isocenter using 3-dimensional conformal radiation therapy produces excellent biochemical control rates, with moderate toxicity. However, this regimen cannot be extrapolated to the intensity modulated radiation therapy technique.

  9. The perception of the illness with subsequent outcome measure in more favorable in continuos peritoneal dialysis vs hemodialysis in the framework of appraisal model of stress.

    PubMed

    Nowak, Zbigniew; Laudański, Krzysztof

    2014-01-01

    The aim of the study was to use the appraisal model of stress to compare hemodialysis (HD) and continuous peritoneal dialysis (CAPD) patients with special focus on the perception of end-stage renal disease and subsequent emotional profile and health related quality of life (HQoL) in. We hypothesize that different circumstances related to both modes of therapies will result in dissimilar perception of chronic illness with subsequent changes in emotional profile and heath related quality of life. The total of 88 patients with end stage renal disease (ESRD) enrolled in hemodialysis (n=52; HD) or continuous peritoneal dialysis (n=36; CAPD) were given a battery of psychological tests: The Profile of Mood States, The Nottingham Health Profile, The Stress Situation Assessment Questionnaire, The Social Appreciation Questionnaire and The Situation and Trait and Anxiety Inventory. All patients perceived ESRD in terms of a loss and a threat. Moreover, CAPD patients evaluated ESRD as a challenge. Despite different perception of ESRD no significant difference in the level of fear, anxiety or emotional profile was found. Both HD and CAPD patient were reported more fatigue/inertia and confusion/bewilderment than control groups. The main health related complaints were similar in both ESRD patients with major complaints of sleeping disturbances, motor limitations and lack of energy. From the psychological point of view, CAPD treatment seems more like challenge to the enrolled patient which is positive outcome. Despite different appraisal of stress mood and health related complaints were similar in both groups. This may be a result of optimal regulation of cognitive perception of the stress depending on the circumstances of therapy.

  10. The perception of the Illness with Subsequent Outcome Measure in More Favorable in Continuos Peritoneal Dialysis vs Hemodialysis in the Framework of Appraisal Model of Stress

    PubMed Central

    Nowak, Zbigniew; Laudański, Krzysztof

    2014-01-01

    The aim of the study was to use the appraisal model of stress to compare hemodialysis (HD) and continuous peritoneal dialysis (CAPD) patients with special focus on the perception of end-stage renal disease and subsequent emotional profile and health related quality of life (HQoL) in. We hypothesize that different circumstances related to both modes of therapies will result in dissimilar perception of chronic illness with subsequent changes in emotional profile and heath related quality of life. The total of 88 patients with end stage renal disease (ESRD) enrolled in hemodialysis (n=52; HD) or continuous peritoneal dialysis (n=36; CAPD) were given a battery of psychological tests: The Profile of Mood States, The Nottingham Health Profile, The Stress Situation Assessment Questionnaire, The Social Appreciation Questionnaire and The Situation and Trait and Anxiety Inventory. All patients perceived ESRD in terms of a loss and a threat. Moreover, CAPD patients evaluated ESRD as a challenge. Despite different perception of ESRD no significant difference in the level of fear, anxiety or emotional profile was found. Both HD and CAPD patient were reported more fatigue/inertia and confusion/bewilderment than control groups. The main health related complaints were similar in both ESRD patients with major complaints of sleeping disturbances, motor limitations and lack of energy. From the psychological point of view, CAPD treatment seems more like challenge to the enrolled patient which is positive outcome. Despite different appraisal of stress mood and health related complaints were similar in both groups. This may be a result of optimal regulation of cognitive perception of the stress depending on the circumstances of therapy. PMID:24516354

  11. 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

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

    PubMed

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

    2012-08-01

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

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

    PubMed

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

    2012-04-01

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

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

    PubMed

    Linden, W

    1994-09-01

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

  15. 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

  16. Prognosis of metastatic breast cancer subtypes: the hormone receptor/HER2-positive subtype is associated with the most favorable outcome.

    PubMed

    Lobbezoo, Dorien J A; van Kampen, Roel J W; Voogd, Adri C; Dercksen, M Wouter; van den Berkmortel, Franchette; Smilde, Tineke J; van de Wouw, Agnes J; Peters, Frank P J; van Riel, Johanna M G H; Peters, Natascha A J B; de Boer, Maaike; Borm, George F; Tjan-Heijnen, Vivianne C G

    2013-10-01

    Contrary to the situation in early breast cancer, little is known about the prognostic relevance of the hormone receptor (HR) and human epidermal growth factor receptor 2 (HER2) in metastatic breast cancer. The objectives of this study were to present survival estimates and to determine the prognostic impact of breast cancer subtypes based on HR and HER2 status in a recent cohort of metastatic breast cancer patients, which is representative of current clinical practice. Patients diagnosed with metastatic breast cancer between 2007 and 2009 were included. Information regarding patient and tumor characteristics and treatment was collected. Patients were categorized in four subtypes based on the HR and HER2 status of the primary tumor: HR positive (+)/HER2 negative (-), HR+/HER2+, HR-/HER2+ and triple negative (TN). Survival was estimated using the Kaplan-Meier method. Cox proportional hazards model was used to determine the prognostic impact of breast cancer subtype, adjusted for possible confounders. Median follow-up was 21.8 months for the 815 metastatic breast cancer patients included; 66 % of patients had the HR+/HER2- subtype, 8 % the HR-/HER2+ subtype, 15 % the TN subtype and 11 % the HR+/HER2+ subtype. The longest survival was observed for the HR+/HER2+ subtype (median 34.4 months), compared to 24.8 months for the HR+/HER2- subtype, 19.8 months for the HR-/HER2+ subtype and 8.8 months for the TN subtype (P < 0.0001). In the multivariate analysis, subtype was an independent prognostic factor, as were initial site of metastases and metastatic-free interval. The HR+/HER2+ subtype was associated with the longest survival after diagnosis of distant metastases.

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

    PubMed

    Massof, Robert W

    2010-01-01

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

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

    PubMed

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

    2014-01-01

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

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

    PubMed

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

    2012-04-01

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

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

    PubMed

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

    2010-01-01

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

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

    PubMed Central

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

    2017-01-01

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

  2. Outcome Measures for Clinical Drug Trials in Autism

    PubMed Central

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

    2015-01-01

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

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

    PubMed

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

    2012-05-01

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

  5. 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.

  6. Clinical outcomes of subtotal cholecystectomy performed for difficult cholecystectomy

    PubMed Central

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

    2016-01-01

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

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

    PubMed Central

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

    2016-01-01

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

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

    PubMed

    McAllister, M; Dearing, A

    2015-08-01

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

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

    PubMed

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

    1995-09-01

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

  10. 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

  11. 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

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

    PubMed Central

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

    2017-01-01

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

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

    PubMed

    Benedetti, Fabrizio; Dogue, Sara

    2015-01-01

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

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

    PubMed Central

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

    2012-01-01

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

  15. Predictors of survival and favorable functional outcomes after an out-of-hospital cardiac arrest in patients systematically brought to a dedicated heart attack center (from the Harefield Cardiac Arrest Study).

    PubMed

    Iqbal, M Bilal; Al-Hussaini, Abtehale; Rosser, Gareth; Salehi, Saleem; Phylactou, Maria; Rajakulasingham, Ramyah; Patel, Jayna; Elliott, Katharine; Mohan, Poornima; Green, Rebecca; Whitbread, Mark; Smith, Robert; Ilsley, Charles

    2015-03-15

    Despite advances in cardiopulmonary resuscitation (CPR), survival remains low after out-of-hospital cardiac arrest (OOHCA). Acute coronary ischemia is the predominating precipitant, and prompt delivery of patients to dedicated facilities may improve outcomes. Since 2011, all patients experiencing OOHCA in London, where a cardiac etiology is suspected, are systematically brought to heart attack centers (HACs). We determined the predictors for survival and favorable functional outcomes in this setting. We analyzed 174 consecutive patients experiencing OOHCA from 2011 to 2013 brought to Harefield Hospital-a designated HAC in London. We analyzed (1) all-cause mortality and (2) functional status using a modified Rankin scale (mRS 0 to 6, where mRS0-3(+) = favorable functional status). The overall survival rates were 66.7% (30 days) and 62.1% (1 year); and 54.5% had mRS0-3(+) at discharge. Patients with mRS0-3(+) had reduced mortality compared to mRS0-3(-): 30 days (1.2% vs 72.2%, p <0.001) and 1 year (5.3% vs 77.2%, p <0.001). Multivariate analyses identified lower patient comorbidity, absence of cardiogenic shock, bystander CPR, ventricular tachycardia/ventricullar fibrillation as initial rhythm, shorter duration of resuscitation, prehospital advanced airway, absence of adrenaline and inotrope use, and intra-aortic balloon pump use as predictors of mRS0-3(+). Consistent predictors of increased mortality were the presence of cardiogenic shock, advanced airway use, increased duration of resuscitation, and absence of therapeutic hypothermia. A streamlined delivery of patients experiencing OOHCA to dedicated facilities is associated with improved functional status and survival. Our study supports the standardization of care for such patients with the widespread adoption of HACs.

  16. Clinical outcome of surgical periodontal therapy: a short-term retrospective study.

    PubMed

    Hayakawa, Hiroki; Fujinami, Koushu; Ida, Atsushi; Furusawa, Masahiro; Nikaido, Masahiko; Yamashita, Shuichiro; Saito, Atsushi

    2012-01-01

    This study aimed to investigate retrospectively the outcome of surgical periodontal therapy. Periodontal surgeries implemented at General Dentistry, Tokyo Dental College Suidobashi Hospital during the period of April 2010 through March 2012 were subjected to data analysis. After initial periodontal therapy, 17 clinicians performed a total of 138 periodontal surgeries in 80 patients with moderate to advanced periodontitis (31 men and 49 women; mean age 54). Cases (sites) operated were as follows: open flap debridement=102, periodontal regenerative therapy=29 (17 for intrabony defects, 12 for furcation involvements) and periodontal plastic surgery=7. Enamel matrix derivative or bone graft was used for regenerative therapy. Clinical data were analyzed focusing on the comparison between open flap debridement and regenerative therapy. At 5 months after open flap debridement, mean reduction in probing depth (PD) and gain in clinical attachment level (CAL) was 3.9 mm (range -1.0-9.0) and 2.3 mm (range -1.0-9.0), respectively. The corresponding values with regenerative therapy were 4.0 mm (range 0-8.0) and 2.8 mm (-1.0-6.0), respectively. At sites with initial PD≥8 mm, a significantly greater gain in CAL was obtained with the regenerative therapy than with flap surgery (mean CAL gain 4.3 mm vs. 2.9 mm, p<0.05). Periodontal surgery performed in our clinical setting demonstrated a favorable short-term outcome. Our data suggest the efficacy of regenerative therapy, in particular for the treatment of deep pockets.

  17. Analysis of current therapy and clinical outcome in childhood pemphigus vulgaris.

    PubMed

    Mabrouk, Dalia; Ahmed, A Razzaque

    2011-01-01

    Pemphigus vulgaris (PV) is a rare, potentially fatal chronic autoimmune disease of the skin and mucous membrane. The objective of this study was to analyze the clinical outcomes and side effects associated with treatment of childhood PV (CPV). A retrospective review of the English language literature was conducted through PUBMED using the words childhood pemphigus vulgaris, and treatment or clinical outcome. Only patients under 12 years of age were included. Thirty-three cases were found in 29 reports. Mean age at onset was 8.3 years (range 1.5-12 yrs). Mucosal involvement (97.0%) was more common than cutaneous involvement (84.8%). Oral mucosa was the most common site of mucosal involvement (93.9%), followed by genital (20.6%), ocular (11.8%), and nasal mucosa (2.9%). Mean duration of therapy was 4.5 years (range 0.6-14.5 yrs), and mean duration of follow-up was 5.2 years (range 0.6-16 yrs). Complete recovery with no further therapy was achieved in 18.2% and partial recovery with minor relapses while on maintenance therapy in 78.8%. One patient died due to infection (3.0%). Serious side effects were present in 60.6%. The most common were cushingoid features (65.0%), growth retardation (50.0%), and infection (50.0%). Two patients who were refractory to systemic corticosteroids and immunosuppressive agents (ISA) had a favorable clinical response to Rituximab. Current therapy for CPV involving the use of long-term systemic corticosteroids in conjunction with ISA results in prolonged immunosuppression, causing systemic infections and growth retardation. Safer and more effective therapies need to be explored.

  18. 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.

  19. 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

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

    PubMed

    Olupot-Olupot, Peter

    2015-03-01

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

  1. Cytogenetic abnormalities and monosomal karyotypes in children and adolescents with acute myeloid leukemia: correlations with clinical characteristics and outcome.

    PubMed

    Manola, Kalliopi N; Panitsas, Fotios; Polychronopoulou, Sophia; Daraki, Aggeliki; Karakosta, Maria; Stavropoulou, Cryssa; Avgerinou, Georgia; Hatzipantelis, Emmanuel; Pantelias, Gabriel; Sambani, Constantina; Pagoni, Maria

    2013-03-01

    The whole spectrum of chromosomal abnormalities and their prognostic significance in children and adolescents with acute myeloid leukemia (AML) has not been fully elucidated yet, although a considerable amount of knowledge has been gained recently. Moreover, the incidence and prognostic impact of monosomal karyotypes (MKs), which are new cytogenetic categories reported recently in adults with AML, are currently unknown for childhood and adolescent AML. In this study, we investigated the cytogenetic and clinical characteristics of 140 children and adolescents (≤21 y) with AML, and correlated their cytogenetic features with both the clinical characteristics and outcomes of our patient cohort. The most frequent cytogenetic abnormality found in our study was the t(15;17), followed by the t(8;21). Striking differences in the genetic abnormalities and French-American-British subtypes were found among infants, children, and adolescents. Of 124 cases, 15 (12.1%) met the criteria of the MK definition, and 12 of the 15 MKs (80%) were complex karyotypes. Of 124 cases, 27 (21.8%) had cytogenetic abnormalities sufficient to be diagnosed as AML with myelodyspastic sydrome-related features. As expected, patients with the t(15;17) had the most favorable outcomes, whereas patients with 11q23 rearrangements and monosomy 7 had the worst outcomes. These data expand our knowledge by providing novel insights into the cytogenetic features and their correlations with clinical characteristics and outcomes in childhood and adolescent AML.

  2. 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

  3. 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

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

    PubMed

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

    2009-11-16

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

  5. Proton Radiotherapy for Childhood Ependymoma: Initial Clinical Outcomes and Dose Comparisons

    SciTech Connect

    MacDonald, Shannon M. Safai, Sairos; Trofimov, Alexei; Wolfgang, John; Fullerton, Barbara; Yeap, Beow Y.; Bortfeld, Thomas; Tarbell, Nancy J.; Yock, Torunn

    2008-07-15

    Purpose: To report preliminary clinical outcomes for pediatric patients treated with proton beam radiation for intracranial ependymoma and compare the dose distributions of intensity-modulated radiation therapy with photons (IMRT), three-dimensional conformal proton radiation, and intensity-modulated proton radiation therapy (IMPT) for representative patients. Methods and Materials: All children with intracranial ependymoma confined to the supratentorial or infratentorial brain treated at the Francis H. Burr Proton Facility and Harvard Cyclotron between November 2000 and March 2006 were included in this study. Seventeen patients were treated with protons. Proton, IMRT, and IMPT plans were generated with similar clinical constraints for representative infratentorial and supratentorial ependymoma cases. Tumor and normal tissue dose-volume histograms were calculated and compared. Results: At a median follow-up of 26 months from the start date of radiation therapy, local control, progression-free survival, and overall survival rates were 86%, 80%, and 89%, respectively. Subtotal resection was significantly associated with decreased local control (p = 0.016). Similar tumor volume coverage was achieved with IMPT, proton therapy, and IMRT. Substantial normal tissue sparing was seen with proton therapy compared with IMRT. Use of IMPT will allow for additional sparing of some critical structures. Conclusions: Preliminary disease control with proton therapy compares favorably with the literature. Dosimetric comparisons show the advantage of proton radiation compared with IMRT in the treatment of ependymoma. Further sparing of normal structures appears possible with IMPT. Superior dose distributions were accomplished with fewer beam angles with the use of protons and IMPT.

  6. Clinical Outcomes of Enterobacteriaceae Infections Stratified by Carbapenem MICs

    PubMed Central

    Patel, Twisha S.

    2014-01-01

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

  7. 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

  8. 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

  9. Clinical outcomes of gastric polyps and neoplasms in patients with familial adenomatous polyposis

    PubMed Central

    Nakamura, Keiko; Nonaka, Satoru; Nakajima, Takeshi; Yachida, Tatsuo; Abe, Seiichiro; Sakamoto, Taku; Suzuki, Haruhisa; Yoshinaga, Shigetaka; Oda, Ichiro; Matsuda, Takahisa; Sekine, Shigeki; Kanemitsu, Yukihide; Katai, Hitoshi; Saito, Yutaka; Hirota, Seiichi

    2017-01-01

    Background and study aims Familial adenomatous polyposis (FAP) is an autosomal dominant syndrome caused by a germline mutation in the adenomatous polyposis coli (APC) gene, characterized by the presence of more than 100 adenomatous polyps in the colorectum. The upper gastrointestinal tract is an extracolonic site for malignancy in patients with FAP. The frequency of death in Japanese patients with FAP because of gastric cancer is 2.8 % and that because of colon cancer is 60.6 %. Few studies have reported upper gastrointestinal diseases in patients with FAP. In the present study, we investigated the clinical outcomes of patients with FAP diagnosed with gastric neoplasms. Patients and methods We enrolled 80 patients with FAP who underwent esophagogastroduodenoscopy from October 1997 to December 2011. We investigated patient characteristics, endoscopic findings of gastric lesions, treatment outcomes, and long-term courses. Results Fundic gland polyposis was observed in 51 patients (64 %) and gastric neoplasms in 22 patients (28 %), including 20 with non-invasive and 2 with invasive neoplasm. Of the 26 neoplasms, 11 were treated by endoscopic resection (ER) and 4 by surgical resection. Metachronous gastric neoplasms were observed in 7 patients (15 lesions) and treated by ER, except for in 1 patient. No patients died of gastric lesions during a median follow-up period of 6.5 years (range, 0 – 14). Conclusion Because gastric lesions including gastric cancers in patients with FAP did not cause any deaths, they can be considered to have favorable prognoses. Early detection of gastric neoplasms through an appropriate follow-up interval may have contributed to these good outcomes. PMID:28271094

  10. Clinical outcomes of gastric polyps and neoplasms in patients with familial adenomatous polyposis.

    PubMed

    Nakamura, Keiko; Nonaka, Satoru; Nakajima, Takeshi; Yachida, Tatsuo; Abe, Seiichiro; Sakamoto, Taku; Suzuki, Haruhisa; Yoshinaga, Shigetaka; Oda, Ichiro; Matsuda, Takahisa; Sekine, Shigeki; Kanemitsu, Yukihide; Katai, Hitoshi; Saito, Yutaka; Hirota, Seiichi

    2017-03-01

    Background and study aims Familial adenomatous polyposis (FAP) is an autosomal dominant syndrome caused by a germline mutation in the adenomatous polyposis coli (APC) gene, characterized by the presence of more than 100 adenomatous polyps in the colorectum. The upper gastrointestinal tract is an extracolonic site for malignancy in patients with FAP. The frequency of death in Japanese patients with FAP because of gastric cancer is 2.8 % and that because of colon cancer is 60.6 %. Few studies have reported upper gastrointestinal diseases in patients with FAP. In the present study, we investigated the clinical outcomes of patients with FAP diagnosed with gastric neoplasms. Patients and methods We enrolled 80 patients with FAP who underwent esophagogastroduodenoscopy from October 1997 to December 2011. We investigated patient characteristics, endoscopic findings of gastric lesions, treatment outcomes, and long-term courses. Results Fundic gland polyposis was observed in 51 patients (64 %) and gastric neoplasms in 22 patients (28 %), including 20 with non-invasive and 2 with invasive neoplasm. Of the 26 neoplasms, 11 were treated by endoscopic resection (ER) and 4 by surgical resection. Metachronous gastric neoplasms were observed in 7 patients (15 lesions) and treated by ER, except for in 1 patient. No patients died of gastric lesions during a median follow-up period of 6.5 years (range, 0 - 14). Conclusion Because gastric lesions including gastric cancers in patients with FAP did not cause any deaths, they can be considered to have favorable prognoses. Early detection of gastric neoplasms through an appropriate follow-up interval may have contributed to these good outcomes.

  11. Immune thrombocytopenia in adults: a prospective cohort study of clinical features and predictors of outcome

    PubMed Central

    Grimaldi-Bensouda, Lamiae; Nordon, Clémentine; Michel, Marc; Viallard, Jean-François; Adoue, Daniel; Magy-Bertrand, Nadine; Durand, Jean-Marc; Quittet, Philippe; Fain, Olivier; Bonnotte, Bernard; Morin, Anne-Sophie; Morel, Nathalie; Costedoat-Chalumeau, Nathalie; Pan-Petesch, Brigitte; Khellaf, Mehdi; Perlat, Antoinette; Sacre, Karim; Lefrere, François; Abenhaim, Lucien; Godeau, Bertrand

    2016-01-01

    This prospective observational cohort study aimed to explore the clinical features of incident immune thrombocytopenia in adults and predictors of outcome, while determining if a family history of autoimmune disorder is a risk factor for immune thrombocytopenia. All adults, 18 years of age or older, recently diagnosed with immune thrombocytopenia were consecutively recruited across 21 hospital centers in France. Data were collected at diagnosis and after 12 months. Predictors of chronicity at 12 months were explored using logistic regression models. The association between family history of autoimmune disorder and the risk of developing immune thrombocytopenia was explored using a conditional logistic regression model after matching each case to 10 controls. One hundred and forty-three patients were included: 63% female, mean age 48 years old (Standard Deviation=19), and 84% presented with bleeding symptoms. Median platelet count was 10×109/L. Initial treatment was required in 82% of patients. After 12 months, only 37% of patients not subject to disease-modifying interventions achieved cure. The sole possible predictor of chronicity at 12 months was a higher platelet count at baseline [Odds Ratio 1.03; 95%CI: 1.00, 1.06]. No association was found between outcome and any of the following features: age, sex, presence of either bleeding symptoms or antinuclear antibodies at diagnosis. Likewise, family history of autoimmune disorder was not associated with incident immune thrombocytopenia. Immune thrombocytopenia in adults has been shown to progress to a chronic form in the majority of patients. A lower platelet count could be indicative of a more favorable outcome. PMID:27229715

  12. 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.

  13. Systematic review of clinical outcomes after prophylactic surgery

    PubMed Central

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

    2016-01-01

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

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

    PubMed

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

    2015-07-15

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

  15. Clinical outcomes and the mutation spectrum of the OTC gene in patients with ornithine transcarbamylase deficiency.

    PubMed

    Choi, Jin-Ho; Lee, Beom Hee; Kim, Ja Hye; Kim, Gu-Hwan; Kim, Yoo-Mi; Cho, Jahyang; Cheon, Chong-Kun; Ko, Jung Min; Lee, Jung Hyun; Yoo, Han-Wook

    2015-09-01

    Ornithine transcarbamylase (OTC) deficiency is an X-linked inborn error of the urea cycle that leads to the accumulation of ammonia, resulting in neurological deficits. This study was performed to describe the clinical outcomes, biochemical features and molecular spectra of patients with OTC deficiency. A total of 49 patients from 47 unrelated Korean pedigrees were included who were diagnosed with OTC deficiency based on biochemical findings and molecular analyses. Patient clinical features,biochemical findings and molecular data were analyzed retrospectively. Males with neonatal-onset phenotype presented with seizure or altered mentality (n=20). Biochemical findings showed high blood ammonia (1132.5±851.6 μmol l (− 1)) and urineorotic acid (1840.7±1731.3 mmol mol(− 1) Cr) levels. There were also five males with late-onset disease who presented with vomiting, irritability and seizure at age 8.2±9.4 years old (range, 0.6–20 years). Symptomatic females presented with vomiting,seizure, and altered mentality at age 3.5±3.5 years (range, 0.2–12.8 years; n=24). More males with the late-onset form and symptomatic females displayed mild hyperammonemia and orotic aciduria compared with those showing a neonatal phenotype (P<0.05). Molecular analysis identified 37 different mutations (22 missense, 5 large deletions, 4 small deletions, 1 insertion,3 nonsense and 2 splice sites) from all 49 patients; the mutations were dispersed throughout all coding exons. In Korean patients with OTC deficiency, mutations in OTC are genetically heterogeneous. Male patients with the neonatal-onset phenotype showed poor outcomes because of severe hyperammonemia. Early diagnosis and interventions for hyperammonemia can provide more favorable prognosis.

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

    PubMed Central

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

    1998-01-01

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

  17. 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.

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

    PubMed

    Stetter, Friedhelm; Kupper, Sirko

    2002-03-01

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

  19. Raised cerebrospinal fluid BAFF and APRIL levels in anti-N-methyl-d-aspartate receptor encephalitis: Correlation with clinical outcome.

    PubMed

    Deng, Bo; Liu, Xiao-Ni; Li, Xiang; Zhang, Xiang; Quan, Chao; Chen, Xiang-Jun

    2017-04-15

    In this study, we aimed to assess the levels of B cell activating factor from the tumor necrosis factor family (BAFF) and a proliferation-inducing ligand (APRIL) in cerebrospinal fluid (CSF) of patients with anti-N-methyl-d-aspartate receptor (NMDAR) encephalitis and determine their correlation with clinical outcome. BAFF and APRIL concentrations in CSF and serum from 40 patients with anti-NMDAR encephalitis and 20 controls were measured by enzyme-linked immunosorbent assay (ELISA). Compared with controls, the levels of both BAFF and APRIL in CSF were significantly increased in patients with anti-NMDAR encephalitis (p<0.001 and p<0.001). Patients with unfavorable outcome had higher levels of BAFF and APRIL in CSF than those who had favorable outcome (p<0.05 and p<0.05). BAFF and APRIL levels in CSF were elevated and associated with clinical outcome in patients with anti-NMDAR encephalitis, indicating that they may be valuable biomarkers to this disease.

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

    PubMed Central

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

    2016-01-01

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

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

    PubMed

    Chalmers, Robert J G

    2015-01-01

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

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

    PubMed

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

    2012-12-01

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

  3. 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

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

    PubMed Central

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

    2012-01-01

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

  5. 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...

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

    PubMed

    Choy, Ernest H; Mease, Philip J

    2009-05-01

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

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

    PubMed

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

    2013-02-01

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

  8. The cost of implementing the Dialysis Outcomes Quality Initiative Clinical Practice Guidelines.

    PubMed

    Wish, J; Roberts, J; Besarab, A; Owen, W F

    1999-01-01

    For a clinical practice guideline to be accepted by the end-user, the system of reimbursement for the targeted service must be favorable. The National Kidney Foundation-Dialysis Outcomes Quality Initiative (NKF-DOQI) Guideline recommendations were developed without primary concern for the costs of their execution. Arguably, an unfavorable financial environment and excessive mercantile behavior by providers and payers would offer a considerable hindrance to their implementation. Toward addressing these concerns, three leaders in the development of the DOQI Guidelines for the Treatment of Anemia of Chronic Renal Failure, Hemodialysis Adequacy, and Vascular Access, have evaluated the hypothesis that implementing the recommendations of the DOQI Guidelines will increase the treatment costs for dialysis providers but will effect savings in the entire end-stage renal disease (ESRD) program. Their analyses suggest that under the current reimbursement system, this assumption may be true. However, restructured global reimbursement in the ESRD program will permit financial incentives for dialysis providers and the payer to coincide.

  9. Early Clinical Outcomes Using Proton Radiation for Children With Central Nervous System Atypical Teratoid Rhabdoid Tumors

    SciTech Connect

    De Amorim Bernstein, Karen; Sethi, Roshan; Trofimov, Alexei; Zeng, Chuan; Fullerton, Barbara; Yeap, Beow Y.; Ebb, David; Tarbell, Nancy J.; Yock, Torunn I.; MacDonald, Shannon M.

    2013-05-01

    Purpose: Atypical teratoid/rhabdoid tumor (AT/RT) is an uncommon and aggressive tumor that often affects infants. Irradiation improves survival but has traditionally been avoided in patients under the age of 3 due to the increasing risk of neurocognitive side effects. We report the first cohort of AT/RT patients treated with proton therapy. Methods and Materials: All patients with AT/RT treated at Massachusetts General Hospital (MGH) Frances H. Burr Proton Beam Therapy Benter between July 2004 and November 2011 were included in this study. All patients were treated with 3-dimensional conformal proton therapy (3D-CPT). Results: Ten consecutive patients of a median 2.3 years of age and with a median follow-up of 27.3 months (range, 11.3-99.4 months) were identified. Two patients suffered distant relapse; 1 patient was successfully treated with involved field irradiation and chemotherapy, while the second patient died of disease. At last follow-up, 9 patients were alive without evidence of disease. Proton radiation demonstrated increasing sparing of the cerebrum, temporal lobe, cochlea, and hypothalamus. Conclusions: Initial clinical outcomes with proton therapy are favorable. The advantages of proton therapy are particularly suited to the treatment of AT/RT, a tumor that often requires irradiation treatment at an age when avoiding irradiation to healthy tissues is most desirable.

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

    PubMed

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

    2015-02-01

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

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

    PubMed

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

    2012-01-01

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

  12. Does microgranular variant morphology of acute promyelocytic leukemia independently predict a less favorable outcome compared with classical M3 APL? A joint study of the North American Intergroup and the PETHEMA Group

    PubMed Central

    Kim, Haesook T.; Montesinos, Pau; Appelbaum, Frederick R.; de la Serna, Javier; Bennett, John M.; Deben, Guillermo; Bloomfield, Clara D.; Gonzalez, Jose; Feusner, James H.; Gonzalez, Marcos; Gallagher, Robert; Miguel, Jose D. Gonzalez-San; Larson, Richard A.; Milone, Gustavo; Paietta, Elisabeth; Rayon, Chelo; Rowe, Jacob M.; Rivas, Concha; Schiffer, Charles A.; Vellenga, Edo; Shepherd, Lois; Slack, James L.; Wiernik, Peter H.; Willman, Cheryl L.; Sanz, Miguel A.

    2010-01-01

    Few studies have examined the outcome of large numbers of patients with the microgranular variant (M3V) of acute promyelocytic leukemia (APL) in the all-trans retinoic acid era. Here, the outcome of 155 patients treated with all-trans retinoic acid–based therapy on 3 clinical trials, North American Intergroup protocol I0129 and Programa para el Estudio de la Terapéutica en Hemopatía Maligna protocols LPA96 and LPA99, are reported. The complete remission rate for all 155 patients was 82%, compared with 89% for 748 patients with classical M3 disease. The incidence of the APL differentiation syndrome was 26%, compared with 25% for classical M3 patients, and the early death rate was 13.6% compared with 8.4% for patients with classical M3 morphology. With a median follow-up time among survivors of 7.6 years (range 3.6-14.5), the 5-year overall survival, disease-free survival, and cumulative incidence of relapse for patients with M3V were 70%, 73%, and 24%, respectively. With a median follow-up time among survivors of 7.6 years (range 0.6-14.3), the 5-year overall survival, disease-free survival, and cumulative incidence of relapse among patients with classical M3 morphology were 80% (P = .006 compared with M3V), 81% (P = .07), and 15% (P = .005), respectively. When outcomes were adjusted for the white blood cell count or the relapse risk score, none of these outcomes were significantly different between patients with M3V and classical M3 APL. PMID:20858857

  13. Clinical Outcomes of Intensity-Modulated Pelvic Radiation Therapy for Carcinoma of the Cervix

    SciTech Connect

    Hasselle, Michael D.; Rose, Brent S.; Kochanski, Joel D.; Nath, Sameer K.; Bafana, Rounak; Yashar, Catheryn M.; Hasan, Yasmin; Roeske, John C.; Mundt, Arno J.; Mell, Loren K.

    2011-08-01

    Purpose: To evaluate disease outcomes and toxicity in cervical cancer patients treated with pelvic intensity-modulated radiation therapy (IMRT). Methods and Materials: We included all patients with Stage I-IVA cervical carcinoma treated with IMRT at three different institutions from 2000-2007. Patients treated with extended field or conventional techniques were excluded. Intensity-modulated radiation therapy plans were designed to deliver 45 Gy in 1.8-Gy daily fractions to the planning target volume while minimizing dose to the bowel, bladder, and rectum. Toxicity was graded according to the Radiation Therapy Oncology Group system. Overall survival and disease-free survival were estimated by use of the Kaplan-Meier method. Pelvic failure, distant failure, and late toxicity were estimated by use of cumulative incidence functions. Results: The study included 111 patients. Of these, 22 were treated with postoperative IMRT, 8 with IMRT followed by intracavitary brachytherapy and adjuvant hysterectomy, and 81 with IMRT followed by planned intracavitary brachytherapy. Of the patients, 63 had Stage I-IIA disease and 48 had Stage IIB-IVA disease. The median follow-up time was 27 months. The 3-year overall survival rate and the disease-free survival rate were 78% (95% confidence interval [CI], 68-88%) and 69% (95% CI, 59-81%), respectively. The 3-year pelvic failure rate and the distant failure rate were 14% (95% CI, 6-22%) and 17% (95% CI, 8-25%), respectively. Estimates of acute and late Grade 3 toxicity or higher were 2% (95% CI, 0-7%) and 7% (95% CI, 2-13%), respectively. Conclusions: Intensity-modulated radiation therapy is associated with low toxicity and favorable outcomes, supporting its safety and efficacy for cervical cancer. Prospective clinical trials are needed to evaluate the comparative efficacy of IMRT vs. conventional techniques.

  14. 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.

  15. 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

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

    PubMed

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

    2016-05-31

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

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

    PubMed

    Mares, Alvin S; Rosenheck, Robert A

    2007-02-01

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

  18. A Polycomb-mir200 loop regulates clinical outcome in bladder cancer

    PubMed Central

    Feber, Andrew; Segovia, Cristina; García-Escudero, Ramón; Rubio, Carolina; López-Calderón, Fernando F.; Díaz-García, Claudio; Villacampa, Felipe; Duarte, José; Gómez-Rodriguez, María J.; Castellano, Daniel; Rodriguez-Peralto, José L.; de la Rosa, Federico; Beck, Stephan; Paramio, Jesús M.

    2015-01-01

    Bladder cancer (BC) is a highly prevalent disease, ranking fifth in the most common cancers worldwide. Various miRNAs have recently emerged as potential prognostic biomarkers in cancer. The miR-200 family, which repressed the epithelial-to-mesenchymal transition (EMT), is repressed in multiple advanced cancers. However, its expression and function in BC is still poorly understood. Here we show that miR-200 family displays increased expression, probably due to the activation of specific oncogenic signaling pathways, and reduced promoter methylation, in BC compared to normal bladder samples. Furthermore, we show that the expression of these miRNAs is decreased in high grade and stage tumors, and the down-regulation is associated with patient's poor clinical outcome. Our data indicate that the miR-200 family plays distinct roles in Non-Muscle (NMIBC) and Muscle-Invasive BC (MIBC). In MIBC, miR-200 expression post transcriptionally regulates EMT-promoting transcription factors ZEB1 and ZEB2, whereas suppresses BMI1 expression in NMIBC. Interestingly, we show that increased EZH2 and/or BMI1 expression repress the expression of miR-200 family members. Collectively, these findings support a model of BC progression through a coordinated action between the Polycomb Repression Complex (PRC) members repressing the miR-200 expression, which ultimately favors invasive BC development. Since pharmacological inhibition of EZH2 in BC cell lines lead to increased miR-200 expression, our findings may support new therapeutic strategies for BC clinical management. PMID:26517683

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

    PubMed Central

    Calfee, Ryan P.; Adams, Amelia A.

    2012-01-01

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

  20. Functional and Clinical Outcomes of Upper Extremity Amputation.

    PubMed

    Fitzgibbons, Peter; Medvedev, Gleb

    2015-12-01

    Upper extremity amputation is an uncommon but often necessary procedure. It can be required as a result of trauma, infection, or malignancy. Amputation is a life-changing procedure. Careful planning for it must not only include the level of amputation and assurance of durable soft-tissue coverage of the amputation site, but it must also consider patients' goals and occupations, as well as social factors affecting amputees. The choice of prosthesis is an individual matter, but new technology permits lighter and more multifunctional prostheses. Targeted muscle reinnervation can be used to achieve improved myoelectric signaling and possibly decrease limb pain following amputation. Rehabilitation is crucial to achieving favorable results.

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

    PubMed

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

    2015-02-01

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

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

    PubMed Central

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

    2017-01-01

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

  3. Neuroprotective and consequent neurorehabilitative clinical outcomes, in patients treated with the pleiotropic drug cerebrolysin

    PubMed Central

    Mureşanu, DF; Ciurea, AV; Chendreanu, CD; Mihaescu, AS; Mardare, DC; Andone, I; SpȦnu, A; Popescu, C; Dumitrescu, A; Popescu, M; Grigorean, V; Ungur, B; Marinescu, F; Colibaşeanu, I; Onose, L; Haras, M; Sandu, A; Spircu, T

    2009-01-01

    Background: Discovery of neurotrophic factors–emblematic: the nerve growth factor (NGF)–resulted in better approaching central nervous system (CNS) lesions. Recently, another crucial property has been unveiled: their rather unique pleiotropic effect. Cerebrolysin is a peptide mixture that penetrates the blood–brain barrier in significant amounts and mimics the effects of NGF. Methods: Comparative analysis: Cerebrolysin treated (10 ml x 2/ day, i.v. x 3 weeks) vs. non–treated, in patients (all received aside, a rather equivalent complementary, pharmacological and physical, therapy). Two lots of patients, admitted in our Physical and Rehabilitation (neural–muscular) Medical–PR(n–m)M–Clinic Division, during 2007–2009: 69 treated with Cerebrolysin (22 F, 47 M; Average: 59.333; Mean of age: 61.0 Years old; Standard deviation 16.583) and 70 controls (41 F, 29 M; A: 70.014; M.o.a.: 70.5 Y.o.; S.d.: 6.270) were studied. The total number of assessed items was 13: most contributive in relation with the score of Functional Independence Measure at discharge (d FIM), were: admission (a FIM), number of physical therapy days (PT), number of hospitalization days (H), age (A) and–relatively–days until the first knee functional extension (KE). Concomitantly, the main/ key, focused on neuro–motor rehabilitative outcomes, functional/analytical parameters, have been assessed regarding the speed in achieving their functional recovery. Results: Concerning d FIM, there have not been objectified significant differences between the two lots (p=0.2453) but regarding key, focused on neuro–motor rehabilitative outcomes, functional/analytical parameters: KE (p=0.0007) and days until the first time recovery of the ability to walk between parallel bars (WPB–p=0.0000)–highly significant differences in favor of Cerebrolysin lot resulted. Conclusion: Cerebrolysin administration, as neurorehabilitative outcomes, proved to hasten, statistically significant, especially the

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

    ERIC Educational Resources Information Center

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

    1995-01-01

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

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

    PubMed Central

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

    2012-01-01

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

  6. 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.

  7. Invasion Patterns of Metastatic Extrauterine High-grade Serous Carcinoma With BRCA Germline Mutation and Correlation With Clinical Outcomes.

    PubMed

    Hussein, Yaser R; Ducie, Jennifer A; Arnold, Angela G; Kauff, Noah D; Vargas-Alvarez, Hebert A; Sala, Evis; Levine, Douglas A; Soslow, Robert A

    2016-03-01

    Characteristic histopathologic features have been described in high-grade serous carcinoma associated with BRCA abnormalities (HGSC-BRCA), which are known to have relatively favorable clinical outcomes. The aim of this study was to evaluate the clinical significance of invasion patterns in metastatic HGSC-BRCA cases. Of the 37 cases of advanced-stage HGSC with known BRCA1 or BRCA2 germline mutation retrieved from our institutional files, 23 patients had a germline mutation of BRCA1 and 14 had a BRCA2 mutation. The pattern of invasion at metastatic sites was recorded and classified as a pushing pattern (either predominantly or exclusively), an exclusively micropapillary infiltrative pattern, or an infiltrative pattern composed of papillae, micropapillae, glands, and nests (mixed infiltrative pattern). Histologic evaluation of metastases was performed without knowledge of genotype or clinical outcome. Clinical data were abstracted from medical records. Median age was 56 years (range, 31 to 73 y). All patients presented at stage IIIC or IV and underwent complete surgical staging followed by chemotherapy. All 37 HGSC-BRCA cases showed either pushing pattern metastases (30; 81%) or infiltrative micropapillary metastases (7; 19%). No HGSC-BRCA case exhibited metastases composed solely of mixed infiltrative patterns. Among the 7 infiltrative micropapillary cases, 6 had a BRCA1 germline mutation versus 1 with a BRCA2 mutation. The median time of follow-up was 26 months (range, 13 to 49 mo). All 7 patients with infiltrative micropapillary metastases either experienced recurrence or died of disease (5 recurrences and 2 deaths), which was significantly worse than what was seen in patients with predominantly pushing pattern metastases, of whom 16 of 30 (53%) experienced recurrence (n=14) or died of disease (n=2) (P=0.03). In conclusion, the recognition of different invasion patterns of metastatic extrauterine HGSC-BRCA has prognostic implications. The infiltrative

  8. Clinical outcomes of two main variants of progressive supranuclear palsy and multiple system atrophy: a prospective natural history study.

    PubMed

    Jecmenica-Lukic, Milica; Petrovic, Igor N; Pekmezovic, Tatjana; Kostic, Vladimir S

    2014-08-01

    Progressive supranuclear palsy (PSP) and parkinsonian subtype of multiple system atrophy (MSA-P) are, after Parkinson's disease (PD), the most common forms of neurodegenerative parkinsonism. Clinical heterogeneity of PSP includes two main variants, Richardson syndrome (PSP-RS) and PSP-parkinsonism (PSP-P). Clinical differentiation between them may be impossible at least during the first 2 years of the disease. Little is known about the differences in natural course of PSP-RS and PSP-P and, therefore, in this study we prospectively followed the clinical outcomes of consecutive, pathologically unconfirmed patients with the clinical diagnoses of PSP-RS (51 patients), PSP-P (21 patients) and MSA-P (49 patients). Estimated mean survival time was 11.2 years for PSP-P, 6.8 years for PSP-RS, and 7.9 years for MSA-P, where a 5-year survival probabilities were 90, 66 and 78 %, respectively. More disabling course of PSP-RS compared to PSP-P was also highlighted through the higher number of milestones reached in the first 3 years of the disease, as well as in the trend to reach all clinical milestones earlier. We found that PSP-P variant had a more favorable course with longer survival, not only when compared to PSP-RS, but also when compared to another form of atypical parkinsonism, MSA-P.

  9. Adenovirus encoding human platelet-derived growth factor-B delivered to alveolar bone defects exhibits safety and biodistribution profiles favorable for clinical use.

    PubMed

    Chang, Po-Chun; Cirelli, Joni A; Jin, Qiming; Seol, Yang-Jo; Sugai, James V; D'Silva, Nisha J; Danciu, Theodora E; Chandler, Lois A; Sosnowski, Barbara A; Giannobile, William V

    2009-05-01

    Platelet-derived growth factor (PDGF) gene therapy offers promise for tissue engineering of tooth-supporting alveolar bone defects. To date, limited information exists regarding the safety profile and systemic biodistribution of PDGF gene therapy vectors when delivered locally to periodontal osseous defects. The aim of this preclinical study was to determine the safety profile of adenovirus encoding the PDGF-B gene (AdPDGF-B) delivered in a collagen matrix to periodontal lesions. Standardized alveolar bone defects were created in rats, followed by delivery of matrix alone or containing AdPDGF-B at 5.5 x 10(8) or 5.5 x 10(9) plaque-forming units/ml. The regenerative response was confirmed histologically. Gross clinical observations, hematology, and blood chemistries were monitored to evaluate systemic involvement. Bioluminescence and quantitative polymerase chain reaction were used to assess vector biodistribution. No significant histopathological changes were noted during the investigation. Minor alterations in specific hematological and blood chemistries were seen; however, most parameters were within the normal range for all groups. Bioluminescence analysis revealed vector distribution at the axillary lymph nodes during the first 2 weeks with subsequent return to baseline levels. AdPDGF-B was well contained within the localized osseous defect area without viremia or distant organ involvement. These results indicate that AdPDGF-B delivered in a collagen matrix exhibits acceptable safety profiles for possible use in human clinical studies.

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

    PubMed

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

    2016-09-01

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

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

    PubMed

    Gillis, Anne M

    2017-02-07

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

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

    PubMed

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

    2016-12-21

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

  13. 77 FR 66848 - Minimum Clinically Important Difference: An Outcome Metric in Orthopaedic Device Science and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-11-07

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

  14. Correlation of Acute M1 Middle Cerebral Artery Thrombus Location with Endovascular Treatment Success and Clinical Outcome

    PubMed Central

    Pavabvash, Seyedmehdi; Taleb, Shayandokht; Majidi, Shahram; Qureshi, Adnan I.

    2017-01-01

    Purpose The location of the arterial occlusion can help with prognostication and treatment triage of acute stroke patients. We aimed to determine the effects of M1 distance-to-thrombus on angiographic recanalization success rate and clinical outcome following endovascular treatment of acute M1 occlusion. Methods All acute ischemic stroke patients with M1 segment middle cerebral artery (MCA) occlusion on admission CT angiography (CTA) who underwent endovascular treatment were analyzed. The distance between thrombus origin and internal carotid artery (ICA) bifurcation was measured on admission CTA. The modified thrombolysis in cerebral infarction (mTICI) grades 2b (>50% of distal branch filling) and 3 (complete) were considered as successful recanalization. Favorable outcome was defined by 3-month follow-up modified Rankin scale (mRs) score ≤2. Results Successful recanalization was achieved in 24 (71%) of 34 consecutive patients included in this study. The M1 distance-to-thrombus was shorter among patients with successful recanalization (5.4 ± 5.4 mm) versus those without (11.3 ± 7.6 mm, p = 0.015). The successful recanalization rate was higher among patients with M1 distance-to-thrombus ≤6 mm (odds ratio: 8, 95% confidence interval: 1.37–46.81, p = 0.023) compared with those with distance-to-thrombus >6 mm. There was no significant correlation between M1 distance-to-thrombus and 3-month mRs (rho: 0.131, p = 0.461); however, the distance-to-thrombus negatively correlated with admission National Institutes of Health Stroke Scale (NIHSS) scores (rho: −0.350, p=0.043). On the other hand, successful recanalization and admission NIHSS score were the only independent predictors of favorable outcome. Conclusion Shorter distance of M1 thrombus from ICA bifurcation is associated with higher rate of successful recanalization following endovascular treatment. PMID:28243346

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

    PubMed Central

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

    2012-01-01

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

  16. MMP2 and MMP9 serum levels are associated with favorable outcome in patients with inflammatory breast cancer treated with bevacizumab-based neoadjuvant chemotherapy in the BEVERLY-2 study

    PubMed Central

    Tabouret, Emeline; Bertucci, François; Pierga, Jean-Yves; Petit, Thierry; Levy, Christelle; Ferrero, Jean-Marc; Campone, Mario; Gligorov, Joseph; Lerebours, Florence; Roché, Henri; Bachelot, Thomas; van Laere, Steven; Ueno, Naoto T.; Toiron, Yves; Finetti, Pascal; Birnbaum, Daniel; Borg, Jean-Paul; Viens, Patrice

    2016-01-01

    Purpose Addition of bevacizumab to trastuzumab-based neoadjuvant chemotherapy in HER2-positive inflammatory breast cancer (IBC) was associated with favorable outcome in the BEVERLY-2 phase II trial. Circulating levels of matrix metalloproteinases (MMP) 2 and 9 were correlated to high response rate and prolonged survival in high-grade glioma treated with bevacizumab. We examined the prognostic impact of MMP2 and MMP9 serum levels in BEVERLY-2 patients. Experimental design MMP2 and MMP9 serum levels were assessed using ELISA at baseline and before surgery in 45/52 available samples. Correlations were tested with pathological complete response (pCR), disease-free survival (DFS) and overall survival (OS). Results Baseline (b) MMP2 and MMP9 serum levels were independent from patient characteristics and circulating tumor or endothelial cells, and were not correlated to pCR. High bMMP2 was correlated to better DFS (p=0.001) and OS (p=0.032), while low bMMP9 was correlated to better OS (p=0.022) and tended to be associated with longer DFS (p=0.071). In multivariate analyses, bMMP2 (p=0.003, Hazard Ratio [HR]: 0.115) and bMMP9 (p=0.041, HR: 3.511) remained correlated to DFS. As continuous variables, bMMP2 was associated with relapse (p=0.002) and death (p=0.049), while bMMP9 was associated with death (p=0.035). During treatment, significant increase in MMP2 and decrease in MMP9 levels (p<0.001 for both) were observed in 100% and 87% of patients respectively. Conclusions High bMMP2 and low bMMP9 serum levels were associated with better survival in HER2-positive IBC patients treated with bevacizumab- and trastuzumab-based neoadjuvant chemotherapy. Their predictive value of bevacizumab benefit should be evaluated in a randomized trial. PMID:26921265

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

    PubMed

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

    2000-01-01

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

  18. Clinical characteristics and long-term outcome of surgery for hypothalamic hamartoma in children with refractory epilepsy

    PubMed Central

    Jayalakshmi, Sita; Panigrahi, Manas; Reddy, Rajesh; Somayajula, Shanmukhi

    2014-01-01

    Context: Hypothalamic hamartomas (HH) are ectopic masses of neuronal and glial tissue most commonly presenting with medically refractory gelastic seizures with evolution to other seizure types. They are also associated with cognitive and behavioral problems to varying extent. Surgery has been found to improve quality of life in more than 50% of patients. Aim: To evaluate the clinical characteristics and long-term outcome of surgery in children with HH and refractory epilepsy. Materials and Methods: A retrospective analysis of presurgical, surgical, and postsurgical data of six children who underwent surgery for HH and had at least 3 years follow-up was performed. Results: Six children (male: female = 5:1) aged 3-16 years (at the time of surgery) underwent surgical resection of HH for refractory epilepsy. At last follow-up (range 3-9 years), three children were in Engel's class I, two in Class II, and one in class III outcome. Significant improvement in behavior, quality of life was noted in four children; while the change in intelligence quotient (IQ) was marginal. Conclusions: Medically refractory epilepsy associated with behavioral and cognitive dysfunction is the most common presentation of HH. Open surgical resection is safe with favorable outcome of epilepsy in 50% with significant improvement in behavior and marginal change in cognitive functions. PMID:24753658

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

    PubMed

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

    2016-07-01

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

  20. Long-Term Outcome for Clinically Localized Prostate Cancer Treated With Permanent Interstitial Brachytherapy

    SciTech Connect

    Taira, Al V.; Merrick, Gregory S.; Butler, Wayne M.; Galbreath, Robert W.; Lief, Jonathan; Adamovich, Edward; Wallner, Kent E.

    2011-04-01

    Purpose: To present the largest series of prostate cancer brachytherapy patients treated with modern brachytherapy techniques and postimplant day 0 dosimetric evaluation. Methods and Materials: Between April 1995 and July 2006, 1,656 consecutive patients were treated with permanent interstitial brachytherapy. Risk group stratification was carried out according to the Mt. Sinai guidelines. Median follow-up was 7.0 years. The median day 0 minimum dose covering at least 90% of the target volume was 118.8% of the prescription dose. Cause of death was determined for each deceased patient. Multiple clinical, treatment, and dosimetric parameters were evaluated for impact on the evaluated survival parameters. Results: At 12 years, biochemical progression-free survival (bPFS), cause-specific survival (CSS), and overall survival (OS) for the entire cohort was 95.6%, 98.2%, and 72.6%, respectively. For low-, intermediate-, and high-risk patients, bPFS was 98.6%, 96.5%, and 90.5%; CSS was 99.8%, 99.3%, and 95.2%; and OS was 77.5%, 71.1%, and 69.2%, respectively. For biochemically controlled patients, the median posttreatment prostate-specific antigen (PSA) concentration was 0.02 ng/ml. bPFS was most closely related to percent positive biopsy specimens and risk group, while Gleason score was the strongest predictor of CSS. OS was best predicted by patient age, hypertension, diabetes, and tobacco use. At 12 years, biochemical failure and cause-specific mortality were 1.8% and 0.2%, 5.1% and 2.1%, and 10.4% and 7.1% for Gleason scores 5 to 6 and 7 and {>=}8, respectively. Conclusions: Excellent long-term outcomes are achievable with high-quality brachytherapy for low-, intermediate-, and high-risk patients. These results compare favorably to alternative treatment modalities including radical prostatectomy.

  1. Proton Radiotherapy for Pediatric Central Nervous System Germ Cell Tumors: Early Clinical Outcomes

    SciTech Connect

    MacDonald, Shannon M.; Trofimov, Alexei; Safai, Sairos; Adams, Judith; Fullerton, Barbara; Ebb, David; Tarbell, Nancy J.; Yock, Torunn I.

    2011-01-01

    Purpose: To report early clinical outcomes for children with central nervous system (CNS) germ cell tumors treated with protons; to compare dose distributions for intensity-modulated photon radiotherapy (IMRT), three-dimensional conformal proton radiation (3D-CPT), and intensity-modulated proton therapy with pencil beam scanning (IMPT) for whole-ventricular irradiation with and without an involved-field boost. Methods and Materials: All children with CNS germinoma or nongerminomatous germ cell tumor who received treatment at the Massachusetts General Hospital between 1998 and 2007 were included in this study. The IMRT, 3D-CPT, and IMPT plans were generated and compared for a representative case. Results: Twenty-two patients were treated with 3D-CPT. At a median follow-up of 28 months, there were no CNS recurrences; 1 patient had a recurrence outside the CNS. Local control, progression-free survival, and overall survival rates were 100%, 95%, and 100%, respectively. Comparable tumor volume coverage was achieved with IMRT, 3D-CPT, and IMPT. Substantial normal tissue sparing was seen with any form of proton therapy as compared with IMRT. The use of IMPT may yield additional sparing of the brain and temporal lobes. Conclusions: Preliminary disease control with proton therapy compares favorably to the literature. Dosimetric comparisons demonstrate the advantage of proton radiation over IMRT for whole-ventricle radiation. Superior dose distributions were accomplished with fewer beam angles utilizing 3D-CPT and scanned protons. Intensity-modulated proton therapy with pencil beam scanning may improve dose distribution as compared with 3D-CPT for this treatment.

  2. Invasion patterns in stage I endometrioid and mucinous ovarian carcinomas: a clinicopathologic analysis emphasizing favorable outcomes in carcinomas without destructive stromal invasion and the occasional malignant course of carcinomas with limited destructive stromal invasion.

    PubMed

    Chen, Shirley; Leitao, Mario M; Tornos, Carmen; Soslow, Robert A

    2005-07-01

    Stage I, low-grade endometrioid and mucinous ovarian carcinomas have an excellent prognosis. Published data have suggested that destructive stromal invasion, a relatively uncommon finding in these tumors, is a poor prognostic factor. We investigated this by studying all FIGO stage I, grades 1 and 2 (of 3) endometrioid and mucinous ovarian carcinomas that were surgically staged at the Memorial Sloan-Kettering Cancer Center from 1980 to 2000. We undertook a careful review of all available slides using current diagnostic criteria and correlated histopathologic indices with clinical outcome data. Cases studied included 13 endometrioid ovarian carcinomas (stage IA, eight; stage IC, five) and six intestinal mucinous ovarian carcinomas (stage IA, three; stage IC, three). All of the tumors contained areas of expansile invasion, greater than that acceptable for microinvasion, and were thus diagnosed as carcinomas instead of borderline tumors. Nevertheless, nearly all demonstrated borderline tumor (noninvasive) components. Six tumors contained at least one focus of destructive stromal invasion (two endometrioid and four mucinous ovarian carcinomas). Four additional cases showed a focus suspicious for but not diagnostic of destructive invasion ('indeterminate for destructive invasion') (two endometrioid and two mucinous ovarian carcinomas). Follow-up data were available for 17 patients. The median follow-up was 81 months (range, 9-161 months). In all, 14 patients were alive with no evidence of disease (expansile invasion alone, eight; destructive stromal invasion, four; and indeterminate for destructive invasion, two). Three patients died of their disease (destructive stromal invasion, two; and indeterminate for destructive invasion, one). The size, number, and nuclear grade of destructive stromal invasion foci did not appear to have an impact on survival in this relatively limited number of patients. Outcome data in patients with stage I, low-grade endometrioid and mucinous

  3. Clinical Characteristics, Treatment Outcomes, and Resistance Mutations Associated with Macrolide-Resistant Mycobacterium avium Complex Lung Disease.

    PubMed

    Moon, Seong Mi; Park, Hye Yun; Kim, Su-Young; Jhun, Byung Woo; Lee, Hyun; Jeon, Kyeongman; Kim, Dae Hun; Huh, Hee Jae; Ki, Chang-Seok; Lee, Nam Yong; Kim, Hong Kwan; Choi, Yong Soo; Kim, Jhingook; Lee, Seung-Heon; Kim, Chang Ki; Shin, Sung Jae; Daley, Charles L; Koh, Won-Jung

    2016-11-01

    Macrolide antibiotics are key components of the multidrug treatment regimen for treating lung disease (LD) due to Mycobacterium avium complex (MAC). Despite the emergence of macrolide resistance, limited data are available on macrolide-resistant MAC-LD. This study evaluated the clinical features and treatment outcomes of patients with macrolide-resistant MAC-LD and the molecular characteristics of the macrolide-resistant isolates. A retrospective review of the medical records of 34 patients with macrolide-resistant MAC-LD who were diagnosed between January 2002 and December 2014 was performed, along with genetic analysis of 28 clinical isolates. Nineteen (56%) patients had the fibrocavitary form of MAC-LD, and 15 (44%) had the nodular bronchiectatic form. M. intracellulare was the etiologic organism in 21 (62%) patients. Approximately two-thirds (22/34 [65%]) of the patients had been treated with currently recommended multidrug regimens that included macrolide, ethambutol, and rifamycin prior to the emergence of macrolide resistance, and none had been treated with macrolide monotherapy. The median duration of treatment after the detection of macrolide resistance was 23.0 months (interquartile range, 16.8 to 45.3 months). Treatment outcomes were poor after the development of macrolide resistance, with favorable treatment outcomes achieved in only five (15%) patients, including two patients who underwent surgical resection. One-, 3-, and 5-year mortality rates were 9, 24, and 47%, respectively. Molecular analysis of 28 clinical isolates revealed that 96% (27/28) had point mutations at position 2058 or 2059 of the 23S rRNA gene. Our analyses indicate that more effective therapy is needed to treat macrolide-resistant MAC-LD and prevent its development.

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

    PubMed

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

    2016-12-01

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

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

    PubMed

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

    2012-01-01

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

  6. High IFIT1 expression predicts improved clinical outcome, and IFIT1 along with MGMT more accurately predicts prognosis in newly diagnosed glioblastoma.

    PubMed

    Zhang, Jin-Feng; Chen, Yao; Lin, Guo-Shi; Zhang, Jian-Dong; Tang, Wen-Long; Huang, Jian-Huang; Chen, Jin-Shou; Wang, Xing-Fu; Lin, Zhi-Xiong

    2016-06-01

    Interferon-induced protein with tetratricopeptide repeat 1 (IFIT1) plays a key role in growth suppression and apoptosis promotion in cancer cells. Interferon was reported to induce the expression of IFIT1 and inhibit the expression of O-6-methylguanine-DNA methyltransferase (MGMT).This study aimed to investigate the expression of IFIT1, the correlation between IFIT1 and MGMT, and their impact on the clinical outcome in newly diagnosed glioblastoma. The expression of IFIT1 and MGMT and their correlation were investigated in the tumor tissues from 70 patients with newly diagnosed glioblastoma. The effects on progression-free survival and overall survival were evaluated. Of 70 cases, 57 (81.4%) tissue samples showed high expression of IFIT1 by immunostaining. The χ(2) test indicated that the expression of IFIT1 and MGMT was negatively correlated (r = -0.288, P = .016). Univariate and multivariate analyses confirmed high IFIT1 expression as a favorable prognostic indicator for progression-free survival (P = .005 and .017) and overall survival (P = .001 and .001), respectively. Patients with 2 favorable factors (high IFIT1 and low MGMT) had an improved prognosis as compared with others. The results demonstrated significantly increased expression of IFIT1 in newly diagnosed glioblastoma tissue. The negative correlation between IFIT1 and MGMT expression may be triggered by interferon. High IFIT1 can be a predictive biomarker of favorable clinical outcome, and IFIT1 along with MGMT more accurately predicts prognosis in newly diagnosed glioblastoma.

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

    PubMed

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

    2014-01-01

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

  8. 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

  9. 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

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

    PubMed

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

    2017-03-01

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

  11. Clinical outcome of transthoracic esophagectomy with thoracic duct resection

    PubMed Central

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

    2016-01-01

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

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

    PubMed

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

    2011-03-01

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

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

    PubMed Central

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

    2017-01-01

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

  14. 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.

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

    PubMed

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

    2014-04-01

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

  16. [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.

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

    ERIC Educational Resources Information Center

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

    2009-01-01

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

  18. 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…

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

    PubMed

    Wallace, C J

    1998-09-01

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

  20. Clinical Characteristics and Outcomes of Gastric Cancer Patients Aged over 80 Years: A Retrospective Case-Control Study

    PubMed Central

    Jung, Hwoon-Yong; Lee, Jeong Hoon; Jung, Kee Wook; Kim, Do Hoon; Choi, Kee Don; Song, Ho June; Lee, Gin Hyug; Kim, Jin-Ho; Han, Seungbong

    2016-01-01

    Background and Aims The average human life expectancy is increasing worldwide, thus the proportion of elderly gastric cancer patients is also increasing. In this case-control study, we investigated the clinical and oncologic outcomes of gastric cancer in patients over 80 years old. Methods From January 2004 to December 2010, 291 patients aged over 80 years old (case group) were diagnosed and treated with gastric cancer at Asan Medical Center, Seoul, Korea. From the same period, 291 patients aged 18 to 80 years old were selected as the control group. The clinical findings and clinical outcomes of gastric cancer were retrospectively reviewed and compared between the two groups. Results There were significant differences in the overall 5-year survival rate between the case and control groups (30.9% vs. 73.8%, respectively; P<0.001). In patients who received the curative treatment, overall 3- and 5-year survival rates showed 74.3% and 57.9% in case group and 91.6% and 86.5% in the control group. When analysis was confined to resectable elderly patients with a favorable performance, the curative resection group showed significantly better overall 3- and 5-year survival rates than the conservative treatment group (73.7% and 58.8% vs. 29.8% and 0%, respectively). Conclusions Although elderly gastric cancer patients show an advanced stage at diagnosis and poor prognosis compared with non-elderly patients, elderly patients with good performance could benefit from curative resection. Thus, the clinical decision whether to undergo curative resection or conservative management should be made on an individualized basis. PMID:27942044

  1. 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.

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

    PubMed

    Hussain, Samia; Knight, Simon R

    2016-11-01

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

  3. Systematic Review of the Association between Dairy Product Consumption and Risk of Cardiovascular-Related Clinical Outcomes.

    PubMed

    Drouin-Chartier, Jean-Philippe; Brassard, Didier; Tessier-Grenier, Maude; Côté, Julie Anne; Labonté, Marie-Ève; Desroches, Sophie; Couture, Patrick; Lamarche, Benoît

    2016-11-01

    The objective of this systematic review was to determine if dairy product consumption is detrimental, neutral, or beneficial to cardiovascular health and if the recommendation to consume reduced-fat as opposed to regular-fat dairy is evidence-based. A systematic review of meta-analyses of prospective population studies associating dairy consumption with cardiovascular disease (CVD), coronary artery disease (CAD), stroke, hypertension, metabolic syndrome (MetS), and type 2 diabetes (T2D) was conducted on the basis of the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) statement. Quality of evidence was rated by using the Grading of Recommendations Assessment, Development, and Evaluation scale. High-quality evidence supports favorable associations between total dairy intake and hypertension risk and between low-fat dairy and yogurt intake and the risk of T2D. Moderate-quality evidence suggests favorable associations between intakes of total dairy, low-fat dairy, cheese, and fermented dairy and the risk of stroke; intakes of low-fat dairy and milk and the risk of hypertension; total dairy and milk consumption and the risk of MetS; and total dairy and cheese and the risk of T2D. High- to moderate-quality evidence supports neutral associations between the consumption of total dairy, cheese, and yogurt and CVD risk; the consumption of any form of dairy, except for fermented, and CAD risk; the consumption of regular- and high-fat dairy, milk, and yogurt and stroke risk; the consumption of regular- and high-fat dairy, cheese, yogurt, and fermented dairy and hypertension risk; and the consumption of regular- and high-fat dairy, milk, and fermented dairy and T2D risk. Data from this systematic review indicate that the consumption of various forms of dairy products shows either favorable or neutral associations with cardiovascular-related clinical outcomes. The review also emphasizes that further research is urgently needed to compare the impact of

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

    PubMed Central

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

    2000-01-01

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

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

    PubMed

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

    2009-08-15

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

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

    PubMed

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

    1986-01-01

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

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

    PubMed Central

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

    2011-01-01

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

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

    PubMed

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

    2009-10-01

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

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

    PubMed

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

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

  10. 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.

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

    PubMed

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

    2011-01-01

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

  12. Combinations in multimodality treatments and clinical outcomes during cancer

    PubMed Central

    Zhang, Xiao-Ying; Zhang, Pei-Ying

    2016-01-01

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

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

    PubMed

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

    1978-01-01

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

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

    PubMed

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

    2014-01-01

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

  15. Is There an Association Between the “Critical Shoulder Angle” and Clinical Outcome after Rotator Cuff Repair?

    PubMed Central

    Kirsch, Jacob Matthew; Nathani, Amit; Robbins, Christopher; Gagnier, Joel Joseph; Bedi, Asheesh; Miller, Bruce S.

    2016-01-01

    Objectives: Variations in scapular morphology have been associated with the development of atraumatic rotator cuff tears (RCT). Current theories suggest a morphologic predisposition for altered shoulder biomechanics favoring the development of RCTs. The critical shoulder angle (CSA) is a radiographic measure that accounts for both glenoid inclination and lateral extension of the acromion, and angles >35 degrees are reported to be correlated with the development of degenerative RCTs. The impact of the CSA on outcomes following rotator cuff repair (RCR) has not previously been investigated. The purpose of this study was to investigate the relationship between the CSA and clinical outcomes after rotator cuff repair. Methods: As part of a prospective observational cohort study we obtained CSA measurements for 144 patients with documented full-thickness RCTs who were followed up for a minimum of 48 weeks. Patients were then stratified based on RCT etiology and treatment. Demographic data as well as The Western Ontario Rotator Cuff Index (WORC), American Shoulder and Elbow Surgeons (ASES) score and Visual Analog Scale (VAS) for pain were collected at baseline, four, eight, 16, 32 and 48 weeks. The CSA for all of the patients was measured retrospectively, with all assessors being blinded to the data and we calculated interclass correlation coefficients (ICC) to measure agreement. The statistical analysis included longitudinal multilevel regression modeling to investigate the association of the CSA and the WORC, ASES and VAS for pain. Results: Controlling for demographic and clinical characteristics, patients with CSAs less than 38 degrees reported better outcome scores over time compared to those with CSAs greater than 38 degrees (WORC: B=-106.6, p=0.025, ASES: B=4.83, p=0.0001, VAS: B=-12.99, p=0.0001). Interobserver and intraobserver reliability for CSA measurements resulted in an ICC of 0.969 and 0.982 respectively, indicating excellent agreement. Conclusion: We found

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

    PubMed

    Mochtar, I; Al-Monjed, M F

    2015-06-09

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

  17. Clinical-Pathologic Features and Long-Term Outcomes of Tubular Carcinoma of the Breast Compared With Invasive Ductal Carcinoma Treated With Breast Conservation Therapy

    SciTech Connect

    Liu, Gene-Fu F.; Yang Qifeng; Haffty, Bruce G.; Moran, Meena S.

    2009-12-01

    Purpose: To evaluate our institutional experience of treating tubular carcinoma of the breast (TC) and invasive ductal carcinoma (IDC) with conservative surgery and radiation therapy, to compare clinical-pathologic features and long-term outcomes. Methods and Materials: A review of our institution's tumor registry from 1975 to 2007, followed by a central pathology review of available slides, yielded 71 cases of Stage I/II TC and 2,238 cases of Stage I/II IDC treated with breast conservation therapy. Clinical-pathologic features and outcomes were analyzed by subtype to detect significant differences. Results: The median follow-up was 7 years. The TC cohort presented more frequently with pT1 disease (97% vs. 80%, p = 0.0007), pN0 disease (95% vs. 74%, p = 0.0004), hormone-receptor positivity (ER+, 89% vs. 62%, p = 0.0001; PR+, 81% vs. 52%, p = 0.0001), and HER-2 negativity (89% vs. 71%, p = 0.04). Clinical outcomes also favored the TC cohort, with lower rates of breast cancer-related death (1% vs. 10%; p = 0.0109) and distant metastasis (1% vs. 13%; p = 0.0028) and higher rates of 10-year overall (90% vs. 80%; p = 0.033), cause-specific (99% vs. 86%; p = 0.011), and disease-free (99% vs. 82%; p = 0.003) survival. There was a nonsignificant trend toward improved breast cancer relapse-free survival for the TC cohort (95% vs. 87%; p = 0.062) but no difference in nodal relapse-free survival or contralateral breast cancer relapse-free survival (all p values >0.05) between the cohorts. Conclusion: Our institutional experience suggests that TC, when compared with IDC, is associated with more favorable clinical-pathologic features and comparable, if not superior, outcomes after breast conservation therapy, suggesting the appropriateness of a conservative approach to this rare subtype.

  18. Influence of hemodialysis on clinical outcomes after lung transplantation

    PubMed Central

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

    2014-01-01

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

  19. Iron administration and clinical outcomes in hemodialysis patients.

    PubMed

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

    2002-03-01

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

  20. 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.

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

    PubMed Central

    Singh, Sarman

    2016-01-01

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

  2. 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

  3. 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.

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

    PubMed

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

    2016-10-01

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

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

    PubMed Central

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

    2010-01-01

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

  6. 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

  7. 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.

  8. 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

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

    PubMed

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

    2006-03-01

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

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

    PubMed

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

    2016-02-01

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

  11. 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.

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

    PubMed Central

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

    2016-01-01

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

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

    PubMed

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

    2012-02-20

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

  14. EMT-induced metabolite signature identifies poor clinical outcome

    PubMed Central

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

    2015-01-01

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

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

    PubMed

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

    2016-12-01

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

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

    PubMed Central

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

    2016-01-01

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

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

    PubMed

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

    2015-01-01

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

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

    PubMed

    Johnson, Pierce; Lee, Daniel K

    2015-01-01

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

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

    PubMed

    Rambod, Mehdi; Tolouian, Ramin

    2012-07-01

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

  20. 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

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

    PubMed Central

    2016-01-01

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

  2. 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

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

    PubMed

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

    2013-01-01

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

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

    PubMed

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

    2016-01-01

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

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

    PubMed

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

    2007-02-01

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

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

    PubMed Central

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

    2015-01-01

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

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

    PubMed Central

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

    2016-01-01

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

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

    PubMed

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

    2012-03-01

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

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

    PubMed

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

    2009-01-01

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

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

    PubMed

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

    2012-05-09

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

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

    PubMed Central

    Barbic, Skye P.; Cano, Stefan J.

    2016-01-01

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

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

    PubMed Central

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

    2012-01-01

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

  13. 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.

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

    PubMed

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

    2013-01-01

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

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

    PubMed

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

    2017-01-21

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

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

    PubMed

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

    2014-01-01

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

  17. 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

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

    PubMed Central

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

    2016-01-01

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

  19. Favorable prognosis for children with Pfeiffer syndrome types 2 and 3: implications for classification.

    PubMed

    Robin, N H; Scott, J A; Arnold, J E; Goldstein, J A; Shilling, B B; Marion, R W; Cohen, M M

    1998-01-23

    Pfeiffer syndrome (PS) is an autosomal dominant condition comprising bilateral coronal craniosynostosis, midface hypoplasia with a beaked nasal tip, and broad and medially deviated thumbs and great toes. It is a clinically variable disorder and has been divided into three subtypes [Cohen, 1993: Am J Med Genet 45:300-307]. Type 1 represents the less severe cases, while types 2 and 3 are the more severe cases. These latter types tend to have a higher risk for neurodevelopmental problems and a reduced life expectancy. Here we review the clinical course of seven children with PS type 3. All of these children had severe manifestations of PS; however, development was essentially normal in three, mild delay was noted in two, and moderate delay in one. Favorable outcomes in children with types 2 and 3 PS were also documented by Moore et al. [1995: Cleft Pal-Craniofac J 32:62-70]. These cases illustrate that while children with PS types 2 and 3 have an increased risk for neurodevelopmental difficulties, a favorable outcome can be achieved in some cases with aggressive medical and surgical management. Finally, although such management should be the rule for PS types 2 and 3, it needs to be remembered that normal outcome is not the rule. The prognosis for favorable neurodevelopmental outcome and/or life expectancy remains guarded in most cases.

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

    PubMed Central

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

    2016-01-01

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

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

    PubMed

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

    2016-10-01

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

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

    PubMed Central

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

    2003-01-01

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

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

    PubMed Central

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

    2013-01-01

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

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

    PubMed Central

    Worrall, G; Chaulk, P; Freake, D

    1997-01-01

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

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

    DTIC Science & Technology

    2015-06-07

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

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

    PubMed Central

    Shah, Sachin P.; Mehra, Mandeep R.

    2016-01-01

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

  8. Familial risk factors favoring drug addiction onset.

    PubMed

    Zimić, Jadranka Ivandić; Jukić, Vlado

    2012-01-01

    This study, primarily aimed at identification of familial risk factors favoring drug addiction onset, was carried out throughout 2008 and 2009. The study comprised a total of 146 addicts and 134 control subjects. Based on the study outcome, it can be concluded that in the families the addicts were born into, familial risk factors capable of influencing their psychosocial development and favoring drug addiction onset had been statistically more frequently encountered during childhood and adolescence as compared to the controls. The results also indicated the need for further research into familial interrelations and the structure of the families addicts were born into, as well as the need for the implementation of family-based approaches to both drug addiction prevention and therapy.

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

    PubMed

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

    2004-11-01

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

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

    PubMed

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

    2013-01-16

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

  11. Non-human Immunodeficiency Virus-related Ocular Syphilis in a Korean Population: Clinical Manifestations and Treatment Outcomes

    PubMed Central

    Kim, Yonguk; Kwak, Hyung Woo

    2016-01-01

    Purpose To describe the clinical manifestations and treatment outcomes of ocular syphilis in patients without human immunodeficiency virus (HIV) infection. Methods A total of 45 eyes from 39 patients with ocular syphilis confirmed by serologic tests were reviewed retrospectively. The included cases were all non-HIV-infected patients presenting with intraocular inflammation from 2002 to 2014 at Kyung Hee University Hospital. Medical records of 45 eyes were analyzed and included best-corrected visual acuity and ophthalmologic examination findings of the anterior and posterior segments to determine the focus of inflammation. Optical coherence tomography and fluorescein angiography findings as well as both medical and surgical management were also analyzed. Results The mean patient age was 61.0 years (range, 37 to 89 years). Bilateral ocular involvement occurred in 6 patients (15.4%), and diagnoses at presentation were most frequently related to posterior uveitis (38%), followed by panuveitis (29%) and optic neuritis (11%). Isolated interstitial keratitis and intermediate uveitis were uncommon (4%, both). Twenty-eight eyes (62.2%) were treated with penicillin, and 11 eyes (24.4%) underwent surgical treatment. The mean baseline best corrected visual acuity was 0.79 ± 0.59 (mean ± standard deviation, logarithm of the minimum angle of resolution) and significantly improved to 0.60 ± 0.63 at the final follow-up after treatment (p = 0.019). Mean visual improvement was significantly greater in the penicillin-treated group (p = 0.001). Visual impairment at the final visit occurred in 11 eyes (24.4%). Among the visual impairment group, 10 eyes (90.1%) had posterior segment-involving uveitis. Conclusions Visual outcomes of treated, non-HIV-related ocular syphilis were favorable regardless of time to presentation. Posterior segment-involving uveitis at presentation was associated with poor visual outcome. PMID:27729756

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

    PubMed

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

    2011-07-01

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

  13. 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

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

    PubMed Central

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

    2013-01-01

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

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

    PubMed Central

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

    2015-01-01

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

  16. 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…

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

    PubMed

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

    2017-04-01

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

  18. 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

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

    PubMed

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

    2016-12-01

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

  20. Laminoplasty versus laminectomy and fusion for multilevel cervical myelopathy: a meta-analysis of clinical and radiological outcomes.

    PubMed

    Lee, Chang-Hyun; Lee, Jaebong; Kang, James D; Hyun, Seung-Jae; Kim, Ki-Jeong; Jahng, Tae-Ahn; Kim, Hyun-Jib

    2015-06-01

    OBJECT Posterior cervical surgery, expansive laminoplasty (EL) or laminectomy followed by fusion (LF), is usually performed in patients with multilevel (≥ 3) cervical spondylotic myelopathy (CSM). However, the superiority of either of these techniques is still open to debate. The aim of this study was to compare clinical outcomes and postoperative kyphosis in patients undergoing EL versus LF by performing a meta-analysis. METHODS Included in the meta-analysis were all studies of EL versus LF in adults with multilevel CSM in MEDLINE (PubMed), EMBASE, and the Cochrane library. A random-effects model was applied to pool data using the mean difference (MD) for continuous outcomes, such as the Japanese Orthopaedic Association (JOA) grade, the cervical curvature index (CCI), and the visual analog scale (VAS) score for neck pain. RESULTS Seven studies comprising 302 and 290 patients treated with EL and LF, respectively, were included in the final analyses. Both treatment groups showed slight cervical lordosis and moderate neck pain in the baseline state. Both groups were similarly improved in JOA grade (MD 0.09, 95% CI -0.37 to 0.54, p = 0.07) and neck pain VAS score (MD -0.33, 95% CI -1.50 to 0.84, p = 0.58). Both groups evenly lost cervical lordosis. In the LF group lordosis seemed to be preserved in long-term follow-up studies, although the difference between the 2 treatment groups was not statistically significant. CONCLUSIONS Both EL and LF lead to clinical improvement and loss of lordosis evenly. There is no evidence to support EL over LF in the treatment of multilevel CSM. Any superiority between EL and LF remains in question, although the LF group shows favorable long-term results.

  1. Viewpoint: Central adjudication of myocardial infarction in outcome-driven clinical trials--common patterns in TRITON, RECORD, and PLATO?

    PubMed

    Serebruany, Victor L; Atar, Dan

    2012-09-01

    Central adjudication in randomised controlled outcome-driven trials represents a traditional approach to maintain data integrity by applying uniformed rules for assessment of clinical events. It was the purpose of this investigation to determine the patterns of myocardial infarction (MI) adjudication in the TRITON, RECORD, and PLATO trials. We were matching centrally-adjudicated MI's (CAMI's) from the official trial publication with the site-reported MI (SRMI's) count from the Food and Drug Administration's secondary analyses for the investigational compounds prasugrel (TRITON), rosiglitazone (RECORD), and ticagrelor (PLATO). CAMI numbers showed a remarkable discrepancy to SRMI's by more than a doubling of the difference: from 72 to 145 events in TRITON favoring prasugrel (from a hazard ratio [HR]=0.76, p=0.08; to a HR=0.76, p<0.001), and from 44 to 89 events in favour of ticagrelor in PLATO (from a HR=0.94, p=0.095; to a HR=0.84, p<0.001). In contrast, in the RECORD trial, the CAMI count was less than the SRMI count (from 24 to 8 events, from a HR=1.42, p=0.93; to a HR=1.14, p=0.96), in this case diminishing cardiovascular hazards in favour of rosiglitazone. In conclusion, central adjudication in the TRITON, the RECORD, and the PLATO trial turned out to have a critical impact on study outcomes. Trial publications should in the future include site-reported major efficacy and safety endpoints to preserve data integrity. The regulatory authorities should consider independent audits when there is a major disagreement between centrally adjudicated and site reported events influencing the results of a major clinical trial.

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

    PubMed Central

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

    2015-01-01

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

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

    PubMed Central

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

    2015-01-01

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

  4. Impact of Ultrahigh Baseline PSA Levels on Biochemical and Clinical Outcomes in Two Radiation Therapy Oncology Group Prostate Clinical Trials

    SciTech Connect

    Rodrigues, George; Bae, Kyounghwa; Roach, Mack; Lawton, Colleen; Donnelly, Bryan; Grignon, David; Hanks, Gerald; Porter, Arthur; Lepor, Herbert; Sandler, Howard

    2011-06-01

    Purpose: To assess ultrahigh (UH; prostate-specific antigen [PSA]levels {>=}50 ng/ml) patient outcomes by comparison to other high-risk patient outcomes and to identify outcome predictors. Methods and Materials: Prostate cancer patients (PCP) from two Phase III Radiation Therapy Oncology Group clinical trials (studies 9202 and 9413) were divided into two groups: high-risk patients with and without UH baseline PSA levels. Predictive variables included age, Gleason score, clinical T stage, Karnofsky performance score, and treatment arm. Outcomes included overall survival (OS), distant metastasis (DM), and biochemical failure (BF). Unadjusted and adjusted hazard ratios (HRs) were calculated using either the Cox or Fine and Gray's regression model with associated 95% confidence intervals (CI) and p values. Results: There were 401 patients in the UH PSA group and 1,792 patients in the non-UH PSA PCP group of a total of 2,193 high-risk PCP. PCP with UH PSA were found to have inferior OS (HR, 1.19; 95% CI, 1.02-1.39, p = 0.02), DM (HR, 1.51; 95% CI, 1.19-1.92; p = 0.0006), and BF (HR, 1.50; 95% CI, 1.29-1.73; p < 0.0001) compared to other high-risk PCP. In the UH cohort, PSA level was found to be a significant factor for the risk of DM (HR, 1.01; 95% CI, 1.001-1.02) but not OS and BF. Gleason grades of 8 to 10 were found to consistently predict for poor OS, DM, and BF outcomes (with HR estimates ranging from 1.41-2.36) in both the high-risk cohort and the UH cohort multivariable analyses. Conclusions: UH PSA levels at diagnosis are related to detrimental changes in OS, DM, and BF. All three outcomes can be modeled by various combinations of all predictive variables tested.

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

    PubMed

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

    2016-10-01

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

  6. Cerebrolysin in vascular dementia: improvement of clinical outcome in a randomized, double-blind, placebo-controlled multicenter trial.

    PubMed

    Guekht, Alla B; Moessler, Herbert; Novak, Philipp H; Gusev, Evgenyi I

    2011-01-01

    No drug to treat vascular dementia (VaD) has yet been approved by the American or European authorities, leaving a large population of patients without effective therapy. Cerebrolysin has a long record of safety and might be efficacious in this condition. We conducted a large, multicenter, double-blind, placebo-controlled study in 242 patients meeting the criteria for VaD. The primary endpoint was the combined outcome of cognition (based on Alzheimer's Disease Assessment Scale Cognitive Subpart, Extended Version [ADAS-cog+] score) and overall clinical functioning (based on Clinician's Interview-Based Impression of Change plus Caregiver Input [CIBIC+] score) assessed after 24 weeks of treatment. Intravenous Cerebrolysin 20 mL was administered once daily over the course of 2 treatment cycles as add-on therapy to basic treatment with acetylsalicylic acid. The addition of Cerebrolysin was associated with significant improvement in both primary parameters. At week 24, ADAS-cog+ score improved by 10.6 points in the Cerebrolysin group, compared with 4.4 points in the placebo group (least squares mean difference, -6.17; P < .0001 vs placebo). CIBIC+ showed a mean improvement of 2.84 in the treatment arm and 3.68 in the placebo arm, a treatment difference of 0.84 (P < .0001 vs placebo). These findings were confirmed by responder analyses demonstrating higher rates in the Cerebrolysin group (ADAS-cog+ improvement of ≥4 points from baseline, 82.1% vs 52.2%; CIBIC+ score of <4 at week 24, 75.3% vs 37.4%; combined response in ADAS-cog+ and CIBIC+, 67.5% vs 27.0%). For Cerebrolysin, the odds ratio for achieving a favorable CIBIC+ response was 5.08 (P < .05), and that for achieving a favorable combined response was 5.63 (P < .05). Our data indicate that the addition of Cerebrolysin significantly improved clinical outcome, and that the benefits persisted for at least 24 weeks. Cerebrolysin was safe and well tolerated.

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

    PubMed Central

    2014-01-01

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

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

    PubMed Central

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

    2014-01-01

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

  9. 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

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

    PubMed Central

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

    2015-01-01

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

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

    PubMed Central

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

    2017-01-01

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

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

    PubMed

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

    2017-01-01

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

  14. 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

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

    PubMed Central

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

    2016-01-01

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

  16. Correlation of Ezrin Expression Pattern and Clinical Outcomes in Ewing Sarcoma

    PubMed Central

    Yin, Hong; McCracken, Courtney; Geng, Zhi; Shehata, Bahig M.; Olson, Thomas A.; Katzenstein, Howard M.; Wetmore, Cynthia

    2017-01-01

    Background. Ezrin is a membrane-cytoskeleton linker protein that has been associated with metastasis and poor outcomes in osteosarcoma and high-grade soft tissue sarcomas. The prognostic value of ezrin expression in Ewing sarcoma is unknown. Methods. The relationship between ezrin expression and outcome was analyzed in a cohort of 53 newly diagnosed Ewing sarcoma patients treated between 2000 and 2011. The intensity and proportion of cells with ezrin immunoreactivity were assessed in diagnostic tumor tissue using a semiquantitative scoring system to yield intensity and positivity scores for each tumor. Results. Ezrin expression was detected in 72% (38/53) of tumor samples. The proportion of patients with metastatic disease was equal in the positive and negative ezrin expression groups. There was no significant difference in the 5-year event-free survival (EFS) between patients with positive versus negative ezrin expression. Patients whose tumor sample showed high ezrin intensity had significantly better 5-year EFS when compared to patients with low/no ezrin intensity (78% versus 55%; P = 0.03). Conclusions. Ezrin expression can be detected in the majority of Ewing sarcoma tumor samples. Intense ezrin expression may be correlated with a favorable outcome; however further investigation with a larger cohort is needed to validate this finding. PMID:28246524

  17. 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

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

    PubMed Central

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

    2015-01-01

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

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

    PubMed Central

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

    2004-01-01

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

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

    PubMed

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

    2014-01-01

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

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

    PubMed

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

    2012-05-01

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

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

    PubMed Central

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

    2015-01-01

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

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

    PubMed

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

    2015-11-03

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

  4. Research Participant-Centered Outcomes at NIH-Supported Clinical Research Centers

    PubMed Central

    Kost, Rhonda G.; Lee, Laura N.; Yessis, Jennifer M.; Wesley, Robert; Alfano, Sandra; Alexander, Steven R.; Kassis, Sylvia Baedorf; Cola, Phil; Dozier, Ann; Ford, Dan E.; Harris, Paul; Kim, Emmelyn; Lee, Simon Craddock; O’Riordan, Gerri; Roth, Mary-Tara; Schuff, Kathryn; Wasser, June; Henderson, David K.; Coller, Barry S.

    2014-01-01

    Background Although research participation is essential for clinical investigation, few quantitative outcome measures exist to assess participants’ experiences. To address this, we developed and deployed a survey at 15 NIH-supported clinical research centers to assess participant-centered outcomes; we report responses from 4,961 participants. Methods Survey questions addressed core aspects of the research participants’ experience, including their overall rating, motivation, trust, and informed consent. We describe participant characteristics, responses to individual questions, and correlations among responses. Results Respondents broadly represented the research population in sex, race, and ethnicity. Seventy-three percent awarded top ratings to their overall research experience and 94% reported no pressure to enroll. Top ratings correlated with feeling treated with respect, listened to, and having access to the research team (R2=0.80 - 0.96). White participants trusted researchers (88%) than did non-white participants collectively (80%) (p<0.0001). Many participants felt fully prepared by the informed consent process (67%) and wanted to receive research results (72%). Conclusions Our survey demonstrates that a majority of participants at NIH-supported clinical research centers rate their research experience very positively and that participant-centered outcome measures identify actionable items for improvement of participant’s experiences, research protections, and the conduct of clinical investigation. PMID:24842076

  5. Association between susceptible genotypes to periodontitis and clinical outcomes of periodontal regenerative therapy: A systematic review

    PubMed Central

    Koidou, Vasiliki-Petros

    2016-01-01

    Background The aim of this review is to systematically investigate the effect of a susceptible genotype to periodontitis with the clinical outcomes of periodontal regeneration. Material and Methods Based on a focused question, an electronic search identified 155 unique citations. Three journals (Journal of Periodontology, Journal of Clinical Periodontology and Journal of Periodontal Research), references of relevant studies and review articles were hand-searched. Two independent reviewers implementing eligibility inclusion criteria selected the studies. Results Of the 155, four studies fulfilled the inclusion criteria. All studies were published between 2000 and 2004 and the samples’ size was 40 to 86 patients. Polymorphisms of Interleukin-1 (IL-1) gene were included in all. Three out of four studies failed to identify an association between susceptible genotypes to periodontitis and clinical outcomes of periodontal regeneration, while one found an association. The heterogeneity and small number of studies included prevented the conduct of a meta-analysis. No studies were identified evaluating the effect of other genotypes and as a result only IL-1 genotype studies were included. Conclusions Within the limits of the present review, no direct conclusion for the effect of a susceptible IL-1 genotype status to the clinical outcome after periodontal regeneration could be drawn. The need of more qualitative studies to explore a possible association emerges. Key words:Periodontitis, genotype, periodontal therapy, regeneration, susceptibility, systematic review. PMID:26946210

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

    PubMed Central

    Bushby, Kate; Connor, Edward

    2012-01-01

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

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

    PubMed Central

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

    2013-01-01

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

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

    PubMed

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

    2009-03-01

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

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

    PubMed Central

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

    2014-01-01

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

  10. Correlates of Polysomnographic Sleep Changes in Cocaine Dependence: Self-administration and Clinical Outcomes*

    PubMed Central

    Angarita, Gustavo A.; Canavan, Sofija V.; Forselius, Erica; Bessette, Andrew; Morgan, Peter T.

    2014-01-01

    Background Abstinence from chronic cocaine use is associated with abnormal sleep architecture. As sleep abnormalities are associated with clinical outcome in alcohol dependence, we hypothesized a similar relationship in cocaine dependence. Methods We report data from a cocaine self-administration study (N=12) and the placebo arm of a randomized clinical trial (N=20). Self-administration participants underwent three cocaine self-administration sessions during a three-week inpatient stay. Treatment participants underwent two weeks of inpatient followed by six weeks of outpatient treatment including once-weekly cognitive behavioral therapy. Measurements included polysomnography from early and late in abstinence during the inpatient stays. Clinical outcomes included amount of cocaine self-administered, urine tests, and self-reported use and withdrawal symptoms. Results Change in slow-wave sleep from early to late abstinence (ΔSWS; p=0.05), late abstinence rapid eye movement sleep (REM; p=0.002), and late abstinence total sleep time (p=0.02) were negatively correlated with the amount of cocaine self-administered. Early abstinence REM was positively correlated with withdrawal symptoms (p=0.02). Late abstinence REM was positively correlated with percent negative urines and maximum consecutive number of days abstinent (both p<0.001). ΔSWS was positively correlated with percent negative urines (p=0.03) and participants with increased SWS had greater percent negative urines (p=0.008) and maximum consecutive number of days abstinent (p=0.009). Conclusions Correlations between sleep deficits and amount of cocaine self-administered, clinical outcomes, and severity of withdrawal symptoms underscore the relevance of sleep in clinical outcomes in the treatment of cocaine dependence. PMID:25124303

  11. Clinical outcomes of 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

  12. Main Trunk and Division Middle Cerebral Artery Occlusions: Differences in Recanalization Times, Number of Stent Retriever Passes and Clinical Outcomes: A Single-Center Experience

    PubMed Central

    Qureshi, Ihtesham A.; Maud, Alberto; Cruz-Flores, Salvador; Rodriguez, Gustavo J.

    2016-01-01

    Background and Purpose In this article, we present our experience with the recanalization of the middle cerebral artery (MCA), we hypothesize that there are higher rates of recanalization with fewer stent retriever passes and better clinical outcomes in patients with division MCA occlusions. A more complex anatomy at the bifurcation may prevent a faster recanalization in main trunk MCA occlusions. Methods We retrospectively identified consecutive patients admitted with MCA occlusions who underwent mechanical thrombectomy using stent retrievers. We categorized patients into division MCA and main trunk MCA occlusions based on angiography. Variables were compared between the groups. We further analyzed patients with trunk MCA occlusions to identify reasons for delays in recanalization. Results There were 32 MCA occlusions that underwent mechanical thrombectomy and eligible for the analysis during the study period. Of those, 11 were main trunk MCA occlusions. Univariate analysis disclosed a trend toward a lower GP-to-recanalization time (p = 0.05) and a lower number of passes required for recanalization in division MCA occlusions. However, there was a significantly better outcome in patients with division MCA occlusion after multivariate analysis. Analyzing main trunk MCA occlusion data, we found that the need for more than one pass to achieve recanalization led to a trend toward a longer GP-to-recanalization time and a worse outcome. When the stent was placed in the dominant division, the chances of recanalization were significantly higher. Conclusions Division MCA occlusions have higher recanalization rates with fewer stent retriever passes and better clinical outcomes than main trunk MCA occlusions, likely due to a more favorable anatomy. Measures like placing the stent retriever in the dominant division may decrease recanalization times and improve clinical outcomes in main trunk MCA occlusions. PMID:27051403

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

    PubMed Central

    Sveréus, Sofia; Larsson, Kjell; Rehnberg, Clas

    2017-01-01

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

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

    PubMed

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

    2014-08-01

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

  15. The relationships between patients’ and caregivers’ beliefs about the causes of schizophrenia and clinical outcomes in Latin American countries

    PubMed Central

    Caqueo-Urízar, Alejandra; Boyer, Laurent; Baumstarck, Karine; Gilman, Stephen E.

    2015-01-01

    Beliefs about the causes of schizophrenia are thought to impact treatment outcomes. We investigated 3 theoretically opposing belief systems (biological, psychosocial, magical-religious) in relation to the severity of positive and negative symptoms and to attitudes towards medications. We recruited 253 patients with schizophrenia and their primary caregivers from public mental health clinics in Bolivia, Chile, and Peru. We assessed patients’ and caregivers’ beliefs about the causes of schizophrenia, which were used as predictors of symptom severity and medication attitudes in linear regression analyses. Patients’ scores on biological, psychosocial, and magical-religious beliefs were positively correlated with one another, indicating that these domains were not, as anticipated, “opposing.” Patients with higher levels of biological and psychosocial beliefs had significantly lower levels of positive and negative symptoms; in contrast, higher levels of magical-religious beliefs were associated with increased positive symptoms and less favorable attitudes towards medications. Patients’ belief systems are significant predictors of symptom severity and medication attitudes. Research is needed on the extent to which psychotherapeutic treatments for schizophrenia should bolster patients’ beliefs in the biological and psychosocial domains and weaken beliefs in the magical-religious domain; this research should also attend to the ethical considerations involved in intervening on belief systems cross-culturally. PMID:26188641

  16. Clinical comparison of patient outcomes following implantation of trifocal or bifocal intraocular lenses: a systematic review and meta-analysis

    PubMed Central

    Shen, Zeren; Lin, Yuchen; Zhu, Yanan; Liu, Xin; Yan, Jie; Yao, Ke

    2017-01-01

    To assess the visual effects of trifocal intraocular lenses (IOLs) compared to bifocal IOLs in cataract surgery, a meta-analysis of prospective comparative clinical trials (including 4 randomized controlled trials and 4 cohorts) was conducted. The defocus curves showed a better distance-corrected intermediate visual acuity (VA) for the trifocal group (MD −0.07; 95% CI, −0.10 to −0.05; p < 0.00001), while the VA outcomes showed no significant difference in distance VA (MD −0.03; 95% CI, −0.06 to 0.01; p = 0.13 for uncorrected distance VA and MD −0.00; 95% CI, −0.01 to 0.01; p = 0.78 for distance-corrected distance VA), near VA (MD −0.01; 95% CI, −0.07 to 0.04; p = 0.68 for uncorrected near VA and MD −0.01; 95% CI, −0.06 to 0.04; p = 0.66 for distance-corrected near VA) or refraction between the two groups. Contrast sensitivity and subjective visual quality yielded less conclusive results. Overall, a patient may achieve better intermediate VA with a trifocal IOL than with a bifocal IOL without any adverse effect on distance or near VA. The findings on contrast sensitivity and subjective visual quality were heterogeneous, with no clear results favoring either option.

  17. The relationships between patients' and caregivers' beliefs about the causes of schizophrenia and clinical outcomes in Latin American countries.

    PubMed

    Caqueo-Urízar, Alejandra; Boyer, Laurent; Baumstarck, Karine; Gilman, Stephen E

    2015-09-30

    Beliefs about the causes of schizophrenia are thought to impact treatment outcomes. We investigated 3 theoretically opposing belief systems (biological, psychosocial, magical-religious) in relation to the severity of positive and negative symptoms and to attitudes towards medications. We recruited 253 patients with schizophrenia and their primary caregivers from public mental health clinics in Bolivia, Chile, and Peru. We assessed patients' and caregivers' beliefs about the causes of schizophrenia, which were used as predictors of symptom severity and medication attitudes in linear regression analyses. Patients' scores on biological, psychosocial, and magical-religious beliefs were positively correlated with one another, indicating that these domains were not, as anticipated, "opposing". Patients with higher levels of biological and psychosocial beliefs had significantly lower levels of positive and negative symptoms; in contrast, higher levels of magical-religious beliefs were associated with increased positive symptoms and less favorable attitudes towards medications. Patients' belief systems are significant predictors of symptom severity and medication attitudes. Research is needed on the extent to which psychotherapeutic treatments for schizophrenia should bolster patients' beliefs in the biological and psychosocial domains and weaken beliefs in the magical-religious domain; this research should also attend to the ethical considerations involved in intervening on belief systems cross-culturally.

  18. Paradoxical impact of two folate receptors, FRα and RFC, in ovarian cancer: effect on cell proliferation, invasion and clinical outcome.

    PubMed

    Siu, Michelle K Y; Kong, Daniel S H; Chan, Hoi Yan; Wong, Esther S Y; Ip, Philip P C; Jiang, LiLi; Ngan, Hextan Y S; Le, Xiao-Feng; Cheung, Annie N Y

    2012-01-01

    Despite being an essential vitamin, folate has been implicated to enhance tumor growth, as evidenced by reports on overexpression of folate receptor alpha (FRα) in carcinomas. The role of another folate transporter, reduced folate carrier (RFC), is largely unknown. This study investigated the roles of folate, FRα and RFC in ovarian cancers. We demonstrated FRα mRNA and protein overexpression and reduced RFC expression in association with FRα gene amplification and RFC promoter hypermethylation, respectively. FRα overexpression was associated with tumor progression while RFC expression incurred a favorable clinical outcome. Such reciprocal expression pattern was also observed in ovarian cancer cell lines. Folate was shown to promote cancer cell proliferation, migration and invasion in vitro, and down-regulate E-cadherin expression. This effect was blocked after either stable knockdown of FRα or ectopic overexpression of RFC. This hitherto unreported phenomenon suggests that, RFC can serve as a balancing partner of FRα and confer a protective effect in patients with high FRα-expressing ovarian carcinomas, as evidenced by their prolonged overall and disease-free survivals. In conclusion, we report on the paradoxical impact of FRα (putative oncogenic) and RFC (putative tumor suppressive) in human malignancies. FRα and RFC may potentially be explored as therapeutic target or prognostic marker respectively. We recommend caution and additional research on folate supplements in cancer patients.

  19. 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

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

    PubMed

    Lin, Chia-Der; Lin, Blossom Yen-Ju; Lin, Cheng-Chieh; Lee, Cheng-Chun

    2015-01-01

    Introduction Mentorship has been noted as critical to medical students adapting to clinical training in the medical workplace. A lack of infrastructure in a mentoring program might deter relationship building between mentors and mentees. This study assessed the effect of a redesigned clinical mentoring program from the perspective of clerks. The objective was to assess the benefits of the redesigned program and identify potential improvements. Methods A redesigned clinical mentoring program was launched in a medical center according to previous theoretical and practical studies on clinical training workplaces, including the elements of mentor qualifications, positive and active enhancers for mentor-mentee relationship building, the timing of mentoring performance evaluation, and financial and professional incentives. A four-wave web survey was conducted, comprising one evaluation of the former mentoring program and three evaluations of the redesigned clinical mentoring program. Sixty-four fifth-year medical students in clerkships who responded to the first wave and to at least two of the three following waves were included in the study. A structured and validated questionnaire encompassing 15 items on mentor performance and the personal characteristics of the clerks was used. Mixed linear models were developed for repeated measurements and to adjust for personal characteristics. Results The results revealed that the redesigned mentoring program improved the mentors' performance over time for most evaluated items regarding professional development and personal support provided to the mentees. Conclusions Our findings serve as an improved framework for the role of the institution and demonstrate how institutional policies, programs, and structures can shape a clinical mentoring program. We recommend the adoption of mentorship schemes for other cohorts of medical students and for different learning and training stages involved in becoming a physician.

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

    PubMed

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

    2013-06-01

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

  2. Favorable outcome of patients with acute myeloid leukemia harboring a low-allelic burden FLT3-ITD mutation and concomitant NPM1 mutation: relevance to post-remission therapy.

    PubMed

    Pratcorona, Marta; Brunet, Salut; Nomdedéu, Josep; Ribera, Josep Maria; Tormo, Mar; Duarte, Rafael; Escoda, Lourdes; Guàrdia, Ramon; Queipo de Llano, M Paz; Salamero, Olga; Bargay, Joan; Pedro, Carmen; Martí, Josep Maria; Torrebadell, Montserrat; Díaz-Beyá, Marina; Camós, Mireia; Colomer, Dolors; Hoyos, Montserrat; Sierra, Jorge; Esteve, Jordi

    2013-04-04

    Risk associated to FLT3 internal tandem duplication (FLT3-ITD) in patients with acute myeloid leukemia (AML) may depend on mutational burden and its interaction with other mutations. We analyzed the effect of FLT3-ITD/FLT3 wild-type (FLT3wt) ratio depending on NPM1 mutation (NPM1mut) in 303 patients with intermediate-risk cytogenetics AML treated with intensive chemotherapy. Among NPM1mut patients, FLT3wt and low ratio (<0.5) subgroups showed similar overall survival, relapse risk, and leukemia-free survival, whereas high ratio (≥0.5) patients had a worse outcome. In NPM1wt AML, FLT3-ITD subgroups showed a comparable outcome, with higher risk of relapse and shortened overall survival than FLT3wt patients. Allogeneic stem cell transplantation in CR1 was associated with a reduced relapse risk in all molecular subgroups with the exception of NPM1mut AML with absent or low ratio FLT3-ITD. In conclusion, effect of FLT3 burden is modulated by NPM1 mutation, especially in patients with a low ratio.

  3. Gamma Knife Radiosurgery for Skull Base Meningiomas: Long-Term Radiologic and Clinical Outcome

    SciTech Connect

    Han, Jung Ho; Kim, Dong Gyu Chung, Hyun-Tai; Park, Chul-Kee; Paek, Sun Ha; Kim, Chae-Yong; Jung, Hee-Won

    2008-12-01

    Purpose: To analyze the long-term outcomes in patients with skull base meningiomas (SBMNGs) treated with Gamma Knife radiosurgery (GKRS). Methods and Materials: Of the 98 consecutive patients with SBMNGs treated with GKRS between 1998 and 2002, 63 were followed up for more than 48 months. The mean ({+-}SD) age of the patients was 50 {+-} 12 years, the mean tumor volume was 6.5 cm{sup 3} (range, 0.5-18.4 cm{sup 3}), the mean marginal dose was 12.6 Gy (range, 7.0-20.0 Gy), and the mean follow-up duration was 77 {+-} 18 months. The mean number of shots was 13.7 {+-} 3.8. The tumor volume was decreased at the last follow-up in 28 patients (44.4%) and increased in 6 (9.6%). The actuarial tumor control rate was 90.2% at 5 years. No notable prognostic factor related to tumor control was identified. Ten patients (15.9%) with a cranial neuropathy showed unfavorable outcomes. The rate of improvement in patients with a cranial neuropathy was 45.1%. Age >70 years was likely correlated with an unfavorable outcome in patients with cranial neuropathy (odds ratio = 0.027; p = 0.025; 95% confidence interval 0.001-0.632). Cavernous sinus location was significantly associated with improvement of a cranial neuropathy (odds ratio = 7.314; p = 0.007; 95% confidence interval 1.707-31.34). Conclusions: Gamma Knife radiosurgery is an effective modality for the treatment of SBMNGs and provides favorable outcomes in patients with cranial neuropathy, even in the long-term follow-up period. However, radiosurgery for patients with no or only mild symptoms should be performed cautiously because neither complication rate is low enough to be negligible, especially in elderly patients. A cranial neuropathy by MNGs involving the cavernous sinus seems to have a higher chance of improvement after radiosurgery than other SBMNGs.

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

    PubMed

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

    2014-12-26

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

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

    PubMed

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

    2015-03-01

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

  6. 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

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

    PubMed

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

    2008-10-01

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

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

    PubMed Central

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

    2016-01-01

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

  9. NODAL DIFFUSE LARGE B-CELL LYMPHOMAS IN CHILDREN AND ADOLESCENTS: IMMUNOHISTOCHEMICAL EXPRESSION PATTERNS AND C-MYC TRANSLOCATION IN RELATION TO CLINICAL OUTCOME

    PubMed Central

    Gualco, Gabriela; Weiss, Lawrence M.; Harrington, William J.; Bacchi, Carlos E.

    2009-01-01

    Diffuse large B-cell lymphoma (DLBCL) is a very infrequent neoplasm in the pediatric age group; therefore there are very few studies on the immunophenotype or genetics of these cases. We studied a series of 16 patients with nodal DLBCL occurring in patients between 10 and 18 years of age. The cases were classified according to the 2008 World Health Organization classification criteria, with application of immunohistochemistry for the detection of CD10, BCL-6 and MUM1 proteins to divide the lymphomas into germinal center and non-germinal center types. In addition, TCL1, BCL-2 expression, and the Ki-67 proliferation index were evaluated by immunohistochemistry, and c-MYC and BCL-2 translocations were evaluated by FISH. All these parameters were correlated with clinical features and outcome. Our study revealed that centroblastic morphology and the germinal center type of DLBCL are more prevalent in these young patients (63%), with 37% containing a c-MYC translocation. Only one case showed a BCL-2 translocation, reflecting a double-hit case with features intermediate between DLBCL and Burkitt lymphoma. We found a higher frequency of BCL-2 expression than previously reported, with no direct influence on the outcome of the disease in univariate or multivariate analysis. The expression of TCL1 has not been specifically studied in nodal pediatric DLBCL before; we found a 31% incidence of TCL1 expression. MUM1 expression was observed in 44% of the cases and these positive cases showed a significant negative impact on clinical outcome. TCL1 is directly and significantly associated with the presence of c-MYC and a high proliferative index. The germinal center and non-germinal center subtypes showed significant differences for both overall survival and disease-free interval. C-MYC translocation was found in 37% of patients, and had a favorable impact on clinical outcome. We conclude that nodal pediatric and adolescent DLBCL are mainly of the germinal center type, with a

  10. Current Clinical Trials in Dry AMD and the Definition of Appropriate Clinical Outcome Measures.

    PubMed

    Yehoshua, Zohar; Rosenfeld, Philip J; Albini, Thomas A

    2011-05-01

    Currently, there is no proven drug treatment for dry age-related macular degeneration (AMD). Several different treatment strategies are being investigated, including complement inhibition, neuroprotection, and visual cycle inhibitors, and novel clinical trial endpoints are being explored. Studies have identified genetic predispositions for dry AMD associated with complement dysfunction. Consequently, complement-based therapeutic treatment modalities are promising.

  11. 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…

  12. Rational use of intensity-modulated radiation therapy: the importance of clinical outcome.

    PubMed

    De Neve, Wilfried; De Gersem, Werner; Madani, Indira

    2012-01-01

    During the last 2 decades, intensity-modulated radiation therapy (IMRT) became a standard technique despite its drawbacks of volume delineation, planning, robustness of delivery, challenging quality assurance, and cost as compared with non-IMRT. The theoretic advantages of IMRT dose distributions are generally accepted, but the clinical advantages remain debatable because of the lack of clinical assessment of the effort that is required to overshadow the disadvantages. Rational IMRT use requires a positive advantage/drawback balance. Only 5 randomized clinical trials (RCTs), 3 in the breast and 2 in the head and neck, which compare IMRT with non-IMRT (2-dimensional technique in four fifths of the trials), have been published (as of March 2011), and all had toxicity as the primary endpoint. More than 50 clinical trials compared results of IMRT-treated patients with a non-IMRT group, mostly historical controls. RCTs systematically showed a lower toxicity in IMRT-treated patients, and the non-RCTs confirmed these findings. Toxicity reduction, counterbalancing the drawbacks of IMRT, was convincing for breast and head and neck IMRT. For other tumor sites, the arguments favoring IMRT are weaker because of the inability to control bias outside the randomized setting. For anticancer efficacy endpoints, like survival, disease-specific survival, or locoregional control, the balance between advantages and drawbacks is fraught with uncertainties because of the absence of robust clinical data.

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

    PubMed Central

    Bond, Bryan M.; Kinslow, Christopher

    2015-01-01

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

  14. Can the fall in serum FSH during coasting in IVF/ICSI predict clinical outcomes?

    PubMed

    Datta, Adrija Kumar; Zosmer, Ariel; Tozer, Amanda; Sabatini, Luca; Davis, Colin; Al-Shawaf, Talha

    2012-05-01

    This retrospective cohort study determined whether the total falls in serum FSH and oestradiol concentrations from start to end of coasting in IVF/intracytoplasmic sperm injection could predict clinical outcomes. Ninety-nine cycles, with gonadotrophin-releasing hormone-agonist down-regulation where coasting with serial serum oestradiol and FSH monitoring was adopted due to risk of severe ovarian hyperstimulation syndrome, were consecutively included. The primary clinical outcome was live-birth rate (LBR); other outcomes measured were number of oocytes retrieved and fertilization, implantation and clinical pregnancy rates. LBR for FSH fall>10 IU/l compared with 5-10 and<5 IU/l were 45.4% versus 22.0% and 25.0%, respectively. Mean serum FSH fall was similar with and without live birth (8.4 ± 6.2 versus 7.3 ± 5.0 IU/l) as were mean oestradiol and FSH concentrations on HCG administration, oestradiol fall, percentage fall in FSH/oestradiol and duration of coasting. None of the variables efficiently predicted live birth on regression analysis. The AUC of FSH fall was 0.53 at 11.0 IU/l. Basal FSH, starting and total gonadotrophin dose and duration of coasting were positively correlated with FSH fall. A potentially clinically important association between live birth and FSH fall during coasting was apparent, which requires further evaluation. The purpose of this retrospective cohort study was to determine whether the magnitude of fall in the serum FSH and oestradiol concentrations from start to end of coasting in IVF/intracytoplasmic sperm injection cycles could predict the clinical outcomes. Gonadotrophin-releasing hormone-agonist down-regulated cycles (n=99), where coasting with serial serum oestradiol and FSH monitoring was adopted due to risk of ovarian hyperstimulation, were consecutively included. Live birth was the primary clinical outcome measured; number of oocytes retrieved and fertilization, implantation and clinical pregnancy rates were the other outcomes

  15. 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

  16. 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.

  17. Associations between the schizophrenia susceptibility gene ZNF804A and clinical outcomes in psychosis

    PubMed Central

    Wickramasinghe, A; Tulloch, A D; Hayes, R D; Chang, C-K; Broadbent, M; Di Forti, M; Murray, R M; Iyegbe, C; Stewart, R

    2015-01-01

    We sought to test the hypothesis that the rs1344706 A allele will be associated with worse clinical outcome in first-episode psychosis. A data linkage was set up between a large systematic study of first-episode psychosis and an electronic health-record case register at the South London and Maudsley NHS Foundation Trust—a large provider of secondary mental-health care. A sample of 291 patients, who presented with a first psychotic episode (ICD10 diagnoses F20–29 or F30–33) and in whom the rs1344706 genotype had been assayed, were followed to examine the duration of mental-health in-patient care during the 2 years following first service contact, as a primary outcome. Secondary outcome measures were whether or not an in-patient episode occurred and the number of in-patient episodes during this period. A strong association was found between the number of rs1344706 A alleles and the cumulative duration of mental-health in-patient stay over the 2 years since initial presentation. In the 84.2% who experienced an in-patient episode during this period, the mean duration of admission was an additional 38 days for each A allele increment. Therefore, in addition to its potential role as a risk factor for psychosis, the ZNF804A rs1344706 A allele is associated with worse clinical outcome. PMID:26670283

  18. Clinical features and pregnancy outcome in antiphospholipid syndrome patients with history of severe pregnancy complications.

    PubMed

    Matsuki, Yuko; Atsumi, Tatsuya; Yamaguchi, Koushi; Hisano, Michi; Arata, Naoko; Oku, Kenji; Watanabe, Noriyoshi; Sago, Haruhiko; Takasaki, Yoshinari; Murashima, Atsuko

    2015-03-01

    Abstract Objective. To clarify the clinical significance of antiphospholipid antibody (aPL) profile in patients with obstetric antiphospholipid syndrome (APS). Methods. Clinical records of 13 pregnant patients (15 pregnancies) with obstetrical APS were reviewed over 10 years. Patients who met the Sapporo Criteria fully were studied, whereas those with only early pregnancy loss were excluded. In addition to classical aPL: lupus anticoagulant (LA), anticardiolipin antibody (aCL), and anti-β2-glycoprotein I (aβ2GPI); phosphatidylserine-dependent anti-prothrombin antibody (aPS/PT) and kininogen-dependent anti-phosphatidylethanolamine antibody (aPE) were also examined in each case. Results. Cases were divided into two groups according to patient response to standard treatment: good and poor outcome groups. All cases with poor outcome presented LA, with IgG aβ2GPI and IgG aPS/PT were also frequently observed. IgG aPE did not correlate with pregnancy outcome. Conclusion. aPL profile may predict pregnancy outcome in patients with this subset of obstetric APS.

  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. 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

  1. 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

  2. Achieving quality and fiscal outcomes in patient care: the clinical mentor care delivery model.

    PubMed

    Burritt, Joan E; Wallace, Patricia; Steckel, Cynthia; Hunter, Anita

    2007-12-01

    Contemporary patient care requires sophisticated clinical judgment and reasoning in all nurses. However, the level of development regarding these abilities varies within a staff. Traditional care models lack the structure and process to close the expertise gap creating potential patient safety risks. In an innovative model, senior, experienced nurses were relieved of direct patient care assignments to oversee nursing care delivery. Evaluation of the model showed significant impact on quality and fiscal outcomes.

  3. The role of glutamine in intensive care unit patients: mechanisms of action and clinical outcome.

    PubMed

    Coëffier, Moïse; Déchelotte, Pierre

    2005-02-01

    Patients in the intensive care unit are at high risk of glutamine depletion and subsequent complications. Several controlled studies and a meta-analysis have concluded that glutamine supplementation has beneficial effects on the clinical outcome of critically ill and surgical patients. These results may be explained by glutamine's influences on the inflammatory response, oxidative stress, cell protection, and the gut barrier. In addition, glutamine may also improve glucose metabolism by reducing insulin resistance.

  4. 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

  5. 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%.

  6. Predictive value of XPG rs2296147T>C polymorphism on clinical outcomes of cancer patients

    PubMed Central

    Wang, Yuhan; Han, Yingying; Weng, Qiang; Yuan, Zhengrong

    2016-01-01

    The Xeroderma pigmentosum complementation group G (XPG) rs2296147T>C polymorphism is suspected to associate with the clinical outcomes of cancer patients. However, the results are inconsistent. This meta-analysis aimed to evaluate the reliable predictive value of XPG rs2296147T>C polymorphism on clinical outcomes of cancer patients. A total of 11 eligible studies were enrolled in this meta-analysis. Our results indicated that the cancer patients with TT and CT genotypes were significantly associated with better respond rates when compared with the CC genotype (TT versus (vs.) CC: odds ratio (OR) = 2.05, 95% confidence intervals (CIs), 1.32-3.20, P = 0.002; TT+CT vs. CC: OR= 1.57, 95% CI, 1.14-2.17, P = 0.005). The TT genotype and/or T allele might be associated with higher survival time for cancer patients than the CC genotype and/or C allele. The cumulative meta-analyses showed an apparent beneficial objective response of TT genotype on cancer patients. In conclusion, this meta-analysis suggests that the XPG rs2296147T>C polymorphism is associated with the clinical outcomes of cancer patients. The XPG rs2296147T>C polymorphism might be a predictive factor of prognosis in cancers patients and contribute to individual treatment in the future. PMID:27588464

  7. Clinical Features, Etiology, and Outcomes of Community-Acquired Pneumonia in Patients With Diabetes Mellitus

    PubMed Central

    Di Yacovo, Silvana; Garcia-Vidal, Carolina; Viasus, Diego; Adamuz, Jordi; Oriol, Isabel; Gili, Francesca; Vilarrasa, Núria; García-Somoza, M. Dolors; Dorca, Jordi; Carratalà, Jordi

    2013-01-01

    Abstract We performed an observational analysis of a prospective cohort of immunocompetent hospitalized adults with community-acquired pneumonia (CAP) to determine the epidemiology, clinical features, and outcomes of pneumonia in patients with diabetes mellitus (DM). We also analyzed the risk factors for mortality and the impact of statins and other cardiovascular drugs on outcomes. Of 2407 CAP episodes, 516 (21.4%) occurred in patients with DM; 483 (97%) had type 2 diabetes, 197 (40%) were on insulin treatment, and 119 (23.9%) had end-organ damage related to DM. Patients with DM had different clinical features compared to the other patients. They were less likely to have acute onset, cough, purulent sputum, and pleural chest pain. No differences in etiology were found between study groups. Patients with DM had more inhospital acute metabolic complications, although the case-fatality rate was similar between the groups. Independent risk factors for mortality in patients with DM were advanced age, bacteremia, septic shock, and gram-negative pneumonia. Patients with end-organ damage related to DM had more inhospital cardiac events and a higher early case-fatality rate than did the overall population. The use of statins and other cardiovascular drugs was not associated with better CAP outcomes in patients with DM. In conclusion, CAP in patients with DM presents different clinical features compared to the features of patients without DM. PMID:23263718

  8. Clinical Outcomes of Splenectomy in Children: Report of the Splenectomy in Congenital Hemolytic Anemia (SICHA) Registry

    PubMed Central

    Rice, Henry E; Englum, Brian R; Rothman, Jennifer; Leonard, Sarah; Reiter, Audra; Thornburg, Courtney; Brindle, Mary; Wright, Nicola; Heeney, Matthew M; Smithers, Charles; Brown, Rebeccah L; Kalfa, Theodosia; Langer, Jacob C; Cada, Michaela; Oldham, Keith T; Scott, J Paul; St. Peter, Shawn; Sharma, Mukta; Davidoff, Andrew M.; Nottage, Kerri; Bernabe, Kathryn; Wilson, David B; Dutta, Sanjeev; Glader, Bertil; Crary, Shelley E; Dassinger, Melvin S; Dunbar, Levette; Islam, Saleem; Kumar, Manjusha; Rescorla, Fred; Bruch, Steve; Campbell, Andrew; Austin, Mary; Sidonio, Robert; Blakely, Martin L

    2014-01-01

    The outcomes of children with congenital hemolytic anemia (CHA) undergoing total splenectomy (TS) or partial splenectomy (PS) remain unclear. In this study, we collected data from 100 children with CHA who underwent TS or PS from 2005–2013 at 16 sites in the Splenectomy in Congenital Hemolytic Anemia (SICHA) consortium using a patient registry. We analyzed demographics and baseline clinical status, operative details, and outcomes at 4, 24, and 52 weeks after surgery. Results were summarized as hematologic outcomes, short-term adverse events (AEs) (≤ 30 days after surgery), and long-term AEs (31–365 days after surgery). For children with hereditary spherocytosis, after surgery there was an increase in hemoglobin (baseline 10.1 ± 1.8 gm/dl, 52 week 12.8 ± 1.6 gm/dl; mean ± SD), decrease in reticulocyte and bilirubin as well as control of symptoms. Children with sickle cell disease had control of clinical symptoms after surgery, but had no change in hematologic parameters. There was an 11% rate of short-term AEs and 11% rate of long-term AEs. As we accumulate more subjects and longer follow-up, use of a patient registry should enhance our capacity for clinical trials and engage all stakeholders in the decision-making process. PMID:25382665

  9. Pre-operative clinical and instrumental factors as antireflux surgery outcome predictors

    PubMed Central

    Tolone, Salvatore; Gualtieri, Giorgia; Savarino, Edoardo; Frazzoni, Marzio; de Bortoli, Nicola; Furnari, Manuele; Casalino, Giuseppina; Parisi, Simona; Savarino, Vincenzo; Docimo, Ludovico

    2016-01-01

    Gastroesophageal reflux disease (GERD) is nowadays a highly prevalent, chronic condition, with 10% to 30% of Western populations affected by weekly symptoms. Many patients with mild reflux symptoms are treated adequately with lifestyle modifications, dietary changes, and low-dose proton pump inhibitors (PPIs). For those with refractory GERD poorly controlled with daily PPIs, numerous treatment options exist. Fundoplication is currently the most commonly performed antireflux operation for management of GERD. Outcomes described in current literature following laparoscopic fundoplication indicate that it is highly effective for treatment of GERD; early clinical studies demonstrate relief of symptoms in approximately 85%-90% of patients. However it is still unclear which factors, clinical or instrumental, are able to predict a good outcome after surgery. Virtually all demographic, esophagogastric junction anatomic conditions, as well as instrumental (such as presence of esophagitis at endoscopy, or motility patterns determined by esophageal high resolution manometry or reflux patterns determined by means of pH/impedance-pH monitoring) and clinical features (such as typical or atypical symptoms presence) of patients undergoing laparoscopic fundoplication for GERD can be factors associated with symptomatic relief. With this in mind, we sought to review studies that identified the factors that predict outcome after laparoscopic total fundoplication. PMID:27933133

  10. Pre-operative clinical and instrumental factors as antireflux surgery outcome predictors.

    PubMed

    Tolone, Salvatore; Gualtieri, Giorgia; Savarino, Edoardo; Frazzoni, Marzio; de Bortoli, Nicola; Furnari, Manuele; Casalino, Giuseppina; Parisi, Simona; Savarino, Vincenzo; Docimo, Ludovico

    2016-11-27

    Gastroesophageal reflux disease (GERD) is nowadays a highly prevalent, chronic condition, with 10% to 30% of Western populations affected by weekly symptoms. Many patients with mild reflux symptoms are treated adequately with lifestyle modifications, dietary changes, and low-dose proton pump inhibitors (PPIs). For those with refractory GERD poorly controlled with daily PPIs, numerous treatment options exist. Fundoplication is currently the most commonly performed antireflux operation for management of GERD. Outcomes described in current literature following laparoscopic fundoplication indicate that it is highly effective for treatment of GERD; early clinical studies demonstrate relief of symptoms in approximately 85%-90% of patients. However it is still unclear which factors, clinical or instrumental, are able to predict a good outcome after surgery. Virtually all demographic, esophagogastric junction anatomic conditions, as well as instrumental (such as presence of esophagitis at endoscopy, or motility patterns determined by esophageal high resolution manometry or reflux patterns determined by means of pH/impedance-pH monitoring) and clinical features (such as typical or atypical symptoms presence) of patients undergoing laparoscopic fundoplication for GERD can be factors associated with symptomatic relief. With this in mind, we sought to review studies that identified the factors that predict outcome after laparoscopic total fundoplication.

  11. Comparison of long-term clinical outcomes between sirolimus- and paclitaxel-eluting stents in real-world clinical practice.

    PubMed

    Naito, Ryo; Miyauchi, Katsumi; Konishi, Hirokazu; Tsuboi, Shuta; Ogita, Manabu; Kasai, Takatoshi; Tamura, Hiroshi; Okazaki, Shinya; Daida, Hiroyuki

    2015-11-01

    Advances in percutaneous coronary intervention (PCI) have improved the outcomes of patients with coronary artery diseases. The advent of drug-eluting stents (DES) has dramatically reduced the rate of revascularization. The first-generation DES has yielded the main role of PCI to the second-generation DES; however, many patients had been implanted with the first-generation DES, sirolimus-eluting stents (SES) and paclitaxel-eluting stents (PES). Therefore, it is of importance to detect the long-term clinical outcomes in patients who underwent PCI with SES or PES. We analyzed data from our PCI cohort who underwent PCI with first-generation DES at Juntendo University Hospital between August 2004 and June 2010. The index procedure was analyzed when patients underwent multiple PCIs. Patients who were implanted with both SES and PES were excluded from this study. The study ended on December 31, 2011. The primary outcome was a composite of all-cause mortality and acute coronary syndrome (ACS). The secondary outcome was the rate of target lesion revascularization (TLR) and stent thrombosis. We analyzed data from 861 consecutive patients who underwent implantation of SES or PES. The median follow-up period was 1671 days (interquartile range 1081 and 2105). Kaplan-Meier curves for the primary endpoint did not significantly differ between the two groups (p = 0.8). The incidence of stent thrombosis was 1.4 and 1.8 per 1,000 person-years in the SES and PES groups, respectively (p = 0.9). The rate of TLR was significantly lower in the SES, than the PES group (12.6 and 38.3 per 1,000 person-years, p = 0.03). The rate of TLR was lower in the group treated with SES than PES, but the primary outcome comprising all-cause mortality and ACS was comparable between the two groups.

  12. Improving PTSD Outcomes in OIF/OEF Returnees: A Randomized Clinical Trial of Hydrocortisone Augmentation of Prolonged Exposure Therapy

    DTIC Science & Technology

    2012-08-01

    Award Number: W81XWH-10-2-0072 TITLE: Improving PTSD Outcomes in OIF/OEF Returnees: A Randomized Clinical Trial of Hydrocortisone...SUBTITLE 5a. CONTRACT NUMBER Improving PTSD Outcomes in OIF/OEF Returnees: A Randomized Clinical Trial of Hydrocortisone Augmentation of Prolonged... clinical trial of Prolonged Exposure (PE) with glucocorticoid augmentation (with 30 mg Cortef) or placebo. (0 to 4 months)  Train new study personnel in

  13. Factors influencing polymerase chain reaction outcomes in patients with clinically suspected ocular tuberculosis

    PubMed Central

    2014-01-01

    Background Polymerase chain reaction (PCR) assay can be a useful method for definitive diagnosis in paucibacillary infections such as ocular tuberculosis (TB). In this study, we have evaluated factors affecting PCR outcomes in patients with clinically suspected ocular TB. Patients with clinically suspected ocular TB were investigated by PCR of aqueous or vitreous samples. Three control groups were also tested: group 1 included culture-proven non-tuberculous endophthalmitis, group 2 culture-negative non-tuberculous endophthalmitis, and group 3 patients undergoing surgery for uncomplicated cataract. PCR targeted one or more of following targets: IS6110, MPB64, and protein b genes of Mycobacterium tuberculosis complex. Multiple regression analysis (5% level of significance) was done to evaluate the associations between positive PCR outcome and laterality of disease, tuberculin skin test (TST)/interferon-gamma release assay (IGRA), chest radiography, and type of sample (aqueous or vitreous). The main outcome measures were positive PCR by one or more gene targets, and factors influencing positive PCR outcomes. Results All 114 samples were tested for MPB64, 110 for protein b, and 88 for IS6110. MPB64 was positive in 70.2% (n = 80) of tested samples, protein b in 40.0% (n = 44), and IS6110 in only 9.1% (n = 8). DNA sequencing of amplicons from four randomly chosen PCR reactions showed homology for M. tuberculosis complex. Of the 80 PCR-positive patients, 71 completed a full course of antitubercular therapy, of which 65 patients (91.5%) had complete resolution of inflammation at final follow-up. Among controls, 12.5% (3 out of 24) in group 1 and 18.7% (6 out of 32) in group 2 also tested positive by PCR. No PCR-positive outcome was observed in control group 3 (n = 25). Multiple regression analysis revealed significant association of positive PCR outcome with bilateral presentation, but not with a positive TST/IGRA, chest radiography, or type of sample

  14. 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

  15. Clinical outcomes of antimicrobial lock solutions used in a treatment modality: a retrospective case series analysis

    PubMed Central

    Bookstaver, P Brandon; Gerrald, Katherine R; Moran, Robert R

    2010-01-01

    Background Antimicrobial lock therapy (ALT) may be considered as adjunctive therapy in the treatment of catheter-related bloodstream infections (CRBSI) when catheter removal is not a favorable option. Objective To evaluate the outcomes associated with ALT as adjunctive treatment of CRBSI. Methods This was a 24-month retrospective case series analysis evaluating patients treated for more than 24 hours with ALT. The primary outcome was blood culture sterilization for 30 days posttherapy. The impact of ALT duration and time to initiation on central venous catheter (CVC) salvage were evaluated. Logistic regression modeled the association between ALT and sterilization rates, with a prespecified level of significance (α) of 0.1. Results Twenty-six cases were included in data analysis. Patients included ranged from 5 months to 82 years of age; 77% of patients were receiving total parenteral nutrition or chemotherapy. The majority of patients received vancomycin, daptomycin, or gentamicin combined with heparin in a lock solution. Blood culture sterilization was achieved in 69.2% of cases, and sterilization plus CVC retention was achieved in 11 cases (42.3%). Longer durations of ALT (≥9 days) were significantly correlated with blood culture sterilization (odds ratio = 1.367, P = 0.077). Conclusion ALT used as an adjunct to systemic therapy for adequate duration in CRBSI can achieve CVC sterilization and retainment without subsequent infectious complications. PMID:22291495

  16. Doublet chemotherapy with cisplatin and pemetrexed is associated with a favorable outcome in patients with advanced non-squamous non-small-cell lung cancer who are eligible for bevacizumab and maintenance therapy

    PubMed Central

    Nakashima, Kazuhisa; Murakami, Haruyasu; Omori, Shota; Wakuda, Kazushige; Ono, Akira; Kenmotsu, Hirotsugu; Naito, Tateaki; Endo, Masahiro; Takahashi, Toshiaki

    2016-01-01

    The previous AVAPERL trial demonstrated that induction therapy with first-line cisplatin (CDDP), pemetrexed (PEM) and bevacizumab (BEV), followed by continuation maintenance therapy with PEM+BEV, improved the progression-free survival (PFS) and overall survival (OS) compared with BEV alone (median PFS, 10.2 vs. 6.6 months and median OS, 19.8 vs. 15.9 months, respectively) in patients with advanced non-squamous non-small-cell lung cancer (non-Sq NSCLC). However, those findings were based on selected patients who were eligible for BEV and maintenance therapy. To assess the efficacy of CDDP+PEM as first-line therapy in selected patients depending on their eligibility for BEV and maintenance therapy, consecutive patients with non-Sq NSCLC who received first-line chemotherapy with CDDP+PEM at the Shizuoka Cancer Center (Shizuoka, Japan) between July, 2009 and December, 2013 were retrospectively reviewed. A total of 160 patients were assessed, including 92 who were eligible and 68 who were not eligible for BEV treatment. In the BEV-eligible group, CDDP+PEM treatment followed by maintenance PEM exhibited significantly superior efficacy compared with that in the BEV-ineligible group (median PFS, 5.8 vs. 4.8 months, respectively, P=0.013; and median OS, 21.3 vs. 12.6 months, respectively, P=0.0025). In the BEV-eligible group, 60 patients were suitable for maintenance therapy with PEM (group A) and 32 patients were unsuitable (group B). In the BEV-ineligible group, 31 patients were suitable for maintenance therapy with PEM (group C) and 37 patients were unsuitable (group D). In group A, the median PFS and OS were 6.9 and 31.8 months, respectively, compared with 2.4 and 10.5 months in group B, 6.1 and 18.5 months in group C, and 2.8 and 7.7 months in group D. The PFS and OS in group A were significantly better compared with those in the other groups. Thus, the PFS and OS with CDDP+PEM were favorable among patients with advanced non-Sq NSCLC who were eligible for BEV and

  17. Doublet chemotherapy with cisplatin and pemetrexed is associated with a favorable outcome in patients with advanced non-squamous non-small-cell lung cancer who are eligible for bevacizumab and maintenance therapy.

    PubMed

    Nakashima, Kazuhisa; Murakami, Haruyasu; Omori, Shota; Wakuda, Kazushige; Ono, Akira; Kenmotsu, Hirotsugu; Naito, Tateaki; Endo, Masahiro; Takahashi, Toshiaki

    2016-11-01

    The previous AVAPERL trial demonstrated that induction therapy with first-line cisplatin (CDDP), pemetrexed (PEM) and bevacizumab (BEV), followed by continuation maintenance therapy with PEM+BEV, improved the progression-free survival (PFS) and overall survival (OS) compared with BEV alone (median PFS, 10.2 vs. 6.6 months and median OS, 19.8 vs. 15.9 months, respectively) in patients with advanced non-squamous non-small-cell lung cancer (non-Sq NSCLC). However, those findings were based on selected patients who were eligible for BEV and maintenance therapy. To assess the efficacy of CDDP+PEM as first-line therapy in selected patients depending on their eligibility for BEV and maintenance therapy, consecutive patients with non-Sq NSCLC who received first-line chemotherapy with CDDP+PEM at the Shizuoka Cancer Center (Shizuoka, Japan) between July, 2009 and December, 2013 were retrospectively reviewed. A total of 160 patients were assessed, including 92 who were eligible and 68 who were not eligible for BEV treatment. In the BEV-eligible group, CDDP+PEM treatment followed by maintenance PEM exhibited significantly superior efficacy compared with that in the BEV-ineligible group (median PFS, 5.8 vs. 4.8 months, respectively, P=0.013; and median OS, 21.3 vs. 12.6 months, respectively, P=0.0025). In the BEV-eligible group, 60 patients were suitable for maintenance therapy with PEM (group A) and 32 patients were unsuitable (group B). In the BEV-ineligible group, 31 patients were suitable for maintenance therapy with PEM (group C) and 37 patients were unsuitable (group D). In group A, the median PFS and OS were 6.9 and 31.8 months, respectively, compared with 2.4 and 10.5 months in group B, 6.1 and 18.5 months in group C, and 2.8 and 7.7 months in group D. The PFS and OS in group A were significantly better compared with those in the other groups. Thus, the PFS and OS with CDDP+PEM were favorable among patients with advanced non-Sq NSCLC who were eligible for BEV and

  18. Comparison between Radiological and Clinical Outcomes of Laminoplasties with Titanium Miniplates for Cervical Myelopathy

    PubMed Central

    Park, Jong-Hwa; Lee, Ho-Jin; Shin, Byung-Kon

    2016-01-01

    Background Laminoplasty is a surgical procedure frequently performed for cervical myelopathy. We investigated correlations between changes in the anteroposterior diameter (APD) of the spinal canal, spinal canal area (SCA), and laminar angle (LA) and clinical outcomes of laminoplasty. Methods Of the 204 cervical myelopathy patients who underwent laminoplasty from July 2010 to May 2015, 49 patients who were evaluated with pre- and postoperative computed tomography of the cervical vertebrae were included. The average age of the patients was 60.4 years (range, 31 to 82 years), and the average duration of follow-up was 31.6 months (range, 9 to 68 months). Changes in the APD and SCA were measured at the middle of the vertebral body. Changes in LA were measured where both pedicles were clearly visible. Clinical outcomes were assessed using the Japanese Orthopaedic Association (JOA) score and visual analog scale score for pain preoperatively (1 day before surgery) and postoperatively (last outpatient visit) and examining postoperative complications. Results The APD showed an average of 54.7% increase from 11.5 to 17.8 mm. The SCA showed an average of 57.7% increase from 225.9 to 356.3 mm2. The LA increased from 34.2° preoperatively to 71.9° postoperatively. The JOA score increased from an average of 9.1 preoperatively to 13.4 postoperatively. Three patients were found to have hinge fractures during surgery. Postoperative complications, including two cases of C5 palsy, were recorded. The correlation coefficient between the LA change and JOA score improvement was −0.449 (p < 0.05). Patients with a < 33° (25%) increase in the LA showed the most significant clinical improvement. Conclusions Patients with a < 33° (25%) change in the LA after laminoplasty with a titanium miniplate showed the most significant clinical improvement. Thus, LA changes can be useful in predicting the clinical outcome of laminoplasty. PMID:27904722

  19. Rotator Cuff Repair in Patients over 75 Years of Age: Clinical Outcome and Repair Integrity

    PubMed Central

    Park, Jung Gwan; Cho, Nam Su; Song, Jong Hoon; Baek, Jong Hun; Jeong, Ho Yeon

    2016-01-01

    Background Some studies have shown significant functional improvement after rotator cuff (RC) repair in elderly patients. However, few studies have reported the healing potential of RC tears in elderly patients. Methods Twenty-five patients aged ≥ 75 years who underwent RC repair were enrolled. The mean age at the time of surgery was 78.3 years (range, 75 to 88 years) while the mean follow-up was 36.3 months (range, 18 to 114 months). We evaluated clinical and structural outcomes after RC repair in the retear and healed groups. Results Of 25 patients, 16 (64%) had healed RC lesions and 9 (36%) had retorn cuff lesions. The retear rate increased significantly with increasing initial tear size (small to medium, 13%; large, 60%; massive, 80%; p = 0.024) but not with increasing age (p = 0.072). The mean visual analog scale (VAS), University of California Los Angeles (UCLA), and Constant scores significantly improved from 5.2, 15.8, and 49.3 preoperatively to 1.4, 31.1, and 71.9 in the healed group and from 6.0, 14.4, and 39.5 preoperatively to 2.4, 28.3, and 63.6 in the retear group at the final follow-up (p < 0.05, respectively). There were no significant differences in clinical outcomes between the 2 groups at the final follow-up. Retear was significantly correlated with initial tear size (p = 0.001; odds ratio [OR], 2.771; 95% confidence interval [CI], 1.394 to 5.509 for large to massive tears) (p = 0.001; OR, 0.183; 95% CI, 0.048 to 0.692 for small to medium tears). Conclusions There were significant improvements in clinical outcomes after RC repair in patients ≥ 75 years. Structural integrity after cuff repair did not affect the final clinical outcome. Even in elderly patients aged ≥ 75 years, healing of repaired RC can be expected in cases of small to medium tears. Although the retear rate was relatively high for large to massive tears, clinical outcomes still showed significant improvement. PMID:27904725

  20. Survival and other clinical outcomes of maintenance hemodialysis patients in Taiwan: a 5-year multicenter follow-up study.

    PubMed

    Chen, Huan-Sheng; Cheng, Chun-Ting; Hou, Chun-Cheng; Liou, Hung-Hsiang; Lim, Paik-Seong

    2014-10-01

    The increasing aging and diabetes mellitus (DM) patients in dialysis population make the quality maintenance of dialysis an imperative issue. Recently, an increasing number of dialysis centers were run by private dialysis providers, many of which apply quality assurance programs and performance management systems to dialysis care. We studied patients in dialysis facilities in Taiwan run by a private chain to see clinical outcomes of centers operating under these systemic strategies. Hemodialysis patients from January 1, 2008 to December 31, 2012 in 25 dialysis facilities in Taiwan, which received the management and consultation from a dialysis service provider, NephroCare (NC), were included. Data pivotal to quality of dialysis were analyzed. During a 5-year interval, 5161 hemodialysis patients were included. For volume control, the proportion of patients with weight gain ≥4.5% decreases from 41.7% to 30.2%. Mean Kt/V is 1.74 ± 0.28. Mean albumin level is 3.92 ± 0.38 g/dL. Patients with phosphate <5.5 mg/dL is up to 71.8%. The mean hemoglobin level is 10.70 ± 1.40 g/dL. More than 80% of patients have adequate iron status. Further, 73% of patients use native arteriovenous fistula. Hospitalization-free survival rate was 56% at the fifth year. Patient survival rate at the fifth year was 66.4%. Overall clinical performances were maintained very stable in NC facilities from this temporal data analysis. The hospitalization and survival rate also compare favorably with those reported internationally. These results warrant further studies to justify the application of this kind of quality assurance programs and performance management systems in dialysis care.

  1. Effects of a curricular revision on learner outcomes in veterinary clinical pathology.

    PubMed

    Hollinger, Charlotte; Libarkin, Julie C; Stickle, Julia E; Hauptman, Joe G; Henry, Rebecca; Scott, Michael A

    2013-01-01

    A mixed-methods evaluation was conducted to study learner attitudes and knowledge about clinical pathology across a curricular change that instituted a stand-alone clinical pathology course in place of content within a previously integrated pathology course structure. Groups of pre- and post-change students were assessed three times across the two semesters leading up to graduation. At each time, rank-ordered and open-ended response items probed attitudes, and multiple-choice items assessed knowledge. Data about student clinical pathology performance were also collected from clinical pathology instructors and supervising clinicians. Student rank-ordered items were evaluated by factor analysis; resulting factor-scale scores, multiple-choice scores, and rank responses from study cohorts were statistically assessed between groups and within each group over time. Intraclass correlations were calculated for the coding of student open-ended responses, and all coded responses were compared among groups. Analysis revealed that students in the revised curriculum had greater satisfaction with their training and greater confidence in data interpretation compared to students without exposure to an independent clinical pathology course. Although differences in knowledge of clinical pathology were not detected, it was also apparent that the independent clinical pathology course filled a student-perceived curricular need without raising criticisms related to diminished integration with anatomic pathology. Secondary study outcomes included formative feedback for course improvement, evidence of clerkship efficacy, and baseline data for further studies.

  2. The CONSORT Patient-Reported Outcome (PRO) extension: implications for clinical trials and practice

    PubMed Central

    2013-01-01

    To inform clinical guidelines and patient care we need high quality evidence on the relative benefits and harms of intervention. Patient reported outcome (PRO) data from clinical trials can “empower patients to make decisions based on their values” and “level the playing field between physician and patient”. While clinicians have a good understanding of the concept of health-related quality of life and other PROs, evidence suggests that many do not feel comfortable in using the data from trials to inform discussions with patients and clinical practice. This may in part reflect concerns over the integrity of the data and difficulties in interpreting the results arising from poor reporting. The new CONSORT PRO extension aims to improve the reporting of PROs in trials to facilitate the use of results to inform clinical practice and health policy. While the CONSORT PRO extension is an important first step in the process, we need broader engagement with the guidance to facilitate optimal reporting and maximize use of PRO data in a clinical setting. Endorsement by journal editors, authors and peer reviewers are crucial steps. Improved design, implementation and transparent reporting of PROs in clinical trials are necessary to provide high quality evidence to inform evidence synthesis and clinical practice guidelines. PMID:24168680

  3. Reverse shoulder arthroplasty. Part 1: Systematic review of clinical and functional outcomes

    PubMed Central

    Samitier, Gonzalo; Alentorn-Geli, Eduard; Torrens, Carlos; Wright, Thomas W.

    2015-01-01

    Many factors influence the outcomes of reverse shoulder arthroplasty (RSA). The purpose of this study was to compare the clinical and functional outcomes of RSA depending on the surgical approach, type of prosthesis, and indication for surgery through a comprehensive, systematic review. A literature search was conducted (1985 to June 2012) using PubMed, CINAHL, EBSCO–SPORTDiscus, and Cochrane Central Register of Controlled Trials. Levels I–IV evidence, in-vivo human studies (written in English with minimum of 2 years of follow-up and sample size of 10 patients) reporting clinical and/or functional outcomes after RSA were included. The outcomes were analyzed depending on the surgical approach, type of prosthesis (with medialized or lateralized center of rotation), or indication for surgery. A total of 35 studies were included involving 2049 patients (mean [SD] percentage of females, age, and follow-up of 71.6% [13.4], 71.5 years [3.7], and 43.1 months [18.8], respectively). Studies using deltopectoral approach with lateralized prostheses demonstrated greater improvement in external rotation compared with medialized prostheses with the same approach (mean 22.9° and 5°, respectively). In general, RSA for cuff tear arthropathy demonstrated higher improvements in Constant and American Shoulder and Elbow Society scores, and range of motion compared with revision of anatomic prosthesis, failed rotator cuff repair, and fracture sequelae. Lateralized prostheses provided more improvement in external rotation compared to medialized prostheses. Indications of RSA for cuff tear arthropathy demonstrated higher improvements in the outcomes compared with other indications. RSA demonstrated high patient's satisfaction regardless of the type of prosthesis or indication for surgery. Level of Evidence: Level IV. PMID:25709242

  4. 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

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

    PubMed Central

    Choi, Wook Jin

    2016-01-01

    The incidence and mortality of gastric cancer have been steadily decreased over the past few decades. However, gastric cancer is still one of the leading causes of cancer deaths across many regions of the world, particularly in Asian countries. In previous studies, nutrition has been considered one of significant risk factors in gastric cancer patients. Especially, malnourished patients are at greater risk of adverse clinical outcomes (e.g., longer hospital stay) and higher incidence of complications (e.g., wound/infectious complications) compared to well-nourished patients. Malnutrition is commonly found in advanced gastric cancer patients due to poor absorption of essential nutrients after surgery. Therefore, nutritional support protocols, such as early oral and enternal feeding, have been proposed in many studies, to improve unfavorable clinical outcomes and to reduce complications due to delayed application of oral nutritional support or parental feeding. Also, the supplied with enternal immune-enriched diet had more benefits in improving clinical outcomes and fewer complications compared to a group supplied with control formula. Using nutritional screening tools, such as nutritional risk index (NRI) and nutritional risk screening (NRS 2002), malnourished patients showed higher incidence of complications and lower survival rates than non-malnourished patients. However, a long-term nutritional intervention, such as nutritional counseling, was not effective in the patients. Therefore, early assessment of nutritional status in patients using a proper nutritional screening tool is suggested to prevent malnutrition and adverse health outcomes. Further studies with numerous ethnic groups may provide stronger scientific evidences in association between nutritional care and recovery from surgery in patients with gastric cancer. PMID:27152296

  6. Asymptomatic Mild Hyperperfusion for the Prediction of Clinical Outcome in Postoperative Patients After Subarachnoid Hemorrhage

    PubMed Central

    Nakagawa, Manabu; Mutoh, Tatsushi; Takenaka, Shunsuke; Mutoh, Tomoko; Totsune, Tomoko; Taki, Yasuyuki; Ishikawa, Tatsuya

    2017-01-01

    Background Delayed cerebral ischemia (DCI) is one of the main causes of poor outcomes after subarachnoid hemorrhage (SAH). The early identification of DCI by noninvasive imaging modalities would provide valuable information of therapeutic intervention for improving the patient outcomes. We aimed to describe the clinical features of cerebral blood flow (CBF) data obtained from the single-photon emission computed tomography (SPECT) during the risk period for DCI after SAH. Material/Methods Clinical data from 94 SAH patients who underwent surgical clipping of anterior circulation aneurysms were reviewed retrospectively. 99mTc-HMPAO SPECT images were visually and semiquantitatively analyzed on days 7 and 14 after SAH. Results In all cases, the areas of hypoperfusion were found in the middle cerebral artery territories. By contrast, the areas of mild hyperperfusion were always detected on the surgical side, the prevalence which increased from days 7 (n=28; 30%) to 14 (n=48; 51%) without neurological defects. Univariate analysis revealed that the hyperperfusion on day 14 had a significant relationship with functional outcome at 3 months (P=0.04). Multivariate analysis including age, clinical SAH grade, DCI, and hyperperfusion on day 14 showed that DCI (P=0.004; odds ratio [OR], 0.10; 95% confidence interval [CI], 0.02–0.48) and hyperperfusion on day 14 (P=0.002; OR, 2.44; 95% CI, 1.40–4.29) were independently associated with functional outcome at 3 months. Conclusions Delayed mild hyperperfusion around the surgical site can predict good prognosis after SAH, although it may hinder the CBF diagnosis of focal ischemia attributable to DCI. PMID:28093563

  7. The Association of Visual Impairment With Clinical Outcomes in Hemodialysis Patients.

    PubMed

    Hong, Yu Ah; Kim, Suk Young; Kim, Su-Hyun; Kim, Young Ok; Jin, Dong Chan; Song, Ho Chul; Choi, Euy Jin; Kim, Yong-Lim; Kim, Yon-Su; Kang, Shin-Wook; Kim, Nam-Ho; Yang, Chul Woo; Kim, Yong Kyun

    2016-05-01

    Visual impairment limits people's ability to perform daily tasks and affects their quality of life. We evaluated the impact of visual impairment on clinical outcomes in hemodialysis (HD) patients.HD patients were selected from the Clinical Research Center registry a prospective cohort study on dialysis patients in Korea. Visual impairment was defined as difficulty in daily life due to decreased visual acuity or blindness. The primary outcome was all-cause mortality and the secondary outcomes were cardiovascular and infection-related hospitalization.A total of 3250 patients were included. Seven hundred thirty (22.5%) of the enrolled patients had visual impairment. The median follow-up period was 30 months. The Kaplan-Meier curve and log-rank test showed that all-cause mortality rates (P < 0.001) as well as cardiovascular and infection-related hospitalization rates (P < 0.001 and P < 0.001) were significantly higher in patients with visual impairment than in patients without visual impairment. In the multivariable analysis, visual impairment had significant predictive power for all-cause mortality (Hazard ratio [HR], 1.77, 95% confidence interval [CI], 1.21-2.61, P = 0.004) and cardiovascular hospitalization (HR 1.45 [1.00-1.90], P = 0.008) after adjusting for confounding variables. Of these 3250 patients, 634 patients from each group were matched by propensity scores. In the propensity score matched analysis, patients with visual impairment had independently significant associations with increased all-cause mortality (HR 1.69 [1.12-2.54], P = 0.01) and cardiovascular hospitalization (HR 1.48 [1.08-2.02], P = 0.01) compared with patients without visual impairment after adjustment for confounding variables.Our data demonstrated that visual impairment was an independent risk factor for clinical adverse outcomes in HD patients.

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

    PubMed

    Choi, Wook Jin; Kim, Jeongseon

    2016-04-01

    The incidence and mortality of gastric cancer have been steadily decreased over the past few decades. However, gastric cancer is still one of the leading causes of cancer deaths across many regions of the world, particularly in Asian countries. In previous studies, nutrition has been considered one of significant risk factors in gastric cancer patients. Especially, malnourished patients are at greater risk of adverse clinical outcomes (e.g., longer hospital stay) and higher incidence of complications (e.g., wound/infectious complications) compared to well-nourished patients. Malnutrition is commonly found in advanced gastric cancer patients due to poor absorption of essential nutrients after surgery. Therefore, nutritional support protocols, such as early oral and enternal feeding, have been proposed in many studies, to improve unfavorable clinical outcomes and to reduce complications due to delayed application of oral nutritional support or parental feeding. Also, the supplied with enternal immune-enriched diet had more benefits in improving clinical outcomes and fewer complications compared to a group supplied with control formula. Using nutritional screening tools, such as nutritional risk index (NRI) and nutritional risk screening (NRS 2002), malnourished patients showed higher incidence of complications and lower survival rates than non-malnourished patients. However, a long-term nutritional intervention, such as nutritional counseling, was not effective in the patients. Therefore, early assessment of nutritional status in patients using a proper nutritional screening tool is suggested to prevent malnutrition and adverse health outcomes. Further studies with numerous ethnic groups may provide stronger scientific evidences in association between nutritional care and recovery from surgery in patients with gastric cancer.

  9. Peripheral Artery Disease and Chronic Kidney Disease: Clinical Synergy to Improve Outcomes

    PubMed Central

    Garimella, Pranav S.; Hirsch, Alan T.

    2014-01-01

    Persons with chronic kidney disease (CKD) are at a higher risk of developing peripheral artery disease (PAD) and its adverse health outcomes than individuals in the general population who have normal renal function. Classic atherosclerosis risk factors care (e.g., age, smoking, diabetes, hypertension and hyperlipidemia) are common in CKD patients, but CKD also imposes additional unique risk factors that promote arterial disease (e.g., chronic inflammation, hypoalbuminemia and a pro-calcific state). Current nephrology clinical practice is adversely impacted by PAD diagnostic challenges, the complexities of managing two serious comorbid diseases, delayed vascular specialist referral, and slow PAD treatment initiation in CKD patients. Persons with CKD are less likely to be provided recommended ‘optimal’ PAD care. The knowledge that both limb and mortality outcomes are significantly worse in CKD patients, especially those on dialysis, is not a biologic fact, but can serve as a care delivery call to action. Nephrologists can facilitate positive change. This manuscript proposes that patients with PAD and CKD be strategically co-managed by care teams that encompass the skills to create and use evidence-based care pathways. This proposed collaborative multidisciplinary approach will include vascular medicine specialists, nephrologists, wound specialists and mid-level providers. Just as clinical care quality metrics have served as the base for ESRD and acute MI quality improvement, it is time that such quality outcomes metrics be initiated for the large PAD-CKD population. This new system will identify and resolve key gaps in the current care model so that clinical outcomes improve within a cost-effective care frame for this vulnerable population. PMID:25443571

  10. 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.

  11. Six-month clinical outcomes after hyperopic correction with the SCHWIND AMARIS Total-Tech laser

    PubMed Central

    Arbelaez, María Clara; Vidal, Camila; Arba Mosquera, Samuel

    2011-01-01

    Purpose To evaluate postoperative clinical outcomes, and corneal High Order Aberrations, among eyes with hyperopia up to +5 D of spherical equivalent, that have undergone LASIK treatments using the SCHWIND AMARIS laser system. Methods At six-month follow-up, 100 eyes with preoperative hyperopia or hyperopic astigmatism up to +5 D of spherical equivalent were retrospectively analysed. Standard examinations, pre- and postoperative wavefront analysis with a corneal-wavefront-analyzer (OPTIKON Scout) were performed. Aberration-Free aspheric treatments were planned with Custom Ablation Manager software and ablations performed using the SCHWIND AMARIS flying-spot excimer laser system (both SCHWIND eye-tech-solutions). LASIK flaps were created using a LDV femtosecond laser (Ziemer Group) in all cases. Clinical outcomes were evaluated in terms of predictability, refractive outcome, safety, and wavefront aberration. Results At six month, 90 % of eyes achieved ≥ 20/25 UCVA and 44 % achieved ≥ 20/16 UCVA. Seventy-four percent of eyes were within ± 0.25D of spherical equivalent and 89 % within ± 0.50D, with 94 % within 0.50D of astigmatism. Mean spherical equivalent was −0.12 ± 0.51D and 0.50 ± 0.51D for the astigmatism. Fifty-two percent of eyes improved BSCVA vs. only 19 % losing lines of BSCVA. Predictability slope for refraction was 1.03 and intercept +0.01 D. On average, negative corneal spherical aberrations were significantly increased by the treatments, no other aberration terms changed from pre- to postoperative values. Conclusions LASIK for hyperopia and hyperopic astigmatism with SCHWIND AMARIS yields very satisfactory visual outcomes. Preoperative refractions were postoperatively reduced to subclinical values with no clinically relevant induction of corneal HOA.

  12. Using ClinicalTrials.gov to Supplement Information in Ophthalmology Conference Abstracts about Trial Outcomes: A Comparison Study

    PubMed Central

    Scherer, Roberta W.; Huynh, Lynn; Ervin, Ann-Margret; Dickersin, Kay

    2015-01-01

    Background Including results from unpublished randomized controlled trials (RCTs) in a systematic review may ameliorate the effect of publication bias in systematic review results. Unpublished RCTs are sometimes described in abstracts presented at conferences, included in trials registers, or both. Trial results may not be available in a trials register and abstracts describing RCT results often lack study design information. Complementary information from a trials register record may be sufficient to allow reliable inclusion of an unpublished RCT only available as an abstract in a systematic review. Methods We identified 496 abstracts describing RCTs presented at the 2007 to 2009 Association for Research in Vision and Ophthalmology (ARVO) meetings; 154 RCTs were registered in ClinicalTrials.gov. Two persons extracted verbatim primary and non-primary outcomes reported in the abstract and ClinicalTrials.gov record. We compared each abstract outcome with all ClinicalTrials.gov outcomes and coded matches as complete, partial, or no match. Results We identified 800 outcomes in 152 abstracts (95 primary [51 abstracts] and 705 [141 abstracts] non-primary outcomes). No outcomes were reported in 2 abstracts. Of 95 primary outcomes, 17 (18%) agreed completely, 53 (56%) partially, and 25 (26%) had no match with a ClinicalTrials.gov primary or non-primary outcome. Among 705 non-primary outcomes, 56 (8%) agreed completely, 205 (29%) agreed partially, and 444 (63%) had no match with a ClinicalTrials.gov primary or non-primary outcome. Among the 258 outcomes partially agreeing, we found additional information on the time when the outcome was measured more often in ClinicalTrials.gov than in the abstract (141/258 (55%) versus 55/258 (21%)). We found no association between the presence of non-matching “new” outcomes and year of registration, time to registry update, industry sponsorship, or multi-center status. Conclusion Conference abstracts may be a valuable source of

  13. 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.

  14. Blastocyst culture and cryopreservation to optimize clinical outcomes of warming cycles.

    PubMed

    Zhu, Lixia; Xi, Qingsong; Zhang, Hanwang; Li, Yufeng; Ai, Jihui; Jin, Lei

    2013-08-01

    Surplus embryos available for cryopreservation in fresh cycles are considered as having good potential for future use. However, the optimal stage of embryo cryopreservation remains unclear. In this study, 1190 patients with surplus embryos on day 3 were divided into two groups: cleavage-stage embryo cryopreservation (control group) and blastocyst cryopreservation (blastocyst group). The clinical outcomes of the subsequent warming cycles were evaluated. The proportion of cycles with blastocyst formation was 73.8% in the blastocyst group. Although in the blastocyst group, the cancellation rate of blastocyst transfer was increased due to lack of blastocysts available for cryopreservation, the blastocyst group achieved significantly higher rates of clinical pregnancy/cycle (43.2% versus 34.9%; P=0.003), pregnancy/transfer (59.5% versus 35.4%; P<0.001) and implantation (46.5% versus 22.2%; P<0.001) from the first warming cycle compared with the control group. In an embryo-number classified analysis, the clinical pregnancy rate was also higher in the blastocyst group. However, the cumulative pregnancy was similar between the two groups. Blastocyst culture as an embryo selection tool will not improve embryo viability but it will help patients to achieve pregnancy more quickly. Extended culture of surplus embryos to the blastocyst stage for cryopreservation optimizes the clinical outcomes.

  15. Client Preferences Affect Treatment Satisfaction, Completion, and Clinical Outcome: A Meta-Analysis

    PubMed Central

    Lindhiem, Oliver; Bennett, Charles B.; Trentacosta, Christopher J.; McLear, Caitlin

    2014-01-01

    We conducted a meta-analysis on the effects of client preferences on treatment satisfaction, completion, and clinical outcome. Our search of the literature resulted in 34 empirical articles describing 32 unique clinical trials that either randomized some clients to an active choice condition (shared decision making condition or choice of treatment) or assessed client preferences. Clients who were involved in shared decision making, chose a treatment condition, or otherwise received their preferred treatment evidenced higher treatment satisfaction (ESd = .34; p < .001), increased completion rates (ESOR = 1.37; ESd = .17; p < .001), and superior clinical outcome (ESd = .15; p < .0001), compared to clients who were not involved in shared decision making, did not choose a treatment condition, or otherwise did not receive their preferred treatment. Although the effect sizes are modest in magnitude, they were generally consistent across several potential moderating variables including study design (preference versus active choice), psychoeducation (informed versus uninformed), setting (inpatient versus outpatient), client diagnosis (mental health versus other), and unit of randomization (client versus provider). Our findings highlight the clinical benefit of assessing client preferences, providing treatment choices when two or more efficacious options are available, and involving clients in treatment-related decisions when treatment options are not available. PMID:25189522

  16. Combined Modality Treatment for PET-Positive Non-Hodgkin Lymphoma: Favorable Outcomes of Combined Modality Treatment for Patients With Non-Hodgkin Lymphoma and Positive Interim or Postchemotherapy FDG-PET

    SciTech Connect

    Halasz, Lia M.; Jacene, Heather A.; Catalano, Paul J.; Van den Abbeele, Annick D.; LaCasce, Ann; Mauch, Peter M.; Ng, Andrea K.

    2012-08-01

    Purpose: To evaluate outcomes of patients treated for aggressive non-Hodgkin lymphoma (NHL) with combined modality therapy based on [{sup 18}F]fluoro-2-deoxy-2-D-glucose positron emission tomography (FDG-PET) response. Methods and Materials: We studied 59 patients with aggressive NHL, who received chemotherapy and radiation therapy (RT) from 2001 to 2008. Among them, 83% of patients had stage I/II disease. Patients with B-cell lymphoma received R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone)-based chemotherapy, and 1 patient with anaplastic lymphoma kinase-negative anaplastic T-cell lymphoma received CHOP therapy. Interim and postchemotherapy FDG-PET or FDG-PET/computed tomography (CT) scans were performed for restaging. All patients received consolidated involved-field RT. Median RT dose was 36 Gy (range, 28.8-50 Gy). Progression-free survival (PFS) and local control (LC) rates were calculated with and without a negative interim or postchemotherapy FDG-PET scan. Results: Median follow-up was 46.5 months. Thirty-nine patients had negative FDG-PET results by the end of chemotherapy, including 12 patients who had a negative interim FDG-PET scan and no postchemotherapy PET. Twenty patients were FDG-PET-positive, including 7 patients with positive interim FDG-PET and no postchemotherapy FDG-PET scans. The 3-year actuarial PFS rates for patients with negative versus positive FDG-PET scans were 97% and 90%, respectively. The 3-year actuarial LC rates for patients with negative versus positive FDG-PET scans were 100% and 90%, respectively. Conclusions: Patients who had a positive interim or postchemotherapy FDG-PET had a PFS rate of 90% at 3 years after combined modality treatment, suggesting that a large proportion of these patients can be cured with consolidated RT.

  17. Do various baseline characteristics of transversus abdominis and lumbar multifidus predict clinical outcomes in nonspecific low back pain? A systematic review.

    PubMed

    Wong, Arnold Y L; Parent, Eric C; Funabashi, Martha; Stanton, Tasha R; Kawchuk, Gregory N

    2013-12-01

    Although individual reports suggest that baseline morphometry or activity of transversus abdominis or lumbar multifidus predict clinical outcome of low back pain (LBP), a related systematic review is unavailable. Therefore, this review summarized evidence regarding the predictive value of these muscular characteristics. Candidate publications were identified from 6 electronic medical databases. After review, 5 cohort studies were included. Although this review intended to encompass studies using different muscle assessment methods, all included studies coincidentally used ultrasound imaging. No research investigated the relation between static morphometry and clinical outcomes. Evidence synthesis showed limited evidence supporting poor baseline transversus abdominis contraction thickness ratio as a treatment effect modifier favoring motor control exercise. Limited evidence supported that high baseline transversus abdominis lateral slide was associated with higher pain intensity after various exercise interventions at 1-year follow-up. However, there was limited evidence for the absence of relation between the contraction thickness ratio of transversus abdominis or anticipatory onset of lateral abdominal muscles at baseline and the short- or long-term LBP intensity after exercise interventions. There was conflicting evidence for a relation between baseline percent thickness change of lumbar multifidus during contraction and the clinical outcomes of patients after various conservative treatments. Given study heterogeneity, the small number of included studies and the inability of conventional greyscale B-mode ultrasound imaging to measure muscle activity, our findings should be interpreted with caution. Further large-scale prospective studies that use appropriate technology (ie, electromyography to assess muscle activity) should be conducted to investigate the predictive value of morphometry or activity of these muscles with respect to LBP-related outcomes measures.

  18. The pharmacology and clinical outcomes of amphetamines to treat ADHD: does composition matter?

    PubMed

    Hodgkins, Paul; Shaw, Monica; McCarthy, Suzanne; Sallee, Floyd R

    2012-03-01

    Attention-deficit hyperactivity disorder (ADHD) treatment options include pharmacological and nonpharmacological approaches. In North America, psychostimulants (amphetamine and methylphenidate) are considered first-line pharmacological treatments for patients (children, adolescents and adults) with ADHD. However, in the UK, National Institute for Health and Clinical Excellence (NICE) guidelines have placed short-acting d-amphetamine as a third-line treatment option due to a lack of contemporary, published clinical trials on its efficacy and the concerns from clinical and patient experts regarding the potential for increased abuse and/or misuse compared with methylphenidate. These guidelines do not account for some of the more recent amphetamine products that have been developed to alleviate some of these concerns, but that are not currently approved in the UK or other European countries. The purpose of this review is to describe the pharmacology and clinical efficacy of various amphetamine compositions, as well as to explore the apparent differences in these compositions and their associated risks and benefits. A PubMed literature search was conducted to investigate amphetamine pharmacology, clinical efficacy and safety and ADHD outcomes in the published literature from 1980 through March 2011. Search terms included the keywords 'ADHD' or 'ADD' or 'hyperkinetic disorder' and any of the following keywords combined with 'or': 'amphetamine', 'dexamphetamine', 'mixed amphetamine salts', 'lisdexamfetamine' and 'methamphetamine'. The search included English-language primary research articles and review articles but excluded editorial articles and commentaries. The literature search resulted in 330 articles. Pertinent articles relating to amphetamine pharmacology, compositions, clinical efficacy and safety, effectiveness and tolerability, ADHD outcomes and abuse liability were included in this review. The different delivery profiles of amphetamine compositions result in

  19. Effects of clinical practice environments on clinical teacher and nursing student outcomes.

    PubMed

    Babenko-Mould, Yolanda; Iwasiw, Carroll L; Andrusyszyn, Mary-Anne; Laschinger, Heather K S; Weston, Wayne

    2012-04-01

    The purpose of this study was to use a cross-sectional survey design, with an integrated theoretical perspective, to examine clinical teachers' (n = 64) and nursing students' (n = 352) empowerment, teachers' and students' perceptions of teachers' use of empowering teaching behaviors, students' perceptions of nurses' practice behaviors, and students' confidence for practice in acute care settings. In this study, teachers and students were moderately empowered. Teachers reported using a high level of empowering teaching behaviors, which corresponded with students' perceptions of teachers' use of such behaviors. Teachers' empowerment predicted 21% of their use of empowering teaching behaviors. Students reported nurses as using a high level of professional practice behaviors. Students felt confident for professional nursing practice. The findings have implications for practice contexts related to empowering teaching-learning environments and self-efficacy.

  20. Cartilage repair: synthetics and scaffolds: basic science, surgical techniques, and clinical outcomes.

    PubMed

    Kerker, Jordan T; Leo, Andrew J; Sgaglione, Nicholas A

    2008-12-01

    Symptomatic articular cartilage lesions have gained attention and clinical interest in recent years and can be difficult to treat. Historically, various biologic surgical treatment options have yielded inconsistent results because of the inferior biomechanical properties associated with a variable healing response. Improving technology and surgical advances has generated considerable research in cartilage resurfacing and optimizing hyaline tissue restoration. Biologic innovation and tissue engineering in cartilage repair have used matrix scaffolds, autologous and allogenic chondrocytes, cartilage grafts, growth factors, stem cells, and genetic engineering. Numerous evolving technologies and surgical approaches have been introduced into the clinical setting. This review will discuss the basic science, surgical techniques, and clinical outcomes of novel synthetic materials and scaffolds for articular cartilage repair.

  1. Borderline personality disorder: patterns of self-harm, reported childhood trauma and clinical outcome

    PubMed Central

    Milner, Rebecca; Gavin, Victoria; Levita, Liat

    2015-01-01

    Summary Consecutive admissions of 214 women with borderline personality disorder were investigated for patterns of specific forms of self-harm and reported developmental experiences. Systematic examination of clinical notes found that 75% had previously reported a history of childhood sexual abuse. These women were more likely to self-harm, and in specific ways that may reflect their past experiences. Despite this, treatment within a dialectical behaviour therapy-informed therapeutic community leads to relatively greater clinical gains than for those without a reported sexual abuse trauma history. Notably, greater behavioural and self-reported distress and dissociation were not found to predict poor clinical outcome. Declaration of interest None. Copyright and usage © The Royal College of Psychiatrists 2015. This is an open access article distributed under the terms of the Creative Commons Non-Commercial, No Derivatives (CC BY-NC-ND) licence. PMID:27703718

  2. Clinical terminology support for a national ambulatory practice outcomes research network.

    PubMed

    Ricciardi, Thomas N; Lieberman, Michael I; Kahn, Michael G; Masarie, F E

    2005-01-01

    The Medical Quality Improvement Consortium (MQIC) is a nationwide collaboration of 74 healthcare delivery systems, consisting of 3755 clinicians, who contribute de-identified clinical data from the same commercial electronic medical record (EMR) for quality reporting, outcomes research and clinical research in public health and practice benchmarking. Despite the existence of a common, centrally-managed, shared terminology for core concepts (medications, problem lists, observation names), a substantial "back-end" information management process is required to ensure terminology and data harmonization for creating multi-facility clinically-acceptable queries and comparable results. We describe the information architecture created to support terminology harmonization across this data-sharing consortium and discuss the implications for large scale data sharing envisioned by proponents for the national adoption of ambulatory EMR systems.

  3. Clinical differentiation and outcome evaluation in vegetative and minimally conscious state patients: the neurophysiological approach

    PubMed Central

    De Salvo, Simona; Bramanti, Placido; Marino, Silvia

    2012-01-01

    Summary The neurophysiological approach to patients with disorders of consciousness allows recording of both central and peripheral nervous system electrical activities and provides a functional assessment. Data obtained using this approach can supplement information from clinical neurological examination, but also from the use of morphological neuroimaging techniques: computed tomography and magnetic resonance imaging. Neurophysiological techniques, such as electroencephalography (EEG), evoked potentials, transcranial magnetic stimulation, and EEG in association with functional magnetic resonance imaging, allow monitoring of clinical conditions and can help in the formulation of a prognosis. The aim of this review is to describe the main neurophysiological techniques used in disorders of consciousness to evaluate residual cerebral function, to provide information on the neuronal dysfunction for outcome evaluation, and to differentiate clinically between the vegetative and minimally conscious states. PMID:23402676

  4. Clinical Features and Visual Outcomes of Optic Neuritis in Chinese Children

    PubMed Central

    Zhou, Huanfen; Xu, Quangang; Tan, Shaoying; Zhao, Shuo; Yang, Mo; Peng, Chunxia

    2016-01-01

    Purpose. Although optic neuritis (ON) in children is relatively common, visual outcomes and factors associated with the condition have not been well documented. The aim of this study was to evaluate the clinical features and visual outcomes of ON in Chinese children. Methods. Patients with a first episode of ON at a tertiary neuroophthalmic centre in China were assessed and followed up for at least three months. Visual outcomes and clinical, laboratory, and neuroimaging findings were reviewed. In patients with bilateral ON, only the eyes with worse visual acuity (VA) at presentation were used for statistical analysis. Results. Seventy-six children (76 eyes) with a first episode of ON were included. The mean age was 11.8 years, 60.5% were females, and 48.7% had bilateral involvement. The children were followed up for an average of 18.5 months (age range, 3–48 months). Vision loss at presentation was severe, with VA < 20/200 in 37 eyes (48.7%). At the final visit, 3 (3.9%) eyes had VA of at least 20/20, and 41 (53.9%) eyes had VA of at least 20/40. The final VA in 35 eyes (46.1%) was worse than 20/40. Children aged ≤ 10 years had better predicted visual outcomes when compared to children over 10 years (odds ratio = 2.73, 95% confidential interval: 1.05–7.07, and P = 0.039). The other features of this cohort, such as sex, experienced bilateral attack, VA at presentation, presence of optic disc edema, systemic diseases, magnetic resonance imaging (MRI) findings, and aquaporin-4 (AQP-4) antibody status, were not significantly correlated with the final visual outcome. Conclusion. The data revealed the clinical characteristics and visual outcomes of ON in Chinese children. ON in children was associated with severe vision loss and relatively good visual recovery. The age at onset could predict the final visual function. PMID:27725883

  5. EUCLID: an outcome analysis tool for high-dimensional clinical studies

    NASA Astrophysics Data System (ADS)

    Gayou, Olivier; Parda, David S.; Miften, Moyed

    2007-03-01

    Treatment management decisions in three-dimensional conformal radiation therapy (3DCRT) and intensity-modulated radiation therapy (IMRT) are usually made based on the dose distributions in the target and surrounding normal tissue. These decisions may include, for example, the choice of one treatment over another and the level of tumour dose escalation. Furthermore, biological predictors such as tumour control probability (TCP) and normal tissue complication probability (NTCP), whose parameters available in the literature are only population-based estimates, are often used to assess and compare plans. However, a number of other clinical, biological and physiological factors also affect the outcome of radiotherapy treatment and are often not considered in the treatment planning and evaluation process. A statistical outcome analysis tool, EUCLID, for direct use by radiation oncologists and medical physicists was developed. The tool builds a mathematical model to predict an outcome probability based on a large number of clinical, biological, physiological and dosimetric factors. EUCLID can first analyse a large set of patients, such as from a clinical trial, to derive regression correlation coefficients between these factors and a given outcome. It can then apply such a model to an individual patient at the time of treatment to derive the probability of that outcome, allowing the physician to individualize the treatment based on medical evidence that encompasses a wide range of factors. The software's flexibility allows the clinicians to explore several avenues to select the best predictors of a given outcome. Its link to record-and-verify systems and data spreadsheets allows for a rapid and practical data collection and manipulation. A wide range of statistical information about the study population, including demographics and correlations between different factors, is available. A large number of one- and two-dimensional plots, histograms and survival curves allow

  6. EUCLID: an outcome analysis tool for high-dimensional clinical studies.

    PubMed

    Gayou, Olivier; Parda, David S; Miften, Moyed

    2007-03-21

    Treatment management decisions in three-dimensional conformal radiation therapy (3DCRT) and intensity-modulated radiation therapy (IMRT) are usually made based on the dose distributions in the target and surrounding normal tissue. These decisions may include, for example, the choice of one treatment over another and the level of tumour dose escalation. Furthermore, biological predictors such as tumour control probability (TCP) and normal tissue complication probability (NTCP), whose parameters available in the literature are only population-based estimates, are often used to assess and compare plans. However, a number of other clinical, biological and physiological factors also affect the outcome of radiotherapy treatment and are often not considered in the treatment planning and evaluation process. A statistical outcome analysis tool, EUCLID, for direct use by radiation oncologists and medical physicists was developed. The tool builds a mathematical model to predict an outcome probability based on a large number of clinical, biological, physiological and dosimetric factors. EUCLID can first analyse a large set of patients, such as from a clinical trial, to derive regression correlation coefficients between these factors and a given outcome. It can then apply such a model to an individual patient at the time of treatment to derive the probability of that outcome, allowing the physician to individualize the treatment based on medical evidence that encompasses a wide range of factors. The software's flexibility allows the clinicians to explore several avenues to select the best predictors of a given outcome. Its link to record-and-verify systems and data spreadsheets allows for a rapid and practical data collection and manipulation. A wide range of statistical information about the study population, including demographics and correlations between different factors, is available. A large number of one- and two-dimensional plots, histograms and survival curves allow

  7. Clinical presentations and outcomes of bile duct loss caused by drugs and herbal and dietary supplements.

    PubMed

    Bonkovsky, Herbert L; Kleiner, David E; Gu, Jiezhun; Odin, Joseph A; Russo, Mark W; Navarro, Victor M; Fontana, Robert J; Ghabril, Marwan S; Barnhart, Huiman; Hoofnagle, Jay H

    2017-04-01

    Bile duct loss during the course of drug-induced liver injury is uncommon, but can be an indication of vanishing bile duct syndrome (VBDS). In this work, we assess the frequency, causes, clinical features, and outcomes of cases of drug-induced liver injury with histologically proven bile duct loss. All cases of drug-induced liver injury enrolled into a prospective database over a 10-year period that had undergone liver biopsies (n = 363) were scored for the presence of bile duct loss and assessed for clinical and laboratory features, causes, and outcomes. Twenty-six of the 363 patients (7%) with drug-, herbal-, or dietary-supplement-associated liver injury had bile duct loss on liver biopsy, which was moderate to severe (<50% of portal areas with bile ducts) in 14 and mild (50%-75%) in 12. The presenting clinical features of the 26 cases varied, but the most common clinical pattern was a severe cholestatic hepatitis. The implicated agents included amoxicillin/clavulanate (n = 3), temozolomide (n = 3), various herbal products (n = 3), azithromycin (n = 2), and 15 other medications or dietary supplements. Compared to those without, those with bile duct loss were more likely to develop chronic liver injury (94% vs. 47%), which was usually cholestatic and sometimes severe. Five patients died and 2 others underwent liver transplantation for progressive cholestasis despite treatment with corticosteroids and ursodiol. The most predictive factor of poor outcome was the degree of bile duct loss on liver biopsy.

  8. Impact of vancomycin faecal concentrations on clinical and microbiological outcomes in Clostridium difficile infection.

    PubMed

    Thabit, Abrar K; Nicolau, David P

    2015-08-01

    To assess the impact of faecal vancomycin concentrations on clinical and microbiological outcomes in patients with Clostridium difficile infection (CDI) and whether these concentrations vary with stool consistency and frequency, faecal concentrations of vancomycin were measured in stools collected at various times from patients initiated on 125mg every 6h (q6h) for 10 days. Stool consistency and frequency were determined over the course of therapy. Clinical and microbiological outcomes were assessed during therapy, at the end of therapy (EOT) and during a 19-38-day follow-up visit. Faecal vancomycin concentrations in 55 stool samples from 15 patients ranged from 175-6299μg/g at Days 3-5 of therapy (midpoint), 17-5277μg/g at EOT and 0-70μg/g at follow-up. Clinical cure or failure at EOT and at follow-up was not dependent on vancomycin concentrations measured at the midpoint (P=0.72) or at EOT (P=0.76). Likewise, concentrations at EOT and at follow-up did not predict colonisation at follow-up (P=0.85 and 0.71, respectively). Faecal vancomycin concentrations during the course of therapy (Days 3-5) did not differ with either stool consistency or frequency (P=0.94 and 0.16, respectively). However, after completion of therapy, patients with more frequent stools showed higher concentrations than patients with less frequent stools (P=0.04). Oral vancomycin 125mg q6h led to faecal concentrations that did not predict clinical outcomes of CDI in terms of cure or gut colonisation and did not vary with stool consistency and frequency.

  9. Anatomic Anterolateral Ligament Reconstruction Improves Postoperative Clinical Outcomes Combined with Anatomic Anterior Cruciate Ligament Reconstruction

    PubMed Central

    Qiu, Man; Zhou, Aiguo; Zhang, Jian; Jiang, Dianming

    2016-01-01

    A significant cohort of patients is plagued by postoperative rotational instability after the anatomic anterior cruciate ligament (ACL) reconstruction surgery. Anatomic anterolateral ligament (ALL) reconstruction was performed in this study with the aim to assess the clinical role of ALL in knee’s stability and joint functions. Sixty patients were recruited and divided into three groups to perform the operations of anatomic single-bundle ACL reconstruction, anatomic double-bundle ACL reconstruction, and anatomic single-bundle ACL reconstruction + anterolateral ligament reconstruction, respectively. And then postoperative knee’s stability and joint functions were evaluated to compare the clinical outcomes among the three different kind of operations. The postoperative knee’s stability and joint functions of the anatomic double-bundle ACL reconstruction group and the anatomic single-bundle ACL reconstruction + ALL reconstruction group were better than the anatomic single-bundle ACL reconstruction group. No significant difference was observed between the anatomic double-bundle ACL reconstruction group and the anatomic single-bundle ACL reconstruction + ALL reconstruction group. The anatomic anterolateral ligament reconstruction could improve the clinical outcomes after patients performed the anatomic single-bundle anterior cruciate ligament reconstruction. This indicates that the anterolateral ligament plays a crucial role in knee’s stability and joint function, especially the rotational stability. Key points Anatomic anterolateral ligament reconstruction combined with anatomic anterior cruciate ligament reconstruction was performed to treat the patients with ACL rupture. Compared to the anatomic single-bundle ACL reconstruction group, the anatomic single-bundle ACL reconstruction + ALL reconstruction group achieve a better clinical outcomes. The results suggest that the anterolateral ligament plays a crucial role in knee’s stability and joint function

  10. Effect of RAAS blockers on adverse clinical outcomes in high CVD risk subjects with atrial fibrillation

    PubMed Central

    Chaugai, Sandip; Sherpa, Lhamo Yanchang; Sepehry, Amir A.; Arima, Hisatomi; Wang, Dao Wen

    2016-01-01

    Abstract Recent studies have demonstrated that atrial fibrillation significantly increases the risk of adverse clinical outcomes in high cardiovascular disease risk subjects. Application of renin–angiotensin–aldosterone system blockers for prevention of recurrence of atrial fibrillation and adverse clinical outcomes in subjects with atrial fibrillation is a theoretically appealing concept. However, results of clinical trials evaluating the effect of renin–angiotensin–aldosterone blockers on adverse clinical outcomes in high cardiovascular disease risk subjects with atrial fibrillation remain inconclusive. A pooled study of 6 randomized controlled trials assessing the efficacy of renin–angiotensin–aldosterone blockers on subjects with atrial fibrillation was performed. A total of 6 randomized controlled trials enrolled a total of 53,510 patients followed for 1 to 5 years. RAAS blockade therapy was associated with 14% reduction in the incidence of heart failure (OR: 0.86, [95%CI: 0.76– 0.97], P=0.018) and 17% reduction in the incidence of CVE (OR: 0.83, [95%CI: 0.70–0.99], P = 0.038). The corresponding decline in absolute risk against heart failure (ARR: 1.4%, [95%CI: 0.2–2.6%], P = 0.018) and CVE (ARR: 3.5%, [95%CI: 0.0–6.9%], P = 0.045) in the AF group was much higher than the non-AF group for heart failure (ARR: 0.4%, [95%CI: 0.0–0.7%], P = 0.057) and CVE (ARR: 1.6%, [95%CI: –0.1% to 3.3%], P = 0.071). No significant effect was noted on all-cause or cardiovascular mortality, stroke, or myocardial infarction. This study suggests that RAAS blockade offers protection against heart failure and cardiovascular events in high cardiovascular disease risk subjects with atrial fibrillation. PMID:27368043

  11. 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

  12. Multiparametric magnetic resonance imaging predicts clinical outcomes in patients with chronic liver disease

    PubMed Central

    Pavlides, Michael; Banerjee, Rajarshi; Sellwood, Joanne; Kelly, Catherine J.; Robson, Matthew D.; Booth, Jonathan C.; Collier, Jane; Neubauer, Stefan; Barnes, Eleanor

    2016-01-01

    Background & Aims Multiparametric magnetic resonance (MR) imaging has been demonstrated to quantify hepatic fibrosis, iron, and steatosis. The aim of this study was to determine if MR can be used to predict negative clinical outcomes in liver disease patients. Methods Patients with chronic liver disease (n = 112) were recruited for MR imaging and data on the development of liver related clinical events were collected by medical records review. The median follow-up was 27 months. MR data were analysed blinded for the Liver Inflammation and Fibrosis score (LIF; <1, 1–1.99, 2–2.99, and ⩾3 representing normal, mild, moderate, and severe liver disease, respectively), T2∗ for liver iron content and proportion of liver fat. Baseline liver biopsy was performed in 102 patients. Results Liver disease aetiologies included non-alcoholic fatty liver disease (35%) and chronic viral hepatitis (30%). Histologically, fibrosis was mild in 54 (48%), moderate in 17 (15%), and severe in 31 (28%) patients. Overall mortality was 5%. Ten patients (11%) developed at least one liver related clinical event. The negative predictive value of LIF <2 was 100%. Two patients with LIF 2–2.99 and eight with LIF ⩾3 had a clinical event. Patients with LIF ⩾3 had a higher cumulative risk for developing clinical events, compared to those with LIF <1 (p = 0.02) and LIF 1–1.99 (p = 0.03). Cox regression analysis including all 3 variables (fat, iron, LIF) resulted in an enhanced LIF predictive value. Conclusions Non-invasive standardised multiparametric MR technology may be used to predict clinical outcomes in patients with chronic liver disease. PMID:26471505

  13. Risk Factors and Clinical Outcomes in Preterm Infants with Pulmonary Hypertension

    PubMed Central

    Collaco, Joseph M.; Dadlani, Gul H.; Nies, Melanie K.; Leshko, Jenny; Everett, Allen D.; McGrath-Morrow, Sharon A.

    2016-01-01

    Background Pulmonary hypertension (PH) is a significant cause of morbidity in preterm infants, but no screening guidelines exist. We sought to identify risk factors and clinical outcomes associated with PH in preterm infants to develop a PH risk score. Methods Retrospective analysis of two separate populations of preterm infants (NICU cohort n = 230; Clinic registry n = 580). Results 8.3% of the NICU cohort had PH after 4 weeks of age, while 14.8% of the clinic registry had PH after 2 months of age. Lower birth weights and longer initial hospitalizations were associated with PH in both populations (p<0.001 for all tests). Using adjusted logistic regression, patent ductus arteriosus (PDA) requiring ligation was associated with PH in both the NICU cohort (OR: 3.19; p = 0.024) and the clinic registry (OR: 2.67; p<0.001). Risk factors (birth weight ≤780 grams, home supplemental oxygen use, and PDA ligation) identified in the clinic registry (training dataset) were validated in the NICU cohort with 0–1 factors present were associated with ≤1.5% probability of having PH, any 2 factors with a 25% probability, and all 3 factors with a 40% probability. Conclusions Lower birth weight, PDA ligation, and respiratory support were associated with PH in both populations. A PH risk score based on clinical indicators from the training dataset predicted PH in the validation set. This risk score could help focus resources to preterm infants at higher risk for PH. Further work is needed to determine whether earlier or more aggressive management of ductal lesions could alter PH outcomes. PMID:27716811

  14. Value of symptoms to predict tilt testing outcome in patients with clinical suspicion of vasovagal syncope.

    PubMed

    Vallejo, Maite; Hermosillo, Antonio G; Márquez, Manlio F; Urquidez, Alma K; Sotomayor, Arturo; Salas, Elizabeth; Cárdenas, Manuel

    2007-07-01

    Studies to assess the value of clinical symptoms to predict the head-up tilt test (HUT) outcome in patients with suspicion of vasovagal syncope have shown controversial results. We undertook this study to compare the frequency of symptoms between subjects with and without history of syncope, its association with syncopal spells in those with a history of syncope and positive or negative HUT, and to identify clinical predictors of HUT outcome. Sixty seven subjects with a history of unexplained syncope and 26 subjects without a history of syncope were interviewed using a structured questionnaire before undergoing HUT, which was performed first in a passive phase and, if negative, was repeated with pharmacological challenge using 5 mg of sublingual isosorbide. Questionnaire included the 16 symptoms most frequently reported in previous studies. Only five symptoms were reported more frequently by subjects with history of syncope in comparison with subjects without it: visual blurring, dysesthesia, sighing dyspnea, tremor in fingers, and diaphoresis. Comparison of symptom frequency between patients with history of syncope and positive or negative HUT revealed that only two were significantly different: nausea and hot flashes. However, a detailed analysis of the data indicates that only hot flashes occurring just before the syncope were more common in those with a positive HUT. Although some symptoms were found more frequently in patients with a history of syncope than in those without it, the use of a structured questionnaire in the group of patients failed to predict the outcome of the HUT.

  15. Anterior Cruciate Ligament Reconstruction: Clinical Outcomes of Patella Tendon and Hamstring Tendon Grafts

    PubMed Central

    Gulick, Dawn T.; Yoder, Heather N.

    2002-01-01

    An injury to the ACL can result in significant functional impairment. It has been estimated that more than 100,000 new ACL injuries occur each year. Surgeons employ numerous techniques for reconstruction of the ACL. Of critical importance is the source of the graft to replace the damaged ACL. The graft choices include autografts (the patient's own tissue), allografts (donor tendon), and synthetic/prosthetic ligaments. Tissue harvest sites for autografting include the middle third of the patella tendon, the quadriceps tendon, semitendinosus tendon, gracilis tendon, iliotibial band, tensor fascia lata, and the Achilles tendon. Selection of the type of graft material is predicated upon the tissue's ability to tolerate high levels of stress. Likewise, the clinical presentation and functional outcome is related to the graft material selected. This manuscript specifically examined the patella tendon and hamstring tendon grafts. Numerous manuscripts that studied the outcomes of these graft materials were compiled to help the clinician appreciate the advantages and disadvantages of each of the graft materials. Outcome measures such as thigh circumference, knee range of motion, isokinetic strength, knee stability, pain, and vertical jump/1-leg hop were incorporated. The purpose of this manuscript was to compare and contrast the clinical presentation of patients who underwent an ACL reconstruction using the patella tendon versus the hamstring tendons. This information can be valuable to the clinician when considering the rehabilitation protocol after ACL reconstruction. PMID:24701126

  16. Endophthalmitis Caused by Enterococcus faecalis: Clinical Features, Antibiotic Sensitivities, and Outcomes

    PubMed Central

    Kuriyan, Ajay E.; Sridhar, Jayanth; Flynn, Harry W.; Smiddy, William E.; Albini, Thomas A.; Berrocal, Audina M.; Forster, Richard K.; Belin, Peter J.; Miller, Darlene

    2014-01-01

    Purpose To report the clinical features, antibiotic sensitivities, and visual acuity (VA) outcomes of endophthalmitis caused by Enterococcus faecalis. Study Design Retrospective, observational case series. Methods A consecutive case series of patients with culture-positive endophthalmitis caused by E. faecalis between January 1, 2002 and December 31, 2012 at an academic referral center. Results Of 14 patients identified, clinical settings included bleb-associated (n=8), post-cataract surgery (n=4), and post-penetrating keratoplasty (n=2). All isolates were vancomycin sensitive. When comparing isolates in the current study to isolates from 1990–2001, the minimal inhibitory concentration required to inhibit 90% of isolates (MIC 90, μg/ml) increased for ciprofloxacin (4 from 1), erythromycin (256 from 4), and penicillin (8 from 4), indicating higher levels of resistance. The MIC 90 remained the same for vancomycin (2) and linezolid (2). Presenting VA ranged from hand motion to no light perception. Initial treatment strategies were vitreous tap and intravitreal antibiotic injection (n=12) and pars plana vitrectomy with intravitreal antibiotic injection (n=2). VA outcomes were ≤ 20/400 in 13 (93%) of 14 patients. Conclusions Although all isolates were sensitive to vancomycin and linezolid, higher MIC 90s for isolates in the current study, compared to isolates from 1990 to 2001, occurred with ciprofloxacin, erythromycin, and penicillin. Despite prompt treatment, most patients had poor outcomes. PMID:25089354

  17. Impact of Supported Housing on Clinical Outcomes Analysis of a Randomized Trial Using Multiple Imputation Technique

    PubMed Central

    Cheng, An-Lin; Lin, Haiqun; Kasprow, Wesley; Rosenheck, Robert A.

    2011-01-01

    In 1992, the US Department of Housing and Urban Development (HUD) and the US Department of Veterans Affairs (VA) established the HUD-VA Supported Housing (HUD-VASH) Program to provide integrated clinical and housing services to homeless veterans with psychiatric and/or substance abuse disorders at 19 sites. At four sites, 460 subjects were randomly assigned to one of the three groups: (1) HUD-VASH, with both Section 8 vouchers and intensive case management; (2) case management only; and (3) standard VA care. A previous publication found HUD-VASH resulted in superior housing outcomes but yielded no benefits on clinical outcomes. Since many participants missed prescheduled visits during the follow-up period and follow-up rates were quite different across the groups, we reanalyzed these data using multiple imputation statistical methods to account for the missing observations. Significant benefits were found for HUD-VASH in drug and alcohol abuse outcomes that had not previously been identified. PMID:17220745

  18. Relationship between biological factors and catastrophizing and clinical outcomes for female patients with knee osteoarthritis

    PubMed Central

    Ikemoto, Tatsunori; Miyagawa, Hirofumi; Shiro, Yukiko; Arai, Young-Chang Park; Akao, Machiko; Murotani, Kenta; Ushida, Takahiro; Deie, Masataka

    2017-01-01

    AIM To investigate the correlations between clinical outcomes and biopsychological variables in female patients with knee osteoarthritis (OA). METHODS Seventy-seven patients with symptomatic knee OA were enrolled in this study. We investigated the age, body mass index (BMI), pain catastrophizing scale (PCS) and radiographic severity of bilateral knees using a Kellgren-Lawrence (K-L) grading system of the subjects. Subsequently, a multiple linear regression was conducted to determine which variables best correlated with main outcomes of knee OA, which were pain severity, moving capacity by measuring timed-up-and-go test and Japanese Knee Osteoarthritis Measure (JKOM). RESULTS We found that the significant contributor to pain severity was PCS (β = 0.555) and BMI (β = 0.239), to moving capacity was K-L grade (β = 0.520) and to PCS (β = 0.313), and to a JKOM score was PCS (β = 0.485) and K-L grade (β = 0.421), respectively. CONCLUSION The results suggest that pain catastrophizing as well as biological factors were associated with clinical outcomes in female patients with knee OA, irrespective of radiographic severity. PMID:28361021

  19. Antifungal Susceptibility Testing of Fluconazole by Flow Cytometry Correlates with Clinical Outcome

    PubMed Central

    Wenisch, Christoph; Moore, Caroline B.; Krause, Robert; Presterl, Elisabeth; Pichna, Peter; Denning, David W.

    2001-01-01

    Susceptibility testing of fungi by flow cytometry (also called fluorescence-activated cell sorting [FACS]) using vital staining with FUN-1 showed a good correlation with the standard M27-A procedure for assessing MICs. In this study we determined MICs for blood culture isolates from patients with candidemia by NCCLS M27-A and FACS methods and correlated the clinical outcome of these patients with in vitro antifungal resistance test results. A total of 24 patients with candidemia for whom one or more blood cultures were positive for a Candida sp. were included. Susceptibility testing was performed by NCCLS M27-A and FACS methods. The correlation of MICs (NCCLS M27-A and FACS) and clinical outcome was calculated. In 83% of the cases, the MICs of fluconazole determined by FACS were within 1 dilution of the MICs determined by the NCCLS M27-A method. For proposed susceptibility breakpoints, there was 100% agreement between the M27-A and FACS methods. In the FACS assay, a fluconazole MIC of <1 μg/ml was associated with cure (P < 0.001) whereas an MIC of ≥1 μg/ml was associated with death (P < 0.001). The M27-A-derived fluconazole MICs did not correlate with outcome (P = 1 and P = 0.133). PMID:11427554

  20. Polyvictimization: Latent profiles and mental health outcomes in a clinical sample of adolescents

    PubMed Central

    Adams, Zachary W.; Moreland, Angela; Cohen, Joseph R.; Lee, Robert C.; Hanson, Rochelle F.; Danielson, Carla Kmett; Self-Brown, Shannon; Briggs, Ernestine C.

    2015-01-01

    Objective Exposure to multiple traumatic events (polyvictimization) is a reliable predictor of deleterious health outcomes and risk behaviors in adolescence. The current study extends the literature on the prevalence and consequences of adolescent trauma exposure by (a) empirically identifying and characterizing trauma exposure profiles in a large, ethnically diverse, multi-site, clinical sample of adolescents, and (b) evaluating relations among identified profiles with demographic characteristics and clinical correlates. Method Data from the National Child Traumatic Stress Network Core Data Set were used to identify and characterize victimization profiles using latent class analysis in a sample of 3,485 adolescents (ages 13–18, 63% female, 35.7% White, 23.2% Black/African American, 35.0% Hispanic/Latino). Multiple measures of psychological distress and risk behaviors were evaluated as covariates of trauma exposure classes. Results Five trauma exposure classes, or profiles, were identified. Four classes—representing approximately half the sample—were characterized by polyvictimization. Polyvictimization classes were differentiated on number of trauma types, whether emotional abuse occurred, and whether emotional abuse occurred over single or multiple developmental epochs. Unique relations with demographic characteristics and mental health outcomes were observed. Discussion Results suggest polyvictimization is not a unidimensional phenomenon but a diverse set of trauma exposure experiences with unique correlates among youth. Further research on prevention of polyvictimization and mechanisms linking chronic trauma exposure, gender, and ethnicity to negative outcomes is warranted. PMID:26958417

  1. Treatment adherence, clinical outcomes, and economics of triple-drug therapy in hypertensive patients.

    PubMed

    Panjabi, Sumeet; Lacey, Michael; Bancroft, Timothy; Cao, Felix

    2013-01-01

    Poor antihypertensive treatment adherence adversely affects blood pressure control. We analyzed US health plan data to assess the impact of fixed- versus loose-dose triple-combination therapy on adherence, clinical, and economic outcomes. Patients initiating triple therapy with an angiotensin receptor blocker, angiotensin-converting enzyme inhibitor, or beta blocker plus amlodipine and hydrochlorothiazide comprised three cohorts. Within-cohort comparisons were made between fixed-dose combinations of two antihypertensives plus a second pill (two pills) or three separate pills. Outcomes included adherence, cardiovascular events, health care resource use, and costs for patients with ≥ 12 months follow-up. A total of 16,290 patients were matched. Patients receiving two pills were more likely to be adherent (P < .001) and less likely to discontinue treatment (P < .001) across all cohorts. Therapy with two versus three pills resulted in significantly lower adjusted risk of cardiovascular events (hazard ratio = 0.76, P = .005) in the beta blocker cohort only. Total adjusted health care costs were significantly lower for two- versus three-pill therapy in the beta blocker cohort only (cost ratio = 0.74 overall, P < .01; 0.71 hypertension-attributable, P < .01). In patients with hypertension requiring triple therapy, fixed-dose combinations that lower pill burden may improve adherence (seen across all cohorts) and clinical outcomes (seen in the beta blocker cohort) without increasing health care costs.

  2. More Frequent Clinic Visits Are Associated with Improved Outcomes for Children with NAFLD

    PubMed Central

    Lam, Carol; Bandsma, Robert; Ling, Simon

    2016-01-01

    Objective. Adult data suggest that frequent monitoring of patients with nonalcoholic fatty liver disease (NAFLD) may be associated with improved outcomes. The optimal frequency of outpatient visits for the management of pediatric NAFLD remains unknown. Study Design. In this retrospective study, two cohorts of patients with NAFLD, one followed on a yearly basis and one followed on 3-month intervals, were included. Both received similar advice regarding lifestyle changes. Primary outcome was change in BMI z-scores over a year. Secondary outcomes were the change in serum transaminases and markers of metabolic dysregulation. Results. Fifty-six patients were included (28 per group). The majority (71%) were male with a mean (±SD) age of 12.2 (±2.7) years. At baseline, there were no differences in BMI z-scores (2.8 versus 2.9; p = 0.72) and ALT levels (101 versus 100 U/L; p = 0.95) between the groups (yearly versus three-month, resp.). Twelve months later, those followed on a 3-month basis demonstrated a significant decrease in BMI (net BMI z-score change = −0.06; p = 0.37), accompanied by a significant improvement in serum ALT (−25 U/L; p < 0.01) and AST (−13 U/L; p = 0.03) levels. There were no differences in fasting lipid profiles. Conclusion. Frequent clinic visits are associated with improved outcomes in pediatric NAFLD. PMID:28058253

  3. Bacterial pneumonia following cytotoxic chemotherapy for lung cancer: clinical features, treatment outcome and prognostic factors.

    PubMed

    Yoo, Seung Soo; Cha, Seung-Ick; Shin, Kyung-Min; Lee, Shin-Yup; Kim, Chang-Ho; Park, Jae-Yong; Jung, Tae-Hoon

    2010-10-01

    Data regarding treatment outcomes and prognosis in pneumonia that occurs after lung cancer chemotherapy are lacking. We performed a retrospective study of 84 patients with clinically suspected bacterial pneumonia after cytotoxic chemotherapy for lung cancer. Small cell carcinoma was the most common histological type (36.9%, n = 31), followed by squamous cell carcinoma (35.7%, n = 30) and adenocarcinoma (21.4%, n = 18). The most frequent pathogen was Streptococcus pneumoniae (n = 14), followed by Klebsiella pneumoniae (n = 10), Staphylococcus aureus (n = 8), and Pseudomonas aeruginosa (n = 7). Of 84 patients, treatment outcome was determined for 80; the outcome was success in 52 (61.9%) and failure in 28 (33.3%); outcome remained undetermined for 4 patients (4.8%). Based on multivariate analysis, tachypnoea (respiratory rate ≥20/min) was the only significant predictor of treatment failure (odds ratio 4.79, 95% confidence interval 1.17-19.70; p = 0.030). In conclusion, bacterial pneumonia after cytotoxic chemotherapy for lung cancer was found to be caused more often by S. pneumoniae and K. pneumoniae than P. aeruginosa, and treatment failure leading to death was found to be high. Tachypnoea was independently associated with treatment failure in this population.

  4. Melancholic features in inpatients with major depressive disorder associate with differential