Screening older cancer patients for a Comprehensive Geriatric Assessment: A comparison of three instruments

PubMed Central

Owusu, Cynthia; Koroukian, Siran M.; Schluchter, Mark; Bakaki, Paul; Berger, Nathan A.

2011-01-01

Background The Vulnerable Elders Survey (VES-13) has been validated for screening older cancer patients for a Comprehensive Geriatric Assessment (CGA). To identify a widely acceptable approach that encourages oncologists to screen older cancer patients for a CGA, we examined the Eastern Cooperative Oncology Group Performance Status (ECOG-PS) and Karnofsky Index of Performance Status (KPS) scales’ ability to identify abnormalities on a CGA and compared the performance of the two instruments with the VES-13. Methods We enrolled 117 participants, ≥65 years with stage I–IV cancer into this cross-sectional study. Our primary outcome variable was ≥two abnormalities on the CGA, (Yes or No). We employed receiver operating characteristic curve analysis to compare the discriminatory abilities of the three instruments to identify ≥two abnormalities on the CGA. Results Of the 117 participants, 43% had ≥two abnormalities on the CGA. The VES-13 was predictive of ≥two abnormalities on the CGA, area under the curve (AUC)=0.85 [(95% CI: 0.78–0.92); sensitivity=88%, specificity=69%, at cut-off ≥3]. The ECOG-PS and KPS showed similar discriminatory powers, AUC=0.88 [(95% CI: 0.83–0.94); sensitivity=94%, specificity=55%, at cut-off ≥1]; and AUC=0.90 [(95% CI: 0.84–0.96); sensitivity=78%, specificity=91%, at cut-off ≤80%], respectively. Conclusion The ECOG-PS and KPS were equivalent to the VES-13 in identifying older cancer patients with at least two abnormalities on the CGA. Given that oncologists are already conversant with the KPS and ECOG-PS, these two instruments offer medical oncologists a widely acceptable approach for screening older patients for a CGA. PMID:21927633

Randomized Phase III Clinical Trial of Five Different Arms of Treatment in 332 Patients with Cancer Cachexia

PubMed Central

Macciò, Antonio; Madeddu, Clelia; Serpe, Roberto; Massa, Elena; Dessì, Mariele; Panzone, Filomena; Contu, Paolo

2010-01-01

Purpose. A phase III, randomized study was carried out to establish the most effective and safest treatment to improve the primary endpoints of cancer cachexia—lean body mass (LBM), resting energy expenditure (REE), and fatigue—and relevant secondary endpoints: appetite, quality of life, grip strength, Glasgow Prognostic Score (GPS) and proinflammatory cytokines. Patients and Methods. Three hundred thirty-two assessable patients with cancer-related anorexia/cachexia syndrome were randomly assigned to one of five treatment arms: arm 1, medroxyprogesterone (500 mg/day) or megestrol acetate (320 mg/day); arm 2, oral supplementation with eicosapentaenoic acid; arm 3, L-carnitine (4 g/day); arm 4, thalidomide (200 mg/day); and arm 5, a combination of the above. Treatment duration was 4 months. Results. Analysis of variance showed a significant difference between treatment arms. A post hoc analysis showed the superiority of arm 5 over the others for all primary endpoints. An analysis of changes from baseline showed that LBM (by dual-energy X-ray absorptiometry and by L3 computed tomography) significantly increased in arm 5. REE decreased significantly and fatigue improved significantly in arm 5. Appetite increased significantly in arm 5; interleukin (IL)-6 decreased significantly in arm 5 and arm 4; GPS and Eastern Cooperative Oncology Group performance status (ECOG PS) score decreased significantly in arm 5, arm 4, and arm 3. Toxicity was quite negligible, and was comparable between arms. Conclusion. The most effective treatment in terms of all three primary efficacy endpoints and the secondary endpoints appetite, IL-6, GPS, and ECOG PS score was the combination regimen that included all selected agents. PMID:20156909

Patient-Reported Functional Status in Outpatients With Advanced Cancer: Correlation With Physician-Reported Scores and Survival.

PubMed

Popovic, Gordana; Harhara, Thana; Pope, Ashley; Al-Awamer, Ahmed; Banerjee, Subrata; Bryson, John; Mak, Ernie; Lau, Jenny; Hannon, Breffni; Swami, Nadia; Le, Lisa W; Zimmermann, Camilla

2018-06-01

Performance status measures are increasingly completed by patients in outpatient cancer settings, but are not well validated for this use. We assessed performance of a patient-reported functional status measure (PRFS, based on the Eastern Cooperative Oncology Group [ECOG]), compared with the physician-completed ECOG, in terms of agreement in ratings and prediction of survival. Patients and physicians independently completed five-point PRFS (lay version of ECOG) and ECOG measures on first consultation at an oncology palliative care clinic. We assessed agreement between PRFS and ECOG using weighted Kappa statistics, and used linear regression to determine factors associated with the difference between PRFS and ECOG ratings. We used the Kaplan-Meier method to estimate the patients' median survival, categorized by PRFS and ECOG, and assessed predictive accuracy of these measures using the C-statistic. For the 949 patients, there was moderate agreement between PRFS and ECOG (weighted Kappa 0.32; 95% CI: 0.28-0.36). On average, patients' ratings of performance status were worse by 0.31 points (95% CI: 0.25-0.37, P < 0.0001); this tendency was greater for younger patients (P = 0.002) and those with worse symptoms (P < 0.0001). Both PRFS and ECOG scores correlated well with overall survival; the C-statistic was higher for the average of PRFS and ECOG scores (0.619) than when reported individually (0.596 and 0.604, respectively). Patients tend to rate their performance status worse than physicians, particularly if they are younger or have greater symptom burden. Prognostic ability of performance status could be improved by using the average of patients and physician scores. Copyright © 2018 American Academy of Hospice and Palliative Medicine. Published by Elsevier Inc. All rights reserved.

Predicting the failure of retrograde ureteral stent insertion for managing malignant ureteral obstruction in outpatients

PubMed Central

WANG, JIN-YOU; ZHANG, HAI-LIANG; ZHU, YAO; QIN, XIAO-JIAN; DAI, BO; YE, DING-WEI

2016-01-01

Malignant ureteral obstruction (MUO) is an unpropitious sign that is commonly observed in patients with advanced incurable cancer. The present study aimed to evaluate predictive factors for the failure of retrograde ureteral stent insertion in the management of MUO in outpatients. A total of 164 patients with MUO were retrospectively assessed in this study. Clinical factors, including age, gender, type of malignancy, level of obstruction, cause of obstruction, pre-operative creatinine level, degree of hydronephrosis, condition of the contralateral ureter, prior radiotherapy, Eastern Cooperative Oncology Group performance status (ECOG PS), bladder wall invasion and technical failure, were recorded for each case. Univariate and multivariate logistic regression analyses were used to investigate the risk factors for predicting the failure of retrograde ureteral stent insertion. In total, 38 out of 164 patients experienced bilateral obstruction, therefore, a total of 202 ureteral units were available for data analysis. The rate of insertion failure in MUO was 34.65%. Multivariate analyses identified ECOG PS, degree of hydronephrosis and bladder wall invasion as independent predictors for insertion failure. Overall, the present study found that rate of retrograde ureteral stent insertion failure is high in outpatients with MUO, and that ECOG PS, degree of hydronephrosis and bladder invasion are potential independent predictors of insertion failure. PMID:26870299

Changes in health-related quality of life and quality of care among terminally ill cancer patients and survival prediction: Multicenter prospective cohort study.

PubMed

Lee, Myung Kyung; Lee, Woo Jin; Do, Young Rok; Lee, Keun Seok; Jung, Kyung Hae; Heo, Dae Seog; Kim, Sam Yong; Park, Sang Yoon; Jeong, Hyun Sik; Kang, Jung Hun; Kim, Si-Young; Park, Sook Ryun; Yun, Young Ho

2015-08-01

This study examined changes in health-related quality of life (HRQoL) and quality of care (QoC) as perceived by terminally ill cancer patients and a stratified set of HRQoL or QoC factors that are most likely to influence survival at the end of life (EoL). We administered questionnaires to 619 consecutive patients immediately after they were diagnosed with terminal cancer by physicians at 11 university hospitals and at the National Cancer Center in Korea. Subjects were followed up over 161.2 person-years until their deaths. We measured HRQoL using the core 30-item European Organization for Research and Treatment of Cancer Quality of Life Questionnaire, and QoC using the Quality Care Questionnaire-End of Life (QCQ-EoL). We evaluated changes in HRQoL and QoC issues during the first three months after enrollment, performing sensitivity analysis by using data generated via four methods (complete case analysis, available case analysis, the last observation carried forward, and multiple imputation). Emotional and cognitive functioning decreased significantly over time, while dyspnea, constipation, and pain increased significantly. Dignity-conserving care, care by healthcare professionals, family relationships, and QCQ-EoL total score decreased significantly. Global QoL, appetite loss, and Eastern Cooperative Oncology Group Performance Status (ECOG-PS) scores were significantly associated with survival. Future standardization of palliative care should be focused on assessment of these deteriorated types of quality. Accurate estimates of the length of life remaining for terminally ill cancer patients by such EoL-enhancing factors as global QoL, appetite loss, and ECOG-PS are needed to help patients experience a dignified and comfortable death.

Comparison of orally administered cannabis extract and delta-9-tetrahydrocannabinol in treating patients with cancer-related anorexia-cachexia syndrome: a multicenter, phase III, randomized, double-blind, placebo-controlled clinical trial from the Cannabis-In-Cachexia-Study-Group.

PubMed

Strasser, Florian; Luftner, Diana; Possinger, Kurt; Ernst, Gernot; Ruhstaller, Thomas; Meissner, Winfried; Ko, You-Dschun; Schnelle, Martin; Reif, Marcus; Cerny, Thomas

2006-07-20

To compare the effects of cannabis extract (CE), delta-9-tetrahydrocannabinol (THC), and placebo (PL) on appetite and quality of life (QOL) in patients with cancer-related anorexia-cachexia syndrome (CACS). Adult patients with advanced cancer, CACS, weight loss (> or = 5% over 6 months), and Eastern Cooperative Oncology Group (ECOG) performance status (PS) < or = 2 were randomly assigned (2:2:1) to receive CE (standardized for 2.5 mg THC and 1 mg cannabidiol) or THC (2.5 mg) or PL orally, twice daily for 6 weeks. Appetite, mood, and nausea were monitored daily with a visual analog scale (VAS); QOL was assessed with the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (composite score: questions 29 and 30). Cannabinoid-related toxicity was assessed every 2 weeks. Of 289 patients screened, 243 were randomly assigned and 164 (CE, 66 of 95 patients; THC, 65 of 100 patients; and PL, 33 of 48 patients) completed treatment. At baseline, groups were comparable for age (mean, 61 years), sex (54% men), weight loss (32% > or = 10%), PS (13% ECOG = 2), antineoplastic treatment (50%), appetite (mean VAS score, 31/100 mm), and QOL (mean score, 30/100). Intent-to-treat analysis showed no significant differences between the three arms for appetite, QOL, or cannabinoid-related toxicity. Increased appetite was reported by 73%, 58%, and 69% of patients receiving CE, THC, or PL, respectively. An independent data review board recommended termination of recruitment because of insufficient differences between study arms. CE at the oral dose administered was well tolerated by these patients with CACS. No differences in patients' appetite or QOL were found either between CE, THC, and PL or between CE and THC at the dosages investigated.

The effects of performance status one week before hospital admission on the outcomes of critically ill patients.

PubMed

Zampieri, Fernando G; Bozza, Fernando A; Moralez, Giulliana M; Mazza, Débora D S; Scotti, Alexandre V; Santino, Marcelo S; Ribeiro, Rubens A B; Rodrigues Filho, Edison M; Cabral, Maurício M; Maia, Marcelo O; D'Alessandro, Patrícia S; Oliveira, Sandro V; Menezes, Márcia A M; Caser, Eliana B; Lannes, Roberto S; Alencar Neto, Meton S; Machado, Maristela M; Sousa, Marcelo F; Salluh, Jorge I F; Soares, Marcio

2017-01-01

To assess the impact of performance status (PS) impairment 1 week before hospital admission on the outcomes in patients admitted to intensive care units (ICU). Retrospective cohort study in 59,693 patients (medical admissions, 67 %) admitted to 78 ICUs during 2013. We classified PS impairment according to the Eastern Cooperative Oncology Group (ECOG) scale in absent/minor (PS = 0-1), moderate (PS = 2) or severe (PS = 3-4). We used univariate and multivariate logistic regression analyses to investigate the association between PS impairment and hospital mortality. PS impairment was moderate in 17.3 % and severe in 6.9 % of patients. The hospital mortality was 14.4 %. Overall, the worse the PS, the higher the ICU and hospital mortality and length of stay. In addition, patients with worse PS were less frequently discharged home. PS impairment was associated with worse outcomes in all SAPS 3, Charlson Comorbidity Index and age quartiles as well as according to the admission type. Adjusting for other relevant clinical characteristics, PS impairment was associated with higher hospital mortality (odds-ratio (OR) = 1.96 (95 % CI 1.63-2.35), for moderate and OR = 4.22 (3.32-5.35), for severe impairment). The effects of PS on the outcome were particularly relevant in the medium range of severity-of-illness. These results were consistent in the subgroup analyses. However, adding PS impairment to the SAPS 3 score improved only slightly its discriminative capability. PS impairment was associated with worse outcomes independently of other markers of chronic health status, particularly for patients in the medium range of severity of illness.

Development of a prediction model for residual disease in newly diagnosed advanced ovarian cancer.

PubMed

Janco, Jo Marie Tran; Glaser, Gretchen; Kim, Bohyun; McGree, Michaela E; Weaver, Amy L; Cliby, William A; Dowdy, Sean C; Bakkum-Gamez, Jamie N

2015-07-01

To construct a tool, using computed tomography (CT) imaging and preoperative clinical variables, to estimate successful primary cytoreduction for advanced epithelial ovarian cancer (EOC). Women who underwent primary cytoreductive surgery for stage IIIC/IV EOC at Mayo Clinic between 1/2/2003 and 12/30/2011 and had preoperative CT images of the abdomen and pelvis within 90days prior to their surgery available for review were included. CT images were reviewed for large-volume ascites, diffuse peritoneal thickening (DPT), omental cake, lymphadenopathy (LP), and spleen or liver involvement. Preoperative factors included age, body mass index (BMI), Eastern Cooperative Oncology Group performance status (ECOG PS), American Society of Anesthesiologists (ASA) score, albumin, CA-125, and thrombocytosis. Two prediction models were developed to estimate the probability of (i) complete and (ii) suboptimal cytoreduction (residual disease (RD) >1cm) using multivariable logistic analysis with backward and stepwise variable selection methods. Internal validation was assessed using bootstrap resampling to derive an optimism-corrected estimate of the c-index. 279 patients met inclusion criteria: 143 had complete cytoreduction, 26 had suboptimal cytoreduction (RD>1cm), and 110 had measurable RD ≤1cm. On multivariable analysis, age, absence of ascites, omental cake, and DPT on CT imaging independently predicted complete cytoreduction (c-index=0.748). Conversely, predictors of suboptimal cytoreduction were ECOG PS, DPT, and LP on preoperative CT imaging (c-index=0.685). The generated models serve as preoperative evaluation tools that may improve counseling and selection for primary surgery, but need to be externally validated. Copyright © 2015 Elsevier Inc. All rights reserved.

Fixed-dose-rate gemcitabine: a viable first-line treatment option for advanced pancreatic and biliary tract cancer.

PubMed

Milella, Michele; Gelibter, Alain J; Pino, Maria Simona; Bossone, Giandominik; Marolla, Paolo; Sperduti, Isabella; Cognetti, Francesco

2010-01-01

We have already reported on fixed-dose-rate gemcitabine (FDR-Gem) in advanced, inoperable pancreatic ductal adenocarcinoma (PDAC) and biliary tract cancer (BTC) in the context of a formal phase II study; building on that experience, we have now expanded the study to reach a cumulative accrual of 106 patients. One hundred six patients (PDAC/BTC, 75/31) were treated with weekly FDR-Gem (1,000 mg/m(2) infused at 10 mg/m(2) per minute). Patient characteristics included: male-to-female ratio, 0.83; median age, 63 years (range, 28-82); metastatic disease in 66% of patients; and an Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0-1 in 81% of patients. The median and total number of treatment weeks delivered were 8 (range, 2-22) and 1,154, respectively. Thirteen percent of patients achieved an objective response, 42% experienced a positive clinical benefit response, and 54% achieved a >50% reduction in serum cancer antigen (CA)19.9 levels. The median progression-free survival (PFS) and overall survival (OS) times for the entire population were 4.4 months (95% confidence interval [CI], 3.5-5.1 months) and 7.7 months (95% CI, 6.3-8.8 months), respectively, with 20% of patients alive at 1 year. On multivariate analysis, a CA19.9 reduction >50% and baseline ECOG PS score of 0 were the only independent predictors of PFS and OS, respectively. Treatment was well tolerated, with grade 3-4 neutropenia in 47 of 1,154 treatment weeks (4.1%), and grade 3 anemia and thrombocytopenia in 8 of 1,154 (0.7%) and 16 of 1,154 (1.4%) treatment weeks, respectively. Currently available evidence, including this updated analysis, supports the use of FDR-Gem as a first-line option in advanced PDAC, and possibly in BTC, patients and prompts the continued evaluation of this approach in combination regimens.

Prognostic risk stratification derived from individual patient level data for men with advanced penile squamous cell carcinoma receiving first-line systemic therapy.

PubMed

Pond, Gregory R; Di Lorenzo, Giuseppe; Necchi, Andrea; Eigl, Bernhard J; Kolinsky, Michael P; Chacko, Raju T; Dorff, Tanya B; Harshman, Lauren C; Milowsky, Matthew I; Lee, Richard J; Galsky, Matthew D; Federico, Piera; Bolger, Graeme; DeShazo, Mollie; Mehta, Amitkumar; Goyal, Jatinder; Sonpavde, Guru

2014-05-01

Prognostic factors in men with penile squamous cell carcinoma (PSCC) receiving systemic therapy are unknown. A prognostic classification system in this disease may facilitate interpretation of outcomes and guide rational drug development. We performed a retrospective analysis to identify prognostic factors in men with PSCC receiving first-line systemic therapy for advanced disease. Individual patient level data were obtained from 13 institutions to study prognostic factors in the context of first-line systemic therapy for advanced PSCC. Cox proportional hazards regression analysis was conducted to examine the prognostic effect of these candidate factors on progression-free survival (PFS) and overall survival (OS): age, stage, hemoglobin, neutrophil count, lymphocyte count, albumin, site of metastasis (visceral or nonvisceral), smoking, circumcision, regimen, ECOG performance status (PS), lymphovascular invasion, precancerous lesion, and surgery following chemotherapy. The effect of different treatments was then evaluated adjusting for factors in the prognostic model. The study included 140 eligible men. Mean age across all men was 57.0 years. Among them, 8.6%, 21.4%, and 70.0% of patients had stage 2, 3, and 4 diseases, respectively; 40.7% had ECOG PS ≥ 1, 47.4% had visceral metastases, and 73.6% received cisplatin-based chemotherapy. The multivariate model of poor prognostic factors included visceral metastases (P<0.001) and ECOG PS ≥ 1 (P<0.001) for both PFS and OS. A risk stratification model constructed with 0, 1, and both poor prognostic factors was internally validated and demonstrated moderate discriminatory ability (c-statistic of 0.657 and 0.677 for OS and PFS, respectively). The median OS for the entire population was 9 months. Median OS was not reached, 8, and 7 months for those with 0, 1, and both risk factors, respectively. Cisplatin-based regimens were associated with better OS (P = 0.017) but not PFS (P = 0.37) compared with noncisplatin-based regimens after adjusting for the 2 prognostic factors. In men with advanced PSCC receiving first-line systemic therapy, visceral metastases and ECOG PS ≥ 1 were poor prognostic factors. A prognostic model including these factors exhibited moderate discriminatory ability for outcomes and warrants external validation. Patients receiving cisplatin-based regimens exhibited better outcomes compared with noncisplatin-based regimens after adjusting for prognostic factors. © 2013 Published by Elsevier Inc.

Time from prior chemotherapy enhances prognostic risk grouping in the second-line setting of advanced urothelial carcinoma: a retrospective analysis of pooled, prospective phase 2 trials.

PubMed

Sonpavde, Guru; Pond, Gregory R; Fougeray, Ronan; Choueiri, Toni K; Qu, Angela Q; Vaughn, David J; Niegisch, Guenter; Albers, Peter; James, Nicholas D; Wong, Yu-Ning; Ko, Yoo-Joung; Sridhar, Srikala S; Galsky, Matthew D; Petrylak, Daniel P; Vaishampayan, Ulka N; Khan, Awais; Vogelzang, Nicholas J; Beer, Tomasz M; Stadler, Walter M; O'Donnell, Peter H; Sternberg, Cora N; Rosenberg, Jonathan E; Bellmunt, Joaquim

2013-04-01

Outcomes for patients in the second-line setting of advanced urothelial carcinoma (UC) are dismal. The recognized prognostic factors in this context are Eastern Cooperative Oncology Group (ECOG) performance status (PS) >0, hemoglobin level (Hb) <10 g/dl, and liver metastasis (LM). The purpose of this retrospective study of prospective trials was to investigate the prognostic value of time from prior chemotherapy (TFPC) independent of known prognostic factors. Data from patients from seven prospective trials with available baseline TFPC, Hb, PS, and LM values were used for retrospective analysis (n=570). External validation was conducted in a second-line phase 3 trial comparing best supportive care (BSC) versus vinflunine plus BSC (n=352). Cox proportional hazards regression was used to evaluate the association of factors, with overall survival (OS) and progression-free survival (PFS) being the respective primary and secondary outcome measures. ECOG-PS >0, LM, Hb <10 g/dl, and shorter TFPC were significant prognostic factors for OS and PFS on multivariable analysis. Patients with zero, one, two, and three to four factors demonstrated median OS of 12.2, 6.7, 5.1, and 3.0 mo, respectively (concordance statistic=0.638). Setting of prior chemotherapy (metastatic disease vs perioperative) and prior platinum agent (cisplatin or carboplatin) were not prognostic factors. External validation demonstrated a significant association of TFPC with PFS on univariable and most multivariable analyses, and with OS on univariable analyses. Limitations of retrospective analyses are applicable. Shorter TFPC enhances prognostic classification independent of ECOG-PS >0, Hb <10 g/dl, and LM in the setting of second-line therapy for advanced UC. These data may facilitate drug development and interpretation of trials. Copyright © 2012 European Association of Urology. Published by Elsevier B.V. All rights reserved.

Time from Prior Chemotherapy Enhances Prognostic Risk Grouping in the Second-line Setting of Advanced Urothelial Carcinoma: A Retrospective Analysis of Pooled, Prospective Phase 2 Trials

PubMed Central

Sonpavde, Guru; Pond, Gregory R.; Fougeray, Ronan; Choueiri, Toni K.; Qu, Angela Q.; Vaughn, David J.; Niegisch, Guenter; Albers, Peter; James, Nicholas D.; Wong, Yu-Ning; Ko, Yoo-Joung; Sridhar, Srikala S.; Galsky, Matthew D.; Petrylak, Daniel P.; Vaishampayan, Ulka N.; Khan, Awais; Vogelzang, Nicholas J.; Beer, Tomasz M.; Stadler, Walter M.; O’Donnell, Peter H.; Sternberg, Cora N.; Rosenberg, Jonathan E.; Bellmunt, Joaquim

2014-01-01

Background Outcomes for patients in the second-line setting of advanced urothelial carcinoma (UC) are dismal. The recognized prognostic factors in this context are Eastern Cooperative Oncology Group (ECOG) performance status (PS) >0, hemoglobin level (Hb) <10 g/dl, and liver metastasis (LM). Objectives The purpose of this retrospective study of prospective trials was to investigate the prognostic value of time from prior chemotherapy (TFPC) independent of known prognostic factors. Design, setting, and participants: Data from patients from seven prospective trials with available baseline TFPC, Hb, PS, and LM values were used for retrospective analysis (n = 570). External validation was conducted in a second-line phase 3 trial comparing best supportive care (BSC) versus vinflunine plus BSC (n = 352). Outcome measurements and statistical analysis Cox proportional hazards regression was used to evaluate the association of factors, with overall survival (OS) and progression-free survival (PFS) being the respective primary and secondary outcome measures. Results and limitations ECOG-PS >0, LM, Hb <10 g/dl, and shorter TFPC were significant prognostic factors for OS and PFS on multivariable analysis. Patients with zero, one, two, and three to four factors demonstrated median OS of 12.2, 6.7, 5.1, and 3.0 mo, respectively (concordance statistic = 0.638). Setting of prior chemotherapy (metastatic disease vs perioperative) and prior platinum agent (cisplatin or carboplatin) were not prognostic factors. External validation demonstrated a significant association of TFPC with PFS on univariable and most multivariable analyses, and with OS on univariable analyses. Limitations of retrospective analyses are applicable. Conclusions Shorter TFPC enhances prognostic classification independent of ECOG-PS>0, Hb<10 g/ dl, and LM in the setting of second-line therapy for advanced UC. These data may facilitate drug development and interpretation of trials. PMID:23206856

Validity and Reliability of the US National Cancer Institute's Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE).

PubMed

Dueck, Amylou C; Mendoza, Tito R; Mitchell, Sandra A; Reeve, Bryce B; Castro, Kathleen M; Rogak, Lauren J; Atkinson, Thomas M; Bennett, Antonia V; Denicoff, Andrea M; O'Mara, Ann M; Li, Yuelin; Clauser, Steven B; Bryant, Donna M; Bearden, James D; Gillis, Theresa A; Harness, Jay K; Siegel, Robert D; Paul, Diane B; Cleeland, Charles S; Schrag, Deborah; Sloan, Jeff A; Abernethy, Amy P; Bruner, Deborah W; Minasian, Lori M; Basch, Ethan

2015-11-01

To integrate the patient perspective into adverse event reporting, the National Cancer Institute developed a patient-reported outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). To assess the construct validity, test-retest reliability, and responsiveness of PRO-CTCAE items. A total of 975 adults with cancer undergoing outpatient chemotherapy and/or radiation therapy enrolled in this questionnaire-based study between January 2011 and February 2012. Eligible participants could read English and had no clinically significant cognitive impairment. They completed PRO-CTCAE items on tablet computers in clinic waiting rooms at 9 US cancer centers and community oncology practices at 2 visits 1 to 6 weeks apart. A subset completed PRO-CTCAE items during an additional visit 1 business day after the first visit. Primary comparators were clinician-reported Eastern Cooperative Oncology Group Performance Status (ECOG PS) and the European Organisation for Research and Treatment of Cancer Core Quality of Life Questionnaire (QLQ-C30). A total of 940 of 975 (96.4%) and 852 of 940 (90.6%) participants completed PRO-CTCAE items at visits 1 and 2, respectively. At least 1 symptom was reported by 938 of 940 (99.8%) participants. Participants' median age was 59 years; 57.3% were female, 32.4% had a high school education or less, and 17.1% had an ECOG PS of 2 to 4. All PRO-CTCAE items had at least 1 correlation in the expected direction with a QLQ-C30 scale (111 of 124, P<.05 for all). Stronger correlations were seen between PRO-CTCAE items and conceptually related QLQ-C30 domains. Scores for 94 of 124 PRO-CTCAE items were higher in the ECOG PS 2 to 4 vs 0 to 1 group (58 of 124, P<.05 for all). Overall, 119 of 124 items met at least 1 construct validity criterion. Test-retest reliability was 0.7 or greater for 36 of 49 prespecified items (median [range] intraclass correlation coefficient, 0.76 [0.53-.96]). Correlations between PRO-CTCAE item changes and corresponding QLQ-C30 scale changes were statistically significant for 27 prespecified items (median [range] r=0.43 [0.10-.56]; all P≤.006). Evidence demonstrates favorable validity, reliability, and responsiveness of PRO-CTCAE in a large, heterogeneous US sample of patients undergoing cancer treatment. Studies evaluating other measurement properties of PRO-CTCAE are under way to inform further development of PRO-CTCAE and its inclusion in cancer trials.

Comparison of stereotactic radiosurgery (SRS) alone and whole brain radiotherapy (WBRT) plus a stereotactic boost (WBRT+SRS) for one to three brain metastases.

PubMed

Rades, Dirk; Kueter, Jan-Dirk; Hornung, Dagmar; Veninga, Theo; Hanssens, Patrick; Schild, Steven E; Dunst, Juergen

2008-12-01

The best available treatment of patients with one to three brain metastases is still unclear. This study compared the results of stereotactic radiosurgery (SRS) alone and whole brain radiotherapy (WBRT) plus SRS (WBRT+SRS). Survival (OS), intracerebral control (IC), and local control of treated metastases (LC) were retrospectively analyzed in 144 patients receiving SRS alone (n=93) or WBRT+SRS (n=51). Eight additional potential prognostic factors were evaluated: age, gender, Eastern Cooperative Oncology Group performance score (ECOG-PS), tumor type, number of brain metastases, extracerebral metastases, recursive partitioning analysis (RPA) class, and interval from tumor diagnosis to irradiation. Subgroup analyses were performed for RPA class I and II patients. 1-year-OS was 53% after SRS and 56% after WBRT+SRS (p=0.24). 1-year-IC rates were 51% and 66% (p=0.015), respectively. 1-year-LC rates were 66% and 87% (p=0.003), respectively. On multivariate analyses, OS was associated with age (p=0.004), ECOG-PS (p=0.005), extracerebral metastases (p<0.001), RPA class (p<0.001), and interval from tumor diagnosis to irradiation (p<0.001). IC was associated with interval from tumor diagnosis to irradiation (p=0.004) and almost with treatment (p=0.09), and LC with treatment (p=0.026) and almost with interval (p=0.08). The results of the subgroup analyses were similar to those of the entire cohort. The increase in IC was stronger in RPA class I patients. WBRT+SRS resulted in better IC and LC but not better OS than SRS alone. Because also IC and LC are important end-points, additional WBRT appears justified in patients with one to three brain metastases, in particular in RPA class I patients.

Factors Associated with Short-Term Mortality After Surgical Oncologic Emergencies.

PubMed

Bosscher, Marianne R F; Bastiaannet, Esther; van Leeuwen, Barbara L; Hoekstra, Harald J

2016-06-01

The clinical outcome of patients with oncologic emergencies is often poor and mortality is high. It is important to determine which patients may benefit from invasive treatment, and for whom conservative treatment and/or palliative care would be appropriate. In this study, prognostic factors for clinical outcome are identified in order to facilitate the decision-making process for patients with surgical oncologic emergencies. This was a prospective registration study for patients over 18 years of age, who were consulted for surgical oncologic emergencies between November 2013 and April 2014. Multiple variables were registered upon emergency consultation, and the follow-up period was 90 days. Multivariate logistic regression analysis was performed to identify factors associated with 30- and 90-day mortality. During the study period, 207 patients experienced surgical oncologic emergencies-101 (48.8 %) men and 106 (51.2 %) women, with a median age of 64 years (range 19-92). The 30-day mortality was 12.6 % and 90-day mortality was 21.7 %. Factors significantly associated with 30-day mortality were palliative intent of cancer treatment prior to emergency consultation (p = 0.006), Eastern Cooperative Oncology Group performance score (ECOG-PS) >0 (p for trend: p = 0.03), and raised lactate dehydrogenase (LDH) (p < 0.001). Additional factors associated with 90-day mortality were low handgrip strength (HGS) (p = 0.01) and low albumin (p = 0.002). Defining the intent of prior cancer treatment and the ECOG-PS are of prognostic value when deciding on treatment for patients with surgical oncologic emergencies. Additional measurements of HGS, LDH, and albumin levels can serve as objective parameters to support the clinical assessment of individual prognosis.

Capecitabine and lapatinib for the first-line treatment of metastatic/recurrent head and neck squamous cell carcinoma.

PubMed

Weiss, Jared M; Bagley, Stephen; Hwang, Wei-Ting; Bauml, Joshua; Olson, Juneko Grilley; Cohen, Roger B; Hayes, David Neil; Langer, Corey

2016-08-01

The combination of cisplatin, 5-fluorouracil, and cetuximab is a standard treatment for patients with recurrent/metastatic head and neck cancer, with a high rate of toxicity. Identifying less toxic, equally effective regimens is imperative. Therefore, in the current study, the authors investigated first-line treatment with an all-oral regimen of capecitabine and lapatinib. Patients were required to have incurable head and neck cancer of any primary site other than the nasopharynx, an Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 to 2, and no prior exposure to capecitabine or lapatinib. Subjects were treated with capecitabine at a dose of 1000 mg/m(2) twice daily and lapatinib at a dose of 1250 mg daily. Capecitabine was administered for 14 days of each 21-day cycle for 4 cycles. Lapatinib was administered daily until disease progression. The primary outcome was overall survival. A total of 44 subjects were accrued between November 13, 2009 and April 29, 2014. Approximately 38.6% of the sample had an ECOG PS of 0, 52.3% had an ECOG PS of 1, and 9.1% had an ECOG PS of 2. Approximately 81.8% were male and the median age of the patients was 62 years. Prior attempts at curative treatment with chemotherapy had been used in 68.2% of patients (platinum was used in 55.8%). There was no grade 5 toxicity noted (toxicity was graded according to National Cancer Institute Common Terminology Criteria for Adverse Events [version 3.0]). The most common adverse events were diarrhea (18.2% of patients with grade 3) and rash (13.6% of patients with grade 3). The primary objective was met; the median overall survival was 10.7 months (90% confidence interval [90% CI], 8.7-12.9 months). The overall response rate was 25% (90% CI, 15%-38%). The median progression-free survival was 4.2 months (90% CI, 3.6-5.1 months). The results were not substantially different when subdivided by p16 status. Only 2 patients were positive for human epidermal growth factor receptor 2 by immunohistochemistry. The current study met its primary objective of survival comparable to the combination of cisplatin, 5-FU and cetuximab regimen, and the toxicity of this all-oral regimen was tolerable. Cancer 2016;122:2350-2355. © 2016 American Cancer Society. © 2016 American Cancer Society.

Should spikes on post-resection ECoG guide pediatric epilepsy surgery?

PubMed

Greiner, Hansel M; Horn, Paul S; Tenney, Jeffrey R; Arya, Ravindra; Jain, Sejal V; Holland, Katherine D; Leach, James L; Miles, Lili; Rose, Douglas F; Fujiwara, Hisako; Mangano, Francesco T

2016-05-01

There is wide variation in clinical practice regarding the role of electrocorticography immediately after resection (post-resection ECoG) for pediatric epilepsy surgery. Results can guide further resection of potentially epileptogenic tissue. We hypothesized that post-resection ECoG spiking represents a biomarker of the epileptogenic zone and predicts seizure outcome in children undergoing epilepsy surgery. We retrospectively identified 124 children with post-resection ECoG performed on the margins of resection. ECoG records were scored in a blinded fashion based on presence of frequent spiking. For patients identified as having additional resection based on clinical post-resection ECoG interpretation, these "second-look" ECoG results were re-reviewed for ongoing discharges or completeness of resection. Frequent spike populations were grouped using a standard scoring system into three ranges: 0.1-0.5Hz, 0.5-1Hz, >1Hz. Seizure outcomes were determined at minimum 12-month followup. Of 124 patients who met inclusion criteria, 60 (48%) had an identified spike population on post-resection ECoG. Thirty (50%) of these had further resection based on clinical interpretation. Overall, good outcome (ILAE 1) was seen in 56/124 (45%). Completeness of resection of spiking (absence of spiking on initial post-resection ECoG or resolution of spiking after further resection) showed a trend toward good outcome (OR 2.03, p=0.099). Patients with completeness of resection had good outcome in 41/80 (51%) of cases; patients with continued spikes had good outcome in 15/44 (35%) of cases. Post-resection ECoG identifies residual epileptogenic tissue in a significant number of children. Lower frequency or absence of discharges on initial recording showed a trend toward good outcome. Completeness of resection demonstrated on final ECoG recording did not show a significant difference in outcome. This suggests that post-resection discharges represent a prognostic marker rather than a remediable biomarker of the epileptogenic zone in all patients. Resecting residual spike-generating cortex may be beneficial in selected patients, including children with tumors. Copyright © 2016 Elsevier B.V. All rights reserved.

Fixed-Dose-Rate Gemcitabine: A Viable First-Line Treatment Option for Advanced Pancreatic and Biliary Tract Cancer

PubMed Central

Milella, Michele; Pino, Maria Simona; Bossone, Giandominik; Marolla, Paolo; Sperduti, Isabella; Cognetti, Francesco

2010-01-01

Background. We have already reported on fixed-dose-rate gemcitabine (FDR-Gem) in advanced, inoperable pancreatic ductal adenocarcinoma (PDAC) and biliary tract cancer (BTC) in the context of a formal phase II study; building on that experience, we have now expanded the study to reach a cumulative accrual of 106 patients. Methods. One hundred six patients (PDAC/BTC, 75/31) were treated with weekly FDR-Gem (1,000 mg/m2 infused at 10 mg/m2 per minute). Patient characteristics included: male-to-female ratio, 0.83; median age, 63 years (range, 28–82); metastatic disease in 66% of patients; and an Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0–1 in 81% of patients. Results. The median and total number of treatment weeks delivered were 8 (range, 2–22) and 1,154, respectively. Thirteen percent of patients achieved an objective response, 42% experienced a positive clinical benefit response, and 54% achieved a >50% reduction in serum cancer antigen (CA)19.9 levels. The median progression-free survival (PFS) and overall survival (OS) times for the entire population were 4.4 months (95% confidence interval [CI], 3.5–5.1 months) and 7.7 months (95% CI, 6.3–8.8 months), respectively, with 20% of patients alive at 1 year. On multivariate analysis, a CA19.9 reduction >50% and baseline ECOG PS score of 0 were the only independent predictors of PFS and OS, respectively. Treatment was well tolerated, with grade 3–4 neutropenia in 47 of 1,154 treatment weeks (4.1%), and grade 3 anemia and thrombocytopenia in 8 of 1,154 (0.7%) and 16 of 1,154 (1.4%) treatment weeks, respectively. Conclusions. Currently available evidence, including this updated analysis, supports the use of FDR-Gem as a first-line option in advanced PDAC, and possibly in BTC, patients and prompts the continued evaluation of this approach in combination regimens. PMID:20189980

Metastatic Pancreatic Cancer: ASCO Clinical Practice Guideline Update.

PubMed

Sohal, Davendra P S; Kennedy, Erin B; Khorana, Alok; Copur, Mehmet S; Crane, Christopher H; Garrido-Laguna, Ignacio; Krishnamurthi, Smitha; Moravek, Cassadie; O'Reilly, Eileen M; Philip, Philip A; Ramanathan, Ramesh K; Ruggiero, Joseph T; Shah, Manish A; Urba, Susan; Uronis, Hope E; Lau, Michelle W; Laheru, Daniel

2018-05-23

Purpose In 2016, ASCO published a guideline to assist in clinical decision making in metastatic pancreatic cancer for initial assessment after diagnosis, first- and second-line treatment options, palliative and supportive care, and follow-up. The purpose of this update is to incorporate new evidence related to second-line therapy for patients who have experienced disease progression or intolerable toxicity during first-line therapy. Methods ASCO convened an Expert Panel to conduct a systematic review of the literature on second-line therapy published between June 2015 and January 2018. Recommendations on other topics covered in the 2016 Metastatic Pancreatic Cancer Guideline were endorsed by the Expert Panel. Results Two new studies were found that met the inclusion criteria. Recommendations For second-line therapy, gemcitabine plus nanoparticle albumin-bound paclitaxel should be offered to patients with first-line treatment with FOLFIRINOX (leucovorin, fluorouracil, irinotecan, and oxaliplatin), an Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 to 1, and a favorable comorbidity profile; fluorouracil plus nanoliposomal irinotecan can be offered to patients with first-line treatment with gemcitabine plus NAB-paclitaxel, an ECOG PS of 0 to 1, and a favorable comorbidity profile; fluorouracil plus irinotecan or fluorouracil plus oxaliplatin may be offered when there is a lack of availability of fluorouracil plus nanoliposomal irinotecan; gemcitabine or fluorouracil should be offered to patients with either an ECOG PS of 2 or a comorbidity profile that precludes other regimens. Testing select patients for mismatch repair deficiency or microsatellite instability is recommended, and pembrolizumab is recommended for patients with mismatch repair deficiency or high microsatellite instability tumors. Endorsed recommendations from the 2016 version of this guideline for computed tomography, baseline performance status and comorbidity profile, defining goals of care, first-line therapy, and palliative care are also contained within the full guideline text. Additional information is available at www.asco.org/gastrointestinal-cancer-guidelines .

Prognostic Significance of Clinicopathologic Features in Patients With Breast Ductal Carcinoma-in-Situ Who Received Breast-Conserving Surgery.

PubMed

Kuo, Sung-Hsin; Lo, Chiao; Chen, Yu-Hsuan; Lien, Huang-Chun; Kuo, Wen-Hung; Wang, Ming-Yang; Lee, Yi-Hsuan; Huang, Chiun-Sheng

2018-04-10

To identify whether a certain group of breast ductal carcinoma-in-situ (DCIS) patients can be treated with breast-conserving surgery (BCS) alone; to analyze the clinicopathologic features of DCIS and tamoxifen administration in patients treated with BCS who developed ipsilateral breast tumor recurrence (IBTR). Data for 375 women with breast DCIS who underwent BCS at our institute between June 2003 and October 2010 were analyzed. The patients were divided into different categories according to the recurrence risk predicted using the California/Van Nuys Prognostic Index (USC/VNPI) score (4-6, 7-9, and 10-12), Eastern Cooperative Oncology Group (ECOG) E5194 criteria, or combined risk features with USC/VNPI score and ECOG E5194 criteria. The IBTR and disease-free survival (DFS) rates were calculated by the Kaplan-Meier method. The prognostic effects of age, tumor size, tumor grade, margin width, estrogen receptor status, USC/VNPI score, low-risk characteristics, and tamoxifen use were evaluated by log-rank tests. Of the patients, 168 were treated with breast irradiation after BCS and 207 were not. The patients who were treated with radiotherapy (RT) tended to be younger (< 40 years), to have higher USC/VNPI scores (7-9), and to meet the ECOG E5194 non-cohort 1 criteria. The 7-year risk of IBTR was 6.2% (n = 11) in the patients who received irradiation and 9.0% (n = 22) in those who did not. DFS rates were better in the patients who underwent RT than in those who did not (93.3% vs. 88.5%, P = .056). Among the patients who underwent BCS alone, age ≥ 40 years, margin width > 10 mm, USC/VNPI scores 4-6, ECOG E5194 cohort 1 criteria, estrogen receptor-positive status, and tamoxifen use predicted lower IBTR and better DFS rates. In the multivariate analysis, combined low-risk characteristics (USC/VNPI scores 4-6 and meeting the ECOG E5194 cohort 1 criteria) were identified as an independent prognostic factor of lower IBTR (P = .028) and better DFS (P = .005). RT reduces the risk of IBTR after BCS for DCIS of the breast. Patients with combined low-risk characteristics (USC/VNPI scores 4-6 and meeting the ECOG E5194 cohort 1 criteria) may be adequately treated with BCS alone. Copyright © 2018 Elsevier Inc. All rights reserved.

Primary CNS Lymphoma in Children and Adolescents: A Descriptive Analysis from the International Primary CNS Lymphoma Collaborative Group (IPCG)

PubMed Central

Abla, Oussama; Weitzman, Sheila; Blay, Jean-Yves; O’Neill, Brian Patrick; Abrey, Lauren E.; Neuwelt, Edward; Doolittle, Nancy D.; Baehring, Joachim; Pradhan, Kamnesh; Martin, S. Eric; Guerrera, Michael; Shah, Shafqat; Ghesquieres, Hervé; Silver, Michael; Betensky, Rebecca A.; Batchelor, Tracy

2014-01-01

Purpose To describe the demographic and clinical features and outcomes for children and adolescents with primary CNS lymphoma (PCNSL). Experimental Design A retrospective series of children and adolescents with PCNSL was assembled from ten cancer centers in three countries. Results Twenty-nine patients with a median age of 14 years were identified. Sixteen (55%) had Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≥ 1. Front line therapy consisted of chemotherapy (CT) only in twenty patients (69%), while 9 (31%) had CT plus cranial radiotherapy. Most patients received methotrexate (MTX)-based regimens. Overall response rate was 86% (CR 69%, PR 17%). The 2 year PFS and OS rates were 61% and 86%, respectively; the 3 year OS was 82%. Univariate analyses were conducted for age (≤ 14 vs > 14 years), PS (0 or 1 vs >1), deep brain lesions, MTX dose, primary treatment with CT alone, intrathecal chemotherapy and high-dose therapy. Primary treatment with CT alone was associated with better overall response rates with an OR of 0.125 (p=0.02). There was a marginally significant relationship between higher doses of MTX and response (OR =1.5, p = 0.06). ECOG-PS of 0–1 was the only factor associated with better outcome with hazard ratios of 0.136 (p = 0.017) and 0.073(p = 0.033) for PFS and OS, respectively. Conclusion This is the largest series collected of pediatric PCNSL. The outcome of children and adolescents appears to be better than in adults. PS of 0–1 is associated with better survival. PMID:21224370

Treatment of Stage IV Non-small Cell Lung Cancer

PubMed Central

Evans, Tracey; Gettinger, Scott; Hensing, Thomas A.; VanDam Sequist, Lecia; Ireland, Belinda; Stinchcombe, Thomas E.

2013-01-01

Background: Stage IV non-small cell lung cancer (NSCLC) is a treatable, but not curable, clinical entity in patients given the diagnosis at a time when their performance status (PS) remains good. Methods: A systematic literature review was performed to update the previous edition of the American College of Chest Physicians Lung Cancer Guidelines. Results: The use of pemetrexed should be restricted to patients with nonsquamous histology. Similarly, bevacizumab in combination with chemotherapy (and as continuation maintenance) should be restricted to patients with nonsquamous histology and an Eastern Cooperative Oncology Group (ECOG) PS of 0 to 1; however, the data now suggest it is safe to use in those patients with treated and controlled brain metastases. Data at this time are insufficient regarding the safety of bevacizumab in patients receiving therapeutic anticoagulation who have an ECOG PS of 2. The role of cetuximab added to chemotherapy remains uncertain and its routine use cannot be recommended. Epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors as first-line therapy are the recommended treatment of those patients identified as having an EGFR mutation. The use of maintenance therapy with either pemetrexed or erlotinib should be considered after four cycles of first-line therapy in those patients without evidence of disease progression. The use of second- and third-line therapy in stage IV NSCLC is recommended in those patients retaining a good PS; however, the benefit of therapy beyond the third-line setting has not been demonstrated. In the elderly and in patients with a poor PS, the use of two-drug, platinum-based regimens is preferred. Palliative care should be initiated early in the course of therapy for stage IV NSCLC. Conclusions: Significant advances continue to be made, and the treatment of stage IV NSCLC has become nuanced and specific for particular histologic subtypes and clinical patient characteristics and according to the presence of specific genetic mutations. PMID:23649446

Eligibility of Metastatic Pancreatic Cancer Patients for First-Line Palliative Intent nab-Paclitaxel Plus Gemcitabine Versus FOLFIRINOX.

PubMed

Peixoto, Renata D; Ho, Maria; Renouf, Daniel J; Lim, Howard J; Gill, Sharlene; Ruan, Jenny Y; Cheung, Winson Y

2017-10-01

The PRODIGE and MPACT trials showed superiority of FOLFIRINOX and nab-paclitaxel plus gemcitabine (NG) over gemcitabine alone, respectively. However, both had strict inclusion criteria. We sought to determine the characteristics of patients with metastatic pancreatic cancer (MPC) which inform the appropriateness of first-line chemotherapy FOLFIRINOX and NG in routine practice. Patients with MPC who initiated palliative chemotherapy with gemcitabine from 2000 to 2011 at the British Columbia Cancer Agency were identified. Clinicopathologic variables and outcomes were retrospectively collected and compared among groups. Eligibility criteria for each regimen were in accordance with the respective pivotal phase III trials. A total of 473 patients were included: 25% of the patients were eligible for FOLFIRINOX versus 45% for NG. Main reasons for FOLFIRINOX ineligibility were Eastern Cooperative Oncology Group (ECOG) performance status (PS)≥2 (56.5%), age older than 75 years (19.0%), and bilirubin>1.5× upper limit of normal (18.6%), whereas those for NG ineligibility were bilirubin > upper limit of normal (24.5%), ECOG PS≥3 (14.6%), and cardiac dysfunction (13.8%). Univariate analyses revealed that FOLFIRINOX and NG-eligible patients had longer median overall survival than their respective ineligible group (8.6 vs. 4.7 mo, P<0.001; 6.7 vs. 4.9 mo, P=0.008, respectively). After accounting for ECOG PS in the multivariate model, however, eligibility for either FOLFIRINOX or NG no longer predicted for better overall survival. The majority of patients with MPC are not candidates to either NG or FOLFIRINOX due to restrictive eligibility requirements. Specific trials addressing the unmet needs of protocol ineligible patients are warranted.

Effect of visceral metastases on the efficacy and safety of everolimus in postmenopausal women with advanced breast cancer: subgroup analysis from the BOLERO-2 study.

PubMed

Campone, Mario; Bachelot, Thomas; Gnant, Michael; Deleu, Ines; Rugo, Hope S; Pistilli, Barbara; Noguchi, Shinzaburo; Shtivelband, Mikhail; Pritchard, Kathleen I; Provencher, Louise; Burris, Howard A; Hart, Lowell; Melichar, Bohuslav; Hortobagyi, Gabriel N; Arena, Francis; Baselga, José; Panneerselvam, Ashok; Héniquez, Aurelia; El-Hashimyt, Mona; Taran, Tetiana; Sahmoud, Tarek; Piccart, Martine

2013-08-01

Everolimus (EVE; an inhibitor of mammalian target of rapamycin [mTOR]) enhances treatment options for postmenopausal women with hormone-receptor-positive (HR(+)), human epidermal growth factor receptor-2-negative (HER2(-)) advanced breast cancer (ABC) who progress on a non-steroidal aromatase inhibitor (NSAI). This is especially true for patients with visceral disease, which is associated with poor prognosis. The BOLERO-2 (Breast cancer trial of OraLEveROlimus-2) trial showed that combination treatment with EVE and exemestane (EXE) versus placebo (PBO)+EXE prolonged progression-free survival (PFS) by both investigator (7.8 versus 3.2 months, respectively) and independent (11.0 versus 4.1 months, respectively) central assessment in postmenopausal women with HR(+), HER2(-) ABC recurring/progressing during/after NSAI therapy. The BOLERO-2 trial included a substantial proportion of patients with visceral metastases (56%). Prespecified exploratory subgroup analysis conducted to evaluate the efficacy and safety of EVE+EXE versus PBO+EXE in a prospectively defined subgroup of patients with visceral metastases. At a median follow-up of 18 months, EVE+EXE significantly prolonged median PFS compared with PBO+EXE both in patients with visceral metastases (N=406; 6.8 versus 2.8 months) and in those without visceral metastases (N=318; 9.9 versus 4.2 months). Improvements in PFS with EVE+EXE versus PBO+EXE were also observed in patients with visceral metastases regardless of Eastern Cooperative Oncology Group performance status (ECOG PS). Patients with visceral metastases and ECOG PS 0 had a median PFS of 6.8 months with EVE+EXE versus 2.8 months with PBO+EXE. Among patients with visceral metastases and ECOG PS ≥1, EVE+EXE treatment more than tripled median PFS compared with PBO+EXE (6.8 versus 1.5 months). Adding EVE to EXE markedly extended PFS by ≥4 months among patients with HR(+) HER2(-) ABC regardless of the presence of visceral metastases. Copyright © 2013 The Authors. Published by Elsevier Ltd.. All rights reserved.

Phase 2 Study of Concurrent Cetuximab Plus Definitive Thoracic Radiation Therapy Followed by Consolidation Docetaxel Plus Cetuximab in Poor Prognosis or Elderly Patients With Locally Advanced Non-Small Cell Lung Cancer

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

Dilling, Thomas J.; Extermann, Martine; Kim, Jongphil

Background: Recursive partitioning analysis has shown that Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) ≥2, male sex, and age ≥70 years are prognostic of poor outcome in locally advanced non-small cell lung cancer (LA-NSCLC) patients. Concurrent chemoradiation therapy (CRT) improves survival, but toxicity is a concern in this frail patient cohort. We therefore opened this trial of concurrent definitive thoracic radiation therapy (XRT) and cetuximab, followed by consolidation docetaxel plus cetuximab. Methods and Materials: Eligible patients had pathologically proven, unresectable LA-NSCLC (stage IIA-“dry” IIIB). They had ECOG PS 2 or weight loss ≥5% in 3 months or were aged ≥70 years. Themore » primary objective was progression-free survival (PFS). Secondary objectives included overall survival (OS) and overall response rate (ORR). Results: From May 2008 to November 2010, a total of 32 patients were evaluated in our single-institution, institutional review board–approved prospective clinical trial. Three patients were screen failures and 2 more withdrew consent before treatment, leaving 27 evaluable patients. One was removed because of poor therapy compliance, and 2 were taken off trial because of grade 3 cetuximab-related toxicities but were followed up under intent-to-treat analysis. The median follow-up and OS were 10.5 months. The median PFS was 7.5 months. The ORR was 59.3%. Eight early/sudden deaths were reported. Upon review, 6 patients developed severe pulmonary complications. Conclusions: Patients enrolled in this trial had improved OS compared with poor-PS historical controls (10.5 vs 6.4 months) and comparable OS to good-PS historical controls (10.5 vs 11.9 months) treated with XRT alone. However, pulmonary toxicity is a concern. Consolidative cetuximab/docetaxel, in conjunction with high-dose radiation therapy, is a putative cause.« less

Pembrolizumab for advanced melanoma: experience from the Spanish Expanded Access Program.

PubMed

González-Cao, M; Arance, A; Piulats, J M; Marquez-Rodas, I; Manzano, J L; Berrocal, A; Crespo, G; Rodriguez, D; Perez-Ruiz, E; Berciano, M; Soria, A; Castano, A G; Espinosa, E; Montagut, C; Alonso, L; Puertolas, T; Aguado, C; Royo, M A; Blanco, R; Rodríguez, J F; Muñoz, E; Mut, P; Barron, F; Martin-Algarra, S

2017-06-01

The programmed death (PD-1) inhibitor pembrolizumab has been recently approved for the treatment of advanced melanoma. We evaluated the clinical activity of pembrolizumab in melanoma patients treated under the Spanish Expanded Access Program. Advanced melanoma patients who failed to previous treatment lines were treated with pembrolizumab 2 mg/kg every three weeks. Patients with brain metastases were not excluded if they were asymptomatic. Data were retrospectively collected from 21 centers in the Spanish Melanoma Group. Sixty-seven advanced melanoma patients were analyzed. Most patients were stage M1c (73.1%), had high LDH levels (55.2%) and had ECOG PS 1 or higher (59.7%). For cutaneous melanoma patients, median overall survival was 14.0 months; the 18-month overall survival rate was 47.1%. Overall response rate was 27%, including three patients with complete responses (6.5%). Median response duration was not reached, with 83.3% of responses ongoing (3.5 m+ to 20.4 m+). From ten patients included with brain metastases, four (40%) had an objective response, two (20%) of them achieved a complete response. Significant prognostic factors for overall survival were LDH level, ECOG PS and objective response. There were no serious adverse events. Although this was a heavily pretreated cohort, pembrolizumab activity at the approved dose and schedule was confirmed in the clinical setting with long-term responders, also including patients with brain metastases.

Impact of ferric carboxymaltose on the evolution of hemoglobin and ECOG performance status in iron-deficient patients with solid tumors: a 3-month follow-up retrospective study.

PubMed

Coussirou, J; Debourdeau, A; Stancu, A; Jean, C; Azouza, W; Chanet, B; De Crozals, F; Boustany, R; Debourdeau, P

2018-05-24

Anemia is often associated with a lower quality of life and less tolerance to treatments in cancer patients. The aims of this retrospective study were to assess the biological (hemoglobin, Hb) and clinical (ECOG index) impact of ferric carboxymaltose (FCM) and to identify predictive factors of response in cancer patients with iron deficiency. We included 133 patients with solid tumors who received at least one dose of FCM in 2015. At baseline, most patients had metastatic cancer (70%), were undergoing chemotherapy (82%), suffered from anemia (90%), and 72% had an ECOG 0-1 index. Mean Hb level was statistically higher at M1 (108.3 g/L ± 13.9), M2 (110.3 g/L ± 16.1), and M3 (111.7 g/L ± 12.6) than M0 (99.2 g/L ± 13.9). Mean ECOG score increased significantly at M1 (1.31 ± 0.80) and M2 (1.31 ± 0.87) compared to M0 (1.13 ± 0.80). Variations of ECOG index between M0 and M1 were independent of levels of Hb and ferritin at inclusion and pretreatment use of transfusion and ESAs. Increase of Hb level was higher in patients with Hb < 100 g/L, ferritinemia < 800 ng/ml, or transfused before inclusion. In multivariate analysis, an ECOG index of 0 was the only predictive factor of an increase of ECOG index and Hb level < 100 g/L and ferritinemia < 800 ng/ml were predictive of an increase in Hb. Even though there was no improvement in ECOG index, this study did identify an increase of Hb for patients receiving FCM, indicating its potential benefit in iron-deficient cancer patients.

Functional status and mortality prediction in community-acquired pneumonia.

PubMed

Jeon, Kyeongman; Yoo, Hongseok; Jeong, Byeong-Ho; Park, Hye Yun; Koh, Won-Jung; Suh, Gee Young; Guallar, Eliseo

2017-10-01

Poor functional status (FS) has been suggested as a poor prognostic factor in both pneumonia and severe pneumonia in elderly patients. However, it is still unclear whether FS is associated with outcomes and improves survival prediction in community-acquired pneumonia (CAP) in the general population. Data on hospitalized patients with CAP and FS, assessed by the Eastern Cooperative Oncology Group (ECOG) scale were prospectively collected between January 2008 and December 2012. The independent association of FS with 30-day mortality in CAP patients was evaluated using multivariable logistic regression. Improvement in mortality prediction when FS was added to the CRB-65 (confusion, respiratory rate, blood pressure and age 65) score was evaluated for discrimination, reclassification and calibration. The 30-day mortality of study participants (n = 1526) was 10%. Mortality significantly increased with higher ECOG score (P for trend <0.001). In multivariable analysis, ECOG ≥3 was strongly associated with 30-day mortality (adjusted OR: 5.70; 95% CI: 3.82-8.50). Adding ECOG ≥3 significantly improved the discriminatory power of CRB-65. Reclassification indices also confirmed the improvement in discrimination ability when FS was combined with the CRB-65, with a categorized net reclassification index (NRI) of 0.561 (0.437-0.686), a continuous NRI of 0.858 (0.696-1.019) and a relative integrated discrimination improvement in the discrimination slope of 139.8 % (110.8-154.6). FS predicted 30-day mortality and improved discrimination and reclassification in consecutive CAP patients. Assessment of premorbid FS should be considered in mortality prediction in patients with CAP. © 2017 Asian Pacific Society of Respirology.

Causes and prognostic factors for early death in patients with acute promyelocytic leukemia treated with single-agent arsenic trioxide.

PubMed

Hou, Jinxiao; Wang, Shuye; Zhang, Yingmei; Fan, Dachuan; Li, Haitao; Yang, Yiju; Ge, Fei; Hou, Wenyi; Fu, Jinyue; Wang, Ping; Zhao, Hongli; Sun, Jiayue; Yang, Kunpeng; Zhou, Jin; Li, Xiaoxia

2017-12-01

Early death (ED) is one of the most critical issues involved in the current care of patients with acute promyelocytic leukemia (APL). Factors identified as independent predictors of ED varied among published studies. We retrospectively analyzed the incidence, causes, and prognostic factors of ED in a series of 216 patients with newly diagnosed APL who received arsenic trioxide (ATO) as induction therapy. Multivariate logistic regression analysis was used to determine the association of clinical factors with overall ED, hemorrhagic ED, death within 7 days, and death within 8-30 days. In total, 35 EDs (16.2%) occurred that were caused by hemorrhage, differentiation syndrome (DS), infection, and other causes, in order of prevalence. The independent prognostic factors for overall ED and death within 8-30 days were the same and included serum creatinine level, Eastern Cooperative Oncology Group (ECOG) score, sex, and fibrinogen level. The risk factors for hemorrhagic ED and death within 7 days were similar and included serum creatinine level, ECOG score, and white blood cell count, while hemorrhagic ED was also associated with D-dimer. Our findings revealed a high rate of ED, and the causes of ED were similar to those among patients who received ATRA-based therapy. Increased creatinine level was the most powerful predictor, and an ECOG score greater than 2 was another strong prognostic factor for all four types of ED.

The influence of family adaptability and cohesion on anxiety and depression of terminally ill cancer patients.

PubMed

Park, Young-Yoon; Jeong, Young-Jin; Lee, Junyong; Moon, Nayun; Bang, Inho; Kim, Hyunju; Yun, Kyung-Sook; Kim, Yong-I; Jeon, Tae-Hee

2018-01-01

This study investigated the effect of family members on terminally ill cancer patients by measuring the relationship of the presence of the family caregivers, visiting time by family and friends, and family adaptability and cohesion with patient's anxiety and depression. From June, 2016 to March, 2017, 100 terminally ill cancer patients who were admitted to a palliative care unit in Seoul, South Korea, were surveyed, and their medical records were reviewed. The Korean version of the Family Adaptability and Cohesion Evaluation Scales III and Hospital Anxiety-Depression Scale was used. Chi-square and multiple logistic regression analyses were used. The results of the chi-square analysis showed that the presence of family caregivers and family visit times did not have statistically significant effects on anxiety and depression in terminally ill cancer patients. In multiple logistic regression, when adjusted for age, sex, ECOG PS, and the monthly average income, the odds ratios (ORs) of the low family adaptability to anxiety and depression were 2.4 (1.03-5.83) and 5.4 (1.10-26.87), respectively. The OR of low family cohesion for depression was 5.4 (1.10-27.20) when adjusted for age, sex, ECOG PS, and monthly average household income. A higher family adaptability resulted in a lower degree of anxiety and depression in terminally ill cancer patients. The higher the family cohesion, the lower the degree of depression in the patient. The presence of the family caregiver and the visiting time by family and friends did not affect the patient's anxiety and depression.

Chemotherapy Use, Performance Status, and Quality of Life at the End of Life

PubMed Central

Prigerson, Holly G.; Bao, Yuhua; Shah, Manish A.; Paulk, M. Elizabeth; LeBlanc, Thomas W.; Schneider, Bryan J.; Garrido, Melissa M.; Reid, M. Carrington; Berlin, David A.; Adelson, Kerin B.; Neugut, Alfred I.; Maciejewski, Paul K.

2016-01-01

IMPORTANCE Although many patients with end-stage cancer are offered chemotherapy to improve quality of life (QOL), the association between chemotherapy and QOL amid progressive metastatic disease has not been well-studied. American Society for Clinical Oncology guidelines recommend palliative chemotherapy only for solid tumor patients with good performance status. OBJECTIVE To evaluate the association between chemotherapy use and QOL near death (QOD) as a function of patients’ performance status. DESIGN, SETTING, AND PARTICIPANTS A multi-institutional, longitudinal cohort study of patients with end-stage cancer recruited between September 2002 and February 2008. Chemotherapy use (n = 158 [50.6%]) and Eastern Cooperative Oncology Group (ECOG) performance status were assessed at baseline (median = 3.8 months before death) and patients with progressive metastatic cancer (N = 312) following at least 1 chemotherapy regimen were followed prospectively until death at 6 outpatient oncology clinics in the United States. MAIN OUTCOMES AND MEASURES Patient QOD was determined using validated caregiver ratings of patients’ physical and mental distress in their final week. RESULTS Chemotherapy use was not associated with patient survival controlling for clinical setting and patients’ performance status. Among patients with good (ECOG score = 1) baseline performance status, chemotherapy use compared with nonuse was associated with worse QOD (odds ratio [OR], 0.35; 95% CI, 0.17-0.75; P = .01). Baseline chemotherapy use was not associated with QOD among patients with moderate (ECOG score = 2) baseline performance status (OR, 1.06; 95% CI, 0.51-2.21; P = .87) or poor (ECOG score = 3) baseline performance status (OR, 1.34; 95% CI, 0.46-3.89; P = .59). CONCLUSIONS AND RELEVANCE Although palliative chemotherapy is used to improve QOL for patients with end-stage cancer, its use did not improve QOD for patients with moderate or poor performance status and worsened QOD for patients with good performance status. The QOD in patients with end-stage cancer is not improved, and can be harmed, by chemotherapy use near death, even in patients with good performance status. PMID:26203912

Evaluation of the Glasgow Prognostic Score in patients receiving chemoradiotherapy for stage III and IV esophageal cancer.

PubMed

Kimura, J; Kunisaki, C; Makino, H; Oshima, T; Ota, M; Oba, M; Takagawa, R; Kosaka, T; Ono, H A; Akiyama, H; Endo, I

2016-11-01

High Glasgow Prognostic scores (GPSs) have been associated with poor outcomes in various tumors, but the values of GPS and modified GPS (mGPS) in patients with advanced esophageal cancer receiving chemoradiotherapy (CRT) has not yet been reported. We have evaluated these with respect to predicting responsiveness to CRT and long-term survival. Between January 2002 and December 2011, tumor responses in 142 esophageal cancer patients (131 men and 11 women) with stage III (A, B and C) and IV receiving CRT were assessed. We assessed the value of the GPS as a predictor of a response to definitive CRT and also as a prognostic indicator in patients with esophageal cancer receiving CRT. We found that independent predictors of CRT responsiveness were Eastern Cooperative Oncology Group (ECOG) performance status, GPS and cTNM stage. Independent prognostic factors were ECOG performance status and GPS for progression-free survival and ECOG performance status, GPS and cTNM stage IV for disease-specific survival. GPS may be a novel predictor of CRT responsiveness and a prognostic indicator for progression-free and disease-specific survival in patients with advanced esophageal cancer. However, a multicenter study as same regime with large number of patients will be needed to confirm these outcomes. © 2015 International Society for Diseases of the Esophagus.

Prognostic factors and risk stratification in patients with castration-resistant prostate cancer receiving docetaxel-based chemotherapy.

PubMed

Yamashita, Shimpei; Kohjimoto, Yasuo; Iguchi, Takashi; Koike, Hiroyuki; Kusumoto, Hiroki; Iba, Akinori; Kikkawa, Kazuro; Kodama, Yoshiki; Matsumura, Nagahide; Hara, Isao

2016-03-22

While novel drugs have been developed, docetaxel remains one of the standard initial systemic therapies for castration-resistant prostate cancer (CRPC) patients. Despite the excellent anti-tumor effect of docetaxel, its severe adverse effects sometimes distress patients. Therefore, it would be very helpful to predict the efficacy of docetaxel before treatment. The aims of this study were to evaluate the potential value of patient characteristics in predicting overall survival (OS) and to develop a risk classification for CRPC patients treated with docetaxel-based chemotherapy. This study included 79 patients with CRPC treated with docetaxel. The variables, including patient characteristics at diagnosis and at the start of chemotherapy, were retrospectively collected. Prognostic factors predicting OS were analyzed using the Cox proportional hazard model. Risk stratification for overall survival was determined based on the results of multivariate analysis. PSA response ≥50 % was observed in 55 (69.6 %) of all patients, and the median OS was 22.5 months. The multivariate analysis showed that age, serum PSA level at the start of chemotherapy, and Hb were independent prognostic factors for OS. In addition, ECOG performance status (PS) and the CRP-to-albumin ratio were not significant but were considered possible predictors for OS. Risk stratification according to the number of these risk factors could effectively stratify CRPC patients treated with docetaxel in terms of OS. Age, serum PSA level at the start of chemotherapy, and Hb were identified as independent prognostic factors of OS. ECOG PS and the CRP-to-albumin ratio were not significant, but were considered possible predictors for OS in Japanese CRPC patients treated with docetaxel. Risk stratification based on these factors could be helpful for estimating overall survival.

Who should be admitted to the intensive care unit? The outcome of intensive care unit admission in stage IIIB-IV lung cancer patients.

PubMed

Kim, Yu Jung; Kim, Mi-Jung; Cho, Young-Jae; Park, Jong Sun; Kim, Jin Won; Chang, Hyun; Lee, Jeong-Ok; Lee, Keun-Wook; Kim, Jee Hyun; Yoon, Ho Il; Bang, Soo-Mee; Lee, Jae Ho; Lee, Choon-Taek; Lee, Jong Seok

2014-03-01

Critical care for advanced lung cancer patients is still controversial, and the appropriate method for the selection of patients who may benefit from intensive care unit (ICU) care is not clearly defined. We retrospectively reviewed the medical records of stage IIIB-IV lung cancer patients admitted to the medical ICU of a university hospital in Korea between 2003 and 2011. Of 95 patients, 64 (67%) had Eastern Cooperative Oncology Group (ECOG) performance status (PS)≥2, and 79 (84%) had non-small-cell lung cancer. In total, 28 patients (30%) were newly diagnosed or were receiving first-line treatment, and 22 (23%) were refractory or bedridden. Mechanical ventilation was required in 85 patients (90%), and ICU mortality and hospital mortality were 57 and 78%, respectively. According to a multivariate analysis, a PaO2/FiO2 ratio<150 [odds ratio (OR)=5.51, 95% confidence interval (CI) 2.10-14.48, p=0.001] was independently associated with ICU mortality, and an ECOG PS≥2 (OR=9.53, 95% CI 2.03-44.85, p=0.004) and a need for vasoactive agents (OR=6.94, 95% CI 1.61-29.84, p=0.009) were independently associated with hospital mortality. Refractory or bedridden patients (n=22) showed significantly poorer overall survival (11.0 vs. 29.0 days, p=0.005). Among 21 patients who were discharged from the hospital, 11 (52%) received further chemotherapy. Certain advanced lung cancer patients may benefit from ICU management. However, refractory patients and patients with a poor PS do not seem to benefit from ICU care. Oncologists should try to discuss palliative care and end-of-life issues in advance to avoid futile care.

Superior long-term outcome with idarubicin compared with high-dose daunorubicin in patients with acute myeloid leukemia age 50 years and older.

PubMed

Gardin, Claude; Chevret, Sylvie; Pautas, Cécile; Turlure, Pascal; Raffoux, Emmanuel; Thomas, Xavier; Quesnel, Bruno; de Revel, Thierry; de Botton, Stéphane; Gachard, Nathalie; Renneville, Aline; Boissel, Nicolas; Preudhomme, Claude; Terré, Christine; Fenaux, Pierre; Bordessoule, Dominique; Celli-Lebras, Karine; Castaigne, Sylvie; Dombret, Hervé

2013-01-20

Although standard chemotherapy remains associated with a poor outcome in older patients with acute myeloid leukemia (AML), it is unclear which patients can survive long enough to be considered as cured. This study aimed to identify factors influencing the long-term outcome in these patients. The study included 727 older patients with AML (median age, 67 years) treated in two idarubicin (IDA) versus daunorubicin (DNR) Acute Leukemia French Association trials. Prognostic analysis was based on standard univariate and multivariate models and also included a cure fraction model to focus on long-term outcome. Age, WBC count, secondary AML, Eastern Cooperative Oncology Group (ECOG) performance status (PS), and adverse-risk and favorable-risk AML subsets (European LeukemiaNet classification) all influenced complete remission (CR) rate and overall survival (OS). IDA random assignment was associated with higher CR rate, but not with longer OS (P = .13). The overall cure rate was 13.3%. Older age and ECOG-PS more than 1 negatively influenced cure rate, which was higher in patients with favorable-risk AML (39.1% v 8.0% in adverse-risk AML; P < .001) and those treated with IDA (16.6% v 9.8% with DNR; P = .018). The long-term impact of IDA was still observed in patients younger than age 65 years, although all of the younger patients in the DNR control arm received high DNR doses (cure rate, 27.4% for IDA v 15.9% for DNR; P = .049). In multivariate analysis, IDA random assignment remained associated with a higher cure rate (P = .04), together with younger age and favorable-risk AML, despite not influencing OS (P = .11). In older patients with AML, younger age, favorable-risk AML, and IDA treatment predict a better long-term outcome.

Eligibility of real-world patients with chemo-refractory, K-RAS wild-type, metastatic colorectal cancer for palliative intent regorafenib monotherapy.

PubMed

Angeles, Arkhjamil; Hung, Wayne; Cheung, Winson Y

2018-06-23

The CORRECT trial demonstrated survival benefits with regorafenib monotherapy in patients with treatment-refractory, metastatic colorectal cancer (mCRC). However, the trial's stringent eligibility criteria for regorafenib may limit its external validity. We aimed to examine treatment attrition rates and eligibility for regorafenib in routine practice. We identified patients at the British Columbia Cancer Agency diagnosed with mCRC who demonstrated disease progression or intolerable toxicity on 2 or more lines of systemic therapy. During the study timeframe, panitumumab and cetuximab were only used in the chemo-refractory setting. Data on clinicopathologic variables and patient outcomes were ascertained and analyzed. Eligibility was determined using the CORRECT trial criteria. A total of 391 patients were identified, among whom only 39% were eligible for regorafenib: 35% in the panitumumab group and 51% in the cetuximab group. The main reasons for ineligibility in all patients were Eastern Cooperative Oncology Group Performance Status (ECOG PS) > 1 (69%), an elevated total bilirubin (21%), and thromboembolic events in the past 6 months (10%). No difference in eligibility for regorafenib was observed between patients previously receiving panitumumab or cetuximab (P = 0.914; 95% CI 0.550-1.951). Kaplan-Meier analyses showed that regorafenib-eligible compared to regorafenib-ineligible patients had an increased median overall survival of 5.3 versus 2.1 months, respectively (P < 0.001). However, Cox proportional hazard analyses showed that only ECOG PS rather than trial eligibility was correlated with outcomes. The strict eligibility criteria disqualify most patients with treatment-refractory mCRC for regorafenib therapy. Future trials should broaden the eligibility criteria to improve external validity.

The Assignment of American Society of Anesthesiologists Physical Status Classification for Adult Polytrauma Patients: Results From a Survey and Future Considerations.

PubMed

Kuza, Catherine M; Hatzakis, George; Nahmias, Jeffry T

2017-12-01

The American Society of Anesthesiologists (ASA) physical status (PS) classification system assesses the preoperative health of patients. Previous studies demonstrated poor interrater reliability and variable ASA PS scores, especially in trauma scenarios. There are few studies that evaluated the assignment of ASA PS scores in trauma patients and no studies that evaluated ASA PS assignment in severely injured adult polytrauma patients. Our objective was to assess interrater reliability and identify sources of discrepancy among anesthesiologists and trauma surgeons in designating ASA PS scores to adult polytrauma patients. A link to an online survey containing questions assessing attitudes regarding ASA PS classification, demographic information, and 8 fictional trauma cases was e-mailed to anesthesiologists and trauma surgeons. The participants were asked to assign an ASA PS score to each scenario and explain their choice. Rater-versus-reference and interrater reliability, beyond that expected by chance, among respondents was analyzed using the Fleiss kappa analysis. A total of 349 participants completed the survey. All 8 cases had inconsistent ASA PS scores; several cases had scores ranging from I to VI and variable emergency (E) designations. Using weighted kappa (Kw) analysis for a subset of 201 respondents (101 trauma surgeons [S] and 100 anesthesiologists [A]), we found moderate (Kw = 0.63; SE = 0.024; 95% confidence interval, 0.594-0.666; P < .001) interrater-versus-reference reliability. The interrater reliability was fair (Kw = 0.43; SE = 0.037; 95% confidence interval, 0.360-0.491; P < .001). This study demonstrates fair interrater reliability beyond that expected by chance of the ASA PS scores among anesthesiologists and trauma surgeons when assessing adult polytrauma patients. Although the ASA PS is used in some trauma risk stratification models, discrepancies of ASA PS scores assigned to trauma cases exist. Future modifications of the ASA PS guidelines should aim to improve the interrater reliability of ASA PS scores in trauma patients. Further studies are warranted to determine the value of the ASA PS score as a trauma prognostic metric.

Everyday Cognition in Prodromal Huntington Disease

PubMed Central

Williams, Janet K.; Kim, Ji-In; Downing, Nancy; Farias, Sarah; Harrington, Deborah L.; Long, Jeffrey D.; Mills, James A.; Paulsen, Jane S.

2014-01-01

Objective Assessment of daily functions affected by cognitive loss in prodromal Huntington disease (HD) is necessary in practice and clinical trials. We evaluated baseline and longitudinal sensitivity of the Everyday Cognition (ECog) scales in prodromal HD and compared self- and companion-ratings. Method Everyday cognition was self-assessed by 850 participants with prodromal HD and 768 companions. We examined internal structure using confirmatory factor analysis (CFA) on baseline data. For longitudinal analysis, we stratified participants into Low, Medium, and High disease progression groups. We examined ECog scores for group differences and participant-and-companion differences using linear mixed effects regression (LMER). Comparison with the Total Functional Capacity (TFC) scale was made. Results CFA revealed good fit of a 5-factor model having a global factor (total score), and sub factors (subscales) of memory, language, visuospatial perception, and executive function. At study entry, participants and companions in the Medium and High groups reported significantly worsened everyday cognition as well as significant functional decline over time. Losses became more pronounced and participant and companion ratings diverged as individuals progressed. TFC showed significant functional loss over time in the High group but not in the Medium group. Conclusions Disease progression is associated with reduced self- and companion-reported everyday cognition in prodromal HD participants who are less than 13 years to estimated motor onset. Our findings suggest companion ratings are more sensitive than participants’ for detecting longitudinal change in daily cognitive function. ECog appears more sensitive to specific functional changes in the prodrome of HD than the TFC. PMID:25000321

Utility of a patient-reported outcome in measuring functional impairment during autologous stem cell transplant in patients with multiple myeloma.

PubMed

Shah, Nina; Shi, Qiuling; Giralt, Sergio; Williams, Loretta; Bashir, Qaiser; Qazilbash, Muzaffar; Champlin, Richard E; Cleeland, Charles S; Wang, Xin Shelley

2018-04-01

We aimed to determine the utility of a patient-reported outcome (PRO) as it relates to patient performed testing (PPT) for measuring functional status in multiple myeloma patients after autologous hematopoietic stem cell transplantation (auto-HCT). Symptom interference on walking (a PRO) was measured by the MD Anderson Symptom Inventory (MDASI). PPT was assessed via 6-min walk test (6MWT). Mixed effects modeling was used to examine (1) the longitudinal relationship between the MDASI score and 6MWT distance and (2) the MDASI scores between patients who did or did not complete the 6WMT. Receiver operating characteristic (ROC) curve analysis was performed to quantify the construct validity of the PRO by differentiating performance status. Seventy-nine patients were included. Mean 6MWT distance significantly correlated with MDASI-walking interference score (PRO) over the first month of auto-HCT (est = 6.09, p = 0.006). There was a significantly higher completion rate for MDASI versus 6MWT at each time point (p < 0.01). Patients who completed the 6MWT reported less interference on walking during the study period (est = 1.61, p < 0.0001). Finally, the PRO demonstrated significant construct validity for measuring functioning status with MDASI-walking against ECOG-PS as the anchor (AUC = 0.77, 95% CI 0.60-0.94, p = 0.003). The PRO of MDASI-walking interference is a valid physical functioning measure, correlating with an objective functional measure (6MWT) in MM patients undergoing auto-HCT. As patients with poorer functional status during therapy are less likely to complete PPT, this PRO may offer a more practical quantitative measure of functioning in patients.

Prognostic model of survival for typical bronchial carcinoid tumours: analysis of 1109 patients on behalf of the European Association of Thoracic Surgeons (ESTS) Neuroendocrine Tumours Working Group.

PubMed

Filosso, Pier Luigi; Guerrera, Francesco; Evangelista, Andrea; Welter, Stefan; Thomas, Pascal; Casado, Paula Moreno; Rendina, Erino Angelo; Venuta, Federico; Ampollini, Luca; Brunelli, Alessandro; Stella, Franco; Nosotti, Mario; Raveglia, Federico; Larocca, Valentina; Rena, Ottavio; Margaritora, Stefano; Ardissone, Francesco; Travis, William D; Sarkaria, Inderpal; Sagan, Dariusz

2015-09-01

Typical carcinoids (TCs) are uncommon, slow-growing neoplasms, usually with high 5-year survival rates. As these are rare tumours, their management is still based on small clinical observations and no international guidelines exist. Based on the European Society of Thoracic Surgeon Neuroendocrine Tumours Working Group (NET-WG) Database, we evaluated factors that may influence TCs mortality. Using the NET-WG database, an analysis on TC survival was performed. Overall survival (OS) was calculated starting from the date of intervention. Predictors of OS were investigated using the Cox model with shared frailty (accounting for the within-centre correlation). Candidate predictors were: gender, age, smoking habit, tumour location, previous malignancy, Eastern Cooperative Oncology Group (ECOG) performance status (PS), pT, pN, TNM stage and tumour vascular invasion. The final model included predictors with P ≤ 0.15 after a backward selection. Missing data in the evaluated predictors were multiple-imputed and combined estimates were obtained from five imputed data sets. For 58 of 1167 TC patients vital status was unavailable and analyses were therefore performed on 1109 patients from 17 institutions worldwide. During a median follow-up of 50 months, 87 patients died, with a 5-year OS rate of 93.7% (95% confidence interval: 91.7-95.3). Backward selection resulted in a prediction model for mortality containing age, gender, previous malignancies, peripheral tumour, TNM stage and ECOG PS. The final model showed a good discrimination ability with a C-statistic equal to 0.836 (bootstrap optimism-corrected 0.806). We presented and validated a promising prognostic model for TC survival, showing good calibration and discrimination ability. Further analyses are needed and could be focused on an external validation of this model. © The Author 2015. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.

Cisplatin- Versus Non-Cisplatin-based First-Line Chemotherapy for Advanced Urothelial Carcinoma Previously Treated With Perioperative Cisplatin.

PubMed

Locke, Jennifer A; Pond, Gregory Russell; Sonpavde, Guru; Necchi, Andrea; Giannatempo, Patrizia; Paluri, Ravi Kumar; Niegisch, Guenter; Albers, Peter; Buonerba, Carlo; Di Lorenzo, Giuseppe; Vaishampayan, Ulka N; North, Scott A; Agarwal, Neeraj; Hussain, Syed A; Pal, Sumanta; Eigl, Bernhard J

2016-08-01

The optimal choice of first-line chemotherapy for patients with relapse of urothelial carcinoma (UC) after perioperative cisplatin-based chemotherapy (PCBC) is unclear. We investigated the outcomes with cisplatin rechallenge versus a non-cisplatin regimen in patients with recurrent metastatic UC after PCBC in a multicenter retrospective study. Individual patient-level data were collected for patients who had received various first-line chemotherapy regimens for advanced UC after previous PCBC. Cox proportional hazards models were used to investigate the prognostic ability of the type of perioperative and first-line chemotherapy to independently affect overall survival (OS) and progression-free survival (PFS) after accounting for known prognostic factors. Data were available for 145 patients (12 centers). The mean age was 62 years; the Eastern Cooperative Oncology Group (ECOG) performance status (PS) was > 0 for 42.0% of the patients. Of the 145 patients, 63% had received cisplatin-based first-line chemotherapy. The median time from previous chemotherapy (TFPC) was 6.2 months (range, 1-154 months). The median OS was 22 months (95% confidence interval [CI], 18-27 months), and the median PFS was 6 months (95% CI, 5-7 months). A better ECOG PS and a longer TFPC (> 12 months vs. ≤ 12 months; hazard ratio [HR], 0.32; 95% CI, 0.20-0.52; P < .001) was prognostic for OS and PFS. Cisplatin-based chemotherapy was associated with poor OS (HR, 1.86; 95% CI, 1.13-3.06; P = .015), which appeared to be pronounced in those patients with a TFPC of ≤ 12 months. Retreatment with cisplatin in the first-line setting was associated with worse OS (HR, 3.38; P < .001). The results of the present retrospective analysis suggest that for patients who have undergone previous PCBC for UC, rechallenging with cisplatin might confer a poorer OS, especially for those with progression within < 1 year. Copyright © 2015 Elsevier Inc. All rights reserved.

Pembrolizumab in Asia-Pacific patients with advanced head and neck squamous cell carcinoma: Analyses from KEYNOTE-012.

PubMed

Tahara, Makoto; Muro, Kei; Hasegawa, Yasuhisa; Chung, Hyun Cheol; Lin, Chia-Chi; Keam, Bhumsuk; Takahashi, Kenichi; Cheng, Jonathan D; Bang, Yung-Jue

2018-03-01

KEYNOTE-012 was a phase Ib, multicohort study designed to investigate efficacy and safety of pembrolizumab in advanced solid tumors. Results from the subset of patients with recurrent/metastatic head and neck squamous cell carcinoma (HNSCC) from the Asia-Pacific region are reported. Patients with recurrent/metastatic HNSCC, measurable disease (RECIST version 1.1), and ECOG performance status (PS) 0-1 were eligible for enrollment in the HNSCC expansion cohort. Patients received pembrolizumab 200 mg every 3 weeks. Response was assessed every 8 weeks. Co-primary end-points were safety and overall response rate (RECIST version 1.1, central review). Secondary end-points included overall survival and response duration. Patients enrolled at any of the five centers throughout the Asia-Pacific region were included in these analyses. Twenty-six patients with HNSCC from the Asia-Pacific region received pembrolizumab. The median age was 62 years, 65% of patients had ECOG PS 1, and 62% had received two or more prior therapies for recurrent/metastatic disease. Sixteen (62%) patients experienced a treatment-related adverse event of any grade, including two (8%) patients who experienced one or more events of grade 3 severity. No treatment-related deaths occurred. The overall response rate was 19% (95% confidence interval, 7%-39%). After a median follow-up of 12 months (range, 2-21 months), a median response duration was not reached (range, 6 to 17+ months); four of five responses lasted ≥6 months. Median overall survival was 11.6 months (95% confidence interval, 4.7-17.7 months). Pembrolizumab was well tolerated and had durable antitumor activity in patients with HNSCC from the Asia-Pacific region. (Trial registration no. NCT01848834.). © 2017 The Authors. Cancer Science published by John Wiley & Sons Australia, Ltd on behalf of Japanese Cancer Association.

Real-life experience of ceritinib in crizotinib-pretreated ALK+ advanced non-small cell lung cancer patients.

PubMed

Cadranel, Jacques; Cortot, Alexis B; Lena, Hervé; Mennecier, Bertrand; Do, Pascal; Dansin, Eric; Mazieres, Julien; Chouaid, Christos; Perol, Maurice; Barlesi, Fabrice; Robinet, Gilles; Friard, Sylvie; Thiberville, Luc; Audigier-Valette, Clarisse; Vergnenegre, Alain; Westeel, Virginie; Slimane, Khemaies; Buturuga, Alexandru; Moro-Sibilot, Denis; Besse, Benjamin

2018-01-01

Here we report our experience of ceritinib in crizotinib-pretreated patients with anaplastic lymphoma kinase ( ALK ) positive ( ALK + ) non-small cell lung cancer (NSCLC) in a French temporary authorisation for use (TAU) study. The French TAU study included crizotinib-pretreated patients with advanced ALK + or ROS proto-oncogene 1 positive ( ROS1 + ) tumours. Patients received oral ceritinib (750 mg·day -1 as a starting dose) and best tumour response (as evaluated by the investigator) and safety were reported every 3 months. A total of 242 TAUs were granted from March 12, 2013 to August 05, 2015. Of the 242 patients, 228 had ALK + NSCLC and 13 had ROS1 + NSCLC. The median age of ALK + patients (n=214) was 58.5 years, 51.9% were female, 70.8% had an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-1 and 50.0% had brain metastases. Of the 149 efficacy evaluable ALK + NSCLC patients, 5.4% had a complete response (CR), 47.0% had a partial response (PR) and 22.8% had stable disease (SD). At September 05, 2015, the median duration of ceritinib treatment (n=182) was 3.9 months but 5.5 months for patients (n=71) with a follow-up of ≥12 months. Higher objective response rate (ORR) was observed for patients with ECOG PS 0 to 1 (55.0% versus 42.4%) and those receiving prior crizotinib for >5 months (51.6% versus 36.1%). Treatment-related adverse events (AEs) were reported in 118 of 208 patients (56.7%), the most common being diarrhoea (22.1%) and hepatic toxicity (19.7%). Ceritinib (750 mg·day -1 ) demonstrated efficacy similar efficacy to ASCEND-1, ASCEND-2 and phase 3 ASCEND-5 trials with manageable safety in crizotinib-pretreated patients with ALK + NSCLC.

Pembrolizumab Utilization and Outcomes for Advanced Melanoma in US Community Oncology Practices

PubMed Central

Liu, Frank Xiaoqing; Black-Shinn, Jenny; Stevinson, Kendall; Boyd, Marley; Frytak, Jennifer R.; Ebbinghaus, Scot W.

2018-01-01

The programmed death-1 inhibitor pembrolizumab has demonstrated efficacy and safety in clinical trials for treating advanced (unresectable/metastatic) melanoma. We investigated the real-world utilization of pembrolizumab and associated patient outcomes for advanced melanoma in US community oncology practices. This retrospective, observational study used deidentified data from electronic health records for adult patients with advanced melanoma who received pembrolizumab at The US Oncology Network sites from September 2014 through December 2015, with follow-up through September 2016. Patients enrolled in clinical trials were excluded. Overall survival (OS) and physician-stated progression-free survival (PFS) were analyzed from pembrolizumab initiation using Kaplan-Meier, and associations between pembrolizumab therapy and OS/PFS, using multivariable Cox regression. Of 168 patients studied, 110 (65%) were male; the median age was 66 years (range, 26–over 90). Pembrolizumab was prescribed as first-line, second-line, and third-line/later for 39 (23%), 87 (52%), and 42 (25%) patients, respectively. In total, 41 patients (24%) had brain metastases. At pembrolizumab initiation, 21/129 (16%) had Eastern Cooperative Oncology Group performance status (ECOG PS) >1; 51/116 (44%) had elevated lactate dehydrogenase. Median follow-up was 10.5 months (range, 0–25.1); median OS was 19.4 months (95% confidence interval, 14.0–not reached); median PFS was 4.2 months (95% confidence interval, 2.9–5.3). Brain metastases, ECOG PS>1, elevated lactate dehydrogenase, and third-line/later (vs. first-line) pembrolizumab were significant predictors (P<0.01) of decreased survival. Treatment-related toxicity was a discontinuation reason for 25% (29/117) of patients, and for 10 of these 29 patients (6% of the full-study cohort) treatment-related toxicity was the only reported reason. The real-world effectiveness and safety of pembrolizumab for advanced melanoma are consistent with clinical trial findings. PMID:29252916

On the necessity of new decision-making methods for cancer-associated, symptomatic, pulmonary embolism.

PubMed

Carmona-Bayonas, A; Font, C; Jiménez-Fonseca, P; Fenoy, Francisco; Otero, R; Beato, C; Plasencia, J; Biosca, M; Sánchez, M; Benegas, M; Calvo-Temprano, D; Varona, D; Faez, L; Vicente, M A; de la Haba, I; Antonio, M; Madridano, O; Ramchandani, A; Castañón, E; Marchena, P J; Martínez, M J; Martín, M; Marín, G; Ayala de la Peña, F; Vicente, V

2016-07-01

Acute symptomatic pulmonary embolism (PE) varies in its clinical manifestations in patients with cancer and entails specific issues. The objective is to assess the performance of five scores (PESI, sPESI, GPS, POMPE, and RIETE) and a clinical decision rule to predict 30-day mortality. This is an ambispective, observational, multicenter study that collected episodes of PE in patients with cancer from 13 Spanish centers. The main criterion for comparing scales was the c-indices and 95% confidence intervals (CIs) of the models for predicting 30-day mortality. 585 patients with acute symptomatic PE were recruited. The 30-day mortality rate was 21.3 (95% CI; 18.2-24.8%). The specific scales (POMPE-C and RIETE) were equally effective in discriminating prognosis (c-index of 0.775 and 0.757, respectively). None of these best performing scales was superior to the ECOG-PS with a c-index of 0.724. The remaining scores (PESI, sPESI, and GPS) performed worse, with c-indexes of 0.719, 0.705, and 0.722, respectively. The dichotomic "clinical decision rule" for ambulatory therapy was at least equally reliable in defining a low risk group: in the absence of all exclusion criteria, 30-day mortality was 2%, compared to 5% and 4% in the POMPE-C and RIETE low-risk categories, respectively. The accuracy of the five scales examined was not high enough to rely on to predict 30-day mortality and none of them contribute significantly to qualitative clinical judgment. Copyright © 2016 Elsevier Ltd. All rights reserved.

An electrocorticographic electrode array for simultaneous recording from medial, lateral, and intrasulcal surface of the cortex in macaque monkeys.

PubMed

Fukushima, Makoto; Saunders, Richard C; Mullarkey, Matthew; Doyle, Alexandra M; Mishkin, Mortimer; Fujii, Naotaka

2014-08-15

Electrocorticography (ECoG) permits recording electrical field potentials with high spatiotemporal resolution over a large part of the cerebral cortex. Application of chronically implanted ECoG arrays in animal models provides an opportunity to investigate global spatiotemporal neural patterns and functional connectivity systematically under various experimental conditions. Although ECoG is conventionally used to cover the gyral cortical surface, recent studies have shown the feasibility of intrasulcal ECoG recordings in macaque monkeys. Here we developed a new ECoG array to record neural activity simultaneously from much of the medial and lateral cortical surface of a single hemisphere, together with the supratemporal plane (STP) of the lateral sulcus in macaque monkeys. The ECoG array consisted of 256 electrodes for bipolar recording at 128 sites. We successfully implanted the ECoG array in the left hemisphere of three rhesus monkeys. The electrodes in the auditory and visual cortex detected robust event related potentials to auditory and visual stimuli, respectively. Bipolar recording from adjacent electrode pairs effectively eliminated chewing artifacts evident in monopolar recording, demonstrating the advantage of using the ECoG array under conditions that generate significant movement artifacts. Compared with bipolar ECoG arrays previously developed for macaque monkeys, this array significantly expands the number of cortical target areas in gyral and intralsulcal cortex. This new ECoG array provides an opportunity to investigate global network interactions among gyral and intrasulcal cortical areas. Published by Elsevier B.V.

Comprehensive Geriatric Assessment (CGA) based risk factors for increased caregiver burden among elderly Asian patients with cancer.

PubMed

Rajasekaran, Tanujaa; Tan, Tira; Ong, Whee Sze; Koo, Khai Nee; Chan, Lili; Poon, Donald; Roy Chowdhury, Anupama; Krishna, Lalit; Kanesvaran, Ravindran

2016-05-01

This study aims to identify Comprehensive Geriatric Assessment (CGA) based risk factors to help predict caregiver burden among elderly patients with cancer. The study evaluated 249 patients newly diagnosed with cancer, aged 70years and above, who attended the geriatric oncology clinic at the National Cancer Centre Singapore between 2007 and 2010. Out of 249 patients, 244 patients had information available on family caregiver burden and were analysed. On univariate analysis, ADL dependence, lower IADL scores, ECOG performance status of 3-4, higher fall risk, lower scores in dominant hand grip strength test and mini mental state examination, polypharmacy, higher nutritional risk, haemoglobin <12g/dL and presence of geriatric syndromes were significantly associated with mild to severe caregiver burden. On multivariate analysis, only ECOG performance status of 3-4 (odds ratio [OR], 4.47; 95% confidence interval [CI], 2.27-8.80) and haemoglobin <12g/dL (OR, 2.38; 95% CI, 1.14-4.99) were associated with an increased probability of mild to severe caregiver burden. The model achieved a good fit (Hosmer-Lemeshow's p=0.196) and discrimination (area under the curve [AUC]=0.742; bias-corrected AUC=0.737). Based on this, patients were stratified into 3 risk groups with different proportion of patients with increased caregiver burden (low risk: 3.9% vs intermediate risk: 18.8% vs high risk: 39.6%; p<0.001). ECOG performance status and haemoglobin were associated with increased caregiver burden among elderly patients with cancer. Using these two factors in the clinic may help clinicians identify caregivers at risk and take preventive action to mitigate that. Copyright © 2016 Elsevier Inc. All rights reserved.

Improvement in pain after lumbar surgery in cancer patients with mechanical radiculopathy.

PubMed

Moliterno, Jennifer; Veselis, Clinton A; Hershey, Michael A; Lis, Eric; Laufer, Ilya; Bilsky, Mark H

2014-10-01

Lumbar metastases can result in spinal instability and mechanical radiculopathy, characterized by radicular pain produced by axial loading. This pain pattern represents a definitive symptom of neoplastic instability and may serve as a reliable indication for surgical stabilization. We examined the results of surgical decompression and fixation in the treatment of mechanical radiculopathy. A retrospective clinical study. An internally maintained spine neurosurgery database was queried between February 2002 and April 2010. Patients were identified and deemed eligible for inclusion in this study based on the presence of all the following: metastatic tumor, lumbar surgery, and lumbar radiculopathy. Visual analog scale (VAS) of pain and Eastern Cooperative Oncology Group (ECOG) status. The Memorial Sloan-Kettering Cancer Center Department of Neurosurgery operative database was queried over an 8-year period to identify all patients with spinal metastases who underwent lumbar surgery. Only patients whose operative indication included mechanical radiculopathy were included. Pre- and postoperative pain was assessed with the VAS of pain, whereas pre- and postoperative performance status was evaluated using the ECOG. Fifty-five patients were included in the cohort. L2 and L3 were the most common levels involved, and most patients underwent multilevel posterior decompression and instrumented fusion. After surgery, 98% of patients reported pain relief. A significant difference between average pre- and postoperative pain scores was found (p<.01). Overall, 41.5% of patients experienced improvement in their ECOG score postoperatively. Mechanical radiculopathy in patients with spinal metastases represents a highly reliable surgical indication. Spinal decompression and fixation is an effective treatment for pain palliation in this patient population. Copyright © 2014 Elsevier Inc. All rights reserved.

Gemcitabine and capecitabine as third- or later-line therapy for refractory advanced colorectal cancer: a retrospective study.

PubMed

Salgado, Mercedes; Reboredo, Margarita; Mendez, Juan Carlos; Quintero, Guillermo; Pellón, María Luz; Romero, Carlos; Jorge, Mónica; Montes, Ana Fernández; Valladares-Ayerbes, Manuel; Ramos, Manuel; Varela, Silvia; Alonso, Miguel Ángel

2013-09-01

To evaluate gemcitabine plus capecitabine as third-line or later-line therapy in patients with refractory advanced colorectal cancer (CRC) who maintain a good performance status (PS). We retrospectively evaluated patients who had failed at least two lines of therapy or had contraindication to standard therapy and received gemcitabine (1,000 mg/m(2), d1 biweekly) plus capecitabine (1,700 mg/m(2)/day, d1-7 every two weeks) in a compassionate use program. Thirty-nine patients were enrolled. The majority (85%) had ECOG PS 1. Gemcitabine plus capecitabine was administered as third- and fourth-line in 49% and 23% of patients, respectively; and as fifth-line or later-line in 28%. A clinical benefit of 21% was found. The median progression-free survival and overall survival were 3.0 and 7.3 months, respectively. Toxicity was mild to moderate, with no reported grade 4 toxicities. Gemcitabine plus capecitabine was safe and well-tolerated. While the efficacy of this regimen was modest in terms of response, the survival data were acceptable and consistent with previous publications on this setting.

Variability in the American Society of Anesthesiologists Physical Status Classification Scale.

PubMed

Aronson, Wendy L; McAuliffe, Maura S; Miller, Ken

2003-08-01

The American Society of Anesthesiologists (ASA) Physical Status (PS) Classification is used worldwide by anesthesia providers as an assessment of the preoperative physical health of patients. This score also has been used in policy-making, performance evaluation, resource allocation, and reimbursement of anesthesia services and frequently is cited in clinical research. The purpose of this study was to assess interrater reliability and describe sources of variability among anesthesia providers in assigning ASA PS scores. A questionnaire with 10 hypothetical patients scenarios was given to 70 anesthesia providers who were asked to assign ASA PS scores in each scenario and to provide rationale for their decisions. The data were summarized and stratified according to nurse anesthetist or anesthesiologist and military or nonmilitary anesthesia providers. We hypothesized there would be no difference between any of the anesthesia provider groups in assignment of ASA PS scores. A lack of interrater reliability in assigning ASA PS scores was demonstrated. There were no significant differences between the anesthesia provider groups. There was no correlation between ASA PS scoring and years practicing or any of the other demographic variables. Several sources of variability were identified: smoking, pregnancy, nature of the surgery, potential difficult airway, and acute injury.

An electrocorticographic electrode array for simultaneous recording from medial, lateral, and intrasulcal surface of the cortex in macaque monkeys

PubMed Central

Fukushima, Makoto; Saunders, Richard C.; Mullarkey, Matthew; Doyle, Alexandra M.; Mishkin, Mortimer; Fujii, Naotaka

2014-01-01

Background Electrocorticography (ECoG) permits recording electrical field potentials with high spatiotemporal resolution over a large part of the cerebral cortex. Application of chronically implanted ECoG arrays in animal models provides an opportunity to investigate global spatiotemporal neural patterns and functional connectivity systematically under various experimental conditions. Although ECoG is conventionally used to cover the gyral cortical surface, recent studies have shown the feasibility of intrasulcal ECoG recordings in macaque monkeys. New Method Here we developed a new ECoG array to record neural activity simultaneously from much of the medial and lateral cortical surface of a single hemisphere, together with the supratemporal plane (STP) of the lateral sulcus in macaque monkeys. The ECoG array consisted of 256 electrodes for bipolar recording at 128 sites. Results We successfully implanted the ECoG array in the left hemisphere of three rhesus monkeys. The electrodes in the auditory and visual cortex detected robust event related potentials to auditory and visual stimuli, respectively. Bipolar recording from adjacent electrode pairs effectively eliminated chewing artifacts evident in monopolar recording, demonstrating the advantage of using the ECoG array under conditions that generate significant movement artifacts. Comparison with Existing Methods Compared with bipolar ECoG arrays previously developed for macaque monkeys, this array significantly expands the number of cortical target areas in gyral and intralsulcal cortex. Conclusions This new ECoG array provides an opportunity to investigate global network interactions among gyral and intrasulcal cortical areas. PMID:24972186

Dabrafenib in metastatic melanoma: a monocentric ‘real life’ experience

PubMed Central

Cocorocchio, E; Gandini, S; Alfieri, S; Battaglia, A; Pennacchioli, E; Tosti, G; Spadola, G; Barberis, M; Leo, M Di; Riviello, C; Pala, L; Intelisano, A; Martinoli, C; Ferrucci, PF

2016-01-01

Dabrafenib is a potent BRAF-kinase inhibitor. Its activity was evaluated on 40 consecutive metastatic melanoma patients (pts) harboring the V600BRAF mutations. Dabrafenib was administered orally at the dosage of 150 mg b.i.d. daily. ORR was 82%, with 7% CR, 62% PR, 13% SD and 18% PD. The median PFS and OS were seven and 17 months, respectively (median follow-up: 8.5 months). Increased risk of progression was found in pts with elevated LDH, ECOG PS >1 and more than two metastatic sites. Grade 3–4 adverse events were recorded in 4 pts. In this retrospective analysis, Dabrafenib confirmed its role as the standard clinical option in metastatic melanoma pts. PMID:26981153

ECoG sleep-waking rhythms and bodily activity in the cerveau isolé rat.

PubMed

Nakata, K; Kawamura, H

1986-01-01

In rats with a high mesencephalic transection, isolating both the locus coeruleus and raphe nuclei from the forebrain, Electrocorticogram (ECoG) and Electromyogram (EMG) of the neck muscles were continuously recorded. Normal sleep-waking ECoG changes with a significant circadian rhythm reappeared in 4 to 9 days after transection. Neck muscle EMG and bodily movements were independent of the ECoG changes and did not show any significant circadian rhythm. In these high mesencephalic rats with sleep-waking ECoG changes, large bilateral hypothalamic lesions were made by passing DC current either in the preoptic area or in the posterior hypothalamus. After the preoptic area lesions the amount of low voltage fast ECoG per day markedly increased, whereas after the posterior hypothalamic lesions, the total amount of low voltate fast wave per day decreased showing long-lasting slow wave sleep pattern. These results support an idea that the forebrain, especially in the hypothalamus including the preoptic area, a mechanism inducing sleep-waking ECoG changes is localized.

The use of plaque score measurements to assess changes in atherosclerotic plaque burden induced by lipid-lowering therapy over time: the METEOR study.

PubMed

Peters, Sanne A E; Dogan, Soner; Meijer, Rudy; Palmer, Mike K; Grobbee, Diederick E; Crouse, John R; O'Leary, Daniel H; Evans, Gregory W; Raichlen, Joel S; Bots, Michiel L

2011-01-01

To evaluate whether plaque scoring measurements are able to track changes in atherosclerotic plaque burden over time and to study whether this is affected by lipid-lowering therapy. Data used were from METEOR (Measuring Effects on Intima-Media Thickness: an Evaluation Of Rosuvastatin), a randomized controlled trial of rosuvastatin 40 mg among 984 low-risk patients with modest carotid intima-media thickening (CIMT). In this analysis, duplicate ultrasound images from 12 carotid sites were collected at the baseline and end of the study from 495 European patients and were evaluated for plaque presence and severity. Plaques were scored from near and far walls of the 12 sites (0= none; 1= minimal; 2= moderate; 3= severe) and plaque scores (PS) were combined into two summary measures for each examination. The MeanMaxPS is the mean over the 12 carotid sites of the maximum score at each site and the MaxMaxPS reflects the most severe lesion at any site. Baseline MeanMaxPS and MaxMaxPS were 0.31 (SD: 0.20) and 1.15 (SD: 0.51), respectively. Changes in MeanMaxPS and MaxMaxPS significantly differed between rosuvastatin and placebo (mean difference: -0.03 [SE: 0.01; p =0.016] and -0.09 [SE: 0.04; p =0.027], respectively). In contrast to rosuvastatin, which demonstrated no change from the baseline, placebo showed significant progression in MeanMaxPS and MaxMaxPS (p =0.002; both). The plaque-scoring method proved capable of assessing the change in atherosclerotic plaque burden over time and proved useful to evaluate lipid-lowering in asymptomatic individuals with a low risk of cardiovascular disease and subclinical atherosclerosis.

Relationship between physician and patient assessment of performance status and survival in a large cohort of patients with haematologic malignancies.

PubMed

Liu, Michael A; Hshieh, Tammy; Condron, Nolan; Wadleigh, Martha; Abel, Gregory A; Driver, Jane A

2016-09-27

Few studies have investigated the relationship between physician and patient-assessed performance status (PS) in blood cancers. Retrospective analysis among 1418 patients with haematologic malignancies seen at Dana-Farber Cancer Institute between 2007 and 2014. We analysed physician-patient agreement of Eastern Cooperative Oncology Group PS using weighted κ-statistics and survival analysis. Mean age was 58.6 years and average follow-up was 38 months. Agreement in PS was fair/moderate (weighted κ=0.41, 95% CI 0.37-0.44). Physicians assigned a better functional status (lower score) than patients (mean 0.60 vs 0.81), particularly when patients were young and the disease was aggressive. Both scores independently predicted survival, but physician scores were more accurate. Disagreements in score were associated with poorer survival when physicians rated PS better than patients, and were modified by age, sex and severity of disease. Physician-patient disagreements in PS score are common and have prognostic significance.

[Propensity score matching in SPSS].

PubMed

Huang, Fuqiang; DU, Chunlin; Sun, Menghui; Ning, Bing; Luo, Ying; An, Shengli

2015-11-01

To realize propensity score matching in PS Matching module of SPSS and interpret the analysis results. The R software and plug-in that could link with the corresponding versions of SPSS and propensity score matching package were installed. A PS matching module was added in the SPSS interface, and its use was demonstrated with test data. Score estimation and nearest neighbor matching was achieved with the PS matching module, and the results of qualitative and quantitative statistical description and evaluation were presented in the form of a graph matching. Propensity score matching can be accomplished conveniently using SPSS software.

Metastatic Spinal Cord Compression from Non-Small-Cell Lung Cancer Treated with Surgery and Adjuvant Therapies: A Retrospective Analysis of Outcomes and Prognostic Factors in 116 Patients.

PubMed

Tang, Yu; Qu, Jintao; Wu, Juan; Li, Song; Zhou, Yue; Xiao, Jianru

2015-09-02

Metastatic spinal cord compression is a disastrous consequence of non-small-cell lung cancer (NSCLC). There have been few studies of the outcomes or prognostic factors in patients with metastatic spinal cord compression from NSCLC treated with surgery and adjuvant therapies. From 2002 to 2013, 116 patients with metastatic spinal cord compression from NSCLC treated with surgery and adjuvant therapies were enrolled in this retrospective analysis. Kaplan-Meier methods and Cox regression analysis were used to estimate overall survival and identify prognostic factors for survival. Multivariate analysis suggested that the Eastern Cooperative Oncology Group performance status (ECOG-PS), preoperative and postoperative Frankel scores, postoperative adjuvant radiation therapy, and target therapy were independent prognostic factors. Ninety patients died at a median of twelve months (range, three to forty-seven months) postoperatively, and twenty-six patients were still alive at the time of final follow-up (at a median of fifteen months [range, five to fifty-four months]). The complete disappearance of deficits in spinal cord function after surgery was the most robust predictor of survival. Adjuvant radiation therapy and target therapy were also associated with a better prognosis. Prognostic Level IV. See Instructions for Authors for a complete description of levels of evidence. Copyright © 2015 by The Journal of Bone and Joint Surgery, Incorporated.

Phase 2 study of bevacizumab plus erlotinib in patients with advanced hepatocellular cancer.

PubMed

Philip, Philip A; Mahoney, Michelle R; Holen, Kyle D; Northfelt, Donald W; Pitot, Henry C; Picus, Joel; Flynn, Patrick J; Erlichman, Charles

2012-05-01

Epidermal growth factor receptor (EGFR) and vascular endothelial growth factor (VEGF) are rational targets for therapy in hepatocellular cancer (HCC). Patients with histologically proven HCC and not amenable to curative or liver directed therapy were included in this 2-stage phase 2 trial. Eligibility included an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1 and Child's Pugh score of A or B, and 1 prior systemic therapy. Patients received erlotinib 150 mg daily and bevacizumab 10 mg/kg on days 1 and 15 every 28 days. Objective tumor response was the primary end point. Twenty-seven patients with advanced HCC (median age, 60 years) were enrolled in this multi-institutional study. The proportion of patients with Child's A classification was 74%. One patient had a confirmed partial response and 11 (48%) achieved stable disease. Median time to disease progression was 3.0 months (95% confidence interval [CI], 1.8-7.1). Median survival time was 9.5 months (95% CI, 7.1-17.1). Grade 3 toxicities included rash, hypertension, fatigue, and diarrhea. In this trial, erlotinib combined with bevacizumab had minimal activity in patients with advanced HCC based on objective response and progression-free survival. The role of targeting EGFR and VEGF in HCC needs further evaluation in molecularly selected patients. Copyright © 2011 American Cancer Society.

Phase 2 Study of Bevacizumab Plus Erlotinib in Patients With Advanced Hepatocellular Cancer

PubMed Central

Philip, Philip A.; Mahoney, Michelle R.; Holen, Kyle D.; Northfelt, Donald W.; Pitot, Henry C.; Picus, Joel; Flynn, Patrick J.; Erlichman, Charles

2013-01-01

BACKGROUND Epidermal growth factor receptor (EGFR) and vascular endothelial growth factor (VEGF) are rational targets for therapy in hepatocellular cancer (HCC). METHODS Patients with histologically proven HCC and not amenable to curative or liver directed therapy were included in this 2-stage phase 2 trial. Eligibility included an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1 and Child’s Pugh score of A or B, and 1 prior systemic therapy. Patients received erlotinib 150 mg daily and bevacizumab 10 mg/kg on days 1 and 15 every 28 days. Objective tumor response was the primary end point. RESULTS Twenty-seven patients with advanced HCC (median age, 60 years) were enrolled in this multi-institutional study. The proportion of patients with Child’s A classification was 74%. One patient had a confirmed partial response and 11 (48%) achieved stable disease. Median time to disease progression was 3.0 months (95% confidence interval [CI], 1.8-7.1). Median survival time was 9.5 months (95% CI, 7.1-17.1). Grade 3 toxicities included rash, hypertension, fatigue, and diarrhea. CONCLUSIONS In this trial, erlotinib combined with bevacizumab had minimal activity in patients with advanced HCC based on objective response and progression-free survival. The role of targeting EGFR and VEGF in HCC needs further evaluation in molecularly selected patients. PMID:21953248

Clinical characteristics and quality-of-life in patients surviving a decade of prostate cancer with bone metastases.

PubMed

Klaff, Rami; Berglund, Anders; Varenhorst, Eberhard; Hedlund, Per Olov; Jǿnler, Morten; Sandblom, Gabriel

2016-06-01

To describe characteristics and quality-of-life (QoL), and to define factors associated with long-term survival in a subgroup of patients with prostate cancer with M1b disease. The study was based on 915 patients from a prospective randomised multicentre trial (No. 5) by the Scandinavian Prostate Cancer Group, comparing parenteral oestrogen with total androgen blockade. Long-term survival was defined as patients having an overall survival of ≥10 years, and logistic regression models were constructed to identity clinical predictors of survival. QoL during follow-up was assessed using the European Organisation for Research and Treatment of Cancer Quality-of-Life Questionnaire - C30 version 1 (EORTC-C30) ratings. In all, 40 (4.4%) of the 915 men survived for >10 years. Factors significantly associated with increased likelihood of surviving for >10 years in the univariate analyses were: absence of cancer-related pain; Eastern Cooperative Oncology Group (ECOG) performance status of <2; negligible analgesic consumption; T-category of 1-2; prostate-specific antigen (PSA) level of <231 μg/L; and a Soloway score of 1. In the multivariate analyses, ECOG performance status of <2, PSA level of <231 μg/L, and Soloway score of 1, were all independent predictors of long-term survival. All subscales of the EORTC-C30 were higher in this group than for patients with short survival, but slowly declined over the decade. A subgroup of patients with prostate cancer with M1b disease and certain characteristics showed a positive long-term response to androgen-deprivation therapy with an acceptable QoL over a decade or more. Independent predictors of long-term survival were identified as ECOG performance status of <2, limited extent of bone metastases (Soloway score of 1), and a PSA level of <231 μg/L at the time of enrolment. © 2015 The Authors BJU International © 2015 BJU International Published by John Wiley & Sons Ltd.

A method to score radiographic change in psoriatic arthritis.

PubMed

Wassenberg, S; Fischer-Kahle, V; Herborn, G; Rau, R

2001-06-01

Radiographic features of psoriatic arthritis (PsA) are very characteristic and differ from those observed in rheumatoid arthritis, especially in two aspects: 1) the distribution of affected joints (i.e. DIP joints), 2) the presence of destructive changes and bone proliferation at the same time. A scoring method for PsA, therefore, has to account for these characteristics of PsA. To develop, describe and validate a method for scoring radiographic changes in patients with PsA. Forty joints of the hands and feet are scored for destruction and proliferation. In the destruction score (DS) grading on a 0-5 scale is based on the amount of joint surface destruction: 0 = normal, 1 = one or more erosions with an interruption of the cortical plate of > 1 mm with destruction of the total joint surface up to 10%, 2 = 11-25%, 3 = 26-50%, 4 = 51-75%, 5 = > 75% joint surface destruction. The proliferation score (PS) sums up any kind of bony proliferation typical for PsA; graded 0-4: 0 = normal, 1 = bony proliferation of 1-2 mm or bone growth < 25% of the original size (diameter), 2 = bony proliferation 2-3 mm or bone growth 25-50%, 3 = bony proliferation > 3 mm or bone growth > 50%, 4 = bony ankylosis. The DS (0-200) and the PS (0-160) can be summed up to the total score (0-360). VALIDATION OF THE METHOD: To validate the method x-rays of 20 patients with active PsA taken 3 years apart were read twice in pairs, knowing the chronological order but not knowing demographic, clinical or laboratory data of the patients. The data were analyzed with a hierarchical analysis of variance model. There was good agreement between the first and the second reading of the same rater and between the two raters regarding the destruction score. The agreement regarding the proliferation score was lower but still acceptable. The reliability of the method to describe change over time--relation of progression (intra-patient variance) to the measurement error (inter-rater variance)--was 3.9 for the DS, 2.8 for the PS and 4.1 for the total score. The minimal detectable change when the readings of two raters were compared (inter-rater MDC) was 5.8, 5.0 and 4.6%, respectively of the maximum possible score for the destruction, the proliferation and the total score. These data compare very well with the results of standard scoring methods in rheumatoid arthritis. We propose a method for scoring radiographic change in psoriatic arthritis which reliably quantifies the progression of the disease seen on radiographs.

Increased body mass index is associated with improved overall survival in extranodal natural killer/T-cell lymphoma, nasal type.

PubMed

Li, Ya-Jun; Yi, Ping-Yong; Li, Ji-Wei; Liu, Xian-Ling; Liu, Xi-Yu; Zhou, Fang; OuYang, Zhou; Sun, Zhong-Yi; Huang, Li-Jun; He, Jun-Qiao; Yao, Yuan; Fan, Zhou; Tang, Tian; Jiang, Wen-Qi

2017-01-17

The role of body mass index (BMI) in lymphoma survival outcomes is controversial. The prognostic significance of BMI in extranodal natural killer (NK)/T-cell lymphoma (ENKTL) is unclear. We evaluated the prognostic role of BMI in patients with ENKTL. We retrospectively analyzed 742 patients with newly diagnosed ENKTL. The prognostic value of BMI was compared between patients with low BMIs (< 20.0 kg/m2) and patients with high BMIs (≥ 20.0 kg/m2). The prognostic value of the International Prognostic Index (IPI) and the Korean Prognostic Index (KPI) was also evaluated and compared with that of the BMI classification. Patients with low BMIs tended to exhibit higher Eastern Cooperative Oncology Group performance status (ECOG PS) scores (≥ 2) (P = 0.001), more frequent B symptoms (P < 0.001), lower albumin levels (P < 0.001), higher KPI scores (P = 0.03), and lower rates of complete remission (P < 0.001) than patients with high BMIs, as well as inferior progression-free survival (PFS, P = 0.003), and inferior overall survival (OS, P = 0.001). Multivariate analysis demonstrated that age > 60 years, mass > 5 cm, stage III/IV, elevated LDH levels, albumin levels < 35 g/L and low BMIs were independent adverse predictors of OS. The BMI classification was found to be superior to the IPI with respect to predicting patient outcomes among low-risk patients and the KPI with respect to distinguishing between intermediate-low- and high-intermediate-risk patients. Higher BMI at the time of diagnosis is associated with improved overall survival in ENKTL. Using the BMI classification may improve the IPI and KPI prognostic models.

Increased body mass index is associated with improved overall survival in extranodal natural killer/T-cell lymphoma, nasal type

PubMed Central

Li, Ya-Jun; Yi, Ping-Yong; Li, Ji-Wei; Liu, Xian-Ling; Liu, Xi-Yu; Zhou, Fang; OuYang, Zhou; Sun, Zhong-Yi; Huang, Li-Jun; He, Jun-Qiao; Yao, Yuan; Fan, Zhou; Tang, Tian; Jiang, Wen-Qi

2017-01-01

Objectives: The role of body mass index (BMI) in lymphoma survival outcomes is controversial. The prognostic significance of BMI in extranodal natural killer (NK)/T-cell lymphoma (ENKTL) is unclear. We evaluated the prognostic role of BMI in patients with ENKTL. Methods: We retrospectively analyzed 742 patients with newly diagnosed ENKTL. The prognostic value of BMI was compared between patients with low BMIs (< 20.0 kg/m2) and patients with high BMIs (≥ 20.0 kg/m2). The prognostic value of the International Prognostic Index (IPI) and the Korean Prognostic Index (KPI) was also evaluated and compared with that of the BMI classification. Results: Patients with low BMIs tended to exhibit higher Eastern Cooperative Oncology Group performance status (ECOG PS) scores (≥ 2) (P = 0.001), more frequent B symptoms (P < 0.001), lower albumin levels (P < 0.001), higher KPI scores (P = 0.03), and lower rates of complete remission (P < 0.001) than patients with high BMIs, as well as inferior progression-free survival (PFS, P = 0.003), and inferior overall survival (OS, P = 0.001). Multivariate analysis demonstrated that age > 60 years, mass > 5 cm, stage III/IV, elevated LDH levels, albumin levels < 35 g/L and low BMIs were independent adverse predictors of OS. The BMI classification was found to be superior to the IPI with respect to predicting patient outcomes among low-risk patients and the KPI with respect to distinguishing between intermediate-low- and high-intermediate-risk patients. Conclusions: Higher BMI at the time of diagnosis is associated with improved overall survival in ENKTL. Using the BMI classification may improve the IPI and KPI prognostic models. PMID:28002803

RAId_aPS: MS/MS Analysis with Multiple Scoring Functions and Spectrum-Specific Statistics

PubMed Central

Alves, Gelio; Ogurtsov, Aleksey Y.; Yu, Yi-Kuo

2010-01-01

Statistically meaningful comparison/combination of peptide identification results from various search methods is impeded by the lack of a universal statistical standard. Providing an -value calibration protocol, we demonstrated earlier the feasibility of translating either the score or heuristic -value reported by any method into the textbook-defined -value, which may serve as the universal statistical standard. This protocol, although robust, may lose spectrum-specific statistics and might require a new calibration when changes in experimental setup occur. To mitigate these issues, we developed a new MS/MS search tool, RAId_aPS, that is able to provide spectrum-specific -values for additive scoring functions. Given a selection of scoring functions out of RAId score, K-score, Hyperscore and XCorr, RAId_aPS generates the corresponding score histograms of all possible peptides using dynamic programming. Using these score histograms to assign -values enables a calibration-free protocol for accurate significance assignment for each scoring function. RAId_aPS features four different modes: (i) compute the total number of possible peptides for a given molecular mass range, (ii) generate the score histogram given a MS/MS spectrum and a scoring function, (iii) reassign -values for a list of candidate peptides given a MS/MS spectrum and the scoring functions chosen, and (iv) perform database searches using selected scoring functions. In modes (iii) and (iv), RAId_aPS is also capable of combining results from different scoring functions using spectrum-specific statistics. The web link is http://www.ncbi.nlm.nih.gov/CBBresearch/Yu/raid_aps/index.html. Relevant binaries for Linux, Windows, and Mac OS X are available from the same page. PMID:21103371

A Phase-Locked Loop Epilepsy Network Emulator.

PubMed

Watson, P D; Horecka, K M; Cohen, N J; Ratnam, R

2016-10-15

Most seizure forecasting employs statistical learning techniques that lack a representation of the network interactions that give rise to seizures. We present an epilepsy network emulator (ENE) that uses a network of interconnected phase-locked loops (PLLs) to model synchronous, circuit-level oscillations between electrocorticography (ECoG) electrodes. Using ECoG data from a canine-epilepsy model (Davis et al. 2011) and a physiological entropy measure (approximate entropy or ApEn, Pincus 1995), we demonstrate the entropy of the emulator phases increases dramatically during ictal periods across all ECoG recording sites and across all animals in the sample. Further, this increase precedes the observable voltage spikes that characterize seizure activity in the ECoG data. These results suggest that the ENE is sensitive to phase-domain information in the neural circuits measured by ECoG and that an increase in the entropy of this measure coincides with increasing likelihood of seizure activity. Understanding this unpredictable phase-domain electrical activity present in ECoG recordings may provide a target for seizure detection and feedback control.

Propensity Score-Based Methods versus MTE-Based Methods in Causal Inference: Identification, Estimation, and Application

ERIC Educational Resources Information Center

Zhou, Xiang; Xie, Yu

2016-01-01

Since the seminal introduction of the propensity score (PS) by Rosenbaum and Rubin, PS-based methods have been widely used for drawing causal inferences in the behavioral and social sciences. However, the PS approach depends on the ignorability assumption: there are no unobserved confounders once observed covariates are taken into account. For…

The significance of oral streptococci in patients with pneumonia with risk factors for aspiration: the bacterial floral analysis of 16S ribosomal RNA gene using bronchoalveolar lavage fluid.

PubMed

Akata, Kentaro; Yatera, Kazuhiro; Yamasaki, Kei; Kawanami, Toshinori; Naito, Keisuke; Noguchi, Shingo; Fukuda, Kazumasa; Ishimoto, Hiroshi; Taniguchi, Hatsumi; Mukae, Hiroshi

2016-05-11

Aspiration pneumonia has been a growing interest in an aging population. Anaerobes are important pathogens, however, the etiology of aspiration pneumonia is not fully understood. In addition, the relationship between the patient clinical characteristics and the causative pathogens in pneumonia patients with aspiration risk factors are unclear. To evaluate the relationship between the patient clinical characteristics with risk factors for aspiration and bacterial flora in bronchoalveolar lavage fluid (BALF) in pneumonia patients, the bacterial floral analysis of 16S ribosomal RNA gene was applied in addition to cultivation methods in BALF samples. From April 2010 to February 2014, BALF samples were obtained from the affected lesions of pneumonia via bronchoscopy, and were evaluated by the bacterial floral analysis of 16S rRNA gene in addition to cultivation methods in patients with community-acquired pneumonia (CAP) and healthcare-associated pneumonia (HCAP). Factors associated with aspiration risks in these patients were analyzed. A total of 177 (CAP 83, HCAP 94) patients were enrolled. According to the results of the bacterial floral analysis, detection rate of oral streptococci as the most detected bacterial phylotypes in BALF was significantly higher in patients with aspiration risks (31.0 %) than in patients without aspiration risks (14.7 %) (P = 0.009). In addition, the percentages of oral streptococci in each BALF sample were significantly higher in patients with aspiration risks (26.6 ± 32.0 %) than in patients without aspiration risks (13.8 ± 25.3 %) (P = 0.002). A multiple linear regression analysis showed that an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of ≥3, the presence of comorbidities, and a history of pneumonia within a previous year were significantly associated with a detection of oral streptococci in BALF. The bacterial floral analysis of 16S rRNA gene revealed that oral streptococci were mostly detected as the most detected bacterial phylotypes in BALF samples in CAP and HCAP patients with aspiration risks, especially in those with a poor ECOG-PS or a history of pneumonia.

Atezolizumab in Platinum-treated Locally Advanced or Metastatic Urothelial Carcinoma: Clinical Experience from an Expanded Access Study in the United States.

PubMed

Pal, Sumanta Kumar; Hoffman-Censits, Jean; Zheng, Hanzhe; Kaiser, Constanze; Tayama, Darren; Bellmunt, Joaquim

2018-05-01

Atezolizumab (anti-programmed death-ligand 1) was approved in the USA, Europe, and elsewhere for treatment-naive and platinum-treated locally advanced/metastatic urothelial carcinoma (mUC). To report efficacy and safety from an atezolizumab expanded access study. This single-arm, open-label study enrolled 218 patients at 36 US sites. Key eligibility criteria included progression during/following ≥1 platinum-based chemotherapy for mUC or in perioperative setting (progression within 12 mo) and Eastern Cooperative Oncology Group performance status (ECOG PS) 0-2. Patients received atezolizumab1200mg intravenously every 3 wk until loss of clinical benefit, unacceptable toxicity, consent withdrawal, decision to discontinue, death, atezolizumab commercial availability, or study closure. Key end points reported herein included Response Evaluation Criteria in Solid Tumors v1.1 objective response rate and duration, disease control rate (DCR; response or stable disease), and safety. All patients received prior systemic therapy (68% mUC; 27% adjuvant; and 26% neoadjuvant). At baseline, 57% of 214 treated patients had ECOG PS ≥1, 19% had hemoglobin <10g/dl, and 25% had liver metastases. Median treatment duration was 9 wk (interquartile range [IQR], 6-12 wk). Median follow-up duration was 2.3 mo (IQR, 1.6-3.4 mo) overall and 2.7 mo (IQR, 2.0-3.5 mo) in patients not known to have died. Seventeen of 114 evaluable patients (15%) had objective responses (16 ongoing at study termination). DCR was 49%. Treatment-related adverse events (mostly fatigue) occurred in 98 of 214 treated patients. The benefit/risk profile of atezolizumab was consistent with that observed in previous studies, despite pretreatment and poor prognostic factors. These results suggest a potential role for atezolizumab in a broader patient range than typically eligible for phase 1-3 studies. In this expanded access study, atezolizumab was active and tolerable in a range of patients with platinum-treated metastatic urothelial carcinoma. Copyright © 2018 European Association of Urology. Published by Elsevier B.V. All rights reserved.

Relationship between patient-reported outcomes and clinical outcomes in metastatic castration-resistant prostate cancer: post hoc analysis of COU-AA-301 and COU-AA-302.

PubMed

Cella, D; Traina, S; Li, T; Johnson, K; Ho, K F; Molina, A; Shore, N D

2018-02-01

Patient-reported outcomes (PROs) are used to assess benefit-risk in drug development. The relationship between PROs and clinical outcomes is not well understood. We aim to elucidate the relationships between changes in PRO measures and clinical outcomes in metastatic castration-resistant prostate cancer (mCRPC). We investigated relationships between changes in self-reported fatigue, pain, functional well-being (FWB), physical well-being (PWB) and prostate cancer-specific symptoms with overall survival (OS) and radiographic progression-free survival (rPFS) after 6 and 12 months of treatment in COU-AA-301 (N = 1195) or COU-AA-302 (N = 1088). Eligible COU-AA-301 patients had progressed after docetaxel and had Eastern Cooperative Oncology Group performance status (ECOG PS) ≤ 2. Eligible COU-AA-302 patients had no prior chemotherapy and ECOG PS 0 or 1. Patients were treated with abiraterone acetate (1000 mg/day) plus prednisone (10 mg/day) or prednisone alone daily. Association between self-reported fatigue, pain and functional status, and OS and/or rPFS, using pooled data regardless of treatment, was assessed. Cox proportional hazard regression modeled time to death or radiographic progression. In COU-AA-301 patients, PRO improvements were associated with longer OS and longer time to radiographic progression versus worsening or stable PROs (P < 0.0001). In multivariate models, all except pain intensity remained associated with OS. Pain intensity, PWB and FWB improvements remained associated with rPFS. In COU-AA-302 patients, worsening PROs were associated with higher likelihood of radiographic progression (P ≤ 0.025) compared with improved or stable PROs. In multivariate models, worsening PWB remained associated with worse rPFS. The 12-month analysis confirmed the 6-month results. PROs are significantly associated with clinically relevant time-to-event efficacy outcomes in clinical trials and may complement and help predict traditional clinical practice methods for monitoring patients for disease progression. © The Author 2017. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For permissions, please email: journals.permissions@oup.com.

Removing interictal fast ripples on electrocorticography linked with seizure freedom in children.

PubMed

Wu, J Y; Sankar, R; Lerner, J T; Matsumoto, J H; Vinters, H V; Mathern, G W

2010-11-09

Fast ripples (FR, 250-500 Hz) detected with chronic intracranial electrodes are proposed biomarkers of epileptogenesis. This study determined whether resection of FR-containing neocortex recorded during intraoperative electrocorticography (ECoG) was associated with postoperative seizure freedom in pediatric patients with mostly extratemporal lesions. FRs were retrospectively reviewed in 30 consecutive pediatric cases. ECoGs were recorded at 2,000 Hz sampling rate and visually inspected for FR, with reviewer blinded to the resection and outcome. Average age at surgery was 9.1 ± 6.7 years, ECoG duration was 11.8 ± 8.1 minutes, and postoperative follow-up was 27 ± 4 months. FRs were undetected in 6 ECoGs with remote or extensive lesions. FR episodes (n = 273) were identified in ECoGs from 24 patients, and in 64% FRs were independent of spikes, sharp waves, voltage attenuation, and paroxysmal fast activity. Of these 24 children, FR-containing cortex was removed in 19 and all became seizure-free, including 1 child after a second surgery. The remaining 5 children had incomplete FR resection and all continued with seizures postoperatively. In 2 ECoGs, the location of electrographic seizures matched FR location. FR-containing cortex was found outside of MRI and FDG-PET abnormalities in 6 children. FRs were detected during intraoperative ECoG in 80% of pediatric epilepsy cases, and complete resection of FR cortex correlated with postoperative seizure freedom. These findings support the view that interictal FRs are excellent surrogate markers of epileptogenesis, can be recorded during brief ECoG, and could be used to guide future surgical resections in children.

A new method for quantifying the performance of EEG blind source separation algorithms by referencing a simultaneously recorded ECoG signal.

PubMed

Oosugi, Naoya; Kitajo, Keiichi; Hasegawa, Naomi; Nagasaka, Yasuo; Okanoya, Kazuo; Fujii, Naotaka

2017-09-01

Blind source separation (BSS) algorithms extract neural signals from electroencephalography (EEG) data. However, it is difficult to quantify source separation performance because there is no criterion to dissociate neural signals and noise in EEG signals. This study develops a method for evaluating BSS performance. The idea is neural signals in EEG can be estimated by comparison with simultaneously measured electrocorticography (ECoG). Because the ECoG electrodes cover the majority of the lateral cortical surface and should capture most of the original neural sources in the EEG signals. We measured real EEG and ECoG data and developed an algorithm for evaluating BSS performance. First, EEG signals are separated into EEG components using the BSS algorithm. Second, the EEG components are ranked using the correlation coefficients of the ECoG regression and the components are grouped into subsets based on their ranks. Third, canonical correlation analysis estimates how much information is shared between the subsets of the EEG components and the ECoG signals. We used our algorithm to compare the performance of BSS algorithms (PCA, AMUSE, SOBI, JADE, fastICA) via the EEG and ECoG data of anesthetized nonhuman primates. The results (Best case >JADE = fastICA >AMUSE = SOBI ≥ PCA >random separation) were common to the two subjects. To encourage the further development of better BSS algorithms, our EEG and ECoG data are available on our Web site (http://neurotycho.org/) as a common testing platform. Copyright © 2017 The Author(s). Published by Elsevier Ltd.. All rights reserved.

Electrocorticographic language mapping in children by high-gamma synchronization during spontaneous conversation: comparison with conventional electrical cortical stimulation.

PubMed

Arya, Ravindra; Wilson, J Adam; Vannest, Jennifer; Byars, Anna W; Greiner, Hansel M; Buroker, Jason; Fujiwara, Hisako; Mangano, Francesco T; Holland, Katherine D; Horn, Paul S; Crone, Nathan E; Rose, Douglas F

2015-02-01

This study describes development of a novel language mapping approach using high-γ modulation in electrocorticograph (ECoG) during spontaneous conversation, and its comparison with electrical cortical stimulation (ECS) in childhood-onset drug-resistant epilepsy. Patients undergoing invasive pre-surgical monitoring and able to converse with the investigator were eligible. ECoG signals and synchronized audio were acquired during quiet baseline and during natural conversation between investigator and the patient. Using Signal Modeling for Real-time Identification and Event Detection (SIGFRIED) procedure, a statistical model for baseline high-γ (70-116 Hz) power, and a single score for each channel representing the probability that the power features in the experimental signal window belonged to the baseline model, were calculated. Electrodes with significant high-γ responses (HGS) were plotted on the 3D cortical model. Sensitivity, specificity, positive and negative predictive values (PPV, NPV), and classification accuracy were calculated compared to ECS. Seven patients were included (4 males, mean age 10.28 ± 4.07 years). Significant high-γ responses were observed in classic language areas in the left hemisphere plus in some homologous right hemispheric areas. Compared with clinical standard ECS mapping, the sensitivity and specificity of HGS mapping was 88.89% and 63.64%, respectively, and PPV and NPV were 35.29% and 96.25%, with an overall accuracy of 68.24%. HGS mapping was able to correctly determine all ECS+ sites in 6 of 7 patients and all false-sites (ECS+, HGS- for visual naming, n = 3) were attributable to only 1 patient. This study supports the feasibility of language mapping with ECoG HGS during spontaneous conversation, and its accuracy compared to traditional ECS. Given long-standing concerns about ecological validity of ECS mapping of cued language tasks, and difficulties encountered with its use in children, ECoG mapping of spontaneous language may provide a valid alternative for clinical use. Copyright © 2014 Elsevier B.V. All rights reserved.

A Multigene Expression Assay to Predict Local Recurrence Risk for Ductal Carcinoma In Situ of the Breast

PubMed Central

2013-01-01

Background For women with ductal carcinoma in situ (DCIS) of the breast, the risk of developing an ipsilateral breast event (IBE; defined as local recurrence of DCIS or invasive carcinoma) after surgical excision without radiation is not well defined by clinical and pathologic characteristics. Methods The Oncotype DX breast cancer assay was performed for patients with DCIS treated with surgical excision without radiation in the Eastern Cooperative Oncology Group (ECOG) E5194 study. The association of the prospectively defined DCIS Score (calculated from seven cancer-related genes and five reference genes) with the risk of developing an IBE was analyzed using Cox regression. All statistical tests were two-sided. Results There were 327 patients with adequate tissue for analysis. The continuous DCIS Score was statistically significantly associated with the risk of developing an IBE (hazard ratio [HR] = 2.31, 95% confidence interval [CI] = 1.15 to 4.49; P = .02) when adjusted for tamoxifen use (prespecified primary analysis) and with invasive IBE (unadjusted HR = 3.68, 95% CI = 1.34 to 9.62; P = .01). For the prespecified DCIS risk groups of low, intermediate, and high, the 10-year risks of developing an IBE were 10.6%, 26.7%, and 25.9%, respectively, and for an invasive IBE, 3.7%, 12.3%, and 19.2%, respectively (both log rank P ≤ .006). In multivariable analyses, factors associated with IBE risk were DCIS Score, tumor size, and menopausal status (all P ≤ .02). Conclusions The DCIS Score quantifies IBE risk and invasive IBE risk, complements traditional clinical and pathologic factors, and provides a new clinical tool to improve selecting individualized treatment for women with DCIS who meet the ECOG E5194 criteria. PMID:23641039

A multigene expression assay to predict local recurrence risk for ductal carcinoma in situ of the breast.

PubMed

Solin, Lawrence J; Gray, Robert; Baehner, Frederick L; Butler, Steven M; Hughes, Lorie L; Yoshizawa, Carl; Cherbavaz, Diana B; Shak, Steven; Page, David L; Sledge, George W; Davidson, Nancy E; Ingle, James N; Perez, Edith A; Wood, William C; Sparano, Joseph A; Badve, Sunil

2013-05-15

For women with ductal carcinoma in situ (DCIS) of the breast, the risk of developing an ipsilateral breast event (IBE; defined as local recurrence of DCIS or invasive carcinoma) after surgical excision without radiation is not well defined by clinical and pathologic characteristics. The Oncotype DX breast cancer assay was performed for patients with DCIS treated with surgical excision without radiation in the Eastern Cooperative Oncology Group (ECOG) E5194 study. The association of the prospectively defined DCIS Score (calculated from seven cancer-related genes and five reference genes) with the risk of developing an IBE was analyzed using Cox regression. All statistical tests were two-sided. There were 327 patients with adequate tissue for analysis. The continuous DCIS Score was statistically significantly associated with the risk of developing an IBE (hazard ratio [HR] = 2.31, 95% confidence interval [CI] = 1.15 to 4.49; P = .02) when adjusted for tamoxifen use (prespecified primary analysis) and with invasive IBE (unadjusted HR = 3.68, 95% CI = 1.34 to 9.62; P = .01). For the prespecified DCIS risk groups of low, intermediate, and high, the 10-year risks of developing an IBE were 10.6%, 26.7%, and 25.9%, respectively, and for an invasive IBE, 3.7%, 12.3%, and 19.2%, respectively (both log rank P ≤ .006). In multivariable analyses, factors associated with IBE risk were DCIS Score, tumor size, and menopausal status (all P ≤ .02). The DCIS Score quantifies IBE risk and invasive IBE risk, complements traditional clinical and pathologic factors, and provides a new clinical tool to improve selecting individualized treatment for women with DCIS who meet the ECOG E5194 criteria.

A Phase-Locked Loop Epilepsy Network Emulator

PubMed Central

Watson, P.D.; Horecka, K. M.; Cohen, N.J.; Ratnam, R.

2015-01-01

Most seizure forecasting employs statistical learning techniques that lack a representation of the network interactions that give rise to seizures. We present an epilepsy network emulator (ENE) that uses a network of interconnected phase-locked loops (PLLs) to model synchronous, circuit-level oscillations between electrocorticography (ECoG) electrodes. Using ECoG data from a canine-epilepsy model (Davis et al. 2011) and a physiological entropy measure (approximate entropy or ApEn, Pincus 1995), we demonstrate the entropy of the emulator phases increases dramatically during ictal periods across all ECoG recording sites and across all animals in the sample. Further, this increase precedes the observable voltage spikes that characterize seizure activity in the ECoG data. These results suggest that the ENE is sensitive to phase-domain information in the neural circuits measured by ECoG and that an increase in the entropy of this measure coincides with increasing likelihood of seizure activity. Understanding this unpredictable phase-domain electrical activity present in ECoG recordings may provide a target for seizure detection and feedback control. PMID:26664133

Comparison of the predictive performance of the BIG, TRISS, and PS09 score in an adult trauma population derived from multiple international trauma registries

PubMed Central

2013-01-01

Background The BIG score (Admission base deficit (B), International normalized ratio (I), and Glasgow Coma Scale (G)) has been shown to predict mortality on admission in pediatric trauma patients. The objective of this study was to assess its performance in predicting mortality in an adult trauma population, and to compare it with the existing Trauma and Injury Severity Score (TRISS) and probability of survival (PS09) score. Materials and methods A retrospective analysis using data collected between 2005 and 2010 from seven trauma centers and registries in Europe and the United States of America was performed. We compared the BIG score with TRISS and PS09 scores in a population of blunt and penetrating trauma patients. We then assessed the discrimination ability of all scores via receiver operating characteristic (ROC) curves and compared the expected mortality rate (precision) of all scores with the observed mortality rate. Results In total, 12,206 datasets were retrieved to validate the BIG score. The mean ISS was 15 ± 11, and the mean 30-day mortality rate was 4.8%. With an AUROC of 0.892 (95% confidence interval (CI): 0.879 to 0.906), the BIG score performed well in an adult population. TRISS had an area under ROC (AUROC) of 0.922 (0.913 to 0.932) and the PS09 score of 0.825 (0.915 to 0.934). On a penetrating-trauma population, the BIG score had an AUROC result of 0.920 (0.898 to 0.942) compared with the PS09 score (AUROC of 0.921; 0.902 to 0.939) and TRISS (0.929; 0.912 to 0.947). Conclusions The BIG score is a good predictor of mortality in the adult trauma population. It performed well compared with TRISS and the PS09 score, although it has significantly less discriminative ability. In a penetrating-trauma population, the BIG score performed better than in a population with blunt trauma. The BIG score has the advantage of being available shortly after admission and may be used to predict clinical prognosis or as a research tool to risk stratify trauma patients into clinical trials. PMID:23844754

Portable wireless electrocorticography system with a flexible microelectrodes array for epilepsy treatment.

PubMed

Xie, Kejun; Zhang, Shaomin; Dong, Shurong; Li, Shijian; Yu, Chaonan; Xu, Kedi; Chen, Wanke; Guo, Wei; Luo, Jikui; Wu, Zhaohui

2017-08-10

In this paper, we present a portable wireless electrocorticography (ECoG) system. It uses a high resolution 32-channel flexible ECoG electrodes array to collect electrical signals of brain activities and to stimulate the lesions. Electronic circuits are designed for signal acquisition, processing and transmission using Bluetooth Low Energy 4 (LTE4) for wireless communication with cell phone. In-vivo experiments on a rat show that the flexible ECoG system can accurately record electrical signals of brain activities and transmit them to cell phone with a maximal sampling rate of 30 ksampling/s per channel. It demonstrates that the epilepsy lesions can be detected, located and treated through the ECoG system. The wireless ECoG system has low energy consumption and high brain spatial resolution, thus has great prospects for future application.

Validation of the OMERACT Psoriatic Arthritis Magnetic Resonance Imaging Score (PsAMRIS) for the Hand and Foot in a Randomized Placebo-controlled Trial.

PubMed

Glinatsi, Daniel; Bird, Paul; Gandjbakhch, Frederique; Mease, Philip J; Bøyesen, Pernille; Peterfy, Charles G; Conaghan, Philip G; Østergaard, Mikkel

2015-12-01

To assess changes following treatment and the reliability and responsiveness to change of the Outcome Measures in Rheumatology (OMERACT) Psoriatic Arthritis Magnetic Resonance Imaging Score (PsAMRIS) in a randomized controlled trial. Forty patients with PsA randomized to either placebo or abatacept (ABA) had MRI of either 1 hand (n = 20) or 1 foot (n = 20) at baseline and after 6 months. Images were scored blindly twice by 3 independent readers according to the PsAMRIS (for synovitis, tenosynovitis, periarticular inflammation, bone edema, bone erosion, and bone proliferation). Inflammatory features improved numerically but statistically nonsignificantly in the ABA group but not the placebo group. Baseline intrareader intraclass correlation coefficients (ICC) were good (≥ 0.50) to very good (≥ 0.80) for all features in both hand and foot. Baseline interreader ICC were good (ICC 0.72-0.96) for all features, except periarticular inflammation and bone proliferation in the hand and tenosynovitis in the foot (ICC 0.25-0.44). Intrareader and interreader ICC for change scores varied. Guyatt's responsiveness index (GRI) was high for inflammatory features in the hand and metatarsophalangeal joints (GRI -0.67 to -3.13; bone edema not calculable). Minimal change and low prevalence resulted in low ICC and GRI for bone damage. PsAMRIS showed overall good intrareader agreement in the hand and foot, and inflammatory feature scores were responsive to change, suggesting that PsAMRIS may be a valid tool for MRI assessment of hands and feet in PsA clinical trials.

Evaluating large-scale propensity score performance through real-world and synthetic data experiments.

PubMed

Tian, Yuxi; Schuemie, Martijn J; Suchard, Marc A

2018-06-22

Propensity score adjustment is a popular approach for confounding control in observational studies. Reliable frameworks are needed to determine relative propensity score performance in large-scale studies, and to establish optimal propensity score model selection methods. We detail a propensity score evaluation framework that includes synthetic and real-world data experiments. Our synthetic experimental design extends the 'plasmode' framework and simulates survival data under known effect sizes, and our real-world experiments use a set of negative control outcomes with presumed null effect sizes. In reproductions of two published cohort studies, we compare two propensity score estimation methods that contrast in their model selection approach: L1-regularized regression that conducts a penalized likelihood regression, and the 'high-dimensional propensity score' (hdPS) that employs a univariate covariate screen. We evaluate methods on a range of outcome-dependent and outcome-independent metrics. L1-regularization propensity score methods achieve superior model fit, covariate balance and negative control bias reduction compared with the hdPS. Simulation results are mixed and fluctuate with simulation parameters, revealing a limitation of simulation under the proportional hazards framework. Including regularization with the hdPS reduces commonly reported non-convergence issues but has little effect on propensity score performance. L1-regularization incorporates all covariates simultaneously into the propensity score model and offers propensity score performance superior to the hdPS marginal screen.

Medical risk assessment in dentistry: use of the American Society of Anesthesiologists Physical Status Classification.

PubMed

Clough, S; Shehabi, Z; Morgan, C

2016-02-12

Medical risk assessment is essential to safe patient management and the delivery of appropriate dental care. The American Society of Anesthesiologists Physical Status (ASA PS) Classification is widely used within medicine and dentistry, but has received significant criticism. This is the first UK survey to assess the consistency of medical risk assessment in dentistry. (i) To determine the use and consistency of the ASA PS among dentists and anaesthetists. (ii) To consider the appropriateness of the ASA PS in relation to dental treatment planning and delivery of care. A cross-sectional online questionnaire was distributed to anaesthetists and dental practitioners in general practice, community and hospital dental services. Questions focused on professional backgrounds, use of the ASA PS, alternative approaches to risk assessment in everyday practice and scoring of eight hypothetical patients using ASA PS. There were 101 responses, 82 were complete. Anaesthetists recorded ASA PS score more frequently than dental practitioners and found it more useful. Inconsistencies were evident in the assignment of ASA PS scores both between and within professional groups. Many dental practitioners did not use or find ASA PS helpful, with significant inconsistencies in its use. An awareness of alternative assessment scales may be useful across settings. Accepting its limitations, it would be helpful for all dentists to be educated in ASA PS and its use in medical risk assessment, particularly in relation to conscious sedation.

ECoG Gamma Activity during a Language Task: Differentiating Expressive and Receptive Speech Areas

ERIC Educational Resources Information Center

Towle, Vernon L.; Yoon, Hyun-Ah; Castelle, Michael; Edgar, J. Christopher; Biassou, Nadia M.; Frim, David M.; Spire, Jean-Paul; Kohrman, Michael H.

2008-01-01

Electrocorticographic (ECoG) spectral patterns obtained during language tasks from 12 epilepsy patients (age: 12-44 years) were analyzed in order to identify and characterize cortical language areas. ECoG from 63 subdural electrodes (500 Hz/channel) chronically implanted over frontal, parietal and temporal lobes were examined. Two language tasks…

The Neurologic Assessment in Neuro-Oncology (NANO) Scale as an Assessment Tool for Survival in Patients With Primary Glioblastoma.

PubMed

Ung, Timothy H; Ney, Douglas E; Damek, Denise; Rusthoven, Chad G; Youssef, A Samy; Lillehei, Kevin O; Ormond, D Ryan

2018-03-30

The Neurologic Assessment in Neuro-Oncology (NANO) scale is a standardized objective metric designed to measure neurological function in neuro-oncology. Current neuroradiological evaluation guidelines fail to use specific clinical criteria for progression. To determine if the NANO scale was a reliable assessment tool in glioblastoma (GBM) patients and whether it correlated to survival. Our group performed a retrospective review of all patients with newly diagnosed GBM from January 1, 2010, through December 31, 2012, at our institution. We applied the NANO scale, Karnofsky performance score (KPS), Eastern Cooperative Oncology Group (ECOG) scale, Macdonald criteria, and the Response Assessment in Neuro-Oncology (RANO) criteria to patients at the time of diagnosis as well as at 3, 6, and 12 mo. Initial NANO score was correlated with overall survival at time of presentation. NANO progression was correlated with decreased survival in patients at 6 and 12 mo. A decrease in KPS was associated with survival at 3 and 6 mo, an increase in ECOG score was associated only at 3 mo, and radiological evaluation (RANO and Macdonald) was correlated at 3 and 6 mo. Only the NANO scale was associated with patient survival at 1 yr. NANO progression was the only metric that was linked to decreased overall survival when compared to RANO and Macdonald at 6 and 12 mo. The NANO scale is specific to neuro-oncology and can be used to assess patients with glioma. This retrospective analysis demonstrates the usefulness of the NANO scale in glioblastoma.

Interictal scalp electroencephalography and intraoperative electrocorticography in magnetic resonance imaging-negative temporal lobe epilepsy surgery.

PubMed

Burkholder, David B; Sulc, Vlastimil; Hoffman, E Matthew; Cascino, Gregory D; Britton, Jeffrey W; So, Elson L; Marsh, W Richard; Meyer, Fredric B; Van Gompel, Jamie J; Giannini, Caterina; Wass, C Thomas; Watson, Robert E; Worrell, Gregory A

2014-06-01

Scalp electroencephalography (EEG) and intraoperative electrocorticography (ECoG) are routinely used in the evaluation of magnetic resonance imaging-negative temporal lobe epilepsy (TLE) undergoing standard anterior temporal lobectomy with amygdalohippocampectomy (ATL), but the utility of interictal epileptiform discharge (IED) identification and its role in outcome are poorly defined. To determine whether the following are associated with surgical outcomes in patients with magnetic resonance imaging-negative TLE who underwent standard ATL: (1) unilateral-only IEDs on preoperative scalp EEG; (2) complete resection of tissue generating IEDs on ECoG; (3) complete resection of opioid-induced IEDs recorded on ECoG; and (4) location of IEDs recorded on ECoG. Data were gathered through retrospective medical record review at a tertiary referral center. Adult and pediatric patients with TLE who underwent standard ATL between January 1, 1990, and October 15, 2010, were considered for inclusion. Inclusion criteria were magnetic resonance imaging-negative TLE, standard ECoG performed at the time of surgery, and a minimum follow-up of 12 months. Univariate analysis was performed using log-rank time-to-event analysis. Variables reaching significance with log-rank testing were further analyzed using Cox proportional hazards. Excellent or nonexcellent outcome at time of last follow-up. An excellent outcome was defined as Engel class I and a nonexcellent outcome as Engel classes II through IV. Eighty-seven patients met inclusion criteria, with 48 (55%) achieving an excellent outcome following ATL. Unilateral IEDs on scalp EEG (P = .001) and complete resection of brain regions generating IEDs on baseline intraoperative ECoG (P = .02) were associated with excellent outcomes in univariate analysis. Both were associated with excellent outcomes when analyzed with Cox proportional hazards (unilateral-only IEDs, relative risk = 0.31 [95% CI, 0.16-0.64]; complete resection of IEDs on baseline ECoG, relative risk = 0.39 [95% CI, 0.20-0.76]). Overall, 25 of 35 patients (71%) with both unilateral-only IEDs and complete resection of baseline ECoG IEDs had an excellent outcome. Unilateral-only IEDs on preoperative scalp EEG and complete resection of IEDs on baseline ECoG are associated with better outcomes following standard ATL in magnetic resonance imaging-negative TLE. Prospective evaluation is needed to clarify the use of ECoG in tailoring temporal lobectomy.

EEGgui: a program used to detect electroencephalogram anomalies after traumatic brain injury.

PubMed

Sick, Justin; Bray, Eric; Bregy, Amade; Dietrich, W Dalton; Bramlett, Helen M; Sick, Thomas

2013-05-21

Identifying and quantifying pathological changes in brain electrical activity is important for investigations of brain injury and neurological disease. An example is the development of epilepsy, a secondary consequence of traumatic brain injury. While certain epileptiform events can be identified visually from electroencephalographic (EEG) or electrocorticographic (ECoG) records, quantification of these pathological events has proved to be more difficult. In this study we developed MATLAB-based software that would assist detection of pathological brain electrical activity following traumatic brain injury (TBI) and present our MATLAB code used for the analysis of the ECoG. Software was developed using MATLAB(™) and features of the open access EEGLAB. EEGgui is a graphical user interface in the MATLAB programming platform that allows scientists who are not proficient in computer programming to perform a number of elaborate analyses on ECoG signals. The different analyses include Power Spectral Density (PSD), Short Time Fourier analysis and Spectral Entropy (SE). ECoG records used for demonstration of this software were derived from rats that had undergone traumatic brain injury one year earlier. The software provided in this report provides a graphical user interface for displaying ECoG activity and calculating normalized power density using fast fourier transform of the major brain wave frequencies (Delta, Theta, Alpha, Beta1, Beta2 and Gamma). The software further detects events in which power density for these frequency bands exceeds normal ECoG by more than 4 standard deviations. We found that epileptic events could be identified and distinguished from a variety of ECoG phenomena associated with normal changes in behavior. We further found that analysis of spectral entropy was less effective in distinguishing epileptic from normal changes in ECoG activity. The software presented here was a successful modification of EEGLAB in the Matlab environment that allows detection of epileptiform ECoG signals in animals after TBI. The code allows import of large EEG or ECoG data records as standard text files and uses fast fourier transform as a basis for detection of abnormal events. The software can also be used to monitor injury-induced changes in spectral entropy if required. We hope that the software will be useful for other investigators in the field of traumatic brain injury and will stimulate future advances of quantitative analysis of brain electrical activity after neurological injury or disease.

Is there subclinical enthesitis in early psoriatic arthritis? A clinical comparison with power doppler ultrasound.

PubMed

Freeston, J E; Coates, L C; Helliwell, P S; Hensor, E M A; Wakefield, R J; Emery, P; Conaghan, P G

2012-10-01

Enthesitis is a recognized feature of spondylarthritides (SpA), including psoriatic arthritis (PsA). Previously, ultrasound imaging has highlighted the presence of subclinical enthesitis in established SpA, but there are little data on ultrasound findings in early PsA. The aim of our study was to compare ultrasound and clinical examination (CE) for the detection of entheseal abnormalities in an early PsA cohort. Forty-two patients with new-onset PsA and 10 control subjects underwent CE of entheses for tenderness and swelling, as well as gray-scale (GS) and power Doppler (PD) ultrasound of a standard set of entheses. Bilateral elbow lateral epicondyles, Achilles tendons, and plantar fascia were assessed by both CE and ultrasound, the latter scored using a semiquantitative (SQ) scale. Inferior patellar tendons were assessed by ultrasound alone. A GS SQ score of >1 and/or a PD score of >0 was used to describe significant ultrasound entheseal abnormality. A total of 24 (57.1%) of 42 patients in the PsA group and 0 (0%) of 10 controls had clinical evidence of at least 1 tender enthesis. In the PsA group, for sites assessed by both CE and ultrasound, 4% (7 of 177) of nontender entheses had a GS score >1 and/or a PD score >0 compared to 24% (9 of 37) of tender entheses. CE overestimated activity in 28 (13%) of 214 of entheses. All the nontender ultrasound-abnormal entheses were in the lower extremity. The prevalence of subclinical enthesitis in this early PsA cohort was low. CE may overestimate active enthesitis. The few subclinically inflamed entheses were in the lower extremity, where mechanical stress is likely to be more significant. Copyright © 2012 by the American College of Rheumatology.

A piecewise probabilistic regression model to decode hand movement trajectories from epidural and subdural ECoG signals

NASA Astrophysics Data System (ADS)

Farrokhi, Behraz; Erfanian, Abbas

2018-06-01

Objective. The primary concern of this study is to develop a probabilistic regression method that would improve the decoding of the hand movement trajectories from epidural ECoG as well as from subdural ECoG signals. Approach. The model is characterized by the conditional expectation of the hand position given the ECoG signals. The conditional expectation of the hand position is then modeled by a linear combination of the conditional probability density functions defined for each segment of the movement. Moreover, a spatial linear filter is proposed for reducing the dimension of the feature space. The spatial linear filter is applied to each frequency band of the ECoG signals and extract the features with highest decoding performance. Main results. For evaluating the proposed method, a dataset including 28 ECoG recordings from four adult Japanese macaques is used. The results show that the proposed decoding method outperforms the results with respect to the state of the art methods using this dataset. The relative kinematic information of each frequency band is also investigated using mutual information and decoding performance. The decoding performance shows that the best performance was obtained for high gamma bands from 50 to 200 Hz as well as high frequency ECoG band from 200 to 400 Hz for subdural recordings. However, the decoding performance was decreased for these frequency bands using epidural recordings. The mutual information shows that, on average, the high gamma band from 50 to 200 Hz and high frequency ECoG band from 200 to 400 Hz contain significantly more information than the average of the rest of the frequency bands ≤ft( p<0.001 \\right) for both subdural and epidural recordings. The results of high resolution time-frequency analysis show that ERD/ERS patterns in all frequency bands could reveal the dynamics of the ECoG responses during the movement. The onset and offset of the movement can be clearly identified by the ERD/ERS patterns. Significance. Reliable decoding the kinematic information from the brain signals paves the way for robust control of external devices.

Applications of propensity score methods in observational comparative effectiveness and safety research: where have we come and where should we go?

PubMed

Borah, Bijan J; Moriarty, James P; Crown, William H; Doshi, Jalpa A

2014-01-01

Propensity score (PS) methods have proliferated in recent years in observational studies in general and in observational comparative effectiveness research (CER) in particular. PS methods are an important set of tools for estimating treatment effects in observational studies, enabling adjustment for measured confounders in an easy-to-understand and transparent way. This article demonstrates how PS methods have been used to address specific CER questions from 2001 through to 2012 by identifying six impactful studies from this period. This article also discusses areas for improvement, including data infrastructure, and a unified set of guidelines in terms of PS implementation and reporting, which will boost confidence in evidence generated through observational CER using PS methods.

Adaptation of Chinese and English versions of the Psoriatic Arthritis Quality of Life (PsAQoL) scale for use in Singapore.

PubMed

Leung, Ying Ying; Thumboo, Julian; Rouse, Matthew; McKenna, Stephen P

2016-10-18

To develop Singapore Chinese and English versions of the Psoriatic Arthritis Quality of Life (PsAQoL) scale that were equivalent to and met the same psychometric and acceptability standards as the original UK measure. Translation of the original PsAQoL into contextualised English and Chinese versions for use in Singapore was performed by professional and lay translation panels. Ten Chinese speaking and ten English speaking local patients were interviewed to assess face and content validity. Psoriatic arthritis (PsA) patients (either Chinese or English speaking) fulfilling the Classification criteria of Psoriatic Arthritis were then invited to participate in a validation survey. Clinical variables, the Health Assessment Questionnaire (HAQ) and the Medical Outcome Short-form 36 (SF-36) were used as comparator instruments for convergent validity. A separate sample of PsA patients were invited to participate in a test-retest postal study, with two weeks between administrations. The validation sample included 98 patients (51 % men) with a mean (SD) age of 51.5 (13.8) years. The PsAQoL had excellent internal consistency (Cronbach's α = 0.92) and scores on the measure were moderately correlated with health status measures (pain, HAQ score, SF-36 scores) and patient and physician global assessments. The scale was able to distinguish between groups with active or inactive disease assessed by composite scores, HAQ and minimal disease activity. Test-retest reliability was excellent (r = 0.92). This study provides evidence that the adapted English and Chinese versions of the PsAQoL can be used in clinical studies with PsA patients in Singapore.

Relationship between inpatient satisfaction and nurse absenteeism: an exploratory study using WHO-PATH performance indicators in France

PubMed Central

2012-01-01

Background Indicators describing results of care are widely explored in term of patient satisfaction (PS). Among factors explaining PS, human resources indicators have been studied in terms of burnout or job satisfaction among healthcare professionals. No research work has set out to explore the effect of absenteeism on PS scores. The objective of this study was to explore interaction between rate of absenteeism among nurses and PS results. Methods France has taken part in a project named PATH (Performance Assessment Tool for Hospitals) of the World Health Organization, aiming to develop a tool for the assessment of hospital performance. In the first semester 2008, 25 volunteering short-stay hospitals (teaching, general and private) provide complete data on nurse short-absenteeism (periods of up to 7 consecutive days of sick leave) and on PS (a cross-sectional postal survey using a standardized validated French-language scale EQS-H exploring "quality of medical information" (MI) and "relationships with staff and daily routine" (RS)). A multi-level model was used to take into account of the hierarchical nature of the data. Results Two thousand and sixty-five patients responded to the satisfaction questionnaire (participation rate: 40.9%). The mean age of respondents was 58 yrs (± 19), 41% were men. The mean duration of hospitalisation was 7.5 days (± 11.1). The mean absenteeism rate for nurses was 0.24% (± 0.14). All the PS scores were significantly and negatively correlated with rate of short-absenteeism among nurses (MI score: ρ = -0.55, p < 0.01), RS score ρ = -0.47, p = 0.02). The mixed model found a significant relationship between rate of absenteeism among nurses and PS scores (MI: p = 0.027; RS: p = 0.017). Conclusion Results obtained in this study show that short-term absenteeism among nurses seems to be significantly and negatively correlated with PS. Our findings are an invitation to deepen our understanding of the impact of human resources on PS and to develop more specific projects. PMID:22293709

Relationship between inpatient satisfaction and nurse absenteeism: an exploratory study using WHO-PATH performance indicators in France.

PubMed

Moret, Leila; Anthoine, Emmanuelle; Paillé, Cécile; Tricaud-Vialle, Sophie; Gerbaud, Laurent; Giraud-Roufast, Alexandra; Michel, Philippe; Lombrail, Pierre

2012-01-31

Indicators describing results of care are widely explored in term of patient satisfaction (PS). Among factors explaining PS, human resources indicators have been studied in terms of burnout or job satisfaction among healthcare professionals. No research work has set out to explore the effect of absenteeism on PS scores. The objective of this study was to explore interaction between rate of absenteeism among nurses and PS results. France has taken part in a project named PATH (Performance Assessment Tool for Hospitals) of the World Health Organization, aiming to develop a tool for the assessment of hospital performance. In the first semester 2008, 25 volunteering short-stay hospitals (teaching, general and private) provide complete data on nurse short-absenteeism (periods of up to 7 consecutive days of sick leave) and on PS (a cross-sectional postal survey using a standardized validated French-language scale EQS-H exploring "quality of medical information" (MI) and "relationships with staff and daily routine" (RS)). A multi-level model was used to take into account of the hierarchical nature of the data. Two thousand and sixty-five patients responded to the satisfaction questionnaire (participation rate: 40.9%). The mean age of respondents was 58 yrs (± 19), 41% were men. The mean duration of hospitalisation was 7.5 days (± 11.1). The mean absenteeism rate for nurses was 0.24% (± 0.14).All the PS scores were significantly and negatively correlated with rate of short-absenteeism among nurses (MI score: ρ = -0.55, p < 0.01), RS score ρ = -0.47, p = 0.02). The mixed model found a significant relationship between rate of absenteeism among nurses and PS scores (MI: p = 0.027; RS: p = 0.017). Results obtained in this study show that short-term absenteeism among nurses seems to be significantly and negatively correlated with PS. Our findings are an invitation to deepen our understanding of the impact of human resources on PS and to develop more specific projects.

Confronting ‘confounding by health system use’ in Medicare Part D: Comparative effectiveness of propensity score approaches to confounding adjustment

PubMed Central

Polinski, Jennifer M.; Schneeweiss, Sebastian; Glynn, Robert J.; Lii, Joyce; Rassen, Jeremy

2012-01-01

Purpose Under Medicare Part D, patient characteristics influence plan choice, which in turn influences Part D coverage gap entry. We compared pre-defined propensity score (PS) and high-dimensional propensity score (hdPS) approaches to address such ‘confounding by health system use’ in assessing whether coverage gap entry is associated with cardiovascular events or death. Methods We followed 243,079 Medicare patients aged 65+ with linked prescription, medical, and plan-specific data in 2005–2007. Patients reached the coverage gap and were followed until an event or year’s end. Exposed patients were responsible for drug costs in the gap; unexposed patients (patients with non-Part D drug insurance and Part D patients receiving a low-income subsidy (LIS)) received financial assistance. Exposed patients were 1:1 PS- or hdPS-matched to unexposed patients. The PS model included 52 predefined covariates; the hdPS model added 400 empirically identified covariates. Hazard ratios for death and any of five cardiovascular outcomes were compared. In sensitivity analyses, we explored residual confounding using only LIS patients in the unexposed group. Results In unadjusted analyses, exposed patients had no greater hazard of death (HR=1.00; 95% CI, 0.84–1.20) or other outcomes. PS- (HR=1.29;0.99–1.66) and hdPS- (HR=1.11;0.86–1.42) matched analyses showed elevated but non-significant hazards of death. In sensitivity analyses, the PS analysis showed a protective effect (HR=0.78;0.61–0.98), while the hdPS analysis (HR=1.06;0.82–1.37) confirmed the main hdPS findings. Conclusion Although the PS-matched analysis suggested elevated though non-significant hazards of death among patients with no financial assistance during the gap, the hdPS analysis produced lower estimates that were stable across sensitivity analyses. PMID:22552984

Evaluation of the Physiological and Operative Severity Score for the Enumeration of Mortality and Morbidity (POSSUM) scoring system in elderly patients with pressure sores undergoing fasciocutaneous flap-reconstruction.

PubMed

Mizumoto, Kazuo; Morita, Eishin

2009-01-01

The aim of the present study was to predict operative morbidity in elderly patients with deep pressure sores by using the Physiological and Operative Severity Score for the Enumeration of Mortality and Morbidity (POSSUM) scoring system. Fifteen patients over 70 years old were retrospectively reviewed who had undergone gluteus maximus fasciocutaneous flap-reconstruction for pressure sores of the sacral region from 1 April 2005 to 31 March 2007. Complications were seen in six cases (40%) after operation. Four were wound infection, one was chest infection and another was septicemia. The subjects were divided into two groups by the presence (complicated group) or absence (non-complicated group) of postoperative complications. Each item of physiological scores, physiological score (PS), operative severity score (OS) and predicted morbidity rate (R) were calculated and compared between two groups. As a result, hemoglobin (P = 0.0276), PS (P = 0.0023) and R (P = 0.0078) differed significantly between the two groups. It is noteworthy that the PS were over 25 in all of the complicated group, but in only one of nine in the non-complicated group (P = 0.0014). Our study suggests that, for pressure sores in the sacral region in elderly patients, gluteus maximus fasciocutaneous flap-reconstruction can be employed in patients whose PS are under 24 in the POSSUM scoring system.

Genome-Wide Association Studies for Taxane-Induced Peripheral Neuropathy in ECOG-5103 and ECOG-1199.

PubMed

Schneider, Bryan P; Li, Lang; Radovich, Milan; Shen, Fei; Miller, Kathy D; Flockhart, David A; Jiang, Guanglong; Vance, Gail; Gardner, Laura; Vatta, Matteo; Bai, Shaochun; Lai, Dongbing; Koller, Daniel; Zhao, Fengmin; O'Neill, Anne; Smith, Mary Lou; Railey, Elda; White, Carol; Partridge, Ann; Sparano, Joseph; Davidson, Nancy E; Foroud, Tatiana; Sledge, George W

2015-11-15

Taxane-induced peripheral neuropathy (TIPN) is an important survivorship issue for many cancer patients. Currently, there are no clinically implemented biomarkers to predict which patients might be at increased risk for TIPN. We present a comprehensive approach to identification of genetic variants to predict TIPN. We performed a genome-wide association study (GWAS) in 3,431 patients from the phase III adjuvant breast cancer trial, ECOG-5103 to compare genotypes with TIPN. We performed candidate validation of top SNPs for TIPN in another phase III adjuvant breast cancer trial, ECOG-1199. When evaluating for grade 3-4 TIPN, 120 SNPs had a P value of <10(-4) from patients of European descent (EA) in ECOG-5103. Thirty candidate SNPs were subsequently tested in ECOG-1199 and SNP rs3125923 was found to be significantly associated with grade 3-4 TIPN (P = 1.7 × 10(-3); OR, 1.8). Race was also a major predictor of TIPN, with patients of African descent (AA) experiencing increased risk of grade 2-4 TIPN (HR, 2.1; P = 5.6 × 10(-16)) and grade 3-4 TIPN (HR, 2.6; P = 1.1 × 10(-11)) compared with others. An SNP in FCAMR, rs1856746, had a trend toward an association with grade 2-4 TIPN in AA patients from the GWAS in ECOG-5103 (OR, 5.5; P = 1.6 × 10(-7)). rs3125923 represents a validated SNP to predict grade 3-4 TIPN. Genetically determined AA race represents the most significant predictor of TIPN. ©2015 American Association for Cancer Research.

Interictal Scalp Electroencephalography and Intraoperative Electrocorticography in Magnetic Resonance Imaging–Negative Temporal Lobe Epilepsy Surgery

PubMed Central

Burkholder, David B.; Sulc, Vlastimil; Hoffman, E. Matthew; Cascino, Gregory D.; Britton, Jeffrey W.; So, Elson L.; Marsh, W. Richard; Meyer, Fredric B.; Van Gompel, Jamie J.; Giannini, Caterina; Wass, C. Thomas; Watson, Robert E.; Worrell, Gregory A.

2014-01-01

IMPORTANCE Scalp electroencephalography (EEG) and intraoperative electrocorticography (ECoG) are routinely used in the evaluation of magnetic resonance imaging–negative temporal lobe epilepsy (TLE) undergoing standard anterior temporal lobectomy with amygdalohippocampectomy (ATL), but the utility of interictal epileptiform discharge (IED) identification and its role in outcome are poorly defined. OBJECTIVES To determine whether the following are associated with surgical outcomes in patients with magnetic resonance imaging–negative TLE who underwent standard ATL: (1) unilateral-only IEDs on preoperative scalp EEG; (2) complete resection of tissue generating IEDs on ECoG; (3) complete resection of opioid-induced IEDs recorded on ECoG; and (4) location of IEDs recorded on ECoG. DESIGN, SETTING, AND PARTICIPANTS Data were gathered through retrospective medical record review at a tertiary referral center. Adult and pediatric patients with TLE who underwent standard ATL between January 1, 1990, and October 15, 2010, were considered for inclusion. Inclusion criteria were magnetic resonance imaging–negative TLE, standard ECoG performed at the time of surgery, and a minimum follow-up of 12 months. Univariate analysis was performed using log-rank time-to-event analysis. Variables reaching significance with log-rank testing were further analyzed using Cox proportional hazards. MAIN OUTCOMES AND MEASURES Excellent or nonexcellent outcome at time of last follow-up. An excellent outcome was defined as Engel class I and a nonexcellent outcome as Engel classes II through IV. RESULTS Eighty-seven patients met inclusion criteria, with 48 (55%) achieving an excellent outcome following ATL. Unilateral IEDs on scalp EEG (P = .001) and complete resection of brain regions generating IEDs on baseline intraoperative ECoG (P = .02) were associated with excellent outcomes in univariate analysis. Both were associated with excellent outcomes when analyzed with Cox proportional hazards (unilateral-only IEDs, relative risk = 0.31 [95% CI, 0.16-0.64]; complete resection of IEDs on baseline ECoG, relative risk = 0.39 [95% CI, 0.20-0.76]). Overall, 25 of 35 patients (71%) with both unilateral-only IEDs and complete resection of baseline ECoG IEDs had an excellent outcome. CONCLUSIONS AND RELEVANCE Unilateral-only IEDs on preoperative scalp EEG and complete resection of IEDs on baseline ECoG are associated with better outcomes following standard ATL in magnetic resonance imaging–negative TLE. Prospective evaluation is needed to clarify the use of ECoG in tailoring temporal lobectomy. PMID:24781216

Best (but oft-forgotten) practices: propensity score methods in clinical nutrition research.

PubMed

Ali, M Sanni; Groenwold, Rolf Hh; Klungel, Olaf H

2016-08-01

In observational studies, treatment assignment is a nonrandom process and treatment groups may not be comparable in their baseline characteristics, a phenomenon known as confounding. Propensity score (PS) methods can be used to achieve comparability of treated and nontreated groups in terms of their observed covariates and, as such, control for confounding in estimating treatment effects. In this article, we provide a step-by-step guidance on how to use PS methods. For illustrative purposes, we used simulated data based on an observational study of the relation between oral nutritional supplementation and hospital length of stay. We focused on the key aspects of PS analysis, including covariate selection, PS estimation, covariate balance assessment, treatment effect estimation, and reporting. PS matching, stratification, covariate adjustment, and weighting are discussed. R codes and example data are provided to show the different steps in a PS analysis. © 2016 American Society for Nutrition.

A practical guide to propensity score analysis for applied clinical research.

PubMed

Lee, Jaehoon; Little, Todd D

2017-11-01

Observational studies are often the only viable options in many clinical settings, especially when it is unethical or infeasible to randomly assign participants to different treatment régimes. In such case propensity score (PS) analysis can be applied to accounting for possible selection bias and thereby addressing questions of causal inference. Many PS methods exist, yet few guidelines are available to aid applied researchers in their conduct and evaluation of a PS analysis. In this article we give an overview of available techniques for PS estimation and application, balance diagnostic, treatment effect estimation, and sensitivity assessment, as well as recent advances. We also offer a tutorial that can be used to emulate the steps of PS analysis. Our goal is to provide information that will bring PS analysis within the reach of applied clinical researchers and practitioners. Copyright © 2017 Elsevier Ltd. All rights reserved.

Statistical primer: propensity score matching and its alternatives.

PubMed

Benedetto, Umberto; Head, Stuart J; Angelini, Gianni D; Blackstone, Eugene H

2018-06-01

Propensity score (PS) methods offer certain advantages over more traditional regression methods to control for confounding by indication in observational studies. Although multivariable regression models adjust for confounders by modelling the relationship between covariates and outcome, the PS methods estimate the treatment effect by modelling the relationship between confounders and treatment assignment. Therefore, methods based on the PS are not limited by the number of events, and their use may be warranted when the number of confounders is large, or the number of outcomes is small. The PS is the probability for a subject to receive a treatment conditional on a set of baseline characteristics (confounders). The PS is commonly estimated using logistic regression, and it is used to match patients with similar distribution of confounders so that difference in outcomes gives unbiased estimate of treatment effect. This review summarizes basic concepts of the PS matching and provides guidance in implementing matching and other methods based on the PS, such as stratification, weighting and covariate adjustment.

Comparative analysis of disease activity measures, use of biologic agents, body mass index, radiographic features, and bone density in psoriatic arthritis and rheumatoid arthritis patients followed in a large U.S. disease registry.

PubMed

Reddy, Soumya M; Anandarajah, Allen P; Fisher, Mark C; Mease, Philip J; Greenberg, Jeffrey D; Kremer, Joel M; Reed, George; Chen, Rui; Messing, Susan; Kaukeinen, Kimberly; Ritchlin, Christopher T

2010-12-01

To compare disease activity, radiographic features, and bone density in psoriatic arthritis (PsA) and rheumatoid arthritis (RA) matched cohorts. Disease activity and radiographic data in the Consortium of Rheumatology Researchers of North America database from 2001 to 2008 were compared for 2481 patients with PsA and 17,107 patients with RA subsequently matched for age, gender, and disease duration. Radiographic outcomes included presence of erosions, and joint deformity. In addition, bone mineral density (BMD) scores for lumbar spine (L-spine) and femoral neck were compared using the same matching criteria plus weight and smoking status. Tender (4.5 vs 3.4, p < 0.001) and swollen (4.4 vs 2.9, p < 0.012) joint counts, and modified Health Assessment Questionnaire scores were significantly higher (0.4 vs 0.3, p < 0.001) in patients with RA compared with patients with PsA. Patient general health and pain scores were also higher in patients with RA vs patients with PsA. Joint erosions (47.4% vs 37.6%, p = 0.020) and deformity (25.2% vs 21.6%, p = 0.021) were more prevalent in RA than PsA. In multivariate analysis, a reduced prevalence of erosions in PsA vs RA was noted (OR 0.609, p < 0.001). After matching, T-scores for L-spine (-0.54 vs -0.36, p = 0.077) and femoral neck (-0.88 vs -0.93, p = 0.643) were similar in patients with RA and patients with PsA, although body weight was a major confounder. The level of disease activity and radiographic damage was significantly higher for RA vs PsA subjects, although the magnitude of differences was relatively small. BMD levels were comparable between cohorts. Outcomes in patients with PsA and patients with RA may be more similar than previously reported.

Modification of a sonographic enthesitis score to differentiate between psoriatic arthritis and young healthy volunteers.

PubMed

Wervers, K; Vis, M; Rasappu, N; van der Ven, M; Tchetverikov, I; Kok, M R; Gerards, A H; Hazes, Jmw; Luime, J J

2018-01-02

We aimed to describe sonographic structural and inflammatory changes in entheses of patients with recently diagnosed psoriatic arthritis (PsA), patients with established PsA, and young healthy volunteers, and to investigate whether the MAdrid Sonographic Enthesitis Index (MASEI) enables us to distinguish these groups in an extreme comparison. New and established PsA patients and healthy volunteers (aged 20-30 years) were recruited. The triceps, quadriceps, patellar, Achilles and elbow extensor tendon insertion, and plantar fascia entheses were investigated sonographically for structural changes, erosions, calcifications, increased thickness, bursitis, and power Doppler (PD) signal according to the MASEI. The study included 25 new and 25 established PsA patients, and 25 healthy volunteers. Increased thickness and PD signal in knee entheses were common for patients and healthy volunteers, while changes at other locations predominantly occurred in patients only. PD was recoded (1, one spot; 1.5, two or three spots; 2, confluent signal; 3, severe confluent signal) and thickness of knee entheses excluded. This resulted in different modified MASEI scores between PsA patients and young healthy controls: median (interquartile range) modified MASEI of 13 (10-22.5) in new PsA, 13.5 (9.5-18) in established PsA, and 3 (1-8.5) in healthy volunteers (p = 0.002). Structural ultrasound changes and PD in entheses are common in both new and established PsA and healthy controls. MASEI score did not differentiate PsA patients from young healthy volunteers. After recoding of PD severity and excluding thickness of knee entheses, marked differences between PsA patients and healthy controls were observed.

Propensity Score Matching within Prognostic Strata

ERIC Educational Resources Information Center

Kelcey, Ben

2013-01-01

A central issue in nonexperimental studies is identifying comparable individuals to remove selection bias. One common way to address this selection bias is through propensity score (PS) matching. PS methods use a model of the treatment assignment to reduce the dimensionality of the covariate space and identify comparable individuals. parallel to…

Multilevel Propensity Score Matching within and across Schools

ERIC Educational Resources Information Center

Kelcey, Benjamin

2011-01-01

A central issue in nonexperimental studies is the identification of comparable individuals (e.g. students) to remove selection bias. One such increasingly common method to identify comparable individuals and address selection bias is the propensity score (PS). PS methods rely on a model of the treatment assignment to identify comparable…

Applying Propensity Score Methods in Medical Research: Pitfalls and Prospects

PubMed Central

Luo, Zhehui; Gardiner, Joseph C.; Bradley, Cathy J.

2012-01-01

The authors review experimental and nonexperimental causal inference methods, focusing on assumptions for the validity of instrumental variables and propensity score (PS) methods. They provide guidance in four areas for the analysis and reporting of PS methods in medical research and selectively evaluate mainstream medical journal articles from 2000 to 2005 in the four areas, namely, examination of balance, overlapping support description, use of estimated PS for evaluation of treatment effect, and sensitivity analyses. In spite of the many pitfalls, when appropriately evaluated and applied, PS methods can be powerful tools in assessing average treatment effects in observational studies. Appropriate PS applications can create experimental conditions using observational data when randomized controlled trials are not feasible and, thus, lead researchers to an efficient estimator of the average treatment effect. PMID:20442340

A new prognostic score for elderly patients with diffuse large B-cell lymphoma treated with R-CHOP: the prognostic role of blood monocyte and lymphocyte counts is absent.

PubMed

Procházka, Vít; Pytlík, Robert; Janíková, Andrea; Belada, David; Sálek, David; Papajík, Tomáš; Campr, Vít; Fürst, Tomáš; Furstova, Jana; Trněný, Marek

2014-01-01

Absolute lymphocyte count (ALC) and absolute monocyte count (AMC) have been documented as independent predictors of survival in patients with newly diagnosed Diffuse Large B-cell Lymphoma (DLBCL). Analysis of the prognostic impact of ALC and AMC in the context of International Prognostic Index (IPI) and other significant variables in elderly population treated in the R-CHOP regime has not been carried out yet. In this retrospective study, a cohort of 443 newly diagnosed DLBCL patients with age ≥ 60 was analyzed. All patients were treated with the R-CHOP therapy. An extensive statistical analysis was performed to identify risk factors of 3-year overall survival (OS). In multivariate analysis, only three predictors proved significant: Eastern Cooperative Oncology Group performance status (ECOG), age and bulky disease presence. These predictors were dichotomized (ECOG ≥ 1, age ≥ 70, bulk ≥ 7.5) to create a novel four-level score. This score predicted 3-year OS of 94.0%, 77.4%, 62.7% and 35.4% in the low-, low-intermediate, high-intermediate and high-risk groups, respectively (P<0.001). Further, a three-level score was tested which stratifies the population better (3-year OS: 91.9%, 67.2%, 36.2% in the low, intermediate and high-risk groups, respectively) but is more difficult to interpret. Both the 3- and 4-level scores were compared to standard scoring systems and, in our population, were shown to be superior in terms of patients risk stratification with respect to 3-year OS prediction. The results were successfully validated on an independent cohort of 162 patients of similar group characteristics. The prognostic role of baseline ALC, AMC or their ratio (LMR) was not confirmed in the multivariate context in elderly population with DLBCL treated with R-CHOP. The newly proposed age-specific index stratifies the elderly population into risk groups more precisely than the conventional IPI and its existing variants.

Electrocorticographic high gamma activity versus electrical cortical stimulation mapping of naming.

PubMed

Sinai, Alon; Bowers, Christopher W; Crainiceanu, Ciprian M; Boatman, Dana; Gordon, Barry; Lesser, Ronald P; Lenz, Frederick A; Crone, Nathan E

2005-07-01

Subdural electrocorticographic (ECoG) recordings in patients undergoing epilepsy surgery have shown that functional activation is associated with event-related broadband gamma activity in a higher frequency range (>70 Hz) than previously studied in human scalp EEG. To investigate the utility of this high gamma activity (HGA) for mapping language cortex, we compared its neuroanatomical distribution with functional maps derived from electrical cortical stimulation (ECS), which remains the gold standard for predicting functional impairment after surgery for epilepsy, tumours or vascular malformations. Thirteen patients had undergone subdural electrode implantation for the surgical management of intractable epilepsy. Subdural ECoG signals were recorded while each patient verbally named sequentially presented line drawings of objects, and estimates of event-related HGA (80-100 Hz) were made at each recording site. Routine clinical ECS mapping used a subset of the same naming stimuli at each cortical site. If ECS disrupted mouth-related motor function, i.e. if it affected the mouth, lips or tongue, naming could not be tested with ECS at the same cortical site. Because naming during ECoG involved these muscles of articulation, the sensitivity and specificity of ECoG HGA were estimated relative to both ECS-induced impairments of naming and ECS disruption of mouth-related motor function. When these estimates were made separately for 12 electrode sites per patient (the average number with significant HGA), the specificity of ECoG HGA with respect to ECS was 78% for naming and 81% for mouth-related motor function, and equivalent sensitivities were 38% and 46%, respectively. When ECS maps of naming and mouth-related motor function were combined, the specificity and sensitivity of ECoG HGA with respect to ECS were 84% and 43%, respectively. This study indicates that event-related ECoG HGA during confrontation naming predicts ECS interference with naming and mouth-related motor function with good specificity but relatively low sensitivity. Its favourable specificity suggests that ECoG HGA can be used to construct a preliminary functional map that may help identify cortical sites of lower priority for ECS mapping. Passive recordings of ECoG gamma activity may be done simultaneously at all electrode sites without the risk of after-discharges associated with ECS mapping, which must be done sequentially at pairs of electrodes. We discuss the relative merits of these two functional mapping techniques.

Clinical characteristics, surgical and neuropsychological outcomes in drug resistant tumoral temporal lobe epilepsy.

PubMed

Ravat, Sangeeta; Iyer, Vivek; Muzumdar, Dattatraya; Shah, Urvashi; Pradhan, Pranjali; Jain, Neeraj; Godge, Yogesh

2016-12-01

Glioneuronal tumors are found in nearly one third patients who undergo surgery for pharmacoresistant epilepsy with temporal lobe being the most common location. Few studies, however have concentrated on the neurological and neuropsychological outcomes after surgery, hitherto none from India. We studied 34 patients with temporal lobe tumors and drug resistant epilepsy. These patients underwent anterior temporal lobectomy or lesionectomy based on the involvement of the hippocampus and mesial temporal structures. The clinical history, EEG, neuropsychology profile and MRI were compared. Seizure outcome was categorized using Engel's classification. At a mean follow up of 62 months, 85.29% of the patients were seizure free (Engel's Class I). All 8 patients with intraoperative electrocorticography (ECoG) guided resection were seizure free. Presence of a residual lesion was significantly associated with persistence of seizures post surgery (p = 0.002). Group analysis revealed no significant shifts in IQ and memory scores postoperatively. There was a significant improvement in the quality of life scores (total and across all subdomains) in all patients (p < 0.001). Postoperative EEG abnormalities predicted unfavorable ​seizure outcome. Surgery for temporal lobe tumors and refractory epilepsy offers complete seizure freedom in majority. Complete surgical excision of the epileptogenic zone is of paramount importance in achieving seizure freedom. Intraoperative electrocorticography (EcoG) is a useful adjunct to ensure complete removal of epileptogenic zone, thus achieving optimal seizure freedom. There is a significant improvement in the quality of life scores (p < 0.001) with no negative impact of surgery on memory and intelligence. Even the patients who are not seizure free can achieve worthwhile improvement post surgery. Copyright © 2015 IJS Publishing Group Ltd. Published by Elsevier Ltd. All rights reserved.

Intrasulcal Electrocorticography in Macaque Monkeys with Minimally Invasive Neurosurgical Protocols

PubMed Central

Matsuo, Takeshi; Kawasaki, Keisuke; Osada, Takahiro; Sawahata, Hirohito; Suzuki, Takafumi; Shibata, Masahiro; Miyakawa, Naohisa; Nakahara, Kiyoshi; Iijima, Atsuhiko; Sato, Noboru; Kawai, Kensuke; Saito, Nobuhito; Hasegawa, Isao

2011-01-01

Electrocorticography (ECoG), multichannel brain-surface recording and stimulation with probe electrode arrays, has become a potent methodology not only for clinical neurosurgery but also for basic neuroscience using animal models. The highly evolved primate's brain has deep cerebral sulci, and both gyral and intrasulcal cortical regions have been implicated in important functional processes. However, direct experimental access is typically limited to gyral regions, since placing probes into sulci is difficult without damaging the surrounding tissues. Here we describe a novel methodology for intrasulcal ECoG in macaque monkeys. We designed and fabricated ultra-thin flexible probes for macaques with micro-electro-mechanical systems technology. We developed minimally invasive operative protocols to implant the probes by introducing cutting-edge devices for human neurosurgery. To evaluate the feasibility of intrasulcal ECoG, we conducted electrophysiological recording and stimulation experiments. First, we inserted parts of the Parylene-C-based probe into the superior temporal sulcus to compare visually evoked ECoG responses from the ventral bank of the sulcus with those from the surface of the inferior temporal cortex. Analyses of power spectral density and signal-to-noise ratio revealed that the quality of the ECoG signal was comparable inside and outside of the sulcus. Histological examination revealed no obvious physical damage in the implanted areas. Second, we placed a modified silicone ECoG probe into the central sulcus and also on the surface of the precentral gyrus for stimulation. Thresholds for muscle twitching were significantly lower during intrasulcal stimulation compared to gyral stimulation. These results demonstrate the feasibility of intrasulcal ECoG in macaques. The novel methodology proposed here opens up a new frontier in neuroscience research, enabling the direct measurement and manipulation of electrical activity in the whole brain. PMID:21647392

Language Mapping in Multilingual Patients: Electrocorticography and Cortical Stimulation During Naming

PubMed Central

Cervenka, Mackenzie C.; Boatman-Reich, Dana F.; Ward, Julianna; Franaszczuk, Piotr J.; Crone, Nathan E.

2011-01-01

Multilingual patients pose a unique challenge when planning epilepsy surgery near language cortex because the cortical representations of each language may be distinct. These distinctions may not be evident with routine electrocortical stimulation mapping (ESM). Electrocorticography (ECoG) has recently been used to detect task-related spectral perturbations associated with functional brain activation. We hypothesized that using broadband high gamma augmentation (HGA, 60–150 Hz) as an index of cortical activation, ECoG would complement ESM in discriminating the cortical representations of first (L1) and second (L2) languages. We studied four adult patients for whom English was a second language, in whom subdural electrodes (a total of 358) were implanted to guide epilepsy surgery. Patients underwent ECoG recordings and ESM while performing the same visual object naming task in L1 and L2. In three of four patients, ECoG found sites activated during naming in one language but not the other. These language-specific sites were not identified using ESM. In addition, ECoG HGA was observed at more sites during L2 versus L1 naming in two patients, suggesting that L2 processing required additional cortical resources compared to L1 processing in these individuals. Post-operative language deficits were identified in three patients (one in L2 only). These deficits were predicted by ECoG spectral mapping but not by ESM. These results suggest that pre-surgical mapping should include evaluation of all utilized languages to avoid post-operative functional deficits. Finally, this study suggests that ECoG spectral mapping may potentially complement the results of ESM of language. PMID:21373361

Spreading Depolarizations of Cerebral Cortex After Brain Injury: Mechanism of Injury Progression and Relevance to Military Neurotrauma

DTIC Science & Technology

2006-11-01

sustained penetrating brain injury (PBI). Emergency craniotomies are performed to treat these severe injuries in theater, sometimes on a daily...after craniotomy surgery. ECoG recordings were made subsequently for 1-10 days. CSD was identified by rapidly developing depression of ECoG amplitude...treat patients with moderate-to-severe TBI provides the opportunity to monitor for CSD by ECoG recordings. In these cases, craniotomy is performed as

Neural correlates of high-gamma oscillations (60–200 Hz) in macaque local field potentials and their potential implications in electrocorticography

PubMed Central

Crone, Nathan E.; Niebur, Ernst; Franaszczuk, Piotr J.; Hsiao, Steven S.

2009-01-01

Recent studies using electrocorticographic (ECoG) recordings in humans have shown that functional activation of cortex is associated with an increase in power in the high-gamma frequency range (∼60–200 Hz). Here we investigate the neural correlates of this high-gamma activity in local field potential (LFP). Single units and LFP were recorded with microelectrodes from the hand region of macaque SII cortex while vibrotactile stimuli of varying intensities were presented to the hand. We found that high-gamma power in the LFP was strongly correlated with the average firing rate recorded by the microelectrodes, both temporally and on a trial-by-trial basis. In comparison, the correlation between firing rate and low-gamma power (40–80 Hz) was much smaller. In order to explore the potential effects of neuronal firing on ECoG, we developed a model to estimate ECoG power generated by different firing patterns of the underlying cortical population and studied how ECoG power varies with changes in firing rate versus the degree of synchronous firing between neurons in the population. Both an increase in firing rate and neuronal synchrony increased high-gamma power in the simulated ECoG data. However, ECoG high-gamma activity was much more sensitive to increases in neuronal synchrony than firing rate. PMID:18987189

Unsupervised Online Classifier in Sleep Scoring for Sleep Deprivation Studies

PubMed Central

Libourel, Paul-Antoine; Corneyllie, Alexandra; Luppi, Pierre-Hervé; Chouvet, Guy; Gervasoni, Damien

2015-01-01

Study Objective: This study was designed to evaluate an unsupervised adaptive algorithm for real-time detection of sleep and wake states in rodents. Design: We designed a Bayesian classifier that automatically extracts electroencephalogram (EEG) and electromyogram (EMG) features and categorizes non-overlapping 5-s epochs into one of the three major sleep and wake states without any human supervision. This sleep-scoring algorithm is coupled online with a new device to perform selective paradoxical sleep deprivation (PSD). Settings: Controlled laboratory settings for chronic polygraphic sleep recordings and selective PSD. Participants: Ten adult Sprague-Dawley rats instrumented for chronic polysomnographic recordings Measurements: The performance of the algorithm is evaluated by comparison with the score obtained by a human expert reader. Online detection of PS is then validated with a PSD protocol with duration of 72 hours. Results: Our algorithm gave a high concordance with human scoring with an average κ coefficient > 70%. Notably, the specificity to detect PS reached 92%. Selective PSD using real-time detection of PS strongly reduced PS amounts, leaving only brief PS bouts necessary for the detection of PS in EEG and EMG signals (4.7 ± 0.7% over 72 h, versus 8.9 ± 0.5% in baseline), and was followed by a significant PS rebound (23.3 ± 3.3% over 150 minutes). Conclusions: Our fully unsupervised data-driven algorithm overcomes some limitations of the other automated methods such as the selection of representative descriptors or threshold settings. When used online and coupled with our sleep deprivation device, it represents a better option for selective PSD than other methods like the tedious gentle handling or the platform method. Citation: Libourel PA, Corneyllie A, Luppi PH, Chouvet G, Gervasoni D. Unsupervised online classifier in sleep scoring for sleep deprivation studies. SLEEP 2015;38(5):815–828. PMID:25325478

Hierarchical Spatio-temporal Visual Analysis of Cluster Evolution in Electrocorticography Data

DOE PAGES

Murugesan, Sugeerth; Bouchard, Kristofer; Chang, Edward; ...

2016-10-02

Here, we present ECoG ClusterFlow, a novel interactive visual analysis tool for the exploration of high-resolution Electrocorticography (ECoG) data. Our system detects and visualizes dynamic high-level structures, such as communities, using the time-varying spatial connectivity network derived from the high-resolution ECoG data. ECoG ClusterFlow provides a multi-scale visualization of the spatio-temporal patterns underlying the time-varying communities using two views: 1) an overview summarizing the evolution of clusters over time and 2) a hierarchical glyph-based technique that uses data aggregation and small multiples techniques to visualize the propagation of clusters in their spatial domain. ECoG ClusterFlow makes it possible 1) tomore » compare the spatio-temporal evolution patterns across various time intervals, 2) to compare the temporal information at varying levels of granularity, and 3) to investigate the evolution of spatial patterns without occluding the spatial context information. Lastly, we present case studies done in collaboration with neuroscientists on our team for both simulated and real epileptic seizure data aimed at evaluating the effectiveness of our approach.« less

Acne vulgaris in early adolescent boys. Correlations with pubertal maturation and age.

PubMed

Lucky, A W; Biro, F M; Huster, G A; Morrison, J A; Elder, N

1991-02-01

To assess the prevalence and severity of acne vulgaris in young adolescent boys, we studied 219 black and 249 white boys in fifth through ninth grades in Cincinnati, Ohio. The mean age was 12.2 +/- 1.4 years, with a range of 9 to 15 years. Pubertal maturation was scored as Tanner pubic hair stages (PH I to V) and pubertal stages (PS I to IV) that included testicular volume assessment. Acne was scored by number of comedonal (open plus closed comedones) and inflammatory (papules plus pustules) lesions. Comedonal and inflammatory lesions were analyzed separately and evaluated both as numerical scores and as grades (1, less than or equal to 10 lesions; 2, 11 to 25 lesions; and 3, greater than or equal to 26 lesions). Grades 2 and 3 were considered clinically significant acne. Acne became progressively more severe with advancing maturity. Mean acne scores correlated better with PS and pubic hair than with age. Black subjects were more mature than white subjects. Black boys in PSI and II had significantly more comedones than white boys; white boys had significantly more inflammatory lesions at PS I and III. Clinically significant comedonal acne was already present in PS I and occurred in 100% of boys in PS IV. In contrast, no boys at PS I and only 50% at PS IV had significant inflammatory acne. Midfacial acne dominated. We concluded that acne prevalence and severity correlate well with advancing pubertal maturation in young adolescent boys. Comedonal acne was more frequent and severe than inflammatory disease. Awareness of the extent and severity of acne in preadolescents and young adolescents may ultimately provide rationale for early intervention and thus prevention of severe acne vulgaris.

Unsupervised online classifier in sleep scoring for sleep deprivation studies.

PubMed

Libourel, Paul-Antoine; Corneyllie, Alexandra; Luppi, Pierre-Hervé; Chouvet, Guy; Gervasoni, Damien

2015-05-01

This study was designed to evaluate an unsupervised adaptive algorithm for real-time detection of sleep and wake states in rodents. We designed a Bayesian classifier that automatically extracts electroencephalogram (EEG) and electromyogram (EMG) features and categorizes non-overlapping 5-s epochs into one of the three major sleep and wake states without any human supervision. This sleep-scoring algorithm is coupled online with a new device to perform selective paradoxical sleep deprivation (PSD). Controlled laboratory settings for chronic polygraphic sleep recordings and selective PSD. Ten adult Sprague-Dawley rats instrumented for chronic polysomnographic recordings. The performance of the algorithm is evaluated by comparison with the score obtained by a human expert reader. Online detection of PS is then validated with a PSD protocol with duration of 72 hours. Our algorithm gave a high concordance with human scoring with an average κ coefficient > 70%. Notably, the specificity to detect PS reached 92%. Selective PSD using real-time detection of PS strongly reduced PS amounts, leaving only brief PS bouts necessary for the detection of PS in EEG and EMG signals (4.7 ± 0.7% over 72 h, versus 8.9 ± 0.5% in baseline), and was followed by a significant PS rebound (23.3 ± 3.3% over 150 minutes). Our fully unsupervised data-driven algorithm overcomes some limitations of the other automated methods such as the selection of representative descriptors or threshold settings. When used online and coupled with our sleep deprivation device, it represents a better option for selective PSD than other methods like the tedious gentle handling or the platform method. © 2015 Associated Professional Sleep Societies, LLC.

Real-life clinical practice results with vinflunine in patients with relapsed platinum-treated metastatic urothelial carcinoma: an Italian multicenter study (MOVIE-GOIRC 01-2014).

PubMed

Passalacqua, Rodolfo; Lazzarelli, Silvia; Donini, Maddalena; Montironi, Rodolfo; Tambaro, Rosa; De Giorgi, Ugo; Pignata, Sandro; Palumbo, Raffaella; Ceresoli, Giovanni Luca; Del Conte, Gianluca; Tonini, Giuseppe; Morelli, Franco; Nolè, Franco; Panni, Stefano; Rondini, Ermanno; Guida, Annalisa; Zucali, Paolo Andrea; Doni, Laura; Iezzi, Elisa; Caminiti, Caterina

2017-07-19

Vinflunine is the only chemotherapeutic agent shown to improve survival in platinum-refractory patients with metastatic transitional cell carcinoma of the urothelium (TCCU) in a phase III clinical trial, which led to product registration for this indication in Europe. The aim of this study was to assess the efficacy of vinflunine and to evaluate the prognostic significance of risk factors in a large, unselected cohort of patients with metastatic TCCU treated according to routine clinical practice. This was a retrospective multicenter study. Italian cancer centers were selected if, according to the Registry of the Italian Medicines Agency (AIFA), at least four patients had been treated with vinflunine between February 2011 and June 2014, after first- or second-line platinum-based chemotherapy. The primary objective was to test whether the efficacy measured by overall survival (OS) in the registration study could be confirmed in routine clinical practice. Multivariate analysis was carried out using Cox proportional hazard model. A total of 217 patients were treated in 28 Italian centers. Median age was 69 years (IQR 62-76) and 84% were male; Eastern Cooperative Oncology Group performance status (ECOG PS) was ≥ 1 in 53% of patients. The median number of cycles was 4 (IQR 2-6); 29%, 35%, and 36% received an initial dose of 320 mg/m 2 , 280 mg/m 2 or a lower dose, respectively. Median progression-free survival (PFS) and OS for the entire population was 3.2 months (2.6-3.7) and 8.1 months (6.3-8.9). A complete response was observed in six patients, partial response in 21, stable disease in 60, progressive disease in 108, with a disease control rate of 40%. Multivariate analysis showed that ECOG PS, number of metastatic sites and liver involvement were unfavorable prognostic factors for OS. Toxicity was mild, and grade 3-4 adverse effects were mainly: neutropenia (9%), anemia (6%), asthenia/fatigue (7%) and constipation (5%). In routine clinical practice the results obtained with VFL seem to be better than the results of the registration trial and reinforce evidence supporting its use after failure of a platinum-based chemotherapy.

A multicenter survey of first-line treatment patterns and gene aberration test status of patients with unresectable Stage IIIB/IV nonsquamous non-small cell lung cancer in China (CTONG 1506).

PubMed

Zhou, Qing; Song, Yong; Zhang, Xin; Chen, Gong-Yan; Zhong, Dian-Sheng; Yu, Zhuang; Yu, Ping; Zhang, Yi-Ping; Chen, Jian-Hua; Hu, Yi; Feng, Guo-Sheng; Song, Xia; Shi, Qiang; Yang, Lu Lu; Zhang, Ping Hai; Wu, Yi-Long

2017-07-03

In recent years, systemic chemotherapy and molecular targeted therapy have become standard first-line treatments for locally advanced or metastatic nonsquamous non-small cell lung cancer (NSCLC). The objective of this survey was to investigate first-line anticancer treatment patterns and gene aberration test status of patients with advanced nonsquamous NSCLC in China. Patients included in this study had unresectable Stage IIIB/IV nonsquamous NSCLC and were admitted during August 2015 to March 2016 into one of 12 tertiary hospitals throughout China for first-line anticancer treatment. Patient data (demographics, NSCLC histologic type, Eastern Cooperative Oncology Group [ECOG] Performance Status [PS], gene aberration test and results [if performed], and first-line anticancer treatment regimen) were extracted from medical charts and entered into Medical Record Abstraction Forms (MERAFs), which were collated for analysis. Overall, 1041 MERAFs were collected and data from 932 MERAFs were included for analysis. Patients with unresectable Stage IIIB/IV nonsquamous NSCLC had a median age of 59 years, 56.4% were male, 58.2% were never smokers, 95.0% had adenocarcinoma, and 92.9% had an ECOG PS ≤1. A total of 665 (71.4%) patients had gene aberration tests; 46.5% (309/665) had epidermal growth factor receptor (EGFR) gene mutations, 11.5% (48/416) had anaplastic lymphoma kinase (ALK) gene fusions, and 0.8% (1/128) had a c-ros oncogene 1 gene fusion. The most common first-line treatment regimen for unresectable Stage IIIB/IV nonsquamous NSCLC was chemotherapy (72.5%, 676/932), followed by tyrosine kinase inhibitors (TKIs; 26.1%, 243/932), and TKIs plus chemotherapy (1.4%, 13/932). Most chemotherapy regimens were platinum-doublet regimens (93.5%, 631/676) and pemetrexed was the most common nonplatinum chemotherapy-backbone agent (70.2%, 443/631) in platinum-doublet regimens. Most EGFR mutation-positive patients (66.3%, 205/309) were treated with EGFR-TKIs. Findings from our survey of 12 tertiary hospitals throughout China showed an increased rate of gene aberration testing, compared with those rates reported in previous surveys, for patients with advanced nonsquamous NSCLC. In addition, pemetrexed/platinum-doublet chemotherapy was the predominant first-line chemotherapy regimen for this population. Most patients were treated based on their gene aberration test status and results.

Trifluridine/Tipiracil (TAS-102) in Refractory Metastatic Colorectal Cancer: A Multicenter Register in the Frame of the Italian Compassionate Use Program.

PubMed

Cremolini, Chiara; Rossini, Daniele; Martinelli, Erika; Pietrantonio, Filippo; Lonardi, Sara; Noventa, Silvia; Tamburini, Emiliano; Frassineti, Giovanni Luca; Mosconi, Stefania; Nichetti, Federico; Murgioni, Sabina; Troiani, Teresa; Borelli, Beatrice; Zucchelli, Gemma; Dal Maso, Alessandro; Sforza, Vincenzo; Masi, Gianluca; Antoniotti, Carlotta; Di Bartolomeo, Maria; Miceli, Rosalba; Ciardiello, Fortunato; Falcone, Alfredo

2018-05-08

TAS-102 is indicated for patients with metastatic colorectal cancer (mCRC) previously treated with, or not considered candidates for, available therapies. Given the complete inefficacy in half of patients, the lack of predictive factors, the palliative setting, and the financial and clinical toxicity, optimizing the cost-benefit ratio is crucial. The "ColonLife" nomogram allows an estimate of the 12-week life expectancy of patients with refractory mCRC. We collected data from patients treated at eight Italian centers in the compassionate use program. Baseline characteristics of patients who were or were not progression free at 6 months were compared. The discriminative ability of the ColonLife nomogram was assessed. Among patients who received both TAS-102 and regorafenib, clinical outcomes of the two sequences were compared. This study included 341 patients. Six (2%) and 93 (27%) patients achieved response and disease stabilization, respectively. The median progression-free survival (PFS) was 2.4 months with an estimated 6-month PFS rate of 19%; the median overall survival (OS) was 6.2 months. An Eastern Cooperative Oncology Group performance status (ECOG PS) of 0, normal lactate dehydrogenase (LDH), and a time from the diagnosis of metastatic disease of >18 months were independently associated with higher chances of a patient being progression free at 6 months. The discriminative ability of ColonLife was confirmed. Among 121 patients who received both regorafenib and TAS-102, no differences in first or second PFS or OS were reported between the two sequences. One out of five patients achieves clinical benefit with TAS-102. ECOG PS, LDH, and time from diagnosis of metastatic disease may help to identify these patients. Excluding patients with very short life expectancy appears a reasonable approach. Improving the cost-efficacy ratio of TAS-102 in metastatic colorectal cancer is needed to spare useless toxicities in a definitely palliative setting. Eastern Cooperative Oncology Group performance status, lactate dehydrogenase levels, and time from the diagnosis of metastatic disease may help to identify patients more likely to achieve benefit. Properly designed prognostic tools (i.e., the "ColonLife" nomogram) may enable excluding from further treatments patients with very limited life expectancy. © AlphaMed Press 2018.

Adjuvant Sunitinib for High-risk Renal Cell Carcinoma After Nephrectomy: Subgroup Analyses and Updated Overall Survival Results.

PubMed

Motzer, Robert J; Ravaud, Alain; Patard, Jean-Jacques; Pandha, Hardev S; George, Daniel J; Patel, Anup; Chang, Yen-Hwa; Escudier, Bernard; Donskov, Frede; Magheli, Ahmed; Carteni, Giacomo; Laguerre, Brigitte; Tomczak, Piotr; Breza, Jan; Gerletti, Paola; Lechuga, Mariajose; Lin, Xun; Casey, Michelle; Serfass, Lucile; Pantuck, Allan J; Staehler, Michael

2018-01-01

Adjuvant sunitinib significantly improved disease-free survival (DFS) versus placebo in patients with locoregional renal cell carcinoma (RCC) at high risk of recurrence after nephrectomy (hazard ratio [HR] 0.76, 95% confidence interval [CI] 0.59-0.98; p=0.03). To report the relationship between baseline factors and DFS, pattern of recurrence, and updated overall survival (OS). Data for 615 patients randomized to sunitinib (n=309) or placebo (n=306) in the S-TRAC trial. Subgroup DFS analyses by baseline risk factors were conducted using a Cox proportional hazards model. Baseline risk factors included: modified University of California Los Angeles integrated staging system criteria, age, gender, Eastern Cooperative Oncology Group performance status (ECOG PS), weight, neutrophil-to-lymphocyte ratio (NLR), and Fuhrman grade. Of 615 patients, 97 and 122 in the sunitinib and placebo arms developed metastatic disease, with the most common sites of distant recurrence being lung (40 and 49), lymph node (21 and 26), and liver (11 and 14), respectively. A benefit of adjuvant sunitinib over placebo was observed across subgroups, including: higher risk (T3, no or undetermined nodal involvement, Fuhrman grade ≥2, ECOG PS ≥1, T4 and/or nodal involvement; hazard ratio [HR] 0.74, 95% confidence interval [CI] 0.55-0.99; p=0.04), NLR ≤3 (HR 0.72, 95% CI 0.54-0.95; p=0.02), and Fuhrman grade 3/4 (HR 0.73, 95% CI 0.55-0.98; p=0.04). All subgroup analyses were exploratory, and no adjustments for multiplicity were made. Median OS was not reached in either arm (HR 0.92, 95% CI 0.66-1.28; p=0.6); 67 and 74 patients died in the sunitinib and placebo arms, respectively. A benefit of adjuvant sunitinib over placebo was observed across subgroups. The results are consistent with the primary analysis, which showed a benefit for adjuvant sunitinib in patients at high risk of recurrent RCC after nephrectomy. Most subgroups of patients at high risk of recurrent renal cell carcinoma after nephrectomy experienced a clinical benefit with adjuvant sunitinib. ClinicalTrials.gov NCT00375674. Copyright © 2017 European Association of Urology. Published by Elsevier B.V. All rights reserved.

Esophageal stenosis and the Glasgow Prognostic Score as independent factors of poor prognosis for patients with locally advanced unresectable esophageal cancer treated with chemoradiotherapy (exploratory analysis of JCOG0303).

PubMed

Okuno, Tatsuya; Wakabayashi, Masashi; Kato, Ken; Shinoda, Masayuki; Katayama, Hiroshi; Igaki, Hiroyasu; Tsubosa, Yasuhiro; Kojima, Takashi; Okabe, Hiroshi; Kimura, Yusuke; Kawano, Tatsuyuki; Kosugi, Shinichi; Toh, Yasushi; Kato, Hoichi; Nakamura, Kenichi; Fukuda, Haruhiko; Ishikura, Satoshi; Ando, Nobutoshi; Kitagawa, Yuko

2017-12-01

The aim of this study was to investigate the possible prognostic factors and predictive accuracy of the Glasgow Prognostic Score (GPS) for patients with unresectable locally advanced esophageal squamous cell carcinoma (LAESCC) treated with chemoradiotherapy. One hundred forty-two patients were enrolled in JCOG0303 and assigned to the standard cisplatin and 5-fluorouracil (PF)-radiotherapy (RT) group or the low-dose PF-RT group. One hundred thirty-one patients with sufficient data were included in this analysis. A Cox regression model was used to analyze the prognostic factors of patients with unresectable LAESCC treated with PF-RT. The GPS was classified based on the baseline C-reactive protein (CRP) and serum albumin levels. Patients with CRP ≤1.0 mg/dL and albumin ≥3.5 g/dL were classified as GPS0. If only CRP was increased or only albumin was decreased, the patients were classified as GPS1, and the patients with CRP >1.0 mg/dL and albumin <3.5 g/dL were classified as GPS2. The patients' backgrounds were as follows: median age (range), 62 (37-75); male/female, 119/12; ECOG PS 0/1/2, 64/65/2; and clinical stage (UICC 5th) IIB/III/IVA/IVB, 3/75/22/31. Multivariable analyses indicated only esophageal stenosis as a common factor for poor prognosis. In addition, overall survival tended to decrease according to the GPS subgroups (median survival time (months): GPS0/GPS1/GPS2 16.1/14.9/8.7). Esophageal stenosis was identified as a candidate stratification factor for randomized trials of unresectable LAESCC patients. Furthermore, GPS represents a prognostic factor for LAESCC patients treated with chemoradiotherapy. UMIN000000861.

High gamma power in ECoG reflects cortical electrical stimulation effects on unit activity in layers V/VI

NASA Astrophysics Data System (ADS)

Yazdan-Shahmorad, Azadeh; Kipke, Daryl R.; Lehmkuhle, Mark J.

2013-12-01

Objective. Cortical electrical stimulation (CES) has been used extensively in experimental neuroscience to modulate neuronal or behavioral activity, which has led this technique to be considered in neurorehabilitation. Because the cortex and the surrounding anatomy have irregular geometries as well as inhomogeneous and anisotropic electrical properties, the mechanism by which CES has therapeutic effects is poorly understood. Therapeutic effects of CES can be improved by optimizing the stimulation parameters based on the effects of various stimulation parameters on target brain regions. Approach. In this study we have compared the effects of CES pulse polarity, frequency, and amplitude on unit activity recorded from rat primary motor cortex with the effects on the corresponding local field potentials (LFP), and electrocorticograms (ECoG). CES was applied at the surface of the cortex and the unit activity and LFPs were recorded using a penetrating electrode array, which was implanted below the stimulation site. ECoGs were recorded from the vicinity of the stimulation site. Main results. Time-frequency analysis of LFPs following CES showed correlation of gamma frequencies with unit activity response in all layers. More importantly, high gamma power of ECoG signals only correlated with the unit activity in lower layers (V-VI) following CES. Time-frequency correlations, which were found between LFPs, ECoGs and unit activity, were frequency- and amplitude-dependent. Significance. The signature of the neural activity observed in LFP and ECoG signals provides a better understanding of the effects of stimulation on network activity, representative of large numbers of neurons responding to stimulation. These results demonstrate that the neurorehabilitation and neuroprosthetic applications of CES targeting layered cortex can be further improved by using field potential recordings as surrogates to unit activity aimed at optimizing stimulation efficacy. Likewise, the signatures of unit activity observed as changes in high gamma power in ECoGs suggest that future cortical stimulation studies could rely on less invasive feedback schemes that incorporate surface stimulation with ECoG reporting of stimulation efficacy.

A propensity score approach to correction for bias due to population stratification using genetic and non-genetic factors.

PubMed

Zhao, Huaqing; Rebbeck, Timothy R; Mitra, Nandita

2009-12-01

Confounding due to population stratification (PS) arises when differences in both allele and disease frequencies exist in a population of mixed racial/ethnic subpopulations. Genomic control, structured association, principal components analysis (PCA), and multidimensional scaling (MDS) approaches have been proposed to address this bias using genetic markers. However, confounding due to PS can also be due to non-genetic factors. Propensity scores are widely used to address confounding in observational studies but have not been adapted to deal with PS in genetic association studies. We propose a genomic propensity score (GPS) approach to correct for bias due to PS that considers both genetic and non-genetic factors. We compare the GPS method with PCA and MDS using simulation studies. Our results show that GPS can adequately adjust and consistently correct for bias due to PS. Under no/mild, moderate, and severe PS, GPS yielded estimated with bias close to 0 (mean=-0.0044, standard error=0.0087). Under moderate or severe PS, the GPS method consistently outperforms the PCA method in terms of bias, coverage probability (CP), and type I error. Under moderate PS, the GPS method consistently outperforms the MDS method in terms of CP. PCA maintains relatively high power compared to both MDS and GPS methods under the simulated situations. GPS and MDS are comparable in terms of statistical properties such as bias, type I error, and power. The GPS method provides a novel and robust tool for obtaining less-biased estimates of genetic associations that can consider both genetic and non-genetic factors. 2009 Wiley-Liss, Inc.

Hyperammonemia in Urinary Tract Infections.

PubMed

Kenzaka, Tsuneaki; Kato, Ken; Kitao, Akihito; Kosami, Koki; Minami, Kensuke; Yahata, Shinsuke; Fukui, Miho; Okayama, Masanobu

2015-01-01

The present study investigated the incidence of hyperammonemia in urinary tract infections and explored the utility of urinary obstruction relief and antimicrobial administration to improve hyperammonemia. This was an observational study. Subjects were patients who were diagnosed with urinary tract infection and hospitalized between June 2008 and June 2009. We measured plasma ammonia levels on admission in patients who were clinically diagnosed with urinary tract infection and hospitalized. We assessed each patient's level of consciousness on admission using the Glasgow Coma Scale (GCS) and performed urine and blood cultures. We also assessed hearing prior to hospitalization using the Eastern Cooperative Oncology Group performance status (ECOG-PS). In cases with high ammonia levels on admission, plasma ammonia and GCS were measured 24 hours and 5-7 days later. Sixty-seven candidates were enrolled; of these, 60 cases (89.6%) with bacterial cell counts ≥10(4) CFU/mL were studied. Five cases (8.3%) presented with high plasma ammonia levels. Cases with hyperammonemia were significantly more likely to present with low GCS scores and urinary retention rate. All five cases received antimicrobial therapy with an indwelling bladder catheter to relieve urinary retention. The case 5 patient died shortly after admission due to complicated aspiration pneumonia; in the remaining cases, plasma ammonia levels were rapidly normalized and the level of consciousness improved. The occurrence of hyperammonemia in urinary tract infections is not rare. The cause of hyperammonemia is urinary retention obstruction. Therefore, along with antimicrobial administration, relief of obstruction is important for the treatment of hyperammonemia caused by this mechanism.

Comparison between Antiemetic Effects of Palonosetron and Granisetron on Chemotherapy-Induced Nausea and Vomiting in Japanese Patients Treated with R-CHOP.

PubMed

Uchida, Mayako; Mori, Yasuo; Nakamura, Tsutomu; Kato, Koji; Kamezaki, Kenjiro; Takenaka, Katsuto; Shiratsuchi, Motoaki; Kadoyama, Kaori; Miyamoto, Toshihiro; Akashi, Koichi

2017-01-01

In the present study, the antiemetic effect of palonosetron, not combined with dexamethasone and aprepitant, on chemotherapy-induced nausea and vomiting was evaluated in patients with malignant lymphoma receiving first-line rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) therapy, and was compared to that of granisetron. A total of 74 patients with non-Hodgkin lymphoma were included in this study (April 2007 to December 2015). Palonosetron (0.75 mg) or granisetron (3 mg) was intravenously administered before R-CHOP therapy. The proportions of patients with complete response (CR) during the overall (0-120 h after the start of R-CHOP therapy), acute (0-24 h) and delayed (24-120 h) phases were evaluated. CR was defined as no vomiting and no use of antiemetic rescue medication. A total of 32 and 42 patients were treated with palonosetron and granisetron, respectively. The CR rate in the palonosetron group was significantly higher than that in the granisetron group during the delayed phase (90.6 and 61.9%, respectively; p=0.007). Logistic regression analysis showed that use of palonosetron improved the CR rate during the delayed phase, compared to use of granisetron. Female sex, age less than 60 years, no habitual alcohol intake, and Eastern Cooperative Oncology Group performance status (ECOG-PS) score of 1 were significant risk factors associated with non-CR. The findings of this study suggested the superiority of palonosetron to granisetron, without accompanying dexamethasone and aprepitant, for chemotherapy-induced nausea and vomiting in patients with malignant lymphoma.

[La combinazione di gemcitabina e oxaliplatino (GEMOX) nel trattamento del carcinoma pancreatico in fase avanzata di malattia: le notizie sulla mia morte sono state esagerate?

PubMed

Giuliani, Jacopo; Bonetti, Andrea

2017-12-01

Riassunto. L'analisi è stata condotta al fine di valutare l'effetto sia sulla sopravvivenza globale (OS) sia sulla sopravvivenza libera da progressione di malattia (PFS) della chemioterapia di combinazione in prima linea per il carcinoma pancreatico in fase avanzata di malattia. La presente analisi è limitata agli studi randomizzati controllati (RCT) di fase III. Successivamente è stata applicata la European Society for Medical Oncology Magnitude of Clinical Benefit Scale (ESMO-MCBS) agli RCT di fase III analizzati per ricavare uno score relativo all'entità del beneficio clinico ottenuto per ciascun RCT. Sono state calcolate inoltre le differenze in termini di PFS tra i diversi bracci di trattamento rapportandole con i costi dei farmaci necessari per ottenere il beneficio di PFS. La nostra analisi ha valutato 11 RCT di fase III, per un totale di 4572 pazienti. Combinando i costi della terapia con la misura dell'efficacia espressa dalla PFS, è stato ottenuto un costo di 74,12 euro (€) per mese di vita guadagnato in termini di PFS con la combinazione di 5-fluorouracil, leucovorin, irinotecan e oxaliplatino (FOLFIRINOX), 90,14 € per la combinazione di gemcitabina e oxaliplatino (GEMOX) e 4708,7 € per la combinazione di nab-paclitaxel e gemcitabina. Da questo punto di vista riteniamo che l'utilizzo delle "vecche chemioterapie di combinazione" (per es., GEMOX) non dovrebbe essere completamente abbandonato, ma valutato sul singolo paziente, sulla base di diversi fattori (età, ECOG PS, comorbilità, carico di malattia), al fine di ottenere una reale "tailored therapy".

Photosystem II functionality and antioxidant system changes during leaf rolling in post-stress emerging Ctenanthe setosa exposed to drought.

PubMed

Terzi, Rabiye; Saruhan, Neslihan; Sağlam, A; Nar, Hatice; Kadioğlu, A

2009-12-01

We studied the changes in antioxidant system and chlorophyll fluorescence parameters in post-stress emerging Ctenanthe setosa (Rosc.) Eichler (Marantaceae) plants (PSE plants) having reduced leaf area under drought stress causing leaf rolling and re-watering. PSE plants were compared to primary stressed plants (PS) in previous studies. The parameters were measured at different visual leaf rolling scores from 1 to 4 (1 is unrolled, 4 is tightly rolled and the others is intermediate form). Water potentials and stomatal conductance of leaves were gradually decreased during leaf rolling. Similarly, maximum quantum efficiency of open PS II center and quantum yield of PS II decreased during the rolling period. Non-photochemical quenching of chlorophyll fluorescence decreased at score 2 then increased while photochemical quenching did not change during leaf rolling. Electron transport rate decreased only at score 4 but approximately reached to score 1 level after re-watering. Superoxide dismutase activity was not constant at all leaf rolling scores. Ascorbate peroxidase, catalase and glutathione reductase activities generally tended to increase during leaf rolling. Lipid peroxidation and H 2 O 2 content increased at score 2 but decreased at the later scores. On the other hand, O 2 .- production increased during the rolling period. After re-watering of the plants having score 4 of leaf rolling, antioxidant enzyme activities were lower than those of score 1. Other physiological parameters also tended to reach the value of score 1. The results indicated that PSE plants gained drought tolerance by reducing leaf area effectively induced their antioxidant systems and protected the photosynthesis under drought stress similar to PS plants.

Propensity Score Techniques and the Assessment of Measured Covariate Balance to Test Causal Associations in Psychological Research

ERIC Educational Resources Information Center

Harder, Valerie S.; Stuart, Elizabeth A.; Anthony, James C.

2010-01-01

There is considerable interest in using propensity score (PS) statistical techniques to address questions of causal inference in psychological research. Many PS techniques exist, yet few guidelines are available to aid applied researchers in their understanding, use, and evaluation. In this study, the authors give an overview of available…

Prognostic Role of Pre–Radiation Therapy {sup 18}F-Fluorodeoxyglucose Positron Emission Tomography for Primary Mediastinal B-Cell Lymphomas Treated with R-CHOP or R-CHOP-Like Chemotherapy Plus Radiation

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

Filippi, Andrea Riccardo, E-mail: andreariccardo.filippi@unito.it; Piva, Cristina; Levis, Mario

Purpose: To validate, in a monoinstitutional cohort with extended follow-up, that post–rituximab chemotherapy (R-CT) {sup 18}F-fluorodeoxyglucose positron emission tomography ({sup 18}FDG-PET) is a prognostic factor allowing discrimination of primary mediastinal B-cell lymphoma (PMBCL) patients at higher risk for progression after radiation therapy. Methods and Materials: We analyzed 51 patients, and {sup 18}FDG-PET scans were re-examined evaluating both the Deauville 5-point scale (D5PS) score and the standardized uptake value (SUV) of residual activity, if present. These parameters were then tested by univariate analysis for a potential correlation with progression-free survival (PFS) as the primary study endpoint. Results: Median follow-up time was 51 monthsmore » (range, 9-153 months). After R-CT, D5PS score was 1 in 10 (19.6%), 2 in 11 (21.6%), 3 in 7 (13.8%), 4 in 17 (33.3%), and 5 in 6 patients (11.7%). Forty-three out of 51 patients (84.3%) had an SUV{sub max} ≤5, and 8 out of 51 (15.7%) had an SUV{sub max} ≥5. Overall, 6 patients experienced progression or relapse: 1 had a D5PS score 2 (with SUV{sub max} ≤5), and 5 had a D5PS score 5 (and SUV{sub max} ≥5). Patients with a D5PS score 5 showed significantly lower PFS rates versus all other scores (log-rank P<.001), as did patients with SUV{sub max} ≥5 when compared with those with SUV{sub max} ≤5 (log-rank P<.001). Conclusions: The present study confirmed the prognostic role of {sup 18}FDG-PET after R-CT, with patients with a D5PS score of 5 and/or an SUV{sub max} ≥5 being at high risk of progression/relapse after RT.« less

[Impact of hypoxia in different periods of prenatal ontogenesis on ECoG of rabbit fetus].

PubMed

Guseĭnov, A G; Mamedov, Kh B

2012-10-01

Sensitivity of ECoG of sensorimotor cortex of 28-day rabbit foetus in different periods (prefetal and fetal) of embryogenesis to hypoxia impact was studied. In the foetus subjected to hypoxia during prefetal period (8-18th days) in the spectrum of the general activity the increase of slow waves, occupying little portion of the spectrum, is noticed, while the main delta-rhythm has more clear pattern. At the same time, hypoxia, undertaken in the fetal period (18-28th days) does not have significant effect on ECoG indexes. On the basis of our own and literature data one can propose tha high sensitivity of ECoG to oxygen deficiency is due to low stability of the brain cortex itself and subcortical white matter to hypoxic inpairement in early embriogenesis.

Behavioral states may be associated with distinct spatial patterns in electrocorticogram.

PubMed

Panagiotides, Heracles; Freeman, Walter J; Holmes, Mark D; Pantazis, Dimitrios

2011-03-01

To determine if behavioral states are associated with unique spatial electrocorticographic (ECoG) patterns, we obtained recordings with a microgrid electrode array applied to the cortical surface of a human subject. The array was constructed with the intent of extracting maximal spatial information by optimizing interelectrode distances. A 34-year-old patient with intractable epilepsy underwent intracranial ECoG monitoring after standard methods failed to reveal localization of seizures. During the 8-day period of invasive recording, in addition to standard clinical electrodes a square 1 × 1 cm microgrid array with 64 electrodes (1.25 mm separation) was placed on the right inferior temporal gyrus. Careful review of video recordings identified four extended naturalistic behaviors: reading, conversing on the telephone, looking at photographs, and face-to-face interactions. ECoG activity recorded with the microgrid that corresponded to these behaviors was collected and ECoG spatial patterns were analyzed. During periods of ECoG selected for analysis, no electrographic seizures or epileptiform patterns were present. Moments of maximal spatial variance are shown to cluster by behavior. Comparisons between conditions using a permutation test reveal significantly different spatial patterns for each behavior. We conclude that ECoG recordings obtained on the cortical surface with optimal high spatial frequency resolution reveal distinct local spatial patterns that reflect different behavioral states, and we predict that similar patterns will be found in many if not most cortical areas on which a microgrid is placed.

Multimodality language mapping in patients with left-hemispheric language dominance on Wada test

PubMed Central

Kojima, Katsuaki; Brown, Erik C.; Rothermel, Robert; Carlson, Alanna; Matsuzaki, Naoyuki; Shah, Aashit; Atkinson, Marie; Mittal, Sandeep; Fuerst, Darren; Sood, Sandeep; Asano, Eishi

2012-01-01

Objective We determined the utility of electrocorticography (ECoG) and stimulation for detecting language-related sites in patients with left-hemispheric language-dominance on Wada test. Methods We studied 13 epileptic patients who underwent language mapping using event-related gamma-oscillations on ECoG and stimulation via subdural electrodes. Sites showing significant gamma-augmentation during an auditory-naming task were defined as language-related ECoG sites. Sites at which stimulation resulted in auditory perceptual changes, failure to verbalize a correct answer, or sensorimotor symptoms involving the mouth were defined as language-related stimulation sites. We determined how frequently these methods revealed language-related sites in the superior-temporal, inferior-frontal, dorsolateral-premotor, and inferior-Rolandic regions. Results Language-related sites in the superior-temporal and inferior-frontal gyri were detected by ECoG more frequently than stimulation (p < 0.05), while those in the dorsolateral-premotor and inferior-Rolandic regions were detected by both methods equally. Stimulation of language-related ECoG sites, compared to the others, more frequently elicited language symptoms (p < 0.00001). One patient developed dysphasia requiring in-patient speech therapy following resection of the dorsolateral-premotor and inferior-Rolandic regions containing language-related ECoG sites not otherwise detected by stimulation. Conclusions Language-related gamma-oscillations may serve as an alternative biomarker of underlying language function in patients with left-hemispheric language-dominance. Significance Measurement of language-related gamma-oscillations is warranted in presurgical evaluation of epileptic patients. PMID:22503906

The influence of personality type on decision making in the physical therapy admission process.

PubMed

Bezner, J R; Boucher, B K

2001-01-01

The purpose of this study was to identify the personality types of physical therapy (PT) interviewers and applicants, using the Personality Styles (PS) assessment tool, and to determine whether an interview team's personality type influences the rating score given. The PS was validated in a study of 298 students who completed the Myers-Briggs Type Indicator (MBTI) Form G and a PS assessment. By chi-square analysis the PS model appears to be a valid representation of the MBTI (chi 2 = 86.62, p < 0.00001). Subjects for the interview portion of the study were 282 student applicants, 19 faculty, and 47 clinicians from two PT programs. A randomly assigned faculty/clinician team interviewed each applicant. Two one-way ANOVAs were performed with interview score as the dependent variable and 1) applicant personality type in relation to faculty/clinician team (same, different from both, like one) and 2) applicant personality type as the independent variables. Internal consistency of the interview rating form was alpha = 0.89. Mean interview score was 33.97/42 (SD 4.59). Interview scores were not significantly different between applicants who interviewed with clinician/faculty teams that were "like" compared with "not like" the applicants (F0.864; p = 0.423), but were significantly different between applicants with different PS personality types (F3.159; p = 0.026). Although personality type of the interview team did not impact the score given, thereby refuting the presence of interviewer bias, the rating scores did vary according to personality type of the applicant, suggesting a possible stereotyping bias in the criteria used to rate applicants.

Posterior Cruciate Ligament Retention versus Posterior Stabilization for Total Knee Arthroplasty: A Meta-Analysis.

PubMed

Jiang, Chao; Liu, Zhenlei; Wang, Ying; Bian, Yanyan; Feng, Bin; Weng, Xisheng

2016-01-01

Although being debated for many years, the superiority of posterior cruciate-retaining (CR) total knee arthroplasty (TKA) and posterior-stabilized (PS) TKA remains controversial. We compare the knee scores, post-operative knee range of motion (ROM), radiological outcomes about knee kinematic and complications between CR TKA and PS TKA. Literature published up to August 2015 was searched in PubMed, Embase and Cochrane databases, and meta-analysis was performed using the software, Review Manager version 5.3. Totally 14 random control trials (RCTs) on this topic were included for the analysis, which showed that PS and CR TKA had no significant difference in Knee Society knee Score (KSS), pain score (KSPS), Hospital for Special Surgery score (HSS), kinematic characteristics including postoperative component alignment, tibial posterior slope and joint line, and complication rate. However, PS TKA is superior to CR TKA regarding post-operative knee range of motion (ROM) [Random Effect model (RE), Mean Difference (MD) = -7.07, 95% Confidential Interval (CI) -10.50 to -3.65, p<0.0001], improvement of ROM (Fixed Effect model (FE), MD = -5.66, 95% CI -10.79 to -0.53, p = 0.03) and femoral-tibial angle [FE, MD = 0.85, 95% CI 0.46 to 1.25, p<0.0001]. There are no clinically relevant differences between CR and PS TKA in terms of clinical, functional, radiological outcome, and complications, while PS TKA is superior to CR TKA in respects of ROM, while whether this superiority matters or not in clinical practice still needs further investigation and longer follow-up.

Intrauterine Exposure to Methylmercury and Neurocognitive Functions: Minamata Disease.

PubMed

Yorifuji, Takashi; Kato, Tsuguhiko; Kado, Yoko; Tokinobu, Akiko; Yamakawa, Michiyo; Tsuda, Toshihide; Sanada, Satoshi

2015-01-01

A large-scale food poisoning caused by methylmercury was identified in Minamata, Japan, in the 1950s. The severe intrauterine exposure cases are well known, although the possible impact of low-to-moderate methylmercury exposure in utero are rarely investigated. We examined neurocognitive functions among 22 participants in Minamata, mainly using an intelligence quotient test (Wechsler Adults Intelligent Scale III), in 2012/2013. The participants tended to score low on the Index score of processing speed (PS) relative to full-scale IQ, and discrepancies between PS and other scores within each participant were observed. The lower score on PS was due to deficits in digit symbol-coding and symbol search and was associated with methylmercury concentration in umbilical cords. The residents who experienced low-to-moderate methylmercury exposure including prenatal one in Minamata manifested deficits in their cognitive functions, processing speed in particular.

On the use and misuse of scalar scores of confounders in design and analysis of observational studies.

PubMed

Pfeiffer, R M; Riedl, R

2015-08-15

We assess the asymptotic bias of estimates of exposure effects conditional on covariates when summary scores of confounders, instead of the confounders themselves, are used to analyze observational data. First, we study regression models for cohort data that are adjusted for summary scores. Second, we derive the asymptotic bias for case-control studies when cases and controls are matched on a summary score, and then analyzed either using conditional logistic regression or by unconditional logistic regression adjusted for the summary score. Two scores, the propensity score (PS) and the disease risk score (DRS) are studied in detail. For cohort analysis, when regression models are adjusted for the PS, the estimated conditional treatment effect is unbiased only for linear models, or at the null for non-linear models. Adjustment of cohort data for DRS yields unbiased estimates only for linear regression; all other estimates of exposure effects are biased. Matching cases and controls on DRS and analyzing them using conditional logistic regression yields unbiased estimates of exposure effect, whereas adjusting for the DRS in unconditional logistic regression yields biased estimates, even under the null hypothesis of no association. Matching cases and controls on the PS yield unbiased estimates only under the null for both conditional and unconditional logistic regression, adjusted for the PS. We study the bias for various confounding scenarios and compare our asymptotic results with those from simulations with limited sample sizes. To create realistic correlations among multiple confounders, we also based simulations on a real dataset. Copyright © 2015 John Wiley & Sons, Ltd.

Histological Evaluation of a Chronically-implanted Electrocorticographic Electrode Grid in a Non-human Primate

PubMed Central

Degenhart, Alan D.; Eles, James; Dum, Richard; Mischel, Jessica L.; Smalianchuk, Ivan; Endler, Bridget; Ashmore, Robin C.; Tyler-Kabara, Elizabeth C.; Hatsopoulos, Nicholas G.; Wang, Wei; Batista, Aaron P.; Cui, X. Tracy

2016-01-01

Electrocorticography (ECoG), used as a neural recording modality for brain-machine interfaces (BMIs), potentially allows for field potentials to be recorded from the surface of the cerebral cortex for long durations without suffering the host-tissue reaction to the extent that it is common with intracortical microelectrodes. Though the stability of signals obtained from chronically-implanted ECoG electrodes has begun receiving attention, to date little work has characterized the effects of long-term implantation of ECoG electrodes on underlying cortical tissue. We implanted a high-density ECoG electrode grid subdurally over cortical motor areas of a Rhesus macaque for 666 days. Histological analysis revealed minimal damage to the cortex underneath the implant, though the grid itself was encapsulated in collagenous tissue. We observed macrophages and foreign body giant cells at the tissue-array interface, indicative of a stereotypical foreign body response. Despite this encapsulation, cortical modulation during reaching movements was observed more than 18 months post-implantation. These results suggest that ECoG may provide a means by which stable chronic cortical recordings can be obtained with comparatively little tissue damage, facilitating the development of clinically-viable brain-machine interface systems. PMID:27351722

Histological evaluation of a chronically-implanted electrocorticographic electrode grid in a non-human primate

NASA Astrophysics Data System (ADS)

Degenhart, Alan D.; Eles, James; Dum, Richard; Mischel, Jessica L.; Smalianchuk, Ivan; Endler, Bridget; Ashmore, Robin C.; Tyler-Kabara, Elizabeth C.; Hatsopoulos, Nicholas G.; Wang, Wei; Batista, Aaron P.; Cui, X. Tracy

2016-08-01

Objective. Electrocorticography (ECoG), used as a neural recording modality for brain-machine interfaces (BMIs), potentially allows for field potentials to be recorded from the surface of the cerebral cortex for long durations without suffering the host-tissue reaction to the extent that it is common with intracortical microelectrodes. Though the stability of signals obtained from chronically implanted ECoG electrodes has begun receiving attention, to date little work has characterized the effects of long-term implantation of ECoG electrodes on underlying cortical tissue. Approach. We implanted and recorded from a high-density ECoG electrode grid subdurally over cortical motor areas of a Rhesus macaque for 666 d. Main results. Histological analysis revealed minimal damage to the cortex underneath the implant, though the grid itself was encapsulated in collagenous tissue. We observed macrophages and foreign body giant cells at the tissue-array interface, indicative of a stereotypical foreign body response. Despite this encapsulation, cortical modulation during reaching movements was observed more than 18 months post-implantation. Significance. These results suggest that ECoG may provide a means by which stable chronic cortical recordings can be obtained with comparatively little tissue damage, facilitating the development of clinically viable BMI systems.

An online brain-machine interface using decoding of movement direction from the human electrocorticogram

NASA Astrophysics Data System (ADS)

Milekovic, Tomislav; Fischer, Jörg; Pistohl, Tobias; Ruescher, Johanna; Schulze-Bonhage, Andreas; Aertsen, Ad; Rickert, Jörn; Ball, Tonio; Mehring, Carsten

2012-08-01

A brain-machine interface (BMI) can be used to control movements of an artificial effector, e.g. movements of an arm prosthesis, by motor cortical signals that control the equivalent movements of the corresponding body part, e.g. arm movements. This approach has been successfully applied in monkeys and humans by accurately extracting parameters of movements from the spiking activity of multiple single neurons. We show that the same approach can be realized using brain activity measured directly from the surface of the human cortex using electrocorticography (ECoG). Five subjects, implanted with ECoG implants for the purpose of epilepsy assessment, took part in our study. Subjects used directionally dependent ECoG signals, recorded during active movements of a single arm, to control a computer cursor in one out of two directions. Significant BMI control was achieved in four out of five subjects with correct directional decoding in 69%-86% of the trials (75% on average). Our results demonstrate the feasibility of an online BMI using decoding of movement direction from human ECoG signals. Thus, to achieve such BMIs, ECoG signals might be used in conjunction with or as an alternative to intracortical neural signals.

Clinical and Patient-reported Outcomes in Patients with Psoriatic Arthritis (PsA) by Body Surface Area Affected by Psoriasis: Results from the Corrona PsA/Spondyloarthritis Registry.

PubMed

Mease, Philip J; Karki, Chitra; Palmer, Jacqueline B; Etzel, Carol J; Kavanaugh, Arthur; Ritchlin, Christopher T; Malley, Wendi; Herrera, Vivian; Tran, Melody; Greenberg, Jeffrey D

2017-08-01

Psoriatic arthritis (PsA) is commonly comorbid with psoriasis; the extent of skin lesions is a major contributor to psoriatic disease severity/burden. We evaluated whether extent of skin involvement with psoriasis [body surface area (BSA) > 3% vs ≤ 3%] affects overall clinical and patient-reported outcomes (PRO) in patients with PsA. Using the Corrona PsA/Spondyloarthritis Registry, patient characteristics, disease activity, and PRO at registry enrollment were assessed for patients with PsA aged ≥ 18 years with BSA > 3% versus ≤ 3%. Regression models were used to evaluate associations of BSA level with outcome [modified minimal disease activity (MDA), Health Assessment Questionnaire (HAQ) score, patient-reported pain and fatigue, and the Work Productivity and Activity Impairment questionnaire score]. Adjustments were made for age, sex, race, body mass index, disease duration, and history of biologics, disease-modifying antirheumatic drug, and prednisone use. This analysis included 1240 patients with PsA with known BSA level (n = 451, BSA > 3%; n = 789, BSA ≤ 3%). After adjusting for potential confounding variables, patients with BSA > 3% versus ≤ 3% had greater patient-reported pain and fatigue and higher HAQ scores (p = 2.33 × 10 -8 , p = 0.002, and p = 1.21 × 10 -7 , respectively), were 1.7× more likely not to be in modified MDA (95% CI 1.21-2.41, p = 0.002), and were 2.1× more likely to have overall work impairment (1.37-3.21, p = 0.0001). These Corrona Registry data show that substantial skin involvement (BSA > 3%) is associated with greater PsA disease burden, underscoring the importance of assessing and effectively managing psoriasis in patients with PsA because this may be a contributing factor in PsA severity.

Chinese expert consensus on multidisciplinary diagnosis and treatment of hepatocellular carcinoma with portal vein tumor thrombus: 2016 edition.

PubMed

Cheng, Shuqun; Chen, Minshan; Cai, Jianqiang

2017-01-31

Hepatocellular carcinoma is the fourth leading cause of cancer-related morbidity and mortality in China. Portal vein tumor thrombus (PVTT) is common and it worsens prognosis of hepatocellular carcinoma (HCC). There is no internationally accepted consensus or guideline for diagnosis and treatment of HCC with PVTT. Based on existing evidences and common current practices, Chinese Experts on Multidisciplinary Diagnosis and Treatment of HCC with portal vein tumor thrombus met to develop a national consensus on diagnosis and treatment of HCC with PVTT. The meeting concluded with the First Edition (version 2016) of consensus statements with grades of evidence given as grades Ia, Ib, IIa, IIb, III and IV, and ranking as Classes A, B, C, D and I for quality of evidence and strength of recommendation by the United State Preventive Service Task Force, respectively. The consensus suggests recommended treatment to be based on patients' PVTT type and ECOG functional status; surgery being the preferred treatment for Child-Pugh A, PVTT type I/II, and ECOG PS 0-1; transcatheter arterial chemoembolization (TACE) for non-resectable PVTT I/II and Child-Pugh A; and radiotherapy for non-resectable PVTT I/II/III and Child-Pugh A. Symptomatic treatment is recommended for Child-Pugh C, with massive ascites or gastrointestinal bleeding. By updating clinicians with treatment options for HCC with PVTT, the consensus statement aimed to prolong overall survival and to improve quality of life of patients with minimal treatment complication. Future treatment strategies for HCC with PVTT in China would depend on new evidences from more future clinical trials, especially studies defining the role of traditional Chinese medicine and clarifying molecular aspects of HCC.

Development and psychometric testing of the Adaptive Capacity Index, an instrument to measure adaptive capacity in individuals with advanced cancer.

PubMed

Olson, K; Rogers, W T; Cui, Y; Cree, M; Baracos, V; Rust, T; Mellott, I; Johnson, L; Macmillan, K; Bonville, N

2011-08-01

We have proposed that declines in adaptive capacity, defined as the ability to adapt to multiple stressors, may serve as an indicator of risk for fatigue. A comprehensive measure of adaptive capacity does not exist. In this paper we describe construction of an instrument to measure adaptive capacity, the Adaptive Capacity Index (ACI). Descriptive and psychometric. Six sites providing palliative care in Western Canada. ≥18 years old, diagnosed with advanced cancer, able to read and write English, Mini-Mental Status Exam score ≥22. Pilot study n=48; Main study n=225 stratified using the Edmonton Symptom Assessment Scale (ESAS) tiredness score (≥0 to ≤2 n=60; ≥3 to ≤6 n=108; ≥7 and ≤10 n=57). Following ethics approval, 17 experts in symptom management assisted with content validation and consenting individuals completed the Functional Assessment of Cancer Therapy-Fatigue (FACT-F), the Profile of Mood States-Vigor short form (POMS-Vsf), and the ACI. A research assistant collected demographic information and assigned an Eastern Cooperative Oncology Group (ECOG) score. Data were analyzed using descriptive and inferential statistics (i.e., exploratory factor analyses, correlation, multivariate analyses of variance, and multiple regression). Five 6-item ACI factors/subscales (Cognitive Function, Stamina/Muscle Endurance, Sleep Quality, Emotional Reactivity, and Social Interaction) were identified. The ACI-total scale and its subscales were internally consistent (Cronbach's alpha 0.76-0.89), and were significantly correlated with each other, and with each fatigue measure (Pearson's r ranging from -0.724 to 0.634). The ACI total score was sensitive to changes in the ESAS tiredness score. Stamina/Muscle Endurance, Cognitive Function, and Sleep Quality predicted 60.8% of the variance in FACT-F. Stamina/Muscle Endurance and Social Interaction predicted 36.8% of the variance in POMS-Vsf. Stamina/Muscle Endurance and Sleep Quality predicted 8% of the variance in ECOG. The ACI is reliable and has beginning evidence of validity. In future studies we will examine relationships between ACI subscale scores and subsequent increases in fatigue and explore linkages to physiological processes. We will also establish ACI norms for early and late stage cancers and explore variations in ACI subscale scores base on age or gender. Copyright © 2011 Elsevier Ltd. All rights reserved.

Scoring haemophilic arthropathy on X-rays: improving inter- and intra-observer reliability and agreement using a consensus atlas.

PubMed

Foppen, Wouter; van der Schaaf, Irene C; Beek, Frederik J A; Verkooijen, Helena M; Fischer, Kathelijn

2016-06-01

The radiological Pettersson score (PS) is widely applied for classification of arthropathy to evaluate costly haemophilia treatment. This study aims to assess and improve inter- and intra-observer reliability and agreement of the PS. Two series of X-rays (bilateral elbows, knees, and ankles) of 10 haemophilia patients (120 joints) with haemophilic arthropathy were scored by three observers according to the PS (maximum score 13/joint). Subsequently, (dis-)agreement in scoring was discussed until consensus. Example images were collected in an atlas. Thereafter, second series of 120 joints were scored using the atlas. One observer rescored the second series after three months. Reliability was assessed by intraclass correlation coefficients (ICC), agreement by limits of agreement (LoA). Median Pettersson score at joint level (PSjoint) of affected joints was 6 (interquartile range 3-9). Using the consensus atlas, inter-observer reliability of the PSjoint improved significantly from 0.94 (95 % confidence interval (CI) 0.91-0.96) to 0.97 (CI 0.96-0.98). LoA improved from ±1.7 to ±1.1 for the PSjoint. Therefore, true differences in arthropathy were differences in the PSjoint of >2 points. Intra-observer reliability of the PSjoint was 0.98 (CI 0.97-0.98), intra-observer LoA were ±0.9 points. Reliability and agreement of the PS improved by using a consensus atlas. • Reliability of the Pettersson score significantly improved using the consensus atlas. • The presented consensus atlas improved the agreement among observers. • The consensus atlas could be recommended to obtain a reproducible Pettersson score.

On the Importance of Reliable Covariate Measurement in Selection Bias Adjustments Using Propensity Scores

ERIC Educational Resources Information Center

Steiner, Peter M.; Cook, Thomas D.; Shadish, William R.

2011-01-01

The effect of unreliability of measurement on propensity score (PS) adjusted treatment effects has not been previously studied. The authors report on a study simulating different degrees of unreliability in the multiple covariates that were used to estimate the PS. The simulation uses the same data as two prior studies. Shadish, Clark, and Steiner…

Quality of Life and Performance Status From a Substudy Conducted Within a Prospective Phase 3 Randomized Trial of Concurrent Accelerated Radiation Plus Cisplatin With or Without Cetuximab for Locally Advanced Head and Neck Carcinoma: NRG Oncology Radiation Therapy Oncology Group 0522.

PubMed

Truong, Minh Tam; Zhang, Qiang; Rosenthal, David I; List, Marcie; Axelrod, Rita; Sherman, Eric; Weber, Randal; Nguyen-Tân, Phuc Felix; El-Naggar, Adel; Konski, André; Galvin, James; Schwartz, David; Trotti, Andy; Silverman, Craig; Singh, Anurag; Godette, Karen; Bonner, James A; Jones, Christopher U; Garden, Adam S; Shenouda, George; Matthiesen, Chance; Le, Quynh-Thu; Bruner, Deborah

2017-03-15

To analyze the quality of life (QOL) and performance status (PS) (secondary outcome) in patients with stage III to IV head and neck cancer (HNC) enrolled on a prospective randomized phase 3 trial comparing radiation-cisplatin without cetuximab (CIS) or with cetuximab (CET/CIS). The QOL hypothesis proposed a between-arm difference in Functional Assessment of Cancer Therapy-Head and Neck (FACT-HN) total score of ≥10% of the instrument range from baseline to 1 year. Patients who gave consent to the QOL/PS study completed the FACT-HN, Performance Status Scale for HNC (PSS-HN), and EuroQol (EQ-5D) at baseline through to 5 years. The pretreatment QOL/PS scores were correlated with outcome and p16 status in patients with oropharyngeal cancer (OPC). Of 818 analyzable patients, the 1-year change from baseline score for FACT-HN total was -0.41 (CIS arm) and -5.11 (CET/CIS arm) (P=.016), representing a 3.2% between-arm change of the FACT-HN total score. The mean EQ-5D index and PSS-HN scores were not significantly different between arms. The p16-positive OPC patients had significantly higher baseline and 1-year scores for PSS-HN, FACT-HN total, physical and functional subscales, and 2-years for the EQ-5D index compared with p16-negative OPC patients. Higher pretreatment PSS-HN diet, PSS-HN eating, FACT-HN, and EQ-5D index scores were associated with better overall survival (OS) and progression-free (PFS) survival on multivariate analysis. Higher baseline FACT-HN total, functional, physical subscale, and EQ-5D index scores were associated with improved OS and PFS in p16-positive OPC patients but not in p16-negative and non-OPC patients. There was no clinically meaningful difference in QOL/PS between arms. The p16-positive OPC patients had significantly higher QOL/PS than did p16-negative patients. Pretreatment QOL/PS is a significant independent predictor of outcome in locally advanced HNC. Copyright © 2016 Elsevier Inc. All rights reserved.

Structured learning for robotic surgery utilizing a proficiency score: a pilot study.

PubMed

Hung, Andrew J; Bottyan, Thomas; Clifford, Thomas G; Serang, Sarfaraz; Nakhoda, Zein K; Shah, Swar H; Yokoi, Hana; Aron, Monish; Gill, Inderbir S

2017-01-01

We evaluated feasibility and benefit of implementing structured learning in a robotics program. Furthermore, we assessed validity of a proficiency assessment tool for stepwise graduation. Teaching cases included robotic radical prostatectomy and partial nephrectomy. Procedure steps were categorized: basic, intermediate, and advanced. An assessment tool ["proficiency score" (PS)] was developed to evaluate ability to safely and autonomously complete a step. Graduation required a passing PS (PS ≥ 3) on three consecutive attempts. PS and validated global evaluative assessment of robotic skills (GEARS) were evaluated for completed steps. Linear regression was utilized to determine postgraduate year/PS relationship (construct validity). Spearman's rank correlation coefficient measured correlation between PS and GEARS evaluations (concurrent validity). Intraclass correlation (ICC) evaluated PS agreement between evaluator classes. Twenty-one robotic trainees participated within the pilot program, completing a median of 14 (2-69) cases each. Twenty-three study evaluators scored 14 (1-60) cases. Over 4 months, 229/294 (78 %) cases were designated "teaching" cases. Residents completed 91 % of possible evaluations; faculty completed 78 %. Verbal and quantitative feedback received by trainees increased significantly (p = 0.002, p < 0.001, respectively). Average PS increased with PGY (post-graduate year) for basic and intermediate steps (regression slopes: 0.402 (p < 0.0001), 0.323 (p < 0.0001), respectively) (construct validation). Overall, PS correlated highly with GEARS (ρ = 0.81, p < 0.0001) (concurrent validity). ICC was 0.77 (95 % CI 0.61-0.88) for resident evaluations. Structured learning can be implemented in an academic robotic program with high levels of trainee and evaluator participation, encouraging both quantitative and verbal feedback. A proficiency assessment tool developed for step-specific proficiency has construct and concurrent validity.

Study on localization of epileptic focus based on causality analysis

NASA Astrophysics Data System (ADS)

Shan, Shaojie; Li, Hanjun; Tang, Xiaoying

2018-05-01

In this paper, we considered that the ECoG signal contain abundant pathological information, which can be used for the localization of epileptic focus before epileptic seizures in 1-2 mins. In order to validate this hypothesis, cutting the ECoG into three stages: before seizure, seizure and after seizure, then through using Granger causality algorithm, PSI causality algorithm, Transfer Entropy causality algorithm at different stages of epilepsy ECoG, we were able to do the causality analysis of ECoG data. The results have shown that there is significant difference with the causality value of the epileptic focus area in before seizure, seizure and after seizure. An increase is in the causality value of each channel during epileptic seizure. After epileptic seizure, the causality between the channels showed a downward trend, but the difference was not obvious. The difference of the causality provides a reliable technical method to assist the clinical diagnosis of epileptic focus.

Which Propensity Score Method Best Reduces Confounder Imbalance? An Example From a Retrospective Evaluation of a Childhood Obesity Intervention.

PubMed

Schroeder, Krista; Jia, Haomiao; Smaldone, Arlene

Propensity score (PS) methods are increasingly being employed by researchers to reduce bias arising from confounder imbalance when using observational data to examine intervention effects. The purpose of this study was to examine PS theory and methodology and compare application of three PS methods (matching, stratification, weighting) to determine which best improves confounder balance. Baseline characteristics of a sample of 20,518 school-aged children with severe obesity (of whom 1,054 received an obesity intervention) were assessed prior to PS application. Three PS methods were then applied to the data to determine which showed the greatest improvement in confounder balance between the intervention and control group. The effect of each PS method on the outcome variable-body mass index percentile change at one year-was also examined. SAS 9.4 and Comprehensive Meta-analysis statistical software were used for analyses. Prior to PS adjustment, the intervention and control groups differed significantly on seven of 11 potential confounders. PS matching removed all differences. PS stratification and weighting both removed one difference but created two new differences. Sensitivity analyses did not change these results. Body mass index percentile at 1 year decreased in both groups. The size of the decrease was smaller in the intervention group, and the estimate of the decrease varied by PS method. Selection of a PS method should be guided by insight from statistical theory and simulation experiments, in addition to observed improvement in confounder balance. For this data set, PS matching worked best to correct confounder imbalance. Because each method varied in correcting confounder imbalance, we recommend that multiple PS methods be compared for ability to improve confounder balance before implementation in evaluating treatment effects in observational data.

In-vivo animation of midazolam-induced electrocorticographic changes in humans.

PubMed

Nishida, Masaaki; Sood, Sandeep; Asano, Eishi

2009-12-15

Previous human studies have demonstrated that midazolam-induced signal changes on scalp EEG recording include widespread augmentation of sigma-oscillations and that the amplitude of such oscillations is correlated to the severity of midazolam-induced amnesia. Still unanswered questions include whether midazolam-induced sigma-augmentation also involves the medial temporal region, which plays a role in memory encoding. Taking advantage of rare and unique opportunities to monitor neuronal activities using intracranial electrocorticography (ECoG) recording, we determined how intravenous administration of midazolam elicited spectral frequency changes in the human cerebral cortex, including the medial temporal region. We studied three children with focal epilepsy who underwent subdural electrode placement and extraoperative ECoG recording for subsequent resection of the seizure focus; an intravenous bolus of midazolam was given to abort an ongoing simple partial seizure or to provide sedation prior to induction of general anesthesia. 'Midazolam-induced ECoG frequency alteration' in sites distant from the seizure focus was sequentially animated on their individual three-dimensional MR images. The common ECoG changes induced by midazolam included gradual augmentation of sigma-oscillations (12-16 Hz) in the widespread non-epileptic regions, including the medial temporal region. The spatial and temporal alteration of ECoG spectral frequency pattern can be appreciated via animation movies. Midazolam-induced sigma-augmentation was observed in the medial temporal region in our relatively small cohort of human subjects. In-vivo animation of ECoG spectral measures provided a unique situation to study the effect of midazolam on neuronal processing in the deep brain regions.

Multimodality language mapping in patients with left-hemispheric language dominance on Wada test.

PubMed

Kojima, Katsuaki; Brown, Erik C; Rothermel, Robert; Carlson, Alanna; Matsuzaki, Naoyuki; Shah, Aashit; Atkinson, Marie; Mittal, Sandeep; Fuerst, Darren; Sood, Sandeep; Asano, Eishi

2012-10-01

We determined the utility of electrocorticography (ECoG) and stimulation for detecting language-related sites in patients with left-hemispheric language-dominance on Wada test. We studied 13 epileptic patients who underwent language mapping using event-related gamma-oscillations on ECoG and stimulation via subdural electrodes. Sites showing significant gamma-augmentation during an auditory-naming task were defined as language-related ECoG sites. Sites at which stimulation resulted in auditory perceptual changes, failure to verbalize a correct answer, or sensorimotor symptoms involving the mouth were defined as language-related stimulation sites. We determined how frequently these methods revealed language-related sites in the superior-temporal, inferior-frontal, dorsolateral-premotor, and inferior-Rolandic regions. Language-related sites in the superior-temporal and inferior-frontal gyri were detected by ECoG more frequently than stimulation (p < 0.05), while those in the dorsolateral-premotor and inferior-Rolandic regions were detected by both methods equally. Stimulation of language-related ECoG sites, compared to the others, more frequently elicited language symptoms (p < 0.00001). One patient developed dysphasia requiring in-patient speech therapy following resection of the dorsolateral-premotor and inferior-Rolandic regions containing language-related ECoG sites not otherwise detected by stimulation. Language-related gamma-oscillations may serve as an alternative biomarker of underlying language function in patients with left-hemispheric language-dominance. Measurement of language-related gamma-oscillations is warranted in presurgical evaluation of epileptic patients. Copyright © 2012 International Federation of Clinical Neurophysiology. Published by Elsevier Ireland Ltd. All rights reserved.

In-vivo animation of midazolam-induced electrocorticographic changes in humans

PubMed Central

Nishida, Masaaki; Sood, Sandeep; Asano, Eishi

2009-01-01

Previous human studies have demonstrated that midazolam-induced signal changes on scalp EEG recording include widespread augmentation of sigma-oscillations and that the amplitude of such oscillations is correlated to the severity of midazolam-induced amnesia. Still unanswered questions include whether midazolam-induced sigma-augmentation also involves the medial temporal region, which plays a role in memory encoding. Taking advantage of rare and unique opportunities to monitor neuronal activities using intracranial electrocorticography (ECoG) recording, we determined how intravenous administration of midazolam induced spectral frequency changes in the human cerebral cortex, including the medial temporal region. We studied three children with focal epilepsy who underwent subdural electrode placement and extraoperative ECoG recording for subsequent resection of the seizure focus; an intravenous bolus of midazolam was given to abort an ongoing simple-partial seizure or to provide sedation prior to induction of general anesthesia. ‘Midazolam-induced ECoG frequency alteration’ in sites distant from the seizure focus was sequentially animated on their individual three-dimensional MR images. The common ECoG changes induced by midazolam included gradual augmentation of sigma-oscillations (12-16 Hz) in the widespread non-epileptic regions, including the medial temporal region. The spatial and temporal alteration of ECoG spectral frequency pattern can be appreciated via animation movies. Midazolam-induced sigma-augmentation was observed in the medial temporal region in our relatively small cohort of human subjects. In-vivo animation of ECoG spectral measures provided a unique situation to study the effect of midazolam on neuronal processing in the deep brain regions. PMID:19733366

Wet needling of myofascial trigger points in abdominal muscles for treatment of primary dysmenorrhoea.

PubMed

Huang, Qiang-Min; Liu, Lin

2014-08-01

To evaluate the effect of wet needling (related to acupuncture) and home stretching exercises on myofascial trigger points (MTrPs) in abdominal muscles for the treatment of dysmenorrhoea. The effect of wet needing of MTrPs in abdominal muscles, supplemented by home stretching exercises, was observed in 65 patients with moderate and severe primary dysmenorrhoea. The MTrPs in the abdominal region were localised and repeatedly needled with lidocaine injection. Menstrual pain was evaluated with a Visual Analogue Scale (VAS) score after every treatment, with the final evaluation made at a 1-year follow-up. Treatment was stopped when the VAS pain score reduced to ≤3. Symptoms scores were analysed with one-way analysis of variance. The mean VAS pain score before treatment was 7.49±1.16. After a single wet needling session, 41 patients had a reduction in their VAS pain score to <3 during their following menstrual cycle, with a mean of 1.63±0.49. Twenty-four patients who needed two treatments showed a reduction in menstrual pain scores to 0.58±0.50. After 1 year, the mean VAS pain score among all patients was 0.28±0.45, with a response rate of 100%. Primary dysmenorrhoea was significantly reduced 1 year after wet needling to MTrPs in the abdominal region and home stretching exercises, justifying further research with controlled trials. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

A Test of the Empirical Profile and Coherence of the DSM-5 Psychopathy Specifier.

PubMed

Miller, Joshua D; Lamkin, Joanna; Maples-Keller, Jessica L; Sleep, Chelsea E; Lynam, Donald R

2017-11-13

The Diagnostic and Statistical Manual of Mental Disorders-5th edition (DSM-5; American Psychiatric Association, 2013) introduced a psychopathy specifier (DSM-5 PS) as part of the Section III diagnostic model of antisocial personality disorder. Designed to capture the construct of fearless dominance/boldness, the DSM-5 PS is assessed on the basis of the presence of low scores on traits of withdrawal and anxiousness, and high scores on attention seeking. These constructs have garnered attention in the past decade but are the subject of substantial debate as to their role in the conceptualization and assessment of psychopathy, given their limited relations to the maladaptive outcomes typically associated with this personality disorder. In the current study (N = 340 undergraduates; 170 informants), we examined the DSM-5 PS, both in composite form and its trait subscales, to investigate the degree to which the DSM-5 PS manifested empirical profiles associated with psychopathy and its maladaptive correlates. Consistent with prior fearless dominance/boldness research, the DSM-5 PS manifested limited relations with other components of psychopathy, symptoms of DSM-5 Section II and III antisocial personality disorder, and self- and informant-related impairment scores. When examined at the individual subscale level, the 3 DSM-5 PS subscales manifested only partially overlapping profiles and only 1 of the 3-Attention Seeking-demonstrated an association with maladaptivity (e.g., externalizing behaviors). These findings raise important concerns about the coherence and utility of the DSM-5 PS as a diagnostic specifier included in a psychiatric nosology. (PsycINFO Database Record (c) 2017 APA, all rights reserved).

SymptoMScreen: A Tool for Rapid Assessment of Symptom Severity in MS Across Multiple Domains.

PubMed

Green, R; Kalina, J; Ford, R; Pandey, K; Kister, I

2017-01-01

The objective of this study was to describe SymptoMScreen, an in-house developed tool for rapid assessment of MS symptom severity in routine clinical practice, and to validate SymptoMScreen against Performance Scales (PS). MS patients typically experience symptoms in many neurologic domains. A tool that would enable MS patients to efficiently relay their symptom severity across multiple domains to the healthcare providers could lead to improved symptom management. We developed "SymptoMScreen," a battery of 7-point Likert scales for 12 distinct domains commonly affected by MS: mobility, dexterity, body pain, sensation, bladder function, fatigue, vision, dizziness, cognition, depression, and anxiety. We administered SymptoMScreen and PS scales to consecutive MS patients at a specialty MS Care Center. We assessed the criterion and construct validity of SymptoMScreen by calculating Spearmen rank correlations between the SymptoMScreen composite score and PS composite score, and between SymptoMScreen subscale and the respective PS subscale scores, where applicable. A total of 410 patients with MS (age 46.6 ± 12.9 years; 74% female; mean disease duration 12.2 ± 8.7 years) completed the SymptoMScreen and PSs during their clinic visit. Composite SymptoMScreen score correlated strongly with combined PS score (r = 0.88, p < 0.0001). SymptoMScreen sub scores correlated strongly with the criterion measures of the respective PS (r = 0.69-0.87, p < 0.0001). Test-retest reliability of SymptoMScreen and its subscales was excellent (r = 0.71-0.94, p < .0001). SymptoMScreen is a single-page battery of Likert scales that assesses symptom impact in 12 domains commonly affected in MS. It has excellent criterion and construct validity. SymptoMScreen is patient and clinician friendly, takes approximately one minute to complete, and can help better document, understand, and manage patients' symptoms in routine clinical practice. SymptoMScreen is freely available to clinicians and researchers.

Quality of life following trauma before and after implementation of a physician-staffed helicopter.

PubMed

Funder, K S; Rasmussen, L S; Hesselfeldt, R; Siersma, V; Lohse, N; Sonne, A; Wulffeld, S; Steinmetz, J

2017-01-01

Implementation of a physician-staffed helicopter emergency medical service (PS-HEMS) in Denmark was associated with lower 30-day mortality in severely injured trauma patients and less time on social subsidy. However, the reduced 30-day mortality in severely injured patients might be at the expense of a worse functional outcome and quality of life (QoL) in those who survive. The aim of this study was to investigate the effect of a physician-staffed helicopter on long-term QoL in trauma patients. Prospective, observational study including trauma patients who survived at least 3 years after injury. A 5-month period prior to PS-HEMS implementation was compared with the first 12 months after PS-HEMS implementation. QoL was assessed 4.5 years after trauma by the SF-36 questionnaire. Primary endpoint was the Physical Component Summary score. Of the 1994 patients assessed by a trauma team, 1521 were eligible for inclusion in the study. Of these, 566 (37%) gave consent to participate and received a questionnaire by mail, and 402 (71%) of them returned the questionnaire (n = 114 before PS-HEMS; n = 288 after PS-HEMS implementation). Older patients, women and patients with trauma in the after PS-HEMS period were more likely to return the questionnaire. No significant association between QoL and period (before vs. after PS-HEMS) was found; the Physical Component Summary scores were 50.0 and 50.9 in the before and after PS-HEMS periods, respectively (P = 0.47). We also found no difference on multivariable analysis with adjustment for sex, age and injury severity score. No significant difference in QoL among trauma patients was found after implementation of a PS-HEMS. © 2016 The Authors. Acta Anaesthesiologica Scandinavica published by John Wiley & Sons Ltd on behalf of Acta Anaesthesiologica Scandinavica Foundation.

Psychometric properties of the OARSI/OMERACT osteoarthritis pain and functional impairment scales: ICOAP, KOOS-PS and HOOS-PS.

PubMed

Ruyssen-Witrand, A; Fernandez-Lopez, C J; Gossec, L; Anract, P; Courpied, J P; Dougados, M

2011-01-01

To evaluate the psychometric properties of the OARSI-OMERACT questionnaires in comparison to the existing validated scales. Consecutive hip or knee osteoarthritis patients consulting in an orthopedic department were enrolled in the study. Data collected were pain using the Intermittent and Constant Osteoarthritis Pain (ICOAP), a Numeric Rating Scale (NRS), the Western Ontario McMaster Universities' Osteoarthritis Index (WOMAC) pain subscale, the Lequesne pain subscale; functional impairment using the Knee disability and Osteoarthritis Outcome Score-Physical Function Shortform (KOOS-PS), the Hip disability and Osteoarthritis Outcome Score-Physical Function Shortform (HOOS-PS), a NRS, the WOMAC function sub-scale, the Lequesne function subscale. Validity was assessed by calculating the Spearman's correlation coefficient between all the scales. Reliability was assessed in out-patients with stable disease comparing the data collected within 2 weeks using the intra-class correlation coefficient (ICC). Responsiveness was assessed on the data from hospitalised patients prior to and 12 weeks after a total joint replacement (TJR) using the standardised response mean. Three hundred patients (mean age=68 years, females=62%, hip OA=57%) were included. There was a moderate to good correlation between ICOAP, KOOS-PS, HOOS-PS and the WOMAC, NRS and Lequesne scales. Reliability of the ICOAP hip OA HOOS-PS and KOOS-PS was good (ICC range 0.80-0.81) whereas it was moderate for knee ICOAP (ICC=0.65). Responsiveness of the ICOAP, KOOS-PS and HOOS-PS 12 weeks after TJR was comparable to responsiveness of other scales (SRM range: 0.54-1.82). The psychometric properties of the ICOAP, KOOS-PS and HOOS-PS were comparable to those of the WOMAC, Lequesne and NRS.

A procedural skills OSCE: assessing technical and non-technical skills of internal medicine residents.

PubMed

Pugh, Debra; Hamstra, Stanley J; Wood, Timothy J; Humphrey-Murto, Susan; Touchie, Claire; Yudkowsky, Rachel; Bordage, Georges

2015-03-01

Internists are required to perform a number of procedures that require mastery of technical and non-technical skills, however, formal assessment of these skills is often lacking. The purpose of this study was to develop, implement, and gather validity evidence for a procedural skills objective structured clinical examination (PS-OSCE) for internal medicine (IM) residents to assess their technical and non-technical skills when performing procedures. Thirty-five first to third-year IM residents participated in a 5-station PS-OSCE, which combined partial task models, standardized patients, and allied health professionals. Formal blueprinting was performed and content experts were used to develop the cases and rating instruments. Examiners underwent a frame-of-reference training session to prepare them for their rater role. Scores were compared by levels of training, experience, and to evaluation data from a non-procedural OSCE (IM-OSCE). Reliability was calculated using Generalizability analyses. Reliabilities for the technical and non-technical scores were 0.68 and 0.76, respectively. Third-year residents scored significantly higher than first-year residents on the technical (73.5 vs. 62.2%) and non-technical (83.2 vs. 75.1%) components of the PS-OSCE (p < 0.05). Residents who had performed the procedures more frequently scored higher on three of the five stations (p < 0.05). There was a moderate disattenuated correlation (r = 0.77) between the IM-OSCE and the technical component of the PS-OSCE scores. The PS-OSCE is a feasible method for assessing multiple competencies related to performing procedures and this study provides validity evidence to support its use as an in-training examination.

Mental health related determinants of parenting stress among urban mothers of young children--results from a birth-cohort study in Ghana and Côte d'Ivoire.

PubMed

Guo, Nan; Bindt, Carola; Te Bonle, Marguerite; Appiah-Poku, John; Tomori, Cecilia; Hinz, Rebecca; Barthel, Dana; Schoppen, Stefanie; Feldt, Torsten; Barkmann, Claus; Koffi, Mathurin; Loag, Wibke; Nguah, Samuel Blay; Eberhardt, Kirsten A; Tagbor, Harry; Bass, Judith K; N'Goran, Eliezer; Ehrhardt, Stephan

2014-05-29

There are limited data on the parenting stress (PS) levels in sub-Saharan African mothers and on the association between ante- and postnatal depression and anxiety on PS. A longitudinal birth cohort of 577 women from Ghana and Côte d'Ivoire was followed from the 3rd trimester in pregnancy to 2 years postpartum between 2010 and 2013. Depression and anxiety were assessed by the Patient Health Questionnaire depression module (PHQ-9) and the Generalized Anxiety Disorder (GAD-7) at baseline, 3 month, 12 month and 24 month postpartum. PS was measured using the Parenting Stress Index-Short Form (PSI-SF) at 3, 12 and 24 month. The mean total PS score and the subscale scores were compared among depressed vs. non-depressed and among anxious vs. non-anxious mothers at 3, 12 and 24 month postpartum. The proportions of clinical PS (PSI-SF raw score > 90) in depressed vs. non-depressed and anxious vs. non-anxious mothers were also compared. A generalized estimating equation (GEE) approach was used to estimate population-averaged associations between women's depression/anxiety and PS adjusting for age, child sex, women's anemia, education, occupation, spouse's education, and number of sick child visits. A total of 577, 531 and 264 women completed the PS assessment at 3 month, 12 month and 24 month postpartum across the two sites and the prevalences of clinical PS at each time point was 33.1%, 24.4% and 14.9% in Ghana and 30.2%, 33.5% and 22.6% in Côte d'Ivoire, respectively. At all three time points, the PS scores were significantly higher among depressed mothers vs. non-depressed mothers. In the multivariate regression analyses, antepartum and postpartum depression were consistently associated with PS after adjusting for other variables. Parenting stress is frequent and levels are high compared with previous studies from high-income countries. Antepartum and postpartum depression were both associated with PS, while antepartum and postpartum anxiety were not after adjusting for confounders. More quantitative and qualitative data are needed in sub-Saharan African populations to assess the burden of PS and understand associated mechanisms. Should our findings be replicated, it appears prudent to design and subsequently evaluate intervention strategies.

A fully integrated wireless system for intracranial direct cortical stimulation, real-time electrocorticography data transmission, and smart cage for wireless battery recharge.

PubMed

Piangerelli, Marco; Ciavarro, Marco; Paris, Antonino; Marchetti, Stefano; Cristiani, Paolo; Puttilli, Cosimo; Torres, Napoleon; Benabid, Alim Louis; Romanelli, Pantaleo

2014-01-01

Wireless transmission of cortical signals is an essential step to improve the safety of epilepsy procedures requiring seizure focus localization and to provide chronic recording of brain activity for Brain Computer Interface (BCI) applications. Our group developed a fully implantable and externally rechargeable device, able to provide wireless electrocorticographic (ECoG) recording and cortical stimulation (CS). The first prototype of a wireless multi-channel very low power ECoG system was custom-designed to be implanted on non-human primates. The device, named ECOGIW-16E, is housed in a compact hermetically sealed Polyether ether ketone (PEEK) enclosure, allowing seamless battery recharge. ECOGIW-16E is recharged in a wireless fashion using a special cage designed to facilitate the recharge process in monkeys and developed in accordance with guidelines for accommodation of animals by Council of Europe (ETS123). The inductively recharging cage is made up of nylon and provides a thoroughly novel experimental setting on freely moving animals. The combination of wireless cable-free ECoG and external seamless battery recharge solves the problems and shortcomings caused by the presence of cables leaving the skull, providing a safer and easier way to monitor patients and to perform ECoG recording on primates. Data transmission exploits the newly available Medical Implant Communication Service band (MICS): 402-405 MHz. ECOGIW-16E was implanted over the left sensorimotor cortex of a macaca fascicularis to assess the feasibility of wireless ECoG monitoring and brain mapping through CS. With this device, we were able to record the everyday life ECoG signal from a monkey and to deliver focal brain stimulation with movement elicitation.

Monitoring fetal electrocortical activity during labour for predicting worsening acidemia: a prospective study in the ovine fetus near term.

PubMed

Frasch, Martin G; Keen, Ashley E; Gagnon, Robert; Ross, Michael G; Richardson, Bryan S

2011-01-01

Severe fetal acidemia during labour with arterial pH below 7.00 is associated with increased risk of hypoxic-ischemic brain injury. Electronic fetal heart rate (FHR) monitoring, the mainstay of intrapartum surveillance, has poor specificity for detecting fetal acidemia. We studied brain electrical activity measured with electrocorticogram (ECOG) in the near term ovine fetus subjected to repetitive umbilical cord occlusions (UCO) inducing FHR decelerations, as might be seen in human labour, to delineate the time-course for ECOG changes with worsening acidemia and thereby assess the potential clinical utility of fetal ECOG. Ten chronically catheterized fetal sheep were studied through a series of mild, moderate and severe UCO until the arterial pH was below 7.00. At a pH of 7.24 ± 0.04, 52 ± 13 min prior to the pH dropping <7.00, spectral edge frequency (SEF) increased to 23 ± 2 Hz from 3 ± 1 Hz during each FHR deceleration (p<0.001) and was correlated to decreases in FHR and in fetal arterial blood pressure during each FHR deceleration (p<0.001). The UCO-related changes in ECOG occurred in advance of the pH decreasing below 7.00. These ECOG changes may be a protective mechanism suppressing non-essential energy needs when oxygen supply to the fetal brain is decreased acutely. By detecting such "adaptive brain shutdown," the need for delivery in high risk pregnant patients may be more accurately predicted than with FHR monitoring alone. Therefore, monitoring fetal electroencephalogram (EEG, the human equivalent of ECOG) during human labour may be a useful adjunct to FHR monitoring.

Monitoring Fetal Electrocortical Activity during Labour for Predicting Worsening Acidemia: A Prospective Study in the Ovine Fetus Near Term

PubMed Central

Frasch, Martin G.; Keen, Ashley E.; Gagnon, Robert; Ross, Michael G.; Richardson, Bryan S.

2011-01-01

Background Severe fetal acidemia during labour with arterial pH below 7.00 is associated with increased risk of hypoxic-ischemic brain injury. Electronic fetal heart rate (FHR) monitoring, the mainstay of intrapartum surveillance, has poor specificity for detecting fetal acidemia. We studied brain electrical activity measured with electrocorticogram (ECOG) in the near term ovine fetus subjected to repetitive umbilical cord occlusions (UCO) inducing FHR decelerations, as might be seen in human labour, to delineate the time-course for ECOG changes with worsening acidemia and thereby assess the potential clinical utility of fetal ECOG. Methodology/Principal Findings Ten chronically catheterized fetal sheep were studied through a series of mild, moderate and severe UCO until the arterial pH was below 7.00. At a pH of 7.24±0.04, 52±13 min prior to the pH dropping <7.00, spectral edge frequency (SEF) increased to 23±2 Hz from 3±1 Hz during each FHR deceleration (p<0.001) and was correlated to decreases in FHR and in fetal arterial blood pressure during each FHR deceleration (p<0.001). Conclusions/Significance The UCO-related changes in ECOG occurred in advance of the pH decreasing below 7.00. These ECOG changes may be a protective mechanism suppressing non-essential energy needs when oxygen supply to the fetal brain is decreased acutely. By detecting such “adaptive brain shutdown,” the need for delivery in high risk pregnant patients may be more accurately predicted than with FHR monitoring alone. Therefore, monitoring fetal electroencephalogram (EEG, the human equivalent of ECOG) during human labour may be a useful adjunct to FHR monitoring. PMID:21789218

Decoding Individual Finger Movements from One Hand Using Human EEG Signals

PubMed Central

Gonzalez, Jania; Ding, Lei

2014-01-01

Brain computer interface (BCI) is an assistive technology, which decodes neurophysiological signals generated by the human brain and translates them into control signals to control external devices, e.g., wheelchairs. One problem challenging noninvasive BCI technologies is the limited control dimensions from decoding movements of, mainly, large body parts, e.g., upper and lower limbs. It has been reported that complicated dexterous functions, i.e., finger movements, can be decoded in electrocorticography (ECoG) signals, while it remains unclear whether noninvasive electroencephalography (EEG) signals also have sufficient information to decode the same type of movements. Phenomena of broadband power increase and low-frequency-band power decrease were observed in EEG in the present study, when EEG power spectra were decomposed by a principal component analysis (PCA). These movement-related spectral structures and their changes caused by finger movements in EEG are consistent with observations in previous ECoG study, as well as the results from ECoG data in the present study. The average decoding accuracy of 77.11% over all subjects was obtained in classifying each pair of fingers from one hand using movement-related spectral changes as features to be decoded using a support vector machine (SVM) classifier. The average decoding accuracy in three epilepsy patients using ECoG data was 91.28% with the similarly obtained features and same classifier. Both decoding accuracies of EEG and ECoG are significantly higher than the empirical guessing level (51.26%) in all subjects (p<0.05). The present study suggests the similar movement-related spectral changes in EEG as in ECoG, and demonstrates the feasibility of discriminating finger movements from one hand using EEG. These findings are promising to facilitate the development of BCIs with rich control signals using noninvasive technologies. PMID:24416360

High Spatiotemporal Resolution ECoG Recording of Somatosensory Evoked Potentials with Flexible Micro-Electrode Arrays.

PubMed

Kaiju, Taro; Doi, Keiichi; Yokota, Masashi; Watanabe, Kei; Inoue, Masato; Ando, Hiroshi; Takahashi, Kazutaka; Yoshida, Fumiaki; Hirata, Masayuki; Suzuki, Takafumi

2017-01-01

Electrocorticogram (ECoG) has great potential as a source signal, especially for clinical BMI. Until recently, ECoG electrodes were commonly used for identifying epileptogenic foci in clinical situations, and such electrodes were low-density and large. Increasing the number and density of recording channels could enable the collection of richer motor/sensory information, and may enhance the precision of decoding and increase opportunities for controlling external devices. Several reports have aimed to increase the number and density of channels. However, few studies have discussed the actual validity of high-density ECoG arrays. In this study, we developed novel high-density flexible ECoG arrays and conducted decoding analyses with monkey somatosensory evoked potentials (SEPs). Using MEMS technology, we made 96-channel Parylene electrode arrays with an inter-electrode distance of 700 μm and recording site area of 350 μm 2 . The arrays were mainly placed onto the finger representation area in the somatosensory cortex of the macaque, and partially inserted into the central sulcus. With electrical finger stimulation, we successfully recorded and visualized finger SEPs with a high spatiotemporal resolution. We conducted offline analyses in which the stimulated fingers and intensity were predicted from recorded SEPs using a support vector machine. We obtained the following results: (1) Very high accuracy (~98%) was achieved with just a short segment of data (~15 ms from stimulus onset). (2) High accuracy (~96%) was achieved even when only a single channel was used. This result indicated placement optimality for decoding. (3) Higher channel counts generally improved prediction accuracy, but the efficacy was small for predictions with feature vectors that included time-series information. These results suggest that ECoG signals with high spatiotemporal resolution could enable greater decoding precision or external device control.

High Spatiotemporal Resolution ECoG Recording of Somatosensory Evoked Potentials with Flexible Micro-Electrode Arrays

PubMed Central

Kaiju, Taro; Doi, Keiichi; Yokota, Masashi; Watanabe, Kei; Inoue, Masato; Ando, Hiroshi; Takahashi, Kazutaka; Yoshida, Fumiaki; Hirata, Masayuki; Suzuki, Takafumi

2017-01-01

Electrocorticogram (ECoG) has great potential as a source signal, especially for clinical BMI. Until recently, ECoG electrodes were commonly used for identifying epileptogenic foci in clinical situations, and such electrodes were low-density and large. Increasing the number and density of recording channels could enable the collection of richer motor/sensory information, and may enhance the precision of decoding and increase opportunities for controlling external devices. Several reports have aimed to increase the number and density of channels. However, few studies have discussed the actual validity of high-density ECoG arrays. In this study, we developed novel high-density flexible ECoG arrays and conducted decoding analyses with monkey somatosensory evoked potentials (SEPs). Using MEMS technology, we made 96-channel Parylene electrode arrays with an inter-electrode distance of 700 μm and recording site area of 350 μm2. The arrays were mainly placed onto the finger representation area in the somatosensory cortex of the macaque, and partially inserted into the central sulcus. With electrical finger stimulation, we successfully recorded and visualized finger SEPs with a high spatiotemporal resolution. We conducted offline analyses in which the stimulated fingers and intensity were predicted from recorded SEPs using a support vector machine. We obtained the following results: (1) Very high accuracy (~98%) was achieved with just a short segment of data (~15 ms from stimulus onset). (2) High accuracy (~96%) was achieved even when only a single channel was used. This result indicated placement optimality for decoding. (3) Higher channel counts generally improved prediction accuracy, but the efficacy was small for predictions with feature vectors that included time-series information. These results suggest that ECoG signals with high spatiotemporal resolution could enable greater decoding precision or external device control. PMID:28442997

Decoding flexion of individual fingers using electrocorticographic signals in humans

NASA Astrophysics Data System (ADS)

Kubánek, J.; Miller, K. J.; Ojemann, J. G.; Wolpaw, J. R.; Schalk, G.

2009-12-01

Brain signals can provide the basis for a non-muscular communication and control system, a brain-computer interface (BCI), for people with motor disabilities. A common approach to creating BCI devices is to decode kinematic parameters of movements using signals recorded by intracortical microelectrodes. Recent studies have shown that kinematic parameters of hand movements can also be accurately decoded from signals recorded by electrodes placed on the surface of the brain (electrocorticography (ECoG)). In the present study, we extend these results by demonstrating that it is also possible to decode the time course of the flexion of individual fingers using ECoG signals in humans, and by showing that these flexion time courses are highly specific to the moving finger. These results provide additional support for the hypothesis that ECoG could be the basis for powerful clinically practical BCI systems, and also indicate that ECoG is useful for studying cortical dynamics related to motor function.

Neuroprosthetic limb control with electrocorticography: approaches and challenges.

PubMed

Thakor, Nitish V; Fifer, Matthew S; Hotson, Guy; Benz, Heather L; Newman, Geoffrey I; Milsap, Griffin W; Crone, Nathan E

2014-01-01

Advanced upper limb prosthetics, such as the Johns Hopkins Applied Physics Lab Modular Prosthetic Limb (MPL), are now available for research and preliminary clinical applications. Research attention has shifted to developing means of controlling these prostheses. Penetrating microelectrode arrays are often used in animal and human models to decode action potentials for cortical control. These arrays may suffer signal loss over the long-term and therefore should not be the only implant type investigated for chronic BMI use. Electrocorticographic (ECoG) signals from electrodes on the cortical surface may provide more stable long-term recordings. Several studies have demonstrated ECoG's potential for decoding cortical activity. As a result, clinical studies are investigating ECoG encoding of limb movement, as well as its use for interfacing with and controlling advanced prosthetic arms. This overview presents the technical state of the art in the use of ECoG in controlling prostheses. Technical limitations of the current approach and future directions are also presented.

Joint Spatial-Spectral Feature Space Clustering for Speech Activity Detection from ECoG Signals

PubMed Central

Kanas, Vasileios G.; Mporas, Iosif; Benz, Heather L.; Sgarbas, Kyriakos N.; Bezerianos, Anastasios; Crone, Nathan E.

2014-01-01

Brain machine interfaces for speech restoration have been extensively studied for more than two decades. The success of such a system will depend in part on selecting the best brain recording sites and signal features corresponding to speech production. The purpose of this study was to detect speech activity automatically from electrocorticographic signals based on joint spatial-frequency clustering of the ECoG feature space. For this study, the ECoG signals were recorded while a subject performed two different syllable repetition tasks. We found that the optimal frequency resolution to detect speech activity from ECoG signals was 8 Hz, achieving 98.8% accuracy by employing support vector machines (SVM) as a classifier. We also defined the cortical areas that held the most information about the discrimination of speech and non-speech time intervals. Additionally, the results shed light on the distinct cortical areas associated with the two syllable repetition tasks and may contribute to the development of portable ECoG-based communication. PMID:24658248

Effects of a Self-Exercise Program on Activities of Daily Living in Patients After Acute Stroke: A Propensity Score Analysis Based on the Japan Association of Rehabilitation Database.

PubMed

Shiraishi, Nariaki; Suzuki, Yusuke; Matsumoto, Daisuke; Jeong, Seungwon; Sugiyama, Motoya; Kondo, Katsunori

2017-03-01

To investigate whether self-exercise programs for patients after stroke contribute to improved activities of daily living (ADL) at hospital discharge. Retrospective, observational, propensity score (PS)-matched case-control study. General hospitals. Participants included patients after stroke (N=1560) hospitalized between January 3, 2006, and December 26, 2012, satisfying the following criteria: (1) data on age, sex, duration from stroke to hospital admission, length of stay, FIM score, modified Rankin Scale (mRS) score, Glasgow Coma Scale score, Japan Stroke Scale score, and self-exercise program participation were available; and (2) admitted within 7 days after stroke onset, length of stay was between 7 and 60 days, prestroke mRS score was ≤2, and not discharged because of FIM or mRS exacerbation. A total of 780 PS-matched pairs were selected for each of the self-exercise program and no-self-exercise program groups. Self-exercise program participation. At discharge, FIM motor score, FIM cognitive score, FIM motor score gain (discharge value - admission value), FIM motor score gain rate (gain/length of stay), a binary variable divided by the median FIM motor score gain rate (high efficiency or no-high efficiency), and mRS score. Patients were classified into a self-exercise program (n=780) or a no-self-exercise program (n=780) group. After matching, there were no significant between-group differences, except motor system variables. The receiver operating characteristic curve for PS had an area under the curve value of .71 with a 95% confidence interval of .68 to .73, and the model was believed to have a relatively favorable fit. A logistic regression analysis of PS-matched pairs suggested that the self-exercise program was effective, with an overall odds ratio for ADL (high efficiency or no-high efficiency) of 2.2 (95% confidence ratio, 1.75-2.70). SEPs may contribute to improving ADL. Copyright © 2016 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

Matching on the Disease Risk Score in Comparative Effectiveness Research of New Treatments

PubMed Central

Wyss, Richard; Ellis, Alan R.; Brookhart, M. Alan; Funk, Michele Jonsson; Girman, Cynthia J.; Simpson, Ross J.; Stürmer, Til

2016-01-01

Purpose We use simulations and an empirical example to evaluate the performance of disease risk score (DRS) matching compared with propensity score (PS) matching when controlling large numbers of covariates in settings involving newly introduced treatments. Methods We simulated a dichotomous treatment, a dichotomous outcome, and 100 baseline covariates that included both continuous and dichotomous random variables. For the empirical example, we evaluated the comparative effectiveness of dabigatran versus warfarin in preventing combined ischemic stroke and all-cause mortality. We matched treatment groups on a historically estimated DRS and again on the PS. We controlled for a high-dimensional set of covariates using 20% and 1% samples of Medicare claims data from October 2010 through December 2012. Results In simulations, matching on the DRS versus the PS generally yielded matches for more treated individuals and improved precision of the effect estimate. For the empirical example, PS and DRS matching in the 20% sample resulted in similar hazard ratios (0.88 and 0.87) and standard errors (0.04 for both methods). In the 1% sample, PS matching resulted in matches for only 92.0% of the treated population and a hazard ratio and standard error of 0.89 and 0.19, respectively, while DRS matching resulted in matches for 98.5% and a hazard ratio and standard error of 0.85 and 0.16, respectively. Conclusions When PS distributions are separated, DRS matching can improve the precision of effect estimates and allow researchers to evaluate the treatment effect in a larger proportion of the treated population. However, accurately modeling the DRS can be challenging compared with the PS. PMID:26112690

Matching on the disease risk score in comparative effectiveness research of new treatments.

PubMed

Wyss, Richard; Ellis, Alan R; Brookhart, M Alan; Jonsson Funk, Michele; Girman, Cynthia J; Simpson, Ross J; Stürmer, Til

2015-09-01

We use simulations and an empirical example to evaluate the performance of disease risk score (DRS) matching compared with propensity score (PS) matching when controlling large numbers of covariates in settings involving newly introduced treatments. We simulated a dichotomous treatment, a dichotomous outcome, and 100 baseline covariates that included both continuous and dichotomous random variables. For the empirical example, we evaluated the comparative effectiveness of dabigatran versus warfarin in preventing combined ischemic stroke and all-cause mortality. We matched treatment groups on a historically estimated DRS and again on the PS. We controlled for a high-dimensional set of covariates using 20% and 1% samples of Medicare claims data from October 2010 through December 2012. In simulations, matching on the DRS versus the PS generally yielded matches for more treated individuals and improved precision of the effect estimate. For the empirical example, PS and DRS matching in the 20% sample resulted in similar hazard ratios (0.88 and 0.87) and standard errors (0.04 for both methods). In the 1% sample, PS matching resulted in matches for only 92.0% of the treated population and a hazard ratio and standard error of 0.89 and 0.19, respectively, while DRS matching resulted in matches for 98.5% and a hazard ratio and standard error of 0.85 and 0.16, respectively. When PS distributions are separated, DRS matching can improve the precision of effect estimates and allow researchers to evaluate the treatment effect in a larger proportion of the treated population. However, accurately modeling the DRS can be challenging compared with the PS. Copyright © 2015 John Wiley & Sons, Ltd.

Systematic review, network meta-analysis and economic evaluation of biological therapy for the management of active psoriatic arthritis.

PubMed

Cawson, Matthew Richard; Mitchell, Stephen Andrew; Knight, Chris; Wildey, Henry; Spurden, Dean; Bird, Alex; Orme, Michelle Elaine

2014-01-20

An updated economic evaluation was conducted to compare the cost-effectiveness of the four tumour necrosis factor (TNF)-α inhibitors adalimumab, etanercept, golimumab and infliximab in active, progressive psoriatic arthritis (PsA) where response to standard treatment has been inadequate. A systematic review was conducted to identify relevant, recently published studies and the new trial data were synthesised, via a Bayesian network meta-analysis (NMA), to estimate the relative efficacy of the TNF-α inhibitors in terms of Psoriatic Arthritis Response Criteria (PsARC) response, Health Assessment Questionnaire (HAQ) scores and Psoriasis Area and Severity Index (PASI). A previously developed economic model was updated with the new meta-analysis results and current cost data. The model was adapted to delineate patients by PASI 50%, 75% and 90% response rates to differentiate between psoriasis outcomes. All four licensed TNF-α inhibitors were significantly more effective than placebo in achieving PsARC response in patients with active PsA. Adalimumab, etanercept and infliximab were significantly more effective than placebo in improving HAQ scores in patients who had achieved a PsARC response and in improving HAQ scores in PsARC non-responders. In an analysis using 1,000 model simulations, on average etanercept was the most cost-effective treatment and, at the National Institute for Health and Care Excellence willingness-to-pay threshold of between £20,000 to £30,000, etanercept is the preferred option. The economic analysis agrees with the conclusions from the previous models, in that biologics are shown to be cost-effective for treating patients with active PsA compared with the conventional management strategy. In particular, etanercept is cost-effective compared with the other biologic treatments.

Cosmetic Outcomes and Quality of Life in Thai Women Post Breast Conserving Therapy for Breast Cancer.

PubMed

Thanarpan, Peerawong; Somrit, Mahattanobon; Rungarun, Jiratrachu; Paytai, Rordlamool; Duangjai, Sangtawan; Chanon, Kongkamol; Puttisak, Puttawibul

2015-01-01

To evaluate the correlation between cosmetic outcome (CO), body image, and quality of life in post breast-conserving therapy (BCT) women. This cross-sectional study concerned one-year post-completed BCT Thai women. The data included subjective and objective CO with a questionnaire covering demographic and clinical data, anti-hormonal treatment status, Eastern Cooperative Oncology Group (ECOG) performance status, Self-Reported Cosmetic Outcomes (SRCO), Self-Reported Breast Symmetry (SRBS), Body Image Scale (BIS), and the Functional Assessment of Cancer Therapy with Breast Cancer subscale (FACT-B). Participants had breast photographs taken for the evaluation of objective cosmetic outcome (OCO) after breast cancer conservation treatment. The relationship between CO and FACT-B was tested using Spearman's rank correlation Results: A total 127 participants volunteered for the study. The participant characteristics were age 52(±9), Buddhist 87%, married 65%, body mass index 25.0(±4.6), breast cup size A-C 91%, college educated 60%, employed 66%, ECOG 0-1 95%, tumor size less than or equal to 2 cm 55%, no lymph node metastasis 98%, and taking tamoxifen 57%. Two percent of the participants regretted their decision to undergo BCT. The SRCO was excellent in 2%, good in 68%, fair in 30%, and poor in 0%. For SRBS, rates were 17%, 58%, 24% and 1% for excellent, good, fair and poor cosmetic outcomes, respectively. The BCCT scores were excellent 24%, good 39%, fair 32%, and poor 6%. The median total QOL score of the participants was 130 (93-144). There was no significant correlation between CO and FACT-B scores. The significance of CO for FACT-B in Thai women with breast cancer could not be assessed in detail because of a very low level of correlation. The results may be due to the effects of cultural background.

Prospective Randomized Phase II Parallel Study of Vinorelbine Maintenance Therapy versus Best Supportive Care in Advanced Non-Small Cell Lung Cancer.

PubMed

Khosravi, Adnan; Esfahani-Monfared, Zahra; Seifi, Sharareh; Khodadad, Kian

2017-01-01

Maintenance strategy has been used to improve survival in non-small cell lung cancer (NSCLC). We investigated whether switch maintenance therapy with vinorelbine improved progression free survival (PFS) after first-line chemotherapy with gemcitabine plus carboplatin. In this single blind, parallel, phase 2, randomized trial, patients with NSCLC pathology, age >18 years, Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0-2, and advanced stage (IIIB and IV) were treated with up to 6 cycles of gemcitabine 1250 mg/m 2 (day 1 and 8) plus carboplatin AUC 5 (day 1) every 3 weeks. Patients who did not show progression after first-line chemotherapy were randomly assigned to receive switch maintenance with vinorelbine (25 mg/m 2 , day 1, 15) or the best supportive care until disease progression. A total of 100 patients were registered, of whom 34 had a non-progressive response to first-line chemotherapy and randomly received maintenance vinorelbine (n=19) or best supportive care (n=15). The hazard ratio of PFS in the vinorelbine group relative to the best supportive care group was 1.097 (95% confidence interval = 0.479-2.510; P-value =0.827). There was no significant difference between the overall survival for the two groups (P=0.068). Switch maintenance strategies are beneficial, but defining the right candidates for treatment is a problem. Moreover, the trial designs do not always reflect the real-world considerations. Switch maintenance therapy with vinorelbine, though had tolerable toxicity, did not improve PFS in patients with NSCLC. Therefore, other agents should be considered in this setting.

Neural Correlates of Visual–Spatial Attention in Electrocorticographic Signals in Humans

PubMed Central

Gunduz, Aysegul; Brunner, Peter; Daitch, Amy; Leuthardt, Eric C.; Ritaccio, Anthony L.; Pesaran, Bijan; Schalk, Gerwin

2011-01-01

Attention is a cognitive selection mechanism that allocates the limited processing resources of the brain to the sensory streams most relevant to our immediate goals, thereby enhancing responsiveness and behavioral performance. The underlying neural mechanisms of orienting attention are distributed across a widespread cortical network. While aspects of this network have been extensively studied, details about the electrophysiological dynamics of this network are scarce. In this study, we investigated attentional networks using electrocorticographic (ECoG) recordings from the surface of the brain, which combine broad spatial coverage with high temporal resolution, in five human subjects. ECoG was recorded when subjects covertly attended to a spatial location and responded to contrast changes in the presence of distractors in a modified Posner cueing task. ECoG amplitudes in the alpha, beta, and gamma bands identified neural changes associated with covert attention and motor preparation/execution in the different stages of the task. The results show that attentional engagement was primarily associated with ECoG activity in the visual, prefrontal, premotor, and parietal cortices. Motor preparation/execution was associated with ECoG activity in premotor/sensorimotor cortices. In summary, our results illustrate rich and distributed cortical dynamics that are associated with orienting attention and the subsequent motor preparation and execution. These findings are largely consistent with and expand on primate studies using intracortical recordings and human functional neuroimaging studies. PMID:22046153

Nursing Student Self-efficacy in Psychomotor Skills: Findings From a Validation, Longitudinal, and Correlational Study.

PubMed

Bulfone, Giampiera; Fida, Roberta; Ghezzi, Valerio; Macale, Loreana; Sili, Alessandro; Alvaro, Rosaria; Palese, Alvisa

Student perceptions of self-efficacy (SE) prevent stress and burnout and improve engagement in nursing education, thus increasing learning outcomes. The study aims were to (1) validate a scale measuring nursing SE in psychomotor skills (NSE-PS), (2) describe changes in NSE-PS over time, and (3) explore NSE-PS correlations with burnout and engagement. A total of 1117 nursing students participated. A significant increase in the NSE-PS scores over the years has emerged; in addition, all NSE-PS dimensions were correlated negatively with burnout and positively with engagement.

The search for causal inferences: using propensity scores post hoc to reduce estimation error with nonexperimental research.

PubMed

Tumlinson, Samuel E; Sass, Daniel A; Cano, Stephanie M

2014-03-01

While experimental designs are regarded as the gold standard for establishing causal relationships, such designs are usually impractical owing to common methodological limitations. The objective of this article is to illustrate how propensity score matching (PSM) and using propensity scores (PS) as a covariate are viable alternatives to reduce estimation error when experimental designs cannot be implemented. To mimic common pediatric research practices, data from 140 simulated participants were used to resemble an experimental and nonexperimental design that assessed the effect of treatment status on participant weight loss for diabetes. Pretreatment participant characteristics (age, gender, physical activity, etc.) were then used to generate PS for use in the various statistical approaches. Results demonstrate how PSM and using the PS as a covariate can be used to reduce estimation error and improve statistical inferences. References for issues related to the implementation of these procedures are provided to assist researchers.

A novel neural prosthesis providing long-term electrocorticography recording and cortical stimulation for epilepsy and brain-computer interface.

PubMed

Romanelli, Pantaleo; Piangerelli, Marco; Ratel, David; Gaude, Christophe; Costecalde, Thomas; Puttilli, Cosimo; Picciafuoco, Mauro; Benabid, Alim; Torres, Napoleon

2018-05-11

OBJECTIVE Wireless technology is a novel tool for the transmission of cortical signals. Wireless electrocorticography (ECoG) aims to improve the safety and diagnostic gain of procedures requiring invasive localization of seizure foci and also to provide long-term recording of brain activity for brain-computer interfaces (BCIs). However, no wireless devices aimed at these clinical applications are currently available. The authors present the application of a fully implantable and externally rechargeable neural prosthesis providing wireless ECoG recording and direct cortical stimulation (DCS). Prolonged wireless ECoG monitoring was tested in nonhuman primates by using a custom-made device (the ECoG implantable wireless 16-electrode [ECOGIW-16E] device) containing a 16-contact subdural grid. This is a preliminary step toward large-scale, long-term wireless ECoG recording in humans. METHODS The authors implanted the ECOGIW-16E device over the left sensorimotor cortex of a nonhuman primate ( Macaca fascicularis), recording ECoG signals over a time span of 6 months. Daily electrode impedances were measured, aiming to maintain the impedance values below a threshold of 100 KΩ. Brain mapping was obtained through wireless cortical stimulation at fixed intervals (1, 3, and 6 months). After 6 months, the device was removed. The authors analyzed cortical tissues by using conventional histological and immunohistological investigation to assess whether there was evidence of damage after the long-term implantation of the grid. RESULTS The implant was well tolerated; no neurological or behavioral consequences were reported in the monkey, which resumed his normal activities within a few hours of the procedure. The signal quality of wireless ECoG remained excellent over the 6-month observation period. Impedance values remained well below the threshold value; the average impedance per contact remains approximately 40 KΩ. Wireless cortical stimulation induced movements of the upper and lower limbs, and elicited fine movements of the digits as well. After the monkey was euthanized, the grid was found to be encapsulated by a newly formed dural sheet. The grid removal was performed easily, and no direct adhesions of the grid to the cortex were found. Conventional histological studies showed no cortical damage in the brain region covered by the grid, except for a single microscopic spot of cortical necrosis (not visible to the naked eye) in a region that had undergone repeated procedures of electrical stimulation. Immunohistological studies of the cortex underlying the grid showed a mild inflammatory process. CONCLUSIONS This preliminary experience in a nonhuman primate shows that a wireless neuroprosthesis, with related long-term ECoG recording (up to 6 months) and multiple DCSs, was tolerated without sequelae. The authors predict that epilepsy surgery could realize great benefit from this novel prosthesis, providing an extended time span for ECoG recording.

Characterization of clinical photosensitivity in cutaneous lupus erythematosus.

PubMed

Foering, Kristen; Chang, Aileen Y; Piette, Evan W; Cucchiara, Andrew; Okawa, Joyce; Werth, Victoria P

2013-08-01

Photosensitivity (PS) in lupus erythematosus (LE) is frequently determined by patient report. We sought to characterize self-reported PS in cutaneous LE (CLE). The PS survey was used to classify subject responses into 5 phenotypes: direct sun-induced CLE flare (directCLE); general exacerbation of CLE (genCLE); polymorphic light eruption-like reactions (genSkin); general pruritus/paresthesias (genRxn); and sun-induced systemic symptoms (genSys). In all, 91 subjects with CLE alone or with CLE and systemic LE were interviewed. In all, 81% ascribed to 1 or more PS phenotypes. CLE-specific reactions (direct sun-induced CLE flare or general exacerbation of CLE) were reported by 86% of photosensitive subjects. Higher CLE disease activity (measured by CLE Disease Area and Severity Index activity scores) was suggestive of direct sun-induced CLE flare reactions (P = .09). In all, 60% of photosensitive subjects described CLE-nonspecific reactions: polymorphic light eruption-like rash and general pruritus/paresthesias. These phenotypes often co-occurred with CLE-specific reactions and were predicted by more systemic disease activity as measured by Physicians Global Assessment (PGA) scores in regression analyses (genSkin, P = .02) and (genRxn, P = .05). In all, 36% of subjects reported systemic reactions and higher PGA scores were predictive of the sun-induced systemic symptoms phenotype (P = .02); a diagnosis of systemic LE was not (P = .14). PS was inferred from patient report and not directly observed. Characterization of self-reported PS in LE reveals that patients experience combinations of CLE-specific, CLE-nonspecific, and systemic reactions to sunlight. Sun-induced CLE flares are associated with more active CLE disease. Polymorphic light eruption-like, generalized pruritus/paresthesias, and systemic reactions are associated with more active systemic disease. Recognition of PS phenotypes will permit improved definitions of clinical PS and allow for more precise investigation into its pathophysiology. Copyright © 2013 American Academy of Dermatology, Inc. Published by Mosby, Inc. All rights reserved.

Functional Outcomes of a New Mobile-Bearing Ultra-Congruent TKA System: Comparison With the Posterior Stabilized System.

PubMed

Machhindra, Morey Vivek; Kang, Jong Yeal; Kang, Yeon Gwi; Chowdhry, Madhav; Kim, Tae Kyun

2015-12-01

We determined whether a new mobile-bearing ultra-congruent (UC) TKA system provides better functional outcomes than an established posterior-stabilized (PS) prosthesis. The functional outcomes (motion arc, AKS scores, WOMAC Index, and SForm-36 scores evaluated at 1 and 2 years postoperatively), satisfaction and incidences of adverse events were compared between the knees implanted with mobile-bearing UC prosthesis (n=103) and the mobile-bearing PS prosthesis (n=99). At 2 years, mobile-bearing UC TKAs showed similar functional outcomes and satisfaction, but smaller motion arc compared to mobile-bearing PS TKAs (126° vs. 131°). There were no differences in the incidence of adverse events. Mobile-bearing UC prosthesis can be considered a safe and viable alternative to the PS design, with an expectation of smaller postoperative maximum flexion. Copyright © 2015 Elsevier Inc. All rights reserved.

Estrogen- and progesterone-receptor status in ECOG 2197: comparison of immunohistochemistry by local and central laboratories and quantitative reverse transcription polymerase chain reaction by central laboratory.

PubMed

Badve, Sunil S; Baehner, Frederick L; Gray, Robert P; Childs, Barrett H; Maddala, Tara; Liu, Mei-Lan; Rowley, Steve C; Shak, Steven; Perez, Edith A; Perez, Edith D; Shulman, Lawrence J; Martino, Silvana; Davidson, Nancy E; Sledge, George W; Goldstein, Lori J; Sparano, Joseph A

2008-05-20

Central and local laboratory concordance for hormone receptor measurement is therapeutically important. This study compares estrogen receptor (ER) and progesterone receptor (PR) measured by local laboratory immunohistochemistry (IHC), central IHC, and central reverse-transcriptase polymerase chain reaction (RT-PCR) using a proprietary 21-gene assay. A case-control sample of 776 breast cancer patients from Eastern Cooperative Oncology Group (ECOG) study E2197 was evaluated. Central IHC Allred score for ER and PR was obtained using tissue microarrays and 1D5 ER antibody and 636 PR antibody. Quantitative RT-PCR for ER and PR in whole sections was performed using the 21-gene assay. For ER, the concordance between local and central IHC was 90% (95% CI, 88% to 92%), between local IHC and central RT-PCR was 91% (95% CI, 89% to 93%), and between central IHC and central RT-PCR was 93% (95% CI, 91% to 95%). For PR, the concordance between local IHC and central IHC was 84% (95% CI, 82% to 87%), between local IHC and central RT-PCR was 88% (95% CI, 85% to 90%), and between central IHC and central RT-PCR was 90% (95% CI, 88% to 92%). Although concordance was high, IHC ER-negative cases that were RT-PCR positive were more common than IHC ER-positive cases that were RT-PCR negative. In ER-positive patients, ER expression by central IHC Allred score was marginally associated with recurrence (P = .091), and ER expression by central RT-PCR was significantly associated with recurrence (P = .014). However, recurrence score, which incorporates additional genes/pathways, was a highly significant predictor of recurrence (P < .0001). There is a high degree of concordance among local IHC, central IHC, and central RT-PCR by the proprietary gene assay for ER and PR status. Although ER expression is marginally associated with relapse in ER-positive patients treated with chemohormonal therapy, recurrence score is a highly significant predictor of recurrence.

psRNATarget: a plant small RNA target analysis server (2017 release).

PubMed

Dai, Xinbin; Zhuang, Zhaohong; Zhao, Patrick Xuechun

2018-04-30

Plant regulatory small RNAs (sRNAs), which include most microRNAs (miRNAs) and a subset of small interfering RNAs (siRNAs), such as the phased siRNAs (phasiRNAs), play important roles in regulating gene expression. Although generated from genetically distinct biogenesis pathways, these regulatory sRNAs share the same mechanisms for post-translational gene silencing and translational inhibition. psRNATarget was developed to identify plant sRNA targets by (i) analyzing complementary matching between the sRNA sequence and target mRNA sequence using a predefined scoring schema and (ii) by evaluating target site accessibility. This update enhances its analytical performance by developing a new scoring schema that is capable of discovering miRNA-mRNA interactions at higher 'recall rates' without significantly increasing total prediction output. The scoring procedure is customizable for the users to search both canonical and non-canonical targets. This update also enables transmitting and analyzing 'big' data empowered by (a) the implementation of multi-threading chunked file uploading, which can be paused and resumed, using HTML5 APIs and (b) the allocation of significantly more computing nodes to its back-end Linux cluster. The updated psRNATarget server has clear, compelling and user-friendly interfaces that enhance user experiences and present data clearly and concisely. The psRNATarget is freely available at http://plantgrn.noble.org/psRNATarget/.

An international, multicenter phase II trial of bortezomib in patients with hepatocellular carcinoma.

PubMed

Kim, George P; Mahoney, Michelle R; Szydlo, Daniel; Mok, Tony S K; Marshke, Robert; Holen, Kyle; Picus, Joel; Boyer, Michael; Pitot, Henry C; Rubin, Joseph; Philip, Philip A; Nowak, Anna; Wright, John J; Erlichman, Charles

2012-02-01

Bortezomib (PS-341, VELCADE®) is a selective inhibitor of the 26S proteasome, an integral component of the ubiquitin-proteasome pathway. This phase II study evaluated the activity and tolerability of bortezomib in unresectable hepatocellular carcinoma (HCC) patients. The primary endpoint was confirmed tumor response rate (RR) with secondary endpoints including duration of response, time to disease progression, survival and toxicity. Treatment consisted of bortezomib, 1.3 mg/m2 IV bolus on days 1, 4, 8, and 11 of each 21-day treatment cycle. Eligibility included: no prior systemic chemotherapy, ECOG PS 0-2, Child-Pugh A or B, preserved hematologic, hepatic and neurologic function; prior liver-directed therapy was permitted. Thirty-five patients enrolled and received a median of 2 cycles of treatment (range 1-12). Overall, 24 and 4 patients had a maximum severity of grade 3 and 4 adverse events (AEs), respectively. No treatment related deaths occurred. Only thrombocytopenia (11%) was seen in greater than 10% of patients. One patient achieved a partial response, lasting 13 weeks during treatment and progressed 11.6 months later; two patients received treatment for greater than 6 months. Median time-to-progression was 1.6 months and median survival was 6.0 months. This international, multicenter trial evaluated bortezomib as monotherapy in unresectable HCC patients. And, despite the lack of significant activity, this report serves as a baseline clinical experience for the development of future dual biologic approaches including bortezomib.

An international, multicenter phase II trial of bortezomib in patients with hepatocellular carcinoma

PubMed Central

Kim, George P.; Mahoney, Michelle R.; Szydlo, Daniel; Mok, Tony S. K.; Marshke, Robert; Holen, Kyle; Picus, Joel; Boyer, Michael; Pitot, Henry C.; Rubin, Joseph; Philip, Philip A.; Nowak, Anna; Wright, John J.; Erlichman, Charles

2013-01-01

Summary Background and Rationale Bortezomib (PS-341, VELCADE®) is a selective inhibitor of the 26S proteasome, an integral component of the ubiquitinproteasome pathway. This phase II study evaluated the activity and tolerability of bortezomib in unresectable hepatocellular carcinoma (HCC) patients. Methods The primary endpoint was confirmed tumor response rate (RR) with secondary endpoints including duration of response, time to disease progression, survival and toxicity. Treatment consisted of bortezomib, 1.3 mg/m2 IV bolus on days 1, 4, 8, and 11 of each 21-day treatment cycle. Eligibility included: no prior systemic chemotherapy, ECOG PS 0-2, Child-Pugh A or B, preserved hematologic, hepatic and neurologic function; prior liver-directed therapy was permitted. Results Thirty-five patients enrolled and received a median of 2 cycles of treatment (range 1–12). Overall, 24 and 4 patients had a maximum severity of grade 3 and 4 adverse events (AEs), respectively. No treatment related deaths occurred. Only thrombocytopenia (11%) was seen in greater than 10% of patients. One patient achieved a partial response, lasting 13 weeks during treatment and progressed 11.6 months later; two patients received treatment for greater than 6 months. Median time-to-progression was 1.6 months and median survival was 6.0 months. Conclusions This international, multicenter trial evaluated bortezomib as monotherapy in unresectable HCC patients. And, despite the lack of significant activity, this report serves as a baseline clinical experience for the development of future dual biologic approaches including bortezomib. PMID:20839030

Associations between emotion regulation difficulties, eating disorder symptoms, non-suicidal self-injury, and suicide attempts in a heterogeneous eating disorder sample.

PubMed

Pisetsky, Emily M; Haynos, Ann F; Lavender, Jason M; Crow, Scott J; Peterson, Carol B

2017-02-01

This study examined the associations between specific dimensions of emotion dysregulation and eating disorder (ED) symptoms and behaviors, non-suicidal self-injury (NSSI), and suicide attempts in a heterogeneous ED sample. Participants (N=110) completed the Difficulties in Emotion Regulation Scale (DERS), the Eating Disorder Examination Questionnaire (EDE-Q), and self-reported the presence of lifetime NSSI and a lifetime suicide attempt. The EDE-Q global score, a primarily cognitive measure of ED symptoms, was significantly positively correlated with DERS strategies, clarity, and awareness subscale scores and DERS total score (ps<0.01). Only the strategies subscale was uniquely positively associated with EDE-Q global score in a multivariate regression analysis. There was no association between the frequency of binge eating or frequency of driven exercise and any of the DERS subscale scores or total score (ps>0.01). Frequency of purging was significantly, positively associated with DERS impulse subscale score and total score (p<0.01). None of the DERS subscale scores were significantly different between those with and without NSSI or between those with and without a lifetime suicide attempt (ps>0.01). Findings indicate that in a heterogeneous ED sample, emotion regulation deficits are more strongly associated with cognitively-oriented symptoms of EDs than behavioral symptoms such as a binge eating, purging, driven exercise, NSSI, or suicide attempts. Copyright © 2016 Elsevier Inc. All rights reserved.

Potential Pitfalls of Reporting and Bias in Observational Studies With Propensity Score Analysis Assessing a Surgical Procedure: A Methodological Systematic Review.

PubMed

Lonjon, Guillaume; Porcher, Raphael; Ergina, Patrick; Fouet, Mathilde; Boutron, Isabelle

2017-05-01

To describe the evolution of the use and reporting of propensity score (PS) analysis in observational studies assessing a surgical procedure. Assessing surgery in randomized controlled trials raises several challenges. Observational studies with PS analysis are a robust alternative for comparative effectiveness research. In this methodological systematic review, we identified all PubMed reports of observational studies with PS analysis that evaluated a surgical procedure and described the evolution of their use over time. Then, we selected a sample of articles published from August 2013 to July 2014 and systematically appraised the quality of reporting and potential bias of the PS analysis used. We selected 652 reports of observational studies with PS analysis. The publications increased over time, from 1 report in 1987 to 198 in 2013. Among the 129 reports assessed, 20% (n = 24) did not detail the covariates included in the PS and 77% (n = 100) did not report a justification for including these covariates in the PS. The rate of missing data for potential covariates was reported in 9% of articles. When a crossover by conversion was possible, only 14% of reports (n = 12) mentioned this issue. For matched analysis, 10% of articles reported all 4 key elements that allow for reproducibility of a PS-matched analysis (matching ratio, method to choose the nearest neighbors, replacement and method for statistical analysis). Observational studies with PS analysis in surgery are increasing in frequency, but specific methodological issues and weaknesses in reporting exist.

Frequency of undiagnosed psoriatic arthritis among psoriasis patients in Australian dermatology practice.

PubMed

Spelman, L; Su, J C; Fernandez-Peñas, P; Varigos, G A; Cooper, A J; Baker, C S; Lee, M; Ring, J M; Thirunavukkarasu, K

2015-11-01

Psoriatic arthritis commonly develops in psoriasis patients and, if undiagnosed, can lead to potentially avoidable joint damage and an increased risk of comorbidity and mortality. Increased awareness of PsA symptoms among dermatologists provides an opportunity for earlier diagnosis, more timely therapy and prevention of disability. To provide Australian epidemiological data on the frequency of undiagnosed PsA among psoriasis patients in dermatology practice, and to investigate the impact of psoriasis on quality of life and work productivity. Nine tertiary centre dermatology practices enrolled patients presenting with plaque psoriasis and no prior rheumatologist-confirmed PsA diagnosis. Patients were screened using the Psoriatic Arthritis Screening and Evaluation (PASE) questionnaire and were referred to a rheumatologist for assessment of PsA status using CASPAR criteria if they had a PASE score ≥44. Based on the composite and sequential application of PASE and CASPAR criteria, undiagnosed PsA among psoriasis patients in this study is 9% [95% CI: 6, 12]. The PPV of PASE in this setting is 26% [95% CI: 19, 34]. Nail involvement and chronic large plaque psoriasis were identified as independent positive predictors of PsA, whereas scalp psoriasis was an independent negative predictor of PsA. Patients with moderate-to-severe psoriasis (PASI ≥15) had lower quality of life scores than patients with less severe psoriasis. In this study, the frequency of undiagnosed PsA in Australian dermatology practice was 9% among plaque psoriasis patients with no prior PsA diagnosis. Compared with psoriasis alone, the impact of undiagnosed PsA on health-related quality of life of psoriasis patients is substantial. © 2015 European Academy of Dermatology and Venereology.

Non ictal onset zone: A window to ictal dynamics.

PubMed

Afra, Pegah; Hanrahan, Sara J; Kellis, Spencer Sterling; House, Paul

2017-01-01

The focal and network concepts of epilepsy present different aspects of electroclinical phenomenon of seizures. Here, we present a 23-year-old man undergoing surgical evaluation with left fronto-temporal electrocorticography (ECoG) and microelectrode-array (MEA) in the middle temporal gyrus (MTG). We compare action-potential (AP) and local field potentials (LFP) recorded from MEA with ECoG. Seizure onset in the mesial-temporal lobe was characterized by changes in the pattern of AP-firing without clear changes in LFP or ECoG in MTG. This suggests simultaneous analysis of neuronal activity in differing spatial scales and frequency ranges provide complementary insights into how focal and network neurophysiological activity contribute to ictal activity.

Mental health related determinants of parenting stress among urban mothers of young children – results from a birth-cohort study in Ghana and Côte d’Ivoire

PubMed Central

2014-01-01

Background There are limited data on the parenting stress (PS) levels in sub-Saharan African mothers and on the association between ante- and postnatal depression and anxiety on PS. Methods A longitudinal birth cohort of 577 women from Ghana and Côte d’Ivoire was followed from the 3rd trimester in pregnancy to 2 years postpartum between 2010 and 2013. Depression and anxiety were assessed by the Patient Health Questionnaire depression module (PHQ-9) and the Generalized Anxiety Disorder (GAD-7) at baseline, 3 month, 12 month and 24 month postpartum. PS was measured using the Parenting Stress Index-Short Form (PSI-SF) at 3, 12 and 24 month. The mean total PS score and the subscale scores were compared among depressed vs. non-depressed and among anxious vs. non-anxious mothers at 3, 12 and 24 month postpartum. The proportions of clinical PS (PSI-SF raw score > 90) in depressed vs. non-depressed and anxious vs. non-anxious mothers were also compared. A generalized estimating equation (GEE) approach was used to estimate population-averaged associations between women’s depression/anxiety and PS adjusting for age, child sex, women’s anemia, education, occupation, spouse’s education, and number of sick child visits. Results A total of 577, 531 and 264 women completed the PS assessment at 3 month, 12 month and 24 month postpartum across the two sites and the prevalences of clinical PS at each time point was 33.1%, 24.4% and 14.9% in Ghana and 30.2%, 33.5% and 22.6% in Côte d’Ivoire, respectively. At all three time points, the PS scores were significantly higher among depressed mothers vs. non-depressed mothers. In the multivariate regression analyses, antepartum and postpartum depression were consistently associated with PS after adjusting for other variables. Conclusions Parenting stress is frequent and levels are high compared with previous studies from high-income countries. Antepartum and postpartum depression were both associated with PS, while antepartum and postpartum anxiety were not after adjusting for confounders. More quantitative and qualitative data are needed in sub-Saharan African populations to assess the burden of PS and understand associated mechanisms. Should our findings be replicated, it appears prudent to design and subsequently evaluate intervention strategies. PMID:24884986

Development of an implantable wireless ECoG 128ch recording device for clinical brain machine interface.

PubMed

Matsushita, Kojiro; Hirata, Masayuki; Suzuki, Takafumi; Ando, Hiroshi; Ota, Yuki; Sato, Fumihiro; Morris, Shyne; Yoshida, Takeshi; Matsuki, Hidetoshi; Yoshimine, Toshiki

2013-01-01

Brain Machine Interface (BMI) is a system that assumes user's intention by analyzing user's brain activities and control devices with the assumed intention. It is considered as one of prospective tools to enhance paralyzed patients' quality of life. In our group, we especially focus on ECoG (electro-corti-gram)-BMI, which requires surgery to place electrodes on the cortex. We try to implant all the devices within the patient's head and abdomen and to transmit the data and power wirelessly. Our device consists of 5 parts: (1) High-density multi-electrodes with a 3D shaped sheet fitting to the individual brain surface to effectively record the ECoG signals; (2) A small circuit board with two integrated circuit chips functioning 128 [ch] analogue amplifiers and A/D converters for ECoG signals; (3) A Wifi data communication & control circuit with the target PC; (4) A non-contact power supply transmitting electrical power minimum 400[mW] to the device 20[mm] away. We developed those devices, integrated them, and, investigated the performance.

A Possible Physiological Basis for the Discontinuity of Consciousness

PubMed Central

Pockett, Susan; Brennan, Barry J.; Bold, Gary E. J.; Holmes, Mark D.

2011-01-01

A comparison is made between the frequency of local minima in the analytic power (AP) of intracranial EEG (ECoG) from waking and unconscious human subjects and the frequency of putative frames of consciousness reported in earlier psychological literature. In ECoG from unconscious subjects, the frequency of deep minima in AP is found to be a linear function of bandwidth. In contrast, in ECoG from conscious subjects, the bandwidth/minima-frequency curve saturates or plateaus at minima frequencies similar to the frequencies of previously reported frames of consciousness. This result is consistent with the hypothesis that local minima in AP may act as the shutter in a cinematographic model of consciousness. The fact that artificially generated samples of black noise with power spectra similar to ECoG data give similar results in the analyses above suggests that the discontinuous nature of consciousness is not due to some specifically biological factor, but is simply a consequence of the physical properties of the 1/f (aka power law) oscillations that are widely found in nature. PMID:22203811

Unsupervised Decoding of Long-Term, Naturalistic Human Neural Recordings with Automated Video and Audio Annotations

PubMed Central

Wang, Nancy X. R.; Olson, Jared D.; Ojemann, Jeffrey G.; Rao, Rajesh P. N.; Brunton, Bingni W.

2016-01-01

Fully automated decoding of human activities and intentions from direct neural recordings is a tantalizing challenge in brain-computer interfacing. Implementing Brain Computer Interfaces (BCIs) outside carefully controlled experiments in laboratory settings requires adaptive and scalable strategies with minimal supervision. Here we describe an unsupervised approach to decoding neural states from naturalistic human brain recordings. We analyzed continuous, long-term electrocorticography (ECoG) data recorded over many days from the brain of subjects in a hospital room, with simultaneous audio and video recordings. We discovered coherent clusters in high-dimensional ECoG recordings using hierarchical clustering and automatically annotated them using speech and movement labels extracted from audio and video. To our knowledge, this represents the first time techniques from computer vision and speech processing have been used for natural ECoG decoding. Interpretable behaviors were decoded from ECoG data, including moving, speaking and resting; the results were assessed by comparison with manual annotation. Discovered clusters were projected back onto the brain revealing features consistent with known functional areas, opening the door to automated functional brain mapping in natural settings. PMID:27148018

Low Rate of Intraoperative Seizures During Awake Craniotomy in a Prospective Cohort with 374 Supratentorial Brain Lesions: Electrocorticography Is Not Mandatory.

PubMed

Boetto, Julien; Bertram, Luc; Moulinié, Gérard; Herbet, Guillaume; Moritz-Gasser, Sylvie; Duffau, Hugues

2015-12-01

Awake craniotomy (AC) in brain lesions has allowed an improvement of both oncologic and functional results. However, intraoperative seizures (IOSs) were reported as a cause of failure of AC. Here, we analyze the incidence, risk factors, and consequences of IOSs in a prospective cohort of 374 ACs without electrocorticography (ECoG). We performed a prospective study including all patients who underwent AC for an intra-axial supratentorial cerebral lesion from 2009-2014 in our department. Occurrence of IOS was analyzed with respect to medical and epilepsy history, tumor characteristics, operative technique, and postoperative outcomes. The study comprised 374 patients with a major incidence of low-grade glioma (86%). Most of the patients (83%) had epilepsy history before surgery (20% had intractable seizures). Preoperative mean Karnofsky performance scale (KPS) score was 91. IOSs occurred in 13 patients (3.4%). All IOSs were partial seizures, which quickly resolved by irrigation with cold Ringer lactate. No procedure failed because of IOS, and the rate of aborted AC whatever the cause was nil. Mean stimulation current intensity for cortical and subcortical mapping was 2.25 ± 0.6 mA. Presurgical refractory epilepsy was not associated with a higher incidence of IOS. Three months after surgery, no patients had severe or disabling permanent worsening, even within the IOS group (mean KPS score of 93.7). AC for intra-axial brain lesion can be safely and reproducibly achieved without ECoG, with a low rate of IOS and excellent functional results, even in patients with preoperative intractable epilepsy. Copyright © 2015 Elsevier Inc. All rights reserved.

Preoperative nomogram to predict the likelihood of complications after radical nephroureterectomy.

PubMed

Raman, Jay D; Lin, Yu-Kuan; Shariat, Shahrokh F; Krabbe, Laura-Maria; Margulis, Vitaly; Arnouk, Alex; Lallas, Costas D; Trabulsi, Edouard J; Drouin, Sarah J; Rouprêt, Morgan; Bozzini, Gregory; Colin, Pierre; Peyronnet, Benoit; Bensalah, Karim; Bailey, Kari; Canes, David; Klatte, Tobias

2017-02-01

To construct a nomogram based on preoperative variables to better predict the likelihood of complications occurring within 30 days of radical nephroureterectomy (RNU). The charts of 731 patients undergoing RNU at eight academic medical centres between 2002 and 2014 were reviewed. Preoperative clinical, demographic and comorbidity indices were collected. Complications occurring within 30 days of surgery were graded using the modified Clavien-Dindo scale. Multivariate logistic regression determined the association between preoperative variables and post-RNU complications. A nomogram was created from the reduced multivariate model with internal validation using the bootstrapping technique with 200 repetitions. A total of 408 men and 323 women with a median age of 70 years and a body mass index of 27 kg/m 2 were included. A total of 75% of the cohort was white, 18% had an Eastern Cooperative Oncology Group (ECOG) performance status ≥2, 20% had a Charlson comorbidity index (CCI) score >5 and 50% had baseline chronic kidney disease (CKD) ≥ stage III. Overall, 279 patients (38%) experienced a complication, including 61 events (22%) with Clavien grade ≥ III. A multivariate model identified five variables associated with complications, including patient age, race, ECOG performance status, CKD stage and CCI score. A preoperative nomogram incorporating these risk factors was constructed with an area under curve of 72.2%. Using standard preoperative variables from this multi-institutional RNU experience, we constructed and validated a nomogram for predicting peri-operative complications after RNU. Such information may permit more accurate risk stratification on an individual cases basis before major surgery. © 2016 The Authors BJU International © 2016 BJU International Published by John Wiley & Sons Ltd.

[Clinical Analysis of Icotinib on Beneficiary of 
Advanced Non-small Cell Lung Cancer with EGFR Common Mutation].

PubMed

Jiang, Xiaowen; Wang, Wenxian; Zhang, Yiping

2016-04-20

Targeted therapy has become an indispensable therapy method in advanced non-small cell lung cancer (NSCLC) treatment. Epithelial growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) can significantly prolong the survival of patients harboring EGFR gene mutation. Icotinb is China's first EGFR-TKI with independent intellectual property rights. The aim of this study is to investigate the clinical characteristics about the beneficiary of advanced NSCLC patients with EGFR Common mutation who were treated with Icotinib. Retrospectively collect the data about beneficiary [progression-free survival (PFS)≥6 months] and analysis of the related risk factors for prognosis. From September 1, 2011 to September 30, 2015, 231 cases of advanced NSCLC beneficiary with EGFR common mutation were enrolled for treatment with icotinib in Zhejiang Cancer Hospital. The one year benefit rate was 67.9% in the group treated with Icotinib as first line, and in the groupas second line or above was 53.6%, which is statisticallysignificant. The two years benefit rate was 18.7% and 9.3%, respectively. The median PFS of first line group and the second line or above was 16.7 and 12.4 months, respectively. The presence of brain metastasis (P=0.010), Prior chemotherapy (P=0.001), Eastern Cooperative Oncology Group (ECOG) score (P=0.001) were the main factors influencing the prognosis. The most common adverse were skin rashes (51 cases, 22.1%) and diarrhea (27 cases, 11.7%). Icotinib offers long-term clinical benefit and good tolerance for advanced NSCLC harboring EGFR gene mutation. Its advantage groups in addition to the patients with brain metastases and better ECOG score, the curative effect of patients with the first-line treatment is superior to second or further line. 
.

A matched-pair study comparing whole-brain irradiation alone to radiosurgery or fractionated stereotactic radiotherapy alone in patients irradiated for up to three brain metastases.

PubMed

Rades, Dirk; Janssen, Stefan; Dziggel, Liesa; Blanck, Oliver; Bajrovic, Amira; Veninga, Theo; Schild, Steven E

2017-01-06

This matched-pair study was initiated to validate the results of a retrospective study of 186 patients published in 2007 that compared whole-brain irradiation (WBI) alone and radiosurgery (RS) alone for up to three brain metastases. One-hundred-fifty-two patients receiving WBI alone for up to three brain metastases were matched with 152 patients treated with RS of fractionated stereotactic radiotherapy (FSRT) alone 1:1 for each of eight factors (age, gender, Eastern Oncology Cooperative Group (ECOG)-performance score, nature of tumor, brain metastases number, extra-cerebral spread, period from cancer detection to irradiation of brain metastases, and recursive partitioning analysis (RPA)-class. Groups were analyzed regarding intracerebral control (IC) and overall survival (OS). On univariate analysis of IC, type of irradiation did not significantly affect outcomes (p = 0.84). On Cox regression, brain metastases number (p < 0.001), nature of tumor (p < 0.001) and period from cancer detection to irradiation of brain metastases (p = 0.013) were significantly associated with IC. On univariate analysis of OS, type of irradiation showed no significant association with outcomes (p = 0.63). On multivariate analyses, OS was significantly associated with ECOG performance score (p = 0.011), nature of tumor (p = 0.035), brain metastases number (p = 0.048), extra-cerebral spread (p = 0.002) and RPA-class (p < 0.001). In this matched-pair study, RS/FSRT alone was not superior to WBI alone regarding IC and OS. These results can be considered a revision of the findings from our retrospective previous study without matched-pair design, where RS alone resulted in significantly better IC than WBI alone on multivariate analysis.

Inflammatory back pain in psoriatic arthritis is significantly more responsive to corticosteroids compared to back pain in ankylosing spondylitis: a prospective, open-labelled, controlled pilot study.

PubMed

Haroon, Muhammad; Ahmad, Muddassar; Baig, Muhammad Nouman; Mason, Olivia; Rice, John; FitzGerald, Oliver

2018-04-17

The efficacy of corticosteroids in patients with psoriatic arthritis (PsA) and inflammatory back pain has not been studied to date. In this controlled trial, we aimed to investigate the comparative performance of corticosteroids in patients with active axial-PsA (AxPsA) versus those with active ankylosing spondylitis (AS). Patients with AxPsA and AS (naïve to biologic therapies), who not only had clinically active disease, but also had bone marrow oedema on magnetic resonance imaging of the sacroiliac joints, were recruited. Clinically active disease was defined as inflammatory back pain (fulfilling Assessment of Spondyloarthritis International Society (ASAS) expert criteria), with spinal pain score (numerical rating scale 0-10) ≥4 and Bath AS Disease Activity Index (BASDAI) score ≥4 despite taking nonsteroidal anti-inflammatory drugs. Moreover, we recruited a control group of patients with non-inflammatory lower back pain. All patients received a single, intra-muscular dose of depot corticosteroid injection (triamcinolone acetonide 80 mg) at baseline. The intra-muscular corticosteroid option was used to overcome any drug compliance issues. Clinical outcome assessments were made at the following time points: baseline, week 2, and week 4. The primary efficacy end point was mean change in Ankylosing Spondylitis Disease Activity Score (ASDAS) at week 2. Key secondary outcomes were mean change in the BASDAI, Bath Ankylosing Spondylitis Functional Index (BASFI) and Ankylosing Spondylitis Quality of Life (ASQoL) at weeks 2 and 4. In total, 40 patients were recruited (15 with AxPsA, 15 with AS, and 10 controls). At week 2 following corticosteroid treatment, patients with AxPsA had significantly greater improvement in the mean ASDAS compared to patients with AS (1.43 ± 0.39 vs. 1.03 ± 0.30, p = 0.004), and also when compared to controls (p < 0.001). At week-4, similar significant trend of ASDAS improvement was seen among AxPsA patients compared to AS patients (1.09 ± 0.32 vs. 0.77 ± 0.27, p = 0.007) and controls (p < 0.001). Similarly, the mean BASDAI, visual analogue scale spinal pain score, ASQoL and BASFI improved significantly among patients with AxPsA compared to patients with AS and controls at week 2 (p < 0.05), with this trend also largely maintained at week 4. Axial inflammation in patients with PsA responds significantly better to corticosteroids than in patients with AS. This furthers the argument and adds to the growing evidence that AxPsA and AS are distinct entities.

Effects of extended pleurectomy and decortication on quality of life and pulmonary function in patients with malignant pleural mesothelioma.

PubMed

Burkholder, David; Hadi, Duraid; Kunnavakkam, Rangesh; Kindler, Hedy; Todd, Kristy; Celauro, Amy Durkin; Vigneswaran, Wickii T

2015-05-01

Maximal cytoreductive surgeries--extrapleural pneumonectomy and extended pleurectomy and decortication (EPD)--are effective surgical treatments in selected patients with malignant pleural mesothelioma. Extended pleurectomy and decortication results in equivalent survival yet better health-related quality of life (HRQoL). Patients with malignant pleural mesothelioma were studied for the effects of EPD on HRQoL and pulmonary function. The European Organization for Research and Treatment of Cancer Core Quality of Life Questionaire-C30 was used to evaluate HRQoL before operation, and at 4 to 5 and 7 to 8 months postoperatively. Pulmonary function tests were measured immediately before and 5 to 7 months after the operation. Patients were compared according to World Health Organization baseline performance status (PS). Of the 36 patients enrolled, 17 were PS 0 and 19 were PS 1 or PS 2 at baseline. Patients in groups PS 1 and PS 2 had significantly worse global health, functional, and symptoms scores. After EPD, PS 0 patients had no change in global health or function and symptoms scores except for emotional function, whereas PS 1 or PS 2 patients showed improvements at 4 to 5 months with further improvements at 7 to 8 months. The PS 0 patients demonstrated a significant decrease in forced vital capacity (p = 0.001), forced expiratory volume in 1 second (p = 0.002), total lung capacity (p = 0.0006) and diffusing capacity of the lung for carbon monoxide (p = 0.003) after EPD, whereas no change was observed in PS 1 and PS 2 patients. Extended pleurectomy and decortication did not improve overall HRQoL and had a negative impact in pulmonary function in minimally symptomatic patients. In symptomatic patients, a significant improvement in HRQoL was observed after EPD, which continued at late follow-up, although the pulmonary function was not affected. As changes in HRQoL are multidimensional, the preservation of the pulmonary function may have contributed to the net benefit observed in PS 1 and PS 2 patients. Copyright © 2015 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.

Irinotecan and temozolomide in recurrent Ewing sarcoma: an analysis in 51 adult and pediatric patients.

PubMed

Palmerini, E; Jones, R L; Setola, E; Picci, P; Marchesi, E; Luksch, R; Grignani, G; Cesari, M; Longhi, A; Abate, M E; Paioli, A; Szucs, Z; D'ambrosio, L; Scotlandi, K; Fagioli, F; Asaftei, S; Ferrari, S

2018-03-13

Data on temozolomide (TEM) and irinotecan (IRI) activity in recurrent Ewing sarcoma (EWS), especially in adult patients, are limited. Patients receiving TEM 100 mg/m 2 /day oral, and IRI 40 mg/m 2 /day intravenous, days 1-5, every 21 days, were included in this multi-institutional retrospective study. Disease control rate (DCR) [overall response rate (ORR) [complete response (CR) + partial response (PR)] + stable disease (SD)], 6-months progression-free survival (6-mos PFS) and 1-year overall survival (OS) were assessed. The median age of the 51 patients was 21 years (range 3-65 years): 34 patients (66%) were adults (≥18 years of age), 24 (48%) had ECOG 1 and 35 (69%) were presented with multiple site recurrence. TEMIRI was used at first relapse/progression in 13 (25%) patients, while the remainder received TEMIRI for second or greater relapse/progression. Fourteen (27%) patients had received prior myeloablative therapy with busulfan and melphalan. We observed five (10%) CR, 12 (24%) PR and 19 (37%) SD, with a DCR of 71%. 6-mos PFS was 49% (95% CI 35-63) and it was significantly influenced by ECOG (6-mos PFS 64% [95% CI 45-83] for ECOG 0, 34% [95% CI 14-54] for ECOG ≥1; p = .006) and LDH (6-mos PFS 62% [95% CI 44-79] for normal LDH, 22% [95% CI 3-42] for high LDH; p = .02), with no difference according to line of treatment, age and metastatic pattern. One-year OS was 55% (95% CI 39-70), with RECIST response (p = .001) and ECOG (p = .0002) independently associated with outcome. Grade 3 and 4 toxicity included neutropenia in 12% of patients, thrombocytopenia in 4%, diarrhea in 4%. This series confirms the activity of TEMIRI in both adults and pediatric patients. This schedule offers a 71% DCR, independently of the line of chemotherapy. Predictive factors of response are ECOG and LDH.

A PK-PD model of ketamine-induced high-frequency oscillations

NASA Astrophysics Data System (ADS)

Flores, Francisco J.; Ching, ShiNung; Hartnack, Katharine; Fath, Amanda B.; Purdon, Patrick L.; Wilson, Matthew A.; Brown, Emery N.

2015-10-01

Objective. Ketamine is a widely used drug with clinical and research applications, and also known to be used as a recreational drug. Ketamine produces conspicuous changes in the electrocorticographic (ECoG) signals observed both in humans and rodents. In rodents, the intracranial ECoG displays a high-frequency oscillation (HFO) which power is modulated nonlinearly by ketamine dose. Despite the widespread use of ketamine there is no model description of the relationship between the pharmacokinetic-pharmacodynamics (PK-PDs) of ketamine and the observed HFO power. Approach. In the present study, we developed a PK-PD model based on estimated ketamine concentration, its known pharmacological actions, and observed ECoG effects. The main pharmacological action of ketamine is antagonism of the NMDA receptor (NMDAR), which in rodents is accompanied by an HFO observed in the ECoG. At high doses, however, ketamine also acts at non-NMDAR sites, produces loss of consciousness, and the transient disappearance of the HFO. We propose a two-compartment PK model that represents the concentration of ketamine, and a PD model based in opposing effects of the NMDAR and non-NMDAR actions on the HFO power. Main results. We recorded ECoG from the cortex of rats after two doses of ketamine, and extracted the HFO power from the ECoG spectrograms. We fit the PK-PD model to the time course of the HFO power, and showed that the model reproduces the dose-dependent profile of the HFO power. The model provides good fits even in the presence of high variability in HFO power across animals. As expected, the model does not provide good fits to the HFO power after dosing the pure NMDAR antagonist MK-801. Significance. Our study provides a simple model to relate the observed electrophysiological effects of ketamine to its actions at the molecular level at different concentrations. This will improve the study of ketamine and rodent models of schizophrenia to better understand the wide and divergent range of effects that ketamine has.

Predicting survival in geriatric trauma patients: A comparison between the TRISS methodology and the Geriatric Trauma Outcome Score.

PubMed

Barea-Mendoza, Jesús Abelardo; Chico-Fernández, Mario; Sánchez-Casado, Marcelino; Molina-Díaz, Ismael; Quintana-Díaz, Manuel; Jiménez-Moragas, José Manuel; Pérez-Bárcena, Jon; Llompart-Pou, Juan Antonio

We compared the Geriatric Trauma Outcome Score (GTOS) with the probability of survival using the TRISS methodology (PS-TRISS) in geriatric severe trauma patients admitted to Intensive Care Units (ICU) participating in the Spanish trauma ICU registry (RETRAUCI). Retrospective analysis from the RETRAUCI. Quantitative data were reported as median (Interquartile Range (IQR)), and categorical data as number (percentage). We analyzed the validity of the GTOS and PS-TRISS to predict survival. Discrimination was analyzed using receiver operating characteristics curves. Calibration was analyzed using the Hosmer-Lemeshow goodness-of-fit test. A P value <.05 was considered statistically significant. The cohort included 1417 patients aged ≥ 65 years. Median age was 75.5 (70.5-80.5), 1003 patients were male (68.2%) and median Injury Severity Score was 18 (13-25). Mechanical ventilation was required in 61%. Falls were the mechanism of injury in 659 patients (44.8%). In-hospital mortality rate was 18.2%. The areas under the curve were: PS-TRISS 0.69 (95%CI 0.66-0.73), and GTOS 0.66 (95%CI 0.62-0.70); P<.05. Both scores overestimated mortality in the upper range of predicted mortality. In our sample of geriatric severe trauma patients, the accuracy of GTOS was lower than the accuracy of the PS-TRISS to predict in-hospital survival. The calibration of both scores for the geriatric population was deficient. Copyright © 2018 AEC. Publicado por Elsevier España, S.L.U. All rights reserved.

Comparison of force plate gait analysis and owner assessment of pain using the Canine Brief Pain Inventory in dogs with osteoarthritis.

PubMed

Brown, D C; Boston, R C; Farrar, J T

2013-01-01

Lameness assessment using force plate gait analysis (FPGA) and owner assessment of chronic pain using the Canine Brief Pain Inventory (CBPI) are valid and reliable methods of evaluating canine osteoarthritis. There are no studies comparing these 2 outcome measures. Evaluate the relationship between CBPI pain severity (PS) and interference (PI) scores with the vertical forces of FPGA as efficacy measures in canine osteoarthritis. Sixty-eight client-owned dogs with osteoarthritis (50 hind limb and 18 forelimb). Double-blind, randomized. Owners completed the CBPI, and dogs underwent FPGA on days 0 and 14. Dogs received carprofen or placebo on days 1 through 14. The change in PS and PI scores from day 0 to 14 were compared to the change in peak vertical force (PVF) and vertical impulse (VI). PS and PI scores significantly decreased in carprofen- compared with placebo-treated dogs (P = .002 and P = .03, respectively). PVF and VI significantly increased in carprofen- compared with placebo-treated dogs (P = .006 and P = .02, respectively). There was no correlation or concordance between the PS or PI score changes and change in PVF or VI. In these dogs with hind limb or forelimb osteoarthritis, owner assessment of chronic pain using the CBPI and assessment of lameness using FPGA detected significant improvement in dogs treated with carprofen. The lack of correlation or concordance between the change in owner scores and vertical forces suggests that owners were focused on behaviors other than lameness when making efficacy evaluations in their dogs. Copyright © 2012 by the American College of Veterinary Internal Medicine.

Development of an ultra low noise, miniature signal conditioning device for vestibular evoked response recordings

PubMed Central

2014-01-01

Background Inner ear evoked potentials are small amplitude (<1 μVpk) signals that require a low noise signal acquisition protocol for successful extraction; an existing such technique is Electrocochleography (ECOG). A novel variant of ECOG called Electrovestibulography (EVestG) is currently investigated by our group, which captures vestibular responses to a whole body tilt. The objective is to design and implement a bio-signal amplifier optimized for ECOG and EVestG, which will be superior in noise performance compared to low noise, general purpose devices available commercially. Method A high gain configuration is required (>85 dB) for such small signal recordings; thus, background power line interference (PLI) can have adverse effects. Active electrode shielding and driven-right-leg circuitry optimized for EVestG/ECOG recordings were investigated for PLI suppression. A parallel pre-amplifier design approach was investigated to realize low voltage, and current noise figures for the bio-signal amplifier. Results In comparison to the currently used device, PLI is significantly suppressed by the designed prototype (by >20 dB in specific test scenarios), and the prototype amplifier generated noise was measured to be 4.8 nV/Hz @ 1 kHz (0.45 μVRMS with bandwidth 10 Hz-10 kHz), which is lower than the currently used device generated noise of 7.8 nV/Hz @ 1 kHz (0.76 μVRMS). A low noise (<1 nV/Hz) radio frequency interference filter was realized to minimize noise contribution from the pre-amplifier, while maintaining the required bandwidth in high impedance measurements. Validation of the prototype device was conducted for actual ECOG recordings on humans that showed an increase (p < 0.05) of ~5 dB in Signal-to-Noise ratio (SNR), and for EVestG recordings using a synthetic ear model that showed a ~4% improvement (p < 0.01) over the currently used amplifier. Conclusion This paper presents the design and evaluation of an ultra-low noise and miniaturized bio-signal amplifier tailored for EVestG and ECOG. The increase in SNR for the implemented amplifier will reduce variability associated with bio-features extracted from such recordings; hence sensitivity and specificity measures associated with disease classification are expected to increase. Furthermore, immunity to PLI has enabled EVestG and ECOG recordings to be carried out in a non-shielded clinical environment. PMID:24468042

Measuring changes in perception using the Student Perceptions of Physician-Pharmacist Interprofessional Clinical Education (SPICE) instrument.

PubMed

Zorek, Joseph A; MacLaughlin, Eric J; Fike, David S; MacLaughlin, Anitra A; Samiuddin, Mohammed; Young, Rodney B

2014-05-20

The Student Perceptions of Physician-Pharmacist Interprofessional Clinical Education (SPICE) instrument contains 10 items, 3 factors (interprofessional teamwork and team-based practice, roles/responsibilities for collaborative practice, and patient outcomes from collaborative practice), and utilizes a five-point response scale (1 = strongly disagree, 5 = strongly agree). Given the SPICE instrument's demonstrated validity and reliability, the objective of this study was to evaluate whether it was capable of measuring changes in medical (MS) and pharmacy students' (PS) perceptions following an interprofessional education (IPE) experience. In this prospective cohort study, MS and PS completed the SPICE instrument before and after participation in a predefined IPE experience. Descriptive statistics were used to characterize students and pre-post responses. Independent samples t tests and Fisher's Exact tests were used to assess group difference in demographic variables. Mann Whitney U tests were used to assess between-group differences in item scores. Wilcoxon Signed-Rank tests were used to evaluate post-participation changes in item scores. Spearman correlations were calculated to assess associations between ordinal demographic variables and item scores, and whether the number of clinic visits completed was associated with post-test responses. Paired samples t tests were used to calculate mean score changes for each of the factors. Thirty-four MS and 15 PS were enroled. Baseline differences included age (25.3. ± 1.3 MS vs. 28.7 ± 4.4 PS; p = 0.013), years full-time employment (0.71 ± 0.97 MS vs. 4.60 ± 4.55 PS; p < 0.001), and number of prior IPE rotations (1.41 ± 1.74 MS vs. 3.13 ± 2.1 PS; p < 0.001). Two items generated baseline differences; 1 persisted post-participation: whether MS/PS should be involved in teamwork (3.91 MS vs. 4.60 PS; p < 0.001). For all students, significant mean score increases were observed for role clarity ("my role" [3.72 vs. 4.11; p = 0.001] and "others' roles" [3.87 vs. 4.17; p = 0.001]), impact of teamwork on patient satisfaction (3.72 vs. 4.34; p < 0.001), and ideal curricular location for IPE (4.06 vs. 4.34; p = 0.002). Significant increases were observed for all three factors (teamwork, p = 0.003; roles/responsibilities and patient outcomes, p < 0.001). This study demonstrated the SPICE instrument's ability to measure changes in perception for medical and pharmacy students exposed to an IPE experience, both at the individual item level and at the factor level.

Sequential cohort design applying propensity score matching to analyze the comparative effectiveness of atorvastatin and simvastatin in preventing cardiovascular events.

PubMed

Helin-Salmivaara, Arja; Lavikainen, Piia; Aarnio, Emma; Huupponen, Risto; Korhonen, Maarit Jaana

2014-01-01

Sequential cohort design (SCD) applying matching for propensity scores (PS) in accrual periods has been proposed to mitigate bias caused by channeling when calendar time is a proxy for strong confounders. We studied the channeling of patients according to atorvastatin and simvastatin initiation in Finland, starting from the market introduction of atorvastatin in 1998, and explored the SCD PS approach to analyzing the comparative effectiveness of atorvastatin versus simvastatin in the prevention of cardiovascular events (CVE). Initiators of atorvastatin or simvastatin use in the 45-75-year age range in 1998-2006 were characterized by their propensity of receiving atorvastatin over simvastatin, as estimated for 17 six-month periods. Atorvastatin (10 mg) and simvastatin (20 mg) initiators were matched 1∶1 on the PS, as estimated for the whole cohort and within each period. Cox regression models were fitted conventionally, and also for the PS matched cohort and the periodically PS matched cohort, to estimate the hazard ratios (HR) for CVEs. Atorvastatin (10 mg) was associated with a 11%-12% lower incidence of CVE in comparison with simvastatin (20 mg). The HR estimates were the same for a conventional Cox model (0.88, 95% confidence interval 0.85-0.91), for the analysis in which the PS was used to match across all periods and the Cox model was adjusted for strong confounders (0.89, 0.85-0.92), and for the analysis in which PS matching was applied within sequential periods (0.88, 0.84-0.92). The HR from a traditional PS matched analysis was 0.80 (0.77-0.83). The SCD PS approach produced effect estimates similar to those obtained in matching for PS within the whole cohort and adjusting the outcome model for strong confounders, but at the cost of efficiency. A traditional PS matched analysis without further adjustment in the outcome model produced estimates further away from unity.

Efficacy and Safety of Ixekizumab in a Randomized, Double-Blinded, Placebo-Controlled Phase 3b Study of Patients with Moderate-to-Severe Genital Psoriasis.

PubMed

Ryan, C; Menter, A; Guenther, L; Blauvelt, A; Bissonnette, R; Meeuwis, K; Sullivan, J; Cather, J C; Yosipovitch, G; Gottlieb, A B; Merola, J F; Callis Duffin, K; Fretzin, S; Osuntokun, O O; Burge, R; Naegeli, A N; Yang, F E; Lin, C-Y; Todd, K; Potts Bleakman, A

2018-05-10

Genital psoriasis (GenPs) is a common, debilitating, and difficult to treat manifestation of plaque psoriasis. However, few controlled, interventional studies of GenPs exist. To determine the efficacy of ixekizumab versus placebo in patients with moderate-to-severe GenPs with BSA≥1%. Subjects with moderate-to-severe GenPs (defined as a baseline static Physician's Global Assessment of Genitalia [sPGA-G] score of ≥3) with BSA≥1% were randomized 1:1 to receive placebo (N=74) or the recommended dosing of ixekizumab (N=75). Major outcomes included the percentage of patients achieving 0 or 1 scores on the sPGA-G (primary endpoint), overall sPGA, GenPs Sexual Frequency Questionnaire (GenPs-SFQ) item 2, and a ≥3-point improvement from baseline on the GenPs itch numeric rating scale. At week 12, ixekizumab was superior to placebo on the sPGA-G 0/1 (73.3% versus 8.1%, p<0.001), overall sPGA 0/1 (73.3% versus 2.7%, p<0.001), GenPs-SFQ item 2 0/1 (78.4% versus 21.4%, p<0.001), and genital itch (59.7% versus 8.3%, p<0.001). No candidiasis was reported, no deaths occurred, and one (1.4%) serious adverse event was reported in a patient receiving placebo. Ixekizumab was superior to placebo for the treatment of moderate-to-severe GenPs with BSA≥1%. The safety profile of ixekizumab was consistent with previous studies in moderate-to-severe plaque psoriasis. This article is protected by copyright. All rights reserved. This article is protected by copyright. All rights reserved.

Axial Disease in Psoriatic Arthritis study: defining the clinical and radiographic phenotype of psoriatic spondyloarthritis.

PubMed

Jadon, Deepak R; Sengupta, Raj; Nightingale, Alison; Lindsay, Mark; Korendowych, Eleanor; Robinson, Graham; Jobling, Amelia; Shaddick, Gavin; Bi, Jing; Winchester, Robert; Giles, Jon T; McHugh, Neil J

2017-04-01

To compare the prevalence, clinical and radiographic characteristics of psoriatic spondyloarthritis (PsSpA) in psoriatic arthritis (PsA), with ankylosing spondylitis (AS). A prospective single-centre cross-sectional observational study recruited consecutive PsA and AS cases. Participants completed outcome measures, and underwent clinical examination, axial radiographic scoring and HLA- sequencing. Multivariable analyses are presented. The 402 enrolled cases (201 PsA, 201 AS; fulfilling classification criteria for respective conditions) were reclassified based upon radiographic axial disease and psoriasis, as: 118 PsSpA, 127 peripheral-only PsA (pPsA), and 157 AS without psoriasis (AS) cases. A significant proportion of patients with radiographic axial disease had PsSpA (118/275; 42.91%), and often had symptomatically silent axial disease (30/118; 25.42%). Modified New York criteria for AS were fulfilled by 48/201 (23.88%) PsA cases, and Classification of Psoriatic Arthritis criteria by 49/201 (24.38%) AS cases. pPsA compared with PsSpA cases had a lower frequency of HLA-B*27 (OR 0.12; 95% CI 0.05 to 0.25). Disease activity, metrology and disability were comparable in PsSpA and AS. A significant proportion of PsSpA cases had spondylitis without sacroiliitis (39/118; 33.05%); they less frequently carried HLA-B*27 (OR 0.11; 95% CI 0.04 to 0.33). Sacroiliac joint complete ankylosis (adjusted OR, OR adj 2.96; 95% CI 1.42 to 6.15) and bridging syndesmophytes (OR adj 2.78; 95% CI 1.49 to 5.18) were more likely in AS than PsSpA. Radiographic axial disease was more severe in AS than PsSpA (Psoriatic Arthritis Spondylitis Radiology Index Score: adjusted incidence risk ratio 1.13; 95% CI 1.09 to 1.19). In a combined cohort of patients with either PsA or AS from a single centre, 24% fulfilled classification criteria for both conditions. The pattern of axial disease was influenced significantly by the presence of skin psoriasis and HLA-B*27 . Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

Validation of the Dementia Care Assessment Packet-Instrumental Activities of Daily Living

PubMed Central

Lee, Seok Bum; Park, Jeong Ran; Yoo, Jeong-Hwa; Park, Joon Hyuk; Lee, Jung Jae; Yoon, Jong Chul; Jhoo, Jin Hyeong; Lee, Dong Young; Woo, Jong Inn; Han, Ji Won; Huh, Yoonseok; Kim, Tae Hui

2013-01-01

Objective We aimed to evaluate the psychometric properties of the IADL measure included in the Dementia Care Assessment Packet (DCAP-IADL) in dementia patients. Methods The study involved 112 dementia patients and 546 controls. The DCAP-IADL was scored in two ways: observed score (OS) and predicted score (PS). The reliability of the DCAP-IADL was evaluated by testing its internal consistency, inter-rater reliability and test-retest reliability. Discriminant validity was evaluated by comparing the mean OS and PS between dementia patients and controls by ANCOVA. Pearson or Spearman correlation analysis was performed with other instruments to assess concurrent validity. Receiver operating characteristics curve analysis was performed to examine diagnostic accuracy. Results Chronbach's α coefficients of the DCAP-IADL were above 0.7. The values in dementia patients were much higher (OS=0.917, PS=0.927), indicating excellent degrees of internal consistency. Inter-rater reliabilities and test-retest reliabilities were statistically significant (p<0.05). PS exhibited higher reliabilities than OS. The mean OS and PS of dementia patients were significantly higher than those of the non-demented group after controlling for age, sex and education level. The DCAP-IADL was significantly correlated with other IADL instruments and MMSE-KC (p<0.001). Areas under the curves of the DCAP-IADL were above 0.9. Conclusion The DCAP-IADL is a reliable and valid instrument for evaluating instrumental ability of daily living for the elderly, and may also be useful for screening dementia. Moreover, administering PS may enable the DCAP-IADL to overcome the differences in gender, culture and life style that hinders accurate evaluation of the elderly in previous IADL instruments. PMID:24302946

Development and validation of a new instrument to measure health-related quality of life in patients with psoriatic arthritis: the VITACORA-19.

PubMed

Torre-Alonso, Juan Carlos; Gratacós, Jordi; Rey-Rey, José Santos; Valdazo de Diego, Juan Pablo; Urriticoechea-Arana, Ana; Daudén, Esteban; Moreno, Mireia; Zarco-Montejo, Pedro; Collantes-Estévez, Eduardo; Fernández-López, Juan Antonio

2014-10-01

To develop/validate an instrument to measure health-related quality of life (HRQoL) in patients with psoriatic arthritis (PsA), for use in clinical studies. An item pool of 35 items was generated following standardized procedures. Item reduction was performed using clinimetric and psychometric approaches after administration to 66 patients with PsA. The resulting instrument, the VITACORA-19, consists of 19 items. Its validity content, internal consistency, test-retest reliability, known groups/convergent validity, and sensitivity to change were tested in a longitudinal and multicenter study conducted in 10 hospitals in Spain, with 323 patients who also completed the EuroQol 5-dimensional questionnaire (EQ-5D) and a health status transition item. There were 3 study groups: group A (n = 209, patients with PsA), group B (n = 71, patients with arthritis without psoriatic aspect, patients with arthrosis, and patients with dermatitis), and group C (n = 43, healthy controls). The questionnaire was considered easy/very easy to answer by 94.7% of the patients with PsA. The factorial analysis clearly identified only 1 factor. Cronbach's alpha coefficient and interclass correlation coefficients exceeded 0.90. Statistically significant differences (p < 0.001) were observed between groups: subjects from group C had better HRQoL, followed by group B, and finally group A had the worst HRQoL. The VITACORA-19 scores showed significant correlations (p < 0.001) to PsA disease activity, EQ-5D, and perceived health state, scoring the patients with better health state higher. The minimum important difference was established as an 8-point change in the global score. The Spanish-developed VITACORA-19, designed to measure HRQoL in patients with PsA, has good validity, reliability, and sensitivity to change.

Physical Activity and Physical Fitness in Pediatric Obesity: What are the First Steps for Clinicians? Expert Conclusion from the 2016 ECOG Workshop

PubMed Central

O’MALLEY, GRACE; RING-DIMITRIOU, SUSANNE; NOWICKA, PAULINA; VANIA, ANDREA; FRELUT, MARIE-LAURE; FARPOUR-LAMBERT, NATHALIE; WEGHUBER, DANIEL; THIVEL, DAVID

2017-01-01

One of the main aims of the European Childhood Obesity Group (ECOG) is to assist healthcare workers in delivering evidence-based assessment and treatment of childhood obesity. Every year the ECOG Congress includes working groups whose objective is to highlight concerns faced by clinicians and practitioners who work in the field of pediatric obesity. This year, a working group was devoted to the assessment of physical activity and physical fitness in this population. The present commentary attempts to summarize the main themes identified by practitioners during these workshops in order to provide the basic and essential first steps required to address physical activity and fitness in children with obesity. PMID:28674594

Different intraoperative kinematics with comparable clinical outcomes of ultracongruent and posterior stabilized mobile-bearing total knee arthroplasty.

PubMed

Kim, Tae Woo; Lee, Sang Min; Seong, Sang Cheol; Lee, Sahnghoon; Jang, Jak; Lee, Myung Chul

2016-09-01

There remains no consensus as to whether mobile total knee arthroplasty (TKA) should use a posterior cruciate ligament-sacrificing ultracongruent (UC) or a posterior cruciate ligament-substituting posterior stabilized (PS) prosthesis. The purpose of this study was to assess intraoperative kinematics and clinical outcomes of UC and PS rotating platform mobile-bearing TKA. In this randomized controlled study, mobile UC TKA prostheses (n = 45) were compared with mobile PS TKA prostheses (n = 45) with regard to intraoperative kinematics and clinical outcomes. The passive kinematic study using intraoperative navigation system included anterior/posterior translation, varus/valgus alignment and rotation of femur during flexion. The patients were clinically and radiographically evaluated over a 3-year follow-up. Paradoxical anterior translation of the femur was 10.8 ± 5.2 mm in the UC knee from 0° to 82° of knee flexion and 8.7 ± 3.0 mm in the PS knee from 0° to 70° of knee flexion (p = 0.027). Paradoxical internal rotation of the femur was 5.8° in the UC knees and 9.9° in the PS knees (p = 0.003). But, there was no significant difference between the groups in regard to the coronal alignment. There was no significant difference in the range of motion, KS knee scores, KS function scores, and WOMAC index scores. Despite different intraoperative kinematics between mobile UC and mobile PS TKA, neither design reproduced physiologic knee kinematics and there was no difference in clinical outcomes between the two groups. The clinical relevance of the study is that despite different intraoperative kinematics, UC design can be a considerable alternative to PS design in mobile-bearing TKA in respect of clinical outcomes. II.

Effects of aggregation of drug and diagnostic codes on the performance of the high-dimensional propensity score algorithm: an empirical example.

PubMed

Le, Hoa V; Poole, Charles; Brookhart, M Alan; Schoenbach, Victor J; Beach, Kathleen J; Layton, J Bradley; Stürmer, Til

2013-11-19

The High-Dimensional Propensity Score (hd-PS) algorithm can select and adjust for baseline confounders of treatment-outcome associations in pharmacoepidemiologic studies that use healthcare claims data. How hd-PS performance is affected by aggregating medications or medical diagnoses has not been assessed. We evaluated the effects of aggregating medications or diagnoses on hd-PS performance in an empirical example using resampled cohorts with small sample size, rare outcome incidence, or low exposure prevalence. In a cohort study comparing the risk of upper gastrointestinal complications in celecoxib or traditional NSAIDs (diclofenac, ibuprofen) initiators with rheumatoid arthritis and osteoarthritis, we (1) aggregated medications and International Classification of Diseases-9 (ICD-9) diagnoses into hierarchies of the Anatomical Therapeutic Chemical classification (ATC) and the Clinical Classification Software (CCS), respectively, and (2) sampled the full cohort using techniques validated by simulations to create 9,600 samples to compare 16 aggregation scenarios across 50% and 20% samples with varying outcome incidence and exposure prevalence. We applied hd-PS to estimate relative risks (RR) using 5 dimensions, predefined confounders, ≤ 500 hd-PS covariates, and propensity score deciles. For each scenario, we calculated: (1) the geometric mean RR; (2) the difference between the scenario mean ln(RR) and the ln(RR) from published randomized controlled trials (RCT); and (3) the proportional difference in the degree of estimated confounding between that scenario and the base scenario (no aggregation). Compared with the base scenario, aggregations of medications into ATC level 4 alone or in combination with aggregation of diagnoses into CCS level 1 improved the hd-PS confounding adjustment in most scenarios, reducing residual confounding compared with the RCT findings by up to 19%. Aggregation of codes using hierarchical coding systems may improve the performance of the hd-PS to control for confounders. The balance of advantages and disadvantages of aggregation is likely to vary across research settings.

Evaluation of Magnetic Resonance Imaging Responsiveness in Active Psoriatic Arthritis at Multiple Timepoints during the First 12 Weeks of Antitumor Necrosis Factor Therapy.

PubMed

Feletar, Marie; Hall, Stephen; Bird, Paul

2016-01-01

To assess the responsiveness of high- and low-field extremity magnetic resonance imaging (MRI) variables at multiple timepoints in the first 12 weeks post-antitumor necrosis factor (anti-TNF) therapy initiation in patients with psoriatic arthritis (PsA) and active dactylitis. Twelve patients with active PsA and clinical evidence of dactylitis involving at least 1 digit were recruited. Patients underwent sequential high-field conventional (1.5 Tesla) and extremity low-field MRI (0.2 Tesla) of the affected hand or foot, pre- and postgadolinium at baseline (pre-TNF), 2 weeks (post-TNF), 6 weeks, and 12 weeks. A blinded observer scored all images on 2 occasions using the PsA MRI scoring system. Eleven patients completed the study, but only 6 patients completed all high-field and low-field MRI assessments. MRI scores demonstrated rapid response to TNF inhibition with score reduction in tenosynovitis, synovitis, and osteitis at 2 weeks. Intraobserver reliability was good to excellent for all variables. High-field MRI demonstrated greater sensitivity to tenosynovitis, synovitis, and osteitis and greater responsiveness to change posttreatment. Treatment responses were maintained to 12 weeks. This study demonstrates the use of MRI in detecting early response to biologic therapy. MRI variables of tenosynovitis, synovitis, and osteitis demonstrated responsiveness posttherapy with high-field scores more responsive to change than low-field scores.

Construct validity of the modified numeric rating scale of patient global assessment in psoriatic arthritis.

PubMed

Leung, Ying-Ying; Ho, Kwok-Wah; Zhu, Tracy-Yanner; Tam, Lai-Shan; Kun, Emily Wailin; Li, Edmund Kwok-Ming

2012-04-01

The construct validity of the patient global health assessment (PGA) in psoriatic arthritis (PsA) has not been analyzed, despite its common use. We evaluated the construct validity of a numeric rating scale (NRS) of the PGA in PsA. Patients with PsA who fulfilled the ClASsification for Psoriatic ARthritis (CASPAR) criteria were recruited at a tertiary referral center. Demographic data were collected and PGA data were determined from administration of an 11-point NRS (0 to 10 points representing best to worst status). Convergent and discriminant validity were evaluated by correlation between PGA and clinical variables. Patients were grouped as having severe disease based on Disease Activity Score 28-joint count (DAS28) > 5.1, Health Assessment Questionnaire (HAQ) > 1.0, walking with aids, and social welfare-dependent. Patients were grouped as being in remission by DAS28 < 2.6 and the Minimal Disease Activity Criteria. Known-group validity of PGA was evaluated. A total of 125 patients (52% men) were studied. Convergent validity revealed strong correlations of PGA with pain score, HAQ, and DAS28; and weak correlations with skin severity score, physician's global assessment and morning stiffness. In multivariate analysis, PGA was associated with pain, physical function, mental function, and skin severity score. PGA distinguished different levels of severity well, as determined by comparison with different known groups with large effect sizes. Judged on an NRS, the PGA had good construct validity and satisfactorily distinguished all levels of severity in PsA.

Clinical outcome of an alternative fotemustine schedule in elderly patients with recurrent glioblastoma: a mono-institutional retrospective study.

PubMed

Lombardi, Giuseppe; Bellu, Luisa; Pambuku, Ardi; Della Puppa, Alessandro; Fiduccia, Pasquale; Farina, Miriam; D'Avella, Domenico; Zagonel, Vittorina

2016-07-01

The optimal treatment of recurrent glioblastoma (GBM) in elderly patients is unclear. Fotemustine (FTM) is a third-generation nitrosourea showing efficacy in gliomas and it has been used with different schedules in adult patients. We performed, for the first time anywhere, a mono-institutional retrospective study to analyze the clinical outcome of an alternative fotemustine schedule in elderly patients with recurrent GBM. Retrospectively, we analyzed all GBM patients 65 years or older previously treated with the combination of radiation therapy and temozolomide (TMZ), receiving an alternative FTM schedule as second-line treatment at our Oncological Center from October 2011 to October 2014 with an ECOG PS ≤ 2. FTM was administrated at 80 mg/m(2) every 2 weeks for five consecutive administrations (induction phase), and then every 4 weeks at 80 mg/m(2) as maintenance. We enrolled 44 patients, 33 males and 11 females; average age was 70 years. ECOG PS was 0-1 in 80 % of the patients. 38 patients relapsed during temozolomide (TMZ) therapy. MGMT methylation status was analyzed in 34 patients and MGMT was methylated in 53 % of the patients. The median progression free survival (PFS) and overall survival (OS) from FTM treatment was 4.1 months (95 % CI 3.1-5.2) and 7 months (95 % CI 5.2-8.4), respectively. Patients with MGMT methylated status and patients who relapsed after completing TMZ therapy had a longer PFS and OS from the beginning of FTM. Thrombocytopenia was the most frequent grade 3-4 haematological toxicity (9 %). The alternative schedule of FTM may be an active and safe treatment for elderly patients with recurrent glioblastoma, especially patients with methylated MGMT and who relapsed after completing temozolomide therapy.

A retrospective multicentric observational study of trastuzumab emtansine in HER2 positive metastatic breast cancer: a real-world experience

PubMed Central

Vici, Patrizia; Pizzuti, Laura; Michelotti, Andrea; Sperduti, Isabella; Natoli, Clara; Mentuccia, Lucia; Lauro, Luigi Di; Sergi, Domenico; Marchetti, Paolo; Santini, Daniele; Magnolfi, Emanuela; Iezzi, Laura; Moscetti, Luca; Fabbri, Agnese; Cassano, Alessandra; Grassadonia, Antonino; Omarini, Claudia; Piacentini, Federico; Botticelli, Andrea; Bertolini, Ilaria; Scinto, Angelo Fedele; Zampa, Germano; Mauri, Maria; D’Onofrio, Loretta; Sini, Valentina; Barba, Maddalena; Maugeri-Saccà, Marcello; Rossi, Ernesto; Landucci, Elisabetta; Tomao, Silverio; Alberti, Antonio Maria; Giotta, Francesco; Ficorella, Corrado; Adamo, Vincenzo; Russo, Antonio; Lorusso, Vito; Cannita, Katia; Barni, Sandro; Laudadio, Lucio; Greco, Filippo; Garrone, Ornella; Giulia, Marina Della; Marolla, Paolo; Sanguineti, Giuseppe; Cocco, Barbara Di; Ciliberto, Gennaro; Maria, Ruggero De; Gamucci, Teresa

2017-01-01

We addressed trastuzumab emtansine (T-DM1) efficacy in HER2+ metastatic breast cancer patients treated in real-world practice, and its activity in pertuzumab-pretreated patients. We conducted a retrospective, observational study involving 23 cancer centres, and 250 patients. Survival data were analyzed by Kaplan Meier curves and log rank test. Factors testing significant in univariate analysis were tested in multivariate models. Median follow-up was 15 months and median T-DM1 treatment-length 4 months. Response rate was 41.6%, clinical benefit 60.9%. Median progression-free and median overall survival were 6 and 20 months, respectively. Overall, no differences emerged by pertuzumab pretreatment, with median progression-free and median overall survival of 4 and 17 months in pertuzumab-pretreated (p=0.13), and 6 and 22 months in pertuzumab-naïve patients (p=0.27). Patients who received second-line T-DM1 had median progression-free and median overall survival of 3 and 12 months (p=0.0001) if pertuzumab-pretreated, and 8 and 26 months if pertuzumab-naïve (p=0.06). In contrast, in third-line and beyond, median progression-free and median overall survival were 16 and 18 months in pertuzumab-pretreated (p=0.05) and 6 and 17 months in pertuzumab-naïve patients (p=0.30). In multivariate analysis, lower ECOG performance status was associated with progression-free survival benefit (p<0.0001), while overall survival was positively affected by lower ECOG PS (p<0.0001), absence of brain metastases (p 0.05), and clinical benefit (p<0.0001). Our results are comparable with those from randomized trials. Further studies are warranted to confirm and interpret our data on apparently lower T-DM1 efficacy when given as second-line treatment after pertuzumab, and on the optimal sequence order. PMID:28915642

Psychometric characteristics of the Rivermead Behavioural Memory Test (RBMT) as an early detection instrument for dementia and mild cognitive impairment in Brazil.

PubMed

Yassuda, Mônica Sanches; Flaks, Mariana Kneese; Viola, Luciane Fátima; Pereira, Fernanda Speggiorin; Memória, Claudia Maia; Nunes, Paula Villela; Forlenza, Orestes Vicente

2010-09-01

The Rivermead Behavioural Memory Test (RBMT) assesses everyday memory by means of tasks which mimic daily challenges. The objective was to examine the validity of the Brazilian version of the RBMT to detect cognitive decline. 195 older adults were diagnosed as normal controls (NC) or with mild cognitive impairment (MCI) or Alzheimer's disease (AD) by a multidisciplinary team, after participants completed clinical and neuropsychological protocols. Cronbach's alpha was high for the total sample for the RBMT profile (PS) and screening scores (SS) (PS = 0.91, SS = 0.87) and for the AD group (PS = 0.84, SS = 0.85), and moderate for the MCI (PS = 0.62, SS = 0.55) and NC (PS = 0.62, SS = 0.60) groups. RBMT total scores, Appointment, Pictures, Immediate and Delayed Story, Immediate and Delayed Route, Delayed Message and Date contributed to differentiate NC from MCI. ROC curve analyses indicated high accuracy to differentiate NC from AD patients, and, moderate accuracy to differentiate NC from MCI. The Brazilian version of the RBMT seems to be an appropriate instrument to identify memory decline in Brazilian older adults.

Demographics, clinical disease characteristics, and quality of life in a large cohort of psoriasis patients with and without psoriatic arthritis

PubMed Central

Truong, B; Rich-Garg, N; Ehst, BD; Deodhar, AA; Ku, JH; Vakil-Gilani, K; Danve, A; Blauvelt, A

2015-01-01

Innovation What is already known about the topic: psoriasis (PsO) is a common skin disease with major impact on quality of life (QoL). Patient-reported data on QoL from large number of PsO patients with and without psoriatic arthritis (PsA) are limited. What this study adds: In a large cohort referred to a university psoriasis center, patients with PsO and concomitant PsA (~30% in this group) had greater degrees of skin and nail involvement and experienced greater negative impacts on QoL. Despite large numbers of patients with moderate-to-severe disease, use of systemic therapy by community practitioners was uncommon. Background PsO and PsA are common diseases that have marked adverse impacts on QoL. The disease features and patient-reported QoL data comparing PsO and PsA patients are limited. Objective To identify and compare demographics, clinical disease characteristics, and QoL scores in a large cohort of PsO patients with and without PsA. Methods All PsO patients seen in a psoriasis specialty clinic, named the Center of Excellence for Psoriasis and Psoriatic Arthritis, were enrolled in an observational cohort. Demographic, QoL, and clinical data were collected from patient-reported questionnaires and from physical examinations performed by Center of Excellence for Psoriasis and Psoriatic Arthritis dermatologists and a rheumatologists. Cross sectional descriptive data were collected and comparisons between patients with PsO alone and those with concomitant PsA are presented. Results A total of 568 patients were enrolled in the database. Mean age of PsO onset was 28 years and mean disease duration was 18 years. Those with family history had an earlier onset of PsO by ~7 years. Mean body surface area involvement with PsO was 14%. Mean body mass index was 30.7. Prevalence of PsA was 29.8%. PsA patients had a higher mean body surface area compared to patients with PsO alone (16.7% vs 13.4%, P<0.05), higher prevalence of psoriatic nail changes (54.4% vs 36%, P<0.0002), and worse QoL scores as assessed by the Short Form-12 (67 vs 52, P<0.00001), Psoriasis Quality of Life-12 questionnaire (62 vs 71, P<0.01), and Routine Assessment of Patient Index Data 3 (2.3 vs 4.7, P<0.01). Strikingly, 49% of patients with PsO had never received any systemic therapy. Conclusion These data highlight that PsO has marked negative impacts on QoL, while those patients with concomitant PsA are affected to a much greater degree. Despite large numbers of patients presenting with moderate-to-severe disease, use of systemic therapy for both PsO and PsA was uncommon. PMID:26622188

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

Murugesan, Sugeerth; Bouchard, Kristofer; Chang, Edward

There exists a need for effective and easy-to-use software tools supporting the analysis of complex Electrocorticography (ECoG) data. Understanding how epileptic seizures develop or identifying diagnostic indicators for neurological diseases require the in-depth analysis of neural activity data from ECoG. Such data is multi-scale and is of high spatio-temporal resolution. Comprehensive analysis of this data should be supported by interactive visual analysis methods that allow a scientist to understand functional patterns at varying levels of granularity and comprehend its time-varying behavior. We introduce a novel multi-scale visual analysis system, ECoG ClusterFlow, for the detailed exploration of ECoG data. Our systemmore » detects and visualizes dynamic high-level structures, such as communities, derived from the time-varying connectivity network. The system supports two major views: 1) an overview summarizing the evolution of clusters over time and 2) an electrode view using hierarchical glyph-based design to visualize the propagation of clusters in their spatial, anatomical context. We present case studies that were performed in collaboration with neuroscientists and neurosurgeons using simulated and recorded epileptic seizure data to demonstrate our system's effectiveness. ECoG ClusterFlow supports the comparison of spatio-temporal patterns for specific time intervals and allows a user to utilize various clustering algorithms. Neuroscientists can identify the site of seizure genesis and its spatial progression during various the stages of a seizure. Our system serves as a fast and powerful means for the generation of preliminary hypotheses that can be used as a basis for subsequent application of rigorous statistical methods, with the ultimate goal being the clinical treatment of epileptogenic zones.« less

Detection of Error Related Neuronal Responses Recorded by Electrocorticography in Humans during Continuous Movements

PubMed Central

Milekovic, Tomislav; Ball, Tonio; Schulze-Bonhage, Andreas; Aertsen, Ad; Mehring, Carsten

2013-01-01

Background Brain-machine interfaces (BMIs) can translate the neuronal activity underlying a user’s movement intention into movements of an artificial effector. In spite of continuous improvements, errors in movement decoding are still a major problem of current BMI systems. If the difference between the decoded and intended movements becomes noticeable, it may lead to an execution error. Outcome errors, where subjects fail to reach a certain movement goal, are also present during online BMI operation. Detecting such errors can be beneficial for BMI operation: (i) errors can be corrected online after being detected and (ii) adaptive BMI decoding algorithm can be updated to make fewer errors in the future. Methodology/Principal Findings Here, we show that error events can be detected from human electrocorticography (ECoG) during a continuous task with high precision, given a temporal tolerance of 300–400 milliseconds. We quantified the error detection accuracy and showed that, using only a small subset of 2×2 ECoG electrodes, 82% of detection information for outcome error and 74% of detection information for execution error available from all ECoG electrodes could be retained. Conclusions/Significance The error detection method presented here could be used to correct errors made during BMI operation or to adapt a BMI algorithm to make fewer errors in the future. Furthermore, our results indicate that smaller ECoG implant could be used for error detection. Reducing the size of an ECoG electrode implant used for BMI decoding and error detection could significantly reduce the medical risk of implantation. PMID:23383315

Rapid online language mapping with electrocorticography.

PubMed

Miller, Kai J; Abel, Taylor J; Hebb, Adam O; Ojemann, Jeffrey G

2011-05-01

Emerging research in evoked broadband electrocorticographic (ECoG) measurement from the cortical surface suggests that it might cleanly delineate the functional organization of cortex. The authors sought to demonstrate whether this could be done in a same-session, online manner to identify receptive and expressive language areas. The authors assessed the efficacy of simple integration of "χ-band" (76-200 Hz) change in the ECoG signal by implementing a simple band-pass filter to estimate broadband spectral change. Following a brief (less than 10-second) period to characterize baseline activity, χ-band activity was integrated while 7 epileptic patients with implanted ECoG electrodes performed a verb-generation task. While the patients were performing verb-generation or noun-reading tasks, cortical activation was consistently identified in primary mouth motor area, superior temporal gyrus, and Broca and Wernicke association areas. Maps were robust after a mean time of 47 seconds (using an "activation overlap" measure). Correlation with electrocortical stimulation was not complete and was stronger for noun reading than verb generation. Broadband ECoG changes can be captured online to identify eloquent cortex. This demonstrates the existence of a powerful new tool for functional mapping in the operative and chronic implant setting.

Wireless opto-electro neural interface for experiments with small freely behaving animals.

PubMed

Jia, Yaoyao; Khan, Wasif; Lee, Byunghun; Fan, Bin; Madi, Fatma; Weber, Arthur; Li, Wen; Ghovanloo, Maysam

2018-05-25

We have developed a wireless opto-electro interface (WOENI) device, which combines electrocorticogram (ECoG) recording and optical stimulation for bi-directional neuromodulation on small, freely behaving animals, such as rodents. The device is comprised of two components, a detachable headstage and an implantable polyimide-based substrate. The headstage establishes a Bluetooth Low Energy (BLE) bi-directional data communication with an external custom-designed USB dongle for receiving user commands and optogenetic stimulation patterns, and sending digitalized ECoG data. The functionality and stability of the device were evaluated in vivo on freely behaving rats. When the animal received optical stimulation on the primary visual cortex (V1) and visual stimulation via eyes, spontaneous changes in ECoG signals were recorded from both left and right V1 during 4 consecutive experiments with 7-day intervals over a time span of 21 days following device implantation. Immunostained tissue analyses showed results consistent with ECoG analyses, validating the efficacy of optical stimulation to upregulate the activity of cortical neurons expressing ChR2. The proposed WOENI device is potentially a versatile tool in the studies that involve long-term optogenetic neuromodulation. © 2018 IOP Publishing Ltd.

Decoding of motor intentions from epidural ECoG recordings in severely paralyzed chronic stroke patients

NASA Astrophysics Data System (ADS)

Spüler, M.; Walter, A.; Ramos-Murguialday, A.; Naros, G.; Birbaumer, N.; Gharabaghi, A.; Rosenstiel, W.; Bogdan, M.

2014-12-01

Objective. Recently, there have been several approaches to utilize a brain-computer interface (BCI) for rehabilitation with stroke patients or as an assistive device for the paralyzed. In this study we investigated whether up to seven different hand movement intentions can be decoded from epidural electrocorticography (ECoG) in chronic stroke patients. Approach. In a screening session we recorded epidural ECoG data over the ipsilesional motor cortex from four chronic stroke patients who had no residual hand movement. Data was analyzed offline using a support vector machine (SVM) to decode different movement intentions. Main results. We showed that up to seven hand movement intentions can be decoded with an average accuracy of 61% (chance level 15.6%). When reducing the number of classes, average accuracies up to 88% can be achieved for decoding three different movement intentions. Significance. The findings suggest that ipsilesional epidural ECoG can be used as a viable control signal for BCI-driven neuroprosthesis. Although patients showed no sign of residual hand movement, brain activity at the ipsilesional motor cortex still shows enough intention-related activity to decode different movement intentions with sufficient accuracy.

Scoring of anatomic injury after trauma: AIS 98 versus AIS 90--do the changes affect overall severity assessment?

PubMed

Skaga, Nils O; Eken, Torsten; Hestnes, Morten; Jones, J Mary; Steen, Petter A

2007-01-01

Although several changes were implemented in the 1998 update of the abbreviated injury scale (AIS 98) versus the previous AIS 90, both are still used worldwide for coding of anatomic injury in trauma. This could possibly invalidate comparisons between systems using different AIS versions. Our aim was to evaluate whether the use of different coding dictionaries affected estimation of Injury Severity Score (ISS), New Injury Severity Score (NISS) and probability of survival (Ps) according to TRISS in a hospital-based trauma registry. In a prospective study including 1654 patients from Ulleval University Hospital, a Norwegian trauma referral centre, patients were coded according to both AIS 98 and AIS 90. Agreement between the classifications of ISS, NISS and Ps according to TRISS methodology was estimated using intraclass correlation coefficients (ICC) with 95% CI. ISS changed for 378 of 1654 patients analysed (22.9%). One hundred and forty seven (8.9%) were coded differently due to different injury descriptions and 369 patients (22.3%) had a change in ISS value in one or more regions due to the different scoring algorithm for skin injuries introduced in AIS 98. This gave a minimal change in mean ISS (14.74 versus 14.54). An ICC value of 0.997 (95% CI 0.9968-0.9974) for ISS indicates excellent agreement between the scoring systems. There were no significant changes in NISS and Ps. There was excellent agreement for the overall population between ISS, NISS and Ps values obtained using AIS 90 and AIS 98 for injury coding. Injury descriptions for hypothermia were re-introduced in the recently published AIS 2005. We support this change as coding differences due to hypothermia were encountered in 4.3% of patients in the present study.

Comparison of Muscle Recovery Following Bi-cruciate Substituting versus Posterior Stabilized Total Knee Arthroplasty in the Asian Population.

PubMed

Takubo, Akihito; Ryu, Keinosuke; Iriuchishima, Takanori; Tokuhashi, Yasuaki

2017-09-01

The purpose of this study was to compare muscle recovery in the lower extremities following the newly developed bi-cruciate substituting (BCS) to posterior stabilized (PS) total knee arthroplasty (TKA) in the Asian population. Forty-one knees in 41 patients undergoing BCS-TKA (41 female, average age: 71 ± 8.8) and 34 knees in 34 patients undergoing PS-TKA (33 female, average age: 73 ± 7.2) were included in this study. The maximum isometric power of the quadriceps and hamstring muscles was measured preoperatively, and at 1, 3, 6, and 12 months after surgery using a handheld dynamometer. Postoperative muscle recovery was calculated regarding preoperative muscle power as 100%. Pre- and postoperative range of knee motion, femorotibial angle, and clinical scores (Knee Society score and function score) were also compared. No significant difference in sex, age, preoperative quadriceps, or preoperative hamstring power was observed between the BCS and PS-TKA groups. When regarding the preoperative muscle power as 100%, quadriceps power at 1, 3, 6, and 12 months following BCS-TKA was 61.2 ± 22%, 86.3 ± 28.3%, 97 ± 27.4%, and 112.4 ± 30.8%, respectively. Quadriceps power at 1, 3, 6, and 12 months following PS-TKA was 72.4 ± 20.8%, 84 ± 16.9%, 95 ± 20.7%, and 110.8 ± 27%, respectively. Hamstring power at 1, 3, 6, and 12 months following BCS-TKA was 96.3 ± 30%, 111.4 ± 35%, 120 ± 37%, and 125 ± 31%, respectively. Hamstring power at 1, 3, 6, and 12 months following PS-TKA was 95 ± 25%, 112.4 ± 27%, 117 ± 38.5%, and 120.4 ± 18.5%, respectively. No significant difference in muscle power recovery was observed at 3 ( p  = 0.995), 6 ( p  = 0.944), and 12 ( p  = 0.917) months after surgery between the two groups. No significant difference of the clinical score was observed between the groups (Knee Society score: p  = 0.479, function score: p  = 0.342). No significant difference in muscle recovery and clinical score were observed between the BCS and PS-TKA groups. Longer follow-up is needed for the evaluation of efficacy of BCS-TKA in the Asian populations. Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.

Observational studies using propensity score analysis underestimated the effect sizes in critical care medicine.

PubMed

Zhang, Zhongheng; Ni, Hongying; Xu, Xiao

2014-08-01

Propensity score (PS) analysis has been increasingly used in critical care medicine; however, its validation has not been systematically investigated. The present study aimed to compare effect sizes in PS-based observational studies vs. randomized controlled trials (RCTs) (or meta-analysis of RCTs). Critical care observational studies using PS were systematically searched in PubMed from inception to April 2013. Identified PS-based studies were matched to one or more RCTs in terms of population, intervention, comparison, and outcome. The effect sizes of experimental treatments were compared for PS-based studies vs. RCTs (or meta-analysis of RCTs) with sign test. Furthermore, ratio of odds ratio (ROR) was calculated from the interaction term of treatment × study type in a logistic regression model. A ROR < 1 indicates greater benefit for experimental treatment in RCTs compared with PS-based studies. RORs of each comparison were pooled by using meta-analytic approach with random-effects model. A total of 20 PS-based studies were identified and matched to RCTs. Twelve of the 20 comparisons showed greater beneficial effect for experimental treatment in RCTs than that in PS-based studies (sign test P = 0.503). The difference was statistically significant in four comparisons. ROR can be calculated from 13 comparisons, of which four showed significantly greater beneficial effect for experimental treatment in RCTs. The pooled ROR was 0.71 (95% CI: 0.63, 0.79; P = 0.002), suggesting that RCTs (or meta-analysis of RCTs) were more likely to report beneficial effect for the experimental treatment than PS-based studies. The result remained unchanged in sensitivity analysis and meta-regression. In critical care literature, PS-based observational study is likely to report less beneficial effect of experimental treatment compared with RCTs (or meta-analysis of RCTs). Copyright © 2014 Elsevier Inc. All rights reserved.

TNF-α gene polymorphisms: association with disease susceptibility and response to anti-TNF-α treatment in psoriatic arthritis.

PubMed

Murdaca, Giuseppe; Gulli, Rossella; Spanò, Francesca; Lantieri, Francesca; Burlando, Martina; Parodi, Aurora; Mandich, Paola; Puppo, Francesco

2014-10-01

The tumor necrosis factor-α (TNF-α) gene has been proposed as a major candidate gene in psoriatic arthritis (PsA). TNF-α is a therapeutic target for patients responding poorly to conventional treatments. We investigated the role of single-nucleotide polymorphisms (SNPs) at positions -238, -308, and +489 of the TNF-α gene in the genetic susceptibility to PsA, in the severity of the disease, and, finally, in the response to TNF-α inhibitors (adalimumab, etanercept, or infliximab). Fifty-seven Caucasian PsA patients and 155 healthy matched controls were studied. The SNP +489 variant allele A was significantly associated with PsA susceptibility (P=0.0136) and severity of clinical (Psoriasis Area and Severity Index score, American College of Rheumatology criteria, Disease Activity Score 28, and Disability Index Health Assessment Questionnaire) and laboratory (C-reactive protein and erythrocyte sedimentation rate) parameters (P-values ranging from 0.016 to 2.908 × 10(-12)). The difference in severity was accounted for by the differences between the AA and GA genotypes with respect to the GG genotype. The SNP +489A allele shows a trend of association with the response to PsA treatment with etanercept. These findings suggest a role of the SNP +489A allele in the susceptibility and severity of PsA.

Within-Cluster and Across-Cluster Matching with Observational Multilevel Data

ERIC Educational Resources Information Center

Kim, Jee-Seon; Steiner, Peter M.; Hall, Courtney; Thoemmes, Felix

2013-01-01

When randomized experiments cannot be conducted in practice, propensity score (PS) techniques for matching treated and control units are frequently used for estimating causal treatment effects from observational data. Despite the popularity of PS techniques, they are not yet well studied for matching multilevel data where selection into treatment…

High prevalence of shoulder girdle muscles with myofascial trigger points in patients with shoulder pain

PubMed Central

2011-01-01

Background Shoulder pain is reported to be highly prevalent and tends to be recurrent or persistent despite medical treatment. The pathophysiological mechanisms of shoulder pain are poorly understood. Furthermore, there is little evidence supporting the effectiveness of current treatment protocols. Although myofascial trigger points (MTrPs) are rarely mentioned in relation to shoulder pain, they may present an alternative underlying mechanism, which would provide new treatment targets through MTrP inactivation. While previous research has demonstrated that trained physiotherapists can reliably identify MTrPs in patients with shoulder pain, the percentage of patients who actually have MTrPs remains unclear. The aim of this observational study was to assess the prevalence of muscles with MTrPs and the association between MTrPs and the severity of pain and functioning in patients with chronic non-traumatic unilateral shoulder pain. Methods An observational study was conducted. Subjects were recruited from patients participating in a controlled trial studying the effectiveness of physical therapy on patients with unilateral non-traumatic shoulder pain. Sociodemographic and patient-reported symptom scores, including the Disabilities of the Arm, Shoulder, and Hand (DASH) Questionnaire, and Visual Analogue Scales for Pain were compared with other studies. To test for differences in age, gender distribution, and education level between the current study population and the populations from Dutch shoulder studies, the one sample T-test was used. One observer examined all subjects (n = 72) for the presence of MTrPs. Frequency distributions, means, medians, standard deviations, and 95% confidence intervals were calculated for descriptive purposes. The Spearman's rank-order correlation (ρ) was used to test for association between variables. Results MTrPs were identified in all subjects. The median number of muscles with MTrPs per subject was 6 (active MTrPs) and 4 (latent MTrPs). Active MTrPs were most prevalent in the infraspinatus (77%) and the upper trapezius muscles (58%), whereas latent MTrPs were most prevalent in the teres major (49%) and anterior deltoid muscles (38%). The number of muscles with active MTrPs was only moderately correlated with the DASH score. Conclusion The prevalence of muscles containing active and latent MTrPs in a sample of patients with chronic non-traumatic shoulder pain was high. PMID:21711512

Lower neurocognitive function in U-2 pilots

PubMed Central

Tate, David F.; Wood, Joe; Sladky, John H.; McDonald, Kent; Sherman, Paul M.; Kawano, Elaine S.; Rowland, Laura M.; Patel, Beenish; Wright, Susan N.; Hong, Elliot; Rasmussen, Jennifer; Willis, Adam M.; Kochunov, Peter V.

2014-01-01

Objective: Determine whether United States Air Force (USAF) U-2 pilots (U2Ps) with occupational exposure to repeated hypobaria had lower neurocognitive performance compared to pilots without repeated hypobaric exposure and whether U2P neurocognitive performance correlated with white matter hyperintensity (WMH) burden. Methods: We collected Multidimensional Aptitude Battery–II (MAB-II) and MicroCog: Assessment of Cognitive Functioning (MicroCog) neurocognitive data on USAF U2Ps with a history of repeated occupational exposure to hypobaria and compared these with control data collected from USAF pilots (AFPs) without repeated hypobaric exposure (U2Ps/AFPs MAB-II 87/83; MicroCog 93/80). Additional comparisons were performed between U2Ps with high vs low WMH burden. Results: U2Ps with repeated hypobaric exposure had significantly lower scores than control pilots on reasoning/calculation (U2Ps/AFPs 99.4/106.5), memory (105.5/110.9), information processing accuracy (102.1/105.8), and general cognitive functioning (103.5/108.5). In addition, U2Ps with high whole-brain WMH count showed significantly lower scores on reasoning/calculation (high/low 96.8/104.1), memory (102.9/110.2), general cognitive functioning (101.5/107.2), and general cognitive proficiency (103.6/108.8) than U2Ps with low WMH burden (high/low WMH mean volume 0.213/0.003 cm3 and mean count 14.2/0.4). Conclusion: In these otherwise healthy, highly functioning individuals, pilots with occupational exposure to repeated hypobaria demonstrated lower neurocognitive performance, albeit demonstrable on only some tests, than pilots without repeated exposure. Furthermore, within the U2P population, higher WMH burden was associated with lower neurocognitive test performance. Hypobaric exposure may be a risk factor for subtle changes in neurocognition. PMID:25008397

Empirical and targeted therapy of candidemia with fluconazole versus echinocandins: a propensity score-derived analysis of a population-based, multicentre prospective cohort.

PubMed

López-Cortés, L E; Almirante, B; Cuenca-Estrella, M; Garnacho-Montero, J; Padilla, B; Puig-Asensio, M; Ruiz-Camps, I; Rodríguez-Baño, J

2016-08-01

We compared the clinical efficacy of fluconazole and echinocandins in the treatment of candidemia in real practice. The CANDIPOP study is a prospective, population-based cohort study on candidemia carried out between May 2010 and April 2011 in 29 Spanish hospitals. Using strict inclusion criteria, we separately compared the impact of empirical and targeted therapy with fluconazole or echinocandins on 30-day mortality. Cox regression, including a propensity score (PS) for receiving echinocandins, stratified analysis on the PS quartiles and PS-based matched analyses, were performed. The empirical and targeted therapy cohorts comprised 316 and 421 cases, respectively; 30-day mortality was 18.7% with fluconazole and 33.9% with echinocandins (p 0.02) in the empirical therapy group and 19.8% with fluconazole and 27.7% with echinocandins (p 0.06) in the targeted therapy group. Multivariate Cox regression analysis including PS showed that empirical therapy with fluconazole was associated with better prognosis (adjusted hazard ratio 0.38; 95% confidence interval 0.17-0.81; p 0.01); no differences were found within each PS quartile or in cases matched according to PS. Targeted therapy with fluconazole did not show a significant association with mortality in the Cox regression analysis (adjusted hazard ratio 0.77; 95% confidence interval 0.41-1.46; p 0.63), in the PS quartiles or in PS-matched cases. The results were similar among patients with severe sepsis and septic shock. Empirical or targeted treatment with fluconazole was not associated with increased 30-day mortality compared to echinocandins among adults with candidemia. Copyright © 2016 European Society of Clinical Microbiology and Infectious Diseases. Published by Elsevier Ltd. All rights reserved.

Confluence of depression and acute psychological stress among patients with stable coronary heart disease: effects on myocardial perfusion.

PubMed

Burg, Matthew M; Meadows, Judith; Shimbo, Daichi; Davidson, Karina W; Schwartz, Joseph E; Soufer, Robert

2014-10-30

Depression is prevalent in coronary heart disease (CHD) patients and increases risk for acute coronary syndrome (ACS) recurrence and mortality despite optimal medical care. The pathways underlying this risk remain elusive. Psychological stress (PS) can provoke impairment in myocardial perfusion and trigger ACS. A confluence of acute PS with depression might reveal coronary vascular mechanisms of risk. We tested whether depression increased risk for impaired myocardial perfusion during acute PS among patients with stable CHD. Patients (N=146) completed the Beck Depression Inventory-I (BDI-I), a measure of depression linked to recurrent ACS and post-ACS mortality, and underwent single-photon emission computed tomography myocardial perfusion imaging at rest and during acute PS. The likelihood of new/worsening impairment in myocardial perfusion from baseline to PS as a function of depression severity was tested. On the BDI-I, 41 patients scored in the normal range, 48 in the high normal range, and 57 in the depressed range previously linked to CHD prognosis. A BDI-I score in the depressed range was associated with a significantly greater likelihood of new/worsening impairment in myocardial perfusion from baseline to PS (odds ratio =2.89, 95% CI: 1.26 to 6.63, P=0.012). This remained significant in models controlling ACS recurrence/mortality risk factors and medications. There was no effect for selective serotonin reuptake inhibitor medications. Depressed patients with CHD are particularly susceptible to impairment in myocardial perfusion during PS. The confluence of PS with depression may contribute to a better understanding of the depression-associated risk for ACS recurrence and mortality. © 2014 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley Blackwell.

A PK-PD Model of Ketamine-Induced High-Frequency Oscillations

PubMed Central

Flores, Francisco J.; Ching, ShiNung; Hartnack, Katharine; Fath, Amanda B.; Purdon, Patrick L.; Wilson, Matthew A.; Brown, Emery N.

2017-01-01

Objective Ketamine is a widely used drug with clinical and research applications, and also known to be used as a recreational drug. Ketamine produces conspicuous changes in the electrocorticographic (ECoG) signals observed both in humans and rodents. In rodents, the intracranial ECoG displays a High-Frequency Oscillation (HFO) which power is modulated non-linearly by ketamine dose. Despite the widespread use of ketamine there is no model description of the relationship between the pharmacokinetic-pharmacodynamics (PK-PD) of ketamine and the observed HFO power. Approach In the present study, we developed a PK-PD model based on estimated ketamine concentration, its known pharmacological actions, and observed ECoG effects. The main pharmacological action of ketamine is antagonism of the NMDA receptor (NMDAR), which in rodents is accompanied by a high-frequency oscillation (HFO) observed in the ECoG. At high doses, however, ketamine also acts at non-NMDAR sites, produces loss of consciousness, and the transient disappearance of the HFO. We propose a two-compartment PK model that represents the concentration of ketamine, and a PD model based in opposing effects of the NMDAR and non-NMDAR actions on the HFO power. Main results We recorded ECoG from the cortex of rats after two doses of ketamine, and extracted the HFO power from the ECoG spectrograms. We fit the PK-PD model to the time course of the HFO power, and showed that the model reproduces the dose-dependent profile of the HFO power. The model provides good fits even in the presence of high variability in HFO power across animals. As expected, the model does not provide good fits to the HFO power after dosing the pure NMDAR antagonist MK-801. Significance Our study provides a simple model to relate the observed electrophysiological effects of ketamine to its actions at the molecular level at different concentrations. This will improve the study of ketamine and rodent models of schizophrenia to better understand the wide and divergent range of effects that ketamine has. PMID:26268223

Localizing ECoG electrodes on the cortical anatomy without post-implantation imaging

PubMed Central

Gupta, Disha; Hill, N. Jeremy; Adamo, Matthew A.; Ritaccio, Anthony; Schalk, Gerwin

2014-01-01

Introduction Electrocorticographic (ECoG) grids are placed subdurally on the cortex in people undergoing cortical resection to delineate eloquent cortex. ECoG signals have high spatial and temporal resolution and thus can be valuable for neuroscientific research. The value of these data is highest when they can be related to the cortical anatomy. Existing methods that establish this relationship rely either on post-implantation imaging using computed tomography (CT), magnetic resonance imaging (MRI) or X-Rays, or on intra-operative photographs. For research purposes, it is desirable to localize ECoG electrodes on the brain anatomy even when post-operative imaging is not available or when intra-operative photographs do not readily identify anatomical landmarks. Methods We developed a method to co-register ECoG electrodes to the underlying cortical anatomy using only a pre-operative MRI, a clinical neuronavigation device (such as BrainLab VectorVision), and fiducial markers. To validate our technique, we compared our results to data collected from six subjects who also had post-grid implantation imaging available. We compared the electrode coordinates obtained by our fiducial-based method to those obtained using existing methods, which are based on co-registering pre- and post-grid implantation images. Results Our fiducial-based method agreed with the MRI–CT method to within an average of 8.24 mm (mean, median = 7.10 mm) across 6 subjects in 3 dimensions. It showed an average discrepancy of 2.7 mm when compared to the results of the intra-operative photograph method in a 2D coordinate system. As this method does not require post-operative imaging such as CTs, our technique should prove useful for research in intra-operative single-stage surgery scenarios. To demonstrate the use of our method, we applied our method during real-time mapping of eloquent cortex during a single-stage surgery. The results demonstrated that our method can be applied intra-operatively in the absence of post-operative imaging to acquire ECoG signals that can be valuable for neuroscientific investigations. PMID:25379417

Localizing ECoG electrodes on the cortical anatomy without post-implantation imaging.

PubMed

Gupta, Disha; Hill, N Jeremy; Adamo, Matthew A; Ritaccio, Anthony; Schalk, Gerwin

2014-01-01

Electrocorticographic (ECoG) grids are placed subdurally on the cortex in people undergoing cortical resection to delineate eloquent cortex. ECoG signals have high spatial and temporal resolution and thus can be valuable for neuroscientific research. The value of these data is highest when they can be related to the cortical anatomy. Existing methods that establish this relationship rely either on post-implantation imaging using computed tomography (CT), magnetic resonance imaging (MRI) or X-Rays, or on intra-operative photographs. For research purposes, it is desirable to localize ECoG electrodes on the brain anatomy even when post-operative imaging is not available or when intra-operative photographs do not readily identify anatomical landmarks. We developed a method to co-register ECoG electrodes to the underlying cortical anatomy using only a pre-operative MRI, a clinical neuronavigation device (such as BrainLab VectorVision), and fiducial markers. To validate our technique, we compared our results to data collected from six subjects who also had post-grid implantation imaging available. We compared the electrode coordinates obtained by our fiducial-based method to those obtained using existing methods, which are based on co-registering pre- and post-grid implantation images. Our fiducial-based method agreed with the MRI-CT method to within an average of 8.24 mm (mean, median = 7.10 mm) across 6 subjects in 3 dimensions. It showed an average discrepancy of 2.7 mm when compared to the results of the intra-operative photograph method in a 2D coordinate system. As this method does not require post-operative imaging such as CTs, our technique should prove useful for research in intra-operative single-stage surgery scenarios. To demonstrate the use of our method, we applied our method during real-time mapping of eloquent cortex during a single-stage surgery. The results demonstrated that our method can be applied intra-operatively in the absence of post-operative imaging to acquire ECoG signals that can be valuable for neuroscientific investigations.

Disparity between ultrasound and clinical findings in psoriatic arthritis.

PubMed

Husic, Rusmir; Gretler, Judith; Felber, Anja; Graninger, Winfried B; Duftner, Christina; Hermann, Josef; Dejaco, Christian

2014-08-01

To investigate the association between psoriatic arthritis (PsA)-specific clinical composite scores and ultrasound-verified pathology as well as comparison of clinical and ultrasound definitions of remission. We performed a prospective study on 70 consecutive PsA patients. Clinical assessments included components of Disease Activity Index for Psoriatic Arthritis (DAPSA) and the Composite Psoriatic Disease Activity Index (CPDAI). Minimal disease activity (MDA) and the following remission criteria were applied: CPDAI joint, entheses and dactylitis domains (CPDAI-JED)=0, DAPSA≤3.3, Boolean's remission definition and physician-judged remission (rem-phys). B-mode and power Doppler (PD-) ultrasound findings were semiquantitatively scored at 68 joints (evaluating synovia, peritendinous tissue, tendons and bony changes) and 14 entheses. Ultrasound remission and minimal ultrasound disease activity (MUDA) were defined as PD-score=0 and PD-score ≤1, respectively, at joints, peritendinous tissue, tendons and entheses. DAPSA but not CPDAI correlated with B-mode and PD-synovitis. Ultrasound signs of enthesitis, dactylitis, tenosynovitis and perisynovitis were not linked with clinical composites. Clinical remission or MDA was observed in 15.7% to 47.1% of PsA patients. Ultrasound remission and MUDA were present in 4.3% and 20.0% of patients, respectively. Joint and tendon-related PD-scores were higher in patients with active versus inactive disease according to CPDAI-JED, DAPSA, Boolean's and rem-phys, whereas no difference was observed regarding enthesitis and perisynovitis. DAPSA≤3.3 (OR 3.9, p=0.049) and Boolean's definition (OR 4.6, p=0.03) were more useful to predict MUDA than other remission criteria. PsA-specific composite scores partially reflect ultrasound findings. DAPSA and Boolean's remission definitions better identify MUDA patients than other clinical criteria. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

Prognostic factors in patients with malignant pleural effusion: Is it possible to predict mortality in patients with good performance status?

PubMed

Abrao, Fernando Conrado; Peixoto, Renata D'Alpino; de Abreu, Igor Renato Louro Bruno; Janini, Maria Cláudia; Viana, Geisa Garcia; de Oliveira, Mariana Campello; Younes, Riad Naim

2016-04-01

The aim of this study was to identify predictors of mortality only in patients with malignant pleural effusion (MPE) showing good performance status which required pleural palliative procedures. All patients with MPE submitted to pleural palliative procedure were enrolled in a prospective study between 2013 and 2014. Patients with Eastern cooperative oncology group (ECOG) score zero, one, and two were considered with good performance status. The possible prognostic factors were tested for significance using the log-rank test (Kaplan-Meier method) and those with significance on univariate analysis were entered into a multivariable Cox model. A total of 64 patients were included in the analysis. Median follow-up time for surviving patients was 263 days. Median survival for the entire cohort was not reached yet. In the multivariate analysis, gastrointestinal primary site (P = 0.006), low albumin concentration in the pleural fluid (P = 0.017), and high serum NLR (P = 0.007) were associated with mortality. In our cohort of ECOG 0-2 patients with MPE submitted to pleural palliative procedures, gastrointestinal malignancy compared to other sites, low pleural fluid albumin and high NLR were significantly associated with mortality. The identification of these prognostic factors may assist the choice of the optimal palliative technique. J. Surg. Oncol. 2016;113:570-574. © 2016 Wiley Periodicals, Inc. © 2016 Wiley Periodicals, Inc.

Outcomes in 370 patients with mantle cell lymphoma treated with ibrutinib: a pooled analysis from three open-label studies.

PubMed

Rule, Simon; Dreyling, Martin; Goy, Andre; Hess, Georg; Auer, Rebecca; Kahl, Brad; Cavazos, Nora; Liu, Black; Yang, Shiyi; Clow, Fong; Goldberg, Jenna D; Beaupre, Darrin; Vermeulen, Jessica; Wildgust, Mark; Wang, Michael

2017-11-01

Ibrutinib is highly active in treating mantle cell lymphoma (MCL), an aggressive B-cell lymphoma. We pooled data from three ibrutinib studies to explore the impact of baseline patient characteristics on treatment response. Patients with relapsed/refractory MCL (n = 370) treated with ibrutinib had an objective response rate (ORR) of 66% (20% complete response; 46% partial response); median duration of response (DOR), progression-free survival (PFS) and overall survival (OS) were 18·6, 12·8 and 25·0 months, respectively. Univariate analyses showed patients with one versus >one prior line of therapy had longer OS. Multivariate analyses identified that one prior line of therapy affected PFS; Eastern Cooperative Oncology Group (ECOG) performance status, simplified MCL international prognostic index (sMIPI) score, bulky disease, and blastoid histology affected OS and PFS. Patients with blastoid versus non-blastoid histology had similar time to best response, but lower ORR, DOR, PFS and OS. OS and PFS were longer in patients with better sMIPI, patients with ECOG performance status 0-1, non-bulky disease and non-blastoid histology. Additionally, the proportion of patients with poor prognostic factors increased with increasing lines of therapy. Together, results suggest that patient outcomes following treatment failure with ibrutinib are related to the natural biological evolution of the disease. © 2017 John Wiley & Sons Ltd.

Gemcitabine and docetaxel in relapsed and unresectable high-grade osteosarcoma and spindle cell sarcoma of bone.

PubMed

Palmerini, E; Jones, R L; Marchesi, E; Paioli, A; Cesari, M; Longhi, A; Meazza, C; Coccoli, L; Fagioli, F; Asaftei, S; Grignani, G; Tamburini, A; Pollack, S M; Picci, P; Ferrari, S

2016-04-20

Few new compounds are available for relapsed osteosarcoma. We retrospectively evaluated the activity of gemcitabine (G) plus docetaxel (D) in patients with relapsed high-grade osteosarcoma and high-grade spindle cell sarcoma of bone (HGS). Patients receiving G 900 mg/m(2) d 1, 8; D 75 mg/m(2) d 8, every 21 days were eligible. Primary end-point: progression-free survival (PFS) at 4 months; secondary end-point: overall survival (OS) and response rate. Fifty-one patients were included, with a median age of 17 years (8-71), 26 (51%) were pediatric patients. GD line of treatment: 2nd in 14 patients, ≥3rd in 37. 25 (49%) patients had metastases limited to lungs, 26 (51%) multiple sites. 40 (78%) osteosarcoma, 11 (22%) HGS. Eight (16%) patients achieved surgical complete response (sCR2) after GD. Four-month PFS rate was 46%, and significantly better for patients with ECOG 0 (ECOG 0: 54% vs ECOG 1: 43% vs ECOG 2: 0%; p = 0.003), for patients undergoing metastasectomy after GD (sCR2 75% vs no-sCR2 40 %, p = 0.02) and for osteosarcoma (osteosarcoma 56% vs HGS 18%; p = 0.05), with no differences according to age, line of treatment, and pattern of metastases. Forty-six cases had RECIST measurable disease: 6 (13%) patients had a partial response (PR), 20 (43%) had stable disease (SD) and 20 (43%) had progressive disease (PD). The 1-year OS was 30%: 67% for PR, 54% for SD and 20% for PD (p = 0.005). GD is an active treatment for relapsed high-grade osteosarcoma, especially for ECOG 0 patients, and should be included in the therapeutic armamentarium of metastatic osteosarcoma.

Sleep-waking cycle in the cerveau isolé cat.

PubMed

Slósarska, M; Zernicki, B

1973-06-01

The experiments were performed on ten chronic low cerveau isolé cats: in eight cats the brain stem transection was prepontine and in two cats, intercollicular. The preparations survived from 24 to 3 days. During 24-36 hr sessions the ECoG activity was continuously recorded, and the ocular and ECoG components of the orienting reflexes to visual and olfactory stimuli were studied. 2. Three periods can be recognized in the recovery process of the low cerveau isolé cat. They are called acute, early chronic and late chronic stages. The acute stage lasts 1 day and the early chronic stage seems to last 3 weeks at least. During the acute stage the ability to desynchronize the EEG, either spontaneously or in response to sensory stimulations, is dramatically impaired and the pupils are fissurated. Thus the cat is comatous. 4. During the early chronic stage, although the ECoG synchronization-desynchronization cycle and the associated fissurated myosis-myosis cycle already exist, the episodes of ECoG desynchronization occupy only a small percentage of time and usually develop slowly. Visual and olfactory stimuli are often ineffective. Thus the cat is semicomatous. In the late chronic stage the sleep-waking cycle is present. The animal can be easily awakened by visual and olfactory stimuli. The intensity of the ECoG arousal to visual stimuli and the distribution of time between alert wakefulness, drowsiness, light synchronized sleep and deep synchronized sleep are similar to those in the chronic pretrigeminal cat. The recovery of the cerveau isolé seems to reach a steady level when the sleep-waking cycle becomes similar to that present in the chronic pretrigeminal cat. During the whole survival period the vertical following reflex is abortive.

Multi-scale visual analysis of time-varying electrocorticography data via clustering of brain regions

DOE PAGES

Murugesan, Sugeerth; Bouchard, Kristofer; Chang, Edward; ...

2017-06-06

There exists a need for effective and easy-to-use software tools supporting the analysis of complex Electrocorticography (ECoG) data. Understanding how epileptic seizures develop or identifying diagnostic indicators for neurological diseases require the in-depth analysis of neural activity data from ECoG. Such data is multi-scale and is of high spatio-temporal resolution. Comprehensive analysis of this data should be supported by interactive visual analysis methods that allow a scientist to understand functional patterns at varying levels of granularity and comprehend its time-varying behavior. We introduce a novel multi-scale visual analysis system, ECoG ClusterFlow, for the detailed exploration of ECoG data. Our systemmore » detects and visualizes dynamic high-level structures, such as communities, derived from the time-varying connectivity network. The system supports two major views: 1) an overview summarizing the evolution of clusters over time and 2) an electrode view using hierarchical glyph-based design to visualize the propagation of clusters in their spatial, anatomical context. We present case studies that were performed in collaboration with neuroscientists and neurosurgeons using simulated and recorded epileptic seizure data to demonstrate our system's effectiveness. ECoG ClusterFlow supports the comparison of spatio-temporal patterns for specific time intervals and allows a user to utilize various clustering algorithms. Neuroscientists can identify the site of seizure genesis and its spatial progression during various the stages of a seizure. Our system serves as a fast and powerful means for the generation of preliminary hypotheses that can be used as a basis for subsequent application of rigorous statistical methods, with the ultimate goal being the clinical treatment of epileptogenic zones.« less

The role of ECoG magnitude and phase in decoding position, velocity, and acceleration during continuous motor behavior

PubMed Central

Hammer, Jiri; Fischer, Jörg; Ruescher, Johanna; Schulze-Bonhage, Andreas; Aertsen, Ad; Ball, Tonio

2013-01-01

In neuronal population signals, including the electroencephalogram (EEG) and electrocorticogram (ECoG), the low-frequency component (LFC) is particularly informative about motor behavior and can be used for decoding movement parameters for brain-machine interface (BMI) applications. An idea previously expressed, but as of yet not quantitatively tested, is that it is the LFC phase that is the main source of decodable information. To test this issue, we analyzed human ECoG recorded during a game-like, one-dimensional, continuous motor task with a novel decoding method suitable for unfolding magnitude and phase explicitly into a complex-valued, time-frequency signal representation, enabling quantification of the decodable information within the temporal, spatial and frequency domains and allowing disambiguation of the phase contribution from that of the spectral magnitude. The decoding accuracy based only on phase information was substantially (at least 2 fold) and significantly higher than that based only on magnitudes for position, velocity and acceleration. The frequency profile of movement-related information in the ECoG data matched well with the frequency profile expected when assuming a close time-domain correlate of movement velocity in the ECoG, e.g., a (noisy) “copy” of hand velocity. No such match was observed with the frequency profiles expected when assuming a copy of either hand position or acceleration. There was also no indication of additional magnitude-based mechanisms encoding movement information in the LFC range. Thus, our study contributes to elucidating the nature of the informative LFC of motor cortical population activity and may hence contribute to improve decoding strategies and BMI performance. PMID:24198757

[Effects of Feiji decoction for soothing the liver combined with psychotherapy on quality of life in primary lung cancer patients].

PubMed

Yao, Yilin

2012-01-01

Primary lung cancer is one of the most common malignant tumors. It causes great pain and mood disorders to patients, and significantly reduces their quality of life. The aim of the current study is to evaluate the effect of Feiji Decoction for soothing the liver combined with psychotherapy on quality of life (QoL) and physical status of patients with primary lung cancer. A total of 118 patients with primary non-small cell lung cancer were randomly divided into two groups. The 57 patients in the combined therapy group were treated with Feiji Decoction for soothing the liver and psychotherapy combined with chemotherapy, whereas the 61 patients in the control group were treated with chemotherapy only. Both groups were observed for the two treatment courses. The European Organization for Research and Treatment of Cancer QoL Questionnaire LC-43 (EORTC QLQ-LC43) was used to assess the QoL of every patient in both groups before and after treatment scales. At the same time, physical status was assessed using the Karnofsky performance status (KPS) and East Cooperative Oncology Group performance status (ECOG). The scores of physiology function, role function, emotion function, cognize function, society function, and general health in the therapy group were higher than that of the control group. The therapy group also showed better QoL results than the contol group. Significant differences were observed between the two groups (P<0.01). Meanwhile, the scores of fatigue, vomit, pain, polypnea, insomnia, anorexia, constipation, and specific manifestation of lung cancer in the therapy group were obviously lower than that of the control group; more patients were observed to be relieved. Significant differences between the two groups were observed (P<0.01). The KPS and ECOG scores of the patients were observed to have improved and stabilized in the therapy group than that of the control group; the differences were statistically significant (P<0.01). Feiji Decoction for soothing the liver combined with psychotherapy can alleviate the clinical symptoms, elevate the physical status, and improve the QOL of patients with primary lung cancer. Thus, this therapy has a good clinical therapeutic effect.

[Influence of surgeon specialization upon the results of colon cancer surgery. Usefulness of propensity scores].

PubMed

Martínez-Ramos, D; Escrig-Sos, J; Miralles-Tena, J M; Rivadulla-Serrano, M I; Daroca-José, J M; Salvador Sanchís, J L

2008-07-01

surgeon influence on colorectal cancer surgery outcomes has been repeatedly studied in the scientific literature, but conclusions have been contradictory. Here we study whether surgeon specialization is a determinant factor for outcome in these patients. The importance of propensity scores (PS) in surgical research is also studied. a retrospective study was performed and medical records were reviewed for 236 patients who were intervened for colon cancer in Castellon General Hospital (Spain). Cases were divided into two groups (specialist and non-specialist surgeons), and both 5-year surveillance and disease free survival were compared. Comparisons were first made with no adjustments, and then subsequently using PS analysis. the initial (non-adjusted) analysis was clearly favourable for the specialist surgeon group (5-year surveillance, 64.3 vs. 79.3%, p = 0.028). After adjusting for PS no statistical significance was obtained. surgeon specialization had no significant impact on patient outcome after colon cancer surgery. Propensity score analysis is an important tool in the analysis of surgical non-randomized studies, particularly when events under scrutiny are rare.

Performing both propensity score and instrumental variable analyses in observational studies often leads to discrepant results: a systematic review.

PubMed

Laborde-Castérot, Hervé; Agrinier, Nelly; Thilly, Nathalie

2015-10-01

Propensity score (PS) and instrumental variable (IV) are analytical techniques used to adjust for confounding in observational research. More and more, they seem to be used simultaneously in studies evaluating health interventions. The present review aimed to analyze the agreement between PS and IV results in medical research published to date. Review of all published observational studies that evaluated a clinical intervention using simultaneously PS and IV analyses, as identified in MEDLINE and Web of Science. Thirty-seven studies, most of them published during the previous 5 years, reported 55 comparisons between results from PS and IV analyses. There was a slight/fair agreement between the methods [Cohen's kappa coefficient = 0.21 (95% confidence interval: 0.00, 0.41)]. In 23 cases (42%), results were nonsignificant for one method and significant for the other, and IV analysis results were nonsignificant in most situations (87%). Discrepancies are frequent between PS and IV analyses and can be interpreted in various ways. This suggests that researchers should carefully consider their analytical choices, and readers should be cautious when interpreting results, until further studies clarify the respective roles of the two methods in observational comparative effectiveness research. Copyright © 2015 Elsevier Inc. All rights reserved.

The “Dry-Run” Analysis: A Method for Evaluating Risk Scores for Confounding Control

PubMed Central

Wyss, Richard; Hansen, Ben B.; Ellis, Alan R.; Gagne, Joshua J.; Desai, Rishi J.; Glynn, Robert J.; Stürmer, Til

2017-01-01

Abstract A propensity score (PS) model's ability to control confounding can be assessed by evaluating covariate balance across exposure groups after PS adjustment. The optimal strategy for evaluating a disease risk score (DRS) model's ability to control confounding is less clear. DRS models cannot be evaluated through balance checks within the full population, and they are usually assessed through prediction diagnostics and goodness-of-fit tests. A proposed alternative is the “dry-run” analysis, which divides the unexposed population into “pseudo-exposed” and “pseudo-unexposed” groups so that differences on observed covariates resemble differences between the actual exposed and unexposed populations. With no exposure effect separating the pseudo-exposed and pseudo-unexposed groups, a DRS model is evaluated by its ability to retrieve an unconfounded null estimate after adjustment in this pseudo-population. We used simulations and an empirical example to compare traditional DRS performance metrics with the dry-run validation. In simulations, the dry run often improved assessment of confounding control, compared with the C statistic and goodness-of-fit tests. In the empirical example, PS and DRS matching gave similar results and showed good performance in terms of covariate balance (PS matching) and controlling confounding in the dry-run analysis (DRS matching). The dry-run analysis may prove useful in evaluating confounding control through DRS models. PMID:28338910

A Multi-Channel, Flex-Rigid ECoG Microelectrode Array for Visual Cortical Interfacing

PubMed Central

Tolstosheeva, Elena; Gordillo-González, Víctor; Biefeld, Volker; Kempen, Ludger; Mandon, Sunita; Kreiter, Andreas K.; Lang, Walter

2015-01-01

High-density electrocortical (ECoG) microelectrode arrays are promising signal-acquisition platforms for brain-computer interfaces envisioned, e.g., as high-performance communication solutions for paralyzed persons. We propose a multi-channel microelectrode array capable of recording ECoG field potentials with high spatial resolution. The proposed array is of a 150 mm2 total recording area; it has 124 circular electrodes (100, 300 and 500 μm in diameter) situated on the edges of concentric hexagons (min. 0.8 mm interdistance) and a skull-facing reference electrode (2.5 mm2 surface area). The array is processed as a free-standing device to enable monolithic integration of a rigid interposer, designed for soldering of fine-pitch SMD-connectors on a minimal assembly area. Electrochemical characterization revealed distinct impedance spectral bands for the 100, 300 and 500 μm-type electrodes, and for the array's own reference. Epidural recordings from the primary visual cortex (V1) of an awake Rhesus macaque showed natural electrophysiological signals and clear responses to standard visual stimulation. The ECoG electrodes of larger surface area recorded signals with greater spectral power in the gamma band, while the skull-facing reference electrode provided higher average gamma power spectral density (γPSD) than the common average referencing technique. PMID:25569757

Posterior cruciate-substituting total knee replacement recovers the flexion arc faster in the early postoperative period in knees with high varus deformity: a prospective randomized study.

PubMed

Öztürk, Alpaslan; Akalın, Yavuz; Çevik, Nazan; Otuzbir, Ali; Özkan, Yüksel; Dostabakan, Yasin

2016-07-01

Posterior cruciate retention (CR) and substitution (PS) has been controversial in knee replacement surgery. Satisfactory medium and long-term results have been reported in knees with and without deformity but there are limited studies about early functional comparison in terms of recovery of flexion arc, stair activity, walking ability and straight leg raising, especially, in early postoperative period in knees with deformity. Therefore, we aimed to compare the flexion arc in CR and PS knees in postoperative first year including early postoperative days prospectively. Consecutive patients with a deformity of >10° were included and allocated to CR and PS groups randomly. KSS and Feller-patella scores were recorded both preoperatively and postoperatively (1st, 2nd, 3rd and 12th months). Flexion and extension were measured both preoperatively and postoperatively (1st, 2nd, 3rd day and discharge day as well as 1st, 2nd, 3rd and 12th months). Visual analog scale (VAS) was recorded postoperatively at the 1st, 2nd, 3rd and discharge day and at 1st, 2nd, 3rd and 12th months. The walking ability, stair activity and straight leg raising were recorded. Patients were also examined at the last visit with minimum 7-year follow-up with KSS, Feller-patella and VAS scores. Their mean flexion arcs were measured and recorded. There were 61 TKR evaluated. KSS knee and function scores at the 3rd month and KSS Knee Score at 1st year were superior in PS knees (p = 0.029, p = 0.046, p = 0.026). Flexion arc was found larger on day 1, 2, 3 and discharge day, and at 1st, 2nd, 3rd and 12th month in PS group (p = 0.048, p = 0.002, p = 0.027, p = 0.043, p = 0.014, p = 0.003, p = 0.002, p = 0.018). Walking and stair activity showed no difference but straight leg raising was better in CR knees (p = 0.02). Mean flexion arc was larger in PS knees at the last visit after 7 years (119.0° ± 7.5° in PS and 113.8° ± 8.7° in CR, p = 0.02). There was no revision required in that time interval. The other parameters were similar between groups. PS knees gained active flexion arc faster and larger. But straight leg raising activity recovered early in CR knees. Both types of prosthesis produced satisfactory outcome. PS and CR TKRs can be performed with the same performance in osteoarthritic knees even with high varus deformity. Prospective Randomized Controlled Trial, Level II.

Processing speed, attention, and working memory after treatment for medulloblastoma: an international, prospective, and longitudinal study.

PubMed

Palmer, Shawna L; Armstrong, Carol; Onar-Thomas, Arzu; Wu, Shengjie; Wallace, Dana; Bonner, Melanie J; Schreiber, Jane; Swain, Michelle; Chapieski, Lynn; Mabbott, Donald; Knight, Sarah; Boyle, Robyn; Gajjar, Amar

2013-10-01

The current study prospectively examined processing speed (PS), broad attention (BA), and working memory (WM) ability of patients diagnosed with medulloblastoma over a 5-year period. The study included 126 patients, ages 3 to 21 years at diagnosis, enrolled onto a collaborative protocol for medulloblastoma. Patients were treated with postsurgical risk-adapted craniospinal irradiation (n = 36 high risk [HR]; n = 90 average risk) followed by four cycles of high-dose chemotherapy with stem-cell support. Patients completed 509 neuropsychological evaluations using the Woodcock-Johnson Tests of Cognitive Abilities Third Edition (median of three observations per patient). Linear mixed effects models revealed that younger age at diagnosis, HR classification, and higher baseline scores were significantly associated with poorer outcomes in PS. Patients treated as HR and those with higher baseline scores are estimated to have less favorable outcomes in WM and BA over time. Parent education and marital status were significantly associated with BA and WM baseline scores but not change over time. Of the three key domains, PS was estimated to have the lowest scores at 5 years after diagnosis. Identifying cognitive domains most vulnerable to decline should guide researchers who are aiming to develop efficacious cognitive intervention and rehabilitation programs, thereby improving the quality of survivorship for the pediatric medulloblastoma population.

Social support and quality of life in a group of cancer patients (Ankara, Turkey).

PubMed

Yilmaz, Mustafa Soner; Piyal, Birgül; Akdur, Recep

2017-06-12

Cancer has become an important public health challenge all around the world. Though the demographic and clinical features of cancer patients are well documented in Turkey, the establishment of social support networks has been somewhat neglected. The aim of the study was to assess cancer patients' perceived social support and quality of life characteristics. The Multidimensional Perceived Social Support Scale, European Organization of Research and Treatment of Cancer Quality of Life Questionnaire, and Turkish version of the EUROHIS measurements were obtained from the study group. Associations between the scores and sociodemographic variables of the patients were evaluated. Determination of the best predictors that affect social support perception scores was performed by multiple linear regression analysis. A total of 364 patients (217 females, 147 males) were analyzed. Regarding the mean scores of perceived social support, statistically significant differences were found between education, perceived economic status, and ECOG groups (P < 0.001). The best predictors that have an effect on perceived social support need to be studied in depth with further research.

Phosphatidylserine and caffeine attenuate postexercise mood disturbance and perception of fatigue in humans.

PubMed

Wells, Adam J; Hoffman, Jay R; Gonzalez, Adam M; Stout, Jeffrey R; Fragala, Maren S; Mangine, Gerald T; McCormack, William P; Jajtner, Adam R; Townsend, Jeremy R; Robinson, Edward H

2013-06-01

Phosphatidylserine (PS) may attenuate the adverse effects of physical fatigue. Therefore, we investigated the effects of a multi-ingredient supplement containing 400 mg/d PS and 100 mg/d caffeine (supplement [SUP]) for 2 weeks on measures of cognitive function (CF), reaction time (RT), and mood (MD) following an acute exercise stress. It is hypothesized that PS will maintain preexercise CF and RT scores, while attenuating postexercise fatigue. Participants completed 2 acute bouts of resistance exercise (T1 and T2) separated by 2-week ingestion of SUP or control (CON). Outcome measures were assessed pre- and postexercise. When collapsed across groups, a significant decrease in RT performance was seen in the 60-second reaction drill from pre- to postexercise at T1. All other RT tests were similar from pre- to postexercise at T1. Reaction time was not significantly changed by PS. When collapsed across groups, a significant increase in performance of the serial subtraction test was seen. A significant increase (8.9% and 7.1%) in the number of correct answers and a significant decrease (8.0% and 7.5%) in time to answer were seen from pre- to postworkout at T1 and T2, respectively. A significant increase in total MD score from pre- to postworkout was observed for CON but not for PS at T2. Phosphatidylserine significantly attenuated pre- to postexercise perception of fatigue compared to CON. Ingestion of SUP for 14 days appears to attenuate postexercise MD scores and perception of fatigue, but does not affect CF or RT, in recreationally trained individuals. Copyright © 2013 Elsevier Inc. All rights reserved.

Effects of psychosocial stimulation on improving home environment and child-rearing practices: results from a community-based trial among severely malnourished children in Bangladesh.

PubMed

Nahar, Baitun; Hossain, Md Iqbal; Hamadani, Jena D; Ahmed, Tahmeed; Grantham-McGregor, Sally; Persson, Lars-Ake

2012-08-07

Parenting programmes are effective in enhancing parenting practices and child development. This study evaluated the effects of a intervention with psychosocial stimulation (PS) on the quality of the home environment and mothers' child-rearing practices in a community-based trial with severely malnourished Bangladeshi children. Severely underweight children (n = 507), 6-24 months of age, were randomly assigned to five groups: PS; food supplementation (FS); PS + FS; clinic-control (CC); and, hospital-control (CH). PS included fortnightly follow-up visits for six months at community clinics where a play leader demonstrated play activities and gave education on child development and child rearing practices. FS comprised cereal-based supplements (150-300 kcal/day) for three months. All groups received medical care, micronutrient supplements and growth monitoring. Mothers were given the Home Observation for Measurement of the Environment (HOME) inventory and a questionnaire on parenting at baseline and after six months to assess the outcome. 322 children completed the study. After six months of intervention the PS + FS and PS groups benefitted in the total HOME score (depending on the comparison group, effect sizes varied from 0.66 to 0.33 SD) The PS + FS and PS groups also benefitted in two HOME subscales: maternal involvement (effect sizes: 0.8 to 0.55 SD) and play materials, (effect sizes: 0.46 to 0.6 SD), and child-rearing practices scores (effect size: 1.5 to 1.1 SD). The PS + FS group benefitted 4.0 points in total HOME score compared with CH, 4.8 points compared with CC and 4.5 points compared with FS (p < 0.001 for all). The PS group benefitted 2.4 points compared with CH (p = 0.035), 3.3 points compared with CC (p = 0.004), and 2.9 points compared with FS (p = 0.006). Child-rearing practice scores of the PS + FS group improved 7.7, 6.4 and 6.6 points and the PS group improved 8.5, 7.2 and 7.4 points more than CH, CC and FS, respectively (p < 0.001 for all). Child-rearing practices of mothers of severely malnourished children and the quality of their home environment can be improved through community-based psychosocial stimulation with or without food supplementation. This may be of importance to promote child development.

Cisplatin, fotemustine and whole-brain radiotherapy in non-small cell lung cancer patients with asymptomatic brain metastases: a multicenter phase II study of the Gruppo Oncologico Italia Meridionale (GOIM 2603).

PubMed

Galetta, D; Gebbia, V; Silvestris, N; Ferraù, F; Carrozza, F; Cigolari, S; Russo, P; Calista, F; Adamo, V; Colucci, G

2011-04-01

More than 50% of brain metastases (BMs) occur in advanced non-small cell lung cancer (NSCLC) patients. Untreated patients with BMs have a poor prognosis with a median survival of 2 months. In most cases BMs are multiple and their optimal therapy is whole-brain radiation therapy (WBRT). The role of systemic therapies for these patients is still a matter for investigation due to concerns about the ability of these drugs to cross the blood-brain barrier (BBB). Cisplatin (CDDP) remains the backbone for medical treatment of NSCLC and fotemustine (FTM) is a nitrosurea able to cross the BBB. Patients with advanced NSCLC, ECOG performance status (PS) 0-1 and multiple BMs not amenable to surgery or stereotactic radiotherapy were treated with 2 cycles of FTM 80 mg/m(2) days 1, 8 and CDDP 80 mg/m(2) day 1, every 3 weeks followed by WBRT 30 Gy (3 Gy daily in 10 fractions). Radiological restaging was performed before WBRT to assess the role of chemotherapy both for cranial and extracranial disease. Patients with disease control (DC: complete response plus partial response) received 4 more cycles. To assess the basic activities of daily living (ADL), the Barthel ADL Index was used to score patients' performance every 2 cycles. The trial design provides a two-step evaluation according to the optimal two-stage design of Simon. In the first phase 29 patients were enrolled in order to verify if this schedule showed more than 25% response rate both for cranial and extracranial disease. If so, enrollment added up to a total of 81 patients. After the first evaluation 4 out of 29 patients were excluded from the study (3 untreated/1 not included for administrative reasons). At the time of the planned interim analysis patient's characteristics were the following: median age 61 years (range 44-70), M/F = 16/9, adenocarcinoma 11, squamous 5, large cell 2, undefined NSCLC 7; PS 0/1 in 11/14 cases, median Barthel Index score was 20 [13-20]. Three (12%) partial responses were observed, 9 subjects (36%) with stable disease and 13 (52%) showing disease progression. These data did not satisfy the pre-planned hypothesis and the study was stopped. At the time of the first evaluation before WBRT 12/25 (48%) patients had a systemic DC in contrast with 15/25 (60%) patients with BMs DC. Chemotherapy was relatively well tolerated with a prevalence of asthenia as the most relevant specific toxicity while the haematological toxicity was mild. CDDP and FTM combined with WBRT do not represent a therapeutic option for patients with NSCLC. Therefore further studies to evaluate the combination of systemic treatments with WBRT are warranted. Copyright © 2010 Elsevier Ireland Ltd. All rights reserved.

Estimating Treatment Effects via Multilevel Matching within Homogenous Groups of Clusters

ERIC Educational Resources Information Center

Steiner, Peter M.; Kim, Jee-Seon

2015-01-01

Despite the popularity of propensity score (PS) techniques they are not yet well studied for matching multilevel data where selection into treatment takes place among level-one units within clusters. This paper suggests a PS matching strategy that tries to avoid the disadvantages of within- and across-cluster matching. The idea is to first…

Developing Validity Evidence for the Written Pediatric History and Physical Exam Evaluation Rubric.

PubMed

King, Marta A; Phillipi, Carrie A; Buchanan, Paula M; Lewin, Linda O

The written history and physical examination (H&P) is an underutilized source of medical trainee assessment. The authors describe development and validity evidence for the Pediatric History and Physical Exam Evaluation (P-HAPEE) rubric: a novel tool for evaluating written H&Ps. Using an iterative process, the authors drafted, revised, and implemented the 10-item rubric at 3 academic institutions in 2014. Eighteen attending physicians and 5 senior residents each scored 10 third-year medical student H&Ps. Inter-rater reliability (IRR) was determined using intraclass correlation coefficients. Cronbach α was used to report consistency and Spearman rank-order correlations to determine relationships between rubric items. Raters provided a global assessment, recorded time to review and score each H&P, and completed a rubric utility survey. Overall intraclass correlation was 0.85, indicating adequate IRR. Global assessment IRR was 0.89. IRR for low- and high-quality H&Ps was significantly greater than for medium-quality ones but did not differ on the basis of rater category (attending physician vs. senior resident), note format (electronic health record vs nonelectronic), or student diagnostic accuracy. Cronbach α was 0.93. The highest correlation between an individual item and total score was for assessments was 0.84; the highest interitem correlation was between assessment and differential diagnosis (0.78). Mean time to review and score an H&P was 16.3 minutes; residents took significantly longer than attending physicians. All raters described rubric utility as "good" or "very good" and endorsed continued use. The P-HAPEE rubric offers a novel, practical, reliable, and valid method for supervising physicians to assess pediatric written H&Ps. Copyright © 2016 Academic Pediatric Association. Published by Elsevier Inc. All rights reserved.

New Interleukins in Psoriasis and Psoriatic Arthritis Patients: The Possible Roles of Interleukin-33 to Interleukin-38 in Disease Activities and Bone Erosions.

PubMed

Li, Jiang; Liu, Lei; Rui, Wenlong; Li, Xiangyu; Xuan, Dandan; Zheng, Shucong; Yu, Yiyun; Zhang, Jiong; Kong, Ning; Zhu, Xiaoxia; Zou, Hejian; Wan, Weiguo; Xue, Yu

2017-01-01

New interleukins (ILs), especially members of IL-1 and IL-12 families, have recently been reported to be involved in the development and regulation of autoimmune and inflammatory diseases. In this study, we aimed to explore the impact of these new ILs in psoriasis (Ps) and psoriatic arthritis (PsA). Forty PsA patients, 20 Ps patients, and 20 healthy controls (HCs) were recruited. Blood samples were obtained for detecting the levels of ILs, IL-12/23p40, and tumor necrosis factor α (TNF-α). The severity of skin lesions was assessed by the Psoriasis Area and Severity Index (PASI). Arthritis activities of PsA patients were assessed by the PsA Joint Activity Index. For PsA patients, circulating osteoclastogenesis-related cytokines (osteoprotegerin and receptor activator of nuclear factor-κB ligand) and numbers of osteoclast precursors were evaluated. Radiographic features of affected joints in these patients were scored for erosion, joint-space narrowing, osteolysis, and new bone formation. Correlations among levels of these ILs, Ps, and PsA disease activities and bone erosions were studied. Ps and PsA patients had higher serum levels of TNF-α, IL-12/23p40, and IL-33. Serum levels of IL-34 and IL-35 were higher in PsA patients than in Ps patients and HCs. Patients with pustular Ps had higher serum levels of IL-36α and IL-38 than patients with Ps vulgaris or HCs. Increased serum levels of IL-36α were positively correlated with PASI. Certain ILs were elevated in the circulation of patients with Ps and PsA, which might contribute to the pathogenesis of skin lesions and arthritis. © 2017 S. Karger AG, Basel.

Prognostic impact of MYC protein expression in central nervous system diffuse large B-cell lymphoma: comparison with MYC rearrangement and MYC mRNA expression.

PubMed

Son, Seung-Myoung; Ha, Sang-Yun; Yoo, Hae-Yong; Oh, Dongryul; Kim, Seok-Jin; Kim, Won-Seog; Ko, Young-Hyeh

2017-01-01

The prognostic role of MYC has been well documented in non-central nervous system diffuse large B-cell lymphoma; however, it remains controversial in central nervous system diffuse large B-cell lymphoma. To investigate the prognostic value of MYC, we analyzed the MYC protein expression by immunohistochemistry, mRNA expression by RNA in situ hybridization, and gene status by fluorescence in situ hybridization in 74 cases of central nervous system diffuse large B-cell lymphoma. Moreover, we examined the correlation between MYC translocation, mRNA expression, and protein expression. The mean percentage of MYC immunopositive cells was 49%. Using a 44% cutoff value, 49 (66%) cases showed MYC protein overexpression. The result of mRNA in situ hybridization using the RNA scope technology was obtained using the H-scoring system; the median value was 34.2. Using the cutoff value of 63.5, 16 (22%) cases showed MYC mRNA overexpression. MYC gene rearrangement was detected in five out of 68 (7%) cases. MYC translocation showed no statistically significant correlation with mRNA expression; however, all MYC translocation-positive cases showed MYC protein overexpression, with a higher mean percentage of MYC protein expression than that of translocation-negative cases (78 vs 48%, P=0.001). The level of MYC mRNA expression was moderately correlated with the level of MYC protein expression (P<0.001). The mean percentage of MYC protein expression in the high MYC mRNA group was higher than that in the low MYC mRNA group (70 vs 47%, P<0.001). A univariate analysis showed that age over 60 years, Eastern Cooperative Oncology Group (ECOG) performance status ≥2 and MYC protein overexpression were significantly associated with an increased risk of death. MYC translocation and MYC mRNA expression had no prognostic significance. On multivariate analysis, MYC protein overexpression and ECOG score retained prognostic significance.

Control of a visual keyboard using an electrocorticographic brain-computer interface.

PubMed

Krusienski, Dean J; Shih, Jerry J

2011-05-01

Brain-computer interfaces (BCIs) are devices that enable severely disabled people to communicate and interact with their environments using their brain waves. Most studies investigating BCI in humans have used scalp EEG as the source of electrical signals and focused on motor control of prostheses or computer cursors on a screen. The authors hypothesize that the use of brain signals obtained directly from the cortical surface will more effectively control a communication/spelling task compared to scalp EEG. A total of 6 patients with medically intractable epilepsy were tested for the ability to control a visual keyboard using electrocorticographic (ECOG) signals. ECOG data collected during a P300 visual task paradigm were preprocessed and used to train a linear classifier to subsequently predict the intended target letters. The classifier was able to predict the intended target character at or near 100% accuracy using fewer than 15 stimulation sequences in 5 of the 6 people tested. ECOG data from electrodes outside the language cortex contributed to the classifier and enabled participants to write words on a visual keyboard. This is a novel finding because previous invasive BCI research in humans used signals exclusively from the motor cortex to control a computer cursor or prosthetic device. These results demonstrate that ECOG signals from electrodes both overlying and outside the language cortex can reliably control a visual keyboard to generate language output without voice or limb movements.

Electrocorticographic language mapping with a listening task consisting of alternating speech and music phrases.

PubMed

Mooij, Anne H; Huiskamp, Geertjan J M; Gosselaar, Peter H; Ferrier, Cyrille H

2016-02-01

Electrocorticographic (ECoG) mapping of high gamma activity induced by language tasks has been proposed as a more patient friendly alternative for electrocortical stimulation mapping (ESM), the gold standard in pre-surgical language mapping of epilepsy patients. However, ECoG mapping often reveals more language areas than considered critical with ESM. We investigated if critical language areas can be identified with a listening task consisting of speech and music phrases. Nine patients with implanted subdural grid electrodes listened to an audio fragment in which music and speech alternated. We analysed ECoG power in the 65-95 Hz band and obtained task-related activity patterns in electrodes over language areas. We compared the spatial distribution of sites that discriminated between listening to speech and music to ESM results using sensitivity and specificity calculations. Our listening task of alternating speech and music phrases had a low sensitivity (0.32) but a high specificity (0.95). The high specificity indicates that this test does indeed point to areas that are critical to language processing. Our test cannot replace ESM, but this short and simple task can give a reliable indication where to find critical language areas, better than ECoG mapping using language tasks alone. Copyright © 2015 International Federation of Clinical Neurophysiology. Published by Elsevier Ireland Ltd. All rights reserved.

Novel Applications of Ultrasound Technology to Visualize and Characterize Myofascial Trigger Points and Surrounding Soft Tissue

PubMed Central

Sikdar, Siddhartha; Shah, Jay P.; Gebreab, Tadesse; Yen, Ru-Huey; Gilliams, Elizabeth; Danoff, Jerome; Gerber, Lynn H.

2009-01-01

Objective Apply ultrasound (US) imaging techniques to better describe the characteristics of myofascial trigger points (MTrPs) and the immediately adjacent soft tissue. Design Descriptive (exploratory) study. Setting Biomedical research center. Participants 9 subjects meeting Travell and Simons’s criteria for MTrPs in a taut band in the upper trapezius. Interventions (None) Main Outcome Measures MTrPs were evaluated by 1) physical examination, 2) pressure algometry, and 3) three types of ultrasound imaging including grayscale (2D US), vibration sonoelastography (VSE), and Doppler. Methods Four sites in each patient were labeled based on physical examination as either active MTrP (spontaneously-painful, A-MTrP), latent MTrP (non-painful, L-MTrP), or normal myofascial tissue. US examination was performed on each subject by a team blinded to the physical findings. A 12-5 MHz US transducer was used. VSE was performed by color Doppler variance imaging while simultaneously inducing vibrations (~92Hz) with a handheld massage vibrator. Each site was assigned a tissue imaging score (TIS) as follows: 0 = uniform echogenicity and stiffness; 1 = focal hypoechoic region with stiff nodule; 2 = multiple hypoechoic regions with stiff nodules. Blood flow in the neighborhood of MTrPs was assessed using Doppler imaging. Each site was assigned a blood flow waveform score (BFS) as follows: 0 = normal arterial flow in muscle; 1 = elevated diastolic flow; 2 = high-resistance flow waveform with retrograde diastolic flow. Results MTrPs appeared as focal, hypoechoic regions on 2D US, indicating local changes in tissue echogenicity, and as focal regions of reduced vibration amplitude on VSE, indicating a localized stiff nodule. MTrPs were elliptical in shape, with a size of 0.16 ± 0.11 cm2. There were no significant differences in size between A-MTrPs and L-MTrPs. Sites containing MTrPs were more likely to have higher TIS compared to normal myofascial tissue (p<0.002). Small arteries (or enlarged arterioles) near A-MTrPs showed retrograde flow in diastole indicating a highly resistive vascular bed. A-MTrP sites were more likely to have higher BFS compared to L-MTrPs (p<0.021). Conclusions Preliminary findings show that, under the conditions of this investigation, US imaging techniques can be used to distinguish myofascial tissue containing MTrPs from normal myofascial tissue (lacking trigger points). Ultrasound enables visualization and some characterization of MTrPs and adjacent soft tissue. PMID:19887205

Association of passive smoking with caries and related salivary biomarkers in young children.

PubMed

Avşar, A; Darka, O; Topaloğlu, B; Bek, Y

2008-10-01

To investigate the association between passive smoking, as determined by salivary cotinine level, and caries, salivary pH, buffering capacity, flow rate and microbiological counts in young children. Ninety passive smokers (PS) with a mean age of 5.02 years and 90 healthy age-matched controls were included in this study. Family income, smoking habits of household members, parental education levels, child's tooth-brushing habit and child's daily dietary sugar exposure were recorded by questionnaire. Three categories were formed with respect to the number of cigarettes smoked. A dmft score was calculated according to the criteria recommended by the World Health Organization. The children were also investigated for stimulated salivary cotinine level, pH, flow rate, buffering capacity and salivary Streptococcus mutans and lactobacilli colonisation. There were no significant differences in tooth-brushing habit, sugar exposure, family income and parental education levels between the two groups (P>0.05). The mean cotinine level of the PS subjects was 1.58+/-4.3ng/ml. The dmft scores, and salivary S. mutans and lactobacilli colonisation in PS children were significantly higher than in the control subjects (P<0.05). Statistically significant decreases in salivary pH, flow rate and buffering capacity were found in the PS subjects (P<0.05). PS children are at increased risk of caries compared with control subjects.

Sleep Disturbance in Psoriatic Disease: Prevalence and Associated Factors.

PubMed

Wong, Ian T Y; Chandran, Vinod; Li, Suzanne; Gladman, Dafna D

2017-09-01

We aimed to determine the prevalence and quality of sleep in patients with psoriatic arthritis (PsA) and those with psoriasis without PsA (PsC) followed in the same center, to identify factors associated with sleep disturbance, and to compare findings to those of healthy controls (HC). The study included 113 PsA [ClASsification for Psoriatic ARthritis (CASPAR) criteria] and 62 PsC (PsA excluded by a rheumatologist) patients and 52 HC. Clinical variables were collected using a standard protocol. The sleep quality was evaluated using the Pittsburgh Sleep Quality Index (PSQI). Other patient-reported outcomes collected included the Health Assessment Questionnaire (HAQ), Dermatology Life Quality Index, EQ-5D, Medical Outcomes Study Short Form-36 survey, patient's global assessment, and the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-fatigue) scale. Statistical analyses included descriptive statistics, Wilcoxon rank-sum test, and linear regression. The prevalence of poor sleep quality was 84%, 69%, and 50% in PsA, PsC, and HC, respectively. Total PSQI score was higher in both patients with PsA and patients with PsC compared with HC (p < 0.01) and higher in patients with PsA compared to patients with PsC (p < 0.0001). EQ-5D anxiety component, EQ-5D final, and FACIT-fatigue were independently associated with worse PSQI in patients with PsC and those with PsA (p < 0.05). Actively inflamed (tender or swollen) joints are independently associated with worse PSQI in patients with PsA (p < 0.01). Patients with psoriatic disease have poor sleep quality. Poor sleep is associated with fatigue, anxiety, and lower EQ-5D. In patients with PsA, poor sleep is associated with active joint inflammation.

Commentary on "Comparison of abiraterone acetate versus ketoconazole in patients with metastatic castration resistant prostate cancer refractory to docetaxel." Peer A, Gottfried M, Sinibaldi V, Carducci MA, Eisenberger MA, Sella A, Leibowitz-Amit R, Berger R, Keizman D, Department of Oncology, Rambam Medical Center, Haifa, Israel.: Prostate 2014 Apr;74(4):433-40; doi:10.1002/pros.22765. [Epub 2013 Dec 11].

PubMed

Trump, Donald

2016-05-01

Abiraterone, a potent CYP 17 inhibitor, is standard treatment in docetaxel refractory, metastatic castrate resistant prostate cancer (mCRPC). However, in countries where abiraterone has not been approved yet, or for patients who cannot afford it, ketoconazole is used as an alternative CYP 17 inhibitor. Although preclinical data suggests that ketoconazole is a less potent inhibitor of CYP 17, there are limited clinical data comparing both agents. We aimed to compare the clinical effectiveness of abiraterone versus ketoconazole in docetaxel refractory mCRPC. Records from mCRPC patients treated with ketoconazole (international multicenter database, n = 162) were reviewed retrospectively. Twenty-six patients treated post docetaxel were individually matched by clinicopathologic factors to patients treated with abiraterone (national multicenter database, n = 140). We compared the PSA response, biochemical and radiological progression free survival (PFS), and overall survival (OS) between the groups. PFS and OS were determined by Cox regression. The groups were matched by Gleason score, pre-treatment disease extent, ECOG PS, pre-treatment risk category (Keizman, Oncologist 2012). Furthermore, they were balanced regarding other known confounding risk factors. In the groups of abiraterone versus ketoconazole, PSA response was 46% versus 19% (OR 4.3, P = 0.04), median biochemical PFS 7 versus 2 months (HR 1.54, P = 0.02), median radiological PFS 8 versus 2.5 months (HR 1.8, P = 0.043), median OS 19 versus 11 months (HR 0.53, P = 0.79), and treatment interruption d/t severe adverse events 8% (n = 2) versus 31% (n = 8) (OR 0.6, P = 0.023). In docetaxel refractory mCRPC, the outcome of abiraterone treatment may be superior to ketoconazole. Copyright © 2016 Elsevier Inc. All rights reserved.

Efficacy and safety of crizotinib among Chinese EML4-ALK-positive, advanced-stage non-small cell lung cancer patients.

PubMed

Cao, Yabing; Xiao, Guangli; Qiu, Xibin; Ye, Sheng; Lin, Tongyu

2014-01-01

We report the efficacy and safety of crizotinib treatment among Chinese patients with advanced-stage NSCLC. We retrospectively analyzed patients with EML4-ALK positive advanced NSCLC who were treated with crizotinib from May 2012 to Aug 2013. Baseline clinical parameters, treatment protocol, response to therapy and survival were noted. The primary goal was to evaluate the efficacy of crizotinib in patients who were previously treated patients or who had poor ECOG performance status (PS). Forty patients were evaluable for safety and efficacy. Median age was 43 years, 100% had adenocarcinoma and stage IV disease, and 42.5% were female. Six patients received frontline treatment with crizotinib, 17 patients had 1 prior treatment, and 17 patients had more than 2 lines of prior treatment. Patients received a median of 5 cycles of treatment (range 1-15 cycles). After the first cycle, 92.5% (37/40) patients archived partial remission (PR). At the end of the follow-up period, the overall PR rate was 70% (28/40), and progression of disease (PD) occurred in 30% of patients (12/40). The median PFS was 28 weeks (95% CI 15.4 to 40.5 weeks), and median OS was 40 weeks (95% CI 38.6 to 49.3 weeks). The most frequent treatment-related AEs were vomiting (47.5%), vision disorder (27.5%) and increased ALT/AST (42%); most toxicities were Grade 1/2. Observed treatment-related Grade 3/4 AEs included increased ALT/AST (10%) and vomiting (5%). The EML4-ALK fusion rate and number of prior chemotherapy cycles did not appear to significantly affect the efficacy of crizotinib. However, PS 0-2 patients had improved PFS (50 weeks vs. 24 weeks, p = 0.015). Crizotinib was safe, well-tolerated, and effective in Chinese patients with pre-treated ALK-rearranged NSCLC. QOL was improved and PS appears to have an effect on the efficacy of crizotinib, but prior treatment and ALK fusion rate do not.

Reporting and Guidelines in Propensity Score Analysis: A Systematic Review of Cancer and Cancer Surgical Studies.

PubMed

Yao, Xiaoxin I; Wang, Xiaofei; Speicher, Paul J; Hwang, E Shelley; Cheng, Perry; Harpole, David H; Berry, Mark F; Schrag, Deborah; Pang, Herbert H

2017-08-01

: Propensity score (PS) analysis is increasingly being used in observational studies, especially in some cancer studies where random assignment is not feasible. This systematic review evaluates the use and reporting quality of PS analysis in oncology studies. : We searched PubMed to identify the use of PS methods in cancer studies (CS) and cancer surgical studies (CSS) in major medical, cancer, and surgical journals over time and critically evaluated 33 CS published in top medical and cancer journals in 2014 and 2015 and 306 CSS published up to November 26, 2015, without earlier date limits. The quality of reporting in PS analysis was evaluated. It was also compared over time and among journals with differing impact factors. All statistical tests were two-sided. More than 50% of the publications with PS analysis from the past decade occurred within the past two years. Of the studies critically evaluated, a considerable proportion did not clearly provide the variables used to estimate PS (CS 12.1%, CSS 8.8%), incorrectly included non baseline variables (CS 3.4%, CSS 9.3%), neglected the comparison of baseline characteristics (CS 21.9%, CSS 15.6%), or did not report the matching algorithm utilized (CS 19.0%, CSS 36.1%). In CSS, the reporting of the matching algorithm improved in 2014 and 2015 ( P  = .04), and the reporting of variables used to estimate PS was better in top surgery journals ( P  = .008). However, there were no statistically significant differences for the inclusion of non baseline variables and reporting of comparability of baseline characteristics. The use of PS in cancer studies has dramatically increased recently, but there is substantial room for improvement in the quality of reporting even in top journals. Herein we have proposed reporting guidelines for PS analyses that are broadly applicable to different areas of medical research that will allow better evaluation and comparison across studies applying this approach. © The Author 2017. Published by Oxford University Press. All rights reserved. For Permissions, please e-mail: journals.permissions@oup.com.

Une validation de la forme abrégée de l’Échelle de provisions sociales : l’ÉPS-10 items

PubMed Central

Caron, Jean

2016-01-01

L’Échelle de provisions sociales-10 items (ÉPS-10) est une version abrégée de l’Échelle de provisions sociales (Social Provisions Scale) (Cutrona et Russell, 1987) validée en langue française sur une population québécoise (Caron, 1996) et qui permet de mesurer la disponibilité du soutien social. L’ÉPS-10 conserve cinq des six sous-échelles de l’ÉPS (l’attachement ; l’intégration sociale ; la confirmation de sa valeur ; l’aide matérielle et l’orientation), le besoin de se sentir utile et nécessaire ayant été exclu, et ne garde que les items formulés positivement, soit deux items par dimension du soutien. L’article présente la validation de l’EPS-10 sur un échantillon représentatif de 2433 personnes provenant de la population générale du sud-ouest de Montréal. Elle a une forte validité concomitante avec l’Échelle originelle de 24 items (ÉPS). Tous ces items sont fortement corrélés au score total et sa consistance interne est excellente. Des analyses de corrélation entre les sous-échelles et le score global et une analyse factorielle indiquent que l’ÉPS-10 conserve sa validité de construit. L’ÉPS-10 explique 14,1 % de la variance de la détresse psychologique et 25,4 % de la variance de la qualité de vie et conserve un pouvoir prédictif équivalent à l’ÉPS à 24 items. L’ensemble des analyses suggère que l’ÉPS-10 est un instrument fiable et valide pour mesurer la disponibilité du soutien social avec un temps d’administration réduit de moitié. Il s’avère un excellent choix pour les enquêtes épidémiologiques. PMID:24337002

Proceedings of the Seventh International Workshop on Advances in Electrocorticography

PubMed Central

Ritaccio, Anthony; Matsumoto, Riki; Morrell, Martha; Kamada, Kyousuke; Koubeissi, Mohamad; Poeppel, David; Lachaux, Jean-Philippe; Yanagisawa, Yakufumi; Hirata, Masayuki; Guger, Christoph; Schalk, Gerwin

2015-01-01

The Seventh International Workshop on Advances in Electrocorticography (ECoG) convened in Washington, DC, on November 13–14, 2014. Electrocorticography-based research continues to proliferate widely across basic science and clinical disciplines. The 2014 workshop highlighted advances in neurolinguistics, brain-computer interface, functional mapping, and seizure termination facilitated by advances in the recording and analysis of the ECoG signal. The following proceedings document is an attempt at summarizing the content of this past year’s successful multidisciplinary gathering. PMID:26322594

Psoriatic Arthritis Quality of Life questionnaire: translation, cultural adaptation and validation into Portuguese language.

PubMed

Barcelos, Anabela; Ambrósio, Catarina; Pereira da Silva, J A; McKenna, Stephen; Wilburn, Jeanette; Lopes Ferreira, Pedro

2018-02-01

Psoriatic arthritis (PsA) has a strong negative impact on the quality of life of patients. The Psoriatic Arthritis Quality of Life (PsAQoL) questionnaire is a disease-specific instrument developed to measure the quality of life in patients with PsA. The aims of this study were to culturally adapt the questionnaire for Portugal and evaluate its reliability and validity in patients with PsA. The original UK English version of the PsAQoL was translated into Portuguese by a bilingual and lay panel. Structured cognitive debriefing interviews were conducted with ten PsA patients. The Portuguese PsAQoL was subsequently applied to PsA patients followed at the Rheumatology Department of Centro Hospitalar do Baixo Vouga, E.P.E. To assess reproducibility, 30 patients with PsA completed the Portuguese PsAQoL on two occasions, 2 weeks apart. A larger sample was recruited to determine internal consistency and construct validity. The Nottingham Health Profile (NHP) was used as a comparator instrument. Translation and adaptation were successful. Cronbach´s alpha for the Portuguese version of the PsAQoL was 0.91 and the test-retest reliability was 0.93. The PsAQoL could distinguish between groups of patients defined by self-reported general health status, self-reported severity of PsA and flare of arthritis. There was a positive correlation between the total score of the PsAQoL and each of the sections of the NHP. The Portuguese version of the PsAQoL was found to be relevant, understandable and easy to complete, reliable and valid.

Syntheses of some α-cyclic tripeptides as potential inhibitors for HMG-CoA Reductase.

PubMed

Chakraborty, Subrata; Lin, Shih-Hung; Shiuan, David; Tai, Dar-Fu

2015-08-01

α-Cyclic tripeptides (CtPs) are the most rigid members of the cyclic peptide family. However, due to their synthetic difficulty, biological activity has remained undisclosed. The incorporation of side-chain-protected natural amino acids into functional CtPs was performed to explore the potential biological functions. Several novel CtPs that consist of protected serine (S(Bn)) and/or glutamate (E(OBn)) were prepared from corresponding linear tripeptides by chemical synthesis. There is a strong possibility for CtPs that contain 3 phenyl groups to correlate with atorvastatin structure. The binding effects in human HMG-CoA reductase (hHMGR) activities were first evaluated by molecular docking. High docking scores were received with these CtPs for enzyme. Therefore, enzymatic assays were carried out and the compound cyclo(S(Bn))3 was indeed able to moderately inhibit hHMGR (IC50 = 110 μM).

Similar Superior Patient-Reported Outcome Measures for Anterior and Posterolateral Approaches After Total Hip Arthroplasty: Postoperative Patient-Reported Outcome Measure Improvement After 3 months in 12,774 Primary Total Hip Arthroplasties Using the Anterior, Anterolateral, Straight Lateral, or Posterolateral Approach.

PubMed

Peters, Rinne M; van Beers, Loes W A H; van Steenbergen, Liza N; Wolkenfelt, Julius; Ettema, Harmen B; Ten Have, Bas L E F; Rijk, Paul C; Stevens, Martin; Bulstra, Sjoerd K; Poolman, Rudolf W; Zijlstra, Wierd P

2018-06-01

Patient-reported outcome measures (PROMs) are used to evaluate the outcome of total hip arthroplasty (THA). We determined the effect of surgical approach on PROMs after primary THA. All primary THAs, with registered preoperative and 3 months postoperative PROMs were selected from the Dutch Arthroplasty Register. Based on surgical approach, 4 groups were discerned: (direct) anterior, anterolateral, direct lateral, and posterolateral approaches. The following PROMs were recorded: Hip disability and Osteoarthritis Outcome Score Physical function Short form (HOOS-PS); Oxford Hip Score; EQ-5D index score; EQ-5D thermometer; and Numeric Rating Scale measuring pain, both active and in rest. The difference between preoperative and postoperative scores was calculated (delta-PROM) and used as primary outcome measure. Multivariable linear regression analysis was performed for comparisons. Cohen's d was calculated as measure of effect size. All examined 4 approaches resulted in a significant increase of PROMs after primary THA in the Netherlands (n = 12,274). The anterior and posterolateral approaches were associated with significantly more improvement in HOOS-PS scores compared with the anterolateral and direct lateral approaches. Furthermore, the posterolateral and anterior approaches showed greater improvement on Numeric Rating Scale pain scores compared with the anterolateral approach. No relevant differences in delta-PROM were seen between the anterior and posterolateral surgical approaches. Anterior and posterolateral surgical approaches showed more improvement in self-reported physical functioning (HOOS-PS) compared with anterolateral and direct lateral approaches in patients receiving a primary THA. However, clinical differences were only small. Copyright © 2018 Elsevier Inc. All rights reserved.

Validation of the CPS + EG Staging System for Disease-Specific Survival in Breast Cancer Patients Treated with Neoadjuvant Chemotherapy.

PubMed

Abdelsattar, Jad M; Al-Hilli, Zahraa; Hoskin, Tanya L; Heins, Courtney N; Boughey, Judy C

2016-10-01

CPS + EG staging, which incorporates estrogen receptor (ER) status and tumor grade with pretreatment clinical stage (CS) and post-treatment pathologic stage (PS), has been reported to have better correlation with outcome than classic TNM staging for patients treated with neoadjuvant chemotherapy (NAC). Our goal was to evaluate the performance of CPS + EG staging system in an external cohort treated with NAC. We reviewed patients with stages I-IIIC breast cancer treated with NAC and surgery at our institution between 1988 and 2014. ER status, Nottingham grade, treatment, American Joint Committee on Cancer (AJCC) CS before NAC and PS after NAC, and follow-up data were collected. The discrimination of CPS + EG and pathologic AJCC stage were assessed using area under the curve (AUC) for survival data. A total of 769 patients were analyzed with a median follow-up of 2.6 (range 0.0-19.4) years; 103 patients died of breast cancer. Overall, the 5-year breast cancer cause-specific survival was 81.5 % [95 % confidence interval (CI) 77.6-85.5]. The 5-year, cause-specific survival by CPS + EG score was 93.8 % score 0, 89.9 % score 1, 90.7 % score 2, 84.8 % score 3, 67.7 % score 4, and 43.4 % score 5/6. CPS + EG score was significantly associated with cause-specific survival (p < 0.001) with an AUC of 0.69 (95 % CI 0.62-0.77) at 5 years. This was higher than the AUC of 0.63 (95 % CI 0.56-0.70) for AJCC PS (p = 0.10). This study validates the CPS + EG staging system using Nottingham grade in an external cohort. Addition of tumor biology and treatment response shows promise in improving survival estimates for patients treated with NAC.

Teaching the Emergency Department Patient Experience: Needs Assessment from the CORD-EM Task Force.

PubMed

London, Kory S; Druck, Jeffrey; Silver, Matthew; Finefrock, Douglas

2017-01-01

Since the creation of Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) patient satisfaction (PS) scores, patient experience (PE) has become a metric that can profoundly affect the fiscal balance of hospital systems, reputation of entire departments and welfare of individual physicians. While government and hospital mandates demonstrate the prominence of PE as a quality measure, no such mandate exists for its education. The objective of this study was to determine the education and evaluation landscape for PE in categorical emergency medicine (EM) residencies. This was a prospective survey analysis of the Council of Emergency Medicine Residency Directors (CORD) membership. Program directors (PDs), assistant PDs and core faculty who are part of the CORD listserv were sent an email link to a brief, anonymous electronic survey. Respondents were asked their position in the residency, the name of their department, and questions regarding the presence and types of PS evaluative data and PE education they provide. We obtained 168 responses from 139 individual residencies, representing 72% of all categorical EM residencies. This survey found that only 27% of responding residencies provide PS data to their residents. Of those programs, 61% offer simulation scores, 39% provide third-party attending data on cases with resident participation, 37% provide third-party acquired data specifically about residents and 37% provide internally acquired quantitative data. Only 35% of residencies reported having any organized PE curricula. Of the programs that provide an organized PE curriculum, most offer multiple modalities; 96% provide didactic lectures, 49% small group sessions, 47% simulation sessions and 27% specifically use standardized patient encounters in their simulation sessions. The majority of categorical EM residencies do not provide either PS data or any organized PE curriculum. Those that do use a heterogeneous set of data collection modalities and educational techniques. American Osteopathic Association and Accreditation Council for Graduate Medical Education residencies show no significant differences in their resident PS data provision or formal curricula. Further work is needed to improve education given the high stakes of PS scores in the emergency physician's career.

Noninvasive Uterine Electromyography For Prediction of Preterm Delivery*

PubMed Central

UCOVNIK, Miha L; MANER, William L.; CHAMBLISS, Linda R.; BLUMRICK, Richard; BALDUCCI, James; NOVAK-ANTOLIC, Ziva; GARFIELD, Robert E.

2011-01-01

Objective Power spectrum (PS) of uterine electromyography (EMG) can identify true labor. EMG propagation velocity (PV) to diagnose labor has not been reported. The objective was to compare uterine EMG against current methods to predict preterm delivery. Study design EMG was recorded in 116 patients (preterm labor, n=20; preterm non-labor, n=68; term labor, n=22; term non-labor, n=6). Student’s t-test was used to compare EMG values for labor vs. non-labor (P<0.05 significant). Predictive values of EMG, Bishop-score, contractions on tocogram, and transvaginal cervical length were calculated using receiver-operator-characteristics analysis. Results PV was higher in preterm and term labor compared with non-labor (P<0.001). Combined PV and PS peak frequency predicted preterm delivery within 7 days with area-under-the-curve (AUC) = 0.96. Bishop score, contractions, and cervical length had AUC of 0.72, 0.67, and 0.54. Conclusions Uterine EMG PV and PS peak frequency more accurately identify true preterm labor than clinical methods. PMID:21145033

The clinicopathological and survival differences between never and ever smokers with non-small cell lung cancer.

PubMed

Muallaoglu, Sadik; Karadeniz, Cemile; Mertsoylu, Huseyin; Ayberk Besen, Ali; Sezer, Ahmet; Murat Sedef, Ali; Kose, Fatih; Ozyilkan, Ozgur

2014-01-01

Cigarette smoking was regarded as the most important carcinogenic factor of lung cancer, yet in recent years lung cancer in never-smokers is an increasingly prominent public health issue. The aim of this study was to assess the epidemiological and clinicopathological characteristics of never-smoker patients with non small cell lung cancer (NSCLC), focusing on clinical risk factors and survival. We retrospectively analyzed 290 NSCLC patients who presented between 2006 and 2011. Differences in clinical features and survival between never- and ever- smoker patients were analyzed. Student's t-test and Mann-Whitney U-test were used to assess the significance of the variables between the groups. Survival curves were calculated using Kaplan-Meier method. Hazard ratio (HR) for death and its 95% confidence interval (CI) were calculated by Cox regression analysis. There were 243 (83.8%) ever-smokers and 47 (16.2%) never-smokers. In never-smokers females predominated (80.9%) as well as patients with adenocarcinomas (78.7%). At the time of analysis 143 (49.3%) patients had died. The 5-year overall survival (OS) rates were not significantly different between never- and ever-smokers (p=0.410) . The median OS of all patients was 26 months (95% CI: 16.8-35.2). The median OS was 23 months (95% CI: 11.8- 34.2) for never-smokers and 30 months ∥95% CI: 19.7-40.3) for ever-smokers (p=0.410). Never-smokers tended to present with more advanced disease than ever-smokers (p<0.004) and also with more advanced age (p<0.001). The HR for death increased with poorer Eastern Cooperative Oncology Group ( ECOG ) performance status (PS) (ECOG 2=3), advanced stage (stage 3=4) and untreated patients. Slightly lower risk for death was registered in patients with adenocarcinoma vs those with squamous cell carcinoma (SCC). Although no difference in survival was seen, definite epidemiologic differences do exist between never- smokers and ever-smokers patients with NSCLC. Future efforts should focus on the underlying biological differences, and on identifying potential non-tobacco related risk factors in order to improve treatment strategies for these two groups of NSCLC patients.

Self-reported patient safety competence among Canadian medical students and postgraduate trainees: a cross-sectional survey.

PubMed

Doyle, Patricia; VanDenKerkhof, Elizabeth G; Edge, Dana S; Ginsburg, Liane; Goldstein, David H

2015-02-01

Quality and patient safety (PS) are critical components of medical education. This study reports on the self-reported PS competence of medical students and postgraduate trainees. The Health Professional Education in Patient Safety Survey was administered to medical students and postgraduate trainees in January 2012. PS dimension scores were compared across learning settings (classroom and clinical) and year in programme. Sixty-three percent (255/406) of medical students and 32% (141/436) of postgraduate trainees responded. In general, both groups were most confident in their learning of clinical safety skills (eg, hand hygiene) and least confident in learning about sociocultural aspects of safety (eg, understanding human factors). Medical students' confidence in most aspects of safety improved with years of training. For some of the more intangible dimensions (teamwork and culture), medical students in their final year had lower scores than students in earlier years. Thirty-eight percent of medical students felt they could approach someone engaging in unsafe practice, and the majority of medical students (85%) and postgraduate trainees (78%) agreed it was difficult to question authority. Our results suggest the need to improve the overall content, structure and integration of PS concepts in both classroom and clinical learning environments. Decreased confidence in sociocultural aspects of PS among medical students in the final year of training may indicate that culture in clinical settings negatively affects students' perceived PS competence. Alternatively, as medical students spend more time in the clinical setting, they may develop a clearer sense of what they do not know. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

[Clinical evaluation of bedridden patients with pneumonia receiving home health care].

PubMed

Fukuyama, Hajime; Ishida, Tadashi; Tachibana, Hiromasa; Iga, Chiya; Nakagawa, Hiroaki; Ito, Akihiro; Ubukata, Satoshi; Yoshioka, Hiroshige; Arita, Machiko; Hashimoto, Toru

2010-12-01

Pneumonia which develops in patients while living in their own home is categorized as community-acquired pneumonia (CAP), even if these patients are bedridden and receiving home health care. However, because of the differences in patient backgrounds, we speculated that the clinical outcomes and pathogens of bedridden patients with pneumonia who are receiving home health care would be different from those of CAP. We conducted a prospective study of patients with CAP who were hospitalized at our hospital from April 2007 through September 2009. We compared home health care bedridden pneumonia (performance status 4, PS4-CAP) with non-PS4-CAP in a total of 505 enrolled patients in this study. Among these, 66 had PS4-CAP, mostly associated with aspiration. Severity scores, mortality rate, recurrence rate and length of hospital stay of those with PS4-CAP were significantly higher than those with non-PS4-CAP. Drug resistant pathogens were more frequently isolated from patients with PS4-CAP than from those of non-PS4-CAP. The results of patients with PS4-CAP were in agreement with those of previous health care-associated pneumonia (HCAP) reports. The present study suggested home health care bedridden pneumonia should be categorized as HCAP, not CAP.

High Frequency of Chronic Bacterial and Non-Inflammatory Prostatitis in Infertile Patients with Prostatitis Syndrome Plus Irritable Bowel Syndrome

PubMed Central

Vicari, Enzo; La Vignera, Sandro; Arcoria, Domenico; Condorelli, Rosita; Vicari, Lucia O.; Castiglione, Roberto; Mangiameli, Andrea; Calogero, Aldo E.

2011-01-01

Background Although prostatitis syndrome (PS) and irritable bowel syndrome (IBS) are common disorders, information on the prevalence of IBS in infertile patients with PS is relatively scanty. Therefore, this study was undertaken to estimate the frequency of PS and IBS and to evaluate the prevalence of the various diagnostic categories of prostatitis. Methodology/Principal Findings This study enrolled 152 patients with PS, diagnosed by the NIH-Chronic Prostatitis Symptom Index (NIH-CPSI) in an andrological setting, and 204 patients with IBS, diagnosed according to the Rome III diagnostic criteria in a gastroenterological setting. The patients with PS were asked to fulfill the Rome III questionnaire for IBS, whereas patients with IBS were asked to complete the NIH-CPSI. The simultaneous presence of PS and IBS was observed in 30.2% and 31.8% of the patients screened by andrologists and gastroenterologists, respectively. Altogether, 111 patients had PS plus IBS (31.2%). They had a total NIH-CPSI and pain subscale scores significantly higher than patients with PS alone. Gastrointestinal symptoms in patients with PS plus IBS were similar to those reported by patients with IBS alone and significantly greater in patients with PS alone. Patients with PS plus IBS had a significantly higher frequency of chronic bacterial prostatitis (category II) and lower of non-inflammatory prostatitis (category IIIB), compared to patients with PS alone. The frequency of inflammatory prostatitis (category IIIA) resulted similar. Conclusions/Significance Prostatitis syndromes and IBS are frequently associated in patients with PS- or IBS-related symptoms. These patients have an increased prevalence of chronic bacterial and non-inflammatory prostatitis. PMID:21494624

Assessment of Postoperative Pain in Cats After Ovariectomy by Laparoscopy, Median Celiotomy, or Flank Laparotomy.

PubMed

Gauthier, Olivier; Holopherne-Doran, Delphine; Gendarme, Thalia; Chebroux, Alexandre; Thorin, Chantal; Tainturier, Daniel; Bencharif, Djemil

2015-07-01

To compare postoperative pain, duration of surgery, and duration of anesthesia for 3 methods of ovariectomy in cats: (1) conventional ventral median open approach (Midline), (2) right flank approach (Flank), and (3) median 2-portal laparoscopic procedure (Lap). Randomized, prospective clinical trial. Healthy, sexually intact female cats (n = 60). Cats were randomly assigned to 1 of 3 groups: Midline (n = 20), Flank (20), and Lap (20) were evaluated 1, 2, 4, 6, and 12 hours after endotracheal extubation. Postoperative pain was scored using the 4A-vet pain scale that combines a subjective numerical pain rating and objective scoring of physiologic and behavioral variables including the response to stimulation of the surgical site. Pain scores (PS) were compared between groups. There was a significant difference in the PS between groups. PS for Midline and Flank were not significantly different but were both significantly higher compared with Lap. Depending on time, 5-20% of the cats had intense postoperative pain in both Midline and Flank groups. None of the Lap cats had intense postoperative pain. Laparoscopic ovariectomy, although slower, appeared less painful compared with conventional ventral midline and flank ovariectomy. Postoperative pain did not differ significantly between midline and flank groups. © Copyright 2014 by The American College of Veterinary Surgeons.

Facial skin photo-aging and development of hyperpigmented spots from children to middle-aged Japanese woman.

PubMed

Takahashi, Y; Fukushima, Y; Kondo, K; Ichihashi, M

2017-11-01

Facial skin hyperpigmention caused by chronic sun exposure is a major skin complaint, however, its characteristics and influential factors are still limitedly known. A cross-sectional survey in healthy Japanese women aged from 6 to 62 years (n=169) was conducted using a facial image analyzer VISIA ™ for knowing onset age of hyperpigmented spot formation, its chronological changes, and influence of environmental factors. UV Pigmented Spot (PS) Score was positively correlated with age (R=.487, P=.000). Hyperpigmented spots appeared first around 18 years old in most subjects, and PS score remarkably increased at 20s then gradually increased by ages. The subjects with Skin Type I, one of the three grades of Japanese Skin Type (JST), whose melanin formation is genetically lower, showed higher PS score. A woman aged 31 years was subjected a weekly VISIA measurement for 2 years, and found no changes in the number, place, size and intensity of the pigment spots in this duration. Hyperpigmented spots developed in women over 20 years of age due to chronic sun exposure without sun protection during childhood and adolescent and it was stable afterwards, whose intensity was influenced by age and skin type. © 2017 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Prediction of acute pancreatitis risk based on PIP score in children with cystic fibrosis.

PubMed

Terlizzi, V; Tosco, A; Tomaiuolo, R; Sepe, A; Amato, N; Casale, A; Mercogliano, C; De Gregorio, F; Improta, F; Elce, A; Castaldo, G; Raia, V

2014-09-01

Currently no tools to predict risk of acute (AP) and recurrent pancreatitis (ARP) in children with cystic fibrosis (CF) are available. We assessed the prevalence of AP/ARP and tested the potential role of Pancreatic Insufficiency Prevalence (PIP) score in a cohort of children with CF. We identified two groups of children, on the basis of presence/absence of AP/ARP, who were compared for age at diagnosis, clinical features, genotypes and sweat chloride level. PIP score was calculated for each patient. 10/167 (5.9%) experienced at least one episode of AP during follow up; 10/10 were pancreatic sufficient (PS). Patients with AP/ARP showed a PIP score ≤0.25 more frequently (6/10) than patients without AP/ARP. The odds ratio (95% CI) of developing pancreatitis was 4.54 (1.22-16.92) for patients with PIP <0.25 when compared with those who have a PIP score >0.25 (p 0.0151). PIP score was correlated with sweat chloride test (p < 0.01). PIP score, PS status and normal/borderline sweat chloride levels could be applied to predict pancreatitis development in children with CF. ARP could lead to pancreatic insufficiency. Copyright © 2014 European Cystic Fibrosis Society. Published by Elsevier B.V. All rights reserved.

What have we learned from 100% success of press fit condylar rotating platform posterior stabilized knees?: A 5-10 years followup by a nondesigner.

PubMed

Vaidya, Shrinand V; Virani, Siddharth; Phunde, Rajendra; Mahajan, Abhishek

2016-01-01

Total joint arthroplasties of the hip and knee represent a remarkable feat of modern medicine in terms of reducing pain and restoring function to millions of patients afflicted with severe arthritis. Oftentimes, the performance and longevity of new implants and devices are based on limited data. This is the first study by a non-designer on the press fit condylar rotating platform posterior stabilized (PFC-RP-PS) design with 100' success. This has a relevance, vis-á -vis bias that one may have in terms of reproducibility of technique and funding from the manufacturer. We associate our excellent mid-term results to intra operative technical aspects and stringent intra operative exclusion criteria. Our study includes a cohort of 121 selected knees operated between January 2003 and October 2010. We used cemented, posterior stabilized (PS), mobile bearing (MB), and RP prosthesis from the same manufacturer in all these 121 knees. The patients were evaluated bi-annually with the calculation of their Knee Society Scores (KSS) and a radiological assessment for loosening/osteolysis. 120 knees were available for followup. The average Knee Society clinical and functional scores, respectively, were 27 points and 40 points preoperatively and 93 points and 95 points postoperatively. This indicates a mean increase of about 71' in the clinical score and about 58' in the functional score, which is statistically significant. The mean postoperative flexion was 124°, a mean increase of 23° from the preoperative flexion of 101°. There were no revisions (Kaplan--Meier survivorship of 100'). We feel durable and reproducible results of PFC-RP-PS design knees are very technique sensitive. The way ahead with the PFC-RP-PS knees looks promising when the exclusion criteria for this design are strictly met. Coming from a non-designer, this study acquires a higher degree of relevance without any designer's or manufacturer's bias.

Quality-of-life and performance status results from the phase III RAINBOW study of ramucirumab plus paclitaxel versus placebo plus paclitaxel in patients with previously treated gastric or gastroesophageal junction adenocarcinoma†

PubMed Central

Al-Batran, S.-E.; Van Cutsem, E.; Oh, S. C.; Bodoky, G.; Shimada, Y.; Hironaka, S.; Sugimoto, N.; Lipatov, O. N.; Kim, T.-Y.; Cunningham, D.; Rougier, P.; Muro, K.; Liepa, A. M.; Chandrawansa, K.; Emig, M.; Ohtsu, A.; Wilke, H.

2016-01-01

Background The phase III RAINBOW trial demonstrated that the addition of ramucirumab to paclitaxel improved overall survival, progression-free survival, and tumor response rate in fluoropyrimidine–platinum previously treated patients with advanced gastric/gastroesophageal junction (GEJ) adenocarcinoma. Here, we present results from quality-of-life (QoL) and performance status (PS) analyses. Patients and methods Patients with Eastern Cooperative Oncology Group PS of 0/1 were randomized to receive ramucirumab (8 mg/kg i.v.) or placebo on days 1 and 15 of a 4-week cycle, with both arms receiving paclitaxel (80 mg/m2) on days 1, 8, and 15. Patient-reported outcomes were assessed with the QoL/health status questionnaires EORTC QLQ-C30 and EQ-5D at baseline and 6-week intervals. PS was assessed at baseline and day 1 of every cycle. Time to deterioration (TtD) in each QLQ-C30 scale was defined as randomization to first worsening of ≥10 points (on 100-point scale) and TtD in PS was defined as first worsening to ≥2. Hazard ratios (HRs) for treatment effect were estimated using stratified Cox proportional hazards models. Results Of the 665 patients randomized, 650 (98%) provided baseline QLQ-C30 and EQ-5D data, and 560 (84%) also provided data from ≥1 postbaseline time point. Baseline scores for both instruments were similar between arms. Of the 15 QLQ-C30 scales, 14 had HR < 1, indicating similar or longer TtD in QoL for ramucirumab + paclitaxel. Treatment with ramucirumab + paclitaxel was also associated with a delay in TtD in PS to ≥2 (HR = 0.798, P = 0.0941). Alternate definitions of PS deterioration yielded similar results: PS ≥ 3 (HR = 0.656, P = 0.0508), deterioration by ≥1 PS level (HR = 0.802, P = 0.0444), and deterioration by ≥2 PS levels (HR = 0.608, P = 0.0063). EQ-5D scores were comparable between treatment arms, stable during treatment, and worsened at discontinuation. Conclusion In patients with previously treated advanced gastric/GEJ adenocarcinoma, addition of ramucirumab to paclitaxel prolonged overall survival while maintaining patient QoL with delayed symptom worsening and functional status deterioration. ClinicalTrials.gov NCT01170663. PMID:26747859

The salvage therapy in lung adenocarcinoma initially harbored susceptible EGFR mutation and acquired resistance occurred to the first-line gefitinib and second-line cytotoxic chemotherapy.

PubMed

Yang, Chih-Jen; Hung, Jen-Yu; Tsai, Ming-Ju; Wu, Kuan-Li; Liu, Ta-Chih; Chou, Shah-Hwa; Lee, Jui-Ying; Hsu, Jui-Sheng; Huang, Ming-Shyan; Chong, Inn-Wen

2017-05-10

Epidermal growth factor receptor-tyrosine kinase inhibitors (EGFR-TKIs) such as gefitinib can provide better efficacy and prolonged progression free survival (PFS) than cytotoxic chemotherapy for metastatic lung non-squamous cell carcinoma harboring susceptible EGFR mutations when used as first-line therapy. Cytotoxic chemotherapy is regarded as being the standard therapy to overcome acquired resistance to an initial EGFR TKI. However, there is currently no consensus on how best to treat patients who develop resistance to both an initial EGFR TKI and chemotherapy. We enrolled stage IV lung adenocarcinoma patients with an EGFR mutation and who had developed acquired resistance to gefitinib and cytotoxic chemotherapy from two university-affiliated hospitals in Taiwan from June 2011 to December 2014. Basic demographic data, included Eastern Cooperative Oncology Group (ECOG) performance status were collected, and the response rate, progression-free survival (PFS) and overall survival (OS) were analyzed. Two hundred and nine patients with mutated EGFR and who took gefitinib as the first-line therapy were identified in the study period, of whom 86 received second-line cytotoxic chemotherapy, and 60 who received third-line therapy were eligible for this study. The patients who received cytotoxic chemotherapy had a significantly higher disease control rate than those who received erlotinib (73% vs. 46%, p = 0.0363), however there were no significant differences in PFS (2.9 months vs. 3.1 months, p = 0.9049) and OS (8.9 months vs. 7.9 months, p = 0.4956). Platinum- or pemetrexed-based chemotherapy provided similar PFS and OS as others did. The only significant poor prognostic factors for OS were old age (≥65 years) (HR = 5.97 [2.65-13.44], p < 0.0001) and poor performance status (ECOG ≥2) (HR = 5.84 [2.61-13.09], p < 0.0001). Retreatment with an EGFR TKI is not inferior to cytotoxic chemotherapy when used as salvage therapy for patients with adenocarcinoma with an EGFR mutation, especially if a third-generation EGFR TKI is not available, or if the reason for resistance is unknown or is not related to the T790M mutation. Old age and poor ECOG score were both poor prognostic factors in the salvage therapy.

Microscopic mild focal cortical dysplasia in temporal lobe dual pathology: an electrocorticography study.

PubMed

Morales Chacón, L; Estupiñán, B; Lorigados Pedre, L; Trápaga Quincoses, O; García Maeso, I; Sanchez, A; Bender del Busto, J; Garcia, M E; Baez Martin, M; Zaldivar, M; Gómez, A; Orozco, S; Rocha Arrieta, L

2009-10-01

Associations between electrophysiological and histological findings might provide an insight into the epileptogenicity of mild focal cortical dysplasia (FCD) in patients with temporal lobe epilepsy (TLE) and a dual pathology. A total of 22 patients with pharmacoresistant TLE were included in the study, 16 of them with histologically confirmed hippocampal sclerosis (HS) associated with neocortical temporal mild Palmini Type-I FCD subtypes and 6 with HS. Intraoperative electrocorticography (ECoG) recordings were analysed for epileptiform discharge frequency and morphology. Associations between histological, and electrocorticography pattern findings in these patients were analysed. Electroclinical outcomes in these patients were also evaluated. Neocortical areas with mild Palmini Type-I FCD showed a significantly higher spike frequency (SF) recorded in the inferior temporal gyrus than those neocortical areas in patients with HS. There was a tendency to higher spike frequency and lower amplitude in neocortical areas with histopathologic subtype IB FCD in relation with IA during intraoperative ECoG. Post-SF excision and amplitude were significantly lower during neocortical post-excision intraoperative ECoG than during neocortical pre-excision recording. There was no difference found in the clinical outcome between patients with and without FCD. Intraoperative electrocorticographic interictal spike frequency recorded in the neocortical inferior temporal gyrus may help to characterize the histopathologic subtypes of mild Palmini Type-I FCD in patients with temporal lobe epilepsy (TLE) and a dual pathology. Our data support the epileptogenicity of neocortical mild FCD in TLE and assessments of ECoG patterns are relevant to determine the extent of the resection in these patients which can influence the electroclinical outcome.

In-Vivo Animation of Auditory-Language-Induced Gamma-Oscillations in Children with Intractable Focal Epilepsy

PubMed Central

Brown, Erik C.; Rothermel, Robert; Nishida, Masaaki; Juhász, Csaba; Muzik, Otto; Hoechstetter, Karsten; Sood, Sandeep; Chugani, Harry T.; Asano, Eishi

2008-01-01

We determined if high-frequency gamma-oscillations (50- to 150-Hz) were induced by simple auditory communication over the language network areas in children with focal epilepsy. Four children (ages: 7, 9, 10 and 16 years) with intractable left-hemispheric focal epilepsy underwent extraoperative electrocorticography (ECoG) as well as language mapping using neurostimulation and auditory-language-induced gamma-oscillations on ECoG. The audible communication was recorded concurrently and integrated with ECoG recording to allow for accurate time-lock upon ECoG analysis. In three children, who successfully completed the auditory-language task, high-frequency gamma-augmentation sequentially involved: i) the posterior superior temporal gyrus when listening to the question, ii) the posterior lateral temporal region and the posterior frontal region in the time interval between question completion and the patient’s vocalization, and iii) the pre- and post-central gyri immediately preceding and during the patient’s vocalization. The youngest child, with attention deficits, failed to cooperate during the auditory-language task, and high-frequency gamma-augmentation was noted only in the posterior superior temporal gyrus when audible questions were given. The size of language areas suggested by statistically-significant high-frequency gamma-augmentation was larger than that defined by neurostimulation. The present method can provide in-vivo imaging of electrophysiological activities over the language network areas during language processes. Further studies are warranted to determine whether recording of language-induced gamma-oscillations can supplement language mapping using neurostimulation in presurgical evaluation of children with focal epilepsy. PMID:18455440

Detailed spectral profile analysis of electrocorticograms during freezing against penicillin-induced epileptiform discharges in the anesthetized rat.

PubMed

Tokiwa, Tatsuji; Zimin, Lev; Inoue, Takao; Nomura, Sadahiro; Suzuki, Michiyasu; Yamakawa, Takeshi

2018-07-01

Cryosurgery is an alternative technique for minimally invasive treatment of lesions. We have recently examined cryosurgery for epilepsy in animal models, and found that penicillin G (PG)-induced epileptiform discharges (EDs) mostly vanished after freezing. However, EDs were provoked again after insufficient freezing. Inadequate freezing is not visually detectable during and just after freezing and is not predictable beforehand. To manage this problem, we examined whether intraoperative monitoring of electrocorticograms (ECoGs) can predict recurrence of EDs after cryosurgery. A palm-sized cryoprobe system was applied to focal seizures in a Wistar rat model in which EDs were induced in advance by intracerebral injection of PG. During stable induction of EDs, the cryoprobe was carefully inserted into the epileptic region and this region was immediately frozen. After the series of prefreezing, freezing, and postfreezing, rats in which PG-induced EDs relapsed within 3 h were defined as the ED-relapsed (EDR) group, and other rats were defined as the ED-vanished (EDV) group. Time-frequency analysis was conducted on the ECoGs in each group through each freezing series. Relapse of PG-induced EDs on ECoG after the freezing series was associated with the remaining power of the delta band in the freezing period more strongly in the EDR group than in the EDV group. Success or failure of the freezing procedure can be predicted by the specificity of the delta band of the ECoG obtained intraoperatively. Copyright © 2018 Elsevier B.V. All rights reserved.

Electrical Stimulation of the Left and Right Human Fusiform Gyrus Causes Different Effects in Conscious Face Perception

PubMed Central

Rangarajan, Vinitha; Hermes, Dora; Foster, Brett L.; Weiner, Kevin S.; Jacques, Corentin; Grill-Spector, Kalanit

2014-01-01

Neuroimaging and electrophysiological studies across species have confirmed bilateral face-selective responses in the ventral temporal cortex (VTC) and prosopagnosia is reported in patients with lesions in the VTC including the fusiform gyrus (FG). As imaging and electrophysiological studies provide correlative evidence, and brain lesions often comprise both white and gray matter structures beyond the FG, we designed the current study to explore the link between face-related electrophysiological responses in the FG and the causal effects of electrical stimulation of the left or right FG in face perception. We used a combination of electrocorticography (ECoG) and electrical brain stimulation (EBS) in 10 human subjects implanted with intracranial electrodes in either the left (5 participants, 30 FG sites) or right (5 participants, 26 FG sites) hemispheres. We identified FG sites with face-selective ECoG responses, and recorded perceptual reports during EBS of these sites. In line with existing literature, face-selective ECoG responses were present in both left and right FG sites. However, when the same sites were stimulated, we observed a striking difference between hemispheres. Only EBS of the right FG caused changes in the conscious perception of faces, whereas EBS of strongly face-selective regions in the left FG produced non-face-related visual changes, such as phosphenes. This study examines the relationship between correlative versus causal nature of ECoG and EBS, respectively, and provides important insight into the differential roles of the right versus left FG in conscious face perception. PMID:25232118

Bipolar electrocoagulation on cortex after AVMs lesionectomy for seizure control.

PubMed

Cao, Yong; Wang, Rong; Yang, Lijun; Bai, Qin; Wang, Shuo; Zhao, Jizong

2011-01-01

The findings of previous studies remain controversial on the optimal management required for effective seizure control after surgical excision of arteriovenous malformations (AVMs). We evaluated the efficacy of additional bipolar electrocoagulation on the electrically positive cortex guided by intraoperative electrocorticography (ECoG) for controlling cerebral AVMs-related epilepsy. Sixty consecutive patients with seizure due to cerebral AVMs, who underwent surgical excision of cerebral AVMs and intraoperative ECoG, were assessed. The AVMs and surrounding hemosiderin stained tissue were completely removed, and bipolar electrocoagulation was applied on the surrounding cerebral cortex where epileptic discharges were monitored via intraoperative ECoG. Patients were followed up at three to six months after the surgery and then annually. We evaluated seizure outcome by using Engel's classification and postoperative complications. Forty-nine patients (81.6%) were detected of epileptic discharges before and after AVMs excision. These patients underwent the removal of AVMs plus bipolar electrocoagulation on spike-positive site cortex. After electrocoagulation, 45 patients' epileptic discharges disappeared, while four obviously diminished. Fifty-five of 60 patients (91.7%) had follow-up lasting at least 22 months (mean 51.1 months; range 22-93 months). Determined by the Engel Seizure Outcome Scale, 39 patients (70.9%) were Class I, seven (12.7%) Class II, five (9.0%) Class III, and four (7.2%) Class IV. Even after the complete removal of AVM and surrounding gliotic and hemosiderin stained tissue, a high-frequency residual spike remained on the surrounding cerebral cortex. Effective surgical seizure control can be achieved by carrying out additional bipolar electrocoagulation on the cortex guided by the intraoperative ECoG.

Contextual Factors, Indoor Tanning, and Tanning Dependence in Young Women

PubMed Central

Heckman, Carolyn J.; Darlow, Susan D.; Kloss, Jacqueline D.; Munshi, Teja; Manne, Sharon L.

2015-01-01

Objectives The study's purpose was to investigate the association of contextual factors such as cost, tanning accessibility, regulations, or marketing and indoor tanning or tanning dependence. Methods One hundred thirty-nine college-aged female indoor tanners completed a questionnaire between 2009 and 2011. Results Higher scores on tanning dependence and assessment in the spring/summer (versus the fall/winter) were associated with more frequent indoor tanning in the last 30 days (ps < .05). More frequent indoor tanning, greater session length, and more trouble paying for tanning were associated with higher scores on tanning dependence (ps < .05). Conclusions Public health research and practice could benefit from attention to such contextual factors as tanning cost and regulations regarding session length. PMID:25741682

A retrospective study of the impact of 21-gene recurrence score assay on treatment choice in node positive micrometastatic breast cancer.

PubMed

Frazier, Thomas G; Fox, Kevin R; Smith, J Stanley; Laronga, Christine; McSwain, Anita; Paul, Devchand; Schultz, Michael; Stilwill, Joseph; Teal, Christine; Weisberg, Tracey; Vacchino, Judith F; Sing, Amy P; Cherepanov, Dasha; Hsiao, Wendy; Chang, Eunice; Broder, Michael S

2015-03-17

To assess clinical utility of the 21-gene assay (Oncotype DX® Recurrence Score®), we determined whether women with HER2(-)/ER+ pN1mi breast cancer with low (<18) Recurrence Scores results are given adjuvant chemotherapy in a lower proportion than those with high scores (≥31). This was a multicenter chart review of ≥18 year old women with pN1mi breast cancer, HER2(-)/ER+ tumors, ductal/lobular/mixed histology, with the assay ordered on or after 1 January 2007. One hundred and eighty one patients had a mean age of 60.7 years; 82.9% had ECOG performance status 0; 33.7% had hypertension, 22.7% had osteoporosis, 18.8% had osteoarthritis, and 8.8% had type-2 diabetes. Mean Recurrence Score was 17.8 (range: 0-50). 48.6% had a mastectomy; 55.8% had a lumpectomy. 19.8% of low-risk group patients were recommended chemotherapy vs. 57.9% in the intermediate-risk group and 100% in the high-risk group (p < 0.001). A total of 80.2% of the low-risk group were recommended endocrine therapy alone, while 77.8% of the high-risk group were recommended both endocrine and chemotherapy (p < 0.001). The Oncotype DX Recurrence Score result provides actionable information that can be incorporated into treatment planning for women with HER2(-)/ER+ pN1mi breast cancer. The Recurrence Score result has clinical utility in treatment planning for HER2(-)/ER+ pN1mi breast cancer patients.

Discriminant validity, responsiveness and reliability of the arthritis-specific Work Productivity Survey assessing workplace and household productivity in patients with psoriatic arthritis

PubMed Central

2014-01-01

Introduction The novel arthritis-specific Work Productivity Survey (WPS) was developed to estimate patient productivity limitations associated with arthritis within and outside the home, which is an unmet need in psoriatic arthritis (PsA). The WPS has been validated in rheumatoid arthritis. This report assesses the discriminant validity, responsiveness and reliability of the WPS in adult-onset PsA. Methods Psychometric properties were assessed using data from the RAPID-PsA trial (NCT01087788) investigating certolizumab pegol (CZP) efficacy and safety in PsA. WPS was completed at baseline and every 4 weeks until Week 24. Validity was evaluated at baseline via known-groups defined using first and third quartiles of patients’ Disease Activity Score 28 based on C-reactive protein (DAS28(CRP)), Health Assessment Questionnaire-Disability Index (HAQ-DI), Short Form-36 (SF-36) items and PsA Quality of Life (PsAQoL) scores. Responsiveness and reliability were assessed by comparing WPS mean changes at Week 12 in American College of Rheumatology 20% improvement criteria (ACR20) or HAQ-DI Minimal Clinically Important Difference (MCID) 0.3 responders versus non-responders, as well as using standardized response means (SRM). All comparisons were conducted on the observed cases in the Randomized Set, regardless of the randomization group, using a non-parametric bootstrap-t method. Results Compared with patients with a better health state, patients with a worse health state had on average 2 to 6 times more household work days lost, more days with reduced household productivity, more days missed of family/social/leisure activities, more days with outside help hired and a significantly higher interference of arthritis per month. Among employed patients, those with a worse health state had 2 to 4 times more workplace days lost, more days with patient workplace productivity reduced, and a significantly higher interference of arthritis on patient workplace productivity versus patients with a better health state. WPS was also responsive to clinical changes, with responders having significantly larger improvements at Week 12 in WPS scores versus non-responders. The effect sizes for changes in productivity in ACR20 or HAQ-DI MCID responders were moderate (0.5 < SRM < 0.8) or small. Conclusions These analyses demonstrate the validity, responsiveness and reliability of the WPS, as an instrument for the measurement of patient productivity within and outside the home in an adult-onset PsA population. PMID:24996416

Calprotectin and TNF trough serum levels identify power Doppler ultrasound synovitis in rheumatoid arthritis and psoriatic arthritis patients in remission or with low disease activity.

PubMed

Inciarte-Mundo, José; Ramirez, Julio; Hernández, Maria Victoria; Ruiz-Esquide, Virginia; Cuervo, Andrea; Cabrera-Villalba, Sonia Raquel; Pascal, Mariona; Yagüe, Jordi; Cañete, Juan D; Sanmarti, Raimon

2016-07-08

Serum levels of calprotectin, a major S100 leucocyte protein, are associated with disease activity in rheumatoid arthritis (RA) and psoriatic arthritis (PsA) patients. Higher drug trough serum levels are associated with good response in patients treated with tumour necrosis factor inhibitors (TNFi). Power Doppler ultrasound (PDUS) synovitis is predictive of flare and progression of structural damage in patients in clinical remission. The purpose of this study was to analyse the accuracy of calprotectin and TNFi trough serum levels in detecting PDUS synovitis in RA and PsA patients in clinical remission or with low disease activity who were receiving TNFi. We conducted a cross-sectional study of 92 patients (42 with RA, 50 with PsA) receiving adalimumab (ADA), etanercept (ETN) or infliximab who were in remission or had low disease activity (28-joint Disease Activity Score based on erythrocyte sedimentation rate <3.2). Associations of calprotectin, TNFi trough serum levels and acute phase reactants with PDUS synovitis were assessed using correlation and linear regression analyses. The accuracy and discriminatory capacity in detecting PDUS synovitis was assessed using ROC curves. PDUS synovitis was found in 62.4 % of RA patients and 32 % of PsA patients. Both RA and PsA patients with PDUS synovitis had higher calprotectin levels and lower TNFi trough serum levels. Calprotectin positively correlated with ultrasound scores (all r coefficients >0.50 in RA). Calprotectin correlated with the PDUS synovitis score in patients treated with ADA and ETN. Using PDUS synovitis (yes or no) as the reference variable, calprotectin had an AUC of 0.826. The best cut-off was ≥1.66 μg/ml, with a likelihood ratio of 2.77. C-reactive protein (AUC 0.673) and erythrocyte sedimentation rate (AUC 0.731) had a lower discriminatory capacity. TNFi trough serum levels were significantly associated with PDUS synovitis (OR 0.67, 95 % CI 0.52-0.85, p < 0.001) but their accuracy (AUC <0.5) was less than that of calprotectin. TNFi trough serum levels were inversely correlated with calprotectin and PDUS synovitis in RA and PsA patients receiving ADA and ETN. Calprotectin and TNFi trough serum levels may help identify PDUS synovitis in RA and PsA patients in clinical remission or with low disease activity.

Orthopaedic interventions in patients with psoriatic arthritis: a descriptive report from the SPAR cohort.

PubMed

Haque, Naba; Lories, Rik J; de Vlam, Kurt

2016-01-01

To evaluate the current needs for joint surgery in patients with psoriatic arthritis (PsA). The patient database at the Rheumatology Department of the University Hospitals Leuven, was cross-sectionally analysed using demographic, medical, laboratory, radiological and surgical data of 269 patients with PsA. Patients were grouped by the presence or absence of orthopaedic surgery and compared for gender, age, mean health assessment questionnaire (HAQ) score, current medication and disease duration. The data were assessed using descriptive statistics and Student's t-tests. Overall 48.33% of the patients underwent 1 or more orthopaedic surgeries at some point of time. A total of 280 surgical interventions were flagged in the database, including both joint sacrificing and non-joint sacrificing procedures. Mean disease duration±SD at the time of surgery was 1.58 years±12.05. Age of the patients with surgeries was 54.13 years±11.03 SD and not different from those without surgeries (53.73 years±12.81 SD; p=0.78). 41.54% of the patients underwent a single surgery while 58.46% had multiple surgeries. A significant difference in the mean HAQ score was observed among the patients with and without surgeries (p<0.001). Of all the surgeries 63.92% were performed after diagnosis whereas 36.07% were performed before a diagnosis of PsA was made. Among the surgeries performed before diagnosis 40.59% were arthroscopies including 9.90% of diagnostic arthroscopies. The number of surgical interventions has significantly increased in patients with PsA compared with historical cohorts even with a relatively shorter disease duration. There was a significant difference in HAQ score between the patients with or without surgeries.

Decoding semantic information from human electrocorticographic (ECoG) signals.

PubMed

Wang, Wei; Degenhart, Alan D; Sudre, Gustavo P; Pomerleau, Dean A; Tyler-Kabara, Elizabeth C

2011-01-01

This study examined the feasibility of decoding semantic information from human cortical activity. Four human subjects undergoing presurgical brain mapping and seizure foci localization participated in this study. Electrocorticographic (ECoG) signals were recorded while the subjects performed simple language tasks involving semantic information processing, such as a picture naming task where subjects named pictures of objects belonging to different semantic categories. Robust high-gamma band (60-120 Hz) activation was observed at the left inferior frontal gyrus (LIFG) and the posterior portion of the superior temporal gyrus (pSTG) with a temporal sequence corresponding to speech production and perception. Furthermore, Gaussian Naïve Bayes and Support Vector Machine classifiers, two commonly used machine learning algorithms for pattern recognition, were able to predict the semantic category of an object using cortical activity captured by ECoG electrodes covering the frontal, temporal and parietal cortices. These findings have implications for both basic neuroscience research and development of semantic-based brain-computer interface systems (BCI) that can help individuals with severe motor or communication disorders to express their intention and thoughts.

From birth to adolescence: Vienna 2005 European Childhood Obesity Group International Workshop.

PubMed

Pietrobelli, A; Flodmark, C E; Lissau, I; Moreno, L A; Widhalm, K

2005-09-01

In the last 15 y there has been a tremendous increase in the number of studies on pediatric obesity looking at epidemiology, health-related risks, etiology, methodology and treatment. During the early 1990s, the European Childhood Obesity Group (ECOG) was born as a group of scientists' expert in the field of pediatric obesity. ECOG this year celebrates the approach to early maturity with an excited and omni-comprehensive program developing through eight different tracks. Comments on different 'key' papers in each of the eight tracks. The eight tracks were (1) Nutrition requirements and food habits, (2) physical activity, (3) prevention and political actions/strategies, (4) diabetes, (5) metabolism, (6) psychology, (7) pathology, and (8) treatment with emphasis on drugs. Looking at the overall picture of the ECOG workshop we could conclude that despite the fact that childhood obesity is a crisis facing worldwide youth, it is necessary that action to control it must be taken now. All the six relevant levels (ie, family, schools, health professionals, government, industry and media) could be involved in prevention of child and adolescent obesity.

Evaluating statistical approaches to leverage large clinical datasets for uncovering therapeutic and adverse medication effects.

PubMed

Choi, Leena; Carroll, Robert J; Beck, Cole; Mosley, Jonathan D; Roden, Dan M; Denny, Joshua C; Van Driest, Sara L

2018-04-18

Phenome-wide association studies (PheWAS) have been used to discover many genotype-phenotype relationships and have the potential to identify therapeutic and adverse drug outcomes using longitudinal data within electronic health records (EHRs). However, the statistical methods for PheWAS applied to longitudinal EHR medication data have not been established. In this study, we developed methods to address two challenges faced with reuse of EHR for this purpose: confounding by indication, and low exposure and event rates. We used Monte Carlo simulation to assess propensity score (PS) methods, focusing on two of the most commonly used methods, PS matching and PS adjustment, to address confounding by indication. We also compared two logistic regression approaches (the default of Wald vs. Firth's penalized maximum likelihood, PML) to address complete separation due to sparse data with low exposure and event rates. PS adjustment resulted in greater power than propensity score matching, while controlling Type I error at 0.05. The PML method provided reasonable p-values, even in cases with complete separation, with well controlled Type I error rates. Using PS adjustment and the PML method, we identify novel latent drug effects in pediatric patients exposed to two common antibiotic drugs, ampicillin and gentamicin. R packages PheWAS and EHR are available at https://github.com/PheWAS/PheWAS and at CRAN (https://www.r-project.org/), respectively. The R script for data processing and the main analysis is available at https://github.com/choileena/EHR. leena.choi@vanderbilt.edu. Supplementary data are available at Bioinformatics online.

Cortical bone trajectory screw fixation versus traditional pedicle screw fixation for 2-level posterior lumbar interbody fusion: comparison of surgical outcomes for 2-level degenerative lumbar spondylolisthesis.

PubMed

Sakaura, Hironobu; Miwa, Toshitada; Yamashita, Tomoya; Kuroda, Yusuke; Ohwada, Tetsuo

2018-01-01

OBJECTIVE The cortical bone trajectory (CBT) screw technique is a new nontraditional pedicle screw (PS) insertion method. However, the biomechanical behavior of multilevel CBT screw/rod fixation remains unclear, and surgical outcomes in patients after 2-level posterior lumbar interbody fusion (PLIF) using CBT screw fixation have not been reported. Thus, the purposes of this study were to examine the clinical and radiological outcomes after 2-level PLIF using CBT screw fixation for 2-level degenerative lumbar spondylolisthesis (DS) and to compare these outcomes with those after 2-level PLIF using traditional PS fixation. METHODS The study included 22 consecutively treated patients who underwent 2-level PLIF with CBT screw fixation for 2-level DS (CBT group, mean follow-up 39 months) and a historical control group of 20 consecutively treated patients who underwent 2-level PLIF using traditional PS fixation for 2-level DS (PS group, mean follow-up 35 months). Clinical symptoms were evaluated using the Japanese Orthopaedic Association (JOA) scoring system. Bony union was assessed by dynamic plain radiographs and CT images. Surgery-related complications, including symptomatic adjacent-segment disease (ASD), were examined. RESULTS The mean operative duration and intraoperative blood loss were 192 minutes and 495 ml in the CBT group and 218 minutes and 612 ml in the PS group, respectively (p < 0.05 and p > 0.05, respectively). The mean JOA score improved significantly from 12.3 points before surgery to 21.1 points (mean recovery rate 54.4%) at the latest follow-up in the CBT group and from 12.8 points before surgery to 20.4 points (mean recovery rate 51.8%) at the latest follow-up in the PS group (p > 0.05). Solid bony union was achieved at 90.9% of segments in the CBT group and 95.0% of segments in the PS group (p > 0.05). Symptomatic ASD developed in 2 patients in the CBT group (9.1%) and 4 patients in the PS group (20.0%, p > 0.05). CONCLUSIONS Two-level PLIF with CBT screw fixation for 2-level DS could be less invasive and result in improvement of clinical symptoms equal to those of 2-level PLIF using traditional PS fixation. The incidence of symptomatic ASD and the rate of bony union were lower in the CBT group than in the PS group, although these differences were not significant.

Relationship between temperament and transportation with rectal temperature and secretion of cortisol and epinephrine in bulls

USDA-ARS?s Scientific Manuscript database

This study investigated whether temperament influences rectal temperature and the secretion of cortisol and epinephrine in response to transportation. Brahman bulls were selected based on temperament score (average of exit velocity, EV, and pen score, PS) measured 28 days prior to weaning with the 8...

Temperament influences endotoxin-induced changes in rectal temperature, sickness behavior, and plasma epinephrine concentrations in bulls

USDA-ARS?s Scientific Manuscript database

This study was designed to determine the influence of temperament on endotoxin (lipopolysaccharide; LPS) induced changes in body temperature and the secretion of cortisol and epinephrine. Purebred Brahman bulls were selected based on temperament score (average of exit velocity, EV, and pen score, PS...

Relationships Between Temperament and Transportation With Rectal Temperature and Serum Concentrations of Cortisol and Epinephrine in Bulls

USDA-ARS?s Scientific Manuscript database

This study investigated whether temperament influences rectal temperature and serum concentrations of cortisol and epinephrine in response to transportation. Brahman bulls were selected based on temperament score (average of exit velocity, EV, and pen score, PS) measured 28 days prior to weaning wit...

Two-year survival rates of anti-TNF-α therapy in psoriatic arthritis (PsA) patients with either polyarticular or oligoarticular PsA.

PubMed

Iannone, F; Lopriore, S; Bucci, R; Scioscia, C; Anelli, M G; Notarnicola, A; Lapadula, G

2015-05-01

To evaluate the 2-year drug survival rates of the tumour necrosis factor (TNF)-α blockers adalimumab, etanercept, and infliximab in psoriatic arthritis (PsA) patients with either oligoarticular (oligo-PsA) or polyarticular PsA (poly-PsA). We studied a prospective cohort of 328 PsA patients with peripheral arthritis (213 with poly-PsA and 115 with oligo-PsA), beginning their first ever anti-TNF-α treatment with adalimumab, etanercept, or infliximab. The aim of the study was to evaluate the drug survival rates and possible baseline predictors at 2 years. After 24 months, persistence in therapy with the first anti-TNF-α blocker was not statistically different in the oligo-PsA (70.4%) and poly-PsA (65.7%) subsets. Predictors of drug discontinuation were female sex [hazard ratio (HR) 1.63, 95% confidence interval (CI) 1.00-2.68, p = 0.04] and starting the therapy in years 2003-8 (HR 0.51, 95% CI 0.33-0.80, p = 0.003). In poly-PsA, the persistence of etanercept (68.3%) was significantly higher than that of adalimumab (51.9%, p = 0.01), whereas in oligo-PsA no significant difference was detected. In poly-PsA, the period 2003-8 was a negative predictor (HR 0.36, 95% CI 0.21-0.62, p = 0.0001) whereas in oligo-PsA female gender was a positive predictor of drug discontinuation (HR 2.08, 95% CI 1.02-4.24, p = 0.04). With regard to clinical outcomes, the best responses in terms of European League Against Rheumatism (EULAR) 'good' response or Disease Activity Score (DAS28) remission, crude or adjusted according to the LUND Efficacy indeX (LUNDEX), were seen in patients on etanercept or infliximab. Our study provides some evidence that anti-TNF-α drugs may perform differently in PsA, and that the analysis of clinical disease subsets may improve our knowledge and promote better management of PsA.

Quality of life in responders after palliative radiation therapy for painful bone metastases using EORTC QLQ-C30 and EORTC QLQ-BM22: results of a Brazilian cohort.

PubMed

Mendez, Lucas C; Raman, Srinivas; Wan, Bo Angela; da Silva, José Luiz Padilha; Moraes, Fábio Y; Lima, Kennya M L B; Silva, Maurício F; Diz, Maria Del Pilar Estevez; Chow, Edward; Marta, Gustavo Nader

2017-08-01

Bone metastases cause pain, suffering and impaired quality of life (QoL). Palliative radiotherapy (RT) and/or chemotherapy are effective methods in controlling pain, reducing analgesics use and improving QoL. This study goal was to investigate the changes in QoL scores among patients who responded to palliative treatment. A prospective study evaluating the role of radiation therapy in a public academic hospital in São Paulo-Brazil recorded patients' opioid use, pain score, Portuguese version of QLQ-BM22 and QLQ-C30 before and 2 months after radiotherapy. Analgesic use and pain score were used to calculate international pain response category. Overall response was defined as the sum of complete response (CR) and partial response (PR). CR was defined as pain score of 0 with no increase in analgesic intake whereas PR was defined as pain reduction ≥2 without analgesic increase or analgesic reduction in ≥25% without increase in pain at the treated site. From September 2014 to October 2015, 25 patients with bone metastases responded to RT or chemotherapy (1 CR, 24 PR). There were 8 male and 17 female patients. The median age of the 25 patients was 59 (range, 22 to 80) years old. Patient's primary cancer site was breast [11], prostate [5], lung [2], others [7]. For QLQ-BM 22, the mean scores of 4 categories at baseline were: pain site (PS) 39, pain characteristics (PC) 61, function interference (FI) 49 and psycho-social aspects (PA) 57. At 2 month follow up, the scores were PS 27, PC 37, FI 70 and PA 59. Statistical significant improvement (P<0.05) was seen in PS, PC, FI but not PA. In the QLQ-C30, the scores were not statistically different for all categories, except for pain that demonstrated a 33 point decrease in the median pain score domain (66 to 33). Responders to RT at 2 months presented improvement in BM22 and C30 pain domains, and also improvement in functional interference domain of the BM22 questionnaire.

Skilled Memory and Expertise: Mechanisms of Exceptional Performance

DTIC Science & Technology

1988-03-31

information relevant to events integral to the baseball game . If the scored recall is restricted to relevant information, then similar superiority of experts...moves on a CRT and instructed to play out the game mentally. After about 40 plies into a game , Ericsson and Oliver evaluated PS’s memory for the V _9...another experiment, rather than mentally playing through 30 to 40 moves to reach a middle- game chess position, PS memorized two middle- game chess

Bias reduction in repeated-measures observational studies by the use of propensity score: the case of enteral sedation for critically ill patients.

PubMed

Umbrello, Michele; Mistraletti, Giovanni; Corbella, Davide; Cigada, Marco; Salini, Silvia; Morabito, Alberto; Iapichino, Gaetano

2012-12-01

Within the evidence-based medicine paradigm, randomized controlled trials represent the "gold standard" to produce reliable evidence. Indeed, planning and implementing randomized controlled trials in critical care medicine presents limitations because of intrinsic and structural problems. As a consequence, observational studies still occur frequently. In these cases, propensity score (PS) (probability of receiving a treatment conditional on observed covariates) is an increasingly used technique to adjust the results. Few studies addressed the specific issue of a PS correction of repeated-measures designs. Three techniques for correcting the analysis of nonrandomized designs (matching, stratification, regression adjustment) are presented in a tutorial form and applied to a real case study: the comparison between intravenous and enteral sedative therapy in the intensive care unit setting. After showing the results before and after the use of PS, we suggest that such a tool allows to partially overcoming the bias associated with the observational nature of the study. It permits to correct the estimates for any observed covariate, while unobserved confounders cannot be controlled for. Propensity score represents a useful additional tool to estimate the effects of treatments in nonrandomized studies. In the case study, an enteral sedation approach was equally effective to an intravenous regime, allowing for a lower level of sedation and spare of resources. Copyright © 2012 Elsevier Inc. All rights reserved.

Treatment-related mortality in patients with advanced-stage hodgkin lymphoma: an analysis of the german hodgkin study group.

PubMed

Wongso, Diana; Fuchs, Michael; Plütschow, Annette; Klimm, Beate; Sasse, Stephanie; Hertenstein, Bernd; Maschmeyer, Georg; Vieler, Tom; Dührsen, Ulrich; Lindemann, Walter; Aulitzky, Walter; Diehl, Volker; Borchmann, Peter; Engert, Andreas

2013-08-01

The introduction of BEACOPP(escalated) (escalated-dose bleomycin, etoposide, doxorubicin, cyclophosphamide, vincristine, procarbazine, and prednisone) has significantly improved tumor control and overall survival in patients with advanced-stage Hodgkin lymphoma. However, this regimen has also been associated with higher treatment-related mortality (TRM). Thus, we analyzed clinical course and risk factors associated with TRM during treatment with BEACOPP(escalated). In this retrospective analysis, we investigated incidence, clinical features, and risk factors for BEACOPP(escalated)-associated TRM in the German Hodgkin Study Group trials HD9, HD12, and HD15. Among a total of 3,402 patients, TRM of 1.9% (64 of 3,402) was mainly related to neutropenic infections (n = 56; 87.5%). Twenty of 64 events occurred during the first course of BEACOPP(escalated) (31.3%). Higher risk of TRM was seen in patients age ≥ 40 years with poor performance status (PS) and in patients age ≥ 50 years. PS and age were then used to construct a new risk score; those with a score ≥ 2 had TRM of 7.1%, whereas patients who scored 0 or 1 had TRM of 0.9%. The individual risk of TRM associated with BEACOPP(escalated) can be predicted by a simple algorithm based on age and PS. High-risk patients should receive special clinical attention.

Radioembolization for Neuroendocrine Liver Metastases: Safety, Imaging, and Long-Term Outcomes

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

Memon, Khairuddin; Lewandowski, Robert J.; Mulcahy, Mary F.

2012-07-01

Purpose: To present long-term outcomes on the safety and efficacy of Yttrium-90 radioembolization in the treatment of unresectable hepatic neuroendocrine metastases refractory to standard-of-care therapy. Methods and Materials: This study was approved by our institutional review board and was compliant with the Health Insurance Portability and Accountability Act. Forty patients with hepatic neuroendocrine metastases were treated with {sup 90}Y radioembolization at a single center. Toxicity was assessed using National Cancer Institute Common Terminology Criteria v3.0. Response to therapy was assessed by World Health Organization (WHO) guidelines for size and European Association for the Study of the Liver disease (EASL) guidelinesmore » for necrosis. Time to response and overall survival were calculated using the Kaplan-Meier method. Univariate and multivariate analyses were performed. Results: The median dose was 113 Gy (29-299 Gy). Clinical toxicities included fatigue (63%), nausea/vomiting (40%), abdominal pain (18%), fever (8%), diarrhea and weight loss (5%); Grade 3 and 4 bilirubin toxicities were experienced by 2 patients and 1 patient, respectively. Different responses were noted by WHO (complete response, 1.2%; partial response, 62.7%) and EASL (complete response, 20.5%; partial response, 43.4%). Median time to response was 4 and 4.9 months by lesion and patient, respectively. The 1-, 2-, and 3-year overall survival rates were 72.5%, 62.5%, and 45%, respectively. Eastern Cooperative Oncology Group (ECOG) performance score 0 (p < 0.0001), tumor burden {<=}25% (p = 0.0019), albumin {>=}3.5 g/dL (p = 0.017), and bilirubin {<=}1.2 mg/dL (p = 0.002) prognosticated survival on univariate analysis; only ECOG performance score 0 and bilirubin {<=}1.2 mg/dL prognosticated better survival outcome on multivariate analysis (p = 0.0001 and p = 0.02). Conclusion: Yttrium-90 therapy for hepatic neuroendocrine metastases leads to satisfactory tumor response and patient survival with low toxicity, in line with published national guidelines recommending radioembolization as a potential option for unresectable hepatic neuroendocrine metastases.« less

Spatial resolution dependence on spectral frequency in human speech cortex electrocorticography.

PubMed

Muller, Leah; Hamilton, Liberty S; Edwards, Erik; Bouchard, Kristofer E; Chang, Edward F

2016-10-01

Electrocorticography (ECoG) has become an important tool in human neuroscience and has tremendous potential for emerging applications in neural interface technology. Electrode array design parameters are outstanding issues for both research and clinical applications, and these parameters depend critically on the nature of the neural signals to be recorded. Here, we investigate the functional spatial resolution of neural signals recorded at the human cortical surface. We empirically derive spatial spread functions to quantify the shared neural activity for each frequency band of the electrocorticogram. Five subjects with high-density (4 mm center-to-center spacing) ECoG grid implants participated in speech perception and production tasks while neural activity was recorded from the speech cortex, including superior temporal gyrus, precentral gyrus, and postcentral gyrus. The cortical surface field potential was decomposed into traditional EEG frequency bands. Signal similarity between electrode pairs for each frequency band was quantified using a Pearson correlation coefficient. The correlation of neural activity between electrode pairs was inversely related to the distance between the electrodes; this relationship was used to quantify spatial falloff functions for cortical subdomains. As expected, lower frequencies remained correlated over larger distances than higher frequencies. However, both the envelope and phase of gamma and high gamma frequencies (30-150 Hz) are largely uncorrelated (<90%) at 4 mm, the smallest spacing of the high-density arrays. Thus, ECoG arrays smaller than 4 mm have significant promise for increasing signal resolution at high frequencies, whereas less additional gain is achieved for lower frequencies. Our findings quantitatively demonstrate the dependence of ECoG spatial resolution on the neural frequency of interest. We demonstrate that this relationship is consistent across patients and across cortical areas during activity.

Spatial resolution dependence on spectral frequency in human speech cortex electrocorticography

NASA Astrophysics Data System (ADS)

Muller, Leah; Hamilton, Liberty S.; Edwards, Erik; Bouchard, Kristofer E.; Chang, Edward F.

2016-10-01

Objective. Electrocorticography (ECoG) has become an important tool in human neuroscience and has tremendous potential for emerging applications in neural interface technology. Electrode array design parameters are outstanding issues for both research and clinical applications, and these parameters depend critically on the nature of the neural signals to be recorded. Here, we investigate the functional spatial resolution of neural signals recorded at the human cortical surface. We empirically derive spatial spread functions to quantify the shared neural activity for each frequency band of the electrocorticogram. Approach. Five subjects with high-density (4 mm center-to-center spacing) ECoG grid implants participated in speech perception and production tasks while neural activity was recorded from the speech cortex, including superior temporal gyrus, precentral gyrus, and postcentral gyrus. The cortical surface field potential was decomposed into traditional EEG frequency bands. Signal similarity between electrode pairs for each frequency band was quantified using a Pearson correlation coefficient. Main results. The correlation of neural activity between electrode pairs was inversely related to the distance between the electrodes; this relationship was used to quantify spatial falloff functions for cortical subdomains. As expected, lower frequencies remained correlated over larger distances than higher frequencies. However, both the envelope and phase of gamma and high gamma frequencies (30-150 Hz) are largely uncorrelated (<90%) at 4 mm, the smallest spacing of the high-density arrays. Thus, ECoG arrays smaller than 4 mm have significant promise for increasing signal resolution at high frequencies, whereas less additional gain is achieved for lower frequencies. Significance. Our findings quantitatively demonstrate the dependence of ECoG spatial resolution on the neural frequency of interest. We demonstrate that this relationship is consistent across patients and across cortical areas during activity.

Serum antioxidant levels and nutritional status in early and advanced stage lung cancer patients.

PubMed

Klarod, Kultida; Hongsprabhas, Pranithi; Khampitak, Tueanjit; Wirasorn, Kosin; Kiertiburanakul, Sasisopin; Tangrassameeprasert, Roongpet; Daduang, Jureerut; Yongvanit, Puangrat; Boonsiri, Patcharee

2011-01-01

Malnutrition frequently occurs in lung cancer patients. We aimed to determine nutritional status and antioxidant and mineral levels in Thai patients with lung cancer. A prospective study with matched case-control was conducted. Nutritional status was assessed by body mass index (BMI) and subjective global assessment (SGA). Eastern Cooperative Oncology Group (ECOG) performance status was used to assess the performance. The serum antioxidant and mineral levels were determined. Forty-nine patients with a mean age of 58.8 (range, 35-82) who were first diagnosed with lung cancer were enrolled. They were compared with 60 healthy controls, and levels of retinol, α-tocopherol, β-carotene, lycopene, β-cryptoxanthin, selenium, and zinc were lower (P < 0.05). However, peroxidase activity was higher (P = 0.002) in patients. Selenium levels were higher in early stage compared to advanced stage patients (P = 0.041). Overweight patients had higher selenium levels (0.04 mg/L) than normal BMI patients (β = 0.04, P = 0.035). Patients with SGA class C had lower selenium levels (0.03 mg/L) than those with class A (β = -0.03, P = 0.035). The poorer ECOG performance patients had significantly lower β-carotene (β = -0.192, P = 0.003) and selenium (β = -0.031, P = 0.011) levels compared with those with good ECOG performance status. Significantly lower levels of antioxidants and selenium were found in lung cancer patients compared to healthy controls. Levels of some antioxidants and minerals differed among categories of BMI, SGA categories, or ECOG performance status. These findings may be helpful for further studies, such as the effect of nutritional supplementation on clinical outcomes. Copyright © 2011 Elsevier Inc. All rights reserved.

Adaptive shut-down of EEG activity predicts critical acidemia in the near-term ovine fetus.

PubMed

Frasch, Martin G; Durosier, Lucien Daniel; Gold, Nathan; Cao, Mingju; Matushewski, Brad; Keenliside, Lynn; Louzoun, Yoram; Ross, Michael G; Richardson, Bryan S

2015-07-01

In fetal sheep, the electrocorticogram (ECOG) recorded directly from the cortex during repetitive heart rate (FHR) decelerations induced by umbilical cord occlusions (UCO) predictably correlates with worsening hypoxic-acidemia. In human fetal monitoring during labor, the equivalent electroencephalogram (EEG) can be recorded noninvasively from the scalp. We tested the hypothesis that combined fetal EEG - FHR monitoring allows for early detection of worsening hypoxic-acidemia similar to that shown for ECOG-FHR monitoring. Near-term fetal sheep (n = 9) were chronically instrumented with arterial and venous catheters, ECG, ECOG, and EEG electrodes and umbilical cord occluder, followed by 4 days of recovery. Repetitive UCOs of 1 min duration and increasing strength (with regard to the degree of reduction in umbilical blood flow) were induced each 2.5 min until pH dropped to <7.00. Repetitive UCOs led to marked acidosis (arterial pH 7.35 ± 0.01 to 7.00 ± 0.03). At pH of 7.22 ± 0.03 (range 7.32-7.07), and 45 ± 9 min (range 1 h 33 min-20 min) prior to attaining pH < 7.00, both ECOG and EEG amplitudes began to decrease ~fourfold during each FHR deceleration in a synchronized manner. Confirming our hypothesis, these findings support fetal EEG as a useful adjunct to FHR monitoring during human labor for early detection of incipient fetal acidemia. © 2015 The Authors. Physiological Reports published by Wiley Periodicals, Inc. on behalf of the American Physiological Society and The Physiological Society.

Optimizing the Detection of Wakeful and Sleep-Like States for Future Electrocorticographic Brain Computer Interface Applications.

PubMed

Pahwa, Mrinal; Kusner, Matthew; Hacker, Carl D; Bundy, David T; Weinberger, Kilian Q; Leuthardt, Eric C

2015-01-01

Previous studies suggest stable and robust control of a brain-computer interface (BCI) can be achieved using electrocorticography (ECoG). Translation of this technology from the laboratory to the real world requires additional methods that allow users operate their ECoG-based BCI autonomously. In such an environment, users must be able to perform all tasks currently performed by the experimenter, including manually switching the BCI system on/off. Although a simple task, it can be challenging for target users (e.g., individuals with tetraplegia) due to severe motor disability. In this study, we present an automated and practical strategy to switch a BCI system on or off based on the cognitive state of the user. Using a logistic regression, we built probabilistic models that utilized sub-dural ECoG signals from humans to estimate in pseudo real-time whether a person is awake or in a sleep-like state, and subsequently, whether to turn a BCI system on or off. Furthermore, we constrained these models to identify the optimal anatomical and spectral parameters for delineating states. Other methods exist to differentiate wake and sleep states using ECoG, but none account for practical requirements of BCI application, such as minimizing the size of an ECoG implant and predicting states in real time. Our results demonstrate that, across 4 individuals, wakeful and sleep-like states can be classified with over 80% accuracy (up to 92%) in pseudo real-time using high gamma (70-110 Hz) band limited power from only 5 electrodes (platinum discs with a diameter of 2.3 mm) located above the precentral and posterior superior temporal gyrus.

Uterine disease and its effect on subsequent reproductive performance of dairy cattle: a comparison of two cow-side diagnostic methods.

PubMed

Šavc, Miha; Duane, Mary; O'Grady, Luke E; Somers, Joris R; Beltman, Marijke E

2016-11-01

The aim of this study was to compare vaginal mucus scoring and ultrasonographic assessment of uterine content as predictors of future reproductive performance of dairy cows. Holstein-Friesian cows (n = 493) from seven commercial dairy farms were enrolled in this study. All cows received one prebreeding examination (PBE) between 21 and 38 days after parturition. During the PBE, vaginal mucus was scored (MS) and the transrectal ultrasonographic examination of the uterus to assess content (UTS) took place. The MS was scored on a scale of 0 to 3 using a Metricheck device and appearance of the uterus on transrectal ultrasound was scored on a scale of 0 to 4 based on the presence and consistency of intraluminal fluid. Other data collected from each cow included the farm ID (F_ID), conception rate to first service, length of breeding window, lactation number, calving month, body condition score (BCS) at calving, BCS loss after calving, BCS at PBE, days in milk at PBE, 305 day milk yield, economic breeding index (EBI), EBI fertility subindex and EBI health subindex. For each cow these parameters were analyzed using univariate Cox proportional hazard model to evaluate the effect of variables on the reproductive performance, measured as positive pregnancy status (PS) at the end of the breeding season. Receiver-operating characteristic analysis of the diagnostic tests compared with each other took place as well. Cows with positive UTS were 7.75 times more likely to have a positive MS as well (P < 0.01). The PS hazard ratios for cows with UTS0, 1, 2, 3, and 4 were 1; 0.84; 0.53; 0.78; 0.28, respectively (P < 0.001). For the cows with MS0, 1, 2, and 3, the PR hazard ratios were 1; 1.02; 0.51; 0.75; respectively (P = 0.01). Conception rate to first service, breeding window, and PS were significantly better for the cows with UTS0, 1 and 2 compared with the cows with UTS3-4 and MS2+3 (68%; 18%, [P = 0.020]; 29; 75 days, [P = 0.001]; 95%; 55%; [P = 0.010], respectively). There was a significant effect of days in milk at PBE in relation to the subsequent PS (P = 0.04). Cows in lactation number 5 or more were less likely (r = 0.69) to get in calf before the end of the breeding season than cows in their first lactation. Cows that calved later in the season were less likely to become pregnant before the end of the breeding season (P < 0.03). Younger cows (lactation <5) and cows with MS and UTS scores of 0 and -1 had significantly better reproductive performance (P < 0.04). Receiver-operating characteristic analysis showed that MS did not always reflect UTS, but cows with positive UTS were 7.75 times more likely to have a positive MS (P < 0.01) and a high UTS had a larger negative effect on time to PS than a high MS (P < 0.05). In conclusion, both prebreeding vaginal mucus evaluation with the Metricheck device and an ultrasound scan of the uterus serve as a good predictor of the subsequent PS. There is overlap between the two systems, but the best predictor for future reproductive outcome of the cow is a combination of both. Copyright © 2016 Elsevier Inc. All rights reserved.

Comparison of screening questionnaires to identify psoriatic arthritis in a primary-care population: a cross-sectional study.

PubMed

Coates, L C; Savage, L; Waxman, R; Moverley, A R; Worthington, S; Helliwell, P S

2016-09-01

Many questionnaires are available for assessment of psoriatic arthritis (PsA), but there is little evidence comparing them. To test the proposed CONTEST questionnaire, which was developed to identify patients with psoriasis who have undiagnosed PsA, and compare it with the validated Psoriasis Epidemiology Screening Tool (PEST) questionnaire in a primary-care setting. A random sample of adult patients with psoriasis and no diagnosis of arthritis was identified from five general practice surgeries in Yorkshire, U.K. Consenting patients completed both questionnaires and were assessed by a dermatologist and rheumatologist. Diagnosis of PsA was made by the assessing rheumatologist. Receiver operator characteristic (ROC) curve analysis examined the sensitivity and specificity of potential cut points. In total 932 packs were sent to recruit 191 (20·5%) participants. Of these, 169 (88·5%) were confirmed to have current or previous psoriasis. Using physician diagnosis 17 (10·1%) were found to have previously undiagnosed PsA, while 90 (53·3%) had another musculoskeletal complaint and 62 (36·7%) had no musculoskeletal problems. Using ROC curve analysis, all of the questionnaires showed a significant ability to identify PsA. The area under the curve (AUC) for the CONTEST questionnaires was slightly higher than that of PEST (0·69 and 0·70 vs. 0·65), but there was no significant difference identified. Examining the sensitivities and specificities for the different cut points suggested that a PEST score ≥ 2 would perform better in this dataset, and the optimal scores for CONTEST and CONTEST plus joint manikin were 3 and 4, respectively. The accuracy of the questionnaires to identify PsA appeared similar, with a slightly higher AUC for the CONTEST questionnaires. The optimal cut points in this study appeared lower than in previous studies. © 2016 British Association of Dermatologists.

Early Disease Activity or Clinical Response as Predictors of Long‐Term Outcomes With Certolizumab Pegol in Axial Spondyloarthritis or Psoriatic Arthritis

PubMed Central

Deodhar, A.; Fleischmann, R.; Mease, P. J.; Rudwaleit, M.; Nurminen, T.; Davies, O.

2017-01-01

Objective Early identification of patients unlikely to achieve good long‐term disease control with anti–tumor necrosis factor therapy in axial spondyloarthritis (SpA) and psoriatic arthritis (PsA) is important for physicians following treat‐to‐target recommendations. Here we assess associations between disease activity or clinical response during the first 12 weeks of treatment and attainment of treatment targets at week 48 in axial SpA and PsA patients receiving certolizumab pegol. Methods The relationship between disease activity or clinical response during the first 12 weeks of treatment and achievement of week‐48 targets (for axial SpA: inactive disease based on Ankylosing Spondylitis Disease Activity Score [ASDAS] using the C‐reactive protein [CRP] level, or Bath Ankylosing Spondylitis Disease Activity Index <2 with normal CRP level; and for PsA: minimal disease activity) was assessed post hoc using RAPID‐axSpA and RAPID‐PsA trial data. Results A clear relationship between disease activity from week 2 to 12 and achievement of week‐48 treatment targets was observed in both axial SpA and PsA populations. In axial SpA, week‐48 ASDAS inactive disease was achieved by 0% of patients (0 of 21) with ASDAS very high disease activity at week 12, compared to 68% of patients (34 of 50) with week‐12 ASDAS inactive disease. For PsA, week‐48 minimal disease activity was achieved by 0% of patients (0 of 26) with Disease Activity Score in 28 joints (DAS28) using the CRP level >5.1 at week 12, compared to 73% of patients (57 of 78) with DAS28‐CRP <2.6. Similar results were observed regardless of the disease activity measure used. Clinical response at week 12 also predicted week‐48 outcomes, though to a lesser extent than disease activity. Conclusion Using disease activity and the clinical response state during the first 12 weeks of certolizumab pegol treatment, it was possible to identify a subset of axial SpA and PsA patients unlikely to achieve long‐term treatment goals. PMID:27696727

Metronomic chemotherapy in platinum-insensitive failures and/or early failures postmultimodality management in oral cancers

PubMed Central

Patil, Vijay M.; Noronha, Vanita; Joshi, Amit; Pinninti, Rakesh; Dhumal, Sachin; Bhattacharjee, Atanu; Prabhash, Kumar

2015-01-01

Purpose: Oral cancer patients with platinum-resistant disease and or early failures have limited treatment options. This analysis was planned to study the efficacy of metronomic chemotherapy in this group of patients. Materials and Methods: This was a retrospective analysis of oral cancer patients who had squamous cell carcinoma and had an early failure and/or platinum-insensitive failure. Early failure was defined as a failure either within 1-month of adjuvant radiotherapy or within 6 months of chemoradiation (CTRT). A sample size of 100 patients was selected for this study. If ≥39 of 100 patients would have survived at 6 months with metronomic chemotherapy, then additional studies would be warranted. Results: The ECOG PS was 0-1 in 92 patients and 2 in 8 patients. The subsite of primary was buccal mucosa in 38 patients (38%), anterior two-third tongue (oral tongue) in 51 patients (51%), and alveolus in 11 patients (11%). The median estimated overall survival was 110 days (95% confidence interval [CI]: 85-134 days). The proportion of patients surviving at 6 months was 26.4% (95% CI: 17.9-35.6). Conclusion: Metronomic combination of methotrexate and celecoxib failed to meet its prespecified efficacy limit and should not be used in these patients as routine. PMID:26855524

The Risk of Achilles or Biceps Tendon Rupture in New Statin Users: A Propensity Score-Matched Sequential Cohort Study.

PubMed

Spoendlin, Julia; Layton, J Bradley; Mundkur, Mallika; Meier, Christian; Jick, Susan S; Meier, Christoph R

2016-12-01

Case reports and pharmacovigilance data reported cases of tendon ruptures in statin users, but evidence from observational studies is scarce and inconclusive. We aimed to assess the association between new statin use and tendon rupture. We performed a propensity score (PS)-matched sequential cohort study, using data from the Clinical Practice Research Datalink. Patients aged ≥45 years with at least one new statin prescription between 1995 and 2014 were PS-matched within 2-year entry blocks to patients without a statin prescription during the block. We followed patients until they had a recorded Achilles or biceps tendon rupture, completed 5 years of follow-up, or were censored for change in exposure status or another censoring criterion. We calculated hazard ratios (HRs) with 95 % confidence intervals (CIs), applying Cox proportional hazard analyses in the overall cohort (crude and multivariable) and in the PS-matched cohort. We performed subgroup analyses by sex, age, treatment duration, and statin dose. We observed a crude HR of 1.32 (95 % CI 1.21-1.44) in the overall cohort, which attenuated after multivariable adjustment (HR 1.02, 95 % CI 0.92-1.12) and after PS-matching (HR 0.95, 95 % CI 0.84-1.08). Crude HRs were higher in women than in men, but remained around null in both sexes after multivariable adjustment and PS-matching. Subgroup analyses by age, treatment duration, and statin dose revealed null results across all subgroups. The results of this cohort study suggest that statin use does not increase the risk of tendon rupture, irrespective of gender, age, statin dose, or treatment duration.

Do observational studies using propensity score methods agree with randomized trials? A systematic comparison of studies on acute coronary syndromes

PubMed Central

Dahabreh, Issa J.; Sheldrick, Radley C.; Paulus, Jessica K.; Chung, Mei; Varvarigou, Vasileia; Jafri, Haseeb; Rassen, Jeremy A.; Trikalinos, Thomas A.; Kitsios, Georgios D.

2012-01-01

Aims Randomized controlled trials (RCTs) are the gold standard for assessing the efficacy of therapeutic interventions because randomization protects from biases inherent in observational studies. Propensity score (PS) methods, proposed as a potential solution to confounding of the treatment–outcome association, are widely used in observational studies of therapeutic interventions for acute coronary syndromes (ACS). We aimed to systematically assess agreement between observational studies using PS methods and RCTs on therapeutic interventions for ACS. Methods and results We searched for observational studies of interventions for ACS that used PS methods to estimate treatment effects on short- or long-term mortality. Using a standardized algorithm, we matched observational studies to RCTs based on patients’ characteristics, interventions, and outcomes (‘topics’), and we compared estimates of treatment effect between the two designs. When multiple observational studies or RCTs were identified for the same topic, we performed a meta-analysis and used the summary relative risk for comparisons. We matched 21 observational studies investigating 17 distinct clinical topics to 63 RCTs (median = 3 RCTs per observational study) for short-term (7 topics) and long-term (10 topics) mortality. Estimates from PS analyses differed statistically significantly from randomized evidence in two instances; however, observational studies reported more extreme beneficial treatment effects compared with RCTs in 13 of 17 instances (P = 0.049). Sensitivity analyses limited to large RCTs, and using alternative meta-analysis models yielded similar results. Conclusion For the treatment of ACS, observational studies using PS methods produce treatment effect estimates that are of more extreme magnitude compared with those from RCTs, although the differences are rarely statistically significant. PMID:22711757

Impact on Patient Safety and Satisfaction of Implementation of an Outpatient Clinic in Interventional Radiology (IPSIPOLI-Study): A Quasi-Experimental Prospective Study

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

Lutjeboer, Jacob, E-mail: j.lutjeboer@lumc.nl; Burgmans, Mark Christiaan, E-mail: m.c.burgmans@lumc.nl, E-mail: mburgmans@hotmail.com; Chung, Kaman, E-mail: kaman.chung10@gmail.com

PurposeInterventional radiology (IR) procedures are associated with high rates of preparation and planning errors. In many centers, pre-procedural consultation and screening of patients is performed by referring physicians. Interventional radiologists have better knowledge about procedure details and risks, but often only get acquainted with the patient in the procedure room. We hypothesized that patient safety (PS) and patient satisfaction (PSAT) in elective IR procedures would improve by implementation of a pre-procedural visit to an outpatient IR clinic.Material and MethodsIRB approval was obtained and informed consent was waived. PS and PSAT were measured in patients undergoing elective IR procedures before (controlmore » group; n = 110) and after (experimental group; n = 110) implementation of an outpatient IR clinic. PS was measured as the number of process deviations. PSAT was assessed using a questionnaire measuring Likert scores of three dimensions: interpersonal care aspects, information/communication, and patient participation. Differences in PS and PSAT between the two groups were compared using an independent t test.ResultsThe average number of process deviations per patient was 0.39 in the control group compared to 0.06 in the experimental group (p < 0.001). In 9.1 % patients in the control group, no legal informed consent was obtained compared to 0 % in the experimental group. The mean overall Likert score was significantly higher in the experimental group compared to the control group: 2.68 (SD 0.314) versus 2.48 (SD 0.381) (p < 0.001).ConclusionPS and PSAT improve significantly if patients receive consultation and screening in an IR outpatient clinic prior to elective IR procedures.« less

Mesenchymal stem cells and their conditioned medium improve integration of purified induced pluripotent stem cell-derived cardiomyocyte clusters into myocardial tissue.

PubMed

Rubach, Martin; Adelmann, Roland; Haustein, Moritz; Drey, Florian; Pfannkuche, Kurt; Xiao, Bing; Koester, Annette; Udink ten Cate, Floris E A; Choi, Yeong-Hoon; Neef, Klaus; Fatima, Azra; Hannes, Tobias; Pillekamp, Frank; Hescheler, Juergen; Šarić, Tomo; Brockmeier, Konrad; Khalil, Markus

2014-03-15

Induced pluripotent stem cell-derived cardiomyocytes (iPS-CMs) might become therapeutically relevant to regenerate myocardial damage. Purified iPS-CMs exhibit poor functional integration into myocardial tissue. The aim of this study was to investigate whether murine mesenchymal stem cells (MSCs) or their conditioned medium (MScond) improves the integration of murine iPS-CMs into myocardial tissue. Vital or nonvital embryonic murine ventricular tissue slices were cocultured with purified clusters of iPS-CMs in combination with murine embryonic fibroblasts (MEFs), MSCs, or MScond. Morphological integration was assessed by visual scoring and functional integration by isometric force and field potential measurements. We observed a moderate morphological integration of iPS-CM clusters into vital, but a poor integration into nonvital, slices. MEFs and MSCs but not MScond improved morphological integration of CMs into nonvital slices and enabled purified iPS-CMs to confer force. Coculture of vital slices with iPS-CMs and MEFs or MSCs resulted in an improved electrical integration. A comparable improvement of electrical coupling was achieved with the cell-free MScond, indicating that soluble factors secreted by MSCs were involved in electrical coupling. We conclude that cells such as MSCs support the engraftment and adhesion of CMs, and confer force to noncontractile tissue. Furthermore, soluble factors secreted by MSCs mediate electrical coupling of purified iPS-CM clusters to myocardial tissue. These data suggest that MSCs may increase the functional engraftment and therapeutic efficacy of transplanted iPS-CMs into infarcted myocardium.

Mesenchymal Stem Cells and Their Conditioned Medium Improve Integration of Purified Induced Pluripotent Stem Cell–Derived Cardiomyocyte Clusters into Myocardial Tissue

PubMed Central

Rubach, Martin; Adelmann, Roland; Haustein, Moritz; Drey, Florian; Pfannkuche, Kurt; Xiao, Bing; Koester, Annette; Udink ten Cate, Floris E.A.; Choi, Yeong-Hoon; Neef, Klaus; Fatima, Azra; Hannes, Tobias; Pillekamp, Frank; Hescheler, Juergen; Šarić, Tomo; Brockmeier, Konrad

2014-01-01

Induced pluripotent stem cell–derived cardiomyocytes (iPS-CMs) might become therapeutically relevant to regenerate myocardial damage. Purified iPS-CMs exhibit poor functional integration into myocardial tissue. The aim of this study was to investigate whether murine mesenchymal stem cells (MSCs) or their conditioned medium (MScond) improves the integration of murine iPS-CMs into myocardial tissue. Vital or nonvital embryonic murine ventricular tissue slices were cocultured with purified clusters of iPS-CMs in combination with murine embryonic fibroblasts (MEFs), MSCs, or MScond. Morphological integration was assessed by visual scoring and functional integration by isometric force and field potential measurements. We observed a moderate morphological integration of iPS-CM clusters into vital, but a poor integration into nonvital, slices. MEFs and MSCs but not MScond improved morphological integration of CMs into nonvital slices and enabled purified iPS-CMs to confer force. Coculture of vital slices with iPS-CMs and MEFs or MSCs resulted in an improved electrical integration. A comparable improvement of electrical coupling was achieved with the cell-free MScond, indicating that soluble factors secreted by MSCs were involved in electrical coupling. We conclude that cells such as MSCs support the engraftment and adhesion of CMs, and confer force to noncontractile tissue. Furthermore, soluble factors secreted by MSCs mediate electrical coupling of purified iPS-CM clusters to myocardial tissue. These data suggest that MSCs may increase the functional engraftment and therapeutic efficacy of transplanted iPS-CMs into infarcted myocardium. PMID:24219308

Effectiveness of early adalimumab therapy in psoriatic arthritis patients from Reuma.pt - EARLY PsA.

PubMed

Santos, Helena; Eusébio, Mónica; Borges, Joana; Gonçalves, Diana; Ávila-Ribeiro, Pedro; Faria, Daniela Santos; Lopes, Carina; Rovisco, João; Águeda, Ana; Nero, Patrícia; Valente, Paula; Cravo, Ana Rita; Santos, Maria José

2017-01-01

Objective To compare outcomes in psoriatic arthritis (PsA) patients initiating adalimumab (ADA), with short- and long-term disease duration and to evaluate the potential effect of concomitant conventional synthetic disease-modifying antirheumatic drugs (csDMARD) or glucocorticoids. Methods Analyses included adult PsA patients registered in the Rheumatic Diseases Portuguese Register (Reuma.pt) between June 2008-June 2016 who received ADA for ≥3 months. Psoriatic Arthritis Response Criteria (PsARC) response, tender and swollen joint count, inflammatory parameters, patient (PtGA) and physician global assessment (PhGA), Disease Activity Score-28 joints (DAS28), and Health Assessment Questionnaire Disability Index (HAQ-DI) were compared between patients with <5 years of disease (early PsA) and those with ≥5 years of disease duration (late PsA). Time to achieving PsARC response was estimated using the Kaplan-Meier method. Results Of 135 PsA patients treated with ADA, 126 had information on disease duration (earlyPsA, n=41). PsARC response was achieved by 72.9% of the patients (88.0% early PsA vs 62.2% late PsA; P=0.022) after 3 months and by 85.4% after 24 months (100% early PsA vs 75.9% late PsA; P=0.044). Early PsA patients achieved significantly less painful joints (2.7 vs 6.7, p=0.006), lower mean C-reactive protein (0.5 mg/dL vs 1.3 mg/dL; P=0.011), and PhGA (18.3 vs 28.1; P=0.020) at 3 months. In the long term, early PsA patients also had fewer swollen joints (0.3 vs 1.7; P=0.030) and lower PhGA (6.3 vs 21.9; P<0.001), C-reactive protein (0.4 mg/dL vs 1.0 mg/dL; P=0.026), and DAS28 (2.2 vs 3.2; P=0.030). HAQ-DI decreased in both groups reaching a mean value at 24 months of 0.4 and 0.8 (P=ns) in early and late PsA, respectively. Early PsA patients obtained PsARC response more rapidly than late PsA (3.8 and 7.4 months, respectively; P=0.008). Concomitant csDMARDs showed clinical benefit (2-year PsARC response, 88.3% vs 60.0%; P=0.044). Concomitant glucocorticoids had no effect on PsARC response over 2 years of follow-up. Persistence on ADA was similar in both groups. Conclusion Early PsA patients had a greater chance of improvement after ADA therapy and better functional outcome, and achieved PsARC response more rapidly than late PsA. In this cohort, comedication with csDMARDs was beneficial over 2 years.

Quality-of-life and performance status results from the phase III RAINBOW study of ramucirumab plus paclitaxel versus placebo plus paclitaxel in patients with previously treated gastric or gastroesophageal junction adenocarcinoma.

PubMed

Al-Batran, S-E; Van Cutsem, E; Oh, S C; Bodoky, G; Shimada, Y; Hironaka, S; Sugimoto, N; Lipatov, O N; Kim, T-Y; Cunningham, D; Rougier, P; Muro, K; Liepa, A M; Chandrawansa, K; Emig, M; Ohtsu, A; Wilke, H

2016-04-01

The phase III RAINBOW trial demonstrated that the addition of ramucirumab to paclitaxel improved overall survival, progression-free survival, and tumor response rate in fluoropyrimidine-platinum previously treated patients with advanced gastric/gastroesophageal junction (GEJ) adenocarcinoma. Here, we present results from quality-of-life (QoL) and performance status (PS) analyses. Patients with Eastern Cooperative Oncology Group PS of 0/1 were randomized to receive ramucirumab (8 mg/kg i.v.) or placebo on days 1 and 15 of a 4-week cycle, with both arms receiving paclitaxel (80 mg/m(2)) on days 1, 8, and 15. Patient-reported outcomes were assessed with the QoL/health status questionnaires EORTC QLQ-C30 and EQ-5D at baseline and 6-week intervals. PS was assessed at baseline and day 1 of every cycle. Time to deterioration (TtD) in each QLQ-C30 scale was defined as randomization to first worsening of ≥10 points (on 100-point scale) and TtD in PS was defined as first worsening to ≥2. Hazard ratios (HRs) for treatment effect were estimated using stratified Cox proportional hazards models. Of the 665 patients randomized, 650 (98%) provided baseline QLQ-C30 and EQ-5D data, and 560 (84%) also provided data from ≥1 postbaseline time point. Baseline scores for both instruments were similar between arms. Of the 15 QLQ-C30 scales, 14 had HR < 1, indicating similar or longer TtD in QoL for ramucirumab + paclitaxel. Treatment with ramucirumab + paclitaxel was also associated with a delay in TtD in PS to ≥2 (HR = 0.798, P = 0.0941). Alternate definitions of PS deterioration yielded similar results: PS ≥ 3 (HR = 0.656, P = 0.0508), deterioration by ≥1 PS level (HR = 0.802, P = 0.0444), and deterioration by ≥2 PS levels (HR = 0.608, P = 0.0063). EQ-5D scores were comparable between treatment arms, stable during treatment, and worsened at discontinuation. In patients with previously treated advanced gastric/GEJ adenocarcinoma, addition of ramucirumab to paclitaxel prolonged overall survival while maintaining patient QoL with delayed symptom worsening and functional status deterioration. NCT01170663. © The Author 2016. Published by Oxford University Press on behalf of the European Society for Medical Oncology.

Spikes, Local Field Potentials, and Electrocorticogram Characterization during Motor Learning in Rats for Brain Machine Interface Tasks.

PubMed

Marzullo, T C; Dudley, J R; Miller, C R; Trejo, L; Kipke, D R

2005-01-01

Brain machine interface development typically falls into two arenas, invasive extracellular recording and non-invasive electroencephalogram recording methods. The relationship between action potentials and field potentials is not well understood, and investigation of interrelationships may improve design of neuroprosthetic control systems. Rats were trained on a motor learning task whereby they had to insert their noses into an aperture while simultaneously pressing down on levers with their forepaws; spikes, local field potentials (LFPs), and electrocorticograms (ECoGs) over the motor cortex were recorded and characterized. Preliminary results suggest that the LFP activity in lower cortical layers oscillates with the ECoG.

Cerebral ganglioglioma with epilepsy: neuroimaging features and treatment.

PubMed

Nishio, S; Morioka, T; Mihara, F; Gondo, K; Fukui, M

2001-03-01

Gangliogliomas are an increasingly recognized cause of epilepsy in children. In this study the clinical, neuroimaging, and neurophysiological data of five patients with cerebral ganglioglioma and epilepsy are reviewed retrospectively. The average age of these patients was 4.4 years at onset and the average duration of seizures before diagnosis was 11 months. Tumors were located in the frontal (3), parietal (1), and occipital (1) lobes. While one cystic and four solid tumors showed various densities on CT and MRI, one frontal lesion was not demonstrated by CT scan but clearly shown by MRI. Scalp electroencephalography (EEG) showed neither localized nor epileptiform abnormalities in three patients, while the remaining two had these abnormalities. In one patient, invasive chronic electrocorticography (ECoG) recordings with subdural electrodes revealed an ictal onset zone located in the hand motor area. In all patients, intraoperative ECoG failed to reveal any epileptiform activities, and tumor removal alone was performed. For a mean of 3.4 years after surgery, all patients are alive and seizure-free, with stable imaging findings. Tumor resection may be the most important factor for optimal seizure control and prevention of tumor recurrence despite the fact that EEG and ECoG findings may conflict on tumor location.

Two magneto-encephalographic epileptic foci did not coincide with the electrocorticographic ictal onset zone in a patient with temporal lobe epilepsy.

PubMed

Hisada, K; Morioka, T; Nishio, S; Yamamoto, T; Fukui, M

2001-12-01

To evaluate the usefulness and limitations of magneto-encephalography (MEG) for epilepsy surgery, we compared 'interictal' epileptic spike fields on MEG with ictal electrocorticography (ECoG) using invasive chronic subdural electrodes in a patient with intractable medial temporal lobe epilepsy (MTLE) associated with vitamin K deficiency intracerebral hemorrhage. A 19-year-old male with an 8-year history of refractory complex partial seizures, secondarily generalized, and right hemispheric atrophy and porencephaly in the right frontal lobe on MRI, was studied with MEG to define the interictal paroxysmal sources based on the single-dipole model. This was followed by invasive ECoG monitoring to delineate the epileptogenic zone. MEG demonstrated two paroxysmal foci, one each on the right lateral temporal and frontal lobes. Ictal ECoG recordings revealed an ictal onset zone on the right medial temporal lobe, which was different from that defined by MEG. Anterior temporal lobectomy with hippocampectomy was performed and the patient has been seizure free for two years. Our results indicate that interictal MEG does not always define the epileptogenic zone in patients with MTLE.

Analysis of Direct Recordings from the Surface of the Human Brain

NASA Astrophysics Data System (ADS)

Towle, Vernon L.

2006-03-01

Recording electrophysiologic signals directly from the cortex of patients with chronically implanted subdural electrodes provides an opportunity to map the functional organization of human cortex. In addition to using direct cortical stimulation, sensory evoked potentials, and electrocorticography (ECoG) can also be used. The analysis of ECoG power spectrums and inter-electrode lateral coherence patterns may be helpful in identifying important eloquent cortical areas and epileptogenic regions in cortical multifocal epilepsy. Analysis of interictal ECoG coherence can reveal pathological cortical areas that are functionally distinct from patent cortex. Subdural ECoGs have been analyzed from 50 medically refractive pediatric epileptic patients as part of their routine surgical work-up. Recording arrays were implanted over the frontal, parietal, occipital or temporal lobes for 4-10 days, depending on the patient's seizure semiology and imaging studies. Segments of interictal ECoG ranging in duration from 5 sec to 45 min were examined to identify areas of increased local coherence. Ictal records were examined to identify the stages and spread of the seizures. Immediately before a seizure began, lateral coherence values decreased, reorganized, and then increased during the late ictal and post-ictal periods. When computed over relatively long interictal periods (45 min) coherence patterns were found to be highly stable (r = 0.97, p < .001), and only changed gradually over days. On the other hand, when calculated over short periods of time (5 sec) coherence patterns were highly dynamic. Coherence patterns revealed a rich topography, with reduced coherence across sulci and major fissures. Areas that participate in receptive and expressive speech can be mapped through event-related potentials and analysis of task-specific changes in power spectrums. Information processing is associated with local increases in high frequency activity, with concomitant changes in coherence, suggestive of a transiently active language network. Our findings suggest that analysis of coherence patterns can supplement visual inspection of conventional records to help identify pathological regions of cortex. With further study, it is hoped that analysis of single channel dynamics, along with analysis of multichannel lateral coherence patterns, and the functional holographic technique may allow determination of the boundaries of epileptic foci based on brief interictal recordings, possibly obviating the current need for extended monitoring of seizures.

Role of subdural electrocorticography in prediction of long-term seizure outcome in epilepsy surgery

PubMed Central

Juhász, Csaba; Shah, Aashit; Sood, Sandeep; Chugani, Harry T.

2009-01-01

Since prediction of long-term seizure outcome using preoperative diagnostic modalities remains suboptimal in epilepsy surgery, we evaluated whether interictal spike frequency measures obtained from extraoperative subdural electrocorticography (ECoG) recording could predict long-term seizure outcome. This study included 61 young patients (age 0.4–23.0 years), who underwent extraoperative ECoG recording prior to cortical resection for alleviation of uncontrolled focal seizures. Patient age, frequency of preoperative seizures, neuroimaging findings, ictal and interictal ECoG measures were preoperatively obtained. The seizure outcome was prospectively measured [follow-up period: 2.5–6.4 years (mean 4.6 years)]. Univariate and multivariate logistic regression analyses determined how well preoperative demographic and diagnostic measures predicted long-term seizure outcome. Following the initial cortical resection, Engel Class I, II, III and IV outcomes were noted in 35, 6, 12 and 7 patients, respectively. One child died due to disseminated intravascular coagulation associated with pseudomonas sepsis 2 days after surgery. Univariate regression analyses revealed that incomplete removal of seizure onset zone, higher interictal spike-frequency in the preserved cortex and incomplete removal of cortical abnormalities on neuroimaging were associated with a greater risk of failing to obtain Class I outcome. Multivariate logistic regression analysis revealed that incomplete removal of seizure onset zone was the only independent predictor of failure to obtain Class I outcome. The goodness of regression model fit and the predictive ability of regression model were greatest in the full regression model incorporating both ictal and interictal measures [R2 0.44; Area under the receiver operating characteristic (ROC) curve: 0.81], slightly smaller in the reduced model incorporating ictal but not interictal measures (R2 0.40; Area under the ROC curve: 0.79) and slightly smaller again in the reduced model incorporating interictal but not ictal measures (R2 0.27; Area under the ROC curve: 0.77). Seizure onset zone and interictal spike frequency measures on subdural ECoG recording may both be useful in predicting the long-term seizure outcome of epilepsy surgery. Yet, the additive clinical impact of interictal spike frequency measures to predict long-term surgical outcome may be modest in the presence of ictal ECoG and neuroimaging data. PMID:19286694

A randomized, controlled study to evaluate the role of an in-home asthma disease management program provided by respiratory therapists in improving outcomes and reducing the cost of care.

PubMed

Shelledy, David C; Legrand, Terry S; Gardner, Donna D; Peters, Jay I

2009-03-01

Asthma management programs (AMP) may reduce costs and improve outcomes in patients with moderate to severe asthma. However, it is not known which personnel are best able to deliver such interventions and what settings are most effective. The purpose of this study was to compare the effects of an in-home AMP provided by respiratory therapists (RTs) to an AMP provided by nurses (RNs) and to usual care (UC) provided in physician offices or clinics. Subjects (age 18-64) who had been admitted to the emergency department (ED) or hospital for acute asthma exacerbation were randomized to three groups: AMP-RT, AMP-RN or UC. The AMP groups received five (5) weekly home visits to provide assessment and instruction; the UC group was instructed to return to their physician for routine follow-up. Outcomes assessed at 6 months included hospitalizations, in patient days, hospitalization cost, ED visits and cost, clinic visits, pulmonary function, symptoms, health related quality of life (HRQOL), asthma episode self-management score (AESM), environmental assessment, and patient satisfaction (PS). Variables were compared using ANOVA with a Neuman-Keuls follow-up for multiple comparisons using an intent-to-treat approach. Upon enrollment, (n = 159) there were no differences (p > .05) between groups for age, gender, pulmonary function or HRQOL (SF-36 and St. Georges Respiratory Questionnaire - SGRQ). At 6 months, both AMP groups (AMP-RN n = 54; AMP-RT n = 46) had significantly fewer (p < 0.05) hospitalizations and in-patient days, lower hospitalization costs, and greater HRQOL physical component summary change scores (PCS) and PS than UC (n = 59). AMP-RT also had greater PEFR, SGRQ Total and SGRQ Symptoms change scores when compared to UC and significantly better AESM and PS scores as compared to AMP-RN and UC. An in-home asthma management program can be effectively delivered by respiratory therapists and may reduce hospitalizations, in-patient days, cost and improve measures of HRQOL and PS in a population prone to asthma exacerbation.

A Retrospective Study of the Impact of 21-Gene Recurrence Score Assay on Treatment Choice in Node Positive Micrometastatic Breast Cancer

PubMed Central

Frazier, Thomas G.; Fox, Kevin R.; Smith, J. Stanley; Laronga, Christine; McSwain, Anita; Paul, Devchand; Schultz, Michael; Stilwill, Joseph; Teal, Christine; Weisberg, Tracey; Vacchino, Judith F.; Sing, Amy P.; Cherepanov, Dasha; Hsiao, Wendy; Chang, Eunice; Broder, Michael S.

2015-01-01

To assess clinical utility of the 21-gene assay (Oncotype DX® Recurrence Score®), we determined whether women with HER2(−)/ER+ pN1mi breast cancer with low (<18) Recurrence Scores results are given adjuvant chemotherapy in a lower proportion than those with high scores (≥31). This was a multicenter chart review of ≥18 year old women with pN1mi breast cancer, HER2(−)/ER+ tumors, ductal/lobular/mixed histology, with the assay ordered on or after 1 January 2007. One hundred and eighty one patients had a mean age of 60.7 years; 82.9% had ECOG performance status 0; 33.7% had hypertension, 22.7% had osteoporosis, 18.8% had osteoarthritis, and 8.8% had type-2 diabetes. Mean Recurrence Score was 17.8 (range: 0–50). 48.6% had a mastectomy; 55.8% had a lumpectomy. 19.8% of low-risk group patients were recommended chemotherapy vs. 57.9% in the intermediate-risk group and 100% in the high-risk group (p < 0.001). A total of 80.2% of the low-risk group were recommended endocrine therapy alone, while 77.8% of the high-risk group were recommended both endocrine and chemotherapy (p < 0.001). The Oncotype DX Recurrence Score result provides actionable information that can be incorporated into treatment planning for women with HER2(−)/ER+ pN1mi breast cancer. The Recurrence Score result has clinical utility in treatment planning for HER2(−)/ER+ pN1mi breast cancer patients. PMID:25789420

Ecological Validity and Clinical Utility of Patient-Reported Outcomes Measurement Information System (PROMIS®) instruments for detecting premenstrual symptoms of depression, anger, and fatigue

PubMed Central

Junghaenel, Doerte U.; Schneider, Stefan; Stone, Arthur A.; Christodoulou, Christopher; Broderick, Joan E.

2014-01-01

Objective This study examined the ecological validity and clinical utility of NIH Patient Reported-Outcomes Measurement Information System (PROMIS®) instruments for anger, depression, and fatigue in women with premenstrual symptoms. Methods One-hundred women completed daily diaries and weekly PROMIS assessments over 4 weeks. Weekly assessments were administered through Computerized Adaptive Testing (CAT). Weekly CATs and corresponding daily scores were compared to evaluate ecological validity. To test clinical utility, we examined if CATs could detect changes in symptom levels, if these changes mirrored those obtained from daily scores, and if CATs could identify clinically meaningful premenstrual symptom change. Results PROMIS CAT scores were higher in the pre-menstrual than the baseline (ps < .0001) and post-menstrual (ps < .0001) weeks. The correlations between CATs and aggregated daily scores ranged from .73 to .88 supporting ecological validity. Mean CAT scores showed systematic changes in accordance with the menstrual cycle and the magnitudes of the changes were similar to those obtained from the daily scores. Finally, Receiver Operating Characteristic (ROC) analyses demonstrated the ability of the CATs to discriminate between women with and without clinically meaningful premenstrual symptom change. Conclusions PROMIS CAT instruments for anger, depression, and fatigue demonstrated validity and utility in premenstrual symptom assessment. The results provide encouraging initial evidence of the utility of PROMIS instruments for the measurement of affective premenstrual symptoms. PMID:24630180

Low testosterone levels and increased inflammatory markers in patients with cancer and relationship with cachexia.

PubMed

Burney, Basil O; Hayes, Teresa G; Smiechowska, Joanna; Cardwell, Gina; Papusha, Victor; Bhargava, Peeyush; Konda, Bhavana; Auchus, Richard J; Garcia, Jose M

2012-05-01

Male cancer patients suffer from fatigue, sexual dysfunction, and decreased functional performance and muscle mass. These symptoms are seen in men with hypogonadism and/or inflammatory conditions. However, the relative contribution of testosterone and inflammation to symptom burden in cancer has not been well-established. The aim of this study was to measure testosterone levels in male cancer patients and determine the relationship between testosterone, inflammation, and symptom burden. This cross-sectional study enrolled patients from a tertiary-care center. SUBJECTS/OUTCOME MEASURES: Subjects included males with cancer-cachexia (CC; n = 45) and cancer without cachexia (CNC; n = 50), as well as noncancer controls (CO; n = 45). Total testosterone (TT), bioavailable testosterone, C-reactive protein (CRP), and IL-6 were measured in plasma. Functional performance was assessed by the ECOG (Eastern Cooperative Oncology Group) and KPS (Karnofsky Performance Scales), and sexual function was assessed by the IIEF (International Index of Erectile Function). Low testosterone levels were seen in more than 70% of CC cases. TT was lower in CC compared to CNC (P < 0.05). Also, CC had lower bioavailable testosterone, grip strength, IIEF scores, appendicular lean body mass, and fat mass and higher IL-6 and CRP compared to controls (P ≤ 0.05). ECOG and KPS were lower in CC and CNC compared to controls (P ≤ 0.05). On multiple regression analysis, TT, albumin, and CRP predicted symptoms differentially in cancer patients. CC patients have higher inflammation and lower testosterone, grip strength, functional status, erectile function, fat mass, and appendicular lean body mass. Inflammation, TT, and albumin are associated with heavier symptom burden in this population. Interventional trials are needed to determine whether testosterone replacement and/or antiinflammatory agents benefit cancer patients.

Impact of a comprehensive geriatric assessment to manage elderly patients with locally advanced non-small-cell lung cancers: An open phase II study using concurrent cisplatin-oral vinorelbine and radiotherapy (GFPC 08-06).

PubMed

Locher, Chrystèle; Pourel, Nicolas; Le Caer, Hervé; Berard, Henri; Auliac, Jean-Bernard; Monnet, Isabelle; Descourt, Renaud; Vergnenègre, Alain; Lafay, Isabelle Martel; Greillier, Laurent; Chouaïd, Christos

2018-07-01

Few data have been published on the optimal management of elderly patients with locally advanced non-small-cell lung cancers (La-NSCLC). This prospective, multicenter, phase II study was undertaken to evaluate the ability of a comprehensive geriatric assessment (CGA) to select the elderly La-NSCLC patients who potentially may benefit from concurrent radio-chemotherapy. The main inclusion criteria were: La-NSCLC, >70 years old, at least one measurable target, ECOG performance status (PS) 0/1 and normal CGA. Weekly cisplatin (30 mg/m 2 ) and oral vinorelbine (30 mg/m 2 ) were combined with standard thoracic radiotherapy (66 Gy, 33 fractions) for 6.5 weeks. The primary evaluation criterion was <15% clinically relevant grade >2 toxicity. Secondary criteria were response rates, overall survival (OS) and progression-free survival (PFS). Among the 49 patients screened, 40 were included: 87.5% men, median age: 75.1 (70-84) years, 67.5% with PS 0, 52.5% squamous cell carcinomas. The full concurrent regimen was administrated in 77.5% of the cases (chemotherapy: 85%, radiotherapy: 90%); 22.5% of the patients experienced toxicity grade >2 (with three treatment-imputed deaths), 15% when restricted to clinically relevant >2 grade toxicities. One (2.6%) patient achieved a complete response, 53.8% had partial responses and 35.9% stable disease. Median PFS was 15 (95%CI: 8,7-35,2) months, OS 21.8 (95%CI: 16-NR) months and 1-, 2- and 4-year survival rates were 77.5%, 45% and 34.8%. CGA was able to select fit elderly patients with La-NSCLCs eligible for concurrent chemoradiotherapy with a satisfactory risk/benefit ratio. Copyright © 2018 Elsevier B.V. All rights reserved.

DockRank: Ranking docked conformations using partner-specific sequence homology-based protein interface prediction

PubMed Central

Xue, Li C.; Jordan, Rafael A.; EL-Manzalawy, Yasser; Dobbs, Drena; Honavar, Vasant

2015-01-01

Selecting near-native conformations from the immense number of conformations generated by docking programs remains a major challenge in molecular docking. We introduce DockRank, a novel approach to scoring docked conformations based on the degree to which the interface residues of the docked conformation match a set of predicted interface residues. Dock-Rank uses interface residues predicted by partner-specific sequence homology-based protein–protein interface predictor (PS-HomPPI), which predicts the interface residues of a query protein with a specific interaction partner. We compared the performance of DockRank with several state-of-the-art docking scoring functions using Success Rate (the percentage of cases that have at least one near-native conformation among the top m conformations) and Hit Rate (the percentage of near-native conformations that are included among the top m conformations). In cases where it is possible to obtain partner-specific (PS) interface predictions from PS-HomPPI, DockRank consistently outperforms both (i) ZRank and IRAD, two state-of-the-art energy-based scoring functions (improving Success Rate by up to 4-fold); and (ii) Variants of DockRank that use predicted interface residues obtained from several protein interface predictors that do not take into account the binding partner in making interface predictions (improving success rate by up to 39-fold). The latter result underscores the importance of using partner-specific interface residues in scoring docked conformations. We show that DockRank, when used to re-rank the conformations returned by ClusPro, improves upon the original ClusPro rankings in terms of both Success Rate and Hit Rate. DockRank is available as a server at http://einstein.cs.iastate.edu/DockRank/. PMID:23873600

DockRank: ranking docked conformations using partner-specific sequence homology-based protein interface prediction.

PubMed

Xue, Li C; Jordan, Rafael A; El-Manzalawy, Yasser; Dobbs, Drena; Honavar, Vasant

2014-02-01

Selecting near-native conformations from the immense number of conformations generated by docking programs remains a major challenge in molecular docking. We introduce DockRank, a novel approach to scoring docked conformations based on the degree to which the interface residues of the docked conformation match a set of predicted interface residues. DockRank uses interface residues predicted by partner-specific sequence homology-based protein-protein interface predictor (PS-HomPPI), which predicts the interface residues of a query protein with a specific interaction partner. We compared the performance of DockRank with several state-of-the-art docking scoring functions using Success Rate (the percentage of cases that have at least one near-native conformation among the top m conformations) and Hit Rate (the percentage of near-native conformations that are included among the top m conformations). In cases where it is possible to obtain partner-specific (PS) interface predictions from PS-HomPPI, DockRank consistently outperforms both (i) ZRank and IRAD, two state-of-the-art energy-based scoring functions (improving Success Rate by up to 4-fold); and (ii) Variants of DockRank that use predicted interface residues obtained from several protein interface predictors that do not take into account the binding partner in making interface predictions (improving success rate by up to 39-fold). The latter result underscores the importance of using partner-specific interface residues in scoring docked conformations. We show that DockRank, when used to re-rank the conformations returned by ClusPro, improves upon the original ClusPro rankings in terms of both Success Rate and Hit Rate. DockRank is available as a server at http://einstein.cs.iastate.edu/DockRank/. Copyright © 2013 Wiley Periodicals, Inc.

The skin in psoriasis: assessment and challenges.

PubMed

Oji, Vinzenz; Luger, Thomas A

2015-01-01

The coexistence of psoriasis arthritis (PsA) and psoriasis vulgaris in about 20% of patients with psoriasis leads to a need for rheumatologic-dermatologic team work. We summarise the role of dermatologists in assessment of the skin in psoriasis. Chronic plaque psoriasis must be differentiated from other subtypes such as generalised pustular psoriasis (GPP) or palmoplantar pustulosis (PPP). Therapeutic management is based on the evaluation of the disease severity. Quantitative scoring of skin severity includes calculation of the Psoriasis Area and Severity Index (PASI), body surface area (BSA) as well as the Dermatology Life Quality Index (DLQI). These scoring systems do not replace the traditional dermatologic medical history and physical examination of the patient. The skin should be examined for additional skin diseases; moreover, patients should be monitored for comorbidity, most importantly PsA and cardiovascular comorbidity.

A comparison of skeletal maturity and growth.

PubMed

Molinari, Luciano; Gasser, Theo; Largo, Remo

2013-07-01

Somatic and bone development have each been studied in detail, but rarely in conjunction. The aim of this study was to determine what somatic and bone development have in common and how they differ. A second aim was to check for a pubertal spurt in bone age (BA) and to quantify it in a similar way as has been done for height. The Preece-Baines model is used to fit longitudinal data for BA. The data analysed are from the 1st Zurich Longitudinal Growth Study comprising 120 boys and 112 girls with almost complete data from birth to adulthood. Variability of somatic milestones was reduced in terms of BA and there was an aftergrowth after reaching adult RUS score 1000. A strong increase in the RUS score was seen at a late stage of the pubertal spurt (PS). Somatic milestones correlated with the RUS score attained at these ages and more so at an early stage of the PS. A PS for BA was clearly identified with a location at 14.2 years for boys and 12.2 years for girls. Age of peak bone development correlated highly with age of peak velocity of somatic variables. BA can be successfully modelled as a semi-quantitative entity. Bone development shows marked associations with somatic development, despite the fact that the latter reflects changes in size, while the former is essentially a maturity index and reflects changes in biochemical composition of tissues.

Autonomic nervous system reactivity within the valence-arousal affective space: Modulation by sex and age.

PubMed

Gomez, Patrick; von Gunten, Armin; Danuser, Brigitta

2016-11-01

In the present study, we examined how sex and age shape cardiovascular, electrodermal, and pupillary reactivity to picture series within the valence-arousal affective space in a sample of 176 healthy younger, middle-aged, and older men and women. Across participants, heart rate (HR) decelerated with increasing self-reported unpleasantness, whereas skin conductance level (SCL) and pupil size (PS) increased with increasing self-rated arousal. Systolic (SBP) and diastolic (DBP) blood pressure increased with increasing self-rated arousal when valence was pleasant but much less when valence was unpleasant. Compared to women, men exhibited a stronger correlation between valence and HR and an SBP response characterized by larger increases for pleasant high-arousal states and lower change scores for unpleasant low- and high-arousal and pleasant low-arousal states. Men's largest SCL change scores were for pleasant high-arousal states, whereas women's largest SCL change scores were for unpleasant high-arousal states. The arousal-PS relationship was stronger among women, in particular for unpleasant series. From younger to older age, there were decreases in the strength of the valence-HR, arousal-SCL, and arousal-PS relationships. Older adults had larger overall increases in SBP and DBP than younger adults, but the relationships with self-reported valence and arousal were not age dependent. We discuss how the observed sex and age effects may reflect sex and age differences in emotional processing and in basic autonomic nervous system functioning. Copyright © 2016 Elsevier B.V. All rights reserved.

Classification of comorbidity in trauma: the reliability of pre-injury ASA physical status classification.

PubMed

Ringdal, Kjetil G; Skaga, Nils Oddvar; Steen, Petter Andreas; Hestnes, Morten; Laake, Petter; Jones, J Mary; Lossius, Hans Morten

2013-01-01

Pre-injury comorbidities can influence the outcomes of severely injured patients. Pre-injury comorbidity status, graded according to the American Society of Anesthesiologists Physical Status (ASA-PS) classification system, is an independent predictor of survival in trauma patients and is recommended as a comorbidity score in the Utstein Trauma Template for Uniform Reporting of Data. Little is known about the reliability of pre-injury ASA-PS scores. The objective of this study was to examine whether the pre-injury ASA-PS system was a reliable scale for grading comorbidity in trauma patients. Nineteen Norwegian trauma registry coders were invited to participate in a reliability study in which 50 real but anonymised patient medical records were distributed. Reliability was analysed using quadratic weighted kappa (κ(w)) analysis with 95% CI as the primary outcome measure and unweighted kappa (κ) analysis, which included unknown values, as a secondary outcome measure. Fifteen of the invitees responded to the invitation, and ten participated. We found moderate (κ(w)=0.77 [95% CI: 0.64-0.87]) to substantial (κ(w)=0.95 [95% CI: 0.89-0.99]) rater-against-reference standard reliability using κ(w) and fair (κ=0.46 [95% CI: 0.29-0.64]) to substantial (κ=0.83 [95% CI: 0.68-0.94]) reliability using κ. The inter-rater reliability ranged from moderate (κ(w)=0.66 [95% CI: 0.45-0.81]) to substantial (κ(w)=0.96 [95% CI: 0.88-1.00]) for κ(w) and from slight (κ=0.36 [95% CI: 0.21-0.54]) to moderate (κ=0.75 [95% CI: 0.62-0.89]) for κ. The rater-against-reference standard reliability varied from moderate to substantial for the primary outcome measure and from fair to substantial for the secondary outcome measure. The study findings indicate that the pre-injury ASA-PS scale is a reliable score for classifying comorbidity in trauma patients. Copyright © 2012 Elsevier Ltd. All rights reserved.

Nocturnal sleep, daytime sleepiness, and quality of life in stable patients on hemodialysis

PubMed Central

Parker, Kathy P; Kutner, Nancy G; Bliwise, Donald L; Bailey, James L; Rye, David B

2003-01-01

Background Although considerable progress has been made in the treatment of chronic kidney disease, compromised quality of life continues to be a significant problem for patients receiving hemodialysis (HD). However, in spite of the high prevalence of sleep complaints and disorders in this population, the relationship between these problems and quality of life remains to be well characterized. Thus, we studied a sample of stable HD patients to explore relationships between quality of life and both subjective and objective measures of nocturnal sleep and daytime sleepiness Methods The sample included forty-six HD patients, 24 men and 22 women, with a mean age of 51.6 (10.8) years. Subjects underwent one night of polysomnography followed the next morning by a Multiple Sleep Latency Test (MSLT), an objective measure of daytime sleepiness. Subjects also completed: 1) a brief nocturnal sleep questionnaire; 2) the Epworth Sleepiness Scale; and, 3) the Quality of Life Index (QLI, Dialysis Version) which provides an overall QLI score and four subscale scores for Health & Functioning (H&F), Social & Economic (S&E), Psychological & Spiritual (P&S), and Family (F). (The range of scores is 0 to 30 with higher scores indicating better quality of life.) Results The mean (standard deviation; SD) of the overall QLI was 22.8 (4.0). The mean (SD) of the four subscales were as follows: H&F – 21.1 (4.7); S&E – 22.0 (4.8); P&S – 24.5 (4.4); and, F – 26.8 (3.5). H&F (rs = -0.326, p = 0.013) and F (rs = -0.248, p = 0.048) subscale scores were negatively correlated with periodic limb movement index but not other polysomnographic measures. The H&F subscale score were positively correlated with nocturnal sleep latency (rs = 0.248, p = 0.048) while the H&F (rs = 0.278, p = 0.030) and total QLI (rs = 0.263, p = 0.038) scores were positively associated with MSLT scores. Both of these latter findings indicate that higher life quality is associated with lower sleepiness levels. ESS scores were unrelated to overall QLI scores or the subscale scores. Subjective reports of difficulty falling asleep and waking up too early were significantly correlated with all four subscale scores and overall QLI. Feeling rested in the morning was positively associated with S&E, P&S, and Total QLI scores. Conclusion Selected measures of both poor nocturnal sleep and increased daytime sleepiness are associated with decreased quality of life in HD patients, underscoring the importance of recognizing and treating these patients' sleep problems. PMID:14633280

[Two cases of mesial temporal lobe epilepsy associated with old intracerebral hemorrhage in the lateral temporal lobe without "dual pathology"].

PubMed

Morioka, T; Nishio, S; Hisada, K; Muraishi, M; Ishibashi, H; Mamiya, K; Ohfu, M; Fukui, M

1998-05-01

Two cases of intractable temporal lobe epilepsy associated with old intracerebral hemorrhage in the lateral temporal lobe were reported. Although preoperative magnetic resonance imaging (MRI) failed to reveal hippocampal atrophy with T2 hyperintensity, electrocorticographic (ECoG) recording with chronic invasive subdural electrodes indicated the mesial temporal lobe to be an ictal onset zone. After anterior temporal lobectomy involving the lesion and hippocampectomy, the patients became seizure-free. Hippocampal sclerosis, namely "dual pathology", was not noted on histological examination. Careful ECoG recording with chronic subdural electrodes is mandatory even when the preoperative MRI does not demonstrate the radiological hippocampal sclerosis.

Reading skills, creativity, and insight: exploring the connections.

PubMed

Mourgues, Catalina V; Preiss, David D; Grigorenko, Elena L

2014-08-04

Studies of the relationship between creativity and specific reading disabilities have produced inconclusive results. We explored their relationship in a sample of 259 college students (age range: 17 to 38 years-old) from three Chilean universities. The students were tested on their verbal ability, creativity, and insight. A simple linear regression was performed on the complete sample, and on high- and low-achievement groups that were formed based on reading test scores. We observed a significant correlation in the total sample between outcomes on the verbal ability tasks, and on the creativity and insight tasks (range r =. 152 to r =. 356, ps <.001). Scores on the reading comprehension and phonological awareness tasks were the best predictors of performance on creativity and insight tasks (range β = .315 to β = .155, ps <.05). A comparison of the low- and high-scoring groups on verbal ability tasks yielded results to the same effect. These findings do not support the hypothesis that specific reading disability is associated with better performance on creative tasks. Instead, higher verbal ability was found to be associated with higher creativity and insight.

Antipsychotics and mortality: adjusting for mortality risk scores to address confounding by terminal illness.

PubMed

Park, Yoonyoung; Franklin, Jessica M; Schneeweiss, Sebastian; Levin, Raisa; Crystal, Stephen; Gerhard, Tobias; Huybrechts, Krista F

2015-03-01

To determine whether adjustment for prognostic indices specifically developed for nursing home (NH) populations affect the magnitude of previously observed associations between mortality and conventional and atypical antipsychotics. Cohort study. A merged data set of Medicaid, Medicare, Minimum Data Set (MDS), Online Survey Certification and Reporting system, and National Death Index for 2001 to 2005. Dual-eligible individuals aged 65 and older who initiated antipsychotic treatment in a NH (N=75,445). Three mortality risk scores (Mortality Risk Index Score, Revised MDS Mortality Risk Index, Advanced Dementia Prognostic Tool) were derived for each participant using baseline MDS data, and their performance was assessed using c-statistics and goodness-of-fit tests. The effect of adjusting for these indices in addition to propensity scores (PSs) on the association between antipsychotic medication and mortality was evaluated using Cox models with and without adjustment for risk scores. Each risk score showed moderate discrimination for 6-month mortality, with c-statistics ranging from 0.61 to 0.63. There was no evidence of lack of fit. Imbalances in risk scores between conventional and atypical antipsychotic users, suggesting potential confounding, were much lower within PS deciles than the imbalances in the full cohort. Accounting for each score in the Cox model did not change the relative risk estimates: 2.24 with PS-only adjustment versus 2.20, 2.20, and 2.22 after further adjustment for the three risk scores. Although causality cannot be proven based on nonrandomized studies, this study adds to the body of evidence rejecting explanations other than causality for the greater mortality risk associated with conventional antipsychotics than with atypical antipsychotics. © 2015, Copyright the Authors Journal compilation © 2015, The American Geriatrics Society.

Optogenetic micro-electrocorticography for modulating and localizing cerebral cortex activity

PubMed Central

Richner, Thomas J.; Thongpang, Sanitta; Brodnick, Sarah K.; Schendel, Amelia A.; Falk, Ryan W.; Krugner-Higby, Lisa A.; Pashaie, Ramin; Williams, Justin C.

2014-01-01

Objective Spatial localization of neural activity from within the brain with electrocorticography (ECoG) and electroencephalography (EEG) remains a challenge in clinical and research settings, and while microfabricated ECoG (micro-ECoG) array technology continues to improve, complimentary methods to simultaneously modulate cortical activity while recording are needed. Approach We developed a neural interface utilizing optogenetics, cranial windowing, and micro-ECoG arrays fabricated on a transparent polymer. This approach enabled us to directly modulate neural activity at known locations around micro-ECoG arrays in mice expressing Channelrhodopsin-2 (ChR2). We applied photostimuli varying in time, space and frequency to the cortical surface, and we targeted multiple depths within the cortex using an optical fiber while recording micro-ECoG signals. Main Results Negative potentials of up to 1.5 mV were evoked by photostimuli applied to the entire cortical window, while focally applied photostimuli evoked spatially localized micro-ECoG potentials. Two simultaneously applied focal stimuli could be separated, depending on the distance between them. Photostimuli applied within the cortex with an optical fiber evoked more complex micro-ECoG potentials with multiple positive and negative peaks whose relative amplitudes depended on the depth of the fiber. Significance Optogenetic ECoG has potential applications in the study of epilepsy, cortical dynamics, and neuroprostheses. PMID:24445482

Carotid blood flow changes with behavioral states in the late gestation llama fetus in utero.

PubMed

Blanco, C E; Giussani, D A; Riquelme, R A; Hanson, M A; Llanos, A J

1997-12-19

This study tested the hypothesis that in the llama fetus changes in cerebral blood flow are closely associated with changes in cerebral oxidative metabolism such as occur during transitions between electrocortical states. For the first time reported in any species, instantaneous changes in common carotid blood flow, employed as a continuous index of cerebrovascular perfusion, were related to instantaneous changes in electrocortical activity. Three late gestation fetal llamas were surgically prepared under general anesthesia with vascular catheters, a tracheal and amniotic catheter, and with electrodes implanted to monitor the fetal electrocorticogram (ECoG). In addition, Transonic flow probes were placed around a common carotid artery and a femoral artery. At least 4 days after surgery fetal arterial blood, amniotic and tracheal pressures, carotid and femoral blood flows and the fetal ECoG were recorded continuously. Our results suggest a close association between increases in common carotid blood flow and low voltage ECoG in the llama fetus. Close coupling between instantaneous changes in carotid blood flow and electrocortical states together with the lack of an increase in brain blood flow without increased cerebral oxygen extraction during hypoxemia in the llama fetus supports a fall in cerebral oxidative metabolism in this species during hypoxemic episodes.

Neuronal synchrony and the relation between the blood-oxygen-level dependent response and the local field potential

PubMed Central

Nguyen, Mai; Winawer, Jonathan

2017-01-01

The most widespread measures of human brain activity are the blood-oxygen-level dependent (BOLD) signal and surface field potential. Prior studies report a variety of relationships between these signals. To develop an understanding of how to interpret these signals and the relationship between them, we developed a model of (a) neuronal population responses and (b) transformations from neuronal responses into the functional magnetic resonance imaging (fMRI) BOLD signal and electrocorticographic (ECoG) field potential. Rather than seeking a transformation between the two measures directly, this approach interprets each measure with respect to the underlying neuronal population responses. This model accounts for the relationship between BOLD and ECoG data from human visual cortex in V1, V2, and V3, with the model predictions and data matching in three ways: across stimuli, the BOLD amplitude and ECoG broadband power were positively correlated, the BOLD amplitude and alpha power (8–13 Hz) were negatively correlated, and the BOLD amplitude and narrowband gamma power (30–80 Hz) were uncorrelated. The two measures provide complementary information about human brain activity, and we infer that features of the field potential that are uncorrelated with BOLD arise largely from changes in synchrony, rather than level, of neuronal activity. PMID:28742093

Electrophysiological and hemodynamic mismatch responses in rats listening to human speech syllables.

PubMed

Mahmoudzadeh, Mahdi; Dehaene-Lambertz, Ghislaine; Wallois, Fabrice

2017-01-01

Speech is a complex auditory stimulus which is processed according to several time-scales. Whereas consonant discrimination is required to resolve rapid acoustic events, voice perception relies on slower cues. Humans, right from preterm ages, are particularly efficient to encode temporal cues. To compare the capacities of preterms to those observed in other mammals, we tested anesthetized adult rats by using exactly the same paradigm as that used in preterm neonates. We simultaneously recorded neural (using ECoG) and hemodynamic responses (using fNIRS) to series of human speech syllables and investigated the brain response to a change of consonant (ba vs. ga) and to a change of voice (male vs. female). Both methods revealed concordant results, although ECoG measures were more sensitive than fNIRS. Responses to syllables were bilateral, but with marked right-hemispheric lateralization. Responses to voice changes were observed with both methods, while only ECoG was sensitive to consonant changes. These results suggest that rats more effectively processed the speech envelope than fine temporal cues in contrast with human preterm neonates, in whom the opposite effects were observed. Cross-species comparisons constitute a very valuable tool to define the singularities of the human brain and species-specific bias that may help human infants to learn their native language.

A brain computer interface using electrocorticographic signals in humans

NASA Astrophysics Data System (ADS)

Leuthardt, Eric C.; Schalk, Gerwin; Wolpaw, Jonathan R.; Ojemann, Jeffrey G.; Moran, Daniel W.

2004-06-01

Brain-computer interfaces (BCIs) enable users to control devices with electroencephalographic (EEG) activity from the scalp or with single-neuron activity from within the brain. Both methods have disadvantages: EEG has limited resolution and requires extensive training, while single-neuron recording entails significant clinical risks and has limited stability. We demonstrate here for the first time that electrocorticographic (ECoG) activity recorded from the surface of the brain can enable users to control a one-dimensional computer cursor rapidly and accurately. We first identified ECoG signals that were associated with different types of motor and speech imagery. Over brief training periods of 3-24 min, four patients then used these signals to master closed-loop control and to achieve success rates of 74-100% in a one-dimensional binary task. In additional open-loop experiments, we found that ECoG signals at frequencies up to 180 Hz encoded substantial information about the direction of two-dimensional joystick movements. Our results suggest that an ECoG-based BCI could provide for people with severe motor disabilities a non-muscular communication and control option that is more powerful than EEG-based BCIs and is potentially more stable and less traumatic than BCIs that use electrodes penetrating the brain. The authors declare that they have no competing financial interests.

Semantic attributes are encoded in human electrocorticographic signals during visual object recognition.

PubMed

Rupp, Kyle; Roos, Matthew; Milsap, Griffin; Caceres, Carlos; Ratto, Christopher; Chevillet, Mark; Crone, Nathan E; Wolmetz, Michael

2017-03-01

Non-invasive neuroimaging studies have shown that semantic category and attribute information are encoded in neural population activity. Electrocorticography (ECoG) offers several advantages over non-invasive approaches, but the degree to which semantic attribute information is encoded in ECoG responses is not known. We recorded ECoG while patients named objects from 12 semantic categories and then trained high-dimensional encoding models to map semantic attributes to spectral-temporal features of the task-related neural responses. Using these semantic attribute encoding models, untrained objects were decoded with accuracies comparable to whole-brain functional Magnetic Resonance Imaging (fMRI), and we observed that high-gamma activity (70-110Hz) at basal occipitotemporal electrodes was associated with specific semantic dimensions (manmade-animate, canonically large-small, and places-tools). Individual patient results were in close agreement with reports from other imaging modalities on the time course and functional organization of semantic processing along the ventral visual pathway during object recognition. The semantic attribute encoding model approach is critical for decoding objects absent from a training set, as well as for studying complex semantic encodings without artificially restricting stimuli to a small number of semantic categories. Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.

High-frequency gamma activity (80-150 Hz) is increased in human cortex during selective attention

PubMed Central

Ray, Supratim; Niebur, Ernst; Hsiao, Steven S.; Sinai, Alon; Crone, Nathan E.

2008-01-01

Objective: To study the role of gamma oscillations (>30 Hz) in selective attention using subdural electrocorticography (ECoG) in humans. Methods: We recorded ECoG in human subjects implanted with subdural electrodes for epilepsy surgery. Sequences of auditory tones and tactile vibrations of 800 ms duration were presented asynchronously, and subjects were asked to selectively attend to one of the two stimulus modalities in order to detect an amplitude increase at 400 ms in some of the stimuli. Results: Event-related ECoG gamma activity was greater over auditory cortex when subjects attended auditory stimuli and was greater over somatosensory cortex when subjects attended vibrotactile stimuli. Furthermore, gamma activity was also observed over prefrontal cortex when stimuli appeared in either modality, but only when they were attended. Attentional modulation of gamma power began ∼400 ms after stimulus onset, consistent with the temporal demands on attention. The increase in gamma activity was greatest at frequencies between 80 and 150 Hz, in the so-called high gamma frequency range. Conclusions: There appears to be a strong link between activity in the high-gamma range (80-150 Hz) and selective attention. Significance: Selective attention is correlated with increased activity in a frequency range that is significantly higher than what has been reported previously using EEG recordings. PMID:18037343

Seizure outcomes in children with epilepsy after resective brain surgery.

PubMed

Nagarajan, Lakshmi; Lee, Michael; Palumbo, Linda; Lee, Sharon; Shah, Snehal; Walsh, Peter; Cannell, Patricia; Ghosh, Soumya

2015-09-01

To assess the role of resective brain surgery in childhood epilepsy. We retrospectively analysed the seizure outcomes in 55 children with epilepsy who had resective brain surgery between 1997 and 2012, at our centre. The children were 1.5-18 years at the time of surgery; their seizure onset was between 0.2 andto 15 years of age. 48 had refractory epilepsy. One child died of tumour progression. Follow-up duration in the survivors ranged from 2 to -16 years (mean: 9).Presurgical evaluation included clinical profiles, non-invasive V-EEG monitoring, neuroimaging with MRIs in all; SPECT and PET in selected patients. 54 had intraoperative ECoG. An Engel Class 1 outcome was seen in 78% of the cohort, with 67% being off all AEDs at the most recent follow-up. Children with tumours constituted the majority (56%), with 87% of this group showing a Class 1 outcome and 84% being off AEDs. Children with cortical dysplasia had a Class 1 outcome in 56%. Resective brain surgery is an efficacious option in some children with epilepsy. We found ECoG useful to tailor the cortical resection and in our opinion ECoG contributed to the good seizure outcomes. Copyright © 2015 European Paediatric Neurology Society. Published by Elsevier Ltd. All rights reserved.

Ecological validity and clinical utility of Patient-Reported Outcomes Measurement Information System (PROMIS®) instruments for detecting premenstrual symptoms of depression, anger, and fatigue.

PubMed

Junghaenel, Doerte U; Schneider, Stefan; Stone, Arthur A; Christodoulou, Christopher; Broderick, Joan E

2014-04-01

This study examined the ecological validity and clinical utility of NIH Patient Reported-Outcomes Measurement Information System (PROMIS®) instruments for anger, depression, and fatigue in women with premenstrual symptoms. One-hundred women completed daily diaries and weekly PROMIS assessments over 4weeks. Weekly assessments were administered through Computerized Adaptive Testing (CAT). Weekly CATs and corresponding daily scores were compared to evaluate ecological validity. To test clinical utility, we examined if CATs could detect changes in symptom levels, if these changes mirrored those obtained from daily scores, and if CATs could identify clinically meaningful premenstrual symptom change. PROMIS CAT scores were higher in the pre-menstrual than the baseline (ps<.0001) and post-menstrual (ps<.0001) weeks. The correlations between CATs and aggregated daily scores ranged from .73 to .88 supporting ecological validity. Mean CAT scores showed systematic changes in accordance with the menstrual cycle and the magnitudes of the changes were similar to those obtained from the daily scores. Finally, Receiver Operating Characteristic (ROC) analyses demonstrated the ability of the CATs to discriminate between women with and without clinically meaningful premenstrual symptom change. PROMIS CAT instruments for anger, depression, and fatigue demonstrated validity and utility in premenstrual symptom assessment. The results provide encouraging initial evidence of the utility of PROMIS instruments for the measurement of affective premenstrual symptoms. Copyright © 2014 Elsevier Inc. All rights reserved.

The impact of confounder selection in propensity scores when applied to prospective cohort studies in pregnancy.

PubMed

Xu, Ronghui; Hou, Jue; Chambers, Christina D

2018-06-01

Our work was motivated by small cohort studies on the risk of birth defects in infants born to pregnant women exposed to medications. We controlled for confounding using propensity scores (PS). The extremely rare events setting renders the matching or stratification infeasible. In addition, the PS itself may be formed via different approaches to select confounders from a relatively long list of potential confounders. We carried out simulation experiments to compare different combinations of approaches: IPW or regression adjustment, with 1) including all potential confounders without selection, 2) selection based on univariate association between the candidate variable and the outcome, 3) selection based on change in effects (CIE). The simulation showed that IPW without selection leads to extremely large variances in the estimated odds ratio, which help to explain the empirical data analysis results that we had observed. Copyright © 2018 Elsevier Inc. All rights reserved.

A review of the application of propensity score methods yielded increasing use, advantages in specific settings, but not substantially different estimates compared with conventional multivariable methods

PubMed Central

Stürmer, Til; Joshi, Manisha; Glynn, Robert J.; Avorn, Jerry; Rothman, Kenneth J.; Schneeweiss, Sebastian

2006-01-01

Objective Propensity score analyses attempt to control for confounding in non-experimental studies by adjusting for the likelihood that a given patient is exposed. Such analyses have been proposed to address confounding by indication, but there is little empirical evidence that they achieve better control than conventional multivariate outcome modeling. Study design and methods Using PubMed and Science Citation Index, we assessed the use of propensity scores over time and critically evaluated studies published through 2003. Results Use of propensity scores increased from a total of 8 papers before 1998 to 71 in 2003. Most of the 177 published studies abstracted assessed medications (N=60) or surgical interventions (N=51), mainly in cardiology and cardiac surgery (N=90). Whether PS methods or conventional outcome models were used to control for confounding had little effect on results in those studies in which such comparison was possible. Only 9 out of 69 studies (13%) had an effect estimate that differed by more than 20% from that obtained with a conventional outcome model in all PS analyses presented. Conclusions Publication of results based on propensity score methods has increased dramatically, but there is little evidence that these methods yield substantially different estimates compared with conventional multivariable methods. PMID:16632131

Spatial co-adaptation of cortical control columns in a micro-ECoG brain-computer interface

NASA Astrophysics Data System (ADS)

Rouse, A. G.; Williams, J. J.; Wheeler, J. J.; Moran, D. W.

2016-10-01

Objective. Electrocorticography (ECoG) has been used for a range of applications including electrophysiological mapping, epilepsy monitoring, and more recently as a recording modality for brain-computer interfaces (BCIs). Studies that examine ECoG electrodes designed and implanted chronically solely for BCI applications remain limited. The present study explored how two key factors influence chronic, closed-loop ECoG BCI: (i) the effect of inter-electrode distance on BCI performance and (ii) the differences in neural adaptation and performance when fixed versus adaptive BCI decoding weights are used. Approach. The amplitudes of epidural micro-ECoG signals between 75 and 105 Hz with 300 μm diameter electrodes were used for one-dimensional and two-dimensional BCI tasks. The effect of inter-electrode distance on BCI control was tested between 3 and 15 mm. Additionally, the performance and cortical modulation differences between constant, fixed decoding using a small subset of channels versus adaptive decoding weights using the entire array were explored. Main results. Successful BCI control was possible with two electrodes separated by 9 and 15 mm. Performance decreased and the signals became more correlated when the electrodes were only 3 mm apart. BCI performance in a 2D BCI task improved significantly when using adaptive decoding weights (80%-90%) compared to using constant, fixed weights (50%-60%). Additionally, modulation increased for channels previously unavailable for BCI control under the fixed decoding scheme upon switching to the adaptive, all-channel scheme. Significance. Our results clearly show that neural activity under a BCI recording electrode (which we define as a ‘cortical control column’) readily adapts to generate an appropriate control signal. These results show that the practical minimal spatial resolution of these control columns with micro-ECoG BCI is likely on the order of 3 mm. Additionally, they show that the combination and interaction between neural adaptation and machine learning are critical to optimizing ECoG BCI performance.

ECoG high gamma activity reveals distinct cortical representations of lyrics passages, harmonic and timbre-related changes in a rock song.

PubMed

Sturm, Irene; Blankertz, Benjamin; Potes, Cristhian; Schalk, Gerwin; Curio, Gabriel

2014-01-01

Listening to music moves our minds and moods, stirring interest in its neural underpinnings. A multitude of compositional features drives the appeal of natural music. How such original music, where a composer's opus is not manipulated for experimental purposes, engages a listener's brain has not been studied until recently. Here, we report an in-depth analysis of two electrocorticographic (ECoG) data sets obtained over the left hemisphere in ten patients during presentation of either a rock song or a read-out narrative. First, the time courses of five acoustic features (intensity, presence/absence of vocals with lyrics, spectral centroid, harmonic change, and pulse clarity) were extracted from the audio tracks and found to be correlated with each other to varying degrees. In a second step, we uncovered the specific impact of each musical feature on ECoG high-gamma power (70-170 Hz) by calculating partial correlations to remove the influence of the other four features. In the music condition, the onset and offset of vocal lyrics in ongoing instrumental music was consistently identified within the group as the dominant driver for ECoG high-gamma power changes over temporal auditory areas, while concurrently subject-individual activation spots were identified for sound intensity, timbral, and harmonic features. The distinct cortical activations to vocal speech-related content embedded in instrumental music directly demonstrate that song integrated in instrumental music represents a distinct dimension in complex music. In contrast, in the speech condition, the full sound envelope was reflected in the high gamma response rather than the onset or offset of the vocal lyrics. This demonstrates how the contributions of stimulus features that modulate the brain response differ across the two examples of a full-length natural stimulus, which suggests a context-dependent feature selection in the processing of complex auditory stimuli.

Continuous decoding of human grasp kinematics using epidural and subdural signals

NASA Astrophysics Data System (ADS)

Flint, Robert D.; Rosenow, Joshua M.; Tate, Matthew C.; Slutzky, Marc W.

2017-02-01

Objective. Restoring or replacing function in paralyzed individuals will one day be achieved through the use of brain-machine interfaces. Regaining hand function is a major goal for paralyzed patients. Two competing prerequisites for the widespread adoption of any hand neuroprosthesis are accurate control over the fine details of movement, and minimized invasiveness. Here, we explore the interplay between these two goals by comparing our ability to decode hand movements with subdural and epidural field potentials (EFPs). Approach. We measured the accuracy of decoding continuous hand and finger kinematics during naturalistic grasping motions in five human subjects. We recorded subdural surface potentials (electrocorticography; ECoG) as well as with EFPs, with both standard- and high-resolution electrode arrays. Main results. In all five subjects, decoding of continuous kinematics significantly exceeded chance, using either EGoG or EFPs. ECoG decoding accuracy compared favorably with prior investigations of grasp kinematics (mean ± SD grasp aperture variance accounted for was 0.54 ± 0.05 across all subjects, 0.75 ± 0.09 for the best subject). In general, EFP decoding performed comparably to ECoG decoding. The 7-20 Hz and 70-115 Hz spectral bands contained the most information about grasp kinematics, with the 70-115 Hz band containing greater information about more subtle movements. Higher-resolution recording arrays provided clearly superior performance compared to standard-resolution arrays. Significance. To approach the fine motor control achieved by an intact brain-body system, it will be necessary to execute motor intent on a continuous basis with high accuracy. The current results demonstrate that this level of accuracy might be achievable not just with ECoG, but with EFPs as well. Epidural placement of electrodes is less invasive, and therefore may incur less risk of encephalitis or stroke than subdural placement of electrodes. Accurately decoding motor commands at the epidural level may be an important step towards a clinically viable brain-machine interface.

Hand posture classification using electrocorticography signals in the gamma band over human sensorimotor brain areas

NASA Astrophysics Data System (ADS)

Chestek, Cynthia A.; Gilja, Vikash; Blabe, Christine H.; Foster, Brett L.; Shenoy, Krishna V.; Parvizi, Josef; Henderson, Jaimie M.

2013-04-01

Objective. Brain-machine interface systems translate recorded neural signals into command signals for assistive technology. In individuals with upper limb amputation or cervical spinal cord injury, the restoration of a useful hand grasp could significantly improve daily function. We sought to determine if electrocorticographic (ECoG) signals contain sufficient information to select among multiple hand postures for a prosthetic hand, orthotic, or functional electrical stimulation system.Approach. We recorded ECoG signals from subdural macro- and microelectrodes implanted in motor areas of three participants who were undergoing inpatient monitoring for diagnosis and treatment of intractable epilepsy. Participants performed five distinct isometric hand postures, as well as four distinct finger movements. Several control experiments were attempted in order to remove sensory information from the classification results. Online experiments were performed with two participants. Main results. Classification rates were 68%, 84% and 81% for correct identification of 5 isometric hand postures offline. Using 3 potential controls for removing sensory signals, error rates were approximately doubled on average (2.1×). A similar increase in errors (2.6×) was noted when the participant was asked to make simultaneous wrist movements along with the hand postures. In online experiments, fist versus rest was successfully classified on 97% of trials; the classification output drove a prosthetic hand. Online classification performance for a larger number of hand postures remained above chance, but substantially below offline performance. In addition, the long integration windows used would preclude the use of decoded signals for control of a BCI system. Significance. These results suggest that ECoG is a plausible source of command signals for prosthetic grasp selection. Overall, avenues remain for improvement through better electrode designs and placement, better participant training, and characterization of non-stationarities such that ECoG could be a viable signal source for grasp control for amputees or individuals with paralysis.

Real-time detection and discrimination of visual perception using electrocorticographic signals

NASA Astrophysics Data System (ADS)

Kapeller, C.; Ogawa, H.; Schalk, G.; Kunii, N.; Coon, W. G.; Scharinger, J.; Guger, C.; Kamada, K.

2018-06-01

Objective. Several neuroimaging studies have demonstrated that the ventral temporal cortex contains specialized regions that process visual stimuli. This study investigated the spatial and temporal dynamics of electrocorticographic (ECoG) responses to different types and colors of visual stimulation that were presented to four human participants, and demonstrated a real-time decoder that detects and discriminates responses to untrained natural images. Approach. ECoG signals from the participants were recorded while they were shown colored and greyscale versions of seven types of visual stimuli (images of faces, objects, bodies, line drawings, digits, and kanji and hiragana characters), resulting in 14 classes for discrimination (experiment I). Additionally, a real-time system asynchronously classified ECoG responses to faces, kanji and black screens presented via a monitor (experiment II), or to natural scenes (i.e. the face of an experimenter, natural images of faces and kanji, and a mirror) (experiment III). Outcome measures in all experiments included the discrimination performance across types based on broadband γ activity. Main results. Experiment I demonstrated an offline classification accuracy of 72.9% when discriminating among the seven types (without color separation). Further discrimination of grey versus colored images reached an accuracy of 67.1%. Discriminating all colors and types (14 classes) yielded an accuracy of 52.1%. In experiment II and III, the real-time decoder correctly detected 73.7% responses to face, kanji and black computer stimuli and 74.8% responses to presented natural scenes. Significance. Seven different types and their color information (either grey or color) could be detected and discriminated using broadband γ activity. Discrimination performance maximized for combined spatial-temporal information. The discrimination of stimulus color information provided the first ECoG-based evidence for color-related population-level cortical broadband γ responses in humans. Stimulus categories can be detected by their ECoG responses in real time within 500 ms with respect to stimulus onset.

Continuous decoding of human grasp kinematics using epidural and subdural signals

PubMed Central

Flint, Robert D.; Rosenow, Joshua M.; Tate, Matthew C.; Slutzky, Marc W.

2017-01-01

Objective Restoring or replacing function in paralyzed individuals will one day be achieved through the use of brain-machine interfaces (BMIs). Regaining hand function is a major goal for paralyzed patients. Two competing prerequisites for the widespread adoption of any hand neuroprosthesis are: accurate control over the fine details of movement, and minimized invasiveness. Here, we explore the interplay between these two goals by comparing our ability to decode hand movements with subdural and epidural field potentials. Approach We measured the accuracy of decoding continuous hand and finger kinematics during naturalistic grasping motions in five human subjects. We recorded subdural surface potentials (electrocorticography; ECoG) as well as with epidural field potentials (EFPs), with both standard- and high-resolution electrode arrays. Main results In all five subjects, decoding of continuous kinematics significantly exceeded chance, using either EGoG or EFPs. ECoG decoding accuracy compared favorably with prior investigations of grasp kinematics (mean± SD grasp aperture variance accounted for was 0.54± 0.05 across all subjects, 0.75± 0.09 for the best subject). In general, EFP decoding performed comparably to ECoG decoding. The 7–20 Hz and 70–115 Hz spectral bands contained the most information about grasp kinematics, with the 70–115 Hz band containing greater information about more subtle movements. Higher-resolution recording arrays provided clearly superior performance compared to standard-resolution arrays. Significance To approach the fine motor control achieved by an intact brain-body system, it will be necessary to execute motor intent on a continuous basis with high accuracy. The current results demonstrate that this level of accuracy might be achievable not just with ECoG, but with EFPs as well. Epidural placement of electrodes is less invasive, and therefore may incur less risk of encephalitis or stroke than subdural placement of electrodes. Accurately decoding motor commands at the epidural level may be an important step towards a clinically viable brain-machine interface. PMID:27900947

A Long-Term BCI Study With ECoG Recordings in Freely Moving Rats.

PubMed

Costecalde, Thomas; Aksenova, Tetiana; Torres-Martinez, Napoleon; Eliseyev, Andriy; Mestais, Corinne; Moro, Cecile; Benabid, Alim Louis

2018-02-01

Brain Computer Interface (BCI) studies are performed in an increasing number of applications. Questions are raised about electrodes, data processing and effectors. Experiments are needed to solve these issues. To develop a simple BCI set-up to easier studies for improving the mathematical tools to process the ECoG to control an effector. We designed a simple BCI using transcranial electrodes (17 screws, three mechanically linked to create a common reference, 14 used as recording electrodes) to record Electro-Cortico-Graphic (ECoG) neuronal activities in rodents. The data processing is based on an online self-paced non-supervised (asynchronous) BCI paradigm. N-way partial least squares algorithm together with Continuous Wavelet Transformation of ECoG recordings detect signatures related to motor activities. Signature detection in freely moving rats may activate external effectors during a behavioral task, which involved pushing a lever to obtain a reward. After routine training, we showed that peak brain activity preceding a lever push (LP) to obtain food reward was located mostly in the cerebellar cortex with a higher correlation coefficient, suggesting a strong postural component and also in the occipital cerebral cortex. Analysis of brain activities provided a stable signature in the high gamma band (∼180Hz) occurring within 1500 msec before the lever push approximately around -400 msec to -500 msec. Detection of the signature from a single cerebellar cortical electrode triggers the effector with high efficiency (68% Offline and 30% Online) and rare false positives per minute in sessions about 30 minutes and up to one hour (∼2 online and offline). In summary, our results are original as compared to the rest of the literature, which involves rarely rodents, a simple BCI set-up has been developed in rats, the data show for the first time long-term, up to one year, unsupervised online control of an effector. © 2017 International Neuromodulation Society.

Source-reconstruction of the sensorimotor network from resting-state macaque electrocorticography.

PubMed

Hindriks, R; Micheli, C; Bosman, C A; Oostenveld, R; Lewis, C; Mantini, D; Fries, P; Deco, G

2018-06-07

The discovery of hemodynamic (BOLD-fMRI) resting-state networks (RSNs) has brought about a fundamental shift in our thinking about the role of intrinsic brain activity. The electrophysiological underpinnings of RSNs remain largely elusive and it has been shown only recently that electric cortical rhythms are organized into the same RSNs as hemodynamic signals. Most electrophysiological studies into RSNs use magnetoencephalography (MEG) or scalp electroencephalography (EEG), which limits the spatial resolution with which electrophysiological RSNs can be observed. Due to their close proximity to the cortical surface, electrocorticographic (ECoG) recordings can potentially provide a more detailed picture of the functional organization of resting-state cortical rhythms, albeit at the expense of spatial coverage. In this study we propose using source-space spatial independent component analysis (spatial ICA) for identifying generators of resting-state cortical rhythms as recorded with ECoG and for reconstructing their functional connectivity. Network structure is assessed by two kinds of connectivity measures: instantaneous correlations between band-limited amplitude envelopes and oscillatory phase-locking. By simulating rhythmic cortical generators, we find that the reconstruction of oscillatory phase-locking is more challenging than that of amplitude correlations, particularly for low signal-to-noise levels. Specifically, phase-lags can both be over- and underestimated, which troubles the interpretation of lag-based connectivity measures. We illustrate the methodology on somatosensory beta rhythms recorded from a macaque monkey using ECoG. The methodology decomposes the resting-state sensorimotor network into three cortical generators, distributed across primary somatosensory and primary and higher-order motor areas. The generators display significant and reproducible amplitude correlations and phase-locking values with non-zero lags. Our findings illustrate the level of spatial detail attainable with source-projected ECoG and motivates wider use of the methodology for studying resting-state as well as event-related cortical dynamics in macaque and human. Copyright © 2018. Published by Elsevier Inc.

Secukinumab provides rapid and sustained pain relief in psoriatic arthritis over 2 years: results from the FUTURE 2 study.

PubMed

McInnes, Iain B; Mease, Philip J; Schett, Georg; Kirkham, Bruce; Strand, Vibeke; Williams, Nicole; Fox, Todd; Pricop, Luminita; Jugl, Steffen M; Gandhi, Kunal K

2018-06-07

Pain is one of the most important domains affecting health-related quality of life (HRQoL) in patients with psoriatic arthritis (PsA). Secukinumab has demonstrated rapid and sustained improvements in signs and symptoms, including HRQoL, among patients with active PsA. This analysis evaluates the effect of secukinumab on patient-reported pain in PsA through 104 weeks of treatment. Pain was assessed through week 104 using clinically relevant measures, including change from baseline in a pain visual analog scale (VAS) and Short Form-36 (SF-36) bodily domain scores; proportion of patients reporting improvements equal to or better than minimum clinically meaningful differences in the pain VAS and SF-36 bodily pain domain scores; and proportion of patients with no, moderate, or extreme pain/discomfort measured by the EuroQoL 5-Dimension 3-Level Questionnaire (EQ-5D-3 L) pain item scores. Correlations of pain measures were analyzed using Pearson's correlation coefficient. Pre-specified analyses of TNF-naïve patients and patients who stopped TNF-inhibitors (TNFis) due to inadequate responses or safety/tolerability (TNF-IR patients) were performed using "as-observed data." Mean improvements from baseline in pain VAS scores were greater with secukinumab versus placebo by week 3 (- 16.9; P < 0.0001 with secukinumab 300 mg and - 12.6; P < 0.05 with secukinumab 150 mg) and sustained through week 104. SF-36 bodily pain domain scores were significantly greater with 300 mg secukinumab and secukinumab 150 mg versus placebo by week 4 (16.2 and 16.3, respectively; P < 0.0001 for both), and these changes were maintained through week 104. With both secukinumab 300 mg and secukinumab 150 mg, improvements equal to or better than the minimum clinically meaningful differences in pain VAS and SF-36 bodily pain were significant versus placebo at week 3 and week 4, respectively. At week 4, 15%, 9%, and 5% of patients receiving secukinumab 300 mg, secukinumab 150 mg, and placebo, respectively, reported "no pain/discomfort" measured by EQ-5D-3 L; these proportions increased to week 104 with both secukinumab doses. Similarly, improvements in pain measures were significant in both TNF-naïve and TNF-IR patients. Secukinumab provided rapid and sustained pain relief in PsA over 2 years of treatment. Improvements in pain were reported regardless of prior exposure to TNFis. ClinicalTrials.gov, NCT01752634 . Registered on 19 December 2012.

Prevalence and degree of sexual dysfunction in a sample of women seeking bariatric surgery

PubMed Central

Bond, Dale S.; Vithiananthan, Siva; Leahey, Tricia M.; Thomas, J. Graham; Sax, Harry C.; Pohl, Dieter; Ryder, Beth A.; Roye, G. Dean; Giovanni, Jeannine; Wing, Rena R.

2009-01-01

Background Sexual functioning is shown to be impaired in women who are obese, particularly those seeking bariatric surgery. However, most prior studies evaluating sexual function in these populations have not used validated measures. We used the validated Female Sexual Function Index (FSFI) to assess prevalence of female sexual dysfunction (FSD) in a sample of over 100 women evaluated for bariatric surgery. Methods The FSFI was administered to reportedly sexually active women during their preoperative evaluation. Scores for individual FSFI domains (desire, arousal, lubrication, orgasm, satisfaction, and pain) ranging from 0(or 1.2) to 6 were summed to produce a FSFI-total score (range = 2-36). A FSFI-total cut-off score of ≤ 26.55 was used to identify participants with FSD. Participants' FSFI- total and domain scores were compared to previously published norms available for women diagnosed with female sexual arousal disorder (FSAD) and healthy controls. Results Sixty-one of the 102 participants (59.8%) had FSFI-total scores ≤ 26.55, indicative of FSD. Older age and menopause were associated with FSD. Compared to published norms, bariatric surgery candidates had FSFI domain scores that were lower than the control group (ps <0.0001) but higher than the FSAD group (ps <0.0001), except for desire where scores were similar. Conclusion Women seeking bariatric surgery are clearly a population with substantial sexual function impairment, with 60% of participants reporting FSD. These findings highlight the need to initiate routine assessment of sexual functioning in this population and examine whether weight loss following bariatric surgery contributes to reversal of FSD. PMID:19733514

Cortical spreading depression occurs during elective neurosurgical procedures.

PubMed

Carlson, Andrew P; William Shuttleworth, C; Mead, Brittany; Burlbaw, Brittany; Krasberg, Mark; Yonas, Howard

2017-01-01

OBJECTIVE Cortical spreading depression (CSD) has been observed with relatively high frequency in the period following human brain injury, including traumatic brain injury and ischemic/hemorrhagic stroke. These events are characterized by loss of ionic gradients through massive cellular depolarization, neuronal dysfunction (depression of electrocorticographic [ECoG] activity) and slow spread (2-5 mm/min) across the cortical surface. Previous data obtained in animals have suggested that even in the absence of underlying injury, neurosurgical manipulation can induce CSD and could potentially be a modifiable factor in neurosurgical injury. The authors report their initial experience with direct intraoperative ECoG monitoring for CSD. METHODS The authors prospectively enrolled patients undergoing elective craniotomy for supratentorial lesions in cases in which the surgical procedure was expected to last > 2 hours. These patients were monitored for CSD from the time of dural opening through the time of dural closure, using a standard 1 × 6 platinum electrode coupled with an AC or full-spectrum DC amplifier. The data were processed using standard techniques to evaluate for slow potential changes coupled with suppression of high-frequency ECoG propagating across the electrodes. Data were compared with CSD validated in previous intensive care unit (ICU) studies, to evaluate recording conditions most likely to permit CSD detection, and identify likely events during the course of neurosurgical procedures using standard criteria. RESULTS Eleven patients underwent ECoG monitoring during elective neurosurgical procedures. During the periods of monitoring, 2 definite CSDs were observed to occur in 1 patient and 8 suspicious events were detected in 4 patients. In other patients, either no events were observed or artifact limited interpretation of the data. The DC-coupled amplifier system represented an improvement in stability of data compared with AC-coupled systems. Compared with more widely used postoperative ICU monitoring, there were additional challenges with artifact from saturation during bipolar cautery as well as additional noise peaks detected. CONCLUSIONS CSD can occur during elective neurosurgical procedures even in brain regions distant from the immediate operative site. ECoG monitoring with a DC-coupled full-spectrum amplifier seemed to provide the most stable signal despite significant challenges to the operating room environment. CSD may be responsible for some cases of secondary surgical injury. Though further studies on outcome related to the occurrence of these events is needed, efforts to decrease the occurrence of CSD by modification of anesthetic regimen may represent a novel target for study to increase the safety of neurosurgical procedures.

ABCs or 123s? The independent contributions of literacy and numeracy skills on health task performance among older adults

PubMed Central

Smith, Samuel G.; Curtis, Laura M.; O’Conor, Rachel; Federman, Alex D.; Wolf, Michael S.

2015-01-01

Objective To investigate the relationship between literacy and numeracy and their association with health task performance. Methods Older adults (n = 304) completed commonly used measures of literacy and numeracy. Single factor literacy and numeracy scores were calculated and used to predict performance on an established set of health self-management tasks, including: (i) responding to spoken information; (ii) comprehension of print and (iii) multimedia information; and (iv) organizing and dosing medication. Total and sub-scale scores were calculated. Results Literacy and numeracy measures were highly correlated (rs = 0.68; ps < 0.001). In multivariable models adjusted for age, gender, race, education, and comorbidity, lower literacy (β = 0.44, p < 0.001) and numeracy (β = 0.44, p < 0.001) were independently associated with worse overall task performance and all sub-scales (literacy range, β = 0.23–0.45, ps < 0.001; numeracy range, β = 0.31–0.41, ps < 0.001). Multivariable analyses with both constructs entered explained more variance in overall health task performance compared with separate literacy and numeracy models (8.2% and 10% respectively, ps < 0.001). Conclusion Literacy and numeracy were highly correlated, but independent predictors of health task performance. These skill sets are complementary and both are important for health self-management. Practice implications Self-management interventions may be more effective if they consider both literacy and numeracy skills rather than focusing on one specific ability. PMID:25936579

Bone mineral density status and frequency of osteoporosis and clinical fractures in 155 patients with psoriatic arthritis followed in a university hospital.

PubMed

Busquets, Noemi; Vaquero, Carmen Gómez; Moreno, Jesús Rodríguez; Vilaseca, Daniel Roig; Narváez, Javier; Carmona, Loreto; Nolla, Joan M

2014-01-01

To assess the bone mineral density (BMD) and the frequency of osteoporosis and clinical fractures in a large group of Spanish patients with psoriatic arthritis (PsA). BMD was determined by DXA in all the patients who were willing to participate and had peripheral PsA regularly evaluated in a tertiary university hospital. All patients underwent a physical examination and general laboratory analysis. We gathered demographic and clinical variables related with BMD and risk of fractures. We also recorded the history of clinical low impact fractures. The population of reference to calculate T-score and Z-score came from a Spanish database. One hundred and fifty-five patients were included (64 postmenopausal women, 26 premenopausal women and 65 men). The clinical forms of PsA were: 46% oligoarticular and 54% polyarticular. Mean disease duration was 13.7±9.4 years and mean ESR was 21.8±13.9mm/h; 66% of patients had received glucocorticoid treatment. We found no differences in BMD status between the patients and the Spanish general population, neither in the whole series nor in each defined subgroup. Frequency of osteoporosis was 16%; it was higher in postmenopausal women (28%) than in men (9%) or premenopausal women (4%). Frequency of clinical fractures was 13%; it accounted specially in postmenopausal women. The magnitude of the problem of osteoporosis in PsA seems to be mild. Copyright © 2013 Elsevier España, S.L. All rights reserved.

The development and utility of a novel scale that quantifies the glycemic progression toward type 1 diabetes over 6 months.

PubMed

Sosenko, Jay M; Skyler, Jay S; Beam, Craig A; Boulware, David; Mahon, Jeffrey L; Krischer, Jeffrey P; Greenbaum, Carla J; Rafkin, Lisa E; Matheson, Della; Herold, Kevan C; Palmer, Jerry P

2015-05-01

We developed a scale to serve as a potential end point for 6-month glycemic progression (PS6M) toward type 1 diabetes (T1D) in autoantibody-positive relatives of individuals with T1D. The PS6M was developed from Diabetes Prevention Trial-Type 1 (DPT-1) data and tested in the TrialNet Pathway to Prevention Study (PTP). It is the difference between 6-month glucose sum values (30-120 min oral glucose tolerance test values) and values predicted for nonprogressors. The PS6M predicted T1D in the PTP (P < 0.001). The area under the receiver operating chacteristic curve was greater (P < 0.001) for the PS6M than for the baseline-to-6-month difference. PS6M values were higher in those with two or more autoantibodies, 30-0 min C-peptide values <2.00 ng/mL, or DPT-1 Risk Scores >7.00 (P < 0.001 for all). The PS6M is an indicator of short-term glycemic progression to T1D that could be a useful tool for assessing preventive treatments and biomarkers. © 2015 by the American Diabetes Association. Readers may use this article as long as the work is properly cited, the use is educational and not for profit, and the work is not altered.

Twelve-month prospective cohort study of patients with severe traumatic brain injury and their relatives: Coping, satisfaction with life and neurological functioning.

PubMed

Haller, Chiara S

2017-01-01

To examine the associations between the functioning of patients with severe traumatic brain injury (TBI), and their relatives' coping style and quality of life across 12 months post-injury. Prospective, population-based cohort study assessing 188 patients with severe TBI (Abbreviated Injury Scale of the head region [HAIS] score >3), and their relatives, 3, 6 and 12 months post-injury. Data were drawn from a larger national study run in Switzerland (2007-2011). Patient assessment: Glasgow Coma Outcome Scale Extended (GOSE), Patient Competency Rating Scale for Neurorehabilitation (PCRS-NR). Relative assessment: Health-Related Quality of Life (HRQoL; 12-item short form health survey [SF-12]), Coping Inventory for Stressful Situations (CISS). Mixed linear models were run separately for ages >50 and ≤50 (i.e. bimodal distribution). Patients' GOSE score was associated with relatives' reported mental SF-12 scores across age (ps < 0.01). Relatives' CISS was associated with patients' PCRS score (age > 50 years): Total and cognitive functioning decreased as emotion-oriented coping increased (ps = 0.01), while interpersonal functioning increased as task-oriented coping increased (p = 0.01) and decreased as avoidance-oriented coping increased (p = 0.02). Patients' functioning and relatives' mental HRQoL and coping strategies are associated with each other.

A systematic review of measurement properties of patient reported outcome measures in psoriatic arthritis: A GRAPPA-OMERACT initiative.

PubMed

Højgaard, Pil; Klokker, Louise; Orbai, Ana-Maria; Holmsted, Kim; Bartels, Else M; Leung, Ying Ying; Goel, Niti; de Wit, Maarten; Gladman, Dafna D; Mease, Philip; Dreyer, Lene; Kristensen, Lars E; FitzGerald, Oliver; Tillett, William; Gossec, Laure; Helliwell, Philip; Strand, Vibeke; Ogdie, Alexis; Terwee, Caroline B; Christensen, Robin

2018-04-01

An updated psoriatic arthritis (PsA) core outcome set (COS) for randomized controlled trials (RCTs) was endorsed at the Outcome Measures in Rheumatology (OMERACT) meeting in 2016. To synthesize the evidence on measurement properties of patient reported outcome measures (PROMs) for PsA and thereby contribute to development of a PsA core outcome measurement set (COMS) as described by the OMERACT Filter 2.0. A systematic literature search was performed in EMBASE, MEDLINE and PsycINFO on Jan 1, 2017 to identify full-text articles with an aim of assessing the measurement properties of PROMs in PsA. Two independent reviewers rated the quality of studies using the COnsensus based standards for the Selection of health Measurement INstruments (COSMIN) checklist, and performed a qualitative evidence synthesis. Fifty-five studies were included in the systematic review. Forty-four instruments and a total of 89 scales were analyzed. PROMs measuring COS domains with at least fair quality evidence for good validity and reliability (and no evidence for poor properties) included the Stockerau Activity Score for PsA (German), Psoriasis Symptom Inventory, visual analogue scale for Patient Global, 36 Item Short Form Health Survey Physical Function subscale, Health Assessment Questionnaire Disability Index, Bath Ankylosing Spondylitis Functional Index, PsA Impact of Disease questionnaire, PsA Quality of Life questionnaire, VITACORA-19, Functional Assessment of Chronic Illness Therapy Fatigue scale and Social Role Participation Questionnaire. At least one PROM with some evidence for aspects of validity and reliability was available for six of the eight mandatory domains of the PsA COS. Copyright © 2018 Elsevier Inc. All rights reserved.

Stratification of pseudoprogression and true progression of glioblastoma multiform based on longitudinal diffusion tensor imaging without segmentation

PubMed Central

Qian, Xiaohua; Tan, Hua; Zhang, Jian; Zhao, Weilin; Chan, Michael D.; Zhou, Xiaobo

2016-01-01

Purpose: Pseudoprogression (PsP) can mimic true tumor progression (TTP) on magnetic resonance imaging in patients with glioblastoma multiform (GBM). The phenotypical similarity between PsP and TTP makes it a challenging task for physicians to distinguish these entities. So far, no approved biomarkers or computer-aided diagnosis systems have been used clinically for this purpose. Methods: To address this challenge, the authors developed an objective classification system for PsP and TTP based on longitudinal diffusion tensor imaging. A novel spatio-temporal discriminative dictionary learning scheme was proposed to differentiate PsP and TTP, thereby avoiding segmentation of the region of interest. The authors constructed a novel discriminative sparse matrix with the classification-oriented dictionary learning approach by excluding the shared features of two categories, so that the pooled features captured the subtle difference between PsP and TTP. The most discriminating features were then identified from the pooled features by their feature scoring system. Finally, the authors stratified patients with GBM into PsP and TTP by a support vector machine approach. Tenfold cross-validation (CV) and the area under the receiver operating characteristic (AUC) were used to assess the robustness of the developed system. Results: The average accuracy and AUC values after ten rounds of tenfold CV were 0.867 and 0.92, respectively. The authors also assessed the effects of different methods and factors (such as data types, pooling techniques, and dimensionality reduction approaches) on the performance of their classification system which obtained the best performance. Conclusions: The proposed objective classification system without segmentation achieved a desirable and reliable performance in differentiating PsP from TTP. Thus, the developed approach is expected to advance the clinical research and diagnosis of PsP and TTP. PMID:27806598

Double-adjustment in propensity score matching analysis: choosing a threshold for considering residual imbalance.

PubMed

Nguyen, Tri-Long; Collins, Gary S; Spence, Jessica; Daurès, Jean-Pierre; Devereaux, P J; Landais, Paul; Le Manach, Yannick

2017-04-28

Double-adjustment can be used to remove confounding if imbalance exists after propensity score (PS) matching. However, it is not always possible to include all covariates in adjustment. We aimed to find the optimal imbalance threshold for entering covariates into regression. We conducted a series of Monte Carlo simulations on virtual populations of 5,000 subjects. We performed PS 1:1 nearest-neighbor matching on each sample. We calculated standardized mean differences across groups to detect any remaining imbalance in the matched samples. We examined 25 thresholds (from 0.01 to 0.25, stepwise 0.01) for considering residual imbalance. The treatment effect was estimated using logistic regression that contained only those covariates considered to be unbalanced by these thresholds. We showed that regression adjustment could dramatically remove residual confounding bias when it included all of the covariates with a standardized difference greater than 0.10. The additional benefit was negligible when we also adjusted for covariates with less imbalance. We found that the mean squared error of the estimates was minimized under the same conditions. If covariate balance is not achieved, we recommend reiterating PS modeling until standardized differences below 0.10 are achieved on most covariates. In case of remaining imbalance, a double adjustment might be worth considering.

Reliability and validity of procedure-based assessments in otolaryngology training.

PubMed

Awad, Zaid; Hayden, Lindsay; Robson, Andrew K; Muthuswamy, Keerthini; Tolley, Neil S

2015-06-01

To investigate the reliability and construct validity of procedure-based assessment (PBA) in assessing performance and progress in otolaryngology training. Retrospective database analysis using a national electronic database. We analyzed PBAs of otolaryngology trainees in North London from core trainees (CTs) to specialty trainees (STs). The tool contains six multi-item domains: consent, planning, preparation, exposure/closure, technique, and postoperative care, rated as "satisfactory" or "development required," in addition to an overall performance rating (pS) of 1 to 4. Individual domain score, overall calculated score (cS), and number of "development-required" items were calculated for each PBA. Receiver operating characteristic analysis helped determine sensitivity and specificity. There were 3,152 otolaryngology PBAs from 46 otolaryngology trainees analyzed. PBA reliability was high (Cronbach's α 0.899), and sensitivity approached 99%. cS correlated positively with pS and level in training (rs : +0.681 and +0.324, respectively). ST had higher cS and pS than CT (93% ± 0.6 and 3.2 ± 0.03 vs. 71% ± 3.1 and 2.3 ± 0.08, respectively; P < .001). cS and pS increased from CT1 to ST8 showing construct validity (rs : +0.348 and +0.354, respectively; P < .001). The technical skill domain had the highest utilization (98% of PBAs) and was the best predictor of cS and pS (rs : +0.96 and +0.66, respectively). PBA is reliable and valid for assessing otolaryngology trainees' performance and progress at all levels. It is highly sensitive in identifying competent trainees. The tool is used in a formative and feedback capacity. The technical domain is the best predictor and should be given close attention. NA. © 2014 The American Laryngological, Rhinological and Otological Society, Inc.

Effect of dialyzer membrane materials on survival in chronic hemodialysis patients: Results from the annual survey of the Japanese Nationwide Dialysis Registry

PubMed Central

Hamano, Takayuki; Wada, Atsushi; Nakai, Shigeru; Masakane, Ikuto

2017-01-01

Background Little information is available regarding which type of dialyzer membrane results in good prognosis in patients on chronic hemodialysis. Therefore, we conducted a cohort study from a nationwide registry of hemodialysis patients in Japan to establish the association between different dialyzer membranes and mortality rates. Methods We followed 142,412 patients on maintenance hemodialysis (female, 39.1%; mean age, 64.8 ± 12.3 years; median dialysis duration, 7 [4–12] years) for a year from 2008 to 2009. We included patients treated with seven types of high-flux dialyzer membranes at baseline, including cellulose triacetate (CTA), ethylene vinyl alcohol (EVAL), polyacrylonitrile (PAN), polyester polymer alloy (PEPA), polyethersulfone (PES), polymethylmethacrylate (PMMA), and polysulfone (PS). Cox regression was used to estimate the association between baseline dialyzers and all-cause mortality as hazard ratios (HRs) and 95% confidence intervals for 1-year mortality adjusting for potential confounders, and propensity score matching analysis was performed. Results The distribution of patients treated with each membrane was as follows: PS (56.0%), CTA (17.3%), PES (12.0%), PEPA (7.5%), PMMA (4.9%), PAN (1.2%), and EVAL (1.1%). When data were adjusted using basic factors, with PS as a reference group, the mortality rate was significantly higher in all groups except for the PES group. When data were further adjusted for dialysis-related factors, HRs were significantly higher for the CTA, EVAL, and PEPA groups. When the data were further adjusted for nutrition-and inflammation-related factors, HRs were significantly lower for the PMMA and PES groups compared with the PS group. After propensity score matching, HRs were significantly lower for the PMMA group than for the PS group. Conclusion The results suggest that the use of different membrane types may affect mortality in hemodialysis patients. However, further long-term prospective studies are needed to clarify these findings, including whether the use of the PMMA membrane can improve prognosis. PMID:28910324

Effect of dialyzer membrane materials on survival in chronic hemodialysis patients: Results from the annual survey of the Japanese Nationwide Dialysis Registry.

PubMed

Abe, Masanori; Hamano, Takayuki; Wada, Atsushi; Nakai, Shigeru; Masakane, Ikuto

2017-01-01

Little information is available regarding which type of dialyzer membrane results in good prognosis in patients on chronic hemodialysis. Therefore, we conducted a cohort study from a nationwide registry of hemodialysis patients in Japan to establish the association between different dialyzer membranes and mortality rates. We followed 142,412 patients on maintenance hemodialysis (female, 39.1%; mean age, 64.8 ± 12.3 years; median dialysis duration, 7 [4-12] years) for a year from 2008 to 2009. We included patients treated with seven types of high-flux dialyzer membranes at baseline, including cellulose triacetate (CTA), ethylene vinyl alcohol (EVAL), polyacrylonitrile (PAN), polyester polymer alloy (PEPA), polyethersulfone (PES), polymethylmethacrylate (PMMA), and polysulfone (PS). Cox regression was used to estimate the association between baseline dialyzers and all-cause mortality as hazard ratios (HRs) and 95% confidence intervals for 1-year mortality adjusting for potential confounders, and propensity score matching analysis was performed. The distribution of patients treated with each membrane was as follows: PS (56.0%), CTA (17.3%), PES (12.0%), PEPA (7.5%), PMMA (4.9%), PAN (1.2%), and EVAL (1.1%). When data were adjusted using basic factors, with PS as a reference group, the mortality rate was significantly higher in all groups except for the PES group. When data were further adjusted for dialysis-related factors, HRs were significantly higher for the CTA, EVAL, and PEPA groups. When the data were further adjusted for nutrition-and inflammation-related factors, HRs were significantly lower for the PMMA and PES groups compared with the PS group. After propensity score matching, HRs were significantly lower for the PMMA group than for the PS group. The results suggest that the use of different membrane types may affect mortality in hemodialysis patients. However, further long-term prospective studies are needed to clarify these findings, including whether the use of the PMMA membrane can improve prognosis.

Characterization of patients receiving palliative chemo- and radiotherapy during end of life at a regional cancer center in Norway.

PubMed

Anshushaug, Malin; Gynnild, Mari Aas; Kaasa, Stein; Kvikstad, Anne; Grønberg, Bjørn H

2015-03-01

Many cancer patients receive chemotherapy and radiotherapy their last 30 days [end of life (EOL)]. The benefit is questionable and side effects are common. The aim of this study was to investigate what characterized the patients who received chemo- and radiotherapy during EOL, knowledge that might be used to improve practice. Patients dead from cancer in 2005 and 2009 were analyzed. Data were collected from hospital medical records. When performance status (PS) was not stated, PS was estimated from other information in the records. A Glasgow Prognostic Score (GPS) of 0, 1 or 2 was assessed from blood values (CRP and albumin). A higher score is associated with a shorter prognosis. In total 616 patients died in 2005; 599 in 2009. Among the 723 analyzed, median age was 71; 42% had metastases at diagnosis (synchronous metastases); 53% had PS 2 and 16% PS 3-4 at the start of last cancer therapy. GPS at the start of last cancer therapy was assessable in 70%; of these, 26% had GPS 1 and 35% GPS 2. Overall, 10% received chemotherapy and 8% radiotherapy during EOL. The proportions varied significantly between the different types of cancer. Multivariate analyses revealed that those at age<70 years, GPS 2, no contact with our Palliative Care Unit and synchronous metastases received most chemotherapy the last 30 days. PS 3-4, GPS 2 and synchronous metastases were strongest associated with radiotherapy the last 30 days. Ten percent received chemotherapy and 8% radiotherapy the last 30 days of life. GPS 2 and synchronous metastases were most significantly associated with cancer therapy the last 30 days of life, indicating that in general, patients with the shortest survival time after diagnosis of cancer received more chemo- and radiotherapy during EOL than other patients.

Longitudinal psychometric attributes, responsiveness, and importance of change: An approach using the SCOPA-Psychosocial questionnaire.

PubMed

Martínez-Martin, Pablo; Carod-Artal, Francisco Javier; da Silveira Ribeiro, Luciola; Ziomkowski, Sofia; Vargas, Antonio Pedro; Kummer, Wladimir; Mesquita, Hudson Mourão

2008-08-15

The objective of this study was to illustrate the analysis of longitudinal validity, responsiveness, and importance of change, using the SCOPA-Psychosocial Questionnaire (SCOPA-PS) as a source of empirical data. Sixty-seven patients with PD in Hoehn and Yahr (HY) stage 2 were followed up for 1 year and assessed by means of the Schwab and England Scale, Unified PD Rating Scale (UPDRS), Hospital Anxiety and Depression Scale (HADS), PDQ-39, and SCOPA-PS. A range of methods was applied to enable each of the target attributes to be analyzed from different conceptual stances. The SCOPA-PS displayed satisfactory acceptability (no floor or ceiling effect), internal consistency (alpha = 0.80-0.84), convergent validity (r(S) = 0.70-0.82 with PDQ-39), and precision (SEM = 8.80), both at baseline and at the end of follow-up. The threshold value for significant change ranged from 17.25 (1.96 SEM) to 24.39 (Smallest real difference and Reliable change index). Threshold values for a clinically meaningful change were 0.73-1.26 (effect size, standardized response mean, responsiveness statistic). Change in SCOPA-PS scores correlated strongly with change in total UPDRS, HADS, and PDQ-39 scores, and reliably detected 70% of cases that worsened according to the PDQ-39. The minimally important change (MIC) for "minimally impaired" patients as per the PDQ39 was 8.30-9.10 points. Indices such as 1.96 SEM, effect size, and correlation with the change in other measures provide useful information about different concepts of responsiveness. The MIC should be determined for each specific setting, using distribution- and anchor-based methods. The SCOPA-PS showed satisfactory longitudinal attributes and responsiveness in stage-2 Brazilian patients with PD across 1 year of follow-up. (c) 2008 Movement Disorder Society.

C-reactive protein as an adverse prognostic marker for men with castration-resistant prostate cancer (CRPC): confirmatory results

PubMed Central

Prins, Renee C.; Rademacher, Brooks L.; Mongoue-Tchokote, Solange; Alumkal, Joshi J.; Graff, Julie N.; Eilers, Kristine M.; Beer, Tomasz M.

2010-01-01

We previously reported that higher serum concentrations of C-reactive protein (CRP) are associated with shorter survival in men with castration-resistant prostate cancer (CRPC). To confirm this finding in an independent data set, we used 119 CRPC patients enrolled in 6 phase II clinical trials and examined the relationship of CRP, alkaline phosphatase, hemoglobin, age, ECOG PS, and prostate specific antigen (PSA) with survival. Median follow-up was 19.7 months (0.9–98.5 months) and 89% have died. After analyzing the form of the risk function using the generalized additive model method, univariate and multivariate Cox proportional hazard models were used to assess associations between baseline individual categorical and continuous variables. Quartiles of CRP were: 1: 0–1.0, 1.1–4.9, 5.0–17.0, and 17.1 to 311 mg/L. In a Cox multivariate model, log2(CRP) (HR 1.106 p=0.013) as well as hemoglobin and alkaline phosphatase were independently associated with survival, confirming that higher CRP is associated with shorter survival in CRPC. Since CRP is a marker of inflammation, this finding suggests that inflammation may play an important role in the natural history of advanced prostate cancer. CRP is a readily measurable biomarker that has the potential to improve prognostic models and should be validated in a prospective clinical trial. PMID:20207556

Risk of Progression and Survival in Multiple Myeloma Relapsing After Therapy with IMiDs and Bortezomib: A Multicenter International Myeloma Working Group Study

PubMed Central

Kumar, Shaji; Lee, Jae Hoon; Lahuerta, Juan J.; Morgan, Gareth; Richardson, Paul G.; Crowley, John; Haessler, Jeff; Feather, John; Hoering, Antje; Moreau, Philippe; LeLeu, Xavier; Hullin, Cyrille; Klein, Saskia K.; Sonneveld, Pieter; Siegel, David; Bladé, Joan; Goldschmidt, Hartmut; Jagannath, Sundar; San Miguel, Jesus; Orlowski, Robert; Palumbo, Antonio; Sezer, Orhan; Durie, Brian G.M.

2014-01-01

Promising new drugs are being evaluated for treatment of multiple myeloma (MM), but their impact should be measured against the expected outcome in patients failing current therapies. However, the natural history of relapsed disease in the current era remains unclear. We studied 286 patients with relapsed MM, who were refractory to bortezomib and were relapsed, refractory, or ineligible, to an IMiD (Immunomodulatory Drug), with measurable disease and ECOG PS of 0, 1 or 2. The date patients satisfied the entry criteria was defined as time zero (T0). The median age at diagnosis was 58 years and time from diagnosis to T0 was 3.3 years. Following T0, 213 (74%) patients had a treatment recorded with one or more regimens (median=1; range 0-8). The first regimen contained bortezomib in 55 (26%) patients and an IMiD in 70 (33%). A minor response or better was seen to at least one therapy after T0 in 94 patients (51%) including >=partial response in 69 (38%). The median overall survival and event free survival from T0 were 9 and 5 months respectively. This study confirms the poor outcome once patients become refractory to current treatments. The results provide context for interpreting ongoing trials of new drugs. PMID:21799510

Patients with advanced hepatocellular carcinoma need a personalized management: A lesson from clinical practice.

PubMed

Giannini, Edoardo Giovanni; Bucci, Laura; Garuti, Francesca; Brunacci, Matteo; Lenzi, Barbara; Valente, Matteo; Caturelli, Eugenio; Cabibbo, Giuseppe; Piscaglia, Fabio; Virdone, Roberto; Felder, Martina; Ciccarese, Francesca; Foschi, Francesco Giuseppe; Sacco, Rodolfo; Svegliati Baroni, Gianluca; Farinati, Fabio; Rapaccini, Gian Lodovico; Olivani, Andrea; Gasbarrini, Antonio; Di Marco, Maria; Morisco, Filomena; Zoli, Marco; Masotto, Alberto; Borzio, Franco; Benvegnù, Luisa; Marra, Fabio; Colecchia, Antonio; Nardone, Gerardo; Bernardi, Mauro; Trevisani, Franco

2018-05-01

The Barcelona Clinic Liver Cancer (BCLC) advanced stage (BCLC C) of hepatocellular carcinoma (HCC) includes a heterogeneous population, where sorafenib alone is the recommended treatment. In this study, our aim was to assess treatment and overall survival (OS) of BCLC C patients subclassified according to clinical features (performance status [PS], macrovascular invasion [MVI], extrahepatic spread [EHS] or MVI + EHS) determining their allocation to this stage. From the Italian Liver Cancer database, we analyzed 835 consecutive BCLC C patients diagnosed between 2008 and 2014. Patients were subclassified as: PS1 alone (n = 385; 46.1%), PS2 alone (n = 146; 17.5%), MVI (n = 224; 26.8%), EHS (n = 51; 6.1%), and MVI + EHS (n = 29; 3.5%). MVI, EHS, and MVI + EHS patients had larger and multifocal/massive HCCs and higher alpha-fetoprotein (AFP) levels than PS1 and PS2 patients. Median OS significantly declined from PS1 (38.6 months) to PS2 (22.3 months), EHS (11.2 months), MVI (8.2 months), and MVI + EHS (3.1 months; P < 0.001). Among MVI patients, OS was longer in those with peripheral than with central (portal trunk) MVI (11.2 vs. 7.1 months; P = 0.005). The most frequent treatments were: curative approaches in PS1 (39.7%), supportive therapy in PS2 (41.8%), sorafenib in MVI (39.3%) and EHS (37.3%), and best supportive care in MVI + EHS patients (51.7%). Independent prognostic factors were: Model for End-stage Liver Disease score, Child-Pugh class, ascites, platelet count, albumin, tumor size, MVI, EHS, AFP levels, and treatment type. BCLC C stage does not identify patients homogeneous enough to be allocated to a single stage. PS1 alone is not sufficient to include a patient into this stage. The remaining patients should be subclassified according to PS and tumor features, and new patient-tailored therapeutic indications are needed. (Hepatology 2018;67:1784-1796). © 2017 by the American Association for the Study of Liver Diseases.

Multiple active myofascial trigger points and pressure pain sensitivity maps in the temporalis muscle are related in women with chronic tension type headache.

PubMed

Fernández-de-las-Peñas, César; Caminero, Ana B; Madeleine, Pascal; Guillem-Mesado, Amparo; Ge, Hong-You; Arendt-Nielsen, Lars; Pareja, Juan A

2009-01-01

To describe the common locations of active trigger points (TrPs) in the temporalis muscle and their referred pain patterns in chronic tension type headache (CTTH), and to determine if pressure sensitivity maps of this muscle can be used to describe the spatial distribution of active TrPs. Forty women with CTTH were included. An electronic pressure algometer was used to assess pressure pain thresholds (PPT) from 9 points over each temporalis muscle: 3 points in the anterior, medial and posterior part, respectively. Both muscles were examined for the presence of active TrPs over each of the 9 points. The referred pain pattern of each active TrP was assessed. Two-way analysis of variance detected significant differences in mean PPT levels between the measurement points (F=30.3; P<0.001), but not between sides (F=2.1; P=0.2). PPT scores decreased from the posterior to the anterior column (P<0.001). No differences were found in the number of active TrPs (F=0.3; P=0.9) between the dominant side the nondominant side. Significant differences were found in the distribution of the active TrPs (chi2=12.2; P<0.001): active TrPs were mostly found in the anterior column and in the middle of the muscle belly. The analysis of variance did not detect significant differences in the referred pain pattern between active TrPs (F=1.1, P=0.4). The topographical pressure pain sensitivity maps showed the distinct distribution of the TrPs indicated by locations with low PPTs. Multiple active TrPs in the temporalis muscle were found, particularly in the anterior column and in the middle of the muscle belly. Bilateral posterior to anterior decreased distribution of PPTs in the temporalis muscle in women with CTTH was found. The locations of active TrPs in the temporalis muscle corresponded well to the muscle areas with lower PPT, supporting the relationship between multiple active muscle TrPs and topographical pressure sensitivity maps in the temporalis muscle in women with CTTH.

Prenatal stress increases adult vulnerability to cocaine reward without affecting pubertal anxiety or novelty response.

PubMed

Pastor, Verónica; Pallarés, María Eugenia; Antonelli, Marta C

2018-02-26

Prenatal stress (PS) induces long-lasting molecular alterations in brain circuits of the offspring and increases the propensity to develop neuropsychiatric diseases during adulthood, including mood disorders and drug addiction. A major goal of this study was to assess the impact of PS on pubertal behaviour and adult vulnerability to cocaine-induced conditioning place preference (CPP). We therefore evaluated pubertal novelty response and anxiety-like behaviour in control (C) and PS rats, and then, we examined cocaine-induced CPP in those animals during adulthood. We found no differences between C and PS groups on pubertal behaviour, however, only PS rats showed a significant cocaine-induced CPP. To further analyze our results, we classified cocaine-treated rats regarding their CPP score in Low CPP or High CPP and we then analysed their pubertal behaviour. We found different relations of anxiety-like behaviour to cocaine reward as a function of PS exposure: for C group, High CPP and Low CPP had shown similar levels of anxiety-like behaviour at puberty; on the contrary, for PS group, High CPP had shown lower anxiety-like behaviour than Low CPP rats. This study underscores the importance of considering prenatal exposure to stress when analysing the relationship between anxiety and cocaine vulnerability. Moreover, the evaluation of behavioural traits at puberty opens the possibility of early intervention and will allow the development of specific prevention strategies to avoid the devastating consequences of drug addiction later in life. Copyright © 2017 Elsevier B.V. All rights reserved.

Impact of CyberKnife Radiosurgery on Overall Survival and Various Parameters of Patients with 1-3 versus ≥ 4 Brain Metastases.

PubMed

Murovic, Judith; Ding, Victoria; Han, Summer S; Adler, John R; Chang, Steven D

2017-10-24

Introduction This study's objective is to compare the overall survivals (OSs) and various parameters of patients with 1-3 versus ≥ 4 brain metastases post-CyberKnife radiosurgery (CKRS) (Accuray, Sunnyvale, California) alone. Methods Charts of 150 patients, from 2009-2014, treated with only CKRS for brain metastases were reviewed retrospectively for overall survival (OS) and patient, tumor, and imaging characteristics. Parameters included demographics, Eastern Cooperative Oncology Group (ECOG) performance scores, number and control of extracranial disease (ECD) sites, cause of death (COD), histology, tumor volume (TV), and post-CKRS whole brain radiotherapy (WBRT). The imaging characteristics assessed were time of complete response (CR), partial response (PR), stable imaging or local failure (LF), and distal brain failure (DBF). Patients and their data were divided into those with 1-3 (group 1) versus ≥ 4 brain metastases (group 2). For each CR and LF patient, absolute neutrophil count (ANC), absolute lymphocyte count (ALC)), and ANC/ALC ratio (NLR) were obtained, when available, at the time of CKRS. Results Both group 1 and group 2 had a median OS of 13 months. The patient median age for the 115 group 1 patients versus the 35 group 2 patients was 62 versus 56 years. Group 1 had slightly more males and group 2, females. The predominant ECOG score for each group was 1 and the number of ECD sites was one and two, respectively. Uncontrolled ECD occurred in the majority of both group 1 and group 2 patients. The main COD was ECD in both groups. The prevalent tumor histology for groups 1 and 2 was non-small cell lung carcinoma. Median TVs were 1.08 cc versus 1.42 cc for groups 1 and 2, respectively. The majority of patients in both groups did not undergo post-CKRS WBRT. Imaging outcomes were LC (CR, PR, or stable imaging) in 93 (80.9%) and 26 (74.3%) group 1 and 2 patients, of whom 32 (27.8%) and six (17.1%) had CR; 38 (33.0%) and 18 (51.4%), PR and 23 (20.0%) and two (5.7%), stable imaging; LF was the outcome in 22 (19.1%) and nine (25.7%) patients, and DBF occurred in 62 (53.9%) and 21 (60.0%), respectively. Uni- and multivariable analyses showed the independent parameters of a lower ECOG score, a greater number of ECD sites and uncontrolled ECD were significantly associated with greater mortality risk with and without accounting for other covariates. At CKRS, 19 group 1 and 2 CR patients had a mean ANC of 5.88 K/µL and a mean ALC of 1.31 K/µL and 13 (68%) of 19 had NLRs ≤ five, while 11 with LFs had a mean ANC of 5.22 K/µL and a mean ALC of 0.93 K/µL and seven (64%) had NLRs > five. An NLR ≤ five and high ALC was associated with a CR and an NLR > five and a low ALC with an LF. Conclusions Median OS post-CKRS was 13 months for both patients with 1-3 brain metastases and with ≥ 4. This is the only study in the literature to evaluate OS in patients with 1-3 and ≥ 4 brain metastases who were treated with CKRS alone. For groups 1 and 2 patients combined, 119 (79.3%) had LC and 38 (25.3%) had CR. The ANC, ALC, and NLR values are likely predictive of CR and LF outcomes.

Perceived stress among Primary Health Care Professionals in Brazil.

PubMed

Leonelli, Luiz Bernardo; Andreoni, Solange; Martins, Patricia; Kozasa, Elisa Harumi; Salvo, Vera Lúcia de; Sopezki, Daniela; Montero-Marin, Jesus; Garcia-Campayo, Javier; Demarzo, Marcelo Marcos Piva

2017-01-01

To evaluate the perceived stress (PS) of professionals in Primary Health Care and its association with the characteristics of the teams in the Family Health Program (FHP). The association between PS and self-referred morbidity was also investigated. This is a cross-sectional study conducted with 450 employees from 60 teams in 12 Basic Health Units (BHUs) in a region of São Paulo. The differences in the total score in the Perceived Stress Scale were evaluated through multiple linear regression models. Higher levels of PS were observed in those who had been working for one year or more in the same team, in the categories of doctors, nurses and community health workers, females, non-religious, and in BHU professionals in incomplete teams (absence of a physician). Lower perceived stress was found in widowers. It was observed that individuals with higher levels of PS have higher chances of reporting chronic health problems. It can be concluded that the perception of stress in this population is associated with individual, professional factors, and the composition of teams in healthcare units.

The role of executive functions in the pragmatic skills of children age 4–5

PubMed Central

Blain-Brière, Bénédicte; Bouchard, Caroline; Bigras, Nathalie

2014-01-01

Several studies suggest that pragmatic skills (PS) (i.e., social communication) deficits may be linked to executive dysfunction (i.e., cognitive processes required for the regulation of new and complex behaviors) in patients with frontal brain injuries. If impairment of executive functions (EF) causes PS deficits in otherwise healthy adults, could this mean that EF are necessary for the normal functioning of PS, even more so than cognitive maturation? If so, children with highly developed EF should exhibit higher levels of PS. This study aimed to examine the link between EF and PS among normally developing children. A secondary goal was to compare this relationship to that between intellectual quotient (IQ) and PS in order to determine which predictor explained the most variance. Participants were 70 French-speaking preschool children (3;10–5;7 years old). The PS coding system, an observational tool developed for this study, was used to codify the children's PS during a semi-structured conversation with a research assistant. Five types of EF processes were evaluated: self-control, inhibition, flexibility, working memory and planning. IQ was estimated by tallying the scores on a receptive vocabulary test and a visuoconstructive abilities test. The results of the test of differences between correlation coefficients suggest that EF contributed significantly more than IQ to the PS exhibited by preschoolers during conversation. More specifically, higher inhibition skills were correlated with a decrease in talkativeness and assertiveness. EF also appeared to foster quality of speech by promoting the ability to produce fluid utterances, free of unnecessary repetition or hesitation. Moreover, children with a high working memory capacity were more likely to formulate contingent answers and produce utterances that could be clearly understood by the interlocutor. Overall, these findings help us better understand how EF may assist children in everyday social interactions. PMID:24688480

Validation of the CAchexia SCOre (CASCO). Staging Cancer Patients: The Use of miniCASCO as a Simplified Tool

PubMed Central

Argilés, Josep M.; Betancourt, Angelica; Guàrdia-Olmos, Joan; Peró-Cebollero, Maribel; López-Soriano, Francisco J.; Madeddu, Clelia; Serpe, Roberto; Busquets, Sílvia

2017-01-01

The CAchexia SCOre (CASCO) was described as a tool for the staging of cachectic cancer patients. The aim of this study is to show the metric properties of CASCO in order to classify cachectic cancer patients into three different groups, which are associated with a numerical scoring. The final aim was to clinically validate CASCO for its use in the classification of cachectic cancer patients in clinical practice. We carried out a case -control study that enrolled prospectively 186 cancer patients and 95 age-matched controls. The score includes five components: (1) body weight loss and composition, (2) inflammation/metabolic disturbances/immunosuppression, (3) physical performance, (4) anorexia, and (5) quality of life. The present study provides clinical validation for the use of the score. In order to show the metric properties of CASCO, three different groups of cachectic cancer patients were established according to the results obtained with the statistical approach used: mild cachexia (15 ≤ × ≤ 28), moderate cachexia (29 ≤ × ≤ 46), and severe cachexia (47 ≤ × ≤ 100). In addition, a simplified version of CASCO, MiniCASCO (MCASCO), was also presented and it contributes as a valid and easy-to-use tool for cachexia staging. Significant statistically correlations were found between CASCO and other validated indexes such as Eastern Cooperative Oncology Group (ECOG) and the subjective diagnosis of cachexia by specialized oncologists. A very significant estimated correlation between CASCO and MCASCO was found that suggests that MCASCO might constitute an easy and valid tool for the staging of the cachectic cancer patients. CASCO and MCASCO provide a new tool for the quantitative staging of cachectic cancer patients with a clear advantage over previous classifications. PMID:28261113

Validation of the CAchexia SCOre (CASCO). Staging Cancer Patients: The Use of miniCASCO as a Simplified Tool.

PubMed

Argilés, Josep M; Betancourt, Angelica; Guàrdia-Olmos, Joan; Peró-Cebollero, Maribel; López-Soriano, Francisco J; Madeddu, Clelia; Serpe, Roberto; Busquets, Sílvia

2017-01-01

The CAchexia SCOre (CASCO) was described as a tool for the staging of cachectic cancer patients. The aim of this study is to show the metric properties of CASCO in order to classify cachectic cancer patients into three different groups, which are associated with a numerical scoring. The final aim was to clinically validate CASCO for its use in the classification of cachectic cancer patients in clinical practice. We carried out a case -control study that enrolled prospectively 186 cancer patients and 95 age-matched controls. The score includes five components: (1) body weight loss and composition, (2) inflammation/metabolic disturbances/immunosuppression, (3) physical performance, (4) anorexia, and (5) quality of life. The present study provides clinical validation for the use of the score. In order to show the metric properties of CASCO, three different groups of cachectic cancer patients were established according to the results obtained with the statistical approach used: mild cachexia (15 ≤ × ≤ 28), moderate cachexia (29 ≤ × ≤ 46), and severe cachexia (47 ≤ × ≤ 100). In addition, a simplified version of CASCO, MiniCASCO (MCASCO), was also presented and it contributes as a valid and easy-to-use tool for cachexia staging. Significant statistically correlations were found between CASCO and other validated indexes such as Eastern Cooperative Oncology Group (ECOG) and the subjective diagnosis of cachexia by specialized oncologists. A very significant estimated correlation between CASCO and MCASCO was found that suggests that MCASCO might constitute an easy and valid tool for the staging of the cachectic cancer patients. CASCO and MCASCO provide a new tool for the quantitative staging of cachectic cancer patients with a clear advantage over previous classifications.

Multi-scale analysis of neural activity in humans: Implications for micro-scale electrocorticography.

PubMed

Kellis, Spencer; Sorensen, Larry; Darvas, Felix; Sayres, Conor; O'Neill, Kevin; Brown, Richard B; House, Paul; Ojemann, Jeff; Greger, Bradley

2016-01-01

Electrocorticography grids have been used to study and diagnose neural pathophysiology for over 50 years, and recently have been used for various neural prosthetic applications. Here we provide evidence that micro-scale electrodes are better suited for studying cortical pathology and function, and for implementing neural prostheses. This work compares dynamics in space, time, and frequency of cortical field potentials recorded by three types of electrodes: electrocorticographic (ECoG) electrodes, non-penetrating micro-ECoG (μECoG) electrodes that use microelectrodes and have tighter interelectrode spacing; and penetrating microelectrodes (MEA) that penetrate the cortex to record single- or multiunit activity (SUA or MUA) and local field potentials (LFP). While the finest spatial scales are found in LFPs recorded intracortically, we found that LFP recorded from μECoG electrodes demonstrate scales of linear similarity (i.e., correlation, coherence, and phase) closer to the intracortical electrodes than the clinical ECoG electrodes. We conclude that LFPs can be recorded intracortically and epicortically at finer scales than clinical ECoG electrodes are capable of capturing. Recorded with appropriately scaled electrodes and grids, field potentials expose a more detailed representation of cortical network activity, enabling advanced analyses of cortical pathology and demanding applications such as brain-computer interfaces. Copyright © 2015 International Federation of Clinical Neurophysiology. Published by Elsevier Ireland Ltd. All rights reserved.

Non-invasive monitoring of spreading depression.

PubMed

Bastany, Zoya J R; Askari, Shahbaz; Dumont, Guy A; Speckmann, Erwin-Josef; Gorji, Ali

2016-10-01

Spreading depression (SD), a slow propagating depolarization wave, plays an important role in pathophysiology of different neurological disorders. Yet, research into SD-related disorders has been hampered by the lack of non-invasive recording techniques of SD. Here we compared the manifestations of SD in continuous non-invasive electroencephalogram (EEG) recordings to invasive electrocorticographic (ECoG) recordings in order to obtain further insights into generator structures and electrogenic mechanisms of surface recording of SD. SD was induced by KCl application and simultaneous SD recordings were performed by scalp EEG as well as ECoG electrodes of somatosensory neocortex of rats using a novel homemade EEG amplifier, AgCl recording electrodes, and high chloride conductive gel. Different methods were used to analyze the data; including the spectrogram, bi-spectrogram, pattern distribution, relative spectrum power, and multivariable Gaussian fit analysis. The negative direct current (DC) shifts recorded by scalp electrodes exhibited a high homogeneity to those recorded by ECoG electrodes. Furthermore, this novel method of recording and analysis was able to separate SD recorded by scalp electrodes from non-neuronal DC shifts induced by other potential generators, such as the skin, muscles, arteries, dura, etc. These data suggest a novel application for continuous non-invasive monitoring of DC potential changes, such as SD. Non-invasive monitoring of SD would allow early intervention and improve outcome in SD-related neurological disorders. Copyright © 2016 IBRO. All rights reserved.

Gamma-oscillations modulated by picture naming and word reading: Intracranial recording in epileptic patients

PubMed Central

Wu, Helen C.; Nagasawa, Tetsuro; Brown, Erik C.; Juhasz, Csaba; Rothermel, Robert; Hoechstetter, Karsten; Shah, Aashit; Mittal, Sandeep; Fuerst, Darren; Sood, Sandeep; Asano, Eishi

2011-01-01

Objective We measured cortical gamma-oscillations in response to visual-language tasks consisting of picture naming and word reading in an effort to better understand human visual-language pathways. Methods We studied six patients with focal epilepsy who underwent extraoperative electrocorticography (ECoG) recording. Patients were asked to overtly name images presented sequentially in the picture naming task and to overtly read written words in the reading task. Results Both tasks commonly elicited gamma-augmentation (maximally at 80–100 Hz) on ECoG in the occipital, inferior-occipital-temporal and inferior-Rolandic areas, bilaterally. Picture naming, compared to reading task, elicited greater gamma-augmentation in portions of pre-motor areas as well as occipital and inferior-occipital-temporal areas, bilaterally. In contrast, word reading elicited greater gamma-augmentation in portions of bilateral occipital, left occipital-temporal and left superior-posterior-parietal areas. Gamma-attenuation was elicited by both tasks in portions of posterior cingulate and ventral premotor-prefrontal areas bilaterally. The number of letters in a presented word was positively correlated to the degree of gamma-augmentation in the medial occipital areas. Conclusions Gamma-augmentation measured on ECoG identified cortical areas commonly and differentially involved in picture naming and reading tasks. Longer words may activate the primary visual cortex for the more peripheral field. Significance The present study increases our understanding of the visual-language pathways. PMID:21498109

Changes in glutamate concentration, glucose metabolism, and cerebral blood flow during focal brain cooling of the epileptogenic cortex in humans.

PubMed

Nomura, Sadahiro; Fujii, Masami; Inoue, Takao; He, Yeting; Maruta, Yuichi; Koizumi, Hiroyasu; Suehiro, Eiichi; Imoto, Hirochika; Ishihara, Hideyuki; Oka, Fumiaki; Matsumoto, Mishiya; Owada, Yuji; Yamakawa, Takeshi; Suzuki, Michiyasu

2014-05-01

Recently, focal brain cooling (FBC) was proposed as a method for treating refractory epilepsy. However, the precise influence of cooling on the molecular basis of epilepsy has not been elucidated. Thus the aim of this study was to assess the effect of FBC on glutamate (Glu) concentration, cerebral blood flow (CBF), and glucose metabolism in patients with intractable epilepsy. Nine patients underwent FBC at 15°C for 30 min prior to cortical resection (n = 6) or hippocampectomy (n = 3). Measurement of metabolites and CBF, as well as electrocorticography (ECoG), was performed. Epileptic discharge (ED), as observed by ECoG, disappeared in the cooling period and reappeared in the rewarming period. Glu concentrations were high during the precooling period and were reduced to 51.2% during the cooling period (p = 0.025). Glycerol levels showed a similar decrease (p = 0.028). Lactate concentration was high during the precooling period and was reduced during the cooling period (21.3% decrease; p = 0.005). Glucose and pyruvate levels were maintained throughout the procedure. Changes in CBF were parallel to those observed by ECoG. FBC reduced EDs and concentrations of Glu and glycerol. This demonstrates the neuroprotective effect of FBC. Our findings confirm that FBC is a reasonable and optimal treatment option for patients with intractable epilepsy. Wiley Periodicals, Inc. © 2014 International League Against Epilepsy.

Minimal clinically important improvement (MCII) and patient-acceptable symptom state (PASS) in total hip arthroplasty (THA) patients 1 year postoperatively

PubMed Central

Paulsen, Aksel

2014-01-01

Background and purpose The increased use of patient-reported outcomes (PROs) in orthopedics requires data on estimated minimal clinically important improvements (MCIIs) and patient-acceptable symptom states (PASSs). We wanted to find cut-points corresponding to minimal clinically important PRO change score and the acceptable postoperative PRO score, by estimating MCII and PASS 1 year after total hip arthroplasty (THA) for the Hip Dysfunction and Osteoarthritis Outcome Score (HOOS) and the EQ-5D. Patients and methods THA patients from 16 different departments received 2 PROs and additional questions preoperatively and 1 year postoperatively. The PROs included were the HOOS subscales pain (HOOS Pain), physical function short form (HOOS-PS), and hip-related quality of life (HOOS QoL), and the EQ-5D. MCII and PASS were estimated using multiple anchor-based approaches. Results Of 1,837 patients available, 1,335 answered the preoperative PROs, and 1,288 of them answered the 1-year follow-up. The MCIIs and PASSs were estimated to be: 24 and 91 (HOOS Pain), 23 and 88 (HOOS-PS), 17 and 83 (HOOS QoL), 0.31 and 0.92 (EQ-5D Index), and 23 and 85 (EQ-VAS), respectively. MCIIs corresponded to a 38–55% improvement from mean baseline PRO score and PASSs corresponded to absolute follow-up scores of 57–91% of the maximum score in THA patients 1 year after surgery. Interpretation This study improves the interpretability of PRO scores. The different estimation approaches presented may serve as a guide for future MCII and PASS estimations in other contexts. The cutoff points may serve as reference values in registry settings. PMID:24286564

A new prognostic model for chemotherapy-induced febrile neutropenia.

PubMed

Ahn, Shin; Lee, Yoon-Seon; Lee, Jae-Lyun; Lim, Kyung Soo; Yoon, Sung-Cheol

2016-02-01

The objective of this study was to develop and validate a new prognostic model for febrile neutropenia (FN). This study comprised 1001 episodes of FN: 718 for the derivation set and 283 for the validation set. Multivariate logistic regression analysis was performed with unfavorable outcome as the primary endpoint and bacteremia as the secondary endpoint. In the derivation set, risk factors for adverse outcomes comprised age ≥ 60 years (2 points), procalcitonin ≥ 0.5 ng/mL (5 points), ECOG performance score ≥ 2 (2 points), oral mucositis grade ≥ 3 (3 points), systolic blood pressure <90 mmHg (3 points), and respiratory rate ≥ 24 breaths/min (3 points). The model stratified patients into three severity classes, with adverse event rates of 6.0 % in class I (score ≤ 2), 27.3 % in class II (score 3-8), and 67.9 % in class III (score ≥ 9). Bacteremia was present in 1.1, 11.5, and 29.8 % of patients in class I, II, and III, respectively. The outcomes of the validation set were similar in each risk class. When the derivation and validation sets were integrated, unfavorable outcomes occurred in 5.9 % of the low-risk group classified by the new prognostic model and in 12.2 % classified by the Multinational Association for Supportive Care in Cancer (MASCC) risk index. With the new prognostic model, we can classify patients with FN into three classes of increasing adverse outcomes and bacteremia. Early discharge would be possible for class I patients, short-term observation could safely manage class II patients, and inpatient admission is warranted for class III patients.

The electrophysiological "delayed effect" of focal interictal epileptiform discharges. A low resolution electromagnetic tomography (LORETA) study.

PubMed

Clemens, Béla; Piros, Pálma; Bessenyei, Mónika; Varga, Edit; Puskás, Szilvia; Fekete, István

2009-08-01

Collating the findings regarding the role of focal interictal epileptiform discharges (IEDs) on CNS functions raises the possibility that IEDs might have negative impact that outlasts the duration of the spike-and-wave complexes. The aim of this study was the electrophysiological demonstration of the "delayed effect" of the IEDs. 19-channel, linked-ears referenced, digital waking EEG records of 11 children (aged 6-14 years, eight with idiopathic, three with cryptogenic focal epilepsy, showing a single spike focus) were retrospectively selected from our database. A minimum of 20 (preferably, 30), 2-s epochs containing a single focal spike-and-wave complex were selected (Spike epochs). Thereafter, Postspike-1 (Ps1), Postspike-2 (Ps2) and Postspike-3 (Ps3) epochs were selected, representing the first and second seconds (Ps1), the third and fourth seconds (Ps2) and the fifth and sixth seconds (Ps3) after the Spike epoch, respectively. Interspike epochs (Is) were selected at a distance at least 10s after the Spike epoch. Individual analysis: the frequency of interest (FOI=the individual frequency of the wave component of the IEDs), and the region of interest (ROI=the site of the IEDs) were identified by reading the raw EEG waveform and the instant power spectrum. Very narrow band LORETA (low resolution electromagnetic tomography) analysis at the FOI and ROI was carried out. Age-adjusted, Z-transformed LORETA "activity" (=current source density, amperes/meters squared) was compared in the Spike, Ps1, Ps2, Ps3 and Is epochs. the greatest (uppermost pathological) Z-scores and the greatest spatial extension of the LORETA-abnormality were always found in the Spike epochs, followed by the gradual decrease of activity in terms of severity and spatial extension in the Ps1, Ps2, Ps3 epochs. The lowest (baseline) level and extension of the abnormality was found in the Is epochs. Group analysis: average values of activity across the patients were computed for the temporal decrease of the abnormality. a clear tendency for the decrease of abnormality was demonstrated. the "delayed effect" of the IEDs was demonstrated electrophysiologically and quantified. The method may be utilized in the individual assessment of the effect of IEDs on cortical activity, the degree and temporo-spatial extension of the abnormality.

Impact of use of angiotensin II receptor blocker on all-cause mortality in hemodialysis patients: prospective cohort study using a propensity-score analysis.

PubMed

Tanaka, Marenao; Yamashita, Tomohisa; Koyama, Masayuki; Moniwa, Norihito; Ohno, Kohei; Mitsumata, Kaneto; Itoh, Takahito; Furuhashi, Masato; Ohnishi, Hirofumi; Yoshida, Hideaki; Tsuchihashi, Kazufumi; Miura, Tetsuji

2016-06-01

It is controversial whether treatment with an angiotensin II receptor blocker (ARB) or a calcium channel blocker (CCB) improves prognosis of hemodialysis (HD) patients. This study was designed as a multicenter prospective cohort study. HD patients (n = 1071) were enrolled from 22 institutes in January 2009 and followed up for 3 years. Patients with missing data, kidney transplantation or retraction of consent during the follow-up period (n = 204) were excluded, and 867 patients contributed to analysis of mortality. Propensity score (PS) for use of ARB and that for CCB was calculated using a multiple logistic regression model. ARB and CCB were prescribed in 45.6 and 54.7 % of patients at enrollment. During the 3-year follow-up period, all-cause mortality and cardiovascular mortality rates were 18.8 and 5.1 %, respectively. Kaplan-Meier curves showed that all-cause and cardiovascular mortality rates were lower in the ARB group than in the non-ARB group, though the mortality rates were similar in the CCB group and non-CCB group. In PS-stratified Cox regression analysis, ARB treatment was associated with 34 and 45 % reduction of all-cause death and cardiovascular death, respectively. In PS matching analysis, ARB treatment was associated with a significant reduction (46 % reduction) in the risk of all-cause death. A significant impact of CCB treatment on all-cause or cardiovascular mortality was not detected in PS analysis. The use of an ARB, but not a CCB, is associated with reduced all-cause and cardiovascular mortalities in patients on HD.

Dimensions of Deaf/Hard-of-Hearing and Hearing Adolescents' Health Literacy and Health Knowledge.

PubMed

Smith, Scott R; Samar, Vincent J

2016-01-01

Deaf and hard-of-hearing (D/HH) adults have lower health literacy compared to hearing adults, but it is unclear whether this disparity also occurs in adolescence. We used the Health Literacy Skills Instrument-Short Form (HLSI-SF), Short Form of the Test of Functional Health Literacy in Adults (S-TOFHLA), Comprehensive Heart Disease Knowledge Questionnaire (CHDKQ), and newly constructed interactive and critical health literacy survey items to quantify D/HH and hearing adolescents' health literacy. We adapted and translated survey materials into sign language and spoken English to reduce testing bias due to variable English language skills. Participants were 187 D/HH and 94 hearing college-bound high school students. When we adjusted for age, gender, race/ethnicity, school grade, and socioeconomic status, D/HH adolescents demonstrated weaker general and functional health literacy and cardiovascular health knowledge than hearing adolescents on the HLSI, S-TOFHLA, and CHDKQ (all ps < .0001). Standard health literacy or knowledge scores were associated with several interactive and critical health literacy skills (all ps < .05). D/HH adolescents who reported greater hearing-culture identity, having hearing aids, experiencing better hearing with assistive devices, having good quality of communication with parents, and attending hearing schools at least half of the time had higher functional health literacy (all ps < .025). Those who reported English as their best language and attending hearing schools at least half of the time had higher cardiovascular health knowledge scores (all ps < .03). Results suggest that interventions to improve D/HH adolescents' health literacy should target their health-related conversations with their families; access to printed health information; and access to health information from other people, especially health care providers and educators.

Sport-Specific Training Targeting the Proximal Segments and Throwing Velocity in Collegiate Throwing Athletes

PubMed Central

Palmer, Thomas; Uhl, Timothy L.; Howell, Dana; Hewett, Timothy E.; Viele, Kert; Mattacola, Carl G.

2015-01-01

Context The ability to generate, absorb, and transmit forces through the proximal segments of the pelvis, spine, and trunk has been proposed to influence sport performance, yet traditional training techniques targeting the proximal segments have had limited success improving sport-specific performance. Objective To investigate the effects of a traditional endurance-training program and a sport-specific power-training program targeting the muscles that support the proximal segments and throwing velocity. Design Randomized controlled clinical trial. Setting University research laboratory and gymnasium. Patients or Other Participants A total of 46 (age = 20 ± 1.3 years, height = 175.7 ± 8.7 cm) healthy National Collegiate Athletic Association Division III female softball (n = 17) and male baseball (n = 29) players. Intervention(s) Blocked stratification for sex and position was used to randomly assign participants to 1 of 2 training groups for 7 weeks: a traditional endurance-training group (ET group; n = 21) or a power-stability–training group (PS group; n = 25). Mean Outcome Measure(s) The change score in peak throwing velocity (km/h) normalized for body weight (BW; kilograms) and change score in tests that challenge the muscles of the proximal segments normalized for BW (kilograms). We used 2-tailed independent-samples t tests to compare differences between the change scores. Results The peak throwing velocity (ET group = 0.01 ± 0.1 km/h/kg of BW, PS group = 0.08 ± 0.03 km/h/kg of BW; P < .001) and muscle power outputs for the chop (ET group = 0.22 ± 0.91 W/kg of BW, PS group = 1.3 ± 0.91 W/kg of BW; P < .001) and lift (ET group = 0.59 ± 0.67 W/kg of BW, PS group = 1.4 ± 0.87 W/kg of BW; P < .001) tests were higher at postintervention in the PT than in the ET group. Conclusions An improvement in throwing velocity occurred simultaneously with measures of muscular endurance and power after a sport-specific training regimen targeting the proximal segments. PMID:25844854

Recording Human Electrocorticographic (ECoG) Signals for Neuroscientific Research and Real-time Functional Cortical Mapping

PubMed Central

Hill, N. Jeremy; Gupta, Disha; Brunner, Peter; Gunduz, Aysegul; Adamo, Matthew A.; Ritaccio, Anthony; Schalk, Gerwin

2012-01-01

Neuroimaging studies of human cognitive, sensory, and motor processes are usually based on noninvasive techniques such as electroencephalography (EEG), magnetoencephalography or functional magnetic-resonance imaging. These techniques have either inherently low temporal or low spatial resolution, and suffer from low signal-to-noise ratio and/or poor high-frequency sensitivity. Thus, they are suboptimal for exploring the short-lived spatio-temporal dynamics of many of the underlying brain processes. In contrast, the invasive technique of electrocorticography (ECoG) provides brain signals that have an exceptionally high signal-to-noise ratio, less susceptibility to artifacts than EEG, and a high spatial and temporal resolution (i.e., <1 cm/<1 millisecond, respectively). ECoG involves measurement of electrical brain signals using electrodes that are implanted subdurally on the surface of the brain. Recent studies have shown that ECoG amplitudes in certain frequency bands carry substantial information about task-related activity, such as motor execution and planning1, auditory processing2 and visual-spatial attention3. Most of this information is captured in the high gamma range (around 70-110 Hz). Thus, gamma activity has been proposed as a robust and general indicator of local cortical function1-5. ECoG can also reveal functional connectivity and resolve finer task-related spatial-temporal dynamics, thereby advancing our understanding of large-scale cortical processes. It has especially proven useful for advancing brain-computer interfacing (BCI) technology for decoding a user's intentions to enhance or improve communication6 and control7. Nevertheless, human ECoG data are often hard to obtain because of the risks and limitations of the invasive procedures involved, and the need to record within the constraints of clinical settings. Still, clinical monitoring to localize epileptic foci offers a unique and valuable opportunity to collect human ECoG data. We describe our methods for collecting recording ECoG, and demonstrate how to use these signals for important real-time applications such as clinical mapping and brain-computer interfacing. Our example uses the BCI2000 software platform8,9 and the SIGFRIED10 method, an application for real-time mapping of brain functions. This procedure yields information that clinicians can subsequently use to guide the complex and laborious process of functional mapping by electrical stimulation. Prerequisites and Planning: Patients with drug-resistant partial epilepsy may be candidates for resective surgery of an epileptic focus to minimize the frequency of seizures. Prior to resection, the patients undergo monitoring using subdural electrodes for two purposes: first, to localize the epileptic focus, and second, to identify nearby critical brain areas (i.e., eloquent cortex) where resection could result in long-term functional deficits. To implant electrodes, a craniotomy is performed to open the skull. Then, electrode grids and/or strips are placed on the cortex, usually beneath the dura. A typical grid has a set of 8 x 8 platinum-iridium electrodes of 4 mm diameter (2.3 mm exposed surface) embedded in silicon with an inter-electrode distance of 1cm. A strip typically contains 4 or 6 such electrodes in a single line. The locations for these grids/strips are planned by a team of neurologists and neurosurgeons, and are based on previous EEG monitoring, on a structural MRI of the patient's brain, and on relevant factors of the patient's history. Continuous recording over a period of 5-12 days serves to localize epileptic foci, and electrical stimulation via the implanted electrodes allows clinicians to map eloquent cortex. At the end of the monitoring period, explantation of the electrodes and therapeutic resection are performed together in one procedure. In addition to its primary clinical purpose, invasive monitoring also provides a unique opportunity to acquire human ECoG data for neuroscientific research. The decision to include a prospective patient in the research is based on the planned location of their electrodes, on the patient's performance scores on neuropsychological assessments, and on their informed consent, which is predicated on their understanding that participation in research is optional and is not related to their treatment. As with all research involving human subjects, the research protocol must be approved by the hospital's institutional review board. The decision to perform individual experimental tasks is made day-by-day, and is contingent on the patient's endurance and willingness to participate. Some or all of the experiments may be prevented by problems with the clinical state of the patient, such as post-operative facial swelling, temporary aphasia, frequent seizures, post-ictal fatigue and confusion, and more general pain or discomfort. At the Epilepsy Monitoring Unit at Albany Medical Center in Albany, New York, clinical monitoring is implemented around the clock using a 192-channel Nihon-Kohden Neurofax monitoring system. Research recordings are made in collaboration with the Wadsworth Center of the New York State Department of Health in Albany. Signals from the ECoG electrodes are fed simultaneously to the research and the clinical systems via splitter connectors. To ensure that the clinical and research systems do not interfere with each other, the two systems typically use separate grounds. In fact, an epidural strip of electrodes is sometimes implanted to provide a ground for the clinical system. Whether research or clinical recording system, the grounding electrode is chosen to be distant from the predicted epileptic focus and from cortical areas of interest for the research. Our research system consists of eight synchronized 16-channel g.USBamp amplifier/digitizer units (g.tec, Graz, Austria). These were chosen because they are safety-rated and FDA-approved for invasive recordings, they have a very low noise-floor in the high-frequency range in which the signals of interest are found, and they come with an SDK that allows them to be integrated with custom-written research software. In order to capture the high-gamma signal accurately, we acquire signals at 1200Hz sampling rate-considerably higher than that of the typical EEG experiment or that of many clinical monitoring systems. A built-in low-pass filter automatically prevents aliasing of signals higher than the digitizer can capture. The patient's eye gaze is tracked using a monitor with a built-in Tobii T-60 eye-tracking system (Tobii Tech., Stockholm, Sweden). Additional accessories such as joystick, bluetooth Wiimote (Nintendo Co.), data-glove (5th Dimension Technologies), keyboard, microphone, headphones, or video camera are connected depending on the requirements of the particular experiment. Data collection, stimulus presentation, synchronization with the different input/output accessories, and real-time analysis and visualization are accomplished using our BCI2000 software8,9. BCI2000 is a freely available general-purpose software system for real-time biosignal data acquisition, processing and feedback. It includes an array of pre-built modules that can be flexibly configured for many different purposes, and that can be extended by researchers' own code in C++, MATLAB or Python. BCI2000 consists of four modules that communicate with each other via a network-capable protocol: a Source module that handles the acquisition of brain signals from one of 19 different hardware systems from different manufacturers; a Signal Processing module that extracts relevant ECoG features and translates them into output signals; an Application module that delivers stimuli and feedback to the subject; and the Operator module that provides a graphical interface to the investigator. A number of different experiments may be conducted with any given patient. The priority of experiments will be determined by the location of the particular patient's electrodes. However, we usually begin our experimentation using the SIGFRIED (SIGnal modeling For Realtime Identification and Event Detection) mapping method, which detects and displays significant task-related activity in real time. The resulting functional map allows us to further tailor subsequent experimental protocols and may also prove as a useful starting point for traditional mapping by electrocortical stimulation (ECS). Although ECS mapping remains the gold standard for predicting the clinical outcome of resection, the process of ECS mapping is time consuming and also has other problems, such as after-discharges or seizures. Thus, a passive functional mapping technique may prove valuable in providing an initial estimate of the locus of eloquent cortex, which may then be confirmed and refined by ECS. The results from our passive SIGFRIED mapping technique have been shown to exhibit substantial concurrence with the results derived using ECS mapping10. The protocol described in this paper establishes a general methodology for gathering human ECoG data, before proceeding to illustrate how experiments can be initiated using the BCI2000 software platform. Finally, as a specific example, we describe how to perform passive functional mapping using the BCI2000-based SIGFRIED system. PMID:22782131

The validity of the Menopause-specific Quality of Life questionnaire in women with type 2 diabetes.

PubMed

Hasan, S S; Ahmadi, K; Santigo, R; Ahmed, S I

2014-08-01

To examine the validity and reliability of the Menopause-specific Quality of Life (MENQOL) questionnaire in a sample of women with diabetes in Malaysia, with the secondary aim of determining whether MENQOL domain scores were associated with depression and diabetes. A total of 337 postmenopausal women (241 with diabetes, 96 controls) were evaluated. Construct validity was evaluated using principal components analysis (PCA) and comparing scale items against the mental component score of the Short Form-12 (SF-12 MCS), and against the Center for Epidemiologic Studies Depression Scale 10 (CES-D 10). Consistency assessment was conducted using Cronbach's α. The internal consistencies for the physical (PHS), psychosocial (PS), sexual (VSS) and vasomotor domains were 0.86, 0.79, 0.79 and 0.70, and 0.90 for the full scale of MENQOL. PCA revealed a four-factorial model. Diabetes and non-diabetes subjects experienced their first period (13.25 vs. 13.10 years, p = 0.680) and achieved menopause around the same age (49.35 vs. 48.87 years, p = 0.426). We found significant variations in the MENQOL's PHS and PS domain scores that could be explained by SF-12 PCS (25%) and SF-12 MCS (20%) sub-scales. The validity of the MENQOL domains was demonstrated through significant associations with the equivalent SF-12 MCS and PCS subscales. The PS domain of the MENQOL also predicted the likelihood of symptoms of depression (1.42, 95% confidence interval 1.01-2.02). This study confirms the validity and internal consistency of the MENQOL questionnaire for measuring quality of life in postmenopausal women with diabetes, suggesting that the instrument can be used to screen people for menopausal symptoms.

Quality of Life and Psychological State in Chinese Breast Cancer Patients Who Received BRCA1/2 Genetic Testing

PubMed Central

Qiu, Jiajia; Guan, Jiaqin; Yang, Xiaochen; Wu, Jiong; Liu, Guangyu; Di, Genhong; Chen, Canming; Hou, Yifeng; Han, Qixia; Shen, Zhenzhou; Shao, Zhimin; Hu, Zhen

2016-01-01

Background This study aims to understand the quality of life (QOL) and psychological state (PS) of Chinese breast cancer patients who received BRCA1/2 genetic testing; to examine the psychological changes between BRCA1/2 mutation carriers and non-carriers; and to further explore the psychological experience of BRCA1/2 mutation carriers. Methods This study was combined with quantitative and qualitative designs. First, we performed a quantitative investigation using FACT-B (Chinese version) and Irritability, Depression and Anxiety scale (IDA) to assess the QOL and PS in breast cancer patients who received BRCA1/2 genetic testing. Then semi-structured in-depth qualitative interviews among 13 mutation carriers were conducted in hospital. Results Results from the quantitative study showed QOL scores were relatively high and the IDA scores were relatively low among the patients, and there was no significant difference in the QOL or IDA scores between non-carriers and carriers. Based on the qualitative analysis, four main themes emerged: (1) Finding the reason for having breast cancer; (2) Negative emotions; (3) Behavioral changes; (4) Lack of information. Conclusions The present study showed that QOL and PS are good among the breast cancer patients who received genetic testing. Genetic testing itself does not cause long psychosocial effects. BRCA1/2 mutation carriers may have certain negative emotions at the first stage they knew the testing results and may initiate behavioral and lifestyle changes. The patients with a BRCA1/2 mutation desire knowledge with regard to genetic aspects in mainland China. Professional information and advice can be provided to relieve the patients’ negative emotions when they were informed of gene defect. PMID:27428375

Psychosocial profiles of people with pain associated with spinal cord injury: identification and comparison with other chronic pain syndromes.

PubMed

Widerström-Noga, Eva G; Duncan, Robert; Turk, Dennis C

2004-01-01

The objectives of the study were to: (1) identify psychosocial profiles of people with pain associated with spinal cord injuries (SCI), and (2) compare the psychosocial profiles with other chronic pain syndromes. History questionnaires and the Multidimensional Pain Inventory (MPI) were mailed to 159 persons with chronic pain and SCIs (SCICP) and 120 (75.5%) agreed to participate. Cluster analysis of MPI scores identified 2 subgroups of SCICP. One (42.5%) was characterized by high Pain Severity (PS), Affective Distress (AD), Life Interference (LI), and low Life Control (LC) similar to a previously identified cluster labeled Dysfunctional. The second (57.5%) was characterized by low PS, AD, LI, and high levels of LC and activity (GA), similar to the Adaptive Copers (AC) cluster identified in previous studies with the exception that the scores were lower on Support (S), Solicitous Responses (SR), and Negative Responses (NR) and higher on Distracting Responses (DR). Both subgroups were similar to those observed in other chronic pain syndromes (CPSs). People with SCIs differed significantly from heterogeneous chronic pain and chronic headaches in that they indicated less inference of pain with activities. They also scored lower on S. SCICP reported comparable levels of LI, LC, AD, S, SR, but greater levels of PS compared with a group of people with post-polio syndrome. The similarities and differences between SCI and other CPSs suggest that although a general measure assessing psychosocial impact can be used across pain syndromes, it is important to use different norms for comparison of particular pain syndromes. The failure to identify a subgroup of patients characterized by low levels of S and high levels of NR, and the low SR and DR for SCICP compared with other CPSs warrants examination.

Sex determines which section of the SLC6A4 gene is linked to obsessive-compulsive symptoms in normal Chinese college students.

PubMed

Lei, Xuemei; Chen, Chuansheng; He, Qinghua; Chen, Chunhui; Moyzis, Robert K; Xue, Gui; Chen, Xiongying; Cao, Zhongyu; Li, Jin; Li, He; Zhu, Bi; Chun Hsu, Anna Shan; Li, Sufang; Li, Jun; Dong, Qi

2012-09-01

Previous case-control and family-based association studies have implicated the SLC6A4 gene in obsessive-compulsive disorder (OCD). Little research, however, has examined this gene's role in obsessive-compulsive symptoms (OCS) in community samples. The present study genotyped seven tag SNPs and two common functional tandem repeat polymorphisms (5-HTTLPR and STin2), which together cover the whole SLC6A4 gene, and investigated their associations with OCS in normal Chinese college students (N = 572). The results revealed a significant gender main effect and gender-specific genetic effects of the SLC6A4 gene on OCS. Males scored significantly higher on total OCS and its three dimensions than did females (ps < .01). The 5-HTTLPR in the promoter region showed a female-specific genetic effect, with the l/l and l/s genotypes linked to higher OCS scores than the s/s genotype (ps < .05). In contrast, a conserved haplotype polymorphism (rs1042173| rs4325622| rs3794808| rs140701| rs4583306| rs2020942) covering from intron 3 to the 3' UTR of the SLC6A4 gene showed male-specific genetic effects, with the CGAAGG/CGAAGG genotype associated with lower OCS scores than the other genotypes (ps < .05). These effects remained significant after controlling for OCS-related factors including participants' depressive and anxiety symptoms as well as stressful life events, and correction for multiple tests. These results are discussed in terms of their implications for our understanding of the sex-specific role of the different sections of the SLC6A4 gene in OCD. Published by Elsevier Ltd.

A real-time assessment of work stress in physicians and nurses.

PubMed

Rutledge, Thomas; Stucky, Erin; Dollarhide, Adrian; Shively, Martha; Jain, Sonia; Wolfson, Tanya; Weinger, Matthew B; Dresselhaus, Timothy

2009-03-01

This study adapted ecological momentary assessment methods to: (a) examine differences in work stress between nurses and physicians, and (b) to study relationships between work stress, work activity patterns, and sleep. A total of 185 physicians and 119 nurses (206 women, 98 men) working in four teaching hospitals participated in an observational study of work stress. Participants carried handheld computers that randomly prompted them for work activity, patient load, and work stress information. Participants completed more than 9,500 random interval surveys during the study (an average of 30.8 surveys per person-week). Approximately 85% of all surveys were completed in full (73.3%) or partially (11.6%). Emotional stress scores among physicians were nearly 50% higher (26.9[19.0]) than those of nurses (18.1[14.9], r[302] = .37, p < .001). Direct and indirect care activities were associated with higher stress reports by both clinician groups (rs[159] = .14-.26, ps < .01). Sleep quality and quantity were predictors of work stress scores (ps < .05). Finally, higher work stress and lower sleep quality were also associated with poorer memory performance (r[302] = -.12, .17, ps < 05). The findings identify patterns of work stress in relationship to work activities, sleep habits, and provider differences that may be used to assist ongoing hospital work reform efforts. (c) 2009 APA, all rights reserved

Presurgical language localization with visual naming associated ECoG high- gamma modulation in pediatric drug-resistant epilepsy.

PubMed

Arya, Ravindra; Wilson, J Adam; Fujiwara, Hisako; Rozhkov, Leonid; Leach, James L; Byars, Anna W; Greiner, Hansel M; Vannest, Jennifer; Buroker, Jason; Milsap, Griffin; Ervin, Brian; Minai, Ali; Horn, Paul S; Holland, Katherine D; Mangano, Francesco T; Crone, Nathan E; Rose, Douglas F

2017-04-01

This prospective study compared presurgical language localization with visual naming-associated high-γ modulation (HGM) and conventional electrical cortical stimulation (ECS) in children with intracranial electrodes. Patients with drug-resistant epilepsy who were undergoing intracranial monitoring were included if able to name pictures. Electrocorticography (ECoG) signals were recorded during picture naming (overt and covert) and quiet baseline. For each electrode the likelihood of high-γ (70-116 Hz) power modulation during naming task relative to the baseline was estimated. Electrodes with significant HGM were plotted on a three-dimensional (3D) cortical surface model. Sensitivity, specificity, and accuracy were calculated compared to clinical ECS. Seventeen patients with mean age of 11.3 years (range 4-19) were included. In patients with left hemisphere electrodes (n = 10), HGM during overt naming showed high specificity (0.81, 95% confidence interval [CI] 0.78-0.85), and accuracy (0.71, 95% CI 0.66-0.75, p < 0.001), but modest sensitivity (0.47) when ECS interference with naming (aphasia or paraphasic errors) and/or oral motor function was regarded as the gold standard. Similar results were reproduced by comparing covert naming-associated HGM with ECS naming sites. With right hemisphere electrodes (n = 7), no ECS-naming deficits were seen without interference with oral-motor function. HGM mapping showed a high specificity (0.81, 95% CI 0.78-0.84), and accuracy (0.76, 95% CI 0.71-0.81, p = 0.006), but modest sensitivity (0.44) compared to ECS interference with oral-motor function. Naming-associated ECoG HGM was consistently observed over Broca's area (left posterior inferior-frontal gyrus), bilateral oral/facial motor cortex, and sometimes over the temporal pole. This study supports the use of ECoG HGM mapping in children in whom adverse events preclude ECS, or as a screening method to prioritize electrodes for ECS testing. Wiley Periodicals, Inc. © 2017 International League Against Epilepsy.

Survival after yttrium-90 resin microsphere radioembolization of hepatocellular carcinoma across Barcelona clinic liver cancer stages: a European evaluation.

PubMed

Sangro, Bruno; Carpanese, Livio; Cianni, Roberto; Golfieri, Rita; Gasparini, Daniele; Ezziddin, Samer; Paprottka, Philipp M; Fiore, Francesco; Van Buskirk, Mark; Bilbao, Jose Ignacio; Ettorre, Giuseppe Maria; Salvatori, Rita; Giampalma, Emanuela; Geatti, Onelio; Wilhelm, Kai; Hoffmann, Ralf Thorsten; Izzo, Francesco; Iñarrairaegui, Mercedes; Maini, Carlo Ludovico; Urigo, Carlo; Cappelli, Alberta; Vit, Alessandro; Ahmadzadehfar, Hojjat; Jakobs, Tobias Franz; Lastoria, Secondo

2011-09-02

A multicenter analysis was conducted to evaluate the main prognostic factors driving survival after radioembolization using yttrium-90-labeled resin microspheres in patients with hepatocellular carcinoma at eight European centers. In total, 325 patients received a median activity of 1.6 GBq between September 2003 and December 2009, predominantly as whole-liver (45.2%) or right-lobe (38.5%) infusions. Typically, patients were Child-Pugh class A (82.5%), had underlying cirrhosis (78.5%), and had good Eastern Cooperative Oncology Group (ECOG) performance status (ECOG 0-1; 87.7%), but many had multinodular disease (75.9%) invading both lobes (53.1%) and/or portal vein occlusion (13.5% branch; 9.8% main). Over half had advanced Barcelona Clinic Liver Cancer (BCLC) staging (BCLC C, 56.3%) and one-quarter had intermediate staging (BCLC B, 26.8%). The median overall survival was 12.8 months (95% confidence interval, 10.9-15.7), which varied significantly by disease stage (BCLC A, 24.4 months [95% CI, 18.6-38.1 months]; BCLC B, 16.9 months [95% CI, 12.8-22.8 months]; BCLC C, 10.0 months [95% CI, 7.7-10.9 months]). Consistent with this finding , survival varied significantly by ECOG status, hepatic function (Child-Pugh class, ascites, and baseline total bilirubin), tumor burden (number of nodules, alpha-fetoprotein), and presence of extrahepatic disease. When considered within the framework of BCLC staging, variables reflecting tumor burden and liver function provided additional prognostic information. The most significant independent prognostic factors for survival upon multivariate analysis were ECOG status, tumor burden (nodules >5), international normalized ratio >1.2, and extrahepatic disease. Common adverse events were: fatigue, nausea/vomiting, and abdominal pain. Grade 3 or higher increases in bilirubin were reported in 5.8% of patients. All-cause mortality was 0.6% and 6.8% at 30 and 90 days, respectively. This analysis provides robust evidence of the survival achieved with radioembolization, including those with advanced disease and few treatment options. Copyright © 2011 American Association for the Study of Liver Diseases.

Provisional versus elective two-stent strategy for unprotected true left main bifurcation lesions: Insights from a FAILS-2 sub-study.

PubMed

Kawamoto, Hiroyoshi; Chieffo, Alaide; D'Ascenzo, Fabrizio; Jabbour, Richard J; Naganuma, Toru; Cerrato, Enrico; Ugo, Fabrizio; Pavani, Marco; Varbella, Ferdinando; Boccuzzi, Giacomo; Pennone, Mauro; Garbo, Roberto; Conrotto, Federico; Biondi-Zoccai, Giuseppe; D'Amico, Maurizio; Moretti, Claudio; Escaned, Javier; Gaita, Fiorenzo; Nakamura, Sunao; Colombo, Antonio

2018-01-01

This study sought to investigate the optimal percutaneous coronary intervention (PCI) strategy for true unprotected left main coronary artery (ULMCA) bifurcations. The FAILS-2 was a retrospective multi-center study including patients with ULMCA disease treated with second-generation drug-eluting stents. Of these, we compared clinical outcomes of a provisional strategy (PS; n=216) versus an elective two-stent strategy (E2S; n=161) for true ULMCA bifurcations. The primary endpoint was the incidence of major adverse cardiac events (MACEs) at 3-years. We further performed propensity-score adjustment for clinical outcomes. There were no significant differences between the groups in terms of patient and lesion characteristics. 9.7% of patients in the PS group crossed over to a provisional two-stent strategy. MACEs were not significantly different between groups (MACE at 3-year; PS 28.1% vs. E2S 28.9%, adjusted p=0.99). The rates of target lesion revascularization (TLR) on the circumflex artery (LCX) were numerically high in the E2S group (LCX-TLR at 3-years; PS 11.8% vs. E2S 16.6%, adjusted p=0.51). E2S was associated with a comparable MACE rate to PS for true ULMCA bifurcations. The rates of LCX-TLR tended to be higher in the E2S group although there was no statistical significance. This study sought to compare the clinical outcomes of a provisional strategy (PS) with an elective two-stent strategy (E2S) for the treatment of true unprotected left main coronary artery bifurcations. 377 Patients (PS 216 vs. E2S 161 patients) were evaluated, and 9.7% in the PS group crossed over to a two-stent strategy. E2S was associated with a similar major adverse cardiac event rate at 3-years when compared to the PS strategy (PS 28.1% vs. E2S 28.9%, p=0.99). However, the left circumflex artery TLR rate at 3-year tended to be higher in the E2S group (PS 11.8% vs. E2S 16.6%, p=0.51). Copyright © 2017 Elsevier B.V. All rights reserved.

Myofascial trigger points, pain, disability, and sleep quality in individuals with mechanical neck pain.

PubMed

Muñoz-Muñoz, Sonsoles; Muñoz-García, María T; Alburquerque-Sendín, Francisco; Arroyo-Morales, Manuel; Fernández-de-las-Peñas, César

2012-10-01

The purpose of this study was to investigate the presence of active myofascial trigger points (MTrPs) in a greater number of muscles than previous studies and the relation between the presence of MTrPs, the intensity of pain, disability, and sleep quality in mechanical neck pain. Fifteen patients with mechanical neck pain (80% women) and 12 comparable controls participated. Myofascial trigger points were bilaterally explored in the upper trapezius, splenius capitis, semispinalis capitis, sternocleidomastoid, levator scapulae, and scalene muscles in a blinded design. Myofascial trigger points were considered active if the subject recognized the elicited referred pain as a familiar symptom. Myofascial trigger points were considered latent if the elicited referred pain was not recognized as a symptom. Pain was collected with a numerical pain rate scale (0-10); disability was assessed with Neck Disability Index; and sleep quality, with the Pittsburgh Sleep Quality Index. Patients exhibited a greater disability and worse sleep quality than controls (P < .001). The Pittsburgh Sleep Quality Index score was associated with the worst intensity of pain (r = 0.589; P = .021) and disability (r = 0.552; P = .033). Patients showed a greater (P = .002) number of active MTrPs (mean, 2 ± 2) and similar number (P = .505) of latent MTrPs (1.6 ± 1.4) than controls (latent MTrPs, 1.3 ± 1.4). No significant association between the number of latent or active MTrPs and pain, disability, or sleep quality was found. The referred pain elicited by active MTrPs in the neck and shoulder muscles contributed to symptoms in mechanical neck pain. Patients exhibited higher disability and worse sleep quality than controls. Sleep quality was associated with pain intensity and disability. No association between active MTrPs and the intensity of pain, disability, or sleep quality was found. Copyright © 2012 National University of Health Sciences. Published by Mosby, Inc. All rights reserved.

Graphical Models for Quasi-Experimental Designs

ERIC Educational Resources Information Center

Steiner, Peter M.; Kim, Yongnam; Hall, Courtney E.; Su, Dan

2017-01-01

Randomized controlled trials (RCTs) and quasi-experimental designs like regression discontinuity (RD) designs, instrumental variable (IV) designs, and matching and propensity score (PS) designs are frequently used for inferring causal effects. It is well known that the features of these designs facilitate the identification of a causal estimand…

Prognostic impact of serum CYFRA 21–1 in patients with advanced lung adenocarcinoma: a retrospective study

PubMed Central

2013-01-01

Background Serum CYFRA 21–1 is one of the most important serum markers in the diagnosis of non-small cell lung cancer (NSCLC), especially squamous-cell carcinoma. However, it remains unknown whether pretreatment serum CYFRA 21–1 values (PCV) may also have prognostic implications in patients with advanced lung adenocarcinoma. Methods We retrospectively reviewed the data of 284 patients (pts) who were diagnosed as having advanced lung adenocarcinoma and had received initial therapy. Results Of the study subjects, 121 pts (43%) had activating epidermal growth factor receptor (EGFR) mutations (Mt+), while the remaining 163 pts (57%) had wild-type EGFR (Mt-). Univariate analysis identified gender (male/ female), ECOG performance status (PS) (0-1/ ≥2), PCV (<2.2 ng/ml/ ≥2.2 ng/ml), EGFR mutation status (Mt+/ Mt-), pretreatment serum CEA values (<5.0 ng/ml/ ≥5.0 ng/ml), smoking history (yes/ no) and EGFR-TKI treatment (yes/ no) as prognostic factors (p = .008, p < .0001, p < .0001, p < .0001, p = .036, p = .0012, p < .0001 respectively). Cox's multivariate regression analysis identified PCV < 2.2ng/ml as the only factor significantly associated with prolonged survival (p < .0001, hazard ratio: 0.43, 95% CI 0.31-0.59), after adjustments for PS (p < .0001), EGFR mutation status (p = .0069), date of start of initial therapy (p = .07), gender (p = .75), serum CEA level (p = .63), smoking history (p = .39) and EGFR-TKI treatment (p = .20). Furthermore, pts with Mt+ and PCV of <2.2 ng/ml had a more favorable prognosis than those with Mt+ and PCV of ≥2.2 ng/ml (MST: 67.0 vs. 21.0 months, p < .0001), and patients with Mt- and PCV of <2.2 ng/ml had a more favorable prognosis than those with Mt- and PCV of ≥2.2 ng/ml (MST: 24.1 vs. 10.2 months, p < .0001). Conclusion PCV may be a potential independent prognostic factor in both Mt+ and Mt- patients with advanced lung adenocarcinoma. PMID:23879483

Establishment of a standard operating procedure for predicting the time of calving in cattle

PubMed Central

Sauter-Louis, Carola; Braunert, Anna; Lange, Dorothee; Weber, Frank; Zerbe, Holm

2011-01-01

Precise calving monitoring is essential for minimizing the effects of dystocia in cows and calves. We conducted two studies in healthy cows that compared seven clinical signs (broad pelvic ligaments relaxation, vaginal secretion, udder hyperplasia, udder edema, teat filling, tail relaxation, and vulva edema) alone and in combination in order to predict the time of parturition. The relaxation of the broad pelvic ligaments combined with teat filling gave the best values for predicting either calving or no calving within 12 h. For the proposed parturition score (PS), a threshold of 4 PS points was identified below which calving within the next 12 h could be ruled out with a probability of 99.3% in cows (95.5% in heifers). Above this threshold, intermitted calving monitoring every 3 h and a progesterone rapid blood test (PRBT) would be recommended. By combining the PS and PRBT (if PS ≥ 4), the prediction of calving within the next 12 h improved from 14.9% to 53.1%, and the probability of ruling out calving was 96.8%. The PRBT was compared to the results of an enzyme immunoassay (sensitivity, 90.2%; specificity, 74.9%). The standard operating procedure developed in this study that combines the PS and PRBT will enable veterinarians to rule out or predict calving within a 12 h period in cows with high accuracy under field conditions. PMID:21586878

Pectoralis-serratus interfascial plane block vs thoracic paravertebral block for unilateral radical mastectomy with axillary evacuation.

PubMed

Hetta, Diab Fuad; Rezk, Khalid Mohammed

2016-11-01

The aim of this study was to evaluate the analgesic efficacy and safety of pectoralis-serratus interfascial plane block in comparison with thoracic paravertebral block for postmastectomy pain. A prospective randomized controlled study. Tertiary center, university hospital. Sixty-four adult women, American Society of Anesthesiologists physical status classes I, II, and III, scheduled for unilateral modified radical mastectomy with axillary evacuation. Patients were randomized to receive either pectoralis-serratus interfascial plane block, PS group (n=32), or thoracic paravertebral block, PV group (n=32). Twenty-four-hour morphine consumption and the time to rescue analgesic were recorded. The pain intensity evaluated by visual analog scale (VAS) score at 0, 2, 4, 8, 16, and 24hours postoperatively was also recorded. The median (interquartile range) postoperative 24-hour morphine consumption was significantly increased in PS group in comparison to PV group (PS vs PV), 20 mg (16-23 mg) vs 12 mg (10-14 mg) (P<.001). The median postoperative time to first analgesic request was significantly shorter in PS group compared to PV group (PS, 6 hours [5-7 hours], vs PV, 11 hours [9-13 hours]) (P<.001). The intensity of pain was low in both groups in VAS 0, 2, and 4hours postoperatively. However, there was significant reduction in VAS in PV group compared to PS group at 8, 16, and 24hours postoperatively. Pectoralis-serratus interfascial plane block was safe and easy to perform and decreased intensity of postmastectomy pain, but it was inferior to thoracic paravertebral block. Copyright © 2016 Elsevier Inc. All rights reserved.

The association between short interpregnancy interval and preterm birth in Louisiana: a comparison of methods.

PubMed

Howard, Elizabeth J; Harville, Emily; Kissinger, Patricia; Xiong, Xu

2013-07-01

There is growing interest in the application of propensity scores (PS) in epidemiologic studies, especially within the field of reproductive epidemiology. This retrospective cohort study assesses the impact of a short interpregnancy interval (IPI) on preterm birth and compares the results of the conventional logistic regression analysis with analyses utilizing a PS. The study included 96,378 singleton infants from Louisiana birth certificate data (1995-2007). Five regression models designed for methods comparison are presented. Ten percent (10.17 %) of all births were preterm; 26.83 % of births were from a short IPI. The PS-adjusted model produced a more conservative estimate of the exposure variable compared to the conventional logistic regression method (β-coefficient: 0.21 vs. 0.43), as well as a smaller standard error (0.024 vs. 0.028), odds ratio and 95 % confidence intervals [1.15 (1.09, 1.20) vs. 1.23 (1.17, 1.30)]. The inclusion of more covariate and interaction terms in the PS did not change the estimates of the exposure variable. This analysis indicates that PS-adjusted regression may be appropriate for validation of conventional methods in a large dataset with a fairly common outcome. PS's may be beneficial in producing more precise estimates, especially for models with many confounders and effect modifiers and where conventional adjustment with logistic regression is unsatisfactory. Short intervals between pregnancies are associated with preterm birth in this population, according to either technique. Birth spacing is an issue that women have some control over. Educational interventions, including birth control, should be applied during prenatal visits and following delivery.

Impact of Disease Severity, Illness Beliefs, and Coping Strategies on Outcomes in Psoriatic Arthritis.

PubMed

Howells, Laura; Chisholm, Anna; Cotterill, Sarah; Chinoy, Hector; Warren, Richard B; Bundy, Christine

2018-02-01

Little is known about how people with psoriatic arthritis (PsA) cope with and manage their condition, but data show that psychological problems are underrecognized and undertreated. The Common Sense Self-Regulatory Model (CS-SRM) suggests illness beliefs, mediated by coping, may influence health outcomes. The study aimed to investigate the roles of disease severity, illness beliefs, and coping strategies in predicting depression, anxiety, and quality of life (QoL) in people with PsA. Additionally, we aimed to assess the role of depression and anxiety in predicting QoL. We conducted a cross-sectional observational study, where adults with PsA (n = 179) completed validated measures of predictor (illness beliefs, coping strategies, disease severity) and outcome variables (depression, anxiety, QoL) using an online survey distributed via social media. The participants were a community sample of 179 adults with PsA, ages 20 to 72 years (77.1% female). After controlling for disease severity, hierarchical multiple regression models indicated that more negative beliefs about consequences and behavioral disengagement as a coping method predicted levels of depression, and self-blame predicted anxiety. Beliefs about consequences and the presence of depression predicted quality of life scores after controlling for disease severity. This study offers support for the use of the CS-SRM in explaining variation on psychological outcomes in individuals with PsA. The illness beliefs and coping strategies identified as predictors in this article are potential targets for interventions addressing PsA-related distress and QoL. © 2017, American College of Rheumatology.

Long-term correlation of the electrocorticogram as a bioindicator of brain exposure to ionizing radiation.

PubMed

Aguiar, L A A; Silva, I M S; Fernandes, T S; Nogueira, R A

2015-10-01

Understanding the effects of radiation and its possible influence on the nervous system are of great clinical interest. However, there have been few electrophysiological studies on brain activity after exposure to ionizing radiation (IR). A new methodological approach regarding the assessment of the possible effects of IR on brain activity is the use of linear and nonlinear mathematical methods in the analysis of complex time series, such as brain oscillations measured using the electrocorticogram (ECoG). The objective of this study was to use linear and nonlinear mathematical methods as biomarkers of gamma radiation regarding cortical electrical activity. Adult Wistar rats were divided into 3 groups: 1 control and 2 irradiated groups, evaluated at 24 h (IR24) and 90 days (IR90) after exposure to 18 Gy of gamma radiation from a cobalt-60 radiotherapy source. The ECoG was analyzed using power spectrum methods for the calculation of the power of delta, theta, alpha and beta rhythms and by means of the α-exponent of the detrended fluctuation analysis (DFA). Using both mathematical methods it was possible to identify changes in the ECoG, and to identify significant changes in the pattern of the recording at 24 h after irradiation. Some of these changes were persistent at 90 days after exposure to IR. In particular, the theta wave using the two methods showed higher sensitivity than other waves, suggesting that it is a possible biomarker of exposure to IR.

Long-term correlation of the electrocorticogram as a bioindicator of brain exposure to ionizing radiation

PubMed Central

Aguiar, L.A.A.; Silva, I.M.S.; Fernandes, T.S.; Nogueira, R.A.

2015-01-01

Understanding the effects of radiation and its possible influence on the nervous system are of great clinical interest. However, there have been few electrophysiological studies on brain activity after exposure to ionizing radiation (IR). A new methodological approach regarding the assessment of the possible effects of IR on brain activity is the use of linear and nonlinear mathematical methods in the analysis of complex time series, such as brain oscillations measured using the electrocorticogram (ECoG). The objective of this study was to use linear and nonlinear mathematical methods as biomarkers of gamma radiation regarding cortical electrical activity. Adult Wistar rats were divided into 3 groups: 1 control and 2 irradiated groups, evaluated at 24 h (IR24) and 90 days (IR90) after exposure to 18 Gy of gamma radiation from a cobalt-60 radiotherapy source. The ECoG was analyzed using power spectrum methods for the calculation of the power of delta, theta, alpha and beta rhythms and by means of the α-exponent of the detrended fluctuation analysis (DFA). Using both mathematical methods it was possible to identify changes in the ECoG, and to identify significant changes in the pattern of the recording at 24 h after irradiation. Some of these changes were persistent at 90 days after exposure to IR. In particular, the theta wave using the two methods showed higher sensitivity than other waves, suggesting that it is a possible biomarker of exposure to IR. PMID:26445335

γ-oscillations modulated by picture naming and word reading: intracranial recording in epileptic patients.

PubMed

Wu, Helen C; Nagasawa, Tetsuro; Brown, Erik C; Juhasz, Csaba; Rothermel, Robert; Hoechstetter, Karsten; Shah, Aashit; Mittal, Sandeep; Fuerst, Darren; Sood, Sandeep; Asano, Eishi

2011-10-01

We measured cortical gamma-oscillations in response to visual-language tasks consisting of picture naming and word reading in an effort to better understand human visual-language pathways. We studied six patients with focal epilepsy who underwent extraoperative electrocorticography (ECoG) recording. Patients were asked to overtly name images presented sequentially in the picture naming task and to overtly read written words in the reading task. Both tasks commonly elicited gamma-augmentation (maximally at 80-100 Hz) on ECoG in the occipital, inferior-occipital-temporal and inferior-Rolandic areas, bilaterally. Picture naming, compared to reading task, elicited greater gamma-augmentation in portions of pre-motor areas as well as occipital and inferior-occipital-temporal areas, bilaterally. In contrast, word reading elicited greater gamma-augmentation in portions of bilateral occipital, left occipital-temporal and left superior-posterior-parietal areas. Gamma-attenuation was elicited by both tasks in portions of posterior cingulate and ventral premotor-prefrontal areas bilaterally. The number of letters in a presented word was positively correlated to the degree of gamma-augmentation in the medial occipital areas. Gamma-augmentation measured on ECoG identified cortical areas commonly and differentially involved in picture naming and reading tasks. Longer words may activate the primary visual cortex for the more peripheral field. The present study increases our understanding of the visual-language pathways. Copyright © 2011 International Federation of Clinical Neurophysiology. Published by Elsevier Ireland Ltd. All rights reserved.

Characterization of flexible ECoG electrode arrays for chronic recording in awake rats

PubMed Central

Yeager, John D.; Phillips, Derrick J.; Rector, David M.; Bahr, David F.

2008-01-01

We developed a 64 channel flexible polyimide ECoG electrode array and characterized its performance for long term implantation, chronic cortical recording and high resolution mapping of surface evoked potentials in awake rats. To achieve the longest possible recording periods, the flexibility of the electrode array, adhesion between the metals and carrier substrate, and biocompatibility was critical for maintaining the signal integrity. Experimental testing of thin film adhesion was applied to a gold – polyimide system in order to characterize relative interfacial fracture energies for several different adhesion layers, yielding an increase in overall device reliability. We tested several different adhesion techniques including: gold alone without an adhesion layer, titanium-tungsten, tantalum and chromium. We found the titanium-tungsten to be a suitable adhesion layer considering the biocompatibility requirements as well as stability and delamination resistance. While chromium and tantalum produced stronger gold adhesion, concerns over biocompatibility of these materials require further testing. We implanted the polyimide ECoG electrode arrays through a slit made in the skull of rats and recorded cortical surface evoked responses. The arrays performed reliably over a period of at least 100 days and signals compared well with traditional screw electrodes, with better high frequency response characteristics. Since the ultimate goal of chronically implanted electrode arrays is for neural prosthetic devices that need to last many decades, other adhesion layers that would prove safe for implantation may be tested in the same way in order to improve the device reliability. PMID:18640155

Random ensemble learning for EEG classification.

PubMed

Hosseini, Mohammad-Parsa; Pompili, Dario; Elisevich, Kost; Soltanian-Zadeh, Hamid

2018-01-01

Real-time detection of seizure activity in epilepsy patients is critical in averting seizure activity and improving patients' quality of life. Accurate evaluation, presurgical assessment, seizure prevention, and emergency alerts all depend on the rapid detection of seizure onset. A new method of feature selection and classification for rapid and precise seizure detection is discussed wherein informative components of electroencephalogram (EEG)-derived data are extracted and an automatic method is presented using infinite independent component analysis (I-ICA) to select independent features. The feature space is divided into subspaces via random selection and multichannel support vector machines (SVMs) are used to classify these subspaces. The result of each classifier is then combined by majority voting to establish the final output. In addition, a random subspace ensemble using a combination of SVM, multilayer perceptron (MLP) neural network and an extended k-nearest neighbors (k-NN), called extended nearest neighbor (ENN), is developed for the EEG and electrocorticography (ECoG) big data problem. To evaluate the solution, a benchmark ECoG of eight patients with temporal and extratemporal epilepsy was implemented in a distributed computing framework as a multitier cloud-computing architecture. Using leave-one-out cross-validation, the accuracy, sensitivity, specificity, and both false positive and false negative ratios of the proposed method were found to be 0.97, 0.98, 0.96, 0.04, and 0.02, respectively. Application of the solution to cases under investigation with ECoG has also been effected to demonstrate its utility. Copyright © 2017 Elsevier B.V. All rights reserved.

Mixture Design Applied to the Development of Chickpea-Based Gluten-Free Bread with Attractive Technological, Sensory, and Nutritional Quality.

PubMed

Santos, Fernanda G; Fratelli, Camilly; Muniz, Denise G; Capriles, Vanessa D

2018-01-01

The aim of the study was utilized chickpea to create appealing, nutritious, and palatable gluten-free bread (GFB). The performance of chickpea flour (CF) in single and composite GFB formulations was studied with a mixture design and response surface methodology. Six simplex-centroid designs for 3 ingredients were used to identify the ideal proportions of CF in various blends with cassava starch (CS), maize starch (MS), potato starch (PS), and rice flour (RF) achieving the best physical properties. For each design, 3 single, 3 binary, and 3 ternary formulations were prepared. The results showed that CF alone is suitable for bread production, resulting in GFB with higher volume and crumb firmness and lower crumb moisture than single formulations of other raw materials. However, the interactions between CF and PS or CS enhanced the loaf volume and decreased the crumb firmness values. The GFB prepared with only CF was accepted (overall acceptability score of 7.1- on a 10-cm scale). Nevertheless, the composite formulations prepared with CF75:PS25 or CF75:CS25 (flour basis) received overall acceptability scores of 8.2, like those of their white GFB, prepared with RF50:PS50 blend (flour basis), and wheat bread counterparts, used as positive controls. Compared to white GFB, both composite formulations presented nearly a twofold increase in ash and protein contents and a threefold increase in total fiber content. These results show that blends of CF75:PS25 or CF75:CS25 can be used to develop GFB with a good physical and sensory properties, as well as an enhanced nutritional composition. Gluten-free bread (GFB) made with 75% chickpea flour (CF) blend with 25% potato or cassava starch showed improved total minerals, protein and dietary fiber content and bread quality characteristics. Therefore, CF is a valuable ingredient for food technologists in manufacturing better-tasting and healthy GFB, which is important for consumers with gluten-related disorders since GFB often lack nutrition content, appearance, texture, and mouthfeel. © 2017 Institute of Food Technologists®.

Prolonged Elevated Heart Rate and 90-Day Survival in Acutely Ill Patients: Data From the MIMIC-III Database.

PubMed

Sandfort, Veit; Johnson, Alistair E W; Kunz, Lauren M; Vargas, Jose D; Rosing, Douglas R

2018-01-01

We sought to evaluate the association of prolonged elevated heart rate (peHR) with survival in acutely ill patients. We used a large observational intensive care unit (ICU) database (Multiparameter Intelligent Monitoring in Intensive Care III [MIMIC-III]), where frequent heart rate measurements were available. The peHR was defined as a heart rate >100 beats/min in 11 of 12 consecutive hours. The outcome was survival status at 90 days. We collected heart rates, disease severity (simplified acute physiology scores [SAPS II]), comorbidities (Charlson scores), and International Classification of Diseases (ICD) diagnosis information in 31 513 patients from the MIMIC-III ICU database. Propensity score (PS) methods followed by inverse probability weighting based on the PS was used to balance the 2 groups (the presence/absence of peHR). Multivariable weighted logistic regression was used to assess for association of peHR with the outcome survival at 90 days adjusting for additional covariates. The mean age was 64 years, and the most frequent main disease category was circulatory disease (41%). The mean SAPS II score was 35, and the mean Charlson comorbidity score was 2.3. Overall survival of the cohort at 90 days was 82%. Adjusted logistic regression showed a significantly increased risk of death within 90 days in patients with an episode of peHR ( P < .001; odds ratio for death 1.79; confidence interval, 1.69-1.88). This finding was independent of median heart rate. We found a significant association of peHR with decreased survival in a large and heterogenous cohort of ICU patients.

Unavailability of thymidine kinase does not preclude the use of German comprehensive prognostic index: results of an external validation analysis in early chronic lymphocytic leukemia and comparison with MD Anderson Cancer Center model.

PubMed

Molica, Stefano; Giannarelli, Diana; Mirabelli, Rosanna; Levato, Luciano; Russo, Antonio; Linardi, Maria; Gentile, Massimo; Morabito, Fortunato

2016-01-01

A comprehensive prognostic index that includes clinical (i.e., age, sex, ECOG performance status), serum (i.e., ß2-microglobulin, thymidine kinase [TK]), and molecular (i.e., IGVH mutational status, del 17p, del 11q) markers developed by the German CLL Study Group (GCLLSG) was externally validated in a prospective, community-based cohort consisting of 338 patients with early chronic lymphocytic leukemia (CLL) using as endpoint the time to first treatment (TTFT). Because serum TK was not available, a slightly modified version of the model based on seven instead of eight prognostic variables was used. By German index, 62.9% of patients were scored as having low-risk CLL (score 0-2), whereas 37.1% had intermediate-risk CLL (score 3-5). This stratification translated into a significant difference in the TTFT [HR = 4.21; 95% C.I. (2.71-6.53); P < 0.0001]. Also the 2007 MD Anderson Cancer Center (MDACC) score, barely based on traditional clinical parameters, showed comparable reliability [HR = 2.73; 95% C.I. (1.79-4.17); P < 0.0001]. A comparative performance assessment between the two models revealed that prediction of the TTFT was more accurate with German score. The c-statistic of the MDACC model was 0.65 (range, 0.53-0.78) a level below that of the German index [0.71 (range, 0.60-0.82)] and below the accepted 0.7 threshold necessary to have value at the individual patient level. Results of this external comparative validation analysis strongly support the German score as the benchmark for comparison of any novel prognostic scheme aimed at evaluating the TTFT in patients with early CLL even when a modified version which does not include TK is utilized. © 2015 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

On the Bias-Amplifying Effect of Near Instruments in Observational Studies

ERIC Educational Resources Information Center

Steiner, Peter M.; Kim, Yongnam

2014-01-01

In contrast to randomized experiments, the estimation of unbiased treatment effects from observational data requires an analysis that conditions on all confounding covariates. Conditioning on covariates can be done via standard parametric regression techniques or nonparametric matching like propensity score (PS) matching. The regression or…

Does the grading of chondromalacia patellae influence anterior knee pain following total knee arthroplasty without patellar resurfacing?

PubMed

Zha, Guo-Chun; Feng, Shuo; Chen, Xiang-Yang; Guo, Kai-Jin

2018-03-01

The influence of chondromalacia patellae (CMP) on post-operative anterior knee pain (AKP) following total knee arthroplasty (TKA) remains controversial, and few studies have focused on the relationship between them. The purpose of this study was to determine whether different CMP grades affect the incidence of AKP after TKA without patellar resurfacing. We performed a retrospective analysis of prospectively collected data on 290 TKAs with the use of the low contact stress mobile-bearing prosthesis, without patellar resurfacing in 290 patients from February 2009 to January 2013. Patients were assessed by the Outerbridge classification for CMP, visual analog scale for AKP, the Knee Society clinical scoring system of knee score (KS), function score (FS), the patellar score (PS) for clinical function, and patients' satisfaction. The intra-operative grading of CMP: grade I in 30 patients, grade II in 68 patients, grade III in 97 patients, and grade IV in 95 patients. The incidence of AKP at 36-month follow-up was 10.3% (30/290). No statistical difference was detected among the different CMP grades in terms of the incidence of AKP (p = 0.995), patients' satisfaction (p = 0.832), KS (p = 0.228), FS (p = 0.713), and PS (p = 0.119) at 36-month follow-up. The findings may suggest no relevant influence of CMP grading on the incidence of AKP after TKA without patellar resurfacing.

A Randomized Trial of the Effects of Schema-Based Instruction on Proportional Problem-Solving for Students With Mathematics Problem-Solving Difficulties.

PubMed

Jitendra, Asha K; Harwell, Michael R; Dupuis, Danielle N; Karl, Stacy R

This article reports results from a study investigating the efficacy of a proportional problem-solving intervention, schema-based instruction (SBI), in seventh grade. Participants included 806 students with mathematical difficulties in problem solving (MD-PS) from an initial pool of 1,999 seventh grade students in a larger study. Teachers and their students in the larger study were randomly assigned to an SBI or control condition and teachers in both conditions then provided instruction on the topics of ratio, proportion, and percent. We found that students with MD-PS in SBI classrooms scored on average higher than their counterparts in control classrooms on a posttest and delayed posttest administered 9 weeks later. Given students' difficulties with proportional problem-solving and the consequences of these difficulties, an important contribution of this research is the finding that when provided with appropriate instruction, students with MD-PS are capable of enhanced proportional problem-solving performance.

Patient volume per surgeon does not predict survival in adult level I trauma centers.

PubMed

Margulies, D R; Cryer, H G; McArthur, D L; Lee, S S; Bongard, F S; Fleming, A W

2001-04-01

The 1999 American College of Surgeons resources for optimal care document added the requirement that Level I trauma centers admit over 240 patients with Injury Severity Score (ISS) > 15 per year or that trauma surgeons care for at least 35 patients per year. The purpose of this study was to test the hypothesis that high volume of patients with ISS > 15 per individual trauma surgeon is associated with improved outcome. Data were obtained from the trauma registry of the five American College of Surgeons-verified adult Level I trauma centers in our mature trauma system between January 1, 1998, and March 31, 1999. Data abstracted included age, sex, Glasgow Coma Scale (GCS) score, intensive care unit length of stay, hospital length of stay, probability of survival (Ps), mechanism of injury, number of patients per each trauma surgeon and institution, and mortality. Multiple logistic regression was performed to select independent variables for modeling of survival. From the five Level I centers there were 11,932 trauma patients in this time interval; of these, 1,754 patients (14.7%) with ISS > 15 were identified and used for analysis. Patients with ISS > 15 varied from 173 to 625 per institution; trauma surgeons varied from 8 to 25 per institution; per-surgeon patient volume varied from 0.8 to 96 per year. Logistic regression analysis revealed that the best independent predictors of survival were Ps, GCS score, age, mechanism of injury, and institutional volume (p < 0.01). Age and institutional volume correlated negatively with survival. Analysis of per-surgeon patient caseload added no additional predictive value (p = 0.44). The significant independent predictors of survival in severely injured trauma patients are Ps, GCS score, age, mechanism of injury, and institutional volume. We found no statistically meaningful contribution to the prediction of survival on the basis of per-surgeon patient volume. Since this volume criterion for surgeon enpanelment and trauma center designation would not be expected to improve outcome, such a requirement should be justified by other measures or abandoned.

Online Group Course for Parents With Mental Illness: Development and Pilot Study

PubMed Central

Speetjens, Paula AM; Arntz, Karlijn SE; Onrust, Simone A

2010-01-01

Background Children of parents with mental illness (COPMI) are at greater risk of developing mental disorders themselves. Since impaired parenting skills appear to be a crucial factor, we developed a facilitated 8-session preventative group course called KopOpOuders (Chin Up, Parents) delivered via the Internet to Dutch parents with psychiatric problems. The goal was to promote children’s well-being by strengthening children’s protective factors via their parents. To reach parents at an early stage of their parenting difficulties, the course is easily accessible online. The course is delivered in a secure chat room, and participation is anonymous. Objective This paper reports on (1) the design and method of this online group course and (2) the results of a pilot study that assessed parenting skills, parental sense of competence, child well-being, and course satisfaction. Method The pilot study had a pre/post design. Parenting skills were assessed using Laxness and Overreactivity subscales of the Parenting Scale (PS). Sense of parenting competence was measured with the Ouderlijke Opvattingen over Opvoeding (OOO) questionnaire, a Dutch scale assessing parental perceptions of parenting using the Feelings of Incompetence and Feelings of Competence subscales. Child well-being was assessed with the total problem score, Emotional Problems, and Hyperactivity subscales of the Strengths and Difficulties Questionnaire (SDQ). Paired samples t tests were performed, and Cohen’s d was used to determine effect sizes. Intention-to-treat analyses and analyses of completers only were both performed. Course satisfaction was evaluated using custom-designed questionnaires. Results The sample comprised 48 parents with mental illness. The response rate was 100% (48/48) at pretest and 58% (28/48) at posttest. Significant improvements were found on PS Laxness and Overreactivity subscales (P < .01) and on the OOO Feelings of Incompetence and Competence subscales (P < .01) in analysis of completers only as well as by intention-to-treat analysis. Effects were moderate on the PS (d = .52 and d = .48) and were large and moderate on the OOO (d = 0.61 and d = 0.46). At pretest, 75% and 64% of PS scores were in the clinical range, which declined to 43% and 39% at posttest. No significant changes were found for child well-being. Scores for approximately two thirds of children were not in the clinical range at both pretest and posttest. The mean course satisfaction score was 7.8 on a 10-point scale. Of all participants, 20% (10/48) followed all the sessions. Conclusion This online group course on parenting skills is innovative in the field of e-support and among interventions for mentally ill parents. The pilot results are promising, showing moderate to large effects for parenting skills and parental sense of competence. Test scores at baseline indicating parenting problems were largely in the clinical range, and baseline scores indicating problems among the children were in the nonclinical range, suggesting that parents were reached at an early stage. Course satisfaction was high. Future research should focus on cost effectiveness and course adherence. PMID:21169178

Online group course for parents with mental illness: development and pilot study.

PubMed

van der Zanden, Rianne A P; Speetjens, Paula A M; Arntz, Karlijn S E; Onrust, Simone A

2010-12-19

Children of parents with mental illness (COPMI) are at greater risk of developing mental disorders themselves. Since impaired parenting skills appear to be a crucial factor, we developed a facilitated 8-session preventative group course called KopOpOuders (Chin Up, Parents) delivered via the Internet to Dutch parents with psychiatric problems. The goal was to promote children's well-being by strengthening children's protective factors via their parents. To reach parents at an early stage of their parenting difficulties, the course is easily accessible online. The course is delivered in a secure chat room, and participation is anonymous. This paper reports on (1) the design and method of this online the group course and (2) the results of a pilot study that assessed parenting skills, parental sense of competence, child well-being, and course satisfaction. The pilot study had a pre/post design. Parenting skills were assessed using Laxness and Overreactivity subscales of the Parenting Scale (PS). Sense of parenting competence was measured with the Ouderlijke Opvattingen over Opvoeding (OOO) questionnaire, a Dutch scale assessing parental perceptions of parenting using the Feelings of Incompetence and Feelings of Competence subscales. Child well-being was assessed with the total problem score, Emotional Problems, and Hyperactivity subscales of the Strengths and Difficulties Questionnaire (SDQ). Paired samples t tests were performed, and Cohen's d was used to determine effect sizes. Intention-to-treat analyses and analyses of completers only were both performed. Course satisfaction was evaluated using custom-designed questionnaires. The sample comprised 48 parents with mental illness. The response rate was 100% (48/48) at pretest and 58% (28/48) at posttest. Significant improvements were found on PS Laxness and Overreactivity subscales (P < .01) and on the OOO Feelings of Incompetence and Competence subscales (P < .01) in analysis of completers only as well as by intention-to-treat analysis. Effects were moderate on the PS (d = .52 and d = .48) and were large and moderate on the OOO (d = 0.61 and d = 0.46). At pretest, 75% and 64% of PS scores were in the clinical range, which declined to 43% and 39% at posttest. No significant changes were found for child well-being. Scores for approximately two thirds of children were not in the clinical range at both pretest and posttest. The mean course satisfaction score was 7.8 on a 10-point scale. Of all participants, 20% (10/48) followed all the sessions. This online group course on parenting skills is innovative in the field of e-support and among interventions for mentally ill parents. The pilot results are promising, showing moderate to large effects for parenting skills and parental sense of competence. Test scores at baseline indicating parenting problems were largely in the clinical range, and baseline scores indicating problems among the children were in the nonclinical range, suggesting that parents were reached at an early stage. Course satisfaction was high. Future research should focus on cost effectiveness and course adherence.

Crizotinib in patients with anaplastic lymphoma kinase-positive advanced non-small cell lung cancer versus chemotherapy as a first-line treatment.

PubMed

Zhou, Jianya; Zheng, Jing; Zhang, Xiaochen; Zhao, Jing; Zhu, Yanping; Shen, Qian; Wang, Yuehong; Sun, Ke; Zhang, Zeying; Pan, Zhijie; Shen, Yihong; Zhou, Jianying

2018-01-03

To compare the efficacy of crizotinib, pemetrexed and other chemotherapy regimens as a first-line treatment in patients with anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC) in real world clinical use and to evaluate the +86-571-87,236,876 predictive clinical factors of the efficacy of crizotinib. The 73 patients with ALK-positive advanced NSCLC were divided into three groups based on the first-line treatment: first-line crizotinib group (1-CRZ group, n = 32); first-line platinum-based pemetrexed treatment group (1-PP group, n = 28), and first-line chemotherapy platinum-based non-pemetrexed group (N1-PP, n = 12). Sixty eight of the 73 patients received crizotinib treatment and followed up in our hospital. Differences in the objective response rate (ORR), disease control rate (DCR) and progression-free survival (PFS) were compared in the different groups. The clinical factors were evaluated to predict the efficacy of crizotinib by the Kaplan-Meier survival analysis and Cox proportional hazards model. The PFS, ORR, DCR were 16.1 months, 78.1% (25/32) and 100% (32/32) in the 1-CRZ group; were 6.0 months, 17.9% (5/28) and 57.2% (16/28) in the 1-PP group; and were 2.9 months, 15.4% (2/13) and 46.2% (6/13) in the N1-PP group. The PFS of the 1-CRZ group was significantly longer than that of the 1-PP group (P < 0.001) and the N1-PP group (P < 0.001). The ORR and DCR of the 1-CRZ group was significantly greater than that of the 1-PP group and the N1-PP group (all the P < 0.001). Higher Eastern Cooperative Oncology Group (ECOG) performance status score (> = 2) (HR 2.345, 95% CI 1.137-4.834, P = 0.021) and patients received crizotinib after N1-PP chemotherapy (HR 2.345, 95% CI 1.137-4.834, P = 0.021) were two factors associated with shorter PFS after crizotinib treatment. In patients with ALK-positive NSCLC who did not receive previous treatment, crizotinib was superior to standard chemotherapy for the longer PFS and greater ORR and DCR. Higher ECOG score (> = 2) and patients received crizotinib after N1-PP chemotherapy predict poor efficacy of crizotinib.

Semi-automated Anatomical Labeling and Inter-subject Warping of High-Density Intracranial Recording Electrodes in Electrocorticography.

PubMed

Hamilton, Liberty S; Chang, David L; Lee, Morgan B; Chang, Edward F

2017-01-01

In this article, we introduce img_pipe, our open source python package for preprocessing of imaging data for use in intracranial electrocorticography (ECoG) and intracranial stereo-EEG analyses. The process of electrode localization, labeling, and warping for use in ECoG currently varies widely across laboratories, and it is usually performed with custom, lab-specific code. This python package aims to provide a standardized interface for these procedures, as well as code to plot and display results on 3D cortical surface meshes. It gives the user an easy interface to create anatomically labeled electrodes that can also be warped to an atlas brain, starting with only a preoperative T1 MRI scan and a postoperative CT scan. We describe the full capabilities of our imaging pipeline and present a step-by-step protocol for users.

Modeling vocalization with ECoG cortical activity recorded during vocal production in the macaque monkey.

PubMed

Fukushima, Makoto; Saunders, Richard C; Fujii, Naotaka; Averbeck, Bruno B; Mishkin, Mortimer

2014-01-01

Vocal production is an example of controlled motor behavior with high temporal precision. Previous studies have decoded auditory evoked cortical activity while monkeys listened to vocalization sounds. On the other hand, there have been few attempts at decoding motor cortical activity during vocal production. Here we recorded cortical activity during vocal production in the macaque with a chronically implanted electrocorticographic (ECoG) electrode array. The array detected robust activity in motor cortex during vocal production. We used a nonlinear dynamical model of the vocal organ to reduce the dimensionality of `Coo' calls produced by the monkey. We then used linear regression to evaluate the information in motor cortical activity for this reduced representation of calls. This simple linear model accounted for circa 65% of the variance in the reduced sound representations, supporting the feasibility of using the dynamical model of the vocal organ for decoding motor cortical activity during vocal production.

Extracellular matrix proteins as temporary coating for thin-film neural implants

NASA Astrophysics Data System (ADS)

Ceyssens, Frederik; Deprez, Marjolijn; Turner, Neill; Kil, Dries; van Kuyck, Kris; Welkenhuysen, Marleen; Nuttin, Bart; Badylak, Stephen; Puers, Robert

2017-02-01

Objective. This study investigates the suitability of a thin sheet of extracellular matrix (ECM) proteins as a resorbable coating for temporarily reinforcing fragile or ultra-low stiffness thin-film neural implants to be placed on the brain, i.e. microelectrocorticographic (µECOG) implants. Approach. Thin-film polyimide-based electrode arrays were fabricated using lithographic methods. ECM was harvested from porcine tissue by a decellularization method and coated around the arrays. Mechanical tests and an in vivo experiment on rats were conducted, followed by a histological tissue study combined with a statistical equivalence test (confidence interval approach, 0.05 significance level) to compare the test group with an uncoated control group. Main results. After 3 months, no significant damage was found based on GFAP and NeuN staining of the relevant brain areas. Significance. The study shows that ECM sheets are a suitable temporary coating for thin µECOG neural implants.

A Multimodal, SU-8 - Platinum - Polyimide Microelectrode Array for Chronic In Vivo Neurophysiology

PubMed Central

Márton, Gergely; Orbán, Gábor; Kiss, Marcell; Fiáth, Richárd; Pongrácz, Anita; Ulbert, István

2015-01-01

Utilization of polymers as insulator and bulk materials of microelectrode arrays (MEAs) makes the realization of flexible, biocompatible sensors possible, which are suitable for various neurophysiological experiments such as in vivo detection of local field potential changes on the surface of the neocortex or unit activities within the brain tissue. In this paper the microfabrication of a novel, all-flexible, polymer-based MEA is presented. The device consists of a three dimensional sensor configuration with an implantable depth electrode array and brain surface electrodes, allowing the recording of electrocorticographic (ECoG) signals with laminar ones, simultaneously. In vivo recordings were performed in anesthetized rat brain to test the functionality of the device under both acute and chronic conditions. The ECoG electrodes recorded slow-wave thalamocortical oscillations, while the implanted component provided high quality depth recordings. The implants remained viable for detecting action potentials of individual neurons for at least 15 weeks. PMID:26683306

[Improved methods for monitoring sleep state and respiratory rhythm in freely moving rats].

PubMed

Wang, Qi-Min; Dong, Hui; Zhang, Cheng; Zhang, Yong-He; Ma, Jing; Wang, Guang-Fa

2014-01-01

To improve the method for monitoring sleep state and respiratory rhythm of SD rats, providing a solution for rats' chewing on the wires, signal loss and instability problems in the animal model of sleep apnea syndrome (SAS). We improved monitoring electrodes of both electrocorticogram (ECoG) and electromyogram (EMG), signal circuit and animal operation. Operation time was shortened and wound exposure time was reduced, which made it easier for postoperative recovery. The ECoG and EMG signals were more stable with sharp image, and signal circuit lines had better conductivity and material durability, achieving continuous monitoring for a long time and high success rate. We could precisely distinguish the sleep wake state and the sleep apnea events in rats according to these signals. The improved method is more reliable and practical to test the small animal model of SAS, and is more easily to operate and the signals are more stable.

A Multimodal, SU-8 - Platinum - Polyimide Microelectrode Array for Chronic In Vivo Neurophysiology.

PubMed

Márton, Gergely; Orbán, Gábor; Kiss, Marcell; Fiáth, Richárd; Pongrácz, Anita; Ulbert, István

2015-01-01

Utilization of polymers as insulator and bulk materials of microelectrode arrays (MEAs) makes the realization of flexible, biocompatible sensors possible, which are suitable for various neurophysiological experiments such as in vivo detection of local field potential changes on the surface of the neocortex or unit activities within the brain tissue. In this paper the microfabrication of a novel, all-flexible, polymer-based MEA is presented. The device consists of a three dimensional sensor configuration with an implantable depth electrode array and brain surface electrodes, allowing the recording of electrocorticographic (ECoG) signals with laminar ones, simultaneously. In vivo recordings were performed in anesthetized rat brain to test the functionality of the device under both acute and chronic conditions. The ECoG electrodes recorded slow-wave thalamocortical oscillations, while the implanted component provided high quality depth recordings. The implants remained viable for detecting action potentials of individual neurons for at least 15 weeks.

A clinic compatible, open source electrophysiology system.

PubMed

Hermiz, John; Rogers, Nick; Kaestner, Erik; Ganji, Mehran; Cleary, Dan; Snider, Joseph; Barba, David; Dayeh, Shadi; Halgren, Eric; Gilja, Vikash

2016-08-01

Open source electrophysiology (ephys) recording systems have several advantages over commercial systems such as customization and affordability enabling more researchers to conduct ephys experiments. Notable open source ephys systems include Open-Ephys, NeuroRighter and more recently Willow, all of which have high channel count (64+), scalability, and advanced software to develop on top of. However, little work has been done to build an open source ephys system that is clinic compatible, particularly in the operating room where acute human electrocorticography (ECoG) research is performed. We developed an affordable (<; $10,000) and open system for research purposes that features power isolation for patient safety, compact and water resistant enclosures and 256 recording channels sampled up to 20ksam/sec, 16-bit. The system was validated by recording ECoG with a high density, thin film device for an acute, awake craniotomy study at UC San Diego, Thornton Hospital Operating Room.

Using max entropy ratio of recurrence plot to measure electrocorticogram changes in epilepsy patients

NASA Astrophysics Data System (ADS)

Yan, Jiaqing; Wang, Yinghua; Ouyang, Gaoxiang; Yu, Tao; Li, Xiaoli

2016-02-01

A maximum entropy ratio (MER) method is firstly adapted to investigate the high-dimensional Electrocorticogram (ECoG) data from epilepsy patients. MER is a symbolic analysis approach for the detection of recurrence domains of complex dynamical systems from time series. Data were chosen from eight patients undergoing pre-surgical evaluation for drug-resistant temporal lobe epilepsy. MERs for interictal and ictal data were calculated and compared. A statistical test was performed to evaluate the ability of MER to separate the interictal state from the ictal state. MER showed significant changes from the interictal state into the ictal state, where MER was low at the ictal state and is significantly different with that at the interictal state. These suggest that MER is able to separate the ictal state from the interictal state based on ECoG data. It has the potential of detecting the transition between normal brain activity and the ictal state.

Global Interactions Analysis of Epileptic ECoG Data

NASA Astrophysics Data System (ADS)

Ortega, Guillermo J.; Sola, Rafael G.; Pastor, Jesús

2007-05-01

Localization of the epileptogenic zone is an important issue in epileptology, even though there is not a unique definition of the epileptic focus. The objective of the present study is to test ultrametric analysis to uncover cortical interactions in human epileptic data. Correlation analysis has been carried out over intraoperative Electro-Corticography (ECoG) data in 2 patients suffering from temporal lobe epilepsy (TLE). Recordings were obtained using a grid of 20 electrodes (5×4) covering the lateral temporal lobe and a strip of either 4 or 8 electrodes at the mesial temporal lobe. Ultrametric analysis was performed in the averaged final correlation matrices. By using the matrix of linear correlation coefficients and the appropriate metric distance between pairs of electrodes time series, we were able to construct Minimum Spanning Trees (MST). The topological connectivity displayed by these trees gives useful and valuable information regarding physiological and pathological information in the temporal lobe of epileptic patients.

Semi-automated Anatomical Labeling and Inter-subject Warping of High-Density Intracranial Recording Electrodes in Electrocorticography

PubMed Central

Hamilton, Liberty S.; Chang, David L.; Lee, Morgan B.; Chang, Edward F.

2017-01-01

In this article, we introduce img_pipe, our open source python package for preprocessing of imaging data for use in intracranial electrocorticography (ECoG) and intracranial stereo-EEG analyses. The process of electrode localization, labeling, and warping for use in ECoG currently varies widely across laboratories, and it is usually performed with custom, lab-specific code. This python package aims to provide a standardized interface for these procedures, as well as code to plot and display results on 3D cortical surface meshes. It gives the user an easy interface to create anatomically labeled electrodes that can also be warped to an atlas brain, starting with only a preoperative T1 MRI scan and a postoperative CT scan. We describe the full capabilities of our imaging pipeline and present a step-by-step protocol for users. PMID:29163118

Impact of providing psychiatry specialty pharmacist intervention on reducing drug-related problems among children with autism spectrum disorder related to disruptive behavioural symptoms: A prospective randomized open-label study.

PubMed

Wongpakaran, R; Suansanae, T; Tan-Khum, T; Kraivichian, C; Ongarjsakulman, R; Suthisisang, C

2017-06-01

Psychopharmacologic therapy has so far focused on ameliorating disruptive behaviours to improve patient's function and quality of life. Due to the complicated neurobiological aetiology of autism spectrum disorder (ASD), a traditional pharmacist intervention may be insufficient to initiate the optimal care for this vulnerable population. We evaluate the impact of providing specialty psychiatry (PS) pharmacist intervention in identifying and resolving drug-related problems (DRPs) among children with ASD associated with disruptive behaviours. An eight-week-long, prospective, randomized open-label study was conducted. Children between 2.5 and 12 years of age with ASD and showing disruptive behaviours were included. They were randomly assigned to an intervention or a control group. Patients in the intervention group received pharmacist interventions delivered by a PS pharmacist, while those in control group were cared by a hospital pharmacist. The primary outcome was the number of patients who resolved of at least one DRP by the end of the study. The secondary outcome was to compare the mean Aberrant Behavior Checklist-Irritability (ABC-I) scores between the two groups. Twenty-five patients were randomly assigned to either an intervention or control group. At week 8, the total number of patients who resolved of at least one DRP was 13 (52%) in the intervention group and 4 (16%) in the control group, respectively (P=.016). Improper drug selection, medication non-adherence and subtherapeutic dosage were the most common DRPs. Mean ABC-I scores improved in the intervention group more than in the control group (9.8±5.6 vs 17.7±7.9; P<.001). To the best of our knowledge, this is the first study which demonstrated that PS pharmacist intervention is an effective strategy to resolve DRPs in patient with ASD. The reduction in common DRPs mostly resulted from the PS pharmacist interventions, including selection of antipsychotic agent, adjustment of dosage based on ABC-I scores and provision of individualized drug counselling. Reducing DRPs led to the improvement of any disruptive behaviour. In addition, multidisciplinary team should develop drug therapy protocols to promote the role of pharmacists in this setting. © 2017 John Wiley & Sons Ltd.

Synovial features of patients with rheumatoid arthritis and psoriatic arthritis in clinical and ultrasound remission differ under anti-TNF therapy: a clue to interpret different chances of relapse after clinical remission?

PubMed

Alivernini, Stefano; Tolusso, Barbara; Petricca, Luca; Bui, Laura; Di Sante, Gabriele; Peluso, Giusy; Benvenuto, Roberta; Fedele, Anna Laura; Federico, Franco; Ferraccioli, Gianfranco; Gremese, Elisa

2017-07-01

To define the synovial characteristics of patients with rheumatoid arthritis (RA) and psoriatic arthritis (PsA) in clinical and ultrasound remission achieved by combination therapy with methotrexate (MTX) and tumour necrosis factor (TNF) blockers. Patients with RA in remission (n=25) (disease activity score (DAS)<1.6 for at least 6 months), patients with RA in low disease activity (LDA) (n=10) (1.6

Group for Research and Assessment of Psoriasis and Psoriatic Arthritis/Outcome Measures in Rheumatology Consensus-Based Recommendations and Research Agenda for Use of Composite Measures and Treatment Targets in Psoriatic Arthritis.

PubMed

Coates, Laura C; FitzGerald, Oliver; Merola, Joseph F; Smolen, Josef; van Mens, Leonieke J J; Bertheussen, Heidi; Boehncke, Wolf-Henning; Callis Duffin, Kristina; Campbell, Willemina; de Wit, Maarten; Gladman, Dafna; Gottlieb, Alice; James, Jana; Kavanaugh, Arthur; Kristensen, Lars Erik; Kvien, Tore K; Luger, Thomas; McHugh, Neil; Mease, Philip; Nash, Peter; Ogdie, Alexis; Rosen, Cheryl F; Strand, Vibeke; Tillett, William; Veale, Douglas J; Helliwell, Philip S

2018-03-01

A meeting was convened by the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) and Outcome Measures in Rheumatology (OMERACT) to further the development of consensus among physicians and patients regarding composite disease activity measures and targets in psoriatic arthritis (PsA). Prior to the meeting, physicians and patients completed surveys on outcome measures. A consensus meeting of 26 rheumatologists, dermatologists, and patient research partners reviewed evidence on composite measures and potential treatment targets plus results of the surveys. The meeting consisted of plenary presentations, breakout sessions, and group discussions. International experts including members of GRAPPA and OMERACT were invited to the meeting, including the developers of all of the measures discussed. After discussions, participants voted on proposals for use, and consensus was established in a second survey. Survey results from 128 health care professionals and 139 patients were analyzed alongside a systematic literature review summarizing evidence. A weighted vote was cast for composite measures. For randomized controlled trials, the most popular measures were the PsA disease activity score (40 votes) and the GRAPPA composite index (28 votes). For clinical practice, the most popular measures were an average of scores on 3 visual analog scales (45 votes) and the disease activity in PsA score (26 votes). After discussion, there was no consensus on a composite measure. The group agreed that several composite measures could be used and that future studies should allow further validation and comparison. The group unanimously agreed that remission should be the ideal target, with minimal disease activity (MDA)/low disease activity as a feasible alternative. The target should include assessment of musculoskeletal disease, skin disease, and health-related quality of life. The group recommended a treatment target of very low disease activity (VLDA) or MDA. Consensus was not reached on a continuous measure of disease activity. In the interim, the group recommended several composites. Consensus was reached on a treatment target of VLDA/MDA. An extensive research agenda was composed and recommends that data on all PsA clinical domains be collected in ongoing studies. © 2017, American College of Rheumatology.

Synovial features of patients with rheumatoid arthritis and psoriatic arthritis in clinical and ultrasound remission differ under anti-TNF therapy: a clue to interpret different chances of relapse after clinical remission?

PubMed Central

Alivernini, Stefano; Tolusso, Barbara; Petricca, Luca; Bui, Laura; Di Sante, Gabriele; Peluso, Giusy; Benvenuto, Roberta; Fedele, Anna Laura; Federico, Franco; Ferraccioli, Gianfranco; Gremese, Elisa

2017-01-01

Objective To define the synovial characteristics of patients with rheumatoid arthritis (RA) and psoriatic arthritis (PsA) in clinical and ultrasound remission achieved by combination therapy with methotrexate (MTX) and tumour necrosis factor (TNF) blockers. Methods Patients with RA in remission (n=25) (disease activity score (DAS)<1.6 for at least 6 months), patients with RA in low disease activity (LDA) (n=10) (1.6

Synthesis of phosphatidylcholine in rats with oleic acid-induced pulmonary edema and effect of exogenous pulmonary surfactant on its De Novo synthesis.

PubMed

Gao, Xiwen; Qian, Peiyu; Cen, Dong; Hong, Weijun; Peng, Qing; Xue, Min

2018-01-01

In mammals, oleic acid (OA) induces pulmonary edema (PE), which can initiate acute lung injury (ALI) and lead to acute respiratory distress syndrome (ARDS). Pulmonary surfactant (PS) plays a key role in a broad range of treatments for ARDS. The aim of the present investigation was to assess changes in the synthesis of phosphatidylcholine (PC) from choline and determine the effect of exogenous PS on its de novo synthesis in rats with OA-induced PE. Experimental rats were randomized into three groups, including a control group, OA-induced PE group, and OA-induced group treated with exogenous PS (OA-PS). Twenty-four rats were sacrificed 4 h after induction of the OA model, and tissue was examined by light and electron microscopy to assess the severity of ALI using an established scoring system at the end of the experiment. After 15 μCi 3H-choline chloride was injected intravenously, eight rats in each group were sacrificed at 4, 8, and 16 h. The radioactivity of 3H incorporated into total phospholipid (TPL) and desaturated phosphatidylcholine (DSPC) was measured in bronchoalveolar lavage fluid (BALF) and lung tissue (LT) using a liquid scintillation counter and was expressed as counts per minute (CPM). Results showed that TPL, DSPC, and the ratio of DSPC/total protein (TP) in lung tissue decreased 4 h after challenge with OA, but the levels recovered after 8 and 16 h. At 8 h after injection, 3H-TPL and 3H-DSPC radioactivity in the lungs reached its peak. Importantly, 3H-DSPC CPM were significantly lower in the PS treatment group (LT: Control: 62327 ± 9108; OA-PE: 97315 ± 10083; OA-PS: 45127 ± 10034, P < 0.05; BALF: Control: 7771 ± 1768; OA-PE: 8097 ± 1799; OA-PE: 3651 ± 1027, P < 0.05). Furthermore, DSPC secretory rate (SR) in the lungs was significantly lower in the PS treatment group at 4 h after injection (Control: 0.014 ± 0.003; OA-PE: 0.011 ± 0.004; OA-PS: 0.023 ± 0.006, P < 0.05). Therefore, we hypothesize that exogenous PS treatments may adversely affect endogenous de novo synthetic and secretory phospholipid pathways via feedback inhibition. This novel finding reveals the specific involvement of exogenous PS in endogenous synthetic and secretory phospholipid pathways during the treatment of ARDS. This information improves our understanding of how PS treatment is beneficial against ARDS and opens new opportunities for expanding its use.

Phase 2 Study of Acupuncture-Like Transcutaneous Nerve Stimulation for Chemotherapy-Induced Peripheral Neuropathy

PubMed Central

Wong, Raimond; Major, Pierre; Sagar, Stephen

2016-01-01

A prospective phase 2 study was conducted to evaluate the clinical utility of acupuncture-like transcutaneous nerve stimulation (ALTENS) for the treatment of chemotherapy-induced peripheral neuropathy (CIPN). Eligible cancer patients had a < 2 ECOG performance score, received neurotoxic chemotherapy, and developed CIPN symptoms for > two months. Randomization was used to eliminate bias in patient selection for ALTENS and was not to compare the effectiveness between the two treatments.ALTENS treatments were delivered using Codetron units. Bilateral acupuncture points included LI4 and LIV3, plus LI11 or ST36 were stimulated. Acupuncture treatments were administered to CV6, SP6, ST6, LI11, Bafeng, Baxie and selective Jing points bilaterally. Twelve treatments were delivered twice weekly over 6 to 8 weeks. The Modified Total Neuropathy Score (mTNS), Numbness Score, and Edmonton Symptom Assessment Score (ESAS) were assessed at baseline, treatment completion, plus at 3 and 6 months follow-up. The primary study endpoint was mTNS score at 6 months. We planned to recruit 23 patients into each group. After 30 patients were recruited, 2 were lost to follow-up at 3 months in the ALTENS group and 3 in the acupuncture group. The research team decided to recruit all remaining consecutive patients only to the ALTENS group to ensure an adequate evaluation of ALTENS, the primary object of evaluation. There were 27 patients in the ALTENS group, with an average symptom duration of 10 months after chemotherapy. Twenty four and 23 patients completed the 3 and 6 month follow-up respectively. The median mTNS scores were 7.1, 4.0, 3.6 and 3.1 at baseline, treatment completion, 3 and 6 months follow-up, respectively. One-way ANOVA analysis showed a significant improvement in mTNS scores (p<0.001) at 6 months. Numbness scores were also significantly improved at 6 months. ESAS pain scores and perception of well-being scores analyses were inconclusive. There were no significant reported side effects of ALTENS. There were only 13 patients in the acupuncture group and the number was insufficient for either an independent or a comparative analysis. The results of this study suggests that ALTENS significantly reduces the mTNS scores and numbness in patients suffering from CIPN symptoms. PMID:27130723

psRNATarget: a plant small RNA target analysis server

PubMed Central

Dai, Xinbin; Zhao, Patrick Xuechun

2011-01-01

Plant endogenous non-coding short small RNAs (20–24 nt), including microRNAs (miRNAs) and a subset of small interfering RNAs (ta-siRNAs), play important role in gene expression regulatory networks (GRNs). For example, many transcription factors and development-related genes have been reported as targets of these regulatory small RNAs. Although a number of miRNA target prediction algorithms and programs have been developed, most of them were designed for animal miRNAs which are significantly different from plant miRNAs in the target recognition process. These differences demand the development of separate plant miRNA (and ta-siRNA) target analysis tool(s). We present psRNATarget, a plant small RNA target analysis server, which features two important analysis functions: (i) reverse complementary matching between small RNA and target transcript using a proven scoring schema, and (ii) target-site accessibility evaluation by calculating unpaired energy (UPE) required to ‘open’ secondary structure around small RNA’s target site on mRNA. The psRNATarget incorporates recent discoveries in plant miRNA target recognition, e.g. it distinguishes translational and post-transcriptional inhibition, and it reports the number of small RNA/target site pairs that may affect small RNA binding activity to target transcript. The psRNATarget server is designed for high-throughput analysis of next-generation data with an efficient distributed computing back-end pipeline that runs on a Linux cluster. The server front-end integrates three simplified user-friendly interfaces to accept user-submitted or preloaded small RNAs and transcript sequences; and outputs a comprehensive list of small RNA/target pairs along with the online tools for batch downloading, key word searching and results sorting. The psRNATarget server is freely available at http://plantgrn.noble.org/psRNATarget/. PMID:21622958

Predictors of upper trapezius pain with myofascial trigger points in food service workers: The STROBE study.

PubMed

Hwang, Ui-Jae; Kwon, Oh-Yun; Yi, Chung-Hwi; Jeon, Hye-Seon; Weon, Jong-Hyuck; Ha, Sung-Min

2017-06-01

Shoulder pain occurs commonly in food service workers (FSWs) who repetitively perform motions of the upper limbs. Myofascial trigger points (MTrPs) on the upper trapezius (UT) are among the most common musculoskeletal shoulder pain syndromes. This study determined the psychological, posture, mobility, and strength factors associated with pain severity in FSWs with UT pain due to MTrPs.In this cross-sectional study, we measured 17 variables in 163 FSWs with UT pain due to MTrPs: a visual analog scale (VAS) pain score, age, sex, Borg rating of perceived exertion (BRPE) scale, beck depression inventory, forward head posture angle, rounded shoulder angle (RSA), shoulder slope angle, scapular downward rotation ratio, cervical lateral-bending side difference angle, cervical rotation side difference angle, glenohumeral internal rotation angle, shoulder horizontal adduction angle, serratus anterior (SA) strength, lower trapezius (LT) strength, bicep strength, and glenohumeral external rotator strength, in 163 FSWs with UT pain due to MTrPs.The model for factors influencing UT pain with MTrPs included SA strength, age, BRPE, LT strength, and RSA as predictor variables that accounted for 68.7% of the variance in VAS (P < .001) in multiple regression models with a stepwise selection procedure. The following were independent variables influencing the VAS in the order of standardized coefficients: SA strength (β = -0.380), age (β = 0.287), BRPE (β = 0.239), LT strength (β = -0.195), and RSA (β = 0.125).SA strength, age, BRPE, LT strength, and RSA variables should be considered when evaluating and intervening in UT pain with MTrPs in FSWs.

Predictors of upper trapezius pain with myofascial trigger points in food service workers

PubMed Central

Hwang, Ui-Jae; Kwon, Oh-Yun; Yi, Chung-Hwi; Jeon, Hye-Seon; Weon, Jong-Hyuck; Ha, Sung-Min

2017-01-01

Abstract Shoulder pain occurs commonly in food service workers (FSWs) who repetitively perform motions of the upper limbs. Myofascial trigger points (MTrPs) on the upper trapezius (UT) are among the most common musculoskeletal shoulder pain syndromes. This study determined the psychological, posture, mobility, and strength factors associated with pain severity in FSWs with UT pain due to MTrPs. In this cross-sectional study, we measured 17 variables in 163 FSWs with UT pain due to MTrPs: a visual analog scale (VAS) pain score, age, sex, Borg rating of perceived exertion (BRPE) scale, beck depression inventory, forward head posture angle, rounded shoulder angle (RSA), shoulder slope angle, scapular downward rotation ratio, cervical lateral-bending side difference angle, cervical rotation side difference angle, glenohumeral internal rotation angle, shoulder horizontal adduction angle, serratus anterior (SA) strength, lower trapezius (LT) strength, bicep strength, and glenohumeral external rotator strength, in 163 FSWs with UT pain due to MTrPs. The model for factors influencing UT pain with MTrPs included SA strength, age, BRPE, LT strength, and RSA as predictor variables that accounted for 68.7% of the variance in VAS (P < .001) in multiple regression models with a stepwise selection procedure. The following were independent variables influencing the VAS in the order of standardized coefficients: SA strength (β = −0.380), age (β = 0.287), BRPE (β = 0.239), LT strength (β = −0.195), and RSA (β = 0.125). SA strength, age, BRPE, LT strength, and RSA variables should be considered when evaluating and intervening in UT pain with MTrPs in FSWs. PMID:28658117

Can machine learning complement traditional medical device surveillance? A case study of dual-chamber implantable cardioverter-defibrillators.

PubMed

Ross, Joseph S; Bates, Jonathan; Parzynski, Craig S; Akar, Joseph G; Curtis, Jeptha P; Desai, Nihar R; Freeman, James V; Gamble, Ginger M; Kuntz, Richard; Li, Shu-Xia; Marinac-Dabic, Danica; Masoudi, Frederick A; Normand, Sharon-Lise T; Ranasinghe, Isuru; Shaw, Richard E; Krumholz, Harlan M

2017-01-01

Machine learning methods may complement traditional analytic methods for medical device surveillance. Using data from the National Cardiovascular Data Registry for implantable cardioverter-defibrillators (ICDs) linked to Medicare administrative claims for longitudinal follow-up, we applied three statistical approaches to safety-signal detection for commonly used dual-chamber ICDs that used two propensity score (PS) models: one specified by subject-matter experts (PS-SME), and the other one by machine learning-based selection (PS-ML). The first approach used PS-SME and cumulative incidence (time-to-event), the second approach used PS-SME and cumulative risk (Data Extraction and Longitudinal Trend Analysis [DELTA]), and the third approach used PS-ML and cumulative risk (embedded feature selection). Safety-signal surveillance was conducted for eleven dual-chamber ICD models implanted at least 2,000 times over 3 years. Between 2006 and 2010, there were 71,948 Medicare fee-for-service beneficiaries who received dual-chamber ICDs. Cumulative device-specific unadjusted 3-year event rates varied for three surveyed safety signals: death from any cause, 12.8%-20.9%; nonfatal ICD-related adverse events, 19.3%-26.3%; and death from any cause or nonfatal ICD-related adverse event, 27.1%-37.6%. Agreement among safety signals detected/not detected between the time-to-event and DELTA approaches was 90.9% (360 of 396, k =0.068), between the time-to-event and embedded feature-selection approaches was 91.7% (363 of 396, k =-0.028), and between the DELTA and embedded feature selection approaches was 88.1% (349 of 396, k =-0.042). Three statistical approaches, including one machine learning method, identified important safety signals, but without exact agreement. Ensemble methods may be needed to detect all safety signals for further evaluation during medical device surveillance.

Efficacy of infliximab on MRI-determined bone oedema in psoriatic arthritis.

PubMed

Marzo-Ortega, Helena; McGonagle, Dennis; Rhodes, Laura A; Tan, Ai Lyn; Conaghan, Philip G; O'Connor, Philip; Tanner, Steven F; Fraser, Alexander; Veale, Douglas; Emery, Paul

2007-06-01

Psoriatic arthritis (PsA) is commonly associated with bone pathology, including entheseal new bone formation and osteolysis. On MRI, areas of active clinical involvement are represented by bone oedema and synovitis. To assess the impact of infliximab on bone oedema in PsA as shown by MRI. 18 patients with joint swelling, psoriasis and seronegativity for rheumatoid factor received four infusions of infliximab, 3 mg/kg, in combination with methotrexate. MRI of the affected hand (12 patients) or knee joints (6 patients) was performed before and after treatment. The primary outcome was the assessment of bone oedema and synovitis at 20 weeks as shown by MRI. Secondary outcomes included the American College of Rheumatology (ACR) response criteria, psoriasis skin scores (Psoriasis Area and Severity Index (PASI)) and a quality of life measure (Psoriatic Arthritis Quality of Life (PsAQoL)). At baseline, bone oedema was seen in 50% of patients (seven hands and two knees) in 30% of scanned joints, and this improved or resolved in all cases in the hand joints (p = 0.018) and in one knee joint at 20 weeks. Synovitis was found to be reduced in 90% of cases on MRI. Likewise, a significant improvement in all clinical outcomes, including PASI (p = 0.003) and PsAQoL (p = 0.006) was seen at week 20. 65% (n = 11) of the patients achieved an ACR response, of whom 45% had ACR70 or above and 54% had ACR20 or ACR50. Infliximab treatment is associated with dramatic improvements in MRI-determined bone oedema in PsA in the short term. It remains to be determined whether infliiximib treatment is the cause for prevention of new bone formation, bone fusion or osteolysis in PsA as shown by radiography.

In-service documentation tools and statements on palliative sedation in Germany--do they meet the EAPC framework recommendations? A qualitative document analysis.

PubMed

Stiel, Stephanie; Heckel, Maria; Christensen, Britta; Ostgathe, Christoph; Klein, Carsten

2016-01-01

Numerous (inter-)national guidelines and frameworks have been developed to provide recommendations for the application of palliative sedation (PS). However, they are still not widely known, and large variations in PS clinical practice can be found. This study aims to collect and describe contents from documents used in clinical practice and to compare to what extent they match the European Association for Palliative Care (EAPC) framework recommendations. In a national survey on PS in Germany 2012, participants were asked to upload their in-service templates, assessment tools, specific protocols, and in-service statements for the application and documentation of PS. These documents are analyzed by using systematic structured content analysis. Three hundred seven content units of 52 provided documents were coded. The analyzed templates are very heterogeneous and also contain items not mentioned in the EAPC framework. Among 11 scales for the evaluation of sedation level, the Ramsey Sedation Score (n = 5) and the Richmond-Agitation-Sedation-Scale (n = 2) were found most often. For symptom assessment, three different scales were provided one time respectively. In all six PS statements, the common core elements were possible indications for PS, instructions on dose titration, patient monitoring, and care. Wide congruency exists for physical and psychological indications. Most documents coincide on midazolam as a preferred drug and basic monitoring in regular intervals. Aspects such as pre-emptive discussion of the potential role of sedation, informational needs of relatives, and care for the medical professionals are mentioned rarely. The analyzed templates do neglect some points of the EAPC recommendations. However, they expand the ten-point scheme of the framework in some details. The findings may facilitate the development of standardized consensus documentation and monitoring draft as an operational statement.

Musculoskeletal ultrasonography for psoriatic arthritis and psoriasis patients: a systematic literature review.

PubMed

Zabotti, Alen; Bandinelli, Francesca; Batticciotto, Alberto; Scirè, Carlo Alberto; Iagnocco, Annamaria; Sakellariou, Garifallia

2017-09-01

To systematically review the role of musculoskeletal US in patients suffering from PsA or psoriasis (Pso) in terms of prevalence, diagnosis, prognosis, monitoring and treatment. A systematic literature review was conducted through medical databases (MEDLINE via PubMed, Embase) and the grey literature up to September 2015 to inform a new study of the Musculoskeletal Ultrasound Study Group of the Italian Society for Rheumatology. All articles reporting data on musculoskeletal US in PsA or Pso were included and extracted according to the underlying clinical question. A total of 86 publications were included. The prevalence of US abnormalities showed a wide range for each examined feature (e.g. 37-95% for entheses thickness of the lower limbs). The performance of US for diagnosis of disease or elementary lesions was variable across studies, but no study evaluated the overall performance of US in addition to clinical findings for diagnosing PsA. Considering US in defining PsA and Pso prognosis, several works focused on US of entheses of lower limbs in Pso, while for the monitoring of PsA activity five different scoring systems were identified. Last, the results of the role of US in guiding intra-articular interventions were controversial for the clinical outcomes, but in favour of US for accuracy. despite the recognized importance of US in the management of PsA and Pso, this review clearly demonstrated the need of pivotal research in order to optimize the use of US in the diagnosis and monitoring of psoriatic disease. © The Author 2017. Published by Oxford University Press on behalf of the British Society for Rheumatology. All rights reserved. For Permissions, please email: journals.permissions@oup.com

The effect of phosphatidylserine on golf performance

PubMed Central

Jäger, Ralf; Purpura, Martin; Geiss, Kurt-Reiner; Weiß, Michael; Baumeister, Jochen; Amatulli, Francesco; Schröder, Lars; Herwegen, Holger

2007-01-01

Background A randomized, double-blind, placebo-controlled study was performed to evaluate the effect of oral phosphatidylserine (PS) supplementation on golf performance in healthy young golfers with handicaps of 15–40. Methods Perceived stress, heart rate and the quality of the ball flight was evaluated before (pre-test) and after (post-test) 42 days of 200 mg per day PS (n = 10) or placebo (n = 10) intake in the form of a nutritional bar. Subjects teed-off 20 times aiming at a green 135 meters from the tee area. Results PS supplementation significantly increased (p < 0.05) the number of good ball flights (mean: pre-test 8.3 ± 3.5, post-test 10.1 ± 3.0), whereas placebo intake (mean: pre-test 7.8 ± 2.4, post-test 7.9 ± 3.6) had no effect. PS supplementation showed a trend towards improving perceived stress levels during teeing-off (mean: pre-test 5.8 ± 2.0, post-test 4.0 ± 2.0, p = 0.07), whereas stress levels remained unchanged in the placebo group (mean: pre-test: 5.1 ± 2.0, post-test: 5.1 ± 3.1). Supplementation did not influence mean heart rate in either group. Conclusion It is concluded that six weeks of PS supplementation shows a statistically not significant tendency (p = 0.07) to improve perceived stress levels in golfers and significantly improves (p < 0.05) the number of good ball flights during tee-off which might result in improved golf scores. PMID:18053194

Evaluation of hair cortisol in beef cattle of divergent temperaments

USDA-ARS?s Scientific Manuscript database

The objective of this research project was to evaluate the relationships among hair and serum cortisol concentrations and cattle disposition. Spring born (n = 101) crossbred beef heifers (7 to 8 mo. of age) were evaluated for temperament preweaning and at weaning by pen score (PS; 1 = calm and 5 = e...

Financial Aid and College Persistence: Do Student Loans Help or Hurt?

ERIC Educational Resources Information Center

Herzog, Serge

2018-01-01

Using data from two freshmen cohorts at a public research university (N = 3730), this study examines the relationship between loan aid and second-year enrollment persistence. Applying a counterfactual analytical framework that relies on propensity score (PS) weighting and matching to address selection bias associated with treatment status, the…

Propensity score to detect baseline imbalance in cluster randomized trials: the role of the c-statistic.

PubMed

Leyrat, Clémence; Caille, Agnès; Foucher, Yohann; Giraudeau, Bruno

2016-01-22

Despite randomization, baseline imbalance and confounding bias may occur in cluster randomized trials (CRTs). Covariate imbalance may jeopardize the validity of statistical inferences if they occur on prognostic factors. Thus, the diagnosis of a such imbalance is essential to adjust statistical analysis if required. We developed a tool based on the c-statistic of the propensity score (PS) model to detect global baseline covariate imbalance in CRTs and assess the risk of confounding bias. We performed a simulation study to assess the performance of the proposed tool and applied this method to analyze the data from 2 published CRTs. The proposed method had good performance for large sample sizes (n =500 per arm) and when the number of unbalanced covariates was not too small as compared with the total number of baseline covariates (≥40% of unbalanced covariates). We also provide a strategy for pre selection of the covariates needed to be included in the PS model to enhance imbalance detection. The proposed tool could be useful in deciding whether covariate adjustment is required before performing statistical analyses of CRTs.

Effectiveness of Personalized Feedback Alone or Combined with Peer Support to Improve Physical Activity in Sedentary Older Malays with Type 2 Diabetes: A Randomized Controlled Trial.

PubMed

Sazlina, Shariff-Ghazali; Browning, Colette Joy; Yasin, Shajahan

2015-01-01

Regular physical activity is an important aspect of self-management among older people with type 2 diabetes but many remain inactive. Interventions to improve physical activity levels have been studied but few studies have evaluated the effects of personalized feedback (PF) or peer support (PS); and there was no study on older people of Asian heritage. Hence, this trial evaluated whether PF only or combined with PS improves physical activity among older Malays with type 2 diabetes (T2DM) compared to usual care only. A three-arm randomized controlled trial was conducted in a primary healthcare clinic in Malaysia. Sixty-nine sedentary Malays aged 60 years and older with T2DM who received usual diabetes care were randomized to PF or PS interventions or as controls for 12 weeks with follow-ups at weeks 24 and 36. Intervention groups performed unsupervised walking activity and received written feedback on physical activity. The PS group also received group and telephone contacts from trained peer mentors. The primary outcome was pedometer steps. Secondary outcomes were self-reported physical activity, cardiovascular risk factors, cardiorespiratory fitness, balance, quality of life, and psychosocial wellbeing. Fifty-two (75.4%) completed the 36-week study. The PS group showed greater daily pedometer readings than the PF and controls (p = 0.001). The PS group also had greater improvement in weekly duration (p < 0.001) and frequency (p < 0.001) of moderate intensity physical activity, scores on the Physical Activity Scale for Elderly (p = 0.003), 6-min walk test (p < 0.001), and social support from friends (p = 0.032) than PF and control groups. The findings suggest that PF combined with PS in older Malays with T2DM improved their physical activity levels, cardiorespiratory fitness, and support from friends. Current Controlled Trials ISRCTN71447000.

Implementation of protocolized tight control and biological dose optimization in daily clinical practice: results of a pilot study.

PubMed

Lesuis, N; Verhoef, L M; Nieboer, L M; Bruyn, G A; Baudoin, P; van Vollenhoven, R F; Hulscher, Mejl; van den Hoogen, Fhj; den Broeder, A A

2017-03-01

To assess the effects of education, guideline development, and individualized treatment advice on rheumatologist adherence to tight control-based treatment and biological dose optimization in rheumatoid arthritis (RA), psoriatic arthritis (PsA), and spondyloarthropathy (SpA) patients. This pilot study, among two rheumatologists and two specialized nurses in a general hospital, combined education, feedback, local guideline development, and individualized treatment advice. Outcomes (baseline and 1 year post-intervention) were the percentage of patients with a Disease Activity Score in 28 joints (DAS28) or Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) measured during the visit, mean DAS28/BASDAI, and the percentage of patients using a reduced biological dose. DAS28 outcomes only applied to RA and PsA patients, BASDAI outcomes only applied to SpA patients whereas outcomes on biological dose applied to all patients. A total of 232 patients (67% RA, 15% PsA, 18% SpA; 58% female, mean age 56 ± 15 years) were included in the study. The percentage of DAS28 and BASDAI measurements performed increased after the intervention [DAS28 15-51%, odds ratio (OR) 3.3, 95% confidence interval (CI) 2.1-5.5; BASDAI 23-50%, OR 2.2, 95% CI 1.0-5.5], with mean DAS28 and BASDAI scores remaining similar (DAS28: mean difference 0.1, 95% CI -0.3 to 0.5; BASDAI: mean difference 0.03, 95% CI -1.8 to 1.9). Use of a reduced biological dose increased from 10% to 61% (OR 3.9, 95% CI 2.4-6.5). A multicomponent intervention strategy aimed at rheumatologists can lead to improved adherence to tight control-based treatment and a reduction in the use of biologicals in RA, SpA, and PsA patients.

A measure of fall risk behaviors and perceptions among community-dwelling older adults.

PubMed

Yuen, Hon Keung; Carter, Rickey E

2006-01-01

Relatively little is known about the interaction between behavioral and environmental circumstances associated with falls among community-dwelling older adults. This study is designed to develop an instrument that measures community-dwelling older adults' participation in and perceptions of fall risk behaviors. Eighty-seven community-dwelling older adults aged 60 or above (mean +/- SD = 76 +/- 7.9), who had experienced at least one fall in the past 12 months, completed a questionnaire dealing with frequency of their participation in fall risk behaviors, their perceptions of these behaviors, and their fall history. Data were subjected to exploratory factor analysis. A 20-item instrument consisting of three constructs was presented as the Fall Risk Behaviors and Perceptions Scale (FRB&PS). Two of the three constructs of the instrument were de-stabilizers and non-supports, both of which measure participation in fall risk behaviors; the third was perceptions of fall risk behaviors. Internal consistency coefficient of the FRB&PS is 0.733 with a root mean square error of approximation (RMSEA) score of 0.075, which indicates an adequate model fit. Results from the stepwise regression analyses indicated that adults aged 75 and above (the old-old) participated less frequently in fall risk activities (p = 0.025), and had more knowledge about fall risks as measured by a higher perception score (p = 0.025) than those aged 60 to 75 (the young-old). Older men tended to participate more frequently in fall risk activities (p = 0.020) than older women; in addition, those older adults who are more mobile (p = 0.002) also participated more frequently in fall risk behaviors than those who are less mobile. Preliminary findings indicate that the pilot FRB&PS is a reliable and valid instrument to measure community-dwelling older adults' participation in and perceptions of fall risk behaviors. Additional psychometric validation of the FRB&PS on predicting the likelihood of falls is warranted.

PGY-1 surgery preparatory course design: identification of key curricular components.

PubMed

Antonoff, Mara B; D'Cunha, Jonathan

2011-01-01

The importance of preparing senior medical students (SMS) for surgical internship is clear, and initiatives to standardize such curricula are of national interest. Less clear, however, are the specific subject areas most important for inclusion in such courses. In this study, we aimed to identify key curricular components in the development of a PGY-1 Surgery Preparatory Course. A month-long PGY-1 preparatory course was offered to SMS entering surgical residencies, consisting of 55 sessions providing instruction in 3 main areas: 19 Ward Management Tasks (WMT), 12 Operative and Technical Skills (OTS), and 4 Professionalism Skillsets (PS). To determine curricular topics most valued and needed by students, data were reviewed from precourse and postcourse surveys, knowledge tests, and performance examinations. Pretest/posttest scores were compared using t-tests, α = 0.05. In all, 22 SMS enrolled in the course. Prior to course participation, students placed greatest importance on WMT (4.35 ± 0.05) over OTS (4.09 ± 0.06) and PS (3.90 ± 0.15), p < 0.05. Precourse confidence levels were lowest in WMT (2.28 ± 0.12), versus OTS (2.41 ± 0.20) and PS (3.50 ± 0.30). Mean pretest scores were 54.8 ± 2.1% in WMT and 82.7 ± 2.5% in OTS, with significant improvement to 82.2 ± 1.9% and 93.2 ± 1.3%, respectively (p < 0.05 for both), further showing greater need for instruction in WMT. SMS participating in a PGY-1 Surgery Preparatory Course identified WMT as more important than OTS and PS. Further, they demonstrated the lowest precourse confidence in this area and found that course participation most dramatically improved their perceived ability to execute these types of tasks. As efforts continue to formalize the transition from medical school to surgical residency, these findings will be instrumental in developing standardized curricula. Copyright © 2011 Association of Program Directors in Surgery. Published by Elsevier Inc. All rights reserved.

Association between the Part D coverage gap and adverse health outcomes.

PubMed

Polinski, Jennifer M; Shrank, William H; Glynn, Robert J; Huskamp, Haiden A; Christopher Roebuck, M; Schneeweiss, Sebastian

2012-08-01

To determine whether Part D coverage gap entry is associated with risk of death or hospitalization for cardiovascular outcomes. Prospective cohort study. Beneficiaries entered the study upon reaching the coverage gap spending threshold and were observed until an outcome reaching the threshold for catastrophic coverage occurred or year's end. Nine thousand four hundred thirty-six exposed individuals (those who were responsible for drug costs in the gap) were compared with 9,436 unexposed individuals (those who received financial assistance) based on propensity score (PS) or high-dimensional propensity score (hdPS). Medicare Part D drug insurance. Three hundred three thousand nine hundred seventy-eight Medicare beneficiaries aged 65 and older in 2006 and 2007 with linked prescription and medical claims who enrolled in stand-alone Part D or retiree drug plans and reached the gap spending threshold. Rates of death and hospitalization for any of five cardiovascular outcomes, including acute coronary syndrome with revascularization (ACS), after reaching the coverage gap spending threshold were compared using Cox proportional hazards models. In PS-matched analyses, exposed beneficiaries had higher, albeit not significantly so, hazard of death (hazard ratio (HR) = 1.25, 95% confidence interval (CI) = 0.98-1.59) and ACS (HR = 1.16, 95% CI = 0.83-1.62) than unexposed beneficiaries. hdPS-matched analyses minimized residual confounding and confirmed results (death: HR = 0.99, 95% CI = 0.78-1.24; ACS: HR = 1.07, 95% CI = 0.81-1.41). Exposed beneficiaries were no more or less likely to experience other outcomes than were those who were unexposed. During the short-term coverage gap period, having no financial assistance to pay for drugs was not associated with greater risk of death or hospitalization for cardiovascular causes, although long-term health consequences remain unclear. © 2012, Copyright the Authors Journal compilation © 2012, The American Geriatrics Society.

Do depression and anxiety reduce the likelihood of remission in rheumatoid arthritis and psoriatic arthritis? Data from the prospective multicentre NOR-DMARD study.

PubMed

Michelsen, Brigitte; Kristianslund, Eirik Klami; Sexton, Joseph; Hammer, Hilde Berner; Fagerli, Karen Minde; Lie, Elisabeth; Wierød, Ada; Kalstad, Synøve; Rødevand, Erik; Krøll, Frode; Haugeberg, Glenn; Kvien, Tore K

2017-11-01

To investigate the predictive value of baseline depression/anxiety on the likelihood of achieving joint remission in rheumatoid arthritis (RA) and psoriatic arthritis (PsA) as well as the associations between baseline depression/anxiety and the components of the remission criteria at follow-up. We included 1326 patients with RA and 728 patients with PsA from the prospective observational NOR-DMARD study starting first-time tumour necrosis factor inhibitors or methotrexate. The predictive value of depression/anxiety on remission was explored in prespecified logistic regression models and the associations between baseline depression/anxiety and the components of the remission criteria in prespecified multiple linear regression models. Baseline depression/anxiety according to EuroQoL-5D-3L, Short Form-36 (SF-36) Mental Health subscale ≤56 and SF-36 Mental Component Summary ≤38 negatively predicted 28-joint Disease Activity Score <2.6, Simplified Disease Activity Index ≤3.3, Clinical Disease Activity Index ≤2.8, ACR/EULAR Boolean and Disease Activity Index for Psoriatic Arthritis ≤4 remission after 3 and 6 months treatment in RA (p≤0.008) and partly in PsA (p from 0.001 to 0.73). Baseline depression/anxiety was associated with increased patient's and evaluator's global assessment, tender joint count and joint pain in RA at follow-up, but not with swollen joint count and acute phase reactants. Depression and anxiety may reduce likelihood of joint remission based on composite scores in RA and PsA and should be taken into account in individual patients when making a shared decision on a treatment target. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Significance of clinical evaluation of the metacarpophalangeal joint in relation to synovial/bone pathology in rheumatoid and psoriatic arthritis detected by magnetic resonance imaging.

PubMed

Stone, Millicent A; White, Lawrence M; Gladman, Dafna D; Inman, Robert D; Chaya, Sam; Lax, Matthew; Salonen, David; Weber, Deborah A; Guthrie, Judy A; Pomeroy, Emma; Podbielski, Dominik; Keystone, Edward C

2009-12-01

Rheumatologists base many clinical decisions regarding the management of inflammatory joint diseases on joint counts performed at clinic. We investigated the reliability and accuracy of physically examining the metacarpophalangeal (MCP) joints to detect inflammatory synovitis using magnetic resonance imaging (MRI) as the gold standard. MCP joints 2 to 5 in both hands of 5 patients with rheumatoid arthritis (RA) and 5 with psoriatic arthritis (PsA) were assessed by 5 independent examiners for joint-line swelling (visually and by palpation); joint-line tenderness by palpation (tender joint count, TJC) and stress pain; and by MRI (1.5 Tesla superconducting magnet). Interrater reliability was assessed using kappa statistics, and agreement between examination and corresponding MRI assessment was assessed by Fisher's exact tests (p < 0.05 considered statistically significant). Interrater agreement was highest for visual assessment of swelling (kappa = 0.55-0.63), slight-fair for assessment of swelling by palpation (kappa = 0.19-0.41), and moderate (kappa = 0.41-0.58) for assessment of joint tenderness. In patients with RA, TJC, stress pain, and visual swelling assessment were strongly associated with MRI evaluation of synovitis. Visual swelling assessment demonstrated high specificity (> 0.8) and positive predictive value (= 0.8). For PsA, significant associations exist between TJC and MRI synovitis scores (p < 0.01) and stress pain and MRI edema scores (p < 0.04). Assessment of swelling by palpation was not significantly associated with synovitis or edema as determined by MRI in RA or PsA (p = 0.54-1.0). In inflammatory arthritis, disease activity in MCP joints can be reliably assessed at the bedside by examining for joint-line tenderness (TJC) and visual inspection for swelling. Clinical assessment may have to be complemented by other methods for evaluating disease activity in the joint, such as MRI, particularly in patients with PsA.

Improved P300 speller performance using electrocorticography, spectral features, and natural language processing.

PubMed

Speier, William; Fried, Itzhak; Pouratian, Nader

2013-07-01

The P300 speller is a system designed to restore communication to patients with advanced neuromuscular disorders. This study was designed to explore the potential improvement from using electrocorticography (ECoG) compared to the more traditional usage of electroencephalography (EEG). We tested the P300 speller on two epilepsy patients with temporary subdural electrode arrays over the occipital and temporal lobes respectively. We then performed offline analysis to determine the accuracy and bit rate of the system and integrated spectral features into the classifier and used a natural language processing (NLP) algorithm to further improve the results. The subject with the occipital grid achieved an accuracy of 82.77% and a bit rate of 41.02, which improved to 96.31% and 49.47 respectively using a language model and spectral features. The temporal grid patient achieved an accuracy of 59.03% and a bit rate of 18.26 with an improvement to 75.81% and 27.05 respectively using a language model and spectral features. Spatial analysis of the individual electrodes showed best performance using signals generated and recorded near the occipital pole. Using ECoG and integrating language information and spectral features can improve the bit rate of a P300 speller system. This improvement is sensitive to the electrode placement and likely depends on visually evoked potentials. This study shows that there can be an improvement in BCI performance when using ECoG, but that it is sensitive to the electrode location. Copyright © 2013 International Federation of Clinical Neurophysiology. Published by Elsevier Ireland Ltd. All rights reserved.

Flexible inorganic light emitting diodes and transparent PEDOT:PSS/Parylene C for simultaneous optogenetics and electrocorticography (Conference Presentation)

NASA Astrophysics Data System (ADS)

Lee, Keundong; Ganji, Mehran; Hossain, Lorraine; Ro, Yun Goo; Lee, Sang Heon; Park, Jong-woo; Yoo, Dongha; Yoon, Jiyoung; Yi, Gyu-Chul; Dayeh, Shadi A.

2017-02-01

Electrocorticography (ECoG) is a powerful tool for direct mapping of local field potentials from the brain surface. Progress in development of high-fidelity materials such as poly(3,4-ethylenedioxythiophene):poly(styrenesulfonate) (PEDOT:PSS) on thin conformal substrates such as parylene C enabled intimate contact with cortical surfaces and higher quality recordings from small volumes of neurons. Meanwhile, stimulation of neuronal activity is conventionally accomplished with electrical microstimulation and transcranial magnetic stimulation that can be combined with ECoG to form the basis of bidirectional neural interface. However, these stimulation mechanisms are less controlled and primitively understood on the local and cellular levels. With the advent of optogenetics, the localization and specificity of neuronal stimulation and inhibition is possible. Therefore, the development of integrated devices that can merge the sensitivity of ECoG or depth recording with optogenetic tools can lead to newer frontiers in understanding the neuronal activity. Herein, we introduce a hybrid device comprising flexible inorganic LED arrays integrated PEDOT:PSS/parylene C microelectrode arrays for high resolution bidirectional neuronal interfaces. The flexible inorganic LEDs have been developed by the metal-organic vapor phase epitaxy of position-controlled GaN microLEDs on ZnO nanostructured templates pre-grown at precise locations on a graphene layer. By transferring it onto the microelectrode arrays, it can provides the individual electrical addressability by light stimulation patterns. We will present experimental and simulation results on the optoelectronic characteristics and light activation capability of flexible microLEDs and their evaluation in vivo.

Decoding Speech With Integrated Hybrid Signals Recorded From the Human Ventral Motor Cortex.

PubMed

Ibayashi, Kenji; Kunii, Naoto; Matsuo, Takeshi; Ishishita, Yohei; Shimada, Seijiro; Kawai, Kensuke; Saito, Nobuhito

2018-01-01

Restoration of speech communication for locked-in patients by means of brain computer interfaces (BCIs) is currently an important area of active research. Among the neural signals obtained from intracranial recordings, single/multi-unit activity (SUA/MUA), local field potential (LFP), and electrocorticography (ECoG) are good candidates for an input signal for BCIs. However, the question of which signal or which combination of the three signal modalities is best suited for decoding speech production remains unverified. In order to record SUA, LFP, and ECoG simultaneously from a highly localized area of human ventral sensorimotor cortex (vSMC), we fabricated an electrode the size of which was 7 by 13 mm containing sparsely arranged microneedle and conventional macro contacts. We determined which signal modality is the most capable of decoding speech production, and tested if the combination of these signals could improve the decoding accuracy of spoken phonemes. Feature vectors were constructed from spike frequency obtained from SUAs and event-related spectral perturbation derived from ECoG and LFP signals, then input to the decoder. The results showed that the decoding accuracy for five spoken vowels was highest when features from multiple signals were combined and optimized for each subject, and reached 59% when averaged across all six subjects. This result suggests that multi-scale signals convey complementary information for speech articulation. The current study demonstrated that simultaneous recording of multi-scale neuronal activities could raise decoding accuracy even though the recording area is limited to a small portion of cortex, which is advantageous for future implementation of speech-assisting BCIs.

Decoding Speech With Integrated Hybrid Signals Recorded From the Human Ventral Motor Cortex

PubMed Central

Ibayashi, Kenji; Kunii, Naoto; Matsuo, Takeshi; Ishishita, Yohei; Shimada, Seijiro; Kawai, Kensuke; Saito, Nobuhito

2018-01-01

Restoration of speech communication for locked-in patients by means of brain computer interfaces (BCIs) is currently an important area of active research. Among the neural signals obtained from intracranial recordings, single/multi-unit activity (SUA/MUA), local field potential (LFP), and electrocorticography (ECoG) are good candidates for an input signal for BCIs. However, the question of which signal or which combination of the three signal modalities is best suited for decoding speech production remains unverified. In order to record SUA, LFP, and ECoG simultaneously from a highly localized area of human ventral sensorimotor cortex (vSMC), we fabricated an electrode the size of which was 7 by 13 mm containing sparsely arranged microneedle and conventional macro contacts. We determined which signal modality is the most capable of decoding speech production, and tested if the combination of these signals could improve the decoding accuracy of spoken phonemes. Feature vectors were constructed from spike frequency obtained from SUAs and event-related spectral perturbation derived from ECoG and LFP signals, then input to the decoder. The results showed that the decoding accuracy for five spoken vowels was highest when features from multiple signals were combined and optimized for each subject, and reached 59% when averaged across all six subjects. This result suggests that multi-scale signals convey complementary information for speech articulation. The current study demonstrated that simultaneous recording of multi-scale neuronal activities could raise decoding accuracy even though the recording area is limited to a small portion of cortex, which is advantageous for future implementation of speech-assisting BCIs. PMID:29674950

Mapping working memory retrieval in space and in time: A combined electroencephalography and electrocorticography approach.

PubMed

Zhang, Qiong; van Vugt, Marieke; Borst, Jelmer P; Anderson, John R

2018-07-01

In this study, we investigated the time course and neural correlates of the retrieval process underlying visual working memory. We made use of a rare dataset in which the same task was recorded using both scalp electroencephalography (EEG) and Electrocorticography (ECoG), respectively. This allowed us to examine with great spatial and temporal detail how the retrieval process works, and in particular how the medial temporal lobe (MTL) is involved. In each trial, participants judged whether a probe face had been among a set of recently studied faces. With a method that combines hidden semi-Markov models and multivariate pattern analysis, the neural signal was decomposed into a sequence of latent cognitive stages with information about their durations on a trial-by-trial basis. Analyzed separately, EEG and ECoG data yielded converging results on discovered stages and their interpretation, which reflected 1) a brief pre-attention stage, 2) encoding the stimulus, 3) retrieving the studied set, and 4) making a decision. Combining these stages with the high spatial resolution of ECoG suggested that activity in the temporal cortex reflected item familiarity in the retrieval stage; and that once retrieval is complete, there is active maintenance of the studied face set in the decision stage in the MTL. During this same period, the frontal cortex guides the decision by means of theta coupling with the MTL. These observations generalize previous findings on the role of MTL theta from long-term memory tasks to short-term memory tasks. Copyright © 2018 Elsevier Inc. All rights reserved.

Childhood chronic conditions and health-related quality of life: Findings from a large population-based study

PubMed Central

Bai, Guannan; Herten, Marieke Houben–van; Landgraf, Jeanne M.; Korfage, Ida J.

2017-01-01

The objective of this study was to assess the impact of health-related quality of life (HRQOL) across prevalent chronic conditions, individually and comorbid, in school-aged children in the Netherlands. 5301 children aged 4–11 years from the Dutch Health Interview Survey were included. Parents completed questionnaires regarding child and parental characteristics. HRQOL of children was measured using the Child Health Questionnaire Parent Form 28 (CHQ-PF28). Independent-t tests were used to assess differences in the mean scores of the CHQ-PF28 summary scales and profile scales between children with a prevalent chronic condition (excluding or including children with multiple chronic conditions) and children without a chronic condition. Cohen’s effect sizes (d) were calculated to assess the clinical significance of difference. The mean age of children was 7.55 (SD 2.30) years; 50.0% were boys. In children without any chronic condition, the mean score of physical summary scale (PhS) was 58.53 (SD 4.28) and mean score of the psychosocial summary scale (PsS) was 53.86 (SD 5.87). Generally, PhS and/or PsS scores in children with only one condition were lower (p<0.05) than for children without chronic conditions. When children with multiple conditions were included, mean scores of CHQ-PF28 summary and profile scales were generally lower than when they were excluded. The present study shows important information regarding the impact of prevalent chronic conditions on HRQOL in a representative population-based sample of school-aged children in the Netherlands. The information could be used for developing a more holistic approach to patient care and a surveillance framework for health promotion. PMID:28575026

Utility of the CPS+EG staging system in hormone receptor-positive, human epidermal growth factor receptor 2-negative breast cancer treated with neoadjuvant chemotherapy.

PubMed

Marmé, Frederik; Lederer, Bianca; Blohmer, Jens-Uwe; Costa, Serban Dan; Denkert, Carsten; Eidtmann, Holger; Gerber, Bernd; Hanusch, Claus; Hilfrich, Jörn; Huober, Jens; Jackisch, Christian; Kümmel, Sherko; Loibl, Sibylle; Paepke, Stefan; Untch, Michael; von Minckwitz, Gunter; Schneeweiss, Andreas

2016-01-01

Pathologic complete response after neoadjuvant chemotherapy (NACT) correlates with overall survival (OS) in primary breast cancer. A recently described staging system based on pre-treatment clinical stage (CS), final pathological stage (PS), estrogen receptor (ER) status and nuclear grade (NG) leads to a refined estimation of prognosis in unselected patients. Its performance in luminal type breast cancers has not been determined. This study investigates the clinical utility of this CPS+EG score when restricted to hormone receptor-positive (HR+)/human epidermal growth factor receptor 2-negative (HER2-) patients and compares the results to a cohort of unselected patients. The CPS+EG score was calculated for 6637 unselected patients and 2454 patients with HR+/HER2- tumours who received anthracycline/taxane-based NACT within 8 prospective German trials. Five-year disease-free survival (DFS) and OS were 75.6% and 84.1% for the unselected cohort and 80.6% and 87.8% for the HR+/HER2- subgroup, respectively. The CPS+EG system distinguished different prognostic groups with 5-year DFS ranging from 0% to 91%. The CPS+EG system leads to an improved categorisation of patients by outcome compared to CS, PS, ER or NG alone. When applying the CPS+EG score to the HR+/HER2- subgroup, a shift to lower scores was observed compared to the overall population, but 5-year DFS and OS for the individual scores were identical to that observed in the overall population. In HR+/HER2- patients, the CPS+EG staging system retains its ability to facilitate a refined stratification of patients according to outcome. It can help to select candidates for post-neoadjuvant clinical trials in luminal breast cancer. Copyright © 2015 Elsevier Ltd. All rights reserved.

Pain and recovery after total knee arthroplasty: a 12-month follow-up after a prospective randomized study evaluating Nefopam and Ketamine for early rehabilitation.

PubMed

Aveline, Christophe; Roux, Alain Le; Hetet, Hubert Le; Gautier, Jean F; Vautier, Pierre; Cognet, Fabrice; Bonnet, Francis

2014-09-01

Ketamine and nefopam has been documented to decrease pain intensity and improve rehabilitation after total knee arthroplasty (TKA). We conducted a follow-up study of a previously randomized clinical trial to determine the prevalence and risk factors of chronic pain 1 year after TKA and to assess the role of perioperative administration of ketamine and nefopam. The original randomized, double-blind trial evaluated postoperative pain in 75 patients scheduled for TKA who received either a 48-hour infusion of ketamine or nefopam compared with placebo. The current study has evaluated patients at 6 and 12 months for the presence of chronic pain defined as a visual analogue scale ≥40 mm during a stair-climbing test. Other outcomes were incidence of neuropathic pain evaluated (DN4 score), active flexion of the knee, and functional outcome (KOOS-PS score). A total of 69 patients completed the trial. The prevalence of chronic pain at 12 months was 17.4% (95% confidence interval [CI], 10.2%-27.9%) without difference between the ketamine (12.5%), nefopam (13.7%), and placebo groups (26.1%). Prevalence of neuropathic pain was 10.2% (95% CI, 3%-17.3%). Ketamine reduced DN4 scores (P=0.02), increased knee flexion (P=0.0007), and KOOS-PS scores (P<0.0001) compared with placebo. A visual analogue scale score ≥60 mm in the postoperative period was the only risk factor associated with the occurrence of chronic pain (odds ratio 4.54; 95% CI, 1.17-17.67). After TKA, the intensity of postoperative pain is a risk factor of chronic pain on movement. Intraoperative ketamine seems to improve long-term results of rehabilitation in this setting.

Short-term change in physical function and disability: the Women's Health and Aging Study.

PubMed

Mendes de Leon, Carlos F; Guralnik, Jack M; Bandeen-Roche, Karen

2002-11-01

Although measures of physical function are predictive of future disability, little is known about the short-term impact of changes in physical function on disability. Data from 93 of the 102 women who participated in the Weekly Substudy of the Women's Health and Aging Study (WHAS) were used to explore the association of changes in physical function with disability. The WHAS Substudy included 24 weekly assessments of three standard performance tests and self-reported disability in activities of daily living (ADLs) and basic mobility. Using random-effects models, we found small but significant (ps <.01) changes in ADL and mobility disability during weekly follow-up. Baseline performance scores were significantly associated with both ADL and mobility disability (ps <.001), accounting for 27% and 36% of the between-person variability in each type of disability, respectively. After adjustment for baseline scores, change in performance scores was significantly associated with ADL disability (beta = 0.08, p <.01) and mobility disability (beta = 0.12, p <.001), but accounted only for a small proportion (<10%) of the variability in the rate of change in disability outcomes. There was no evidence for an additional effect on either type of disability because of having a single episode of a higher or lower than usual performance score, or because of periods of at least 4 consecutive higher or lower than usual performance test scores. Basic physical functions account for a substantial proportion of the heterogeneity in ADL and mobility disability among older disabled women, but have a relatively small impact on short-term changes in either type of disability. Effective prevention of disability may require attention to a wider array of risk factors than just limitations in basic physical functions.

Oropharyngeal Dysphagia in patients with obstructive sleep apnea syndrome.

PubMed

Schindler, Antonio; Mozzanica, Francesco; Sonzini, Giulia; Plebani, Daniela; Urbani, Emanuele; Pecis, Marica; Montano, Nicola

2014-02-01

Although previous studies demonstrated that patients with obstructive sleep apnea syndrome (OSAS) may present subclinical manifestations of dysphagia, in not one were different textures and volumes systematically studied. The aim of this study was to analyze the signs and symptoms of oropharyngeal dysphagia using fiberoptic endoscopic evaluation of swallowing (FEES) with boluses of different textures and volumes in a large cohort of patients with OSAS. A total of 72 OSAS patients without symptoms of dysphagia were enrolled. The cohort was divided in two groups: 30 patients with moderate OSAS and 42 patients with severe OSAS. Each patient underwent a FEES examination using 5, 10 and 20 ml of liquids and semisolids, and solids. Spillage, penetration, aspiration, retention, and piecemeal deglutition were considered. The penetration-aspiration scale (PAS), pooling score (PS), and dysphagia outcome and severity scale (DOSS) were used for quantitative analysis. Each patient completed the SWAL-QOL questionnaire. Forty-six patients (64 %) presented spillage, 20 (28 %) piecemeal deglutition, 26 (36 %) penetration, and 30 (44 %) retention. No differences were found in the PAS, PS, and DOSS scores between patients with moderate and severe OSAS. Patients with severe OSAS scored higher General Burden and Food selection subscales of the SWAL-QOL. Depending on the DOSS score, the cohort of patients was divided into those with and those without signs of dysphagia. Patients with signs of dysphagia scored lower in the General Burden and Symptoms subscales of the SWAL-QOL. OSAS patients show signs of swallowing impairment in about half of the population; clinicians involved in the management of these patients should include questions on swallowing when taking the medical history.

Likelihood-based methods for evaluating principal surrogacy in augmented vaccine trials.

PubMed

Liu, Wei; Zhang, Bo; Zhang, Hui; Zhang, Zhiwei

2017-04-01

There is growing interest in assessing immune biomarkers, which are quick to measure and potentially predictive of long-term efficacy, as surrogate endpoints in randomized, placebo-controlled vaccine trials. This can be done under a principal stratification approach, with principal strata defined using a subject's potential immune responses to vaccine and placebo (the latter may be assumed to be zero). In this context, principal surrogacy refers to the extent to which vaccine efficacy varies across principal strata. Because a placebo recipient's potential immune response to vaccine is unobserved in a standard vaccine trial, augmented vaccine trials have been proposed to produce the information needed to evaluate principal surrogacy. This article reviews existing methods based on an estimated likelihood and a pseudo-score (PS) and proposes two new methods based on a semiparametric likelihood (SL) and a pseudo-likelihood (PL), for analyzing augmented vaccine trials. Unlike the PS method, the SL method does not require a model for missingness, which can be advantageous when immune response data are missing by happenstance. The SL method is shown to be asymptotically efficient, and it performs similarly to the PS and PL methods in simulation experiments. The PL method appears to have a computational advantage over the PS and SL methods.

How to establish causality in epilepsy surgery.

PubMed

Asano, Eishi; Brown, Erik C; Juhász, Csaba

2013-09-01

Focality in electro-clinical or neuroimaging data often motivates epileptologists to consider epilepsy surgery in patients with medically-uncontrolled seizures, while not all focal findings are causally associated with the generation of epileptic seizures. With the help of Hill's criteria, we have discussed how to establish causality in the context of the presurgical evaluation of epilepsy. The strengths of EEG include the ability to determine the temporal relationship between cerebral activities and clinical events; thus, scalp video-EEG is necessary in the evaluation of the majority of surgical candidates. The presence of associated ictal discharges can confirm the epileptic nature of a particular spell and whether an observed neuroimaging abnormality is causally associated with the epileptic seizure. Conversely, one should be aware that scalp EEG has a limited spatial resolution and sometimes exhibits propagated epileptiform discharges more predominantly than in situ discharges generated at the seizure-onset zone. Intraoperative or extraoperative electrocorticography (ECoG) is utilized when noninvasive presurgical evaluation, including anatomical and functional neuroimaging, fails to determine the margin between the presumed epileptogenic zone and eloquent cortex. Retrospective as well as prospective studies have reported that complete resection of the seizure-onset zone on ECoG was associated with a better seizure outcome, but not all patients became seizure-free following such resective surgery. Some retrospective studies suggested that resection of sites showing high-frequency oscillations (HFOs) at >80Hz on interictal or ictal ECoG was associated with a better seizure outcome. Others reported that functionally-important areas may generate HFOs of a physiological nature during rest as well as sensorimotor and cognitive tasks. Resection of sites showing task-related augmentation of HFOs has been reported to indeed result in functional loss following surgery. Thus, some but not all sites showing interictal HFOs are causally associated with seizure generation. Furthermore, evidence suggests that some task-related HFOs can be transiently suppressed by the prior occurrence of interictal spikes. The significance of interictal HFOs should be assessed by taking into account the eloquent cortex, seizure-onset zone, and cortical lesions. Video-EEG and ECoG generally provide useful but still limited information to establish causality in presurgical evaluation. A comprehensive assessment of data derived from multiple modalities is ultimately required for successful management. Copyright © 2013 The Japanese Society of Child Neurology. Published by Elsevier B.V. All rights reserved.

How to establish causality in epilepsy surgery

PubMed Central

Asano, Eishi; Brown, Erik C; Juhász, Csaba

2013-01-01

Focality in electro-clinical or neuroimaging data often motivates epileptologists to consider epilepsy surgery in patients with medically-uncontrolled seizures, while not all focal findings are causally associated with the generation of epileptic seizures. With the help of Hill's criteria, we have discussed how to establish causality in the context of the presurgical evaluation of epilepsy. The strengths of EEG include the ability to determine the temporal relationship between cerebral activities and clinical events; thus, scalp video-EEG is necessary in the evaluation of the majority of surgical candidates. The presence of associated ictal discharges can confirm the epileptic nature of a particular spell and whether an observed neuroimaging abnormality is causally associated with the epileptic seizure. Conversely, one should be aware that scalp EEG has a limited spatial resolution and sometimes exhibits propagated epileptiform discharges more predominantly than in situ discharges generated at the seizure-onset zone. Intraoperative or extraoperative electrocorticography (ECoG) is utilized when noninvasive presurgical evaluation, including anatomical and functional neuroimaging, fails to determine the margin between the presumed epileptogenic zone and eloquent cortex. Retrospective as well as prospective studies have reported that complete resection of the seizure-onset zone on ECoG was associated with a better seizure outcome, but not all patients became seizure-free following such resective surgery. Some retrospective studies suggested that resection of sites showing high-frequency oscillations (HFOs) at >80 Hz on interictal or ictal ECoG was associated with a better seizure outcome. Others reported that functionally-important areas may generate HFOs of a physiological nature during rest as well as sensorimotor and cognitive tasks. Resection of sites showing task-related augmentation of HFOs has been reported to indeed result in functional loss following surgery. Thus, some but not all sites showing interictal HFOs are causally associated with seizure generation. Furthermore, evidence suggests that some task-related HFOs can be transiently suppressed by the prior occurrence of interictal spikes. The significance of interictal HFOs should be assessed by taking into account the eloquent cortex, seizure-onset zone, and cortical lesions. Video-EEG and ECoG generally provide useful but still limited information to establish causality in presurgical evaluation. A comprehensive assessment of data derived from multiple modalities is ultimately required for successful management. PMID:23684007

Comorbidity and economic burden among moderate-to-severe psoriasis and/or psoriatic arthritis patients in the US Department of Defense population.

PubMed

Lee, Seina; Xie, Lin; Wang, Yuexi; Vaidya, Neel; Baser, Onur

2018-06-01

To examine the comorbidity and economic burden among moderate-to-severe psoriasis (PsO) and/or psoriatic arthritis (PsA) patients in the US Department of Defense (DoD) population. This retrospective cohort claims analysis was conducted using DoD data from November 2010 to October 2015. Adult patients with ≥2 diagnoses of PsO and/or PsA (cases) were identified, and the first diagnosis date from November 2011 to October 2014 was defined as the index date. Patients were considered moderate-to-severe if they had ≥1 non-topical systemic therapy or phototherapy during the 12 months pre- or 1 month post-index date. Patients without a PsO/PsA diagnosis during the study period (controls) were matched to cases on a 10:1 ratio based on age, sex, region, and index year; the index date was randomly selected. One-to-one propensity score matching (PSM) was conducted to compare study outcomes in the first year post-index date, including healthcare resource utilization (HRU), costs, and comorbidity incidence. A total of 7,249 cases and 72,490 controls were identified. The mean age was 48.1 years. After PSM, comorbidity incidence was higher among cases, namely dyslipidemia (18.3% vs 13.5%, p < .001), hypertension (13.8% vs 8.7%, p < .001), and obesity (8.8% vs 6.1%, p < .001). Case patients had significantly higher HRU and costs, including inpatient ($2,196 vs $1,642; p < .0016), ambulatory ($8,804 vs 4,642; p < .001), emergency room ($432 vs $350; p < .001), pharmacy ($6,878 vs $1,160; p < .001), and total healthcare costs ($18,311 vs $7,795; p < .001). Claims data are collected for payment purposes; therefore, such data may have limitations for clinical research. During follow-up, DoD patients with moderate-to-severe PsO and/or PsA experienced significantly higher HRU, cost, and comorbidity burden.

Quality of Life and Performance Status From a Substudy Conducted Within a Prospective Phase 3 Randomized Trial of Concurrent Standard Radiation Versus Accelerated Radiation Plus Cisplatin for Locally Advanced Head and Neck Carcinoma: NRG Oncology RTOG 0129.

PubMed

Xiao, Canhua; Zhang, Qiang; Nguyen-Tân, Phuc Felix; List, Marcie; Weber, Randal S; Ang, K Kian; Rosenthal, David; Filion, Edith J; Kim, Harold; Silverman, Craig; Raben, Adam; Galloway, Thomas; Fortin, Andre; Gore, Elizabeth; Winquist, Eric; Jones, Christopher U; Robinson, William; Raben, David; Le, Quynh-Thu; Bruner, Deborah

2017-03-15

To analyze quality of life (QOL) and performance status (PS) for head and neck cancer (HNC) patients treated on NRG Oncology RTOG 0129 by treatment (secondary outcome) and p16 status, and to examine the association between QOL/PS and survival. Eligible patients were randomized into either an accelerated-fractionation arm or a standard-fractionation arm, and completed the Performance Status Scale for the Head and Neck (PSS-HN), the Head and Neck Radiotherapy Questionnaire (HNRQ), and the Spitzer Quality of Life Index (SQLI) at 8 time points from before treatment to 5 years after treatment. The results from the analysis of area under the curve showed that QOL/PS was not significantly different between the 2 arms from baseline to year after treatment (P ranged from .39 to .98). The results from general linear mixed models further supported the nonsignificant treatment effects until 5 years after treatment (P=.95, .90, and .84 for PSS-HN Diet, Eating, and Speech, respectively). Before treatment and after 1 year after treatment, p16-positive oropharyngeal cancer (OPC) patients had better QOL than did p16-negative patients (P ranged from .0283 to <.0001 for all questionnaires). However, QOL/PS decreased more significantly from pretreatment to the last 2 weeks of treatment in the p16-positive group than in the p16-negative group (P ranged from .0002 to <.0001). Pretreatment QOL/PS was a significant independent predictor of overall survival, progression-free survival, and local-regional failure but not of distant metastasis (P ranged from .0063 to <.0001). The results indicated that patients in both arms may have experienced similar QOL/PS. p16-positive patients had better QOL/PS at baseline and after 1 year of follow-up. Patients presenting with better baseline QOL/PS scores had better survival. Copyright © 2016 Elsevier Inc. All rights reserved.

Quality of Life and Performance Status From a Substudy Conducted Within a Prospective Phase 3 Randomized Trial of Concurrent Standard Radiation Versus Accelerated Radiation Plus Cisplatin for Locally Advanced Head and Neck Carcinoma: NRG Oncology RTOG 0129

PubMed Central

Xiao, Canhua; Zhang, Qiang; Nguyen-Tân, Phuc Felix; List, Marcie; Weber, Randal S.; Ang, K. Kian; Rosenthal, David; Filion, Edith J.; Kim, Harold; Silverman, Craig; Raben, Adam; Galloway, Thomas; Fortin, Andre; Gore, Elizabeth; Winquist, Eric; Jones, Christopher U.; Robinson, William; Raben, David; Le, Quynh-Thu; Bruner, Deborah

2016-01-01

Purpose/Objective(s) To analyze quality of life (QOL) and performance status (PS) for head and neck cancer (HNC) patients treated on NRG Oncology RTOG 0129 by treatment (secondary outcome) and p16 status, and to examine the association between QOL/PS and survival. Methods and Materials Eligible patients were randomized into either an accelerated-fractionation arm or a standard-fractionation arm, and completed the Performance Status Scale for the Head and Neck (PSS-HN), the Head and Neck Radiotherapy Questionnaire (HNRQ), and the Spitzer Quality of Life Index (SQLI) at 8 time points from before treatment to 5 years after treatment. Results The results from the analysis of area under the curve showed that QOL/PS was not significantly different between the 2 arms from baseline to year after treatment (P ranged from .39 to .98). The results from general linear mixed models further supported the nonsignificant treatment effects until 5 years after treatment (P=.95, .90, and .84 for PSS-HN Diet, Eating, and Speech, respectively). Before treatment and after 1 year after treatment, p16-positive oropharyngeal cancer (OPC) patients had better QOL than did p16-negative patients (P ranged from .0283 to <.0001 for all questionnaires). However, QOL/PS decreased more significantly from pretreatment to the last 2 weeks of treatment in the p16-positive group than in the p16-negative group (P ranged from .0002 to <.0001). Pretreatment QOL/PS was a significant independent predictor of overall survival, progression-free survival, and local-regional failure but not of distant metastasis (P ranged from .0063 to <.0001). Conclusions The results indicated that patients in both arms may have experienced similar QOL/PS. p16-positive patients had better QOL/PS at baseline and after 1 year of follow-up. Patients presenting with better baseline QOL/PS scores had better survival. PMID:27727063

Reasons for limiting drinking in an HIV primary care sample.

PubMed

Elliott, Jennifer C; Aharonovich, Efrat; Hasin, Deborah S

2014-06-01

Heavy drinking among individuals with HIV is associated with major health concerns (liver disease, medication nonadherence, immune functioning), but little is known about cognitive-motivational factors involved in alcohol consumption in this population, particularly reasons for limiting drinking. Urban HIV primary care patients (N = 254; 78.0% male; 94.5% African American or Hispanic) in a randomized trial of brief drinking-reduction interventions reported on reasons for limiting drinking, alcohol consumption, and alcohol dependence symptoms prior to intervention. Exploratory factor analysis indicated 3 main domains of reasons for limiting drinking: social reasons (e.g., responsibility to family), lifestyle reasons (e.g., religious/moral reasons), and impairment concerns (e.g., hangovers). These factors evidenced good internal consistency (αs = 0.76 to 0.86). Higher scores on social reasons for limiting drinking were associated with lower typical quantity, maximum quantity, and binge frequency (ps < 0.01), and higher scores on lifestyle reasons were associated with lower maximum quantity, binge frequency, and intoxication frequency (ps < 0.01). In contrast, higher scores on impairment concerns were associated with more frequent drinking and intoxication, and higher risk of alcohol dependence (ps < 0.05), likely because dependent drinkers are more familiar with alcohol-induced impairment. The current study is the first to explore reasons for limiting drinking among individuals with HIV and how these reasons relate to alcohol involvement. This study yields a scale that can be used to assess reasons for limiting drinking among HIV-positive drinkers and provides information that can be used to enhance interventions with this population. Discussing social and lifestyle reasons for limiting drinking among less extreme drinkers may support and validate these patients' efforts to limit engagement in heavy drinking; discussion of impairment reasons for limiting drinking may be a way to engage dependent drinkers in efforts to decrease their alcohol consumption. Copyright © 2014 by the Research Society on Alcoholism.

Reasons for limiting drinking in an HIV primary care sample

PubMed Central

Elliott, Jennifer C.; Aharonovich, Efrat; Hasin, Deborah

2015-01-01

BACKGROUND Heavy drinking among individuals with HIV is associated with major health concerns (liver disease, medication nonadherence, immune functioning), but little is known about cognitive-motivational factors involved in alcohol consumption in this population, particularly reasons for limiting drinking. METHODS Urban HIV primary care patients (N=254; 78.0% male; 94.5% African American or Hispanic) in a randomized trial of brief drinking-reduction interventions reported on reasons for limiting drinking, alcohol consumption, and alcohol dependence symptoms prior to intervention. RESULTS Exploratory factor analysis indicated three main domains of reasons for limiting drinking: social reasons (e.g., responsibility to family), lifestyle reasons (e.g., religious/moral reasons), and impairment concerns (e.g., hangovers). These factors evidenced good internal consistency (αs=0.76–0.86). Higher scores on social reasons for limiting drinking were associated with lower typical quantity, maximum quantity, and binge frequency (ps<0.01), and higher scores on lifestyle reasons were associated with lower maximum quantity, binge frequency, and intoxication frequency (ps<0.01). In contrast, higher scores on impairment concerns were associated with more frequent drinking and intoxication, and higher risk of alcohol dependence (ps<0.05), likely because dependent drinkers are more familiar with alcohol-induced impairment. CONCLUSIONS The current study is the first to explore reasons for limiting drinking among individuals with HIV, and how these reasons relate to alcohol involvement. This study yields a scale that can be used to assess reasons for limiting drinking among HIV-positive drinkers, and provides information that can be used to enhance interventions with this population. Discussing social and lifestyle reasons for limiting drinking among less extreme drinkers may support and validate these patients’ efforts to limit engagement in heavy drinking; discussion of impairment reasons for limiting drinking may be a way to engage dependent drinkers in efforts to decrease their alcohol consumption. PMID:24796381

Predictive factors in patients with hepatocellular carcinoma receiving sorafenib therapy using time-dependent receiver operating characteristic analysis.

PubMed

Nishikawa, Hiroki; Nishijima, Norihiro; Enomoto, Hirayuki; Sakamoto, Azusa; Nasu, Akihiro; Komekado, Hideyuki; Nishimura, Takashi; Kita, Ryuichi; Kimura, Toru; Iijima, Hiroko; Nishiguchi, Shuhei; Osaki, Yukio

2017-01-01

To investigate variables before sorafenib therapy on the clinical outcomes in hepatocellular carcinoma (HCC) patients receiving sorafenib and to further assess and compare the predictive performance of continuous parameters using time-dependent receiver operating characteristics (ROC) analysis. A total of 225 HCC patients were analyzed. We retrospectively examined factors related to overall survival (OS) and progression free survival (PFS) using univariate and multivariate analyses. Subsequently, we performed time-dependent ROC analysis of continuous parameters which were significant in the multivariate analysis in terms of OS and PFS. Total sum of area under the ROC in all time points (defined as TAAT score) in each case was calculated. Our cohort included 175 male and 50 female patients (median age, 72 years) and included 158 Child-Pugh A and 67 Child-Pugh B patients. The median OS time was 0.68 years, while the median PFS time was 0.24 years. On multivariate analysis, gender, body mass index (BMI), Child-Pugh classification, extrahepatic metastases, tumor burden, aspartate aminotransferase (AST) and alpha-fetoprotein (AFP) were identified as significant predictors of OS and ECOG-performance status, Child-Pugh classification and extrahepatic metastases were identified as significant predictors of PFS. Among three continuous variables (i.e., BMI, AST and AFP), AFP had the highest TAAT score for the entire cohort. In subgroup analyses, AFP had the highest TAAT score except for Child-Pugh B and female among three continuous variables. In continuous variables, AFP could have higher predictive accuracy for survival in HCC patients undergoing sorafenib therapy.

Use of random regression to estimate genetic parameters of temperament across an age continuum in a crossbred cattle population.

PubMed

Littlejohn, B P; Riley, D G; Welsh, T H; Randel, R D; Willard, S T; Vann, R C

2018-05-12

The objective was to estimate genetic parameters of temperament in beef cattle across an age continuum. The population consisted predominantly of Brahman-British crossbred cattle. Temperament was quantified by: 1) pen score (PS), the reaction of a calf to a single experienced evaluator on a scale of 1 to 5 (1 = calm, 5 = excitable); 2) exit velocity (EV), the rate (m/sec) at which a calf traveled 1.83 m upon exiting a squeeze chute; and 3) temperament score (TS), the numerical average of PS and EV. Covariates included days of age and proportion of Bos indicus in the calf and dam. Random regression models included the fixed effects determined from the repeated measures models, except for calf age. Likelihood ratio tests were used to determine the most appropriate random structures. In repeated measures models, the proportion of Bos indicus in the calf was positively related with each calf temperament trait (0.41 ± 0.20, 0.85 ± 0.21, and 0.57 ± 0.18 for PS, EV, and TS, respectively; P < 0.01). There was an effect of contemporary group (combinations of season, year of birth, and management group) and dam age (P < 0.001) in all models. From repeated records analyses, estimates of heritability (h2) were 0.34 ± 0.04, 0.31 ± 0.04, and 0.39 ± 0.04, while estimates of permanent environmental variance as a proportion of the phenotypic variance (c2) were 0.30 ± 0.04, 0.31 ± 0.03, and 0.34 ± 0.04 for PS, EV, and TS, respectively. Quadratic additive genetic random regressions on Legendre polynomials of age were significant for all traits. Quadratic permanent environmental random regressions were significant for PS and TS, but linear permanent environmental random regressions were significant for EV. Random regression results suggested that these components change across the age dimension of these data. There appeared to be an increasing influence of permanent environmental effects and decreasing influence of additive genetic effects corresponding to increasing calf age for EV, and to a lesser extent for TS. Inherited temperament may be overcome by accumulating environmental stimuli with increases in age, especially after weaning.

Premenstrual syndrome and fibromyalgia: the frequency of the coexistence and their effects on quality of life.

PubMed

Soyupek, Feray; Aydogan, Cigdem; Guney, Mehmet; Kose, Seyit Ali

2017-07-01

We aimed to investigate the association between Premenstrual syndrome (PMS) and fibromyalgia syndrome (FMS), to assess common symptoms and quality of life (QOL) of them. Patients with PMS formed the PMS group and age-matched healthy normal controls were included in the control group. The diagnosis of the FMS and PMS were based on new American College of Rheumatology FMS criteria and DSM-IV PMS criteria. FMS-related symptoms assessed by visual analog scale and number of tender points (TePs) were analyzed. QOL, PMS severity and FMS severity were assessed with SF-36, fibromyalgia impact questionnaire (FIQ) and premenstrual assessment form (PAF), respectively. Patients with PMS were divided into two subgroups according to coexistence of FMS or not. The frequency of FMS in PMS and control group were 20 and 0%, respectively (p = 0.002). FMS-related symptoms, number of TePs in the PMS group were higher than those in the control group. The mean mental component summary (MCS) score of SF-36 was low in the PMS group. The mean PAF score in PMS with FMS subgroup was higher than those in without FMS subgroup. The mean physical component summary of SF-36 was low in the PMS patient with FMS. There was correlation between PAF score and FIQ score (r = 0.476, p < 0.001). FMS was common among the patients with PMS and frequently seen in the PMS patients having severe premenstrual complaints. Mental QOL was distressed in the patients with PMS but while FMS accompanied to PMS, the physical QOL was decreased.

Do the self-concept and quality of life decrease in CP patients? Focussing on the predictors of self-concept and quality of life.

PubMed

Soyupek, Feray; Aktepe, Evrim; Savas, Serpil; Askin, Ayhan

2010-01-01

To find out if the quality of life (QOL) and self-concept of the children with cerebral palsy (CP) was different from that of children without disability, to investigate predictive variables that could affect self-concept and QOL. A total of 40 children with CP and 46 age-matched peers were included. The baseline characteristics including sex, type of CP, the level of disability according to Gross Motor Function Classification System (GMFCS) were recorded. Education levels of both children and parents, demographic features of parents, features of living area, usage of devices and associated impairments were filled out. Self-concept was measured using Piers-Harris Self-concept (PH) Scale. Quality of life was measured by Pediatric Quality of Life Inventory 4.0 (PedsQL). The physical and psychosocial health subscale scores of PedsQL (P-PedsQL and PS-PedsQL) were recorded. Significant differences in mean scores favouring the control group were found for PH scale, PedsQL scale (p < 0.001). P-PedsQL and PS-PedsQL of the CP group were lower than the control group (p < 0.001). PS-PedsQL report was significant predictor of self-concept. The presence of incontinence and GMFCS level were significant predictors of PedsQL and PPedsQL, respectively. Self-concept and QOL of the CP children were lower than the children without CP. Presence of incontinence, self-concept rating and GMFCS level were important to predict domains of QOL.

Routine hospital management of self-harm and risk of further self-harm: propensity score analysis using record-based cohort data.

PubMed

Steeg, S; Emsley, R; Carr, M; Cooper, J; Kapur, N

2018-01-01

The care received by people presenting to hospital following self-harm varies and it is unclear how different types of treatment affect risk of further self-harm. Observational cohort data from the Manchester Self-Harm Project, UK, included 16 456 individuals presenting to an Emergency Department with self-harm between 2003 and 2011. Individuals were followed up for 12 months. We also used data from a smaller cohort of individuals presenting to 31 hospitals in England during a 3-month period in 2010/2011, followed up for 6 months. Propensity score (PS) methods were used to address observed confounding. Missing data were imputed using multiple imputation. Following PS stratification, those who received a psychosocial assessment had a lower risk of repeat hospital attendance for self-harm than those who were not assessed [RR 0.87, 95% confidence interval (CI) 0.80-0.95]. The risk was reduced most among people less likely to be assessed. Following PS matching, we found no associations between risks of repeat self-harm and admission to a medical bed, referral to outpatient psychiatry or admission to a psychiatric bed. We did not find a relationship between psychosocial assessment and repeat self-harm in the 31 centre cohort. This study shows the potential value of using novel statistical techniques in large mental health datasets to estimate treatment effects. We found that specialist psychosocial assessment may reduce the risk of repeat self-harm. This type of routine care should be provided for all individuals who present to hospital after self-harm, regardless of perceived risk.