DISTRIBUTED AND ACCUMULATED REINFORCEMENT ARRANGEMENTS: EVALUATIONS OF EFFICACY AND PREFERENCE

PubMed Central

DELEON, ISER G.; CHASE, JULIE A.; FRANK-CRAWFORD, MICHELLE A.; CARREAU-WEBSTER, ABBEY B.; TRIGGS, MANDY M.; BULLOCK, CHRISTOPHER E.; JENNETT, HEATHER K.

2015-01-01

We assessed the efficacy of, and preference for, accumulated access to reinforcers, which allows uninterrupted engagement with the reinforcers but imposes an inherent delay required to first complete the task. Experiment 1 compared rates of task completion in 4 individuals who had been diagnosed with intellectual disabilities when reinforcement was distributed (i.e., 30-s access to the reinforcer delivered immediately after each response) and accumulated (i.e., 5-min access to the reinforcer after completion of multiple consecutive responses). Accumulated reinforcement produced response rates that equaled or exceeded rates during distributed reinforcement for 3 participants. Experiment 2 used a concurrent-chains schedule to examine preferences for each arrangement. All participants preferred delayed, accumulated access when the reinforcer was an activity. Three participants also preferred accumulated access to edible reinforcers. The collective results suggest that, despite the inherent delay, accumulated reinforcement is just as effective and is often preferred by learners over distributed reinforcement. PMID:24782203

Incentive and Reminder Strategies to Improve Response Rate for Internet-Based Physician Surveys: A Randomized Experiment

PubMed Central

Wittich, Christopher M; Daniels, Wendlyn L; West, Colin P; Harris, Ann M; Beebe, Timothy J

2016-01-01

Background Most research on how to enhance response rates in physician surveys has been done using paper surveys. Uncertainties remain regarding how to enhance response rates in Internet-based surveys. Objective To evaluate the impact of a low-cost nonmonetary incentive and paper mail reminders (formal letter and postcard) on response rates in Internet-based physician surveys. Methods We executed a factorial-design randomized experiment while conducting a nationally representative Internet-based physician survey. We invited 3966 physicians (randomly selected from a commercial database of all licensed US physicians) via email to complete an Internet-based survey. We used 2 randomly assigned email messages: one message offered a book upon survey completion, whereas the other did not mention the book but was otherwise identical. All nonrespondents received several email reminders. Some physicians were further assigned at random to receive 1 reminder via paper mail (either a postcard or a letter) or no paper reminder. The primary outcome of this study was the survey response rate. Results Of the 3966 physicians who were invited, 451 (11.4%) responded to at least one survey question and 336 (8.5%) completed the entire survey. Of those who were offered a book, 345/2973 (11.6%) responded compared with 106/993 (10.7%) who were not offered a book (odds ratio 1.10, 95% CI 0.87-1.38, P=.42). Regarding the paper mail reminder, 168/1572 (10.7%) letter recipients, 148/1561 (9.5%) postcard recipients, and 69/767 (9.0%) email-only recipients responded (P=.35). The response rate for those receiving letters or postcards was similar (odds ratio 1.14, 95% CI 0.91-1.44, P=.26). Conclusions Offering a modest nonmonetary incentive and sending a paper reminder did not improve survey response rate. Further research on how to enhance response rates in Internet-based physician surveys is needed. PMID:27637296

Incentive and Reminder Strategies to Improve Response Rate for Internet-Based Physician Surveys: A Randomized Experiment.

PubMed

Cook, David A; Wittich, Christopher M; Daniels, Wendlyn L; West, Colin P; Harris, Ann M; Beebe, Timothy J

2016-09-16

Most research on how to enhance response rates in physician surveys has been done using paper surveys. Uncertainties remain regarding how to enhance response rates in Internet-based surveys. To evaluate the impact of a low-cost nonmonetary incentive and paper mail reminders (formal letter and postcard) on response rates in Internet-based physician surveys. We executed a factorial-design randomized experiment while conducting a nationally representative Internet-based physician survey. We invited 3966 physicians (randomly selected from a commercial database of all licensed US physicians) via email to complete an Internet-based survey. We used 2 randomly assigned email messages: one message offered a book upon survey completion, whereas the other did not mention the book but was otherwise identical. All nonrespondents received several email reminders. Some physicians were further assigned at random to receive 1 reminder via paper mail (either a postcard or a letter) or no paper reminder. The primary outcome of this study was the survey response rate. Of the 3966 physicians who were invited, 451 (11.4%) responded to at least one survey question and 336 (8.5%) completed the entire survey. Of those who were offered a book, 345/2973 (11.6%) responded compared with 106/993 (10.7%) who were not offered a book (odds ratio 1.10, 95% CI 0.87-1.38, P=.42). Regarding the paper mail reminder, 168/1572 (10.7%) letter recipients, 148/1561 (9.5%) postcard recipients, and 69/767 (9.0%) email-only recipients responded (P=.35). The response rate for those receiving letters or postcards was similar (odds ratio 1.14, 95% CI 0.91-1.44, P=.26). Offering a modest nonmonetary incentive and sending a paper reminder did not improve survey response rate. Further research on how to enhance response rates in Internet-based physician surveys is needed.

Improving response rates using a monetary incentive for patient completion of questionnaires: an observational study

PubMed Central

Brealey, Stephen D; Atwell, Christine; Bryan, Stirling; Coulton, Simon; Cox, Helen; Cross, Ben; Fylan, Fiona; Garratt, Andrew; Gilbert, Fiona J; Gillan, Maureen GC; Hendry, Maggie; Hood, Kerenza; Houston, Helen; King, David; Morton, Veronica; Orchard, Jo; Robling, Michael; Russell, Ian T; Torgerson, David; Wadsworth, Valerie; Wilkinson, Clare

2007-01-01

Background Poor response rates to postal questionnaires can introduce bias and reduce the statistical power of a study. To improve response rates in our trial in primary care we tested the effect of introducing an unconditional direct payment of £5 for the completion of postal questionnaires. Methods We recruited patients in general practice with knee problems from sites across the United Kingdom. An evidence-based strategy was used to follow-up patients at twelve months with postal questionnaires. This included an unconditional direct payment of £5 to patients for the completion and return of questionnaires. The first 105 patients did not receive the £5 incentive, but the subsequent 442 patients did. We used logistic regression to analyse the effect of introducing a monetary incentive to increase the response to postal questionnaires. Results The response rate following reminders for the historical controls was 78.1% (82 of 105) compared with 88.0% (389 of 442) for those patients who received the £5 payment (diff = 9.9%, 95% CI 2.3% to 19.1%). Direct payments significantly increased the odds of response (adjusted odds ratio = 2.2, 95% CI 1.2 to 4.0, P = 0.009) with only 12 of 442 patients declining the payment. The incentive did not save costs to the trial – the extra cost per additional respondent was almost £50. Conclusion The direct payment of £5 significantly increased the completion of postal questionnaires at negligible increase in cost for an adequately powered study. PMID:17326837

An examination of responses to surveys among Filipino-Australian migrants.

PubMed

Maneze, Della; Everett, Bronwyn; DiGiacomo, Michelle; Davidson, Patricia M; Salamonson, Yenna

2016-11-18

Background Surveys are frequently used to collect data. Although paper surveys are commonly used, online surveys are gaining in popularity, with the inclusion of open-ended questions (OEQs) allowing respondents to freely express their views. Little is known about how Filipino-Australian migrants respond to surveys. There is some concern about the usefulness of OEQs administered to culturally and linguistically diverse migrants, who may have limited capacity to articulate their thoughts in writing. Aim To examine the responses of Filipino-Australian migrants to a survey. Discussion A total of 552 respondents were recruited, of whom 428 (78%) completed the questionnaire online. The overall response rate to the OEQs was 69%, with higher completion rates among those given a paper-based questionnaire and those with university educations. Conclusion Filipino migrants with functional English language skills responded well to the online survey. Paper-based administration elicited more OEQ responses, which is attributed to greater interaction between participants and researchers. Those with university educations may have more capacity to express themselves in English and were therefore more likely to complete the OEQs. Implications for practice The high response rate obtained in this study suggests that among Filipino-Australian migrants who rated their English language skills and educational level highly, the translation of OEQs may not be necessary. This has important implications for resources in research. Face-to-face interaction between participants and researchers is an important strategy for increasing the rates of response to OEQs.

Rituximab plus bendamustine or chlorambucil for chronic lymphocytic leukemia: primary analysis of the randomized, open-label MABLE study

PubMed Central

Michallet, Anne-Sophie; Aktan, Melih; Hiddemann, Wolfgang; Ilhan, Osman; Johansson, Peter; Laribi, Kamel; Meddeb, Balkis; Moreno, Carol; Raposo, João; Schuh, Anna; Ünal, Ali; Widenius, Tom; Bernhardt, Alf; Kellershohn, Kerstin; Messeri, Dimitri; Osborne, Stuart; Leblond, Véronique

2018-01-01

MABLE investigated the efficacy and safety of rituximab plus bendamustine or rituximab plus chlorambucil in fludarabine-ineligible patients with chronic lymphocytic leukemia. Patients received rituximab plus bendamustine or rituximab plus chlorambucil every four weeks for six cycles. Rituximab plus chlorambucil-treated patients without a complete response after Cycle 6 received chlorambucil monotherapy for at least six additional cycles or until complete response. The primary endpoint was complete response rate (confirmed by bone marrow biopsy) after Cycle 6 in first-line patients. Secondary endpoints included progression-free survival, overall survival, minimal residual disease, and safety. Overall, 357 patients were randomized (rituximab plus bendamustine, n=178; rituximab plus chlorambucil, n=179; intent-to-treat population), including 241 first-line patients (n=121 and n=120, respectively); 355 patients received treatment (n=177 and n=178, respectively; safety population). In first-line patients, complete response rate after Cycle 6 (rituximab plus bendamustine, 24%; rituximab plus chlorambucil, 9%; P=0.002) and median progression-free survival (rituximab plus bendamustine, 40 months; rituximab plus chlorambucil, 30 months; P=0.003) were higher with rituximab plus bendamustine than rituximab plus chlorambucil. Overall response rate and overall survival were not different. In first-line patients with a complete response, minimal residual disease-negativity was higher with rituximab plus bendamustine than rituximab plus chlorambucil (66% vs. 36%). Overall adverse event incidence was similar (rituximab plus bendamustine, 98%; rituximab plus chlorambucil, 97%). Rituximab plus bendamustine may be a valuable first-line option for fludarabine-ineligible patients with chronic lymphocytic leukemia. PMID:29419437

Achievement and High School Completion Rates of Hispanic Students with No English Language Skills Compared to Hispanic Students with Some English Language Skills Attending the Same High School in an Immigrant Responsive City

ERIC Educational Resources Information Center

Garrison, Joanne M.

2012-01-01

The purpose of the study was to determine achievement and high school completion rates of Hispanic students (n = 13) with no English language skills compared to Hispanic students (n = 11) with some English language skills attending the same high school in an immigrant responsive city. All students were in attendance in the research school…

Mode of delivery affected questionnaire response rates in a birth cohort study.

PubMed

Bray, Isabelle; Noble, Sian; Robinson, Ross; Molloy, Lynn; Tilling, Kate

2017-01-01

Cohort studies must collect data from their participants as economically as possible, while maintaining response rates. This randomized controlled trial investigated whether offering a choice of online or paper questionnaires resulted in improved response rates compared with offering online first. Eligible participants were young people in the Avon Longitudinal Study of Parents and Children (ALSPAC) study (born April 1, 1991, to December 31, 1992, in the Avon area). After exclusions, 8,795 participants were randomized. The "online first" group were invited to complete the questionnaire online. The "choice" group were also sent a paper questionnaire and offered a choice of completion method. The trial was embedded within routine data collection. The main outcome measure was the number of questionnaires returned. Data on costs were also collected. Those in the "online first" arm of the trial were less likely to return a questionnaire [adjusted odds ratio: 0.90; 95% confidence interval (CI): 0.82, 0.99]. The "choice" arm was more expensive (mean difference per participant £0.71; 95% CI: £0.65, £0.76). It cost an extra £47 to have one extra person to complete the questionnaire in the "choice" arm. Offering a choice of completion methods (paper or online) for questionnaires in ALSPAC increased response rates but was more expensive than offering online first. Copyright © 2016 The Author(s). Published by Elsevier Inc. All rights reserved.

Increasing response rates to follow-up questionnaires in health intervention research: Randomized controlled trial of a gift card prize incentive.

PubMed

Morgan, Amy J; Rapee, Ronald M; Bayer, Jordana K

2017-08-01

Background/aims Achieving a high response rate to follow-up questionnaires in randomized controlled trials of interventions is important for study validity. Few studies have tested the value of incentives in increasing response rates to online questionnaires in clinical trials of health interventions. This study evaluated the effect of a gift card prize-draw incentive on response rates to follow-up questionnaires within a trial of an online health intervention. Method The study was embedded in a host randomized controlled trial of an online parenting program for child anxiety. A total of 433 participants were randomly allocated to one of two groups: (1) being informed that they would enter a gift card prize-draw if they completed the final study questionnaire (24-week follow-up) and (2) not informed about the prize-draw. All participants had a 1 in 20 chance of winning an AUD50 gift card after they completed the online questionnaire. Results The odds of the informed group completing the follow-up questionnaire were significantly higher than the uninformed group, (79.6% vs 68.5%, odds ratio = 1.79, 95% confidence interval = 1.15-2.79). This response rate increase of 11.1% (95% confidence interval = 2.8-19.1) occurred in both intervention and control groups in the host randomized controlled trial. The incentive was also effective in increasing questionnaire commencement (84.6% vs 75.9%, odds ratio = 1.74, 95% confidence interval = 1.07-2.84) and reducing the delay in completing the questionnaire (19.9 vs 22.6 days, hazard ratio = 1.34, 95% confidence interval = 1.07-1.67). Conclusion This study adds to evidence for the effectiveness of incentives to increase response rates to follow-up questionnaires in health intervention trials.

Efficacy and safety of olanzapine combined with aprepitant, palonosetron, and dexamethasone for preventing nausea and vomiting induced by cisplatin-based chemotherapy in gynecological cancer: KCOG-G1301 phase II trial.

PubMed

Abe, Masakazu; Hirashima, Yasuyuki; Kasamatsu, Yuka; Kado, Nobuhiro; Komeda, Satomi; Kuji, Shiho; Tanaka, Aki; Takahashi, Nobutaka; Takekuma, Munetaka; Hihara, Hanako; Ichikawa, Yoshikazu; Itonaga, Yui; Hirakawa, Tomoko; Nasu, Kaei; Miyagi, Kanoko; Murakami, Junko; Ito, Kimihiko

2016-02-01

Olanzapine is effective in chemotherapy-induced nausea and vomiting (CINV). In patients receiving highly emetogenic chemotherapy (HEC), its efficacy was reported as rescue therapy for breakthrough emesis refractory to triplet therapy (palonosetron, aprepitant, and dexamethasone). However, its preventive effects with triplet therapy for CINV are unknown. This study aimed to investigate efficacy and safety of preventive use of olanzapine with triplet therapy for CINV of HEC. This study is a prospective multicenter study conducted by Kansai Clinical Oncology Group. Forty chemo-naïve gynecological cancer patients receiving HEC with cisplatin (≥50 mg/m(2)) were enrolled. Oral olanzapine (5 mg) was administered with triplet therapy a day prior to cisplatin administration and on days 1-5. The primary endpoint was complete response (no vomiting and no rescue) rate for the overall phase (0-120 h post-chemotherapy). Secondary endpoints were complete response rate for acute phase (0-24 h post-chemotherapy) and delayed phase (24-120 h post-chemotherapy) and complete control (no vomiting, no rescue, and no significant nausea) rate and total control (no vomiting, no rescue, and no nausea) rate for each phase. These endpoints were evaluated during the first cycle of chemotherapy. Complete response rates for acute, delayed, and overall phases were 97.5, 95.0, and 92.5 %, respectively. Complete control rates were 92.5, 87.5, and 82.5 %, respectively. Total control rates were 87.5, 67.5, and 67.5 %, respectively. There were no grade 3 or 4 adverse events. Preventive use of olanzapine combined with triplet therapy gives better results than those from previously reported studies of triplet therapy.

Spontaneous Eye-Blink Rate as an Index of Reward Responsivity: Validation and Links to Bipolar Disorder

PubMed Central

Peckham, Andrew D.; Johnson, Sheri L.

2015-01-01

Extensive research supports the role of striatal dopamine in pursuing and responding to reward, and that eye-blink rate is a valid indicator of striatal dopamine. This study tested whether phasic changes in blink rate could provide an index of reward pursuit. This hypothesis was tested in people with bipolar I disorder (BD; a population with aberrations in reward responsivity), and in those without BD. Thirty-one adults with BD and 28 control participants completed a laboratory task involving effort towards monetary reward. Blink rate was recorded using eye-tracking at baseline, reward anticipation, and post-reward. Those in the BD group completed self-report measures relating to reward and ambition. Results showed that across all participants, blink rates increased from reward anticipation to post-reward. In the BD group, reward-relevant measures were strongly correlated with variation in blink rate. These findings provide validation for phasic changes in blink rate as an index of reward response. PMID:27274949

A small unconditional non-financial incentive suggests an increase in survey response rates amongst older general practitioners (GPs): a randomised controlled trial study

PubMed Central

2013-01-01

Background Few studies have investigated the effect of small unconditional non-monetary incentives on survey response rates amongst GPs or medical practitioners. This study assessed the effectiveness of offering a small unconditional non-financial incentive to increase survey response rates amongst general practitioners within a randomised controlled trial (RCT). Methods An RCT was conducted within a general practice survey that investigated how to prolong working lives amongst ageing GPs in Australia. GPs (n = 125) were randomised to receive an attractive pen or no pen during their first invitation for participation in a survey. GPs could elect to complete the survey online or via mail. Two follow up reminders were sent without a pen to both groups. The main outcome measure was response rates. Results The response rate for GPs who received a pen was higher in the intervention group (61.9%) compared to the control group (46.8%). This study did not find a statistically significant effect of a small unconditional non-financial incentive (in the form of a pen) on survey response rates amongst GPs (Odds ratio, 95% confidence interval: 1.85 (0.91 to 3.77). No GPs completed the online version. Conclusion A small unconditional non-financial incentives, in the form of a pen, may improve response rates for GPs. PMID:23899116

A small unconditional non-financial incentive suggests an increase in survey response rates amongst older general practitioners (GPs): a randomised controlled trial study.

PubMed

Pit, Sabrina Winona; Hansen, Vibeke; Ewald, Dan

2013-07-30

Few studies have investigated the effect of small unconditional non-monetary incentives on survey response rates amongst GPs or medical practitioners. This study assessed the effectiveness of offering a small unconditional non-financial incentive to increase survey response rates amongst general practitioners within a randomised controlled trial (RCT). An RCT was conducted within a general practice survey that investigated how to prolong working lives amongst ageing GPs in Australia. GPs (n = 125) were randomised to receive an attractive pen or no pen during their first invitation for participation in a survey. GPs could elect to complete the survey online or via mail. Two follow up reminders were sent without a pen to both groups. The main outcome measure was response rates. The response rate for GPs who received a pen was higher in the intervention group (61.9%) compared to the control group (46.8%). This study did not find a statistically significant effect of a small unconditional non-financial incentive (in the form of a pen) on survey response rates amongst GPs (Odds ratio, 95% confidence interval: 1.85 (0.91 to 3.77). No GPs completed the online version. A small unconditional non-financial incentives, in the form of a pen, may improve response rates for GPs.

Adjuvant topical treatment with imiquimod 5% after excisional surgery for VIN 2/3.

PubMed

Gentile, M; Bianchi, P; Sesti, F; Sopracordevole, F; Biamonti, A; Scirpa, P; Schimberni, M; Cozza, G; Marziani, R; Di Martino, G; Catalano, A; Milazzo, G N; Zinna, M; Caserta, D; Frega, A

2014-10-01

Vulvar intraepithelial neoplasia (VIN) is a premalignant lesion of the vulva. The incidence of VIN is increasing. The surgery is currently the gold standard therapy for VIN, but Imiquimod could be a completion to surgery. The aim of this study is to compare the overall complete response, the recurrence rate and the risk factors for recurrence among two groups of patients: women with high grade VIN underwent surgery and patients treated with surgery plus Imiquimod. 80 patients with histologically diagnosed VIN 2/3 were enrolled in this prospective study. Our patients were divided into two groups: 40 women underwent surgery (A) and 40 patients were treated with surgery plus Imiquimod (B). All women had a 5-year follow-up. Recurrence rate and complete response were evaluated. The following patients' characteristics were analyzed: smoke, multifocal disease, multicentric disease, degree of the lesion. In the group A recurrence rate was 44.8%, in the group B it was 48.4%. In both groups the presence of multifocal lesions (p = 0.02) and VIN 3 (p = 0.006) before treatment was associated with a higher risk of recurrence. This study found that surgery remains the principal approach for VIN with regard to relapse and complete response since the treatment with Imiquimod associated with surgery didn't show a lower recurrence rate. Although the surgical treatments remain the best therapeutic option for VIN with regard to recurrence and overall complete response, the combined therapy seems to be an interesting modality, but further studies are needed.

[Personal experience with VP-16 in the treatment of malignant lymphomas at the Chemotherapy Clinic of the Oncology Center--M. Skłodowskiej-Curie Institute in Warsaw].

PubMed

Pałucka, A; Walewski, J; Siedlecki, P; Zborzil, J

1990-01-01

Eighteen patients with advanced malignant lymphomas who had progressed with previous chemotherapy were treated with LEPP (chlorambucil, VP-16, procarbazine, prednisone). One complete response and 5 partial remissions were observed, yielding an overall response rate of 33%, with median response duration of about 2 months. Twenty three patients with advanced Hodgkin's disease all who had progressed with previous chemotherapy (MOPP and ABVD) and 19 of them also after radiation therapy were treated with third line salvage chemotherapy consisting of OPEC (VP- 16, chlorambucil, vincristine and prednisone). Two complete response and 3 partial remissions were obtained for overall response rate of 21% with median duration of about 9 months.

Metabolic response of rectal cancer assessed by 18-FDG PET following chemoradiotherapy is prognostic for patient outcome.

PubMed

Yeung, J M C; Kalff, V; Hicks, R J; Drummond, E; Link, E; Taouk, Y; Michael, M; Ngan, S; Lynch, A C; Heriot, A G

2011-05-01

Complete pathological response has proven prognostic benefits in patients with locally advanced rectal cancer treated with neoadjuvant chemoradiotherapy. Sequential 18-FDG PET may be an early surrogate for pathological response to chemoradiotherapy. The aim of this study was to identify whether metabolic response measured by FDG PET following chemoradiotherapy is prognostic for tumor recurrence and survival following neoadjuvant therapy and surgical treatment for primary rectal cancer. Patients with primary rectal cancer treated by long-course neoadjuvant chemoradiotherapy followed by surgery had FDG PET performed before and 4 weeks after treatment, before surgical resection was performed. Retrospective chart review was undertaken for patient demographics, tumor staging, recurrence rates, and survival. : Between 2000 and 2007, 78 patients were identified (53 male, 25 female; median age, 64 y). After chemoradiotherapy, 37 patients (47%) had a complete metabolic response, 26 (33%) had a partial metabolic response, and 14 (18%) had no metabolic response as assessed by FDG PET (1 patient had missing data). However, only 4 patients (5%) had a complete pathological response. The median postoperative follow-up period was 3.1 years during which 14 patients (19%) had a recurrence: 2 local, 9 distant, and 3 with both local and distant. The estimated percentage without recurrence was 77% at 5 years (95% CI 66%-89%). There was an inverse relationship between FDG PET metabolic response and the incidence of recurrence within 3 years (P = .04). Kaplan-Meier analysis of FDG PET metabolic response and overall survival demonstrated a significant difference in survival among patients in the 3 arms: complete, partial, and no metabolic response (P = .04); the patients with complete metabolic response had the best prognosis. Complete or partial metabolic response on PET following neoadjuvant chemoradiotherapy and surgery predicts a lower local recurrence rate and improved survival compared with patients with no metabolic response. Metabolic response may be used to stratify prognosis in patients with rectal cancer.

Results of a minimally invasive technique for treatment of unicameral bone cysts.

PubMed

Mik, Gökçe; Arkader, Alexandre; Manteghi, Alexander; Dormans, John P

2009-11-01

Unicameral bone cysts are benign bone lesions commonly seen in pediatric patients. Several treatment methods have been described with variable results and high recurrence rates. We previously reported short-term success of a minimally invasive technique that includes combining percutaneous decompression and grafting with medical-grade calcium sulfate pellets. The purpose of this study was to review the additional long-term results with a minimum followup of 24 months (average, 37 months; range, 24-70 months). We identified 55 patients with an average age of 10.8 years (range, 1.3-18 years). Forty-one of 55 lesions occurred in the humerus and femur. Forty-four of 55 (80%) patients had a partial or complete response after initial surgery; of these, seven obtained a partial or complete response after a repeat surgery (cumulative healing rate, 94%). Two patients underwent a third surgery (cumulative healing rate, 98%). One underwent a third repeat surgery (cumulative healing rate, 100%). There were no major complications associated with the procedure. Two patients had a superficial infection that resolved with oral antibiotics. Although some patients required a repeat procedure, complete or partial response at a minimum 24 months' followup was achieved in all patients. Level IV, therapeutic study. See Guidelines for Authors for a complete description of levels of evidence.

Effects of a Financial Incentive on Health Researchers’ Response to an Online Survey: a Randomized Controlled Trial

PubMed Central

Petticrew, Mark; Calnan, Mike; Nazareth, Irwin

2010-01-01

Background Nonresponse to questionnaires can affect the validity of surveys and introduce bias. Offering financial incentives can increase response rates to postal questionnaires, but the effect of financial incentives on response rates to online surveys is less clear. Objective As part of a survey, we aimed to test whether knowledge of a financial incentive would increase the response rate to an online questionnaire. Methods A randomized controlled trial of 485 UK-based principal investigators of publicly funded health services and population health research. Participants were contacted by email and invited to complete an online questionnaire via an embedded URL. Participants were randomly allocated to groups with either “knowledge of” or “no knowledge of” a financial incentive (£10 Amazon gift voucher) to be provided on completion of the survey. At the end of the study, gift vouchers were given to all participants who completed the questionnaire regardless of initial randomization status. Four reminder emails (sent from the same email address as the initial invitation) were sent out to nonrespondents at one, two, three, and four weeks; a fifth postal reminder was also undertaken. The primary outcome measure for the trial was the response rate one week after the second reminder. Response rate was also measured at the end of weeks one, two, three, four, and five, and after a postal reminder was sent. Results In total, 243 (50%) questionnaires were returned (232 completed, 11 in which participation was declined). One week after the second reminder, the response rate in the “knowledge” group was 27% (66/244) versus 20% (49/241) in the “no knowledge” group (χ21 = 3.0, P = .08). The odds ratio for responding among those with knowledge of an incentive was 1.45 (95% confidence interval [CI] 0.95 - 2.21). At the third reminder, participants in the “no knowledge” group were informed about the incentive, ending the randomized element of the study. However we continued to follow up all participants, and from reminder three onwards, no significant differences were observed in the response rates of the two groups. Conclusions Knowledge of a financial incentive did not significantly increase the response rate to an online questionnaire. Future surveys should consider including a randomized element to further test the utility of offering incentives of other types and amounts to participate in online questionnaires. Trial Registration ISRCTN59912797; http://www.controlled-trials.com/ISRCTN59912797 (Archived by WebCite at http://www.webcitation.org/5iPPLbT7s) PMID:20457556

Distributed and accumulated reinforcement arrangements: evaluations of efficacy and preference.

PubMed

DeLeon, Iser G; Chase, Julie A; Frank-Crawford, Michelle A; Carreau-Webster, Abbey B; Triggs, Mandy M; Bullock, Christopher E; Jennett, Heather K

2014-01-01

We assessed the efficacy of, and preference for, accumulated access to reinforcers, which allows uninterrupted engagement with the reinforcers but imposes an inherent delay required to first complete the task. Experiment 1 compared rates of task completion in 4 individuals who had been diagnosed with intellectual disabilities when reinforcement was distributed (i.e., 30-s access to the reinforcer delivered immediately after each response) and accumulated (i.e., 5-min access to the reinforcer after completion of multiple consecutive responses). Accumulated reinforcement produced response rates that equaled or exceeded rates during distributed reinforcement for 3 participants. Experiment 2 used a concurrent-chains schedule to examine preferences for each arrangement. All participants preferred delayed, accumulated access when the reinforcer was an activity. Three participants also preferred accumulated access to edible reinforcers. The collective results suggest that, despite the inherent delay, accumulated reinforcement is just as effective and is often preferred by learners over distributed reinforcement. © Society for the Experimental Analysis of Behavior.

Participation rates, response bias and response behaviours in the community survey of the Swiss Spinal Cord Injury Cohort Study (SwiSCI).

PubMed

Fekete, Christine; Segerer, Wolfgang; Gemperli, Armin; Brinkhof, Martin W G

2015-10-08

Surveying persons with disabilities is challenging, as targeted subjects may experience specific barriers to survey participation. Here we report on participation rates and response behaviour in a community survey of people with spinal cord injury (SCI) in Switzerland. The cross-sectional survey was implemented as part of the Swiss Spinal Cord Injury Cohort Study (SwiSCI) and represents the largest population-based SCI survey in Europe including nearly 2000 persons. Design features to enhance participation rates included the division of the questionnaire volume over three successive modules; recurrent and mixed-mode reminding of non-responders; and mixed-mode options for response. We describe participation rates of the SwiSCI community survey (absolute and cumulative cooperation, contact, response, and attrition rates) and report on response rates in relation to recruitment efforts. Potential non-response bias and the association between responders' characteristics and response behaviour (response speed: reminding until participation; response mode: paper-pencil vs. online completion) were assessed using regression modelling. Over the successive modules, absolute response rates were 61.1, 80.6 and 87.3% which resulted in cumulative response rates of 49.3 and 42.6% for the second and third modules. Written reminders effectively increased response rates, with the first reminder showing the largest impact. Telephone reminders, partly with direct telephone interviewing, enhanced response rate to the first module, but were essentially redundant in subsequent modules. Non-response to the main module was related to current age, membership of Swiss Paraplegic Association (SPA) and time since injury, but not to gender, lesion level and preferred language of response. Response speed increased with household income, but was not associated to other sociodemographic factors, lesion characteristics or health indicators. We found significant associations between online completion and male gender, younger age, higher education, higher income, SPA membership, tetraplegia, longer time since injury, higher quality of life, and more participation restrictions. In this sample with little non-response bias, recurrent and mixed-mode reminding and mixed-mode options for response were key features of optimizing survey design.

Tumor Response and Survival Predicted by Post-Therapy FDG-PET/CT in Anal Cancer

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

Schwarz, Julie K.; Siegel, Barry A.; Dehdashti, Farrokh

2008-05-01

Purpose: To evaluate the response to therapy for anal carcinoma using post-therapy imaging with positron emission tomography (PET)/computed tomography and F-18 fluorodeoxyglucose (FDG) and to compare the metabolic response with patient outcome. Patients and Methods: This was a prospective cohort study of 53 consecutive patients with anal cancer. All patients underwent pre- and post-treatment whole-body FDG-PET/computed tomography. Patients had been treated with external beam radiotherapy and concurrent chemotherapy. Whole-body FDG-PET was performed 0.9-5.4 months (mean, 2.1) after therapy completion. Results: The post-therapy PET scan did not show any abnormal FDG uptake (complete metabolic response) in 44 patients. Persistent abnormal FDGmore » uptake (partial metabolic response) was found in the anal tumor in 9 patients. The 2-year cause-specific survival rate was 94% for patients with a complete vs. 39% for patients with a partial metabolic response in the anal tumor (p = 0.0008). The 2-year progression-free survival rate was 95% for patients with a complete vs. 22% for patients with a partial metabolic response in the anal tumor (p < 0.0001). A Cox proportional hazards model of survival outcome indicated that a complete metabolic response was the most significant predictor of progression-free survival in our patient population (p = 0.0003). Conclusions: A partial metabolic response in the anal tumor as determined by post-therapy FDG-PET is predictive of significantly decreased progression-free and cause-specific survival after chemoradiotherapy for anal cancer.« less

ROCView: prototype software for data collection in jackknife alternative free-response receiver operating characteristic analysis

PubMed Central

Thompson, J; Hogg, P; Thompson, S; Manning, D; Szczepura, K

2012-01-01

ROCView has been developed as an image display and response capture (IDRC) solution to image display and consistent recording of reader responses in relation to the free-response receiver operating characteristic paradigm. A web-based solution to IDRC for observer response studies allows observations to be completed from any location, assuming that display performance and viewing conditions are consistent with the study being completed. The simplistic functionality of the software allows observations to be completed without supervision. ROCView can display images from multiple modalities, in a randomised order if required. Following registration, observers are prompted to begin their image evaluation. All data are recorded via mouse clicks, one to localise (mark) and one to score confidence (rate) using either an ordinal or continuous rating scale. Up to nine “mark-rating” pairs can be made per image. Unmarked images are given a default score of zero. Upon completion of the study, both true-positive and false-positive reports can be downloaded and adapted for analysis. ROCView has the potential to be a useful tool in the assessment of modality performance difference for a range of imaging methods. PMID:22573294

Effects on response rates and costs of stamps vs business reply in a mail survey of physicians.

PubMed

Urban, N; Anderson, G L; Tseng, A

1993-05-01

In the general population, the use of stamps rather than business reply postage significantly improves response rates in mail surveys. Among physicians, however, a smaller effect might be anticipated due to their greater sophistication. An experiment was conducted to test the hypothesis that stamps would improve response rates and lower costs in a physician survey that included intensive follow up. In 1989, 380 physicians who reported providing primary care were surveyed. The protocol included two mailings, a postcard reminder, and two telephone reminders. Physicians were randomly assigned to receive a return envelope with a first-class stamp or an envelope that had been preprinted "business reply mail" in the first and second mailings. Response rates, calculated as completed surveys divided by eligible physicians, were 83.8 and 72.1% for stamps and business reply respectively, a difference of 11.7 percentage points (p < 0.01). Moreover, the total cost per completed survey was $11.18 for the physicians receiving stamps and $14.25 for the physicians receiving business reply. As in mail surveys of the general public, the use of first-class stamps on return envelopes both improves response rates and reduces cost in surveys of physicians.

Complete remission of platinium refractory ovarian cancer with second line tegafur with uracil monotherapy: a case report.

PubMed

Camci, Celalettin; Sevinc, Alper; Aslan, Yilmaz; Kalender, Mehmet Emin; Buyukberber, Suleyman

2009-03-01

Ovarian cancer remains one of the most lethal of all gynecologic malignancies, accounting for more deaths than cervical and uterine cancer combined. Advanced ovarian cancer is a chemosensitive tumor and most patients initially respond to platinum-based combination chemotherapy with response rates of about 70%, including a high proportion of complete responses. However, despite aggressive surgery and chemotherapy, more than 80% of patients will relapse and will then be treated with second line chemotherapy with objective responses in about 20% of patients and even lower percentages of complete responses. We observed a 42-months of complete response with administration of 1-[2-tetrahydrofuryl]-5-fluorouracil mixed with uracil (UFT) in patient with platinium refractory ovarian cancer. We report a complete remission of platinium refractory epithelial ovarian cancer with UFT monotherapy that was not reported previously.

The requirement for prior consent to participate on survey response rates: a population-based survey in Grampian

PubMed Central

Angus, Val C; Entwistle, Vikki A; Emslie, Margaret J; Walker, Kim A; Andrew, Jane E

2003-01-01

Background A survey was carried out in the Grampian region of Scotland with a random sample of 10,000 adults registered with a General Practitioner in Grampian. The study complied with new legislation requiring a two-stage approach to identify and recruit participants, and examined the implications of this for response rates, non-response bias and speed of response. Methods A two-stage survey was carried out consistent with new confidentiality guidelines. Individuals were contacted by post and asked by the Director of Public Health to consent to receive a postal or electronic questionnaire about communicating their views to the NHS. Those who consented were then sent questionnaires. Response rates at both stages were measured. Results 25% of people returned signed consent forms and were invited to complete questionnaires. Respondents at the consent stage were more likely to be female (odds ratio (OR) response rate of women compared to men = 1.5, 95% CI 1.4, 1.7), less likely to live in deprived postal areas (OR = 0.59, 95% CI 0.45, 0.78) and more likely to be older (OR for people born in 1930–39 compared to people born in 1970–79 = 2.82, 95% CI 2.36, 3.37). 80% of people who were invited to complete questionnaires returned them. Response rates were higher among older age groups. The overall response rate to the survey was 20%, relative to the original number approached for consent (1951/10000). Conclusion The requirement of a separate, prior consent stage may significantly reduce overall survey response rates and necessitate the use of substantially larger initial samples for population surveys. It may also exacerbate non-response bias with respect to demographic variables. PMID:14622444

State Higher Education Systems and College Completion. Final Report to the Ford Foundation.

ERIC Educational Resources Information Center

Orfield, Gary; Paul, Faith G.

In response to data indicating that states having fewer post-secondary enrollees in two-year colleges had higher baccalaureate attainment, a study was undertaken to examine the possibility that a major state commitment to community colleges in response to demands for access means lower baccalaureate completion rates. The study compared Florida and…

Do the conventional clinicopathologic parameters predict for response and survival in head and neck cancer patients undergoing neoadjuvant chemotherapy?

PubMed

Fonseca, E; Cruz, J J; Dueñas, A; Gómez, A; Sánchez, P; Martín, G; Nieto, A; Soria, P; Muñoz, A; Gómez, J L; Pardal, J L

1996-01-01

Neoadjuvant chemotherapy for head and neck carcinoma is still an important treatment modality. The prognostic value of patient and tumor parameters has been extensively evaluated in several trials, yielding mixed results. We report the prognostic factors emerging from a group of patients undergoing neoadjuvant chemotherapy. From April 1986 to June 1992, 149 consecutive patients received cisplatin-5-fluorouracil-based neoadjuvant chemotherapy. After four courses of chemotherapy, patients underwent local-regional treatment with surgery, radiation or both. A variety of patient and tumor characteristics were evaluated as predictors for response to chemotherapy and survival. The complete response, partial response and no response rates to NAC were 52%, 33% and 15%, respectively. No parameters predicted response to chemotherapy. At a maximum follow-up of 87 months, overall survival was 39% and disease-free survival was 49%. Variables shown to be predictors of survival in univariate analyses were age, performance status, histology, site, T, N, stage, and response to chemotherapy. Using the Cox regression analysis, only complete response to induction chemotherapy (P = 0.0006), performance status (P = 0.03), stage (P = 0.01), age (P = 0.03) and primary tumor site (P = 0.04) emerged as independent prognostic factors for survival. Complete response to chemotherapy was confirmed as the strongest prognostic factor influencing survival. However, conventional clinicopathologic factors did not predict response, hence, potential prognostic biologic and molecular factors for response must be sought. At present, much effort must be made for the improvement of the complete response rate, which seems to be a requisite to prolong survival.

Web-Enhanced General Chemistry Increases Student Completion Rates, Success, and Satisfaction

ERIC Educational Resources Information Center

Amaral, Katie E.; Shank, John D.; Shibley, Ivan A., Jr.; Shibley, Lisa R.

2013-01-01

General Chemistry I historically had one of the highest failure and withdrawal rates at Penn State Berks, a four-year college within the Penn State system. The course was completely redesigned to incorporate more group work, the use of classroom response systems, peer mentors, and a stronger online presence via the learning management system…

Community College Responses to Calls for Higher Completion Rates: The Cases of Three Community Colleges

ERIC Educational Resources Information Center

Smock, Elizabeth S.

2013-01-01

The primary purpose of this study was to understand how three diverse community colleges are interpreting and acting on federal initiatives to increase completion rates. The study attempted to answer four main research questions: (1) How do a selection of Kansas community colleges, as organizations, interpret the initiative to increase completion…

Individualized Radiation Dose Escalation Based on the Decrease in Tumor FDG Uptake and Normal Tissue Constraints Improve Survival in Patients With Esophageal Carcinoma.

PubMed

Ma, Jinbo; Wang, Zhaoyang; Wang, Chengde; Chen, Ercheng; Dong, Yaozong; Song, Yipeng; Wang, Wei; You, Dong; Jiang, Wei; Zang, Rukun

2017-02-01

To determine whether individualized radiation dose escalation after planned chemoradiation based on the decrease in tumor and normal tissue constraints can improve survival in patients with esophageal carcinoma. From August 2005 to December 2010, 112 patients with squamous esophageal carcinoma were treated with radical concurrent chemoradiation. Patients received positron emission tomography-computer tomography scan twice, before radiation and after radiation dose of 50.4 Gy. All patients were noncomplete metabolic response groups according to the Response Evaluation Criteria in solid tumors. Only 52 patients with noncomplete metabolic response received individualized dose escalation based on tumor and normal tissue constraints. Survival and treatment failure were observed and analyzed using SPSS (13.0). The rate of complete metabolic response for patients with noncomplete metabolic response after dose escalation reached 17.3% (9 of 52). The 2-year overall survival rates for patients with noncomplete metabolic response in the conventional and dose-escalation groups were 20.5% and 42.8%, respectively( P = .001). The 2-year local control rates for patients were 35.7% and 76.2%, respectively ( P = .002). When patients were classified into partial metabolic response and no metabolic response, 2-year overall survival rates for patients with partial metabolic response were significantly different in conventional and dose-escalation groups (33.8% vs 78.4%; P = .000). The 2-year overall survival rates for patients with no metabolic response in two groups (8.6% vs 15.1%) did not significantly differ ( P = .917). Individualized radiation dose escalation has the potential to improve survival in patients with esophageal carcinoma according to increased rate of complete metabolic response. However, further trials are needed to confirm this and to identify patients who may benefit from dose escalation.

Influence of paper color and a monetary incentive on response rate.

PubMed

King, Keith A; Vaughan, Jennifer L

2004-10-01

This study examined whether survey response rate differed based on the color of the paper the survey was printed on (blue vs green) and presence of a monetary incentive. A 4-page survey on eating disorders was mailed to Division 1A and 1AA college head athletic trainers (N=223) with half of the surveys on blue paper and half on green paper. Half of the athletic trainers (n = 111) received a $1.00 monetary incentive, and half (n = 112) received no monetary incentive. A total of 166 (71%) athletic trainers returned completed surveys. Response rates did not differ based on survey color but did differ based on presence of a monetary incentive. Athletic trainers who received a monetary incentive were significantly more likely than those who did not to return completed surveys (86% vs 63%, respectively).

Social Reinforcement Delays in Free-Flying Honey Bees (Apis mellifera L.)

PubMed Central

Craig, David Philip Arthur; Grice, James W.; Varnon, Chris A.; Gibson, B.; Sokolowski, Michel B. C.; Abramson, Charles I.

2012-01-01

Free-flying honey bees (Apis mellifera L.) reactions were observed when presented with varying schedules of post-reinforcement delays of 0 s, 300 s, or 600 s. We measured inter-visit-interval, response length, inter-response-time, and response rate. Honey bees exposed to these post-reinforcement delay intervals exhibit one of several patterns compared to groups not encountering delays, and had longer inter-visit-intervals. We observed no group differences in inter-response time. Honey bees with higher response rates tended to not finish the experiment. The removal of the delay intervals increased response rates for those subjects that completed the trials. PMID:23056425

Who sends the email? Using electronic surveys in violence research.

PubMed

Sutherland, Melissa A; Amar, Angela F; Laughon, Kathryn

2013-08-01

Students aged 16-24 years are at greatest risk for interpersonal violence and the resulting short and long-term health consequences. Electronic survey methodology is well suited for research related to interpersonal violence. Yet methodological questions remain about best practices in using electronic surveys. While researchers often indicate that potential participants receive multiple emails as reminders to complete the survey, little mention is made of the sender of the recruitment email. The purpose of this analysis is to describe the response rates from three violence-focused research studies when the recruitment emails are sent from a campus office, researcher or survey sampling firm. Three violence-focused studies were conducted about interpersonal violence among college students in the United States. Seven universities and a survey sampling firm were used to recruit potential participants to complete an electronic survey. The sender of the recruitment emails varied within and across the each of the studies depending on institutional review boards and university protocols. An overall response rate of 30% was noted for the 3 studies. Universities in which researcher-initiated recruitment emails were used had higher response rates compared to universities where campus officials sent the recruitment emails. Researchers found lower response rates to electronic surveys at Historically Black Colleges or Universities and that other methods were needed to improve response rates. The sender of recruitment emails for electronic surveys may be an important factor in response rates for violence-focused research. For researchers identification of best practices for survey methodology is needed to promote accurate disclosure and increase response rates.

Pathological response to neoadjuvant chemotherapy: a new prognosis tool for the curative management of peritoneal colorectal carcinomatosis.

PubMed

Passot, Guillaume; You, Benoît; Boschetti, Gilles; Fontaine, Juliette; Isaac, Sylvie; Decullier, Evelyne; Maurice, Christele; Vaudoyer, Delphine; Gilly, François-Noël; Cotte, Eddy; Glehen, Olivier

2014-08-01

The primary objective of this study was to determine the incidence rate of pathological complete responses (pCRs) following neoadjuvant systemic chemotherapy for the treatment of peritoneal carcinomatosis (PC) of colorectal origin. The secondary objective was to evaluate whether pathological response assessments predict survival of patients treated with curative intent by complete cytoreductive surgery (CRS). A retrospective review was performed of 115 patients who underwent preoperative irinotecan- or oxaliplatin-based chemotherapy, followed by 124 procedures of complete CRS alone or combined with hyperthermic intraperitoneal chemotherapy (HIPEC). The pathological response was defined as the mean percentage of cancer cells remaining within all specimens. Univariate and multivariate analyses were performed to identify predictors of survival and pathological response outcome. Twelve procedures (9.7 %) resulted in pCRs, defined as no residual cancer cells in all specimens, 25 (20.2 %) resulted in major responses (1 to 49 % residual cancer cells), and 87 (70.1 %) resulted in minor or no responses (>50 % residual cancer cells). The cumulative 5-year survival rates were 75 and 57 % for patients with pCR and major responses, respectively. Using multivariate analysis, pathological response was the only independent predictor of survival (P = 0.01; major response: hazard ratio [HR] = 4.91; minor response: HR = 13.46). No significant predictor of pathological response was identified. Pathological complete response can be achieved with preoperative systemic chemotherapy for patients with PC of colorectal origin. The degree of pathological response can be assessed and represented as a new outcome for prognosis following treatment with curative intent.

Use of monetary and nonmonetary incentives to increase response rates among African Americans in the Wisconsin Pregnancy Risk Assessment Monitoring System.

PubMed

Dykema, Jennifer; Stevenson, John; Kniss, Chad; Kvale, Katherine; González, Kim; Cautley, Eleanor

2012-05-01

From 2009 to 2010, an experiment was conducted to increase response rates among African American mothers in the Wisconsin Pregnancy Risk Assessment Monitoring System (PRAMS). Sample members were randomly assigned to groups that received a prepaid, cash incentive of $5 (n = 219); a coupon for diapers valued at $6 (n = 210); or no incentive (n = 209). Incentives were included with the questionnaire, which was mailed to respondents. We examined the effects of the incentives on several outcomes, including response rates, cost effectiveness, survey response distributions, and item nonresponse. Response rates were significantly higher for the cash group than for the coupon (42.5 vs. 32.4%, P < .05) or no incentive group (42.5 vs. 30.1%, P < .01); the coupon and no incentive groups performed similarly. While absolute costs were the highest for the cash group, the cost per completed survey was the lowest. The incentives had limited effects on response distributions for specific survey questions. Although respondents completing the survey by mail in the cash and coupon groups exhibited a trend toward being less likely to have missing data, the effect was not significant. Compared to a coupon or no incentive, a small cash incentive significantly improved response rates and was cost effective among African American respondents in Wisconsin PRAMS. Incentives had only limited effects, however, on survey response distributions, and no significant effects on item nonresponse.

Efficacy of TACE in TIPS Patients: Comparison of Treatment Response to Chemoembolization for Hepatocellular Carcinoma in Patients With and Without a Transjugular Intrahepatic Portosystemic Shunt

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

Kuo, Yuo-Chen, E-mail: yuo-chen.kuo@ucsf.edu; Kohi, Maureen P., E-mail: maureen.kohi@ucsf.edu; Naeger, David M., E-mail: david.naeger@ucsf.edu

Purpose: To compare treatment response after transarterial chemoembolization (TACE) for hepatocellular carcinoma (HCC) in patients with and without a transjugular intrahepatic portosystemic shunt (TIPS). Materials and Methods: A retrospective review of patients who underwent conventional TACE for HCC between January 2005 and December 2009 identified 10 patients with patent TIPS. From the same time period, 23 patients without TIPS were selected to control for comparable Model for End-Stage Liver Disease and Child-Pugh-Turcotte scores. The two groups showed similar distribution of Barcelona Clinic Liver Cancer and United Network of Organ Sharing stages. Target HCC lesions were evaluated according to the modifiedmore » response evaluation criteria in solid tumors (mRECIST) guidelines. Transplantation rate, time to tumor progression, and overall survival (OS) were documented. Results: After TACE, the rate of complete response was significantly greater in non-TIPS patients compared with TIPS patients (74 vs. 30 %, p = 0.03). Objective response rate (complete and partial response) trended greater in the non-TIPS group (83 vs. 50 %, p = 0.09). The liver transplantation rate was 80 and 74 % in the TIPS and non-TIPS groups, respectively (p = 1.0). Time to tumor progression was similar (p = 0.47) between the two groups. OS favored the non-TIPS group (p = 0.01) when censored for liver transplantation. Conclusion: TACE is less effective in achieving complete or partial response using mRECIST criteria in TIPS patients compared with those without a TIPS. Nevertheless, similar clinical outcomes may be achieved, particularly in TIPS patients who are liver-transplantation candidates.« less

Concurrent IMRT and weekly cisplatin followed by GDP chemotherapy in newly diagnosed, stage IE to IIE, nasal, extranodal NK/T-Cell lymphoma.

PubMed

Ke, Q-H; Zhou, S-Q; Du, W; Liang, G; Lei, Y; Luo, F

2014-12-12

On the basis of the benefits of frontline radiation in early-stage, extranodal natural killer (NK)/T-cell lymphoma (ENKTL), we conducted the trial of concurrent chemoradiotherapy (CCRT) followed by three cycles of gemcitabine, dexamethasone and cisplatin (GDP). Thirty-two patients with newly diagnosed, stage IE to IIE, nasal ENKTL received CCRT (that is, all patients received intensity-modulated radiotherapy 56 Gy and cisplatin 30 mg/m(2) weekly, 3-5 weeks). Three cycles of GDP (gemcitabine 1000 mg/m(2) intravenously (i.v.) on days 1 and 8, dexamethasone 40 mg orally on days 1-4 and cisplatin 75 mg/m(2) i.v. on day 1 (GDP), every 21 days as an outpatient were scheduled after CCRT. All patients completed CCRT, which resulted in 100% response that included 24 complete responses (CRs) and eight partial responses. The CR rate after CCRT was 75.0% (that is, 24 of 32 responses). Twenty-eight of the 32 patients completed the planned three cycles of GDP, whereas four patients did not because they withdrew (n = 1) or because they had an infection (n = 3). The overall response rate and the CR rate were 90.6% (that is, 29 of 32 responses) and 84.4% (that is, 27 of 32 responses), respectively. Only two patient experienced grade 3 toxicity during CCRT (nausea), whereas 13 of the 30 patients experienced grade 4 neutropenia. The estimated 3-year overall survival and progression-free rates were 87.50% and 84.38%, respectively. In conclusion, CCRT followed by GDP chemotherapy can be a feasible and effective treatment strategy for stage IE to IIE nasal ENKTL.

Hyberbaric oxygen as sole treatment for severe radiation - induced haemorrhagic cystitis

PubMed Central

Dellis, Athanasios; Papatsoris, Athanasios; Kalentzos, Vasileios; Deliveliotis, Charalambos; Skolarikos, Andreas

2017-01-01

ABSTRACT Purpose To examine the safety and efficacy of hyperbaric oxygen as the primary and sole treatment for severe radiation-induced haemorrhagic cystitis. Materials and methods Hyperbaric oxygen was prospectively applied as primary treatment in 38 patients with severe radiation cystitis. Our primary endpoint was the incidence of complete and partial response to treatment, while the secondary endpoints included the duration of response, the correlation of treatment success-rate to the interval between the onset of haematuria and initiation of therapy, blood transfusion need and total radiation dose, the number of sessions to success, the avoidance of surgery and the overall survival. Results All patients completed therapy without complications with a mean follow-up of 29.33 months. Median number of sessions needed was 33. Complete and partial response rate was 86.8% and 13.2%, respectively. All 33 patients with complete response received therapy within 6 months of the haematuria onset. One patient needed cystectomy, while 33 patients were alive at the end of follow-up. Conclusions Our study suggests the early primary use of hyperbaric oxygen for radiation-induced severe cystitis as an effective and safe treatment option. PMID:28338304

Comparison of content of FDA letters not approving applications for new drugs and associated public announcements from sponsors: cross sectional study

PubMed Central

Chahal, Harinder S; Sigelman, Daniel W; Stacy, Sylvie; Sclar, Joshua; Ddamulira, Barbara

2015-01-01

Objectives To describe the content of non-public complete response letters issued by the US Food and Drug Administration (FDA) when they do not approve marketing applications from sponsors (drug companies) and to compare them with the content any subsequent press releases issued by those sponsors Design Cross sectional study. Data sources All applications for which FDA’s Center for Drug Evaluation and Research initially issued complete response letters (n=61) from 11 August 2008 to 27 June 2013. Complete response letters and press releases were divided into discrete statements related to seven domains and 64 subdomains and assessed to determine whether they matched. Results 48% (29) of complete response letters cited deficiencies in both the safety and efficacy domains, and only 13% cited neither safety nor efficacy deficiencies. No press release was issued for 18% (11) of complete response letters, and 21% (13) of press releases did not match any statements from the letters. Press release statements matched 93 of the 687 statements (14%), including 16% (30/191) of efficacy and 15% (22/150) of safety statements. Of 32 complete response letters that called for a new clinical trial for safety or efficacy, 59% (19) had matching press release statements. Seven complete response letters reported higher mortality rates in treated participants; only one associated press release mentioned this fact. Conclusions FDA generally issued complete response letters to sponsors for multiple substantive reasons, most commonly related to safety and/or efficacy deficiencies. In many cases, press releases were not issued in response to those letters and, when they were, omitted most of the statements in the complete response letters. Press releases are incomplete substitutes for the detailed information contained in complete response letters. PMID:26063327

Assessment of fludarabine plus cyclophosphamide for patients with chronic lymphocytic leukaemia (the LRF CLL4 Trial): a randomised controlled trial.

PubMed

Catovsky, D; Richards, S; Matutes, E; Oscier, D; Dyer, M J S; Bezares, R F; Pettitt, A R; Hamblin, T; Milligan, D W; Child, J A; Hamilton, M S; Dearden, C E; Smith, A G; Bosanquet, A G; Davis, Z; Brito-Babapulle, V; Else, M; Wade, R; Hillmen, P

2007-07-21

Previous studies of patients with chronic lymphocytic leukaemia reported high response rates to fludarabine combined with cyclophosphamide. We aimed to establish whether this treatment combination provided greater survival benefit than did chlorambucil or fludarabine. 777 patients with chronic lymphocytic leukaemia requiring treatment were randomly assigned to fludarabine (n=194) or fludarabine plus cyclophosphamide (196) for six courses, or chlorambucil (387) for 12 courses. The primary endpoint was overall survival, with secondary endpoints of response rates, progression-free survival, toxic effects, and quality of life. Analysis was by intention to treat. This study is registered as an International Standard Randomised Controlled Trial, number NCT 58585610. There was no significant difference in overall survival between patients given fludarabine plus cyclophosphamide, fludarabine, or chlorambucil. Complete and overall response rates were better with fludarabine plus cyclophosphamide than with fludarabine (complete response rate 38%vs 15%, respectively; overall response rate 94%vs 80%, respectively; p<0.0001 for both comparisons), which were in turn better than with chlorambucil (complete response rate 7%, overall response rate 72%; p=0.006 and 0.04, respectively). Progression-free survival at 5 years was significantly better with fludarabine plus cyclophosphamide (36%) than with fludarabine (10%) or chlorambucil (10%; p<0.00005). Fludarabine plus cyclophosphamide was the best combination for all ages, including patients older than 70 years, and in prognostic groups defined by immunoglobulin heavy chain gene (V(H)) mutation status and cytogenetics, which were tested in 533 and 579 cases, respectively. Patients had more neutropenia and days in hospital with fludarabine plus cyclophosphamide, or fludarabine, than with chlorambucil. There was less haemolytic anaemia with fludarabine plus cyclophosphamide (5%) than with fludarabine (11%) or chlorambucil (12%). Quality of life was better for responders, but preliminary analyses showed no significant difference between treatments. A meta-analysis of these data and those of two published phase III trials showed a consistent benefit for the fludarabine plus cyclophosphamide regimen in terms of progression-free survival. Fludarabine plus cyclophosphamide should now become the standard treatment for chronic lymphocytic leukaemia and the basis for new protocols that incorporate monoclonal antibodies.

Remote Collection of Patient-Reported Outcomes Following Outpatient Hand Surgery: A Randomized Trial of Telephone, Mail, and E-Mail.

PubMed

Schwartzenberger, Justin; Presson, Angela; Lyle, Adam; O'Farrell, Andrew; Tyser, Andrew R

2017-09-01

Obtaining remote patient-reported outcomes (PRO) is limited by low patient response rates and resource-intensive collection methods. We hypothesized that an e-mail-delivered Web-based data collection tool would outperform the traditional methods of telephone and standard mail for collecting long-term Boston Carpal Tunnel Questionnaire (BCTQ) scores at a minimum of 1 year following carpal tunnel release (CTR). We conducted a randomized trial of 969 patients who underwent CTR at a tertiary medical center within the past 5 years. Participants were randomized to the PRO collection methods of mail, telephone, and e-mail. The primary outcome was survey response rate at 1 year after surgery. Secondary analyses included data completeness and the effect of time from surgery, mode effects, and patient modality preference. At 1 year from surgery, the response rates were 64% for telephone and 42% for both mail and e-mail. Ninety-nine percent of telephone surveys were complete compared with 88% and 83% for mail and e-mail, respectively. There was no significant difference in the overall response rate at 1 or 5 years after surgery, nor in the BCTQ score between the modalities. A higher response rate and increased survey completeness was achieved by telephone contact methods compared with standard mailings or Web-based methods for PRO collection after CTR 1 to 5 years after surgery. A Web-based method demonstrated response rates equivalent to those of standard mail, was the most preferred modality, and offered logistical advantages such as automation and immediate integration with outcome databases. Obtaining PRO routinely after treatment may increase in importance. A Web-based interface may assist clinicians in decreasing the resource utilization typically associated with more traditional methods used to obtain outcome data. Copyright © 2017 American Society for Surgery of the Hand. Published by Elsevier Inc. All rights reserved.

Essential thrombocythemia: response during first year of therapy with melphalan and radioactive phosphorus: a polycythemia Vera Study Group report

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

Murphy, S.; Rosenthal, D.S.; Weinfeld, A.

1982-07-01

Thirty-one patients with essential thrombocythemia were randomized to receive either melphalan or radioactive phosphorus as myelosuppressive therapy. Twenty-seven patients were evaluable for response. Of 13 patients treated with melphalan, 11 had a complete response (platelet count less than 450,000/mm3) at 3 and 6 months. This response rate was significantly better than the response to radioactive phosphorus. The response rates were similar at 12 months. No significant toxicity was observed with either regimen.

Peritoneal dialysis-related peritonitis caused by Pseudomonas species: Insight from a post-millennial case series.

PubMed

Lu, Wanhong; Kwan, Bonnie Ching-Ha; Chow, Kai Ming; Pang, Wing-Fai; Leung, Chi Bon; Li, Philip Kam-To; Szeto, Cheuk Chun

2018-01-01

Pseudomonas peritonitis is a serious complication of peritoneal dialysis (PD). However, the clinical course of Pseudomonas peritonitis following the adoption of international guidelines remains unclear. We reviewed the clinical course and treatment response of 153 consecutive episodes of PD peritonitis caused by Pseudomonas species from 2001 to 2015. Pseudomonas peritonitis accounted for 8.3% of all peritonitis episodes. The bacteria isolated were resistant to ceftazidime in 32 cases (20.9%), and to gentamycin in 18 cases (11.8%). In 20 episodes (13.1%), there was a concomitant exit site infection (ESI); in another 24 episodes (15.7%), there was a history of Pseudomonas ESI in the past. The overall primary response rate was 53.6%, and complete cure rate 42.4%. There was no significant difference in the complete cure rate between patients who treated with regimens of 3 and 2 antibiotics. Amongst 76 episodes (46.4%) that failed to respond to antibiotics by day 4, 37 had immediate catheter removal; the other 24 received salvage antibiotics, but only 6 achieved complete cure. Antibiotic resistance is common amongst Pseudomonas species causing peritonitis. Adoption of the treatment guideline leads to a reasonable complete cure rate of Pseudomonas peritonitis. Treatment with three antibiotics is not superior than the conventional two antibiotics regimen. When there is no clinical response after 4 days of antibiotic treatment, early catheter removal should be preferred over an attempt of salvage antibiotic therapy.

Long-Term Outcomes Among Patients Who Achieve Complete or Near-Complete Responses After the Induction Phase of Bladder-Preserving Combined-Modality Therapy for Muscle-Invasive Bladder Cancer: A Pooled Analysis of NRG Oncology/RTOG 9906 and 0233

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

Mitin, Timur, E-mail: mitin@ohsu.edu; George, Asha; Zietman, Anthony L.

Purpose: To investigate the differences in outcomes among patients with muscle-invasive bladder cancer on NRG Oncology Radiation Therapy Oncology Group protocols 9906 and 0233 who achieved complete response and near-complete response after induction chemoradiation and then completed bladder-preserving therapy with chemoradiation therapy (chemo-RT) to full dose (60-64 Gy). Patients and Methods: A pooled analysis was performed on 119 eligible patients with muscle-invasive bladder cancer enrolled on NRG Oncology Radiation Therapy Oncology Group trials 9906 and 0233, who were classified as having a complete (T0) or near-complete (Ta or Tis) response after induction chemo-RT and completed consolidation with a total RT dose ofmore » at least 60 Gy. Bladder recurrence, salvage cystectomy rates, and disease-specific survival were estimated by the cumulative incidence method and bladder-intact and overall survivals by the Kaplan-Meier method. Results: Among the 119 eligible patients, 101 (85%) achieved T0, and 18 (15%) achieved Ta or Tis after induction chemo-RT and proceeded to consolidation. After a median follow-up of 5.9 years, 36 of 101 T0 patients (36%) versus 5 of 18 Ta or Tis patients (28%) experienced bladder recurrence (P=.52). Thirteen patients among complete responders eventually required late salvage cystectomy for tumor recurrence, compared with 1 patient among near-complete responders (P=.63). Disease-specific, bladder-intact, and overall survivals were not significantly different between T0 and Ta/Tis cases. Conclusions: The bladder recurrence and salvage cystectomy rates of the complete and the near-complete responders were similar. Therefore it is reasonable to recommend that patients with Ta or Tis after induction chemo-RT continue with bladder-sparing therapy with consolidation chemo-RT to full dose (60-64 Gy).« less

Using Norm-Based Appeals to Increase Response Rates in Evaluation Research: A Field Experiment

ERIC Educational Resources Information Center

Misra, Shalini; Stokols, Daniel; Marino, Anne Heberger

2012-01-01

A field experiment was conducted to test the effectiveness of norm-based persuasive messages for increasing response rates in online survey research. Participants in an interdisciplinary conference were asked to complete two successive postconference surveys and randomly assigned to one of two groups at each time point. The experimental group…

A Mixed-Methods Investigation of Factors and Scenarios Influencing College Students' Decision to Complete Surveys at Five Mid-Western Universities

ERIC Educational Resources Information Center

Koskey, Kristin L. K.; Cain, Bryce; Sondergeld, Toni A.; Alvim, Henrique G.; Slager, Emily M.

2015-01-01

Achieving respectable response rates to surveys on university campuses has become increasingly more difficult, which can increase non-response error and jeopardize the integrity of data. Prior research has focused on investigating the effect of a single or small set of factors on college students' decision to complete surveys. We used a concurrent…

Effects of Differential Reinforcement of Short Latencies on Response Latency, Task Completion, and Accuracy of an Adolescent with Autism

ERIC Educational Resources Information Center

Donohue, Melanie M.; Casey, Laura Baylot; Bicard, David F.; Bicard, Sara E.

2012-01-01

Children with Autism Spectrum Disorder (ASD) are faced with many challenging behaviors that could impede their learning. One commonly reported problem behavior is noncompliance, which is often defined as a delay in response (latency), decrease in rate of responding (fluency), or failure to complete a task. This failure to comply in an appropriate…

Photodynamic therapy with 5-aminoolevulinic acid-induced porphyrins and DMSO/EDTA for basal cell carcinoma

NASA Astrophysics Data System (ADS)

Warloe, Trond; Peng, Qian; Heyerdahl, Helen; Moan, Johan; Steen, Harald B.; Giercksky, Karl-Erik

1995-03-01

Seven hundred sixty three basal cell carcinomas (BCCs) in 122 patients were treated by photodynamic therapy by 5-aminolevulinic acid (ALA) in cream topically applied, either alone, in combination with dimethyl sulphoxide (DMSO) and ethylenediaminetetraacetic acid disodium salt (EDTA), or with DMSO as a pretreatment. After 3 hours cream exposure 40 - 200 Joules/cm2 of 630 nm laser light was given. Fluorescence imaging of biopsies showed highly improved ALA penetration depth and doubled ALA-induced porphyrin production using DMSO/EDTA. Treatment response was recorded after 3 months. After a single treatment 90% of 393 superficial lesions responded completely, independent of using DMSO/EDTA. In 363 nodulo-ulcerative lesions the complete response rate increased from 67% to above 90% with DMSO/EDTA for lesions less than 2 mm thickness and from 34% to about 50% for lesions thicker than 2 mm. Recurrence rate observed during a follow-up period longer than 12 months was 2 - 5%. PDT of superficial thin BCCs with ALA-induced porphyrins and DMSO/EDTA equals surgery and radiotherapy with respect to cure rate and recurrence. Cosmetic results of ALA-based PDT seemed to be better than those after other therapies. In patients with the nevoid BCC syndrome the complete response rate after PDT was far lower.

Staff Judgements of Responsibility for the Challenging Behaviour of Adults with Intellectual Disabilities

ERIC Educational Resources Information Center

Dagnan, D.; Cairns, M.

2005-01-01

This study examines the importance of staff judgements of responsibility for challenging behaviour in predicting their emotional and intended helping responses. Sixty-two carers completed questionnaires rating attributions of internality, stability and controllability, emotions of sympathy and anger, judgements of responsibility for the…

Efficacy of Skin-Directed Therapy for Cutaneous Metastases From Advanced Cancer: A Meta-Analysis

PubMed Central

Spratt, Daniel E.; Gordon Spratt, Elizabeth A.; Wu, Shenhong; DeRosa, Antonio; Lee, Nancy Y.; Lacouture, Mario E.; Barker, Christopher A.

2014-01-01

Purpose To perform the first meta-analysis of the efficacy of skin-directed therapies for cutaneous metastases. Methods MEDLINE, EMBASE, The Cochrane Library, and ClinicalTrials.gov databases were searched for reports of prospective clinical studies published between 1960 and 2013 that assessed the response of skin-directed therapy for cutaneous metastases (47 of 2,955 unique studies were selected). Primary end points of the study were complete and objective response rates. Secondary analyses were preplanned and included subgroup analyses by skin-directed therapy, histology, and recurrence rates. Meta-analyses were performed with random-effect modeling, and extent of heterogeneity between studies was determined with the Cochran Q and I2 tests. Results After applying exclusion criteria, 47 prospective studies of 4,313 cutaneous metastases were assessed. Five skin-directed therapies were identified: electrochemotherapy, photodynamic therapy, radiotherapy, intralesional therapy, and topical therapy. Among all cutaneous metastases, complete response rate was 35.5% (95% CI, 27.6% to 44.3%) and objective response rate was 60.2% (95% CI, 50.6% to 69.0%). Overall recurrence rate was estimated to be 9.2% (95% CI, 3.7% to 21.2%). Melanoma and breast carcinoma comprised 96.8% of all cutaneous metastases studied and had similar objective response rates (54.5% [95% CI, 48.3% to 60.7%] and 54.0% [95% CI, 48.3% to 59.7%], respectively). Grade ≥ 3 toxicity was reported in less than 6% of patients. Conclusion Response to skin-directed therapy for cutaneous metastases is high but heterogeneous across treatment modalities, with low rates of recurrence post-treatment. Treatment was generally well tolerated and conferred improvements in quality of life. Standardization of response criteria for cutaneous metastases and treatment algorithms to optimally use the available skin-directed therapies are needed. PMID:25154827

Phase 2 trial of neoadjuvant chemotherapy and transoral endoscopic surgery with risk-adapted adjuvant therapy for squamous cell carcinoma of the head and neck.

PubMed

Weiss, Jared M; Grilley-Olson, Juneko E; Deal, Allison Mary; Zevallos, Jose P; Chera, Bhishamjit S; Paul, Jennifer; Knowles, Mary Fleming; Usenko, Dmitriy; Weissler, Mark C; Patel, Samip; Hayes, David N; Hackman, Trevor

2018-05-09

The objective of this study was to demonstrate the feasibility and efficacy of induction chemotherapy, surgery, and pathology-guided adjuvant therapy to treat transorally resectable squamous head and neck cancer. Patients had squamous head and neck cancer that was resectable by the transoral route and advanced-stage disease (American Joint Committee on Cancer stage III-IV, T3-T4 tumors, and/or positive lymph nodes). They received treatment with weekly carboplatin at an area under the curve of 2, plus paclitaxel 135 mg/m 2 , and daily lapatinib 1000mg for 6 weeks followed by surgical resection. Pathology that revealed margins <5 mm, extracapsular extension, N2a of N2b lymph node status, perineural invasion, or lymphovascular space invasion resulted in adjuvant radiotherapy concurrent with weekly cisplatin. Pathology with N2c/N3 lymph node status or positive margins resulted in radiation with bolus cisplatin. The primary endpoint was the clinical response rate to induction chemotherapy, and a key secondary endpoint was feasibility. Toxicity was modest, and 37 of 40 patients completed study procedures as planned. The clinical response rate was 93%, the pathologic complete response rate was 36%, and the clinical response did not predict for a pathologic complete response. No patient on study follow-up has recurred or died. Twenty-nine of 39 patients who underwent surgery avoided radiation. Speech and swallowing function were well preserved. The study met both its primary efficacy endpoint and the secondary feasibility endpoint. Neoadjuvant, systemic therapy and surgical resection followed by risk-adapted adjuvant therapy resulted in high response rates and excellent long-term outcomes and should be further studied. Cancer 2018. © 2018 American Cancer Society. © 2018 American Cancer Society.

Comparison on Response and Dissolution Rates Between Ursodeoxycholic Acid Alone or in Combination With Chenodeoxycholic Acid for Gallstone Dissolution According to Stone Density on CT Scan: Strobe Compliant Observation Study.

PubMed

Lee, Jae Min; Hyun, Jong Jin; Choi, In Young; Yeom, Suk Keu; Kim, Seung Young; Jung, Sung Woo; Jung, Young Kul; Koo, Ja Seol; Yim, Hyung Joon; Lee, Hong Sik; Lee, Sang Woo; Kim, Chang Duck

2015-12-01

Medical dissolution of gallstone is usually performed on radiolucent gallstones in a functioning gallbladder. However, absence of visible gallstone on plain abdominal x-ray does not always preclude calcification. This study aims to compare the response and dissolution rates between ursodeoxycholic acid (UDCA) alone or in combination with chenodeoxycholic acid (CDCA) according to stone density on computed tomography (CT) scan. A total of 126 patients underwent dissolution therapy with either UDCA alone or combination of CDCA and UDCA (CNU) from December 2010 to March 2014 at Korea University Ansan Hospital. In the end, 81 patients (CNU group = 44, UDCA group = 37) completed dissolution therapy for 6 months. Dissolution rate (percentage reduction in the gallstone volume) and response to therapy (complete dissolution or partial dissolution defined as reduction in stone volume of >50%) were compared between the 2 groups. Dissolution and response rates of sludge was also compared between the 2 groups. The overall response rate was 50.6% (CNU group 43.2% vs UDCA group 59.5%, P = 0.14), and the overall dissolution rate was 48.34% (CNU group 41.5% vs UDCA group 56.5%, P = 0.13). When analyzed according to stone density, response rate was 33.3%, 87.1%, 30.0%, and 6.2% for hypodense, isodense, hyperdense, and calcified stones, respectively. Response rate (85.7% vs 88.2%, P = 0.83) and dissolution rate (81.01% vs 85.38%, P = 0.17) of isodense stones were similar between CNU and UDCA group. When only sludge was considered, the overall response rate was 87.5% (CNU group 71.4% vs UDCA group 94.1%, P = 0.19), and the overall dissolution rate was 85.42% (CNU group 67.9% vs UDCA group 92.7%, P = 0.23). Patients with isodense gallstones and sludge showed much better response to dissolution therapy with CNU and UDCA showing comparable efficacy. Therefore, CT scan should be performed before medication therapy if stone dissolution is intended.

Targeting Mutant BRAF in Relapsed or Refractory Hairy-Cell Leukemia.

PubMed

Tiacci, Enrico; Park, Jae H; De Carolis, Luca; Chung, Stephen S; Broccoli, Alessandro; Scott, Sasinya; Zaja, Francesco; Devlin, Sean; Pulsoni, Alessandro; Chung, Young R; Cimminiello, Michele; Kim, Eunhee; Rossi, Davide; Stone, Richard M; Motta, Giovanna; Saven, Alan; Varettoni, Marzia; Altman, Jessica K; Anastasia, Antonella; Grever, Michael R; Ambrosetti, Achille; Rai, Kanti R; Fraticelli, Vincenzo; Lacouture, Mario E; Carella, Angelo M; Levine, Ross L; Leoni, Pietro; Rambaldi, Alessandro; Falzetti, Franca; Ascani, Stefano; Capponi, Monia; Martelli, Maria P; Park, Christopher Y; Pileri, Stefano A; Rosen, Neal; Foà, Robin; Berger, Michael F; Zinzani, Pier L; Abdel-Wahab, Omar; Falini, Brunangelo; Tallman, Martin S

2015-10-29

BRAF V600E is the genetic lesion underlying hairy-cell leukemia. We assessed the safety and activity of the oral BRAF inhibitor vemurafenib in patients with hairy-cell leukemia that had relapsed after treatment with a purine analogue or who had disease that was refractory to purine analogues. We conducted two phase 2, single-group, multicenter studies of vemurafenib (at a dose of 960 mg twice daily)--one in Italy and one in the United States. The therapy was administered for a median of 16 weeks in the Italian study and 18 weeks in the U.S. study. Primary end points were the complete response rate (in the Italian trial) and the overall response rate (in the U.S. trial). Enrollment was completed (28 patients) in the Italian trial in April 2013 and is still open (26 of 36 planned patients) in the U.S. trial. The overall response rates were 96% (25 of 26 patients who could be evaluated) after a median of 8 weeks in the Italian study and 100% (24 of 24) after a median of 12 weeks in the U.S. study. The rates of complete response were 35% (9 of 26 patients) and 42% (10 of 24) in the two trials, respectively. In the Italian trial, after a median follow-up of 23 months, the median relapse-free survival was 19 months among patients with a complete response and 6 months among those with a partial response; the median treatment-free survival was 25 months and 18 months, respectively. In the U.S. trial, at 1 year, the progression-free survival rate was 73% and the overall survival rate was 91%. Drug-related adverse events were usually of grade 1 or 2, and the events most frequently leading to dose reductions were rash and arthralgia or arthritis. Secondary cutaneous tumors (treated with simple excision) developed in 7 of 50 patients. The frequent persistence of phosphorylated ERK-positive leukemic cells in bone marrow at the end of treatment suggests bypass reactivation of MEK and ERK as a resistance mechanism. A short oral course of vemurafenib was highly effective in patients with relapsed or refractory hairy-cell leukemia. (Funded by the Associazione Italiana per la Ricerca sul Cancro and others; EudraCT number, 2011-005487-13; ClinicalTrials.gov number NCT01711632.).

Design and rationale of the assessment of proper physiologic response with rate adaptive pacing driven by minute ventilation or accelerometer (APPROPRIATE) trial.

PubMed

Gilliam, F Roosevelt; Giudici, Michael; Benn, Andrew; Koplan, Bruce; Berg, Kellie Jean Chase; Kraus, Stacia Merkel; Stolen, Kira Q; Alvarez, Guy E; Hopper, Donald L; Wilkoff, Bruce L

2011-02-01

Rate-adaptive sensors are designed to restore a physiologic heart rate response to activity, in particular for patients that have chronotropic incompetence (CI). Limited data exist comparing two primary types of sensors; an accelerometer (XL) sensor which detects activity or motion and a minute ventilation (MV) sensor, which detects the product of respiration rate and tidal volume. The APPROPRIATE study will evaluate the MV sensor compared with the XL sensor for superiority in improving functional capacity (peak VO(2)) in pacemaker patients that have CI. This study is a double-blind, randomized, two-arm trial that will enroll approximately 1,000 pacemaker patients. Patients will complete a 6-min walk test at the 2-week visit to screen for potential CI. Those projected to have CI will advance to a 1-month visit. At the 1-month visit, final determination of CI will be done by completing a peak exercise treadmill test while the pacemaker is programmed to DDDR with the device sensors set to passive. Patients failing to meet the study criteria for CI will not continue further in the trial. Patients that demonstrate CI will be randomized to program their rate-adaptive sensors to either MV or XL in a 1:1 ratio. The rate-adaptive sensor will be optimized for each patient using a short walk to determine the appropriate response factor. At a 2-month visit, patients will complete a CPX test with the rate-adaptive sensors in their randomized setting.

D-cycloserine as an augmentation strategy of cognitive behavioral therapy for social anxiety disorder

PubMed Central

Hofmann, Stefan G.; Smits, Jasper A. J.; Rosenfield, David; Simon, Naomi; Otto, Michael W.; Meuret, Alicia E.; Marques, Luana; Fang, Angela; Tart, Candyce; Pollack, Mark H.

2014-01-01

OBJECTIVE To test whether d-cycloserine, a partial agonist at the glutamatergic N-methyl-D-aspartate receptor, augments and accelerates a full course of comprehensive cognitive behavioral therapy (CBT) in medication-free adults with generalized social anxiety disorder. METHOD A randomized placebo-controlled efficacy-study conducted at Boston University, Massachusetts General Hospital, and Southern Methodist University between 9/2007 and 12/2011 of 169 medication-free adults with generalized social anxiety disorder; 144 completed treatment, and 131 completed the follow-up assessments. Patients were randomized to receive 50 mg of d-cycloserine or placebo 1 hour before each of 5 exposure sessions that were part of a 12-session cognitive behavioral group treatment. Response and remission status was determined at baseline, throughout treatment, post-treatment, and at 1, 3, and 6-month follow-up assessments rated by assessors who were blind to treatment condition. RESULTS D-cycloserine-augmented and placebo-augmented CBT were associated with similar completion rates (87% and 82%), response rates (79.3% and 73.3%), and remission rates (34.5% and 24.4%) at post-treatment that were largely maintained at follow-up. Although d-cycloserine was associated with a 24–33% faster rate of improvement in symptom severity and remission rates relative to placebo during the 12-week treatment phase, the groups did not differ in response and remission rates. CONCLUSIONS D-cycloserine did not augment a full course of comprehensive CBT for social anxiety disorder. TRIAL REGISTRATION http://www.ClinicalTrials.gov, ID# NCT00633984, http://www.clinicaltrials.gov/ct2/show/NCT00633984 PMID:23599046

Topical agents for oral cancer chemoprevention: A systematic review of the literature.

PubMed

Chau, Lucy; Jabara, Justin T; Lai, Wanda; Svider, Peter F; Warner, Blake M; Lin, Ho-Sheng; Raza, S Naweed; Fribley, Andrew M

2017-04-01

We review the use of topical chemoprevention agents in patients with oral potentially malignant disorders (PMD). A systematic review of studies on topical chemoprevention agents for oral PMD from 1946 to November 2016 was conducted using the MEDLINE database, Embase, and Cochrane Library. Data were extracted and analyzed from selected studies including study type, sample size, demographics, treatment length, response rate, follow-up time, adverse effects, and recurrence. Of 108 studies, twenty-four, representing 679 cases met the inclusion criteria. The clinical lesions evaluated included oral leukoplakia, erythroplakia (OEL), verrucous hyperplasia (OVH), oral lichen planus, larynx squamous cell carcinoma, and oral squamous cell carcinoma (OSCC). The mean complete response rate for topical retinoid therapy was 32%. The mean complete response rate for 1% bleomycin therapy and 0.5% bleomycin was 40.2% and 25%, respectively. The complete response rate of OVH, OEL, and OSCC to photodynamic therapy ranged from 66.7% to 100%. There are a paucity of data examining topical treatment of oral PMDs. However, the use of topical agents among patients with oral lesions may be a viable complement or even alternative to traditional surgery, radiation, or systemic chemotherapy, with the advantage of reducing systemic side effects and sparing important anatomic structures. This study of 679 cases represents the largest pooled sample size to date, and the preliminary studies in this systematic review provide support for further inquiry. Copyright © 2017 Elsevier Ltd. All rights reserved.

Amifostine reduces side effects and improves complete response rate during radiotherapy: Results of a meta-analysis

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

Sasse, Andre Deeke; Gontijo de Oliveira Clark, Luciana; Sasse, Emma Chen

Purpose: To evaluate the efficacy of amifostine in diminishing radiotherapy side effects and whether or not it protects the tumor. Methods and Materials: We performed a systematic review and meta-analysis of 14 included randomized controlled trials, comprising 1451 patients, comparing the use of radiotherapy vs. radiotherapy plus amifostine for cancer treatment. Results: The use of amifostine significantly reduced the risk of developing mucositis (odds ratio [OR], 0.37; 95% confidence interval [CI], 0.29-0.48; p < 0.00001), esophagitis (OR, 0.38; CI, 0.26-0.54; p < 0.00001), acute xerostomia (OR, 0.24; CI, 0.15-0.36; p < 0.00001), late xerostomia (OR, 0.33; CI, 0.21-0.51; p

Initial nonresponse and survey response mode biases in survey research.

PubMed

Chi, Donald L; Chen, Chao Ying

2015-01-01

We evaluated survey response factors (particularly initial nonresponse and survey mode) that may be associated with bias in survey research. We examined prevention-related beliefs and outcomes for initial mail survey responders (n=209), follow-up mail survey responders (n=78), and follow-up telephone survey responders (n=74). The Pearson chi-square test and analysis of variance identified beliefs and behavioral outcomes associated with survey response mode. Follow-up options to the initial mail survey improved response rates (22.0-38.0 percent). Initial mail survey responders more strongly believed topical fluoride protects teeth from cavities than others (P=0.04). A significantly larger proportion of parents completing a follow-up telephone survey (30.8 percent) refused topical fluoride for their child than those completing mail surveys (10.3-10.4 percent) (P<0.0001). Multiple mode surveys with follow-up improve response rates. Initial nonresponse and survey response mode may be associated with biases in survey research. © 2015 American Association of Public Health Dentistry.

Cyclophosphamide, vincristine, methotrexate with leucovorin rescue, and cytarabine (COMLA) combination sequential chemotherapy for advanced diffuse histiocytic lymphoma

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

Sweet, D.L.; Golomb, H.M.; Ultmann, J.E.

A program of combination sequential chemotherapy using cyclophosphamide, vincristine, methotrexate with leucovorin rescue, and cytarabine (COMLA) was administered to 42 previously untreated patients with advanced diffuse histiocytic lymphoma. Twenty-three patients achieved a complete remission as determined by strict clinical restaging criteria. The observed median duration of survival for the complete responders is longer than 33 months. Eight patients achieved a partial response, with a median survival longer than 21 months. Eleven patients showed no response, with a median survival of 5 months. Toxicity was acceptable. None of the responders have shown central nervous system relapse. There was no difference inmore » response rates between patients with stage III or IV lymphoma or between asymptomatic or symptomatic patients. The COMLA program produces a high rate of complete and durable remissions and should be considered as an initial form of management of patients with advanced diffuse histiocytic lymphoma.« less

Development and validation of a brief general and sports nutrition knowledge questionnaire and assessment of athletes' nutrition knowledge.

PubMed

Trakman, Gina Louise; Forsyth, Adrienne; Hoye, Russell; Belski, Regina

2018-01-01

The Nutrition for Sport Knowledge Questionnaire (NSKQ) is an 89-item, valid and reliable measure of sports nutrition knowledge (SNK). It takes 25 min to complete and has been subject to low completion and response rates. The aim of this study was to develop an abridged version of the NSKQ (A-NSKQ) and compare response rates, completion rates and NK scores of the NSKQ and A-NSKQ. Rasch analysis was used for the questionnaire validation. The sample ( n  = 181) was the same sample that was used in the validation of the full-length NSKQ. Construct validity was assessed using the known-group comparisons method. Temporal stability was assessed using the test-retest reliability method. NK assessment was cross-sectional; responses were collected electronically from members of one non-elite Australian football (AF) and netball club, using Qualtrics Software (Qualtrics, Provo, UT). Validation - The A-NSKQ has 37 items that assess general ( n  = 17) and sports ( n  = 20) nutrition knowledge (NK). Both sections are unidimensional (Perc5% = 2.84% [general] and 3.41% [sport]). Both sections fit the Rasch Model (overall-interaction statistic mean (SD) = - 0.15 ± 0.96 [general] and 0.22 ± 1.11 [sport]; overall-person interaction statistic mean (SD) = - 0.11 ± 0.61 [general] and 0.08 ± 0.73 [sport]; Chi-Square probability = 0.308 [general] and 0.283 [sport]). Test-retest reliability was confirmed ( r  = 0.8, P  < 0.001 [general] and r  = 0.7, P < 0.001 [sport]). Construct validity was demonstrated (nutrition students = 77% versus non-nutrition students = 60%, P < 0.001 [general] and nutrition students = 60% versus non-nutrition students = 40%, P < 0.001 [sport]. Assessment of NK - 177 usable survey responses from were returned. Response rates were low (7%) but completion rates were high (85%). NK scores on the A-NSKQ (46%) are comparable to results obtained in similar cohorts on the NSKQ (49%). The A-NSKQ took on average 12 min to complete, which is around half the time taken to complete the NSKQ (25 min). The A-NSKQ is a valid and reliable, brief questionnaire designed to assess general NK (GNK) and SNK.

Six months versus nine months anti-tuberculous therapy for female genital tuberculosis: a randomized controlled trial.

PubMed

Sharma, Jai B; Singh, Neeta; Dharmendra, Sona; Singh, Urvashi B; P, Vanamail; Kumar, Sunesh; Roy, K K; Hari, Smriti; Iyer, V; Sharma, S K

2016-08-01

To compare six months versus nine months anti-tuberculous therapy in patients of female genital tuberculosis. It was a randomized controlled trial in a tertiary referral center teaching institute on 175 women presenting with infertility and found to have female genital tuberculosis on clinical examination and investigations. Group I women (86 women) were given 9 months of intermitted anti-tuberculous therapy under directly observed treatment short course (DOTS) strategy while Group II (89 women) were given 6 months of anti-tuberculous therapy under DOTS. Patients were evaluated for primary end points (complete cure, partial response, no response) and secondary end points (recurrence rate, pregnancy rate) during treatment. All patients were followed up further for one year after completion of therapy to assess recurrence of disease and further pregnancies. Baseline characteristics were similar between two randomized groups. There was no difference in the complete clinical response rate (95.3% vs 97.7%, p=0.441) between 9-months and 6-months groups. Four patients in 9-months group and two patients in 6-months group had recurrence of disease and required category II anti tuberculous therapy (p=0.441). Pregnancy rate during treatment and up to one year follow up was also similar in the two groups (23.2% vs 21.3%, p=0.762). Side effects occurred in 27(31.4%) and 29(32.6%) in 9-months and 6-months of therapy and were similar (p=0.866). There was no difference in complete cure rate, recurrent rate and pregnancy rate for either 6-months or 9-months of intermittent directly observed treatment short course anti-tuberculous therapy in female genital tuberculosis. The trial was registered in clinicaltrials.gov with registration no: CTRI/2009/091/001088. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

BiRD (Biaxin [clarithromycin]/Revlimid [lenalidomide]/dexamethasone) combination therapy results in high complete- and overall-response rates in treatment-naive symptomatic multiple myeloma.

PubMed

Niesvizky, Ruben; Jayabalan, David S; Christos, Paul J; Furst, Jessica R; Naib, Tara; Ely, Scott; Jalbrzikowski, Jessica; Pearse, Roger N; Zafar, Faiza; Pekle, Karen; Larow, April; Lent, Richard; Mark, Tomer; Cho, Hearn J; Shore, Tsiporah; Tepler, Jeffrey; Harpel, John; Schuster, Michael W; Mathew, Susan; Leonard, John P; Mazumdar, Madhu; Chen-Kiang, Selina; Coleman, Morton

2008-02-01

This trial determined the safety and efficacy of the combination regimen clarithromycin (Biaxin), lenalidomide (Revlimid), and dexamethasone (BiRD) as first-line therapy for multiple myeloma. Patients received BiRD in 28-day cycles. Dexamethasone (40 mg) was given orally once weekly, clarithromycin (500 mg) was given orally twice daily, and lenalidomide (25 mg) was given orally daily on days 1 to 21. Objective response was defined by standard criteria (ie, decrease in serum monoclonal protein [M-protein] by at least 50%, and a decrease in urine M-protein by at least 90%). Of the 72 patients enrolled, 65 had an objective response (90.3%). A combined stringent and conventional complete response rate of 38.9% was achieved, and 73.6% of the patients achieved at least a 90% decrease in M-protein levels. This regimen did not interfere with hematopoietic stem-cell harvest. Fifty-two patients who did not go on to receive transplants received continued therapy (complete response, 37%; very good partial response, 33%). The major adverse events were thromboembolic events, corticosteroid-related morbidity, and cytopenias. BiRD is an effective regimen with manageable side effects in the treatment of symptomatic, newly diagnosed multiple myeloma. This trial was registered at www.clinicaltrials.gov as #NCT00151203.

Data quality assurance: an analysis of patient non-response.

PubMed

Derby, Dustin C; Haan, Andrea; Wood, Kurt

2011-01-01

Patient satisfaction is paramount to maintaining high clinical quality assurance. This study seeks to compare response rates, response bias, and the completeness of data between paper and electronic collection modes of a chiropractic patient satisfaction survey. A convenience sample of 206 patients presenting to a chiropractic college clinic were surveyed concerning satisfaction with their chiropractic care. Paper (in-clinic and postal) and electronic modes of survey administration were compared for response rates and non-response bias. The online data collection mode resulted in fewer non-responses and a higher response rate, and did not evince response bias when compared to paper modes. The postal paper mode predicted non-response rates over the in-clinic paper and online modalities and exhibited a gender bias. This current study was a single clinic study; future studies should consider multi-clinic data collections. Busy clinic operations and available staff resources restricted the ability to conduct a random sampling of patients or to invite all eligible patients, therefore limiting the generalizability of collected survey data. Results of this study will provide data to aid development of survey protocols that efficiently, account for available human resources, and are convenient for patients while allowing for the most complete and accurate data collection possible in an educational clinic setting. Understanding patient responses across survey modes is critical for the cultivation of quality business intelligence within college teaching clinic settings. This study bridges measurement evidence from three popular data collection modalities and offers support for higher levels of quality for web-based data collection.

Treatment of Sézary Syndrome With Alemtuzumab: A Series of 5 Cases and a Review of the Literature.

PubMed

del Alcázar-Viladomiu, E; Tuneu-Valls, A; López-Pestaña, A; Vidal-Manceñido, M J

2015-09-01

Alemtuzumab is a monoclonal antibody that has been used to treat refractory cases of Sézary syndrome (SS) and advanced mycosis fungoides. We present 5 patients with SS who were treated with alemtuzumab between 2008 and 2012, with an overall response rate of 80% (40% partial response and 40% complete response). A regimen of 10mg administered subcutaneously was well tolerated with acceptable toxicity. The median duration of response was 13 months. However, one patient remains in complete remission after 67 months, a remarkable outcome given the low survival rate associated with SS. In conclusion, we believe that alemtuzumab may be useful in cases of SS refractory to other treatments. As there are no curative treatments for SS, alemtuzumab should be considered as a therapeutic option. Copyright © 2014 Elsevier España, S.L.U. y AEDV. All rights reserved.

Pre-notification letter type and response rate to a postal survey among women who have recently given birth.

PubMed

Todd, Angela L; Porter, Maree; Williamson, Jennifer L; Patterson, Jillian A; Roberts, Christine L

2015-12-01

Surveys are commonly used in health research to assess patient satisfaction with hospital care. Achieving an adequate response rate, in the face of declining trends over time, threatens the quality and reliability of survey results. This paper evaluates a strategy to increase the response rate in a postal satisfaction survey with women who had recently given birth. A sample of 2048 Australian women who had recently given birth at seven maternity units in New South Wales were invited to participate in a postal survey about their recent experiences with maternity care. The study design included a randomised controlled trial that tested two types of pre-notification letter (with or without the option of opting out of the survey). The study also explored the acceptability of a request for consent to link survey data with existing routinely collected health data (omitting the latter data items from the survey reduced survey length and participant burden). This consent was requested of all women. The survey had an overall response rate of 46% (913 completed surveys returned, total sample 1989). Women receiving the pre-notification letter with the option of opting out of the survey were more likely to actively decline to participate than women receiving the letter without this option, although the overall numbers of women declining were small (27 versus 12). Letter type was not significantly associated with the return of a completed survey. Among women who completed the survey, 97% gave consent to link their survey data with existing health data. The two types of pre-notification letters used in our study did not influence the survey response rate. However, seeking consent for record linkage was highly acceptable to women who completed the survey, and represents an important strategy to add to the arsenal for designing and implementing effective surveys. In addition to aspects of survey design, future research should explore how to more effectively influence personal constructs that contribute to the decision to participate in surveys.

Impact of different privacy conditions and incentives on survey response rate, participant representativeness, and disclosure of sensitive information: a randomized controlled trial.

PubMed

Murdoch, Maureen; Simon, Alisha Baines; Polusny, Melissa Anderson; Bangerter, Ann Kay; Grill, Joseph Patrick; Noorbaloochi, Siamak; Partin, Melissa Ruth

2014-07-16

Anonymous survey methods appear to promote greater disclosure of sensitive or stigmatizing information compared to non-anonymous methods. Higher disclosure rates have traditionally been interpreted as being more accurate than lower rates. We examined the impact of 3 increasingly private mailed survey conditions-ranging from potentially identifiable to completely anonymous-on survey response and on respondents' representativeness of the underlying sampling frame, completeness in answering sensitive survey items, and disclosure of sensitive information. We also examined the impact of 2 incentives ($10 versus $20) on these outcomes. A 3X2 factorial, randomized controlled trial of 324 representatively selected, male Gulf War I era veterans who had applied for United States Department of Veterans Affairs (VA) disability benefits. Men were asked about past sexual assault experiences, childhood abuse, combat, other traumas, mental health symptoms, and sexual orientation. We used a novel technique, the pre-merged questionnaire, to link anonymous responses to administrative data. Response rates ranged from 56.0% to 63.3% across privacy conditions (p = 0.49) and from 52.8% to 68.1% across incentives (p = 0.007). Respondents' characteristics differed by privacy and by incentive assignments, with completely anonymous respondents and $20 respondents appearing least different from their non-respondent counterparts. Survey completeness did not differ by privacy or by incentive. No clear pattern of disclosing sensitive information by privacy condition or by incentive emerged. For example, although all respondents came from the same sampling frame, estimates of sexual abuse ranged from 13.6% to 33.3% across privacy conditions, with the highest estimate coming from the intermediate privacy condition (p = 0.007). Greater privacy and larger incentives do not necessarily result in higher disclosure rates of sensitive information than lesser privacy and lower incentives. Furthermore, disclosure of sensitive or stigmatizing information under differing privacy conditions may have less to do with promoting or impeding participants' "honesty" or "accuracy" than with selectively recruiting or attracting subpopulations that are higher or lower in such experiences. Pre-merged questionnaires bypassed many historical limitations of anonymous surveys and hold promise for exploring non-response issues in future research.

Atezolizumab: A PD-L1-Blocking Antibody for Bladder Cancer.

PubMed

Inman, Brant A; Longo, Thomas A; Ramalingam, Sundhar; Harrison, Michael R

2017-04-15

Atezolizumab (Tecentriq, MPDL3280A; Genentech/Roche) is an FcγR binding-deficient, fully humanized IgG1 mAb designed to interfere with the binding of PD-L1 ligand to its two receptors, PD-1 and B7.1. By blocking the PD-L1/PD-1 immune checkpoint, atezolizumab reduces immunosuppressive signals found within the tumor microenvironment and, consequently, increases T-cell-mediated immunity against the tumor. Atezolizumab has been FDA approved as second-line therapy for advanced bladder cancer. This accelerated approval was based on phase II trial data in patients with metastatic bladder cancer that showed unexpected and durable tumor responses. In subjects whose tumors progressed on first-line platinum-based chemotherapy, the objective response rate was 15%, the complete response rate was 5%, and 1-year overall survival was 36%. In subjects that were chemotherapy naïve and cisplatin ineligible, the objective response rate was 24%, the complete response rate was 7%, and 1-year overall survival was 57%. Better responses were associated with higher PD-L1 expression on the tumor-infiltrating leukocytes. These data suggest that patients with advanced bladder cancer treated with atezolizumab have significantly better response rates and survival than historical controls treated with other second-line regimens. The toxicity profile of atezolizumab is also favorable. Trials are currently assessing whether atezolizumab is effective in earlier bladder cancer stages and in the first-line metastatic setting. Clin Cancer Res; 23(8); 1886-90. ©2016 AACR . ©2016 American Association for Cancer Research.

Efficacy of doxorubicin-based chemotherapy for non-resectable canine subcutaneous haemangiosarcoma.

PubMed

Wiley, J L; Rook, K A; Clifford, C A; Gregor, T P; Sorenmo, K U

2010-09-01

Eighteen dogs with measurable subcutaneous haemangiosarcoma (SQHSA) were treated with doxorubicin-based chemotherapy. Response assessment was evaluated and compared using World Health Organization (WHO), Response Evaluation Criteria in Solid Tumours (RECIST) and tumour volume criteria. The overall response rate for all dogs was 38.8% using WHO criteria, 38.8% using RECIST criteria and 44% using tumour volume criteria. One dog had a complete response. The median response duration for all dogs was 53 days (range 13-190 days). Four dogs had complete surgical excision after neoadjuvant chemotherapy. The median progression-free interval for dogs with complete surgical excision after neoadjuvant chemotherapy was significantly longer than those not having surgical excision (207 days versus 83 days, respectively) (P = 0.003). No significant difference in metastasis-free interval or survival time was found between the groups. Doxorubicin-based chemotherapy appears to be effective for non-resectable canine SQHSA, although the response duration is relatively short.

Missing metastases as a model to challenge current therapeutic algorithms in colorectal liver metastases.

PubMed

Lucidi, Valerio; Hendlisz, Alain; Van Laethem, Jean-Luc; Donckier, Vincent

2016-04-21

In oncosurgical approach to colorectal liver metastases, surgery remains considered as the only potentially curative option, while chemotherapy alone represents a strictly palliative treatment. However, missing metastases, defined as metastases disappearing after chemotherapy, represent a unique model to evaluate the curative potential of chemotherapy and to challenge current therapeutic algorithms. We reviewed recent series on missing colorectal liver metastases to evaluate incidence of this phenomenon, predictive factors and rates of cure defined by complete pathologic response in resected missing metastases and sustained clinical response when they were left unresected. According to the progresses in the efficacy of chemotherapeutic regimen, the incidence of missing liver metastases regularly increases these last years. Main predictive factors are small tumor size, low marker level, duration of chemotherapy, and use of intra-arterial chemotherapy. Initial series showed low rates of complete pathologic response in resected missing metastases and high recurrence rates when unresected. However, recent reports describe complete pathologic responses and sustained clinical responses reaching 50%, suggesting that chemotherapy could be curative in some cases. Accordingly, in case of missing colorectal liver metastases, the classical recommendation to resect initial tumor sites might have become partially obsolete. Furthermore, the curative effect of chemotherapy in selected cases could lead to a change of paradigm in patients with unresectable liver-only metastases, using intensive first-line chemotherapy to intentionally induce missing metastases, followed by adjuvant surgery on remnant chemoresistant tumors and close surveillance of initial sites that have been left unresected.

Nomograms Predicting Response to Therapy and Outcomes After Bladder-Preserving Trimodality Therapy for Muscle-Invasive Bladder Cancer

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

Coen, John J., E-mail: jcoen@harthosp.org; Paly, Jonathan J.; Niemierko, Andrzej

2013-06-01

Purpose: Selective bladder preservation by use of trimodality therapy is an established management strategy for muscle-invasive bladder cancer. Individual disease features have been associated with response to therapy, likelihood of bladder preservation, and disease-free survival. We developed prognostic nomograms to predict the complete response rate, disease-specific survival, and likelihood of remaining free of recurrent bladder cancer or cystectomy. Methods and Materials: From 1986 to 2009, 325 patients were managed with selective bladder preservation at Massachusetts General Hospital (MGH) and had complete data adequate for nomogram development. Treatment consisted of a transurethral resection of bladder tumor followed by split-course chemoradiation. Patientsmore » with a complete response at midtreatment cystoscopic assessment completed radiation, whereas those with a lesser response underwent a prompt cystectomy. Prognostic nomograms were constructed predicting complete response (CR), disease-specific survival (DSS), and bladder-intact disease-free survival (BI-DFS). BI-DFS was defined as the absence of local invasive or regional recurrence, distant metastasis, bladder cancer-related death, or radical cystectomy. Results: The final nomograms included information on clinical T stage, presence of hydronephrosis, whether a visibly complete transurethral resection of bladder tumor was performed, age, sex, and tumor grade. The predictive accuracy of these nomograms was assessed. For complete response, the area under the receiving operating characteristic curve was 0.69. The Harrell concordance index was 0.61 for both DSS and BI-DFS. Conclusions: Our nomograms allow individualized estimates of complete response, DSS, and BI-DFS. They may assist patients and clinicians making important treatment decisions.« less

Use of rituximab as a treatment for systemic lupus erythematosus: retrospective review

PubMed Central

Machado, Roberta Ismael Lacerda; Scheinberg, Morton Aaron; de Queiroz, Maria Yvone Carlos Formiga; de Brito, Danielle Christinne Soares Egypto; Guimarães, Maria Fernanda Brandao de Resende; Giovelli, Raquel Altoé; Freire, Eutilia Andrade Medeiros

2014-01-01

ABSTRACT Objective: To report the experience in three Brazilian institutions with the use of rituximab in patients with different clinical forms of lupus erythematosus systemic in activity. Methods: The study consisted of a sample of 17 patients with LES, who were already being treated, but that at some stage of the disease showed refractory symptoms. The patients were subdivided into groups according to the clinical manifestation, and the responses for the use of rituximab were rated as complete, partial or no response. Data were collected through a spreadsheet, and used specific parameters for each group. The treatment was carried on by using therapeutic dose of 1g, and repeating the infusion within an interval of 15 days. Results: The clinical responses to rituximab of the group only hematological and of the group only osteoarticular were complete in all cases. In the renal group there was a clinical complete response, two partial and one absent. In the renal and hematological group complete response, there was one death and a missing response. The pulmonary group presented a complete response and two partial. Conclusion: The present study demonstrated that rituximab can bring benefits to patients with lupus erythematosus systemic, with good tolerability and mild side effects; it presented, however, variable response according to the system affected. PMID:24728244

Reduced Nicotine Content Expectancies Affect Initial Responses to Smoking.

PubMed

Mercincavage, Melissa; Smyth, Joshua M; Strasser, Andrew A; Branstetter, Steven A

2016-10-01

We sought to determine if negative responses to reduced nicotine content (RNC) cigarettes during open-label trials result from smokers' (negative) expectancies. We examined the effects of nicotine content description - independent of actual nicotine content - on subjective responses (craving reduction, withdrawal suppression, mood changes, and sensory ratings) and smoking behaviors (topography measures and carbon monoxide [CO] boost). Thirty-six 12-hour-abstinent daily smokers completed a 3-session crossover trial. During each session, participants smoked their preferred brand cigarette - blinded and described as containing "usual," "low," and "very low" nicotine content - through a topography device and completed CO and subjective response assessments. Although nicotine content was identical, compared to the "usual" content cigarette, participants experienced less craving reduction after smoking the "very low" nicotine cigarette, and rated its smoke as weaker (p < .05). Participants took shallower puffs of the "low" nicotine cigarette (p < .05), and rated the "low" and "very low" nicotine cigarettes as weaker and too mild (p < .01). Negative responses to RNC cigarettes may be due, in part, to negative expectancies about using cigarettes containing less nicotine. In this context, RNC cigarette marketing and labeling are likely important considerations if a federal nicotine reduction policy is initiated.

Can granisetron injection used as primary prophylaxis improve the control of nausea and vomiting with low- emetogenic chemotherapy?

PubMed

Keat, Chan Huan; Phua, Gillian; Abdul Kassim, Mohd Shainol; Poh, Wong Kar; Sriraman, Malathi

2013-01-01

The purpose of this study is to examine the risk of uncontrolled chemotherapy-induced nausea and vomiting (CINV) among patients receiving low emetogenic chemotherapy (LEC) with and without granisetron injection as the primary prophylaxis in addition to dexamethasone and metochlopramide. This was a single-centre, prospective cohort study. A total of 96 patients receiving LEC (52 with and 42 without granisetron) were randomly selected from the full patient list generated using the e-Hospital Information System (e-His). The rates of complete control (no CINV from days 1 to 5) and complete response (no nausea or vomiting in both acute and delayed phases) were identified through patient diaries which were adapted from the MASCC Antiemesis Tool (MAT). Selected covariates including gender, age, active alcohol consumption, morning sickness and previous chemotherapy history were controlled using the multiple logistic regression analyses. Both groups showed significant difference with LEC regimens (p<0.001). No differences were found in age, gender, ethnic group and other baseline characteristics. The granisetron group indicated a higher complete response rate in acute emesis (adjusted OR: 0.1; 95%CI 0.02-0.85; p=0.034) than did the non-granisetron group. Both groups showed similar complete control and complete response rates for acute nausea, delayed nausea and delayed emesis. Granisetron injection used as the primary prophylaxis in LEC demonstrated limited roles in CINV control. Optimization of the guideline-recommended antiemetic regimens may serve as a less costly alternative to protect patients from uncontrolled acute emesis.

Primary Therapy of Waldenström Macroglobulinemia With Bortezomib, Dexamethasone, and Rituximab: WMCTG Clinical Trial 05-180

PubMed Central

Treon, Steven P.; Ioakimidis, Leukothea; Soumerai, Jacob D.; Patterson, Christopher J.; Sheehy, Patricia; Nelson, Marybeth; Willen, Michael; Matous, Jeffrey; Mattern, John; Diener, Jakow G.; Keogh, George P.; Myers, Thomas J.; Boral, Andy; Birner, Ann; Esseltine, Dixie L.; Ghobrial, Irene M.

2009-01-01

Purpose We examined the activity of bortezomib, dexamethasone, and rituximab (BDR) in patients with symptomatic, untreated Waldenström macroglobulinemia (WM). Patients and Methods A cycle of therapy consisted of bortezomib 1.3 mg/m2 intravenously; dexamethasone 40 mg on days 1, 4, 8, and 11; and rituximab 375 mg/m2 on day 11. Patients received four consecutive cycles for induction therapy and then four more cycles, each given 3 months apart, for maintenance therapy. Twenty-three patients received a median of seven cycles of treatment. Results Median bone marrow disease involvement declined from 55% to 10% (P = .0004), serum immunoglobulin M levels declined from 4,830 to 1,115 mg/dL (P < .0001), and hematocrit increased from 29.8% to 38.2% (P = .0002) at best response. The overall response rates and major response rates were 96% and 83% with three complete responses, two near complete responses, three very good partial responses, 11 partial responses, and three minor responses. Responses occurred at a median of 1.4 months. With a median follow-up of 22.8 months, 18 of 23 patients remained free of disease progression. Peripheral neuropathy was the most common toxicity, and it resolved to grade ≤ 1 in 13 of 16 patients at a median of 6.0 months. Four of the first seven treated patients developed herpes zoster, resulting in the institution of prophylactic antiviral therapy. Conclusion The results demonstrate that BDR produces rapid and durable responses, along with high rates of response and complete remissions in WM. Herpes zoster prophylaxis is necessary with BDR, and reversible peripheral neuropathy was the most common toxicity leading to premature discontinuation of bortezomib in 61% of patients. Exploration of alternative schedules for bortezomib administration that includes weekly dosing should be pursued. PMID:19506160

Web-Based Recruitment and Survey Methodology to Maximize Response Rates from Followers of Popular Diets: the Adhering to Dietary Approaches for Personal Taste (ADAPT) Feasibility Survey

PubMed Central

Karlsen, Micaela C; Lichtenstein, Alice H; Economos, Christina D; Folta, Sara C; Rogers, Gail; Jacques, Paul F; Livingston, Kara A; Rancaño, Katherine M; McKeown, Nicola M

2018-01-01

Abstract Background Although there is interest in popular diets such as vegan and vegetarian, Paleo, and other “whole food” diets, existing cohort studies lack data for these subgroups. The use of electronic data capture and Web-based surveys in nutrition research may be valuable for future studies by allowing targeting of specific dietary subgroups. Objective The aim was to perform a Feasibility Survey (FS) to assess the practicality of Web-based research methods to gather data and to maximize response rates among followers of popular diets. Methods The FS was an open, voluntary, 15-min survey conducted over 8 wk in the summer of 2015. Recruitment targeted self-identified followers of popular diets from a convenience sample, offering no incentives, via social media and e-newsletters shared by recruitment partners. Feasibility was assessed by number of responses, survey completion rate, distribution of diets, geographic location, and willingness to participate in future research. Results A total of 14,003 surveys were initiated; 13,787 individuals consented, and 9726 completed the survey (71% of consented). The numbers of unique visitors to the questionnaire site, view rate, and participation rate were not captured. Among respondents with complete demographic data, 83% were female and 93% were white. Diet designations were collapsed into the following groups: whole-food, plant-based (25%); vegan and raw vegan (19%); Paleo (14%); try to eat healthy (11%); vegetarian and pescatarian (9%); whole food (8%); Weston A Price (5%); and low-carbohydrate (low-carb) (4%). Forced-response, multiple-choice questions produced the highest response rates (0–2% selected “prefer not to answer”). The percentage who were willing to complete future online questionnaires was 86%, diet recall was 93%, and food diary was 75%; the percentages willing to provide a finger-stick blood sample, venipuncture blood sample, urine sample, and stool sample were 60%, 44%, 58%, and 42%, respectively. Conclusions This survey suggests that recruiting followers of popular diets is feasible with the use of Web-based methods. The unbalanced sample with respect to sex and race/ethnicity could be corrected with specific recruitment strategies using targeted online marketing techniques. PMID:29955724

The short-term outcomes of induction SOX (S-1 + oxaliplatin) ± cetuximab chemotherapy followed by short-course chemoradiotherapy in patients with poor-risk locally advanced rectal cancer.

PubMed

Beppu, Naohito; Yoshie, Hidenori; Kimura, Fumihiko; Aihara, Tsukasa; Doi, Hiroshi; Kamikonya, Norihiko; Matsubara, Nagahide; Tomita, Naohiro; Yanagi, Hidenori; Yamanaka, Naoki

2016-10-01

To evaluate the safety and efficacy of induction SOX (S-1 + oxaliplatin) ± cetuximab chemotherapy followed by short-course chemoradiotherapy and surgery in patients with poor-risk locally advanced rectal cancer. We enrolled eligible patients with poor-risk rectal cancer defined as T3 lower rectal cancer with mesorectal fascia involvement, T4a or T4b tumors or cases with lateral lymph node swelling. The primary endpoint was a pathological complete response (pCR), and the secondary endpoints were the objective response rate (ORR) and the pathological high response rate (Grade 2 plus 3). Twenty eligible patients were enrolled. The majority (75.0 %, 15/20) of the patients completed four cycles of induction chemotherapy, and all patients completed the radiotherapy (25 Gy/10 fractions/5 days). The global rate of Grade 3-4 toxicities was 30.0 % (6/20 patients). The ORRs were 85.0 % (17/20) and 95.0 % (19/20) in the patients who underwent R0 and R1 resection, respectively. The pathological high response rate was 70.0 % (14/20) and the pCR was 10.0 % (2/20). The regimen of induction SOX (S-1 + oxaliplatin) ± cetuximab chemotherapy followed by short-course chemoradiotherapy is safe and is associated with good tumor regression in patients with poor-risk locally advanced rectal cancer.

Improving response rate and quality of survey data with a scratch lottery ticket incentive

PubMed Central

2012-01-01

Background The quality of data collected in survey research is usually indicated by the response rate; the representativeness of the sample, and; the rate of completed questions (item-response). In attempting to improve a generally declining response rate in surveys considerable efforts are being made through follow-up mailings and various types of incentives. This study examines effects of including a scratch lottery ticket in the invitation letter to a survey. Method Questionnaires concerning oral health were mailed to a random sample of 2,400 adults. A systematically selected half of the sample (1,200 adults) received a questionnaire including a scratch lottery ticket. One reminder without the incentive was sent. Results The incentive increased the response rate and improved representativeness by reaching more respondents with lower education. Furthermore, it reduced item nonresponse. The initial incentive had no effect on the propensity to respond after the reminder. Conclusion When attempting to improve survey data, three issues become important: response rate, representativeness, and item-response. This study shows that including a scratch lottery ticket in the invitation letter performs well on all the three. PMID:22515335

Practice Research: General practitioners' awareness of colorectal cancer

PubMed Central

Nichols, Sally

1986-01-01

A survey was carried out in Portsmouth to find out what general practitioners knew about colorectal cancer and what their views were on screening. A random sample of general practitioners was interviewed by questionnaire and the remainder asked to complete the questionnaire themselves. The overall response rate was 62%. There was a higher response rate from women doctors and from the group that was interviewed. For some questions there was a difference in the pattern of responses given by the interview group and the group who completed the questionnaire themselves. The level of knowledge of colorectal cancer varied according to which aspect was questioned. The general practitioners knew the symptoms well but were less aware of the vital statistics and risk factors. Most doctors were not in favour of screening by testing for faecal occult blood. PMID:3080150

Phase II Trial of Induction Chemotherapy Followed by Surgery for Squamous Cell Carcinoma of the Oral Tongue in Young Adults

PubMed Central

Kies, Merrill S.; Boatright, Dowin H.; Li, Guojun; Blumenschein, George; El-Naggar, Adel K.; Lewin, Jan S.; Steinhaus, Ganene; Sturgis, Erich M.

2013-01-01

Background We conducted a phase II clinical trial of induction chemotherapy followed by surgery ± radiotherapy for squamous cell carcinoma of the oral tongue (SCCOT) in young adults. Methods From September 2001 to October 2004, 23 patients aged 18–49 years with clinical T2-3N0-2M0 SCCOT and no prior radiotherapy, chemotherapy, or neck dissection underwent induction chemotherapy (paclitaxel, ifosfamide, and carboplatin) followed by glossectomy and neck dissection ± radiotherapy and chemotherapy. Results On final surgical pathology, 9 (39%) patients had a complete/major (2 complete) histologic response at the primary tumor site; 8 (35%) had no response or progression. Similarly, 9 (39%) patients had a complete response in the neck or remained node negative; 6 (26%) had an increase in nodal category. No treatment-associated deaths occurred, and toxicity was modest. At a median follow-up from the end of treatment of 52 months (minimum, 23 months), 10 (43%) patients developed recurrence, and all 10 died of cancer. Crude recurrence/cancer death rates were associated with ≤ a partial response at the tongue (P = .029), poor histologic differentiation (P = .012), and multiple adverse features on final surgical pathology (P = .040). Conclusions Response rates and overall survival with this induction chemotherapy regimen were limited, but complete/major response at the tongue was associated with excellent prognosis. Additionally, improved patient selection and predictive tumor biomarkers will be needed for induction chemotherapy to be routinely incorporated into the treatment of oral tongue cancer in young adults. PMID:22009800

Phase II trial of induction chemotherapy followed by surgery for squamous cell carcinoma of the oral tongue in young adults.

PubMed

Kies, Merrill S; Boatright, Dowin H; Li, Guojun; Blumenschein, George; El-Naggar, Adel K; Brandon Gunn, G; Lewin, Jan S; Steinhaus, Ganene D; Sturgis, Erich M

2012-09-01

We conducted a phase II clinical trial of induction chemotherapy followed by surgery ± radiotherapy for squamous cell carcinoma of the oral tongue (SCCOT) in young adults. From September 2001 to October 2004, 23 patients aged 18 to 49 years with clinical T2-3 N0-2 M0 SCCOT and no prior radiotherapy, chemotherapy, or neck dissection underwent induction chemotherapy (paclitaxel, ifosfamide, and carboplatin) followed by glossectomy and neck dissection ± radiotherapy and chemotherapy. On final surgical pathology, 9 patients (39%) had a complete/major (2 complete) histologic response at the primary tumor site; 8 patients (35%) had no response or progression. Similarly, 9 patients (39%) had a complete response in the neck or remained node negative; 6 patients (26%) had an increase in nodal category. No treatment-associated deaths occurred, and toxicity was modest. At a median follow-up from the end of treatment of 52 months (minimum, 23 months), 10 patients (43%) developed recurrence, and all 10 died of cancer. Crude recurrence/cancer death rates were associated with ≤ a partial response at the tongue (p = .029), poor histologic differentiation (p = .012), and multiple adverse features on final surgical pathology (p = .040). Response rates and overall survival with this induction chemotherapy regimen were limited, but complete/major response at the tongue was associated with excellent prognosis. Additionally, improved patient selection and predictive tumor biomarkers will be needed for induction chemotherapy to be routinely incorporated into the treatment of oral tongue cancer in young adults. Copyright © 2011 Wiley Periodicals, Inc.

Combined local and systemic bleomycin administration in electrochemotherapy to reduce the number of treatment sessions

PubMed Central

Tellado, Matias; Olaiz, Nahuel; Michinski, Sebastian; Marshall, Guillermo

2016-01-01

Background Electrochemotherapy (ECT), a medical treatment widely used in human patients for tumor treatment, increases bleomycin toxicity by 1000 fold in the treated area with an objective response rate of around 80%. Despite its high response rate, there are still 20% of cases in which the patients are not responding. This could be ascribed to the fact that bleomycin, when administered systemically, is not reaching the whole tumor mass properly because of the characteristics of tumor vascularization, in which case local administration could cover areas that are unreachable by systemic administration. Patients and methods We propose combined bleomycin administration, both systemic and local, using companion animals as models. We selected 22 canine patients which failed to achieve a complete response after an ECT treatment session. Eleven underwent another standard ECT session (control group), while 11 received a combined local and systemic administration of bleomycin in the second treatment session. Results According to the WHO criteria, the response rates in the combined administration group were: complete response (CR) 54% (6), partial response (PR) 36% (4), stable disease (SD) 10% (1). In the control group, these were: CR 0% (0), PR 19% (2), SD 63% (7), progressive disease (PD) 18% (2). In the combined group 91% objective responses (CR+PR) were obtained. In the control group 19% objective responses were obtained. The difference in the response rate between the treatment groups was significant (p < 0.01). Conclusions Combined local and systemic bleomycin administration was effective in previously to ECT non responding canine patients. The results indicate that this approach could be useful and effective in specific population of patients and reduce the number of treatment sessions needed to obtain an objective response. PMID:27069450

Hydraulic Fracturing Completion Volume is Associated with Induced Earthquake Productivity in the Duvernay Play

NASA Astrophysics Data System (ADS)

Schultz, R.; Atkinson, G. M.; Eaton, D. W. S.; Gu, Y. J.; Kao, H.

2017-12-01

A sharp increase in the frequency of earthquakes near Fox Creek, Alberta began in December 2013 as a result of hydraulic fracturing completions in the Duvernay Formation. Using a newly compiled hydraulic fracturing database, we explore relationships between injection parameters and seismicity response. We find that induced earthquakes are associated with pad completions that used larger injection volumes (104-5 m3) and that seismic productivity scales linearly with injection volume. Injection pressure and rate have limited or insignificant correlation with the seismic response. Further findings suggest that geological susceptibilities play a prominent role in seismic productivity, as evidenced by spatial correlations in the seismicity patterns. Together, volume and geological susceptibilities account for 96% of the variability in the induced earthquake rate near Fox Creek. We suggest this result is fit by a modified Gutenberg-Richter earthquake frequency-magnitude distribution which provides a conceptual framework with which to forecast induced seismicity hazard.

Numbering questionnaires had no impact on the response rate and only a slight influence on the response content of a patient safety culture survey: a randomized trial.

PubMed

Kundig, François; Staines, Anthony; Kinge, Thompson; Perneger, Thomas V

2011-11-01

In self-completed surveys, anonymous questionnaires are sometimes numbered so as to avoid sending reminders to initial nonrespondents. This number may be perceived as a threat to confidentiality by some respondents, which may reduce the response rate, or cause social desirability bias. In this study, we evaluated whether using nonnumbered vs. numbered questionnaires influenced the response rate and the response content. During a patient safety culture survey, we randomized participants into two groups: one received an anonymous nonnumbered questionnaire and the other a numbered questionnaire. We compared the survey response rates and distributions of the responses for the 42-questionnaire items across the two groups. Response rates were similar in the two groups (nonnumbered, 75.2%; numbered, 72.8%; difference, 2.4%; P=0.28). Five of the 42 questions had statistically significant differences in distributions, but these differences were small. Unexpectedly, in all five instances, the patient safety culture ratings were more favorable in the nonnumbered group. Numbering of mailed questionnaires had no impact on the response rate. Numbering influenced significantly the response content of several items, but these differences were small and ran against the hypothesis of social desirability bias. Copyright © 2011 Elsevier Inc. All rights reserved.

Radiochemotherapy in Anal Cancer: cCR, clinical outcomes and quality of life using two different treatment schedules

PubMed Central

Di Santo, Sara; Trignani, Marianna; Neri, Matteo; Milano, Angelo; Innocenti, Paolo; Taraborrelli, Maria; Augurio, Antonietta; Vinciguerra, Annamaria; Di Tommaso, Monica; Ursini, Lucia Anna; Di Pilla, Angelo; Di Nicola, Marta; Genovesi, Domenico

2014-01-01

Aim Main endpoint was a response rate to therapy; secondary endpoints were disease-free survival, overall survival, acute and late toxicities, specially in terms of anorectal and urinary continence. Background Radiochemotherapy for anal cancer achieves a good clinical response, locoregional control, anal function preservation. However, oncologic outcomes can differ using radiotherapy plus fluorouracil and mytomicin vs. cisplatin and fluorouracil. Methods Between 2000 and 2012, 27 anal cancer patients receiving radiotherapy combined with two different radiochemotherapy schedules, fluorouracil and mytomicin (group A) and cisplatin plus fluorouracil (group B). The Kaplan–Meier method was also used to estimate local control, overall survival and disease free survival. Statistical significance between curves was evaluated using the Log-rank test. Results Complete pathological response was found in 85.2% of patients, with higher rates of response in the group A (100% vs. 63.6%, p = 0.039). No significantly difference was found between the two groups for the other endpoints. Low rates of both acute and late toxicities were recorded. Conclusion Radiotherapy plus fluorouracil and mytomicin provide a better complete pathological response than radiotherapy plus cisplatin and fluorouracil and a greater rate of anal sphincter function preservation. Globally, radiochemotherapy of the anal cancer provides excellent clinical outcomes with a good profile of acute and late toxicity, without difference between the two groups studied. PMID:25859401

Clinical comparison and complete cure rates of Terbinafine efficacy in affected onychomycotic toenails.

PubMed

Shemer, A; Sakka, N; Baran, R; Scher, R; Amichai, B; Norman, L; Farhi, R; Magun, R; Brazilai, A; Daniel, R

2015-03-01

Clinical studies regarding complete cure rate of onychomycosis using oral Terbinafine have a very broad range (14-90%) based solely on response to treatment on the big toenail. To evaluate the efficacy of Terbinafine in all affected onychomycotic toenails and, furthermore, to evaluate differences in mycological, clinical and complete cure rate between affected onychomycotic toenails. Inclusion criteria are as follows: distolateralsubungual onychomycotic involvement of the hallux and additional involvement of at least two more toenails of the same foot. Exclusion criteria are as follows: patients with nail traumata and hypersensitivity to Terbinafine. Patients were treated with oral Terbinafine 250 mg/day for 16 weeks. Mycological analysis was performed using direct microscopy and culture. Clinical improvement was assessed using digital photography. Statistically significant difference was found in clinical improvement between the great toenail and all other involved toenails. The rate of complete cure (100% clinical cure and mycological cure) of the big toenail was lower (23%) as compared to the second (65%), third (51%) and the fourth toenail (67%). This is a case series study that was based on a single-centre cohort. Our results support findings that efficacy of Terbinafine should be based on all involved onychomycotic toenails; the big toenail is not superior in response compared to other affected toenails. © 2014 European Academy of Dermatology and Venereology.

Efficacy of skin-directed therapy for cutaneous metastases from advanced cancer: a meta-analysis.

PubMed

Spratt, Daniel E; Gordon Spratt, Elizabeth A; Wu, Shenhong; DeRosa, Antonio; Lee, Nancy Y; Lacouture, Mario E; Barker, Christopher A

2014-10-01

To perform the first meta-analysis of the efficacy of skin-directed therapies for cutaneous metastases. MEDLINE, EMBASE, The Cochrane Library, and ClinicalTrials.gov databases were searched for reports of prospective clinical studies published between 1960 and 2013 that assessed the response of skin-directed therapy for cutaneous metastases (47 of 2,955 unique studies were selected). Primary end points of the study were complete and objective response rates. Secondary analyses were preplanned and included subgroup analyses by skin-directed therapy, histology, and recurrence rates. Meta-analyses were performed with random-effect modeling, and extent of heterogeneity between studies was determined with the Cochran Q and I(2) tests. After applying exclusion criteria, 47 prospective studies of 4,313 cutaneous metastases were assessed. Five skin-directed therapies were identified: electrochemotherapy, photodynamic therapy, radiotherapy, intralesional therapy, and topical therapy. Among all cutaneous metastases, complete response rate was 35.5% (95% CI, 27.6% to 44.3%) and objective response rate was 60.2% (95% CI, 50.6% to 69.0%). Overall recurrence rate was estimated to be 9.2% (95% CI, 3.7% to 21.2%). Melanoma and breast carcinoma comprised 96.8% of all cutaneous metastases studied and had similar objective response rates (54.5% [95% CI, 48.3% to 60.7%] and 54.0% [95% CI, 48.3% to 59.7%], respectively). Grade ≥ 3 toxicity was reported in less than 6% of patients. Response to skin-directed therapy for cutaneous metastases is high but heterogeneous across treatment modalities, with low rates of recurrence post-treatment. Treatment was generally well tolerated and conferred improvements in quality of life. Standardization of response criteria for cutaneous metastases and treatment algorithms to optimally use the available skin-directed therapies are needed. © 2014 by American Society of Clinical Oncology.

5 CFR 530.307 - OPM review and adjustment of special rate schedules.

Code of Federal Regulations, 2011 CFR

2011-01-01

... a review of one or more special rate schedules. (b) OPM may designate lead agencies to assist in the... affected agency is responsible for submitting complete supporting data upon request to OPM or the lead... recruitment or retention of qualified employees, OPM may discontinue the schedule or rate range. Consistent...

Choice with a fixed requirement for food, and the generality of the matching relation

PubMed Central

Stubbs, D. Alan; Dreyfus, Leon R.; Fetterman, J. Gregor; Dorman, Lana G.

1986-01-01

Pigeons were trained on choice procedures in which responses on each of two keys were reinforced probabilistically, but only after a schedule requirement had been met. Under one arrangement, a fixed-interval choice procedure was used in which responses were not reinforced until the interval was over; then a response on one key would be reinforced, with the effective key changing irregularly from interval to interval. Under a second, fixed-ratio choice procedure, responses on either key counted towards completion of the ratio and then, once the ratio had been completed, a response on the probabilistically selected key would produce food. In one experiment, the schedule requirements were varied for both fixed-interval and fixed-ratio schedules. In the second experiment, relative reinforcement rate was varied. And in a third experiment, the duration of an intertrial interval separating choices was varied. The results for 11 pigeons across all three experiments indicate that there were often large deviations between relative response rates and relative reinforcement rates. Overall performance measures were characterized by a great deal of variability across conditions. More detailed measures of choice across the schedule requirement were also quite variable across conditions. In spite of this variability, performance was consistent across conditions in its efficiency of producing food. The absence of matching of behavior allocation to reinforcement rate indicates an important difference between the present procedures and other choice procedures; that difference raises questions about the specific conditions that lead to matching as an outcome. PMID:16812452

Role of endoscopic biliary drainage in advanced hepatocellular carcinoma with jaundice

PubMed Central

Han, Sung Yong; Heo, Jeong; Kim, Dong Uk; Baek, Dong Hoon; Yoo, So Yong; Kim, Chang Won; Kim, Suk; Song, Geun Am; Cho, Mong; Kang, Dae Hwan

2017-01-01

Background Patients with advanced hepatocellular carcinoma (HCC) with jaundice have an extremely poor prognosis. Although biliary drainage can resolve obstructive jaundice, signs of obstruction may not be evident. This study evaluated the role of endoscopic biliary drainage in patients with advanced HCC and obstructive jaundice. Methods From 2010 to 2015, 74 patients underwent endoscopic biliary drainage for obstructive jaundice due to advanced HCC. Jaundice resolution was defined as complete response and total bilirubin concentration below 3 mg/dl. Results The technical success rate in the 74 patients was 92.1% (70/76). Of the 70 patients who underwent successful biliary drainage, 48 (68.6%) and 22 (31.4%) were Child-Pugh classes B and C, respectively, and 10 (14.3%) and 60 (85.7%) were BCLC stages B and C, respectively. Intrahepatic bile duct (IHD) dilatation was observed in 35 patients (50%). After drainage, the complete response rate was 35.7% (25/70). The mean time to resolution was 17.4 ±8.5 days. However, jaundice was re-aggravated in 74.3% (15/25) after a mean 103.5 ±96.4 days. Multivariate analysis showed that the absence of ascites, presence of IHD dilatation, normal range of prothrombin time, and lower MELD score were significantly associated with complete response. The overall survival rate was 15.7% (11/70) and the median survival time is 28 days (95% confidence interval 2.6–563 days). Complete response and HCC treatment after drainage were significantly associated with survival. Conclusion Effective endoscopic biliary drainage is an important palliative treatment in patients with advanced HCC and obstructive jaundice, especially those with IHD dilatation and preserved liver function, as determined by ascites, prothrombin time, and MELD score. PMID:29095941

Role of endoscopic biliary drainage in advanced hepatocellular carcinoma with jaundice.

PubMed

Woo, Hyun Young; Han, Sung Yong; Heo, Jeong; Kim, Dong Uk; Baek, Dong Hoon; Yoo, So Yong; Kim, Chang Won; Kim, Suk; Song, Geun Am; Cho, Mong; Kang, Dae Hwan

2017-01-01

Patients with advanced hepatocellular carcinoma (HCC) with jaundice have an extremely poor prognosis. Although biliary drainage can resolve obstructive jaundice, signs of obstruction may not be evident. This study evaluated the role of endoscopic biliary drainage in patients with advanced HCC and obstructive jaundice. From 2010 to 2015, 74 patients underwent endoscopic biliary drainage for obstructive jaundice due to advanced HCC. Jaundice resolution was defined as complete response and total bilirubin concentration below 3 mg/dl. The technical success rate in the 74 patients was 92.1% (70/76). Of the 70 patients who underwent successful biliary drainage, 48 (68.6%) and 22 (31.4%) were Child-Pugh classes B and C, respectively, and 10 (14.3%) and 60 (85.7%) were BCLC stages B and C, respectively. Intrahepatic bile duct (IHD) dilatation was observed in 35 patients (50%). After drainage, the complete response rate was 35.7% (25/70). The mean time to resolution was 17.4 ±8.5 days. However, jaundice was re-aggravated in 74.3% (15/25) after a mean 103.5 ±96.4 days. Multivariate analysis showed that the absence of ascites, presence of IHD dilatation, normal range of prothrombin time, and lower MELD score were significantly associated with complete response. The overall survival rate was 15.7% (11/70) and the median survival time is 28 days (95% confidence interval 2.6-563 days). Complete response and HCC treatment after drainage were significantly associated with survival. Effective endoscopic biliary drainage is an important palliative treatment in patients with advanced HCC and obstructive jaundice, especially those with IHD dilatation and preserved liver function, as determined by ascites, prothrombin time, and MELD score.

Targeting Mutant BRAF with Vemurafenib in Relapsed or Refractory Hairy Cell Leukemia

PubMed Central

Tiacci, Enrico; Park, Jae H.; De Carolis, Luca; Chung, Stephen S.; Broccoli, Alessandro; Scott, Sasinya; Zaja, Francesco; Devlin, Sean; Pulsoni, Alessandro; Chung, Young Rock; Cimminiello, Michele; Kim, Eunhee; Rossi, Davide; Stone, Richard M.; Motta, Giovanna; Saven, Alan; Varettoni, Marzia; Altman, Jessica K.; Anastasia, Antonella; Grever, Michael R.; Ambrosetti, Achille; Rai, Kanti R.; Fraticelli, Vincenzo; Lacouture, Mario E.; Carella, Angelo Michele; Levine, Ross L.; Leoni, Pietro; Rambaldi, Alessandro; Falzetti, Franca; Ascani, Stefano; Capponi, Monia; Martelli, Maria Paola; Park, Christopher Y.; Pileri, Stefano Aldo; Rosen, Neal; Foà, Robin; Berger, Michael F.; Zinzani, Pier Luigi; Abdel-Wahab, Omar; Falini, Brunangelo; Tallman, Martin S.

2016-01-01

BACKGROUND BRAF-V600E is the genetic lesion underlying hairy cell leukemia. We assessed the safety and activity of the oral BRAF inhibitor vemurafenib in patients with hairy cell leukemia who relapsed after or were refractory to purine analogues. METHODS We conducted in Italy and USA two phase-2 single-arm multicenter studies of vemurafenib (960 mg twice daily) given for a median of 16 and 18 weeks, respectively. Primary endpoints were complete remission rate and overall response rate. Patient enrollment was completed (n=28) in the Italian trial in April 2013 and is still open (n=26/36) in the American trial. RESULTS Drug-related adverse events were usually of grade 1-2, and those most frequently requiring dose reductions were rash and arthralgia/arthritis; secondary cutaneous tumors (treated with simple excision) developed in 6/50 patients. Overall response rates were 96% (25/26 evaluable Italian patients) and 100% (24/24 evaluable American patients), obtained after a median of 8 weeks and 12 weeks, respectively. Complete response rates were 34.6% (9/26) and 41.7% (10/24), respectively. In the Italian trial, after a median follow-up of 23 months, the median relapse-free and treatment-free survivals were respectively 19 and 25 months in complete responders, and 6 and 18 months in partial responders. In the American trial, 1-year progression-free and overall survival were 73% and 91%, respectively. Frequent persistence of phospho-ERK+ bone marrow leukemic cells at the end of treatment suggests bypass MEK-ERK reactivation as a resistance mechanism. CONCLUSIONS A short oral course of vemurafenib proved safe and highly effective in relapsed/refractory hairy cell leukemia patients (Funded by AIRC, ERC, Roche/Genentech and others; EudractCT number: 2011-005487-13, ClinicalTrials.gov number NCT01711632). PMID:26352686

Could less be more when assessing patient-rated outcome in spinal stenosis?

PubMed

Mannion, Anne F; Fekete, Tamas F; Wertli, Maria M; Mattle, Michele; Nauer, Selina; Kleinstück, Frank S; Jeszenszky, Dezsö; Haschtmann, Daniel; Becker, Hans-Jürgen; Porchet, François

2015-05-15

Longitudinal study of the measurement properties of a brief outcome instrument. In patients undergoing surgery for lumbar spinal stenosis, we compared the responsiveness of the Core Outcome Measures Index (COMI) with that of the condition-specific Swiss Spinal Stenosis Measure (SSM), an instrument developed to assess patients with neurogenic claudication. The COMI is a validated multidimensional questionnaire for assessing the key outcomes of importance to patients with back problems. Being brief, it is associated with minimal respondent burden and high completion rates. However, for a given pathology, intuitively it may be expected to be less responsive than a condition-specific instrument. A total of 91 patients (73±8 yr; 53% males) completed the following questionnaires before surgery: COMI, SSM, Roland Morris Disability Questionnaire, back trouble "Feeling Thermometer," pain numeric rating scale, EuroQoL-visual analogue scale. Twelve months postoperatively, 78/91 (86%) completed all the questionnaires again; they also rated the "global treatment outcome" (GTO; rated 1-5) and SSM "satisfaction with treatment result" (SSM-sat; rated 1-4), which were used as external criteria of treatment success. Scores for the external criteria of success (GTO/SSM-sat) correlated with the change scores (baseline to 12 mo) in COMI (r=0.57) and SSM (r=0.54) to a similar extent. Using receiver operating characteristics, with GTO or SSM-sat dichotomized as external criterion, the area under the curve was similar for the COMI change score (0.86-0.90) and the SSM (sub)scales (0.80-0.90). With either SSM-sat or GTO serving as the external criterion, COMI was as responsive as the SSM. The COMI is well able to detect important change in lumbar spinal stenosis and has the added benefit of reducing the response burden for the patient and facilitating outcome comparisons with other spinal pathologies. 2.

Dose-Effect Relationship in Chemoradiotherapy for Locally Advanced Rectal Cancer: A Randomized Trial Comparing Two Radiation Doses

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

Jakobsen, Anders, E-mail: anders.jakobsen@slb.regionsyddanmark.dk; University of Southern Denmark, Odense; Ploen, John

2012-11-15

Purpose: Locally advanced rectal cancer represents a major therapeutic challenge. Preoperative chemoradiation therapy is considered standard, but little is known about the dose-effect relationship. The present study represents a dose-escalation phase III trial comparing 2 doses of radiation. Methods and Materials: The inclusion criteria were resectable T3 and T4 tumors with a circumferential margin of {<=}5 mm on magnetic resonance imaging. The patients were randomized to receive 50.4 Gy in 28 fractions to the tumor and pelvic lymph nodes (arm A) or the same treatment supplemented with an endorectal boost given as high-dose-rate brachytherapy (10 Gy in 2 fractions; armmore » B). Concomitant chemotherapy, uftoral 300 mg/m{sup 2} and L-leucovorin 22.5 mg/d, was added to both arms on treatment days. The primary endpoint was complete pathologic remission. The secondary endpoints included tumor response and rate of complete resection (R0). Results: The study included 248 patients. No significant difference was found in toxicity or surgical complications between the 2 groups. Based on intention to treat, no significant difference was found in the complete pathologic remission rate between the 2 arms (18% and 18%). The rate of R0 resection was different in T3 tumors (90% and 99%; P=.03). The same applied to the rate of major response (tumor regression grade, 1+2), 29% and 44%, respectively (P=.04). Conclusions: This first randomized trial comparing 2 radiation doses indicated that the higher dose increased the rate of major response by 50% in T3 tumors. The endorectal boost is feasible, with no significant increase in toxicity or surgical complications.« less

Prognostic value of neoadjuvant treatment response in locally advanced rectal cancer.

PubMed

Sada, Yvonne H; Tran Cao, Hop S; Chang, George J; Artinyan, Avo; Musher, Benjamin L; Smaglo, Brandon G; Massarweh, Nader N

2018-06-01

For locally advanced rectal cancer, response to neoadjuvant radiation has been associated with improved outcomes but has not been well characterized in general practice. The goals of this study were to describe disease response rates after neoadjuvant treatment and to evaluate the association between disease response and survival. Retrospective cohort study of patients aged 18-80 y with clinical stage II and III rectal adenocarcinoma in the National Cancer Database (2006-2012). All patients underwent radical resection after neoadjuvant treatment. Treatment responses were defined as follows: no tumor response; intermediate-T and/or N downstaging with residual disease; and complete-ypT0N0. Multivariable, multinomial regression was used to evaluate the association between neoadjuvant radiation use and disease response. Multivariable Cox regression was used to evaluate the association between disease response and overall risk of death. Among 12,024 patients, 12% had a complete and 30% an intermediate response. Neoadjuvant chemotherapy alone was less likely to achieve an intermediate (relative risk ratio: 0.70 [0.56-0.88]) or a complete response (relative risk ratio: 0.59 [0.41-0.84]) relative to neoadjuvant radiation. Tumor response was associated with improved 5-y overall survival (complete = 90.2%, intermediate = 82.0%, no response = 70.5%; log-rank, P < 0.001). Complete and intermediate pathologic responses were associated with decreases in risk of death (hazard ratio: 0.40 [0.34-0.48] and 0.63 [0.57-0.69], respectively) compared to no response. Primary tumor and nodal response were independently associated with decreased risk of death. Neoadjuvant radiation is associated with treatment response, and pathologic response is associated with improved survival. Pathologic response may be an early benchmark for the oncologic effectiveness of neoadjuvant treatment. Published by Elsevier Inc.

"Bird in the hand" cash was more effective than prize draws in increasing physician questionnaire response.

PubMed

Drummond, Frances J; O'Leary, Eamonn; O'Neill, Ciaran; Burns, Richeal; Sharp, Linda

2014-02-01

To investigate the effects of two monetary incentives on response rates to postal questionnaires from primary care physicians (PCPs). The PCPs were randomized into three arms (n=550 per arm), namely (1) €5 sent with the questionnaire (cash); (2) entry into a draw on return of completed questionnaire (prize); or (3) no incentive. Effects of incentives on response rates and item nonresponse were examined, as was cost-effectiveness. Response rates were significantly higher in the cash (66.1%; 95% confidence interval [CI]: 61.9, 70.4%) and prize arms (44.8%; 95% CI: 40.1, 49.3%) compared with the no-incentive arm (39.9%; 95% CI: 35.4, 44.3%). Adjusted relative risk of response was 1.17 (95% CI: 1.02, 1.35) and 1.68 (95% CI: 1.48, 1.91) in the prize and cash arms, respectively, compared with the no-incentive group. Costs per completed questionnaire were €9.85, €11.15, and €6.31 for the cash, prize, and no-incentive arms, respectively. Compared with the no-incentive arm, costs per additional questionnaire returned in the cash and prize arms were €14.72 and €37.20, respectively. Both a modest cash incentive and entry into a prize draw were effective in increasing response rates. The cash incentive was most effective and the most cost-effective. Where it is important to maximize response, a modest cash incentive may be cost-effective. Copyright © 2014 Elsevier Inc. All rights reserved.

The feasibility and cost of a large multicentre audit of process and outcome of prostatectomy.

PubMed Central

Emberton, M; Neal, D E; Black, N; Harrison, M; Fordham, M; McBrien, M P; Williams, R E; McPherson, K; Develin, H B

1995-01-01

Objective--To determine the feasibility of performing multicentre process and outcome audits of common interventions taking prostatic procedures as an example. Design--Prospective, cohort study. Setting--All National Health Service and independent hospitals in Northern, Wessex, Mersey, and South West Thames health regions. Patients--5361 men undergoing prostatectomy identified by 103 of the 107 urologists and general surgeons performing prostatectomy in the study regions. Main measures-- Rates of participation by surgeons and patients; completeness of clinical data provided by surgeons; patient response rate and completeness of patient derived data; and cost. Results--Most surgeons (103,96%) agreed to participate. Overall, the proportion of eligible patients invited to take part was high (89%), although this was only measured in South West Thames, where dedicated data collectors were employed. Few men (80, 1.5%) declined to participate. Of those surviving for three months after surgery, 82.4% (4226) completed and returned the postal questionnaire. The response rate was higher in South West Thames (86.7%) than in the other regions (80.6%-80.8%). The audit was well received: 91% of patients found the questionnaire easy to complete and only 2.3% of them disapproved. Completeness of data was high with both the hospital and patient questionnaires. Missing data occurred in less than 5% of responses to most questions. The attributable cost was 34.50 pounds per patient identified or 44 pounds for patients in whom either the treatment outcome or vital status was known three months after their prostatectomy. Conclusions--This multicentre audit of process and outcome of prostatectomy proved feasible in terms of surgeon participation, patient identification, and the quantity and quality of data collection. Whether the cost was warranted will depend on how surgeons use the audit data to modify their practice. PMID:10156395

Imatinib adherence associated clinical outcomes of chronic myeloid leukaemia treatment in Taiwan.

PubMed

Chen, Teng-Chou; Chen, Li-Chia; Huang, Yaw-Bin; Chang, Chao-Sung

2014-02-01

Since the launch of imatinib, chronic myeloid leukaemia has become a chronic condition requiring costly long-term treatment. Emerging evidence from several short-term studies has raised concerns on the detrimental clinical outcomes and waste of resources associated with poor adherence to imatinib. This study aims to evaluate the effects of long-term imatinib adherence on clinical treatment responses and mortality. This retrospective cohort study was conducted in a medical centre in southern Taiwan. Chronic myeloid leukaemia patients who were prescribed for more than 1 month of imatinib were identified and their medical charts were reviewed from the first date of imatinib prescription to the last date of medical record or upon patients' death. Patients' basic characteristics, imatinib prescriptions, results of laboratory tests, episodes of imatinib-related side effects and mortality rate were recorded. Participants' basic characteristics, medication possession ratio and their mortality rate; the association between the medication possession ratio and treatment responses. Of the 119 included patients, the mean follow-up time was 3.9 ± 2.9 patient-years and the mean medication possession ratio was 89.7 %. At the 18th month of imatinib treatment, 67.2, 54.3 and 34.5 % patients achieved complete cytogenetic, major molecular and complete molecular responses, respectively. There was a significant difference in the 4-year survival rate between the adherence (n = 87) and non-adherence (n = 32) groups (91 vs. 72 %; p = 0.0076). Logistic regression analysis revealed that imatinib adherence was the only factor that significantly influenced the 18th month complete cytogenetic response [odds ratio (OR) 11.6; 95 % confidence interval (CI) 1.7, 114.7; p = 0.0131] and major molecular response (OR 5.1; 95 % CI 1.1, 26.8; p = 0.0351). Cox regression analysis demonstrated that a medication possession ratio greater than 90 % significantly reduced the mortality risk (hazard ratio 0.1; 95 % CI 0.01, 0.60; p = 0.0118). Chronic myeloid leukaemia patients' long-term adherence to imatinib is significantly associated with the 18th month treatment responses including the cytogenetic response, molecular response and the long-term survival rate in clinical practice.

Analysis of outcomes achieved with squamous cell carcinomas of the anus in a single university hospital over the last two decades: Clinical response rate, relapse and survival of 190 patients.

PubMed

Gravante, Gianpiero; Stephenson, James Andrew; Elshaer, Mohamed; Osman, Ahmed; Vasanthan, Subramaniam; Mullineux, Joseph H; Gani, Mohamed Akil Dilawar; Sharpe, David; Yeung, Justin; Norwood, Michael; Miller, Andrew; Boyle, Kirsten; Hemingway, David

2018-02-01

We reviewed our series of anal squamous cell carcinomas (ASCC) treated over the last two decades. ASCC patients undergoing treatment at the Leicester Royal Infirmary between 1998 and 2016 were selected. Age, gender, pathological tumor characteristics, treatment adopted, the overall survival (OS), cancer-specific survival (CSS), and disease-free survival (DFS) at 5-year follow-up were recorded and calculated. A total of 190 ASCC were reviewed, of these 64.2% (n = 122) received primary radical chemoradiotherapy. Complete response rate was 92.6% (n = 113) and four patients with residual disease underwent a salvage APER. Twenty-eight patients experienced recurrent disease (23.0%) either systemic (n = 8), local (n = 14), or both (n = 6); six had a salvage APER. Complete follow-up data are available for 63.1% patients (77/122). Overall, the locoregional failure rate of primary chemoradiotherapy (residual + recurrent disease) was present in 29 patients (29/122; 23.8%). OS was 41.6% CSS was 69.2% and DFS 60.0% at 5 years follow-up. In our series of ASCC primary chemoradiotherapy had achieved significant initial complete response rates, however, long term-follow ups still present systemic and local recurrences. APR is able to treat 30% of the pelvic recurrences (6/20), the others are either associated with systemic disease or locally inoperable masses. © 2017 Wiley Periodicals, Inc.

A methodology for enhancing implementation science proposals: comparison of face-to-face versus virtual workshops.

PubMed

Marriott, Brigid R; Rodriguez, Allison L; Landes, Sara J; Lewis, Cara C; Comtois, Katherine A

2016-05-06

With the current funding climate and need for advancements in implementation science, there is a growing demand for grantsmanship workshops to increase the quality and rigor of proposals. A group-based implementation science-focused grantsmanship workshop, the Implementation Development Workshop (IDW), is one methodology to address this need. This manuscript provides an overview of the IDW structure, format, and findings regarding its utility. The IDW methodology allows researchers to vet projects in the proposal stage in a structured format with a facilitator and two types of expert participants: presenters and attendees. The presenter uses a one-page handout and verbal presentation to present their proposal and questions. The facilitator elicits feedback from attendees using a format designed to maximize the number of unique points made. After each IDW, participants completed an anonymous survey assessing perceptions of the IDW. Presenters completed a funding survey measuring grant submission and funding success. Qualitative interviews were conducted with a subset of participants who participated in both delivery formats. Mixed method analyses were performed to evaluate the effectiveness and acceptability of the IDW and compare the delivery formats. Of those who participated in an IDW (N = 72), 40 participated in face-to-face only, 16 in virtual only, and 16 in both formats. Thirty-eight (face-to-face n = 12, 35 % response rate; virtual n = 26, 66.7 % response rate) responded to the surveys and seven (15.3 % response rate), who had attended both formats, completed an interview. Of 36 total presenters, 17 (face-to-face n = 12, 42.9 % response rate; virtual n = 5, 62.9 % response rate) responded to the funding survey. Mixed method analyses indicated that the IDW was effective for collaboration and growth, effective for enhancing success in obtaining grants, and acceptable. A third (35.3 %) of presenters ultimately received funding for their proposal, and more than 80 % of those who presented indicated they would present again in the future. The IDW structure and facilitation process were found to be acceptable, with both formats rated as equally strong. The IDW presents an acceptable and successful methodology for increasing competitiveness of implementation science grant proposals.

Exploring physician specialist response rates to web-based surveys.

PubMed

Cunningham, Ceara Tess; Quan, Hude; Hemmelgarn, Brenda; Noseworthy, Tom; Beck, Cynthia A; Dixon, Elijah; Samuel, Susan; Ghali, William A; Sykes, Lindsay L; Jetté, Nathalie

2015-04-09

Survey research in healthcare is an important tool to collect information about healthcare delivery, service use and overall issues relating to quality of care. Unfortunately, physicians are often a group with low survey response rates and little research has looked at response rates among physician specialists. For these reasons, the purpose of this project was to explore survey response rates among physician specialists in a large metropolitan Canadian city. As part of a larger project to look at physician payment plans, an online survey about medical billing practices was distributed to 904 physicians from various medical specialties. The primary method for physicians to complete the survey was via the Internet using a well-known and established survey company (www.surveymonkey.com). Multiple methods were used to encourage survey response such as individual personalized email invitations, multiple reminders, and a draw for three gift certificate prizes were used to increase response rate. Descriptive statistics were used to assess response rates and reasons for non-response. Overall survey response rate was 35.0%. Response rates varied by specialty: Neurology/neurosurgery (46.6%); internal medicine (42.9%); general surgery (29.6%); pediatrics (29.2%); and psychiatry (27.1%). Non-respondents listed lack of time/survey burden as the main reason for not responding to our survey. Our survey results provide a look into the challenges of collecting healthcare research where response rates to surveys are often low. The findings presented here should help researchers in planning future survey based studies. Findings from this study and others suggest smaller monetary incentives for each individual may be a more appropriate way to increase response rates.

Alternative Reinforcer Response Cost Impacts Cocaine Choice in Humans

PubMed Central

Stoops, William W.; Lile, Joshua A.; Glaser, Paul E.A.; Hays, Lon R.; Rush, Craig R.

2011-01-01

Cocaine use disorders are an unrelenting public health concern. Behavioral treatments reduce cocaine use by providing non-drug alternative reinforcers. The purpose of this human laboratory experiment was to determine how response cost for non-drug alternative reinforcers influenced cocaine choice. Seven cocaine-using, non-treatment-seeking subjects completed a crossover, double-blind protocol in which they first sampled doses of intranasal cocaine (5, 10, 20 or 30 mg) and completed a battery of subject-rated and physiological measures. Subjects then made eight discrete choices between the sampled dose and an alternative reinforce (US$0.25). The response cost to earn a cocaine dose was always a fixed ratio (FR) of 100 responses. The response cost for the alternative reinforcer varied across sessions (FR1, FR10, FR100, FR1000). Dose-related increases were observed for cocaine choice. Subjects made fewer drug choices when the FR requirements for the alternative reinforcers were lower than that for drug relative to when the FR requirements were equal to or higher than that for drug. Intranasal cocaine also produced prototypical stimulant-like subject-rated and physiological effects (e.g., increased ratings of Like Drug; elevated blood pressure). These data demonstrate that making alternative reinforcers easier to earn reduces cocaine self-administration, which has implications for treatment efforts. PMID:22015480

Impact of different privacy conditions and incentives on survey response rate, participant representativeness, and disclosure of sensitive information: a randomized controlled trial

PubMed Central

2014-01-01

Background Anonymous survey methods appear to promote greater disclosure of sensitive or stigmatizing information compared to non-anonymous methods. Higher disclosure rates have traditionally been interpreted as being more accurate than lower rates. We examined the impact of 3 increasingly private mailed survey conditions—ranging from potentially identifiable to completely anonymous—on survey response and on respondents’ representativeness of the underlying sampling frame, completeness in answering sensitive survey items, and disclosure of sensitive information. We also examined the impact of 2 incentives ($10 versus $20) on these outcomes. Methods A 3X2 factorial, randomized controlled trial of 324 representatively selected, male Gulf War I era veterans who had applied for United States Department of Veterans Affairs (VA) disability benefits. Men were asked about past sexual assault experiences, childhood abuse, combat, other traumas, mental health symptoms, and sexual orientation. We used a novel technique, the pre-merged questionnaire, to link anonymous responses to administrative data. Results Response rates ranged from 56.0% to 63.3% across privacy conditions (p = 0.49) and from 52.8% to 68.1% across incentives (p = 0.007). Respondents’ characteristics differed by privacy and by incentive assignments, with completely anonymous respondents and $20 respondents appearing least different from their non-respondent counterparts. Survey completeness did not differ by privacy or by incentive. No clear pattern of disclosing sensitive information by privacy condition or by incentive emerged. For example, although all respondents came from the same sampling frame, estimates of sexual abuse ranged from 13.6% to 33.3% across privacy conditions, with the highest estimate coming from the intermediate privacy condition (p = 0.007). Conclusion Greater privacy and larger incentives do not necessarily result in higher disclosure rates of sensitive information than lesser privacy and lower incentives. Furthermore, disclosure of sensitive or stigmatizing information under differing privacy conditions may have less to do with promoting or impeding participants’ “honesty” or “accuracy” than with selectively recruiting or attracting subpopulations that are higher or lower in such experiences. Pre-merged questionnaires bypassed many historical limitations of anonymous surveys and hold promise for exploring non-response issues in future research. PMID:25027174

Low-Dose Radiotherapy in Indolent Lymphoma

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

Rossier, Christine; Schick, Ulrike; Miralbell, Raymond

Purpose: To assess the response rate, duration of response, and overall survival after low-dose involved-field radiotherapy in patients with recurrent low-grade lymphoma or chronic lymphocytic leukemia (CLL). Methods and Materials: Forty-three (24 women, 19 men) consecutive patients with indolent lymphoma or CLL were treated with a total dose of 4 Gy (2 x 2 Gy) using 6- 18-MV photons. The median age was 73 years (range, 39-88). Radiotherapy was given either after (n = 32; 75%) or before (n = 11; 25%) chemotherapy. The median time from diagnosis was 48 months (range, 1-249). The median follow-up period was 20 monthsmore » (range, 1-56). Results: The overall response rate was 90%. Twelve patients (28%) had a complete response, 15 (35%) had a partial response, 11 (26%) had stable disease, and 5 (11%) had progressive disease. The median overall survival for patients with a positive response (complete response/partial response/stable disease) was 41 months; for patients with progressive disease it was 6 months (p = 0.001). The median time to in-field progression was 21 months (range, 0-24), and the median time to out-field progression was 8 months (range, 0-40). The 3-year in-field control was 92% in patients with complete response (median was not reached). The median time to in-field progression was 9 months (range, 0.5-24) in patients with partial response and 6 months (range, 0.6-6) in those with stable disease (p < 0.05). Younger age, positive response to radiotherapy, and no previous chemotherapy were the best factors influencing the outcome. Conclusions: Low-dose involved-field radiotherapy is an effective treatment in the management of patients with recurrent low-grade lymphoma or CLL.« less

Automating Collection of Pain-Related Patient-Reported Outcomes to Enhance Clinical Care and Research.

PubMed

Owen-Smith, Ashli; Mayhew, Meghan; Leo, Michael C; Varga, Alexandra; Benes, Lindsay; Bonifay, Allison; DeBar, Lynn

2018-05-01

Chronic pain is highly prevalent, and the ability to routinely measure patients' pain and treatment response using validated patient-reported outcome (PRO) assessments is important to clinical care. Despite this recognition, systematic use in everyday clinical care is rare. The aims of this study were to (1) describe infrastructure designed to automate PRO data collection, (2) compare study-enhanced PRO completion rates to those in clinical care, and (3) evaluate patient response rates by method of PRO administration and sociodemographic and/or clinical characteristics. The Pain Program for Active Coping and Training (PPACT) is a pragmatic clinical trial conducted within three regions of the Kaiser Permanente health care system. PPACT evaluates the effect of integrative primary care-based pain management services on outcomes for chronic pain patients on long-term opioid treatment. We implemented a tiered process for quarterly assessment of PROs to supplement clinical collection and ensure adequate trial data using three methods: web-based personal health records (PHR), automated interactive voice response (IVR) calls, and live outreach. Among a subset of PPACT participants examined (n = 632), the tiered study-enhanced PRO completion rates were higher than in clinical care: 96% completed ≥ 1 study-administered PRO with mean of 3.46 (SD = 0.85) vs. 74% completed in clinical care with a mean of 2.43 (SD = 2.08). Among all PPACT participants at 3 months (n = 831), PRO completion was 86% and analyses of response by key characteristics found only that participant age predicted an increased likelihood of responding to PHR and IVR outreach. Adherence to pain-related PRO data collection using our enhanced tiered approach was high. No demographic or clinical identifiers other than age were associated with differential response by modality. Successful ancillary support should employ multimodal electronic health record functionalities for PRO administration. Using automated modalities is feasible and may facilitate better sustainability for regular PRO administration within health care systems. Clinical Trials Registration Number: NCT02113592.

Phenobarbital for Neonatal Seizures: Response Rate and Predictors of Refractoriness.

PubMed

Spagnoli, Carlotta; Seri, Stefano; Pavlidis, Elena; Mazzotta, Silvia; Pelosi, Annalisa; Pisani, Francesco

2016-10-01

Background Phenobarbital is the first-line choice for neonatal seizures treatment, despite a response rate of approximately 45%. Failure to respond to acute anticonvulsants is associated with poor neurodevelopmental outcome, but knowledge on predictors of refractoriness is limited. Objective To quantify response rate to phenobarbital and to establish variables predictive of its lack of efficacy. Methods We retrospectively evaluated newborns with electrographically confirmed neonatal seizures admitted between January 1999 and December 2012 to the neonatal intensive care unit of Parma University Hospital (Italy), excluding neonates with status epilepticus. Response was categorized as complete (cessation of clinical and electrographic seizures after phenobarbital administration), partial (reduction but not cessation of electrographic seizures with the first bolus, response to the second bolus), or absent (no response after the second bolus). Multivariate analysis was used to identify independent predictors of refractoriness. Results Out of 91 newborns receiving phenobarbital, 57 (62.6%) responded completely, 15 (16.5%) partially, and 19 (20.9%) did not respond. Seizure type (p = 0.02), background electroencephalogram (EEG; p ≤ 0.005), and neurologic examination (p  ≤  0.005) correlated with response to phenobarbital. However, EEG (p  ≤  0.02) and seizure type (p  ≤  0.001) were the only independent predictors. Conclusion Our results suggest a prominent role of neurophysiological variables (background EEG and electrographic-only seizure type) in predicting the absence of response to phenobarbital in high-risk newborns. Georg Thieme Verlag KG Stuttgart · New York.

Prospective pilot study of high-dose (10 mg/kg/day) liposomal amphotericin B (L-AMB) for the initial treatment of mucormycosis.

PubMed

Lanternier, F; Poiree, S; Elie, C; Garcia-Hermoso, D; Bakouboula, P; Sitbon, K; Herbrecht, R; Wolff, M; Ribaud, P; Lortholary, O

2015-11-01

Mucormycosis incidence is increasing and is associated with a high rate of mortality. Although lipid-based formulations of amphotericin B are the recommended first-line treatment, only one prospective trial in a limited number of patients has been performed to evaluate this regimen. Patients with proven or probable mucormycosis were included between June 2007 and March 2011. Patients were scheduled to receive 10 mg/kg/day liposomal amphotericin B (L-AMB) monotherapy for 1 month and surgery was performed when appropriate. The primary outcome was response rate at week 4 or at the end of treatment (EOT) if before week 4, evaluated by an independent committee. ClinicalTrials.gov Identifier: NCT00467883. Forty patients were enrolled. Response was analysed in 33 patients at week 4. Most patients had a haematological malignancy as their primary underlying disease (53%). Seventy-one percent of patients underwent therapeutic surgery. The response rate at week 4 or at EOT was 36%, with 18% partial responses and 18% complete responses. The response rate at week 12 was 45%, with 13% partial responses and 32% complete responses. Overall mortality was 38% at week 12 and 53% at week 24. Serum creatinine doubled in 16 (40%) patients and returned to normal levels within 12 weeks in 10/16 (63%). High-dose L-AMB for mucormycosis, in combination with surgery in 71% of cases, was associated with an overall response rate of 36% at week 4 and 45% at week 12 and creatinine level doubling in 40% of patients (transient in 63%). These results may serve as the basis for future clinical trials. © The Author 2015. Published by Oxford University Press on behalf of the British Society for Antimicrobial Chemotherapy. All rights reserved. For Permissions, please e-mail: journals.permissions@oup.com.

The efficacy and safety of neoadjuvant chemotherapy +/- letrozole in postmenopausal women with locally advanced breast cancer: a randomized phase III clinical trial.

PubMed

Mohammadianpanah, Mohammad; Ashouri, Yaghoub; Hoseini, Sare; Amadloo, Niloofar; Talei, Abdolrasoul; Tahmasebi, Sedigheh; Nasrolahi, Hamid; Mosalaei, Ahmad; Omidvari, Shapour; Ansari, Mansour; Mosleh-Shirazi, Mohammad Amin

2012-04-01

This two-arm randomized clinical study aimed to evaluate the efficacy and safety of neoadjuvant concurrent chemotherapy and letrozole in postmenopausal women with locally advanced breast carcinoma. One hundred and one postmenopausal women aged 50-83 years with pathologically proven locally advanced (clinical stage T3, T4 and/or N2, N3) breast cancer were randomly assigned to receive neoadjuvant chemotherapy alone (control arm, n = 51) or neoadjuvant chemotherapy concurrent with letrozole 2.5 mg (study arm, n = 50). Chemotherapy consisted of a median 4 (range 3-5) cycles of intravenous 5-fluorouracil 600 mg/m(2), doxorubicin 60 mg/m(2), and cyclophosphamide 600 mg/m(2), every three weeks. All patients subsequently underwent modified radical mastectomy approximately two weeks after the last cycle of chemotherapy. Pathologic complete response rates were 25.5% and 10.2% in the study and the control group, respectively (P = 0.049). Similarly, clinical complete response rates were 27.6% and 10.2% in the study and the control group, respectively (P = 0.037). In the subgroup analysis of hormone receptor-positive cases, the complete response rates were more prominent in study group compared with control group. Common treatment-related side effects such as nausea, vomiting, bone marrow suppression, and mucositis were similar in both groups, but hot flush was more prevalent in study group compared with control group (P = 0.023). The addition of letrozole concurrently with neoadjuvant chemotherapy provides a higher clinical and pathologic response rates with acceptable toxicity compared with chemotherapy alone in postmenopausal women with locally advanced sensitive breast cancer.

Response audit of an Internet survey of health care providers and administrators: implications for determination of response rates.

PubMed

Dobrow, Mark J; Orchard, Margo C; Golden, Brian; Holowaty, Eric; Paszat, Lawrence; Brown, Adalsteinn D; Sullivan, Terrence

2008-10-16

Internet survey modalities often compare unfavorably with traditional survey modalities, particularly with respect to response rates. Response to Internet surveys can be affected by the distribution options and response/collection features employed as well as the existence of automated (out-of-office) replies, automated forwarding, server rejection, and organizational or personal spam filters. However, Internet surveys also provide unparalleled opportunities to track study subjects and examine many of the factors influencing the determination of response rates. Tracking data available for Internet surveys provide detailed information and immediate feedback on a significant component of response that other survey modalities cannot match. This paper presents a response audit of a large Internet survey of more than 5000 cancer care providers and administrators in Ontario, Canada. Building upon the CHEcklist for Reporting Results of Internet E-Surveys (CHERRIES), the main objectives of the paper are to (a) assess the impact of a range of factors on the determination of response rates for Internet surveys and (b) recommend steps for improving published descriptions of Internet survey methods. We audited the survey response data, analyzing the factors that affected the numerator and denominator in the ultimate determination of response. We also conducted a sensitivity analysis to account for the inherent uncertainty associated with the impact of some of the factors on the response rates. The survey was initially sent out to 5636 health care providers and administrators. The determination of the numerator was influenced by duplicate/unattached responses and response completeness. The numerator varied from a maximum of 2031 crude (unadjusted) responses to 1849 unique views, 1769 participants, and 1616 complete responses. The determination of the denominator was influenced by forwarding of the invitation email to unknown individuals, server rejections, automated replies, spam filters, and 'opt out' options. Based on these factors, the denominator varied from a minimum of 5106 to a maximum of 5922. Considering the different assumptions for the numerator and the denominator, the sensitivity analysis resulted in a 12.5% variation in the response rate (from minimum of 27.3% to maximum of 39.8%) with a best estimate of 32.8%. Depending on how the numerator and denominator are chosen, the resulting response rates can vary widely. The CHERRIES statement was an important advance in identifying key characteristics of Internet surveys that can influence response rates. This response audit suggests the need to further clarify some of these factors when reporting on Internet surveys for health care providers and administrators, particularly when using commercially available Internet survey packages for specified, rather than convenience, samples.

BRCA mutations and their influence on pathological complete response and prognosis in a clinical cohort of neoadjuvantly treated breast cancer patients.

PubMed

Wunderle, Marius; Gass, Paul; Häberle, Lothar; Flesch, Vivien M; Rauh, Claudia; Bani, Mayada R; Hack, Carolin C; Schrauder, Michael G; Jud, Sebastian M; Emons, Julius; Erber, Ramona; Ekici, Arif B; Hoyer, Juliane; Vasileiou, Georgia; Kraus, Cornelia; Reis, Andre; Hartmann, Arndt; Lux, Michael P; Beckmann, Matthias W; Fasching, Peter A; Hein, Alexander

2018-05-03

BRCA1/2 mutations influence the molecular characteristics and the effects of systemic treatment of breast cancer. This study investigates the impact of germline BRCA1/2 mutations on pathological complete response and prognosis in patients receiving neoadjuvant systemic chemotherapy. Breast cancer patients were tested for a BRCA1/2 mutation in clinical routine work and were treated with anthracycline-based or platinum-based neoadjuvant chemotherapy between 1997 and 2015. These patients were identified in the tumor registry of the Breast Center of the University of Erlangen (Germany). Logistic regression and Cox regression analyses were performed to investigate the associations between BRCA1/2 mutation status, pathological complete response, disease-free survival, and overall survival. Among 355 patients, 59 had a mutation in BRCA1 or in BRCA2 (16.6%), 43 in BRCA1 (12.1%), and 16 in BRCA2 (4.5%). Pathological complete response defined as "ypT0; ypN0" was observed in 54.3% of BRCA1/2 mutation carriers, but only in 22.6% of non-carriers. The adjusted odds ratio was 2.48 (95% CI 1.26-4.91) for BRCA1/2 carriers versus non-carriers. Patients who achieved a pathological complete response had better disease-free survival and overall survival rates compared with those who did not achieve a pathological complete response, regardless of BRCA1/2 mutation status. BRCA1/2 mutation status leads to better responses to neoadjuvant chemotherapy in breast cancer. Pathological complete response is the main predictor of disease-free survival and overall survival, independently of BRCA1/2 mutation status.

Short Stay Summary Report, Spring 2003.

ERIC Educational Resources Information Center

Okanagan Coll., Kelowan (British Columbia).

This 2003 study was designed to collect data on the outcomes of short stay students, or former students who leave British Columbia's colleges, university colleges, and institutes after completing between 9 and 23 credits. Out of 2,273 former students eligible for surveying, 871 completed the survey, for a response rate of 38%. The survey collected…

Student Evaluation of Teaching: An Investigation of Nonresponse Bias in an Online Context

ERIC Educational Resources Information Center

Reisenwitz, Timothy H.

2016-01-01

The online administration of student evaluations has its shortcomings, including low participation, or low response rates, and bias. This study examines nonresponse bias in online student evaluations of instruction, that is, the differences between those students who complete online evaluations and those who decide not to complete them. It builds…

A randomized controlled trial comparing EMDR and CBT for obsessive-compulsive disorder.

PubMed

Marsden, Zoe; Lovell, Karina; Blore, David; Ali, Shehzad; Delgadillo, Jaime

2018-01-01

This study aimed to evaluate eye movement desensitization and reprocessing (EMDR) as a treatment for obsessive-compulsive disorder (OCD), by comparison to cognitive behavioural therapy (CBT) based on exposure and response prevention. This was a pragmatic, feasibility randomized controlled trial in which 55 participants with OCD were randomized to EMDR (n = 29) or CBT (n = 26). The Yale-Brown obsessive-compulsive scale was completed at baseline, after treatment and at 6 months follow-up. Treatment completion and response rates were compared using chi-square tests. Effect size was examined using Cohen's d and multilevel modelling. Overall, 61.8% completed treatment and 30.2% attained reliable and clinically significant improvement in OCD symptoms, with no significant differences between groups (p > .05). There were no significant differences between groups in Yale-Brown obsessive-compulsive scale severity post-treatment (d = -0.24, p = .38) or at 6 months follow-up (d = -0.03, p = .90). EMDR and CBT had comparable completion rates and clinical outcomes. Copyright © 2017 John Wiley & Sons, Ltd.

Reliability of Heart Rate Responses at Given Ratings of Perceived Exertion in Cycling and Walking

ERIC Educational Resources Information Center

Katsanos, Christos S.; Moffatt, Robert J.

2005-01-01

Eleven healthy men (M age = 27 years, SD = 4) completed three cycling and three walking trials in an alternating order. During each trial, participants were allowed, within 3 min, to adjust the work rate to correspond to given rating of perceived exertion (RPE) values according to the following order: RPE 11, 13, and 15. For cycling as well as…

Meta-Analysis of the Safety and Efficacy of Interferon Combined With Dacarbazine Versus Dacarbazine Alone in Cutaneous Malignant Melanoma.

PubMed

Xin, Yong; Huang, Qian; Zhang, Pei; Yang, Ming; Hou, Xiao-Yang; Tang, Jian-Qin; Zhang, Long Zhen; Jiang, Guan

2016-04-01

The aim of this study was to compare the efficacy and safety of interferon (IFN) combined with dacarbazine (DTIC) (experimental group) versus DTIC alone (control group) in cutaneous malignant melanoma. After searching all available databases, eligible articles were identified and subjected to quality assessment. Meta-analysis was performed using RevMan 5.3; combined relative risk (RR) and 95% confidence intervals (95% CIs) were calculated for survival rates, response rates, and adverse events. Eight randomized controlled trials published between 1990 and 2014 involving 795 patients were included in the meta-analysis. Compared with DTIC alone, IFN combined with DTIC significantly increased the overall response rate (RR = 1.59, 95% CI 1.21-2.08, P = 0.0008),the complete response rate (RR = 3.30, 95% CI 1.89-5.76, P < 0.0001), 2-year survival (RR = 1.59, 95% CI 0.99-2.54, P = 0.050) grade ≥3 hematologic toxicity (RR = 2.30, 95% CI 1.32-4.02, P = 0.003), neurotoxicity (RR = 18.15, 95% CI 5.34-61.74, P < 0.00001), and flu-like symptoms (RR = 6.31, 95% CI 1.95-20.39, P = 0.002). The partial response rate, grade ≥3 nausea and vomiting, treatment-related, and 1- and 3-year survival were not significantly different between IFN combined with DTIC and DTIC alone. IFN combined with DTIC may moderately improve the complete response rate, but increases the incidence of adverse events and has no significant effect on 1- and 3-year survival in cutaneous malignant melanoma.

Meta-Analysis of the Safety and Efficacy of Interferon Combined With Dacarbazine Versus Dacarbazine Alone in Cutaneous Malignant Melanoma

PubMed Central

Xin, Yong; Huang, Qian; Zhang, Pei; Yang, Ming; Hou, Xiao-Yang; Tang, Jian-Qin; Zhang, Long Zhen; Jiang, Guan

2016-01-01

Abstract The aim of this study was to compare the efficacy and safety of interferon (IFN) combined with dacarbazine (DTIC) (experimental group) versus DTIC alone (control group) in cutaneous malignant melanoma. After searching all available databases, eligible articles were identified and subjected to quality assessment. Meta-analysis was performed using RevMan 5.3; combined relative risk (RR) and 95% confidence intervals (95% CIs) were calculated for survival rates, response rates, and adverse events. Eight randomized controlled trials published between 1990 and 2014 involving 795 patients were included in the meta-analysis. Compared with DTIC alone, IFN combined with DTIC significantly increased the overall response rate (RR = 1.59, 95% CI 1.21–2.08, P = 0.0008),the complete response rate (RR = 3.30, 95% CI 1.89–5.76, P < 0.0001), 2-year survival (RR = 1.59, 95% CI 0.99–2.54, P = 0.050) grade ≥3 hematologic toxicity (RR = 2.30, 95% CI 1.32–4.02, P = 0.003), neurotoxicity (RR = 18.15, 95% CI 5.34–61.74, P < 0.00001), and flu-like symptoms (RR = 6.31, 95% CI 1.95–20.39, P = 0.002). The partial response rate, grade ≥3 nausea and vomiting, treatment-related, and 1- and 3-year survival were not significantly different between IFN combined with DTIC and DTIC alone. IFN combined with DTIC may moderately improve the complete response rate, but increases the incidence of adverse events and has no significant effect on 1- and 3-year survival in cutaneous malignant melanoma. PMID:27100429

Advantages of concurrent biochemotherapy modified by decrescendo interleukin-2, granulocyte colony-stimulating factor, and tamoxifen for patients with metastatic melanoma.

PubMed

O'Day, S J; Gammon, G; Boasberg, P D; Martin, M A; Kristedja, T S; Guo, M; Stern, S; Edwards, S; Fournier, P; Weisberg, M; Cannon, M; Fawzy, N W; Johnson, T D; Essner, R; Foshag, L J; Morton, D L

1999-09-01

Concurrent biochemotherapy results in high response rates but also significant toxicity in patients with metastatic melanoma. We attempted to improve its efficacy and decrease its toxicity by using decrescendo dosing of interleukin-2 (IL-2), posttreatment granulocyte colony-stimulating factor (G-CSF), and low-dose tamoxifen. Forty-five patients with poor prognosis metastatic melanoma were treated at a community hospital inpatient oncology unit affiliated with the John Wayne Cancer Institute (Santa Monica, CA) between July 1995 and September 1997. A 5-day modified concurrent biochemotherapy regimen of dacarbazine, vinblastine, cisplatin, decrescendo IL-2, interferon alfa-2b, and tamoxifen was repeated at 21-day intervals. G-CSF was administered beginning on day 6 for 7 to 10 days. The overall response rate was 57% (95% confidence interval, 42% to 72%), the complete response rate was 23%, and the partial response rate was 34%. Complete remissions were achieved in an additional 11% of patients by surgical resection of residual disease after biochemotherapy. The median time to progression was 6.3 months and the median duration of survival was 11.4 months. At a maximum follow-up of 36 months (range, 10 to 36 months), 32% of patients are alive and 14% remain free of disease. Decrescendo IL-2 dosing and administration of G-CSF seemed to reduce toxicity, length of hospital stay, and readmission rates. No patient required intensive care unit monitoring, and there were no treatment-related deaths. The data from this study indicate that the modified concurrent biochemotherapy regimen reduces the toxicity of concurrent biochemotherapy with no apparent decrease in response rate in patients with poor prognosis metastatic melanoma.

Prospective study of rabbit antithymocyte globulin and cyclosporine for aplastic anemia from the EBMT Severe Aplastic Anaemia Working Party.

PubMed

Marsh, Judith C; Bacigalupo, Andrea; Schrezenmeier, Hubert; Tichelli, Andre; Risitano, Antonio M; Passweg, Jakob R; Killick, Sally B; Warren, Alan J; Foukaneli, Theodora; Aljurf, Mahmoud; Al-Zahrani, H A; Höchsmann, Britta; Schafhausen, Philip; Roth, Alexander; Franzke, Anke; Brummendorf, Tim H; Dufour, Carlo; Oneto, Rosi; Sedgwick, Philip; Barrois, Alain; Kordasti, Shahram; Elebute, Modupe O; Mufti, Ghulam J; Socie, Gerard

2012-06-07

Rabbit antithymocyte globulin (rATG; thymoglobulin, Genzyme) in combination with cyclosporine, as first-line immunosuppressive therapy, was evaluated prospectively in a multicenter, European, phase 2 pilot study, in 35 patients with aplastic anemia. Results were compared with 105 age- and disease severity-matched patients from the European Blood and Marrow Transplant registry, treated with horse ATG (hATG; lymphoglobulin) and cyclosporine. The primary end point was response at 6 months. At 3 months, no patients had achieved a complete response to rATG. Partial response occurred in 11 (34%). At 6 months, complete response rate was 3% and partial response rate 37%. There were 10 deaths after rATG (28.5%) and 1 after subsequent HSCT. Infections were the main cause of death in 9 of 10 patients. The best response rate was 60% for rATG and 67% for hATG. For rATG, overall survival at 2 years was 68%, compared with 86% for hATG (P = .009). Transplant-free survival was 52% for rATG and 76% for hATG (P = .002). On multivariate analysis, rATG (hazard ratio = 3.9, P = .003) and age more than 37 years (hazard ratio = 4.7, P = .0008) were independent adverse risk factors for survival. This study was registered at www.clinicaltrials.gov as NCT00471848.

Association of ABCB1 polymorphisms with the antiemetic efficacy of granisetron plus dexamethasone in breast cancer patients.

PubMed

Tsuji, Daiki; Kim, Yong-Il; Nakamichi, Hidenori; Daimon, Takashi; Suwa, Kaori; Iwabe, Yutaro; Hayashi, Hideki; Inoue, Kazuyuki; Yoshida, Masayuki; Itoh, Kunihiko

2013-01-01

Resistance to antiemetic treatment with 5-hydroxytryptamine 3 receptor antagonists is a problem, with 20-30% of patients showing unsatisfactory responses. Efflux transport by P-glycoprotein, encoded by the ATP-binding cassette ABCB1 gene in the blood-brain barrier, has been the suggested resistance mechanism. We evaluated the association between the antiemetic efficacy of granisetron plus dexamethasone and ABCB1 polymorphisms 3435C>T and 2677G>T/A. Sixty-four breast cancer patients treated with doxorubicin plus cyclophosphamide were evaluated for their responses to antiemetic therapy. Genotyping of patient DNA samples for ABCB1 single nucleotide polymorphisms was performed; the genotypes were then investigated for their association with the efficacy of prophylactic antiemetics. The acute phase complete response rate was 83% in GG subjects (n = 12), and 69% (n = 35) and 41% (n = 17) in heterozygous and homozygous carriers of the 2677T/A allele, respectively (p = 0.047). The ABCB1 2677 TT genotype group showed significantly lower rates of complete control of acute emesis than the group with GG genotypes (p = 0.045). No significant association with complete response was found for 3435C>T (p = 0.190). ABCB1 polymorphisms may influence the extent of acute emesis control in granisetron-treated patients, making the ABCB1 genotype a predictor of prophylactic antiemetic response.

Ibrutinib plus Venetoclax for the Treatment of Mantle-Cell Lymphoma.

PubMed

Tam, Constantine S; Anderson, Mary Ann; Pott, Christiane; Agarwal, Rishu; Handunnetti, Sasanka; Hicks, Rodney J; Burbury, Kate; Turner, Gillian; Di Iulio, Juliana; Bressel, Mathias; Westerman, David; Lade, Stephen; Dreyling, Martin; Dawson, Sarah-Jane; Dawson, Mark A; Seymour, John F; Roberts, Andrew W

2018-03-29

Both the BTK inhibitor ibrutinib and the BCL2 inhibitor venetoclax are active as monotherapy in the treatment of mantle-cell lymphoma. Complete response rates of 21% have been observed for each agent when administered as long-term continuous therapy. Preclinical models predict synergy in combination. We conducted a single-group, phase 2 study of daily oral ibrutinib and venetoclax in patients, as compared with historical controls. Patients commenced ibrutinib monotherapy at a dose of 560 mg per day. After 4 weeks, venetoclax was added in stepwise, weekly increasing doses to 400 mg per day. Both drugs were continued until progression or an unacceptable level of adverse events. The primary end point was the rate of complete response at week 16. Minimal residual disease (MRD) was assessed by flow cytometry in bone marrow and by allele-specific oligonucleotide-polymerase chain reaction (ASO-PCR) in blood. The study included 24 patients with relapsed or refractory mantle-cell lymphoma (23 patients) or previously untreated mantle-cell lymphoma (1 patient). Patients were 47 to 81 years of age, and the number of previous treatments ranged from none to six. Half the patients had aberrations of TP53, and 75% had a high-risk prognostic score. The complete response rate according to computed tomography at week 16 was 42%, which was higher than the historical result of 9% at this time point with ibrutinib monotherapy (P<0.001). The rate of complete response as assessed by positron-emission tomography was 62% at week 16 and 71% overall. MRD clearance was confirmed by flow cytometry in 67% of the patients and by ASO-PCR in 38%. In a time-to-event analysis, 78% of the patients with a response were estimated to have an ongoing response at 15 months. The tumor lysis syndrome occurred in 2 patients. Common side effects were generally low grade and included diarrhea (in 83% of the patients), fatigue (in 75%), and nausea or vomiting (in 71%). In this study involving historical controls, dual targeting of BTK and BCL2 with ibrutinib and venetoclax was consistent with improved outcomes in patients with mantle-cell lymphoma who had been predicted to have poor outcomes with current therapy. (Funded by Janssen and others; AIM ClinicalTrials.gov number, NCT02471391 .).

An international cross-sectional survey on the Quality and Costs of Primary Care (QUALICO-PC): recruitment and data collection of places delivering primary care across Canada.

PubMed

Wong, Sabrina T; Chau, Leena W; Hogg, William; Teare, Gary F; Miedema, Baukje; Breton, Mylaine; Aubrey-Bassler, Kris; Katz, Alan; Burge, Fred; Boivin, Antoine; Cooke, Tim; Francoeur, Danièle; Wodchis, Walter P

2015-02-18

Performance reporting in primary health care in Canada is challenging because of the dearth of concise and synthesized information. The paucity of information occurs, in part, because the majority of primary health care in Canada is delivered through a multitude of privately owned small businesses with no mechanism or incentives to provide information about their performance. The purpose of this paper is to report the methods used to recruit family physicians and their patients across 10 provinces to provide self-reported information about primary care and how this information could be used in recruitment and data collection for future large scale pan-Canadian and other cross-country studies. Canada participated in an international large scale study-the QUALICO-PC (Quality and Costs of Primary Care) study. A set of four surveys, designed to collect in-depth information regarding primary care activities was collected from: practices, providers, and patients (experiences and values). Invitations (telephone, electronic or mailed) were sent to family physicians. Eligible participants were sent a package of surveys. Provincial teams kept records on the number of: invitation emails/letters sent, physicians who registered, practices that were sent surveys, and practices returning completed surveys. Response and cooperation rates were calculated. Invitations to participate were sent to approximately 23,000 family physicians across Canada. A total of 792 physicians and 8,332 patients from 772 primary care practices completed the surveys, including 1,160 participants completing a Patient Values survey and 7,172 participants completing a Patient Experience survey. Overall, the response rate was very low ranging from 2% (British Columbia) to 21% (Nova Scotia). However, the participation rate was high, ranging from 72% (Ontario) to 100% (New Brunswick/Prince Edward Island and Newfoundland & Labrador). The difficulties obtaining acceptable response rates by family physicians for survey participation is a universal challenge. This response rate for the QUALICO-PC arm in Canada was similar to rates found in other countries such as Australia and New Zealand. Even though most family physicians operate as self-employed small businesses, they could be supported to routinely submit data through a collective effort and provincial mandate. The groundwork in setting up pan-Canadian collaboration in primary care has been established through this study.

'Real-life' study of imatinib therapy in chronic phase-chronic myeloid leukemia: A novel retrospective observational longitudinal analysis.

PubMed

Merante, Serena; Ferretti, Virginia; Elena, Chiara; Calvello, Celeste; Rocca, Barbara; Zappatore, Rita; Cavigliano, Paola; Orlandi, Ester

2017-01-01

Imatinib is a cornerstone of treatment of chronic myeloid leukemia. It remains unclear whether transient treatment discontinuation or dose changes affect outcome and this approach has not yet been approved for use outside clinical trials. We conducted a retrospective single-institution observational study to evaluate factors affecting response in 'real-life' clinical practice in 138 chronic myeloid leukemia patients in chronic phase treated with imatinib. We used a novel longitudinal data analytical model, with a generalized estimating equation model, to study BCR-ABL variation according to continuous standard dose, change in dose or discontinuation; BCR-ABL transcript levels were recorded. Treatment history was subdivided into time periods for which treatment was given at constant dosage (total 483 time periods). Molecular and cytogenetic complete response was observed after 154 (32%) and 358 (74%) time periods, respectively. After adjusting for length of time period, no association between dose and cytogenetic complete response rate was observed. There was a significantly lower molecular complete response rate after time periods at a high imatinib dosage. This statistical approach can identify individual patient variation in longitudinal data collected over time and suggests that changes in dose or discontinuation of therapy could be considered in patients with appropriate biological characteristics.

Adding Postal Follow-Up to a Web-Based Survey of Primary Care and Gastroenterology Clinic Physician Chiefs Improved Response Rates but not Response Quality or Representativeness.

PubMed

Partin, Melissa R; Powell, Adam A; Burgess, Diana J; Haggstrom, David A; Gravely, Amy A; Halek, Krysten; Bangerter, Ann; Shaukat, Aasma; Nelson, David B

2015-09-01

This study assessed whether postal follow-up to a web-based physician survey improves response rates, response quality, and representativeness. We recruited primary care and gastroenterology chiefs at 125 Veterans Affairs medical facilities to complete a 10-min web-based survey on colorectal cancer screening and diagnostic practices in 2010. We compared response rates, response errors, and representativeness in the primary care and gastroenterology samples before and after adding postal follow-up. Adding postal follow-up increased response rates by 20-25 percentage points; markedly greater increases than predicted from a third e-mail reminder. In the gastroenterology sample, the mean number of response errors made by web responders (0.25) was significantly smaller than the mean number made by postal responders (2.18), and web responders provided significantly longer responses to open-ended questions. There were no significant differences in these outcomes in the primary care sample. Adequate representativeness was achieved before postal follow-up in both samples, as indicated by the lack of significant differences between web responders and the recruitment population on facility characteristics. We conclude adding postal follow-up to this web-based physician leader survey improved response rates but not response quality or representativeness. © The Author(s) 2013.

Predictors of outcome in patients with advanced nonseminomatous germ cell testicular tumors.

PubMed

Yetisyigit, Tarkan; Babacan, Nalan; Urun, Yuksel; Seber, Erdogan Selcuk; Cihan, Sener; Arpaci, Erkan; Yildirim, Nuriye; Aksoy, Sercan; Budakoglu, Burcin; Zengin, Nurullah; Oksuzoglu, Berna; Yalcin, Banu Cicek; Alkis, Necati

2014-01-01

Predictor factors determining complete response to treatment are still not clearly defined. We aimed to evaluate clinicopathological features, risk factors, treatment responses, and survival analysis of patient with advanced nonseminomatous GCTs (NSGCTs). Between November 1999 and September 2011, 140 patients with stage II and III NSGCTs were referred to our institutions and 125 patients with complete clinical data were included in this retrospective study. Four cycles of BEP regimen were applied as a first-line treatment. Salvage chemotherapy and/or high-dose chemotherapy (HDCT) with autologous stem cell transplantation were given in patients who progressed after BEP chemotherapy. Post-chemotherapy surgery was performed in selected patients with incomplete radiographic response and normal tumor markers. The median age was 28 years. For the good, intermediate and poor risk groups, compete response rates (CRR) were, 84.6%, 67.9% and 59.4%, respectively. Extragonadal tumors, stage 3 disease, intermediate and poor risk factors, rete testis invasion were associated with worse outcomes. There were 32 patients (25.6%) with non-CR who were treated with salvage treatment. Thirty-one patients died from GCTs and 94% of them had stage III disease. Even though response rates are high, some patients with GCTs still need salvage treatment and cure cannot be achieved. Non-complete response to platinium-based first-line treatment is a negative prognostic factor. Our study confirmed the need for a prognostic and predictive model and more effective salvage approaches.

Response rates and survival times for cats with lymphoma treated with the University of Wisconsin-Madison chemotherapy protocol: 38 cases (1996-2003).

PubMed

Milner, Rowan J; Peyton, Jamie; Cooke, Kirsten; Fox, Leslie E; Gallagher, Alexander; Gordon, Patti; Hester, Juli

2005-10-01

To determine response rates and survival times for cats with lymphoma treated with the University of Wisconsin-Madison chemotherapy protocol. Retrospective study. 38 cats with lymphoma. Medical records were reviewed, and information on age, sex, breed, FeLV and FIV infection status, anatomic form, clinical stage, and survival time was obtained. Immunophenotyping was not performed. Mean +/- SD age of the cats was 10.9 +/- 4.4 years. Overall median survival time was 210 days (interquartile range, 90 to 657 days), and overall duration of first remission was 156 days (interquartile range, 87 to 316 days). Age, sex, anatomic form, and clinical stage were not significantly associated with duration of first remission or survival time. Eighteen of the 38 (47%) cats had complete remission, 14 (37%) had partial remission, and 6 (16%) had no response. Duration of first remission was significantly longer for cats with complete remission (654 days) than for cats with partial remission (114 days). Median survival time for cats with complete remission (654 days) was significantly longer than median survival time for cats with partial remission (122 days) and for cats with no response (11 days). Results suggested that a high percentage of cats with lymphoma will respond to treatment with the University of Wisconsin-Madison chemotherapy protocol. Age, sex, anatomic form, and clinical stage were not significantly associated with duration of first response or survival time, but initial response to treatment was.

Response rate, response time, and economic costs of survey research: A randomized trial of practicing pharmacists.

PubMed

Hardigan, Patrick C; Popovici, Ioana; Carvajal, Manuel J

2016-01-01

There is a gap between increasing demands from pharmacy journals, publishers, and reviewers for high survey response rates and the actual responses often obtained in the field by survey researchers. Presumably demands have been set high because response rates, times, and costs affect the validity and reliability of survey results. Explore the extent to which survey response rates, average response times, and economic costs are affected by conditions under which pharmacist workforce surveys are administered. A random sample of 7200 U.S. practicing pharmacists was selected. The sample was stratified by delivery method, questionnaire length, item placement, and gender of respondent for a total of 300 observations within each subgroup. A job satisfaction survey was administered during March-April 2012. Delivery method was the only classification showing significant differences in response rates and average response times. The postal mail procedure accounted for the highest response rates of completed surveys, but the email method exhibited the quickest turnaround. A hybrid approach, consisting of a combination of postal and electronic means, showed the least favorable results. Postal mail was 2.9 times more cost effective than the email approach and 4.6 times more cost effective than the hybrid approach. Researchers seeking to increase practicing pharmacists' survey participation and reduce response time and related costs can benefit from the analytical procedures tested here. Copyright © 2016 Elsevier Inc. All rights reserved.

Phase 1 and 2 study of carboplatin and pralatrexate in patients with recurrent, platinum-sensitive ovarian, fallopian tube, or primary peritoneal cancer.

PubMed

Del Carmen, Marcela G; Supko, Jeff G; Horick, Nora K; Rauh-Hain, J Alejandro; Clark, Rachel M; Campos, Susana M; Krasner, Carolyn N; Atkinson, Tina; Birrer, Michael J

2016-11-15

The objective of this phase 1 and 2 trial was to identify the appropriate dose of combined carboplatin and pralatrexate for patients with recurrent, platinum-sensitive ovarian, fallopian tube, and primary peritoneal cancer. In phase 1, patients received carboplatin (at an area under the curve of 5) and increasing doses of pralatrexate until the maximum-tolerated dose (MTD) of pralatrexate was achieved. The primary endpoint was the response rate. Additional endpoints were safety, response duration, progression-free survival, overall survival, and pharmacokinetics. Thirty patients were enrolled in phase 1, and 20 were enrolled in phase 2. Of all 50 patients, 49 completed the study. The mean patient age was 59 years, and patients completed a median of 6 cycles. The MTD for pralatrexate was 105 mg/m 2 . The clinical benefit rate (complete responses plus partial responses plus stable disease) was 86%. Of 26 patients who received the MTD, 12 had a partial response, 11 had stable disease, and 2 had disease progression. The progression-free survival rate at 3 and 6 months was 87% and 79%, respectively; and the overall survival rate was 98% at 6 and 12 months and 66% at 24 months. Of 30 patients, 18 (60%) in phase 1 experienced an adverse event of any grade; and, of those, 4 patients (13%) had a grade 3 or greater adverse event. In phase 2, 12 patients (60%) had an adverse event of any grade, and 4 (20%) had grade 3 or greater toxicity. There was a significant reduction in the total body clearance of pralatrexate when it was received concurrently with carboplatin. Most patients responded to carboplatin-pralatrexate combination. This regimen is well tolerated and effective in this patient population. Cancer 2016;122:3297-3306. © 2016 American Cancer Society. © 2016 American Cancer Society.

Improved survival and complete response rates in patients with advanced melanoma treated with concurrent ipilimumab and radiotherapy versus ipilimumab alone.

PubMed

Koller, Kristian M; Mackley, Heath B; Liu, Jason; Wagner, Henry; Talamo, Giampaolo; Schell, Todd D; Pameijer, Colette; Neves, Rogerio I; Anderson, Bryan; Kokolus, Kathleen M; Mallon, Carol A; Drabick, Joseph J

2017-01-02

There is a growing body of evidence supporting the synergistic roles of radiotherapy and immunotherapy in the treatment of malignancy. Published case studies of the abscopal effect have been reported with the use of ipilimumab and radiotherapy in metastatic melanoma, but evidence supporting the routine use of this combination of therapy is limited. We conducted a retrospective analysis to evaluate patients treated with ipilimumab for advanced melanoma at a single institution from May 2011 to June 2015. Patients were grouped into those who had received concurrent radiotherapy while on ipilimumab (Ipi-RT), and those who did not. We then evaluated the treatment response following completion of ipilimumab. A total of 101 patients received ipilimumab in the prespecified time frame. 70 received Ipi-RT and 31 received ipilimumab without concurrent radiotherapy. Median overall survival (OS) was significantly increased in the concurrent Ipi-RT arm at 19 months vs. 10 months for ipilimumab alone (p = 0.01). Median progression free survival (PFS) was marginally increased in the Ipi-RT group compare with the ipilimumab alone group (5 months vs. 3 months, p = 0.20). Rates of complete response (CR) were significantly increased in the Ipi-RT group vs. ipilimumab alone (25.7% vs. 6.5%; p = 0.04), and rates of overall response (OR) in the groups were 37.1% vs. 19.4% (p = 0.11). No increase in toxicities was observed in the Ipi-RT group compare with ipilimumab alone. Prospective trials are needed to further clarify the role of radiotherapy with ipilimumab, but these encouraging preliminary observations suggest that this combination can induce more durable responses to immunotherapy.

Improved survival and complete response rates in patients with advanced melanoma treated with concurrent ipilimumab and radiotherapy versus ipilimumab alone

PubMed Central

Koller, Kristian M.; Mackley, Heath B.; Liu, Jason; Wagner, Henry; Talamo, Giampaolo; Schell, Todd D.; Pameijer, Colette; Neves, Rogerio I.; Anderson, Bryan; Kokolus, Kathleen M.; Mallon, Carol A.; Drabick, Joseph J.

2017-01-01

ABSTRACT There is a growing body of evidence supporting the synergistic roles of radiotherapy and immunotherapy in the treatment of malignancy. Published case studies of the abscopal effect have been reported with the use of ipilimumab and radiotherapy in metastatic melanoma, but evidence supporting the routine use of this combination of therapy is limited. We conducted a retrospective analysis to evaluate patients treated with ipilimumab for advanced melanoma at a single institution from May 2011 to June 2015. Patients were grouped into those who had received concurrent radiotherapy while on ipilimumab (Ipi-RT), and those who did not. We then evaluated the treatment response following completion of ipilimumab. A total of 101 patients received ipilimumab in the prespecified time frame. 70 received Ipi-RT and 31 received ipilimumab without concurrent radiotherapy. Median overall survival (OS) was significantly increased in the concurrent Ipi-RT arm at 19 months vs. 10 months for ipilimumab alone (p = 0.01). Median progression free survival (PFS) was marginally increased in the Ipi-RT group compare with the ipilimumab alone group (5 months vs. 3 months, p = 0.20). Rates of complete response (CR) were significantly increased in the Ipi-RT group vs. ipilimumab alone (25.7% vs. 6.5%; p = 0.04), and rates of overall response (OR) in the groups were 37.1% vs. 19.4% (p = 0.11). No increase in toxicities was observed in the Ipi-RT group compare with ipilimumab alone. Prospective trials are needed to further clarify the role of radiotherapy with ipilimumab, but these encouraging preliminary observations suggest that this combination can induce more durable responses to immunotherapy. PMID:27905824

Breast Cancer Diagnosis Using Ultrasound and Diffusive Light

DTIC Science & Technology

2004-08-01

been widely used in clinical studies. The fundamental problem remains the intense light scattering in tissue, which makes the lesion localization...Our 3 unique approach may have significant clinical applications on 1) breast cancer diagnosis; and 2) assessing treatment response and estimating...the response of cancers to presurgical chemotherapy are not completely understood [20]. Although recent trials reported clinical response rates >70

Response-to-Intervention in California Public Schools: Has It Helped Address Disproportional Placement Rates for Students with Learning Disabilities?

ERIC Educational Resources Information Center

Bouman, Sam H.

2010-01-01

Response-to-intervention (RTI) as applied in several California school districts was investigated by analyzing responses to questionnaires completed by 190 school psychologists representing 142 school districts. This analysis targeted the depth and breadth of RTI in these public K-12 school districts. A majority (80.7%) of the respondents…

Determinants of response to a parent questionnaire about development and behaviour in 3 year olds: European multicentre study of congenital toxoplasmosis

PubMed Central

Salt, A; Freeman, K; Prusa, A; Ferret, N; Buffolano, W; Malm, G; Schmidt, D; Tan, HK; Gilbert, RE

2005-01-01

Background We aimed to determine how response to a parent-completed postal questionnaire measuring development, behaviour, impairment, and parental concerns and anxiety, varies in different European centres. Methods Prospective cohort study of 3 year old children, with and without congenital toxoplasmosis, who were identified by prenatal or neonatal screening for toxoplasmosis in 11 centres in 7 countries. Parents were mailed a questionnaire that comprised all or part of existing validated tools. We determined the effect of characteristics of the centre and child on response, age at questionnaire completion, and response to child drawing tasks. Results The questionnaire took 21 minutes to complete on average. 67% (714/1058) of parents responded. Few parents (60/1058) refused to participate. The strongest determinants of response were the score for organisational attributes of the study centre (such as direct involvement in follow up and access to an address register), and infection with congenital toxoplasmosis. Age at completion was associated with study centre, presence of neurological abnormalities in early infancy, and duration of prenatal treatment. Completion rates for individual questions exceeded 92% except for child completed drawings of a man (70%), which were completed more by girls, older children, and in certain centres. Conclusion Differences in response across European centres were predominantly related to the organisation of follow up and access to correct addresses. The questionnaire was acceptable in all six countries and offers a low cost tool for assessing development, behaviour, and parental concerns and anxiety, in multinational studies. PMID:15998464

Catatonia Education: Needs Assessment and Brief Online Intervention.

PubMed

Cooper, Joseph J; Roig Llesuy, Joan

2017-06-01

There are no studies investigating physicians' knowledge of catatonia. The authors aimed to assess and increase physicians' awareness of catatonia. A survey with clinical questions about catatonia was administered, followed by a brief online teaching module about catatonia and a post-education survey. Twenty-one psychiatry residents (response rate, 70%) and 36 internal medicine residents (response rate, 34%) participated in the pre-education survey. Psychiatry residents identified 75% of the correct answers about catatonia, compared to 32% correct by internal medicine residents (p < 0.001). Twenty participants (response rate, 35%) completed the online education module and second survey, which resulted in a significant improvement in correct response rates from 60 to 83% in all the participants (p < 0.001). Residents' baseline knowledge of catatonia is low, particularly among internal medicine residents. A brief online module improved resident physicians' knowledge of catatonia. Educational strategies to improve recognition of catatonia should be implemented.

Results of a Phase II Trial of Brentuximab Vedotin for CD30+ Cutaneous T-Cell Lymphoma and Lymphomatoid Papulosis.

PubMed

Duvic, Madeleine; Tetzlaff, Michael T; Gangar, Pamela; Clos, Audra L; Sui, Dawen; Talpur, Rakhshandra

2015-11-10

Brentuximab vedotin, a monoclonal antibody (cAC10) conjugated to monomethyl auristatin E, targets CD30(+) receptors. This phase II open-label trial was conducted to evaluate safety and efficacy in CD30(+) cutaneous T-cell lymphomas. Forty-eight patients with CD30(+) lymphoproliferative disorders or mycosis fungoides (MF) received an infusion of 1.8 mg/kg every 21 days. Forty-eight evaluable patients (22 women and 26 men; median age, 59.5 years) had an overall response rate of 73% (95% CI, 60% to 86%; 35 of 48 patients) and complete response rate of 35% (95% CI, 22% to 49%; 17 of 48 patients). Fifteen (54%; 95% CI, 31% to 59%) of 28 patients with MF responded, independent of CD30 expression. In patients with MF/Sézary syndrome, the overall response rate was 50% (five of 10 patients) in patients with low CD30 expression (< 10%), 58% (seven of 12 patients) in patients with medium expression (10% to 50%), and 50% (three of six patients) in patients with high expression (≥ 50%). Time to response was 12 weeks (range, 3 to 39 weeks), and duration of response was 32 weeks (range, 3 to 93 weeks). All patients with lymphomatoid papulosis (n = 9) and primary cutaneous anaplastic T-cell lymphomas (n = 2) responded; time to response was 3 weeks (range, 3 to 9 weeks), and median duration of response was 26 weeks (range, 6 to 44 weeks). Soluble baseline CD30 levels were lowest in complete responders (P = .036). Grade 1 to 2 peripheral neuropathy was observed in 65% of patients (95% CI, 52% to 79%; 31 of 48 patients), is still ongoing in 55% of patients (95% CI, 41% to 69%; 17 of 31 patients), and resolved in 45% of patients (95% CI, 31% to 59%; 14 of 31 patients), with a median time to resolution of 41.5 weeks. Grade 3 to 4 events were neutropenia (n = 5), nausea (n = 2), chest pain (n = 2), deep vein thrombosis (n = 1), transaminitis (n = 1), and dehydration (n = 1). Dose reductions to 1.2 mg/kg were instituted as a result of grade 2 neuropathy (n = 6), transaminitis (n = 1), and arthralgias and fatigue (n = 2). Brentuximab vedotin is both active and well tolerated in cutaneous T-cell lymphoma and lymphomatoid papulosis, with an overall response rate of 73% and complete response rate of 35%. © 2015 by American Society of Clinical Oncology.

Results of a Phase II Trial of Brentuximab Vedotin for CD30+ Cutaneous T-Cell Lymphoma and Lymphomatoid Papulosis

PubMed Central

Duvic, Madeleine; Tetzlaff, Michael T.; Gangar, Pamela; Clos, Audra L.; Sui, Dawen; Talpur, Rakhshandra

2015-01-01

Purpose Brentuximab vedotin, a monoclonal antibody (cAC10) conjugated to monomethyl auristatin E, targets CD30+ receptors. This phase II open-label trial was conducted to evaluate safety and efficacy in CD30+ cutaneous T-cell lymphomas. Patients and Methods Forty-eight patients with CD30+ lymphoproliferative disorders or mycosis fungoides (MF) received an infusion of 1.8 mg/kg every 21 days. Results Forty-eight evaluable patients (22 women and 26 men; median age, 59.5 years) had an overall response rate of 73% (95% CI, 60% to 86%; 35 of 48 patients) and complete response rate of 35% (95% CI, 22% to 49%; 17 of 48 patients). Fifteen (54%; 95% CI, 31% to 59%) of 28 patients with MF responded, independent of CD30 expression. In patients with MF/Sézary syndrome, the overall response rate was 50% (five of 10 patients) in patients with low CD30 expression (< 10%), 58% (seven of 12 patients) in patients with medium expression (10% to 50%), and 50% (three of six patients) in patients with high expression (≥ 50%). Time to response was 12 weeks (range, 3 to 39 weeks), and duration of response was 32 weeks (range, 3 to 93 weeks). All patients with lymphomatoid papulosis (n = 9) and primary cutaneous anaplastic T-cell lymphomas (n = 2) responded; time to response was 3 weeks (range, 3 to 9 weeks), and median duration of response was 26 weeks (range, 6 to 44 weeks). Soluble baseline CD30 levels were lowest in complete responders (P = .036). Grade 1 to 2 peripheral neuropathy was observed in 65% of patients (95% CI, 52% to 79%; 31 of 48 patients), is still ongoing in 55% of patients (95% CI, 41% to 69%; 17 of 31 patients), and resolved in 45% of patients (95% CI, 31% to 59%; 14 of 31 patients), with a median time to resolution of 41.5 weeks. Grade 3 to 4 events were neutropenia (n = 5), nausea (n = 2), chest pain (n = 2), deep vein thrombosis (n = 1), transaminitis (n = 1), and dehydration (n = 1). Dose reductions to 1.2 mg/kg were instituted as a result of grade 2 neuropathy (n = 6), transaminitis (n = 1), and arthralgias and fatigue (n = 2). Conclusion Brentuximab vedotin is both active and well tolerated in cutaneous T-cell lymphoma and lymphomatoid papulosis, with an overall response rate of 73% and complete response rate of 35%. PMID:26261247

The Feasibility of Real-Time Intraoperative Performance Assessment With SIMPL (System for Improving and Measuring Procedural Learning): Early Experience From a Multi-institutional Trial.

PubMed

Bohnen, Jordan D; George, Brian C; Williams, Reed G; Schuller, Mary C; DaRosa, Debra A; Torbeck, Laura; Mullen, John T; Meyerson, Shari L; Auyang, Edward D; Chipman, Jeffrey G; Choi, Jennifer N; Choti, Michael A; Endean, Eric D; Foley, Eugene F; Mandell, Samuel P; Meier, Andreas H; Smink, Douglas S; Terhune, Kyla P; Wise, Paul E; Soper, Nathaniel J; Zwischenberger, Joseph B; Lillemoe, Keith D; Dunnington, Gary L; Fryer, Jonathan P

Intraoperative performance assessment of residents is of growing interest to trainees, faculty, and accreditors. Current approaches to collect such assessments are limited by low participation rates and long delays between procedure and evaluation. We deployed an innovative, smartphone-based tool, SIMPL (System for Improving and Measuring Procedural Learning), to make real-time intraoperative performance assessment feasible for every case in which surgical trainees participate, and hypothesized that SIMPL could be feasibly integrated into surgical training programs. Between September 1, 2015 and February 29, 2016, 15 U.S. general surgery residency programs were enrolled in an institutional review board-approved trial. SIMPL was made available after 70% of faculty and residents completed a 1-hour training session. Descriptive and univariate statistics analyzed multiple dimensions of feasibility, including training rates, volume of assessments, response rates/times, and dictation rates. The 20 most active residents and attendings were evaluated in greater detail. A total of 90% of eligible users (1267/1412) completed training. Further, 13/15 programs began using SIMPL. Totally, 6024 assessments were completed by 254 categorical general surgery residents (n = 3555 assessments) and 259 attendings (n = 2469 assessments), and 3762 unique operations were assessed. There was significant heterogeneity in participation within and between programs. Mean percentage (range) of users who completed ≥1, 5, and 20 assessments were 62% (21%-96%), 34% (5%-75%), and 10% (0%-32%) across all programs, and 96%, 75%, and 32% in the most active program. Overall, response rate was 70%, dictation rate was 24%, and mean response time was 12 hours. Assessments increased from 357 (September 2015) to 1146 (February 2016). The 20 most active residents each received mean 46 assessments by 10 attendings for 20 different procedures. SIMPL can be feasibly integrated into surgical training programs to enhance the frequency and timeliness of intraoperative performance assessment. We believe SIMPL could help facilitate a national competency-based surgical training system, although local and systemic challenges still need to be addressed. Copyright © 2016. Published by Elsevier Inc.

A Complete Pathological Response to Pembrolizumab following ex vivo Liver Resection in a Patient with Colorectal Liver Metastases.

PubMed

Baimas-George, Maria; Baker, Erin; Kamionek, Michal; Salmon, J Stuart; Sastry, Amit; Levi, David; Vrochides, Dionisios

2018-04-05

Advances in the systemic treatment of stage IV colorectal cancer with liver metastases has offered improved survival rates for patients who otherwise face a dismal prognosis. However, a pathologically complete response (PCR) to chemotherapy for colorectal liver metastases is still rare, and its significance is not fully understood. In this case report, we describe a patient who achieved PCR after neoadjuvant immunotherapy with pembrolizumab and a left hepatectomy using an ex vivo resection technique. © 2018 S. Karger AG, Basel.

Survey research with a random digit dial national mobile phone sample in Ghana: Methods and sample quality.

PubMed

L'Engle, Kelly; Sefa, Eunice; Adimazoya, Edward Akolgo; Yartey, Emmanuel; Lenzi, Rachel; Tarpo, Cindy; Heward-Mills, Nii Lante; Lew, Katherine; Ampeh, Yvonne

2018-01-01

Generating a nationally representative sample in low and middle income countries typically requires resource-intensive household level sampling with door-to-door data collection. High mobile phone penetration rates in developing countries provide new opportunities for alternative sampling and data collection methods, but there is limited information about response rates and sample biases in coverage and nonresponse using these methods. We utilized data from an interactive voice response, random-digit dial, national mobile phone survey in Ghana to calculate standardized response rates and assess representativeness of the obtained sample. The survey methodology was piloted in two rounds of data collection. The final survey included 18 demographic, media exposure, and health behavior questions. Call outcomes and response rates were calculated according to the American Association of Public Opinion Research guidelines. Sample characteristics, productivity, and costs per interview were calculated. Representativeness was assessed by comparing data to the Ghana Demographic and Health Survey and the National Population and Housing Census. The survey was fielded during a 27-day period in February-March 2017. There were 9,469 completed interviews and 3,547 partial interviews. Response, cooperation, refusal, and contact rates were 31%, 81%, 7%, and 39% respectively. Twenty-three calls were dialed to produce an eligible contact: nonresponse was substantial due to the automated calling system and dialing of many unassigned or non-working numbers. Younger, urban, better educated, and male respondents were overrepresented in the sample. The innovative mobile phone data collection methodology yielded a large sample in a relatively short period. Response rates were comparable to other surveys, although substantial coverage bias resulted from fewer women, rural, and older residents completing the mobile phone survey in comparison to household surveys. Random digit dialing of mobile phones offers promise for future data collection in Ghana and may be suitable for other developing countries.

Survey research with a random digit dial national mobile phone sample in Ghana: Methods and sample quality

PubMed Central

Sefa, Eunice; Adimazoya, Edward Akolgo; Yartey, Emmanuel; Lenzi, Rachel; Tarpo, Cindy; Heward-Mills, Nii Lante; Lew, Katherine; Ampeh, Yvonne

2018-01-01

Introduction Generating a nationally representative sample in low and middle income countries typically requires resource-intensive household level sampling with door-to-door data collection. High mobile phone penetration rates in developing countries provide new opportunities for alternative sampling and data collection methods, but there is limited information about response rates and sample biases in coverage and nonresponse using these methods. We utilized data from an interactive voice response, random-digit dial, national mobile phone survey in Ghana to calculate standardized response rates and assess representativeness of the obtained sample. Materials and methods The survey methodology was piloted in two rounds of data collection. The final survey included 18 demographic, media exposure, and health behavior questions. Call outcomes and response rates were calculated according to the American Association of Public Opinion Research guidelines. Sample characteristics, productivity, and costs per interview were calculated. Representativeness was assessed by comparing data to the Ghana Demographic and Health Survey and the National Population and Housing Census. Results The survey was fielded during a 27-day period in February-March 2017. There were 9,469 completed interviews and 3,547 partial interviews. Response, cooperation, refusal, and contact rates were 31%, 81%, 7%, and 39% respectively. Twenty-three calls were dialed to produce an eligible contact: nonresponse was substantial due to the automated calling system and dialing of many unassigned or non-working numbers. Younger, urban, better educated, and male respondents were overrepresented in the sample. Conclusions The innovative mobile phone data collection methodology yielded a large sample in a relatively short period. Response rates were comparable to other surveys, although substantial coverage bias resulted from fewer women, rural, and older residents completing the mobile phone survey in comparison to household surveys. Random digit dialing of mobile phones offers promise for future data collection in Ghana and may be suitable for other developing countries. PMID:29351349

The effect of timing of incentive payments on response rates for cohort study telephone interviews in primary care setting with cost-minimization analysis, a randomized controlled trial.

PubMed

Chin, Weng-Yee; Choi, Edmond P H; Lam, Cindy L K

2015-10-06

The effect of timing of incentive payments on the response rate of telephone surveys is unknown. This study examined whether up-front or delayed incentive payments were associated with higher response rates for participation in a telephone interview administered longitudinal cohort study amongst primary care patients with lower urinary tract symptoms, and to compare the costs between the two timing methods. This study was conducted as part of a naturalistic observation study on the health-related quality of life and health outcomes of Chinese primary care patients with lower urinary tract symptoms. The incentive payment was in the form of a supermarket gift voucher to the value of HD$50 (US$6.50) and could be used in lieu of cash at a major supermarket chain.720 subjects with lower urinary tract symptoms were randomly assigned into two groups. One group was offered an incentive of supermarket cash voucher at time of recruitment ('up-front' payment). The other group was told that the voucher would be sent to them after the complete of their 1-year follow-up telephone interview ('delayed' payment). Primary outcomes were the baseline and 1-year follow-up telephone survey response rates. There was no statistical difference in response rates at baseline (p-value = 0.938) or at the 1-year follow-up (p-value = 0.751) between groups. Cost per completed subject interviews for the up-front payment method was USD16.64, whilst cost for the delayed payment was USD 13.85. It appears the timing of incentive payments does not affect response rates for telephone interview surveys conducted on primary care patients in Hong Kong at baseline or at 1-year follow-up. Delayed incentive payments can reduce the overall cost per successful case. ClinicalTrials.gov Identifier: NCT02307929 Registered 28 August 2013.

What impact do questionnaire length and monetary incentives have on mailed health psychology survey response?

PubMed

Robb, Kathryn A; Gatting, Lauren; Wardle, Jane

2017-11-01

Response rates to health-related surveys are declining. This study tested two strategies to improve the response rate to a health psychology survey mailed through English general practices: (1) sending a shortened questionnaire and (2) offering a monetary incentive to return a completed questionnaire. Randomized controlled trial. Adults (n = 4,241) aged 45-59 years, from four General Practices in South-East England, were mailed a survey on attitudes towards bowel cancer screening. Using a 2 × 4 factorial design, participants were randomized to receive a 'short' (four A4 pages) or a 'long' (seven A4 pages) questionnaire, and one of four monetary incentives to return a completed questionnaire - (1) no monetary incentive, (2) £2.50 shop voucher, (3) £5.00 shop voucher, and (4) inclusion in a £250 shop voucher prize draw. Age, gender, and area-level deprivation were obtained from the General Practices. The overall response rate was 41% (n = 1,589). Response to the 'short' questionnaire (42%) was not significantly different from the 'long' questionnaire (40%). The £2.50 incentive (43%) significantly improved response rates in univariate analyses, and remained significant after controlling for age, gender, area-level deprivation, and questionnaire length. The £5.00 (42%) and £250 prize draw (41%) incentives had no significant impact on response rates compared to no incentive (38%). A small monetary incentive (£2.50) may slightly increase response to a mailed health psychology survey. The length of the questionnaire (four pages vs. seven pages) did not influence response. Although frequently used, entry into a prize draw did not increase response. Achieving representative samples remains a challenge for health psychology. Statement of contribution What is already known on this subject Response rates to mailed questionnaires continue to decline, threatening the representativeness of data. Prize draw incentives are frequently used but there is little evidence to support their efficacy. Research on interactions between incentives, questionnaire length, and demographics is lacking. What does this study add Contrary to previous findings, questionnaire length did not influence response rate. A £2.50 incentive increased response, while incentives of £5.00 and a £250 prize draw did not. Achieving representative samples to questionnaires remains a challenge for health psychology. © 2017 The Authors. British Journal of Health Psychology published by John Wiley & Sons Ltd on behalf of British Psychological Society.

Acute hunger modifies responses on the Three Factor Eating Questionnaire hunger and disinhibition, but not restraint, scales.

PubMed

Yeomans, Martin R; McCrickerd, Keri

2017-03-01

It is widely assumed that responses on the Three Factor Eating Questionnaire (TFEQ) represent long-term (trait) attitudes to eating behaviour. However, the questionnaire requires agreement with a number of food related statements, and it is possible that some are easier to agree with when assessed hungry than sated. To test this potential state-dependency, participants completed a 100 mm visual analogue scale rating of their current hunger at the time they completed the TFEQ. Data were collected from two cohorts: Cohort 1 (507 women and 119 men) completed both measures on paper, while the hunger rating was computerised in Cohort 2 (179 women). Regression analysis revealed significant effects of rated hunger on scores on the hunger (TFEQ-H) and disinhibition (TFEQ-D) but not restraint (TFEQ-R) subscales, with higher TFEQ-H and TFEQ-D scores when participants were more hungry. In addition, 61 women and two men from Cohort 1 completed the measures on two separate occasions. Here, scores on TFEQ-H were higher on days when these participants were hungrier, but no differences in TFEQ-D or TFEQ-R were found. Overall these data suggest TFEQ-H could be interpreted as an indirect measure of current hunger, that scores on TFEQ-D are partly moderated by hunger but TFEQ-R is a more trait-like measure of restraint. Copyright © 2016 Elsevier Ltd. All rights reserved.

A prospective randomized study of Chop versus Chop plus alpha-2B interferon in patients with intermediate and high grade non-Hodgkin's lymphoma: the International Oncology Study Group NHL1 Study .

PubMed

Giles, F J; Shan, J; Advani, S H; Akan, H; Aydogdu, I; Aziz, Z; Azim, H A; Bapsy, P P; Buyukkececi, F; Chaimongkol, B; Chen, P M; Cheong, S K; Ferhanoglu, B; Hamza, R; Khalid, H M; Intragumtornchai, T; Kim, S W; Kim, S Y; Koc, H; Kumar, L; Kumar, R; Lei, K I; Lekhakula, A; Muthalib, A; Patel, M; Poovalingam, V P; Prayoonwiwat, W; Rana, F; Reksodiputro, A H; Ruff, P; Sagar, T G; Schwarer, A P; Song, H S; Suh, C W; Suharti, C; Supindiman, I; Tee, G Y; Thamprasit, T; Villalon, A H; Wickham, N R; Wong, J E; Yalcin, A; Jootar, S

2000-12-01

The addition of a brief alpha interferon regimen to each CHOP induction cycle, plus one year of alpha interferon thrice weekly maintenance therapy, has no early effect on response rates or survival in patients with Intermediate or High grade cell NHL. The CHOP (Cyclophosphamide, Adriamycin. Vincristine, Prednisone) regimen is the most widely used first-line therapy for patients with Intermediate or High Grade (IG/HG) non-Hodgkin's lymphoma (NHL). Alpha 2b interferon (INF) enhances response rates and improves survival in low-grade NHL. The International Oncology Study Group (IOSG) conducted a prospective randomized study comparing CHOP alone or combined with INF in patients with IG/HG-NHL. The primary study aim was to compare the objective response rates in these patient cohorts. Patients with a confirmed diagnosis of measurable NHL of International Working Formulation (IWF) groups D to H histology were randomized to receive CHOP alone or CHOP with 5Mu INF s.c. for 5 days on days 22 to 26 of each 28 day cycle with INF 5 million units (Mu) given three times per week subcutaneously for 52 weeks in those patients who responded to CHOP plus INF. The overall response rates were equivalent in both groups: CHOP alone (214 patients) 81% (complete 55%, partial 26%); CHOP plus INF (221 patients) 80% (complete 54%, partial 26%). At 36 months, the actuarial survival rate was equivalent in both groups. There is no apparent early advantage in terms of response or survival conferred by adding the study INF regimen to CHOP therapy for patients with IG/HG-NHL.

Heterogeneity of response to antipsychotics from multiple disorders in the schizophrenia spectrum.

PubMed

Garver, D L; Holcomb, J A; Christensen, J D

2000-12-01

Antipsychotic response after the initiation of neuroleptic treatment shows wide variation in schizophrenic patient populations. In this overview, the authors suggest that the variance in antipsychotic drug response within schizophrenia can be reduced by resolving the schizophrenias into several discrete "endophenotypes," each with different etiologic underpinnings. Studies relating differences in the relative speed or completeness of antipsychotic response to differences in distribution of 2 biological markers with possible etiologic significance are reviewed. Such studies had assessed recently hospitalized, neuroleptic-free patients undergoing exacerbation of nonaffective psychotic disorders. Prior to initiation of neuroleptic, the cohort of patients had been assessed for the quantity of the dopamine metabolite homovanillic acid in plasma (pHVA) and had undergone the first of 2 magnetic resonance imaging (MRI) studies for analyses of ventricle volumes. A second MRI was subsequently performed during a period of (partial) remission to determine within-patient stability of ventricular volumes. These selected studies assessed the distribution of pHVA and distribution of rates of ventricular change, with non-normal distributions resolved by K-means clustering. The speed and completeness of neuroleptic-induced antipsychotic response were related to 3 clusters of patients delineated by modal distributions of pHVA and of apparent rates of ventricular change. At least 3 unique "endophenotypes" of the "group of the schizophrenias" can be defined with respect to speed and completeness of antipsychotic response. Each endophenotype appears to show at least one unique biological feature that differentiates it from a normal comparison group. A rapidly responsive psychosis was associated with excessive production of dopamine, as identifiable by elevation of pHVA and a "good-prognosis" course. A delayed-response psychosis had low-to-normal pHVA, clinically demonstrated persistent negative symptoms, and was associated with an excessive rate of change in ventricle volume between exacerbations of psychosis and (partial) remissions. Finally, a nonresponsive psychosis could be characterized as having both low-to-normal pHVA and rate of change of ventricle volumes similar to that of controls. Additional studies revealed that each of the endophenotypes had high rates of the psychoses in family members. The good-prognosis course of the rapidly responsive group of studied patients was also found in their family members who had psychotic disorders. Similarly, the prominent negative symptoms of the delayed-response probands were reflected as a prominent trait in their family members also afflicted with psychosis. The endophenotypes tended to "breed true" in terms of prognosis and negative symptoms. Major differences in antipsychotic response patterns appear to be associated with patient and family characteristics that may be related to differences in the etiology and consequent pathophysiology of illness.

An online survey of chiropractors' opinions of continuing education

PubMed Central

Stuber, Kent J; Grod, Jaroslaw P; Smith, Dean L; Powers, Paul

2005-01-01

Background Continuing Education (CE) for chiropractors is mandatory for licensure in most North American jurisdictions. Numerous chiropractic colleges have begun collaborating with universities to offer master's degree programs. Distance education master's degree programs may be desirable to allow full-time practicing doctors to further their post-graduate education. The present survey sought to answer three questions. First, what is the level of satisfaction of chiropractors with their continuing education? Second, what is the level of interest of chiropractors in online master's degree programs? Lastly, what is the response rate of chiropractors to an online survey? Methods An online survey consisting of 22 multiple choice questions was e-mailed to 1000 chiropractors randomly selected from the mailing list of an online chiropractic newsletter. Upon completion of the questionnaire, participants' answers were saved on a secure site. Data analysis included evaluation of the demographic characteristics of the respondents, their opinions of and patterns of taking CE including online education, preferred learning formats, and their interest in proposed online master's degree programs. A survey response rate was determined. Results Nearly 86% of respondents felt their previously completed CE courses were either somewhat or extremely satisfactory. Over ninety percent of respondents who had completed online or distance CE coursesfound them to be somewhat or extremelysatisfactory. Almost half the respondents indicated that they most preferred online distance learning, while 34.08% most preferred face-to-face interaction. Fifty-three percent of respondents indicated an interest in starting a master's degree program; however 70.46% of respondents were interested in an online master's degree program that would offer CE credit. A response rate of 35.8% was obtained. Conclusion Satisfaction among chiropractors with CE programs is high. The notion of completing a part-time online master's degree (or online combined with face-to-face interaction) appears to be popular among respondents, with a M.Sc. in Chiropractic Sciences being the most popular of those mentioned. Online surveys are a viable method of obtaining opinion in a cost and time efficient manner; there are some sources of bias involved in this type of research, and numerous steps need to be taken to obtain a suitable response rate. PMID:16242035

Revising a College 101 Course for Sustained Impact: Early Outcomes

ERIC Educational Resources Information Center

Karp, Melinda Mechur; Raufman, Julia; Efthimiou, Chris; Ritze, Nancy

2017-01-01

In response to strikingly low completion rates in public 2-year colleges, including for students who are well-prepared academically, most community colleges across the country offer student success courses as one approach to improving outcomes for students. Some colleges have begun to revise these courses in response to research indicating that…

Phase II study of neoadjuvant gemcitabine, pegylated liposomal doxorubicin, and docetaxel in locally advanced breast cancer.

PubMed

Artioli, Grazia; Grazia, Artioli; Mocellin, Simone; Simone, Mocellin; Borgato, Lucia; Lucia, Borgato; Cappetta, Alessandro; Alessandro, Cappetta; Bozza, Fernando; Fernando, Bozza; Zavagno, Giorgio; Giorgio, Zavagno; Zovato, Stefania; Stefania, Zovato; Marchet, Alberto; Alberto, Marchet; Pastorelli, Davide; Davide, Pastorelli

2010-09-01

This was a phase II study to assess the activity of a novel neoadjuvant regimen in locally-advanced breast cancer. Fifty patients with histological confirmation of locally advanced breast cancer received treatment with gemcitabine 1000 mg/m(2) (day 1) followed by gemcitabine 800 mg/m(2) plus docetaxel 75 mg/m(2) plus pegylated liposomal doxorubicin (PLD) 30 mg/m(2) (day 8) every 3 weeks for at least 4 cycles, plus a final 2 additional cycles. Tumour size was T1 (n=2), T2 (n=32), T3 (n=14), T4 (n=2). All 50 patients underwent surgery. Clinical complete, partial and no response were observed in 13 (26%), 24 (48%) and 11 (22%) patients, respectively (overall response rate: 74%). The number of chemotherapy cycles was found to be an independent predictor of a pathologic complete response. The combination of gemcitabine-docetaxel-PLD can yield high tumour response rates in patients with locally-advanced breast cancer who undergo a full treatment of 6 cycles.

The role of optoelectronic feedback on Franz-Keldysh voltage modulation of transistor lasers

NASA Astrophysics Data System (ADS)

Chang, Chi-Hsiang; Chang, Shu-Wei; Wu, Chao-Hsin

2016-03-01

Possessing both the high-speed characteristics of heterojunction bipolar transistors (HBTs) and enhanced radiative recombination of quantum wells (QWs), the light-emitting transistor (LET) which operates in the regime of spontaneous emissions has achieved up to 4.3 GHz modulation bandwidth. A 40 Gbit/s transmission rate can be even achieved using transistor laser (TL). The transistor laser provides not only the current modulation but also direct voltage-controlled modulation scheme of optical signals via Franz-Keldysh (FK) photon-assisted tunneling effect. In this work, the effect of FK absorption on the voltage modulation of TLs is investigated. In order to analyze the dynamics and optical responses of voltage modulation in TLs, the conventional rate equations relevant to diode lasers (DLs) are first modified to include the FK effect intuitively. The theoretical results of direct-current (DC) and small-signal alternating-current (AC) characteristics of optical responses are both investigated. While the DC characteristics look physical, the intrinsic optical response of TLs under the FK voltage modulation shows an AC enhancement with a 20 dB peak, which however is not observed in experiment. A complete model composed of the intrinsic optical transfer function and an electrical transfer function fed back by optical responses is proposed to explain the behaviors of voltage modulation in TLs. The abnormal AC peak disappears through this optoelectronic feedback. With the electrical response along with FK-included photon-carrier rate equations taken into account, the complete voltage-controlled optical modulation response of TLs is demonstrated.

Unconditional and conditional incentives differentially improved general practitioners' participation in an online survey: randomized controlled trial.

PubMed

Young, Jane M; O'Halloran, Anna; McAulay, Claire; Pirotta, Marie; Forsdike, Kirsty; Stacey, Ingrid; Currow, David

2015-06-01

To compare the impact of unconditional and conditional financial incentives on response rates among Australian general practitioners invited by mail to participate in an online survey about cancer care and to investigate possible differential response bias between incentive groups. Australian general practitioners were randomly allocated to unconditional incentive (book voucher mailed with letter of invitation), conditional incentive (book voucher mailed on completion of the online survey), or control (no incentive). Nonresponders were asked to complete a small subset of questions from the online survey. Among 3,334 eligible general practitioners, significantly higher response rates were achieved in the unconditional group (167 of 1,101, 15%) compared with the conditional group (118 of 1,111, 11%) (P = 0.0014), and both were significantly higher than the control group (74 of 1,122, 7%; both P < 0.001). Although more positive opinions about cancer care were expressed by online responders compared with nonresponders, there was no evidence that the magnitude of difference varied by the incentive group. The incremental cost for each additional 1% increase above the control group response rate was substantially higher for the unconditional incentive group compared with the conditional incentive group. Both unconditional and conditional financial incentives significantly increased response with no evidence of differential response bias. Although unconditional incentives had the largest effect, the conditional approach was more cost-effective. Copyright © 2015 Elsevier Inc. All rights reserved.

The Impact of Silhouette Randomization on the Results of Figure Rating Scales

ERIC Educational Resources Information Center

Duncan, Michael J.; Dodd, Lorna J.; Al-Nakeeb, Yahya

2005-01-01

This study was designed to examine the impact of silhouette randomization on the responses to rating scales developed to rate the perceived current and ideal body shape, as well as body dissatisfaction. Seventy students (30 men and 40 women), ages 18 to 43 (M [plus or minus] SD = 22.1 [plus or minus] 5.7) years, completed the Stunkard, Sorensen,…

Gibbons-Hawking radiation of gravitons in the Poincaré and static patches of de Sitter spacetime

NASA Astrophysics Data System (ADS)

Bernar, Rafael P.; Crispino, Luís C. B.; Higuchi, Atsushi

2018-04-01

We discuss the quantization of linearized gravity in the background de Sitter spacetime using a gauge-invariant formalism to write the perturbed gravitational field in the static patch. This field is quantized after fixing the gauge completely. The response rate of this field to monochromatic multipole sources is then computed in the thermal equilibrium state with the well-known Gibbons-Hawking temperature. We compare this response rate with the one obtained in the Bunch-Davies-like vacuum state defined in the Poincaré patch. These response rates are found to be the same as expected. This agreement serves as a verification of the infrared finite graviton two-point function in the static patch of de Sitter spacetime found previously.

Evaluation of Mechanisms to Improve Performance of Mobile Phone Surveys in Low- and Middle-Income Countries: Research Protocol.

PubMed

Gibson, Dustin G; Pariyo, George William; Wosu, Adaeze C; Greenleaf, Abigail R; Ali, Joseph; Ahmed, Saifuddin; Labrique, Alain B; Islam, Khaleda; Masanja, Honorati; Rutebemberwa, Elizeus; Hyder, Adnan A

2017-05-05

Mobile phone ownership and access have increased rapidly across low- and middle-income countries (LMICs) within the last decade. Concomitantly, LMICs are experiencing demographic and epidemiologic transitions, where non-communicable diseases (NCDs) are increasingly becoming leading causes of morbidity and mortality. Mobile phone surveys could aid data collection for prevention and control of these NCDs but limited evidence of their feasibility exists. The objective of this paper is to describe a series of sub-studies aimed at optimizing the delivery of interactive voice response (IVR) and computer-assisted telephone interviews (CATI) for NCD risk factor data collection in LMICs. These sub-studies are designed to assess the effect of factors such as airtime incentive timing, amount, and structure, survey introduction characteristics, different sampling frames, and survey modality on key survey metrics, such as survey response, completion, and attrition rates. In a series of sub-studies, participants will be randomly assigned to receive different airtime incentive amounts (eg, 10 minutes of airtime versus 20 minutes of airtime), different incentive delivery timings (airtime delivered before survey begins versus delivery upon completion of survey), different survey introductions (informational versus motivational), different narrative voices (male versus female), and different sampling frames (random digit dialing versus mobile network operator-provided numbers) to examine which study arms will yield the highest response and completion rates. Furthermore, response and completion rates and the inter-modal reliability of the IVR and CATI delivery methods will be compared. Research activities are expected to be completed in Bangladesh, Tanzania, and Uganda in 2017. This is one of the first studies to examine the feasibility of using IVR and CATI for systematic collection of NCD risk factor information in LMICs. Our findings will inform the future design and implementation of mobile phone surveys in LMICs. ©Dustin G Gibson, George William Pariyo, Adaeze C Wosu, Abigail R Greenleaf, Joseph Ali, Saifuddin Ahmed, Alain B Labrique, Khaleda Islam, Honorati Masanja, Elizeus Rutebemberwa, Adnan A Hyder. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 05.05.2017.

Rates, Delays, and Completeness of General Practitioners’ Responses to a Postal Versus Web-Based Survey: A Randomized Trial

PubMed Central

Maisonneuve, Hubert; Cerutti, Bernard; Fournier, Jean Pascal; Senn, Nicolas; Haller, Dagmar M

2017-01-01

Background Web-based surveys have become a new and popular method for collecting data, but only a few studies have directly compared postal and Web-based surveys among physicians, and none to our knowledge among general practitioners (GPs). Objective Our aim is to compare two modes of survey delivery (postal and Web-based) in terms of participation rates, response times, and completeness of questionnaires in a study assessing GPs’ preventive practices. Methods This randomized study was conducted in Western Switzerland (Geneva and Vaud) and in France (Alsace and Pays de la Loire) in 2015. A random selection of community-based GPs (1000 GPs in Switzerland and 2400 GPs in France) were randomly allocated to receive a questionnaire about preventive care activities either by post (n=700 in Switzerland, n=400 in France) or by email (n=300 in Switzerland, n=2000 in France). Reminder messages were sent once in the postal group and twice in the Web-based group. Any GPs practicing only complementary and alternative medicine were excluded from the study. Results Among the 3400 contacted GPs, 764 (22.47%, 95% CI 21.07%-23.87%) returned the questionnaire. Compared to the postal group, the participation rate in the Web-based group was more than four times lower (246/2300, 10.70% vs 518/1100, 47.09%, P<.001), but median response time was much shorter (1 day vs 1-3 weeks, P<.001) and the number of GPs having fully completed the questionnaire was almost twice as high (157/246, 63.8% vs 179/518, 34.6%, P<.001). Conclusions Web-based surveys offer many advantages such as reduced response time, higher completeness of data, and large cost savings, but our findings suggest that postal surveys can be still considered for GP research. The use of mixed-mode approaches is probably a good strategy to increase GPs’ participation in surveys while reducing costs. PMID:28330830

Computer-automated dementia screening using a touch-tone telephone.

PubMed

Mundt, J C; Ferber, K L; Rizzo, M; Greist, J H

2001-11-12

This study investigated the sensitivity and specificity of a computer-automated telephone system to evaluate cognitive impairment in elderly callers to identify signs of early dementia. The Clinical Dementia Rating Scale was used to assess 155 subjects aged 56 to 93 years (n = 74, 27, 42, and 12, with a Clinical Dementia Rating Scale score of 0, 0.5, 1, and 2, respectively). These subjects performed a battery of tests administered by an interactive voice response system using standard Touch-Tone telephones. Seventy-four collateral informants also completed an interactive voice response version of the Symptoms of Dementia Screener. Sixteen cognitively impaired subjects were unable to complete the telephone call. Performances on 6 of 8 tasks were significantly influenced by Clinical Dementia Rating Scale status. The mean (SD) call length was 12 minutes 27 seconds (2 minutes 32 seconds). A subsample (n = 116) was analyzed using machine-learning methods, producing a scoring algorithm that combined performances across 4 tasks. Results indicated a potential sensitivity of 82.0% and specificity of 85.5%. The scoring model generalized to a validation subsample (n = 39), producing 85.0% sensitivity and 78.9% specificity. The kappa agreement between predicted and actual group membership was 0.64 (P<.001). Of the 16 subjects unable to complete the call, 11 provided sufficient information to permit us to classify them as impaired. Standard scoring of the interactive voice response-administered Symptoms of Dementia Screener (completed by informants) produced a screening sensitivity of 63.5% and 100% specificity. A lower criterion found a 90.4% sensitivity, without lowering specificity. Computer-automated telephone screening for early dementia using either informant or direct assessment is feasible. Such systems could provide wide-scale, cost-effective screening, education, and referral services to patients and caregivers.

The Patient Educator Presentation in Dental Education: Reinforcing the Importance of Learning About Rare Conditions.

PubMed

Edwards, Paul C; Graham, Jasmine; Oling, Rebecca; Frantz, Kate E

2016-05-01

The aim of this study was to determine whether a patient educator presentation (PEP) on pemphigus vulgaris would increase second-year dental students' awareness of the importance of learning about rare conditions and improve their retention of rare disease knowledge. The study involved students' subjective assessments of a PEP experience at two U.S. dental schools. In this mixed methods study, cross-sectional data were obtained by surveys and in-depth interviews. Questions focused on students' assessment of the messages acquired from the PEP and its likely impact on their future clinical care. At University 1, students completed paper surveys with open-ended questions and participated in a focus group. At University 2, students completed an online survey consisting of rating scale and open-ended questions. Responses to open-ended questions were categorized into themes. At University 1, 79 students (out of a possible 102; response rate 77.5%) completed the survey, and an additional ten students participated in a focus group. At University 2, 30 students (out of a possible 104; response rate 28.8%) completed the survey. At Universities 1 and 2, 88% and 100%, respectively, of respondents stated the PEP would influence their future clinical decision making. The vast majority of respondents (94% and 100% at University 1 and University 2, respectively) were of the opinion that the personal testimonial from a patient would help them recall information about pemphigus vulgaris in five years' time. Respondents from both universities commented that the PEP emphasized the importance of not dismissing a patient's concerns. These results suggest that a presentation by a patient with a rare condition can be an effective educational tool for preclinical dental students.

Effects of various methodologic strategies: survey response rates among Canadian physicians and physicians-in-training.

PubMed

Grava-Gubins, Inese; Scott, Sarah

2008-10-01

To increase the overall 2007 response rate of the National Physician Survey (NPS) from the survey's 2004 rate of response with the implementation of various methodologic strategies. Physicians were stratified to receive either a long version (12 pages) or a short version (6 pages) of the survey (38% and 62%, respectively). Mixed modes of contact were used-58% were contacted by e-mail and 42% by regular mail-with multiple modes of contact attempted for nonrespondents. The self-administered, confidential surveys were distributed in either English or French. Medical residents and students received e-mail surveys only and were offered a substantial monetary lottery incentive for completing their surveys. A professional communications firm assisted in marketing the survey and delivered advance notification of its impending distribution. Canada. A total of 62 441 practising physicians, 2627 second-year medical residents, and 9162 medical students in Canada. Of the practising physicians group, 60 811 participants were eligible and 19 239 replied, for an overall 2007 study response rate of 31.64% (compared with 35.85% in 2004). No difference in rate of response was found between the longer and shorter versions of the survey. If contacted by regular mail, the response rate was 34.1%; the e-mail group had a response rate of 29.9%. Medical student and resident response rates were 30.8% and 27.9%, respectively (compared with 31.2% and 35.6% in 2004). Despite shortening the questionnaires, contacting more physicians by e-mail, and enhancing marketing and follow-up, the 2007 NPS response rate for practising physicians did not surpass the 2004 NPS response rate. Offering a monetary lottery incentive to medical residents and students was also unsuccessful in increasing their response rates. The role of surveys in gathering information from physicians and physicians-in-training remains problematic. Researchers need to investigate alternative strategies for achieving higher rates of response.

Phase II study of neoadjuvant treatment with doxorubicin, docetaxel, and capecitabine (ATX) in locally advanced or inflammatory breast cancer.

PubMed

Manga, Gumersindo Pérez; Shahi, Parham Khosravi; Ureña, Miguel Méndez; Pereira, Rosa Quiben; Plaza, María Isabel Palomero; Peron, Yann Izarzugaza; Val, Ricardo González Del; Carrión, Joaquín Belón; Cañón, Esperanza Pérez; Alfonso, Pilar García

2010-07-01

Pathologic complete response (pCR) after preoperative systemic chemotherapy (PSCh) is associated with better outcome in locally advanced breast cancer (LABC). PSCh included: doxorubicin (A) 50 mg/m(2) i.v. on day 1; docetaxel (T) 30 mg/m(2) i.v. on days 1, 8 and 15; and capecitabine (X) 1,500 mg/m(2)/day p.o. on days 1-14, in a 4-week course repeated for up to four cycles (ATX), followed by surgery. The primary end point of this study was to evaluate the pCR rate. Secondary endpoints included clinical response rate, disease-free survival (DFS), overall survival (OS), and the toxicity profile. A total of 60 patients were included in the analysis. Median age was 49 years, and 63.3% of patients were hormone receptor positive. The median number of cycles of PSCh was four (95% CI: 3-4). Five patients (8.3%) achieved pCR in both breast and nodes, and 16.7% reached pCR only in nodes. The clinical response rate was 77% (27% complete response), but only 18% of the patients underwent conservative surgery. With a median follow-up of 20 months, 3-year DFS and OS were 76 and 90%, respectively. Grade III/IV toxicity included neutropenia (74%), febrile neutropenia (9%), mucositis (12%), and diarrhea (12%). ATX every 28 days for four cycles is associated with a modest activity (low pCR rate) in the neoadjuvant setting of LABC.

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

Huang, Eugene H.; Strom, Eric A.; Valero, Vicente

Purpose: To evaluate the locoregional efficacy of multimodality treatment for breast cancer patients who present with ipsilateral supraclavicular (SCV) disease without systemic metastases. Methods: We retrospectively reviewed the data from 71 patients with ipsilateral SCV involvement at presentation. SCV involvement in 16 patients (23%) was diagnosed by ultrasound examination only, without palpable disease. All patients were treated with curative intent using neoadjuvant chemotherapy, mastectomy or breast-conserving surgery (BCT), and radiotherapy. Results: The 5-year SCV control, locoregional control (LRC), disease-free survival, and overall survival rate was 90%, 77%, 30%, and 47%, respectively. Patients with persistent SCV disease after neoadjuvant chemotherapy bymore » physical examination had a lower rate of LRC (64% vs. 86%, p = 0.026), as did those with persistent SCV disease by ultrasound examination (66% vs. 96%, p = 0.007). Of those with a complete response of SCV disease by physical examination after neoadjuvant chemotherapy, those with persistently abnormal ultrasound findings had significantly worse disease-free survival (0% vs. 55%, p = 0.03). BCT was not associated with lower rates of LRC (82% for BCT vs. 76% for mastectomy, p = 0.80). Conclusion: Radiotherapy achieved excellent LRC after surgery for patients with ipsilateral SCV metastases who achieved a complete response of the SCV disease after neoadjuvant chemotherapy. For patients who achieved a complete response of the SCV disease by physical examination, ultrasonography of the SCV fossa may help assess the risk of disease recurrence. SCV involvement should not be considered a contraindication for BCT.« less

Competitive active video games: Physiological and psychological responses in children and adolescents.

PubMed

Lisón, Juan F; Cebolla, Ausias; Guixeres, Jaime; Álvarez-Pitti, Julio; Escobar, Patricia; Bruñó, Alejandro; Lurbe, Empar; Alcañiz, Mariano; Baños, Rosa

2015-10-01

Recent strategies to reduce sedentary behaviour in children include replacing sedentary screen time for active video games. Active video game studies have focused principally on the metabolic consumption of a single player, with physiological and psychological responses of opponent-based multiplayer games to be further evaluated. To determine whether adding a competitive component to playing active video games impacts physiological and psychological responses in players. Sixty-two healthy Caucasian children and adolescents, nine to 14 years years of age, completed three conditions (8 min each) in random order: treadmill walking, and single and opponent-based Kinect active video games. Affect, arousal, rate of perceived exertion, heart rate and percentage of heart rate reserve were measured for each participant and condition. Kinect conditions revealed significantly higher heart rate, percentage of heart rate reserve, rate of perceived exertion and arousal when compared with treadmill walking (P<0.001). Opponent-based condition revealed lower values for the rate of perceived exertion (P=0.02) and higher affect (P=0.022) when compared with single play. Competitive active video games improved children's psychological responses (affect and rate of perceived exertion) compared with single play, providing a solution that may contribute toward improved adherence to physical activity.

Sustained-release bupropion versus naltrexone in the treatment of pathological gambling: a preliminary blind-rater study.

PubMed

Dannon, Pinhas N; Lowengrub, Katherine; Musin, Ernest; Gonopolski, Yehudit; Kotler, Moshe

2005-12-01

Pathological gambling (PG) is a relatively common and highly disabling impulse control disorder. A range of psychotherapeutic agents, including selective serotonin reuptake inhibitors, mood stabilizers, and opioid antagonists, has been shown to be effective in the treatment of PG. The use of selective serotonin reuptake inhibitors and opioid antagonists for PG is consistent with the observation that PG shares features of both the obsessive-compulsive spectrum disorders and addictive disorders. The aim of the study is to compare the effectiveness of sustained-release bupropion versus naltrexone in the treatment of PG. Thirty-six male pathological gamblers were enrolled in our study. A comprehensive psychiatric diagnostic evaluation was performed at baseline on all patients, and patients were screened for symptoms of gambling, depression, and anxiety using the South Oaks Gambling Screen, the Hamilton Depression Rating Scale, the Hamilton Anxiety Rating Scale, and the Clinical Global Impression-Severity Scale. In addition, the patients completed self-report questionnaires about their demographic status. Patients were randomized in 2 groups and received either naltrexone (n = 19) or sustained-release bupropion (n = 17) for 12 weeks in a parallel fashion. Treatment response was monitored using the Clinical Global Impression-Improvement Scale which was performed at weeks 2, 4, 8, and 12. Patients were also assessed for the presence of gambling behavior via an unstructured interview, which was also performed at weeks 2, 4, 6, 8, and 12. Raters were blind to the study treatment. The majority of patients responded well to the drug treatment. Twelve of 17 patients in the sustained-release bupropion group completed the 12-week study, and 13 of 19 naltrexone patients completed the study. Nine (75%) of the 12 completers were rated as full responders in the sustained-release bupropion group versus 10 (76%) of 12 in the naltrexone group. Three (25%) of 12 completers in the bupropion group were rated as partial responders. In the naltrexone group, 3 (23%) of 13 completers were rated as partial responders. Full response was defined as the absence of gambling for a 2-week duration together with improvement on the Clinical Global Impression-Improvement Scale. Partial response was defined as a decrease in the frequency of gambling behavior and a decrease in the amount of money spent on gambling. This preliminary study shows that sustained-release bupropion may be effective as naltrexone in the treatment of PG. Further studies are needed to confirm our findings.

Enhancing the Benefits of Written Emotional Disclosure through Response Training

PubMed Central

Konig, Andrea; Eonta, Alison; Dyal, Stephanie R.; Vrana, Scott R.

2014-01-01

Writing about a personal stressful event has been found to have psychological and physical health benefits, especially when physiological response increases during writing. Response training was developed to amplify appropriate physiological reactivity in imagery exposure. The present study examined whether response training enhances the benefits of written emotional disclosure. Participants were assigned to either a written emotional disclosure condition (n = 113) or a neutral writing condition (n = 133). Participants in each condition wrote for 20 minutes on three occasions and received response training (n = 79), stimulus training (n = 84) or no training (n = 83). Heart rate and skin conductance were recorded throughout a 10-minute baseline, 20-minute writing, and a 10-minute recovery period. Self-reported emotion was assessed in each session. One month after completing the sessions, participants completed follow-up assessments of psychological and physical health outcomes. Emotional disclosure elicited greater physiological reactivity and self-reported emotion than neutral writing. Response training amplified physiological reactivity to emotional disclosure. Greater heart rate during emotional disclosure was associated with the greatest reductions in event-related distress, depression, and physical illness symptoms at follow-up, especially among response trained participants. Results support an exposure explanation of emotional disclosure effects and are the first to demonstrate that response training facilitates emotional processing and may be a beneficial adjunct to written emotional disclosure. PMID:24680230

Enhancing the benefits of written emotional disclosure through response training.

PubMed

Konig, Andrea; Eonta, Alison; Dyal, Stephanie R; Vrana, Scott R

2014-05-01

Writing about a personal stressful event has been found to have psychological and physical health benefits, especially when physiological response increases during writing. Response training was developed to amplify appropriate physiological reactivity in imagery exposure. The present study examined whether response training enhances the benefits of written emotional disclosure. Participants were assigned to either a written emotional disclosure condition (n=113) or a neutral writing condition (n=133). Participants in each condition wrote for 20 minutes on 3 occasions and received response training (n=79), stimulus training (n=84) or no training (n=83). Heart rate and skin conductance were recorded throughout a 10-minute baseline, 20-minute writing, and a 10-minute recovery period. Self-reported emotion was assessed in each session. One month after completing the sessions, participants completed follow-up assessments of psychological and physical health outcomes. Emotional disclosure elicited greater physiological reactivity and self-reported emotion than neutral writing. Response training amplified physiological reactivity to emotional disclosure. Greater heart rate during emotional disclosure was associated with the greatest reductions in event-related distress, depression, and physical illness symptoms at follow-up, especially among response trained participants. Results support an exposure explanation of emotional disclosure effects and are the first to demonstrate that response training facilitates emotional processing and may be a beneficial adjunct to written emotional disclosure. Copyright © 2014. Published by Elsevier Ltd.

Adaptive Randomization of Neratinib in Early Breast Cancer.

PubMed

Park, John W; Liu, Minetta C; Yee, Douglas; Yau, Christina; van 't Veer, Laura J; Symmans, W Fraser; Paoloni, Melissa; Perlmutter, Jane; Hylton, Nola M; Hogarth, Michael; DeMichele, Angela; Buxton, Meredith B; Chien, A Jo; Wallace, Anne M; Boughey, Judy C; Haddad, Tufia C; Chui, Stephen Y; Kemmer, Kathleen A; Kaplan, Henry G; Isaacs, Claudine; Nanda, Rita; Tripathy, Debasish; Albain, Kathy S; Edmiston, Kirsten K; Elias, Anthony D; Northfelt, Donald W; Pusztai, Lajos; Moulder, Stacy L; Lang, Julie E; Viscusi, Rebecca K; Euhus, David M; Haley, Barbara B; Khan, Qamar J; Wood, William C; Melisko, Michelle; Schwab, Richard; Helsten, Teresa; Lyandres, Julia; Davis, Sarah E; Hirst, Gillian L; Sanil, Ashish; Esserman, Laura J; Berry, Donald A

2016-07-07

The heterogeneity of breast cancer makes identifying effective therapies challenging. The I-SPY 2 trial, a multicenter, adaptive phase 2 trial of neoadjuvant therapy for high-risk clinical stage II or III breast cancer, evaluated multiple new agents added to standard chemotherapy to assess the effects on rates of pathological complete response (i.e., absence of residual cancer in the breast or lymph nodes at the time of surgery). We used adaptive randomization to compare standard neoadjuvant chemotherapy plus the tyrosine kinase inhibitor neratinib with control. Eligible women were categorized according to eight biomarker subtypes on the basis of human epidermal growth factor receptor 2 (HER2) status, hormone-receptor status, and risk according to a 70-gene profile. Neratinib was evaluated against control with regard to 10 biomarker signatures (prospectively defined combinations of subtypes). The primary end point was pathological complete response. Volume changes on serial magnetic resonance imaging were used to assess the likelihood of such a response in each patient. Adaptive assignment to experimental groups within each disease subtype was based on Bayesian probabilities of the superiority of the treatment over control. Enrollment in the experimental group was stopped when the 85% Bayesian predictive probability of success in a confirmatory phase 3 trial of neoadjuvant therapy reached a prespecified threshold for any biomarker signature ("graduation"). Enrollment was stopped for futility if the probability fell to below 10% for every biomarker signature. Neratinib reached the prespecified efficacy threshold with regard to the HER2-positive, hormone-receptor-negative signature. Among patients with HER2-positive, hormone-receptor-negative cancer, the mean estimated rate of pathological complete response was 56% (95% Bayesian probability interval [PI], 37 to 73%) among 115 patients in the neratinib group, as compared with 33% among 78 controls (95% PI, 11 to 54%). The final predictive probability of success in phase 3 testing was 79%. Neratinib added to standard therapy was highly likely to result in higher rates of pathological complete response than standard chemotherapy with trastuzumab among patients with HER2-positive, hormone-receptor-negative breast cancer. (Funded by QuantumLeap Healthcare Collaborative and others; I-SPY 2 TRIAL ClinicalTrials.gov number, NCT01042379.).

Effects of diabetes mellitus on the clinical presentation and treatment response in tuberculosis.

PubMed

Leung, Chi C; Yew, Wing W; Mok, Thomas Y W; Lau, Kam S; Wong, Chi F; Chau, Chi H; Chan, Chi K; Chang, Kwok C; Tam, Greta; Tam, Cheuk M

2017-08-01

With the colliding global epidemics of diabetes mellitus (DM) and tuberculosis (TB), we studied the effects of DM on the presentation of TB and its response to treatment. Consecutive TB patients from 2006 to 2010 in a territory-wide treatment programme offering 9-month extended treatment for TB patients with DM were examined and followed up prospectively to assess their treatment response. Successful treatment completers were tracked through the TB registry and death registry for relapse, death or till 31 December 2014, whichever was the earliest. DM was independently associated with more chest symptoms (adjusted OR (AOR): 1.13) and systemic symptoms (AOR: 1.30) but less with other site-specific symptoms (AOR: 0.58) at TB presentation. There was more frequent pulmonary involvement (AOR: 1.69), with more extensive lung lesion (AOR: 1.25), lung cavity (AOR: 2.00) and positive sputum smear (AOR: 1.83) and culture (AOR: 1.38), but no difference in the proportion of retreatment cases or isoniazid and/or rifampicin resistance. After treatment initiation, there was higher overall incidence (AOR: 1.38) of adverse effects (mainly gastrointestinal symptoms, renal impairment and peripheral neuropathy but less fever and skin hypersensitivity reactions), more smear non-conversion (AOR: 1.59) and culture non-conversion (AOR: 1.40) at 2 months, and lower combined cure/treatment completion rate at 12 months (AOR: 0.79), but no difference in the relapse rate after having successfully completed treatment. DM adversely affected the clinical presentation and treatment response of TB, but there was no difference in the drug resistance and relapse rates. © 2017 Asian Pacific Society of Respirology.

Heritability of HR and BP Response To Exercise Training in the HERITAGE Family Study.

ERIC Educational Resources Information Center

Rice, Treva; Gagnon, Jacques; Leon, Arthur S.; Skinner, James S.; Wilmore, Jack H.; Bouchard, Claude; Rao, D. C.

2002-01-01

Assessed the heritability of response to exercise training in resting blood pressure (BP) and heart rate (HR) among sedentary Caucasians comprising 98 families who completed an exercise training program. Results indicated that the trainability of systolic BP and HR in families with elevated BP was partially determined by genetic factors. Diastolic…

Improving Response Rates and Response Quality in Educational Survey Research.

ERIC Educational Resources Information Center

Tollefson, Nona; And Others

The purpose of this study was to apply the tenets of social exchange theory in developing cover letters for mailed surveys. A survey questionnaire designed to measure teachers' attitudes toward tests was mailed to 1200 Kansas teachers. Cover letters were written to create variation in perceived cost (time needed to complete the questionnaire) and…

Treatment adherence and outcome in women with inflammatory breast cancer: does race matter?

PubMed

Andic, Fundagul; Godette, Karen; O'Regan, Ruth; Zelnak, Amelia; Liu, Tian; Rizzo, Monica; Gabram, Sheryl; Torres, Mylin

2011-12-15

The authors compared treatment adherence rates and outcome in Caucasian and African American patients with inflammatory breast cancer (IBC). The records of 55 (25 Caucasian and 30 African American) IBC patients treated with curative intent from 1995 to 2009 were reviewed. All patients received neoadjuvant doxorubicin (Adriamycin) and/or taxane-based chemotherapy, and mastectomy with or without radiotherapy. The median follow-up period for Caucasian and African American patients was similar (39.5 months and 36.1 months, respectively). There was no difference between races in median age, tumor size, grade, and receptor status at diagnosis. The number of patients who completed neoadjuvant chemotherapy, surgery, and radiotherapy did not differ by race (84% of Caucasians vs 86.7% of African Americans) nor did the median length of time to complete trimodality treatment (263 [range, 207-422] days for Caucasians vs 262 [range, 165-371] days for African Americans). There was a trend toward slightly higher pathological complete response rates in Caucasian than African American women (20% in Caucasians vs 6.7% in African Americans, P = .23). Despite slightly better response rates to neoadjuvant chemotherapy, Caucasian patients did not have higher 3-year local control rates (70% in Caucasians vs 64% in African Americans, P = .73). However, there was a trend toward higher 3-year overall survival in Caucasian versus African American patients (73% in Caucasians vs 55% in African Americans, P = .09) and higher distant metastasis-free survival (60% in Caucasians vs 40% in African Americans, P = .19). This study is among the largest to examine patients with IBC by race. Being Caucasian or African American did not appear to impact treatment adherence. However, African American patients tended to have poorer response to standard treatment and worse outcome than Caucasian patients. Copyright © 2011 American Cancer Society.

Mental illness beliefs in Malaysia: ethnic and intergenerational comparisons.

PubMed

Edman, J L; Koon, T Y

2000-01-01

Two groups of college students in Malaysia, ethnic Malay and ethnic Chinese, completed a mental illness attribution and help seeking questionnaire, and these responses were also compared with the responses of their mothers. As expected, ethnic Malays rated religious items, such as God and prayer, higher than the Chinese. However, both groups rated the social and psychological causes higher than religious, supernatural or physical causes. Contrary to our predictions, there were no intergenerational differences among either ethnic group. Medical pluralism was demonstrated, as a variety of apparently contradictory help seeking behaviors received quite high ratings including doctor/pharmacy, prayer, herbal medicine and traditional healers.

Developing and Pilot Testing a Spanish Translation of CollaboRATE for Use in the United States.

PubMed

Forcino, Rachel C; Bustamante, Nitzy; Thompson, Rachel; Percac-Lima, Sanja; Elwyn, Glyn; Pérez-Arechaederra, Diana; Barr, Paul J

2016-01-01

Given the need for access to patient-facing materials in multiple languages, this study aimed to develop and pilot test an accurate and understandable translation of CollaboRATE, a three-item patient-reported measure of shared decision-making, for Spanish-speaking patients in the United States (US). We followed the Translate, Review, Adjudicate, Pre-test, Document (TRAPD) survey translation protocol. Cognitive interviews were conducted with Spanish-speaking adults within an urban Massachusetts internal medicine clinic. For the pilot test, all patients with weekday appointments between May 1 and May 29, 2015 were invited to complete CollaboRATE in either English or Spanish upon exit. We calculated the proportion of respondents giving the best score possible on CollaboRATE and compared scores across key patient subgroups. Four rounds of cognitive interviews with 26 people were completed between January and April 2015. Extensive, iterative refinements to survey items between interview rounds led to final items that were generally understood by participants with diverse educational backgrounds. Pilot data collection achieved an overall response rate of 73 percent, with 606 (49%) patients completing Spanish CollaboRATE questionnaires and 624 (51%) patients completing English CollaboRATE questionnaires. The proportion of respondents giving the best score possible on CollaboRATE was the same (86%) for both the English and Spanish versions of the instrument. Our translation method, guided by emerging best practices in survey and health measurement translation, encompassed multiple levels of review. By conducting four rounds of cognitive interviews with iterative item refinement between each round, we arrived at a Spanish language version of CollaboRATE that was understandable to a majority of cognitive interview participants and was completed by more than 600 pilot questionnaire respondents.

An Exploration of Learners' Conceptions of Language, Culture, and Learning in Advanced-Level Spanish Courses

ERIC Educational Resources Information Center

Drewelow, Isabelle; Mitchell, Claire

2015-01-01

This article reports on an exploratory study, which examines learners' rating of culture in relation to other concepts in advanced Spanish courses and their justification of the ratings attributed. Open-ended responses, elicited from a questionnaire completed by 179 respondents, were analysed line by line using an interpretive approach. Data…

Trust but Verify: Examining the Association between Students' Sourcing Behaviors and Ratings of Text Trustworthiness

ERIC Educational Resources Information Center

List, Alexandra; Alexander, Patricia A.; Stephens, Lori A.

2017-01-01

Three indicators of undergraduate students' (n = 197) source evaluation were investigated as students completed an academic task requiring the use of multiple texts. The source evaluation metrics examined were students' (1) accessing of document information, (2) trustworthiness ratings, and (3) citation in written responses. All three indicators…

Excess heart rate and systolic blood pressure during psychological stress in relation to metabolic demand in adolescents

USDA-ARS?s Scientific Manuscript database

Cardiovascular responses during exercise are matched to the increased metabolic demand, but this may not be the case during psychological stress. No studies to date have tested this hypothesis in youth. Fifty-four youth, ages 13-16 years completed two visits. Heart rate (HR), systolic blood pressu...

Personality as a Determinate of Response Dimension Scaling for Likert Rating Categories.

ERIC Educational Resources Information Center

Hensley, Wayne E.; Sanford, David L.

A study was designed to evaluate the use of summated rating (Likert) scales of agreement, evaluation, and frequency. The subjects, 58 female and 45 male college students, rank ordered the descriptive adjectives for the areas of agreement, evaluation, and frequency on a scale of 1 to 100. They also completed the Personal Report of Communication…

Investigating Chinese University Students' Knowledge of and Attitudes toward Plagiarism from an Integrated Perspective

ERIC Educational Resources Information Center

Hu, Guangwei; Lei, Jun

2012-01-01

This article reports on a mixed-methods study of Chinese university students' knowledge of and attitudes toward plagiarism in English academic writing. A sample of 270 undergraduates from two Chinese universities rated three short English passages under different conditions, provided open-ended responses to justify their ratings, and completed a…

Pathological response after neoadjuvant bevacizumab- or cetuximab-based chemotherapy in resected colorectal cancer liver metastases.

PubMed

Pietrantonio, Filippo; Mazzaferro, Vincenzo; Miceli, Rosalba; Cotsoglou, Christian; Melotti, Flavia; Fanetti, Giuseppe; Perrone, Federica; Biondani, Pamela; Muscarà, Cecilia; Di Bartolomeo, Maria; Coppa, Jorgelina; Maggi, Claudia; Milione, Massimo; Tamborini, Elena; de Braud, Filippo

2015-07-01

Neoadjuvant chemotherapy (NACT) prior to liver resection is advantageous for patients with colorectal cancer liver metastases (CLM). Bevacizumab- or cetuximab-based NACT may affect patient outcome and curative resection rate, but comparative studies on differential tumour regression grade (TRG) associated with distinct antibodies-associated regimens are lacking. Ninety-three consecutive patients received NACT plus bevacizumab (n = 46) or cetuximab (n = 47) followed by CLM resection. Pathological response was determined in each resected metastasis as TRG rated from 1 (complete) to 5 (no response). Except for KRAS mutations prevailing in bevacizumab versus cetuximab (57 vs. 21 %, p = 0.001), patients characteristics were well balanced. Median follow-up was 31 months (IQR 17-48). Bevacizumab induced significantly better pathological response rates (TRG1-3: 78 vs. 34 %, p < 0.001) as well as complete responses (TRG1: 13 vs. 0 %, p = 0.012) with respect to cetuximab. Three-year progression-free survival (PFS) and overall survival (OS) were not significantly different in the two cohorts. At multivariable analysis, significant association with pathological response was found for number of resected metastases (p = 0.015) and bevacizumab allocation (p < 0.001), while KRAS mutation showed only a trend. Significant association with poorer PFS and OS was found for low grades of pathological response (p = 0.009 and p < 0.001, respectively), R2 resection or presence of extrahepatic disease (both p < 0.001) and presence of KRAS mutation (p = 0.007 and p < 0.001, respectively). Bevacizumab-based regimens, although influenced by the number of metastases and KRAS status, improve significantly pathological response if compared to cetuximab-based NACT. Possible differential impact among regimens on patient outcome has still to be elucidated.

Psychiatric symptoms and response quality to self-rated personality tests: Evidence from the PsyCoLaus study.

PubMed

Dupuis, Marc; Meier, Emanuele; Rudaz, Dominique; Strippoli, Marie-Pierre F; Castelao, Enrique; Preisig, Martin; Capel, Roland; Vandeleur, Caroline L

2017-06-01

Despite the fact that research has demonstrated consistent associations between self-rated measures of personality dimensions and mental disorders, little has been undertaken to investigate the relation between psychiatric symptoms and response patterns to self-rated tests. The aim of this study was to investigate the association between psychiatric symptoms and response quality using indices from our functional method. A sample of 1,784 participants from a Swiss population-based cohort completed a personality inventory (NEO-FFI) and a symptom checklist of 90 items (SCL-90-R). Different indices of response quality were calculated based on the responses given to the NEO-FFI. Associations among the responses to indices of response quality, sociodemographic characteristics and the SCL-90-R dimensions were then established. Psychiatric symptoms were associated with several important differences in response quality, questioning subjects' ability to provide valid information using self-rated instruments. As suggested by authors, psychiatric symptoms seem associated with differences in personality scores. Nonetheless, our study shows that symptoms are also related to differences in terms of response patterns as sources of differences in personality scores. This could constitute a bias for clinical assessment. Future studies could still determine whether certain subpopulations of subjects are more unable to provide valid information to self-rated questionnaires than others. Copyright © 2017 Elsevier Ireland Ltd. All rights reserved.

The Role of Participant Responsiveness on a Socio-Emotional Learning Program.

PubMed

Pereira, Nádia Salgado; Marques-Pinto, Alexandra

2017-01-19

The present study set out to evaluate participant responsiveness, one of the main dimensions of implementation quality, in a Socio-Emotional Learning after-school program using Educational Dance activities, Experiencing Emotions, and also to understand its influence on program outcomes. The sample involved 98 middle-school Portuguese pupils, 53 of whom participated in the program and 45 in after-school control sessions. Outcome measures included pre-test and post-test questionnaires of pupils' socio-emotional skills, well-being and school engagement. A self-report item measured pupils' satisfaction at the end of the program, and a checklist measuring attendance and homework completion was filled in by the facilitator at each session of the program and control condition. Results revealed (1) high levels of pupils' satisfaction and attendance, and a medium-high level of homework completion towards the program; (2) that pupils' higher attendance rate in the program predicted higher results in the self-management (p = .04, d = .57; p = .003, d = .87) and social awareness (p = .04, d = .59) SEL domains, emotional (p = .02, d = .67) and psychological (p = .009, d = .76) well-being and school engagement (p = .04, d = .56); (3) that pupils' higher rate of homework completion in the program predicted higher results in the relationship skills SEL area (p = .04, d = .59) and in school engagement (p = .005, d = 1.50); (4) that pupils' from the control condition higher rates of homework completion also predicted better school engagement (p = .006, d = .88). Implications for research and practice are discussed.

Extensive disease small cell carcinoma of the lung; trial of non-cross resistant chemotherapy and consolidation radiotherapy. [X ray

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

Dillman, R.O., Taelle, R., Segren, S.; Royston, I.; Koziol, J.

1982-05-15

Twenty-nine patients with extensive disease, small-cell carcinoma of the lung, were treated with two cycles of intensive combination chemotherapy: HexaVAC (hexamethylmelamine, vincristine, Adriamycin, cyclophosphamide). Responders received prophylactic cranial radiation (2000 rad/10 fractions) and non cross resistant chemotherapy via a schedule of alternating cycles of CMV (cyclophosphamide, methotrexate, VP-16-213) and AMV (Adriamycin, methotrexate, VP-16-213). Whenever a complete response was achieved, consolidation radiotherapy was given to the lung primary (4000 rad/20 fractions, split dose) and abdominal metastases (2000 rad/10 fractions) synchronous with CMV therapy. The complete response rate was 14% with HexaVAC, but increased to 38% during CMV/AMV. Total response rate (completemore » and partial) was 59% and median survival was 42 weeks. Prophylactic brain radiation prevented clinical relapse in the brain in all 14 patients who received it. However, consolidation radiotherapy failed to prevent clinical relapse in the lung and/or liver, and therapeutic brain radiation (3000 rad) failed to prevent relapse in that site. The simultaneous administration of radiotherapy and chemotherapy was well-tolerated although two patients with poor performance status died of infectious complications while leukopenic. In spite of the high response rate, durable remissions with prolonged disease free survival were rare. Further evaluation of induction, consolidation, and maintenance modes of therapy are indicated.« less

Incentives for college student participation in web-based substance use surveys.

PubMed

Patrick, Megan E; Singer, Eleanor; Boyd, Carol J; Cranford, James A; McCabe, Sean Esteban

2013-03-01

The purpose of this study was to examine the effects of two incentive conditions (a $10 pre-incentive only vs. a $2 pre-incentive and a $10 promised incentive) on response rates, sample composition, substantive data, and cost-efficiency in a survey of college student substance use and related behaviors. Participants were 3000 randomly-selected college students invited to participate in a survey on substance use. Registrar data on all invitees was used to compare response rates and respondents, and web-based data collection on participants was used to compare substantive findings. Participants randomized to the pre-incentive plus promised incentive condition were more likely to complete the survey and less likely to give partial responses. Subgroup differences by sex, class year, and race were evaluated among complete responders, although only sex differences were significant. Men were more likely to respond in the pre-incentive plus promised incentive condition than the pre-incentive only condition. Substantive data did not differ across incentive structure, although the pre-incentive plus promised incentive condition was more cost-efficient. Survey research on college student populations is warranted to support the most scientifically sound and cost-efficient studies possible. Although substantive data did not differ, altering the incentive structure could yield cost savings with better response rates and more representative samples. Copyright © 2012 Elsevier Ltd. All rights reserved.

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.

Effect of radiation therapy on bronchial obstruction due to bronchogenic carcinoma

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

Chetty, K.G.; Moran, E.M.; Sassoon, C.S.

1989-03-01

We evaluated the effect of radiation therapy in 57 patients with obstruction of a large bronchus with NSCC. Response with aeration of the atelectatic lung was seen in 12 patients (21 percent). Three patients (5 percent) showed partial response with persistent partial atelectasis, and nine patients (16 percent) showed good response with complete aeration of the atelectatic lung. In these patients the response appeared to be related to the dose of radiation. All of the patients who responded received more than 50 Gy. The difference in the response rate related to the dose of radiation was statistically significant (p lessmore » than 0.05). The rates were similar with all histologic types of NSCC. Regardless of the clinical response observed, bronchoscopy performed two to four months after completion of radiation therapy in 14 patients revealed persistent endobronchial tumor. There was no significant relationship between the persistence of endobronchial tumor, the dose of radiation therapy, and the tumor's histologic type. Of the 12 patients with radiographic improvement in atelectasis, fibrotic changes developed in four (33 percent) patients and pneumonitis in two (17 percent). Progression of disease with distant metastases occurred in 58 percent (seven) of the 12 patients who showed a clinical response of their bronchial obstruction. The median time to survival was nearly identical in responders and nonresponders.« less

Alternative Reinforcer Response Cost Impacts Methamphetamine Choice in Humans

PubMed Central

Bennett, J. Adam; Stoops, William W.; Rush, Craig R.

2012-01-01

Methamphetamine use disorders are a persistent public health concern. Behavioral treatments have demonstrated that providing access to non-drug alternative reinforcers reduces methamphetamine use. The purpose of this human laboratory experiment was to determine how changes in response cost for non-drug alternative reinforcers influenced methamphetamine choice. Seven subjects with past year histories of recreational stimulant use completed a placebo-controlled, crossover, double-blind protocol in which they first sampled doses of oral methamphetamine (0, 8 or 16 mg) and completed a battery of subject-rated and physiological measures. During subsequent sessions, subjects then made eight discrete choices between 1/8th of the sampled dose and an alternative reinforcer ($0.25). The response cost to earn a methamphetamine dose was always 500 responses (FR500). The response cost for the alternative reinforcer varied across sessions (FR500, FR1000, FR2000, FR3000). Methamphetamine functioned as a positive reinforcer and produced prototypical stimulant-like effects (e.g., elevated blood pressure, increased ratings of “Stimulated”). Choice for doses over money was sensitive to changes in response cost for alternative reinforcers in that more doses were taken at higher FR values than at lower FR values. Placebo choices changed as a function of alternative reinforcer response cost to a greater degree than active methamphetamine choices. These findings suggest that manipulating the effort necessary to earn alternative reinforcers could impact methamphetamine use. PMID:23046851

User's guide to computer program CIVM-JET 4B to calculate the transient structural responses of partial and/or complete structural rings to engine-rotor-fragment impact

NASA Technical Reports Server (NTRS)

Stagliano, T. R.; Spilker, R. L.; Witmer, E. A.

1976-01-01

A user-oriented computer program CIVM-JET 4B is described to predict the large-deflection elastic-plastic structural responses of fragment impacted single-layer: (a) partial-ring fragment containment or deflector structure or (b) complete-ring fragment containment structure. These two types of structures may be either free or supported in various ways. Supports accommodated include: (1) point supports such as pinned-fixed, ideally-clamped, or supported by a structural branch simulating mounting-bracket structure and (2) elastic foundation support distributed over selected regions of the structure. The initial geometry of each partial or complete ring may be circular or arbitrarily curved; uniform or variable thicknesses of the structure are accommodated. The structural material is assumed to be initially isotropic; strain hardening and strain rate effects are taken into account.

Brentuximab vedotin in relapsed/refractory Hodgkin’s lymphoma: the Italian experience and results of its use in daily clinical practice outside clinical trials

PubMed Central

Zinzani, Pier Luigi; Viviani, Simonetta; Anastasia, Antonella; Vitolo, Umberto; Luminari, Stefano; Zaja, Francesco; Corradini, Paolo; Spina, Michele; Brusamolino, Ercole; Gianni, Alessandro M.; Santoro, Armando; Botto, Barbara; Derenzini, Enrico; Pellegrini, Cinzia; Argnani, Lisa

2013-01-01

Clinical trial results indicate that brentuximab vedotin brings considerable promise for the treatment of patients with relapsed or refractory Hodgkin’s lymphoma. A retrospective multicenter study was conducted on 65 heavily pretreated patients who underwent therapy through a Named Patient Program in Italy (non trial-setting). The primary study endpoint was the objective response rate; secondary endpoints were safety, overall survival and progression-free survival. The best overall response rate (70.7%), including 21.5% complete responses, was observed at the first restaging after the third cycle of treatment. After a median follow up of 13.2 months, the overall survival rate at 20 months was 73.8% while the progression-free survival rate at 20 months was 24.2%. Globally nine patients are in continuous complete response with a median follow up of 14 months (range, 10–19 months). Four patients proceeded to autotransplantation and nine to allotransplantation. The most frequent extra-hematologic toxicity was peripheral neuropathy, observed in 21.5% of cases (9 patients with grade 1/2 and 5 patients with grade 3/4); neurological toxicity led to discontinuation of treatment in three patients and to dose reduction in four. In general the treatment was well tolerated and toxicities, both hematologic and extra-hematologic, were manageable. This report indicates and confirms that brentuximab vedotin as a single agent is effective and safe also when used in standard, everyday clinical practice outside a clinical trial. Best overall responses were recorded after three or four cycles and showed that brentuximab vedotin provides an effective bridge to further therapeutic interventions. PMID:23645687

Long-term survival based on pathologic response to neoadjuvant therapy in esophageal cancer.

PubMed

Tiesi, Gregory; Park, Wungki; Gunder, Meredith; Rubio, Gustavo; Berger, Michael; Ardalan, Bach; Livingstone, Alan; Franceschi, Dido

2017-08-01

Neoadjuvant treatment is standard for locally advanced esophageal cancer. However, whether the addition of radiation to neoadjuvant regimen improves survival remains unclear. The aim of this study was to compare survival in locally advanced esophageal cancer treated with neoadjuvant chemotherapy versus chemoradiation. A prospectively maintained database of esophagectomies (1999-2012) was analyzed. We identified 297 patients with locally advanced esophageal cancer that underwent either neoadjuvant chemotherapy (n = 231) or chemoradiation (n = 66) followed by esophagectomy. Pretreatment and pathologic staging were compared to assess response. Overall survival was recorded. Most patients in the chemotherapy and chemoradiation groups had pretreatment stage III disease (66.7% versus 65.2%; P = 0.44). Median follow-up was 79.3 and 64.9 mo for chemotherapy and chemoradiation cohorts, respectively. Complete response rate was higher in chemoradiation than chemotherapy groups (30.3% versus 13.8%; P < 0.001). Overall survival was similar between complete responders in both groups (median not reached versus 121.1 mo; chemotherapy versus chemoradiation). However, partial responders in the chemotherapy cohort had improved median survival (147.2 mo) versus those in the chemoradiation cohort (83.7 mo, P < 0.03). Within the chemotherapy-only group, partial responders had improved survival compared with nonresponders (P = 0.041); however, there was no difference in survival between partial and complete responders (P = 0.36). In patients undergoing esophagectomy for locally advanced esophageal cancer, neoadjuvant chemotherapy was associated with an equivalent overall survival, when compared with neoadjuvant chemoradiotherapy. Adding neoadjuvant radiation may enhance complete response rates but does not appear to be associated with improved survival. Copyright © 2017 Elsevier Inc. All rights reserved.

Predictors of Response Rates to a Long Term Follow-Up Mail out Survey

PubMed Central

Koloski, Natasha A.; Jones, Michael; Eslick, Guy; Talley, Nicholas J.

2013-01-01

Objective Very little is known about predictors of response rates to long-term follow-up mail-out surveys, including whether the timing of an incentive affects response rates. We aimed to determine whether the timing of the incentive affects response rates and what baseline demographic and psychological factors predict response rates to a 12 year follow-up survey. Study design and setting: Participants were 450 randomly selected people from the Penrith population, Australia who had previously participated in a mail-out survey 12 years earlier. By random allocation, 150 people received no incentive, 150 received a lottery ticket inducement with the follow-up survey and 150 received a lottery ticket inducement on the return of a completed survey. Results The overall response rate for the study was 63%. There were no significant differences in terms of response rates between the no incentive (58.8%;95%CI 49.8%,67.3%), incentive with survey (65.1%;95%CI 56.2%,73.3%) and promised incentive (65.3%;95%CI 56.1%,73.7%) groups. Independent predictors of responding to the 12 year survey were being older (OR=1.02, 95%CI 1.01,1.05,P=0.001) and being less neurotic as reported on the first survey 12 years earlier (OR=0.92, 95%CI 0.86,0.98, P=0.010). Conclusions Psychological factors may play a role in determining who responds to long-term follow-up surveys although timing of incentives does not. PMID:24223902

Species Profiles: Life Histories and Environmental Requirements of Coastal Fishes and Invertebrates (North and Mid-Atlantic)

DTIC Science & Technology

1989-06-01

completely, oceanic salinities (34 ppt) to mesohaline (5-18 and metabolic rate partly, to a sinusoidal ppt) estuarine conditions (Bayne et al. 1976a... salinity change is large Newfoundland acclimated neither their feeding enough (reviewed by Davenport 1982). It can rate nor their metabolic rate to...mediating their conditions, and energ, requirements are response to a salinity change. Although larvae supplied by anaerobic metabolic pathways from the

Promoting a bicycle-friendly environment: community assessment and action.

PubMed

Sharpe, Patricia; Burroughs, Erika; Hooker, Steven; Pekuri, Linda; Blumberg, Catherine; Hutto, Brent

2011-01-01

Researchers and community coalition members collected survey data and used it to guide production of an educational video promoting a bicycle-friendly environment. Telephone and mailed surveys were conducted among bicyclists and motorists for needs assessment. A sample of 173 bicyclists completed a mailed survey (response rate of 87.0%), and a sample of 801 motorists completed a telephone survey (response rate of 42.1%). Findings guided video production. Most motorists understood that bicyclists have a right to ride in the road, but about one half believed bicyclists create a hazard, even when they follow traffic laws. Bicyclists expressed safety concerns and felt threatened by motorists. Both motorists' and bicyclists' knowledge of traffic rules varied across the items. This project illustrates how community members can apply research findings to an educational video of high quality with local relevance. The leadership from community members in making the video set the foundation for local ownership.

Erosive burning research. [for solid-propellant rocket engines

NASA Technical Reports Server (NTRS)

Strand, L.; Yang, L. C.; Nguyen, M. H.; Cohen, N. S.

1986-01-01

A status report is given on the results for the completed tests in a series of motor firings being carried out to measure the effects of the parameters that are considered to most strongly influence the scaling to larger rocket motor sizes of the transition to/or threshold conditions for erosive burning rate augmentation. Propellant burning rates at locations along the axis of the test motors are measured with a newly developed plasma capacitance gauge technique. The measured results are compared with erosive-burning predictions from a supporting ballistics analysis. The completed motor firings have successfully demonstrated response to the designed test variables. The trends with varying propellant burning rate, chamber pressure, and mass flow rate are consistent with existing results, but no pronounced effect of surface roughness has been observed. Rather, the influence of propellant oxidizer particle size on erosive burning is through its effect on the base, no-corssflow burning rate.

Response to treatment and interval to surgery after preoperative short-course radiotherapy in rectal cancer.

PubMed

García-Cabezas, Sonia; Rodríguez-Liñán, Milagrosa; Otero-Romero, Ana M; Bueno-Serrano, Carmen M; Gómez-Barbadillo, José; Palacios-Eito, Amalia

2016-10-01

Preoperative short-course radiotherapy with immediate surgery improves local control in patients with rectal cancer. Tumor responses are smaller than those described with radiochemotherapy. Preliminary data associate this lower response to the short period until surgery. The aim of this study is to analyze the response to preoperative short-course radiotherapy and its correlation with the interval to surgery especially analyzing patients with mesorectal fascia involvement. A total of 155 patients with locally advanced rectal cancer treated with preoperative radiotherapy (5×5Gy) were retrospectively analyzed. Tumor response in terms of rates of complete pathological response, downstaging, tumor regression grading and status of the circumferential resection margin were quantified. The mean interval from radiotherapy to surgery was 23 days. The rate of complete pathological response was 2.2% and 28% experienced downstaging (stage decreased). No differences between these rates and interval to surgery were detected. Eighty-eight patients had magnetic resonance imaging for staging (in 31 patients the mesorectal fascia was involved).The mean time to surgery in patients with involvement of the fascia and R0 surgery was 27 days and 16 days if R1 (P=.016). The cutoff of 20 days reached the highest probability of achieving a free circumferential resection margin between patients with mesorectal fascia involvement, with no statistically significant differences: RR 3.036 95% CI=(0.691-13.328), P=.06. After preoperative short-course radiotherapy, an interval>20 days enhances the likelihood of achieving a free circumferential resection margin in patients with mesorectal fascia involvement. Copyright © 2016 AEC. Publicado por Elsevier España, S.L.U. All rights reserved.

The Use of Multiple Imputation for Missing Data in Uniform DIF Analysis: Power and Type I Error Rates

ERIC Educational Resources Information Center

Finch, Holmes

2011-01-01

Methods of uniform differential item functioning (DIF) detection have been extensively studied in the complete data case. However, less work has been done examining the performance of these methods when missing item responses are present. Research that has been done in this regard appears to indicate that treating missing item responses as…

Item Response Theory Analyses of Parent and Teacher Ratings of the ADHD Symptoms for Recoded Dichotomous Scores

ERIC Educational Resources Information Center

Gomez, Rapson; Vance, Alasdair; Gomez, Andre

2011-01-01

Objective: The two-parameter logistic model (2PLM) was used to evaluate the psychometric properties of the inattention (IA) and hyperactivity/impulsivity (HI) symptoms. Method: To accomplish this, parents and teachers completed the Disruptive Behavior Rating Scale (DBRS) for a group of 934 primary school-aged children. Results: The results for the…

Germination of Sweetgum in Response to Temherature, Moisture Stress, and Length of Stratification

Treesearch

F. T. Bonner; R. E. Farmer

1966-01-01

Both total germination and rate of germination of sweetgum seed increased as temperatures were raised from 60-75 to 85-100°F. Increases in osmotic stress lessened total germination and rate of germination, and 15 atmospheres of stress completely inhibited germination. Raising the temperatures decreased the influence of osmotic stress, and lengthening the stratification...

Cardiovascular responses associated with daily walking in subacute stroke.

PubMed

Prajapati, Sanjay K; Mansfield, Avril; Gage, William H; Brooks, Dina; McIlroy, William E

2013-01-01

Despite the importance of regaining independent ambulation after stroke, the amount of daily walking completed during in-patient rehabilitation is low. The purpose of this study is to determine if (1) walking-related heart rate responses reached the minimum intensity necessary for therapeutic aerobic exercise (40%-60% heart rate reserve) or (2) heart rate responses during bouts of walking revealed excessive workload that may limit walking (>80% heart rate reserve). Eight individuals with subacute stroke attending in-patient rehabilitation were recruited. Participants wore heart rate monitors and accelerometers during a typical rehabilitation day. Walking-related changes in heart rate and walking bout duration were determined. Patients did not meet the minimum cumulative requirements of walking intensity (>40% heart rate reserve) and duration (>10 minutes continuously) necessary for cardiorespiratory benefit. Only one patient exceeded 80% heart rate reserve. The absence of significant increases in heart rate associated with walking reveals that patients chose to walk at speeds well below a level that has meaningful cardiorespiratory health benefits. Additionally, cardiorespiratory workload is unlikely to limit participation in walking. Measurement of heart rate and walking during in-patient rehabilitation may be a useful approach to encourage patients to increase the overall physical activity and to help facilitate recovery.

Multicenter phase II study of weekly docetaxel, cisplatin, and S-1 (TPS) induction chemotherapy for locally advanced squamous cell cancer of the head and neck.

PubMed

Bae, Woo Kyun; Hwang, Jun Eul; Shim, Hyun Jeong; Cho, Sang Hee; Lee, Ki Hyeong; Han, Hye Suk; Song, Eun-Kee; Yun, Hwan Jung; Cho, In Sung; Lee, Joon Kyoo; Lim, Sang-Chul; Chung, Woong-Ki; Chung, Ik-Joo

2013-03-06

The purpose of this study was to evaluate the efficacy and tolerability of weekly docetaxel, cisplatin, and S-1 (weekly TPS) as induction chemotherapy for patients with locally advanced head and neck squamous cell carcinoma (HNSCC). A total of 35 patients with previously untreated, locally advanced HNSCC were enrolled. Seven patients (20%) were diagnosed with stage III HNSCC and 28 patients (80%) were diagnosed with stage IV. Induction treatment included 30 mg/m(2) docetaxel on day 1 and 8, 60 mg/m(2) cisplatin on day 1, and 70 mg/m(2) S-1 on days 1 to 14. The regimen was repeated every 21 days. After three courses of induction chemotherapy, patients received concurrent chemoradiotherapy. Among the 35 patients, 30 (85.7%) completed induction chemotherapy. The response to induction chemotherapy was as follows: nine patients (25.7%) achieved a complete response (CR) and the overall response rate (ORR) was 85.7%. Grades 3-4 toxicity during induction therapy included neutropenia (28.5%), neutropenic fever (8.5%), and diarrhea (17.1%). After completion of concurrent chemoradiotherapy, the CR rate was 62.8% and the partial response (PR) was 22.8%. Estimates of progression-free and overall survival at 2 years were 73.2% and 79.3%, respectively. Weekly TPS is a promising regimen that is well-tolerated, causes minimal myelosuppression and is effective as an outpatient regimen for locally advanced HNSCC. ClinicalTrials.gov: NCT01645748.

Cyclophosphamide, thalidomide, and dexamethasone (CTD) as initial therapy for patients with multiple myeloma unsuitable for autologous transplantation

PubMed Central

Davies, Faith E.; Gregory, Walter M.; Russell, Nigel H.; Bell, Sue E.; Szubert, Alexander J.; Coy, Nuria Navarro; Cook, Gordon; Feyler, Sylvia; Byrne, Jenny L.; Roddie, Huw; Rudin, Claudius; Drayson, Mark T.; Owen, Roger G.; Ross, Fiona M.; Jackson, Graham H.; Child, J. Anthony

2011-01-01

As part of the randomized MRC Myeloma IX trial, we compared an attenuated regimen of cyclophosphamide, thalidomide, and dexamethasone (CTDa; n = 426) with melphalan and prednisolone (MP; n = 423) in patients with newly diagnosed multiple myeloma ineligible for autologous stem-cell transplantation. The primary endpoints were overall response rate, progression-free survival, and overall survival (OS). The overall response rate was significantly higher with CTDa than MP (63.8% vs 32.6%; P < .0001), primarily because of increases in the rate of complete responses (13.1% vs 2.4%) and very good partial responses (16.9% vs 1.7%). Progression-free survival and OS were similar between groups. In this population, OS correlated with the depth of response (P < .0001) and favorable interphase fluorescence in situ hybridization profile (P < .001). CTDa was associated with higher rates of thromboembolic events, constipation, infection, and neuropathy than MP. In elderly patients with newly diagnosed multiple myeloma (median age, 73 years), CTDa produced higher response rates than MP but was not associated with improved survival outcomes. We highlight the importance of cytogenetic profiling at diagnosis and effective management of adverse events. This trial was registered at International Standard Randomized Controlled Trials Number as #68454111. PMID:21652683

Evaluating Tablet Computers as a Survey Tool in Rural Communities

PubMed Central

Newell, Steve M.; Logan, Henrietta L.; Guo, Yi; Marks, John G.; Shepperd, James A.

2015-01-01

Purpose Although tablet computers offer advantages in data collection over traditional paper-and-pencil methods, little research has examined whether the 2 formats yield similar responses, especially with underserved populations. We compared the 2 survey formats and tested whether participants’ responses to common health questionnaires or perceptions of usability differed by survey format. We also tested whether we could replicate established paper-and-pencil findings via tablet computer. Methods We recruited a sample of low-income community members living in the rural southern United States. Participants were 170 residents (black = 49%; white = 36%; other races and missing data = 15%) drawn from 2 counties meeting Florida’s state statutory definition of rural with 100 persons or fewer per square mile. We randomly assigned participants to complete scales (Center for Epidemiologic Studies Depression Inventory and Regulatory Focus Questionnaire) along with survey format usability ratings via paper-and-pencil or tablet computer. All participants rated a series of previously validated posters using a tablet computer. Finally, participants completed comparisons of the survey formats and reported survey format preferences. Findings Participants preferred using the tablet computer and showed no significant differences between formats in mean responses, scale reliabilities, or in participants’ usability ratings. Conclusions Overall, participants reported similar scales responses and usability ratings between formats. However, participants reported both preferring and enjoying responding via tablet computer more. Collectively, these findings are among the first data to show that tablet computers represent a suitable substitute among an underrepresented rural sample for paper-and-pencil methodology in survey research. PMID:25243953

Evaluating tablet computers as a survey tool in rural communities.

PubMed

Newell, Steve M; Logan, Henrietta L; Guo, Yi; Marks, John G; Shepperd, James A

2015-01-01

Although tablet computers offer advantages in data collection over traditional paper-and-pencil methods, little research has examined whether the 2 formats yield similar responses, especially with underserved populations. We compared the 2 survey formats and tested whether participants' responses to common health questionnaires or perceptions of usability differed by survey format. We also tested whether we could replicate established paper-and-pencil findings via tablet computer. We recruited a sample of low-income community members living in the rural southern United States. Participants were 170 residents (black = 49%; white = 36%; other races and missing data = 15%) drawn from 2 counties meeting Florida's state statutory definition of rural with 100 persons or fewer per square mile. We randomly assigned participants to complete scales (Center for Epidemiologic Studies Depression Inventory and Regulatory Focus Questionnaire) along with survey format usability ratings via paper-and-pencil or tablet computer. All participants rated a series of previously validated posters using a tablet computer. Finally, participants completed comparisons of the survey formats and reported survey format preferences. Participants preferred using the tablet computer and showed no significant differences between formats in mean responses, scale reliabilities, or in participants' usability ratings. Overall, participants reported similar scales responses and usability ratings between formats. However, participants reported both preferring and enjoying responding via tablet computer more. Collectively, these findings are among the first data to show that tablet computers represent a suitable substitute among an underrepresented rural sample for paper-and-pencil methodology in survey research. Published 2014. This article is a U.S. Government work and is in the public domain in the USA.

The Role of Left Hemispheric Structures for Emotional Processing as a Monitor of Bodily Reaction and Felt Chill - a Case-Control Functional Imaging Study.

PubMed

Grunkina, Viktoria; Holtz, Katharina; Klepzig, Kai; Neubert, Jörg; Horn, Ulrike; Domin, Martin; Hamm, Alfons O; Lotze, Martin

2016-01-01

Background: The particular function of the left anterior human insula on emotional arousal has been illustrated with several case studies. Only after left hemispheric insula lesions, patients lose their pleasure in habits such as listening to joyful music. In functional magnetic resonance imaging studies (fMRI) activation in the left anterior insula has been associated with both processing of emotional valence and arousal. Tight interactions with different areas of the prefrontal cortex are involved in bodily response monitoring and cognitive appraisal of a given stimulus. Therefore, a large left hemispheric lesion including the left insula should impair the bodily response of chill experience (objective chill response) but leave the cognitive aspects of chill processing (subjective chill response) unaffected. Methods: We investigated a patient (MC) with a complete left hemispheric media cerebral artery stroke, testing fMRI representation of pleasant (music) and unpleasant (harsh sounds) chill response. Results: Although chill response to both pleasant and unpleasant rated sounds was confirmed verbally at passages also rated as chilling by healthy participants, skin conductance response was almost absent in MC. For a healthy control (HC) objective and subjective chill response was positively associated. Bilateral prefrontal fMRI-response to chill stimuli was sustained in MC whereas insula activation restricted to the right hemisphere. Diffusion imaging together with lesion maps revealed that left lateral tracts were completely damaged but medial prefrontal structures were intact. Conclusion: With this case study we demonstrate how bodily response and cognitive appraisal are differentially participating in the internal monitor of chill response.

[Analysis of the impact of decitabine treatment cycles on efficacy and safety in patients of myelodysplastic syndrome-refractory anemia with excess blasts].

PubMed

Luo, X P; Xu, Z F; Qin, T J; Zhang, Y; Zhang, H L; Fang, L W; Pan, L J; Hu, N B; Qu, S Q; Li, B; Xiao, Z J

2016-10-14

Objective: To explore the impact of decitabine treatment cycles on efficacy and adverse events(AEs)in patients of myelodysplastic syndrome-refractory anemia with excess blasts(MDSRAEB). Methods: A total of fifty-six patients with MDS-RAEB who received decitabine 20 mg·m -2 ·d -1 by IV infusion daily for 5 consecutive days every 4 weeks at a single institute in China were enrolled from December 2008 to March 2016. Their clinical features, efficacy, predictors of efficacy and AEs were analyzed retrospectively. Results: Of the 56 patients enrolled, 25 cases were MDS- RAEB1, another 31 were MDS-RAEB2. A median of 3 cycles(range, 1-15 cycles)were delivered. The overall response rate was 67.9%(10 complete responses, 8 marrow complete responses without hematologic improvement, 17 marrow complete responses with hematologic improvements, and 3 hematologic improvements). With a median follow-up duration of 7.9(1.0-56.3)months, the median overall survival was 21.1(95% CI 16.0- 26.1)months. Compared with RAEB-2, RAEB-1 predicted higher overall response rates in a multivariate analysis. Of the 38 patients who experienced clinical responses, initial responses were detected by the end of two cycles in 37 patients. Twenty- five of the 38 patients who experienced clinical responses had their best response within the first two cycles, and 37 cases of the patients achieved best response by the end of fourth cycles. Grade 3 or 4 cytopenia and infection were the most prevalent AEs, which occurred frequently in the early courses and decreased later, and other non- hematologic AEs were rare. Conclusion: Decitabine treatment was favorable in patients with MDS- RAEB. In most of the cases, initial responses were observed within 2 cycles, and best response was achieved by the end of 4 th cycles. The most common AEs were grade 3 or 4 cytopenia and infection, which were observed frequently in first 2 cycles and decreased later as objective response were achieved.

Efficacy and influence factors of icotinib hydrochloride in treating advanced non-small cell lung cancer.

PubMed

Ma, X-H; Tian, T-D; Liu, H-M; Li, Q-J; Gao, Q-L; Li, L; Shi, B

2017-01-01

To evaluate the efficacy and safety of icotinib hydrochloride in the treatment of patients with advanced non-small cell lung cancer (NSCLC) and discuss the influence factors on efficacy. 120 treatment-experienced patients confirmed by pathology or cytology with stage III B-IV non-small cell lung cancer took icotinib hydrochloride and erlotinib orally until the occurrence of disease progression or serious adverse reactions. Then, the efficacy of icotinib hydrochloride and the related influence factors were analyzed. In icotinib hydrochloride group, the response rate and the disease control rate were 30.00% and 65.00%, and the median progression-free survival time was 179 days (95% CI: 103.21-254.78); in erlotinib group, the response rate and the disease control rate were 25.00% and 56.70%, and the median progression-free survival time was 121 days (95% CI: 95.05-146.94). Moreover, the objective response rate and the disease control rate of second-line therapy were both superior to the third-line and above therapy. The objective response rate of patients with complete response/partial response/stable disease after the first-line therapy was higher than that of patients without response after the first-line therapy (p<0.05), and the significant differences existed in the objective response rate and the disease control rate among mutant group, wild-type group, and unknown group (p<0.05). The response rate and the disease control rate of erythra group were higher than those of non-erythra group (p<0.05). It was showed in the univariate analysis that the progression-free survival was correlated with the smoking status and the epidermal growth factor receptor gene mutations. The icotinib hydrochloride is effective and safe in treating the treatment-experienced patients with advanced NSCLC, especially for patients with sensitive mutations.

National survey of physicians to determine the effect of unconditional incentives on response rates of physician postal surveys

PubMed Central

Abdulaziz, Kasim; Brehaut, Jamie; Taljaard, Monica; Émond, Marcel; Sirois, Marie-Josée; Lee, Jacques S; Wilding, Laura; Perry, Jeffrey J

2015-01-01

Objectives Physicians are a commonly targeted group in health research surveys, but their response rates are often relatively low. The goal of this paper was to evaluate the effect of unconditional incentives in the form of a coffee card on physician postal survey response rates. Design Following 13 key informant interviews and eight cognitive interviews a survey questionnaire was developed. Participants A random sample of 534 physicians, stratified by physician group (geriatricians, family physicians, emergency physicians) was selected from a national medical directory. Setting Using computer generated random numbers; half of the physicians in each stratum were allocated to receive a coffee card to a popular national coffee chain together with the first survey mailout. Interventions The intervention was a $10 Tim Hortons gift card given to half of the physicians who were randomly allocated to receive the incentive. Results 265 (57.0%) physicians completed the survey. The response rate was significantly higher in the group allocated to receive the incentive (62.7% vs 51.3% in the control group; p=0.01). Conclusions Our results indicate that an unconditional incentive in the form of a coffee gift card can substantially improve physician response rates. Future research can look at the effect of varying amounts of cash on the gift cards on response rates. PMID:25694460

Comparison of 10 efficient protocols for photodynamic therapy of actinic keratosis: How relevant are effective light dose and local damage in predicting the complete response rate at 3 months?

PubMed

Vignion-Dewalle, Anne-Sophie; Baert, Gregory; Thecua, Elise; Lecomte, Fabienne; Vicentini, Claire; Abi-Rached, Henry; Mortier, Laurent; Mordon, Serge

2018-04-18

Topical photodynamic therapy is an established treatment modality for various dermatological conditions, including actinic keratosis. In Europe, the approved protocols for photodynamic therapy of actinic keratosis involve irradiation with either an Aktilite CL 128 lamp or daylight, whereas irradiation with the Blu-U illuminator is approved in the United States. Many other protocols using irradiation by a variety of light sources are also clinically efficient. This paper aims to compare 10 different protocols with clinically proven efficacy for photodynamic therapy of actinic keratosis and the available spectral irradiance of the light source. Effective irradiance, effective light dose, and local damage are compared. We also investigate whether there is an association between the complete response rate at 3 months and the effective light dose or local damage. The effective irradiance, also referred to as protoporphyrin IX-weighted irradiance, is obtained by integrating the spectral irradiance weighted by the normalized absorption spectrum of protoporphyrin IX over the wavelength. Integrating the effective irradiance over the irradiation time yields the effective light dose, which is also known as the protoporphyrin IX-weighted light dose. Local damage, defined as the total cumulative singlet oxygen molecules produced during treatment, is estimated using mathematical modeling of the photodynamic therapy process. This modeling is based on an iterative procedure taking into account the spatial and temporal variations in the protoporphyrin IX absorption spectrum during treatment. The protocol for daylight photodynamic therapy on a clear sunny day, the protocol for daylight photodynamic therapy on an overcast day, the photodynamic therapy protocol for a white LED lamp for operating rooms and the photodynamic therapy protocol for the Blu-U illuminator perform better than the six other protocols-all involving red light illumination-in terms of both effective light dose and local damage. However, no association between the complete response rate at 3 months and the effective light dose or local damage was found. Protocols that achieve high complete response rates at 3 months and low pain scores should be preferred regardless of the effective light dose and local damage. Lasers Surg. Med. © 2018 Wiley Periodicals, Inc. © 2018 Wiley Periodicals, Inc.

Blade loss transient dynamic analysis of turbomachinery

NASA Technical Reports Server (NTRS)

Stallone, M. J.; Gallardo, V.; Storace, A. F.; Bach, L. J.; Black, G.; Gaffney, E. F.

1982-01-01

This paper reports on work completed to develop an analytical method for predicting the transient non-linear response of a complete aircraft engine system due to the loss of a fan blade, and to validate the analysis by comparing the results against actual blade loss test data. The solution, which is based on the component element method, accounts for rotor-to-casing rubs, high damping and rapid deceleration rates associated with the blade loss event. A comparison of test results and predicted response show good agreement except for an initial overshoot spike not observed in test. The method is effective for analysis of large systems.

The Relationship between Rumination and Affective, Cognitive, and Physiological Responses to Stress in Adolescents.

PubMed

Aldao, Amelia; McLaughlin, Katie A; Hatzenbuehler, Mark L; Sheridan, Margaret A

Although previous studies have established that rumination influences responses to stressful life events, the mechanisms underlying this relationship remain inadequately understood. The current study examines the relationship between trait rumination and affective, cognitive, and physiological responses to a standardized laboratory-based stressor in adolescents. A community-based sample of adolescents (N = 157) aged 13-17 completed the Trier Social Stress Test (TSST). Affective, cognitive, and physiological responses were obtained before, during, and after the TSST. Adolescents who engaged in habitual rumination experienced greater negative affect and more negative cognitive appraisals in response to the TSST than adolescents with lower levels of rumination. Rumination was unrelated to heart rate reactivity, but predicted slower heart rate recovery from the TSST, indicating that rumination might be specifically associated with physiological recovery from stress. Rumination is associated with negative affective, cognitive, and physiological responses following stressors, suggesting potential mechanisms through which it might increase risk for psychopathology.

The treatment of human cancer with agents prepared from bovine cartilage.

PubMed

Prudden, J F

1985-12-01

Oral and subcutaneous administration of specific preparations of bovine tracheal cartilage rings (Catrix), a nontoxic agent, has resulted in a high response rate in 31 cases of a variety of clinical malignancies (response rate 90%, 61% complete). The demonstrated responder include present therapeutic disasters such as glioblastoma multiforme and cancers of the pancreas and lung. Other types which were treated with success included cancers of the ovary, rectum, prostate, cervix, thyroid, and an inoperable squamous cancer of the nose. These responses were observed when full dose therapy was given over prolonged courses of treatment (years). This wide range of Catrix efficacy now invites investigation by others to confirm the effectiveness of the material and to isolate the molecular entities responsible for these unexpectedly favorable results.

Rates, Delays, and Completeness of General Practitioners' Responses to a Postal Versus Web-Based Survey: A Randomized Trial.

PubMed

Sebo, Paul; Maisonneuve, Hubert; Cerutti, Bernard; Fournier, Jean Pascal; Senn, Nicolas; Haller, Dagmar M

2017-03-22

Web-based surveys have become a new and popular method for collecting data, but only a few studies have directly compared postal and Web-based surveys among physicians, and none to our knowledge among general practitioners (GPs). Our aim is to compare two modes of survey delivery (postal and Web-based) in terms of participation rates, response times, and completeness of questionnaires in a study assessing GPs' preventive practices. This randomized study was conducted in Western Switzerland (Geneva and Vaud) and in France (Alsace and Pays de la Loire) in 2015. A random selection of community-based GPs (1000 GPs in Switzerland and 2400 GPs in France) were randomly allocated to receive a questionnaire about preventive care activities either by post (n=700 in Switzerland, n=400 in France) or by email (n=300 in Switzerland, n=2000 in France). Reminder messages were sent once in the postal group and twice in the Web-based group. Any GPs practicing only complementary and alternative medicine were excluded from the study. Among the 3400 contacted GPs, 764 (22.47%, 95% CI 21.07%-23.87%) returned the questionnaire. Compared to the postal group, the participation rate in the Web-based group was more than four times lower (246/2300, 10.70% vs 518/1100, 47.09%, P<.001), but median response time was much shorter (1 day vs 1-3 weeks, P<.001) and the number of GPs having fully completed the questionnaire was almost twice as high (157/246, 63.8% vs 179/518, 34.6%, P<.001). Web-based surveys offer many advantages such as reduced response time, higher completeness of data, and large cost savings, but our findings suggest that postal surveys can be still considered for GP research. The use of mixed-mode approaches is probably a good strategy to increase GPs' participation in surveys while reducing costs. ©Paul Sebo, Hubert Maisonneuve, Bernard Cerutti, Jean Pascal Fournier, Nicolas Senn, Dagmar M Haller. Originally published in the Journal of Medical Internet Research (http://www.jmir.org), 22.03.2017.

Sustainability of the prevention of passive infant smoking within well-baby clinics.

PubMed

Crone, M R; Verlaan, M; Willemsen, M C; van Soelen, P; Reijneveld, S A; Sing, R A Hira; Paulussen, T G W M

2006-04-01

This study assessed the antecedents of continued use of an education program to prevent passive smoking in infants. It consists of a booklet for parents and a manual for health professionals describing a five-step procedure for discussing passive smoking. A questionnaire was sent to 67 managers, 670 nurses, and 335 physicians working in well-baby clinics (response rate: 70%, 53%, 47% respectively). Questions concerned the completeness of use, level of institutionalization, and characteristics of the organization, the user, and the dissemination strategy. Seventy-one percent of nurses and 42% of physicians worked with the program. They foremost provided the first three steps of the five-step procedure. Physicians' completeness of use was related to their perceived responsibility in providing this education, and nurses' use was related to their perceived self-efficacy, responsibility, training attendance, participation in the adoption decision, and level of institutionalization. Diffusion efforts should focus on improving the completeness of use and level of institutionalization.

The Effects of Focused Attention on Inhibition and State Regulation in Children with and without Attention Deficit Hyperactivity Disorder

ERIC Educational Resources Information Center

Ketch, Karen M.; Brodeur, Darlene A.; McGee, Robin

2009-01-01

This study investigated the effects of response rate and attention focusing on performance of ADHD, clinical-control (CRNA) and non-clinical control children in response inhibition tasks. All children completed the "Go-NoGo" task, a computer-based task of attention and impulsivity. Focused attention on this task was manipulated using a priming…

Survey of Micro Enterprise.

ERIC Educational Resources Information Center

European Social Fund, Dublin (Ireland).

Government support of microenterprise/entrepreneurship in Ireland was examined through structured interviews with 81 of 120 microentrepreneurs (68% response rate) identified as clients of local enterprise support agencies and/or completers of enterprise training and structured interviews with representatives of 25 local, voluntary, and private…

Immune interference in the setting of same-day administration of two similar inactivated alphavirus vaccines: eastern equine and western equine encephalitis.

PubMed

Reisler, Ronald B; Gibbs, Paul H; Danner, Denise K; Boudreau, Ellen F

2012-11-26

We compared the effect on primary vaccination plaque-reduction neutralization 80% titers (PRNT80) responses of same-day administration (at different injection sites) of two similar investigational inactivated alphavirus vaccines, eastern equine encephalitis (EEE) vaccine (TSI-GSD 104) and western equine encephalitis (WEE) vaccine (TSI-GSD 210) to separate administration. Overall, primary response rate for EEE vaccine was 524/796 (66%) and overall primary response rate for WEE vaccine was 291/695 (42%). EEE vaccine same-day administration yielded a 59% response rate and a responder geometric mean titer (GMT)=89 while separate administration yielded a response rate of 69% and a responder GMT=119. WEE vaccine same-day administration yielded a 30% response rate and a responder GMT=53 while separate administration yielded a response rate of 54% and a responder GMT=79. EEE response rates for same-day administration (group A) vs. non-same-day administration (group B) were significantly affected by gender. A logistic regression model predicting response to EEE comparing group B to group A for females yielded an OR=4.10 (95% CL 1.97-8.55; p=.0002) and for males yielded an OR=1.25 (95% CL 0.76-2.07; p=.3768). WEE response rates for same-day administration vs. non-same-day administration were independent of gender. A logistic regression model predicting response to WEE comparing group B to group A yielded an OR=2.14 (95% CL 1.22-3.73; p=.0077). We report immune interference occurring with same-day administration of two completely separate formalin inactivated viral vaccines in humans. These findings combined with the findings of others regarding immune interference would argue for a renewed emphasis on studying the immunological mechanisms of induction of inactivated viral vaccine protection. Copyright © 2012. Published by Elsevier Ltd.

Topical methyl-aminolevulinate photodynamic therapy using red light-emitting diode light for treatment of multiple actinic keratoses: A randomized, double-blind, placebo-controlled study.

PubMed

Pariser, David; Loss, Robert; Jarratt, Michael; Abramovits, William; Spencer, James; Geronemus, Roy; Bailin, Philip; Bruce, Suzanne

2008-10-01

The use of light-emitting diode light offers practical advantages in photodynamic therapy (PDT) with topical methyl-aminolevulinate (MAL) for management of actinic keratoses (AK). We sought to evaluate the efficacy of MAL PDT using red light-emitting diode light. We conducted a multicenter, double-blind, randomized study. A total of 49 patients with 363 AK lesions had 16.8% MAL cream applied under occlusion for 3 hours, and 47 patients with 360 AK lesions had vehicle cream similarly applied. The lesions were then illuminated (630 nm, light dose 37 J/cm2) with repeated treatment 1 week later. Complete lesion and patient (all lesions showing complete response) response rates were evaluated 3 months after last treatment. MAL PDT was superior (P<.0001) to vehicle PDT with respect to lesion complete response (86.2% vs 52.2%, odds ratio 6.9 [95% confidence interval 4.7-10.3]) and patient complete response (59.2% vs 14.9%, odds ratio 13.2 [95% confidence interval 4.1-43.1]). The study population may not be representative of all patients with AK. MAL PDT using red light-emitting diode light is an appropriate treatment alternative for multiple AK lesions.

Predictors of web-based follow-up response in the Prevention of Low Back Pain in the Military Trial (POLM)

PubMed Central

2011-01-01

Background Achieving adequate follow-up in clinical trials is essential to establish the validity of the findings. Achieving adequate response rates reduces bias and increases probability that the findings can be generalized to the population of interest. Therefore, the purpose of this study was to determine the influence of attention, demographic, psychological, and health status factors on web-based response rates in the ongoing Prevention of Low Back Pain in the Military (POLM) trial. Methods Twenty companies of Soldiers (n = 4,325) were cluster randomized to complete a traditional exercise program including sit-ups (TEP) with or without a psychosocial educational program (PSEP) or a core stabilization exercise program (CSEP) with or without PSEP. A subgroup of Soldiers (n = 371) was randomized to receive an additional physical and ultrasound imaging (USI) examination of key trunk musculature. As part of the surveillance program, all Soldiers were encouraged to complete monthly surveys via email during the first year. Descriptive statistics of the predictor variables were obtained and compared between responders and non-responders using two sample t-tests or chi-square test, as appropriate. Generalized linear mixed models were subsequently fitted for the dichotomous outcomes to estimate the effects of the predictor variables. The significance level was set at .05 a priori. Results The overall response rate was 18.9% (811 subjects) for the first year. Responders were more likely to be older, Caucasian, have higher levels of education and income, reservist military status, non smoker, lower BMI, and have received individualized attention via the physical/USI examination (p < .05). Age, race/ethnicity, education, military status, smoking history, BMI, and whether a Soldier received the physical/USI examination remained statistically significant (p < .05) when considered in a full multivariate model. Conclusion The overall web based response rate during the first year of the POLM trial was consistent with studies that used similar methodology, but lower when compared to rates expected for standard clinical trials. One year response rate was significantly associated with demographic characteristics, health status, and individualized attention via additional testing. These data may assist for planning of future trials that use web based response systems. Trial Registration This study has been registered at reports at http://clinicaltrials.gov (NCT00373009). PMID:21668961

Symptomatic improvement reported after receiving Reiki at a cancer infusion center.

PubMed

Marcus, Dawn A; Blazek-O'Neill, Betsy; Kopar, Jennifer L

2013-03-01

To evaluate patient-perceived benefits from receiving Reiki at a cancer infusion center. During a 6-month period, adults at a university hospital receiving Reiki through volunteer services were invited to complete a survey asking about perceived changes after Reiki. Changes in pain, mood, distress, sleep, and appetite were rated on a 5-point scale from no benefit to great benefit. Surveys were distributed after completing treatment and were returned in postage-paid envelops. A total of 145 surveys were completed (34.5% response rate), with 47 participants seen in the cancer infusion center and 98 in other areas of the hospital. Reiki was rated as a positive experience by 94% at the cancer center and 93% of others, with 92% at the cancer center and 86% of others interested in receiving additional Reiki sessions. Symptomatic improvement was similar for people at the cancer center and others, respectively, with much to great improvement for 89% and 86% for relaxation, 75% and 75% for anxiety/worry, 81% and 78% for improved mood, 43% and 35% for improved sleep, 45% and 49% for reduced pain, 38% and 43% for reduced isolation/loneliness, 75% and 63% for improved attitude, and 30% and 30% for improved appetite. Response was unaffected by previous exposure to Reiki, massage, or other touch therapy. Reiki results in a broad range of symptomatic benefits, including improvements in common cancer-related symptoms.

Perceptions of wellness to monitor adaptive responses to training and competition in elite Australian football.

PubMed

Gastin, Paul B; Meyer, Denny; Robinson, Dean

2013-09-01

Perceptions of wellness are often used by athletes and coaches to assess adaptive responses to training. The purpose of this research was to describe how players were coping with the demands of elite level Australian football over a competitive season using subjective ratings of physical and psychological wellness and to assess the ecological validity of such a monitoring approach. Twenty-seven players completed ratings for 9 items (fatigue, general muscle, hamstring, quadriceps, pain/stiffness, power, sleep quality, stress, well-being). Players subjectively rated each item as they arrived at the training or competition venue on a 1-5 visual analog scale, with 1 representing the positive end of the continuum. A total of 2,583 questionnaires were analyzed from completions on 183 days throughout the season (92 ± 24 per player, 103 ± 20 per week; mean ± SD). Descriptive statistics and multilevel modelling were used to understand how player ratings of wellness varied over the season and during the week leading into game day and whether selected player characteristics moderated these relationships. Results indicated that subjective ratings of physical and psychological wellness were sensitive to weekly training manipulations (i.e., improve steadily throughout the week to a game day low, p < 0.001), to periods of unloading during the season (i.e., a week of no competition, p < 0.05) and to individual player characteristics (e.g., muscle strain after a game was poorer in players with high maximum speed, p < 0.01). It is concluded that self-reported player ratings of wellness provide a useful tool for coaches and practitioners to monitor player responses to the rigorous demands of training, competition, and life as a professional athlete.

Recurrence of vulval intraepithelial neoplasia following treatment with cidofovir or imiquimod: results from a multicentre, randomised, phase II trial (RT3VIN).

PubMed

Hurt, C N; Jones, Sef; Madden, T-A; Fiander, A; Nordin, A J; Naik, R; Powell, N; Carucci, M; Tristram, A

2018-01-16

To compare the recurrence rates after complete response to topical treatment with either cidofovir or imiquimod for vulval intraepithelial neoplasia (VIN) 3. A prospective, open, randomised multicentre trial. 32 general hospitals located in Wales and England. 180 patients were randomised consecutively between 21 October 2009 and 11 January 2013, 89 to cidofoovir (of whom 41 completely responded to treatment) and 91 to imiquimod (of whom 42 completely responded to treatment). After 24 weeks of treatment, complete responders were followed up at 6-monthly intervals for 24 months. At each visit, the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 was assessed and any new lesions were biopsied for histology. Time to histologically confirmed disease recurrence (any grade of VIN). The median length of follow up was 18.4 months. At 18 months, more participants were VIN-free in the cidofovir arm: 94% (95% CI 78.2-98.5) versus 71.6% (95% CI 52.0-84.3) [univariable hazard ratio (HR) 3.46, 95% CI 0.95-12.60, P = 0.059; multivariable HR 3.53, 95% CI 0.96-12.98, P = 0.057). The number of grade 2+ events was similar between treatment arms (imiquimod: 24/42 (57%) versus cidofovir: 27/41 (66%), χ2 = 0.665, P = 0.415), with no grade 4+. Long-term data indicates a trend towards response being maintained for longer following treatment with cidofovir than with imiquimod, with similar low rates of adverse events for each drug. Adverse event rates indicated acceptable safety of both drugs TWEETABLE ABSTRACT: Long-term follow up in the RT3VIN trial suggests cidofovir may maintain response for longer than imiquimod. © 2018 The Authors. BJOG: An International Journal of Obstetrics and Gynaecology published by John Wiley & Sons Ltd on behalf of Royal College of Obstetricians and Gynaecologists.

Vaccination against hepatitis A and B in persons subject to homelessness in inner Sydney: vaccine acceptance, completion rates and immunogenicity.

PubMed

Poulos, Roslyn G; Ferson, Mark J; Orr, Karen J; McCarthy, Michele A; Botham, Susan J; Stern, Jerome M; Lucey, Adrienne

2010-04-01

To determine acceptance, completion rates and immunogenicity of the standard vaccination schedule for hepatitis A (HAV) and B (HBV) in persons subject to homelessness. A convenience sample of clients (n=201) attending a medical clinic for homeless and disadvantaged persons in Sydney was enrolled. Serological screening for HAV and HBV was undertaken. An appropriate vaccination program was instituted. Post-vaccination serology determined serological response. Although many clients had serological evidence of past infection, at least 138 (69%) clients had the potential to benefit from vaccination. For hepatitis A and B vaccinations, completion rates were 73% (73 of 100 clients) and 75% (69 of 92 clients), respectively; after vaccination, protective antibody was found in 98.2% (56 of 57) and 72% (36 of 50) of clients, respectively. A successful vaccination program can be mounted with a vulnerable population. We consider a clinic with a well-established history of acceptance and utilisation by the target group; a low staff turnover and regular clientele; inclusion of vaccination as part of routine client care; and counselling (part of pre- and post-serological testing) essential components in achieving good vaccination completion rates. © 2010 The Authors. Journal Compilation © 2010 Public Health Association of Australia.

Biochemotherapy in patients with advanced head and neck mucosal melanoma.

PubMed

Bartell, Holly L; Bedikian, Agop Y; Papadopoulos, Nicholas E; Dett, Tina K; Ballo, Matthew T; Myers, Jeffrey N; Hwu, Patrick; Kim, Kevin B

2008-12-01

No systemic therapy regimen has been recognized as effective for metastatic mucosal melanoma of the head and neck. We retrospectively analyzed the effectiveness of biochemotherapy in patients with advanced head and neck mucosal melanoma. We evaluated the medical records of 15 patients at our institution who had received various biochemotherapy regimens for advanced head and neck mucosal melanoma. After a median follow-up duration of 13 months, 3 patients (20%) had partial response, and 4 patients (27%) had complete response. The median time to disease progression for all 15 patients was 10 months. The median overall survival duration for all patients was 22 months. Although this was a small study, our results, especially the high complete response and overall response rates, indicate that biochemotherapy for advanced head and neck mucosal melanoma should be considered as a systemic treatment option for patients with this aggressive malignancy.

Modern Outcomes of Inflammatory Breast Cancer

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

Rehman, Sana; Northeast Ohio Medical University, Rootstown, Ohio; Reddy, Chandana A.

2012-11-01

Purpose: To report contemporary outcomes for inflammatory breast cancer (IBC) patients treated in the modern era of trastuzumab and taxane-based chemotherapy. Methods and Materials: We retrospectively reviewed the charts of 104 patients with nonmetastatic IBC treated between January 2000 and December 2009. Patients who received chemotherapy, surgery, and radiation therapy were considered to have completed the intended therapy. Kaplan-Meier curves estimated locoregional control (LRC), distant metastases-free survival (DMFS), and overall survival. Results: The median follow-up time was 34 months; 57 (55%) patients were estrogen receptor progesterone receptor (ER/PR) negative, 34 (33%) patients were human epidermal growth factor receptor 2 (her2)/neumore » amplified, and 78 (75%) received definitive postoperative radiation. Seventy-five (72%) patients completed all of the intended therapy, of whom 67 (89%) received a taxane and 18/28 (64%) of her2/neu-amplified patients received trastuzumab. For the entire cohort, the 5-year rates of overall survival, LRC, and DMFS were 46%, 83%, and 44%, respectively. The ER/PR-negative patients had a 5-year DMFS of 39% vs. 52% for ER/PR-positive patients (p = 0.03). The 5-year DMFS for patients who achieved a pathologic complete response compared with those who did not was 83% vs. 44% (p < 0.01). Those patients who received >60.4 Gy (n = 15) to the chest wall had a 5-year LRC rate of 100% vs. 83% for those who received 45 to 60.4 Gy (n = 49; p = 0.048). On univariate analysis, significant predictors of DMFS included achieving a complete response to neoadjuvant chemotherapy (hazard ratio [HR] = 5.8; 95% confidence interval [CI] = 1.4-24.4; p = 0.02) and pathologically negative lymph nodes (HR = 4.1; 95% CI = 1.4-11.9; p < 0.01), but no factor was significant on multivariate analysis. Conclusions: For IBC patients, the rate of distant metastases is still high despite excellent local control, particularly for patients who received >60.4 Gy to the chest wall. Despite the use of taxanes and trastuzumab, outcomes remain modest, particularly for those with ER/PR-negative disease and those without a pathologic complete response.« less

Randomized, double-blind, placebo-controlled trial of fluoxetine treatment for elderly patients with dysthymic disorder.

PubMed

Devanand, D P; Nobler, Mitchell S; Cheng, Jocelyn; Turret, Nancy; Pelton, Gregory H; Roose, Steven P; Sackeim, Harold A

2005-01-01

The authors compared the efficacy and side effects of fluoxetine and placebo in elderly outpatients with dysthymic disorder. Patients were randomly assigned to fluoxetine (20 mg-60 mg/day) or placebo for 12 weeks in a double-blind trial. Of 90 randomized patients, 71 completed the trial. In the intent-to-treat sample, random regression analyses of the Hamilton Rating Scale for Depression (Ham-D; 24-item) and Cornell Dysthymia Rating Scale (CDRS) scores at each visit produced significant time x treatment group interactions favoring the fluoxetine group. Analysis of percentage change in Ham-D scores yielded no effect for treatment group, but a similar analysis of percentage change in CDRS scores yielded a main effect for treatment group, favoring fluoxetine over placebo. In the intent-to-treat sample, response rates were 27.3% for fluoxetine and 19.6% for placebo. In the completer sample, response rates were 37.5% for fluoxetine and 23.1% for placebo. Fluoxetine had limited efficacy in elderly dysthymic patients. The clinical features of elderly dysthymic patients are typically distinct from those of dysthymic disorder in young adults, and the findings suggest that treatments effective for young adult dysthymic patients may not be as useful in elderly dysthymic patients. Further research is needed to identify efficacious treatments for elderly patients with dysthymic disorder, and investigative tools such as electronic/computerized brain scans and neuropsychological testing may help identify the factors that moderate antidepressant treatment response and resistance.

Young women's food preferences and taste responsiveness to 6-n-propylthiouracil (PROP).

PubMed

Kaminski, L C; Henderson, S A; Drewnowski, A

2000-03-01

This study examined links between taste responsiveness to 6-n-propylthiouracil (PROP), a heritable trait, and sensory responses to six common foods. Sixty-three young women subjects were divided into PROP tasters (n = 25) and nontasters (n = 25), based on their responses to PROP-impregnated filter paper and mean bitterness intensity ratings for seven PROP solutions. Thirteen subjects were excluded as unclassifiable. The 50 subjects sampled Brussels sprouts, broccoli, spinach, black coffee, soy milk, and soybean tofu. Sensory ratings for bitter intensity; pleasantness of taste, odor, and texture, and overall food acceptability scores were obtained using nine-point category scales. All subjects completed a food-preference checklist and a modified food-frequency questionnaire. PROP tasters rated Brussels sprouts as more bitter than did nontasters (p<0.05). Subjects who perceived the foods as more bitter also rated them as less pleasant and less acceptable. Taste preferences and food preferences were linked. Self-reported food preferences and self-reported frequencies of consumption for the same foods were also linked. Taste factors and food preferences may impact dietary choices and the frequency of food consumption.

Phase II study of mitoguazone, cyclophosphamide, doxorubicin, vincristine and prednisone for patients with diffuse histologic subtypes of non-Hodgkin's lymphoma: an Eastern Cooperative Oncology Group Study (PE481).

PubMed

Wiernik, P H; Moore, D F; Bennett, J M; Vogl, S E; Harris, J E; Luger, S; Oken, M M; Glick, J H

1998-08-01

Mitoguazone, an investigational agent with significant activity in advanced lymphoma, was added to a modified CHOP regimen (COPA) in an effort to improve the activity of standard therapy in 66 previously untreated patients with stages II-IV lymphoma and diffuse histology of intermediate or high grade other than lymphoblastic in this phase II pilot study. The regimen was well tolerated and the complete response rate in diffuse large cell lymphoma was 55%. Sixty-five percent of all complete responders were in complete response for at least one year. Despite these excellent results. it is unlikely that the addition of mitoguazone improved results compared with those obtained with standard therapy alone, since similar results have been frequently reported with the latter.

Review of immunomodulation by photopheresis: treatment of cutaneous T-cell lymphoma, autoimmune disease, and allograft rejection.

PubMed

Wolfe, J T; Lessin, S R; Singh, A H; Rook, A H

1994-12-01

Photopheresis is an apheresis-based therapy that is currently available at approximately 70 medical centers worldwide. Recent evidence indicates that extracorporeal photopheresis can significantly prolong life as well as induce a 60-75% response rate among individuals with advanced cutaneous T-cell lymphoma (CTCL). Moreover, a 10-15% cure rate, in response to photopheresis alone, or in combination with interferon-alpha, has been obtained at our institution. These complete responses have been characterized by the complete disappearance of morphologically atypical cells from the skin and blood. Southern blot analysis of peripheral blood specimens has also confirmed the indefinite disappearance of the malignant T-cell clone from the blood of patients with complete responses. Current immunological data obtained from in vitro human studies and from animal models suggest that the basis for the responses of CTCL patients are related to activation of treated macrophages resulting in release of cytokines, including substantial levels of tumor necrosis factor alpha (TNF-alpha), and perhaps, to the induction of anticlonotypic immunity directed against pathogenic clones of T lymphocytes. In addition to the treatment of CTCL, a potential role for photopheresis in the therapy of autoimmune disease has been suggested by recent pilot studies of pemphigus vulgaris, rheumatoid arthritis, and systemic lupus erythematosus. Furthermore, a randomized, single-blinded trial involving 79 patients with early onset, aggressive systemic sclerosis suggested that photopheresis could benefically affect the course of the cutaneous thickening in this form of the disease. Lastly, two independent pilot studies of cardiac transplantation have indicated that photopheresis can reverse acute cardiac allograft rejection and potentially suppress ongoing chronic rejection. Randomized, controlled trials for these new indications for photopheresis therapy are currently in the early stages of implementation.

Phase II Trial of Full-Dose Gemcitabine and Bevacizumab in Combination With Attenuated Three-Dimensional Conformal Radiotherapy in Patients With Localized Pancreatic Cancer

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

Small, William, E-mail: wsmall@nmff.or; Mulcahy, Mary F.; Rademaker, Alfred

Purpose: To evaluate response rate, survival, and toxicity in patients with nonmetastatic pancreatic cancer treated with gemcitabine, bevacizumab, and radiotherapy. Methods and Materials: Patients received three cycles of therapy over 10 weeks. In total, treatment consisted of intravenous (IV) gemcitabine, 1,000 mg/m{sup 2}, every 1 to 2 weeks (7 doses), IV bevacizumab, 10 mg/kg every 2 weeks (5 doses), and 36 Gy of radiotherapy (2.4-Gy fractions during cycle two). Response was assessed by cross-sectional imaging and carbohydrate antigen 19-9 (CA 19-9) levels. Patients with resectable tumors underwent surgery 6 to 8 weeks after the last dose of bevacizumab. Maintenance gemcitabinemore » and bevacizumab doses were delivered to patients who had unresected tumors and no progression. Results: Twenty-eight of the 32 enrolled patients completed all three cycles. The median follow-up was 11.07 months. Most grade 3 or 4 toxicities occurred in the initial treatment phase; the most frequent toxicities were leukopenia (21%), neutropenia (17%), and nausea (17%). At week 10, 1 patient (4%) had a complete response, 2 patients (7%) had partial responses, 21 patients (75%) had stable disease, and 4 patients (14%) had progressive disease. The median pretreatment and posttreatment CA 19-9 levels (25 patients) were 184.3 and 57.9 U/ml, respectively (p = 0.0006). One of 10 patients proceeding to surgery experienced a major complication. Two of 6 patients undergoing resection had complete pathologic responses. The median progression-free and overall survival durations were 9.9 months and 11.8 months, respectively. Conclusions: The combination of full-dose gemcitabine, bevacizumab, and radiotherapy was active and was not associated with a high rate of major surgical complications.« less

Results of telerobotic hand controller study using force information and rate control

NASA Technical Reports Server (NTRS)

Willshire, Kelli F.; Harrison, F. W.; Hogge, Edward F.; Williams, Robert L.; Soloway, Donald

1992-01-01

To increase quantified information about the effectiveness and subjective workload of force information relayed through manipulator input control devices, a space related task was performed by eight subjects with kinesthetic force feedback and/or local force accommodation through three different input control devices (i.e., hand controllers) operating in rate control mode. Task completion time, manipulator work, and subjective responses were measured. Results indicated a difference among the hand controllers. For the Honeywell six degree-of-freedom hand controller, the overall task completion times were shortest, the amount of work exerted was the least, and was the most preferred by test subjects. Neither force accommodation with or without reflection resulted in shorter task completion times or reduced work although those conditions were better than no force information for some aspects. Comparisons of results from previous studies are discussed.

A Single-Center Experience With Isolated Limb Infusion: An Interventional Oncology Opportunity.

PubMed

DeFoe, Adam; Heckman, Andrew; Slater, Dick; Silva-Lopez, Edibaldo; Foster, Jason; Bowden, Thom; Vargo, Christopher

2017-03-01

This retrospective review details our experience with isolated limb infusion for the treatment of melanoma, squamous cell carcinoma, and sarcoma in-transit metastases performed entirely in the interventional radiology suite. Eleven patients were treated over a 3-year period. Treatment response was assessed clinically and with PET/CT. Eight patients had either complete or partial response, giving an overall response rate of 72%. Isolated limb infusion can efficiently be performed entirely in the interventional radiology suite.

Determining the minimal clinically important difference and responsiveness of the Dermatology Life Quality Index (DLQI): further data.

PubMed

Basra, M K A; Salek, M S; Camilleri, L; Sturkey, R; Finlay, A Y

2015-01-01

To determine the minimal clinically important difference (MCID) of the Dermatology Life Quality Index (DLQI) and its responsiveness to change in inflammatory skin diseases. A longitudinal study: at stage 1, patients completed the DLQI and a disease severity global question; at stage 2, a global rating of change in quality of life (QoL; Global Rating of Change Questionnaire, GRCQ) was added and used as an anchor to measure the MCID of the DLQI. 192 patients completed stage 1 and 107 completed stage 2. The mean DLQI score at stage 1 was 9.8 and 7.4 at stage 2 with a mean change of 2.4 (p < 0.0001). 31 patients experienced a 'small change' in their QoL (±3 and ±2) on the GRCQ. The mean corresponding change in DLQI scores was 3.3, which is regarded as the approximate MCID. Previous estimates of the MCID of the DLQI have varied from 3 to 5. Although this study demonstrated a MCID of 3.3, we recommend that the MCID in inflammatory skin diseases should be 4. © 2015 S. Karger AG, Basel.

Infliximab Versus Adalimumab in the Treatment of Refractory Inflammatory Uveitis: A Multicenter Study From the French Uveitis Network.

PubMed

Vallet, Hélène; Seve, Pascal; Biard, Lucie; Baptiste Fraison, Jean; Bielefeld, Philip; Perard, Laurent; Bienvenu, Boris; Abad, Sébastien; Rigolet, Aude; Deroux, Alban; Sene, Damien; Perlat, Antoinette; Marie, Isabelle; Feurer, Elodie; Hachulla, Eric; Fain, Olivier; Clavel, Gaëlle; Riviere, Sophie; Bouche, Pierre-Alban; Gueudry, Julie; Pugnet, Gregory; Le Hoang, Phuc; Resche Rigon, Matthieu; Cacoub, Patrice; Bodaghi, Bahram; Saadoun, David

2016-06-01

To analyze the factors associated with response to anti-tumor necrosis factor (anti-TNF) treatment and compare the efficacy and safety of infliximab (IFX) and adalimumab (ADA) in patients with refractory noninfectious uveitis. This was a multicenter observational study of 160 patients (39% men and 61% women; median age 31 years [interquartile range 21-42]) with uveitis that had been refractory to other therapies, who were treated with anti-TNF (IFX 5 mg/kg at weeks 0, 2, 6, and then every 5-6 weeks [n = 98] or ADA 40 mg every 2 weeks [n = 62]). Factors associated with complete response were assessed by multivariate analysis. Efficacy and safety of IFX versus ADA were compared using a propensity score approach with baseline characteristics taken into account. Subdistribution hazard ratios (SHRs) and 95% confidence intervals (95% CIs) were calculated. The main etiologies of uveitis included Behçet's disease (BD) (36%), juvenile idiopathic arthritis (22%), spondyloarthropathy (10%), and sarcoidosis (6%). The overall response rate at 6 and 12 months was 87% (26% with complete response) and 93% (28% with complete response), respectively. The median time to complete response was 2 months. In multivariate analysis, BD and occurrence of >5 uveitis flares before anti-TNF initiation were associated with complete response to anti-TNF (SHR 2.52 [95% CI 1.35-4.71], P = 0.004 and SHR 1.97 [95% CI 1.02-3.84], P = 0.045, respectively). Side effects were reported in 28% of patients, including serious adverse events in 13%. IFX and ADA did not differ significantly in terms of occurrence of complete response (SHR 0.65 [95% CI 0.25-1.71], P = 0.39), serious side effects (SHR 0.22 [95% CI 0.04-1.25], P = 0.089), or event-free survival (SHR 0.55 [95% CI 0.28-1.08], P = 0.083). Anti-TNF treatment is highly effective in refractory inflammatory uveitis. BD is associated with increased odds of response. IFX and ADA appear to be equivalent in terms of efficacy. © 2016, American College of Rheumatology.

Effect of manipulating recombination rates on response to selection in livestock breeding programs.

PubMed

Battagin, Mara; Gorjanc, Gregor; Faux, Anne-Michelle; Johnston, Susan E; Hickey, John M

2016-06-22

In this work, we performed simulations to explore the potential of manipulating recombination rates to increase response to selection in livestock breeding programs. We carried out ten replicates of several scenarios that followed a common overall structure but differed in the average rate of recombination along the genome (expressed as the length of a chromosome in Morgan), the genetic architecture of the trait under selection, and the selection intensity under truncation selection (expressed as the proportion of males selected). Recombination rates were defined by simulating nine different chromosome lengths: 0.10, 0.25, 0.50, 1, 2, 5, 10, 15 and 20 Morgan, respectively. One Morgan was considered to be the typical chromosome length for current livestock species. The genetic architecture was defined by the number of quantitative trait variants (QTV) that affected the trait under selection. Either a large (10,000) or a small (1000 or 500) number of QTV was simulated. Finally, the proportions of males selected under truncation selection as sires for the next generation were equal to 1.2, 2.4, 5, or 10 %. Increasing recombination rate increased the overall response to selection and decreased the loss of genetic variance. The difference in cumulative response between low and high recombination rates increased over generations. At low recombination rates, cumulative response to selection tended to asymptote sooner and the genetic variance was completely eroded. If the trait under selection was affected by few QTV, differences between low and high recombination rates still existed, but the selection limit was reached at all rates of recombination. Higher recombination rates can enhance the efficiency of breeding programs to turn genetic variation into response to selection. However, to increase response to selection significantly, the recombination rate would need to be increased 10- or 20-fold. The biological feasibility and consequences of such large increases in recombination rates are unknown.

PARENTAL ALLERGY TO FARM ALLERGENS NAD ALLERGIC ILLNESSES IN CHILDREN

EPA Science Inventory

Recent literature has reported low asthma and/or atopy prevalence or associated symptoms in rural/agricultural populations. We found relatively high rates of childhood asthma (16%), atopy (36%), and bronchial hyper-responsiveness (BHR) (45%) in a completely rural cohort. The high...

Predictors of locating women six to eight years after contact: internet resources at recruitment may help to improve response rates in longitudinal research

PubMed Central

Cadarette, Suzanne M; Dickson, Leigh; Gignac, Monique AM; Beaton, Dorcas E; Jaglal, Susan B; Hawker, Gillian A

2007-01-01

Background The ability to locate those sampled has important implications for response rates and thus the success of survey research. The purpose of this study was to examine predictors of locating women requiring tracing using publicly available methods (primarily Internet searches), and to determine the additional benefit of vital statistics linkages. Methods Random samples of women aged 65–89 years residing in two regions of Ontario, Canada were selected from a list of those who completed a questionnaire between 1995 and 1997 (n = 1,500). A random sample of 507 of these women had been searched on the Internet as part of a feasibility pilot in 2001. All 1,500 women sampled were mailed a newsletter and information letter prior to recruitment by telephone in 2003 and 2004. Those with returned mail or incorrect telephone number(s) required tracing. Predictors of locating women were examined using logistic regression. Results Tracing was required for 372 (25%) of the women sampled, and of these, 181 (49%) were located. Predictors of locating women were: younger age, residing in less densely populated areas, having had a web-search completed in 2001, and listed name identified on the Internet prior to recruitment in 2003. Although vital statistics linkages to death records subsequently identified 41 subjects, these data were incomplete. Conclusion Prospective studies may benefit from using Internet resources at recruitment to determine the listed names for telephone numbers thereby facilitating follow-up tracing and improving response rates. Although vital statistics linkages may help to identify deceased individuals, these may be best suited for post hoc response rate adjustment. PMID:17577404

Predictors of locating women six to eight years after contact: internet resources at recruitment may help to improve response rates in longitudinal research.

PubMed

Cadarette, Suzanne M; Dickson, Leigh; Gignac, Monique A M; Beaton, Dorcas E; Jaglal, Susan B; Hawker, Gillian A

2007-06-18

The ability to locate those sampled has important implications for response rates and thus the success of survey research. The purpose of this study was to examine predictors of locating women requiring tracing using publicly available methods (primarily Internet searches), and to determine the additional benefit of vital statistics linkages. Random samples of women aged 65-89 years residing in two regions of Ontario, Canada were selected from a list of those who completed a questionnaire between 1995 and 1997 (n = 1,500). A random sample of 507 of these women had been searched on the Internet as part of a feasibility pilot in 2001. All 1,500 women sampled were mailed a newsletter and information letter prior to recruitment by telephone in 2003 and 2004. Those with returned mail or incorrect telephone number(s) required tracing. Predictors of locating women were examined using logistic regression. Tracing was required for 372 (25%) of the women sampled, and of these, 181 (49%) were located. Predictors of locating women were: younger age, residing in less densely populated areas, having had a web-search completed in 2001, and listed name identified on the Internet prior to recruitment in 2003. Although vital statistics linkages to death records subsequently identified 41 subjects, these data were incomplete. Prospective studies may benefit from using Internet resources at recruitment to determine the listed names for telephone numbers thereby facilitating follow-up tracing and improving response rates. Although vital statistics linkages may help to identify deceased individuals, these may be best suited for post hoc response rate adjustment.

Compliance With Neuromuscular Training and Anterior Cruciate Ligament Injury Risk Reduction in Female Athletes: A Meta-Analysis

PubMed Central

Sugimoto, Dai; Myer, Gregory D.; Bush, Heather M.; Klugman, Maddie F.; McKeon, Jennifer M. Medina; Hewett, Timothy E.

2012-01-01

Context No consensus exists about the influence of compliance with neuromuscular training programs on reduction of the risk of anterior cruciate ligament (ACL) injury. Objective To systematically review and synthesize the published literature to determine if compliance with neuromuscular training is associated with reduced incidence of ACL injury in young female athletes. Data Sources We searched PubMed, SPORTDiscus, CINAHL, and MEDLINE for articles published from 1995 to 2010 using the key words anterior cruciate ligament prevention, ACL prevention, knee prevention, prospective knee prevention, neuromuscular training, and neuromuscular intervention. Study Selection Criteria for inclusion required that (1) the number of ACL injuries was reported, (2) a neuromuscular training program was used, (3) females were included as participants, (4) the study design was prospective and controlled, and (5) compliance data for the neuromuscular training program were provided. Data Extraction Extracted data included the number of ACL injuries, total number of participants per group, observation time period, number of participants who completed each session, number of sessions completed by an entire team, and number of total sessions. Attendance was calculated as the number of participants who completed each session converted into a percentage of the total number of participants. Intervention completion was calculated as the number of sessions completed by an entire team converted into a percentage of the total number of training sessions. These data were used to calculate an overall rate of compliance. Data Synthesis Six of 205 identified studies were included. Incidence rates of ACL injury were lower in studies with high rates of compliance with neuromuscular training than in studies with low compliance rates (incidence rate ratio = 0.27 [95% confidence interval = 0.07, 0.80]). Tertile analysis indicated rates of ACL injury incidence were lower in studies with high compliance rates than in studies with moderate and low compliance rates (incidence rate ratio = 0.18 [95% confidence interval = 0.02, 0.77]). Conclusions A potential inverse dose-response relationship exists between compliance with neuromuscular training and incidence of ACL injury. Attending and completing recommended neuromuscular sessions appears to be an important factor for preventing ACL injuries. PMID:23182020

Parent Experience With False-Positive Newborn Screening Results for Cystic Fibrosis.

PubMed

Hayeems, Robin Z; Miller, Fiona A; Barg, Carolyn J; Bombard, Yvonne; Kerr, Elizabeth; Tam, Karen; Carroll, June C; Potter, Beth K; Chakraborty, Pranesh; Davies, Christine; Milburn, Jennifer; Patton, Sarah; Bytautas, Jessica P; Taylor, Louise; Price, April; Gonska, Tanja; Keenan, Katherine; Ratjen, Felix; Guttmann, Astrid

2016-09-01

The risk of psychosocial harm in families of infants with false-positive (FP) newborn bloodspot screening (NBS) results for cystic fibrosis (CF) is a longstanding concern. Whether well designed retrieval and confirmatory testing systems can mitigate risks remains unknown. Using a mixed-methods cohort design, we obtained prospective self-report data from mothers of infants with FP CF NBS results 2 to 3 months after confirmatory testing at Ontario's largest follow-up center, and from a randomly selected control sample of mothers of screen negative infants from the same region. Mothers completed a questionnaire assessing experience and psychosocial response. A sample of mothers of FP infants completed qualitative interviews. One hundred thirty-four mothers of FP infants (response rate, 55%) and 411 controls (response rate, 47%) completed questionnaires; 54 mothers of FP infants were interviewed. Selected psychosocial response measures did not detect psychosocial distress in newborns or 1 year later (P > .05). Mothers recalled distress during notification of the positive result and in the follow-up testing period related to fear of chronic illness, but valued the screening system of care in mitigating concerns. Although immediate distress was reported among mothers of FP infants, selected psychometric tools did not detect these concerns. The NBS center from which mothers were recruited minimizes delay between notification and confirmatory testing and ensures trained professionals are communicating results and facilitating follow-up. These factors may explain the presence of minimal psychosocial burden. The screening system reflected herein may be a model for NBS programs working to minimize FP-related psychosocial harm. Copyright © 2016 by the American Academy of Pediatrics.

Reirradiation of tumors in cats and dogs.

PubMed

Turrel, J M; Théon, A P

1988-08-15

Fifty-one cats and dogs with tumor recurrence after irradiation were treated with a second course of radiotherapy, using either teletherapy or brachytherapy. Eighty-six percent of the tumors had partial or complete response at 2 months after reirradiation. Tumor response was significantly (P = 0.041) affected when the interval between the 2 courses of irradiation was greater than 5 months. The estimated local tumor control rate was 38% at 1 year after reirradiation. Of all the factors examined, complete response at 2 months, reirradiation field size less than or equal to 10 cm2, and reirradiation dose greater than 40 gray emerged as predictors of local tumor control. The estimated overall survival rate was 47% at 2 years. Tumor location had a significant (P = 0.001) influence on overall survival; animals with cutaneous tumors had the longest survival times, and those with oral tumors had the shortest survival times. The other significant (P = 0.001) factor affecting overall survival time was the field size of the reirradiated site. Estimated survival time after reirradiation was 41% at 1 year. Favorable prognostic indicators were complete response at 2 months and location of tumor; animals with skin tumors had a favorable prognosis. The acute effects of reirradiation on normal tissues were acceptable, but 12% of the animals had severe delayed complications. Significant risk of complications after reirradiation was associated with squamous cell carcinoma (P = 0.015) and reirradiated field size greater than 30 cm2 (P = 0.056). When the interval between irradiations was greater than 5 months, the risk of complications was significantly (P = 0.022) lower.(ABSTRACT TRUNCATED AT 250 WORDS)

Associations of objectively measured physical activity with daily mood ratings and psychophysiological stress responses in women.

PubMed

Poole, Lydia; Steptoe, Andrew; Wawrzyniak, Andrew J; Bostock, Sophie; Mitchell, Ellen S; Hamer, Mark

2011-08-01

The aim of this study was to examine associations of objectively measured physical activity with daily mood ratings and psychophysiological stress responses. We recruited 40 healthy females (aged 28.7 ± 6.1 yrs) who completed a once-a-day mood rating scale for 7 days, along with a 7-day assessment of physical activity using accelerometers and psychophysiological stress testing. The findings suggest that levels of physical activity as measured using an accelerometer are associated with both depressive symptoms over the past 2 weeks (CES-D) (r = - .33, p = .038) and with daily positive emotional style (r = .49, p = .001). The relationship between physical activity and positive emotional style remained after controlling for age, body mass index, and negative emotional style (t = 3.31, p = .002). Physical activity was not related to any psychophysiological stress responses. Copyright © 2011 Society for Psychophysiological Research.

Neoadjuvant conformal chemoradiation with induction chemotherapy for rectal adenocarcinoma. A prospective observational study.

PubMed

Fekete, Zsolt; Muntean, Alina-Simona; Hica, Ştefan; Rancea, Alin; Resiga, Liliana; Csutak, Csaba; Todor, Nicolae; Nagy, Viorica Magdalena

2014-06-01

The purpose of this prospective observational study was to evaluate the rate and the prognostic factors for down-staging and complete response for rectal adenocarcinoma after induction chemotherapy and neoadjuvant chemoradiation followed by surgery, and to analyze the rate of sphincter-saving surgery. We included from March 2011 to October 2013 a number of 88 patients hospitalized with locally advanced rectal adenocarcinoma in the Prof. Dr. Ion Chiricuta Institute of Oncology, Cluj. The treatment schedule included 2-4 cycles of Oxaliplatin plus a fluoropyrimidine followed by concomitant chemoradiation with a dose of 50 Gy in 25 fractions combined with a fluoropyrimidine monotherapy. The rate of T down-staging was 49.4% (40/81 evaluable patients). Independent prognostic factors for T down-staging were: age >57 years (p<0.01), cN0 (p<0.01), distance from anal verge >5 cm (p<0.01), initial CEA <6.2 ng/ml (p<0.01), higher number of chemotherapy cycles with Oxaliplatin (pROC=0.05) and protraction of radiotherapy of >35 days (p<0.01). Nine patients from 81 (11.1%) presented complete response (7 pathological and 2 clinical); the independent prognostic factors were stage cT2 versus cT3-4 (p<0.01), initial tumor size ≤3.5 cm and distance from anal verge >5 cm (p=0.03). Sixty-eight patients (79.1%) underwent radical surgery and among them 35 patients (51.5 %) had a sphincter saving procedure. Induction chemotherapy with neoadjuvant chemoradiation produced important down-staging in rectal adenocarcinoma. Independent prognostic factors for T down-staging were: age, cN0, distance from anal verge, initial CEA, the number of Oxaliplatin cycles and duration of radiotherapy; for complete response: cT2, initial tumor size and distance from the anal verge.

Validation of Patient-Reported Outcomes Measurement Information System Short Forms for Use in Childhood-Onset Systemic Lupus Erythematosus.

PubMed

Jones, Jordan T; Carle, Adam C; Wootton, Janet; Liberio, Brianna; Lee, Jiha; Schanberg, Laura E; Ying, Jun; Morgan DeWitt, Esi; Brunner, Hermine I

2017-01-01

To validate the pediatric Patient-Reported Outcomes Measurement Information System short forms (PROMIS-SFs) in childhood-onset systemic lupus erythematosus (SLE) in a clinical setting. At 3 study visits, childhood-onset SLE patients completed the PROMIS-SFs (anger, anxiety, depressive symptoms, fatigue, physical function-mobility, physical function-upper extremity, pain interference, and peer relationships) using the PROMIS assessment center, and health-related quality of life (HRQoL) legacy measures (Pediatric Quality of Life Inventory, Childhood Health Assessment Questionnaire, Simple Measure of Impact of Lupus Erythematosus in Youngsters [SMILEY], and visual analog scales [VAS] of pain and well-being). Physicians rated childhood-onset SLE activity on a VAS and completed the Systemic Lupus Erythematosus Disease Activity Index 2000. Using a global rating scale of change (GRC) between study visits, physicians rated change of childhood-onset SLE activity (GRC-MD1: better/same/worse) and change of patient overall health (GRC-MD2: better/same/worse). Questionnaire scores were compared in support of validity and responsiveness to change (external standards: GRC-MD1, GRC-MD2). In this population-based cohort (n = 100) with a mean age of 15.8 years (range 10-20 years), the PROMIS-SFs were completed in less than 5 minutes in a clinical setting. The PROMIS-SF scores correlated at least moderately (Pearson's r ≥ 0.5) with those of legacy HRQoL measures, except for the SMILEY. Measures of childhood-onset SLE activity did not correlate with the PROMIS-SFs. Responsiveness to change of the PROMIS-SFs was supported by path, mixed-model, and correlation analyses. To assess HRQoL in childhood-onset SLE, the PROMIS-SFs demonstrated feasibility, internal consistency, construct validity, and responsiveness to change in a clinical setting. © 2016, American College of Rheumatology.

National survey of physicians to determine the effect of unconditional incentives on response rates of physician postal surveys.

PubMed

Abdulaziz, Kasim; Brehaut, Jamie; Taljaard, Monica; Émond, Marcel; Sirois, Marie-Josée; Lee, Jacques S; Wilding, Laura; Perry, Jeffrey J

2015-02-18

Physicians are a commonly targeted group in health research surveys, but their response rates are often relatively low. The goal of this paper was to evaluate the effect of unconditional incentives in the form of a coffee card on physician postal survey response rates. Following 13 key informant interviews and eight cognitive interviews a survey questionnaire was developed. A random sample of 534 physicians, stratified by physician group (geriatricians, family physicians, emergency physicians) was selected from a national medical directory. Using computer generated random numbers; half of the physicians in each stratum were allocated to receive a coffee card to a popular national coffee chain together with the first survey mailout. The intervention was a $10 Tim Hortons gift card given to half of the physicians who were randomly allocated to receive the incentive. 265 (57.0%) physicians completed the survey. The response rate was significantly higher in the group allocated to receive the incentive (62.7% vs 51.3% in the control group; p=0.01). Our results indicate that an unconditional incentive in the form of a coffee gift card can substantially improve physician response rates. Future research can look at the effect of varying amounts of cash on the gift cards on response rates. 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.

The Evoked Potential. An Experimental Method for Biomechanical Analysis of Brain and Spinal Injury

DTIC Science & Technology

1980-01-01

Newtons produced marked changes in blood pressure, heart rate and distraction of the cervical spinal column with minimal ligamentous disruption...pathologic distraction and pathologic flexion of the thoracic ver- tebral column (8). Cerebral responses were lost within two minutes aftex complete...However, the immediate flexion and distraction responses were not altered. These findings suggest that mechanical trauma alters the spinal cord evoked

Heart Rate Response in Spectators of the Montreal Canadiens Hockey Team.

PubMed

Khairy, Leia T; Barin, Roxana; Demonière, Fabrice; Villemaire, Christine; Billo, Marie-Josée; Tardif, Jean-Claude; Macle, Laurent; Khairy, Paul

2017-12-01

To our knowledge, heart rate responses have not previously been assessed in hockey fans. We quantified heart rate increases in spectators of the Montreal Canadiens, compared televised with live games, explored features associated with peak heart rates, and assessed whether increases correlate with a fan passion score. Healthy adults were enrolled, with half attending live games and half viewing televised games. All subjects completed questionnaires and had continuous Holter monitoring. Intensity of the physical stress response was defined according to previously published heart rate index thresholds as mild (< 1.33), moderate (1.33-1.83), or vigorous (> 1.83). In 20 participants, 35% women, age 46 ± 10 years, the heart rate increased by a median of 92% during the hockey game, from 60 (interquartile range, 54-65) beats per minute at rest to 114 (interquartile range, 103-129) beats per minute (P < 0.001). The heart rate increased by 110% vs 75% during live vs televised games (P < 0.001). Heart rate index (2.16 ± 0.27 vs 1.73 ± 0.15; P < 0.001) and percent maximum predicted heart rate attained (75% ± 8% vs 58% ± 7%; P < 0.001) were significantly higher during live vs televised games. Number of premature beats was nonsignificantly higher during live games (5 vs 1; P = 0.181). The fan passion score was not predictive of the heart rate response (P = 0.753). Peak heart rates most commonly occurred during overtime (40%) and scoring opportunities for (25%) and against (15%). It is exciting to watch the Montreal Canadiens! Viewing a live hockey game is associated with a heart rate response equivalent to vigorous physical stress and a televised game to moderate physical stress. Copyright © 2017 Canadian Cardiovascular Society. Published by Elsevier Inc. All rights reserved.

Italian real life experience with ibrutinib: results of a large observational study on 77 relapsed/refractory mantle cell lymphoma.

PubMed

Broccoli, Alessandro; Casadei, Beatrice; Morigi, Alice; Sottotetti, Federico; Gotti, Manuel; Spina, Michele; Volpetti, Stefano; Ferrero, Simone; Spina, Francesco; Pisani, Francesco; Merli, Michele; Visco, Carlo; Paolini, Rossella; Zilioli, Vittorio Ruggero; Baldini, Luca; Di Renzo, Nicola; Tosi, Patrizia; Cascavilla, Nicola; Molica, Stefano; Ilariucci, Fiorella; Rigolin, Gian Matteo; D'Alò, Francesco; Vanazzi, Anna; Santambrogio, Elisa; Marasca, Roberto; Mastrullo, Lucia; Castellino, Claudia; Desabbata, Giovanni; Scortechini, Ilaria; Trentin, Livio; Morello, Lucia; Argnani, Lisa; Zinzani, Pier Luigi

2018-05-04

Although sometimes presenting as an indolent lymphoma, mantle cell lymphoma (MCL) is an aggressive disease, hardly curable with standard chemo-immunotherapy. Current approaches have greatly improved patients' outcomes, nevertheless the disease is still characterized by high relapse rates. Before approval by EMA, Italian patients with relapsed/refractory MCL were granted ibrutinib early access through a Named Patient Program (NPP). An observational, retrospective, multicenter study was conducted. Seventy-seven heavily pretreated patients were enrolled. At the end of therapy there were 14 complete responses and 14 partial responses, leading to an overall response rate of 36.4%. At 40 months overall survival was 37.8% and progression free survival was 30%; disease free survival was 78.6% at 4 years: 11/14 patients are in continuous complete response with a median of 36 months of follow up. Hematological toxicities were manageable, and main extra-hematological toxicities were diarrhea (9.4%) and lung infections (9.0%). Overall, 4 (5.2%) atrial fibrillations and 3 (3.9%) hemorrhagic syndromes occurred. In conclusions, thrombocytopenia, diarrhea and lung infections are the relevant adverse events to be clinically focused on; regarding effectiveness, ibrutinib is confirmed to be a valid option for refractory/relapsed MCL also in a clinical setting mimicking the real world.

High Proliferation Predicts Pathological Complete Response to Neoadjuvant Chemotherapy in Early Breast Cancer

PubMed Central

Lluch, Ana; Ribelles, Nuria; Anton-Torres, Antonio; Sanchez-Rovira, Pedro; Albanell, Joan; Calvo, Lourdes; García-Asenjo, Jose Antonio Lopez; Palacios, Jose; Chacon, Jose Ignacio; Ruiz, Amparo; De la Haba-Rodriguez, Juan; Segui-Palmer, Miguel A.; Cirauqui, Beatriz; Margeli, Mireia; Plazaola, Arrate; Barnadas, Agusti; Casas, Maribel; Caballero, Rosalia; Carrasco, Eva; Rojo, Federico

2016-01-01

Background. In the neoadjuvant setting, changes in the proliferation marker Ki67 are associated with primary endocrine treatment efficacy, but its value as a predictor of response to chemotherapy is still controversial. Patients and Methods. We analyzed 262 patients with centralized basal Ki67 immunohistochemical evaluation derived from 4 GEICAM (Spanish Breast Cancer Group) clinical trials of neoadjuvant chemotherapy for breast cancer. The objective was to identify the optimal threshold for Ki67 using the receiver-operating characteristic curve method to maximize its predictive value for chemotherapy benefit. We also evaluated the predictive role of the defined Ki67 cutoffs for molecular subtypes defined by estrogen receptor (ER) and human epidermal growth factor receptor 2 (HER2). Results. A basal Ki67 cutpoint of 50% predicted pathological complete response (pCR). Patients with Ki67 >50% achieved a pCR rate of 40% (36 of 91) versus a pCR rate of 19% in patients with Ki67 ≤50% (33 of 171) (p = .0004). Ki67 predictive value was especially relevant in ER-HER2− and ER-HER2+ patients (pCR rates of 42% and 64%, respectively, in patients with Ki67 >50% versus 15% and 45%, respectively, in patients with Ki67 ≤50%; p = .0337 and .3238, respectively). Both multivariate analyses confirmed the independent predictive value of the Ki67 cutpoint of 50%. Conclusion. Basal Ki67 proliferation index >50% should be considered an independent predictive factor for pCR reached after neoadjuvant chemotherapy, suggesting that cell proliferation is a phenomenon closely related to chemosensitivity. These findings could help to identify a group of patients with a potentially favorable long-term prognosis. Implications for Practice: The use of basal Ki67 status as a predictive factor of chemotherapy benefit could facilitate the identification of a patient subpopulation with high probability of achieving pathological complete response when treated with primary chemotherapy, and thus with a potentially favorable long-term prognosis. PMID:26786263

System analysis of the dynamic response of the coronary circulation to a sudden change in heart rate.

PubMed

Dankelman, J; Stassen, H G; Spaan, J A

1990-03-01

In this study the response of driving pressure/flow ration on an abrupt change in heart rate was analysed. The difference between the response obtained with constant pressure and constant flow perfusion was also studied. The responses show a fast initial reversed phase followed by a slow phase caused by regulation. To test whether the initial phase could be the result of mechanical changes in the coronary circulation, a model for regulation was extended by the addition of four different mechanical models originating from the literature. These extended models were able to explain the fast initial phase. However, the mechanical model consisting of an intramyocardial compliance (C = 0.08 ml mm Hg-1 100 g-1) with a variable venous resistance, and the model consisting of a waterfall and a small compliance (C = 0.007 ml mm Hg-1 100g-1) both explained these responses best. The analysis showed that there is no direct relationship between rate of change of vascular tone and rate of change of pressure/flow ratio. However, on the basis of the two extended models, it can be predicted that the half-time for the response of regulation to be complete is about 9s with constant pressure perfusion and 15 s with constant flow perfusion.

A randomised controlled trial to determine the effect on response of including a lottery incentive in health surveys [ISRCTN32203485

PubMed Central

Roberts, LM; Wilson, S; Roalfe, A; Bridge, P

2004-01-01

Background Postal questionnaires are an economical and simple method of data collection for research purposes but are subject to non-response bias. Several studies have explored the effect of monetary and non-monetary incentives on response. Recent meta-analyses conclude that financial incentives are an effective way of increasing response rates. However, large surveys rarely have the resources to reward individual participants. Three previous papers report on the effectiveness of lottery incentives with contradictory results. This study aimed to determine the effect of including a lottery-style incentive on response rates to a postal health survey. Methods Randomised controlled trial. Setting: North and West Birmingham. 8,645 patients aged 18 or over randomly selected from registers of eight general practices (family physician practices). Intervention: Inclusion of a flyer and letter with a health questionnaire informing patients that returned questionnaires would be entered into a lottery-style draw for £100 of gift vouchers. Control: Health questionnaire accompanied only by standard letter of explanation. Main outcome measures: Response rate and completion rate to questionnaire. Results 5,209 individuals responded with identical rates in both groups (62.1%). Practice, patient age, sex and Townsend score (a postcode based deprivation measure) were identified as predictive of response, with higher response related to older age, being female and living in an area with a lower Townsend score (less deprived). Conclusion This RCT, using a large community based sample, found that the offer of entry into a lottery style draw for £100 of High Street vouchers has no effect on response rates to a postal health questionnaire. PMID:15533256

Lottery ticket was more effective than a prize draw in increasing questionnaire response among cancer survivors.

PubMed

Drummond, Frances J; O'Leary, Eamonn; Sharp, Linda

2015-07-01

Compare the effect of financial incentives on response to a cancer survivors' postal questionnaire. Prostate cancer survivors in Ireland, 1.5-18 years after diagnosis, were randomized to the (1) "lottery" arm [a € 1 lottery scratch card sent with the questionnaire (n = 2,413)] or (2) "prize" arm [entry into a draw on return of a completed questionnaire (n = 2,407)]. Impact of interventions on response overall and by survival period ("short term": < 5 years after diagnosis; "long term": ≥ 5 years after diagnosis) was compared as was cost-effectiveness. Adjusted response rate was 54.4%. Response was higher among younger men (P < 0.001) and those with earlier stage disease (P = 0.002). A modest 2.6% higher response rate was observed in the lottery compared with the prize arm [multivariate relative risk (RR) = 1.06; 95% confidence interval (CI): 1.00, 1.11]. When stratified by survival period, higher response in the lottery arm was only observed among long-term survivors (multivariate RR = 1.10; 95% CI: 1.02, 1.19; short-term survivors: RR = 1.01; 95% CI: 0.94, 1.09). Costs per completed questionnaire were € 4.54 and € 3.57 for the lottery and prize arms, respectively. Compared with the prize arm, cost per additional questionnaire returned in the lottery arm was € 25.65. Although more expensive, to optimize response to postal questionnaires among cancer survivors, researchers might consider inclusion of a lottery scratch card. Copyright © 2015 Elsevier Inc. All rights reserved.

Stereotactic body radiotherapy for de novo spinal metastases: systematic review.

PubMed

Husain, Zain A; Sahgal, Arjun; De Salles, Antonio; Funaro, Melissa; Glover, Janis; Hayashi, Motohiro; Hiraoka, Masahiro; Levivier, Marc; Ma, Lijun; Martínez-Alvarez, Roberto; Paddick, J Ian; Régis, Jean; Slotman, Ben J; Ryu, Samuel

2017-09-01

OBJECTIVE The aim of this systematic review was to provide an objective summary of the published literature pertaining to the use of stereotactic body radiation therapy (SBRT) specific to previously untreated spinal metastases. METHODS The authors performed a systematic review, using Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines, of the literature found in a search of Medline, PubMed, Embase, and the Cochrane Library up to March 2015. The search strategy was limited to publications in the English language. RESULTS A total of 14 full-text articles were included in the analysis. All studies were retrospective except for 2 studies, which were prospective. A total of 1024 treated spinal lesions were analyzed. The median follow-up time ranged from 9 to 49 months. A range of dose-fractionation schemes was used, the most common of which were 16-24 Gy/1 fraction (fx), 24 Gy/2 fx, 24-27 Gy/3 fx, and 30-35 Gy/5 fx. In studies that reported crude results regarding in-field local tumor control, 346 (85%) of 407 lesions remained controlled. For studies that reported actuarial values, the weighted average revealed a 90% 1-year local control rate. Only 3 studies reported data on complete pain response, and the weighted average of these results yielded a complete pain response rate of 54%. The most common toxicity was new or progressing vertebral compression fracture, which was observed in 9.4% of cases; 2 cases (0.2%) of neurologic injury were reported. CONCLUSION There is a paucity of prospective data specific to SBRT in patients with spinal metastases not otherwise irradiated. This systematic review found that SBRT is associated with favorable rates of local control (approximately 90% at 1 year) and complete pain response (approximately 50%), and low rates of serious adverse events were found. Practice guidelines are summarized based on these data and International Stereotactic Radiosurgery Society consensus.

Micromechanical modeling of damage growth in titanium based metal-matrix composites

NASA Technical Reports Server (NTRS)

Sherwood, James A.; Quimby, Howard M.

1994-01-01

The thermomechanical behavior of continuous-fiber reinforced titanium based metal-matrix composites (MMC) is studied using the finite element method. A thermoviscoplastic unified state variable constitutive theory is employed to capture inelastic and strain-rate sensitive behavior in the Timetal-21s matrix. The SCS-6 fibers are modeled as thermoplastic. The effects of residual stresses generated during the consolidation process on the tensile response of the composites are investigated. Unidirectional and cross-ply geometries are considered. Differences between the tensile responses in composites with perfectly bonded and completely debonded fiber/matrix interfaces are discussed. Model simulations for the completely debonded-interface condition are shown to correlate well with experimental results.

Clinical outcome and prognosis of carbon ion radiotherapy on thoracic malignant tumors

NASA Astrophysics Data System (ADS)

Li, Sha

Objective To evaluate the therapeutic efficacy and side-response of high-LET carbon ion radiotherapy on thoracic malignant tumors. Methods Ten patients with pathological confirmed thoracic malignant tumors received treatment using heavy ion accelerator, which included 6 cases with non-small lung cancer, one case with small lung cancer, 2 cases with metastatic sarcomas and one case with invasive thymoma. The applied regimen included fractioned dose (5.5-6.8GyE/Fraction), one faction/day, and 7 fractions/week. The total dose ranged from 55 to 70 GyE. Results The short-term results showed that the response rate (the complete response (CR) rate +the partial response (PR) rate) was 10% at the first month, 40% at the third month and 90% at the sixth month. The overall response rate was 90% and the rate of stable disease was 10%. There was no relation between the response rate and tumor pathology (P>0.05) while significance between the response rate and the tumor volume.At median follow-up of 27 months (range, 6 to 36 months), the local control rate and free-disease rate were respectively 100% an 90% at the first year, 90% and 80% at the secondary year, 80% and 70% at the third year. The death rate due to disease progression was 20% and the non-specific death rate was 10%. Side and toxicity effects: Grade I skin effect occurred in three cases and Grade I lung effect occurred in two cases. The blood counts didn’t reach significance among pre-radiation course, peri-radiation course and post-radiation course (P>0.05). The subgoups of T cells detected in humoral immunity and cytoimmunity didn’t change between pre-radiation and post radiation(P>0.05). Conclusions Carbon ion radiotherapy is effective and safe in the management of patients with thoracic malignant tumors. There were no obvious side effects. The long term of clinical outcome and the late effect need to be further observed.

A double-blind placebo-controlled study into the efficacy of a homeopathic remedy for fear of firework noises in the dog (Canis familiaris).

PubMed

Cracknell, Nina R; Mills, Daniel S

2008-07-01

Seventy-five dogs that showed a fear response to fireworks participated in a double-blinded, placebo-controlled clinical trial to assess the efficacy of a homeopathic remedy for the alleviation of their behavioural signs. Dogs were randomly assigned to one of two treatments; the homeopathic treatment or the placebo treatment. At the baseline assessments the owners identified the behavioural signs of fear that their dogs normally displayed in response to fireworks, rated their frequency and intensity, and assessed the global severity of their dog's responses. These measures were repeated at the final assessment and owners also completed weekly diaries for the length of the trial. There were significant improvements in the owners' rating of 14/15 behavioural signs of fear in the placebo treatment group and all 15 behavioural signs in the homeopathic treatment group. Both treatment groups also showed significant improvement in the owners' rating of the global severity of their dog's responses. However, there was no significant difference in the response seen between the two treatment groups.

Low Estrogen Receptor (ER)-Positive Breast Cancer and Neoadjuvant Systemic Chemotherapy: Is Response Similar to Typical ER-Positive or ER-Negative Disease?

PubMed

Landmann, Alessandra; Farrugia, Daniel J; Zhu, Li; Diego, Emilia J; Johnson, Ronald R; Soran, Atilla; Dabbs, David J; Clark, Beth Z; Puhalla, Shannon L; Jankowitz, Rachel C; Brufsky, Adam M; Ahrendt, Gretchen M; McAuliffe, Priscilla F; Bhargava, Rohit

2018-05-08

Pathologic complete response (pCR) rate after neoadjuvant chemotherapy was compared between 141 estrogen receptor (ER)-negative (43%), 41 low ER+ (13%), 47 moderate ER+ (14%), and 98 high ER+ (30%) tumors. Human epidermal growth factor receptor 2-positive cases, cases without semiquantitative ER score, and patients treated with neoadjuvant endocrine therapy alone were excluded. The pCR rate of low ER+ tumors was similar to the pCR rate of ER- tumors (37% and 26% for low ER and ER- respectively, P = .1722) but significantly different from the pCR rate of moderately ER+ (11%, P = .0049) and high ER+ tumors (4%, P < .0001). Patients with pCR had an excellent prognosis regardless of the ER status. In patients with residual disease (no pCR), the recurrence and death rate were higher in ER- and low ER+ cases compared with moderate and high ER+ cases. Low ER+ breast cancers are biologically similar to ER- tumors. Semiquantitative ER H-score is an important determinant of response to neoadjuvant chemotherapy.

Barriers towards the publication of academic drug trials. Follow-up of trials approved by the Danish Medicines Agency.

PubMed

Berendt, Louise; Petersen, Lene Grejs; Bach, Karin Friis; Poulsen, Henrik Enghusen; Dalhoff, Kim

2017-01-01

To characterize and quantify barriers towards the publication of academic drug trials. We identified academic drug trials approved during a 3-year period (2004-2007) by the Danish Medicines Agency. We conducted a survey among the trial sponsors to describe the rates of initiation, completion, and publication, and the reasons for the failure to reach each of these milestones. Information on size and methodological characteristics of the trials was extracted from the EudraCT database, a prospective register of all approved clinical drug trials submitted to European medicines agencies since 2004. A total of 181 academic drug trials were eligible for inclusion, 139 of which participated in our survey (response rate: 77%). Follow-up time ranged from 5.1 to 7.9 years. Most trials were randomized controlled trials (73%, 95% CI 65-81%). Initiation and completion rates were 92% (95% CI: 88-97%) and 93% (95% CI: 89-97%) respectively. The publication rate of completed trials was 73% (95% CI: 62-79%). RCTs were published faster than non-RCTs (quartile time to publication 2.9 vs. 3.1 years, p = 0.0412). Many academic drug trials are left unpublished. Main barriers towards publication were related to the process from completion to publication. Hence, there is much to gain by facilitating the process from analysis to publication. Research institutions and funders should actively influence this process, e.g. by requiring the publication of trial results within a given time after completion.

77 FR 16870 - Proposed Collection; Comment Request

Federal Register 2010, 2011, 2012, 2013, 2014

2012-03-22

... take into account the frequency, volume, and duration of the employees' unemployment and sickness benefits. Each employer's contribution rate includes a component for administrative expenses as well as a... response is requested quarterly of each respondent and completion is mandatory. The RRB proposes no changes...

A randomized trial of the impact of survey design characteristics on response rates among nursing home providers.

PubMed

Clark, Melissa; Rogers, Michelle; Foster, Andrew; Dvorchak, Faye; Saadeh, Frances; Weaver, Jessica; Mor, Vincent

2011-12-01

An experiment was conducted to maximize participation of both the Director of Nursing (DoN) and the Administrator (ADMIN) in long-term care facilities. Providers in each of the 224 randomly selected facilities were randomly assigned to 1 of 16 conditions based on the combination of data collection mode (web vs. mail), questionnaire length (short vs. long), and incentive structure. Incentive structures were determined by amount compensated if the individual completed and an additional amount per individual if the pair completed (a) $30 individual/$5 pair/$35 total; (b) $10 individual/$25 pair/$35 total; (c) $30 individual/$20 pair/$50 total; and (d) $10 individual/$40 pair/$50 total. Overall, 47.4% of eligible respondents participated; both respondents participated in 29.3% of facilities. In multivariable analyses, there were no differences in the likelihood of both respondents participating by mode, questionnaire length, or incentive structure. Providing incentives contingent on participation by both providers of a facility was an ineffective strategy for significantly increasing response rates.

Feasibility of collecting 24-h urine to monitor sodium intake in the National Health and Nutrition Examination Survey123

PubMed Central

Terry, Ana L; Cogswell, Mary E; Wang, Chia-Yih; Chen, Te-Ching; Loria, Catherine M; Wright, Jacqueline D; Zhang, Xinli; Lacher, David A; Merritt, Robert K; Bowman, Barbara A

2016-01-01

Background: Twenty-four–hour urine sodium excretion is recommended for monitoring population sodium intake. Because of concerns about participation and completion, sodium excretion has not been collected previously in US nationally representative surveys. Objective: We assessed the feasibility of implementing 24-h urine collections as part of a nationally representative survey. Design: We selected a random half sample of nonpregnant US adults aged 20–69 y in 3 geographic locations of the 2013 NHANES. Participants received explicit instructions, started and ended the urine collection in a urine study mobile examination center, and answered questions about their collection. Among those with a complete 24-h urine collection, a random one-half were asked to collect a second 24-h urine sample. Sodium, potassium, chloride, and creatinine excretion were analyzed. Results: The final NHANES examination response rate for adults aged 20–69 y in these 3 study locations was 71%. Of those examined (n = 476), 282 (59%) were randomly selected to participate in the 24-h urine collection. Of these, 212 persons [75% of those selected for 24-h urine collection; 53% (equal to 71% × 75% of those selected for the NHANES)] collected a complete initial 24-h specimen and 92 persons (85% of 108 selected) collected a second complete 24-h urine sample. More men than women completed an initial collection (P = 0.04); otherwise, completion did not vary by sociodemographic characteristics, body mass index, education, or employment status for either collection. Mean 24-h urine volume and sodium excretion were 1964 ± 1228 mL and 3657 ± 2003 mg, respectively, for the first 24-h urine sample, and 2048 ± 1288 mL and 3773 ± 1891 mg, respectively, for the second collection. Conclusion: Given the 53% final component response rate and 75% completion rate, 24-h urine collections were deemed feasible and implemented in the NHANES 2014 on a subsample of adults aged 20–69 y to assess population sodium intake. This study was registered at clinicaltrials.gov as NCT02723682. PMID:27413136

Advantages and limitations of web-based surveys: evidence from a child mental health survey.

PubMed

Heiervang, Einar; Goodman, Robert

2011-01-01

Web-based surveys may have advantages related to the speed and cost of data collection as well as data quality. However, they may be biased by low and selective participation. We predicted that such biases would distort point-estimates such as average symptom level or prevalence but not patterns of associations with putative risk-factors. A structured psychiatric interview was administered to parents in two successive surveys of child mental health. In 2003, parents were interviewed face-to-face, whereas in 2006 they completed the interview online. In both surveys, interviews were preceded by paper questionnaires covering child and family characteristics. The rate of parents logging onto the web site was comparable to the response rate for face-to-face interviews, but the rate of full response (completing all sections of the interview) was much lower for web-based interviews. Full response was less frequent for non-traditional families, immigrant parents, and less educated parents. Participation bias affected point estimates of psychopathology but had little effect on associations with putative risk factors. The time and cost of full web-based interviews was only a quarter of that for face-to-face interviews. Web-based surveys may be performed faster and at lower cost than more traditional approaches with personal interviews. Selective participation seems a particular threat to point estimates of psychopathology, while patterns of associations are more robust.

Chemotherapy for neuroendocrine tumors: the Beatson Oncology Centre experience.

PubMed

Hatton, M Q; Reed, N S

1997-01-01

The role of chemotherapy in malignant neuroendocrine tumours is difficult to assess because of their rarity and variation in biological behaviour. We present a retrospective review of chemotherapy given to 18 patients with metastatic and one with locally advanced neuroendocrine tumours. There were eight poorly differentiated neuroendocrine tumours, six thyroid medullary carcinomas, two phaeochromocytomas, two pancreatic islet cell tumours and one undifferentiated neuroblastoma. Four patients were given 3-weekly dacarbazine, vincristine and cyclophosphamide (DOC) chemotherapy. In eight patients, this regimen was modified by substituting the dacarbazine and cisplatin and etoposide (OPEC). A further six patients were treated with dacarbazine reintroduced into the 3-weekly regimen (DOPEC). The remaining patient received cisplatin and etoposide. There were two complete responses (both with OPEC) and eight partial responses (two with DOC, three with OPEC and three with DOPEC). Five patients had stable disease and four progressed. Four received further chemotherapy on relapse, producing one complete and one partial response. The median response duration to initial chemotherapy was 10 months (range 3-34). The median survival was 12 months (range 1-42). The main toxicity was haematological, with grade 3-4 neutropenia in 12 patients; eight suffered episodes of sepsis. One death was treatment related. Other toxicity was mild although three patients discontinued vincristine with grade 2 neurotoxicity. The response rate and side effects of these three regimens appear comparable. We conclude that, although these patient numbers are small, combination chemotherapy produces an encouraging response rate (53%; 95% CI 30-75) in malignant neuroendocrine tumours, with acceptable toxicity.

Operational fitness of box truss antennas in response to dynamic slewing

NASA Technical Reports Server (NTRS)

Bachtell, E. E.; Bettadapur, S. S.; Schartel, W. A.; Karanian, L. A.

1985-01-01

A parametric study was performed to define slewing capability of large satellites along with associated system changes or subsystem weight and complexity impacts. The satellite configuration and structural arrangement from the Earth Observation Spacecraft (EOS) study was used as the baseline spacecraft. Varying slew rates, settling times, damping, maneuver frequencies, and attitude hold times provided the data required to establish applicability to a wide range of potential missions. The key elements of the study are: (1) determine the dynamic transient response of the antenna system; (2) calculate the system errors produced by the dynamic response; (3) determine if the antenna has exceeded operational requirements at completion of the slew, and if so; (4) determine when the antenna has settled to the operational requirements. The slew event is not considered complete until the antenna is within operational limits.

The Success Rate of Neurology Residents in EEG Interpretation After Formal Training.

PubMed

Dericioglu, Nese; Ozdemir, Pınar

2018-03-01

EEG is an important tool for neurologists in both diagnosis and classification of seizures. It is not uncommon in clinical practice to see patients who were erroneously diagnosed as epileptic. Most of the time incorrect interpretation of EEG contributes significantly to this problem. In this study, we aimed to investigate the success rate of neurology residents in EEG interpretation after formal training. Eleven neurology residents were included in the study. Duration of EEG training (3 vs 4 months) and time since completion of EEG education were determined. Residents were randomly presented 30 different slides of representative EEG screenshots. They received 1 point for each correct response. The effect of training duration and time since training were investigated statistically. Besides, we looked at the success rate of each question to see whether certain patterns were more readily recognized than others. EEG training duration ( P = .93) and time since completion of training ( P = .16) did not influence the results. The success rate of residents for correct responses was between 17% and 50%. On the other hand, the success rate for each question varied between 0% and 91%. Overall, benign variants and focal ictal onset patterns were the most difficult to recognize. On 13 occasions (6.5%) nonepileptiform patterns were thought to represent epileptiform abnormalities. After formal training, neurology residents could identify ≤50% of the EEG patterns correctly. The wide variation in success rate among residents and also between questions implies that both personal characteristics and inherent EEG features influence successful EEG interpretation.

Higher Dose Imatinib for Children With De Novo Chronic Phase Chronic Myelogenous Leukemia: A Report From the Children’s Oncology Group

PubMed Central

Champagne, Martin A.; Fu, Cecilia H.; Chang, Myron; Chen, Helen; Gerbing, Robert B.; Alonzo, Todd A.; Cooley, Linda D.; Heerema, Nyla A.; Oehler, Vivian; Wood, Charlotte; French, Mary Ellen; Arceci, Robert J.; Smith, Franklin O.; Bernstein, Mark L.

2016-01-01

Purpose To determine the efficacy of imatinib in children with newly diagnosed chronic phase (CP) chronic myelogenous leukemia (CML). Methods This was an open label, multi-center phase II clinical trial. Courses were defined as consecutive 28-day intervals. Oral imatinib was administered daily at 340 mg/m2 without interruption in the absence of toxicity. Results Fifty-one children received 978 28-day courses of imatinib. The most common toxicities encountered were hematologic. Forty-one patients (80%) achieved a complete hematologic response by the end of course 2. Nineteen children (38%) obtained a complete cytogenetic response (CCyR) at the end of course 3. Overall, 72% achieved CCyR at a median time of 5.6 months. The rate of complete molecular response (>3 log reduction) was 27%. Progression-free and overall survival at 3 years were 72% ± 6.4% and 92% ± 3.9%, respectively. Conclusions Daily oral imatinib at a dose of 340 mg/m2 is well tolerated in children. In addition, imatinib therapy is effective in inducing a high percent of hematologic, cytogenetic and molecular responses, comparable to adults with CML. PMID:21465636

A comparison of placebo response with major depressive disorder in patients recruited through newspaper advertising versus consultation referrals.

PubMed

Miller, C A; Hooper, C L; Bakish, D

1997-01-01

Recent evidence indicates few differences between patients recruited through advertising and by consultation referral, and there is some suggestion that those recruited through advertising are more representative of the target community population. However little has been reported on differences in placebo response and compliance in these two patient groups. We conducted a retrospective chart review of 49 patients with major depressive disorder (MDD), recruited through advertising or consultation, randomized to placebo in five clinical trials. Variables included demographics, clinical history, efficacy, compliance, and completion data. Homogeneity was demonstrated for most variables. Differences in placebo groups included significantly lower Hamilton Rating Scale for Depression (HAM-D) scores for the advertisement group throughout the trials. Advertisement patients were also more likely to be early placebo responders and in remission at Days 14 and 28. No differences were found in completion rates or reasons for early termination. Compliance was excellent for both groups. Early placebo response of the advertisement group reinforces the need for trials of at least 8 weeks. In addition, consultation patients may have a more severe illness and be treatment resistant, suggesting they are less generalizable to community practice populations.

The use of vignettes to empower effective responses to attempted sexual assault.

PubMed

Allen, Kaylie T; Meadows, Elizabeth A

2017-01-01

Women assertively resisting sexual aggression have the best chances of avoiding completed rape. Especially with acquaintances, there are significant social and psychological barriers to resistance. Novel vignettes depicting acquaintance rape were designed to enhance self-efficacy, reduce unrealistic optimism, and empower assertive resistance. The data were collected using a Web-based survey of 449 female college students from multiple universities in August-October 2014. Between-subjects mixed-methods design. Participants were randomly assigned to read one of four vignettes and complete self-report measures of personal vulnerability, self-efficacy, and beliefs and intention about resistance. Although vignettes did not impact self-efficacy, one vignette enhanced perceived controllability and decreased unrealistic optimism. Women who read about completed acquaintance rape described intention to use physically assertive responses at double the rate of women reading about successful resistance. As low-cost, easily disseminated materials, vignettes about sexual assault may enhance campus prevention efforts.

Professional Stereotypes of Interprofessional Education Naive Pharmacy and Nursing Students.

PubMed

Thurston, Maria Miller; Chesson, Melissa M; Harris, Elaine C; Ryan, Gina J

2017-06-01

Objective. To assess and compare interprofessional education (IPE) naive pharmacy and nursing student stereotypes prior to completion of an IPE activity. Methods. Three hundred and twenty-three pharmacy students and 275 nursing students at Mercer University completed the Student Stereotypes Rating Questionnaire. Responses from pharmacy and nursing students were compared, and responses from different level learners within the same profession also were compared. Results. Three hundred and fifty-six (59.5%) students completed the survey. Pharmacy students viewed pharmacists more favorably than nursing students viewed pharmacists for all attributes except the ability to work independently. Additionally, nursing students viewed nurses less favorably than pharmacy students viewed nurses for academic ability and practical skills. There was some variability in stereotypes between professional years. Conclusion. This study confirms the existence of professional stereotypes, although overall student perceptions of their own profession and the other were generally positive.

Professional Stereotypes of Interprofessional Education Naive Pharmacy and Nursing Students

PubMed Central

Thurston, Maria Miller; Harris, Elaine C.; Ryan, Gina J.

2017-01-01

Objective. To assess and compare interprofessional education (IPE) naive pharmacy and nursing student stereotypes prior to completion of an IPE activity. Methods. Three hundred and twenty-three pharmacy students and 275 nursing students at Mercer University completed the Student Stereotypes Rating Questionnaire. Responses from pharmacy and nursing students were compared, and responses from different level learners within the same profession also were compared. Results. Three hundred and fifty-six (59.5%) students completed the survey. Pharmacy students viewed pharmacists more favorably than nursing students viewed pharmacists for all attributes except the ability to work independently. Additionally, nursing students viewed nurses less favorably than pharmacy students viewed nurses for academic ability and practical skills. There was some variability in stereotypes between professional years. Conclusion. This study confirms the existence of professional stereotypes, although overall student perceptions of their own profession and the other were generally positive. PMID:28720912

Cyclophosphamide, bortezomib and dexamethasone (CyBorD) induction for newly diagnosed multiple myeloma: High response rates in a phase II clinical trial

PubMed Central

Reeder, Craig B.; Reece, Donna E.; Kukreti, Vishal; Chen, Christine; Trudel, Suzanne; Hentz, Joseph; Noble, Brie; Pirooz, Nicholas A.; Spong, Jacy E.; Piza, Jesus G.; Zepeda, Victor H. Jimenez; Mikhael, Joseph R.; Leis, Jose F.; Bergsagel, P. Leif; Fonseca, Rafael; Stewart, A. Keith

2009-01-01

We have studied a three drug combination with bortezomib, cyclophosphamide and dexamethasone (CyBorD) on a 28 day cycle in the treatment of newly diagnosed multiple myeloma patients to assess response and toxicity. The primary endpoint of response was evaluated after four cycles. Thirty-three newly diagnosed, symptomatic patients with multiple myeloma received bortezomib 1.3 mg/m2 intravenously on days 1, 4, 8, 11, cyclophosphamide 300 mg/m2 orally days 1, 8, 15, 22 and dexamethasone 40 mg orally days 1-4, 9-12, 17-20 on a 28 day cycle for four cycles. Responses were rapid with a mean 80% decline in the sentinel monoclonal protein at the end of two cycles. The overall intent to treat response rate (≥ partial response) was 88% with 61% ≥VGPR and 39% CR/nCR. For the 28 patients that completed all 4 cycles of therapy the CR/nCR rate was 46% and ≥VGPR rate 71%. All patients undergoing stem cell harvest had a successful collection. Twenty three patients underwent SCT and are evaluable through day 100 with CR/nCR documented in 70% and ≥VGPR in 74%. In conclusion, CyBorD produces a rapid and profound response in patients with newly diagnosed multiple myeloma with manageable toxicity. PMID:19225538

Peginterferon alfa-2a and ribavirin for 24 weeks in hepatitis C type 1 and 4 patients with rapid virological response.

PubMed

Ferenci, Peter; Laferl, Hermann; Scherzer, Thomas-Matthias; Gschwantler, Michael; Maieron, Andreas; Brunner, Harald; Stauber, Rudolf; Bischof, Martin; Bauer, Bernhard; Datz, Christian; Löschenberger, Karin; Formann, Elisabeth; Staufer, Katharina; Steindl-Munda, Petra

2008-08-01

This analysis reports the rate of sustained virological response (SVR) in patients infected with hepatitis C virus (HCV) genotype 1 or 4 who were assigned to 24 weeks of treatment with pegylated interferon (peginterferon) alfa-2a 180 mug/wk plus ribavirin 1000/1200 mg/day after achieving a rapid virological response (RVR; HCV RNA level <50 IU/mL) at week 4 in a prospective trial investigating response-guided therapy. Non-RVR patients with an early virological response were randomized to 48 or 72 weeks of therapy (this is a still-ongoing trial). A total of 150 of 516 patients (29%) had an RVR, 143 of whom completed 24 weeks of treatment. Younger patients, leaner patients, and those with an HCV RNA level

Increased pathological complete response rate after a long-term neoadjuvant letrozole treatment in postmenopausal oestrogen and/or progesterone receptor-positive breast cancer

PubMed Central

Allevi, G; Strina, C; Andreis, D; Zanoni, V; Bazzola, L; Bonardi, S; Foroni, C; Milani, M; Cappelletti, M R; Gussago, F; Aguggini, S; Giardini, R; Martinotti, M; Fox, S B; Harris, A L; Bottini, A; Berruti, A; Generali, D

2013-01-01

Background: The objective of this study was to determine the optimal scheduling of 2.5 mg daily letrozole in neoadjuvant breast cancer patients to obtain pathological complete response (pathCR) and assess Ki-67 expression as an early predictor of response. Patients and methods: This single institution study comprised 120 oestrogen receptor (ER)-positive postmenopausal women with primary breast cancer (clinical stage ⩾T2, N0–1), from three sequential cohorts (cohort A of 40, cohort B of 40 and cohort C of 40 patients, respectively) based on different duration of the neoadjuvant letrozole. Biological markers such as ER, progesterone receptor, HER2 and Ki-67 expression were tested at diagnosis and at definitive surgery. Results: A total of 89 patients (75.4%) achieved an objective response with 44 (37.3%) clinical CRs and 45 (38.1%) partial responses. The clinical CRs were significantly observed in cohort C (23 out of 40 patients, 57.5%) and B (16 out of 38 patients, 42.1%) compared with cohort A (5 out of 40 patients, 12.5%) (P-value for trend <0.001). Letrozole induced a similar significant reduction in Ki-67 index after treatment in all cohorts. The pathCR rate was significantly more frequent in cohort C (7 out of 40 patients, 17.5%) than in cohort A (1 out of 40 patients, 2.5%) and B (2 out of 40 patients, 5.0%) (P-value for trend <0.04). Conclusion: One-year neoadjuvant letrozole therapy leads to a higher pathCR rate and may be the optimal length of drug exposure. PMID:23579222

Phase II study of capecitabine (Xeloda (registered) ) and concomitant boost radiotherapy in patients with locally advanced rectal cancer

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

Krishnan, Sunil; Janjan, Nora A.; Skibber, John M.

2006-11-01

Purpose: The aim of this study was to determine the efficacy of capecitabine (Xeloda (registered) ), an oral fluoropyrimidine, as a radiosensitizer in the neoadjuvant treatment of locally advanced rectal cancer (LARC). Methods and Materials: We conducted a phase II study of capecitabine (825 mg/m{sup 2} orally, twice daily continuous) with radiotherapy (52.5 Gy/30 fractions to the primary tumor and perirectal nodes) in 54 patients with LARC (node-negative {>=}T3 or any node-positive tumor) staged by endoscopic ultrasound (EUS). The primary endpoint was pathologic response rate; secondary endpoints included toxicity profiles and survival parameters. Results: Of the 54 patients (median age,more » 56.7 years; range, 21.3-78.7 years; male:female ratio, 1.7; Eastern Cooperative Oncology Group performance status 0-1: 100%), 51 patients (94%) had T3N0 or T3N1 disease by EUS. Surgery was not performed in 3 patients; 2 of these patients had metastatic disease, and the third patient refused after a complete clinical response. Of the 51 patients evaluable for pathologic response, 9 patients (18%) achieved complete response, and 12 patients (24%) had microscopic residual disease (<10% viable cells). In addition, 26 patients of all 54 patients (51%) achieved T-downstaging, and 15 patients of 29 patients (52%) achieved N-downstaging. Grade 3/4 toxicities were radiation dermatitis (9%) and diarrhea (2%). Sphincter preservation rate for tumor {<=}5 cm from the anal verge was 67% (18/27). Conclusion: This regimen of radiotherapy plus capecitabine is well tolerated and is more convenient than protracted venous infusion of 5-FU. The pathologic response rate is comparable to our previous experience using protracted venous infusion 5-FU for LARC.« less

Thermotolerance and heat acclimation may share a common mechanism in humans

PubMed Central

Gillum, Trevor; Dokladny, Karol; Bedrick, Edward; Schneider, Suzanne; Moseley, Pope

2011-01-01

Thermotolerance and heat acclimation are key adaptation processes that have been hitherto viewed as separate phenomena. Here, we provide evidence that these processes may share a common basis, as both may potentially be governed by the heat shock response. We evaluated the effects of a heat shock response-inhibitor (quercetin; 2,000 mg/day) on established markers of thermotolerance [gastrointestinal barrier permeability, plasma TNF-α, IL-6, and IL-10 concentrations, and leukocyte heat shock protein 70 (HSP70) content]. Heat acclimation reduced body temperatures, heart rate, and physiological strain during exercise/heat stress) in male subjects (n = 8) completing a 7-day heat acclimation protocol. These same subjects completed an identical protocol under placebo supplementation (placebo). Gastrointestinal barrier permeability and TNF-α were increased on the 1st day of exercise/heat stress in quercetin; no differences in these variables were reported in placebo. Exercise HSP70 responses were increased, and plasma cytokines (IL-6, IL-10) were decreased on the 7th day of heat acclimation in placebo; with concomitant reductions in exercise body temperatures, heart rate, and physiological strain. In contrast, gastrointestinal barrier permeability remained elevated, HSP70 was not increased, and IL-6, IL-10, and exercise body temperatures were not reduced on the 7th day of heat acclimation in quercetin. While exercise heart rate and physiological strain were reduced in quercetin, this occurred later in exercise than with placebo. Consistent with the concept that thermotolerance and heat acclimation are related through the heat shock response, repeated exercise/heat stress increases cytoprotective HSP70 and reduces circulating cytokines, contributing to reductions in cellular and systemic markers of heat strain. Exercising under a heat shock response-inhibitor prevents both cellular and systemic heat adaptations. PMID:21613575

Facilitating comparative effectiveness research in cancer genomics: evaluating stakeholder perceptions of the engagement process.

PubMed

Deverka, Patricia A; Lavallee, Danielle C; Desai, Priyanka J; Armstrong, Joanne; Gorman, Mark; Hole-Curry, Leah; O'Leary, James; Ruffner, B W; Watkins, John; Veenstra, David L; Baker, Laurence H; Unger, Joseph M; Ramsey, Scott D

2012-07-01

The Center for Comparative Effectiveness Research in Cancer Genomics completed a 2-year stakeholder-guided process for the prioritization of genomic tests for comparative effectiveness research studies. We sought to evaluate the effectiveness of engagement procedures in achieving project goals and to identify opportunities for future improvements. The evaluation included an online questionnaire, one-on-one telephone interviews and facilitated discussion. Responses to the online questionnaire were tabulated for descriptive purposes, while transcripts from key informant interviews were analyzed using a directed content analysis approach. A total of 11 out of 13 stakeholders completed both the online questionnaire and interview process, while nine participated in the facilitated discussion. Eighty-nine percent of questionnaire items received overall ratings of agree or strongly agree; 11% of responses were rated as neutral with the exception of a single rating of disagreement with an item regarding the clarity of how stakeholder input was incorporated into project decisions. Recommendations for future improvement included developing standard recruitment practices, role descriptions and processes for improved communication with clinical and comparative effectiveness research investigators. Evaluation of the stakeholder engagement process provided constructive feedback for future improvements and should be routinely conducted to ensure maximal effectiveness of stakeholder involvement.

Heart Rate Response to a Timed Walk & Cardiovascular Outcomes in Older Adults: The Cardiovascular Health Study

PubMed Central

Girotra, Saket; Kitzman, Dalane W.; Kop, Willem J.; Stein, Phyllis K.; Gottdiener, John S.; Mukamal, Kenneth J.

2012-01-01

OBJECTIVES To determine the relationship between heart rate response during low-grade physical exertion (six-minute walk) with mortality and adverse cardiovascular outcomes in the elderly. METHODS Participants in the Cardiovascular Health Study, who completed a six-minute walk test, were included. We used delta heart rate (difference between post-walk heart rate and resting heart rate) as a measure of chronotropic response and examined its association with 1) all-cause mortality and 2) incident coronary heart disease (CHD) event, using multivariable Cox regression models. RESULTS We included 2224 participants (mean age 77±4 years; 60% women, 85% white). The average delta heart rate was 26 beats/min. Participants in the lowest tertile of delta heart rate (<20 beats/min) had higher risk-adjusted mortality (hazard ratio [HR] 1.18; 95% confidence interval [CI][1.00, 1.40]) and incident CHD (HR 1.37; 95% CI[1.05, 1.78]) compared to subjects in the highest tertile (≥30 beats/min), with a significant linear trend across tertiles (P for trend <0.05 for both outcomes). This relationship was not significant after adjustment for distance walked. CONCLUSION Impaired chronotropic response during six-minute walk test was associated with an increased risk of mortality and incident CHD among the elderly. This association was attenuated after adjusting for distance walked. PMID:22722364

Significant variations in nutritional supplementation amongst neonates in the United Kingdom.

PubMed

Gordon, Morris; Isaji, Sahira; Tyacke, Fiona

2016-08-08

To ascertain United Kingdom adherence to European society of Paediatric Gastroenterology, Hepatology and Nutrition guidance (ESPGHAN). A national cross sectional questionnaire study of neonatal units across England was completed between January and March 2014. All 174 units in the country were attempted to be contacted to complete a telephone survey. This included all level 1, 2 and 3 units. They were initially contacted by phone and asking any senior member of the team about their current practice and procedures. The first ten telephone interviews were completed with two researchers present to ensure consistency of approach. If no response was received or no details were available, one further attempt was made to contact the unit. The results were recorded in a proforma and then collated and entered into a spreadsheet for analysis. Comparison to United Kingdom adherence to ESPGHAN guidance was completed. Response rate was 53%. There was variation in use of all supplements. The survey collected data from 91 neonatal units (53% response rate). It was found that 10% of neonatal units had no fixed policy on supplements. The protocols regarding supplementation involved predominantly folic acid, vitamin A, vitamin D and iron, with much variation in doses and regimens. The criteria for prescribing supplements was largely based on age (47%) with only 7% using a weight targets to initiate supplements. Summary data regarding the appropriateness of each nutritional supplement for a variety of different weights are presented, as well as comparison to ESPGHAN guidance which suggests issues with both underdoing of Breast Fed infants and overdosing of infants on several artificial formulas which already contain significant amounts of these nutritional elements. There is significant heterogeneity in neonatal policies when prescribing supplements to neonates. National policies which take international guidance into account are recommended.

Neoadjuvant Bevacizumab, Oxaliplatin, 5-Fluorouracil, and Radiation for Rectal Cancer

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

Dipetrillo, Tom; Pricolo, Victor; Lagares-Garcia, Jorge

Purpose: To evaluate the feasibility and pathologic complete response rate of induction bevacizumab + modified infusional fluorouracil, leucovorin, and oxaliplatin (FOLFOX) 6 regimen followed by concurrent bevacizumab, oxaliplatin, continuous infusion 5-fluorouracil (5-FU), and radiation for patients with rectal cancer. Methods and Materials: Eligible patients received 1 month of induction bevacizumab and mFOLFOX6. Patients then received 50.4 Gy of radiation and concurrent bevacizumab (5 mg/kg on Days 1, 15, and 29), oxaliplatin (50 mg/m{sup 2}/week for 6 weeks), and continuous infusion 5-FU (200 mg/m{sup 2}/day). Because of gastrointestinal toxicity, the oxaliplatin dose was reduced to 40 mg/m{sup 2}/week. Resection was performedmore » 4-8 weeks after the completion of chemoradiation. Results: The trial was terminated early because of toxicity after 26 eligible patients were treated. Only 1 patient had significant toxicity (arrhythmia) during induction treatment and was removed from the study. During chemoradiation, Grade 3/4 toxicity was experienced by 19 of 25 patients (76%). The most common Grade 3/4 toxicities were diarrhea, neutropenia, and pain. Five of 25 patients (20%) had a complete pathologic response. Nine of 25 patients (36%) developed postoperative complications including infection (n = 4), delayed healing (n = 3), leak/abscess (n = 2), sterile fluid collection (n = 2), ischemic colonic reservoir (n = 1), and fistula (n = 1). Conclusions: Concurrent oxaliplatin, bevacizumab, continuous infusion 5-FU, and radiation causes significant gastrointestinal toxicity. The pathologic complete response rate of this regimen was similar to other fluorouracil chemoradiation regimens. The high incidence of postoperative wound complications is concerning and consistent with other reports utilizing bevacizumab with chemoradiation before major surgical resections.« less

Validation of sentinel lymph node biopsy in breast cancer women N1-N2 with complete axillary response after neoadjuvant chemotherapy. Multicentre study in Tarragona.

PubMed

Carrera, D; de la Flor, M; Galera, J; Amillano, K; Gomez, M; Izquierdo, V; Aguilar, E; López, S; Martínez, M; Martínez, S; Serra, J M; Pérez, M; Martin, L

2016-01-01

The aim of our study was to evaluate sentinel lymph node biopsy as a diagnostic test for assessing the presence of residual metastatic axillary lymph nodes after neoadjuvant chemotherapy, replacing the need for a lymphadenectomy in negative selective lymph node biopsy patients. A multicentre, diagnostic validation study was conducted in the province of Tarragona, on women with T1-T3, N1-N2 breast cancer, who presented with a complete axillary response after neoadjuvant chemotherapy. Study procedures consisted of performing an selective lymph node biopsy followed by lymphadenectomy. A total of 53 women were included in the study. Surgical detection rate was 90.5% (no sentinel node found in 5 patients). Histopathological analysis of the lymphadenectomy showed complete disease regression of axillary nodes in 35.4% (17/48) of the patients, and residual axillary node involvement in 64.6% (31/48) of them. In lymphadenectomy positive patients, 28 had a positive selective lymph node biopsy (true positive), while 3 had a negative selective lymph node biopsy (false negative). Of the 28 true selective lymph node biopsy positives, the sentinel node was the only positive node in 10 cases. All lymphadenectomy negative cases were selective lymph node biopsy negative. These data yield a sensitivity of 93.5%, a false negative rate of 9.7%, and a global test efficiency of 93.7%. Selective lymph node biopsy after chemotherapy in patients with a complete axillary response provides valid and reliable information regarding axillary status after neoadjuvant treatment, and might prevent lymphadenectomy in cases with negative selective lymph node biopsy. Copyright © 2016 Elsevier España, S.L.U. and SEMNIM. All rights reserved.

Within-session responses to high-intensity interval training in spinal cord injury.

PubMed

Astorino, Todd Anthony; Thum, Jacob S

2018-02-01

Completion of high-intensity interval training (HIIT) increases maximal oxygen uptake and health status, yet its feasibility in persons with spinal cord injury is unknown. To compare changes in cardiorespiratory and metabolic variables between two interval training regimes and moderate intensity exercise. Nine adults with spinal cord injury (duration = 6.8 ± 6.2 year) initially underwent determination of peak oxygen uptake. During subsequent sessions, they completed moderate intensity exercise, HIIT, or sprint interval training. Oxygen uptake, heart rate, and blood lactate concentration were measured. Oxygen uptake and heart rate increased (p < 0.05) during both interval training sessions and were similar (p > 0.05) to moderate intensity exercise. Peak oxygen uptake and heart rate were higher (p < 0.05) with HIIT (90% peak oxygen uptake and 99% peak heart rate) and sprint interval training (80% peak oxygen uptake and 96% peak heart rate) versus moderate intensity exercise. Despite a higher intensity and peak cardiorespiratory strain, all participants preferred interval training versus moderate exercise. Examining long-term efficacy and feasibility of interval training in this population is merited, considering that exercise intensity is recognized as the most important variable factor of exercise programming to optimize maximal oxygen uptake. Implications for Rehabilitation Spinal cord injury (SCI) reduces locomotion which impairs voluntary physical activity, typically resulting in a reduction in peak oxygen uptake and enhanced chronic disease risk. In various able-bodied populations, completion of high-intensity interval training (HIIT) has been consistently reported to improve cardiorespiratory fitness and other health-related outcomes, although its efficacy in persons with SCI is poorly understood. Data from this study in 9 men and women with SCI show similar changes in oxygen uptake and heart in response to HIIT compared to a prolonged bout of aerobic exercise, although peak values were higher in response to HIIT. Due to the higher peak metabolic strain induced by HIIT as well as universal preference for this modality versus aerobic exercise as reported in this study, further work testing utility of HIIT in this population is merited.

Thrombotic thrombocytopenic purpura-hemolytic uremic syndrome (TTP-HUS): a 24-year clinical experience with 178 patients

PubMed Central

Levandovsky, Mark; Harvey, Danielle; Lara, Primo; Wun, Ted

2008-01-01

Background Thrombotic thrombocytopenic purpura and the hemolytic uremic syndrome (TTP-HUS) are related and uncommon disorders with a high fatality and complication rate if untreated. Plasma exchange therapy has been shown to produce high response rates and improve survival in patients with many forms of TTP-HUS. We performed a retrospective cohort study of 178 consecutively treated patients with TTP-HUS and analyzed whether clinical or laboratory characteristics could predict for important short- and long-term outcome measures. Results Overall 30-day mortality was 16% (n = 27). 171 patients (96%) received plasma exchange as the principal treatment, with a mean of 8 exchanges and a mean cumulative infused volume of 42 ± 71 L of fresh frozen plasma. The rate of complete response was 65% or 55% depending on whether this was defined by a platelet count of 100,000/μl or 150,000/μl, respectively. The rate of relapse was 18%. The Clinical Severity Score did not predict for 30-day mortality or relapse. The time to complete response did not predict for relapse. Renal insufficiency at presentation was associated with a decreased risk of relapse, with each unit increase in serum creatinine associated with a 40% decreased odds of relapse. 72% of our cohort had an idiopathic TTP-sporadic HUS, while 17% had an underlying cancer, received a solid organ transplant or were treated with a mitomycin-based therapy. The estimated overall 5-year survival was 55% and was significantly better in those without serious underlying conditions. Conclusion Plasma exchange therapy produced both high response and survival rates in this large cohort of patients with TTP-HUS. The Clinical Severity Score did not predict for 30-day mortality or relapse, contrary to our previous findings. Interestingly, the presence of renal insufficiency was associated with a decreased risk of relapse. The most important predictor of mortality was the presence or absence of a serious underlying disorder. PMID:19046460

[Response and prognosis of patients with multiple myeloma induced by PAD/TAD].

PubMed

Zeng, Tianmei; He, Haiyan; Shi, Haotian; Xi, Hao; Du, Juan; Zhang, Chunyang; Jiang, Hua; Fu, Weijun; Zhou, Fan; Hou, Jian

2015-03-17

To evaluate the impact of cytogenetic grouping and autologous stem cell transplantation on the prognosis of patients with multiple myeloma (MM) induced by PAD (velcade+epirubicin+dexamethasone) and TAD (thalidomide+epirubicin+dexamethasone). A total of 191 patients with a definite diagnosis of MM were enrolled from May 2008 to December 2013 into this prospective study. They were non-randomly induced by PAD (n = 132) or TAD (n = 59) plus autologous stem cell transplantation or chemotherapy. Response and survival rates were also analyzed between two groups. The overall response rates of PAD and TAD groups were 84.4% (108/128) and 69.5% (41/59) (P = 0.011) respectively. The very good partial remission (VGPR) rates were 70.3% (90/128) and 32.2% (19/59) (P < 0.001) and near complete remission/complete remission (nCR/CR) rates 68.0% (87/128) and 25.4% (15/59) respectively (P < 0.001). Both progression-free survival (PFS) and overall survival (OS) showed no significant inter-group difference (P = 0.223, 0.989). The survival analysis of PAD group showed that FISH high-risk group had shorter PFS and OS than FISH low-risk group (15.2 vs 19.1 months for PFS, P = 0.098; 41.2 months vs non-attaining for OS, P = 0.017). In FISH high-risk group, patients consolidated with autologous stem cell transplantation showed longer PFS than those with chemotherapy (17.8 vs 14.6 months, P = 0.029) while the OS showed no difference (P = 0.840). In FISH low-risk group, no difference were observed in PFS and OS between patients with consolidation therapies alone (P = 0.131, 0.294). The response rates are higher in patients induced by PAD than by TAD. After PAD induction, cytogenetic grouping may further distinguish the prognosis of MM patients. For FISH high-risk patients, their PFS is prolonged by autologous stem cell transplantation.

The relaxation response resiliency program (3RP) in patients with neurofibromatosis 1, neurofibromatosis 2, and schwannomatosis: results from a pilot study.

PubMed

Vranceanu, Ana-Maria; Merker, Vanessa L; Plotkin, Scott R; Park, Elyse R

2014-10-01

NF1, NF2, and Schwannomatosis are incurable tumor suppressor syndromes associated with poor quality of life. The aim of this study was to determine the feasibility, acceptability, and preliminary efficacy of an NF adapted, 8-week group mind body skills based intervention, the relaxation response resiliency program (3RP) aimed at improving resiliency and increasing satisfaction with life. Patients seen at MGH's Neurofibromatosis Clinic were offered participation if they described difficulties coping to a treating physician. Participants completed measures of life satisfaction, resiliency, stress, mood, lifestyle, pain, post-traumatic growth and mindfulness at baseline and after completing the 3RP program. The intervention had relative feasible enrollment rate (48% rate, 32 out of 67 of patients signing the informed consent form). However, out of the 32 patients who signed the informed consent, only 20 started the study (62.5%) and only 16 completed it (50%), suggesting problems with feasibility. The main reason cited for non-participation was burden of travel to the clinic. The intervention was highly acceptable, as evidenced by an 80% completion rate (16/20). Paired t tests showed significant improvement in resiliency, satisfaction with life, depression, stress, anxiety, mindfulness and post traumatic growth, with effect sizes ranging from 0.73-1.33. There was a trend for significance for improvement in somatization and sleepiness (p = 0.06), with effect sizes of 0.54-0.92 respectively. Statistically nonsignificant improvement was observed in all other measures, with effect sizes small to medium. In sum, the 3RP was found to be relatively feasible, highly acceptable and preliminary efficacious in decreasing symptom burden in this population, supporting the need of a randomized controlled trial.

A systematic review of the safety and efficacy of aerobic exercise during cytotoxic chemotherapy treatment.

PubMed

Cave, J; Paschalis, A; Huang, C Y; West, M; Copson, E; Jack, S; Grocott, M P W

2018-06-24

Aerobic exercise improves prognosis and quality of life (QoL) following completion of chemotherapy. However, the safety and efficacy of aerobic exercise during chemotherapy is less certain. A systematic review was performed of randomised trials of adult patients undergoing chemotherapy, comparing an exercise intervention with standard care. From 253 abstracts screened, 33 unique trials were appraised in accordance with PRISMA guidance, including 3257 patients. Interventions included walking, jogging or cycling, and 23 were of moderate intensity (50-80% maximum heart rate). Aerobic exercise improved, or at least maintained fitness during chemotherapy. Moderately intense exercise, up to 70-80% of maximum heart rate, was safe. Any reported adverse effects of exercise were mild and self-limiting, but reporting was inconsistent. Adherence was good (median 72%). Exercise improved QoL and physical functioning, with earlier return to work. Two out of four studies reported improved chemotherapy completion rates. Four out of six studies reported reduced chemotherapy toxicity. There was no evidence that exercise reduced myelosuppression or improved response rate or survival. Exercise during chemotherapy is safe and should be encouraged because of beneficial effects on QoL and physical functioning. More research is required to determine the impact on chemotherapy completion rates and prognosis.

Reducing Weekend Litter (and Improving RA-Resident Interactions) in a College Residence Hall.

ERIC Educational Resources Information Center

Luyben, Paul D.; And Others

1984-01-01

Investigated the effectiveness of a litter reduction program, consisting of group assignment of responsibility and a token reward system, on weekend litter rates in college residence halls. Results indicated procedure was completely effective, with litter reduced to zero in all settings. (BL)

The cost-effectiveness of cash versus lottery incentives for a web-based, stated-preference community survey.

PubMed

Gajic, Aleksandra; Cameron, David; Hurley, Jeremiah

2012-12-01

We present the results of a randomized experiment to test the effectiveness and cost-effectiveness of response incentives for a stated-preference survey of a general community population. The survey was administered using a mixed-mode approach, in which community members were invited to participate using a traditional mailed letter using contact information for a representative sample of the community; but individuals completed the survey via the web, which exploited the advantages of electronic capture. Individuals were randomized to four incentive groups: (a) no incentive, (b) prepaid cash incentive ($2), (c) a low lottery (10 prizes of $25) and (d) a high lottery (2 prizes of $250). Letters of invitation were mailed to 3,000 individuals. In total, 405 individuals (14.4%) contacted the website and 277 (9.8%) provided complete responses. The prepaid cash incentive generated the highest contact and response rates (23.3 and 17.3%, respectively), and no incentive generated the lowest (9.1 and 5.7%, respectively). The high lottery, however, was the most cost-effective incentive for obtaining completed surveys: compared with no incentive, the incremental cost-effectiveness ratio (ICER) per completed survey for high lottery was $13.89; for prepaid cash, the ICER was $18.29. This finding suggests that the preferred response incentive for community-based, stated-preference surveys is a lottery with a small number of large prizes.

Efficacy and Biological Correlates of Response in a Phase 2 Study of Venetoclax Monotherapy in Patients with Acute Myelogenous Leukemia

PubMed Central

Konopleva, Marina; Pollyea, Daniel A.; Potluri, Jalaja; Chyla, Brenda; Hogdal, Leah; Busman, Todd; McKeegan, Evelyn; Salem, Ahmed Hamed; Zhu, Ming; Ricker, Justin L.; Blum, William; DiNardo, Courtney D.; Kadia, Tapan; Dunbar, Martin; Kirby, Rachel; Falotico, Nancy; Leverson, Joel; Humerickhouse, Rod; Mabry, Mack; Stone, Richard; Kantarjian, Hagop; Letai, Anthony

2017-01-01

We present a phase 2, single-arm study evaluating 800 mg daily venetoclax, a highly selective, oral small-molecule B-cell leukemia/lymphoma-2 (BCL-2) inhibitor in patients with high-risk relapsed/refractory acute myelogenous leukemia (AML) or unfit for intensive chemotherapy. Responses were evaluated following revised International Working Group (IWG) criteria. The overall response rate was 19%; an additional 19% of patients demonstrated anti-leukemic activity not meeting IWG criteria (partial bone marrow response and incomplete hematologic recovery). Twelve (38%) patients had isocitrate dehydrogenase 1/2 mutations, of whom 4 (33%) achieved complete response/complete response with incomplete blood count recovery. Six (19%) patients had BCL-2–sensitive protein index at screening, which correlated with time on study. BH3 profiling was consistent with on-target BCL-2 inhibition and identified potential resistance mechanisms. Common adverse events included nausea, diarrhea and vomiting (all grades), and febrile neutropenia and hypokalemia (grade 3/4). Venetoclax demonstrated activity and acceptable tolerability in patients with AML and adverse features. PMID:27520294

Adoptive Cell Therapy for the Treatment of Patients with Metastatic Melanoma

PubMed Central

Rosenberg, Steven A.; Dudley, Mark E.

2012-01-01

Adoptive cell therapy (ACT) is the best available treatment for patients with metastatic melanoma. In a recent series of three consecutive clinical trials using increasing lymphodepletion prior to infusion of autologous tumor infiltrating lymphocytes (TIL), objective response rates between 49% and 72% were seen. Persistence of infused cells in the circulation at one month was highly correlated with anti-tumor response as was the mean telomere length of the cells infused and the number of CD8+ CD27+ cells infused. Responses occur at all sites and appear to be durable with many patients in ongoing response beyond three years. In the most recent trial of 25 patients receiving maximum lymphodepletion, seven of the 25 patients (28%) achieved a complete response. Of the 12 patients in the three trials who achieved a complete response all but one are ongong between 18 and 75 months. We recently demonstrated that ACT using autologous lymphocytes genetically modified to express anti-tumor T cell receptors can mediate tumor regression and this approach is now being applied to patients with common epithelial cancers. PMID:19304471

Topotecan-Vincristine-Doxorubicin in Stage 4 High-Risk Neuroblastoma Patients Failing to Achieve a Complete Metastatic Response to Rapid COJEC: A SIOPEN Study.

PubMed

Amoroso, Loredana; Erminio, Giovanni; Makin, Guy; Pearson, Andrew D J; Brock, Penelope; Valteau-Couanet, Dominique; Castel, Victoria; Pasquet, Marlène; Laureys, Genevieve; Thomas, Caroline; Luksch, Roberto; Ladenstein, Ruth; Haupt, Riccardo; Garaventa, Alberto

2018-01-01

Metastatic response to induction therapy for high-risk neuroblastoma is a prognostic factor. In the International Society of Paediatric Oncology Europe Neuroblastoma (SIOPEN) HR-NBL-1 protocol, only patients with metastatic complete response (CR) or partial response (PR) with ≤ three abnormal skeletal areas on iodine 123-metaiodobenzylguanidine ([ 123 I]mIBG) scintigraphy and no bone marrow disease proceed to high dose therapy (HDT). In this study, topotecan-vincristine-doxorubicin (TVD) was evaluated in patients failing to achieve these criteria, with the aim of improving the metastatic response rate. Patients with metastatic high-risk neuroblastoma who had not achieved the SIOPEN criteria for HDT after induction received two courses of topotecan 1.5 mg/m 2 /day for 5 days, followed by a 48-hour infusion of vincristine, 2 mg/m 2 , and doxorubicin, 45 mg/m 2 . Sixty-three patients were eligible and evaluable. Following two courses of TVD, four (6.4%) patients had an overall CR, while 28 (44.4%) had a PR with a combined response rate of 50.8% (95% confidence interval [CI], 37.9 to 63.6). Of these, 23 patients achieved a metastatic CR or a PR with ≤ 3 mIBG skeletal areas and no bone marrow disease (36.5%; 95% CI, 24.7 to 49.6) and were eligible to receive HDT. Toxicity was mostly haematological, affecting 106 of the 126 courses (84.1%; 95% CI, 76.5 to 90.0), and dose reduction was necessary in six patients. Stomatitis was the second most common nonhematological toxicity, occurring in 20 patients (31.7%). TVD was effective in improving the response rate of high-risk neuroblastoma patients after induction with COJEC enabling them to proceed to HDT. However, the long-term benefits of TVD needs to be determined in randomized clinical trials.

Topotecan-Vincristine-Doxorubicin in Stage 4 High-Risk Neuroblastoma Patients Failing to Achieve a Complete Metastatic Response to Rapid COJEC: A SIOPEN Study

PubMed Central

Amoroso, Loredana; Erminio, Giovanni; Makin, Guy; Pearson, Andrew D. J.; Brock, Penelope; Valteau-Couanet, Dominique; Castel, Victoria; Pasquet, Marlène; Laureys, Genevieve; Thomas, Caroline; Luksch, Roberto; Ladenstein, Ruth; Haupt, Riccardo; Garaventa, Alberto

2018-01-01

Purpose Metastatic response to induction therapy for high-risk neuroblastoma is a prognostic factor. In the International Society of Paediatric Oncology Europe Neuroblastoma (SIOPEN) HR-NBL-1 protocol, only patients with metastatic complete response (CR) or partial response (PR) with ≤ three abnormal skeletal areas on iodine 123-metaiodobenzylguanidine ([123I]mIBG) scintigraphy and no bone marrow disease proceed to high dose therapy (HDT). In this study, topotecan-vincristine-doxorubicin (TVD) was evaluated in patients failing to achieve these criteria, with the aim of improving the metastatic response rate. Materials and Methods Patients with metastatic high-risk neuroblastoma who had not achieved the SIOPEN criteria for HDT after induction received two courses of topotecan 1.5 mg/m2/day for 5 days, followed by a 48-hour infusion of vincristine, 2 mg/m2, and doxorubicin, 45 mg/m2. Results Sixty-three patients were eligible and evaluable. Following two courses of TVD, four (6.4%) patients had an overall CR, while 28 (44.4%) had a PR with a combined response rate of 50.8% (95% confidence interval [CI], 37.9 to 63.6). Of these, 23 patients achieved a metastatic CR or a PR with ≤ 3 mIBG skeletal areas and no bone marrow disease (36.5%; 95% CI, 24.7 to 49.6) and were eligible to receive HDT. Toxicity was mostly haematological, affecting 106 of the 126 courses (84.1%; 95% CI, 76.5 to 90.0), and dose reduction was necessary in six patients. Stomatitis was the second most common nonhematological toxicity, occurring in 20 patients (31.7%). Conclusion TVD was effective in improving the response rate of high-risk neuroblastoma patients after induction with COJEC enabling them to proceed to HDT. However, the long-term benefits of TVD needs to be determined in randomized clinical trials. PMID:28324923

Acute Anxiety Predicts Components of the Cold Shock Response on Cold Water Immersion: Toward an Integrated Psychophysiological Model of Acute Cold Water Survival

PubMed Central

Barwood, Martin J.; Corbett, Jo; Massey, Heather; McMorris, Terry; Tipton, Mike; Wagstaff, Christopher R. D.

2018-01-01

Introduction: Drowning is a leading cause of accidental death. In cold-water, sudden skin cooling triggers the life-threatening cold shock response (CSR). The CSR comprises tachycardia, peripheral vasoconstriction, hypertension, inspiratory gasp, and hyperventilation with the hyperventilatory component inducing hypocapnia and increasing risk of aspirating water to the lungs. Some CSR components can be reduced by habituation (i.e., reduced response to stimulus of same magnitude) induced by 3–5 short cold-water immersions (CWI). However, high levels of acute anxiety, a plausible emotion on CWI: magnifies the CSR in unhabituated participants, reverses habituated components of the CSR and prevents/delays habituation when high levels of anxiety are experienced concurrent to immersions suggesting anxiety is integral to the CSR. Purpose: To examine the predictive relationship that prior ratings of acute anxiety have with the CSR. Secondly, to examine whether anxiety ratings correlated with components of the CSR during immersion before and after induction of habituation. Methods: Forty-eight unhabituated participants completed one (CON1) 7-min immersion in to cold water (15°C). Of that cohort, twenty-five completed four further CWIs that would ordinarily induce CSR habituation. They then completed two counter-balanced immersions where anxiety levels were increased (CWI-ANX) or were not manipulated (CON2). Acute anxiety and the cardiorespiratory responses (cardiac frequency [fc], respiratory frequency [fR], tidal volume [VT], minute ventilation [E]) were measured. Multiple regression was used to identify components of the CSR from the most life-threatening period of immersion (1st minute) predicted by the anxiety rating prior to immersion. Relationships between anxiety rating and CSR components during immersion were assessed by correlation. Results: Anxiety rating predicted the fc component of the CSR in unhabituated participants (CON1; p < 0.05, r = 0.536, r2= 0.190). After habituation immersions (i.e., cohort 2), anxiety rating predicted the fR component of the CSR when anxiety levels were lowered (CON2; p < 0.05, r = 0.566, r2= 0.320) but predicted the fc component of the CSR (p < 0.05, r = 0.518, r2= 0.197) when anxiety was increased suggesting different drivers of the CSR when anxiety levels were manipulated; correlation data supported these relationships. Discussion: Acute anxiety is integral to the CSR before and after habituation. We offer a new integrated model including neuroanatomical, perceptual and attentional components of the CSR to explain these data. PMID:29695988

Acute Anxiety Predicts Components of the Cold Shock Response on Cold Water Immersion: Toward an Integrated Psychophysiological Model of Acute Cold Water Survival.

PubMed

Barwood, Martin J; Corbett, Jo; Massey, Heather; McMorris, Terry; Tipton, Mike; Wagstaff, Christopher R D

2018-01-01

Introduction: Drowning is a leading cause of accidental death. In cold-water, sudden skin cooling triggers the life-threatening cold shock response (CSR). The CSR comprises tachycardia, peripheral vasoconstriction, hypertension, inspiratory gasp, and hyperventilation with the hyperventilatory component inducing hypocapnia and increasing risk of aspirating water to the lungs. Some CSR components can be reduced by habituation (i.e., reduced response to stimulus of same magnitude) induced by 3-5 short cold-water immersions (CWI). However, high levels of acute anxiety, a plausible emotion on CWI: magnifies the CSR in unhabituated participants, reverses habituated components of the CSR and prevents/delays habituation when high levels of anxiety are experienced concurrent to immersions suggesting anxiety is integral to the CSR. Purpose: To examine the predictive relationship that prior ratings of acute anxiety have with the CSR. Secondly, to examine whether anxiety ratings correlated with components of the CSR during immersion before and after induction of habituation. Methods: Forty-eight unhabituated participants completed one (CON1) 7-min immersion in to cold water (15°C). Of that cohort, twenty-five completed four further CWIs that would ordinarily induce CSR habituation. They then completed two counter-balanced immersions where anxiety levels were increased (CWI-ANX) or were not manipulated (CON2). Acute anxiety and the cardiorespiratory responses (cardiac frequency [ f c ], respiratory frequency [ f R ], tidal volume [ V T ], minute ventilation [ E ]) were measured. Multiple regression was used to identify components of the CSR from the most life-threatening period of immersion (1 st minute) predicted by the anxiety rating prior to immersion. Relationships between anxiety rating and CSR components during immersion were assessed by correlation. Results: Anxiety rating predicted the f c component of the CSR in unhabituated participants (CON1; p < 0.05, r = 0.536, r 2 = 0.190). After habituation immersions (i.e., cohort 2), anxiety rating predicted the f R component of the CSR when anxiety levels were lowered (CON2; p < 0.05, r = 0.566, r 2 = 0.320) but predicted the f c component of the CSR ( p < 0.05, r = 0.518, r 2 = 0.197) when anxiety was increased suggesting different drivers of the CSR when anxiety levels were manipulated; correlation data supported these relationships. Discussion: Acute anxiety is integral to the CSR before and after habituation. We offer a new integrated model including neuroanatomical, perceptual and attentional components of the CSR to explain these data.

Nonoperative management of atypical endometrial hyperplasia and grade 1 endometrial cancer with the levonorgestrel intrauterine device in medically ill post-menopausal women.

PubMed

Baker, William D; Pierce, Stuart R; Mills, Anne M; Gehrig, Paola A; Duska, Linda R

2017-07-01

To assess the endometrial response rates to treatment with the levonorgestrel intrauterine device in post-menopausal women with atypical hyperplasia/endometrial intraepithelial neoplasia and grade 1 endometrioid (AH/EC) endometrial carcinoma who are not surgical candidates. Chart review was undertaken of patients with AH/EC who underwent levonorgestrel intrauterine device insertion by a gynecologic oncologist within two academic health systems between 2002 and 2013. When available, tissue blocks were evaluated with immunohistochemical staining for progesterone receptor expression. A total of 41 patients received treatment for AH/EC with the levonorgestrel intrauterine device. Follow up sufficient to assess response occurred in 36 women (88%). Complete response was documented in 18 of 36 women (50%), no response in 8 patients (22%), partial response in 3 women (8%) and progression of disease in 7 patients (19%). Four of 18 patients with complete response (22%) later experienced relapse of hyperplasia or cancer. Four patients (10%) died during the study period: none had evidence of metastatic disease and 1 of the 4 woman died of perioperative complications following hysterectomy for stage I disease. Patients responding to treatment had significantly lower progesterone receptor expression on post-treatment biopsies. Intrauterine levonorgestrel is a viable treatment option for post-menopausal women with AH/EC who are poor candidates for standard surgical management. The response rate in this series is similar to published reports in premenopausal patients and includes cases of disease recurrence following conversion to benign endometrium. Copyright © 2017 Elsevier Inc. All rights reserved.

Watchkeeping Studies on a Nuclear Submarine

DTIC Science & Technology

1975-07-01

degree of variability in performance occurs in response to the persisting diurnal rhythms, whereas in the latter, a degree of adaptation of these...charge of each of the three watches of 4 ratings was n’-de responsible for ensuring that these forms were correctly completed, T. whole ,erption was...of some 20-25 hours, the exact amour ,, depending on the individual’s personal sleep requirements. The 3-day sleep totals for each subject were

The role of working memory and divided attention in metaphor interpretation.

PubMed

Iskandar, Sam; Baird, Anne D

2014-10-01

Although several types of figurative language exist, neuropsychological tests of non-literal language have focused on proverbs. Metaphors in the form X is (a) Y (e.g., The body's immunological response is a battle against disease.) place a lower demand on language skills and are more easily manipulated for novelty than proverbs. Forty healthy participants completed the Metaphor Interpretation Test (developed by the authors). The task includes 20 items chosen from a list of metaphors that were rated on several scales (e.g. imagery, aptness) in a study by Katz et al. (Metaphor Symb Act 3(4):191-214, 1988). Participants were asked to rate the familiarity and provide an explanation of each metaphor. A scoring system was developed to categorize answers into: abstract complete (AC), abstract partial (AP), concrete (CT), and other/unrelated (OT) types. Participants also completed short-term memory and divided attention tests. Overall, participants produced 56 % AC, 25.38 % AP, 7.88 % CT, and 10.88 % OT responses. It was found that a measure of verbal short-term memory span was the best predictor of performance on this task (adjusted R(2) = .369). It appears that short-term memory span, not working memory or divided attention, contributes most to providing abstract responses in explaining metaphors. This is in line with the idea that when one accesses the semantic network associated with a novel metaphor, one must hold this information in mind long enough to search for and link similar cognitive networks.

Bosutinib versus imatinib in newly diagnosed chronic-phase chronic myeloid leukaemia: results from the 24-month follow-up of the BELA trial.

PubMed

Brümmendorf, Tim H; Cortes, Jorge E; de Souza, Cármino Antonio; Guilhot, Francois; Duvillié, Ladan; Pavlov, Dmitri; Gogat, Karïn; Countouriotis, Athena M; Gambacorti-Passerini, Carlo

2015-01-01

Bosutinib is an oral, dual SRC/ABL1 tyrosine kinase inhibitor for resistant/intolerant chronic myeloid leukaemia (CML). We assessed the efficacy and safety of bosutinib 500 mg/d (n = 250) versus imatinib 400 mg/d (n = 252) after >24 months from accrual completion in newly diagnosed chronic phase (CP)-CML (Bosutinib Efficacy and Safety in Newly Diagnosed CML trial [BELA]). Cumulative complete cytogenetic response (CCyR) rates by 24 months were similar (bosutinib, 79%; imatinib, 80%); cumulative major molecular response (MMR) rates were 59% for bosutinib and 49% for imatinib. Responses were durable; 151/197 vs. 172/204 and 125/153 vs. 117/131 responders remained on treatment and maintained CCyR and MMR, respectively. Since the 12-month primary analysis, no new accelerated-/blast-phase transformations occurred with bosutinib; four occurred with imatinib. Early response (BCR-ABL1/ABL1 ≤ 10%, 3 months) was associated with better CCyR and MMR rates by 12 and 24 months (both arms). Gastrointestinal events and liver function test elevations were more common, and neutropenia, musculoskeletal events and oedema were less common with bosutinib. Discontinuations due to adverse events were more common with bosutinib versus imatinib (most commonly alanine aminotransferase elevation: 4% vs. <1%); most occurred within the first 12 months. Cardiovascular adverse events were similar in both arms. Bosutinib continues to demonstrate good efficacy and manageable tolerability in newly diagnosed CP-CML patients. © 2014 The Authors. British Journal of Haematology published by John Wiley & Sons Ltd.

Immunogenicity and safety of a new hexavalent vaccine (DTaP5-IPV-HB-Hib) administered in a mixed primary series schedule with a pentavalent vaccine (DTaP5-IPV-Hib).

PubMed

Martinón-Torres, Federico; Boisnard, Florence; Thomas, Stéphane; Sadorge, Christine; Borrow, Ray

2017-06-27

DTaP5-IPV-HB-Hib vaccine is a fully-liquid, combination hexavalent vaccine. This phase III, open-label, multicentre study conducted in Spain, evaluated the immune response to all DTaP5-IPV-HB-Hib antigens when the vaccine was used in a mixed hexa/penta/hexa primary series. Infants (who had received one dose of hepatitis B vaccine at birth) received a mixed schedule including DTaP5-IPV-HB-Hib (PRP-OMP conjugate) at 2 and 6months of age, DTaP5-IPV-Hib at 4months, meningococcal serogroup C conjugate (MCC) vaccine at 2 and 4months, and routine rotavirus and pneumococcal vaccination. One month post-dose 3 of the mixed schedule, response rates were considered acceptable if the lower bound of the two-sided 95% confidence interval around the post-vaccination response rate was >90% for hepatitis B and >80% for Haemophilus influenzae type b (Hib). Secondary immunogenicity objectives included description of the antibody response to all hexavalent antigens one month after completion of the mixed schedule, and to MCC antigen one month after the second MCC dose. The safety profile after each dose of study vaccine was described. Of 385 healthy infants enrolled, 384 completed the study. The primary objective was achieved for both hepatitis B and Hib; the lower bound of the 2-sided 95% CI of the response rates (97.2% and 99.0%, respectively) were greater than the pre-specified acceptability thresholds. One month post-dose 3 of the mixed schedule, all participants were seroprotected against diphtheria, tetanus and polio. The mixed schedule induced a robust immune response to all hexavalent antigens. The co-administration of the hexavalent vaccine in a mixed schedule with MCC vaccine did not reduce the immune response to vaccine antigens. Vaccines were well tolerated. In conclusion, the acceptability of response rates against Hib and hepatitis B were demonstrated one month post-dose 3 of the mixed schedule; robust immune responses against all other hexavalent antigens were observed. clinicaltrial.gov: NCT01839188; EudraCT: 2012-004221-25. Copyright © 2017 Elsevier Ltd. All rights reserved.

The association of spiritual care providers’ activities with family members’ satisfaction with care after a death in the ICU

PubMed Central

Johnson, Jeffrey R.; Engelberg, Ruth A.; Nielsen, Elizabeth L.; Kross, Erin K.; Smith, Nicholas L.; Hanada, Julie C.; O’Mahoney, Sean K Doll; Curtis, J. Randall

2014-01-01

Objective Spiritual distress is common in the ICU, and spiritual care providers are often called upon to provide care for patients and their families. Our goal was to evaluate the activities spiritual care providers’ conduct to support patients and families, and whether those activities are associated with family satisfaction with ICU care. Design Prospective cohort study. Setting 350-bed, 65-ICU bed tertiary care teaching hospital. Subjects Spiritual care providers and family members of patients who died in the ICU or within 30 hours of transfer from the ICU. Measurements Spiritual care providers completed surveys reporting their activities. Family members completed validated measures of satisfaction with care and satisfaction with spiritual care. Clustered regression was used to assess the association between activities completed by spiritual care providers and family ratings of care. Results Of 494 eligible patients, 275 family members completed surveys (response rate, 56%). Fifty-seven spiritual care providers received surveys relating to 268 patients, completing 285 surveys for 244 patients (response rate, 91%). Spiritual care providers commonly reported activities related to supporting religious and spiritual needs (>=90%) and providing support for family feelings (90%). Discussions about the patient’s wishes for end-of-life care and a greater number of spiritual care activities performed were both associated with increased overall family satisfaction with ICU care (p<0.05). Discussions about a patient’s end-of-life wishes, preparation for a family conference, and total number of activities performed were associated with improved family satisfaction with decision-making in the ICU (p<0.05). Conclusions Spiritual care providers engage in a variety of activities with families of ICU patients; several are associated with increased family satisfaction with ICU care in general and decision-making in the ICU specifically. These findings provide insight into spiritual care provider activities and provide guidance for interventions to improve spiritual care delivered to families of critically ill patients. PMID:24797373

Hydraulic fracturing volume is associated with induced earthquake productivity in the Duvernay play

NASA Astrophysics Data System (ADS)

Schultz, R.; Atkinson, G.; Eaton, D. W.; Gu, Y. J.; Kao, H.

2018-01-01

A sharp increase in the frequency of earthquakes near Fox Creek, Alberta, began in December 2013 in response to hydraulic fracturing. Using a hydraulic fracturing database, we explore relationships between injection parameters and seismicity response. We show that induced earthquakes are associated with completions that used larger injection volumes (104 to 105 cubic meters) and that seismic productivity scales linearly with injection volume. Injection pressure and rate have an insignificant association with seismic response. Further findings suggest that geological factors play a prominent role in seismic productivity, as evidenced by spatial correlations. Together, volume and geological factors account for ~96% of the variability in the induced earthquake rate near Fox Creek. This result is quantified by a seismogenic index–modified frequency-magnitude distribution, providing a framework to forecast induced seismicity.

A pragmatic randomised controlled trial of hydrotherapy and land exercises on overall well being and quality of life in rheumatoid arthritis

PubMed Central

Eversden, Lis; Maggs, Fiona; Nightingale, Peter; Jobanputra, Paresh

2007-01-01

Background Hydrotherapy is highly valued by people with rheumatoid arthritis yet few studies have compared the benefits of exercises in heated water against exercises on land. In particular, data on quality of life is rarely reported. This is especially important because patients treated with hydrotherapy often report an enhanced sense of well-being. We report a randomised controlled trial in which we compared the effects of hydrotherapy with exercises on land on overall response to treatment, physical function and quality of life in patients with rheumatoid arthritis. Methods One hundred and fifteen patients with RA were randomised to receive a weekly 30-minute session of hydrotherapy or similar exercises on land for 6 weeks. Our primary outcome was a self-rated global impression of change – a measure of treatment effect on a 7-point scale ranging from 1(very much worse) to 7 (very much better) assessed immediately on completion of treatment. Secondary outcomes including EuroQol health related quality of life, EuroQol health status valuation, HAQ, 10 metre walk time and pain scores were collected at baseline, after treatment and 3 months later. Binary outcomes were analysed by Fisher's exact test and continuous variables by Wilcoxon or Mann-Whitney tests. Results Baseline characteristics of the two groups were comparable. Significantly more patients treated with hydrotherapy (40/46, 87%) were much better or very much better than the patients treated with land exercise (19/40, 47.5%), p < 0.001 Fisher's exact test. Eleven patients allocated land exercise failed to complete treatment compared with 4 patients allocated hydrotherapy (p = 0.09). Sensitivity analyses confirmed an advantage for hydrotherapy if we assumed non-completers would all not have responded (response rates 70% versus 38%; p < 0.001) or if we assumed that non-completers would have had the same response as completers (response rates 82% versus 55% p = 0.002). Ten metre walk time improved after treatment in both cases (median pre-treatment time for both groups combined 10.9 seconds, post-treatment 9.1 s, and 3 months later 9.6 s). There was however no difference between treatment groups. Similarly there were no significant differences between groups in terms of changes to HAQ, EQ-5D utility score, EQ VAS and pain VAS. Conclusion Patients with RA treated with hydrotherapy are more likely to report feeling much better or very much better than those treated with land exercises immediately on completion of the treatment programme. This perceived benefit was not reflected by differences between groups in 10-metre walk times, functional scores, quality of life measures and pain scores. PMID:17331241

A pragmatic randomised controlled trial of hydrotherapy and land exercises on overall well being and quality of life in rheumatoid arthritis.

PubMed

Eversden, Lis; Maggs, Fiona; Nightingale, Peter; Jobanputra, Paresh

2007-03-01

Hydrotherapy is highly valued by people with rheumatoid arthritis yet few studies have compared the benefits of exercises in heated water against exercises on land. In particular, data on quality of life is rarely reported. This is especially important because patients treated with hydrotherapy often report an enhanced sense of well-being. We report a randomised controlled trial in which we compared the effects of hydrotherapy with exercises on land on overall response to treatment, physical function and quality of life in patients with rheumatoid arthritis. One hundred and fifteen patients with RA were randomised to receive a weekly 30-minute session of hydrotherapy or similar exercises on land for 6 weeks. Our primary outcome was a self-rated global impression of change--a measure of treatment effect on a 7-point scale ranging from 1(very much worse) to 7 (very much better) assessed immediately on completion of treatment. Secondary outcomes including EuroQol health related quality of life, EuroQol health status valuation, HAQ, 10 metre walk time and pain scores were collected at baseline, after treatment and 3 months later. Binary outcomes were analysed by Fisher's exact test and continuous variables by Wilcoxon or Mann-Whitney tests. Baseline characteristics of the two groups were comparable. Significantly more patients treated with hydrotherapy (40/46, 87%) were much better or very much better than the patients treated with land exercise (19/40, 47.5%), p < 0.001 Fisher's exact test. Eleven patients allocated land exercise failed to complete treatment compared with 4 patients allocated hydrotherapy (p = 0.09). Sensitivity analyses confirmed an advantage for hydrotherapy if we assumed non-completers would all not have responded (response rates 70% versus 38%; p < 0.001) or if we assumed that non-completers would have had the same response as completers (response rates 82% versus 55% p = 0.002). Ten metre walk time improved after treatment in both cases (median pre-treatment time for both groups combined 10.9 seconds, post-treatment 9.1 s, and 3 months later 9.6 s). There was however no difference between treatment groups. Similarly there were no significant differences between groups in terms of changes to HAQ, EQ-5D utility score, EQ VAS and pain VAS. Patients with RA treated with hydrotherapy are more likely to report feeling much better or very much better than those treated with land exercises immediately on completion of the treatment programme. This perceived benefit was not reflected by differences between groups in 10-metre walk times, functional scores, quality of life measures and pain scores.

Statistical Application and Cost Saving in a Dental Survey.

PubMed

Chyou, Po-Huang; Schroeder, Dixie; Schwei, Kelsey; Acharya, Amit

2017-06-01

To effectively achieve a robust survey response rate in a timely manner, an alternative approach to survey distribution, informed by statistical modeling, was applied to efficiently and cost-effectively achieve the targeted rate of return. A prospective environmental scan surveying adoption of health information technology utilization within their practices was undertaken in a national pool of dental professionals (N=8000) using an alternative method of sampling. The piloted approach to rate of cohort sampling targeted a response rate of 400 completed surveys from among randomly targeted eligible providers who were contacted using replicated subsampling leveraging mailed surveys. Two replicated subsample mailings (n=1000 surveys/mailings) were undertaken to project the true response rate and estimate the total number of surveys required to achieve the final target. Cost effectiveness and non-response bias analyses were performed. The final mailing required approximately 24% fewer mailings compared to targeting of the entire cohort, with a final survey capture exceeding the expected target. An estimated $5000 in cost savings was projected by applying the alternative approach. Non-response analyses found no evidence of bias relative to demographics, practice demographics, or topically-related survey questions. The outcome of this pilot study suggests that this approach to survey studies will accomplish targeted enrollment in a cost effective manner. Future studies are needed to validate this approach in the context of other survey studies. © 2017 Marshfield Clinic.

Timing the Mode Switch in a Sequential Mixed-Mode Survey: An Experimental Evaluation of the Impact on Final Response Rates, Key Estimates, and Costs

PubMed Central

Wagner, James; Schroeder, Heather M.; Piskorowski, Andrew; Ursano, Robert J.; Stein, Murray B.; Heeringa, Steven G.; Colpe, Lisa J.

2017-01-01

Mixed-mode surveys need to determine a number of design parameters that may have a strong influence on costs and errors. In a sequential mixed-mode design with web followed by telephone, one of these decisions is when to switch modes. The web mode is relatively inexpensive but produces lower response rates. The telephone mode complements the web mode in that it is relatively expensive but produces higher response rates. Among the potential negative consequences, delaying the switch from web to telephone may lead to lower response rates if the effectiveness of the prenotification contact materials is reduced by longer time lags, or if the additional e-mail reminders to complete the web survey annoy the sampled person. On the positive side, delaying the switch may decrease the costs of the survey. We evaluate these costs and errors by experimentally testing four different timings (1, 2, 3, or 4 weeks) for the mode switch in a web–telephone survey. This experiment was conducted on the fourth wave of a longitudinal study of the mental health of soldiers in the U.S. Army. We find that the different timings of the switch in the range of 1–4 weeks do not produce differences in final response rates or key estimates but longer delays before switching do lead to lower costs. PMID:28943717

Statistical Application and Cost Saving in a Dental Survey

PubMed Central

Chyou, Po-Huang; Schroeder, Dixie; Schwei, Kelsey; Acharya, Amit

2017-01-01

Objective To effectively achieve a robust survey response rate in a timely manner, an alternative approach to survey distribution, informed by statistical modeling, was applied to efficiently and cost-effectively achieve the targeted rate of return. Design A prospective environmental scan surveying adoption of health information technology utilization within their practices was undertaken in a national pool of dental professionals (N=8000) using an alternative method of sampling. The piloted approach to rate of cohort sampling targeted a response rate of 400 completed surveys from among randomly targeted eligible providers who were contacted using replicated subsampling leveraging mailed surveys. Methods Two replicated subsample mailings (n=1000 surveys/mailings) were undertaken to project the true response rate and estimate the total number of surveys required to achieve the final target. Cost effectiveness and non-response bias analyses were performed. Results The final mailing required approximately 24% fewer mailings compared to targeting of the entire cohort, with a final survey capture exceeding the expected target. An estimated $5000 in cost savings was projected by applying the alternative approach. Non-response analyses found no evidence of bias relative to demographics, practice demographics, or topically-related survey questions. Conclusion The outcome of this pilot study suggests that this approach to survey studies will accomplish targeted enrollment in a cost effective manner. Future studies are needed to validate this approach in the context of other survey studies. PMID:28373286

Comparison of Online Survey Recruitment Platforms for Hard-to-Reach Pregnant Smoking Populations: Feasibility Study

PubMed Central

Agas, Jessica Marie; Lee, Melissa; Pan, Julia Lily; Buttenheim, Alison Meredith

2018-01-01

Background Recruiting hard-to-reach populations for health research is challenging. Web-based platforms offer one way to recruit specific samples for research purposes, but little is known about the feasibility of online recruitment and the representativeness and comparability of samples recruited through different Web-based platforms. Objective The objectives of this study were to determine the feasibility of recruiting a hard-to-reach population (pregnant smokers) using 4 different Web-based platforms and to compare participants recruited through each platform. Methods A screener and survey were distributed online through Qualtrics Panel, Soapbox Sample, Reddit, and Amazon Mechanical Turk (mTurk). Descriptive statistics were used to summarize results of each recruitment platform, including eligibility yield, quality yield, income, race, age, and gestational age. Results Of the 3847 participants screened for eligibility across all 4 Web-based platforms, 535 were eligible and 308 completed the survey. Amazon mTurk yielded the fewest completed responses (n=9), 100% (9/9) of which passed several quality metrics verifying pregnancy and smoking status. Qualtrics Panel yielded 14 completed responses, 86% (12/14) of which passed the quality screening. Soapbox Sample produced 107 completed surveys, 67% (72/107) of which were found to be quality responses. Advertising through Reddit produced the highest completion rate (n=178), but only 29.2% (52/178) of those surveys passed the quality metrics. We found significant differences in eligibility yield, quality yield, age, number of previous pregnancies, age of smoking initiation, current smokers, race, education, and income (P<.001). Conclusions Although each platform successfully recruited pregnant smokers, results varied in quality, cost, and percentage of complete responses. Moving forward, investigators should pay careful attention to the percentage yield and cost of online recruitment platforms to maximize internal and external validity. PMID:29661751

New Topical Treatment Options for Actinic Keratosis: A Systematic Review.

PubMed

Stockfleth, Eggert; Sibbring, Gillian C; Alarcon, Ivette

2016-01-01

This systematic review compared the relative efficacy of 5-fluorouracil 0.5% in salicylic acid 10% (5-FU/SA), ingenol mebutate (IMB) and imiquimod 2.5%/3.75% (IMI) for actinic keratosis on the face, forehead or scalp. Only 11 publications, relating to 7 randomised controlled trials, met inclusion criteria and it was only possible to compare the effect of all 3 treatments on complete clinical clearance, and the effect of 5-FU/SA and IMB on actinic keratosis recurrence rate. Despite a higher vehicle response rate for 5-FU/SA, complete clinical clearance was higher than IMB and IMI (55.4, 42.2, and 25.0-30.6/34.0-35.6%, [corrected] respectively). 5-FU/SA was also associated with lower actinic keratosis recurrence rate than IMB at 12 months post-treatment (32.7 vs. 53.9%). Although qualitative assessment suggested a numerical advantage of 5-FU/SA over IMB and IMI in terms of complete clinical clearance and sustained clearance, clinical data from longer term trials, with comparable outcome measures, are required to corroborate these findings.

The significance of major and stable molecular responses in chronic myeloid leukemia in the tyrosine kinase inhibitor era

PubMed Central

Renault, Ilana Zalcberg; Scholl, Vanesa; Hassan, Rocio; Capelleti, Paola; de Lima, Marcos; Cortes, Jorge

2011-01-01

Tyrosine kinase inhibitors have changed the management and outcomes of chronic myeloid leukemia patients. Quantitative polymerase chain reaction is used to monitor molecular responses to tyrosine kinase inhibitors. Molecular monitoring represents the most sensitive tool to judge chronic myeloid leukemia disease course and allows early detection of relapse. Evidence of achieving molecular response is important for several reasons: 1. early molecular response is associated with major molecular response rates at 18-24 months; 2. patients achieving major molecular response are less likely to lose their complete cytogenetic response; 3. a durable, stable major molecular response is associated with increased progression-free survival. However, standardization of molecular techniques is still challenging. PMID:23049363

Information needs for the rapid response team electronic clinical tool.

PubMed

Barwise, Amelia; Caples, Sean; Jensen, Jeffrey; Pickering, Brian; Herasevich, Vitaly

2017-10-02

Information overload in healthcare is dangerous. It can lead to critical errors and delays. During Rapid Response Team (RRT) activations providers must make decisions quickly to rescue patients from physiological deterioration. In order to understand the clinical data required and how best to present that information in electronic systems we aimed to better assess the data needs of providers on the RRT when they respond to an event. A web based survey to evaluate clinical data requirements was created and distributed to all RRT providers at our institution. Participants were asked to rate the importance of each data item in guiding clinical decisions during a RRT event response. There were 96 surveys completed (24.5% response rate) with fairly even distribution throughout all clinical roles on the RRT. Physiological data including heart rate, respiratory rate, and blood pressure were ranked by more than 80% of responders as being critical information. Resuscitation status was also considered critically useful by more than 85% of providers. There is a limited dataset that is considered important during an RRT. The data is widely available in EMR. The findings from this study could be used to improve user-centered EMR interfaces.

The role of hydroxychloroquine in the treatment of lichen planopilaris: A retrospective case series and review.

PubMed

Nic Dhonncha, E; Foley, C C; Markham, T

2017-05-01

A variety of systemic agents are used to treat lichen planopilaris (LPP) with a limited evidence base. The aim of our study was to retrospectively review the response rate to and tolerability of hydroxychloroquine in a cohort of patients with LPP in an effort to add to the evidence base for its use. Twenty-three patients with a clinical and histopathological diagnosis of LPP who had been treated with hydroxychloroquine for their disease in a single center were identified. A retrospective review of these patients' medical records was performed and physician rated response was documented. Complete response was observed in 61% of our patients, and a further 9% of patients demonstrated partial response. Thirteen percent of patients withdrew from treatment because of suspected adverse effects. Our sample size was small, and data was collected retrospectively. We found hydroxychloroquine to be a reasonable therapeutic choice in LPP. © 2016 Wiley Periodicals, Inc.

Intrapericardial denervation - Radial artery blood flow and heart rate responses to LBNP

NASA Technical Reports Server (NTRS)

Mckeever, Kenneth H.; Skidmore, Michael G.; Keil, Lanny C.; Sandler, Harold

1990-01-01

The effects of intrapericardial denervation on the radial artery blood flow velocity (RABFV) and heart rate (HR) responses to LBNP in rhesus monkeys were investigated by measuring the RABFV transcutaneously by a continuous-wave Doppler ultrasonic flowmeter in order to derive an index of forearm blood flow response to low (0 to -20 mm Hg) and high (0 to -60 mm Hg) ramp exposures during supine LBNP. Four of the eight subjects were subjected to efferent and afferent cardiac denervation. It was found that, during low levels of LBNP, monkeys with cardiac denervation exhibited no cardiopulmonary baroreceptor-mediated change in the RABFV or HR, unlike the intact animals, which showed steady decreases in RABFV during both high- and low-pressure protocols. It is suggested that forearm blood flow and HR responses to low-level LBNP, along with pharmacological challenge, are viable physiological tests for verifying the completeness of atrial and cardiopulmonary baroreceptor denervation.

Host Transcriptional Response to Ebola Virus Infection

PubMed Central

Speranza, Emily; Connor, John H

2017-01-01

Ebola virus disease (EVD) is a serious illness that causes severe disease in humans and non-human primates (NHPs) and has mortality rates up to 90%. EVD is caused by the Ebolavirus and currently there are no licensed therapeutics or vaccines to treat EVD. Due to its high mortality rates and potential as a bioterrorist weapon, a better understanding of the disease is of high priority. Multiparametric analysis techniques allow for a more complete understanding of a disease and the host response. Analysis of RNA species present in a sample can lead to a greater understanding of activation or suppression of different states of the immune response. Transcriptomic analyses such as microarrays and RNA-Sequencing (RNA-Seq) have been important tools to better understand the global gene expression response to EVD. In this review, we outline the current knowledge gained by transcriptomic analysis of EVD. PMID:28930167

Self-esteem levels and cardiovascular and inflammatory responses to acute stress.

PubMed

O'Donnell, Katie; Brydon, Lena; Wright, Caroline E; Steptoe, Andrew

2008-11-01

Acute mental stress tests have helped to clarify the pathways through which psychosocial factors are linked to disease risk. This methodology is now being used to investigate potentially protective psychosocial factors. We investigated whether global self-esteem might buffer cardiovascular and inflammatory responses to acute stress. One hundred and one students completed the Rosenberg Self-Esteem Scale. Heart rate and heart rate variability (HRV) were recorded for 5 min periods at baseline, during two mental stress tasks, (a speech and a color-word task) and 10, 25 and 40 min into a recovery period. Plasma levels of tumor-necrosis factor-alpha (TNF-alpha), interleukin-6 (IL-6) and interleukin-1 receptor antagonist (IL-1Ra) were assessed at baseline, immediately post-stress and after 45 min recovery. Repeated measures analysis of variance demonstrated that heart rate levels were lower across all time points in those with high self-esteem, although heart rate reactivity to stress was not related to self-esteem. There were no differences in baseline HRV, TNF-alpha, IL-6 or IL-1Ra. Multiple linear regressions revealed that greater self-esteem was associated with a smaller reduction in heart rate variability during the speech task, but not the color-word task. Greater self-esteem was associated with smaller TNF-alpha and IL-1Ra responses immediately following acute stress and smaller IL-1Ra responses at 45 min post-stress. In conclusion, global self-esteem is associated with lower heart rate and attenuated HRV and inflammatory responses to acute stress. These responses could be processes through which self-esteem protects against the development of disease.

Measures of Affect and Nicotine Dependence Predict Differential Response to Smoking Cessation Treatments.

ERIC Educational Resources Information Center

Zelman, Diane C.; And Others

1992-01-01

Randomly assigned smokers (n=126) to six-session smoking cessation treatments consisting of skills training or support counseling strategies and nicotine gum or rapid smoking nicotine exposure strategies. Counseling and nicotine strategies were completely crossed; all four combinations resulted in equivalent one-year abstinence rates. Treatments…

Learned Helplessness in the Classroom: Some Good News and Some Bad.

ERIC Educational Resources Information Center

Dickens, Wenda J.; Perry, Raymond P.

The effects of amount of exposure to response/outcome independence and teacher expressiveness on student ratings of the instructor, achievement test performance, and attribution items were studied. University students completed an aptitude test that provided contingent or noncontingent feedback and varied in length (short, medium, or long). All…

Expectancy Theory Outcomes and Student Evaluations of Teaching

ERIC Educational Resources Information Center

Ernst, David

2014-01-01

As student evaluation of teaching (SET) instruments are increasingly administered online, research has found that the response rates have dropped significantly. Validity concerns have necessitated research that explores student motivation for completing SETs. This study uses Vroom's [(1964). "Work and motivation" (3rd ed.). New York, NY:…

Building Confidence in Agricultural Leaders

ERIC Educational Resources Information Center

Patten, Justin C.; Moore, Lori L.

2006-01-01

This study sought to examine differences in the confidence level of Leadership Idaho Agriculture (LIA) graduates within six program areas in terms of their perceptions before and after participation in LIA. Of the 348 individuals included in the population frame, 246 individuals completed a then-post survey instrument for a total response rate of…

A Demonstration of Validity for Certification by the American Board of Anesthesiology.

ERIC Educational Resources Information Center

Slogoff, Stephen; And Others

1994-01-01

To investigate the validity of anesthesiologist certification, 146 anesthesiology program directors were asked whether they would permit each of their graduating residents to complete 3 increasingly complex anesthetic regimens to the directors themselves and rate residents on specific skills. Director responses generally correspond to…

Increased cardiac output and maximal oxygen uptake in response to ten sessions of high intensity interval training.

PubMed

Astorino, Todd A; Edmunds, Ross M; Clark, Amy; King, Leesa; Gallant, Rachael M; Namm, Samantha; Fischer, Anthony; Wood, Kimi A

2018-01-01

Increases in maximal oxygen uptake (VO2max) are widely reported in response to completion of high intensity interval training (HIIT), yet the mechanism explaining this result is poorly understood. This study examined changes in VO2max and cardiac output (CO) in response to 10 sessions of low-volume HIIT. Participants included 30 active men and women (mean age and VO2max=22.9±5.4 years and 39.6±5.6 mL/kg/min) who performed HIIT and 30 men and women (age and VO2max=25.7±4.5 years and 40.7±5.2 mL/kg/min) who served as non-exercising controls (CON). High intensity interval training consisted of 6-10 s bouts of cycling per session at 90-110 percent peak power output (PPO) interspersed with 75 s recovery. Before and after training, progressive cycling to exhaustion was completed during which CO, stroke volume (SV), and heart rate (HR) were estimated using thoracic impedance. To confirm VO2max attainment, a verification test was completed after progressive cycling at a work rate equal to 110%PPO. Data demonstrated significant improvements in VO2max (2.71±0.63 L/min to 2.86±0.63 L/min, P<0.001) and COmax (20.0±3.1 L/min to 21.7±3.2 L/min, P=0.04) via HIIT that were not exhibited in CON. Maximal SV was increased in HIIT (P=0.04) although there was no change in maximal HR (P=0.57). The increase in VO2max seen in response to ten sessions of HIIT is due to improvements in oxygen delivery.

Early results of multicenter phase II trial of perioperative oxaliplatin and capecitabine without radiotherapy for high-risk rectal cancer: CORONA I study.

PubMed

Kamiya, T; Uehara, K; Nakayama, G; Ishigure, K; Kobayashi, S; Hiramatsu, K; Nakayama, H; Yamashita, K; Sakamoto, E; Tojima, Y; Kawai, S; Kodera, Y; Nagino, M

2016-06-01

Perioperative introduction of developed chemotherapy into the treatment strategy for locally advanced rectal cancer (LARC) may be a promising option. However, the most prevalent treatment for high-risk LARC remains preoperative chemoradiotherapy (CRT) in Western countries. A phase II trial was undertaken to evaluate safety and efficacy of perioperative XELOX without radiotherapy (RT) for patients with high-risk LARC. Patients received 4 cycles of XELOX before and after surgery, respectively. Primary endpoint was disease-free survival. We enrolled 41 patients between June 2012 and April 2014. The completion rate of the preoperative XELOX was 90.3%. Twenty-nine patients (70.7%) could start postoperative XELOX, 15 of these patients (51.7%) completed 4 cycles. Allergic reaction to oxaliplatin was experienced by 5 patients (17.2%) during postoperative XELOX. One patient received additional RT after preoperative XELOX. Consequently, the remaining 40 patients underwent primary resection. Major complications occurred in 6 of 40 patients (15.0%). Pathological complete response (pCR) rate was 12.2%, and good tumor regression was exhibited in 31.7%. N down-staging (cN+ to ypN0) and T down-staging were detected in 56.7% and 52.5%, respectively. Clinical T4 tumor was a predictor of poor pathological response (p < 0.001). We could show the favorable pCR rate after preoperative XELOX alone. However, the T and N down-staging rate was likely to be insufficient. When tumor regression is essential for curative resection, the use of preoperative CRT is likely to be recommended. For patients with massive LN metastasis, the additional Bev to NAC might be a promising option. Copyright © 2016 Elsevier Ltd. All rights reserved.

EMP combination chemotherapy and low-dose monotherapy in advanced prostate cancer.

PubMed

Kitamura, Tadaichi; Nishimatsu, Hiroaki; Hamamoto, Toshiaki; Tomita, Kyoichi; Takeuchi, Takumi; Ohta, Nobutaka

2002-02-01

Many chemotherapeutic regimens combined with estramustine phosphate (EMP) have been elaborated for the treatment of hormone-refractory prostate cancer over 30 years. However, older EMP-based combination chemotherapies with vinblastine, vinorelbine, doxorubicin or cyclophosphamide showed relatively low PSA response rate (25-58%) accompanied with high toxicities. On the other hand, newly developed EMP-based combination regimens with etoposide, pacitaxel, carboplatin or docetaxel demonstrated promising PSA response rate (43-77%) with moderate to severe toxicity in the rate of thromboembolic event (5-18%) and of neutropenia (9-41%). Treatment-related death was less in the latter combination group (5/615, 0.8%) than that in the former group (3/234, 1.3%). Of note, in the docetaxel combination with EMP, PSA response rate is as high as 77% with high rate (41%) of neutropenia but no treatment-related death was observed. Docetaxel combination with EMP seems to be the best regimen, though not completely justified by randomized trials, to be selected in the modern era, which will be followed by paclitaxel, carboplatin and EMP combination with PSA response rate of 71%. In addition, an interim report in 83 patients was presented. They were not consecutively enrolled but were treated on low-dose EMP monotherapy for previously untreated advanced prostate cancer in Department of Urology of Tokyo University and our 21 affiliated hospitals. Overall PSA response rate was as high as 93.4% out of 76 assessable patients. However, overall toxicity rate was abnormally high (39.5%) with drug discontinuation rate of 32.1%. The reason of low drug compliance may be attributed to gastrointestinal symptoms. To overcome the low drug compliance, appropriate patients for EMP administration should be selected by using gene analysis on the basis of sophisticated tailor-made medicine.

Novel therapy in multiple myeloma.

PubMed

Avilés, Agustin; Neri, Natividad; Nambo, M Jesús; Cleto, Sergio; Castañeda, Claudia; González, Martha; Talavera, Alejandra; Huerta-Guzmán, Judith

2005-10-01

Treatment in patients with multiple myeloma remain to be defined. Younger patients (defined as a cut-off level < 65 years old) will be treated with chemotherapy and transplant procedures. However, most patients > 65 years old are not candidates for this therapeutic approach and the use of intensive chemotherapy could be associated to severe toxicity. We developed an new, not-cytotoxic regimen with dexamethasone 30 mg/m(2), iv, days 1 to 4, all trans retinoic acid 45 mg/m(2), po, days 5 to 14 and interferon alfa 2a 4.5 MU, sc, daily, days 5 to 14 (DAI regimen) administered every 28 days in number of 6 cycles, at this point patients were restaging, if they showed complete response, objective response or partial response they were conducted to received thalidomide 100-200 mg po, daily and dexamethasone 10 mg/2, po days 1 to 4 at monthly intervals, for 18 months. Forty one patients were enrolled in an Phase II study. In an intent to treat analysis all patients were evaluable. Complete response was observed in 18 cases (43%), objective response in 10 patients (24%) and partial response in 5 patients (12%), overall response rate was 80%. Eight patients were considered failures. At an median of 36 months, no relapse of progression disease has been observed, thus actuarial curves at 3-years showed that event free survival is 100% and overall survival is 91%. Toxicity was mild, all patients received the planned dose in time. This regimen appear to be useful in older patients with multiple myeloma, the response rate is higher and toxicity was mild. Controlled clinical trials comparing with conventional chemotherapy will be conducted to define the role of this therapeutic approach.

A Pilot Study of Women’s Affective Responses to Common and Uncommon Forms of Aerobic Exercise

PubMed Central

Stevens, Courtney J.; Smith, Jane Ellen; Bryan, Angela D.

2015-01-01

Objective To test the extent to which participants exposed to an uncommon versus common exercise stimulus would result in more favourable affect at post task. Design Experimental design. Participants, (N = 120) American women aged 18–45 years, were randomly assigned to complete 30-minutes of either the uncommon (HOOP; n = 58) or common (WALK; n = 62) exercise stimulus. Main Outcome Measures Self-reported affect and intentions for future exercise were measured before and after the 30-minute exercise bout. Results Analyses of covariance (ANCOVA) were run to compare post-task affect across the HOOP and WALK conditions. At post-task, participants assigned to HOOP reported more positively valenced affect, higher ratings of positive activated affect, lower ratings of negative deactivated affect, and stronger intentions for future aerobic exercise compared to participants assigned to WALK. Conclusions Participants who completed an uncommon bout of aerobic exercise (HOOP) reported more favourable affect post-exercise, as well as stronger intentions for future exercise, compared to participants who completed a common bout of aerobic exercise (WALK). Future work using a longitudinal design is needed to understand the relationships between familiarity with an exercise stimulus, affective responses to exercise, motivation for future exercise behaviour, and exercise maintenance over time. PMID:26394246

Response time scores on a reflexive attention task predict a child's inattention score from a parent report.

PubMed

Lundwall, Rebecca A; Sgro, Jordan F; Fanger, Julia

2018-01-01

Compared to sustained attention, only a small proportion of studies examine reflexive attention as a component of everyday attention. Understanding the significance of reflexive attention to everyday attention may inform better treatments for attentional disorders. Children from a general population (recruited when they were from 9-16 years old) completed an exogenously-cued task measuring the extent to which attention is captured by peripheral cue-target conditions. Parents completed a questionnaire reporting their child's day-to-day attention. A general linear model indicated that parent-rated inattention predicted the increase in response time over baseline when a bright cue preceded the target (whether it was valid or invalid) but not when a dim cue preceded the target. More attentive children had more pronounced response time increases from baseline. Our findings suggest a link between a basic measure of cognition (response time difference scores) and parent observations. The findings have implications for increased understanding of the role of reflexive attention in the everyday attention of children.

An open treatment trial of venlafaxine for elderly patients with dysthymic disorder.

PubMed

Devanand, D P; Juszczak, Nicole; Nobler, Mitchell S; Turret, Nancy; Fitzsimons, Linda; Sackeim, Harold A; Roose, Steven P

2004-12-01

Treatment response and side effects of venlafaxine were evaluated in an open-label trial of elderly outpatients with dysthymic disorder (DD). Patients received flexible dose (up to 300 mg/d) venlafaxine (Effexor XR) for 12 weeks. Of 23 study patients, 18 completed the trial. Fourteen (60.9%) were responders in intent-to-treat analyses with the last observation carried forward, and 77.8% were responders in completer analyses. Nearly half the sample (47.8%) met criteria for remission. In the intent-to-treat sample, increased severity of depression at baseline was associated with superior response, and the presence of cardiovascular disease was associated with poorer response. Venlafaxine open-label treatment was associated with fairly high response rates and generally good tolerability in elderly patients with DD. These results indicate that in elderly patients with DD, placebo-controlled trials of a dual reuptake inhibitor such as venlafaxine would be needed to assess its efficacy or to compare its efficacy to that of other antidepressants.

Interactive versus passive distraction for acute pain management in young children: the role of selective attention and development.

PubMed

Wohlheiter, Karen A; Dahlquist, Lynnda M

2013-03-01

To examine whether age and developmental differences in selective attention influence young children's differential responses to interactive and passive distraction. 65 3- to 6-year-old children underwent three cold-pressor trials while receiving no intervention, playing a video game (interactive distraction), or watching a video game (passive distraction). In addition, children completed a test of selective attention, and parents completed ratings of attention. Consistent with neurocognitive models of pain, children benefited more from interactive distraction than from passive distraction. Although older children demonstrated superior pain tolerance overall, age and selective attention skills did not moderate children's responses to the distraction intervention. These findings suggest that younger preschoolers can benefit from interactive distraction to manage acute pain, provided that the distraction activity is developmentally appropriate. Research is needed to determine whether developmental issues are more important moderators of children's responses to distraction when faced with more challenging task demands.

Postirradiation squamous cell carcinoma in situ of the vagina: treatment by topical 20 percent 5-fluorouracil cream

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

Piver, M.S.; Barlow, J.J.; Tsukada, Y.

1979-10-01

Eight patients with squamous cell carcinoma in situ of the vagina were treated with monthly 5 day courses of 20% 5-fluorouracil cream applied to the vagina. Seven (87.5%) of the women had an initial complete response; however, three subsequently developed recurrence after the treatment was stopped. They were retreated, and two of these three patients achieved a subsequent complete response. The overall response to therapy was 75% (6/8) with the six women off therapy from 1.1 to 6.9 years. Total follow-up of all patients was 3.1 to 6.9 years with no patients having developed invasive carcinoma. Because of the highmore » success rate with no associated serious sequelae, this is believed to be a satisfactory method of therapy for women with squamous cell carcinoma in situ of the vagina occurring after pelvic irradiation.« less

Design and operation of the national home health aide survey: 2007-2008.

PubMed

Bercovitz, Anita; Moss, Abigail J; Sengupta, Manisha; Harris-Kojetin, Lauren D; Squillace, Marie R; Emily, Rosenoff; Branden, Laura

2010-03-01

This report provides an overview of the National Home Health Aide Survey (NHHAS), the first national probability survey of home health aides. NHHAS was designed to provide national estimates of home health aides who provided assistance in activities of daily living (ADLs) and were directly employed by agencies that provide home health and/or hospice care. This report discusses the need for and objectives of the survey, the design process, the survey methods, and data availability. METHODS NHHAS, a multistage probability sample survey, was conducted as a supplement to the 2007 National Home and Hospice Care Survey (NHHCS). Agencies providing home health and/or hospice care were sampled, and then aides employed by these agencies were sampled and interviewed by telephone. Survey topics included recruitment, training, job history, family life, client relations, work-related injuries, and demographics. NHHAS was virtually identical to the 2004 National Nursing Assistant Survey of certified nursing assistants employed in sampled nursing homes with minor changes to account for differences in workplace environment and responsibilities. RESULTS From September 2007 to April 2008, interviews were completed with 3,416 aides. A public-use data file that contains the interview responses, sampling weights, and design variables is available. The NHHAS overall response rate weighted by the inverse of the probability of selection was 41 percent. This rate is the product of the weighted first-stage agency response rate of 57 percent (i.e., weighted response rate of 59 percent for agency participation in NHHCS times the weighted response rate of 97 percent for agencies participating in NHHCS that also participated in NHHAS) and the weighted second-stage aide response rate of 72 percent to NHHAS.

Reliability, construct validity, and responsiveness of the neck disability index, patient-specific functional scale, and numeric pain rating scale in patients with cervical radiculopathy.

PubMed

Young, Ian A; Cleland, Joshua A; Michener, Lori A; Brown, Chris

2010-10-01

To examine the psychometric properties of the Neck Disability Index, Patient-Specific Functional Scale, and the Numeric Pain Rating Scale in a cohort of patients with cervical radiculopathy. A single-group repeated-measures design. Patients (n = 165) presenting to physical therapy with cervical radiculopathy completed the Neck Disability Index, Patient-Specific Functional Scale, and Numeric Pain Rating Scale at the baseline examination and at a follow-up. At the time of follow-up, all patients also completed the Global Rating of Change, which was used to dichotomize patients as improved or stable. Baseline and follow-up scores were used to determine the test-retest reliability, construct validity, and minimal levels of detectable and clinically important change for the Neck Disability Index, Patient-Specific Functional Scale, and Numeric Pain Rating Scale. Both the Neck Disability Index and Numeric Pain Rating Scale exhibited fair test-retest reliability, whereas the Patient-Specific Functional Scale exhibited poor reliability in patients with cervical radiculopathy. All three outcome measures showed adequate responsiveness in this patient population. The minimal detectable change was 13.4 for the Neck Disability Index, 3.3 for the Patient-Specific Functional Scale, and 4.1 for the Numeric Pain Rating Scale. The threshold for the minimal clinically important difference was 8.5 for the Neck Disability Index and 2.2 for both the Patient-Specific Functional Scale and Numeric Pain Rating Scale. In light of the varied distribution of symptoms in patients with cervical radiculopathy, future studies should investigate the psychometric properties of other neck-related disability measures in this patient population.

Accelerated superfractionated radiotherapy for inflammatory breast carcinoma: complete response predicts outcome and allows for breast conservation.

PubMed

Arthur, D W; Schmidt-Ullrich, R K; Friedman, R B; Wazer, D E; Kachnic, L A; Amir, C; Bear, H D; Hackney, M H; Smith, T J; Lawrence, W

1999-05-01

Chemotherapy and accelerated superfractionated radiotherapy were prospectively applied for inflammatory breast carcinoma with the intent of breast conservation. The efficacy, failure patterns, and patient tolerance utilizing this approach were analyzed. Between 1983 and 1996, 52 patients with inflammatory breast carcinoma presented to the Medical College of Virginia Hospitals of VCU and the New England Medical Center. Thirty-eight of these patients were jointly evaluated in multidisciplinary breast clinics and managed according to a defined prospectively applied treatment policy. Patients received induction chemotherapy, accelerated superfractionated radiotherapy, selected use of mastectomy, and concluded with additional chemotherapy. The majority were treated with 1.5 Gy twice daily to field arrangements covering the entire breast and regional lymphatics. An additional 18-21 Gy was then delivered to the breast and clinically involved nodal regions. Total dose to clinically involved areas was 63-66 Gy. Following chemoradiotherapy, patients were evaluated with physical examination, mammogram, and fine needle aspiration x 3. Mastectomy was reserved for those patients with evidence of persistent or progressive disease in the involved breast. All patients received additional chemotherapy. Median age was 51 years. Median follow-up was 23.9 months (6-86) months. The breast preservation rate at the time of last follow-up was 74%. The treated breast or chest wall as the first site of failure occurred in only 13%, and the ultimate local control rate with the selected use of mastectomy was 74%. Ten patients underwent mastectomy, 2 of which had pathologically negative specimens despite a clinically palpable residual mass. Response to chemotherapy was predictive of treatment outcome. Of the 15 patients achieving a complete response, 87% remain locoregionally controlled without the use of mastectomy. Five-year overall survival for complete responders was 68%. This is in contrast to the 14% 5-year overall survival observed with incomplete responders. The 5-year actuarial disease-free survival and overall survival for the entire patient cohort was 11% and 33%, respectively. All patients tolerated irradiation with limited acute effects, of which all were managed conservatively. Our experience demonstrates that induction chemotherapy, accelerated superfractionated radiotherapy, and the selected use of mastectomy results in excellent locoregional control rates, is well tolerated, and optimizes breast preservation. Based on our present results, we recommend that a patient's response to induction chemotherapy guide the treatment approach used for locoregional disease, such that mastectomy be reserved for incomplete responders and avoided in those achieving a complete response.

Concerns among first year midwifery students: towards addressing attrition rates.

PubMed

Carolan, Mary C; Kruger, Gina B

2011-01-01

Since 2000, there has been a shift to undergraduate midwifery education in Australia. Midwifery students are generally highly motivated, however attrition rates remain high among first-year students. This study was undertaken in one Australian University against a background of high course demand and high student attrition. Thirty-two first-year midwifery students completed a demographic questionnaire and wrote a reflection in response to the question: What if anything, would make your experience as a first year student better? Data were subjected to thematic content analysis. Findings indicated a need for: greater opportunities to prepare; for more time to study; for greater student supports; and outlined difficulties such as financial and childcare. In conclusion, undergraduate midwifery courses and local conditions vary among institutions. Student feedback is a useful way of identifying local concerns that may impact on student completion rates. This is a necessary first step to the provision of meaningful student support.

Avelumab, an Anti–Programmed Death-Ligand 1 Antibody, In Patients With Refractory Metastatic Urothelial Carcinoma: Results From a Multicenter, Phase Ib Study

PubMed Central

Apolo, Andrea B.; Infante, Jeffrey R.; Balmanoukian, Ani; Patel, Manish R.; Wang, Ding; Kelly, Karen; Mega, Anthony E.; Britten, Carolyn D.; Ravaud, Alain; Mita, Alain C.; Safran, Howard; Stinchcombe, Thomas E.; Srdanov, Marko; Gelb, Arnold B.; Schlichting, Michael; Chin, Kevin; Gulley, James L.

2017-01-01

Purpose We assessed the safety and antitumor activity of avelumab, a fully human anti–programmed death-ligand 1 (PD-L1) IgG1 antibody, in patients with refractory metastatic urothelial carcinoma. Methods In this phase Ib, multicenter, expansion cohort, patients with urothelial carcinoma progressing after platinum-based chemotherapy and unselected for PD-L1 expression received avelumab 10 mg/kg intravenously every 2 weeks. The primary objectives were safety and tolerability. Secondary objectives included confirmed objective response rate (Response Evaluation Criteria in Solid Tumors [RECIST] version 1.1), progression-free survival, overall survival (OS), and PD-L1–associated clinical activity. PD-L1 positivity was defined as expression by immunohistochemistry on ≥ 5% of tumor cells. Results Forty-four patients were treated with avelumab and followed for a median of 16.5 months (interquartile range, 15.8 to 16.7 months). The data cutoff was March 19, 2016. The most frequent treatment-related adverse events of any grade were fatigue/asthenia (31.8%), infusion-related reaction (20.5%), and nausea (11.4%). Grades 3 to 4 treatment-related adverse events occurred in three patients (6.8%) and included asthenia, AST elevation, creatine phosphokinase elevation, and decreased appetite. The confirmed objective response rate by independent central review was 18.2% (95% CI, 8.2% to 32.7%; five complete responses and three partial responses). The median duration of response was not reached (95% CI, 12.1 weeks to not estimable), and responses were ongoing in six patients (75.0%), including four of five complete responses. Seven of eight responding patients had PD-L1–positive tumors. The median progression-free survival was 11.6 weeks (95% CI, 6.1 to 17.4 weeks); the median OS was 13.7 months (95% CI, 8.5 months to not estimable), with a 12-month OS rate of 54.3% (95% CI, 37.9% to 68.1%). Conclusion Avelumab was well tolerated and associated with durable responses and prolonged survival in patients with refractory metastatic UC. PMID:28375787

Avelumab, an Anti-Programmed Death-Ligand 1 Antibody, In Patients With Refractory Metastatic Urothelial Carcinoma: Results From a Multicenter, Phase Ib Study.

PubMed

Apolo, Andrea B; Infante, Jeffrey R; Balmanoukian, Ani; Patel, Manish R; Wang, Ding; Kelly, Karen; Mega, Anthony E; Britten, Carolyn D; Ravaud, Alain; Mita, Alain C; Safran, Howard; Stinchcombe, Thomas E; Srdanov, Marko; Gelb, Arnold B; Schlichting, Michael; Chin, Kevin; Gulley, James L

2017-07-01

Purpose We assessed the safety and antitumor activity of avelumab, a fully human anti-programmed death-ligand 1 (PD-L1) IgG1 antibody, in patients with refractory metastatic urothelial carcinoma. Methods In this phase Ib, multicenter, expansion cohort, patients with urothelial carcinoma progressing after platinum-based chemotherapy and unselected for PD-L1 expression received avelumab 10 mg/kg intravenously every 2 weeks. The primary objectives were safety and tolerability. Secondary objectives included confirmed objective response rate (Response Evaluation Criteria in Solid Tumors [RECIST] version 1.1), progression-free survival, overall survival (OS), and PD-L1-associated clinical activity. PD-L1 positivity was defined as expression by immunohistochemistry on ≥ 5% of tumor cells. Results Forty-four patients were treated with avelumab and followed for a median of 16.5 months (interquartile range, 15.8 to 16.7 months). The data cutoff was March 19, 2016. The most frequent treatment-related adverse events of any grade were fatigue/asthenia (31.8%), infusion-related reaction (20.5%), and nausea (11.4%). Grades 3 to 4 treatment-related adverse events occurred in three patients (6.8%) and included asthenia, AST elevation, creatine phosphokinase elevation, and decreased appetite. The confirmed objective response rate by independent central review was 18.2% (95% CI, 8.2% to 32.7%; five complete responses and three partial responses). The median duration of response was not reached (95% CI, 12.1 weeks to not estimable), and responses were ongoing in six patients (75.0%), including four of five complete responses. Seven of eight responding patients had PD-L1-positive tumors. The median progression-free survival was 11.6 weeks (95% CI, 6.1 to 17.4 weeks); the median OS was 13.7 months (95% CI, 8.5 months to not estimable), with a 12-month OS rate of 54.3% (95% CI, 37.9% to 68.1%). Conclusion Avelumab was well tolerated and associated with durable responses and prolonged survival in patients with refractory metastatic UC.

Laboratory-Induced Stress and Craving among Individuals with Prescription Opioid Dependence

PubMed Central

Back, Sudie E.; Gros, Daniel F.; Price, Matthew; LaRowe, Steve; Flanagan, Julianne; Brady, Kathleen T.; Davis, Charles; Jaconis, Maryanne; McCauley, Jenna L.

2015-01-01

Background Stress and conditioned drug cues have been implicated in the initiation, maintenance and relapse to substances of abuse. Although stress and drug cues are often encountered together, little research exists on whether stress potentiates the response to drug cues. Method Participants (N = 75) were 39 community recruited individuals with current prescription opioid (PO) dependence and 36 healthy controls. Participants stayed overnight in the hospital for one night and then completed laboratory testing the following morning. During laboratory testing, participants were randomly assigned to a stress task (Trier Social Stress Task; TSST) or a no-stress condition. Following the stress manipulation, all participants completed a PO cue paradigm. Immediately before and after the stress and cue tasks, the following were assessed: subjective (stress, craving, anger, sadness, happiness), physiological (heart rate, blood pressure, galvanic skin response), and neuroendocrine responses (cortisol and dehydroepiandrosterone). Results Internal validity of the stress task was demonstrated, as evidenced by significantly higher subjective stress, as well as cortisol, heart rate and blood pressure in the TSST compared to the no-stress group. Individuals with PO dependence evidenced significantly greater reactivity to the stress task than controls. Craving increased significantly in response to the drug cue task among PO participants. No stress × cue interaction was observed. Conclusions In this study, heightened stress reactivity was observed among individuals with PO dependence. Exposure to acute stress, however, did not potentiate craving in response to conditioned drug cues. PMID:26342626

IIVP salvage regimen induces high response rates in patients with relapsed lymphoma before autologous stem cell transplantation.

PubMed

Abali, Huseyin; Oyan, Basak; Koc, Yener; Kars, Ayse; Barista, Ibrahim; Uner, Aysegul; Turker, Alev; Demirkazik, Figen; Tekin, Fatma; Tekuzman, Gulten; Kansu, Emin

2005-06-01

Patients with relapsed lymphoma can be cured with high-dose chemotherapy and autologous hematopoietic stem cell transplantation (HSCT). New therapeutic approaches with better cytoreductive capacity are needed for relapsed patients to keep their chance for cure with transplantation. We report 30 patients with relapsed lymphoma, median age 43 years, treated with IIVP salvage regimen consisting of ifosfamide, mesna, idarubicin, and etoposide for 2 or 3 cycles. Seventeen patients had non-Hodgkin lymphoma (NHL) and 13 patients had Hodgkin disease (HD). Fourteen (47%) patients were at their first relapse. Overall response rate was 86.6% (n = 26) with 19 patients (63.3%) achieving complete response. Overall response rate was 92% in patients with HD and 82% in NHL. The most frequent side effects observed were grade III-IV neutropenia (87%) and thrombocytopenia (73%). IIVP regimen is a highly effective salvage therapy for patients with relapsed HD or NHL who are candidates for autologous HSCT. Close follow up is necessary because of the high incidence of grade III-IV hematologic toxicity.

Quantifying the Physiological Stress Response to Simulated Maritime Pilotage Tasks: The Influence of Task Complexity and Pilot Experience.

PubMed

Main, Luana C; Wolkow, Alexander; Chambers, Timothy P

2017-11-01

The aim of this study was to quantify the stress associated with performing maritime pilotage tasks in a high-fidelity simulator. Eight trainee and 13 maritime pilots completed two simulated pilotage tasks of varying complexity. Salivary cortisol samples were collected pre- and post-simulation for both trials. Heart rate was measured continuously throughout the study. Significant changes in salivary cortisol (P = 0.000, η = 0.139), average (P = 0.006, η = 0.087), and peak heart rate (P = 0.013, η = 0.077) from pre- to postsimulation were found. Varying task complexity did partially influence stress response; average (P = 0.016, η = 0.026) and peak heart rate (P = 0.034, η = 0.020) were higher in the experimental condition. Trainees also recorded higher average (P = 0.000, η = 0.054) and peak heart rates (P = 0.027, η = 0.022). Performing simulated pilotage tasks evoked a measurable stress response in both trainee and expert maritime pilots.

Impact of participant incentives and direct and snowball sampling on survey response rate in an ethnically diverse community: results from a pilot study of physical activity and the built environment.

PubMed

Perez, Daniel F; Nie, Jason X; Ardern, Chris I; Radhu, Natasha; Ritvo, Paul

2013-02-01

Community-wide efforts to encourage healthy behaviours must respond to the needs of existing neighbourhoods, especially those where low physical activity (PA) is associated with social, economic, and cultural challenges. This study reports on the effect of direct and snowball sampling strategies and financial incentive levels on the response rates of a built environment and PA survey in a predominately urban, low-SES new-immigrant community. Women residing in the Jane-Finch neighbourhood of Toronto, Ontario were selected to participate by quasi-random sampling, yielding a response rate of 41.5%. The survey completion rate per contact attempt increased 2-fold when incentives were increased from $10 to $20 and a further threefold following the increase from $20 to $30. Snowball sampled respondents were older, less likely to have full-time employment, and had lower educational attainment than directly sampled participants. With appropriate incentives, face-to-face contact, and snowball sampling, survey-based research is feasible within a low-SES, high minority population.

Combat-Related Posttraumatic Headache: Diagnosis, Mechanisms of Injury, and Challenges to Treatment

DTIC Science & Technology

2010-09-01

514 • JAOA • Vol 110 • No 9 • September 2010 Kozminski • Original Contribution Context: Studies have revealed the rates of posttraumatic stress ...Although studies1-4 have reported rates of post- traumatic stress disorder (PTSD) and concussion or mild TBI for US soldiers returning from combat... stressful response that the details of the head injury also completed the required half day per week of continuity clinic. During this time frame, I

Multicenter analysis of treatment outcomes in adult patients with lymphoblastic lymphoma who received hyper-CVAD induction followed by hematopoietic stem cell transplantation.

PubMed

Jeong, Seong Hyun; Moon, Joon Ho; Kim, Jin Seok; Yang, Deok-Hwan; Park, Yong; Cho, Seok Goo; Kwak, Jae-Yong; Eom, Hyeon Seok; Won, Jong Ho; Hong, Jun Shik; Oh, Sung Yong; Lee, Ho Sup; Kim, Seok Jin

2015-04-01

The hyperfractionated cyclophosphamide, vincristine, doxorubicin, and dexamethasone (hyper-CVAD) regimen has been widely used for lymphoblastic lymphoma (LBL) as a primary treatment. However, there is few data about its treatment outcome in Asian patients. Thus, we conducted this study to evaluate the efficacy of hyper-CVAD induction and stem cell transplantation (SCT) consolidation in LBL patients. The treatment responses of 49 patients treated with the hyper-CVAD regimen were retrospectively analyzed in 13 institutions. Given 24 patients who responded to hyper-CVAD underwent consolidation treatment with SCT, overall survival (OS) and progression-free survival (PFS) of patients who received SCT were compared with patients who did not. The overall response rate was 79 %: 73 % (36/49) complete responses, 6 % (3/49) partial responses, and 4 % (2/49) induction deaths. The major limitation for the delivery of the planned hyper-CVAD cycles was hematological toxicity. Among 39 responders, 24 patients underwent autologous (n = 16) and allogeneic SCT (n = 8) consolidation. Their 3-year OS and PFS rates were 76 and 78 %, respectively, and there was no difference in survival outcomes between autologous and allogeneic SCT. However, 15 patients without SCT consolidation showed poorer PFS even though they all achieved complete response. Thus, only seven patients maintained their response at the time of analysis. In conclusion, the hyper-CVAD regimen is effective for remission induction in LBL, and SCT consolidation after hyper-CVAD induction produced better clinical outcomes than did continuation of hyper-CVAD.

Assessment of the Radiation-Equivalent of Chemotherapy Contributions in 1-Phase Radio-chemotherapy Treatment of Muscle-Invasive Bladder Cancer

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

Plataniotis, George A., E-mail: george.plataniotis@nhs.net; Dale, Roger G.

2014-03-15

Purpose: To estimate the radiation equivalent of the chemotherapy contribution to observed complete response rates in published results of 1-phase radio-chemotherapy of muscle-invasive bladder cancer. Methods and Materials: A standard logistic dose–response curve was fitted to data from radiation therapy-alone trials and then used as the platform from which to quantify the chemotherapy contribution in 1-phase radio-chemotherapy trials. Two possible mechanisms of chemotherapy effect were assumed (1) a fixed radiation-independent contribution to local control; or (2) a fixed degree of chemotherapy-induced radiosensitization. A combination of both mechanisms was also considered. Results: The respective best-fit values of the independent chemotherapy-induced completemore » response (CCR) and radiosensitization (s) coefficients were 0.40 (95% confidence interval −0.07 to 0.87) and 1.30 (95% confidence interval 0.86-1.70). Independent chemotherapy effect was slightly favored by the analysis, and the derived CCR value was consistent with reports of pathologic complete response rates seen in neoadjuvant chemotherapy-alone treatments of muscle-invasive bladder cancer. The radiation equivalent of the CCR was 36.3 Gy. Conclusion: Although the data points in the analyzed radio-chemotherapy studies are widely dispersed (largely on account of the diverse range of chemotherapy schedules used), it is nonetheless possible to fit plausible-looking response curves. The methodology used here is based on a standard technique for analyzing dose-response in radiation therapy-alone studies and is capable of application to other mixed-modality treatment combinations involving radiation therapy.« less

Phase II Study of Neoadjuvant Anthracycline-Based Regimens Combined With Nanoparticle Albumin-Bound Paclitaxel and Trastuzumab for Human Epidermal Growth Factor Receptor 2-Positive Operable Breast Cancer.

PubMed

Tanaka, Satoru; Iwamoto, Mitsuhiko; Kimura, Kosei; Matsunami, Nobuki; Morishima, Hirotaka; Yoshidome, Katsuhide; Nomura, Takashi; Morimoto, Takashi; Yamamoto, Daigo; Tsubota, Yu; Kobayashi, Toshihiro; Uchiyama, Kazuhisa

2015-06-01

We treated patients with operable human epidermal growth factor receptor 2-positive breast cancer with neoadjuvant anthracycline regimens followed by nanoparticle albumin-bound paclitaxel plus trastuzumab. Of the 44 patients, 49% achieved a pathologic complete response (pCR). The pCR rate was 36% and 71% in the patients with estrogen receptor-positive and -negative cancer, respectively. Neoadjuvant therapy using this combination appears to be effective and safe. Introduction: Neoadjuvant chemotherapy plus trastuzumab. Neoadjuvant chemotherapy plus trastuzumab results in a 30% to 50% pathologic complete response (pCR) rate in human epidermal growth factor receptor 2 (HER2)-positive breast cancer and has been associated with improved therapeutic outcomes. Thus, the pCR rate can be useful in evaluating novel agents in this patient population. Nanoparticle albumin-bound (nab)-paclitaxel (PTX) can reduce the toxicity of PTX while maintaining its efficacy. The present study evaluated the activity and safety of nab-PTX as a neoadjuvant treatment of HER2(+) breast cancer. We treated patients with stage I to IIIA breast cancer using neoadjuvant epirubicin/cyclophosphamide (EC) or 5-fluorouracil/epirubicin/cyclophosphamide every 3 weeks (q3w) for 4 cycles, followed by nab-PTX (260 mg/m(2)) plus trastuzumab q3w for 4 cycles. The primary endpoint was the pCR rate. The secondary endpoints included the clinical response rate, disease-free survival, pathologic response rate (defined as pCR or minimal residual invasive disease only in the breast), breast-conserving surgery rate, and safety. Forty-six patients were enrolled. One patient met the exclusion criteria because of the coexistence of another malignant disease; therefore, we evaluated 45 patients in the entire study. One patient experienced rapid disease progression during EC therapy, leaving 44 patients evaluable for nab-PTX treatment. Of the 45 patients, 49% achieved a pCR. The pCR rate was 36% and 71% in those with estrogen receptor-positive and -negative cancer, respectively. Of all the study treatments, the most frequent reason for delay or dose reduction was hematologic toxicity; only 1 patient required a dose reduction for nab-PTX because of peripheral neuropathy. Neoadjuvant therapy using this combination appears to be effective and safe. Copyright © 2015 Elsevier Inc. All rights reserved.

Cyclophosphamide, thalidomide, and dexamethasone as induction therapy for newly diagnosed multiple myeloma patients destined for autologous stem-cell transplantation: MRC Myeloma IX randomized trial results

PubMed Central

Morgan, Gareth J.; Davies, Faith E.; Gregory, Walter M.; Bell, Sue E.; Szubert, Alexander J.; Navarro Coy, Nuria; Cook, Gordon; Feyler, Sylvia; Johnson, Peter R.E.; Rudin, Claudius; Drayson, Mark T.; Owen, Roger G.; Ross, Fiona M.; Russell, Nigel H.; Jackson, Graham H.; Child, J. Anthony

2012-01-01

Background Thalidomide is active in multiple myeloma and is associated with minimal myelosuppression, making it a good candidate for induction therapy prior to high-dose therapy with autologous stem-cell transplantation. Design and Methods Oral cyclophosphamide, thalidomide, and dexamethasone was compared with infusional cyclophosphamide, vincristine, doxorubicin, and dexamethasone in patients with newly diagnosed multiple myeloma. Results The post-induction overall response rate (≥ partial response) for the intent-to-treat population was significantly higher with cyclophosphamide-thalidomide-dexamethasone (n=555) versus cyclophosphamide-vincristine-doxorubicin-dexamethasone (n=556); 82.5% versus 71.2%; odds ratio 1.91; 95% confidence interval 1.44–2.55; P<0.0001. The complete response rates were 13.0% with cyclophosphamide-thalidomide-dexamethasone and 8.1% with cyclophos-phamide-vincristine-doxorubicin-dexamethasone (P=0.0083), with this differential response being maintained in patients who received autologous stem-cell transplantation (post-transplant complete response 50.0% versus 37.2%, respectively; P=0.00052). Cyclophosphamide-thalidomide-dexamethasone was non-inferior to cyclophosphamide-vincristine-doxorubicin-dexamethasone for progression-free and overall survival, and there was a trend toward a late survival benefit with cyclophosphamide-thalidomide-dexamethasone in responders. A trend toward an overall survival advantage for cyclophosphamide-thalidomide-dexamethasone over cyclophosphamide-vincristine-doxorubicin-dexamethasone was also observed in a subgroup of patients with favorable interphase fluorescence in situ hybridization. Compared with cyclophosphamide-vincristine-doxorubicin-dexamethasone, cyclophosphamide-thalidomide-dexamethasone was associated with more constipation and somnolence, but a lower incidence of cytopenias. Conclusions The cyclophosphamide-thalidomide-dexamethasone regimen showed improved response rates and was not inferior in terms of survival outcomes to the standard infusional regimen of cyclophosphamide-vincristine-doxorubicin-dexamethasone. Based on its oral administration and the reduced incidence of infection and cytopenia, cyclophosphamide-thalidomide-dexa-methasone may be considered an effective induction therapy option for patients with newly diagnosed multiple myeloma. (ISRCTN: 68454111) PMID:22058209

[Adriamycin, cyclophosphamide, ftorafur and tamoxifen (ACFT) in patients with advanced breast cancer].

PubMed

Imajo, K; Ogawa, M; Horikoshi, N; Inoue, K; Mukaiyama, T; Ozeki, H; Nagamine, D; Shinagawa, K; Fukutani, H

1988-01-01

One hundred and six patients with advanced breast cancer were treated with chemoendocrine therapy consisting of adriamycin (40 mg/m2) i.v. on day 1 and cyclophosphamide (130 mg/m2) i.v. daily for 5 days every 3 weeks, ftorafur (500 mg/m2) and tamoxifen (40 mg) orally daily. Of 82 evaluable patients, 16 showed complete response (20%), 32 partial response (39%), 32 no change (39%), and two progressive disease (2%). The overall response rate was 59%, and the median duration of response was 16.3 (3.5-67+) months with a median survival time from the start of chemoendocrine therapy of 25.5 (3.5-67+) months. The median survival time of responders (32.5 months) was significantly longer than that of non-responders (15.3 months). The major toxicities were hair loss, G1 symptoms, and hematological toxicity, but these were clinically well tolerated. No serious cardiac, renal or liver damage was seen. These results indicated that the addition of tamoxifen to the ACF regimen increased the number of complete responses and prolonged the survival time of responders.

Physiologic responses to forward and retrograde simulated stair stepping.

PubMed

Ryan, P T; Plowman, S A; Ball, T E; Looney, M A

1994-07-01

This study compared the physiologic responses to forward and retrograde simulated stair stepping on the StairMaster 4000 PT. Twenty male subjects (mean age 23.65 +/- 1.63 years) volunteered for this study. Subjects completed a practice trial of 6 minutes of both forward and retrograde stepping at Level 5. Each experimental trial was divided into four 3-minute stages: Level 3, Level 5, Level 7, and Level 9. Heart rate, blood pressure, and rating of perceived exertion (RPE) were recorded during the second minute of each stage. Expired gases were analyzed and averaged over the last 2 minutes of each stage. Caloric expenditure and delta efficiency were later calculated. Data were analyzed using a 2 x 4 ANOVA (direction by level) and 2 x 3 ANOVA (for delta efficiency). Compared to forward responses, retrograde heart rates were significantly higher at Levels 7 and 9 (p < 0.01). Retrograde responses for RPE, metabolic equivalents (METS), and caloric expenditure were significantly higher at (p < 0.01) Levels 5, 7, and 9 when compared to forward responses. However, the results of this study show that these differences between forward and retrograde stepping are not practically meaningful.

Meta-analysis on the association between pathologic complete response and triple-negative breast cancer after neoadjuvant chemotherapy.

PubMed

Wu, Kunpeng; Yang, Qiaozhu; Liu, Yi; Wu, Aibing; Yang, Zhixiong

2014-04-15

Triple-negative breast cancer (TNBC) is a special subtype of breast cancer that is characterized by poor prognosis, strong tumor invasion and a high pathologic complete response (pCR) to neoadjuvant chemotherapy (NAC). The pCR rate is a prognostic factor for TNBC. We aimed to evaluate the relationship between pCR and TNBC after NAC and originally tried to identify factors related to achieving pCR for TNBC using a meta-analysis. We systematically searched the literature for pCR and breast cancer after NAC and carefully identified eligibility criteria. The association between pCR and breast cancer subtypes was estimated using Review Manager, while pCR rates for TNBC and non-TNBC were determined using Meta-Analyst. This analysis included a total of 9,460 cases from 27 studies. The summary odds ratio estimating the relationship between pCR and breast cancer subtypes (TNBC vs non-TNBC) was 3.02 (95% confidence interval (CI), 2.66 to 3.42). The TNBC pCR rate was 28.9% (95% CI, 27.0 to 30.8%) and the non-TNBC was 12.5% (95% CI, 11.7 to 13.4%). From subgroup analyses, we identified the factors associated with the highest pCR rates for TNBC. TNBC has a higher pCR rate than non-TNBC. In the NAC setting, these factors of platinum-containing, more than six cycles, four kinds of drugs, 16 weeks' treatment duration and sequential chemotherapy may contribute to increasing the pCR rate.

Low-Dose Palliative Radiotherapy for Cutaneous B- and T-Cell Lymphomas

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

Neelis, Karen J.; Schimmel, Erik C.; Vermeer, Maarten H.

Purpose: To determine the efficacy of low-dose palliative radiotherapy for both low-grade malignant cutaneous B-cell lymphomas (CBCLs) and cutaneous T-cell lymphomas (mycosis fungoides). Methods and Materials: A total of 18 patients with low-grade CBCL (10 primary cutaneous marginal zone B-cell and 8 primary cutaneous follicle center lymphomas) with 44 symptomatic plaques and tumors underwent low-dose (4 Gy in two fractions) local radiotherapy. A total of 31 patients with mycosis fungoides were treated at 82 symptomatic sites, initially with 4 Gy and later with 8 Gy in two fractions. Results: The complete response rate for CBCL lesions was 72%. Of themore » 44 B-cell lymphoma lesions, 13 were re-treated to the same site after a median of 6.3 months because of persistent (n = 8) or recurrent (n = 5) symptomatic disease. Of the mycosis fungoides patients treated with 4 Gy in two fractions (17 lesions), 70% failed to respond. Increasing the dose to 8 Gy in two fractions yielded a complete response rate of 92% (60 of 65 lesions). The patients in whom low-dose radiotherapy failed were retreated with 20 Gy in eight fractions. Conclusion: Our results have demonstrated that low-dose involved-field radiotherapy induces a high response rate in both CBCL and cutaneous T-cell lymphoma lesions without any toxicity. Therefore, this treatment is now our standard palliative treatment. At progression, it is safe and feasible to apply greater radiation doses.« less

Comparing peak and submaximal cardiorespiratory responses during field walking tests with incremental cycle ergometry in COPD.

PubMed

Hill, Kylie; Dolmage, Thomas E; Woon, Lynda; Coutts, Debbie; Goldstein, Roger; Brooks, Dina

2012-02-01

Field and laboratory-based tests are used to measure exercise capacity in people with COPD. A comparison of the cardiorespiratory responses to field tests, referenced to a laboratory test, is needed to appreciate the relative physiological demands. We sought to compare peak and submaximal cardiorespiratory responses to the 6-min walk test, incremental shuttle walk test and endurance shuttle walk test with a ramp cycle ergometer test (CET) in patients with COPD. Twenty-four participants (FEV(1) 50 ± 14%; 66.5 ± 7.7 years; 15 men) completed four sessions, separated by ≥24 h. During an individual session, participants completed either two 6-min walk tests, incremental shuttle walk tests, endurance shuttle walk tests using standardized protocols, or a single CET, wearing a portable gas analysis unit (Cosmed K4b(2)) which included measures of heart rate and arterial oxygen saturation (SpO(2)). Between tests, no difference was observed in the peak rate of oxygen uptake (F(3,69) = 1.2; P = 0.31), end-test heart rate (F(2,50) = 0.6; P = 0.58) or tidal volume (F(3,69) = 1.5; P = 0.21). Compared with all walking tests, the CET elicited a higher peak rate of carbon dioxide output (1173 ± 350 mL/min; F(3,62) = 4.8; P = 0.006), minute ventilation (48 ± 17 L/min; F(3,69) = 10.2; P < 0.001) and a higher end-test SpO(2) (95 ± 4%; F(3,63) = 24.9; P < 0.001). In patients with moderate COPD, field walking tests elicited a similar peak rate of oxygen uptake and heart rate as a CET, demonstrating that both self- and externally paced walking tests progress to high intensities. © 2011 The Authors. Respirology © 2011 Asian Pacific Society of Respirology.

Emotion processing deficits in alexithymia and response to a depth of processing intervention.

PubMed

Constantinou, Elena; Panayiotou, Georgia; Theodorou, Marios

2014-12-01

Findings on alexithymic emotion difficulties have been inconsistent. We examined potential differences between alexithymic and control participants in general arousal, reactivity, facial and subjective expression, emotion labeling, and covariation between emotion response systems. A depth of processing intervention was introduced. Fifty-four participants (27 alexithymic), selected using the Toronto Alexithymia Scale-20, completed an imagery experiment (imagining joy, fear and neutral scripts), under instructions for shallow or deep emotion processing. Heart rate, skin conductance, facial electromyography and startle reflex were recorded along with subjective ratings. Results indicated hypo-reactivity to emotion among high alexithymic individuals, smaller and slower startle responses, and low covariation between physiology and self-report. No deficits in facial expression, labeling and emotion ratings were identified. Deep processing was associated with increased physiological reactivity and lower perceived dominance and arousal in high alexithymia. Findings suggest a tendency for avoidance of intense, unpleasant emotions and less defensive action preparation in alexithymia. Copyright © 2014 Elsevier B.V. All rights reserved.

Circulatory Responses to Asphyxia Differ if the Asphyxia Occurs In Utero or Ex Utero in Near-Term Lambs

PubMed Central

Sobotka, Kristina S.; Morley, Colin; Ong, Tracey; Polglase, Graeme R.; Aridas, James D. S.; Miller, Suzanne L.; Schmölzer, Georg M.; Klingenberg, Claus; Moss, Timothy J. M.; Jenkin, Graham; Hooper, Stuart B.

2014-01-01

Background A cornerstone of neonatal resuscitation teaching suggests that a rapid vagal-mediated bradycardia is one of the first signs of perinatal compromise. As this understanding is based primarily on fetal studies, we investigated whether the heart rate and blood pressure response to total asphyxia is influenced by whether the animal is in utero or ex utero. Methods Fetal sheep were instrumented at ∼139 days of gestation and then asphyxiated by umbilical cord occlusion until mean arterial blood pressure decreased to ∼20 mmHg. Lambs were either completely submerged in amniotic fluid (in utero; n = 8) throughout the asphyxia or were delivered and then remained ex utero (ex utero; n = 8) throughout the asphyxia. Heart rate and arterial blood pressure were continuously recorded. Results Heart rate was higher in ex utero lambs than in utero lambs. Heart rates in in utero lambs rapidly decreased, while heart rates in ex utero lambs initially increased following cord occlusion (for ∼1.5 min) before they started to decrease. Mean arterial pressure initially increased then decreased in both groups. Conclusions Heart rate response to asphyxia was markedly different depending upon whether the lamb was in utero or ex utero. This indicates that the cardiovascular responses to perinatal asphyxia are significantly influenced by the newborn's local environment. As such, based solely on heart rate, the stage and severity of a perinatal asphyxic event may not be as accurate as previously assumed. PMID:25393411

Circulatory responses to asphyxia differ if the asphyxia occurs in utero or ex utero in near-term lambs.

PubMed

Sobotka, Kristina S; Morley, Colin; Ong, Tracey; Polglase, Graeme R; Aridas, James D S; Miller, Suzanne L; Schmölzer, Georg M; Klingenberg, Claus; Moss, Timothy J M; Jenkin, Graham; Hooper, Stuart B

2014-01-01

A cornerstone of neonatal resuscitation teaching suggests that a rapid vagal-mediated bradycardia is one of the first signs of perinatal compromise. As this understanding is based primarily on fetal studies, we investigated whether the heart rate and blood pressure response to total asphyxia is influenced by whether the animal is in utero or ex utero. Fetal sheep were instrumented at ∼ 139 days of gestation and then asphyxiated by umbilical cord occlusion until mean arterial blood pressure decreased to ∼ 20 mmHg. Lambs were either completely submerged in amniotic fluid (in utero; n = 8) throughout the asphyxia or were delivered and then remained ex utero (ex utero; n = 8) throughout the asphyxia. Heart rate and arterial blood pressure were continuously recorded. Heart rate was higher in ex utero lambs than in utero lambs. Heart rates in in utero lambs rapidly decreased, while heart rates in ex utero lambs initially increased following cord occlusion (for ∼ 1.5 min) before they started to decrease. Mean arterial pressure initially increased then decreased in both groups. Heart rate response to asphyxia was markedly different depending upon whether the lamb was in utero or ex utero. This indicates that the cardiovascular responses to perinatal asphyxia are significantly influenced by the newborn's local environment. As such, based solely on heart rate, the stage and severity of a perinatal asphyxic event may not be as accurate as previously assumed.

Retreatment with interferon plus ribavirin of chronic hepatitis C non-responders to interferon monotherapy: a meta-analysis of individual patient data

PubMed Central

Cammà, C; Bruno, S; Schepis, F; Lo Iacono, O; Andreone, P; Gramenzi, A G; Mangia, A; Andriulli, A; Puoti, M; Spadaro, A; Freni, M; Di Marco, V; Cino, L; Saracco, G; Chiesa, A; Crosignani, A; Caporaso, N; Morisco, F; Rumi, M G; Craxì, A

2002-01-01

Background and aims: Retreatment with a combination of α interferon (IFN) plus ribavirin of patients with chronic hepatitis C who did not respond to IFN monotherapy has not been assessed in large controlled studies. Methods: To assess the effectiveness and tolerability of IFN/ribavirin retreatment of non-responders to IFN and to identify predictors of complete (biochemical and virological) sustained response, we performed a meta-analysis of individual data on 581 patients from 10 centres. Retreatment with various IFN schedules (mean total dose 544 mega units) and a fixed ribavirin dose (1000–1200 mg/daily depending on body weight) was given for 24–60 (mean 39.5) weeks. Results: Biochemical end of treatment and sustained responses were observed in 271/581 (46.6%; 95% confidence interval (CI) 42.6–50.7%) and in 109/581 (18.7%; 95% CI 15.6–22.0%) cases, respectively. Two hundred and six of 532 patients (38.7%; 95% CI 34.6–42.9%) had an end of treatment complete response to retreatment while a complete sustained response occurred in 88 of 559 (15.7%; 95% CI 12.8–18.8%). Fifty four of 581 patients (9.2%; 95% CI 7.0–11.7%) stopped retreatment due to adverse effects. By logistic regression, complete sustained response was predicted independently by age <45 years (p=0.04), by normal pretreatment γ-glutamyltransferase levels (p=0.01), and by a second course total IFN dose of at least 432 mega units (p=0.008). Conclusions: The overall low probability of effectiveness argues against indiscriminate retreatment of all IFN monotherapy non-responders with IFN/ribavirin. Patients less than 45 years old with normal γ-glutamyltransferase levels who were retreated with high dose long course combination therapy had a complete sustained response rate of 30%. PMID:12427791

Durable Complete Responses in Some Recurrent High Grade Glioma Patients Treated with Toca 511 & Toca FC.

PubMed

Cloughesy, Timothy F; Landolfi, Joseph; Vogelbaum, Michael A; Ostertag, Derek; Elder, James B; Bloomfield, Stephen; Carter, Bob; Chen, Clark C; Kalkanis, Steven N; Kesari, Santosh; Lai, Albert; Lee, Ian Y; Liau, Linda M; Mikkelsen, Tom; Nghiemphu, Phioanh; Piccioni, David; Accomando, William; Diago, Oscar R; Hogan, Daniel J; Gammon, Dawn; Kasahara, Noriyuki; Kheoh, Thian; Jolly, Douglas J; Gruber, Harry E; Das, Asha; Walbert, Tobias

2018-05-12

Vocimagene amiretrorepvec (Toca 511) is an investigational gamma-retroviral replicating vector encoding cytosine deaminase that, when used in combination with extended-release 5-fluorocytosine (Toca FC), results preclinically in local production of 5-fluorouracil, depletion of immune-suppressive myeloid cells, and subsequent induction of anti-tumor immunity. Recurrent high grade glioma (rHGG) patients have a high unmet need for effective therapies that produce durable responses lasting more than 6 months. In this setting, relapse is nearly universal and most responses are transient. In this Toca 511 ascending-dose phase I trial (NCT01470794), HGG patients who recurred after standard of care underwent surgical resection, received Toca 511 injected into resection cavity wall followed by orally administered cycles of Toca FC. Among 56 patients, durable complete responses were observed. A subgroup was identified based on Toca 511 dose and entry requirements for the follow-up phase III study. In this subgroup, which included both IDH1-mutant and -wildtype tumors, the durable response rate is 21.7%. Median duration of follow-up for responders is 35.7+ months. As of August 25, 2017, all responders remain in response and are alive, 33.9+ to 52.2+ months after Toca 511 administration, suggesting a positive association of durable response with overall survival. Multi-year durable responses have been observed in rHGG patients treated with Toca 511 & Toca FC in a phase I trial and the treatment will be further evaluated in a randomized phase III trial. Among IDH1 mutant patients treated at first recurrence, there may be an enrichment of complete responders.

A population management system for improving colorectal cancer screening in a primary care setting.

PubMed

Wu, Charlotte A; Mulder, Amara L; Zai, Adrian H; Hu, Yuanshan; Costa, Manuela; Tishler, Lori Wiviott; Saltzman, John R; Ellner, Andrew L; Bitton, Asaf

2016-06-01

Provision of colorectal cancer (CRC) screening in primary care is suboptimal; failure to observe screening guidelines poses unnecessary risks to patients and doctors. Implement a population management system for CRC screening; evaluate impact on compliance with evidence-based guidelines. A quasi-experimental, prospective quality improvement study design using pre-post-analyses with concurrent controls. Six suites within an academic primary care practice. 5320 adults eligible for CRC screening treated by 70 doctors. In three intervention suites, doctors reviewed real-time rosters of patients due for CRC screening and chose practice delegate outreach or default reminder letter. Delegates tracked overdue patients, made outreach calls, facilitated test ordering, obtained records and documented patient deferral, exclusion or decline. In three control suites, doctors followed usual preventive care practices. CRC screening compliance (including documented decline, deferral or exclusion) and CRC screening completion rates over 5 months. At baseline, there was no significant difference in CRC screening compliance (I: 80.4% and C: 79.6%, P = 0.439) and CRC screening completion rates (I: 78.3% and C: 77.3%, P = 0.398) between intervention and control groups. Post-intervention, compliance rates (I: 88.1% and C: 80.5%, P < 0.01) and completion rates (I: 81.0% and C: 78.1%, P < 0.05) were significantly higher in the intervention group. A population management system using closed-loop communication may improve CRC screening compliance and completion rates within academic primary care practices. Team-based care using well-designed IT systems can enable sharing of patient care responsibilities and improve patient outcomes. © 2015 John Wiley & Sons, Ltd.

Achieving deeper molecular response is associated with a better clinical outcome in chronic myeloid leukemia patients on imatinib front-line therapy

PubMed Central

Etienne, Gabriel; Dulucq, Stéphanie; Nicolini, Franck-Emmanuel; Morisset, Stéphane; Fort, Marie-Pierre; Schmitt, Anna; Etienne, Madeleine; Hayette, Sandrine; Lippert, Eric; Bureau, Caroline; Tigaud, Isabelle; Adiko, Didier; Marit, Gérald; Reiffers, Josy; Mahon, François-Xavier

2014-01-01

Sustained imatinib treatment in chronic myeloid leukemia patients can result in complete molecular response allowing discontinuation without relapse. We set out to evaluate the frequency of complete molecular response in imatinib de novo chronic phase chronic myeloid leukemia patients, to identify base-line and under-treatment predictive factors of complete molecular response in patients achieving complete cytogenetic response, and to assess if complete molecular response is associated with a better outcome. A random selection of patients on front-line imatinib therapy (n=266) were considered for inclusion. Complete molecular response was confirmed and defined as MR 4.5 with undetectable BCR-ABL transcript levels. Median follow up was 4.43 years (range 0.79–10.8 years). Sixty-five patients (24%) achieved complete molecular response within a median time of 32.7 months. Absence of spleen enlargement at diagnosis, achieving complete cytogenetic response before 12 months of therapy, and major molecular response during the year following complete cytogenetic response was predictive of achieving further complete molecular response. Patients who achieved complete molecular response had better event-free and failure-free survivals than those with complete cytogenetic response irrespective of major molecular response status (95.2% vs. 64.7% vs. 27.7%, P=0.00124; 98.4% vs. 82.3% vs. 56%, P=0.0335), respectively. Overall survival was identical in the 3 groups. In addition to complete cytogenetic response and major molecular response, further deeper molecular response is associated with better event-free and failure-free survivals, and complete molecular response confers the best outcome. PMID:24362549

The effect of carbohydrate mouth rinse on performance, biochemical and psychophysiological variables during a cycling time trial: a crossover randomized trial.

PubMed

Ferreira, Amanda M J; Farias-Junior, Luiz F; Mota, Thaynan A A; Elsangedy, Hassan M; Marcadenti, Aline; Lemos, Telma M A M; Okano, Alexandre H; Fayh, Ana P T

2018-01-01

The hypothesis of the central effect of carbohydrate mouth rinse (CMR) on performance improvement in a fed state has not been established, and its psychophysiological responses have not yet been described. The aim of this study was to evaluate the effect of CMR in athletes fed state on performance, biochemical and psychophysiological responses compared to ad libitum water intake. Eleven trained male cyclists completed a randomized, crossover trial, which consisted of a 30 km cycle ergometer at self-selected intensity and in a fed state. Subjects were under random influence of the following interventions: CMR with a 6% unflavored maltodextrin solution; mouth rinsing with a placebo solution (PMR); drinking "ad libitum" (DAL). The time for completion of the test (min), heart rate (bpm) and power (watts), rating of perceived exertion (RPE), affective response, blood glucose (mg/dL) and lactate (mmol/DL), were evaluated before, during and immediately after the test, while insulin (uIL/mL), cortisol (μg/dL) and creatine kinase (U/L) levels were measured before, immediately after the test and 30 min after the test. Time for completion of the 30 km trial did not differ significantly among CMR, PMR and DAL interventions (means = 54.5 ± 2.9, 54.7 ± 2.9 and 54.5 ± 2.5 min, respectively; p  = 0.82). RPE and affective response were higher in DAL intervention ( p  < 0.01). Glucose, insulin, cortisol and creatine kinase responses showed no significant difference among interventions. In a fed state, CMR has not caused metabolic changes, and it has not improved physical performance compared to ad libitum water intake, but demonstrated a possible central effect. ReBec registration number: RBR-4vpwkg. Available in http://www.ensaiosclinicos.gov.br/rg/?q=RBR-4vpwkg.

The effect of two lottery-style incentives on response rates to postal questionnaires in a prospective cohort study in preschool children at high risk of asthma: a randomized trial.

PubMed

van der Mark, Lonneke B; van Wonderen, Karina E; Mohrs, Jacob; Bindels, Patrick Je; Puhan, Milo A; Ter Riet, Gerben

2012-12-18

In research with long-term follow-up and repeated measurements, quick and complete response to questionnaires helps ensure a study's validity, precision and efficiency. Evidence on the effect of non-monetary incentives on response rates in observational longitudinal research is scarce. To study the impact of two strategies to enhance completeness and efficiency in observational cohort studies with follow-up durations of around 2 years. METHOD AND INTERVENTION: In a factorial design, 771 children between 2 and 5 years old and their parents participating in a prospective cohort study were randomized to three intervention groups and a control group. Three types of lotteries were run: (i) daytrip tickets for the whole family to a popular amusement park if they returned all postal questionnaires, (ii) €12.50-worth gift vouchers for sending back the questionnaire on time after each questionnaire round and (iii) a combination of (i) and (ii). Primary outcome was the proportion of participants who returned all questionnaires without any reminder. Secondary outcomes were '100% returned with or without reminder', 'probability of 100% non-response', 'probability of withdrawal', 'proportion of returned questionnaires' and 'overall number of reminders sent'. After testing for interaction between the two lottery interventions, the two trials were analysed separately. We calculated risk differences (RD) and numbers needed to "treat" and their 95% confidence intervals. Daytrip nor voucher intervention had an effect on the proportion of participants who returned all questionnaires (RD -0.01; 95% CI-0.07 - 0.06) and (RD 0.02; 95% CI-0.50 - 0.08), respectively. No effects were found on the secondary outcomes. Our findings do not support the idea that lottery-style incentives lead to more complete response to postal questionnaires in observational cohort studies with repeated data collection and follow-up durations of around 2 years.

Fotemustine for the treatment of melanoma.

PubMed

Quéreux, Gaëlle; Dréno, Brigitte

2011-12-01

Melanoma is a rare but very aggressive form of cancer. Survival in melanoma varies widely depending on the stage of the tumor. In metastatic melanoma, prognosis is usually poor and the treatment is based on chemotherapy. So far, dacarbazine has been the drug of reference, with an average response rate of 15 - 20% when used as a monotherapy. As single drugs go, fotemustine is considered the second-best treatment, after dacarbazine. This review of the scientific literature focuses on the use of fotemustine in patients with cutaneous melanoma and discusses its clinical efficacy and safety. Fotemustine is a nitrosurea that has proved its efficacy in metastatic melanoma and particularly on cerebral metastases, given its high lipophilicity, facilitating its active penetration in all tissues including the central nervous system. However, overall response rates are low, with only few complete remissions and short response durations.

Exploratory Cross-Sectional Study of Factors Associated with the Healthfulness of Parental Responses to Child Food Purchasing Requests.

PubMed

Calloway, Eric E; Ranjit, Nalini; Sweitzer, Sara J; Roberts-Gray, Cindy; Romo-Palafox, Maria J; McInnis, Katie A; Briley, Margaret E

2016-08-01

Objective The main objective of this study was to investigate the relationship between various factors (e.g., sociodemographic, child, and parental factors) and the healthfulness of parental responses to child in-store food purchasing requests. Additionally, a secondary objective is to describe "resist strategies" used by parents to respond to child food-purchasing requests and their efficacy in avoiding conflict. Methods Parent-child dyads (children aged 2-6 years) completed an audio-/visual-recoded food shopping trip at their usual grocery store and time. Recordings of trips were coded for behavioral and environmental factors. Parental healthful response rate (i.e., percent of responses that were healthful) was the primary outcome variable. A healthful response occurred when a parent yielded to a healthful child request, or resisted a non-healthful request. Parents also completed a questionnaire. Kruskal-Wallis tests were used to assess the relationship between the main outcome variable and sociodemographic, child, and parent factors. Results Parents (n = 39) responded healthfully to 62.9 % (±26.7 %) of child food purchasing requests. Low- and middle-income parents, and black and white parents, had significantly higher healthful response rates compared to high-income parents (p = 0.03) and Hispanic/Indian-descent parents (p = 0.02), respectively. Using the "ignore" strategy proved an effective resist strategy in this study, leading to no parent-child conflicts. Conclusions Programming that seeks to improve the healthfulness of food purchasing in families with young children should address unhealthful response behaviors in Hispanic/Indian-descent parents and high-income parents; although, the needs of these groups are different. Further research is needed to confirm and expand on these findings.

Appetite and Energy Intake Responses to Acute Energy Deficits in Females versus Males

PubMed Central

ALAJMI, NAWAL; DEIGHTON, KEVIN; KING, JAMES A.; REISCHAK-OLIVEIRA, ALVARO; WASSE, LUCY K.; JONES, JENNY; BATTERHAM, RACHEL L.; STENSEL, DAVID J.

2016-01-01

ABSTRACT Purpose To explore whether compensatory responses to acute energy deficits induced by exercise or diet differ by sex. Methods In experiment one, 12 healthy women completed three 9-h trials (control, exercise-induced (Ex-Def) and food restriction–induced energy deficit (Food-Def)) with identical energy deficits being imposed in the Ex-Def (90-min run, ∼70% of V˙O2max) and Food-Def trials. In experiment two, 10 men and 10 women completed two 7-h trials (control and exercise). Sixty minutes of running (∼70% of V˙O2max) was performed at the beginning of the exercise trial. The participants rested throughout the remainder of the exercise trial and during the control trial. Appetite ratings, plasma concentrations of gut hormones, and ad libitum energy intake were assessed during main trials. Results In experiment one, an energy deficit of approximately 3500 kJ induced via food restriction increased appetite and food intake. These changes corresponded with heightened concentrations of plasma acylated ghrelin and lower peptide YY3–36. None of these compensatory responses were apparent when an equivalent energy deficit was induced by exercise. In experiment two, appetite ratings and plasma acylated ghrelin concentrations were lower in exercise than in control, but energy intake did not differ between trials. The appetite, acylated ghrelin, and energy intake response to exercise did not differ between men and women. Conclusions Women exhibit compensatory appetite, gut hormone, and food intake responses to acute energy restriction but not in response to an acute bout of exercise. Additionally, men and women seem to exhibit similar acylated ghrelin and PYY3–36 responses to exercise-induced energy deficits. These findings advance understanding regarding the interaction between exercise and energy homeostasis in women. PMID:26465216

Evaluating the interplay between spirituality, personality and stress.

PubMed

Labbé, Elise E; Fobes, Ashley

2010-06-01

Spirituality and the big five personality traits may be risk or protective factors for coping with stress. We hypothesized young adults who reported higher spirituality ratings would demonstrate lower sympathetic nervous system arousal and better emotional coping when exposed to a laboratory stressor compared to those who rated themselves lower in spirituality. We also compared spirituality groups on trait anger, neuroticism, conscientiousness, extraversion, agreeableness and openness to experience. Eighty participants completed trait-state anger, personality and spirituality questionnaires and were grouped into low, average and high spirituality. Participants' physiological responses were monitored before and during a stressful event. Significant differences were found between low, average and high spirituality groups' respiration rate and emotional response to the stressor. Significant differences were also found between spirituality groups in extraversion, agreeableness, conscientiousness, trait anger and neuroticism. Females reported higher levels of spirituality and conscientiousness than males.

Fludarabine plus alemtuzumab (FA) front-line treatment in young patients with chronic lymphocytic leukemia (CLL) and an adverse biologic profile.

PubMed

Mauro, Francesca R; Molica, Stefano; Laurenti, Luca; Cortelezzi, Agostino; Carella, Angelo M; Zaja, Francesco; Chiarenza, Annalisa; Angrilli, Francesco; Nobile, Francesco; Marasca, Roberto; Musolino, Caterina; Brugiatelli, Maura; Piciocchi, Alfonso; Vignetti, Marco; Fazi, Paola; Gentile, Giuseppe; De Propris, Maria S; Della Starza, Irene; Marinelli, Marilisa; Chiaretti, Sabina; Del Giudice, Ilaria; Nanni, Mauro; Albano, Francesco; Cuneo, Antonio; Guarini, Anna; Foà, Robin

2014-02-01

In 45, ≤ 60 years old patients with CLL and an adverse biologic profile, a front-line treatment with Fludarabine and Campath (Alemtuzumab(®)) was given. The overall response rate was 75.5%, the complete response rate (CR) 24.4% with the lowest CR rates, 16.7% and 8.3%, in 11q and 17p deleted cases. The 3-year progression-free survival (PFS) and overall survival were 42.5% and 79.9%, respectively. PFS was significantly influenced by CLL duration, beta2-microglobulin, and improved by post-remissional stem cell transplantation. Front-line fludarabine and alemtuzumab showed a manageable safety profile and evidence of a benefit in a small series of CLL patients with adverse biologic features. Copyright © 2013 Elsevier Ltd. All rights reserved.

Determination of Heritage SSME Pogo Suppressor Resistance and Inertance from Waterflow Pulse Testing

NASA Technical Reports Server (NTRS)

McDougal, Chris; Eberhart, Chad; Lee, Erik

2016-01-01

Waterflow tests of a heritage Space Shuttle Main Engine pogo suppressor were performed to experimentally quantify the resistance and inertance provided by the suppressor. Measurements of dynamic pressure and flow rate in response to pulsing flow were made throughout the test loop. A unique system identification methodology combined all sensor measurements with a one-dimensional perturbational flow model of the complete water flow loop to spatially translate physical measurements to the device under test. Multiple techniques were then employed to extract the effective resistance and inertance for the pogo suppressor. Parameters such as steady flow rate, perturbational flow rate magnitude, and pulse frequency were investigated to assess their influence on the behavior of the pogo suppressor dynamic response. These results support validation of the RS-25 pogo suppressor performance for use on the Space Launch System Core Stage.

An open treatment trial of duloxetine in elderly patients with dysthymic disorder.

PubMed

Kerner, Nancy; D'Antonio, Kristina; Pelton, Gregory H; Salcedo, Elianny; Ferrar, Jennifer; Roose, Steven P; Devanand, Dp

2014-05-08

We evaluated the efficacy and side effects of the selective serotonin and norepinephrine reuptake inhibitor antidepressant duloxetine in older adults with dysthymic disorder. Patients ≥ 60 years old with dysthymic disorder received flexible dose duloxetine 20-120 mg daily in an open-label 12-week trial. The main outcomes were change from baseline to 12 weeks in 24-item Hamilton Depression Rating Scale scores and Treatment Emergent Symptoms Scale scores. Response required ≥ 50% decline in Hamilton Depression Rating Scale scores with a Clinical Global Impression of much improved or better, and remission required final Hamilton Depression Rating Scale ≤ 6. Intent-to-treat analyses were conducted with the last observation carried forward. In 30 patients, the mean age was 70.7 (standard deviation (SD) = 7.6) years and 56.7% were female. In intent-to-treat analyses, there were 16 responders (53.3%) and 10 remitters (33.3%). Of these, 19 patients completed the trial. The mean maximum dose was 76.3 mg (SD = 38.5) in the total sample and 101 mg (SD = 17.9) in completers. In the total sample, the mean final dose was 51 mg (SD = 27.2) and correlated significantly with decline in Hamilton Depression Rating Scale ( p < .03); decline in Hamilton Depression Rating Scale correlated significantly with decline in Treatment Emergent Symptoms Scale ( p < .001). Daily doses above 60 mg were associated with greater improvement and well tolerated. This result was partly confounded by early dropouts having received low doses. Demographic and medical comorbidities, including cardiac disease and hypertension, were not related to response. Somatic side effects were common prior to duloxetine treatment and improved rather than worsened with duloxetine. There were no serious adverse events. Duloxetine at relatively high doses showed moderate efficacy in elderly patients with dysthymic disorder and was well tolerated in successful completers. Reduced somatic symptoms were associated with improvement in depressive symptoms. A systematic placebo-controlled trial of duloxetine in older patients with dysthymic disorder may be warranted.

Faculty Use of Author Identifiers and Researcher Networking Tools

ERIC Educational Resources Information Center

Tran, Clara Y.; Lyon, Jennifer A.

2017-01-01

This cross-sectional survey focused on faculty use and knowledge of author identifiers and researcher networking systems, and professional use of social media, at a large state university. Results from 296 completed faculty surveys representing all disciplines (9.3% response rate) show low levels of awareness and variable resource preferences. The…

Access Barriers to Distance Education Perceived by Inservice and Preservice Career and Technical Education Majors.

ERIC Educational Resources Information Center

Zirkle, Chris

The access barriers to distance education faced by inservice and preservice career and technical education (CTE) majors were examined through a survey of 76 students enrolled in undergraduate- and graduate-level CTE education programs. Completed questionnaires were received from 60 students (response rate, 78.9%). Forty respondents worked…

Development, Evaluation, and Validation of Environmental Assessment Tools to Evaluate the College Nutrition Environment

ERIC Educational Resources Information Center

Freedman, Marjorie R.

2010-01-01

Objective: To develop, evaluate, and validate 2 nutrition environment assessment tools (surveys), for specific use in combating overweight on college/university campuses. Participants and Methods: Invitations to complete surveys were e-mailed to food service and health center directors at 47 universities, Winter 2008. Overall response rate was…

The Perceived Influence of Industry-Sponsored Credentials in the Information Technology Industry.

ERIC Educational Resources Information Center

Bartlett, Kenneth R.

A study investigated the influence of information technology (IT)-industry-sponsored credentials from both organizational and individual perspectives. A senior-level human resource (HR) executive from each of 33 organizations with 500 or more employees completed a paper-and-pencil questionnaire (response rate=66% of the 50 organizations comprising…

Postsecondary Education Supports for Students with Disabilities: A Review and Response.

ERIC Educational Resources Information Center

Stodden, Robert A.

2001-01-01

A literature review identified the impact of postsecondary completion on employment, the education and employment rates of people with disabilities, barriers to postsecondary education, and support and self-advocacy. Results were used to compile a research agenda for the National Center for the Study of Postsecondary Education Supports. (Contains…

Step-Families. Item 12.

ERIC Educational Resources Information Center

Webber, Ruth P.

1988-01-01

This paper describes stepfamily life; much of its content is derived from responses of 29 Australian couples who attended a six-session educational program on living in a stepfamily and who completed pre- and post-tests on marital adjustment and self-esteem plus a weekly problem rating scale. While the major part of the study was concerned with…

Behavior Management Style of Single Parents and Intact Families.

ERIC Educational Resources Information Center

Smith, Douglas K.; And Others

Studies examining the behavior management styles of parents as a function of family intactness and parent employment status are lacking. To assess parental style of behavior management, the Parental Management Questionnaire (PMQ) was completed by 1,957 parents of elementary school children (50% response rate). The PMQ is based on Aronfreed's…

Education and Child Welfare Supervisor Performance: Does a Social Work Degree Matter?

ERIC Educational Resources Information Center

Perry, Robin E.

2006-01-01

Objective: To empirically examine whether the educational background of child welfare supervisors in Florida affects performance evaluations of their work. Method: A complete population sample (yielding a 58.5% response rate) of administrator and peer evaluations of child welfare workers' supervisors. ANOVA procedures were utilized to test if…

LEADing the Way with ePortfolios in a First-Generation Learning Community

ERIC Educational Resources Information Center

Conefrey, Theresa

2017-01-01

Although an increasing number of first-generation students are beginning tertiary education, many are not completing their degrees. In an attempt to improve retention and graduation rates, learning communities responsive to the unique needs of first-generation students are becoming more common. This paper explores the implementation of ePortfolios…

Regional High School Senior Survey.

ERIC Educational Resources Information Center

Day, Philip R., Jr.

In order to identify the educational needs and aspirations of graduating high school seniors in the service region of the University of Maine at Augusta, a survey instrument was designed and administered to 1,950 seniors at 19 institutions. In all, 1,744 completed surveys were returned, a 92 percent response rate. The data are sub-grouped into…

Bullying and School Climate: Associations and Group Differences

ERIC Educational Resources Information Center

Biernbaum, Mark A.; Lotyczewski, Bohdan S.

2015-01-01

Bullying is an international public health problem that school climate could help prevent or promote. The present paper contains an analysis of an anonymous school climate survey, completed by 9554 students, in grades 5-12 (response rate 87%). Links in the literature between school climate and bullying lack specificity. We examined associations…

Negative Affective Spillover from Daily Events Predicts Early Response to Cognitive Therapy for Depression

ERIC Educational Resources Information Center

Cohen, Lawrence H.; Gunthert, Kathleen C.; Butler, Andrew C.; Parrish, Brendt P.; Wenze, Susan J.; Beck, Judith S.

2008-01-01

This study evaluated the predictive role of depressed outpatients' (N = 62) affective reactivity to daily stressors in their rates of improvement in cognitive therapy (CT). For 1 week before treatment, patients completed nightly electronic diaries that assessed daily stressors and negative affect (NA). The authors used multilevel modeling to…

Using the Health Belief Model to Predict Bystander Behavior among College Students

ERIC Educational Resources Information Center

Blavos, Alexis A.; Glassman, Tavis; Sheu, Jiunn-Jye; Diehr, Aaron; Deakins, Bethany

2014-01-01

This investigation used the Health Belief Model (HBM) to examine perceived barriers and benefits college students hold concerning medical amnesty. Researchers employed a cross-sectional research design with 369 students completing the survey (97% response rate). A path analysis revealed that college students are more likely to seek help during an…

A Descriptive Analysis of Undergraduate PETE Programs in the Central District

ERIC Educational Resources Information Center

Hetland, Kristen M.; Strand, Bradford

2010-01-01

The current study described physical education teacher education (PETE) programs at institutions located within the Central District of the United States (CDAAAHPERD). Of the 72 institutions invited to participate, 44 institutions completed the survey (58% response rate). The purpose of this study was to describe the general profile/practices of…

Universal Hepatitis B Vaccination Coverage in Children and Adolescents with Intellectual Disabilities

ERIC Educational Resources Information Center

Lin, Jin-Ding; Lin, Pei-Ying; Lin, Lan-Ping

2010-01-01

There is little information of hepatitis B vaccination coverage for people with intellectual disabilities (ID). The present paper aims to examine the completed hepatitis B vaccination coverage rate and its determinants of children and adolescents with ID in Taiwan. A cross-sectional questionnaire survey, with the entire response participants was…

Quality of routine health data collected by health workers using smartphone at primary health care in Ethiopia.

PubMed

Medhanyie, Araya Abrha; Spigt, Mark; Yebyo, Henock; Little, Alex; Tadesse, Kidane; Dinant, Geert-Jan; Blanco, Roman

2017-05-01

Mobile phone based applications are considered by many as potentially useful for addressing challenges and improving the quality of data collection in developing countries. Yet very little evidence is available supporting or refuting the potential and widely perceived benefits on the use of electronic forms on smartphones for routine patient data collection by health workers at primary health care facilities. A facility based cross sectional study using a structured paper checklist was prepared to assess the completeness and accuracy of 408 electronic records completed and submitted to a central database server using electronic forms on smartphones by 25 health workers. The 408 electronic records were selected randomly out of a total of 1772 maternal health records submitted by the health workers to the central database over a period of six months. Descriptive frequencies and percentages of data completeness and error rates were calculated. When compared to paper records, the use of electronic forms significantly improved data completeness by 209 (8%) entries. Of a total 2622 entries checked for completeness, 2602 (99.2%) electronic record entries were complete, while 2393 (91.3%) paper record entries were complete. A very small percentage of error rates, which was easily identifiable, occurred in both electronic and paper forms although the error rate in the electronic records was more than double that of paper records (2.8% vs. 1.1%). More than half of entry errors in the electronic records related to entering a text value. With minimal training, supervision, and no incentives, health care workers were able to use electronic forms for patient assessment and routine data collection appropriately and accurately with a very small error rate. Minimising the number of questions requiring text responses in electronic forms would be helpful in minimizing data errors. Copyright © 2017 Elsevier B.V. All rights reserved.

Crewmember Performance Before, During, And After Spaceflight

PubMed Central

Kelly, Thomas H; Hienz, Robert D; Zarcone, Troy J; Wurster, Richard M; Brady, Joseph V

2005-01-01

The development of technologies for monitoring the welfare of crewmembers is a critical requirement for extended spaceflight. Behavior analytic methodologies provide a framework for studying the performance of individuals and groups, and brief computerized tests have been used successfully to examine the impairing effects of sleep, drug, and nutrition manipulations on human behavior. The purpose of the present study was to evaluate the feasibility and sensitivity of repeated performance testing during spaceflight. Four National Aeronautics and Space Administration crewmembers were trained to complete computerized questionnaires and performance tasks at repeated regular intervals before and after a 10-day shuttle mission and at times that interfered minimally with other mission activities during spaceflight. Two types of performance, Digit-Symbol Substitution trial completion rates and response times during the most complex Number Recognition trials, were altered slightly during spaceflight. All other dimensions of the performance tasks remained essentially unchanged over the course of the study. Verbal ratings of Fatigue increased slightly during spaceflight and decreased during the postflight test sessions. Arousal ratings increased during spaceflight and decreased postflight. No other consistent changes in rating-scale measures were observed over the course of the study. Crewmembers completed all mission requirements in an efficient manner with no indication of clinically significant behavioral impairment during the 10-day spaceflight. These results support the feasibility and utility of computerized task performances and questionnaire rating scales for repeated measurement of behavior during spaceflight. PMID:16262187

Serotonin receptor antagonists in prophylaxis of acute and delayed emesis induced by moderately emetogenic, single-day chemotherapy: a randomized study.

PubMed

Yalçin, S; Tekuzman, G; Baltali, E; Ozişik, Y; Barişta, I

1999-02-01

In this randomized study, the efficacy of a single dose of three serotonin antagonists were compared in prophylaxis of acute and delayed vomiting induced by moderately emetogenic, single-day chemotherapy in chemotherapy-naïve patients. A total of 54 patients were entered. Eighteen patients received ondansetron, 17 received tropisetron, and 19 received granisetron. Antiemetics were administered as 15-minute intravenous infusion before chemotherapy. Complete control of acute vomiting was achieved in 38.8% with ondansetron, 58.8% with tropisetron, and 73.7% with granisetron. Major response rates were 83.3%, 82.3%, and 89.5%, respectively. For the delayed control of emesis, complete control of delayed vomiting was achieved in 38.8% with ondansetron, 52.9% with tropisetron, and 73.7% with granisetron. The major response rates were 71.8%, 70.5%, and 100%, respectively. The adverse effects were rare and mild in all groups. The authors conclude that there may be clinically important differences among serotonin antagonists used for chemotherapy-induced emesis.

A Randomized Trial of the Impact of Survey Design Characteristics on Response Rates Among Nursing Home Providers

PubMed Central

Clark, Melissa; Rogers, Michelle; Foster, Andrew; Dvorchak, Faye; Saadeh, Frances; Weaver, Jessica; Mor, Vincent

2013-01-01

An experiment was conducted to maximize participation of both the Director of Nursing (DoN) and the Administrator (ADMIN) in long-term care facilities. Providers in each of the 224 randomly selected facilities were randomly assigned to 1 of 16 conditions based on the combination of data collection mode (web vs. mail), questionnaire length (short vs. long), and incentive structure. Incentive structures were determined by amount compensated if the individual completed and an additional amount per individual if the pair completed (a) $30 individual/$5 pair/$35 total; (b) $10 individual/$25 pair/$35 total; (c) $30 individual/$20 pair/$50 total; and (d) $10 individual/$40 pair/$50 total. Overall, 47.4% of eligible respondents participated; both respondents participated in 29.3% of facilities. In multivariable analyses, there were no differences in the likelihood of both respondents participating by mode, questionnaire length, or incentive structure. Providing incentives contingent on participation by both providers of a facility was an ineffective strategy for significantly increasing response rates. PMID:21411474

[Clinical Efficacy of NOPHO-AML 2004 Regimen for Treatment of Children with Acute Myelocytic Leukemia (Non-M3)].

PubMed

Qiu, Kun-Yin; Liao, Xiong-Yu; Huang, Ke; Li, Yang; Weng, Wen-Jun; Xu, Hong-Gui; Fang, Jian-Pei; Wu, Ruo-Hao; Zhou, Dun-Hua

2018-04-01

To investigate the efficacy and safety of NOPHO-AML 2004 chemotherapy regimen for treatment of children with acute myelocytic leukemia(non-M3). Thirty-three patients aged 1-13 with acute myelocytic leukemia (non-M3) were diagnosed from January 2013 to June 2017. FAB typing showed that 1 case in M0, 4 cases in M1, 12 cases in M2, 5 cases in M4, 8 cases in M5, 1 case in M6, and 2 cases in M7; Risk stratification showed that: 19 cases in standard risk, and 14 cases in high risk. All patients were treated with NOPHO-AML 2004 chemotherapy regimen. SPSS 22.0 software was used, the Kaplan-Meier survival analysis method and Cox regression model were used for statistical analysis. In the first course of treatment (AIET), among 33 child patients there were 27 cases with complete remission, and 5 cases with non-remission, thus the remission rate was 81.8%. Out of the 5 child patients without remission, 4 cases reached to the complete remission after the second course (AM), and 1 case did not remission, thus the total remission rate was 96.9%.9 cases (27.3%) underwent bone marrow recurrence and the median recurrence time was 30 months after complete continuous remission. Univariate analysis showed that age and erythrocyte transfusion frequency were significant factors to affect the early treatment response; the multiple Cox regression analysis showed that: age >7, MRD positive, erythrocyte transfusion >4 times and poor response to early treatment were independent risk factors for recurrence; Allogeneic hematopoietic stem cell transplantation(HSCT) in 8 high-risk children received enhanced chemotherapy had better efficacy as compared with the chemotherapy alone. The 3-year event-free survival rate was 59.9%, and 3-year overall survival rate was 69.2%. 33 children patients experienced varying degrees of infection and myelosuppression, or drug-related gastrointestinal reactions and allergic reactions, patients were tolerable to these side reactions after active symptomatic treatment. NOPHO-AML 2004 chemotherapy regimen has high response rate and good tolerance, early treatment response is an important factor influencing prognosis. Age and repeated red blood cell infusions are the important factors influencing the prognosis, which promote bone marrow recurrence in AML children. For the children suffered from clinical high-risk AML, the NOPHO-AML 2004 chemotherapy regimen combined with HSCT can improve the prognosis of patients.

Examination of the equivalence of self-report survey-based paper-and-pencil and internet data collection methods.

PubMed

Weigold, Arne; Weigold, Ingrid K; Russell, Elizabeth J

2013-03-01

Self-report survey-based data collection is increasingly carried out using the Internet, as opposed to the traditional paper-and-pencil method. However, previous research on the equivalence of these methods has yielded inconsistent findings. This may be due to methodological and statistical issues present in much of the literature, such as nonequivalent samples in different conditions due to recruitment, participant self-selection to conditions, and data collection procedures, as well as incomplete or inappropriate statistical procedures for examining equivalence. We conducted 2 studies examining the equivalence of paper-and-pencil and Internet data collection that accounted for these issues. In both studies, we used measures of personality, social desirability, and computer self-efficacy, and, in Study 2, we used personal growth initiative to assess quantitative equivalence (i.e., mean equivalence), qualitative equivalence (i.e., internal consistency and intercorrelations), and auxiliary equivalence (i.e., response rates, missing data, completion time, and comfort completing questionnaires using paper-and-pencil and the Internet). Study 1 investigated the effects of completing surveys via paper-and-pencil or the Internet in both traditional (i.e., lab) and natural (i.e., take-home) settings. Results indicated equivalence across conditions, except for auxiliary equivalence aspects of missing data and completion time. Study 2 examined mailed paper-and-pencil and Internet surveys without contact between experimenter and participants. Results indicated equivalence between conditions, except for auxiliary equivalence aspects of response rate for providing an address and completion time. Overall, the findings show that paper-and-pencil and Internet data collection methods are generally equivalent, particularly for quantitative and qualitative equivalence, with nonequivalence only for some aspects of auxiliary equivalence. PsycINFO Database Record (c) 2013 APA, all rights reserved.

Intrahepatic Flow Redistribution in Patients Treated with Radioembolization

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

Spreafico, Carlo, E-mail: carlo.spreafico@istitutotumori.mi.it; Morosi, Carlo, E-mail: carlo.morosi@istitutotumori.mi.it; Maccauro, Marco, E-mail: marco.maccauro@istitutotumori.mi.it

2015-04-15

IntroductionIn planning Yttrium-90 ({sup 90}Y)-radioembolizations, strategy problems arise in tumours with multiple arterial supplies. We aim to demonstrate that tumours can be treated via one main feeding artery achieving flow redistribution by embolizing accessory vessels.MethodsOne hundred {sup 90}Y-radioembolizations were performed on 90 patients using glass microspheres. In 19 lesions/17 patients, accessory branches were found feeding a minor tumour portion and embolized. In all 17 patients, the assessment of the complete perfusion was obtained by angiography and single photon emission computerized tomography–computerized tomography (SPECT–CT). Dosimetry, toxicity, and tumor response rate of the patients treated after flow redistribution were compared with themore » 83 standard-treated patients. Seventeen lesions in 15 patients with flow redistribution were chosen as target lesions and evaluated according to mRECIST criteria.ResultsIn all patients, the complete tumor perfusion was assessed immediately before radioembolization by angiography in all patients and after the {sup 90}Y-infusion by SPECT–CT in 15 of 17 patients. In the 15 assessable patients, the response rate in their 17 lesions was 3 CR, 8 PR, and 6 SD. Dosimetric and toxicity data, as well tumour response rate, were comparable with the 83 patients with regular vasculature.ConclusionsAll embolization procedures were performed successfully with no complications, and the flow redistribution was obtained in all cases. Results in term of toxicity, median dose administered, and radiological response were comparable with standard radioembolizations. Our findings confirmed the intratumoral flow redistribution after embolizing the accessory arteries, which makes it possible to treat the tumour through its single main feeding artery.« less

A phase II trial of oxaliplatin, docetaxel, and bevacizumab as first-line therapy of advanced cancer of the ovary, peritoneum, and fallopian tube

PubMed Central

Herzog, Thomas J.; Monk, Bradley J.; Rose, Peter G.; Braly, Patricia; Hines, Jeffrey F.; Bell, Maria C.; Wenham, Robert M.; Secord, Angeles Alvarez; Roman, Lynda D.; Einstein, Mark H.; Drake, Richard D.; Childs, Barrett H.

2017-01-01

Objective To determine the safety and efficacy of the novel combination of docetaxel, oxaliplatin, and bevacizumab as first-line treatment of advanced cancer of the ovary, peritoneum or fallopian tube after initial debulking surgery. Methods Eligible patients (stage IB-IV) were treated with 6 cycles of oxaliplatin (85 mg/m2), docetaxel (75 mg/m2), and bevacizumab (15 mg/kg) every 3 weeks, followed by single-agent bevacizumab 15 mg/kg every 3 weeks to complete one year of therapy. The primary endpoint was 12-month progression-free survival (PFS). Results A total of 132 patients (80 with measurable disease at baseline; 52 with non-measurable, evaluable disease at baseline) enrolled and received study treatment. At diagnosis, 76.5% of patients had stage III disease and 20% had stage IV. 62.9% were optimally cytoreduced. The most common grade 3/4 adverse events were neutropenia (42.4%), leukopenia (13.6%), hypertension (8.3%), fatigue (6.1%), and nausea (6.1%). One patient (0.8%) had a fatal gastrointestinal perforation. The best overall confirmed response rate (complete response + partial response [measurable disease subgroup]) was 58.6% (95% CI 49%, 67%). CA-125 response rates for the measurable and non-measurable disease subgroups were 83.0% and 81.5%, respectively. The 12-month PFS rate for the measurable disease subgroup was 65.7% (95% CI 53.4%, 76.7%); median PFS was 16.3 (95% CI 12.6, 19.6) months. Median overall survival was 47.3 (95% CI 34.1, upper limit not applicable) months. Conclusions This novel treatment regimen may provide a promising therapeutic approach for women with ovarian, primary peritoneal, or fallopian tube carcinoma. No unanticipated safety concerns were identified. PMID:24476788

Parameterizing the Logistic Model of Tumor Growth by DW-MRI and DCE-MRI Data to Predict Treatment Response and Changes in Breast Cancer Cellularity during Neoadjuvant Chemotherapy1

PubMed Central

Atuegwu, Nkiruka C; Arlinghaus, Lori R; Li, Xia; Chakravarthy, A Bapsi; Abramson, Vandana G; Sanders, Melinda E; Yankeelov, Thomas E

2013-01-01

Diffusion-weighted and dynamic contrast-enhanced magnetic resonance imaging (MRI) data of 28 patients were obtained pretreatment, after one cycle, and after completion of all cycles of neoadjuvant chemotherapy (NAC). For each patient at each time point, the tumor cell number was estimated using the apparent diffusion coefficient and the extravascular extracellular (ve) and plasma volume (vp) fractions. The proliferation/death rate was obtained using the number of tumor cells from the first two time points in conjunction with the logistic model of tumor growth, which was then used to predict tumor cellularity at the conclusion of NAC. The Pearson correlation coefficient between the predicted and the experimental number of tumor cells measured at the end of NAC was 0.81 (P = .0043). The proliferation rate estimated after the first cycle of therapy was able to separate patients who went on to achieve pathologic complete response from those who did not (P = .021) with a sensitivity and specificity of 82.4% and 72.7%, respectively. These data provide preliminary results indicating that incorporating readily available quantitative MRI data into a simple model of tumor growth can lead to potentially clinically relevant information for predicting an individual patient's response to NAC. PMID:23730404

Tandem autologous non-myeloablative allogeneic transplantation in patients with multiple myeloma relapsing after a first high dose therapy.

PubMed

Karlin, L; Arnulf, B; Chevret, S; Ades, L; Robin, M; De Latour, R P; Malphettes, M; Kabbara, N; Asli, B; Rocha, V; Fermand, J P; Socie, G

2011-02-01

We retrospectively studied a series of 23 patients (median age 50 years, range 29-59 years) with multiple myeloma (MM), treated in first relapse by a sequential autologous-allogeneic tandem approach. Tandem transplantation (TT) consisted in high dose melphalan (HDT) and auto-SCT followed by an (allo-SCT) preceded by two gray TBI non-myeloablative conditioning. All patients received a first HDT as frontline treatment. At day 100 post allo-SCT, complete donor chimerism was detected in 22 patients (95%). Acute GVHD was observed in 19 patients (15 grade I-II (65%) and 4 grade III-IV (17%)). Ten patients (43%) developed an extensive chronic GVHD. The non-relapse mortality at 1 year was 17%. After TT, the overall response rate was 91% (17% partial response, 35% very good partial remission and 39% complete remission). At 2 years, OS was 61%. Median event-free survival and OS were 36.8 and 60 months, respectively. Based on the propensity score matching method, a significant survival advantage could be seen in patients treated with TT as compared with non-allografted patients. Thus, allo-SCT, in TT approach, provides a high response rate with low toxicity and may improve survival of patients with relapsing MM.

Bias in child maltreatment self-reports using Interactive Voice Response

PubMed Central

Kepple, Nancy J.; Freisthler, Bridget; Johnson-Motoyama, Michelle

2014-01-01

Few methods estimate the prevalence of child maltreatment in the general population due to concerns about socially desirable responding and mandated reporting laws. Innovative methods, such as Interactive Voice Response (IVR), may obtain better estimates that address these concerns. This study examined the utility of Interactive Voice Response (IVR) for child maltreatment behaviors by assessing differences between respondents who completed and did not complete a survey using IVR technology. A mixed-mode telephone survey was conducted in English and Spanish in 50 cities in California during 2009. Caregivers (n = 3,023) self-reported abusive and neglectful parenting behaviors for a focal child under the age of 13 using Computer-Assisted Telephone Interviewing and IVR. We used Hierarchical Generalized Linear Models to compare survey completion by caregivers nested within cities for the full sample and age-specific ranges. For demographic characteristics, caregivers born in the United States were more likely to complete the survey when controlling for covariates. Parenting stress, provision of physical needs, and provision of supervisory needs were not associated with survey completion in the full multivariate model. For caregivers of children 0 to 4 years (n = 838), those reporting they could often or always hear their child from another room had a higher likelihood of survey completion. The findings suggest IVR could prove to be useful for future surveys that aim to estimate abusive and/or neglectful parenting behaviors given the limited bias observed for demographic characteristics and problematic parenting behaviors. Further research should expand upon its utility to advance estimation rates. PMID:24819534

Real-Time Data Collection Using Text Messaging in a Primary Care Clinic.

PubMed

Rai, Manisha; Moniz, Michelle H; Blaszczak, Julie; Richardson, Caroline R; Chang, Tammy

2017-12-01

The use of text messaging is nearly ubiquitous and represents a promising method of collecting data from diverse populations. The purpose of this study was to assess the feasibility and acceptability of text message surveys in a clinical setting and to describe key lessons to minimize attrition. We obtained a convenience sample of individuals who entered the waiting room of a low-income, primary care clinic. Participants were asked to answer between 17 and 30 survey questions on a variety of health-related topics, including both open- and closed-ended questions. Descriptive statistics were used to characterize the participants and determine the response rates. Bivariate analyses were used to identify predictors of incomplete surveys. Our convenience sample consisted of 461 individuals. Of those who attempted the survey, 80% (370/461) completed it in full. The mean age of respondents was 35.4 years (standard deviation = 12.4). Respondents were predominantly non-Hispanic black (42%) or non-Hispanic white (41%), female (75%), and with at least some college education (70%). Of those who completed the survey, 84% (312/370) reported willingness to do another text message survey. Those with incomplete surveys answered a median of nine questions before stopping. Smartphone users were less likely to leave the survey incomplete compared with non-smartphone users (p = 0.004). Text-message surveys are a feasible and acceptable method to collect real-time data among low-income, clinic-based populations. Offering participants a setting for immediate survey completion, minimizing survey length, simplifying questions, and allowing "free text" responses for all questions may optimize response rates.

Online patient safety education programme for junior doctors: is it worthwhile?

PubMed

McCarthy, S E; O'Boyle, C A; O'Shaughnessy, A; Walsh, G

2016-02-01

Increasing demand exists for blended approaches to the development of professionalism. Trainees of the Royal College of Physicians of Ireland participated in an online patient safety programme. Study aims were: (1) to determine whether the programme improved junior doctors' knowledge, attitudes and skills relating to error reporting, open communication and care for the second victim and (2) to establish whether the methodology facilitated participants' learning. 208 junior doctors who completed the programme completed a pre-online questionnaire. Measures were "patient safety knowledge and attitudes", "medical safety climate" and "experience of learning". Sixty-two completed the post-questionnaire, representing a 30 % matched response rate. Participating in the programme resulted in immediate (p < 0.01) improvement in skills such as knowing when and how to complete incident forms and disclosing errors to patients, in self-rated knowledge (p < 0.01) and attitudes towards error reporting (p < 0.01). Sixty-three per cent disagreed that doctors routinely report medical errors and 42 % disagreed that doctors routinely share information about medical errors and what caused them. Participants rated interactive features as the most positive elements of the programme. An online training programme on medical error improved self-rated knowledge, attitudes and skills in junior doctors and was deemed an effective learning tool. Perceptions of work issues such as a poor culture of error reporting among doctors may prevent improved attitudes being realised in practice. Online patient safety education has a role in practice-based initiatives aimed at developing professionalism and improving safety.

A faculty development course to enhance dental hygiene distance education: a pilot study.

PubMed

Johnstone-Dodge, Vicki; Bowen, Denise M; Calley, Kristin H; Peterson, Teri S

2014-09-01

This article describes the implementation and evaluation of a dental hygiene faculty development course to enhance online teaching practices that foster a sense of community and satisfaction. The sampled population was drawn from the forty-seven U.S. dental hygiene programs that the American Dental Hygienists' Association identified as offering bachelor's degree completion or master's degree programs with 76-100 percent of coursework delivered in an online format. This requirement was applied to exclude programs using hybrid instruction (combination of online and face-to-face). Of the thirty-four faculty members who self-identified as meeting the criteria, seven agreed to participate (21 percent response rate); however, only five completed all parts of the study (a final response rate of 15 percent). A Community of Inquiry framework was the basis for the author-designed Distance Education Best Practices Survey used as a pretest and posttest to assess participants' use of and perceived importance of twenty-five best practices before and after taking the online faculty development course. Frequency of use ratings ranged from 4.0 (regularly) to 5.0 (always) on a response scale from 1.0 to 5.0. The results showed significant increases from before to after the course in participants' perceptions of the importance of four practices: activities promoting relevant, lifelong learning (p=0.03); faculty communication fostering a sense of community (p=0.04); encouraging students' self-introduction (p=0.04); and encouraging productive dialogue and respecting diverse opinions (p=0.04). The findings indicate a potential value for a faculty development course designed to enhance online teaching, sense of community, and satisfaction, even for faculty members with high self-ratings regarding best practices.

Impact of Race, Ethnicity and BMI on Achievement of Pathologic Complete Response Following Neoadjuvant Chemotherapy for Breast Cancer: A Pooled Analysis of Four Prospective Alliance Clinical Trials (A151426)

PubMed Central

Warner, Erica T.; Ballman, Karla V.; Strand, Carrie; Boughey, Judy; Buzdar, Aman U.; Carey, Lisa A.; Sikov, William M.; Partridge, H.

2016-01-01

Purpose Previous studies demonstrated poor response to neoadjuvant systemic therapy (NST) for breast cancer among black women and women who are overweight or obese but this may be due to chemotherapy under dosing. We assessed associations of race, ethnicity and body mass index (BMI) with pathologic complete response (pCR) in clinical trial populations. Methods 1797 women enrolled in four NST trials (CALGB 40601, 40603; ACOSOG Z1041, Z1071) were included. Tumor subtypes were defined by estrogen receptor (ER) and HER2 status. Logistic regression generated odds ratios (OR) and 95% confidence intervals (CI) for the associations of race, ethnicity, and BMI with pCR adjusting for subtype, study arm, lymph node status, tumor size, and tumor grade. Results 253 (14.1%) were black, 199 (11.1%) Hispanic, 520 (28.9%) overweight, and 743 (41.4%) obese. Compared to whites, Blacks and Hispanics were more likely to be obese and Blacks were more likely to have triple-negative cancer. pCR rates differed significantly by tumor subtype. In multivariate analyses, neither race (black vs. white: OR: 1.18, 95% CI: 0.85–1.62) nor ethnicity (Hispanic vs. non-Hispanic: OR: 1.30, 95% CI: 0.67–2.53) were significant predictors of pCR overall or by subtype. Overweight and obese women had lower pCR rates in ER+/HER2+, but higher pCR rates in ER−/HER2+ cancers. Conclusions There was no difference in breast pCR according to race or ethnicity. Overall, there was no major difference in pCR rates by BMI. These findings suggest that pCR with optimally dosed NST is a function of tumor, rather than patient, biology. PMID:27449492

Impact of race, ethnicity, and BMI on achievement of pathologic complete response following neoadjuvant chemotherapy for breast cancer: a pooled analysis of four prospective Alliance clinical trials (A151426).

PubMed

Warner, Erica T; Ballman, Karla V; Strand, Carrie; Boughey, Judy C; Buzdar, Aman U; Carey, Lisa A; Sikov, William M; Partridge, Ann H

2016-08-01

Previous studies demonstrated poor response to neoadjuvant systemic therapy (NST) for breast cancer among black women and women who are overweight or obese, but this may be due to chemotherapy underdosing. We assessed associations of race, ethnicity, and body mass index (BMI) with pathologic complete response (pCR) in clinical trial populations. 1797 women enrolled in four NST trials (CALGB 40601, 40603; ACOSOG Z1041, Z1071) were included. Tumor subtypes were defined by estrogen receptor (ER) and HER2 status. Logistic regression generated odds ratios (OR) and 95 % confidence intervals (CI) for the associations of race, ethnicity, and BMI with in-breast pCR adjusting for subtype, study arm, lymph node status, tumor size, and tumor grade. 253 (14.1 %) were black, 199 (11.1 %) Hispanic, 520 (28.9 %) overweight, and 743 (41.4 %) obese. Compared to whites, Blacks and Hispanics were more likely to be obese and Blacks were more likely to have triple-negative cancer. pCR rates differed significantly by tumor subtype. In multivariate analyses, neither race (black vs white: OR 1.18, 95 % CI 0.85-1.62) nor ethnicity (Hispanic vs non-Hispanic; OR 1.30, 95 % CI 0.67-2.53) were significant predictors of pCR overall or by subtype. Overweight and obese women had lower pCR rates in ER+/HER2+, but higher pCR rates in ER-/HER2+ cancers. There was no difference in pCR according to race or ethnicity. Overall, there was no major difference in pCR rates by BMI. These findings suggest that pCR with optimally dosed NST is a function of tumor, rather than patient, biology.

[Feasibility and short-term efficacy of simplified intensity-modulated radiotherapy and concurrent chemotherapy for neck and upper thoracic esophageal carcinoma].

PubMed

Zhu, Wei-Guo; Yu, Chang-Hua; Han, Ji-Hua; Li, Tao; Zhou, Xi-Lei; Tao, Guang-Zhou

2009-12-01

For neck and upper thoracic esophageal carcinoma, three dimensional conformal radiation therapy (3D-CRT) does not necessarily meet all clinical requirements while intensity modulated radiation therapy (IMRT) may take up a lot of labour power and material resources. This study was to explore the feasibility of simplified IMPT(sIMRT) and concurrent chemotherapy for neck and upper thoracic esophageal carcinoma, and to investigate the acute toxicities and short-term efficacy of this treatment modality. sIMRT plans were designed for 30 patients with neck and upper thoracic esophageal carcinoma. Two target volumes were defined: PTV1, which was designed to irradiate to 64 Gy (2.13 Gy x 30 fractions); PTV2, which was given to 54 Gy (1.8 Gy x 30). The sIMRT plan included five equiangular coplanar beams. All patients concurrently received DDP+5-FU regimen with radiotherapy on d1-5 and d29-33. Chemotherapy was repeated for two cycles 28 days after radiotherapy. The treatment was completed for all patients within 6 weeks, and only one patient had Grade 3 acute bronchitis. The complete response (CR) rate was 90.0% (27/30) and the partial response (PR) rate 10.0% (3/30). Overall response was 100% for esophageal lesions and the CR rate 76.5% (13/17). The PR rate was 23.5% (4/17) in lymph node lesions. The major toxicities observed were Grades I-II leukocytopenia. sIMRT can generate desirable dose distribution for neck and upper thoracic esophageal carcinoma, which is similar to sophisticated IMRT but obviously better than 3D-CRT. The short-term efficacy of sIMRT is satisfactory and its acute toxicities are tolerable.

Facilitating comparative effectiveness research in cancer genomics: evaluating stakeholder perceptions of the engagement process

PubMed Central

Deverka, Patricia A; Lavallee, Danielle C; Desai, Priyanka J; Armstrong, Joanne; Gorman, Mark; Hole-Curry, Leah; O’Leary, James; Ruffner, BW; Watkins, John; Veenstra, David L; Baker, Laurence H; Unger, Joseph M; Ramsey, Scott D

2013-01-01

Aims The Center for Comparative Effectiveness Research in Cancer Genomics completed a 2-year stakeholder-guided process for the prioritization of genomic tests for comparative effectiveness research studies. We sought to evaluate the effectiveness of engagement procedures in achieving project goals and to identify opportunities for future improvements. Materials & methods The evaluation included an online questionnaire, one-on-one telephone interviews and facilitated discussion. Responses to the online questionnaire were tabulated for descriptive purposes, while transcripts from key informant interviews were analyzed using a directed content analysis approach. Results A total of 11 out of 13 stakeholders completed both the online questionnaire and interview process, while nine participated in the facilitated discussion. Eighty-nine percent of questionnaire items received overall ratings of agree or strongly agree; 11% of responses were rated as neutral with the exception of a single rating of disagreement with an item regarding the clarity of how stakeholder input was incorporated into project decisions. Recommendations for future improvement included developing standard recruitment practices, role descriptions and processes for improved communication with clinical and comparative effectiveness research investigators. Conclusions Evaluation of the stakeholder engagement process provided constructive feedback for future improvements and should be routinely conducted to ensure maximal effectiveness of stakeholder involvement. PMID:23459832

Phase I/II Clinical Trial of Hyaluronan-Cisplatin Nanoconjugate for the Treatment of Spontaneous Canine Cancers

PubMed Central

Cai, Shuang; Zhang, Ti; Forrest, W.C.; Yang, Qiuhong; Groer, Chad; Mohr, Eva; Aires, Daniel J.; Axiak-Bechtel, Sandra M.; Flesner, Brian K.; Henry, Carolyn J.; Selting, Kimberly A.; Tate, Deborah; Swarz, Jeffrey A.; Bryan, Jeffrey N.; Forrest, M. Laird

2015-01-01

Objective To conduct an open label, multi-dose Phase I/II clinical study in spontaneous canine cancers and evaluate the pharmacokinetics, safety, and efficacy of the hyaluronan-based cisplatin formulation (HA-Pt). Animals 13 dogs with heterogeneous, naturally occurring cancers. Procedures The dogs received up to four injections of 10-30 mg/m2 HA-Pt into the tumor or peritumoral sub-mucosa at three-week intervals. Blood sample (2 mL) was collected from the jugular catheter at 0.5, 1, 2, 4, and 24 hours following drug administration. A complete blood count and renal profile with urinalysis were conducted prior to and one week after each treatment. Tumor measurements were collected three weeks following each administration to assess response. Results Of the 13 dogs with heterogeneous, naturally occurring cancers, 23% had complete response and 15% had partial response or stable disease. Among the dogs that received drug with low diaquated content, the complete response rate for SCC was 3/7 (43%). Myelosuppression and cardiac toxicity were observed for 38% and 19% of the dogs, respectively. The formulation did not cause nephrotoxicity, the dose-limiting toxicity of standard cisplatin, in any dogs. Conclusions and Clinical Relevance The HA-Pt formulation demonstrated positive response in spontaneous canine squamous cell carcinomas. It did not cause nephrotoxicity in any patients. Canine oral SCC is very homogenous in progression and drug response to human HNSCC, and these results could be useful in developing human treatments. PMID:27580113

RESPONSIVENESS OF THE ACTIVITIES OF DAILY LIVING SCALE OF THE KNEE OUTCOME SURVEY AND NUMERIC PAIN RATING SCALE IN PATIENTS WITH PATELLOFEMORAL PAIN

PubMed Central

Piva, Sara R.; Gil, Alexandra B.; Moore, Charity G.; Fitzgerald, G. Kelley

2016-01-01

Objective To assess internal and external responsiveness of the Activity of Daily Living Scale of the Knee Outcome Survey and Numeric Pain Rating Scale on patients with patellofemoral pain. Design One group pre-post design. Subjects A total of 60 individuals with patellofemoral pain (33 women; mean age 29.9 (standard deviation 9.6) years). Methods The Activity of Daily Living Scale and the Numeric Pain Rating Scale were assessed before and after 8 weeks of physical therapy program. Patients completed a global rating of change scale at the end of therapy. The standardized effect size, Guyatt responsiveness index, and the minimum clinical important difference were calculated. Results Standardized effect size of the Activity of Daily Living Scale was 0.63, Guyatt responsiveness index was 1.4, area under the curve was 0.83 (95% confidence interval: 0.72, 0.94), and the minimum clinical important difference corresponded to an increase of 7.1 percentile points. Standardized effect size of the Numeric Pain Rating Scale was 0.72, Guyatt responsiveness index was 2.2, area under the curve was 0.80 (95% confidence interval: 0.70, 0.92), and the minimum clinical important difference corresponded to a decrease of 1.16 points. Conclusion Information from this study may be helpful to therapists when evaluating the effectiveness of rehabilitation intervention on physical function and pain, and to power future clinical trials on patients with patellofemoral pain. PMID:19229444

Responsiveness of the activities of daily living scale of the knee outcome survey and numeric pain rating scale in patients with patellofemoral pain.

PubMed

Piva, Sara R; Gil, Alexandra B; Moore, Charity G; Fitzgerald, G Kelley

2009-02-01

To assess internal and external responsiveness of the Activity of Daily Living Scale of the Knee Outcome Survey and Numeric Pain Rating Scale on patients with patellofemoral pain. One group pre-post design. A total of 60 individuals with patellofemoral pain (33 women; mean age 29.9 (standard deviation 9.6) years). The Activity of Daily Living Scale and the Numeric Pain Rating Scale were assessed before and after 8 weeks of physical therapy program. Patients completed a global rating of change scale at the end of therapy. The standardized effect size, Guyatt responsiveness index, and the minimum clinical important difference were calculated. Standardized effect size of the Activity of Daily Living Scale was 0.63, Guyatt responsiveness index was 1.4, area under the curve was 0.83 (95% confidence interval: 0.72, 0.94), and the minimum clinical important difference corresponded to an increase of 7.1 percentile points. Standardized effect size of the Numeric Pain Rating Scale was 0.72, Guyatt responsiveness index was 2.2, area under the curve was 0.80 (95% confidence interval: 0.70, 0.92), and the minimum clinical important difference corresponded to a decrease of 1.16 points. Information from this study may be helpful to therapists when evaluating the effectiveness of rehabilitation intervention on physical function and pain, and to power future clinical trials on patients with patellofemoral pain.

Sexual dimorphism in the osmopressor response following water ingestion

PubMed Central

Mendonca, Goncalo V.; Teodósio, Carolina; Lucena, Rui; Pereira, Fernando D.

2016-01-01

There is conflicting evidence as to whether water drinking elicits a pressor response in healthy young adults. The inclusion of a variable number of women may have contributed to the discrepancies found in past research. Thus, we aimed at exploring whether the osmopressor response follows a sexually dimorphic pattern. In a randomized fashion, 31 healthy adults (16 men; 15 women, aged 18–40 years) ingested 50 and 500 ml of water before completing a resting protocol on two separate days. Arterial blood pressure, heart rate and spectral heart rate variability were measured in the seated position at pre- and post-25 min of water ingestion. Women responded to 500 ml of water with a greater proportion of change in diastolic and mean arterial pressure (MAP) (P<0.05). Conversely, the percent change in systolic blood pressure (SBP) and heart rate was not different between sexes after 500 ml of water. Overall, women demonstrated lower blood pressure, but higher resting heart rate compared with men (P<0.05). In contrast, heart rate variability was similar between sexes before and after ingesting either volume of water. There was a bradycardic effect of water and, irrespectively of sex; this was accompanied by increased high frequency power (HF) (P<0.05). We conclude that women display a greater magnitude of pressor response than men post-water ingestion. Accordingly, we provide direct evidence of sexual dimorphism in the haemodynamic response to water intake in young healthy adults. PMID:27129286

Palliative Short-Course Radiation Therapy in Rectal Cancer: A Phase 2 Study

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

Picardi, Vincenzo; Deodato, Francesco; Guido, Alessandra

2016-07-15

Purpose: The management of patients with symptomatic rectal cancer not amenable to curative treatment may be challenging. The aim of this phase 2 study was to evaluate the efficacy of short-course radiation therapy in patients with obstructing rectal cancer. Methods and Materials: Patients who were not candidates for surgical resection because of synchronous metastases, age, and/or comorbidities were considered eligible. The sample size was calculated based on the 2-stage design of Simon. Short-course radiation therapy was delivered with an isocentric 4-field box technique (total, 25 Gy; 5 fractions in 5 days). Chemotherapy was suspended during radiation treatment. Clinical outcome measures were symptomaticmore » response rate, toxicity, colostomy-free survival, and overall survival. Results: From October 2003 to November 2012, 18 patients (median age, 77.5 years) were enrolled. The median follow-up was 11.5 months (range, 3-36 months). Four weeks after treatment, a complete response (ie, complete symptom resolution) was observed in 38.9% of patients and a partial response in 50.0% cases, whereas 11.1% had no response. The rates of reduction or resolution of pain and bleeding were 87.5% and 100%, respectively. The 1-, 2-, and 3-year colostomy-free survival rates were 100%, 71.4%, and 47.6%, respectively (median, 30 months). The 1-, 2-, and 3-year cumulative overall survival rates were 85.2%, 53%, and 39.8%, respectively (median, 25 months). No patients stopped treatment because of gastrointestinal or genitourinary toxicities: 38.9% of patients had grade 1 to 2 toxicity, and 16.7% had grade 3 toxicity. Only 1 patient had hematologic grade 2 toxicity, and 2 patients had grade 2 skin toxicity. Conclusions: Short-course radiation therapy may represent a safe and effective alternative treatment option in patients with obstructing rectal cancer not eligible for curative treatment, allowing colostomy to be avoided in a substantial proportion of patients.« less

A phase II Study Evaluating Combined Neoadjuvant Cetuximab and Chemotherapy Followed by Chemoradiotherapy and Concomitant Cetuximab in Locoregional Oesophageal Cancer Patients.

PubMed

Alsina, Maria; Rivera, Fernando; Ramos, Francisco Javier; Galán, Maica; López, Rafael; García-Alfonso, Pilar; Alés-Martinez, José Enrique; Queralt, Bernardo; Antón, Antonio; Carrato, Alfredo; Grávalos, Cristina; Méndez-Vidal, Maria José; López, Carlos; de Mena, Inmaculada Ruiz; Tabernero, Josep; Giralt, Jordi; Aranda, Enrique

2018-02-01

Pre-operative chemoradiotherapy using a 5-fluorouracil (5-FU)/cisplatin backbone is widely used to improve surgical outcomes in locoregional oesophageal cancer patients, despite a non-negligible failure rate. We evaluated intensification of this approach to improve patient outcomes by adding cetuximab to induction 5-FU/cisplatin/docetaxel (TPF) and to chemoradiotherapy in a phase II study. Between November 2006 and April 2009, 50 patients with stage II-IVa squamous cell carcinoma (SCC) or adenocarcinoma of the oesophagus or gastro-oesophageal junction initiated three TPF/cetuximab cycles. Six weeks later, patients with response or stabilisation initiated 6 weeks of cisplatin/cetuximab/radiotherapy, followed by surgery. The primary objective was the clinical complete response (cCR) rate after induction therapy plus chemoradiotherapy in intent-to-treat patients. Thirty-eight patients were evaluable after chemoradiotherapy, 84% of whom showed disease control. Six patients (12%) achieved a cCR, with a 54% overall response rate. Twenty-seven patients underwent surgery, 11 of whom (22%; nine SCC, two adenocarcinoma) had a pathological CR (41%). Fifteen patients were alive after a median follow-up of 23.2 months. Median progression-free survival was 12.2 months (95% confidence interval [CI] 1.7-22.8). Median overall survival was 23.4 months (95% CI 12.2-36.6) and was significantly longer among the 22 patients with complete resection than in the five patients without (42.1 vs. 24.9 months; p = 0.02, hazard ratio: 3.6, 95% CI 1.1-11.6). The toxicity profile was acceptable. Neoadjuvant cetuximab/TPF followed by chemoradiotherapy in locoregional oesophageal carcinoma patients is feasible and offers a modest response rate in this trial. The results of combining trimodality neoadjuvant treatment with cetuximab are consistent with the literature. Registration: The study is registered at ClinicalTrials.gov (NCT00733889).

The Outpatient Experience Questionnaire of comprehensive public hospital in China: development, validity and reliability.

PubMed

Hu, Yinhuan; Zhang, Zixia; Xie, Jinzhu; Wang, Guanping

2017-02-01

The objective of this study is to describe the development of the Outpatient Experience Questionnaire (OPEQ) and to assess the validity and reliability of the scale. Literature review, patient interviews, Delphi method and Cross-sectional validation survey. Six comprehensive public hospitals in China. The survey was carried out on a sample of 600 outpatients. Acceptability of the questionnaire was assessed according to the overall response rate, item non-response rate and the average completion time. Correlation coefficients and confirmatory factor analysis were used to test construct validity. Delphi method was used to assess the content validity of the questionnaire. Cronbach's coefficient alpha and split-half reliability coefficient were used to estimate the internal reliability of the questionnaire. The overall response rate was 97.2% and the item non-response rate ranged from 0% to 0.3%. The mean completion time was 6 min. The Spearman correlations of item-total score ranged from 0.466 to 0.765. The results of confirmatory factor analysis showed that all items had factor loadings above 0.40 and the dimension intercorrelation ranged from 0.449 to 0.773, the goodness of fit of the questionnaire was reasonable. The overall authority grade of expert consultation was 0.80 and Kendall's coefficient of concordance W was 0.186. The Cronbach's coefficients alpha of six dimensions ranged from 0.708 to 0.895, the split-half reliability coefficient (Spearman-Brown coefficient) was 0.969. The OPEQ is a promising instrument covering the most important aspects which influence outpatient experiences of comprehensive public hospital in China. It has good evidence for acceptability, validity and reliability. © The Author 2016. Published by Oxford University Press in association with the International Society for Quality in Health Care. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com

Individual payments as a longer-term incentive in online panels.

PubMed

Göritz, Anja S; Wolff, Hans-Georg; Goldstein, Daniel G

2008-11-01

Does it pay to pay online panel members? A three-wave longitudinal experiment was conducted with an online panel to examine whether per person payments, paid through an online intermediary, influence response and retention rates. In the payment condition, participants were promised payment for participation at each wave, whereas control participants were not offered any payment. The promise of a payment had a negative effect on response in Wave 1, but a positive effect on response in Wave 2. Payment had no significant effect on retention. Completing a given wave was an indicator for responding to a subsequent invitation.

Computerized Cognitive Training in Children With Autism and Intellectual Disabilities: Feasibility and Satisfaction Study

PubMed Central

Benyakorn, Songpoom; Calub, Catrina A; Riley, Steven J; Schneider, Andrea; Iosif, Ana-Maria; Solomon, Marjorie; Hessl, David

2018-01-01

Background Researchers are increasingly interested in testing and developing computerized cognitive training interventions for individuals with autism spectrum disorder due to the limited accessibility of treatments for this disorder. Understanding the feasibility of testing cognitive interventions for this population is critical, especially for individuals with ASD who have low to moderate intellectual ability. Objective The aim of the study was to evaluate the feasibility of computerized cognitive training as measured by attrition rate and a parent satisfaction survey. Methods A total of 26 participants aged 8-17 years with an autism spectrum disorder diagnosis and significant intellectual impairment were enrolled (mean age 11.1 years). They were instructed to complete 25 sessions of Cogmed Working Memory Training in 5 to 6 weeks with coach assistance. Attrition rate and parent satisfaction surveys were measured after the completion of training. Results Most participants (96%, 25/26) completed the training and indicated high satisfaction (>88%). However, among the participants who completed the training, 5 participants (19%) were unable to finish in 6 weeks, the recommended training period by Cogmed. Parents noted various positive (eg, voice-overs) and negative (eg, particular graphic and sounds associated with a stimulus) features of the game that they thought affected their child’s response. Conclusions Children with autism spectrum disorder and intellectual impairments can successfully participate in computerized cognitive training interventions but may require additional weeks to complete the training beyond the time needed for children without intellectual impairments. The overall completion rate, with extended time to complete the training, was high. Developers of cognitive training programs for this population should take into account potential issues regarding the noise level of stimuli and characteristics of the visual graphics. PMID:29802090

A Double-Blind Randomized Controlled Trial of Ethyl-Eicosapentaenoate (EPA-E) for Major Depressive Disorder

PubMed Central

Mischoulon, David; Papakostas, George I.; Dording, Christina M.; Farabaugh, Amy H.; Sonawalla, Shamsah B.; Agoston, Monica; Smith, Juliana; Beaumont, Erin; Dahan, Liat; Alpert, Jonathan E.; Nierenberg, Andrew A.; Fava, Maurizio

2010-01-01

Objective We examined the efficacy and tolerability of ethyl-eicosapentaenoate (EPA-E) monotherapy for major depressive disorder (MDD) in a double-blind, randomized controlled pilot study. Methods 57 adults with DSM-IV MDD were randomized from 1/2003-6/2006 to receive 1 gram/day of EPA or placebo (PBO) for 8 weeks. Response criteria were based on the Hamilton-D-17 scale. Subjects' plasma lipid profiles were examined by gas chromatography. Results 35 subjects (63% female; mean age 45+/-13 yrs) were eligible for the intent to treat (ITT) analysis. In the ITT sample, mean HAM-D-17 scores decreased from 21.6+/-2.7 to 13.9+/-8.9 for the EPA group (n=16) and from 20.5+/-3.6 to 17.5+/-7.5 for the PBO group (n=19) (p=0.123); the effect size for EPA was 0.55. ITT response rates were 38% (6/16) for EPA, and 21% (4/19) for PBO (p=0.45). Among the 24 study completers, mean HAM-D-17 scores decreased from 21.3+/-3.0 to 11.1+/-8.1 for the EPA group and from 20.5+/-3.8 to 16.3+/-6.9 for the PBO group (p=0.087); the effect size for EPA was 0.73. Completer response rates were 45% (5/11) for EPA, and 23% (3/13) for PBO (p=0.39). Among EPA subjects, baseline n-6/n-3 ratio was associated with decrease in HAM-D-17 score (r= -0.686, p=0.030) and with treatment response (p=0.032); change in n-6/n-3 ratio was associated with change in HAM-D-17 score (r=0.784, p=0.032). Side effects, reported in 2 EPA subjects and 5 PBO subjects, were exclusively gastrointestinal, mild, and not associated with discontinuation. Conclusions EPA demonstrated an advantage over placebo that did not reach statistical significance, possibly due to the small sample and low completer rates, which were the major study limitations. PMID:19709502

Some effects of stress on users of a voice recognition system: A preliminary inquiry

NASA Astrophysics Data System (ADS)

French, B. A.

1983-03-01

Recent work with Automatic Speech Recognition has focused on applications and productivity considerations in the man-machine interface. This thesis is an attempt to see if placing users of such equipment under time-induced stress has an effect on their percent correct recognition rates. Subjects were given a message-handling task of fixed length and allowed progressively shorter times to attempt to complete it. Questionnaire responses indicate stress levels increased with decreased time-allowance; recognition rates decreased as time was reduced.

Second-line chemotherapy of disseminated malignant melanoma with cystemustine at 60 mg/m2: a phase II trial.

PubMed

Thivat, Emilie; Durando, Xavier; D'Incan, Michel; Cure, Hervé; Mouret-Reynier, Marie-Ange; Madelmont, Jean-Claude; Souteyrand, Pierre; Chollet, Philippe

2005-10-01

Nitrosoureas possess some anti-tumor activity as a single agent in metastatic melanoma (MM). In a phase II trial, we evaluated the anti-tumor effects of cystemustine chemotherapy, a new nitrosourea, as a second-line treatment. Patients were required to have histologic evidence of disseminated MM and had failed in first-line chemotherapy. Treatment comprised cystemustine given at a dose of 60 mg/m every 2 weeks by a 15-min infusion. From February 1997 to September 1999, 22 patients (median age 66 years) were enrolled and were assessable. Two complete responses, one partial response, three stable diseases and 16 progressions were observed, giving an overall response rate of 13.6%. Median duration of response was 10 months (range 4-63). Median survival of responders and non-responders was 11 and 4 months, respectively. However, hematological toxicity, particularly thrombopenia, was a limiting factor for one-third of patients. We conclude that cystemustine at 60 mg/m is active in patients who progressed after one line of chemotherapy in advanced disease, and offers the possibility of complete responses and long durations of these responses.

Prevalence and Predictors of Burnout Among Hospice and Palliative Care Clinicians in the U.S.

PubMed

Kamal, Arif H; Bull, Janet H; Wolf, Steven P; Swetz, Keith M; Shanafelt, Tait D; Ast, Katherine; Kavalieratos, Dio; Sinclair, Christian T; Abernethy, Amy P

2016-04-01

Many clinical disciplines report high rates of burnout, which lead to low quality of care. Palliative care clinicians routinely manage patients with significant suffering, aiming to improve quality of life. As a major role of palliative care clinicians involves educating patients and caregivers regarding identifying priorities and balancing stress, we wondered how clinician self-management of burnout matches against the emotionally exhaustive nature of the work. We sought to understand the prevalence and predictors of burnout using a discipline-wide survey. We asked American Academy of Hospice and Palliative Medicine clinician members to complete an electronic survey querying demographic factors, job responsibilities, and the Maslach Burnout Inventory. We performed univariate and multivariate regression analyses to identify predictors of high rates of burnout. We received 1357 responses (response rate 30%). Overall, we observed a burnout rate of 62%, with higher rates reported by nonphysician clinicians. Most burnout stemmed from emotional exhaustion, with depersonalization comprising a minor portion. Factors associated with higher rates of burnout include working in smaller organizations, working longer hours, being younger than 50 years, and working weekends. We did not observe different rates between palliative care clinicians and hospice clinicians. Higher rated self-management activities to mitigate burnout include participating in interpersonal relationships and taking vacations. Burnout is a major issue facing the palliative care clinician workforce. Strategies at the discipline-wide and individual levels are needed to sustain the delivery of responsive, available, high-quality palliative care for all patients with serious illness. Copyright © 2016 American Academy of Hospice and Palliative Medicine. Published by Elsevier Inc. All rights reserved.

Prevalence and Predictors of Burnout Among Hospice and Palliative Care Clinicians in the U.S

PubMed Central

Kamal, Arif H.; Bull, Janet H.; Wolf, Steven P.; Swetz, Keith M.; Shanafelt, Tait D.; Ast, Katherine; Kavalieratos, Dio; Sinclair, Christian T.; Abernethy, Amy P.

2016-01-01

Context Many clinical disciplines report high rates of burnout, which lead to low quality of care. Palliative care clinicians routinely manage patients with significant suffering, aiming to improve quality of life. As a major role of palliative care clinicians involves educating patients and caregivers regarding identifying priorities and balancing stress, we wondered how clinician self-management of burnout matches against the emotionally exhaustive nature of the work. Objectives We sought to understand the prevalence and predictors of burnout using a discipline-wide survey. Methods We asked American Academy of Hospice and Palliative Medicine clinician members to complete an electronic survey querying demographic factors, job responsibilities, and the Maslach Burnout Inventory. We performed univariate and multivariate regression analyses to identify predictors of high rates of burnout. Results We received 1357 responses (response rate 30%). Overall, we observed a burnout rate of 62%, with higher rates reported by nonphysician clinicians. Most burnout stemmed from emotional exhaustion, with depersonalization comprising a minor portion. Factors associated with higher rates of burnout include working in smaller organizations, working longer hours, being younger than 50 years, and working weekends. We did not observe different rates between palliative care clinicians and hospice clinicians. Higher rated self-management activities to mitigate burnout include participating in interpersonal relationships and taking vacations. Conclusions Burnout is a major issue facing the palliative care clinician workforce. Strategies at the discipline-wide and individual levels are needed to sustain the delivery of responsive, available, high-quality palliative care for all patients with serious illness. PMID:26620234

The modulatory effects of noradrenaline on vagal control of heart rate in the dogfish, Squalus acanthias.

PubMed

Agnisola, Claudio; Randall, David J; Taylor, Edwin W

2003-01-01

The possible interactions between inhibitory vagal control of the heart and circulating levels of catecholamines in dogfish (Squalus acanthias) were studied using an in situ preparation of the heart, which retained intact its innervation from centrally cut vagus nerves. The response to peripheral vagal stimulation typically consisted of an initial cardiac arrest, followed by an escape beat, leading to renewed beating at a mean heart rate lower than the prestimulation rate (partial recovery). Cessation of vagal stimulation led to a transient increase in heart rate, above the prestimulation rate. This whole response was completely abolished by 10(-4) M atropine (a muscarinic cholinergic antagonist). The degree of vagal inhibition was evaluated in terms of both the initial, maximal cardiac interval and the mean heart rate during partial recovery, both expressed as a percentage of the prestimulation heart rate. The mean prestimulation heart rate of this preparation (36+/-4 beats min(-1)) was not affected by noradrenaline but was significantly reduced by 10(-4) M nadolol (a beta-adrenergic receptor antagonist), suggesting the existence of a resting adrenergic tone arising from endogenous catecholamines. The degree of vagal inhibition of heart rate varied with the rate of stimulation and was increased by the presence of 10(-8) M noradrenaline (the normal in vivo level in routinely active fish), while 10(-7) M noradrenaline (the in vivo level measured in disturbed or deeply hypoxic fish) reduced the cardiac response to vagal stimulation. In the presence of 10(-7) M noradrenaline, 10(-4) M nadolol further reduced the vagal response, while 10(-4) M nadolol + 10(-4) M phentolamine had no effect, indicating a complex interaction between adrenoreceptors, possibly involving presynaptic modulation of vagal inhibition.

Dental Student, Resident, and Faculty Attitudes Toward Treating Medicaid Patients.

PubMed

Behar-Horenstein, Linda S; Feng, Xiaoying

2017-11-01

Failure to receive proper oral health care including both prevention and maintenance is influenced by myriad and complex social, economic, and dental factors, including access to care. Reducing oral health disparities requires changes in the preparation of future dentists as well as measuring and influencing the attitudes and knowledge of practicing dentists. The aim of this study was to determine the likelihood that future dentists (students and residents) and faculty members at one U.S. dental school would treat Medicaid participants. Attitudes were measured using the Deamonte Driver scenario survey, which assesses factors affecting dentists' participation in Medicaid. In October 2012, all 113 full-time faculty members were invited to participate, and 60 completed the survey, for a response rate of 53.1%. In January and February 2013, all 18 residents in the dental clinics and university hospital were invited to participate, and 16 completed the survey, for a response rate of 88.9%. From 2013 to 2015, all 267 students in three classes were invited to participate: first-year students in the Classes of 2017 and 2018 and fourth-year students in the Class of 2015. A total of 255 students completed the survey, for an overall student response rate of 95.5%. The results showed that the students were more likely to participate in caring for Medicaid patients than the faculty and residents. The white and male students had stronger negative stereotypes about Medicaid patients than the females and underrepresented minority students, while residents had stronger negative stereotypes about Medicaid patients than the students and faculty. Overall, the cultural competency skills, beliefs, and attitudes of these faculty members and residents were less developed than those of their students, signaling a need for broad educational and faculty development programs to fully prepare the future dental workforce to care for these patients.

Impact of supervised student optometry consultations on the patient experience.

PubMed

Bentley, Sharon A; Trevaskis, Jane E; Woods, Craig A; Guest, Daryl; Watt, Kathleen G

2018-03-01

Understanding patient perceptions of having students involved in their clinical care is important as we strive to develop optimal models of care that integrate teaching with the best possible experience for the patient. The aim was to ascertain the impact of supervised optometry student consultations on the patient experience. A survey comprising 45 questions was mailed to consecutive adult patients who had undergone a comprehensive eye examination at the Australian College of Optometry over a four-week period. Responses were received from 193 patients who had a student involved in their care (44 per cent response rate; 156 completed correctly) and 177 who did not have a student involved (32 per cent response rate; 105 completed correctly). There was no significant difference in overall patient satisfaction between the teaching and non-teaching clinics (p = 0.18). Over 87 per cent of patients in the teaching clinic felt completely comfortable with a student examining them, 44 per cent felt their care was better because a student was involved and 97 per cent rated the overall performance of the student as very good or good. Although 12 per cent would rather have seen only the optometrist and three per cent would not be happy to have a student involved in their eye care again, 100 per cent believed it is important for students to work with patients. The most common reason for student acceptance was the importance of students needing opportunities to learn. The main reasons for unwillingness to have a student involved in future were the additional time taken and prolonged testing. The findings of this study suggest that most patients view supervised student involvement in their optometric care as an important and highly positive experience. However, efforts should be made to avoid excessively long consultations and prolonged testing. Concerns about patient satisfaction and acceptance are largely unwarranted and should not prevent optometry students being involved in patient care. © 2017 Optometry Australia.

A trial of e-simulation of sudden patient deterioration (FIRST2ACT WEB) on student learning.

PubMed

Bogossian, Fiona E; Cooper, Simon J; Cant, Robyn; Porter, Joanne; Forbes, Helen

2015-10-01

High-fidelity simulation pedagogy is of increasing importance in health professional education; however, face-to-face simulation programs are resource intensive and impractical to implement across large numbers of students. To investigate undergraduate nursing students' theoretical and applied learning in response to the e-simulation program-FIRST2ACT WEBTM, and explore predictors of virtual clinical performance. Multi-center trial of FIRST2ACT WEBTM accessible to students in five Australian universities and colleges, across 8 campuses. A population of 489 final-year nursing students in programs of study leading to license to practice. Participants proceeded through three phases: (i) pre-simulation-briefing and assessment of clinical knowledge and experience; (ii) e-simulation-three interactive e-simulation clinical scenarios which included video recordings of patients with deteriorating conditions, interactive clinical tasks, pop up responses to tasks, and timed performance; and (iii) post-simulation feedback and evaluation. Descriptive statistics were followed by bivariate analysis to detect any associations, which were further tested using standard regression analysis. Of 409 students who commenced the program (83% response rate), 367 undergraduate nursing students completed the web-based program in its entirety, yielding a completion rate of 89.7%; 38.1% of students achieved passing clinical performance across three scenarios, and the proportion achieving passing clinical knowledge increased from 78.15% pre-simulation to 91.6% post-simulation. Knowledge was the main independent predictor of clinical performance in responding to a virtual deteriorating patient R(2)=0.090, F(7, 352)=4.962, p<0.001. The use of web-based technology allows simulation activities to be accessible to a large number of participants and completion rates indicate that 'Net Generation' nursing students were highly engaged with this mode of learning. The web-based e-simulation program FIRST2ACTTM effectively enhanced knowledge, virtual clinical performance, and self-assessed knowledge, skills, confidence, and competence in final-year nursing students. Copyright © 2015 Elsevier Ltd. All rights reserved.

Condition Self-Management in Pediatric Spina Bifida: A Longitudinal Investigation of Medical Adherence, Responsibility-Sharing, and Independence Skills.

PubMed

Psihogios, Alexandra M; Kolbuck, Victoria; Holmbeck, Grayson N

2015-09-01

This study aimed to evaluate rates of medical adherence, responsibility, and independence skills across late childhood and adolescence in youth with spina bifida (SB) and to explore associations among these disease self-management variables. 111 youth with SB, their parents, and a health professional participated at two time points. Informants completed questionnaires regarding medical adherence, responsibility-sharing, and child independence skills. Youth gained more responsibility and independence skills across time, although adherence rates did not follow a similar trajectory. Increased child medical responsibility was related to poorer adherence, and father-reported independence skills were associated with increased child responsibility. This study highlights medical domains that are the most difficult for families to manage (e.g., skin checks). Although youth appear to gain more autonomy across time, ongoing parental involvement in medical care may be necessary to achieve optimal adherence across adolescence. © The Author 2015. Published by Oxford University Press on behalf of the Society of Pediatric Psychology. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

Efficacy of single-agent bortezomib vs. single-agent thalidomide in patients with relapsed or refractory multiple myeloma: a systematic comparison

PubMed Central

Prince, H Miles; Adena, Michael; Smith, Dell Kingsford; Hertel, Judy

2007-01-01

Objective: To conduct a systematic review of the efficacy of single-agent bortezomib vs. single-agent thalidomide in patients with relapsed/refractory multiple. Methods: Publications in English from 1966 to June 2005 (MEDLINE, EMBASE, Cochrane library), publication reference lists, Janssen-Cilag data-on-file and abstracts from recent multiple myeloma conferences were reviewed. Prospective studies containing at least a single arm of either treatment group with n ≥ 30 were included. Studies adding dexamethasone for non-responders were excluded. Statistical pooling was performed for response rate and overall survival. Results: One bortezomib study (n = 333, NEJM 2005, 352; 2487–98) and 15 thalidomide (n = 1007) studies met these criteria and were included. Patient baseline characteristics including age, gender, IgG:IgA, disease duration and beta-2 microglobulin were well matched except that 48% of bortezomib patients had received prior thalidomide. Response rate, defined as serum M-protein reduction ≥ 50%, was 53% for patients receiving bortezomib vs. 32% for thalidomide (P < 0.001, n = 10 studies). Response rate determined by European Group for Blood and Marrow Transplantation (EBMT) criteria was 41% for patients receiving bortezomib vs. 22% for thalidomide (P < 0.001, n = 4 studies). Conclusion: Bortezomib was associated with a significantly higher response rate and complete remission rate using both M-protein and EBMT criteria. PMID:17608711

Rituximab after Autologous Stem-Cell Transplantation in Mantle-Cell Lymphoma.

PubMed

Le Gouill, Steven; Thieblemont, Catherine; Oberic, Lucie; Moreau, Anne; Bouabdallah, Krimo; Dartigeas, Caroline; Damaj, Gandhi; Gastinne, Thomas; Ribrag, Vincent; Feugier, Pierre; Casasnovas, Olivier; Zerazhi, Hacène; Haioun, Corinne; Maisonneuve, Hervé; Houot, Roch; Jardin, Fabrice; Van Den Neste, Eric; Tournilhac, Olivier; Le Dû, Katell; Morschhauser, Franck; Cartron, Guillaume; Fornecker, Luc-Matthieu; Canioni, Danielle; Callanan, Mary; Béné, Marie C; Salles, Gilles; Tilly, Hervé; Lamy, Thierry; Gressin, Remy; Hermine, Olivier

2017-09-28

Mantle-cell lymphoma is generally incurable. Despite high rates of complete response after initial immunochemotherapy followed by autologous stem-cell transplantation, patients have relapses. We investigated whether rituximab maintenance therapy at a dose of 375 mg per square meter of body-surface area administered every 2 months for 3 years after transplantation would prolong the duration of response. In a phase 3 trial involving 299 patients who were younger than 66 years of age at diagnosis, we randomly assigned 240 patients to receive rituximab maintenance therapy or to undergo observation after autologous stem-cell transplantation (120 patients per group); 59 patients did not undergo randomization. The primary end point was event-free survival (with an event defined as disease progression, relapse, death, allergy to rituximab, or severe infection) after transplantation among patients who underwent randomization. After four courses of immunochemotherapy induction (rituximab, dexamethasone, cytarabine, and a platinum derivative [R-DHAP]), the overall response rate was 89%, and the complete response rate 77%. Transplantation was performed in 257 patients. The median follow-up from randomization after transplantation was 50.2 months (range, 46.4 to 54.2). Starting from randomization, the rate of event-free survival at 4 years was 79% (95% confidence interval [CI], 70 to 86) in the rituximab group versus 61% (95% CI, 51 to 70) in the observation group (P=0.001). The rate of progression-free survival at 4 years was 83% (95% CI, 73 to 88) in the rituximab group versus 64% (95% CI, 55 to 73) in the observation group (P<0.001). The rate of overall survival was 89% (95% CI, 81 to 94) in the rituximab group versus 80% (95% CI, 72 to 88) in the observation group (P=0.04). According to a Cox regression unadjusted analysis, the rate of overall survival at 4 years was higher in the rituximab group than in the observation group (hazard ratio for death, 0.50; 95% CI, 0.26 to 0.99; P=0.04). Rituximab maintenance therapy after transplantation prolonged event-free survival, progression-free survival, and overall survival among patients with mantle-cell lymphoma who were younger than 66 years of age at diagnosis. (Funded by Roche and Amgen; LyMa ClinicalTrials.gov number, NCT00921414 .).

Cannabis and Ecstasy/ MDMA: empirical measures of creativity in recreational users.

PubMed

Jones, Katy A; Blagrove, M; Parrott, A C

2009-12-01

This study investigated the associations between chronic cannabis and Ecstasy/MDMA use and one objective and two subjective measure of creativity. Fifteen abstinent Ecstasy users, 15 abstinent cannabis users, and 15 nondrug-user controls, completed three measures of creativity: the Consequences behavioral test of creativity, self-assessed performance on the Consequences test, and Gough's Trait Self-Report Creative Adjective Checklist. The Consequences test involved five scenarios where possible consequences had to be devised; scoring was conducted by the standard blind rating (by two independent judges) for "remoteness" and "rarity," and by a frequency and rarity of responses method. Cannabis users had significantly more "rare-creative" responses than controls (Tukey, p < 0.05); this effect remained significant with gender as a covariate. There were no significant differences between the groups on the number of standard scoring "remote-creative" ideas or for fluency of responses. On self-rated creativity, there was a significant ANOVA group difference (p < 0.05), with Ecstasy users tending to rate their answers as more creative than controls (Tukey comparison; p = 0.058, two-tailed). Ecstasy users did not differ from controls on the behavioral measures of creativity, although there was a borderline trend for self-assessment of greater creativity. Cannabis users produced significantly more "rare-creative" responses, but did not rate themselves as more creative.

Evaluation of pharmacy students' knowledge and perceptions of pharmacogenetics before and after a simulation activity.

PubMed

Patel, Radha V; Chudow, Melissa; Vo, Teresa T; Serag-Bolos, Erini S

The purpose of this study was to evaluate students' knowledge and perceptions of the clinical application of pharmacogenetics through a simulation activity and to assess communication of pharmacogenetic-guided treatment recommendations utilizing standardized patients. Third-year students in the four-year doctor of pharmacy (PharmD) program at University of South Florida College of Pharmacy completed a pharmacogenetics simulation involving a patient case review, interpretation of pharmacogenetic test results, completion of a situation, background, assessment, recommendation (SBAR) note with drug therapy recommendations, and patient counseling. Voluntary assessments were completed before and after the simulation, which included demographics, knowledge, and perceptions of students' ability to interpret and communicate pharmacogenetic results. Response rates for the pre- and post-simulation assessments were 109 (98%) and 104 (94%), respectively. Correct responses in application-type questions improved after the simulation (74%) compared to before the simulation (44%, p < 0.01). Responses to perception questions shifted towards "strongly agree" or "agree" after the simulation (p < 0.01). The simulation gave students an opportunity to apply pharmacogenetics knowledge and allowed them to gain an appreciation of pharmacists' roles within the pharmacogenetics field. Copyright © 2017 Elsevier Inc. All rights reserved.

[Complete responses in patients with unresectable liver metastases from colorectal cancer with weekly high-dose 5-FU plus one-shot CDDP HAI].

PubMed

Udagawa, M; Okabe, S; Kuwabara, H; Ootsukasa, S; Arai, T; Maruyama, S; Murase, N; Yamashita, H; Iwai, T

1999-10-01

Thirty-two patients with unresectable liver metastases from colorectal cancer, treated by intermittent hepatic arterial infusion of high-dose 5-FU combined with CDDP, were assessed. As a result of this treatment, the overall response rate was 65.6%, and eight patients (25%) which contained three autopsy cases revealed a complete response. The mean doses of 5-FU and CDDP which was administered in the eight patients were 24.3 g and 65 mg, respectively. One of the eight patients showed complete disappearance of liver metastasis on the CT scan after arterial infusion of 4.5 g of 5-FU, and necrosis or disappearance of the tumor was present in more than 2/3 of the whole lesion. Autopsy showed focal or zonal necrosis, distorted reconstruction of architecture, and cholangiolitis of the liver which were administered more than 15 g of 5-FU. Intermittent hepatic arterial infusion of high-dose 5-FU combined with CDDP is proved to be a useful locoregional chemotherapy for liver metastasis from colorectal cancer. We should evolve new treatment modalities for extrahepatic metastases, as HAI combined with the systemic chemotherapeutic regimen.

Exploring Carers' Judgements of Responsibility and Control in Response to the Challenging Behaviour of People with Intellectual Disabilities.

PubMed

Williams, Sophie; Dagnan, Dave; Rodgers, Jacqui; Freeston, Mark

2015-11-01

This study examines Weiner's recent cognitive emotional model which makes a distinction between judgements of control and responsibility and emphasizes the moderation of control by 'mitigating' factors. In response to four vignettes describing two conditions of control (high or low) and mitigating factors (present or absent), questionnaires rating judgements of responsibility and emotional responses (anger and sympathy) were completed by 52 care staff. Analysis of the data for sympathy demonstrated that attributions of control were moderated by communication ability and that the effect of control upon sympathy was mediated by the judgement of responsibility. The data offer tentative support Weiner's account of the mitigation of control attributions in making responsibility judgements and their subsequent effects on emotional responses. Implications for research and clinical work are discussed. © 2015 John Wiley & Sons Ltd.

Delegation of clinical dietetic tasks in military and civilian hospitals: implications for practice.

PubMed

Myers, M E; Gregoire, M B; Spears, M C

1991-12-01

The purposes of our research were two-fold: to determine perceptions of the quality of task performance and to identify dietetic personnel currently performing clinical dietetic tasks in military and civilian hospitals. Questionnaires were returned from 309 dietitians and 208 dietetic support personnel at 151 military and civilian hospitals (73% response overall). For tasks completed by support personnel, no task was rated as having optimum quality, 1 was rated as highly acceptable, 6 as acceptable, 19 as somewhat unacceptable, and 4 as unacceptable. Current performance ratings indicated that 1 task was performed solely by dietitians, 21 were completed by dietitians with assistance, 6 were completed jointly by dietitians and support personnel, 2 were completed by support personnel with supervision by dietitians, and no task was completed independently by support personnel. Tasks were grouped into four categories: basic clinical dietetics (11 tasks), intermediate and in-depth clinical dietetics (12 tasks), outpatient nutrition clinic (5 tasks), and nutrition education (community) (4 tasks). Quality scores for the US Air Force (USAF) hospitals were higher for all task categories except intermediate and in-depth clinical dietetic tasks. The quality scores of support personnel were higher than those of dietitians for all task categories. The USAF performance scores indicated significantly more involvement of support personnel. Generally, the performance scores of dietitians increased with experience; the scores of support personnel decreased with experience. Correlations between quality and performance ratings for individual tasks revealed low to moderate relationships. Our results suggest that additional delegation of tasks to dietetic support personnel may be possible without negatively affecting perceptions of the quality of task outcome.(ABSTRACT TRUNCATED AT 250 WORDS)

Additional 4-week capecitabine during the resting periods after 6-week neoadjuvant chemoradiotherapy in patients with locally advanced rectal cancer: long-term oncologic outcomes.

PubMed

Park, Sang Woo; Kim, Jin Soo; Kim, Ji Yeon; Lee, Kyung Ha

2018-06-01

The aim of this study was to evaluate the long-term outcome of additional 4-week chemotherapy with capecitabine during the resting periods following a 6-week neoadjuvant chemoradiotherapy (NCRT) regimen, in patients with locally advanced rectal cancer. Radiotherapy was delivered to the whole pelvis at a total dose of 50.4 Gy for 6 weeks. Oral capecitabine was administered at a dose of 825 mg/m 2 twice daily for 10 weeks. Surgery was performed 2-4 weeks following the completion of chemotherapy. Between January 2010 and September 2011, 41 patients completed the scheduled neoadjuvant therapy and surgery. The pathologic complete response rate, 5-year overall survival, and 5-year disease-free survival rates were 22%, 85.4%, and 78.0%, respectively. The 5-year systemic recurrence and 5-year local recurrence rates were 22% and 0%, respectively. Additional 4-week chemotherapy with capecitabine, during the resting periods following a 6-week NCRT regimen, has favorable long-term oncologic outcomes. Further randomized controlled trials are however necessary to evaluate if substantial improvement in local control is achieved with this additional chemotherapy modality for locally advanced rectal cancer.

Adaptive Randomization of Veliparib-Carboplatin Treatment in Breast Cancer.

PubMed

Rugo, Hope S; Olopade, Olufunmilayo I; DeMichele, Angela; Yau, Christina; van 't Veer, Laura J; Buxton, Meredith B; Hogarth, Michael; Hylton, Nola M; Paoloni, Melissa; Perlmutter, Jane; Symmans, W Fraser; Yee, Douglas; Chien, A Jo; Wallace, Anne M; Kaplan, Henry G; Boughey, Judy C; Haddad, Tufia C; Albain, Kathy S; Liu, Minetta C; Isaacs, Claudine; Khan, Qamar J; Lang, Julie E; Viscusi, Rebecca K; Pusztai, Lajos; Moulder, Stacy L; Chui, Stephen Y; Kemmer, Kathleen A; Elias, Anthony D; Edmiston, Kirsten K; Euhus, David M; Haley, Barbara B; Nanda, Rita; Northfelt, Donald W; Tripathy, Debasish; Wood, William C; Ewing, Cheryl; Schwab, Richard; Lyandres, Julia; Davis, Sarah E; Hirst, Gillian L; Sanil, Ashish; Berry, Donald A; Esserman, Laura J

2016-07-07

The genetic and clinical heterogeneity of breast cancer makes the identification of effective therapies challenging. We designed I-SPY 2, a phase 2, multicenter, adaptively randomized trial to screen multiple experimental regimens in combination with standard neoadjuvant chemotherapy for breast cancer. The goal is to match experimental regimens with responding cancer subtypes. We report results for veliparib, a poly(ADP-ribose) polymerase (PARP) inhibitor, combined with carboplatin. In this ongoing trial, women are eligible for participation if they have stage II or III breast cancer with a tumor 2.5 cm or larger in diameter; cancers are categorized into eight biomarker subtypes on the basis of status with regard to human epidermal growth factor receptor 2 (HER2), hormone receptors, and a 70-gene assay. Patients undergo adaptive randomization within each biomarker subtype to receive regimens that have better performance than the standard therapy. Regimens are evaluated within 10 biomarker signatures (i.e., prospectively defined combinations of biomarker subtypes). Veliparib-carboplatin plus standard therapy was considered for HER2-negative tumors and was therefore evaluated in 3 signatures. The primary end point is pathological complete response. Tumor volume changes measured by magnetic resonance imaging during treatment are used to predict whether a patient will have a pathological complete response. Regimens move on from phase 2 if and when they have a high Bayesian predictive probability of success in a subsequent phase 3 neoadjuvant trial within the biomarker signature in which they performed well. With regard to triple-negative breast cancer, veliparib-carboplatin had an 88% predicted probability of success in a phase 3 trial. A total of 72 patients were randomly assigned to receive veliparib-carboplatin, and 44 patients were concurrently assigned to receive control therapy; at the completion of chemotherapy, the estimated rates of pathological complete response in the triple-negative population were 51% (95% Bayesian probability interval [PI], 36 to 66%) in the veliparib-carboplatin group versus 26% (95% PI, 9 to 43%) in the control group. The toxicity of veliparib-carboplatin was greater than that of the control. The process used in our trial showed that veliparib-carboplatin added to standard therapy resulted in higher rates of pathological complete response than standard therapy alone specifically in triple-negative breast cancer. (Funded by the QuantumLeap Healthcare Collaborative and others; I-SPY 2 TRIAL ClinicalTrials.gov number, NCT01042379.).

Fitness Costs and Diversity of the Cytotoxic T Lymphocyte (CTL) Response Determine the Rate of CTL Escape during Acute and Chronic Phases of HIV Infection▿†

PubMed Central

Ganusov, Vitaly V.; Goonetilleke, Nilu; Liu, Michael K. P.; Ferrari, Guido; Shaw, George M.; McMichael, Andrew J.; Borrow, Persephone; Korber, Bette T.; Perelson, Alan S.

2011-01-01

HIV-1 often evades cytotoxic T cell (CTL) responses by generating variants that are not recognized by CTLs. We used single-genome amplification and sequencing of complete HIV genomes to identify longitudinal changes in the transmitted/founder virus from the establishment of infection to the viral set point at 1 year after the infection. We found that the rate of viral escape from CTL responses in a given patient decreases dramatically from acute infection to the viral set point. Using a novel mathematical model that tracks the dynamics of viral escape at multiple epitopes, we show that a number of factors could potentially contribute to a slower escape in the chronic phase of infection, such as a decreased magnitude of epitope-specific CTL responses, an increased fitness cost of escape mutations, or an increased diversity of the CTL response. In the model, an increase in the number of epitope-specific CTL responses can reduce the rate of viral escape from a given epitope-specific CTL response, particularly if CD8+ T cells compete for killing of infected cells or control virus replication nonlytically. Our mathematical framework of viral escape from multiple CTL responses can be used to predict the breadth and magnitude of HIV-specific CTL responses that need to be induced by vaccination to reduce (or even prevent) viral escape following HIV infection. PMID:21835793

Fitness costs and diversity of the cytotoxic T lymphocyte (CTL) response determine the rate of CTL escape during acute and chronic phases of HIV infection.

PubMed

Ganusov, Vitaly V; Goonetilleke, Nilu; Liu, Michael K P; Ferrari, Guido; Shaw, George M; McMichael, Andrew J; Borrow, Persephone; Korber, Bette T; Perelson, Alan S

2011-10-01

HIV-1 often evades cytotoxic T cell (CTL) responses by generating variants that are not recognized by CTLs. We used single-genome amplification and sequencing of complete HIV genomes to identify longitudinal changes in the transmitted/founder virus from the establishment of infection to the viral set point at 1 year after the infection. We found that the rate of viral escape from CTL responses in a given patient decreases dramatically from acute infection to the viral set point. Using a novel mathematical model that tracks the dynamics of viral escape at multiple epitopes, we show that a number of factors could potentially contribute to a slower escape in the chronic phase of infection, such as a decreased magnitude of epitope-specific CTL responses, an increased fitness cost of escape mutations, or an increased diversity of the CTL response. In the model, an increase in the number of epitope-specific CTL responses can reduce the rate of viral escape from a given epitope-specific CTL response, particularly if CD8+ T cells compete for killing of infected cells or control virus replication nonlytically. Our mathematical framework of viral escape from multiple CTL responses can be used to predict the breadth and magnitude of HIV-specific CTL responses that need to be induced by vaccination to reduce (or even prevent) viral escape following HIV infection.

Naltrexone for impulse control disorders in Parkinson disease

PubMed Central

Papay, Kimberly; Xie, Sharon X.; Stern, Matthew; Hurtig, Howard; Siderowf, Andrew; Duda, John E.; Minger, James

2014-01-01

Objective: Impulse control disorders (ICDs) in Parkinson disease (PD) are common and can be difficult to manage. The objective of this study was to determine the efficacy and tolerability of naltrexone, an opioid antagonist, for the treatment of ICDs in PD. Methods: Patients with PD (n = 50) and an ICD were enrolled in an 8-week, randomized (1:1), double-blind, placebo-controlled study of naltrexone 50–100 mg/d (flexible dosing). The primary outcome measure was response based on the Clinical Global Impression–Change score, and the secondary outcome measure was change in symptom severity using the Questionnaire for Impulsive-Compulsive Disorders in Parkinson's Disease–Rating Scale (QUIP-RS) ICD score. Results: Forty-five patients (90%) completed the study. The Clinical Global Impression–Change response rate difference favoring naltrexone in completers was 19.8% (95% confidence interval [CI] −8.7% to 44.2%). While this difference was not significant (odds ratio = 1.6, 95% CI 0.5–5.2, Wald χ2 [df] = 0.5 [1], p = 0.5), naltrexone treatment led to a significantly greater decrease in QUIP-RS ICD score over time compared with placebo (regression coefficient for interaction term in linear mixed-effects model = −7.37, F[df] = 4.3 [1, 49], p = 0.04). The estimated changes in QUIP-RS ICD scores from baseline to week 8 were 14.9 points (95% CI 9.9–19.9) for naltrexone and 7.5 points (95% CI 2.5–12.6) for placebo. Conclusions: Naltrexone treatment was not efficacious for the treatment of ICDs in PD using a global assessment of response, but findings using a PD-specific ICD rating scale support further evaluation of opioid antagonists for the treatment of ICD symptoms in PD. Classification of evidence: This study provides Class I evidence that in patients with PD and an ICD, naltrexone does not significantly increase the probability of achieving response. However, the study lacked the precision to exclude an important difference in response rates. PMID:25037206

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

Shim, Su Jung; Yang, Woo-Ick; Shin, Eunah

Purpose: To determine whether there are any differences in therapeutic response, patterns of systemic recurrence, and prognosis of patients with extranodal natural killer (NK)/T-cell lymphoma, nasal type, by the cyclooxygenase-2 (COX-2) expression. Patients and Methods: Thirty-four patients with Ann Arbor Stage I and II extranodal NK/T-cell lymphoma who underwent chemotherapy or radiotherapy, or both, were retrospectively reviewed. These patients were divided into two groups according to their immunohistochemical staining for COX-2 expressions: a COX-2-negative group (n = 10 patients) and a COX-2-positive group (n = 24 patients). The treatment response, patterns of treatment failure, and survival data for the patientsmore » were compared between the COX-2-positive and negative groups. Results: There was no significant difference in the clinical profiles between the COX-2-negative and COX-2-positive groups. All patients (100%) in the COX-2-negative group achieved complete response after initial treatment, whereas only 14 patients (58%) in the COX-2-positive group achieved complete response (p = 0.03). Compared with the patients in the COX-2-negative group, those in the COX-2-positive group had a significantly lower 2-year systemic recurrence-free survival rate (100% for the COX-2-negative group vs. 54% for the COX-2-positive group) (p = 0.02) and a decreased 5-year overall survival rate (70% for the COX-2-negative group vs. 32% for the COX-2-positive group) (p = 0.06). Conclusion: Cyclooxygenase-2 expression can serve as a predictive factor for poor treatment response, higher systemic recurrence, and unfavorable prognosis in patients with extranodal NK/T-cell lymphoma, nasal type.« less

Sequential therapy with entecavir and PEG-INF in patients affected by chronic hepatitis B and high levels of HBV-DNA with non-D genotypes.

PubMed

Boglione, L; D'Avolio, A; Cariti, G; Milia, M G; Simiele, M; De Nicolò, A; Ghisetti, V; Di Perri, G

2013-04-01

Complete eradication of hepatitis B virus (HBV) is rarely achieved. Treatment options include currently available nucleos(t)ide analogues and pegylated interferon. The aim of our exploratory study was to assess the effectiveness of sequential therapy for chronic hepatitis B (CHB) vs the current standard of care. We evaluated an association with entecavir and pegylated interferon alfa-2a (PEG-IFN) in 20 patients with hepatitis B, high HBV viremia and genotypes A, B, C and E. Patients received entecavir alone for 12 weeks, then entecavir and PEG-IFN for 12 weeks, lastly PEG-IFN alone for 36 weeks. The results were compared with 20 patients (control group) treated in the past with 48 weeks of PEG-IFN monotherapy. Our results show that complete sustained virological response (SVR) and partial SVR were, respectively, 60% and 80% in the study group and 10% and 30% in the control group; anti-HBe seroconversion rate were 76.9% vs 15%, and anti-HBs seroconversion were 20% vs 0%, respectively. We found a correlation among different genotypes and virological and serological outcomes - genotype C has a better virological response, while genotype A had a better serological response, and E genotype had a poor response. These results show that a sequential approach is a promising strategy of treatment in patients with CHB and high viremia in comparison with PEG-IFN monotherapy. The E genotype seems to have the worse rate of response and requires other treatment strategies. © 2013 Blackwell Publishing Ltd.

Development of a Research Participants’ Perception Survey to Improve Clinical Research

PubMed Central

Yessis, Jennifer L.; Kost, Rhonda G.; Lee, Laura M.; Coller, Barry S.; Henderson, David K.

2012-01-01

Abstract Introduction: Clinical research participants’ perceptions regarding their experiences during research protocols provide outcome‐based insights into the effectiveness of efforts to protect rights and safety, and opportunities to enhance participants’ clinical research experiences. Use of validated surveys measuring patient‐centered outcomes is standard in hospitals, yet no instruments exist to assess outcomes of clinical research processes. Methods: We derived survey questions from data obtained from focus groups comprised of research participants and professionals. We assessed the survey for face/content validity, and privacy/confidentiality protections and fielded it to research participants at 15 centers. We conducted analyses of response rates, sample characteristics, and psychometrics, including survey and item completion and analysis, internal consistency, item internal consistency, criterion‐related validity, and item usefulness. Responses were tested for fit into existing patient‐centered dimensions of care and new clinical research dimensions using Cronbach's alpha coefficient. Results: Surveys were mailed to 18,890 individuals; 4,961 were returned (29%). Survey completion was 89% overall; completion rates exceeded 90% for 88 of 93 evaluable items. Questions fit into three dimensions of patient‐centered care and two novel clinical research dimensions (Cronbach's alpha for dimensions: 0.69–0.85). Conclusions: The validated survey offers a new method for assessing and improving outcomes of clinical research processes. Clin Trans Sci 2012; Volume 5: 452–460 PMID:23253666

Effect of phorbol derivatives and staurosporine on gravitropic response of primary root of maize

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

Mulkey, T.J.; Kim, S.Y.; Lee, J.S.

1991-05-01

Time-lapse videography and computer-based, video image digitization were used to examine the effects of phorbol derivatives (phorbol 12-myristate 13-acetate, TPA; phorbol 12-myristate 13-acetate 4-O-methyl ether, mTPA) and staurosporine on the kinetics of gravicurvature of primary roots of maize (Zea mays L., Pioneer 3343 and Golden Cross Bantam). Pretreatment of roots with TPA (3 hr, 1 {mu}M) decreases the time lag prior to induction of positive gravicurvature in horizontally-oriented roots by > 60%. The rate of curvature is not significantly different than the rate observed in control roots. Wrongway curvature which is observed in 30-40% of control roots is not observedmore » in TPA-pretreated roots. Oscillatory movements observed in control roots after completion of gravitropic reorientation is completely dampened in TPA-pretreated roots. Pretreatment of roots with mTPA(3hr,1{mu}M), the inactive analog of TPA, does not significantly alter the kinetics of gravicurvature of primary roots of maize. Staurosporine (10{sup {minus}8}M), a microbial alkaloid which has been reported to have antifungal activity and to inhibit phospholipid/Ca{sup ++} dependent protein kinase, completely inhibits TPA-induced alteration of the kinetics of gravitropism. DAG (1-oleoyl-2-acetyl-rac-glycerol), a synthetic diglyceride activator of protein kinase C, exhibits similar activity to TPA. TPA-induced alterations in tissue response to auxin are presented.« less

Impact of euthanasia rates, euthanasia practices, and human resource practices on employee turnover in animal shelters.

PubMed

Rogelberg, Steven G; Reeve, Charlie L; Spitzmüller, Christiane; DiGiacomo, Natalie; Clark, Olga L; Teeter, Lisa; Walker, Alan G; Starling, Paula G; Carter, Nathan T

2007-03-01

To examine the effects of euthanasia rates, euthanasia practices, and human resource practices on the turnover rate among employees with euthanasia responsibilities at animal shelters. Cross-sectional original study. 36 shelters across the United States that employed at least 5 full-time employees and performed euthanasia on site. By mail, 1 survey was sent to each shelter. Surveys were completed by a senior member of management and were returned by mail. Questions assessed characteristics (eg, euthanasia rates) and practices of the animal shelter, along with employee turnover rates. By use of correlation coefficients and stepwise regression analyses, key predictors of turnover rates among employees with euthanasia responsibilities were investigated. Employee turnover rates were positively related to euthanasia rate. Practices that were associated with decreased turnover rates included provision of a designated euthanasia room, exclusion of other live animals from vicinity during euthanasia, and removal of euthanized animals from a room prior to entry of another animal to be euthanized. Making decisions regarding euthanasia of animals on the basis of factors other than behavior and health reasons was related to increased personnel turnover. With regard to human resources practices, shelters that used a systematic personnel selection procedure (eg, standardized testing) had comparatively lower employee turnover. Data obtained may suggest several specific avenues that can be pursued to mitigate turnover among employees with euthanasia responsibilities at animal shelters and animal control or veterinary medical organizations.

Collection of social determinants of health in the community clinic setting: a cross-sectional study.

PubMed

Kusnoor, Sheila V; Koonce, Taneya Y; Hurley, Suzanne T; McClellan, Kalonji M; Blasingame, Mallory N; Frakes, Elizabeth T; Huang, Li-Ching; Epelbaum, Marcia I; Giuse, Nunzia B

2018-04-24

Addressing social and behavioral determinants of health (SBDs) may help improve health outcomes of community clinic patients. This cross-sectional study explored how assessing SBDs can be used to complement health data collection strategies and provide clinicians with a more in-depth understanding of their patients. Adult patients, ages 18 and older, at an urban community health care clinic in Tennessee, U.S.A., were asked to complete a questionnaire regarding health status, health history and SBDs while waiting for their clinic appointment. The SBD component included items from the National Academy of Medicine, the Protocol for Responding to and Assessing Patient Assets, Risks, and Experiences instrument, and the Survey of Household Economics and Decisionmaking. Data collection and analysis occurred in 2017. One hundred participants completed the study. The questionnaire took approximately 11 min to complete, and the response rate was 90% or higher for all items except annual household income (unanswered by 40 participants). The median number of negative SBDs was 4 (IQR 2.75-7.0), 96 participants had at least one unmet need, and the most common negative SBD was physical activity (75%; 75/100). The hybrid questionnaire provided insight into a community clinic population's SBDs and allowed for a more complete understanding than a single questionnaire alone. The brief questionnaire administration time and low non-response rate support the questionnaire's feasibility in the community clinic setting, and results can be used by clinicians to further the personalization goals of precision medicine. Next steps include evaluating how to connect patients with appropriate resources for addressing their SBDs.

Physical capacity of rescue personnel in the mining industry

PubMed Central

Stewart, Ian B; McDonald, Michael D; Hunt, Andrew P; Parker, Tony W

2008-01-01

Background The mining industry has one of the highest occupational rates of serious injury and fatality. Mine staff involved with rescue operations are often required to respond to physically challenging situations. This paper describes the physical attributes of mining rescue personnel. Methods 91 rescue personnel (34 ± 8.6 yrs, 1.79 ± 0.07 m, 90 ± 15.0 kg) participating in the Queensland Mines Rescue Challenge completed a series of health-related and rescue-related fitness tasks. Health-related tasks comprised measurements of aerobic capacity (VO2max), abdominal endurance, abdominal strength, flexibility, lower back strength, leg strength, elbow flexion strength, shoulder strength, lower back endurance, and leg endurance. Rescue-related tasks comprised an incremental carry (IC), coal shovel (CS), and a hose drag (HD), completed in this order. Results Cardiovascular (VO2max) and muscular endurance was average or below average compared with the general population. Isometric strength did not decline with age. The rescue-related tasks were all extremely demanding with heart rate responses averaging greater than 88% of age predicted maximal heart rates. Heart rate recovery responses were more discriminating than heart rates recorded during the tasks, indicating the hose drag as the most physically demanding of the tasks. Conclusion Relying on actual rescues or mining related work to provide adequate training is generally insufficient to maintain, let alone increase, physical fitness. It is therefore recommended that standards of required physical fitness be developed and mines rescue personnel undergo regularly training (and assessment) in order to maintain these standards. PMID:18847510

Quantifying cardiorespiratory responses resulting from speed and slope increments during motorized treadmill propulsion among manual wheelchair users.

PubMed

Gauthier, Cindy; Grangeon, Murielle; Ananos, Ludivine; Brosseau, Rachel; Gagnon, Dany H

2017-09-01

Cardiorespiratory fitness assessment and training among manual wheelchair (MW) users are predominantly done with an arm-crank ergometer. However, arm-crank ergometer biomechanics differ substantially from MW propulsion biomechanics. This study aimed to quantify cardiorespiratory responses resulting from speed and slope increments during MW propulsion on a motorized treadmill and to calculate a predictive equation based on speed and slope for estimating peak oxygen uptake (VO 2peak ) in MW users. In total, 17 long-term MW users completed 12 MW propulsion periods (PP), each lasting 2min, on a motorized treadmill, in a random order. Each PP was separated by a 2-min rest. PPs were characterized by a combination of 3 speeds (0.6, 0.8 and 1.0m/s) and 4 slopes (0°, 2.7°, 3.6° and 4.8°). Six key cardiorespiratory outcome measures (VO 2 , heart rate, respiratory rate, minute ventilation and tidal volume) were recorded by using a gas-exchange analysis system. Rate of perceived exertion (RPE) was measured by using the modified 10-point Borg scale after each PP. For the 14 participants who completed the test, cardiorespiratory responses increased in response to speed and/or slope increments, except those recorded between the 3.6 o and 4.8 o slope, for which most outcome measures were comparable. The RPE was positively associated with cardiorespiratory response (r s ≥0.85). A VO 2 predictive equation (R 2 =99.7%) based on speed and slope for each PP was computed. This equation informed the development of a future testing protocol to linearly increase VO 2 via 1-min stages during treadmill MW propulsion. Increasing speed and slope while propelling a MW on a motorized treadmill increases cardiorespiratory response along with RPE. RPE can be used to easily and accurately monitor cardiorespiratory responses during MW exercise. The VO 2 can be predicted to some extent by speed and slope during MW propulsion. A testing protocol is proposed to assess cardiorespiratory fitness during motorized MW propulsion. Copyright © 2017 Elsevier Masson SAS. All rights reserved.

Comparison of cyclophosphamide-thalidomide-dexamethasone to bortezomib-cyclophosphamide-dexamethasone as induction therapy for multiple myeloma patients in Brazil.

PubMed

Vigolo, Suelen; Zuckermann, Joice; Bittencourt, Rosane Isabel; Silla, Lúcia; Pilger, Diogo André

2017-09-01

Chemotherapy followed by autologous hematopoietic stem cell transplantation (HSCT) remains the standard treatment for multiple myeloma (MM). Thalidomide or bortezomib may be combined with cyclophosphamide and dexamethasone, in what are known as the CTD and VCD protocols, respectively. The objective of this study was to evaluate the clinical characteristics and response rates obtained with CTD and VCD, observing whether the inclusion of bortezomib to treat MM patients in Brazil increases therapeutic efficiency. Forty-three MM patients treated with induction protocols CTD and VCD between January 2010 and March 2015 were included. The parameters analyzed were staging, frequency of comorbidities prior to treatment, response rates obtained at each induction cycle, progression-free survival, and overall survival of patients. Very good partial response and complete response obtained with the VCD protocol were superior, compared with the CTD treatment. The presence of comorbidities was similar in the two groups, except kidney failure, which prevailed in the VCD group. Also, 78.3% and 48.3% of patients treated with the VCD and CTD protocols underwent autologous HSCT, respectively. In patients given the VCD protocol, 45.5% had complete response before autologous HSCT. Among those given CTD, this number was only 7.1% (p=0.023). Disease progression after autologous HSCT did not differ between the two groups. VCD afforded better responses than the CTD protocol, and improved patient condition before autologous HSCT. However, more studies are necessary including more patients and addressing various clinical conditions, besides the analysis of cost-effectiveness of these treatments. Copyright © 2017 King Faisal Specialist Hospital & Research Centre. Published by Elsevier B.V. All rights reserved.

Vancomycin Ophthalmic Ointment 1% for methicillin-resistant Staphylococcus aureus or methicillin-resistant Staphylococcus epidermidis infections: a case series

PubMed Central

Sotozono, Chie; Fukuda, Masahiko; Ohishi, Masao; Yano, Keiko; Origasa, Hideki; Saiki, Yoshinori; Shimomura, Yoshikazu; Kinoshita, Shigeru

2013-01-01

Objectives To investigate the efficacy and safety of Vancomycin Ophthalmic Ointment 1% (Toa Pharmaceutical Co., Ltd, Toyama, Japan) in patients with external ocular infections caused by methicillin-resistant Staphylococcus aureus (MRSA) or methicillin-resistant Staphylococcus epidermidis (MRSE). Design A case series. Setting This study was a multicentre, open-label, uncontrolled study in Japan approved as orphan drug status. Participants Patients with MRSA or MRSE external ocular infections unresponsive to the treatment of fluoroquinolone eye drops. Interventions Vancomycin Ophthalmic Ointment 1% was administered four times daily. Primary and secondary outcome measures The subjective and objective clinical scores and bacterial cultures were collected at days 0 (baseline), 3, 7 and 14. The primary outcome was clinical response evaluation (efficacy rate) determined as complete response, partial response, no response and worsening. Secondary outcome was the eradication of the bacteria. Safety was assessed by adverse events including cases in which neither MRSA nor MRSE was detected. Results Twenty-five cases with MRSA (20) or MRSE (5) infections were enrolled. Of these 25 cases, 4 discontinued the treatment due to the negative results for bacterial culture during screening or at baseline. Of the 21 cases with conjunctivitis (14), blepharitis (3), meibomitis (1), dacryocystitis (2) or keratitis (1), 14 (66.7%) cases were evaluated as being excellently (complete response, 2 cases) or well (partial response, 12 cases) treated. The eradication rates were 68.4% in MRSA (13 of 19 cases) and 100% in MRSE (2 of 2 cases). Ten adverse events occurred in 7 (28.0%) of 25 cases at the local administration site. Conclusions Vancomycin Ophthalmic Ointment 1% was considered to be useful for the treatment of intractable ocular MRSA/MRSE infections. PMID:23364319

Restoration of Hindlimb Movements after Complete Spinal Cord Injury Using Brain-Controlled Functional Electrical Stimulation.

PubMed

Knudsen, Eric B; Moxon, Karen A

2017-01-01

Single neuron and local field potential signals recorded in the primary motor cortex have been repeatedly demonstrated as viable control signals for multi-degree-of-freedom actuators. Although the primary source of these signals has been fore/upper limb motor regions, recent evidence suggests that neural adaptation underlying neuroprosthetic control is generalizable across cortex, including hindlimb sensorimotor cortex. Here, adult rats underwent a longitudinal study that included a hindlimb pedal press task in response to cues for specific durations, followed by brain machine interface (BMI) tasks in healthy rats, after rats received a complete spinal transection and after the BMI signal controls epidural stimulation (BMI-FES). Over the course of the transition from learned behavior to BMI task, fewer neurons were responsive after the cue, the proportion of neurons selective for press duration increased and these neurons carried more information. After a complete, mid-thoracic spinal lesion that completely severed both ascending and descending connections to the lower limbs, there was a reduction in task-responsive neurons followed by a reacquisition of task selectivity in recorded populations. This occurred due to a change in pattern of neuronal responses not simple changes in firing rate. Finally, during BMI-FES, additional information about the intended press duration was produced. This information was not dependent on the stimulation, which was the same for short and long duration presses during the early phase of stimulation, but instead was likely due to sensory feedback to sensorimotor cortex in response to movement along the trunk during the restored pedal press. This post-cue signal could be used as an error signal in a continuous decoder providing information about the position of the limb to optimally control a neuroprosthetic device.

Student Evaluations of Teaching: Dental and Dental Hygiene Students' and Faculty Members' Perspectives.

PubMed

Grillo, Andrew C; Murdoch-Kinch, Carol Anne; Ramaswamy, Vidya; Inglehart, Marita R

2016-04-01

The aim of this study was to explore dental and dental hygiene students' and faculty members' perceptions of student evaluations of teaching (SET) and determine whether dental vs. dental hygiene student, beginning vs. advanced student, and faculty vs. student responses differed. Perceived benefits, challenges, and suggestions for conducting SETs optimally were also assessed. Survey data were collected from 329 dental students (D1: 108; D2: 91; D3&4: 130) and 68 dental hygiene students (DH2: 26; DH3: 19; DH4: 23) (overall response rates 76%/92%) and 56 dental and eight dental hygiene faculty members (response rates 41%/100%). Faculty respondents were more positive about SETs than students (five-point scale with 1=disagree: 3.85 vs. 3.39; p<0.001), with seniors being the least positive (mean 2.42). Respondents agreed that all students should complete SETs (3.87 vs. 3.61; p=0.068), with faculty agreeing more strongly than students that all courses should be evaluated (4.32/4.04; p=0.046). Students agreed more strongly than faculty that SETs should occur during regular class time (3.97/3.44; p<0.001) and are too long (3.47/3.09; p=0.010) and that results should be shared with students (4.03/3.57; p=0.002). Open-ended responses showed that students perceived more benefits of SETs for faculty members than for students and that the most frequently mentioned problem was that SETs do not result in changes. Faculty members were generally more positive than students (especially seniors) about SETs. These findings suggest that, according to these respondents, SETs should be completed by all students for all courses, be short, provide opportunities for open-ended comments, and be administered in class to improve response rate. In addition, SET results and how SETs are used to improve courses should be shared with students.

Chimeric antigen receptor T cells persist and induce sustained remissions in relapsed refractory chronic lymphocytic leukemia

PubMed Central

Porter, David L.; Hwang, Wei-Ting; Frey, Noelle V.; Lacey, Simon F.; Shaw, Pamela A.; Loren, Alison W.; Bagg, Adam; Marcucci, Katherine T.; Shen, Angela; Gonzalez, Vanessa; Ambrose, David; Grupp, Stephan A.; Chew, Anne; Zheng, Zhaohui; Milone, Michael C.; Levine, Bruce L.; Melenhorst, Jan J.; June, Carl H.

2018-01-01

Patients with multiply relapsed or refractory chronic lymphocytic leukemia (CLL) have a poor prognosis. Chimeric antigen receptor (CAR)–modified T cells targeting CD19 have the potential to improve on the low complete response rates with conventional therapies by inducing sustained remissions in patients with refractory B cell malignancies. We previously reported preliminary results on three patients with refractory CLL. We report the mature results from our initial trial using CAR-modified T cells to treat 14 patients with relapsed and refractory CLL. Autologous T cells transduced with a CD19-directed CAR (CTL019) lentiviral vector were infused into patients with relapsed/refractory CLL at doses of 0.14 × 108 to 11 × 108 CTL019 cells (median, 1.6 × 108 cells). Patients were monitored for toxicity, response, expansion, and persistence of circulating CTL019 T cells. The overall response rate in these heavily pretreated CLL patients was 8 of 14 (57%), with 4 complete remissions (CR) and 4 partial remissions (PR). The in vivo expansion of the CAR T cells correlated with clinical responses, and the CAR T cells persisted and remained functional beyond 4 years in the first two patients achieving CR. No patient in CR has relapsed. All responding patients developed B cell aplasia and experienced cytokine release syndrome, coincident with T cell proliferation. Minimal residual disease was not detectable in patients who achieved CR, suggesting that disease eradication may be possible in some patients with advanced CLL. PMID:26333935

Construct validation of an interactive digital algorithm for ostomy care.

PubMed

Beitz, Janice M; Gerlach, Mary A; Schafer, Vickie

2014-01-01

The purpose of this study was to evaluate construct validity for a previously face and content validated Ostomy Algorithm using digital real-life clinical scenarios. A cross-sectional, mixed-methods Web-based survey design study was conducted. Two hundred ninety-seven English-speaking RNs completed the study; participants practiced in both acute care and postacute settings, with 1 expert ostomy nurse (WOC nurse) and 2 nonexpert nurses. Following written consent, respondents answered demographic questions and completed a brief algorithm tutorial. Participants were then presented with 7 ostomy-related digital scenarios consisting of real-life photos and pertinent clinical information. Respondents used the 11 assessment components of the digital algorithm to choose management options. Participant written comments about the scenarios and the research process were collected. The mean overall percentage of correct responses was 84.23%. Mean percentage of correct responses for respondents with a self-reported basic ostomy knowledge was 87.7%; for those with a self-reported intermediate ostomy knowledge was 85.88% and those who were self-reported experts in ostomy care achieved 82.77% correct response rate. Five respondents reported having no prior ostomy care knowledge at screening and achieved an overall 45.71% correct response rate. No negative comments regarding the algorithm were recorded by participants. The new standardized Ostomy Algorithm remains the only face, content, and construct validated digital clinical decision instrument currently available. Further research on application at the bedside while tracking patient outcomes is warranted.

Patterning of physiological and affective responses in older active adults during a maximal graded exercise test and self-selected exercise.

PubMed

Smith, Ashleigh E; Eston, Roger; Tempest, Gavin D; Norton, Belinda; Parfitt, Gaynor

2015-09-01

The American College of Sports Medicine has highlighted the importance of considering the physiological and affective responses to exercise when setting exercise intensity. Here, we examined the relationship between exercise intensity and physiological and affective responses in active older adults. Eighteen participants (60-74 years; 64.4 ± 3.9; 8 women) completed a maximal graded exercise test (GXT) on a treadmill. Since time to exhaustion in the GXT differed between participants, heart rate (HR), oxygen consumption (VO2), affective valence (affect) and rating of perceived exertion (RPE) were expressed relative to the individually determined ventilatory threshold (%atVT). During the GXT, VO2, HR and RPE increased linearly (all P < 0.01). Affect declined initially (but remained positive) (P = 0.03), stabilised around VT (still positive) (P > 0.05) and became negative towards the end of the test (P < 0.01). In a subsequent session, participants completed a 20-min bout of self-selected exercise (at a preferred intensity). Initially, participants chose to exercise below VT (88.2 ± 17.4 %VO2atVT); however, the intensity was adjusted to work at, or above VT (107.7 ± 19.9 %VO2atVT) after 10 min (P < 0.001), whilst affect remained positive. Together, these findings indicate that exercise around VT, whether administered during an exercise test, or self-selected by the participant, is likely to result in positive affective responses in older adults.

Tumor Heterogeneity of FIGO Stage III Carcinoma of the Uterine Cervix

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

Kim, Yong Bae; Lee, Ik Jae; Kim, Song Yih

2009-12-01

Purpose: The purpose of this study was to analyze tumor heterogeneity based on tumor extent and suggest reappraisal of the system of the International Federation of Gynecology and Obstetrics (FIGO) for Stage III carcinoma of the uterine cervix from a radiotherapeutic viewpoint. Methods and Materials: Between 1986 and 2004, 407 patients with FIGO Stage III (FIGO Stage IIIa in 19 and IIIb in 388) were treated with external beam radiotherapy (RT) and high-dose rate brachytherapy. All patients were reviewed with respect to tumor extent. Patterns of failure and survival parameters were analyzed by use of the chi{sup 2} test andmore » Kaplan-Meier method. Results: The complete response rate was 79.6%, and the 5-year overall survival rates for Stage IIIa and Stage IIIb carcinoma of the cervix were 82.1% and 54.8%, respectively. To determine which parameters of tumor extent had an influence on prognosis for Stage IIIb patients, pelvic wall (PW) extension and hydronephrosis (HD) retained significance on multivariate analysis. Stage IIIb patients were divided into three subgroups according to PW extension and HD: low risk (unilateral PW extension without HD), intermediate risk (HD without PW extension or bilateral PW extension without HD), and high risk (unilateral or bilateral PW extension with HD). The high-risk group had a remarkably low complete response rate, high locoregional failure rate, and low 5-year survival rate compared with the intermediate- and low-risk groups. Conclusions: FIGO Stage III carcinoma of the cervix covers considerably heterogeneous subgroups according to tumor extent. Before initiation of treatment, we suggest that physicians determine a tailored treatment policy based on tumor heterogeneity for each Stage III patient.« less

Physiological responses to indoor rock-climbing and their relationship to maximal cycle ergometry.

PubMed

Sheel, A William; Seddon, Nicholas; Knight, Andrew; McKenzie, Donald C; R Warburton, Darren E

2003-07-01

To quantify the cardiorespiratory responses to indoor climbing during two increasingly difficult climbs and relate them to whole-body dynamic exercise. It was hypothesized that as climbing difficulty increased, oxygen consumption ([V02] and heart rate would increase, and that climbing would require utilization of a significant fraction of maximal cycling values. Elite competitive sport rock climbers (6 male, 3 female) completed two data collection sessions. The first session was completed at an indoor climbing facility, and the second session was an incremental cycle test to exhaustion. During indoor climbing subjects were randomly assigned to climb two routes designated as "harder" or "easier" based on their previous best climb. Subjects wore a portable metabolic system, which allowed measurement of oxygen consumption [V02], minute ventilation ([V02]E), respiratory exchange ratio (RER), and heart rate. During the second session, maximal values for [V02], [V02]E, RER, and heart rate were determined during an incremental cycle test to exhaustion. Heart rate and [VO2], expressed as percent of cycling maximum, were significantly higher during harder climbing compared with easier climbing. During harder climbing, %HR(max) was significantly higher than %[V02] (2max) (89.6% vs 51.2%), and during easier climbing, %HR(max) was significantly higher than %[V02] (2max) (66.9% vs 45.3%). With increasing levels of climbing difficulty, there is a rise in both heart rate and [V02]. However, there is a disproportional rise in heart rate compared with [V02], which we attribute to the fact that climbing requires the use of intermittent isometric contractions of the arm musculature and the reliance of both anaerobic and aerobic metabolism.

A Logistic Regression Analysis of Student Experience Factors for the Enhancement of Developmental Post-Secondary Retention Initiatives

ERIC Educational Resources Information Center

Shenkle, Michael Thomas

2017-01-01

In response to stagnant undergraduate completion rates and growing demands for post-secondary accountability, institutions are actively pursuing effective, broadly applicable methods for promoting student success. One notable scarcity in existing research is found in the tailoring of broad academic interventions to better meet the specific needs…

Effects of Video Games as Reinforcers for Computerized Addition Performance.

ERIC Educational Resources Information Center

Axelrod, Saul; And Others

1987-01-01

Four 2nd-grade students completed addition problems on a computer, using video games as reinforcers. Two variable ratio schedules of reinforcement failed to increase student accuracy or the rate of correct responses. In a no-games reinforcement condition, students had more opportunities to respond and had a greater number of correct answers.…

Helping Students Pay for College--and Achieve Better Outcomes

ERIC Educational Resources Information Center

MDRC, 2013

2013-01-01

America faces a two-pronged problem in higher education: increasing costs and low completion rates. Despite the recent expansion of federal Pell Grants, many students still are left with unmet financial needs and may drop out of college because of financial concerns, pressing work responsibilities, and fears of taking on too much debt. One idea…

Unmet Dental Needs and Barriers to Dental Care among Children with Autism Spectrum Disorders

ERIC Educational Resources Information Center

Lai, Bien; Milano, Michael; Roberts, Michael W.; Hooper, Stephen R.

2012-01-01

Mail-in pilot-tested questionnaires were sent to a stratified random sample of 1,500 families from the North Carolina Autism Registry. Multivariate logistic regression analysis was used to determine the significance of unmet dental needs and other predictors. Of 568 surveys returned (Response Rate = 38%), 555 were complete and usable. Sixty-five…

Nonword Repetition by Children with Cochlear Implants: Accuracy Ratings from Normal-Hearing Listeners.

ERIC Educational Resources Information Center

Dillon, Caitlin M.; Burkholder, Rose A.; Cleary, Miranda; Pisoni, David B.

2004-01-01

Seventy-six children with cochlear implants completed a nonword repetition task. The children were presented with 20 nonword auditory patterns over a loudspeaker and were asked to repeat them aloud to the experimenter. The children's responses were recorded on digital audiotape and then played back to normal-hearing adult listeners to obtain…

Needs and Concerns of Women in AACD: Preliminary Results.

ERIC Educational Resources Information Center

Thoreson, Richard W.; And Others

This study examined characteristics of female members of the American Association of Counseling and Development (AACD). A random sample of 1000 female members of AACD was surveyed, with a response rate of 12.1 percent of 121 surveys completed and returned. A questionnaire, the Female Counselor Survey, was developed to gather data on demographics,…

Juvenile Justice Teachers' Job Satisfaction: A Comparison of Teachers in Three States

ERIC Educational Resources Information Center

Houchins, David E.; Shippen, Margaret E.; McKeand, Kim; Viel-Ruma, Kim; Jolivete, Kristine; Guarino, Anthony J.

2010-01-01

The purpose of this study was to examine the differences in the perceptions of juvenile justice teachers in Georgia, Louisiana, and Ohio. Juvenile justice teachers (n = 542) completed an extensive attrition and retention survey with a 98% response rate. Comparisons were made between states, type of facility (short or long-term), gender, and…

Recovery Responses to Maximal Exercise in Healthy-Weight Children and Children with Obesity

ERIC Educational Resources Information Center

Easley, Elizabeth A.; Black, W. Scott; Bailey, Alison L.; Lennie, Terry A.; Sims, Wilma J.; Clasey, Jody L.

2018-01-01

Purpose: The purpose of this study was to examine differences in heart rate recovery (HRRec) and oxygen consumption recovery (VO2 recovery) between young healthy-weight children and children with obesity following a maximal volitional graded exercise test (GXTmax). Method: Twenty healthy-weight children and 13 children with obesity completed body…

A Comparison of Newly-Trained and Experienced Raters on a Standardized Writing Assessment

ERIC Educational Resources Information Center

Attali, Yigal

2016-01-01

A short training program for evaluating responses to an essay writing task consisted of scoring 20 training essays with immediate feedback about the correct score. The same scoring session also served as a certification test for trainees. Participants with little or no previous rating experience completed this session and 14 trainees who passed an…

Place attachment and recreation demand on the west branch of the Farmington River

Treesearch

Jordan W. Smith; Roger L. Moore

2012-01-01

This paper analyzes the effect of place attachment on recreation demand for theWest Branch of the Farmington River. Data were collected via on-site and optional mail-back questionnaires administered to river recreationists during the summer of 2001. A total of 247 respondents (51 percent response rate) returned complete questionnaires. Questions concerned respondents...

Student Satisfaction: The 2003 YESS Survey Results. Research Report.

ERIC Educational Resources Information Center

Howard Community Coll., Columbia, MD. Office of Planning and Evaluation.

This document is the annual student satisfaction survey completed by Howard Community College students in 2003.The respondents came from all different class sections. The survey was sent out to 2386 students and 1040 replied, which is a 44% response rate. The majority of respondents had chosen HCC due to its close proximity to home (37%) and their…

An Analysis of Persistence and Motivation in Public Research Institutions for Doctoral Completers

ERIC Educational Resources Information Center

Colbert, Marvette D.

2013-01-01

Doctoral student attrition is an issue of great concern among leaders in higher education (Gardner, 2009a). In response to concern for high attrition rates in doctoral programs, several studies (Lovitts, 2001; National Science Foundation, 2004; Nettles & Millett, 2006) investigated this issue aimed at gaining data to address this concern.…

Exploring Anomalies in Indigenous Student Engagement: Findings from a National Australian Survey of Undergraduates

ERIC Educational Resources Information Center

Asmar, Christine; Page, Susan; Radloff, Ali

2015-01-01

Increases in participation by Aboriginal and Torres Strait Islander students in higher education across Australia continue to be promising. However, it is also known that Indigenous students' attrition, retention and completion rates remain areas of concern. In this paper, we report our findings from an analysis of Indigenous student responses to…

Campus Climate Faculty/Staff/Administrator Survey. Institutional Research.

ERIC Educational Resources Information Center

Mattice, Nancy J.

In fall 1994, College of the Canyons (COC), in California, conducted a survey of all 380 faculty, staff, and administrators to determine their attitudes toward and experiences at the college. The survey rate was 31.8%, with 121 responses and results were compared to findings from a spring 1994 survey completed by 545 students for a 30.8% response…

Psychological stress during exercise: cardiorespiratory and hormonal responses.

PubMed

Webb, Heather E; Weldy, Michael L; Fabianke-Kadue, Emily C; Orndorff, G R; Kamimori, Gary H; Acevedo, Edmund O

2008-12-01

The purpose of this study was to examine the cardiorespiratory (CR) and stress hormone responses to a combined physical and mental stress. Eight participants (VO2(max) = 41.24 +/- 6.20 ml kg(-1) min(-1)) completed two experimental conditions, a treatment condition including a 37 min ride at 60% of VO2(max) with participants responding to a computerized mental challenge dual stress condition (DSC) and a control condition of the same duration and intensity without the mental challenge exercise alone condition (EAC). Significant interactions across time were found for CR responses, with heart rate, ventilation, and respiration rate demonstrating higher increases in the DSC. Additionally, norepinephrine was significantly greater in the DSC at the end of the combined challenge. Furthermore, cortisol area-under-the-curve (AUC) was also significantly elevated during the DSC. These results demonstrate that a mental challenge during exercise can exacerbate the stress response, including the release of hormones that have been linked to negative health consequences (cardiovascular, metabolic, autoimmune illnesses).

Physiological responses to the Coriolis illusion: effects of head position and vision.

PubMed

Westmoreland, David; Krell, Robert W; Self, Brian P

2007-10-01

Changes in sympathetic outflow during Type II spatial disorientation are well documented. In this study we investigated the influences of head position and eye state (open or closed) on sympathetic activation. There were 11 naive subjects (6 men, 5 women) who were tested in a General Aviation Trainer that accelerated at a subthreshold rate for 60 s until a constant angular velocity of 90 degrees x s(-1) was reached. Approximately 40 s later, subjects were instructed to tilt their heads along either the pitch or roll axis, stimulating a Coriolis illusion. Subjects reported the perceived intensity and duration of disorientation. Heart rate, heart rate variability, and electrodermal responses were recorded before, during, and after the period of disorientation. Each subject completed four trials, which were crossed combinations of head position and eye state. There were significant increases in heart rate and the electrodermal response during disorientation, but no significant change in heart rate variability. Head position had no significant effect on any physiological parameters or on the perceived intensity of disorientation; subjects reported a shorter duration of disorientation when the head was tilted into the roll versus the pitch axis. Eye state had no effect on heart rate, heart rate variability, or the intensity of disorientation, but the electrodermal response was somewhat greater, and the duration of disorientation shorter when eyes were open. The results suggest that head position and eye state (open or closed) do not need to be included as factors when investigating sympathetic outflow during a mild Coriolis illusion.

Chronotropic and pressor effects of water ingestion at rest and in response to incremental dynamic exercise.

PubMed

Mendonca, Goncalo V; Teixeira, Micael S; Heffernan, Kevin S; Fernhall, Bo

2013-06-01

Ingestion of water attenuates the chronotropic response to submaximal exercise. However, it is not known whether this effect is equally manifested during dynamic exercise below and above the ventilatory threshold (VT). We explored the effects of water ingestion on the heart rate response to an incremental cycle-ergometer protocol. In a randomized fashion, 19 healthy adults (10 men and nine women, age 20.9 ± 1.8 years) ingested 50 and 500 ml of water before completing a cycle-ergometer protocol on two separate days. The heart rate and oxygen uptake ( ) responses to water ingestion were analysed both at rest and during exercise performed below and above the VT. The effects of water intake on brachial blood pressure were measured only at rest. Resting mean arterial pressure increased and resting heart rate decreased, but only after 500 ml of water (P < 0.05). Compared with that seen after 50 ml of water, the 500 ml volume elicited an overall decrease in submaximal heart rate (P < 0.05). In contrast, drinking 500 ml of water did not affect submaximal . The participants' maximal heart rate, maximal and VT were similar between conditions. Our results therefore indicate that, owing to its effects on submaximal heart rate over a broad spectrum of intensities, the drinking of water should be recognized as a potential confounder in cardiovascular exercise studies. However, by showing no differences between conditions for submaximal , they also suggest that the magnitude of heart rate reduction after drinking 500 ml of water may be of minimal physiological significance for exercise cardiorespiratory capacity.

Plasmon-induced nonlinear response of silver atomic chains.

PubMed

Yan, Lei; Guan, Mengxue; Meng, Sheng

2018-05-10

Nonlinear response of a linear silver atomic chain upon ultrafast laser excitation has been studied in real time using the time-dependent density functional theory. We observe the presence of nonlinear responses up to the fifth order in tunneling current, which is ascribed to the excitation of high-energy electrons generated by Landau damping of plasmons. The nonlinear effect is enhanced after adsorption of polar molecules such as water due to the enhanced damping rates during plasmon decay. Increasing the length of atomic chains also increases the nonlinear response, favoring higher-order plasmon excitation. These findings offer new insights towards a complete understanding and ultimate control of plasmon-induced nonlinear phenomena to atomic precision.

Animal model of neuropathic tachycardia syndrome

NASA Technical Reports Server (NTRS)

Carson, R. P.; Appalsamy, M.; Diedrich, A.; Davis, T. L.; Robertson, D.

2001-01-01

Clinically relevant autonomic dysfunction can result from either complete or partial loss of sympathetic outflow to effector organs. Reported animal models of autonomic neuropathy have aimed to achieve complete lesions of sympathetic nerves, but incomplete lesions might be more relevant to certain clinical entities. We hypothesized that loss of sympathetic innervation would result in a predicted decrease in arterial pressure and a compensatory increase in heart rate. Increased heart rate due to loss of sympathetic innervation is seemingly paradoxical, but it provides a mechanistic explanation for clinical autonomic syndromes such as neuropathic postural tachycardia syndrome. Partially dysautonomic animals were generated by selectively lesioning postganglionic sympathetic neurons with 150 mg/kg 6-hydroxydopamine hydrobromide in male Sprague-Dawley rats. Blood pressure and heart rate were monitored using radiotelemetry. Systolic blood pressure decreased within hours postlesion (Delta>20 mm Hg). Within 4 days postlesion, heart rate rose and remained elevated above control levels. The severity of the lesion was determined functionally and pharmacologically by spectral analysis and responsiveness to tyramine. Low-frequency spectral power of systolic blood pressure was reduced postlesion and correlated with the diminished tyramine responsiveness (r=0.9572, P=0.0053). The tachycardia was abolished by treatment with the beta-antagonist propranolol, demonstrating that it was mediated by catecholamines acting on cardiac beta-receptors. Partial lesions of the autonomic nervous system have been hypothesized to underlie many disorders, including neuropathic postural tachycardia syndrome. This animal model may help us better understand the pathophysiology of autonomic dysfunction and lead to development of therapeutic interventions.

Chemical pleurodesis for malignant pleural effusions.

PubMed

Walker-Renard, P B; Vaughan, L M; Sahn, S A

1994-01-01

To provide information about available agents for chemical pleurodesis. A MEDLINE search (1966 to October 1992) was conducted using the terms malignant pleural effusion and pleurodesis. All articles containing references to patients with recurrent, symptomatic, malignant pleural effusions treated with chemical pleurodesis were selected and reviewed for pleurodesis regimen, number of patients treated, success rate (complete response), and adverse effects. The agents studied included doxycycline, minocycline, tetracycline, bleomycin, cisplatin, doxorubicin, etoposide, fluorouracil, interferon-beta, mitomycin-c, Corynebacterium parvum, methylprednisolone, and talc. Independent extraction by three observers. Studies including a total of 1168 patients with malignant pleural effusions were reviewed for efficacy of the pleurodesis agent and studies including 1140 patients were reviewed for toxicity. Chemical pleurodesis produced a complete response in 752 (64%) of 1168 patients. The success rate of the pleurodesis agents varied from 0% with etoposide to 93% with talc. Corynebacterium parvum, the tetracyclines, and bleomycin had success rates of 76%, 67%, and 54%, respectively. The most commonly reported adverse effects were pain (265 of 1140, 23%) and fever (220 of 1140, 19%). Doxycycline and minocycline, with success rates of 72% and 86%, respectively, appear to be effective tetracycline-replacement agents in the few patients studied. Talc appears to be the most effective and least expensive agent; however, insufflation has the disadvantages of the expense of thoracoscopy and the usual need for general anesthesia. Bleomycin appears to be less effective than talc and the tetracyclines and is substantially more expensive.

[Survey among readers of the Tijdschrift voor Psychiatrie].

PubMed

Brandt-Dominicus, J C; van Harten, P N

2006-01-01

The editorial board has defined the objectives of this journal as follows: to provide its readers with refreshing information, to report the results of scientific research and to build bridges between research and everyday practice. To find out what readers want and whether they support the board's objectives, and to use this information in planning the contents of future issues of the journal. All readers were invited to complete a questionnaire either on paper or via the website. Questionnaires were completed by 255 readers (response rate 5.7%). The average rating on a 5-point Likert scale was 3.8. Thematic issues and issues devoted to book reviews were given a high rating. There seems to be a demandfor evidence-based medicine, the inclusion of scientific results reported in other journals and practice-based articles. No significant differences were found between the views expressed by readers who had previously submitted an article for publication and those who had not, nor between Flemish readers and Dutch readers. The website was not visited very often. The Tijdschrift voor Psychiatrie is greatly appreciated by its readers. They are largely in agreement with the objectives formulated by the editorial board. Thematic issues are highly rated and many subjects are mentioned by the readers for future issues. The low response to the survey can affect its representativity. The editorial board will take readers' wishes into consideration when selecting material for future issues of the journal.

Potentially conflicting metabolic demands of diving and exercise in seals.

PubMed

Castellini, M A; Murphy, B J; Fedak, M; Ronald, K; Gofton, N; Hochachka, P W

1985-02-01

Metabolic replacement rates (Ra) for glucose and free fatty acids (FFA) were determined during rest, exercise, and diving conditions in the gray seal using bolus injections of radiotracers. In the exercise experiments the seal swam at a metabolic rate elevated twofold over resting Ra for glucose and FFA while resting were similar to values found in terrestrial mammals and other marine mammal species. During exercise periods glucose turnover increased slightly while FFA turnover changes were variable. However, the energetic demands of exercise could not be met by the increase in the replacement rates of glucose or FFA even if both were completely oxidized. Under diving conditions the tracer pool displayed radically different specific activity curves indicative of the changes in perfusion and metabolic rate associated with a strong dive response. Since the radiotracer curves during exercise and diving differed qualitatively and quantitatively, it is possible that similar studies on freely diving animals can be used to assess the role of the diving response during underwater swimming in nature.

A comparison between three electronic media and in-person learning for continuing education in physical rehabilitation.

PubMed

Lemaire, Edward; Greene, G

2003-01-01

We produced continuing education material in physical rehabilitation using a variety of electronic media. We compared four methods of delivering the learning modules: in person with a computer projector, desktop videoconferencing, Web pages and CD-ROM. Health-care workers at eight community hospitals and two nursing homes were asked to participate in the project. A total of 394 questionnaires were received for all modalities: 73 for in-person sessions, 50 for desktop conferencing, 227 for Web pages and 44 for CD-ROM. This represents a 100% response rate from the in-person, desktop conferencing and CD-ROM groups; the response rate for the Web group is unknown, since the questionnaires were completed online. Almost all participants found the modules to be helpful in their work. The CD-ROM group gave significantly higher ratings than the Web page group, although all four learning modalities received high ratings. A combination of all four modalities would be required to provide the best possible learning opportunity.

PRospective Imaging of CErvical cancer and neoadjuvant treatment (PRICE) study: role of ultrasound to predict partial response in locally advanced cervical cancer patients undergoing chemoradiation and radical surgery.

PubMed

Testa, A C; Ferrandina, G; Moro, F; Pasciuto, T; Moruzzi, M C; De Blasis, I; Mascilini, F; Foti, E; Autorino, R; Collarino, A; Gui, B; Zannoni, G F; Gambacorta, M A; Valentini, A L; Rufini, V; Scambia, G

2018-05-01

Chemoradiation-based neoadjuvant treatment followed by radical surgery is an alternative therapeutic strategy for locally advanced cervical cancer (LACC), but ultrasound variables used to predict partial response to neoadjuvant treatment are not well defined. Our goal was to analyze prospectively the potential role of transvaginal ultrasound in early prediction of partial pathological response, assessed in terms of residual disease at histology, in a large, single-institution series of LACC patients triaged to neoadjuvant treatment followed by radical surgery. Between October 2010 and June 2014, we screened 108 women with histologically documented LACC Stage IB2-IVA, of whom 88 were included in the final analysis. Tumor volume, three-dimensional (3D) power Doppler indices and contrast parameters were obtained before (baseline examination) and after 2 weeks of treatment. The pathological response was defined as complete (absence of any residual tumor after treatment) or partial (microscopic and/or macroscopic residual tumor at pathological examination). Complete-response and partial-response groups were compared and receiver-operating characteristics (ROC) curves were generated for ultrasound variables that were statistically significant on univariate analysis to evaluate their diagnostic ability to predict partial pathological response. There was a complete pathological response to neoadjuvant therapy in 40 (45.5%) patients and a partial response in 48 (54.5%). At baseline examination, tumor volume did not differ between the two groups. However, after 2 weeks of neoadjuvant treatment, the tumor volume was significantly greater in patients with partial response than it was in those with complete response (P = 0.019). Among the 3D vascular indices, the vascularization index (VI) was significantly lower in the partial-response compared with the complete-response group, both before and after 2 weeks of treatment (P = 0.037 and P = 0.024, respectively). At baseline examination in the contrast analysis, women with partial response had lower tumor peak enhancement (PE) as well as lower tumor wash-in rate (WiR) and longer tumor rise time (RT) compared with complete responders (P = 0.006, P = 0.003, P = 0.038, respectively). There was no difference in terms of contrast parameters after 2 weeks of treatment. ROC-curve analysis of baseline parameters showed that the best cut-offs for predicting partial pathological response were 41.5% for VI (sensitivity, 63.6%; specificity, 66.7%); 16123.5 auxiliary units for tumor PE (sensitivity, 47.9%; specificity, 84.2%); 7.8 s for tumor RT (sensitivity, 68.8%; specificity, 57.9%); and 4902 for tumor WiR (sensitivity, 77.1%; specificity, 60.5%). ROC curves of parameters after 2 weeks of treatment showed that the best cut-off for predicting partial pathological response was 18.1 cm 3 for tumor volume (sensitivity, 70.8%; specificity 60.0%) and 39.5% for VI (sensitivity; 62.5%; specificity, 73.5%). Ultrasound and contrast parameters differ between LACC patients with complete response and those with partial response before and after 2 weeks of neoadjuvant treatment. However, neither ultrasound parameters before treatment nor those after 2 weeks of treatment had cut-off values with acceptable sensitivity and specificity for predicting partial pathological response to neoadjuvant therapy. Copyright © 2017 ISUOG. Published by John Wiley & Sons Ltd. Copyright © 2017 ISUOG. Published by John Wiley & Sons Ltd.

Assessing the oral health of an ageing population: methods, challenges and predictors of survey participation.

PubMed

Matthews, Debora C; Brillant, Martha G S; Clovis, Joanne B; McNally, Mary E; Filiaggi, Mark J; Kotzer, Robert D; Lawrence, Herenia P

2012-06-01

To examine predictors of participation and to describe the methodological considerations of conducting a two-stage population-based oral health survey. An observational, cross-sectional survey (telephone interview and clinical oral examination) of community-dwelling adults aged 45-64 and ≥65 living in Nova Scotia, Canada was conducted. The survey response rate was 21% for the interview and 13.5% for the examination. A total of 1141 participants completed one or both components of the survey. Both age groups had higher levels of education than the target population; the age 45-64 sample also had a higher proportion of females and lower levels of employment than the target population. Completers (participants who completed interview and examination) were compared with partial completers (who completed only the interview), and stepwise logistic regression was performed to examine predictors of completion. Identified predictors were as follows: not working, post-secondary education and frequent dental visits. Recruitment, communications and logistics present challenges in conducting a province-wide survey. Identification of employment, education and dental visit frequency as predictors of survey participation provide insight into possible non-response bias and suggest potential for underestimation of oral disease prevalence in this and similar surveys. This potential must be considered in analysis and in future recruitment strategies. © 2011 The Gerodontology Society and John Wiley & Sons A/S.

Cumulative recruitment experience in two large single-center randomized, controlled clinical trials.

PubMed

Galbreath, Autumn Dawn; Smith, Brad; Wood, Pamela; Forkner, Emma; Peters, Jay I

2008-05-01

Trial recruitment is challenging for researchers, who frequently overestimate the pool of qualified, willing participants. Little has been written about recruitment and the comparative success of recruitment strategies. We describe one center's experience with recruitment in two regional single-center clinical trials with a combined total of 1971 participants. The heart failure trial was conducted between 1999 and 2003. The asthma trial was performed between 2003 and 2006. Trial databases were queried for referral source of each individual. Data were analyzed for effectiveness of referral source using three measures: percentage of enrollment due to that source, subject commitment to the trial (retention rate), and economics (cost per enrollee). 47.8% of CHF enrollees came from computer-generated lists or from healthcare provider referrals. Average marketing cost for enrollees and completers was $29.20 and $41.96 respectively. The most economical marketing strategy was self-referral in response to flyers. Most asthma participants (53.5%) were referred from healthcare providers, mailings to lists from local healthcare institutions, or self-referred in response to flyers. Average marketing cost for enrollees and completers was $20.44 and $38.10 respectively. The most economical marketing strategy was patient mailings. Retention rates were not markedly different among referral sources in either trial. In order to be considered effective, a recruitment strategy must demonstrate a balance between response to recruitment, retention rates, and economics. Despite the differences between these two clinical trials, the most effective recruitment strategies in both trials were mailings to locally-generated, targeted lists, and referrals from healthcare providers.

Comparison between Ultroid and rubber band ligation in treatment of internal hemorrhoids.

PubMed

Azizi, Rasoul; Rabani-Karizi, Behzad; Taghipour, Mohammad Ali

2010-01-01

Hemorrhoid is one of the most common surgical diseases and different methods are available for its treatment. This study is a comparison between two methods of treatment of internal hemorrhoid, Monopolar low voltage instrument (Ultroid) and Rubber Band Ligation. This method has been carried out prospectively in which 50 patients who were treated with rubber band ligation and 50 patients with Ultroid were compared according to the incidence of complications, post-operative pain and treatment response. According to this study complete success rate with Ultroid was 82% and partial success rate was 10% and no response to treatment was seen in 8%. In Rubber Band method the complete response rate was 94% (P=0.2). With Ultroid, 74% of patient reported no postoperative pain, 24% reported mild and moderate pain and 2% of patients complained of severe pain. With Rubber band ligation, 72% of patients reported no post-operative pain, 26% reported mild and moderate pain and 1% complained of severe pain (P=0.00). Rubber Band ligation and Ultroid are both considered as outpatient procedures for treatment of hemorrhoids. Both methods are mostly used for grade 1, 2 and sometime grade 3 hemorrhoids. In Ultroid method the operator is required to hold the probe for a period of time, and in most cases, the surgeon should spend between 20-25 minutes for the coagulation of three piles. Some surgeons do not have patience for this modality of internal hemorrhoid treatment. In this study we achieved acceptable results comparable with those of other techniques.

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

Mizumoto, Masashi; Department of Radiation Oncology, University of Tsukuba, Tsukuba, Ibaraki; Sugahara, Shinji

Purpose: To evaluate the efficacy and safety of hyperfractionated concomitant boost proton beam therapy (PBT) for patients with esophageal cancer. Methods and Materials: The study participants were 19 patients with esophageal cancer who were treated with hyperfractionated photon therapy and PBT between 1990 and 2007. The median total dose was 78 GyE (range, 70-83 GyE) over a median treatment period of 48 days (range, 38-53 days). Ten of the 19 patients were at clinical T Stage 3 or 4. Results: There were no cases in which treatment interruption was required because of radiation-induced esophagitis or hematologic toxicity. The overall 1-more » and 5-year actuarial survival rates for all 19 patients were 79.0% and 42.8%, respectively, and the median survival time was 31.5 months (95% limits: 16.7- 46.3 months). Of the 19 patients, 17 (89%) showed a complete response within 4 months after completing treatment and 2 (11%) showed a partial response, giving a response rate of 100% (19/19). The 1- and 5-year local control rates for all 19 patients were 93.8% and 84.4 %, respectively. Only 1 patient had late esophageal toxicity of Grade 3 at 6 months after hyperfractionated PBT. There were no other nonhematologic toxicities, including no cases of radiation pneumonia or cardiac failure of Grade 3 or higher. Conclusions: The results suggest that hyperfractionated PBT is safe and effective for patients with esophageal cancer. Further studies are needed to establish the appropriate role and treatment schedule for use of PBT for esophageal cancer.« less

Strategies to Maximize Data Collection Response Rates in a Randomized Control Trial Focused on Children with Medical Complexity.

PubMed

Finkelstein, Stanley M; Celebrezze, Margaret; Cady, Rhonda; Lunos, Scott; Looman, Wendy S

2016-04-01

Obtaining complete and timely subject data is key to the success of clinical trials, particularly for studies requiring data collected from subjects at home or other remote sites. A multifaceted strategy for data collection in a randomized controlled trial (RCT) focused on care coordination for children with medical complexity is described. The influences of data collection mode, incentives, and study group membership on subject response patterns are analyzed. Data collection included monthly healthcare service utilization (HCSU) calendars and annual surveys focused on care coordination outcomes. One hundred sixty-three families were enrolled in the 30-month TeleFamilies RCT. Subjects were 2-15 years of age at enrollment. HCSU data were collected by parent/guardian self-report using mail, e-mail, telephone, or texting. Surveys were collected by mail. Incentives were provided for completed surveys after 8 months to improve collection returns. Outcome measures were the number of HCSU calendars and surveys returned, the return interval, data collection mode, and incentive impact. Return rates of 90% for HCSU calendars and 82% for annual surveys were achieved. Mean return intervals were 72 and 65 days for HCSU and surveys, respectively. Survey response increased from 55% to 95% after introduction of a gift card and added research staff. High return rates for HCSU calendars and health-related surveys are attainable but required a flexible and personnel-intensive approach to collection methods. Family preference for data collection approach should be obtained at enrollment, should be modified as needed, and requires flexible options, training, intensive staff/family interaction, and patience.

Participant recruitment to FiCTION, a primary dental care trial - survey of facilitators and barriers.

PubMed

Keightley, A; Clarkson, J; Maguire, A; Speed, C; Innes, N

2014-11-01

To identify reasons behind a lower than expected participant recruitment rate within the FiCTION trial, a multi-centre paediatric primary dental care randomised controlled trial (RCT). An online survey, based on a previously published tool, consisting of both quantitative and qualitative responses, completed by staff in dental practices recruiting to FiCTION. Ratings from quantitative responses were aggregated to give overall scores for factors related to participant recruitment. Qualitative responses were independently grouped into themes. Thirty-nine anonymous responses were received. Main facilitators related to the support received from the central research team and importance of the research question. The main barriers related to low child eligibility rates and the integration of trial processes within routine workloads. These findings have directed strategies for enhancing participant recruitment at existing practices and informed recruitment of further practices. The results help provide a profile of the features required of practices to successfully screen and recruit participants. Future trials in this setting should consider the level of interest in the research question within practices, and ensure trial processes are as streamlined as possible. Research teams should actively support practices with participant recruitment and maintain enthusiasm among the entire practice team.

Quantifying the Physiological Stress Response to Simulated Maritime Pilotage Tasks

PubMed Central

Main, Luana C.; Wolkow, Alexander; Chambers, Timothy P.

2017-01-01

Objective: The aim of this study was to quantify the stress associated with performing maritime pilotage tasks in a high-fidelity simulator. Methods: Eight trainee and 13 maritime pilots completed two simulated pilotage tasks of varying complexity. Salivary cortisol samples were collected pre- and post-simulation for both trials. Heart rate was measured continuously throughout the study. Results: Significant changes in salivary cortisol (P = 0.000, η2 = 0.139), average (P = 0.006, η2 = 0.087), and peak heart rate (P = 0.013, η2 = 0.077) from pre- to postsimulation were found. Varying task complexity did partially influence stress response; average (P = 0.016, η2 = 0.026) and peak heart rate (P = 0.034, η2 = 0.020) were higher in the experimental condition. Trainees also recorded higher average (P = 0.000, η2 = 0.054) and peak heart rates (P = 0.027, η2 = 0.022). Conclusion: Performing simulated pilotage tasks evoked a measurable stress response in both trainee and expert maritime pilots. PMID:28922309

Comparison of Online Survey Recruitment Platforms for Hard-to-Reach Pregnant Smoking Populations: Feasibility Study.

PubMed

Ibarra, Jose Luis; Agas, Jessica Marie; Lee, Melissa; Pan, Julia Lily; Buttenheim, Alison Meredith

2018-04-16

Recruiting hard-to-reach populations for health research is challenging. Web-based platforms offer one way to recruit specific samples for research purposes, but little is known about the feasibility of online recruitment and the representativeness and comparability of samples recruited through different Web-based platforms. The objectives of this study were to determine the feasibility of recruiting a hard-to-reach population (pregnant smokers) using 4 different Web-based platforms and to compare participants recruited through each platform. A screener and survey were distributed online through Qualtrics Panel, Soapbox Sample, Reddit, and Amazon Mechanical Turk (mTurk). Descriptive statistics were used to summarize results of each recruitment platform, including eligibility yield, quality yield, income, race, age, and gestational age. Of the 3847 participants screened for eligibility across all 4 Web-based platforms, 535 were eligible and 308 completed the survey. Amazon mTurk yielded the fewest completed responses (n=9), 100% (9/9) of which passed several quality metrics verifying pregnancy and smoking status. Qualtrics Panel yielded 14 completed responses, 86% (12/14) of which passed the quality screening. Soapbox Sample produced 107 completed surveys, 67% (72/107) of which were found to be quality responses. Advertising through Reddit produced the highest completion rate (n=178), but only 29.2% (52/178) of those surveys passed the quality metrics. We found significant differences in eligibility yield, quality yield, age, number of previous pregnancies, age of smoking initiation, current smokers, race, education, and income (P<.001). Although each platform successfully recruited pregnant smokers, results varied in quality, cost, and percentage of complete responses. Moving forward, investigators should pay careful attention to the percentage yield and cost of online recruitment platforms to maximize internal and external validity. ©Jose Luis Ibarra, Jessica Marie Agas, Melissa Lee, Julia Lily Pan, Alison Meredith Buttenheim. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 16.04.2018.

Hematopoietic responses under protracted exposures to low daily dose gamma irradiation

NASA Astrophysics Data System (ADS)

Seed, T. M.; Fritz, T. E.; Tolle, D. V.; Jackson, W. E.

In attempting to evaluate the possible health consequences of chronic ionizing radiation exposure during extended space travel (e.g., Mars Mission), ground-based experimental studies of the clinical and pathological responses of canines under low daily doses of 60Co gamma irradiation (0.3-26.3 cGy d -1) have been examined. Specific reference was given to responses of the blood forming system. Results suggest that the daily dose rate of 7.5 cGy d -1 represents a threshold below which the hematopoietic system can retain either partial or full trilineal cell-producing capacity (erythropoiesis, myelopoiesis, and megakaryopoiesis) for extended periods of exposure (> 1yr). Trilineal capacity was fully retained for several years of exposure at the lowest dose-rate tested (0.3 cGy d -1) but was completely lost within several hundred days at the highest dose-rate (26.3 cGy d -1). Retention of hematopoietic capacity under chronic exposure has been demonstrated to be mediated by hematopoietic progenitors with acquired radioresistance and repair functions, altered cytogenetics, and cell-cycle characteristics. Radiological, biological, and temporal parameters responsible for these vital acquisitions by hematopoietic progenitors have been partially characterized. These parameters, along with threshold responses, are described and discussed in relation to potential health risks of the space traveler under chronic stress of low-dose irradiation.

A phase II trial of fixed-dosed rate gemcitabine in platinum-resistant ovarian cancer: a GEICO (Grupo Español de Investigación en Cáncer de Ovario) Trial.

PubMed

Ojeda Gonzalez, Belen; Gonzalez Martin, Antonio; Bover Barcelo, Isabel; Fabregat i Mayol, Xavier; Mellado, Begoña; Rubio Perez, María Jesus; Alonso Carrion, Lorenzo; Casado Herraez, Antonio; Calvo Garcia, Elisa; Churruca Galaz, Cristina; Arcusa Lanza, Angels; Herrero Ibañez, Ana; Adrover Cebrian, Encarna; Poveda Velasco, Andres

2008-10-01

Gemcitabine has well-recognized activity in the treatment of ovarian cancer. Fixed-dose rate (FDR) delivery has been proposed as a more rationale way to administer gemcitabine, to avoid saturation of the enzyme that catalyzes its intracellular transformation into the active metabolites, difluorodeoxycitidine biphosphate, and triphosphate. Our aim was to assess clinical activity of gemcitabine delivered by FDR infusion in patients with platinum resistant ovarian cancer. Patients with platinum-resistant ovarian cancer received gemcitabine 1000 mg/m(2) over 120 minutes on days 1 and 8 of each cycle. Cycles were repeated every 3 weeks, and up to 6 cycles were delivered. Forty-eight patients were included in the study. Among 41 patients evaluable for response, 9 clinical responses (1 complete response and 8 partial responses) were observed, achieving a global response rate of 22%. Grade 3 to 4 hematological toxicity consisted of anemia (15% of patients), neutropenia (24%), and thrombopenia (10%). One patient died due to septic shock. The main grade 3 to 4 nonhematological toxicity was asthenia (7 patients, 17%). Activity of gemcitabine administered by FDR infusion in patients with platinum-resistant ovarian cancer seems similar to that achieved using 30-minute infusions, with higher toxicity.

Age-related change in fast adaptation mechanisms measured with the scotopic full-field ERG.

PubMed

Tillman, Megan A; Panorgias, Athanasios; Werner, John S

2016-06-01

To quantify the response dynamics of fast adaptation mechanisms of the scotopic ERG in younger and older adults using full-field m-sequence flash stimulation. Scotopic ERGs were measured for a series of flashes separated by 65 ms over a range of 260 ms in 16 younger (20-26, 22.2 ± 2.1; range mean ±1 SD) and 16 older (65-85, 71.2 ± 7) observers without retinal pathology. A short-wavelength (λ peak = 442 nm) LED was used for scotopic stimulation, and the flashes ranged from 0.0001 to 0.01 cd s m(-2). The complete binary kernel series was derived from the responses to the m-sequence flash stimulation, and the first- and second-order kernel responses were analyzed. The first-order kernel represented the response to a single, isolated flash, while the second-order kernels reflected the adapted flash responses that followed a single flash by one or more base intervals. B-wave amplitudes of the adapted flash responses were measured and plotted as a function of interstimulus interval to describe the recovery of the scotopic ERG. A linear function was fitted to the linear portion of the recovery curve, and the slope of the line was used to estimate the rate of fast adaptation recovery. The amplitudes of the isolated flash responses and rates of scotopic fast adaptation recovery were compared between the younger and older participants using a two-way ANOVA. The isolated flash responses and rates of recovery were found to be significantly lower in the older adults. However, there was no difference between the two age groups in response amplitude or recovery rate after correcting for age-related changes in the density of the ocular media. These results demonstrated that the rate of scotopic fast adaptation recovery of normal younger and older adults is similar when stimuli are equated for retinal illuminance.

Retrospective analysis for treatment of naïve canine multicentric lymphoma with a 15-week, maintenance-free CHOP protocol.

PubMed

Curran, K; Thamm, D H

2016-08-01

Standard of care treatment of dogs with multicentric lymphoma includes combination chemotherapy with cyclophosphamide, doxorubicin, vincristine and prednisone (CHOP); however, owners may be hesitant to commit the resources necessary to complete a lengthy, multi-drug protocol. One hundred thirty-four client-owned dogs with multicentric lymphoma were treated with a 15-week CHOP chemotherapy protocol. The overall response rate was 98% with 104 dogs experiencing a complete response (CR). The median progression-free survival (PFS) time for all dogs was 176 days, and the median disease-specific overall survival time was 311 days. Prognostic factors identified on multivariate analysis as significant for PFS included substage, immunophenotype, hospitalization for adverse events, need for dose reduction, presence of neutrophilia at diagnosis, presence of anemia and experiencing a CR as best response to therapy. In conclusion, this protocol may be a viable alternative to CHOP protocols using a larger number of treatments. © 2015 John Wiley & Sons Ltd.

Axisymmetric micromechanics of elastic-perfectly plastic fibrous composites under uniaxial tension loading

NASA Technical Reports Server (NTRS)

Lee, Jong-Won; Allen, David H.

1993-01-01

The uniaxial response of a continuous fiber elastic-perfectly plastic composite is modeled herein as a two-element composite cylinder. An axisymmetric analytical micromechanics solution is obtained for the rate-independent elastic-plastic response of the two-element composite cylinder subjected to tensile loading in the fiber direction for the case wherein the core fiber is assumed to be a transversely isotropic elastic-plastic material obeying the Tsai-Hill yield criterion, with yielding simulating fiber failure. The matrix is assumed to be an isotropic elastic-plastic material obeying the Tresca yield criterion. It is found that there are three different circumstances that depend on the fiber and matrix properties: fiber yield, followed by matrix yielding; complete matrix yield, followed by fiber yielding; and partial matrix yield, followed by fiber yielding, followed by complete matrix yield. The order in which these phenomena occur is shown to have a pronounced effect on the predicted uniaxial effective composite response.

A comprehensive curriculum for thoracic surgery: survey of opinions from program directors and residents.

PubMed

Murray, G F; Jones, D R; Stritter, F T

1995-10-01

The Comprehensive Thoracic Surgery Curriculum was developed to provide program directors with a basis for planning instruction and evaluating residents, program practices, and outcomes. A survey design was selected to obtain opinions about the curriculum from a large group of people, ie, all program directors and all active residents. Two parallel instruments were developed: one to be completed by program directors and one to be completed by active residents. Responses were collated for directors and residents, entered into a computerized database, and compared using the chi 2 statistic. A response rate of 93% was obtained from the directors and 79% from the residents. The survey demonstrates broad-based support for a comprehensive curriculum by the respondents. Current perceptions of and expectations for the curriculum are diverse and regionalized. Serious concerns are expressed about quality issues and particularly the environment for residency education. The thoughtful responses of our colleagues will guide leaders who will implement the curriculum for thoracic surgery. Strategies for change will necessarily focus on the prerequisite curriculum.

Directional control-response compatibility relationships assessed by physical simulation of an underground bolting machine.

PubMed

Steiner, Lisa; Burgess-Limerick, Robin; Porter, William

2014-03-01

The authors examine the pattern of direction errors made during the manipulation of a physical simulation of an underground coal mine bolting machine to assess the directional control-response compatibility relationships associated with the device and to compare these results to data obtained from a virtual simulation of a generic device. Directional errors during the manual control of underground coal roof bolting equipment are associated with serious injuries. Directional control-response relationships have previously been examined using a virtual simulation of a generic device; however, the applicability of these results to a specific physical device may be questioned. Forty-eight participants randomly assigned to different directional control-response relationships manipulated horizontal or vertical control levers to move a simulated bolter arm in three directions (elevation, slew, and sump) as well as to cause a light to become illuminated and raise or lower a stabilizing jack. Directional errors were recorded during the completion of 240 trials by each participant Directional error rates are increased when the control and response are in opposite directions or if the direction of the control and response are perpendicular.The pattern of direction error rates was consistent with experiments obtained from a generic device in a virtual environment. Error rates are increased by incompatible directional control-response relationships. Ensuring that the design of equipment controls maintains compatible directional control-response relationships has potential to reduce the errors made in high-risk situations, such as underground coal mining.

Treatment of hidradenitis suppurativa with intralesional photodynamic therapy with 5-aminolevulinic acid and 630nm laser beam.

PubMed

Suárez Valladares, María Jesús; Eiris Salvado, Noemi; Rodríguez Prieto, Manuel Angel

2017-03-01

Hidradenitis suppurativa (HS) is a chronic relapsing inflammatory skin disease with multiple treatment options that have been used with mixed results. To evaluate the effectiveness, safety and tolerability of intralesional photodynamic therapy (I-PDT) in the management of HS. Also, to assess the effect of this technique on the different areas treated. Case series of 38 HS patients treated with I-PDT between 2011-2015 following a standardized protocol to assess response at the treated areas RESULTS: 29 patients achieved a complete response, while persistence was noted on 8 cases and only 1 suffered a recurrence. Difference between basal (median 28.5) and final (0) Hidradenitis Severity Score showed a significant reduction of 24.5 points (p<0.001, 95% OR 19.5-31). Basal (median 10) and final (1) Dermatology Life Quality Index scores reached a reduction of 10 points (p<0.001, 95%OR 8-12). Complete response was achieved in 68.2% of armpits, 88.5% of groins, 88.9% of buttocks and 100% of other locations. 18 out of 38 patients needed only a session to achieve a complete response, while maintaining a good tolerability. We believe that I-PDT might be an alternative treatment option for localized HS lesions, achieving a high rate of remission with an adequate maintenance of response i and few complications. Copyright © 2016 Japanese Society for Investigative Dermatology. Published by Elsevier B.V. All rights reserved.

Caffeine alters emotion and emotional responses in low habitual caffeine consumers.

PubMed

Giles, Grace E; Spring, Alexander M; Urry, Heather L; Moran, Joseph M; Mahoney, Caroline R; Kanarek, Robin B

2018-02-01

Caffeine reliably increases emotional arousal, but it is unclear whether and how it influences other dimensions of emotion such as emotional valence. These experiments documented whether caffeine influences emotion and emotion regulation choice and success. Low to abstinent caffeine consumers (maximum 100 mg/day) completed measures of state anxiety, positive and negative emotion, and salivary cortisol before, 45 min after, and 75 min after consuming 400 mg caffeine or placebo. Participants also completed an emotion regulation choice task, in which they chose to employ cognitive reappraisal or distraction in response to high and low intensity negative pictures (Experiment 1), or a cognitive reappraisal task, in which they employed cognitive reappraisal or no emotion regulation strategy in response to negative and neutral pictures (Experiment 2). State anxiety, negative emotion, and salivary cortisol were heightened both 45 and 75 min after caffeine intake relative to placebo. In Experiment 1, caffeine did not influence the frequency with which participants chose reappraisal or distraction, but reduced negativity of the picture ratings. In Experiment 2, caffeine did not influence cognitive reappraisal success. Thus, caffeine mitigated emotional responses to negative situations, but not how participants chose to regulate such responses or the success with which they did so.

Initial clinical outcomes of proton beam radiotherapy for hepatocellular carcinoma.

PubMed

Yu, Jeong Il; Yoo, Gyu Sang; Cho, Sungkoo; Jung, Sang Hoon; Han, Youngyih; Park, Seyjoon; Lee, Boram; Kang, Wonseok; Sinn, Dong Hyun; Paik, Yong-Han; Gwak, Geum-Youn; Choi, Moon Seok; Lee, Joon Hyeok; Koh, Kwang Cheol; Paik, Seung Woon; Park, Hee Chul

2018-03-01

This study aimed to evaluate the initial outcomes of proton beam therapy (PBT) for hepatocellular carcinoma (HCC) in terms of tumor response and safety. HCC patients who were not indicated for standard curative local modalities and who were treated with PBT at Samsung Medical Center from January 2016 to February 2017 were enrolled. Toxicity was scored using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. Tumor response was evaluated using modified Response Evaluation Criteria in Solid Tumors (mRECIST). A total of 101 HCC patients treated with PBT were included. Patients were treated with an equivalent dose of 62-92 GyE 10 . Liver function status was not significantly affected after PBT. Greater than 80% of patients had Child-Pugh class A and albumin-bilirubin (ALBI) grade 1 up to 3-months after PBT. Of 78 patients followed for three months after PBT, infield complete and partial responses were achieved in 54 (69.2%) and 14 (17.9%) patients, respectively. PBT treatment of HCC patients showed a favorable infield complete response rate of 69.2% with acceptable acute toxicity. An additional follow-up study of these patients will be conducted.

Initial clinical outcomes of proton beam radiotherapy for hepatocellular carcinoma

PubMed Central

Yu, Jeong Il; Yoo, Gyu Sang; Cho, Sungkoo; Jung, Sang Hoon; Han, Youngyih; Park, Seyjoon; Lee, Boram; Kang, Wonseok; Sinn, Dong Hyun; Paik, Yong-Han; Gwak, Geum-Youn; Choi, Moon Seok; Lee, Joon Hyeok; Koh, Kwang Cheol; Paik, Seung Woon; Park, Hee Chul

2018-01-01

Purpose This study aimed to evaluate the initial outcomes of proton beam therapy (PBT) for hepatocellular carcinoma (HCC) in terms of tumor response and safety. Materials and Methods HCC patients who were not indicated for standard curative local modalities and who were treated with PBT at Samsung Medical Center from January 2016 to February 2017 were enrolled. Toxicity was scored using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. Tumor response was evaluated using modified Response Evaluation Criteria in Solid Tumors (mRECIST). Results A total of 101 HCC patients treated with PBT were included. Patients were treated with an equivalent dose of 62–92 GyE10. Liver function status was not significantly affected after PBT. Greater than 80% of patients had Child-Pugh class A and albumin-bilirubin (ALBI) grade 1 up to 3-months after PBT. Of 78 patients followed for three months after PBT, infield complete and partial responses were achieved in 54 (69.2%) and 14 (17.9%) patients, respectively. Conclusion PBT treatment of HCC patients showed a favorable infield complete response rate of 69.2% with acceptable acute toxicity. An additional follow-up study of these patients will be conducted. PMID:29580046