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Group Study (group + study)

Distribution by Scientific Domains
Medical Sciences92%
2 Other Domains8%

Kinds of Group Study

  • focus group study
    		•
  • oncology group study
    		•
  • parallel group study
    		•

    Selected Abstracts

    CHALLENGES FACED BY RESEARCH ETHICS COMMITTEES IN EL SALVADOR: RESULTS FROM A FOCUS GROUP STUDY

    DEVELOPING WORLD BIOETHICS, Issue 1 2009
    JONATHAN W. CAMP
    ABSTRACT Objective:, To identify perceived barriers to capacity building for local research ethics oversight in El Salvador, and to set an agenda for international collaborative capacity building. Methods:, Focus groups were formed in El Salvador which included 17 local clinical investigators and members of newly formed research ethics committees. Information about the proposed research was presented to participants during an international bioethics colloquium sponsored and organized by the St. Jude Children's Research Hospital in collaboration with the National Ethics Committee of El Salvador and the University of El Salvador. Interviews with the focus group participants were qualitatively analyzed. Results:, Participants expressed the need to tailor the informed consent process and documentation to the local culture; for example, allowing family members to participate in decision-making, and employing shorter consent forms. Participants indicated that economic barriers often impede efforts in local capacity building. Participants valued international collaboration for mutual capacity building in research ethics oversight. Conclusions:, Research ethics committees in El Salvador possess a basic knowledge of locally relevant ethical principles, though they need more training to optimize the application of bioethical principles and models to their particular contexts. Challenges increase the value of collaborative exchanges with ethics committee members in the United States. Further research on facilitating communication between host country and sponsor country ethics committees can maximize local research ethics expertise, and thus raise the standard of protecting human participants involved in international research. [source]

    A PILOT STUDY OF PREOPERATIVE AND POSTOPERATIVE CHEMOTHERAPY IN PATIENTS WITH OPERABLE GASTRIC CANCER: AUSTRALASIAN GASTROINTESTINAL TRIALS GROUP STUDY 9601

    ANZ JOURNAL OF SURGERY, Issue 4 2007
    Michael Findlay
    Background: With poor cure rates in gastric cancer using surgery alone, the safety, efficacy and feasibility of preoperative and postoperative chemotherapy was investigated. Methods: Patients with advanced but operable gastric or cardio-oesophageal adenocarcinoma were staged using endoscopy, computed tomography scan and laparoscopy. If considered potentially resectable, they received chemotherapy (epirubicin, cisplatin and 5-fluorouracil) for 9 weeks before and after surgery. Results: Of 59 participants entered, two were found to have metastatic disease and were excluded from the analysis. Of the participants, 10 were women and 47 men; their median age was 58 years (range 27,83 years) and median performance status 0 (range 0,1). Two of the 57 participants commencing chemotherapy did not undergo surgery (one sudden death, one new liver metastases). Grade 3 and 4 preoperative and postoperative toxicity rates were, respectively, neutropenia 22 and 18%, emesis 12 and 14% and other non-haematological toxicity <10 and <10%. Of the 55 who underwent surgery, 40 had apparently curative resections (clear or positive microscopic margins), 2 died after surgery (anastomotic leak, sepsis) and 16 had postoperative complications. Of these, 27 participants commenced postoperative chemotherapy and 21 completed it. Median progression-free survival and overall survival were 19.6 and 22 months, respectively. Conclusion: Epirubicin, cisplatin and protracted venous infusion of 5-fluorouracil chemotherapy was well-tolerated in the preoperative setting and did not appear to increase complication rates of surgery for advanced and operable stomach cancer. These findings demonstrate the feasibility of this strategy in the Australasian clinical setting and are in keeping with the results of a recently reported randomized trial, which demonstrated a significant survival advantage using this chemotherapy regimen. [source]

    Service User Outcomes of Staff Training in Positive Behaviour Support Using Person-Focused Training: A Control Group Study

    JOURNAL OF APPLIED RESEARCH IN INTELLECTUAL DISABILITIES, Issue 1 2007
    Ian M. Grey
    Background, Effectively supporting individuals with intellectual disabilities who display challenging behaviours continues to be a priority for service providers. Person-focused training (PFT) is a model of service delivery which provides staff with skills in functional assessment and intervention development. Existing longitudinal data from a study of 138 cases suggest that implementation of staff-developed behaviour support plans through PFT is effective in reducing challenging behaviour in approximately 77% of cases [McClean et al.Journal of Intellectual Disability Research (2005) vol. 49, pp. 340,353]. However, no control group was used in this study. Method, The current study involves the use of a control group of individuals with challenging behaviours matched against those selected for PFT over a 6-month period. Groups were matched on type of challenging behaviour, duration of challenging behaviour, gender and level of disability. Information on the frequency, management difficulty and severity of challenging behaviour was collected pre- and post-training using the Checklist of Challenging Behaviours (CCB) for both groups. Observational data were collected for the target group alone. Rates of psychotropic medication were tracked across the training period. Results, Significant reductions in the frequency, management difficulty and severity of challenging behaviour were found for service users in the target group but not in the control group after 6 months. No significant changes were found in the use of psychotropic medication for either group over the 6-month period. Conclusion, Overall results suggest that PFT is an effective model for providing support to individuals with challenging behaviours. [source]

    Phase I Clinical Evaluation of Carboplatin in Tumor-Bearing Cats: A Veterinary Cooperative Oncology Group Study

    JOURNAL OF VETERINARY INTERNAL MEDICINE, Issue 1 2008
    W.C. Kisseberth
    Background: The dosage of carboplatin in cats has been reported anecdotally and experimentally in non-tumor-bearing cats, but the dosage for carboplatin treatment in tumor-bearing cats has yet to be defined in a prospective clinical trial. Purpose: To determine the maximally tolerated dose (MTD) and dose-limiting toxicosis (DLT) of carboplatin in tumor-bearing cats. Cats: Fifty-nine cats with measurable solid tumors. Methods: The starting dose of carboplatin was 160 mg/m2 of body surface area IV. Doses were increased by 20 mg/m2 in cohorts of 3,14 cats until the MTD was reached. Results: The 59 cats entered into this multi-institutional phase I study received 1 or more doses of carboplatin at various dosages and were evaluated for toxicity, response to treatment, or both. The MTD was 240 mg/m2 and neutropenia was the DLT. For the 1st cycle of treatment in 44 cats evaluated for neutropenia, 6 episodes of grade 3 or greater neutropenia occurred on days 7 (n=1), 14 (n=4), and 21 (n=1). There was no evidence of drug-induced nephrotoxicosis or pulmonary edema. Preliminary evidence of antitumor activity was observed in 7 of 59 (11.9%; 95% CI, 5.6,22.8%) cats evaluated for response to treatment. There was 1 complete response (cutaneous hemangiosarcoma) and 6 partial responses (4 injection site sarcomas, 1 oral squamous cell carcinoma, 1 lymphoma). Responses were of short duration (median, 42 days; range, 7,168 days). Conclusions and Clinical Importance: The dose of carboplatin recommended to treat tumor-bearing cats is 240 mg/m2 IV every 3,4 weeks. [source]

    A phase 2 trial of all- trans -retinoic acid in combination with interferon-,2a in children with recurrent neuroblastoma or Wilms tumor: A Pediatric Oncology Branch, NCI and Children's Oncology Group Study

    PEDIATRIC BLOOD & CANCER, Issue 5 2007
    Peter C. Adamson MD
    Abstract Background The combination of the antiproliferative and differentiation-inducing effects of retinoids together with the antiproliferative, immunostimulatory, and differentiation-potentiating effects of interferon-, (IFN-,) were the basis for the development of this combination in pediatric patients with refractory neuroblastoma or Wilms tumor. Procedure A phase 2 trial of all- trans -retinoic acid (ATRA), administered orally at a dose of 90 mg/m2/day in three divided doses for 3 consecutive days per week, and IFN-,2a, administered subcutaneously daily at a dose of 3,×,106 U/m2/day for 5 consecutive days per week, in 4 week cycles was performed. A two-stage design was used for each disease stratum. Results Seventeen patients (16 evaluable) with neuroblastoma, median age 9 years, and 15 patients (14 evaluable) with Wilms tumor, median age 6 years, were enrolled. Overall, the combination was well tolerated, with headache being the most common toxicity observed. There were no complete or partial responses. The median number of cycles administered was 1 (range 1,9). Four patients with neuroblastoma had stable disease for 12 or more weeks. Conclusions The combination of ATRA and IFN-,2a was inactive in children with relapsed or refractory neuroblastoma and Wilms tumor. The lack of activity with this combination in children with refractory neuroblastoma is similar to the disappointing phase 2 results of single agent 13- cis -retinoic-acid (13cRA) and does not support further development of ATRA for children with relapsed neuroblastoma. Pediatr Blood Cancer 2007;49:661,665. © 2006 Wiley-Liss, Inc. [source]

    Infant leukemia and congenital abnormalities: A Children's Oncology Group study,

    PEDIATRIC BLOOD & CANCER, Issue 1 2010
    Kimberly J. Johnson PhD
    Abstract Background Leukemia in infants is rare and has not been well studied apart from leukemia in older children. Differences in survival and the molecular characteristics of leukemia in infants versus older children suggest a distinct etiology, likely involving prenatal factors. Procedure We examined the association between eight categories of maternally reported congenital abnormalities (CAs) (cleft lip or palate, spina bifida or other spinal defect, large or multiple birthmarks, other chromosomal abnormalities, small head or microcephaly, rib abnormalities, urogenital abnormalities, and other) and infant leukemia in a case,control study. The study included 443 cases diagnosed at <1 year of age at a Children's Oncology Group Institution in the United States or Canada from 1996 to 2006 and 324 controls. Controls were recruited from the cases' geographic area either by random digit dialing (1999,2002) or through birth certificates (2003,2008) and were frequency-matched to cases on birth year. Odds ratios (ORs) and 95% confidence intervals (CIs) were calculated by unconditional logistic regression after adjustment for birth year and a measure of follow-up time to account for differences in the CA observation period. Results No statistically significant associations were observed between infant leukemia and any CA (OR,=,1.2; 95% CI: 0.8,1.9), birthmarks (OR,=,1.4; 95% CI: 0.7,2.5), urogenital abnormalities (OR,=,0.7; 95% CI: 0.2,2.0), or other CA (OR,=,1.4; 95% CI: 0.7,2.8). Results were similar for acute lymphoblastic and myeloid leukemia cases. Fewer than five subjects were in the remaining CA categories precluding analysis. Conclusions Overall, we did not find evidence to support an association between CAs and infant leukemia. Pediatr Blood Cancer 2010;55:95,99. © 2010 Wiley-Liss, Inc. [source]

    Phase I study of paclitaxel with standard dose ifosfamide in children with refractory solid tumors: A Pediatric Oncology Group study (POG 9376)

    PEDIATRIC BLOOD & CANCER, Issue 3 2009
    James I. Geller MD
    Abstract Purpose A dose-escalation Phase I study of taxol (paclitaxel) administered in combination with standard dose ifosfamide was conducted in children with relapsed or refractory solid tumors. Primary objectives were to estimate the maximum tolerated dose (MTD) and to describe the dose-limiting toxicities (DLTs). Patients and Methods Paclitaxel was administered as a 6-hr continuous infusion (hr 0,6), followed by intravenous ifosfamide (2 g/m2/day,×,3 days) over 1 hr at hours 6,7, 24,25, and 48,49. Patients at dose level 1 received 250 mg/m2 paclitaxel. Subsequent dose escalation proceeded using a standard 3,×,3 Phase I design. Results Fifteen patients received a combined 46 courses of therapy. The median age was 14.5 years (range, 2,19 years), and diagnoses included sarcoma (7), neuroblastoma (3), and other (5). Three patients received paclitaxel at 250 mg/m2 (10 courses), six at 325 mg/m2 (19 courses), three at 425 mg/m2 (8 courses), and three at 550 mg/m2 (9 courses). DLTs occurred in 2/3 patients at 550 mg/m2 paclitaxel during cycle 1, including grade 3 hypotension and grade 4 anaphylaxis in 1 patient each. Common non-dose-limiting toxicities included bone marrow suppression and peripheral neuropathy. Response was evaluable in 14 patients and included mixed response (3), stable disease (5), and progressive disease (6). Conclusion Paclitaxel hypersensitivity reactions were dose limiting when the drug was administered as a 6-hr infusion. The MTD and recommended Phase II dose of paclitaxel administered as a 6-hr continuous intravenous infusion followed by standard dose intravenous ifosfamide is 425 mg/m2 paclitaxel. Pediatr Blood Cancer 2009;52:346,350. © 2008 Wiley-Liss, Inc. [source]

    How do parents perceive their adolescent's diabetes: a qualitative study

    DIABETIC MEDICINE, Issue 11 2006
    Aaron E. Carroll
    Abstract Background/aims The developmental tasks of adolescence, combined with physical changes, can interfere with self-management behaviour. Yet little is known about how parents view these challenges as they attempt to help their children cope with diabetes. Our objective was to understand how living with an adolescent with diabetes influences parents' perceptions of their child's well-being, their relationship with their child, and how they perceive the influence of peers and school on their child's diabetes. Methods Twenty-eight parents of adolescents with Type 1 diabetes, aged 13,18 years, participated in focus groups. Transcripts were analysed using qualitative methods to determine dominant themes and incidence density. Results Themes included how diabetes negatively influences their adolescent's lifestyle, how diabetes makes it difficult for parents to understand developmental challenges experienced by their child, concerns regarding the potential to develop long-term complications, perceptions on how diabetes impacts on their relationship with their child and relationships with peers and how their children's school impacts on their diabetes self-management Conclusions This qualitative focus group study provides insight into parental perceptions of adolescents living with Type 1 diabetes, specifically as it relates to lifestyle implications, relationships with parents, peers and physicians, and school experiences. [source]

    A double-blind, randomized, parallel group study to compare the efficacy, safety and tolerability of slow-release oral morphine versus methadone in opioid-dependent in-patients willing to undergo detoxification

    ADDICTION, Issue 9 2009
    Ekkehard Madlung-Kratzer
    ABSTRACT Aims Evaluation of the efficacy and safety of slow-release oral morphine (SROM) compared with methadone for detoxification from methadone and SROM maintenance treatment. Design Randomized, double-blind, double-dummy, comparative multi-centre study with parallel groups. Setting Three psychiatric hospitals in Austria specializing in in-patient detoxification. Participants Male and female opioid dependents (age > 18 years) willing to undergo detoxification from maintenance therapy in order to reach abstinence. Interventions Abstinence was reached from maintenance treatment by tapered dose reduction of either SROM or methadone over a period of 16 days. Measurements Efficacy analyses were based on the number of patients per treatment group completing the study, as well as on the control of signs and symptoms of withdrawal [measured using Short Opioid Withdrawal Scale (SOWS)] and suppression of opiate craving. In addition, self-reported somatic and psychic symptoms (measured using Symptom Checklist SCL-90-R) were monitored. Findings Of the 208 patients enrolled into the study, 202 were eligible for analysis (SROM: n = 102, methadone: n = 100). Completion rates were 51% in the SROM group and 49% in the methadone group [difference between groups: 2%; 95% confidence interval (CI): ,12% to 16%]. The rate of discontinuation in the study was high mainly because of patients voluntarily withdrawing from treatment. No statistically significant differences between treatment groups were found in terms of signs and symptoms of opiate withdrawal, craving for opiates or self-reported symptoms. SROM and methadone were both well tolerated. Conclusions Detoxification from maintenance treatment with tapered dose reduction of SROM is non-inferior to methadone. [source]

    Treatment satisfaction and efficacy of the rapid release formulation of sumatriptan 100 mg tablets utilising an early intervention paradigm in patients previously unsatisfied with sumatriptan

    INTERNATIONAL JOURNAL OF CLINICAL PRACTICE, Issue 12 2008
    L. C. Newman
    Summary Aims:, To evaluate treatment satisfaction, efficacy and functional ability of the rapid release formulation of sumatriptan 100 mg tablets (sumatriptan RT 100 mg) in an early intervention paradigm in patients who were dissatisfied with low-dose sumatriptan and not completely satisfied with their current migraine regimen. Methods:, Experienced migraineurs who reported a mild migraine pain phase, dissatisfaction with the previous sumatriptan treatment and some dissatisfaction with their current treatment regimen had no experience with sumatriptan at the 100 mg dose were enrolled in an open-label, single group study. Subjects were instructed to treat four migraine attacks within 30 min of the onset of mild pain. Treatment satisfaction was measured with the Patient Perception of Migraine Questionnaire Revised version (PPMQ-R) questionnaire. Results:, More than half of the subjects were either very satisfied or satisfied with the efficacy of early intervention sumatriptan RT 100 mg after each attack and at the follow-up study visit. The mean total PPMQ-R score was 75.2 out of 100. Between 63% and 73% of subjects were pain-free within 4 h of dosing. Between 79% and 90% of subjects reported an ability to function normally within 4 h of taking the study medication. Conclusion:, Subjects who were previously unsatisfied with lower doses of sumatriptan and less than very satisfied with their current treatment regimen were more likely to be satisfied or very satisfied with sumatriptan RT 100 mg in an early intervention paradigm. Results were consistent across four migraine attacks and at a follow-up visit. The treatment satisfaction results corresponded with positive results on efficacy measures and a functional status measure. [source]

    Genetic research into Alzheimer's Disease: a European focus group study on ethical issues

    INTERNATIONAL JOURNAL OF GERIATRIC PSYCHIATRY, Issue 1 2008
    Anco van der Vorm
    Abstract Background Nowadays, there is an increasing interest in the heritable aspects of Alzheimer's Disease (AD). The ethical implications of this kind of research are also attracting attention. However, relatively few open-ended qualitative studies have been carried out to study these aspects. Objective To explore and analyse ethical issues raised by genetic research into AD. Methods A modified focus group technique. Results Participants stressed the importance of relatives in genetic research and suggested a family consent procedure. The consent procedure ought to be more uniform within Europe and should allow for variation in the types of research being done. The long-term results of genetic research into AD are expected to be positive while the short-term results seem likely to be negative. The perception of AD as a disease could be changed by the results from genetic research into AD, and this could have effects at the individual level (feelings of guilt and responsibility for one's own health). Conclusions (1) The role of the family in genetic AD research differs from its role in other biomedical research into AD. The development of a family consent procedure might solve some informed consent problems. (2) Negative social consequences of genetic AD research are expected in the short term, but there are hopes of positive consequences in the long term. Copyright © 2007 John Wiley & Sons, Ltd. [source]

    Women's perceptions of chemotherapy-induced cognitive side affects on work ability: a focus group study

    JOURNAL OF CLINICAL NURSING, Issue 9-10 2010
    Fehmidah Munir
    Aims and objectives., To investigate women's awareness of chemotherapy-induced cognitive changes, their perception of cognitive limitations in carrying out daily tasks and subsequent return to work decisions and perceptions of work ability. Background., Evidence suggests that women diagnosed with breast cancer experience cognitive changes as a consequence of chemotherapy treatment. Although these changes tend to be subtle deficits in memory, concentration and the ability to organise information, there has been no published research identifying how they can impact patient's ability to work and subsequent employment decisions. Design., This was a qualitative study. Method., Data were collected from breast cancer survivors using semi-structured interviews with two focus groups (n = 6, n = 7). Interviews were transcribed verbatim and analysed using template analysis. Results., Data were categorised into four main themes: (1) awareness of cognitive changes during and following chemotherapy, (2) cognitive ability and confidence in return to work, (3) impact of cognitive changes on work ability and (4) information on the cognitive side effects of chemotherapy. Conclusions., The views and experiences of breast cancer survivors towards returning to work and subsequent work ability were affected by chemotherapy-induced cognitive impairment. More specifically the appraisal of returning to work and ability to manage work were influenced by three interrelated factors: (1) actual cognitive ability following chemotherapy, (2) awareness of cognitive failures by the women and their families and (3) the subsequent impact on their confidence in carrying out daily tasks including work tasks. Relevance to clinical practice., More information and support is needed to help patients with cancer to manage chemotherapy-induced cognitive impairments in home and workplace. Nurses are increasingly asked about the impact of cancer and its treatment on work and are therefore well positioned to offer this advice. Subsequently, nurses require additional knowledge and guidance to provide this information and support. [source]

    Families, food, and pester power: beyond the blame game?

    JOURNAL OF CONSUMER BEHAVIOUR, Issue 4 2007
    David Marshall
    Given the moral and medical panic surrounding rising rates of childhood obesity, there has been much debate about who on what is to be blamed, with parents and HFSS (high fat, salt, and sugar) food advertising often censured for their role. In this paper, we review the literature on childhood obesity and pester power, and the broader context of consumer socialization within the family. We then discuss findings from a questionnaire and focus group study of 8,11 year old children in New Zealand exploring aspects of their advertising experiences and everyday snack food consumption. HFSS food ads were well-represented in their repertoire of favorite ads, and they reported being influenced by these. However, their accounts of snacking highlighted the extent to which their actual consumption was shaped by parental agendas and concerns. Although they gravitated towards less healthy snack foods, fruit, and vegetables were included in their categorization and repertoire of snacks, perhaps reflecting the level of monitoring and gatekeeping exerted by their parents, who established ground rules for snacking and in many cases directly controlled their access to snack foods, although the limits imposed varied according to context. The children were generally accepting of this, although they drew on a range of strategies and tactics to access their preferred snacks. We conclude by considering the implications of this study for parents who seek to provide their children with a healthy diet and others concerned about health and public policy, and we suggest some avenues for developing knowledge in this area. Copyright © 2007 John Wiley & Sons, Ltd. [source]

    The challenge of using the low back pain guidelines: a qualitative research

    JOURNAL OF EVALUATION IN CLINICAL PRACTICE, Issue 4 2007
    Rachel Dahan MD MClSc
    Abstract Purpose, Current low back pain (LBP) clinical guidelines have helped to summarize the scientific evidence and research, but have failed to provide tools and guide family physicians (FPs). The purpose of this study is to identify barriers and facilitators for the implementation of LBP guidelines from family FPs' perspective. Methods, A qualitative focus group study of FPs in the north of Israel. Purposeful sampling was used to recruit participants, all of them board-certified FPs. Four focus groups were created, and discussions were taped, transcribed and analysed for major themes. Results, Focus groups findings have expanded the understanding of the intellectual and mental challenges faced by Israeli FPs caring for LBP patients and highlighted the many obstacles to implementing LBP guidelines. Physicians' decision-making, pertaining to LBP, functions on three levels simultaneously: the physicians' agenda based on familiarity with the guidelines; their need to remain grounded in the context of the specific patient,doctor relationship; and the constraints and demands of the physician's workplace, medical system and environment. Conclusions, Despite an overall positive attitude towards LBP guideline implementation, FPs found it hard to come to terms with the conflicting dimensions of LBP patient care. The patient,doctor interaction determined the outcome of the encounter, whether it complied with the guidelines and whether the encounter leads to a healing process or to a vicious circle of unnecessary utilization of services. [source]

    Design principles for virtual patients: a focus group study among students

    MEDICAL EDUCATION, Issue 6 2009
    Sören Huwendiek
    Objectives, This study aimed to examine what students perceive as the ideal features of virtual patient (VP) design in order to foster learning with a special focus on clinical reasoning. Methods, A total of 104 Year 5 medical students worked through at least eight VPs representing four different designs during their paediatric clerkship. The VPs were presented in two modes and differed in terms of the authenticity of the user interface (with or without graphics support), predominant question type (long- versus short-menu questions) and freedom of navigation (relatively free versus predetermined). Each mode was presented in a rich and a poor version with regard to the use of different media and questions and explanations explicitly directed at clinical reasoning. Five groups of between four and nine randomly selected students (n = 27) participated in focus group interviews facilitated by a moderator using a questioning route. The interviews were videotaped, transcribed and analysed. Summary reports were approved by the students. Results, Ten principles of VP design emerged from the analysis. A VP should be relevant, of an appropriate level of difficulty, highly interactive, offer specific feedback, make optimal use of media, help students focus on relevant learning points, offer recapitulation of key learning points, provide an authentic web-based interface and student tasks, and contain questions and explanations tailored to the clinical reasoning process. Conclusions, Students perceived the design principles identified as being conducive to their learning. Many of these principles are supported by the results of other published studies. Future studies should address the effects of these principles using quantitative controlled designs. [source]

    Promoting effective teaching and learning: hospital consultants identify their needs

    MEDICAL EDUCATION, Issue 2 2000
    Gibson
    Objectives The aim of this study was to help hospital consultants identify their needs in relation to teaching skills, leading to the development of a teacher training programme. Design The study was directed at all 869 consultants in the region and initially involved a postal questionnaire which had a 60·5% response rate. Setting Hospitals throughout Northern Ireland. Subjects Hospital consultants. Results Results from this questionnaire indicated that while the majority of respondents were interested teachers, only 34% had received any teacher training. The questionnaire was followed by a focus group study involving three groups of consultants drawn randomly from those who had responded to the questionnaire. Participants in these groups identified the following key areas of hospital education: qualities of hospital teachers; selection procedures; problems of teaching in hospitals; the need for teacher training and how it should be provided. Conclusion The study highlighted that hospital teachers need to acquire and update their teaching skills through attending courses that should include basic teaching and assessment/appraisal skills. These courses should last 1 or 2 days and be provided at a regional or subregional level. As a result of this study, teacher training courses have been developed in this region. [source]

    Phase I study of decitabine with doxorubicin and cyclophosphamide in children with neuroblastoma and other solid tumors: A children's oncology group study,,

    PEDIATRIC BLOOD & CANCER, Issue 4 2010
    MRCP, Rani E. George MD
    Abstract Background Demethylating agents may alter the expression of genes involved in chemotherapy resistance. We conducted a phase I trial to determine the toxicity and molecular effects of the demethylating agent, decitabine, followed by doxorubicin and cyclophosphamide in children with refractory solid tumors. Procedure Stratum A included children with any solid tumor; Stratum B included neuroblastoma patients only. Patients received a 1-hr decitabine infusion for 7 days, followed by doxorubicin (45,mg/m2) and cyclophosphamide (1,g/m2) on day 7. Pharmacokinetic studies were performed after the first dose of decitabine. Biological studies included methylation and gene expression analyses of caspase-8, MAGE-1 and fetal hemoglobin (HbF), and expression profiling of pre- and post-treatment peripheral blood and bone marrow cells. Results The maximum-tolerated dose of decitabine was 5,mg/m2/day for 7 days. Dose-limiting toxicities at 10,mg/m2/day were neutropenia and thrombocytopenia. Decitabine exhibited rapid clearance from plasma. Three of 9 patients in Stratum A and 4/12 patients in Stratum B had stable disease for ,4 months. Sustained MAGE-1 demethylation and increased HbF expression were observed in the majority of patients post-treatment (12/20 and 14/16, respectively). Caspase-8 promoter demethylation and gene expression were seen in 2/7 bone marrow samples. Differentially expressed genes were identified by microarray analysis. Conclusion Low-dose decitabine when combined with doxorubicin/cyclophosphamide has tolerable toxicity in children. However, doses of decitabine capable of producing clinically relevant biologic effects were not well tolerated with this combination. Alternative strategies of combining demethylating agents with non-cytotoxic, biologically targeted agents such as histone deactelyase inhibitors should be explored. Pediatr Blood Cancer. 2010;55:629,638. © 2010 Wiley-Liss, Inc. [source]

    Improved safety with equivalent asthma control in adults with chronic severe asthma on high-dose fluticasone propionate

    RESPIROLOGY, Issue 3 2001
    Norbert Berend
    Objective: High-dose inhaled corticosteroids (ICS) have been associated with the same side-effects as oral corticosteroids. Beclomethasone dipropionate (BDP) and budesonide (BUD) in doses greater than 2000 ,g/day are used regularly in severe asthma, despite the fact that safety and efficacy data at such high doses are limited. Fluticasone propionate (FP) has been promoted as being twice as potent clinically as BDP or BUD at doses of 2000 ,g/day or less with a similar safety profile. The aim of this study was to compare the efficacy and safety of FP with BDP and BUD in 133 symptomatic adult asthmatics requiring at least 1750 ,g/day of BDP or BUD. Methodology: Patients fulfilling the entry criteria were randomized to receive either their regular ICS medication or FP at approximately half the microgram dose for 6 months in an open, parallel group study. The primary efficacy measure was based on morning peak expiratory flow measurements recorded by patients on daily record cards, while determination of safety was based on a number of endpoints including changes in bone turnover indices, the incidence of topical side-effects and assessments of quality of life. Results: It was shown that patients who were switched to FP, but not those continuing with BDP or BUD, had significant increases in levels of morning serum cortisol and the urine cortisol:creatinine ratio while maintaining asthma control. Serum osteocalcin and the pyridinoline:creatinine ratio, as well as the deoxypyridinoline:creatinine ratio, were also shown to increase only in the FP group. Subjective assessments such as quality of life score, the incidence and ease of bruising, and reports of hoarseness also favoured the FP group. Conclusions: It is concluded that, at the doses studied and with the delivery devices used clinically, FP is at least as effective as BDP/BUD in the management of severe asthma and may offer clinical advantages with respect to steroid-related adverse effects. [source]

    Randomized, prospective, placebo-controlled trial of bosentan in interstitial lung disease secondary to systemic sclerosis,

    ARTHRITIS & RHEUMATISM, Issue 7 2010
    J. R. Seibold
    Objective Endothelin is implicated as a participatory pathway in systemic sclerosis (SSc). We tested this hypothesis in a 12-month trial of bosentan, a nonselective endothelin receptor antagonist, as a therapy for SSc-related interstitial lung disease (ILD). Method Patients with SSc and significant ILD were recruited to this prospective, double-blind, randomized, placebo-controlled, parallel group study. The inclusion criteria were designed to select a cohort enriched for patients with active and progressive disease. Exclusion factors included significant pulmonary hypertension. Patients with a diffusing capacity for carbon monoxide of <80% predicted and a 6-minute walk distance of 150,500 meters or a 6-minute walk distance of ,500 meters with a decrease in oxygen saturation received bosentan or placebo. The primary efficacy end point was a change in the 6-minute walk distance from baseline up to month 12. Secondary end points included time to death or worsening results of pulmonary function tests (PFTs). The safety and tolerability of bosentan were also assessed. Results Among the 163 patients, 77 were randomized to receive bosentan, and 86 were randomized to receive placebo. No significant difference between treatment groups was observed for change in the 6-minute walk distance up to month 12. No deaths occurred in this study group. Forced vital capacity and diffusing capacity for carbon monoxide remained stable in the majority of patients in both groups. Significant worsening of PFT results occurred in 25.6% of patients receiving placebo and 22.5% of those receiving bosentan (P not significant). Conclusion No improvement in exercise capacity was observed in the bosentan-treated group compared with the placebo group, and no significant treatment effect was observed for the other end points. Although many outcome variables were stable, bosentan did not reduce the frequency of clinically important worsening. These data do not support the use of endothelin receptor antagonists as therapy for ILD secondary to SSc. [source]

    Identifying research priorities and research needs among health and research professionals in psycho-oncology

    ASIA-PACIFIC JOURNAL OF CLINICAL ONCOLOGY, Issue 3 2010
    Monika DZIDOWSKA
    Abstract Aim: To identify and prioritize the key research questions in psycho-oncology in order to guide the development of large multicenter clinically relevant studies. Methods: All members of the Psycho-Oncology Co-operative Research Group (n = 295) were invited to participate in an online survey and 180 responded (response rate = 61%). Participants rated eight priority research areas identified from a previous focus group study on a five-point scale, and ranked their top four priority areas. Within the four ranked research areas, participants selected the three most important specific research questions. Results: The highest rated research priority areas were distress identification (23.3%), survivorship (22.7%), and distress management (15.3%), followed by issues relating to health services (9.7%) and carers (8.0%). Interventions were commonly nominated among the most important research questions within each priority area. The single most important research question identified by 44% of the sample was to "Determine the most acceptable, reliable and valid screening tool to be administered routinely at diagnosis and at other key transition points to identify distress and psychosocial needs". Conclusion: This is the first Australian study to explore research priorities in psycho-oncology, and the first international study to explore these issues in depth. To ensure that the research effort is strategic, clinically relevant and cost-effective, clear priorities need to be established. The results of this survey will enable limited resources to focus on key research questions of direct clinical benefit. [source]

    Healthcare professionals' views on two computer-based decision aids for women choosing mode of delivery after previous caesarean section: a qualitative study

    BJOG : AN INTERNATIONAL JOURNAL OF OBSTETRICS & GYNAECOLOGY, Issue 7 2009
    KM Rees
    Objective, To explore healthcare professionals' views about decision aids, developed by the DiAMOND study group, for women choosing mode of delivery after a previous caesarean section. Design/Methods, A qualitative focus group study. Data were analysed thematically. Setting, Two city maternity units, surrounding community midwife units and general practitioner (GP) practices in southwest England. Sample, Twenty-eight healthcare professionals, comprising obstetricians, hospital and community midwives and GPs, who participated in six focus groups. Results, Participants were generally positive about the decision aids. Most thought they should be implemented during early pregnancy in the community, but should be accessible throughout pregnancy, with any arising questions discussed with an obstetrician nearer to term. Perceived barriers to implementation included service issues (e.g. time pressure, cost and access), computer issues (e.g. computer literacy) and people issues (e.g. women's prior delivery preferences and clinician preference). Facilitators to implementation included access to more standardised and reliable information and empowerment of the user. Self-accessing the aids, increased awareness of decision aids among healthcare professionals and incorporation of aids into usual care were suggested as possible ways to improve implementation success. Conclusions, This study gives insight into healthcare professionals' views on the role of decision aids for women choosing a mode of delivery after a prior caesarean section. It highlights potential obstacles to their implementation and ways to address these. Such aids could be a useful adjunct to current antenatal care. [source]

    Pharmacokinetics and pharmacodynamics of LC15-0444, a novel dipeptidyl peptidase IV inhibitor, after multiple dosing in healthy volunteers

    BRITISH JOURNAL OF CLINICAL PHARMACOLOGY, Issue 6 2009
    Kyoung Soo Lim
    WHAT IS ALREADY KNOWN ABOUT THIS SUBJECT , The importance of efficient drug development using biomarkers has been increasingly emphasized, from preclinical studies to clinical trials. , However, as yet few ,validated' or ,qualified' biomarkers are used in early-stage drug development in terms of clinical pharmacology and disease pathophysiology. WHAT THIS STUDY ADDS , This first-time-in-human study provides evidence of the pharmacological activity of LC15-0444 in humans, by using dipeptidyl peptidase IV activity and active glucagon-like peptide-1 concentrations. , LC15-0444 possesses pharmacokinetic and pharmacodynamic characteristics that support a once-daily dosing regimen. AIMS LC15-0444 is a selective and competitive inhibitor of dipeptidyl peptidase (DPP) IV with potential for the treatment of Type 2 diabetes. The aim was to investigate the pharmacokinetic (PK) and pharmacodynamic (PD) profiles after multiple oral ascending doses of LC15-0444 in healthy male subjects. METHODS A dose block-randomized, double-blind, placebo-controlled, parallel group study was performed in three groups with 10 subjects (eight for active drug; two for placebo) per group; each group received 200, 400 or 600 mg of LC15-0444 once daily for 10 days. Blood and urine samples were collected up to 24 h after the first dosing and up to 72 h after the last dosing. RESULTS The LC15-0444 concentration,time profiles exhibited characteristics of multicompartment disposition. No dose- or time-dependent change in PK parameters was observed. Mean elimination half-life was in a range 16.6,20.1 h in the dose groups. Mean renal clearance and fraction of unchanged drug excreted in urine was 18.6,21.9 and 0.40,0.48 l h,1, respectively. In the steady state, mean accumulation ratios by dose groups were between 1.22 and 1.31. More than 80% inhibition of DPP IV activity from baseline was sustained for >24 h in all dose groups. CONCLUSIONS This study provides evidence of the pharmacological activity of LC15-0444 in humans. LC15-0444 possesses PK and PD characteristics that support a once-daily dosing regimen. [source]

    Effect of renal impairment on the pharmacokinetics of bupropion and its metabolites

    BRITISH JOURNAL OF CLINICAL PHARMACOLOGY, Issue 2 2007
    Miia Turpeinen
    What is already known about this subject ,,There is an ongoing debate regarding the effect of renal impairment on CYP related metabolic activities. ,,The possible effect of renal impairment on hepatic CYP2B6 activity, or on bupropion pharmacokinetics in renally impaired subjects without dialysis treatment has not yet been investigated. What this study adds ,,Bupropion clearance was found to be significantly decreased in patients with renal impairment. ,,This study provides further evidence for interplay between the role of the kidney and liver in drug disposition, and opens novel lines of research with respect to the regulation of CYP2B6. Aims To investigate the effect of kidney disease on bupropion pharmacokinetics and on cytochrome P450 (CYP) 2B6 activity as measured by bupropion hydroxylation. Methods In an open parallel group study, 17 healthy, nonsmoking subjects and 10 patients with impaired kidney function received a single 150 mg oral dose of sustained release bupropion. Plasma concentrations of bupropion and its metabolites were measured for up to 72 h. Subjects were genotyped for the CYP2B6 SNPs 1459 C>T, 785 A>G and 516 G>T. Results Bupropion AUC was 126% higher (P < 0.0001, 95% CI +72%, +180%), Cmax 86% higher (P = 0.001, 95% CI +40%, +131%), CL/F 63% lower (P = 0.001, 95% CI ,29%, ,96%), and t1/2 140% longer (P = 0.001, 95% CI +76%, +204%) in renally impaired patients. However, only minor changes were detected in the concentrations of the metabolites. In renally impaired subjects the hydroxybupropion : bupropion AUC ratio was decreased by 66% (P = < 0.0001, 95% CI ,19%, ,114%) and the hydrobupropion : bupropion AUC ratio by 69% (P = 0.001, 95% CI +8%, ,146%) compared with controls. Conclusions The CL/F of bupropion was significantly lower in subjects with renal impairment. Because the principal metabolites of bupropion possess similar pharmacological activity to the parent compound, dosage recommendations for patients with renal impairment cannot be given. A direct effect of renal impairment on CYP2B6 activity could not be demonstrated by the present study design. [source]

    Alpha-dihydroergocryptine in the treatment of de novo parkinsonian patients: results ofa multicentre, randomized, double-blind, placebo-controlled study

    ACTA NEUROLOGICA SCANDINAVICA, Issue 6 2000
    B. Bergamasco
    Introduction, A multicentre, randomized, double-blind, placebo-controlled, parallel group study was carried out in 123 patients suffering from never treated (de novo) idiopathic Parkinson's disease (PD). The aim of the study was to confirm the efficiency and safety of ,-dihydroergocryptine (,-DHEC) given as monotherapy in the symptomatic treatment of PD. The total score of the Unified Parkinson's Disease Rating Scale (UPDRS) was identified as the efficacy target variable. Patients and methods, Sixty-two patients (32 males, 30 females, mean age±SD 64±10) were randomized to ,-dihydroergocryptine and 61 (30 males, 31 females, mean age 63.8±9.1) to placebo. According to the experimental design, a 18-month double-blind phase vs placebo was followed. Two interim analyses were planned both at the 3rd and 12th month of treatment, in order to avoid continuation on placebo, if clear differences between groups were found (stopping criterium: nominal significance level equal to 0.022 in the analysis of the target variable). Analysis of variance was performed both on the per protocol (PP) and intent-to-treat (ITT) sample. Results, The results on the first interim analysis showed significant differences between treatment groups of the UPDRS total score both in the ITT (115 patients, ,-DHEC: No. 56; placebo: No. 59; P=0.019) and PP (96 patients, ,-DHEC: No. 46; placebo: No. 50; P=0.001) sample, why the trial was stopped. At the time of stopping the trial, 73 patients (,-DHEC: No. 37; placebo: No. 36) had reached the 6-month observation visit; the analysis carried out on this subset of patients confirmed the efficacy of ,-dihydroergocryptine in early PD and the correctness of the decision to stop. The incidence of adverse drug reactions (ADR) did not differ between ,-dihydroergocryptine and placebo recipients, gastrointestinal complaints being the most frequent. Conclusion, The results indicate that ,-dihydroergocryptine is safe and effective in improving symptoms of de novo parkinsonian patients. [source]

    Effect of a 4-week treatment with theophylline on sputum eosinophilia and sputum eosinophil chemotactic activity in steroid-naive asthmatics

    CLINICAL & EXPERIMENTAL ALLERGY, Issue 8 2000
    Louis
    Background The precise mechanism of action of theophylline in asthma is not fully understood but recent data have drawn attention to its potential anti-inflammatory effect. Objective The purpose of this study was to assess the effect of theophylline on sputum eosinophilia and sputum eosinophil chemotactic activity in steroid-naive asthmatics. Method We performed a 4-week randomized double-blind, placebo-controlled, parallel group study in 21 mild to moderate steroid-naive asthmatics whose sputum eosinophilia was found twice > 5% during the run in period. Eleven subjects received 600 mg/24 h theophylline for the first 2 weeks and 900 mg/24 h for the last 2 weeks while 10 subjects took a placebo for 4 weeks. Sputum was induced after 2 and 4 weeks of treatment and 1 week after stopping the treatment. The sputum samples were compared for their cell counts, eosinophil cationic protein (ECP) levels and eosinophil chemotactic activity using micro-Boyden chambers. Results Serum theophylline concentrations reached 7 and 11 ,g/mL at V3 and V4, respectively. Intragroup comparisons showed that theophylline, but not placebo, caused a significant reduction in sputum eosinophil counts at V3 (62 ± 10% from baseline, P < 0.01) and a strong trend at V4 (67 ± 16% from baseline, P = 0.07) when compared to baseline. The intergroup difference obtained after comparing the area under the curve over the 4 week treatment period only approached the statistical significance (P = 0.08). At baseline the fluid phase of the sputum contained a significant eosinophil chemotactic activity which was inhibited after a 4-week treatment by theophylline (P < 0.01) but not by placebo. The mean sputum theophylline levels after 4 weeks of treament (1.7 ,g/mL) was lower than that required to cause significant inhibition of eosinophil chemotaxis in vitro. Conclusion Theophylline decreases the natural sputum eosinophil chemotactic activity present in asthmatics. However, when using a small sample size, the 35% reduction in sputum eosinophilia achieved by theophylline failed to reach statistical significance when compared to that seen after placebo. [source]