A brief history of the International Fusion Research Council (IFRC) is given and the minutes of the 1976 meeting in Garching are summarized. At the Garching meeting, the IFRC evaluated the quality of papers presented at recent IAEA conferences on plasma physics and controlled thermonuclear research, and made recommendations on the organization and timing of future meetings on nuclear fusion
Vale Claire L
Full Text Available Abstract Background We aimed to establish levels of consumer involvement in randomised controlled trials (RCTs, meta-analyses and other studies carried out by the UK Medical Research Council (MRC Clinical Trials Unit across the range of research programs, predominantly in cancer and HIV. Methods Staff responsible for studies that were included in a Unit Progress Report (MRC CTU, April 2009 were asked to complete a semi-structured questionnaire survey regarding consumer involvement. This was defined as active involvement of consumers as partners in the research process and not as subjects of that research. The electronic questionnaires combined open and closed questions, intended to capture quantitative and qualitative information on whether studies had involved consumers; types of activities undertaken; recruitment and support; advantages and disadvantages of involvement and its perceived impact on aspects of the research. Results Between October 2009 and April 2010, 138 completed questionnaires (86% were returned. Studies had been conducted over a 20 year period from 1989, and around half were in cancer; 30% in HIV and 20% were in other disease areas including arthritis, tuberculosis and blood transfusion medicine. Forty-three studies (31% had some consumer involvement, most commonly as members of trial management groups (TMG [88%]. A number of positive impacts on both the research and the researcher were identified. Researchers generally felt involvement was worthwhile and some felt that consumer involvement had improved the credibility of the research. Benefits in design and quality, trial recruitment, dissemination and decision making were also perceived. Researchers felt they learned from consumer involvement, albeit that there were some barriers. Conclusions Whilst most researchers identified benefits of involving consumers, most of studies included in the survey had no involvement. Information from this survey will inform the development
Vale, Claire L; Thompson, Lindsay C; Murphy, Claire; Forcat, Silvia; Hanley, Bec
We aimed to establish levels of consumer involvement in randomised controlled trials (RCTs), meta-analyses and other studies carried out by the UK Medical Research Council (MRC) Clinical Trials Unit across the range of research programs, predominantly in cancer and HIV. Staff responsible for studies that were included in a Unit Progress Report (MRC CTU, April 2009) were asked to complete a semi-structured questionnaire survey regarding consumer involvement. This was defined as active involvement of consumers as partners in the research process and not as subjects of that research. The electronic questionnaires combined open and closed questions, intended to capture quantitative and qualitative information on whether studies had involved consumers; types of activities undertaken; recruitment and support; advantages and disadvantages of involvement and its perceived impact on aspects of the research. Between October 2009 and April 2010, 138 completed questionnaires (86%) were returned. Studies had been conducted over a 20 year period from 1989, and around half were in cancer; 30% in HIV and 20% were in other disease areas including arthritis, tuberculosis and blood transfusion medicine. Forty-three studies (31%) had some consumer involvement, most commonly as members of trial management groups (TMG) [88%]. A number of positive impacts on both the research and the researcher were identified. Researchers generally felt involvement was worthwhile and some felt that consumer involvement had improved the credibility of the research. Benefits in design and quality, trial recruitment, dissemination and decision making were also perceived. Researchers felt they learned from consumer involvement, albeit that there were some barriers. Whilst most researchers identified benefits of involving consumers, most of studies included in the survey had no involvement. Information from this survey will inform the development of a unit policy on consumer involvement, to guide future
"Trade and Industry Secretary Patricia Hewitt today launched 'Research Councils UK' - a new strategic partnership that will champion research in science, engineering and technology across the UK" (1 page).
Carol A Clausen; Frederick Green III; Grant T. Kirker; Stan T. Lebow
This report summarizes presentations and comments from the inaugural Wood Protection Research Council meeting. Research needs for the wood protection industry were identified and prioritized. Methods for successfully addressing research needs were discussed by industry, academia, and association representatives.
Aguillaume, C J
As a result of the sudden political change that came with the Clinton Administration, RU-486's manufacturer, Roussel-Uclaf, and the Population Council agreed on April 20, 1992, on the manufacture and distribution of RU-486 in the US. In the US, there are less than 1.6 million induced abortions annually. From now on, US women will be able to have a choice between medical and surgical abortion. The Population Council and Roussel-Uclaf have had a contract since 1982. The Council is solely responsible for the phase 2 clinical trial of RU-486 in the US and other countries. It must present to the US Food and Drug Administration (FDA) an amendment allowing it to begin phase 3 clinical trials. The Council will also lead the US medical facilities in this study. It will identify partners for future production of RU-486 and its distribution in the US. It will also submit to FDA a New Drug Application (NDA). FDA will review the scientific literature on RU-486 and evaluate all data submitted by the Population Council. There are still obstacles to be surmounted. The Population Council must demonstrate good judgment when selecting the criteria for choosing a pharmaceutical firm before a Technical Committee which will be part of a group of players promoting women's health, scientific experts, and other interested parties. It must find the necessary funds to conduct the clinical trials and prepare the NDA. Phase 3 clinical trials in the US must have at least 2000 women. They will test RU-486's efficacy, safety, and acceptability among women choosing medical abortion over surgical abortion. Since the Council operates in almost all countries in the world, has innovated contraceptive research and development activities, and has been endorsed by the UN, product approval of RU-486 in the US will affect policy in all countries concerned about abortion.
Arseneau, R.; Zelle, J.
A study was carried out to produce a compendium of electric and magnetic field levels in various environments throughout Canada. The contribution of the National Research Council of Canada in cooperation with Ottawa Hydro was to study the magnetic field environment of 29 sites in the Ottawa area, including private residences, place of employment, distribution and transmission lines, and close to padmount transformers. At most sites the electric fields were too low to be measured. Magnetic fields near padmount transformers can be larger than 300 mG, however this rapidly decreases and at 3 feet from the transformers is below 20 mG. Magnetic fields of unbalanced distribution lines can be larger than the fields of balanced lines. The magnetic fields of a high voltage transmission line were measurable at distances up to 100 m from the line. Electric fields were low outside the right-of-way. 6 refs., 4 figs., 2 tabs
Spain’s biggest scientific institution - the Spanish National Research Council (CSIC) - has announced it is in financial difficulty and that it has already clawed back unspent cash for research projects funded before 2012 in order to survive until October.
Since the 2011 National Academies’ National Research Council (NRC) review of the IRIS Program's assessment of Formaldehyde, EPA and NRC have had an ongoing relationship into the improvements of developing the IRIS Assessments.
Darlaston, J.; McAllister, S.
The European Pressure Equipment Research Council (EPERC) is a European Network of industries, research laboratories, inspection bodies and governmental institutions set up to foster co-operative research for the greater benefit of the European industry. The concept of a European Research Council originated at the PVRC meeting in Cannes in 1989 and since this time volunteers from the industry, research laboratories and of the European Commission Joint Research Centre, Petten have worked together to create a Statute for EPERC. In the context of the pressure equipment industry, the creation of EPERC is extremely pertinent, since in the near future, a Council directive on pressure equipment will replace the existing national regulations. In parallel to this, work is in progress for the elaboration of European Standards. It is useful to recall that ''Harmonised Standards'' will be the privileged means of complying with the Essential Safety Requirements of the directive. (author)
..., Forestry Research Advisory Council, USDA Forest Service Research and Development, Mail Stop 1120, 1400... Service Office of the Deputy Chief for Research and Development, 202-205-1665. Individuals who use telecommunication devices for the deaf (TDD) may call the Federal Information Relay Service (FIRS) at 1-800-877-8339...
Syndikus, Isabel; Morgan, Rachel C.; Sydes, Matthew R.; Graham, John D.; Dearnaley, David P.
Purpose: In men with localized prostate cancer, dose-escalated conformal radiotherapy (CFRT) improves efficacy outcomes at the cost of increased toxicity. We present a detailed analysis to provide further information about the incidence and prevalence of late gastrointestinal side effects. Methods and Materials: The UK Medical Research Council RT01 trial included 843 men with localized prostate cancer, who were treated for 6 months with neoadjuvant radiotherapy and were randomly assigned to either 64-Gy or 74-Gy CFRT. Toxicity was evaluated before CFRT and during long-term follow-up using Radiation Therapy Oncology Group (RTOG) grading, the Late Effects on Normal Tissue: Subjective, Objective, Management (LENT/SOM) scale, and Royal Marsden Hospital assessment scores. Patients regularly completed Functional Assessment of Cancer Therapy--Prostate (FACT-P) and University of California, Los Angeles, Prostate Cancer Index (UCLA-PCI) questionnaires. Results: In the dose-escalated group, the hazard ratio (HR) for rectal bleeding (LENT/SOM grade ≥2) was 1.55 (95% CI, 1.17-2.04); for diarrhea (LENT/SOM grade ≥2), the HR was 1.79 (95% CI, 1.10-2.94); and for proctitis (RTOG grade ≥2), the HR was 1.64 (95% CI, 1.20-2.25). Compared to baseline scores, the prevalence of moderate and severe toxicities generally increased up to 3 years and than lessened. At 5 years, the cumulative incidence of patient-reported severe bowel problems was 6% vs. 8% (standard vs. escalated, respectively) and severe distress was 4% vs. 5%, respectively. Conclusions: There is a statistically significant increased risk of various adverse gastrointestinal events with dose-escalated CFRT. This remains at clinically acceptable levels, and overall prevalence ultimately decreases with duration of follow-up.
... Advisory Council, USDA Forest Service Research and Development, Mail Stop 1120, 1400 Independence Ave. SW... of the Deputy Chief for Research and Development, 202-205-1665. Individuals who use telecommunication devices for the deaf (TDD) may call the Federal Information Relay Service (FIRS) at 1-800-877-8339 between...
... and proposals by May 31, 2012 to Daina Apple, Designated Federal Officer, Forestry Research Advisory...: Daina Apple, Forest Service, Office of the Deputy Chief for Research and Development, (202) 205-1665. SUPPLEMENTARY INFORMATION: The meeting is open to the public. Council discussion is limited to Forest Service...
Andersen, Per Dannemand; Borup, Mads
This paper addresses the issue of foresight and strategy processes of national research councils and research programmes. It is based on a study of strategy processes in national research councils and programmes and the challenges faced by their strategy activities. We analysed the strategy...... processes of two organisations: the Danish Technical Research Council and the Danish Energy Research Programme. We analysed the mechanisms of the strategy processes and studied the actors involved. The actors’ understanding of strategy was also included in the analysis. Based on these analyses we argue...... that the impact of foresight exercises can be improved if we have a better understanding of the traditions and new challenges faced by the research councils. We also argue that a more formal use of foresight elements might improve the legitimacy and impact of the strategic considerations of research councils...
... send their names and proposals by August 1, 2011 to Daina Apple, Designated Federal Officer, Forestry... INFORMATION CONTACT: Daina Apple, Forest Service Office of the Deputy Chief for Research and Development, (202) 205-1665. SUPPLEMENTARY INFORMATION: The meeting is open to the public. Council discussion is limited...
Using the Medical Research Council framework for the development and evaluation of complex interventions in a theory-based infant feeding intervention to prevent childhood obesity: the baby milk intervention and trial.
Lakshman, Rajalakshmi; Griffin, Simon; Hardeman, Wendy; Schiff, Annie; Kinmonth, Ann Louise; Ong, Ken K
We describe our experience of using the Medical Research Council framework on complex interventions to guide the development and evaluation of an intervention to prevent obesity by modifying infant feeding behaviours. We reviewed the epidemiological evidence on early life risk factors for obesity and interventions to prevent obesity in this age group. The review suggested prevention of excess weight gain in bottle-fed babies and appropriate weaning as intervention targets; hence we undertook systematic reviews to further our understanding of these behaviours. We chose theory and behaviour change techniques that demonstrated evidence of effectiveness in altering dietary behaviours. We subsequently developed intervention materials and evaluation tools and conducted qualitative studies with mothers (intervention recipients) and healthcare professionals (intervention deliverers) to refine them. We developed a questionnaire to assess maternal attitudes and feeding practices to understand the mechanism of any intervention effects. In addition to informing development of our specific intervention and evaluation materials, use of the Medical Research Council framework has helped to build a generalisable evidence base for early life nutritional interventions. However, the process is resource intensive and prolonged, and this should be taken into account by public health research funders. This trial is registered with ISRTCN: 20814693 Baby Milk Trial.
Using the Medical Research Council Framework for the Development and Evaluation of Complex Interventions in a Theory-Based Infant Feeding Intervention to Prevent Childhood Obesity: The Baby Milk Intervention and Trial
Full Text Available Introduction. We describe our experience of using the Medical Research Council framework on complex interventions to guide the development and evaluation of an intervention to prevent obesity by modifying infant feeding behaviours. Methods. We reviewed the epidemiological evidence on early life risk factors for obesity and interventions to prevent obesity in this age group. The review suggested prevention of excess weight gain in bottle-fed babies and appropriate weaning as intervention targets; hence we undertook systematic reviews to further our understanding of these behaviours. We chose theory and behaviour change techniques that demonstrated evidence of effectiveness in altering dietary behaviours. We subsequently developed intervention materials and evaluation tools and conducted qualitative studies with mothers (intervention recipients and healthcare professionals (intervention deliverers to refine them. We developed a questionnaire to assess maternal attitudes and feeding practices to understand the mechanism of any intervention effects. Conclusions. In addition to informing development of our specific intervention and evaluation materials, use of the Medical Research Council framework has helped to build a generalisable evidence base for early life nutritional interventions. However, the process is resource intensive and prolonged, and this should be taken into account by public health research funders. This trial is registered with ISRTCN: 20814693 Baby Milk Trial.
Al-Shukaili, Ahmed; Al-Maniri, Abdullah
Writing a research proposal can be a challenging task for young researchers. This article explains how to write a strong research proposal to apply for funding, specifically, a proposal for The Research Council (TRC) of Oman. Three different research proposal application forms are currently used in TRC, including Open Research Grant (ORG), Graduate Research Support Program (GRSP), and Faculty-mentored Undergraduate Research Award Program (FURAP). The application forms are filled and submitted...
... apportionment of funds. Advisory Council Organization The Council will be comprised of not more than 20 members. The members appointed to the Council will be fairly balanced in terms of the points of view... relevancy to a membership category. Geographic balance and a balanced distribution among the categories are...
The Swedish Research Councils' Laboratory herewith presents its progress report for 1975. The report summarizes the current projects carried out by the research groups working at the laboratory. The very efficient assistance of the staff of the laboratory is greatfully acknowledged. The laboratory has been financially supported by the Atomic Research Council, the Medical Research Council, the Natural Science Research Council, and the Board of Technical Development. Valuable support in various ways has also been given by the Atomic Energy Company (AB Atomenergi). (author)
This article presents the findings from qualitative interviews with nine Danish council reporters on how they use the Internet for research on council affairs. Through qualitative interviews, the article aims to qualify and expand findings from survey research on journalists' use of the Internet...... for research and asks how much value journalists add to information found on the Internet and how important Internet research is compared to other types of research. The journalists interviewed found that the council website was useful as a provider of factual information about the council and a searchable...
South, Annabelle; Hanley, Bec; Gafos, Mitzy; Cromarty, Ben; Stephens, Richard; Sturgeon, Kate; Scott, Karen; Cragg, William J; Tweed, Conor D; Teera, Jacqueline; Vale, Claire L
Patient and public involvement (PPI) in studies carried out by the UK Medical Research Council Clinical Trials Unit (MRC CTU) at University College London varies by research type and setting. We developed a series of case studies of PPI to document and share good practice. We used purposive sampling to identify studies representing the scope of research at the MRC CTU and different approaches to PPI. We carried out semi-structured interviews with staff and patient representatives. Interview notes were analysed descriptively to categorise the main aims and motivations for involvement; activities undertaken; their impact on the studies and lessons learned. We conducted 19 interviews about ten case studies, comprising one systematic review, one observational study and 8 randomised controlled trials in HIV and cancer. Studies were either open or completed, with start dates between 2003 and 2011. Interviews took place between March and November 2014 and were updated in summer 2015 where there had been significant developments in the study (i.e. if the study had presented results subsequent to the interview taking place). A wide range of PPI models, including representation on trial committees or management groups, community engagement, one-off task-focused activities, patient research partners and participant involvement had been used. Overall, interviewees felt that PPI had a positive impact, leading to improvements, for example in the research question; study design; communication with potential participants; study recruitment; confidence to carry out or complete a study; interpretation and communication of results; and influence on future research. A range of models of PPI can benefit clinical studies. Researchers should consider different approaches to PPI, based on the desired impact and the people they want to involve. Use of multiple models may increase the potential impacts of PPI in clinical research.
The Science Granting Councils Initiative in sub-Saharan Africa aims to ... The strategy identifies a wide range of activities to collect, package, and share lessons ... Organization for Women in Science for the Developing World (OWSD), IDRC is ...
Dept. Trade & Industry
Science and Innovation Minister, Lord Sainsbury, today announced the outcome of a review of the Council for the Central Laboratory of the Research Councils (CCLRC). The report is the second stage of a five-yearly review, which outlines ways to strengthen and promote greater value for money from the UK's investment in science (1 page).
Al-Shukaili, Ahmed; Al-Maniri, Abdullah
Writing a research proposal can be a challenging task for young researchers. This article explains how to write a strong research proposal to apply for funding, specifically, a proposal for The Research Council (TRC) of Oman. Three different research proposal application forms are currently used in TRC, including Open Research Grant (ORG), Graduate Research Support Program (GRSP), and Faculty-mentored Undergraduate Research Award Program (FURAP). The application forms are filled and submitted electronically on TRC website. Each of the proposals submitted to TRC is selected through a rigorous reviewing and screening process. Novelty and originality of the research idea is the most crucial element in writing a research proposal. Performing an in-depth review of the literature will assist you to compose a good researchable question and generate a strong hypothesis. The development of a good hypothesis will offer insight into the specific objectives of a study. Research objectives should be focused, measurable, and achievable by a specific time using the most appropriate methodology. Moreover, it is essential to select a proper study design in-line with the purpose of the study and the hypothesis. Furthermore, social/economic impact and reasonable budget of proposed research are important criteria in research proposal evaluation by TRC. Finally, ethical principles should be observed before writing a research proposal involving human or animal subjects.
Full Text Available Writing a research proposal can be a challenging task for young researchers. This article explains how to write a strong research proposal to apply for funding, specifically, a proposal for The Research Council (TRC of Oman. Three different research proposal application forms are currently used in TRC, including Open Research Grant (ORG, Graduate Research Support Program (GRSP, and Faculty-mentored Undergraduate Research Award Program (FURAP. The application forms are filled and submitted electronically on TRC website. Each of the proposals submitted to TRC is selected through a rigorous reviewing and screening process. Novelty and originality of the research idea is the most crucial element in writing a research proposal. Performing an in-depth review of the literature will assist you to compose a good researchable question and generate a strong hypothesis. The development of a good hypothesis will offer insight into the specific objectives of a study. Research objectives should be focused, measurable, and achievable by a specific time using the most appropriate methodology. Moreover, it is essential to select a proper study design in-line with the purpose of the study and the hypothesis. Furthermore, social/economic impact and reasonable budget of proposed research are important criteria in research proposal evaluation by TRC. Finally, ethical principles should be observed before writing a research proposal involving human or animal subjects.
Krishnan, Shekhar; Wade, Rachel; Moorman, Anthony V; Mitchell, Chris; Kinsey, Sally E; Eden, TOB; Parker, Catriona; Vora, Ajay; Richards, Sue; Saha, Vaskar
Despite the success of contemporary treatment protocols in childhood acute lymphoblastic leukaemia (ALL), relapse within the central nervous system (CNS) remains a challenge. To better understand this phenomenon, we have analysed the changes in incidence and pattern of CNS relapses in 5564 children enrolled on four successive MRC-ALL trials between 1985 and 2001. Changes in the incidence and pattern of CNS relapses were examined and the relationship with patient characteristics assessed. Factors affecting post-relapse outcome were determined. Overall, relapses declined by 49%. Decreases occurred primarily in non-CNS and combined relapses with a progressive shift towards later (≥30 months from diagnosis) relapses (p<0·0001). Although isolated CNS relapses declined, the proportional incidence and timing of relapse remained unchanged. Age and presenting white cell count were risk factors for CNS relapse. On multivariate analysis, the time to relapse and the trial period influenced post-relapse outcomes. Relapse trends differed within biological subtypes. In ETV6-RUNX1 ALL, relapse patterns mirrored overall trends while in High Hyperdiploidy ALL, these appear to have plateaued over the latter two trial periods. Intensive systemic and intrathecal chemotherapy have decreased the overall CNS relapse rates and changed the patterns of recurrence. The heterogeneity of therapeutic response in the biological subtypes suggests room for further optimisation using currently available chemotherapy. PMID:20016529
Information about NCI programs and initiatives that sponsor, conduct, develop, or support clinical trials, including NCI’s Clinical Trial Network (NCTN) and NCI Community Oncology Research Program (NCORP) initiatives.
Rollo Moore, A.; Jim Warrington, A.P.; Aird, Edwin G.A.; Margaret Bidmead, A.; Dearnaley, David P.
Within the UK RT01 trial the MRC also funded a quality assurance (QA) programme. This included a planning and dosimetry audit at participating centres using a purpose built phantom. Geometrical setup was visually assessed via field shaping around the phantom GTV (to within the order of 1 mm). Within the phantom, ion chamber positional uncertainties were estimated as 0.6 mm (95% CL, k = 2). This was the basis for ion chamber measurements in a variety of dose gradients around the PTV closely simulating a patient case. The design provides a representative but reproducible system for QA in the prostate radiotherapy process, from CT scan to treatment. Setup errors are not eliminated, but minimised and estimated
A Comparison of Outcomes Following Laparoscopic and Open Hysterectomy With or Without Lymphadenectomy for Presumed Early-Stage Endometrial Cancer: Results From the Medical Research Council ASTEC Trial.
Kyrgiou, Maria; Swart, Anne-Marie; Qian, Wendi; Warwick, Jane
Laparoscopic hysterectomy (LH) is increasingly used for the management of endometrial malignancy. Its benefits may be particularly pronounced as these women are more likely to be older or obese. The aim of this study was to determine whether outcomes for LH are comparable to the open hysterectomy (OH). This was a prospective cohort study nested within the multicenter ASTEC (A Study in the Treatment of Endometrial Cancer) randomized controlled trial (1998-2005). Women with presumed early endometrial cancer were included. Laparoscopic hysterectomy was compared with OH with or without systematic lymphadenectomy. Overall survival, time to first recurrence, complication rates, and surgical outcomes were the main outcome measures. Of 1408 women, 1309 (93%) received OH, and 99 (7%) had LH. LH was associated with longer operating time (median, LH 105 minutes [interquartile range (IQR), 60-150] vs OH 80 minutes [IQR, 60-95]; P < 0.001) but 50% shorter hospital stay (median, LH 4 days [IQR, 3-5] vs OH 6 days [IQR, 5-7]). The number of harvested lymph nodes was similar (median, LH 13 [IQR, 10-16] vs OH 12 [IQR, 11-13]; P = 0.67). LH had fewer intraoperative and postoperative adverse events (9% difference, LH 21% vs OH 30%; borderline significance; P = 0.07). The rate of conversion to laparotomy for the LH group was high (27%). The median follow-up was 37 months. After adjusting for significant prognostic factors, the hazard ratio for overall survival in those who underwent LH compared with those who underwent OH was 0.67 (95% confidence interval, 0.31-1.43) (P = 0.30). Laparoscopic hysterectomy for early endometrial cancer is safe. Although it requires longer operating time it is associated with shorter hospital stay and favorable morbidity profile. Further studies are required to assess the long-term safety.
The Advisory Council for Health Research (RGO) advised the Dutch Minister of Health on research into the epidemiology, prevention and research of antibiotic resistance in the Netherlands. Good antimicrobial practice, insight into antibiotic use, implementation of measures to prevent development of
As part of the lead up to the October 2000 International Conference on Health Research for Development in Bangkok, the Council on Health Research for Development (COHRED) called upon its associates around the world to reflect on achievements and setbacks in the 1990s. This book is the result of those reflections.
ca/index_eng.asp. International Research Initiative on Adaptation to Climate Change. The International Research Initiative on Adaptation to Climate Change aims to help vulnerable populations in Canada and in developing countries adapt to ...
The initiative's activities include training, regional exchanges and forums, online training, on-site coaching, and collaborative research. The initiative was developed jointly by IDRC, the United Kingdom's Department for International Development, and South Africa's National Research Foundation. Its ultimate goal is ...
Five senior physicists have written to the UK science minister, Lord Drayson, about the "dismal future" for researchers in the country in the wake of a £40m shortfall in the budget of the Science and Technology Facilities Council (STFC). The physicists, who chair the STFC's five advisory panels, have also called for structural reforms to be made to the council. They warn that unless the government takes action to reverse the situation, the UK will be "perceived as an untrustworthy partner in global projects" and predict that a brain drain of the best UK scientists to positions overseas will ensue.
Vanhoutte, Els Karla; Faber, Catharina Gerritdina; van Nes, Sonja Ingrid; Jacobs, Bart Casper; van Doorn, Pieter Antoon; van Koningsveld, Rinske; Cornblath, David Reid; van der Kooi, Anneke Jelly; Cats, Elisabeth Aviva; van den Berg, Leonard Hendrik; Notermans, Nicolette Claudia; van der Pol, Willem Lodewijk; Hermans, Mieke Catharina Elisabeth; van der Beek, Nadine Anna Maria Elisabeth; Gorson, Kenneth Craig; Eurelings, Marijke; Engelsman, Jeroen; Boot, Hendrik; Meijer, Ronaldus Jacobus; Lauria, Giuseppe; Tennant, Alan; Merkies, Ingemar Sergio José; Barreira, A. A.; Bennett, D.; van den Bergh, P. Y. K.; Bril, V.; Devigili, G.; Hadden, R. D.; Hahn, A. F.; Hartung, H.-P.; Hughes, R. A. C.; Illa, I.; Katzberg, H.; Léger, J.-M.; Lewis, R. A.; Lunn, M. P. T.; Nascimento, O. J. M.; Nobile-Orazio, E.; Padua, L.; Pouget, J.; Reilly, M. M.; van Schaik, I.; Smith, B.; de Visser, M.; Walk, D.
The Medical Research Council grading system has served through decades for the evaluation of muscle strength and has been recognized as a cardinal feature of daily neurological, rehabilitation and general medicine examination of patients, despite being respectfully criticized due to the unequal
E.K. Vanhoutte (Els); C.G. Faber (Carin); S.I. van Nes (Sonja); B.C. Jacobs (Bart); P.A. van Doorn (Pieter); R. van Koningsveld (Rinske); D.R. Cornblath (David); A.J. Kooj (Anneke); E.A. Cats (Elisabeth); L.H. van den Berg (Leonard); N.C. Notermans (Nicolette); W.L. van der Pol (Ludo); M.C.E. Hermans; N.A.M.E. van der Beek (Nadine); K.C. Gorson (Kenneth); M. Eurelings (Marijke); L. Engelsman (Lyda); H. Boot (Hendrik); R.J. Meijer (Ron); G. Lauria (Giuseppe); C. Tennant (Christopher); I.S.J. Merkies (Ingemar)
textabstractThe Medical Research Council grading system has served through decades for the evaluation of muscle strength and has been recognized as a cardinal feature of daily neurological, rehabilitation and general medicine examination of patients, despite being respectfully criticized due to the
... DEPARTMENT OF VETERANS AFFAIRS National Research Advisory Council; Notice of Meeting The Department of Veterans Affairs (VA) gives notice under Public Law 92-463 (Federal Advisory Committee Act... Phoenix Park Hotel, Federal City Room, 520 North Capitol Street, NW., Washington, DC. The meeting will...
... Development, 1400 Independence Ave., SW., Washington, DC 20250-1120, or fax their names and proposed agenda... Deputy Chief for Research and Development, (202) 205-1665. Individuals who use telecommunication devices for the deaf (TDD) may call the Federal Information Relay Service (FIRS) at 1-800-877-8339 between 8 a...
Goldstein, Richard J.
The Engineering Research Program, a component program of the DOE Office of Basic Energy Sciences (BES), was established in 1979 to aid in resolving the numerous engineering issues arising from efforts to meet U.S. energy needs. The major product of the program became part of the body of knowledge and data upon which the applied energy technologies are founded; the product is knowledge relevant to energy exploration, production, conversion and use.
Berners-Lee, Tim; De Roure, Dave; Harnad, Stevan; Shadbolt, Nigel
The Research Councils of the UK (RCUK) propose to require that the authors of all journal articles resulting from RCUK-funded research must make them openly accessible by self-archiving them on the web in order maximise their usage and impact. ALPSP (Association of Learned and Professional Society Publishers) claim that this will have a negative effect on journals, but the only evidence they provide fails to support their claim and all existing evidence is to the contrary: Journal publication...
We at the Research Councils believe that there are many aspects of society and business that could be transformed by the innovative design and use of digital technologies. This has led to the Digital Economy Programme. The Digital Economy is an RCUK Cross-Research Council Programme, led by the EPSRC, but working closely with ESRC, MRC, AHRC and TSB. What is Digital Economy? Digital Economy is the novel design or use of information and communication technology to help transform the lives of individuals, society or business. All Digital Economy research involves the user community. This can include industry, government, society, charities or other groups as applicable. The research will understand the technologies and also why change is needed, what the impacts will be and who will benefit. Research in this cross-research council area can be driven by economic, social or technical need. The early involvement of the user community is vital if new technologies are to be integrated successfully into business opportunities, technical solutions or commercial products and processes. Challenges in the Digital Economy will require multi-disciplinary academic input, including, but not limited to, the arts and humanities, economic and social sciences and medical sciences, in addition to engineering and physical sciences.
This final Annual Report of the Science and Engineering Research Council (SERC) covers the work of the organization for 1993-1994 and explains the structures and missions of the organizations which replace it. SERC funds and supports United Kingdom research programs covering many aspects of science and engineering. Its work will be split between the new Engineering and Physical Sciences Research Council, the Particle Physics and Astronomy Research Council, the Biotechnology and Biological Sciences Research Council and the Natural Environment Research Council. Research achievements and training initiatives are reported for each of SERC's current Boards. (UK)
Rydin, Claudia Alves de Jesus; Farina Busto, Luis; Penny, Martin
Women have historically been underrepresented in science. Much positive progress in attracting women to research careers has been achieved in recent years; however, the most influential and high profile positions in most countries are still predominantly occupied by men. The European Research Council (ERC), Europe's premiere funding agency for frontier research, views gender equality as an important challenge. The ERC monitors closely gender figures on every call and has taken actions to tackle gender imbalances and potential unconscious biases. The ERC talk is focused on efforts made to understand and ensure equal treatment of all candidates, with particular focus on gender balance and with specific attention to geosciences. Data and statistics collected from ERC's internationally recognised funding schemes are presented.
Randomized trial on the efficacy of radiotherapy for cerebral low-grade glioma in the adult: European Organization for Research and Treatment of Cancer Study 22845 with the Medical Research Council study BRO4: an interim analysis
Karim, Abul B.M.F.; Afra, Denes; Cornu, Philippe; Bleehan, Norman; Schraub, Simon; De Witte, Olivier; Darcel, Francois; Stenning, Sally; Pierart, Marianne; Van Glabbeke, Martine
Purpose: There is no consensus on the treatment strategy for adult patients with cerebral low-grade glioma. The diagnosis and primary treatment are usually undertaken by surgery. Some investigators doubt the efficacy of postoperative radiotherapy (RT), whereas others advise routine postoperative RT. We report the primary results of a multicenter randomized trial on this controversy. Methods and Materials: From 24 European centers, 311 adult patients with low-grade glioma were randomized centrally after surgery from March 1986 through September 1997, between the two arms of the trial. The irradiated group received 54 Gy in 6 weeks. The other patients did not receive any treatment after surgery until the tumor showed progression, defined as clinical-neurologic deterioration and evidence of progressive tumor on imaging. Results: Of 290 eligible and assessable patients (93%), the irradiated group showed a significant (log-rank p = 0.02) improvement in time to progression but not in overall survival, with a median follow-up of 5 years. The 5-year estimate was, respectively, 63% vs. 66% (overall survival) and 44% vs. 37% (time to progression) for the treated and control arms. Different treatment modalities, including RT, were undertaken for the 85 controls when a progressive tumor was noted. Conclusion: Early postoperative conventional RT such as that used for this protocol appears to improve the time to progression or progression-free survival, but not overall survival, for patients with low-grade glioma
... Propane Education and Research Council's Operations, Market Changes and Federal Programs AGENCY... Education and Research Council (PERC), in conjunction with the cumulative effects of market changes and... requirements under the Propane Education and Research Act of 1996 that established PERC and requires the...
A randomized controlled trial investigating the effect of Pycnogenol and Bacopa CDRI08 herbal medicines on cognitive, cardiovascular, and biochemical functioning in cognitively healthy elderly people: the Australian Research Council Longevity Intervention (ARCLI study protocol (ANZCTR12611000487910
Stough Con K
Full Text Available Abstract Background One of the major challenges associated with our ageing population is the increasing incidence of age-associated cognitive decline, which has significant implications for an individual's ability to lead a productive and fulfilling life. In pure economic terms the costs of ageing reflects decreased productivity and engagement with the workforce. The maintenance of brain health underpinning intact cognition is a key factor to maintaining a positive, engaged, and productive lifestyle. In light of this, the role of diet, including supplementation with nutritional and even pharmacological interventions capable of ameliorating the neurocognitive changes that occur with age constitute vital areas of research. Methods In order to reduce cognitive ageing, the ARC longevity intervention (ARCLI was developed to examine the effects of two promising natural pharmacologically active supplements on cognitive performance. ARCLI is a randomized, placebo-controlled, double-blind, 3-arm clinical trial in which 465 participants will be randomized to receive an extract of Bacopa monnieri (CDRI08 300 mg/day, Pycnogenol (150 mg/day, or placebo daily for 12 months. Participants will be tested at baseline and then at 3, 6 and 12 months post-randomization on a wide battery of cognitive, neuropsychological and mood measures, cardiovascular (brachial and aortic systolic and diastolic blood pressures as well as arterial stiffness, biochemical (assays to measure inflammation, oxidative stress and safety as well as genetic assessments (telomere length and several Single Nucleotide Polymorphisms. The primary aim is to investigate the effects of these supplements on cognitive performance. The secondary aims are to explore the time-course of cognitive enhancement as well as potential cardiovascular and biochemical mechanisms underpinning cognitive enhancement over the 12 months of administration. ARCLI will represent one of the largest and most comprehensive
... DEPARTMENT OF TRANSPORTATION Bureau of Transportation Statistics Research and Innovative Technology Administration Advisory Council on Transportation Statistics; Notice of Meeting AGENCY: Research... Transportation, Research and Innovative Technology Administration, Bureau of Transportation Statistics, Attention...
Mirra, Nicole; Morrell, Ernest D.; Cain, Ebony; Scorza, D'Artagnan; Ford, Arlene
This article explores civic learning, civic participation, and the development of civic agency within the Council of Youth Research (the Council), a program that engages high school students in youth participatory action research projects that challenge school inequalities and mobilize others in pursuit of educational justice. We critique the…
The EPRI/Alberta Research Council Clean Soil Process can remove hydrocarbon contamination from waste material from manufactured gas plants. The process uses coal as an absorbent to remove hydrocarbons. For petroleum contaminated soils, the process can bring residual concentration of petroleum below 0.1 percent and polycyclic aromatic hydrocarbon (PAH) concentration to 1--5 ppM. For coal tar contaminated soils, the process can reduce tar concentrations to about 0.05-0.5 percent and the PAH concentration to about 10--60 ppM. Additional post-treatment may be required for some precleaned soils. The process yields by-product agglomerates suitable for combustion in industrial boilers. Light hydrocarbons such as benzene are vaporized from the soil, condensed and collected in the Process and disposed of off-site. The Clean Soil Process has been tested at pilot-plant scale. A conceptual design for a 200-tons-per-day plant yielded a capital cost estimated at $3.1 million with a per-ton operating cost of $40
O'Cathain, Alicia; Thomas, Kate J; Drabble, Sarah J; Rudolph, Anne; Goode, Jackie; Hewison, Jenny
Researchers sometimes undertake qualitative research with randomised controlled trials (RCTs) of health interventions. To systematically explore how qualitative research is being used with trials and identify ways of maximising its value to the trial aim of providing evidence of effectiveness of health interventions. A sequential mixed methods study with four components. (1) Database search of peer-reviewed journals between January 2008 and September 2010 for articles reporting the qualitative research undertaken with specific trials, (2) systematic search of database of registered trials to identify studies combining qualitative research and trials, (3) survey of 200 lead investigators of trials with no apparent qualitative research and (4) semistructured telephone interviews with 18 researchers purposively sampled from the first three methods. Qualitative research was undertaken with at least 12% of trials. A large number of articles reporting qualitative research undertaken with trials (n=296) were published between 2008 and 2010. A total of 28% (82/296) of articles reported qualitative research undertaken at the pre-trial stage and around one-quarter concerned drugs or devices. The articles focused on 22 aspects of the trial within five broad categories. Some focused on more than one aspect of the trial, totalling 356 examples. The qualitative research focused on the intervention being trialled (71%, 254/356), the design and conduct of the trial (15%, 54/356), the outcomes of the trial (1%, 5/356), the measures used in the trial (3%, 10/356), and the health condition in the trial (9%, 33/356). The potential value of the qualitative research to the trial endeavour included improving the external validity of trials and facilitating interpretation of trial findings. This value could be maximised by using qualitative research more at the pre-trial stage and reporting findings with explicit attention to the implications for the trial endeavour. During interviews
... NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice (10-112)] NASA Advisory Council; Planetary Science Subcommittee; Supporting Research and Technology Working Group; Meeting AGENCY: National... announces a meeting of the Supporting Research and Technology Working Group of the Planetary Science...
On December 8, 1986, the Committee on Nuclear Safety Research of the National Research Council submitted its report, ''Revitalizing Nuclear Safety Research,'' to the US Nuclear Regulatory Commission (NRC). The Commission and its staff have carefully reviewed the Committee's report and have extensively examined the planning, implementation, and management of NRC research programs in order to respond most effectively to the Committee's recommendations. This report presents the Commission's view of the Committee's report and describes the actions that are under way in response to its recommendations
Details of expenditure and reports of the activities of the four Boards which operate as the Science and Engineering Research Council are given. These are the Astronomical and Planetry Science Board, the Engineering Board, the Nuclear Physics Board and the Science Board. There is also a report on the optical physics and optoelectronic research supported by the Council. Committee membership, studentship, fellowships research grants and administration details are reported. (UK)
Leadbetter, A.; Callaghan, S.; Lowry, R.; Moncoiffé, G.; Donnegan, S.; Pepler, S.; Cunningham, N.; Kirsch, P.; Ault, L.; Bell, P.; Bowie, R.; Harrison, K.; Smith-Haddon, B.; Wetherby, A.; Wright, D.; Thorley, M.
The Natural Environment Research Council (NERC) is implementing its Science Information Strategy in order to provide a world class service to deliver integrated data for earth system science. One project within this strategy is Data Citation and Publication, which aims to put the promotion and recognition stages of the data lifecycle into place alongside the traditional data management activities of NERC's Environmental Data Centres (EDCs). The NERC EDCs have made a distinction between the serving of data and its publication. Data serving is defined in this case as the day-to-day data management tasks of: • acquiring data and metadata from the originating scientists; • metadata and format harmonisation prior to database ingestion; • ensuring the metadata is adequate and accurate and that the data are available in appropriate file formats; • and making the data available for interested parties. Whereas publication: • requires the assignment of a digital object identifier to a dataset which guarantees that an EDC has assessed the quality of the metadata and the file format and will maintain an unchanged version of the data for the foreseeable future • requires the peer-review of the scientific quality of the data by a scientist with knowledge of the scientific domain in which the data were collected, using a framework for peer-review of datasets such as that developed by the CLADDIER project. • requires collaboration with journal publishers who have access to a well established peer-review system The first of these requirements can be managed in-house by the EDCs, while the remainder require collaboration with the wider scientific and publishing communities. It is anticipated that a scientist may achieve a lower level of academic credit for a dataset which is assigned a DOI but does not follow through to the scientific peer-review stage, similar to publication in a report or other non-peer reviewed publication normally described as grey literature, or
Children are at risk of HIV infection, stand to benefit from the development of HIV preventive vaccines, and therefore should be enrolled in trials of HIV vaccines in order to generate relevant safety, immunogenicity and efficacy data. In. South Africa, the national vaccine initiative is considering the future conduct of trials ...
Korkegi, R. H.
The results of a National Research Council study on the effect that advances in computational fluid dynamics (CFD) will have on conventional aeronautical ground testing are reported. Current CFD capabilities include the depiction of linearized inviscid flows and a boundary layer, initial use of Euler coordinates using supercomputers to automatically generate a grid, research and development on Reynolds-averaged Navier-Stokes (N-S) equations, and preliminary research on solutions to the full N-S equations. Improvements in the range of CFD usage is dependent on the development of more powerful supercomputers, exceeding even the projected abilities of the NASA Numerical Aerodynamic Simulator (1 BFLOP/sec). Full representation of the Re-averaged N-S equations will require over one million grid points, a computing level predicted to be available in 15 yr. Present capabilities allow identification of data anomalies, confirmation of data accuracy, and adequateness of model design in wind tunnel trials. Account can be taken of the wall effects and the Re in any flight regime during simulation. CFD can actually be more accurate than instrumented tests, since all points in a flow can be modeled with CFD, while they cannot all be monitored with instrumentation in a wind tunnel.
Day, Jennifer; Lindauer, Cathleen; Parks, Joyce; Scala, Elizabeth
The objective of this descriptive qualitative study was to identify best practices of nursing research councils (NRCs) at Magnet®-designated hospitals. Nursing research (NR) is essential, adding to the body of nursing knowledge. Applying NR to the bedside improves care, enhances patient safety, and is an imperative for nursing leaders. We interviewed NR designees at 26 Magnet-recognized hospitals about the structure and function of their NRCs and used structural coding to identify best practices. Most organizations link NR and evidence-based practice. Council membership includes leadership and clinical nurses. Councils conduct scientific reviews for nursing studies, supporting nurse principal investigators. Tracking and reporting of NR vary widely and are challenging. Councils provide education, sponsor research days, and collaborate interprofessionally, including with academic partners. Findings from this study demonstrate the need to create formal processes to track and report NR and to develop outcome-focused NR education.
Martinez-Garza, Mario; Clark, Douglas B.; Nelson, Brian C.
This review synthesises research on digital games and science learning as it supports the goals for science proficiency outlined in the report by the US National Research Council on science education reform. The review is organised in terms of these research-based goals for science proficiency in light of their alignment with current science…
Basques, Eric O. [National Academy of Sciences, Washington, DC (United States)
This report summarizes work carried out over the period from July 5, 2005-January 31, 2014. The work was carried out by the National Research Council Research Associateships Program of the National Academies, under the US Department of Energy's National Energy Technology Laboratory (NETL) program. This Technical Report consists of a description of activity from 2005 through 2014, broken out within yearly timeframes, for NRC/NETL Associateships researchers at NETL laboratories which includes individual tenure reports from Associates over this time period. The report also includes individual tenure reports from associates over this time period. The report also includes descriptions of program promotion efforts, a breakdown of the review competitions, awards offered, and Associate's activities during their tenure.
Moore, G.F.; Audrey, S.; Barker, M.; Bond, L.; Bonell, C.; Hardeman, W.; Moore, L.; O'Cathain, A.; Tinati, T.; Wight, D.; Baird, J.
Attempts to tackle problems such as smoking and obesity increasingly use complex interventions. These are commonly defined as interventions that comprise multiple interacting components, although additional dimensions of complexity include the difficulty of their implementation and the number of organisational levels they target.1 Randomised controlled trials are regarded as the gold standard for establishing the effectiveness of interventions, when randomisation is feasible. However, effect ...
The CSIR undertakes and manages broadly based scientific research, development and technology transfer in South Africa. The organisation is divided into four groups: Corporate Finance Management; Research Development and Implementation; Foundation for Research Development and Corporate Support Services. Research on coal is carried out by the Energy Technology Division which is part of the Research, Development and Implementation Group. This annual report reviews the work of the CSIR during 1987.
Conway, Patrick H
The American Recovery and Reinvestment Act of 2009 provided $1.1 billion for comparative effectiveness research and established the Federal Coordinating Council for Comparative Effectiveness Research to direct that investment. The council laid a critical foundation for comparative effectiveness research in the steps it took to gather information, invite public input, set priorities, coordinate project solicitations, and stress the importance of evaluating research investments. Although the council has been superseded by a successor--the Patient-Centered Outcomes Research Institute--the experiences of the council can and should inform the work of the new institute as it begins its operations.
van der Meulen, Barend
Research councils have mediated the principal-agent relation between government and science: they are expected to mediate the political and policy interests in scientific research into the world of science and technology and promote the interests of science and technology in the policy world.
Bal Krishna Joshi
Full Text Available Agricultural research findings are required to reach soon to the farmers, extensionists, media, researchers, policy makers, businessperson, students, teachers and so many other stakeholders. Among different types of publications, research paper is generally published in journal considered as standard type of publication in term of quality and recognition. Most of the journals follow similar pattern and framework; however, the style, format and process may be different with each other. A research (scientific paper is a written describing original research result using standard methods and materials. The major sections in a journal paper are abstract, introduction, materials and methods, results, discussion, conclusion, and references. Accordingly Journal of Nepal Agricultural Research Council has its own style and format. Author needs to follow guidelines strictly on the use of punctuation marks such as comma (,, period (., space, justification etc; otherwise submitted manuscripts could be immediately return to author without considering in review process. In general, we received manuscripts with many errors on citation and references, poor elaboration of results of experiments, weak discussion, missing to acknowledge funding agencies, submitting non-editable figures, very few numbers of citations of Nepalese researchers, statements not in logical order, etc. In general, the scientific papers should be written in simple way with new but sufficient justification backed up by data in the form of tables, graphs, flow diagrams etc so that readers can understand easily with high readability. The submitted manuscript in the journal office are sent to two to three reviewers for specific recommendation on the originality of the work, appropriateness of the approach and experimental design, adequacy of experimental techniques, soundness of conclusions and interpretations, relevance of discussion and importance of the research. The language clarity and
This report covers the activities of the Geotechnical Board and its two national committees, the US National Committee for Rock Mechanics (USNC/RM) and the US National Committee on Tunneling Technology (USNC/TT), for the period from March 1, 1991 to June 30, 1992. The report covers a 16-month period, through June of this year, to bring the reporting period in line with the National Research Council`s (NRC) fiscal year. Subsequent reports will cover the 12-month period July 1--June 30, unless individual contracts require otherwise. A description of the Geotechnical Board and its committees within the context of the National Academy of Sciences/National Research Council, as well as lists of current members of the board and national committees can be found in Attachment A.
Conclusion: The quality and quantity of vascular surgery research in the GCC countries should be improved to answer important local questions related to vascular diseases. This needs better strategic planning and more collaboration between various institutions.
The paper presents the Annual Report of the Science and Engineering Research Council (SERC), United Kingdom 1987/8. The contents contains the reports of the four Boards of the Council - the Astronomy and Planetary Science Board, the Engineering Board, the Nuclear Physics Board and the Science Board. The SERC report also contains eleven review articles on major advances in Science in recent years, including high temperature superconductivity and the supernova in the Large Magellanic Cloud, as well as details of fourteen ''highlights'' of 1987/8 including the dating of the Turin Shroud. (U.K.)
Wilkening, Dean A.
This chapter explains and summarizes the main findings of a recent National Research Council study entitled Making Sense of Ballistic Missile Defense: An Assessment of Concepts and Systems for U.S. Boost-Phase Missile Defense in Comparison to Other Alternatives.
Peter Warry has been appointed as Chair of PPARC for the next 4 years. Chairman of Victrex plc, whose business is in speciality chemicals, he has been an Industrial Professor at the University of Warwick since 1993. PPARC pursues a programme of high quality basic research in particle physics, astronomy, cosmology and space science and its budget for 2002 is approximately 220 million GBP.
Pausch, Randy; Aviles, Walter; Durlach, Nathaniel; Robinett, Warren; Zyda, Michael
In 1992, at the request of a consortium of federal agencies, the National Research Council established a committee to "recommand a national research and development agenda in the area of virtual reality" to set U.S. government R&D funding priorities for virtual reality (VR) for the next decade....
@@ Introduction The Medical Research Foundation is the Medical Research Council's (MRC) independently managed charity.It receives funds from the giving public to support medical research, training, public engagement and dissemination of knowledge.Since it was first established in 1920, the MRC has been able to accept charitable bequests, endowments and donations from the public to contribute towards the costs of the research that it undertakes.The MRC registered these charitable funds with the Charity Commission in the late 1960's and its charity - the Medical Research Foundation-has been successfully supporting medical research for over 80 years.
This twenty-fifth anniversary issue of the Science and Engineering Research Council's (SERC) Annual Report opens by reemphasizing the continuing need to plan research expenditure on a greater than annual basis. Exciting developments in every branch and discipline continue to emerge. This year has seen advances in public relations for SERC with the plans for a science centre on the Royal Observatory, Edinburgh site, and a national essay competition for school children. (UK)
Manley, P. L.; Ambos, E. L.
Undergraduate research (UR) is one of the most authentic and effective ways to promote student learning, and is a high-impact educational practice that can lead to measurable gains in student retention and graduation rates, as well as career aspirations. In recent years, UR has expanded from intensive summer one-on-one faculty-student mentored experiences to application in a variety of educational settings, including large lower division courses. The Council on Undergraduate Research (CUR), founded in 1978, is a national organization of individual (8000) and institutional members (650) within a divisional structure that includes geosciences, as well as 10 other thematic areas. CUR's main mission is to support and promote high-quality undergraduate student-faculty collaborative research and scholarship that develops learning through research. CUR fulfills this mission through extensive publication offerings, faculty and student-directed professional development events, and outreach and advocacy activities that share successful models and strategies for establishing, institutionalizing, and sustaining undergraduate research programs. Over the last decade, CUR has worked with hundreds of academic institutions, including two-year colleges, to develop practices to build undergraduate research into campus cultures and operations. As documented in CUR publications such as Characteristics of Excellence in Undergraduate Research (COEUR), strategies institutions may adopt to enhance and sustain UR often include: (1) the establishment of a central UR campus office, (2) extensive student and faculty participation in campus-based, as well as regional UR celebration events, (3) development of a consistent practice of assessment of UR's impact on student success, and, (4) establishment of clear policies for recognizing and rewarding faculty engagement in UR, particularly with respect to mentorship and publication with student scholars. Three areas of current focus within the
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A recent report by the National Research Council raised a number of important issues that will have an impact on nuclear engineering departments across the country. The report has been reviewed in the context of its relevance to the Department of Nuclear Engineering at the University of Michigan (UM), and some observations and conclusions have been drawn. This paper focuses on those portions of Ref. 1 concerning undergraduate and graduate curricula, research facilities and laboratories, faculty research interests, and funding for research and graduate student support because these topics have a direct impact on current and future directions for the department
The report of the National Research Council (NRC), Physics through the 1990s, highlights past developments and research opportunities in the various subfields of physics and addresses general issues concerning the present state of the discipline in the United States. At the request of the Secretary of Energy, the Energy Research Advisory Board (ERAB) reviewed this report and identified the areas that relate to the programs and objectives of the Department of Energy (DOE). The present report provides the conclusions of this review and the recommendations for the Department's actions
In March, 1955, the Prime Minister requested that the Medical Research Council should appoint an independent committee to report on the medical and genetic aspects of nuclear radiation and in the following month the Council appointed us members of such a committee, under the chairmanship of Sir Harold Himsworth, to undertake this task. In June, 1956, our Report to the Medical Research Council (Cmd. 9780) was presented to Parliament by the Lord President of the Council. In the following months our Genetics Panel met twice for the primary purpose of putting forward further recommendations for research and in June, 1958, we ourselves, at the Council's request, met again in full session to prepare a statement (Cmnd. 508) on the Report of the United Nations Scientific Committee on the Effects of Atomic Radiation. During the whole of this period the subject has been kept under regular review by various standing committees of the Council. We ourselves met again in November, 1959, following a request from the Medical Research Council that we should prepare a further considered statement of the position in this field and the report which follows is the result of this request.
In March, 1955, the Prime Minister requested that the Medical Research Council should appoint an independent committee to report on the medical and genetic aspects of nuclear radiation and in the following month the Council appointed us members of such a committee, under the chairmanship of Sir Harold Himsworth, to undertake this task. In June, 1956, our Report to the Medical Research Council (Cmd. 9780) was presented to Parliament by the Lord President of the Council. In the following months our Genetics Panel met twice for the primary purpose of putting forward further recommendations for research and in June, 1958, we ourselves, at the Council's request, met again in full session to prepare a statement (Cmnd. 508) on the Report of the United Nations Scientific Committee on the Effects of Atomic Radiation. During the whole of this period the subject has been kept under regular review by various standing committees of the Council. We ourselves met again in November, 1959, following a request from the Medical Research Council that we should prepare a further considered statement of the position in this field and the report which follows is the result of this request
Rydin, Claudia Alves de Jesus; Farina Busto, Luis; El Mjiyad, Nadia; Kota, Jhansi; Thelen, Lionel
The European Research Council (ERC), Europe's premiere funding agency for frontier research, views equality of opportunities as an important challenge. The ERC monitors closely gender figures on every call and has taken actions to tackle imbalances and potential unconscious biases. The ERC talk is focused on efforts made to understand and ensure equal treatment of all candidates, with particular focus on gender balance and with specific attention to geosciences. Data and statistics collected in running highly competitive and internationally recognised funding schemes are presented. Recent initiatives to tackle geographical imbalances will also be presented.
Duchesne, Gillian M.
Full text: From 2004-2009 a total of 226 out of a target of 750 prostate cancer patients have been randomised into the Timing of Androgen Deprivation trial between immediate and delayed androgen deprivation. A screening log was kept by participating centres for the first 928 patients, which documented the reasons for non-entry into the trial; 42.7% of screened patients were ineligible and a further 33.0% were not entered for other reasons. Fewer than 10% of patients cited not wanting to be part of a clinical trial as a reason for non-entry. Strategies to improve recruitment included broadening the eligibility criteria, encouraging international collaboration, the use and support of research nurses in the private health care environment, and the use of phone follow-up. Recruitment will be completed at the number originally intended to inform the interim analysis designed to test the validity of the statistical assumptions, and a combined survival analysis with the Canadian study is planned.
Hickey, Jason E; Pryjmachuk, Steven; Waterman, Heather
Rapid growth and development in recent decades has seen mental health and mental illness emerge as priority health concerns for the Gulf Cooperation Council (Bahrain, Kuwait, Oman, Qatar, Saudi Arabia, and the United Arab Emirates). As a result, mental health services in the region are being redefined and expanded. However, there is a paucity of local research to guide ongoing service development. Local research is important because service users' experience of mental illness and mental health services are linked to their sociocultural context. In order for service development to be most effective, there is a need for increased understanding of the people who use these services.This article aims to review and synthesize mental health research from the Gulf Cooperation Council. It also seeks to identify gaps in the literature and suggest directions for future research. A scoping framework was used to conduct this review. To identify studies, database searches were undertaken, regional journals were hand-searched, and reference lists of included articles were examined. Empirical studies undertaken in the Gulf Cooperation Council that reported mental health service users' experience of mental illness were included. Framework analysis was used to synthesize results. Fifty-five studies met inclusion criteria and the following themes were identified: service preferences, illness (symptomology, perceived cause, impact), and recovery (traditional healing, family support, religion). Gaps included contradictory findings related to the supportive role of the Arabic extended family and religion, under-representation of women in study samples, and limited attention on illness management outside of the hospital setting.From this review, it is clear that the sociocultural context in the region is linked to service users' experience of mental illness. Future research that aims to fill the identified gaps and develop and test culturally appropriate interventions will aid practice
The Alberta Research Council (ARC) develops and commercializes technologies to give its clients a competitive advantage. It carries out applied R and D on a contract or fee basis, and co-ventures with others to develop new technologies, deriving a return on investment from the commercialization of new products and services. ARC carries out research in the following sectors: 1) agriculture and biotechnology; 2) energy: conventional and heavy oil recovery and production technologies, reservoir management processes and protocols, novel downhole oilfield equipment, speciality sensors and instrumentation, and upgrading technologies for improved recovery and cost efficiency; and as well industrial processes and technologies related to water and land management and climate change to ensure sustainable development; 3) forestry; 4) environment: research to comprehend and mitigate the impact of industrial activities on air, water and land resources, including climate change, greenhouse gases and carbon dioxide management strategies; clean process and waste minimization technologies; and advanced environmental analyses and toxicology
Arvay, C A
Over the years, clinical trials with their structured treatment plans and multicenter involvement have been instrumental in developing new treatments and establishing standard of care therapy. While clinical trials strive to advance medical knowledge, they provide scientifically sound, state of the art care and their use should be increased. The Brain Tumor Cooperative Group, one such NCI-sponsored cooperative group, has been the primary group for the treatment of malignant gliomas. As the field of neuro-oncology expands, the neuroscience nurse needs to develop an understanding of clinical trials and their operation. The nurse is in an optimal position to support medical research and the research participant.
Roberts, S.; Glickson, D.; Mengelt, C.; Forrest, S.; Waddell, K.
The National Research Council is a private, nonprofit organization chartered by Congress in 1916 as an expansion of the U.S. National Academy of Sciences. Its mission is to improve the use of science in government decision making and public policy, increase public understanding, and promote the acquisition and dissemination of knowledge in matters involving science, engineering, technology, and health. Within the National Research Council, the Ocean Studies Board (OSB) mission is to explore the science, policies, and infrastructure needed to understand, manage, and conserve coastal and marine environments and resources. OSB undertakes studies and workshops on emerging scientific and policy issues at the request of federal agencies, Congress, and others; provides program reviews and guidance; and facilitates communication on oceanographic issues among different sectors. OSB also serves as the U.S. National Committee to the international, nongovernmental Scientific Committee on Oceanic Research (SCOR). OSB has produced reports on a wide range of topics of interest to researchers and educators, the federal government, the non-profit sector, and industry. Recent reports have focused on ecosystem services in the Gulf of Mexico after the Deepwater Horizon oil spill, sea level rise on the U.S. west coast, scientific ocean drilling needs and accomplishments, requirements for sustained ocean color measurements, critical infrastructure for ocean research, tsunami warning and preparedness, ocean acidification, and marine and hydrokinetic power resource assessments. Studies that are currently underway include responding to oil spills in the Arctic, evaluating the effectiveness of fishery stock rebuilding plans, and reviewing the National Ocean Acidification Research Plan. OSB plays an important role in helping create policy decisions and disseminating important information regarding various aspects of ocean science.
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Fox, L. K.; Guertin, L. A.; Manley, P. L.; Fortner, S. K.
Undergraduate research is a proven effective pedagogy that has a number of benefits including: enhancing student learning through mentoring relationships with faculty; increasing retention; increasing enrollment in graduate programs; developing critical thinking, creativity, problem solving and intellectual independence; and, developing an understanding of research methodology. Undergraduate research also has been demonstrated in preparing students for careers. In addition to developing disciplinary and technical expertise, participation in undergraduate research helps students improve communication skills (written, oral, and graphical) and time management. Early involvement in undergraduate research improves retention and, for those engaged at the 2YC level, helps students successfully transfers to 4YC. The Geosciences Division of the Council on Undergraduate Research (GeoCUR) supports faculty in their development of undergraduate research programs at all levels. GeoCUR leads workshops for new and future faculty covering all aspects of undergraduate research including incorporating research into coursework, project design, mentoring students, sustaining programs, and funding sources. GeoCUR members support new faculty by providing a range of services including: peer-review of grant proposals; advice on establishing an undergraduate research program; balancing teaching and research demands; and networking with other geoscientist. GeoCUR has also developed web resources that support faculty and departments in development of undergraduate research programs (http://serc.carleton.edu/NAGTWorkshops/undergraduate_research/index.html). This presentation will describe the services provided by GeoCUR and highlight examples of programs and resources available to geoscientists in all career stages for effective undergraduate research mentoring and development.
Narendra K Arora
Full Text Available In India, research prioritization in Maternal, Newborn, and Child Health and Nutrition (MNCHN themes has traditionally involved only a handful of experts mostly from major cities. The Indian Council of Medical Research (ICMR-INCLEN collaboration undertook a nationwide exercise engaging faculty from 256 institutions to identify top research priorities in the MNCHN themes for 2016-2025. The Child Health and Nutrition Research Initiative method of priority setting was adapted. The context of the exercise was defined by a National Steering Group (NSG and guided by four Thematic Research Subcommittees. Research ideas were pooled from 498 experts located in different parts of India, iteratively consolidated into research options, scored by 893 experts against five pre-defined criteria (answerability, relevance, equity, investment and innovation and weighed by a larger reference group. Ranked lists of priorities were generated for each of the four themes at national and three subnational (regional levels [Empowered Action Group & North-Eastern States, Southern and Western States, & Northern States (including West Bengal]. Research priorities differed between regions and from overall national priorities. Delivery domain of research which included implementation research constituted about 70 per cent of the top ten research options under all four themes. The results were endorsed in the NSG meeting. There was unanimity that the research priorities should be considered by different governmental and non-governmental agencies for investment with prioritization on implementation research and issues cutting across themes.
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Kaleebu, P; Kamali, A; Seeley, J; Elliott, A M; Katongole-Mbidde, E
For the past 25 years, the Medical Research Council/Uganda Virus Research Institute Uganda Research Unit on AIDS has conducted research on HIV-1, coinfections and, more recently, on non-communicable diseases. Working with various partners, the research findings of the Unit have contributed to the understanding and control of the HIV epidemic both in Uganda and globally, and informed the future development of biomedical HIV interventions, health policy and practice. In this report, as we celebrate our silver jubilee, we describe some of these achievements and the Unit's multidisciplinary approach to research. We also discuss the future direction of the Unit; an exemplar of a partnership that has been largely funded from the north but led in the south. © 2014 The Authors. Tropical Medicine & International Health Published by John Wiley & Sons Ltd.
The report covers the year to March 31 1987. The expenditure of the Council over the year is given. Highlights of the year are summarized -these include laser holography, supercomputers and aerodynamic design, achievements in the Alvey programme, the compact synchrotron X-ray source, observation of the w-boson decay, results form Giotto, fish farming and genetic fingerprinting. Reports of the four boards -astronomy and planetary science, engineering, nuclear physics and science -are presented. Twelve articles then review major advances in recent years. These include the UK at CERN, scanning tunnelling microscopy, recent research using synchrotron x radiation, the European X-ray observatory EXOSAT and global solar oscillations. (U.K.)
Gatz, Margaret; Harris, Jennifer R.; Kaprio, Jaakko; McGue, Matt; Smith, Nicholas L.; Snieder, Harold; Spiro, Avron; Butler, David A.
The National Academy of Sciences-National Research Council Twin Registry (NAS-NRC Twin Registry) is a comprehensive registry of White male twin pairs born in the USA between 1917 and 1927, both of the twins having served in the military. The purpose was medical research and ultimately improved
Nieschlag, Eberhard; Kumar, Narender; Sitruk-Ware, Régine
Testosterone is an essential part of all regimens for hormonal male contraception tested to date. Initial efficacy trials revealed that the half-life of the testosterone preparations available at that time was too short to be used for male contraception. The ensuing search for long-acting preparations yielded testosterone buciclate and undecanoate as well as 7α-methyl-19-nortestosterone (MENT). Following description of the principle of male hormonal contraception and the efficacy trials performed to date, the systematic development of MENT for substitution of male hypogonadism and use in male contraception by the Population Council is reviewed here. Copyright © 2013. Published by Elsevier Inc.
Plétan, Yannick; Zannad, Faïez; Jaillon, Patrice
Be it to restore the confused image of clinical research in relation to the lay public, or to develop new ways of accruing healthy volunteers or patients for clinical trials, there is a need to draft some guidance on how best to provide information on research. Although the French legal and regulatory armamentarium in this area is essentially liberal, there is currently little-justified reluctance among study sponsors to advertise publicly. A group of academic and pharmaceutical industry researchers, assembled for a workshop, together with regulators, journalists, representatives from ethics committees, social security, patient and health consumer groups and other French institutional bodies, has suggested the following series of recommendations: there is no need for additional legal or regulatory constraints; sponsors should be aware of and make use of direct public information on trials; a 'good practice charter' on public communication about clinical trials should be developed; all professionals should be involved in this communication platform; communication in the patient's immediate vicinity should be preferred (primary-care physician, local press); clinical databases and websites accessible to professionals, but also to patients and non-professionals, should be developed; genuine instruction on clinical trials for physicians and health professionals unfamiliar with such trials should be developed and disseminated; media groups should receive at least some training in the fundamentals of clinical research.
In 1957, the leading British asbestos companies (Turner & Newall, Cape Asbestos, and British Belting & Asbestos) founded the Asbestosis Research Council (ARC). This was a response to rising asbestosis and asbestos cancer mortality in the UK and the attendant political and social problems that threatened the existence of the asbestos industry. An ARC research program was launched, that by the 1970s was mainly based within the Institute of Occupational Medicine at Edinburgh University. By the end of the 1980s, well over a hundred papers had been published with ARC support. The bulk of the work involved animal experiments and the chemical analysis of fibers, but the asbestos companies showed little enthusiasm for wider epidemiological studies or for exploring the cancer threat. The sponsoring companies dictated the ARC's research strategy and also vetted (and sometimes censored) publications; while using the ARC as a counterweight to government regulation and media attacks. The ARC's history highlights the compromises that were made by individual scientists and demonstrates the dilemmas inherent in industry-controlled research. Copyright 2000 Wiley-Liss, Inc.
De Silva, Mary J; Breuer, Erica; Lee, Lucy; Asher, Laura; Chowdhary, Neerja; Lund, Crick; Patel, Vikram
The Medical Research Councils' framework for complex interventions has been criticized for not including theory-driven approaches to evaluation. Although the framework does include broad guidance on the use of theory, it contains little practical guidance for implementers and there have been calls to develop a more comprehensive approach. A prospective, theory-driven process of intervention design and evaluation is required to develop complex healthcare interventions which are more likely to be effective, sustainable and scalable. We propose a theory-driven approach to the design and evaluation of complex interventions by adapting and integrating a programmatic design and evaluation tool, Theory of Change (ToC), into the MRC framework for complex interventions. We provide a guide to what ToC is, how to construct one, and how to integrate its use into research projects seeking to design, implement and evaluate complex interventions using the MRC framework. We test this approach by using ToC within two randomized controlled trials and one non-randomized evaluation of complex interventions. Our application of ToC in three research projects has shown that ToC can strengthen key stages of the MRC framework. It can aid the development of interventions by providing a framework for enhanced stakeholder engagement and by explicitly designing an intervention that is embedded in the local context. For the feasibility and piloting stage, ToC enables the systematic identification of knowledge gaps to generate research questions that strengthen intervention design. ToC may improve the evaluation of interventions by providing a comprehensive set of indicators to evaluate all stages of the causal pathway through which an intervention achieves impact, combining evaluations of intervention effectiveness with detailed process evaluations into one theoretical framework. Incorporating a ToC approach into the MRC framework holds promise for improving the design and evaluation of complex
Pontoppidan, Maiken; Keilow, Maria; Dietrichson, Jens
of this paper is to examine the history of randomised controlled trials in Scandinavian compulsory schools (grades 0–10; pupil ages 6-15). Specifically, we investigate drivers and barriers for randomised controlled trials in educational research and the differences between the three Scandinavian countries...... crucial for the implementation of RCTs and are likely more important in smaller countries such as the Scandinavian ones. Supporting institutions have now been established in all three countries, and we believe that the use of RCTs in Scandinavian educational research is likely to continue....... or more interventions were randomly assigned to groups of students and carried out in a school setting with the primary aim of improving the academic performance of children aged 6-15 in grades 0–10 in Denmark, Norway, or Sweden. We included both conducted and ongoing trials. Publications that seemed...
The paper lists the references of publications resulting from the Neutron Beam Scattering Programme supported by the Science and Engineering Research Council, covering the year 1984, but also including publications from 1983 not given in the previous issue of this listing. (author)
Research conducted by the British Council concerning modern continuous professional development of teachers has been analyzed. The issue concerning foreign language teachers' professional development has been considered. Productive approach to this process that gives a teacher the opportunities to define aspects of their professional activities…
Complete text of publication follows. The astrophysical p-process, the production mechanism of the heavy proton rich isotopes (the so-called p-nuclei) is still one of the least understood processes of nucleosynthesis. The modeling of the process requires a huge network of thousands of reactions where the rates of the involved reactions represent one of the biggest uncertainty in the resulting abundances of p-nuclei. In lack of experimental data the required reaction rates are taken from statistical model calculations which proved to be inaccurate in the mass and energy range relevant for the p-process. The systematic experimental study of the relevant reactions is therefore crucial to test the calculated reaction rates, to select the best input parameters for the calculations and, consequently, to contribute to a better understanding of the astrophysical p-process. The European Research Council (ERC) has acknowledged this need for experimental data when they decided to support a project devoted to this subject. In 2007 the first call of the ERC Frontier Research Scheme (Starting Grants) has been launched within the FP7 Specific Programme 'IDEAS'. From the very high number of applications, the peer reviewers of the ERC Scientific Council has recommended for funding the proposal entitled 'Nuclear reaction studies relevant to the astrophysical p-process nucleosynthesis'. An amount of 750,000 Euro has been allocated to the project for a 5 year duration. The starting date of the project was 1st July, 2008. With the ERC support, an extensive experimental study of the p-process is being carried out. The experiments will be carried out almost exclusively with the accelerators of the ATOMKI. The financial support allows to largely improve the available experimental technique. The purchase of two large volume HPGe detectors is in progress as a result of a public procurement. The upgrade of the nuclear electronics and data acquisition system used for p-process related
Maira, Javier; Etxabe, Javier; Serena, Pedro A
Nanoscience and nanotechnology made their appearance in the scientific scene at a time when both the economy of Spain and the Spanish Research and Innovation System were experiencing strong growth. This circumstance resulted in a remarkable development of nanoscience and nanotechnology especially in universities and public research institutions such as the Spanish National Research Council (Consejo Superior de Investigaciones Científicas-CSIC). However, this development in academia has not been reflected in a similar increment in the transfer of knowledge to the productive sector despite several efforts and initiatives were launched. The CSIC, the main generator of scientific knowledge in Spain, has designed and implemented a series of actions in order to take advantage of the knowledge generated in nanotechnology by its research groups by mean of an appropriate transfer to both the Spanish and the international industry. Internal methodologies used in CSIC in order to protect and commercialize nanotechnology based intellectual property as well as their effects are reviewed. The evolution of CSIC nanotechnology patents portfolio is also analyzed. There has been a clear increase in the patent license agreements of CSIC in the period 2002- 2015 in the field of nanotechnology. This increase is correlated to these facts: (i) Highly qualified team managing Intellectual Property issues, (ii) The presence of CSIC in international fairs, and (iii) Proactive search of companies and investors. Successful results can be achieved in technology transfer when the appropriate resources are available and properly organized with an adequate combination of efforts in knowledge protection, promotion and commercialization of technologies and support to the scientific entrepreneurs of the institution. Copyright© Bentham Science Publishers; For any queries, please email at firstname.lastname@example.org.
Jean Teillac (President of the Council) gives the speech. The occasion was the end-of-term of Leon Van Hove and John Adams as Research and Executive Director-General, respectively, to be succeeded by Herwig Schopper. The venue was the Hotel Beau-Rivage in Geneva. Beside Jean Teillac are (on the left) G.H. Stafford and Mme Van Hove, (on the right) Mme Schopper.
Brackney, Dana E; Lane, Susan Hayes; Dawson, Tyia; Koontz, Angie
This descriptive field study examines processes used to evaluate simulation for senior-level Bachelor of Science in Nursing (BSN) students in a capstone course, discusses challenges related to simulation evaluation, and reports the relationship between faculty evaluation of student performance and National Council Licensure Examination for Registered Nurses (NCLEX-RN) first-time passing rates. Researchers applied seven terms used to rank BSN student performance (n = 41, female, ages 22-24 years) in a senior-level capstone simulation. Faculty evaluation was correlated with students' NCLEX-RN outcomes. Students evaluated as "lacking confidence" and "flawed" were less likely to pass the NCLEX-RN on the first attempt. Faculty evaluation of capstone simulation performance provided additional evidence of student preparedness for practice in the RN role, as evidenced by the relationship between the faculty assessment and NCLEX-RN success. Simulation has been broadly accepted as a powerful educational tool that may also contribute to verification of student achievement of program outcomes and readiness for the RN role.
Steckelings, U. Muscha; de Mey, Jo G. R.; Pinto-Sietsma, Sara-Joan; Henrion, Daniel; Unger, Thomas
The 15th Annual Meeting of the European Council of Cardiovascular Research brought together basic and clinical scientists working in the cardiovascular field in La Colle sur Loup, France. Upfront basic and clinical research addressing the mechanisms of disease, identification of biomarkers or
Anderson, B. Harold
The purpose of the study reported in this document was to describe the quantitative and qualitative characteristics of the vocational teacher education programs among institutions that are members of the University Council for Vocational Education. A questionnaire was mailed to representatives of each member institution in October 1985, with a 100…
Full Text Available for Scien- tific and Industrial Research (CSIR), the Medical Research Council, Agricultural Research Council, Human Sciences Research Council, Council for Geosciences, Mintek, and the Nuclear Energy Corporation of SA. Legally, it includes the National... with social or commercial impact is long and uncer- tain, and becomes more and more expen- sive the closer the development gets to implementation. It is hard for a single organization to span this entire contin- uum effectively—it requires ‘interfacial...
Glickson, D.; Holmes, K. J.; Cooke, D.
Marine and hydrokinetic (MHK) resources are increasingly becoming part of energy regulatory, planning, and marketing activities in the U.S. and elsewhere. In particular, state-based renewable portfolio standards and federal production and investment tax credits have led to an increased interest in the possible deployment of MHK technologies. The Energy Policy Act of 2005 (Public Law 109-58) directed the Department of Energy (DOE) to estimate the size of the MHK resource base. In order to help DOE prioritize its overall portfolio of future research, increase the understanding of the potential for MHK resource development, and direct MHK device and/or project developers to locations of greatest promise, the DOE Wind and Water Power Program requested that the National Research Council (NRC) provide an evaluation of the detailed assessments being conducted by five individual resource assessment groups. These resource assessment groups were contracted to estimate the amount of extractable energy from wave, tidal, ocean current, ocean thermal energy conversion, and riverine resources. Performing these assessments requires that each resource assessment group estimate the average power density of the resource base, as well as the basic technology characteristics and spatial and temporal constituents that convert power into electricity for that resource. The NRC committee evaluated the methodologies, technologies, and assumptions associated with each of these resource assessments. The committee developed a conceptual framework for delineating the processes used to develop the assessment results requested by the DOE, with definitions of the theoretical, technical, and practical resource to clarify elements of the overall resource assessment process. This allowed the NRC committee to make a comparison of different methods, terminology, and processes among the five resource assessment groups. The committee concluded that the overall approach taken by the wave resource and
Shukla, Hari Shankar; Sirohi, Bhawna; Behari, Anu; Sharma, Atul; Majumdar, Jahar; Ganguly, Manomoy; Tewari, Mallika; Kumar, Sandeep; Saini, Sunil; Sahni, Peush; Singh, Tomcha; Kapoor, Vinay Kumar; Sucharita, V.; Kaur, Tanvir; Shukla, Deepak Kumar; Rath, Goura Kishor
EXECUTIVE SUMMARY The document is based on consensus among the experts and best available evidence pertaining to Indian population and is meant for practice in India.All postcholecystectomy gallbladder specimens should be opened and examined carefully by the operating surgeon and be sent for histopathological examination.All “incidental” gall bladder cancers (GBCs) picked up on histopathological examination should have an expert opinion.Evaluation of a patient with early GBC should include essential tests: A computed tomography (CT) scan (multi-detector or helical) of the abdomen and pelvis for staging with a CT chest or chest X-ray, and complete blood counts, renal and liver function tests. magnetic resonance imaging/positron emission tomography (PET)-CT are not recommended for all patients.For early stage disease (up to Stage IVA), surgery is recommended. The need for adjuvant treatment would be guided by the histopathological analysis of the resected specimen.Patients with Stage IVB/metastatic disease must be assessed for palliative e.g. endoscopic or radiological intervention, chemotherapy versus best supportive care on an individual basis. These patients do not require extensive workup outside of a clinical trial setting.There is an urgent need for multicenter trials from India covering various aspects of epidemiology (viz., identification of population at high-risk, organized follow-up), clinical management (viz., bile spill during surgery, excision of all port sites, adjuvant/neoadjuvant therapy) and basic research (viz., what causes GBC). PMID:26157282
Cooke, Jo; Bacigalupo, Ruth; Halladay, Linsay; Norwood, Hayley
The purpose of this study was to investigate the level of research activity, research use, research interests and research skills in the social care workforce in two UK councils with social service responsibilities (CSSRs). A cross-sectional survey was conducted of the social care workforce in two CSSRs (n = 1512) in 2005. The sample was identified in partnership with the councils, and included employees with professional qualifications (social workers and occupational therapists); staff who have a role to assess, plan and monitor care; service managers; commissioners of services; and those involved with social care policy, information management and training. The survey achieved a response rate of 24% (n = 368). The Internet was reported as an effective source of research information; conversely, research-based guidelines were reported to have a low impact on practice. Significant differences were found in research use, by work location, and postgraduate training. Most respondents saw research as useful for practice (69%), and wanted to collaborate in research (68%), but only 11% were planning to do research within the next 12 months. Having a master's degree was associated with a greater desire to lead or collaborate in research. A range of research training needs, and the preferred modes of delivery were identified. Support to increase research activity includes protected time and mentorship. The study concludes that a range of mechanisms to make research available for the social care workforce needs to be in place to support evidence-informed practice. Continual professional development to a postgraduate level supports the use and production of evidence in the social care workforce, and promotes the development of a research culture. The term research is used to include service user consultations, needs assessment and service evaluation. The findings highlight a relatively large body of the social care workforce willing to collaborate and conduct research
Roberts, S. J.; Feeley, M. H.
With the increasing stress on ocean and coastal resources, ocean resource management will require greater capacity in terms of people, institutions, technology and tools. Successful capacity-building efforts address the needs of a specific locale or region and include plans to maintain and expand capacity after the project ends. In 2008, the US National Research Council published a report that assesses past and current capacity-building efforts to identify barriers to effective management of coastal and marine resources. The report recommends ways that governments and organizations can strengthen marine conservation and management capacity. Capacity building programs instill the tools, knowledge, skills, and attitudes that address: ecosystem function and change; processes of governance that influence societal and ecosystem change; and assembling and managing interdisciplinary teams. Programs require efforts beyond traditional sector-by-sector planning because marine ecosystems range from the open ocean to coastal waters and land use practices. Collaboration among sectors, scaling from local community-based management to international ocean policies, and ranging from inland to offshore areas, will be required to establish coordinated and efficient governance of ocean and coastal ecosystems. Barriers Most capacity building activities have been initiated to address particular issues such as overfishing or coral reef degradation, or they target a particular region or country facing threats to their marine resources. This fragmentation inhibits the sharing of information and experience and makes it more difficult to design and implement management approaches at appropriate scales. Additional barriers that have limited the effectiveness of capacity building programs include: lack of an adequate needs assessment prior to program design and implementation; exclusion of targeted populations in decision- making efforts; mismanagement, corruption, or both; incomplete or
The research councils discovered in December the allocation of money from the UK government's Comprehensive Spending Review, and have set out their delivery plans outlining how they will spend it. Details and decisions will follow consultation in the coming months. The first image from eMerlin, the UK's national radio astronomy facility, shows the power of the enhanced network of radio telescopes spread over 220 km and now linked by fibre optics. These links and advanced receivers will allow astronomers to see in a single day what would have previously taken them more than a year of observations.
Methods. The Medical Research Council (MRC) HIV Prevention Research ... which uses fingerprint-based biometric technology to identify participants. ... and clinical trial sites, with new participant information loaded at first visit to a trial site.
Steckelings, U Muscha; De Mey, Jo G R; Pinto-Sietsma, Sara-Joan; Henrion, Daniel; Unger, Thomas
The 15th Annual Meeting of the European Council of Cardiovascular Research brought together basic and clinical scientists working in the cardiovascular field in La Colle sur Loup, France. Upfront basic and clinical research addressing the mechanisms of disease, identification of biomarkers or development of new treatments was communicated in 101 presentations, 35 of them as a part of five on-topic oral sessions and three workshops. Three keynote lectures reviewed current knowledge and the latest data about mechanosensitive channels in pressure regulation, cell therapy in cardiovascular disease and mechanisms of cardiovascular risk associated with diabetic nephropathy. This article summarizes highlights of the oral sessions, workshops and keynote lectures.
Background Qualitative research methods are increasingly used within clinical trials to address broader research questions than can be addressed by quantitative methods alone. These methods enable health professionals, service users, and other stakeholders to contribute their views and experiences to evaluation of healthcare treatments, interventions, or policies, and influence the design of trials. Qualitative data often contribute information that is better able to reform policy or influence design. Methods Health services researchers, including trialists, clinicians, and qualitative researchers, worked collaboratively to develop a comprehensive portfolio of standard operating procedures (SOPs) for the West Wales Organisation for Rigorous Trials in Health (WWORTH), a clinical trials unit (CTU) at Swansea University, which has recently achieved registration with the UK Clinical Research Collaboration (UKCRC). Although the UKCRC requires a total of 25 SOPs from registered CTUs, WWORTH chose to add an additional qualitative-methods SOP (QM-SOP). Results The qualitative methods SOP (QM-SOP) defines good practice in designing and implementing qualitative components of trials, while allowing flexibility of approach and method. Its basic principles are that: qualitative researchers should be contributors from the start of trials with qualitative potential; the qualitative component should have clear aims; and the main study publication should report on the qualitative component. Conclusions We recommend that CTUs consider developing a QM-SOP to enhance the conduct of quantitative trials by adding qualitative data and analysis. We judge that this improves the value of quantitative trials, and contributes to the future development of multi-method trials. PMID:23433341
Singh, Surya K; Patel, Vivek H; Gupta, Balram
The mainstay of diagnosis of osteoporosis is dual-energy X-ray absorptiometry (DXA) scan measuring areal bone mineral density (BMD) (g/cm 2 ). The aim of the present study was to compare the Indian Council of Medical Research database (ICMRD) and the Lunar ethnic reference database of DXA scans in the diagnosis of osteoporosis in male patients. In this retrospective study, all male patients who underwent a DXA scan were included. The areal BMD (g/cm 2 ) was measured at either the lumbar spine (L1-L4) or the total hip using the Lunar DXA machine (software version 8.50) manufactured by GE Medical Systems (Shanghai, China). The Indian Council of Medical Research published a reference data for BMD in the Indian population derived from the population-based study conducted in healthy Indian individuals, which was used to analyze the BMD result by Lunar DXA scan. The 2 results were compared for various values using statistical software SPSS for Windows (version 16; SPSS Inc., Chicago, IL). A total 238 male patients with a mean age of 57.2 yr (standard deviation ±15.9) were included. Overall, 26.4% (66/250) and 2.8% (7/250) of the subjects were classified in the osteoporosis group according to the Lunar database and the ICMRD, respectively. Out of the 250 sites of the DXA scan, 28.8% (19/66) and 60.0% (40/66) of the cases classified as osteoporosis by the Lunar database were reclassified as normal and osteopenia by ICMRD, respectively. In conclusion, the Indian Council of Medical Research data underestimated the degree of osteoporosis in male subjects that might result in deferring of treatment. In view of the discrepancy, the decision on the treatment of osteoporosis should be based on the multiple fracture risk factors and less reliably on the BMD T-score. Copyright © 2017 The International Society for Clinical Densitometry. Published by Elsevier Inc. All rights reserved.
Lord, Stephen R; Delbaere, Kim; Tiedemann, Anne; Smith, Stuart T; Sturnieks, Daina L
Preventing falls and fall-related injuries among older people is an urgent public health challenge. This paper provides an overview of the background to and research planned for a 5-year National Health and Medical Research Council Partnership Grant on implementing falls prevention research findings into policy and practice. This program represents a partnership between key Australian falls prevention researchers, policy makers and information technology companies which aims to: (1) fill gaps in evidence relating to the prevention of falls in older people, involving new research studies of risk factor assessment and interventions for falls prevention; (2) translate evidence into policy and practice, examining the usefulness of new risk-identification tools in clinical practice; and (3) disseminate evidence to health professionals working with older people, via presentations, new evidence-based guidelines, improved resources and learning tools, to improve the workforce capacity to prevent falls and associated injuries in the future.
Gibb, Herman; Haver, Cary; Gaylor, David; Ramasamy, Santhini; Lee, Janice S.; Lobdell, Danelle; Wade, Timothy; Chen, Chao; White, Paul; Sams, Reeder
Objective The purpose of this review is to evaluate the impact of recent epidemiologic literature on the National Research Council (NRC) assessment of the lung and bladder cancer risks from ingesting low concentrations (ecologic nature of the Taiwanese studies on which the NRC estimates are based present certain limitations, the data from these studies have particular strengths in that they describe lung and bladder cancer risks resulting from lifetime exposure in a large population and remain the best data on which to conduct quantitative risk assessment. Continued follow-up of a population in northeastern Taiwan, however, offers the best opportunity to improve the cancer risk assessment for arsenic in drinking water. Future studies of arsenic < 100 μg/L in drinking water and lung and bladder cancer should consider adequacy of the sample size, the synergistic relationship of arsenic and smoking, duration of arsenic exposure, age when exposure began and ended, and histologic subtype. PMID:21030336
This article is part of an informational kit for teachers published by the New Zealand Council for Educational Research. The focus of this article is on the advantages and disadvantages of co-educational and single-sex secondary schools as discussed in research efforts from England and New Zealand. (JLL)
Ambos, E. L.; Havholm, K. G.; Malachowski, M.; Osborn, J.; Karukstis, K.
For more than seven years, the Council on Undergraduate Research (CUR), the primary organization supporting programs, services, and advocacy for undergraduate research, has been working with support from the NSF's Division of Undergraduate Education (DUE) to enhance, sustain, and institutionalize undergraduate research in diverse STEM disciplines and higher education settings. The Council on Undergraduate Research comprises more than 9000 individual and 670 institutional members within a divisional structure that includes geosciences, as well as 11 other thematic areas. Through its most recent grant: 'Transformational Learning through Undergraduate Research: Comprehensive Support for Faculty, Institutions, State Systems and Consortia' (NSF DUE CCLI III Award #09-20275), CUR has been collaborating with six higher education systems, each selected after a rigorous national application process in 2010 and 2011. These six systems, which collectively represent 79 individual institutions, are the Council of Public Liberal Arts Colleges (COPLAC), University of Wisconsin System (UWS), California State University System (CSU), City University of New York (CUNY), Great Lakes Colleges Association (GLCA), and Pennsylvania State System of Higher Education (PASSHE). The more than 350 participants of faculty and senior-level administrators from the six systems are engaged in shared multi-faceted and multi-year professional development experiences. Teams from each system attended customized institutes facilitated by CUR experts in 2011-2012, during which the teams developed specific action plans focused on institutionalizing undergraduate research on their campus and within their system. The systems were reconvened as a group a year after the first institute, to chart progress toward achieving their goals. Based on interviews and surveys with participants, campus teams are making substantial progress toward implementation of robust undergraduate research programs, and are making
Cooper, Cindy; O'Cathain, Alicia; Hind, Danny; Adamson, Joy; Lawton, Julia; Baird, Wendy
The value of using qualitative research within or alongside randomised controlled trials (RCTs) is becoming more widely accepted. Qualitative research may be conducted concurrently with pilot or full RCTs to understand the feasibility and acceptability of the interventions being tested, or to improve trial conduct. Clinical Trials Units (CTUs) in the United Kingdom (UK) manage large numbers of RCTs and, increasingly, manage the qualitative research or collaborate with qualitative researchers external to the CTU. CTUs are beginning to explicitly manage the process, for example, through the use of standard operating procedures for designing and implementing qualitative research with trials. We reviewed the experiences of two UK Clinical Research Collaboration (UKCRC) registered CTUs of conducting qualitative research concurrently with RCTs. Drawing on experiences gained from 15 studies, we identify the potential for the qualitative research to undermine the successful completion or scientific integrity of RCTs. We show that potential problems can arise from feedback of interim or final qualitative findings to members of the trial team or beyond, in particular reporting qualitative findings whilst the trial is on-going. The problems include: We make recommendations for improving the management of qualitative research within CTUs. Copyright © 2014. Published by Elsevier Inc.
... topics: --Overview of Research in Space Life and Physical Sciences --Space Station and Future Exploration... Exploration and Operations Committee; Research Subcommittee; Meeting AGENCY: National Aeronautics and Space... of the Research Subcommittee of the Human Exploration and Operations Committee (HEOC) of the NASA...
Educational Researcher, 2011
The Code of Ethics of the American Educational Research Association (AERA) articulates a common set of values upon which education researchers build their professional and scientific work. The Code is intended to provide both the principles and the rules to cover professional situations encountered by education researchers. It has as its primary…
... nomination packages to Daina Dravnieks Apple, Senior Staff Assistant, U.S. Forest Service; Research and... Dravnieks Apple, Senior Staff Assistant, U.S. Forest Service; Research and Development, Forestry Research... eligible institutions, and State agricultural experiment stations; and (4) Volunteer public groups...
Town of Cary, North Carolina — View the location of the Town of Cary’s four Town Council districts.Please note that one district, District A, is split into two geo-spatial areas. One area is in...
Rapport, Frances; Clement, Clare
BackgroundQualitative research methods are increasingly used within trials to address broader research questions than quantitative methods can address alone. Qualitative methods enable health professionals, service users and other stakeholders to contribute their views and experiences when evaluating health care treatments, interventions or policies. They can influence trial design, allowing for a fuller engagement with research questions, aims and objectives and clarify the complexities of p...
Flight, Laura; Julious, Steven A; Goodacre, Steve
Adaptive design clinical trials use preplanned interim analyses to determine whether studies should be stopped or modified before recruitment is complete. Emergency medicine trials are well suited to these designs as many have a short time to primary outcome relative to the length of recruitment. We hypothesised that the majority of published emergency medicine trials have the potential to use a simple adaptive trial design. We reviewed clinical trials published in three emergency medicine journals between January 2003 and December 2013. We determined the proportion that used an adaptive design as well as the proportion that could have used a simple adaptive design based on the time to primary outcome and length of recruitment. Only 19 of 188 trials included in the review were considered to have used an adaptive trial design. A total of 154/165 trials that were fixed in design had the potential to use an adaptive design. Currently, there seems to be limited uptake in the use of adaptive trial designs in emergency medicine despite their potential benefits to save time and resources. Failing to take advantage of adaptive designs could be costly to patients and research. It is recommended that where practical and logistical considerations allow, adaptive designs should be used for all emergency medicine clinical trials. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.
Maria Christina L. Oliveira
Full Text Available OBJECTIVE: To evaluate the profile and the scientific production of researchers in Pediatrics with scholarship from the National Counsel of Technological and Scientific Development. METHODS: The Lattes curricula of 34 researchers in Pediatrics with active scholarships, from 2006 to 2008 were included in the analysis. The variables of interest were: gender, affiliation, time since PHD, tutoring of undergraduate students, mentorship of masters and doctors, scientific production and the papers' impact. RESULTS: In a total of 411 researchers in Medicine, 34 (8% belonged to Pediatrics. Males (77% and scholars in the category 2 of productivity (62% prevailed. Three states of Brazil were responsible for approximately 90% of the researchers: São Paulo (53%, Minas Gerais (21%, and Rio Grande do Sul (15%. During their academic career, the Pediatrics researchers have published 3,122 articles with a median of 89 articles per researcher (interquartile range - IQ=51-119. Of the total, 40 and 59% articles were indexed in the Web of Science and Scopus databases, respectively. The Pediatrics researchers have published papers in 599 journals with a median impact factor of 2.35 (IQ=1.37-3.73 for the 323 indexed journals. CONCLUSIONS: The Pediatrics researchers have a relevant scientific output from the quantity point of the view, but there is a need to improve quality.
Oliveira, Maria Christina L; Martelli, Daniella Reis B; Pinheiro, Sergio Veloso; Miranda, Debora Marques; Quirino, Isabel Gomes; Leite, Barbara Gusmão L; Colosimo, Enrico Antonio; e Silva, Ana Cristina S; Martelli-Júnior, Hercílio; Oliveira, Eduardo Araujo
To evaluate the profile and the scientific production of researchers in Pediatrics with scholarship from the National Counsel of Technological and Scientific Development. The Lattes curricula of 34 researchers in Pediatrics with active scholarships, from 2006 to 2008 were included in the analysis. The variables of interest were: gender, affiliation, time since PHD, tutoring of undergraduate students, mentorship of masters and doctors, scientific production and the papers' impact. In a total of 411 researchers in Medicine, 34 (8%) belonged to Pediatrics. Males (77%) and scholars in the category 2 of productivity (62%) prevailed. Three states of Brazil were responsible for approximately 90% of the researchers: São Paulo (53%), Minas Gerais (21%), and Rio Grande do Sul (15%). During their academic career, the Pediatrics researchers have published 3,122 articles with a median of 89 articles per researcher (interquartile range - IQ=51-119). Of the total, 40 and 59% articles were indexed in the Web of Science and Scopus databases, respectively. The Pediatrics researchers have published papers in 599 journals with a median impact factor of 2.35 (IQ=1.37-3.73) for the 323 indexed journals. The Pediatrics researchers have a relevant scientific output from the quantity point of the view, but there is a need to improve quality.
Osterman, Linnéa; Masson, Isla
This study addresses a major gap in research and knowledge regarding female offenders' experiences of, and access to, restorative justice. The research was funded by Barrow Cadbury Trust and conducted with the support of the RJC, in association with Coventry University.
C. A. Caramori
Scientific development that has been achieved through decades finds in clinical research a great possibility of translating findings to human health application. Evidence given by clinical trials allows everyone to have access to the best health services. However, the millionaire world of pharmaceutical industries has stained clinical research with doubt and improbability. Study results (fruits of controlled clinical trials) and scientific publications (selective, manipulated and with wrong c...
C. A. Caramori
Full Text Available Scientific development that has been achieved through decades finds in clinical research a great possibility of translating findings to human health application. Evidence given by clinical trials allows everyone to have access to the best health services. However, the millionaire world of pharmaceutical industries has stained clinical research with doubt and improbability. Study results (fruits of controlled clinical trials and scientific publications (selective, manipulated and with wrong conclusions led to an inappropriate clinical practice, favoring the involved economic aspect. In 2005, the International Committee of Medical Journal Editors (ICMJE, supported by the World Association of Medical Editors, started demanding as a requisite for publication that all clinical trials be registered at the database ClinicalTrials.gov. In 2006, the World Health Organization (WHO created the International Clinical Trial Registry Platform (ICTRP, which gathers several registry centers from all over the world, and required that all researchers and pharmaceutical industries register clinical trials. Such obligatory registration has progressed and will extend to all scientific journals indexed in all worldwide databases. Registration of clinical trials means another step of clinical research towards transparency, ethics and impartiality, resulting in real evidence to the forthcoming changes in clinical practice as well as in the health situation.
Faibisoff, Sylvia G.
A major concern of the South Central Research Library Council in establishing an interlibrary loan network was the development of a Coordinated Delivery system (CODE). Several means of delivery were considered--the U.S. mails, commercial trucking (Greyhound, United Parcel Service), and use of the public library system's delivery services. A…
O'Keeffe, Lisa; O'Halloran, Kay L.; Wignell, Peter; Tan, Sabine
In 2015, the Australian Council for Educational Research (ACER) was tasked with developing literacy and numeracy skills testing for pre-service teachers. All undergraduate and postgraduate trainee teachers are now required to pass these literacy and numeracy tests at some stage on their journey to becoming a teacher; for commencing students from…
... welcome new members and discuss the timeline for the 2014 recommendations. The subcommittees will discuss... harness ``big data'' to address Alzheimer's research. DATES: The meeting will be held on October 28, 2013... welcome new members and discuss the timeline for the 2014 recommendations. The subcommittees will discuss...
Moore, Julia E.; Grouchy, Michelle; Graham, Ian D.; Shandling, Maureen; Doyle, Winnie; Straus, Sharon E.
Despite evidence on what works in healthcare, there is a significant gap in the time it takes to bring research into practice. The Council of Academic Hospitals of Ontario's Adopting Research to Improve Care program addresses this research-to-practice gap by incorporating the following components into its funding program: strategic selection of evidence for implementation, education and training for implementation, implementation supports, executive champions and governance, and evaluation. F...
Richard J . Tither Mobil Oil Corporation Sam D. Vallas Amoco Oil Company Douglas A. Voss Chevron Research Company Andy Vukovic Shell Canada Dave G...Instrumentation, * Preparation a Test Fuels: Procurement of Fuels and Cans, and Coordina- tion of On-Site Handling e Data Handling and Analysis j 2 nI |S 0- B-2 V...Doug McCorkell Union Oil Company of California James D. Merritt Amoco Oil Company Michael J . Mlotkowski Mobil Oil Corporation John Pandosh Sun Tech
D. A. Lestari
Full Text Available This study aimed to compare local dairy farmer ration formula with national research council in producing higher feed efficiency and milk production. This study had two stages. The first stage was in vitro study of dairy farmer rations which have different raw materials (R3, R4, and R5 with NRC based ration (R2 and Demo Farm ration (R1. The variables measured in this stage were proximate composition, volatile fatty acid, ammonia, dry matter and organic matter digestibility. The first stage used a randomized block design with five treatments, three groups of ruminal fluid, and three replications. The second stage used nine lactating cows with three periods of lactation (one, three, and other and used a randomized block design with three treatments, three groups, and one replication. Parameters measured were dry matter intake, manure score, milk production, body weight gain, body condition score, and technical and economical efficiencies. The first stage result showed that R1, R2, and R3 were three best rations in nutrient composition and fermentability (ammonia and volatile fatty acid concentrations were optimum for microbial growth and high digestibility, so in conclusion those three rations were the best rations and should be compared by in vivo method. The result of the second stage showed that all tested rations were not significantly different in milk production, performance and efficiency, so in conclusion those three rations have the same quality.
Gardener, Samantha L; Rainey-Smith, Stephanie R; Macaulay, S Lance; Taddei, Kevin; Rembach, Alan; Maruff, Paul; Ellis, Kathryn A; Masters, Colin L; Rowe, Christopher C; Ames, David; Keogh, Jennifer B; Martins, Ralph N
FFQ are commonly used to examine the association between diet and disease. They are the most practical method for usual dietary data collection as they are relatively inexpensive and easy to administer. In Australia, the Cancer Council of Victoria FFQ (CCVFFQ) version 2 and the online Commonwealth Scientific and Industrial Research Organisation FFQ (CSIROFFQ) are used. The aim of our study was to establish the level of agreement between nutrient intakes captured using the online CSIROFFQ and the paper-based CCVFFQ. The CCVFFQ and the online CSIROFFQ were completed by 136 healthy participants. FFQ responses were analysed to give g per d intake of a range of nutrients. Agreement between twenty-six nutrient intakes common to both FFQ was measured by a variety of methods. Nutrient intake levels that were significantly correlated between the two FFQ were carbohydrates, total fat, Na and MUFA. When assessing ranking of nutrients into quintiles, on average, 56 % of the participants (for all nutrients) were classified into the same or adjacent quintiles in both FFQ, with the highest percentage agreement for sugar. On average, 21 % of participants were grossly misclassified by three or four quintiles, with the highest percentage misclassification for fibre and Fe. Quintile agreement was similar to that reported by other studies, and we concluded that both FFQ are suitable tools for dividing participants' nutrient intake levels into high- and low-consumption groups. Use of either FFQ was not appropriate for obtaining accurate estimates of absolute nutrient intakes.
Lee, Chang-Hoon; Lee, Jinwoo; Park, Young Sik; Lee, Sang-Min; Yim, Jae-Joon; Kim, Young Whan; Han, Sung Koo; Yoo, Chul-Gyu
In assigning patients with chronic obstructive pulmonary disease (COPD) to subgroups according to the updated guidelines of the Global Initiative for Chronic Obstructive Lung Disease, discrepancies have been noted between the COPD assessment test (CAT) criteria and modified Medical Research Council (mMRC) criteria. We investigated the determinants of symptom and risk groups and sought to identify a better CAT criterion. This retrospective study included COPD patients seen between June 20, 2012, and December 5, 2012. The CAT score that can accurately predict an mMRC grade ≥ 2 versus COPD patients, the percentages of patients classified into subgroups A, B, C, and D were 24.5%, 47.2%, 4.2%, and 24.1% based on CAT criteria and 49.3%, 22.4%, 8.9%, and 19.4% based on mMRC criteria, respectively. More than 90% of the patients who met the mMRC criteria for the 'more symptoms group' also met the CAT criteria. AUROC and CART analyses suggested that a CAT score ≥ 15 predicted an mMRC grade ≥ 2 more accurately than the current CAT score criterion. During follow-up, patients with CAT scores of 10 to 14 did not have a different risk of exacerbation versus those with CAT scores COPD patients.
A survey of published and ongoing valuation research indicates that grid-connected photovoltaic (PV) technology is at or close to cost-effectiveness, from the utility or end-user point of view, in an increasing but carefully selected array of distributed utility applications. This conclusion is based on conventional analyses of utility avoided costs (energy, effective load carrying capability, and transmission and distribution costs including line losses) and customer benefits (energy and demand bill savings, tax benefits). It may provide the basis for regulatory review of utility transmission or distribution investments to test prudence or usefulness. The conclusion would be stronger with consideration of the values of risk mitigation, power quality, strategic value to utilities, and satisfaction of customer preference. Further work would therefore be useful in quantifying these factors. The economic conclusions prevail irrespective of the structure of the utility industry. However, the analysis is site-specific so its broad application depends on development of easily operated models and other analytical tools for use in the field and by the regulatory process
Bayramian, A.J.; Deri, R.J.; Erlandson, A.C.
Development of a new technology for commercial application can be significantly accelerated by leveraging related technologies used in other markets. Synergies across multiple application domains attract research and development (R and D) talent - widening the innovation pipeline - and increases the market demand in common components and subsystems to provide performance improvements and cost reductions. For these reasons, driver development plans for inertial fusion energy (IFE) should consider the non-fusion technology base that can be lveraged for application to IFE. At this time, two laser driver technologies are being proposed for IFE: solid-state lasers (SSLs) and KrF gas (excimer) lasers. This document provides a brief survey of organizations actively engaged in these technologies. This is intended to facilitate comparison of the opportunities for leveraging the larger technical community for IFE laser driver development. They have included tables that summarize the commercial organizations selling solid-state and KrF lasers, and a brief summary of organizations actively engaged in R and D on these technologies.
Haji, Faizal A; Da Silva, Celina; Daigle, Delton T; Dubrowski, Adam
Presently, health care simulation research is largely conducted on a study-by-study basis. Although such "project-based" research generates a plethora of evidence, it can be chaotic and contradictory. A move toward sustained, thematic, theory-based programs of research is necessary to advance knowledge in the field. Recognizing that simulation is a complex intervention, we present a framework for developing research programs in simulation-based education adapted from the Medical Research Council (MRC) guidance. This framework calls for an iterative approach to developing, refining, evaluating, and implementing simulation interventions. The adapted framework guidance emphasizes: (1) identification of theory and existing evidence; (2) modeling and piloting interventions to clarify active ingredients and identify mechanisms linking the context, intervention, and outcomes; and (3) evaluation of intervention processes and outcomes in both the laboratory and real-world setting. The proposed framework will aid simulation researchers in developing more robust interventions that optimize simulation-based education and advance our understanding of simulation pedagogy.
Research in Nursing Practice, Education, and Administration: Collaborative, Methodological, and Ethical Implications. Proceedings of the Research Conference of the Southern Council on Collegiate Education for Nursing (3rd, Baltimore, Maryland, December 2-3, 1983).
Strickland, Ora L., Ed.; Damrosch, Shirley P., Ed.
Collaborative research in nursing is discussed in five papers from the 1983 conference of the Southern Council on Collegiate Education for Nursing. Also included are 32 abstracts of nursing research, focusing on clinical practice, as well as nursing education and research models. Paper titles and authors are as follows: "Building a Climate…
May 2, 2016 ... Evidence-based practice (EBP) is positioned as an inherent good in the medical and clinical literature, and not without reason. It relies on the integration of research evidence, clinical expertise and patient preferences, and has become a foundation on which health systems are built and improved.
Dear, Rachel F; Barratt, Alexandra L; Crossing, Sally; Butow, Phyllis N; Hanson, Susan; Tattersall, Martin Hn
The Australian Cancer Trials website (ACTO) was publicly launched in 2010 to help people search for cancer clinical trials recruiting in Australia, provide information about clinical trials and assist with doctor-patient communication about trials. We describe consumer involvement in the design and development of ACTO and report our preliminary patient evaluation of the website. Consumers, led by Cancer Voices NSW, provided the impetus to develop the website. Consumer representative groups were consulted by the research team during the design and development of ACTO which combines a search engine, trial details, general information about trial participation and question prompt lists. Website use was analysed. A patient evaluation questionnaire was completed at one hospital, one week after exposure to the website. ACTO's main features and content reflect consumer input. In February 2011, it covered 1, 042 cancer trials. Since ACTO's public launch in November 2010, until the end of February 2011, the website has had 2, 549 new visits and generated 17, 833 page views. In a sub-study of 47 patient users, 89% found the website helpful for learning about clinical trials and all respondents thought patients should have access to ACTO. The development of ACTO is an example of consumers working with doctors, researchers and policy makers to improve the information available to people whose lives are affected by cancer and to help them participate in their treatment decisions, including consideration of clinical trial enrolment. Consumer input has ensured that the website is informative, targets consumer priorities and is user-friendly. ACTO serves as a model for other health conditions.
Butow Phyllis N
Full Text Available Abstract Background The Australian Cancer Trials website (ACTO was publicly launched in 2010 to help people search for cancer clinical trials recruiting in Australia, provide information about clinical trials and assist with doctor-patient communication about trials. We describe consumer involvement in the design and development of ACTO and report our preliminary patient evaluation of the website. Methods Consumers, led by Cancer Voices NSW, provided the impetus to develop the website. Consumer representative groups were consulted by the research team during the design and development of ACTO which combines a search engine, trial details, general information about trial participation and question prompt lists. Website use was analysed. A patient evaluation questionnaire was completed at one hospital, one week after exposure to the website. Results ACTO's main features and content reflect consumer input. In February 2011, it covered 1, 042 cancer trials. Since ACTO's public launch in November 2010, until the end of February 2011, the website has had 2, 549 new visits and generated 17, 833 page views. In a sub-study of 47 patient users, 89% found the website helpful for learning about clinical trials and all respondents thought patients should have access to ACTO. Conclusions The development of ACTO is an example of consumers working with doctors, researchers and policy makers to improve the information available to people whose lives are affected by cancer and to help them participate in their treatment decisions, including consideration of clinical trial enrolment. Consumer input has ensured that the website is informative, targets consumer priorities and is user-friendly. ACTO serves as a model for other health conditions.
From face, 1st raw: Erich Lohrmann, Sergio Fubini, Léon Van Hove, John Adams (Directors-General), Paul Levaux (President of the Council) Hans-Otto Wüster, Franco Bonaudi, Robert Lévy-Mandel and 2nd raw, centre: Patrick Mollet, Eliane de Modzelewska, Jean-Marie Dufour
Dolor, Rowena J.; Schmit, Kristine M.; Graham, Deborah G.; Fox, Chester H.; Baldwin, Laura Mae
Background There is increased interest nationally in multicenter clinical trials to answer questions about clinical effectiveness, comparative effectiveness, and safety in real-world community settings. Primary care practice-based research networks (PBRNs), comprising community- and/or academically affiliated practices committed to improving medical care for a range of health problems, offer ideal settings for these trials, especially pragmatic clinical trials. However, many researchers are not familiar with working with PBRNs. Methods Experts in practice-based research identified solutions to challenges that researchers and PBRN personnel experience when collaborating on clinical trials in PBRNs. These were organized as frequently asked questions in a draft document presented at a 2013 Agency for Health care Research and Quality PBRN conference workshop, revised based on participant feedback, then shared with additional experts from the DARTNet Institute, Clinical Translational Science Award PBRN, and North American Primary Care Research Group PBRN workgroups for further input and modification. Results The “Toolkit for Developing and Conducting Multi-site Clinical Trials in Practice-Based Research Networks” offers guidance in the areas of recruiting and engaging practices, budgeting, project management, and communication, as well as templates and examples of tools important in developing and conducting clinical trials. Conclusion Ensuring the successful development and conduct of clinical trials in PBRNs requires a highly collaborative approach between academic research and PBRN teams. PMID:25381071
Nugent, Allison C; Miller, Franklin G; Henter, Ioline D; Zarate, Carlos A
Mood disorders, including major depressive disorder (MDD) and bipolar disorder (BD), are highly prevalent, frequently disabling, and sometimes deadly. Additional research and more effective medications are desperately needed, but clinical trials research in mood disorders is fraught with ethical issues. Although many authors have discussed these issues, most do so from a theoretical viewpoint. This manuscript uses available empirical data to inform a discussion of the primary ethical issues raised in mood disorders research. These include issues of consent and decision-making capacity, including patients' motivations for participating in research. We also address drug withdrawals, placebo controls, and the overall safety of research. Finally, we examine the extant literature for studies discussing potential indirect benefits of clinical trials research to participants. Taken together, the evidence suggests that clinical trials research incorporating drug withdrawals and placebo controls can be conducted safely and ethically, even in patients with severe or treatment-resistant mood disorders. In fact, given the dearth of effective treatment options for this population, it is our opinion that a moral imperative exists to extend the offer of research participation to severely ill or treatment-resistant groups. Published 2017. This article is a U.S. Government work and is in the public domain in the USA.
Keus, Frederik; van der Horst, Iwan C C; Nijsten, Maarten W
Today's clinical research faces challenges such as a lack of clinical equipoise between treatment arms, reluctance in randomizing for multiple treatments simultaneously, inability to address interactions and increasingly restricted resources. Furthermore, many trials are biased by extensive exclusion criteria, relatively small sample size and less appropriate outcome measures. We propose a 'Multiplex' trial design that preserves clinical equipoise with a continuous and factorial trial design that will also result in more efficient use of resources. This multiplex design accommodates subtrials with appropriate choice of treatment arms within each subtrial. Clinical equipoise should increase consent rates while the factorial design is the best way to identify interactions. The multiplex design may evolve naturally from today's research limitations and challenges, while principal objections seem absent. However this new design poses important infrastructural, organisational and psychological challenges that need in depth consideration.
Background The Medical Research Councils’ framework for complex interventions has been criticized for not including theory-driven approaches to evaluation. Although the framework does include broad guidance on the use of theory, it contains little practical guidance for implementers and there have been calls to develop a more comprehensive approach. A prospective, theory-driven process of intervention design and evaluation is required to develop complex healthcare interventions which are more likely to be effective, sustainable and scalable. Methods We propose a theory-driven approach to the design and evaluation of complex interventions by adapting and integrating a programmatic design and evaluation tool, Theory of Change (ToC), into the MRC framework for complex interventions. We provide a guide to what ToC is, how to construct one, and how to integrate its use into research projects seeking to design, implement and evaluate complex interventions using the MRC framework. We test this approach by using ToC within two randomized controlled trials and one non-randomized evaluation of complex interventions. Results Our application of ToC in three research projects has shown that ToC can strengthen key stages of the MRC framework. It can aid the development of interventions by providing a framework for enhanced stakeholder engagement and by explicitly designing an intervention that is embedded in the local context. For the feasibility and piloting stage, ToC enables the systematic identification of knowledge gaps to generate research questions that strengthen intervention design. ToC may improve the evaluation of interventions by providing a comprehensive set of indicators to evaluate all stages of the causal pathway through which an intervention achieves impact, combining evaluations of intervention effectiveness with detailed process evaluations into one theoretical framework. Conclusions Incorporating a ToC approach into the MRC framework holds promise for
O’Cathain, A.; Hoddinott, P.; Lewin, S.; Thomas, K.J.; Young, B.; Adamson, J.; Jansen, J.F.M.; Mills, N.; Moore, G.; Donovan, J.L.
Feasibility studies are increasingly undertaken in preparation for randomised controlled trials in order to explore uncertainties and enable trialists to optimise the intervention or the conduct of the trial. Qualitative research can be used to examine and address key uncertainties prior to a full
Kearney, Anna; Daykin, Anne; Shaw, Alison R G; Lane, Athene J; Blazeby, Jane M; Clarke, Mike; Williamson, Paula; Gamble, Carrol
The failure to retain patients or collect primary-outcome data is a common challenge for trials and reduces the statistical power and potentially introduces bias into the analysis. Identifying strategies to minimise missing data was the second highest methodological research priority in a Delphi survey of the Directors of UK Clinical Trial Units (CTUs) and is important to minimise waste in research. Our aim was to assess the current retention practices within the UK and priorities for future research to evaluate the effectiveness of strategies to reduce attrition. Seventy-five chief investigators of NIHR Health Technology Assessment (HTA)-funded trials starting between 2009 and 2012 were surveyed to elicit their awareness about causes of missing data within their trial and recommended practices for improving retention. Forty-seven CTUs registered within the UKCRC network were surveyed separately to identify approaches and strategies being used to mitigate missing data across trials. Responses from the current practice surveys were used to inform a subsequent two-round Delphi survey with registered CTUs. A consensus list of retention research strategies was produced and ranked by priority. Fifty out of seventy-five (67%) chief investigators and 33/47 (70%) registered CTUs completed the current practice surveys. Seventy-eight percent of trialists were aware of retention challenges and implemented strategies at trial design. Patient-initiated withdrawal was the most common cause of missing data. Registered CTUs routinely used newsletters, timeline of participant visits, and telephone reminders to mitigate missing data. Whilst 36 out of 59 strategies presented had been formally or informally evaluated, some frequently used strategies, such as site initiation training, have had no research to inform practice. Thirty-five registered CTUs (74%) participated in the Delphi survey. Research into the effectiveness of site initiation training, frequency of patient contact
Cellarius, Richard A.; Platt, John
Discusses the role of national or international coordinating councils in focusing research on solutions of major human problems. Presents a taxonomy of 25 areas under the major heading: Physical Technology and Engineering; Biotechnology; Behavior and Personal Relations; National Social Structures; World Structure; and Channels of Effectiveness.…
DeVille, Priscilla; And Others
This paper summarizes the results of a research project completed by three doctoral students enrolled in an advanced curriculum development course at the University of Southern Mississippi (Hattiesburg). The students used a mock trial format to consider reasons to support establishment of a national curriculum (concerning the American public's…
Williamson Paula R
Full Text Available Abstract Background Randomised controlled trials (RCTs represent the gold standard methodological design to evaluate the effectiveness of an intervention in humans but they are subject to bias, including study publication bias and outcome reporting bias. National and international organisations and charities give recommendations for good research practice in relation to RCTs but to date no review of these guidelines has been undertaken with respect to reporting bias. Methods National and international organisations and UK based charities listed on the Association for Medical Research Charities website were contacted in 2007; they were considered eligible for this review if they funded RCTs. Guidelines were obtained and assessed in relation to what was written about trial registration, protocol adherence and trial publication. It was also noted whether any monitoring against these guidelines was undertaken. This information was necessary to discover how much guidance researchers are given on the publication of results, in order to prevent study publication bias and outcome reporting bias. Results Seventeen organisations and 56 charities were eligible of 140 surveyed for this review, although there was no response from 12. Trial registration, protocol adherence, trial publication and monitoring against the guidelines were often explicitly discussed or implicitly referred too. However, only eleven of these organisations or charities mentioned the publication of negative as well as positive outcomes and just three of the organisations specifically stated that the statistical analysis plan should be strictly adhered to and all changes should be reported. Conclusion Our review indicates that there is a need to provide more detailed guidance for those conducting and reporting clinical trials to help prevent the selective reporting of results. Statements found in the guidelines generally refer to publication bias rather than outcome reporting bias
Rubin, P.; Van Ess, J.D.
The authors present an outline review of the history of the formation of the cooperative group called International Clinical Trials in Radiation Oncology (ICTRO), and the following areas are briefly discussed together with some projections for the direction of clinical trials in radiation oncology into the 1990s:- radiosensitizers, radioprotectors, and their combination, drug-radiation interactions, dose/time/fractionation, hyperthermia, biological response modifiers and radiolabelled antibodies, high LET, particularly neutron therapy, large field irradiation and interoperative irradiation, research studies on specific sites. (U.K.)
Lim, Christopher T; Tadmor, Avia; Fujisawa, Daisuke; MacDonald, James J; Gallagher, Emily R; Eusebio, Justin; Jackson, Vicki A; Temel, Jennifer S; Greer, Joseph A; Hagan, Teresa; Park, Elyse R
While vast opportunities for using qualitative methods exist within palliative care research, few studies provide practical advice for researchers and clinicians as a roadmap to identify and utilize such opportunities. To provide palliative care clinicians and researchers descriptions of qualitative methodology applied to innovative research questions relative to palliative care research and define basic concepts in qualitative research. Body: We describe three qualitative projects as exemplars to describe major concepts in qualitative analysis of early palliative care: (1) a descriptive analysis of clinician documentation in the electronic health record, (2) a thematic content analysis of palliative care clinician focus groups, and (3) a framework analysis of audio-recorded encounters between patients and clinicians as part of a clinical trial. This study provides a foundation for undertaking qualitative research within palliative care and serves as a framework for use by other palliative care researchers interested in qualitative methodologies.
Fox, L. K.; Singer, J.
Undergraduate Research (UR) is broadly accepted as a high impact educational practice. Student participation in UR contributes to measurable gains in content knowledge and skills/methodology, oral and written communication skills, problem solving and critical thinking, self-confidence, autonomy, among others. First-generation college students and students from underrepresented minorities that participate in UR are more likely to remain in STEM majors, persist to graduation, and pursue graduate degrees. While engagement in the research process contributes to these outcomes, the impact of the interaction with the faculty mentor is critical. A number of studies provide evidence that it is the relationship that forms with the faculty mentor that is most valued by students and strongly contributes to their career development. Faculty mentors play an important role in student development and the relationship between mentor and student evolves from teacher to coach to colleague. Effective mentoring is not an inherent skill and is generally not taught in graduate school and generally differs from mentoring of graduate students. Each UR mentoring relationship is unique and there are many effective mentoring models and practices documented in the literature. The Council on Undergraduate Research (CUR) has a long history of supporting faculty who engage in research with undergraduates and offers resources for establishing UR programs at individual, departmental, and institutional levels. The Geosciences Division of CUR leads faculty development workshops at professional meetings and provides extensive resources to support geosciences faculty as UR mentors (http://serc.carleton.edu/NAGTWorkshops/undergraduate_research/index.html). Examples of effective mentoring strategies are highlighted, including a model developed by SUNY- Buffalo State that integrates mentoring directly into the evaluation of UR.
Van Der Baan, Frederieke H.; Knol, Mirjam J.|info:eu-repo/dai/nl/304820350; Klungel, Olaf H.|info:eu-repo/dai/nl/181447649; Egberts, Toine C.G.|info:eu-repo/dai/nl/162850050; Grobbee, Diederick E.; Roes, Kit C.B.
Background: An adaptive clinical trial design that allows population enrichment after interim analysis can be advantageous in pharmacogenetic research if previous evidence is not strong enough to exclude part of the patient population beforehand.With this design, underpowered studies or unnecessary
Tang, Chad; Hess, Kenneth R; Sanders, Dwana; Davis, Suzanne E; Buzdar, Aman U; Kurzrock, Razelle; Lee, J Jack; Meric-Bernstam, Funda; Hong, David S
Purpose: Information on processes for trials assessing investigational therapeutics is sparse. We assessed the trial development processes within the Department of Investigational Cancer Therapeutics (ICT) at MD Anderson Cancer Center (Houston, TX) and analyzed their effects on the trial activation timeline and enrolment. Experimental Design: Data were from a prospectively maintained registry that tracks all clinical studies at MD Anderson. From this database, we identified 2,261 activated phase I-III trials; 221 were done at the ICT. ICT trials were matched to trials from other MD Anderson departments by phase, sponsorship, and submission year. Trial performance metrics were compared with paired Wilcoxon signed rank tests. Results: We identified three facets of the ICT research infrastructure: parallel processing of trial approval steps; a physician-led research team; and regular weekly meetings to foster research accountability. Separate analyses were conducted stratified by sponsorship [industry (133 ICT and 133 non-ICT trials) or institutional (68 ICT and 68 non-ICT trials)]. ICT trial development was faster from IRB approval to activation (median difference of 1.1 months for industry-sponsored trials vs. 2.3 months for institutional) and from activation to first enrolment (median difference of 0.3 months for industry vs. 1.2 months for institutional; all matched P infrastructure within a large academic cancer center was associated with efficient trial development and participant accrual. Clin Cancer Res; 23(6); 1407-13. ©2016 AACR . ©2016 American Association for Cancer Research.
Speech to be delivered by Mr. François de Rose, president of Council of the european organization for nuclear research on the occasion of the inauguration of the CERN proton synchrotron on 5 february 1960
CERN Press Office. Geneva
Speech to be delivered by Mr. François de Rose, president of Council of the european organization for nuclear research on the occasion of the inauguration of the CERN proton synchrotron on 5 february 1960
30 March 2009 - Representatives of the Danish Council for Independent Research Natural Sciences visiting the LHC tunnel at Point 1 with Collaboration Spokesperson F. Gianotti, Former Spokesperson P. Jenni and Transition Radiation Tracker Project Leader C. Rembser.
30 March 2009 - Representatives of the Danish Council for Independent Research Natural Sciences visiting the LHC tunnel at Point 1 with Collaboration Spokesperson F. Gianotti, Former Spokesperson P. Jenni and Transition Radiation Tracker Project Leader C. Rembser.
Barisoni, Laura; Hodgin, Jeffrey B
In this review, we will discuss (i) how the recent advancements in digital technology and computational engineering are currently applied to nephropathology in the setting of clinical research, trials, and practice; (ii) the benefits of the new digital environment; (iii) how recognizing its challenges provides opportunities for transformation; and (iv) nephropathology in the upcoming era of kidney precision and predictive medicine. Recent studies highlighted how new standardized protocols facilitate the harmonization of digital pathology database infrastructure and morphologic, morphometric, and computer-aided quantitative analyses. Digital pathology enables robust protocols for clinical trials and research, with the potential to identify previously underused or unrecognized clinically useful parameters. The integration of digital pathology with molecular signatures is leading the way to establishing clinically relevant morpho-omic taxonomies of renal diseases. The introduction of digital pathology in clinical research and trials, and the progressive implementation of the modern software ecosystem, opens opportunities for the development of new predictive diagnostic paradigms and computer-aided algorithms, transforming the practice of renal disease into a modern computational science.
Toye, Francine; Williamson, Esther; Williams, Mark A; Fairbank, Jeremy; Lamb, Sarah E
Using an example of qualitative research embedded in a non-surgical feasibility trial, we explore the benefits of including qualitative research in trial design and reflect on epistemological challenges. We interviewed 18 trial participants and used methods of Interpretive Phenomenological Analysis. Our findings demonstrate that qualitative research can make a valuable contribution by allowing trial stakeholders to see things from alternative perspectives. Specifically, it can help to make specific recommendations for improved trial design, generate questions which contextualize findings, and also explore disease experience beyond the trial. To make the most out of qualitative research embedded in quantitative design it would be useful to (a) agree specific qualitative study aims that underpin research design, (b) understand the impact of differences in epistemological truth claims, (c) provide clear thematic interpretations for trial researchers to utilize, and (d) include qualitative findings that explore experience beyond the trial setting within the impact plan. © The Author(s) 2016.
Kyte, Derek; Ives, Jonathan; Draper, Heather; Keeley, Thomas; Calvert, Melanie
Patient-reported outcomes (PROs), such as health-related quality of life (HRQL) are increasingly used to evaluate treatment effectiveness in clinical trials, are valued by patients, and may inform important decisions in the clinical setting. It is of concern, therefore, that preliminary evidence, gained from group discussions at UK-wide Medical Research Council (MRC) quality of life training days, suggests there are inconsistent standards of HRQL data collection in trials and appropriate training and education is often lacking. Our objective was to investigate these reports, to determine if they represented isolated experiences, or were indicative of a potentially wider problem. We undertook a qualitative study, conducting 26 semi-structured interviews with research nurses, data managers, trial coordinators and research facilitators involved in the collection and entry of HRQL data in clinical trials, across one primary care NHS trust, two secondary care NHS trusts and two clinical trials units in the UK. We used conventional content analysis to analyze and interpret our data. Our study participants reported (1) inconsistent standards in HRQL measurement, both between, and within, trials, which appeared to risk the introduction of bias; (2), difficulties in dealing with HRQL data that raised concern for the well-being of the trial participant, which in some instances led to the delivery of non-protocol driven co-interventions, (3), a frequent lack of HRQL protocol content and appropriate training and education of trial staff, and (4) that HRQL data collection could be associated with emotional and/or ethical burden. Our findings suggest there are inconsistencies in the standards of HRQL data collection in some trials resulting from a general lack of HRQL-specific protocol content, training and education. These inconsistencies could lead to biased HRQL trial results. Future research should aim to develop HRQL guidelines and training programmes aimed at supporting
Addiction research centres and the nurturing of creativity: The Alcohol & Drug Abuse Research Unit at the South African Medical Research Council - strengthening substance abuse research and policy in South Africa.
Parry, Charles; Morojele, Neo; Myers, Bronwyn; Plüddemann, Andreas
The Alcohol and Drug Abuse Research Unit (ADARU) was established at the South African Medical Research Council (MRC) at the beginning of 2001, although its origins lie in the activities of the Centre for Epidemiological Research in Southern Africa and other MRC entities. Initial challenges included attracting external funding, recruiting new staff, developing the skills of junior staff, publishing in international journals and building national and international collaborative networks. ADARU currently comprises a core staff of 33 members who work on 22 projects spanning substance use epidemiology and associated consequences, intervention studies with at-risk populations and services research. A large component of this portfolio focuses on the link between alcohol and other drug use and human immunodeficiency virus (HIV) risk behaviour, with funding from the US Centers for Disease Control and Prevention. Junior staff members are encouraged to develop independent research interests and pursue PhD studies. Research outputs, such as the 20 papers that were published in 2010 and the 35 conference presentations from that year, form an important part of the unit's research translation activities. We engage actively with policy processes at the local, provincial, national and international levels, and have given particular attention to alcohol policy in recent years. The paper includes an analysis of major challenges currently facing the unit and how we are attempting to address them. It ends with some thoughts on what the unit intends doing to enhance the quality of its research, the capacity of its staff and its international standing. © 2011 The Authors, Addiction © 2011 Society for the Study of Addiction.
Full Text Available Margaret K Pasquale,1 Yihua Xu,1 Christine L Baker,2 Kelly H Zou,3 John G Teeter,4 Andrew M Renda,5 Cralen C Davis,1 Theodore C Lee,6 Joel Bobula2 1Comprehensive Health Insights, Inc., Humana Inc., Louisville, KY, 2Outcomes and Evidence, Global Health & Value, Pfizer Inc., 3Statistical Center for Outcomes, Real-World and Aggregate Data, Global Innovative Pharma Business, Pfizer Inc., New York, NY, 4Global Medical Development, Global Innovative Pharma Business, Pfizer Inc., Groton, CT, 5Retail Strategy & Execution, Humana Inc., Louisville, KY, 6Global Medical Affairs, Global Innovative Pharma Business, Pfizer Inc., New York, NY, USA Background: The Global initiative for chronic Obstructive Lung Disease guidelines recommend assessment of COPD severity, which includes symptomatology using the modified Medical Research Council (mMRC or COPD assessment test (CAT score in addition to the degree of airflow obstruction and exacerbation history. While there is great interest in incorporating symptomatology, little is known about how patient reported symptoms are associated with future exacerbations and exacerbation-related costs.Methods: The mMRC and CAT were mailed to a randomly selected sample of 4,000 Medicare members aged >40 years, diagnosed with COPD (≥2 encounters with International Classification of Diseases-9th Edition Clinical Modification: 491.xx, 492.xx, 496.xx, ≥30 days apart. The exacerbations and exacerbation-related costs were collected from claims data during 365-day post-survey after exclusion of members lost to follow-up or with cancer, organ transplant, or pregnancy. A logistic regression model estimated the predictive value of exacerbation history and symptomatology on exacerbations during follow-up, and a generalized linear model with log link and gamma distribution estimated the predictive value of exacerbation history and symptomatology on exacerbation-related costs.Results: Among a total of 1,159 members who returned the
Photo 01: Mr Peter Warry, PPARC Chairman, Victrex Plc, United Kingdom visiting the ATLAS SCT module tests with Dr Joleen Pater, SCT (Manchester). Photo 02: PPARC Council Members, United Kingdom, visiting the ATLAS SCT module tests. L.t to r.: Mrs Judith Scott, Chief Executive, British Computer Society, Prof. George Efstathiou, Institute of Astronomy, University of Cambridge, Mr Peter Warry, PPARC Chairman, Victrex Plc, Prof. Martin Ward, Director X-Ray Astronomy, of Leicester, Prof. James Stirling, Director, Institute for Particle Physics Phenomenology, University of Durham and Prof. Brian Foster, University of Bristol.
Salata, Camila; David, Mariano Gazineu; Almeida, Carlos Eduardo de
The absorbed dose to water standards for HDR brachytherapy dosimetry developed by the Radiology Science Laboratory, Brazil (LCR) and the National Research Council, Canada (NRC), were compared. The two institutions have developed absorbed dose standards based on the Fricke dosimetry system. There are significant differences between the two standards as far as the preparation and readout of the Fricke solution and irradiation geometry of the holder. Measurements were done at the NRC laboratory using a single Ir-192 source. The comparison of absorbed dose measurements was expressed as the ratio Dw(NRC)/Dw(LCR), which was found to be 1.026. (author)
Sami F Shaban
research culture’. This article examines the barriers to and benefits of physician participation in clinical research as well as interventions needed to increase their participation, including the specific role of undergraduate medical education. The main challenge is the unwillingness of many physicians and patients to participate in clinical trials. Barriers to participation include lack of time, lack of resources, trial-specific issues, communication difficulties, conflicts between the role of clinician and scientist, inadequate research experience and training for physicians, lack of rewards and recognition for physicians, and sometimes a scientifically uninteresting research question, among others. Strategies to encourage physician participation in clinical research include financial and nonfinancial incentives, adequate training, research questions that are in line with physician interests and have clear potential to improve patient care, and regular feedback. Finally, encouraging research culture and fostering the development of inquiry and research-based learning among medical students is now a high priority in order to develop more and better clinician-researchers.Keywords: physician, clinical research, clinical trial, medical education
Pagliaro, Mario; Meneguzzo, Francesco
Driven by insight for which new research and education requires new institutional organisation, and drawing on two decades of research and educational efforts, we devise the profile and activities of a new bioeconomy and solar energy institute at Italy's Research Council. We further articulate the institute's activities suggesting avenues on how to deploy sound and giving more useful research, education and policy advice in these crucial fields for making tomorrow's common development sustainable. The outcomes of the study are of general interest, because the transition to a solar economy is of intrinsic global nature and the challenges involved are similar in many countries. © 2017 Wiley-VCH Verlag GmbH & Co. KGaA, Weinheim.
Following the UK Medical Research Council\\'s (MRC) guidelines for the development and evaluation of complex interventions, this study aimed to design, develop and optimise an educational intervention about young men and unintended teenage pregnancy based around an interactive film. The process involved identification of the relevant evidence base, development of a theoretical understanding of the phenomenon of unintended teenage pregnancy in relation to young men, and exploratory mixed methods research. The result was an evidence-based, theory-informed, user-endorsed intervention designed to meet the much neglected pregnancy education needs of teenage men and intended to increase both boys\\' and girls\\' intentions to avoid an unplanned pregnancy during adolescence. In prioritising the development phase, this paper addresses a gap in the literature on the processes of research-informed intervention design. It illustrates the application of the MRC guidelines in practice while offering a critique and additional guidance to programme developers on the MRC prescribed processes of developing interventions. Key lessons learned were: (1) know and engage the target population and engage gatekeepers in addressing contextual complexities; (2) know the targeted behaviours and model a process of change; and (3) look beyond development to evaluation and implementation.
O'Cathain, A; Thomas, K J; Drabble, S J; Rudolph, A; Hewison, J
Objective To develop an empirically based framework of the aspects of randomised controlled trials addressed by qualitative research. Design Systematic mapping review of qualitative research undertaken with randomised controlled trials and published in peer-reviewed journals. Data sources MEDLINE, PreMEDLINE, EMBASE, the Cochrane Library, Health Technology Assessment, PsycINFO, CINAHL, British Nursing Index, Social Sciences Citation Index and ASSIA. Eligibility criteria Articles reporting qualitative research undertaken with trials published between 2008 and September 2010; health research, reported in English. Results 296 articles met the inclusion criteria. Articles focused on 22 aspects of the trial within five broad categories. Some articles focused on more than one aspect of the trial, totalling 356 examples. The qualitative research focused on the intervention being trialled (71%, 254/356); the design, process and conduct of the trial (15%, 54/356); the outcomes of the trial (1%, 5/356); the measures used in the trial (3%, 10/356); and the target condition for the trial (9%, 33/356). A minority of the qualitative research was undertaken at the pretrial stage (28%, 82/296). The value of the qualitative research to the trial itself was not always made explicit within the articles. The potential value included optimising the intervention and trial conduct, facilitating interpretation of the trial findings, helping trialists to be sensitive to the human beings involved in trials, and saving money by steering researchers towards interventions more likely to be effective in future trials. Conclusions A large amount of qualitative research undertaken with specific trials has been published, addressing a wide range of aspects of trials, with the potential to improve the endeavour of generating evidence of effectiveness of health interventions. Researchers can increase the impact of this work on trials by undertaking more of it at the pretrial stage and being explicit
Moore, Julia E; Grouchy, Michelle; Graham, Ian D; Shandling, Maureen; Doyle, Winnie; Straus, Sharon E
Despite evidence on what works in healthcare, there is a significant gap in the time it takes to bring research into practice. The Council of Academic Hospitals of Ontario's Adopting Research to Improve Care program addresses this research-to-practice gap by incorporating the following components into its funding program: strategic selection of evidence for implementation, education and training for implementation, implementation supports, executive champions and governance, and evaluation. Funded projects have been sustained (76% reported full sustainability) and spread to over 200 new sites. Lessons learned include the following: assess readiness, develop tailored implementation materials, consider characteristics of implementation supports, protect champion time and consider evaluation feasibility. Copyright © 2016 Longwoods Publishing.
By letter of 13 May 2003 the Council consulted Parliament, pursuant to Articles 31 and 32 of the EURATOM Treaty, on the proposal for a Council directive (EURATOM) on the management of spent nuclear fuel and radioactive waste (COM(2003) 32 - 2003/0022(CNS)). At the sitting of 15 May 2003 the President of Parliament announced that he had referred the proposal to the Committee on Industry, External Trade, Research and Energy as the committee responsible and the Committee on the Environment, Public Health and Consumer Policy for its opinion (C5-0229/2003). The Committee on Industry, External Trade, Research and Energy appointed Alejo Vidal-Quadras Roca Rapporteur at its meeting of 22 May 2003. The committee considered the Commission proposal and draft report at its meetings of 9 July, 9 September, 6 October, 3 November and 27 November 2003. At the last meeting it adopted the draft legislative resolution by 36 votes to 7, with 2 abstentions. The opinion of the Committee on the Environment, Public Health and Consumer Policy is attached. The report was tabled on 1 December 2003
Lutz, Kristina; Wilton, Kelly; Zytaruk, Nicole; Julien, Lisa; Hall, Richard; Harvey, Johanne; Skrobik, Yoanna; Vlahakis, Nicholas; Meade, Laurie; Matte, Andrea; Meade, Maureen; Burns, Karen; Albert, Martin; Cash, Bronwyn Barlow; Vallance, Shirley; Klinger, James; Heels-Ansdell, Diane; Cook, Deborah
Research ethics board (REB) review of scientific protocols is essential, ensuring participants' dignity, safety, and rights. The objectives of this study were to examine the time from submission to approval, to analyze predictors of approval time, and to describe the scope of conditions from REBs evaluating an international thromboprophylaxis trial. We generated survey items through literature review and investigators' discussions, creating 4 domains: respondent and institutional demographics, the REB application process, and alternate consent models. We conducted a document analysis that involved duplicate assessment of themes from REB critique of the protocol and informed consent forms (ICF). Approval was granted from 65 REB institutions, requiring 58 unique applications. We analyzed 44 (75.9%) of 58 documents and surveys. Survey respondents completing the applications had 8 (5-12) years of experience; 77% completed 4 or more REB applications in previous 5 years. Critical care personnel were represented on 54% of REBs. The time to approval was a median (interquartile range) of 75 (42, 150) days, taking longer for sites with national research consortium membership (89.1 vs 31.0 days, P = .03). Document analysis of the application process and ICF yielded 5 themes: methodology, data management, consent procedures, cataloguing, and miscellaneous. Protocol-specific themes focused on trial implementation, external critiques, and budget. The only theme specific to the ICF was risks and benefits. The most frequent comments on the protocol and ICF were about methodology and miscellaneous issues; ICF comments also addressed study risks and benefits. More studies on methods to enhance efficiency and consistency of the REB approval processes for clinical trials are needed while still maintaining high ethical standards. Copyright © 2012 Elsevier Inc. All rights reserved.
To complete the revamp of CERN’s Council Chamber, a new exhibition is being installed just in time for the June Council meetings. Panels will showcase highlights of CERN’s history, using some of the content prepared for the exhibitions marking 50 years of the PS, which were displayed in the main building last November. The previous photo exhibition in the Council Chamber stopped at the 1970s. To avoid the new panels becoming quickly out of date, photos are grouped together around specific infrastructures, rather than following a classic time-line. “We have put the focus on the accelerators – the world-class facilities that CERN has been offering researchers over the years, from the well-known large colliders to the lesser-known smaller facilities,” says Emma Sanders, who worked on the content. The new exhibition will be featured in a future issue of the Bulletin with photos and an interview with Fabienne Marcastel, designer of the exhibit...
Sawin, Veronica I; Robinson, Karen A
We assessed citation of prior research over time and the association of citation with the agreement of results between the trial being reported and the prior trial. Groups of pharmacologic trials in cardiovascular disease were created using meta-analyses, and we assessed citation within these groups. We calculated the proportion of prior trials cited, the proportion of study participants captured in citations, and agreement of results between citing and cited trials. Analysis included 86 meta-analyses with 580 trials published between 1982 and 2011. Reports of trials cited 25% (median; 95% confidence interval [CI], 23-27%) of prior trials, capturing 31% (95% CI, 25-36%) of trial participants. Neither measure differed by publication of the citing trial before vs. after 2005. Prior trials with results that agreed with the reports of trials (supportive trials) were significantly more likely to be cited than nonsupportive trials (relative risk 1.45; 95% CI, 1.30-1.61, P < 0.001). Selective undercitation of prior research continues; three quarters of existing evidence is ignored. This source of waste may result in unnecessary, unethical, and unscientific studies. Copyright © 2016 Elsevier Inc. All rights reserved.
Background Qualitative research is undertaken with randomized controlled trials of health interventions. Our aim was to explore the perceptions of researchers with experience of this endeavour to understand the added value of qualitative research to the trial in practice. Methods A telephone semi-structured interview study with 18 researchers with experience of undertaking the trial and/or the qualitative research. Results Interviewees described the added value of qualitative research for the trial, explaining how it solved problems at the pretrial stage, explained findings, and helped to increase the utility of the evidence generated by the trial. From the interviews, we identified three models of relationship of the qualitative research to the trial. In ‘the peripheral’ model, the trial was an opportunity to undertake qualitative research, with no intention that it would add value to the trial. In ‘the add-on’ model, the qualitative researcher understood the potential value of the qualitative research but it was viewed as a separate and complementary endeavour by the trial lead investigator and wider team. Interviewees described how this could limit the value of the qualitative research to the trial. Finally ‘the integral’ model played out in two ways. In ‘integral-in-theory’ studies, the lead investigator viewed the qualitative research as essential to the trial. However, in practice the qualitative research was under-resourced relative to the trial, potentially limiting its ability to add value to the trial. In ‘integral-in-practice’ studies, interviewees described how the qualitative research was planned from the beginning of the study, senior qualitative expertise was on the team from beginning to end, and staff and time were dedicated to the qualitative research. In these studies interviewees described the qualitative research adding value to the trial although this value was not necessarily visible beyond the original research team due
O'Cathain, Alicia; Goode, Jackie; Drabble, Sarah J; Thomas, Kate J; Rudolph, Anne; Hewison, Jenny
Qualitative research is undertaken with randomized controlled trials of health interventions. Our aim was to explore the perceptions of researchers with experience of this endeavour to understand the added value of qualitative research to the trial in practice. A telephone semi-structured interview study with 18 researchers with experience of undertaking the trial and/or the qualitative research. Interviewees described the added value of qualitative research for the trial, explaining how it solved problems at the pretrial stage, explained findings, and helped to increase the utility of the evidence generated by the trial. From the interviews, we identified three models of relationship of the qualitative research to the trial. In 'the peripheral' model, the trial was an opportunity to undertake qualitative research, with no intention that it would add value to the trial. In 'the add-on' model, the qualitative researcher understood the potential value of the qualitative research but it was viewed as a separate and complementary endeavour by the trial lead investigator and wider team. Interviewees described how this could limit the value of the qualitative research to the trial. Finally 'the integral' model played out in two ways. In 'integral-in-theory' studies, the lead investigator viewed the qualitative research as essential to the trial. However, in practice the qualitative research was under-resourced relative to the trial, potentially limiting its ability to add value to the trial. In 'integral-in-practice' studies, interviewees described how the qualitative research was planned from the beginning of the study, senior qualitative expertise was on the team from beginning to end, and staff and time were dedicated to the qualitative research. In these studies interviewees described the qualitative research adding value to the trial although this value was not necessarily visible beyond the original research team due to the challenges of publishing this research
Using the Medical Research Council framework for development and evaluation of complex interventions in a low resource setting to develop a theory-based treatment support intervention delivered via SMS text message to improve blood pressure control.
Bobrow, Kirsten; Farmer, Andrew; Cishe, Nomazizi; Nwagi, Ntobeko; Namane, Mosedi; Brennan, Thomas P; Springer, David; Tarassenko, Lionel; Levitt, Naomi
Several frameworks now exist to guide intervention development but there remains only limited evidence of their application to health interventions based around use of mobile phones or devices, particularly in a low-resource setting. We aimed to describe our experience of using the Medical Research Council (MRC) Framework on complex interventions to develop and evaluate an adherence support intervention for high blood pressure delivered by SMS text message. We further aimed to describe the developed intervention in line with reporting guidelines for a structured and systematic description. We used a non-sequential and flexible approach guided by the 2008 MRC Framework for the development and evaluation of complex interventions. We reviewed published literature and established a multi-disciplinary expert group to guide the development process. We selected health psychology theory and behaviour change techniques that have been shown to be important in adherence and persistence with chronic medications. Semi-structured interviews and focus groups with various stakeholders identified ways in which treatment adherence could be supported and also identified key features of well-regarded messages: polite tone, credible information, contextualised, and endorsed by identifiable member of primary care facility staff. Direct and indirect user testing enabled us to refine the intervention including refining use of language and testing of interactive components. Our experience shows that using a formal intervention development process is feasible in a low-resource multi-lingual setting. The process enabled us to pre-test assumptions about the intervention and the evaluation process, allowing the improvement of both. Describing how a multi-component intervention was developed including standardised descriptions of content aimed to support behaviour change will enable comparison with other similar interventions and support development of new interventions. Even in low
The field of personality and culture was given a significant impetus during the 1930s with the establishment of the Advisory Committee on Personality and Culture (1930-1934) by the Social Science Research Council. This committee provided an early formulation of personality and culture that emphasized the interdisciplinary focus on the processes of personality formation within small-scale social settings. The committee's formulation also coupled personality and culture with a liberal social engineering approach geared toward cultural reconstruction. Major social scientists and clinicians were involved in the activities of the committee, including Edward Sapir, W. I. Thomas, E. W. Burgess, E. A. Bott, Robert S. Woodworth, Harry Stack Sullivan, C. M. Hincks, and Adolf Meyer.
Oliveira, Maria Christina Lopes Araujo; Martelli, Daniella Reis; Quirino, Isabel Gomes; Colosimo, Enrico Antônio; Silva, Ana Cristina Simões e; Martelli Júnior, Hercílio; Oliveira, Eduardo Araujo de
several studies have examined the academic production of the researchers at the CNPq, in several areas of knowledge. The aim of this study was to evaluate the scientific production of researchers in Hematology/Oncology who hold scientific productivity grants from the Brazilian Council for Scientific and Technological Development. the Academic CVs of 28 researchers in Hematology/Oncology with active grants in the three-year period from 2006 to 2008 were included in the analysis. The variables of interest were: institution, researchers' time after doctorate, tutoring of undergraduate students, masters and PhD degree, scientific production and its impact. from a total of 411 researchers in Medicine, 28 (7%) were identified as being in the area of Hematology/Oncology. There was a slight predominance of males (53.6%) and grant holders in category 1. Three Brazilian states are responsible for approximately 90% of the researchers: São Paulo (21,75%), Rio de Janeiro (3,11%), and Minas Gerais (2, 7%). During their academic careers, the researchers published 2,655 articles, with a median of 87 articles per researcher (IQR = 52 to 122). 65 and 78% of this total were indexed on the Web of Science and Scopus databases, respectively. The researchers received 14,247 citations on the WoS database with a median of 385 citations per researcher. The average number of citations per article was 8.2. in this investigation, it was noted that researchers in the field of Hematology/Oncology have a relevant scientific output from the point of view of quantity and quality compared to other medical specialties.
de Laat, Sonya; Schwartz, Lisa
Introduction Prospective informed consent is required for most research involving human participants; however, this is impracticable under some circumstances. The Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS) outlines the requirements for research involving human participants in Canada. The need for an exception to consent (deferred consent) is recognised and endorsed in the TCPS for research in individual medical emergencies; however, little is known about substitute decision-maker (SDM) experiences. A paediatric resuscitation trial (SQUEEZE) (NCT01973907) using an exception to consent process began enrolling at McMaster Children's Hospital in January 2014. This qualitative research study aims to generate new knowledge on SDM experiences with the exception to consent process as implemented in a randomised controlled trial. Methods and analysis The SDMs of children enrolled into the SQUEEZE pilot trial will be the sampling frame from which ethics study participants will be derived. Design: Qualitative research study involving individual interviews and grounded theory methodology. Participants: SDMs for children enrolled into the SQUEEZE pilot trial. Sample size: Up to 25 SDMs. Qualitative methodology: SDMs will be invited to participate in the qualitative ethics study. Interviews with consenting SDMs will be conducted in person or by telephone, taped and professionally transcribed. Participants will be encouraged to elaborate on their experience of being asked to consent after the fact and how this process occurred. Analysis: Data gathering and analysis will be undertaken simultaneously. The investigators will collaborate in developing the coding scheme, and data will be coded using NVivo. Emerging themes will be identified. Ethics and dissemination This research represents a rare opportunity to interview parents/guardians of critically ill children enrolled into a resuscitation trial without their knowledge or prior consent
Parker, Melissa J; de Laat, Sonya; Schwartz, Lisa
Prospective informed consent is required for most research involving human participants; however, this is impracticable under some circumstances. The Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS) outlines the requirements for research involving human participants in Canada. The need for an exception to consent (deferred consent) is recognised and endorsed in the TCPS for research in individual medical emergencies; however, little is known about substitute decision-maker (SDM) experiences. A paediatric resuscitation trial (SQUEEZE) (NCT01973907) using an exception to consent process began enrolling at McMaster Children's Hospital in January 2014. This qualitative research study aims to generate new knowledge on SDM experiences with the exception to consent process as implemented in a randomised controlled trial. The SDMs of children enrolled into the SQUEEZE pilot trial will be the sampling frame from which ethics study participants will be derived. Qualitative research study involving individual interviews and grounded theory methodology. SDMs for children enrolled into the SQUEEZE pilot trial. Up to 25 SDMs. Qualitative methodology: SDMs will be invited to participate in the qualitative ethics study. Interviews with consenting SDMs will be conducted in person or by telephone, taped and professionally transcribed. Participants will be encouraged to elaborate on their experience of being asked to consent after the fact and how this process occurred. Data gathering and analysis will be undertaken simultaneously. The investigators will collaborate in developing the coding scheme, and data will be coded using NVivo. Emerging themes will be identified. This research represents a rare opportunity to interview parents/guardians of critically ill children enrolled into a resuscitation trial without their knowledge or prior consent. Findings will inform implementation of the exception to consent process in the planned definitive SQUEEZE
Good, Marjorie J; Hurley, Patricia; Woo, Kaitlin M; Szczepanek, Connie; Stewart, Teresa; Robert, Nicholas; Lyss, Alan; Gönen, Mithat; Lilenbaum, Rogerio
Clinical research program managers are regularly faced with the quandary of determining how much of a workload research staff members can manage while they balance clinical practice and still achieve clinical trial accrual goals, maintain data quality and protocol compliance, and stay within budget. A tool was developed to measure clinical trial-associated workload, to apply objective metrics toward documentation of work, and to provide clearer insight to better meet clinical research program challenges and aid in balancing staff workloads. A project was conducted to assess the feasibility and utility of using this tool in diverse research settings. Community-based research programs were recruited to collect and enter clinical trial-associated monthly workload data into a web-based tool for 6 consecutive months. Descriptive statistics were computed for self-reported program characteristics and workload data, including staff acuity scores and number of patient encounters. Fifty-one research programs that represented 30 states participated. Median staff acuity scores were highest for staff with patients enrolled in studies and receiving treatment, relative to staff with patients in follow-up status. Treatment trials typically resulted in higher median staff acuity, relative to cancer control, observational/registry, and prevention trials. Industry trials exhibited higher median staff acuity scores than trials sponsored by the National Institutes of Health/National Cancer Institute, academic institutions, or others. The results from this project demonstrate that trial-specific acuity measurement is a better measure of workload than simply counting the number of patients. The tool was shown to be feasible and useable in diverse community-based research settings. Copyright © 2016 by American Society of Clinical Oncology.
At the fall component meetings of the American Psychiatric Association in Arlington, Va., September 13-16, 2017, the APA councils heard reports from their components. Following are summaries of the activities of the councils and their components.
With this message I would like to share with you some highlights of this week’s Council meetings. A major topic was the approval of CERN’s Medium Term Plan (MTP) 2017-2021, along with the budget for 2017. In approving the document, Council expressed its very strong support for the research programme the MTP outlines for the coming years. Another important topic this week was the formal approval of the High Luminosity LHC project, HL-LHC. This comes as extremely good news not only for CERN, but also for particle physics globally. HL-LHC is the top priority of the European Strategy for Particle Physics in its 2013 update, and is part of the 2016 roadmap of the European Strategy Forum on Research Infrastructures, ESFRI. It was also identified as a priority in the US P5 strategy process, and in Japan’s strategic vision for the field. It secures CERN’s future until 2035, and ensures that we will achieve the maximum scientific return on the investment...
Brehaut Jamie C
Full Text Available Abstract This article is part of a series of papers examining ethical issues in cluster randomized trials (CRTs in health research. In the introductory paper in this series, we set out six areas of inquiry that must be addressed if the CRT is to be set on a firm ethical foundation. This paper addresses the first of the questions posed, namely, who is the research subject in a CRT in health research? The identification of human research subjects is logically prior to the application of protections as set out in research ethics and regulation. Aspects of CRT design, including the fact that in a single study the units of randomization, experimentation, and observation may differ, complicate the identification of human research subjects. But the proper identification of human research subjects is important if they are to be protected from harm and exploitation, and if research ethics committees are to review CRTs efficiently. We examine the research ethics literature and international regulations to identify the core features of human research subjects, and then unify these features under a single, comprehensive definition of human research subject. We define a human research subject as any person whose interests may be compromised as a result of interventions in a research study. Individuals are only human research subjects in CRTs if: (1 they are directly intervened upon by investigators; (2 they interact with investigators; (3 they are deliberately intervened upon via a manipulation of their environment that may compromise their interests; or (4 their identifiable private information is used to generate data. Individuals who are indirectly affected by CRT study interventions, including patients of healthcare providers participating in knowledge translation CRTs, are not human research subjects unless at least one of these conditions is met.
Networking Africa's science granting councils ... to support research and evidence-based policies that contribute to social and economic development. ... exchanges and forums, online training, on-site coaching, and collaborative research.
... 7 Agriculture 10 2010-01-01 2010-01-01 false Council. 1230.6 Section 1230.6 Agriculture Regulations of the Department of Agriculture (Continued) AGRICULTURAL MARKETING SERVICE (MARKETING AGREEMENTS... CONSUMER INFORMATION Pork Promotion, Research, and Consumer Information Order Definitions § 1230.6 Council...
The Utah Department of Transportation (UDOT) held a Research Peer Exchange on October 12-13, 2016, in downtown Salt Lake City. The focus topics or themes for the peer exchange included the following: : Supporting Implementation During and A...
Aventin, Áine; Lohan, Maria; O'Halloran, Peter; Henderson, Marion
Following the UK Medical Research Council's (MRC) guidelines for the development and evaluation of complex interventions, this study aimed to design, develop and optimise an educational intervention about young men and unintended teenage pregnancy based around an interactive film. The process involved identification of the relevant evidence base, development of a theoretical understanding of the phenomenon of unintended teenage pregnancy in relation to young men, and exploratory mixed methods research. The result was an evidence-based, theory-informed, user-endorsed intervention designed to meet the much neglected pregnancy education needs of teenage men and intended to increase both boys' and girls' intentions to avoid an unplanned pregnancy during adolescence. In prioritising the development phase, this paper addresses a gap in the literature on the processes of research-informed intervention design. It illustrates the application of the MRC guidelines in practice while offering a critique and additional guidance to programme developers on the MRC prescribed processes of developing interventions. Key lessons learned were: (1) know and engage the target population and engage gatekeepers in addressing contextual complexities; (2) know the targeted behaviours and model a process of change; and (3) look beyond development to evaluation and implementation. Copyright © 2014 The Authors. Published by Elsevier Ltd.. All rights reserved.
Alison M. Meadow
Full Text Available The National Research Council (NRC proposed six principles for effective decision support in its 2009 report Informing Decisions in a Changing Climate. We structured a collaborative project between the Federal Emergency Management Agency Region R9 (FEMA R9, the Western Region Headquarters of the National Weather Service (WR-NWS, and the Climate Assessment of the Southwest (CLIMAS at the University of Arizona around the application of the NRC principles. The goal of the project was to provide FEMA R9's Watch Office with climate information scaled to their temporal and spatial interests to aid them in assessing the potential risk of flood disasters. We found that we needed specific strategies and activities in order to apply the principles effectively. By using a set of established collaborative research approaches we were better able to assess FEMA R9's information needs and WR-NWS's capacity to meet those needs. Despite our diligent planning of engagement strategies, we still encountered some barriers to transitioning our decision support tool from research to operations. This paper describes our methods for planning and executing a three-party collaborative effort to provide climate services, the decision support tool developed through this process, and the lessons we will take from this deliberate collaborative process to our future work and implications of the NRC principles for the broader field of climate services. Keywords: Climate services, Emergency management, Flood risk, Decision support
Brain Tumor Trials Collaborative In Pursuit of a Cure The mission of the BTTC is to develop and perform state-of-the-art clinical trials in a collaborative and collegial environment, advancing treatments for patients with brain tumors, merging good scientific method with concern for patient well-being and outcome.
Ali, Shabana Amanda; Kloseck, Marita; Lee, Karen; Walsh, Kathleen Ellen; MacDermid, Joy C; Fitzsimmons, Deborah
Among the challenges in health research is translating interventions from controlled experimental settings to clinical and community settings where chronic disease is managed daily. Pragmatic trials offer a method for testing interventions in real-world settings but are seldom used in OA research. The aim of this study was to evaluate the literature on pragmatic trials in OA research up to August 2016 in order to identify strengths and weaknesses in the design and reporting of these trials. We used established guidelines to assess the degree to which 61 OA studies complied with pragmatic trial design and reporting. We assessed design according to the pragmatic-explanatory continuum indicator summary and reporting according to the pragmatic trials extension of the CONsolidated Standards of Reporting Trials guidelines. None of the pragmatic trials met all 11 criteria evaluated and most of the trials met between 5 and 8 of the criteria. Criteria most often unmet pertained to practitioner expertise (by requiring specialists) and criteria most often met pertained to primary outcome analysis (by using intention-to-treat analysis). Our results suggest a lack of highly pragmatic trials in OA research. We identify this as a point of opportunity to improve research translation, since optimizing the design and reporting of pragmatic trials can facilitate implementation of evidence-based interventions for OA care. © The Author 2017. Published by Oxford University Press on behalf of the British Society for Rheumatology. All rights reserved. For Permissions, please email: email@example.com
The foundation of C. N. R. in 1923 created in Italy a new public system of research, different from the university one. During fascism, the contribution of C. N. R. to the development of medical research in Italy was very poor. This was mainly due to insufficient means: structures and money. Moreover, the scientists who carried on medical research within the C. N. R. were the same who already held strong university positions, which mean a complete dependence on the academic system. The ideology of fascism also contribute to the weakness of the Italian medical research promoted by the C. N. R.. According to fascist view, science, and for its nature and aims above all medicine, had to addressed to technical, practical, or much better, social achievements. Consequently, the policy of medical research at the C.N.R. was to improve social or political medicine, mainly hygiene. This was in harmony with the demographic policy, which means the policy of reinforcement of "Italian race", and positive eugenics that fascism tried to pursue.
Weber, Alan S; Turjoman, Rebal; Shaheen, Yanal; Al Sayyed, Farah; Hwang, Mu Ji; Malick, Faryal
Introduction The Gulf Cooperation Council (GCC or 'Arabian Gulf'), comprising Bahrain, Kuwait, Oman, Qatar, Saudi Arabia and United Arab Emirates, is a political organization sharing a common history and culture. All GCC nations have made substantial investments in telecommunications and electronic health infrastructure since 2000. Methods We conducted a literature search in English and Arabic on peer-reviewed e-health research up to December 2014 originating in the GCC. The objective was to retrieve all research on e-health in the GCC and to categorize and analyse it qualitatively to reveal the current state of e-health research and development in the region. Inclusion criteria included peer-reviewed articles, books, book chapters, conference papers and graduate theses written on e-health in the GCC. Blogs, health websites and non-peer-reviewed literature were excluded. Results Three hundred and six articles were retrieved, categorized and analysed qualitatively to reveal the state of e-health research in the GCC. Both country-specific and GCC-wide major themes were identified using NVivo 10.0 qualitative software and summarized. The most common type of study was an overview (35.0%), with common study designs of case studies (26.8%) and descriptive articles (46.4%). Significant themes were: prospective national benefits from e-health, implementation and satisfaction with electronic health records, online technologies in medical education, innovative systems (case studies), and information security and personal health information. Discussion This is the first comprehensive analytical literature review of e-health in the GCC. Important research gaps were identified: few cost-benefit analyses, controlled interventional studies, or research targeting gender and religious issues were retrieved.
Kao, Chi-Yin; Huang, Guey-Shiun; Dai, Yu-Tzu; Pai, Ya-Ying; Hu, Wen-Yu
Clinical research nurses (CRNs) play an important role in improving the quality of clinical trials. In Taiwan, the increasing number of clinical trials has increased the number of practicing CRNs. Understanding the role responsibilities of CRNs is necessary to promote professionalism in this nursing category. This study investigates the role responsibilities of CRNs in conducting clinical trials / research. A questionnaire survey was conducted in a medical center in Taipei City, Taiwan. Eighty CRNs that were registered to facilitate and conduct clinical trials at this research site completed the survey. "Subject protection" was the CRN role responsibility most recognized by participants, followed by "research coordination and management", "subject clinical care", and "advanced professional nursing". Higher recognition scores were associated with higher importance scores and lower difficulty scores. Participants with trial training had significantly higher difficulty scores for "subject clinical care" and "research coordination and management" than their peers without this training (p research coordination and management" (p clinical practice.
Harris, M; Macinko, J; Jimenez, G; Mahfoud, M; Anderson, C
The source of research may influence one's interpretation of it in either negative or positive ways, however, there are no robust experiments to determine how source impacts on one's judgment of the research article. We determine the impact of source on respondents' assessment of the quality and relevance of selected research abstracts. Web-based survey design using four healthcare research abstracts previously published and included in Cochrane Reviews. All Council on the Education of Public Health-accredited Schools and Programmes of Public Health in the USA. 899 core faculty members (full, associate and assistant professors) Each of the four abstracts appeared with a high-income source half of the time, and low-income source half of the time. Participants each reviewed the same four abstracts, but were randomly allocated to receive two abstracts with high-income source, and two abstracts with low-income source, allowing for within-abstract comparison of quality and relevance Within-abstract comparison of participants' rating scores on two measures--strength of the evidence, and likelihood of referral to a peer (1-10 rating scale). OR was calculated using a generalised ordered logit model adjusting for sociodemographic covariates. Participants who received high income country source abstracts were equal in all known characteristics to the participants who received the abstracts with low income country sources. For one of the four abstracts (a randomised, controlled trial of a pharmaceutical intervention), likelihood of referral to a peer was greater if the source was a high income country (OR 1.28, 1.02 to 1.62, pincome source in their rating of research abstracts. More research may be needed to explore how the origin of a research article may lead to stereotype activation and application in research evaluation. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/
Folio Assessment or External Examinations? An Investigation into Alternative Means of Assessing SCE Ordinary Grade English. Report to the Scottish Certificate of Education Examination Board from the Scottish Council for Research in Education.
From 1974 through 1978, three methods of assessing Scottish high school students' (O level) English achievement were studied: (1) Ordinary (O level) examinations; (2) assessment of writing skills (folio assessment); and (3) criterion referenced tests developed by the Scottish Council for Research in Education (SCRE) to measure the objectives of…
Investigating sensitivity, specificity, and area under the curve of the Clinical COPD Questionnaire, COPD Assessment Test, and Modified Medical Research Council scale according to GOLD using St George's Respiratory Questionnaire cutoff 25 (and 20) as reference
Tsiligianni, Ioanna G.; Alma, Harma J.; de Jong, Corina; Jelusic, Danijel; Wittmann, Michael; Schuler, Michael; Schultz, Konrad; Kollen, Boudewijn J.; van der Molen, Thys; Kocks, Janwillem W. H.
Background: In the GOLD (Global initiative for chronic Obstructive Lung Disease) strategy document, the Clinical COPD Questionnaire (CCQ), COPD Assessment Test (CAT), or modified Medical Research Council (mMRC) scale are recommended for the assessment of symptoms using the cutoff points of CCQ >= 1,
van der Most, F.V.
This thesis investigates how research funding organizations (RFOs) respond to a new emerging field of science and technology. It takes nanoscience and nanotechnology (nanotechnology for short) as its case and compares the responses of RFOs in Finland, the Netherlands, Norway and Finland.
Tandon, Neeraj; Yadav, Satyapal Singh
Medicinal plants belong to the oldest known health care products that have been used by human beings all over the world and are major components of the formulations used in indigenous system of medicine practiced in many countries. Besides, finding place as health supplements, nutraceuticals, cosmetics, herbal tea etc. there has been a global insurgence of interest, including India, leading to enormous research/activities in the area of medicinal plants. The article is aimed to provide the effort and initiatives of ICMR towards research on medicinal plants and its contributions on consolidation of Indian research on medicinal plants that are very relevant and important in the national context. The various initiatives undertaken by ICMR on research on traditional medicines/medicinal plants in the past are reviewed and documented in this article. The multi-disciplinary, multicentric research initiatives of ICMR have resulted in validation of traditional treatment Kshaarasootra (medicated Ayurvedic thread) for anal fistula, Vijayasar (heart wood of Pterocarpus marsupium Roxb.) for diabetes mellitus, encouraging micro- and macrofilaricidal activity of Shakotak (stem bark of Streblus asper Lour.) in experimental studies an iridoid glycosides fraction isolated from root/rhizomes of Picrorhiza kurroa Royle ex Benth. (designated as Picroliv) for viral hepatitis. Other developmental and compilation of research works on Indian medicinal plants have resulted in publications of the thirteen volumes of quality standards, comprising of 449 Indian medicinal plants; three volumes of 90 phytochemical reference standards; fifteen volumes of review monographs on 4167 medicinal plant species; and one publication each on perspectives of Indian medicinal plants for management of liver disorders, lymphatic filariasis and diabetes mellitus (details available at http://www.icmr.nic.in/mpsite). The ICMR efforts assume special significance in the light of multifaceted use of medicinal plants
The article analyses the importance of laboratory test methods, namely pathomorfological at conduct of clinical trials. The article focuses on complex laboratory diagnostics at determination of clinical condition of animals, safety and efficacy of tested medicinal product.
de Melo-Martín, Inmaculada; Sondhi, Dolan; Crystal, Ronald G
For more than three decades clinical research in the United States has been explicitly guided by the idea that ethical considerations must be central to research design and practice. In spite of the centrality of this idea, attempting to balance the sometimes conflicting values of advancing scientific knowledge and protecting human subjects continues to pose challenges. Possible conflicts between the standards of scientific research and those of ethics are particularly salient in relation to trial design. Specifically, the choice of a control arm is an aspect of trial design in which ethical and scientific issues are deeply entwined. Although ethical quandaries related to the choice of control arms may arise when conducting any type of clinical trials, they are conspicuous in early phase gene transfer trials that involve highly novel approaches and surgical procedures and have children as the research subjects. Because of children's and their parents' vulnerabilities, in trials that investigate therapies for fatal, rare diseases affecting minors, the scientific and ethical concerns related to choosing appropriate controls are particularly significant. In this paper we use direct gene transfer to the central nervous system to treat late infantile neuronal ceroid lipofuscinosis to illustrate some of these ethical issues and explore possible solutions to real and apparent conflicts between scientific and ethical considerations.
Full Text Available ... Clinical Trials About Clinical Trials Clinical trials are research studies that explore whether a medical strategy, treatment, or ... humans. What Are Clinical Trials? Clinical trials are research studies that explore whether a medical strategy, treatment, or ...
Corvo, Arthur Francis
Given the reality that active and competitive participation in the 21 st century requires American students to deepen their scientific and mathematical knowledge base, the National Research Council (NRC) proposed a new conceptual framework for K--12 science education. The framework consists of an integration of what the NRC report refers to as the three dimensions: scientific and engineering practices, crosscutting concepts, and core ideas in four disciplinary areas (physical, life and earth/spaces sciences, and engineering/technology). The Next Generation Science Standards (NGSS ), which are derived from this new framework, were released in April 2013 and have implications on teacher learning and development in Science, Technology, Engineering, and Mathematics (STEM). Given the NGSS's recent introduction, there is little research on how teachers can prepare for its release. To meet this research need, I implemented a self-study aimed at examining my teaching practices and classroom outcomes through the lens of the NRC's conceptual framework and the NGSS. The self-study employed design-based research (DBR) methods to investigate what happened in my secondary classroom when I designed, enacted, and reflected on units of study for my science, engineering, and mathematics classes. I utilized various best practices including Learning for Use (LfU) and Understanding by Design (UbD) models for instructional design, talk moves as a tool for promoting discourse, and modeling instruction for these designed units of study. The DBR strategy was chosen to promote reflective cycles, which are consistent with and in support of the self-study framework. A multiple case, mixed-methods approach was used for data collection and analysis. The findings in the study are reported by study phase in terms of unit planning, unit enactment, and unit reflection. The findings have implications for science teaching, teacher professional development, and teacher education.
Carolina Gomes Freitas
Full Text Available CONTEXT AND OBJECTIVE: Clinical trial registration is a prerequisite for publication in respected scientific journals. Recent Brazilian regulations also require registration of some clinical trials in the Brazilian Clinical Trials Registry (ReBEC but there is little information available about practical issues involved in the registration process. This article discusses the importance of clinical trial registration and the practical issues involved in this process. DESIGN AND SETTING: Descriptive study conducted by researchers within a postgraduate program at a public university in São Paulo, Brazil. METHODS: Information was obtained from clinical trial registry platforms, article reference lists and websites (last search: September 2014 on the following topics: definition of a clinical trial, history, purpose and importance of registry platforms, the information that should be registered and the registration process. RESULTS: Clinical trial registration aims to avoid publication bias and is required by Brazilian journals indexed in LILACS and SciELO and by journals affiliated to the International Committee of Medical Journal Editors (ICMJE. Recent Brazilian regulations require that all clinical trials (phases I to IV involving new drugs to be marketed in this country must be registered in ReBEC. The pros and cons of using different clinical trial registration platforms are discussed. CONCLUSIONS: Clinical trial registration is important and various mechanisms to enforce its implementation now exist. Researchers should take into account national regulations and publication requirements when choosing the platform on which they will register their trial.
Drabble, Sarah J; O'Cathain, Alicia; Thomas, Kate J; Rudolph, Anne; Hewison, Jenny
There is growing recognition of the value of conducting qualitative research with trials in health research. It is timely to reflect on how this qualitative research is presented in grant proposals to identify lessons for researchers and research commissioners. As part of a larger study focusing on how to maximise the value of undertaking qualitative research with trials, we undertook a documentary analysis of proposals of funded studies. Using the metaRegister of Controlled Trials (mRCT) database we identified trials funded in the United Kingdom, ongoing between 2001 and 2010, and reporting the use of qualitative research. We requested copies of proposals from lead researchers. We extracted data from the proposals using closed and open questions, analysed using descriptive statistics and content analysis respectively. 2% (89/3812) of trials in the mRCT database described the use of qualitative research undertaken with the trial. From these 89 trials, we received copies of 36 full proposals, of which 32 met our inclusion criteria. 25% used less than a single paragraph to describe the qualitative research. The aims of the qualitative research described in these proposals focused mainly on the intervention or trial conduct. Just over half (56%) of the proposals included an explicit rationale for conducting the qualitative research with the trial, the most frequent being to optimise implementation into clinical practice or to interpret trial findings. Key information about methods, expertise and resources was missing in a large minority of proposals, in particular sample size, type of analysis, and non-personnel resources. 28% specifically stated that qualitative researchers would conduct the qualitative research. Our review of proposals of successfully funded studies identified good practice but also identified limited space given to describing the qualitative research, with an associated lack of attention to the rationale for doing the qualitative research and
Background There is growing recognition of the value of conducting qualitative research with trials in health research. It is timely to reflect on how this qualitative research is presented in grant proposals to identify lessons for researchers and research commissioners. As part of a larger study focusing on how to maximise the value of undertaking qualitative research with trials, we undertook a documentary analysis of proposals of funded studies. Methods Using the metaRegister of Controlled Trials (mRCT) database we identified trials funded in the United Kingdom, ongoing between 2001 and 2010, and reporting the use of qualitative research. We requested copies of proposals from lead researchers. We extracted data from the proposals using closed and open questions, analysed using descriptive statistics and content analysis respectively. Results 2% (89/3812) of trials in the mRCT database described the use of qualitative research undertaken with the trial. From these 89 trials, we received copies of 36 full proposals, of which 32 met our inclusion criteria. 25% used less than a single paragraph to describe the qualitative research. The aims of the qualitative research described in these proposals focused mainly on the intervention or trial conduct. Just over half (56%) of the proposals included an explicit rationale for conducting the qualitative research with the trial, the most frequent being to optimise implementation into clinical practice or to interpret trial findings. Key information about methods, expertise and resources was missing in a large minority of proposals, in particular sample size, type of analysis, and non-personnel resources. 28% specifically stated that qualitative researchers would conduct the qualitative research. Conclusions Our review of proposals of successfully funded studies identified good practice but also identified limited space given to describing the qualitative research, with an associated lack of attention to the rationale for
Magazi, Busisiwe; Stadler, Jonathan; Delany-Moretlwe, Sinead; Montgomery, Elizabeth; Mathebula, Florence; Hartmann, Miriam; van der Straten, Ariane
Although significant progress has been made in clinical trials of women-controlled methods of HIV prevention such as microbicides and Pre-exposure Prophylaxis (PrEP), low adherence to experimental study products remains a major obstacle to being able to establish their efficacy in preventing HIV infection. One factor that influences adherence is the ability of trial participants to attend regular clinic visits at which trial products are dispensed, adherence counseling is administered, and participant safety is monitored. We conducted a qualitative study of the social contextual factors that influenced adherence in the VOICE (MTN-003) trial in Johannesburg, South Africa, focusing on study participation in general, and study visits in particular. The research used qualitative methodologies, including in-depth interviews (IDI), serial ethnographic interviews (EI), and focus group discussions (FGD) among a random sub-sample of 102 female trial participants, 18 to 40 years of age. A socio-ecological framework that explored those factors that shaped trial participation and adherence to study products, guided the analysis. Key codes were developed to standardize subsequent coding and a node search was used to identify texts relating to obstacles to visit adherence. Our analysis includes coded transcripts from seven FGD (N = 40), 41 IDI, and 64 serial EI (N = 21 women). Women's kinship, social, and economic roles shaped their ability to participate in the clinical trial. Although participants expressed strong commitments to attend study visits, clinic visit schedules and lengthy waiting times interfered with their multiple obligations as care givers, wage earners, housekeepers, and students. The research findings highlight the importance of the social context in shaping participation in HIV prevention trials, beyond focusing solely on individual characteristics. This points to the need to focus interventions to improve visit attendance by promoting a culture of
Salins, Naveen; Gursahani, Roop; Mathur, Roli; Iyer, Shivakumar; Macaden, Stanley; Simha, Nagesh; Mani, Raj Kumar; Rajagopal, M. R.
Background: Indian hospitals, in general, lack policies on the limitation of inappropriate life-sustaining interventions at the end of life. To facilitate discussion, preparation of guidelines and framing of laws, terminologies relating to the treatment limitation, and providing palliative care at the end-of-life care (EOLC) need to be defined and brought up to date. Methodology: This consensus document on terminologies and definitions of terminologies was prepared under the aegis of the Indian Council of Medical Research. The consensus statement was created using Nominal Group and Delphi Method. Results: Twenty-five definitions related to the limitations of treatment and providing palliative care at the end of life were created by reviewing existing international documents and suitably modifying it to the Indian sociocultural context by achieving national consensus. Twenty-five terminologies defined within the scope of this document are (1) terminal illness, (2) actively dying, (3) life-sustaining treatment, (4) potentially inappropriate treatment, (5) cardiopulmonary resuscitation (CPR), (6) do not attempt CPR, (7) withholding life-sustaining treatment, (8) withdrawing life-sustaining treatment, (9) euthanasia (10) active shortening of the dying process, (11) physician-assisted suicide, (12) palliative care, (13) EOLC, (14) palliative sedation, (15) double effect, (16) death, (17) best interests, (18) health-care decision-making capacity, (19) shared decision-making, (20) advance directives, (21) surrogates, (22) autonomy, (23) beneficence, (24) nonmaleficence, and (25) justice.
Thomas, Kim S; Koller, Karin; Foster, Katharine; Perdue, Jo; Charlesworth, Lisa; Chalmers, Joanne R
Following the successful introduction of five topic-specific research networks in the UK, the Comprehensive Local Research Network (CLRN) was established in 2008 in order to provide a blanket level of support across the whole country regardless of the clinical discipline. The role of the CLRN was to facilitate recruitment into clinical trials, and to encourage greater engagement in research throughout the National Health Service (NHS). This report evaluates the impact of clinical research networks in supporting clinical trials in the UK, with particular reference to our experiences from two non-commercial dermatology trials. It covers our experience of engaging with the CLRN (and other research networks) using two non-commercial dermatology trials as case studies. We present the circumstances that led to our approach to the research networks for support, and the impact that this support had on the delivery of these trials. In both cases, recruitment was boosted considerably following the provision of additional support, although other factors such as the availability of experienced personnel, and the role of advertising and media coverage in promoting the trials were also important in translating this additional resource into increased recruitment. Recruitment into clinical trials is a complex task that can be influenced by many factors. A world-class clinical research infrastructure is now in place in England (with similar support available in Scotland and Wales), and it is the responsibility of the research community to ensure that this unique resource is used effectively and responsibly.
This exhaustive study, in assessing the roles of nuclear and alternative energy systems in the nation's energy future, focuses on the period between 1985 and 2010. Its intent is to illuminate the kinds of options the nation may wish to keep open in the future and to describe the actions, policies, and R and D programs that may be required to do so. The timing and the context of these decisions depend not only on the technical, social, and economic features of energy-supply technologies, but also on assumptions about future demand for energy and the possibilities for energy conservation through changes in consumption patterns and improved efficiency of the supply and end-use systems. The committee developed a three-tiered functional structure for the project. The first tier was CONAES itself, whose report embodies the ultimate findings, conclusions, and judgments of the study. To provide scientific and engineering data and economic analyses for the committee, a second tier of four panels was appointed by the committee to examine (1) energy demand and conservation, (2) energy supply and delivery systems, (3) risks and impacts of energy supply and use, and (4) various models of possible future energy systems and decision making. Each panel in turn established a number of resource groups - some two dozen in all - to address in detail an array of more particular matters. Briefly stated, recommended strategies are: (1) increased energy conservation; (2) expansion of the nation's balanced coal and nuclear electrical generation base; (3) retention of the breeder option; (4) stimulation of fluid energy development; and (5) immediate increase in research and development of new energy options to ensure availability over the long term.
Tyndall, Alan; Ladner, Ulf M; Matucci-Cerinic, Marco
Systemic sclerosis has a complex pathogenesis and a multifaceted clinical spectrum without a specific treatment. Under the auspices of the European League Against Rheumatism, the European League Against Rheumatism Scleroderma Trials And Research group (EUSTAR) has been founded in Europe to foster the study of systemic sclerosis with the aim of achieving equality of assessment and care of systemic sclerosis patients throughout the world according to evidence-based principles. EUSTAR created the minimal essential data set, a simple two-page form with basic demographics and mostly yes/no answers to clinical and laboratory parameters, to track patients throughout Europe. Currently, over 7000 patients are registered from 150 centres in four continents, and several articles have been published with the data generated by the minimal essential data set. A commitment of EUSTAR is also to teaching and educating, and for this reason there are two teaching courses and a third is planned for early in 2009. These courses have built international networks among young investigators improving the quality of multicentre clinical trials. EUSTAR has organized several rounds of 'teach the teachers' to further standardize the skin scoring. EUSTAR activities have extended beyond European borders, and EUSTAR now includes experts from several nations. The growth of data and biomaterial might ensure many further fruitful multicentre studies, but the financial sustainability of EUSTAR remains an issue that may jeopardize the existence of this group as well as that of other organizations in the world.
Dec 20, 2017 ... ... who are less able to make the right choices to protect themselves — has ... A related project, also supported by IDRC, provided training to boost ... The trial interventions had the most impact among young women in Botswana. ... of the young women in communities who received the intervention package.
A relatively small number of African sites have the clinical and laboratory capacity to design, manage and carry out HIV/AIDS prevention trials. This project is based on the premise that many of the required skills are already present at additional locations, but need further development. The grant will facilitate interaction ...
Hatcher, Simon; Sharon, Cynthia; Coggan, Carol
There is a lack of evidence about what is the best treatment for people who present to hospital after self harm. Most treatment trials have been small and involved unrepresentative groups of patients which result in inconclusive findings. Here we note some of the characteristics of attempted suicide which make it a difficult subject to study. We…
I would like to inform you of the main news from the Council this week. First of all, the Council congratulated CERN and the Collaborations on the superb performance of the accelerator complex and experiments. It has been a great year so far, with important physics results across the whole spectrum of the CERN research programme. Looking forward, one of the main accomplishments from this week’s meetings is that the Council has approved the opening of a credit facility with the European Investment Bank (EIB) to cover the cash shortage during the peak years of the High-Luminosity LHC (HL-LHC) construction. This is very good news since it will allow us to carry out the work necessary for the HL-LHC without compromising the rest of the Laboratory’s scientific programme. Turning to the scientific and geographical enlargement, the Council approved the admission of India as an Associate Member State, and I very much hope that the agreement can be signed in the near future so that Indi...
Records of the 10. ITER Council Meeting (IC-10), held on 26-27 July 1996, in St. Petersburg, Russia, and the 11. ITER Council Meeting (IC-11) held on 17-18 December 1996, in Tokyo, Japan, are presented, giving essential information on the evolution of the ITER Engineering Design Activities (EDA) and the cost review and safety analysis. Figs, tabs
Knudsen, Herman Lyhne
The theme addressed by this artcle is the opportunities for European Works Councils of gaining influence on corporate decisions in multinational companies.......The theme addressed by this artcle is the opportunities for European Works Councils of gaining influence on corporate decisions in multinational companies....
Fuentes Camps, Inmaculada; Rodríguez, Alexis; Agustí, Antonia
There are many difficulties in undertaking independent clinical research without support from the pharmaceutical industry. In this retrospective observational study, some design characteristics, the clinical trial public register and the publication rate of noncommercial clinical trials were compared to those of commercial clinical trials. A total of 809 applications of drug-evaluation clinical trials were submitted from May 2004 to May 2009 to the research ethics committee of a tertiary hospital, and 16.3% of trials were noncommercial. They were mainly phase IV, multicentre national, and unmasked controlled trials, compared to the commercial trials that were mainly phase II or III, multicentre international, and double-blind masked trials. The commercial trials were registered and published more often than noncommercial trials. More funding for noncommercial research is still needed. The results of the research, commercial or noncommercial, should be disseminated in order not to compromise either its scientific or its social value. © 2018 The British Pharmacological Society.
At the signing of the ITER EDA Agreement on July, 1992, each of the Parties presented to the Director General the names of their designated members of the ITER Council. Upon receiving those names, the Director General stated that the ITER Engineering Design Activities were ''ready to begin''. The next step in this process was the convening of the first meeting of the ITER Council. The first meeting of the Council, held in Vienna, was opened by Director General Hans Blix. The second meeting was held in Moscow, the formal seat of the Council. This volume presents records of these first two Council meetings and, together with the previous volumes on the text of the Agreement and Protocol 1 and the preparations for their signing respectively, represents essential information on the evolution of the ITER EDA
Sep 26, 2007 ... gene in Deccani breed of sheep, to increase lamb production and ... higher productivity called 'NARI Suwarna' has thus been developed. ... and business of innovation for rural development in the country not only to accelerate.
To report the results of an audit concerning research gaps in clinical trials that were accepted for appraisal in authored and published systematic reviews regarding the application of glass-ionomer cements (GIC) in dental practice Information concerning research gaps in trial precision was extracted, following a framework that included classification of the research gap reasons: 'imprecision of information (results)', 'biased information', 'inconsistency or unknown consistency' and 'not the right information', as well as research gap characterization using PICOS elements: population (P), intervention (I), comparison (C), outcomes (O) and setting (S). Internal trial validity assessment was based on the understanding that successful control for systematic error cannot be assured on the basis of inclusion of adequate methods alone, but also requires empirical evidence about whether such attempt was successful. A comprehensive and interconnected coverage of GIC-related clinical topics was established. The most common reasons found for gaps in trial precision were lack of sufficient trials and lack of sufficient large sample size. Only a few research gaps were ascribed to 'Lack of information' caused by focus on mainly surrogate trial outcomes. According to the chosen assessment criteria, a lack of adequate randomisation, allocation concealment and blinding/masking in trials covering all reviewed GIC topics was noted (selection- and detection/performance bias risk). Trial results appear to be less affected by loss-to-follow-up (attrition bias risk). This audit represents an adjunct of the systematic review articles it has covered. Its results do not change the systematic review's conclusions but highlight existing research gaps concerning the precision and internal validity of reviewed trials in detail. These gaps should be addressed in future GIC-related clinical research.
Full Text Available Abstract Background To report the results of an audit concerning research gaps in clinical trials that were accepted for appraisal in authored and published systematic reviews regarding the application of glass-ionomer cements (GIC in dental practice Methods Information concerning research gaps in trial precision was extracted, following a framework that included classification of the research gap reasons: ‘imprecision of information (results’, ‘biased information’, ‘inconsistency or unknown consistency’ and ‘not the right information’, as well as research gap characterization using PICOS elements: population (P, intervention (I, comparison (C, outcomes (O and setting (S. Internal trial validity assessment was based on the understanding that successful control for systematic error cannot be assured on the basis of inclusion of adequate methods alone, but also requires empirical evidence about whether such attempt was successful. Results A comprehensive and interconnected coverage of GIC-related clinical topics was established. The most common reasons found for gaps in trial precision were lack of sufficient trials and lack of sufficient large sample size. Only a few research gaps were ascribed to ‘Lack of information’ caused by focus on mainly surrogate trial outcomes. According to the chosen assessment criteria, a lack of adequate randomisation, allocation concealment and blinding/masking in trials covering all reviewed GIC topics was noted (selection- and detection/performance bias risk. Trial results appear to be less affected by loss-to-follow-up (attrition bias risk. Conclusion This audit represents an adjunct of the systematic review articles it has covered. Its results do not change the systematic review’s conclusions but highlight existing research gaps concerning the precision and internal validity of reviewed trials in detail. These gaps should be addressed in future GIC-related clinical research.
Shuhatovich, Olga M; Sharman, Mathilde P; Mirabal, Yvette N; Earle, Nan R; Follen, Michele; Basen-Engquist, Karen
In order to improve recruitment for cervical cancer screening trials, it is necessary to analyze the effectiveness of recruitment strategies used in current trials. A trial to test optical spectroscopy for the diagnosis of cervical neoplasia recruited 1000 women from the community; the trial evaluated the emerging technology against Pap smears and colposcopically directed biopsies for cervical dysplasia. We have examined women's reasons for participating as well as the effectiveness and efficiency for each recruitment strategy. Reasons for participation were identified and compared between trials. The recruitment method that resulted in the most contacts was newspaper reportorial coverage and advertising, followed by family and friends, then television news coverage. The most cost-effective method for finding eligible women who attend the research appointment is word of mouth from a family member or friend. Recommendations are given for maximizing the efficiency of recruitment for cervical cancer screening trials.
Full text: A meeting of the ITER Council took place in Toronto, Canada, on 27-28 February 2001 (Canada participates in the ITER EDA as an associate of the EU Party). The delegations to the Council were led by Dr. U. Finzi, Principal Advisor in charge of Fusion R and D in the Directorate-General for Research of the European Commission, Mr. T. Sugawa, Deputy Director-General of the Research and Development Bureau of the Ministry of Education, Culture, Sport, Science and Technology of Japan, and Academician E. Velikhov, President of the RRC ''Kurchatov Institute''. The European delegation was joined by Canadian experts including a representative from the Canadian Department of Natural Resources. The Council heard presentations from Dr. H. Kishimoto on the successful completion of the Explorations concerning future joint implementation of ITER, and from Dr. J.-P. Rager on the ITER International Industry Liaison Meeting held in Toronto in November 2000. Having noted statements of Parties' status, in particular concerning the readiness to start negotiations and the progress toward site offers, the Council encouraged the Parties to pursue preparations toward future implementation of ITER along the general lines proposed in the Explorers' final report. The Council also noted the readiness the of the RF and EU Parties to instruct specified current JCT members to remain at their places of assignment after the end of the EDA, in preparation for a transition to the Co-ordinated Technical Activities foreseen as support to ITER negotiations. The Council was pleased to hear that meetings with the Director of the ITER Parties' Designated Safety Representatives had started, and commended the progress toward achieving timely licensing processes with a good common understanding. The Council noted with appreciation the Director's view that no difficulties of principle in the licensing approach had been identified during the informal discussions with the regulatory representatives and
Lauer, Michael S; Gordon, David; Wei, Gina; Pearson, Gail
Randomized clinical trials and large-scale, cohort studies continue to have a critical role in generating evidence in cardiovascular medicine; however, the increasing concern is that ballooning costs threaten the clinical trial enterprise. In this Perspectives article, we discuss the changing landscape of clinical research, and clinical trials in particular, focusing on reasons for the increasing costs and inefficiencies. These reasons include excessively complex design, overly restrictive inclusion and exclusion criteria, burdensome regulations, excessive source-data verification, and concerns about the effect of clinical research conduct on workflow. Thought leaders have called on the clinical research community to consider alternative, transformative business models, including those models that focus on simplicity and leveraging of digital resources. We present some examples of innovative approaches by which some investigators have successfully conducted large-scale, clinical trials at relatively low cost. These examples include randomized registry trials, cluster-randomized trials, adaptive trials, and trials that are fully embedded within digital clinical care or administrative platforms.
Stéphanie J.E. Becker
Younger patients with no college education, who believe their health can be controlled, are more likely to miss a research appointment when enrolled in a randomized placebo injection-controlled trial.
Drowos, Joanna; Baker, Suzanne; Harrison, Suzanne Leonard; Minor, Suzanne; Chessman, Alexander W; Baker, Dennis
Community-based faculty play a large role in training medical students nationwide and require faculty development. The authors hypothesized that positive relationships exist between clerkships paying preceptors and requiring faculty development, and between protected clerkship directors' time and delivering face-to-face preceptor training, as well as with the number or length of community-based preceptor visits. Through under standing the quantity, delivery methods, barriers, and institutional support for faculty development provided to community-based preceptors teaching in family medicine clerkships, best practices can be developed. Data from the 2015 Council of Academic Family Medicine's Educational Research Alliance survey of Family Medicine Clerkship Directors were analyzed. The cross-sectional survey of clerkship directors is distributed annually to institutional representatives of U.S. and Canadian accredited medical schools. Survey questions focused on the requirements, delivery methods, barriers, and institutional support available for providing faculty development to community-based preceptors. Paying community-based preceptors was positively correlated with requiring faculty development in family medicine clerkships. The greatest barrier to providing faculty development was community-based preceptor time availability; however, face-to-face methods remain the most common delivery strategy. Many family medicine clerkship directors perform informal or no needs assessment in developing faculty development topics for community-based faculty. Providing payment to community preceptors may allow schools to enhance faculty development program activities and effectiveness. Medical schools could benefit from constructing a formal curriculum for faculty development, including formal preceptor needs assessment and program evaluation. Clerkship directors may consider recruiting and retaining community-based faculty by employing innovative faculty development delivery
Handlos, Line Neerup; Chakraborty, Hrishikesh; Sen, Pranab Kumar
To summarize and evaluate all publications including cluster-randomized trials used for maternal and child health research in developing countries during the last 10 years. METHODS: All cluster-randomized trials published between 1998 and 2008 were reviewed, and those that met our criteria...... for inclusion were evaluated further. The criteria for inclusion were that the trial should have been conducted in maternal and child health care in a developing country and that the conclusions should have been made on an individual level. Methods of accounting for clustering in design and analysis were......, and the trials generally improved in quality. CONCLUSIONS: Shortcomings exist in the sample-size calculations and in the analysis of cluster-randomized trials conducted during maternal and child health research in developing countries. Even though there has been improvement over time, further progress in the way...
Introduction Governments in different countries have committed to better use of evidence from research in policy. Although many programmes are directed at assisting agencies to better use research, there have been few tests of the effectiveness of such programmes. This paper describes the protocol for SPIRIT (Supporting Policy In health with Research: an Intervention Trial), a trial designed to test the effectiveness of a multifaceted programme to build organisational capacity for the use of research evidence in policy and programme development. The primary aim is to determine whether SPIRIT results in an increase in the extent to which research and research expertise is sought, appraised, generated and used in the development of specific policy products produced by health policy agencies. Methods and analysis A stepped wedge cluster randomised trial involving six health policy agencies located in Sydney, Australia. Policy agencies are the unit of randomisation and intervention. Agencies were randomly allocated to one of three start dates (steps) to receive the 1-year intervention programme, underpinned by an action framework. The SPIRIT intervention is tailored to suit the interests and needs of each agency and includes audit, feedback and goal setting; a leadership programme; staff training; the opportunity to test systems to assist in the use of research in policies; and exchange with researchers. Outcome measures will be collected at each agency every 6 months for 30 months (starting at the beginning of step 1). Ethics and dissemination Ethics approval was granted by the University of Western Sydney Human Research and Ethics Committee HREC Approval H8855. The findings of this study will be disseminated broadly through peer-reviewed publications and presentations at conferences and used to inform future strategies. PMID:24989620
Garcia-Garcia, Hector M; McFadden, Eugène P; Farb, Andrew; Mehran, Roxana; Stone, Gregg W; Spertus, John; Onuma, Yoshinobu; Morel, Marie-Angèle; van Es, Gerrit-Anne; Zuckerman, Bram; Fearon, William F; Taggart, David; Kappetein, Arie-Pieter; Krucoff, Mitchell W; Vranckx, Pascal; Windecker, Stephan; Cutlip, Donald; Serruys, Patrick W
The Academic Research Consortium (ARC)-2 initiative revisited the clinical and angiographic end point definitions in coronary device trials, proposed in 2007, to make them more suitable for use in clinical trials that include increasingly complex lesion and patient populations and incorporate novel devices such as bioresorbable vascular scaffolds. In addition, recommendations for the incorporation of patient-related outcomes in clinical trials are proposed. Academic Research Consortium-2 is a collaborative effort between academic research organizations in the United States and Europe, device manufacturers, and European, US, and Asian regulatory bodies. Several in-person meetings were held to discuss the changes that have occurred in the device landscape and in clinical trials and regulatory pathways in the last decade. The consensus-based end point definitions in this document are endorsed by the stakeholders of this document and strongly advocated for clinical trial purposes. This Academic Research Consortium-2 document provides further standardization of end point definitions for coronary device trials, incorporating advances in technology and knowledge. Their use will aid interpretation of trial outcomes and comparison among studies, thus facilitating the evaluation of the safety and effectiveness of these devices.
[International regulation of ethics committees on biomedical research as protection mechanisms for people: analysis of the Additional Protocol to the Convention on Human Rights and Biomedicine, concerning Biomedical Research of the Council of Europe].
de Lecuona, Itziar
The article explores and analyses the content of the Council of Europe's Additional Protocol to the Convention on Human Rights and Biomedicine concerning Biomedical Research regarding the standard legal instrument in biomedical research, issued by an international organization with leadership in bioethics. This implies ethics committees are mechanisms of protection of humans in biomedical research and not mere bureaucratic agencies and that a sound inescapable international regulatory framework exists for States to regulate biomedical research. The methodology used focuses on the analysis of the background, the context in which it is made and the nature and scope of the Protocol. It also identifies and analyses the characteristics and functions of ethics committees in biomedical research and, in particular, the information that should be provided to this bodies to develop their functions previously, during and at the end of research projects. This analysis will provide guidelines, suggestions and conclusions for the awareness and training of members of these committees in order to influence the daily practice. This paper may also be of interest to legal practitioners who work in different areas of biomedical research. From this practical perspective, the article examines the legal treatment of the Protocol to meet new challenges and classic issues in research: the treatment of human biological samples, the use of placebos, avoiding double standards, human vulnerability, undue influence and conflicts of interest, among others. Also, from a critical view, this work links the legal responses to develop work procedures that are required for an effective performance of the functions assigned of ethics committees in biomedical research. An existing international legal response that lacks doctrinal standards and provides little support should, however, serve as a guide and standard to develop actions that allow ethics committees -as key bodies for States- to advance in
Continuing the ITER EDA, two further ITER Council Meetings were held since the publication of ITER EDA documentation series no, 20, namely the ITER Council Meeting on 27-28 February 2001 in Toronto, and the ITER Council Meeting on 18-19 July in Vienna. That Meeting was the last one during the ITER EDA. This volume contains records of these Meetings, including: Records of decisions; List of attendees; ITER EDA status report; ITER EDA technical activities report; MAC report and advice; Final report of ITER EDA; and Press release
2013 Elections to Staff Council Vote! Make your voice heard and be many to elect the new Staff Council. More details on the elections can be found on the Staff Association web site (https://ap-vote.web.cern.ch/elections-2013). Timetable elections Monday 28 October to Monday 11 November, 12:00 am voting Monday 18 and Monday 25 November, publication of the results in Echo Tuesday 19 November, Staff Association Assizes Tuesday 3 December, first meeting of the new Staff Council and election of the new Executive Committee The voting procedure is monitored by the Election Committee.
Pencina, Michael J; Louzao, Darcy M; McCourt, Brian J; Adams, Monique R; Tayyabkhan, Rehbar H; Ronco, Peter; Peterson, Eric D
There are growing calls for sponsors to increase transparency by providing access to clinical trial data. In response, Bristol-Myers Squibb and the Duke Clinical Research Institute have collaborated on a new initiative, Supporting Open Access to Researchers. The aim is to facilitate open sharing of Bristol-Myers Squibb trial data with interested researchers. Key features of the Supporting Open Access to Researchers data sharing model include an independent review committee that ensures expert consideration of each proposal, stringent data deidentification/anonymization and protection of patient privacy, requirement of prespecified statistical analysis plans, and independent review of manuscripts before submission for publication. We believe that these approaches will promote open science by allowing investigators to verify trial results as well as to pursue interesting secondary uses of trial data without compromising scientific integrity. Copyright © 2015 Elsevier Inc. All rights reserved.
Shimizu, Reiko; Ogata, Katsuhisa; Tamaura, Akemi; Kimura, En; Ohata, Maki; Takeshita, Eri; Nakamura, Harumasa; Takeda, Shin'ichi; Komaki, Hirofumi
Duchenne muscular dystrophy (DMD) is the most commonly inherited neuromuscular disease. Therapeutic agents for the treatment of rare disease, namely "orphan drugs", have recently drawn the attention of researchers and pharmaceutical companies. To ensure the successful conduction of clinical trials to evaluate novel treatments for patients with rare diseases, an appropriate infrastructure is needed. One of the effective solutions for the lack of infrastructure is to establish a network of rare diseases. To accomplish the conduction of clinical trials in Japan, the Muscular dystrophy clinical trial network (MDCTN) was established by the clinical research group for muscular dystrophy, including the National Center of Neurology and Psychiatry, as well as national and university hospitals, all which have a long-standing history of research cooperation. Thirty-one medical institutions (17 national hospital organizations, 10 university hospitals, 1 national center, 2 public hospitals, and 1 private hospital) belong to this network and collaborate to facilitate clinical trials. The Care and Treatment Site Registry (CTSR) calculates and reports the proportion of patients with neuromuscular diseases in the cooperating sites. In total, there are 5,589 patients with neuromuscular diseases in Japan and the proportion of patients with each disease is as follows: DMD, 29 %; myotonic dystrophy type 1, 23 %; limb girdle muscular dystrophy, 11 %; Becker muscular dystrophy, 10 %. We work jointly to share updated health care information and standardized evaluations of clinical outcomes as well. The collaboration with the patient registry (CTSR), allows the MDCTN to recruit DMD participants with specific mutations and conditions, in a remarkably short period of time. Counting with a network that operates at a national level is important to address the corresponding national issues. Thus, our network will be able to contribute with international research activity, which can lead to
London, Alex John; Carlisle, Benjamin
Phase IV studies are often criticized for poor scientific standards. Yet they provide an important resource for addressing evidence shortfalls in drug safety, comparative effectiveness, and real-world utility. Current research ethics policies, and contemplated revisions to them, do not provide an adequate framework for preventing social harms that result from poor post-marketing research practice. Rather than focus exclusively on the welfare and interests of human volunteers, research policies and ethics should also safeguard the integrity of the research enterprise as a system for producing reliable medical evidence. We close by briefly describing how an integrity framework might be implemented for phase IV studies. PMID:22556237
Full Text Available Abstract Background Following the successful introduction of five topic-specific research networks in the UK, the Comprehensive Local Research Network (CLRN was established in 2008 in order to provide a blanket level of support across the whole country regardless of the clinical discipline. The role of the CLRN was to facilitate recruitment into clinical trials, and to encourage greater engagement in research throughout the National Health Service (NHS. Methods This report evaluates the impact of clinical research networks in supporting clinical trials in the UK, with particular reference to our experiences from two non-commercial dermatology trials. It covers our experience of engaging with the CLRN (and other research networks using two non-commercial dermatology trials as case studies. We present the circumstances that led to our approach to the research networks for support, and the impact that this support had on the delivery of these trials. Results In both cases, recruitment was boosted considerably following the provision of additional support, although other factors such as the availability of experienced personnel, and the role of advertising and media coverage in promoting the trials were also important in translating this additional resource into increased recruitment. Conclusions Recruitment into clinical trials is a complex task that can be influenced by many factors. A world-class clinical research infrastructure is now in place in England (with similar support available in Scotland and Wales, and it is the responsibility of the research community to ensure that this unique resource is used effectively and responsibly.
U.S. Department of Health & Human Services — Decisions of the Departmental Appeals Board's Medicare Appeals Council involving claims for entitlement to Medicare and individual claims for Medicare coverage and...
Allegheny County / City of Pittsburgh / Western PA Regional Data Center — This dataset portrays the boundaries of the County Council Districts in Allegheny County. The dataset is based on municipal boundaries and City of Pittsburgh ward...
Records of the 8. ITER Council Meeting (IC-8), held on 26-27 July 1995, in San Diego, USA, and the 9. ITER Council Meeting (IC-9) held on 12-13 December 1995, in Garching, Germany, are presented, giving essential information on the evolution of the ITER Engineering Design Activities (EDA) and the ITER Interim Design Report Package and Relevant Documents. Figs, tabs
This volume contains documents of the 13th and the 14th ITER council meeting as well as of the 1st extraordinary ITER council meeting. Documents of the ITER meetings held in Vienna and Yokohama during 1998 are also included. The contents include an outline of the ITER objectives, the ITER parameters and design overview as well as operating scenarios and plasma performance. Furthermore, design features, safety and environmental characteristics are given
French, Helen P
Osteoarthritis (OA) of the hip is a major cause of functional disability and reduced quality of life. Management options aim to reduce pain and improve or maintain physical functioning. Current evidence indicates that therapeutic exercise has a beneficial but short-term effect on pain and disability, with poor long-term benefit. The optimal content, duration and type of exercise are yet to be ascertained. There has been little scientific investigation into the effectiveness of manual therapy in hip OA. Only one randomized controlled trial (RCT) found greater improvements in patient-perceived improvement and physical function with manual therapy, compared to exercise therapy.
Today concludes a very busy week for Council. As you’ll have seen from the press release this morning, Council elected a new President, who will take up his mandate on 1 January along with the new management team, which was also approved by Council yesterday. You’ll find full details of the incoming Director-General’s management team and structures here. Completing the configuration for the immediate future, Council also approved the medium term plan, along with the budget for 2016. In other Council business, two complete applications for Associate Membership were discussed. Following an earlier letter, India’s complete application was received and considered by Council. Consequently, a fact-finding mission has been established to report back before the end of the year. A new application was also received from Azerbaijan, with a fact-finding mission to be established. India’s involvement with CERN goes back to the 1970s, and the country...
26th May 2011 -Delegate to CERN Open Council sessions and European Commission Head of Unit for Joint Programming European Research Area, DG Research and Innovation R. Lečbychová visiting the CERN Control Centre with M. Pojer, accompanied by CERN S. Stavrev.
26th May 2011 -Delegate to CERN Open Council sessions and European Commission Head of Unit for Joint Programming European Research Area, DG Research and Innovation R. Lečbychová visiting the CERN Control Centre with M. Pojer, accompanied by CERN S. Stavrev.
10 March 2008 - Swedish Minister for Higher Education and Research L. Leijonborg signing the guest book with CERN Chef Scientific Officer J. Engelen, followed by the signature of the Swedish Computing Memorandum of Understanding by the Director General of the Swedish Research Council P. Ömling.
10 March 2008 - Swedish Minister for Higher Education and Research L. Leijonborg signing the guest book with CERN Chef Scientific Officer J. Engelen, followed by the signature of the Swedish Computing Memorandum of Understanding by the Director General of the Swedish Research Council P. Ömling.
Kearney, Anna; Williamson, Paula; Young, Bridget; Bagley, Heather; Gamble, Carrol; Denegri, Simon; Muir, Delia; Simon, Natalie A; Thomas, Stephen; Elliot, Jim T; Bulbeck, Helen; Crocker, Joanna C; Planner, Claire; Vale, Claire; Clarke, Mike; Sprosen, Tim; Woolfall, Kerry
Despite increasing international interest, there is a lack of evidence about the most efficient, effective and acceptable ways to implement patient and public involvement (PPI) in clinical trials. To identify the priorities of UK PPI stakeholders for methodological research to help resolve uncertainties about PPI in clinical trials. A modified Delphi process including a two round online survey and a stakeholder consensus meeting. In total, 237 people registered of whom 219 (92%) completed the first round. One hundred and eighty-seven of 219 (85%) completed the second; 25 stakeholders attended the consensus meeting. Round 1 of the survey comprised 36 topics; 42 topics were considered in round 2 and at the consensus meeting. Approximately 96% of meeting participants rated the top three topics as equally important. These were as follows: developing strong and productive working relationships between researchers and PPI contributors; exploring PPI practices in selecting trial outcomes of importance to patients; and a systematic review of PPI activity to improve the accessibility and usefulness of trial information (eg participant information sheets) for participants. The prioritized methodological research topics indicate important areas of uncertainty about PPI in trials. Addressing these uncertainties will be critical to enhancing PPI. Our findings should be used in the planning and funding of PPI in clinical trials to help focus research efforts and minimize waste. © 2017 The Authors Health Expectations Published by John Wiley & Sons Ltd.
White, R R; Roman-Garcia, Y; Firkins, J L; VandeHaar, M J; Armentano, L E; Weiss, W P; McGill, T; Garnett, R; Hanigan, M D
Evaluation of ration balancing systems such as the National Research Council (NRC) Nutrient Requirements series is important for improving predictions of animal nutrient requirements and advancing feeding strategies. This work used a literature data set (n = 550) to evaluate predictions of total-tract digested neutral detergent fiber (NDF), fatty acid (FA), crude protein (CP), and nonfiber carbohydrate (NFC) estimated by the NRC (2001) dairy model. Mean biases suggested that the NRC (2001) lactating cow model overestimated true FA and CP digestibility by 26 and 7%, respectively, and under-predicted NDF digestibility by 16%. All NRC (2001) estimates had notable mean and slope biases and large root mean squared prediction error (RMSPE), and concordance (CCC) ranged from poor to good. Predicting NDF digestibility with independent equations for legumes, corn silage, other forages, and nonforage feeds improved CCC (0.85 vs. 0.76) compared with the re-derived NRC (2001) equation form (NRC equation with parameter estimates re-derived against this data set). Separate FA digestion coefficients were derived for different fat supplements (animal fats, oils, and other fat types) and for the basal diet. This equation returned improved (from 0.76 to 0.94) CCC compared with the re-derived NRC (2001) equation form. Unique CP digestibility equations were derived for forages, animal protein feeds, plant protein feeds, and other feeds, which improved CCC compared with the re-derived NRC (2001) equation form (0.74 to 0.85). New NFC digestibility coefficients were derived for grain-specific starch digestibilities, with residual organic matter assumed to be 98% digestible. A Monte Carlo cross-validation was performed to evaluate repeatability of model fit. In this procedure, data were randomly subsetted 500 times into derivation (60%) and evaluation (40%) data sets, and equations were derived using the derivation data and then evaluated against the independent evaluation data. Models
Fureman, Brandy E; Friedman, Daniel; Baulac, Michel; Glauser, Tracy; Moreno, Jonathan; Dixon-Salazar, Tracy; Bagiella, Emilia; Connor, Jason; Ferry, Jim; Farrell, Kathleen; Fountain, Nathan B; French, Jacqueline A
The randomized controlled trial is the unequivocal gold standard for demonstrating clinical efficacy and safety of investigational therapies. Recently there have been concerns raised about prolonged exposure to placebo and ineffective therapy during the course of an add-on regulatory trial for new antiepileptic drug approval (typically ∼6 months in duration), due to the potential risks of continued uncontrolled epilepsy for that period. The first meeting of the Research Roundtable in Epilepsy on May 19-20, 2016, focused on "Reducing placebo exposure in epilepsy clinical trials," with a goal of considering new designs for epilepsy regulatory trials that may be added to the overall development plan to make it, as a whole, safer for participants while still providing rigorous evidence of effect. This topic was motivated in part by data from a meta-analysis showing a 3- to 5-fold increased rate of sudden unexpected death in epilepsy in participants randomized to placebo or ineffective doses of new antiepileptic drugs. The meeting agenda included rationale and discussion of different trial designs, including active-control add-on trials, placebo add-on to background therapy with adjustment, time to event designs, adaptive designs, platform trials with pooled placebo control, a pharmacokinetic/pharmacodynamic approach to reducing placebo exposure, and shorter trials when drug tolerance has been ruled out. The merits and limitations of each design were discussed and are reviewed here. © 2017 American Academy of Neurology.
Salman, Ali; Nguyen, Claire; Lee, Yi-Hui; Cooksey-James, Tawna
To enhance nurses' awareness and competencies in practice and research by reporting the common barriers to participation of minorities in cancer clinical trials and discussing facilitators and useful strategies for recruitment. Several databases were searched for articles published in peer reviewed journals. Some of the barriers to minorities' participation in clinical trials were identified within the cultural social-context of cancer patients. The involvement of community networking was suggested as the most effective strategy for the recruitment of minorities in cancer clinical trials. Using culturally sensitive approaches to enhance ethnic minorities' participation is important for advancing cancer care and eliminating health disparities. Awareness of barriers and potential facilitators to the enrollment of ethnic minority cancer patients may contribute to enhancing nurses' competencies of recruiting ethnic minorities in nursing research, playing efficient roles in cancer clinical trials team, and providing culturally competent quality care.
Joyce, Emer; Givertz, Michael M
The Heart Failure Clinical Research Network (HFN) was established in 2008 on behalf of the NIH National Heart, Lung and Blood Institute, with the primary goal of improving outcomes in heart failure (HF) by designing and conducting high-quality concurrent clinical trials testing interventions across the spectrum of HF. Completed HFN trials have answered several important and relevant clinical questions concerning the safety and efficacy of different decongestive and adjunctive vasodilator therapies in hospitalized acute HF, phosphodiesterase-5 inhibition and nitrate therapies in HF with preserved ejection fraction, and the role of xanthine oxidase inhibition in hyperuricemic HF. These successes, independent of the "positive" or "negative" result of each individual trial, have helped to shape the current clinical care of HF patients and serve as a platform to inform future research directions and trial designs.
Blazeby, Jane; Nasser, Mona; Soares-Weiser, Karla; Sydes, Matthew R.; Zhang, Junhua; Williamson, Paula R
BackgroundMethodological research into the design, conduct, analysis and reporting of trials is essential to optimise the process. UK specialists in the field have established a set of top priorities in aid of this research. These priorities however may not be reflected in the needs of similar research in low to middle income countries (LMICs) with different healthcare provision, resources and research infrastructure. The aim of the study was to identify the top priorities for methodological ...
Full Text Available Abstract Background The sequence of events in a behaviour change trial involves interactions between research participants and the trial process. Taking part in such a study has the potential to influence the behaviour of the participant, and if it does, this can engender bias in trial outcomes. Since participants’ experience has received scant attention, the aim of this study is thus to generate hypotheses about which aspects of the conduct of behaviour change trials might matter most to participants, and thus have potential to alter subsequent behaviours and bias trial outcomes Methods Twenty participants were opportunistically screened for a health compromising behaviour (unhealthy diet, lack of exercise, smoking or alcohol consumption and recruited if eligible. Semi structured face to face interviews were conducted, after going through the usual processes involved in trial recruitment, baseline assessment and randomisation. Participants were given information on the contents of an intervention or control condition in a behaviour change trial, which was not actually implemented. Three months later they returned to reflect on these experiences and whether they had any effect on their behaviour during the intervening period. Data from the latter interview were analysed thematically using a modified grounded theory approach. Results The early processes of trial participation raised awareness of unhealthy behaviours, although most reported having had only fleeting intentions to change their behaviour as a result of taking part in this study, in the absence of interventions. However, careful examination of the accounts revealed evidence of subtle research participation effects, which varied according to the health behaviour, and its perceived social acceptability. Participants’ relationships with the research study were viewed as somewhat important in stimulating thinking about whether and how to make lifestyle changes. Conclusion These
MacNeill, Virginia; Foley, Marian; Quirk, Alan; McCambridge, Jim
The sequence of events in a behaviour change trial involves interactions between research participants and the trial process. Taking part in such a study has the potential to influence the behaviour of the participant, and if it does, this can engender bias in trial outcomes. Since participants' experience has received scant attention, the aim of this study is thus to generate hypotheses about which aspects of the conduct of behaviour change trials might matter most to participants, and thus have potential to alter subsequent behaviours and bias trial outcomes Twenty participants were opportunistically screened for a health compromising behaviour (unhealthy diet, lack of exercise, smoking or alcohol consumption) and recruited if eligible. Semi structured face to face interviews were conducted, after going through the usual processes involved in trial recruitment, baseline assessment and randomisation. Participants were given information on the contents of an intervention or control condition in a behaviour change trial, which was not actually implemented. Three months later they returned to reflect on these experiences and whether they had any effect on their behaviour during the intervening period. Data from the latter interview were analysed thematically using a modified grounded theory approach. The early processes of trial participation raised awareness of unhealthy behaviours, although most reported having had only fleeting intentions to change their behaviour as a result of taking part in this study, in the absence of interventions. However, careful examination of the accounts revealed evidence of subtle research participation effects, which varied according to the health behaviour, and its perceived social acceptability. Participants' relationships with the research study were viewed as somewhat important in stimulating thinking about whether and how to make lifestyle changes. These participants described no dramatic impacts attributable to taking part in
Joseph, Pathma D; Craig, Jonathan C; Tong, Allison; Caldwell, Patrina H Y
The last decade has seen dramatic changes in the regulatory landscape to support more trials involving children, but child-specific challenges and inequitable conduct across income regions persist. The goal of this study was to describe the attitudes and opinions of stakeholders toward trials in children, to inform additional strategies to promote more high-quality, relevant pediatric trials across the globe. Key informant semi-structured interviews were conducted with stakeholders (researchers, regulators, and sponsors) who were purposively sampled from low- to middle-income countries and high-income countries. The transcripts were thematically analyzed. Thirty-five stakeholders from 10 countries were interviewed. Five major themes were identified: addressing pervasive inequities (paucity of safety and efficacy data, knowledge disparities, volatile environment, double standards, contextual relevance, market-driven forces, industry sponsorship bias and prohibitive costs); contending with infrastructural barriers (resource constraints, dearth of pediatric trial expertise, and logistical complexities); navigating complex ethical and regulatory frameworks ("draconian" oversight, ambiguous requirements, exploitation, excessive paternalism and precariousness of coercion versus volunteerism); respecting uniqueness of children (pediatric research paradigms, child-appropriate approaches, and family-centered empowerment); and driving evidence-based child health (advocacy, opportunities, treatment access, best practices, and research prioritization). Stakeholders acknowledge that changes in the regulatory environment have encouraged more trials in children, but they contend that inequities and political, regulatory, and resource barriers continue to exist. Embedding trials as part of routine clinical care, addressing the unique needs of children, and streamlining regulatory approvals were suggested. Stakeholders recommended increasing international collaboration
May, Roel; Bevanger, Kjetil; Dijk, Jiska Van; Petrin, Zlatko; Brende, Hege
Renewable energy production is seen as a key factor for reduction of climate emissions; however further development of landscapes and seascapes may impact the environment on top of existing pressures. Norway has committed to reduce emissions, and major efforts are put into technological and environmental research to provide knowledge and solutions to meet these challenges. This report synthesizes the knowledge on environmental impacts of renewable energy acquired through the EFFEN, EFFEKT and RENERGI programmes run by the Research Council of Norway; especially from the Centre for Environmental Design of Renewable Energy (CEDREN), as one of the centres for environmental-friendly energy research (CEER). Due to extensive water resources Norway was among the first countries to base its energy system on hydropower; already from the late 19th century. Today, approximately 62% of Norway's energy supply comes from hydropower. Norway has ratified EUs Renewables Directive and committed to a target of generating 67.5% from renewable sources. Because the majority of the large river systems were already regulated in the 1960s, wind power is expected to grow extensively to reach this target. With the current development of onshore and offshore wind power and the extension of associated power transmission, environmental considerations will evolve rapidly. Research on environmental impacts of hydropower production prioritized the Atlantic salmon for many years, also due to its value for recreation and tourism. Currently Norway is at the very front of generating knowledge on salmon, empirical studies and development of mitigation measures. Research on hydropower production in regulated rivers has revealed major bottlenecks for salmon production and survival, with varying impacts at different life stages. Research results from EnviDORR and EnviPEAK have provided solutions to ensure production of salmon despite hydropower development. This shows the possibility of reconciling
Over the last decade, the status of the randomized controlled trial (RCT), hallmark of evidence-based medicine (research), has been growing strongly in general practice, social work and public health. But this type of research is only practicable under strictly controlled and well-defined settings
Ahmed, W.; Qureshi, H.; Arif, A.; Alam, S.E.
To determine the frequency and pattern of Hepatitis B and C over the past twenty one years, in a liver research unit of Karachi. Retrospective analysis of the records of PMRC, Research Centre, Jinnah Postgraduate Medical Centre, Karachi, from 1987 to 2007 were reviewed. A special flow sheet was made where information of all patients with viral liver disease was entered. Patients having complete information of viral markers were included in the analysis. Cases with HBsAg, Anti HBc IgM positive and raised ALT were considered as acute Hepatitis B. HBs Ag/ Anti HBc IgG positive were considered as chronic Hepatitis B. Delta antibody positive with or without HBsAg were considered as Delta Hepatitis. Anti HCV positive and raised ALT more than ten times for less than 6 months were considered as acute Hepatitis C, whereas Anti HCV and HCV-RNA positive with or without raised ALT for more than six months were considered as chronic Hepatitis C. Anti HEV IgM and Anti HAV IgM positive were considered as acute Hepatitis E and A respectively. A total of 5193 cases fulfilling all criteria of viral hepatitis were seen in the past 21 years. Of the total 3247 (62.5 %) were males and 1946 (37.5 %) females giving a male to female ratio of 1.7:1 Hepatitis C was the most common infection seen in 2896 cases (55.8 %), followed by Hepatitis B in 1691 cases (32.6 %). Seventy five percent cases of Hepatitis B were males and 25 % females while 55% Hepatitis C cases were males and 45 % females. Hepatitis B was seen a decade earlier in different age groups than hepatitis C. Overall, out of the total 5193 cases, 2294 (44.2%) were of chronic hepatitis, 1430 (27.5%) cirrhosis, 1083 (20.8%) carriers and 346 (6.7%) had acute hepatitis (hepatitis B; 214 (61.8%), hepatitis C; 21 (6.0%). While hepatitis B and hepatitis C both were present in 3 (1.3%). Hepatitis E was 70 (20.2%) hepatitis A 12 (3.5%) and all markers were negative in 26 (7.5%) cases). Forty cases (0.8%) were of Hepatocellular carcinoma
Dawson, Liza; Zwerski, Sheryl
This article seeks to advance ethical dialogue on choosing standards of prevention in clinical trials testing improved biomedical prevention methods for HIV. The stakes in this area of research are high, given the continued high rates of infection in many countries and the budget limitations that have constrained efforts to expand treatment for all who are currently HIV-infected. New prevention methods are still needed; at the same time, some existing prevention and treatment interventions have been proven effective but are not yet widely available in the countries where they most urgently needed. The ethical tensions in this field of clinical research are well known and have been the subject of extensive debate. There is no single clinical trial design that can optimize all the ethically important goals and commitments involved in research. Several recent articles have described the current ethical difficulties in designing HIV prevention trials, especially in resource limited settings; however, there is no consensus on how to handle clinical trial design decisions, and existing international ethical guidelines offer conflicting advice. This article acknowledges these deep ethical dilemmas and moves beyond a simple descriptive approach to advance an organized method for considering what clinical trial designs will be ethically acceptable for HIV prevention trials, balancing the relevant criteria and providing justification for specific design decisions. Published 2014. This article is a U.S. Government work and is in the public domain in the USA.
Allen, Michele L; Garcia-Huidobro, Diego; Bastian, Tiana; Hurtado, G Ali; Linares, Roxana; Svetaz, María Veronica
Participatory research (PR) trials aim to achieve the dual, and at times competing, demands of producing an intervention and research process that address community perspectives and priorities, while establishing intervention effectiveness. To identify research and community priorities that must be reconciled in the areas of collaborative processes, study design and aim and study implementation quality in order to successfully conduct a participatory trial. We describe how this reconciliation was approached in the smoking prevention participatory trial Padres Informados/Jovenes Preparados (Informed Parents/Prepared Youth) and evaluate the success of our reconciled priorities. Data sources to evaluate success of the reconciliations included a survey of all partners regarding collaborative group processes, intervention participant recruitment and attendance and surveys of enrolled study participants assessing intervention outcomes. While we successfully achieved our reconciled collaborative processes and implementation quality goals, we did not achieve our reconciled goals in study aim and design. Due in part to the randomized wait-list control group design chosen in the reconciliation process, we were not able to demonstrate overall efficacy of the intervention or offer timely services to families in need of support. Achieving the goals of participatory trials is challenging but may yield community and research benefits. Innovative research designs are needed to better support the complex goals of participatory trials. © The Author 2017. Published by Oxford University Press. All rights reserved. For permissions, please e-mail: firstname.lastname@example.org.
Rubin, P.; Keys, H.; Salazar, O.
The goals of the research mission are clear: (1) to explore in a logical, systematic, organized, and coordinated fashion those potential therapeutic advances that show promise; (2) to identify, in the laboratory, those models that predict successful combinations of treatment modes; (3) to search for ultimate treatment of programs that improve the therapeutic ratio. The modalities, innovations in treatment, and logic exist; it now rests with meticulous science to show carefully the directions that clinical research should follow in pursuit of the ultimate objective of improving cancer cure rates with less toxicity
composition of CABs, leadership qualities, among others. This course places emphasis in areas that ICHGCP ... interests of the community function as a source of leadership in the partnerships between researchers and the .... This implied that the idea of volunteering or volunteer work during CAB training was not properly ...
Gewandter, Jennifer S; Dworkin, Robert H; Turk, Dennis C
Although certain risk factors can identify individuals who are most likely to develop chronic pain, few interventions to prevent chronic pain have been identified. To facilitate the identification of preventive interventions, an IMMPACT meeting was convened to discuss research design considerations...
Gobbini, Elisa; Pilotto, Sara; Pasello, Giulia; Polo, Valentina; Di Maio, Massimo; Arizio, Francesca; Galetta, Domenico; Petrillo, Patrizia; Chiari, Rita; Matocci, Roberta; Di Costanzo, Alessandro; Di Stefano, Teresa Severina; Aglietta, Massimo; Cagnazzo, Celeste; Sperduti, Isabella; Bria, Emilio; Novello, Silvia
Contract research organization (CRO) support is largely included in clinical trial management, although its effect in terms of time savings and benefit has not yet been quantified. We performed a retrospective multicenter analysis of lung cancer trials to explore differences in term of trial activation timelines and accrual for studies with and without CRO involvement. Results regarding study timelines from feasibility data to first patient enrollment were collected from 7 Italian thoracic oncology departments. The final accruals (screened/enrolled patients) are reported. We considered CRO/sponsor-administered and CRO-free trials according to who was responsible for the management of the crucial setup phases. Of 113 trials, 62 (54.9%) were CRO-administered, 34 (30.1%) were sponsor-administered, and 17 (15.0%) were CRO-free. The median time from feasibility invitation to documentation obtainment was 151 days in the CRO-administered trials versus 128 in the sponsor-administered and 120 in the CRO-free trials. The time from document submission to contract signature was 142 days in the CRO-administered versus 128 in the sponsor-administered and 132 in the CRO-free trials. The time from global accrual opening to first patient enrollment was 247 days for the CRO-administered versus 194 in the sponsor-administered and 151 in the CRO-free trials. No significant differences were observed in terms of the median overall timeline: 21 months in the CRO-administered, 15 in the sponsor-administered, and 18 months in the CRO-free studies (P = .29). Although no statistically significant differences were identified, the results of our analysis support the idea that bureaucratic procedures might require more time in CRO-administered trials than in sponsor-administered and CRO-free studies. This bureaucratic delay could negatively affect Italian patients' screening and enrollment compared with other countries. Copyright © 2017 Elsevier Inc. All rights reserved.
Giménez, Nuria; Pedrazas, David; Redondo, Susana; Quintana, Salvador
Adequate information for patients and respect for their autonomy are mandatory in research. This article examined insights of researchers, patients and general practitioners (GPs) on the informed consent process in clinical trials, and the role of the GP. A cross-sectional study using three questionnaires, informed consent reviews, medical records, and hospital discharge reports. GPs, researchers and patients involved in clinical trials. Included, 504 GPs, 108 researchers, and 71 patients. Consulting the GP was recommended in 50% of the informed consents. Participation in clinical trials was shown in 33% of the medical records and 3% of the hospital discharge reports. GPs scored 3.54 points (on a 1-10 scale) on the assessment of the information received by the principal investigator. The readability of the informed consent sheet was rated 8.03 points by researchers, and the understanding was rated 7.68 points by patients. Patient satisfaction was positively associated with more time for reflection. GPs were not satisfied with the information received on the participation of patients under their in clinical trials. Researchers were satisfied with the information they offered to patients, and were aware of the need to improve the information GPs received. Patients collaborated greatly towards biomedical research, expressed satisfaction with the overall process, and minimised the difficulties associated with participation. Copyright © 2015 Elsevier España, S.L.U. All rights reserved.
Full Text Available Abstract Background Osteoarthritis (OA of the hip is a major cause of functional disability and reduced quality of life. Management options aim to reduce pain and improve or maintain physical functioning. Current evidence indicates that therapeutic exercise has a beneficial but short-term effect on pain and disability, with poor long-term benefit. The optimal content, duration and type of exercise are yet to be ascertained. There has been little scientific investigation into the effectiveness of manual therapy in hip OA. Only one randomized controlled trial (RCT found greater improvements in patient-perceived improvement and physical function with manual therapy, compared to exercise therapy. Methods and design An assessor-blind multicentre RCT will be undertaken to compare the effect of a combination of manual therapy and exercise therapy, exercise therapy only, and a waiting-list control on physical function in hip OA. One hundred and fifty people with a diagnosis of hip OA will be recruited and randomly allocated to one of 3 groups: exercise therapy, exercise therapy with manual therapy and a waiting-list control. Subjects in the intervention groups will attend physiotherapy for 6–8 sessions over 8 weeks. Those in the control group will remain on the waiting list until after this time and will then be re-randomised to one of the two intervention groups. Outcome measures will include physical function (WOMAC, pain severity (numerical rating scale, patient perceived change (7-point Likert scale, quality of life (SF-36, mood (hospital anxiety and depression scale, patient satisfaction, physical activity (IPAQ and physical measures of range of motion, 50-foot walk and repeated sit-to stand tests. Discussion This RCT will compare the effectiveness of the addition of manual therapy to exercise therapy to exercise therapy only and a waiting-list control in hip OA. A high quality methodology will be used in keeping with CONSORT guidelines. The
The June meeting of Council is always a very busy one, having approval of the next year’s budget and the MTP as fixed agenda points. This year in addition, we had discussions on enlargement, as well as on the pension fund. I’d like to use this message to bring you up to date on all of those matters. I’ll begin with the good news that the 2015 budget and MTP were recommended for approval by Finance Committee on Wednesday, and approved by Council on Thursday. This is extremely good news, and a solid vote of confidence from Council in the current economic situation. Coupled with that, I am pleased to report that at the half way stage of 2014, some 89% of budget contributions for the year have been received. Turning now to enlargement, I can inform you that the task force that went to Pakistan came back with a positive report, and as a consequence Council has authorised us to finalise discussion with Pakistan for Associate Membership. Council also authoris...
Velimirov, Alberta; Huber, Machteld; Lauridsen, Charlotte
Feeding experiments comparing organically and conventionally produced food are performed to assess the overall impact on the animals' health as a model for the effects experienced by the human consumers. These experiments are based on systems research and characterized by their focus on production...... research is not just about simple cause-effect chains, but rather about the pluralism of interactions in biological networks; therefore, the interpretation of the outcome of whole food experiments is difficult. Furthermore, the test diets of organic and conventional origin can be constituted in different...... methods, whole food testing and procedures in accordance with the terms of organic farming. A short review of such experiments shows that the majority of these tests revealed effects of the organically produced feed on health parameters such as reproductive performance and immune responses. Systems...
Dunn, Graham; Emsley, Richard; Liu, Hanhua; Landau, Sabine; Green, Jonathan; White, Ian; Pickles, Andrew
The development of the capability and capacity to evaluate the outcomes of trials of complex interventions is a key priority of the National Institute for Health Research (NIHR) and the Medical Research Council (MRC). The evaluation of complex treatment programmes for mental illness (e.g. cognitive-behavioural therapy for depression or psychosis) not only is a vital component of this research in its own right but also provides a well-established model for the evaluation of complex interventions in other clinical areas. In the context of efficacy and mechanism evaluation (EME) there is a particular need for robust methods for making valid causal inference in explanatory analyses of the mechanisms of treatment-induced change in clinical outcomes in randomised clinical trials. The key objective was to produce statistical methods to enable trial investigators to make valid causal inferences about the mechanisms of treatment-induced change in these clinical outcomes. The primary objective of this report is to disseminate this methodology, aiming specifically at trial practitioners. The three components of the research were (1) the extension of instrumental variable (IV) methods to latent growth curve models and growth mixture models for repeated-measures data; (2) the development of designs and regression methods for parallel trials; and (3) the evaluation of the sensitivity/robustness of findings to the assumptions necessary for model identifiability. We illustrate our methods with applications from psychological and psychosocial intervention trials, keeping the technical details to a minimum, leaving the reporting of the more theoretical and mathematically demanding results for publication in appropriate specialist journals. We show how to estimate treatment effects and introduce methods for EME. We explain the use of IV methods and principal stratification to evaluate the role of putative treatment effect mediators and therapeutic process measures. These results are
Archer, Stephanie Wilson; Carlo, Waldemar A.; Truog, William E.; Stevenson, David K.; Van Meurs, Krisa P.; Sánchez, Pablo J.; Das, Abhik; Devaskar, Uday; Nelin, Leif D.; Petrie Huitema, Carolyn M.; Crawford, Margaret M.; Higgins, Rosemary D.
Unpublished results can bias biomedical literature, favoring positive over negative findings, primary over secondary analyses, and can lead to duplicate studies that unnecessarily endanger subjects and waste resources. The Neonatal Research Network’s (NRN) publication policies for approving, reviewing, and tracking abstracts and papers work to combat these problems. In 2003, the NRN restricted investigators with unfinished manuscripts from proposing new ones and in 2010, urged authors to comp...
Over the past decade, the management of clinical trials of pharmaceuticals has become a veritable industry, as evidenced by the emergence and proliferation of contract research organizations (CROs) that co-ordinate and monitor trials. This article focuses on work performed by one CRO involved in the introduction of new software, modelled on industrial production processes, into clinical trial practices. It investigates how this new management technique relates to the work performed in the clinic to ensure that trial participants comply with the protocol. Using an analytical distinction between 'classical' management work and invisible work, the article contextualizes the meaning of compliance in the clinic and suggests that the work involved in producing compliance should be taken into consideration by those concerned with validity of trials, as clinical trials are put under private industrial management. The article builds on participant observation at a Swedish university hospital and interviews the nurses, dieticians, doctors and a software engineer, all part of a team involved in pharmaceutical drug trials on a potential obesity drug.
Milani, Alessandra; Mazzocco, Ketti; Stucchi, Sara; Magon, Giorgio; Pravettoni, Gabriella; Passoni, Claudia; Ciccarelli, Chiara; Tonali, Alessandra; Profeta, Teresa; Saiani, Luisa
Few resources are available to quantify clinical trial-associated workload, needed to guide staffing and budgetary planning. The aim of the study is to describe a tool to measure clinical trials nurses' workload expressed in time spent to complete core activities. Clinical trials nurses drew up a list of nursing core activities, integrating results from literature searches with personal experience. The final 30 core activities were timed for each research nurse by an outside observer during daily practice in May and June 2014. Average times spent by nurses for each activity were calculated. The "Nursing Time Required by Clinical Trial-Assessment Tool" was created as an electronic sheet that combines the average times per specified activities and mathematic functions to return the total estimated time required by a research nurse for each specific trial. The tool was tested retrospectively on 141 clinical trials. The increasing complexity of clinical research requires structured approaches to determine workforce requirements. This study provides a tool to describe the activities of a clinical trials nurse and to estimate the associated time required to deliver individual trials. The application of the proposed tool in clinical research practice could provide a consistent structure for clinical trials nursing workload estimation internationally. © 2016 John Wiley & Sons Australia, Ltd.
Records of the third ITER Council Meeting (IC-3), held on 21-22 April 1993, in Tokyo, Japan, and the fourth ITER Council Meeting (IC-4) held on 29 September - 1 October 1993 in San Diego, USA, are presented, giving essential information on the evolution of the ITER Engineering Design Activities (EDA), such as the text of the draft of Protocol 2 further elaborated in ''ITER EDA Agreement and Protocol 2'' (ITER EDA Documentation Series No. 5), recommendations on future work programmes: a description of technology R and D tasks; the establishment of a trust fund for the ITER EDA activities; arrangements for Visiting Home Team Personnel; the general framework for the involvement of other countries in the ITER EDA; conditions for the involvement of Canada in the Euratom Contribution to the ITER EDA; and other attachments as parts of the Records of Decision of the aforementioned ITER Council Meetings
Records of the third ITER Council Meeting (IC-3), held on 21-22 April 1993, in Tokyo, Japan, and the fourth ITER Council Meeting (IC-4) held on 29 September - 1 October 1993 in San Diego, USA, are presented, giving essential information on the evolution of the ITER Engineering Design Activities (EDA), such as the text of the draft of Protocol 2 further elaborated in ``ITER EDA Agreement and Protocol 2`` (ITER EDA Documentation Series No. 5), recommendations on future work programmes: a description of technology R and D tastes; the establishment of a trust fund for the ITER EDA activities; arrangements for Visiting Home Team Personnel; the general framework for the involvement of other countries in the ITER EDA; conditions for the involvement of Canada in the Euratom Contribution to the ITER EDA; and other attachments as parts of the Records of Decision of the aforementioned ITER Council Meetings.
... will receive a report on outreach and research activities associated with the Oculina Bank Experimental...-Based Management Committee will receive an overview of the actions and alternatives currently in draft... documents, review the Council's research plan, develop recommendations relative to Council stock assessment...
Charlesworth Lisa; Perdue Jo; Foster Katharine; Koller Karin; Thomas Kim S; Chalmers Joanne R
Abstract Background Following the successful introduction of five topic-specific research networks in the UK, the Comprehensive Local Research Network (CLRN) was established in 2008 in order to provide a blanket level of support across the whole country regardless of the clinical discipline. The role of the CLRN was to facilitate recruitment into clinical trials, and to encourage greater engagement in research throughout the National Health Service (NHS). Methods This report evaluates the imp...
Escolar, Diana M; Henricson, Erik K; Pasquali, Livia; Gorni, Ksenija; Hoffman, Eric P
Progress in the development of rationally based therapies for Duchenne muscular dystrophy has been accelerated by encouraging multidisciplinary, multi-institutional collaboration between basic science and clinical investigators in the Cooperative International Research Group. We combined existing research efforts in pathophysiology by a gene expression profiling laboratory with the efforts of animal facilities capable of conducting high-throughput drug screening and toxicity testing to identify safe and effective drug compounds that target different parts of the pathophysiologic cascade in a genome-wide drug discovery approach. Simultaneously, we developed a clinical trial coordinating center and an international network of collaborating physicians and clinics where those drugs could be tested in large-scale clinical trials. We hope that by bringing together investigators at these facilities and providing the infrastructure to support their research, we can rapidly move new bench discoveries through animal model screening and into therapeutic testing in humans in a safe, timely and cost-effective setting.
This volume of the ITER EDA Documentation Series presents records of the 12th ITER Council Meeting, IC-12, which took place on 23-24 July, 1997 in Tampere, Finland. The Council received from the Parties (EU, Japan, Russia, US) positive responses on the Detailed Design Report. The Parties stated their willingness to contribute to fulfil their obligations in contributing to the ITER EDA. The summary discussions among the Parties led to the consensus that in July 1998 the ITER activities should proceed for additional three years with a general intent to enable an efficient start of possible, future ITER construction
Croghan, Ivana T; Viker, Steven D; Limper, Andrew H; Evans, Tamara K; Cornell, Alissa R; Ebbert, Jon O; Gertz, Morie A
Research, clinical care, and education are the three cornerstones of academic health centers in the United States. The research climate has always been riddled with ebbs and flows, depending on funding availability. During a time of reduced funding, the number and scope of research studies have been reduced, and in some instances, a field of study has been eliminated. Recent reductions in the research funding landscape have led institutions to explore new ways to continue supporting research. Mayo Clinic in Rochester, MN has developed a clinical trial unit within the Department of Medicine, which provides shared resources for many researchers and serves as a solution for training and mentoring new investigators and study teams. By building on existing infrastructure and providing supplemental resources to existing research, the Department of Medicine clinical trial unit has evolved into an effective mechanism for conducting research. This article discusses the creation of a central unit to provide research support in clinical trials and presents the advantages, disadvantages, and required building blocks for such a unit. Copyright © 2015 Mayo Clinic. Published by Elsevier Inc. All rights reserved.
Sariola, Salla; Ravindran, Deapica; Kumar, Anand; Jeffery, Roger
The World Trade Organisation's Trade Related Intellectual Property Rights [TRIPS] agreement aimed to harmonise intellectual property rights and patent protection globally. In India, the signing of this agreement resulted in a sharp increase in clinical trials since 2005. The Indian government, along with larger Indian pharmaceutical companies, believed that they could change existing commercial research cultures through the promotion of basic research as well as attracting international clinical trials, and thus create an international level, innovation-based drug industry. The effects of the growth of these outsourced and off-shored clinical trials on local commercial knowledge production in India are still unclear. What has been the impact of the increasing scale and commercialisation of clinical research on corporate science in India? In this paper we describe Big-pharmaceuticalisation in India, whereby the local pharmaceutical industry is moving from generic manufacturing to innovative research. Using conceptual frameworks of pharmaceuticalisation and innovation, this paper analyses data from research conducted in 2010-2012 and describes how Contract Research Organisations (CROs) enable outsourcing of randomised control trials to India. Focussing on twenty-five semi-structured interviews CRO staff, we chart the changes in Indian pharmaceutical industry, and implications for local research cultures. We use Big-pharmaceuticalisation to extend the notion of pharmaceuticalisation to describe the spread of pharmaceutical research globally and illustrate how TRIPS has encouraged a concentration of capital in India, with large companies gaining increasing market share and using their market power to rewrite regulations and introduce new regulatory practices in their own interest. Contract Research Organisations, with relevant, new, epistemic skills and capacities, are both manifestations of the changes in commercial research cultures, as well as the vehicles to
Snooks, Helen; Hutchings, Hayley; Seagrove, Anne; Stewart-Brown, Sarah; Williams, John; Russell, Ian
Recent developments aiming to standardise and streamline processes of gaining the necessary approvals to carry out research in the National Health Service (NHS) in the United Kingdom (UK), have resulted in lengthy and costly delays. The national UK governmental Department of Health's Research Governance Framework (RGF) for Health and Social Care requires that appropriate checks be conducted before research involving human participants, their organs, tissues or data can commence in the NHS. As a result, medical research has been subjected to increased regulation and governance, with the requirement for approvals from numerous regulatory and monitoring bodies. In addition, the processes and outcomes of the attribution of costs in NHS research have caused additional difficulties for researchers. The purpose of this paper is to illustrate, through three trial case studies, the difficulties encountered during the set-up and recruitment phases of these trials, related to gaining the necessary ethical and governance approvals and applying for NHS costs to undertake and deliver the research. Empirical evidence about delays and difficulties related to regulation and governance of medical research was gathered during the period 2009-2010 from three UK randomised controlled trials with sites in England, Wales and Scotland (1. SAFER 2- an emergency care based trial of a protocol for paramedics to refer patients directly to community based falls services; 2. COnStRUCT- a trial of two drugs for acute ulcerative colitis; and 3. Family Links - a trial of a public health intervention, a 10 week community based parenting programme). Findings and recommendations were reported in response to a call for evidence from The Academy of Medical Sciences regarding difficulties encountered in conducting medical research arising from R&D governance and regulation, to inform national policy. Difficulties and delays in navigating and gaining the appropriate approvals and NHS costs required to
Jens Mohrenweiser; Paul Marginson; Uschi Backes-Gellner
This paper analyses events that trigger the establishment of a works council and the actor or agent who triggers it. The paper extends previous research in two dimensions. First, we examine specific events that motivate workers to establish a works council, such as a change of owner, founding a spin-off, a firm-acquisition or a radical restructuring. These events express risk protection as workers’ primary motivation for establishing a works council. Second, we analyse the actor or agent who ...
Pasquali, Sara K.; Burstein, Danielle S.; Benjamin, Daniel K.; Smith, P. Brian; Li, Jennifer S.
Background Recent studies have examined the globalization of clinical research. These studies focused on adult trials, and the globalization of pediatric research has not been examined to date. We evaluated the setting of published studies conducted under the US Pediatric Exclusivity Program, which provides economic incentives to pharmaceutical companies to conduct drug studies in children. Methods Published studies containing the main results of trials conducted from 1998–2007 under the Pediatric Exclusivity Provision were included. Data were extracted from each study and described, including the therapeutic area of drug studied, number of patients enrolled, number of sites, and location where the study was conducted, if reported. Results Overall, 174 trials were included (sample size 8–27,065 patients); 9% did not report any information regarding the location or number of sites where the study was conducted. Of those that did report this information, 65% were conducted in at least one country outside the US, and 11% did not have any sites in the US. Fifty-four different countries were represented and 38% of trials enrolled patients in at least one site located in a developing/transition country, including more than one third of infectious disease, cardiovascular, and allergy/immunology trials. Conclusions The majority of published pediatric trials conducted under the Pediatric Exclusivity Provision included sites outside of the US, and over a third of trials enrolled patients in developing/transition countries. While there are many potential benefits to the globalization of pediatric research, this trend also raises certain scientific and ethical concerns which require further evaluation. PMID:20732941
Mathie, Robert T; Hacke, Daniela; Clausen, Jürgen
Systematic review of the research evidence in veterinary homeopathy has never previously been carried out. This paper presents the search methods, together with categorised lists of retrieved records, that enable us to identify the literature that is acceptable for future systematic review of randomised controlled trials (RCTs) in veterinary homeopathy. All randomised and controlled trials of homeopathic intervention (prophylaxis and/or treatment of disease, in any species except man) were appraised according to pre-specified criteria. The following databases were systematically searched from their inception up to and including March 2011: AMED; Carstens-Stiftung Homeopathic Veterinary Clinical Research (HomVetCR) database; CINAHL; Cochrane Central Register of Controlled Trials; Embase; Hom-Inform; LILACS; PubMed; Science Citation Index; Scopus. One hundred and fifty records were retrieved; 38 satisfied the acceptance criteria (substantive report of a clinical treatment or prophylaxis trial in veterinary homeopathic medicine randomised and controlled and published in a peer-reviewed journal), and were thus eligible for future planned systematic review. Approximately half of the rejected records were theses. Seven species and 27 different species-specific medical conditions were represented in the 38 papers. Similar numbers of papers reported trials of treatment and prophylaxis (n=21 and n=17 respectively) and were controlled against placebo or other than placebo (n=18, n=20 respectively). Most research focused on non-individualised homeopathy (n=35 papers) compared with individualised homeopathy (n=3). The results provide a complete and clarified view of the RCT literature in veterinary homeopathy. We will systematically review the 38 substantive peer-reviewed journal articles under the main headings: treatment trials; prophylaxis trials. Copyright © 2012 The Faculty of Homeopathy. Published by Elsevier Ltd. All rights reserved.
Archer, Stephanie Wilson; Carlo, Waldemar A.; Truog, William E.; Stevenson, David K.; Van Meurs, Krisa P.; Sánchez, Pablo J.; Das, Abhik; Devaskar, Uday; Nelin, Leif D.; Petrie Huitema, Carolyn M.; Crawford, Margaret M.; Higgins, Rosemary D.
Unpublished results can bias biomedical literature, favoring positive over negative findings, primary over secondary analyses, and can lead to duplicate studies that unnecessarily endanger subjects and waste resources. The Neonatal Research Network’s (NRN) publication policies for approving, reviewing, and tracking abstracts and papers work to combat these problems. In 2003, the NRN restricted investigators with unfinished manuscripts from proposing new ones and in 2010, urged authors to complete long-outstanding manuscripts. Data from 1991 to 2015 were analyzed to determine effectiveness of these policy changes. The NRN has achieved an overall publication rate of 78% for abstracts. For 1990–2002, of 137 abstracts presented, 43 (31%) were published within 2 years; for 2003–2009, after the manuscript completion policy was instituted, of 140 abstracts presented, 68 (49%) were published within 2 years. Following the effort in 2010, the rate increased to 64%. The NRN surpassed reported rates by developing a comprehensive process, holding investigators accountable and tracking abstracts from presentation to publication. PMID:27423510
Background Research into the methods used in the design, conduct, analysis, and reporting of clinical trials is essential to ensure that effective methods are available and that clinical decisions made using results from trials are based on the best available evidence, which is reliable and robust. Methods An on-line Delphi survey of 48 UK Clinical Research Collaboration registered Clinical Trials Units (CTUs) was undertaken. During round one, CTU Directors were asked to identify important topics that require methodological research. During round two, their opinion about the level of importance of each topic was recorded, and during round three, they were asked to review the group’s average opinion and revise their previous opinion if appropriate. Direct reminders were sent to maximise the number of responses at each round. Results are summarised using descriptive methods. Results Forty one (85%) CTU Directors responded to at least one round of the Delphi process: 25 (52%) responded in round one, 32 (67%) responded in round two, 24 (50%) responded in round three. There were only 12 (25%) who responded to all three rounds and 18 (38%) who responded to both rounds two and three. Consensus was achieved amongst CTU Directors that the top three priorities for trials methodological research were ‘Research into methods to boost recruitment in trials’ (considered the highest priority), ‘Methods to minimise attrition’ and ‘Choosing appropriate outcomes to measure’. Fifty other topics were included in the list of priorities and consensus was reached that two topics, ‘Radiotherapy study designs’ and ‘Low carbon trials’, were not priorities. Conclusions This priority setting exercise has identified the research topics felt to be most important to the key stakeholder group of Directors of UKCRC registered CTUs. The use of robust methodology to identify these priorities will help ensure that this work informs the trials methodological research agenda, with
Full Text Available ... take part in a clinical trial. When researchers think that a trial's potential risks are greater than ... care costs for clinical trials. If you're thinking about taking part in a clinical trial, find ...
REFLEXIONES SOBRE SABER , REVISTA CIENTÍFICA DEL CONSEJO DE INVESTIGACION DE LA UNIVERSIDAD DE ORIENTE I REFLECTIONS ON SABER , SCIENTIFIC JOURNAL OF THE RESEARCH COUNCIL OF THE UNIVERSIDAD DE ORIENTE
GERÓNIMO OJEDA CRESPO
Full Text Available Presents a brief account of the beginnings of the Universidad de Oriente, higher education institution seated in the eastern territory of Venezuela; as well as also related to attempts to establish a “editorial policy” in the different campuses university, periodical publications of scientific character. In describing the path of SABER periodical publication, multidisciplinary, financed and edited by the Research Council , presents a sequence of events that have marked both their presence and their contribution to the university community. Finally we suggest a number of actions to continue the important work of SABER as scientific journal of the Universidad de Oriente.
Elliott, Daisy; Husbands, Samantha; Hamdy, Freddie C; Holmberg, Lars; Donovan, Jenny L
The importance of evidence from randomised trials is now widely recognised, although recruitment is often difficult. Qualitative research has shown promise in identifying the key barriers to recruitment, and interventions have been developed to reduce organisational difficulties and support clinicians undertaking recruitment. This article provides an introduction to qualitative research techniques and explains how this approach can be used to understand-and subsequently improve-recruitment and informed consent within a range of clinical trials. A literature search was performed using Medline, Embase, and CINAHL. All studies with qualitative research methods that focused on the recruitment activity of clinicians were included in the review. The majority of studies reported that organisational difficulties and lack of time for clinical staff were key barriers to recruitment. However, a synthesis of qualitative studies highlighted the intellectual and emotional challenges that arise when combining research with clinical roles, particularly in relation to equipoise and patient eligibility. To support recruiters to become more comfortable with the design and principles of randomised controlled trials, interventions have been developed, including the QuinteT Recruitment Intervention, which comprises in-depth investigation of recruitment obstacles in real time, followed by implementation of tailored strategies to address these challenges as the trial proceeds. Qualitative research can provide important insights into the complexities of recruitment to trials and inform the development of interventions, and provide support and training initiatives as required. Investigators should consider implementing such methods in trials expected to be challenging or recruiting below target. Qualitative research is a term used to describe a range of methods that can be implemented to understand participants' perspectives and behaviours. Data are gathered from interviews, focus groups
State Employees Statewide Suicide Prevention Council DHSS State of Alaska Home Divisions and Agencies National Suicide Prevention Lifeline Alaska Community Mental Health Centers National Survivors of Suicide Meetings Presentations 2010 Alaska Statewide Suicide Prevention Summit: Mending the Net Connect with us on
Elections to fill all seats in the Staff Council are being organized this month. The voting takes place from the 31st of October to the 14th of November, at noon. As you may have noted when reading Echo, many issues concerning our employment conditions are on the agenda of the coming months and will keep the next Staff Council very busy. So, make your voice heard and take part in the elections for a new Staff Council. By doing so, you will be encouraging the men and women who will be representing you over the next two years and they will doubtless appreciate your gratitude. Every member of the Staff Association will have received an email containing a link to the webpage which will allow voting. If you are a member of the Staff Association and you did not receive such an email, please contact the Staff Association secretariat (email@example.com). Do not forget to vote * * * * * * * Vote Make your voice heard and be many to elect the new Staff Council. More details on the election...
Council of Organizations Serving the Deaf, Washington, DC.
Information is provided on the purposes, goals, functions, membership, board of directors, calendar of events, publications, and names and addresses of the officers or executive committees of 19 national organizations serving the deaf. Organizations included are the Council of Organizations Serving the Deaf, Alexander Graham Bell Association for…
This week’s Council meeting was dominated by discussions about the long-term, sustainable future of CERN. Key points are progress on the Medium-Term Plan, the successful LHC restart, and enlargement. The budget proposed by management for 2016 was well received, as were the measures to mitigate against the recent change in exchange rates. These items will be put to the vote in September. Discussions on CERN staff employment conditions were conducted in a constructive atmosphere this week, and will continue in future Council meetings. The Council also clearly voiced its congratulations for the smooth and successful start of LHC run 2, coming on top of a clear run of spectacular scientific and technological successes over recent years. In the current climate of austerity, these developments are a strong endorsement from the Council. Nevertheless, it would be disingenuous of me to pretend that everything is rosy. There has been an air of unease at CERN over recent months, which was v...
Research Article (New England Journal of Medicine) A trial of a 7-valent pneumococcal conjugate vaccine in HIV-infected adults. Neil French, Stephen B. Gordon, Thandie Mwalukomo, Sarah A. White, Gershom Mwafulirwa, Herbert Longwe, Martin Mwaiponya, Eduard E. Zijlstra, Malcolm E. Molyneux, Charles F. Gilks ...
Rodrigues, H. C. M. L.; Deprest, J.; v. d. Berg, P. P.
Objective In this article, we reflect on whether randomized controlled trials (RCTs) are adequate for the clinical evaluation of maternal-fetal surgery for congenital diaphragmatic hernia (CDH), focusing on the role of patients' preferences in the setting up of research protocols, on the requirement
Kiluk, Brian D; Carroll, Kathleen M; Duhig, Amy; Falk, Daniel E; Kampman, Kyle; Lai, Shengan; Litten, Raye Z; McCann, David J; Montoya, Ivan D; Preston, Kenzie L; Skolnick, Phil; Weisner, Constance; Woody, George; Chandler, Redonna; Detke, Michael J; Dunn, Kelly; Dworkin, Robert H; Fertig, Joanne; Gewandter, Jennifer; Moeller, F Gerard; Ramey, Tatiana; Ryan, Megan; Silverman, Kenneth; Strain, Eric C
The development and approval of an efficacious pharmacotherapy for stimulant use disorders has been limited by the lack of a meaningful indicator of treatment success, other than sustained abstinence. In March, 2015, a meeting sponsored by Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks (ACTTION) was convened to discuss the current state of the evidence regarding meaningful outcome measures in clinical trials for stimulant use disorders. Attendees included members of academia, funding and regulatory agencies, pharmaceutical companies, and healthcare organizations. The goal was to establish a research agenda for the development of a meaningful outcome measure that may be used as an endpoint in clinical trials for stimulant use disorders. Based on guidelines for the selection of clinical trial endpoints, the lessons learned from prior addiction clinical trials, and the process that led to identification of a meaningful indicator of treatment success for alcohol use disorders, several recommendations for future research were generated. These include a focus on the validation of patient reported outcome measures of functioning, the exploration of patterns of stimulant abstinence that may be associated with physical and/or psychosocial benefits, the role of urine testing for validating self-reported measures of stimulant abstinence, and the operational definitions for reduction-based measures in terms of frequency rather than quantity of stimulant use. These recommendations may be useful for secondary analyses of clinical trial data, and in the design of future clinical trials that may help establish a meaningful indicator of treatment success. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.
... DEPARTMENT OF COMMERCE International Trade Administration Manufacturing Council AGENCY... candidate's proven experience in promoting, developing and marketing programs in support of manufacturing... participating in Council meetings and events are responsible for their travel, living and other personal...
... DEPARTMENT OF COMMERCE International Trade Administration Manufacturing Council AGENCY... experience in promoting, developing and marketing programs in support of manufacturing industries, in job... Council meetings and events are responsible for their travel, living and other personal expenses. Meetings...
This article is part of a series of papers examining ethical issues in cluster randomized trials (CRTs) in health research. In the introductory paper in this series, Weijer and colleagues set out six areas of inquiry that must be addressed if the cluster trial is to be set on a firm ethical foundation. This paper addresses the third of the questions posed, namely, does clinical equipoise apply to CRTs in health research? The ethical principle of beneficence is the moral obligation not to harm needlessly and, when possible, to promote the welfare of research subjects. Two related ethical problems have been discussed in the CRT literature. First, are control groups that receive only usual care unduly disadvantaged? Second, when accumulating data suggests the superiority of one intervention in a trial, is there an ethical obligation to act? In individually randomized trials involving patients, similar questions are addressed by the concept of clinical equipoise, that is, the ethical requirement that, at the start of a trial, there be a state of honest, professional disagreement in the community of expert practitioners as to the preferred treatment. Since CRTs may not involve physician-researchers and patient-subjects, the applicability of clinical equipoise to CRTs is uncertain. Here we argue that clinical equipoise may be usefully grounded in a trust relationship between the state and research subjects, and, as a result, clinical equipoise is applicable to CRTs. Clinical equipoise is used to argue that control groups receiving only usual care are not disadvantaged so long as the evidence supporting the experimental and control interventions is such that experts would disagree as to which is preferred. Further, while data accumulating during the course of a CRT may favor one intervention over another, clinical equipoise supports continuing the trial until the results are likely to be broadly convincing, often coinciding with the planned completion of the trial
Ulbrich-Zürni, Susanne; Teut, Michael; Roll, Stephanie; Mathie, Robert T
The randomised controlled trial (RCT) is considered the 'gold standard' for establishing treatment efficacy or effectiveness of an intervention, but its data do not infer response in an individual patient. Individualised clinical care, a fundamental principle in complementary and alternative medicine (CAM), including homeopathy, seems well disposed in principle to being researched by single-patient (N-of-1) study design. Guidelines for reporting N-of-1 trials have recently been developed. To overview the current status in the literature of the N-of-1 method and its application in medicine, including CAM. To consider whether the N-of-1 trial design offers an opportunity for novel research in homeopathy. N-OF-1 TRIAL DESIGN: The N-of-1 trial applies the principles of the conventional crossover, blinded, RCT design. The treatment under study and the comparator are repeated in a randomised order, and with suitable washout time, over a defined period. N-of-1 design is constrained for use in chronic stable conditions, and for interventions that have quick onset and cessation of effect, with modest or negligible carryover. Outcome data can be aggregated and interpreted for the individual subject; they can also be pooled with data from several similar N-of-1 trials, enabling more generalisable conclusions. THE N-OF-1 TRIAL IN CAM: The typical individualisation of patient care can be accommodated in N-of-1 study design if the patient and the specific therapeutic intervention are selected within the constraints of the method. Application of the N-of-1 method in CAM has been advocated but has been mainly limited, in practice, to a small number of studies in herbal and traditional Chinese medicine. THE N-OF-1 TRIAL IN HOMEOPATHY: Individualised homeopathy can be accommodated for investigation within the same methodological constraints; less in-depth homeopathic approaches to prescribing are also amendable to investigation using the N-of-1 method. No such studies
Harling, O.K.; Bernard, J.A.; Yam, Chun-Shan
The Massachusetts Institute of Technology (MIT), the New England Medical Center (NEMC), and Boston University Medical Center (BUMC) initiated a phase-1 trial of boron neutron capture therapy (BNCT) on September 6, 1994, at the 5-MW(thermal) MIT research reactor (MITR). A novel form of experimental cancer therapy, BNCT is being developed for certain types of highly malignant brain tumors such as glioblastoma and melanoma. The results of the phase-1 trials on patients with tumors in the legs or feet are described
Albright, Karen; Gechter, Katherine; Kempe, Allison
With increased attention to the importance of translating research to clinical practice and policy, recent years have seen a proliferation of particular types of research, including pragmatic trials and dissemination and implementation research. Such research seeks to understand how and why interventions function in real-world settings, as opposed to highly controlled settings involving conditions not likely to be repeated outside the research study. Because understanding the context in which interventions are implemented is imperative for effective pragmatic trials and dissemination and implementation research, the use of mixed methods is critical to understanding trial results and the success or failure of implementation efforts. This article discusses a number of dimensions of mixed methods research, utilizing at least one qualitative method and at least one quantitative method, that may be helpful when designing projects or preparing grant proposals. Although the strengths and emphases of qualitative and quantitative approaches differ substantially, methods may be combined in a variety of ways to achieve a deeper level of understanding than can be achieved by one method alone. However, researchers must understand when and how to integrate the data as well as the appropriate order, priority, and purpose of each method. The ability to demonstrate an understanding of the rationale for and benefits of mixed methods research is increasingly important in today's competitive funding environment, and many funding agencies now expect applicants to include mixed methods in proposals. The increasing demand for mixed methods research necessitates broader methodological training and deepened collaboration between medical, clinical, and social scientists. Although a number of challenges to conducting and disseminating mixed methods research remain, the potential for insight generated by such work is substantial. Copyright © 2013 Academic Pediatric Association. Published by
Pediatric Clinical Trials Conducted in South Korea from 2006 to 2015: An Analysis of the South Korean Clinical Research Information Service, US ClinicalTrials.gov and European Clinical Trials Registries.
Choi, Sheung-Nyoung; Lee, Ji-Hyun; Song, In-Kyung; Kim, Eun-Hee; Kim, Jin-Tae; Kim, Hee-Soo
The status of pediatric clinical trials performed in South Korea in the last decade, including clinical trials of drugs with unapproved indications for children, has not been previously examined. The aim was to provide information regarding the current state of pediatric clinical trials and create a basis for future trials performed in South Korea by reviewing three databases of clinical trials registrations. We searched for pediatric clinical studies (participants South Korea between 2006 and 2015 registered on the Clinical Research Information Service (CRIS), ClinicalTrials.gov, and the European Clinical Trials Registry (EuCTR). Additionally, we reviewed whether unapproved indications were involved in each trial by comparing the trials with a list of authorized trials provided by the Ministry of Food and Drug Safety (MFDS). The primary and secondary outcomes were to determine the change in number of pediatric clinical trials with unapproved indications over time and to assess the status of unauthorized pediatric clinical trials from the MFDS and the publication of articles after these clinical trials, respectively. We identified 342 clinical studies registered in the CRIS (n = 81), ClinicalTrials.gov (n = 225), and EuCTR (n = 36), of which 306 were reviewed after excluding duplicate registrations. Among them, 181 studies were interventional trials dealing with drugs and biological agents, of which 129 (71.3%) involved unapproved drugs. Of these 129 trials, 107 (82.9%) were authorized by the MFDS. Pediatric clinical trials in South Korea aiming to establish the safety and efficacy of drugs in children are increasing; however, non-MFDS-authorized studies remain an issue.
Bobb, Morgan R.; Van Heukelom, Paul G.; Faine, Brett A.; Ahmed, Azeemuddin; Messerly, Jeffrey T.; Bell, Gregory; Harland, Karisa K.; Simon, Christian; Mohr, Nicholas M.
Objective Telemedicine networks are beginning to provide an avenue for conducting emergency medicine research, but using telemedicine to recruit participants for clinical trials has not been validated. The goal of this consent study is to determine whether patient comprehension of telemedicine-enabled research informed consent is non-inferior to standard face-to-face research informed consent. Methods A prospective, open-label randomized controlled trial was performed in a 60,000-visit Midwestern academic Emergency Department (ED) to test whether telemedicine-enabled research informed consent provided non-inferior comprehension compared with standard consent. This study was conducted as part of a parent clinical trial evaluating the effectiveness of oral chlorhexidine gluconate 0.12% in preventing hospital-acquired pneumonia among adult ED patients with expected hospital admission. Prior to being recruited into the study, potential participants were randomized in a 1:1 allocation ratio to consent by telemedicine versus standard face-to-face consent. Telemedicine connectivity was provided using a commercially available interface (REACH platform, Vidyo Inc., Hackensack, NJ) to an emergency physician located in another part of the ED. Comprehension of research consent (primary outcome) was measured using the modified Quality of Informed Consent (QuIC) instrument, a validated tool for measuring research informed consent comprehension. Parent trial accrual rate and qualitative survey data were secondary outcomes. Results One-hundred thirty-one patients were randomized (n = 64, telemedicine), and 101 QuIC surveys were completed. Comprehension of research informed consent using telemedicine was not inferior to face-to-face consent (QuIC scores 74.4 ± 8.1 vs. 74.4 ± 6.9 on a 100-point scale, p = 0.999). Subjective understanding of consent (p=0.194) and parent trial study accrual rates (56% vs. 69%, p = 0.142) were similar. Conclusion Telemedicine is non-inferior to face
Atkinson, Nancy L; Massett, Holly A; Mylks, Christy; McCormack, Lauren A; Kish-Doto, Julia; Hesse, Bradford W; Wang, Min Qi
Informatics applications have the potential to improve participation in clinical trials, but their design must be based on user-centered research. This research used a fully counterbalanced experimental design to investigate the effect of changes made to the original version of a website, http://BreastCancerTrials.org/, and confirm that the revised version addressed and reinforced patients' needs and expectations. Participants included women who had received a breast cancer diagnosis within the last 5 years (N=77). They were randomized into two groups: one group used and reviewed the original version first followed by the redesigned version, and the other group used and reviewed them in reverse order. The study used both quantitative and qualitative measures. During use, participants' click paths and general reactions were observed. After use, participants were asked to answer survey items and open-ended questions to indicate their reactions and which version they preferred and met their needs and expectations better. Overall, the revised version of the site was preferred and perceived to be clearer, easier to navigate, more trustworthy and credible, and more private and safe overall. However, users who viewed the original version last had similar attitudes toward both versions. By applying research findings to the redesign of a website for clinical trial searching, it was possible to re-engineer the interface to better support patients' decisions to participate in clinical trials. The mechanisms of action in this case appeared to revolve around creating an environment that supported a sense of personal control and decisional autonomy.
Full Text Available ... Clinical Trials About Clinical Trials Clinical trials are research studies that explore whether a medical strategy, treatment, ... required to have an IRB. Office for Human Research Protections The U.S. Department of Health and Human ...
Full Text Available ... or device is safe and effective for humans. What Are Clinical Trials? Clinical trials are research studies ... parents, clinicians, researchers, children, and the general public. What to Expect During a clinical trial, doctors, nurses, ...
Full Text Available The project Trials in the Late Roman Republic II (TLRR II aims at collecting, organizing, and analyzing information about Roman legal cases in an XML database. M. Alexander published the book “Trials in the Late Roman Republic, 149 BC to 50 BC” (TLRR I in 1990, and initiated the current project that will make Roman republican trials easily accessible with modern technology. For each case a short description is provided, a clear distinction between assumptions and facts is made, and an updated bibliography can be found at the end of each entry. The open access database can serve both as a reference work and as a starting point for further research in Roman Republican history. It could be a connecting link within the developing digital infrastructure for that era.
This initiative seeks to strengthen the capacities of science granting councils in East Africa and other selected sub-Saharan African countries. The goal is to contribute to economic and social development in the region through research and evidence-based policies. About the science granting councils initiative The Science ...
..., spawning areas and/or dedicated habitat research areas. Prior to a lunch break, the Council will receive an... plaice rebuilding plans, and small-mesh accountability measures (AMs) for the Georges Bank yellowtail... will be addressed. After a lunch break, the Scallop Committee will update the Council on the...
Ferriere, Michael; Van Ness, Brian
The National Cancer Institute (NCI)-funded cooperative group cancer clinical trial system develops experimental therapies and often collects samples from patients for correlative research. The cooperative group bank (CGB) system maintains biobanks with a current policy not to return research results to individuals. An online survey was created, and 10 directors of CGBs completed the surveys asking about understanding and attitudes in changing policies to consider return of incidental findings (IFs) and individual research results (IRRs) of health significance. The potential impact of the 10 consensus recommendations of Wolf et al. presented in this issue are examined. Reidentification of samples is often not problematic; however, changes to the current banking and clinical trial systems would require significant effort to fulfill an obligation of recontact of subjects. Additional resources, as well as a national advisory board would be required to standardize implementation.
Essack, Zaynab; Wassenaar, Douglas R
HIV prevention trials provide a prevention package to participants to help prevent HIV acquisition. As new prevention methods are proven effective, this raises ethical and scientific design complexities regarding the prevention package or standard of prevention. Given its high HIV incidence and prevalence, South Africa has become a hub for HIV prevention research. For this reason, it is critical to study the implementation of relevant ethical-legal frameworks for such research in South Africa. This qualitative study used in-depth interviews to explore the practices and perspectives of eight members of South African research ethics committees (RECs) who have reviewed protocols for HIV vaccine trials. Their practices and perspectives are compared with ethics guideline requirements for standards of prevention.
Rapkin, Bruce D; Weiss, Elisa; Lounsbury, David; Michel, Tamara; Gordon, Alexis; Erb-Downward, Jennifer; Sabino-Laughlin, Eilleen; Carpenter, Alison; Schwartz, Carolyn E; Bulone, Linda; Kemeny, Margaret
Reduction of cancer-related disparities requires strategies that link medically underserved communities to preventive care. In this community-based participatory research project, a public library system brought together stakeholders to plan and undertake programs to address cancer screening and risk behavior. This study was implemented over 48 months in 20 large urban neighborhoods, selected to reach diverse communities disconnected from care. In each neighborhood, Cancer Action Councils were organized to conduct a comprehensive dynamic trial, an iterative process of program planning, implementation and evaluation. This process was phased into neighborhoods in random, stepped-wedge sequence. Population-level outcomes included self-reported screening adherence and smoking cessation, based on street intercept interviews. Event-history regressions (n = 9374) demonstrated that adherence outcomes were associated with program implementation, as were mediators such as awareness of screening programs and cancer information seeking. Findings varied by ethnicity, and were strongest among respondents born outside the U.S. or least engaged in care. This intervention impacted health behavior in diverse, underserved and vulnerable neighborhoods. It has been sustained as a routine library system program for several years after conclusion of grant support. In sum, participatory research with the public library system offers a flexible, scalable approach to reduce cancer health disparities. © Society for Community Research and Action 2017.
Full Text Available The paper deals with the structure, mechanisms, practices and perspectives of the Human Rights Council, the UN body that, at universal level is the most important body in this area. Introductory section provides for a brief overview of the origins of human rights and the work of the Commission on Human Rights, in whose jurisdiction were questions of human rights before the establishment of the Council. After the introductory section the author gives an analysis of the structure, objectives, mandate and main procedures for the protection of human rights within the united Nations. In the final section the authorpoints out the advantages of this authority and criticism addressed to it, with emphasis on the possibility and the need for its reform.
Gewandter, Jennifer S; Dworkin, Robert H; Turk, Dennis C; Farrar, John T; Fillingim, Roger B; Gilron, Ian; Markman, John D; Oaklander, Anne Louise; Polydefkis, Michael J; Raja, Srinivasa N; Robinson, James P; Woolf, Clifford J; Ziegler, Dan; Ashburn, Michael A; Burke, Laurie B; Cowan, Penney; George, Steven Z; Goli, Veeraindar; Graff, Ole X; Iyengar, Smriti; Jay, Gary W; Katz, Joel; Kehlet, Henrik; Kitt, Rachel A; Kopecky, Ernest A; Malamut, Richard; McDermott, Michael P; Palmer, Pamela; Rappaport, Bob A; Rauschkolb, Christine; Steigerwald, Ilona; Tobias, Jeffrey; Walco, Gary A
Although certain risk factors can identify individuals who are most likely to develop chronic pain, few interventions to prevent chronic pain have been identified. To facilitate the identification of preventive interventions, an IMMPACT meeting was convened to discuss research design considerations for clinical trials investigating the prevention of chronic pain. We present general design considerations for prevention trials in populations that are at relatively high risk for developing chronic pain. Specific design considerations included subject identification, timing and duration of treatment, outcomes, timing of assessment, and adjusting for risk factors in the analyses. We provide a detailed examination of 4 models of chronic pain prevention (ie, chronic postsurgical pain, postherpetic neuralgia, chronic low back pain, and painful chemotherapy-induced peripheral neuropathy). The issues discussed can, in many instances, be extrapolated to other chronic pain conditions. These examples were selected because they are representative models of primary and secondary prevention, reflect persistent pain resulting from multiple insults (ie, surgery, viral infection, injury, and toxic or noxious element exposure), and are chronically painful conditions that are treated with a range of interventions. Improvements in the design of chronic pain prevention trials could improve assay sensitivity and thus accelerate the identification of efficacious interventions. Such interventions would have the potential to reduce the prevalence of chronic pain in the population. Additionally, standardization of outcomes in prevention clinical trials will facilitate meta-analyses and systematic reviews and improve detection of preventive strategies emerging from clinical trials.
Perfil dos pesquisadores com bolsa de produtividade em pesquisa do CNPq da área de saúde coletiva A profile of researchers in public health with productivity grants from the Brazilian National Research Council (CNPq
Rita Barradas Barata
Full Text Available O artigo analisa, com base nas informações do currículo Lattes, o perfil dos pesquisadores com bolsa de produtividade em pesquisa do CNPq na área de Saúde Coletiva. A análise levou em conta a formação graduada e pós-graduada, área de atuação, produção e divulgação científica. As comparações são feitas entre as classes de pesquisadores e com dados do diretório de grupos de pesquisa. A maioria dos pesquisadores (70% são formados em Ciências da Saúde, principalmente em Medicina, ou em Ciências Humanas (18%, principalmente Sociologia. Sessenta por cento fizeram mestrado e doutorado em Saúde Coletiva, mas há entre 20 e 30% de pesquisadores, dependendo da classe, sem formação específica na área. A maioria atua em Epidemiologia. A produção científica, expressa em produtos bibliográficos, varia de 10,56 produtos/ano de obtenção do doutorado para os pesquisadores 2C a 6,60 produtos/ano para os pesquisadores 1A. Para artigos completos publicados em periódicos os valores são 3,56 e 2,87, respectivamente. A produção é divulgada principalmente em periódicos A internacional e, A e B nacional. Os periódicos que concentram a publicação são Cadernos de Saúde Pública e Revista de Saúde Pública.Based on information provided by the Lattes curriculum, this study analyzes the profile of researchers in public health with productivity grants from the Brazilian National Research Council (CNPq. The analysis considered the researcher’s undergraduate and graduate degrees, field of expertise, scientific output, and publications. The article discusses comparisons between different categories of researchers and data provided by the CNPq Research Group Directory. Most of the researchers (70% received their undergraduate degrees either in health sciences, mainly medicine, or the humanities (18%, mainly sociology. 60% have Master’s or PhDs in collective health, but some 20 to 30% of researchers, depending on the category
Council members present at the May 24, 1981, meeting were Keiiti Aki, Steven Burges (for Jim Wallis), Peter S. Eagleson, E. R. Engdahl, Charles E. Helsley, James R. Heirtzler, Carl Kisslinger, Leslie H. Meredith, Chris N. K. Mooers, Norman F. Ness, Marcia M. Neugebauer, James J. O'Brien, Richard Rapp, Carl Sagan, James C. Savage, Joseph V. Smith, Fred Spilhaus, Donald L. Turcotte, James A. Van Allen, J. Tuzo Wilson, and Jay Winston (for Elmar R. Reiter until his arrival at 6:50 P.M.). David Strangway, representing the Canadian Geophysical Union, and Peter Steinhauser, representing the European Geophysical Society, were special observers at the meeting. Council meetings are open, and a number of section secretaries, committee chairmen, journal editors, and other members attended. The following major actions were adopted by the Council:The experiment of publishing oceanography and lower-atmosphere papers in JGR Green issues alternate to those containing upper-atmosphere papers will be continued through 1982. From preliminary indications the experiment seems to be working, but a full year of data, including a renewal cycle, is needed to assess the success of the experiment. Final decision will be made prior to the 1983 dues notices.
One year ago, the Staff Association, together with the CERN-ESO Pensioners' Association, organized a staff meeting in front of this building to express our concern about certain actions of this Committee. Today we deem it necessary to come before you and convey in person, dear delegates, the concerns and worries of the staff. Indeed, the last 18 months we have observed a tendency of Council to take matters, in particular in the field of pensions, into its own hands, bypassing established governance structures, which Council has itself put into place. As a result, the Director General was prevented from playing his essential role of intermediary between staff and Council, an essential element of the established social dialogue. The creation of CERN in 1954 was very much based on the willingness of many countries of the old Continent to share resources to create a joint fundamental physics laboratory. The emphasis was on sharing resources for the common good to allow European scientists to engage in...
Elections to fill all seats in the Staff Council are being organized this month. The voting takes place from the 28 of October to the 11th of November, at noon. As you may have noted when reading Echo, many issues concerning our employment conditions are on the agenda of the coming months, and in particular the Five-yearly-Review 2015, subject of the questionnaire that you probably recently filled out. All this will keep the next Staff Council very busy indeed. So, make your voice heard and take part in the elections for a new Staff Council. By doing so, you will be encouraging the men and women who will be representing you over the next two years and they will doubtless appreciate your gratitude. Every member of the Staff Association will have received an email containing a link to the webpage which will allow voting. If you are a member of the Staff Association and you did not receive such an email, please contact the Staff Association secretariat (firstname.lastname@example.org). Do not forget to v...
Alexandrova, Petya; Rasmussen, Anne; Toshkov, Dimiter
The existence of political responsiveness in multi-level systems like the EU remains an open question despite significant recent research on the topic. This article studies whether the European Council responds to the shifting policy priorities of European citizens. More specifically, it explores......, a detailed examination of the shifts in prioritisation of single issues over time reveals little evidence for dynamic issue responsiveness. Recently the European Council has paid more attention to the issues that the public considered the most pressing problems but the convergence could possibly be driven...
... 7 Agriculture 10 2010-01-01 2010-01-01 false Council. 1209.4 Section 1209.4 Agriculture Regulations of the Department of Agriculture (Continued) AGRICULTURAL MARKETING SERVICE (MARKETING AGREEMENTS... CONSUMER INFORMATION ORDER Mushroom Promotion, Research, and Consumer Information Order Definitions § 1209...
Sunstein, Cass R
Findings in behavioral science, including psychology, have influenced policies and reforms in many nations. Choice architecture can affect outcomes even if material incentives are not involved. In some contexts, default rules, simplification, and social norms have had even larger effects than significant economic incentives. Psychological research is helping to inform initiatives in savings, finance, highway safety, consumer protection, energy, climate change, obesity, education, poverty, development, crime, corruption, health, and the environment. No nation has yet created a council of psychological advisers, but the role of behavioral research in policy domains is likely to grow in the coming years, especially in light of the mounting interest in promoting ease and simplification ("navigability"); in increasing effectiveness, economic growth, and competitiveness; and in providing low-cost, choice-preserving approaches.
Whitesides, Louisa W; Baren, Jill M; Biros, Michelle H; Fleischman, Ross J; Govindarajan, Prasanthi R; Jones, Elizabeth B; Pancioli, Arthur M; Pentz, Rebecca D; Scicluna, Victoria M; Wright, David W; Dickert, Neal W
Evidence suggests that patients are generally accepting of their enrollment in trials for emergency care conducted under exception from informed consent. It is unknown whether individuals with more severe initial injuries or worse clinical outcomes have different perspectives. Determining whether these differences exist may help to structure post-enrollment interactions. Primary clinical data from the Progesterone for the Treatment of Traumatic Brain Injury trial were matched to interview data from the Patients' Experiences in Emergency Research-Progesterone for the Treatment of Traumatic Brain Injury study. Answers to three key questions from Patients' Experiences in Emergency Research-Progesterone for the Treatment of Traumatic Brain Injury study were analyzed in the context of enrolled patients' initial injury severity (initial Glasgow Coma Scale and Injury Severity Score) and principal clinical outcomes (Extended Glasgow Outcome Scale and Extended Glasgow Outcome Scale relative to initial injury severity). The three key questions from Patients' Experiences in Emergency Research-Progesterone for the Treatment of Traumatic Brain Injury study addressed participants' general attitude toward inclusion in the Progesterone for the Treatment of Traumatic Brain Injury trial (general trial inclusion), their specific attitude toward being included in Progesterone for the Treatment of Traumatic Brain Injury trial under the exception from informed consent (personal exception from informed consent enrollment), and their attitude toward the use of exception from informed consent in the Progesterone for the Treatment of Traumatic Brain Injury trial in general (general exception from informed consent enrollment). Qualitative analysis of interview transcripts was performed to provide contextualization and to determine the extent to which respondents framed their attitudes in terms of clinical experience. Clinical data from Progesterone for the Treatment of Traumatic Brain Injury
Smith, Orla M; McDonald, Ellen; Zytaruk, Nicole; Foster, Denise; Matte, Andrea; Clarke, France; Fleury, Suzie; Krause, Katie; McArdle, Tracey; Skrobik, Yoanna; Cook, Deborah J
Critically ill patients lack capacity for decisions about research participation. Consent to enrol these patients in studies is typically obtained from substitute decision-makers. To present strategies that may optimise the process of obtaining informed consent from substitute decision-makers for participation of critically ill patients in trials. We use examples from a randomised trial of heparin thromboprophylaxis in the intensive care unit (PROTECT, clinicaltrials.gov NCT00182143). 3764 patients were randomised, with an informed consent rate of 82%; 90% of consents were obtained from substitute decision-makers. North American PROTECT research coordinators attended three meetings to discuss enrolment: (1) Trial start-up (January 2006); (2) Near trial closure (January 2010); and (3) Post-publication (April 2011). Data were derived from slide presentations, field notes from break-out groups and plenary discussions, then analysed inductively. We derived three phases for the informed consent process: (1) Preparation for the Consent Encounter; (2) The Consent Encounter; and (3) Follow-up to the Consent Encounter. Specific strategies emerged for each phase: Phase 1 (four strategies); Phase 2 (six strategies); and Phase 3 (three strategies). We identified 13 strategies that may improve the process of obtaining informed consent from substitute decision-makers and be generalisable to other settings and studies. Copyright © 2013 The Authors. Published by Elsevier Ltd.. All rights reserved.
Full Text Available Abstract Background Action research (AR and randomized controlled trials (RCTs are usually considered to be theoretically and practically incompatible. However, we argue that their respective strengths and weaknesses can be complementary. We illustrate our argument from a recent study assessing the effect of telemonitoring on health-related quality of life, self-care, hospital use, costs and the experiences of patients, informal carers and health care professionals in two urban hospital services and one remote rural primary care service in New Zealand. Methods Data came from authors’ observations and field notes of discussions with three groups: the healthcare providers and healthcare consumers who participated in the research, and a group of 17 researchers and collaborators. The consumers had heart failure (Site A, urban, airways disease (Site B, urban, and diabetes (Site C, rural. The research ran from 2008 (project inception until 2012 (project close-off. Researchers came from a wide range of disciplines. Both RCT and AR methods were recognised from early in the process but often worked in parallel rather than together. In retrospect, we have mapped our observed research processes to the AR cycle characteristics (creation of communicative space, democracy and participation, iterative learning and improvement, emergence, and accommodation of different ways of knowing. Results We describe the context, conduct and outcomes of the telemonitoring trial, framing the overall process in the language of AR. Although not fully articulated at the time, AR processes made the RCT sensitive to important context, e.g. clinical processes. They resulted in substantive changes to the design and conduct of the RCT, and to interpretation and uptake of findings, e.g. a simpler technology procurement process emerged. Creating a communicative space enabled co-design between the researcher group and collaborators from the provider participant group, and a stronger
... Industry perspective on public clinical trial registries and results databases . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ...
Patrick, Kevin; Wolszon, Laura; Basen-Engquist, Karen M; Demark-Wahnefried, Wendy; Prokhorov, Alex V; Barrera, Stephanie; Baru, Chaitan; Farcas, Emilia; Krueger, Ingolf; Palmer, Doug; Raab, Fred; Rios, Phil; Ziftci, Celal; Peterson, Susan
ABSTRACT Improved approaches and methodologies are needed to conduct comparative effectiveness research (CER) in oncology. While cancer therapies continue to emerge at a rapid pace, the review, synthesis, and dissemination of evidence-based interventions across clinical trials lag in comparison. Rigorous and systematic testing of competing therapies has been clouded by age-old problems: poor patient adherence, inability to objectively measure the environmental influences on health, lack of kn...
Tondorf, Theresa; Kaufmann, Lisa-Katrin; Degel, Alexander; Locher, Cosima; Birkhäuer, Johanna; Gerger, Heike; Ehlert, Ulrike
Psychotherapy has been shown to be effective, but efforts to prove specific effects by placebo-controlled trials have been practically and conceptually hampered. We propose that adopting open/hidden designs from placebo research would offer a possible way to establish specificity in psychotherapy. Therefore, we tested the effects of providing opposing treatment rationales in an online expressive writing intervention on affect in healthy subjects. Results indicate that it was possible to conduct the expressive writing intervention both covertly and openly, but that participants in the hidden administration condition did not fully benefit from the otherwise effective expressive writing intervention in the long-run. Effect sizes between open and hidden administration groups were comparable to pre-post effect sizes of the intervention. While this finding is important for the understanding of psychotherapy's effects per se, it also proves that alternative research approaches to establish specificity are feasible and informative in psychotherapy research. Trial registration: German Clinical Trials Register DRKS00009428 PMID:29176768
Background Loneliness in older people is associated with poor health-related quality of life (HRQoL). We undertook a parallel-group randomised controlled trial to evaluate the effectiveness and cost-effectiveness of telephone befriending for the maintenance of HRQoL in older people. An internal pilot tested the feasibility of the trial and intervention. Methods Participants aged >74 years, with good cognitive function, living independently in one UK city were recruited through general practices and other sources, then randomised to: (1) 6 weeks of short one-to-one telephone calls, followed by 12 weeks of group telephone calls with up to six participants, led by a trained volunteer facilitator; or (2) a control group. The main trial required the recruitment of 248 participants in a 1-year accrual window, of whom 124 were to receive telephone befriending. The pilot specified three success criteria which had to be met in order to progress the main trial to completion: recruitment of 68 participants in 95 days; retention of 80% participants at 6 months; successful delivery of telephone befriending by local franchise of national charity. The primary clinical outcome was the Short Form (36) Health Instrument (SF-36) Mental Health (MH) dimension score collected by telephone 6 months following randomisation. Results We informed 9,579 older people about the study. Seventy consenting participants were randomised to the pilot in 95 days, with 56 (80%) providing valid primary outcome data (26 intervention, 30 control). Twenty-four participants randomly allocated to the research arm actually received telephone befriending due to poor recruitment and retention of volunteer facilitators. The trial was closed early as a result. The mean 6-month SF-36 MH scores were 78 (SD 18) and 71 (SD 21) for the intervention and control groups, respectively (mean difference, 7; 95% CI, -3 to 16). Conclusions Recruitment and retention of participants to a definitive trial with a
The internal matters of the council are reported followed by reports from the individual committees. These include committees of radiation hygiene, food irradiation, the disposal of radioactive waste and the classification of isotope laboratories, guide-lines for radiation protection in hospitals and clinics, isotope laboratories, legal liability for radiation accidents, nuclear heart stimulators, computer tomography, supplementary advice about nuclear energy, combustion furnace for radioactive waste, and experiments with radioactive materials on testees. Each report describes the setting up of the committee, the members, its function with a short description of the work completed in 1977. (Auth.)
Kidwell, Kelley M; Postow, Michael A; Panageas, Katherine S
Clinical trials investigating immune checkpoint inhibitors have led to the approval of anti-CTLA-4 (cytotoxic T-lymphocyte antigen-4), anti-PD-1 (programmed death-1), and anti-PD-L1 (PD-ligand 1) drugs by the FDA for numerous tumor types. In the treatment of metastatic melanoma, combinations of checkpoint inhibitors are more effective than single-agent inhibitors, but combination immunotherapy is associated with increased frequency and severity of toxicity. There are questions about the use of combination immunotherapy or single-agent anti-PD-1 as initial therapy and the number of doses of either approach required to sustain a response. In this article, we describe a novel use of sequential, multiple assignment, randomized trial (SMART) design to evaluate immune checkpoint inhibitors to find treatment regimens that adapt within an individual based on intermediate response and lead to the longest overall survival. We provide a hypothetical example SMART design for BRAF wild-type metastatic melanoma as a framework for investigating immunotherapy treatment regimens. We compare implementing a SMART design to implementing multiple traditional randomized clinical trials. We illustrate the benefits of a SMART over traditional trial designs and acknowledge the complexity of a SMART. SMART designs may be an optimal way to find treatment strategies that yield durable response, longer survival, and lower toxicity. Clin Cancer Res; 24(4); 730-6. ©2017 AACR . ©2017 American Association for Cancer Research.
Gale, C; Hyde, M J; Modi, N
Randomised controlled trials, a gold-standard approach to reduce uncertainties in clinical practice, are growing in cost and are often slow to recruit. We determined whether methodological approaches to facilitate large, efficient clinical trials were acceptable to UK research ethics committees (RECs). We developed a protocol in collaboration with parents, for a comparative-effectiveness, randomised controlled trial comparing two widely used blood transfusion practices in preterm infants. We incorporated four approaches to improve recruitment and efficiency: (i) point-of-care design using electronic patient records for patient identification, randomisation and data acquisition, (ii) short two-page information sheet; (iii) explicit mention of possible inclusion benefit; (iv) opt-out consent with enrolment as the default. With the support of the UK Health Research Authority, we submitted an identical protocol to 12 UK REC. RECs in the UK. Number of REC granting favourable opinions. The use of electronic patient records was acceptable to all RECs; one REC raised concerns about the short parent information sheet, 10 about inclusion benefit and 9 about opt-out consent. Following responses to queries, nine RECs granted a favourable final opinion and three rejected the application because they considered the opt-out consent process invalid. A majority of RECs in this study consider the use of electronic patient record data, short information sheets, opt-out consent and mention of possible inclusion benefit to be acceptable in neonatal comparative-effectiveness research. We identified a need for guidance for RECs in relation to opt-out consent processes. These methods provide opportunity to facilitate large randomised controlled trials. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.
Festinger, David S; Dugosh, Karen L; Croft, Jason R; Arabia, Patricia L; Marlowe, Douglas B
We examined the efficacy of including a research intermediary (RI) during the consent process in reducing participants' perceptions of coercion to enroll in a research study. Eighty-four drug court clients being recruited into an ongoing study were randomized to receive a standard informed consent process alone (standard condition) or with an RI (intermediary condition). Before obtaining consent, RIs met with clients individually to discuss remaining concerns. Findings provided preliminary evidence that RIs reduced client perceptions that their participation might influence how clinical and judicial staff view them. This suggests that using RIs may improve participant autonomy in clinical studies.
Acosta, Joie D.; Chinman, Matthew; Ebener, Patricia; Phillips, Andrea; Xenakis, Lea; Malone, Patrick S.
Restorative practices in schools lack rigorous evaluation studies. As an example of rigorous school-based research, this article describes the first randomized control trial of restorative practices to date, the Study of Restorative Practices. It is a 5-year, cluster-randomized controlled trial (RCT) of the Restorative Practices Intervention (RPI)…
Mountain, Gail A; Hind, Daniel; Gossage-Worrall, Rebecca; Walters, Stephen J; Duncan, Rosie; Newbould, Louise; Rex, Saleema; Jones, Carys; Bowling, Ann; Cattan, Mima; Cairns, Angela; Cooper, Cindy; Edwards, Rhiannon Tudor; Goyder, Elizabeth C
Loneliness in older people is associated with poor health-related quality of life (HRQoL). We undertook a parallel-group randomised controlled trial to evaluate the effectiveness and cost-effectiveness of telephone befriending for the maintenance of HRQoL in older people. An internal pilot tested the feasibility of the trial and intervention. Participants aged >74 years, with good cognitive function, living independently in one UK city were recruited through general practices and other sources, then randomised to: (1) 6 weeks of short one-to-one telephone calls, followed by 12 weeks of group telephone calls with up to six participants, led by a trained volunteer facilitator; or (2) a control group. The main trial required the recruitment of 248 participants in a 1-year accrual window, of whom 124 were to receive telephone befriending. The pilot specified three success criteria which had to be met in order to progress the main trial to completion: recruitment of 68 participants in 95 days; retention of 80% participants at 6 months; successful delivery of telephone befriending by local franchise of national charity. The primary clinical outcome was the Short Form (36) Health Instrument (SF-36) Mental Health (MH) dimension score collected by telephone 6 months following randomisation. We informed 9,579 older people about the study. Seventy consenting participants were randomised to the pilot in 95 days, with 56 (80%) providing valid primary outcome data (26 intervention, 30 control). Twenty-four participants randomly allocated to the research arm actually received telephone befriending due to poor recruitment and retention of volunteer facilitators. The trial was closed early as a result. The mean 6-month SF-36 MH scores were 78 (SD 18) and 71 (SD 21) for the intervention and control groups, respectively (mean difference, 7; 95% CI, -3 to 16). Recruitment and retention of participants to a definitive trial with a recruitment window of 1 year is feasible. For
Murray, Elizabeth; McAdam, Rodney
This article compares and contrasts the main quality standards in the highly regulated pharmaceutical industry with specific focus on Good Clinical Practice (GCP), the standard for designing, conducting, recording and reporting clinical trials involving human participants. Comparison is made to ISO quality standards, which can be applied to all industries and types of organisation. The study is then narrowed to that of contract research organisations (CROs) involved in the conduct of clinical trials. The paper concludes that the ISO 9000 series of quality standards can act as a company-wide framework for quality management within such organisations by helping to direct quality efforts on a long-term basis without any loss of compliance. This study is valuable because comparative analysis in this domain is uncommon.
Full Text Available HIV epidemiology informs prevention trial design and program planning. Nine clinical research centers (CRC in sub-Saharan Africa conducted HIV observational epidemiology studies in populations at risk for HIV infection as part of an HIV prevention and vaccine trial network. Annual HIV incidence ranged from below 2% to above 10% and varied by CRC and risk group, with rates above 5% observed in Zambian men in an HIV-discordant relationship, Ugandan men from Lake Victoria fishing communities, men who have sex with men, and several cohorts of women. HIV incidence tended to fall after the first three months in the study and over calendar time. Among suspected transmission pairs, 28% of HIV infections were not from the reported partner. Volunteers with high incidence were successfully identified and enrolled into large scale cohort studies. Over a quarter of new cases in couples acquired infection from persons other than the suspected transmitting partner.
Kamali, Anatoli; Price, Matt A.; Lakhi, Shabir; Karita, Etienne; Inambao, Mubiana; Sanders, Eduard J.; Anzala, Omu; Latka, Mary H.; Bekker, Linda-Gail; Kaleebu, Pontiano; Asiki, Gershim; Ssetaala, Ali; Ruzagira, Eugene; Allen, Susan; Farmer, Paul; Hunter, Eric; Mutua, Gaudensia; Makkan, Heeran; Tichacek, Amanda; Brill, Ilene K.; Fast, Pat; Stevens, Gwynn; Chetty, Paramesh; Amornkul, Pauli N.; Gilmour, Jill
HIV epidemiology informs prevention trial design and program planning. Nine clinical research centers (CRC) in sub-Saharan Africa conducted HIV observational epidemiology studies in populations at risk for HIV infection as part of an HIV prevention and vaccine trial network. Annual HIV incidence ranged from below 2% to above 10% and varied by CRC and risk group, with rates above 5% observed in Zambian men in an HIV-discordant relationship, Ugandan men from Lake Victoria fishing communities, men who have sex with men, and several cohorts of women. HIV incidence tended to fall after the first three months in the study and over calendar time. Among suspected transmission pairs, 28% of HIV infections were not from the reported partner. Volunteers with high incidence were successfully identified and enrolled into large scale cohort studies. Over a quarter of new cases in couples acquired infection from persons other than the suspected transmitting partner. PMID:25602351
Full Text Available ... protocol affect the trial's results. Comparison Groups In most clinical trials, researchers use comparison groups. This means ... study before you agree to take part. Randomization Most clinical trials that have comparison groups use randomization. ...
Full Text Available ... Trials About Clinical Trials Clinical trials are research studies that explore whether a medical strategy, treatment, or ... and Clinical Studies Web page. Children and Clinical Studies Learn more about Children and Clinical Studies Importance ...
Musumari, Patou; El-Saaidi, Christina; Techasrivichien, Teeranee; Suguimoto, S. Pilar; Ono Kihara, Masako; Kihara, Masahiro
the mean change in the wait-list control group at 4-weeks post-intervention. We will use standardized regression coefficients to calculate the effect of the intervention on our primary outcome with P values. We will conduct both intention to treat and as treated analysis. Results This study is funded by Hayao Nakayama Foundation for Science & Technology and Culture; Grant number H26-A2-41. The research and development approval has been obtained from Kyoto University Graduate School and Faculty of Medicine Ethics Committee, Japan, and Swaziland’s Ministry of Health Ethics and Scientific committee. Results are expected in February 2017. Conclusions This study will provide evidence on the efficiency of a mobile phone interactive game in increasing HIV risk perception in Swaziland. Our findings may also be generalizable to similar settings in SSA. Trial Registration University Hospital Medical Information Network Clinical Trial Registry ID number (UMIN-CTR):UMIN000021781; URL:https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025103 (Archived by WebCite at http://www.webcitation.org/6hOphB11a). PMID:27876685
Walker, Robrina; Morris, David W; Greer, Tracy L; Trivedi, Madhukar H
Descriptions of and recommendations for meeting the challenges of training research staff for multisite studies are limited despite the recognized importance of training on trial outcomes. The STRIDE (STimulant Reduction Intervention using Dosed Exercise) study is a multisite randomized clinical trial that was conducted at nine addiction treatment programs across the United States within the National Drug Abuse Treatment Clinical Trials Network (CTN) and evaluated the addition of exercise to addiction treatment as usual (TAU), compared to health education added to TAU, for individuals with stimulant abuse or dependence. Research staff administered a variety of measures that required a range of interviewing, technical, and clinical skills. In order to address the absence of information on how research staff are trained for multisite clinical studies, the current manuscript describes the conceptual process of training and certifying research assistants for STRIDE. Training was conducted using a three-stage process to allow staff sufficient time for distributive learning, practice, and calibration leading up to implementation of this complex study. Training was successfully implemented with staff across nine sites. Staff demonstrated evidence of study and procedural knowledge via quizzes and skill demonstration on six measures requiring certification. Overall, while the majority of staff had little to no experience in the six measures, all research assistants demonstrated ability to correctly and reliably administer the measures throughout the study. Practical recommendations are provided for training research staff and are particularly applicable to the challenges encountered with large, multisite trials.
Hoderlein, Xenia; Moseley, Anne M; Elkins, Mark R
Many clinical trials are reported without reference to the existing relevant high-quality research. This study aimed to investigate the extent to which authors of reports of clinical trials of physiotherapy interventions try to use high-quality clinical research to (1) help justify the need for the trial in the introduction and (2) help interpret the trial's results in the discussion. Data were extracted from 221 clinical trials that were randomly selected from the Physiotherapy Evidence Database: 70 published in 2001 (10% sample) and 151 published in 2015 (10% sample). The Physiotherapy Evidence Database score (which rates methodological quality and completeness of reporting) for each trial was also downloaded. Overall 41% of trial reports cited a systematic review or the results of a search for other evidence in the introduction section: 20% for 2001 and 50% for 2015 (relative risk = 2.3, 95% confidence interval = 1.5-3.8). For the discussion section, only 1 of 221 trials integrated the results of the trial into an existing meta-analysis, but citation of a relevant systematic review did increase from 17% in 2001 to 34% in 2015. There was no relationship between citation of existing research and the total Physiotherapy Evidence Database score. Published reports of clinical trials of physiotherapy interventions increasingly cite a systematic review or the results of a search for other evidence in the introduction, but integration with existing research in the discussion section is very rare. To encourage the use of existing research, stronger recommendations to refer to existing systematic reviews (where available) could be incorporated into reporting checklists and journal editorial guidelines.
Reuter, Katja; Ukpolo, Francis; Ward, Edward; Wilson, Melissa L; Angyan, Praveen
... 40 Protection of Environment 32 2010-07-01 2010-07-01 false Council. 1508.6 Section 1508.6 Protection of Environment COUNCIL ON ENVIRONMENTAL QUALITY TERMINOLOGY AND INDEX § 1508.6 Council. Council means the Council on Environmental Quality established by title II of the Act. ...
Mawocha, Samkeliso C; Fetters, Michael D; Legocki, Laurie J; Guetterman, Timothy C; Frederiksen, Shirley; Barsan, William G; Lewis, Roger J; Berry, Donald A; Meurer, William J
Adaptive clinical trials use accumulating data from enrolled subjects to alter trial conduct in pre-specified ways based on quantitative decision rules. In this research, we sought to characterize the perspectives of key stakeholders during the development process of confirmatory-phase adaptive clinical trials within an emergency clinical trials network and to build a model to guide future development of adaptive clinical trials. We used an ethnographic, qualitative approach to evaluate key stakeholders' views about the adaptive clinical trial development process. Stakeholders participated in a series of multidisciplinary meetings during the development of five adaptive clinical trials and completed a Strengths-Weaknesses-Opportunities-Threats questionnaire. In the analysis, we elucidated overarching themes across the stakeholders' responses to develop a conceptual model. Four major overarching themes emerged during the analysis of stakeholders' responses to questioning: the perceived statistical complexity of adaptive clinical trials and the roles of collaboration, communication, and time during the development process. Frequent and open communication and collaboration were viewed by stakeholders as critical during the development process, as were the careful management of time and logistical issues related to the complexity of planning adaptive clinical trials. The Adaptive Design Development Model illustrates how statistical complexity, time, communication, and collaboration are moderating factors in the adaptive design development process. The intensity and iterative nature of this process underscores the need for funding mechanisms for the development of novel trial proposals in academic settings.
Jocelyne R Benatar
Full Text Available OBJECTIVE: Information on the rights of subjects in clinical trials has become increasingly complex and difficult to understand. This study evaluates whether a simple booklet which is relevant to all research studies improves the understanding of rights needed for subjects to provide informed consent. METHODS: 21 currently used informed consent forms (ICF from international clinical trials were separated into information related to the specific research study, and general information on participants' rights. A booklet designed to provide information on participants' rights which used simple language was developed to replace this information in current ICF's Readability of each component of ICF's and the booklet was then assessed using the Flesch-Kincaid Reading ease score (FK. To further evaluate the booklet 282 hospital inpatients were randomised to one of three ways to present research information; a standard ICF, the booklet combined with a short ICF, or the booklet combined with a simplified ICF. Comprehension of information related to the research proposal and to participant's rights was assessed by questionnaire. RESULTS: Information related to participants' rights contributed an average of 44% of the words in standard ICFs, and was harder to read than information describing the clinical trial (FK 25 versus (vs. 41 respectively, p = 0.0003. The booklet reduced the number of words and improved FK from 25 to 42. The simplified ICF had a slightly higher FK score than the standard ICF (50 vs. 42. Comprehension assessed in inpatients was better for the booklet and short ICF 62%, (95% confidence interval (CI 56 to 67 correct, or simplified ICF 62% (CI 58 to 68 correct compared to 52%, (CI 47 to 57 correct for the standard ICF, p = 0.009. This was due to better understanding of questions on rights (62% vs. 49% correct, p = 0.0008. Comprehension of study related information was similar for the simplified and standard ICF (60% vs. 64
Benatar, Jocelyne R; Mortimer, John; Stretton, Matthew; Stewart, Ralph A H
Information on the rights of subjects in clinical trials has become increasingly complex and difficult to understand. This study evaluates whether a simple booklet which is relevant to all research studies improves the understanding of rights needed for subjects to provide informed consent. 21 currently used informed consent forms (ICF) from international clinical trials were separated into information related to the specific research study, and general information on participants' rights. A booklet designed to provide information on participants' rights which used simple language was developed to replace this information in current ICF's Readability of each component of ICF's and the booklet was then assessed using the Flesch-Kincaid Reading ease score (FK). To further evaluate the booklet 282 hospital inpatients were randomised to one of three ways to present research information; a standard ICF, the booklet combined with a short ICF, or the booklet combined with a simplified ICF. Comprehension of information related to the research proposal and to participant's rights was assessed by questionnaire. Information related to participants' rights contributed an average of 44% of the words in standard ICFs, and was harder to read than information describing the clinical trial (FK 25 versus (vs.) 41 respectively, p = 0.0003). The booklet reduced the number of words and improved FK from 25 to 42. The simplified ICF had a slightly higher FK score than the standard ICF (50 vs. 42). Comprehension assessed in inpatients was better for the booklet and short ICF 62%, (95% confidence interval (CI) 56 to 67) correct, or simplified ICF 62% (CI 58 to 68) correct compared to 52%, (CI 47 to 57) correct for the standard ICF, p = 0.009. This was due to better understanding of questions on rights (62% vs. 49% correct, p = 0.0008). Comprehension of study related information was similar for the simplified and standard ICF (60% vs. 64% correct, p = 0.68). A booklet
Dr. Christian Hinrichs, Investigator and Lasker Clinical Research Scholar in the Experimental Transplantation and Immunology Branch (ETIB), is leading a trial of avelumab in patients with recurrent respiratory papillomatosis (RRP). Learn more...
No ITER Council Meetings were held during 2000. However, two ITER EDA Meetings were held, one in Tokyo, January 19-20, and one in Moscow, June 29-30. The parties participating in these meetings were those that partake in the extended ITER EDA, namely the EU, the Russian Federation, and Japan. This document contains, a/o, the records of these meetings, the list of attendees, the agenda, the ITER EDA Status Reports issued during these meetings, the TAC (Technical Advisory Committee) reports and recommendations, the MAC Reports and Advice (also for the July 1999 Meeting), the ITER-FEAT Outline Design Report, the TAC Reports and Recommendations both meetings), Site requirements and Site Design Assumptions, the Tentative Sequence of technical Activities 2000-2001, Report of the ITER SWG-P2 on Joint Implementation of ITER, EU/ITER Canada Proposal for New ITER Identification
Scott R Rosas
Full Text Available Evaluative bibliometrics uses advanced techniques to assess the impact of scholarly work in the context of other scientific work and usually compares the relative scientific contributions of research groups or institutions. Using publications from the National Institute of Allergy and Infectious Diseases (NIAID HIV/AIDS extramural clinical trials networks, we assessed the presence, performance, and impact of papers published in 2006-2008. Through this approach, we sought to expand traditional bibliometric analyses beyond citation counts to include normative comparisons across journals and fields, visualization of co-authorship across the networks, and assess the inclusion of publications in reviews and syntheses. Specifically, we examined the research output of the networks in terms of the a presence of papers in the scientific journal hierarchy ranked on the basis of journal influence measures, b performance of publications on traditional bibliometric measures, and c impact of publications in comparisons with similar publications worldwide, adjusted for journals and fields. We also examined collaboration and interdisciplinarity across the initiative, through network analysis and modeling of co-authorship patterns. Finally, we explored the uptake of network produced publications in research reviews and syntheses. Overall, the results suggest the networks are producing highly recognized work, engaging in extensive interdisciplinary collaborations, and having an impact across several areas of HIV-related science. The strengths and limitations of the approach for evaluation and monitoring research initiatives are discussed.
US president Donald Trump has signed an executive order to re-establish the US National Space Council. The 12-member council will include key government officials with an interest in space exploration, including NASA’s acting administrator Robert Lightfoot and the secretaries of state, commerce and defence.
Peeters Grietens, Koen; Ribera, Joan Muela; Erhart, Annette; Hoibak, Sarah; Ravinetto, Raffaella M.; Gryseels, Charlotte; Dierickx, Susan; O'Neill, Sarah; Muela, Susanna Hausmann; D'Alessandro, Umberto
Collecting blood samples from individuals recruited into clinical research projects in sub-Saharan Africa can be challenging. Strikingly, one of the reasons for participant reticence is the occurrence of local rumors surrounding “blood stealing” or “blood selling.” Such fears can potentially have dire effects on the success of research projects—for example, high dropout rates that would invalidate the trial's results—and have ethical implications related to cultural sensitivity and informed consent. Though commonly considered as a manifestation of the local population's ignorance, these rumors represent a social diagnosis and a logical attempt to make sense of sickness and health. Born from historical antecedents, they reflect implicit contemporary structural inequalities and the social distance between communities and public health institutions. We aim at illustrating the underlying logic governing patients' fear and argue that the management of these beliefs should become an intrinsic component of clinical research. PMID:24821846
Moriwaka, F; Tashiro, K
The research concerning with the pathogenesis of amyotrophic lateral sclerosis (ALS) has been in steady progress in the last 10 years, including discovery of SOD mutation in familial ALS. Riluzole, by its inhibiting excitatory amino acid release, is the only drug, which has been demonstrated the neuroprotective activity in the randomised double-blind placebo-controlled clinical trials in patients with ALS, although many other clinical therapeutic trials for ALS patients has been carried out. We discussed the clinical trials being the under way, especially SR57746A, (1-[2-(naphth-2-yl)ethy]-4-(3-trifluoromethyl phenyl)-1, 2, 5, 6-tetrahydro-pyridine, hydrochloride), a non-peptide compound which has been shown to exhibit a wide range of neurotrophic effects both in vitro and in vivo, and its phase II study in Japan and two kinds of phase III studies ongoing in the United States, Canada and Europe. We also introduced the clinical guideline for practice and care of ALS patients proposed by American Academy of Neurology, expecting to establish clinical guideline to be applicable to Japanese cases.
Lukhele, Bhekumusa Wellington; Musumari, Patou; El-Saaidi, Christina; Techasrivichien, Teeranee; Suguimoto, S Pilar; Ono Kihara, Masako; Kihara, Masahiro
-list control group at 4-weeks post-intervention. We will use standardized regression coefficients to calculate the effect of the intervention on our primary outcome with P values. We will conduct both intention to treat and as treated analysis. This study is funded by Hayao Nakayama Foundation for Science & Technology and Culture; Grant number H26-A2-41. The research and development approval has been obtained from Kyoto University Graduate School and Faculty of Medicine Ethics Committee, Japan, and Swaziland's Ministry of Health Ethics and Scientific committee. Results are expected in February 2017. This study will provide evidence on the efficiency of a mobile phone interactive game in increasing HIV risk perception in Swaziland. Our findings may also be generalizable to similar settings in SSA. University Hospital Medical Information Network Clinical Trial Registry ID number (UMIN-CTR):UMIN000021781; URL:https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025103 (Archived by WebCite at http://www.webcitation.org/6hOphB11a). ©Bhekumusa Wellington Lukhele, Patou Musumari, Christina El-Saaidi, Teeranee Techasrivichien, S. Pilar Suguimoto, Masako Ono Kihara, Masahiro Kihara. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 22.11.2016.
Full Text Available Abstract Background With the increasing implementation of web-based, mobile health interventions in clinical trials, it is crucial for researchers to address the security and privacy concerns of patient information according to high ethical standards. The full process of meeting these standards is often made more complicated due to the use of internet-based technology and smartphones for treatment, telecommunication, and data collection; however, this process is not well-documented in the literature. Results The Smart Heart Trial is a single-arm feasibility study that is currently assessing the effects of a web-based, mobile lifestyle intervention for overweight and obese children and youth with congenital heart disease in Southwestern Ontario. Participants receive telephone counseling regarding nutrition and fitness; and complete goal-setting activities on a web-based application. This paper provides a detailed overview of the challenges the study faced in meeting the high standards of our Research Ethics Board, specifically regarding patient privacy. Conclusion We outline our solutions, successes, limitations, and lessons learned to inform future similar studies; and model much needed transparency in ensuring high quality security and protection of patient privacy when using web-based and mobile devices for telecommunication and data collection in clinical research.
Rodrigues, H C M L; Deprest, J; v d Berg, P P
In this article, we reflect on whether randomized controlled trials (RCTs) are adequate for the clinical evaluation of maternal-fetal surgery for congenital diaphragmatic hernia (CDH), focusing on the role of patients' preferences in the setting up of research protocols, on the requirement of equipoise and on the concept of therapeutic misconception (TM). We describe the conception and setting up of the tracheal occlusion (TO) to accelerate lung growth trial and analyze the ethical dilemmas faced by the research team during that time. Depending on the view adopted regarding the scope of equipoise, there are two ways of dealing with patient's preferences concerning fetoscopic endoluminal TO and expectant management during pregnancy for CDH. The solution adopted for fetoscopic endoluminal tracheal occlusion (FETO) is justified by the extended period of time it has been available to patients before the start of the RCT. Strong patient and referring physician preferences do not entail a right to have FETO, since it is a procedure of yet unproven efficacy and safety. In the future, to avoid the dilemmas posed by the TM and in name of the right of future generations of patients to have access to treatment of proven safety and efficacy, researchers must be able to plan RCT in due time. Copyright © 2011 John Wiley & Sons, Ltd.
Samadi, Aniseh; Asghari, Fariba
Obtaining informed consents is one of the most fundamental principles in conducting a clinical trial. In order for the consent to be informed, the patient must receive and comprehend the information appropriately. Complexity of the consent form is a common problem that has been shown to be a major barrier to comprehension for many patients. The objective of this study was to assess the readability of different templates of informed consent forms (ICFs) used in clinical trials in the Center for Research and Training in Skin Diseases and Leprosy (CRTSDL), Tehran, Iran. This study was conducted on ICFs of 45 clinical trials of the CRTSDL affiliated with Tehran University of Medical Sciences. ICFs were tested for reading difficulty, using the readability assessments formula adjusted for the Persian language including the Flesch–Kincaid reading ease score, Flesch–Kincaid grade level, and Gunning fog index. Mean readability score of the whole text of ICFs as well as their 7 main information parts were calculated. The mean ± SD Flesch Reading Ease score for all ICFs was 31.96 ± 5.62 that is in the difficult range. The mean ± SD grade level was calculated as 10.71 ± 1.8 (8.23–14.09) using the Flesch–Kincaid formula and 14.64 ± 1.22 (12.67–18.27) using the Gunning fog index. These results indicate that the text is expected to be understandable for an average student in the 11th grade, while the ethics committee recommend grade level 8 as the standard readability level for ICFs. The results showed that the readability scores of ICFs assessed in our study were not in the acceptable range. This means they were too complex to be understood by the general population. Ethics committees must examine the simplicity and readability of ICFs used in clinical trials. PMID:27471590
Niranjan, Soumya J; Durant, Raegan W; Wenzel, Jennifer A; Cook, Elise D; Fouad, Mona N; Vickers, Selwyn M; Konety, Badrinath R; Rutland, Sarah B; Simoni, Zachary R; Martin, Michelle Y
The study of disparities in minority recruitment to cancer clinical trials has focused primarily on inquiries among minority patient populations. However, clinical trial recruitment is complex and requires a broader appreciation of the multiple factors that influence minority participation. One area that has received little attention is minority recruitment training for professionals who assume various roles in the clinical trial recruitment process. Therefore, we assessed the perspectives of cancer center clinical and research personnel on their training and education needs toward minority recruitment for cancer clinical trials. Ninety-one qualitative interviews were conducted at five U.S. cancer centers among four stakeholder groups: cancer center leaders, principal investigators, referring clinicians, and research staff. Interviews were recorded and transcribed. Qualitative analyses focused on response data related to training for minority recruitment for cancer clinical trials. Four prominent themes were identified: (1) Research personnel are not currently being trained to focus on recruitment and retention of minority populations; (2) Training for minority recruitment and retention provides for a specific focus on factors influencing minority research participation; (3) Training on cultural awareness may help to bridge cultural gaps between potential minority participants and research professionals; (4) Views differ regarding the importance of research personnel training designed to focus on recruitment of minority populations. There is a lack of systematic training for minority recruitment. Many stakeholders acknowledged the benefits of minority recruitment training and welcomed training that focuses on increasing cultural awareness to increase the participation of minorities in cancer clinical trials.
Full Text Available Nurse involvement in research is essential to the expansion of nursing science and improved care for patients. The research participation challenges encountered by nurses providing direct care (direct care nurses include balancing patient care demands with research, adjusting to fluctuating staff and patient volumes, working with interdisciplinary personnel, and feeling comfortable with their knowledge of the research process. The purpose of this paper is to describe efforts to engage nurses in research for the Stories and Music for Adolescent/Young Adult Resilience during Transplant (SMART study. SMART was an NIH-funded, multisite, randomized, behavioral clinical trial of a music therapy intervention for adolescents/young adults (AYA undergoing stem cell transplant for an oncology condition. The study was conducted at 8 sites by a large multidisciplinary team that included direct care nurses, advanced practice nurses, and nurse researchers, as well as board-certified music therapists, clinical research coordinators, and physicians. Efforts to include direct care nurses in the conduct of this study fostered mutual respect across disciplines in both academic and clinical settings.
The NRC published two reports over a twenty year span. They concluded that there is no documented scientific evidence that sewage sludge regulations have failed to protect public health, but identified areas of research.
Full Text Available Mental Retardation (MR is a developmental disability characterized by impairments in adaptive daily life skills and difficulties in social and interpersonal functioning. Since multiple causes may contribute to MR, associated clinical pictures may vary accordingly. Nevertheless, when psychiatric disorders as Treatment Resistant Depression (TRD and/or alcohol abuse co-exist, their proper detection and management is often troublesome, essentially due to a limited vocabulary MR people could use to describe their symptoms, feelings and concerns, and the lack of reliable screening tools. Furthermore, MR people are among the most medicated subjects, with (over prescription of antidepressants and/or typical antipsychotics being the rule rather than exception. Thus, treatment resistance or even worsening of depression, constitute frequent occurrences. This report describes the case of a person with MR who failed to respond to repetitive trials of antidepressant monotherapies, finally recovering using aripiprazole to fluvoxamine augmentation upon consideration of a putative bipolar diathesis for “agitated” TRD. Although further controlled investigations are needed to assess a putative bipolar diathesis in some cases of MR associated to TRD, prudence is advised in the long-term prescription of antidepressant monotherapies in such conditions.
Farkouh, M.E.; Kirshner, H.; Harrington, R.A.; Ruland, S.; Verheugt, F.W.A.; Schnitzer, T.J.; Burmester, G.R.; Mysler, E.; Hochberg, M.C.; Doherty, M.; Ehrsam, E.; Gitton, X.; Krammer, G.; Mellein, B.; Gimona, A.; Matchaba, P.; Hawkey, C.J.; Chesebro, J.H.
BACKGROUND: The potential for cyclo-oxygenase 2 (COX2)-selective inhibitors to increase the risk for myocardial infarction is controversial. The Therapeutic Arthritis Research and Gastrointestinal Event Trial (TARGET) aimed to assess gastrointestinal and cardiovascular safety of the COX2 inhibitor
Nelson, Geoffrey; Macnaughton, Eric; Goering, Paula
Using the case of a large-scale, multi-site Canadian Housing First research demonstration project for homeless people with mental illness, At Home/Chez Soi, we illustrate the value of qualitative methods in a randomized controlled trial (RCT) of a complex community intervention. We argue that quantitative RCT research can neither capture the complexity nor tell the full story of a complex community intervention. We conceptualize complex community interventions as having multiple phases and dimensions that require both RCT and qualitative research components. Rather than assume that qualitative research and RCTs are incommensurate, a more pragmatic mixed methods approach was used, which included using both qualitative and quantitative methods to understand program implementation and outcomes. At the same time, qualitative research was used to examine aspects of the intervention that could not be understood through the RCT, such as its conception, planning, sustainability, and policy impacts. Through this example, we show how qualitative research can tell a more complete story about complex community interventions. Copyright © 2015 Elsevier Inc. All rights reserved.
von Niederhäusern, Belinda; Fabbro, Thomas; Pauli-Magnus, Christiane
Six multidisciplinary competence centres (Clinical Trial Units, CTUs) in Basel, Berne, Geneva, Lausanne, St. Gallen and Zurich provide professional support to clinical researchers in the planning, implementation, conduct and evaluation of clinical studies. Through their coordinated network, these units promote high-quality, nationally harmonised and internationally standardised clinical research conduct in Switzerland. We will describe why this network has been established, how it has been successful in stilling the growing need for clinical research support, which training and education opportunities it offers, and how it created national awareness for the still-existing hurdles towards clinical research excellence in Switzerland. Taking the CTU Basel as an example, we show that a considerable number (25%) of the studies submitted for regulatory approval in 2013 were supported by the CTU, decreasing the number of findings in ethics reviews by about one-third. We conclude that these achievements, together with a Swiss national funding model for clinical research, and improved national coordination, will be critical factors to successfully position Swiss clinical research at the international forefront.
Why do patients decline surgical trials? Findings from a qualitative interview study embedded in the Cancer Research UK BOLERO trial (Bladder cancer: Open versus Lapararoscopic or RObotic cystectomy).
Harrop, Emily; Kelly, John; Griffiths, Gareth; Casbard, Angela; Nelson, Annmarie
Surgical trials have typically experienced recruitment difficulties when compared with other types of oncology trials. Qualitative studies have an important role to play in exploring reasons for low recruitment, although to date few such studies have been carried out that are embedded in surgical trials. The BOLERO trial (Bladder cancer: Open versus Lapararoscopic or RObotic cystectomy) is a study to determine the feasibility of randomisation to open versus laparoscopic access/robotic cystectomy in patients with bladder cancer. We describe the results of a qualitative study embedded within the clinical trial that explored why patients decline randomisation. Ten semi-structured interviews with patients who declined randomisation to the clinical trial, and two interviews with recruiting research nurses were conducted. Data were analysed for key themes. The majority of patients declined the trial because they had preferences for a particular treatment arm, and in usual practice could choose which surgical method they would be given. In most cases the robotic option was preferred. Patients described an intuitive 'sense' that favoured the new technology and had carried out their own inquiries, including Internet research and talking with previous patients and friends and family with medical backgrounds. Medical histories and lifestyle considerations also shaped these personalised choices. Of importance too, however, were the messages patients perceived from their clinical encounters. Whilst some patients felt their surgeon favoured the robotic option, others interpreted 'indirect' cues such as the 'established' reputation of the surgeon and surgical method and comments made during clinical assessments. Many patients expressed a wish for greater direction from their surgeon when making these decisions. For trials where the 'new technology' is available to patients, there will likely be difficulties with recruitment. Greater attention could be paid to how messages about
Parker, Melissa J; de Laat, Sonya; Schwartz, Lisa
Introduction Prospective informed consent is required for most research involving human participants; however, this is impracticable under some circumstances. The Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS) outlines the requirements for research involving human participants in Canada. The need for an exception to consent (deferred consent) is recognised and endorsed in the TCPS for research in individual medical emergencies; however, little is known abou...
Chaudhry Shazia H
Full Text Available Abstract Background Cluster randomized trials are an increasingly important methodological tool in health research. In cluster randomized trials, intact social units or groups of individuals, such as medical practices, schools, or entire communities – rather than individual themselves – are randomly allocated to intervention or control conditions, while outcomes are then observed on individual cluster members. The substantial methodological differences between cluster randomized trials and conventional randomized trials pose serious challenges to the current conceptual framework for research ethics. The ethical implications of randomizing groups rather than individuals are not addressed in current research ethics guidelines, nor have they even been thoroughly explored. The main objectives of this research are to: (1 identify ethical issues arising in cluster trials and learn how they are currently being addressed; (2 understand how ethics reviews of cluster trials are carried out in different countries (Canada, the USA and the UK; (3 elicit the views and experiences of trial participants and cluster representatives; (4 develop well-grounded guidelines for the ethical conduct and review of cluster trials by conducting an extensive ethical analysis and organizing a consensus process; (5 disseminate the guidelines to researchers, research ethics boards (REBs, journal editors, and research funders. Methods We will use a mixed-methods (qualitative and quantitative approach incorporating both empirical and conceptual work. Empirical work will include a systematic review of a random sample of published trials, a survey and in-depth interviews with trialists, a survey of REBs, and in-depth interviews and focus group discussions with trial participants and gatekeepers. The empirical work will inform the concurrent ethical analysis which will lead to a guidance document laying out principles, policy options, and rationale for proposed guidelines. An
Minaya, Gabriela E; Fuentes-Delgado, Duilio J; Ugalde, Antonio; Homedes, Núria
Most regulatory agencies conduct clinical trial (CT) site inspections, but the experiences and behaviors of research subjects and their knowledge of the rights and obligations that ensue from participating in a CT are seldom explored. The authors assessed the technical feasibility of incorporating interviews with participants in CT inspections. This article analyzes the responses of 13 CT participants, 14% ( n = 96) of those included in three tuberculosis (TB) CTs. Participants did not object to being interviewed and provided information not obtained during regular inspections. Participants were appreciative of the agency's concern for the integrity of the CT process. Most interviewees did not understand the consent form and were unaware that they were participating in an experiment with unapproved new drugs. Participants' decision to enroll in CT related to undue inducement and therapeutic misconception. Some patients' behaviors, undisclosed to researchers, could have compromised the integrity of the data collected.
Jaarsma, T.; Deaton, C.; Fitzsimmons, D.; Fridlund, B.; Hardig, B.M.; Mahrer-Imhof, R.; Moons, P.; Noureddine, S.; O'Donnell, S.; Pedersen, S.S.; Stewart, S.; Stromberg, A.; Thompson, D.R.; Tokem, Y.; Kjellstrom, B.
To deliver optimal patient care, evidence-based care is advocated and research is needed to support health care staff of all disciplines in deciding which options to use in their daily practice. Due to the increasing complexity of cardiac care across the life span of patients combined with the
The CERN Council today thanked the Organization’s outgoing management, and welcomed in the new. Outgoing Director General Robert Aymar, looked back on his five years at the helm, while new Director General, Rolf Heuer, presented his vision for the future. In other Council business, Romania was welcomed as a Candidate for Accession as Member State of CERN; and the groundwork was laid for a study of geographical and scientific extension of the role of CERN. Council also established the practical procedures for following projects relevant to the European Strategy for Particle Physics. Consult the complete Press Release.
Bradford, Andrew; Lees, Kennedy
Abstract The Intravenous Magnesium Efficacy in Acute Stroke (IMAGES) trial is a multicentre,randomised, placebo-controlled trial of magnesium sulphate (MgSO4) funded by the UK Medical Research Council. When complete, it will be the largest single neuroprotective study undertaken to date. Conscious patients presenting within 12 h of acute stroke with limb weakness are eligible. The primary outcome measure is combined death and disability as measured using the Barthel Index at 90-day follow up....
Bradford, A.; Lees, K.
The Intravenous Magnesium Efficacy in Acute Stroke (IMAGES) trial is a multicentre,randomised, placebo-controlled trial of magnesium sulphate (MgSO4) funded by the UK Medical Research Council. When complete, it will be the largest single neuroprotective study undertaken to date. Conscious patients presenting within 12 h of acute stroke with limb weakness are eligible. The primary outcome measure is combined death and disability as measured using the Barthel Index at 90-day follow up. By rando...
Noboa-Ortega, Patricia; Figueroa-Cosme, Wanda I; Feldman-Soler, Alana; Miranda-Díaz, Christine
"Arte con Salud" is an HIV/AIDS prevention intervention tailored for Puerto Rican women who have sex with men. The intervention curriculum was refined through a community-academic collaboration between Taller Salud, the UPRCayey Campus, and the UCC-School of Medicine, subsided in 2012-13 by PRCTRC. The collaboration has been crucial to validate the impact of using art as a tool to facilitate sexual negotiation skills and safer sexual practices among adult women have sex with men participating in HIV prevention education. This article describes the vision, valley, victory phases endured to establish a community-academia partnership based on the CPPR framework as an effective mean to implement a randomized controlled trial intervention (RCT). We also discuss the barriers, outcomes, and lessons learned from this partnership. Some of the identified solutions include: setting goals to secure funding, regular meetings, and the inclusion of undergraduate level students to assist in the implementation of the intervention. These solutions helped to build trust among the community and academic partners. As a result of this collaboration, a total of 86 participants were enrolled and 5 competitive research grants have been submitted. The community-academic collaboration was essential in order to build a solid research infrastructure that addresses the complexities of HIV prevention education among groups of Puerto Rican women.
Federal Agencies and improve the data available to the research community. -4- MILESTONES: • Field verification and ground truth establishment...knowledge of subsurface properties, linking sampling schemes to new models incorporating this information. New ( Bayesian -like) approaches would be...but with L-glutamine and supplemented with 10% each of fetal calf and calf serum and antibiotics. As an initial step in the work, it is proposed
Full Text Available Writing policy that applies to First Nations, Inuit and Métis peoples in Canada has become more interactive as communities and their representative organizations press for practical recognition of an Aboriginal right of self-determination. When the policy in development is aimed at supporting “respect for human dignity” as it is in the case of ethics of research involving humans, the necessity of engaging the affected population becomes central to the undertaking.
Full Text Available ... Entire Site NHLBI Entire Site Health Topics News & Resources Intramural Research ... or device is safe and effective for humans. What Are Clinical Trials? Clinical trials are research ...
Full Text Available ... decisionmaking. The purpose of clinical trials is research, so the studies follow strict scientific standards. These standards ... otherwise. The purpose of clinical trials is research, so the studies follow strict scientific standards. These standards ...
Full Text Available ... trials are research studies that explore whether a medical strategy, treatment, or device is safe and effective ... trials are research studies that explore whether a medical strategy, treatment, or device is safe and effective ...
Full Text Available ... treatment, or device is safe and effective for humans. What Are Clinical Trials? Clinical trials are research ... are required to have an IRB. Office for Human Research Protections The U.S. Department of Health and ...
Full Text Available ... best data available for health care decisionmaking. The purpose of clinical trials is research, so the studies ... Thus, research in humans is needed. For safety purposes, clinical trials start with small groups of patients ...
McKenzie, Joanne E; Herbison, G Peter; Roth, Paul; Paul, Charlotte
Recent cohort studies of randomised controlled trials have provided evidence of within-study selective reporting bias; where statistically significant outcomes are more likely to be more completely reported compared to non-significant outcomes. Bias resulting from selective reporting can impact on meta-analyses, influencing the conclusions of systematic reviews, and in turn, evidence based clinical practice guidelines.In 2006 we received funding to investigate if there was evidence of within-study selective reporting in a cohort of RCTs submitted to New Zealand Regional Ethics Committees in 1998/99. This research involved accessing ethics applications, their amendments and annual reports, and comparing these with corresponding publications. We did not plan to obtain informed consent from trialists to view their ethics applications for practical and scientific reasons. In November 2006 we sought ethical approval to undertake the research from our institutional ethics committee. The Committee declined our application on the grounds that we were not obtaining informed consent from the trialists to view their ethics application. This initiated a seventeen month process to obtain ethical approval. This publication outlines what we planned to do, the issues we encountered, discusses the legal and ethical issues, and presents some potential solutions. Methodological research such as this has the potential for public benefit and there is little or no harm for the participants (trialists) in undertaking it. Further, in New Zealand, there is freedom of information legislation, which in this circumstance, unambiguously provided rights of access and use of the information in the ethics applications. The decision of our institutional ethics committee defeated this right and did not recognise the nature of this observational research. Methodological research, such as this, can be used to develop processes to improve quality in research reporting. Recognition of the potential
Jackson, Jeanne; Mandel, Deborah; Blanchard, Jeanine; Carlson, Mike; Cherry, Barbara; Azen, Stanley; Chou, Chih-Ping; Jordan-Marsh, Maryalice; Forman, Todd; White, Brett; Granger, Douglas; Knight, Bob; Clark, Florence
Community-dwelling older adults are at risk for declines in physical health, cognition, and psychosocial well-being. However, their enactment of active and health-promoting lifestyles can reduce such declines. The purpose of this article is to describe the USC Well Elderly II study, a randomized clinical trial designed to test the effectiveness of a healthy lifestyle program for elders, and document how various methodological challenges were addressed during the course of the trial. In the study, 460 ethnically diverse elders recruited from a variety of sites in the urban Los Angeles area were enrolled in a randomized experiment involving a crossover design component. Within either the first or second 6-month phase of their study involvement, each elder received a lifestyle intervention designed to improve a variety of aging outcomes. At 4-5 time points over an 18-24 month interval, the research participants were assessed on measures of healthy activity, coping, social support, perceived control, stress-related biomarkers, perceived physical health, psychosocial well-being, and cognitive functioning to test the effectiveness of the intervention and document the process mechanisms responsible for its effects. The study protocol was successfully implemented, including the enrollment of study sites, the recruitment of 460 older adults, administration of the intervention, adherence to the plan for assessment, and establishment of a large computerized data base. Methodological challenges were encountered in the areas of site recruitment, participant recruitment, testing, and intervention delivery. The completion of clinical trials involving elders from numerous local sites requires careful oversight and anticipation of threats to the study design that stem from: (a) social situations that are particular to specific study sites; and (b) physical, functional, and social challenges pertaining to the elder population.
Full Text Available Abstract Background The purpose of this research is to develop and evaluate methods for conducting pragmatic cluster randomized trials in a primary care electronic database. The proposal describes one application, in a less frequent chronic condition of public health importance, secondary prevention of stroke. A related protocol in antibiotic prescribing was reported previously. Methods/Design The study aims to implement a cluster randomized trial (CRT using the electronic patient records of the General Practice Research Database (GPRD as a sampling frame and data source. The specific objective of the trial is to evaluate the effectiveness of a computer-delivered intervention at enhancing the delivery of stroke secondary prevention in primary care. GPRD family practices will be allocated to the intervention or usual care. The intervention promotes the use of electronic prompts to support adherence with the recommendations of the UK Intercollegiate Stroke Working Party and NICE guidelines for the secondary prevention of stroke in primary care. Primary outcome measure will be the difference in systolic blood pressure between intervention and control trial arms at 12-month follow-up. Secondary outcomes will be differences in serum cholesterol, prescribing of antihypertensive drugs, statins, and antiplatelet therapy. The intervention will continue for 12 months. Information on the utilization of the decision-support tools will also be analyzed. Discussion The CRT will investigate the effectiveness of using a computer-delivered intervention to reduce the risk of stroke recurrence following a first stroke event. The study will provide methodological guidance on the implementation of CRTs in electronic databases in primary care. Trial registration Current Controlled Trials ISRCTN35701810
... in the selection of Council members include candidates' proven experience in developing and marketing... contact information such as mailing address, fax, e-mail, fixed and mobile phone numbers and support staff...
Taylor, Joseph; Kowalski, Susan; Getty, Stephen; Wilson, Christopher; Carlson, Janet
Effective instructional materials can be valuable interventions to improve student interest and achievement in science (National Research Council [NRC], 2007); yet, analyses indicate that many science instructional materials and curricula are fragmented, lack coherence, and are not carefully articulated through a sequence of grade levels (AAAS,…
Full Text Available Clinical research plays a fundamental role in establishing new treatments. Clinical research coordinators are considered essential in clinical research, and medical professionals such as pharmacists often take on this role. Pharmacy students can be considered future candidates for this task. We used questionnaires to survey the knowledge of and attitudes toward registration trials and clinical research of pharmacy students at Tokushima University Hospital. All pharmacy students (103 to whom questionnaires were sent responded. Almost all respondents were aware of registration trials and clinical research. More than 90% were aware of the existence of clinical research coordinators, and about half (48.6% understood their role. In clinical research terminology, most respondents were aware of informed consent and related issues, but fewer than 20% were aware of more practical things. In total, 29.1% and 40.8% of the respondents were willing to carry out and coordinate research. These findings suggest that pharmacy students have basic knowledge of clinical research and that many students are willing to carry out and coordinate clinical research. More practical exposure to clinical research may help to strengthen their future contribution. Further studies may help to determine how to provide education on registration trials and clinical research to pharmacy students.
Norris, Karen; Shannon, Tom
In December 1995, the National Safety Council (NSC) entered into Cooperative Agreement No.DE-FC02-96EW 12729 with the US Department of Energy (DOE) to work together over the next few years on safety and health initiatives surrounding the management of radioactive materials. As a result, three publications, including print and non-print deliverables, were developed and distributed: (1) Series of Backgrounders, Web Services for WIPP; (2) A Guide to Foreign Research Reactor Spent Fuel; and (3) A Guide to the US Department of Energy's Low-Level Radioactive Waste. DOE and its predecessor agencies have maintained a record of safe transportation of radioactive materials for more than 50 years. Thousands of shipments involving three million packages of radioactive materials are shipped each year in the United States. Historically, DOE shipments constitute less than one percent of the total radioactive material shipments; however, they comprise a significant portion (approaching 75 percent) of the curies, or amounts of radioactivity shipped annually. DOE operations and field offices are responsible for detailed planning and for ensuring full regulatory compliance for their shipments. Packaging is designed to protect workers and limit the risk to the public during transportation. DOE headquarters and program offices provide policy direction and oversight for packaging and transportation activities for their respective offices. The publications NSC produced under the agreement also included primary points of contact for external audiences, including the press, the public, and stakeholders who would not have access to DOE regulations, manuals, and practices
... Evaluation; Advisory Council on Alzheimer's Research, Care, and Services AGENCY: Department of Health and... Alzheimer's Research, Care, and Services to fill the position of representative of a voluntary health... Council on Alzheimer's Research, Care, and Services meets quarterly to discuss programs that impact people...
The thermonuclear fusion is in an early development state and has however in principle possible advantages which could be especially valuable for Europe. The primary fusion fuels (D, Li) are plentiful existent, wide spread and cheap (1 g natural Lithium could generate 15 MHW); both fuels and the end product of the reactions - Helium - are stable. From the nuclear-technological point of view a thermonuclear reactor could be built with high safety; the doubling time for breeding of new fuels in principle could be very short. These potential advantages however are balanced by certain disadvantages, e.g. high costs for the construction of a thermonuclear reactor etc. The research program, other possibilities and the costs are outlined. (orig./HT) [de
The thermonuclear fusion is in a early development state and has, however, in principle possible advantages which could be especially valuable for Europe: the primary fusion fuels (D, Li) are plentiful existent, wide spread and cheap (1 g natural Lithium could generate 15 MWh); both fuels and the end product of the reactions - Helium - are stable. From the nuclear-technological point of view a thermonuclear reactor could be built with high safety; the doubling time for breeding of new fuels in principle could be very short. These potential advantages, however, are balanced by certain disadvantages, e.g. high costs for the construction of a thermonuclear reactor etc. The research program, other possibilities and the costs are outlined. (orig./HT) [de
van Wyk, Christa
The constitutional prohibition of experimentation/research without the individual subject's (own) consent is investigated. A distinction is drawn between therapeutic and non-therapeutic research. A minor of 14 is competent to consent independently to medical treatment (which would include therapeutic research), but not to non-therapeutic research. A minor must be at least 18 years to be able to do so. Proxy consent can be secured for the participation of minors under 18 in non-therapeutic research only if they assent, if their participation in the research is indispensable and the research carries no more than negligible risk. Since the risks inherent in HIV preventive vaccine trials may carry more than negligible risk, these trials may not be carried out on children under 18. The limitation of rights and the consideration of foreign and international law in the interpretation of the South African Bill of Rights are investigated.
... SMALL BUSINESS ADMINISTRATION National Women's Business Council ACTION: Notice of open Federal..., and agenda for the next meeting of the National Women's Business Council (NWBC). The meeting will be... the meeting of the National Women's Business Council. The National Women's Business Council is tasked...
... SMALL BUSINESS ADMINISTRATION National Women's Business Council AGENCY: U.S. Small Business... Business Council (NWBC). The meeting will be open to the public. DATES: The meeting will be held on July 17... Business Council. The National Women's Business Council is tasked with providing policy recommendations on...
Council. The affairs and property of the Academy are administered by a Council of 20, consisting of a President, four Vice-Presidents, a Treasurer, two Secretaries, and twelve other members. The Council, with a term of three years, is elected by the Fellows triennially. Members of the Council for the period 2016 to 2018:.
... Pacific Fishery Management Council's (Pacific Council) Groundfish Management Team (GMT) [[Page 55364... Fishery Management Council; Public Meeting AGENCY: National Marine Fisheries Service (NMFS), National...; telephone: (206) 526-6150. Council address: Pacific Fishery Management Council, 7700 NE Ambassador Place...
... Pacific Fishery Management Council's (Pacific Council) Highly Migratory Species Management Team (HMSMT... Fishery Management Council; Public Meeting AGENCY: National Marine Fisheries Service (NMFS), National.... Council address: Pacific Fishery Management Council, 7700 NE. Ambassador Place, Suite 101, Portland, OR...
... Pacific Fishery Management Council's (Council) Groundfish Management Team (GMT) will hold a working... Fishery Management Council; Public Meeting AGENCY: National Marine Fisheries Service (NMFS), National.... Council address: Pacific Fishery Management Council, 7700 NE. Ambassador Place, Suite 101, Portland, OR...
A cluster-randomised controlled trial integrating a community-based water, sanitation and hygiene programme, with mass distribution of albendazole to reduce intestinal parasites in Timor-Leste: the WASH for WORMS research protocol
Nery, Susana Vaz; McCarthy, James S; Traub, Rebecca; Andrews, Ross M; Black, Jim; Gray, Darren; Weking, Edmund; Atkinson, Jo-An; Campbell, Suzy; Francis, Naomi; Vallely, Andrew; Williams, Gail; Clements, Archie
by a Partnership for Better Health—Project grant from the National Health and Research Council (NHMRC), Australia. Trial registration number ACTRN12614000680662; Pre-results PMID:26719316
"Conclusions about exposure to ETS and health that will be unhelpful to us": how the tobacco industry attempted to delay and discredit the 1997 Australian National Health and Medical Research Council report on passive smoking.
Trotter, L; Chapman, S
Major reviews of the health effects of passive smoking have been subjected to tobacco industry campaigns to refute the scientific evidence. Following the 1992 US Environmental Protection Agency review, the Australian National Health and Medical Research Council (NHMRC) initiated a review of the health effects of passive smoking. At the time of this review, evidence that environmental tobacco smoke causes disease was being increasingly accepted in courts of law and voluntary adoption of smoking restrictions was rapidly growing. To demonstrate how the tobacco industry attempted to delay and discredit the publication of a report on passive smoking that the tobacco industry anticipated to contain recommendations that would be unfavourable to their business. A search of tobacco industry documents on the Master Settlement Agreement websites was conducted using the terms and acronyms representative of the NHMRC review. The tobacco industry sought to impede the progress of the NHMRC Working Party by launching an intensive campaign to delay and discredit the report. The main strategies used were attempts to criticise the science, extensive use of Freedom of Information provisions to monitor all activity of the group, legal challenges, ad hominem attacks on the credibility of the Working Party members, rallying support from industry allies, and influencing public opinion through the media. The Australian tobacco industry deliberately impeded the NHMRC Working Party's progress and successfully prevented the publication of the report's recommendations. The tobacco industry's motivation and capacity to disrupt the advancement of scientific knowledge and policy in tobacco control should be recognised and anticipated.
Boulkedid, R; Abdou, A Y; Desselas, E; Monégat, M; de Leeuw, T G; Avez-Couturier, J; Dugue, S; Mareau, C; Charron, B; Alberti, C; Kaguelidou, F
Chronic pain is associated with significant functional and social impairment. The objective of this review was to assess the characteristics and quality of randomized controlled trials (RCTs) evaluating pain management interventions in children and adolescents with chronic pain. We performed a systematic search of PubMed, Embase and the Cochrane Library up to July 2017. We included RCTs that involved children and adolescents (3 months-18 years) and evaluated the use of pharmacological or non-pharmacological intervention(s) in the context of pain persisting or re-occurring for more than 3 months. Methodological quality was evaluated using the Cochrane Risk of Bias (ROB) Tool. A total of 58 RCTs were identified and numbers steadily increased over time. The majority were conducted in single hospital institutions, with no information on study funding. Median sample size was 47.5 participants (Q1,Q3: 32, 70). Forty-five percent of RCTs included both adults and children and the median of the mean ages at inclusion was 12.9 years (Q1,Q3: 11, 15). Testing of non-pharmacological interventions was predominant and only 5 RCTs evaluated analgesics or co-analgesics. Abdominal pain, headache/migraine and musculoskeletal pain were the most common types of chronic pain among participants. Methodological quality was poor with 90% of RCTs presenting a high or unclear ROB. Evaluation of analgesics targeting chronic pain relief in children and adolescents through RCTs is marginal. Infants and children with long-lasting painful conditions are insufficiently represented in RCTs. We discuss possible research constraints and challenges as well as methodologies to circumvent them. There is a substantial research gap regarding analgesic interventions for children and adolescents with chronic pain. Most clinical trials in the field focus on the evaluation of non-pharmacological interventions and are of low methodological quality. There is also a specific lack of trials involving infants
Spieker, Elena A.; Sbrocco, Tracy; Theim, Kelly R.; Maurer, Douglas; Johnson, Dawn; Bryant, Edny; Bakalar, Jennifer L.; Schvey, Natasha A.; Ress, Rachel; Seehusen, Dean; Klein, David A.; Stice, Eric; Yanovski, Jack A.; Chan, Linda; Gentry, Shari; Ellsworth, Carol; Hill, Joanne W.; Tanofsky-Kraff, Marian; Stephens, Mark B.
Obesity impacts the U.S. military by affecting the health and readiness of active duty service members and their families. Preventing Obesity in Military Communities (POMC) is a comprehensive research program within Patient Centered Medical Homes (PCMHs) in three Military Training Facilities. This paper describes three pilot randomized controlled trials that target critical high risk periods for unhealthy weight gain from birth to young adulthood: (1) pregnancy and early infancy (POMC-Mother-Baby), (2) adolescence (POMC-Adolescent), and (3) the first tour of duty after boot camp (POMC-Early Career). Each study employs a two-group randomized treatment or prevention program with follow up. POMC offers a unique opportunity to bring together research and clinical expertise in obesity prevention to develop state-of-the-art programs within PCMHs in Military Training Facilities. This research builds on existing infrastructure that is expected to have immediate clinical benefits to DoD and far-reaching potential for ongoing collaborative work. POMC may offer an economical approach for widespread obesity prevention, from conception to young adulthood, in the U.S. military as well as in civilian communities. PMID:25648176
Charles T. Eason
Full Text Available The therapeutic benefits of Greenshell™ mussel (GSM; Perna canaliculus preparations have been studied using in vitro test systems, animal models, and human clinical trials focusing mainly on anti-inflammatory and anti-arthritic effects. Activity is thought to be linked to key active ingredients that include omega-3 polyunsaturated fatty acids, a variety of carotenoids and other bioactive compounds. In this paper, we review the studies that have been undertaken in dogs, cats, and horses, and outline new research directions in shellfish breeding and high-value nutrition research programmes targeted at enhancing the efficacy of mussel and algal extracts. The addition of GSM to animal diets has alleviated feline degenerative joint disease and arthritis symptoms, and chronic orthopaedic pain in dogs. In horses, GSM extracts decreased the severity of lameness and joint pain and provided improved joint flexion in limbs with lameness attributed to osteoarthritis. Future research in this area should focus on elucidating the key active ingredients in order to link concentrations of these active ingredients with their pharmacokinetics and therapeutic effects. This would enable consistent and improved efficacy from GSM-based products for the purpose of improved animal health.
Information about the several types of cancer clinical trials, including treatment trials, prevention trials, screening trials, supportive and palliative care trials. Each type of trial is designed to answer different research questions.
... Alcohol Abuse and Alcoholism, National Advisory Council on Drug Abuse, and National Cancer Advisory Board... Advisory Council on Alcohol Abuse and Alcoholism, National Advisory Council on Drug Abuse, and National...: National Advisory Council on Alcohol Abuse and Alcoholism, National Advisory Council on Drug Abuse, and...
Patrick, Kevin; Wolszon, Laura; Basen-Engquist, Karen M; Demark-Wahnefried, Wendy; Prokhorov, Alex V; Barrera, Stephanie; Baru, Chaitan; Farcas, Emilia; Krueger, Ingolf; Palmer, Doug; Raab, Fred; Rios, Phil; Ziftci, Celal; Peterson, Susan
Improved approaches and methodologies are needed to conduct comparative effectiveness research (CER) in oncology. While cancer therapies continue to emerge at a rapid pace, the review, synthesis, and dissemination of evidence-based interventions across clinical trials lag in comparison. Rigorous and systematic testing of competing therapies has been clouded by age-old problems: poor patient adherence, inability to objectively measure the environmental influences on health, lack of knowledge about patients' lifestyle behaviors that may affect cancer's progression and recurrence, and limited ability to compile and interpret the wide range of variables that must be considered in the cancer treatment. This lack of data integration limits the potential for patients and clinicians to engage in fully informed decision-making regarding cancer prevention, treatment, and survivorship care, and the translation of research results into mainstream medical care. Particularly important, as noted in a 2009 report on CER to the President and Congress, the limited focus on health behavior-change interventions was a major hindrance in this research landscape (DHHS 2009). This paper describes an initiative to improve CER for cancer by addressing several of these limitations. The Cyberinfrastructure for Comparative Effectiveness Research (CYCORE) project, informed by the National Science Foundation's 2007 report "Cyberinfrastructure Vision for 21(st) Century Discovery" has, as its central aim, the creation of a prototype for a user-friendly, open-source cyberinfrastructure (CI) that supports acquisition, storage, visualization, analysis, and sharing of data important for cancer-related CER. Although still under development, the process of gathering requirements for CYCORE has revealed new ways in which CI design can significantly improve the collection and analysis of a wide variety of data types, and has resulted in new and important partnerships among cancer researchers engaged in
Cunningham, John A; Godinho, Alexandra; Kushnir, Vladyslav
Mechanical Turk (MTurk) is an online portal operated by Amazon where 'requesters' (individuals or businesses) can submit jobs for 'workers.' MTurk is used extensively by academics as a quick and cheap means of collecting questionnaire data, including information on alcohol consumption, from a diverse sample of participants. We tested the feasibility of recruiting for alcohol Internet intervention trials through MTurk. Participants, 18 years or older, who drank at least weekly were recruited for four intervention trials (combined sample size, N = 11,107). The same basic recruitment strategy was employed for each trial - invite participants to complete a survey about alcohol consumption (less than 15 min in length, US$1.50 payment), identify eligible participants who drank in a hazardous fashion, invite those eligible to complete a follow-up survey ($10 payment), randomize participants to be sent or not sent information to access an online intervention for hazardous alcohol use. Procedures where put in place to optimize the chances that participants could only complete the baseline survey once. There was a substantially slower rate of recruitment by the fourth trial compared to the earlier trials. Demographic characteristics also varied across trials (age, sex, employment and marital status). Patterns of alcohol consumption, while displaying some differences, did not appear to vary in a linear fashion between trials. It is possible to recruit large (but not inexhaustible) numbers of people who drink in a hazardous fashion. Issues for online intervention research when employing this sample are discussed.
Full Text Available Abstract Background Family members are often required to act as substitute decision-makers when health care or research participation decisions must be made for an incapacitated relative. Yet most families are unable to accurately predict older adult preferences regarding future health care and willingness to engage in research studies. Discussion and documentation of preferences could improve proxies' abilities to decide for their loved ones. This trial assesses the efficacy of an advance planning intervention in improving the accuracy of substitute decision-making and increasing the frequency of documented preferences for health care and research. It also investigates the financial impact on the healthcare system of improving substitute decision-making. Methods/Design Dyads (n = 240 comprising an older adult and his/her self-selected proxy are randomly allocated to the experimental or control group, after stratification for type of designated proxy and self-report of prior documentation of healthcare preferences. At baseline, clinical and research vignettes are used to elicit older adult preferences and assess the ability of their proxy to predict those preferences. Responses are elicited under four health states, ranging from the subject's current health state to severe dementia. For each state, we estimated the public costs of the healthcare services that would typically be provided to a patient under these scenarios. Experimental dyads are visited at home, twice, by a specially trained facilitator who communicates the dyad-specific results of the concordance assessment, helps older adults convey their wishes to their proxies, and offers assistance in completing a guide entitled My Preferences that we designed specifically for that purpose. In between these meetings, experimental dyads attend a group information session about My Preferences. Control dyads attend three monthly workshops aimed at promoting healthy behaviors. Concordance
Jones, Roy; Wilkinson, David; Lopez, Oscar L
Large clinical trials databases, developed over the course of a comprehensive clinical trial programme, represent an invaluable resource for clinical researchers. Data mining projects sponsored by industry that use these databases, however, are often not viewed favourably in the academic medical...... community because of concerns that commercial, rather than scientific, goals are the primary purpose of such endeavours. Thus, there are few examples of sustained collaboration between leading academic clinical researchers and industry professionals in a large-scale data mining project. We present here...
Afolabi, Muhammed Olanrewaju; McGrath, Nuala; D'Alessandro, Umberto; Kampmann, Beate; Imoukhuede, Egeruan B; Ravinetto, Raffaella M; Alexander, Neal; Larson, Heidi J; Chandramohan, Daniel; Bojang, Kalifa
To assess the effectiveness of a multimedia informed consent tool for adults participating in a clinical trial in the Gambia. Adults eligible for inclusion in a malaria treatment trial (n = 311) were randomized to receive information needed for informed consent using either a multimedia tool (intervention arm) or a standard procedure (control arm). A computerized, audio questionnaire was used to assess participants' comprehension of informed consent. This was done immediately after consent had been obtained (at day 0) and at subsequent follow-up visits (days 7, 14, 21 and 28). The acceptability and ease of use of the multimedia tool were assessed in focus groups. On day 0, the median comprehension score in the intervention arm was 64% compared with 40% in the control arm (P = 0.042). The difference remained significant at all follow-up visits. Poorer comprehension was independently associated with female sex (odds ratio, OR: 0.29; 95% confidence interval, CI: 0.12-0.70) and residing in Jahaly rather than Basse province (OR: 0.33; 95% CI: 0.13-0.82). There was no significant independent association with educational level. The risk that a participant's comprehension score would drop to half of the initial value was lower in the intervention arm (hazard ratio 0.22, 95% CI: 0.16-0.31). Overall, 70% (42/60) of focus group participants from the intervention arm found the multimedia tool clear and easy to understand. A multimedia informed consent tool significantly improved comprehension and retention of consent information by research participants with low levels of literacy.
... Fishery Management Council (Council); Work Session To Review Proposed Salmon Methodology Changes AGENCY.... ACTION: Notice of a public meeting. SUMMARY: The Pacific Fishery Management Council's Salmon Technical Team (STT), Scientific and Statistical Committee (SSC) Salmon Subcommittee, and Model Evaluation...
The Japan experience during thirty years in nuclear fusion research is reported, after attending the 1st Geneva Conference in 1955, Osaka University, immedeately began linear pinch study using capacitor bank discharge. Subsequently to his trial several groups were organized to ward fusion R and D at universities in Tokyo, Nagoya, Kyoto, Sendai and son on. Based upon the recommendation of Japan Science Council, Institut of Plasma Physics (IPP) was established at Nagoya University in 1961 When the 1st International Conference on Plasma Physics and Controlled Nuclear Fusion Research was held in Saltzburg. The gloomy Bohm barrier had stood in front of many of experiments at that time. (author) [pt
Full Text Available Patient and public involvement (PPI is advocated in clinical trials yet evidence on how to optimise its impact is limited. We explored researchers' and PPI contributors' accounts of the impact of PPI within trials and factors likely to influence its impact.Semi-structured qualitative interviews with researchers and PPI contributors accessed through a cohort of randomised clinical trials. Analysis of transcripts of audio-recorded interviews was informed by the principles of the constant comparative method, elements of content analysis and informant triangulation.We interviewed 21 chief investigators, 10 trial managers and 17 PPI contributors from 28 trials. The accounts of informants within the same trials were largely in agreement. Over half the informants indicted PPI had made a difference within a trial, through contributions that influenced either an aspect of a trial, or how researchers thought about a trial. According to informants, the opportunity for PPI to make a difference was influenced by two main factors: whether chief investigators had goals and plans for PPI and the quality of the relationship between the research team and the PPI contributors. Early involvement of PPI contributors and including them in responsive (e.g. advisory groups and managerial (e.g. trial management groups roles were more likely to achieve impact compared to late involvement and oversight roles (e.g. trial steering committees.Those seeking to enhance PPI in trials should develop goals for PPI at an early stage that fits the needs of the trial, plan PPI implementation in accordance with these goals, invest in developing good relationships between PPI contributors and researchers, and favour responsive and managerial roles for contributors in preference to oversight-only roles. These features could be used by research funders in judging PPI in trial grant applications and to inform policies to optimise PPI within trials.
Vote Elections to fill all seats in the Staff Council are being organized this month. Voting will begin on Monday 31 October. Make your voice heard and be many to elect the new Staff Council. By doing so, you will be encouraging the men and women who will represent you over the next two years and they will doubtless appreciate your gratitude. More details on the elections can be found on the Staff Association web site. (http://association.web.cern.ch) Elections Timetable Monday 31 October, at noon start date for voting Monday 14 November, at noon closing date for voting Monday 21 November, publication of the results in Echo Tuesday 22 and Wednesday 29 November Staff Association Assizes Tuesday 6 December, at 10.00 a.m. first meeting of the new Staff Council and election of the new Executive Committee The voting procedure is monitored by the Election Committee.
Full Text Available Democracy depends on the participation of citizens. Citizenship educationis taking place in classroom communities to prepare pupils for their role ascitizens. Class councils are participatory forms of citizenship educationguaranteeing the children’s right to form and express their views freely aswritten down in the Convention on the Rights of the Child. Theoreticaldeficiencies and empirical objections have been formulated againstparticipation in the school setting. Despite widespread practices, empiricaldata about class councils in Switzerland barely exists. In our researchproject we video-recorded fourteen class councils in secondary schools, weinterviewed the teacher and four pupils of each class, and all the pupilsfilled in a standardized questionnaire. Class councils are very popular formsof education with pupils although the actual power to influence decisions bydeliberation is doubted to some extent. Quantitative analysis of the videorecordingsshows the wide range of forms of class councils that exist inrespect to the talking time of the pupils. To express one’s own viewpointand to understand the standpoint of other discussants, constructarguments and counterarguments, participate, and lead discussions aredifficult tasks. Based on the empirical research the project describes threeforms of class councils that differ in the degree of favouring thedevelopment of communicative competences as a part of citizenshipeducation.
This article was based on the results of research concerning health policy in municipalities that achieved the most extensive development of decentralization and innovation in the State of Rio de Janeiro, Brazil. The study applied a questionnaire for health system users' representatives in Municipal Health Councils. The central issues were: the Councils' political role; social control by the Councils, viewed as surveillance by organized society over government actions; the nature of social representation exercised by the Council members; and the type of mandate they serve. Community representatives in the Councils reinforce aspects pertaining to the exercise of representation in unequal societies. There is a predominance of a differentiated elite consisting of older males with more schooling and higher income than the community average. The notion of "social control" as the basis for the Councils is difficult for the members to grasp. Exercise of representation is diffuse, occurring by way of designation by community associations, election in assemblies, or designation by institutional health policy agencies.
into oil. Large feed lots in which cattle can be concentrated are expected to reduce beef costs significantly, but have not yet been constructed...second on Chemical Feed - stocks. By telephone it was agreed by the Steering Committee that small studies would be held on these topics. Hawthorne...relation to mechanical property characterization of fracture, creep , etc. Our purpose is to explore two related areas: I. Institutional Aspects of
... Evaluation; Advisory Council on Alzheimer's Research, Care, and Services AGENCY: Office of the Assistant... establishment of the Advisory Council on Alzheimer's Research, Care, and Services and request for nominations. SUMMARY: The National Alzheimer's Project Act, Public Law 111-375 (42 U.S.C. 11225), requires that the...
Bicknell, Helen; Knudsen, Herman Lyhne
The paper brings together recent research carried out by the two authors on German and Danish representatives and representation systems within the context of European Works Councils (EWCs).......The paper brings together recent research carried out by the two authors on German and Danish representatives and representation systems within the context of European Works Councils (EWCs)....
Full Text Available ... Health Topics / About Clinical Trials About Clinical Trials Clinical trials are research studies that explore whether a medical strategy, treatment, ... tool for advancing medical knowledge and patient care. Clinical research is done only if doctors don't know ...
Cooper, Stephen A; Desjardins, Paul J; Turk, Dennis C
This article summarizes the results of a meeting convened by the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT) on key considerations and best practices governing the design of acute pain clinical trials. We discuss the role of early phase clinical trials......, including pharmacokinetic-pharmacodynamic (PK-PD) trials, and the value of including both placebo and active standards of comparison in acute pain trials. This article focuses on single-dose and short-duration trials with emphasis on the perioperative and study design factors that influence assay...... sensitivity. Recommendations are presented on assessment measures, study designs, and operational factors. Although most of the methodological advances have come from studies of postoperative pain after dental impaction, bunionectomy, and other surgeries, the design considerations discussed are applicable...
Full Text Available Introduction: The burden of cervical cancer is large and growing in developing countries, due in large part to limited access to screening services and lack of human papillomavirus (HPV vaccination. In spite of modern advances in diagnostic and therapeutic modalities, outcomes from cervical cancer have not markedly improved in recent years. Novel clinical trials are urgently needed to improve outcomes from cervical cancer worldwide. Methods: The Cervix Cancer Research Network (CCRN, a subsidiary of the Gynecologic Cancer InterGroup (GCIG, is a multi-national, multi-institutional consortium of physicians and scientists focused on improving cervical cancer outcomes worldwide by making cancer clinical trials available in low-, middle-, and high-income countries. Standard operating procedures for participation in CCRN include a pre-qualifying questionnaire to evaluate clinical activities and research infrastructure, followed by a site visit. Once a site is approved, they may choose to participate in one of four currently accruing clinical trials.Results: To date, 13 different CCRN site visits have been performed. Of these 13 sites visited, 10 have been approved as CCRN sites including Tata Memorial Hospital, India; Bangalore, India; Trivandrum, India; Ramathibodi, Thailand; Siriaj, Thailand; Pramongkutklao, Thailand; Ho Chi Minh, Vietnam; Blokhin Russian Cancer Research Center; the Hertzen Moscow Cancer Research Institute; and the Russian Scientific Center of Roentgenoradiology. The four currently accruing clinical trials are TACO, OUTBACK, INTERLACE, and SHAPE.Discussion: The CCRN has successfully enrolled 10 sites in developing countries to participate in four randomized clinical trials. The primary objectives are to provide novel therapeutics to regions with the greatest need and to improve the validity and generalizability of clinical trial results by enrolling a diverse sample of patients.
Helen M Kirkby
Full Text Available OBJECTIVES: To assess: 1 the feasibility of electronic information provision; 2 gather evidence on the topics and level of detail of information potential research participant's accessed; 3 to assess satisfaction and understanding. DESIGN: Observational study with an embedded randomised controlled trial. SETTING: Low risk intervention study based in primary care. PARTICIPANTS: White British & Irish, South Asian and African-Caribbean subjects aged between 40-74 years eligible for a blood pressure monitoring study. INTERVENTIONS: PDF copy of the standard paper participant information sheet (PDF-PIS and an electronic Interactive Information Sheet (IIS where participants could choose both the type and level of detail accessed. MAIN OUTCOME MEASURES: 1 Proportion of participants providing an email address and accessing electronic information 2 Willingness to participate in a recruitment clinic. 3 Type and depth of information accessed on the IIS. 4 Participant satisfaction and understanding. RESULTS: 1160 participants were eligible for the study. Of these, 276 (24% provided an active email address, of whom 84 did not respond to the email. 106 responded to the email but chose not to access any electronic information and were therefore ineligible for randomisation. 42 were randomised to receive the PDF-PIS and 44 to receive the IIS (with consent rates of 48% and 36%, respectively; odds ratio 0.6, 95% confidence interval 0.25 to 1.4. Electronic observation of information accessed by potential participants showed 41% chose to access no information and only 9% accessed the detail presented on the Research Ethics Committee approved participant information sheet before booking to attend a recruitment clinic for the intervention study. 63 of the 106 participants (59% who chose not to access any electronic information also booked an appointment. CONCLUSIONS: Current written information about research may not be read, emphasising the importance of the consent
... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ix MaryAnn Foote Clinical trial registries and publication of results - a primer . . . . . . . . . . . . . . . . . . 1 Ana Marušić and Charlotte Haug The journal...
... NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [12-069] NASA Advisory Council; Commercial Space.... DATES: Tuesday, September 18, 2012, 11:45 a.m.-5:30 p.m.; Local Time. ADDRESSES: NASA Ames Research Center (ARC), The Showroom, Building M-3, NASA Ames Conference Center, 500 Severyns Road, NASA Research...
Kowal-Bielecka, O.; Landewé, R.; Avouac, J.; Chwiesko, S.; Miniati, I.; Czirjak, L.; Clements, P.; Denton, C.; Farge, D.; Fligelstone, K.; Földvari, I.; Furst, D. E.; Müller-Ladner, U.; Seibold, J.; Silver, R. M.; Takehara, K.; Toth, B. Garay; Tyndall, A.; Valentini, G.; van den Hoogen, F.; Wigley, F.; Zulian, F.; Matucci-Cerinic, Marco
The optimal treatment of systemic sclerosis (SSc) is a challenge because the pathogenesis of SSc is unclear and it is an uncommon and clinically heterogeneous disease affecting multiple organ systems. The aim of the European League Against Rheumatism (EULAR) Scleroderma Trials and Research group
Brunoni, André R; Tadini, Laura; Fregni, Felipe
There have been many changes in clinical trials methodology since the introduction of lithium and the beginning of the modern era of psychopharmacology in 1949. The nature and importance of these changes have not been fully addressed to date. As methodological flaws in trials can lead to false-negative or false-positive results, the objective of our study was to evaluate the impact of methodological changes in psychopharmacology clinical research over the past 60 years. We performed a systematic review from 1949 to 2009 on MEDLINE and Web of Science electronic databases, and a hand search of high impact journals on studies of seven major drugs (chlorpromazine, clozapine, risperidone, lithium, fluoxetine and lamotrigine). All controlled studies published 100 months after the first trial were included. Ninety-one studies met our inclusion criteria. We analyzed the major changes in abstract reporting, study design, participants' assessment and enrollment, methodology and statistical analysis. Our results showed that the methodology of psychiatric clinical trials changed substantially, with quality gains in abstract reporting, results reporting, and statistical methodology. Recent trials use more informed consent, periods of washout, intention-to-treat approach and parametric tests. Placebo use remains high and unchanged over time. Clinical trial quality of psychopharmacological studies has changed significantly in most of the aspects we analyzed. There was significant improvement in quality reporting and internal validity. These changes have increased study efficiency; however, there is room for improvement in some aspects such as rating scales, diagnostic criteria and better trial reporting. Therefore, despite the advancements observed, there are still several areas that can be improved in psychopharmacology clinical trials.
André R Brunoni
Full Text Available There have been many changes in clinical trials methodology since the introduction of lithium and the beginning of the modern era of psychopharmacology in 1949. The nature and importance of these changes have not been fully addressed to date. As methodological flaws in trials can lead to false-negative or false-positive results, the objective of our study was to evaluate the impact of methodological changes in psychopharmacology clinical research over the past 60 years.We performed a systematic review from 1949 to 2009 on MEDLINE and Web of Science electronic databases, and a hand search of high impact journals on studies of seven major drugs (chlorpromazine, clozapine, risperidone, lithium, fluoxetine and lamotrigine. All controlled studies published 100 months after the first trial were included. Ninety-one studies met our inclusion criteria. We analyzed the major changes in abstract reporting, study design, participants' assessment and enrollment, methodology and statistical analysis. Our results showed that the methodology of psychiatric clinical trials changed substantially, with quality gains in abstract reporting, results reporting, and statistical methodology. Recent trials use more informed consent, periods of washout, intention-to-treat approach and parametric tests. Placebo use remains high and unchanged over time.Clinical trial quality of psychopharmacological studies has changed significantly in most of the aspects we analyzed. There was significant improvement in quality reporting and internal validity. These changes have increased study efficiency; however, there is room for improvement in some aspects such as rating scales, diagnostic criteria and better trial reporting. Therefore, despite the advancements observed, there are still several areas that can be improved in psychopharmacology clinical trials.
Full Text Available Abstract Background Factors associated with the loss of participants in long-term longitudinal studies of ageing, due to refusal or moves, have been discussed less than those with short term follow-up. Methods In a population-based study of cognition and ageing (the Medical Research Council Cognitive Function and Ageing Study (MRC CFAS, factors associated with dropout due to refusal and moving in the first follow-up period (over two years are compared with factors associated with dropout over ten years. Participants at 10-year follow-up are compared with their age-standardised baseline contemporaries. Results Some consistent trends are found over the longer term. Refusers tended to have poorer cognition, less years of education, not have a family history of dementia and be women. Characteristics of people who moved differed between waves, but the oldest and people in worse health moved more. When surviving and responding individuals at ten years are compared with those of the same age at baseline many differences are found. Individuals of lower social class, education, cognitive ability, in residential care, with sight/hearing problems and poor/fair self-reported health are less likely to be seen after 10 years of follow-up. Individuals report more health problems when they participate in multiple interviews. Conclusion The characteristics of refusers in the longer term are similar to those refusing to participate over the shorter term. Long-term follow-up studies will under represent the disadvantaged and disabled but represent full health status of participating individuals better. There are advantages and disadvantages to both short-term and long-term follow-up.
Luncheon hosted by the Director-General for members of the State Council of Geneva: From left to right A. Naudi; J. May; M. Carlo Lamprecht, State Council - Employement, Foreign Office and Economic Departement; M. Robert Hensler, State Chancellor; L. Maiani, CERN Director General; H.F. Hoffmann; M. Robert Cramer, State Council - Environment, Agriculture and Interior Departement; J.Van Der Boon; M. Laurent Moutinot, State Council - Installation, equipment and housing Departement; C. Détraz; C. Wyss; P. Jenni; G. Hentsch; M. Pierre-François Unger, State Council - Health and Social Action Departement; G. Stassinakis; M. Bourquin, CERN Council President.
Full Text Available ... medical knowledge and practice. Why Clinical Trials Are Important Clinical trials are a key research tool for ... other for moderate persistent asthma. The results provided important treatment information for doctors and patients. The results ...
Full Text Available ... Working at the NHLBI Contact and FAQs Accessible Search Form Search the NHLBI, use the drop down list to ... to learn more about clinical research and to search for clinical trials: NHLBI Clinical Trials Browse a ...
Full Text Available ... to main content U.S. Department of Health & Human ... of people. Clinical trials produce the best data available for health care decisionmaking. The purpose of clinical trials is research, ...
Full Text Available ... risks that outweigh any possible benefits. Clinical Trial Phases Clinical trials of new medicines or medical devices are done in phases. These phases have different purposes and help researchers ...
Full Text Available ... the past, clinical trial participants often were White men. Researchers assumed that trial results were valid for ... different ethnic groups sometimes respond differently than White men to the same medical approach. As a result, ...
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L. Gnan; D. Montemerlo; M. Huse
The main objective of this paper is to explore the role of family councils vis-à-vis corporate governance mechanisms. Particularly, the paper explores whether family councils perform only their distinctive family governance role or if they also substitute for the roles performed by corporate governance control mechanisms. Based on a sample of 243 Italian family SMEs, our research findings show that the family council partially substitutes the shareholders' meeting and the board of directors i...
The proceedings contain an outline only of the paper presented at the conference, but major points are distinguishable. The discussion included a summary of major programs, government action programs, public relations and the education program, research and development programs, and challenges of the future
Ouseph, Stacy; Tappitake, Darah; Armant, Myriam; Wesselschmidt, Robin; Derecho, Ivy; Draxler, Rebecca; Wood, Deborah; Centanni, John M
A clinical research roadmap has been developed as a resource for researchers to identify critical areas and potential pitfalls when transitioning a cellular therapy product from the research laboratory, by means of an Investigational New Drug (IND) application, into early-phase clinical trials. The roadmap describes four key areas: basic and preclinical research, resource development, translational research and Good Manufacturing Practice (GMP) and IND assembly and submission. Basic and preclinical research identifies a new therapeutic concept and demonstrates its potential value with the use of a model of the relevant disease. During resource development, the appropriate specialists and the required expertise to bring this product into the clinic are identified (eg, researchers, regulatory specialists, GMP manufacturing staff, clinicians and clinical trials staff, etc). Additionally, the funds required to achieve this goal (or a plan to procure them) are identified. In the next phase, the plan to translate the research product into a clinical-grade therapeutic is developed. Finally regulatory approval to start the trial must be obtained. In the United States, this is done by filing an IND application with the Food and Drug Administration. The National Heart, Lung and Blood Institute-funded Production Assistance for Cellular Therapies program has facilitated the transition of a variety of cellular therapy products from the laboratory into Phase1/2 trials. The five Production Assistance for Cellular Therapies facilities have assisted investigators by performing translational studies and GMP manufacturing to ensure that cellular products met release specifications and were manufactured safely, reproducibly and at the appropriate scale. The roadmap resulting from this experience is the focus of this article. Copyright © 2015 International Society for Cellular Therapy. Published by Elsevier Inc. All rights reserved.
Ingegnoli, Francesca; Ardoino, Ilaria; Boracchi, Patrizia; Cutolo, Maurizio
The aims of this study were to obtain cross-sectional data on capillaroscopy in an international multi-center cohort of Systemic Sclerosis (SSc) and to investigate the frequency of the capillaroscopic patterns and their disease-phenotype associations. Data collected between June 2004 and October 2011 in the EULAR Scleroderma Trials and Research (EUSTAR) registry were examined. Patients' profiles based on clinical and laboratory data were obtained by cluster analysis and the association between profiles and capillaroscopy was investigated by multinomial logistic regression. 62 of the 110 EUSTAR centers entered data on capillaroscopy in the EUSTAR database. 376 of the 2754 patients (13.65%) were classified as scleroderma pattern absent, but non-specific capillary abnormalities were noted in 55.48% of the cases. Four major patients' profiles were identified characterized by a progressive severity for skin involvement, as well as an increased number of systemic manifestations. The "early" and "active" scleroderma patterns were generally observed in patients with mild/moderate skin involvement and a low number of disease manifestations, while the "late" scleroderma pattern was found more frequently in the more severe forms of the disease. These data indicate the importance of capillaroscopy in SSc management and that capillaroscopic patterns are directly related to the extent of organ involvement. Copyright © 2013 Elsevier Inc. All rights reserved.
Gewandter, Jennifer S; Dworkin, Robert H; Turk, Dennis C
Proof-of-concept (POC) clinical trials play an important role in developing novel treatments and determining whether existing treatments may be efficacious in broader populations of patients. The goal of most POC trials is to determine whether a treatment is likely to be efficacious for a given i...
Strode, Ann; Slack, Catherine; Mushariwa, Muriel
An effective ethical-legal framework for the conduct of research is critical. We describe five essential components of such a system, review the extent to which these components have been realised in South Africa, present brief implications for the ethical conduct of clinical trials of HIV vaccines in South Africa and make recommendations. The components of an effective ethical-legal system that we propose are the existence of scientific ethical and policy-making structures that regulate research; research ethics committees (RECs) that ethically review research; national ethical guidelines and standards; laws protecting research participants; and mechanisms to enforce and monitor legal rights and ethical standards. We conclude that the ethical-legal framework has, for the most part, the necessary institutions, and certain necessary guidelines but does not have many of the laws needed to protect and promote the rights of persons participating in research, including HIV vaccine trials. Recommendations made include advocacy measures to finalise and implement legislation, development of regulations, analysis and comparison of ethical guidelines, and the development of measures to monitor ethical-legal rights at trial sites.
Borschmann, Rohan; Patterson, Sue; Poovendran, Dilkushi; Wilson, Danielle; Weaver, Tim
Recruitment to trials is complex and often protracted; selection bias may compromise generalisability. In the mental health field (as elsewhere), diverse factors have been described as hindering researcher access to potential participants and various strategies have been proposed to overcome barriers. However, the extent to which various influences identified in the literature are operational across mental health settings in England has not been systematically examined. A cross-sectional, online survey of clinical studies officers employed by the Mental Health Research Network in England to recruit to trials from National Health Service mental health services. The bespoke questionnaire invited participants to report exposure to specified influences on recruitment, the perceived impact of these on access to potential participants, and to describe additional positive or negative influences on recruitment. Analysis employed descriptive statistics, the framework approach and triangulation of data. Questionnaires were returned by 98 (58%) of 170 clinical studies officers who reported diverse experience. Data demonstrated a disjunction between policy and practice. While the particulars of trial design and various marketing and communication strategies could influence recruitment, consensus was that the culture of NHS mental health services is not conducive to research. Since financial rewards for recruitment paid to Trusts and feedback about studies seldom reaching frontline services, clinicians were described as distanced from research. Facing continual service change and demanding clinical workloads, clinicians generally did not prioritise recruitment activities. Incentives to trial participants had variable impact on access but recruitment could be enhanced by engagement of senior investigators and integrating referral with routine practice. Comprehensive, robust feasibility studies and reciprocity between researchers and clinicians were considered crucial to
Geršl, A.; Jašová, M.; Zápal, Jan
Roč. 64, č. 3 (2014), s. 190-212 ISSN 0015-1920 Grant - others:UK(CZ) UNCE 204005/2012 Institutional support: PRVOUK-P23 Keywords : dynamic inconsistency * fiscal and monetary policy interaction * independent fiscal council Subject RIV: AH - Economic s Impact factor: 0.420, year: 2014 http://journal.fsv.cuni.cz/storage/1298_jasova.pdf
This has been a busy week for the CERN Council, and there is much to report. Firstly, I’m pleased to say that Council approved the Organization’s Medium Term Plan, and with it the budget for financial year 2010. In a time of global recession, this is a strong vote of confidence from the Member States. This meeting of Council provided an opportunity for the working group on the scientific and geographical enlargement of CERN to set out a roadmap towards its final report, which is to be made at Council’s December session this year. One part of the process over the coming months is to bring the major players in particle physics from beyond the European region into the discussion, ensuring that the working group’s recommendations lead to an optimum position for CERN and European particle physics in the global context. An indicator of the continuing attractiveness of CERN is the fact that Council has received four new applications...
With the unveiling of its new sign, the CERN Control Centre was officially inaugurated on Thursday 16 March. To celebrate its startup, CERN Council members visited the sleek centre, a futuristic-looking room filled with a multitude of monitoring screens.
Huang, Chun-Ping; Lin, Tzung-Yi; Chiao, Ling-Huan; Chen, Hong-Bin
Highlights: ► Deal with a practical radioactive contamination in Taiwan Research Reactor spent fuel pool water. ► Identify the properties of radioactive contaminants and performance test for water treatment materials. ► The radioactive solids were primary attributed by ruptured spent fuels, spent resins, and metal debris. ► The radioactive ions were major composed by uranium and fission products. ► Diatomite-based ceramic depth filter can simultaneously removal radioactive solids and ions. - Abstract: There were approximately 926 m 3 of water contaminated by fission products and actinides in the Taiwan Research Reactor's spent fuel pool (TRR SFP). The solid and ionic contaminants were thoroughly characterized using radiochemical analyses, scanning electron microscopy equipped with an energy dispersive spectrometer (SEM-EDS), and inductively coupled plasma optical emission spectrometry (ICP-OES) in this study. The sludge was made up of agglomerates contaminated by spent fuel particles. Suspended solids from spent ion-exchange resins interfered with the clarity of the water. In addition, the ionic radionuclides such as 137 Cs, 90 Sr, U, and α-emitters, present in the water were measured. Various filters and cation-exchange resins were employed for water treatment trials, and the results indicated that the solid and ionic contaminants could be effectively removed through the use of <0.9 μm filters and cation exchange resins, respectively. Interestingly, the removal of U was obviously efficient by cation exchange resin, and the ceramic depth filter composed of diatomite exhibited the properties of both filtration and adsorption. It was found that the ceramic depth filter could adsorb β-emitters, α-emitters, and uranium ions. The diatomite-based ceramic depth filter was able to simultaneously eliminate particles and adsorb ionic radionuclides from water.
Torres, Samantha; de la Riva, Erika E; Tom, Laura S; Clayman, Marla L; Taylor, Chirisse; Dong, Xinqi; Simon, Melissa A
Despite increasing need to boost the recruitment of underrepresented populations into cancer trials and biobanking research, few tools exist for facilitating dialogue between researchers and potential research participants during the recruitment process. In this paper, we describe the initial processes of a user-centered design cycle to develop a standardized research communication tool prototype for enhancing research literacy among individuals from underrepresented populations considering enrollment in cancer research and biobanking studies. We present qualitative feedback and recommendations on the prototype's design and content from potential end users: five clinical trial recruiters and ten potential research participants recruited from an academic medical center. Participants were given the prototype (a set of laminated cards) and were asked to provide feedback about the tool's content, design elements, and word choices during semi-structured, in-person interviews. Results suggest that the prototype was well received by recruiters and patients alike. They favored the simplicity, lay language, and layout of the cards. They also noted areas for improvement, leading to card refinements that included the following: addressing additional topic areas, clarifying research processes, increasing the number of diverse images, and using alternative word choices. Our process for refining user interfaces and iterating content in early phases of design may inform future efforts to develop tools for use in clinical research or biobanking studies to increase research literacy.
Kagan, Jonathan; Giang, Dao Duc; Iademarco, Michael F; Phung, Van Tt; Lau, Chuen-Yen; Quang, Nguyen Ngo
Although improving health systems promises important benefits, most developing nations lack the resources to support nationally driven clinical research. Strengthened clinical research capacity can advance national health goals by supporting greater autonomy in aligning research with national priorities. From March through June 2010, we assessed six elements of clinical research capacity in Vietnam: research agenda; clinical investigators and biostatisticians; donors and sponsors; community involvement; scientific, ethical, safety, and quality oversight; and clinical research institutions. Assessments were drawn from interviews with investigators, Ministry of Health staff members, nongovernment organizations, and U.S. Mission staff members, and document review. Observations and recommendations were shared with collaborators. Reassessment in 2015 found growth in the number of clinical trials, improved regulation in human subjects protection and community engagement, and modest advances in research agenda setting. Training and investment in institutions remain challenging. A framework for assessing clinical research capacity can affirm strengths and weaknesses and guide the coordination of capacity-building efforts.
... SMALL BUSINESS ADMINISTRATION National Women's Business Council AGENCY: U.S. Small Business... Business Council (NWBC). The meeting will be open to the public. DATES: The meeting will be held on October... [[Page 61467
... Month NCADD National Council on Alcoholism and Drug Dependence Addiction is a Disease - Treatment is Available - Recovery ... years, The National Council on Alcoholism and Drug Dependence, Inc. (NCADD) has been a valuable resource for ...
Mentoring Children of Incarcerated Parents: A Synthesis of Research and Input from the Listening Session Held by the Office of Juvenile Justice and Delinquency Prevention and the White House Domestic Policy Council and Office of Public Engagement
Jarjoura, G. Roger; DuBois, David L.; Shlafer, Rebecca J.; Haight, Konrad A.
In September 2013, a Listening Session on Mentoring Children of Incarcerated Parents was held in Washington, DC. This session was organized by the U.S. Department of Justice's Office of Juvenile Justice and Delinquency Prevention in partnership with the White House Domestic Policy Council and Office of Public Engagement. It continues the…
The coming years will be dominated by the building of LEP and the preparation for the four approved experiments. Construction of the underground ring tunnel to house the electron-positron collider will begin very soon and about half of the contracts for machine components have been placed. The four experiments, ALEPH, DELPHI, L3 and OPAL have been designed and costed in detail. Over 900 physicists are involved and contracts with the participating research centres are being drawn up specifying responsibilities and financial commitments. Thus the whole timescale and expenditure profile of the LEP project is now much clearer
John A. Cunningham
Full Text Available Abstract Background Mechanical Turk (MTurk is an online portal operated by Amazon where ‘requesters’ (individuals or businesses can submit jobs for ‘workers.’ MTurk is used extensively by academics as a quick and cheap means of collecting questionnaire data, including information on alcohol consumption, from a diverse sample of participants. We tested the feasibility of recruiting for alcohol Internet intervention trials through MTurk. Methods Participants, 18 years or older, who drank at least weekly were recruited for four intervention trials (combined sample size, N = 11,107. The same basic recruitment strategy was employed for each trial – invite participants to complete a survey about alcohol consumption (less than 15 min in length, US$1.50 payment, identify eligible participants who drank in a hazardous fashion, invite those eligible to complete a follow-up survey ($10 payment, randomize participants to be sent or not sent information to access an online intervention for hazardous alcohol use. Procedures where put in place to optimize the chances that participants could only complete the baseline survey once. Results There was a substantially slower rate of recruitment by the fourth trial compared to the earlier trials. Demographic characteristics also varied across trials (age, sex, employment and marital status. Patterns of alcohol consumption, while displaying some differences, did not appear to vary in a linear fashion between trials. Conclusions It is possible to recruit large (but not inexhaustible numbers of people who drink in a hazardous fashion. Issues for online intervention research when employing this sample are discussed.
Burns, Karen E A; Devlin, John W; Hill, Nicholas S
The call for meaningful patient and family engagement in research has recently gained considerable momentum. This article defines patient and family engagement broadly and specifically in clinical research. Using a multicenter, North American weaning trial as an exemplar, we describe our early experiences as clinical researchers with patient and family engagement. The role of our Patient and Family Advisory Committee in trial design and implementation is illustrated. Through our experiences, we share our insights regarding the perceived opportunities and also highlight some challenges associated with engaging patients and family engagement in critical care research. Although "engagement science" is in its infancy, engaging patients and families in research holds promise as a novel research paradigm that will not only provide new insights into the questions, methods, and outcomes used in ICU research, but it will also make investments in research more accountable and ensure a strong "patient- and family-centered focus" of our research. Copyright © 2017 American College of Chest Physicians. Published by Elsevier Inc. All rights reserved.
Mahantshetti Niranjana S
Full Text Available Abstract Background This randomized controlled trial aims to evaluate the effects of an early developmental intervention program on the development of young children in low- and low-middle-income countries who are at risk for neurodevelopmental disability because of birth asphyxia. A group of children without perinatal complications are evaluated in the same protocol to compare the effects of early developmental intervention in healthy infants in the same communities. Birth asphyxia is the leading specific cause of neonatal mortality in low- and low-middle-income countries and is also the main cause of neonatal and long-term morbidity including mental retardation, cerebral palsy, and other neurodevelopmental disorders. Mortality and morbidity from birth asphyxia disproportionately affect more infants in low- and low-middle-income countries, particularly those from the lowest socioeconomic groups. There is evidence that relatively inexpensive programs of early developmental intervention, delivered during home visit by parent trainers, are capable of improving neurodevelopment in infants following brain insult due to birth asphyxia. Methods/Design This trial is a block-randomized controlled trial that has enrolled 174 children with birth asphyxia and 257 without perinatal complications, comparing early developmental intervention plus health and safety counseling to the control intervention receiving health and safety counseling only, in sites in India, Pakistan, and Zambia. The interventions are delivered in home visits every two weeks by parent trainers from 2 weeks after birth until age 36 months. The primary outcome of the trial is cognitive development, and secondary outcomes include social-emotional and motor development. Child, parent, and family characteristics and number of home visits completed are evaluated as moderating factors. Discussion The trial is supervised by a trial steering committee, and an independent data monitoring
De Las Nueces, Denise; Hacker, Karen; DiGirolamo, Ann; Hicks, LeRoi S
Objective To examine the effectiveness of current community-based participatory research (CBPR) clinical trials involving racial and ethnic minorities. Data Source All published peer-reviewed CBPR intervention articles in PubMed and CINAHL databases from January 2003 to May 2010. Study Design We performed a systematic literature review. Data Collection/Extraction Methods Data were extracted on each study's characteristics, community involvement in research, subject recruitment and retention, and intervention effects. Principle Findings We found 19 articles meeting inclusion criteria. Of these, 14 were published from 2007 to 2010. Articles described some measures of community participation in research with great variability. Although CBPR trials examined a wide range of behavioral and clinical outcomes, such trials had very high success rates in recruiting and retaining minority participants and achieving significant intervention effects. Conclusions Significant publication gaps remain between CBPR and other interventional research methods. CBPR may be effective in increasing participation of racial and ethnic minority subjects in research and may be a powerful tool in testing the generalizability of effective interventions among these populations. CBPR holds promise as an approach that may contribute greatly to the study of health care delivery to disadvantaged populations. PMID:22353031
Ramsey, Scott D; Willke, Richard J; Glick, Henry; Reed, Shelby D; Augustovski, Federico; Jonsson, Bengt; Briggs, Andrew; Sullivan, Sean D
Clinical trials evaluating medicines, medical devices, and procedures now commonly assess the economic value of these interventions. The growing number of prospective clinical/economic trials reflects both widespread interest in economic information for new technologies and the regulatory and reimbursement requirements of many countries that now consider evidence of economic value along with clinical efficacy. As decision makers increasingly demand evidence of economic value for health care interventions, conducting high-quality economic analyses alongside clinical studies is desirable because they broaden the scope of information available on a particular intervention, and can efficiently provide timely information with high internal and, when designed and analyzed properly, reasonable external validity. In 2005, ISPOR published the Good Research Practices for Cost-Effectiveness Analysis Alongside Clinical Trials: The ISPOR RCT-CEA Task Force report. ISPOR initiated an update of the report in 2014 to include the methodological developments over the last 9 years. This report provides updated recommendations reflecting advances in several areas related to trial design, selecting data elements, database design and management, analysis, and reporting of results. Task force members note that trials should be designed to evaluate effectiveness (rather than efficacy) when possible, should include clinical outcome measures, and should obtain health resource use and health state utilities directly from study subjects. Collection of economic data should be fully integrated into the study. An incremental analysis should be conducted with an intention-to-treat approach, complemented by relevant subgroup analyses. Uncertainty should be characterized. Articles should adhere to established standards for reporting results of cost-effectiveness analyses. Economic studies alongside trials are complementary to other evaluations (e.g., modeling studies) as information for decision
Direskeneli, Haner; Aydin, Sibel Z; Kermani, Tanaz A; Matteson, Eric L; Boers, Maarten; Herlyn, Karen; Luqmani, Raashid A; Neogi, Tuhina; Seo, Philip; Suppiah, Ravi; Tomasson, Gunnar; Merkel, Peter A
Giant cell (GCA) and Takayasu's arteritis (TAK) are 2 forms of large-vessel vasculitis (LVV) that involve the aorta and its major branches. GCA has a predilection for the cranial branches, while TAK tends to affect the extracranial branches. Both disorders may also cause nonspecific constitutional symptoms. Although some clinical features are more common in one or the other disorder and the ages of initial presentation differ substantially, there is enough clinical and histopathologic overlap between these disorders that some investigators suggest GCA and TAK may be 2 processes within the spectrum of a single disease. There have been few randomized therapeutic trials completed in GCA, and none in TAK. The lack of therapeutic trials in LVV is only partially explained by the rarity of these diseases. It is likely that the lack of well validated outcome measures for LVV and uncertainties regarding trial design contribute to the paucity of trials for these diseases. An initiative to develop a core set of outcome measures for use in clinical trials of LVV was launched by the international OMERACT Vasculitis Working Group in 2009 and subsequently endorsed by the OMERACT community at the OMERACT 10 meeting. Aims of this initiative include: (1) to review the literature and existing data related to outcome assessments in LVV; (2) to obtain the opinion of experts and patients on disease content; and (3) to formulate a research agenda to facilitate a more data-based approach to outcomes development.
... SMALL BUSINESS ADMINISTRATION National Women's Business Council AGENCY: U.S. Small Business... Business Council (NWBC). The meeting will be open to the public. DATES: The meeting will be held on Monday...., Appendix 2), SBA announces the meeting of the National Women's Business Council. The National Women's...
State Employees Governor's Council on Disabilities and Special Education DHSS State of Alaska Home ; Governor's Council on Disabilities and Special Education Page Content Untitled Document Patrick Reinhart : follow GCDSE to 40404 The Governor's Council on Disabilities & Special Education is pleased to award
Lewis, Wayne D.; Bjork, Lars G.; Zhao, Yuru; Chi, Bin
This exploratory study examines how schools in Beijing have responded to a Chinese national policy mandate to establish and maintain parent councils. We surveyed principals and parent council members across schools in the Beijing municipality about the establishment and functions of their schools' parent councils. Survey results provide insights…
... 36 Parks, Forests, and Public Property 3 2010-07-01 2010-07-01 false Council comments. 801.4 Section 801.4 Parks, Forests, and Public Property ADVISORY COUNCIL ON HISTORIC PRESERVATION HISTORIC PRESERVATION REQUIREMENTS OF THE URBAN DEVELOPMENT ACTION GRANT PROGRAM § 801.4 Council comments. The following...
... DEPARTMENT OF ENERGY National Coal Council AGENCY: Department of Energy. ACTION: Notice of open meeting. SUMMARY: This notice announces a meeting of the National Coal Council (NCC). The Federal Advisory... Biomass/Coal Blending to Generate Electricity Council Business: [cir] Finance Report by Committee Chairman...
... DEPARTMENT OF ENERGY National Coal Council AGENCY: Office of Fossil Energy, Department of Energy..., notice is hereby given that the National Coal Council will be renewed for a two-year period beginning... general policy matters relating to coal issues. Additionally, the renewal of the Council has been...
... DEPARTMENT OF ENERGY National Coal Council AGENCY: Department of Energy. ACTION: Notice of open meeting. SUMMARY: This notice announces a meeting of the National Coal Council (NCC). The Federal Advisory... 2013 meeting of the National Coal Council. Agenda: 1. Opening Remarks by NCC Chairman John Eaves 2...
... DEPARTMENT OF ENERGY National Coal Council AGENCY: Department of Energy, Office of Fossil Energy..., notice is hereby given that the National Coal Council (NCC) will be renewed for a two-year period. The... matters relating to coal issues. Additionally, the renewal of the National Coal Council has been...
... DEPARTMENT OF ENERGY National Coal Council AGENCY: Department of Energy. ACTION: Notice of open meetings. SUMMARY: This notice announces two meetings of the National Coal Council (NCC). The Federal...: Agenda for Thursday, May 16, 2013 1. Call to Order by John Eaves, Chairman, National Coal Council 2...
... DEPARTMENT OF ENERGY National Petroleum Council AGENCY: Office of Fossil Energy, Department of... Petroleum Council. The Federal Advisory Committee Act (Pub. L. 92-463, 86 Stat. 770) requires that public... Administrative Matters Discussion of Any Other Business Properly Brought Before the National Petroleum Council...
... DEPARTMENT OF ENERGY National Petroleum Council AGENCY: Department of Energy, Office of Fossil... National Petroleum Council. The Federal Advisory Committee Act (Pub. L. 92-463, 86 Stat. 770) requires that... Matters Discussion of Any Other Business Properly Brought Before the National Petroleum Council...
... DEPARTMENT OF ENERGY National Petroleum Council AGENCY: Department of Energy, Office of Fossil... Petroleum Council. The Federal Advisory Committee Act (Pub. L. 92-463, 86 Stat. 770) requires that public... Properly Brought Before the National, Petroleum Council, Adjournment. Public Participation: The meeting is...
French, Helen P; Cusack, Tara; Brennan, Aisling; Caffrey, Aoife; Conroy, Ronán; Cuddy, Vanessa; FitzGerald, Oliver M; Fitzpatrick, Martina; Gilsenan, Clare; Kane, David; O'Connell, Paul G; White, Breon; McCarthy, Geraldine M
To determine the effectiveness of exercise therapy (ET) compared with ET with adjunctive manual therapy (MT) for people with hip osteoarthritis (OA); and to identify if immediate commencement of treatment (ET or ET+MT) was more beneficial than a 9-week waiting period for either intervention. Assessor-blind randomized controlled trial with a 9-week and 18-week follow-up. Four academic teaching hospitals in Dublin, Ireland. Patients (N=131) with hip OA recruited from general practitioners, rheumatologists, orthopedic surgeons, and other hospital consultants were randomized to 1 of 3 groups: ET (n=45), ET+MT (n=43), and waitlist controls (n=43). Participants in both the ET and ET+MT groups received up to 8 treatments over 8 weeks. Control group participants were rerandomized into either ET or ET+MT groups after 9 week follow-up. Their data were pooled with original treatment group data: ET (n=66) and ET+MT (n=65). The primary outcome was the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) physical function (PF) subscale. Secondary outcomes included physical performance, pain severity, hip range of motion (ROM), anxiety/depression, quality of life, medication usage, patient-perceived change, and patient satisfaction. There was no significant difference in WOMAC PF between the ET (n=66) and ET+MT (n=65) groups at 9 weeks (mean difference, .09; 95% confidence interval [CI] -2.93 to 3.11) or 18 weeks (mean difference, .42; 95% CI, -4.41 to 5.25), or between other outcomes, except patient satisfaction with outcomes, which was higher in the ET+MT group (P=.02). Improvements in WOMAC, hip ROM, and patient-perceived change occurred in both treatment groups compared with the control group. Self-reported function, hip ROM, and patient-perceived improvement occurred after an 8-week program of ET for patients with OA of the hip. MT as an adjunct to exercise provided no further benefit, except for higher patient satisfaction with outcome. Copyright © 2013
French, Helen P
OBJECTIVE: To determine the effectiveness of exercise therapy (ET) compared to ET with adjunctive manual therapy (ET+MT) for people with hip osteoarthritis (OA). A secondary aim was to identify if immediate commencement of ET or ET+MT was more beneficial than a 9 week waiting period for either intervention. DESIGN: Assessor-blind randomised controlled trial with 9 and 18 week follow-ups. SETTING: Four academic teaching hospitals, Dublin, Ireland. PARTICIPANTS: 131 patients with hip OA recruited from general practitioners, rheumatologists, orthopaedic surgeons, and other hospital consultants were randomised to one of three groups: ET (n=45), ET+MT (n=43) and wait-list control (n=43). INTERVENTIONS: Participants in both ET and ET+ MT groups received up to 8 treatments over 8 weeks. Control group participants were re-randomised into either ET or ET+MT group after 9 week follow-up. Their data were pooled with original treatment group data: ET (n=66) and ET+MT (n=65). MAIN OUTCOME MEASURES: The primary outcome was the WOMAC physical function (PF) subscale. Secondary outcomes included physical performance, pain, hip range of motion (HROM), anxiety\\/depression, quality of life, medication usage, patient-perceived change and patient satisfaction. RESULTS: There was no significant difference in WOMAC PF between ET (n=66) and ET+MT (n=65) groups at 9 weeks (mean diff 0.09 (95% CI -4.41, 5.25)) or at 18 weeks (mean diff 0.42 (95% CI -3.98, 6.83)), or other outcomes, except \\'patient satisfaction with outcome\\' which was higher in the ET+MT group (p=0.02). Improvements in WOMAC, HROM and patient-perceived change occurred in both treatment groups compared with the control group. CONCLUSION: Self-reported function, HROM and patient-perceived improvement occurred after an 8 week programme of ET for patients with hip OA MT as an adjunct provided no further benefit, except for higher patient satisfaction.
Khorsan, Raheleh; Coulter, Ian D.; Crawford, Cindy; Hsiao, An-Fu
A systematic review was conducted to assess the level of evidence for integrative health care research. We searched PubMed, Allied and Complementary Medicine (AMED), BIOSIS Previews, EMBASE, the entire Cochrane Library, MANTIS, Social SciSearch, SciSearch Cited Ref Sci, PsychInfo, CINAHL, and NCCAM grantee publications listings, from database inception to May 2009, as well as searches of the “gray literature.” Available studies published in English language were included. Three independent re...
... meeting. SUMMARY: The Gulf of Mexico Fishery Management Council will convene a public meeting via webinar... meeting will be held via webinar. Council address: Gulf of Mexico Fishery Management Council, 2203 North... Executive Director, Gulf of Mexico Fishery Management Council; telephone: (813) 348-1630. SUPPLEMENTARY...
... Ranger District; Idaho; Mill Creek--Council Mountain Landscape Restoration Project AGENCY: Forest Service... the Mill Creek--Council Mountain Landscape Restoration Project. The approximate 51,900 acre project area is located about two miles east of Council, Idaho. The Mill Creek--Council Mountain Landscape...
A combined analysis of European Organization for Research and Treatment of Cancer, and Medical Research Council randomized clinical trials for the prophylactic treatment of stage TaT1 bladder cancer. European Organization for Research and Treatment of Cancer Genitourinary Tract Cancer Cooperative Group and the Medical Research Council Working Party on Superficial Bladder Cancer
Pawinski, A.; Sylvester, R.; Kurth, K. H.; Bouffioux, C.; van der Meijden, A.; Parmar, M. K.; Bijnens, L.
The use of prophylactic agents after primary resection can decrease the incidence of tumor recurrence in patients with stage TaT1 bladder cancer. However, the long-term impact on progression to muscle invasive disease as well as on duration of survival is unknown. A combined analysis of individual
Tussing-Humphreys, Lisa; Lamar, Melissa; Blumenthal, James A; Babyak, Michael; Fantuzzi, Giamila; Blumstein, Lara; Schiffer, Linda; Fitzgibbon, Marian L
Obesity has been linked to cognitive impairment, cognitive decline and dementia. Given that 38.5% of U.S. adults 60years and older are obese and these numbers are rapidly increasing, strategies to decouple obesity from cognitive decline are needed. Innovative lifestyle strategies that may postpone the onset of subclinical symptoms or even arrest the transition to overt dementia in at-risk individuals are critically needed. Poor diet is central to the development of obesity and diet may affect cognition. Adherence to a Mediterranean Diet (MedDiet) is associated with reduced risk of cognitive impairment and dementia. Furthermore, weight loss through caloric restriction improves cognitive function. This paper describes the Building Research in Diet and CoGnition (BRIDGE) study, a randomized trial examining the effect of the MedDiet, with and without weight loss, on cognitive functioning in obese older adults. Obese (BMI≥30 and ≤50kg/m 2 ) older adults (≥55years) (n=180) will be randomized in a 2:2:1 allocation scheme to: Typical Diet Control; MedDiet alone, without weight loss; or MedDiet lifestyle intervention to promote weight loss and weight loss maintenance. Both MedDiet intervention groups will meet for one individual session and 27 group sessions over an 8-month period. Individuals in the control group will not receive instruction on changing lifestyle habits. Outcomes will be assessed at baseline, 8 and 14months. The primary outcome is cognitive functioning; secondary outcomes will include changes in body weight, diet, cardiovascular, metabolic, and inflammatory biomarkers. Copyright © 2017. Published by Elsevier Inc.
Wang, Yuanjia; Garcia, Tanya P; Ma, Yanyuan
This work presents methods for estimating genotype-specific distributions from genetic epidemiology studies where the event times are subject to right censoring, the genotypes are not directly observed, and the data arise from a mixture of scientifically meaningful subpopulations. Examples of such studies include kin-cohort studies and quantitative trait locus (QTL) studies. Current methods for analyzing censored mixture data include two types of nonparametric maximum likelihood estimators (NPMLEs) which do not make parametric assumptions on the genotype-specific density functions. Although both NPMLEs are commonly used, we show that one is inefficient and the other inconsistent. To overcome these deficiencies, we propose three classes of consistent nonparametric estimators which do not assume parametric density models and are easy to implement. They are based on the inverse probability weighting (IPW), augmented IPW (AIPW), and nonparametric imputation (IMP). The AIPW achieves the efficiency bound without additional modeling assumptions. Extensive simulation experiments demonstrate satisfactory performance of these estimators even when the data are heavily censored. We apply these estimators to the Cooperative Huntington's Observational Research Trial (COHORT), and provide age-specific estimates of the effect of mutation in the Huntington gene on mortality using a sample of family members. The close approximation of the estimated non-carrier survival rates to that of the U.S. population indicates small ascertainment bias in the COHORT family sample. Our analyses underscore an elevated risk of death in Huntington gene mutation carriers compared to non-carriers for a wide age range, and suggest that the mutation equally affects survival rates in both genders. The estimated survival rates are useful in genetic counseling for providing guidelines on interpreting the risk of death associated with a positive genetic testing, and in facilitating future subjects at risk
Wallander, Jan L; McClure, Elizabeth; Biasini, Fred; Goudar, Shivaprasad S; Pasha, Omrana; Chomba, Elwyn; Shearer, Darlene; Wright, Linda; Thorsten, Vanessa; Chakraborty, Hrishikesh; Dhaded, Sangappa M; Mahantshetti, Niranjana S; Bellad, Roopa M; Abbasi, Zahid; Carlo, Waldemar
This randomized controlled trial aims to evaluate the effects of an early developmental intervention program on the development of young children in low- and low-middle-income countries who are at risk for neurodevelopmental disability because of birth asphyxia. A group of children without perinatal complications are evaluated in the same protocol to compare the effects of early developmental intervention in healthy infants in the same communities. Birth asphyxia is the leading specific cause of neonatal mortality in low- and low-middle-income countries and is also the main cause of neonatal and long-term morbidity including mental retardation, cerebral palsy, and other neurodevelopmental disorders. Mortality and morbidity from birth asphyxia disproportionately affect more infants in low- and low-middle-income countries, particularly those from the lowest socioeconomic groups. There is evidence that relatively inexpensive programs of early developmental intervention, delivered during home visit by parent trainers, are capable of improving neurodevelopment in infants following brain insult due to birth asphyxia. This trial is a block-randomized controlled trial that has enrolled 174 children with birth asphyxia and 257 without perinatal complications, comparing early developmental intervention plus health and safety counseling to the control intervention receiving health and safety counseling only, in sites in India, Pakistan, and Zambia. The interventions are delivered in home visits every two weeks by parent trainers from 2 weeks after birth until age 36 months. The primary outcome of the trial is cognitive development, and secondary outcomes include social-emotional and motor development. Child, parent, and family characteristics and number of home visits completed are evaluated as moderating factors. The trial is supervised by a trial steering committee, and an independent data monitoring committee monitors the trial. Findings from this trial have the potential
Full Text Available Abstract Background Microinsurance or Community-Based Health Insurance is a promising healthcare financing mechanism, which is increasingly applied to aid rural poor persons in low-income countries. Robust empirical evidence on the causal relations between Community-Based Health Insurance and healthcare utilisation, financial protection and other areas is scarce and necessary. This paper contains a discussion of the research design of three Cluster Randomised Controlled Trials in India to measure the impact of Community-Based Health Insurance on several outcomes. Methods/Design Each trial sets up a Community-Based Health Insurance scheme among a group of micro-finance affiliate families. Villages are grouped into clusters which are congruous with pre-existing social groupings. These clusters are randomly assigned to one of three waves of implementation, ensuring the entire population is offered Community-Based Health Insurance by the end of the experiment. Each wave of treatment is preceded by a round of mixed methods evaluation, with quantitative, qualitative and spatial evidence on impact collected. Improving upon practices in published Cluster Randomised Controlled Trial literature, we detail how research design decisions have ensured that both the households offered insurance and the implementers of the Community-Based Health Insurance scheme operate in an environment replicating a non-experimental implementation. Discussion When a Cluster Randomised Controlled Trial involves randomizing within a community, generating adequate and valid conclusions requires that the research design must be made congruous with social structures within the target population, to ensure that such trials are conducted in an implementing environment which is a suitable analogue to that of a non-experimental implementing environment.
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Avram, Robert; Marquis-Gravel, Guillaume; Simard, François; Pacheco, Christine; Couture, Étienne; Tremblay-Gravel, Maxime; Desplantie, Olivier; Malhamé, Isabelle; Bibas, Lior; Mansour, Samer; Parent, Marie-Claude; Farand, Paul; Harvey, Luc; Lessard, Marie-Gabrielle; Ly, Hung; Liu, Geoffrey; Hay, Annette E; Marc Jolicoeur, E
Use of health administrative databases is proposed for screening and monitoring of participants in randomized registry trials. However, access to these databases raises privacy concerns. We assessed patient's preferences regarding use of personal information to link their research records with national health databases, as part of a hypothetical randomized registry trial. Cardiology patients were invited to complete an anonymous self-reported survey that ascertained preferences related to the concept of accessing government health databases for research, the type of personal identifiers to be shared and the type of follow-up preferred as participants in a hypothetical trial. A total of 590 responders completed the survey (90% response rate), the majority of which were Caucasians (90.4%), male (70.0%) with a median age of 65years (interquartile range, 8). The majority responders (80.3%) would grant researchers access to health administrative databases for screening and follow-up. To this end, responders endorsed the recording of their personal identifiers by researchers for future record linkage, including their name (90%), and health insurance number (83.9%), but fewer responders agreed with the recording of their social security number (61.4%, pgranting researchers access to the administrative databases (OR: 1.69, 95% confidence interval: 1.03-2.90; p=0.04). The majority of Cardiology patients surveyed were supportive of use of their personal identifiers to access administrative health databases and conduct long-term monitoring in the context of a randomized registry trial. Copyright © 2018 Elsevier Ireland Ltd. All rights reserved.
Full Text Available ... clinical trials are required to have an IRB. Office for Human Research Protections The U.S. Department of Health and Human Services’ (HHS’) Office for Human Research Protections (OHRP) oversees all research ...