Social and behavioral research in genomic sequencing: approaches from the Clinical Sequencing Exploratory Research Consortium Outcomes and Measures Working Group.

PubMed

Gray, Stacy W; Martins, Yolanda; Feuerman, Lindsay Z; Bernhardt, Barbara A; Biesecker, Barbara B; Christensen, Kurt D; Joffe, Steven; Rini, Christine; Veenstra, David; McGuire, Amy L

2014-10-01

The routine use of genomic sequencing in clinical medicine has the potential to dramatically alter patient care and medical outcomes. To fully understand the psychosocial and behavioral impact of sequencing integration into clinical practice, it is imperative that we identify the factors that influence sequencing-related decision making and patient outcomes. In an effort to develop a collaborative and conceptually grounded approach to studying sequencing adoption, members of the National Human Genome Research Institute's Clinical Sequencing Exploratory Research Consortium formed the Outcomes and Measures Working Group. Here we highlight the priority areas of investigation and psychosocial and behavioral outcomes identified by the Working Group. We also review some of the anticipated challenges to measurement in social and behavioral research related to genomic sequencing; opportunities for instrument development; and the importance of qualitative, quantitative, and mixed-method approaches. This work represents the early, shared efforts of multiple research teams as we strive to understand individuals' experiences with genomic sequencing. The resulting body of knowledge will guide recommendations for the optimal use of sequencing in clinical practice.

The effect of federal funding on clinical productivity: the price of academics.

PubMed

McKenney, Mark M; Livingstone, Alan S; Schulman, Carl

2011-01-01

Research is time consuming and expensive. To offset this expense, federal agencies fund the research, but the financial impact of funded research on clinical surgical productivity has not been studied. The objective is to determine departmental impact of federal funding. The relative value units, professional revenue, and funding were evaluated for clinical Faculty in the Surgery Department for fiscal year 2008. Means were compared using t test, and significance was defined as p<0.05. The Department had 61 clinical surgeons. The Department was divided into three groups based on research funding: unfunded, industry funded, and federally funded. Surgeons with both federal funding and other funding were only included in the federally funded group. There were 42 unfunded, 8 industry funded, and 11 federally funded surgeons. The relative value units, professional revenue, and salary with benefits of the three groups were compared. Federal funding is associated with a significant reduction in clinical work and clinical reimbursement. Federally funded research results in a net loss of revenue for the Surgery Department. The net effect is that the Surgery Department sponsors Federal Research and this has not been previously reported in the literature.

The Rules of Engagement: CTTI Recommendations for Successful Collaborations Between Sponsors and Patient Groups Around Clinical Trials.

PubMed

Bloom, Diane; Beetsch, Joel; Harker, Matthew; Hesterlee, Sharon; Moreira, Paulo; Patrick-Lake, Bray; Selig, Wendy; Sherman, Jeffrey; Smith, Sophia K; Valentine, James E; Roberts, Jamie N

2018-03-01

To identify the elements necessary for successful collaboration between patient groups and academic and industry sponsors of clinical trials, in order to develop recommendations for best practices for effective patient group engagement. In-depth interviews, informed by a previously reported survey, were conducted to identify the fundamentals of successful patient group engagement. Thirty-two respondents from 3 sectors participated: patient groups, academic researchers, and industry. The findings were presented to a multistakeholder group of experts in January 2015. The expert group came to consensus on a set of actionable recommendations for best practices for patient groups and research sponsors. Interview respondents acknowledged that not all patient groups are created equal in terms of what they can contribute to a clinical trial. The most important elements for effective patient group engagement include establishing meaningful partnerships, demonstrating mutual benefits, and collaborating as partners from the planning stage forward. Although there is a growing appreciation by sponsors about the benefits of patient group engagement, there remains some resistance and some uncertainty about how best to engage. Barriers include mismatched expectations and a perception that patient groups lack scientific sophistication and that "wishful thinking" may cloud their recommendations. Patient groups are developing diverse skillsets and acquiring assets to leverage in order to become collaborators with industry and academia on clinical trials. Growing numbers of research sponsors across the clinical trials enterprise are recognizing the benefits of continuous and meaningful patient group engagement, but there are still mindsets to change, and stakeholders need further guidance on operationalizing a new model of clinical trial conduct.

Clinical trial participation. Viewpoints from racial/ethnic groups.

PubMed

Roberson, N L

1994-11-01

Racial/ethnic groups' participation in clinical trials is a relatively new area of research that warrants attention. Although racial/ethnic groups have been included in experimental studies since the 1940s, they were not included in significant numbers in clinical trials for cancer. Clinical trials play a dominant role in clinical oncology. Despite this state-of-the-art cancer treatment, however, there is mounting concern that this scientific progress is not being shared equitably by all segments of the U.S. population. There is underrepresentation of members of racial/ethnic groups in cancer clinical trials, which suggests that participation may be a critical issue. Unfortunately, little is known or documented about these groups' participation in clinical trials. This paper discusses racial/ethnic groups' views and opinions about clinical trial participation. Diagnostic research was conducted as a beginning phase to investigate this new area of research. African Americans, Hispanics, and Native Americans in three Buffalo, New York, communities were selected as study subjects. Data were collected via telephone surveys. Qualitative methods were employed for data analysis and reporting. Findings showed that study subjects knew little about cancer clinical trials and basically had no opportunity to participate. They believed that participation in clinical trials could be beneficial. In each of the three groups, however, there were cultural factors believed to influence participation. A primary concern was "mistrust of white people" and the feeling of being treated like "guinea pigs." Based on study findings, it was evident that recruitment for improving participation requires strategic planning that involves participants representative of the study population. To yield results, the plan should be tailored to the target group, presented as a credible study, designed to reflect trust in the medical care team, and implemented through a continuous educational process.

Team building: electronic management-clinical translational research (eM-CTR) systems.

PubMed

Cecchetti, Alfred A; Parmanto, Bambang; Vecchio, Marcella L; Ahmad, Sjarif; Buch, Shama; Zgheib, Nathalie K; Groark, Stephen J; Vemuganti, Anupama; Romkes, Marjorie; Sciurba, Frank; Donahoe, Michael P; Branch, Robert A

2009-12-01

Classical drug exposure: response studies in clinical pharmacology represent the quintessential prototype for Bench to Bedside-Clinical Translational Research. A fundamental premise of this approach is for a multidisciplinary team of researchers to design and execute complex, in-depth mechanistic studies conducted in relatively small groups of subjects. The infrastructure support for this genre of clinical research is not well-handled by scaling down of infrastructure used for large Phase III clinical trials. We describe a novel, integrated strategy, whose focus is to support and manage a study using an Information Hub, Communication Hub, and Data Hub design. This design is illustrated by an application to a series of varied projects sponsored by Special Clinical Centers of Research in chronic obstructive pulmonary disease at the University of Pittsburgh. In contrast to classical informatics support, it is readily scalable to large studies. Our experience suggests the culture consequences of research group self-empowerment is not only economically efficient but transformative to the research process.

The first interview: Anxieties and research on initiating psychoanalysis.

PubMed

Reith, Bernard

2015-06-01

A qualitative clinical study of preliminary interviews by the Working Party on Initiating Psychoanalysis (WPIP) of the European Psychoanalytic Federation suggests that the unconscious dynamics in first interviews are extraordinarily powerful and that they give rise to deep unconscious anxieties in both patient and analyst, with the corresponding defences against them. Furthermore, the group dynamics observed in the clinical workshops and in the research team doing the study suggest that both the anxieties and the defences are conveyed to these groups in the form of unelaborated 'session residues' provoking renewed anxieties and defences in them. These findings contribute to our understanding of what goes on in first interviews, but also raise interesting questions about the psychoanalytic research process in psychoanalysis and how confrontation with the unknown is dealt with in that context. Rather than as a means to avoid anxiety, method in clinical research can be seen as a way to help the research group to contain its reactions and to tolerate them until the group finds its way to further elaboration. These points are illustrated with a clinical case drawn from the study. Copyright © 2014 Institute of Psychoanalysis.

Five-year review of an international clinical research-training program

PubMed Central

Suemoto, Claudia Kimie; Ismail, Sherine; Corrêa, Paulo César Rodrigues Pinto; Khawaja, Faiza; Jerves, Teodoro; Pesantez, Laura; Germani, Ana Claudia Camargo Gonçalves; Zaina, Fabio; dos Santos, Augusto Cesar Soares; de Oliveira Ferreira, Ricardo Jorge; Singh, Priyamvada; Paulo, Judy Vicente; Matsubayashi, Suely Reiko; Vidor, Liliane Pinto; Andretta, Guilherme; Tomás, Rita; Illigens, Ben MW; Fregni, Felipe

2015-01-01

The exponential increase in clinical research has profoundly changed medical sciences. Evidence that has accumulated in the past three decades from clinical trials has led to the proposal that clinical care should not be based solely on clinical expertise and patient values, and should integrate robust data from systematic research. As a consequence, clinical research has become more complex and methods have become more rigorous, and evidence is usually not easily translated into clinical practice. Therefore, the instruction of clinical research methods for scientists and clinicians must adapt to this new reality. To address this challenge, a global distance-learning clinical research-training program was developed, based on collaborative learning, the pedagogical goal of which was to develop critical thinking skills in clinical research. We describe and analyze the challenges and possible solutions of this course after 5 years of experience (2008–2012) with this program. Through evaluation by students and faculty, we identified and reviewed the following challenges of our program: 1) student engagement and motivation, 2) impact of heterogeneous audience on learning, 3) learning in large groups, 4) enhancing group learning, 5) enhancing social presence, 6) dropouts, 7) quality control, and 8) course management. We discuss these issues and potential alternatives with regard to our research and background. PMID:25878518

Five-year review of an international clinical research-training program.

PubMed

Suemoto, Claudia Kimie; Ismail, Sherine; Corrêa, Paulo César Rodrigues Pinto; Khawaja, Faiza; Jerves, Teodoro; Pesantez, Laura; Germani, Ana Claudia Camargo Gonçalves; Zaina, Fabio; Dos Santos, Augusto Cesar Soares; de Oliveira Ferreira, Ricardo Jorge; Singh, Priyamvada; Paulo, Judy Vicente; Matsubayashi, Suely Reiko; Vidor, Liliane Pinto; Andretta, Guilherme; Tomás, Rita; Illigens, Ben Mw; Fregni, Felipe

2015-01-01

The exponential increase in clinical research has profoundly changed medical sciences. Evidence that has accumulated in the past three decades from clinical trials has led to the proposal that clinical care should not be based solely on clinical expertise and patient values, and should integrate robust data from systematic research. As a consequence, clinical research has become more complex and methods have become more rigorous, and evidence is usually not easily translated into clinical practice. Therefore, the instruction of clinical research methods for scientists and clinicians must adapt to this new reality. To address this challenge, a global distance-learning clinical research-training program was developed, based on collaborative learning, the pedagogical goal of which was to develop critical thinking skills in clinical research. We describe and analyze the challenges and possible solutions of this course after 5 years of experience (2008-2012) with this program. Through evaluation by students and faculty, we identified and reviewed the following challenges of our program: 1) student engagement and motivation, 2) impact of heterogeneous audience on learning, 3) learning in large groups, 4) enhancing group learning, 5) enhancing social presence, 6) dropouts, 7) quality control, and 8) course management. We discuss these issues and potential alternatives with regard to our research and background.

Complex contexts and relationships affect clinical decisions in group therapy.

PubMed

Tasca, Giorgio A; Mcquaid, Nancy; Balfour, Louise

2016-09-01

Clinical errors tend to be underreported even though examining them can provide important training and professional development opportunities. The group therapy context may be prone to clinician errors because of the added complexity within which therapists work and patients receive treatment. We discuss clinical errors that occurred within a group therapy in which a patient for whom group was not appropriate was admitted to the treatment and then was not removed by the clinicians. This was countertherapeutic for both patient and group. Two clinicians were involved: a clinical supervisor who initially assessed and admitted the patient to the group, and a group therapist. To complicate matters, the group therapy occurred within the context of a clinical research trial. The errors, possible solutions, and recommendations are discussed within Reason's Organizational Accident Model (Reason, 2000). In particular, we discuss clinician errors in the context of countertransference and clinician heuristics, group therapy as a local work condition that complicates clinical decision-making, and the impact of the research context as a latent organizational factor. We also present clinical vignettes from the pregroup preparation, group therapy, and supervision. Group therapists are more likely to avoid errors in clinical decisions if they engage in reflective practice about their internal experiences and about the impact of the context in which they work. Therapists must keep in mind the various levels of group functioning, especially related to the group-as-a-whole (i.e., group composition, cohesion, group climate, and safety) when making complex clinical decisions in order to optimize patient outcomes. (PsycINFO Database Record (c) 2016 APA, all rights reserved).

The feasibility, perceived satisfaction, and value of using synchronous webinars to educate clinical research professionals on reporting adverse events in clinical trials: a report from the Children's Oncology Group.

PubMed

Borgerson, Dawn; Dino, Jennifer

2012-01-01

Clinical research professionals are faced with decreased funding and increased workloads; innovative methods of professional development programs are necessary to accommodate these factors. This study evaluated the feasibility, perceived satisfaction, and value of using webinars to educate clinical research professionals on reporting adverse events commonly experienced in pediatric oncology clinical trials. The setting incorporated synchronous web-based educational technology. Constructivist learning provides the theoretical framework for this study. Participants evaluated the professional development program at 2 time points: (a) at the conclusion and (b) 4 to 6 weeks afterward, using survey method. Synchronous webinars were both economical and effective in educating clinical research professionals across institutional sites. Participants reported exceptionally high levels of satisfaction with the accessibility, scope, quality, and interactivity of the professional development program. The vast majority of participants reported that the education would assist with reporting adverse events in pediatric oncology clinical trials and this perception persisted into clinical practice. Although the results of this study were intended to guide future educational efforts of the Children's Oncology Group, they may also apply to other cooperative groups.

Antibacterial resistance leadership group: open for business.

PubMed

Chambers, Henry F; Bartlett, John G; Bonomo, Robert A; Chiou, Christine; Cosgrove, Sara E; Cross, Heather R; Daum, Robert S; Downing, Michele; Evans, Scott R; Knisely, Jane; Kreiswirth, Barry N; Lautenbach, Ebbing; Mickley, Brenda S; Patel, Robin; Pettigrew, Melinda M; Rodvold, Keith A; Spellberg, Brad; Fowler, Vance G

2014-06-01

Funded by the National Institute of Allergy and Infectious Diseases, the Antibacterial Resistance Leadership Group (ARLG) is tasked with developing a clinical research agenda and conducting clinical studies to address the growing public health threat of antibacterial resistance. The ARLG has identified 4 high-priority areas of research: infections caused by gram-negative bacteria, infections caused by gram-positive bacteria, antimicrobial stewardship and infection prevention, and diagnostics. The ARLG will be accepting proposals from the scientific community for clinical research that addresses 1 or more of these high-priority areas. These studies should have the potential to transform medical practice and be unlikely to occur without ARLG support. The purpose of this article is to make interested parties aware of clinical research opportunities made available by ARLG and to encourage submission of clinical research proposals that address the problem of antibacterial resistance.

Clinical Nurse Specialist Roles in Conducting Research: Changes Over 3 Years.

PubMed

Albert, Nancy M; Rice, Karen L; Waldo, Mary J; Bena, James F; Mayo, Ann M; Morrison, Shannon L; Westlake, Cheryl; Ellstrom, Kathleen; Powers, Jan; Foster, Jan

2016-01-01

The aim of this study is to describe clinical nurse specialists' characteristics, interest, confidence, motivators, and barriers in conducting research. This study was a descriptive, multicohort design. Clinical nurse specialists were recruited electronically through national and local organizations to complete anonymous surveys 3 times, over 3 years. Comparative analyses included χ and Kruskal-Wallis tests. Of 2052 responders (initial, n = 629; 18 months, n = 465; and 3 years, n = 958), mean (SD) participant age was 50.3 (9.3) years. Overall, 41.7% of participants were involved as principal or coinvestigators in research. Interest in conducting nursing research (on a 0-100 scale) was 61.1 (38.4) and was lowest among the 18-month time point participant group (score, 39.1 [32.2]) and highest at the 3-year time point (68.3, [30.7]; P < .001). Confidence in conducting research, discussion of statistics, and perceptions of motivators and barriers to conducting research did not differ across time period groups. Access to literature and mentors and research knowledge were the most prevalent barriers to conducting research. Less than 42% of clinical nurse specialists conducted research and the rate did not change between different time groups. Access and knowledge barriers to conducting research were prominent. Workplace leaders need to consider resources and support of academic educational opportunities to increase research conduct by clinical nurse specialists.

Adherence and retention in clinical trials: a community-based approach.

PubMed

Fouad, Mona N; Johnson, Rhoda E; Nagy, M Christine; Person, Sharina D; Partridge, Edward E

2014-04-01

The Community Health Advisor (CHA) model has been widely used to recruit rural and low-income, mostly African American women into clinical and behavioral research studies. However, little is known about its effectiveness in promoting retention and adherence of such women in clinical trials. The Community-Based Retention Intervention Study evaluated the effectiveness of a community-based intervention strategy using the CHA model and the empowerment theory to improve the retention and adherence of minority and low-income women in clinical trials. The research strategy included the training and use of the volunteer CHAs as research partners. The target population included women participating in the University of Alabama at Birmingham clinical site of the Atypical Squamous Cells of Undetermined Significance-Low-Grade Squamous Intraepithelial Lesion (ASCUS-LSIL) Triage Study (ALTS), a multicenter, randomized clinical trial. Two communities in Jefferson County, Alabama, that were matched according to population demographics were identified and randomly assigned to either an intervention group or a control group. Thirty community volunteers were recruited to be CHAs and to implement the intervention with the ALTS trial participants. In total, 632 ALTS participants agreed to participate in the project, including 359 in the intervention group, which received CHA care, and 273 in the control group, which received standard care. Adherence rates for scheduled clinic visits were significantly higher in the intervention group (80%) compared with the control group (65%; P < .0001). The results indicate that volunteer CHAs can be trained to serve as research partners and can be effective in improving the retention and adherence of minority and low-income women in clinical trials. © 2014 American Cancer Society.

Prioritization in comparative effectiveness research: the CANCERGEN Experience.

PubMed

Thariani, Rahber; Wong, William; Carlson, Josh J; Garrison, Louis; Ramsey, Scott; Deverka, Patricia A; Esmail, Laura; Rangarao, Sneha; Hoban, Carolyn J; Baker, Laurence H; Veenstra, David L

2012-05-01

Systematic approaches to stakeholder-informed research prioritization are a central focus of comparative effectiveness research. Genomic testing in cancer is an ideal area to refine such approaches given rapid innovation and potentially significant impacts on patient outcomes. To develop and pilot test a stakeholder-informed approach to prioritizing genomic tests for future study in collaboration with the cancer clinical trials consortium SWOG. We conducted a landscape analysis to identify genomic tests in oncology using a systematic search of published and unpublished studies, and expert consultation. Clinically valid tests suitable for evaluation in a comparative study were presented to an external stakeholder group. Domains to guide the prioritization process were identified with stakeholder input, and stakeholders ranked tests using multiple voting rounds. A stakeholder group was created including representatives from patient-advocacy groups, payers, test developers, regulators, policy makers, and community-based oncologists. We identified 9 domains for research prioritization with stakeholder feedback: population impact; current standard of care, strength of association; potential clinical benefits, potential clinical harms, economic impacts, evidence of need, trial feasibility, and market factors. The landscape analysis identified 635 studies; of 9 tests deemed to have sufficient clinical validity, 6 were presented to stakeholders. Two tests in lung cancer (ERCC1 and EGFR) and 1 test in breast cancer (CEA/CA15-3/CA27.29) were identified as top research priorities. Use of a diverse stakeholder group to inform research prioritization is feasible in a pragmatic and timely manner. Additional research is needed to optimize search strategies, stakeholder group composition, and integration with existing prioritization mechanisms.

Prioritization in Comparative Effectiveness Research: The CANCERGEN Experience in Cancer Genomics

PubMed Central

Thariani, Rahber; Wong, William; Carlson, Josh J; Garrison, Louis; Ramsey, Scott; Deverka, Patricia A; Esmail, Laura; Rangarao, Sneha; Hoban, Carolyn J; Baker, Laurence H; Veenstra, David L

2012-01-01

Background Systematic approaches to stakeholder-informed research prioritization are a central focus of comparative effectiveness research. Genomic testing in cancer is an ideal area to refine such approaches given rapid innovation and potentially significant impacts on patient outcomes. Objective To develop and pilot-test a stakeholder-informed approach to prioritizing genomic tests for future study in collaboration with the cancer clinical trials consortium SWOG. Methods We conducted a landscape-analysis to identify genomic tests in oncology using a systematic search of published and unpublished studies, and expert consultation. Clinically valid tests suitable for evaluation in a comparative study were presented to an external stakeholder group. Domains to guide the prioritization process were identified with stakeholder input, and stakeholders ranked tests using multiple voting rounds. Results A stakeholder group was created including representatives from patient-advocacy groups, payers, test developers, regulators, policy-makers, and community-based oncologists. We identified nine domains for research prioritization with stakeholder feedback: population impact; current standard of care, strength of association; potential clinical benefits, potential clinical harms, economic impacts, evidence of need, trial feasibility, and market factors. The landscape-analysis identified 635 studies; of 9 tests deemed to have sufficient clinical validity, 6 were presented to stakeholders. Two tests in lung cancer (ERCC1 and EGFR) and one test in breast cancer (CEA/CA15-3/CA27.29) were identified as top research priorities. Conclusions Use of a diverse stakeholder group to inform research prioritization is feasible in a pragmatic and timely manner. Additional research is needed to optimize search strategies, stakeholder group composition and integration with existing prioritization mechanisms. PMID:22274803

An analysis of registered clinical trials in otolaryngology from 2007 to 2010: ClinicalTrials.gov.

PubMed

Witsell, David L; Schulz, Kristine A; Lee, Walter T; Chiswell, Karen

2013-11-01

To describe the conditions studied, interventions used, study characteristics, and funding sources of otolaryngology clinical trials from the ClinicalTrials.gov database; compare this otolaryngology cohort of interventional studies to clinical visits in a health care system; and assess agreement between clinical trials and clinical activity. Database analysis. Trial registration data downloaded from ClinicalTrials.gov and administrative data from the Duke University Medical Center from October 1, 2007 to September 27, 2010. Data extraction from ClinicalTrials.gov was done using MeSH and non-MeSH disease condition terms. Studies were subcategorized to create the following groupings for descriptive analysis: ear, nose, allergy, voice, sleep, head and neck cancer, thyroid, and throat. Duke Health System visits were queried by using selected ICD-9 codes for otolaryngology and non-otolaryngology providers. Visits were grouped similarly to ClinicalTrials.gov for further analysis. Chi-square tests were used to explore differences between groups. A total of 1115 of 40,970 registered interventional trials were assigned to otolaryngology. Head and neck cancer trials predominated. Study models most frequently incorporated parallel design (54.6%), 2 study groups (46.6%), and randomization (69.1%). Phase 2 or 3 studies constituted 46.4% of the cohort. Comparison of the ClinicalTrials.gov database with administrative health system visit data by disease condition showed discordance between national research activity and clinical visit volume for patients with otolaryngology complaints. Analysis of otolaryngology-related clinical research as listed in ClinicalTrials.gov can inform patients, physicians, and policy makers about research focus areas. The relative burden of otolaryngology-associated conditions in our tertiary health system exceeds research activity within the field.

Group functioning of a collaborative family research team.

PubMed

Johnson, S K; Halm, M A; Titler, M G; Craft, M; Kleiber, C; Montgomery, L A; Nicholson, A; Buckwalter, K; Cram, E

1993-07-01

Collaborative research teams are an attractive means of conducting nursing research in the clinical setting because of the many opportunities that collaboration can supply. These opportunities include a chance to: (1) network with other nurses who have similar interests, (2) share knowledge and expertise for designing clinical studies that directly affect daily practice, (3) develop instruments, (4) write grant proposals, (5) collect and analyze data, and (6) prepare manuscripts for publication. The effectiveness of research teams, however, is strongly influenced by group functioning. This article describes the functioning of a collaborative family interventions research team of nursing faculty members and CNSs at a large Midwestern university setting. The formation of the group and membership characteristics are described, along with strategies used to identify the research focus and individual and group goals. Aspects related to the influence of the group on members and the internal operations of the group are also addressed. Future strategies to be explored will focus on the size of the group and joint authorship issues. The authors also set forth a number of recommendations for development of collaborative research groups.

StaR Child Health: developing evidence-based guidance for the design, conduct and reporting of paediatric trials.

PubMed

Van't Hoff, William; Offringa, Martin

2015-02-01

There has been a huge upsurge in clinical research in children in the last decade, stimulated in England by dedicated research infrastructure and support through the National Institute for Health Research. This infrastructure offering research design, expert review, trial management, research nurse, data support and dedicated facilities enables paediatricians to conduct more and better research. The challenge is how to design and conduct trials that will make a real difference to children's health. Standards for Research (StaR) in Child Health was founded in 2009 to address the paucity and shortcomings of paediatric clinical trials. This global initiative involves methodologists, clinicians, patient advocacy groups and policy makers dedicated to developing practical, evidence-based standards for enhancing the reliability and relevance of paediatric clinical research. In this overview, we highlight the contribution of StaR to this agenda, describe the international context, and suggest how StaR's future plans could be integrated with new and existing support for research. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

Towards the development of a comprehensive framework: Qualitative systematic survey of definitions of clinical research quality

PubMed Central

von Niederhäusern, Belinda; Schandelmaier, Stefan; Mi Bonde, Marie; Brunner, Nicole; Hemkens, Lars G.; Rutquist, Marielle; Bhatnagar, Neera; Guyatt, Gordon H.; Pauli-Magnus, Christiane; Briel, Matthias

2017-01-01

Objective To systematically survey existing definitions, concepts, and criteria of clinical research quality, both developed by stakeholder groups as well as in the medical literature. This study serves as a first step in the development of a comprehensive framework for the quality of clinical research. Study design and setting We systematically and in duplicate searched definitions, concepts and criteria of clinical research quality on websites of stakeholders in clinical research until no further insights emerged and in MEDLINE up to February 2015. Stakeholders included governmental bodies, regulatory agencies, the pharmaceutical industry, academic and commercial contract research organizations, initiatives, research ethics committees, patient organizations and funding agencies from 13 countries. Data synthesis involved descriptive and qualitative analyses following the Framework Method on definitions, concepts, and criteria of clinical research quality. Descriptive codes were applied and grouped into clusters to identify common and stakeholder-specific quality themes. Results Stakeholder concepts on how to assure quality throughout study conduct or articles on quality assessment tools were common, generally with no a priori definition of the term quality itself. We identified a total of 20 explicit definitions of clinical research quality including varying quality dimensions and focusing on different stages in the clinical research process. Encountered quality dimensions include ethical conduct, patient safety/rights/priorities, internal validity, precision of results, generalizability or external validity, scientific and societal relevance, transparency and accessibility of information, research infrastructure and sustainability. None of the definitions appeared to be comprehensive either in terms of quality dimensions, research stages, or stakeholder perspectives. Conclusion Clinical research quality is often discussed but rarely defined. A framework defining clinical research quality across stakeholders’ individual perspectives is desirable to facilitate discussion, assessment, and improvement of quality at all stages of clinical research. PMID:28715491

Towards the development of a comprehensive framework: Qualitative systematic survey of definitions of clinical research quality.

PubMed

von Niederhäusern, Belinda; Schandelmaier, Stefan; Mi Bonde, Marie; Brunner, Nicole; Hemkens, Lars G; Rutquist, Marielle; Bhatnagar, Neera; Guyatt, Gordon H; Pauli-Magnus, Christiane; Briel, Matthias

2017-01-01

To systematically survey existing definitions, concepts, and criteria of clinical research quality, both developed by stakeholder groups as well as in the medical literature. This study serves as a first step in the development of a comprehensive framework for the quality of clinical research. We systematically and in duplicate searched definitions, concepts and criteria of clinical research quality on websites of stakeholders in clinical research until no further insights emerged and in MEDLINE up to February 2015. Stakeholders included governmental bodies, regulatory agencies, the pharmaceutical industry, academic and commercial contract research organizations, initiatives, research ethics committees, patient organizations and funding agencies from 13 countries. Data synthesis involved descriptive and qualitative analyses following the Framework Method on definitions, concepts, and criteria of clinical research quality. Descriptive codes were applied and grouped into clusters to identify common and stakeholder-specific quality themes. Stakeholder concepts on how to assure quality throughout study conduct or articles on quality assessment tools were common, generally with no a priori definition of the term quality itself. We identified a total of 20 explicit definitions of clinical research quality including varying quality dimensions and focusing on different stages in the clinical research process. Encountered quality dimensions include ethical conduct, patient safety/rights/priorities, internal validity, precision of results, generalizability or external validity, scientific and societal relevance, transparency and accessibility of information, research infrastructure and sustainability. None of the definitions appeared to be comprehensive either in terms of quality dimensions, research stages, or stakeholder perspectives. Clinical research quality is often discussed but rarely defined. A framework defining clinical research quality across stakeholders' individual perspectives is desirable to facilitate discussion, assessment, and improvement of quality at all stages of clinical research.

Platelet Immunology in China: Research and Clinical Applications.

PubMed

Wu, Guoguang; Zhou, Yan; Li, Lilan; Zhong, Zhoulin; Li, Hengchong; Li, Haiyan; Yu, Mei; Shen, Weidong; Ni, Heyu

2017-04-01

Immunization against human platelet alloantigens (HPAs) is associated with a number of clinical complications. The detection and identification of clinically relevant platelet antibodies are important for the diagnosis and management of patients affected with immune-mediated thrombocytopenias. Human platelet alloantigen frequencies and the characteristics of antiplatelet antibodies vary widely between ethnic groups. Since 2008, the importance of platelet immunology in the field of transfusion medicine has gained greater recognition by clinical laboratories in China. Laboratories in China have established and improved methods for platelet antibody detection and HPA genotyping techniques, which are used for the diagnosis of alloimmune platelet disorders in clinic and research environments. Research has revealed the frequencies of HPA alleles in different Chinese ethnic groups and compared the differences in HPA gene frequencies between the Chinese Han and other ethnic groups of the world. Production of anti-CD36 isoantibodies is an important risk factor for immune-mediated thrombocytopenia in the Chinese population. Advances in research and clinical application of platelet immunology have significantly improved the clinical diagnosis, treatment including transfusion support, and prevention of alloimmune platelet disorders in the Chinese population. Copyright © 2017. Published by Elsevier Inc.

About the Prostate and Urologic Cancer Research Group | Division of Cancer Prevention

Cancer.gov

The Prostate and Urologic Cancer Research Group conducts and supports research on prostate and bladder cancers, and new approaches to clinical prevention studies including cancer immunoprevention. The group develops, implements and monitors research efforts in chemoprevention, nutrition, genetic, and immunologic interventions, screening, early detection and other prevention

The role of analogy-guided learning experiences in enhancing students' clinical decision-making skills.

PubMed

Edelen, Bonnie Gilbert; Bell, Alexandra Alice

2011-08-01

The purpose of this study was to address the need for effective educational interventions to promote students' clinical decision making (CDM) within clinical practice environments. Researchers used a quasi-experimental, non-equivalent groups, posttest-only design to assess differences in CDM ability between intervention group students who participated in analogy-guided learning activities and control group students who participated in traditional activities. For the intervention, analogy-guided learning activities were incorporated into weekly group discussions, reflective journal writing, and questioning with clinical faculty. The researcher-designed Assessment of Clinical Decision Making Rubric was used to assess indicators of CDM ability in all students' reflective journal entries. Results indicated that the intervention group demonstrated significantly higher levels of CDM ability in their journals compared with the control group (ES(sm) = 0.52). Recommendations provide nurse educators with strategies to maximize students' development of CDM ability, better preparing students for the demands they face when they enter the profession. Copyright 2011, SLACK Incorporated.

The Rules of Engagement

PubMed Central

Bloom, Diane; Beetsch, Joel; Harker, Matthew; Hesterlee, Sharon; Moreira, Paulo; Patrick-Lake, Bray; Selig, Wendy; Sherman, Jeffrey; Smith, Sophia K.; Valentine, James E.; Roberts, Jamie N.

2017-01-01

Objective: To identify the elements necessary for successful collaboration between patient groups and academic and industry sponsors of clinical trials, in order to develop recommendations for best practices for effective patient group engagement. Methods: In-depth interviews, informed by a previously reported survey, were conducted to identify the fundamentals of successful patient group engagement. Thirty-two respondents from 3 sectors participated: patient groups, academic researchers, and industry. The findings were presented to a multistakeholder group of experts in January 2015. The expert group came to consensus on a set of actionable recommendations for best practices for patient groups and research sponsors. Results: Interview respondents acknowledged that not all patient groups are created equal in terms of what they can contribute to a clinical trial. The most important elements for effective patient group engagement include establishing meaningful partnerships, demonstrating mutual benefits, and collaborating as partners from the planning stage forward. Although there is a growing appreciation by sponsors about the benefits of patient group engagement, there remains some resistance and some uncertainty about how best to engage. Barriers include mismatched expectations and a perception that patient groups lack scientific sophistication and that “wishful thinking” may cloud their recommendations. Conclusions: Patient groups are developing diverse skillsets and acquiring assets to leverage in order to become collaborators with industry and academia on clinical trials. Growing numbers of research sponsors across the clinical trials enterprise are recognizing the benefits of continuous and meaningful patient group engagement, but there are still mindsets to change, and stakeholders need further guidance on operationalizing a new model of clinical trial conduct. PMID:29714514

Perceptions community residents have about partner institutions and clinical research.

PubMed

Kennedy, Betty M; Katzmarzyk, Peter T; Johnson, William D; Griffin, Willene P; Kennedy, Kathleen B; Cefalu, William T; Ryan, Donna H

2013-12-01

Engaging community residents to obtain their feedback in conducting clinical research, and including them as leaders in implementing applicable health advances is crucial for success and sustaining large center awards. Forty-four adult men and women participated in one of four focus groups. Two groups each (one African American and one Caucasian) were conducted in Baton Rouge and in New Orleans. In an effort to determine the knowledge, attitudes, and beliefs Louisiana residents have about the Louisiana Clinical and Translational Science (LA CaTS) Center concept, four main themes emerged from focus group participants concerning the state's research institutions, and what it means to have these institutions operating under one umbrella to improve the quality of health of its people: (1) academic/research institutions of the State are uniformly widely recognized and held in high regard; (2) increasing awareness of clinical research is a necessity; (3) establishing the LA CaTS Center is an excellent idea; and (4) effective communication including delivery style is crucial to partnerships and especially to the community. Focus group discussions can provide insight into community residents' perceptions, beliefs, motivations, and patterns of behavior for strategically planning for large center awards. © 2013 Wiley Periodicals, Inc.

Innovative strategies for teaching nursing research in Taiwan.

PubMed

Liou, Shwu-Ru; Cheng, Ching-Yu; Tsai, Hsiu-Min; Chang, Chia-Hao

2013-01-01

Evidence-based practice is imperative in clinical settings because it bridges the gap between research findings and clinical practice. Promoting nursing student interest and enthusiasm for research is therefore crucial when teaching nursing research. The aim of thus study was to develop innovative teaching strategies that increase nursing students' interests and engagement in research. This study employed a descriptive, pretest-posttest, quasiexperimental design with 103 participants in the experimental group and 106 in the control group. The Attitudes toward Research Questionnaire, Classroom Engagement Scale, Self-Directed Learning Instrument, Nursing Eight Core Competencies Scale, Value of Teams survey, and a research knowledge test were applied to evaluate the outcomes of the innovative teaching strategies. Scores for the research knowledge test were significantly higher in the experimental group than in the control group in posttest 1 and posttest 2. After the intervention, participants in the experimental group exhibited higher scores on attitudes toward research, eight core competencies in nursing,value of teams, classroom engagement, and self-directed learning than participants in the control group. Students in the experimental group perceived a lower degree of pressure and higher degrees of interest, enjoyment, and acceptance of the research course than students in the control group. This study confirmed that using innovative teaching strategies in nursing research courses enhances student interest and enthusiasm about evidence-based practice.

Clinical Trials in Vision Research

MedlinePlus

... the treatment group . If you are in the control group , you could receive the standard treatment for a ... Researchers randomly assign participants to the treatment and control groups. In most studies, you have an equal chance ...

Current status of registry of vaccine clinical trials conducted by Korean investigators in ClinicalTrials.gov, database of US National Institutes of Health.

PubMed

Cho, Jahyang; Kim, Bo Bae; Bae, Chong-Woo; Cha, Sung-Ho

2013-01-01

PubMed is not only includes international medical journals but also has a registration site for the ongoing clinical trials, such as ClinicalTrials.gov, under the supervision of US National Institutes of Health. We analyzed current status of vaccine clinical trials conducted by Korean investigators in database of ClinicalTrial.gov. As of October 2012, there are total of 72 trials found on registry of vaccine clinical trials conducted by Korean investigators in database of ClinicalTrial.gov. These trials were analyzed and classified by conditions of vaccine clinical trials, biologicals or drugs used in vaccine clinical trials, status of proceeding research, and list of sponsor and collaborators. Total 72 trials of vaccine clinical trials conducted by Korean investigators are classified by groups of infection (64 trials), cancer (4 trials), and others (4 trials). Infections group shown are as follows: poliomyelitis, pertussis, diphtheria, tetanus, and Haemophilus influenzae type b (10), influenza (9), human papillomavirus infection (8), pneumococcal vaccine (6), herpes zoster (4), smallpox (4), hepatitis B (4), etc. One trial of each in lung cancer, breast cancer, prostate cancer, and colorectal cancer are shown in cancer group. One trial of each in Crohn's disease, ulcerative colitis, renal failure, and rheumatoid arthritis are shown in other group. Vaccine clinical trials conducted by Korean investigators in ClinicalTrial.gov reflects the current status of Korean research on vaccine clinical trials at the international level and can indicate research progress. It is hoped that this aids the development of future vaccine clinical trials in Korea.

Opinions of sports clinical practice chiropractors, with sports specialty training and those without, about chiropractic research priorities in sports health care: a centering resonance analysis

PubMed Central

Lee, Alexander D; Szabo, Kaitlyn; McDowell, Kirstie; Granger, Sydney

2016-01-01

Introduction: A Canadian sports chiropractic research agenda has yet to be defined. The Delphi method can be utilized to achieve this purpose; however, the sample of experts who participate can influence the results. To better inform sample selection for future research agenda development, we set out to determine if differences in opinions about research priorities exist between chiropractors who have their sports specialty designation and those who do not. Methods: Fifteen sports clinical practice chiropractors who have their sports fellowship designation and fifteen without, were interviewed with a set of standardized questions about sports chiropractic research priorities. A centering resonance analysis and cluster analysis were conducted on the interview responses. Results: The two practitioner groups differed in their opinions about the type of research that they would like to see conducted, the research that would impact their clinical practice the most, and where they believed research was lacking. However, both groups were similar in their opinions about research collaborations. Conclusion: Sports clinical practice chiropractors, with their sports specialty designation and those without, differed in their opinions about sports chiropractic research priorities; however, they had similar opinions about research collaborations. These results suggest that it may be important to sample from both practitioner groups in future studies aimed at developing research agendas for chiropractic research in sport. PMID:28065995

Patient Engagement Practices in Clinical Research among Patient Groups, Industry, and Academia in the United States: A Survey

PubMed Central

Smith, Sophia K.; Selig, Wendy; Harker, Matthew; Roberts, Jamie N.; Hesterlee, Sharon; Leventhal, David; Klein, Richard; Patrick-Lake, Bray; Abernethy, Amy P.

2015-01-01

Objective Patient-centered clinical trial design and execution is becoming increasingly important. No best practice guidelines exist despite a key stakeholder declaration to create more effective engagement models. This study aims to gain a better understanding of attitudes and practices for engaging patient groups so that actionable recommendations may be developed. Methods Individuals from industry, academic institutions, and patient groups were identified through Clinical Trials Transformation Initiative and Drug Information Association rosters and mailing lists. Objectives, practices, and perceived barriers related to engaging patient groups in the planning, conduct, and interpretation of clinical trials were reported in an online survey. Descriptive and inferential statistical analysis of survey data followed a literature review to inform survey questions. Results Survey respondents (n = 179) valued the importance of involving patient groups in research; however, patient group respondents valued their contributions to research protocol development, funding acquisition, and interpretation of study results more highly than those contributions were valued by industry and academic respondents (all p < .001). Patient group respondents placed higher value in open communications, clear expectations, and detailed contract execution than did non–patient group respondents (all p < .05). Industry and academic respondents more often cited internal bureaucratic processes and reluctance to share information as engagement barriers than did patient group respondents (all p < .01). Patient groups reported that a lack of transparency and understanding of the benefits of collaboration on the part of industry and academia were greater barriers than did non–patient group respondents (all p< .01). Conclusions Despite reported similarities among approaches to engagement by the three stakeholder groups, key differences exist in perceived barriers and benefits to partnering with patient groups among the sectors studied. This recognition could inform the development of best practices for patient-centered clinical trial design and execution. Additional research is needed to define and optimize key success factors. PMID:26465328

Patient Engagement Practices in Clinical Research among Patient Groups, Industry, and Academia in the United States: A Survey.

PubMed

Smith, Sophia K; Selig, Wendy; Harker, Matthew; Roberts, Jamie N; Hesterlee, Sharon; Leventhal, David; Klein, Richard; Patrick-Lake, Bray; Abernethy, Amy P

2015-01-01

Patient-centered clinical trial design and execution is becoming increasingly important. No best practice guidelines exist despite a key stakeholder declaration to create more effective engagement models. This study aims to gain a better understanding of attitudes and practices for engaging patient groups so that actionable recommendations may be developed. Individuals from industry, academic institutions, and patient groups were identified through Clinical Trials Transformation Initiative and Drug Information Association rosters and mailing lists. Objectives, practices, and perceived barriers related to engaging patient groups in the planning, conduct, and interpretation of clinical trials were reported in an online survey. Descriptive and inferential statistical analysis of survey data followed a literature review to inform survey questions. Survey respondents (n = 179) valued the importance of involving patient groups in research; however, patient group respondents valued their contributions to research protocol development, funding acquisition, and interpretation of study results more highly than those contributions were valued by industry and academic respondents (all p < .001). Patient group respondents placed higher value in open communications, clear expectations, and detailed contract execution than did non-patient group respondents (all p < .05). Industry and academic respondents more often cited internal bureaucratic processes and reluctance to share information as engagement barriers than did patient group respondents (all p < .01). Patient groups reported that a lack of transparency and understanding of the benefits of collaboration on the part of industry and academia were greater barriers than did non-patient group respondents (all p< .01). Despite reported similarities among approaches to engagement by the three stakeholder groups, key differences exist in perceived barriers and benefits to partnering with patient groups among the sectors studied. This recognition could inform the development of best practices for patient-centered clinical trial design and execution. Additional research is needed to define and optimize key success factors.

Synergies and Distinctions between Computational Disciplines in Biomedical Research: Perspective from the Clinical and Translational Science Award Programs

PubMed Central

Bernstam, Elmer V.; Hersh, William R.; Johnson, Stephen B.; Chute, Christopher G.; Nguyen, Hien; Sim, Ida; Nahm, Meredith; Weiner, Mark; Miller, Perry; DiLaura, Robert P.; Overcash, Marc; Lehmann, Harold P.; Eichmann, David; Athey, Brian D.; Scheuermann, Richard H.; Anderson, Nick; Starren, Justin B.; Harris, Paul A.; Smith, Jack W.; Barbour, Ed; Silverstein, Jonathan C.; Krusch, David A.; Nagarajan, Rakesh; Becich, Michael J.

2010-01-01

Clinical and translational research increasingly requires computation. Projects may involve multiple computationally-oriented groups including information technology (IT) professionals, computer scientists and biomedical informaticians. However, many biomedical researchers are not aware of the distinctions among these complementary groups, leading to confusion, delays and sub-optimal results. Although written from the perspective of clinical and translational science award (CTSA) programs within academic medical centers, the paper addresses issues that extend beyond clinical and translational research. The authors describe the complementary but distinct roles of operational IT, research IT, computer science and biomedical informatics using a clinical data warehouse as a running example. In general, IT professionals focus on technology. The authors distinguish between two types of IT groups within academic medical centers: central or administrative IT (supporting the administrative computing needs of large organizations) and research IT (supporting the computing needs of researchers). Computer scientists focus on general issues of computation such as designing faster computers or more efficient algorithms, rather than specific applications. In contrast, informaticians are concerned with data, information and knowledge. Biomedical informaticians draw on a variety of tools, including but not limited to computers, to solve information problems in health care and biomedicine. The paper concludes with recommendations regarding administrative structures that can help to maximize the benefit of computation to biomedical research within academic health centers. PMID:19550198

Feasibility of a Centralized Clinical Trials Coverage Analysis: A Joint Initiative of the American Society of Clinical Oncology and the National Cancer Institute.

PubMed

Szczepanek, Connie M; Hurley, Patricia; Good, Marjorie J; Denicoff, Andrea; Willenberg, Kelly; Dawson, Casey; Kurbegov, Dax

2017-06-01

Clinical trial billing compliance is a challenge that is faced by overburdened clinical trials sites. The requirements place institutions and research sites at increased potential for financial risk. To reduce their risk, sites develop a coverage analysis (CA) before opening each trial. For multisite trials, this translates into system-wide redundancies, inconsistencies, trial delays, and potential costs to sites and patients. These factors exacerbate low accrual rates to cancer clinical trials. ASCO and the National Cancer Institute (NCI) collaborated to address this problem. An ASCO Research Community Forum working group proposed the concept of providing centrally developed CAs to research sites at protocol startup. The group collaborated with NCI and billing compliance experts to hold a symposium for key stakeholders to share knowledge, build skills, provide tools to conduct centralized CAs, and strategize about the next steps. Forty-eight attendees, who represented a range of stakeholders, participated in the symposium. As a result of this initiative, NCI directed the Cancer Trials Support Unit to convene a working group with NCI's National Clinical Trials Network (NCTN) and Community Oncology Research Program (NCORP) to develop tools and processes for generating CAs for their trials. A CA template with core elements was developed and is being adapted in a pilot project across NCTN Group and NCORP Research Bases. Centralized CAs for multisite trials-using standardized tools and templates-are feasible. They have the potential to reduce risk for patients and sites, forecast budget needs, and help decrease trial startup times that impede patient access and accrual to clinical trials.

Validation of clinic weights from electronic health records against standardized weight measurements in weight loss trials.

PubMed

Xiao, Lan; Lv, Nan; Rosas, Lisa G; Au, David; Ma, Jun

2017-02-01

To validate clinic weights in electronic health records against researcher-measured weights for outcome assessment in weight loss trials. Clinic and researcher-measured weights from a published trial (BE WELL) were compared using Lin's concordance correlation coefficient, Bland and Altman's limits of agreement, and polynomial regression model. Changes in clinic and researcher-measured weights in BE WELL and another trial, E-LITE, were analyzed using growth curve modeling. Among BE WELL (n = 330) and E-LITE (n = 241) participants, 96% and 90% had clinic weights (mean [SD] of 5.8 [6.1] and 3.7 [3.9] records) over 12 and 15 months of follow-up, respectively. The concordance correlation coefficient was 0.99, and limits of agreement plots showed no pattern between or within treatment groups, suggesting overall good agreement between researcher-measured and nearest-in-time clinic weights up to 3 months. The 95% confidence intervals for predicted percent differences fell within ±3% for clinic weights within 3 months of the researcher-measured weights. Furthermore, the growth curve slopes for clinic and researcher-measured weights by treatment group did not differ significantly, suggesting similar inferences about treatment effects over time, in both trials. Compared with researcher-measured weights, close-in-time clinic weights showed high agreement and inference validity. Clinic weights could be a valid pragmatic outcome measure in weight loss studies. © 2017 The Obesity Society.

Ethics and epistemology of accurate prediction in clinical research.

PubMed

Hey, Spencer Phillips

2015-07-01

All major research ethics policies assert that the ethical review of clinical trial protocols should include a systematic assessment of risks and benefits. But despite this policy, protocols do not typically contain explicit probability statements about the likely risks or benefits involved in the proposed research. In this essay, I articulate a range of ethical and epistemic advantages that explicit forecasting would offer to the health research enterprise. I then consider how some particular confidence levels may come into conflict with the principles of ethical research. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

Trends in Research with U.S. Military Service Member Participants: A Population-Specific ClinicalTrials.gov Review.

PubMed

Cook, Wendy A; Doorenbos, Ardith Z; Bridges, Elizabeth J

2016-08-15

ClinicalTrials.gov reviews have evaluated research trends for specific conditions and age groups but not for specific populations of research participants. No ClinicalTrials.gov reviews have evaluated research with military service member participants. Study objectives were (a) to use ClinicalTrials.gov to identify trends in biomedical research from 2005 to 2014 in which U.S. military service members actively participated as research participants and (b) to describe a search strategy for adaptation in future ClinicalTrials.gov reviews of specific participant populations. A systematic review of ClinicalTrials.gov was performed to identify studies that included U.S. service members as participants, either exclusively or with other groups of participants. U.S. service members were identified as participants in 512 studies. Service members participated together with other groups in 392 studies, while 120 studies included only service members. The top five conditions of interest were post-traumatic stress disorder, traumatic brain injury, amputations, burns, and ocular injuries/disorders. The number of studies started each year peaked in 2011 and declined from 2012 to 2014. Twenty-five percent of studies exclusive to service members aimed to enroll 500 or more participants. Research exclusive to Guard and Reserve service members during this period was limited. U.S. military service members participate in biomedical research. To address the health needs of U.S. service members, it is important to ensure there is not a prolonged decline in research among this population. The search strategy may be adapted to ClinicalTrials.gov reviews of specific participant populations for which straightforward searches are not possible.

The role and potential contribution of clinical research nurses to clinical trials.

PubMed

Spilsbury, Karen; Petherick, Emily; Cullum, Nicky; Nelson, Andrea; Nixon, Jane; Mason, Su

2008-02-01

This study explores the scope and potential contribution of the Clinical Research Nurse (CRN) role to clinical trials of a nursing-specific topic. Over the past two decades, there have been increases in the numbers of nurses working as CRNs because of the increasing global demand for clinical trials. CRNs can influence the quality of clinical trials but the scope and contribution of the role to clinical trials is not known. Qualitative focus group study. A focus group interview was carried out with CRNs (n = 9) employed on a large, multi-centre (six NHS Trusts) randomized controlled trial of pressure area care. The focus group interview was recorded, alongside field notes of participant interactions and behaviours, and transcribed verbatim. Data were analysed for thematic content and process. CRNs described their transition to a clinical research role. They reported a lack of confidence, role conflict as researcher and nurse, the challenges of gaining cooperation of clinical nursing staff to comply with trial protocols and difficulties maintaining their own motivation. CRNs provided their perceptions and observations of pressure area care and prevention. They identified areas of inadequate treatment, management and care, influenced by organizational and clinical aspects of care delivery. The study reveals challenges associated with training and management of CRNs. CRNs are usually associated with trial recruitment and data collection. This study highlights the additional contributions of CRNs for the study of topics specific to nursing as the result of their unique placement in the research centres as informal 'participant observers.' Such observations enhance understanding of the contexts being studied. These findings are relevant to the design and conduct of research studies of nursing care and practice and present ways for investigators to optimize the skills and knowledge of nurses working as CRNs.

Involving children and young people in clinical research through the forum of a European Young Persons' Advisory Group: needs and challenges.

PubMed

Gaillard, Segolene; Malik, Salma; Preston, Jenny; Escalera, Begonya Nafria; Dicks, Pamela; Touil, Nathalie; Mardirossian, Sandrine; Claverol-Torres, Joana; Kassaï, Behrouz

2018-02-19

Children and young people are seen as fundamental to the design and delivery of clinical research as active and reflective participants. In Europe, involvement of children and young people in clinical research is promoted extensively in order to engage young people in research as partners and to give them a voice to raise their own issues or opinions and for their involvement in planning and decision making in addition to learning research skills. Children and young people can be trained in clinical research through participation in young person advisory groups (YPAGs). Members of YPAGs assist other children and young people to learn about clinical research and share their experience and point of view with researchers, thereby possibly influencing all phases of research including the development and prioritization of research questions, design and methods, recruitment plans, and strategies for results dissemination. In the long term, the expansion of YPAGs in Europe will serve as a driving force for refining pediatric clinical research. It will help in a better definition of research projects according to the patients' needs. Furthermore, direct engagement of children and young people in research will be favorable to both researchers and young people. © 2018 Société Française de Pharmacologie et de Thérapeutique.

Using a handbook to improve nurses' continence care.

PubMed

Williams, K; Roe, B; Sindhu, F

Nursing care should be based on sound research evidence with demonstrated clinical effectiveness. Dissemination of this research evidence is, therefore, of paramount importance. A study using focus groups was undertaken during 1993-1994 to evaluate the dissemination of a clinical handbook for continence care to qualified nurses, in relation to reported nursing practice in care of the elderly wards/units in one health authority. A total of 124 nurses participated in the study and 98 variables were included. Improvements were recorded in nurses' responses between the pre-test and post-test for 84 (86 per cent) variables in the experimental group and 58 (59 per cent) in the control group. This demonstrates the positive value of the clinical handbook as a method of disseminating research evidence.

Lewy Body Dementia Association

MedlinePlus

... Services Local LBD Support Groups Caregiver Link Caregiving Materials Virtual Groups Caregiver Resources Related Organizations LBD stories submit a caregiver story forums Research Research News LBD: State of the Science Learn About Clinical Trials Participate in Research Funding ...

Enhancing the Alignment of the Preclinical and Clinical Stroke Recovery Research Pipeline: Consensus-Based Core Recommendations From the Stroke Recovery and Rehabilitation Roundtable Translational Working Group.

PubMed

Corbett, Dale; Carmichael, S Thomas; Murphy, Timothy H; Jones, Theresa A; Schwab, Martin E; Jolkkonen, Jukka; Clarkson, Andrew N; Dancause, Numa; Weiloch, Tadeusz; Johansen-Berg, Heidi; Nilsson, Michael; McCullough, Louise D; Joy, Mary T

2017-08-01

Stroke recovery research involves distinct biological and clinical targets compared to the study of acute stroke. Guidelines are proposed for the pre-clinical modeling of stroke recovery and for the alignment of pre-clinical studies to clinical trials in stroke recovery.

Clinical effectiveness of a cognitive behavioral group treatment program for anxiety disorders: a benchmarking study.

PubMed

Oei, Tian P S; Boschen, Mark J

2009-10-01

Previous research has established efficacy of cognitive behavioral therapy (CBT) for anxiety disorders, yet it has not been widely assessed in routine community clinic practices. Efficacy research sacrifices external validity to achieve maximum internal validity. Recently, effectiveness research has been advocated as more ecologically valid for assessing routine clinical work in community clinics. Furthermore, there is a lack of effectiveness research in group CBT. This study aims to extend existing research on the effectiveness of CBT from individual therapy into group therapy delivery. It aimed also to examine outcome using not only symptom measures, but also measures of related symptoms, cognitions, and life quality and satisfaction. Results from a cohort of patients with various anxiety disorders demonstrated that treatment was effective in reducing anxiety symptoms to an extent comparable with other effectiveness studies. Despite this, only 43% of individuals showed reliable change, and 17% were 'recovered' from their anxiety symptoms, and the post-treatment measures were still significantly different from the level of anxiety symptoms observed in the general population.

Best practices in social and behavioral research: report from the Enhancing Clinical Research Professional's Training and Qualifications project.

PubMed

Murphy, Susan L; Byks-Jazayeri, Christine; Calvin-Naylor, Nancy; Divecha, Vic; Anderson, Elizabeth; Eakin, Brenda; Fair, Alecia; Denton, Laura

2017-02-01

This article discusses the process of defining competencies and development of a best practices training course for investigators and clinical research coordinators who conduct social and behavioral research. The first project phase established recommendations for training in Good Clinical Practice (GCP) and was done in conjunction with representatives from 62 Clinical and Translational Science Award (CTSA) hubs. Diversity in behavioral clinical trials and differences in regulation of behavioral trials compared with clinical trials involving drugs, devices, or biologics necessitated a separate Social and Behavioral Work Group. This group worked with CTSA representatives to tailor competencies and fundamental GCP principles into best practices for social and behavioral research. Although concepts underlying GCP were deemed similar across all clinical trials, not all areas were equally applicable and the ways in which GCP would be enacted differ for behavioral trials. It was determined that suitable training in best practices for social and behavioral research was lacking. Based on the training need, an e-learning course for best practices is available to all CTSA sites. Each institution is able to track outcomes for its employees to help achieve standardized competency-based best practices for social and behavioral investigators and staff.

Outcomes research in cancer clinical trial cooperative groups: the RTOG model.

PubMed

Bruner, D W; Movsas, B; Konski, A; Roach, M; Bondy, M; Scarintino, C; Scott, C; Curran, W

2004-08-01

The Radiation Therapy Oncology Group (RTOG), a National Cancer Institute sponsored cancer clinical trials research cooperative, has recently formed an Outcomes Committee to assess a comprehensive array of clinical trial endpoints and factors impacting the net effect of therapy. To study outcomes in a consistent, comprehensive and coordinated manner, the RTOG Outcomes Committee developed a model to assess clinical, humanistic, and economic outcomes important in clinical trials. This paper reviews how the RTOG incorporates outcomes research into cancer clinical trials, and demonstrates utilization of the RTOG Outcomes Model to test hypotheses related to non-small-cell lung cancer (NSCLC). In this example, the clinical component of the model indicates that the addition of chemotherapy to radiotherapy (RT) improves survival but increases the risk of toxicity. The humanistic component indicates that esophagitis is the symptom impacting quality of life the greatest and may outweigh the benefits in elderly (> or =70 years) patients. The economic component of the model indicates that accounting for quality-adjusted survival, concurrent chemoRT for the treatment of NSCLC is within the range of economically acceptable recommendations. The RTOG Outcomes Model guides a comprehensive program of research that systematically measures a triad of endpoints considered important to clinical trials research.

Developing a data infrastructure for a learning health system: the PORTAL network.

PubMed

McGlynn, Elizabeth A; Lieu, Tracy A; Durham, Mary L; Bauck, Alan; Laws, Reesa; Go, Alan S; Chen, Jersey; Feigelson, Heather Spencer; Corley, Douglas A; Young, Deborah Rohm; Nelson, Andrew F; Davidson, Arthur J; Morales, Leo S; Kahn, Michael G

2014-01-01

The Kaiser Permanente & Strategic Partners Patient Outcomes Research To Advance Learning (PORTAL) network engages four healthcare delivery systems (Kaiser Permanente, Group Health Cooperative, HealthPartners, and Denver Health) and their affiliated research centers to create a new national network infrastructure that builds on existing relationships among these institutions. PORTAL is enhancing its current capabilities by expanding the scope of the common data model, paying particular attention to incorporating patient-reported data more systematically, implementing new multi-site data governance procedures, and integrating the PCORnet PopMedNet platform across our research centers. PORTAL is partnering with clinical research and patient experts to create cohorts of patients with a common diagnosis (colorectal cancer), a rare diagnosis (adolescents and adults with severe congenital heart disease), and adults who are overweight or obese, including those with pre-diabetes or diabetes, to conduct large-scale observational comparative effectiveness research and pragmatic clinical trials across diverse clinical care settings. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

Collaborative translational research leading to multicenter clinical trials in Duchenne muscular dystrophy: the Cooperative International Neuromuscular Research Group (CINRG).

PubMed

Escolar, Diana M; Henricson, Erik K; Pasquali, Livia; Gorni, Ksenija; Hoffman, Eric P

2002-10-01

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.

The European Prader-Willi Syndrome Clinical Research Database: an aid in the investigation of a rare genetically determined neurodevelopmental disorder.

PubMed

Holland, A; Whittington, J; Cohen, O; Curfs, L; Delahaye, F; Dudley, O; Horsthemke, B; Lindgren, A-C; Nourissier, C; Sharma, N; Vogels, A

2009-06-01

Prader-Willi Syndrome (PWS) is a rare genetically determined neurodevelopmental disorder with a complex phenotype that changes with age. The rarity of the syndrome and the need to control for different variables such as genetic sub-type, age and gender limits clinical studies of sufficient size in any one country. A clinical research database has been established to structure data collection and to enable multinational investigations into the development of children and adults with PWS. As part of a joint basic science and clinical study of PWS funded through Framework 6 of the European Union (EU), an expert multidisciplinary group was established that included clinicians involved in PWS research and clinical practice, expert database software developers, and representatives from two national PWS Associations. This group identified the key issues that required resolution and the data fields necessary for a comprehensive database to support PWS research. The database consists of six 'index' entry points and branching panels and sub-panels and over 1200 data 'fields'. It is Internet-based and designed to support multi-site clinical research in PWS. An algorithm ensures that participant data are anonymous. Access to data is controlled in a manner that is compatible with EU and national laws. The database determines the assessments to be used to collect data thereby enabling the combining of data from different groups under specifically agreed conditions. The data collected at any one time will be determined by individual research groups, who retain control of the data. Over time the database will accumulate data on participants with PWS that will support future research by avoiding the need for repeat data collection of fixed data and it will also enable longitudinal studies and treatment trials. The development of the database has proved to be complex with various administrative and ethical issues to be addressed. At an early stage, it was important to clarify the exact function of the database. It was agreed that it was primarily to support grant-funded research rather than clinical practice. The most complex issues that had to be addressed were concerned with data ownership and establishing the rules for data entry, retrieval and sharing that are compatible with data protection laws, and which are likely to be acceptable to participants and their families and to individual research groups.

The Evaluation of a Clinical Development Unit Leadership Preparation Program by Focus Group Interviews--Part I: Positive Aspects. Part II: Negative Aspects.

ERIC Educational Resources Information Center

Greenwood, Jennifer; Parsons, Myra

2002-01-01

Focus group evaluations of a training program for nurses leading clinical development units focused on research-based practice found that leadership and strategic skills were developed. However, participants had insufficient time to assimilate knowledge or develop mentoring relationships and needed more help developing research-receptive culture…

Assessing the effectiveness of a clinical instructor online training module as measured by student perception and sustained best practices.

PubMed

Engelhard, Chalee; Seo, Kay Kyeong-Ju

2015-01-01

Due to current scrutiny of physical therapy (PT) clinical education, clinical education models require revisions with close examination of current practice, including best practices in clinical instructor (CI) education. Unfortunately, depth of research currently available to support these revisions is minimal, particularly in areas of research that investigate maintaining recently taught skills in CI training and students' perceived CI effectiveness following training. This study's purpose was to explore these areas. CIs (n=21) were assigned to either a control or treatment group. Treatment group-CIs completed an online module prior to supervising a Doctor of Physical Therapy (DPT) student during a 9-week clinical rotation and then participated in data collection activities following the rotation. Data from control group-CIs established a baseline. Data from students' assessments of their CIs' performances yielded qualitative themes demonstrating differentiated learning environments and module-taught best practices for treatment group-students. Quantitative findings did not make a distinction between the two student groups. Lastly, treatment group-CIs maintained best practices after an inactive period. This study suggests CIs were able to maintain best practices using just-in-time education, distributed clinical practice, and reflection. By continuing examination of online CI education, PT clinical education can move toward new models through evidence-based CI best practices.

Return of Individual Research Results and Incidental Findings in the Clinical Trials Cooperative Group Setting

PubMed Central

Ferriere, Michael; Van Ness, Brian

2013-01-01

The NCI funded cooperative group cancer clinical trial system develops experimental therapies and often collects patient samples 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 ten consensus recommendations of Wolf et al. presented in this issue are examined. Re-identification 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. PMID:22382800

About the Gastrointestinal and Other Cancers Research Group | Division of Cancer Prevention

Cancer.gov

The Gastrointestinal and Other Cancers Research Group conducts and supports prevention and early detection research on colorectal, esophageal, liver, pancreatic, and hematolymphoid cancers, as well as new approaches to clinical prevention studies including cancer immunoprevention. |

Bias from historical control groups used in orthodontic research: a meta-epidemiological study.

PubMed

Papageorgiou, Spyridon N; Koretsi, Vasiliki; Jäger, Andreas

2017-02-01

The validity of meta-analysis is dependent upon the quality of included studies. Here, we investigated whether the design of untreated control groups (i.e. source and timing of data collection) influences the results of clinical trials in orthodontic research. This meta-epidemiological study used unrestricted literature searching for meta-analyses in orthodontics including clinical trials with untreated control groups. Differences in standardized mean differences (ΔSMD) and their 95% confidence intervals (CIs) were calculated according to the untreated control group through multivariable random-effects meta-regression controlling for nature of the interventional group and study sample size. Effects were pooled with random-effects synthesis, followed by mixed-effect subgroup and sensitivity analyses. Studies with historical control groups reported deflated treatment effects compared to studies with concurrent control groups (13 meta-analyses; ΔSMD = -0.31; 95% CI = -0.53, -0.10; P = 0.004). Significant differences were found according to the type of historical control group (based either on growth study or clinical archive; 11 meta-analyses; ΔSMD = 0.40; 95% CI = 0.21, 0.59; P < 0.001). The use of historical control groups in orthodontic clinical research was associated with deflation of treatment effects, which was independent from whether the interventional group was prospective or retrospective and from the study's sample size. Caution is warranted when interpreting clinical studies with historical untreated control groups or when interpreting systematic reviews that include such studies. PROSPERO (CRD42015024179). None. © The Author 2016. Published by Oxford University Press on behalf of the European Orthodontic Society. All rights reserved. For permissions, please email: journals.permissions@oup.com.

Effects of nursing process-based simulation for maternal child emergency nursing care on knowledge, attitude, and skills in clinical nurses.

PubMed

Kim, Sunghee; Shin, Gisoo

2016-02-01

Since previous studies on simulation-based education have been focused on fundamental nursing skills for nursing students in South Korea, there is little research available that focuses on clinical nurses in simulation-based training. Further, there is a paucity of research literature related to the integration of the nursing process into simulation training particularly in the emergency nursing care of high-risk maternal and neonatal patients. The purpose of this study was to identify the effects of nursing process-based simulation on knowledge, attitudes, and skills for maternal and child emergency nursing care in clinical nurses in South Korea. Data were collected from 49 nurses, 25 in the experimental group and 24 in the control group, from August 13 to 14, 2013. This study was an equivalent control group pre- and post-test experimental design to compare the differences in knowledge, attitudes, and skills for maternal and child emergency nursing care between the experimental group and the control group. The experimental group was trained by the nursing process-based simulation training program, while the control group received traditional methods of training for maternal and child emergency nursing care. The experimental group was more likely to improve knowledge, attitudes, and skills required for clinical judgment about maternal and child emergency nursing care than the control group. Among five stages of nursing process in simulation, the experimental group was more likely to improve clinical skills required for nursing diagnosis and nursing evaluation than the control group. These results will provide valuable information on developing nursing process-based simulation training to improve clinical competency in nurses. Further research should be conducted to verify the effectiveness of nursing process-based simulation with more diverse nurse groups on more diverse subjects in the future. Copyright © 2015 Elsevier Ltd. All rights reserved.

Improving recruitment to pharmacological trials for illicit opioid use: findings from a qualitative focus group study.

PubMed

Neale, Joanne; Tompkins, Charlotte N E; McDonald, Rebecca; Strang, John

2018-06-01

To explore potential study participants' views on willingness to join clinical trials of pharmacological interventions for illicit opioid use to inform and improve future recruitment strategies. Qualitative focus group study [six groups: oral methadone (two groups); buprenorphine tablets (two groups); injectable opioid agonist treatment (one group); and former opioid agonist treatment (one group)]. Drug and alcohol services and a peer support recovery service (London, UK). Forty people with experience of opioid agonist treatment for heroin dependence (26 males, 14 females; aged 33-66 years). Data collection was facilitated by a topic guide that explored willingness to enrol in clinical pharmacological trials. Groups were audio-recorded and transcribed. Transcribed data were analysed inductively via Iterative Categorization. Participants' willingness to join pharmacological trials of medications for opioid dependence was affected by factors relating to study burden, study drug, study design, study population and study relationships. Participants worried that the trial drug might be worse than, or interfere with, their current treatment. They also misunderstood aspects of trial design despite the researchers' explanations. Recruitment of participants for clinical trials of pharmacological interventions for illicit opioid use could be improved if researchers became better at explaining clinical trials to potential participants, dispelling misconceptions about trials and increasing trust in the research process and research establishment. A checklist of issues to consider when designing pharmacological trials for illicit opioid use is proposed. © 2018 The Authors. Addiction published by John Wiley & Sons Ltd on behalf of Society for the Study of Addiction.

Barriers and Strategies for Recruitment of Racial and Ethnic Minorities: Perspectives from Neurological Clinical Research Coordinators.

PubMed

Haley, Sean J; Southwick, Lauren E; Parikh, Nina S; Rivera, Jazmin; Farrar-Edwards, Dorothy; Boden-Albala, Bernadette

2017-12-01

Randomized controlled trials (RCTs) are the gold standard within evidence-based research. Low participant accrual rates, especially of underrepresented groups (e.g., racial-ethnic minorities), may jeopardize clinical studies' viability and strength of findings. Research has begun to unweave clinical trial mechanics, including the roles of clinical research coordinators, to improve trial participation rates. Two semi-structured focus groups were conducted with a purposive sample of 29 clinical research coordinators (CRCs) at consecutive international stroke conferences in 2013 and 2014 to gain in-depth understanding of coordinator-level barriers to racial-ethnic minority recruitment and retention into neurological trials. Coded transcripts were used to create themes to define concepts, identify associations, summarize findings, and posit explanations. Barriers related to translation, literacy, family composition, and severity of medical diagnosis were identified. Potential strategies included a focus on developing personal relationships with patients, community and patient education, centralized clinical trial administrative systems, and competency focused training and education for CRCs. Patient level barriers to clinical trial recruitment are well documented. Less is known about barriers facing CRCs. Further identification of how and when barriers manifest and the effectiveness of strategies to improve CRCs recruitment efforts is warranted.

Database on veterinary clinical research in homeopathy.

PubMed

Clausen, Jürgen; Albrecht, Henning

2010-07-01

The aim of the present report is to provide an overview of the first database on clinical research in veterinary homeopathy. Detailed searches in the database 'Veterinary Clinical Research-Database in Homeopathy' (http://www.carstens-stiftung.de/clinresvet/index.php). The database contains about 200 entries of randomised clinical trials, non-randomised clinical trials, observational studies, drug provings, case reports and case series. Twenty-two clinical fields are covered and eight different groups of species are included. The database is free of charge and open to all interested veterinarians and researchers. The database enables researchers and veterinarians, sceptics and supporters to get a quick overview of the status of veterinary clinical research in homeopathy and alleviates the preparation of systematical reviews or may stimulate reproductions or even new studies. 2010 Elsevier Ltd. All rights reserved.

Internet-delivered treatment for older adults with anxiety and depression: implementation of the Wellbeing Plus Course in routine clinical care and comparison with research trial outcomes.

PubMed

Staples, Lauren G; Fogliati, Vincent J; Dear, Blake F; Nielssen, Olav; Titov, Nickolai

2016-09-01

The Wellbeing Plus Course is an internet-delivered psychological intervention for older adults with anxiety or depression. To compare the effectiveness of the Wellbeing Plus Course in a public health setting (clinic group) with its efficacy in a randomised controlled trial (research group). Participants ( n =949) were Australian adults aged 60 and above. Primary outcome measures were the Patient Health Questionnaire (PHQ-9) and Generalized Anxiety Disorder scale (GAD-7). Initial symptom severity was higher in the clinic group and course completion was lower. Both groups showed significant symptom reductions at post-treatment and were satisfied with the treatment. Results were maintained at 3-month follow-up. Within-group symptom changes were comparable between settings; there were no between-group differences on primary outcomes or satisfaction. The Wellbeing Plus Course is as effective and acceptable in routine clinical care, as it is in controlled research trials. N.T. and B.F.D developed the Wellbeing Plus Course but derived no financial benefit from it. © The Royal College of Psychiatrists 2016. This is an open access article distributed under the terms of the Creative Commons Non-Commercial, No Derivatives (CC BY-NC-ND) license.

Promoting physical therapists' of research evidence to inform clinical practice: part 1--theoretical foundation, evidence, and description of the PEAK program.

PubMed

Tilson, Julie K; Mickan, Sharon

2014-06-25

There is a need for theoretically grounded and evidence-based interventions that enhance the use of research evidence in physical therapist practice. This paper and its companion paper introduce the Physical therapist-driven Education for Actionable Knowledge translation (PEAK) program, an educational program designed to promote physical therapists' integration of research evidence into clinical decision-making. The pedagogical foundations for the PEAK educational program include Albert Bandura's social cognitive theory and Malcolm Knowles's adult learning theory. Additionally, two complementary frameworks of knowledge translation, the Promoting Action on Research Implementation in Health Services (PARiHS) and Knowledge to Action (KTA) Cycle, were used to inform the organizational elements of the program. Finally, the program design was influenced by evidence from previous attempts to facilitate the use of research in practice at the individual and organizational levels. The 6-month PEAK program consisted of four consecutive and interdependent components. First, leadership support was secured and electronic resources were acquired and distributed to participants. Next, a two-day training workshop consisting of didactic and small group activities was conducted that addressed the five steps of evidence based practice. For five months following the workshop, participants worked in small groups to review and synthesize literature around a group-selected area of common clinical interest. Each group contributed to the generation of a "Best Practices List" - a list of locally generated, evidence-based, actionable behaviors relevant to the groups' clinical practice. Ultimately, participants agreed to implement the Best Practices List in their clinical practice. This, first of two companion papers, describes the underlying pedagogical theories, knowledge translation frameworks, and research evidence used to derive the PEAK program - an educational program designed to promote the use of research evidence to inform physical therapist practice. The four components of the program are described in detail. The companion paper reports the results of a mixed methods feasibility analysis of this complex educational intervention.

Do patients and health care professionals view the communication processes of clinical research differently? A Rasch analysis from a survey.

PubMed

González-de Paz, Luis; Kostov, Belchin; Solans-Julian, Pilar; Navarro-Rubio, M Dolores; Sisó-Almirall, Antoni

2015-10-01

The increasing amount of the clinical research conducted in the primary health care has enabled extending research beyond traditional settings, but this transfer has implied some trade-offs. Health care professionals who conduct research with trusted patients require assuming the ethical standards of research and communication skills to enable patients' autonomy and freedom of choice. This study aims to measure the opinions of health professionals and patients on issues of communication in clinical research. A cross-sectional study with health care professionals and patients from primary health care centres in Barcelona (Spain). Each group completed a similar self-administered questionnaire. A Rasch model was fitted to data. After examination of goodness-of-fit, differences between groups were compared using analysis of variance, and patients' measures were calibrated to professionals' measures to compare overall mean measures. Professionals and patients found the ethical attitudes most difficult to endorse related to trust in clinical researchers and conflicts of interest. Patients' perceptions of professional ethical behaviour were significantly lower than professionals'. Different item functioning between nurses and family doctors was found in the item on seeking ethical collaboration when collaborating in clinical research. Effective knowledge of ethical norms was associated with greater perceived ethical values in clinical research and confidence in health care professionals among patients. Differences in the views of the communication process between patients and professionals could alert research boards, health care institutions and researchers to the need for greater transparency, trust and ethical instruction when patients are involved in clinical research. © 2015 John Wiley & Sons, Ltd.

Clinical Criteria Versus a Possible Research Case Definition in Chronic Fatigue Syndrome/Myalgic Encephalomyelitis.

PubMed

Jason, Leonard A; McManimen, Stephanie; Sunnquist, Madison; Newton, Julia L; Strand, Elin Bolle

2017-01-01

The Institute of Medicine (IOM) recently developed clinical criteria for what had been known as chronic fatigue syndrome (CFS). Given the broad nature of the clinical IOM criteria, there is a need for a research definition that would select a more homogenous and impaired group of patients than the IOM clinical criteria. At the present time, it is unclear what will serve as the research definition. The current study focused on a research definition which selected homebound individuals who met the four IOM criteria, excluding medical and psychiatric co-morbidities. Our research criteria were compared to those participants meeting the IOM criteria. Those not meeting either of these criteria sets were placed in a separate group defined by 6 or more months of fatigue. Data analyzed were from the DePaul Symptom Questionnaire and the SF-36. Due to unequal sample sizes and variances, Welch's F tests and Games-Howell post hoc tests were conducted. Using a large database of over 1,000 patients from several countries, we found that those meeting a more restrictive research definition were even more impaired and more symptomatic than those meeting criteria for the other two groups. Deciding on a particular research case definition would allow researchers to select more comparable patient samples across settings, and this would represent one of the most significant methodologic advances for this field of study.

[Research activity in clinical biochemistry].

PubMed

Jørgensen, Henrik L; Larsen, Birger; Ingwersen, Peter; Rehfeld, Jens F

2008-09-01

Quantitative bibliometric measurements of research activity are frequently used, e.g. for evaluating applicants for academic positions. The purpose of this investigation is to assess research activity within the medical speciality of Clinical Biochemistry by comparing it with a matched control group from other medical specialities in Denmark. A list of all physicians registered in Denmark (23,127 persons) was drawn from the database "Laeger.dk". Of these, 5,202 were generalists (not included) while 11,691 were from other specialities. Of the 126 specialists from Clinical Biochemistry, 57 fulfilled the inclusion criteria. Each of these 57 was matched according to medical title with two randomly chosen specialists from other specialities, totaling 114. Using Medline and the Web of Science, the number of publications and the number of citations were then ascertained. 25% of the 11,691 specialists held a PhD degree or doctoral degree, DMSci, (Clinical Biochemistry: 61%). The 171 specialists included in the study had 9,823 papers in Medline and 10,140 papers in the Web of Science. The number of Medline papers per specialist was 71 for Clinical Biochemistry compared to 51 for the control group. The number of citations per specialist was 1,844 for Clinical Biochemistry compared to 816 for the control group. The top ten H-indices (of which 8 were in Clinical Biochemistry) ranged from 30 to 69. Both the number of papers and the number of citations were higher for Clinical Biochemistry than for the control group. The difference was most pronounced among professors.

About the Early Detection Research Group | Division of Cancer Prevention

Cancer.gov

The Early Detection Research Group supports research that seeks to determine the effectiveness, operating characteristics and clinical impact (harms as well as benefits) of cancer early detection technologies and practices, such as imaging and molecular biomarker approaches.   The group ran two large-scale early detection trials for which data and biospecimens are available

Culturally and Linguistically Diverse Populations in Medical Research: Perceptions and Experiences of Older Italians, Their Families, Ethics Administrators and Researchers.

PubMed

Woodward-Kron, Robyn; Hughson, Jo-Anne; Parker, Anna; Bresin, Agnese; Hajek, John; Knoch, Ute; Phan, Tuong Dien; Story, David

2016-04-26

Low-participation of culturally and linguistically diverse (CALD) patients in medical research remains a problem in migrant and refugee destination countries such as Australia. The aims of this study were to explore i) CALD persons' perceptions and experiences of the medical system and medical research, in this case, older Italian Australians; and ii) the views of research professionals on CALD patient participation in medical research. A qualitative study was conducted in Melbourne, Australia, in 2015 utilising in-depth interviews and focus groups with four stakeholder groups: older Italian Australians (n=21); adult children of older Italian Australians (n=10); hospital Human Research Ethics Committee administrators (n=4); and clinical researchers (n=4). The data were analysed for content and thematic analysis. Themes for the CALD and family group were getting by in medical interactions; receptivity to medical research: testing the waters; and, receptivity to technology for support: passive versus active. Themes for the researcher and HREC groups about CALD patient participation in research were: exclusion; cultural factors; and e-consent. Our findings from four stakeholder perspectives and experiences confirm that there were considerable cultural, linguistic, and resourcing barriers hindering the participation of older Italian-Australians in medical research. Furthermore, our findings showed that in this study setting there were few enabling strategies in place to address these barriers despite the national ethics guidelines for equitable participation in research. The findings informed the creation of a multimedia tool whose purpose is to address and improve representation of CALD groups in clinical research. Significance for public healthMany people from culturally and linguistically diverse (CALD) backgrounds remain excluded from medical research such as clinical trials due to a range of language and cultural factors that can be amplified when this population is ageing. This exclusion has implications for the ability of CALD populations to benefit from participating in medical research and for applying research findings to CALD populations. It is essential to develop and implement strategies to include CALD communities in medical research and to uphold the ethical obligation of obtaining informed consent to research. The findings of this study have guided the development of a tablet-based resource which can be used in clinical and community contexts to raise awareness about the purpose of medical research. The resource has been carefully designed to be appropriate for participants' cultural background as well as their preferred language and literacy level. Such a resource has potential to address some of the cultural and linguistic barriers to clinical trial participation of CALD populations.

Recommendations of the Global Multiple System Atrophy Research Roadmap Meeting.

PubMed

Walsh, Ryan R; Krismer, Florian; Galpern, Wendy R; Wenning, Gregor K; Low, Phillip A; Halliday, Glenda; Koroshetz, Walter J; Holton, Janice; Quinn, Niall P; Rascol, Olivier; Shaw, Leslie M; Eidelberg, David; Bower, Pam; Cummings, Jeffrey L; Abler, Victor; Biedenharn, Judy; Bitan, Gal; Brooks, David J; Brundin, Patrik; Fernandez, Hubert; Fortier, Philip; Freeman, Roy; Gasser, Thomas; Hewitt, Art; Höglinger, Günter U; Huentelman, Matt J; Jensen, Poul H; Jeromin, Andreas; Kang, Un Jung; Kaufmann, Horacio; Kellerman, Lawrence; Khurana, Vikram; Klockgether, Thomas; Kim, Woojin Scott; Langer, Carol; LeWitt, Peter; Masliah, Eliezer; Meissner, Wassilios; Melki, Ronald; Ostrowitzki, Susanne; Piantadosi, Steven; Poewe, Werner; Robertson, David; Roemer, Cyndi; Schenk, Dale; Schlossmacher, Michael; Schmahmann, Jeremy D; Seppi, Klaus; Shih, Lily; Siderowf, Andrew; Stebbins, Glenn T; Stefanova, Nadia; Tsuji, Shoji; Sutton, Sharon; Zhang, Jing

2018-01-09

Multiple system atrophy (MSA) is a rare neurodegenerative disorder with substantial knowledge gaps despite recent gains in basic and clinical research. In order to make further advances, concerted international collaboration is vital. In 2014, an international meeting involving leaders in the field and MSA advocacy groups was convened in Las Vegas, Nevada, to identify critical research areas where consensus and progress was needed to improve understanding, diagnosis, and treatment of the disease. Eight topic areas were defined: pathogenesis, preclinical modeling, target identification, endophenotyping, clinical measures, imaging biomarkers, nonimaging biomarkers, treatments/trial designs, and patient advocacy. For each topic area, an expert served as a working group chair and each working group developed priority-ranked research recommendations with associated timelines and pathways to reach the intended goals. In this report, each groups' recommendations are provided. Copyright © 2017 American Academy of Neurology.

Rap system of stress stimulation can promote bone union after lower tibial bone fracture: a clinical research.

PubMed

Yao, Jian-fei; Shen, Jia-zuo; Li, Da-kun; Lin, Da-sheng; Li, Lin; Li, Qiang; Qi, Peng; Lian, Ke-jian; Ding, Zhen-qi

2012-01-01

Lower tibial bone fracture may easily cause bone delayed union or nonunion because of lacking of dynamic mechanical load. Research Group would design a new instrument as Rap System of Stress Stimulation (RSSS) to provide dynamic mechanical load which would promote lower tibial bone union postoperatively. This clinical research was conducted from January 2008 to December 2010, 92 patients(male 61/female 31, age 16-70 years, mean 36.3 years) who suffered lower tibial bone closed fracture were given intramedullary nail fixation and randomly averagely separated into experimental group and control group(according to the successively order when patients went for the admission procedure). Then researchers analysed the clinical healing time, full weight bearing time, VAS (Visual Analogue Scales) score and callus growth score of Lane-Sandhu in 3,6,12 months postoperatively. The delayed union and nonunion rates were compared at 6 and 12 months separately. All the 92 patients had been followed up (mean 14 months). Clinical bone healing time in experimental group was 88.78±8.80 days but control group was 107.91±9.03 days. Full weight bearing time in experimental group was 94.07±9.81 days but control group was 113.24±13.37 days respectively (P<0.05). The delayed union rate in 6 months was 4.3% in experimental group but 10.9% in control group(P<0.05). The nonunion rate in 12 months was 6.5% in experimental group but 19.6% in control group(P<0.05). In 3, 6, 12 months postoperatively, VAS score and Lane-Sandhu score in experimental group had more significantly difference than them in control group. RSSS can intermittently provide dynamic mechanical load and stimulate callus formation, promote lower tibial bone union, reduce bone delayed union or nonunion rate. It is an adjuvant therapy for promoting bone union after lower tibial bone fracture.

The influence of an elective introductory clinical research course on pharmacy student interest in pursuing research-based careers.

PubMed

Overholser, Brian R; Foster, David R; Henry, Joshua R; Plake, Kimberly S; Sowinski, Kevin M

2010-11-10

To assess the impact of an elective clinical research course on second- and third-year pharmacy students' knowledge of clinical research methods, training programs, career options, and interest in pursuing postgraduate training. A 2-credit hour elective course in clinical research was designed that included lectures, discussions, workshops, and in-class presentations related to study design and implementation, protocol synthesis, research evaluation, ethical and legal considerations, data analysis, and professional opportunities involving clinical research. Learner knowledge of these topics was assessed using several methods, including 3 assignments related to research protocol, ethical documentation, and presentation. A survey instrument designed to evaluate the effect the course had on pharmacy students' knowledge of clinical research methods and interest in pursuing postgraduate training in clinical research was administered. Students who completed the elective had a greater level of familiarity with research-related topics, training options, and career opportunities (p < 0.05) and a greater interest in pursuing a career in clinical research (p < 0.05) than did students in a matched control group. Taking a 2-credit hour elective course in clinical research increased pharmacy students' interest in pursuing a career in clinical research.

Quality of life research in endometrial cancer: what is needed to advance progress in this disease site? Methodological considerations from the Gynecologic Cancer InterGroup Symptom Benefit Working Group brainstorming session, Leiden 2012.

PubMed

McAlpine, Jessica N; Greimel, Elfriede; Brotto, Lori A; Nout, Remy A; Shash, Emad; Avall-Lundqvist, Elisabeth; Friedlander, Michael L; Joly, Florence

2014-11-01

Quality of life (QoL) in endometrial cancer (EC) is understudied. Incorporation of QoL questionnaires and patient-reported outcomes in clinical trials has been inconsistent, and the tools and interpretation of these measures are unfamiliar to most practitioners. In 2012, the Gynecologic Cancer InterGroup Symptom Benefit Working Group convened for a brainstorming collaborative session to address deficiencies and work toward improving the quality and quantity of QoL research in women with EC. Through literature review and international expert contributions, we compiled a comprehensive appraisal of current generic and disease site-specific QoL assessment tools, strengths and weaknesses of these measures, assessment of sexual health, statistical considerations, and an exploration of the unique array of histopathologic and clinical factors that may influence QoL outcomes in women with EC. This collaborative composition is the first publication specific to EC that addresses methodology in QoL research and the components necessary to achieve high quality QoL data in clinical trials. Future recommendations regarding (1) the incorporation of patient-reported outcomes in all clinical trials in EC, (2) definition of an a priori hypothesis, (3) utilization of validated tools and consideration of new tools corresponding to new therapies or specific symptoms, (4) publication within the same time frame as clinical outcome data, and (5) attempt to correct for disease site-specific potential confounders are presented. Improved understanding of methodology in QoL research and an increased undertaking of EC-specific QoL research in clinical trials are imperative if we are to improve outcomes in women with EC.

The effect of short-term workshop on improving clinical reasoning skill of medical students

PubMed Central

Yousefichaijan, Parsa; Jafari, Farshad; Kahbazi, Manijeh; Rafiei, Mohammad; Pakniyat, AbdolGhader

2016-01-01

Background: Clinical reasoning process leads clinician to get purposeful steps from signs and symptoms toward diagnosis and treatment. This research intends to investigate the effect of teaching clinical reasoning on problem-solving skills of medical students. Methods: This research is a semi-experimental study. Nineteen Medical student of the pediatric ward as case group participated in a two-day workshop for training clinical reasoning. Before the workshop, they filled out Diagnostic Thinking Inventory (DTI) questionnaires. Fifteen days after the workshop the DTI questionnaire completed and "key feature" (KF) test and "clinical reasoning problem" (CRP) test was held. 23 Medical student as the control group, without passing the clinical reasoning workshop DTI questionnaire completed, and KF test and CRP test was held. Results: The average score of the DTI questionnaire in the control group was 162.04 and in the case group before the workshop was 153.26 and after the workshop was 181.68. Compare the average score of the DTI questionnaire before and after the workshop there is a significant difference. The difference between average KF test scores in the control and the case group was not significant but between average CRP test scores was significant. Conclusion: Clinical reasoning workshop is effectiveness in promoting problem-solving skills of students. PMID:27579286

The effect of short-term workshop on improving clinical reasoning skill of medical students.

PubMed

Yousefichaijan, Parsa; Jafari, Farshad; Kahbazi, Manijeh; Rafiei, Mohammad; Pakniyat, AbdolGhader

2016-01-01

Clinical reasoning process leads clinician to get purposeful steps from signs and symptoms toward diagnosis and treatment. This research intends to investigate the effect of teaching clinical reasoning on problem-solving skills of medical students. This research is a semi-experimental study. Nineteen Medical student of the pediatric ward as case group participated in a two-day workshop for training clinical reasoning. Before the workshop, they filled out Diagnostic Thinking Inventory (DTI) questionnaires. Fifteen days after the workshop the DTI questionnaire completed and "key feature" (KF) test and "clinical reasoning problem" (CRP) test was held. 23 Medical student as the control group, without passing the clinical reasoning workshop DTI questionnaire completed, and KF test and CRP test was held. The average score of the DTI questionnaire in the control group was 162.04 and in the case group before the workshop was 153.26 and after the workshop was 181.68. Compare the average score of the DTI questionnaire before and after the workshop there is a significant difference. The difference between average KF test scores in the control and the case group was not significant but between average CRP test scores was significant. Clinical reasoning workshop is effectiveness in promoting problem-solving skills of students.

The Hampstead Clinic at work. Discussions in the Diagnostic Profile Research Group.

PubMed

Koch, Ehud

2012-01-01

Minutes of the Hampstead Clinic's Diagnostic Profile Research Group during a fifteen-month period (1964-1965) are reviewed and discussed. A wide range of topics were considered and discussed, with a special focus on the affective life, object relations, and ego function of atypical children in comparison to the early ego functions and differentiation of normal and neurotic children. These lively clinical and theoretical discussions and their implications for therapeutic work with a wide range of children, demonstrate the multifaceted leadership and contributions of Anna Freud as teacher, clinician, and thinker, and of the Hampstead Clinic as a major center for psychoanalytic studies.

Data-Gathering, Belief Flexibility, and Reasoning Across the Psychosis Continuum.

PubMed

Ward, Thomas; Peters, Emmanuelle; Jackson, Mike; Day, Fern; Garety, Philippa A

2018-01-13

There is evidence for a group of nonclinical individuals with full-blown, persistent psychotic experiences (PEs) but no need-for-care: they are of particular importance in identifying risk and protective factors for clinical psychosis. The aim of this study was to investigate whether reasoning biases are related to PEs or need-for-care. Two groups with persistent PEs (clinical; n = 74; nonclinical; n = 92) and a control group without PEs (n = 83) were compared on jumping-to-conclusions (JTC) and belief flexibility. A randomly selected subset of interviews (n = 104) was analyzed to examine differences in experiential and rational reasoning. As predicted JTC was more common in the clinical than the other 2 groups. Unexpectedly no group differences were observed between clinical and nonclinical groups on measures of belief flexibility. However, the clinical group was less likely to employ rational reasoning, while the nonclinical group was more likely to use experiential reasoning plus a combination of both types of reasoning processes, compared to the other 2 groups. Reasoning biases differ in groups with PEs with and without need-for-care. JTC is associated with need-for-care rather than with PEs. The ability to invoke rational reasoning processes, together with an absence of JTC, may protect against pathological outcomes of persistent PEs. However, marked use of experiential reasoning is associated with the occurrence of PEs in both clinical and nonclinical groups. Implications for theory development, intervention and further research are discussed. © The Author 2017. Published by Oxford University Press on behalf of the Maryland Psychiatric Research Center.

Core schemas across the continuum of psychosis: a comparison of clinical and non-clinical groups.

PubMed

Taylor, Hannah E; Stewart, Suzanne L K; Dunn, Graham; Parker, Sophie; Fowler, David; Morrison, Anthony P

2014-11-01

Research suggests that core schemas are important in both the development and maintenance of psychosis. The aim of the study was to investigate and compare core schemas in four groups along the continuum of psychosis and examine the relationships between schemas and positive psychotic symptomatology. A measure of core schemas was distributed to 20 individuals experiencing first-episode psychosis (FEP), 113 individuals with "at risk mental states" (ARMS), 28 participants forming a help-seeking clinical group (HSC), and 30 non-help-seeking individuals who endorse some psychotic-like experiences (NH). The clinical groups scored significantly higher than the NH group for negative beliefs about self and about others. No significant effects of group on positive beliefs about others were found. For positive beliefs about the self, the NH group scored significantly higher than the clinical groups. Furthermore, negative beliefs about self and others were related to positive psychotic symptomatology and to distress related to those experiences. Negative evaluations of the self and others appear to be characteristic of the appraisals of people seeking help for psychosis and psychosis-like experiences. The results support the literature that suggests that self-esteem should be a target for intervention. Future research would benefit from including comparison groups of people experiencing chronic psychosis and people who do not have any psychotic-like experiences.

Better Together: The Making and Maturation of the Palliative Care Research Cooperative Group.

PubMed

Ritchie, Christine L; Pollak, Kathryn I; Kehl, Karen A; Miller, Jeri L; Kutner, Jean S

2017-06-01

To describe the growth and outcomes of the Palliative Care Research Cooperative Group (PCRC). Despite advances, significant gaps remain in the evidence base to inform care for people with serious illness. To generate this needed evidence and bolster research capacity, the Palliative Care Research Cooperative (PCRC) group was formed. The PCRC supports investigators in the conduct of multisite clinical studies. After developing a governance structure and completing a proof of concept demonstration study, the PCRC expanded its infrastructure to include additional resource cores (Clinical Studies; Measurement; Data Informatics and Statistics; and Caregiver Studies). The PCRC also supports an Investigator Development Center as many palliative care investigators valued opportunities to advance their skills. Additional key aspects of PCRC resources include a Scientific Review Committee, a Publications Committee, and initiatives to purposefully engage investigators in a community of palliative care science. The PCRC has grown to over 300 members representing more than 130 distinct sites. To date, the PCRC has supported the submission of 51 research applications and has engaged in 27 studies. The PCRC supports investigator research development needs through webinars and clinical trials "intensives." To foster a sense of community, the PCRC has convened biannual meetings, developed special interest groups, and regularly communicates via a newsletter and its website. With a particular focus on facilitating conduct of rigorous multisite clinical studies, the PCRC fosters an engaged multidisciplinary research community, filling an important void in generating and disseminating evidence that informs the provision of high-quality care to people with serious illness.

Researching asthma across the ages: insights from the National Heart, Lung, and Blood Institute's Asthma Network.

PubMed

Cabana, Michael D; Kunselman, Susan J; Nyenhuis, Sharmilee M; Wechsler, Michael E

2014-01-01

Clinical asthma studies across different age groups (ie, cross-age studies) can potentially offer insight into the similarities, differences, and relationships between childhood and adult asthma. The National Institutes of Health's Asthma Research Network (AsthmaNet) is unique and innovative in that it has merged pediatric and adult asthma research into a single clinical research network. This combination enhances scientific exchange between pediatric and adult asthma investigators and encourages the application of cross-age studies that involve participants from multiple age groups who are generally not studied together. The experience from AsthmaNet in the development of cross-age protocols highlights some of the issues in the evaluation of cross-age research in asthma. The aim of this review is to summarize these challenges, including the selection of parallel cross-age clinical interventions, identification of appropriate controls, measurement of meaningful clinical outcomes, and various ethical and logistic issues. Copyright © 2013 American Academy of Allergy, Asthma & Immunology. Published by Mosby, Inc. All rights reserved.

EULAR recommendations for conducting clinical studies and/or clinical trials in systemic vasculitis: focus on anti‐neutrophil cytoplasm antibody‐associated vasculitis

PubMed Central

Hellmich, Bernhard; Flossmann, Oliver; Gross, Wolfgang L; Bacon, Paul; Cohen‐Tervaert, Jan Willem; Guillevin, Loic; Jayne, David; Mahr, Alfred; Merkel, Peter A; Raspe, Heiner; Scott, David G I; Witter, James; Yazici, Hasan; Luqmani, Raashid A

2007-01-01

Objectives To develop the European League Against Rheumatism (EULAR) recommendations for conducting clinical studies and/or clinical trials in systemic vasculitis. Methods An expert consensus group was formed consisting of rheumatologists, nephrologists and specialists in internal medicine representing five European countries and the USA, a clinical epidemiologist and representatives from regulatory agencies. Using an evidence‐based and expert opinion‐based approach in accordance with the standardised EULAR operating procedures, the group identified nine topics for a systematic literature search through a modified Delphi technique. On the basis of research questions posed by the group, recommendations were derived for conducting clinical studies and/or clinical trials in systemic vasculitis. Results Based on the results of the literature research, the expert committee concluded that sufficient evidence to formulate guidelines on conducting clinical trials was available only for anti‐neutrophil cytoplasm antibody‐associated vasculitides (AAV). It was therefore decided to focus the recommendations on these diseases. Recommendations for conducting clinical trials in AAV were elaborated and are presented in this summary document. It was decided to consider vasculitis‐specific issues rather than general issues of trial methodology. The recommendations deal with the following areas related to clinical studies of vasculitis: definitions of disease, activity states, outcome measures, eligibility criteria, trial design including relevant end points, and biomarkers. A number of aspects of trial methodology were deemed important for future research. Conclusions On the basis of expert opinion, recommendations for conducting clinical trials in AAV were formulated. Furthermore, the expert committee identified a strong need for well‐designed research in non‐AAV systemic vasculitides. PMID:17170053

Integrating evidence-based practice into RN-to-BSN clinical nursing education.

PubMed

Oh, Eui Geum; Kim, Sunah; Kim, So Sun; Kim, Sue; Cho, Eun Yong; Yoo, Ji-Soo; Kim, Hee Soon; Lee, Ju Hee; You, Mi Ae; Lee, Hyejung

2010-07-01

This study examines the effects of integrating evidence-based practice (EBP) into clinical practicum on EBP efficacy and barriers to research utilization among Korean RN-to-BSN students. A one-group pretest-posttest design was used. Eighty-one students were recruited from a school of nursing in Korea. Evidence-based practice clinical practicum was composed of two consecutive programs during one semester. Lectures, individual mentoring on EBP practicum, small group, and wrap-up conferences were provided. Outcomes of EBP efficacy and barriers to research utilization were analyzed using paired t tests for 74 final participants. Evidence-based practice efficacy scores increased significantly (p < 0.05), and the barriers to research utilization scores decreased significantly after the EBP clinical practicum. The results highlight the effectiveness of EBP education among RN-to-BSN students. These results may help health educators develop effective educational strategies to integrate EBP concepts into a clinical practicum. Copyright 2010, SLACK Incorporated.

Older Adults' Perspectives on Clinical Research: A Focus Group and Survey Study.

PubMed

Lenze, Eric J; Ramsey, Alex; Brown, Patrick J; Reynolds, Charles F; Mulsant, Benoit H; Lavretsky, Helen; Roose, Steven P

2016-10-01

Clinical trials can benefit from patient perspectives to inform trial design, such as choice of outcome measures. We engaged older adults in focus groups and surveys to get their perspective regarding needs in clinical research. The goal was to inform the development of a new clinical trial of medication strategies for treatment-resistant depression in older adults. Older adults with depression participated in focus groups and a subsequent survey in St. Louis and New York. They were queried regarding research design features including outcomes, clinical management, mobile technology and iPad-administered assessments, the collection of DNA, and the receipt of their personal results. Patients told us: (1) psychological well-being and symptomatic remission are outcomes that matter to them; (2) it is important to measure not only benefits but risks (such as risk of falling) of medications; (3) for pragmatic trials in clinical settings, the research team should provide support to clinicians to ensure that medications are properly prescribed; (4) technology-based assessments are acceptable but there were concerns about data security and burden; (5) DNA testing is very important if it could improve precision care; (6) participants want to receive aggregate findings and their own personal results at the end of the study. Patients gave useful and wide-ranging guidance regarding clinical and comparative effectiveness research in older adults. We discuss these findings with the goal of making the next generation of geriatric studies more impactful and patient-centered. Copyright © 2016 American Association for Geriatric Psychiatry. Published by Elsevier Inc. All rights reserved.

Telling our stories: heroin-assisted treatment and SNAP activism in the Downtown Eastside of Vancouver.

PubMed

Boyd, Susan; Murray, Dave; MacPherson, Donald

2017-05-18

This article highlights the experiences of a peer-run group, SALOME/NAOMI Association of Patients (SNAP), that meets weekly in the Downtown Eastside of Vancouver, British Columbia, Canada. SNAP is a unique independent peer- run drug user group that formed in 2011 following Canada's first heroin-assisted treatment trial (HAT), North America Opiate Medication Initiative (NAOMI). SNAP's members are now made up of former research participants who participated in two heroin-assisted trials in Vancouver. This article highlights SNAP members' experiences as research subjects in Canada's second clinical trial conducted in Vancouver, Study to Assess Longer-term Opioid Medication Effectiveness (SALOME), that began recruitment of research participants in 2011. This paper draws on one brainstorming session, three focus groups, and field notes, with the SALOME/NAOMI Association of Patients (SNAP) in late 2013 about their experiences as research subjects in Canada's second clinical trial, SALOME in the DTES of Vancouver, and fieldwork from a 6-year period (March 2011 to February 2017) with SNAP members. SNAP's research draws on research principles developed by drug user groups and critical methodological frameworks on community-based research for social justice. The results illuminate how participating in the SALOME clinical trial impacted the lives of SNAP members. In addition, the findings reveal how SNAP member's advocacy for HAT impacts the group in positive ways. Seven major themes emerged from the analysis of the brainstorming and focus groups: life prior to SALOME, the clinic setting and routine, stability, 6-month transition, support, exiting the trial and ethics, and collective action, including their participation in a constitutional challenge in the Supreme Court of BC to continue receiving HAT once the SALOME trial ended. HAT benefits SNAP members. They argue that permanent HAT programs should be established in Canada because they are an effective harm reduction initiative, one that also reduces opioid overdose deaths.

Clinical psychologists' experiences of reflective staff groups in inpatient psychiatric settings: a mixed methods study.

PubMed

Heneghan, Cara; Wright, John; Watson, Gilli

2014-01-01

Background Reflective practice groups have been recommended for improving staff wellbeing and team functioning in inpatient psychiatric services, and clinical psychologists have been identified as potential leaders in this type of work. Research is limited with little information about reflective practice group guidelines, prevalence and effectiveness. Aims The aims of this study were to describe clinical psychologists' practice in reflective groups for staff in inpatient psychiatric services and to explore how such groups are conceptualized and implemented. Methods Online questionnaires and follow-up interviews were used to gain broad descriptions of practice and in-depth information about participants' experiences. The sample consisted of 73 clinical psychologists working in the UK, six of whom were interviewed. Data were analysed using descriptive statistics, content analysis and thematic analysis. Results Clinical psychologists regularly facilitate reflective staff groups in inpatient psychiatric settings in the UK. Common outcomes related to staff wellbeing, service culture and teamwork. Engagement, group dynamics and lack of management support were common challenges. Group experiences were influenced by the organizational context. Conclusions Clinical psychologists' practices regarding reflective staff groups were in line with recent professional developments. Several difficulties were described, which may be indicative of both a difficulty inherent to the task and a training gap in reflective staff group process. The study had methodological limitations but offers a useful contribution to the literature, and enables practice and training implications to be drawn. The need for further research exploring facilitator characteristics, views of group participants and the impact of reflective staff groups on patients is indicated. The term 'reflective practice group' encompasses a range of practices, but a typical group structure was found with common aims, outcomes and challenges. Reflective staff groups are regularly facilitated by clinical psychologists in inpatient psychiatric settings in the UK and are influenced by practitioner experience as well as psychodynamic, systemic and group process theories. The safety required for reflective groups to function is influenced by the organizational context, and groups can contribute to shifts in culture toward including psychosocial perspectives. Reflective staff groups represent one type of contribution to an inpatient psychiatric service and team relationships; other processes to encourage alternative professional perspectives and values might also support change. More research is recommended to explore facilitator characteristics, the views of staff teams on reflective staff groups and the impact of these groups on patients. Copyright © 2013 John Wiley & Sons, Ltd.

PPB | What is a Clinical Study

Cancer.gov

The Pleuropulmonary blastoma (PPB) DICER1 Syndrome Study ‹an observational clinical research study‹is enrolling children with PPB and their families. In an observational study, investigators assess health outcomes in groups of participants according to a protocol or research plan.

Enacting the ‘neuro’ in practice: Translational research, adhesion and the promise of porosity

PubMed Central

Michael, Mike

2014-01-01

This article attends to the processes through which neuroscience and the neuro are enacted in a specific context: a translational neuroscience research group that was the setting of an ethnographic study. The article therefore provides a close-up perspective on the intersection of neuroscience and translational research. In the scientific setting we studied, the neuro was multiple and irreducible to any particular entity or set of practices across a laboratory and clinical divide. Despite this multiplicity, the group’s work was held together through the ‘promise of porosity’ – that one day there would be translation of lab findings into clinically effective intervention. This promise was embodied in the figure of the Group Leader whose expertise spanned clinical and basic neurosciences. This is theorized in terms of a contrast between cohesion and adhesion in interdisciplinary groupings. We end by speculating on the role of ‘vivification’ – in our case mediated by the Group Leader – in rendering ‘alive’ the expectations of interdisciplinary collaboration. PMID:25362829

Improving recruitment to pharmacological trials for illicit opioid use: findings from a qualitative focus group study

PubMed Central

Tompkins, Charlotte N. E.; McDonald, Rebecca; Strang, John

2018-01-01

Abstract Aim To explore potential study participants’ views on willingness to join clinical trials of pharmacological interventions for illicit opioid use to inform and improve future recruitment strategies. Design Qualitative focus group study [six groups: oral methadone (two groups); buprenorphine tablets (two groups); injectable opioid agonist treatment (one group); and former opioid agonist treatment (one group)]. Settings Drug and alcohol services and a peer support recovery service (London, UK). Participants Forty people with experience of opioid agonist treatment for heroin dependence (26 males, 14 females; aged 33–66 years). Measurements Data collection was facilitated by a topic guide that explored willingness to enrol in clinical pharmacological trials. Groups were audio‐recorded and transcribed. Transcribed data were analysed inductively via Iterative Categorization. Findings Participants’ willingness to join pharmacological trials of medications for opioid dependence was affected by factors relating to study burden, study drug, study design, study population and study relationships. Participants worried that the trial drug might be worse than, or interfere with, their current treatment. They also misunderstood aspects of trial design despite the researchers’ explanations. Conclusions Recruitment of participants for clinical trials of pharmacological interventions for illicit opioid use could be improved if researchers became better at explaining clinical trials to potential participants, dispelling misconceptions about trials and increasing trust in the research process and research establishment. A checklist of issues to consider when designing pharmacological trials for illicit opioid use is proposed. PMID:29356208

Global oral health inequalities: dental caries task group--research agenda.

PubMed

Pitts, N; Amaechi, B; Niederman, R; Acevedo, A-M; Vianna, R; Ganss, C; Ismail, A; Honkala, E

2011-05-01

The IADR Global Oral Health Inequalities Task Group on Dental Caries has synthesized current evidence and opinion to identify a five-year implementation and research agenda which should lead to improvements in global oral health, with particular reference to the implementation of current best evidence as well as integrated action to reduce caries and health inequalities between and within countries. The Group determined that research should: integrate health and oral health wherever possible, using common risk factors; be able to respond to and influence international developments in health, healthcare, and health payment systems as well as dental prevention and materials; and exploit the potential for novel funding partnerships with industry and foundations. More effective communication between and among the basic science, clinical science, and health promotion/public health research communities is needed. Translation of research into policy and practice should be a priority for all. Both community and individual interventions need tailoring to achieve a more equal and person-centered preventive focus and reduce any social gradient in health. Recommendations are made for both clinical and public health implementation of existing research and for caries-related research agendas in clinical science, health promotion/public health, and basic science.

Patient participation in ERS guidelines and research projects: the EMBARC experience

PubMed Central

Timothy, Alan; Polverino, Eva; Almagro, Marta; Ruddy, Thomas; Powell, Pippa; Boyd, Jeanette

2017-01-01

The European Multicentre Bronchiectasis Audit and Research Collaboration (EMBARC) is a European Respiratory Society (ERS) Clinical Research Collaboration dedicated to improving research and clinical care for people with bronchiectasis. EMBARC has created a European Bronchiectasis Registry, funded by the ERS and by the European Union (EU) Innovative Medicines Initiative Programme. From the outset, EMBARC had the ambition to be a patient-focussed project. In contrast to many respiratory diseases, however, there are no specific patient charities or European patient organisations for patients with bronchiectasis and no existing infrastructure for patient engagement. This article describes the experience of EMBARC and the European Lung Foundation in establishing a patient advisory group and then engaging this group in European guidelines, an international registry and a series of research studies. Patient involvement in research, clinical guidelines and educational activities is increasingly advocated and increasingly important. Genuine patient engagement can achieve a number of goals that are critical to the success of an EU project, including focussing activities on patient priorities, allowing patients to direct the clinical and research agenda, and dissemination of guidelines and research findings to patients and the general public. Here, we review lessons learned and provide guidance for future ERS task forces, EU-funded projects or clinical research collaborations that are considering patient involvement. Educational aims To understand the different ways in which patients can contribute to clinical guidelines, research projects and educational activities. To understand the barriers and potential solutions to these barriers from a physician’s perspective, in order to ensure meaningful patient involvement in clinical projects. To understand the barriers and potential solutions from a patient’s perspective, in order to meaningfully involve patients in clinical projects. PMID:28894480

Patient participation in ERS guidelines and research projects: the EMBARC experience.

PubMed

Chalmers, James D; Timothy, Alan; Polverino, Eva; Almagro, Marta; Ruddy, Thomas; Powell, Pippa; Boyd, Jeanette

2017-09-01

The European Multicentre Bronchiectasis Audit and Research Collaboration (EMBARC) is a European Respiratory Society (ERS) Clinical Research Collaboration dedicated to improving research and clinical care for people with bronchiectasis. EMBARC has created a European Bronchiectasis Registry, funded by the ERS and by the European Union (EU) Innovative Medicines Initiative Programme. From the outset, EMBARC had the ambition to be a patient-focussed project. In contrast to many respiratory diseases, however, there are no specific patient charities or European patient organisations for patients with bronchiectasis and no existing infrastructure for patient engagement. This article describes the experience of EMBARC and the European Lung Foundation in establishing a patient advisory group and then engaging this group in European guidelines, an international registry and a series of research studies. Patient involvement in research, clinical guidelines and educational activities is increasingly advocated and increasingly important. Genuine patient engagement can achieve a number of goals that are critical to the success of an EU project, including focussing activities on patient priorities, allowing patients to direct the clinical and research agenda, and dissemination of guidelines and research findings to patients and the general public. Here, we review lessons learned and provide guidance for future ERS task forces, EU-funded projects or clinical research collaborations that are considering patient involvement. To understand the different ways in which patients can contribute to clinical guidelines, research projects and educational activities.To understand the barriers and potential solutions to these barriers from a physician's perspective, in order to ensure meaningful patient involvement in clinical projects.To understand the barriers and potential solutions from a patient's perspective, in order to meaningfully involve patients in clinical projects.

Reshaping clinical science: Introduction to the Special Issue on Psychophysiology and the NIMH Research Domain Criteria (RDoC) initiative.

PubMed

Patrick, Christopher J; Hajcak, Greg

2016-03-01

The National Institute of Mental Health's (NIMH) Research Domain Criteria (RDoC) initiative seeks to establish new dimensional conceptions of mental health problems, through the investigation of clinically relevant "process" constructs that have neurobiological as well as psychological referents. This special issue provides a detailed overview of the RDoC framework by NIMH officials Michael Kozak and Bruce Cuthbert, and spotlights RDoC-oriented investigative efforts by leading psychophysiological research groups as examples of how clinical science might be reshaped through application of RDoC principles. Accompanying commentaries highlight key aspects of the work by each group, and discuss reported methods/findings in relation to promises and challenges of the RDoC initiative more broadly. © 2016 Society for Psychophysiological Research.

Strategies to successfully recruit and engage clinical nurses as participants in qualitative clinical research.

PubMed

Coyne, Elisabeth; Grafton, Eileen; Reid, Alayne

2016-12-01

Research conducted in the clinical area promotes the delivery of evidence-based patient care. Involving nurses as participants in research is considered essential to link patient care with evidence-based interventions. However recruitment is influenced by nurses' competing demands and understanding engagement strategies may assist future research. This reflective analysis aimed to understand influencing factors and strategies that support successful recruitment nurses in clinical research. A reflective analysis of research notes and focus group data from research with oncology nurses was completed. This research identified that gaining support from key staff, understanding work constraints and developing a rapport with nurses is important. Establishing clear relevance and benefits of the research and being flexible with research requirements enabled nurses to participate in the research. Clear information and a willingness to accommodate the demands and dynamic nature of the environment, ensures ongoing support and engagement of nurses in the clinical setting as participants in research.

Getting (the most) out of the research business: interventions for youth with T1DM.

PubMed

Harris, Michael A; Freeman, Kurt A; Duke, Danny C

2010-12-01

We review research on psychosocial interventions to improve outcomes for youth with type 1 diabetes mellitus. Specifically, we discuss individual- and small group-focused, family-focused, group-focused, and other interventions. After reviewing extant research in each area, we discuss how the current evidence base may be used to inform clinical practice. Finally, we conclude by discussing variations in effects of interventions on different outcomes (eg, glycemic control, family functioning) and how to consider this evidence when selecting treatments to transport into clinical settings.

Observation for clinical effect of phellodendron wet compress in treating the phlebitis caused by infusion.

PubMed

Wan, Ying

2018-05-01

Aim of the study was to observe and analyze the clinical effect of phellodendron wet compress in treating the phlebitis caused by infusion. The research objects were 600 cases of phlebitis caused by infusion, all of which were treated in our hospital from June 2013 to June 2016. All patients were entitled to the right to know. They were randomly divided into the research group and the control group. Patients in the control group were treated with magnesium sulfate solution wet compress, while patients in the research group were treated with phellodendron wet compress. The effects in these two groups were observed and compared. Compared with the control group, the research group has better overall treatment efficiency, p<0.05; shorter average onset of action, p<0.05; less time in relieving red swelling and pain, p<0.05. Phellodendron wet compress shows a beneficial effect in treating the phlebitis caused by infusion. It can not only obviously shorten the onset of action, but also level up the overall treatment efficiency that helps patients to recover.

Educating Parents About Pediatric Research: Children and Clinical Studies Website Qualitative Evaluation.

PubMed

Marceau, Lisa D; Welch, Lisa C; Pemberton, Victoria L; Pearson, Gail D

2016-07-01

A gap in information about pediatric clinical trials exists, and parents remain uncertain about what is involved in research studies involving children. We aimed to understand parent perspectives about pediatric clinical research after viewing the online Children and Clinical Studies (CaCS) program. Using a qualitative descriptive study design, we conducted focus groups with parents and phone interviews with physicians. Three themes emerged providing approaches to improve parent's understanding of clinical research by including strategies where parents (a) hear from parents like themselves to learn about pediatric research, (b) receive general clinical research information to complement study-specific details, and (c) are provided more information about the role of healthy child volunteers. Parents found the website a valuable tool that would help them make a decision about what it means to participate in research. This tool can assist parents, providers, and researchers by connecting general information with study-specific information. © The Author(s) 2015.

Drug-resistant tuberculosis clinical trials: proposed core research definitions in adults.

PubMed

Furin, J; Alirol, E; Allen, E; Fielding, K; Merle, C; Abubakar, I; Andersen, J; Davies, G; Dheda, K; Diacon, A; Dooley, K E; Dravnice, G; Eisenach, K; Everitt, D; Ferstenberg, D; Goolam-Mahomed, A; Grobusch, M P; Gupta, R; Harausz, E; Harrington, M; Horsburgh, C R; Lienhardt, C; McNeeley, D; Mitnick, C D; Nachman, S; Nahid, P; Nunn, A J; Phillips, P; Rodriguez, C; Shah, S; Wells, C; Thomas-Nyang'wa, B; du Cros, P

2016-03-01

Drug-resistant tuberculosis (DR-TB) is a growing public health problem, and for the first time in decades, new drugs for the treatment of this disease have been developed. These new drugs have prompted strengthened efforts in DR-TB clinical trials research, and there are now multiple ongoing and planned DR-TB clinical trials. To facilitate comparability and maximise policy impact, a common set of core research definitions is needed, and this paper presents a core set of efficacy and safety definitions as well as other important considerations in DR-TB clinical trials work. To elaborate these definitions, a search of clinical trials registries, published manuscripts and conference proceedings was undertaken to identify groups conducting trials of new regimens for the treatment of DR-TB. Individuals from these groups developed the core set of definitions presented here. Further work is needed to validate and assess the utility of these definitions but they represent an important first step to ensure there is comparability in clinical trials on multidrug-resistant TB.

Structure of NCI Cooperative Groups Program Prior to NCTN

Cancer.gov

Learn how the National Cancer Institute’s Cooperative Groups Program was structured prior to its being replaced by NCI’s National Clinical Trials Network (NCTN). The NCTN gives funds and other support to cancer research organizations to conduct cancer clinical trials.

Mesothelioma and thymic tumors: Treatment challenges in (outside) a network setting.

PubMed

Imbimbo, Martina; Maury, Jean-Michel; Garassino, Marina; Girard, Nicolas

2018-02-02

The management of patients with mesothelioma and thymic malignancy requires continuous multidisciplinary expertise at any step of the disease. A dramatic improvement in our knowledge has occurred in the last few years, through the development of databases, translational research programs, and clinical trials. Access to innovative strategies represents a major challenge, as there is a lack of funding for clinical research in rare cancers and their rarity precludes the design of robust clinical trials that could lead to specific approval of drugs. In this context, patient-centered initiatives, such as the establishment of dedicated networks, are warranted. International societies, such as IMIG (International Mesothelioma Interest Group) and ITMIG (International Thymic Malignancy Interest Group) provide infrastructure for global collaboration, and there are many advantages to having strong regional groups working on the same issues. There may be regional differences in risk factors, susceptibility, management and outcomes. The ability to address questions both regionally as well as globally is ideal to develop a full understanding of mesothelioma and thymic malignancies. In Europe, through the integration of national networks with EURACAN, the collaboration with academic societies and international groups, the development of networks in thoracic oncology provides multiplex integration of clinical care and research, ultimately ensuring equal access to high quality care to all patients, with the opportunity of conducting high level clinical and translational research projects. Copyright © 2018 Elsevier Ltd, BASO ~ The Association for Cancer Surgery, and the European Society of Surgical Oncology. All rights reserved.

Internet-delivered treatment for older adults with anxiety and depression: implementation of the Wellbeing Plus Course in routine clinical care and comparison with research trial outcomes

PubMed Central

Staples, Lauren G.; Fogliati, Vincent J.; Dear, Blake F.; Nielssen, Olav

2016-01-01

Background The Wellbeing Plus Course is an internet-delivered psychological intervention for older adults with anxiety or depression. Aims To compare the effectiveness of the Wellbeing Plus Course in a public health setting (clinic group) with its efficacy in a randomised controlled trial (research group). Method Participants (n=949) were Australian adults aged 60 and above. Primary outcome measures were the Patient Health Questionnaire (PHQ-9) and Generalized Anxiety Disorder scale (GAD-7). Results Initial symptom severity was higher in the clinic group and course completion was lower. Both groups showed significant symptom reductions at post-treatment and were satisfied with the treatment. Results were maintained at 3-month follow-up. Within-group symptom changes were comparable between settings; there were no between-group differences on primary outcomes or satisfaction. Conclusions The Wellbeing Plus Course is as effective and acceptable in routine clinical care, as it is in controlled research trials. Declaration of interest N.T. and B.F.D developed the Wellbeing Plus Course but derived no financial benefit from it. Copyright and usage © The Royal College of Psychiatrists 2016. This is an open access article distributed under the terms of the Creative Commons Non-Commercial, No Derivatives (CC BY-NC-ND) license. PMID:27703794

Clinical Criteria Versus a Possible Research Case Definition in Chronic Fatigue Syndrome/Myalgic Encephalomyelitis

PubMed Central

Jason, Leonard A.; McManimen, Stephanie; Sunnquist, Madison; Newton, Julia L.; Strand, Elin Bolle

2017-01-01

Background The Institute of Medicine (IOM) recently developed clinical criteria for what had been known as chronic fatigue syndrome (CFS). Given the broad nature of the clinical IOM criteria, there is a need for a research definition that would select a more homogenous and impaired group of patients than the IOM clinical criteria. At the present time, it is unclear what will serve as the research definition. Purpose The current study focused on a research definition which selected homebound individuals who met the four IOM criteria, excluding medical and psychiatric co-morbidities. Methods Our research criteria were compared to those participants meeting the IOM criteria. Those not meeting either of these criteria sets were placed in a separate group defined by 6 or more months of fatigue. Data analyzed were from the DePaul Symptom Questionnaire and the SF-36. Due to unequal sample sizes and variances, Welch’s F tests and Games-Howell post hoc tests were conducted. Results Using a large database of over 1,000 patients from several countries, we found that those meeting a more restrictive research definition were even more impaired and more symptomatic than those meeting criteria for the other two groups. Conclusion Deciding on a particular research case definition would allow researchers to select more comparable patient samples across settings, and this would represent one of the most significant methodologic advances for this field of study. PMID:29062593

A case study of engaging hard-to-reach participants in the research process: Community Advisors on Research Design and Strategies (CARDS)®

PubMed Central

Kaiser, Betty L.; Thomas, Gay R.; Bowers, Barbara J.

2016-01-01

Lack of diversity among study participants in clinical research limits progress in eliminating health disparities. The engagement of lay stakeholders, such as patient or community advisory boards (CABs), has the potential to increase recruitment and retention of underrepresented groups by providing a structure for gathering feedback on research plans and materials from this target population. However, many CABs intentionally recruit prominent stakeholders who are connected to or comfortable with research and academia and thus may not accurately represent the perspectives of underrepresented groups who have been labeled hard-to-reach, including racial minorities and low-income or low-literacy populations. We developed a partnership between the University of Wisconsin-Madison School of Nursing and two community centers to deliberately engage hard-to-reach people in two lay advisory groups, the Community Advisors on Research Design and Strategies (CARDS)®. Community center staff recruited the CARDS® from center programs, including parenting and childcare programs, women’s support groups, food pantries, and senior meal programs. The CARDS® model differs from other CABs in its participants, processes, and outcomes. Since 2010, the CARDS® have met monthly with nurses and other researchers, helping them understand how research processes and the language, tone, appearance, and organization of research materials can discourage people from enrolling in clinical studies. We have successfully used the CARDS® model to bring hard-to-reach populations into the research process and have sustained their participation. The model represents a promising strategy for increasing the diversity of participants in clinical research. PMID:27686421

Academia, advocacy, and industry: a collaborative method for clinical research advancement.

PubMed

Vanzo, Rena J; Lortz, Amanda; Calhoun, Amy R U L; Carey, John C

2014-07-01

Professionals who work in academia, advocacy, and industry often carry out mutually exclusive activities related to research and clinical care. However, there are several examples of collaboration among such professionals that ultimately allows for improved scientific and clinical understanding. This commentary recounts our particular experience (a collaboration between geneticists at the Universities of Minnesota and Utah, the 4p- Support Group, and Lineagen, Inc) and reviews other similar projects. We formally propose this collaborative method as a conduit for future clinical research programs. Specifically, we encourage academicians, directors of family/advocacy/support groups, and members of industry to establish partnerships and document their experiences. The medical community as a whole will benefit from such partnerships and, specifically, families will teach us lessons that could never be learned in a laboratory or textbook. © 2014 Wiley Periodicals, Inc.

How to emerge from the conservatism in clinical research methodology?

PubMed

Kotecki, Nuria; Penel, Nicolas; Awada, Ahmad

2017-09-01

Despite recent changes in clinical research methodology, many challenges remain in drug development methodology. Advances in molecular biology and cancer treatments have changed the clinical research landscape. Thus, we moved from empirical clinical oncology to molecular and immunological therapeutic approaches. Along with this move, adapted dose-limiting toxicities definitions, endpoints, and dose escalation methods have been proposed. Moreover, the classical frontier between phase I, phase II, and phase III has become unclear in particular for immunological approaches. So, investigators are facing major challenges in drug development methodology. We propose to individualize clinical research using innovative approaches to significantly improve patient outcomes and targeting what is considered unmet need. Integrating high level of translational research and performing well designed biomarker studies with great potential for clinical practice are of utmost importance. This could be performed within new models of clinical research networks and by building a strong collaboration between academic, cooperative groups, on-site investigators, and pharma.

The Dutch Pancreas Biobank Within the Parelsnoer Institute: A Nationwide Biobank of Pancreatic and Periampullary Diseases.

PubMed

Strijker, Marin; Gerritsen, Arja; van Hilst, Jony; Bijlsma, Maarten F; Bonsing, Bert A; Brosens, Lodewijk A; Bruno, Marco J; van Dam, Ronald M; Dijk, Frederike; van Eijck, Casper H; Farina Sarasqueta, Arantza; Fockens, Paul; Gerhards, Michael F; Groot Koerkamp, Bas; van der Harst, Erwin; de Hingh, Ignace H; van Hooft, Jeanin E; Huysentruyt, Clément J; Kazemier, Geert; Klaase, Joost M; van Laarhoven, Cornelis J; van Laarhoven, Hanneke W; Liem, Mike S; de Meijer, Vincent E; van Rijssen, L Bengt; van Santvoort, Hjalmar C; Suker, Mustafa; Verhagen, Judith H; Verheij, Joanne; Verspaget, Hein W; Wennink, Roos A; Wilmink, Johanna W; Molenaar, I Quintus; Boermeester, Marja A; Busch, Olivier R; Besselink, Marc G

2018-04-01

Large biobanks with uniform collection of biomaterials and associated clinical data are essential for translational research. The Netherlands has traditionally been well organized in multicenter clinical research on pancreatic diseases, including the nationwide multidisciplinary Dutch Pancreatic Cancer Group and Dutch Pancreatitis Study Group. To enable high-quality translational research on pancreatic and periampullary diseases, these groups established the Dutch Pancreas Biobank. The Dutch Pancreas Biobank is part of the Parelsnoer Institute and involves all 8 Dutch university medical centers and 5 nonacademic hospitals. Adult patients undergoing pancreatic surgery (all indications) are eligible for inclusion. Preoperative blood samples, tumor tissue from resected specimens, pancreatic cyst fluid, and follow-up blood samples are collected. Clinical parameters are collected in conjunction with the mandatory Dutch Pancreatic Cancer Audit. Between January 2015 and May 2017, 488 patients were included in the first 5 participating centers: 4 university medical centers and 1 nonacademic hospital. Over 2500 samples were collected: 1308 preoperative blood samples, 864 tissue samples, and 366 follow-up blood samples. Prospective collection of biomaterials and associated clinical data has started in the Dutch Pancreas Biobank. Subsequent translational research will aim to improve treatment decisions based on disease characteristics.

Culturally and Linguistically Diverse Populations in Medical Research: Perceptions and Experiences of Older Italians, Their Families, Ethics Administrators and Researchers

PubMed Central

Woodward-Kron, Robyn; Hughson, Jo-anne; Parker, Anna; Bresin, Agnese; Hajek, John; Knoch, Ute; Phan, Tuong Dien; Story, David

2016-01-01

Background Low-participation of culturally and linguistically diverse (CALD) patients in medical research remains a problem in migrant and refugee destination countries such as Australia. The aims of this study were to explore i) CALD persons’ perceptions and experiences of the medical system and medical research, in this case, older Italian Australians; and ii) the views of research professionals on CALD patient participation in medical research. Design and Methods A qualitative study was conducted in Melbourne, Australia, in 2015 utilising in-depth interviews and focus groups with four stakeholder groups: older Italian Australians (n=21); adult children of older Italian Australians (n=10); hospital Human Research Ethics Committee administrators (n=4); and clinical researchers (n=4). The data were analysed for content and thematic analysis. Results Themes for the CALD and family group were getting by in medical interactions; receptivity to medical research: testing the waters; and, receptivity to technology for support: passive versus active. Themes for the researcher and HREC groups about CALD patient participation in research were: exclusion; cultural factors; and e-consent. Conclusions Our findings from four stakeholder perspectives and experiences confirm that there were considerable cultural, linguistic, and resourcing barriers hindering the participation of older Italian-Australians in medical research. Furthermore, our findings showed that in this study setting there were few enabling strategies in place to address these barriers despite the national ethics guidelines for equitable participation in research. The findings informed the creation of a multimedia tool whose purpose is to address and improve representation of CALD groups in clinical research. Significance for public health Many people from culturally and linguistically diverse (CALD) backgrounds remain excluded from medical research such as clinical trials due to a range of language and cultural factors that can be amplified when this population is ageing. This exclusion has implications for the ability of CALD populations to benefit from participating in medical research and for applying research findings to CALD populations. It is essential to develop and implement strategies to include CALD communities in medical research and to uphold the ethical obligation of obtaining informed consent to research. The findings of this study have guided the development of a tablet-based resource which can be used in clinical and community contexts to raise awareness about the purpose of medical research. The resource has been carefully designed to be appropriate for participants' cultural background as well as their preferred language and literacy level. Such a resource has potential to address some of the cultural and linguistic barriers to clinical trial participation of CALD populations. PMID:27190978

Benefits and Risks in Secondary Use of Digitized Clinical Data: Views of Community Members Living in a Predominantly Ethnic Minority Urban Neighborhood

PubMed Central

Lucero, Robert J.; Kearney, Joan; Cortes, Yamnia; Arcia, Adriana; Appelbaum, Paul; Fernández, Roberto Lewis; Luchsinger, Jose

2015-01-01

Background There is potential to increase the speed of scientific discovery and implement personalized health care by using digitized clinical data collected on the patient care experience. The use of these data in research raises concerns about the privacy and confidentiality of personal health information. This study explored community members’ views on the secondary use of digitized clinical data to (1) recruit participants for clinical studies; (2) recruit family members of persons with an index condition for primary studies; and (3) conduct studies of information related to stored biospecimens. Methods A qualitative descriptive design was used to examine the bioethical issues outlined from the perspective of urban-dwelling community members. Focus groups were used for data collection, and emergent content analysis was employed to organize and interpret the data. Results Thirty community members attended one of four focus groups ranging in size from 4 to 11 participants. Five critical themes emerged from the focus-group material: (1) perceived motivators for research participation; (2) objective or “real-life” barriers to research participation; (3) a psychological component of uncertainty and mistrust; (4) preferred mechanisms for recruitment and participation; and (5) cultural characteristics that can impact understanding and willingness to engage in research. Conclusions The overriding concern of community members regarding research participation and/or secondary clinical and nonclinical use of digitized information was that their involvement would be safe and the outcome would be meaningful to them and to others. According to participants, biospecimens acquired during routine clinical visits or for research are no longer possessions of the participant. Although the loss of privacy was a concern for participants, they preferred that researchers access their personal health information using a digitized clinical file rather than through a paper-based medical record. PMID:26101782

Incidence of Osteoporosis in Patients with Urolithiasis

PubMed Central

Bijelic, Radojka; Milicevic, Snjezana; Balaban, Jagoda

2014-01-01

ABSTRACT Introduction. Clinical researches have shown an increased bone disintegration and lower bone mass in patients with calcium urolithiasis. Goal. The goal of our research was to establish the incidence of osteoporosis in adult patients with calcium urolithiasis, on the basis of measuring mineral bone density, using DEXA method, with a special reflection on age subgroups. Material and methods. Clinical research was prospective and it was implemented at the University Clinical Center of Banja Luka, at the Clinic for Endocrinology, Diabetes and Metabolic Diseases and at the Urology Clinic. Material in this research consisted of patients divided in two groups, a working and a control group. One hundred and twenty (120) patients were included in both these groups, divided in three age subgroups: 20-40, 40-60 and over 60. The working group consisted of the patients with calcium urolithiasis and the control group consisted of patients without calcium urolithiasis. Establishing of mineral bone density at L2-L4 of lumbal spine vertebrae and hip was done for the patients in both these groups, using DEXA method. Results. Analysis of mineral bone density using DEXA method in patients in age groups of working and control groups, as well as in the total sample of working and control groups, have shown that the patients of the working group, over 60, had a decreased mineral bone density (30% of osteopenia and 15% osteoporosis) significantly more expressed when compared to the other two age groups (12.5% in the subgroup 20-40 and 17.5% in the subgroup 40-60), which presents a statistically significant difference (p<0.05). In the control group, when taking into account age groups, osteopenia and osteoporosis were marked in 37.5% and 2.5% in the group of patients over 60, whereas in the youngest population, 5% of osteopenia was found, which presents a statistically significant difference (p<0.05). When observing the total sample of working and control group, there was a statistically significant difference in the working and control group (p<0.01); incidence of osteoporosis in the working group amounted to 7.5% and in the control group it was 0.8%. Conclusion. Urolithiasis and osteoporosis are two multifactorial diseases which are evidently reciprocal. This is why we suggest that educating the population about the risk factors for occurrence of these diseases as well as preventive measures that may contribute to their decrease should begin as early as possible. PMID:25568567

Predicting medical school and internship success: does the quality of the research and clinical experience matter?

PubMed

Paolino, Nathalie D; Artino, Anthony R; Saguil, Aaron; Dong, Ting; Durning, Steven J; DeZee, Kent J

2015-04-01

This article explores specific aspects of self-reported clinical and research experience and their relationship to performance in medical training. This is a retrospective cohort study conducted at the Uniformed Services University. The American Medical College Application Service application was used to discern students' self-reported clinical and research experience. Two authors applied a classification scheme for clinical and research experience to the self-reported experiences. Study outcomes included medical school grade point average (GPA), U.S. Medical Licensing Examination (USMLE) scores, and intern expertise and professionalism scores. A linear regression analysis was conducted for each outcome while controlling for prematriculation GPA. Data were retrieved on 1,020 matriculants. There were several statistically significant but small differences across outcomes when comparing the various categories of clinical experience with no clinical experience. The technician-level experience group had a decrease of 0.1 in cumulative GPA in comparison to students without self-reported clinical experience (p = 0.004). This group also performed 5 points lower on the USMLE Step 2 than students who did not report clinical experience (p = 0.013). The various levels of self-reported research experience were unrelated to success in medical school and graduate medical education. These findings indicate that self-reported technician-level clinical experience is related to a small reduction in typically reported outcomes in medical school. Reprint & Copyright © 2015 Association of Military Surgeons of the U.S.

Development of an open metadata schema for prospective clinical research (openPCR) in China.

PubMed

Xu, W; Guan, Z; Sun, J; Wang, Z; Geng, Y

2014-01-01

In China, deployment of electronic data capture (EDC) and clinical data management system (CDMS) for clinical research (CR) is in its very early stage, and about 90% of clinical studies collected and submitted clinical data manually. This work aims to build an open metadata schema for Prospective Clinical Research (openPCR) in China based on openEHR archetypes, in order to help Chinese researchers easily create specific data entry templates for registration, study design and clinical data collection. Singapore Framework for Dublin Core Application Profiles (DCAP) is used to develop openPCR and four steps such as defining the core functional requirements and deducing the core metadata items, developing archetype models, defining metadata terms and creating archetype records, and finally developing implementation syntax are followed. The core functional requirements are divided into three categories: requirements for research registration, requirements for trial design, and requirements for case report form (CRF). 74 metadata items are identified and their Chinese authority names are created. The minimum metadata set of openPCR includes 3 documents, 6 sections, 26 top level data groups, 32 lower data groups and 74 data elements. The top level container in openPCR is composed of public document, internal document and clinical document archetypes. A hierarchical structure of openPCR is established according to Data Structure of Electronic Health Record Architecture and Data Standard of China (Chinese EHR Standard). Metadata attributes are grouped into six parts: identification, definition, representation, relation, usage guides, and administration. OpenPCR is an open metadata schema based on research registration standards, standards of the Clinical Data Interchange Standards Consortium (CDISC) and Chinese healthcare related standards, and is to be publicly available throughout China. It considers future integration of EHR and CR by adopting data structure and data terms in Chinese EHR Standard. Archetypes in openPCR are modularity models and can be separated, recombined, and reused. The authors recommend that the method to develop openPCR can be referenced by other countries when designing metadata schema of clinical research. In the next steps, openPCR should be used in a number of CR projects to test its applicability and to continuously improve its coverage. Besides, metadata schema for research protocol can be developed to structurize and standardize protocol, and syntactical interoperability of openPCR with other related standards can be considered.

Pulmonary exacerbation in adults with bronchiectasis: a consensus definition for clinical research.

PubMed

Hill, Adam T; Haworth, Charles S; Aliberti, Stefano; Barker, Alan; Blasi, Francesco; Boersma, Wim; Chalmers, James D; De Soyza, Anthony; Dimakou, Katerina; Elborn, J Stuart; Feldman, Charles; Flume, Patrick; Goeminne, Pieter C; Loebinger, Michael R; Menendez, Rosario; Morgan, Lucy; Murris, Marlene; Polverino, Eva; Quittner, Alexandra; Ringshausen, Felix C; Tino, Gregory; Torres, Antoni; Vendrell, Montserrat; Welte, Tobias; Wilson, Rob; Wong, Conroy; O'Donnell, Anne; Aksamit, Timothy

2017-06-01

There is a need for a clear definition of exacerbations used in clinical trials in patients with bronchiectasis. An expert conference was convened to develop a consensus definition of an exacerbation for use in clinical research.A systematic review of exacerbation definitions used in clinical trials from January 2000 until December 2015 and involving adults with bronchiectasis was conducted. A Delphi process followed by a round-table meeting involving bronchiectasis experts was organised to reach a consensus definition. These experts came from Europe (representing the European Multicentre Bronchiectasis Research Collaboration), North America (representing the US Bronchiectasis Research Registry/COPD Foundation), Australasia and South Africa.The definition was unanimously approved by the working group as: a person with bronchiectasis with a deterioration in three or more of the following key symptoms for at least 48 h: cough; sputum volume and/or consistency; sputum purulence; breathlessness and/or exercise tolerance; fatigue and/or malaise; haemoptysis AND a clinician determines that a change in bronchiectasis treatment is required.The working group proposes the use of this consensus-based definition for bronchiectasis exacerbation in future clinical research involving adults with bronchiectasis. Copyright ©ERS 2017.

Challenging Assumptions About Minority Participation in US Clinical Research

PubMed Central

Kalbaugh, Corey A.

2011-01-01

Although extensive research addresses minorities’ low participation in clinical research, most focuses almost exclusively on therapeutic trials. The existing literature might mask important issues concerning minorities’ participation in clinical trials, and minorities might actually be overrepresented in phase I safety studies that require the participation of healthy volunteers. It is critical to consider the entire spectrum of clinical research when discussing the participation of disenfranchised groups; the literature on minorities’ distrust, poor access, and other barriers to trial participation needs reexamination. Minority participation in clinical trials is an important topic in public health discussions because this representation touches on issues of equality and the elimination of disparities, which are core values of the field. PMID:22021285

Data governance requirements for distributed clinical research networks: triangulating perspectives of diverse stakeholders.

PubMed

Kim, Katherine K; Browe, Dennis K; Logan, Holly C; Holm, Roberta; Hack, Lori; Ohno-Machado, Lucila

2014-01-01

There is currently limited information on best practices for the development of governance requirements for distributed research networks (DRNs), an emerging model that promotes clinical data reuse and improves timeliness of comparative effectiveness research. Much of the existing information is based on a single type of stakeholder such as researchers or administrators. This paper reports on a triangulated approach to developing DRN data governance requirements based on a combination of policy analysis with experts, interviews with institutional leaders, and patient focus groups. This approach is illustrated with an example from the Scalable National Network for Effectiveness Research, which resulted in 91 requirements. These requirements were analyzed against the Fair Information Practice Principles (FIPPs) and Health Insurance Portability and Accountability Act (HIPAA) protected versus non-protected health information. The requirements addressed all FIPPs, showing how a DRN's technical infrastructure is able to fulfill HIPAA regulations, protect privacy, and provide a trustworthy platform for research. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

GaitaBase: Web-based repository system for gait analysis.

PubMed

Tirosh, Oren; Baker, Richard; McGinley, Jenny

2010-02-01

The need to share gait analysis data to improve clinical decision support has been recognised since the early 1990s. GaitaBase has been established to provide a web-accessible repository system of gait analysis data to improve the sharing of data across local and international clinical and research community. It is used by several clinical and research groups across the world providing cross-group access permissions to retrieve and analyse the data. The system is useful for bench-marking and quality assurance, clinical consultation, and collaborative research. It has the capacity to increase the population sample size and improve the quality of 'normative' gait data. In addition the accumulated stored data may facilitate clinicians in comparing their own gait data with others, and give a valuable insight into how effective specific interventions have been for others. 2009 Elsevier Ltd. All rights reserved.

Overview of the Oral HIV/AIDS Research Alliance Program

PubMed Central

Shiboski, C.H.; Webster-Cyriaque, J.Y.; Ghannoum, M.; Greenspan, J.S.; Dittmer, D.

2011-01-01

The Oral HIV/AIDS Research Alliance is part of the AIDS Clinical Trials Group, the largest HIV clinical trial organization in the world, and it is funded by the National Institute of Dental and Craniofacial Research, in collaboration with the National Institute of Allergy and Infectious Diseases. The alliance’s main objective is to investigate the oral complications associated with HIV/AIDS as the epidemic is evolving—in particular, the effects of potent antiretrovirals on the development of oral mucosal lesions and associated fungal and viral pathogens. Furthermore, oral fluids are being explored for their potential monitoring and diagnostic role with respect to HIV disease and coinfections. This article presents an overview of the alliance, its scientific agenda, and an outline of the novel interventional and noninterventional clinical studies ongoing and developing within the AIDS Clinical Trials Group infrastructure in the United States and internationally. PMID:21441477

Overview of the oral HIV/AIDS Research Alliance Program.

PubMed

Shiboski, C H; Webster-Cyriaque, J Y; Ghannoum, M; Greenspan, J S; Dittmer, D

2011-04-01

The Oral HIV/AIDS Research Alliance is part of the AIDS Clinical Trials Group, the largest HIV clinical trial organization in the world, and it is funded by the National Institute of Dental and Craniofacial Research, in collaboration with the National Institute of Allergy and Infectious Diseases. The alliance's main objective is to investigate the oral complications associated with HIV/AIDS as the epidemic is evolving-in particular, the effects of potent antiretrovirals on the development of oral mucosal lesions and associated fungal and viral pathogens. Furthermore, oral fluids are being explored for their potential monitoring and diagnostic role with respect to HIV disease and coinfections. This article presents an overview of the alliance, its scientific agenda, and an outline of the novel interventional and noninterventional clinical studies ongoing and developing within the AIDS Clinical Trials Group infrastructure in the United States and internationally.

Research awareness, attitudes and barriers among clinical staff in a regional cancer centre. Part 1: a quantitative analysis.

PubMed

Caldwell, B; Coltart, K; Hutchison, C; McJury, M; Morrison, A; Paterson, C; Thomson, M

2017-09-01

Research is of key importance in delivering high-quality patient care through evidence-based practice. Attitude towards research and barriers to research can have an impact on research activity. A survey was conducted to establish the levels of research awareness and attitudes among clinical staff groups in this regional cancer centre and identify any barriers to participation in research. The survey consisted of 26 questions and was distributed electronically and completed online. The response rate was 22.3% (n = 123). All participants felt that clinical research will help the regional cancer centre develop and progress treatments in the future. A positive attitude towards research was evident and consistent across professional groups. The main identified barriers to research included lacking the required knowledge, skills and training, lacking support from managers, and lack of opportunity or time to be involved in research, in particular for allied health professionals. However, there appears to be the foundation of a healthy research culture for nurses supported by management. The results of the survey support the implementation of an action plan based on the recommendations of this journal article. © 2016 John Wiley & Sons Ltd.

Chinese lupus treatment and research group (CSTAR) registry: X. family history in relation to lupus clinical and immunological manifestations.

PubMed

Leng, Xiaomei; Li, Mengtao; Li, Xiangpei; Zhang, Xiao; Liu, Shengyun; Wu, Lijun; Ma, Li; Bi, Liqi; Zuo, Xiaoxia; Sun, Lingyun; Huang, Cibo; Zhao, Jiuliang; Zhao, Yan; Zeng, Xiaofeng

2018-01-01

This study aimed to examine the associations between family history and clinical manifestations and immunologic characteristics of lupus in China. Based on their family history, lupus patients from the Chinese lupus treatment and research group (CSTAR) registry were categorised: familial lupus (FL), family history of other rheumatic disorders (RD), and sporadic lupus (SL). Demographic data, clinical manifestations, and laboratory data were compared among these three groups. A total of 2,104 patients from CSTAR were included, with 34 (1.6%) in the FL group, 50 (2.4%) in the RD group, and 2,020 (96.0%) in the SL group. There were no significant differences in age or gender among these groups (p=0.36 and p=0.75, respectively). The prevalence of discoid rash and positivity of anti-RNP antibodies differed significantly among the three groups. Photosensitivity and neurological disorder were marginally significantly different among the three groups (p=0.05). No statistical differences were observed in other clinical manifestations or laboratory results. In the FL group, first-degree relatives (25/34, 73.5%) had higher susceptibility to lupus. Rheumatoid arthritis (RA) (35/50, 70.0%) was the most frequent non-lupus rheumatic disorder in the RD group. Among lupus patients, the rate of familial lupus was lower in Chinese patients than among other ethnicities. Familial lupus cases are found mainly among their first-degree relatives. A family history of lupus did not significantly affect clinical phenotypes, except for higher frequency of discoid rash and anti-RNP in the FL group, and more anti-RNP positivity in the RD group.

Impact of the European clinical trials directive on prospective academic clinical trials associated with BMT.

PubMed

Frewer, L J; Coles, D; van der Lans, I A; Schroeder, D; Champion, K; Apperley, J F

2011-03-01

The European Clinical Trials Directive (EU 2001; 2001/20/EC) was introduced to improve the efficiency of commercial and academic clinical trials. Concerns have been raised by interested organizations and institutions regarding the potential for negative impact of the Directive on non-commercial European clinical research. Interested researchers within the European Group for Blood and Marrow Transplantation (EBMT) were surveyed to determine whether researcher experiences confirmed this view. Following a pilot study, an internet-based questionnaire was distributed to individuals in key research positions in the European haemopoietic SCT community. Seventy-one usable questionnaires were returned from participants in different EU member states. The results indicate that the perceived impact of the European Clinical Trials Directive has been negative, at least in the research areas of interest to the EBMT.

Indications of Recruitment Challenges in Research with U.S. Military Service Members: A ClinicalTrials.gov Review.

PubMed

Cook, Wendy A; Doorenbos, Ardith Z

2017-03-01

The success of military-relevant health research often depends on recruiting adequate numbers of U.S. military service members as research participants. Researchers have reported difficulties in recruiting service member research participants. Reviews of ClinicalTrials.gov, an online clinical trial registry of publicly and privately sponsored studies, have identified challenges in participant recruitment and barriers to study completion in various research populations. The purpose of this study was to identify indications of difficulty recruiting U.S. military service members as research participants based on data from study records in ClinicalTrials.gov. Records of studies starting between 2005 and 2014 were collected from ClinicalTrials.gov and updated through January 2016. Three hundred and two studies that included ≥25% U.S. military service member research participants were (1) compared to a comparison group of 302 studies, each with <5% service member participants and (2) compared by the proportion of service member participants within studies in the military group ("many" ≥25% but <100% service members and "all" 100% service members). Groups were evaluated and compared for recruitment status; reasons for study withdrawal, termination, or suspension; achievement of ≥85% of the anticipated enrollment; and differences in achieving recruitment goals according to study sponsor. Twelve percent of studies in the military group had been withdrawn, terminated, or suspended; enrollment and funding problems were the most common reasons. The comparison group had 11% of studies withdrawn, terminated, or suspended; the most common reasons were enrollment problems and sponsor decision. All study groups had indications of difficulty adequately achieving participant enrollment goals. Among studies with known anticipated and actual enrollment, approximately half in both the military group (47.9%) and comparison group (50.3%) achieved ≥85% of the anticipated enrollment (p = 0.722). Half of studies with many service members and 44% of studies with all service members achieved ≥85% of the anticipated enrollment (p = 0.600). In comparing the many and all service member subgroups, significant differences were found in the median values for anticipated enrollment and actual enrollment, even when accounting for Bonferroni correction. Evaluations of mean values did not show a statistical difference between the military subgroups. There were no significant differences according to study sponsor (military, academic, Veterans Affairs, National Institutes of Health, nonprofit organization, or industry) for a study achieving or not achieving ≥85% of the anticipated enrollment. This review supports anecdotal reports of difficulty recruiting service members as research participants. However, the findings also indicate that in many regards, there is not much difference in the difficulties recruiting service members versus other research participants. Findings suggest that it is often difficult to recruit research participants regardless of the specific population or type of study sponsor, and that studies with either many or all service member participants have similar achievement of recruitment goals. Findings in this study may be useful for those who design research that includes service members or for those who are apprehensive about including service members in their research. Reprint & Copyright © 2017 Association of Military Surgeons of the U.S.

A new diagnosis grouping system for child emergency department visits.

PubMed

Alessandrini, Evaline A; Alpern, Elizabeth R; Chamberlain, James M; Shea, Judy A; Gorelick, Marc H

2010-02-01

A clinically sensible system of grouping diseases is needed for describing pediatric emergency diagnoses for research and reporting. This project aimed to create an International Classification of Diseases (ICD)-based diagnosis grouping system (DGS) for child emergency department (ED) visits that is 1) clinically sensible with regard to how diagnoses are grouped and 2) comprehensive in accounting for nearly all diagnoses (>95%). The second objective was to assess the construct validity of the DGS by examining variation in the frequency of targeted groups of diagnoses within the concepts of season, age, sex, and hospital type. A panel of general and pediatric emergency physicians used the nominal group technique and Delphi surveys to create the DGS. The primary data source used to develop the DGS was the Pediatric Emergency Care Applied Research Network (PECARN) Core Data Project (PCDP). A total of 3,041 ICD-9 codes, accounting for 98.9% of all diagnoses in the PCDP, served as the basis for creation of the DGS. The expert panel developed a DGS framework representing a clinical approach to the diagnosis and treatment of pediatric emergency patients. The resulting DGS has 21 major groups and 77 subgroups and accounts for 96.5% to 99% of diagnoses when applied to three external data sets. Variations in the frequency of targeted groups of diagnoses related to seasonality, age, sex, and site of care confirm construct validity. The DGS offers a clinically sensible method for describing pediatric ED visits by grouping ICD-9 codes in a consensus-derived classification scheme. This system may be used for research, reporting, needs assessment, and resource planning. (c) 2010 by the Society for Academic Emergency Medicine.

A Case Study of Engaging Hard-to-Reach Participants in the Research Process: Community Advisors on Research Design and Strategies (CARDS)®.

PubMed

Kaiser, Betty L; Thomas, Gay R; Bowers, Barbara J

2017-02-01

Lack of diversity among study participants in clinical research limits progress in eliminating health disparities. The engagement of lay stakeholders, such as patient or community advisory boards (CABs), has the potential to increase recruitment and retention of underrepresented groups by providing a structure for gathering feedback on research plans and materials from this target population. However, many CABs intentionally recruit prominent stakeholders who are connected to or comfortable with research and academia and thus may not accurately represent the perspectives of underrepresented groups who have been labeled hard-to-reach, including racial minorities and low-income or low-literacy populations. We developed a partnership between the University of Wisconsin-Madison School of Nursing and two community centers to deliberately engage hard-to-reach people in two lay advisory groups, the Community Advisors on Research Design and Strategies (CARDS)®. Community center staff recruited the CARDS from center programs, including parenting and childcare programs, women's support groups, food pantries, and senior meal programs. The CARDS model differs from other CABs in its participants, processes, and outcomes. Since 2010, the CARDS have met monthly with nurses and other researchers, helping them understand how research processes and the language, tone, appearance, and organization of research materials can discourage people from enrolling in clinical studies. We have successfully used the CARDS model to bring hard-to-reach populations into the research process and have sustained their participation. The model represents a promising strategy for increasing the diversity of participants in clinical research. © 2016 Wiley Periodicals, Inc. © 2016 Wiley Periodicals, Inc.

Practical aspects of recruitment and retention in clinical trials of rare genetic diseases: the phenylketonuria (PKU) experience.

PubMed

DeWard, Stephanie J; Wilson, Ashley; Bausell, Heather; Volz, Ashley S; Mooney, Kimberly

2014-02-01

Bringing treatments for rare genetic diseases to patients requires clinical research. Despite increasing activism from patient support and advocacy groups to increase access to clinical research studies, connecting rare disease patients with the clinical research opportunities that may help them has proven challenging. Chief among these challenges are the low incidence of these diseases resulting in a very small pool of known patients with a particular disease, difficulty of diagnosing rare genetic diseases, logistical issues such as long distances to the nearest treatment center, and substantial disease burden leading to loss of independence. Using clinical studies of phenylketonuria as an example, this paper discusses how, based on the authors' collective experience, partnership among clinicians, patients, study coordinators, genetic counselors, dietitians, industry, patient support groups, and families can help overcome the challenges of recruiting and retaining patients in rare disease clinical trials. We discuss specific methods of collaboration, communication, and education as part of a long-term effort to build a community committed to advancing the medical care of patients with rare genetic diseases. By talking to patients and families regularly about research initiatives and taking steps to make study participation as easy as possible, rare disease clinic staff can help ensure adequate study enrollment and successful study completion.

A Randomized Controlled Study of Mind-Body Skills Groups for Treatment of War-Zone Stress in Military and Veteran Populations

DTIC Science & Technology

2010-10-01

of meditation, guided imagery, and breathing techniques; self-expression through words, drawings and movement; autogenic training and biofeedback...facilitating the mind-body skills group intervention have co-facilitated groups under the supervision of the clinical director and are fully trained ...exclusion criteria by the research coordinator. 2. The clinical director will supervise the trained group leaders who will be facilitating the mind

How we implemented an analytical support clinic to strengthen student research capacity in Zambia.

PubMed

Andrews, Ben; Musonda, Patrick; Simuyemba, Moses; Wilson, Craig M; Nzala, Selestine; Vermund, Sten H; Michelo, Charles

2014-12-11

Abstract Background: Research outputs in sub-Saharan Africa may be limited by a scarcity of clinical research expertise. In Zambia, clinical and biomedical postgraduate students are often delayed in graduation due to challenges in completing their research dissertations. We sought to strengthen institutional research capacity by supporting student and faculty researchers through weekly epidemiology and biostatistics clinics. Methods: We instituted a weekly Analytical Support Clinic at the University of Zambia, School of Medicine. A combination of biostatisticians, clinical researchers and epidemiologists meet weekly with clients to address questions of proposal development, data management and analysis. Clinic sign-in sheets were reviewed. Results: 109 students and faculty members accounted for 197 visits to the Clinic. Nearly all clients (107/109, 98.2%) were undergraduate or postgraduate students. Reasons for attending the Clinic were primarily for proposal development (46.7%) and data management/analysis (42.1%). The most common specific reasons for seeking help were data analysis and interpretation (36.5%), development of study design and research questions (26.9%) and sample size calculation (21.8%). Conclusions: The Analytical Support Clinic is an important vehicle for strengthening postgraduate research through one-on-one and small group demand-driven interactions. The clinic approach supplements mentorship from departmental supervisors, providing specific expertise and contextual teaching.

Genetics Home Reference: eosinophil peroxidase deficiency

MedlinePlus

... an Eosinophil? International Eosinophil Society, Inc.: Patient Support Groups Rare Disease Clinical Research Network: Consortium of Eosinophil Gastrointestinal Disease Researchers Scientific Articles ...

Mechanisms of change in control group drinking in clinical trials of brief alcohol intervention: implications for bias toward the null.

PubMed

Bernstein, Judith A; Bernstein, Edward; Heeren, Timothy C

2010-09-01

Reductions in control group consumption over time that are possibly related to research design affect the impact of brief alcohol interventions (BAI) in clinical settings. We conducted a systematic review to identify research design factors that may contribute to control group change, strategies to limit these effects and implications for researchers. Studies with control group n > 30 were selected if they published baseline and outcome consumption data, conducted trials in clinical settings in Anglophone countries and did not censor gender or age. Among 38 studies cited in 20 reviews through October 2009, 16 met criteria (n = 31-370). In 54%, controls received alcohol specific handouts, advice and/or referral. Both the number and depth of assessments were highly variable. The percentage change in consumption ranged from-0.10 to-0.84 (mean-0.32), and effect size from 0.04 to 0.70 (mean 0.37). Published data were insufficient for meta-analysis. Researchers should consider strategies to reduce the impact of research design factors, such as procedures to enhance sample diversity, blind subjects to study purpose to limit social desirability bias, reduce the number and depth of instruments (assessment reactivity), and finally, analytic techniques to decrease the impact of outliers and regression to the mean. This review identifies problems with retrospective analysis of predictors of control group change, and underscores the need to design prospective studies to permit identification, quantification and adjustment for potential sources of bias in BAI trials.

Clinical Natural Language Processing in languages other than English: opportunities and challenges.

PubMed

Névéol, Aurélie; Dalianis, Hercules; Velupillai, Sumithra; Savova, Guergana; Zweigenbaum, Pierre

2018-03-30

Natural language processing applied to clinical text or aimed at a clinical outcome has been thriving in recent years. This paper offers the first broad overview of clinical Natural Language Processing (NLP) for languages other than English. Recent studies are summarized to offer insights and outline opportunities in this area. We envision three groups of intended readers: (1) NLP researchers leveraging experience gained in other languages, (2) NLP researchers faced with establishing clinical text processing in a language other than English, and (3) clinical informatics researchers and practitioners looking for resources in their languages in order to apply NLP techniques and tools to clinical practice and/or investigation. We review work in clinical NLP in languages other than English. We classify these studies into three groups: (i) studies describing the development of new NLP systems or components de novo, (ii) studies describing the adaptation of NLP architectures developed for English to another language, and (iii) studies focusing on a particular clinical application. We show the advantages and drawbacks of each method, and highlight the appropriate application context. Finally, we identify major challenges and opportunities that will affect the impact of NLP on clinical practice and public health studies in a context that encompasses English as well as other languages.

Psychodynamic group psychotherapy: impact of group length and therapist professional characteristics on development of therapeutic alliance.

PubMed

Lorentzen, Steinar; Bakali, Jan Vegard; Hersoug, Anne Grete; Hagtvet, Knut A; Ruud, Torleif; Høglend, Per

2012-09-01

Little research has been done on therapeutic alliance in group psychotherapy, especially the impact of treatment duration and therapist professional characteristics. Therapeutic alliance was rated by patients on the Working Alliance Inventory-Short Form at three time points (sessions 3, 10 and 17) in a randomized controlled trial of short-term and long-term psychodynamic group psychotherapy. As predictors we selected therapist clinical experience and length of didactic training, which have demonstrated ambiguous results in previous research. Linear latent variable growth curve models (structural equation modeling) were developed for the three Working Alliance Inventory-Short Form subscales bond, task and goal. We found a significant variance in individual growth curves (intercepts and slopes) but no differential development due to group length. Longer therapist formal training had a negative impact on early values of subscale task in both treatments. There was an interaction between length of the therapists' clinical experience and group length on early bond, task and goal: therapists with longer clinical experience were rated lower on initial bond in the long-term group but less so in the short-term group. Longer clinical experience influenced initial task and goal positively in the short-term group but was unimportant for task or significantly negative for goal in the long-term group. There was no mean development of alliance, and group length did not differentially impact the alliance during 6 months. Early ratings of the three Working Alliance Inventory-Short Form subscales partly reflected different preparations of patients in the two group formats, partly therapist characteristics, but more research is needed to see how these aspects impact alliance development and outcome. Therapists should pay attention to all three aspects of the alliance, when they prepare patients for group therapy. In psychodynamic groups, length of therapy does not differentiate the overall level or the development of member-leader alliance. Within psychodynamic groups, each individual appear to have their unique perception of the member-leader alliance. Therapists with longer formal psychotherapy training may be less successful in establishing early agreement with patients on the tasks of psychodynamic group psychotherapy. Patients perceive a somewhat lower degree of early emotional bonding with the more clinically experienced therapists in long-term psychodynamics groups. Therapists with more clinical experience may contribute to a stronger degree of initial agreement with patients on the tasks and goals of short-term group psychotherapy. Copyright © 2011 John Wiley & Sons, Ltd.

Sleep disturbances and cognitive decline: recommendations on clinical assessment and the management.

PubMed

Guarnieri, Biancamaria; Cerroni, Gianluigi; Sorbi, Sandro

2015-01-01

In 2004, in Genoa (Italy), the Italian Dementia Research Association (SINDem) was born. The first congress of this new scientific society took place in Rome in 2006. SINDem soon recognized the importance to investigate sleep problems in cognitive decline and created a national "sleep study group "composed by neurologists and sleep specialists. In 2012, The SINDem study group, in close relationship with the Italian Association of sleep medicine (AIMS), published the study "Prevalence of sleep disturbances in mild cognitive impairment and dementing disorders: a multicenter Italian clinical cross-sectional study on 431 patients ", confirming the high prevalence of sleep disturbances in a wide Italian population of persons with cognitive decline. The study was supported by a grant from the Italian Minister of Health and was conducted with the fundamental contribution of the Italian National Research Center (CNR). In 2014, the same group published the paper "Recommendations of the Sleep Study Group of the Italian Dementia Research Association (SINDem) on clinical assessment and management of sleep disorders in individuals with mild cognitive impairment and dementia: a clinical review". The recommendations are wide and directed to professionals (neurologists but not exclusively) to try to establish uniform levels of care, promote collaborative studies into areas of uncertainty, and define the qualitative characteristics of Dementia Reference Centers about sleep disturbances.

About the Chemopreventive Agent Development Research Group | Division of Cancer Prevention

Cancer.gov

The Chemopreventive Agent Development Research Group promotes and supports research on early chemopreventive agent development, from preclinical studies to phase I clinical trials. The group’s projects aim to identify and develop prevention agents with the potential to block, reverse, or delay the early stages of cancer. The overarching goal is to determine positive and

How novice, skilled and advanced clinical researchers include variables in a case report form for clinical research: a qualitative study

PubMed Central

Chu, Hongling; Zeng, Lin; Fetters, Micheal D; Li, Nan; Tao, Liyuan; Shi, Yanyan; Zhang, Hua; Wang, Xiaoxiao; Li, Fengwei; Zhao, Yiming

2017-01-01

Objectives Despite varying degrees in research training, most academic clinicians are expected to conduct clinical research. The objective of this research was to understand how clinical researchers of different skill levels include variables in a case report form for their clinical research. Setting The setting for this research was a major academic institution in Beijing, China. Participants The target population was clinical researchers with three levels of experience, namely, limited clinical research experience, clinicians with rich clinical research experience and clinical research experts. Methods Using a qualitative approach, we conducted 13 individual interviews (face to face) and one group interview (n=4) with clinical researchers from June to September 2016. Based on maximum variation sampling to identify researchers with three levels of research experience: eight clinicians with limited clinical research experience, five clinicians with rich clinical research experience and four clinical research experts. These 17 researchers had diverse hospital-based medical specialties and or specialisation in clinical research. Results Our analysis yields a typology of three processes developing a case report form that varies according to research experience level. Novice clinician researchers often have an incomplete protocol or none at all, and conduct data collection and publication based on a general framework. Experienced clinician researchers include variables in the case report form based on previous experience with attention to including domains or items at risk for omission and by eliminating unnecessary variables. Expert researchers consider comprehensively in advance data collection and implementation needs and plan accordingly. Conclusion These results illustrate increasing levels of sophistication in research planning that increase sophistication in selection for variables in the case report form. These findings suggest that novice and intermediate-level researchers could benefit by emulating the comprehensive planning procedures such as those used by expert clinical researchers. PMID:28928184

How novice, skilled and advanced clinical researchers include variables in a case report form for clinical research: a qualitative study.

PubMed

Chu, Hongling; Zeng, Lin; Fetters, Micheal D; Li, Nan; Tao, Liyuan; Shi, Yanyan; Zhang, Hua; Wang, Xiaoxiao; Li, Fengwei; Zhao, Yiming

2017-09-18

Despite varying degrees in research training, most academic clinicians are expected to conduct clinical research. The objective of this research was to understand how clinical researchers of different skill levels include variables in a case report form for their clinical research. The setting for this research was a major academic institution in Beijing, China. The target population was clinical researchers with three levels of experience, namely, limited clinical research experience, clinicians with rich clinical research experience and clinical research experts. Using a qualitative approach, we conducted 13 individual interviews (face to face) and one group interview (n=4) with clinical researchers from June to September 2016. Based on maximum variation sampling to identify researchers with three levels of research experience: eight clinicians with limited clinical research experience, five clinicians with rich clinical research experience and four clinical research experts. These 17 researchers had diverse hospital-based medical specialties and or specialisation in clinical research. Our analysis yields a typology of three processes developing a case report form that varies according to research experience level. Novice clinician researchers often have an incomplete protocol or none at all, and conduct data collection and publication based on a general framework. Experienced clinician researchers include variables in the case report form based on previous experience with attention to including domains or items at risk for omission and by eliminating unnecessary variables. Expert researchers consider comprehensively in advance data collection and implementation needs and plan accordingly. These results illustrate increasing levels of sophistication in research planning that increase sophistication in selection for variables in the case report form. These findings suggest that novice and intermediate-level researchers could benefit by emulating the comprehensive planning procedures such as those used by expert clinical researchers. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Clinical Risk Assessment in Intensive Care Unit

PubMed Central

Asefzadeh, Saeed; Yarmohammadian, Mohammad H.; Nikpey, Ahmad; Atighechian, Golrokh

2013-01-01

Background: Clinical risk management focuses on improving the quality and safety of health care services by identifying the circumstances and opportunities that put patients at risk of harm and acting to prevent or control those risks. The goal of this study is to identify and assess the failure modes in the ICU of Qazvin's Social Security Hospital (Razi Hospital) through Failure Mode and Effect Analysis (FMEA). Methods: This was a qualitative-quantitative research by Focus Discussion Group (FDG) performed in Qazvin Province, Iran during 2011. The study population included all individuals and owners who are familiar with the process in ICU. Sampling method was purposeful and the FDG group members were selected by the researcher. The research instrument was standard worksheet that has been used by several researchers. Data was analyzed by FMEA technique. Results: Forty eight clinical errors and failure modes identified, results showed that the highest risk probability number (RPN) was in respiratory care “Ventilator's alarm malfunction (no alarm)” with the score 288, and the lowest was in gastrointestinal “not washing the NG-Tube” with the score 8. Conclusions: Many of the identified errors can be prevented by group members. Clinical risk assessment and management is the key to delivery of effective health care. PMID:23930171

A blended-learning programme regarding professional ethics in physiotherapy students.

PubMed

Aguilar-Rodríguez, Marta; Marques-Sule, Elena; Serra-Añó, Pilar; Espí-López, Gemma Victoria; Dueñas-Moscardó, Lirios; Pérez-Alenda, Sofía

2018-01-01

In the university context, assessing students' attitude, knowledge and opinions when applying an innovative methodological approach to teach professional ethics becomes fundamental to know if the used approach is enough motivating for students. To assess the effect of a blended-learning model, based on professional ethics and related to clinical practices, on physiotherapy students' attitude, knowledge and opinions towards learning professional ethics. Research design and participants: A simple-blind clinical trial was performed (NLM identifier NCT03241693) (control group, n = 64; experimental group, n = 65). Both groups followed clinical practices for 8 months. Control group performed a public exposition of a clinical case about professional ethics. By contrast, an 8-month blended-learning programme regarding professional ethics was worked out for experimental group. An online syllabus and online activities were elaborated, while face-to-face active participation techniques were performed to discuss ethical issues. Students' attitudes, knowledge and opinions towards learning professional ethics were assessed. Ethical considerations: The study was approved by the University Ethic Committee of Human Research and followed the ethical principles according to the Declaration of Helsinki. After the programme, attitudes and knowledge towards learning professional ethics of experimental group students significantly improved, while no differences were observed in control group. Moreover, opinions reported an adequate extension of themes and temporization, importance of clinical practices and interest of topics. Case study method and role playing were considered as the most helpful techniques. The blended-learning programme proposed, based on professional ethics and related to clinical practices, improves physiotherapy students' attitudes, knowledge and opinions towards learning professional ethics.

A Comparison of Nurses’ Activities Under Two Models of Administration

DTIC Science & Technology

1985-08-01

Angela Sheehan, "Innovation in Cancer Nursing and the Role of the Nurse in Clinical Trials," Progress in Clinical and Biological Research 121 (1983): 87...by Diagnosis-Related Groups,* Annals of Internal Medicine 100 (April 1984): 576. 12Tony DeCrosta, " Megatrends in Nursing: 10 New Directions that are...in Clinical Trials." Progress in Clinical and Biological Research 121 (1983): 87-92. Beyers, Marjorie: Byre, Calvin: Levy, Paul: Mallin, Katherine

GOLD Stage and Treatment in COPD: A 500 Patient Point Prevalence Study.

PubMed

Safka, Katherine A; Wald, Joshua; Wang, Hongyu; McIvor, Luke; McIvor, Andrew

2016-12-22

Background and Objective: The Global initiative for chronic Obstructive Lung Disease (GOLD) guidelines recommend using a combination of spirometry, symptoms and exacerbation history to classify patients into 4 categories (A, B, C, D) to guide treatment decisions along with a stepwise increase in therapy. Our objectives were to identify the GOLD stage of patients in respiratory outpatient clinics and assess how treatment compares to guideline recommendations. Methods: This was a point prevalence study using a convenience sample of 500 patients with chronic obstructive pulmonary disease (COPD) from a single tertiary care outpatient respiratory clinic. Results: Patients' GOLD classification was determined based on symptoms (modified Medical Research Council [mMRC] dyspnea scale, COPD Assessment Test [CAT]), spirometry and self-reported exacerbation history. A total of 8.2% of patients were in the GOLD group A, 28.3% in group B, 4.2% in group C and 59.2% in group D. Conclusions: In this 500 patient point prevalence study we report a low proportion of patients in GOLD group C and a high level of inhaled corticosteroids (ICS)/ long-acting beta2-agonist (LABA) and triple therapy use throughout all GOLD categories. Clinical Implications: The GOLD guidelines have attempted to provide direction to practitioners by grouping patients into 4 groups based on symptoms and exacerbations however, the low prevalence of GOLD group C may indicate that not all of these groupings are clinically relevant. Future research is needed to better identify clinically relevant phenotypes that predict benefit from ICS and methods to promote guideline concordant management in COPD.

Translating evidence to practice in the health professions: a randomized trial of Twitter vs Facebook.

PubMed

Tunnecliff, Jacqueline; Weiner, John; Gaida, James E; Keating, Jennifer L; Morgan, Prue; Ilic, Dragan; Clearihan, Lyn; Davies, David; Sadasivan, Sivalal; Mohanty, Patitapaban; Ganesh, Shankar; Reynolds, John; Maloney, Stephen

2017-03-01

Our objective was to compare the change in research informed knowledge of health professionals and their intended practice following exposure to research information delivered by either Twitter or Facebook. This open label comparative design study randomized health professional clinicians to receive "practice points" on tendinopathy management via Twitter or Facebook. Evaluated outcomes included knowledge change and self-reported changes to clinical practice. Four hundred and ninety-four participants were randomized to 1 of 2 groups and 317 responders analyzed. Both groups demonstrated improvements in knowledge and reported changes to clinical practice. There was no statistical difference between groups for the outcomes of knowledge change (P = .728), changes to clinical practice (P = .11) or the increased use of research information (P = .89). Practice points were shared more by the Twitter group (P < .001); attrition was lower in the Facebook group (P < .001). Research information delivered by either Twitter or Facebook can improve clinician knowledge and promote behavior change. No differences in these outcomes were observed between the Twitter and Facebook groups. Brief social media posts are as effective as longer posts for improving knowledge and promoting behavior change. Twitter may be more useful in publicizing information and Facebook for encouraging course completion. © The Author 2016. Published by Oxford University Press on behalf of the American Medical Informatics Association. All rights reserved. For Permissions, please email: journals.permissions@oup.com

Effect of case-based learning on the development of graduate nurses' problem-solving ability.

PubMed

Yoo, Moon-Sook; Park, Jin-Hee

2014-01-01

Case-based learning (CBL) is a teaching strategy which promotes clinical problem-solving ability. This research was performed to investigate the effects of CBL on problem-solving ability of graduate nurses. This research was a quasi-experimental design using pre-test, intervention, and post-test with a non-synchronized, non-equivalent control group. The study population was composed of 190 new graduate nurses from university hospital A in Korea. Results of the research indicate that there was a statistically significant difference in objective problem-solving ability scores of CBL group demonstrating higher scores. Subjective problem-solving ability was also significantly higher in CBL group than in the lecture-based group. These results may suggest that CBL is a beneficial and effective instructional method of training graduate nurses to improve their clinical problem-solving ability. Copyright © 2013 Elsevier Ltd. All rights reserved.

Depression Anxiety and Stress Scales (DASS-21): psychometric analysis across four racial groups.

PubMed

Norton, Peter J

2007-09-01

Growing cross-cultural awareness has led researchers to examine frequently used research instruments and assessment tools in racially diverse populations. The present study was conducted to assess the psychometric characteristics of the 21-item version of the Depression, Anxiety, and Stress Scales (DASS-21) among different racial groups. The DASS-21 was chosen because it appears to be a reliable and easy to administer measure, ideal for both clinical and research purposes. Results suggest that the internal consistency, and convergent and divergent validity of the DASS-21 are similar across racial groups. Multigroup CFA, however, indicated that item loadings were invariant, while scale covariances were not invariant. This suggests that, although the items may load similarly on the depression, anxiety and stress constructs, these constructs may be differentially inter-related across groups. Implications for application in clinical practice are discussed.

The ethics and regulatory landscape of including vulnerable populations in pragmatic clinical trials.

PubMed

Welch, Mary Jane; Lally, Rachel; Miller, Jennifer E; Pittman, Stephanie; Brodsky, Lynda; Caplan, Arthur L; Uhlenbrauck, Gina; Louzao, Darcy M; Fischer, James H; Wilfond, Benjamin

2015-10-01

Policies have been developed to protect vulnerable populations in clinical research, including the US federal research regulations (45 Code of Federal Regulations 46 Subparts B, C, and D). These policies generally recognize vulnerable populations to include pregnant women, fetuses, neonates, children, prisoners, persons with physical handicaps or mental disabilities, and disadvantaged persons. The aim has been to protect these populations from harm, often by creating regulatory and ethical checks that may limit their participation in many clinical trials. The recent increase in pragmatic clinical trials raises at least two questions about this approach. First, is exclusion itself a harm to vulnerable populations, as these groups may be denied access to understanding how health interventions work for them in clinical settings? Second, are groups considered vulnerable in traditional clinical trials also vulnerable in pragmatic clinical trials? We argue first that excluding vulnerable subjects from participation in pragmatic clinical trials can be harmful by preventing acquisition of data to meaningfully inform clinical decision-making in the future. Second, we argue that protections for vulnerable subjects in traditional clinical trial settings may not be translatable, feasible, or even ethical to apply in pragmatic clinical trials. We conclude by offering specific recommendations for appropriately protecting vulnerable research subjects in pragmatic clinical trials, focusing on pregnant women, fetuses, neonates, children, prisoners, persons with physical handicaps or mental disabilities, and disadvantaged persons. © The Author(s) 2015.

The effect of group psycho-education program on the burden of family caregivers with multiple sclerosis patients in Isfahan in 2013-2014.

PubMed

Pahlavanzadeh, Saeid; Dalvi-Isfahani, Fariba; Alimohammadi, Nasrollah; Chitsaz, Ahmad

2015-01-01

Lack of adequate training and support of primary caregivers of multiple sclerosis (MS) patients is the major factor in causing stress, anxiety, and increase of burden. Therefore, the treatment team members such as psychiatric nurses can help these vulnerable people overcome psychiatric pressures effectively not only through their care and referral role but also through their supportive characteristic, which helps the patients improve their clinical status, together with their social, familial, and work adaptation. Therefore, the researcher tried to identify the effect of a group psycho-education program on the burden family caregivers with MS patients. This is a two-group three-stage clinical trial. The researcher referred to the heads of neurology clinics to present the purpose of the study and to start the sampling. The neurology clinics of AL Zahra University Hospital, and also a Private Neurology Clinic were selected to collect the data of the study. The subjects were randomly selected, and then, assigned to two groups of study and control. Independent t-test showed a significant reduction in family caregivers' burden immediately after and 1-month after intervention in the study group, compared to control. Repeated measure ANOVA showed a significant reduction in caregivers' burden mean score in the study group (P < 0.001). As group psycho-education reduced family caregivers' burden, it is recommended to develop and design other programs for the family caregivers of the patients with MS.

Development and implementation of clinical trial protocol templates at the National Institute of Allergy and Infectious Diseases.

PubMed

Bridge, Heather; Smolskis, Mary; Bianchine, Peter; Dixon, Dennis O; Kelly, Grace; Herpin, Betsey; Tavel, Jorge

2009-08-01

A clinical research protocol document must reflect both sound scientific rationale as well as local, national and, when applicable, international regulatory and human subject protections requirements. These requirements originate from a variety of sources, undergo frequent revision and are subject to interpretation. Tools to assist clinical investigators in the production of clinical protocols could facilitate navigating these requirements and ultimately increase the efficiency of clinical research. The National Institute of Allergy and Infectious Diseases (NIAID) developed templates for investigators to serve as the foundation for protocol development. These protocol templates are designed as tools to support investigators in developing clinical protocols. NIAID established a series of working groups to determine how to improve its capacity to conduct clinical research more efficiently and effectively. The Protocol Template Working Group was convened to determine what protocol templates currently existed within NIAID and whether standard NIAID protocol templates should be produced. After review and assessment of existing protocol documents and requirements, the group reached consensus about required and optional content, determined the format and identified methods for distribution as well as education of investigators in the use of these templates. The templates were approved by the NIAID Executive Committee in 2006 and posted as part of the NIAID Clinical Research Toolkit [1] website for broad access. These documents require scheduled revisions to stay current with regulatory and policy changes. The structure of any clinical protocol template, whether comprehensive or specific to a particular study phase, setting or design, affects how it is used by investigators. Each structure presents its own set of advantages and disadvantages. While useful, protocol templates are not stand-alone tools for creating an optimal protocol document, but must be complemented by institutional resources and support. Education and guidance of investigators in the appropriate use of templates is necessary to ensure a complete yet concise protocol document. Due to changing regulatory requirements, clinical protocol templates cannot become static, but require frequent revisions.

Teaching medical students to discern ethical problems in human clinical research studies.

PubMed

Roberts, Laura Weiss; Warner, Teddy D; Green Hammond, Katherine A; Brody, Janet L; Kaminsky, Alexis; Roberts, Brian B

2005-10-01

Investigators and institutional review boards are entrusted with ensuring the conduct of ethically sound human studies. Assessing ethical aspects of research protocols is a key skill in fulfilling this duty, yet no empirically validated method exists for preparing professionals to attain this skill. The authors performed a randomized controlled educational intervention, comparing a criteria-based learning method, a clinical-research- and experience-based learning method, and a control group. All 300 medical students enrolled at the University of New Mexico School of Medicine in 2001 were invited to participate. After a single half-hour educational session, a written posttest of ability to detect ethical problems in hypothetical protocol vignettes was administered. The authors analyzed responses to ten protocol vignettes that had been evaluated independently by experts. For each vignette, a global assessment of the perceived significance of ethical problems and the identification of specific ethical problems were evaluated. Eighty-three medical students (27%) volunteered: 50 (60%) were women and 55 (66%) were first- and second-year students. On global assessments, the criteria-focused group perceived ethical problems as more significant than did the other two groups (p < .02). Students in the criteria-focused group were better able than students in the control group (p < .03) to discern specific ethical problems, more closely resembling expert assessments. Unexpectedly, the group focused on clinical research participants identified fewer problems than did the control group (p < .05). The criteria-focused intervention produced enhanced ethical evaluation skills. This work supports the potential value of empirically derived methods for preparing professionals to discern ethical aspects of human studies.

Application of adult attachment theory to group member transference and the group therapy process.

PubMed

Markin, Rayna D; Marmarosh, Cheri

2010-03-01

Although clinical researchers have applied attachment theory to client conceptualization and treatment in individual therapy, few researchers have applied this theory to group therapy. The purpose of this article is to begin to apply theory and research on adult dyadic and group attachment styles to our understanding of group dynamics and processes in adult therapy groups. In particular, we set forth theoretical propositions on how group members' attachment styles affect relationships within the group. Specifically, this article offers some predictions on how identifying group member dyadic and group attachment styles could help leaders predict member transference within the therapy group. Implications of group member attachment for the selection and composition of a group and the different group stages are discussed. Recommendations for group clinicians and researchers are offered. PsycINFO Database Record (c) 2010 APA, all rights reserved

Strategies to Support Recruitment of Patients with Life-limiting illness for Research: The Palliative Care Research Cooperative Group

PubMed Central

Hanson, Laura C.; Bull, Janet; Wessell, Kathryn; Massie, Lisa; Bennett, Rachael E.; Kutner, Jean S.; Aziz, Noreen M.; Abernethy, Amy

2014-01-01

Context The Palliative Care Research Cooperative group (PCRC) is the first clinical trials cooperative for palliative care in the United States. Objectives To describe barriers and strategies for recruitment during the inaugural PCRC clinical trial. Methods The parent study was a multi-site randomized controlled trial enrolling adults with life expectancy anticipated to be 1–6 months, randomized to discontinue statins (intervention) vs. to continue on statins (control). To study recruitment best practices, we conducted semi-structured interviews with 18 site Principal Investigators (PI) and Clinical Research Coordinators (CRC), and reviewed recruitment rates. Interviews covered 3 topics – 1) successful strategies for recruitment, 2) barriers to recruitment, and 3) optimal roles of the PI and CRC. Results All eligible site PIs and CRCs completed interviews and provided data on statin protocol recruitment. The parent study completed recruitment of n=381 patients. Site enrollment ranged from 1–109 participants, with an average of 25 enrolled per site. Five major barriers included difficulty locating eligible patients, severity of illness, family and provider protectiveness, seeking patients in multiple settings, and lack of resources for recruitment activities. Five effective recruitment strategies included systematic screening of patient lists, thoughtful messaging to make research relevant, flexible protocols to accommodate patients’ needs, support from clinical champions, and the additional resources of a trials cooperative group. Conclusion The recruitment experience from the multi-site PCRC yields new insights into methods for effective recruitment to palliative care clinical trials. These results will inform training materials for the PCRC and may assist other investigators in the field. PMID:24863152

Postdoctoral Fellow | Center for Cancer Research

Cancer.gov

The Laboratory of Tumor Immunology and Biology (LTIB) functions as a multidisciplinary and interdisciplinary translational research programmatic effort with the goal of developing novel immunotherapies for cancer. The LTIB strategic plan focuses on the development of novel immunotherapeutics for human cancer, not only as monotherapies, but more importantly, in combination with other immune-mediating modalities, and other conventional or experimental therapies, as part of an immuno-oncology programmatic effort. Within this effort are several research groups, a clinical trials group, and multiple collaborations with intramural and extramural scientific and clinical investigators and with investigators in the private sector. The program takes advantage of the uniqueness of the NCI intramural program in that it spans high-risk basic discovery research in immunology, genomics and tumor biology, through preclinical translational research, to paradigm-shifting clinical trials. Focus is placed on the design and development of novel "off-the-shelf" recombinant immunotherapeutics that can be used in clinical studies at numerous institutions. A major strength of the program is the rapid translation of preclinical studies to hypothesis-generating clinical trials. We are looking for postdoctoral fellows interested in learning immunology and immunotherapy, as well as those postdoctoral fellows with a background and/or interest in experimental pathology.  The position is available immediately. The appointment duration is up to 5 years. Stipends are commensurate with education and experience.

Children's self reported discomforts as participants in clinical research.

PubMed

Staphorst, Mira S; Hunfeld, Joke A M; van de Vathorst, Suzanne; Passchier, Jan; van Goudoever, Johannes B

2015-10-01

There is little empirical evidence on children's subjective experiences of discomfort during clinical research procedures. Therefore, Institutional Review Boards have limited empirical information to guide their decision-making on discomforts for children in clinical research. To get more insight into what children's discomforts are during clinical research procedures, we interviewed a group of children on this topic and also asked for suggestions to reduce possible discomforts. Forty-six children (aged 6-18) participating in clinical research studies (including needle-related procedures, food provocation tests, MRI scans, pulmonary function tests, questionnaires) were interviewed about their experiences during the research procedures. Thematic analysis was used to analyze the interviews. The discomforts of the interviewed children could be divided into two main groups: physical and mental discomforts. The majority experienced physical discomforts during the research procedures: pain, shortness of breath, nausea, itchiness, and feeling hungry, which were often caused by needle procedures, some pulmonary procedures, and food provocation tests. Mental discomforts included anxiousness because of anticipated pain and not knowing what to expect from a research procedure, boredom and tiredness during lengthy research procedures and waiting, and embarrassment during Tanner staging. Children's suggestions to reduce the discomforts of the research procedures were providing distraction (e.g. watching a movie or listening to music), providing age-appropriate information and shortening the duration of lengthy procedures. Our study shows that children can experience various discomforts during research procedures, and it provides information about how these discomforts can be reduced according to them. Further research is needed with larger samples to study the number of children that experience these mentioned discomforts during research procedures in a quantitative way. Copyright © 2015 Elsevier Ltd. All rights reserved.

Describing the implementation of an innovative intervention and evaluating its effectiveness in increasing research capacity of advanced clinical nurses: using the consolidated framework for implementation research.

PubMed

McKee, Gabrielle; Codd, Margaret; Dempsey, Orla; Gallagher, Paul; Comiskey, Catherine

2017-01-01

Despite advanced nursing roles having a research competency, participation in research is low. There are many barriers to participation in research and few interventions have been developed to address these. This paper aims to describe the implementation of an intervention to increase research participation in advanced clinical nursing roles and evaluate its effectiveness. The implementation of the intervention was carried out within one hospital site. The evaluation utilised a mixed methods design and a implementation science framework. All staff in advanced nursing roles were invited to take part, all those who were interested and had a project in mind could volunteer to participate in the intervention. The intervention consisted of the development of small research groups working on projects developed by the nurse participant/s and supported by an academic and a research fellow. The main evaluation was through focus groups. Output was analysed using thematic analysis. In addition, a survey questionnaire was circulated to all participants to ascertain their self-reported research skills before and after the intervention. The results of the survey were analysed using descriptive statistics. Finally an inventory of research outputs was collated. In the first year, twelve new clinical nurse-led research projects were conducted and reported in six peer reviewed papers, two non-peer reviewed papers and 20 conference presentations. The main strengths of the intervention were its promptness to complete research, to publish and to showcase clinical innovations. Main barriers identified were time, appropriate support from academics and from peers. The majority of participants had increased experience at scientific writing and data analysis. This study shows that an intervention, with minor financial resources; a top down approach; support of a hands on research fellow; peer collaboration with academics; strong clinical ownership by the clinical nurse researcher; experiential learning opportunities; focused and with needs based educational sessions, is an intervention that can both increase research outputs and capacity of clinically based nurses. Interventions to further enhance nursing research and their evaluation are crucial if we are to address the deficit of nurse-led patient-centred research in the literature.

How Researchers Define Vulnerable Populations in HIV/AIDS Clinical Trials

PubMed Central

Lo, Bernard; Strauss, Ronald P.; Eron, Joseph; Gifford, Allen L.

2010-01-01

In this study, we interviewed researchers, asking them to define vulnerable populations in HIV/AIDS clinical trials, and provide feedback on the federal regulations for three vulnerable populations. Interview data informed a conceptual framework, and were content analyzed to identify acceptability or disagreement with the regulations. Beginning with several characteristics of vulnerable enrollees identified by researchers, the conceptual framework illustrates possible scenarios of how enrollees could be considered vulnerable in clinical research. Content analysis identified barriers affecting HIV/AIDS researchers’ ability to conduct clinical trials with pregnant women, prisoners, and children, for which the regulations specify additional protections. This study challenges current thinking about federal regulations’ group-based approach to defining vulnerable populations. PMID:20721614

Clinical research in a hospital--from the lone rider to teamwork.

PubMed

Hannisdal, E

1996-01-01

Clinical research of high international standard is very demanding and requires clinical data of high quality, software, hardware and competence in research design and statistical treatment of data. Most busy clinicians have little time allocated for clinical research and this increases the need for a potent infrastructure. This paper describes how the Norwegian Radium Hospital, a specialized cancer hospital, has reorganized the clinical research process. This includes a new department, the Clinical Research Office, which serves the formal framework, a central Diagnosis Registry, clinical databases and multicentre studies. The department assists about 120 users, mainly clinicians. Installation of a network software package with over 10 programs has strongly provided an internal standardization, reduced the costs and saved clinicians a great deal of time. The hospital is building up about 40 diagnosis-specific clinical databases with up to 200 variables registered. These databases are shared by the treatment group and seem to be important tools for quality assurance. We conclude that the clinical research process benefits from a firm infrastructure facilitating teamwork through extensive use of modern information technology. We are now ready for the next phase, which is to work for a better external technical framework for cooperation with other institutions throughout the world.

Thrombosis in Cancer: Research Priorities Identified by a National Cancer Institute/National Heart, Lung, and Blood Institute Strategic Working Group.

PubMed

Key, Nigel S; Khorana, Alok A; Mackman, Nigel; McCarty, Owen J T; White, Gilbert C; Francis, Charles W; McCrae, Keith R; Palumbo, Joseph S; Raskob, Gary E; Chan, Andrew T; Sood, Anil K

2016-07-01

The risk for venous thromboembolism (VTE) is increased in cancer and particularly with chemotherapy, and it portends poorer survival among patients with cancer. However, many fundamental questions about cancer-associated VTE, or Trousseau syndrome, remain unanswered. This report summarizes the proceedings of a working group assembled by the NCI and NHLBI in August 2014 to explore the state of the science in cancer-associated VTE, identify clinically important research gaps, and develop consensus on priorities for future research. Representing a convergence of research priorities between the two NIH Institutes, the workshop addressed epidemiologic, basic science, clinical, and translational issues in cancer-associated VTE. Cancer Res; 76(13); 3671-5. ©2016 AACR. ©2016 American Association for Cancer Research.

Development of a bipolar disorder biobank: differential phenotyping for subsequent biomarker analyses.

PubMed

Frye, Mark A; McElroy, Susan L; Fuentes, Manuel; Sutor, Bruce; Schak, Kathryn M; Galardy, Christine W; Palmer, Brian A; Prieto, Miguel L; Kung, Simon; Sola, Christopher L; Ryu, Euijung; Veldic, Marin; Geske, Jennifer; Cuellar-Barboza, Alfredo; Seymour, Lisa R; Mori, Nicole; Crowe, Scott; Rummans, Teresa A; Biernacka, Joanna M

2015-12-01

We aimed to establish a bipolar disorder biobank to serve as a resource for clinical and biomarker studies of disease risk and treatment response. Here, we describe the aims, design, infrastructure, and research uses of the biobank, along with demographics and clinical features of the first participants enrolled. Patients were recruited for the Mayo Clinic Bipolar Biobank beginning in July 2009. The Structured Clinical Interview for DSM-IV was used to confirm bipolar diagnosis. The Bipolar Biobank Clinical Questionnaire and Participant Questionnaire were designed to collect detailed demographic and clinical data, including clinical course of illness measures that would delineate differential phenotypes for subsequent analyses. Blood specimens were obtained from participants, and various aliquots were stored for future research. As of September 2014, 1363 participants have been enrolled in the bipolar biobank. Among these first participants, 69.0 % had a diagnosis of bipolar disorder type I. The group was 60.2 % women and predominantly white (90.6 %), with a mean (SD) age of 42.6 (14.9) years. Clinical phenotypes of the group included history of psychosis (42.3 %), suicide attempt (32.5 %), addiction to alcohol (39.1 %), addiction to nicotine (39.8 %), obesity (42.9 %), antidepressant-induced mania (31.7 %), tardive dyskinesia (3.2 %), and history of drug-related serious rash (5.7 %). Quantifying phenotypic patterns of illness beyond bipolar subtype can provide more detailed clinical disease characteristics for biomarker research, including genomic-risk studies. Future research can harness clinically useful biomarkers using state-of-the-art research technology to help stage disease burden and better individualize treatment selection for patients with bipolar disorder.

78 FR 22274 - National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2013-04-15

... Infectious Diseases Special Emphasis Panel; ``Leadership Group for a Clinical Research Network on... Transplantation Research; 93.856, Microbiology and Infectious Diseases Research, National Institutes of Health...

Chest electrical impedance tomography examination, data analysis, terminology, clinical use and recommendations: consensus statement of the TRanslational EIT developmeNt stuDy group.

PubMed

Frerichs, Inéz; Amato, Marcelo B P; van Kaam, Anton H; Tingay, David G; Zhao, Zhanqi; Grychtol, Bartłomiej; Bodenstein, Marc; Gagnon, Hervé; Böhm, Stephan H; Teschner, Eckhard; Stenqvist, Ola; Mauri, Tommaso; Torsani, Vinicius; Camporota, Luigi; Schibler, Andreas; Wolf, Gerhard K; Gommers, Diederik; Leonhardt, Steffen; Adler, Andy

2017-01-01

Electrical impedance tomography (EIT) has undergone 30 years of development. Functional chest examinations with this technology are considered clinically relevant, especially for monitoring regional lung ventilation in mechanically ventilated patients and for regional pulmonary function testing in patients with chronic lung diseases. As EIT becomes an established medical technology, it requires consensus examination, nomenclature, data analysis and interpretation schemes. Such consensus is needed to compare, understand and reproduce study findings from and among different research groups, to enable large clinical trials and, ultimately, routine clinical use. Recommendations of how EIT findings can be applied to generate diagnoses and impact clinical decision-making and therapy planning are required. This consensus paper was prepared by an international working group, collaborating on the clinical promotion of EIT called TRanslational EIT developmeNt stuDy group. It addresses the stated needs by providing (1) a new classification of core processes involved in chest EIT examinations and data analysis, (2) focus on clinical applications with structured reviews and outlooks (separately for adult and neonatal/paediatric patients), (3) a structured framework to categorise and understand the relationships among analysis approaches and their clinical roles, (4) consensus, unified terminology with clinical user-friendly definitions and explanations, (5) a review of all major work in thoracic EIT and (6) recommendations for future development (193 pages of online supplements systematically linked with the chief sections of the main document). We expect this information to be useful for clinicians and researchers working with EIT, as well as for industry producers of this technology. 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/.

Differences between patients' and clinicians' research priorities from the Anaesthesia and Peri-operative Care Priority Setting Partnership.

PubMed

Boney, O; Nathanson, M H; Grocott, M P W; Metcalf, L

2017-09-01

The James Lind Alliance Anaesthesia and Peri-operative Care Priority Setting Partnership was a recent collaborative venture bringing approximately 2000 patients, carers and clinicians together to agree priorities for future research into anaesthesia and critical care. This secondary analysis compares the research priorities of 303 service users, 1068 clinicians and 325 clinicians with experience as service users. All three groups prioritised research to improve patient safety. Service users prioritised research about improving patient experience, whereas clinicians prioritised research about clinical effectiveness. Clinicians who had experience as service users consistently prioritised research more like clinicians than like service users. Individual research questions about patient experience were more popular with patients and carers than with clinicians in all but one case. We conclude that patients, carers and clinicians prioritise research questions differently. All groups prioritise research into patient safety, but service users also favour research into patient experience, whereas clinicians favour research into clinical effectiveness. © 2017 The Association of Anaesthetists of Great Britain and Ireland.

Refining Video Game Use Questionnaires for Research and Clinical Application: Detection of Problematic Response Sets

ERIC Educational Resources Information Center

Faust, Kyle A.; Faust, David; Baker, Aaron M.; Meyer, Joseph F.

2012-01-01

Even when relatively infrequent, deviant response sets, such as defensive and careless responding, can have remarkably robust effects on individual and group data and thereby distort clinical evaluations and research outcomes. Given such potential adverse impacts and the widespread use of self-report measures when appraising addictions and…

Summary and Agreement Statement of the First International Conference on Concussion in Sport, Vienna 2001.

ERIC Educational Resources Information Center

Aubry, Mark; Cantu, Robert; Dvorak, Jiri; Graf-Baumann, Toni; Johnston, Karen; Kelly, James; Lovell, Mark; McCrory, Paul; Meeuwisse, Willem; Schamasch, Patrick

2002-01-01

An international group of concussion experts met in 2001 to discuss the most recent research and findings and to establish guidelines for clinical practice. They addressed such issues as epidemiology, basic and clinical science, grading systems, cognitive assessment, new research methods, protective equipment, management, prevention, and long-term…

Friday's Agenda | Division of Cancer Prevention

Cancer.gov

TimeAgenda8:00 am - 8:10 amWelcome and Opening RemarksLeslie Ford, MDAssociate Director for Clinical ResearchDivision of Cancer Prevention, NCIEva Szabo, MD Chief, Lung and Upper Aerodigestive Cancer Research GroupDivision of Cancer Prevention, NCI8:10 am - 8:40 amClinical Trials Statistical Concepts for Non-StatisticiansKevin Dodd, PhD |

Incorporating ethical principles into clinical research protocols: a tool for protocol writers and ethics committees.

PubMed

Li, Rebecca H; Wacholtz, Mary C; Barnes, Mark; Boggs, Liam; Callery-D'Amico, Susan; Davis, Amy; Digilova, Alla; Forster, David; Heffernan, Kate; Luthin, Maeve; Lynch, Holly Fernandez; McNair, Lindsay; Miller, Jennifer E; Murphy, Jacquelyn; Van Campen, Luann; Wilenzick, Mark; Wolf, Delia; Woolston, Cris; Aldinger, Carmen; Bierer, Barbara E

2016-04-01

A novel Protocol Ethics Tool Kit ('Ethics Tool Kit') has been developed by a multi-stakeholder group of the Multi-Regional Clinical Trials Center of Brigham and Women's Hospital and Harvard. The purpose of the Ethics Tool Kit is to facilitate effective recognition, consideration and deliberation of critical ethical issues in clinical trial protocols. The Ethics Tool Kit may be used by investigators and sponsors to develop a dedicated Ethics Section within a protocol to improve the consistency and transparency between clinical trial protocols and research ethics committee reviews. It may also streamline ethics review and may facilitate and expedite the review process by anticipating the concerns of ethics committee reviewers. Specific attention was given to issues arising in multinational settings. With the use of this Tool Kit, researchers have the opportunity to address critical research ethics issues proactively, potentially speeding the time and easing the process to final protocol approval. 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/

Translating research findings of chronic kidney disease management to clinical practice: Challenges and opportunities.

PubMed

Stevens, Lesley Ann; Levin, Adeera

2004-01-01

Chronic Kidney disease (CKD) has been identified as a public health epidemic, fueled in part by improved outcomes of both diabetic and cardiac patient populations, as well as by the increasing recognition that it is possible to identify CKD at earlier stages. The estimated 8 to 10 million Americans that have CKD, with its concomitant morbidity and mortality, have the potential to overwhelm the current system of specialty practice medicine and health care resources. How can clinicians, clinician scientists, and health care administrators translate research findings into clinical practice in an effective manner to improve the care of this burgeoning patient group? The challenge of translating research into clinical care requires identification of that which we do and do not know, communication of knowledge between those who do and do not know, and efficient collection of information for systematic evaluation. This article will describe the challenges of translating current research findings into clinical practice. There is a need to identify the complexity of CKD disease processes and issues associated with delivery of care and to describe the difficulties in the dissemination of new knowledge to physicians. Because of the propensity of CKD to affect identifiable groups of patients, we will discuss the potential challenges of these strategies given the racial, ethnic, and cultural diversity in North America. A potential solution to these challenges is a new paradigm of "process-based medicine" that integrates clinical and basic science research findings with multidisciplinary and shared care models of health care delivery. In this context, attention to advances in information technology, the cognitive processes that underlie physician learning, and the findings of outcome research may ensure true integration of clinical research and clinical practice.

Giving Voice to Study Volunteers: Comparing views of mentally ill, physically ill, and healthy protocol participants on ethical aspects of clinical research

PubMed Central

Roberts, Laura Weiss; Kim, Jane Paik

2014-01-01

Motivation Ethical controversy surrounds clinical research involving seriously ill participants. While many stakeholders have opinions, the extent to which protocol volunteers themselves see human research as ethically acceptable has not been documented. To address this gap of knowledge, authors sought to assess views of healthy and ill clinical research volunteers regarding the ethical acceptability of human studies involving individuals who are ill or are potentially vulnerable. Methods Surveys and semi-structured interviews were used to query clinical research protocol participants and a comparison group of healthy individuals. A total of 179 respondents participated in this study: 150 in protocols (60 mentally ill, 43 physically ill, and 47 healthy clinical research protocol participants) and 29 healthy individuals not enrolled in protocols. Main outcome measures included responses regarding ethical acceptability of clinical research when it presents significant burdens and risks, involves people with serious mental and physical illness, or enrolls people with other potential vulnerabilities in the research situation. Results Respondents expressed decreasing levels of acceptance of participation in research that posed burdens of increasing severity. Participation in protocols with possibly life-threatening consequences was perceived as least acceptable (mean = 1.82, sd = 1.29). Research on serious illnesses, including HIV, cancer, schizophrenia, depression, and post-traumatic stress disorder, was seen as ethically acceptable across respondent groups (range of means = [4.0, 4.7]). Mentally ill volunteers expressed levels of ethical acceptability for physical illness research and mental illness research as acceptable and similar, while physically ill volunteers expressed greater ethical acceptability for physical illness research than for mental illness research. Mentally ill, physically ill, and healthy participants expressed neutral to favorable perspectives regarding the ethical acceptability of clinical research participation by potentially vulnerable subpopulations (difference in acceptability perceived by mentally ill - healthy=−0.04, CI [−0.46, 0.39]; physically ill – healthy= −0.13, CI [−0.62, −.36]). Conclusions Clinical research volunteers and healthy clinical research-“naive” individuals view studies involving ill people as ethically acceptable, and their responses reflect concern regarding research that poses considerable burdens and risks and research involving vulnerable subpopulations. Physically ill research volunteers may be more willing to see burdensome and risky research as acceptable. Mentally ill research volunteers and healthy individuals expressed similar perspectives in this study, helping to dispel a misconception that those with mental illness should be presumed to hold disparate views. PMID:24931849

Giving voice to study volunteers: comparing views of mentally ill, physically ill, and healthy protocol participants on ethical aspects of clinical research.

PubMed

Roberts, Laura Weiss; Kim, Jane Paik

2014-09-01

Ethical controversy surrounds clinical research involving seriously ill participants. While many stakeholders have opinions, the extent to which protocol volunteers themselves see human research as ethically acceptable has not been documented. To address this gap of knowledge, authors sought to assess views of healthy and ill clinical research volunteers regarding the ethical acceptability of human studies involving individuals who are ill or are potentially vulnerable. Surveys and semi-structured interviews were used to query clinical research protocol participants and a comparison group of healthy individuals. A total of 179 respondents participated in this study: 150 in protocols (60 mentally ill, 43 physically ill, and 47 healthy clinical research protocol participants) and 29 healthy individuals not enrolled in protocols. Main outcome measures included responses regarding ethical acceptability of clinical research when it presents significant burdens and risks, involves people with serious mental and physical illness, or enrolls people with other potential vulnerabilities in the research situation. Respondents expressed decreasing levels of acceptance of participation in research that posed burdens of increasing severity. Participation in protocols with possibly life-threatening consequences was perceived as least acceptable (mean = 1.82, sd = 1.29). Research on serious illnesses, including HIV, cancer, schizophrenia, depression, and post-traumatic stress disorder, was seen as ethically acceptable across respondent groups (range of means = [4.0, 4.7]). Mentally ill volunteers expressed levels of ethical acceptability for physical illness research and mental illness research as acceptable and similar, while physically ill volunteers expressed greater ethical acceptability for physical illness research than for mental illness research. Mentally ill, physically ill, and healthy participants expressed neutral to favorable perspectives regarding the ethical acceptability of clinical research participation by potentially vulnerable subpopulations (difference in acceptability perceived by mentally ill - healthy = -0.04, CI [-0.46, 0.39]; physically ill - healthy = -0.13, CI [-0.62, -.36]). Clinical research volunteers and healthy clinical research-"naïve" individuals view studies involving ill people as ethically acceptable, and their responses reflect concern regarding research that poses considerable burdens and risks and research involving vulnerable subpopulations. Physically ill research volunteers may be more willing to see burdensome and risky research as acceptable. Mentally ill research volunteers and healthy individuals expressed similar perspectives in this study, helping to dispel a misconception that those with mental illness should be presumed to hold disparate views. Copyright © 2014 Elsevier Ltd. All rights reserved.

Caught between a rock and a hard place: An intrinsic single case study of nurse researchers' experiences of the presence of a nursing research culture in clinical practice.

PubMed

Berthelsen, Connie Bøttcher; Hølge-Hazelton, Bibi

2018-04-01

To explore how nurse researchers in clinical positions experience the presence of a nursing research culture in clinical practice. Higher demands in the hospitals for increasing the quality of patient care engender a higher demand for the skills of health professionals and evidence-based practice. However, the utilisation of nursing research in clinical practice is still limited. Intrinsic single case study design underlined by a constructivist perspective. Data were produced through a focus group interview with seven nurse researchers employed in clinical practice in two university hospitals in Zealand, Denmark, to capture the intrinsic aspects of the concept of nursing research culture in the context of clinical practice. A thematic analysis was conducted based on Braun and Clarke's theoretical guideline. "Caught between a rock and a hard place" was constructed as the main theme describing how nurse researchers in clinical positions experience the presence of a nursing research culture in clinical practice. The main theme was supported by three subthemes: Minimal academic tradition affects nursing research; Minimal recognition from physicians affects nursing research; and Moving towards a research culture. The nurse researchers in this study did not experience the presence of a nursing research culture in clinical practice, however; they called for more attention on removing barriers against research utilisation, promotion of applied research and interdisciplinary research collaboration, and passionate management support. The results of this case study show the pressure which nurse researchers employed in clinical practice are exposed to, and give examples on how to accommodate the further development of a nursing research culture in clinical practice. © 2017 John Wiley & Sons Ltd.

The physical therapy clinical research network (PTClinResNet): methods, efficacy, and benefits of a rehabilitation research network.

PubMed

Winstein, Carolee; Pate, Patricia; Ge, Tingting; Ervin, Carolyn; Baurley, James; Sullivan, Katherine J; Underwood, Samantha J; Fowler, Eileen G; Mulroy, Sara; Brown, David A; Kulig, Kornelia; Gordon, James; Azen, Stanley P

2008-11-01

This article describes the vision, methods, and implementation strategies used in building the infrastructure for PTClinResNet, a clinical research network designed to assess outcomes for health-related mobility associated with evidence-based physical therapy interventions across and within four different disability groups. Specific aims were to (1) create the infrastructure necessary to develop and sustain clinical trials research in rehabilitation, (2) generate evidence to evaluate the efficacy of resistance exercise-based physical interventions designed to improve muscle performance and movement skills, and (3) provide education and training opportunities for present and future clinician-researchers and for the rehabilitation community at-large in its support of evidence-based practice. We present the network's infrastructure, development, and several examples that highlight the benefits of a clinical research network. We suggest that the network structure is ideal for building research capacity and fostering multisite, multiinvestigator clinical research projects designed to generate evidence for the efficacy of rehabilitation interventions.

Report of the 1st meeting of the "Vienna Initiative to Save European Academic Research (VISAER)".

PubMed

Druml, Christiane; Singer, Ernst A; Wolzt, Michael

2006-04-01

The European Directive 2001/20/EC ("Clinical Trials Directive") was aimed at simplifying and harmonising European clinical research. The directive's attempt represents an important step because many European Member States lack national laws that specifically address details of research, but the goal has been only partly achieved. For academic investigators doing national or multi-national research the new European law and the requirements following its implementation are likely to have the opposite effect. Some areas seem to be of particular concern: trial sponsorship, the ethical review process, the participation of patients who are temporarily not able to consent in clinical trials, in particular the informed consent process, an accepted European registry for all clinical trials, insurance and pharmacovigilance. Furthermore there are fundamental problems of the conduct of clinical trials that could have been foreseen at the time of implementation of the new law, which are impeding academic basic clinical research. The bureaucratic burden for academic investigators has tremendously increased without representing any contribution to patients' safety or to the scientific value of research. Furthermore some large European academic trials cannot be conducted anymore due to the new regulations. This result in a reduction in the number of trials and additionally in a reduction in the number of patients enrolled in a study. European research and thus European patients will suffer from the loss of potential benefits of research. The Vienna Initiative to Save European Academic Research (VISEAR) brings together leading stakeholders from academic research groups and interested parties from industry, international organisations and regulatory authorities to focus on the issues of concern regarding the organisational and funding of academic clinical research in order to improve the development and use of medicines in Europe. The first step of the initiative was a meeting held on May 30, 2005 in Vienna. The resumés of the six parallel working groups are presented in this supplement of the Wiener Klinische Wochenschrift, a position paper with recommendations in relation to the EU Clinical Trials Directive and medical research involving incapacitated adults has been published separately.

Conducting HIV Research in Racial and Ethnic Minority Communities: Building a Successful Interdisciplinary Research Team

PubMed Central

Polanco, Frinny R.; Dominguez, Dinora C.; Grady, Christine; Stoll, Pamela; Ramos, Catalina; Mican, JoAnn M.; Miranda-Acevedo, Robert; Morgan, Marcela; Aizvera, Jeasmine; Purdie, Lori; Koziol, Deloris; Rivera-Goba, Migdalia V.

2011-01-01

HIV infection occurs in disproportionately high rates among racial and ethnic minorities in the United States, making it imperative that individuals from these groups be included in research studies. Unfortunately, it is often difficult to recruit HIV-infected Hispanics and African Americans into clinical trials, but a skilled interdisciplinary team that includes researchers with racial and ethnic diversity can help. This article describes a successful approach for building an interdisciplinary team that values the participation of racial and ethnic minorities in clinical trials and that has the skills to work with these groups. The success of the Adelante (a Spanish word meaning forward) Team can be attributed to team members who actively participate in decision-making, are empowered, and function in a cohesive manner. Successful research teams build relationships with research participants in order to increase the probability that racial and ethnic minorities will enroll and participate fully in research. PMID:21277228

Conducting HIV research in racial and ethnic minority communities: building a successful interdisciplinary research team.

PubMed

Polanco, Frinny R; Dominguez, Dinora C; Grady, Christine; Stoll, Pamela; Ramos, Catalina; Mican, Joann M; Miranda-Acevedo, Robert; Morgan, Marcela; Aizvera, Jeasmine; Purdie, Lori; Koziol, Deloris; Rivera-Goba, Migdalia V

2011-01-01

HIV infection occurs in disproportionately high rates among racial and ethnic minorities in the United States, making it imperative that individuals from these groups be included in research studies. However, it is often difficult to recruit HIV-infected Hispanics and African Americans in clinical trials, but a skilled interdisciplinary team that includes researchers with racial and ethnic diversity can help. This article describes a successful approach for building an interdisciplinary team that values the participation of racial and ethnic minorities in clinical trials and has the skills to work with these groups. The success of the Adelante (a Spanish word meaning forward) Team can be attributed to team members who actively participate in decision-making, are empowered, and function in a cohesive manner. Successful research teams build relationships with research participants to increase the probability that racial and ethnic minorities will enroll and participate fully in research. Published by Elsevier Inc.

[Freiburg keratoconus registry : Example of application of smart data for clinical research and inititial results].

PubMed

Lang, S J; Böhringer, D; Reinhard, T

2016-06-01

Keratoconus is a progressive corneal disease with thinning and scarring of the cornea. Diagnostic and treatment options are usually evaluated in large prospective or retrospective trials. Big data and smart data provide the possibility to analyze routine data for clinical research. In this article we report the generation of a monocentric keratoconus registry by means of computerized data analysis of routine data. This demonstrates the potential of clinical research by means of routine data. A "clinical data warehouse" was created from all available routine electronic data. At the time of first presentation, each eye was classified into one out of four categories: suspected, early disease, late disease and status postkeratoplasty. Through integration of multiple data sources the clinical course for each patient was documented in the registry. A total of 3681 eyes from 1841 patients were included. The median follow-up time was 0.54 years. Patient age was higher in the groups with more severe stages of keratoconus, the proportion of female patients was higher in the group of suspected keratoconus and patient age and male to female ratios showed statistically significant differences between the groups (p < 0.001). We were able to create a "clinical data warehouse" by linking multiple data sources and normalizing the data. With this tool we established a novel, monocentric keratoconus registry. Only the grading of disease severity and the exclusion of false positive results were carried out manually. In our opinion establishing a structured clinical data warehouse has a huge potential for clinical and retrospective studies and proves the value of the Smart Data concept.

Overlap Between Autism Spectrum Disorders and Attention Deficit Hyperactivity Disorder: Searching for Distinctive/Common Clinical Features.

PubMed

Craig, Francesco; Lamanna, Anna Linda; Margari, Francesco; Matera, Emilia; Simone, Marta; Margari, Lucia

2015-06-01

Recent studies support several overlapping traits between autism spectrum disorders (ASD) and attention-deficit/hyperactivity disorder (ADHD), assuming the existence of a combined phenotype. The aim of our study was to evaluate the common or distinctive clinical features between ASD and ADHD in order to identify possible different phenotypes that could have a clinical value. We enrolled 181 subjects divided into four diagnostic groups: ADHD group, ASD group, ASD+ADHD group (that met diagnostic criteria for both ASD and ADHD), and control group. Intelligent quotient (IQ), emotional and behavior problems, ADHD symptoms, ASD symptoms, and adaptive behaviors were investigated through the following test: Wechsler Intelligence Scale for Children, Wechsler Preschool and Primary Scale of Intelligence or Leiter International Performances Scale Revised, Child Behavior Checklist, Conners' Rating Scales-Revised, SNAP-IV Rating Scale, the Social Communication Questionnaire, Vineland Adaptive Behavior Scales. The ASD+ADHD group differs from ADHD or ASD in some domains such as lower IQ mean level and a higher autistic symptoms severity. However, the ASD+ADHD group shares inattention and hyperactivity deficit and some emotional and behavior problems with the ADHD group, while it shares adaptive behavior impairment with ASD group. These findings provide a new understanding of clinical manifestation of ASD+ADHD phenotype, they may also inform a novel treatment target. © 2015 The Authors Autism Research published by Wiley Periodicals, Inc. on behalf of International Society for Autism Research.

Experience inheritance from famous specialists based on real-world clinical research paradigm of traditional Chinese medicine.

PubMed

Song, Guanli; Wang, Yinghui; Zhang, Runshun; Liu, Baoyan; Zhou, Xuezhong; Zhou, Xiaji; Zhang, Hong; Guo, Yufeng; Xue, Yanxing; Xu, Lili

2014-09-01

The current modes of experience inheritance from famous specialists in traditional Chinese medicine (TCM) include master and disciple, literature review, clinical-epidemiology-based clinical research observation, and analysis and data mining via computer and database technologies. Each mode has its advantages and disadvantages. However, a scientific and instructive experience inheritance mode has not been developed. The advent of the big data era as well as the formation and practice accumulation of the TCM clinical research paradigm in the real world have provided new perspectives, techniques, and methods for inheriting experience from famous TCM specialists. Through continuous exploration and practice, the research group proposes the innovation research mode based on the real-world TCM clinical research paradigm, which involves the inheritance and innovation of the existing modes. This mode is formulated in line with its own development regularity of TCM and is expected to become the main mode of experience inheritance in the clinical field.

Promoting physical therapists’ of research evidence to inform clinical practice: part 1 - theoretical foundation, evidence, and description of the PEAK program

PubMed Central

2014-01-01

Background There is a need for theoretically grounded and evidence-based interventions that enhance the use of research evidence in physical therapist practice. This paper and its companion paper introduce the Physical therapist-driven Education for Actionable Knowledge translation (PEAK) program, an educational program designed to promote physical therapists’ integration of research evidence into clinical decision-making. The pedagogical foundations for the PEAK educational program include Albert Bandura’s social cognitive theory and Malcolm Knowles’s adult learning theory. Additionally, two complementary frameworks of knowledge translation, the Promoting Action on Research Implementation in Health Services (PARiHS) and Knowledge to Action (KTA) Cycle, were used to inform the organizational elements of the program. Finally, the program design was influenced by evidence from previous attempts to facilitate the use of research in practice at the individual and organizational levels. Discussion The 6-month PEAK program consisted of four consecutive and interdependent components. First, leadership support was secured and electronic resources were acquired and distributed to participants. Next, a two-day training workshop consisting of didactic and small group activities was conducted that addressed the five steps of evidence based practice. For five months following the workshop, participants worked in small groups to review and synthesize literature around a group-selected area of common clinical interest. Each group contributed to the generation of a “Best Practices List” - a list of locally generated, evidence-based, actionable behaviors relevant to the groups’ clinical practice. Ultimately, participants agreed to implement the Best Practices List in their clinical practice. Summary This, first of two companion papers, describes the underlying pedagogical theories, knowledge translation frameworks, and research evidence used to derive the PEAK program – an educational program designed to promote the use of research evidence to inform physical therapist practice. The four components of the program are described in detail. The companion paper reports the results of a mixed methods feasibility analysis of this complex educational intervention. PMID:24965501

The ethics and regulatory landscape of including vulnerable populations in pragmatic clinical trials

PubMed Central

Welch, Mary Jane; Lally, Rachel; Miller, Jennifer E; Pittman, Stephanie; Brodsky, Lynda; Caplan, Arthur L; Uhlenbrauck, Gina; Louzao, Darcy M; Fischer, James H; Wilfond, Benjamin

2015-01-01

Policies have been developed to protect vulnerable populations in clinical research, particularly the US federal research regulations (45 CFR 46 subparts B, C, and D). These policies generally recognize vulnerable populations to include pregnant women, fetuses, neonates, children, prisoners, persons with physical handicaps or mental disabilities, and disadvantaged persons. The aim has been to protect these populations from harm, often by creating regulatory and ethical checks that may limit their participation in many clinical trials. The recent increase in pragmatic clinical trials (PCTs) raises at least two questions about this approach. First, is exclusion itself a harm to vulnerable populations, as these groups may be denied access to understanding how health interventions work for them in clinical settings? Second, are groups considered vulnerable in traditional clinical trials also vulnerable in PCTs? We argue first, that excluding vulnerable subjects from participation in PCTs can be harmful by preventing acquisition of data to meaningfully inform clinical decision-making in the future. Second, we argue that protections for vulnerable subjects in traditional clinical trial settings may not be translatable, feasible, or even ethical to apply in PCTs. We conclude by offering specific recommendations for appropriately protecting vulnerable research subjects in PCTs, focusing on pregnant women, fetuses, neonates, children, prisoners, persons with physical handicaps or mental disabilities, and disadvantaged persons. PMID:26374681

Manifesto: towards a clinically-oriented psychometrics.

PubMed

Vickers, Andrew J; Chen, Ling Y

2017-04-26

New technologies to collect patient - reported outcomes have substantially solved the challenge of integrating a questionnaire in a busy clinical practice. At Memorial Sloan Kettering, we have been collecting patient reported outcomes electronically for many years. Our experience confirms the predicted benefits of obtaining patient reported outcomes but has also raised serious concerns about whether instruments developed for the research setting are appropriate for routine clinical use. We summarize four principles for a clinically - relevant psychometrics. First, minimize patient burden: the use of a large number of items for a single domain may be of interest for research but additional items have little clinical utility. Secondly, use simplified language: patients who do not have good language skills are typically excluded from research studies but will nonetheless present in clinical practice. Third, avoid dumb questions: many questionnaire items are inappropriate when applied to a more general population. Fourth, what works for the group may not work for the individual: group level statistics used to validate survey instruments can obscure problems when applied to a subgroup of patients. There is a need for a clinically-oriented psychometrics to help design, test, and evaluate questionnaires that would be used in routine practice. Developing statistical methods to optimize questionnaires will be highly challenging but needed to bring the potential of patient reported outcomes into widespread clinical use.

Increased prevalence of vegetarianism among women with eating pathology.

PubMed

Zuromski, Kelly L; Witte, Tracy K; Smith, April R; Goodwin, Natalie; Bodell, Lindsay P; Bartlett, Mary; Siegfried, Nicole

2015-12-01

Prior research has established a link between vegetarianism and disordered eating but has typically sampled vegetarians. This study examined prevalence of and variables related to vegetarianism in three samples with varying severity of eating pathology. Sample 1 consisted of female undergraduates who denied history of or current disordered eating (i.e., nonclinical; n=73), or engaged in disordered eating over past month (i.e., subclinical; n=136). Sample 2 included 69 female patients receiving residential treatment at an eating disorder center (i.e., clinical sample). Differences between groups were analyzed using Fisher's exact test. The prevalence of lifetime vegetarianism was lowest in the nonclinical group (6.80%) and highest in the clinical group (34.80%), with the subclinical group falling in between (17.60%). According to Fisher's exact test, all pairwise comparisons between groups were statistically significant (p's<.05). Regarding current vegetarian status, the clinical group was more likely (11.10%) than both other groups to self-identify as current vegetarians. Endorsement of vegetarianism was highest among females with severe eating pathology. Future research should use longitudinal data to examine the temporal relationship between these variables, or other underlying factors that may contribute to the co-occurrence of eating pathology and vegetarianism. Clinically, endorsement of vegetarianism may also be an important variable to consider in treatment disordered eating. Copyright © 2015 Elsevier Ltd. All rights reserved.

SCN8A encephalopathy: Research progress and prospects.

PubMed

Meisler, Miriam H; Helman, Guy; Hammer, Michael F; Fureman, Brandy E; Gaillard, William D; Goldin, Alan L; Hirose, Shinichi; Ishii, Atsushi; Kroner, Barbara L; Lossin, Christoph; Mefford, Heather C; Parent, Jack M; Patel, Manoj; Schreiber, John; Stewart, Randall; Whittemore, Vicky; Wilcox, Karen; Wagnon, Jacy L; Pearl, Phillip L; Vanderver, Adeline; Scheffer, Ingrid E

2016-07-01

On April 21, 2015, the first SCN8A Encephalopathy Research Group convened in Washington, DC, to assess current research into clinical and pathogenic features of the disorder and prepare an agenda for future research collaborations. The group comprised clinical and basic scientists and representatives of patient advocacy groups. SCN8A encephalopathy is a rare disorder caused by de novo missense mutations of the sodium channel gene SCN8A, which encodes the neuronal sodium channel Nav 1.6. Since the initial description in 2012, approximately 140 affected individuals have been reported in publications or by SCN8A family groups. As a result, an understanding of the severe impact of SCN8A mutations is beginning to emerge. Defining a genetic epilepsy syndrome goes beyond identification of molecular etiology. Topics discussed at this meeting included (1) comparison between mutations of SCN8A and the SCN1A mutations in Dravet syndrome, (2) biophysical properties of the Nav 1.6 channel, (3) electrophysiologic effects of patient mutations on channel properties, (4) cell and animal models of SCN8A encephalopathy, (5) drug screening strategies, (6) the phenotypic spectrum of SCN8A encephalopathy, and (7) efforts to develop a bioregistry. A panel discussion of gaps in bioregistry, biobanking, and clinical outcomes data was followed by a planning session for improved integration of clinical and basic science research. Although SCN8A encephalopathy was identified only recently, there has been rapid progress in functional analysis and phenotypic classification. The focus is now shifting from identification of the underlying molecular cause to the development of strategies for drug screening and prioritized patient care. Wiley Periodicals, Inc. © 2016 International League Against Epilepsy.

SCN8A encephalopathy: Research progress and prospects

PubMed Central

Meisler, Miriam H.; Helman, Guy; Hammer, Michael F.; Fureman, Brandy E.; Gaillard, William D.; Goldin, Alan L.; Hirose, Shinichi; Ishii, Atsushi; Kroner, Barbara L.; Lossin, Christoph; Mefford, Heather C.; Parent, Jack M.; Patel, Manoj; Schreiber, John; Stewart, Randall; Whittemore, Vicky; Wilcox, Karen; Wagnon, Jacy L; Pearl, Phillip L.; Vanderver, Adeline; Scheffer, Ingrid E.

2017-01-01

On April 21, 2015, the first SCN8A Encephalopathy Research Group convened in Washington, DC, to assess current research into clinical and pathogenic features of the disorder and prepare an agenda for future research collaborations. The group comprised clinical and basic scientists and representatives of patient advocacy groups. SCN8A encephalopathy is a rare disorder caused by de novo missense mutations of the sodium channel gene SCN8A, which encodes the neuronal sodium channel Nav1.6. Since the initial description in 2012, approximately 140 affected individuals have been reported in publications or by SCN8A family groups. As a result, an understanding of the severe impact of SCN8A mutations is beginning to emerge. Defining a genetic epilepsy syndrome goes beyond identification of molecular etiology. Topics discussed at this meeting included (1) comparison between mutations of SCN8A and the SCN1A mutations in Dravet syndrome, (2) biophysical properties of the Nav1.6 channel, (3) electrophysiologic effects of patient mutations on channel properties, (4) cell and animal models of SCN8A encephalopathy, (5) drug screening strategies, (6) the phenotypic spectrum of SCN8A encephalopathy, and (7) efforts to develop a bioregistry. A panel discussion of gaps in bioregistry, biobanking, and clinical outcomes data was followed by a planning session for improved integration of clinical and basic science research. Although SCN8A encephalopathy was identified only recently, there has been rapid progress in functional analysis and phenotypic classification. The focus is now shifting from identification of the underlying molecular cause to the development of strategies for drug screening and prioritized patient care. PMID:27270488

Challenges and Recommendations for Placebo Controls in Randomized Trials in Physical and Rehabilitation Medicine

PubMed Central

Fregni, Felipe; Imamura, Marta; Chien, Hsin Fen; Lew, Henry L.; Boggio, Paulo; Kaptchuk, Ted J; Riberto, Marcelo; Hsing, Wu Tu; Battistella, Linamara Rizzo; Furlan, Andrea

2010-01-01

Compared to other specialties, the field of Physical and Rehabilitation Medicine (PRM) has not received the deserved recognition from clinicians and researchers in the scientific community. One of the reasons is the lack of sound evidence to support the traditional PRM treatments. The best way to change this disadvantage is through well-conducted clinical research, such as the standard placebo or sham-controlled randomized clinical trials. Therefore, having placebo groups in clinical trials is essential to improve the level of evidence-based practice in PRM that ultimately translates in a better clinical care. To address the challenges for the use of placebo in PRM randomized clinical trials, and to create useful recommendations, we convened a working group during the inaugural International Symposium in Placebo (February 2009, in Sao Paulo, Brazil) in which the following topics were discussed: (1) current status of randomized clinical trials in PRM, (2) challenges for the use of placebo in PRM, (3) bioethical issues, (4) use of placebo in acupuncture trials and for the treatment of low-back pain, (5) mechanisms of placebo, and (6) insights from other specialties. The current article represents the consensus report from the working group. PMID:20090428

The Globalization of Cooperative Groups.

PubMed

Valdivieso, Manuel; Corn, Benjamin W; Dancey, Janet E; Wickerham, D Lawrence; Horvath, L Elise; Perez, Edith A; Urton, Alison; Cronin, Walter M; Field, Erica; Lackey, Evonne; Blanke, Charles D

2015-10-01

The National Cancer Institute (NCI)-supported adult cooperative oncology research groups (now officially Network groups) have a longstanding history of participating in international collaborations throughout the world. Most frequently, the US-based cooperative groups work reciprocally with the Canadian national adult cancer clinical trial group, NCIC CTG (previously the National Cancer Institute of Canada Clinical Trials Group). Thus, Canada is the largest contributor to cooperative groups based in the United States, and vice versa. Although international collaborations have many benefits, they are most frequently utilized to enhance patient accrual to large phase III trials originating in the United States or Canada. Within the cooperative group setting, adequate attention has not been given to the study of cancers that are unique to countries outside the United States and Canada, such as those frequently associated with infections in Latin America, Asia, and Africa. Global collaborations are limited by a number of barriers, some of which are unique to the countries involved, while others are related to financial support and to US policies that restrict drug distribution outside the United States. This article serves to detail the cooperative group experience in international research and describe how international collaboration in cancer clinical trials is a promising and important area that requires greater consideration in the future. Copyright © 2015 Elsevier Inc. All rights reserved.

The Globalization of Cooperative Groups

PubMed Central

Valdivieso, Manuel; Corn, Benjamin W.; Dancey, Janet E.; Wickerham, D. Lawrence; Horvath, L. Elise; Perez, Edith A.; Urton, Alison; Cronin, Walter M.; Field, Erica; Lackey, Evonne; Blanke, Charles D.

2015-01-01

The National Cancer Institute-supported adult cooperative oncology research groups (now officially Network groups) have a long-standing history of participating in international collaborations throughout the world. Most frequently, the U.S. based cooperative groups work reciprocally with the Canadian national adult cancer clinical trial group, NCIC CTG (previously the National Cancer Institute of Canada Clinical Trials Group). Thus, Canada is the largest contributor to cooperative groups based in the U.S., and vice versa. Although international collaborations have many benefits, they are most frequently utilized to enhance patient accrual to large phase III trials originating in the U.S. or Canada. Within the cooperative group setting, adequate attention has not been given to the study of cancers that are unique to countries outside the U.S. and Canada, such as those frequently associated with infections in Latin America, Asia and Africa. Global collaborations are limited by a number of barriers, some of which are unique to the countries involved, while others are related to financial support and to U.S. policies that restrict drug distribution outside the U.S. This manuscript serves to detail the cooperative group experience in international research and describe how international collaboration in cancer clinical trials is a promising and important area that requires greater consideration in the future. PMID:26433551

Recruitment and Retention of Pregnant Women Into Clinical Research Trials: An Overview of Challenges, Facilitators, and Best Practices

PubMed Central

Frew, Paula M.; Saint-Victor, Diane S.; Isaacs, Margaret Brewinski; Kim, Sonnie; Swamy, Geeta K.; Sheffield, Jeanne S.; Edwards, Kathryn M.; Villafana, Tonya; Kamagate, Ouda; Ault, Kevin

2014-01-01

Pregnant women are a vulnerable group who are needed in clinical research studies to advance prevention and treatment options for this population. Yet, pregnant women remain underrepresented in clinical research. Through the lens of the socioecological model, we highlight reported barriers and facilitators to recruitment and retention of pregnant women in studies that sought their participation. We trace historical, policy-based reasons for the exclusion of pregnant women in clinical studies to present-day rationale for inclusion of this group. The findings highlight why it has been difficult to recruit and retain this population over time. A body of literature suggests that integrative sampling and recruitment methods that leverage the influence and reach of prenatal providers will overcome recruitment challenges. We argue that these strategies, in combination with building strong engagement with existing community-based organizations, will enable teams to more effectively promote and retain pregnant women in future longitudinal cohort studies. PMID:25425718

The importance of clinical research skills according to PharmD students, first-year residents, and residency directors.

PubMed

Anderson, Heather D; Saseen, Joseph J

Research has a prominent role within the field of pharmacy practice. However, no studies have assessed the importance of research methods in pharmacy education from the perspective of students, residents, or residency directors. Questionnaires were administered online in spring 2014 to four respondent groups: University of Colorado fourth year PharmD (P4) students, post graduate year 1 (PGY1) residents, and PGY1 and post-graduate year 2 (PGY2) residency directors. Descriptive statistics were used to characterize respondents; t-tests and chi-square tests were used to compare groups of respondents. Respondents included 255 PGY1 residency directors, 155 PGY2 residency directors, 35 PGY1 residents, and 87 P4 students. Response rates ranged from 26% (residency directors) to nearly 60% (P4 students and PGY1 residents). PGY1 residents and PGY1/PGY2 residency directors ranked research experience lowest among ten characteristics with respect to their importance when competing for a residency or being a successful resident. Among six specific clinical research skills, PGY1 residents and PGY1/PGY2 residency directors ranked "identifying and writing a research question" as the most important for successfully completing a residency research project or when selecting a PGY1/PGY2 resident. Perceived importance of clinical research skills by P4 students, current residents, and residency program directors is low. This is in opposition to opinions from several national organizations that proclaim the importance of clinical research skills in doctor of pharmacy curricula. Pharmacy programs must continue to further develop clinical research skills and abilities of future graduates while being cognizant of these perception barriers when developing strategies to enhance research experiences within their curricular programs. Copyright © 2017 Elsevier Inc. All rights reserved.

Program History

Cancer.gov

Learn how the National Cancer Institute transitioned the former Cooperative Groups Program to the National Clinical Trials Network (NCTN) program. The NCTN gives funds and other support to cancer research organizations to conduct cancer clinical trials.

The high vaginal swab in general practice: clinical correlates of possible pathogens.

PubMed

Dykhuizen, R S; Harvey, G; Gould, I M

1995-06-01

Clinical features, diagnosis and treatment of 286 women whose high vaginal swabs (HVS) submitted by their general practitioners showed pure, heavy growth of Staphylococcus aureus, beta haemolytic streptococci groups A, C or G, Streptococcus milleri, Streptococcus pneumoniae or Haemophilus influenzae were analysed. Women with group A, C and G streptococci frequently had clinical vulvovaginitis and although the numbers were too small for statistical confirmation, S. pneumoniae and H. influenzae appeared to cause clinical disease as well. The association of S. aureus or S. milleri with clinical vulvovaginitis was much less convincing. It seems relevant for laboratories to report sensitivities for group A, C and G streptococci. Further research is needed to determine the pathogenicity of S. pneumoniae and H. influenzae.

Children's Oncology Group's 2013 blueprint for research: behavioral science.

PubMed

Noll, Robert B; Patel, Sunita K; Embry, Leanne; Hardy, Kristina K; Pelletier, Wendy; Annett, Robert D; Patenaude, Andrea; Lown, E Anne; Sands, Stephen A; Barakat, Lamia P

2013-06-01

Behavioral science has long played a central role in pediatric oncology clinical service and research. Early work focused on symptom relief related to side effects of chemotherapy and pain management related to invasive medical procedures. As survival rates improved, the focused has shifted to examination of the psychosocial impact, during and after treatment, of pediatric cancer and its treatment on children and their families. The success of the clinical trials networks related to survivorship highlights an even more critical role in numerous domains of psychosocial research and care. Within the cooperative group setting, the field of behavioral science includes psychologists, social workers, physicians, nurses, and parent advisors. The research agenda of this group of experts needs to focus on utilization of psychometrically robust measures to evaluate the impact of treatment on children with cancer and their families during and after treatment ends. Over the next 5 years, the field of behavioral science will need to develop and implement initiatives to expand use of standardized neurocognitive and behavior batteries; increase assessment of neurocognition using technology; early identification of at-risk children/families; establish standards for evidence-based psychosocial care; and leverage linkages with the broader behavioral health pediatric oncology community to translate empirically supported research clinical trials care to practice. Copyright © 2012 Wiley Periodicals, Inc.

Clinical and translational research capacity building needs in minority medical and health science Hispanic institutions.

PubMed

Estapé-Garrastazu, Estela S; Noboa-Ramos, Carlamarie; De Jesús-Ojeda, Lizbelle; De Pedro-Serbiá, Zulmarie; Acosta-Pérez, Edna; Camacho-Feliciano, Delia M

2014-10-01

A preliminary needs assessment was conducted among faculty and students of three minority medical and health science institutions comprising the Puerto Rico Clinical and Translational Research Consortium (PRCTRC). The Web-based survey was focused on evaluating the training interests in the clinical and translational research core areas and competencies developed by the National Institutes of Health-Clinical and Translational Sciences Award. The survey was the result of a team effort of three PRCTRC key function's leaderships: Multidisciplinary Training and Career Development, Tracking and Evaluation and Community Research and Engagement. The questionnaire included 45 items distributed across five content areas including demographics, research training needs, training activities coordination and knowledge about the services offered by the PRCTRC. Analysis of research needs includes a sample distribution according to professor, assistant/associate professor and graduate students. The thematic area with highest response rate among the three groups was: "Identify major clinical/public health problems and relevant translational research questions," with the competency "Identify basic and preclinical studies that are potential testable clinical research hypothesis." These preliminary results will guide the training and professional development of the new generation of clinical and translational researchers needed to eliminate health disparities. © 2014 The Authors. Clinical and Translational Science Published by Wiley Periodicals, Inc.

Guidance for Researchers Developing and Conducting Clinical Trials in Practice-based Research Networks (PBRNs)

PubMed Central

Dolor, Rowena J.; Schmit, Kristine M.; Graham, Deborah G.; Fox, Chester H.; Baldwin, Laura Mae

2015-01-01

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

Chest electrical impedance tomography examination, data analysis, terminology, clinical use and recommendations: consensus statement of the TRanslational EIT developmeNt stuDy group

PubMed Central

Frerichs, Inéz; Amato, Marcelo B P; van Kaam, Anton H; Tingay, David G; Zhao, Zhanqi; Grychtol, Bartłomiej; Bodenstein, Marc; Gagnon, Hervé; Böhm, Stephan H; Teschner, Eckhard; Stenqvist, Ola; Mauri, Tommaso; Torsani, Vinicius; Camporota, Luigi; Schibler, Andreas; Wolf, Gerhard K; Gommers, Diederik; Leonhardt, Steffen; Adler, Andy

2017-01-01

Electrical impedance tomography (EIT) has undergone 30 years of development. Functional chest examinations with this technology are considered clinically relevant, especially for monitoring regional lung ventilation in mechanically ventilated patients and for regional pulmonary function testing in patients with chronic lung diseases. As EIT becomes an established medical technology, it requires consensus examination, nomenclature, data analysis and interpretation schemes. Such consensus is needed to compare, understand and reproduce study findings from and among different research groups, to enable large clinical trials and, ultimately, routine clinical use. Recommendations of how EIT findings can be applied to generate diagnoses and impact clinical decision-making and therapy planning are required. This consensus paper was prepared by an international working group, collaborating on the clinical promotion of EIT called TRanslational EIT developmeNt stuDy group. It addresses the stated needs by providing (1) a new classification of core processes involved in chest EIT examinations and data analysis, (2) focus on clinical applications with structured reviews and outlooks (separately for adult and neonatal/paediatric patients), (3) a structured framework to categorise and understand the relationships among analysis approaches and their clinical roles, (4) consensus, unified terminology with clinical user-friendly definitions and explanations, (5) a review of all major work in thoracic EIT and (6) recommendations for future development (193 pages of online supplements systematically linked with the chief sections of the main document). We expect this information to be useful for clinicians and researchers working with EIT, as well as for industry producers of this technology. PMID:27596161

Identifying research priorities with nurses at a tertiary children's hospital in the United Kingdom.

PubMed

Williams, A; Sell, D; Oulton, K; Wilson, N; Wray, J; Gibson, F

2017-03-01

The objective of this study was to undertake a research priority setting exercise with the aim of maximizing efficiency and impact in research activity undertaken by nurses at one children's tertiary healthcare institution by ensuring the clinical staff directly shaped a coherent, transparent and consensus driven nurse-led research agenda. In Round 1, the research topics of 147 nurses were elicited using a modified nominal group technique as the consensus method. The number of participants in the 24 separate discussions ranged from 3 to 21, generating lists of between 6 and 23 topics. In Round 2, nurses from the clinical areas ranked topics of importance resulting in a set of four to five priorities. In Round 3, the divisional heads of nursing consulted with staff in all of their clinical areas to each finalize their five divisional priorities. The Nursing Research Working Group discussed and refined the divisions' priorities and voted on the final list to agree the top five research priorities for the organization. A total of 269 research topics were initially generated. Following three rounds of ranking and prioritizing, five priorities were agreed at Divisional level, and from these, the five top organizational priorities were selected. These were (i) understanding and improving all aspects of the patient journey through the hospital system; (ii) play; (iii) staff wellbeing, patient care and productivity; (iv) team work - linking to a more efficient service; and (v) supporting parents/parent pathway. Divisional priorities have been disseminated widely to clinical teams to inform a patient-specific nurse-led research agenda. Organizational priorities agreed upon have been disseminated through management structures and processes to ensure engagement at all levels. A subgroup of the Nursing Research Working Group has been delegated to take this work forward so that the agreed priorities continue to contribute towards shaping nurse-led research activity, thereby going some way to inform and embed an evidence-based culture of inquiry. © 2016 John Wiley & Sons Ltd.

Self-reported use of complementary and alternative medicine therapies in a reflexology randomized clinical trial.

PubMed

Wyatt, Gwen; Sikorskii, Alla; You, Mei

2013-01-01

According to the National Center for Complementary and Alternative Medicine (NCCAM), about one-third of American cancer patients have used complementary and alternative medicine (CAM). The objective of this secondary analysis was an assessment of the use of other CAM by women with advanced breast cancer who were undergoing chemotherapy and who participated in a randomized clinical trial (RCT) studying the safety and efficacy of reflexology. For this secondary analysis, the research team hypothesized an increased CAM use due to exposure to the reflexology trial. For this secondary analysis, the team conducted telephone interviews at baseline, wk 5, and wk 11 to assess the use of 23 common CAM therapies. The study took place at 14 medical oncology clinics across the Midwestern United States. Participants included women with advanced breast cancer who were undergoing chemotherapy and/or hormonal therapy. In the study related to this secondary analysis, the research team randomly assigned the women to one of three primary groups: (1) reflexology; (2) lay foot manipulation (LFM); and (3) control. In addition, the research team used two test groups to establish the study's protocol: (1) test reflexology and (2) test LFM. For this secondary analysis, the research team considered the two reflexology groups (test and intervention) and the two LFM groups (test and intervention) to be the active groups, comparing their use of CAM to the control group's use at the selected time points. The research team used a linear, mixed-effects model to analyze the number of therapies used at the three time points. The team performed t tests to compare therapy use at baseline for those women who completed the study vs those who dropped out. The team used the CAM-use instrument. In total, 385 women participated. The research team found no differences in CAM use for the active groups vs the control group over time or in those women who stayed in the study vs those who dropped out. The team found an increase in CAM use at wk 5 compared to baseline, followed by a decrease at wk 11; however, the time trends were the same in the active groups and the control group In women with advanced breast cancer, researchers can rely upon one assessment of CAM use during an RCT of a CAM therapy.

Use of consensus development to establish national research priorities in critical care

PubMed Central

Vella, Keryn; Goldfrad, Caroline; Rowan, Kathy; Bion, Julian; Black, Nick

2000-01-01

Objectives To test the feasibility of using a nominal group technique to establish clinical and health services research priorities in critical care and to test the representativeness of the group's views. Design Generation of topics by means of a national survey; a nominal group technique to establish the level of consensus; a survey to test the representativeness of the results. Setting United Kingdom and Republic of Ireland. Subjects Nominal group composed of 10 doctors (8 consultants, 2 trainees) and 2 nurses. Main outcome measure Level of support (median) and level of agreement (mean absolute deviation from the median) derived from a 9 point Likert scale. Results Of the 325 intensive care units approached, 187 (58%) responded, providing about 1000 suggestions for research. Of the 106 most frequently suggested topics considered by the nominal group, 37 attracted strong support, 48 moderate support and 21 weak support. There was more agreement after the group had met—overall mean of the mean absolute deviations from the median fell from 1.41 to 1.26. The group's views represented the views of the wider community of critical care staff (r=0.73, P<0.01). There was no significant difference in the views of staff from teaching or from non-teaching hospitals. Of the 37 topics that attracted the strongest support, 24 were concerned with organisational aspects of critical care and only 13 with technology assessment or clinical research. Conclusions A nominal group technique is feasible and reliable for determining research priorities among clinicians. This approach is more democratic and transparent than the traditional methods used by research funding bodies. The results suggest that clinicians perceive research into the best ways of delivering and organising services as a high priority. PMID:10753149

Reflections on practitioner-researcher collaborative inquiry.

PubMed

Stockton, Rex; Morran, Keith

2010-04-01

We offer comments regarding two articles in this issue, one titled "Bridging the Practitioner-Scientist Gap in Group Psychotherapy Research" and a complementary article providing the results of a survey, entitled "A Survey of Canadian Group Psychotherapist Association Members' Perceptions of Psychotherapy Research." We also make several recommendations for collaborative research between practitioners and scientists, such as the inclusion of clinicians on the research team, practice research networks, and improved approaches to communicating clinically relevant research findings. Also discussed are reflections and recommendations from the authors' experience as scientist-practitioners.

A Tutorial on Multiblock Discriminant Correspondence Analysis (MUDICA): A New Method for Analyzing Discourse Data from Clinical Populations

ERIC Educational Resources Information Center

Williams, Lynne J.; Abdi, Herve; French, Rebecca; Orange, Joseph B.

2010-01-01

Purpose: In communication disorders research, clinical groups are frequently described based on patterns of performance, but researchers often study only a few participants described by many quantitative and qualitative variables. These data are difficult to handle with standard inferential tools (e.g., analysis of variance or factor analysis)…

Theory-driven group-based complex intervention to support self-management of osteoarthritis and low back pain in primary care physiotherapy: protocol for a cluster randomised controlled feasibility trial (SOLAS).

PubMed

Hurley, Deirdre A; Hall, Amanda M; Currie-Murphy, Laura; Pincus, Tamar; Kamper, Steve; Maher, Chris; McDonough, Suzanne M; Lonsdale, Chris; Walsh, Nicola E; Guerin, Suzanne; Segurado, Ricardo; Matthews, James

2016-01-21

International clinical guidelines consistently endorse the promotion of self-management (SM), including physical activity for patients with chronic low back pain (CLBP) and osteoarthritis (OA). Patients frequently receive individual treatment and advice to self-manage from physiotherapists in primary care, but the successful implementation of a clinical and cost-effective group SM programme is a key priority for health service managers in Ireland to maximise long-term outcomes and efficient use of limited and costly resources. This protocol describes an assessor-blinded cluster randomised controlled feasibility trial of a group-based education and exercise intervention underpinned by self-determination theory designed to support an increase in SM behaviour in patients with CLBP and OA in primary care physiotherapy. The primary care clinic will be the unit of randomisation (cluster), with each clinic randomised to 1 of 2 groups providing the Self-management of Osteoarthritis and Low back pain through Activity and Skills (SOLAS) intervention or usual individual physiotherapy. Patients are followed up at 6 weeks, 2 and 6 months. The primary outcomes are the (1) acceptability and demand of the intervention to patients and physiotherapists, (2) feasibility and optimal study design/procedures and sample size for a definitive trial. Secondary outcomes include exploratory analyses of: point estimates, 95% CIs, change scores and effect sizes in physical function, pain and disability outcomes; process of change in target SM behaviours and selected mediators; and the cost of the intervention to inform a definitive trial. This feasibility trial protocol was approved by the UCD Human Research Ethics-Sciences Committee (LS-13-54 Currie-Hurley) and research access has been granted by the Health Services Executive Primary Care Research Committee in January 2014. The study findings will be disseminated to the research, clinical and health service communities through publication in peer-reviewed journals, presentation at national and international academic and clinical conferences. ISRCTN 49875385; Pre-results. 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/

Preliminary Study of Resilience-Based Group Therapy for Improving the Functioning of Anxious Children

ERIC Educational Resources Information Center

Watson, Candice C.; Rich, Brendan A.; Sanchez, Lisa; O'Brien, Kelly; Alvord, Mary K.

2014-01-01

Background: There is a lack of research examining the feasibility of group psychotherapy interventions for anxious children in private clinical service settings. Furthermore, no research to date has examined the effectiveness of resilience-based interventions for helping children with anxiety disorders. Objective: The present study aims to examine…

Use of personal phones by senior nursing students to access health care information during clinical education: staff nurses' and students' perceptions.

PubMed

Wittmann-Price, Ruth A; Kennedy, Lynn D; Godwin, Catherine

2012-11-01

Research indicates that having electronic resources readily available increases learners' ability to make clinical decisions and confidence in patient care. This mixed-method, descriptive pilot study collected data about senior prelicensure nursing students using smartphones, a type of mobile electronic device (MED), in the clinical area. The smartphones contained nursing diagnosis, pharmacology, and laboratory information; an encyclopedia; and the MEDLINE database. Student (n = 7) data about smartphone use during a 10-week clinical rotation were collected via student-recorded usage logs and focus group recordings. Staff nurses' (n = 5) perceptions of students' use of smartphones for clinical educational resources were collected by anonymous survey. Both the focus group transcript and staff surveys were evaluated and the themes summarized by content analysis. Positive results and barriers to use, such as cost and technological comfort levels, are discussed. The results may help nurse educators and administrators initiate further research of MEDs as a clinical resource. Copyright 2012, SLACK Incorporated.

Point-of-Care Technologies for Precision Cardiovascular Care and Clinical Research

PubMed Central

King, Kevin; Grazette, Luanda P.; Paltoo, Dina N.; McDevitt, John T.; Sia, Samuel K.; Barrett, Paddy M.; Apple, Fred S.; Gurbel, Paul A.; Weissleder, Ralph; Leeds, Hilary; Iturriaga, Erin J.; Rao, Anupama; Adhikari, Bishow; Desvigne-Nickens, Patrice; Galis, Zorina S.; Libby, Peter

2016-01-01

Point-of-care technologies (POC or POCT) are enabling innovative cardiovascular diagnostics that promise to improve patient care across diverse clinical settings. The National Heart, Lung, and Blood Institute convened a working group to discuss POCT in cardiovascular medicine. The multidisciplinary working group, which included clinicians, scientists, engineers, device manufacturers, regulatory officials, and program staff, reviewed the state of the POCT field; discussed opportunities for POCT to improve cardiovascular care, realize the promise of precision medicine, and advance the clinical research enterprise; and identified barriers facing translation and integration of POCT with existing clinical systems. A POCT development roadmap emerged to guide multidisciplinary teams of biomarker scientists, technologists, health care providers, and clinical trialists as they: 1) formulate needs assessments; 2) define device design specifications; 3) develop component technologies and integrated systems; 4) perform iterative pilot testing; and 5) conduct rigorous prospective clinical testing to ensure that POCT solutions have substantial effects on cardiovascular care. PMID:26977455

Strategies to support recruitment of patients with life-limiting illness for research: the Palliative Care Research Cooperative Group.

PubMed

Hanson, Laura C; Bull, Janet; Wessell, Kathryn; Massie, Lisa; Bennett, Rachael E; Kutner, Jean S; Aziz, Noreen M; Abernethy, Amy

2014-12-01

The Palliative Care Research Cooperative Group (PCRC) is the first clinical trials cooperative for palliative care in the U.S. To describe barriers and strategies for recruitment during the inaugural PCRC clinical trial. The parent study was a multisite randomized controlled trial enrolling adults with life expectancy anticipated to be one to six months, randomized to discontinue statins (intervention) vs. to continue on statins (control). To study recruitment best practices, we conducted semistructured interviews with 18 site principal investigators (PIs) and clinical research coordinators (CRCs) and reviewed recruitment rates. Interviews covered three topics: 1) successful strategies for recruitment, 2) barriers to recruitment, and 3) optimal roles of the PI and CRC. All eligible site PIs and CRCs completed interviews and provided data on statin protocol recruitment. The parent study completed recruitment of 381 patients. Site enrollment ranged from 1 to 109 participants, with an average of 25 enrolled per site. Five major barriers included difficulty locating eligible patients, severity of illness, family and provider protectiveness, seeking patients in multiple settings, and lack of resources for recruitment activities. Five effective recruitment strategies included systematic screening of patient lists, thoughtful messaging to make research relevant, flexible protocols to accommodate patients' needs, support from clinical champions, and the additional resources of a trials cooperative group. The recruitment experience from the multisite PCRC yields new insights into methods for effective recruitment to palliative care clinical trials. These results will inform training materials for the PCRC and may assist other investigators in the field. Copyright © 2014 American Academy of Hospice and Palliative Medicine. Published by Elsevier Inc. All rights reserved.

Effects of additional team-based learning on students' clinical reasoning skills: a pilot study.

PubMed

Jost, Meike; Brüstle, Peter; Giesler, Marianne; Rijntjes, Michel; Brich, Jochen

2017-07-14

In the field of Neurology good clinical reasoning skills are essential for successful diagnosing and treatment. Team-based learning (TBL), an active learning and small group instructional strategy, is a promising method for fostering these skills. The aim of this pilot study was to examine the effects of a supplementary TBL-class on students' clinical decision-making skills. Fourth- and fifth-year medical students participated in this pilot study (static-group comparison design). The non-treatment group (n = 15) did not receive any additional training beyond regular teaching in the neurology course. The treatment group (n = 11) took part in a supplementary TBL-class optimized for teaching clinical reasoning in addition to the regular teaching in the neurology course. Clinical decision making skills were assessed using a key-feature problem examination. Factual and conceptual knowledge was assessed by a multiple-choice question examination. The TBL-group performed significantly better than the non-TBL-group (p = 0.026) in the key-feature problem examination. No significant differences between the results of the multiple-choice question examination of both groups were found. In this pilot study participants of a supplementary TBL-class significantly improved clinical decision-making skills, indicating that TBL may be an appropriate method for teaching clinical decision making in neurology. Further research is needed for replication in larger groups and other clinical fields.

[Research on antiemetics: an Italian model of success].

PubMed

Roila, F

1998-01-01

At the beginning of the 80's the Italian Group for Clinical Research (G.O.I.R.C.) identified chemotherapy-induced nausea and vomiting as one of the most distressing adverse events, and decided to plan and execute clinical trials on antiemetics in order to reduce this negative impact on patients. Therefore, some consecutive double-blind randomized trials were conducted on cisplatin-treated patients. The first was a dose-finding study on four different high-doses of domperidone, followed by a study comparing two different high-doses of metoclopramide, and a study comparing the addition of a corticosteroid to high-dose metoclopramide with respect to metoclopramide alone. Finally, a study demonstrating that a combination of a higher dose of metoclopramide (3 mg/kg x 2) plus dexamethasone and diphenhydramine was significantly superior with respect to a lower dose of metoclopramide (1 mg/kg x 4) combined with methylprednisolone was carried out. With the introduction of the 5-HT3 receptor antagonists the interest for antiemetic therapy increased and other Italian gynecological and medical oncology centres became involved in the antiemetic research. The Italian Group for Antiemetic Research was formed in 90's and its first study demonstrated the superiority of a combination of a 5-HT3 receptor antagonist plus dexamethasone with respect to the standard three drug combination of high doses of metoclopramide in the prevention of cisplatin-induced acute emesis. In the following years, the Group contributed to the identification of the best antiemetic prophylaxis for acute emesis induced by moderately emetogenic chemotherapy, and for delayed emesis induced by cisplatin. Also a drug utilization review on antiemetics in clinical practice has recently been carried out. Today, the interest of the Group is concentrated in studying the optimal antiemetic prophylaxis for delayed emesis induced by moderately emetogenic chemotherapy. The rules always followed by the Italian Group for Antiemetic Research are: --complete independence of judgement on the efficacy and the tolerability of antiemetic drugs from the pharmaceutical companies; --priority of ethical problems in designing clinical trials; --strict adherence to the methodological problems of antiemetic research and--complete autonomy concerning the study planned, the data computerization and the data elaboration. In the last twelve years approximately 70 Italian centres have enrolled their patients into the studies of the Italian Group for Antiemetic Research.

Barriers and facilitators to participation of minorities in clinical trials.

PubMed

Schmotzer, Geri L

2012-01-01

Historically, researchers have experienced difficulties with the recruitment of underrepresented populations, especially for women and minorities to cancer clinical trials. This has lead to marked health disparities among these groups. The purpose of this literature review is to investigate barriers and facilitators that provide explanations for the low participation rate of women and minorities in clinical trials. A search was conducted for published work in medical and social research from 1995 to 2008 using computerized databases: PubMed, CINAHL, and PsyclNFO. The following MeSH terms were used; clinical trials, minorities, minority groups, participation, recruitment, research subjects, and neoplasm. This netted a total of 43 articles, 22 of which were deemed appropriate for this article. Most striking throughout the literature was that barriers to trial participation were reported at an appreciably higher rate than facilitators. Health care provider barriers were captured by two themes: physician triage and physician knowledge. Patient barriers to trial participation emerged as reports of fear, mistrust of the medical community and the burden associated with trial participation. Facilitators to trial participation included physician enthusiasm and good communication skills, a good provider-patient relationship, having a perceived benefit, and feelings of altruism. This review provides a background into women and minorities' participation in clinical research. Patient recruitment into clinical trials is a complex process and there is limited research exploring the optimization of study recruitment. More information is needed to understand the issues surrounding the decision making process of the potential trial participant.

Comparison of the effect of web-based, simulation-based, and conventional training on the accuracy of visual estimation of postpartum hemorrhage volume on midwifery students: A randomized clinical trial

PubMed Central

Kordi, Masoumeh; Fakari, Farzaneh Rashidi; Mazloum, Seyed Reza; Khadivzadeh, Talaat; Akhlaghi, Farideh; Tara, Mahmoud

2016-01-01

Introduction: Delay in diagnosis of bleeding can be due to underestimation of the actual amount of blood loss during delivery. Therefore, this research aimed to compare the efficacy of web-based, simulation-based, and conventional training on the accuracy of visual estimation of postpartum hemorrhage volume. Materials and Methods: This three-group randomized clinical trial study was performed on 105 midwifery students in Mashhad School of Nursing and Midwifery in 2013. The samples were selected by the convenience method and were randomly divided into three groups of web-based, simulation-based, and conventional training. The three groups participated before and 1 week after the training course in eight station practical tests, then, the students of the web-based group were trained on-line for 1 week, the students of the simulation-based group were trained in the Clinical Skills Centre for 4 h, and the students of the conventional group were trained for 4 h presentation by researchers. The data gathering tool was a demographic questionnaire designed by the researchers and objective structured clinical examination. Data were analyzed by software version 11.5. Results: The accuracy of visual estimation of postpartum hemorrhage volume after training increased significantly in the three groups at all stations (1, 2, 4, 5, 6 and 7 (P = 0.001), 8 (P = 0.027)) except station 3 (blood loss of 20 cc, P = 0.095), but the mean score of blood loss estimation after training did not significantly different between the three groups (P = 0.95). Conclusion: Training increased the accuracy of estimation of postpartum hemorrhage, but no significant difference was found among the three training groups. We can use web-based training as a substitute or supplement of training along with two other more common simulation and conventional methods. PMID:27500175

An official American Thoracic Society research statement: comparative effectiveness research in pulmonary, critical care, and sleep medicine.

PubMed

Carson, Shannon S; Goss, Christopher H; Patel, Sanjay R; Anzueto, Antonio; Au, David H; Elborn, Stuart; Gerald, Joe K; Gerald, Lynn B; Kahn, Jeremy M; Malhotra, Atul; Mularski, Richard A; Riekert, Kristin A; Rubenfeld, Gordon D; Weaver, Terri E; Krishnan, Jerry A

2013-11-15

Comparative effectiveness research (CER) is intended to inform decision making in clinical practice, and is central to patient-centered outcomes research (PCOR). To summarize key aspects of CER definitions and provide examples highlighting the complementary nature of efficacy and CER studies in pulmonary, critical care, and sleep medicine. An ad hoc working group of the American Thoracic Society with experience in clinical trials, health services research, quality improvement, and behavioral sciences in pulmonary, critical care, and sleep medicine was convened. The group used an iterative consensus process, including a review by American Thoracic Society committees and assemblies. The traditional efficacy paradigm relies on clinical trials with high internal validity to evaluate interventions in narrowly defined populations and in research settings. Efficacy studies address the question, "Can it work in optimal conditions?" The CER paradigm employs a wide range of study designs to understand the effects of interventions in clinical settings. CER studies address the question, "Does it work in practice?" The results of efficacy and CER studies may or may not agree. CER incorporates many attributes of outcomes research and health services research, while placing greater emphasis on meeting the expressed needs of nonresearcher stakeholders (e.g., patients, clinicians, and others). CER complements traditional efficacy research by placing greater emphasis on the effects of interventions in practice, and developing evidence to address the needs of the many stakeholders involved in health care decisions. Stakeholder engagement is an important component of CER.

Perception Measurement in Clinical Trials of Schizophrenia: Promising Paradigms From CNTRICS

PubMed Central

Green, Michael F.; Butler, Pamela D.; Chen, Yue; Geyer, Mark A.; Silverstein, Steven; Wynn, Jonathan K.; Yoon, Jong H.; Zemon, Vance

2009-01-01

The third meeting of the Cognitive Neuroscience Treatment Research to Improve Cognition in Schizophrenia (CNTRICS) focused on selecting promising measures for each of the cognitive constructs selected in the first CNTRICS meeting. In the domain of perception, the 2 constructs of interest were gain control and visual integration. CNTRICS received 5 task nominations for gain control and three task nominations for visual integration. The breakout group for perception evaluated the degree to which each of these tasks met prespecified criteria. For gain control, the breakout group for perception believed that 2 of the tasks (prepulse inhibition of startle and mismatch negativity) were already mature and in the process of being incorporated into multisite clinical trials. However, the breakout group recommended that steady-state visual-evoked potentials be combined with contrast sensitivity to magnocellular vs parvocellular biased stimuli and that this combined task and the contrast-contrast effect task be recommended for translation for use in clinical trial contexts in schizophrenia research. For visual integration, the breakout group recommended the Contour Integration and Coherent Motion tasks for translation for use in clinical trials. This manuscript describes the ways in which each of these tasks met the criteria used by the breakout group to evaluate and recommend tasks for further development. PMID:19023123

Current Trends in Nursing Informatics: Results of an International Survey.

PubMed

Peltonen, Laura-Maria; Alhuwail, Dari; Ali, Samira; Badger, Martha K; Eler, Gabrielle Jacklin; Georgsson, Mattias; Islam, Tasneem; Jeon, Eunjoo; Jung, Hyunggu; Kuo, Chiu-Hsiang; Lewis, Adrienne; Pruinelli, Lisiane; Ronquillo, Charlene; Sarmiento, Raymond Francis; Sommer, Janine; Tayaben, Jude L; Topaz, Maxim

2016-01-01

Nursing informatics (NI) can help provide effective and safe healthcare. This study aimed to describe current research trends in NI. In the summer 2015, the IMIA-NI Students Working Group created and distributed an online international survey of the current NI trends. A total of 402 responses were submitted from 44 countries. We identified a top five NI research areas: standardized terminologies, mobile health, clinical decision support, patient safety and big data research. NI research funding was considered to be difficult to acquire by the respondents. Overall, current NI research on education, clinical practice, administration and theory is still scarce, with theory being the least common. Further research is needed to explain the impact of these trends and the needs from clinical practice.

Development and Implementation of Clinical Trial Protocol Templates at the National Institute of Allergy and Infectious Diseases

PubMed Central

Bridge, Heather; Smolskis, Mary; Bianchine, Peter; Dixon, Dennis O.; Kelly, Grace; Herpin, Betsey; Tavel, Jorge

2009-01-01

Background: A clinical research protocol document must reflect both sound scientific rationale as well as local, national and, when applicable, international regulatory and human subject protections requirements. These requirements originate from a variety of sources, undergo frequent revision and are subject to interpretation. Tools to assist clinical investigators in the production of clinical protocols could facilitate navigating these requirements and ultimately increase the efficiency of clinical research. Purpose: The National Institute of Allergy and Infectious Diseases (NIAID) developed templates for investigators to serve as the foundation for protocol development. These protocol templates are designed as tools to support investigators in developing clinical protocols. Methods: NIAID established a series of working groups to determine how to improve its capacity to conduct clinical research more efficiently and effectively. The Protocol Template Working Group was convened to determine what protocol templates currently existed within NIAID and whether standard NIAID protocol templates should be produced. After review and assessment of existing protocol documents and requirements, the group reached consensus about required and optional content, determined the format and identified methods for distribution as well as education of investigators in the use of these templates. Results: The templates were approved by the NIAID Executive Committee in 2006 and posted as part of the NIAID Clinical Research Toolkit[1]website for broad access. These documents require scheduled revisions to stay current with regulatory and policy changes. Limitations: The structure of any clinical protocol template, whether comprehensive or specific to a particular study phase, setting or design, affects how it is used by investigators. Each structure presents its own set of advantages and disadvantages. While useful, protocol templates are not stand-alone tools for creating an optimal protocol document but must be complemented by institutional resources and support. Education and guidance of investigators in the appropriate use of templates is necessary to ensure a complete yet concise protocol document. Due to changing regulatory requirements, clinical protocol templates cannot become static but require frequent revisions. Conclusions: Standard protocol templates that meet applicable regulations can be important tools to assist investigators in the effective conduct of clinical research, but they require dedicated resources and ongoing input from key stakeholders. PMID:19625326

[The Coordinating Centers for Clinical Trials (KKS) and the KKS Network: competence for clinical research].

PubMed

Ohmann, Christian; Bruns, Insa; Wolff, Stephanie

2010-01-01

The Network of the Coordination Centers for Clinical Trials (CTCs; Koordinierungszentren für Klinische Studien(KKS)) comprises 17 institutions working as scientific service provider for universities, study groups, the pharmaceutical and medical devices industry as well as additional clients associated with clinical research. The CTCs have established planning and conduct of clinical trials according to Good Clinical Practice (GCP) guidelines,with a wide range of study support in academia. One focus according to indications is cancer. Expertise in hematological/oncological research can be requested nationwide and cross-institutional. The KKS network currently cooperates with medical societies and other, even European networks in 20 countries and has been established as a strong platform for oncological trials. Copyright © 2010 S. Karger AG, Basel.

Use of a problem-based learning discussion format to teach anesthesiology residents research fundamentals.

PubMed

Sakai, Tetsuro; Karausky, Patricia L; Valenti, Shannon L; Sandusky, Susan L; Hirsch, Sandra C; Xu, Yan

2013-09-01

To present a new research problem-based learning discussion (PBLD) conference and to evaluate its effect on residents. Retrospective observational study of resident education before and after implementation of a research PBLD. Large U.S. academic anesthesiology department. 93 anesthesiology residents with research PBLD exposure in the academic year (AY) 2010 and AY 2011, and 85 residents without research PBLD exposure in AY 2008 and AY 2009. Since AY 2010, a PBLD format has been used to teach residents clinical research fundamentals. The annual 90-minute PBLD addressed residents' perceived barriers to research and introduced research resources available via the Clinical and Translational Science Institute (CTSI). Data recorded were: 1) number of residents who made CTSI consultation solicitations as a new investigator, and 2) number of new research projects proposed by the residents and designed with CTSI consultation. Each outcome was compared between the prePBLD group (AY 2008 [n=43] and AY 2009 [n=42]) and the postPBLD group (AY 2010 [n=43] and AY 2011 [n=50]). The number of residents who consulted the CTSI as new investigators increased from 4 of 85 residents (4.7%) in the prePBLD group to 13 of 93 residents (14.0%) in the postPBLD group (P = 0.042). The number of new research projects for which the residents consulted CTSI increased from 10 to 20 (100% increase). A PBLD format for research education of anesthesiology residents is effective. © 2013 Elsevier Inc. All rights reserved.

Retooling Institutional Support Infrastructure for Clinical Research

PubMed Central

Snyder, Denise C.; Brouwer, Rebecca N.; Ennis, Cory L.; Spangler, Lindsey L.; Ainsworth, Terry L.; Budinger, Susan; Mullen, Catherine; Hawley, Jeffrey; Uhlenbrauck, Gina; Stacy, Mark

2016-01-01

Clinical research activities at academic medical centers are challenging to oversee. Without effective research administration, a continually evolving set of regulatory and institutional requirements can detract investigator and study team attention away from a focus on scientific gain, study conduct, and patient safety. However, even when the need for research administration is recognized, there can be struggles over what form it should take. Central research administration may be viewed negatively, with individual groups preferring to maintain autonomy over processes. Conversely, a proliferation of individualized approaches across an institution can create inefficiencies or invite risk. This article describes experiences establishing a unified research support office at the Duke University School of Medicine based on a framework of customer support. The Duke Office of Clinical Research was formed in 2012 with a vision that research administration at academic medical centers should help clinical investigators navigate the complex research environment and operationalize research ideas. The office provides an array of services that have received high satisfaction ratings. The authors describe the ongoing culture change necessary for success of the unified research support office. Lessons learned from implementation of the Duke Office of Clinical Research may serve as a model for other institutions undergoing a transition to unified research support. PMID:27125563

A Quality Improvement Initiative to Increase Colorectal Cancer (CRC) Screening: Collaboration between a Primary Care Clinic and Research Team.

PubMed

Green, Beverly B; Fuller, Sharon; Anderson, Melissa L; Mahoney, Christine; Mendy, Peter; Powell, Susan L

2017-01-01

Multiple randomized controlled trials have demonstrated that mailed fecal testing programs are effective in increasing colorectal cancer screening participation. However, few healthcare organization in the US have Implemented such programs. Stakeholders from one clinic in an integrated healthcare system in Washington State initiated collaboration with researchers with expertise in CRC screening, aiming to increase screening rates at their clinic. Age-eligible individuals who were overdue for CRC screening and had previously completed a fecal test were randomized to receive mailed fecal immunochemical test kits (FIT) at the start of the project (Early) or 6 months later (Late). Outcomes included comparing FIT completion at 6 months by randomization group, and overall CRC screening rates at 12 months. We also assessed implementation facilitators and challenges. Overall 2,421 FIT tests were mailed at a cost of $10,739. At 6 months, FIT completion was significantly higher among the Early compared to the Late group (62% vs.47%, p <0.001). By 12 months, after both groups had received mailings, 71% in each group had completed a FIT. The clinic's overall CRC screening rate was 75.1% at baseline and 78.0% 12 months later. Key constructs associated with successful program implementation included strong stakeholder involvement, use of evidence-based strategies, simplicity, and low cost. Challenges included lack of a plan for maintaining the program. Collaboration between clinic stakeholders and researchers led to a successful project that rapidly increased CRC screening rates. However, institutional normalization of the program would be required to maintain it.

Department of Clinical Investigation Annual Research Progress Report, Fiscal Year 1993. Volume 1

DTIC Science & Technology

1993-10-01

monocytes, total periphernuclear cells, and alveolar macrophages from four study groups : patients with concurrent Mycobacterium tuberculosis (MTBI and...research design, similar to the Solomon Four Group design will be utilized to determine if the educational intervention provided has an impact on nurses...members with approved protocols: 173 Number of approved protocols held by this group : 230 Drug evaluation/comparison studies : 94 (Does not include

Stakeholders’ Views on Barriers to Research on Controversial Controlled Substances

PubMed Central

Rhodes; Andreae; Bourgiose; Indyk; Rhodes; Sacks

2017-01-01

Many diseases and disease symptoms still lack effective treatment. At the same time, certain controversial Schedule I drugs, such as heroin and cannabis, have been reputed to have considerable therapeutic potential for addressing significant medical problems. Yet, there is a paucity of U.S. clinical studies on the therapeutic uses of controlled drugs. For example, people living with HIV/AIDS experience a variety of disease- and medication-related symptoms. Their chronic pain is intense, frequent, and difficult to treat. Nevertheless, clinical trials of compassionate management for their chronic symptoms that should be a research priority, is stymied. We employed qualitative methods to develop an understanding of the barriers to research on potential therapeutic uses of Schedule I drugs so that they might be addressed. We elicited the perspectives of key stakeholder groups that would be involved in such studies: people living with HIV/AIDS, clinicians, and Institutional Review Board members. As we identified obstacles to research, we found all stakeholder groups to arrive at the same conclusion, that clinical research on the therapeutic potential of these drugs is ethically required. PMID:28001138

Myositis registries and biorepositories: powerful tools to advance clinical, epidemiologic and pathogenic research.

PubMed

Rider, Lisa G; Dankó, Katalin; Miller, Frederick W

2014-11-01

Clinical registries and biorepositories have proven extremely useful in many studies of diseases, especially rare diseases. Given their rarity and diversity, the idiopathic inflammatory myopathies, or myositis syndromes, have benefited from individual researchers' collections of cohorts of patients. Major efforts are being made to establish large registries and biorepositories that will allow many additional studies to be performed that were not possible before. Here, we describe the registries developed by investigators and patient support groups that are currently available for collaborative research purposes. We have identified 46 myositis research registries, including many with biorepositories, which have been developed for a wide variety of purposes and have resulted in great advances in understanding the range of phenotypes, clinical presentations, risk factors, pathogenic mechanisms, outcome assessment, therapeutic responses, and prognoses. These are now available for collaborative use to undertake additional studies. Two myositis patient registries have been developed for research, and myositis patient support groups maintain demographic registries with large numbers of patients available to be contacted for potential research participation. Investigator-initiated myositis research registries and biorepositories have proven extremely useful in understanding many aspects of these rare and diverse autoimmune diseases. These registries and biorepositories, in addition to those developed by myositis patient support groups, deserve continued support to maintain the momentum in this field as they offer major opportunities to improve understanding of the pathogenesis and treatment of these diseases in cost-effective ways.

Managing the interface between medical schools, hospitals, and clinical research.

PubMed

Gallin, J I; Smits, H L

1997-02-26

To review how academic health centers are coping with the changing environment of health care delivery with special emphasis on the impact of the changing health care system on clinical research. In response to Health and Human Services Secretary Donna Shalala's 1995 mandated review of the National Institutes of Health (NIH) Warren Grant Magnuson Clinical Center, an NIH review team visited 30 health facilities and government-owned organizations throughout the country. The review team determined what strategies are used by academic health centers to survive and thrive in the changing health care marketplace. The findings have implications for the NIH Clinical Center as well as academic health centers. Management strategies in successful academic health centers include streamlined governance structures whereby small groups of highly empowered group leaders allow institutions to move quickly and decisively; an active strategic planning process; close integration of hospital and medical school management; heavy investment in information systems; and new structures for patient care delivery. Successful centers are initiating discussions with third-party payers and are implementing new initiatives, such as establishing their own managed care organizations, purchasing physician practices, or owning hospitals. Other approaches include establishing revenue-generating centers for clinical research and new relations with industry. Attention to the infrastructure required to support the training and conduct of clinical research is essential for the future vitality of medical schools.

Consumer involvement in cancer research: example from a Cancer Network.

PubMed

Arain, Mubashir; Pyne, Sarah; Thornton, Nigel; Palmer, Susan; Sharma, Ricky A

2015-10-01

The involvement of consumers and the general public in improving cancer services is an important component of health services. However, consumer involvement in cancer research is relatively unexplored. The objective of this study was to explore different ways of involving consumers in cancer research in one regional network. Thames Valley Cancer Network Consumer Research Partnership (CRP) group was formed in 2009. The group consists of consumers and professionals to help in promoting consumer involvement in Cancer Research in the Thames Valley. This study evaluated the project of consumer involvement in cancer research in the Thames Valley from March 2010 to March 2011. We used different indices to judge the level of consumer involvement: number of projects involving consumers through the group, types of projects, level of involvement (ranged from consultation on research documents to collaborating in preparing grant applications) and the methods of involving consumers in cancer research. Fifteen projects were submitted to the CRP group during the 12-month period studied. Of these, eight projects were clinical trials, three were qualitative research projects, two were patients' surveys and two were non-randomized interventional studies. Seven projects requested consumer involvement on patient information sheets for clinical trials. Of these seven applications, three also requested consumers' help in designing research questionnaires and another three requested that consumers should be involved in their project management group. In addition, four projects involved consumers in the proposal development phase and another four projects asked for advice on how to increase trial recruitment, conduct patient interviews or help with grant applications. The creation of the CRP and this audit of its activity have documented consumer involvement in cancer research in the Thames Valley. We have clearly shown that consumers can be involved in designing and managing cancer research projects. © 2013 John Wiley & Sons Ltd.

Danish research-active clinical nurses overcome barriers in research utilization.

PubMed

Adamsen, Lis; Larsen, Kristian; Bjerregaard, Lene; Madsen, Jan K

2003-03-01

The aim of this study was to examine whether there was a difference between clinical nurses who were research-active, and clinical nurses who were nonresearch-active in utilization of research. A further aim was to identify the most significant barriers faced by a group of Danish clinical nurses in their use of research. Discrepancy between the improved quality of research results and the lack of implementing them was the starting point for a series of studies which showed the types of barriers clinical nurses found especially cumbersome when applying the research results of other researchers. This study investigates whether the clinical nurses' own engagement in research had any impact on their perception of research utilization. The study had an exploratory and descriptive design. Seventy-nine Danish clinical nurses participated and semi-structured interviewing was used as the research method. There was a statistically significant difference between the research-active and nonresearch-active nurses on various variables. The study showed that, to a larger extent, research-active nurses used evidence-based knowledge and were generally more internationally orientated. Furthermore, two important barriers for research utilization were identified by all 79 clinical nurses included in the study, i.e. 90% of the nurses explained that the quantity of research results was overwhelming, and 75% of them found that they were unable to evaluate the quality of the research. Clinical nurses, who were research-active themselves, experienced more success in overcoming some of the barriers, which existed in applying research to practice. The research potential found amongst clinical nurses in Denmark needed to be further supported through training and guidance in research methodology, establishing introductory stipends and part-time research positions. By doing so, some of the barriers affecting research utilization and the so-called theory-practice gap might be reduced. Further empirical studies, based on Giddens theory of sociological reflectivity, might see clinical nurses in a more serious light and simultaneously perceive them as producers of knowledge.

Integrating the hospital library with patient care, teaching and research: model and Web 2.0 tools to create a social and collaborative community of clinical research in a hospital setting.

PubMed

Montano, Blanca San José; Garcia Carretero, Rafael; Varela Entrecanales, Manuel; Pozuelo, Paz Martin

2010-09-01

Research in hospital settings faces several difficulties. Information technologies and certain Web 2.0 tools may provide new models to tackle these problems, allowing for a collaborative approach and bridging the gap between clinical practice, teaching and research. We aim to gather a community of researchers involved in the development of a network of learning and investigation resources in a hospital setting. A multi-disciplinary work group analysed the needs of the research community. We studied the opportunities provided by Web 2.0 tools and finally we defined the spaces that would be developed, describing their elements, members and different access levels. WIKINVESTIGACION is a collaborative web space with the aim of integrating the management of all the hospital's teaching and research resources. It is composed of five spaces, with different access privileges. The spaces are: Research Group Space 'wiki for each individual research group', Learning Resources Centre devoted to the Library, News Space, Forum and Repositories. The Internet, and most notably the Web 2.0 movement, is introducing some overwhelming changes in our society. Research and teaching in the hospital setting will join this current and take advantage of these tools to socialise and improve knowledge management.

[The effects of case-based learning using video on clinical decision making and learning motivation in undergraduate nursing students].

PubMed

Yoo, Moon-Sook; Park, Jin-Hee; Lee, Si-Ra

2010-12-01

The purpose of this study was to examine the effects of case-base learning (CBL) using video on clinical decision-making and learning motivation. This research was conducted between June 2009 and April 2010 as a nonequivalent control group non-synchronized design. The study population was 44 third year nursing students who enrolled in a college of nursing, A University in Korea. The nursing students were divided into the CBL and the control group. The intervention was the CBL with three cases using video. The controls attended a traditional live lecture on the same topics. With questionnaires objective clinical decision-making, subjective clinical decision-making, and learning motivation were measured before the intervention, and 10 weeks after the intervention. Significant group differences were observed in clinical decision-making and learning motivation. The post-test scores of clinical decision-making in the CBL group were statistically higher than the control group. Learning motivation was also significantly higher in the CBL group than in the control group. These results indicate that CBL using video is effective in enhancing clinical decision-making and motivating students to learn by encouraging self-directed learning and creating more interest and curiosity in learning.

A model for integrating clinical care and basic science research, and pitfalls of performing complex research projects for addressing a clinical challenge.

PubMed

Steck, R; Epari, D R; Schuetz, M A

2010-07-01

The collaboration of clinicians with basic science researchers is crucial for addressing clinically relevant research questions. In order to initiate such mutually beneficial relationships, we propose a model where early career clinicians spend a designated time embedded in established basic science research groups, in order to pursue a postgraduate qualification. During this time, clinicians become integral members of the research team, fostering long term relationships and opening up opportunities for continuing collaboration. However, for these collaborations to be successful there are pitfalls to be avoided. Limited time and funding can lead to attempts to answer clinical challenges with highly complex research projects characterised by a large number of "clinical" factors being introduced in the hope that the research outcomes will be more clinically relevant. As a result, the complexity of such studies and variability of its outcomes may lead to difficulties in drawing scientifically justified and clinically useful conclusions. Consequently, we stress that it is the basic science researcher and the clinician's obligation to be mindful of the limitations and challenges of such multi-factorial research projects. A systematic step-by-step approach to address clinical research questions with limited, but highly targeted and well defined research projects provides the solid foundation which may lead to the development of a longer term research program for addressing more challenging clinical problems. Ultimately, we believe that it is such models, encouraging the vital collaboration between clinicians and researchers for the work on targeted, well defined research projects, which will result in answers to the important clinical challenges of today. Copyright (c) 2010 Elsevier Ltd. All rights reserved.

An Ethno-medical Perspective on Research Participation: A Qualitative Pilot Study

PubMed Central

Calderón, José L.; Baker, Richard S.; Fabrega, Horacio; Conde, José G.; Hays, Ron D.; Fleming, Erik; Norris, Keith

2006-01-01

Background Recruitment of racial/ethnic minorities for clinical research continues to be problematic, yet critical to ensuring that research data will be applicable to diverse populations. There is a paucity of information about culturally appropriate methods for recruiting and retaining racial/ethnic minorities in research. Objective To cross-culturally assess perceptions of research participation by African American and immigrant Latinos living in the inner-city community of Watts, Los Angeles, California, using qualitative methods. Design Focus groups using ethnically matched moderators were convened with African American and immigrant Latino participants. Discussion was facilitated using a script that focused on perceived “feelings” and “perceptions” about research. Discussions were audiotaped, transcribed, and analyzed using manual and computerized statistically based software (mixed) methods. Results African Americans and immigrant Latinos shared several barriers and motivators to research. However, they also reported barriers and motivators to research that were distinct to each group. Latinos were more interested in healthcare and health information, and African Americans were more concerned with issues of trust and quality of care. Most participants said they would participate in research if they were better informed, or if they or a family member had an illness. Improving communication was reported as being important for motivating participation in clinical research. Overall, socioecologically and socioeconomically based domains were shared, whereas historically and/or socioculturally based domains were distinct. Conclusions Using an ethno-medical science model, we demonstrated that it is possible to identify shared barriers and motivators to research participation between 2 distinct cultural groups. This approach can be useful in developing targeted community-based strategies to increase minority participation in clinical trials. PMID:16926762

Minority recruitment in clinical trials: a conference at Tuskegee, researchers and the community.

PubMed

Fouad, M N; Partridge, E; Green, B L; Kohler, C; Wynn, T; Nagy, S; Churchill, S

2000-11-01

This article describes the planning, implementation, and evaluation of a 2-day conference designed to examine the factors related to the participation of African Americans in cancer clinical trials. Pre-conference formative evaluations (e.g., focus group discussions and key informant interviews with community leaders and health providers) were conducted in several rural and urban counties in the state of Alabama to determine African Americans' perceptions of participation in clinical research. The findings from these evaluations were used to develop a conference format and agenda. The 2-day conference included: (i) a pretest of African Americans' perceptions of cancer research, participation factors, and communication and recruitment issues; (ii) individual presentations high-lighting community leaders, church leaders, and researchers' perspectives regarding minority participation in research; (iii) working group discussions regarding the barriers and solutions to minority participation in research; and (iv) a posttest evaluation to measure changes in African Americans' perceptions of research. Several recruitment barriers and solutions were identified and reported by the working groups. Comparisons of the pretest and posttest measures showed significant (p > .05) and favorable shifts in the areas of perceptions of cancer research, participation factors, communication issues, and recruitment issues. Participation in the conference reflected a positive change in attitudes on these measures. However, the theme, "barriers that contributed to nonparticipation," did not show any significant changes during the two testing periods. The most critical lesson that resulted from this conference was the need for researchers and community members to have open dialogue about participation in research. This conference demonstrated that progress can be made when all parties are at the "table" and can be heard. In this model, community members proved to be valuable resources in providing researchers with information that was vital to the success of recruitment and retention studies and trials.

Does clinical equipoise apply to cluster randomized trials in health research?

PubMed Central

2011-01-01

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. Finally, clinical equipoise provides research ethics committees with formal and procedural guidelines that form an important part of the assessment of the benefits and harms of CRTs in health research. PMID:21569349

The impact of persistence with bisphosphonates on health resource utilization and fracture risk in the UK: a study of patient records from the UK Clinical Practice Research Datalink.

PubMed

Ferguson, Samara; Feudjo Tepie, Maurille; Taylor, Andrew; Roddam, Andrew; Critchlow, Cathy; Iqbal, Mazhar; Spangler, Leslie; Bayly, Jonathan

2016-02-01

Clinical trial data suggest that patients who have received bisphosphonates continue to benefit from them after discontinuation. However, data from real-world clinical practice are inconclusive. We assessed the impact of persistence and discontinuation on health resource utilization (HRU) and fracture rate in women who were prescribed oral bisphosphonates. The study used data from the UK Clinical Practice Research Datalink. Women aged 50 years or older with a first prescription of oral bisphosphonate therapy between January 2000 and December 2007 were included. Multivariate modelling compared rate ratios for fracture and HRU between patients who had discontinued medication (shorter persistence group) and patients who took their medication for longer (longer persistence group). The interactions of elapsed time (measured as 6-month intervals) with HRU and with fracture rate for all patients within paired groups were also assessed. Overall, 36 320 patients were included. Pairwise comparisons showed that HRU and fracture rates were lower in longer persistence groups than in shorter persistence groups. Analysis by 6-month interval showed that, across all patients in persistence group pairs, HRU significantly increased for each additional 6 months elapsed; trends towards increased risk of fracture were also seen. In contrast to results from clinical trials, in this patient population the protective effect of oral bisphosphonates after discontinuation was not sufficient to reduce HRU and fracture rates to the levels that would be seen if patients had continued on therapy. Reducing the rate of treatment discontinuation may decrease the burden that osteoporosis places on both patients and health care systems. © 2015 AMGEN Inc. Journal of Evaluation in Clinical Practice published by John Wiley & Sons, Ltd.

[Organization of clinical research: in general and visceral surgery].

PubMed

Schneider, M; Werner, J; Weitz, J; Büchler, M W

2010-04-01

The structural organization of research facilities within a surgical university center should aim at strengthening the department's research output and likewise provide opportunities for the scientific education of academic surgeons. We suggest a model in which several independent research groups within a surgical department engage in research projects covering various aspects of surgically relevant basic, translational or clinical research. In order to enhance the translational aspects of surgical research, a permanent link needs to be established between the department's scientific research projects and its chief interests in clinical patient care. Importantly, a focus needs to be placed on obtaining evidence-based data to judge the efficacy of novel diagnostic and treatment concepts. Integration of modern technologies from the fields of physics, computer science and molecular medicine into surgical research necessitates cooperation with external research facilities, which can be strengthened by coordinated support programs offered by research funding institutions.

An American Thoracic Society Official Research Statement: Future Directions in Lung Fibrosis Research.

PubMed

White, Eric S; Borok, Zea; Brown, Kevin K; Eickelberg, Oliver; Guenther, Andreas; Jenkins, R Gisli; Kolb, Martin; Martinez, Fernando J; Roman, Jesse; Sime, Patricia

2016-04-01

Pulmonary fibrosis encompasses a group of lung-scarring disorders that occur owing to known or unknown insults and accounts for significant morbidity and mortality. Despite intense investigation spanning decades, much remains to be learned about the natural history, pathophysiology, and biologic mechanisms of disease. To identify the most pressing research needs in the lung fibrosis community and to provide a roadmap of priorities to investigators, funding agencies, patient advocacy groups, and other interested stakeholders. An ad hoc international working group of the American Thoracic Society with experience in clinical, translational, and bench-based research in fibrotic lung diseases was convened. The group used an iterative consensus process to identify successes and challenges in pulmonary fibrosis research. The group identified five main priority areas in which substantial resources should be invested to advance our understanding and to develop novel therapies for patients with pulmonary fibrosis. These priorities include develop newer models of human lung fibrosis, engage current and new stakeholders to provide sustained funding for the initiatives, create a global infrastructure for storing patient-derived materials, establish collaborative preclinical and clinical research networks in fibrotic lung disease, and create a global lung fibrosis initiative that unites these multifaceted efforts into a single virtual umbrella structure. Despite recent advances in the treatment of some forms of lung fibrosis, many gaps in knowledge about natural history, pathophysiology, and treatment remain. Investment in the research priorities enumerated above will help address these shortcomings and enhance patient care worldwide.

What Latino Puerto Ricans and non-Latinos say when they talk about Alzheimer's disease.

PubMed

Karlawish, Jason; Barg, Frances K; Augsburger, Deborah; Beaver, James; Ferguson, Allison; Nunez, Jessica

2011-03-01

To discover whether Latino Puerto Rican and non-Latino communities differ in the words they use to talk about Alzheimer's disease (AD). Four groups of 30 persons per group defined by self-identified ethnicity and caregiver status: Latino Puerto Ricans and non-Latino Whites, who were either caregivers or non-caregivers completed free-listing exercises to identify the words they use when they describe AD causes, symptoms, caregiving, and research risks and benefits. Both Latino Puerto Ricans and non-Latino Whites recognize AD as a disease of memory loss and other cognitive problems. Although both groups used the term "sadness" to describe AD, non-Latino Whites did not feature emotional, behavioral, or psychological problems as among the causes of AD. Although all the groups' descriptions of a person who lives with and cares for a person with AD shared the word "loving," Latino Puerto Ricans focused on a good spouse who exercises intelligence, patience, and attention on behalf of the person with AD and did not use the term "caregiver." In contrast, non-Latino Whites typically used the term "caregiver." Both groups' lists shared words that describe research as presenting harms to an AD patient and requiring a commitment of time. Latino Puerto Ricans' lists suggested an understanding of research benefits akin to clinical care. Notable differences exist in how Latino Puerto Ricans and non-Latino Whites talk about AD and AD research. Clinicians, clinical investigators, and patient educators need to consider these differences when they conduct clinical care and research and design outreach and educational materials. Copyright © 2011 The Alzheimer's Association. Published by Elsevier Inc. All rights reserved.

Outcomes Evaluation of a Weekly Nurse Practitioner-Managed Symptom Management Clinic for Patients With Head and Neck Cancer Treated With Chemoradiotherapy

PubMed Central

Mason, Heidi; DeRubeis, Mary Beth; Foster, Jared C.; Taylor, Jeremy M.G.; Worden, Francis P.

2016-01-01

Purpose/Objectives To determine whether improved monitoring through close follow-up with a nurse practitioner (NP) could enhance treatment compliance and decrease frequency of hospitalizations. Design Retrospective chart review. Setting An academic National Cancer Institute–designated comprehensive cancer center. Sample 151 patients aged 45–65 years diagnosed with stage III or IV oropharyngeal cancer. Methods Patients were nonrandomized to one of two groups: a prechemotherapy clinic group and a weekly NP-led clinic group. After examination of descriptive statistics, multiple linear and logistic regressions were used to compare groups across patient outcomes. Main Research Variables Hospitalization, chemotherapy dose deviations, and chemotherapy treatment completion. Findings The average number of visits during traditional treatment was three and, after initiation of the NP-led clinic, the number was six. The hospitalization rate was 28% in the traditional clinic group compared to 12% in the NP-led group. The rate of chemotherapy dose deviations was 48% in the traditional clinic group compared to 6% in the NP-led clinic group. Forty-six percent of patients in the traditional clinic group received the full seven scheduled doses of chemotherapy compared to 90% of patients seen in the NP-led clinic group. Conclusions A weekly NP-led symptom management clinic reduces rates of hospitalization and chemotherapy dose deviations and increases chemotherapy completion in patients receiving intensive chemoradiotherapy for oropharyngeal cancer. Implications for Nursing Patients receiving chemoradiotherapy benefit from close monitoring for toxicities by NPs to successfully complete their treatment and avoid hospitalization. Knowledge Translation Early interventions to manage toxicities in patients with head and neck cancer can improve outcomes. NPs are in a key position to manage these toxicities and, when symptoms are controlled, costs are reduced. PMID:24007925

Role of the adrenal cortex and sodium in the pathogenesis of human hypertension.

PubMed Central

Genest, J.; Nowaczynski, W.; Boucher, R.; Kuchel, O.

1978-01-01

After 30 years of continuous research into the mechanisms of human hypertension, we summarize the results obtained by the members of the multidisciplinary research group on hypertension of the Clinical Research Institute of Montreal on the disturbances of minerlocorticoid activity in a rigorously selected group of patients with early, mild essential hypertension. We attempt to integrate these findings with those of many other groups working on other aspects of hypertensive cardiovascular diseases. On the assumption that the increased peripheral resistance responsible for hypertension results from an imbalance or a disturbance of the equilibrium between the sympathetic nervous system and norepinephrine on one hand, and the vascular tone, sensitivity and responsiveness of the arterial smooth muscle to norepinephrine and to angiotensin II on the other hand, three models that fit the experimental and clinical facts as known at present are described. PMID:343905

Current status of integrating information technologies into the clinical research enterprise within US academic health centers: strategic value and opportunities for investment.

PubMed

Turisco, Fran; Keogh, Diane; Stubbs, Connie; Glaser, John; Crowley, William F

2005-12-01

Little information exists about the incorporation of information technologies (ITs) into clinical research processes within US academic health centers (AHCs). Therefore, we queried a group of 37 leading AHCs regarding their current status and future plans in clinical research IT. The survey specifically inquired about the presence or absence of basic infrastructure and IT support requirements; individual applications needed to support study preparation, study conduct, and its administrative support; and integration of data from basic research, clinical trials, and the clinical information systems increasingly used in health care delivery. Of the 37 AHCs, 78% responded. All strongly agreed that a "state-of-the-art" clinical research IT program would be ideal today and will be essential tomorrow. Nonetheless, no AHC currently has an IT solution that even approached this ideal. No AHC reported having all of the essential management foundations (ie, a coherent vision, an overall strategy, a governance structure, and a dedicated budget) necessary to launch and sustain a truly successful implementation of a cohesive clinical research IT platform. Many had achieved breakthroughs in individual aspects of clinical research IT, for example, adverse event reporting systems or consent form templates. However, overall implementation of IT to support clinical research is uneven and insufficient. These data document a substantial gap in clinical research IT investments in leading US AHCs. Linking the clinical research IT enterprise with its clinical operations in a meaningful fashion remains a crucial strategic goal of AHCs. If they are to continue to serve as the "translational research engines" that our society expects, AHCs must recognize this gap and allocate substantial resource deployment to remedying this situation.

Association Between Lumbar Disc Degeneration and Propionibacterium acnes Infection: Clinical Research and Preliminary Exploration of Animal Experiment.

PubMed

Li, Bo; Dong, Zhe; Wu, Yongchao; Zeng, Ji; Zheng, Qixin; Xiao, Baojun; Cai, Xianyi; Xiao, Zhiyong

2016-07-01

Clinical research and animal experiment. To investigate whether lumbar disc degeneration is associated with Propionibacterium acnes (P acnes) infection. The hypothesis that herniated discs may be infected with P acnes by way of bacteremia is remarkable. This may bring a tremendous change in treatment of lumbar disc herniation (LDH). However, this hypothesis is still controversial. Since P acnes isolated may be related to contamination. Nucleus pulposus from 22 patients (30 discs) with lumbar disc herniation was collected during discectomy, following aerobic and anaerobic cultures for 10 days.Twenty-four rabbits were divided into four groups. After L3-L6 being exposed, an incision was made into the three discs in groups A and B. While in groups C and D, two random segments were operated. Six weeks later, 0.05 mL of 5 × 10 CFU/mL P acnes was inoculated into operated discs in group A and sterile physiological saline in group B. In group C, 0.2 mL of 5 × 10 CFU/mL P acnes was injected through ear vein. Sterile saline was used in group D. Six weeks later, MRI was performed. Then, nucleus pulposus and paraspinal muscles were harvested for aerobic and anaerobic cultures. Clinical research: Anaerobic cultures were positive in three cases: two coagulase-negative staphylococci, one particles chain bacterium. No P acnes was found. Staphylococcus epidermidis was isolated in one aerobic culture.Animal experiment: P acnes was found in 11 out of 18 (61%) discs in group A. There was no P acnes found in the other three groups. Degenerated discs were suitable for P acnes growth. This research did not find the evidence of the symptomatic degenerated lumbar discs infected with P acnes or that P acnes could infect the degenerated lumbar discs by way of bacteremia. N/A.

OARSI Clinical Trials Recommendations: Design and conduct of clinical trials of lifestyle diet and exercise interventions for osteoarthritis.

PubMed

Messier, S P; Callahan, L F; Golightly, Y M; Keefe, F J

2015-05-01

The objective was to develop a set of "best practices" for use as a primer for those interested in entering the clinical trials field for lifestyle diet and/or exercise interventions in osteoarthritis (OA), and as a set of recommendations for experienced clinical trials investigators. A subcommittee of the non-pharmacologic therapies committee of the OARSI Clinical Trials Working Group was selected by the Steering Committee to develop a set of recommended principles for non-pharmacologic diet/exercise OA randomized clinical trials. Topics were identified for inclusion by co-authors and reviewed by the subcommittee. Resources included authors' expert opinions, traditional search methods including MEDLINE (via PubMed), and previously published guidelines. Suggested steps and considerations for study methods (e.g., recruitment and enrollment of participants, study design, intervention and assessment methods) were recommended. The recommendations set forth in this paper provide a guide from which a research group can design a lifestyle diet/exercise randomized clinical trial in patients with OA. Copyright © 2015 Osteoarthritis Research Society International. Published by Elsevier Ltd. All rights reserved.

76 FR 51995 - National Center for Research Resources; Notice of Closed Meetings

Federal Register 2010, 2011, 2012, 2013, 2014

2011-08-19

... Review Group, Comparative Medicine Review Committee, Comparative Medicine Review Committee. Date: October... Domestic Assistance Program Nos. 93.306, Comparative Medicine; 93.333, Clinical Research; 93.371...

Development of a Research Participants’ Perception Survey to Improve Clinical Research

PubMed Central

Yessis, Jennifer L.; Kost, Rhonda G.; Lee, Laura M.; Coller, Barry S.; Henderson, David K.

2012-01-01

Abstract Introduction: Clinical research participants’ perceptions regarding their experiences during research protocols provide outcome‐based insights into the effectiveness of efforts to protect rights and safety, and opportunities to enhance participants’ clinical research experiences. Use of validated surveys measuring patient‐centered outcomes is standard in hospitals, yet no instruments exist to assess outcomes of clinical research processes. Methods: We derived survey questions from data obtained from focus groups comprised of research participants and professionals. We assessed the survey for face/content validity, and privacy/confidentiality protections and fielded it to research participants at 15 centers. We conducted analyses of response rates, sample characteristics, and psychometrics, including survey and item completion and analysis, internal consistency, item internal consistency, criterion‐related validity, and item usefulness. Responses were tested for fit into existing patient‐centered dimensions of care and new clinical research dimensions using Cronbach's alpha coefficient. Results: Surveys were mailed to 18,890 individuals; 4,961 were returned (29%). Survey completion was 89% overall; completion rates exceeded 90% for 88 of 93 evaluable items. Questions fit into three dimensions of patient‐centered care and two novel clinical research dimensions (Cronbach's alpha for dimensions: 0.69–0.85). Conclusions: The validated survey offers a new method for assessing and improving outcomes of clinical research processes. Clin Trans Sci 2012; Volume 5: 452–460 PMID:23253666

Assessing the impact of user-centered research on a clinical trial eHealth tool via counterbalanced research design

PubMed Central

Massett, Holly A; Mylks, Christy; McCormack, Lauren A; Kish-Doto, Julia; Hesse, Bradford W; Wang, Min Qi

2010-01-01

Objective 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. Design 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. Measurements 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. Results 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. Conclusion 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. PMID:21169619

Development of a consensus core dataset in juvenile dermatomyositis for clinical use to inform research

PubMed Central

McCann, Liza J; Pilkington, Clarissa A; Huber, Adam M; Ravelli, Angelo; Appelbe, Duncan; Kirkham, Jamie J; Williamson, Paula R; Aggarwal, Amita; Christopher-Stine, Lisa; Constantin, Tamas; Feldman, Brian M; Lundberg, Ingrid; Maillard, Sue; Mathiesen, Pernille; Murphy, Ruth; Pachman, Lauren M; Reed, Ann M; Rider, Lisa G; van Royen-Kerkof, Annet; Russo, Ricardo; Spinty, Stefan; Wedderburn, Lucy R

2018-01-01

Objectives This study aimed to develop consensus on an internationally agreed dataset for juvenile dermatomyositis (JDM), designed for clinical use, to enhance collaborative research and allow integration of data between centres. Methods A prototype dataset was developed through a formal process that included analysing items within existing databases of patients with idiopathic inflammatory myopathies. This template was used to aid a structured multistage consensus process. Exploiting Delphi methodology, two web-based questionnaires were distributed to healthcare professionals caring for patients with JDM identified through email distribution lists of international paediatric rheumatology and myositis research groups. A separate questionnaire was sent to parents of children with JDM and patients with JDM, identified through established research networks and patient support groups. The results of these parallel processes informed a face-to-face nominal group consensus meeting of international myositis experts, tasked with defining the content of the dataset. This developed dataset was tested in routine clinical practice before review and finalisation. Results A dataset containing 123 items was formulated with an accompanying glossary. Demographic and diagnostic data are contained within form A collected at baseline visit only, disease activity measures are included within form B collected at every visit and disease damage items within form C collected at baseline and annual visits thereafter. Conclusions Through a robust international process, a consensus dataset for JDM has been formulated that can capture disease activity and damage over time. This dataset can be incorporated into national and international collaborative efforts, including existing clinical research databases. PMID:29084729

Global Oral Health Inequalities

PubMed Central

Pitts, N.; Amaechi, B.; Niederman, R.; Acevedo, A.-M.; Vianna, R.; Ganss, C.; Ismail, A.; Honkala, E.

2011-01-01

The IADR Global Oral Health Inequalities Task Group on Dental Caries has synthesized current evidence and opinion to identify a five-year implementation and research agenda which should lead to improvements in global oral health, with particular reference to the implementation of current best evidence as well as integrated action to reduce caries and health inequalities between and within countries. The Group determined that research should: integrate health and oral health wherever possible, using common risk factors; be able to respond to and influence international developments in health, healthcare, and health payment systems as well as dental prevention and materials; and exploit the potential for novel funding partnerships with industry and foundations. More effective communication between and among the basic science, clinical science, and health promotion/public health research communities is needed. Translation of research into policy and practice should be a priority for all. Both community and individual interventions need tailoring to achieve a more equal and person-centered preventive focus and reduce any social gradient in health. Recommendations are made for both clinical and public health implementation of existing research and for caries-related research agendas in clinical science, health promotion/public health, and basic science. PMID:21490233

Effect of child health status on parents’ allowing children to participate in pediatric research

PubMed Central

2013-01-01

Background To identify motivational factors linked to child health status that affected the likelihood of parents’ allowing their child to participate in pediatric research. Methods Parents were invited to return their completed questionnaires anonymously to assess motivational factors and factors that might improve participation in pediatric research. Results Of 573 eligible parents, 261 returned the completed questionnaires. Of these, 126 were parents of healthy children (group 1), whereas 135 were parents of sick children who were divided into two groups according to the severity of their pathology, i.e., 99 ambulatory children (group 2) and 36 nonambulatory children (group 3). The main factor motivating participation in a pediatric clinical research study was “direct benefits for their child” (87.7%, 100%, and 100% for groups 1, 2, and 3, respectively). The other factors differed significantly between the three groups, depending on the child’s health status (all p < 0.05). Factors that might have a positive impact on parental consent to the participation of their child in a pediatric clinical research study differed significantly (χ2 test, all p ≤ 0.04), depending on the child’s health status. The main factor was “a better understanding of the study and its regulation” for the healthy children and ambulatory sick children groups (31.2% and 82.1%, respectively), whereas this was the third factor for the nonambulatory sick children group (50%). Conclusions Innovative strategies should be developed based on a child’s health status to improve information provision when seeking a child’s participation in pediatric research. Parents would like to spend more time in discussions with investigators. PMID:23414421

Proceedings of the Inaugural Pediatric Dermatology Research Alliance (PeDRA) Conference

PubMed Central

Siegel, Dawn H.; Choate, Keith; Drolet, Beth A.; Frieden, Ilona J.; Teng, Joyce M.; Tom, Wynnis; Williams, Mary; Eichenfield, Lawrence F.; Paller, Amy S.

2014-01-01

Abstract/Statement of the problem Skin disease research involving children currently faces several major hurdles and as a result, many therapies are only available for off-label use in children and many of the most pressing clinical needs of our pediatric population remain unsolved. A strategic planning committee of the Society for Pediatric Dermatology (SPD) identified the need for an organized, inclusive research alliance to augment the resources of individual practitioners and pre-existing smaller collaborative groups and facilitate robust, multicenter basic, translational, and clinical research and therapeutic trials. A December 2011 National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) Roundtable on Pediatric Dermatology further detailed the therapeutic gaps and barriers to translation of scientific advances to clinical practice. Building on these forums, in July 2012, a group of interested investigators met in Monterey, CA to develop the infrastructure for collaborative pediatric skin research, now called the Pediatric Dermatology Research Alliance (PeDRA). The vision of PeDRA is to create sustainable collaborative research networks to better understand, prevent, treat and cure dermatologic diseases in children. From that starting point, subcommittees and expert members were added, stakeholders identified, and seed funding garnered, with the first PeDRA stand-alone research meeting* realized in Chicago, IL in October 2013. PMID:25318428

Reaching beyond the review of research evidence: a qualitative study of decision making during the development of clinical practice guidelines for disease prevention in healthcare.

PubMed

Richter Sundberg, Linda; Garvare, Rickard; Nyström, Monica Elisabeth

2017-05-11

The judgment and decision making process during guideline development is central for producing high-quality clinical practice guidelines, but the topic is relatively underexplored in the guideline research literature. We have studied the development process of national guidelines with a disease-prevention scope produced by the National board of Health and Welfare (NBHW) in Sweden. The NBHW formal guideline development model states that guideline recommendations should be based on five decision-criteria: research evidence; curative/preventive effect size, severity of the condition; cost-effectiveness; and ethical considerations. A group of health profession representatives (i.e. a prioritization group) was assigned the task of ranking condition-intervention pairs for guideline recommendations, taking into consideration the multiple decision criteria. The aim of this study was to investigate the decision making process during the two-year development of national guidelines for methods of preventing disease. A qualitative inductive longitudinal case study approach was used to investigate the decision making process. Questionnaires, non-participant observations of nine two-day group meetings, and documents provided data for the analysis. Conventional and summative qualitative content analysis was used to analyse data. The guideline development model was modified ad-hoc as the group encountered three main types of dilemmas: high quality evidence vs. low adoptability of recommendation; insufficient evidence vs. high urgency to act; and incoherence in assessment and prioritization within and between four different lifestyle areas. The formal guideline development model guided the decision-criteria used, but three new or revised criteria were added by the group: 'clinical knowledge and experience', 'potential guideline consequences' and 'needs of vulnerable groups'. The frequency of the use of various criteria in discussions varied over time. Gender, professional status, and interpersonal skills were perceived to affect individuals' relative influence on group discussions. The study shows that guideline development groups make compromises between rigour and pragmatism. The formal guideline development model incorporated multiple aspects, but offered few details on how the different criteria should be handled. The guideline development model devoted little attention to the role of the decision-model and group-related factors. Guideline development models could benefit from clarifying the role of the group-related factors and non-research evidence, such as clinical experience and ethical considerations, in decision-processes during guideline development.

How Should Remote Clinical Monitoring Be Used to Treat Alcohol Use Disorders?: Initial Findings From an Expert Round Table Discussion.

PubMed

Gordon, Alan; Jaffe, Adi; McLellan, A Thomas; Richardson, Gary; Skipper, Gregory; Sucher, Michel; Tirado, Carlos F; Urschel, Harold C

Scientific evidence combined with new health insurance coverage now enable a chronic illness management approach to the treatment of alcohol use disorders (AUDs), including regular monitoring of blood alcohol content (BAC), as a useful indicator of disease control. Recent technical advances now permit many different types of remote, real-time monitoring of BAC. However, there is no body of research to empirically guide clinicians in how to maximize the clinical potential of remote BAC monitoring.As an initial step in guiding and supporting such research, the manufacturer of one remote BAC monitoring system sponsored a group of experienced clinicians and clinical researchers to discuss 8 issues that generally affect remote, clinical BAC monitoring of "adults in outpatient AUD treatment."The expert panel unanimously agreed that remote BAC monitoring for at least 12 months during and after the outpatient treatment of AUD was a clinically viable deterrent to relapse. There was also consensus that positive test results (ie, recent alcohol use) should lead to intensified care and monitoring. However, there was no agreement on specific types of clinical intensification after a positive test. The panel agreed that sharing positive and negative test results with members of the patient support group was helpful in reinforcing abstinence, yet they noted many practical issues regarding information sharing that remain concerning. Significant differences within the panel on several important clinical issues underline the need for more clinical and implementation research to produce empirically-supported guidelines for the use of remote BAC monitoring in AUD treatment.

How Should Remote Clinical Monitoring Be Used to Treat Alcohol Use Disorders?: Initial Findings From an Expert Round Table Discussion

PubMed Central

Gordon, Alan; Jaffe, Adi; McLellan, A. Thomas; Richardson, Gary; Skipper, Gregory; Sucher, Michel; Tirado, Carlos F.; Urschel, Harold C.

2017-01-01

Scientific evidence combined with new health insurance coverage now enable a chronic illness management approach to the treatment of alcohol use disorders (AUDs), including regular monitoring of blood alcohol content (BAC), as a useful indicator of disease control. Recent technical advances now permit many different types of remote, real-time monitoring of BAC. However, there is no body of research to empirically guide clinicians in how to maximize the clinical potential of remote BAC monitoring. As an initial step in guiding and supporting such research, the manufacturer of one remote BAC monitoring system sponsored a group of experienced clinicians and clinical researchers to discuss 8 issues that generally affect remote, clinical BAC monitoring of “adults in outpatient AUD treatment.” The expert panel unanimously agreed that remote BAC monitoring for at least 12 months during and after the outpatient treatment of AUD was a clinically viable deterrent to relapse. There was also consensus that positive test results (ie, recent alcohol use) should lead to intensified care and monitoring. However, there was no agreement on specific types of clinical intensification after a positive test. The panel agreed that sharing positive and negative test results with members of the patient support group was helpful in reinforcing abstinence, yet they noted many practical issues regarding information sharing that remain concerning. Significant differences within the panel on several important clinical issues underline the need for more clinical and implementation research to produce empirically-supported guidelines for the use of remote BAC monitoring in AUD treatment. PMID:28157829

Using Digital Technologies in Clinical HIV Research: Real-World Applications and Considerations for Future Work

PubMed Central

Bull, Sheana; Dietrich, Janan; Haberer, Jessica E; Van Der Pol, Barbara; Voronin, Yegor; Wall, Kristin M; Whalen, Christopher; Priddy, Frances

2017-01-01

Background Digital technologies, especially if used in novel ways, provide a number of potential advantages to clinical research in trials related to human immunodeficiency virus (HIV) and acquired immune deficiency syndrome (AIDS) and may greatly facilitate operations as well as data collection and analysis. These technologies may even allow answering questions that are not answerable with older technologies. However, they come with a variety of potential concerns for both the participants and the trial sponsors. The exact challenges and means for alleviation depend on the technology and on the population in which it is deployed, and the rapidly changing landscape of digital technologies presents a challenge for creating future-proof guidelines for technology application. Objective The aim of this study was to identify and summarize some common themes that are frequently encountered by researchers in this context and highlight those that should be carefully considered before making a decision to include these technologies in their research. Methods In April 2016, the Global HIV Vaccine Enterprise surveyed the field for research groups with recent experience in novel applications of digital technologies in HIV clinical research and convened these groups for a 1-day meeting. Real-world uses of various technologies were presented and discussed by 46 attendees, most of whom were researchers involved in the design and conduct of clinical trials of biomedical HIV prevention and treatment approaches. After the meeting, a small group of organizers reviewed the presentations and feedback obtained during the meeting and categorized various lessons-learned to identify common themes. A group of 9 experts developed a draft summary of the findings that was circulated via email to all 46 attendees for review. Taking into account the feedback received, the group finalized the considerations that are presented here. Results Meeting presenters and attendees discussed the many successful applications of digital technologies to improve research outcomes, such as those for recruitment and enrollment, participant identification, informed consent, data collection, data quality, and protocol or treatment adherence. These discussions also revealed unintended consequence of technology usage, including risks to study participants and risks to study integrity. Conclusions Key lessons learned from these discussions included the need to thoroughly evaluate systems to be used, the idea that early success may not be sustained throughout the study, that some failures will occur, and considerations for study-provided devices. Additionally, taking these key lessons into account, the group generated recommendations on how to move forward with the use of technology in HIV vaccine and biomedical prevention trials. PMID:28760729

Assays for Qualification and Quality Stratification of Clinical Biospecimens Used in Research: A Technical Report from the ISBER Biospecimen Science Working Group.

PubMed

Betsou, Fay; Bulla, Alexandre; Cho, Sang Yun; Clements, Judith; Chuaqui, Rodrigo; Coppola, Domenico; De Souza, Yvonne; De Wilde, Annemieke; Grizzle, William; Guadagni, Fiorella; Gunter, Elaine; Heil, Stacey; Hodgkinson, Verity; Kessler, Joseph; Kiehntopf, Michael; Kim, Hee Sung; Koppandi, Iren; Shea, Katheryn; Singh, Rajeev; Sobel, Marc; Somiari, Stella; Spyropoulos, Demetri; Stone, Mars; Tybring, Gunnel; Valyi-Nagy, Klara; Van den Eynden, Gert; Wadhwa, Lalita

2016-10-01

This technical report presents quality control (QC) assays that can be performed in order to qualify clinical biospecimens that have been biobanked for use in research. Some QC assays are specific to a disease area. Some QC assays are specific to a particular downstream analytical platform. When such a qualification is not possible, QC assays are presented that can be performed to stratify clinical biospecimens according to their biomolecular quality.

Assays for Qualification and Quality Stratification of Clinical Biospecimens Used in Research: A Technical Report from the ISBER Biospecimen Science Working Group

PubMed Central

Bulla, Alexandre; Cho, Sang Yun; Clements, Judith; Chuaqui, Rodrigo; Coppola, Domenico; De Souza, Yvonne; De Wilde, Annemieke; Grizzle, William; Guadagni, Fiorella; Gunter, Elaine; Heil, Stacey; Hodgkinson, Verity; Kessler, Joseph; Kiehntopf, Michael; Kim, Hee Sung; Koppandi, Iren; Shea, Katheryn; Singh, Rajeev; Sobel, Marc; Somiari, Stella; Spyropoulos, Demetri; Stone, Mars; Tybring, Gunnel; Valyi-Nagy, Klara; Van den Eynden, Gert; Wadhwa, Lalita

2016-01-01

This technical report presents quality control (QC) assays that can be performed in order to qualify clinical biospecimens that have been biobanked for use in research. Some QC assays are specific to a disease area. Some QC assays are specific to a particular downstream analytical platform. When such a qualification is not possible, QC assays are presented that can be performed to stratify clinical biospecimens according to their biomolecular quality. PMID:27046294

Control group design: enhancing rigor in research of mind-body therapies for depression.

PubMed

Kinser, Patricia Anne; Robins, Jo Lynne

2013-01-01

Although a growing body of research suggests that mind-body therapies may be appropriate to integrate into the treatment of depression, studies consistently lack methodological sophistication particularly in the area of control groups. In order to better understand the relationship between control group selection and methodological rigor, we provide a brief review of the literature on control group design in yoga and tai chi studies for depression, and we discuss challenges we have faced in the design of control groups for our recent clinical trials of these mind-body complementary therapies for women with depression. To address the multiple challenges of research about mind-body therapies, we suggest that researchers should consider 4 key questions: whether the study design matches the research question; whether the control group addresses performance, expectation, and detection bias; whether the control group is ethical, feasible, and attractive; and whether the control group is designed to adequately control for nonspecific intervention effects. Based on these questions, we provide specific recommendations about control group design with the goal of minimizing bias and maximizing validity in future research.

Control Group Design: Enhancing Rigor in Research of Mind-Body Therapies for Depression

PubMed Central

Kinser, Patricia Anne; Robins, Jo Lynne

2013-01-01

Although a growing body of research suggests that mind-body therapies may be appropriate to integrate into the treatment of depression, studies consistently lack methodological sophistication particularly in the area of control groups. In order to better understand the relationship between control group selection and methodological rigor, we provide a brief review of the literature on control group design in yoga and tai chi studies for depression, and we discuss challenges we have faced in the design of control groups for our recent clinical trials of these mind-body complementary therapies for women with depression. To address the multiple challenges of research about mind-body therapies, we suggest that researchers should consider 4 key questions: whether the study design matches the research question; whether the control group addresses performance, expectation, and detection bias; whether the control group is ethical, feasible, and attractive; and whether the control group is designed to adequately control for nonspecific intervention effects. Based on these questions, we provide specific recommendations about control group design with the goal of minimizing bias and maximizing validity in future research. PMID:23662111

The molecular biology of soft-tissue sarcomas and current trends in therapy.

PubMed

Quesada, Jorge; Amato, Robert

2012-01-01

Basic research in sarcoma models has been fundamental in the discovery of scientific milestones leading to a better understanding of the molecular biology of cancer. Yet, clinical research in sarcoma has lagged behind other cancers because of the multiple clinical and pathological entities that characterize sarcomas and their rarity. Sarcomas encompass a very heterogeneous group of tumors with diverse pathological and clinical overlapping characteristics. Molecular testing has been fundamental in the identification and better definition of more specific entities among this vast array of malignancies. A group of sarcomas are distinguished by specific molecular aberrations such as somatic mutations, intergene deletions, gene amplifications, reciprocal translocations, and complex karyotypes. These and other discoveries have led to a better understanding of the growth signals and the molecular pathways involved in the development of these tumors. These findings are leading to treatment strategies currently under intense investigation. Disruption of the growth signals is being targeted with antagonistic antibodies, tyrosine kinase inhibitors, and inhibitors of several downstream molecules in diverse molecular pathways. Preliminary clinical trials, supported by solid basic research and strong preclinical evidence, promises a new era in the clinical management of these broad spectrum of malignant tumors.

Development of research priorities in paediatric pain and palliative care

PubMed Central

Liossi, Christina; Anderson, Anna-Karenia; Howard, Richard F

2016-01-01

Priority setting for healthcare research is as important as conducting the research itself because rigorous and systematic processes of priority setting can make an important contribution to the quality of research. This project aimed to prioritise clinical therapeutic uncertainties in paediatric pain and palliative care in order to encourage and inform the future research agenda and raise the profile of paediatric pain and palliative care in the United Kingdom. Clinical therapeutic uncertainties were identified and transformed into patient, intervention, comparison and outcome (PICO) format and prioritised using a modified Nominal Group Technique. Members of the Clinical Studies Group in Pain and Palliative Care within National Institute for Health Research (NIHR) Clinical Research Network (CRN)-Children took part in the prioritisation exercise. There were 11 clinically active professionals spanning across a wide range of paediatric disciplines and one parent representative. The top three research priorities related to establishing the safety and efficacy of (1) gabapentin in the management of chronic pain with neuropathic characteristics, (2) intravenous non-steroidal anti-inflammatory drugs in the management of post-operative pain in pre-schoolers and (3) different opioid formulations in the management of acute pain in children while at home. Questions about the long-term effect of psychological interventions in the management of chronic pain and various pharmacological interventions to improve pain and symptom management in palliative care were among the ‘top 10’ priorities. The results of prioritisation were included in the UK Database of Uncertainties about the Effects of Treatments (DUETS) database. Increased awareness of priorities and priority-setting processes should encourage clinicians and other stakeholders to engage in such exercises in the future. PMID:28386399

Intra-individual variability in tinnitus patients : current thoughts and perspectives.

PubMed

Dauman, N; Erlandsson, S; Lundlin, L; Dauman, R

2015-04-01

Most tinnitus studies have attempted to compare groups of individuals, thus revealing inter-individuals differences, i.e., variations between compared subjects. For methodological reasons, inter-individual studies cannot take into account the variability of tinnitus experience, which has been known for decades to be relevant in daily practice with tinnitus patients. The concept of intra-individual variability has been promoted in the research literature, in order to shed light on this aspect of individual perception. In previous studies, unrelated to hearing, the concept of intra-individual variability implied inclusion of the environment (i.e., physical and social interactions) as a factor of individual performance. In tinnitus research, we believe that the concept of variability (within a person) could find a place beside the concept of variation (between groups of subjects). In this paper, four perspectives of tinnitus experiences from the clinical and research fields are described: (1) ENT consultation; (2) short-term group psychotherapy; (3) psychodynamic psychotherapy; and (4) clinical psychological research. Intra-individual variability stresses the importance of defining tinnitus in a dynamic way, contrary to the current definition of tinnitus as the perception of sound(s). In clinical practice, it is useful to embrace the perspective of the perceiver of tinnitus, and to include social and cultural circumstances as well as audiological/physical changes.

Engaging Patients in Setting a Patient-Centered Outcomes Research Agenda in Hematopoietic Cell Transplantation

PubMed Central

Burns, Linda J; Abbetti, Beatrice; Arnold, Stacie D; Bender, Jeffrey; Doughtie, Susan; El-Jawahiri, Areej; Gee, Gloria; Hahn, Theresa; Horowitz, Mary M; Johnson, Shirley; Juckett, Mark; Krishnamurit, Lakshmanan; Kullberg, Susan; LeMaistre, C. Fred; Loren, Alison; Majhail, Navneet S; Murphy, Elizabeth A; Rizzo, Doug; Roche-Green, Alva; Saber, Wael; Schatz, Barry A; Schmit-Pokorny, Kim; Shaw, Bronwen E; Syrjala, Karen L; Tierney, D. Kathryn; Ullrich, Christina; Vanness, David J; Wood, William A; Denzen, Ellen M

2018-01-01

The goal of patient-centered outcomes research (PCOR) is to help patients and those who care for them make informed decisions about healthcare. However, the clinical research enterprise has not involved patients, caregivers, and other non-providers routinely in the process of prioritizing, designing and conducting research in hematopoietic cell transplantation (HCT). To address this need, the National Marrow Donor Program (NMDP)/Be The Match® engaged patients, caregivers, researchers and other key stakeholders in a two-year project with the goal of setting a PCOR agenda for the HCT community. Through a collaborative process, we identified six major areas of interest: 1) Patient, Caregiver and Family Education and Support; 2) Emotional, Cognitive and Social Health; 3) Physical Health and Fatigue; 4) Sexual Health and Relationships; 5) Financial Burden; and 6) Models of Survivorship Care Delivery. We then organized into multi-stakeholder Working Groups to identify gaps in knowledge and make priority recommendations for critical research to fill those gaps. Gaps varied by Working Group, but all noted that a historical lack of consistency in measures utilized and patient populations made it difficult to compare outcomes across studies and urged investigators to incorporate uniform measures and homogenous patient groups in future research. Some groups advised that additional pre-emptory work is needed before conducting prospective interventional trials, whereas others felt ready to proceed with comparative clinical effectiveness research studies. This report presents the results of this major initiative, and makes recommendations by Working Group on priority questions for PCOR in HCT. PMID:29408289

Validation of consensus panel diagnosis in dementia.

PubMed

Gabel, Matthew J; Foster, Norman L; Heidebrink, Judith L; Higdon, Roger; Aizenstein, Howard J; Arnold, Steven E; Barbas, Nancy R; Boeve, Bradley F; Burke, James R; Clark, Christopher M; Dekosky, Steven T; Farlow, Martin R; Jagust, William J; Kawas, Claudia H; Koeppe, Robert A; Leverenz, James B; Lipton, Anne M; Peskind, Elaine R; Turner, R Scott; Womack, Kyle B; Zamrini, Edward Y

2010-12-01

The clinical diagnosis of dementing diseases largely depends on the subjective interpretation of patient symptoms. Consensus panels are frequently used in research to determine diagnoses when definitive pathologic findings are unavailable. Nevertheless, research on group decision making indicates that many factors can adversely affect panel performance. To determine conditions that improve consensus panel diagnosis. Comparison of neuropathologic diagnoses with individual and consensus panel diagnoses based on clinical scenarios only, fludeoxyglucose F 18 positron emission tomography images only, and scenarios plus images. Expert and trainee individual and consensus panel deliberations using a modified Delphi method in a pilot research study of the diagnostic utility of fludeoxyglucose F 18 positron emission tomography. Forty-five patients with pathologically confirmed Alzheimer disease or frontotemporal dementia. Statistical measures of diagnostic accuracy, agreement, and confidence for individual raters and panelists before and after consensus deliberations. The consensus protocol using trainees and experts surpassed the accuracy of individual expert diagnoses when clinical information elicited diverse judgments. In these situations, consensus was 3.5 times more likely to produce positive rather than negative changes in the accuracy and diagnostic certainty of individual panelists. A rule that forced group consensus was at least as accurate as majority and unanimity rules. Using a modified Delphi protocol to arrive at a consensus diagnosis is a reasonable substitute for pathologic information. This protocol improves diagnostic accuracy and certainty when panelist judgments differ and is easily adapted to other research and clinical settings while avoiding the potential pitfalls of group decision making.

Common Data Elements for Spinal Cord Injury Clinical Research: A National Institute for Neurological Disorders and Stroke Project

PubMed Central

Biering-Sørensen, Fin; Alai, Sherita; Anderson, Kim; Charlifue, Susan; Chen, Yuying; DeVivo, Michael; Flanders, Adam E.; Jones, Linda; Kleitman, Naomi; Lans, Aria; Noonan, Vanessa K.; Odenkirchen, Joanne; Steeves, John; Tansey, Keith; Widerström-Noga, Eva; Jakeman, Lyn B.

2015-01-01

Objective To develop a comprehensive set of common data elements (CDEs), data definitions, case report forms and guidelines for use in spinal cord injury (SCI) clinical research, as part of the CDE project at the National Institute of Neurological Disorders and Stroke (NINDS) of the USA National Institutes of Health. Setting International Working Groups Methods Nine working groups composed of international experts reviewed existing CDEs and instruments, created new elements when needed, and provided recommendations for SCI clinical research. The project was carried out in collaboration with and cross-referenced to development of the International Spinal Cord Society (ISCoS) International SCI Data Sets. The recommendations were compiled, subjected to internal review, and posted online for external public comment. The final version was reviewed by all working groups and the NINDS CDE team prior to release. Results The NINDS SCI CDEs and supporting documents are publically available on the NINDS CDE website and the ISCoS website. The CDEs span the continuum of SCI care and the full range of domains of the International Classification of Functioning, Disability and Health. Conclusions Widespread use of common data elements can facilitate SCI clinical research and trial design, data sharing, and retrospective analyses. Continued international collaboration will enable consistent data collection and reporting, and will help ensure that the data elements are updated, reviewed and broadcast as additional evidence is obtained. PMID:25665542

Clinical efficacy of a herbal dentifrice on dentinal hypersensitivity: a randomized controlled clinical trial.

PubMed

Kumari, M; Naik, S B; Rao, N S; Martande, S S; Pradeep, A R

2013-12-01

Dentinal hypersensitivity is a common problem and there is a growing interest in herbal based formulations for the treatment of oral diseases. This study was conducted to assess the efficacy of a commercially available novel herbal dentifrice in reduction of dentinal hypersensitivity. A total of 73 subjects (38 males and 35 females; aged 25-60 years) were randomly divided into two groups: Group 1 - a placebo dentifrice (The Himalaya Drug Company Research and Development, Makali, Bangalore) and Group 2 - (test group), a commercially available herbal dentifrice (Hi Ora K, The Himalaya Drug Company Research and Development, Makali, Bangalore). Sensitivity scores for controlled air stimulus and cold water were recorded at baseline, 6 weeks and 12 weeks. The test group was found to be significantly better compared to the placebo group at the end of 6 and 12 weeks in reduction of dentinal hypersensitivity. The novel herbal dentifrice can be recommended for treatment of dentinal hypersensitivity. © 2013 Australian Dental Association.

An official multi-society statement: the role of clinical research results in the practice of critical care medicine.

PubMed

Tonelli, Mark R; Curtis, J Randall; Guntupalli, Kalpalatha K; Rubenfeld, Gordon D; Arroliga, Alejandro C; Brochard, Laurent; Douglas, Ivor S; Gutterman, David D; Hall, Jesse R; Kavanagh, Brian P; Mancebo, Jordi; Misak, Cheryl J; Simpson, Steven Q; Slutsky, Arthur S; Suffredini, Anthony F; Thompson, B Taylor; Ware, Lorraine B; Wheeler, Arthur P; Levy, Mitchell M

2012-05-15

While the results of clinical research are clearly valuable in the care of critically ill patients, the limitations of such information and the role of other forms of medical knowledge for clinical decision making have not been carefully examined. The leadership of three large professional societies representing critical care practitioners convened a diverse group representing a wide variety of views regarding the role of clinical research results in clinical practice to develop a document to serve as a basis for agreement and a framework for ongoing discussion. Consensus was reached on several issues. While the results of rigorous clinical research are important in arriving at the best course of action for an individual critically ill patient, other forms of medical knowledge, including clinical experience and pathophysiologic reasoning, remain essential. No single source of knowledge is sufficient to guide clinical decisions, nor does one kind of knowledge always take precedence over others. Clinicians will find clinical research compelling for a variety of reasons that go beyond study design. While clinical practice guidelines and protocols based upon clinical research may improve care and decrease variability in practice, clinicians must be able to understand and articulate the rationale as to why a particular protocol or guideline is used or why an alternative approach is taken. Making this clinical reasoning explicit is necessary to understand practice variability. Understanding the strengths and weaknesses of different kinds of medical knowledge for clinical decision making and factors beyond study design that make clinical research compelling to clinicians can provide a framework for understanding the role of clinical research in practice.

Myositis registries and biorepositories: powerful tools to advance clinical, epidemiologic and pathogenic research

PubMed Central

Rider, Lisa G.; Dankó, Katalin; Miller, Frederick W.

2016-01-01

Purpose of review Clinical registries and biorepositories have proven extremely useful in many studies of diseases, especially rare diseases. Given their rarity and diversity, the idiopathic inflammatory myopathies, or myositis syndromes, have benefited from individual researchers’ collections of cohorts of patients. Major efforts are being made to establish large registries and biorepositories that will allow many additional studies to be performed that were not possible before. Here we describe the registries developed by investigators and patient support groups that are currently available for collaborative research purposes. Recent findings We have identified 46 myositis research registries, including many with biorepositories, which have been developed for a wide variety of purposes and have resulted in great advances in understanding the range of phenotypes, clinical presentations, risk factors, pathogenic mechanisms, outcome assessment, therapeutic responses, and prognoses. These are now available for collaborative use to undertake additional studies. Two myositis patient registries have been developed for research, and myositis patient support groups maintain demographic registries with large numbers of patients available to be contacted for potential research participation. Summary Investigator-initiated myositis research registries and biorepositories have proven extremely useful in understanding many aspects of these rare and diverse autoimmune diseases. These registries and biorepositories, in addition to those developed by myositis patient support groups, deserve continued support to maintain the momentum in this field as they offer major opportunities to improve understanding of the pathogenesis and treatment of these diseases in cost-effective ways. PMID:25225838

Evaluating clinical librarian services: a systematic review.

PubMed

Brettle, Alison; Maden-Jenkins, Michelle; Anderson, Lucy; McNally, Rosalind; Pratchett, Tracey; Tancock, Jenny; Thornton, Debra; Webb, Anne

2011-03-01

  Previous systematic reviews have indicated limited evidence and poor quality evaluations of clinical librarian (CL) services. Rigorous evaluations should demonstrate the value of CL services, but guidance is needed before this can be achieved.   To undertake a systematic review which examines models of CL services, quality, methods and perspectives of clinical librarian service evaluations.   Systematic review methodology and synthesis of evidence, undertaken collaboratively by a group of 8 librarians to develop research and critical appraisal skills.   There are four clear models of clinical library service provision. Clinical librarians are effective in saving health professionals time, providing relevant, useful information and high quality services. Clinical librarians have a positive effect on clinical decision making by contributing to better informed decisions, diagnosis and choice of drug or therapy. The quality of CL studies is improving, but more work is needed on reducing bias and providing evidence of specific impacts on patient care. The Critical Incident Technique as part of a mixed method approach appears to offer a useful approach to demonstrating impact.   This systematic review provides practical guidance regarding the evaluation of CL services. It also provides updated evidence regarding the effectiveness and impact of CL services. The approach used was successful in developing research and critical appraisal skills in a group of librarians. © 2010 The authors. Health Information and Libraries Journal © 2010 Health Libraries Group.

[Development and effects of emotional intelligence program for undergraduate nursing students: mixed methods research].

PubMed

Lee, Oi Sun; Gu, Mee Ock

2014-12-01

This study was conducted to develop and test the effects of an emotional intelligence program for undergraduate nursing students. The study design was a mixed method research. Participants were 36 nursing students (intervention group: 17, control group: 19). The emotional intelligence program was provided for 4 weeks (8 sessions, 20 hours). Data were collected between August 6 and October 4, 2013. Quantitative data were analyzed using Chi-square, Fisher's exact test, t-test, repeated measure ANOVA, and paired t-test with SPSS/WIN 18.0. Qualitative data were analyzed using content analysis. Quantitative results showed that emotional intelligence, communication skills, resilience, stress coping strategy, and clinical competence were significantly better in the experimental group compared to the control group. According to the qualitative results, the nursing students experienced improvement in emotional intelligence, interpersonal relationships, and empowerment, as well as a reduction in clinical practice stress after participation in the emotional intelligence program. Study findings indicate that the emotional intelligence program for undergraduate nursing students is effective and can be recommended as an intervention for improving the clinical competence of undergraduate students in a nursing curriculum.

[Clinical research outside of teaching hospitals: Current situation in north-eastern France].

PubMed

Goetz, C; Dupoux, A; Déloy, L; Hertz, C; Jeanmaire, T; Parneix, N

2015-04-01

Most clinical research in France takes place in teaching hospitals. There are, however, many advantages to developing it in other hospitals: access to innovative treatments, improvement in healthcare quality, attractiveness of hospitals, increased trial inclusion rates and reduced selection bias. The objectives of our study were to report on the current situation of clinical research outside teaching hospitals. A three-stage survey was conducted between January 2012 and May 2013 in non-teaching hospitals of north-eastern France. First, questionnaires were sent to administrative and medical boards of all hospitals with more than 100 beds, then to head doctors of every department in hospitals with more than 300 beds and finally meetings were organized with members of 20 selected hospitals. The administrative and medical boards of 85 hospitals participated in the first stage of the survey; half of these hospitals were engaged in clinical research activities and for 10 the internal structuring was cross-disciplinary. Answers from 178 departments were obtained during the second stage; 47% reported a clinical research activity. Meetings with research teams in 20 hospitals allowed us to identify difficulties concerning research funding, transversal organization and sponsoring. Clinical research existed in more than half of the respondent non-teaching hospitals. Obstacles to its development can be grouped in three categories: 1) internal structuring of clinical research, 2) access to information and knowledge of how clinical research functions and to interlocutors outside the hospital and 3) access to skills necessary to sponsor clinical research. Copyright © 2015 Elsevier Masson SAS. All rights reserved.

Frequently Asked Questions about Clinical Research

MedlinePlus

... given an experimental drug or treatment, while a control group is given either a standard treatment for the ... being tested, or whether they are in the control group. The goal is to prevent the so-called " ...

Gatekeepers for Pragmatic Clinical Trials

PubMed Central

Whicher, Danielle M.; Miller, Jennifer E.; Dunham, Kelly M.; Joffe, Steven

2015-01-01

To successfully implement a pragmatic clinical trial, investigators need access to numerous resources, including financial support, institutional infrastructure (e.g., clinics, facilities, staff), eligible patients, and patient data. Gatekeepers are people or entities who have the ability to allow or deny access to the resources required to support the conduct of clinical research. Based on this definition, gatekeepers relevant to the United States clinical research enterprise include research sponsors, regulatory agencies, payers, health system and other organizational leadership, research team leadership, human research protections programs, advocacy and community groups, and clinicians. This manuscript provides a framework to help guide gatekeepers’ decision-making related to the use of resources for pragmatic clinical trials. These include (1) concern for the interests of individuals, groups, and communities affected by the gatekeepers’ decisions, including protection from harm and maximization of benefits, (2) advancement of organizational mission and values, and (3) stewardship of financial, human, and other organizational resources. Separate from these ethical considerations, gatekeepers’ actions will be guided by relevant federal, state, and local regulations. This framework also suggests that to further enhance the legitimacy of their decision-making, gatekeepers should adopt transparent processes that engage relevant stakeholders when feasible and appropriate. We apply this framework to the set of gatekeepers responsible for making decisions about resources necessary for pragmatic clinical trials in the United States, describing the relevance of the criteria in different situations and pointing out where conflicts among the criteria and relevant regulations may affect decision-making. Recognition of the complex set of considerations that should inform decision-making will guide gatekeepers in making justifiable choices regarding the use of limited and valuable resources. PMID:26374683

A metadata schema for data objects in clinical research.

PubMed

Canham, Steve; Ohmann, Christian

2016-11-24

A large number of stakeholders have accepted the need for greater transparency in clinical research and, in the context of various initiatives and systems, have developed a diverse and expanding number of repositories for storing the data and documents created by clinical studies (collectively known as data objects). To make the best use of such resources, we assert that it is also necessary for stakeholders to agree and deploy a simple, consistent metadata scheme. The relevant data objects and their likely storage are described, and the requirements for metadata to support data sharing in clinical research are identified. Issues concerning persistent identifiers, for both studies and data objects, are explored. A scheme is proposed that is based on the DataCite standard, with extensions to cover the needs of clinical researchers, specifically to provide (a) study identification data, including links to clinical trial registries; (b) data object characteristics and identifiers; and (c) data covering location, ownership and access to the data object. The components of the metadata scheme are described. The metadata schema is proposed as a natural extension of a widely agreed standard to fill a gap not tackled by other standards related to clinical research (e.g., Clinical Data Interchange Standards Consortium, Biomedical Research Integrated Domain Group). The proposal could be integrated with, but is not dependent on, other moves to better structure data in clinical research.

E-survey with researchers, members of ethics committees and sponsors of clinical research in Brazil: an emerging methodology for scientific research.

PubMed

Dainesi, Sonia Mansoldo; Goldbaum, Moisés

2012-12-01

The growth of Internet users enables epidemiological studies to be conducted electronically, representing a promising methodology for data collection. Members of Ethics Committees, Clinical Researchers and Sponsors were interviewed using questionnaires sent over the Internet. Along with the questionnaire, participants received a message explaining the survey and also the informed consent. Returning the questionnaire meant the consent of the participant was given. No incentive was offered; two reminders were sent. The response rate was 21% (124/599), 20% (58/290) and 45% (24/53) respectively for Ethics Committees, Researchers and Sponsors. The percentage of return before the two reminders was about 62%. Reasons for non-response: participant not found, refusal to participate, lack of experience in clinical research or in the therapeutic field. Characteristics of participants: 45% of Ethics Committee participants, 64% of Researchers and 63% of Sponsors were male; mean age (range), respectively: 47 (28-74), 53 (24-72) and 40 (29-65) years. Among Researchers and Sponsors, all respondents had at least a university degree and, in the Ethics Committees group, only two (1.7%) did not have one. Most of the questionnaires in all groups came from the Southeast Region of Brazil, probably reflecting the highest number of clinical trials and research professionals in this region. Despite the potential limitations of a survey done through the Internet, this study led to a response rate similar to what has been observed with other models, efficiency in obtaining responses (speed and quality), convenience for respondents and low cost.

The Clinical Research Associate Retention Study: A Report From the Children's Oncology Group.

PubMed

Owens Pickle, Emily E; Borgerson, Dawn; Espirito-Santo, Anelise; Wigginton, Sabrina; Devine, Susan; Stork, Sue

Pediatric medicine often struggles to receive adequate research funding for its small, yet vulnerable population of patients. Remarkable discovery in pediatric oncology is credited in large part to the collaborative structure of its research community. The Children's Oncology Group conducts studies supported by the National Cancer Institute. The clinical research associate (CRA) discipline comprises professionals who support administrative duties, regulatory duties, subject management, and data collection at individual research sites. The purpose of this study was to identify factors associated with CRA retention, as the group continues to have high turnover and position vacancy. A cross-sectional survey design was used to characterize the most frequently cited reasons CRAs gave when considering leaving or staying within their position. Results suggest that low salary, unmanageable workload, lack of career advancement and professional development, and lack of research commitment from the medical team were associated with intent to leave CRA positions. The most frequently cited reasons for staying at their job were the meaningfulness and interest in the work, a supportive principal investigator, and enjoyment working with colleagues. CRAs reported serious but eminently solvable issues that can be addressed using practical and low-cost solutions to improve job satisfaction and retention.

Using research evidence in mental health: user-rating and focus group study of clinicians' preferences for a new clinical question-answering service.

PubMed

Barley, Elizabeth A; Murray, Joanna; Churchill, Rachel

2009-12-01

Clinicians report difficulties using research in their practices. The aim of the study was to describe needs and preferences for a mental health clinical question-answering service designed to assist this process. Multi-disciplinary clinicians participated in a focus group; users of the service supplied feedback. Fifty-four clinicians received answers to 84 questions about mental health treatments. User ratings showed that the answers had multiple uses: informing health care (43), education (22), staff development (28) and research (12), and were considered useful, clear, relevant and helpful. Focus group participants appreciated critically appraised summaries of evidence and stressed the time-saving benefit of the service. Clinicians without a medical training were least confident in applying evidence. Attitudes to research were positive, but concern was expressed about its potential misuse for political purposes. This appeared to arise from an ambiguity around the term 'insufficient evidence', which participants felt is widely misinterpreted as 'evidence of no effect'. A highly valued, responsive service has been developed. A range of clinicians find critically appraised summaries of research useful. Education about the use of research may help clinicians to be more evidence based.

Use of a problem-based learning discussion format to teach anesthesiology residents research fundamentals☆,☆☆,★

PubMed Central

Sakai, Tetsuro; Karausky, Patricia L.; Valenti, Shannon L.; Sandusky, Susan L.; Hirsch, Sandra C.; Xu, Yan

2013-01-01

Study Objective To present a new research problem-based learning discussion (PBLD) conference and to evaluate its effect on residents. Design Retrospective observational study of resident education before and after implementation of a research PBLD. Setting Large U.S. academic anesthesiology department. Subjects 93 anesthesiology residents with research PBLD exposure in the academic year (AY) 2010 and AY 2011, and 85 residents without research PBLD exposure in AY 2008 and AY 2009. Measurements Since AY 2010, a PBLD format has been used to teach residents clinical research fundamentals. The annual 90-minute PBLD addressed residents’ perceived barriers to research and introduced research resources available via the Clinical and Translational Science Institute (CTSI). Data recorded were: 1) number of residents who made CTSI consultation solicitations as a new investigator, and 2) number of new research projects proposed by the residents and designed with CTSI consultation. Each outcome was compared between the prePBLD group (AY 2008 [n=43] and AY 2009 [n=42]) and the postPBLD group (AY 2010 [n=43] and AY 2011 [n=50]). Main Results The number of residents who consulted the CTSI as new investigators increased from 4 of 85 residents (4.7%) in the prePBLD group to 13 of 93 residents (14.0%) in the postPBLD group (P = 0.042). The number of new research projects for which the residents consulted CTSI increased from 10 to 20 (100% increase). Conclusion A PBLD format for research education of anesthesiology residents is effective. PMID:23965212

Randomized and controlled clinical study of modified prescriptions of Simiao Pill in the treatment of acute gouty arthritis.

PubMed

Shi, Xin-de; Li, Guo-chun; Qian, Zu-xi; Jin, Ze-qiu; Song, Yan

2008-03-01

To investigate the compatibility of a modified prescription of Simiao Pill in the treatment of acute gouty arthritis and to verify the clinical efficacy and safety of the drug through a clinical trial. A randomized and controlled clinical trial was designed based on clinical epidemiological principles. A total of 107 patients with acute gouty arthritis were enrolled and randomly assigned to four groups. The first group (Group I) included 27 patients taking gout prescription I; the second group (Group II) included 27 patients taking gout prescription II; the third group (Group III) included 28 patients taking gout prescription III; and the fourth group (control group) included 25 patients taking indomethacin and Benzobromarone as a control group. The duration of the treatment in all 4 groups was two weeks. After the treatment, the index of blood uric acid, blood leukocyte count, score of clinical symptoms, etc. were observed and measured. The total clinical effective rate of the three different modified prescriptions of the Simiao Pill was above 96%, significantly superior to that of the control group (68%, P<0.05). In terms of the improvement of main symptoms, the scores of four symptoms in all TCM treatment and control groups decreased after treatment, with statistically significant differences (P<0.05). Moreover, the scores markedly fell more so in the three Chinese herb groups than in the control group, and especially in Group III (P<0.05). There was a statistically significant difference in blood uric acid values before and after the treatment in the same group but no significant inter-group difference was seen. The modified prescriptions, based on the clinical research, clinical experience and traditional Chinese medicine theory, did show a better effect than Western medicine in this clinical study. Moreover, the prescriptions were precise, with the herbs inexpensive and readily available. The patients had good compliance with less adverse reactions noted. The modified prescription has a favorable prospect for future development and is worthy of further blind trials with larger samples.

Careless and Random Responding on Clinical and Research Measures in the Addictions: A Concerning Problem and Investigation of Their Detection

ERIC Educational Resources Information Center

Meyer, Joseph F.; Faust, Kyle A.; Faust, David; Baker, Aaron M.; Cook, Nathan E.

2013-01-01

Even when relatively infrequent, careless and random responding (C/RR) can have robust effects on individual and group data and thereby distort clinical evaluations and research outcomes. Given such potential adverse impacts and the broad use of self-report measures when appraising addictions and addictive behavior, the detection of C/RR can…

From a Viewpoint of Clinical Settings: Pharmacoepidemiology as Reverse Translational Research (rTR).

PubMed

Kawakami, Junichi

2017-01-01

Clinical pharmacology and pharmacoepidemiology research may converge in practise. Pharmacoepidemiology is the study of pharmacotherapy and risk management in patient groups. For many drugs, adverse reaction(s) that were not seen and/or clarified during research and development stages have been reported in the real world. Pharmacoepidemiology can detect and verify adverse drug reactions as reverse translational research. Recently, development and effective use of medical information databases (MID) have been conducted in Japan and elsewhere for the purpose of post-marketing safety of drugs. The Ministry of Health, Labour and Welfare, Japan has been promoting the development of 10-million scale database in 10 hospitals and hospital groups as "the infrastructure project of medical information database (MID-NET)". This project enables estimation of the frequency of adverse reactions, the distinction between drug-induced reactions and basal health-condition changes, and usefulness verification of administrative measures of drug safety. However, because the database information is different from detailed medical records, construction of methodologies for the detection and evaluation of adverse reactions is required. We have been performing database research using medical information system in some hospitals to establish and demonstrate useful methods for post-marketing safety. In this symposium, we aim to discuss the possibility of reverse translational research from clinical settings and provide an introduction to our research.

[Recognition of international ethics codes by physicians and biomedical investigators. Are we prepared for the 21st century challenges?].

PubMed

Ponce-de-León, Sergio

2004-01-01

International oaths and declarations (IOD) represent the essence of proposals or promises on a relevant global issue for which a social group stands for. Their appropriate spread is essential in order for them to have a significant impact. The purpose of this study was to determine the frequency of recognition of several medical practice and clinical research related IOD, among medical personnel differentiated by level of clinical experience and closeness to biomedical research. Five groups were surveyed: 35 undergraduate interns, 50 internal medicine residents, 19 graduate (masters and doctoral degrees) students at the outset of courses, 18 veteran graduate students and 70 biomedical investigators. Performance in the recognition of the 6 probed IOD was uniformly poor. Barely just an average of about one declaration per subject was adequately identified. The Declaration of Helsinki was recognized by more than 50% of those belonging to the groups in which theory and practice of medical research joined together. No other IOD was recognized beyond a 40% level in any group. Comparison of university of origin showed no substantial differences. The lack of knowledge of IOD as a framework in the analysis of ethical conflicts arising along medical practice or clinical research is a worrisome issue. Medical schools seem to neglect their role in divulging them. Institutional review boards should also contribute to divulge IOD. The optimal incorporation of the IOD message comes from its acquisition through a process that links theory and practice.

Effects of disclosing financial interests on attitudes toward clinical research.

PubMed

Weinfurt, Kevin P; Hall, Mark A; Dinan, Michaela A; DePuy, Venita; Friedman, Joëlle Y; Allsbrook, Jennifer S; Sugarman, Jeremy

2008-06-01

The effects of disclosing financial interests to potential research participants are not well understood. To examine the effects of financial interest disclosures on potential research participants' attitudes toward clinical research. Computerized experiment conducted with 3,623 adults in the United States with either diabetes mellitus or asthma, grouped by lesser and greater severity. Respondents read a description of a hypothetical clinical trial relevant to their diagnosis that included a financial disclosure statement. Respondents received 1 of 5 disclosure statements. Willingness to participate in the hypothetical clinical trial, relative importance of information about the financial interest, change in trust after reading the disclosure statement, surprise regarding the financial interest, and perceived effect of the financial interest on the quality of the clinical trial. Willingness to participate in the hypothetical clinical trial did not differ substantially among the types of financial disclosures. Respondents viewed the disclosed information as less important than other factors in deciding to participate. Disclosures were associated with some respondents trusting the researchers less, although trust among some respondents increased. Most respondents were not surprised to learn of financial interests. Researchers owning equity were viewed as more troubling than researchers who were compensated for the costs of research through per capita payments. Aside from a researcher holding an equity interest, the disclosure to potential research participants of financial interests in research, as recommended in recent policies, is unlikely to affect willingness to participate in research.

Reflective practice groups for nurses: a consultation liaison psychiatry nursing initiative: part 2--the evaluation.

PubMed

Dawber, Chris

2013-06-01

This paper outlines an evaluation of reflective practice groups (RPG) involving nurses and midwives from three clinical nursing specialties at Redcliffe and Caboolture Hospitals, Queensland, Australia. The groups were facilitated by the consultation liaison psychiatry nurse and author using a process-focused, whole-of-group approach to explore clinical narrative in a supportive group setting. This was a preliminary evaluation utilizing a recently-developed tool, the Clinical Supervision Evaluation Questionnaire, along with externally-facilitated focus groups. Nurses and midwives responded favourably to RPG, reporting a positive impact on clinical practice, self-awareness, and resilience. The majority of participants considered RPG had positive implications for team functioning. The focus groups identified the importance of facilitation style and the need to address aspects of workplace culture to enable group development and enhance the capacity for reflection. Evaluation of the data indicates this style of RPG can improve reflective thinking, promote team cohesion, and provide support for nurses and midwives working in clinical settings. Following on from this study, a second phase of research has commenced, providing more detailed, longitudinal evaluation across a larger, more diverse group of nurses. © 2012 The Author; International Journal of Mental Health Nursing © 2012 Australian College of Mental Health Nurses Inc.

Data-Gathering, Belief Flexibility, and Reasoning Across the Psychosis Continuum

PubMed Central

Peters, Emmanuelle; Jackson, Mike; Day, Fern; Garety, Philippa A

2018-01-01

Abstract Background There is evidence for a group of nonclinical individuals with full-blown, persistent psychotic experiences (PEs) but no need-for-care: they are of particular importance in identifying risk and protective factors for clinical psychosis. The aim of this study was to investigate whether reasoning biases are related to PEs or need-for-care. Method Two groups with persistent PEs (clinical; n = 74; nonclinical; n = 92) and a control group without PEs (n = 83) were compared on jumping-to-conclusions (JTC) and belief flexibility. A randomly selected subset of interviews (n = 104) was analyzed to examine differences in experiential and rational reasoning. Results As predicted JTC was more common in the clinical than the other 2 groups. Unexpectedly no group differences were observed between clinical and nonclinical groups on measures of belief flexibility. However, the clinical group was less likely to employ rational reasoning, while the nonclinical group was more likely to use experiential reasoning plus a combination of both types of reasoning processes, compared to the other 2 groups. Conclusions Reasoning biases differ in groups with PEs with and without need-for-care. JTC is associated with need-for-care rather than with PEs. The ability to invoke rational reasoning processes, together with an absence of JTC, may protect against pathological outcomes of persistent PEs. However, marked use of experiential reasoning is associated with the occurrence of PEs in both clinical and nonclinical groups. Implications for theory development, intervention and further research are discussed. PMID:28338872

Clinical iron deficiency disturbs normal human responses to hypoxia

PubMed Central

Frise, Matthew C.; Cheng, Hung-Yuan; Nickol, Annabel H.; Curtis, M. Kate; Pollard, Karen A.; Roberts, David J.; Ratcliffe, Peter J.; Dorrington, Keith L.; Robbins, Peter A.

2016-01-01

BACKGROUND. Iron bioavailability has been identified as a factor that influences cellular hypoxia sensing, putatively via an action on the hypoxia-inducible factor (HIF) pathway. We therefore hypothesized that clinical iron deficiency would disturb integrated human responses to hypoxia. METHODS. We performed a prospective, controlled, observational study of the effects of iron status on hypoxic pulmonary hypertension. Individuals with absolute iron deficiency (ID) and an iron-replete (IR) control group were exposed to two 6-hour periods of isocapnic hypoxia. The second hypoxic exposure was preceded by i.v. infusion of iron. Pulmonary artery systolic pressure (PASP) was serially assessed with Doppler echocardiography. RESULTS. Thirteen ID individuals completed the study and were age- and sex-matched with controls. PASP did not differ by group or study day before each hypoxic exposure. During the first 6-hour hypoxic exposure, the rise in PASP was 6.2 mmHg greater in the ID group (absolute rises 16.1 and 10.7 mmHg, respectively; 95% CI for difference, 2.7–9.7 mmHg, P = 0.001). Intravenous iron attenuated the PASP rise in both groups; however, the effect was greater in ID participants than in controls (absolute reductions 11.1 and 6.8 mmHg, respectively; 95% CI for difference in change, –8.3 to –0.3 mmHg, P = 0.035). Serum erythropoietin responses to hypoxia also differed between groups. CONCLUSION. Clinical iron deficiency disturbs normal responses to hypoxia, as evidenced by exaggerated hypoxic pulmonary hypertension that is reversed by subsequent iron administration. Disturbed hypoxia sensing and signaling provides a mechanism through which iron deficiency may be detrimental to human health. TRIAL REGISTRATION. ClinicalTrials.gov (NCT01847352). FUNDING. M.C. Frise is the recipient of a British Heart Foundation Clinical Research Training Fellowship (FS/14/48/30828). K.L. Dorrington is supported by the Dunhill Medical Trust (R178/1110). D.J. Roberts was supported by R&D funding from National Health Service (NHS) Blood and Transplant and a National Institute for Health Research (NIHR) Programme grant (RP-PG-0310-1004). This research was funded by the NIHR Oxford Biomedical Research Centre Programme. PMID:27140401

As the medical education curriculum is changing, it is still good to train students and physicians in many different patient locations.

PubMed

Reynolds, Herbert Y

2014-12-01

Medical teaching methods are changing with students now encouraged to be self-learners, accruing more knowledge themselves, receiving less didactic instruction, utilizing more peer group interactions, and using more portable self-accessible technology to get medical information. Medical school curriculums are adapting with more simulated instruction, group analysis of clinical problems (problem-based learning), earlier exposure to patients and their evaluation, volunteer medical missions, and participation in relevant clinical research. But will these changes, especially the use of portable technology for retrieving medical information, enhance learning, and improve devising clinical strategy? To build clinical skills and confidence, it still seems relevant for the students and clinicians to evaluate patients in multiple locations under various circumstances. This is perhaps necessary during all phases of medical study, post-graduate training, research investigation, and in a medical career, including later phases when senior and elder faculty participate in medical teaching and/or provide health care. The emphasis of this perspective is to assess some of these clinical "settings" that reinforce learning skills and flexible clinical approaches.

Sex, pain and cranberries - ideas from the 2006 Registrar Research Workshop.

PubMed

Montgomery, Brett D; McMeniman, Erin; Cameron, Sara Kate; Duncan, Tristram; Prosser, Stuart; Moore, Ray

2007-01-01

The Registrar Research Workshop has been a feature of Australian general practice training since 1994. Twenty five general practice registrars attend the annual 3 day event, which aims to develop registrars' understanding of the research process. Presenters and facilitators are drawn from the academic general practitioner and primary health care research community. Presentations alternate with small group sessions, where groups of five registrars are guided through the process of developing a research question, identifying appropriate research methods, and addressing ethical and funding concerns, before preparing a presentation about their research proposal for their peers. Research questions are developed from unanswered questions that have arisen in registrars' clinical practice.

77 FR 31625 - Center For Scientific Review; Notice of Closed Meetings

Federal Register 2010, 2011, 2012, 2013, 2014

2012-05-29

... Integrated Review Group, Biostatistical Methods and Research Design Study Section. Date: June 22, 2012. Time... Domestic Assistance Program Nos. 93.306, Comparative Medicine; 93.333, Clinical Research, 93.306, 93.333...

78 FR 25753 - National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2013-05-02

... Infectious Diseases Special Emphasis Panel; Leadership Group for a HIV Vaccines Clinical Network. Date: May... Research; 93.856, Microbiology and Infectious Diseases Research, National Institutes of Health, HHS) Dated...

School-age outcomes of infants at risk for autism spectrum disorder.

PubMed

Miller, Meghan; Iosif, Ana-Maria; Young, Gregory S; Hill, Monique; Phelps Hanzel, Elise; Hutman, Ted; Johnson, Scott; Ozonoff, Sally

2016-06-01

Studies of infants at risk for autism spectrum disorder (ASD) have proliferated, but few of these samples have been followed longer-term. We conducted a follow-up study, at age 5.5-9 years, of younger siblings of children with ASD (high-risk group, n = 79) or typical development (low-risk group, n = 60), originally recruited as infants. Children with ASD were excluded because of the focus on understanding the range of non-ASD outcomes among high-risk siblings. Using examiner ratings, parent ratings, and standardized assessments, we evaluated differences in clinical outcomes, psychopathology symptoms, autism symptoms, language skills, and nonverbal cognitive abilities. After adjusting for covariates, the high-risk group had increased odds of any clinically elevated/impaired score across measures relative to the low-risk group (43% vs. 12%, respectively). The high-risk group also had increased odds of examiner-rated Clinical Concerns (CC) outcomes (e.g., ADHD concerns, broader autism phenotype, speech-language difficulties, anxiety/mood problems, learning problems) relative to the low-risk group (38% vs. 13%, respectively). The high-risk group with CC outcomes had higher parent-reported psychopathology and autism symptoms, and lower directly-assessed language skills, than the Low-Risk Typically Developing (TD) and High-Risk TD groups, which did not differ. There were no differences in nonverbal cognitive skills. For some in the high-risk group, clinical concerns persisted from early childhood, whereas for others clinical concerns were first evident at school-age. Results suggest continued vulnerability in at least a subgroup of school-age children with a family history of ASD and suggest that this population may benefit from continued screening and monitoring into the school-age years. Autism Res 2016, 9: 632-642. © 2015 International Society for Autism Research, Wiley Periodicals, Inc. © 2015 International Society for Autism Research, Wiley Periodicals, Inc.

Comparing the perceptions of academics and members of the public about patient and public involvement in ageing research.

PubMed

Tullo, Ellen StClair; Robinson, Lisa; Newton, Julia

2015-05-01

public and patient involvement (PPI) in clinical research is increasingly advocated by funding and regulatory bodies. However, little is known about the views of either academics or members of the public about perceptions of the practical realities of PPI, particularly in relation to ageing research. to survey current levels of PPI in biomedical and clinical research relating to ageing at one institution. To compare and contrast the views of academics and the public about PPI relating to research about ageing. electronic survey of senior academics, postgraduate students and members of a local user group for older people. thirty-three academics (18 principal investigators and 15 PhD students) at a biomedical research institution. Fifty-four members of a local user group for older people. thirty per cent (10/33) of projects described some PPI activity. Older adults were more positive about active involvement in research about ageing than academics. The perceived benefits of and barriers to involvement in research were similar among all groups, although older members of the public were more likely than academics to acknowledge potential barriers to involvement. academics and older people share some perceptions about PPI in ageing research, but members of the public are more optimistic about active involvement. Further correspondence between these groups may help to identify feasible involvement activities for older people and encourage collaborative research about ageing. © The Author 2014. Published by Oxford University Press on behalf of the British Geriatrics Society. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

Integrating: A managerial practice that enables implementation in fragmented health care environments.

PubMed

Kerrissey, Michaela; Satterstrom, Patricia; Leydon, Nicholas; Schiff, Gordon; Singer, Sara

How some organizations improve while others remain stagnant is a key question in health care research. Studies identifying how organizations can implement improvement despite barriers are needed, particularly in primary care. This inductive qualitative study examines primary care clinics implementing improvement efforts in order to identify mechanisms that enable implementation despite common barriers, such as lack of time and fragmentation across stakeholder groups. Using an embedded multiple case study design, we leverage a longitudinal data set of field notes, meeting minutes, and interviews from 16 primary care clinics implementing improvement over 15 months. We segment clinics into those that implemented more versus those that implemented less, comparing similarities and differences. We identify interpersonal mechanisms promoting implementation, develop a conceptual model of our key findings, and test the relationship with performance using patient surveys conducted pre-/post-implementation. Nine clinics implemented more successfully over the study period, whereas seven implemented less. Successfully implementing clinics exhibited the managerial practice of integrating, which we define as achieving unity of effort among stakeholder groups in the pursuit of a shared and mutually developed goal. We theorize that integrating is critical in improvement implementation because of the fragmentation observed in health care settings, and we extend theory about clinic managers' role in implementation. We identify four integrating mechanisms that clinic managers enacted: engaging groups, bridging communication, sensemaking, and negotiating. The mean patient survey results for integrating clinics improved by 0.07 units over time, whereas the other clinics' survey scores declined by 0.08 units on a scale of 5 (p = .02). Our research explores an understudied element of how clinics can implement improvement despite barriers: integrating stakeholders within and outside the clinic into the process. It provides clinic managers with an actionable path for implementing improvement.

Customized laboratory information management system for a clinical and research leukemia cytogenetics laboratory.

PubMed

Bakshi, Sonal R; Shukla, Shilin N; Shah, Pankaj M

2009-01-01

We developed a Microsoft Access-based laboratory management system to facilitate database management of leukemia patients referred for cytogenetic tests in regards to karyotyping and fluorescence in situ hybridization (FISH). The database is custom-made for entry of patient data, clinical details, sample details, cytogenetics test results, and data mining for various ongoing research areas. A number of clinical research laboratoryrelated tasks are carried out faster using specific "queries." The tasks include tracking clinical progression of a particular patient for multiple visits, treatment response, morphological and cytogenetics response, survival time, automatic grouping of patient inclusion criteria in a research project, tracking various processing steps of samples, turn-around time, and revenue generated. Since 2005 we have collected of over 5,000 samples. The database is easily updated and is being adapted for various data maintenance and mining needs.

Theory-driven group-based complex intervention to support self-management of osteoarthritis and low back pain in primary care physiotherapy: protocol for a cluster randomised controlled feasibility trial (SOLAS)

PubMed Central

Hurley, Deirdre A; Hall, Amanda M; Currie-Murphy, Laura; Pincus, Tamar; Kamper, Steve; Maher, Chris; McDonough, Suzanne M; Lonsdale, Chris; Walsh, Nicola E; Guerin, Suzanne; Segurado, Ricardo; Matthews, James

2016-01-01

Introduction International clinical guidelines consistently endorse the promotion of self-management (SM), including physical activity for patients with chronic low back pain (CLBP) and osteoarthritis (OA). Patients frequently receive individual treatment and advice to self-manage from physiotherapists in primary care, but the successful implementation of a clinical and cost-effective group SM programme is a key priority for health service managers in Ireland to maximise long-term outcomes and efficient use of limited and costly resources. Methods/analysis This protocol describes an assessor-blinded cluster randomised controlled feasibility trial of a group-based education and exercise intervention underpinned by self-determination theory designed to support an increase in SM behaviour in patients with CLBP and OA in primary care physiotherapy. The primary care clinic will be the unit of randomisation (cluster), with each clinic randomised to 1 of 2 groups providing the Self-management of Osteoarthritis and Low back pain through Activity and Skills (SOLAS) intervention or usual individual physiotherapy. Patients are followed up at 6 weeks, 2 and 6 months. The primary outcomes are the (1) acceptability and demand of the intervention to patients and physiotherapists, (2) feasibility and optimal study design/procedures and sample size for a definitive trial. Secondary outcomes include exploratory analyses of: point estimates, 95% CIs, change scores and effect sizes in physical function, pain and disability outcomes; process of change in target SM behaviours and selected mediators; and the cost of the intervention to inform a definitive trial. Ethics/dissemination This feasibility trial protocol was approved by the UCD Human Research Ethics—Sciences Committee (LS-13-54 Currie-Hurley) and research access has been granted by the Health Services Executive Primary Care Research Committee in January 2014. The study findings will be disseminated to the research, clinical and health service communities through publication in peer-reviewed journals, presentation at national and international academic and clinical conferences. Trial registration number ISRCTN 49875385; Pre-results. PMID:26801470

Using Digital Technologies in Clinical HIV Research: Real-World Applications and Considerations for Future Work.

PubMed

Andriesen, Jessica; Bull, Sheana; Dietrich, Janan; Haberer, Jessica E; Van Der Pol, Barbara; Voronin, Yegor; Wall, Kristin M; Whalen, Christopher; Priddy, Frances

2017-07-31

Digital technologies, especially if used in novel ways, provide a number of potential advantages to clinical research in trials related to human immunodeficiency virus (HIV) and acquired immune deficiency syndrome (AIDS) and may greatly facilitate operations as well as data collection and analysis. These technologies may even allow answering questions that are not answerable with older technologies. However, they come with a variety of potential concerns for both the participants and the trial sponsors. The exact challenges and means for alleviation depend on the technology and on the population in which it is deployed, and the rapidly changing landscape of digital technologies presents a challenge for creating future-proof guidelines for technology application. The aim of this study was to identify and summarize some common themes that are frequently encountered by researchers in this context and highlight those that should be carefully considered before making a decision to include these technologies in their research. In April 2016, the Global HIV Vaccine Enterprise surveyed the field for research groups with recent experience in novel applications of digital technologies in HIV clinical research and convened these groups for a 1-day meeting. Real-world uses of various technologies were presented and discussed by 46 attendees, most of whom were researchers involved in the design and conduct of clinical trials of biomedical HIV prevention and treatment approaches. After the meeting, a small group of organizers reviewed the presentations and feedback obtained during the meeting and categorized various lessons-learned to identify common themes. A group of 9 experts developed a draft summary of the findings that was circulated via email to all 46 attendees for review. Taking into account the feedback received, the group finalized the considerations that are presented here. Meeting presenters and attendees discussed the many successful applications of digital technologies to improve research outcomes, such as those for recruitment and enrollment, participant identification, informed consent, data collection, data quality, and protocol or treatment adherence. These discussions also revealed unintended consequence of technology usage, including risks to study participants and risks to study integrity. Key lessons learned from these discussions included the need to thoroughly evaluate systems to be used, the idea that early success may not be sustained throughout the study, that some failures will occur, and considerations for study-provided devices. Additionally, taking these key lessons into account, the group generated recommendations on how to move forward with the use of technology in HIV vaccine and biomedical prevention trials. ©Jessica Andriesen, Sheana Bull, Janan Dietrich, Jessica E Haberer, Barbara Van Der Pol, Yegor Voronin, Kristin M Wall, Christopher Whalen, Frances Priddy. Originally published in the Journal of Medical Internet Research (http://www.jmir.org), 31.07.2017.

Bridging the practitioner-scientist gap in group psychotherapy research.

PubMed

Lau, Mark A; Ogrodniczuk, John; Joyce, Anthony S; Sochting, Ingrid

2010-04-01

Bridging the practitioner-scientist gap requires a different clinical research paradigm: participatory research that encourages community agency-academic partnerships. In this context, clinicians help define priorities, determine the type of evidence that will have an impact on their practice (affecting the methods that are used to produce the evidence), and develop strategies for translating, implementing, and disseminating their findings into evidence-based practice. Within this paradigm, different roles are assumed by the partners, and sometimes these roles are blended. This paper will consider the perspectives of people who assume these different roles (clinician, researcher, and clinician-researcher) with group psychotherapy as the specific focus. Finally, the establishment of a practice-research network will be discussed as a potentially promising way to better engage group therapists in research.

Reforms speed initiation of NCI-sponsored clinical trials

Cancer.gov

The process of opening a cancer clinical trial for patient accrual often takes years, and research has shown that trials which are slow to register patients often fail to finish. Following a thorough review, NCI’s Operational Efficiency Working Group prod

An embedded randomised controlled trial of a Teaser Campaign to optimise recruitment in primary care.

PubMed

Lee, Hopin; Hübscher, Markus; Moseley, G Lorimer; Kamper, Steven J; Traeger, Adrian C; Skinner, Ian W; Williams, Christopher M; McAuley, James H

2017-04-01

Marketing communication and brand identity is a fundamental principle of advertising and end-user engagement. Health researchers have begun to apply this principle to trial recruitment in primary care. The aim of this study was to evaluate whether a Teaser Campaign using a series of postcards in advance of a conventional mail-out increases the number of primary care clinics that engage with a clinical trial. Embedded randomised recruitment trial across primary care clinics (general practitioners and physiotherapists) in the Sydney metropolitan area. Clinics in the Teaser Campaign group received a series of branded promotional postcards in advance of a standard letter inviting them to participate in a clinical trial. Clinics in the Standard Mail group did not receive the postcards. From a total of 744 clinics that were sent an invitation letter, 46 clinics in the Teaser Campaign group and 40 clinics in the Standard Mail group responded (11.6% total response rate). There was no between-group difference in the odds of responding to the invitation letter (odds ratio = 1.18, 95% confidence interval = 0.75-1.85, p = 0.49). For physiotherapy clinics and general practice clinics, the odds ratios were 1.43 (confidence interval = 0.82-2.48, p = 0.21) and 0.77 (confidence interval = 0.34-1.75, p  = 0.54), respectively. A Teaser Campaign using a series of branded promotional postcards did not improve clinic engagement for a randomised controlled trial in primary care.

Treatment of Opioid Dependent Pregnant Women: Clinical and Research Issues

PubMed Central

Jones, H.E.; Martin, P.R.; Heil, S.H.; Stine, S.M.; Kaltenbach, K.; Selby, P.; Coyle, M.G.; O’Grady, K.E.; Arria, A.M.; Fischer, G.

2008-01-01

This paper addresses common questions that clinicians face when treating pregnant women with opioid dependence. Guidance is provided to aid clinical decision-making, based on both research evidence and the collective clinical experience of the authors which include investigators in the Maternal Opioid Treatment: Human Experimental Research (MOTHER) project. MOTHER is a double-blind, double-dummy, flexible–dosing, parallel-group clinical trial examining the comparative safety and efficacy of methadone and buprenorphine for the opioid dependence treatment among pregnant women and their neonates. The paper begins with a discussion of appropriate assessment during pregnancy, and then addresses clinical management stages, including maintenance medication selection, induction and stabilization, opioid agonist medication management before, during and after delivery, pain management, breast-feeding, and transfer to aftercare. Lastly, other important clinical issues including managing co-occurring psychiatric disorders and medication interactions are discussed. PMID:18248941

Building Capacity for Research and Audit: Outcomes of a Training Workshop for Pacific Physicians and Nurses

ERIC Educational Resources Information Center

Ekeroma, Alec J.; Kenealy, Tim; Shulruf, Boaz; Nosa, Vili; Hill, Andrew

2015-01-01

Building the research capacity of clinicians in the Pacific Island countries is important in addressing evidence gaps relevant to local policy and clinical practice. This paper aimed to assess the effectiveness of a reproductive health research workshop in increasing research knowledge and intention to perform research amongst a diverse group of…

Perspectives on barriers and facilitators to minority recruitment for clinical trials among cancer center leaders, investigators, research staff, and referring clinicians: enhancing minority participation in clinical trials (EMPaCT).

PubMed

Durant, Raegan W; Wenzel, Jennifer A; Scarinci, Isabel C; Paterniti, Debora A; Fouad, Mona N; Hurd, Thelma C; Martin, Michelle Y

2014-04-01

The study of disparities in minority recruitment to cancer clinical trials has focused primarily on inquiries among minority populations. Yet very little is known about the perceptions of individuals actively involved in minority recruitment to clinical trials within cancer centers. Therefore, the authors assessed the perspectives of cancer center clinical and research personnel on barriers and facilitators to minority recruitment. In total, 91 qualitative interviews were conducted at 5 US cancer centers among 4 stakeholder groups: cancer center leaders, principal investigators, research staff, and referring clinicians. All interviews were recorded and transcribed. Qualitative analyses of response data was focused on identifying prominent themes related to barriers and facilitators to minority recruitment. The perspectives of the 4 stakeholder groups were largely overlapping with some variations based on their unique roles in minority recruitment. Four prominent themes were identified: 1) racial and ethnic minorities are influenced by varying degrees of skepticism related to trial participation, 2) potential minority participants often face multilevel barriers that preclude them from being offered an opportunity to participate in a clinical trial, 3) facilitators at both the institutional and participant level potentially encourage minority recruitment, and 4) variation between internal and external trial referral procedures may limit clinical trial opportunities for racial and ethnic minorities. Multilevel approaches are needed to address barriers and optimize facilitators within cancer centers to enhance minority recruitment for cancer clinical trials. © 2014 American Cancer Society.

The STARD statement for reporting diagnostic accuracy studies: application to the history and physical examination.

PubMed

Simel, David L; Rennie, Drummond; Bossuyt, Patrick M M

2008-06-01

The Standards for Reporting of Diagnostic Accuracy (STARD) statement provided guidelines for investigators conducting diagnostic accuracy studies. We reviewed each item in the statement for its applicability to clinical examination diagnostic accuracy research, viewing each discrete aspect of the history and physical examination as a diagnostic test. Nonsystematic review of the STARD statement. Two former STARD Group participants and 1 editor of a journal series on clinical examination research reviewed each STARD item. Suggested interpretations and comments were shared to develop consensus. The STARD Statement applies generally well to clinical examination diagnostic accuracy studies. Three items are the most important for clinical examination diagnostic accuracy studies, and investigators should pay particular attention to their requirements: describe carefully the patient recruitment process, describe participant sampling and address if patients were from a consecutive series, and describe whether the clinicians were masked to the reference standard tests and whether the interpretation of the reference standard test was masked to the clinical examination components or overall clinical impression. The consideration of these and the other STARD items in clinical examination diagnostic research studies would improve the quality of investigations and strengthen conclusions reached by practicing clinicians. The STARD statement provides a very useful framework for diagnostic accuracy studies. The group correctly anticipated that there would be nuances applicable to studies of the clinical examination. We offer guidance that should enhance their usefulness to investigators embarking on original studies of a patient's history and physical examination.

Effectiveness of a Psychoeducational Parenting Group on Child, Parent and Family Behavior: A Pilot Study in a Family Practice Clinic with an Underserved Population

PubMed Central

Berge, Jerica M.; Law, David D.; Johnson, Jennifer; Wells, M. Gawain

2013-01-01

Background Although integrated care for adults in primary care has steadily increased over the last several decades, there remains a paucity of research regarding integrated care for children in primary care. Purpose To report results of a pilot study testing initial feasibility of a parenting psychoeducational group targeting child behavioral problems within a primary care clinic. Method The participants (n = 35) were parents representing an underserved population from an inner-city primary care clinic. Participants attended a 12-week psychoeducational parenting group and reported pre- and post-measures of family functioning, child misbehavior and dyadic functioning. Paired t-tests and effects sizes are reported. Results Participants reported statistically significant improvement in family functioning, child misbehavior and couple functioning after participating in the parenting psychoeducational group. Conclusions Results suggest initial feasibility of a parenting psychoeducational group within a primary care clinic with an underserved population. This intervention may be useful for other primary care clinics seeking to offer more integrative care options for children and their families. PMID:20939627

Group Work with Transgender Clients

ERIC Educational Resources Information Center

Dickey, Lore M.; Loewy, Michael I.

2010-01-01

Drawing on the existing literature, the authors' research and clinical experiences, and the first author's personal journey as a member and leader of the transgender community, this article offers a brief history of group work with transgender clients followed by suggestions for group work with transgender clients from a social justice…

Development of a consensus core dataset in juvenile dermatomyositis for clinical use to inform research.

PubMed

McCann, Liza J; Pilkington, Clarissa A; Huber, Adam M; Ravelli, Angelo; Appelbe, Duncan; Kirkham, Jamie J; Williamson, Paula R; Aggarwal, Amita; Christopher-Stine, Lisa; Constantin, Tamas; Feldman, Brian M; Lundberg, Ingrid; Maillard, Sue; Mathiesen, Pernille; Murphy, Ruth; Pachman, Lauren M; Reed, Ann M; Rider, Lisa G; van Royen-Kerkof, Annet; Russo, Ricardo; Spinty, Stefan; Wedderburn, Lucy R; Beresford, Michael W

2018-02-01

This study aimed to develop consensus on an internationally agreed dataset for juvenile dermatomyositis (JDM), designed for clinical use, to enhance collaborative research and allow integration of data between centres. A prototype dataset was developed through a formal process that included analysing items within existing databases of patients with idiopathic inflammatory myopathies. This template was used to aid a structured multistage consensus process. Exploiting Delphi methodology, two web-based questionnaires were distributed to healthcare professionals caring for patients with JDM identified through email distribution lists of international paediatric rheumatology and myositis research groups. A separate questionnaire was sent to parents of children with JDM and patients with JDM, identified through established research networks and patient support groups. The results of these parallel processes informed a face-to-face nominal group consensus meeting of international myositis experts, tasked with defining the content of the dataset. This developed dataset was tested in routine clinical practice before review and finalisation. A dataset containing 123 items was formulated with an accompanying glossary. Demographic and diagnostic data are contained within form A collected at baseline visit only, disease activity measures are included within form B collected at every visit and disease damage items within form C collected at baseline and annual visits thereafter. Through a robust international process, a consensus dataset for JDM has been formulated that can capture disease activity and damage over time. This dataset can be incorporated into national and international collaborative efforts, including existing clinical research databases. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Clinical trials needed to evaluate compression therapy in breast cancer related lymphedema (BCRL). Proposals from an expert group.

PubMed

Partsch, H; Stout, N; Forner-Cordero, I; Flour, M; Moffatt, C; Szuba, A; Milic, D; Szolnoky, G; Brorson, H; Abel, M; Schuren, J; Schingale, F; Vignes, S; Piller, N; Döller, W

2010-10-01

A mainstay of lymphedema management involves the use of compression therapy. Compression therapy application is variable at different levels of disease severity. Evidence is scant to direct clinicians in best practice regarding compression therapy use. Further, compression clinical trials are fragmented and poorly extrapolable to the greater population. An ideal construct for conducting clinical trials in regards to compression therapy will promote parallel global initiatives based on a standard research agenda. The purpose of this article is to review current evidence in practice regarding compression therapy for BCRL management and based on this evidence, offer an expert consensus recommendation for a research agenda and prescriptive trials. Recommendations herein focus solely on compression interventions. This document represents the proceedings of a session organized by the International Compression Club (ICC) in June 2009 in Ponzano (Veneto, Italy). The purpose of the meeting was to enable a group of experts to discuss the existing evidence for compression treatment in breast cancer related lymphedema (BCRL) concentrating on areas where randomized controlled trials (RCTs) are lacking. The current body of research suggests efficacy of compression interventions in the treatment and management of lymphedema. However, studies to date have failed to adequately address various forms of compression therapy and their optimal application in BCRL. We offer recommendations for standardized compression research trials for prophylaxis of arm lymphedema and for the management of chronic BCRL. Suggestions are also made regarding; inclusion and exclusion criteria, measurement methodology and additional variables of interest for researchers to capture. This document should inform future research trials in compression therapy and serve as a guide to clinical researchers, industry researchers and lymphologists regarding the strengths, weaknesses and shortcomings of the current literature. By providing this construct for research trials, the authors aim to support evidence-based therapy interventions, promote a cohesive, standardized and informative body of literature to enhance clinical outcomes, improve the quality of future research trials, inform industry innovation and guide policy related to BCRL.

Las experiencias clinicas de los estudiantes de enfermeria: Estudio de caso hacia la integracion de la mentoria

NASA Astrophysics Data System (ADS)

Rivera Rodriguez, Ivelisse

Clinical experiences are an essential part of the training of future nursing professionals. The period of clinical experience aims to develop in the student the necessary skills to practice as a nursing professional, when the academic program ends. This case study aimed to understand the opinion and explore the perception of faculty, clinical instructors, and nursing students on the meaning, contributions and challenges presented during clinical experiences. Among the themes explored in the focus groups were the meaning and importance to learning about the profession of clinical experiences, teaching strategies used during the practice scenarios, didactic relationships developed among students, clinical instructors, and teachers. The goal was to learn from all participants about what they do, their expectations, and the challenges presented during the clinical experiences. A qualitative, descriptive and contextual research design was followed, which required conducting six focus groups to collect the information from the perspective of all the participants. Faculty, clinical instructors, and nursing students participated each in two focus groups. Collected data were transcribed, coded and analyzed in order to organize it under themes related to the research framework. The qualitative analysis of the focus groups revealed that nursing faculty and clinical instructors perceived clinical experiences as a very important element in the training of nursing students, but that coordination between the academy and practice scenarios is disconnected and needs improvement. They also expressed that they use various learning strategies during the clinical experiences, however, they recognize it needs more structure and suggested mentoring as a strategy to consider. They affirmed that mentoring could contribute positively to enhance the teaching-learning process. Clinical instructors understand they perform mentoring roles, but they would like to have a more defined role and structured process. Nursing students, also, recognized the importance of clinical experiences in their professional training. They expressed the need to improve the communication between the academy and the practice scenarios in order to reduce the levels of anxiety they experience when entering the clinical experiences. Nursing students also expressed the need to consider the use of different teaching strategies, such as mentoring, to improve clinical experiences.

75 FR 52536 - National Center for Research Resources; Notice of Closed Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2010-08-26

... Review Group, Comparative Medicine Review Committee CMRC. Date: October 14, 2010. Time: 8 a.m. to 5 p.m... Domestic Assistance Program Nos. 93.306, Comparative Medicine; 93.333, Clinical Research; 93.371...

75 FR 80063 - National Center for Research Resources; Notice of Closed Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2010-12-21

... Review Group. Comparative Medicine Review Committee. Date: February 16-17, 2011. Time: 8 a.m. to 5 p.m... Assistance Program Nos. 93.306, Comparative Medicine; 93.333, Clinical Research; 93.371, Biomedical...

Training the Translational Research Teams of the Future: UC Davis—HHMI Integrating Medicine into Basic Science Program

PubMed Central

Rainwater, Julie A.; Chiamvimonvat, Nipavan; Bonham, Ann C.; Robbins, John A.; Henderson, Stuart; Meyers, Frederick J.

2013-01-01

Abstract There is a need for successful models of how to recruit, train, and retain bench scientists at the earliest stages of their careers into translational research. One recent, promising model is the University of California Davis Howard Hughes Medical Institute Integrating Medicine into Basic Science (HHMI‐IMBS) program, part of the HHMI Med into Grad initiative. This paper outlines the HHMI‐IMBS program's logic, design, and curriculum that guide the goal of research that moves from bedside to bench. That is, a curriculum that provides graduate students with guided translational training, clinical exposure, team science competencies, and mentors from diverse disciplines that will advance the students careers in clinical translational research and re‐focusing of research to answer clinical dilemmas. The authors have collected data on 55 HHMI‐IMBS students to date. Many of these students are still completing their graduate work. In the current study the authors compare the initial two cohorts (15 students) with a group of 29 control students to examine the program success and outcomes. The data indicate that this training program provides an effective, adaptable model for training future translational researchers. HHMI‐IMBS students showed improved confidence in conducting translational research, greater interest in a future translational career, and higher levels of research productivity and collaborations than a comparable group of predoctoral students. PMID:24127920

Participation and successful patient recruitment in primary care.

PubMed

de Wit, N J; Quartero, A O; Zuithoff, A P; Numans, M E

2001-11-01

The demand for family physicians (FPs) to participate in research is growing. The delicate balance between research participation and the daily practice routine might explain the often-disappointing number of patients recruited. We analyzed practice and physician characteristics associated with successful patient recruitment. We used a survey to conduct this study. There was a total of 165 FPs who participated in a combined randomized clinical trial/cohort study on drug treatment of dyspepsia in the Netherlands. We surveyed FPs about personal and practice characteristics and their motivation for participation in the project. These data were then related to the number of patients recruited. Univariate associations were calculated; relevant factors were entered into a logistic model that predicted patient recruitment. Data on 128 FPs could be analyzed (80% response rate); these FPs recruited 793 patients in the cohort study (mean = 6.3 per FP) and 527 in the clinical trial (mean = 4.2 per FP). The main reasons for participation were the research topic (59%) and the participation of an academic research group in the study (63%). Many FPs felt that participation was a professional obligation (39%); the financial incentive played a minor role (15%). The number of recruited patients was only independently associated with the participation of an academic research group. Successful patient recruitment in primary care research is determined more by motivation driven by the research group than by financial incentives, the research topic, or research experience.

Clinical validity of prototype personality disorder ratings in adolescents.

PubMed

Defife, Jared A; Haggerty, Greg; Smith, Scott W; Betancourt, Luis; Ahmed, Zain; Ditkowsky, Keith

2015-01-01

A growing body of research shows that personality pathology in adolescents is clinically distinctive and frequently stable into adulthood. A reliable and useful method for rating personality pathology in adolescent patients has the potential to enhance conceptualization, dissemination, and treatment effectiveness. The aim of this study is to examine the clinical validity of a prototype matching approach (derived from the Shedler Westen Assessment Procedure-Adolescent Version) for quantifying personality pathology in an adolescent inpatient sample. Sixty-six adolescent inpatients and their parents or legal guardians completed forms of the Child Behavior Checklist (CBCL) assessing emotional and behavioral problems. Clinical criterion variables including suicide history, substance use, and fights with peers were also assessed. Patients' individual and group therapists on the inpatient unit completed personality prototype ratings. Prototype diagnoses demonstrated substantial reliability (median intraclass correlation coefficient =.75) across independent ratings from individual and group therapists. Personality prototype ratings correlated with the CBCL scales and clinical criterion variables in anticipated and meaningful ways. As seen in prior research with adult samples, prototype personality ratings show clinical validity across independent clinician raters previously unfamiliar with the approach, and they are meaningfully related to clinical symptoms, behavioral problems, and adaptive functioning.

Clinical Validity of Prototype Personality Disorder Ratings in Adolescents

PubMed Central

DeFife, Jared A.; Haggerty, Greg; Smith, Scott W.; Betancourt, Luis; Ahmed, Zain; Ditkowsky, Keith

2015-01-01

A growing body of research shows that personality pathology in adolescents is clinically distinctive and frequently stable into adulthood. A reliable and useful method for rating personality pathology in adolescent patients has the potential to enhance conceptualization, dissemination, and treatment effectiveness. The aim of this study is to examine the clinical validity of a prototype matching approach (derived from the Shedler Westen Assessment Procedure – Adolescent Version) for quantifying personality pathology in an adolescent inpatient sample. Sixty-six adolescent inpatients and their parents or legal guardians completed forms of the Child Behavior Checklist (CBCL) assessing emotional and behavioral problems. Clinical criterion variables including suicide history, substance use, and fights with peers were also assessed. Patients’ individual and group therapists on the inpatient unit completed personality prototype ratings. Prototype diagnoses demonstrated substantial reliability (median ICC = .75) across independent ratings from individual and group therapists. Personality prototype ratings correlated with the CBCL scales and clinical criterion variables in anticipated and meaningful ways. As seen in prior research with adult samples, prototype personality ratings show clinical validity across independent clinician raters previously unfamiliar with the approach, and they are meaningfully related to clinical symptoms, behavioral problems, and adaptive functioning. PMID:25457971

A Quality Improvement Initiative to Increase Colorectal Cancer (CRC) Screening: Collaboration between a Primary Care Clinic and Research Team

PubMed Central

Green, Beverly B.; Fuller, Sharon; Anderson, Melissa L.; Mahoney, Christine; Mendy, Peter; Powell, Susan L.

2017-01-01

Background Multiple randomized controlled trials have demonstrated that mailed fecal testing programs are effective in increasing colorectal cancer screening participation. However, few healthcare organization in the US have Implemented such programs. Methods Stakeholders from one clinic in an integrated healthcare system in Washington State initiated collaboration with researchers with expertise in CRC screening, aiming to increase screening rates at their clinic. Age-eligible individuals who were overdue for CRC screening and had previously completed a fecal test were randomized to receive mailed fecal immunochemical test kits (FIT) at the start of the project (Early) or 6 months later (Late). Outcomes included comparing FIT completion at 6 months by randomization group, and overall CRC screening rates at 12 months. We also assessed implementation facilitators and challenges. Results Overall 2,421 FIT tests were mailed at a cost of $10,739. At 6 months, FIT completion was significantly higher among the Early compared to the Late group (62% vs.47%, p <0.001). By 12 months, after both groups had received mailings, 71% in each group had completed a FIT. The clinic’s overall CRC screening rate was 75.1% at baseline and 78.0% 12 months later. Key constructs associated with successful program implementation included strong stakeholder involvement, use of evidence-based strategies, simplicity, and low cost. Challenges included lack of a plan for maintaining the program. Discussion Collaboration between clinic stakeholders and researchers led to a successful project that rapidly increased CRC screening rates. However, institutional normalization of the program would be required to maintain it. PMID:29399669

Global Health and Emergency Care: Defining Clinical Research Priorities.

PubMed

Hansoti, Bhakti; Aluisio, Adam R; Barry, Meagan A; Davey, Kevin; Lentz, Brian A; Modi, Payal; Newberry, Jennifer A; Patel, Melissa H; Smith, Tricia A; Vinograd, Alexandra M; Levine, Adam C

2017-06-01

Despite recent strides in the development of global emergency medicine (EM), the field continues to lag in applying a scientific approach to identifying critical knowledge gaps and advancing evidence-based solutions to clinical and public health problems seen in emergency departments (EDs) worldwide. Here, progress on the global EM research agenda created at the 2013 Academic Emergency Medicine Global Health and Emergency Care Consensus Conference is evaluated and critical areas for future development in emergency care research internationally are identified. A retrospective review of all studies compiled in the Global Emergency Medicine Literature Review (GEMLR) database from 2013 through 2015 was conducted. Articles were categorized and analyzed using descriptive quantitative measures and structured data matrices. The Global Emergency Medicine Think Tank Clinical Research Working Group at the Society for Academic Emergency Medicine 2016 Annual Meeting then further conceptualized and defined global EM research priorities utilizing consensus-based decision making. Research trends in global EM research published between 2013 and 2015 show a predominance of observational studies relative to interventional or descriptive studies, with the majority of research conducted in the inpatient setting in comparison to the ED or prehospital setting. Studies on communicable diseases and injury were the most prevalent, with a relative dearth of research on chronic noncommunicable diseases. The Global Emergency Medicine Think Tank Clinical Research Working Group identified conceptual frameworks to define high-impact research priorities, including the traditional approach of using global burden of disease to define priorities and the impact of EM on individual clinical care and public health opportunities. EM research is also described through a population lens approach, including gender, pediatrics, and migrant and refugee health. Despite recent strides in global EM research and a proliferation of scholarly output in the field, further work is required to advocate for and inform research priorities in global EM. The priorities outlined in this paper aim to guide future research in the field, with the goal of advancing the development of EM worldwide. © 2017 by the Society for Academic Emergency Medicine.

Challenges in the transition to clinical training in dentistry: An ADEE special interest group initial report.

PubMed

Serrano, C M; Botelho, M G; Wesselink, P R; Vervoorn, J M

2018-02-03

Curricular integration in higher education has been widely supported in the educational literature. As a result, several health care and specifically dental curricula have evolved from compartmentalised disciplinary training to integrated modalities; however, in many courses, a pre-clinical-clinical watershed remains a barrier to integration in dental education. This article introduces a general description of the pre-clinical-clinical transition in dentistry according to the outcomes of the discussion held during the first working group session of the "Transition to Clinical Training" Special Interest Group during the 2016 annual meeting of the Association for Dental Education in Europe. An online questionnaire was made available before the meeting to survey the curricular characteristics of the participants' schools. During the meeting, a working session related to the pre-clinical-clinical transition occurred. Conclusions from the discussion are summarised in this article. Fourteen dental schools from 12 countries participated in the online survey. The included programmes had an average duration of 5.3 years (SD = 0.48), with high school or the local equivalent as the required entrance level for dentistry. The hybrid curriculum was the leading curriculum design (n = 9) followed by competence-based curricula (n = 3), with patient treatment as the core of clinical training in every included programme. The pre-clinical-clinical transition in dentistry is a recognisable matter in dental education that requires assessment and research to ease the management of a stage with relevant influence on educational outcomes. This article presents an initial framework for further research and educational intervention. © 2018 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Research planning for the future of psychiatric diagnosis.

PubMed

Regier, D A; Kuhl, E A; Narrow, W E; Kupfer, D J

2012-10-01

More than 10 years prior to the anticipated 2013 publication of DSM-5, processes were set in motion to assess the research and clinical issues that would best inform future diagnostic classification of mental disorders. These efforts intended to identify the clinical and research needs within various populations, examine the current state of the science to determine the empirical evidence for improving criteria within and across disorders, and stimulate research in areas that could potentially provide evidence for change. In the second phase of the revision process, the American Psychiatric Institute for Research and Education (APIRE) recently completed the 5-year international series of 13 diagnostic conferences convened by APA/APIRE in collaboration with the World Health Organization and the National Institutes of Health (NIH), under a cooperative grant funded by the NIH. From these conferences, the DSM-5 Task Force and Work Groups have developed plans for potential revisions for DSM-5, including the incorporation of dimensional approaches within and across diagnostic groups to clarify heterogeneity, improve diagnostic validity, and enhance clinical case conceptualization. Use of dimensions for measurement-based care has been shown to be feasible in psychiatric and primary care settings and may inform monitoring of disorder threshold, severity, and treatment outcomes. The integration of dimensions with diagnostic categories represents an exciting and potentially transformative approach for DSM-5 to simultaneously address DSM-IV's clinical short-comings and create novel pathways for research in neurobiology, genetics, and psychiatric epidemiology. Copyright © 2011 Elsevier Masson SAS. All rights reserved.

A quality-refinement process for medical imaging applications.

PubMed

Neuhaus, J; Maleike, D; Nolden, M; Kenngott, H-G; Meinzer, H-P; Wolf, I

2009-01-01

To introduce and evaluate a process for refinement of software quality that is suitable to research groups. In order to avoid constraining researchers too much, the quality improvement process has to be designed carefully. The scope of this paper is to present and evaluate a process to advance quality aspects of existing research prototypes in order to make them ready for initial clinical studies. The proposed process is tailored for research environments and therefore more lightweight than traditional quality management processes. Focus on quality criteria that are important at the given stage of the software life cycle. Usage of tools that automate aspects of the process is emphasized. To evaluate the additional effort that comes along with the process, it was exemplarily applied for eight prototypical software modules for medical image processing. The introduced process has been applied to improve the quality of all prototypes so that they could be successfully used in clinical studies. The quality refinement yielded an average of 13 person days of additional effort per project. Overall, 107 bugs were found and resolved by applying the process. Careful selection of quality criteria and the usage of automated process tools lead to a lightweight quality refinement process suitable for scientific research groups that can be applied to ensure a successful transfer of technical software prototypes into clinical research workflows.

The face, the future, and dental practice: how research in craniofacial biology will influence patient care.

PubMed

Townsend, G C; Brook, A H

2014-06-01

It has been a privilege to assemble a group of Australian and international researchers to produce a special issue of the Australian Dental Journal that reflects the cutting edge of research in different aspects of craniofacial biology, and also considers how these advances will influence future education and practice within dentistry. The aim of this special issue is to provide a collection of concept papers and critical reviews on key topics that cover both fundamental and applied research in craniofacial biology and to consider the clinical implications. To do this, four questions have been addressed that lead to the four sections of this issue. These are: How have we come to the present exciting position in craniofacial biology with breakthroughs over the past 50 years? What are current fundamental research topics that are helping us to understand more about craniofacial and general development, possibly leading to future clinical developments? What are the current applied research topics that will influence future clinical practice? Looking forward, what new developments in craniofacial biology may come about that will change the face of dental education and practice? The refereed papers in this special issue are grouped into the four sections that seek to respond to these demanding questions. © 2014 Australian Dental Association.

The future of research in female pelvic medicine.

PubMed

Chao, Jamie; Chai, Toby C

2015-02-01

Female pelvic medicine and reconstructive surgery (FPMRS) was recently recognized as a subspecialty by the American Board of Medical Specialties (ABMS). FPMRS treats female pelvic disorders (FPD) including pelvic organ prolapse (POP), urinary incontinence (UI), fecal incontinence (FI), lower urinary tract symptoms (LUTS), lower urinary tract infections (UTI), pelvic pain, and female sexual dysfunction (FSD). These conditions affect large numbers of individuals, resulting in significant patient, societal, medical, and financial burdens. Given that treatments utilize both medical and surgical approaches, areas of research in FPD necessarily cover a gamut of topics, ranging from mechanistically driven basic science research to randomized controlled trials. While basic science research is slow to impact clinical care, transformational changes in a field occur through basic investigations. On the other hand, clinical research yields incremental changes to clinical care. Basic research intends to change understanding whereas clinical research intends to change practice. However, the best approach is to incorporate both basic and clinical research into a translational program which makes new discoveries and effects positive changes to clinical practice. This review examines current research in FPD, with focus on translational potential, and ponders the future of FPD research. With a goal of improving the care and outcomes in patients with FPD, a strategic collaboration of stakeholders (patients, advocacy groups, physicians, researchers, professional medical associations, legislators, governmental biomedical research agencies, pharmaceutical companies, and medical device companies) is an absolute requirement in order to generate funding needed for FPD translational research.

[Organising an investigation site: a national training reference document].

PubMed

Cornu, Catherine; David, Frédérique; Duchossoy, Luc; Hansel-Esteller, Sylvie; Bertoye, Pierre-Henri; Giacomino, Alain; Mouly, Stéphane; Diebolt, Vincent; Blazejewski, Sylvie

2014-01-01

Several surveys have shown a declining performance of French investigators in conducting clinical trials. This is partly due to insufficient and heterogeneous investigator training and site organisation. A multidisciplinary group was set up to propose solutions. We describe the tools developed to improve study site organisation. This working group was made up of clinical research experts from academia, industry, drug regulatory authorities, general practice, and consulting. Methods and tools were developed to improve site organisation. The proposed tools mainly focus on increasing investigators' awareness of their responsibilities, their research environment, the importance of a thorough feasibility analysis, and the implementation of active patient recruitment strategies. These tools should be able to improve site organisation and performances in conducting clinical trials. © 2014 Société Française de Pharmacologie et de Thérapeutique.

Operative treatment and avascular necrosis of the hip development disorder.

PubMed

Gavrankapetanović, Ismet; Hadžimehmedagić, Amel; Papović, Adnan; Baždar, Elvir

2014-07-01

The purpose of this research was (1) to evaluate the consequences of an operative treatment of hip developmental disorder in children, (2) to evaluate the significance of hip vascular supply in children through indirect radiological signs, such as morphological changes on femoral head, and to classify them with standard classification methods, and (3) to analyse the research results and make a recommendation for the following treatment dilemma: when is the optimal time for an operative treatment of a hip development disorder? The research is a retrospective and observational analysis based on the classification of indirect radiological signs of local vascular disorder by the Bucholz-Ogden's scale. Materials used for this research are medical records of treated patients at the Clinic for Orthopaedics and Traumatology of the Sarajevo University Clinical Centre. Using a random selection, two groups of 30 patients with hip development disorder were formed. The first group was comprised of patients aged six to 18 months and the second group of patients aged 18-60 months. The medical records used for this research included all necessary anamnestic details and postoperative state treatments with clinical findings and regular radiological check-up findings that include the presence or absence of the ossification nucleus as well as its position. All patients underwent surgery with the same operative technique. Data analysis points include the state at the beginning of the treatment, the postoperative state, the state at discharge as well as control findings that followed the development of the proximal femoral part up to 72 months on average. The analysis covered data such as age, sex, family anamnestic data, clinical findings and radiological findings regarding the femoral head morphology (appearance, size, shape, position and indirect signs showing lack of vascular supply). In addition, data analysis included the types of any previous conservative or operative treatments, the duration of previous conservative treatments and repeated hospitalization. In group 1, 86.6 % were female patients and 80 % in group 2. Family history was positive in 15.6 % in group 1 and 13.3 % in group 2. A total of 51.6 % of all patients started walking on time, while the rest had problems with verticalization. Of all patients, 47 % did not undergo any kind of prior treatment. Only 62.2 % of group 1 patients had ossification nucleus present, while the entire group 2 had it present. Results showed that 24.32 % of group 1 patients had none or minimal signs of avascular necrosis (AVN) while 39.47 % of group 2 had none or minimal signs of AVN; 60.52 % of group 2 patients had signs of AVN. The results of this study show that the performance of a surgical treatment during the age between 12 and 20 months is burdened by the highest percentage of avascular necrosis. Even though AVN can be noticed in other age groups, according to the results of our research, it seems that vascular supply of the hip is the most vulnerable in the period between 12 and 20 months.

Bioethical Issues in Conducting Pediatric Dentistry Clinical Research.

PubMed

Garrocho-Rangel, Arturo; Cerda-Cristerna, Bernardino; Pozos-Guillen, Amaury

Pediatric clinical research on new drugs and biomaterials involves children in order to create valid and generalizable knowledge. Research on vulnerable populations, such as children, is necessary but only admissible when researchers strictly follow methodological and ethical standards, together with the respect to human rights; and very especially when the investigation cannot be conducted with other population or when the potential benefits are specifically for that age group. Clinical research in Pediatric Dentistry is not an exception. The aim of the present article was to provide the bioethical principles (with respect to the child/parents' autonomy, benefit/risk analysis, and distributive justice), and recommendations, including informed consent, research ethics committees, conflict of interest, and the "equipoise" concept. Current and future worldwide oral health research in children and adolescents must be conducted incorporating their perspectives in the decision-making process as completely as possible. This concept must be carefully considered when a dental clinical study research is going to be planned and conducted, especially in the case of randomized controlled trials, in which children will be recruited as participants.

Building a bridge for nursing education and clinical care in Taiwan--using action research and Confucian tradition to close the gap.

PubMed

Yang, Wan-Ping; Chao, Co-Shi Chantal; Lai, Wei-Shu; Chen, Ching-Huey; Shih, Ya Lan; Chiu, Ge-Lin

2013-03-01

Nursing workplaces in Taiwan are unable to retain talent. An examination of this problem has revealed that the causes of this phenomenon are that nursing education fails to cultivate the skills that meet workplace requirements and that there are gap between nursing education and clinical practice. This paper is an action research that aims is to design educational programs that can close the gap between nursing education and clinical practice in Taiwan. In this action research project, 4 action cycles were used to design educational programs including concept mapping and focused discussion strategies. Participants were invited to join the research in three teaching hospitals and one university. Two groups of participants, student nurses (SN) and nursing staff personnel (NS), were sampled and invited to participate in the research. Participant observation, focus groups, and qualitative interviews were used to collect data. Qualitative data were not only profiled by content analysis, but they were also compared continuously between the two groups as well as between the 4 cycles. The qualitative data collected for the 135 participants were analysed. The themes of an effective nursing program were summarized. Many fundamental values of traditional Chinese education have gradually faded due to the Westernization of education. In this study, we discovered that Western educational models may play a critical role in improving traditionally taught nursing education programs. Copyright © 2012 Elsevier Ltd. All rights reserved.

TU-EF-210-04: AAPM Task Groups in Interventional Ultrasound Imaging and Therapy

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

Farahani, K.

The use of therapeutic ultrasound to provide targeted therapy is an active research area that has a broad application scope. The invited talks in this session will address currently implemented strategies and protocols for both hyperthermia and ablation applications using therapeutic ultrasound. The role of both ultrasound and MRI in the monitoring and assessment of these therapies will be explored in both pre-clinical and clinical applications. Katherine Ferrara: High Intensity Focused Ultrasound, Drug Delivery, and Immunotherapy Rajiv Chopra: Translating Localized Doxorubicin Delivery to Pediatric Oncology using MRI-guided HIFU Elisa Konofagou: Real-time Ablation Monitoring and Lesion Quantification using Harmonic Motion Imagingmore » Keyvan Farahani: AAPM Task Groups in Interventional Ultrasound Imaging and Therapy Learning Objectives: Understand the role of ultrasound in localized drug delivery and the effects of immunotherapy when used in conjunction with ultrasound therapy. Understand potential targeted drug delivery clinical applications including pediatric oncology. Understand the technical requirements for performing targeted drug delivery. Understand how radiation-force approaches can be used to both monitor and assess high intensity focused ultrasound ablation therapy. Understand the role of AAPM task groups in ultrasound imaging and therapies. Chopra: Funding from Cancer Prevention and Research Initiative of Texas (CPRIT), Award R1308 Evelyn and M.R. Hudson Foundation; Research Support from Research Contract with Philips Healthcare; COI are Co-founder of FUS Instruments Inc Ferrara: Supported by NIH, UCDavis and California (CIRM and BHCE) Farahani: In-kind research support from Philips Healthcare.« less

Clinical Trials: A Congressional Focus of Need.

PubMed

Coltman

1997-01-01

Senator Specter, Honorable Members of the Committee, it is my high privilege to speak on behalf of a subject near and dear to my heart. I have been involved in the care of patients with cancer and in cancer clinical trials for the past 34 years. I chair the Southwest Oncology Group, the largest National Cancer Institute-supported cancer clinical research organization. In 1996, this Group enrolled 6,359 patients to therapeutic cancer clinical trials from all 50 states (Fig. 1), and completed the randomization of 18,867 normal, healthy men into the intergroup Prostate Cancer Prevention Trial. Cancer clinical trials are always designed to improve the outcomes of cancer patients. However, only 2%-3% of all eligible cancer patients in this country are treated on these cutting-edge trials. It is clear that this number must increase dramatically in order for us to be able to translate the monumental advances emanating from the basic cancer research laboratories into effective diagnosis, prevention and treatment strategies for patients with and at high risk for cancer. This low accrual is related to multiple factors: First, managed care has had a negative impact related to its refusal to reimburse for the clinical care aspects of patients on cancer clinical trials. During my presentation to the President's Cancer Panel in San Antonio in September, I shared three thoughts as to what the Panel should be asking as they pursue the question of "Managed Care's Role in the War on Cancer": &bul; "Should managed care bear a portion of the costs of clinical research as a form of R & D?" &bul; "What State or Federal legislation is needed to assure that managed care patients have access to cancer clinical research?" &bul; "Will there be any future for cancer clinical research when the managed care tidal wave finally reaches Chicago and New York?" The NCI-Department of Defense and the NCI-Department of Veterans Affairs Interagency Agreements are superb models of what needs to be done for the rest of managed care. Secondly, the Southwest Oncology Group is outstripping its financial support at its current rate of accrual. Even if the managed care problem was resolved, there must be more money to support clinical research to translate this plethora of science to patients with cancer. I am also Director of the San Antonio Cancer Institute, a National Cancer Institute-designated Comprehensive Cancer Center. A recent astonishingly productive Breast Cancer Program Project Grant received a priority score one point below the pay line. While this grant will undoubtedly be funded by exception, it is representative of a nationwide problem of insufficient funds to support truly outstanding research. The following quote is from another Cancer Center Director, who is also a Cooperative Group Chair: "We never know where the next breakthrough will come from. Every time we discover a new gene, we also have a new marker for early diagnosis, a new predictor of response to therapy, a new target for chemoprevention, as well as for cancer treatment. Every discovery in a Cancer Center provides fuel for the Cooperative Group program, and requires affirmation in large clinical trials. Thus, the universe of cancer research is a continuum, (where) improved funding for any of it, impacts all of it, and improved funding for all of it will hasten the pace of discovery throughout." (Richard L. Schilsky, M.D.) Finally, I would like to paraphrase a futurist that I recently heard: &bul; "The present is obsolete." &bul; "The future has already been discovered" in the laboratories of molecular biologists throughout this country! We must search among those discoveries for the keys to cancer cures. &bul; "We are confronted with insurmountable opportunities!" &bul; "These new tools will change the rules of the game!" &bul; "We should not manage change, we should love change and make change our best friend," as all those involved in cancer research and the Congress must do every day. (Don Burrus) Thank you for your attention.

The clinician-scientist: professional dynamics in clinical stem cell research.

PubMed

Wilson-Kovacs, Dana M; Hauskeller, Christine

2012-05-01

Clinical applications of biomedical research rely on specialist knowledge provided by professionals who straddle research and therapy, and possess both medical and scientific expertise. To date, this professional group remains under-explored in sociology. Our article presents a case study of clinician-scientists working in stem cell research for heart repair in the UK and Germany who are engaged in double-blind randomised clinical trials using patients' own stem cells. The analysis draws on sociological and medical literature, interviews and ethnographic fieldwork to analyse the experiences and self-rationalisations of a small number of clinician-scientists and the ways in which these professionals portray, explain and justify their role in the wider clinical research environment. We examine our participants' views on the clinical trials they conduct, the challenges they encounter and the ways through which they negotiate a complex disciplinary terrain, and argue that the recent clinical implementation of stem cell research brings clinician-scientists to the fore and provides a renewed platform for their professional legitimisation. The article helps increase our understanding of how randomised clinical trials are involved in consolidating the individual status of actors and the collective standing of clinician-scientists as leaders of change in translational medicine. © 2011 The Authors. Sociology of Health & Illness © 2011 Foundation for the Sociology of Health & Illness/Blackwell Publishing Ltd.

Improved participants' understanding of research information in real settings using the SIDCER informed consent form: a randomized-controlled informed consent study nested with eight clinical trials.

PubMed

Koonrungsesomboon, Nut; Tharavanij, Thipaporn; Phiphatpatthamaamphan, Kittichet; Vilaichone, Ratha-Korn; Manuwong, Sudsayam; Curry, Parichat; Siramolpiwat, Sith; Punchaipornpon, Thanachai; Kanitnate, Supakit; Tammachote, Nattapol; Yamprasert, Rodsarin; Chanvimalueng, Waipoj; Kaewkumpai, Ruchirat; Netanong, Soiphet; Kitipawong, Peerapong; Sritipsukho, Paskorn; Karbwang, Juntra

2017-02-01

This study aimed to test the applicability and effectiveness of the principles and informed consent form (ICF) template proposed by the Strategic Initiative for Developing Capacity in Ethical Review (SIDCER) across multiple clinical trials involving Thai research participants with various conditions. A single-center, randomized-controlled study nested with eight clinical trials was conducted at Thammasat University Hospital, Thailand. A total of 258 participants from any of the eight clinical trials were enrolled and randomly assigned to read either the SIDCER ICF (n = 130) or the conventional ICF (n = 128) of the respective trial. Their understanding of necessary information was assessed using the post-test questionnaire; they were allowed to consult a given ICF while completing the questionnaire. The primary endpoint was the proportion of the participants who had the post-test score of ≥80%, and the secondary endpoint was the total score of the post-test. The proportion of the participants in the SIDCER ICF group who achieved the primary endpoint was significantly higher than that of the conventional ICF group (60.8 vs. 41.4%, p = 0.002). The total score of the post-test was also significantly higher among the participants who read the SIDCER ICF than those who read the conventional ICF (83.3 vs. 76.0%, p < 0.001). The present study demonstrated that the SIDCER ICF was applicable and effective to improve Thai research participants' understanding of research information in diverse clinical trials. Using the SIDCER ICF methodology, clinical researchers can improve the quality of ICFs for their trials.

[Analysis of scientific production and bibliometric impact of a group of Spanish clinical researchers].

PubMed

Miró, O; Burbano Santos, P; Trilla, A; Casademont, J; Fernandez Pérez, C; Martín-Sánchez, Fj

2016-01-01

To study the behaviour of several indicators of scientific production and repercussion in a group of Spanish clinical researchers and to evaluate their possible utility for interpreting individual or collective scientific pathways. We performed a unicentric, ecological pilot study involving a group of physicians with consolidated research experience. From the Science Citation Index Expanded (SCI-Expanded) database, we obtained the number of publications of each author (indicator of production) and the number of citations, impact factor and h index (indicators of repercussion). These indicators were calculated individually for each of the years of research experience and we assessed the relationship between the experience of the researcher and the value of the indicator achieved, the relationship between these indicators themselves, and their temporal evolution, both individually and for the entire group. We analysed 35 researchers with a research experience of 28.4 (9.6) years. The h index showed the lowest coefficient of variance. The relationship between the indicators and research experience was significant, albeit modest (R2 between 0.15-0.22). The 4 indicators showed good correlations. The temporal evolution of the indicators, both individual and collective, adjusted better to a second grade polynomial than a linear function: individually, all the authors obtained R2>0.90 in all the indicators; together the best adjustment was produced with the h index (R2=0.61). Based on the indicator used, substantial variations may be produced in the researchers' ranking. A model of the temporal evolution of the indicators of production and repercussion can be described in a relatively homogeneous sample of researchers and the h index seems to demonstrate certain advantages compared to the remaining indicators. This type of analysis could become a predictive tool of performance to be achieved not only for a particular researcher, but also for a homogeneous group of resear-chers corresponding to a specific scientific niche.

Involving service users in trials: developing a standard operating procedure

PubMed Central

2013-01-01

Background Many funding bodies require researchers to actively involve service users in research to improve relevance, accountability and quality. Current guidance to researchers mainly discusses general principles. Formal guidance about how to involve service users operationally in the conduct of trials is lacking. We aimed to develop a standard operating procedure (SOP) to support researchers to involve service users in trials and rigorous studies. Methods Researchers with experience of involving service users and service users who were contributing to trials collaborated with the West Wales Organisation for Rigorous Trials in Health, a registered clinical trials unit, to develop the SOP. Drafts were prepared in a Task and Finish Group, reviewed by all co-authors and amendments made. Results We articulated core principles, which defined equality of service users with all other research team members and collaborative processes underpinning the SOP, plus guidance on how to achieve these. We developed a framework for involving service users in research that defined minimum levels of collaboration plus additional consultation and decision-making opportunities. We recommended service users be involved throughout the life of a trial, including planning and development, data collection, analysis and dissemination, and listed tasks for collaboration. We listed people responsible for involving service users in studies and promoting an inclusive culture. We advocate actively involving service users as early as possible in the research process, with a minimum of two on all formal trial groups and committees. We propose that researchers protect at least 1% of their total research budget as a minimum resource to involve service users and allow enough time to facilitate active involvement. Conclusions This SOP provides guidance to researchers to involve service users successfully in developing and conducting clinical trials and creating a culture of actively involving service users in research at all stages. The UK Clinical Research Collaboration should encourage clinical trials units actively to involve service users and research funders should provide sufficient funds and time for this in research grants. PMID:23866730

From the Editor: An Introduction to the JSLHR Supplement on Implementation Science.

PubMed

Paul, Rhea

2015-12-01

The JSLHR Supplement on Implementation Science is aimed at providing discussion and examples of research in implementation science, the study of methods designed to promote the incorporation of research findings into clinical practice. Practitioners in the language science area were invited to submit articles that address their experience with various aspects of implementation science. Six articles from several research groups comprise this supplement. Implementation science is an aspect of intervention research that merits consideration by communication disorders scientists. More extensive practice of implementation science will improve uptake of evidence-based practice in the clinical community.

76 FR 25700 - National Center for Research Resources; Notice of Closed Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2011-05-05

... Review Group, Comparative Medicine Review Committee. Date: June 7-8, 2011. Time: 8 a.m. to 12 p.m. Agenda... Assistance Program Nos. 93.306, Comparative Medicine; 93.333, Clinical Research; 93.371, Biomedical...

75 FR 26760 - National Center for Research Resources; Notice of Closed Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2010-05-12

... Review Group; Comparative Medicine Review Committee CMRC 2. Date: June 2, 2010. Time: 8 a.m. to 5 p.m... Domestic Assistance Program Nos. 93.306, Comparative Medicine; 93.333, Clinical Research; 93.371...

Publishing descriptions of non-public clinical datasets: proposed guidance for researchers, repositories, editors and funding organisations.

PubMed

Hrynaszkiewicz, Iain; Khodiyar, Varsha; Hufton, Andrew L; Sansone, Susanna-Assunta

2016-01-01

Sharing of experimental clinical research data usually happens between individuals or research groups rather than via public repositories, in part due to the need to protect research participant privacy. This approach to data sharing makes it difficult to connect journal articles with their underlying datasets and is often insufficient for ensuring access to data in the long term. Voluntary data sharing services such as the Yale Open Data Access (YODA) and Clinical Study Data Request (CSDR) projects have increased accessibility to clinical datasets for secondary uses while protecting patient privacy and the legitimacy of secondary analyses but these resources are generally disconnected from journal articles-where researchers typically search for reliable information to inform future research. New scholarly journal and article types dedicated to increasing accessibility of research data have emerged in recent years and, in general, journals are developing stronger links with data repositories. There is a need for increased collaboration between journals, data repositories, researchers, funders, and voluntary data sharing services to increase the visibility and reliability of clinical research. Using the journal Scientific Data as a case study, we propose and show examples of changes to the format and peer-review process for journal articles to more robustly link them to data that are only available on request. We also propose additional features for data repositories to better accommodate non-public clinical datasets, including Data Use Agreements (DUAs).

Ethics of Mandatory Research Biopsy for Correlative End Points Within Clinical Trials in Oncology

PubMed Central

Peppercorn, Jeffrey; Shapira, Iuliana; Collyar, Deborah; Deshields, Teresa; Lin, Nancy; Krop, Ian; Grunwald, Hans; Friedman, Paula; Partridge, Ann H.; Schilsky, Richard L.; Bertagnolli, Monica M.

2010-01-01

Clinical investigators in oncology are increasingly interested in using molecular analysis of cancer tissue to understand the biologic bases of response or resistance to novel interventions and to develop prognostic and predictive biomarkers that will guide clinical decision making. Some scientific questions of this nature can only be addressed, or may best be addressed, through the conduct of a clinical trial in which research biopsies are obtained from all participants. However, trial designs with mandatory research biopsies have raised ethical concerns related to the risk of harm to participants, the adequacy of voluntary informed consent, and the potential for misunderstanding among research participants when access to an experimental intervention is linked to the requirement to undergo a research biopsy. In consideration of the ethical and scientific issues at stake in this debate, the Cancer and Leukemia Group B Ethics Committee proposes guidelines for clinical trials involving mandatory research biopsies. Any cancer clinical trial that requires research biopsies of participants must be well designed to address the scientific question, obtain the biopsy in a way that minimizes risk, and ensure that research participants are fully informed of the risks, rationale, and requirements of the study, as well as of treatment alternatives. Further guidelines and discussions of this issue are specified in this position paper. We feel that if these principles are respected, an informed adult with cancer can both understand and voluntarily consent to participation in a clinical trial involving mandatory research biopsy for scientific end points. PMID:20406927

The Utrecht approach to exercise in chronic childhood conditions: the decade in review.

PubMed

van Brussel, Marco; van der Net, Janjaap; Hulzebos, Erik; Helders, Paul J M; Takken, Tim

2011-01-01

To summarize and discuss current evidence and understanding of clinical pediatric exercise physiology focusing on the work the research group at Utrecht and others have performed in the last decade in a variety of chronic childhood conditions as a continuation of the legacy of Dr Bar-Or. The report discusses current research findings on the cardiopulmonary exercise performance of children (and adolescents) with juvenile idiopathic arthritis, osteogenesis imperfecta, achondroplasia, hemophilia, cerebral palsy, spina bifida, cystic fibrosis, and childhood cancer. Exercise recommendations and contraindications are provided for each condition. Implications for clinical practice and future research in this area are discussed for each of the chronic conditions presented. The authors provide a basic framework for developing an individual and/or disease-specific training program, introduce the physical activity pyramid, and recommend a core set of clinical measures to be used in clinical research.

A Qualitative Study of Motivations for Minority Recruitment in Cancer Clinical Trials Across Five NCI-Designated Cancer Centers.

PubMed

Simoni, Zachary R; Martin, Michelle; Wenzel, Jennifer A; Cook, Elise D; Konety, Badrinath; Vickers, Selwyn M; Chen, Moon S; Foaud, Mona N; Durant, Raegan W

2016-11-08

Minority enrollment in cancer clinical trials is traditionally low. In light of this fact, numerous studies have investigated barriers to recruitment and retention within minority populations. However, very little research has investigated the importance of clinicians' and researchers' motivations for minority recruitment in cancer clinical trials. Therefore, we sought to examine motivations for minority recruitment across four professional stakeholder groups (principal investigators, clinicians, research staff, and Cancer Center leaders) at five National Cancer Institute (NCI)-designated Comprehensive Cancer Centers. This study is based on the data from 91 qualitative interviews conducted across the five NCI-designated Comprehensive Cancer Centers to investigate stakeholders' motivations for minority recruitment in cancer clinical trials. Emergent themes include (a) minority recruitment increases generalizability of cancer clinical trials, (b) minority recruitment is motivated by social justice, (c) some institutions promote minority recruitment through the use of supplemental financial support, (d) federal funding requirements for minority inclusion in clinical research motivate investigators to focus on minority recruitment, and (e) some stakeholders favor a more race-neutral approach to participant recruitment rather than an emphasis on targeted minority recruitment. The perspectives of clinical and research stakeholders potentially inform the assessment of existing strategies and the development of new strategies to increase motivation for minority recruitment in cancer clinical trials.

Innovation in organ transplantation: A meeting report.

PubMed

Fishman, Jay A; Greenwald, Melissa

2018-05-09

This workshop targeted opportunities to stimulate transformative innovation in organ transplantation. Participants reached consensus regarding the following: (1) Mechanisms are needed to improve the coordination of policy and oversight activities, given overlapping responsibilities for transplantation and clinical investigation among federal agencies. Innovative clinical trials span traditional administrative boundaries and include stakeholders with diverse interests. Participants identified the need for a governmental interagency working group to coordinate nationwide transplant-related activities. (2) Improvements are required in clinical metrics for transplantation, with alignment of performance goals across transplantation organizations and any development of data requirements being consistent with those goals. Database coordination among clinical centers, organ procurement organizations, regulatory agencies, and payers would facilitate research and better inform policy. New data requirements should provide actionable insights into clinical performance. (3) Innovative research seen as potentially adversely affecting Program-Specific Reports may reduce centers' participation. Cutting-edge research requires mitigation of risk-aversive behaviors created by reporting of clinical outcomes data. Participants proposed a new review process in advance of implementation of clinical trials to guide "carve-outs" of transplant center outcomes data from Program-Specific Reports. Clinical transplantation will be advanced by the development of a shared and comprehensive research agenda to facilitate coordination of research and policy. © 2018 The American Society of Transplantation and the American Society of Transplant Surgeons.

Effects of Clinical Pilates Exercises on Patients Developing Lymphedema after Breast Cancer Treatment: A Randomized Clinical Trial.

PubMed

Şener, Hülya Özlem; Malkoç, Mehtap; Ergin, Gülbin; Karadibak, Didem; Yavuzşen, Tuğba

2017-01-01

The aim of the present study was to compare the effects of clinical Pilates exercises with those of the standard lymphedema exercises on lymphedema developing after breast cancer treatment. The study comprised 60 female patients with a mean age of 53.2±7.7 years who developed lymphedema after having breast cancer treatment. The patients were randomized into two groups: the clinical Pilates exercise group (n=30), and the control group (n=30). Before, and at the 8th week of treatment, the following parameters were measured: the severity of lymphedema, limb circumferences, body image using the Social Appearance Anxiety Scale, quality of life with the European Organization for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ-BR23), and upper extremity function using the Disabilities of the Arm, Shoulder and Hand (DASH) outcome measure. Both groups performed one-hour exercises three days a week for 8 weeks. After treatment, the symptoms recovered significantly in both groups. Reductions in the severity of lymphedema, improvements in the social appearance anxiety scale scores, quality of life scores, and upper extremity functions scores in the clinical Pilates exercise group were greater than those in the control group. Clinical Pilates exercises were determined to be more effective on the symptoms of patients with lymphedema than were standard lymphedema exercises. Clinical Pilates exercises could be considered a safe model and would contribute to treatment programs.

Effects of Clinical Pilates Exercises on Patients Developing Lymphedema after Breast Cancer Treatment: A Randomized Clinical Trial

PubMed Central

Şener, Hülya Özlem; Malkoç, Mehtap; Ergin, Gülbin; Karadibak, Didem; Yavuzşen, Tuğba

2017-01-01

Objective The aim of the present study was to compare the effects of clinical Pilates exercises with those of the standard lymphedema exercises on lymphedema developing after breast cancer treatment. Materials and Methods The study comprised 60 female patients with a mean age of 53.2±7.7 years who developed lymphedema after having breast cancer treatment. The patients were randomized into two groups: the clinical Pilates exercise group (n=30), and the control group (n=30). Before, and at the 8th week of treatment, the following parameters were measured: the severity of lymphedema, limb circumferences, body image using the Social Appearance Anxiety Scale, quality of life with the European Organization for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ-BR23), and upper extremity function using the Disabilities of the Arm, Shoulder and Hand (DASH) outcome measure. Both groups performed one-hour exercises three days a week for 8 weeks. Results After treatment, the symptoms recovered significantly in both groups. Reductions in the severity of lymphedema, improvements in the social appearance anxiety scale scores, quality of life scores, and upper extremity functions scores in the clinical Pilates exercise group were greater than those in the control group. Clinical Pilates exercises were determined to be more effective on the symptoms of patients with lymphedema than were standard lymphedema exercises. Conclusions Clinical Pilates exercises could be considered a safe model and would contribute to treatment programs. PMID:28331763

The convergence of personality disorder diagnoses across different methods among monolingual (Spanish-speaking only) Hispanic patients in substance use treatment.

PubMed

Samuel, Douglas B; Añez, Luis M; Paris, Manuel; Grilo, Carlos M

2014-04-01

Methods for diagnosing personality disorders (PDs) within clinical settings typically diverge from those used in treatment research. Treatment groups in research studies are routinely diagnosed using semistructured interviews or self-report questionnaires, yet these methods show poor agreement with clinical diagnoses recorded in medical charts or assigned by treating clinicians, reducing the potential for evidence-based practice. Furthermore, existing research has been limited by focusing on primarily White and English-speaking participants. Our study extended prior research by comparing 4 independent methods of PD diagnosis, including self-report questionnaire, semistructured interview, chart diagnoses, and ratings by treating clinicians, within a clinical series of 130 monolingual (Spanish only) Hispanic persons (69% male; M age 37.4), in treatment for substance use. The authors examined the convergence of the Diagnostic and Statistical Manual of Mental Disorders (4th ed.; DSM-IV) PD diagnoses across these methods. PD diagnoses appeared infrequently within medical charts but were diagnosed at higher levels by independent treating clinicians, self-report questionnaires, and semistructured interviews. Nonetheless, diagnostic concordance between clinical diagnoses and the other methods were poor (κ < .20). Convergence of PD diagnoses across diagnostic methods for Spanish-speaking Hispanic persons are comparable to other groups allaying concerns about cross-cultural application of PD diagnoses. Additionally, the results of this study echo previous research in suggesting that clinicians' PD diagnoses overlap little with self-report questionnaires or semistructured diagnostic interviews and suggest that PDs are underdiagnosed using standard diagnostic approaches. Implications for the clinical application of empirically supported research are discussed. PsycINFO Database Record (c) 2014 APA, all rights reserved

Invited review: study design considerations for clinical research in veterinary radiology and radiation oncology.

PubMed

Scrivani, Peter V; Erb, Hollis N

2013-01-01

High quality clinical research is essential for advancing knowledge in the areas of veterinary radiology and radiation oncology. Types of clinical research studies may include experimental studies, method-comparison studies, and patient-based studies. Experimental studies explore issues relative to pathophysiology, patient safety, and treatment efficacy. Method-comparison studies evaluate agreement between techniques or between observers. Patient-based studies investigate naturally acquired disease and focus on questions asked in clinical practice that relate to individuals or populations (e.g., risk, accuracy, or prognosis). Careful preplanning and study design are essential in order to achieve valid results. A key point to planning studies is ensuring that the design is tailored to the study objectives. Good design includes a comprehensive literature review, asking suitable questions, selecting the proper sample population, collecting the appropriate data, performing the correct statistical analyses, and drawing conclusions supported by the available evidence. Most study designs are classified by whether they are experimental or observational, longitudinal or cross-sectional, and prospective or retrospective. Additional features (e.g., controlled, randomized, or blinded) may be described that address bias. Two related challenging aspects of study design are defining an important research question and selecting an appropriate sample population. The sample population should represent the target population as much as possible. Furthermore, when comparing groups, it is important that the groups are as alike to each other as possible except for the variables of interest. Medical images are well suited for clinical research because imaging signs are categorical or numerical variables that might be predictors or outcomes of diseases or treatments. © 2013 Veterinary Radiology & Ultrasound.

A comparison of Chevron and Lindgren-Turan osteotomy techniques in hallux valgus surgery: a prospective randomized controlled study.

PubMed

Uygur, Esat; Özkan, Namık Kemal; Akan, Kaya; Çift, Hakan

2016-01-01

The aim of this prospective randomized controlled single-blind study was to compare the results of Chevron and Lindgren-Turan osteotomy techniques for treatment of moderate hallux valgus. A total of 66 female patients (34 in Chevron group, 32 Lindgren-Turan group) were recruited in this study and followed up for an average of 26.08 months. Operative procedures were performed by 2 surgeons, and patients were evaluated by an another researcher who was blinded to the surgical technique. The groups were compared for their radiological and clinical results. Both techniques was clinically and radiologically effective (p<0.01). However, no significant differences were found between the 2 groups regarding American Orthopaedic Foot and Ankle Society's clinical rating system, Painful Foot Evaluation scale of Maryland University scores, or radiologic evaluation (p>0.05). Compared to the Chevron group, the Lindgren-Turan group was found to have shorter surgical duration (p<0.05) and significantly more shortening at the first metatarsal (p<0.05). In moderate hallux valgus deformity, both the Chevron and Lindgren-Turan osteotomy techniques are clinically and radiologically safe, effective, and reliable alternatives. No superiority was detected in either technique. Although shortening at the first metatarsal in the Lindgren-Turan group was radiologically significant, the results were clinically tolerable.

WORK SITE CLINICAL AND NEUROBEHAVIORAL ASSESSMENT OF SOLVENT EXPOSED MICROELECTRONICS WORKERS

EPA Science Inventory

A group of 25 workers currently (5), or formerly (20), involved in the manufacture of hybrid microcircuits underwent clinical evaluations at the request of a management-union committee concerned about chronic solvent exposures in a research and development laboratory. attery of n...

Cocaine Use among the College Age Group: Biological and Psychological Effects--Clinical and Laboratory Research Findings.

ERIC Educational Resources Information Center

Nicholi, Armand M., Jr.

1984-01-01

Knowledge about cocaine's effect on the human mind and body is limited and not clearly documented. This article discusses various biological and psychological effects of the drug based on clinical and laboratory studies of man. (Author/DF)

Foresight scanning: future directions of clinical and pharmaceutical research.

PubMed

Foster, Brian C

2008-01-01

Foresight Scanning: Future Directions of Clinical and Pharmaceutical Research. Brian C. Foster, Therapeutic Products Directorate, Health Canada, Ottawa, Ontario, Canada ABSTRACT The Canadian Society for Pharmaceutical Sciences Satellite Symposium on Foresight Scanning, May 26 and 27, 2008, Nordegg, Alberta, Canada, focussed on the future directions of clinical and pharmaceutical research. The symposium brought together a group of clinicians, regulatory scientists, researchers and students to examine where clinical, pharmaceutical, and regulatory science might be in 10 to 15 years. Industry, regulatory, analytical, and clinical perspectives were presented and discussed, as well as the impact of exogenous (indirect) and endogenous (direct) change drivers. Unconditional funding was provided by Bayer HealthCare; they had no input on the direction of the meeting or selection of speakers. It was envisioned that the more important endogenous drivers may not be new information or changes in technology, policy, regulation, or health care delivery, but amplification of long-term underlying trends by emergence of new technologies, convergence of existing technologies or new communication and collaboration vehicles such as Web 2.0.

Defining Responses to Therapy and Study Outcomes in Clinical Trials of Invasive Fungal Diseases: Mycoses Study Group and European Organization for Research and Treatment of Cancer Consensus Criteria

PubMed Central

Segal, Brahm H.; Herbrecht, Raoul; Stevens, David A.; Ostrosky-Zeichner, Luis; Sobel, Jack; Viscoli, Claudio; Walsh, Thomas J.; Maertens, Johan; Patterson, Thomas F.; Perfect, John R.; Dupont, Bertrand; Wingard, John R.; Calandra, Thierry; Kauffman, Carol A.; Graybill, John R.; Baden, Lindsey R.; Pappas, Peter G.; Bennett, John E.; Kontoyiannis, Dimitrios P.; Cordonnier, Catherine; Viviani, Maria Anna; Bille, Jacques; Almyroudis, Nikolaos G.; Wheat, L. Joseph; Graninger, Wolfgang; Bow, Eric J.; Holland, Steven M.; Kullberg, Bart-Jan; Dismukes, William E.; De Pauw, Ben E.

2009-01-01

Invasive fungal diseases (IFDs) have become major causes of morbidity and mortality among highly immunocompromised patients. Authoritative consensus criteria to diagnose IFD have been useful in establishing eligibility criteria for antifungal trials. There is an important need for generation of consensus definitions of outcomes of IFD that will form a standard for evaluating treatment success and failure in clinical trials. Therefore, an expert international panel consisting of the Mycoses Study Group and the European Organization for Research and Treatment of Cancer was convened to propose guidelines for assessing treatment responses in clinical trials of IFDs and for defining study outcomes. Major fungal diseases that are discussed include invasive disease due to Candida species, Aspergillus species and other molds, Cryptococcus neoformans, Histoplasma capsulatum, and Coccidioides immitis. We also discuss potential pitfalls in assessing outcome, such as conflicting clinical, radiological, and/or mycological data and gaps in knowledge. PMID:18637757

Points to consider: efficacy and safety evaluations in the clinical development of ultra-orphan drugs.

PubMed

Maeda, Kojiro; Kaneko, Masayuki; Narukawa, Mamoru; Arato, Teruyo

2017-08-23

The unmet medical needs of individuals with very rare diseases are high. The clinical trial designs and evaluation methods used for 'regular' drugs are not applicable in the clinical development of ultra-orphan drugs (<1000 patients) in many cases. In order to improve the clinical development of ultra-orphan drugs, we examined several points regarding the efficient evaluations of drug efficacy and safety that could be conducted even with very small sample sizes, based on the review reports of orphan drugs approved in Japan. The clinical data packages of 43 ultra-orphan drugs approved in Japan from January 2001 to December 2014 were investigated. Japanese clinical trial data were not included in the clinical data package for eight ultra-orphan drugs, and non-Japanese clinical trial data were included for six of these eight drug. Japanese supportive data that included retrospective studies, published literature, clinical research and Japanese survey results were clinical data package attachments in 22 of the 43 ultra-orphan drugs. Multinational trials were conducted for three ultra-orphan drugs. More than two randomized controlled trials (RCTs) were conducted for only 11 of the 43 ultra-orphan drugs. The smaller the number of patients, the greater the proportion of forced titration and optional titration trials were conducted. Extension trials were carried out for enzyme preparations and monoclonal antibodies with high ratio. Post-marketing surveillance of all patients was required in 36 of the 43 ultra-orphan drugs. For ultra-orphan drugs, clinical endpoints were used as the primary efficacy endpoint of the pivotal trial only for two drugs. The control groups in RCTs were classified as follows: placebo groups different dosage groups, and active controls groups. Sample sizes have been determined on the basis of feasibility for some ultra-orphan drugs. We provide "Draft Guidance on the Clinical Development of Ultra-Orphan Drugs" based on this research. The development of ultra-orphan drugs requires various arrangements regarding evidence collection, data sources and the clinical trial design. We expect that this draft guidance is useful for ultra-orphan drugs developments in future.

A clinical investigation of motivation to change standards and cognitions about failure in perfectionism.

PubMed

Egan, Sarah J; Piek, Jan P; Dyck, Murray J; Rees, Clare S; Hagger, Martin S

2013-10-01

Clinical perfectionism is a transdiagnostic process that has been found to maintain eating disorders, anxiety disorders and depression. Cognitive behavioural models explaining the maintenance of clinical perfectionism emphasize the contribution of dichotomous thinking and resetting standards higher following both success and failure in meeting their goals. There has been a paucity of research examining the predictions of the models and motivation to change perfectionism. Motivation to change is important as individuals with clinical perfectionism often report many perceived benefits of their perfectionism; they are, therefore, likely to be ambivalent regarding changing perfectionism. The aim was to compare qualitative responses regarding questions about motivation to change standards and cognitions regarding failure to meet a personal standard in two contrasting groups with high and low negative perfectionism. Negative perfectionism refers to concern over not meeting personal standards. A clinical group with a range of axis 1 diagnoses who were elevated on negative perfectionism were compared to a group of athletes who were low on negative perfectionism. Results indicated that the clinical group perceived many negative consequences of their perfectionism. They also, however, reported numerous benefits and the majority stated that they would prefer not to change their perfectionism. The clinical group also reported dichotomous thinking and preferring to either keep standards the same or reset standards higher following failure, whilst the athlete group reported they would keep standards the same or set them lower. The findings support predictions of the cognitive behavioural model of clinical perfectionism.

Female arsonists: key features, psychopathologies, and treatment needs.

PubMed

Gannon, Theresa A

2010-01-01

Female-perpetrated arson is a topic that has received relatively little research attention from either psychiatrists or psychologists. In this review, available research regarding the characteristics, psychopathologies, and current treatment efforts with female arsonists is reviewed. Evaluation of current research with female arsonists suggests that very few researchers have compared female arsonists either to suitable female offender control groups or male arsons. Consequently, clinical knowledge and practice regarding female-perpetrated arson is underdeveloped relative to both other areas of forensic-clinical psychiatry and to knowledge of male arsonists. Suggestions are made for translating current research into arson interventions with female arsonists. Core arenas for future treatment and research provision are also highlighted.

Participation in Clinical Research Registries: A Focus Group Study Examining Views From Patients With Arthritis and Other Chronic Illnesses.

PubMed

Lee, Sara B; Zak, Agnes; Iversen, Maura D; Polletta, Valerie L; Shadick, Nancy A; Solomon, Daniel H

2016-07-01

Patient registries have contributed substantially to progress in clinical research in rheumatic diseases. However, not much is known about how to optimize the patient experience in such registries. We assessed patient views, motivations, and potential barriers towards participation in registry research to better understand how registries can be improved to maximize patient engagement. Focus groups were held with 23 patients (mean ± SD age 59 ± 13 years) from the Boston area and led by a bilingual moderator trained in focus group methodology, using a semistructured moderator guide. Three separate focus groups were conducted to thematic saturation: patients with rheumatoid arthritis (RA) who had registry experience, patients with any chronic illness, and Spanish-speaking patients with RA or osteoarthritis. Patients in the latter 2 groups had no prior registry experience. Focus groups were audiotaped and transcribed. Four researchers independently analyzed transcripts using open data coding to identify themes. A normative group process was used to consolidate and refine themes. Seven major themes were identified, including personalization/convenience of data collection, trust and confidentiality, camaraderie, learning about yourself and your disease, altruism, material motivators, and capturing mental health and other elements of the lived experience. We observed distinct differences in the discussion content of the Spanish-speaking patients compared to the English-speaking patients. This study identified patient attitudes towards registry research among those with and without prior experience in a registry. The results provide insight into strategies for registry design to maximize patient engagement, which can lead to more robust registry data. © 2016, American College of Rheumatology.

Feasibility trial of a Spanish-language multimedia educational intervention.

PubMed

Wells, Kristen J; McIntyre, Jessica; Gonzalez, Luis E; Lee, Ji-Hyun; Fisher, Kate J; Jacobsen, Paul B; Meade, Cathy; Muñoz-Antonia, Teresita; Quinn, Gwendolyn P

2013-10-01

Hispanic cancer patients are underrepresented in clinical trials; research suggests lack of knowledge and language barriers contribute to low accrual. Multimedia materials offer advantages to Hispanic populations because they have high acceptability, are easy to disseminate, and can be viewed with family. Hispanic cancer patients and caregivers participated in focus groups to aid in developing a Spanish-language multimedia intervention to educate Hispanic cancer patients about clinical trials. We explored the feasibility of delivering the intervention in medical oncology clinics. A total of 35 patients were randomized to either the multimedia intervention group (n = 18) or a control group (n = 17) who were asked to read the National Cancer Institute's Spanish-language clinical trials brochure. Self-reported data on knowledge about and attitudes toward clinical trials, self-efficacy for participating in a clinical trial, intention to participate in a clinical trial if asked, and receptivity to information about a clinical trial were collected at baseline and 10 days later. Delivery of the multimedia presentation in oncology clinics was feasible. The intervention group had more knowledge about clinical trials at follow-up than the control group; scores for intention to participate in a clinical trial by participants in the intervention group increased from 3.8 to 4.0 of a possible 5, but declined in the control group from 4.5 to 4.1. No statistically significant difference was detected between groups in scores for attitudes or self-efficacy for making a decision to participate in a clinical trial. Our sample size was inadequate to identify differences between the informational methods. Although all patients were asked about their willingness to participate in a clinical trial, this decision was hypothetical. In addition, the study was conducted with a sample of Spanish-speaking Hispanic cancer patients at a comprehensive cancer center in Florida. Thus, the results may not generalize to other Hispanic populations. In the pilot project, we demonstrated the feasibility of delivering multimedia information to patients in medical oncology clinics. Because delivery in a clinical setting was found to be feasible, a larger study should be conducted to evaluate the efficacy of the multimedia intervention with respect to promoting accrual of Hispanic patients to clinical trials.

EVALUATION OF THE ANTIGENICITY AND IMMUNOGENICITY OF Eimeria tenella BY REPRODUCTIVE INDEX AND HISTOPATHOLOGICAL CHANGES OF CECAL COCCIDIOSIS VIRULENT LIVE VACCINE IN BROILER CHICKENS

PubMed Central

Suprihati, Endang; Yunus, Muchammad

2018-01-01

Background: The development of vaccine to control coccidiosis caused by Eimeria tenella (E. tenella) in chickens is intensifying because of the increasing threat of drug resistance to anticoccidial agents. It is important, therefore, to develop a reliable standard method for the assessment of vaccine afficacy particularly antigenicity and immunogenicity become crucial. Evaluation of E. tenella antigenicity and immunogenicity to some low doses can be reflected by reproductive index and histopathological changes. Materials and Methods: The complete random design of research was used in this study. Sixty of two weeks old broilers were divided into four groups and each group composed 15 replications. The group 1 was chicken group without virulent E. tenella oocyst inoculation. The group 2, 3 and group 4 were chicken group inoculated with virulent E. tenella oocyst at doses of 1.0 x 102, 2.0 x 102, 3.0 x 102, respectively. Then all chicken groups were challenged with E. tenella oocyst at doses of 1.0 x 103. Observation of research that represented antigenicity and immunogenicity was clinical sign, reproductive index, histopathological changes. Results: On virulent E. tenella inoculation step, some clinical signs such as appetite, weakness, and diarrhea were very slight on all chicken groups. While on challenge test step, there were no clinical signs of all chicken groups except the group 1. For the reproductive index of virulent E. tenella inoculation step, there were no significantly differences in all chicken groups except the group 1. As reproductive index, the same result pattern was seen for histopathological changes. Conclusion: The low number virulent E. tenella had low reproductive index and few histopathological changes effect that represents a promising strategy to prevent cecal coccidiosis in chickens. PMID:29619439

EVALUATION OF THE ANTIGENICITY AND IMMUNOGENICITY OF Eimeria tenella BY REPRODUCTIVE INDEX AND HISTOPATHOLOGICAL CHANGES OF CECAL COCCIDIOSIS VIRULENT LIVE VACCINE IN BROILER CHICKENS.

PubMed

Suprihati, Endang; Yunus, Muchammad

2018-01-01

The development of vaccine to control coccidiosis caused by Eimeria tenella ( E. tenella ) in chickens is intensifying because of the increasing threat of drug resistance to anticoccidial agents. It is important, therefore, to develop a reliable standard method for the assessment of vaccine afficacy particularly antigenicity and immunogenicity become crucial. Evaluation of E. tenella antigenicity and immunogenicity to some low doses can be reflected by reproductive index and histopathological changes. The complete random design of research was used in this study. Sixty of two weeks old broilers were divided into four groups and each group composed 15 replications. The group 1 was chicken group without virulent E. tenella oocyst inoculation. The group 2, 3 and group 4 were chicken group inoculated with virulent E. tenella oocyst at doses of 1.0 x 10 2 , 2.0 x 10 2 , 3.0 x 10 2 , respectively. Then all chicken groups were challenged with E. tenella oocyst at doses of 1.0 x 10 3 . Observation of research that represented antigenicity and immunogenicity was clinical sign, reproductive index, histopathological changes. On virulent E. tenella inoculation step, some clinical signs such as appetite, weakness, and diarrhea were very slight on all chicken groups. While on challenge test step, there were no clinical signs of all chicken groups except the group 1. For the reproductive index of virulent E. tenella inoculation step, there were no significantly differences in all chicken groups except the group 1. As reproductive index, the same result pattern was seen for histopathological changes. The low number virulent E. tenella had low reproductive index and few histopathological changes effect that represents a promising strategy to prevent cecal coccidiosis in chickens.

2014 Section on Pediatrics Knowledge translation Lecture: Clinicians and researchers on the same path toward facilitating family goals for mobility & participation

PubMed Central

Damiano, Diane L.; Leonard, Rebecca

2015-01-01

BACKGROUND The Knowledge Translation (KT) Lecture at CSM 2014 was a personal perspective from a researcher who had been a therapist and a longtime clinician, now a Ph.D. candidate. OBJECTIVE To better integrate research and clinical care, so KT is a seamless rather than separate process. KEY POINTS KT can be enhanced by improved receptivity to evidence, and increasing use of research designs that encourage and even require clinician involvement, from single-subject designs to large-scale pragmatic trials. Clinical practice databases and hiring therapists to provide intervention in research efforts also serve to integrate research and clinical care. Limitations of applying mean group research results to an individual patient were also discussed and suggest an important unanswered topic for future research. CONCLUSION We all need to assume responsibility for the researcher-clinician partnership, making our jobs more joyful and fulfilling, and hopefully the biggest beneficiaries will be our current and future patients. PMID:25822350

2014 section on pediatrics knowledge translation lecture: clinicians and researchers on the same path toward facilitating family goals for mobility and participation.

PubMed

Damiano, Diane L; Leonard, Rebecca

2015-01-01

The knowledge translation (KT) lecture at the Combined Sections Meeting 2014 was a personal perspective from a researcher who had been a therapist and a longtime clinician, now a PhD candidate. To better integrate research and clinical care, KT is a seamless rather than separate process. Knowledge translation can be enhanced by improved receptivity to evidence, and increasing use of research designs that encourage and even require clinician involvement, from single-subject designs to large-scale pragmatic trials. Clinical practice databases and hiring therapists to provide intervention in research efforts also serve to integrate research and clinical care. Limitations of applying mean group research results to an individual patient were also discussed and suggest an important unanswered topic for future research. We all need to assume responsibility for the researcher-clinician partnership, making our jobs more joyful and fulfilling, and hopefully the biggest beneficiaries will be our current and future patients.

Improving communication when seeking informed consent: a randomised controlled study of a computer-based method for providing information to prospective clinical trial participants.

PubMed

Karunaratne, Asuntha S; Korenman, Stanley G; Thomas, Samantha L; Myles, Paul S; Komesaroff, Paul A

2010-04-05

To assess the efficacy, with respect to participant understanding of information, of a computer-based approach to communication about complex, technical issues that commonly arise when seeking informed consent for clinical research trials. An open, randomised controlled study of 60 patients with diabetes mellitus, aged 27-70 years, recruited between August 2006 and October 2007 from the Department of Diabetes and Endocrinology at the Alfred Hospital and Baker IDI Heart and Diabetes Institute, Melbourne. Participants were asked to read information about a mock study via a computer-based presentation (n = 30) or a conventional paper-based information statement (n = 30). The computer-based presentation contained visual aids, including diagrams, video, hyperlinks and quiz pages. Understanding of information as assessed by quantitative and qualitative means. Assessment scores used to measure level of understanding were significantly higher in the group that completed the computer-based task than the group that completed the paper-based task (82% v 73%; P = 0.005). More participants in the group that completed the computer-based task expressed interest in taking part in the mock study (23 v 17 participants; P = 0.01). Most participants from both groups preferred the idea of a computer-based presentation to the paper-based statement (21 in the computer-based task group, 18 in the paper-based task group). A computer-based method of providing information may help overcome existing deficiencies in communication about clinical research, and may reduce costs and improve efficiency in recruiting participants for clinical trials.

Perceived social stress and symptom severity among help-seeking adolescents with versus without clinical high-risk for psychosis.

PubMed

Millman, Zachary B; Pitts, Steven C; Thompson, Elizabeth; Kline, Emily R; Demro, Caroline; Weintraub, Marc J; DeVylder, Jordan E; Mittal, Vijay A; Reeves, Gloria M; Schiffman, Jason

2018-02-01

Research suggests that social stress exposure influences illness presentation and course among youth at clinical high-risk (CHR) for psychosis, though less is known about the extent to which self-reported perceptions of social stress relate to the severity of positive symptoms. Importantly, despite the notion that youth at CHR are especially susceptible to elevations in positive symptoms under conditions of stress, no study has examined this presumption relative to other psychiatric groups. Extending previous work demonstrating that perceived social stress was higher in a CHR group than in a clinical group of non-CHR, help-seeking controls, the current study aimed to: (1) examine whether perceived social stress is related to the severity of attenuated positive symptoms in the full sample (N=110); and (2) determine whether CHR status moderates the stress-symptom relation. Exploratory analyses examined relations of perceived social stress to negative, disorganized, and general symptoms. Greater perceptions of social stress were associated with more severe positive symptoms in the entire sample; however, although positive symptoms and perceived social stress were higher in the CHR group, the strength of this relation was statistically indistinguishable across groups. No differential effect of perceived social stress was observed for any symptom domain. Results provide some support for the diathesis-stress model of psychosis, while also suggesting that social stress and symptomatology are related independent of clinical vulnerability to psychosis. Future research would benefit from longitudinal studies of stress-symptom relations across CHR and help-seeking control groups. Copyright © 2017 Elsevier B.V. All rights reserved.

Clinical research in implant dentistry: study design, reporting and outcome measurements: consensus report of Working Group 2 of the VIII European Workshop on Periodontology.

PubMed

Tonetti, Maurizio; Palmer, Richard

2012-02-01

The objective of this working group was to assess and make specific recommendations to improve the quality of reporting of clinical research in implant dentistry and discuss ways to reach a consensus on choice of outcomes. Discussions were informed by three systematic reviews on quality of reporting of observational studies (case series, case-control and cohort) and experimental research (randomized clinical trials). An additional systematic review provided information on choice of outcomes and analytical methods. In addition, an open survey among all workshop participants was utilized to capture a consensus view on the limits of currently used survival and success-based outcomes as well as to identify domains that need to be captured by future outcome systems. The Workshop attempted to clarify the characteristics and the value in dental implant research of different study designs. In most areas, measurable quality improvements over time were identified. The Workshop recognized important aspects that require continued attention by clinical researchers, funding agencies and peer reviewers to decrease potential bias. With regard to choice of outcomes, the limitations of currently used systems were recognized. Three broad outcome domains that need to be captured by future research were identified: (i) patient reported outcome measures, (ii) peri-implant tissue health and (iii) performance of implant supported restorations. Peri-implant tissue health can be measured by marginal bone level changes and soft tissue inflammation and can be incorporated in time to event analyses. The Workshop recommended that collaboration between clinicians and epidemiologists/clinical trials specialists should be encouraged. Aspects of design aimed at limitation of potential bias should receive attention by clinical researchers, funding agencies and journal editors. Adherence to appropriate reporting guidelines such as STROBE and CONSORT are necessary standards. Research on outcome measure domains is an area of top priority and should urgently inform a proper process leading to a consensus on outcome measures in dental implant research. © 2012 John Wiley & Sons A/S.

Looking to a future of improved diabetes management: interview with Professor Steve Bain.

PubMed

Bain, Steve

2016-12-01

Steve Bain talks to Francesca Lake, Managing Editor: Steve is currently a Professor at Swansea University Medical School (Wales), Assistant Medical Director for Research & Development for ABM University Health Board and Clinical Lead for the Diabetes Research Unit, Wales. His clinical training included research into the genetics of Type 1 diabetes, with his current clinical interests surrounding exercise in Type 1 diabetes, new therapies and the provision of diabetes services. His background has led him to be Principal Investigator for several multicenter trials, and to be involved in various ethical committees concerning genetics. He led the UK Human Genetics Commission's report on DNA testing in 2009, and in 2007 was invited to sit on the National DNA Database Ethics Group, established by the Secretary of State for the Home Department. Steve is also a member of the Wales Diabetes & Endocrine Society executive committee and chairs the Specialist Training Committee for Diabetes & Endocrinology for Wales. He also chairs the Board that oversees the Institute of Life Science Joint Clinical Research Facility, the premier clinical research institute in Wales.

Clinical Research Methodology 2: Observational Clinical Research.

PubMed

Sessler, Daniel I; Imrey, Peter B

2015-10-01

Case-control and cohort studies are invaluable research tools and provide the strongest feasible research designs for addressing some questions. Case-control studies usually involve retrospective data collection. Cohort studies can involve retrospective, ambidirectional, or prospective data collection. Observational studies are subject to errors attributable to selection bias, confounding, measurement bias, and reverse causation-in addition to errors of chance. Confounding can be statistically controlled to the extent that potential factors are known and accurately measured, but, in practice, bias and unknown confounders usually remain additional potential sources of error, often of unknown magnitude and clinical impact. Causality-the most clinically useful relation between exposure and outcome-can rarely be definitively determined from observational studies because intentional, controlled manipulations of exposures are not involved. In this article, we review several types of observational clinical research: case series, comparative case-control and cohort studies, and hybrid designs in which case-control analyses are performed on selected members of cohorts. We also discuss the analytic issues that arise when groups to be compared in an observational study, such as patients receiving different therapies, are not comparable in other respects.

Moving forward through consensus: protocol for a modified Delphi approach to determine the top research priorities in the field of orthopaedic oncology.

PubMed

Schneider, Patricia; Evaniew, Nathan; Rendon, Juan Sebastian; McKay, Paula; Randall, R Lor; Turcotte, Robert; Vélez, Roberto; Bhandari, Mohit; Ghert, Michelle

2016-05-24

Orthopaedic oncology researchers face several obstacles in the design and execution of randomised controlled trials, including finite fiscal resources to support the rising costs of clinical research and insufficient patient volume at individual sites. As a result, high-quality research to guide clinical practice has lagged behind other surgical subspecialties. A focused approach is imperative to design a research programme that is economical, streamlined and addresses clinically relevant endpoints. The primary objective of this study will be to use a consensus-based approach to identify research priorities for international clinical trials in orthopaedic oncology. We will conduct a 3-phase modified Delphi method consisting of 2 sequential rounds of anonymous web-based questionnaires (phases I and II), and an in-person consensus meeting (phase III). Participants will suggest research questions that they believe are of particular importance to the field (phase I), and individually rate each proposed question on 5 criteria (phase II). Research questions that meet predetermined consensus thresholds will be brought forward to the consensus meeting (phase III) for discussion by an expert panel. Following these discussions, the expert panel will be asked to assign scores for each research question, and research questions meeting predetermined criteria will be brought forward for final ranking. The expert panel will then be asked to rank the top 3 research questions, and these 3 research questions will be distributed to the initial group of participants for validation. An ethics application is currently under review with the Hamilton Integrated Research Ethics Board in Hamilton, Ontario, Canada. The results of this initiative will be disseminated through peer-reviewed publications and conference presentations. 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/

Worta McCaskill-Stevens, MD, MS | Division of Cancer Prevention

Cancer.gov

Dr. Worta McCaskill-Stevens is a medical oncologist and Chief of the Community Oncology and Prevention Trials Research Group, which houses the NCI Community Oncology Research Program (NCORP), a community-based clinical trials network launched in 2014. |

Thursday's Agenda | Division of Cancer Prevention

Cancer.gov

TimeAgenda8:30 am - 8:50 amRegistration - Networking8:50 am - 8:55 amWelcome and Opening RemarksLeslie Ford, MDAssociate Director for Clinical ResearchDivision of Cancer Prevention, NCIEva Szabo, MD Chief, Lung and Upper Aerodigestive Cancer Research Group |

The effect of an educational intervention, based on clinical simulation, on the diagnosis of rheumatoid arthritis and osteoarthritis.

PubMed

Fernández-Ávila, Daniel G; Ruiz, Álvaro J; Gil, Fabián; Mora, Sergio A; Tobar, Carlos; Gutiérrez, Juan M; Rosselli, Diego

2018-03-01

The aim of the present study was to evaluate the effectiveness of an educational tool for general physicians, based on rheumatological clinical simulation, for the diagnosis of rheumatoid arthritis and osteoarthritis. A randomized clinical study was carried out, in which the physician research subjects were assigned to one of two groups: the experimental group (educational intervention for rheumatoid arthritis with clinical simulation) or the control group (educational intervention for the basic aspects of the diagnosis and treatment of osteoporosis). Four weeks after the educational intervention, the members of both groups completed an examination that included four clinical cases with real patients, two clinical cases with two clinical simulation models and six virtual clinical cases. In this examination, the participants noted clinical findings, established a diagnosis and defined the complementary tests they would request, if necessary, to corroborate their diagnosis. A total of 160 doctors participated (80 in the active educational intervention for rheumatoid arthritis and 80 in the control group), of whom 89 were women (56%). The mean age was 35 (standard deviation 7.7) years. Success was defined as a physician correctly diagnosing at least 10 of the 12 cases presented. A significant difference of 81.3% (95% confidence interval 72-90%; p < 0.001) in success was found in favour of the active group (88.8% versus 7.5%). A greater number of correct answers was found in the active group compared with the control group in the detection of clinical findings and in the number of complementary tests requested (p < 0.001). The study showed the effectiveness of an educational intervention based on clinical simulation to improve the diagnostic approach to rheumatoid arthritis and osteoarthritis. The results open a new horizon in the teaching of rheumatology. Copyright © 2017 John Wiley & Sons, Ltd.

Patient Engagement in Neurological Clinical Trials Design: A Conference Summary.

PubMed

Cobb, Enesha M; Meurer, William; Harney, Deneil; Silbergleit, Robert; Lake, Bray Patrick; Clark, Christina; Gipson, Debbie; Barsan, William

2015-12-01

The conference objectives included educating patients and advocates about clinical trials, educating the clinical research community about patient perspectives on participating in clinical trial design, and identifying strategies to increase participation in clinical trial design for neurological disorders. Observations were noted during a 1-day conference attended by patients, patient advocates, clinical trial staff, and investigators. The conference offered didactic sessions, small, and large group discussions. Conference participants were patients, patient advocates, clinical trial staff, students, and investigators interested in engaging patients in clinical trial design for neurological disorders. Conference participants were asked to consider lessons learned that could increase patient engagement in clinical trial design. We found that there is growing interest in including patients in the design of clinical trials for neurological disorders. Several themes emerged on how to move forward: networking; the multifaceted roles of advocates in research; training and education; creating patient-researcher partnerships; and clinical trials regulation issues. The conference provided a forum for dialogue regarding stakeholder engagement in the design of clinical trials for neurological disorders. This experience provides a template for replication and dissemination of this conference and informs next steps to accelerate the pathway from dialogue to action. © 2015 Wiley Periodicals, Inc.

Assessing clinical researchers' information needs to create responsive portals and tools: my Research Assistant (MyRA) at the University of Utah: a case study.

PubMed

Reich, Margaret; Shipman, Jean P; Narus, Scott P; Weir, Charlene; Madsen, Randy; Schultz, N Dustin; Cameron, Justin M; Adamczyk, Abby L; Mitchell, Joyce A

2013-01-01

How can health sciences librarians and biomedical informaticians offer relevant support to Clinical and Translational Science Award (CTSA) personnel? The Spencer S. Eccles Health Sciences Library and the associate vice president for information technology for the health sciences office at the University of Utah conducted a needs assessment. Faculty and staff from these two units, with the services of a consultant and other CTSA partners, employed a survey, focus groups, interviews, and committee discussions. An information portal was created to meet identified needs. A directive white paper was created. The process employed to plan a virtual and physical collaborative, collegial space for clinical researchers at the university and its three inter-institutional CTSA partners is described. The university's model can assist other librarians and informaticians with how to become part of a CTSA-focused infrastructure for clinical and translational research and serve researchers in general.

Optimizing the use of video-tapes of clinical sessions: the data-mining approach for scale construction and theory building for bereaved persons in Hong Kong.

PubMed

Chow, Amy Yin Man

2010-01-01

Video-taping clinical sessions is a common practice among social workers so that the tapes may be used for clinical supervision and reviewed with the individuals or families involved. They are usually underused for research purposes. This article reports on an innovative research method using such tapes as a basis for clinical data mining to explore the bereavement experience of Chinese people in Hong Kong. Using this data, a rich item pool, containing both negative and positive reactions, was generated to allow the development of a culturally relevant measurement tool of grief reactions. The data also facilitated theory building in the area of grief and bereavement. This study extended the use of video-tapes in clinical sessions for research purposes and helped to collect reliable and timely data in a non-intrusive way. It has also advanced the use of quantitative data in the clinical data-mining approach. The study encouraged collaboration between clinicians and researchers to develop knowledge and skills about their special target group of clients.

[Evaluation of the results of clinical trials using a new non-statistical method].

PubMed

Zofková, I

1994-04-04

The author presents information on the possibilities and some advantages associated with the application of a new nonstatistical (gnostic) method for evaluation of results in clinical trials. The mentioned method is among other properties very robust, i.e. suited for evaluation of small groups of highly scattered data, a situation very frequently encountered in clinical research.

Vitamin E in aging persons with Down syndrome: A randomized, placebo-controlled clinical trial.

PubMed

Sano, Mary; Aisen, Paul S; Andrews, Howard F; Tsai, Wei-Yann; Lai, Florence; Dalton, Arthur J

2016-05-31

To determine whether vitamin E would slow the progression of cognitive deterioration and dementia in aging persons with Down syndrome (DS). A randomized, double-blind controlled clinical trial was conducted at 21 clinical sites, and researchers trained in research procedures recruited adults with DS older than 50 years to participate. Participants were randomly assigned to receive 1,000 IU of vitamin E orally twice daily for 3 years or identical placebo. The primary outcome was change on the Brief Praxis Test (BPT). Secondary outcomes included incident dementia and measures of clinical global change, cognition, function, and behavior. A total of 337 individuals were randomized, 168 to vitamin E and 169 to placebo. Both groups demonstrated deterioration on the BPT with no difference between drug and placebo. At baseline, 26% were diagnosed with dementia and there was an overall rate of incident dementia of 11%/year with no difference between groups. There was no effect on the secondary outcome measures. Though numerically higher in the treatment group, there was no difference in the number of adverse events (p = 0.079) and deaths (p = 0.086) between groups. Vitamin E did not slow the progression of cognitive deterioration in older individuals with DS. This study provides Class II evidence that vitamin E does not significantly slow the progression of cognitive deterioration in aging persons with DS. © 2016 American Academy of Neurology.

An integrated educational model for continuing nurse education.

PubMed

Duff, Beverley; Gardner, Glenn; Osborne, Sonya

2014-01-01

This paper reports on the development and evaluation of an integrated clinical learning model to inform ongoing education for surgical nurses. The research aim was to evaluate the effectiveness of implementing a Respiratory Skills Update (ReSKU) education program, in the context of organisational utility, on improving surgical nurses' practice in the area of respiratory assessment. Continuous development and integration of technological innovations and research in the healthcare environment mandate the need for continuing education for nurses. Despite an increased worldwide emphasis on this, there is scant empirical evidence of program effectiveness. A quasi experimental pre test, post test non-equivalent control group design evaluated the impact of the ReSKU program on surgical nurses' clinical practice. The 2008 study was conducted in a 400 bed regional referral public hospital and was consistent with contemporary educational approaches using multi-modal, interactive teaching strategies. The study demonstrated statistically significant differences between groups regarding reported use of respiratory skills, three months after ReSKU program attendance. Between group data analysis indicated that the intervention group's reported beliefs and attitudes pertaining to subscale descriptors showed statistically significant differences in three of the six subscales. The construct of critical thinking in the clinical context, combined with clinical reasoning and purposeful reflection, was a powerful educational strategy to enhance competency and capability in clinicians. Crown Copyright © 2012. Published by Elsevier Ltd. All rights reserved.

Evaluation of tuberculosis diagnostics in children: 1. Proposed clinical case definitions for classification of intrathoracic tuberculosis disease. Consensus from an expert panel.

PubMed

Graham, Stephen M; Ahmed, Tahmeed; Amanullah, Farhana; Browning, Renee; Cardenas, Vicky; Casenghi, Martina; Cuevas, Luis E; Gale, Marianne; Gie, Robert P; Grzemska, Malgosia; Handelsman, Ed; Hatherill, Mark; Hesseling, Anneke C; Jean-Philippe, Patrick; Kampmann, Beate; Kabra, Sushil Kumar; Lienhardt, Christian; Lighter-Fisher, Jennifer; Madhi, Shabir; Makhene, Mamodikoe; Marais, Ben J; McNeeley, David F; Menzies, Heather; Mitchell, Charles; Modi, Surbhi; Mofenson, Lynne; Musoke, Philippa; Nachman, Sharon; Powell, Clydette; Rigaud, Mona; Rouzier, Vanessa; Starke, Jeffrey R; Swaminathan, Soumya; Wingfield, Claire

2012-05-15

There is a critical need for improved diagnosis of tuberculosis in children, particularly in young children with intrathoracic disease as this represents the most common type of tuberculosis in children and the greatest diagnostic challenge. There is also a need for standardized clinical case definitions for the evaluation of diagnostics in prospective clinical research studies that include children in whom tuberculosis is suspected but not confirmed by culture of Mycobacterium tuberculosis. A panel representing a wide range of expertise and child tuberculosis research experience aimed to develop standardized clinical research case definitions for intrathoracic tuberculosis in children to enable harmonized evaluation of new tuberculosis diagnostic technologies in pediatric populations. Draft definitions and statements were proposed and circulated widely for feedback. An expert panel then considered each of the proposed definitions and statements relating to clinical definitions. Formal group consensus rules were established and consensus was reached for each statement. The definitions presented in this article are intended for use in clinical research to evaluate diagnostic assays and not for individual patient diagnosis or treatment decisions. A complementary article addresses methodological issues to consider for research of diagnostics in children with suspected tuberculosis.

Quality of outpatient clinical notes: a stakeholder definition derived through qualitative research.

PubMed

Hanson, Janice L; Stephens, Mark B; Pangaro, Louis N; Gimbel, Ronald W

2012-11-19

There are no empirically-grounded criteria or tools to define or benchmark the quality of outpatient clinical documentation. Outpatient clinical notes document care, communicate treatment plans and support patient safety, medical education, medico-legal investigations and reimbursement. Accurately describing and assessing quality of clinical documentation is a necessary improvement in an increasingly team-based healthcare delivery system. In this paper we describe the quality of outpatient clinical notes from the perspective of multiple stakeholders. Using purposeful sampling for maximum diversity, we conducted focus groups and individual interviews with clinicians, nursing and ancillary staff, patients, and healthcare administrators at six federal health care facilities between 2009 and 2011. All sessions were audio-recorded, transcribed and qualitatively analyzed using open, axial and selective coding. The 163 participants included 61 clinicians, 52 nurse/ancillary staff, 31 patients and 19 administrative staff. Three organizing themes emerged: 1) characteristics of quality in clinical notes, 2) desired elements within the clinical notes and 3) system supports to improve the quality of clinical notes. We identified 11 codes to describe characteristics of clinical notes, 20 codes to describe desired elements in quality clinical notes and 11 codes to describe clinical system elements that support quality when writing clinical notes. While there was substantial overlap between the aspects of quality described by the four stakeholder groups, only clinicians and administrators identified ease of translation into billing codes as an important characteristic of a quality note. Only patients rated prioritization of their medical problems as an aspect of quality. Nurses included care and education delivered to the patient, information added by the patient, interdisciplinary information, and infection alerts as important content. Perspectives of these four stakeholder groups provide a comprehensive description of quality in outpatient clinical documentation. The resulting description of characteristics and content necessary for quality notes provides a research-based foundation for assessing the quality of clinical documentation in outpatient health care settings.

Which positive factors determine the GP satisfaction in clinical practice? A systematic literature review.

PubMed

Le Floch, B; Bastiaens, H; Le Reste, J Y; Lingner, H; Hoffman, R D; Czachowski, S; Assenova, R; Koskela, T H; Klemenc-Ketis, Z; Nabbe, P; Sowinska, A; Montier, T; Peremans, L

2016-09-13

Looking at what makes General Practitioners (GPs) happy in their profession, may be important in increasing the GP workforce in the future. The European General Practice Research Network (EGPRN) created a research team (eight national groups) in order to clarify the factors involved in GP job satisfaction throughout Europe. The first step of this study was a literature review to explore how the satisfaction of GPs had been studied before. The research question was "Which factors are related to GP satisfaction in Clinical Practice?" Systematic literature review according to the PRISMA statement. The databases searched were Pubmed, Embase and Cochrane. All articles were identified, screened and included by two separate research teams, according to inclusion or exclusion criteria. Then, a qualitative appraisal was undertaken. Next, a thematic analysis process was undertaken to capture any issue relevant to the research question. The number of records screened was 458. One hundred four were eligible. Finally, 17 articles were included. The data revealed 13 subthemes, which were grouped into three major themes for GP satisfaction. First there were general profession-related themes, applicable to many professions. A second group of issues related specifically to a GP setting. Finally, a third group was related to professional life and personal issues. A number of factors leading to GP job satisfaction, exist in literature They should be used by policy makers within Europe to increase the GP workforce. The research team needs to undertake qualitative studies to confirm or enhance those results.

The STARD Statement for Reporting Diagnostic Accuracy Studies: Application to the History and Physical Examination

PubMed Central

Rennie, Drummond; Bossuyt, Patrick M. M.

2008-01-01

Summary Objective The Standards for Reporting of Diagnostic Accuracy (STARD) statement provided guidelines for investigators conducting diagnostic accuracy studies. We reviewed each item in the statement for its applicability to clinical examination diagnostic accuracy research, viewing each discrete aspect of the history and physical examination as a diagnostic test. Setting Nonsystematic review of the STARD statement. Interventions Two former STARD Group participants and 1 editor of a journal series on clinical examination research reviewed each STARD item. Suggested interpretations and comments were shared to develop consensus. Measurements and Main Results The STARD Statement applies generally well to clinical examination diagnostic accuracy studies. Three items are the most important for clinical examination diagnostic accuracy studies, and investigators should pay particular attention to their requirements: describe carefully the patient recruitment process, describe participant sampling and address if patients were from a consecutive series, and describe whether the clinicians were masked to the reference standard tests and whether the interpretation of the reference standard test was masked to the clinical examination components or overall clinical impression. The consideration of these and the other STARD items in clinical examination diagnostic research studies would improve the quality of investigations and strengthen conclusions reached by practicing clinicians. Conclusions The STARD statement provides a very useful framework for diagnostic accuracy studies. The group correctly anticipated that there would be nuances applicable to studies of the clinical examination. We offer guidance that should enhance their usefulness to investigators embarking on original studies of a patient’s history and physical examination. PMID:18347878

Methodology Series Module 4: Clinical Trials.

PubMed

Setia, Maninder Singh

2016-01-01

In a clinical trial, study participants are (usually) divided into two groups. One group is then given the intervention and the other group is not given the intervention (or may be given some existing standard of care). We compare the outcomes in these groups and assess the role of intervention. Some of the trial designs are (1) parallel study design, (2) cross-over design, (3) factorial design, and (4) withdrawal group design. The trials can also be classified according to the stage of the trial (Phase I, II, III, and IV) or the nature of the trial (efficacy vs. effectiveness trials, superiority vs. equivalence trials). Randomization is one of the procedures by which we allocate different interventions to the groups. It ensures that all the included participants have a specified probability of being allocated to either of the groups in the intervention study. If participants and the investigator know about the allocation of the intervention, then it is called an "open trial." However, many of the trials are not open - they are blinded. Blinding is useful to minimize bias in clinical trials. The researcher should familiarize themselves with the CONSORT statement and the appropriate Clinical Trials Registry of India.

Methodology Series Module 4: Clinical Trials

PubMed Central

Setia, Maninder Singh

2016-01-01

In a clinical trial, study participants are (usually) divided into two groups. One group is then given the intervention and the other group is not given the intervention (or may be given some existing standard of care). We compare the outcomes in these groups and assess the role of intervention. Some of the trial designs are (1) parallel study design, (2) cross-over design, (3) factorial design, and (4) withdrawal group design. The trials can also be classified according to the stage of the trial (Phase I, II, III, and IV) or the nature of the trial (efficacy vs. effectiveness trials, superiority vs. equivalence trials). Randomization is one of the procedures by which we allocate different interventions to the groups. It ensures that all the included participants have a specified probability of being allocated to either of the groups in the intervention study. If participants and the investigator know about the allocation of the intervention, then it is called an “open trial.” However, many of the trials are not open – they are blinded. Blinding is useful to minimize bias in clinical trials. The researcher should familiarize themselves with the CONSORT statement and the appropriate Clinical Trials Registry of India. PMID:27512184

75 FR 80830 - Center for Scientific Review; Notice of Closed Meetings

Federal Register 2010, 2011, 2012, 2013, 2014

2010-12-23

... Special Emphasis Panel; Member Conflict: Translational Clinical Oncology. Date: January 26-27, 2011. Time... Committee: Endocrinology, Metabolism, Nutrition and Reproductive Sciences Integrated Review Group; Pregnancy... Program Nos. 93.306, Comparative Medicine; 93.333, Clinical Research, 93.306, 93.333, 93.337, 93.393-93...

What can Natural Language Processing do for Clinical Decision Support?

PubMed Central

Demner-Fushman, Dina; Chapman, Wendy W.; McDonald, Clement J.

2009-01-01

Computerized Clinical Decision Support (CDS) aims to aid decision making of health care providers and the public by providing easily accessible health-related information at the point and time it is needed. Natural Language Processing (NLP) is instrumental in using free-text information to drive CDS, representing clinical knowledge and CDS interventions in standardized formats, and leveraging clinical narrative. The early innovative NLP research of clinical narrative was followed by a period of stable research conducted at the major clinical centers and a shift of mainstream interest to biomedical NLP. This review primarily focuses on the recently renewed interest in development of fundamental NLP methods and advances in the NLP systems for CDS. The current solutions to challenges posed by distinct sublanguages, intended user groups, and support goals are discussed. PMID:19683066

Psychometric instrumentation: reliability and validity of instruments used for clinical practice, evidence-based practice projects and research studies.

PubMed

Mayo, Ann M

2015-01-01

It is important for CNSs and other APNs to consider the reliability and validity of instruments chosen for clinical practice, evidence-based practice projects, or research studies. Psychometric testing uses specific research methods to evaluate the amount of error associated with any particular instrument. Reliability estimates explain more about how well the instrument is designed, whereas validity estimates explain more about scores that are produced by the instrument. An instrument may be architecturally sound overall (reliable), but the same instrument may not be valid. For example, if a specific group does not understand certain well-constructed items, then the instrument does not produce valid scores when used with that group. Many instrument developers may conduct reliability testing only once, yet continue validity testing in different populations over many years. All CNSs should be advocating for the use of reliable instruments that produce valid results. Clinical nurse specialists may find themselves in situations where reliability and validity estimates for some instruments that are being utilized are unknown. In such cases, CNSs should engage key stakeholders to sponsor nursing researchers to pursue this most important work.

Presidential address: The origins and evolution of the Mayo Clinic from 1864 to 1939: a Minnesota family practice becomes an international "medical Mecca".

PubMed

Fye, W Bruce

2010-01-01

This paper describes the origins and international impact of the Mayo Clinic through 1939. Multispecialty group practice was invented at the clinic a century ago. A visiting Canadian physician wrote in 1906, "Specialization and cooperation, with the best that can be had in each department, is here the motto. Cannot these principles be tried elsewhere?" Mayo Clinic's major (and underappreciated) role in the development of rigorous postgraduate (specialty) training is addressed. Unlike traditional academic medical centers that emphasize research, Mayo's main mission has always been patient care. This activity has been undertaken in an environment enriched by extensive programs devoted to specialty training and clinical research.

Development of InCVAX as a novel in situ autologous vaccine for metastatic cancers (Conference Presentation)

NASA Astrophysics Data System (ADS)

Hode, Tomas; Alleruzzo, Luciano; Raker, Joseph; Lam, Samuel Siu Kit; Nordquist, Robert E.; Chen, Wei R.

2016-03-01

A novel method, an in situ autologous whole-cell cancer vaccine (inCVAX), is being developed by Immunophotonics, Inc., for the treatment of metastatic cancers. inCVAX combines phototherapy and immunotherapy to potentially induce a systemic anti-tumor immune response in the hosts. Immunophotonics and its academic partners have spent years conducting nonclinical research, developing CMC techniques and conducting clinical research. In 2015 the company initiated a late-stage (II/III) clinical trial in South America for advanced breast cancer patients. The process of developing the inCVAX approach from a laboratory setting into clinical trials requires significant efforts from a group of dedicated engineers, scientists, and physicians. The growth of the company and its business advances demonstrated the determination of a group of visionary investors, entrepreneurs, and business leaders. This talk will chronicle the milestones of the scientific achievement, medical progress, and business development of Immunophotonics.

Clinical Decision Rules for Diagnostic Imaging in the Emergency Department: A Research Agenda.

PubMed

Finnerty, Nathan M; Rodriguez, Robert M; Carpenter, Christopher R; Sun, Benjamin C; Theyyunni, Nik; Ohle, Robert; Dodd, Kenneth W; Schoenfeld, Elizabeth M; Elm, Kendra D; Kline, Jeffrey A; Holmes, James F; Kuppermann, Nathan

2015-12-01

Major gaps persist in the development, validation, and implementation of clinical decision rules (CDRs) for diagnostic imaging. The objective of this working group and article was to generate a consensus-based research agenda for the development and implementation of CDRs for diagnostic imaging in the emergency department (ED). The authors followed consensus methodology, as outlined by the journal Academic Emergency Medicine (AEM), combining literature review, electronic surveys, telephonic communications, and a modified nominal group technique. Final discussions occurred in person at the 2015 AEM consensus conference. A research agenda was developed, prioritizing the following questions: 1) what are the optimal methods to justify the derivation and validation of diagnostic imaging CDRs, 2) what level of evidence is required before disseminating CDRs for widespread implementation, 3) what defines a successful CDR, 4) how should investigators best compare CDRs to clinical judgment, and 5) what disease states are amenable (and highest priority) to development of CDRs for diagnostic imaging in the ED? The concepts discussed herein demonstrate the need for further research on CDR development and implementation regarding diagnostic imaging in the ED. Addressing this research agenda should have direct applicability to patients, clinicians, and health care systems. © 2015 by the Society for Academic Emergency Medicine.

A new challenge in clinical research in childhood ALL: the prospective meta-analysis strategy for intergroup collaboration.

PubMed

Valsecchi, M G; Masera, G

1996-12-01

We consider the problems arising in clinical research on childhood acute lymphoblastic leukemia (ALL). Given the therapeutic progress achieved over the last few decades, any improvement in the outcome for the majority of children with ALL is difficult to assess with the usual size trials. Furthermore, the progress in genetics and molecular biology has now led to the identification of subgroups of children, typically with rare characteristics, for whom new treatments still await evaluation. For both these aspects of clinical research, there is an increasing need for international intergroup cooperation. After a discussion on the role of retrospective meta-analysis and randomized controlled trials in ALL research, we suggest that intergroup studies could be made more feasible, but still scientifically rigorous, by adopting a strategy of prospective meta-analysis. This strategy can be described as follows: i) different groups prospectively plan to ask the same randomized question within their protocols which may differ in other aspects, and to pool their data in order to evaluate treatment effect; ii) the management of the study can be de-centralized, by allowing each group to be responsible for conducting its own protocol. We would like to stimulate the debate on the methodological and practical aspects of research perspectives in ALL (and in pediatric oncology).

Magnetic resonance neurography and diffusion tensor imaging: origins, history, and clinical impact of the first 50,000 cases with an assessment of efficacy and utility in a prospective 5000-patient study group.

PubMed

Filler, Aaron

2009-10-01

Methods were invented that made it possible to image peripheral nerves in the body and to image neural tracts in the brain. The history, physical basis, and dyadic tensor concept underlying the methods are reviewed. Over a 15-year period, these techniques-magnetic resonance neurography (MRN) and diffusion tensor imaging-were deployed in the clinical and research community in more than 2500 published research reports and applied to approximately 50,000 patients. Within this group, approximately 5000 patients having MRN were carefully tracked on a prospective basis. A uniform Neurography imaging methodology was applied in the study group, and all images were reviewed and registered by referral source, clinical indication, efficacy of imaging, and quality. Various classes of image findings were identified and subjected to a variety of small targeted prospective outcome studies. Those findings demonstrated to be clinically significant were then tracked in the larger clinical volume data set. MRN demonstrates mechanical distortion of nerves, hyperintensity consistent with nerve irritation, nerve swelling, discontinuity, relations of nerves to masses, and image features revealing distortion of nerves at entrapment points. These findings are often clinically relevant and warrant full consideration in the diagnostic process. They result in specific pathological diagnoses that are comparable to electrodiagnostic testing in clinical efficacy. A review of clinical outcome studies with diffusion tensor imaging also shows convincing utility. MRN and diffusion tensor imaging neural tract imaging have been validated as indispensable clinical diagnostic methods that provide reliable anatomic pathological information. There is no alternative diagnostic method in many situations. With the elapsing of 15 years, tens of thousands of imaging studies, and thousands of publications, these methods should no longer be considered experimental.

Approaches to studying and manipulating the enteric microbiome to improve autism symptoms

PubMed Central

Frye, Richard E.; Slattery, John; MacFabe, Derrick F.; Allen-Vercoe, Emma; Parker, William; Rodakis, John; Adams, James B.; Krajmalnik-Brown, Rosa; Bolte, Ellen; Kahler, Stephen; Jennings, Jana; James, Jill; Cerniglia, Carl E.; Midtvedt, Tore

2015-01-01

There is a growing body of scientific evidence that the health of the microbiome (the trillions of microbes that inhabit the human host) plays an important role in maintaining the health of the host and that disruptions in the microbiome may play a role in certain disease processes. An increasing number of research studies have provided evidence that the composition of the gut (enteric) microbiome (GM) in at least a subset of individuals with autism spectrum disorder (ASD) deviates from what is usually observed in typically developing individuals. There are several lines of research that suggest that specific changes in the GM could be causative or highly associated with driving core and associated ASD symptoms, pathology, and comorbidities which include gastrointestinal symptoms, although it is also a possibility that these changes, in whole or in part, could be a consequence of underlying pathophysiological features associated with ASD. However, if the GM truly plays a causative role in ASD, then the manipulation of the GM could potentially be leveraged as a therapeutic approach to improve ASD symptoms and/or comorbidities, including gastrointestinal symptoms. One approach to investigating this possibility in greater detail includes a highly controlled clinical trial in which the GM is systematically manipulated to determine its significance in individuals with ASD. To outline the important issues that would be required to design such a study, a group of clinicians, research scientists, and parents of children with ASD participated in an interdisciplinary daylong workshop as an extension of the 1st International Symposium on the Microbiome in Health and Disease with a Special Focus on Autism (www.microbiome-autism.com). The group considered several aspects of designing clinical studies, including clinical trial design, treatments that could potentially be used in a clinical trial, appropriate ASD participants for the clinical trial, behavioral and cognitive assessments, important biomarkers, safety concerns, and ethical considerations. Overall, the group not only felt that this was a promising area of research for the ASD population and a promising avenue for potential treatment but also felt that further basic and translational research was needed to clarify the clinical utility of such treatments and to elucidate possible mechanisms responsible for a clinical response, so that new treatments and approaches may be discovered and/or fostered in the future. PMID:25956237

Collaborative Approach in the Development of High‐Performance Brain–Computer Interfaces for a Neuroprosthetic Arm: Translation from Animal Models to Human Control

PubMed Central

Collinger, Jennifer L.; Kryger, Michael A.; Barbara, Richard; Betler, Timothy; Bowsher, Kristen; Brown, Elke H. P.; Clanton, Samuel T.; Degenhart, Alan D.; Foldes, Stephen T.; Gaunt, Robert A.; Gyulai, Ferenc E.; Harchick, Elizabeth A.; Harrington, Deborah; Helder, John B.; Hemmes, Timothy; Johannes, Matthew S.; Katyal, Kapil D.; Ling, Geoffrey S. F.; McMorland, Angus J. C.; Palko, Karina; Para, Matthew P.; Scheuermann, Janet; Schwartz, Andrew B.; Skidmore, Elizabeth R.; Solzbacher, Florian; Srikameswaran, Anita V.; Swanson, Dennis P.; Swetz, Scott; Tyler‐Kabara, Elizabeth C.; Velliste, Meel; Wang, Wei; Weber, Douglas J.; Wodlinger, Brian

2013-01-01

Abstract Our research group recently demonstrated that a person with tetraplegia could use a brain–computer interface (BCI) to control a sophisticated anthropomorphic robotic arm with skill and speed approaching that of an able‐bodied person. This multiyear study exemplifies important principles in translating research from foundational theory and animal experiments into a clinical study. We present a roadmap that may serve as an example for other areas of clinical device research as well as an update on study results. Prior to conducting a multiyear clinical trial, years of animal research preceded BCI testing in an epilepsy monitoring unit, and then in a short‐term (28 days) clinical investigation. Scientists and engineers developed the necessary robotic and surgical hardware, software environment, data analysis techniques, and training paradigms. Coordination among researchers, funding institutes, and regulatory bodies ensured that the study would provide valuable scientific information in a safe environment for the study participant. Finally, clinicians from neurosurgery, anesthesiology, physiatry, psychology, and occupational therapy all worked in a multidisciplinary team along with the other researchers to conduct a multiyear BCI clinical study. This teamwork and coordination can be used as a model for others attempting to translate basic science into real‐world clinical situations. PMID:24528900

Training Needs of Clinical and Research Professionals to Optimize Minority Recruitment and Retention in Cancer Clinical Trials.

PubMed

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

2017-08-03

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.

A comparison of radical retropubic with perineal prostatectomy for localized prostate cancer within the Uniformed Services Urology Research Group.

PubMed

Lance, R S; Freidrichs, P A; Kane, C; Powell, C R; Pulos, E; Moul, J W; McLeod, D G; Cornum, R L; Brantley Thrasher J

2001-01-01

To review and compare the outcome of patients undergoing radical retropubic prostatectomy (RRP) or radical perineal prostatectomy (RPP) for clinically localized prostate cancer. From 1988 to 1997, 1382 men who were treated by RRP and 316 by RPP were identified from databases of the Uniformed Services Urology Research Group. The following variables were assessed; age, race, prostate-specific antigen (PSA) level before surgery, clinical stage, biopsy Gleason sum, estimated blood loss (EBL), margin-positive rate, pathological stage, biochemical recurrence rate, short and long-term complication rates, impotence and incontinence rates. To eliminate selection bias, the analysis was concentrated on pairs of patients matched by race, preoperative PSA level, clinical stage and biopsy Gleason sum. In the 190 matched patients there were no significant differences between the RRP and RPP groups in either organ-confined (57% vs 55%), margin-positive (39% vs 43%), or biochemical recurrence rates (12.9% vs 17.6% at a mean follow-up of 47.1 vs 42.9 months), respectively. The mean EBL was 1575 mL in the RRP group and 802 mL in the RPP group (P < 0.001). The only significant difference in complication rates was a higher incidence of rectal injury in the RPP group (4.9%) than in the RRP group (none, P < 0.05). In similar populations of patients, RPP offers equivalent organ-confined, margin-positive and biochemical recurrence rates to RRP, while causing significantly less blood loss.

Evaluating information prescriptions in two clinical environments*

PubMed Central

Oliver, Kathleen Burr; Lehmann, Harold P; Wolff, Antonio C; Davidson, Laurie W; Donohue, Pamela K; Gilmore, Maureen M; Craven, Catherine K.

2011-01-01

Objective: The research sought to evaluate whether providing personalized information services by libraries can improve satisfaction with information services for specific types of patients. Methods: Adult breast cancer (BrCa) clinic patients and mothers of inpatient neonatal intensive care unit (NICU) patients were randomized to receive routine information services (control) or an IRx intervention. Results: The BrCa trial randomized 211 patients and the NICU trial, 88 mothers. The BrCa trial showed no statistically significant differences in satisfaction ratings between the treatment and control groups. The IRx group in the NICU trial reported higher satisfaction than the control group regarding information received about diagnosis, treatments, respiratory tradeoffs, and medication tradeoffs. BrCa patients posed questions to librarians more frequently than did NICU mothers, and a higher percentage reported using the website. Questions asked of the librarians by BrCa patients were predominantly clinical and focused on the areas of treatment and side effects. Conclusions: Study results provide some evidence to support further efforts to both implement information prescription projects in selected settings and to conduct additional research on the costs and benefits of services. PMID:21753916

Report from the OMERACT Hand Osteoarthritis Special Interest Group: advances and future research priorities.

PubMed

Kloppenburg, Margreet; Bøyesen, Pernille; Smeets, Wilma; Haugen, Ida K; Haugen, Ida; Liu, Rani; Visser, Willemien; van der Heijde, Désirée M

2014-04-01

Osteoarthritis (OA) is one of the most common musculoskeletal disorders, frequently affecting the hands. In the last decade there has been increased awareness concerning this disorder because of its clinical burden. Unfortunately, only limited treatments for symptom alleviation are available, and no effective treatment for disease modification exists. The lack of treatment is due not only to a lack of understanding of the disease process, but also to poor outcome measures to assess the condition. The OMERACT Hand OA Special Interest Group (SIG) has started to develop a core set of outcome measures for hand OA clinical trials, observational studies, and clinical record keeping. At OMERACT 11, results from a Delphi exercise were presented, and a preliminary set of core domains was discussed. The group attempted to adopt the new OMERACT Filter 2.0 in the process, and literature overviews of conventional radiographs, ultrasonography, and magnetic resonance imaging as outcome measures in hand OA were presented. Discussions that followed highlighted further suggestions for core domains, the heterogeneity of hand OA, and future research priorities.

An innovative and collaborative partnership between patients with rare disease and industry-supported registries: the Global aHUS Registry.

PubMed

Woodward, Len; Johnson, Sally; Walle, Johan Vande; Beck, Joran; Gasteyger, Christoph; Licht, Christoph; Ariceta, Gema

2016-11-21

Patients are becoming increasingly involved in research which can promote innovation through novel ideas, support patient-centred actions, and facilitate drug development. For rare diseases, registries that collect data from patients can increase knowledge of the disease's natural history, evaluate clinical therapies, monitor drug safety, and measure quality of care. The active participation of patients is expected to optimise rare-disease management and improve patient outcomes. However, few reports address the type and frequency of interactions involving patients, and what research input patient groups have. Here, we describe a collaboration between an international group of patient organisations advocating for patients with atypical haemolytic uraemic syndrome (aHUS), the aHUS Alliance, and an international aHUS patient registry (ClinicalTrials.gov NCT01522183). The aHUS Registry Scientific Advisory Board (SAB) invited the aHUS Alliance to submit research ideas important to patients with aHUS. This resulted in 24 research suggestions from patients and patient organisations being presented to the SAB. The proposals were classified under seven categories, the most popular of which were understanding factors that cause disease manifestations and learning more about the clinical and psychological/social impact of living with the disease. Subsequently, aHUS Alliance members voted for up to five research priorities. The top priority was: "What are the outcomes of a transplant without eculizumab and what non-kidney damage is likely in patients with aHUS?". This led directly to the initiation of an ongoing analysis of the data collected in the Registry on patients with kidney transplants. This collaboration resulted in several topics proposed by the aHUS Alliance being selected as priority activities for the aHUS Registry, with one new analysis already underway. A clear pathway was established for engagement between a patient advocacy group and an international research network. This should ensure the development of a long-term partnership which clearly benefits both groups.

Clinical research in implant dentistry: evaluation of implant-supported restorations, aesthetic and patient-reported outcomes.

PubMed

Lang, Niklaus P; Zitzmann, Nicola U

2012-02-01

The articles discussed in working group 3 dealt with specific aspects of clinical research. In this context, the literature reporting on survival and complication rates of implant-supported or implant-tooth supported restorations in longitudinal studies of at least 5 years were discussed. The second aspect dealt with the evaluation of aesthetic outcomes in clinical studies and the related index systems available. Finally, the third aspect discussed dealt with patient-reported outcome measures (PROMs). A detailed appraisal of the available methodology was presented. © 2012 John Wiley & Sons A/S.

Imaging biomarker roadmap for cancer studies

PubMed Central

O’Connor, James P. B.; Aboagye, Eric O.; Adams, Judith E.; Aerts, Hugo J. W. L.; Barrington, Sally F.; Beer, Ambros J.; Boellaard, Ronald; Bohndiek, Sarah E.; Brady, Michael; Brown, Gina; Buckley, David L.; Chenevert, Thomas L.; Clarke, Laurence P.; Collette, Sandra; Cook, Gary J.; deSouza, Nandita M.; Dickson, John C.; Dive, Caroline; Evelhoch, Jeffrey L.; Faivre-Finn, Corinne; Gallagher, Ferdia A.; Gilbert, Fiona J.; Gillies, Robert J.; Goh, Vicky; Griffiths, John R.; Groves, Ashley M.; Halligan, Steve; Harris, Adrian L.; Hawkes, David J.; Hoekstra, Otto S.; Huang, Erich P.; Hutton, Brian F.; Jackson, Edward F.; Jayson, Gordon C.; Jones, Andrew; Koh, Dow-Mu; Lacombe, Denis; Lambin, Philippe; Lassau, Nathalie; Leach, Martin O.; Lee, Ting-Yim; Leen, Edward L.; Lewis, Jason S.; Liu, Yan; Lythgoe, Mark F.; Manoharan, Prakash; Maxwell, Ross J.; Miles, Kenneth A.; Morgan, Bruno; Morris, Steve; Ng, Tony; Padhani, Anwar R.; Parker, Geoff J. M.; Partridge, Mike; Pathak, Arvind P.; Peet, Andrew C.; Punwani, Shonit; Reynolds, Andrew R.; Robinson, Simon P.; Shankar, Lalitha K.; Sharma, Ricky A.; Soloviev, Dmitry; Stroobants, Sigrid; Sullivan, Daniel C.; Taylor, Stuart A.; Tofts, Paul S.; Tozer, Gillian M.; van Herk, Marcel; Walker-Samuel, Simon; Wason, James; Williams, Kaye J.; Workman, Paul; Yankeelov, Thomas E.; Brindle, Kevin M.; McShane, Lisa M.; Jackson, Alan; Waterton, John C.

2017-01-01

Imaging biomarkers (IBs) are integral to the routine management of patients with cancer. IBs used daily in oncology include clinical TNM stage, objective response and left ventricular ejection fraction. Other CT, MRI, PET and ultrasonography biomarkers are used extensively in cancer research and drug development. New IBs need to be established either as useful tools for testing research hypotheses in clinical trials and research studies, or as clinical decision-making tools for use in healthcare, by crossing ‘translational gaps’ through validation and qualification. Important differences exist between IBs and biospecimen-derived biomarkers and, therefore, the development of IBs requires a tailored ‘roadmap’. Recognizing this need, Cancer Research UK (CRUK) and the European Organisation for Research and Treatment of Cancer (EORTC) assembled experts to review, debate and summarize the challenges of IB validation and qualification. This consensus group has produced 14 key recommendations for accelerating the clinical translation of IBs, which highlight the role of parallel (rather than sequential) tracks of technical (assay) validation, biological/clinical validation and assessment of cost-effectiveness; the need for IB standardization and accreditation systems; the need to continually revisit IB precision; an alternative framework for biological/clinical validation of IBs; and the essential requirements for multicentre studies to qualify IBs for clinical use. PMID:27725679

MRI-Targeted or Standard Biopsy for Prostate-Cancer Diagnosis.

PubMed

Kasivisvanathan, Veeru; Rannikko, Antti S; Borghi, Marcelo; Panebianco, Valeria; Mynderse, Lance A; Vaarala, Markku H; Briganti, Alberto; Budäus, Lars; Hellawell, Giles; Hindley, Richard G; Roobol, Monique J; Eggener, Scott; Ghei, Maneesh; Villers, Arnauld; Bladou, Franck; Villeirs, Geert M; Virdi, Jaspal; Boxler, Silvan; Robert, Grégoire; Singh, Paras B; Venderink, Wulphert; Hadaschik, Boris A; Ruffion, Alain; Hu, Jim C; Margolis, Daniel; Crouzet, Sébastien; Klotz, Laurence; Taneja, Samir S; Pinto, Peter; Gill, Inderbir; Allen, Clare; Giganti, Francesco; Freeman, Alex; Morris, Stephen; Punwani, Shonit; Williams, Norman R; Brew-Graves, Chris; Deeks, Jonathan; Takwoingi, Yemisi; Emberton, Mark; Moore, Caroline M

2018-05-10

Multiparametric magnetic resonance imaging (MRI), with or without targeted biopsy, is an alternative to standard transrectal ultrasonography-guided biopsy for prostate-cancer detection in men with a raised prostate-specific antigen level who have not undergone biopsy. However, comparative evidence is limited. In a multicenter, randomized, noninferiority trial, we assigned men with a clinical suspicion of prostate cancer who had not undergone biopsy previously to undergo MRI, with or without targeted biopsy, or standard transrectal ultrasonography-guided biopsy. Men in the MRI-targeted biopsy group underwent a targeted biopsy (without standard biopsy cores) if the MRI was suggestive of prostate cancer; men whose MRI results were not suggestive of prostate cancer were not offered biopsy. Standard biopsy was a 10-to-12-core, transrectal ultrasonography-guided biopsy. The primary outcome was the proportion of men who received a diagnosis of clinically significant cancer. Secondary outcomes included the proportion of men who received a diagnosis of clinically insignificant cancer. A total of 500 men underwent randomization. In the MRI-targeted biopsy group, 71 of 252 men (28%) had MRI results that were not suggestive of prostate cancer, so they did not undergo biopsy. Clinically significant cancer was detected in 95 men (38%) in the MRI-targeted biopsy group, as compared with 64 of 248 (26%) in the standard-biopsy group (adjusted difference, 12 percentage points; 95% confidence interval [CI], 4 to 20; P=0.005). MRI, with or without targeted biopsy, was noninferior to standard biopsy, and the 95% confidence interval indicated the superiority of this strategy over standard biopsy. Fewer men in the MRI-targeted biopsy group than in the standard-biopsy group received a diagnosis of clinically insignificant cancer (adjusted difference, -13 percentage points; 95% CI, -19 to -7; P<0.001). The use of risk assessment with MRI before biopsy and MRI-targeted biopsy was superior to standard transrectal ultrasonography-guided biopsy in men at clinical risk for prostate cancer who had not undergone biopsy previously. (Funded by the National Institute for Health Research and the European Association of Urology Research Foundation; PRECISION ClinicalTrials.gov number, NCT02380027 .).

Determining problems experienced by student nurses in their work with clinical educators in Turkey.

PubMed

Elcigil, Ayfer; Yildirim Sari, Hatice

2007-07-01

Clinical education is considered an indispensable and vital part of nursing education. Educators have an important role in the successful completion of a student's clinical education. The clinical educator's approach, experience and knowledge have an influence on the students. Students encounter certain problems during their clinical practice under the supervision of educators. This study was conducted to determine the nature of the problems student nurses encounter during clinical training in Turkey. The focus-group interviews were used for this study. Three groups of 8, a total group of 24, composed of students completing their third year were included in the interviews. The students in this study had completed their practical training in the departments of internal medicine, surgery, pediatrics, psychiatry and public health. Among the problems mostly encountered by students, as established by the study, were inadequate assessment by the clinical educator, judgment, negative feedback, communication problems, inadequate guidance and overload. At the end of the research, recommendations were that educators should offer information in the direction of student expectations, increase their positive feedback and lighten the academic workload of these students.

Prenatal Education of Parents About Newborn Screening and Residual Dried Blood Spots: A Randomized Clinical Trial.

PubMed

Botkin, Jeffrey R; Rothwell, Erin; Anderson, Rebecca A; Rose, Nancy C; Dolan, Siobhan M; Kuppermann, Miriam; Stark, Louisa A; Goldenberg, Aaron; Wong, Bob

2016-06-01

Research clearly indicates that current approaches to newborn blood spot screening (NBS) education are ineffective. Incorporating NBS education into prenatal care is broadly supported by lay and professional opinion. To determine the efficacy and effect of prenatal education about newborn screening and use of residual dried blood spots (DBS) in research on parental knowledge, attitudes, and behaviors. A randomized clinical trial of prenatal educational interventions, with outcomes measured by survey at 2 to 4 weeks postpartum. Participants were recruited from obstetric clinics in Salt Lake City, Utah; San Francisco, California; and the Bronx, New York. Eligible women were English- or Spanish-speaking adults and did not have a high-risk pregnancy. A total of 901 women were enrolled. Participants who completed the follow-up survey included 212 women in the usual care group (70% retention), 231 in the NBS group (77% retention), and 221 women in the NBS + DBS group (75% retention). Those who completed the survey were similar across the 3 groups with respect to age, ethnicity, race, education, marital status, income, obstetric history, and language. Participants were randomized into 1 of 3 groups: usual care (n = 305), those viewing an NBS movie and brochure (n = 300), and those viewing both the NBS and DBS movies and brochures (n = 296). Two to four weeks postpartum, women completed a 91-item survey by telephone, addressing knowledge, attitudes, and behavior with respect to opting out of NBS or DBS for their child. A total of 901 women (mean age, 31 years) were randomized and 664 completed the follow-up survey. The total correct responses on the knowledge instrument in regard to NBS were 69% in the usual care group, 79% in the NBS group, and 75% in the NBS + DBS group, a significant between-group difference (P < .05). Although all groups showed strong support for NBS, the percentage of women who were "very supportive" was highest in the NBS group (94%), followed by the NBS + DBS group (86%) and was lowest in the usual care group (73%) (P < .001). The interventions were not associated with decisions to decline newborn screening or withdraw residual DBS. Nine women stated that they had declined NBS (all the usual care group; P < .001). With respect to DBS, 5 participants indicated that they contacted the health department to have their child's sample withdrawn after testing: 3 in the NBS + DBS group and 2 in the usual care group (P = .25). Educational interventions can be implemented in the prenatal clinic, using multimedia tools and electronic platforms. Prenatal education is effective in increasing postnatal knowledge and support for these programs. These results are relevant to other contexts in which residual clinical specimens and data are used for research purposes. clinicaltrials.gov Identifier: NCT02676245.

The practice of clinical neuropsychology in Australia.

PubMed

Ponsford, Jennie

2016-11-01

This paper describes the development and practice of clinical neuropsychology in Australia. Clinical Neuropsychology has shown rapid growth in Australia over the past three decades. Comprehensive and specialized training programs are producing high quality graduates who are employed in a broad range of settings or private practice. Australia now has a substantial number of clinical neuropsychologists with specialist training. Whilst the majority of Australian clinical neuropsychologists still undertake assessment predominantly, there are growing opportunities for clinical neuropsychologists in rehabilitation and in a broad range of research contexts. Cultural issues relating to the assessment of Indigenous Australians and immigrants from many countries present significant challenges. Some major contributions have been made in the realms of test development and validation across various age groups. Australian clinical neuropsychologists are also contributing significantly to research in the fields of traumatic brain injury, aging and dementias, epilepsy, memory assessment, rehabilitation, substance abuse, and other psychiatric disorders. Expansion of roles of clinical neuropsychologists, in domains such as rehabilitation and research is seen as essential to underpin continuing growth of employment opportunities for the profession.

Researchers’ and Clinicians’ Perceptions of Recruiting Participants to Clinical Research: A Thematic Meta-Synthesis

PubMed Central

Newington, Lisa; Metcalfe, Alison

2014-01-01

Background Recruiting the desired number of research participants is frequently problematic with resulting financial and clinical implications. The views of individuals responsible for participant recruitment have not been previously reviewed. This systematic review and thematic meta-synthesis explores researchers’ and clinicians’ experiences and perceptions of recruiting participants to clinical research, with the aim of informing improved recruitment systems and strategies. Methods Studies published between January 1995 and May 2013 were identified from: Ovid MEDLINE, Ovid EMBASE, Ovid PSYCHINFO, ASSIA, British Nursing Index, Scopus, Web of Science, CINAHL and PubMed. Included studies were original peer reviewed research, with qualitative methodologies and an aim of exploring the views of clinicians and/or researchers on recruitment to clinical research. Studies discussing the recruitment of patients unable to give informed consent were excluded. The findings sections of the relevant studies were free coded to identify key concepts which were grouped into hierarchical themes. The quality of the identified studies was assessed and the relative contribution of each paper was checked to ensure individual studies did not dominate in any theme. Results Eighteen relevant papers were identified which examined the views of researchers and clinicians in 10 clinical specialties. Five main themes emerged: building a research community, securing resources, the nature of research, professional identities and recruitment strategies. The views of researchers and clinicians were similar, although the role of ‘researcher’ was inconsistently defined. Conclusions The general experience of recruiting participants to clinical research was one of competition and compromise. Competition arose over funding, staffing and participants, and between clinical and research responsibilities. Compromise was needed to create study designs that were acceptable to patients, clinicians and researchers. Forging relationships between clinical and research teams featured extensively, however the involvement of patients and the public within the research community was rarely discussed. PMID:24734142

Evaluating Protocol Lifecycle Time Intervals in HIV/AIDS Clinical Trials

PubMed Central

Schouten, Jeffrey T.; Dixon, Dennis; Varghese, Suresh; Cope, Marie T.; Marci, Joe; Kagan, Jonathan M.

2014-01-01

Background Identifying efficacious interventions for the prevention and treatment of human diseases depends on the efficient development and implementation of controlled clinical trials. Essential to reducing the time and burden of completing the clinical trial lifecycle is determining which aspects take the longest, delay other stages, and may lead to better resource utilization without diminishing scientific quality, safety, or the protection of human subjects. Purpose In this study we modeled time-to-event data to explore relationships between clinical trial protocol development and implementation times, as well as identify potential correlates of prolonged development and implementation. Methods We obtained time interval and participant accrual data from 111 interventional clinical trials initiated between 2006 and 2011 by NIH’s HIV/AIDS Clinical Trials Networks. We determined the time (in days) required to complete defined phases of clinical trial protocol development and implementation. Kaplan-Meier estimates were used to assess the rates at which protocols reached specified terminal events, stratified by study purpose (therapeutic, prevention) and phase group (pilot/phase I, phase II, and phase III/ IV). We also examined several potential correlates to prolonged development and implementation intervals. Results Even though phase grouping did not determine development or implementation times of either therapeutic or prevention studies, overall we observed wide variation in protocol development times. Moreover, we detected a trend toward phase III/IV therapeutic protocols exhibiting longer developmental (median 2 ½ years) and implementation times (>3years). We also found that protocols exceeding the median number of days for completing the development interval had significantly longer implementation. Limitations The use of a relatively small set of protocols may have limited our ability to detect differences across phase groupings. Some timing effects present for a specific study phase may have been masked by combining protocols into phase groupings. Presence of informative censoring, such as withdrawal of some protocols from development if they began showing signs of lost interest among investigators, complicates interpretation of Kaplan-Meier estimates. Because this study constitutes a retrospective examination over an extended period of time, it does not allow for the precise identification of relative factors impacting timing. Conclusions Delays not only increase the time and cost to complete clinical trials, but they also diminish their usefulness by failing to answer research questions in time. We believe that research analyzing the time spent traversing defined intervals across the clinical trial protocol development and implementation continuum can stimulate business process analyses and reengineering efforts that could lead to reductions in the time from clinical trial concept to results, thereby accelerating progress in clinical research. PMID:24980279

Cognitive processes during acute psychosis: the role of heightened responsibility and catastrophic misinterpretations.

PubMed

Luzón, Olga; Harrop, Chris; Nolan, Fiona

2009-07-01

This study investigated the role of cognitive mechanisms underlying obsessive compulsive and panic disorders in psychosis, and in particular, their possible contributions to acute psychosis. A total of 90 participants were recruited comprising three equal-size groups, including two clinical groups (acute and stable) and one non-clinical matched control group. Symptom severity and distress was assessed using the PSYRATS, and questionnaire measures of anxiety and obsessive beliefs were administered to all participants. Individuals with a diagnosis of psychosis reported significantly higher levels of obsessional beliefs and anxiety sensitivity than the non-clinical group. Furthermore, acutely psychotic patients reported a significantly higher sense of responsibility and catastrophic misinterpretation than the stable psychiatric controls, and than samples of OCD and GAD patients. Results suggest that these anxiety processes are particularly important during acute psychotic episodes, beyond the reported comorbidity. The theoretical and clinical implications of these findings, the limitations of the methodology employed, and suggestions for future research are discussed.

"It's Harder Than We Thought It Would Be": A Comparative Case Study of Expert-Novice Experimentation Strategies.

ERIC Educational Resources Information Center

Hmelo-Silver, Cindy E.; Nagarajan, Anandi; Day, Roger S.

2002-01-01

Compares a group of expert cancer researchers with four groups of fourth year medical students (the "novice" groups) engaged in the task of designing a clinical trial to test a new cancer drug using a computer-based modeling tool, the Oncology Thinking Cap. (Contains 24 references.) (Author/YDS)

Evaluating Group Therapy for Aphasia: What Is the Evidence? EBP Briefs. Volume 7, Issue 5

ERIC Educational Resources Information Center

Layfield, Claire A.; Ballard, Kirrie J.; Robin, Donald A.

2013-01-01

Clinical Question: For people with aphasia following a stroke, is group therapy shown to be more effective on communication outcome measures reflecting impairment, activity, and/or participation than individual therapy or no therapy? Method: Review of treatment efficacy research for group intervention in aphasia Study Sources: Cochrane Database of…

Multiple attachments and group psychotherapy: implications for college counseling centers.

PubMed

Marmarosh, Cheri L

2009-10-01

A large body of literature has supported the application of attachment theory to the understanding of college student development and the process of individual psychotherapy. Despite group treatment being one of the major methods of intervention in college counseling centers, there has been very little research guided by attachment theory that has been applied to the area of group psychotherapy. Many current assessment instruments used in college counseling centers can be supported with attachment theory, and many group therapy interventions are aimed at facilitating secure working models of self, other, and groups. This paper explores the importance of personal and group attachments in group psychotherapy and specifically addresses implications for clinical training and research in university counseling centers.

Ethical Challenges and Lessons Learned During the Clinical Development of a Group A Meningococcal Conjugate Vaccine.

PubMed

Martellet, Lionel; Sow, Samba O; Diallo, Aldiouma; Hodgson, Abraham; Kampmann, Beate; Hirve, Siddhivinayak; Tapia, Milagritos; Haidara, Fadima Cheick; Ndiaye, Assane; Diarra, Bou; Ansah, Patrick Odum; Akinsola, Adebayo; Idoko, Olubukola T; Adegbola, Richard A; Bavdekar, Ashish; Juvekar, Sanjay; Viviani, Simonetta; Enwere, Godwin C; Marchetti, Elisa; Chaumont, Julie; Makadi, Marie-Francoise; Pallardy, Flore; Kulkarni, Prasad S; Preziosi, Marie-Pierre; LaForce, F Marc

2015-11-15

The group A meningococcal vaccine (PsA-TT) clinical development plan included clinical trials in India and in the West African region between 2005 and 2013. During this period, the Meningitis Vaccine Project (MVP) accumulated substantial experience in the ethical conduct of research to the highest standards. Because of the public-private nature of the sponsorship of these trials and the extensive international collaboration with partners from a diverse setting of countries, the ethical review process was complex and required strategic, timely, and attentive communication to ensure the smooth review and approval for the clinical studies. Investigators and their site teams fostered strong community relationships prior to, during, and after the studies to ensure the involvement and the ownership of the research by the participating populations. As the clinical work proceeded, investigators and sponsors responded to specific questions of informed consent, pregnancy testing, healthcare, disease prevention, and posttrial access. Key factors that led to success included (1) constant dialogue between partners to explore and answer all ethical questions; (2) alertness and preparedness for emerging ethical questions during the research and in the context of evolving international ethics standards; and (3) care to assure that approaches were acceptable in the diverse community contexts. Many of the ethical issues encountered during the PsA-TT clinical development are familiar to groups conducting field trials in different cultural settings. The successful approaches used by the MVP clinical team offer useful examples of how these problems were resolved. ISRCTN17662153 (PsA-TT-001); ISRTCN78147026 (PsA-TT-002); ISRCTN87739946 (PsA-TT-003); ISRCTN46335400 (PsA-TT-003a); ISRCTN82484612 (PsA-TT-004); CTRI/2009/091/000368 (PsA-TT-005); PACTR ATMR2010030001913177 (PsA-TT-006); PACTR201110000328305 (PsA-TT-007). © The Author 2015. Published by Oxford University Press on behalf of the Infectious Diseases Society of America.

Practice development 'without walls' and the quandary of corporate practice.

PubMed

Graham, Iain; Fielding, Carol; Rooke, Debbie; Keen, Steven

2006-08-01

The context of this study is a group of clinical nurse specialists from across a Trust seeking accreditation as a practice development unit. The university was asked to facilitate the accreditation process via 11 2-hour learning sessions (including a one-hour focus group). During initial discussions between the university and practice development unit, the overarching research question for this study was set as: 'what are the main roles and responsibilities of clinical nurse specialists?' Although there is no known study of a practice development unit based beyond a ward or speciality, the central tenet of the practice development unit literature is that units must demonstrate their worth if they are to survive and harness senior management support in doing so. Data gleaned from the transcribed audio tape-recordings of the learning sessions were studied at least three times to ensure transcription accuracy and produce detailed charts. Ethical approval was granted by the appropriate Local Research Ethics Committee and written informed consent obtained from clinical nurse specialists. The study lasted 30 months and ended in October 2004. The four crucial statements that give meaning to specialist practice are: quality care giver; expert; information giver and initiator of change. Further analysis reveals the area of corporate and political practice as being missing from this and other lists of clinical nurse specialist attributes found in the literature. Clinical nurse specialists characterize their relationship with the Trust in terms of dichotomy--differing agendas and perceptions of value. The specialist role requires professional development in the areas of corporate and political acumen and professional business management. While the findings of this study relate to one Trust and a group of 16 clinical nurse specialists, with careful application they may be transferable to other settings and groups of senior nurses.

TU-E-BRB-03: Overview of Proposed TG-132 Recommendations

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

Brock, K.

2015-06-15

Deformable image registration (DIR) is developing rapidly and is poised to substantially improve dose fusion accuracy for adaptive and retreatment planning and motion management and PET fusion to enhance contour delineation for treatment planning. However, DIR dose warping accuracy is difficult to quantify, in general, and particularly difficult to do so on a patient-specific basis. As clinical DIR options become more widely available, there is an increased need to understand the implications of incorporating DIR into clinical workflow. Several groups have assessed DIR accuracy in clinically relevant scenarios, but no comprehensive review material is yet available. This session will alsomore » discuss aspects of the AAPM Task Group 132 on the Use of Image Registration and Data Fusion Algorithms and Techniques in Radiotherapy Treatment Planning official report, which provides recommendations for DIR clinical use. We will summarize and compare various commercial DIR software options, outline successful clinical techniques, show specific examples with discussion of appropriate and inappropriate applications of DIR, discuss the clinical implications of DIR, provide an overview of current DIR error analysis research, review QA options and research phantom development and present TG-132 recommendations. Learning Objectives: Compare/contrast commercial DIR software and QA options Overview clinical DIR workflow for retreatment To understand uncertainties introduced by DIR Review TG-132 proposed recommendations.« less

Bias in dissemination of clinical research findings: structured OPEN framework of what, who and why, based on literature review and expert consensus.

PubMed

Bassler, Dirk; Mueller, Katharina F; Briel, Matthias; Kleijnen, Jos; Marusic, Ana; Wager, Elizabeth; Antes, Gerd; von Elm, Erik; Altman, Douglas G; Meerpohl, Joerg J

2016-01-21

The aim of this study is to review highly cited articles that focus on non-publication of studies, and to develop a consistent and comprehensive approach to defining (non-) dissemination of research findings. We performed a scoping review of definitions of the term 'publication bias' in highly cited publications. Ideas and experiences of a core group of authors were collected in a draft document, which was complemented by the findings from our literature search. The draft document including findings from the literature search was circulated to an international group of experts and revised until no additional ideas emerged and consensus was reached. We propose a new approach to the comprehensive conceptualisation of (non-) dissemination of research. Our 'What, Who and Why?' approach includes issues that need to be considered when disseminating research findings (What?), the different players who should assume responsibility during the various stages of conducting a clinical trial and disseminating clinical trial documents (Who?), and motivations that might lead the various players to disseminate findings selectively, thereby introducing bias in the dissemination process (Why?). Our comprehensive framework of (non-) dissemination of research findings, based on the results of a scoping literature search and expert consensus will facilitate the development of future policies and guidelines regarding the multifaceted issue of selective publication, historically referred to as 'publication bias'. 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/

Mental Health Practitioners' Reflections on Psychological Work in Uganda: Exploring Perspectives from Different Professions

ERIC Educational Resources Information Center

Hall, Jennifer; d'Ardenne, Patricia; Nsereko, James; Kasujja, Rosco; Baillie, Dave; Mpango, Richard; Birabwa, Harriet; Hunter, Elaine

2014-01-01

The Butabika-East London Link collaborated with Ugandan mental health services to train mental health professionals (psychiatric clinical officers, "PCOs", and clinical psychologists and psychiatrists, "Core Group") in psychological therapies. The aims of this research were to investigate how professionals were applying and…

Simulation and the Development of Clinical Judgment: A Quantitative Study

ERIC Educational Resources Information Center

Holland, Susan

2015-01-01

The purpose of this quantitative pretest posttest quasi-experimental research study was to explore the effect of the NESD on clinical judgment in associate degree nursing students and compare the differences between groups when the Nursing Education Simulation Design (NESD) guided simulation in order to identify educational strategies promoting…

The Value of Clinical Jazz: Teaching Critical Reflection on, in, and Toward Action.

PubMed

Casapulla, Sharon; Longenecker, Randall; Beverly, Elizabeth A

2016-05-01

Clinical Jazz is a small-group strategy in medical education designed to develop interpersonal skills and improve doctor-patient and interprofessional relationships. The purpose of this study was to explore medical students' and faculty facilitators' perceived value of Clinical Jazz. We conducted a modified Nominal Group Process with participating medical students (n=21), faculty facilitators (n=5), and research team members (n=3). Students and faculty facilitators independently answered the question, "What do you value about Clinical Jazz?" We then conducted content and thematic analyses on the resulting data. Three themes emerged during analysis: (1) students and faculty appreciated the opportunity to learn and practice a thoughtful and structured process for problem solving, (2) students and faculty valued the safety of the group process in sharing a diversity of perspectives on topics in medicine, and (3) students and faculty acknowledged the importance of addressing real and challenging problems that are rarely addressed in formal lectures and other planned small-group settings. Clinical Jazz provides students and faculty with the opportunity to address the hidden and/or informal curriculum in medical education, while providing a safe space and time to solve important clinical and interprofessional problems.

Comparing Clinical Nurse Specialist Students' Socialization Based on Magnet Employment.

PubMed

Ares, Terri L

The purpose of this study is to ascertain if clinical nurse specialist students differed on measures of professional socialization based on employment in a Magnet-oriented hospital. A secondary analysis of data from a previous national study of the socialization of clinical nurse specialist students was used. Anticipatory socialization variables (nursing leadership, workplace exposure to the role, and preconceived impression of the role), mentorship by a clinical nurse specialist, and socialization outcomes (self-concept, perceived preparedness for practice, and nursing specialty certification) were explored. Data were divided into 2 groups: Magnet (n = 106) and non-Magnet (n = 119). Comparisons between the groups on researcher-designed items and the Professionalism and Work Ethic subscales of the Nurses Self-Description Form were analyzed. The Magnet group was more likely to be exposed to the clinical nurse specialist role in the workplace. Overall, there were no group differences in socialization outcome measures; but in the subset of students with workplace exposure to the role, those with Magnet experience had higher professionalism self-concept scores. Magnet employment was not a significant socializing factor for nurses pursuing clinical nurse specialist education. The graduate program is likely the primary socializing agent for these students.

Building youths' resilience within a psychiatric outpatient setting: results from a pilot clinical intervention project.

PubMed

Waaktaar, Trine; Christie, Helen J; Borge, Anne Inger Helmen; Torgersen, Svenn

2004-02-01

The relevance of resilience research for clinical practice has not yet been established. In this intervention pilot study, the aim was to explore how group work based on enhancing the participants' creativity, self-efficacy, active coping, and sense of continuity could be utilized within a clinical context for adolescents with stressful background experiences. 31 participants and 24 parents completed pre-, post-, and 1-yr. follow-up assessments of the youths' behavior difficulties, as well as depression, positive life attitude, coping, and prosocial behavior. Apart from a drop in self-rated prosocial behavior, no significant treatment effects were found. Implications for clinical practice and research are indicated.

Statewide Tuskegee Alliance for clinical trials. A community coalition to enhance minority participation in medical research.

PubMed

Fouad, M N; Partridge, E; Wynn, T; Green, B L; Kohler, C; Nagy, S

2001-01-01

Cancer mortality rates for all sites are nearly 2.5 times greater for African-Americans compared with whites. In addition, there are data implying that cancer treatment outcomes for minorities are unfavorable compared with whites. Whether this is due to poor access to health care or a biologic property of malignancies occurring in specific populations remains to be determined. Because of these unknown factors, targeting minorities for clinical trials may contribute toward the reduction of the overall morbidity and mortality associated with specific cancers. The current study describes the establishment of a genuine collaborative partnership between the targeted minority community and clinical investigators at the University of Alabama at Birmingham. This partnership was formed for the purpose of identifying strategies that would enhance the accrual and retention of minority participants into current and future cancer prevention and control trials. Focus groups and key informant interviews were conducted to ascertain the community's perception of participating in clinical trials. The majority of focus group participants were unclear regarding the nature of clinical trials. Participants indicated that they would participate in research studies if they received adequate information regarding the purpose and benefits of the study, and if the charge came from a pastor or physician. Barriers to participation included time commitments, family obligations, whether blood was involved, and past experiences. The majority of the participants indicated that their knowledge of the Tuskegee Syphilis Study did not influence their decision to participate in research. A major outcome of the conference was the formation of the Statewide Tuskegee Alliance Coalition. The planning coalition decided to continue their efforts to work with communities and promote cancer awareness among minorities. After the conference, the coalition conducted several meetings and in July 1998, 1 year after the conference, the coalition selected a chair, co-chair, and a formal name for the organized group. The planning, development, and implementation of this conference provided a valuable experience for researchers and community members. It was discovered that community involvement in the early phase of this project contributed to its success. Furthermore, the partnership that developed between researchers (academic institutions) and communities successfully provided an infrastructure that supported the interest of both groups. Copyright 2001 American Cancer Society.

The history of the Gynecologic Cancer Study Group (GCSG) of the Japan Clinical Oncology Group (JCOG).

PubMed

Onda, Takashi; Konishi, Ikuo; Yoshikawa, Hiroyuki; Kamura, Toshiharu

2011-10-01

The Gynecologic Cancer Study Group (GCSG) of the Japan Clinical Oncology Group (JCOG) was organized in 1994. The GCSG has developed under the leadership of three successive group representatives, five principal study investigators, the cooperation of group members and the support of several public research funds. At present, 38 institutions are participating as active members of the GCSG of the JCOG. In addition to gynecologic oncologists, medical oncologists, pathologists and radiotherapists are participating in our group. Our group manages female genital malignancies including uterine cervical, endometrial, ovarian, tubal and vulvar cancers. Because the incidences of uterine cervical (in younger women), endometrial and ovarian cancer have increased in Japan in recent years, we are developing new standard treatments especially for these malignancies. As of 31 May 2011, our group has conducted six JCOG clinical trials (three completed and three ongoing) and completed one JCOG accompanying study, which is now in preparation for publication. Our group has also conducted several retrospective studies, and Phase I and II trials independent of the JCOG Data Center. Our aim is to conduct unique and high-quality clinical trials which we can appeal to the world. In this review, we present the organization and achievements of our group, along with a list of participating institutions, as the history of the GCSG of the JCOG.

[Clinical research. XIII. Research design contribution in the structured revision of an article].

PubMed

Talavera, Juan O; Rivas-Ruiz, Rodolfo

2013-01-01

The quality of information obtained in accordance to research design is integrated to the revision structured in relation to the causality model, used in the article "Reduction in the Incidence of Nosocomial Pneumonia Poststroke by Using the 'Turn-mob' Program", which corresponds to a clinical trial design. Points to identify and analyze are ethical issues in order to safeguard the security and respect for patients, randomization that seek to create basal homogeneous groups, subjects with the same probability of receiving any of the maneuvers in comparison, with the same pre maneuver probability of adherence, and which facilitate the blinding of outcome measurement and the distribution between groups of subjects with the same probability of leaving the study for reasons beyond the maneuvers. Other aspects are the relativity of comparison, the blinding of the maneuver, the parallel application of comparative maneuver, early stopping, and analysis according to the degree of adherence. The analysis in accordance with the design is complementary, since it is done based on the architectural model of causality, and the statistical and clinical relevance consideration.

MRI-Derived Cellularity Index as a Potential Noninvasive Imaging Biomarker of Prostate Cancer

DTIC Science & Technology

2016-12-01

whole mount pathology sections. Analysis of these UCLA data resulted in four published manuscripts (White et al, Cancer Research 2014; Rakow-Penner...Yamin et al., Clinical Cancer Research , 2016) RSI-MRI mean z-score grouped by pathologic Gleason grade. Mean RSI-MRI cellularity index represented as...Figure 2). A quantitative validation of this approach is now provided in this study. Specifically, in a group of patients with known PCa, ROC

A research agenda for gastrointestinal and endoscopic surgery.

PubMed

Urbach, D R; Horvath, K D; Baxter, N N; Jobe, B A; Madan, A K; Pryor, A D; Khaitan, L; Torquati, A; Brower, S T; Trus, T L; Schwaitzberg, S

2007-09-01

Development of a research agenda may help to inform researchers and research-granting agencies about the key research gaps in an area of research and clinical care. The authors sought to develop a list of research questions for which further research was likely to have a major impact on clinical care in the area of gastrointestinal and endoscopic surgery. A formal group process was used to conduct an iterative, anonymous Web-based survey of an expert panel including the general membership of the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES). In round 1, research questions were solicited, which were categorized, collapsed, and rewritten in a common format. In round 2, the expert panel rated all the questions using a priority scale ranging from 1 (lowest) to 5 (highest). In round 3, the panel re-rated the 40 questions with the highest mean priority score in round 2. A total of 241 respondents to round 1 submitted 382 questions, which were reduced by a review panel to 106 unique questions encompassing 33 topics in gastrointestinal and endoscopic surgery. In the two successive rounds, respectively, 397 and 385 respondents ranked the questions by priority, then re-ranked the 40 questions with the highest mean priority score. High-priority questions related to antireflux surgery, the oncologic and immune effects of minimally invasive surgery, and morbid obesity. The question with the highest mean priority ranking was: "What is the best treatment (antireflux surgery, endoluminal therapy, or medication) for GERD?" The second highest-ranked question was: "Does minimally invasive surgery improve oncologic outcomes as compared with open surgery?" Other questions covered a broad range of research areas including clinical research, basic science research, education and evaluation, outcomes measurement, and health technology assessment. An iterative, anonymous group survey process was used to develop a research agenda for gastrointestinal and endoscopic surgery consisting of the 40 most important research questions in the field. This research agenda can be used by researchers and research-granting agencies to focus research activity in the areas most likely to have an impact on clinical care, and to appraise the relevance of scientific contributions.

Standard operating procedures for serum and plasma collection: early detection research network consensus statement standard operating procedure integration working group.

PubMed

Tuck, Melissa K; Chan, Daniel W; Chia, David; Godwin, Andrew K; Grizzle, William E; Krueger, Karl E; Rom, William; Sanda, Martin; Sorbara, Lynn; Stass, Sanford; Wang, Wendy; Brenner, Dean E

2009-01-01

Specimen collection is an integral component of clinical research. Specimens from subjects with various stages of cancers or other conditions, as well as those without disease, are critical tools in the hunt for biomarkers, predictors, or tests that will detect serious diseases earlier or more readily than currently possible. Analytic methodologies evolve quickly. Access to high-quality specimens, collected and handled in standardized ways that minimize potential bias or confounding factors, is key to the "bench to bedside" aim of translational research. It is essential that standard operating procedures, "the how" of creating the repositories, be defined prospectively when designing clinical trials. Small differences in the processing or handling of a specimen can have dramatic effects in analytical reliability and reproducibility, especially when multiplex methods are used. A representative working group, Standard Operating Procedures Internal Working Group (SOPIWG), comprised of members from across Early Detection Research Network (EDRN) was formed to develop standard operating procedures (SOPs) for various types of specimens collected and managed for our biomarker discovery and validation work. This report presents our consensus on SOPs for the collection, processing, handling, and storage of serum and plasma for biomarker discovery and validation.

What do young people with rheumatic disease believe to be important to research about their condition? A UK-wide study.

PubMed

Parsons, Suzanne; Thomson, Wendy; Cresswell, Katharine; Starling, Bella; McDonagh, Janet E

2017-07-03

The involvement of people of all ages including young people in research is now widely advocated but prioritisation of research topics is still driven largely by professional agendas. Evidence from adult literature has reported a mismatch between a researcher and patient generated list of research topics. There have been no studies to date exploring the priorities of young people with long term conditions other than in SLE. The study aimed to explore the research priorities of young people across the UK with respect to rheumatic conditions. Focus groups were undertaken with young people aged 11-24 years with rheumatic conditions recruited across the UK via members of the Barbara Ansell National Network for Adolescent Rheumatology BANNAR and relevant national charities. Data was analysed using a Framework approach. Participants discussed their beliefs about what should be researched in: Basic Science; Clinical Medicine; Health Services, Psychosocial, and Public Health. They were then invited to prioritize these areas in terms of how much funding they should receive. Thirteen focus groups were held involving 63 participants (18 males: 45 females, mean age 16 years, range 10 to 24) in all four nations of the UK. Young people's research priorities were influenced by whether they felt research would achieve benefits for all or just some patients and long or short term goals. Another influence was whether participants felt that research areas were already well funded. Across all groups, Basic Science was a key priority and participants felt that psychosocial research should be prioritized more. Health Services Research was a lower priority, as the majority of participants were happy with their care. Clinical medicine was not a high priority as young people were happy with their medication or uncomfortable with trying new ones. Finally, for nearly all groups, Public Health was a low priority. Differences were also observed between the two age groups and across the geographically diverse focus groups. Understanding young people's research priorities is important to develop research that is in tune with their needs. The results highlight the importance of considering the whole age range of adolescence and young adulthood as well as geographical diversity. The findings from this work will inform the future research of the Barbara Ansell National Network for Adolescent Rheumatology BANNAR in the UK.

Measuring the health effects of gender.

PubMed

Phillips, S P

2008-04-01

The health effects of gender are mediated via group-level constraints of sex roles and norms, discrimination and marginalisation of individuals, and internalisation of the stresses of role discordance. Although gender is frequently a lens through which data are interpreted there are few composite measures that insert gender as an independent variable into research design. Instead, sex disaggregation of data is often conflated with gender, identifying statistically significant but sometimes clinically insignificant sex differences. To directly assess the impact of gender on wellbeing requires development of group and individual-level derived variables. At the ecological level such a summative variable could be composed of a selection of group-level measures of equality between sexes. This gender index could be used in ecological and individual-level studies of health outcomes. A quantitative indicator of gender role acceptance and of the personal effects of gender inequities could insert the often hidden variable of gender into individual-level clinical research.

Functional brain imaging in respiratory medicine.

PubMed

Pattinson, Kyle

2015-06-01

Discordance of clinical symptoms with markers of disease severity remains a conundrum in a variety of respiratory conditions. The breathlessness of chronic lung disease correlates poorly with spirometry, yet is a better predictor of mortality. In chronic cough, symptoms are often evident without clear physical cause. In asthma, the terms 'over perceivers' and 'under perceivers' are common parlance. In all these examples, aberrant brain mechanisms may explain the mismatch between symptoms and pathology. Functional MRI is a non-invasive method of measuring brain function. It has recently become significantly advanced enough to be useful in clinical research and to address these potential mechanisms. This article explains how FMRI works, current understanding from FMRI in breathlessness, cough and asthma and suggests possibilities for future research. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

Case Study in Designing a Research Fundamentals Curriculum for Community Health Workers: A University - Community Clinic Collaborative

PubMed Central

Dumbauld, Jill; Kalichman, Michael; Bell, Yvonne; Dagnino, Cynthia; Taras, Howard

2014-01-01

Introduction Community health workers are increasingly incorporated into research teams. Training them in research methodology and ethics, while relating these themes to a community’s characteristics, may help to better integrate these health promotion personnel into research teams. Approach and Strategies This pilot project involved the design and implementation of an interactive training course on research fundamentals for community health workers from clinics in a rural, predominately Latino setting. Curriculum development was guided by collaborative activities arising from a university - clinic partnership, a community member focus group, and the advice of community-based researchers. The resulting curriculum was interactive and stimulated dialogue between trainees and academic researchers. Discussion and Conclusions Collaboration between researchers and health agency professionals proved to be a practical method to develop curriculum for clinic staff. An interactive curriculum allowed trainees to incorporate community-specific themes into the discussion. This interaction educated course instructors from academia about the community as much as it educated course participants about research. The bidirectional engagement that occurs during the development and teaching of this course can potentially lead to research partnerships between community agencies and academia, better-informed members of the public, and research protocols that accommodate community characteristics. PMID:24121537

The Impact of Structured Inter-professional Education on Health Care Professional Students' Perceptions of Collaboration in a Clinical Setting

PubMed Central

Lee, Sam; Lombardo, Samantha; Salama, Mariam; Ellis, Sandi; Kay, Theresa; Davies, Robyn; Landry, Michel D.

2012-01-01

ABSTRACT Purpose: To examine how a structured inter-professional education (IPE) clinical placement influences health care professional (HCP) students' perceptions of inter-professional collaboration (IPC) relative to that of students in a traditional clinical placement. Methods: This study used a mixed-methods design. The Interdisciplinary Education Perception Scale (IEPS) was administered to HCP students (n=36) in two Toronto hospitals before and after a structured 5-week IPE clinical placement to examine changes in their perceptions of IPC. Students in a traditional clinical placement (n=28) were used as a control group. Focus groups were then conducted with seven students who took part in the structured IPE clinical placement. A coding framework was devised a priori, and the qualitative results were used to explain the quantitative findings. Results: There were no statistically significant differences between groups after the structured IPE clinical placement, but the intervention group showed a greater positive trend in total IEPS scores from baseline to follow-up. Qualitative data suggest that students valued the knowledge and skills gained through the structured IPE clinical placement. Conclusions: Findings suggest that structured IPE clinical placements may provide students with valuable collaborative learning opportunities, enhanced respect for other professionals, and insight into the value of IPC in healthcare delivery. More research is needed to explore other factors that influence specific perceptions among physical therapy students. PMID:23450044

[Involvement of researchers with patient associations: what is the role of their opinions, their clinical activity and their nature?].

PubMed

Demagny, Lise; Bungener, Martine; Faurisson, François

2015-11-01

Although the involvement of patient associations in biomedical research is well known, conversely, researchers' views and perceptions of these associations have remained unknown. For this reason, Inserm's Patients' Association Liaison Group (GRAM) launched the CAIRNET survey in 2012, based on questionnaires and interviews conducted with researchers working at Inserm. The variety of their opinions made it possible to distinguish four profiles, the committed, the pragmatic, the reticent and the distant. Thus 41 % of respondents reported ongoing relationships with at least one association, 72 % for the committed and 16 % for the distant. Although these relationships are formed more easily among researchers involved in clinical activity, they also encourage collaborations between clinicians and basic researchers. The apparently lower degree of involvement of female researchers proved to be associated with a lower level of clinical activity, limited permanent recruitment, and a lower hierarchical status. © 2015 médecine/sciences – Inserm.

Views of potential research participants on financial conflicts of interest: barriers and opportunities for effective disclosure.

PubMed

Weinfurt, Kevin P; Friedman, Joëlle Y; Allsbrook, Jennifer S; Dinan, Michaela A; Hall, Mark A; Sugarman, Jeremy

2006-09-01

There is little guidance regarding how to disclose researchers' financial interests to potential research participants. To determine what potential research participants want to know about financial interests, their capacity to understand disclosed information and its implications, and the reactions of potential research participants to a proposed disclosure statement. Sixteen focus groups in 3 cities, including 6 groups of healthy adults, 6 groups of adults with mild chronic illness, 1 group of parents of healthy children, 1 group of parents of children with leukemia or brain tumor, 1 group of adults with heart failure, and 1 group of adults with cancer. Focus group discussions covered a range of topics including financial relationships in clinical research, whether people should be told about them, and how they should be told. Audio-recordings of focus groups were transcribed, verified, and coded for analysis. Participants wanted to know about financial interests, whether or not those interests would affect their participation. However, they varied in their desire and ability to understand the nature and implications of financial interests. Whether disclosure was deemed important depended upon the risk of the research. Trust in clinicians was also related to views regarding disclosure. If given the opportunity to ask questions during the consent process, some participants would not have known what to ask; however, after the focus group sessions, participants could identify information they would want to know. Financial interests are important to potential research participants, but obstacles to effective disclosure exist.

The information sources and journals consulted or read by UK paediatricians to inform their clinical practice and those which they consider important: a questionnaire survey

PubMed Central

Jones, Teresa H; Hanney, Steve; Buxton, Martin J

2007-01-01

Background Implementation of health research findings is important for medicine to be evidence-based. Previous studies have found variation in the information sources thought to be of greatest importance to clinicians but publication in peer-reviewed journals is the traditional route for dissemination of research findings. There is debate about whether the impact made on clinicians should be considered as part of the evaluation of research outputs. We aimed to determine first which information sources are generally most consulted by paediatricians to inform their clinical practice, and which sources they considered most important, and second, how many and which peer-reviewed journals they read. Methods We enquired, by questionnaire survey, about the information sources and academic journals that UK medical paediatric specialists generally consulted, attended or read and considered important to their clinical practice. Results The same three information sources – professional meetings & conferences, peer-reviewed journals and medical colleagues – were, overall, the most consulted or attended and ranked the most important. No one information source was found to be of greatest importance to all groups of paediatricians. Journals were widely read by all groups, but the proportion ranking them first in importance as an information source ranged from 10% to 46%. The number of journals read varied between the groups, but Archives of Disease in Childhood and BMJ were the most read journals in all groups. Six out of the seven journals previously identified as containing best paediatric evidence are the most widely read overall by UK paediatricians, however, only the two most prominent are widely read by those based in the community. Conclusion No one information source is dominant, therefore a variety of approaches to Continuing Professional Development and the dissemination of research findings to paediatricians should be used. Journals are an important information source. A small number of key ones can be identified and such analysis could provide valuable additional input into the evaluation of clinical research outputs. PMID:17224061

Research Abstracts of 1981.

DTIC Science & Technology

1981-12-01

Development in Initally Caries-Free Naval Recruits" (Abstract #898) , 13. M. R. WIRTHLIN* and E. B. HANCOCK - " Regeneration After Biologic Treat- ment of...These variables can be grouped into four categories: oral condition (N-7), clinical attendance (N=4), personal characteristics (N=4), and record...Histologic examination of the pulp tissue in these teeth were related to the clinical criteria prior to extraction. Clinical criteria associated

Assessing the impact of bibliographical support on the quality of medical care in patients admitted to an internal medicine service: a prospective clinical, open, randomised two-arm parallel study.

PubMed

Pastori, Matteo Mario; Sarti, Manuela; Pons, Marco; Barazzoni, Fabrizio

2014-10-01

To assess and quantify the impact of the literature in diagnostic decisions and treatment of patients admitted to an internal medicine service using the methodology of evidence-based medicine. From November 2012 to February 2013, patients who were hospitalised in the internal medicine service of Regional Hospital of Lugano (Switzerland) and generated questions on medical care were randomly assigned to two groups: an 'intervention group' (supported by the literature research) and a 'control group' (not supported by the literature research). The information obtained from the literature was submitted by email to all members of the medical team within 12 h after asking the question. Two hundred and one participants, from 866 patients hospitalised in the analysed period, divided into intervention (n=101) and control (n=100) groups, generated questions. In the intervention group, bibliographical research was possible for 98 participants. The medical team accepted the results and implemented the research for 90.8% of these participants (89/98). Statistical analyses were carried out on the intention-to-treat and on the per-protocol populations. Bibliographical research had a significant protective effect on transfer to an intensive care unit (relative risk (RR)=0.30; 95% CI 0.10 to 0.90; χ²=5.3, p=0.02) and hospital readmissions were also influenced by bibliographical research (RR=0.42; 95% CI 0.17 to 1.0; χ²=3.36, p=0.05) in the intention-to-treat population. Our results point out the importance of bibliographical support on the quality of medical care. In particular, they show its possible impact on clinical outcome. EOC Registry (registration number: 14-055).

Protocol for developing, disseminating and implementing a core outcome set for endometriosis.

PubMed

Hirsch, Martin; Duffy, James M N; Barker, Claire; Hummelshoj, Lone; Johnson, Neil P; Mol, Ben; Khan, Khalid S; Farquhar, Cindy

2016-12-21

Endometriosis is a common gynaecological disease characterised by pain and subfertility. Randomised controlled trials evaluating treatments for endometriosis have reported many different outcomes and outcome measures. This variation restricts effective data synthesis limiting the usefulness of research to inform clinical practice. To address these methodological concerns, we aim to develop, disseminate and implement a core outcome set for endometriosis engaging with key stakeholders, including healthcare professionals, researchers and women with endometriosis. An international steering group has been established, including healthcare professionals, researchers and patient representatives. Potential outcomes identified from a systematic review of the literature will be entered into a modified Delphi method. Key stakeholders will be invited to participate including healthcare professionals, researchers and women with endometriosis. Participants will be invited to score individual outcomes on a nine-point Likert scale anchored between 1 (not important) and 9 (critical). Repeated reflection and rescoring should promote whole and individual stakeholder group converge towards consensus, 'core', outcomes. High-quality outcome measures will be associated with core outcomes. The implementation of a core outcome set for endometriosis within future clinical trials, systematic reviews and clinical guidelines will enhance the availability of comparable data to facilitate evidence-based patient care. This study was prospectively registered with Core Outcome Measures in Effectiveness Trials Initiative; number: 691. 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/.

A Call to Standardize Preanalytic Data Elements for Biospecimens, Part II.

PubMed

Robb, James A; Bry, Lynn; Sluss, Patrick M; Wagar, Elizabeth A; Kennedy, Mary F

2015-09-01

Biospecimens must have appropriate clinical annotation (data) to ensure optimal quality for both patient care and research. Additional clinical preanalytic variables are the focus of this continuing study. To complete the identification of the essential preanalytic variables (data fields) that can, and in some instances should, be attached to every collected biospecimen by adding the additional specific variables for clinical chemistry and microbiology to our original 170 variables. The College of American Pathologists Diagnostic Intelligence and Health Information Technology Committee sponsored a second Biorepository Working Group to complete the list of preanalytic variables for annotating biospecimens. Members of the second Biorepository Working Group are experts in clinical pathology and microbiology. Additional preanalytic area-specific variables were identified and ranked along with definitions and potential negative impacts if the variable is not attached to the biospecimen. The draft manuscript was reviewed by additional national and international stakeholders. Four additional required preanalytic variables were identified specifically for clinical chemistry and microbiology biospecimens that can be used as a guide for site-specific implementation into patient care and research biorepository processes. In our collective experience, selecting which of the many preanalytic variables to attach to any specific set of biospecimens used for patient care and/or research is often difficult. The additional ranked list should be of practical benefit when selecting preanalytic variables for a given biospecimen collection.

Clinical and translational scientist career success: metrics for evaluation.

PubMed

Lee, Linda S; Pusek, Susan N; McCormack, Wayne T; Helitzer, Deborah L; Martina, Camille A; Dozier, Ann M; Ahluwalia, Jasjit S; Schwartz, Lisa S; McManus, Linda M; Reynolds, Brian D; Haynes, Erin N; Rubio, Doris M

2012-10-01

Despite the increased emphasis on formal training in clinical and translational research and the growth in the number and scope of training programs over the past decade, the impact of training on research productivity and career success has yet to be fully evaluated at the institutional level. In this article, the Education Evaluation Working Group of the Clinical and Translational Science Award Consortium introduces selected metrics and methods associated with the assessment of key factors that affect research career success. The goals in providing this information are to encourage more consistent data collection across training sites, to foster more rigorous and systematic exploration of factors associated with career success, and to help address previously identified difficulties in program evaluation. © 2012 Wiley Periodicals, Inc.

Pediatric oncology clinical trial participation where the geography is vast: Development of a clinical research system for tertiary and satellite centers in Ontario, Canada.

PubMed

Alexander, Sarah; Greenberg, Mark; Malkin, David; Portwine, Carol; Johnston, Donna; Silva, Mariana; Zelcer, Shayna; Sonshine, Samantha; Manzo, Janet; Bennett, Carla; Brodeur-Robb, Kathy; Deveault, Catherine; Ramachandran, Nivetha; Gibson, Paul

2018-04-01

Opportunities for participation in clinical trials are a core component of the care of children with cancer. In Ontario, many pediatric patients live long distances from their cancer center. This paper describes the work that was done in order to allow patients participating in Children's Oncology Group trials to receive care, including research protocol related care, jointly between the tertiary pediatric cancer center and the closer-to-home satellite center. The system is a pragmatic risk-based model, supporting excellence in care while ensuring good conduct of the research in compliance with applicable regulations and guidelines, including ethics oversight. © 2017 Wiley Periodicals, Inc.

Common data elements for clinical research in mitochondrial disease: a National Institute for Neurological Disorders and Stroke project.

PubMed

Karaa, Amel; Rahman, Shamima; Lombès, Anne; Yu-Wai-Man, Patrick; Sheikh, Muniza K; Alai-Hansen, Sherita; Cohen, Bruce H; Dimmock, David; Emrick, Lisa; Falk, Marni J; McCormack, Shana; Mirsky, David; Moore, Tony; Parikh, Sumit; Shoffner, John; Taivassalo, Tanja; Tarnopolsky, Mark; Tein, Ingrid; Odenkirchen, Joanne C; Goldstein, Amy

2017-05-01

The common data elements (CDE) project was developed by the National Institute of Neurological Disorders and Stroke (NINDS) to provide clinical researchers with tools to improve data quality and allow for harmonization of data collected in different research studies. CDEs have been created for several neurological diseases; the aim of this project was to develop CDEs specifically curated for mitochondrial disease (Mito) to enhance clinical research. Nine working groups (WGs), composed of international mitochondrial disease experts, provided recommendations for Mito clinical research. They initially reviewed existing NINDS CDEs and instruments, and developed new data elements or instruments when needed. Recommendations were organized, internally reviewed by the Mito WGs, and posted online for external public comment for a period of eight weeks. The final version was again reviewed by all WGs and the NINDS CDE team prior to posting for public use. The NINDS Mito CDEs and supporting documents are publicly available on the NINDS CDE website ( https://commondataelements.ninds.nih.gov/ ), organized into domain categories such as Participant/Subject Characteristics, Assessments, and Examinations. We developed a comprehensive set of CDE recommendations, data definitions, case report forms (CRFs), and guidelines for use in Mito clinical research. The widespread use of CDEs is intended to enhance Mito clinical research endeavors, including natural history studies, clinical trial design, and data sharing. Ongoing international collaboration will facilitate regular review, updates and online publication of Mito CDEs, and support improved consistency of data collection and reporting.

Predicting Recovery Potential for Individual Stroke Patients Increases Rehabilitation Efficiency.

PubMed

Stinear, Cathy M; Byblow, Winston D; Ackerley, Suzanne J; Barber, P Alan; Smith, Marie-Claire

2017-04-01

Several clinical measures and biomarkers are associated with motor recovery after stroke, but none are used to guide rehabilitation for individual patients. The objective of this study was to evaluate the implementation of upper limb predictions in stroke rehabilitation, by combining clinical measures and biomarkers using the Predict Recovery Potential (PREP) algorithm. Predictions were provided for patients in the implementation group (n=110) and withheld from the comparison group (n=82). Predictions guided rehabilitation therapy focus for patients in the implementation group. The effects of predictive information on clinical practice (length of stay, therapist confidence, therapy content, and dose) were evaluated. Clinical outcomes (upper limb function, impairment and use, independence, and quality of life) were measured 3 and 6 months poststroke. The primary clinical practice outcome was inpatient length of stay. The primary clinical outcome was Action Research Arm Test score 3 months poststroke. Length of stay was 1 week shorter for the implementation group (11 days; 95% confidence interval, 9-13 days) than the comparison group (17 days; 95% confidence interval, 14-21 days; P =0.001), controlling for upper limb impairment, age, sex, and comorbidities. Therapists were more confident ( P =0.004) and modified therapy content according to predictions for the implementation group ( P <0.05). The algorithm correctly predicted the primary clinical outcome for 80% of patients in both groups. There were no adverse effects of algorithm implementation on patient outcomes at 3 or 6 months poststroke. PREP algorithm predictions modify therapy content and increase rehabilitation efficiency after stroke without compromising clinical outcome. URL: http://anzctr.org.au. Unique identifier: ACTRN12611000755932. © 2017 American Heart Association, Inc.

77 FR 35417 - Center for Scientific Review; Notice of Closed Meetings

Federal Register 2010, 2011, 2012, 2013, 2014

2012-06-13

... Committee: AIDS and Related Research Integrated Review Group; AIDS Molecular and Cellular Biology Study... . Name of Committee: Center for Scientific Review Special Emphasis Panel; Small Business: Orthopedic and... of Federal Domestic Assistance Program Nos. 93.306, Comparative Medicine; 93.333, Clinical Research...

Fundamentals and Catalytic Innovation: The Statistical and Data Management Center of the Antibacterial Resistance Leadership Group

PubMed Central

Huvane, Jacqueline; Komarow, Lauren; Hill, Carol; Tran, Thuy Tien T.; Pereira, Carol; Rosenkranz, Susan L.; Finnemeyer, Matt; Earley, Michelle; Jiang, Hongyu (Jeanne); Wang, Rui; Lok, Judith

2017-01-01

Abstract The Statistical and Data Management Center (SDMC) provides the Antibacterial Resistance Leadership Group (ARLG) with statistical and data management expertise to advance the ARLG research agenda. The SDMC is active at all stages of a study, including design; data collection and monitoring; data analyses and archival; and publication of study results. The SDMC enhances the scientific integrity of ARLG studies through the development and implementation of innovative and practical statistical methodologies and by educating research colleagues regarding the application of clinical trial fundamentals. This article summarizes the challenges and roles, as well as the innovative contributions in the design, monitoring, and analyses of clinical trials and diagnostic studies, of the ARLG SDMC. PMID:28350899

When Trust Is Not Enough: A Serial Mediation Model Explaining the Effect of Race Identity, eHealth Information Efficacy, and Information Behavior on Intention to Participate in Clinical Research.

PubMed

Strekalova, Yulia A

2018-02-01

Black participants remain significantly underrepresented in clinical research. Mistrust in medical researchers has been named a key barrier to the successful enrollment of minority study participants. However, trust is a social-interactional construct, and its effects on behavior are complex. This study hypothesized that intention to participate in clinical research is mediated by trust in medical researchers, eHealth literacy, and information seeking behavior. The data were collected through an online survey ( N = 340) and analyzed to identify serial mediation. The model showed insignificant direct effect of race identity on behavioral intention, c' = -0.19, t(335) = -1.22, p = .22, but a significant total effect, c = -0.44, t(335) = -2.59, p < .01. The indirect effect of race identity on behavioral intention was also significant. The positive effect of trust in medical researchers on decisions to participate in clinical research can be amplified by stronger eHealth literacy and active information seeking, which can be supported through focused strategic health education and communication interventions. A focus on the development of information literacy that could provide prospective minority research volunteers with skills for informed decision making should be explored as an option for increasing mindful, informed participation in clinical research among currently underrepresented racial and ethnic groups.

Perceived challenges to obtaining informed consent for a time-sensitive emergency department study of pediatric status epilepticus: results of two focus groups.

PubMed

Chamberlain, James M; Lillis, Kathleen; Vance, Cheryl; Brown, Kathleen M; Fawumi, Olubunmi; Nichols, Shari; Davis, Colleen O; Singh, Tasmeen; Baren, Jill M

2009-08-01

The objective was to describe the perspective of research personnel on issues of informed consent in a time-sensitive clinical study under emergency circumstances. The authors convened concurrent focus groups of research staff and investigators involved in a pharmacokinetic study of lorazepam for status epilepticus (SE). Moderators led discussion with open-ended questions on selected issues of parental consent, communication and understanding, patient assent, and comparison to other types of studies. Focus group transcripts were analyzed to identify themes and subthemes from the discussions. Most themes and subthemes were identified in both research staff and investigator focus groups. Focus group discussion points were categorized into three main themes: barriers to and enablers of informed consent, barriers to and enablers of actual enrollment, and overall ethical concerns about the research. Many of the issues identified were unique to emergency research. From the perspectives of research staff and investigators enrolling patients in a time-sensitive emergency department study, the authors identified several areas of concern that should be addressed when planning future emergency studies.

Resident Physicians' Perspectives on Effective Outpatient Teaching: A Qualitative Study

ERIC Educational Resources Information Center

Kisiel, John B.; Bundrick, John B.; Beckman, Thomas J.

2010-01-01

Learning theories, which suggest that experienced faculty use collaborative teaching styles, are reflected in qualitative studies of learners in hospital settings. However, little research has used resident focus groups to explore characteristics of successful teachers in outpatient clinics. Therefore, focus group discussions with first through…

Expanding Public-Private Collaborations to Enhance Cancer Drug Development: A Report of the Institute of Medicine’s Workshop Series, “Implementing a National Cancer Clinical Trials System for the 21st Century”

PubMed Central

Canetta, Renzo; Nass, Sharyl J.

2014-01-01

Since their inception in the 1950s, the National Cancer Institute-funded cancer cooperative groups have been important contributors to cancer clinical and translational research. In 2010, a committee appointed by the Institute of Medicine (IOM) of the National Academy of Sciences completed a consensus review on the status of the U.S. publicly funded cancer clinical trials system. This report identified a need to reinvigorate the cooperative groups and provided recommendations for improving their effectiveness. Follow-up workshops to monitor progress were conducted by the IOM’s National Cancer Policy Forum and the American Society of Clinical Oncology (ASCO) in 2011 and 2013. One of the key recommendations of the IOM report was a call for greater collaboration among stakeholders in cancer research. In particular, more active engagement and better alignment of incentives among the cooperative groups, the National Cancer Institute, the U.S. Food and Drug Administration, and the biopharmaceutical industry were identified as essential to achieving the promise of oncology drug development. This review, based on presentations and discussion during the IOM-ASCO workshops, outlines the progress and remaining challenges of these collaborations. PMID:25326161

Expanding public-private collaborations to enhance cancer drug development: a report of the Institute of Medicine's workshop series, "Implementing a National Cancer Clinical Trials System for the 21st Century".

PubMed

Bertagnolli, Monica M; Canetta, Renzo; Nass, Sharyl J

2014-11-01

Since their inception in the 1950s, the National Cancer Institute-funded cancer cooperative groups have been important contributors to cancer clinical and translational research. In 2010, a committee appointed by the Institute of Medicine (IOM) of the National Academy of Sciences completed a consensus review on the status of the U.S. publicly funded cancer clinical trials system. This report identified a need to reinvigorate the cooperative groups and provided recommendations for improving their effectiveness. Follow-up workshops to monitor progress were conducted by the IOM's National Cancer Policy Forum and the American Society of Clinical Oncology (ASCO) in 2011 and 2013. One of the key recommendations of the IOM report was a call for greater collaboration among stakeholders in cancer research. In particular, more active engagement and better alignment of incentives among the cooperative groups, the National Cancer Institute, the U.S. Food and Drug Administration, and the biopharmaceutical industry were identified as essential to achieving the promise of oncology drug development. This review, based on presentations and discussion during the IOM-ASCO workshops, outlines the progress and remaining challenges of these collaborations. ©AlphaMed Press.

[Draft of Guidelines for Human Body Dissection for Clinical Anatomy Education and Research and commentary].

PubMed

Shichinohe, Toshiaki; Kondo, Satoshi; Ide, Chizuka; Higuchi, Norio; Aiso, Sadakazu; Sakai, Tatsuo; Matsumura, George; Yoshida, Kazunari; Kobayashi, Eiji; Tatsumi, Haruyuki; Yaginuma, Hiroyuki; Hishikawa, Shuji; Sugimoto, Maki; Izawa, Yoshimitsu; Imanishi, Nobuaki

2011-07-01

This article analyses the Draft of Guidelines for Human Body Dissection for Clinical Anatomy Education and Research drawn by the Study Group for Future Training Systems of Surgical Skills and Procedures established by the Fiscal Year 2010 research program of the Ministry of Health, Labor and Welfare. The purpose of the Draft of Guidelines is: First, to lay out the required basic guidelines for human cadaver usage to allow medical and dental faculty to conduct clinical education and research in accordance with existing regulations. Second, the guidelines are expected to give physicians a regulatory framework to carry out cadaver training in accordance with the current legal framework. This article explains the Draft of Guidelines in detail, outlines the future of cadaver training, and describes issues which must still be solved.

[Draft of guidelines for human body dissection for clinical anatomy education and research and commentary].

PubMed

Shichinohe, Toshiaki; Kondo, Satoshi; Ide, Chizuka; Higuchi, Norio; Aiso, Sadakazu; Sakai, Tatsuo; Matsumura, George; Yoshida, Kazunari; Kobayashi, Eiji; Tatsumi, Haruyuki; Yaginuma, Hiroyuki; Hishikawa, Shuji; Sugimoto, Maki; Izawa, Yoshimitsu; Imanishi, Nobuaki

2011-06-01

This article analyses the Draft of Guidelines for Human Body Dissection for Clinical Anatomy Education and Research drawn by the Study Group for Future Training Systems of Surgical Skills and Procedures established by the Fiscal Year 2010 research program of the Ministry of Health, Labor and Welfare. The purpose of the Draft of Guidelines is: First, to lay out the required basic guidelines for human cadaver usage to allow medical and dental faculty to conduct clinical education and research in accordance with existing regulations. Second, the guidelines are expected to give physicians a regulatory framework to carry out cadaver training in accordance with the current legal framework. This article explains the Draft of Guidelines in detail, outlines the future of cadaver training, and describes issues which must still be solved.

Resistance to group clinical supervision: A semistructured interview study of non-participating mental health nursing staff members.

PubMed

Buus, Niels; Delgado, Cynthia; Traynor, Michael; Gonge, Henrik

2018-04-01

This present study is a report of an interview study exploring personal views on participating in group clinical supervision among mental health nursing staff members who do not participate in supervision. There is a paucity of empirical research on resistance to supervision, which has traditionally been theorized as a supervisee's maladaptive coping with anxiety in the supervision process. The aim of the present study was to examine resistance to group clinical supervision by interviewing nurses who did not participate in supervision. In 2015, we conducted semistructured interviews with 24 Danish mental health nursing staff members who had been observed not to participate in supervision in two periods of 3 months. Interviews were audio-recorded and subjected to discourse analysis. We constructed two discursive positions taken by the informants: (i) 'forced non-participation', where an informant was in favour of supervision, but presented practical reasons for not participating; and (ii) 'deliberate rejection', where an informant intentionally chose to not to participate in supervision. Furthermore, we described two typical themes drawn upon by informants in their positioning: 'difficulties related to participating in supervision' and 'limited need for and benefits from supervision'. The findings indicated that group clinical supervision extended a space for group discussion that generated or accentuated anxiety because of already-existing conflicts and a fundamental lack of trust between group members. Many informants perceived group clinical supervision as an unacceptable intrusion, which could indicate a need for developing more acceptable types of post-registration clinical education and reflective practice for this group. © 2017 Australian College of Mental Health Nurses Inc.

Clinical research: assessing the future in a changing environment; summary report of conference sponsored by the American Medical Association Council on Scientific Affairs, Washington, DC, March 1996.

PubMed

Meyer, M; Genel, M; Altman, R D; Williams, M A; Allen, J R

1998-03-01

Concerns about funding of clinical research underlie all other problems identified at the Council on Scientific Affairs conference. Future National Institutes of Health (NIH) budgets are likely to be constant at best, and the general public expects cost containment to be an ongoing goal; this is exacerbated by the impending Medicare Trust Fund crisis. Meanwhile, traditional financial support of clinical research in academic medical centers (AMCs) through cross-subsidization is imperiled by competitive pressures largely caused by managed care. Although managed care organizations (MCOs) are potentially rich sources of funding and other resources, and some not-for-profit companies are conducting some research, for-profit MCOs have not demonstrated an understanding of the importance of clinical research. Young physicians are being discouraged from careers as clinical researchers and established investigators are "dropping out" because of demands for clinical productivity and competition for research grants, loss of patients/research subjects to managed care, perceived lack of status and compensation, and overall uncertainty about continued financial support. Efforts to assist current and potential clinical investigators are discussed in this report. Loss of patients, denial of reimbursement, and competition with MCOs and contract research organizations (CROs) have placed AMCs under unprecedented pressure. However, research centers located in AMCs have allowed investigators to conduct clinical research by providing a "protected environment." Furthermore, many AMCs are determined to continue conducting clinical research and are addressing related problems. Although the NIH will continue to be a major source of funding for clinical research, partnerships between various private and public entities provide important opportunities to maximize the productivity of all individuals and institutions involved. Potential partnerships include MCOs, AMCs, CROs, pharmaceutical companies and other industry, the Department of Defense, the Veterans Health Administration, practice-based physicians, and private foundations and patient support groups. "Partnerships in advocacy" for clinical research will be essential. Efforts to recruit for-profit MCOs to the clinical research endeavor identified in this report include (1) emphasizing issues of interest to them (eg, outcomes research); (2) stressing the significance of some research to the marketplace; (3) developing criteria to distinguish individual MCOs on the basis of their contribution to the public interest; (4) equating money spent on research with "R&D dollars" spent in nonmedical business enterprises; and (5) educating purchasers of health care (eg, corporate health plan directors) about clinical research. Conducting clinical research in all managed care settings requires leadership, the understanding and cooperation of physicians and support staff, wise use of limited resources (ie, funding only the best research projects), sound methodology, and above all, the perception that the research will ultimately improve patient care.

[Does impact factor influence the ethics of the instructions provided to journal authors?].

PubMed

Teixeira, Renan Kleber Costa; Yamaki, Vitor Nagai; Gonçalves, Thiago Barbosa; Botelho, Nara Macedo; Silva, José Antonio Cordero da

2013-01-01

Verify whether a journal's impact factor is a mechanism that modifies the ethical requirements described in the instructions provided to authors of articles published in Brazilian medical journals. 48 selected journals were divided into two groups: impact-factor (n=24), and no-impact-factor (n=24). The number of ethical requirements was compared between both groups based on a specific research protocol, ranging from zero to six points, analyzing the presence of an approval by a research ethics committee; reference to the fact that the research follows the precepts of the Declaration of Helsinki and the rules of Resolution 196/96; use of an informed consent; information about the authors' conflicts of interest; and a request for registration of clinical trials in the Brazilian Clinical Trials Registry. The average score of the impact-factor group was significantly higher than that of the no-impact-factor group (3.12 ± 1.03 vs. 2.08 ± 1.64, p=0.0121). When each ethical requirement was compared between the groups, there was significant difference only between the requirement of an informed consent and the disclosure of conflicts of interest (p < 0.05). The impact factor is a determinant factor on the ethics included in the instructions to authors of articles in scientific journals, showing that higher-quality journals seek better-designed articles that are conscientious at the beginning of the research. Copyright © 2013 Elsevier Editora Ltda. All rights reserved.

Adapting a Program to Inform African American and Hispanic American Women About Cancer Clinical Trials

PubMed Central

Gonzalez, Jenny; Mumman, Manpreet; Cullen, Lisa; LaHousse, Sheila F.; Malcarne, Vanessa; Conde, Viridiana; Riley, Natasha

2010-01-01

The dearth of evidence-based clinical trial education programs may contribute to the underrepresentation of African American and Hispanic American women in cancer research studies. This study used focus group-derived data from 80 women distributed among eight Spanish- and English-language focus groups. These data guided the researchers’ adaptation and refinement of the National Cancer Institute’s various clinical trials education programs into a program that was specifically focused on meeting the information needs of minority women and addressing the barriers to study participation that they perceived. A “sisterhood” theme was adopted and woven throughout the presentation. PMID:20146043

The John Milner Nutrition and Cancer Prevention Research Practicum | Division of Cancer Prevention

Cancer.gov

The Nutritional Science Research Group in the Division of Cancer Prevention at the National Cancer Institute, National Institutes of Health and the Department of Nutrition at the Clinical Center, National Institutes of Health, and the US Department of Agriculture's Beltsville Human Nutrition Research Center are offering a one week educational opportunity in "Nutrition and

Nutrition and Cancer Prevention Research Practicum | Division of Cancer Prevention

Cancer.gov

The Nutritional Science Research Group in the Division of Cancer Prevention at the National Cancer Institute, National Institutes of Health and the Department of Nutrition at the Clinical Center, National Institutes of Health are offering a one week educational opportunity in "Nutrition and Cancer Prevention Research" for individuals with a sustained commitment to nutrition

TU-E-BRB-00: Deformable Image Registration: Is It Right for Your Clinic

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

NONE

2015-06-15

Deformable image registration (DIR) is developing rapidly and is poised to substantially improve dose fusion accuracy for adaptive and retreatment planning and motion management and PET fusion to enhance contour delineation for treatment planning. However, DIR dose warping accuracy is difficult to quantify, in general, and particularly difficult to do so on a patient-specific basis. As clinical DIR options become more widely available, there is an increased need to understand the implications of incorporating DIR into clinical workflow. Several groups have assessed DIR accuracy in clinically relevant scenarios, but no comprehensive review material is yet available. This session will alsomore » discuss aspects of the AAPM Task Group 132 on the Use of Image Registration and Data Fusion Algorithms and Techniques in Radiotherapy Treatment Planning official report, which provides recommendations for DIR clinical use. We will summarize and compare various commercial DIR software options, outline successful clinical techniques, show specific examples with discussion of appropriate and inappropriate applications of DIR, discuss the clinical implications of DIR, provide an overview of current DIR error analysis research, review QA options and research phantom development and present TG-132 recommendations. Learning Objectives: Compare/contrast commercial DIR software and QA options Overview clinical DIR workflow for retreatment To understand uncertainties introduced by DIR Review TG-132 proposed recommendations.« less

The role of the nurse lecturer in clinical practice in the Republic of Ireland.

PubMed

McSharry, Edel; McGloin, Helen; Frizzell, Anne Marie; Winters-O'Donnell, Lisa

2010-07-01

Undergraduate nurse education in Ireland transferred into the third level sector in 2002. As a result nurse lecturers are expected to develop a model of clinical practice that enables them to be involved in practice and its development while maintaining their own nursing expertise and credibility [An Bord Altranais, 2005. Requirements and Standards for Nurse Registration Education Programmes, third ed. An Bord Altranais, Dublin]. In light of this the researchers set out to explore the perceptions of the nurse lecturers' role in clinical practice among nurse lecturers, preceptors, clinical nurse managers, clinical placement co-ordinators and students. A qualitative research design using focus groups was chosen. A purposive sampling strategy generated the sample for 5 in-depth focus group interviews with the aforementioned key stakeholders and the data was thematically analysed. Five themes emerged which centred on the maintenance of lecturers' clinical credibility, the lecturers' role as a resource to clinical staff, teaching and assessing students in practice, the value of fostering relationships in practice and role duplication. The findings from this study supports the anecdotal evidence that confusion exists around the role but more importantly it gives the nurse lecturer population guidance on how to develop the role in partnership with the various stakeholders in a way that supports the nursing students and clinical staff in practice in an effective manner. Copyright 2009 Elsevier Ltd. All rights reserved.

Independent but coordinated trials: insights from the practice-based Opportunities for Weight Reduction Trials Collaborative Research Group.

PubMed

Yeh, Hsin-Chieh; Clark, Jeanne M; Emmons, Karen E; Moore, Reneé H; Bennett, Gary G; Warner, Erica T; Sarwer, David B; Jerome, Gerald J; Miller, Edgar R; Volger, Sheri; Louis, Thomas A; Wells, Barbara; Wadden, Thomas A; Colditz, Graham A; Appel, Lawrence J

2010-08-01

The National Heart, Lung, and Blood Institute (NHLBI) funded three institutions to conduct effectiveness trials of weight loss interventions in primary care settings. Unlike traditional multi-center clinical trials, each study was established as an independent trial with a distinct protocol. Still, efforts were made to coordinate and standardize several aspects of the trials. The three trials formed a collaborative group, the 'Practice-based Opportunities for Weight Reduction (POWER) Trials Collaborative Research Group.' We describe the common and distinct features of the three trials, the key characteristics of the collaborative group, and the lessons learned from this novel organizational approach. The Collaborative Research Group consists of three individual studies: 'Be Fit, Be Well' (Washington University in St. Louis/Harvard University), 'POWER Hopkins' (Johns Hopkins), and 'POWER-UP' (University of Pennsylvania). There are a total of 15 participating clinics with ~1100 participants. The common primary outcome is change in weight at 24 months of follow-up, but each protocol has trial-specific elements including different interventions and different secondary outcomes. A Resource Coordinating Unit at Johns Hopkins provides administrative support. The Collaborative Research Group established common components to facilitate potential cross-site comparisons. The main advantage of this approach is to develop and evaluate several interventions, when there is insufficient evidence to test one or two approaches, as would be done in a traditional multi-center trial. The challenges of the organizational design include the complex decision-making process, the extent of potential data pooling, time intensive efforts to standardize reports, and the additional responsibilities of the DSMB to monitor three distinct protocols.

A qualitative study on acceptable levels of risk for pregnant women in clinical research.

PubMed

van der Zande, Indira S E; van der Graaf, Rieke; Oudijk, Martijn A; van Delden, Johannes J M

2017-05-15

There is ambiguity with regard to what counts as an acceptable level of risk in clinical research in pregnant women and there is no input from stakeholders relative to such research risks. The aim of our paper was to explore what stakeholders who are actively involved in the conduct of clinical research in pregnant women deem an acceptable level of risk for pregnant women in clinical research. Accordingly, we used the APOSTEL VI study, a low-risk obstetrical randomised controlled trial, as a case-study. We conducted a prospective qualitative study using 35 in-depth semi-structured interviews and one focus group. We interviewed healthcare professionals, Research Ethics Committee members (RECs) and regulators who are actively involved in the conduct of clinical research in pregnant women, in addition to pregnant women recruited for the APOSTEL VI case-study in the Netherlands. Three themes characterise the way stakeholders view risks in clinical research in pregnant women in general. Additionally, one theme characterises the way healthcare professionals and pregnant women view risks with respect to the case-study specifically. First, ideas on what constitutes an acceptable level of risk in general ranged from a preference for zero risk for the foetus up to minimal risk. Second, the desirability of clinical research in pregnant women in general was questioned altogether. Third, stakeholders proposed to establish an upper limit of risk in potentially beneficial clinical research in pregnant women in order to protect the foetus and the pregnant woman from harm. Fourth and finally, the case-study illustrates that healthcare professionals' individual perception of risk may influence recruitment. Healthcare professionals, RECs, regulators and pregnant women are all risk adverse in practice, possibly explaining the continuing underrepresentation of pregnant women in clinical research. Determining the acceptable levels of risk on a universal level alone is insufficient, because the individual perception of risk also influences behaviour towards pregnant women in clinical research. Therefore, bioethicists and researchers might be interested in changing the perception of risk, which could be achieved by education and awareness about the actual benefits and harms of inclusion and exclusion of pregnant women.

Perceptual Measurement in Schizophrenia: Promising Electrophysiology and Neuroimaging Paradigms From CNTRICS

PubMed Central

Butler, Pamela D.; Chen, Yue; Ford, Judith M.; Geyer, Mark A.; Silverstein, Steven M.; Green, Michael F.

2012-01-01

The sixth meeting of the Cognitive Neuroscience Treatment Research to Improve Cognition in Schizophrenia (CNTRICS) focused on selecting promising imaging paradigms for each of the cognitive constructs selected in the first CNTRICS meeting. In the domain of perception, the 2 constructs of interest were “gain control” and “visual integration.” CNTRICS received 6 task nominations for imaging paradigms for gain control and 3 task nominations for integration. The breakout group for perception evaluated the degree to which each of these tasks met prespecified criteria. For gain control, the breakout group believed that one task (mismatch negativity) was already mature and was being incorporated into multisite clinical trials. The breakout group recommended that 1 visual task (steady-state visual evoked potentials to magnocellular- vs parvocellular-biased stimuli) and 2 auditory measures (an event-related potential (ERP) measure of corollary discharge and a functional magnetic resonance imaging (fMRI) version of prepulse inhibition of startle) be adapted for use in clinical trials in schizophrenia research. For visual integration, the breakout group recommended that fMRI and ERP versions of a contour integration test and an fMRI version of a coherent motion test be adapted for use in clinical trials. This manuscript describes the ways in which each of these tasks met the criteria used in the breakout group to evaluate and recommend tasks for further development. PMID:21890745

Effects of Family-Center Empowerment Model on the Lifestyle of Heart Failure Patients: A Randomized Controlled Clinical Trial

PubMed Central

Rakhshan, Mahnaz; Kordshooli, Khadijeh Rahimi; Ghadakpoor, Soraya

2015-01-01

Background: Cardiovascular diseases are the most prevalent disorders in developed countries and heart failure is the major one among them. This disease is caused by numerous factors and one of the most considerable risk factors is unhealthy lifestyle. So the aim of this research was to study the effect of family-center empowerment model on the lifestyle of heart failure patients. Methods: This is a randomized controlled clinical trial on 70 heart failure patients referring to Hazrate Fatemeh heart clinic in Shiraz. After convenience sampling the patients were divided into two control and intervention groups using block randomization Method. The intervention based on family-center empowerment model was performed during 5 sessions. Research tools are lifestyle and demographic information questionnaires. Results: Both intervention and control groups were similar regarding their demographic information (P>0.001). Before the intervention on lifestyle, all measures of the two groups were equal (P>0.001) but after the intervention; statistically significant differences were reported in all dimensions of lifestyle, the total lifestyle score in the intervention group was 70.09±16.38 and in the control group -6.03±16.36 (P<0.001). Conclusion: Performing the family-center empowerment model for heart failure patients is practically possible, leading to improvement or refinement of their and their families’ lifestyle. Trial Registration Number: IRCT 2014072018468N3 PMID:26448952

Clinical Databases for Chest Physicians.

PubMed

Courtwright, Andrew M; Gabriel, Peter E

2018-04-01

A clinical database is a repository of patient medical and sociodemographic information focused on one or more specific health condition or exposure. Although clinical databases may be used for research purposes, their primary goal is to collect and track patient data for quality improvement, quality assurance, and/or actual clinical management. This article aims to provide an introduction and practical advice on the development of small-scale clinical databases for chest physicians and practice groups. Through example projects, we discuss the pros and cons of available technical platforms, including Microsoft Excel and Access, relational database management systems such as Oracle and PostgreSQL, and Research Electronic Data Capture. We consider approaches to deciding the base unit of data collection, creating consensus around variable definitions, and structuring routine clinical care to complement database aims. We conclude with an overview of regulatory and security considerations for clinical databases. Copyright © 2018 American College of Chest Physicians. Published by Elsevier Inc. All rights reserved.

[Surgical research in Germany. Organization, quality and international competitiveness].

PubMed

Menger, M D; Laschke, M W

2012-04-01

Surgical research in Germany is performed within surgical clinics by individual working groups or in surgical research divisions. Additionally, a few independent institutes and departments of surgical research have been established at medical faculties. The number of these institutions, however, is too small. To increase productivity in surgical research, structural changes are necessary, including additional establishment of further institutes and professorships. The quality of clinical research in surgery in Germany is critically discussed. International comparison shows that Germany has a low ranking with respect to the number of clinical studies published in leading surgical journals. However, there has been some improvement in the quality of clinical studies performed in surgical departments during the last 15 years. The establishment of the study center of the German Society of Surgery shows that excellent clinical studies with adequate numbers of patients can also be performed in Germany and can be published in leading journals. Accordingly, there is need to distribute the structures and the competence necessary to perform clinical studies in a standardized manner to all surgical departments involved in clinical research. The experimental surgical research in Germany is not adequately visible, although over the last 10 years the most relevant publications from institutions for surgical research have been placed in journals with a mean impact factor of 8. This may be due to the fact that 85% of these top publications are published in non-surgical journals. The aim for the future must therefore be to increase the impact factor and, thus, the attractiveness of surgical journals. This may be achieved by publishing the highest quality results from experimental surgical research not in non-surgical but in surgical journals.

Efficacy and safety of a multifactor intervention to improve therapeutic adherence in patients with chronic obstructive pulmonary disease (COPD): protocol for the ICEPOC study.

PubMed

Barnestein-Fonseca, Pilar; Leiva-Fernández, José; Vidal-España, Francisca; García-Ruiz, Antonio; Prados-Torres, Daniel; Leiva-Fernández, Francisca

2011-02-14

Low therapeutic adherence to medication is very common. Clinical effectiveness is related to dose rate and route of administration and so poor therapeutic adherence can reduce the clinical benefit of treatment. The therapeutic adherence of patients with chronic obstructive pulmonary disease (COPD) is extremely poor according to most studies. The research about COPD adherence has mainly focussed on quantifying its effect, and few studies have researched factors that affect non-adherence. Our study will evaluate the effectiveness of a multifactor intervention to improve the therapeutic adherence of COPD patients. A randomized controlled clinical trial with 140 COPD diagnosed patients selected by a non-probabilistic method of sampling. Subjects will be randomly allocated into two groups, using the block randomization technique. Every patient in each group will be visited four times during the year of the study. Motivational aspects related to adherence (beliefs and behaviour): group and individual interviews; cognitive aspects: information about illness; skills: inhaled technique training. Reinforcement of the cognitive-emotional aspects and inhaled technique training will be carried out in all visits of the intervention group. Adherence to a prescribed treatment involves a behavioural change. Cognitive, emotional and motivational aspects influence this change and so we consider the best intervention procedure to improve adherence would be a cognitive and emotional strategy which could be applied in daily clinical practice. Our hypothesis is that the application of a multifactor intervention (COPD information, dose reminders and reinforcing audiovisual material, motivational aspects and inhalation technique training) to COPD patients taking inhaled treatment will give a 25% increase in the number of patients showing therapeutic adherence in this group compared to the control group.We will evaluate the effectiveness of this multifactor intervention on patient adherence to inhaled drugs considering that it will be right and feasible to the clinical practice context. Current Controlled Trials ISRCTN18841601.

Priority setting partnership to identify the top 10 research priorities for the management of Parkinson's disease.

PubMed

Deane, Katherine H O; Flaherty, Helen; Daley, David J; Pascoe, Roland; Penhale, Bridget; Clarke, Carl E; Sackley, Catherine; Storey, Stacey

2014-12-14

This priority setting partnership was commissioned by Parkinson's UK to encourage people with direct and personal experience of the condition to work together to identify and prioritise the top 10 evidential uncertainties that impact on everyday clinical practice for the management of Parkinson's disease (PD). The UK. Anyone with experience of PD including: people with Parkinson's (PwP), carers, family and friends, healthcare and social care professionals. Non-clinical researchers and employees of pharmaceutical or medical devices companies were excluded. 1000 participants (60% PwP) provided ideas on research uncertainties, 475 (72% PwP) initially prioritised them and 27 (37% PwP) stakeholders agreed a final top 10. Using a modified nominal group technique, participants were surveyed to identify what issues for the management of PD needed research. Unique research questions unanswered by current evidence were identified and participants were asked to identify their top 10 research priorities from this list. The top 26 uncertainties were presented to a consensus meeting with key stakeholders to agree the top 10 research priorities. 1000 participants provided 4100 responses, which contained 94 unique unanswered research questions that were initially prioritised by 475 participants. A consensus meeting with 27 stakeholders agreed the top 10 research priorities. The overarching research aspiration was an effective cure for PD. The top 10 research priorities for PD management included the need to address motor symptoms (balance and falls, and fine motor control), non-motor symptoms (sleep and urinary dysfunction), mental health issues (stress and anxiety, dementia and mild cognitive impairments), side effects of medications (dyskinesia) and the need to develop interventions specific to the phenotypes of PD and better monitoring methods. These research priorities identify crucial gaps in the existing evidence to address everyday practicalities in the management of the complexities of PD. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

Analysis of professional competencies for the clinical research data management profession: implications for training and professional certification.

PubMed

Zozus, Meredith N; Lazarov, Angel; Smith, Leigh R; Breen, Tim E; Krikorian, Susan L; Zbyszewski, Patrick S; Knoll, Shelly K; Jendrasek, Debra A; Perrin, Derek C; Zambas, Demetris N; Williams, Tremaine B; Pieper, Carl F

2017-07-01

To assess and refine competencies for the clinical research data management profession. Based on prior work developing and maintaining a practice standard and professional certification exam, a survey was administered to a captive group of clinical research data managers to assess professional competencies, types of data managed, types of studies supported, and necessary foundational knowledge. Respondents confirmed a set of 91 professional competencies. As expected, differences were seen in job tasks between early- to mid-career and mid- to late-career practitioners. Respondents indicated growing variability in types of studies for which they managed data and types of data managed. Respondents adapted favorably to the separate articulation of professional competencies vs foundational knowledge. The increases in the types of data managed and variety of research settings in which data are managed indicate a need for formal education in principles and methods that can be applied to different research contexts (ie, formal degree programs supporting the profession), and stronger links with the informatics scientific discipline, clinical research informatics in particular. The results document the scope of the profession and will serve as a foundation for the next revision of the Certified Clinical Data Manager TM exam. A clear articulation of professional competencies and necessary foundational knowledge could inform the content of graduate degree programs or tracks in areas such as clinical research informatics that will develop the current and future clinical research data management workforce. © The Author 2017. Published by Oxford University Press on behalf of the American Medical Informatics Association. All rights reserved. For Permissions, please email: journals.permissions@oup.com

Validation in the clinical process: four settings for objectification of the subjectivity of understanding.

PubMed

Beland, H

1994-12-01

Clinical material is presented for discussion with the aim of exemplifying the author's conceptions of validation in a number of sessions and in psychoanalytic research and of making them verifiable, susceptible to consensus and/or falsifiable. Since Freud's postscript to the Dora case, the first clinical validation in the history of psychoanalysis, validation has been group-related and society-related, that is to say, it combines the evidence of subjectivity with the consensus of the research community (the scientific community). Validation verifies the conformity of the unconscious transference meaning with the analyst's understanding. The deciding criterion is the patient's reaction to the interpretation. In terms of the theory of science, validation in the clinical process corresponds to experimental testing of truth in the sphere of inanimate nature. Four settings of validation can be distinguished: the analyst's self-supervision during the process of understanding, which goes from incomprehension to comprehension (container-contained, PS-->D, selected fact); the patient's reaction to the interpretation (insight) and the analyst's assessment of the reaction; supervision and second thoughts; and discussion in groups and publications leading to consensus. It is a peculiarity of psychoanalytic research that in the event of positive validation the three criteria of truth (evidence, consensus and utility) coincide.

Clinical relevance of the effects of reach-to-grasp training using trunk restraint in individuals with hemiparesis poststroke: A systematic review.

PubMed

Greisberger, Andrea; Aviv, Hanna; Garbade, Sven F; Diermayr, Gudrun

2016-04-28

To evaluate the evidence for, and clinical relevance of, immediate and long-term effects of trunk restraint during reach-to-grasp training poststroke on movement patterns and functional abilities within the framework of the International Classification of Functioning, Disability and Health. PubMed, Web of Science, CINAHL, Embase, PEDro, Cochrane Library (publication dates January 1985 to March 2015). Randomized controlled trials comparing training using trunk restraint with any other exercise training. Data were extracted by one researcher and checked by two other researchers. The Cochrane Collaboration's tool for assessing risk of bias and the Physiotherapy Evidence Database scale were used by two researchers to assess study quality and risk of bias. Eight studies met the inclusion criteria. Five studies found better recovery of movement patterns (trunk displacement, elbow extension, and/or shoulder flexion - body function/structure) at post-test in the experimental compared with the control groups. Functional abilities (activity/participation) improved more in the experimental groups in 3 studies at post-test. Long-term effects were found in one study after 4 weeks. Trunk restraint has immediate and some long-term effects in adults with chronic stroke. However, these effects are not consistently clinically relevant when referring to minimal detectable change or minimal clinically important difference values.

Factors That Advance and Restrict Programme Change and Professional Development in Dental Education

ERIC Educational Resources Information Center

Behar-Horenstein, Linda S.; Roberts, Kellie W.; Zafar, Mueen A.

2013-01-01

The aim of this study was to explore the effectiveness of a professional development initiative using organisational change research studies to frame the inquiry. Two faculty groups and two student groups participated in a total of four focus group interviews to ascertain their perceptions of a new model of pre-clinical dental education. Using a…

Incorporating ethical principles into clinical research protocols: a tool for protocol writers and ethics committees

PubMed Central

Li, Rebecca H; Wacholtz, Mary C; Barnes, Mark; Boggs, Liam; Callery-D'Amico, Susan; Davis, Amy; Digilova, Alla; Forster, David; Heffernan, Kate; Luthin, Maeve; Lynch, Holly Fernandez; McNair, Lindsay; Miller, Jennifer E; Murphy, Jacquelyn; Van Campen, Luann; Wilenzick, Mark; Wolf, Delia; Woolston, Cris; Aldinger, Carmen; Bierer, Barbara E

2016-01-01

A novel Protocol Ethics Tool Kit (‘Ethics Tool Kit’) has been developed by a multi-stakeholder group of the Multi-Regional Clinical Trials Center of Brigham and Women's Hospital and Harvard. The purpose of the Ethics Tool Kit is to facilitate effective recognition, consideration and deliberation of critical ethical issues in clinical trial protocols. The Ethics Tool Kit may be used by investigators and sponsors to develop a dedicated Ethics Section within a protocol to improve the consistency and transparency between clinical trial protocols and research ethics committee reviews. It may also streamline ethics review and may facilitate and expedite the review process by anticipating the concerns of ethics committee reviewers. Specific attention was given to issues arising in multinational settings. With the use of this Tool Kit, researchers have the opportunity to address critical research ethics issues proactively, potentially speeding the time and easing the process to final protocol approval. PMID:26811365

Research design considerations for confirmatory chronic pain clinical trials: IMMPACT recommendations.

PubMed

Dworkin, Robert H; Turk, Dennis C; Peirce-Sandner, Sarah; Baron, Ralf; Bellamy, Nicholas; Burke, Laurie B; Chappell, Amy; Chartier, Kevin; Cleeland, Charles S; Costello, Ann; Cowan, Penney; Dimitrova, Rozalina; Ellenberg, Susan; Farrar, John T; French, Jacqueline A; Gilron, Ian; Hertz, Sharon; Jadad, Alejandro R; Jay, Gary W; Kalliomäki, Jarkko; Katz, Nathaniel P; Kerns, Robert D; Manning, Donald C; McDermott, Michael P; McGrath, Patrick J; Narayana, Arvind; Porter, Linda; Quessy, Steve; Rappaport, Bob A; Rauschkolb, Christine; Reeve, Bryce B; Rhodes, Thomas; Sampaio, Cristina; Simpson, David M; Stauffer, Joseph W; Stucki, Gerold; Tobias, Jeffrey; White, Richard E; Witter, James

2010-05-01

There has been an increase in the number of chronic pain clinical trials in which the treatments being evaluated did not differ significantly from placebo in the primary efficacy analyses despite previous research suggesting that efficacy could be expected. These findings could reflect a true lack of efficacy or methodological and other aspects of these trials that compromise the demonstration of efficacy. There is substantial variability among chronic pain clinical trials with respect to important research design considerations, and identifying and addressing any methodological weaknesses would enhance the likelihood of demonstrating the analgesic effects of new interventions. An IMMPACT consensus meeting was therefore convened to identify the critical research design considerations for confirmatory chronic pain trials and to make recommendations for their conduct. We present recommendations for the major components of confirmatory chronic pain clinical trials, including participant selection, trial phases and duration, treatment groups and dosing regimens, and types of trials. Increased attention to and research on the methodological aspects of confirmatory chronic pain clinical trials has the potential to enhance their assay sensitivity and ultimately provide more meaningful evaluations of treatments for chronic pain. Copyright 2010 International Association for the Study of Pain. All rights reserved.

Group processes in medical education: learning from social identity theory.

PubMed

Burford, Bryan

2012-02-01

The clinical workplace in which doctors learn involves many social groups, including representatives of different professions, clinical specialties and workplace teams. This paper suggests that medical education research does not currently take full account of the effects of group membership, and describes a theoretical approach from social psychology, the social identity approach, which allows those effects to be explored. The social identity approach has a long history in social psychology and provides an integrated account of group processes, from the adoption of group identity through a process of self-categorisation, to the biases and conflicts between groups. This paper outlines key elements of this theoretical approach and illustrates their relevance to medical education. The relevance of the social identity approach is illustrated with reference to a number of areas of medical education. The paper shows how research questions in medical education may be usefully reframed in terms of social identity in ways that allow a deeper exploration of the psychological processes involved. Professional identity and professionalism may be viewed in terms of self-categorisation rather than simply attainment; the salience of different identities may be considered as influences on teamwork and interprofessional learning, and issues in communication and assessment may be considered in terms of intergroup biases. Social identity theory provides a powerful framework with which to consider many areas of medical education. It allows disparate influences on, and consequences of, group membership to be considered as part of an integrated system, and allows assumptions, such as about the nature of professional identity and interprofessional tensions, to be made explicit in the design of research studies. This power to question assumptions and develop deeper and more meaningful research questions may be increasingly relevant as the nature and role of the medical profession change. © Blackwell Publishing Ltd 2012.

Towards an HIV cure: a global scientific strategy.

PubMed

Deeks, Steven G; Autran, Brigitte; Berkhout, Ben; Benkirane, Monsef; Cairns, Scott; Chomont, Nicolas; Chun, Tae-Wook; Churchill, Melissa; Di Mascio, Michele; Katlama, Christine; Lafeuillade, Alain; Landay, Alan; Lederman, Michael; Lewin, Sharon R; Maldarelli, Frank; Margolis, David; Markowitz, Martin; Martinez-Picado, Javier; Mullins, James I; Mellors, John; Moreno, Santiago; O'Doherty, Una; Palmer, Sarah; Penicaud, Marie-Capucine; Peterlin, Matija; Poli, Guido; Routy, Jean-Pierre; Rouzioux, Christine; Silvestri, Guido; Stevenson, Mario; Telenti, Amalio; Van Lint, Carine; Verdin, Eric; Woolfrey, Ann; Zaia, John; Barré-Sinoussi, Françoise

2012-07-20

Given the limitations of antiretroviral therapy and recent advances in our understanding of HIV persistence during effective treatment, there is a growing recognition that a cure for HIV infection is both needed and feasible. The International AIDS Society convened a group of international experts to develop a scientific strategy for research towards an HIV cure. Several priorities for basic, translational and clinical research were identified. This Opinion article summarizes the group's recommended key goals for the international community.

Characteristics of a French African Caribbean Epidemiological Psychiatric Sample with a History of Suicide Attempt

ERIC Educational Resources Information Center

Slama, Frederic; Dehurtevent, Benedicte; Even, Jean-Daniel; Charles-Nicolas, Aime; Ballon, Nicolas; Slama, Remy

2008-01-01

Research on vulnerability factors among ethnic groups, independent of primary psychiatric diagnosis, may help to identify groups at risk of suicidal behavior. French African Caribbean general psychiatric patients (N = 362) were recruited consecutively and independently of the primary psychiatric diagnosis. Demographic and clinical characteristics…

Multi-Family Group Therapy for Sexually Abusive Youth

ERIC Educational Resources Information Center

Nahum, David; Brewer, Marci Mandel

2004-01-01

Although Multi-Family Group Therapy (MFGT) has been a researched intervention for nearly 40 years, clinicians working with sexually abusive youth and their families have only more recently begun to utilize the intervention. We believe MFGT for a sexual offense-specific treatment population is a sophisticated and powerful clinical intervention with…

Vitamin D Supplementation for Prevention of Post-Traumatic Osteoarthritis: Evaluation in Animal and Clinical Models

DTIC Science & Technology

2016-10-25

Variation Group (Wolf JM, SVG group member). Variation in recommendation for surgical treatment for compressive neuropathy. J Hand Surg Am. 38(5):856...Orthopaedic Research and Education Foundation/ Goldberg Arthritis Grant Animal Model of Vitamin D Supplementation for Prevention of Osteoarthritis This

Establishing research priorities relating to the long-term impact of TIA and minor stroke through stakeholder-centred consensus.

PubMed

Turner, Grace M; Backman, Ruth; McMullan, Christel; Mathers, Jonathan; Marshall, Tom; Calvert, Melanie

2018-01-01

What is the problem and why is this important? Mini-strokes are similar to full strokes, but symptoms last less than 24 h. Many people (up to 70%) have long-term problems after a mini-stroke, such as anxiety; depression; problems with brain functioning (like memory loss); and fatigue (feeling tired). However, the current healthcare pathway only focuses on preventing another stroke and care for other long-term problems is not routinely given. Without proper treatment, people with long-term problems after a mini-stroke could have worse quality of life and may find it difficult to return to work and their social activities. What is the aim of the research? We wanted to understand the research priorities of patients, health care professionals and key stakeholders relating to the long-term impact of mini-stroke. How did we address the problem? We invited patients, clinicians, researchers and other stakeholders to attend a meeting. At the meeting people discussed the issues relating to the long-term impact of mini-stroke and came to an agreement on their research priorities. There were three stages: (1) people wrote down their individual research suggestions; (2) in smaller groups people came to an agreement on what their top research questions were; and (3) the whole group agreed final research priorities. What did we find? Eleven people attended who were representatives for patients, GPs, stroke consultants, stroke nurses, psychologists, the Stroke Association (charity) and stroke researchers, The group agreed on eleven research questions which they felt were the most important to improve health and well-being for people who have had a mini-stroke.The eleven research questions encompass a range of categories, including: understanding the existing care patients receive (according to diagnosis and geographical location); exploring what optimal care post-TIA/minor stroke should comprise (identifying and treating impairments, information giving and support groups) and how that care should be delivered (clinical setting and follow-up pathway); impact on family members; and education/training for health care professionals. Background Clinical management after transient ischaemic attack (TIA) and minor stroke focuses on stroke prevention. However, evidence demonstrates that many patients experience ongoing residual impairments. Residual impairments post-TIA and minor stroke may affect patients' quality of life and return to work or social activities. Research priorities of patients, health care professionals and key stakeholders relating to the long-term impact of TIA and minor stroke are unknown. Methods Our objective was to establish the top shared research priorities relating to the long-term impact of TIA and minor stroke through stakeholder-centred consensus. A one-day priority setting consensus meeting took place with representatives from different stakeholder groups in October 2016 (Birmingham, UK). Nominal group technique was used to establish research priorities. This involved three stages: (i) gathering research priorities from individual stakeholders; (ii) interim prioritisation in three subgroups; and (iii) final priority setting. Results The priority setting consensus meeting was attended by 11 stakeholders. The individual stakeholders identified 34 different research priorities. During the interim prioritisation exercise, the three subgroups generated 24 unique research priorities which were discussed as a whole group. Following the final consensus discussion, 11 shared research priorities were unanimously agreed.The 11 research questions encompass a range of categories, including: understanding the existing care patients receive (according to diagnosis and geographical location); exploring what optimal care post-TIA/minor stroke should comprise (identifying and treating impairments, information giving and support groups) and how that care should be delivered (clinical setting and follow-up pathway); impact on family members; and education/training for health care professionals. Conclusions Eleven different research priorities were established through stakeholder-centred consensus. These research questions could usefully inform the research agenda and policy decisions for TIA and minor stroke. Inclusion of stakeholders in setting research priorities is important to increase the relevance of research and reduce research waste.

Evaluation of Tuberculosis Diagnostics in Children: 1. Proposed Clinical Case Definitions for Classification of Intrathoracic Tuberculosis Disease. Consensus From an Expert Panel

PubMed Central

Graham, Stephen M.; Ahmed, Tahmeed; Amanullah, Farhana; Browning, Renee; Cardenas, Vicky; Casenghi, Martina; Cuevas, Luis E.; Gale, Marianne; Gie, Robert P.; Grzemska, Malgosia; Handelsman, Ed; Hatherill, Mark; Hesseling, Anneke C.; Jean-Philippe, Patrick; Kampmann, Beate; Kabra, Sushil Kumar; Lienhardt, Christian; Lighter-Fisher, Jennifer; Madhi, Shabir; Makhene, Mamodikoe; Marais, Ben J.; McNeeley, David F.; Menzies, Heather; Mitchell, Charles; Modi, Surbhi; Mofenson, Lynne; Musoke, Philippa; Nachman, Sharon; Powell, Clydette; Rigaud, Mona; Rouzier, Vanessa; Starke, Jeffrey R.; Swaminathan, Soumya; Wingfield, Claire

2012-01-01

There is a critical need for improved diagnosis of tuberculosis in children, particularly in young children with intrathoracic disease as this represents the most common type of tuberculosis in children and the greatest diagnostic challenge. There is also a need for standardized clinical case definitions for the evaluation of diagnostics in prospective clinical research studies that include children in whom tuberculosis is suspected but not confirmed by culture of Mycobacterium tuberculosis. A panel representing a wide range of expertise and child tuberculosis research experience aimed to develop standardized clinical research case definitions for intrathoracic tuberculosis in children to enable harmonized evaluation of new tuberculosis diagnostic technologies in pediatric populations. Draft definitions and statements were proposed and circulated widely for feedback. An expert panel then considered each of the proposed definitions and statements relating to clinical definitions. Formal group consensus rules were established and consensus was reached for each statement. The definitions presented in this article are intended for use in clinical research to evaluate diagnostic assays and not for individual patient diagnosis or treatment decisions. A complementary article addresses methodological issues to consider for research of diagnostics in children with suspected tuberculosis. PMID:22448023

Clinical trials as treatment option: bioethics and health care disparities in substance dependency.

PubMed

Timmermans, Stefan; McKay, Tara

2009-12-01

Bioethicists have warned against the dangers of mixing research with treatment. They are concerned that research priorities may take precedence over individual patient needs and that research subjects tend to misunderstand the purpose of research or overestimate the direct medical benefits of participating in studies. Yet, other work has questioned whether clinical research can always be separated from therapeutic benefit for participants. Using in-depth interviews with participants in two phase III randomized U.S. clinical trials for methamphetamine dependency, we examine the treatment options available to participants, their experiences with participating in the trials, and potential problems of trial participation. We find that while participants have experience with four alternative treatment modalities - quitting alone, support groups, in-patient treatment facilities, and consulting primary care physicians - the randomized clinical trials compare favorably to alternatives because they provide access to evidence-based behavioral treatments, specialized medical professionals, non-judgmental staff, and the possibility of receiving an experimental drug. We conclude that while randomized clinical trials are imperfect substitutes for clinical care, they constitute a fragile and sporadic therapeutic niche in a country with fundamental problems in access to health care, a mixed punitive-therapeutic drug addiction policy, and a profit-driven pharmaceutical development and approval process.

75 FR 4092 - Center for Scientific Review; Notice of Closed Meetings

Federal Register 2010, 2011, 2012, 2013, 2014

2010-01-26

...: Alzheimer's Disease Pilot Clinical Trials. Date: February 24, 2010. Time: 4 p.m. to 6 p.m. Agenda: To review... personal privacy. Name of Committee: Infectious Diseases and Microbiology Integrated Review Group, Clinical Research and Field Studies of Infectious Diseases Study Section. Date: February 15, 2010. Time: 8 a.m. to 6...

A Mixed Methodological Analysis of the Role of Culture in the Clinical Decision-Making Process

ERIC Educational Resources Information Center

Hays, Danica G.; Prosek, Elizabeth A.; McLeod, Amy L.

2010-01-01

Even though literature indicates that particular cultural groups receive more severe diagnoses at disproportionate rates, there has been minimal research that addresses how culture interfaces specifically with clinical decision making. This mixed methodological study of 41 counselors indicated that cultural characteristics of both counselors and…

Evaluation of the DSM-5 Severity Indicator for Bulimia Nervosa

PubMed Central

Grilo, Carlos M.; Ivezaj, Valentina; White, Marney A.

2015-01-01

This study examined the DSM-5 severity criterion for bulimia nervosa (BN) based on the frequency of inappropriate weight compensatory behaviors. 199 community volunteers classified with BN were categorized using DSM-5 severity levels and compared on demographic and clinical variables. 77 (39%) participants were categorized as mild, 68 (34%) as moderate, 32 (16%) as severe, and 22 (11%) as extreme. The severity groups did not differ significantly in demographic variables or body mass index. Shape and Weight concerns did not differ significantly across severity groups. Binge eating differed with the extreme group having higher frequency than the severe, moderate, and mild groups, which did not differ from each other. Restraint differed with the extreme group having significantly higher levels than the mild group. Eating concerns differed with the extreme group having higher levels than moderate and mild groups. Depression differed with the extreme group having higher levels than severe, moderate, and mild groups, which did not differ from each other. Findings from this non-clinical group provide new, albeit modest, support for DSM-5 severity rating for BN based on frequency of inappropriate weight compensatory behaviors. Statistical findings indicate that differences in collateral clinical variables associated with the DSM-5 severity ratings reflect small effect sizes. Further research is needed with treatment-seeking patient groups with BN to establish the validity of the DSM-5 severity specifier and should include broader clinical and functional validators. PMID:25744910

Evaluation of the DSM-5 severity indicator for bulimia nervosa.

PubMed

Grilo, Carlos M; Ivezaj, Valentina; White, Marney A

2015-04-01

This study examined the DSM-5 severity criterion for bulimia nervosa (BN) based on the frequency of inappropriate weight compensatory behaviors. 199 community volunteers classified with BN were categorized using DSM-5 severity levels and compared on demographic and clinical variables. 77 (39%) participants were categorized as mild, 68 (34%) as moderate, 32 (16%) as severe, and 22 (11%) as extreme. The severity groups did not differ significantly in demographic variables or body mass index. Shape and Weight concerns did not differ significantly across severity groups. Binge eating differed with the extreme group having significantly higher frequency than the severe, moderate, and mild groups, which did not differ from each other. Restraint differed with the extreme group having significantly higher levels than the mild group. Eating concerns differed with the extreme group having significantly higher levels than moderate and mild groups. Depression differed with the extreme group having significantly higher levels than severe, moderate, and mild groups, which did not differ from each other. Findings from this non-clinical group provide new, albeit modest, support for DSM-5 severity rating for BN based on frequency of inappropriate weight compensatory behaviors. Statistical findings indicate that differences in collateral clinical variables associated with the DSM-5 severity ratings reflect small effect sizes. Further research is needed with treatment-seeking patient groups with BN to establish the validity of the DSM-5 severity specifier and should include broader clinical and functional validators. Copyright © 2015 Elsevier Ltd. All rights reserved.

[Clinical research XVII. χ(2) test, from the expected to the observed].

PubMed

Rivas-Ruiz, Rodolfo; Castelán-Martínez, Osvaldo D; Pérez, Marcela; Talavera, Juan O

2013-01-01

When you want to show if there is a statistical association or differences between categorical variables, it is recommended to use the χ(2) test. This nonparametric test is one of the most used in clinical research; it contrasts nominal or ordinal qualitative variables that are observed in clinical practice. This test calculates the p value that determines whether differences between groups are real or due to chance. The χ(2) test is the basis of other tests to analyze qualitative ordinal variables as χ(2) for linear trend, which compares three groups with two outcomes or McNemar test, which contrasts two related samples (a before and afterward comparison) or Mantel-Haenszel χ(2), which controls for potential confounding variables. When using small samples, where the expected results are less than 5, Fisher's exact test should be used. These tests are the most widely used in the medical literature; however, they do not give us the magnitude or the direction of the event and a proper interpretation that requires clinical judgment is needed.

ESC Working Group Cellular Biology of the Heart: Position Paper: improving the preclinical assessment of novel cardioprotective therapies

PubMed Central

Lecour, Sandrine; Bøtker, Hans E.; Condorelli, Gianluigi; Davidson, Sean M.; Garcia-Dorado, David; Engel, Felix B.; Ferdinandy, Peter; Heusch, Gerd; Madonna, Rosalinda; Ovize, Michel; Ruiz-Meana, Marisol; Schulz, Rainer; Sluijter, Joost P.G.; Van Laake, Linda W.; Yellon, Derek M.; Hausenloy, Derek J.

2014-01-01

Ischaemic heart disease (IHD) remains the leading cause of death and disability worldwide. As a result, novel therapies are still needed to protect the heart from the detrimental effects of acute ischaemia–reperfusion injury, in order to improve clinical outcomes in IHD patients. In this regard, although a large number of novel cardioprotective therapies discovered in the research laboratory have been investigated in the clinical setting, only a few of these have been demonstrated to improve clinical outcomes. One potential reason for this lack of success may have been the failure to thoroughly assess the cardioprotective efficacy of these novel therapies in suitably designed preclinical experimental animal models. Therefore, the aim of this Position Paper by the European Society of Cardiology Working Group Cellular Biology of the Heart is to provide recommendations for improving the preclinical assessment of novel cardioprotective therapies discovered in the research laboratory, with the aim of increasing the likelihood of success in translating these new treatments into improved clinical outcomes. PMID:25344369

Periodontal soft tissue root coverage procedures: a consensus report from the AAP Regeneration Workshop.

PubMed

Tatakis, Dimitris N; Chambrone, Leandro; Allen, Edward P; Langer, Burton; McGuire, Michael K; Richardson, Christopher R; Zabalegui, Ion; Zadeh, Homayoun H

2015-02-01

Management of gingival recession defects, a common periodontal condition, using root coverage procedures is an important aspect of periodontal regenerative therapy. The goal of the periodontal soft tissue root coverage procedures group was to develop a consensus report based on the accompanying systematic review of root coverage procedures, including priorities for future research and identification of the best evidence available to manage different clinical scenarios. The group reviewed and discussed the accompanying systematic review, which covered treatment of single-tooth recession defects, multiple-tooth recession defects, and additional focused questions on relevant clinical topics. The consensus group members submitted additional material for consideration by the group in advance and at the time of the meeting. The group also identified priorities for future research. All reviewed root coverage procedures provide significant reduction in recession depth, especially for Miller Class I and II recession defects. Subepithelial connective tissue graft (SCTG) procedures provide the best root coverage outcomes. Acellular dermal matrix graft (ADMG) or enamel matrix derivative (EMD) in conjunction with a coronally advanced flap (CAF) can serve as alternatives to autogenous donor tissue. Additional research is needed to do the following: 1) assess the treatment outcomes for multiple-tooth recession defects, oral sites other than maxillary canine and premolar teeth, and Miller Class III and IV defects; 2) assess the role of patient- and site-specific factors on procedure outcomes; and 3) obtain evidence on patient-reported outcomes. Predictable root coverage is possible for single-tooth and multiple-tooth recession defects, with SCTG procedures providing the best root coverage outcomes. Alternatives to SCTG are supported by evidence of varying strength. Additional research is needed on treatment outcomes for specific oral sites. Clinical Recommendation: For Miller Class I and II single-tooth recession defects, SCTG procedures provide the best outcomes, whereas ADMG or EMD in conjunction with CAF may be used as an alternative.

The Ethics of Clinical Trials Research in Severe Mood Disorders.

PubMed

Nugent, Allison C; Miller, Franklin G; Henter, Ioline D; Zarate, Carlos A

2017-07-01

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.

Clinical outcomes of Joint Crisis Plans to reduce compulsory treatment for people with psychosis: a randomised controlled trial.

PubMed

Thornicroft, Graham; Farrelly, Simone; Szmukler, George; Birchwood, Max; Waheed, Waquas; Flach, Clare; Barrett, Barbara; Byford, Sarah; Henderson, Claire; Sutherby, Kim; Lester, Helen; Rose, Diana; Dunn, Graham; Leese, Morven; Marshall, Max

2013-05-11

The CRIMSON (CRisis plan IMpact: Subjective and Objective coercion and eNgagement) study is an individual level, randomised controlled trial that compared the effectiveness of Joint Crisis Plans (JCPs) with treatment as usual for people with severe mental illness. The JCP is a negotiated statement by a patient of treatment preferences for any future psychiatric emergency, when he or she might be unable to express clear views. We assessed whether the additional use of JCPs improved patient outcomes compared with treatment as usual. Patients were eligible if they had at least one psychiatric admission in the previous 2 years and were on the Enhanced Care Programme Approach register. The study was done with 64 generic and specialist community mental health teams in four English mental health care provider organisations (trusts). Hypotheses tested were that, compared with the control group, the intervention group would experience: fewer compulsory admissions (primary outcome); fewer psychiatric admissions; shorter psychiatric stays; lower perceived coercion; improved therapeutic relationships; and improved engagement. We stratified participants by centre. The research team but not participants nor clinical staff were masked to allocation. This study is registered with ClinicalTrials.gov, number ISRCTN11501328. 569 participants were randomly assigned (285 to the intervention group and 284 to the control group). No significant treatment effect was seen for the primary outcome (56 [20%] sectioned in the control group and 49 [18%] in the JCP group; odds ratio 0·90 [95% CI 0·58-1·39, p=0·63]) or any secondary outcomes, with the exception of an improved secondary outcome of therapeutic relationships (17·3 [7·6] vs 16·0 [7·1]; adjusted difference -1·28 [95% CI -2·56 to -0·01, p=0·049]). Qualitative data supported this finding. Our findings are inconsistent with two earlier JCP studies, and show that the JCP is not significantly more effective than treatment as usual. There is evidence to suggest the JCPs were not fully implemented in all study sites, and were combined with routine clinical review meetings which did not actively incorporate patients' preferences. The study therefore raises important questions about implementing new interventions in routine clinical practice. Medical Research Council UK and the National Institute for Health Research. Copyright © 2013 Elsevier Ltd. All rights reserved.

Improved informed consent documents for biomedical research do not increase patients’ understanding but reduce enrolment: a study in real settings

PubMed Central

Paris, Adeline; Deygas, Béatrice; Cornu, Catherine; Thalamas, Claire; Maison, Patrick; Duale, Christian; Kane, Maty; Hodaj, Enkelejda; Cracowski, Jean-Luc

2015-01-01

Aims The aim was to evaluate the comprehension of participants of an improved informed consent document (ICD). Method This was a randomized controlled French multicentre study performed in real conditions. Participants were adult patients undergoing screening for enrolment in biomedical research studies, who agreed to answer a validated questionnaire evaluating objective and subjective comprehension scored from 0 (no comprehension) to 100 (excellent comprehension). Patients were provided either the original ICD or an ICD modified in terms of structure and readability. The primary end point was the score of objective comprehension. The secondary end-points were the enrolment rate in the clinical study and patient characteristics associated with the score of objective comprehension. Results Four hundred and eighty-one patients were included, 241 patients in the original ICD group and 240 patients in the modified ICD group. There was no difference between the two groups for the score of objective comprehension (original ICD 72.7 (95% CI 71.3, 74.1) vs. modified ICD 72.5 (95% CI 71.0, 74.0); P = 0.81). However, the rate of enrolment in the clinical study was lower in the group who received the modified ICD (64.4% (95% CI 58.3, 70.5)) than for the original ICD (73.0% (95% CI 67.4, 78.7)) (P = 0.042). Only female gender and high educational level were associated with a better objective comprehension. Conclusions Improving ICDs had no effect on participants’ understanding, whereas the rate of enrolment was lower in this group. In attempts at improving potential participants’ understanding of clinical research information, efforts and future trials should focus on other ways to improve comprehension. PMID:26147763

Transparency and public involvement in animal research.

PubMed

Pound, Pandora; Blaug, Ricardo

2016-05-01

To be legitimate, research needs to be ethical, methodologically sound, of sufficient value to justify public expenditure and be transparent. Animal research has always been contested on ethical grounds, but there is now mounting evidence of poor scientific method, and growing doubts about its clinical value. So what of transparency? Here we examine the increasing focus on openness within animal research in the UK, analysing recent developments within the Home Office and within the main group representing the interests of the sector, Understanding Animal Research. We argue that, while important steps are being taken toward greater transparency, the legitimacy of animal research continues to be undermined by selective openness. We propose that openness could be increased through public involvement, and that this would bring about much needed improvements in animal research, as it has done in clinical research. 2016 FRAME.

The evolving professional identity of the clinical research nurse: A qualitative exploration.

PubMed

Kunhunny, Swapna; Salmon, Debra

2017-12-01

To examine the perspectives of CRNs in the UK on their professional role identity, in order to inform the professional practice of Clinical Research Nursing. Clinical research nurses (CRN) make a significant contribution to healthcare research within the UK and internationally. However, lack of clarity about their role, and scope of practice renders their contribution within the profession and in the minds of the wider public invisible. This has implications in terms of promoting the role nurses play not only in terms of recruitment, retention, and care of research participants but also as research leaders of the future. Exploratory qualitative design using thematic analysis conducted within a realist paradigm. Participants viewed the positive aspects of their identity 'as agents of change' who were fundamental to the clinical research process. Resourcefulness and the ability to guide members of the research team were valued as key to job satisfaction. Successful navigation through the complexity of advice, support, management and leadership tasks related to their role in caring for research patients were role affirming and generated a sense of pride. However, lack of recognition, clarity of the role and career development opportunities within an identified structure undermined the CRN identity and optimism about progression in the future. Participants reported feeling invisible to colleagues within the clinical community, isolated and excluded from wider nursing groups. The study describes UK CRN practice, highlighting the positive benefits and challenges associated with the role, including the need to support professional and career development to maximise their research contribution. This study provides nurses, health care and research organisations and academic nursing educators with a broadened understanding of the professional role, identity and context of clinical research nursing practice in the United Kingdom, with recommendations to improve its professional efficiency and recognition. © 2017 John Wiley & Sons Ltd.

RS/1 in the Clinical Environment

PubMed Central

Kush, Thomas

1980-01-01

This paper describes the design of RS/1,™ the Research System, and its use in clinical patient studies. RS/1 is an interactive computer software system developed by the Medical Systems Group at BBN. Investigators and technicians who have never before used computers can learn RS/1 with a few hours of training. It uses familiar and intuitive concepts for data handling and data analysis, such as the “automated notebook” format of data storage, the direct use of graphs in curve-fitting, and a simple command language. Its versatility has made RS/1 useful in clinical research contexts, especially for studies involving patient care data.

Combining clinical practice and academic work in nursing: A qualitative study about perceived importance, facilitators and barriers regarding clinical academic careers for nurses in university hospitals.

PubMed

van Oostveen, Catharina J; Goedhart, Nicole S; Francke, Anneke L; Vermeulen, Hester

2017-12-01

To obtain in-depth insight into the perceptions of nurse academics and other stakeholders regarding the importance, facilitators and barriers for nurses combining clinical and academic work in university hospitals. Combining clinical practice and academic work facilitates the use of research findings for high-quality patient care. However, nurse academics move away from the bedside because clinical academic careers for nurses have not yet been established in the Netherlands. This qualitative study was conducted in two Dutch university hospitals and their affiliated medical faculties and universities of applied sciences. Data were collected between May 2015 and August 2016. We used purposive sampling for 24 interviews. We asked 14 participants in two focus groups for their perceptions of importance, facilitators and barriers in nurses' combined clinical and academic work in education and research. We audiotaped, transcribed and thematically analysed the interviews and focus groups. Three themes related to perceived importance, facilitators and barriers: culture, leadership and infrastructure. These themes represent deficiencies in facilitating clinical academic careers for nurses. The current nursing culture emphasises direct patient care, which is perceived as an academic misfit. Leadership is lacking at all levels, resulting in the underuse of nurse academics and the absence of supporting structures for nurses who combine clinical and academic work. The present nursing culture appears to be the root cause of the dearth of academic positions and established clinical academic posts. A culture change would require a show of leadership that would promote and enable combined research, teaching and clinical practice and that would introduce clinical academic career pathways for nurses. Meanwhile, nurse academics should collaborate with established medical academics for whom combined roles are mainstream, and they should take advantage of their established infrastructure for success. © 2017 John Wiley & Sons Ltd.

Identifying appropriate reference data models for comparative effectiveness research (CER) studies based on data from clinical information systems.

PubMed

Ogunyemi, Omolola I; Meeker, Daniella; Kim, Hyeon-Eui; Ashish, Naveen; Farzaneh, Seena; Boxwala, Aziz

2013-08-01

The need for a common format for electronic exchange of clinical data prompted federal endorsement of applicable standards. However, despite obvious similarities, a consensus standard has not yet been selected in the comparative effectiveness research (CER) community. Using qualitative metrics for data retrieval and information loss across a variety of CER topic areas, we compare several existing models from a representative sample of organizations associated with clinical research: the Observational Medical Outcomes Partnership (OMOP), Biomedical Research Integrated Domain Group, the Clinical Data Interchange Standards Consortium, and the US Food and Drug Administration. While the models examined captured a majority of the data elements that are useful for CER studies, data elements related to insurance benefit design and plans were most detailed in OMOP's CDM version 4.0. Standardized vocabularies that facilitate semantic interoperability were included in the OMOP and US Food and Drug Administration Mini-Sentinel data models, but are left to the discretion of the end-user in Biomedical Research Integrated Domain Group and Analysis Data Model, limiting reuse opportunities. Among the challenges we encountered was the need to model data specific to a local setting. This was handled by extending the standard data models. We found that the Common Data Model from the OMOP met the broadest complement of CER objectives. Minimal information loss occurred in mapping data from institution-specific data warehouses onto the data models from the standards we assessed. However, to support certain scenarios, we found a need to enhance existing data dictionaries with local, institution-specific information.

A bibliometric analysis of digestive health research in Canada.

PubMed

Tuitt, Desiree; Knight, Frank; Lipman, Tara

2011-11-01

Measurement of the impact and influence of medical⁄scientific journals, and of individual researchers has become more widely practiced in recent decades. This is driven, in part, by the increased availability of data regarding citations of research articles, and by increased competition for research funding. Digestive disease research has been identified as a particularly strong discipline in Canada. The authors collected quantitative data on the impact and influence of Canadian digestive health research. The present study involved an analysis of the research impact (Hirsch factor) and research influence (Influence factor) of 106 digestive health researchers in Canada. Rankings of the top 25 researchers on the basis of the two metrics were dominated by the larger research groups at the University of Toronto (Toronto, Ontario), McMaster University (Hamilton, Ontario), and the Universities of Calgary (Calgary, Alberta) and Alberta (Edmonton, Alberta), but with representation by other research groups at the Universities of Manitoba (Winnipeg, Manitoba), Western Ontario (London, Ontario) and McGill University (Montreal, Quebec). Female and male researchers had similar scores for the two metrics, as did basic scientists versus clinical investigators. Strategic recruitment, particularly of established investigators, can have a major impact on the ranking of research groups. Comparing these metrics over different time frames can provide insights into the vulnerabilities and strengths of research groups.

Review of national research ethics regulations and guidelines in Middle Eastern Arab countries

PubMed Central

2012-01-01

Background Research ethics guidelines are essential for conducting medical research. Recently, numerous attempts have been made to establish national clinical research documents in the countries of the Middle East. This article analyzes these documents. Methods Thirteen Arab countries in the Middle East were explored for available national codes, regulations, and guidelines concerning research ethics, and 10 documents from eight countries were found. We studied these documents, considering the ethical principles stated in the Declaration of Helsinki, the Council for International Organizations of Medical Sciences (CIOMS) guidelines, and the International Conference of Harmonization - Guidelines for Good Clinical Practice (ICH-GCP). Our paper comprises a complete list of protections, such as confidentiality, informed consent, ethics committees, and others. Results This study found different levels and kinds of research ethics regulations and guidelines in the countries examined. Two groups can be distinguished: the countries in the first group have one or more research ethics regulations or guidelines, while the countries in the second group have not yet established any. Most of the documents showed various degrees of deficiencies in regard to ethical protection. The majority of the documents that were examined refer to one or more international documents on biomedical research ethics. Conclusions Recently, a lot of efforts have been made in many countries in the Middle East. However, compared with international documents, most of the research ethics documents in use in this region demonstrate numerous deficiencies. As it relates to these documents, extensive differences could be observed in regard to development, structure, content, and reference to international guidelines. PMID:23234422

Update on Outcome Measure Development for Large Vessel Vasculitis: Report from OMERACT 12

PubMed Central

Aydin, Sibel Zehra; Direskeneli, Haner; Sreih, Antoine; Alibaz-Oner, Fatma; Gul, Ahmet; Kamali, Sevil; Hatemi, Gulen; Kermani, Tanaz; Mackie, Sarah L.; Mahr, Alfred; Meara, Alexa; Milman, Nataliya; Nugent, Heidi; Robson, Joanna; Tomasson, Gunnar; Merkel, Peter A.

2015-01-01

Objective The rarity of large vessel vasculitis (LVV) is a major factor limiting randomized controlled trials in LVV, resulting in treatment choices in these diseases that are guided mainly by observational studies and expert opinion. Further complicating trials in LVV is the absence of validated and meaningful outcome measures. The Outcome Measures in Rheumatology (OMERACT) vasculitis working group initiated the Large Vessel Vasculitis task force in 2009 to develop data-driven, validated outcome tools for clinical investigation in LVV. This report summarizes the progress that has been made on a disease activity assessment tool and patient-reported outcomes in LVV as well as the group’s research agenda. Methods The OMERACT LVV task force brought an international group of investigators and patient research partners together to work collaboratively on developing outcome tools. The group initially focused on disease activity assessment tools in LVV. Following a systematic literature review, an international Delphi exercise was conducted to obtain expert opinion on principles and domains for disease assessment. The OMERACT vasculitis working group’s LVV task force is also conducting qualitative research with patients, including interviews, focus groups, and engaging patients as research partners, all to ensure that the approach to disease assessment includes measures of patients’ perspectives and that patients have input into the research agenda and process. Results The preliminary results of both the Delphi exercise and the qualitative interviews were discussed at the OMERACT 12 (2014) meeting and the completion of the analyses will produce an initial set of domains and instruments to form the basis of next steps in the research agenda. Conclusion The research agenda continues to evolve, with the ultimate goal of developing an OMERACT-endorsed core set of outcome measures for use in clinical trials of LVV. PMID:26077399

Designing clinically useful systems: examples from medicine and dentistry.

PubMed

Koch, S

2003-12-01

Despite promising results in medical informatics research and the development of a large number of different systems, few systems get beyond a prototype state and are really used in practice. Among other factors, the lack of explicit user focus is one main reason. The research projects presented in this paper follow a user-centered system development approach based on extensive work analyses in interdisciplinary working groups, taking into account human cognitive performance. Different medical and health-care specialists, together with researchers in human-computer interaction and medical informatics, specify future clinical work scenarios. Special focus is put on analysis and design of the information and communication flow and on exploration of intuitive visualization and interaction techniques for clinical information. Adequate choice of the technical access device is made depending on the user's work situation. It is the purpose of this paper to apply this method in two different research projects and thereby to show its potential for designing clinically useful systems that do support and not hamper clinical work. These research projects cover IT support for chairside work in dentistry (http://www.dis.uu.se/mdi/research/projects/orquest) and ICT support for home health care of elderly citizens (http://www.medsci.uu.se/mie/project/closecare).

Applying self-determination theory for improved understanding of physiotherapists' rationale for using research in clinical practice: a qualitative study in Sweden.

PubMed

Dannapfel, Petra; Peolsson, Anneli; Ståhl, Christian; Öberg, Birgitta; Nilsen, Per

2014-01-01

Physiotherapists are generally positive to evidence-based practice (EBP) and the use of research in clinical practice, yet many still base clinical decisions on knowledge obtained during their initial education and/or personal experience. Our aim was to explore motivations behind physiotherapists' use of research in clinical practice. Self-Determination Theory was applied to identify the different types of motivation for use of research. This theory posits that all behaviours lie along a continuum of relative autonomy, reflecting the extent to which a person endorses their actions. Eleven focus group interviews were conducted, involving 45 physiotherapists in various settings in Sweden. Data were analysed using qualitative content analysis and the findings compared with Self-Determination Theory using a deductive approach. Motivations underlying physiotherapists use of research in clinical practice were identified. Most physiotherapists expressed autonomous forms of motivation for research use, but some exhibited more controlled motivation. Several implications about how more evidence-based physiotherapy can be achieved are discussed, including the potential to tailor educational programs on EBP to better account for differences in motivation among participants, using autonomously motivated physiotherapists as change agents and creating favourable conditions to encourage autonomous motivation by way of feelings of competence, autonomy and a sense of relatedness.

Regulatory Considerations for the Clinical and Research Use of Transcranial Direct Current Stimulation (tDCS): review and recommendations from an expert panel

PubMed Central

Fregni, F; Nitsche, MA; Loo, C.K.; Brunoni, AR; Marangolo, P; Leite, J; Carvalho, S; Bolognini, N; Caumo, W; Paik, NJ; Simis, M; Ueda, K; Ekhitari, H; Luu, P; Tucker, DM; Tyler, WJ; Brunelin, J; Datta, A; Juan, CH; Venkatasubramanian, G; Boggio, PS; Bikson, M

2014-01-01

The field of transcranial electrical stimulation (tES) has experienced significant growth in the past 15 years. One of the tES techniques leading this increased interest is transcranial direct current stimulation (tDCS). Significant research efforts have been devoted to determining the clinical potential of tDCS in humans. Despite the promising results obtained with tDCS in basic and clinical neuroscience, further progress has been impeded by a lack of clarity on international regulatory pathways. We therefore convened a group of research and clinician experts on tDCS to review the research and clinical use of tDCS. In this report, we review the regulatory status of tDCS, and we summarize the results according to research, off-label and compassionate use of tDCS in the following countries: Australia, Brazil, France, Germany, India, Iran, Italy, Portugal, South Korea, Taiwan and United States. Research use, off label treatment and compassionate use of tDCS are employed in most of the countries reviewed in this study. It is critical that a global or local effort is organized to pursue definite evidence to either approve and regulate or restrict the use of tDCS in clinical practice on the basis of adequate randomized controlled treatment trials. PMID:25983531

Developing a clinical academic career pathway for nursing.

PubMed

Coombs, Maureen; Latter, Sue; Richardson, Alison

Since the publication of the UK Clinical Research Collaboration's (UKRC, 2007) recommendations on careers in clinical research, interest has grown in the concept of clinical academic nursing careers, with increased debate on how such roles might be developed and sustained (Department of Health, 2012). To embed clinical academic nursing roles in the NHS and universities, a clear understanding and appreciation of the contribution that such posts might make to organisational objectives and outcomes must be developed. This paper outlines an initiative to define the potential practice and research contribution of clinical academic roles through setting out role descriptors. This exercise was based on our experience of a clinical academic career initiative at the University of Southampton run in partnership with NHS organisations. Role descriptors were developed by a group of service providers, academics and two clinical academic award-holders from the local programme. This paper outlines clinical academic roles from novice to professor and describes examples of role descriptors at the different levels of a career pathway. These descriptors are informed by clinical academic posts in place at Southampton as well as others at the planning stage. Understanding the nature of clinical academic posts and the contribution that these roles can make to healthcare will enable them to become embedded into organisational structures and career pathways.

Priorities for clinical research in intracerebral hemorrhage: report from a National Institute of Neurological Disorders and Stroke workshop.

PubMed

2005-03-01

Spontaneous intracerebral hemorrhage (ICH) is one of the most lethal stroke types. In December 2003, a National Institute of Neurological Disorders and Stroke (NINDS) workshop was convened to develop a consensus for ICH research priorities. The focus was clinical research aimed at acute ICH in patients. Workshop participants were divided into 6 groups: (1) current state of ICH research; (2) basic science; and (3) imaging, (4) medical, (5) surgical, and (6) clinical methodology. Each group formulated research priorities before the workshop. At the workshop, these were discussed and refined. Recent progress in management of hemorrhage growth, intraventricular hemorrhage, and limitations in the benefit of open craniotomy were noted. The workshop identified the importance of developing animal models to reflect human ICH, as well as the phenomena of rebleeding. More human ICH pathology is needed. Real-time, high-field magnets and 3-dimensional imaging, as well as high-resolution tissue probes, are ICH imaging priorities. Trials of acute blood pressure-lowering in ICH and coagulopathy reversal are medical priorities. The exact role of edema in human ICH pathology and its treatment requires intensive study. Trials of minimally invasive surgical techniques including mechanical and chemical surgical adjuncts are critically important. The methodologic challenges include establishing research networks and a multi-specialty approach. Waiver of consent issues and standardizing care in trials are important issues. Encouragement of young investigators from varied backgrounds to enter the ICH research field is critical. Increasing ICH research is crucial. A collaborative approach is likely to yield therapies for this devastating form of brain injury.

Exploring Decision-Making of HIV-Infected Hispanics and African Americans Participating in Clinical Trials

PubMed Central

Rivera-Goba, Migdalia V.; Dominguez, Dinora C.; Stoll, Pamela; Grady, Christine; Ramos, Catalina; Mican, JoAnn M.

2011-01-01

Underrepresentation of HIV-infected Hispanics and African Americans in clinical trials seriously limits our understanding of the benefits and risks of treatment in these populations. This qualitative study examined factors that racial/ethnic minority patients consider when making decisions regarding research participation. Thirty-five HIV-infected Hispanic and African American patients enrolled in clinical research protocols at the National Institutes of Health were recruited to participate in focus groups and in-depth interviews. The sample of mostly men (n = 22), had a mean age of 45, nearly equal representation of race/ethnicity, and diagnosed 2 to 22 years ago. Baseline questionnaires included demographics and measures of social support and acculturation. Interviewers had similar racial/ethnic, cultural, and linguistic backgrounds as the participants. Four major themes around participants’ decisions to enroll in clinical trials emerged: Enhancers, Barriers, Beliefs, and Psychosocial Context. Results may help researchers develop strategies to facilitate inclusion of HIV-infected Hispanics and African Americans into clinical trials. PMID:21256054