Clinical Research Knowledge Research Articles

Bayesian methodology for the design and interpretation of clinical trials in critical care medicine: a primer for clinicians.

To review Bayesian methodology and its utility to clinical decision making and research in the critical care field. Clinical, epidemiological, and biostatistical studies on Bayesian methods in PubMed and Embase from their inception to December 2013. Bayesian methods have been extensively used by a wide range of scientific fields, including astronomy, engineering, chemistry, genetics, physics, geology, paleontology, climatology, cryptography, linguistics, ecology, and computational sciences. The application of medical knowledge in clinical research is analogous to the application of medical knowledge in clinical practice. Bedside physicians have to make most diagnostic and treatment decisions on critically ill patients every day without clear-cut evidence-based medicine (more subjective than objective evidence). Similarly, clinical researchers have to make most decisions about trial design with limited available data. Bayesian methodology allows both subjective and objective aspects of knowledge to be formally measured and transparently incorporated into the design, execution, and interpretation of clinical trials. In addition, various degrees of knowledge and several hypotheses can be tested at the same time in a single clinical trial without the risk of multiplicity. Notably, the Bayesian technology is naturally suited for the interpretation of clinical trial findings for the individualized care of critically ill patients and for the optimization of public health policies. We propose that the application of the versatile Bayesian methodology in conjunction with the conventional statistical methods is not only ripe for actual use in critical care clinical research but it is also a necessary step to maximize the performance of clinical trials and its translation to the practice of critical care medicine.

Site Characteristics Influencing the Translation of Clinical Research Into Clinical Practice.

Investigative sites participating in clinical trials play an instrumental role in aiding market adoption. Site experiences in clinical research help physician investigators and research professionals gain familiarity with and exposure to investigational treatments. This knowledge may be passed on to sponsor companies and may ultimately assist in positioning new products and driving commercialization success. This study evaluates site characteristics that influence the acquisition and sharing of knowledge gained through clinical trial experience. The impact of 2 central site characteristics on the process of translating drug experience is assessed: site location (North America/rest of the world) and site type or setting (academic/independent). The results show that investigative sites located outside North America generate and share more knowledge than those within North America. Furthermore, although both academic and independent sites generate the same level of knowledge, academic sites share more of this knowledge with sponsor companies. This study suggests new strategies that sponsors can leverage to drive greater transfer of clinical research knowledge into clinical practice and ultimately improve the commercialization of newly launched therapies.

Clinical research education: perspectives of nurses, employers, and educators.

The aim of this study was to understand the current environment around clinical research relating to nursing education and practice. This descriptive study analyzed data from 33 in-depth interviews with faculty members, nurse executives, staff development directors, and practicing nurses, as well as an online interactive brainstorming session with 28 deans of schools of nursing (or their designee). Patterns and themes that emerged within each group were identified and analyzed in relation to study objectives. Central themes emerged around participants' knowledge and attitudes about clinical research education for baccalaureate nursing students, factors enhancing or inhibiting inclusion of clinical research content in baccalaureate nursing programs, and professional roles nursing students could expect to assume after graduation. Although the participants agreed that mastery of clinical research knowledge and related skills is important, there was no agreement whether nurses should receive this education and training in baccalaureate programs or in staff development.

Nurse awareness of clinical research: a survey in a Japanese University Hospital.

BackgroundClinical research plays an important role in establishing new treatments and improving the quality of medical practice. Since the introduction of the concept of clinical research coordinators (CRC) in Japan, investigators and CRC work as a clinical research team that coordinates with other professionals in clinical trials leading to drug approval (registration trials). Although clinical nurses collaborate with clinical research teams, extended clinical research teams that include clinical nurses may contribute to the ethical and scientific pursuit of clinical research.MethodsAs knowledge of clinical research is essential for establishing an extended clinical research team, we used questionnaires to survey the knowledge of clinical nurses at Tokushima University Hospital. Five-point and two-point scales were used. Questions as for various experiences were also included and the relationship between awareness and experiences were analyzed.ResultsAmong the 597 nurses at Tokushima University Hospital, 453 (75.9%) responded to the questionnaires. In Japan, registration trials are regulated by pharmaceutical affairs laws, whereas other types of investigator-initiated research (clinical research) are conducted based on ethical guidelines outlined by the ministries of Japan. Approximately 90% of respondents were aware of registration trials and clinical research, but less than 40% of the nurses were aware of their difference. In clinical research terminology, most respondents were aware of informed consent and related issues, but ≤50% were aware of other things, such as the Declaration of Helsinki, ethical guidelines, Good Clinical Practice, institutional review boards, and ethics committees. We found no specific tendency in the relationship between awareness and past experiences, such as nursing patients who were participating in registration trials and/or clinical research or taking a part in research involving patients as a nursing student or a nurse.ConclusionsThese findings suggest that clinical nurses have only limited knowledge on clinical research and the importance to have chances to make nurses aware of clinical research-related issues is suggested to establish an extended research team. Because of the study limitations, further study is warranted to determine the role of clinical nurses in establishing a suitable infrastructure for ethical pursuit of clinical research.

Interdisciplinary approaches to the phenomenology of auditory verbal hallucinations.

Despite the recent proliferation of scientific, clinical, and narrative accounts of auditory verbal hallucinations (AVHs), the phenomenology of voice hearing remains opaque and undertheorized. In this article, we outline an interdisciplinary approach to understanding hallucinatory experiences which seeks to demonstrate the value of the humanities and social sciences to advancing knowledge in clinical research and practice. We argue that an interdisciplinary approach to the phenomenology of AVH utilizes rigorous and context-appropriate methodologies to analyze a wider range of first-person accounts of AVH at 3 contextual levels: (1) cultural, social, and historical; (2) experiential; and (3) biographical. We go on to show that there are significant potential benefits for voice hearers, clinicians, and researchers. These include (1) informing the development and refinement of subtypes of hallucinations within and across diagnostic categories; (2) “front-loading” research in cognitive neuroscience; and (3) suggesting new possibilities for therapeutic intervention. In conclusion, we argue that an interdisciplinary approach to the phenomenology of AVH can nourish the ethical core of scientific enquiry by challenging its interpretive paradigms, and offer voice hearers richer, potentially more empowering ways to make sense of their experiences.

Engaging Undergraduate Students in Child Language Research

To better prepare the professionals and scholars of tomorrow in the field of communication sciences and disorders (CSD), a research project in which undergraduate students collected and analyzed language samples of child-parent dyads is presented. Student researchers gained broad and discipline-specific inquiry skills related to the ethical conduct of research, the literature review process, data collection using language assessment techniques, language sample analysis, and research dissemination. Undergraduate students majoring in CSD developed clinical research knowledge, skills, and dispositions necessary for future graduate level study and professional employment. In addition to the benefits of student growth and development, language samples collected through this project are helping to answer research questions regarding communicative turn-taking opportunities within the everyday routines of young children, the effects of turn-taking interactions on language development, and the construct validity of language sampling analysis techniques.

Capacity building - a challenge for nurse managers

Capacity building - a challenge for nurse managers

Trend and Network Analysis of Common Eligibility Features for Cancer Trials in ClinicalTrials.gov.

ClinicalTrials.gov has been archiving clinical trials since 1999, with > 165,000 trials at present. It is a valuable but relatively untapped resource for understanding trial design patterns and acquiring reusable trial design knowledge. We extracted common eligibility features using an unsupervised tag-mining method and mined their temporal usage patterns in clinical trials on various cancers. We then employed trend and network analysis to investigate two questions: (1) what eligibility features are frequently used to select patients for clinical trials within one cancer or across multiple cancers; and (2) what are the trends in eligibility feature adoption or discontinuation across cancer research domains? Our results showed that each cancer domain reuses a small set of eligibility features frequently for selecting cancer trial patients and some features are shared across different cancers, with value range adjustments for numerical measures. We discuss the implications for facilitating community-based clinical research knowledge sharing and reuse.

Research Training in Integrative Medicine: How Can We Make Teaching and Learning in Research Methods More Sustainable and Engaging?

The aim of this project was to identify strategies for increasing learner engagement and knowledge retention in clinical research training of complementary and integrative medicine (CIM) practitioners, and to offer a conceptual framework to address clinical research training for CIM practitioners. In a featured large-group discussion (15min presentation and 30min discussion), two questions (strategies that are recommended to overcome these barriers; relevant aspects for a framework for building sustainable knowledge) were put to the audience. The sample consisted of 43 participants at the International Congress of Educators in Complementary and Alternative Medicine, in Washington, DC, in October 2012. The featured discussion was moderated and detailed notes were taken. Notes were synthesized and discussed by both authors until consensus was reached. Based on the results from the featured discussion session and a focused literature search, a framework for building sustainable knowledge and skills in clinical research for CIM practitioners was developed. Participants' responses to the questions of engagement and sustainability included curricular structures, pedagogical strategies for instruction, the use of digital tools to extend the learning experience, the necessity to ground instruction firmly in the medical literature of the field, and the relevance of mentoring. Key considerations for building sustainable knowledge in clinical research for CIM practitioners are as follows: (1) prioritizing clinical research training, (2) issues of curriculum and pedagogy, (3) technology/digital tools, (4) administrative challenges, (5) supporting the formation of communities of practice, and (6) cultural perspectives of CIM practitioners.

A worldwide investigation of critical care research coordinators’ self‐reported role and professional development priorities: the winner survey

To describe the self-reported role and professional development priorities of research coordinators in different regions of the world. Research coordinators employed in critical care settings provide clinical and technical expertise in the development, conduct and completion of clinical research studies. Knowledge of this specialised role is well established in some parts of the world, yet emerging in others. Descriptive exploratory study involving research coordinators outside of Australia and New Zealand. An anonymous, structured, multiple-choice, web-based questionnaire conducted between April-May 2011. There were 80 respondents from North America (61%), Europe (29%) and Latin America (10%). The majority of respondents performed data collection and obtained informed consent, and half had presented study findings at conferences or wrote scholarly articles, despite a greater willingness to do so. Requisite skills for the research coordinator role included clinical research knowledge, creative problem solving and the ability to identify/resolve ethical questions. 'Best' reported aspects of the role were promotion of evidence-based clinical practice, intellectual stimulation and autonomy. 'Worst' aspects included heavy workload, lack of funding and recognition. Research coordinators working in critical care settings collect data, require clinical research knowledge and problem-solving skills and are interested in, but have less confidence in, dissemination of research findings. They feel isolated with a lack of support and inadequate remuneration for the effort and time required to maintain the high standards of their role. This is outweighed by the satisfaction derived from promoting the research process and autonomy. Further observational studies aimed at clarifying and advancing the role of the research coordinator is warranted. This study offers insight into the global roles and responsibilities as reported by research coordinators employed in critical care settings.

Translating discoveries of research into general practice: Need of the hour

AbstractWe live in an era of information, innovation and change. There are a wide range of differences between what is known and what is practiced. Variation occurs due to gap between the time that basic and clinical research knowledge takes for transforming into reality of practice. As a result, there is delay between adopting new and useful information and discarding ineffective and harmful ones. The way to fill this gap is performing evaluations of findings available and by making them accessible to the clinician. It is of paramount importance that clinical decision regarding patient health care should incorporate the best available scientific evidence. Clinical decision making based on good quality evidence will lead to more effective and efficient treatments. Evidence alone is never sufficient to make a clinical decision. For effective care, the practitioner needs a more efficient and effective way to search for information as wells as skills to rapidly evaluate and sort out what is useful and relevant.

Does Increased Patient Awareness Improve Accrual Into Cancer-Related Clinical Trials?

Oncology literature cites that only 2% to 4% of patients participate in research. Up to 85% of patients are unaware that clinical trials research is being conducted at their treatment facility or that they might be eligible to participate. It was hypothesized that patients' satisfaction with information regarding clinical trials would improve after targeted educational interventions, and accruals to clinical trials would increase in the year following those interventions. All new patients referred to the cancer center over a 4-month period were mailed a baseline survey to assess their knowledge of clinical research. Subsequently, educational interventions were provided, including an orientation session highlighting clinical trials, a pamphlet, and a reference to a clinical trials Web site. A postintervention survey was sent to the responders of the initial survey 3 months after the initial mailing. Patient satisfaction with information significantly increased after the interventions. There was no increase in subsequent enrollment in clinical trials. Patients who indicated an inclination to participate in clinical trials tended to have greater satisfaction with the information they received. A set of educational interventions designed for cancer patients significantly improved their satisfaction with information on clinical research, but did not improve clinical trial enrollment of these participants as of 1 year after the study. The development of educational interventions may be justified, but such interventions may require prolonged implementation to establish benefit. Information relating to research may be most effectively delivered by patients' primary cancer care providers.

Abstract A26: Developing a network of community research councils to promote and facilitate clinical prevention trial participation in medically underserved populations

Abstract If we are to statistically represent the US population (CIA World Factbook), approximately 20% of all clinical trial participants should be composed of racial and ethnic minorities. However, it is a well documented public health concern that minority participation in clinical trials is minimal at best, namely among cancer trials. The American Cancer Society expects 1.6 million persons to be diagnosed with cancer in 2011 (Cancer Facts and Figures 2011, 1) and in order to develop and evaluate sustainable treatments, clinical trials are a necessity. It is estimated that 3–5 percent of eligible cancer patients will participate in clinical trials (Gotay, C.C., 569). Less than one percent will represent a racial or ethnic minority (npr.org). The purpose of this study is to determine whether or not a Community Research Council can increase minority participation in clinical trials. The Center for Equal Health, a partnership between the University of South Florida, H. Lee Moffitt Cancer Center, and the Tampa Bay Community is committed to increasing minority participation in clinical trials for the purpose of enhancing the current treatment options and research surrounding ailments that directly affect minority communities. The Community Research Council (CRC) was established to advocate for and oversee clinical and translational research activities in the Tampa Bay region. Synthesized by examining examples from several Tribal Nations, this governing body serves to: 1) Strengthen the relationship of the research institutions with the community; 2) Provide oversight, protection, and advocacy of community participants involved in clinical and translational research activities performed by academic and clinical institutions; 3) Create and enhance clinical trial opportunities for underrepresented communities; 4) Empower underrepresented communities with decision-making opportunities concerning research activities that involve their members; and 5) Enhance and expand trust between academic and clinical institutions and the communities that they serve. Within 12 months of formation, the council will expand into at least one other geographical area to build upon existing relationships with other research institutions (i.e., Florida A&M University). This will lead to the development of Minority Clinical Research Networks (MCRN) that will serve as the link between the CRC, clinical practitioners, members of the community, research institutions, and pharmaceutical companies. Long term goals of the CRC include lobbying pharmaceutical companies and private investors to provide more clinical research opportunities in the defined region (i.e., the Florida Counties of Hillsborough, Pasco, and Pinellas). Once clinical trials are created or identified in the region, we will develop a plan to monitor minority participation in these trials over time. We expect to see self-reported increases in clinical research knowledge within one year of CRC implementation in the region. We believe that when clinical practitioners, research institutions, members of the community, and pharmaceutical companies are provided with a central organization that provides education, ethical guidelines, and an opportunity for networking, the long term result will be an increase in minority participation in clinical trials. Citation Information: Cancer Epidemiol Biomarkers Prev 2011;20(10 Suppl):A26.

Abstract B15: Measuring medical mistrust at Dia de la Mujer Latina health fiestas

Abstract Mistrust of research and the medical system is a frequent barrier to participation in clinical trials. However, there is a paucity of data on how medical mistrust serves as a barrier to participation in clinical research among Latinas from various Latin American ethnic groups. Culturally, Latina women are the key decision makers when it comes to healthcare. Therefore, this study focused on Latinas who attended three Dia de la Mujer Latina (DML) health fiestas. Methods: Promotoras de Salud (community health workers) were trained to present a bilingual Medical Abuse and Medical Mistrust Awareness Survey (MAMMAS©), culturally translated, to Latinas from 18 years of age and older at 3 DML Health Fiestas events (Puerto Rico, Houston,Texas and Miami, Florida). MAMMAS© is innovative because it breaks down their perception of the medical institutions as well as their knowledge of clinical research, the HPV vaccine and the well-documented medical abuse historical cases. Questions captured demographics, insurance coverage, assimilation, acculturation, knowledge of preventive screenings for breast and cervical cancer, understanding and perception of clinical trials, awareness of historical medical abuse, mistrust of medical providers, their insights about barriers to obtaining these cancer screenings; and if the barrier of mistrust would hinder them from participating in a clinical research or clinical trial. Conclusions: The results of the MAMMAS survey will emphasize the need for more research on this topic. There were a total of 357 participants who completed the survey, however, there were 527 who began the process but did not complete due to their confusion with the response scale. 201 Survey respondents were conscious of the importance of cancer screening, but expressed fear as a major barrier. 294 Survey respondents believed that mistrust plays a key role in their participation into clinical trials. 253 Survey respondents felt that patients may have been deceived or misled by healthcare organizations 204 Survey respondents stated that mistakes are usually covered up by healthcare organizations. 227 Survey respondents believed that healthcare organization have experimented on patients w/o their knowledge. 269 Survey respondents were aware of some form of medical abuse that occurred. Citation Information: Cancer Prev Res 2010;3(1 Suppl):B15.

臨床薬剤師を対象とした臨床研究への関心度とその教育学的解析

We investigated levels of interest in clinical research among pharmacists working in the clinical field,and specific needs for education to nurture clinical researchers.For this purpose,we conducted a questionnaire survey of 240 participants in the“Basic Seminar on Clinical Research for Pharmacists”.The survey items included reason for being interested in clinical research,enthusiasm for participation in clinical research,recognition of importance of knowledge of clinical research,selfevaluation of proficiency in conducting clinical research,and knowledge of clinical research area of interest.Responses were obtained from 204 participants.The most common reason for being interested in clinical research was“to solve questions/problems in daily activities”.Regarding enthusiasm for participation in clinical research,many respondents were“willing to conduct clinical research at multiple institutions in different geographical areas,with professionals from various fields”.Responses concerning recognition of importance of knowledge of clinical research,and self evaluation of proficiency in conducting clinical research indicated that respondents recognized the importance of such knowledge,but did not regarded themselves as being so proficient.These results suggest that clinical pharmacists currently need practical educational programs in clinical research that can be implemented in clinical practice,and that it is important to improve the content of education in clinical research in response to their needs.

Reusing Clinical Protocol Content to Improve R&D Productivity

Protocols are instructional manuals for clinical research, describing study procedures and their rationale and serving as a guide for how study results will be interpreted and used. Every clinical study begins with a protocol, and all startup, conduct, and reporting activities refer back to it. Therefore, the clinical protocol may be viewed as centrally located in a clinical research knowledge network, whose nodes represent study personnel and their means of conveying knowledge, and whose linkages represent knowledge transfer among personnel. Document-centric practices have limited the efficiency of clinical knowledge transfer by discouraging computer-assisted content reuse. In order for computers to facilitate content reuse, some content must be structured and semantically modeled. Because of its dominant network centrality, the structured protocol environment is ideally situated to become the primary conveyance for new knowledge about planned and in-progress studies (ie, the study metadata). Enterprise-...

Five steps from evidence to effect: exercising clinical freedom to implement research findings

Clinicians read medical journals to keep up to date with new evidence.1,2 To do this effectively means getting through many articles every month. Help with assimilating primary research is available from critically appraised syntheses or meta-analyses published in specialty databases,3 the Cochrane Library4 and other secondary journals.5,6 Some research will have implications for their current clinical practice. As clinicians accumulate new information, they must take it forward for implementation into practice. If they do not, the benefits for patients of research evidence will not be realised. There is clear evidence that clinicians lack confidence in implementing research findings.7,8 Simply making research evidence available through publication is not sufficient to improve care. This is what leads to frustration for researchers, research funders, peer-reviewers and journal editors. Transfer of research into clinical practice often takes too long.9,10 On a worldwide scale, effective evidence-based interventions remain underutilised.9 Unless clinicians keep up to date and have skills in appraising and applying valid and potentially valuable published findings, the journey from evidence to effect will not be shortened. Evidence-based medicine (EBM)11 encourages integration of contemporaneous patient-oriented clinical research knowledge into medical decision-making. EBM also integrates concepts of problem based-learning and lifelong learning because evidence changes over time.12,13 Despite the fact that EBM is highly regarded by many healthcare professionals, it is not widely used.14 With local efforts,11,15–17 where clinicians feel empowered to exercise clinical freedom high levels of evidence-based practice are achievable.18 This commentary will provide a brief overview of the journey from evidence to effect and will outline the hurdles that impede and factors that aid in the implementation of evidence. Using the rational approaches that have been shown to work in diffusion of innovations, clinicians will be able to develop a practical strategy for putting evidence into practice realising the benefits of new research for their patients.

Imaging Update: New Windows, New Views

The recent progress in our understanding of the molecular-genetic mechanisms active in many diseases and the application of new biologically based approaches in therapy are exciting new developments that have emerged following mapping of the human genome. Novel “molecular therapies” have been

Evaluation of clinical research knowledge and interest among pharmacy residents: Survey design and validation

The development and validation of a survey to describe the research knowledge, attitudes, and skills of pharmacy practice residents are described. A survey was drafted to determine if pharmacy practice residency experience and the American Society of Health-System Pharmacists (ASHP)-required project improve the residents' objectively and subjectively assessed research knowledge, to determine if the residency experience and the ASHP-required project affect the residents' attitudes regarding research as a component of their future professional practice, and to subjectively assess the effect of the residency experience and the ASHP-required project on other essential skills, such as problem solving, critical thinking, and time management. An initial questionnaire was developed and underwent content validation testing by clinical pharmacists and faculty, residents, and research fellows. Following content validation, the questionnaire underwent construct validity testing (for discriminative validity and responsiveness) in students, residents, and clinical pharmacists and faculty. Reliability was tested in a subgroup of subjects who completed the questionnaire twice within two to four weeks. From the content validation phase, average scores for individual questions ranged from 1.00 to 2.00. Discriminative validity testing of the revised questionnaire demonstrated the instrument's ability to discriminate between groups expected to differ. Effect-size and mean-knowledge score differences indicated high levels of responsiveness, signifying the instrument's ability to detect change over time or after an intervention. A survey questionnaire developed to measure research knowledge and interest among pharmacy practice residents demonstrated its validity and reliability with significant sensitivity and responsiveness.

Involving cancer patients in clinical practice guidelines (CPGs) development in a French guidelines program: What are the key issues?

16029 Background: The translation of clinical research knowledge into CPGs involves interpretation of the evidence and value judgments. Patients’ preferences are essential in defining optimal cancer treatment because of the uncertain outcomes and important side effects. Their perspective should therefore be integrated into the development of CPGs (one item of the AGREE instrument). The Standards & Options: Recommandations program (SOR), of the French Federation of Comprehensive Cancer Centres has developed evidence-based cancer CPGs since 1993. To improve the quality and relevance of their CPGs the SOR program decided to develop a comprehensive method to involve cancer patients in the process. Methods: We developed an approach for the French context of cancer CPGs based on 3 inputs 1) Review of the literature from relevant databases and websites. 2) Review of the experiences of the National Institute for Health and Clinical Excellence and the Scottish Intercollegiate Network. 3) Multidisciplinary scientific committee (clinicians, patients, psychologists, sociologists, methodologists and healthy volunteers). Results: The data and the work of the experts allowed to identify the key issues for building a French approach 1) “Patient” includes patients under treatment, former patients, carers, members of a patients’ association, healthy volunteers. Patients are recruited through patients’ associations, clinicians, educational groups, newspaper announcements. 2) The patient plays a significant role in defining the clinical question, particularly the outcomes to be considered as well in the drafting of the CPG. They ensure that a patient perspective complements (and sometimes challenges) the views of professional members of the working group. 3) The major method for involving patients is to have them participate in the working group. 4) To train and support the patients is essential. 5) Informing the working group on the importance of taking into account the patient in the drafting of the CPG is a major issue. 6) A preliminary study demonstrates the feasibility and acceptability of patients’ involvement. Conclusions: This process is valuable and will be implemented in the SOR program. No significant financial relationships to disclose.