Academic response to improving value and reducing waste: A comprehensive framework for INcreasing QUality In patient-oriented academic clinical REsearch (INQUIRE)

The overall quality of the clinical research is low in India and there are number of social determinants of health, cultural, institutional, fiscal, financial plus technological factors that affects the performance and management of clinical researchers. The study focuses to understand the important effects of the multidisciplinary clinical research teams and human resource management on the outcomes of the clinical research. The study uses systematic review and thematic analysis as the methodology in order to understand the research problem in detail and provide solutions to the clinical research problems in the country. A total of scholarly 21 articles has been systematically reviewed and four major themes has been found out. The study finds out multiple complex factors that ranges from technical, professional, personal, social, cultural dimensions to institutional and organizational types that needs to be addressed, in order to improve the quality of clinical and medical research in the country. The translational and the implementation sciences has been found to play a critical role in clinical research and the academic-industry collaborations is necessary too. The human resource management plays a cardinal role in the whole undertaken of the clinical research process that has been explained in the research study. The implications of the human resource management and the clinical research management has been mentioned as well, that is to be considered very closely.

To meet the urgent needs for expertise in clinical research in China, Peking University established the graduate training program of sciences in clinical research in November 2013 as the first in the country. To ensure the high quality of this discipline, a research group was established to explore and innovate the training plan, including training objectives, curriculum system, teaching methods, and practice of sciences in clinical research. Meanwhile, a solid support system was established on the discipline management, faculty team building, student examination and evaluation, and quality control assurance. A scientific and practical talents training model was built up and achievements have been seen now with these efforts. Key words: Sciences in clinical research; Talents training model; Exploring and innovating

To standardize optic nerve sheath diameter (ONSD) point-of-care ultrasonography (POCUS) and improve its research and clinical utility by developing the ONSD POCUS Quality Criteria Checklist (ONSD POCUS QCC). Three rounds of modified Delphi consensus process and three rounds of asynchronous discussions. Online surveys and anonymous asynchronous discussion. Expert panelists were identified according to their expertise in ONSD research, publication records, education, and clinical use. A total of 52 panelists participated in the Delphi process. None. Three Delphi rounds and three asynchronous discussion rounds generated consensus on quality criteria (QC). This started with 29 QC in addition to other QC proposed by expert panelists. The QC items were categorized into probe selection, safety, body position, imaging, measurement, and research considerations. At the conclusion of the study, 28 QC reached consensus to include in the final ONSD POCUS QCC. These QC were then reorganized, edited, and consolidated into 23 QC that were reviewed and approved by the panelists. ONSD POCUS QCC standardizes ONSD ultrasound imaging and measurement based on international consensus. This can establish ONSD ultrasound in clinical research and improve its utility in clinical practice.

The workshop that this paper reports, held in Iran in May of 2011, at the 1st Inter-national and 4th National Congress on Health Education and Promotion, had three main objec-tives: 1) to introduce participants to the knowledge translation (KT) concept, along with its mod-els and methods; 2) to enhance participants' knowledge of how KT could apply to public health education and promotion ; and 3) to learn from different participating stakeholder groups about the factors that facilitate or impede effective KT in public health education and promotion in Iran. The workshop consisted of three components: introducing the KT concept, assessing the KT capacity of participants, and facilitating a discussion of the important contextual factors that promote and impede effective KT. Of the 26 individuals from across the country participat-ing in the workshop, 17 took part in a KT capacity assessment activity. They classified them-selves into one of the following three stakeholder groups: administrators and policymakers (n=6), practitioners (n=2), and researchers (n=9). There were different capacities for KT across the three stakeholder groups. The re-ported challenges for effective KT include "lack of resources and funding"; "lack of time"; "poor quality of relationships and lack of trust between health policymakers, administrators, re-searchers, and clinicians"; "inadequate skills possessed by healthcare professionals and adminis-trators for assessment and adaptation of research findings"; and "poor involvement of commu-nity partners in the research process." There is a great need to develop effective strategies to overcome the reported barri-ers for effective KT.

Patient preferences are playing an increasingly pivotal role in defining care pathways, assessing care quality, and advancing healthcare technologies, but their current use remains unclear. We conducted an online survey collecting data from 46 experts in clinical research, pharmaceutical industry, regulatory affairs, and health technology assessment. About 30% of our respondents are using PPI routinely, and 90% are willing to prioritize their integration in the future, despite various challenges, such as limited patient engagement, difficulty in obtaining reliable data, and reluctance to deviating from traditional practices. We show here a growing recognition of the potential benefits of integrating PPI, and that concerted efforts and investments are necessary to support a wider adoption.

Thanks to its expertise in clinical research, epidemiology, infectious diseases, microbiology, parasitology, public health, translational research and tropical medicine, coupled with deeply rooted partnerships with institutions in low- and middle-income countries (LMICs), the Swiss Tropical and Public Health Institute (Swiss TPH) has been a key contributor in many drug research and development consortia involving academia, pharma and product development partnerships. Our know-how of the maintenance of parasites and their life-cycles in the laboratory, plus our strong ties to research centres and disease control programme managers in LMICs with access to field sites and laboratories, have enabled systems for drug efficacy testing in vitro and in vivo, clinical research, and modelling to support the experimental approaches. Thus, Swiss TPH has made fundamental contributions towards the development of new drugs - and the better use of old drugs - for neglected tropical diseases and infectious diseases of poverty, such as Buruli ulcer, Chagas disease, food-borne trematodiasis (e.g. clonorchiasis, fascioliasis and opisthorchiasis), human African trypanosomiasis, leishmaniasis, malaria, schistosomiasis, soil-transmitted helminthiasis and tuberculosis. In this article, we show case the success stories of molecules to which Swiss TPH has made a substantial contribution regarding their use as anti-infective compounds with the ultimate aim to improve people's health and well-being.

Methotrexate (MTX) is a readily accessible drug, first used in 1948 and employed for a wide variety of indications since then. However, despite widespread off-label use, FDA labeling does not include approved indications for the use of MTX for many inflammatory skin diseases in pediatric patients, including morphea, psoriasis, atopic dermatitis, and alopecia areata, among others. Without published treatment guidelines, some clinicians may be hesitant to use MTX off-label, or uncomfortable prescribing MTX in this population. To address this unmet need, an expert consensus committee was convened to develop evidence- and consensus-based guidelines for use of MTX to treat pediatric inflammatory skin disease. Clinicians with experience and expertise in clinical research, drug development, and treating inflammatory skin disease in pediatric patients with MTX were recruited. Five committees were created based on major topic areas: (1) indications and contraindications, (2) dosing, (3) interactions with immunizations and medications, (4) adverse effects (potential for and management of), and (5) monitoring needs. Pertinent questions were generated and addressed by the relevant committee. The entire group participated in a modified Delphi process to establish agreement on recommendations for each question. The committee developed 46 evidence- and consensus-based recommendations, each with >70% agreement among members, across all five topics. These are presented in tables and text, along with a discussion of supporting literature, and level of evidence. These evidence- and consensus-based recommendations will support safe and effective use of MTX for the underserved population of pediatric patients who may benefit from this valuable, time-honored medication.

Assessments by Patients With Schizophrenia and Psychiatrists of Relative Risk of Research Procedures

Consensus Recommendations on the Treatment of Opioid Use Disorder in the Emergency Department

Quality in clinical research may be defined as compliance with requirements together with credibility and reliability of the data obtained. Sponsors usually apply Quality Management Systems (QMS) to ensure, control, maintain, and improve quality. These systems encompass several preventive measures, tools, and controls. Standard QMS applied by clinical research sponsors may be based on ISO 9000.

BackgroundPriority‐setting is a way to focus research and knowledge translation (KT) efforts for community‐based research partnerships (CBRP).ObjectiveTo identify the developmental coordination disorder (DCD) research and KT priorities of stakeholders in Quebec, Canada, and their perceptions regarding the implementation of a CBRP.DesignAn advisory committee oversaw the research process including an online survey and four community forums.Setting and participantsThe survey was posted online and four community forums were organized. Participants included parents of children with DCD, adults with DCD, health professionals and school staff.Main variablesStakeholder generated research and KT priorities, and optimal CBPR conditions.Outcome measuresParticipants selected their top five priorities based on a predefined list of 16 research and 12 KT priorities determined in collaboration with the advisory committee. They also rated the importance of various CBRP conditions. Preliminary survey results were discussed during the forums.ResultsSurvey participants (n = 395) identified interwoven research and KT priorities where access to services was considered to be essential: supporting children at school; improving DCD identification and diagnosis; preventing secondary consequences; improving the organization of services and implementing effective services. Forum participants (n = 52) confirmed the relevance of these priorities and supported the establishment of a CBRP inclusive of all stakeholders to improve DCD services, research and KT.Discussion and conclusionsA general consensus emerged among all groups, but adults with DCD were more concerned with employment than were the other stakeholder groups. These findings are presently being used to shape an ongoing, online CBRP.

New European rules on orphan drugs

Guideline on the design and conduct of cystic fibrosis clinical trials: The European Cystic Fibrosis Society–Clinical Trials Network (ECFS-CTN)

The role of nurse with Master Degree represents an challenge career opportunity for professional nurses. Currently, there are only 2 Professional Master in Nursing in Brazil, one is at São Paulo Federal University (SP) and the other, recently approved by CAPES, is at Fluminense Federal University (RJ). At the Fluminense Federal University, the Professional Master in Nursing Program was designed for experienced nurses who is seeking preparation for advanced practice as a clinical specialist, educator, researcher, or administrator. It includes course work and clinical experience in advanced health assessment, physiology, pathophysiology and pharmacology, as well as research, nursing theories, health promotion and disease prevention, healthcare policy, health and culture, diagnostic reasoning, and clinical decision making. In addition to course work, nurses are required to publish an original article and to produce a dissertation. The Professional Master in Nursing encompass a 2 year program of study with specialized clinical experiences. Upon graduation, the nurse will have a base of knowledge in a specific area of nursing care; and can participate knowledgeably in research activity and application. Advanced clinical education and experience based on scientifc evidences have been identified as requirements for practice as a nurse with Professional Master Degree. The nursing practice has recently expanded as a result of changes occurring in health care settings, including increased acuity of hospitalized patients, demands of management hability to reduce length of stay and to coordinate patient/family care. The scope of practice for nurses with a Professional Master Degree is broad-based and involves, mainly, providing advanced nursing care to patients and their families according to the practice setting and patient population. For example, it may comprehend also therapeutic procedure work, aspects of case management, discharge planning, monitoring quality standards, clinical research, undergraduate preceptorship, and inservice education of nursing staff for the instituition. The Professional Master in Nursing at the Fluminense Federal University will offer a unique advanced practice opportunity for nurses to develop their nursing careers and for healthcare institutions and nursing faculties to improve the quality of their services.The Professional Master in Nursing at the Fluminense Federal University will be offered in March 2004. Do not miss the deadlines!

Introduction: Establishing a multicenter pituitary surgical research and outcomes consortium is central to improving patient care by facilitating quality improvement, research, and dissemination of best practices. In addition, it holds the potential for expediting multicenter studies and fostering collaboration between programs for the benefit of patients. We describe the establishment of a multicenter research initiative, the Registry of Adenomas of the Pituitary and Related Disorders (RAPID). The goals of the initiative are to serve the clinician–scientist through accelerating pituitary tumor research by (1) developing a platform for multicenter quality improvement efforts and clinical research, (2) promoting collegiality and scholarship, and (3) applying innovative solutions to the challenges of outcomes research.