Mapping actions to improve access to medicines for mental disorders in low and middle income countries.

PubMed

Barbui, C; Dua, T; Kolappa, K; Saraceno, B; Saxena, S

2017-10-01

In recent years a number of intergovernmental initiatives have been activated in order to enhance the capacity of countries to improve access to essential medicines, particularly for mental disorders. In May 2013 the 66th World Health Assembly adopted the World Health Organization (WHO) Comprehensive Mental Health Action Plan 2013-2020, which builds upon the work of WHO's Mental Health Gap Action Programme. Within this programme, evidence-based guidelines for mental disorders were developed, including recommendations on appropriate use of medicines. Subsequently, the 67th World Health Assembly adopted a resolution on access to essential medicines, which urged Member States to improve national policies for the selection of essential medicines and to promote their availability, affordability and appropriate use. Following the precedent set by these important initiatives, this article presents eleven actions for improving access and appropriate use of psychotropic medicines. A 4 × 4 framework mapping actions as a function of the four components of access - selection, availability, affordability and appropriate use - and across four different health care levels, three of which belong to the supply side and one to the demand side, was developed. The actions are: developing a medicine selection process; promoting information and education activities for staff and end-users; developing a medicine regulation process; implementing a reliable supply system; implementing a reliable quality-control system; developing a community-based system of mental health care and promoting help-seeking behaviours; developing international agreements on medicine affordability; developing pricing policies and a sustainable financing system; developing or adopting evidence-based guidelines; monitoring the use of psychotropic medicines; promoting training initiatives for staff and end-users on critical appraisal of scientific evidence and appropriate use of psychotropic medicines. Activating these actions offers an unique opportunity to address the broader issue of increasing access to treatments and care for mental disorders, as current lack of attention to mental disorders is a central barrier across all domains of the 4 × 4 access framework.

[Quality process control system of Chinese medicine preparation based on "holistic view"].

PubMed

Wang, Ya-Qi; Jiao, Jiao-Jiao; Wu, Zhen-Feng; Zheng, Qin; Yang, Ming

2018-01-01

"High quality, safety and effectiveness" are the primary principles for the pharmaceutical research and development process in China. The quality of products relies not only on the inspection method, but also on the design and development, process control and standardized management. The quality depends on the process control level. In this paper, the history and current development of quality control of traditional Chinese medicine (TCM) preparations are reviewed systematically. Based on the development model of international drug quality control and the misunderstanding of quality control of TCM preparations, the reasons for impacting the homogeneity of TCM preparations are analyzed and summarized. According to TCM characteristics, efforts were made to control the diversity of TCM, make "unstable" TCM into "stable" Chinese patent medicines, put forward the concepts of "holistic view" and "QbD (quality by design)", so as to create the "holistic, modular, data, standardized" model as the core of TCM preparation quality process control model. Scientific studies shall conform to the actual production of TCM preparations, and be conducive to supporting advanced equipment and technology upgrade, thoroughly applying the scientific research achievements in Chinese patent medicines, and promoting the cluster application and transformation application of TCM pharmaceutical technology, so as to improve the quality and effectiveness of the TCM industry and realize the green development. Copyright© by the Chinese Pharmaceutical Association.

[Patented technology status quo and development trend for Chinese herbal medicines].

PubMed

Li, Chang; Huang, Luqi

2009-06-01

Patent technology is regarded as technological trends under the market economy condition. The case showed the information form patent literature can be widely used in technology or economy. In this study, we analyzed the patent technology status quo and development trend for Chinese herbal medicines based on China patent database. The patent technology status quo is divided from the technology of biotechnology, quality control, cultivation and herb processing on Chinese herbal medicines. Furthermore, some recommendations of technology development and advices on patent protection for Chinese herbal medicines were suggested.

Geriatric Core Competencies for Family Medicine Curriculum and Enhanced Skills: Care of Elderly

PubMed Central

Charles, Lesley; Triscott, Jean A.C.; Dobbs, Bonnie M.; McKay, Rhianne

2014-01-01

Background There is a growing mandate for Family Medicine residency programs to directly assess residents’ clinical competence in Care of the Elderly (COE). The objectives of this paper are to describe the development and implementation of incremental core competencies for Postgraduate Year (PGY)-I Integrated Geriatrics Family Medicine, PGY-II Geriatrics Rotation Family Medicine, and PGY-III Enhanced Skills COE for COE Diploma residents at a Canadian University. Methods Iterative expert panel process for the development of the core competencies, with a pre-defined process for implementation of the core competencies. Results Eighty-five core competencies were selected overall by the Working Group, with 57 core competencies selected for the PGY-I/II Family Medicine residents and an additional 28 selected for the PGY-III COE residents. The core competencies follow the CanMEDS Family Medicine roles. Both sets of core competencies are based on consensus. Conclusions Due to demographic changes, it is essential that Family Physicians have the required skills and knowledge to care for the frail elderly. The core competencies described were developed for PGY-I/II Family Medicine residents and PGY-III Enhanced Skills COE, with a focus on the development of geriatric expertise for those patients that would most benefit. PMID:24883163

Challenges in the development and reimbursement of personalized medicine-payer and manufacturer perspectives and implications for health economics and outcomes research: a report of the ISPOR personalized medicine special interest group.

PubMed

Faulkner, Eric; Annemans, Lieven; Garrison, Lou; Helfand, Mark; Holtorf, Anke-Peggy; Hornberger, John; Hughes, Dyfrig; Li, Tracy; Malone, Daniel; Payne, Katherine; Siebert, Uwe; Towse, Adrian; Veenstra, David; Watkins, John

2012-12-01

Personalized medicine technologies can improve individual health by delivering the right dose of the right drug to the right patient at the right time but create challenges in deciding which technologies offer sufficient value to justify widespread diffusion. Personalized medicine technologies, however, do not neatly fit into existing health technology assessment and reimbursement processes. In this article, the Personalized Medicine Special Interest Group of the International Society for Pharmacoeconomics and Outcomes Research evaluated key development and reimbursement considerations from the payer and manufacturer perspectives. Five key areas in which health economics and outcomes research best practices could be developed to improve value assessment, reimbursement, and patient access decisions for personalized medicine have been identified. These areas are as follows: 1 research prioritization and early value assessment, 2 best practices for clinical evidence development, 3 best practices for health economic assessment, 4 addressing health technology assessment challenges, and 5 new incentive and reimbursement approaches for personalized medicine. Key gaps in health economics and outcomes research best practices, decision standards, and value assessment processes are also discussed, along with next steps for evolving health economics and outcomes research practices in personalized medicine. Copyright © 2012 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

Update of the ERS international Adult Respiratory Medicine syllabus for postgraduate training.

PubMed

Tabin, Nathalie; Mitchell, Sharon; O'Connell, Elaine; Stolz, Daiana; Rohde, Gernot

2018-03-01

First published in 2006, the first European core syllabus in Adult Respiratory Medicine was developed with the intention of harmonising education and training throughout Europe. Internationally recognised by the European Union of Medical Specialists and identified as the first document of its kind in respiratory medicine, it has provided a comprehensive guide for both local and national institutions in the development of adult respiratory training programmes. Like all fields in education, respiratory medicine is an ever-changing area and as such, respective syllabi, curricula and training programmes must adapt and diversify in line with the evolution of core medical concepts. Given the proven importance of the Adult Respiratory Medicine syllabus from both a national and international standpoint, it is of equal importance that said syllabus remains abreast of emerging trends so as to sustain the synchronisation of respiratory medicine in Europe. In order to develop an updated programme, a comprehensive review process of the current syllabus is a necessary endeavour and a step that the European Respiratory Society (ERS) has undertaken through the process of a needs assessment.

[On the formulation of TCM foreign exchange policy after the reform and opening-up].

PubMed

Wang, Jingfang; Zhu, Jianping

2015-03-01

The foreign exchange activities of traditional Chinese medicine are conducted under the guidance of the policy of the CPC and Chinese government. After the carrying out of the reform and opening-up policy, foreign exchange policy of TCM has experienced the process of growing up from nothing, from less to more, and from coarse to fine, which is closely related to our country's foreign policy, the cause of Chinese medicine development, and urgent need of international communication. In the three decades after the reform and opening-up policy, the formulation of foreign exchange policy of TCM can be divided into three stages: viz., inclusion in the framework of national foreign policy (1978-1985), embodiment in the policy of developing TCM cause (1986-1996), and appearance in the special policy of foreign exchange of Chinese medicine (since 1997). From the development process of these policies, the development of each policy gradually complies with the process of the development of the times, with its contents basically in line with the requirements of the times. The implementation of some policies promotes the foreign exchanges and cooperation of Chinese medicine.

PCMO L01-Setting Specifications for Biological Investigational Medicinal Products.

PubMed

Krause, Stephan O

2015-01-01

This paper provides overall guidance and best practices for the setting of specifications for clinical biological drug substances and drug products within the framework of ICH guidelines on pharmaceutical development [Q8(R2) and Q11], quality risk management (Q9), and quality systems (Q10). A review is provided of the current regulatory expectations for the specification setting process as part of a control strategy during product development, pointing to existing challenges for the investigational new drug/investigational medicinal product dossier (IND/IMPD) sponsor. A case study illustrates how the investigational medicinal product specification revision process can be managed within a flexible quality system, and how specifications can be set and justified for early and late development stages. This paper provides an overview for the setting of product specifications for investigational medicinal products used in clinical trials. A case study illustrates how product specifications of investigational medicinal products can be justified and managed within a modern product quality system. © PDA, Inc. 2015.

[Development of guidance for the approval process of brand-new medical products and regenerative medicine products].

PubMed

Niimi, Shingo

2015-01-01

Ministry of Health, Labour and Weltare has been conducting development of guidance for the approval process of brand-new medical products/development of guidance for medical devices in collaboration with Ministry of Economy, Trade and Industry as part of measures to promote practical use of brand-new medical products since 2005. The objective of this project is to expedite the processes from developmental process of medical devices to approval review and to introduce the medical devices to medical front quickly.. Ministry of Health, Labour and Welfare side has been making guidance for the guide in approval process of brand-new medical products and regeneration medicine products to aim at acceleration and facilitation of development and approval process of innovative medical products. Twenty-two of the guidance have been issued as director of the evaluation and licensing division. The evaluation index about safety and efficacy required for medical devices and regenerative medicine products in progress were put together in these guidance and useful for medical devices developer to understand the point at the approved review. Therefore, I think that the evaluation index could also contribute to the efficient product development. The guidance about implantable artificial heart is issued as the representative example which was useful in the approved review.

[Survey scheme of the main Chinese medicines resources].

PubMed

Chen, Shi-lin; Zhang, Ben-gang; Yang, Zhi; Su, Gang-qiang; Zhao, Run-huai; Huang, Lin-fang; Ma, Xiao-jun; Zhang, Jin-sheng; Xiao, Pei-gen

2005-08-01

The survey of Chinese medicines resources concerns the development of the traditional Chinese medicine industry. It also directly influences the modernization process of traditional Chinese medicines. Owing to lacking of the scientific data on the Chinese medicines resources, it is a extremely urgent work to carry out survey of main Chinese medicine resources in nationwide. This paper explains the meaning and necessity. And it also investigated the survey object, contents, new technologies and methods.

A modified Delphi study of structures and processes related to medicines management for elderly hospitalised patients in the United Arab Emirates.

PubMed

Al Shemeili, Saeed; Klein, Susan; Strath, Alison; Fares, Saleh; Stewart, Derek

2016-10-01

The structures and processes around the management of medicines for elderly, hospitalized patients are ill defined. This study aimed to determine consensus related to strategic and operational approaches in the United Arab Emirates. A modified Delphi technique, consensus study with first round statements developed from systematic reviews related to medicines management. Normalization process theory and the theoretical domains framework were applied in the construction of statements, organized into key elements of medicines management: guidelines for medicines management, medicines reconciliation, medicines selection, prescribing and review, medicines adherence, medicines counselling, health professional training and evaluation research. Seventy per cent (summative agree and strongly agree) was set as the target for consensus. Thirty panellists were recruited, representing senior physicians working within geriatrics, hospital pharmacy and nursing directors, chief health professionals (including social workers) and policy makers within the Health Authority of Abu Dhabi and academics. A high level of consensus was obtained for most statements relating to the structures and processes of medicines management. While consensus was not achieved for targeting only those patients with medicines related issues, it was achieved for focusing on all elderly admissions. Similarly, consensus was not achieved for which professions were most suited to roles but was achieved for trained and competent staff. High levels of consensus were obtained for structures and processes of medicines management relating to elderly hospitalized patients. Trained and competent health professionals were preferred to specific professions for any tasks and that all elderly patients and not targeted patients should be the focus for medicines management. © 2016 John Wiley & Sons, Ltd.

Drug quality in South Africa: perceptions of key players involved in medicines distribution.

PubMed

Patel, Aarti; Norris, Pauline; Gauld, Robin; Rades, Thomas

2009-01-01

Substandard medicines contribute to poor public health and affect development, especially in the developing world. However knowledge of how manufacturers, distributors and providers understand the concept of drug quality and what strategies they adopt to ensure drug quality is limited, particularly in the developing world. The purpose of this paper is to explore pharmaceutical manufacturers', distributors' and providers' perceptions of drug quality in South Africa and how they ensure the quality of drugs during the distribution process. The approach taken was qualitative data collection through key informant interviews using a semi-structured interview guide. Transcripts were analysed thematically in Johannesburg, Pretoria and Durban, South Africa. Participants were recruited purposefully from a South African pharmaceutical manufacturer, SA subsidiaries of international manufacturers, national distribution companies, national wholesaler, public and private sector pharmacists, and a dispensing doctor. In total, ten interviews were conducted. Participants described drug quality in terms of the product and the processes involved in manufacturing and handling the product. Participants identified purchasing registered medicines from licensed suppliers, use of standard operating procedures, and audits between manufacturer and distributor and/or provider as key strategies employed to protect medicine quality. Effective communication amongst all stakeholders, especially in terms of providing feedback regarding complaints about medicine quality, appears as a potential area of concern, which would benefit from further research. The paper hightlights that ensuring medicine quality should be a shared responsibility amongst all involved in the distribution process to prevent medicines moving from one distribution system (public) into another (private).

The use of economic evaluation for guiding the pharmaceutical reimbursement list in Thailand.

PubMed

Teerawattananon, Yot; Tritasavit, Nattha; Suchonwanich, Netnapis; Kingkaew, Pritaporn

2014-01-01

Medicines expenditure consumes a significant proportion of public health expenditure in Thailand, where Universal Health Coverage has been in place since 2002. The National List of Essential Medicines has been successfully used as a pharmaceutical benefits package for all public health plans. All patients are eligible for all medicines included in the list free of charge by law. Health economic evaluation has been employed as a tool for the development of this list, including price negotiation of medicines before inclusion, especially of high-cost medicines or medicines with high budget implications. This paper illustrates the current process, mechanisms, and impact and informs of seven success factors that have contributed to the successful use of health economic evaluation in Thailand. These include strong political commitment, development of individual and institutional capacity, participation of all relevant stakeholders, establishment of standard methodological and process guidelines, consideration of several elements in the decision-making process, using evidence as a starting point rather than a deciding factor, and strong enforcement. The lessons learned from this study are likely to be applicable to other settings committed to evidence-based decision making. Copyright © 2014. Published by Elsevier GmbH.

[Current situations and problem analysis of influencing factors of traditional Chinese medicine tablets on forming quality].

PubMed

Li, Yan-Nian; Wu, Zhen-Feng; Wan, Na; Li, Yuan-Hui; Li, Hui-Ting; Yang, Ming

2018-04-01

The compressibility of tablets is the essential operating unit during the preparation of traditional Chinese medicine tablets, as well as a complicated process. Therefore, it is of great significance to comprehensively study the influencing factors on the formation process. This paper aimed to review the evaluation methods for the tablet forming quality and highlight the effects of material powder properties, excipients and preparation technology on the quality of traditional Chinese medicine tablets on the basis of relevant literatures. Furthermore, the common problems in tablet forming process are also analyzed to provide useful references for the development of tablet forming quality of traditional Chinese medicines. Copyright© by the Chinese Pharmaceutical Association.

An Evaluation on Medical Education, Research and Development of AYUSH Systems of Medicine through Five Year Plans of India.

PubMed

Samal, Janmejaya; Dehury, Ranjit Kumar

2016-05-01

Indian system of medicine has its origin in India. The system is currently renamed as AYUSH, an acronym for Ayurveda, Yoga & Naturopathy, Unani, Sidha and Homeopathy. These are the six Indian systems of medicine prevalent and practiced in India and in few neighboring Asian countries. The primary objective of this review was to gain insight in to the prior and existing initiatives which would enable reflection and assist in the identification of future change. A review was carried out based on the five year plan documents, obtained from the planning commission web portal of Govt. of India, on medical education, research and development of AYUSH systems of medicine. Post independence, the process of five year planning took its birth with the initiation of long term planning in India. The planning process embraced all the social and technology sectors in it. Since the beginning of five year planning, health and family welfare planning became imperative as a social sector planning. Planning regarding Indian Systems of Medicine became a part of health and family welfare planning since then. During the entire planning process a progressive path of development could be observed as per this evaluation. A relatively sluggish process of development was observed up to seventh plan however post eighth plan the growth took its pace. Eighth plan onwards several innovative development processes could be noticed. Despite the relative developments and growth of Indian systems of medicine these systems have to face lot of criticism and appraisal owing to their various characteristic features. In the beginning the system thrived with great degree of uncertainty, as described in 1(st) five year plan, however progressed ahead with a vision to be a globally accepted system, as envisaged in 11(th) five year plan. A very strong optimistic approach in spreading India's own medical heritage is the need of the hour. The efforts are neither completely insufficient nor sufficient enough; hence a continuous endeavor for the revival and dissemination of India's own medical inheritance for the welfare of the society at large is highly desirable.

An Evaluation on Medical Education, Research and Development of AYUSH Systems of Medicine through Five Year Plans of India

PubMed Central

Dehury, Ranjit Kumar

2016-01-01

Introduction Indian system of medicine has its origin in India. The system is currently renamed as AYUSH, an acronym for Ayurveda, Yoga & Naturopathy, Unani, Sidha and Homeopathy. These are the six Indian systems of medicine prevalent and practiced in India and in few neighboring Asian countries. Objective The primary objective of this review was to gain insight in to the prior and existing initiatives which would enable reflection and assist in the identification of future change. Materials and Methods A review was carried out based on the five year plan documents, obtained from the planning commission web portal of Govt. of India, on medical education, research and development of AYUSH systems of medicine. Results Post independence, the process of five year planning took its birth with the initiation of long term planning in India. The planning process embraced all the social and technology sectors in it. Since the beginning of five year planning, health and family welfare planning became imperative as a social sector planning. Planning regarding Indian Systems of Medicine became a part of health and family welfare planning since then. During the entire planning process a progressive path of development could be observed as per this evaluation. A relatively sluggish process of development was observed up to seventh plan however post eighth plan the growth took its pace. Eighth plan onwards several innovative development processes could be noticed. Despite the relative developments and growth of Indian systems of medicine these systems have to face lot of criticism and appraisal owing to their various characteristic features. In the beginning the system thrived with great degree of uncertainty, as described in 1st five year plan, however progressed ahead with a vision to be a globally accepted system, as envisaged in 11th five year plan. Conclusion A very strong optimistic approach in spreading India’s own medical heritage is the need of the hour. The efforts are neither completely insufficient nor sufficient enough; hence a continuous endeavor for the revival and dissemination of India’s own medical inheritance for the welfare of the society at large is highly desirable. PMID:27437245

User Testing of Consumer Medicine Information in Australia

ERIC Educational Resources Information Center

Jay, Eleanor; Aslani, Parisa; Raynor, D. K.

2011-01-01

Background: Consumer Medicine Information (CMI) forms an important basis for the dissemination of medicines information worldwide. Methods: This article presents an overview of the design and development of Australian CMI, and discusses "user-testing" as an iterative, formative process for CMI design. Findings: In Australia, legislation…

An Unfulfilled Promise: Changes Needed to the Drug Approval Process to Make Personalized Medicine a Reality.

PubMed

Riley, Margaret Foster

2015-01-01

The widespread availability of drugs for personalized medicine has been an aspiration since before the human genome was sequenced. Recently, there is renewed interest; personalized medicine is much in the news. Legislation has been considered with the goal of smoothing, shortening and incentivizing the approval process for therapeutic products. President Obama mentioned the need for new initiatives to achieve such goals in the State of the Union address. But most of these initiatives do not consider the fundamental changes that personalized medicine demands. It requires a statutory structure designed for the development of products applicable for small subpopulations that is very different from our current model which is designed for the development of products for large populations. The current approval process is purposely not designed to consider individual efficacy. It is designed to incentivize reduced variation in clinical trials rather than embracing variation. In addition, it is based on twentieth-century notions of disease focused on phenotype rather than on pathophysiologic pathways. Current foci on the development of companion diagnostics, orphan drugs and post-approval study are important but insufficient. FDA does not have the authority to require the type of standardization, clinical trial design and extensive data reporting and sharing that. is needed to achieve the goals for personalized medicine. In addition, FDA's current drug approval process is too lengthy and cumbersome to deal with the iterative responses personalized medicine entails. If we are serious about wanting to achieve these goals, we will need to entertain such fundamental changes in authority.

The early career researcher's toolkit: translating tissue engineering, regenerative medicine and cell therapy products.

PubMed

Rafiq, Qasim A; Ortega, Ilida; Jenkins, Stuart I; Wilson, Samantha L; Patel, Asha K; Barnes, Amanda L; Adams, Christopher F; Delcassian, Derfogail; Smith, David

2015-11-01

Although the importance of translation for the development of tissue engineering, regenerative medicine and cell-based therapies is widely recognized, the process of translation is less well understood. This is particularly the case among some early career researchers who may not appreciate the intricacies of translational research or make decisions early in development which later hinders effective translation. Based on our own research and experiences as early career researchers involved in tissue engineering and regenerative medicine translation, we discuss common pitfalls associated with translational research, providing practical solutions and important considerations which will aid process and product development. Suggestions range from effective project management, consideration of key manufacturing, clinical and regulatory matters and means of exploiting research for successful commercialization.

Excellence in clinical teaching: knowledge transformation and development required.

PubMed

Irby, David M

2014-08-01

Clinical teachers in medicine face the daunting task of mastering the many domains of knowledge needed for practice and teaching. The breadth and complexity of this knowledge continue to increase, as does the difficulty of transforming the knowledge into concepts that are understandable to learners. Properly targeted faculty development has the potential to expedite the knowledge transformation process for clinical teachers. Based on my own research in clinical teaching and faculty development, as well as the work of others, I describe the unique forms of clinical teacher knowledge, the transformation of that knowledge for teaching purposes and implications for faculty development. The following forms of knowledge for clinical teaching in medicine need to be mastered and transformed: (i) knowledge of medicine and patients; (ii) knowledge of context; (iii) knowledge of pedagogy and learners, and (iv) knowledge integrated into teaching scripts. This knowledge is employed and conveyed through the parallel processes of clinical reasoning and clinical instructional reasoning. Faculty development can facilitate this knowledge transformation process by: (i) examining, deconstructing and practising new teaching scripts; (ii) focusing on foundational concepts; (iii) demonstrating knowledge-in-use, and (iv) creating a supportive organisational climate for clinical teaching. To become an excellent clinical teacher in medicine requires the transformation of multiple forms of knowledge for teaching purposes. These domains of knowledge allow clinical teachers to provide tailored instruction to learners at varying levels in the context of fast-paced and demanding clinical practice. Faculty development can facilitate this knowledge transformation process. © 2014 John Wiley & Sons Ltd.

Selection of essential medicines for South Africa - an analysis of in-depth interviews with national essential medicines list committee members.

PubMed

Perumal-Pillay, Velisha Ann; Suleman, Fatima

2017-01-07

The South African (SA) public health system has employed an Essential Medicines List (EML) with Standard Treatment Guidelines (STGs) in the public sector since 1996. To date no studies have reported on the process of selection of essential medicines for SA EMLs and how this may have changed over time. This study reports on the decision making process for the selection of essential medicines for SA EMLs, over the years, as described by various members of the National Essential Medicines List Committee (NEMLC) and their task teams. Qualitative in-depth interviews, guided by an interview questionnaire, were conducted with 11 members of the SA NEMLC and their task teams (both past and present members) during the period January - April 2015. Interviews were recorded and transcribed verbatim. Transcripts were then coded by the first author and verified by the second author before being reconciled and input into NVIVO, a qualitative software, to facilitate analysis of the data. The interviews conducted suggest that the NEMLC process of medicine selection has been refined over the years. This together with the EML review process is now essentially predominantly an evidence based process where quality, safety and efficacy of a medicine is considered first followed by cost considerations which includes pharmacoeconomic evaluations, and pricing of medicines. This is the first study in SA to report on how decisions are taken to include or exclude medicines on SA national EMLs and provides insight into the SA EML medicine selection, review and monitoring processes over time. The results show that the NEMLC has undergone tremendous transformation over the years. Whilst the membership of the committee largely remains unchanged, the committee has developed its policies and processes over the years. However there is still a need to strengthen the monitoring and evaluation aspects of the SA EML policy process.

Person-centred medicines optimisation policy in England: an agenda for research on polypharmacy.

PubMed

Heaton, Janet; Britten, Nicky; Krska, Janet; Reeve, Joanne

2017-01-01

Aim To examine how patient perspectives and person-centred care values have been represented in documents on medicines optimisation policy in England. There has been growing support in England for a policy of medicines optimisation as a response to the rise of problematic polypharmacy. Conceptually, medicines optimisation differs from the medicines management model of prescribing in being based around the patient rather than processes and systems. This critical examination of current official and independent policy documents questions how central the patient is in them and whether relevant evidence has been utilised in their development. A documentary analysis of reports on medicines optimisation published by the Royal Pharmaceutical Society (RPS), The King's Fund and National Institute for Health and Social Care Excellence since 2013. The analysis draws on a non-systematic review of research on patient experiences of using medicines. Findings The reports varied in their inclusion of patient perspectives and person-centred care values, and in the extent to which they drew on evidence from research on patients' experiences of polypharmacy and medicines use. In the RPS report, medicines optimisation is represented as being a 'step change' from medicines management, in contrast to the other documents which suggest that it is facilitated by the systems and processes that comprise the latter model. Only The King's Fund report considered evidence from qualitative studies of people's use of medicines. However, these studies are not without their limitations. We suggest five ways in which researchers could improve this evidence base and so inform the development of future policy: by facilitating reviews of existing research; conducting studies of patient experiences of polypharmacy and multimorbidity; evaluating medicines optimisation interventions; making better use of relevant theories, concepts and tools; and improving patient and public involvement in research and in guideline development.

Development and promotion in translational medicine: perspectives from 2012 sino-american symposium on clinical and translational medicine

PubMed Central

2012-01-01

Background Clinical translational medicine (CTM) is an emerging area comprising multidisciplinary research from basic science to medical applications and entails a close collaboration among hospital, academia and industry. Findings This Session focused discussing on new models for project development and promotion in translational medicine. The conference stimulated the scientific and commercial communication of project development between academies and companies, shared the advanced knowledge and expertise of clinical applications, and created the environment for collaborations. Conclusions Although strategic collaborations between corporate and academic institutions have resulted in a state of resurgence in the market, new cooperation models still need time to tell whether they will improve the translational medicine process. PMID:23369198

Biomarkers as drug development tools: discovery, validation, qualification and use.

PubMed

Kraus, Virginia B

2018-06-01

The 21st Century Cures Act, approved in the USA in December 2016, has encouraged the establishment of the national Precision Medicine Initiative and the augmentation of efforts to address disease prevention, diagnosis and treatment on the basis of a molecular understanding of disease. The Act adopts into law the formal process, developed by the FDA, of qualification of drug development tools, including biomarkers and clinical outcome assessments, to increase the efficiency of clinical trials and encourage an era of molecular medicine. The FDA and European Medicines Agency (EMA) have developed similar processes for the qualification of biomarkers intended for use as companion diagnostics or for development and regulatory approval of a drug or therapeutic. Biomarkers that are used exclusively for the diagnosis, monitoring or stratification of patients in clinical trials are not subject to regulatory approval, although their qualification can facilitate the conduct of a trial. In this Review, the salient features of biomarker discovery, analytical validation, clinical qualification and utilization are described in order to provide an understanding of the process of biomarker development and, through this understanding, convey an appreciation of their potential advantages and limitations.

New developments in education and training in sexual medicine.

PubMed

Reisman, Yacov; Eardley, Ian; Porst, Hartmut

2013-04-01

INTRODUCTION.: The past 12 months have been historic ones for the field of Sexual Medicine in that we have seen the creation of the European Board examination in Sexual Medicine with the title of "Fellow of the European Committee on Sexual Medicine" (FECSM) offered to successful candidates. AIM.: The study aims to promote a high standard of care in Sexual Medicine. METHODS.: An important way of promoting high standards of care is by the development of training, regulation, and assessment framework. The background to these developments and the recent educational activities of the European Society for Sexual Medicine (ESSM) are described in this article. RESULTS.: The creation of the Multidisciplinary Joint Committee on Sexual Medicine (MJCSM) under the auspices of the European Union of Medical Specialists, with the primary purpose to develop the highest possible standards of training in Sexual Medicine in Europe, made it possible to create a process for qualification in Sexual Medicine. The ESSM educational activities created opportunities to support trainees in Sexual Medicine and the first MJCSM exam was held in Amsterdam with a high overall success rate. CONCLUSION.: These activities are intended to improve quality. The FECSM examination is the first of its type and provides a real opportunity for Sexual Medicine physicians to demonstrate and document their knowledge. © 2013 International Society for Sexual Medicine.

[Study on culture and philosophy of processing of traditional Chinese medicines].

PubMed

Yang, Ming; Zhang, Ding-Kun; Zhong, Ling-Yun; Wang, Fang

2013-07-01

According to cultural views and philosophical thoughts, this paper studies the cultural origin, thinking modes, core principles, general regulation and methods of processing, backtracks processing's culture and history which contains generation and deduction process, experienced and promoting process, and core value, summarizes processing's basic principles which are directed by holistic, objective, dynamic, balanced and appropriate thoughts; so as to propagate cultural characteristic and philosophical wisdom of traditional Chinese medicine processing, to promote inheritance and development of processing and to ensure the maximum therapeutic value of Chinese medical clinical.

Personalized medicine and chronic obstructive pulmonary disease.

PubMed

Wouters, E F M; Wouters, B B R A F; Augustin, I M L; Franssen, F M E

2017-05-01

The current review summarizes ongoing developments in personalized medicine and precision medicine in chronic obstructive pulmonary disease (COPD). Our current approach is far away of personalized management algorithms as current recommendations for COPD are largely based on a reductionist disease description, operationally defined by results of spirometry. Besides precision medicine developments, a personalized medicine approach in COPD is described based on a holistic approach of the patient and considering illness as the consequence of dynamic interactions within and between multiple interacting and self-adjusting systems. Pulmonary rehabilitation is described as a model of personalized medicine. Largely based on current understanding of inflammatory processes in COPD, targeted interventions in COPD are reviewed. Augmentation therapy for α-1-antitrypsine deficiency is described as model of precision medicine in COPD based in profound understanding of the related genetic endotype. Future developments of precision medicine in COPD require identification of relevant endotypes combined with proper identification of phenotypes involved in the complex and heterogeneous manifestations of COPD.

Qualitative Exploration of the Potential Causes of Serious Reduction in Availability of Medicinal Plants in the Qinghai-Tibetan High Plateau

PubMed Central

Cuomu, Mingji

2014-01-01

In the last ten years, there has been a dramatic reduction in medicinal plants in Tibet. This situation has attracted the attention of many researchers from different professional backgrounds, yet very few documents have been published on the general theoretical context and the actual process of herb collection as it occurs at different levels in clinics in Tibet. This article begins with a systematic review of the general principles of medicinal plant collection methods as set out in the ancient traditional medical system. Because the demand for plants is generated by the need to make Tibetan medicines, it is necessary to consider the original context of Tibetan medicine to understand pharmacological needs and the principles behind collecting medicinal plants to develop a strategy that might guarantee sustainable development of the plant supply. After considering the wider context of this study, the article presents research mainly based on case studies with the intention of understanding different stakeholders’ experiences and social relationships in the contemporary herb collection process in order to discover behavioral patterns within the dynamic social roles involved in this process as these inform policy formation and to seek to promote appropriate methods in the future. PMID:25478035

[Thinking of study on secondary development of major traditional Chinese medicine varieties based on system theory].

PubMed

Cheng, Xu-Dong; Jia, Xiao-Bin; Feng, Liang; Jiang, Jun

2013-12-01

The secondary development of traditional Chinese medicines (TCMs) is an important content of TCM modernization process, as well as an important path for developing new TCM drugs. Under the guidance of the system theory, in response to the lack of the overall guideline and practical methods for the secondary development of TCMs at present, we introduced the overall thought of the secondary development of major TCM varieties, as well as the roles and contents of clinical research, pharmacology and pharmaceutics in the process of the secondary development of major TCM varieties, so as to provide systematic strategies and methods for the development of major TCM varieties.

Microfabricated Modular Scale-Down Device for Regenerative Medicine Process Development

PubMed Central

Reichen, Marcel; Macown, Rhys J.; Jaccard, Nicolas; Super, Alexandre; Ruban, Ludmila; Griffin, Lewis D.; Veraitch, Farlan S.; Szita, Nicolas

2012-01-01

The capacity of milli and micro litre bioreactors to accelerate process development has been successfully demonstrated in traditional biotechnology. However, for regenerative medicine present smaller scale culture methods cannot cope with the wide range of processing variables that need to be evaluated. Existing microfabricated culture devices, which could test different culture variables with a minimum amount of resources (e.g. expensive culture medium), are typically not designed with process development in mind. We present a novel, autoclavable, and microfabricated scale-down device designed for regenerative medicine process development. The microfabricated device contains a re-sealable culture chamber that facilitates use of standard culture protocols, creating a link with traditional small-scale culture devices for validation and scale-up studies. Further, the modular design can easily accommodate investigation of different culture substrate/extra-cellular matrix combinations. Inactivated mouse embryonic fibroblasts (iMEF) and human embryonic stem cell (hESC) colonies were successfully seeded on gelatine-coated tissue culture polystyrene (TC-PS) using standard static seeding protocols. The microfluidic chip included in the device offers precise and accurate control over the culture medium flow rate and resulting shear stresses in the device. Cells were cultured for two days with media perfused at 300 µl.h−1 resulting in a modelled shear stress of 1.1×10−4 Pa. Following perfusion, hESC colonies stained positively for different pluripotency markers and retained an undifferentiated morphology. An image processing algorithm was developed which permits quantification of co-cultured colony-forming cells from phase contrast microscope images. hESC colony sizes were quantified against the background of the feeder cells (iMEF) in less than 45 seconds for high-resolution images, which will permit real-time monitoring of culture progress in future experiments. The presented device is a first step to harness the advantages of microfluidics for regenerative medicine process development. PMID:23284952

Family medicine training in sub-Saharan Africa: South–South cooperation in the Primafamed project as strategy for development

PubMed Central

Flinkenflögel, Maaike; Essuman, Akye; Chege, Patrick; Ayankogbe, Olayinka; De Maeseneer, Jan

2014-01-01

Background. Health-care systems based on primary health care (PHC) are more equitable and cost effective. Family medicine trains medical doctors in comprehensive PHC with knowledge and skills that are needed to increase quality of care. Family medicine is a relatively new specialty in sub-Saharan Africa. Objective. To explore the extent to which the Primafamed South–South cooperative project contributed to the development of family medicine in sub-Saharan Africa. Methods. The Primafamed (Primary Health Care and Family Medicine Education) project worked together with 10 partner universities in sub-Saharan Africa to develop family medicine training programmes over a period of 2.5 years. A SWOT (strengths, weaknesses, opportunities and threats) analysis was done and the training development from 2008 to 2010 in the different partner universities was analysed. Results. During the 2.5 years of the Primafamed project, all partner universities made progress in the development of their family medicine training programmes. The SWOT analysis showed that at both national and international levels, the time is ripe to train medical doctors in family medicine and to integrate the specialty into health-care systems, although many barriers, including little awareness, lack of funding, low support from other specialists and reserved support from policymakers, are still present. Conclusions. Family medicine can play an important role in health-care systems in sub-Saharan Africa; however, developing a new discipline is challenging. Advocacy, local ownership, action research and support from governments are necessary to develop family medicine and increase its impact. The Primafamed project showed that development of sustainable family medicine training programmes is a feasible but slow process. The South–South cooperation between the ten partners and the South African departments of family medicine strengthened confidence at both national and international levels. PMID:24857843

[Advancements of computer chemistry in separation of Chinese medicine].

PubMed

Li, Lingjuan; Hong, Hong; Xu, Xuesong; Guo, Liwei

2011-12-01

Separating technique of Chinese medicine is not only a key technique in the field of Chinese medicine' s research and development, but also a significant step in the modernization of Chinese medicinal preparation. Computer chemistry can build model and look for the regulations from Chinese medicine system which is full of complicated data. This paper analyzed the applicability, key technology, basic mode and common algorithm of computer chemistry applied in the separation of Chinese medicine, introduced the mathematic mode and the setting methods of Extraction kinetics, investigated several problems which based on traditional Chinese medicine membrane procession, and forecasted the application prospect.

Research on the selection of innovation compound using Possibility Construction Space Theory and fuzzy pattern recognition

NASA Astrophysics Data System (ADS)

Xie, Songhua; Li, Dehua; Nie, Hui

2009-10-01

There are a large number of fuzzy concepts and fuzzy phenomena in traditional Chinese medicine, which have led to great difficulties for study of traditional Chinese medicine. In this paper, the mathematical methods are used to quantify fuzzy concepts of drugs and prescription. We put forward the process of innovation formulations and selection method in Chinese medicine based on the Possibility Construction Space Theory (PCST) and fuzzy pattern recognition. Experimental results show that the method of selecting medicines from a number of characteristics of traditional Chinese medicine is consistent with the basic theory of traditional Chinese medicine. The results also reflect the integrated effects of the innovation compound. Through the use of the innovation formulations system, we expect to provide software tools for developing new traditional Chinese medicine and to inspire traditional Chinese medicine researchers to develop novel drugs.

[Opportunity and challenge of post-marketing evaluation of traditional Chinese medicine].

PubMed

Du, Xiao-Xi; Song, Hai-Bo; Ren, Jing-Tian; Yang, Le; Guo, Xiao-Xin; Pang, Yu

2014-09-01

Post-marketing evaluation is a process which evaluate the risks and benefits of drug clinical application comprehensively and systematically, scientific and systematic results of post-marketing evaluation not only can provide data support for clinical application of traditional Chinese medicine, but also can be a reliable basis for the supervision department to develop risk control measures. With the increasing demands for treatment and prevention of disease, traditional Chinese medicine has been widely used, and security issues are also exposed. How to find risk signal of traditional Chinese medicine in the early stages, carry out targeted evaluation work and control risk timely have become challenges in the development of traditional Chinese medicine industry.

Physicochemical equivalence of generic antihypertensive medicines (EQUIMEDS): protocol for a quality of medicines assessment

PubMed Central

Redfern, Julie; Adedoyin, Rufus Adesoji; Ofori, Sandra; Anchala, Raghupathy; Ajay, Vamadevan S; De Andrade, Luciano; Zelaya, Jose; Kaur, Harparkash; Balabanova, Dina; Sani, Mahmoud U

2016-01-01

Background Prevention and optimal management of hypertension in the general population is paramount to the achievement of the World Heart Federation (WHF) goal of reducing premature cardiovascular disease (CVD) mortality by 25% by the year 2025 and widespread access to good quality antihypertensive medicines is a critical component for achieving the goal. Despite research and evidence relating to other medicines such as antimalarials and antibiotics, there is very little known about the quality of generic antihypertensive medicines in low-income and middle-income countries. The aim of this study was to determine the physicochemical equivalence (percentage of active pharmaceutical ingredient, API) of generic antihypertensive medicines available in the retail market of a developing country. Methods An observational design will be adopted, which includes literature search, landscape assessment, collection and analysis of medicine samples. To determine physicochemical equivalence, a multistage sampling process will be used, including (1) identification of the 2 most commonly prescribed classes of antihypertensive medicines prescribed in Nigeria; (2) identification of a random sample of 10 generics from within each of the 2 most commonly prescribed classes; (3) a geographical representative sampling process to identify a random sample of 24 retail outlets in Nigeria; (4) representative sample purchasing, processing to assess the quality of medicines, storage and transport; and (5) assessment of the physical and chemical equivalence of the collected samples compared to the API in the relevant class. In total, 20 samples from each of 24 pharmacies will be tested (total of 480 samples). Discussion Availability of and access to quality antihypertensive medicines globally is therefore a vital strategy needed to achieve the WHF 25×25 targets. However, there is currently a scarcity of knowledge about the quality of antihypertensive medicines available in developing countries. Such information is important for enforcing and for ensuring the quality of antihypertensive medicines. PMID:28588941

Family Medicine Global Health Fellowship Competencies: A Modified Delphi Study.

PubMed

Rayess, Fadya El; Filip, Anna; Doubeni, Anna; Wilson, Calvin; Haq, Cynthia; Debay, Marc; Anandarajah, Gowri; Heffron, Warren; Jayasekera, Neil; Larson, Paul; Dahlman, Bruce; Valdman, Olga; Hunt, Vince

2017-02-01

Many US medical schools and family medicine departments have responded to a growing interest in global health by developing global health fellowships. However, there are no guidelines or consensus statements outlining competencies for global health fellows. Our objective was to develop a mission and core competencies for Family Medicine Global Health Fellowships. A modified Delphi technique was used to develop consensus on fellowship competencies. A panel, comprised of 13 members with dual expertise in global health and medical education, undertook an iterative consensus process, followed by peer review, from April to December 2014. The panel developed a mission statement and identified six domains for family medicine global health fellowships: patient care, medical knowledge, professionalism, communication and leadership, teaching, and scholarship. Each domain includes a set of core and program-specific competencies. The family medicine global health competencies are intended to serve as an educational framework for the design, implementation, and evaluation of individual family medicine global health fellowship programs.

Benchmarking progress in tackling the challenges of intellectual property, and access to medicines in developing countries.

PubMed Central

Musungu, Sisule F.

2006-01-01

The impact of intellectual property protection in the pharmaceutical sector on developing countries has been a central issue in the fierce debate during the past 10 years in a number of international fora, particularly the World Trade Organization (WTO) and WHO. The debate centres on whether the intellectual property system is: (1) providing sufficient incentives for research and development into medicines for diseases that disproportionately affect developing countries; and (2) restricting access to existing medicines for these countries. The Doha Declaration was adopted at WTO in 2001 and the Commission on Intellectual Property, Innovation and Public Health was established at WHO in 2004, but their respective contributions to tackling intellectual property-related challenges are disputed. Objective parameters are needed to measure whether a particular series of actions, events, decisions or processes contribute to progress in this area. This article proposes six possible benchmarks for intellectual property-related challenges with regard to the development of medicines and ensuring access to medicines in developing countries. PMID:16710545

Development of family medicine in Ukraine.

PubMed

Kolesnyk, Pavlo; Švab, Igor

2013-12-01

This article includes a personal history of a family physician working in Ukraine. In June 2012, Pavlo Kolesnyk, Ukrainian Assistant Professor and a Family Doctor was awarded the second Montegute Scholar grant and had the chance to attend the Wonca Europe Conference 2012 in Vienna. In many developed countries, family medicine is already well established. In Ukraine, which has the legacy of a socialist health care system the implementation of the discipline started only at the end of the last century. The changes in the health care system were of greater importance in primary care and family medicine. It gave greater decentralization of the health care system and supported investment in primary care. This article describes the development of family medicine in undergraduate and postgraduate education. Whilst family medicine is officially a priority of health care policy, there is still a long process ahead. Family medicine needs financial support from the government and doctor's wages have to be increased, to prevent this branch of medicine being unpopular among graduating medical students.

[Discussion on research and development of new traditional Chinese medicine preparation process based on idea of QbD].

PubMed

Feng, Yi; Hong, Yan-Long; Xian, Jie-Chen; Du, Ruo-Fei; Zhao, Li-Jie; Shen, Lan

2014-09-01

Traditional processes are mostly adopted in traditional Chinese medicine (TCM) preparation production and the quality of products is mostly controlled by terminal. Potential problems of the production in the process are unpredictable and is relied on experience in most cases. Therefore, it is hard to find the key points affecting the preparation process and quality control. A pattern of research and development of traditional Chinese medicine preparation process based on the idea of Quality by Design (QbD) was proposed after introducing the latest research achievement. Basic theories of micromeritics and rheology were used to characterize the physical property of TCM raw material. TCM preparation process was designed in a more scientific and rational way by studying the correlation among enhancing physical property of raw material, preparation process and product quality of preparation. So factors affecting the quality of TCM production would be found out and problems that might occur in the pilot process could be predicted. It would be a foundation for the R&D and production of TCM preparation as well as support for the "process control" of TCMIs gradually realized in the future.

[Research & development and evaluation of oral films].

PubMed

Ren, Lian-Jie; Liu, Juan; Ma, Jun-Wei; Yan, Jia-Chen; Yin, Li-Fang

2017-10-01

Oral film is a new type of oral preparation. Due to portability, simple preparation process and good clinical compliance, oral films have become the focus of novel drug delivery system in recent years. Meanwhile, oral films have been gradually used in the development of Chinese medicine preparations. According to the application and approval situation of different types of oral films both at home and abroad in recent years, their research and development status was analyzed, including the basic concept, formulation, manufacturing process and quality control, as well as related progress and development prospects of oral films applied in traditional Chinese medicine. Some suggestions on the technical evaluation of oral films were put forward by considering specific requirements from regulatory agencies. This paper could provide some references for the development and evaluation of oral films. Due to the complexity of the drug substances and the particularity of the drug product, the development and application of oral films in traditional Chinese medicine are still faced with opportunity and challenges. Copyright© by the Chinese Pharmaceutical Association.

Translational research of optical molecular imaging for personalized medicine.

PubMed

Qin, C; Ma, X; Tian, J

2013-12-01

In the medical imaging field, molecular imaging is a rapidly developing discipline and forms many imaging modalities, providing us effective tools to visualize, characterize, and measure molecular and cellular mechanisms in complex biological processes of living organisms, which can deepen our understanding of biology and accelerate preclinical research including cancer study and medicine discovery. Among many molecular imaging modalities, although the penetration depth of optical imaging and the approved optical probes used for clinics are limited, it has evolved considerably and has seen spectacular advances in basic biomedical research and new drug development. With the completion of human genome sequencing and the emergence of personalized medicine, the specific drug should be matched to not only the right disease but also to the right person, and optical molecular imaging should serve as a strong adjunct to develop personalized medicine by finding the optimal drug based on an individual's proteome and genome. In this process, the computational methodology and imaging system as well as the biomedical application regarding optical molecular imaging will play a crucial role. This review will focus on recent typical translational studies of optical molecular imaging for personalized medicine followed by a concise introduction. Finally, the current challenges and the future development of optical molecular imaging are given according to the understanding of the authors, and the review is then concluded.

The Role of Evidence in the Decision-Making Process of Selecting Essential Medicines in Developing Countries: The Case of Tanzania

PubMed Central

Mori, Amani Thomas; Kaale, Eliangiringa Amos; Ngalesoni, Frida; Norheim, Ole Frithjof; Robberstad, Bjarne

2014-01-01

Background Insufficient access to essential medicines is a major health challenge in developing countries. Despite the importance of Standard Treatment Guidelines and National Essential Medicine Lists in facilitating access to medicines, little is known about how they are updated. This study aims to describe the process of updating the Standard Treatment Guidelines and National Essential Medicine List in Tanzania and further examines the criteria and the underlying evidence used in decision-making. Methods This is a qualitative study in which data were collected by in-depth interviews and document reviews. Interviews were conducted with 18 key informants who were involved in updating the Standard Treatment Guidelines and National Essential Medicine List. We used a thematic content approach to analyse the data. Findings The Standard Treatment Guidelines and National Essential Medicine List was updated by committees of experts who were recruited mostly from referral hospitals and the Ministry of Health and Social Welfare. Efficacy, safety, availability and affordability were the most frequently utilised criteria in decision-making, although these were largely based on experience rather than evidence. In addition, recommendations from international guidelines and medicine promotions also influenced decision-making. Cost-effectiveness, despite being an important criterion for formulary decisions, was not utilised. Conclusions Recent decisions about the selection of essential medicines in Tanzania were made by committees of experts who largely used experience and discretionary judgement, leaving evidence with only a limited role in decision-making process. There may be several reasons for the current limited use of evidence in decision-making, but one hypothesis that remains to be explored is whether training experts in evidence-based decision-making would lead to a better and more explicit use of evidence. PMID:24416293

The role of evidence in the decision-making process of selecting essential medicines in developing countries: the case of Tanzania.

PubMed

Mori, Amani Thomas; Kaale, Eliangiringa Amos; Ngalesoni, Frida; Norheim, Ole Frithjof; Robberstad, Bjarne

2014-01-01

Insufficient access to essential medicines is a major health challenge in developing countries. Despite the importance of Standard Treatment Guidelines and National Essential Medicine Lists in facilitating access to medicines, little is known about how they are updated. This study aims to describe the process of updating the Standard Treatment Guidelines and National Essential Medicine List in Tanzania and further examines the criteria and the underlying evidence used in decision-making. This is a qualitative study in which data were collected by in-depth interviews and document reviews. Interviews were conducted with 18 key informants who were involved in updating the Standard Treatment Guidelines and National Essential Medicine List. We used a thematic content approach to analyse the data. The Standard Treatment Guidelines and National Essential Medicine List was updated by committees of experts who were recruited mostly from referral hospitals and the Ministry of Health and Social Welfare. Efficacy, safety, availability and affordability were the most frequently utilised criteria in decision-making, although these were largely based on experience rather than evidence. In addition, recommendations from international guidelines and medicine promotions also influenced decision-making. Cost-effectiveness, despite being an important criterion for formulary decisions, was not utilised. Recent decisions about the selection of essential medicines in Tanzania were made by committees of experts who largely used experience and discretionary judgement, leaving evidence with only a limited role in decision-making process. There may be several reasons for the current limited use of evidence in decision-making, but one hypothesis that remains to be explored is whether training experts in evidence-based decision-making would lead to a better and more explicit use of evidence.

Recruiting Faculty Leaders at U.S. Medical Schools: A Process Without Improvement?

PubMed

Marsh, James D; Chod, Ronald

2017-11-01

Recruiting faculty leaders to work in colleges of medicine is a ubiquitous, time-consuming, costly activity. Little quantitative information is available about contemporary leadership recruiting processes and outcomes. In this article, the authors examine current recruiting methods and outcomes in colleges of medicine and compare academic search approaches with the approaches often employed in intellectual-capital-rich industries.In 2015, the authors surveyed chairs of internal medicine at U.S. medical schools regarding their recruiting practices and outcomes-specifically their selection methods, the duration of searches, the recruitment of women and minorities underrepresented in medicine (URM), and their satisfaction with search outcomes.The authors found that department chairs were extensively engaged in numerous searches for leaders. The recruitment process most commonly required 7 to 12 months from initiation to signed contract. Interestingly, longer searches (19+ months) were much more frequently associated with a recruitment outcome that chairs viewed as unsatisfactory or very unsatisfactory. Most leadership searches produced very few women and URM finalists. The biggest perceived hurdles to successful recruitment were the need to relocate the candidate and family and the shortage of good candidates.The process of recruiting leaders in academic medicine has changed little in more than 25 years. Process improvement is important and should entail carefully structured search processes, including both an overhaul of search committees and further emphasis on leadership development within the college of medicine. The authors propose specific steps to enhance recruitment of members of URM groups and women to leadership positions in academic medicine.

The remote supervisory and controlling experiment system of traditional Chinese medicine production based on Fieldbus

NASA Astrophysics Data System (ADS)

Zhan, Jinliang; Lu, Pei

2006-11-01

Since the quality of traditional Chinese medicine products are affected by raw material, machining and many other factors, it is difficult for traditional Chinese medicine production process especially the extracting process to ensure the steady and homogeneous quality. At the same time, there exist some quality control blind spots due to lacking on-line quality detection means. But if infrared spectrum analysis technology was used in traditional Chinese medicine production process on the basis of off-line analysis to real-time detect the quality of semi-manufactured goods and to be assisted by advanced automatic control technique, the steady and homogeneous quality can be obtained. It can be seen that the on-line detection of extracting process plays an important role in the development of Chinese patent medicines industry. In this paper, the design and implement of a traditional Chinese medicine extracting process monitoring experiment system which is based on PROFIBUS-DP field bus, OPC, and Internet technology is introduced. The system integrates intelligence node which gathering data, superior sub-system which achieving figure configuration and remote supervisory, during the process of traditional Chinese medicine production, monitors the temperature parameter, pressure parameter, quality parameter etc. And it can be controlled by the remote nodes in the VPN (Visual Private Network). Experiment and application do have proved that the system can reach the anticipation effect fully, and with the merits of operational stability, real-time, reliable, convenient and simple manipulation and so on.

Developing and implementing core competencies for integrative medicine fellowships.

PubMed

Ring, Melinda; Brodsky, Marc; Low Dog, Tieraona; Sierpina, Victor; Bailey, Michelle; Locke, Amy; Kogan, Mikhail; Rindfleisch, James A; Saper, Robert

2014-03-01

The Consortium of Academic Health Centers for Integrative Medicine defines integrative medicine as "the practice of medicine that reaffirms the importance of the relationship between practitioner and patient, focuses on the whole person, is informed by evidence, and makes use of all appropriate therapeutic approaches, health care professionals, and disciplines to achieve optimal health and healing." Over the past three decades, the U.S. public increasingly has sought integrative medicine approaches. In an effort to train medical professionals to adequately counsel patients on the safe and appropriate use of these approaches, medical schools and residencies have developed curricula on integrative medicine for their trainees. In addition, integrative medicine clinical fellowships for postresidency physicians have emerged to provide training for practitioners interested in gaining greater expertise in this emerging field. Currently, 13 clinical fellowships in integrative medicine exist in the United States, and they are predominantly connected to academic medical centers or teaching affiliate hospitals. In 2010, the Consortium of Academic Health Centers for Integrative Medicine, represented by 56 member academic health care institutions with a shared commitment to advance the principles and practices of integrative medicine, convened a two-year task force to draft integrative medicine fellowship core competencies. These competencies would guide fellowship curriculum development and ensure that graduates possessed a common body of knowledge, skills, and attitudes. In this article, the authors discuss the competencies and the task force's process to develop them, as well as associated teaching and assessment methods, faculty development, potential barriers, and future directions.

Recommended integrative medicine competencies for family medicine residents.

PubMed

Locke, Amy B; Gordon, Andrea; Guerrera, Mary P; Gardiner, Paula; Lebensohn, Patricia

2013-01-01

The use of complementary and alternative medicine (CAM) and Integrative Medicine (IM) has grown steadily over the past decade. Patients seek physician guidance, yet physicians typically have limited knowledge and training. There is some coverage of IM/CAM topics in medical schools and residencies but with little coordination or consistency. In 2008, the Society of Teachers of Family Medicine (STFM) group on Integrative Medicine began the process of designing a set of competencies to educate Family Medicine residents in core concepts of IM. The goal was creation of a set of nationally recognized competencies tied to the Accreditation Council for Graduate Medical Education (ACGME) domains. These competencies were to be achievable by diverse programs, including those without significant internal resources. The group compiled existing curricula from programs around the country and distilled these competencies through multiple reviews and discussions. Simultaneously, the Integrative Medicine in Residency program run by the University of Arizona underwent a similar process. In 2009, these competencies were combined and further developed at the STFM annual meeting by a group of experts. In 2010, the STFM Board approved 19 measurable competencies, each categorized by ACGME domain, as recommended for Family Medicine residencies. Programs have implemented these competencies in various ways given individual needs and resources. This paper reviews the development of IM competencies for residency education in Family Medicine and presents those endorsed by STFM. By educating physicians in training about IM/CAM via competency-based curricula, we aim to promote comprehensive patient-centered care. © 2013 Elsevier Inc. All rights reserved.

A web-based knowledge management system integrating Western and Traditional Chinese Medicine for relational medical diagnosis.

PubMed

Herrera-Hernandez, Maria C; Lai-Yuen, Susana K; Piegl, Les A; Zhang, Xiao

2016-10-26

This article presents the design of a web-based knowledge management system as a training and research tool for the exploration of key relationships between Western and Traditional Chinese Medicine, in order to facilitate relational medical diagnosis integrating these mainstream healing modalities. The main goal of this system is to facilitate decision-making processes, while developing skills and creating new medical knowledge. Traditional Chinese Medicine can be considered as an ancient relational knowledge-based approach, focusing on balancing interrelated human functions to reach a healthy state. Western Medicine focuses on specialties and body systems and has achieved advanced methods to evaluate the impact of a health disorder on the body functions. Identifying key relationships between Traditional Chinese and Western Medicine opens new approaches for health care practices and can increase the understanding of human medical conditions. Our knowledge management system was designed from initial datasets of symptoms, known diagnosis and treatments, collected from both medicines. The datasets were subjected to process-oriented analysis, hierarchical knowledge representation and relational database interconnection. Web technology was implemented to develop a user-friendly interface, for easy navigation, training and research. Our system was prototyped with a case study on chronic prostatitis. This trial presented the system's capability for users to learn the correlation approach, connecting knowledge in Western and Traditional Chinese Medicine by querying the database, mapping validated medical information, accessing complementary information from official sites, and creating new knowledge as part of the learning process. By addressing the challenging tasks of data acquisition and modeling, organization, storage and transfer, the proposed web-based knowledge management system is presented as a tool for users in medical training and research to explore, learn and update relational information for the practice of integrated medical diagnosis. This proposal in education has the potential to enable further creation of medical knowledge from both Traditional Chinese and Western Medicine for improved care providing. The presented system positively improves the information visualization, learning process and knowledge sharing, for training and development of new skills for diagnosis and treatment, and a better understanding of medical diseases. © IMechE 2016.

[Effect and regulation of drying on quality of traditional Chinese medicine pills].

PubMed

Qi, Ya-Ru; Li, Yuan-Hui; Han, Li; Wu, Zhen-Feng; Yue, Peng-Fei; Wang, Xue-Cheng; Xiong, Yao-Kun; Yang, Ming

2017-06-01

The dry quality of traditional Chinese medicine pills is the hot spot of pills research, because their quality has a crucial effect on the efficacy and development of dosage forms. Through literature research and statistical analysis, we would review the current problems on the drying of traditional Chinese medicine pills in this paper, and surrounding the evaluation system for traditional Chinese medicine pills, analyze the characteristics of common drying equipment and processes as well as their effect on quality of pills, discuss the problems in drying equipment and process as well as quality, and put forward the corresponding strategies, hoping to provide new ideas and new methods for the quality improvement of traditional Chinese medicine pills and quality standards. Copyright© by the Chinese Pharmaceutical Association.

[Research progress on breeding standard of medicinal animals and discussion on several key problems].

PubMed

Zhou, Yi-Quan; Qu, Xian-You; Yang, Guang; Li, Jun-de; Su, Yan; Li, Ying

2016-12-01

Medicinal animal breeding standards is regarded as the law to normalize relevant production that can guarantee the quality of traditional Chinese medicine of animal category. The article summarized the medicinal animal resources in our country and the present condition of medicinal animal breeding standards. It considered the current animal breeding standards system was in adequate, not only the quantity of breeding standards, the standard content and index were also uncomprehensive, which is not conducive to the scientific and orderly development and utilization of medicinal animal resources. The article pointed out that the development of the basic standards, environmental control, feed quality, raising management, inspection and quarantine should be included into the medicinal animal breeding standards, and the medicinal animal breeding standards content framework was introduced. Meanwhile, animal welfare, biological safety and file management should be concerned during the process of research. Hope the article has good reference value to medicinal animal breeding standards establishment and production management. Copyright© by the Chinese Pharmaceutical Association.

Defining competency-based evaluation objectives in family medicine

PubMed Central

Lawrence, Kathrine; Allen, Tim; Brailovsky, Carlos; Crichton, Tom; Bethune, Cheri; Donoff, Michel; Laughlin, Tom; Wetmore, Stephen; Carpentier, Marie-Pierre; Visser, Shaun

2011-01-01

Abstract Objective To develop key features for priority topics previously identified by the College of Family Physicians of Canada that, together with skill dimensions and phases of the clinical encounter, broadly describe competence in family medicine. Design Modified nominal group methodology, which was used to develop key features for each priority topic through an iterative process. Setting The College of Family Physicians of Canada. Participants An expert group of 7 family physicians and 1 educational consultant, all of whom had experience in assessing competence in family medicine. Group members represented the Canadian family medicine context with respect to region, sex, language, community type, and experience. Methods The group used a modified Delphi process to derive a detailed operational definition of competence, using multiple iterations until consensus was achieved for the items under discussion. The group met 3 to 4 times a year from 2000 to 2007. Main findings The group analyzed 99 topics and generated 773 key features. There were 2 to 20 (average 7.8) key features per topic; 63% of the key features focused on the diagnostic phase of the clinical encounter. Conclusion This project expands previous descriptions of the process of generating key features for assessment, and removes this process from the context of written examinations. A key-features analysis of topics focuses on higher-order cognitive processes of clinical competence. The project did not define all the skill dimensions of competence to the same degree, but it clearly identified those requiring further definition. This work generates part of a discipline-specific, competency-based definition of family medicine for assessment purposes. It limits the domain for assessment purposes, which is an advantage for the teaching and assessment of learners. A validation study on the content of this work would ensure that it truly reflects competence in family medicine. PMID:21998245

Fostering Competence in Medicines Development: The IFAPP Perspective.

PubMed

Dubois, Dominique J; Jurczynska, Anna; Kerpel-Fronius, Sandor; Kesselring, Gustavo; Imamura, Kyoko; Nell, Gerfried; Silva, Honorio; Stonier, Peter

2016-01-01

IFAPP (International Federation of Associations of Pharmaceutical Physicians and Pharmaceutical Medicine) is a nonprofit organization with the mission to promote Pharmaceutical Medicine & Medicines Development (PM&MD) by enhancing the competencies and maintaining high research ethical standards of Pharmaceutical Physicians and other professionals involved in medicines development worldwide, leading to the availability and appropriate use of medicines for the benefit of patients and society. About 30 national professional associations related to PM&MD, involving 7000 professionals, are affiliated to IFAPP. Medicines development has traditionally been a challenging enterprise, with high risk, high investment, and potentially high returns in the lengthy and complex process of identifying a new chemical entity as a candidate for development and possibly succeeding in bringing it as a pharmaceutical product to the market. However, the emergence of genomics, translational research, biomarkers, and precision medicine pose challenges going forward involving allocation of resources, price, market access, and cost-effectiveness as opposed to the traditional concepts of "efficacy" and "safety." Education and Continuing Professional Development (CPD) are a major focus of IFAPP. The International Conference on Pharmaceutical Medicine (ICPM) is the largest event for our organization; ICPM is held every 2 or 3 years and is aimed to provide the state of the art in key areas for our discipline and profession. The paper is a reflection on the role of competency-based education and training for Pharmaceutical Physicians and medicines development scientists, as was discussed during the recent ICPM 2016 held in Sao Paulo, Brazil on April 18-19, with the support of the Brazilian Association of Pharmaceutical Medicine, and gathered around 200 representatives from the pharmaceutical, clinical research and regulatory arenas from all over the world , .

A review of the information-gathering process for the provision of medicines for self-medication via community pharmacies in developing countries.

PubMed

Brata, Cecilia; Gudka, Sajni; Schneider, Carl R; Everett, Alan; Fisher, Colleen; Clifford, Rhonda M

2013-01-01

Currently, no review has been completed regarding the information-gathering process for the provision of medicines for self-medication in community pharmacies in developing countries. To review the rate of information gathering and the types of information gathered when patients present for self-medication requests. Six databases were searched for studies that described the rate of information gathering and/or the types of information gathered in the provision of medicines for self-medication in community pharmacies in developing countries. The types of information reported were classified as: signs and symptoms, patient identity, action taken, medications, medical history, and others. Twenty-two studies met the inclusion criteria. Variations in the study populations, types of scenarios, research methods, and data reporting were observed. The reported rate of information gathering varied from 18% to 97%, depending on the research methods used. Information on signs and symptoms and patient identity was more frequently reported to be gathered compared with information on action taken, medications, and medical history. Evidence showed that the information-gathering process for the provision of medicines for self-medication via community pharmacies in developing countries is inconsistent. There is a need to determine the barriers to appropriate information-gathering practice as well as to develop strategies to implement effective information-gathering processes. It is also recommended that international and national pharmacy organizations, including pharmacy academics and pharmacy researchers, develop a consensus on the types of information that should be reported in the original studies. This will facilitate comparison across studies so that areas that need improvement can be identified. Copyright © 2013 Elsevier Inc. All rights reserved.

[Application progress on near infrared spectroscopy in quality control and process monitoring of traditional Chinese medicine].

PubMed

Li, Wenlong; Qu, Haibin

2017-01-25

The industry of traditional Chinese medicine (TCM) encounters problems like quality fluctuation of raw materials and unstandardized production process. Near infrared (NIR) spectroscopy technology is widely used in quality control of TCM because of its abundant information, fast and nondestructive characters. The main applications include quantitative analysis of Chinese medicinal materials, intermediates and Chinese patent medicines; the authenticity of TCM, species, origins and manufacturers; monitoring and control of the extraction, alcohol precipitation, column chromatography and blending process. This article reviews the progress on the application of NIR spectroscopy technology in TCM field. In view of the problems existing in the application, the article proposes that the standardization of NIR analysis method should be developed according to specific characteristics of TCM, which will promote the application of NIR technology in the TCM industry.

Framing access to medicines in developing countries: an analysis of media coverage of Canada's Access to Medicines Regime.

PubMed

Esmail, Laura C; Phillips, Kaye; Kuek, Victoria; Cosio, Andrea Perez; Kohler, Jillian Clare

2010-01-04

In September 2003, the Canadian government committed to developing legislation that would facilitate greater access to affordable medicines for developing countries. Over the course of eight months, the legislation, now known as Canada's Access to Medicines Regime (CAMR), went through a controversial policy development process and the newspaper media was one of the major venues in which the policy debates took place. The purpose of this study was to examine how the media framed CAMR to determine how policy goals were conceptualized, which stakeholder interests controlled the public debate and how these variables related to the public policy process. We conducted a qualitative content analysis of newspaper coverage of the CAMR policy and implementation process from 2003-2008. The primary theoretical framework for this study was framing theory. A total of 90 articles from 11 Canadian newspapers were selected for inclusion in our analysis. A team of four researchers coded the articles for themes relating to access to medicines and which stakeholders' voice figured more prominently on each issue. Stakeholders examined included: the research-based industry, the generic industry, civil society, the Canadian government, and developing country representatives. The most frequently mentioned themes across all documents were the issues of drug affordability, intellectual property, trade agreements and obligations, and development. Issues such as human rights, pharmaceutical innovation, and economic competitiveness got little media representation. Civil society dominated the media contents, followed far behind by the Canadian government, the research-based and generic pharmaceutical industries. Developing country representatives were hardly represented in the media. Media framing obscured the discussion of some of the underlying policy goals in this case and failed to highlight issues which are now significant barriers to the use of the legislation. Using the media to engage the public in more in-depth exploration of the policy issues at stake may contribute to a more informed policy development process. The media can be an effective channel for those stakeholders with a weaker voice in policy deliberations to raise public attention to particular issues; however, the political and institutional context must be taken into account as it may outweigh media framing effects.

Electronic fetal monitoring: family medicine obstetrics.

PubMed

Rodney, John R M; Huntley, Benjamin J F; Rodney, Wm Macmillan

2012-03-01

Electronic fetal monitoring assesses fetal health during the prenatal and intrapartum process. Intermittent auscultation does not detect key elements of fetal risk, such as beat-to-beat variability. Family medicine obstetric fellowships have contributed new knowledge to this process by articulating a method of analysis that builds on evidence-based recommendations from the American College of Obstetrics and Gynecology as well as the National Institute of Child Health and Development. This article summarizes the development, interpretation, and management of electronic fetal heart rate patterns and tracings. Copyright © 2012 Elsevier Inc. All rights reserved.

Development of a Chinese medicine assessment measure: an interdisciplinary approach using the delphi method.

PubMed

Schnyer, Rosa N; Conboy, Lisa A; Jacobson, Eric; McKnight, Patrick; Goddard, Thomas; Moscatelli, Francesca; Legedza, Anna T R; Kerr, Catherine; Kaptchuk, Ted J; Wayne, Peter M

2005-12-01

The diagnostic framework and clinical reasoning process in Chinese medicine emphasizes the contextual and qualitative nature of a patient's illness. Chinese medicine assessment data may help interpret clinical outcomes. As part of a study aimed at assessing the validity and improving the inter-rater reliability of the Chinese diagnostic process, a structured assessment instrument was developed for use in clinical trials of acupuncture and other Chinese medical therapies. To foster collaboration and maximize resources and information, an interdisciplinary advisory team was assembled. Under the guidance of two group process facilitators, and in order to establish whether the assessment instrument was consistent with accepted Chinese medicine diagnostic categories (face validity) and included the full range of each concept's meaning (content validity), a panel of Traditional Chinese Medicine (TCM) expert clinicians was convened and their responses were organized using the Delphi process, an iterative, anonymous, idea-generating and consensus-building process. An aggregate rating measure was obtained by taking the mean of mean ratings for each question across all 10 experts. Over three rounds, the overall rating increased from 7.4 (SD = 1.3) in Round 1 to 9.1 (SD = 0.5) in Round 3. The level of agreement among clinicians was measured by a decrease in SD. The final instrument TEAMSI-TCM (Traditional East Asian Medicine Structured Interview, TCM version) uses the pattern differentiation model characteristic of TCM. This modular, dynamic version was specifically designed to assess women, with a focus on gynecologic conditions; with modifications it can be adapted for use with other populations and conditions. TEAMSI-TCM is a prescriptive instrument that guides clinicians to use the proper indicators, combine them in a systematic manner, and generate conclusions. In conjunction with treatment manualization and training it may serve to increase inter-rater reliability and inter-trial reproducibility in Chinese medicine clinical trials. Testing of the validity and reliability of this instrument currently is underway.

[Application of image recognition technology in census of national traditional Chinese medicine resources].

PubMed

Zhang, Xiao-Bo; Ge, Xiao-Guang; Jin, Yan; Shi, Ting-Ting; Wang, Hui; Li, Meng; Jing, Zhi-Xian; Guo, Lan-Ping; Huang, Lu-Qi

2017-11-01

With the development of computer and image processing technology, image recognition technology has been applied to the national medicine resources census work at all stages.Among them: ①In the preparatory work, in order to establish a unified library of traditional Chinese medicine resources, using text recognition technology based on paper materials, be the assistant in the digitalization of various categories related to Chinese medicine resources; to determine the representative area and plots of the survey from each census team, based on the satellite remote sensing image and vegetation map and other basic data, using remote sensing image classification and other technical methods to assist in determining the key investigation area. ②In the process of field investigation, to obtain the planting area of Chinese herbal medicine was accurately, we use the decision tree model, spectral feature and object-oriented method were used to assist the regional identification and area estimation of Chinese medicinal materials.③In the process of finishing in the industry, in order to be able to relatively accurately determine the type of Chinese medicine resources in the region, based on the individual photos of the plant, the specimens and the name of the use of image recognition techniques, to assist the statistical summary of the types of traditional Chinese medicine resources. ④In the application of the results of transformation, based on the pharmaceutical resources and individual samples of medicinal herbs, the development of Chinese medicine resources to identify APP and authentic herbs 3D display system, assisted the identification of Chinese medicine resources and herbs identification characteristics. The introduction of image recognition technology in the census of Chinese medicine resources, assisting census personnel to carry out related work, not only can reduce the workload of the artificial, improve work efficiency, but also improve the census results of information technology and sharing application ability. With the deepening of the work of Chinese medicine resources census, image recognition technology in the relevant work will also play its unique role. Copyright© by the Chinese Pharmaceutical Association.

[Metabolomics research of medicinal plants].

PubMed

Duan, Li-Xin; Dai, Yun-Tao; Sun, Chao; Chen, Shi-Lin

2016-11-01

Metabolomics is the comprehensively study of chemical processes involving small molecule metabolites. It is an important part of systems biology, and is widely applied in complex traditional Chinese medicine（TCM）system. Metabolites biosynthesized by medicinal plants are the effective basis for TCM. Metabolomics studies of medicinal plants will usher in a new period of vigorous development with the implementation of Herb Genome Program and the development of TCM synthetic biology. This manuscript introduces the recent research progresses of metabolomics technology and the main research contents of metabolomics studies for medicinal plants, including identification and quality evaluation for medicinal plants, cultivars breeding, stress resistance, metabolic pathways, metabolic network, metabolic engineering and synthetic biology researches. The integration of genomics, transcriptomics and metabolomics approaches will finally lay foundation for breeding of medicinal plants, R&D, quality and safety evaluation of innovative drug. Copyright© by the Chinese Pharmaceutical Association.

Exploration of the Medicinal Peptide Space.

PubMed

Gevaert, Bert; Stalmans, Sofie; Wynendaele, Evelien; Taevernier, Lien; Bracke, Nathalie; D'Hondt, Matthias; De Spiegeleer, Bart

2016-01-01

The chemical properties of peptide medicines, known as the 'medicinal peptide space' is considered a multi-dimensional subset of the global peptide space, where each dimension represents a chemical descriptor. These descriptors can be linked to biofunctional, medicinal properties to varying degrees. Knowledge of this space can increase the efficiency of the peptide-drug discovery and development process, as well as advance our understanding and classification of peptide medicines. For 245 peptide drugs, already available on the market or in clinical development, multivariate dataexploration was performed using peptide relevant physicochemical descriptors, their specific peptidedrug target and their clinical use. Our retrospective analysis indicates that clusters in the medicinal peptide space are located in a relatively narrow range of the physicochemical space: dense and empty regions were found, which can be explored for the discovery of novel peptide drugs.

Managing the innovation supply chain to maximize personalized medicine.

PubMed

Waldman, S A; Terzic, A

2014-02-01

Personalized medicine epitomizes an evolving model of care tailored to the individual patient. This emerging paradigm harnesses radical technological advances to define each patient's molecular characteristics and decipher his or her unique pathophysiological processes. Translated into individualized algorithms, personalized medicine aims to predict, prevent, and cure disease without producing therapeutic adverse events. Although the transformative power of personalized medicine is generally recognized by physicians, patients, and payers, the complexity of translating discoveries into new modalities that transform health care is less appreciated. We often consider the flow of innovation and technology along a continuum of discovery, development, regulation, and application bridging the bench with the bedside. However, this process also can be viewed through a complementary prism, as a necessary supply chain of services and providers, each making essential contributions to the development of the final product to maximize value to consumers. Considering personalized medicine in this context of supply chain management highlights essential points of vulnerability and/or scalability that can ultimately constrain translation of the biological revolution or potentiate it into individualized diagnostics and therapeutics for optimized value creation and delivery.

Developing a curriculum framework for global health in family medicine: emerging principles, competencies, and educational approaches.

PubMed

Redwood-Campbell, Lynda; Pakes, Barry; Rouleau, Katherine; MacDonald, Colla J; Arya, Neil; Purkey, Eva; Schultz, Karen; Dhatt, Reena; Wilson, Briana; Hadi, Abdullahel; Pottie, Kevin

2011-07-22

Recognizing the growing demand from medical students and residents for more comprehensive global health training, and the paucity of explicit curricula on such issues, global health and curriculum experts from the six Ontario Family Medicine Residency Programs worked together to design a framework for global health curricula in family medicine training programs. A working group comprised of global health educators from Ontario's six medical schools conducted a scoping review of global health curricula, competencies, and pedagogical approaches. The working group then hosted a full day meeting, inviting experts in education, clinical care, family medicine and public health, and developed a consensus process and draft framework to design global health curricula. Through a series of weekly teleconferences over the next six months, the framework was revised and used to guide the identification of enabling global health competencies (behaviours, skills and attitudes) for Canadian Family Medicine training. The main outcome was an evidence-informed interactive framework http://globalhealth.ennovativesolution.com/ to provide a shared foundation to guide the design, delivery and evaluation of global health education programs for Ontario's family medicine residency programs. The curriculum framework blended a definition and mission for global health training, core values and principles, global health competencies aligning with the Canadian Medical Education Directives for Specialists (CanMEDS) competencies, and key learning approaches. The framework guided the development of subsequent enabling competencies. The shared curriculum framework can support the design, delivery and evaluation of global health curriculum in Canada and around the world, lay the foundation for research and development, provide consistency across programmes, and support the creation of learning and evaluation tools to align with the framework. The process used to develop this framework can be applied to other aspects of residency curriculum development.

Developing a curriculum framework for global health in family medicine: emerging principles, competencies, and educational approaches

PubMed Central

2011-01-01

Background Recognizing the growing demand from medical students and residents for more comprehensive global health training, and the paucity of explicit curricula on such issues, global health and curriculum experts from the six Ontario Family Medicine Residency Programs worked together to design a framework for global health curricula in family medicine training programs. Methods A working group comprised of global health educators from Ontario's six medical schools conducted a scoping review of global health curricula, competencies, and pedagogical approaches. The working group then hosted a full day meeting, inviting experts in education, clinical care, family medicine and public health, and developed a consensus process and draft framework to design global health curricula. Through a series of weekly teleconferences over the next six months, the framework was revised and used to guide the identification of enabling global health competencies (behaviours, skills and attitudes) for Canadian Family Medicine training. Results The main outcome was an evidence-informed interactive framework http://globalhealth.ennovativesolution.com/ to provide a shared foundation to guide the design, delivery and evaluation of global health education programs for Ontario's family medicine residency programs. The curriculum framework blended a definition and mission for global health training, core values and principles, global health competencies aligning with the Canadian Medical Education Directives for Specialists (CanMEDS) competencies, and key learning approaches. The framework guided the development of subsequent enabling competencies. Conclusions The shared curriculum framework can support the design, delivery and evaluation of global health curriculum in Canada and around the world, lay the foundation for research and development, provide consistency across programmes, and support the creation of learning and evaluation tools to align with the framework. The process used to develop this framework can be applied to other aspects of residency curriculum development. PMID:21781319

Translational medicine: science or wishful thinking?

PubMed Central

Wehling, Martin

2008-01-01

"Translational medicine" as a fashionable term is being increasingly used to describe the wish of biomedical researchers to ultimately help patients. Despite increased efforts and investments into R&D, the output of novel medicines has been declining dramatically over the past years. Improvement of translation is thought to become a remedy as one of the reasons for this widening gap between input and output is the difficult transition between preclinical ("basic") and clinical stages in the R&D process. Animal experiments, test tube analyses and early human trials do simply not reflect the patient situation well enough to reliably predict efficacy and safety of a novel compound or device. This goal, however, can only be achieved if the translational processes are scientifically backed up by robust methods some of which still need to be developed. This mainly relates to biomarker development and predictivity assessment, biostatistical methods, smart and accelerated early human study designs and decision algorithms among other features. It is therefore claimed that a new science needs to be developed called 'translational science in medicine'. PMID:18559092

Medicine in the 21st century: recommended essential geriatrics competencies for internal medicine and family medicine residents.

PubMed

Williams, Brent C; Warshaw, Gregg; Fabiny, Anne Rebecca; Lundebjerg Mpa, Nancy; Medina-Walpole, Annette; Sauvigne, Karen; Schwartzberg, Joanne G; Leipzig, Rosanne M

2010-09-01

Physician workforce projections by the Institute of Medicine require enhanced training in geriatrics for all primary care and subspecialty physicians. Defining essential geriatrics competencies for internal medicine and family medicine residents would improve training for primary care and subspecialty physicians. The objectives of this study were to (1) define essential geriatrics competencies common to internal medicine and family medicine residents that build on established national geriatrics competencies for medical students, are feasible within current residency programs, are assessable, and address the Accreditation Council for Graduate Medical Education competencies; and (2) involve key stakeholder organizations in their development and implementation. Initial candidate competencies were defined through small group meetings and a survey of more than 100 experts, followed by detailed item review by 26 program directors and residency clinical educators from key professional organizations. Throughout, an 8-member working group made revisions to maintain consistency and compatibility among the competencies. Support and participation by key stakeholder organizations were secured throughout the project. The process identified 26 competencies in 7 domains: Medication Management; Cognitive, Affective, and Behavioral Health; Complex or Chronic Illness(es) in Older Adults; Palliative and End-of-Life Care; Hospital Patient Safety; Transitions of Care; and Ambulatory Care. The competencies map directly onto the medical student geriatric competencies and the 6 Accreditation Council for Graduate Medical Education Competencies. Through a consensus-building process that included leadership and members of key stakeholder organizations, a concise set of essential geriatrics competencies for internal medicine and family medicine residencies has been developed. These competencies are well aligned with concerns for residency training raised in a recent Medicare Payment Advisory Commission report to Congress. Work is underway through stakeholder organizations to disseminate and assess the competencies among internal medicine and family medicine residency programs.

[Verbundweiterbildung(plus) Baden-Württemberg: Development of educational meetings and implications for the implementation of family medicine training programmes in Germany].

PubMed

Flum, Elisabeth; Magez, Julia; Aluttis, Frank; Hoffmann, Mariell; Joos, Stefanie; Ledig, Thomas; Oeljeklaus, Lydia; Simon, Monica; Szecsenyi, Joachim; Steinhäuser, Jost

2016-01-01

The German Society of General Practice and Family Medicine (DEGAM) has defined educational seminars during post-graduate training as a core element to improve trainees' specific knowledge and competencies. Furthermore, these seminars facilitate networking among trainees and support the process of identity formation in family medicine. Since its implementation in 2009, the Verbundweiterbildung(plus) Baden-Württemberg (VWB(plus) Ba-Wü) has offered educational seminars. Aim of this article is to analyse the content of these educational seminars and to derive implications for other family medicine training programmes in Germany. From 2009 to 2015, the data from all educational seminars was descriptively analysed. Furthermore, two researchers categorised the seminar contents independently of each other and assigned them to the competence-based curriculum for family medicine training (Kompetenzbasiertes Curriculum Allgemeinmedizin, KCA). Until 2015, 600 trainees participated in a starter seminar of the VWB(plus) Ba-Wü. In total, 1,116 teaching units and 160 different seminars covered all relevant topics of the KCA. A restructuring of organisational processes and seminars was necessary to handle the increase in the number of participants, including the development of specific software for electronic support. Of all these seminars, 56% were held by specialists or trainees in family medicine. The participating trainees rated the educational seminars in general and the possibility for networking as (very) good. The contents of the educational seminars included in family medicine training programs will have to be specifically based on family medicine and cover all relevant aspects of the KCA - medical expertise, competencies and procedures. In order to ensure a common standard concerning didactic methods and qualifications of teachers, a didactic guideline is to be developed. The increasing demand of family medicine training programmes requires (further) development of the software eSchoolab, including integration of the KCA. Copyright © 2016. Published by Elsevier GmbH.

Loop-Mediated Isothermal Amplification (LAMP): Emergence As an Alternative Technology for Herbal Medicine Identification.

PubMed

Li, Jing-Jian; Xiong, Chao; Liu, Yue; Liang, Jun-Song; Zhou, Xing-Wen

2016-01-01

Correct identification of medicinal plant ingredients is essential for their safe use and for the regulation of herbal drug supply chain. Loop-mediated isothermal amplification (LAMP) is a recently developed approach to identify herbal medicine species. This novel molecular biology technique enables timely and accurate testing, especially in settings where infrastructures to support polymerase chain reaction facilities are lacking. Studies that used this method have altered our view on the extent and complexity of herbal medicine identification. In this review, we give an introduction into LAMP analysis, covers the basic principles and important aspects in the development of LAMP analysis method. Then we presented a critical review of the application of LAMP-based methods in detecting and identifying raw medicinal plant materials and their processed products. We also provide a practical standard operating procedure (SOP) for the utilization of the LAMP protocol in herbal authentication, and consider the prospects of LAMP technology in the future developments of herbal medicine identification and the challenges associated with its application.

Loop-Mediated Isothermal Amplification (LAMP): Emergence As an Alternative Technology for Herbal Medicine Identification

PubMed Central

Li, Jing-jian; Xiong, Chao; Liu, Yue; Liang, Jun-song; Zhou, Xing-wen

2016-01-01

Correct identification of medicinal plant ingredients is essential for their safe use and for the regulation of herbal drug supply chain. Loop-mediated isothermal amplification (LAMP) is a recently developed approach to identify herbal medicine species. This novel molecular biology technique enables timely and accurate testing, especially in settings where infrastructures to support polymerase chain reaction facilities are lacking. Studies that used this method have altered our view on the extent and complexity of herbal medicine identification. In this review, we give an introduction into LAMP analysis, covers the basic principles and important aspects in the development of LAMP analysis method. Then we presented a critical review of the application of LAMP-based methods in detecting and identifying raw medicinal plant materials and their processed products. We also provide a practical standard operating procedure (SOP) for the utilization of the LAMP protocol in herbal authentication, and consider the prospects of LAMP technology in the future developments of herbal medicine identification and the challenges associated with its application. PMID:28082999

Development and Validation of a Measurement Scale to Analyze the Environment for Evidence-Based Medicine Learning and Practice by Medical Residents

ERIC Educational Resources Information Center

Mi, Fangqiong

2010-01-01

A growing number of residency programs are instituting curricula to include the component of evidence-based medicine (EBM) principles and process. However, these curricula may not be able to achieve the optimal learning outcomes, perhaps because various contextual factors are often overlooked when EBM training is being designed, developed, and…

Family medicine training in sub-Saharan Africa: South-South cooperation in the Primafamed project as strategy for development.

PubMed

Flinkenflögel, Maaike; Essuman, Akye; Chege, Patrick; Ayankogbe, Olayinka; De Maeseneer, Jan

2014-08-01

Health-care systems based on primary health care (PHC) are more equitable and cost effective. Family medicine trains medical doctors in comprehensive PHC with knowledge and skills that are needed to increase quality of care. Family medicine is a relatively new specialty in sub-Saharan Africa. To explore the extent to which the Primafamed South-South cooperative project contributed to the development of family medicine in sub-Saharan Africa. The Primafamed (Primary Health Care and Family Medicine Education) project worked together with 10 partner universities in sub-Saharan Africa to develop family medicine training programmes over a period of 2.5 years. A SWOT (strengths, weaknesses, opportunities and threats) analysis was done and the training development from 2008 to 2010 in the different partner universities was analysed. During the 2.5 years of the Primafamed project, all partner universities made progress in the development of their family medicine training programmes. The SWOT analysis showed that at both national and international levels, the time is ripe to train medical doctors in family medicine and to integrate the specialty into health-care systems, although many barriers, including little awareness, lack of funding, low support from other specialists and reserved support from policymakers, are still present. Family medicine can play an important role in health-care systems in sub-Saharan Africa; however, developing a new discipline is challenging. Advocacy, local ownership, action research and support from governments are necessary to develop family medicine and increase its impact. The Primafamed project showed that development of sustainable family medicine training programmes is a feasible but slow process. The South-South cooperation between the ten partners and the South African departments of family medicine strengthened confidence at both national and international levels. © The Author 2014. Published by Oxford University Press.

Integrating Information Literacy and Evidence-Based Medicine Content within a New School of Medicine Curriculum: Process and Outcome.

PubMed

Muellenbach, Joanne M; Houk, Kathryn M; E Thimons, Dana; Rodriguez, Bredny

2018-01-01

This column describes a process for integrating information literacy (IL) and evidence-based medicine (EBM) content within a new school of medicine curriculum. The project was a collaborative effort among health sciences librarians, curriculum deans, directors, and faculty. The health sciences librarians became members of the curriculum committees, developed a successful proposal for IL and EBM content within the curriculum, and were invited to become course instructors for Analytics in Medicine. As course instructors, the librarians worked with the other faculty instructors to design and deliver active learning class sessions based on a flipped classroom approach using a proprietary Information Mastery curriculum. Results of this collaboration may add to the knowledge base of attitudes and skills needed to practice as full faculty partners in curricular design and instruction.

Manufacturing, characterization and control of cell-based medicinal products: challenging paradigms toward commercial use.

PubMed

Salmikangas, Paula; Menezes-Ferreira, Margarida; Reischl, Ilona; Tsiftsoglou, Asterios; Kyselovic, Jan; Borg, John Joseph; Ruiz, Sol; Flory, Egbert; Trouvin, Jean-Hugues; Celis, Patrick; Ancans, Janis; Timon, Marcos; Pante, Guido; Sladowski, Dariusz; Lipnik-Stangelj, Metoda; Schneider, Christian K

2015-01-01

During the past decade, a large number of cell-based medicinal products have been tested in clinical trials for the treatment of various diseases and tissue defects. However, licensed products and those approaching marketing authorization are still few. One major area of challenge is the manufacturing and quality development of these complex products, for which significant manipulation of cells might be required. While the paradigms of quality, safety and efficacy must apply also to these innovative products, their demonstration may be demanding. Demonstration of comparability between production processes and batches may be difficult for cell-based medicinal products. Thus, the development should be built around a well-controlled manufacturing process and a qualified product to guarantee reproducible data from nonclinical and clinical studies.

[Comparative research into the process of forming the theory of constitution in ancient western medicine and that of four trigrams constitution in Korean medicine and contents of two theories of constitution].

PubMed

Park, Joo-Hong

2009-06-01

After conducting comparative research into the process of forming the Theory of Constitution in Ancient Western Medicine and that of Four Trigrams Constitution(Sasang Constitution) in Korean Medicine and contents of two Theories of Constitution in terms of medical history, both theories were found to be formed by an interaction between philosophy and medicine, followed by a combination of the two, on a philosophical basis. The Theory of Constitution in Ancient Western Medicine began with the Theory of Four Elements presented by Empedocles, followed by the Theory of Four Humors presented by Hippocrates and the Theory of Four Temperaments by Galenos, forming and developing the Theory of Constitution. After the Middle Ages, there was no significant advance in the Theory of Constitution by modern times ; however, it developed into the theory of constitution type of Kretschmer and others after the 19th century and into the scientific theory of constitution based on genetics presented by Garrod and others early in the 20th century. The Theory of Four Trigrams Constitution began with the Theory of Constitution in Huangdi Neijing, followed by developments and influences of existing medicine called beginning, restoration, and revival periods and DongeuisoosebowonSaSangChoBonGwon based on the original philosophy of Four Trigrams presented by Lee Je-ma, which is found in GyeokChiGo, DongMuYuGo and so on, ultimately forming and developing into the Theory of Four Trigrams Constitution in Dongeuisoosebowon. Recently, a lot of research is being conducted into making it objective in order to achieve reproducibility in diagnosis and so forth of Four Trigrams Constitution.

Major achievements of evidence-based traditional Chinese medicine in treating major diseases.

PubMed

Chao, Jung; Dai, Yuntao; Verpoorte, Robert; Lam, Wing; Cheng, Yung-Chi; Pao, Li-Heng; Zhang, Wei; Chen, Shilin

2017-09-01

A long history of use and extensive documentation of the clinical practices of traditional Chinese medicine resulted in a considerable number of classical preparations, which are still widely used. This heritage of our ancestors provides a unique resource for drug discovery. Already, a number of important drugs have been developed from traditional medicines, which in fact form the core of Western pharmacotherapy. Therefore, this article discusses the differences in drug development between traditional medicine and Western medicine. Moreover, the article uses the discovery of artemisinin as an example that illustrates the "bedside-bench-bedside" approach to drug discovery to explain that the middle way for drug development is to take advantage of the best features of these two distinct systems and compensate for certain weaknesses in each. This article also summarizes evidence-based traditional medicines and discusses quality control and quality assessment, the crucial steps in botanical drug development. Herbgenomics may provide effective tools to clarify the molecular mechanism of traditional medicines in the botanical drug development. The totality-of-the-evidence approach used by the U.S. Food and Drug Administration for botanical products provides the directions on how to perform quality control from the field throughout the entire production process. Copyright © 2017 Elsevier Inc. All rights reserved.

[Recombinant granulocyte-colony stimulating factor (filgrastim): optimization of conditions of isolation and purification from inclusion body].

PubMed

Kononova, N V; Iakovlev, A V; Zhuravko, A M; Pankeev, N N; Minaev, S V; Bobruskin, A I; Mart'ianov, V A

2014-01-01

We developed a unified process platform for two recombinant human GCSF medicines--one with the non-prolonged and the other with prolonged action. This unified technology led to a simpler and cheaper production while introduction of the additional pegylation stage to the technological line eased obtaining of the medicines with different action and allowed to standardize technological process documenting according to GMP requirements.

[Discussion on efficacy evaluation thought and method for innovation medicine of Chinese herbal compound formula based on clinical application characteristics].

PubMed

Sun, Jian-Ning; Sun, Wen-Yan; Dong, Shi-Fen

2017-03-01

The Chinese herbal compound formula preparation was made based on theory of Chinese medicine, which was confirmed by long period clinical application, and with multi-compound and multi-target characteristics. During the exploitation process of innovation medicine of Chinese herbal compound formula, selecting and speeding up the research development of drugs with clinical value shall be paid more attention, and as request of rules involved in new drug research and development, the whole process management should be carried out, including project evaluation, manufacturing process determination, establishment of quality control standards, evaluation for pharmacological and toxic effect, as well as new drug application process. This reviews was aimed to give some proposals for pharmacodynamics research methods involved in exploration of Chinese herbal compound formula preparation, including： ①the endpoint criteria should meet the clinical attribution of new drugs; ②the pre-clinical pharmacodynamics evaluation should be carried on appropriate animal models according to the characteristics of diagnosis and therapy of Chinese medicine and observation indexes; ③during the innovation of drug for infants and children, information on drug action conforming to physiological characteristics of infants and children should be supplied, and the pharmacodynamics and toxicology research shall be conducted in immature rats according to the body weight of children. In a summary, the clinical application characteristics are the important criteria for evaluation of pharmacological effect of innovation medicine of Chinese herbal compound formula. Copyright© by the Chinese Pharmaceutical Association.

The Internal Medicine of the 21st century: Organizational and operational standards.

PubMed

Casariego-Vales, E; Zapatero-Gaviria, A; Elola-Somoza, F J

2017-12-01

The Spanish Society of Internal Medicine has developed a consensus document on the standards and recommendations that they consider essential to the organisation of internal medicine units for conducting their activities efficiently and with high quality. We defined 3 groups of key processes: the care of acutely ill adult patients, the comprehensive care of complex chronic patients and the examination of a patient with a difficult diagnosis and no organ-specific disease. As support processes, we identified the structure and operation of the Internal Medicine units. As strategic processes, we identified training and research. The main subprocesses are structured below, and we established the standards and recommendations for each of them. Lastly, we proposed resulting workloads. The prepared standards must be reviewed within a maximum of 4 years. Copyright © 2017 Elsevier España, S.L.U. and Sociedad Española de Medicina Interna (SEMI). All rights reserved.

National medicines policies – a review of the evolution and development processes

PubMed Central

2013-01-01

Objectives Continuous provision of appropriate medicines of assured quality, in adequate quantities, and at reasonable prices is a concern for all national governments. A national medicines policy (NMP) developed in a collaborative fashion identifies strategies needed to meet these objectives and provides a comprehensive framework to develop all components of a national pharmaceutical sector. To meet the health needs of the population, there is a general need for medicine policies based on universal principles, but nevertheless adapted to the national situation. This review aims to provide a quantitative and qualitative (describing the historical development) study of the development process and evolution of NMPs. Methods The number of NMPs and their current status has been obtained from the results of the assessment of WHO Level I indicators. The policy formulation process is examined in more detail with case studies from four countries: Sri Lanka, Australia, former Yugoslav Republic of Macedonia and South Africa. Results The number of NMPs worldwide has increased in the last 25 years with the highest proportional increase in the last 5–10 years in high-income countries. Higher income countries seem to have more NMP implementation plans available and have updated their NMP more recently. The four case studies show that the development of a NMP is a complex process that is country specific. In addition, it demonstrates that an appropriate political window is needed for the policy to be passed (for South Africa and the FYR Macedonia, a major political event acted as a trigger for initiating the policy development). Policy-making does not stop with the official adoption of a policy but should create mechanisms for implementation and monitoring. The NMPs of the FYR Macedonia and Australia provide indicators for monitoring. Conclusions To date, not all countries have a NMP since political pressure by national experts or non-governmental organizations is generally needed to establish a NMP. Case studies in four countries showed that the policy process is just as important as the policy document since the process must create a mechanism by which all stakeholders are brought together and a sense of collective ownership of the final policy may be achieved. PMID:24764540

An analysis of application of health informatics in Traditional Medicine: A review of four Traditional Medicine Systems.

PubMed

Raja Ikram, Raja Rina; Abd Ghani, Mohd Khanapi; Abdullah, Noraswaliza

2015-11-01

This paper shall first investigate the informatics areas and applications of the four Traditional Medicine systems - Traditional Chinese Medicine (TCM), Ayurveda, Traditional Arabic and Islamic Medicine and Traditional Malay Medicine. Then, this paper shall examine the national informatics infrastructure initiatives in the four respective countries that support the Traditional Medicine systems. Challenges of implementing informatics in Traditional Medicine Systems shall also be discussed. The literature was sourced from four databases: Ebsco Host, IEEE Explore, Proquest and Google scholar. The search term used was "Traditional Medicine", "informatics", "informatics infrastructure", "traditional Chinese medicine", "Ayurveda", "traditional Arabic and Islamic medicine", and "traditional malay medicine". A combination of the search terms above was also executed to enhance the searching process. A search was also conducted in Google to identify miscellaneous books, publications, and organization websites using the same terms. Amongst major advancements in TCM and Ayurveda are bioinformatics, development of Traditional Medicine databases for decision system support, data mining and image processing. Traditional Chinese Medicine differentiates itself from other Traditional Medicine systems with documented ISO Standards to support the standardization of TCM. Informatics applications in Traditional Arabic and Islamic Medicine are mostly ehealth applications that focus more on spiritual healing, Islamic obligations and prophetic traditions. Literature regarding development of health informatics to support Traditional Malay Medicine is still insufficient. Major informatics infrastructure that is common in China and India are automated insurance payment systems for Traditional Medicine treatment. National informatics infrastructure in Middle East and Malaysia mainly cater for modern medicine. Other infrastructure such as telemedicine and hospital information systems focus its implementation in modern medicine or are not implemented and strategized at a national level to support Traditional Medicine. Informatics may not be able to address all the emerging areas of Traditional Medicine because the concepts in Traditional Medicine system of medicine are different from modern system, though the aim may be same, i.e., to give relief to the patient. Thus, there is a need to synthesize Traditional Medicine systems and informatics with involvements from modern system of medicine. Future research works may include filling the gaps of informatics areas and integrate national informatics infrastructure with established Traditional Medicine systems. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

Development of the adult and child complementary medicine questionnaires fielded on the National Health Interview Survey

PubMed Central

2013-01-01

The 2002, 2007, and 2012 complementary medicine questionnaires fielded on the National Health Interview Survey provide the most comprehensive data on complementary medicine available for the United States. They filled the void for large-scale, nationally representative, publicly available datasets on the out-of-pocket costs, prevalence, and reasons for use of complementary medicine in the U.S. Despite their wide use, this is the first article describing the multi-faceted and largely qualitative processes undertaken to develop the surveys. We hope this in-depth description enables policy makers and researchers to better judge the content validity and utility of the questionnaires and their resultant publications. PMID:24267412

Development of the adult and child complementary medicine questionnaires fielded on the National Health Interview Survey.

PubMed

Stussman, Barbara J; Bethell, Christina D; Gray, Caroline; Nahin, Richard L

2013-11-23

The 2002, 2007, and 2012 complementary medicine questionnaires fielded on the National Health Interview Survey provide the most comprehensive data on complementary medicine available for the United States. They filled the void for large-scale, nationally representative, publicly available datasets on the out-of-pocket costs, prevalence, and reasons for use of complementary medicine in the U.S. Despite their wide use, this is the first article describing the multi-faceted and largely qualitative processes undertaken to develop the surveys. We hope this in-depth description enables policy makers and researchers to better judge the content validity and utility of the questionnaires and their resultant publications.

The Significance of an Enhanced Concept of the Organism for Medicine

PubMed Central

2016-01-01

Recent developments in evolutionary biology, comparative embryology, and systems biology suggest the necessity of a conceptual shift in the way we think about organisms. It is becoming increasingly evident that molecular and genetic processes are subject to extremely refined regulation and control by the cell and the organism, so that it becomes hard to define single molecular functions or certain genes as primary causes of specific processes. Rather, the molecular level is integrated into highly regulated networks within the respective systems. This has consequences for medical research in general, especially for the basic concept of personalized medicine or precision medicine. Here an integrative systems concept is proposed that describes the organism as a multilevel, highly flexible, adaptable, and, in this sense, autonomous basis for a human individual. The hypothesis is developed that these properties of the organism, gained from scientific observation, will gradually make it necessary to rethink the conceptual framework of physiology and pathophysiology in medicine. PMID:27446221

EMEA and Gene Therapy Medicinal Products Development in the European Union

PubMed Central

2003-01-01

The evaluation of quality, safety, and efficacy of medicinal products by the European Medicines Evaluation Agency (EMEA) via the centralized procedure is the only available regulatory procedure for obtaining marketing authorization for gene therapy (GT) medicinal products in the European Union. The responsibility for the authorization of clinical trials remains with the national competent authorities (NCA) acting in a harmonized framework from the scientific viewpoint. With the entry into force of a new directive on good clinical practice implementation in clinical trials as of 1 May 2004, procedural aspects will also be harmonized at EU level. Scientifically sound development of medicinal products is the key for the successful registration of dossiers and for contributing to the promotion and protection of public health. The objective of this paper is to introduce the EMEA regulatory processes and scientific activities relevant to GT medicinal products. PMID:12686717

Using Lean Management to Reduce Emergency Department Length of Stay for Medicine Admissions.

PubMed

Allaudeen, Nazima; Vashi, Anita; Breckenridge, Julia S; Haji-Sheikhi, Farnoosh; Wagner, Sarah; Posley, Keith A; Asch, Steven M

The practice of boarding admitted patients in the emergency department (ED) carries negative operational, clinical, and patient satisfaction consequences. Lean tools have been used to improve ED workflow. Interventions focused on reducing ED length of stay (LOS) for admitted patients are less explored. To evaluate a Lean-based initiative to reduce ED LOS for medicine admissions. Prospective quality improvement initiative performed at a single university-affiliated Department of Veterans Affairs (VA) medical center from February 2013 to February 2016. We performed a Lean-based multidisciplinary initiative beginning with a rapid process improvement workshop to evaluate current processes, identify root causes of delays, and develop countermeasures. Frontline staff developed standard work for each phase of the ED stay. Units developed a daily management system to reinforce, evaluate, and refine standard work. The primary outcome was the change in ED LOS for medicine admissions pre- and postintervention. ED LOS at the intervention site was compared with other similar VA facilities as controls over the same time period using a difference-in-differences approach. ED LOS for medicine admissions reduced 26.4%, from 8.7 to 6.4 hours. Difference-in-differences analysis showed that ED LOS for combined medicine and surgical admissions decreased from 6.7 to 6.0 hours (-0.7 hours, P = .003) at the intervention site compared with no change (5.6 hours, P = .2) at the control sites. We utilized Lean management to significantly reduce ED LOS for medicine admissions. Specifically, the development and management of standard work were key to sustaining these results.

Rethinking health sector procurement as developmental linkages in East Africa.

PubMed

Mackintosh, Maureen; Tibandebage, Paula; Karimi Njeru, Mercy; Kariuki Kungu, Joan; Israel, Caroline; Mujinja, Phares G M

2018-03-01

Health care forms a large economic sector in all countries, and procurement of medicines and other essential commodities necessarily creates economic linkages between a country's health sector and local and international industrial development. These procurement processes may be positive or negative in their effects on populations' access to appropriate treatment and on local industrial development, yet procurement in low and middle income countries (LMICs) remains under-studied: generally analysed, when addressed at all, as a public sector technical and organisational challenge rather than a social and economic element of health system governance shaping its links to the wider economy. This article uses fieldwork in Tanzania and Kenya in 2012-15 to analyse procurement of essential medicines and supplies as a governance process for the health system and its industrial links, drawing on aspects of global value chain theory. We describe procurement work processes as experienced by front line staff in public, faith-based and private sectors, linking these experiences to wholesale funding sources and purchasing practices, and examining their implications for medicines access and for local industrial development within these East African countries. We show that in a context of poor access to reliable medicines, extensive reliance on private medicines purchase, and increasing globalisation of procurement systems, domestic linkages between health and industrial sectors have been weakened, especially in Tanzania. We argue in consequence for a more developmental perspective on health sector procurement design, including closer policy attention to strengthening vertical and horizontal relational working within local health-industry value chains, in the interests of both wider access to treatment and improved industrial development in Africa. Copyright © 2018 The Authors. Published by Elsevier Ltd.. All rights reserved.

Necessary conditions for the globalization of traditional Chinese medicine.

PubMed

Yu, Bei-Bei; Gong, Xiu-Lin

2011-03-01

With the current trend of globalization, unprecedented opportunities and enormous changes have emerged for the global development of traditional Chinese medicine (TCM). However, many old and new challenges and problems still remain, including partial or limited comprehension of acupuncture, oriental medicine and TCM, the existence of non-standardized institutes of TCM and acupuncture training schools, unqualified TCM practitioners, and problems concerning Chinese herbal medicine and inexperience in conducting TCM business. These problems will doubtlessly impede the further development of TCM worldwide in the foreseeable future. It is also clear that the globalization of TCM will require a large scale systematic project and constitute an arduous historical task. This paper aims to consolidate 6 strategic development modes to reinforce and facilitate the process of TCM globalization through a detailed analysis of both the present status and existing problems concerning the development of TCM in the United States.

Quest for quality: department of laboratory medicine and pathology, Mayo Clinic.

PubMed

Arney, Kris R; Hopper, Mary H; Tran, Sheryl A; Ward, Melissa M; Hanson, Curtis A

2004-01-01

This article describes our journey for quality in the Department of Laboratory Medicine and Pathology (DLMP) at Mayo Clinic. It provides the background of the department and the process for the development and implementation of the quality program. In addition, a quality conference and the development of a quality school are outlined. Throughout the course of this process, valuable lessons were learned and are discussed. We are pleased with the success of the quality journey. However, we realize that the quest has just begun. We look forward to the future and the challenges that lie ahead.

Non-prescription medicines: a process for standards development and testing in community pharmacy.

PubMed

Benrimoj, Shalom Charlie I; Gilbert, Andrew; Quintrell, Neil; Neto, Abilio C de Almeida

2007-08-01

The objective of the study was to develop and test standards of practice for handling non-prescription medicines. In consultation with pharmacy registering authorities, key professional and consumer groups and selected community pharmacists, standards of practice were developed in the areas of Resource Management; Professional Practice; Pharmacy Design and Environment; and Rights and Needs of Customers. These standards defined and described minimum professional activities required in the provision of non-prescription medicines at a consistent and measurable level of practice. Seven standards were described and further defined by 20 criteria, including practice indicators. The Standards were tested in 40 community pharmacies in two States and after further adaptation, endorsed by all Australian pharmacy registering authorities and major Australian pharmacy and consumer organisations. The consultation process effectively engaged practicing pharmacists in developing standards to enable community pharmacists meet their legislative and professional responsibilities. Community pharmacies were audited against a set of standards of practice for handling non-prescription medicines developed in this project. Pharmacies were audited on the Standards at baseline, mid-intervention and post-intervention. Behavior of community pharmacists and their staff in relation to these standards was measured by conducting pseudo-patron visits to participating pharmacies. The testing process demonstrated a significant improvement in the quality of service delivered by staff in community pharmacies in the management of requests involving non-prescription medicines. The use of pseudo-patron visits, as a training tool with immediate feedback, was an acceptable and effective method of achieving changes in practice. Feedback from staff in the pharmacies regarding the pseudo-patron visits was very positive. Results demonstrated the methodology employed was effective in increasing overall compliance with the Standards from a rate of 47.4% to 70.0% (P < 0.01). This project led to a recommendation for the development and execution of a national implementation strategy.

Postharvest Processing and Benefits of Black Pepper, Coriander, Cinnamon, Fenugreek, and Turmeric Spices.

PubMed

Balasubramanian, S; Roselin, P; Singh, K K; Zachariah, John; Saxena, S N

2016-07-26

Spices are prime source for flavor, aroma, and taste in cuisines and play an active role as medicines due to their high antioxidant properties. As medicine or food, the importance of spices cannot be overemphasized. The medicinal values of spices are very well established in treating various ailments like cancer, fever, malaria, stomach offset, nausea, and many more. A spice may be available in several forms: fresh, whole dried, or pre-ground dried which requires further processing to be utilized in the form of value-added product. This review paper deals with the cultivation, postharvesting, chemical composition, uses, health, and medicinal benefits of the selected spice viz., black pepper, coriander, cinnamon, fenugreek, turmeric, and technological advances in processing of spices viz., super critical fluid extraction, cryogenic grinding, and microencapsulation etc. This paper also focuses on issues related to utilization of spices toward its high end-product development and characterization in pharmaceuticals and other medicinal purposes. The availability of different spices and their varietal differences and location have their pertinent characters, which are much demanding to refine postharvest and processing to assure its quality in the international market.

Evidence synthesis and guideline development in genomic medicine: current status and future prospects.

PubMed

Schully, Sheri D; Lam, Tram Kim; Dotson, W David; Chang, Christine Q; Aronson, Naomi; Birkeland, Marian L; Brewster, Stephanie Jo; Boccia, Stefania; Buchanan, Adam H; Calonge, Ned; Calzone, Kathleen; Djulbegovic, Benjamin; Goddard, Katrina A B; Klein, Roger D; Klein, Teri E; Lau, Joseph; Long, Rochelle; Lyman, Gary H; Morgan, Rebecca L; Palmer, Christina G S; Relling, Mary V; Rubinstein, Wendy S; Swen, Jesse J; Terry, Sharon F; Williams, Marc S; Khoury, Muin J

2015-01-01

With the accelerated implementation of genomic medicine, health-care providers will depend heavily on professional guidelines and recommendations. Because genomics affects many diseases across the life span, no single professional group covers the entirety of this rapidly developing field. To pursue a discussion of the minimal elements needed to develop evidence-based guidelines in genomics, the Centers for Disease Control and Prevention and the National Cancer Institute jointly held a workshop to engage representatives from 35 organizations with interest in genomics (13 of which make recommendations). The workshop explored methods used in evidence synthesis and guideline development and initiated a dialogue to compare these methods and to assess whether they are consistent with the Institute of Medicine report "Clinical Practice Guidelines We Can Trust." The participating organizations that develop guidelines or recommendations all had policies to manage guideline development and group membership, and processes to address conflicts of interests. However, there was wide variation in the reliance on external reviews, regular updating of recommendations, and use of systematic reviews to assess the strength of scientific evidence. Ongoing efforts are required to establish criteria for guideline development in genomic medicine as proposed by the Institute of Medicine.

27 CFR 21.34 - Formula No. 2-C.

Code of Federal Regulations, 2010 CFR

2010-04-01

... gallon of rubber hydrocarbon solvent. (b) Authorized uses. (1) As a solvent: 344.Processing medicinal....Drugs and medicinal chemicals. 579.Other chemicals. (3) Miscellaneous uses: 812.Product development and pilot plant uses (own use only). (c) Conditions governing use. This formula shall be used in a closed...

27 CFR 21.34 - Formula No. 2-C.

Code of Federal Regulations, 2011 CFR

2011-04-01

... gallon of rubber hydrocarbon solvent. (b) Authorized uses. (1) As a solvent: 344.Processing medicinal....Drugs and medicinal chemicals. 579.Other chemicals. (3) Miscellaneous uses: 812.Product development and pilot plant uses (own use only). (c) Conditions governing use. This formula shall be used in a closed...

[Hope for patients with rare diseases--"orphan" drugs].

PubMed

Kuzelová, M; Kubácková, K; Palágyi, M; Smíd, M

2006-01-01

Rare diseases are defined as those affected less than five in every 10 000 person in European Union. The purpose of this paper is to present activities, which make possible to stimulate research development and marketing of appropriate medicine for tretment of rare disease, named "Orphan" medicinal products. EU "Orphan" medicinal products legislation which entered into force in April 2000 is described. Definition of "Orphan" medicinal products as well as the procedure of designation and placing the products into the Community register is presented. Those incentives to industry are described, which are already five years very well implemented oh the European level mostly on the pre-authorisation phase of "Orphan" medicinal products development, but also in the registration process as well as the post-authorisation phase. Finaly, the first twenty "Orphan" medicinal products, which have been given positive opinion in the Community for the grant of a marketing authorisation till April 2005 are mentioned in this work. The real availability of "Orphan" medicinal products in the particular EU member states is analysed.

DNA based identification of medicinal materials in Chinese patent medicines

NASA Astrophysics Data System (ADS)

Chen, Rong; Dong, Juan; Cui, Xin; Wang, Wei; Yasmeen, Afshan; Deng, Yun; Zeng, Xiaomao; Tang, Zhuo

2012-12-01

Chinese patent medicines (CPM) are highly processed and easy to use Traditional Chinese Medicine (TCM). The market for CPM in China alone is tens of billions US dollars annually and some of the CPM are also used as dietary supplements for health augmentation in the western countries. But concerns continue to be raised about the legality, safety and efficacy of many popular CPM. Here we report a pioneer work of applying molecular biotechnology to the identification of CPM, particularly well refined oral liquids and injections. What's more, this PCR based method can also be developed to an easy to use and cost-effective visual chip by taking advantage of G-quadruplex based Hybridization Chain Reaction. This study demonstrates that DNA identification of specific Medicinal materials is an efficient and cost-effective way to audit highly processed CPM and will assist in monitoring their quality and legality.

[The implementation of strategy of medicinal support in multi-type hospital].

PubMed

Ludupova, E Yu

2016-01-01

The article presents brief review of implementation of strategy of medicinal support of population of the Russian Federation and experience of application of at the level of regional hospital. The necessity and importance of implementation into practice of hospitals of methodology of pharmaco-economical management of medicinal care using modern technologies of XYZ-, ABC and VEN-analysis is demonstrated. The stages of development and implementation of process of medicinal support of multifield hospital applying principles of system of quality management (processing and systemic approaches, risk management) on the basis of standards ISO 9001 are described. The significance of monitoring of results ofprocess of medicinal support of the basis of implementation of priority target programs (prevention of venous thrombo-embolic complications, system od control of anti-bacterial therapy) are demonstrated in relation to multi-field hospital using technique of ATC/DDD-analysis for evaluating indices of effectiveness and efficiency.

Core competencies for pharmaceutical physicians and drug development scientists

PubMed Central

Silva, Honorio; Stonier, Peter; Buhler, Fritz; Deslypere, Jean-Paul; Criscuolo, Domenico; Nell, Gerfried; Massud, Joao; Geary, Stewart; Schenk, Johanna; Kerpel-Fronius, Sandor; Koski, Greg; Clemens, Norbert; Klingmann, Ingrid; Kesselring, Gustavo; van Olden, Rudolf; Dubois, Dominique

2013-01-01

Professional groups, such as IFAPP (International Federation of Pharmaceutical Physicians and Pharmaceutical Medicine), are expected to produce the defined core competencies to orient the discipline and the academic programs for the development of future competent professionals and to advance the profession. On the other hand, PharmaTrain, an Innovative Medicines Initiative project, has become the largest public-private partnership in biomedicine in the European Continent and aims to provide postgraduate courses that are designed to meet the needs of professionals working in medicines development. A working group was formed within IFAPP including representatives from PharmaTrain, academic institutions and national member associations, with special interest and experience on Quality Improvement through education. The objectives were: to define a set of core competencies for pharmaceutical physicians and drug development scientists, to be summarized in a Statement of Competence and to benchmark and align these identified core competencies with the Learning Outcomes (LO) of the PharmaTrain Base Course. The objectives were successfully achieved. Seven domains and 60 core competencies were identified and aligned accordingly. The effective implementation of training programs using the competencies or the PharmaTrain LO anywhere in the world may transform the drug development process to an efficient and integrated process for better and safer medicines. The PharmaTrain Base Course might provide the cognitive framework to achieve the desired Statement of Competence for Pharmaceutical Physicians and Drug Development Scientists worldwide. PMID:23986704

Translational Medicine Guide transforms drug development processes: the recent Merck experience.

PubMed

Dolgos, Hugues; Trusheim, Mark; Gross, Dietmar; Halle, Joern-Peter; Ogden, Janet; Osterwalder, Bruno; Sedman, Ewen; Rossetti, Luciano

2016-03-01

Merck is implementing a question-based Translational Medicine Guide (TxM Guide) beginning as early as lead optimization into its stage-gate drug development process. Initial experiences with the TxM Guide, which is embedded into an integrated development plan tailored to each development program, demonstrated opportunities to improve target understanding, dose setting (i.e., therapeutic index), and patient subpopulation selection with more robust and relevant early human-based evidence, and increased use of biomarkers and simulations. The TxM Guide is also helping improve organizational learning, costs, and governance. It has also shown the need for stronger external resources for validating biomarkers, demonstrating clinical utility, tracking natural disease history, and biobanking. Copyright © 2016 The Authors. Published by Elsevier Ltd.. All rights reserved.

Fast analysis of principal volatile compounds in crude and processed Atractylodes macrocephala by an automated static headspace gas chromatography-mass spectrometry

PubMed Central

Zhang, Jida; Cao, Gang; Xia, Yunhua; Wen, Chengping; Fan, Yongsheng

2014-01-01

Objective: Atractylodes macrocephala, a famous herbal medicine, is used extensively in the practice of Traditional Chinese Medicine (TCM). Processing procedure is a common approach that usually occurs before A. macrocephala is prescribed. This paper describes a sensitive and specific assay for the determination of principal volatile compounds in crude and processed A. macrocephala. Materials and Methods: The present study concentrated on the development of a static headspace gas chromatography-mass spectrometry (SHS-GC/MS) for separating and identifying of volatile compounds from crude and processed A. macrocephala samples. Results: The results showed that the volatile oil in crude and processed A. macrocephala was markedly quantitatively and qualitatively different. Processing resulted in the reduction of volatile oil contents and variation of chemical compositions in A. macrocephala. Conclusion: The proposed method proved that SHS-GC/MS is rapid and specific, and should also be useful for evaluating the quality of crude and processed medicinal herbs. PMID:25210311

Failures to further developing orphan medicinal products after designation granted in Europe: an analysis of marketing authorisation failures and abandoned drugs.

PubMed

Giannuzzi, Viviana; Landi, Annalisa; Bosone, Enrico; Giannuzzi, Floriana; Nicotri, Stefano; Torrent-Farnell, Josep; Bonifazi, Fedele; Felisi, Mariagrazia; Bonifazi, Donato; Ceci, Adriana

2017-09-11

The research and development process in the field of rare diseases is characterised by many well-known difficulties, and a large percentage of orphan medicinal products do not reach the marketing approval.This work aims at identifying orphan medicinal products that failed the developmental process and investigating reasons for and possible factors influencing failures. Drugs designated in Europe under Regulation (European Commission) 141/2000 in the period 2000-2012 were investigated in terms of the following failures: (1) marketing authorisation failures (refused or withdrawn) and (2) drugs abandoned by sponsors during development.Possible risk factors for failure were analysed using statistically validated methods. This study points out that 437 out of 788 designations are still under development, while 219 failed the developmental process. Among the latter, 34 failed the marketing authorisation process and 185 were abandoned during the developmental process. In the first group of drugs (marketing authorisation failures), 50% reached phase II, 47% reached phase III and 3% reached phase I, while in the second group (abandoned drugs), the majority of orphan medicinal products apparently never started the development process, since no data on 48.1% of them were published and the 3.2% did not progress beyond the non-clinical stage.The reasons for failures of marketing authorisation were: efficacy/safety issues (26), insufficient data (12), quality issues (7), regulatory issues on trials (4) and commercial reasons (1). The main causes for abandoned drugs were efficacy/safety issues (reported in 54 cases), inactive companies (25.4%), change of company strategy (8.1%) and drug competition (10.8%). No information concerning reasons for failure was available for 23.2% of the analysed products. This analysis shows that failures occurred in 27.8% of all designations granted in Europe, the main reasons being safety and efficacy issues. Moreover, the stage of development reached by drugs represents a specific risk factor for failures. © 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.

The application of tribology in assessing texture perception of oral liquid medicines.

PubMed

Batchelor, Hannah; Venables, Rebecca; Marriott, John; Mills, Tom

2015-02-20

The palatability of medicines is likely to have a significant impact on patient adherence and consequently, on the safety and efficacy of a medicinal product. Palatability encompasses properties of medicines not limited to taste including swallowability (e.g. size, shape, texture). However, there has been limited work undertaken to measure the texture of medicines and how this may affect palatability and subsequent adherence. Tribology offers an understanding of oral processes and can allow physical properties of materials to be linked to "mouthfeel". This paper describes a preliminary application of tribology to oral liquid medicines and demonstrates that this technique is useful in the development of future oral liquid medicines. Copyright © 2015 Elsevier B.V. All rights reserved.

[Pages from the history of the Department of Forensic Medicine, I.M. Sechenov First Moscow State Medical University].

PubMed

Leonova, E N; Romanenko, G Kh; Sidorovich, Iu V

2012-01-01

The history of the Department of Forensic Medicine of I.M. Sechenov First Moscow State Medical University is highlighted based on the results of the studies of the relevant literature data and archival materials. The authors lay special emphasis on the organization of the teaching process and research at different stages of the development of the Department, scientific and forensic medical activities of its leading specialists, materials obtained in the course of research, and the contribution to the development of forensic medicine made by outstanding scientists.

WHO Expert Committee on Specifications for Pharmaceutical Preparations.

PubMed

2012-01-01

The Expert Committee on Specifications for Pharmaceutical Preparations works towards clear, independent and practical standards and guidelines for the quality assurance of medicines. Standards are developed by the Committee through worldwide consultation and an international consensus-building process. The following new guidelines were adopted and recommended for use: Development of monographs for The International Pharmacopoeia; WHO good manufacturing practices: water for pharmaceutical use; Pharmaceutical development of multisource (generic) pharmaceutical products--points to consider; Guidelines on submission of documentation for a multisource (generic) finished pharmaceutical product for the WHO Prequalification of Medicines Programme: quality part; Development of paediatric medicines: points to consider in formulation; Recommendations for quality requirements for artemisinin as a starting material in the production of antimalarial active pharmaceutical ingredients.

Manufacturing Road Map for Tissue Engineering and Regenerative Medicine Technologies

PubMed Central

Hunsberger, Joshua; Harrysson, Ola; Shirwaiker, Rohan; Starly, Binil; Wysk, Richard; Cohen, Paul; Allickson, Julie; Yoo, James

2015-01-01

Summary The Regenerative Medicine Foundation Annual Conference held on May 6 and 7, 2014, had a vision of assisting with translating tissue engineering and regenerative medicine (TERM)-based technologies closer to the clinic. This vision was achieved by assembling leaders in the field to cover critical areas. Some of these critical areas included regulatory pathways for regenerative medicine therapies, strategic partnerships, coordination of resources, developing standards for the field, government support, priorities for industry, biobanking, and new technologies. The final day of this conference featured focused sessions on manufacturing, during which expert speakers were invited from industry, government, and academia. The speakers identified and accessed roadblocks plaguing the field where improvements in advanced manufacturing offered many solutions. The manufacturing sessions included (a) product development toward commercialization in regenerative medicine, (b) process challenges to scale up manufacturing in regenerative medicine, and (c) infrastructure needs for manufacturing in regenerative medicine. Subsequent to this, industry was invited to participate in a survey to further elucidate the challenges to translation and scale-up. This perspective article will cover the lessons learned from these manufacturing sessions and early results from the survey. We also outline a road map for developing the manufacturing infrastructure, resources, standards, capabilities, education, training, and workforce development to realize the promise of TERM. PMID:25575525

Exploring Biomedicalization Through Complementary and Alternative Medicine in a Postsocialist Context.

PubMed

Klepal, Jaroslav; Stöckelová, Tereza

2018-06-20

Drawing on fieldwork in the postsocialist Czech Republic, we explore the transformative processes of biomedicalization, both within and in relation to complementary and alternative medicine (CAM). We argue that it would be simplistic to understand evidence of these processes in CAM as a sign that CAM has fallen prey to biomedicine. Instead, we show how particular CAM practices play a groundbreaking role in shaping developments in contemporary health care. In this respect, we question the utility of the concept of biomedicalization, arguing that it reduces the transformative processes to aspects of biomedicine.

The development of biomarkers to reduce attrition rate in drug discovery focused on oncology and central nervous system.

PubMed

Safavi, Maliheh; Sabourian, Reyhaneh; Abdollahi, Mohammad

2016-10-01

The task of discovery and development of novel therapeutic agents remains an expensive, uncertain, time-consuming, competitive, and inefficient enterprise. Due to a steady increase in the cost and time of drug development and the considerable amount of resources required, a predictive tool is needed for assessing the safety and efficacy of a new chemical entity. This study is focused on the high attrition rate in discovery and development of oncology and central nervous system (CNS) medicines, because the failure rate of these medicines is higher than others. Some approaches valuable in reducing attrition rates are proposed and the judicious use of biomarkers is discussed. Unlike the significant progress made in identifying and characterizing novel mechanisms of disease processes and targeted therapies, the process of novel drug development is associated with an unacceptably high attrition rate. The application of clinically qualified predictive biomarkers holds great promise for further development of therapeutic targets, improved survival, and ultimately personalized medicine sets for patients. Decisions such as candidate selection, development risks, dose ranging, early proof of concept/principle, and patient stratification are based on the measurements of biologically and/or clinically validated biomarkers.

Family medicine education in Canada, 1983.

PubMed

Hennen, B K

1983-12-01

We now have good information about family medicine in terms of content, principles, and practice load. Undergraduate, residency and continuing education are improving, but some family medicine programs still have limited support from their university's faculty and governments. Residency in-training assessment and the certification process are better developed than is evaluation of new family doctors' practice performance. Research in the family medicine base is expanding, and residents are increasingly involved in projects. Family medicine teachers are now on a par with other clinical faculty, because they must meet tougher criteria for appointment and promotion. The political leadership of family medicine education, shared by the College of Family Physicians of Canada and academic departments, requires strong consensus and persistent activity.

Framing access to medicines in developing countries: an analysis of media coverage of Canada's Access to Medicines Regime

PubMed Central

2010-01-01

Background In September 2003, the Canadian government committed to developing legislation that would facilitate greater access to affordable medicines for developing countries. Over the course of eight months, the legislation, now known as Canada's Access to Medicines Regime (CAMR), went through a controversial policy development process and the newspaper media was one of the major venues in which the policy debates took place. The purpose of this study was to examine how the media framed CAMR to determine how policy goals were conceptualized, which stakeholder interests controlled the public debate and how these variables related to the public policy process. Methods We conducted a qualitative content analysis of newspaper coverage of the CAMR policy and implementation process from 2003-2008. The primary theoretical framework for this study was framing theory. A total of 90 articles from 11 Canadian newspapers were selected for inclusion in our analysis. A team of four researchers coded the articles for themes relating to access to medicines and which stakeholders' voice figured more prominently on each issue. Stakeholders examined included: the research-based industry, the generic industry, civil society, the Canadian government, and developing country representatives. Results The most frequently mentioned themes across all documents were the issues of drug affordability, intellectual property, trade agreements and obligations, and development. Issues such as human rights, pharmaceutical innovation, and economic competitiveness got little media representation. Civil society dominated the media contents, followed far behind by the Canadian government, the research-based and generic pharmaceutical industries. Developing country representatives were hardly represented in the media. Conclusions Media framing obscured the discussion of some of the underlying policy goals in this case and failed to highlight issues which are now significant barriers to the use of the legislation. Using the media to engage the public in more in-depth exploration of the policy issues at stake may contribute to a more informed policy development process. The media can be an effective channel for those stakeholders with a weaker voice in policy deliberations to raise public attention to particular issues; however, the political and institutional context must be taken into account as it may outweigh media framing effects. PMID:20044940

Insect natural products and processes: new treatments for human disease.

PubMed

Ratcliffe, Norman A; Mello, Cicero B; Garcia, Eloi S; Butt, Tariq M; Azambuja, Patricia

2011-10-01

In this overview, some of the more significant recent developments in bioengineering natural products from insects with use or potential use in modern medicine are described, as well as in utilisation of insects as models for studying essential mammalian processes such as immune responses to pathogens. To date, insects have been relatively neglected as sources of modern drugs although they have provided valuable natural products, including honey and silk, for at least 4-7000 years, and have featured in folklore medicine for thousands of years. Particular examples of Insect Folk Medicines will briefly be described which have subsequently led through the application of molecular and bioengineering techniques to the development of bioactive compounds with great potential as pharmaceuticals in modern medicine. Insect products reviewed have been derived from honey, venom, silk, cantharidin, whole insect extracts, maggots, and blood-sucking arthropods. Drug activities detected include powerful antimicrobials against antibiotic-resistant bacteria and HIV, as well as anti-cancer, anti-angiogenesis and anti-coagulant factors and wound healing agents. Finally, the many problems in developing these insect products as human therapeutic drugs are considered and the possible solutions emerging to these problems are described. Copyright © 2011 Elsevier Ltd. All rights reserved.

Use of WONCA global standards to evaluate family medicine postgraduate education for curriculum development and review in Nepal and Myanmar.

PubMed

Gibson, Christine; Ladak, Farah; Shrestha, Ashis; Yadav, Bharat; Thu, Kyaw; Aye, Tin

2016-09-01

Family medicine is an integral part of primary care within health systems. Globally, training programmes exhibit a great degree of variability in content and skill acquisition. While this may in part reflect the needs of a given setting, there exists standard criteria that all family medicine programmes should consider core activities. WONCA has provided an open-access list of standards that their expert community considers essential for family medicine (GP) post-graduate training. Evaluation of developing or existing training programmes using these standards can provide insight into the degree of variability, gaps within programmes and equally as important, gaps within recommendations. In collaboration with the host institution, two family medicine programmes in Nepal and Myanmar were evaluated based on WONCA global standards. The results of the evaluation demonstrated that such a process can allow for critical review of curriculum in various stages of development and evaluation. The implications of reviewing training programmes according to WONCA standards can lead to enhanced training world-wide and standardisation of training for post-graduate family medicine.

The Czechoslovak legal regulation of family relations affected by development in medicine.

PubMed

Dragonec, J

1990-01-01

Medicine has developed rapidly during the last decades. Transplantation, sex-change surgery in transsexual or heterosexual persons, interference in the process of reproduction of human species and procedures like lobotomy have remarkably expanded the possibilities of contemporary medicine. This, at the same time gives rise to unprecedented legal problems. A number of them have not yet been solved in many countries, though legislative solutions are sought. The road to their solution, however, is full of blind curves: no sooner does the law offer an answer to one problem than medicine demands the answer to another, brand new one. This is why knowledge of these problems' regulation in different countries might be of use. That article gives an outline of their regulation in Czechoslovakia.

Consensus statement on advancing research in emergency department operations and its impact on patient care.

PubMed

Yiadom, Maame Yaa A B; Ward, Michael J; Chang, Anna Marie; Pines, Jesse M; Jouriles, Nick; Yealy, Donald M

2015-06-01

The consensus conference on "Advancing Research in Emergency Department (ED) Operations and Its Impact on Patient Care," hosted by The ED Operations Study Group (EDOSG), convened to craft a framework for future investigations in this important but understudied area. The EDOSG is a research consortium dedicated to promoting evidence-based clinical practice in emergency medicine. The consensus process format was a modified version of the NIH Model for Consensus Conference Development. Recommendations provide an action plan for how to improve ED operations study design, create a facilitating research environment, identify data measures of value for process and outcomes research, and disseminate new knowledge in this area. Specifically, we call for eight key initiatives: 1) the development of universal measures for ED patient care processes; 2) attention to patient outcomes, in addition to process efficiency and best practice compliance; 3) the promotion of multisite clinical operations studies to create more generalizable knowledge; 4) encouraging the use of mixed methods to understand the social community and human behavior factors that influence ED operations; 5) the creation of robust ED operations research registries to drive stronger evidence-based research; 6) prioritizing key clinical questions with the input of patients, clinicians, medical leadership, emergency medicine organizations, payers, and other government stakeholders; 7) more consistently defining the functional components of the ED care system, including observation units, fast tracks, waiting rooms, laboratories, and radiology subunits; and 8) maximizing multidisciplinary knowledge dissemination via emergency medicine, public health, general medicine, operations research, and nontraditional publications. © 2015 by the Society for Academic Emergency Medicine.

[The certification of advanced therapy medicinal products. A quality label for product development in small and medium-sized enterprises].

PubMed

Berger, A; Schüle, S; Flory, E

2011-07-01

Advanced therapy medicinal products (ATMPs) are gene therapy, cell therapy, and tissue engineered products. To gain access to the market within the European Union, ATMPs must be authorized by the European Commission (EC). Especially for small and medium-sized enterprises (SMEs), the European centralized procedure of marketing authorization that is conducted by the European Medicines Agency (EMA) constitutes a major challenge, because SMEs often have little experience with regulatory procedures and many have limited financial possibilities. To tackle these challenges, a certification procedure exclusively for SMEs and their ATMP development was introduced by the EC. Independently from a marketing authorization application, development and/or production processes can be certified. An issued certificate demonstrates that the respective process meets the current regulatory and scientific requirements of the EMA, representing a valuable milestone for putative investors and licensees. This article highlights the background, the detailed procedure, the minimum requirements, as well as the costs of certification, while giving further noteworthy guidance for interested parties.

Developing a framework to guide the de-adoption of low-value clinical practices in acute care medicine: a study protocol.

PubMed

Parsons Leigh, Jeanna; Niven, Daniel J; Boyd, Jamie M; Stelfox, Henry T

2017-01-19

Healthcare systems have difficulty incorporating scientific evidence into clinical practice, especially when science suggests that existing clinical practices are of low-value (e.g. ineffective or harmful to patients). While a number of lists outlining low-value practices in acute care medicine currently exist, less is known about how best to initiate and sustain the removal of low-value clinical practices (i.e. de-adoption). This study will develop a comprehensive list of barriers and facilitators to the de-adoption of low-value clinical practices in acute care facilities to inform the development of a framework to guide the de-adoption process. The proposed project is a multi-stage mixed methods study to develop a framework to guide the de-adoption of low-value clinical practices in acute care medicine that will be tested in a representative sample of acute care settings in Alberta, Canada. Specifically, we will: 1) conduct a systematic review of the de-adoption literature to identify published barriers and facilitators to the de-adoption of low-value clinical practices in acute care medicine and any associated interventions proposed (Phase one); 2) conduct focus groups with acute care stakeholders to identify important themes not published in the literature and obtain a comprehensive appreciation of stakeholder perspectives (Phase two); 3) extend the generalizability of focus group findings by conducting individual stakeholder surveys with a representative sample of acute care providers throughout the province to determine which barriers and facilitators identified in Phases one and two are most relevant in their clinical setting (Phase three). Identified barriers and facilitators will be catalogued and integrated with targeted interventions in a framework to guide the process of de-adoption in each of four targeted areas of acute care medicine (Emergency Medicine, Cardiovascular Health and Stroke, Surgery and Critical Care Medicine). Analyses will be descriptive using a combination of qualitative and quantitative analyses. There is a growing body of literature suggesting that the de-adoption of ineffective or harmful practices from patient care is integral to the delivery of high quality care and healthcare sustainability. The framework developed in this study will map barriers and facilitators to de-adoption to the most appropriate interventions, allowing stakeholders to effectively initiate, execute and sustain this process in an evidence-based manner.

[Applicability of non-invasive imaging methods in forensic medicine and forensic anthropology in particular].

PubMed

Marcinková, Mária; Straka, Ľubomír; Novomeský, František; Janík, Martin; Štuller, František; Krajčovič, Jozef

2018-01-01

Massive progress in developing even more precise imaging modalities influenced all medical branches including the forensic medicine. In forensic anthropology, an inevitable part of forensic medicine itself, the use of all imaging modalities becomes even more important. Despite of acquiring more accurate informations about the deceased, all of them can be used in the process of identification and/or age estimation. X - ray imaging is most commonly used in detecting foreign bodies or various pathological changes of the deceased. Computed tomography, on the other hand, can be very helpful in the process of identification, whereas outcomes of this examination can be used for virtual reconstruction of living objects. Magnetic resonance imaging offers new opportunities in detecting cardiovascular pathological processes or develompental anomalies. Ultrasonography provides promising results in age estimation of living subjects without excessive doses of radiation. Processing the latest information sources available, authors introduce the application examples of X - ray imaging, computed tomography, magnetic resonance imaging and ultrasonography in everyday forensic medicine routine, with particular focusing on forensic anthropology.

Integrating biomedical and herbal medicine in Ghana - experiences from the Kumasi South Hospital: a qualitative study.

PubMed

Boateng, Millicent Addai; Danso-Appiah, Anthony; Turkson, Bernard Kofi; Tersbøl, Britt Pinkowski

2016-07-07

Over the past decade there has been growing interest in the use of herbal medicine both in developed and developing countries. Given the high proportion of patients using herbal medicine in Ghana, some health facilities have initiated implementation of herbal medicine as a component of their healthcare delivery. However, the extent to which herbal medicine has been integrated in Ghanaian health facilities, how integration is implemented and perceived by different stakeholders has not been documented. The study sought to explore these critical issues at the Kumasi South Hospital (KSH) and outline the challenges and motivations of the integration process. Qualitative phenomenological exploratory study design involving fieldwork observations, focus group discussion, in-depth interviews and key informants' interviews was employed to collect data. Policies and protocols outlining the definition, process and goals of integration were lacking, with respondents sharing different views about the purpose and value of integration of herbal medicine within public health facilities. Key informants were supportive of the initiative. Whilst biomedical health workers perceived the system to be parallel than integrated, health personnel providing herbal medicine perceived the system as integrated. Most patients were not aware of the herbal clinic in the hospital but those who had utilized services of the herbal clinic viewed the clinic as part of the hospital. The lack of a regulatory policy and protocol for the integration seemed to have led to the different perception of the integration. Policy and protocol to guide the integration are key recommendations.

27 CFR 21.40 - Formula No. 12-A.

Code of Federal Regulations, 2010 CFR

2010-04-01

... chemicals. 359.Processing miscellaneous products. 430.Sterilizing and preserving solutions. (2) As a raw... chemicals (including alkaloids). 345.Processing blood and blood products. 351.Processing dyes and... medicinal chemicals. 579.Other chemicals. (3) Miscellaneous uses: 812.Product development and pilot plant...

27 CFR 21.40 - Formula No. 12-A.

Code of Federal Regulations, 2011 CFR

2011-04-01

... chemicals. 359.Processing miscellaneous products. 430.Sterilizing and preserving solutions. (2) As a raw... chemicals (including alkaloids). 345.Processing blood and blood products. 351.Processing dyes and... medicinal chemicals. 579.Other chemicals. (3) Miscellaneous uses: 812.Product development and pilot plant...

27 CFR 21.41 - Formula No. 13-A.

Code of Federal Regulations, 2013 CFR

2013-04-01

.... 579.Other chemicals. (3) Miscellaneous uses: 812.Product development and pilot plant uses (own use... medicinal chemicals (including alkaloids). 345.Processing blood and blood products. 349.Miscellaneous drug... photographic chemicals. 358.Processing other chemicals. 359.Processing miscellaneous products. 430.Sterilizing...

Telemedicine and distributed medical intelligence.

PubMed

Warner, D; Tichenor, J M; Balch, D C

1996-01-01

Recent trends in health care informatics and telemedicine indicate that systems are being developed with a primary focus on technology and business, not on the process of medicine itself. The authors present a new model of health care information, distributed medical intelligence, which promotes the development of an integrative medical communication system addressing the process of providing expert medical knowledge to the point of need. The model incorporates audio, video, high-resolution still images, and virtual reality applications into an integrated medical communications network. Three components of the model (care portals, Docking Station, and the bridge) are described. The implementation of this model at the East Carolina University School of Medicine is also outlined.

[Research and development strategies in classical herbal formulae].

PubMed

Chen, Chang; Cheng, Jin-Tang; Liu, An

2017-05-01

As an outstanding representative of traditional Chinese medicine prescription, classical herbal formulae are the essence of traditional Chinese medicine great treasure. To support the development of classical herbal formulae, the state and relevant administrative departments have successively promulgated the relevant encouraged policies.But some key issues of classic herbal formulae in the development process have not reached a unified consensus and standard, and these problems were discussed in depth here.The authors discussed the registration requirements of classical herbal formulae, proposed the screening specific indicators of classical herbal formulae, determination basis of prescription and dosage,screening method of production process, and the basic principle of clinical localization, in order to bring out valuable opinions and provide a reference for classical herbal formulae development and policy formulation. Copyright© by the Chinese Pharmaceutical Association.

Osteopathic approach to implementing and promoting interprofessional education.

PubMed

Mackintosh, Susan E; Adams, Clinton E; Singer-Chang, Gail; Hruby, Raymond J

2011-04-01

Multidisciplinary fragmentation contributes to myriad medical errors and as many as 98,000 patient deaths per year. The Institute of Medicine has proposed steps to improve healthcare delivery, including providing more opportunities for interdisciplinary training. The authors describe the interprofessional education (IPE) program at Western University of Health Sciences (WesternU) in Pomona, California. In 2007, 9 colleges at WesternU-including the College of Osteopathic Medicine of the Pacific-undertook an IPE initiative that resulted in creation of a 3-phase program. Part of the IPE development process involved identifying core competencies that were nontechnical and nonclinical and common to all healthcare professions. The IPE development and implementation process and the identified competencies were analyzed for their relationship to the tenets of osteopathic medicine and the core competencies of osteopathic medical education. Although these tenets and core competencies were not intentionally used in the development process of the WesternU IPE program, the analysis revealed that the major components of the program are congruent with the framework of osteopathic principles and practice. The osteopathic medical profession's founding principles, broad-based perspective, and health-promoting tenets put the profession in a position to emerge as one of the leading forces in IPE.

Is nanotechnology the key to unravel and engineer biological processes?

PubMed

Navarro, Melba; Planell, Josep A

2012-01-01

Regenerative medicine is an emerging field aiming to the development of new reparative strategies to treat degenerative diseases, injury, and trauma through developmental pathways in order to rebuild the architecture of the original injured organ and take over its functionality. Most of the processes and interactions involved in the regenerative process take place at subcellular scale. Nanotechnology provides the tools and technology not only to detect, to measure, or to image the interactions between the different biomolecules and biological entities, but also to control and guide the regenerative process. The relevance of nanotechnology for the development of regenerative medicine as well as an overview of the different tools that contribute to unravel and engineer biological systems are presented in this chapter. In addition, general data about the social impact and global investment in nanotechnology are provided.

Medicine and the humanities--theoretical and methodological issues.

PubMed

Puustinen, Raimo; Leiman, M; Viljanen, A M

2003-12-01

Engel's biopsychosocial model, Cassell's promotion of the concept "person" in medical thinking and Pellegrino's and Thomasma's philosophy of medicine are attempts to widen current biomedical theory of disease and to approach medicine as a form of human activity in pursuit of healing. To develop this approach further we would like to propose activity theory as a possible means for understanding the nature of medical practice. By "activity theory" we refer to developments which have evolved from Vygotsky's research on socially mediated mental functions and processes. Analysing medicine as activity enforces the joint consideration of target and subject: who is doing what to whom. This requires the use of historical, linguistic, anthropological, and semiotic tools. Therefore, if we analyse medicine as an activity, humanities are both theoretically and methodologically "inbound" (or internal) to the analysis itself. On the other hand, literature studies or anthropological writings provide material for analysing the various forms of medical practices.

Guidelines for fellowship training in Regional Anesthesiology and Acute Pain Medicine: Second Edition, 2010.

PubMed

2011-01-01

The Regional Anesthesiology and Acute Pain Medicine Fellowship Directors Group develops and maintains guidelines for fellowship training in the subspecialty. These guidelines update the original guidelines that were published in 2005. The guidelines address 3 major topic areas: organization and resources, the educational program, and the evaluation process.

[Development and application of component-based Chinese medicine theory].

PubMed

Zhang, Jun-Hua; Fan, Guan-Wei; Zhang, Han; Fan, Xiao-Hui; Wang, Yi; Liu, Li-Mei; Li, Chuan; Gao, Yue; Gao, Xiu-Mei; Zhang, Bo-Li

2017-11-01

Traditional Chinese medicine (TCM) prescription is the main therapies for disease prevention and treatment in Chinese medicine. Following the guidance of the theory of TCM and developing drug by composing prescriptions of TCM materials and pieces, it is a traditional application mode of TCM, and still widely used in clinic. TCM prescription has theoretical advantages and rich clinical application experience in dealing with multi-factor complex diseases, but scientific research is relatively weak. The lack of scientific cognition of the effective substances and mechanism of Chinese medicine leads to insufficient understanding of the efficacy regularity, which affects the stability of effect and hinders the improvement of quality of Chinese medicinal products. Component-based Chinese medicine (CCM) is an innovation based on inheritance, which breaks through the tradition of experience-based prescription and realize the transformation of compatibility from herbal pieces to components. CCM is an important achievement during the research process of modernization of Chinese medicine. Under the support of three national "973" projects, in order to reveal the scientific connotation of the prescription compatibility theory and develop innovative Chinese drugs, we have launched theoretical innovation and technological innovation around the "two relatively clear", and opened up the research field of CCM. CCM is an innovation based on inheritance, breaking through the tradition of experience based prescription, and realizing the transformation from compatibility of herbal pieces to component compatibility, which is an important achievement of the modernization of traditional Chinese medicine. In the past more than 10 years, with the deepening of research and the expansion of application, the theory and methods of CCM and efficacy-oriented compatibility have been continuously improved. The value of CCM is not only in developing new drug, more important is to build a communication bridge between traditional Chinese medicine and modern science and construct the system of key technologies which meet the need of innovation and development of TCM. This paper focused on the research progress, related concepts and technology development of CCM, as well as its application prospect in the theory research of Chinese medicine, development of innovative Chinese drugs, secondary development of Chinese patent medicine and upgrading of pharmaceutical technology. Copyright© by the Chinese Pharmaceutical Association.

Harnessing Biomedical Natural Language Processing Tools to Identify Medicinal Plant Knowledge from Historical Texts.

PubMed

Sharma, Vivekanand; Law, Wayne; Balick, Michael J; Sarkar, Indra Neil

2017-01-01

The growing amount of data describing historical medicinal uses of plants from digitization efforts provides the opportunity to develop systematic approaches for identifying potential plant-based therapies. However, the task of cataloguing plant use information from natural language text is a challenging task for ethnobotanists. To date, there have been only limited adoption of informatics approaches used for supporting the identification of ethnobotanical information associated with medicinal uses. This study explored the feasibility of using biomedical terminologies and natural language processing approaches for extracting relevant plant-associated therapeutic use information from historical biodiversity literature collection available from the Biodiversity Heritage Library. The results from this preliminary study suggest that there is potential utility of informatics methods to identify medicinal plant knowledge from digitized resources as well as highlight opportunities for improvement.

Harnessing Biomedical Natural Language Processing Tools to Identify Medicinal Plant Knowledge from Historical Texts

PubMed Central

Sharma, Vivekanand; Law, Wayne; Balick, Michael J.; Sarkar, Indra Neil

2017-01-01

The growing amount of data describing historical medicinal uses of plants from digitization efforts provides the opportunity to develop systematic approaches for identifying potential plant-based therapies. However, the task of cataloguing plant use information from natural language text is a challenging task for ethnobotanists. To date, there have been only limited adoption of informatics approaches used for supporting the identification of ethnobotanical information associated with medicinal uses. This study explored the feasibility of using biomedical terminologies and natural language processing approaches for extracting relevant plant-associated therapeutic use information from historical biodiversity literature collection available from the Biodiversity Heritage Library. The results from this preliminary study suggest that there is potential utility of informatics methods to identify medicinal plant knowledge from digitized resources as well as highlight opportunities for improvement. PMID:29854223

[Application of risk-based approach for determination of critical factors in technology transfer of production of medicinal products].

PubMed

Beregovykh, V V; Spitskiy, O R

2014-01-01

Risk-based approach is used for examination of impact of different factors on quality of medicinal products in technology transfer. A general diagram is offered for risk analysis execution in technology transfer from pharmaceutical development to production. When transferring technology to full- scale commercial production it is necessary to investigate and simulate production process application beforehand in new real conditions. The manufacturing process is the core factorfor risk analysis having the most impact on quality attributes of a medicinal product. Further importantfactors are linked to materials and products to be handled and manufacturing environmental conditions such as premises, equipment and personnel. Usage of risk-based approach in designing of multipurpose production facility of medicinal products is shown where quantitative risk analysis tool RAMM (Risk Analysis and Mitigation Matrix) was applied.

Expert consensus v. evidence-based approaches in the revision of the DSM.

PubMed

Kendler, K S; Solomon, M

2016-08-01

The development of DSM-III through DSM-5 has relied heavily on expert consensus. In this essay, we provide an historical and critical perspective on this process. Over the last 40 years, medicine has struggled to find appropriate methods for summarizing research results and making clinical recommendations. When such recommendations are issued by authorized organizations, they can have widespread influence (i.e. DSM-III and its successors). In the 1970s, expert consensus conferences, led by the NIH, reviewed research about controversial medical issues and successfully disseminated results. However, these consensus conferences struggled with aggregating the complex available evidence. In the 1990s, the rise of evidence-based medicine cast doubt on the reliability of expert consensus. Since then, medicine has increasingly relied on systematic reviews, as developed by the evidence-based medicine movement, and advocated for their early incorporation in expert consensus efforts. With the partial exception of DSM-IV, such systematic evidence-based reviews have not been consistently integrated into the development of the DSMs, leaving their development out of step with the larger medical field. Like the recommendations made for the NIH consensus conferences, we argue that the DSM process should be modified to require systematic evidence-based reviews before Work Groups make their assessments. Our suggestions - which would require leadership and additional resources to set standards for appropriate evidence hierarchies, carry out systematic reviews, and upgrade the group process - should improve the objectivity of the DSM, increase the validity of its results, and improve the reception of any changes in nosology.

Diabetes Medicines

MedlinePlus

... Process Research Training & Career Development Funded Grants & Grant History Research Resources Research at NIDDK Technology Advancement & Transfer Meetings & Workshops Health Information Diabetes Digestive ...

Development of Software for Automatic Analysis of Intervention in the Field of Homeopathy.

PubMed

Jain, Rajesh Kumar; Goyal, Shagun; Bhat, Sushma N; Rao, Srinath; Sakthidharan, Vivek; Kumar, Prasanna; Sajan, Kannanaikal Rappayi; Jindal, Sameer Kumar; Jindal, Ghanshyam D

2018-05-01

To study the effect of homeopathic medicines (in higher potencies) in normal subjects, Peripheral Pulse Analyzer (PPA) has been used to record physiologic variability parameters before and after administration of the medicine/placebo in 210 normal subjects. Data have been acquired in seven rounds; placebo was administered in rounds 1 and 2 and medicine in potencies 6, 30, 200, 1 M, and 10 M was administered in rounds 3 to 7, respectively. Five different medicines in the said potencies were given to a group of around 40 subjects each. Although processing of data required human intervention, a software application has been developed to analyze the processed data and detect the response to eliminate the undue delay as well as human bias in subjective analysis. This utility named Automatic Analysis of Intervention in the Field of Homeopathy is run on the processed PPA data and the outcome has been compared with the manual analysis. The application software uses adaptive threshold based on statistics for detecting responses in contrast to fixed threshold used in manual analysis. The automatic analysis has detected 12.96% higher responses than subjective analysis. Higher response rates have been manually verified to be true positive. This indicates robustness of the application software. The automatic analysis software was run on another set of pulse harmonic parameters derived from the same data set to study cardiovascular susceptibility and 385 responses were detected in contrast to 272 of variability parameters. It was observed that 65% of the subjects, eliciting response, were common. This not only validates the software utility for giving consistent yield but also reveals the certainty of the response. This development may lead to electronic proving of homeopathic medicines (e-proving).

[Digital x-ray image processing as an aid in forensic medicine].

PubMed

Buitrago-Tellez, C; Wenz, W; Friedrich, G

1992-02-01

Radiology plays an important role in the identification of unknown corpses. Positive radiographic identification by comparison with antemortem films is an established technique in this setting. Technical defects together with non-well-preserved films make it sometimes difficult or even impossible to establish a confident comparison. Digital image processing after secondary digitalization of ante- and postmortem films represents an important development and aid in forensic medicine. The application of this method is demonstrated on a single case.

Systems biology-based diagnostic principles as pillars of the bridge between Chinese and Western medicine.

PubMed

van der Greef, Jan; van Wietmarschen, Herman; Schroën, Jan; Wang, Mei; Hankemeier, Thomas; Xu, Guowang

2010-12-01

Innovative systems approaches to develop medicine and health care are emerging from the integration of Chinese and Western medicine strategies, philosophies and practices. The two medical systems are highly complementary as the reductionist aspects of Western medicine are favourable in acute disease situations and the holistic aspects of Chinese medicine offer more opportunities in chronic conditions and for prevention. In this article we argue that diagnosis plays a key role in building the bridge between Chinese and Western medicine. Recent advances in the study of health, healing, placebo effects and patient-physician interactions will be discussed pointing out the development of a system-based diagnosis. Especially, a system biology-based diagnosis can be used to capture phenotype information, leading towards a scientific basis for a more refined patient characterization, new diagnostic tools and personalized heath strategies. Subtyping of rheumatoid arthritis patients based on Chinese diagnostic principles is discussed as an example. New insights from this process of integrating Western and Chinese medicine will pave the way for a patient-centred health care ecosystem. © Georg Thieme Verlag KG Stuttgart · New York.

Proteomics and syndrome of Chinese medicine

PubMed Central

Lu, Chuan-Li; Qv, Xiao-Ying; Jiang, Jian-Guo

2010-01-01

Abstract Syndrome of Chinese medicine is an understanding of the regularity of disease occurrence and development and its performance of symptoms. Syndrome is the key to recognize diseases and the foundation to treat them. However, because of the complexity of the concept and the limitation of present investigations, the research of syndrome is hard to go further. Proteomics has been received extensive attention in the area of medical diagnosis and drug development. In the holistic and systemic context, proteomics have a convergence with traditional Chinese medicine (TCM) syndrome, which could overcome the one-sidedness and singleness of TCM and avoid the complication and tedious processes. Chinese medicine has a wealth of experience and proteomics has a substantial research potential, the integration of the two aspects will bring a great enhancement of our knowledge of disease. PMID:20874721

Examining Quality Management Audits in Nuclear Medicine Practice as a lifelong learning process: opportunities and challenges to the nuclear medicine professional and beyond.

PubMed

Pascual, Thomas N B

2016-08-01

This essay will explore the critical issues and challenges surrounding lifelong learning for professionals, initially exploring within the profession and organizational context of nuclear medicine practice. It will critically examine how the peer-review process called Quality Management Audits in Nuclear Medicine Practice (QUANUM) of the International Atomic Energy Agency (IAEA) can be considered a lifelong learning opportunity to instill a culture of quality to improve patient care and elevate the status of the nuclear medicine profession and practice within the demands of social changes, policy, and globalization. This will be explored initially by providing contextual background to the identity of the IAEA as an organization responsible for nuclear medicine professionals, followed by the benefits that QUANUM can offer. Further key debates surrounding lifelong learning, such as compulsification of lifelong learning and impact on professional change, will then be weaved through the discussion using theoretical grounding through a qualitative review of the literature. Keeping in mind that there is very limited literature focusing on the implications of QUANUM as a lifelong learning process for nuclear medicine professionals, this essay uses select narratives and observations of QUANUM as a lifelong learning process from an auditor's perspective and will further provide a comparative perspective of QUANUM on the basis of other lifelong learning opportunities such as continuing professional development activities and observe parallelisms on its benefits and challenges that it will offer to other professionals in other medical speciality fields and in the teaching profession.

[Development and application of emergency medical information management system].

PubMed

Wang, Fang; Zhu, Baofeng; Chen, Jianrong; Wang, Jian; Gu, Chaoli; Liu, Buyun

2011-03-01

To meet the needs of clinical practice of rescuing critical illness and develop the information management system of the emergency medicine. Microsoft Visual FoxPro, which is one of Microsoft's visual programming tool, is used to develop computer-aided system included the information management system of the emergency medicine. The system mainly consists of the module of statistic analysis, the module of quality control of emergency rescue, the module of flow path of emergency rescue, the module of nursing care in emergency rescue, and the module of rescue training. It can realize the system management of emergency medicine and,process and analyze the emergency statistical data. This system is practical. It can optimize emergency clinical pathway, and meet the needs of clinical rescue.

[Development of an instrument for the surveillance of quality indicators in specialized training in Preventive Medicine and Public Health].

PubMed

Gil-Borrelli, Christian Carlo; Latasa, Pello; Reques, Laura; Alemán, Guadalupe

2015-01-01

This study describes the process of developing an instrument intended for use in assessing satisfaction with the quality of training in preventive medicine and public health for resident physicians. To develop this instrument, the National Survey of Satisfaction with Medical Residency was adapted by an expert panel consisting of 23 resident physicians in preventive medicine and public health belonging to 9 autonomous communities in Spain. The adaptation of the survey to the specialty rotations included new dimensions and items and was evaluated with a 5-point Likert scale. The most important dimensions were planning and the achievement of specific objectives, supervision, delegation of responsibilities, resources and work environment, personal assessment, encouragement, support, and whether the rotation resulted in a publication or research project, etc. The development and utilization of this tool will enable future trainees in preventive medicine and public health to make an informed choice about their training itineraries. Copyright © 2015 SESPAS. Published by Elsevier Espana. All rights reserved.

The Long and Winding Road to Innovation.

PubMed

Beyar, Rafael

2015-07-30

Medicine is developing through biomedical technology and innovations. The goal of any innovation in medicine is to improve patient care. Exponential growth in technology has led to the unprecedented growth of medical technology over the last 50 years. Clinician-scientists need to understand the complexity of the innovation process, from concept to product release, when working to bring new clinical solutions to the bedside. Hence, an overview of the innovation process is provided herein. The process involves an invention designed to solve an unmet need, followed by prototype design and optimization, animal studies, pilot and pivotal studies, and regulatory approval. The post-marketing strategy relative to funding, along with analysis of cost benefit, is a critical component for the adoption of new technologies. Examples of the road to innovation are provided, based on the experience with development of the transcatheter aortic valve. Finally, ideas are presented to contribute to the further development of this worldwide trend in innovation.

The Long and Winding Road to Innovation

PubMed Central

Beyar, Rafael

2015-01-01

Medicine is developing through biomedical technology and innovations. The goal of any innovation in medicine is to improve patient care. Exponential growth in technology has led to the unprecedented growth of medical technology over the last 50 years. Clinician-scientists need to understand the complexity of the innovation process, from concept to product release, when working to bring new clinical solutions to the bedside. Hence, an overview of the innovation process is provided herein. The process involves an invention designed to solve an unmet need, followed by prototype design and optimization, animal studies, pilot and pivotal studies, and regulatory approval. The post-marketing strategy relative to funding, along with analysis of cost benefit, is a critical component for the adoption of new technologies. Examples of the road to innovation are provided, based on the experience with development of the transcatheter aortic valve. Finally, ideas are presented to contribute to the further development of this worldwide trend in innovation. PMID:26241234

Systems Medicine: Sketching the Landscape.

PubMed

Kirschner, Marc

2016-01-01

To understand the meaning of the term Systems Medicine and to distinguish it from seemingly related other expressions currently in use, such as precision, personalized, -omics, or big data medicine, its underlying history and development into present time needs to be highlighted. Having this development in mind, it becomes evident that Systems Medicine is a genuine concept as well as a novel way of tackling the manifold complexity that occurs in nowadays clinical medicine-and not just a rebranding of what has previously been done in the past. So looking back it seems clear to many in the field that Systems Medicine has its origin in an integrative method to unravel biocomplexity, namely, Systems Biology. Here scientist by now gained useful experience that is on the verge toward implementation in clinical research and practice.Systems Medicine and Systems Biology have the same underlying theoretical principle in systems-based thinking-a methodology to understand complexity that can be traced back to ancient Greece. During the last decade, however, and due to a rapid methodological development in the life sciences and computing/IT technologies, Systems Biology has evolved from a scientific concept into an independent discipline most competent to tackle key questions of biocomplexity-with the potential to transform medicine and how it will be practiced in the future. To understand this process in more detail, the following section will thus give a short summary of the foundation of systems-based thinking and the different developmental stages including systems theory, the development of modern Systems Biology, and its transition into clinical practice. These are the components to pave the way toward Systems Medicine.

Medicinal chemistry inspired fragment-based drug discovery.

PubMed

Lanter, James; Zhang, Xuqing; Sui, Zhihua

2011-01-01

Lead generation can be a very challenging phase of the drug discovery process. The two principal methods for this stage of research are blind screening and rational design. Among the rational or semirational design approaches, fragment-based drug discovery (FBDD) has emerged as a useful tool for the generation of lead structures. It is particularly powerful as a complement to high-throughput screening approaches when the latter failed to yield viable hits for further development. Engagement of medicinal chemists early in the process can accelerate the progression of FBDD efforts by incorporating drug-friendly properties in the earliest stages of the design process. Medium-chain acyl-CoA synthetase 2b and ketohexokinase are chosen as examples to illustrate the importance of close collaboration of medicinal chemists, crystallography, and modeling. Copyright © 2011 Elsevier Inc. All rights reserved.

A behavioral science/behavioral medicine core curriculum proposal for Japanese undergraduate medical education.

PubMed

Tsutsumi, Akizumi

2015-01-01

Behavioral science and behavioral medicine have not been systematically taught to Japanese undergraduate medical students. A working group under the auspices of Japanese Society of Behavioral Medicine developed an outcome-oriented curriculum of behavioral science/behavioral medicine through three processes: identifying the curriculum contents, holding a joint symposium with related societies, and defining outcomes and proposing a learning module. The behavioral science/behavioral medicine core curriculum consists of 11 units of lectures and four units of practical study. The working group plans to improve the current core curriculum by devising formative assessment methods so that students can learn and acquire attitude as well as the skills and knowledge necessary for student-centered clinical practice.

Developing a Common Framework for Evaluating the Implementation of Genomic Medicine Interventions in Clinical Care: The IGNITE Network’s Common Measures Working Group

PubMed Central

Orlando, Lori A.; Sperber, Nina R.; Voils, Corrine; Nichols, Marshall; Myers, Rachel A.; Wu, R. Ryanne; Rakhra-Burris, Tejinder; Levy, Kenneth D.; Levy, Mia; Pollin, Toni I.; Guan, Yue; Horowitz, Carol R.; Ramos, Michelle; Kimmel, Stephen E.; McDonough, Caitrin W.; Madden, Ebony B.; Damschroder, Laura J.

2017-01-01

Purpose Implementation research provides a structure for evaluating the clinical integration of genomic medicine interventions. This paper describes the Implementing GeNomics In PracTicE (IGNITE) Network’s efforts to promote: 1) a broader understanding of genomic medicine implementation research; and 2) the sharing of knowledge generated in the network. Methods To facilitate this goal the IGNITE Network Common Measures Working Group (CMG) members adopted the Consolidated Framework for Implementation Research (CFIR) to guide their approach to: identifying constructs and measures relevant to evaluating genomic medicine as a whole, standardizing data collection across projects, and combining data in a centralized resource for cross network analyses. Results CMG identified ten high-priority CFIR constructs as important for genomic medicine. Of those, eight didn’t have standardized measurement instruments. Therefore, we developed four survey tools to address this gap. In addition, we identified seven high-priority constructs related to patients, families, and communities that did not map to CFIR constructs. Both sets of constructs were combined to create a draft genomic medicine implementation model. Conclusion We developed processes to identify constructs deemed valuable for genomic medicine implementation and codified them in a model. These resources are freely available to facilitate knowledge generation and sharing across the field. PMID:28914267

Developing a common framework for evaluating the implementation of genomic medicine interventions in clinical care: the IGNITE Network's Common Measures Working Group.

PubMed

Orlando, Lori A; Sperber, Nina R; Voils, Corrine; Nichols, Marshall; Myers, Rachel A; Wu, R Ryanne; Rakhra-Burris, Tejinder; Levy, Kenneth D; Levy, Mia; Pollin, Toni I; Guan, Yue; Horowitz, Carol R; Ramos, Michelle; Kimmel, Stephen E; McDonough, Caitrin W; Madden, Ebony B; Damschroder, Laura J

2018-06-01

PurposeImplementation research provides a structure for evaluating the clinical integration of genomic medicine interventions. This paper describes the Implementing Genomics in Practice (IGNITE) Network's efforts to promote (i) a broader understanding of genomic medicine implementation research and (ii) the sharing of knowledge generated in the network.MethodsTo facilitate this goal, the IGNITE Network Common Measures Working Group (CMG) members adopted the Consolidated Framework for Implementation Research (CFIR) to guide its approach to identifying constructs and measures relevant to evaluating genomic medicine as a whole, standardizing data collection across projects, and combining data in a centralized resource for cross-network analyses.ResultsCMG identified 10 high-priority CFIR constructs as important for genomic medicine. Of those, eight did not have standardized measurement instruments. Therefore, we developed four survey tools to address this gap. In addition, we identified seven high-priority constructs related to patients, families, and communities that did not map to CFIR constructs. Both sets of constructs were combined to create a draft genomic medicine implementation model.ConclusionWe developed processes to identify constructs deemed valuable for genomic medicine implementation and codified them in a model. These resources are freely available to facilitate knowledge generation and sharing across the field.

Interprofessional Competencies in Integrative Primary Healthcare

PubMed Central

Brooks, Audrey J.; Maizes, Victoria; Goldblatt, Elizabeth; Klatt, Maryanna; Koithan, Mary S.; Kreitzer, Mary Jo; Lee, Jeannie K.; Lopez, Ana Marie; McClafferty, Hilary; Rhode, Robert; Sandvold, Irene; Saper, Robert; Taren, Douglas; Wells, Eden; Lebensohn, Patricia

2015-01-01

In October 2014, the National Center for Integrative Primary Healthcare (NCIPH) was launched as a collaboration between the University of Arizona Center for Integrative Medicine and the Academic Consortium for Integrative Health and Medicine and supported by a grant from the Health Resources and Services Administration. A primary goal of the NCIPH is to develop a core set of integrative healthcare (IH) competencies and educational programs that will span the interprofessional primary care training and practice spectra and ultimately become a required part of primary care education. This article reports on the first phase of the NCIPH effort, which focused on the development of a shared set of competencies in IH for primary care disciplines. The process of development, refinement, and adoption of 10 “meta-competencies” through a collaborative process involving a diverse interprofessional team is described. Team members represent nursing, the primary care medicine professions, pharmacy, public health, acupuncture, naturopathy, chiropractic, nutrition, and behavioral medicine. Examples of the discipline-specific sub-competencies being developed within each of the participating professions are provided, along with initial results of an assessment of potential barriers and facilitators of adoption within each discipline. The competencies presented here will form the basis of a 45-hour online curriculum produced by the NCIPH for use in primary care training programs that will be piloted in a wide range of programs in early 2016 and then revised for wider use over the following year. PMID:26421232

DNA Barcoding for the Identification and Authentication of Animal Species in Traditional Medicine.

PubMed

Yang, Fan; Ding, Fei; Chen, Hong; He, Mingqi; Zhu, Shixin; Ma, Xin; Jiang, Li; Li, Haifeng

2018-01-01

Animal-based traditional medicine not only plays a significant role in therapeutic practices worldwide but also provides a potential compound library for drug discovery. However, persistent hunting and illegal trade markedly threaten numerous medicinal animal species, and increasing demand further provokes the emergence of various adulterants. As the conventional methods are difficult and time-consuming to detect processed products or identify animal species with similar morphology, developing novel authentication methods for animal-based traditional medicine represents an urgent need. During the last decade, DNA barcoding offers an accurate and efficient strategy that can identify existing species and discover unknown species via analysis of sequence variation in a standardized region of DNA. Recent studies have shown that DNA barcoding as well as minibarcoding and metabarcoding is capable of identifying animal species and discriminating the authentics from the adulterants in various types of traditional medicines, including raw materials, processed products, and complex preparations. These techniques can also be used to detect the unlabelled and threatened animal species in traditional medicine. Here, we review the recent progress of DNA barcoding for the identification and authentication of animal species used in traditional medicine, which provides a reference for quality control and trade supervision of animal-based traditional medicine.

DNA Barcoding for the Identification and Authentication of Animal Species in Traditional Medicine

PubMed Central

Yang, Fan; Ding, Fei; Chen, Hong; He, Mingqi; Zhu, Shixin; Ma, Xin; Jiang, Li

2018-01-01

Animal-based traditional medicine not only plays a significant role in therapeutic practices worldwide but also provides a potential compound library for drug discovery. However, persistent hunting and illegal trade markedly threaten numerous medicinal animal species, and increasing demand further provokes the emergence of various adulterants. As the conventional methods are difficult and time-consuming to detect processed products or identify animal species with similar morphology, developing novel authentication methods for animal-based traditional medicine represents an urgent need. During the last decade, DNA barcoding offers an accurate and efficient strategy that can identify existing species and discover unknown species via analysis of sequence variation in a standardized region of DNA. Recent studies have shown that DNA barcoding as well as minibarcoding and metabarcoding is capable of identifying animal species and discriminating the authentics from the adulterants in various types of traditional medicines, including raw materials, processed products, and complex preparations. These techniques can also be used to detect the unlabelled and threatened animal species in traditional medicine. Here, we review the recent progress of DNA barcoding for the identification and authentication of animal species used in traditional medicine, which provides a reference for quality control and trade supervision of animal-based traditional medicine. PMID:29849709

Distributed medical intelligence. A systems approach for developing and integrative health care information distribution infrastructure.

PubMed

Warner, D; Sale, J; Viirre, E

1996-01-01

Recent trends in healthcare informatics and telemedicine indicate that systems are being developed with a primary focus on technology and business, not on the process of medicine itself. Distributed Medical Intelligence promotes the development of an integrative medical communication system which addresses the process of providing expert medical knowledge to the point of need.

Cell Therapy Regulation in Taiwan

PubMed Central

Chen, Yuan-Chuan; Cheng, Hwei-Fang; Yeh, Ming-Kung

2017-01-01

Cell therapy is not only a novel medical practice but also a medicinal product [cell therapy product (CTP)]. More and more CTPs are being approved for marketing globally because of the rapid development of bio-medicine in cell culture, preservation, and preparation. However, regulation is the most important criterion for the development of CTPs. Regulations must be flexible to expedite the process of marketing for new CTPs. Recently, the Taiwan Food and Drug Administration (TFDA) updated the related regulations such as regulation of development, current regulatory framework and process, and the application and evaluation processes. When the quality of CTPs has been improved significantly, their safety and efficacy are further ensured. The treatment protocol, a new design for adaptive licensing to current clinical practice, is a rapid process for patients with life-threatening diseases or serious conditions for which there are no suitable drugs, medical devices, or other therapeutic methods available. The hospital can submit the treatment protocol to apply for cell therapy as a medical practice, which may result in easier and faster cell therapy development, and personalized treatment for individual patients will evolve quickly. PMID:27697103

The Future of Family Medicine: a collaborative project of the family medicine community.

PubMed

Martin, James C; Avant, Robert F; Bowman, Marjorie A; Bucholtz, John R; Dickinson, John R; Evans, Kenneth L; Green, Larry A; Henley, Douglas E; Jones, Warren A; Matheny, Samuel C; Nevin, Janice E; Panther, Sandra L; Puffer, James C; Roberts, Richard G; Rodgers, Denise V; Sherwood, Roger A; Stange, Kurt C; Weber, Cynthia W

2004-01-01

Recognizing fundamental flaws in the fragmented US health care systems and the potential of an integrative, generalist approach, the leadership of 7 national family medicine organizations initiated the Future of Family Medicine (FFM) project in 2002. The goal of the project was to develop a strategy to transform and renew the discipline of family medicine to meet the needs of patients in a changing health care environment. A national research study was conducted by independent research firms. Interviews and focus groups identified key issues for diverse constituencies, including patients, payers, residents, students, family physicians, and other clinicians. Subsequently, interviews were conducted with nationally representative samples of 9 key constituencies. Based in part on these data, 5 task forces addressed key issues to meet the project goal. A Project Leadership Committee synthesized the task force reports into the report presented here. The project identified core values, a New Model of practice, and a process for development, research, education, partnership, and change with great potential to transform the ability of family medicine to improve the health and health care of the nation. The proposed New Model of practice has the following characteristics: a patient-centered team approach; elimination of barriers to access; advanced information systems, including an electronic health record; redesigned, more functional offices; a focus on quality and outcomes; and enhanced practice finance. A unified communications strategy will be developed to promote the New Model of family medicine to multiple audiences. The study concluded that the discipline needs to oversee the training of family physicians who are committed to excellence, steeped in the core values of the discipline, competent to provide family medicine's basket of services within the New Model, and capable of adapting to varying patient needs and changing care technologies. Family medicine education must continue to include training in maternity care, the care of hospitalized patients, community and population health, and culturally effective and proficient care. A comprehensive lifelong learning program for each family physician will support continuous personal, professional, and clinical practice assessment and improvement. Ultimately, systemwide changes will be needed to ensure high-quality health care for all Americans. Such changes include taking steps to ensure that every American has a personal medical home, promoting the use and reporting of quality measures to improve performance and service, advocating that every American have health care coverage for basic services and protection against extraordinary health care costs, advancing research that supports the clinical decision making of family physicians and other primary care clinicians, and developing reimbursement models to sustain family medicine and primary care practices. The leadership of US family medicine organizations is committed to a transformative process. In partnership with others, this process has the potential to integrate health care to improve the health of all Americans.

Pain Medicines and Kidney Damage

MedlinePlus

... Process Research Training & Career Development Funded Grants & Grant History Research Resources Research at NIDDK Technology Advancement & Transfer Meetings & Workshops Health Information Diabetes Digestive ...

Using OpenEHR in SICTI an electronic health record system for critical medicine

NASA Astrophysics Data System (ADS)

Filgueira, R.; Odriazola, A.; Simini, F.

2007-11-01

SICTI is a software tool for registering health records in critical medicine environments. Version 1.0 has been in use since 2003. The Biomedical Engineering Group (Núcleo de Ingeniería Biomédica), with support from the Technological Development Programme (Programa de Desarrollo Tecnológico), decided to develop a new version, to provide an aid for more critical medicine processes, based on a framework which would make the application domain change oriented. The team analyzed three alternatives: to develop an original product based on new research, to base the development on OpenEHR framework, or to use HL7 RIM as the reference model for SICTI. The team opted for OpenEHR. This work describes the use of OpenEHR, its strong and weak points, and states future work perspectives.

Flood replenishment: a new method of processor control.

PubMed

Frank, E D; Gray, J E; Wilken, D A

1980-01-01

In mechanized radiographic film processors that process medium to low volumes of film, roll films, and those that process single-emulsion films from nuclear medicine scans, computed tomography, and ultrasound, it is difficult to maintain the developer solution at a stable processing level. We describe our experience using flood replenishment, which is a method in which developer replenisher containing starter solution is introduced in the processor at timed intervals, independent of the number of films being processed. By this process, a stable level of developer activity is maintained in a processor used to develop a medium to low volume of single-emulsion film.

The impact of the improvement in internal medicine consultation process on ED length of stay.

PubMed

Shin, Sangheon; Lee, Soo Hoon; Kim, Dong Hoon; Kim, Seong Chun; Kim, Tae Yun; Kang, Changwoo; Jeong, Jin Hee; Lim, Daesung; Park, Yong Joo; Lee, Sang Bong

2018-04-01

Although consultations are essential for delivering safe, high-quality care to patients in emergency departments, they contribute to emergency department patient flow problems and overcrowding which is associated with several adverse outcomes, such as increases in patient mortality and poor quality care. This study aimed to investigate how time flow metrics including emergency department length of stay is influenced by changes to the internal medicine consultation policy. This study is a pre- and post-controlled interventional study. We attempted to improve the internal medicine consultation process to be more concise. After the intervention, only attending emergency physicians consult internal medicine chief residents, clinical fellows, or junior staff of each internal medicine subspecialty who were on duty when patients required special care or an admission to internal medicine. Emergency department length of stay of patients admitted to the department of internal medicine prior to and after the intervention decreased from 996.94min to 706.62min. The times from consultation order to admission order and admission order to emergency department departure prior to and after the intervention were decreased from 359.59min to 180.38min and from 481.89min to 362.37min, respectively. The inpatient mortality rates and Inpatient bed occupancy rates prior to and after the intervention were similar. The improvements in the internal medicine consultation process affected the flow time metrics. Therefore, more comprehensive and cooperative strategies need to be developed to reduce the time cycle metrics and overcrowding of all patients in the emergency department. Copyright © 2017 Elsevier Inc. All rights reserved.

[The Innovation Office of the Paul-Ehrlich-Institut. Regulatory support during the scientific development of ATMP].

PubMed

Ziegele, B; Dahl, L; Müller, A T

2011-07-01

In conformity with Regulation (EC) No. 1394/2007, advanced therapy medicinal products (ATMP) are now subject to the centralized marketing authorization procedure. This also applies to most medicinal products in regenerative medicine. ATMP that have been marketed in a member state by the end of 2008 must be centrally authorized by the end of 2012 at the latest. In exceptional cases, a national authorization is acceptable. Developers of these medicinal products are usually academic institutions or small- and medium-sized enterprises (SME). They focus on scientific aspects and usually have little experience with pharmaceutical law. The Innovation Office of the Paul-Ehrlich-Institut (PEI) is designed to support developers of medicinal products in the areas between research and development, on the one hand, and regulatory requirements, on the other. Its main role is supportive advice in the regulatory field with an emphasis on ATMP. For this purpose, the Innovation Office makes use of core competences from various experts at the PEI in order to provide a quality consulting service to those companies who are seeking advice as early as possible and hand in hand with the development process. The aim is to support the developer to identify the appropriate regulatory pathway and to provide advice for each individual medicinal product at its corresponding stage of development in order to develop a high-quality ATMP manufactured on the basis of positive nonclinical results and appropriate clinical studies that meet all the necessary requirements for the application of a marketing authorization.

Creating Entrustable Professional Activities to Assess Internal Medicine Residents in Training: A Mixed-Methods Approach.

PubMed

Taylor, David R; Park, Yoon Soo; Smith, Christopher A; Karpinski, Jolanta; Coke, William; Tekian, Ara

2018-05-15

Competency-based medical education has not advanced residency training as much as many observers expected. Some medical educators now advocate reorienting competency-based approaches to focus on a resident's ability to do authentic clinical work. To develop descriptions of clinical work for which internal medicine residents must gain proficiency to deliver meaningful patient care (for example, "Admit and manage a medical inpatient with a new acute problem"). A modified Delphi process involving clinical experts followed by a conference of educational experts. The Royal College of Physicians and Surgeons of Canada. In phase 1 of the project, members of the Specialty Committee for Internal Medicine participated in a modified Delphi process to identify activities in internal medicine that represent the scope of the specialty. In phase 2 of the project, 5 experts who were scholars and leaders in competency-based medical education reviewed the results. Phase 1 identified important activities, revised descriptions to improve accuracy and avoid overlap, and assigned activities to stages of training. Phase 2 compared proposed activity descriptions with published guidelines for their development and application in medical education. The project identified 29 activities that qualify as entrustable professional activities. The project also produced a detailed description of each activity and guidelines for using them to assess residents. These activities reflect the practice patterns of the developers and may not fully represent internal medicine practice in Canada. Identification of these activities is expected to facilitate modification of training and assessment programs for medical residents so that programs focus less on isolated skills and more on integrated tasks. Southeastern Ontario Academic Medical Organization Endowed Scholarship and Education Fund and Queen's University Department of Medicine Innovation Fund.

A Qualitative Study of the Communication Process for Medical Acupuncture in Family Medicine.

PubMed

Ledford, Christy J W; Fisher, Carla L; Crawford, Paul

2018-05-01

As evidence establishes the efficacy of medical acupuncture, more family physicians and family medicine residents may receive medical acupuncture training and need to know how to effectively communicate about the treatment option with patients. By identifying how physicians talk about acupuncture treatment with their patients, we aimed to develop a model for physician training that could enhance their ability to integrate and practice medical acupuncture in conventional clinical settings. To capture the communication process that family physicians engage in when integrating acupuncture treatment into a clinical environment, we sought both physicians' and patients' perspectives. We conducted interviews with 17 family physicians and 15 patients in a US family medicine clinic that has integrated medical acupuncture into its practice. Audio recordings were transcribed and analyzed by two members of the study team in ATLAS.ti, using the constant comparative method. Integrating acupuncture into family medicine entailed a three-phase communication process: (1) introduce acupuncture, (2) explain the medical process, and (3) evaluate treatment outcomes. The emerging three-phase process of communicating acupuncture described here provides an initial model for teaching communication in the context of medical acupuncture. Given the exploratory nature of this initial study and the rarity of acupuncture treatment integrated into family medical settings, this is a first step in building knowledge in this realm of practice. Future research is needed to better understand the experience of patients who do not report notable results of acupuncture and to extend this study into other family medicine settings.

3D Printing Pharmaceuticals: Drug Development to Frontline Care.

PubMed

Trenfield, Sarah J; Awad, Atheer; Goyanes, Alvaro; Gaisford, Simon; Basit, Abdul W

2018-05-01

3D printing (3DP) is forecast to be a highly revolutionary technology within the pharmaceutical sector. In particular, the main benefits of 3DP lie in the production of small batches of medicines, each with tailored dosages, shapes, sizes and release characteristics. The manufacture of medicines in this way may finally lead to the concept of personalised medicines becoming a reality. In the shorter term, 3DP could be extended throughout the drug development process, ranging from preclinical development and clinical trials, through to frontline medical care. In this review, we provide a timely perspective on the motivations and potential applications of 3DP pharmaceuticals, as well as a practical viewpoint on how 3DP could be integrated across the pharmaceutical space. Copyright © 2018 Elsevier Ltd. All rights reserved.

The emergence of family medicine in Kyrgyzstan.

PubMed

Hardison, Charles; Fonken, Paul; Chew, Tom; Smith, Barton

2007-10-01

In post-Soviet Central Asia, Kyrgyzstan has emerged as the leader in family medicine reform. This paper examines the factors that have allowed family medicine to become the foundation of primary care and the rationale for retraining specialists in primary care. Critical elements of successful family medicine reform have included national policy, international cooperation, training programs, support structures, and quality measures. The national policy has contributed to an environment that has allowed many international organizations to participate in the process of reforming the health care system. The 9-year training process was a momentous nationwide development task that was supported by various structures, organizations, and events and included the implementation of quality measures. Various reports, studies, and evaluations support the positive impact family medicine has had on patient satisfaction, physician attitude, and scope of practice. Further, one study indicates improved health outcomes in terms of decreased years of potential life lost. The national policy of reform that is in favor of family medicine, and international donor agencies-supported training, produced the following results: a group of family medicine teachers, 98% (2,691) of the country's primary care doctors retrained in family medicine, and there were 372 family medicine resident graduates. To ensure quality, objective structured clinical exams were implemented in all levels of training. It will take many more years to fully establish family medicine in the medical culture of Kyrgyzstan and reap its full benefits, but already it is contributing toward improvements in the quality of patient care.

Investigation of the Effect of Rice Wine on the Metabolites of the Main Components of Herbal Medicine in Rat Urine by Ultrahigh-Performance Liquid Chromatography-Quadrupole/Time-of-Flight Mass Spectrometry: A Case Study on Cornus officinalis.

PubMed

Cao, Gang; Cai, Hao; Yue, Xianke; Tu, Sicong; Cai, Baochang; Xu, Zhiwei

2013-01-01

Ultrahigh-performance liquid chromatography-quadrupole/time-of-flight mass spectrometry (UPLC-QTOF/MS) was developed for rapid and sensitive analysis of the effect of rice wine on the metabolites of the main components of herbal medicine in rat urine. Using Cornus officinalis as a model of herbal medicine, the metabolite profiles of crude and processed (steaming the crude drug presteeped in rice wine) Cornus officinalis extracts in rat urine were investigated. The metabolites of Cornus officinalis were identified by using dynamic adjustment of the fragmentor voltage to produce structure-relevant fragment ions. In this work, we identified the parent compounds and metabolites of crude and processed Cornus officinalis in rats. In total, three parent compounds and seventeen new metabolites of Cornus officinalis were found in rats. The contents of the parent compounds and metabolites in vivo varied significantly after intragastric (i.g.) administration of aqueous extracts of crude and processed Cornus officinalis. Data from this study suggests that UPLC-QTOF/MS could be used as a potential tool for uncovering the effects of excipients found in the metabolites of the main components of herbal medicine, in vivo, to predict and discover the processing mechanisms of herbal medicine.

Description and Early Outcomes of a Comprehensive Curriculum Redesign at the Northwestern University Feinberg School of Medicine.

PubMed

Heiman, Heather L; O'Brien, Celia L; Curry, Raymond H; Green, Marianne M; Baker, James F; Kushner, Robert F; Thomas, John X; Corbridge, Thomas C; Corcoran, Julia F; Hauser, Joshua M; Garcia, Patricia M

2017-09-26

In 2012, the Northwestern University Feinberg School of Medicine launched a redesigned curriculum addressing the four primary recommendations in the 2010 Carnegie Foundation for the Advancement of Teaching report on reforming medical education. This new curriculum provides a more standardized evaluation of students' competency achievement through a robust portfolio review process coupled with standard evaluations of medical knowledge and clinical skills. It individualizes learning processes through curriculum flexibility, enabling students to take electives earlier and complete clerkships in their preferred order. The new curriculum is integrated both horizontally and vertically, combining disciplines within organ-based modules and deliberately linking elements (science in medicine, clinical medicine, health and society, professional development) and threads (medical decision making, quality and safety, teamwork and leadership, lifestyle medicine, advocacy and equity) across the three phases that replaced the traditional four-year timeline. It encourages students to conduct research in an area of interest and commit to lifelong learning and self-improvement. The curriculum formalizes the process of professional identity formation and requires students to reflect on their experiences with the informal and hidden curricula, which strongly shape their identities.The authors describe the new curriculum structure, explain their approach to each Carnegie report recommendation, describe early outcomes and challenges, and propose areas for further work. Early data from the first cohort to progress through the curriculum show unchanged United States Medical Licensing Examination Step 1 and 2 scores, enhanced student research engagement and career exploration, and improved student confidence in the patient care and professional development domains.

Historical Roots of International Biomedical and Health Informatics: The Road to IFIP-TC4 and IMIA through Cybernetic Medicine and the Elsinore Meetings.

PubMed

Kulikowski, C A

2017-08-01

Background: It is 50 years since the International Federation of Information Processing (IFIP) Societies approved the formation of a new Technical Committee (TC) 4 on Medical Information Processing under the leadership of Professor Francois Grémy, which was the direct precursor of the International Medical Informatics Association (IMIA). Objectives: The goals of this paper are to give a very brief overview of early international developments leading to informatics in medicine, with the origins of the applications of computers to medicine in the USA and Europe, and two meetings - of the International Society of Cybernetic Medicine, and the Elsinore Meetings on Hospital Information Systems-that took place in 1966. These set the stage for the formation of IFIP-TC4 the following year, with later sponsorship of the first MEDINFO in 1974, setting the path for the evolution to IMIA. Methods: This paper reviews and analyzes some of the earliest research and publications, together with two critical contrasting meetings in 1966 involving international activities in what evolved into biomedical and health informatics in terms of their probable influence on the formation of IFIP-TC4. Conclusion: The formation of IFIP-TC 4 in 1967 by Francois Grémy arose out of his concerns for merging, at an international level, the diverse strands from the more abstract work on cybernetic medicine and its basis in biophysical and neural modeling, with the more concrete and health-oriented medical information processing that was developing at the time for hospitals and clinical decision-making. Georg Thieme Verlag KG Stuttgart.

Developing translational medicine professionals: the Marie Skłodowska-Curie action model.

PubMed

Petrelli, Alessandra; Prakken, Berent J; Rosenblum, Norman D

2016-11-29

End goal of translational medicine is to combine disciplines and expertise to eventually promote improvement of the global healthcare system by delivering effective therapies to individuals and society. Well-trained experts of the translational medicine process endowed with profound knowledge of biomedical technology, ethical and clinical issues, as well as leadership and teamwork abilities are essential for the effective development of tangible therapeutic products for patients. In this article we focus on education and, in particular, we discuss how programs providing training on the broad spectrum of the translational medicine continuum have still a limited degree of diffusion and do not provide professional support and mentorship in the long-term, resulting in the lack of well established professionals of translational medicine (TMPs) in the scientific community. Here, we describe the Marie Skłodowska-Curie Actions program ITN-EUtrain (EUropean Translational tRaining for Autoimmunity & Immune manipulation Network) where training on the Translational Medicine machinery was integrated with education on professional and personal skills, mentoring, and a long-lasting network of TMPs.

[How to adapt to the requirements of "clinical value-oriented drug innovation" for pharmaceutical research in application process of new traditional Chinese medicine].

PubMed

Jin, Fang

2017-05-01

On August 9, 2015, the State Council promulgated the "Opinions of the State Council on the reform of drug and medical device review and approval system" (Guofa 2015 No. 44), and established the "clinical value-oriented drug innovation" model to encourage the research and development of new drugs. Following that, China Food and Drug Administration (CFDA) promulgated the "Notice on several policies for drug registration review and approval" (2015 No. 230 ) on November 11, 2015, clearly specifying that CFDA would "implement one-time approval for clinical trials application of the new drugs, and no longer take a phased declaration, review and approval system; for the new drugs that apply for clinical trials, mainly review the scientific natureof the clinical protocols and the risk control of the new drugs to guarantee the safety of subjects". Accordingly, the evaluation ideas and forms of new drug registration have also been adjusted greatly. For example, issues like the rationality of the drug manufacturing process, whether the scale can reflect the stability of the process, whether the preparation process is sufficient, and whether the choice of dosage form is reasonable are no longer the focus of evaluation before clinical trials. Issues regarding whether the preparation process design is reasonable, whether the effective components can be transferred to the preparation to a maximum extent, whether the process parameters determined in small and middle pilot trials can adapt to the requirements of mass production, no longer act as the reasons for refusing the clinical trials. The corresponding risks shall be borne by the applicant as the subject of liability. The focus in registration evaluation is mainly transferred to how to ensure the consistence of quality between clinical trial samples and the samples already available on market by guaranteeing stable sources of drug raw materials and stable quality of medicines as well as control of the whole preparation process. These issues run through the whole process of new drug development, but also have different focuses in different stages. According to the "Measures on communicating about drug research and development and technical review" (2016 No. 94) (On Trial) issued by CFDA on June 2, 2016, the applicants may communicate with the drug evaluation center in different phases in the process of new drugs registration in respects of medicine material problems, technological problems, and quality control of the preparations. In this paper, the transformation of Chinese medicine research model was described mainly in the following aspects: how to control the quality of medicines from origins, technology design of the preparation and technology process research, and how to establish whole-process quality system. The paper also reflects the concept that the quality of new Chinese drugs research and development comes from design. Copyright© by the Chinese Pharmaceutical Association.

[Establishment of traceability system of Chinese medicinal materials' quality].

PubMed

Qi, Yao-dong; Gao, Shi-man; Liu, Hai-tao; Li, Xi-wen; Wei, Jian-he; Zhang, Ben-gang; Sun, Xiao-bo; Xiao, Pei-gen

2015-12-01

The quality of Chinese medicinal materials relates greatly to the clinical curative effect and security. In order to ensure the quality and safety of Chinese medicinal materials, a systematic and operable traceability system needs to be established. It can realize the whole process of quality and safety management of Chinese medicinal materials "from production to consumption" through recording and inquiring information and recalling defective products, which is an important direction for the future development of traditional Chinese medicine. But it is still at the exploration and trial stage. In this paper, a framework of Chinese medicinal materials' quality and safety traceability system was established on the basis of the domestic and international experience about the construction of food and agricultural products traceability systems. The relationship between traceability system of Chinese medicinal materials' quality and GAP, GMP, GSP was analyzed, and the possible problems and the corresponding solutions were discussed.

Personalized medicine. Closing the gap between knowledge and clinical practice.

PubMed

Anaya, Juan-Manuel; Duarte-Rey, Carolina; Sarmiento-Monroy, Juan C; Bardey, David; Castiblanco, John; Rojas-Villarraga, Adriana

2016-08-01

Personalized medicine encompasses a broad and evolving field informed by a patient distinctive information and biomarker profile. Although terminology is evolving and some semantic interpretations exist (e.g., personalized, individualized, precision), in a broad sense personalized medicine can be coined as: "To practice medicine as it once used to be in the past using the current biotechnological tools." A humanized approach to personalized medicine would offer the possibility of exploiting systems biology and its concept of P5 medicine, where predictive factors for developing a disease should be examined within populations in order to establish preventive measures on at-risk individuals, for whom healthcare should be personalized and participatory. Herein, the process of personalized medicine is presented together with the options that can be offered in health care systems with limited resources for diseases like rheumatoid arthritis and type 1 diabetes. Copyright © 2016 Elsevier B.V. All rights reserved.

Information technology - a tool for development of the teaching process at the faculty of medicine, university of sarajevo.

PubMed

Masic, Izet; Begic, Edin

2015-04-01

Information Technologies, taking slow steps, have found its application in the teaching process of Faculty of Medicine, University of Sarajevo. Online availability of the teaching content is mainly intended for users of the Bologna process. The aim was to present the level of use of information technologies at the Faculty of Medicine, University of Sarajevo, comparing two systems, old system and the Bologna process, and to present new ways of improving the teaching process, using information technology. The study included the period from 2012 to 2014, and included 365 students from the old system and the Bologna Process. Study had prospective character. Students of the old system are older than students of the Bologna process. In both systems higher number of female students is significantly present. All students have their own computers, usually using the Office software package and web browsers. Visits of social networks were the most common reason for which they used computers. On question if they know to work with databases, 14.6% of students of the old system responded positively and 26.2% of students of the Bologna process answered the same. Students feel that working with databases is necessary to work in primary health care. On the question of the degree of computerization at the university, there were significant differences between the two systems (p <0.05). When asked about the possibility of using computers at school, there were no significant differences between the two systems. There has been progress of that opportunity from year to year. Students of Bologna process were more interested in the introduction of information technology, than students of old system. 68.7% of students of the Bologna process of generation 2013-2014, and 71.3% of generation 2014-2015, believed that the subject of Medical Informatics, the same or similar name, should be included in the new reform teaching process of the Faculty of Medicine, University of Sarajevo. Information technologies can help the development of the teaching process, and represent attractive and accessible tool in the process of modernization and progress.

Family medicine practice performance and knowledge management.

PubMed

Orzano, A John; McInerney, Claire R; Tallia, Alfred F; Scharf, Davida; Crabtree, Benjamin F

2008-01-01

Knowledge management (KM) is the process by which people in organizations find, share, and develop knowledge for action. KM affects performance by influencing work relationships to enhance learning and decision making. To identify how family medicine practices exhibit KM. A model and a template of KM concepts were derived from a comprehensive organizational literature review. Two higher and two lower performing family medicine practices were purposefully selected from existing comparative case studies based on prevention delivery rates and innovation. Interviews, fieldnotes of operations, and clinical encounters were coded independently using the template. Face-to-face discussions resolved coding differences. All practices had processes and tools for finding, sharing, and developing knowledge; however, KM overall was limited despite implementation of expensive technologies like an electronic medical record. Where present, KM processes and tools were used by individuals but not integrated throughout the organization. Loss of information was prominent, and finding knowledge was underdeveloped. The use of technical tools and developing knowledge by reconfiguration and measurement were particularly limited. Socially related tools, such as face-to-face-communication for sharing and developing knowledge, were more developed. As in other organizations, tool use was tailored for specific outcomes and leveraged by other organizational capacities. Differences in KM occur within family practices and between family practices and other organizations and may have implications for improving practice performance. Understanding interaction patterns of work relationships and KM may explain why costly technical or externally imposed "one size fits all" practice organizational interventions have had mixed results and limited sustainability.

[AT THE CROSSROADS: THE ROLE OF LABORATORY MEDICINE IN THE PATIENT CARE PROCESS].

PubMed

Geffen, Yuval; Zaidise, Itzhak

2017-06-01

In recent decades, the laboratory medicine profession has undergone significant changes due to both technological developments and economic constraints. Technological innovations support automation, provide faster and more accurate equipment, and allow increased efficiency through the use of commercial test kits. These changes, combined with budgetary constraints, have led to mergers and centralization of medical laboratories to optimize work and cut costs. While this centralization may be a business necessity, it leads to a disconnection between the laboratory and the clinical context. In addition, laboratory tests are treated as a commodity, which places emphasis on price only, rather than quality. In this article, we review the developments and changes that medical laboratories and the laboratory medicine profession have undergone in recent decades. We focus on technological and structural challenges affecting the functioning of medical laboratories and the relations between laboratory workers and medical teams. We then introduce vocational education changes required for the laboratory medicine profession. We propose defining the role of medical laboratory directors in terms of their basic training as medical doctors or doctors of science. We suggest that laboratory employees should become a reliable source of information regarding selection of appropriate test methods, processing data and presenting the results to the medical staff. Laboratory workers must deepen their clinical knowledge and become an integral part of the patient care process, along with medical and nursing staff. Special training programs for medical laboratory workers and directors must be developed in order to match the complex activities currently being conducted in laboratories.

Using a Delphi process to establish consensus on emergency medicine clerkship competencies.

PubMed

Penciner, Rick; Langhan, Trevor; Lee, Richard; McEwen, Jill; Woods, Robert A; Bandiera, Glen

2011-01-01

Currently, there is no consensus on the core competencies required for emergency medicine (EM) clerkships in Canada. Existing EM curricula have been developed through informal consensus or local efforts. The Delphi process has been used extensively as a means for establishing consensus. The purpose of this project was to define core competencies for EM clerkships in Canada, to validate a Delphi process in the context of national curriculum development, and to demonstrate the adoption of the CanMEDS physician competency paradigm in the undergraduate medical education realm. Using a modified Delphi process, we developed a consensus amongst a panel of expert emergency physicians from across Canada utilizing the CanMEDS 2005 Physician Competency Framework. Thirty experts from nine different medical schools across Canada participated on the panel. The initial list consisted of 152 competencies organized in the seven domains of the CanMEDS 2005 Physician Competency Framework. After the second round of the Delphi process, the list of competencies was reduced to 62 (59% reduction). This study demonstrated that a modified Delphi process can result in a strong consensus around a realistic number of core competencies for EM clerkships. We propose that such a method could be used by other medical specialties and health professions to develop rotation-specific core competencies.

Development of a nationwide consensus syllabus of palliative medicine for undergraduate medical education in Japan: a modified Delphi method.

PubMed

Kizawa, Yoshiyuki; Tsuneto, Satoru; Tamba, Kaichiro; Takamiya, Yusuke; Morita, Tatsuya; Bito, Seiji; Otaki, Junji

2012-07-01

There is currently no consensus syllabus of palliative medicine for undergraduate medical education in Japan, although the Cancer Control Act proposed in 2007 covers the dissemination of palliative care. To develop a nationwide consensus syllabus of palliative medicine for undergraduate medical education in Japan using a modified Delphi method. We adopted the following three-step method: (1) a workshop to produce the draft syllabus; (2) a survey-based provisional syllabus; (3) Delphi rounds and a panel meeting (modified Delphi method) to produce the working syllabus. Educators in charge of palliative medicine from 63% of the medical schools in Japan collaborated to develop a survey-based provisional syllabus before the Delphi rounds. A panel of 32 people was then formed for the modified Delphi rounds comprising 28 educators and experts in palliative medicine, one cancer survivor, one bereaved family member, and two medical students. The final consensus syllabus consists of 115 learning objectives across seven sections as follows: basic principles; disease process and comprehensive assessment; symptom management; psychosocial care; cultural, religious, and spiritual issues; ethical issues; and legal frameworks. Learning objectives were categorized as essential or desirable (essential: 66; desirable: 49). A consensus syllabus of palliative medicine for undergraduate medical education was developed using a clear and innovative methodology. The final consensus syllabus will be made available for further dissemination of palliative care education throughout the country.

New trends and challenges in the European regulation of innovative medicines.

PubMed

Enzmann, Harald

2016-10-01

Regulators' marketing authorizations for innovative medicines are linked into a complex process with successive crucial decisions. Objectives and decision criteria of the stakeholders in this process, e.g. health technology assessment (HTA) bodies, payers, physicians and patients, vary and may result not only in different but even mutually exclusive requirements. Reacting to changes in scientific, economic and social demands, European regulatory agencies alter content and format of their assessment procedures and their communication. New diagnostic options (e.g. genotyping and biomarkers) and pharmaceutical innovations (e.g. targeted medicines, nanomedicines) are the scientific drivers of this development. Social drivers are the price and reimbursement decisions by HTA bodies and payers, prerequisites for most patients' access to innovative medicines. The European Medicines Agency's adaptive licensing concept and priority medicines scheme foster the early authorization of innovative medicines. HTA builds on regulators' assessment, with additional requirements and economic components. An intensified exchange between all stakeholders, e.g. in multilateral scientific advice procedures has been initiated. Diminishing the differences in the requirements of regulators and HTA bodies is in the best interest of both patients and the pharmaceutical industry, avoiding duplication of work and accelerating patients' access by early decisions on price and reimbursement. Copyright © 2016 Elsevier Inc. All rights reserved.

The Future of Family Medicine: A Collaborative Project of the Family Medicine Community

PubMed Central

2004-01-01

BACKGROUND Recognizing fundamental flaws in the fragmented US health care systems and the potential of an integrative, generalist approach, the leadership of 7 national family medicine organizations initiated the Future of Family Medicine (FFM) project in 2002. The goal of the project was to develop a strategy to transform and renew the discipline of family medicine to meet the needs of patients in a changing health care environment. METHODS A national research study was conducted by independent research firms. Interviews and focus groups identified key issues for diverse constituencies, including patients, payers, residents, students, family physicians, and other clinicians. Subsequently, interviews were conducted with nationally representative samples of 9 key constituencies. Based in part on these data, 5 task forces addressed key issues to meet the project goal. A Project Leadership Committee synthesized the task force reports into the report presented here. RESULTS The project identified core values, a New Model of practice, and a process for development, research, education, partnership, and change with great potential to transform the ability of family medicine to improve the health and health care of the nation. The proposed New Model of practice has the following characteristics: a patient-centered team approach; elimination of barriers to access; advanced information systems, including an electronic health record; redesigned, more functional offices; a focus on quality and outcomes; and enhanced practice finance. A unified communications strategy will be developed to promote the New Model of family medicine to multiple audiences. The study concluded that the discipline needs to oversee the training of family physicians who are committed to excellence, steeped in the core values of the discipline, competent to provide family medicine’s basket of services within the New Model, and capable of adapting to varying patient needs and changing care technologies. Family medicine education must continue to include training in maternity care, the care of hospitalized patients, community and population health, and culturally effective and proficient care. A comprehensive lifelong learning program for each family physician will support continuous personal, professional, and clinical practice assessment and improvement. Ultimately, systemwide changes will be needed to ensure high-quality health care for all Americans. Such changes include taking steps to ensure that every American has a personal medical home, promoting the use and reporting of quality measures to improve performance and service, advocating that every American have health care coverage for basic services and protection against extraordinary health care costs, advancing research that supports the clinical decision making of family physicians and other primary care clinicians, and developing reimbursement models to sustain family medicine and primary care practices. CONCLUSIONS The leadership of US family medicine organizations is committed to a transformative process. In partnership with others, this process has the potential to integrate health care to improve the health of all Americans. PMID:15080220

Regulation of Cell and Gene Therapy Medicinal Products in Taiwan.

PubMed

Lin, Yi-Chu; Wang, Po-Yu; Tsai, Shih-Chih; Lin, Chien-Liang; Tai, Hsuen-Yung; Lo, Chi-Fang; Wu, Shiow-Ing; Chiang, Yu-Mei; Liu, Li-Ling

2015-01-01

Owing to the rapid and mature development of emerging biotechnology in the fields of cell culture, cell preservation, and recombinant DNA technology, more and more cell or gene medicinal therapy products have been approved for marketing, to treat serious diseases which have been challenging to treat with current medical practice or medicine. This chapter will briefly introduce the Taiwan Food and Drug Administration (TFDA) and elaborate regulation of cell and gene therapy medicinal products in Taiwan, including regulatory history evolution, current regulatory framework, application and review procedures, and relevant jurisdictional issues. Under the promise of quality, safety, and efficacy of medicinal products, it is expected the regulation and environment will be more flexible, streamlining the process of the marketing approval of new emerging cell or gene therapy medicinal products and providing diverse treatment options for physicians and patients.

[Award of the Salomon-Neumann-Medal 2017 - Speech of the Laureate Prof. Bernt-Peter Robra, 5 September 2017, St. Peter´s Church Lübeck].

PubMed

Robra, Bernt-Peter

2018-02-19

The Salomon-Neumann-Medal 2017 of the German Society for Social Medicine and Prevention (DGSMP) was awarded to Bernt-Peter Robra, Institute for Social Medicine and Health Economics (ISMG) of the Otto von Guericke University Magdeburg. The person and scientific merits of Manfred Pflanz are valued and topics of the masterplan2020-process are highlighted, that offer chances for developments in medicine and public health. © Georg Thieme Verlag KG Stuttgart · New York.

The development of a mandatory medical thesis in an urban medical school.

PubMed

Ogunyemi, Dotun; Bazargan, Mohsen; Norris, Keith; Jones-Quaidoo, Sean; Wolf, Kenneth; Edelstein, Ronald; Baker, Richard S; Calmes, Daphne

2005-01-01

The objective of this study was to describe the development of a primary care medical student's thesis. In 1995, as part of its primary care clerkship, the Charles R. Drew University of Medicine and Science (Drew University), College of Medicine created a curriculum requiring medical students to develop, design, and implement a research project during their 2-year longitudinal clinical experience. For this study, we reviewed all student research projects generated between 1995 and 2004. Among the 112 research projects, topics covered included internal medicine (29.5%), obstetrics and gynecology (OBGYN; 22%), psychosocial issues (20.5%), pediatrics (9%), public health/epidemiology (8%), medical education (8%), and surgery (3%). Mentors included faculty from internal medicine (16%), dean's office (16%), pediatrics (13%), family medicine (11%), non-Drew faculty (10%), OBGYN (9%), psychiatry (9%), surgery (9%), emergency medicine (4%), and pathology/radiology departments (3%). The students' survey showed that 83% agreed that the mentors were valuable, 72% admitted that their knowledge about the research process was improved, about 50% indicated that they were more competitive during residency application, and 80% claimed that they obtained satisfaction from accomplishing a goal. Students are able to conduct and present a primary care research project as a requirement of their medical training. Most students find the experience beneficial and positive.

Biomarker discovery and development in pediatric critical care medicine

PubMed Central

Kaplan, Jennifer M.; Wong, Hector R.

2010-01-01

Objective To frame the general process of biomarker discovery and development, and to describe a proposal for the development of a multi-biomarker based risk model for pediatric septic shock. Data Source Narrative literature review and author generated data. Main Results Biomarkers can be grouped into four broad classes, based on the intended function: diagnostic, monitoring, surrogate, and stratification. Biomarker discovery and development requires a rigorous process, which is frequently not well followed in the critical care medicine literature. Very few biomarkers have successfully transitioned from the candidate stage to the true biomarker stage. There is great interest in developing diagnostic and stratification biomarkers for sepsis. Procalcitonin is currently the most promising diagnostic biomarker for sepsis. Recent evidence suggests that interleukin-8 can be used to stratify children with septic shock having a high likelihood of survival with standard care. Currently, there is a multi-institutional effort to develop a multi-biomarker based sepsis risk model intended to predict outcome and illness severity for individual children with septic shock. Conclusions Biomarker discovery and development is an important portion of the pediatric critical care medicine translational research agenda. This effort will require collaboration across multiple institutions and investigators. Rigorous conduct of biomarker-focused research holds the promise of transforming our ability to care for individual patients and our ability to conduct clinical trials in a more effective manner. PMID:20473243

[Design and implementation of real-time control of changes to national Chinese medicine resources fill system based on GIS].

PubMed

Zhang, Tian; Li, Jun-de; Cheng, Meng; Li, Ying; Lin, Zhong-Bin; Shen, Yi-Hua; Huang, Lu-Qi

2017-11-01

The dynamic monitoring data of traditional Chinese medicine resources is one of the important tasks of the dynamic monitoring system of Chinese medicine resources,the system has formed a periodic monitoring data reporting mechanism. Data authenticity and accuracy are the basis for the sustainable and healthy development of Chinese medicine resources dynamic monitoring,information technology is an effective means to improve the efficiency of data reporting, reporting quality. Data production based on dynamic monitoring is of great significance for grasp the trend of change and development of Chinese medicine resources. In order to achieve the real-time control of changes to the national Chinese medicine resources, we build the Chinese medicine resources dynamic monitoring system. In order to solve the problems in practice, we have upgraded the fill system by using the data of GIS. In order to achieve the multidimensional, improve safety, practicality and standardization of the data, which laid a foundation for subsequent processing of data. The system can collect the information of the cultivation of Chinese herbal medicines,production and sales of daily reporting data, provide the Chinese herbal medicine market,fast growing industry environment such as positioning center. In this paper, the design and implementation of the system are expounded.According to the business requirements, we designed 12 forms, 98 collection indicators to meet the needs of dynamic monitoring of traditional Chinese medicine resources. This paper will introduce the development content, design and implementation, main function characteristics and application effect of the national Chinese medicine resources fill System. To explain the role that GIS technology plays in the system and how to realize the cultivation of Chinese herbal medicines, production and sales of daily reporting data, provide the Chinese herbal medicine market,fast growing industry environment such as positioning center,and information collecting. Copyright© by the Chinese Pharmaceutical Association.

The Development and Evolution of Physical Medicine and Rehabilitation in Taiwan from 1958 to 2016.

PubMed

Lien, I-Nan; Wu, Pei-Shen; Wang, Tyng-Guey; Chen, Ssu-Yuan; Lew, Henry L

2017-03-01

The field of physical medicine and rehabilitation (PM&R) began its development in Taiwan since 1958, and has gradually evolved into a profession that provides a diversity of clinical services and educational activities. The objectives of this brief report were to (1) review its background and milestones in the past 6 decades, (2) describe the current role and function of its Academy of PM&R, (3) present the content and format of its board certification process, focusing on (a) residency training requirements, (b) self-assessment examination, board certification process, and (c) maintenance of certification through continued education. Some challenges and opportunities are also discussed toward the end of this article. It is hoped that this report may serve as a reference material for other countries as they develop or improve their PM&R residency programs.

Stem cell therapy clinical research: A regulatory conundrum for academia.

PubMed

Nagpal, Anjali; Juttner, Chris; Hamilton-Bruce, Monica Anne; Rolan, Paul; Koblar, Simon A

2017-12-01

The encouraging pace of discovery and development in the field of regenerative medicine holds tremendous potential for bringing therapies to the clinic that may offer meaningful benefit to patients, particularly in diseases with no or suboptimal therapeutic options. Academic researchers will continue to play a critical role in developing concepts and therapies, thus determining whether regenerative medicine will be able to live up to this potential that clearly excites clinicians, researchers and patients alike. This review summarises recent developments in regulatory frameworks across different countries that aim to ensure adequate oversight of the development of regenerative medicine products, which are unique in structural and functional complexity when compared to traditional chemical drugs and fully characterised biological drugs. It discusses the implications of these developments for researchers aiming to make the challenging transition from laboratory to clinical development of these therapies and considers possible pragmatic solutions that could accelerate this process that is essential to maintain research credibility and ensure patient safety. Copyright © 2016 Elsevier B.V. All rights reserved.

An IT Architecture for Systems Medicine.

PubMed

Ganzinger, Matthias; Gietzelt, Matthias; Karmen, Christian; Firnkorn, Daniel; Knaup, Petra

2015-01-01

Systems medicine aims to support treatment of complex diseases like cancer by integrating all available data for the disease. To provide such a decision support in clinical practice, a suitable IT architecture is necessary. We suggest a generic architecture comprised of the following three layers: data representation, decision support, and user interface. For the systems medicine research project "Clinically-applicable, omics-based assessment of survival, side effects, and targets in multiple myeloma" (CLIOMMICS) we developed a concrete instance of the generic architecture. We use i2b2 for representing the harmonized data. Since no deterministic model exists for multiple myeloma we use case-based reasoning for decision support. For clinical practice, visualizations of the results must be intuitive and clear. At the same time, they must communicate the uncertainty immanent in stochastic processes. Thus, we develop a specific user interface for systems medicine based on the web portal software Liferay.

A Model Program for Translational Medicine in Epilepsy Genetics

PubMed Central

Smith, Lacey A.; Ullmann, Jeremy F. P.; Olson, Heather E.; El Achkar, Christelle M.; Truglio, Gessica; Kelly, McKenna; Rosen-Sheidley, Beth; Poduri, Annapurna

2017-01-01

Recent technological advances in gene sequencing have led to a rapid increase in gene discovery in epilepsy. However, the ability to assess pathogenicity of variants, provide functional analysis, and develop targeted therapies has not kept pace with rapid advances in sequencing technology. Thus, although clinical genetic testing may lead to a specific molecular diagnosis for some patients, test results often lead to more questions than answers. As the field begins to focus on therapeutic applications of genetic diagnoses using precision medicine, developing processes that offer more than equivocal test results is essential. The success of precision medicine in epilepsy relies on establishing a correct genetic diagnosis, analyzing functional consequences of genetic variants, screening potential therapeutics in the preclinical laboratory setting, and initiating targeted therapy trials for patients. We describe the structure of a comprehensive, pediatric Epilepsy Genetics Program that can serve as a model for translational medicine in epilepsy. PMID:28056630

Consensus Statement on Advancing Research in Emergency Department Operations and Its Impact on Patient Care

PubMed Central

Ward, Michael J.; Chang, Anna Marie; Pines, Jesse M.; Jouriles, Nick; Yealy, Donald M.

2016-01-01

The Consensus Conference on “Advancing Research in Emergency Department (ED) Operations and Its Impact on Patient Care,” hosted by The ED Operations Study Group (EDOSG), convened to craft a framework for future investigations in this important but underserved area. The EDOSG is a research consortium dedicated to promoting evidence based clinical practice in Emergency Medicine. The consensus process format was a modified version of the NIH Model for Consensus Conference Development. Recommendations provide an action plan for how to improve ED operations study design, create a facilitating research environment, identify data measures of value for process and outcomes research, and disseminate new knowledge in this area. Specifically, we called for eight key initiatives: 1) the development of universal measures for ED patient care processes; 2) attention to patient outcomes, in addition to process efficiency and best practice compliance; 3) the promotion of multi-site clinical operations studies to create more generalizable knowledge; 4) encouraging the use of mixed methods to understand the social community and human behavior factors that influence ED operations; 5) the creation of robust ED operations research registries to drive stronger evidence based research, 6) prioritizing key clinical questions with the input of patients, clinicians, medical leadership, emergency medicine organizations, payers, and other government stakeholders; 7) more consistently defining the functional components of the ED care system including observation units, fast tracks, waiting rooms, laboratories and radiology sub-units; and 8) maximizing multidisciplinary knowledge dissemination via emergency medicine, public health, general medicine, operations research and nontraditional publications. PMID:26014365

Quality transitivity and traceability system of herbal medicine products based on quality markers.

PubMed

Liu, Changxiao; Guo, De-An; Liu, Liang

2018-05-15

Due to a variety of factors to affect the herb quality, the existing quality management model is unable to evaluate the process control. The development of the concept of "quality marker" (Q-marker) lays basis for establishing an independent process quality control system for herbal products. To ensure the highest degree of safety, effectiveness and quality process control of herbal products, it is aimed to establish a quality transitivity and traceability system of quality and process control from raw materials to finished herbal products. Based on the key issues and challenges of quality assessment, the current status of quality and process controls from raw materials to herbal medicinal products listed in Pharmacopoeia were analyzed and the research models including discovery and identification of Q-markers, analysis and quality management of risk evaluation were designed. Authors introduced a few new technologies and methodologies, such as DNA barcoding, chromatographic technologies, fingerprint analysis, chemical markers, bio-responses, risk management and solution for quality process control. The quality and process control models for herbal medicinal products were proposed and the transitivity and traceability system from raw materials to the finished products was constructed to improve the herbal quality from the entire supply and production chain. The transitivity and traceability system has been established based on quality markers, especially on how to control the production process under Good Engineering Practices, as well as to implement the risk management for quality and process control in herbal medicine production. Copyright © 2018 Elsevier GmbH. All rights reserved.

Dietary Seaweed and Early Breast Cancer: A Randomized Trial

DTIC Science & Technology

2005-05-01

submitted to the American Journal of Clinical Nutrition . Our conclusions were that although 5 grams/day of seaweed, the average daily consumption in... Nutrition , Department of Medicine, Boston University School of Medicine, Boston, Massachusetts.4Process Development, Degussa Food Ingredients, Business Line... nutrition in Japan, a recommendation for increasing gious celebrations in precolonial times (23,24), and seaweeds seaweed consumption was included (17

An Alternative Methodological Approach for Cost-Effectiveness Analysis and Decision Making in Genomic Medicine.

PubMed

Fragoulakis, Vasilios; Mitropoulou, Christina; van Schaik, Ron H; Maniadakis, Nikolaos; Patrinos, George P

2016-05-01

Genomic Medicine aims to improve therapeutic interventions and diagnostics, the quality of life of patients, but also to rationalize healthcare costs. To reach this goal, careful assessment and identification of evidence gaps for public health genomics priorities are required so that a more efficient healthcare environment is created. Here, we propose a public health genomics-driven approach to adjust the classical healthcare decision making process with an alternative methodological approach of cost-effectiveness analysis, which is particularly helpful for genomic medicine interventions. By combining classical cost-effectiveness analysis with budget constraints, social preferences, and patient ethics, we demonstrate the application of this model, the Genome Economics Model (GEM), based on a previously reported genome-guided intervention from a developing country environment. The model and the attendant rationale provide a practical guide by which all major healthcare stakeholders could ensure the sustainability of funding for genome-guided interventions, their adoption and coverage by health insurance funds, and prioritization of Genomic Medicine research, development, and innovation, given the restriction of budgets, particularly in developing countries and low-income healthcare settings in developed countries. The implications of the GEM for the policy makers interested in Genomic Medicine and new health technology and innovation assessment are also discussed.

[The Yin and Yang movement in the cosmology of Chinese medicine].

PubMed

Coutinho, Bernardo Diniz; Dulcetti, Pérola Goretti Sichero

2015-01-01

After being developed in the East, based on Taoist cosmology, Chinese medicine has been practiced in the West based on scientific foundations and biomedical paradigms. Some traditional elements of this philosophy were abandoned, such as the theory of Yin and Yang, knowledge that is essential for understanding the health-disease process resulting from the circulation of the body's energy flow. This article studies the movement of the dual elements of Yin and Yang in Chinese medical teaching, seeking to understand how this line of thought developed and how it has contributed towards establishing a system of diagnosis and therapy. The methodology employed was to analyze literature on the subject, based on theoretical references to Taoist thought and traditional Chinese medicine.

A model of self-directed learning in internal medicine residency: a qualitative study using grounded theory.

PubMed

Sawatsky, Adam P; Ratelle, John T; Bonnes, Sara L; Egginton, Jason S; Beckman, Thomas J

2017-02-02

Existing theories of self-directed learning (SDL) have emphasized the importance of process, personal, and contextual factors. Previous medical education research has largely focused on the process of SDL. We explored the experience with and perception of SDL among internal medicine residents to gain understanding of the personal and contextual factors of SDL in graduate medical education. Using a constructivist grounded theory approach, we conducted 7 focus group interviews with 46 internal medicine residents at an academic medical center. We processed the data by using open coding and writing analytic memos. Team members organized open codes to create axial codes, which were applied to all transcripts. Guided by a previous model of SDL, we developed a theoretical model that was revised through constant comparison with new data as they were collected, and we refined the theory until it had adequate explanatory power and was appropriately grounded in the experiences of residents. We developed a theoretical model of SDL to explain the process, personal, and contextual factors affecting SDL during residency training. The process of SDL began with a trigger that uncovered a knowledge gap. Residents progressed to formulating learning objectives, using resources, applying knowledge, and evaluating learning. Personal factors included motivations, individual characteristics, and the change in approach to SDL over time. Contextual factors included the need for external guidance, the influence of residency program structure and culture, and the presence of contextual barriers. We developed a theoretical model of SDL in medical education that can be used to promote and assess resident SDL through understanding the process, person, and context of SDL.

[Development of whole process quality control and management system of traditional Chinese medicine decoction pieces based on traditional Chinese medicine quality tree].

PubMed

Yu, Wen-Kang; Dong, Ling; Pei, Wen-Xuan; Sun, Zhi-Rong; Dai, Jun-Dong; Wang, Yun

2017-12-01

The whole process quality control and management of traditional Chinese medicine (TCM) decoction pieces is a system engineering, involving the base environment, seeds and seedlings, harvesting, processing and other multiple steps, so the accurate identification of factors in TCM production process that may induce the quality risk, as well as reasonable quality control measures are very important. At present, the concept of quality risk is mainly concentrated in the aspects of management and regulations, etc. There is no comprehensive analysis on possible risks in the quality control process of TCM decoction pieces, or analysis summary of effective quality control schemes. A whole process quality control and management system for TCM decoction pieces based on TCM quality tree was proposed in this study. This system effectively combined the process analysis method of TCM quality tree with the quality risk management, and can help managers to make real-time decisions while realizing the whole process quality control of TCM. By providing personalized web interface, this system can realize user-oriented information feedback, and was convenient for users to predict, evaluate and control the quality of TCM. In the application process, the whole process quality control and management system of the TCM decoction pieces can identify the related quality factors such as base environment, cultivation and pieces processing, extend and modify the existing scientific workflow according to their own production conditions, and provide different enterprises with their own quality systems, to achieve the personalized service. As a new quality management model, this paper can provide reference for improving the quality of Chinese medicine production and quality standardization. Copyright© by the Chinese Pharmaceutical Association.

[Changes by Balint group education: experience with residents in family medicine].

PubMed

Laperrière, S; Turgeon, J

1993-09-01

The article is about the change observed in participants in a training course by the Balint groups. The authors' experiment is aimed at residents in family medicine. It involves both the psychiatrist and physician, leader and participant. Psychic functioning as a process is applied to presentation, discussions and leadership. The optimum clinical understanding of this training strives for development within the group itself. The authors consider two factors that come into play: symbolization and awareness. These concepts are developed to support the notion of a global approach.

Social Inclusion Through Para sport: A Critical Reflection on the Current State of Play.

PubMed

Bantjes, Jason; Swartz, Leslie

2018-05-01

Medicine has played an integral role in both the inception and development of the Paralympic Games. Sports physicians are well positioned to continue to influence the development of the paralympic movement and to help focus the movement on its agenda to promote social inclusion. This article looks critically at some of the key challenges that the paralympic movement faces in its quest to promote social inclusion, and considers the role of sports medicine in this process. Copyright © 2018 Elsevier Inc. All rights reserved.

[Summary of development in scientific researches of traditional Chinese medicine in twenty years（1996-2015）].

PubMed

2016-11-01

The modernization strategy of traditional Chinese medicine (TCM) has been implemented for 20 years. A great deal of basic and innovative researches have been done on basic theory of TCM, effective substance, efficacy evaluation, action mechanism, intracorporal metabolic process, safety evaluation, clinical evaluation and quality standards. As a result, a series of remarkable achievements in scientific research have been generated and promoted the interpretation of the connotation of TCM, supported the industry development of TCM and accelerated internationalization of TCM. Copyright© by the Chinese Pharmaceutical Association.

Balancing Between Aging and Cancer: Molecular Genetics Meets Traditional Chinese Medicine.

PubMed

Liu, Jing; Peng, Lei; Huang, Wenhui; Li, Zhiming; Pan, Jun; Sang, Lei; Lu, Siqian; Zhang, Jihong; Li, Wanyi; Luo, Ying

2017-09-01

The biological consequences of cellular senescence and immortalization in aging and cancer are in conflict. Organisms have developed common cellular signaling pathways and surveillance mechanisms to control the processing of aging against tumorigenesis. The imbalance of any signals involved in this process may result in either premature aging or tumorigenesis and reduce the life span of the organism. In contrast, the balance between aging and tumorigenesis at a higher level (homeostatic-balance) may benefit the organism with tumor-free longevity. The focus of this perspective is to review the literature on the balance between "Yin" and "Yang" in traditional Chinese medicine. Modern cellular and molecular techniques now permit a more robust system to screen herbs in traditional Chinese medicine for their activity in balancing aging and tumorigenesis. The understanding of the crosstalk between aging and tumorigenesis and new perspectives on the application of Chinese medicine might shed light on anti-aging and tumor-free strategies. J. Cell. Biochem. 118: 2581-2586, 2017. © 2017 Wiley Periodicals, Inc. © 2017 Wiley Periodicals, Inc.

Safety Surveillance of Traditional Chinese Medicine: Current and Future

PubMed Central

Liu, Shwu-Huey; Chuang, Wu-Chang; Lam, Wing; Jiang, Zaoli

2015-01-01

Herbal medicine, including traditional Chinese medicine, has been used for the prevention, treatment, and cure of disorders or diseases for centuries. In addition to being used directly as therapeutic agents, medicinal plants are also important sources for pharmacological drug research and development. With the increasing consumption of herbal products intended to promote better health, it is extremely important to assure the safety and quality of herbal preparations. However, under current regulation surveillance, herbal preparations may not meet expectations in safety, quality, and efficacy. The challenge is how to assure the safety and quality of herbal products for consumers. It is the responsibility of producers to minimize hazardous contamination and additives during cultivation, harvesting, handling, processing, storage, and distribution. This article reviews the current safety obstacles that have been involved in traditional Chinese herbal medicine preparations with examples of popular herbs. Approaches to improve the safety of traditional Chinese medicine are proposed. PMID:25647717

[Personalized medicine and individual healthcare : Medical and information technology aspects].

PubMed

Niederlag, W; Lemke, H U; Rienhoff, O

2010-08-01

The individualization of medicine and healthcare appears to be following a general societal trend. The terms "personalized medicine" and "personal health" are used to describe this process. Here it must be emphasized that personalized medicine is not limited to pharmacogenomics, but that the spectrum of personalized medicine is much broader. Applications range from individualized diagnostics, patient-specific pharmacological therapy, therapy with individual prostheses and implants to therapy approaches using autologous cells, and from patient model-based therapy in the operating room, electronic patient records through to the individual care of patients in their home environment with the use of technical systems and services. Although in some areas practical solutions have already been found, most applications will not be fully developed for many years to come. Medical and information technology are essential to personalized medicine and personal health, each driving the other forward.

Value added medicines: what value repurposed medicines might bring to society?

PubMed

Toumi, Mondher; Rémuzat, Cécile

2017-01-01

Background & objectives : Despite the wide interest surrounding drug repurposing, no common terminology has been yet agreed for these products and their full potential value is not always recognised and rewarded, creating a disincentive for further development. The objectives of the present study were to assess from a wide perspective which value drug repurposing might bring to society, but also to identify key obstacles for adoption of these medicines and to discuss policy recommendations. Methods : A preliminary comprehensive search was conducted to assess how the concept of drug repurposing was described in the literature. Following completion of the literature review, a primary research was conducted to get perspective of various stakeholders across EU member states on drug repurposing ( healthcare professionals, regulatory authorities and Health Technology Assessment (HTA) bodies/payers, patients, and representatives of the pharmaceutical industry developing medicines in this field). Ad hoc literature review was performed to illustrate, when appropriate, statements of the various stakeholders. Results : Various nomenclatures have been used to describe the concept of drug repurposing in the literature, with more or less broad definitions either based on outcomes, processes, or being a mix of both. In this context, Medicines for Europe (http://www.medicinesforeurope.com/value-added-medicines/) established one single terminology for these medicines, known as value added medicines, defined as 'medicines based on known molecules that address healthcare needs and deliver relevant improvements for patients, healthcare professionals and/or payers'. Stakeholder interviews highlighted three main potential benefits for value added medicines: (1) to address a number of medicine-related healthcare inefficiencies related to irrational use of medicines, non-availability of appropriate treatment options, shortage of mature products, geographical inequity in medicine access; (2) to improve healthcare system efficiency; and (3) to contribute to sustainability of healthcare systems through economic advantages. Current HTA framework, generic stigma, and pricing rules, such as internal reference pricing or tendering processes in place in some countries, were reported as the current key hurdles preventing the full recognition of value added medicines' benefits, discouraging manufacturers from bringing such products to the market. Discussion & conclusions : There is currently a gap between increasing regulatory authority interest in capturing value added medicines' benefits and the resistance of HTA bodies/payers, who tend to ignore this important segment of the pharmaceutical field. This situation calls for policy changes to foster appropriate incentives to enhance value recognition of value added medicines and deliver the expected benefit to society. Policy changes from HTA perspective should include: absence of any legislative barriers preventing companies from pursuing HTA; HTA requirements proportionate to potential reward; HTA decision-making framework taking into account the specific characteristics of value added medicines; eligibility for early HTA dialogues; Policy changes from pricing perspective should encompass: tenders/procurement policies allowing differentiation from generic medicines; eligibility for early entry agreement; non-systematic implementation of external and internal reference pricing policies; recognition of indication-specific pricing. At the same time, the pharmaceutical industry should engage all the stakeholders (patients, healthcare providers, HTA bodies/payers) in early dialogues to identify their expectations and to ensure the developed value added medicines address their needs.

Proposed correlation of modern processing principles for Ayurvedic herbal drug manufacturing: A systematic review.

PubMed

Jain, Rahi; Venkatasubramanian, Padma

2014-01-01

Quality Ayurvedic herbal medicines are potential, low-cost solutions for addressing contemporary healthcare needs of both Indian and global community. Correlating Ayurvedic herbal preparations with modern processing principles (MPPs) can help develop new and use appropriate technology for scaling up production of the medicines, which is necessary to meet the growing demand. Understanding the fundamental Ayurvedic principles behind formulation and processing is also important for improving the dosage forms. Even though Ayurvedic industry has adopted technologies from food, chemical and pharmaceutical industries, there is no systematic study to correlate the traditional and modern processing methods. This study is an attempt to provide a possible correlation between the Ayurvedic processing methods and MPPs. A systematic literature review was performed to identify the Ayurvedic processing methods by collecting information from English editions of classical Ayurveda texts on medicine preparation methods. Correlation between traditional and MPPs was done based on the techniques used in Ayurvedic drug processing. It was observed that in Ayurvedic medicine preparations there were two major types of processes, namely extraction, and separation. Extraction uses membrane rupturing and solute diffusion principles, while separation uses volatility, adsorption, and size-exclusion principles. The study provides systematic documentation of methods used in Ayurveda for herbal drug preparation along with its interpretation in terms of MPPs. This is the first step which can enable improving or replacing traditional techniques. New technologies or use of existing technologies can be used to improve the dosage forms and scaling up while maintaining the Ayurvedic principles similar to traditional techniques.

Empowerment of patients in online discussions about medicine use.

PubMed

van Berkel, Jasper J; Lambooij, Mattijs S; Hegger, Ingrid

2015-04-08

Patient empowerment is crucial in the successful self-management of people with chronic diseases. In this study, we investigated whether discussions about medicine use taking place on online message boards contribute to patient empowerment and could subsequently result in the more effective use of medicines. We discuss the extent to which patient empowerment processes occur in discussions on online message boards, focusing on patients with three disorders with different characteristics: diabetes, Amyotrophic Lateral Sclerosis (ALS) and Attention Deficit / Hyperactivity Disorder (ADHD). Because information is an important factor in both patient empowerment and self-management, we also evaluate the quality of the information being exchanged. We used a deductive thematic analysis method based on pre-existing categories. We gathered and analysed 5532 posts related to the conditions ADHD, ALS and diabetes from seven message boards (three for ADHD, three for diabetes, and one for ALS). We coded the posts for empowerment processes and the quality of the information exchanged. We identified patient empowerment processes in posts related to all three disorders. There is some variation in the frequency of these processes, but they show a similar order in the results: patients used the online message boards to exchange information, share personal experiences and for empathy or support. The type of information shared in these processes could contribute to the patient's self-efficacy when it comes to medicine use. The exchanged information was either correct or largely harmless. We also observed a tendency whereby participants correct previously posted incorrect information, and refer people to a healthcare professional following a request for medical advice, e.g. concerning the choice of medicines or dosage. Our findings show that patient empowerment processes occur in posts related to all three disorders. The type of information shared in these processes can contribute to the patient's self-efficacy when it comes to medicine use. The tendency to refer people to a healthcare professional shows that patients still reserve an important role for healthcare professionals in the care process, despite the development towards more self-management.

Development and 10-year history of a biosimilar: the example of Binocrit®

PubMed Central

Aapro, Matti; Krendyukov, Andriy; Höbel, Nadja; Seidl, Andreas; Gascón, Pere

2018-01-01

Patent expirations for several biological products have prompted the development of alternative versions, termed ‘biosimilars’, which have comparable quality, safety and efficacy to a licensed biological medicine (also referred to as the ‘reference’ medicine). The first biosimilars developed in oncology were the supportive-care agents filgrastim and epoetin. Binocrit® (HX575) is a biosimilar version of epoetin alfa, indicated in the oncology setting for the treatment of chemotherapy-induced anemia (CIA). The process for development and approval of Binocrit® as a biosimilar included extensive analytical characterization and comparison with the reference epoetin alfa. This was followed by a clinical development program comprising phase I pharmacokinetic/pharmacodynamic studies to show bioequivalence to the reference medicine and a confirmatory phase III study to confirm therapeutic effectiveness in CIA. Since its approval, Binocrit® has been extensively used and studied in real-world clinical practice. The accumulated data confirm that Binocrit® is an effective and well-tolerated option for the treatment of CIA in patients with cancer.

'It can do no harm': Body maintenance and modification in alternative medicine acknowledged as a non risk health regimen.

PubMed

Pedersen, Inge Kryger

2013-08-01

This article proposes the notion of a non-risk health regimen as a mode of recognising more dynamic aspects of risk-awareness in health care, in this case alternative medicine in Denmark. Danish users of alternative medicine are in an ambivalent position. They are responsible citizens who care about their own health. On the other hand, they are doing this by paying out of their own pockets for attending non-authorised treatments with very limited scientific evidence for their effects. This article draws on 138 qualitative in-depth interviews conducted in 2006-07 with 46 Danish users of different forms of session-based alternative medicine. A recurring theme throughout users' accounts is found to be that the treatments 'at least can do no harm'. Many of the users regard pharmaceuticals or surgery as an artificial impediment and a threat to overall health, whereas the energy-stimulating processes initiated by the alternative practitioner are not considered risky. The no harm discourse constitutes a sophisticated lay-explanation that brings together a wide range of explanations within which three themes are identified: responsibility; optimization; desperation. By informing these findings with the concept of reflexive body techniques, it is shown that use of alternative medicine is a process of working on the self and body in a spectrum between transition (i.e., pain relief or self-development) and continuity (i.e. well-being or prevention of illness) and not only a quest for cure. In this process 'non-risk' emerges as a lay explanation in the efforts of users to construct coherent self-narratives as agents in a risk-aware environment. The development of the notion of a non-risk health regimen invites and facilitates further studies on various lay motives within health care in general and contributes to explaining the popularity of alternative medicine in particular. Copyright © 2013 Elsevier Ltd. All rights reserved.

Toward a national core course in agricultural medicine and curriculum in agricultural safety and health: the "building capacity" consensus process.

PubMed

Rudolphi, Josie M; Donham, Kelley J

2015-01-01

ABSTRACT The agricultural industry poses specific hazards and risks to its workers. Since the 1970s, the University of Iowa has been establishing programs to educate rural health care and safety professionals who in turn provide education and occupational health and safety services to farm families and farm workers. This program has been well established in the state of Iowa as a program of Iowa's Center for Agricultural Safety and Health (I-CASH). However, the National 1989 Agriculture at Risk Report indicated there was a great need for agricultural medicine training beyond Iowa's borders. In order to help meet this need, Building Capacity: A National Resource of Agricultural Medicine Professionals was initiated as a project of the National Institute for Occupational Safety and Health (NIOSH)-funded Great Plains Center for Agricultural Health in 2006. Before the first phase of this project, a consensus process was conducted with a group of safety and health professionals to determine topics and learning objectives for the course. Over 300 students attended and matriculated the agricultural medicine course during first phase of the project (2007-2010). Beginning the second phase of the project (2012-2016), an expanded advisory committee (38 internationally recognized health and safety professionals) was convened to review the progress of the first phase, make recommendations for revisions to the required topics and competencies, and discuss updates to the second edition of the course textbook (Agricultural Medicine: Occupational and Environmental Health for the Health Professions). A formal consensus process was held and included an online survey and also a face-to-face meeting. The group was charged with the responsibility of developing the next version of this course by establishing best practices and setting an agenda with the long-term goal of developing a national course in agricultural medicine.

[A new strategy for Chinese medicine processing technologies: coupled with individuation processed and cybernetics].

PubMed

Zhang, Ding-kun; Yang, Ming; Han, Xue; Lin, Jun-zhi; Wang, Jia-bo; Xiao, Xiao-he

2015-08-01

The stable and controllable quality of decoction pieces is an important factor to ensure the efficacy of clinical medicine. Considering the dilemma that the existing standardization of processing mode cannot effectively eliminate the variability of quality raw ingredients, and ensure the stability between different batches, we first propose a new strategy for Chinese medicine processing technologies that coupled with individuation processed and cybernetics. In order to explain this thinking, an individual study case about different grades aconite is provided. We hope this strategy could better serve for clinical medicine, and promote the inheritance and innovation of Chinese medicine processing skills and theories.

Critical Care and Personalized or Precision Medicine: Who needs whom?

PubMed

Sugeir, Shihab; Naylor, Stephen

2018-02-01

The current paradigm of modern healthcare is a reactive response to patient symptoms, subsequent diagnosis and corresponding treatment of the specific disease(s). This approach is predicated on methodologies first espoused by the Cnidean School of Medicine approximately 2500years ago. More recently escalating healthcare costs and relatively poor disease treatment outcomes have fermented a rethink in how we carry out medical practices. This has led to the emergence of "P-Medicine" in the form of Personalized and Precision Medicine. The terms are used interchangeably, but in fact there are significant differences in the way they are implemented. The former relies on an "N-of-1" model whereas the latter uses a "1-in-N" model. Personalized Medicine is still in a fledgling and evolutionary phase and there has been much debate over its current status and future prospects. A confounding factor has been the sudden development of Precision Medicine, which has currently captured the imagination of policymakers responsible for modern healthcare systems. There is some confusion over the terms Personalized versus Precision Medicine. Here we attempt to define the key differences and working definitions of each P-Medicine approach, as well as a taxonomic relationship tree. Finally, we discuss the impact of Personalized and Precision Medicine on the practice of Critical Care Medicine (CCM). Practitioners of CCM have been participating in Personalized Medicine unknowingly as it takes the protocols of sepsis, mechanical ventilation, and daily awakening trials and applies it to each individual patient. However, the immediate next step for CCM should be an active development of Precision Medicine. This developmental process should break down the silos of modern medicine and create a multidisciplinary approach between clinicians and basic/translational scientists. Copyright © 2017 Elsevier Inc. All rights reserved.

CNS drug development in Europe--past progress and future challenges.

PubMed

Nutt, David J; Attridge, Jim

2014-01-01

Despite enormous progress in defining, diagnosing and treating mental disorders, EU health systems face a mounting challenge in responding to 'unmet need'. Mental illnesses produce a societal burden that exceeds that for either cancers or cardiovascular conditions. Leveraging advances in science and medicine to make available new innovative medicines is a key component in responding to this challenge. The dominant paradigm has been, is and will continue to be, one of incremental progress. Better medicines for depression, anxiety and psychoses in the working age population would add great value to patients and improve labour productivity. But psychotropic medicines face exceptional challenges in demonstrating their added value, due to uncertainty in patient diagnosis, selecting treatments and ensuring adherence. Also, there are major difficulties in estimating costs. Advances in understanding brain processes, identifying biomarkers and neuro-imaging techniques promise far more effective 'diagnostic-therapeutic' treatments and improved patient outcomes in the future. Currently there are valuable incremental innovations in late development, which may well fail to recover their R&D costs, because of very low reimbursed prices. This will send a signal to innovators not to persist with product development in this area. Recently several leading companies have withdrawn from R&D in these mental disorders. This is a worrying development since building the capabilities to succeed in any disease sector takes many years and, once dismantled, they cannot easily be re-established. Three policy interventions could improve innovation incentives: Further 'push' incentives under i) and streamlining under ii) alone will not reverse the decline in investment incentives. An EU consensus, based upon an innovation model which encompasses the Research, Development and Market phases as a single cyclical process, which addresses the weak 'market pull incentives' under iii) is needed. There is a very real risk that without such an integrated approach to policy reforms, innovation in psychotropic medicines will become a 'desert' in the same way that it did for antibiotics in the 1990's. Copyright © 2013 Elsevier Inc. All rights reserved.

An entrustable professional activity (EPA) for handoffs as a model for EPA assessment development.

PubMed

Aylward, Michael; Nixon, James; Gladding, Sophia

2014-10-01

Medical education is moving toward assessment of educational outcomes rather than educational processes. The American Board of Internal Medicine and American Board of Pediatrics milestones and the concept of entrustable professional activities (EPA)--skills essential to the practice of medicine that educators progressively entrust learners to perform--provide new approaches to assessing outcomes. Although some defined EPAs exist for internal medicine and pediatrics, the continued development and implementation of EPAs remains challenging. As residency programs are expected to begin reporting milestone-based performance, however, they will need examples of how to overcome these challenges. The authors describe a model for the development and implementation of an EPA using the resident handoff as an example. The model includes nine steps: selecting the EPA, determining where skills are practiced and assessed, addressing barriers to assessment, determining components of the EPA, determining needed assessment tools, developing new assessments if needed, determining criteria for advancement through entrustment levels, mapping milestones to the EPA, and faculty development. Following implementation, 78% of interns at the University of Minnesota Medical School were observed giving handoffs and provided feedback. The authors suggest that this model of EPA development--which includes engaging stakeholders, an iterative process to describing the behavioral characteristics of each domain at each level of entrustment, and the development of specific assessment tools that support both formative feedback and summative decisions about entrustment--can serve as a model for EPA development for other clinical skills and specialty areas.

Getting to the core of medicine: Developing undergraduate forensic medicine and pathology teaching.

PubMed

Jones, Richard Martin

2017-11-01

Teaching and learning of forensic medicine and pathology in the undergraduate medical curriculum has been in decline for decades in the UK, and yet graduates are expected to be able to recognise, and protect, those who are most vulnerable in society - i.e. at risk of abuse or neglect - a matter highly relevant to the role of the forensic medical practitioner. When Cardiff University School of Medicine created a new 'learner-centred' undergraduate curriculum, championing case-based discussion in small groups, and earlier clinical contact, residual teaching on 'the pathology of trauma' disappeared. An opportunity to create a new course for the year 3 core curriculum, however, led to re-emergence of forensic medicine and pathology, with a focus on identification, and protection, of the 'vulnerable patient'. This paper describes the development process of the first two iterations of that course, and the influence of 'listening to the student voice'. Forensic medicine and pathology remain relevant in undergraduate medical education; effective, and ethical, safeguarding of the vulnerable is an essential 'core' skill of the modern medical graduate, and forensic medical practitioners can play an integral role in the preparation of medical students for their future clinical practice. Copyright © 2017 Elsevier Ltd and Faculty of Forensic and Legal Medicine. All rights reserved.

Charting the Road to Competence: Developmental Milestones for Internal Medicine Residency Training

PubMed Central

Green, Michael L.; Aagaard, Eva M.; Caverzagie, Kelly J.; Chick, Davoren A.; Holmboe, Eric; Kane, Gregory; Smith, Cynthia D.; Iobst, William

2009-01-01

Background The Accreditation Council for Graduate Medical Education (ACGME) Outcome Project requires that residency program directors objectively document that their residents achieve competence in 6 general dimensions of practice. Intervention In November 2007, the American Board of Internal Medicine (ABIM) and the ACGME initiated the development of milestones for internal medicine residency training. ABIM and ACGME convened a 33-member milestones task force made up of program directors, experts in evaluation and quality, and representatives of internal medicine stakeholder organizations. This article reports on the development process and the resulting list of proposed milestones for each ACGME competency. Outcomes The task force adopted the Dreyfus model of skill acquisition as a framework the internal medicine milestones, and calibrated the milestones with the expectation that residents achieve, at a minimum, the “competency” level in the 5-step progression by the completion of residency. The task force also developed general recommendations for strategies to evaluate the milestones. Discussion The milestones resulting from this effort will promote competency-based resident education in internal medicine, and will allow program directors to track the progress of residents and inform decisions regarding promotion and readiness for independent practice. In addition, the milestones may guide curriculum development, suggest specific assessment strategies, provide benchmarks for resident self-directed assessment-seeking, and assist remediation by facilitating identification of specific deficits. Finally, by making explicit the profession's expectations for graduates and providing a degree of national standardization in evaluation, the milestones may improve public accountability for residency training. PMID:21975701

Behavioral medicine and prevention of non-communicable diseases in China: current challenges and future directions.

PubMed

Ding, Ding; Zhong, Xuefeng; Lau, Joseph Tak-Fai; Oldenburg, Brian

2014-08-01

We describe the emergence of recent public health challenges in China, particularly those regarding lifestyle-related non-communicable diseases (NCDs). We also summarize some recent examples of behavioral medicine research and practice in relation to the prevention and control of NCDs in China. Finally, we describe recent changes in the public health system in China and how behavioral medicine research and practice can be incorporated into this system to address these public health challenges. We considered research and policy literature from both China and Western countries in order to evaluate the relevance of the field of behavioral medicine for addressing the rising NCDs in China. Rapid economic development and related social and environmental changes have brought about increasing wealth and lifestyle changes in China, along with new public health challenges related to the prevention and control of NCDs. The field of behavioral medicine has much to offer China in addressing these public health challenges. Although behavioral medicine research and practice are still at an early stage in China, there are encouraging signs of its development, particularly resulting from international collaborations with researchers from Western countries. The next stage of this field's development in China will involve increased integration of behavioral medicine into public health education, training, and the health system. However, this process of integration will need to build on China's traditional approaches to public health training, research, and practice. Although the field of behavioral medicine in public health is still in its infancy in China, we argue that the practice and principles of behavioral medicine are important for successfully addressing the substantial burden of NCDs now and in the future.

Bridging the gap. The separate worlds of evidence-based medicine and patient-centered medicine.

PubMed

Bensing, J

2000-01-01

Modern medical care is influenced by two paradigms: 'evidence-based medicine' and 'patient-centered medicine'. In the last decade, both paradigms rapidly gained in popularity and are now both supposed to affect the process of clinical decision making during the daily practice of physicians. However, careful analysis shows that they focus on different aspects of medical care and have, in fact, little in common. Evidence-based medicine is a rather young concept that entered the scientific literature in the early 1990s. It has basically a positivistic, biomedical perspective. Its focus is on offering clinicians the best available evidence about the most adequate treatment for their patients, considering medicine merely as a cognitive-rational enterprise. In this approach the uniqueness of patients, their individual needs and preferences, and their emotional status are easily neglected as relevant factors in decision-making. Patient-centered medicine, although not a new phenomenon, has recently attracted renewed attention. It has basically a humanistic, biopsychosocial perspective, combining ethical values on 'the ideal physician', with psychotherapeutic theories on facilitating patients' disclosure of real worries, and negotiation theories on decision making. It puts a strong focus on patient participation in clinical decision making by taking into account the patients' perspective, and tuning medical care to the patients' needs and preferences. However, in this approach the ideological base is better developed than its evidence base. In modern medicine both paradigms are highly relevant, but yet seem to belong to different worlds. The challenge for the near future is to bring these separate worlds together. The aim of this paper is to give an impulse to this integration. Developments within both paradigms can benefit from interchanging ideas and principles from which eventually medical care will benefit. In this process a key role is foreseen for communication and communication research.

Development of an evidence-based review with recommendations using an online iterative process.

PubMed

Rudmik, Luke; Smith, Timothy L

2011-01-01

The practice of modern medicine is governed by evidence-based principles. Due to the plethora of medical literature, clinicians often rely on systematic reviews and clinical guidelines to summarize the evidence and provide best practices. Implementation of an evidence-based clinical approach can minimize variation in health care delivery and optimize the quality of patient care. This article reports a method for developing an "Evidence-based Review with Recommendations" using an online iterative process. The manuscript describes the following steps involved in this process: Clinical topic selection, Evidence-hased review assignment, Literature review and initial manuscript preparation, Iterative review process with author selection, and Manuscript finalization. The goal of this article is to improve efficiency and increase the production of evidence-based reviews while maintaining the high quality and transparency associated with the rigorous methodology utilized for clinical guideline development. With the rise of evidence-based medicine, most medical and surgical specialties have an abundance of clinical topics which would benefit from a formal evidence-based review. Although clinical guideline development is an important methodology, the associated challenges limit development to only the absolute highest priority clinical topics. As outlined in this article, the online iterative approach to the development of an Evidence-based Review with Recommendations may improve productivity without compromising the quality associated with formal guideline development methodology. Copyright © 2011 American Rhinologic Society-American Academy of Otolaryngic Allergy, LLC.

[Physiological effects of rare earth elements and their application in traditional Chinese medicine].

PubMed

Zhou, Jie; Guo, Lanping; Xiao, Wenjuan; Geng, Yanling; Wang, Xiao; Shi, Xin'gang; Dan, Staerk

2012-08-01

The process in the studies on physiological effects of rare earth elements in plants and their action mechanisms were summarized in the aspects of seed germination, photosynthesis, mineral metabolism and stress resistance. And the applications of rare earth elements in traditional Chinese medicine (TCM) in recent years were also overviewed, which will provide reference for further development and application of rare earth elements in TCM.

Current applications of molecular imaging and luminescence-based techniques in traditional Chinese medicine.

PubMed

Li, Jinhui; Wan, Haitong; Zhang, Hong; Tian, Mei

2011-09-01

Traditional Chinese medicine (TCM), which is fundamentally different from Western medicine, has been widely investigated using various approaches. Cellular- or molecular-based imaging has been used to investigate and illuminate the various challenges identified and progress made using therapeutic methods in TCM. Insight into the processes of TCM at the cellular and molecular changes and the ability to image these processes will enhance our understanding of various diseases of TCM and will provide new tools to diagnose and treat patients. Various TCM therapies including herbs and formulations, acupuncture and moxibustion, massage, Gua Sha, and diet therapy have been analyzed using positron emission tomography, single photon emission computed tomography, functional magnetic resonance imaging and ultrasound and optical imaging. These imaging tools have kept pace with developments in molecular biology, nuclear medicine, and computer technology. We provide an overview of recent developments in demystifying ancient knowledge - like the power of energy flow and blood flow meridians, and serial naturopathies - which are essential to visually and vividly recognize the body using modern technology. In TCM, treatment can be individualized in a holistic or systematic view that is consistent with molecular imaging technologies. Future studies might include using molecular imaging in conjunction with TCM to easily diagnose or monitor patients naturally and noninvasively. Copyright © 2011 Elsevier Ireland Ltd. All rights reserved.

Translating cell-based regenerative medicines from research to successful products: challenges and solutions.

PubMed

Bayon, Yves; Vertès, Alain A; Ronfard, Vincent; Egloff, Matthieu; Snykers, Sarah; Salinas, Gabriella Franco; Thomas, Robert; Girling, Alan; Lilford, Richard; Clermont, Gaelle; Kemp, Paul

2014-08-01

The Tissue Engineering & Regenerative Medicine International Society-Europe (TERMIS-EU) Industry Committee as well as its TERMIS-Americas (AM) counterpart intend to address the specific challenges and needs facing the industry in translating academic research into commercial products. Over the last 3 years, the TERMIS-EU Industry Committee has worked with commercial bodies to deliver programs that encourage academics to liaise with industry in proactive collaborations. The TERMIS-EU 2013 Industry Symposium aimed to build on this commercial agenda by focusing on two topics: Operations Management (How to move a process into the good manufacturing practice [GMP] environment) and Clinical Translation (Moving a GMP process into robust trials). These topics were introduced by providing the synergistic business perspective of partnering between the multiple regenerative medicine stakeholders, throughout the life cycle of product development. Seven industry leaders were invited to share their experience, expertise, and strategies. Due to the complex nature of regenerative medicine products, partnering for their successful commercial development seems inevitable to overcome all obstacles by sharing experiences and expertise of all stakeholders. When ideally implemented, the "innovation quotient" of a virtual team resulting from the combination of internal and external project teams can be maximized through maximizing the three main dimensions: core competences, technology portfolio, and alliance management.

The interweaving of pharmaceutical and medical expectations as dynamics of micro-pharmaceuticalisation: advanced-stage cancer patients' hope in medicines alongside trust in professionals.

PubMed

Brown, Patrick; de Graaf, Sabine; Hillen, Marij; Smets, Ellen; van Laarhoven, Hanneke

2015-04-01

Existing pharmaceuticalisation research denotes the salience of expectations in novel medicines and in the medical contexts through which these may be accessed. Specific processes of expectation such as hope and trust, alongside their shaping of patients' lifeworlds around pharmaceutical use, remain neglected however. Considering data from in-depth interviews and observations involving thirteen patients with advanced-stage cancer diagnoses who were or had recently been involved in clinical trials, we develop an interpretative phenomenological analysis of the influence of hope and trust upon the accessing of novel medicines through trials, illuminating the depth and texture of pharmaceuticalisation at the micro-level. Trust in clinicians and hope in trial medicines, for self and future patients, were important in the reconfiguring of patients' horizon of possibilities when accessing new medicines. Interwoven processes of trust and hope, embedded within heightened vulnerability, sustained the bracketing out of doubts regarding medicines, trials and professionals. The need to maintain hopes, and trusting relations with professionals who facilitated these hopes, generated meaning and momentum of medicines use which inhibited disengagement from trials. Findings indicate the taken-for-granted, as well as more reflexive, pursuit of solutions through medicines, which in this case-study enabled the generation of evidence through trial involvement. Analyses of micro-level dynamics within both downstream-consumption and upstream-substantiation of pharmaceutical solutions assist more nuanced accounts of interests, agency and expectations within pharmaceuticalisation. Copyright © 2014 Elsevier Ltd. All rights reserved.

An educational game for teaching clinical practice guidelines to Internal Medicine residents: development, feasibility and acceptability

PubMed Central

Akl, Elie A; Mustafa, Reem; Slomka, Thomas; Alawneh, Alia; Vedavalli, Abhishek; Schünemann, Holger J

2008-01-01

Background Adherence to Clinical Practice Guidelines (CPGs) remains suboptimal among internal medicine trainees. Educational games are of growing interest and have the potential to improve adherence to CPGs. The objectives of this study were to develop an educational game to teach CPGs in Internal Medicine residency programs and to evaluate its feasibility and acceptability. Methods We developed the Guide-O-Game© in the format of a TV game show with questions based on recommendations of CPGs. The development of the Guide-O-Game© consisted of the creation of a multimedia interactive tool, the development of recommendation-based questions, and the definition of the game's rules. We evaluated its feasibility through pilot testing and its acceptability through a qualitative process. Results The multimedia interactive tool uses a Macromedia Flash web application and consists of a manager interface and a user interface. The user interface allows the choice of two game styles. We created so far 16 sets of questions relating to 9 CPGs. The pilot testing proved that the game was feasible. The qualitative evaluation showed that residents considered the game to be acceptable. Conclusion We developed an educational game to teach CPGs to Internal Medicine residents that is both feasible and acceptable. Future work should evaluate its impact on educational outcomes. PMID:19017400

[Progress on studies of impact on CYP450 enzymes activity of traditional Chinese medicine by Cocktail probe substrates approach].

PubMed

Du, Xi; He, Xin; Huang, Yu-Hong; Li, Zi-Qiang

2016-12-01

Cocktail probe substrates approach is a fast, sensitive and high through put method to determine cytochrome P450 enzymes activity. It has been widely used to screen early drug development, analyze drug metabolism types and confirm the metabolism pathways, study drug-drug interactions, optimize clinical regimen, evaluate post marketing drugs and help liver/kidney pathological studies. This article reviewed characteristics of Cocktail probe substrates, focused on the application to traditional Chinese medicine to CYP450 system as follows: the metabolic pathway research of Chinese herb active ingredients; processing way and compatibility of medical herbs affect CYP450; find out the metabolic characteristic of Chinese patent medicine, study in pharmacy of national minority; do research in liver protective effect of traditional Chinese medicine and evaluate traditional Chinese medicine syndromes in animal models. This article make a summary of existing research results and also make a comparison of cocktail probe substrates approach application to western medicine and Chinese medicine. Copyright© by the Chinese Pharmaceutical Association.

[Process and key points of clinical literature evaluation of post-marketing traditional Chinese medicine].

PubMed

Liu, Huan; Xie, Yanming

2011-10-01

The clinical literature evaluation of the post-marketing traditional Chinese medicine is a comprehensive evaluation by the comprehensive gain, analysis of the drug, literature of drug efficacy, safety, economy, based on the literature evidence and is part of the evaluation of evidence-based medicine. The literature evaluation in the post-marketing Chinese medicine clinical evaluation is in the foundation and the key position. Through the literature evaluation, it can fully grasp the information, grasp listed drug variety of traditional Chinese medicines second development orientation, make clear further clinical indications, perfect the medicines, etc. This paper discusses the main steps and emphasis of the clinical literature evaluation. Emphasizing security literature evaluation should attach importance to the security of a comprehensive collection drug information. Safety assessment should notice traditional Chinese medicine validity evaluation in improving syndrome, improveing the living quality of patients with special advantage. The economics literature evaluation should pay attention to reliability, sensitivity and practicability of the conclusion.

WHO expert committee on specifications for pharmaceutical preparations.

PubMed

2013-01-01

The Expert Committee on Specifications for Pharmaceutical Preparations works towards clear, independent and practical standards and guidelines for the quality assurance of medicines. Standards are developed by the Committee through worldwide consultation and an international consensus-building process. The following new guidelines were adopted and recommended for use: Release procedure for International Chemical Reference Substances; WHO guidelines on quality risk management; WHO guidelines on variations to a prequalified product; and the Collaborative procedure between the World Health Organization Prequalification of Medicines Programme and national medicines regulatory authorities in the assessment and accelerated national registration of WHO-prequalified pharmaceutical products.

[Materials/Biomaterials in Clinical Practice - a Short Review and Current Trends].

PubMed

Bolle, T; Meyer, F; Walcher, F; Lohmann, C; Jockenhövel, S; Gries, T; Hoffmann, W

2017-04-01

Biomaterials play a major role in interventional medicine and surgery. However, the development of biomaterials is still in its early phases in spite of the huge progress made within the last decades. On the one hand, this is because our knowledge of the molecular and cellular processes associated with biomaterials is still increasing exponentially. On the other hand, a wide variety of advanced materials with highly interesting properties is being developed currently. This review provides a short introduction into the variety of materials in use as well as their application in interventional medicine and surgery. Also the importance of biomaterials for tissue engineering in the field of regenerative medicine and the functionalisation of biomaterials, including sterilisation methods are discussed. For the future, an even broader interdisciplinary scientific collaboration is necessary in order to develop novel biomaterials and facilitate their translation into clinical practice. Georg Thieme Verlag KG Stuttgart · New York.

[Advance in treatment of hyperuricemia by Chinese medicine based on uric acid transporterome].

PubMed

Zhou, Qi; Liu, Shu-min

2015-11-01

With the development of the quality of life, the morbidity of hyperuricemia is increasing year by year. At the same time, it appears that this disease attacks the young people currently. As the study of pathogenesis of hyperuricemia advanced, a series of uric acid transporters were found during this process. Meanwhile, the definition of transporterome was proposed. They were divided into three groups according to the functions: reabsorption proteins, excretion proteins and skeleton proteins. At moment, the drugs for hyperuricmia mainly include uric acid composition inhibitors and uric acid excretion promoters. Since the excretion of uric acid plays a leading role during the process of attack of hyperurecimia, it makes sense to explore Chinese medicines with clear mechanism targeting the transporterome. Therefore, this paper would focus on transporterome and summarize the mechanisms of Chinese medicines in treating hyperuricemia.

Innovative regenerative medicines in the EU: a better future in evidence?

PubMed

Corbett, Mark S; Webster, Andrew; Hawkins, Robert; Woolacott, Nerys

2017-03-08

Despite a steady stream of headlines suggesting they will transform the future of healthcare, high-tech regenerative medicines have, to date, been quite inaccessible to patients, with only eight having been granted an EU marketing licence in the last 7 years. Here, we outline some of the historical reasons for this paucity of licensed innovative regenerative medicines. We discuss the challenges to be overcome to expedite the development of this complex and rapidly changing area of medicine, together with possible reasons to be more optimistic for the future. Several factors have contributed to the scarcity of cutting-edge regenerative medicines in clinical practice. These include the great expense and difficulties involved in planning how individual therapies will be developed, manufactured to commercial levels and ultimately successfully delivered to patients. Specific challenges also exist when evaluating the safety, efficacy and cost-effectiveness of these therapies. Furthermore, many treatments are used without a licence from the European Medicines Agency, under "Hospital Exemption" from the EC legislation. For products which are licensed, alternative financing approaches by healthcare providers may be needed, since many therapies will have significant up-front costs but uncertain benefits and harms in the long-term. However, increasing political interest and more flexible mechanisms for licensing and financing of therapies are now evident; these could be key to the future growth and development of regenerative medicine in clinical practice. Recent developments in regulatory processes, coupled with increasing political interest, may offer some hope for improvements to the long and often difficult routes from laboratory to marketplace for leading-edge cell or tissue therapies. Collaboration between publicly-funded researchers and the pharmaceutical industry could be key to the future development of regenerative medicine in clinical practice; such collaborations might also offer a possible antidote to the innovation crisis in the pharmaceutical industry.

The Stability of Medicinal Plant microRNAs in the Herb Preparation Process.

PubMed

Xie, Wenyan; Melzig, Matthias F

2018-04-16

Herbal medicine is now globally accepted as a valid alternative system of pharmaceutical therapies. Various studies around the world have been initiated to develop scientific evidence-based herbal therapies. Recently, the therapeutic potential of medicinal plant derived miRNAs has attracted great attraction. MicroRNAs have been indicated as new bioactive ingredients in medicinal plants. However, the stability of miRNAs during the herbal preparation process and their bioavailability in humans remain unclear. Viscum album L. (European mistletoe) has been widely used in folk medicine for the treatment of cancer and cardiovascular diseases. Our previous study has indicated the therapeutic potential of mistletoe miRNAs by using bioinformatics tools. To evaluate the stability of these miRNAs, various mistletoe extracts that mimic the clinical medicinal use as well as traditional folk medicinal use were prepared. The mistletoe miRNAs including miR166a-3p, miR159a, miR831-5p, val-miR218 and val-miR11 were quantified by stem-loop qRT-PCR. As a result, miRNAs were detectable in the majority of the extracts, indicating that consumption of medicinal plant preparations might introduce miRNAs into mammals. The factors that might cause miRNA degradation include ultrasonic treatment, extreme heat, especially RNase treatment, while to be associated with plant molecules (e.g., proteins, exosomes) might be an efficient way to protect miRNAs against degradation. Our study confirmed the stability of plant derived miRNAs during herb preparations, suggesting the possibility of functionally intact medicinal plant miRNAs in mammals.

Audit of nuclear medicine scientific and technical standards.

PubMed

Jarritt, Peter H; Perkins, Alan C; Woods, Sandra D

2004-08-01

The British Nuclear Medicine Society has developed a process for the service-specific organizational audit of nuclear medicine departments. This process identified the need for a scheme suitable for the audit of the scientific and technical standards of a department providing such a service. This document has evolved following audit visits of a number of UK departments. It is intended to be used as a written document to facilitate the audit procedure and may be used for both external and self-audit purposes. Scientific and technical standards have been derived from a number of sources, including regulatory documents, notes for guidance and peer-reviewed publications. The audit scheme is presented as a series of questions with responses graded according to legal and safety obligations (A), good practice (B) and desirable aspects of service delivery (C). This document should be regarded as part of an audit framework and should be kept under review as the process evolves to meet the future demands of this high-technology-based clinical service.

[Strategy and collaboration between medicinal chemists and pharmaceutical scientists for drug delivery systems].

PubMed

Mano, Takashi

2013-01-01

In order to successfully apply drug delivery systems (DDS) to new chemical entities (NCEs), collaboration between medicinal chemists and formulation scientists is critical for efficient drug discovery. Formulation scientists have to use 'language' that medicinal chemists understand to help promote mutual understanding, and medicinal chemists and formulation scientists have to set up strategies to use suitable DDS technologies at the discovery phase of the programmes to ensure successful transfer into the development phase. In this review, strategies of solubilisation formulation for oral delivery, inhalation delivery, nasal delivery and bioconjugation are all discussed. For example, for oral drug delivery, multiple initiatives can be proposed to improve the process to select an optimal delivery option for an NCE. From a technical perspective, formulation scientists have to explain the scope and limitations of formulations as some DDS technologies might be applicable only to limited chemical spaces. Other limitations could be the administered dose and, cost, time and resources for formulation development and manufacturing. Since DDS selection is best placed as part of lead-optimisation, formulation scientists need to be involved in discovery projects at lead selection and optimisation stages. The key to success in their collaboration is to facilitate communication between these two areas of expertise at both a strategic and scientific level. Also, it would be beneficial for medicinal chemists and formulation scientists to set common goals to improve the process of collaboration and build long term partnerships to improve DDS.

International textbook of family medicine: the application of EURACT teaching agenda.

PubMed

Švab, Igor; Katić, Milica

2014-01-01

The paper describes experiences in the development of an international textbook of family medicine. The process of its development has started in Slovenia, where the Slovenian authors have written a textbook, adhering strictly to the European definition of family medicine and its core competencies. The format and the approach were also adopted by Croatian authors, who have used most of the material from the Slovenian book, but have modified some of the chapters according to the situation in the country and have added some of their own. This activity has created an opportunity for a truly international collaboration in the area of education of family medicine, with a creation of an international consortium, which would be responsible for the core content of the book and local adaptations of the book according to the specificities and needs of different countries. This innovative approach in the development of teaching material may be interesting for a variety of smaller countries in Europe and worldwide. Copyright © 2014 by Academy of Sciences and Arts of Bosnia and Herzegovina.

Training in interprofessional collaboration: pedagogic innovation in family medicine units.

PubMed

Paré, Line; Maziade, Jean; Pelletier, Francine; Houle, Nathalie; Iloko-Fundi, Maximilien

2012-04-01

A number of agencies that accredit university health sciences programs recently added standards for the acquisition of knowledge and skills with respect to interprofessional collaboration. Within primary care settings there are no practical training programs that allow students from different disciplines to develop competencies in this area. The training program was developed within family medicine units affiliated with Université Laval in Quebec for family medicine residents and trainees from various disciplines to develop competencies in patient-centred, interprofessional collaborative practice in primary care. Based on adult learning theories, the program was divided into 3 phases--preparing family medicine unit professionals, training preceptors, and training the residents and trainees. The program's pedagogic strategies allowed participants to learn with, from, and about one another while preparing them to engage in contemporary primary care practices. A combination of quantitative and qualitative methods was used to evaluate the implementation process and the immediate results of the training program. The training program had a positive effect on both the clinical settings and the students. Preparation of clinical settings is an important issue that must be considered when planning practical interprofessional training.

Effect of wine processing and acute blood stasis on the serum pharmacochemistry of rhubarb: a possible explanation for processing mechanism.

PubMed

Wang, Min; Fu, Jinfeng; Lv, Mengying; Tian, Yuan; Xu, Fengguo; Song, Rui; Zhang, Zunjian

2014-09-01

As a specific item mentioned in traditional Chinese medicine theory, processing can fulfill different requirements of therapies. Crude and wine-processed rhubarbs are used as drastic and mild laxatives, respectively. In this study, a practical method based on ultra-fast liquid chromatography coupled with diode-array detection and ion trap time-of-flight mass spectrometry was developed to screen and analyze multiple absorbed bioactive components and metabolites in the serum of both normal and acute blood stasis rats after oral administration of crude or wine-processed rhubarbs. A total of 16 compounds, mainly including phase II metabolites, were tentatively identified. Possible explanations for the processing-induced changes in pharmacological effects of traditional Chinese medicines were first explored at serum pharmacochemistry level. © 2014 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

Culture and Process Change as a Priority for Patient Engagement in Medicines Development

PubMed Central

Dewulf, Lode; Hoos, Anton; Geissler, Jan; Todaro, Veronica; Schneider, Roslyn F.; Garzya, Vincenzo; Garvey, Andrew; Robinson, Paul; Saffer, Tonya; Krug, Sarah; Sargeant, Ify

2016-01-01

Patient Focused Medicines Development (PFMD) is a not-for-profit independent multinational coalition of patients, patient stakeholders, and the pharmaceutical industry with interests across diverse disease areas and conditions. PFMD aims to facilitate an integrated approach to medicines development with all stakeholders involved early in the development process. A key strength of the coalition that differentiates it from other groups that involve patients or patient groups is that PFMD has patient organizations as founding members, ensuring that the patient perspective is the starting point when identifying priorities and developing solutions to meet patients’ needs. In addition, PFMD has from inception been formed as an equal collaboration among patient groups, patients, and pharmaceutical industry and has adopted a unique trans-Atlantic setup and scope that reflects its global intent. This parity extends to its governance model, which ensures at least equal or greater share of voice for patient group members. PFMD is actively inviting additional members and aims to expand the collaboration to include stakeholders from other sectors. The establishment of PFMD is particularly timely as patient engagement (PE) has become a priority for many health stakeholders and has led to a surge of mostly disconnected activities to deliver this. Given the current plethora of PE initiatives, an essential first step has been to determine, based on a comprehensive mapping, those strategic areas of most need requiring a focused initial effort from the perspective of all stakeholders. PFMD has identified four priority areas that will need to be addressed to facilitate implementation of PE. These are (1) culture and process change, (2) development of a global meta-framework for PE, (3) information exchange, and (4) training. This article discusses these priority themes and ongoing or planned PFMD activities within each. PMID:28232876

Culture and Process Change as a Priority for Patient Engagement in Medicines Development.

PubMed

Boutin, Marc; Dewulf, Lode; Hoos, Anton; Geissler, Jan; Todaro, Veronica; Schneider, Roslyn F; Garzya, Vincenzo; Garvey, Andrew; Robinson, Paul; Saffer, Tonya; Krug, Sarah; Sargeant, Ify

2017-01-01

Patient Focused Medicines Development (PFMD) is a not-for-profit independent multinational coalition of patients, patient stakeholders, and the pharmaceutical industry with interests across diverse disease areas and conditions. PFMD aims to facilitate an integrated approach to medicines development with all stakeholders involved early in the development process. A key strength of the coalition that differentiates it from other groups that involve patients or patient groups is that PFMD has patient organizations as founding members, ensuring that the patient perspective is the starting point when identifying priorities and developing solutions to meet patients' needs. In addition, PFMD has from inception been formed as an equal collaboration among patient groups, patients, and pharmaceutical industry and has adopted a unique trans-Atlantic setup and scope that reflects its global intent. This parity extends to its governance model, which ensures at least equal or greater share of voice for patient group members. PFMD is actively inviting additional members and aims to expand the collaboration to include stakeholders from other sectors. The establishment of PFMD is particularly timely as patient engagement (PE) has become a priority for many health stakeholders and has led to a surge of mostly disconnected activities to deliver this. Given the current plethora of PE initiatives, an essential first step has been to determine, based on a comprehensive mapping, those strategic areas of most need requiring a focused initial effort from the perspective of all stakeholders. PFMD has identified four priority areas that will need to be addressed to facilitate implementation of PE. These are (1) culture and process change, (2) development of a global meta-framework for PE, (3) information exchange, and (4) training. This article discusses these priority themes and ongoing or planned PFMD activities within each.

The development and evaluation of written medicines information for type 2 diabetes.

PubMed

Lee, D Y L; Armour, C; Krass, I

2007-12-01

Written Medicines Information (WMI) is regarded as a key component in diabetes consumer education. In Australia, there is a paucity of WMI that specifically tailors to the extensive array of medicines used for the lifelong management of Type 2 diabetes. This research project aimed to employ a novel framework, the 'Consumer Involvement Cycle', to investigate consumer perspectives and needs of medicines information for Type 2 diabetes and develop appropriate WMI for the Type 2 diabetes population. The Consumer Involvement Cycle involved people with Type 2 diabetes and health professionals (HPs) working in partnership to design a series of WMI, incorporating a range of consumer-conceived ideas and concepts with professional evaluation from an expert panel of reviewing HPs. A total of 12 leaflets were developed. The Flesch-Kincaid Grade Level Score for the leaflets was approximately 8.0, which is considered to be 'fairly easy', in other words easily understood by a large proportion of the general public. The Consumer Involvement Cycle was validated as a useful framework in developing and evaluating appropriate consumer information. Consumer perspectives should be sought and well incorporated throughout the process of designing and assessing educational materials intended for consumer use.

Quality Measures in Orthopaedic Sports Medicine: A Systematic Review.

PubMed

Abrams, Geoffrey D; Greenberg, Daniel R; Dragoo, Jason L; Safran, Marc R; Kamal, Robin N

2017-10-01

To report the current quality measures that are applicable to orthopaedic sports medicine physicians. Six databases were searched with a customized search term to identify quality measures relevant to orthopaedic sports medicine surgeons: MEDLINE/PubMed, EMBASE, the National Quality Forum (NQF) Quality Positioning System (QPS), the Agency for Healthcare Research and Quality (AHRQ) National Quality Measures Clearinghouse (NQMC), the Physician Quality Reporting System (PQRS) database, and the American Academy of Orthopaedic Surgeons (AAOS) website. Results were screened by 2 Board-certified orthopaedic surgeons with fellowship training in sports medicine and dichotomized based on sports medicine-specific or general orthopaedic (nonarthroplasty) categories. Hip and knee arthroplasty measures were excluded. Included quality measures were further categorized based on Donabedian's domains and the Center for Medicare and Medicaid (CMS) National Quality Strategy priorities. A total of 1,292 quality measures were screened and 66 unique quality measures were included. A total of 47 were sports medicine-specific and 19 related to the general practice of orthopaedics for a fellowship-trained sports medicine specialist. Nineteen (29%) quality measures were collected within PQRS, with 5 of them relating to sports medicine and 14 relating to general orthopaedics. AAOS Clinical Practice Guidelines (CPGs) comprised 40 (60%) of the included measures and were all within sports medicine. Five (8%) additional measures were collected within AHRQ and 2 (3%) within NQF. Most quality measures consist of process rather than outcome or structural measures. No measures addressing concussions were identified. There are many existing quality measures relating to the practice of orthopaedic sports medicine. Most quality measures are process measures described within PQRS or AAOS CPGs. Knowledge of quality measures are important as they may be used to improve care, are increasingly being used to determine physician reimbursement, and can inform future quality measure development efforts. Published by Elsevier Inc.

A CMMI-based approach for medical software project life cycle study.

PubMed

Chen, Jui-Jen; Su, Wu-Chen; Wang, Pei-Wen; Yen, Hung-Chi

2013-01-01

In terms of medical techniques, Taiwan has gained international recognition in recent years. However, the medical information system industry in Taiwan is still at a developing stage compared with the software industries in other nations. In addition, systematic development processes are indispensable elements of software development. They can help developers increase their productivity and efficiency and also avoid unnecessary risks arising during the development process. Thus, this paper presents an application of Light-Weight Capability Maturity Model Integration (LW-CMMI) to Chang Gung Medical Research Project (CMRP) in the Nuclear medicine field. This application was intended to integrate user requirements, system design and testing of software development processes into three layers (Domain, Concept and Instance) model. Then, expressing in structural System Modeling Language (SysML) diagrams and converts part of the manual effort necessary for project management maintenance into computational effort, for example: (semi-) automatic delivery of traceability management. In this application, it supports establishing artifacts of "requirement specification document", "project execution plan document", "system design document" and "system test document", and can deliver a prototype of lightweight project management tool on the Nuclear Medicine software project. The results of this application can be a reference for other medical institutions in developing medical information systems and support of project management to achieve the aim of patient safety.

Attention without intention: explicit processing and implicit goal-setting in family medicine residents' written reflections.

PubMed

Shaughnessy, Allen F; Allen, Lucas; Duggan, Ashley

2017-05-01

Reflection, a process of self-analysis to promote learning through better understanding of one's experiences, is often used to assess learners' metacognitive ability. However, writing reflective exercises, not submitted for assessment, may allow learners to explore their experiences and indicate learning and professional growth without explicitly connecting to intentional sense-making. To identify core components of learning about medicine or medical education from family medicine residents' written reflections. Family medicine residents' wrote reflections about their experiences throughout an academic year. Qualitative thematic analysis to identify core components in 767 reflections written by 33 residents. We identified four themes of learning: 'Elaborated reporting' and 'metacognitive monitoring' represent explicit, purposeful self-analysis that typically would be characterised as reflective learning about medicine. 'Simple reporting' and 'goal setting' signal an analysis of experience that indicates learning and professional growth but that is overlooked as a component of learning. Identified themes elucidate the explicit and implicit forms of written reflection as sense-making and learning. An expanded theoretical understanding of reflection as inclusive of conscious sense-making as well as implicit discovery better enables the art of physician self-development.

The position of the New York Academy of Medicine on physician-assisted suicide.

PubMed

Barondess, J A

1997-01-01

In January 1997, after a lengthy, careful, and difficult process, an ad hoc group, chaired by Dr. Alan R. Fleischman, a Senior Vice President of the New York Academy of Medicine (NYAM), with representation from clinical medicine, biomedical ethics, law, and the clergy, developed a position on the difficult and contentious issue of physician-assisted suicide. After substantial debate, the Board of Trustees of NYAM authorized a letter from the President of the Academy to the Justices of the United States Supreme Court and to the attorneys on both sides of the cases about to be argued before the Court. The text of that letter, which summarizes the views of the New York Academy of Medicine, is reproduced here.

Value added medicines: what value repurposed medicines might bring to society?

PubMed Central

Toumi, Mondher; Rémuzat, Cécile

2017-01-01

ABSTRACT Background & objectives: Despite the wide interest surrounding drug repurposing, no common terminology has been yet agreed for these products and their full potential value is not always recognised and rewarded, creating a disincentive for further development. The objectives of the present study were to assess from a wide perspective which value drug repurposing might bring to society, but also to identify key obstacles for adoption of these medicines and to discuss policy recommendations. Methods: A preliminary comprehensive search was conducted to assess how the concept of drug repurposing was described in the literature. Following completion of the literature review, a primary research was conducted to get perspective of various stakeholders across EU member states on drug repurposing (healthcare professionals, regulatory authorities and Health Technology Assessment (HTA) bodies/payers, patients, and representatives of the pharmaceutical industry developing medicines in this field). Ad hoc literature review was performed to illustrate, when appropriate, statements of the various stakeholders. Results: Various nomenclatures have been used to describe the concept of drug repurposing in the literature, with more or less broad definitions either based on outcomes, processes, or being a mix of both. In this context, Medicines for Europe (http://www.medicinesforeurope.com/value-added-medicines/) established one single terminology for these medicines, known as value added medicines, defined as ‘medicines based on known molecules that address healthcare needs and deliver relevant improvements for patients, healthcare professionals and/or payers’. Stakeholder interviews highlighted three main potential benefits for value added medicines: (1) to address a number of medicine-related healthcare inefficiencies related to irrational use of medicines, non-availability of appropriate treatment options, shortage of mature products, geographical inequity in medicine access; (2) to improve healthcare system efficiency; and (3) to contribute to sustainability of healthcare systems through economic advantages. Current HTA framework, generic stigma, and pricing rules, such as internal reference pricing or tendering processes in place in some countries, were reported as the current key hurdles preventing the full recognition of value added medicines’ benefits, discouraging manufacturers from bringing such products to the market. Discussion & conclusions: There is currently a gap between increasing regulatory authority interest in capturing value added medicines’ benefits and the resistance of HTA bodies/payers, who tend to ignore this important segment of the pharmaceutical field. This situation calls for policy changes to foster appropriate incentives to enhance value recognition of value added medicines and deliver the expected benefit to society. Policy changes from HTA perspective should include: absence of any legislative barriers preventing companies from pursuing HTA; HTA requirements proportionate to potential reward; HTA decision-making framework taking into account the specific characteristics of value added medicines; eligibility for early HTA dialogues; Policy changes from pricing perspective should encompass: tenders/procurement policies allowing differentiation from generic medicines; eligibility for early entry agreement; non-systematic implementation of external and internal reference pricing policies; recognition of indication-specific pricing. At the same time, the pharmaceutical industry should engage all the stakeholders (patients, healthcare providers, HTA bodies/payers) in early dialogues to identify their expectations and to ensure the developed value added medicines address their needs. PMID:28265347

Systematic review to support the development of nutrient reference intake values: challenges and solutions

USDA-ARS?s Scientific Manuscript database

Workshops sponsored by the Institute of Medicine (IOM) and the World Health Organization (WHO) suggested that incorporating systematic reviews into the process of updating nutrient reference values would enhance the transparency of the process. The IOM issues the Dietary Reference Intake values (DR...

Medical Simulations for Exploration Medicine

NASA Technical Reports Server (NTRS)

Reyes, David; Suresh, Rahul; Pavela, James; Urbina, Michelle; Mindock, Jennifer; Antonsen, Erik

2018-01-01

Medical simulation is a useful tool that can be used to train personnel, develop medical processes, and assist cross-disciplinary communication. Medical simulations have been used in the past at NASA for these purposes, however they are usually created ad hoc. A stepwise approach to scenario development has not previously been used. The NASA Exploration Medical Capability (ExMC) created a medical scenario development tool to test medical procedures, technologies, concepts of operation and for use in systems engineering (SE) processes.

Allocating limited resources in a time of fiscal constraints: a priority setting case study from Dalhousie University Faculty of Medicine.

PubMed

Mitton, Craig; Levy, Adrian; Gorsky, Diane; MacNeil, Christina; Dionne, Francois; Marrie, Tom

2013-07-01

Facing a projected $1.4M deficit on a $35M operating budget for fiscal year 2011/2012, members of the Dalhousie University Faculty of Medicine developed and implemented an explicit, transparent, criteria-based priority setting process for resource reallocation. A task group that included representatives from across the Faculty of Medicine used a program budgeting and marginal analysis (PBMA) framework, which provided an alternative to the typical public-sector approaches to addressing a budget deficit of across-the-board spending cuts and political negotiation. Key steps to the PBMA process included training staff members and department heads on priority setting and resource reallocation, establishing process guidelines to meet immediate and longer-term fiscal needs, developing a reporting structure and forming key working groups, creating assessment criteria to guide resource reallocation decisions, assessing disinvestment proposals from all departments, and providing proposal implementation recommendations to the dean. All departments were required to submit proposals for consideration. The task group approved 27 service reduction proposals and 28 efficiency gains proposals, totaling approximately $2.7M in savings across two years. During this process, the task group faced a number of challenges, including a tight timeline for development and implementation (January to April 2011), a culture that historically supported decentralized planning, at times competing interests (e.g., research versus teaching objectives), and reductions in overall health care and postsecondary education government funding. Overall, faculty and staff preferred the PBMA approach to previous practices. Other institutions should use this example to set priorities in times of fiscal constraints.

Assessing Integration of Clinical and Public Health Skills in Preventive Medicine Residencies: Using Competency Mapping

PubMed Central

Sarigiannis, Amy N.; Boulton, Matthew L.

2012-01-01

Objectives. We evaluated the utility of a competency mapping process for assessing the integration of clinical and public health skills in a newly developed Community Health Center (CHC) rotation at the University of Michigan School of Public Health Preventive Medicine residency. Methods. Learning objectives for the CHC rotation were derived from the Accreditation Council for Graduate Medical Education core clinical preventive medicine competencies. CHC learning objectives were mapped to clinical preventive medicine competencies specific to the specialty of public health and general preventive medicine. Objectives were also mapped to The Council on Linkages Between Academia and Public Health Practice’s tier 2 Core Competencies for Public Health Professionals. Results. CHC learning objectives mapped to all 4 (100%) of the public health and general preventive medicine clinical preventive medicine competencies. CHC population-level learning objectives mapped to 32 (94%) of 34 competencies for public health professionals. Conclusions. Utilizing competency mapping to assess clinical–public health integration in a new CHC rotation proved to be feasible and useful. Clinical preventive medicine learning objectives for a CHC rotation can also address public health competencies. PMID:22690972

Principles to Consider in Defining New Directions in Internal Medicine Training and Certification

PubMed Central

Turner, Barbara J; Centor, Robert M; Rosenthal, Gary E

2006-01-01

SGIM endoreses seven principles related to current thinking about internal medicine training: 1) internal medicine requires a full three years of residency training before subspecialization; 2) internal medicine residency programs must dramatically increase support for training in the ambulatory setting and offer equivalent opportunities for training in both inpatient and outpatient medicine; 3) in settings where adequate support and time are devoted to ambulatory training, the third year of residency could offer an opportunity to develop further expertise or mastery in a specific type or setting of care; 4) further certification in specific specialties within internal medicine requires the completion of an approved fellowship program; 5) areas of mastery in internal medicine can be demonstrated through modified board certification and recertification examinations; 6) certification processes throughout internal medicine should focus increasingly on demonstration of clinical competence through adherence to validated standards of care within and across practice settings; and 7) regardless of the setting in which General Internists practice, we should unite to promote the critical role that this specialty serves in patient care. PMID:16637826

Defining the Field of Behavioral Medicine: A Collaborative Endeavor.

PubMed

Dekker, Joost; Stauder, Adrienne; Penedo, Frank J

2017-02-01

To respond to comments on our proposal for an update of the definition and scope of behavioral medicine. We identify common themes in the comments and provide a response. We discuss the relationship of behavioral medicine to other disciplines and fields, the scope of behavioral medicine, and issues related to the application of behavioral medicine. Based on the comments of our esteemed colleagues and our reflection on those comments, we now offer the following refined definition and scope of behavioral medicine. 'Behavioral medicine can be defined as the field characterized by the collaboration among multiple disciplines concerned with the development and integration of biomedical and behavioral knowledge relevant to health and disease, and the application of this knowledge to prevention, health promotion, diagnosis, treatment, rehabilitation, and care. The scope of behavioral medicine extends from bio-behavioral mechanisms (i.e. the interaction among biomedical, psychological, social, societal, cultural and environmental processes related to health and disease), to clinical diagnosis and intervention, and to public health'. We propose to use this refined definition and scope as the starting point for seeking further input from the ISBM member societies.

Defining the Path Forward: Guidance for Laboratory Medicine Guidelines

PubMed Central

Jones, Patricia M.; Chin, Alex C.; Christenson, Robert H.

2015-01-01

The National Academy of Clinical Biochemistry (NACB) has developed consensus-based guidelines for the laboratory evaluation and monitoring of patients with specified disorders for two decades. In 1997, the NACB recognized the need to standardize the process of guideline development and promulgated its first Standard Operating Procedure (SOP) for this purpose. In 2010, the American Association of Clinical Chemistry (AACC) and NACB created the Evidence-Based Laboratory Medicine Committee (EBLMC). Among other roles, this group was given responsibility to provide oversight of clinical practice guideline development in accordance with SOP guidance and using currently accepted good practices. In 2011, the U.S. Institute of Medicine (IOM) published two reports of relevance: ‘Clinical Practice Guidelines We Can Trust’ and ‘Finding What Works in Health Care – Standards for Systematic Reviews.’ These reports were created as part of a response to a legislative mandate from the U.S. Congress requesting that steps be taken to implement recommendations from lOM’s report on ‘Knowing What Works in Health Care’ (2008). The latest revision of the laboratory medicine practice guidelines (LMPG) SOP was in part driven by these reports. NACB continues to develop LMPGs at a rate of roughly one per year through standard processes detailed in its 2014 revision of the SOP. This article describes the NACB and EBLMC experience in developing LMPGs with a focus on the evolution and use of the latest SOP. AACC and NACB have established a solid track record in collaboratively working with many clinical societies and professional organizations on clinical practice guideline development. Presently, three LMPG’s are in various stages of development and all with the collaboration of other clinical/professional groups. The practices and tools being used for current LMPGs in progress are also highlighted in the context of the challenges that presently exist for effective clinical practice guideline development in the U.S. PMID:27683491

Application of process mapping to understand integration of high risk medicine care bundles within community pharmacy practice.

PubMed

Weir, Natalie M; Newham, Rosemary; Corcoran, Emma D; Ali Atallah Al-Gethami, Ashwag; Mohammed Abd Alridha, Ali; Bowie, Paul; Watson, Anne; Bennie, Marion

2017-11-21

The Scottish Patient Safety Programme - Pharmacy in Primary Care collaborative is a quality improvement initiative adopting the Institute of Healthcare Improvement Breakthrough Series collaborative approach. The programme developed and piloted High Risk Medicine (HRM) Care Bundles (CB), focused on warfarin and non-steroidal anti-inflammatories (NSAIDs), within 27 community pharmacies over 4 NHS Regions. Each CB involves clinical assessment and patient education, although the CB content varies between regions. To support national implementation, this study aims to understand how the pilot pharmacies integrated the HRM CBs into routine practice to inform the development of a generic HRM CB process map. Regional process maps were developed in 4 pharmacies through simulation of the CB process, staff interviews and documentation of resources. Commonalities were collated to develop a process map for each HRM, which were used to explore variation at a national event. A single, generic process map was developed which underwent validation by case study testing. The findings allowed development of a generic process map applicable to warfarin and NSAID CB implementation. Five steps were identified as required for successful CB delivery: patient identification; clinical assessment; pharmacy CB prompt; CB delivery; and documentation. The generic HRM CB process map encompasses the staff and patients' journey and the CB's integration into routine community pharmacy practice. Pharmacist involvement was required only for clinical assessment, indicating suitability for whole-team involvement. Understanding CB integration into routine practice has positive implications for successful implementation. The generic process map can be used to develop targeted resources, and/or be disseminated to facilitate CB delivery and foster whole team involvement. Similar methods could be utilised within other settings, to allow those developing novel services to distil the key processes and consider their integration within routine workflows to effect maximal, efficient implementation and benefit to patient care. Copyright © 2017 Elsevier Inc. All rights reserved.

The European Medicines Agency experience with biomarker qualification.

PubMed

Manolis, Efthymios; Koch, Armin; Deforce, Dieter; Vamvakas, Spiros

2015-01-01

Since the launch of the qualification process in 2009, the CHMP reviewed/is reviewing 48 requests for qualification advice or opinion (as of Sept 2013) related to biomarkers (BM) or other novel drug development tools (e.g. patient reported outcome measures, modeling, and statistical methods). The qualification opinions are available on the EMA website (Qualification of novel methodologies for medicine development, http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/document_listing/document_listing_000319.jsp&mid=WC0b01ac0580022bb0#section2 , 2013). Also there is a trend of increasing numbers of qualification requests to CHMP, indicative of the pace that targeted drug development and personalized medicine is gaining and the need to bring the new tools from research to drug development and clinical use. This chapter will focus on the regulatory experience gained so far from the CHMP qualification procedure. Basic qualification principles will be presented. Through qualification examples, we will elaborate on common grounds and divergences between the different stakeholders.

Guiding principles of safety as a basis for developing a pharmaceutical safety culture.

PubMed

Edwards, Brian; Olsen, Axel K; Whalen, Matthew D; Gold, Marla J

2007-05-01

Despite the best efforts of industry and regulatory authorities, the trust of society in the process of medicine development and communication of pharmaceutical risk has ebbed away. In response the US government has called for a culture of compliance while the EU regulators talk of a 'culture of scientific excellence'. However, one of the fundamental problems hindering progress to rebuilding trust based on a pharmaceutical safety culture is the lack of agreement and transparency between all stakeholders as to what is meant by a 'Safety of Medicines'. For that reason, we propose 'Guiding Principles of Safety for Pharmaceuticals' are developed analogous to the way that Chemical Safety has been tackled. A logical starting point would be to examine the Principles outlined by the US Institute of Medicine although we acknowledge that these Principles require further extensive debate and definition. Nevertheless, the Principles should take centre stage in the reform of pharmaceutical development required to restore society's trust.

Pediatric Medicine Development: An Overview and Comparison of Regulatory Processes in the European Union and United States

PubMed Central

Penkov, Dobromir; Tomasi, Paolo; Eichler, Irmgard; Murphy, Dianne; Yao, Lynne P.; Temeck, Jean

2017-01-01

Pediatric legislation in the US and the EU is driving pediatric product development on an international scale. To facilitate harmonization and global development of pediatric medicines, it is important to understand the legislative requirements that must be met along with incentives that exist in the US and the EU to include pediatric patients in therapeutic clinical trials. Although there are many similarities, differences exist. This review is an effort to enhance understanding of the pediatric legislation in both regions. It is intended as an overview to supplement the region-specific legislation and guidance documents that are available on the websites of the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA). Despite differences, the goal of the legislation in both the EU and the US is to incentivize and require timely, ethical, and sound scientific development of pharmaceutical products for the pediatric population and to provide information for their safe and effective use. PMID:28674673

Space Medicine in the Human System Integration Process

NASA Technical Reports Server (NTRS)

Scheuring, Richard A.

2010-01-01

This slide presentation reviews the importance of integration of space medicine in the human system of lunar exploration. There is a review of historical precedence in reference to lunar surface operations. The integration process is reviewed in a chart which shows the steps from research to requirements development, requirements integration, design, verification, operations and using the lessons learned, giving more information and items for research. These steps are reviewed in view of specific space medical issues. Some of the testing of the operations are undertaken in an environment that is an analog to the exploration environment. Some of these analog environments are reviewed, and there is some discussion of the benefits of use of an analog environment in testing the processes that are derived.

Advances in medical image computing.

PubMed

Tolxdorff, T; Deserno, T M; Handels, H; Meinzer, H-P

2009-01-01

Medical image computing has become a key technology in high-tech applications in medicine and an ubiquitous part of modern imaging systems and the related processes of clinical diagnosis and intervention. Over the past years significant progress has been made in the field, both on methodological and on application level. Despite this progress there are still big challenges to meet in order to establish image processing routinely in health care. In this issue, selected contributions of the German Conference on Medical Image Processing (BVM) are assembled to present latest advances in the field of medical image computing. The winners of scientific awards of the German Conference on Medical Image Processing (BVM) 2008 were invited to submit a manuscript on their latest developments and results for possible publication in Methods of Information in Medicine. Finally, seven excellent papers were selected to describe important aspects of recent advances in the field of medical image processing. The selected papers give an impression of the breadth and heterogeneity of new developments. New methods for improved image segmentation, non-linear image registration and modeling of organs are presented together with applications of image analysis methods in different medical disciplines. Furthermore, state-of-the-art tools and techniques to support the development and evaluation of medical image processing systems in practice are described. The selected articles describe different aspects of the intense development in medical image computing. The image processing methods presented enable new insights into the patient's image data and have the future potential to improve medical diagnostics and patient treatment.

Evaluating Quality of Decision-Making Processes in Medicines' Development, Regulatory Review, and Health Technology Assessment: A Systematic Review of the Literature.

PubMed

Bujar, Magdalena; McAuslane, Neil; Walker, Stuart R; Salek, Sam

2017-01-01

Introduction: Although pharmaceutical companies, regulatory authorities, and health technology assessment (HTA) agencies have been increasingly using decision-making frameworks, it is not certain whether these enable better quality decision making. This could be addressed by formally evaluating the quality of decision-making process within those organizations. The aim of this literature review was to identify current techniques (tools, questionnaires, surveys, and studies) for measuring the quality of the decision-making process across the three stakeholders. Methods: Using MEDLINE, Web of Knowledge, and other Internet-based search engines, a literature review was performed to systematically identify techniques for assessing quality of decision making in medicines development, regulatory review, and HTA. A structured search was applied using key words and a secondary review was carried out. In addition, the measurement properties of each technique were assessed and compared. Ten Quality Decision-Making Practices (QDMPs) developed previously were then used as a framework for the evaluation of techniques identified in the review. Due to the variation in studies identified, meta-analysis was inappropriate. Results: This review identified 13 techniques, where 7 were developed specifically to assess decision making in medicines' development, regulatory review, or HTA; 2 examined corporate decision making, and 4 general decision making. Regarding how closely each technique conformed to the 10 QDMPs, the 13 techniques assessed a median of 6 QDMPs, with a mode of 3 QDMPs. Only 2 techniques evaluated all 10 QDMPs, namely the Organizational IQ and the Quality of Decision Making Orientation Scheme (QoDoS), of which only one technique, QoDoS could be applied to assess decision making of both individuals and organizations, and it possessed generalizability to capture issues relevant to companies as well as regulatory authorities. Conclusion: This review confirmed a general paucity of research in this area, particularly regarding the development and systematic application of techniques for evaluating quality decision making, with no consensus around a gold standard. This review has identified QoDoS as the most promising available technique for assessing decision making in the lifecycle of medicines and the next steps would be to further test its validity, sensitivity, and reliability.

A Successful Strategy to Integrate Sex and Gender Medicine into a Newly Developed Medical Curriculum.

PubMed

Ludwig, Sabine; Oertelt-Prigione, Sabine; Kurmeyer, Christine; Gross, Manfred; Grüters-Kieslich, Annette; Regitz-Zagrosek, Vera; Peters, Harm

2015-12-01

A new modular, outcome-based, interdisciplinary curriculum was introduced for undergraduate medical education at one of the largest European medical faculties. A key stated institutional goal was to systematically integrate sex and gender medicine and gender perspectives into the curriculum in order to foster adequate gender-related knowledge and skills for future doctors concerning the etiology, pathogenesis, clinical presentation, diagnosis, treatment, and research of diseases. A change agent was integrated directly into the curriculum development team to facilitate interactions with all key players of the curricular development process. The gender change agent established a supporting organizational framework of all stakeholders, and developed a 10-step approach including identification, selection, placing relevant sex and gender medicine-related issues in the curricular planning sessions, counseling of faculty members, and monitoring of the integration achieved. With this approach, quantitatively sex and gender medicine-related content was widely integrated throughout all teaching and learning formats and from early basic science to later clinical modules (94 lectures, 33 seminars, and 16 practical courses). Gender perspectives involve 5% of the learning objectives and represent an integral part of the assessment program. Qualitatively, the relevance of gender (sociocultural) differences was combined with sex (biological) differences in disease manifestation throughout the curriculum. The appointment of a change agent facilitates the development of systematic approaches that can be a key and serve as practice models to successfully integrate new overarching curricular perspectives and dimensions--in this case sex and gender medicine--into a new medical curriculum.

AAVP Recommendations for Core Competency Standards Relating to Parasitological Knowledge and Skills.

PubMed

Snowden, Karen F; Krecek, Rosina C; Bowman, Dwight D

As part of the accreditation process, the American Veterinary Medical Association Council on Education has defined nine broad areas of core competencies that must be met by graduating students earning a Doctor of Veterinary Medicine degree. To define competencies in veterinary parasitology, the American Association of Veterinary Parasitologists (AAVP) has developed a detailed list of knowledge and skills that are recommended for inclusion in professional curricula. These recommendations were developed by instructors from colleges/schools of veterinary medicine in the US, Canada, and the Caribbean, and were reviewed and endorsed following AAVP guidelines.

Carers' experiences of home enteral feeding: A survey exploring medicines administration challenges and strategies.

PubMed

Alsaeed, D; Furniss, D; Blandford, A; Smith, F; Orlu, M

2018-06-01

The use of enteral tube feeding at home is becoming more widespread, with patients ranging in age and diseases. Dysphagia and swallowing difficulties can compromise nutritional intake and the administration of oral medications, affecting therapeutic outcomes negatively. Carers' experiences of medicines administration and medicines optimization have not been explored fully. The objectives of this study were to identify issues carers experience in medicines administration; the strategies they have developed to cope; and suggestions to improve the medicines administration process. An online survey was promoted nationally; 42 carers completed it. Descriptive statistical analysis was applied, as well as thematic analysis of open-ended responses. Results were compared against the 4 principles of medicines optimization. 93% of respondents administered medications with enteral feeding tubes, but only 62% had received advice from healthcare professionals and only 8% had received written information on how to do so. Responses identified 5 medicines administration issues experienced by carers; 4 strategies they developed to cope; and 3 main areas of suggestions to improve medicines administration via enteral feeding at home. The 4 principles of medicines optimization have not previously been applied to enteral feeding. We present a novel account of carers' experiences, for example coping with ill-suited formulations and a lack of training and support, which should inform better practice (Principle 1). Carers sometimes experience suboptimal choice of medicines (Principle 2). Carers' practices are not always well-informed and may affect therapeutic outcomes and safety (Principle 3). There is scope for improvement in carer training, education and support to better support medicines optimization (Principle 4). © 2018 The Authors. Journal of Clinical Pharmacy and Therapeutics Published by John Wiley & Sons Ltd.

Utilizing a Trauma Systems Approach to Benchmark and Improve Combat Casualty Care

DTIC Science & Technology

2010-07-01

modern battlefield utilizing evidence - based medicine . The development of injury care benchmarks enhanced the evolution of the combat casualty care performance improvement process within the trauma system.

Development of ethical rules for boundaries of touch in complementary medicine--outcomes of a Delphi process.

PubMed

Schiff, Elad; Ben-Arye, Eran; Shilo, Margalit; Levy, Moti; Schachter, Leora; Weitchner, Na'ama; Golan, Ofra; Stone, Julie

2010-11-01

The practice of complementary medicine (CAM) often involves touch. The unique philosophy of many CAM therapies, and the setting in which treatments are provided create a therapeutic space which may be less clearly defined than in conventional settings - a space in which the boundaries between professional touch and personal/intimate touch may become easily obscured. Thus, complementary therapists need clear definitions and firm boundaries in order to maintain therapeutic efficacy and commitment. The aim of the process described in this article, was to develop ethical guidelines for boundaries of touch that will promote the safety and protection of the public which use CAM. Through a modified Delphi process, a diverse group of CAM practitioners, physicians, ethicists, legal consultants, health policy specialists, and representatives from the public, developed Ethical Rules for Boundaries of Touch in CAM. These guidelines may be implemented in ethical codes of professional CAM organizations, and also serve as a foundation for curriculums in ethics in CAM schools. Copyright © 2010 Elsevier Ltd. All rights reserved.

Medical student disaster medicine education: the development of an educational resource

PubMed Central

Domres, Bernd D.; Stahl, Wolfgang; Bauer, Andreas; Houser, Christine M.; Himmelseher, Sabine

2010-01-01

Background Disaster medicine education is an enormous challenge, but indispensable for disaster preparedness. Aims We aimed to develop and implement a disaster medicine curriculum for medical student education that can serve as a peer-reviewed, structured educational guide and resource. Additionally, the process of designing, approving and implementing such a curriculum is presented. Methods The six-step approach to curriculum development for medical education was used as a formal process instrument. Recognized experts from professional and governmental bodies involved in disaster health care provided input using disaster-related physician training programs, scientific evidence if available, proposals for education by international disaster medicine organizations and their expertise as the basis for content development. Results The final course consisted of 14 modules composed of 2-h units. The concepts of disaster medicine, including response, medical assistance, law, command, coordination, communication, and mass casualty management, are introduced. Hospital preparedness plans and experiences from worldwide disaster assistance are reviewed. Life-saving emergency and limited individual treatment under disaster conditions are discussed. Specifics of initial management of explosive, war-related, radiological/nuclear, chemical, and biological incidents emphasizing infectious diseases and terrorist attacks are presented. An evacuation exercise is completed, and a mass casualty triage is simulated in collaboration with local disaster response agencies. Decontamination procedures are demonstrated at a nuclear power plant or the local fire department, and personal decontamination practices are exercised. Mannequin resuscitation is practiced while personal protective equipment is utilized. An interactive review of professional ethics, stress disorders, psychosocial interventions, and quality improvement efforts complete the training. Conclusions The curriculum offers medical disaster education in a reasonable time frame, interdisciplinary format, and multi-experiential course. It can serve as a template for basic medical student disaster education. Because of its comprehensive but flexible structure, it should also be helpful for other health-care professional student disaster education programs. PMID:20414376

Identifying public health competencies relevant to family medicine.

PubMed

Harvey, Bart J; Moloughney, Brent W; Iglar, Karl T

2011-10-01

Public health situations faced by family physicians and other primary care practitioners, such as severe acute respiratory syndrome (SARS) and more recently H1N1, have resulted in an increased interest to identify the public health competencies relevant to family medicine. At present there is no agreed-on set of public health competencies delineating the knowledge and skills that family physicians should possess to effectively face diverse public health challenges. Using a multi-staged, iterative process that included a detailed literature review, the authors developed a set of public health competencies relevant to primary care, identifying competencies relevant across four levels, from "post-MD" to "enhanced." Feedback from family medicine and public health educator-practitioners regarding the set of proposed "essential" competencies indicated the need for a more limited, feasible set of "priority" areas to be highlighted during residency training. This focused set of public health competencies has begun to guide relevant components of the University of Toronto's Family Medicine Residency Program curriculum, including academic half-days; clinical experiences, especially identifying "teachable moments" during patient encounters; resident academic projects; and elective public health agency placements. These competencies will also be used to guide the development of a family medicine-public health primer and faculty development sessions to support family medicine faculty facilitating residents to achieve these competencies. Once more fully implemented, an evaluation will be initiated to determine the degree to which these public health competencies are being achieved by family medicine graduates, especially whether they attained the knowledge, skills, and confidence necessary to effectively face diverse public health situations-from common to emergent. Copyright © 2011 American Journal of Preventive Medicine. Published by Elsevier Inc. All rights reserved.

Quality assessment of clinical practice guidelines for integrative medicine in China: A systematic review.

PubMed

Yao, Sha; Wei, Dang; Chen, Yao-Long; Wang, Qi; Wang, Xiao-Qin; Zeng, Zhao; Li, Hui

2017-05-01

To assess the quality of integrative medicine clinical practice guidelines (CPGs) published before 2014. A systematic search of the scientific literature published before 2014 was conducted to select integrative medicine CPGs. Four major Chinese integrated databases and one guideline database were searched: the Chinese Biomedical Literature Database (CBM), the China National Knowledge Infrastructure (CNKI), China Science and Technology Journal Database (VIP), Wanfang Data, and the China Guideline Clearinghouse (CGC). Four reviewers independently assessed the quality of the included guidelines using the Appraisal of Guidelines for Research and Evaluation (AGREE) II Instrument. Overall consensus among the reviewers was assessed using the intra-class correlation coefficient (ICC). A total of 41 guidelines published from 2003 to 2014 were included. The overall consensus among the reviewers was good [ICC: 0.928; 95% confifi dence interval (CI): 0.920 to 0.935]. The scores on the 6 AGREE domains were: 17% for scope and purpose (range: 6% to 32%), 11% for stakeholder involvement (range: 0 to 24%), 10% for rigor of development (range: 3% to 22%), 39% for clarity and presentation (range: 25% to 64%), 11% for applicability (range: 4% to 24%), and 1% for editorial independence (range: 0 to 15%). The quality of integrative medicine CPGs was low, the development of integrative medicine CPGs should be guided by systematic methodology. More emphasis should be placed on multi-disciplinary guideline development groups, quality of evidence, management of funding and conflfl icts of interest, and guideline updates in the process of developing integrative medicine CPGs in China.

The National Clinical Assessment Tool for Medical Students in the Emergency Department (NCAT-EM)

PubMed Central

Jung, Julianna; Franzen, Douglas; Lawson, Luan; Manthey, David; Tews, Matthew; Dubosh, Nicole; Fisher, Jonathan; Haughey, Marianne; House, Joseph B.; Trainor, Arleigh; Wald, David A.; Hiller, Katherine

2018-01-01

Introduction Clinical assessment of medical students in emergency medicine (EM) clerkships is a highly variable process that presents unique challenges and opportunities. Currently, clerkship directors use institution-specific tools with unproven validity and reliability that may or may not address competencies valued most highly in the EM setting. Standardization of assessment practices and development of a common, valid, specialty-specific tool would benefit EM educators and students. Methods A two-day national consensus conference was held in March 2016 in the Clerkship Directors in Emergency Medicine (CDEM) track at the Council of Residency Directors in Emergency Medicine (CORD) Academic Assembly in Nashville, TN. The goal of this conference was to standardize assessment practices and to create a national clinical assessment tool for use in EM clerkships across the country. Conference leaders synthesized the literature, articulated major themes and questions pertinent to clinical assessment of students in EM, clarified the issues, and outlined the consensus-building process prior to consensus-building activities. Results The first day of the conference was dedicated to developing consensus on these key themes in clinical assessment. The second day of the conference was dedicated to discussing and voting on proposed domains to be included in the national clinical assessment tool. A modified Delphi process was initiated after the conference to reconcile questions and items that did not reach an a priori level of consensus. Conclusion The final tool, the National Clinical Assessment Tool for Medical Students in Emergency Medicine (NCAT-EM) is presented here. PMID:29383058

Cell/tissue processing information system for regenerative medicine.

PubMed

Iwayama, Daisuke; Yamato, Masayuki; Tsubokura, Tetsuya; Takahashi, Minoru; Okano, Teruo

2016-11-01

When conducting clinical studies of regenerative medicine, compliance to good manufacturing practice (GMP) is mandatory, and thus much time is needed for manufacturing and quality management. It is therefore desired to introduce the manufacturing execution system (MES), which is being adopted by factories manufacturing pharmaceutical products. Meanwhile, in manufacturing human cell/tissue processing autologous products, it is necessary to protect patients' personal information, prevent patients from being identified and obtain information for cell/tissue identification. We therefore considered it difficult to adopt conventional MES to regenerative medicine-related clinical trials, and so developed novel software for production/quality management to be used in cell-processing centres (CPCs), conforming to GMP. Since this system satisfies the requirements of regulations in Japan and the USA for electronic records and electronic signatures (ER/ES), the use of ER/ES has been allowed, and the risk of contamination resulting from the use of recording paper has been eliminated, thanks to paperless operations within the CPC. Moreover, to reduce the risk of mix-up and cross-contamination due to contact during production, we developed a touchless input device with built-in radio frequency identification (RFID) reader-writer devices and optical sensors. The use of this system reduced the time to prepare and issue manufacturing instructions by 50% or more, compared to the conventional handwritten system. The system contributes to producing more large-scale production and to reducing production costs for cell and tissue products in regenerative medicine. Copyright © 2014 John Wiley & Sons, Ltd. Copyright © 2014 John Wiley & Sons, Ltd.

How Entrustment Is Informed by Holistic Judgments Across Time in a Family Medicine Residency Program: An Ethnographic Nonparticipant Observational Study.

PubMed

Sagasser, Margaretha H; Fluit, Cornelia R M G; van Weel, Chris; van der Vleuten, Cees P M; Kramer, Anneke W M

2017-06-01

Entrustment has mainly been conceptualized as delegating discrete professional tasks. Because residents provide most of their patient care independently, not all resident performance is visible to supervisors; the entrustment process involves more than granting discrete tasks. This study explored how supervisors made entrustment decisions based on residents' performance in a long-term family medicine training program. A qualitative nonparticipant observational study was conducted in 2014-2015 at competency-based family medicine residency programs in the Netherlands. Seven supervisor-resident pairs participated. During two days, one researcher observed first-year residents' patient encounters, debriefing sessions, and supervisor-resident educational meetings and interviewed them separately afterwards. Data were collected and analyzed using iterative, phenomenological inductive research methodology. The entrustment process developed over three phases. Supervisors based their initial entrustment on prior knowledge about the resident. In the ensuing two weeks, entrustment decisions regarding independent patient care were derived from residents' observed general competencies necessary for a range of health problems (clinical reasoning, decision making, relating to patients); medical knowledge and skills; and supervisors' intuition. Supervisors provided supervision during and after encounters. Once residents performed independently, supervisors kept reevaluating their decisions, informed by residents' overall growth in competencies rather than by adhering to a predefined set of tasks. Supervisors in family medicine residency training took a holistic approach to trust, based on general competencies, knowledge, skills, and intuition. Entrustment started before training and developed over time. Building trust is a mutual process between supervisor and resident, requiring a good working relationship.

Emil Godlewski, Jr. (1875-1944) pioneer of embryology at the Jagiellonian University of Krakow (Poland).

PubMed

Sliwa, Leopold

2008-01-01

Emil Godlewski, Jr. (1875-1944) lived and worked in Krakow. He graduated from the Faculty of Medicine of the Jagiellonian University with the title of Doctor of Medical Science. He worked at the Faculty of Medicine, first in the Institute of Descriptive Anatomy and later as Professor of Biology and Embryology in the Department of Biology and Embryology, which he founded and led for many years. After early research on the development and histogenesis of muscles, professor Godlewski's scientific interests focused on regeneration and mechanisms regulating the process of fertilization, as well as early embryo development, blastulation and gastrulation. He was also interested in the origin of the primary differentiating cells in regenerates. He postulated the importance of epithelial tissue in this process and was the first to point out the change in the function, organization and role of the cells under the influence of external stimuli. Investigating fertilization and early development, he focused on the cooperation between the nucleus and the cytoplasm in the regulation of the early stages of development. Godlewski was also the author of the theory of migration of the inherited substances from the nucleus to the cytoplasm and, after their processing, from the cytoplasm to the nucleus. His works were never fragmentary, but always synthetical attempts at explaining important issues relating to the mechanisms of development. In 1936 Professor Godlewski was awarded the title of Member of the Pontifica Accademia delle Scienze. Apart from doing research and teaching, Emil Godlewski devoted a lot of time to social issues, especially those connected to medicine. When Poland regained independence after World War I, he actively participated in the reopening of the Jagiellonian University.

Proposal for a community-based disaster management curriculum for medical school undergraduates in Saudi Arabia.

PubMed

Bajow, Nidaa; Djalali, Ahmadreza; Ingrassia, Pier Luigi; Ageely, Hussein; Bani, Ibrahim; Della Corte, Francesco

2015-01-01

Health professional preparedness is a key element of disaster response; overall there is a need for increased disaster medicine training worldwide. The objective of this study was to design and develop a curriculum in community-based disaster medicine for Saudi Arabian medical undergraduates. A structured five-step approach was used to develop a curriculum. Expert stakeholders from the Saudi Arabian and international disaster medicine communities were surveyed to determine objectives and content. Learning strategies were carefully considered to maximize participation and retention. Particular attention was paid to equipping learners with the teaching skills required to promote disaster preparedness in their local communities. The course consists of 2 weeks of classroom activities followed by 8 weeks of e-learning structured within five domains of disaster medicine. The curriculum introduces core principles in emergency medicine, public health, and disaster management. Simulations, experiential activities, case studies, and role-playing activities are all used to promote higher levels of cognitive engagement. Special content addresses the adult-learning process, and students design their own community-based seminars in disaster preparedness. The curriculum is designed to promote learning in disaster medicine. Given the paucity of disaster medicine educators in the region, student graduates of this program would be able to improve disaster preparedness in Saudi Arabia by launching their own community-based disaster preparedness initiatives. The program could also be adapted for use throughout the Middle East.

Shared Canadian Curriculum in Family Medicine (SHARC-FM): Creating a national consensus on relevant and practical training for medical students.

PubMed

Keegan, David A; Scott, Ian; Sylvester, Michael; Tan, Amy; Horrey, Kathleen; Weston, W Wayne

2017-04-01

In 2006, leaders of undergraduate family medicine education programs faced a series of increasing curriculum mandates in the context of limited time and financial resources. Additionally, it became apparent that a hidden curriculum against family medicine as a career choice was active in medical schools. The Shared Canadian Curriculum in Family Medicine was developed by the Canadian Undergraduate Family Medicine Education Directors and supported by the College of Family Physicians of Canada as a national collaborative project to support medical student training in family medicine clerkship. Its key objective is to enable education leaders to meet their educational mandates, while at the same time countering the hidden curriculum and providing a route to scholarship. The Shared Canadian Curriculum in Family Medicine is an open-access, shared, national curriculum ( www.sharcfm.ca ). It contains 23 core clinical topics (determined through a modified Delphi process) with demonstrable objectives for each. It also includes low- and medium-fidelity virtual patient cases, point-of-care learning resources (clinical cards), and assessment tools, all aligned with the core topics. French translation of the resources is ongoing. The core topics, objectives, and educational resources have been adopted by medical schools across Canada, according to their needs. The lessons learned from mounting this multi-institutional collaborative project will help others develop their own collaborative curricula. Copyright© the College of Family Physicians of Canada.

[Application of network biology on study of traditional Chinese medicine].

PubMed

Tian, Sai-Sai; Yang, Jian; Zhao, Jing; Zhang, Wei-Dong

2018-01-01

With the completion of the human genome project, people have gradually recognized that the functions of the biological system are fulfilled through network-type interaction between genes, proteins and small molecules, while complex diseases are caused by the imbalance of biological processes due to a number of gene expression disorders. These have contributed to the rise of the concept of the "multi-target" drug discovery. Treatment and diagnosis of traditional Chinese medicine are based on holism and syndrome differentiation. At the molecular level, traditional Chinese medicine is characterized by multi-component and multi-target prescriptions, which is expected to provide a reference for the development of multi-target drugs. This paper reviews the application of network biology in traditional Chinese medicine in six aspects, in expectation to provide a reference to the modernized study of traditional Chinese medicine. Copyright© by the Chinese Pharmaceutical Association.

[Integrative medicine development in China: enlightenment from Kampo medicine].

PubMed

Gao, Peng-fei

2011-10-01

Japanese Kampo medicine has made huge progress in the 300-year development, especially in Kampo education, research and development of Kampo medicinal drugs, and industrialization and internationalization of Kampo medicine in recent 30 years. Based on the study of Japanese Kampo medicine, this article discussed some characteristics of Kampo medicine. For example, the emphasis of Kampo medicine research is the effectiveness and scientificalness; classical prescriptions are the main application in Kampo medicine while it also values correspondence between prescription and syndrome as well as abdomen examination; Kampo medicine emphasized the continuity of education after graduation; international development is accelerating in the research of Kampo medicinal drugs. Such a development strategy of Kampo medicine may benefit the development of integrative medicine in China.

System of Objectified Judgement Analysis (SOJA) as a tool in rational and transparent drug-decision making.

PubMed

Janknegt, Robert; Scott, Mike; Mairs, Jill; Timoney, Mark; McElnay, James; Brenninkmeijer, Rob

2007-10-01

Drug selection should be a rational process that embraces the principles of evidence-based medicine. However, many factors may affect the choice of agent. It is against this background that the System of Objectified Judgement Analysis (SOJA) process for rational drug-selection was developed. This article describes how the information on which the SOJA process is based, was researched and processed.

[Construction of research system for processing mechanism of traditional Chinese medicine based on chemical composition transformation combined with intestinal absorption barrier].

PubMed

Sun, E; Xu, Feng-Juan; Zhang, Zhen-Hai; Wei, Ying-Jie; Tan, Xiao-Bin; Cheng, Xu-Dong; Jia, Xiao-Bin

2014-02-01

Based on practice of Epimedium processing mechanism for many years and integrated multidisciplinary theory and technology, this paper initially constructs the research system for processing mechanism of traditional Chinese medicine based on chemical composition transformation combined with intestinal absorption barrier, which to form an innovative research mode of the " chemical composition changes-biological transformation-metabolism in vitro and in vivo-intestinal absorption-pharmacokinetic combined pharmacodynamic-pharmacodynamic mechanism". Combined with specific examples of Epimedium and other Chinese herbal medicine processing mechanism, this paper also discusses the academic thoughts, research methods and key technologies of this research system, which will be conducive to systematically reveal the modem scientific connotation of traditional Chinese medicine processing, and enrich the theory of Chinese herbal medicine processing.

[Informatics, robotics and medicine].

PubMed

Carpentier, A

1999-01-01

Information technology is becoming common use in Medicine. Among the numerous applications are data processing, image analysis, 3D reconstruction, telemedicine, to mention only few of them. The interest of computers in surgical research and development is lesser known. Two examples are given: computer aided conception and simulation of physiologic systems. Robotics has been introduced more recently. There are three types of robotics corresponding to three types of use: targetting used by neural surgeons to localize tumors or anatomical structures, visualization used by general surgeons to hold and mobilize laparoscopes, instrumentation introduced more recently by cardiac surgeons to perform totally endoscopic cardiac operations. All these techniques open new ways for tomorrow "Instrumental Medicine".

Origins and canons: medicine and the history of sociology.

PubMed

Collyer, Fran

2010-01-01

Differing accounts are conventionally given of the origins of medical sociology and its parent discipline sociology. These distinct "histories" are justified on the basis that the sociological founders were uninterested in medicine, mortality and disease. This article challenges these "constructions" of the past, proposing the theorization of health not as a "late development of sociology" but an integral part of its formation. Drawing on a selection of key sociological texts, it is argued that evidence of the founders' sustained interest in the infirmities of the individual, of mortality, and in medicine, have been expunged from the historical record through processes of "canonization" and "medicalization."

Systems Pharmacology Dissecting Holistic Medicine for Treatment of Complex Diseases: An Example Using Cardiocerebrovascular Diseases Treated by TCM.

PubMed

Wang, Yonghua; Zheng, Chunli; Huang, Chao; Li, Yan; Chen, Xuetong; Wu, Ziyin; Wang, Zhenzhong; Xiao, Wei; Zhang, Boli

2015-01-01

Holistic medicine is an interdisciplinary field of study that integrates all types of biological information (protein, small molecules, tissues, organs, external environmental signals, etc.) to lead to predictive and actionable models for health care and disease treatment. Despite the global and integrative character of this discipline, a comprehensive picture of holistic medicine for the treatment of complex diseases is still lacking. In this study, we develop a novel systems pharmacology approach to dissect holistic medicine in treating cardiocerebrovascular diseases (CCDs) by TCM (traditional Chinese medicine). Firstly, by applying the TCM active ingredients screened out by a systems-ADME process, we explored and experimentalized the signed drug-target interactions for revealing the pharmacological actions of drugs at a molecule level. Then, at a/an tissue/organ level, the drug therapeutic mechanisms were further investigated by a target-organ location method. Finally, a translational integrating pathway approach was applied to extract the diseases-therapeutic modules for understanding the complex disease and its therapy at systems level. For the first time, the feature of the drug-target-pathway-organ-cooperations for treatment of multiple organ diseases in holistic medicine was revealed, facilitating the development of novel treatment paradigm for complex diseases in the future.

Systems Pharmacology Dissecting Holistic Medicine for Treatment of Complex Diseases: An Example Using Cardiocerebrovascular Diseases Treated by TCM

PubMed Central

Wang, Yonghua; Zheng, Chunli; Huang, Chao; Li, Yan; Chen, Xuetong; Wu, Ziyin; Wang, Zhenzhong; Xiao, Wei; Zhang, Boli

2015-01-01

Holistic medicine is an interdisciplinary field of study that integrates all types of biological information (protein, small molecules, tissues, organs, external environmental signals, etc.) to lead to predictive and actionable models for health care and disease treatment. Despite the global and integrative character of this discipline, a comprehensive picture of holistic medicine for the treatment of complex diseases is still lacking. In this study, we develop a novel systems pharmacology approach to dissect holistic medicine in treating cardiocerebrovascular diseases (CCDs) by TCM (traditional Chinese medicine). Firstly, by applying the TCM active ingredients screened out by a systems-ADME process, we explored and experimentalized the signed drug-target interactions for revealing the pharmacological actions of drugs at a molecule level. Then, at a/an tissue/organ level, the drug therapeutic mechanisms were further investigated by a target-organ location method. Finally, a translational integrating pathway approach was applied to extract the diseases-therapeutic modules for understanding the complex disease and its therapy at systems level. For the first time, the feature of the drug-target-pathway-organ-cooperations for treatment of multiple organ diseases in holistic medicine was revealed, facilitating the development of novel treatment paradigm for complex diseases in the future. PMID:26101539

The competency of internists in holistic global care to support healthy Indonesia 2010.

PubMed

Rudijanto, Achmad

2006-01-01

All patients are entitled to good standards of practice and care from their doctors. The improved health of all peoples is the main goal of medical education, including for the education of internal medicine registrars. The future development of the direction and goal of education, the level of competence of internal medicine specialists, and the process of learning will be related to preparing the internal medicine specialist to have global competitive advantage. Identification of general competencies is the first step in a long-term effort designed to emphasize educational outcome, for assessment in residency programs, and in the accreditation process. To achieve that competence, a variety of learning opportunities need to be provided in order that the resident can achieve the necessary knowledge, skills, attitude, and behaviors. Identification of the role and function of internal medicine specialists is needed prior to the development of the general competencies. As educational objectives, the competencies fall into two main categories: knowledge-based and performance-based. Knowledge-based competency has two components, medical knowledge (bio-science and clinical medicine) and contextual knowledge (epidemiology, health service organization, and human behavior). The performance base has two components, intellectual skills and the interpersonal skills. Besides the two main categories of educational objectives, there are behavioral objectives that residents must achieve through the educational program, to ensure that residents are able to deal with a range of prescribed clinical situations effectively, safely, humanely, and economically. The achievement of behavioral objectives will ensure, at least in part, that the doctor will implement good medical practice. The index clinical/community situations (ICS) on which the educational objectives will be based are taken from diseases and illnesses that occur in clinical and community settings. No resident can master all medicine there is to know, as there are no limits to what can be known about medicine. It is important to make choices in selecting what residents should learn by analyzing the ICS.

From big data analysis to personalized medicine for all: challenges and opportunities.

PubMed

Alyass, Akram; Turcotte, Michelle; Meyre, David

2015-06-27

Recent advances in high-throughput technologies have led to the emergence of systems biology as a holistic science to achieve more precise modeling of complex diseases. Many predict the emergence of personalized medicine in the near future. We are, however, moving from two-tiered health systems to a two-tiered personalized medicine. Omics facilities are restricted to affluent regions, and personalized medicine is likely to widen the growing gap in health systems between high and low-income countries. This is mirrored by an increasing lag between our ability to generate and analyze big data. Several bottlenecks slow-down the transition from conventional to personalized medicine: generation of cost-effective high-throughput data; hybrid education and multidisciplinary teams; data storage and processing; data integration and interpretation; and individual and global economic relevance. This review provides an update of important developments in the analysis of big data and forward strategies to accelerate the global transition to personalized medicine.

Regulation of Clinical Trials with Advanced Therapy Medicinal Products in Germany.

PubMed

Renner, Matthias; Anliker, Brigitte; Sanzenbacher, Ralf; Schuele, Silke

2015-01-01

In the European Union, clinical trials for Advanced Therapy Medicinal Products are regulated at the national level, in contrast to the situation for a Marketing Authorisation Application, in which a centralised procedure is foreseen for these medicinal products. Although based on a common understanding regarding the regulatory requirement to be fulfilled before conduct of a clinical trial with an Advanced Therapy Investigational Medicinal Product, the procedures and partly the scientific requirements for approval of a clinical trial application differ between the European Union Member States. This chapter will thus give an overview about the path to be followed for a clinical trial application and the subsequent approval process for an Advanced Therapy Investigational Medicinal Product in Germany and will describe the role of the stakeholders that are involved. In addition, important aspects of manufacturing, quality control and non-clinical testing of Advanced Therapy Medicinal Products in the clinical development phase are discussed. Finally, current and future approaches for harmonisation of clinical trial authorisation between European Union Member States are summarised.

[What is beauty? : Manifest for an aesthetic character medicine].

PubMed

Harth, W

2017-12-01

Aesthetic medicine has in recent decades attained a growing social significance and firm place in the medical profession image. In a short time, a variety of technical procedures and processes have been developed and applied by specialized physicians. A further leading medical discussion regarding the central question "What is beauty" is missing compared with the technologically innovative progress. Beauty is characterized by an individual and subjective pleasure. Social media and fashion trends exert a central influence on common beauty ideals and aesthetic medicine. In practice, the artificial intervention must accord to the individual personality. Therefore, the professional term Aesthetic Medicine is insufficient and should be replaced by "Aesthetic Character Medicine". The particular purpose is the aim of graceful aging and a sustained adequate result which outlasts the zeitgeist. This requires medical know how and clear aesthetic self-conception of the physician. "Aesthetic Character Medicine" can be realized in a discourse, with the 10-step plan presented in this article.

The chromosomal analysis of teaching: the search for promoter genes.

PubMed

Skeff, Kelley M

2007-01-01

The process of teaching is ubiquitous in medicine, both in the practice of medicine and the promotion of medical science. Yet, until the last 50 years, the process of medical teaching had been neglected. To improve this process, the research group at the Stanford Faculty Development Center for Medical Teachers developed an educational framework to assist teachers to analyze and improve the teaching process. Utilizing empirical data drawn from videotapes of actual clinical teaching and educational literature, we developed a seven-category systematic scheme for the analysis of medical teaching, identifying key areas and behaviors that could enable teachers to enhance their effectiveness. The organizational system of this scheme is similar to that used in natural sciences, such as genetics. Whereas geneticists originally identified chromosomes and ultimately individual and related genes, this classification system identifies major categories and specific teaching behaviors that can enhance teaching effectiveness. Over the past two decades, this organizational framework has provided the basis for a variety of faculty development programs for improving teaching effectiveness. Results of those programs have revealed several positive findings, including the usefulness of the methods for a wide variety of medical teachers in a variety of settings. This research indicates that the development of a framework for analysis has been, as in the natural sciences, an important way to improve the science of the art of teaching.

Introduction to the history and current status of evidence-based korean medicine: a unique integrated system of allopathic and holistic medicine.

PubMed

Yin, Chang Shik; Ko, Seong-Gyu

2014-01-01

Objectives. Korean medicine, an integrated allopathic and traditional medicine, has developed unique characteristics and has been active in contributing to evidence-based medicine. Recent developments in Korean medicine have not been as well disseminated as traditional Chinese medicine. This introduction to recent developments in Korean medicine will draw attention to, and facilitate, the advancement of evidence-based complementary alternative medicine (CAM). Methods and Results. The history of and recent developments in Korean medicine as evidence-based medicine are explored through discussions on the development of a national standard classification of diseases and study reports, ranging from basic research to newly developed clinical therapies. A national standard classification of diseases has been developed and revised serially into an integrated classification of Western allopathic and traditional holistic medicine disease entities. Standard disease classifications offer a starting point for the reliable gathering of evidence and provide a representative example of the unique status of evidence-based Korean medicine as an integration of Western allopathic medicine and traditional holistic medicine. Conclusions. Recent developments in evidence-based Korean medicine show a unique development in evidence-based medicine, adopting both Western allopathic and holistic traditional medicine. It is expected that Korean medicine will continue to be an important contributor to evidence-based medicine, encompassing conventional and complementary approaches.

[A review of the principle mythical gods in ancient greek medicine].

PubMed

Lips Castro, Walter; Urenda Arias, Catalina

2014-12-01

Like their prehistoric ancestors, the people of early civilizations lived related to the supernatural. Facing life-threatening situations, such as illness and death, people of ancient civilizations resorted to divination, prophecy, or the oracle. Regarding the curative activities of the ancient Greek civilization, there was a period in which these processes were exclusively linked to a supernatural perspective of the origin of disease. This stage of development of Greek healing practices corresponds to what might be called pre-Hippocratic Greek medicine. In ancient Greek civilization, myths exerted a strong influence on the concepts of disease and the healing processes. Although the first divine figure of Greek mythology related to medicine was Paeon, healing cults related to Apollo and Asclepius had a higher importance in tradition and Greek mythology. The Apollonian divine healing consisted in the ability to eliminate chaos and keep away evil, while in the Asclepian perspective, the role of healer was linked to specific procedures. Personal and medical skills allowed Asclepius to surpass his father and achieve his final consecration as a god of medicine.

Diagnostic imaging applications; Proceedings of the Meeting, Amsterdam, Netherlands, October 8, 9, 1984

NASA Technical Reports Server (NTRS)

Beckenbach, E. S. (Editor)

1984-01-01

It is more important than ever that engineers have an understanding of the future needs of clinical and research medicine, and that physicians know somthing about probable future developments in instrumentation capabilities. Only by maintaining such a dialog can the most effective application of technological advances to medicine be achieved. This workshop attempted to provide this kind of information transfer in the limited field of diagnostic imaging. Biomedical research at the Jet Propulsion Laboratory is discussed, taking into account imaging results from space exploration missions, as well as biomedical research tasks based in these technologies. Attention is also given to current and future indications for magnetic resonance in medicine, high speed quantitative digital microscopy, computer processing of radiographic images, computed tomography and its modern applications, position emission tomography, and developments related to medical ultrasound.

A practical guide to manuscript writing with particular relevance to the field of pediatric hospital medicine.

PubMed

Teufel, Ronald J; Andrews, Anne L; Williams, Derek J

2014-11-01

Publishing manuscripts in peer-reviewed journals, such as Hospital Pediatrics, is critical for both the academic development of practitioners in pediatric hospital medicine and the scientific advancement of our field. Understanding the purpose of scientific writing and developing a structured approach to the writing process is essential. Doing so will improve the clarity of your work and likely the ease at which your research is published and disseminated throughout the scientific community. The purposes of this article are to detail the structure of a scientific manuscript, to highlight specific writing strategies, and to provide writing tips that may help or hinder publication. Our ultimate goal is to advance the field of pediatric hospital medicine and its growing membership by promoting the dissemination of high-quality research. Copyright © 2014 by the American Academy of Pediatrics.

Facilitators' Perspectives of the Factors That Affect the Effectiveness of Problem-Based Learning Process

ERIC Educational Resources Information Center

Chan, Cecilia K. Y.

2016-01-01

Many educational researchers have established problem-based learning (PBL) as a total approach to education--both a product and a process--from a pedagogical instructional strategy to skills development to assessment. This study provides qualitative evidences from educational practitioners in various professional disciplines, namely, Medicine,…

Preappointment testing for BRAF/KIT mutation in advanced melanoma: a model in molecular data delivery for individualized medicine.

PubMed

Mounajjed, Taofic; Brown, Char L; Stern, Therese K; Bjorheim, Annette M; Bridgeman, Andrew J; Rumilla, Kandelaria M; McWilliams, Robert R; Flotte, Thomas J

2014-11-01

The emergence of individualized medicine is driven by developments in precision diagnostics, epitomized by molecular testing. Because treatment decisions are being made based on such molecular data, data management is gaining major importance. Among data management challenges, creating workflow solutions for timely delivery of molecular data has become pivotal. This study aims to design and implement a scalable process that permits preappointment BRAF/KIT mutation analysis in melanoma patients, allowing molecular results necessary for treatment plans to be available before the patient's appointment. Process implementation aims to provide a model for efficient molecular data delivery for individualized medicine. We examined the existing process of BRAF/KIT testing in melanoma patients visiting our institution for oncology consultation. We created 5 working groups, each designing a specific segment of an alternative process that would allow preappointment BRAF/KIT testing and delivery of results. Data were captured and analyzed to evaluate the success of the alternative process. For 1 year, 35 (59%) of 55 patients had prior BRAF/KIT testing. The remaining 20 patients went through the new process of preappointment testing; results were available at the time of appointment for 12 patients (overall preappointment results availability, 85.5%). The overall process averaged 13.4 ± 4.7 days. In conclusion, we describe the successful implementation of a scalable workflow solution that permits preappointment BRAF/KIT mutation analysis and result delivery in melanoma patients. This sets the stage for further applications of this model to other conditions, answering an increasing demand for robust delivery of molecular data for individualized medicine. Copyright © 2014 Elsevier Inc. All rights reserved.

"Neither of meate nor drinke, but what the Doctor alloweth": medicine amidst war and commerce in eighteenth-century Madras.

PubMed

Chakrabarti, Pratik

2006-01-01

Madras in the eighteenth century was a site of continuous warfare sparked mostly by trading interests. This paper studies how these influences of hostility and commerce shaped the medical establishment of the English East India Company. It begins by analyzing the struggle of the medical establishment to cope with military and logistical requirements; it then shows how the Coromandel trade provided a peculiar dynamic to the practice of medicine in Madras. By aligning the history of medicine with that of trade, the paper traces the parallel trajectories of intellectual and material wealth. The development of modern medicine is seen as a process of adjusting to and engaging with diverse ideas and items--sometimes co-opting them, sometimes realigning them in new modes of production.

NLM's Medical Library Resource Improvement Grant for Consortia Development: a proposed outline to simplify the application process.

PubMed

Kabler, A W

1980-01-01

The National Library of Medicine's Resource Improvement Grant for Consortia is available to assist with developing hospital library consortia, and to support the development of basic healthy information collections. In an effort to simplify the grant application process, this paper presents suggestions for writing the narrative section of the first budget-period application, using the outline in NLM's Application Instructions for Consortium Applicants. Suggestions for writing the narratives of the second budget-period application and the collection development application are also included.

Design control considerations for biologic-device combination products.

PubMed

Anderson, Dave; Liu, Roger; Anand Subramony, J; Cammack, Jon

2017-03-01

Combination products are therapeutic and diagnostic medical products that combine drugs, devices, and/or biological products with one another. Historically, biologics development involved identifying efficacious doses administered to patients intravenously or perhaps by a syringe. Until fairly recently, there has been limited focus on developing an accompanying medical device, such as a prefilled syringe or auto-injector, to enable easy and more efficient delivery. For the last several years, and looking forward, where there may be little to distinguish biologics medicines with relatively similar efficacy profiles, the biotechnology market is beginning to differentiate products by patient-focused, biologic-device based combination products. As innovative as biologic-device combination products are, they can pose considerable development, regulatory, and commercialization challenges due to unique physicochemical properties and special clinical considerations (e.g., dosing volumes, frequency, co-medications, etc.) of the biologic medicine. A biologic-device combination product is a marriage between two partners with "cultural differences," so to speak. There are clear differences in the development, review, and commercialization processes of the biologic and the device. When these two cultures come together in a combination product, developers and reviewers must find ways to address the design controls and risk management processes of both the biologic and device, and knit them into a single entity with supporting product approval documentation. Moreover, digital medicine and connected health trends are pushing the boundaries of combination product development and regulations even further. Despite an admirable cooperation between industry and FDA in recent years, unique product configurations and design features have resulted in review challenges. These challenges have prompted agency reviewers to modernize consultation processes, while at the same time, promoting development of innovative, safe and effective combination products. It remains the manufacturer's responsibility to comply with the relevant requirements and regulations, and develop good business practices that clearly describe how these practices comply with FDA's final rule (21 CFR Part 4) and aligns with the company's already established quality system. Copyright © 2017 Elsevier B.V. All rights reserved.

Reflections on market access for personalized medicine: recommendations for Europe.

PubMed

Payne, Katherine; Annemans, Lieven

2013-01-01

This article aims to provide an overview of the current literature focusing on the reimbursement of personalized medicine across the European Union. The article starts by describing types of perspectives that are possible (general public, patient, payer, provider, service commissioner, and policymaker). The description of perspectives also explains the importance of understanding the different possible decision criteria and processes from the various perspectives by taking into account budget constraints. The article then focuses on an example of personalized medicine, namely, the use of companion diagnostic-medicine combinations, to describe the role of reimbursement/payer agencies across the European Union to control the introduction and coverage of such companion diagnostic-medicine technologies. The article touches on the strategic challenges and the use of economic evidence to introduce personalized medicine from a health policy perspective. The article also draws on empirical studies that have explored patients' and clinicians' views of examples of personalized medicine to illustrate the challenges for developing patient-centered and timely health care services. Copyright © 2013, International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc.

Biobanking for Personalized Medicine.

PubMed

Liu, Angen; Pollard, Kai

2015-01-01

A biobank is an entity that collects, processes, stores, and distributes biospecimens and relevant data for use in basic, translational, and clinical research. Biobanking of high-quality human biospecimens such as tissue, blood and other bodily fluids along with associated patient clinical information provides a fundamental scientific infrastructure for personalized medicine. Identification of biomarkers that are specifically associated with particular medical conditions such as cancer, cardiovascular disease and neurological disorders are useful for early detection, prevention, and treatment of the diseases. The ability to determine individual tumor biomarkers and to use those biomarkers for disease diagnosis, prognosis and prediction of response to therapy is having a very significant impact on personalized medicine and is rapidly changing the way clinical care is conducted. As a critical requirement for personalized medicine is the availability of a large collection of patient samples with well annotated patient clinical and pathological data, biobanks thus play an important role in personalized medicine advancement. The goal of this chapter is to explore the role of biobanks in personalized medicine and discuss specific needs regarding biobank development for translational and clinical research, especially for personalized medicine advancement.

Combating poor-quality anti-malarial medicines: a call to action.

PubMed

Bassat, Quique; Tanner, Marcel; Guerin, Philippe J; Stricker, Kirstin; Hamed, Kamal

2016-06-01

The circulation of poor-quality medicines continues to undermine the fight against many life-threatening diseases. Anti-malarial medicines appear to have been particularly compromised and present a major public health threat in malaria-endemic countries, negatively affecting individuals and their communities. Concerted collaborative efforts are required from global, regional and national organizations, involving the public and private sectors, to address the problem. While many initiatives are underway, a number of unmet needs deserve urgent and increased multisector attention. At the global level, there is a need for an international public health legal framework or treaty on poor-quality medicines, with statutes suitable for integration into national laws. In addition, increased international efforts are required to strengthen the governance of global supply chains and enhance cooperation between national medicine regulation authorities and law enforcement bodies. Increased investment is needed in innovative technologies that will enable healthcare teams to detect poor-quality medicines at all levels of the supply chain. At the regional level, a number of initiatives would be beneficial-key areas are standardization, simplification, and reciprocal recognition of registration processes and development of quality control capacity in regional centres of excellence that are better aligned with public health needs; improved surveillance methods and creation of a framework for compulsory and transparent reporting of poor-quality medicines; additional support for national medicine regulation authorities and other national partner authorities; and an increase in support for regional laboratories to boost their capabilities in detecting poor-quality medicines. It is vital that all stakeholders involved in efforts against poor-quality anti-malarial medicines extend and strengthen their actions in these critical areas and thus effectively support global health development and malaria elimination programmes.

Puncturing the myths of acupuncture.

PubMed

Mallory, Molly J; Do, Alexander; Bublitz, Sara E; Veleber, Susan J; Bauer, Brent A; Bhagra, Anjali

2016-09-01

Acupuncture is a widely practiced system of medicine that has been in place for thousands of years. Consumer interest and use of acupuncture are becoming increasingly popular in the United States, as it is used to treat a multitude of symptoms and disease processes as well as to maintain health and prevent illness. A growing body of evidence increasingly validates the practice of acupuncture. Further developing scientific data will play an important role in the future of acupuncture and other complementary and alternative medicines in public health. Acupuncture is commonly used concurrently with conventional medicine. Although acupuncture is embraced by consumers and medical professionals, misconceptions abound. We have explored and dispelled ten misconceptions common to the practice of acupuncture, utilizing an evidence-based approach. As the trend of merging conventional medical care with acupuncture treatment grows, it is important to develop a conceptual model of integrative medicine. Using a scientific evidence approach will create a structure from which to begin and grow confidence among conventional medical providers. Acupuncture is a safe and effective modality when performed properly by trained professionals. Educating both the consumer and medical community is important to enable appropriate and evidence-based applications of acupuncture and integration with conventional medicine for high-quality patient care.

Applying systems biology to biomedical research and health care: a précising definition of systems medicine.

PubMed

Schleidgen, Sebastian; Fernau, Sandra; Fleischer, Henrike; Schickhardt, Christoph; Oßa, Ann-Kristin; Winkler, Eva C

2017-11-21

Systems medicine has become a key word in biomedical research. Although it is often referred to as P4-(predictive, preventive, personalized and participatory)-medicine, it still lacks a clear definition and is open to interpretation. This conceptual lack of clarity complicates the scientific and public discourse on chances, risks and limits of Systems Medicine and may lead to unfounded hopes. Against this background, our goal was to develop a sufficiently precise and widely acceptable definition of Systems Medicine. In a first step, PubMed was searched using the keyword "systems medicine". A data extraction tabloid was developed putting forward a means/ends-division. Full-texts of articles containing Systems Medicine in title or abstract were screened for definitions. Definitions were extracted; their semantic elements were assigned as either means or ends. To reduce complexity of the resulting list, summary categories were developed inductively. In a second step, we applied six criteria for adequate definitions (necessity, non-circularity, non-redundancy, consistency, non-vagueness, and coherence) to these categories to derive a so-called précising definition of Systems Medicine. We identified 185 articles containing the term Systems Medicine in title or abstract. 67 contained at least one definition of Systems Medicine. In 98 definitions, we found 114 means and 132 ends. From these we derived the précising definition: Systems Medicine is an approach seeking to improve medical research (i.e. the understanding of complex processes occurring in diseases, pathologies and health states as well as innovative approaches to drug discovery) and health care (i.e. prevention, prediction, diagnosis and treatment) through stratification by means of Systems Biology (i.e. data integration, modeling, experimentation and bioinformatics). Our study also revealed the visionary character of Systems Medicine. Our insights, on the one hand, allow for a realistic identification of actual ethical as well as legal issues arising in the context of Systems Medicine and, in consequence, for a realistic debate of questions concerning its matter and (future) handling. On the other hand, they help avoiding unfounded hopes and unrealistic expectations. This especially holds for goals like improving patient participation which are intensely debated in the context of Systems Medicine, however not implied in the concept.

[Big data from clinical routine].

PubMed

Mansmann, U

2018-04-01

Over the past 100 years, evidence-based medicine has undergone several fundamental changes. Through the field of physiology, medical doctors were introduced to the natural sciences. Since the late 1940s, randomized and epidemiological studies have come to provide the evidence for medical practice, which led to the emergence of clinical epidemiology as a new field in the medical sciences. Within the past few years, big data has become the driving force behind the vision for having a comprehensive set of health-related data which tracks individual healthcare histories and consequently that of large populations. The aim of this article is to discuss the implications of data-driven medicine, and to examine how it can find a place within clinical care. The EU-wide discussion on the development of data-driven medicine is presented. The following features and suggested actions were identified: harmonizing data formats, data processing and analysis, data exchange, related legal frameworks and ethical challenges. For the effective development of data-driven medicine, pilot projects need to be conducted to allow for open and transparent discussion on the advantages and challenges. The Federal Ministry of Education and Research ("Bundesministerium für Bildung und Forschung," BMBF) Arthromark project is an important example. Another example is the Medical Informatics Initiative of the BMBF. The digital revolution affects clinic practice. Data can be generated and stored in quantities that are almost unimaginable. It is possible to take advantage of this for development of a learning healthcare system if the principles of medical evidence generation are integrated into innovative IT-infrastructures and processes.

Information management to enable personalized medicine: stakeholder roles in building clinical decision support.

PubMed

Downing, Gregory J; Boyle, Scott N; Brinner, Kristin M; Osheroff, Jerome A

2009-10-08

Advances in technology and the scientific understanding of disease processes are presenting new opportunities to improve health through individualized approaches to patient management referred to as personalized medicine. Future health care strategies that deploy genomic technologies and molecular therapies will bring opportunities to prevent, predict, and pre-empt disease processes but will be dependent on knowledge management capabilities for health care providers that are not currently available. A key cornerstone to the potential application of this knowledge will be effective use of electronic health records. In particular, appropriate clinical use of genomic test results and molecularly-targeted therapies present important challenges in patient management that can be effectively addressed using electronic clinical decision support technologies. Approaches to shaping future health information needs for personalized medicine were undertaken by a work group of the American Health Information Community. A needs assessment for clinical decision support in electronic health record systems to support personalized medical practices was conducted to guide health future development activities. Further, a suggested action plan was developed for government, researchers and research institutions, developers of electronic information tools (including clinical guidelines, and quality measures), and standards development organizations to meet the needs for personalized approaches to medical practice. In this article, we focus these activities on stakeholder organizations as an operational framework to help identify and coordinate needs and opportunities for clinical decision support tools to enable personalized medicine. This perspective addresses conceptual approaches that can be undertaken to develop and apply clinical decision support in electronic health record systems to achieve personalized medical care. In addition, to represent meaningful benefits to personalized decision-making, a comparison of current and future applications of clinical decision support to enable individualized medical treatment plans is presented. If clinical decision support tools are to impact outcomes in a clear and positive manner, their development and deployment must therefore consider the needs of the providers, including specific practice needs, information workflow, and practice environment.

Information management to enable personalized medicine: stakeholder roles in building clinical decision support

PubMed Central

2009-01-01

Background Advances in technology and the scientific understanding of disease processes are presenting new opportunities to improve health through individualized approaches to patient management referred to as personalized medicine. Future health care strategies that deploy genomic technologies and molecular therapies will bring opportunities to prevent, predict, and pre-empt disease processes but will be dependent on knowledge management capabilities for health care providers that are not currently available. A key cornerstone to the potential application of this knowledge will be effective use of electronic health records. In particular, appropriate clinical use of genomic test results and molecularly-targeted therapies present important challenges in patient management that can be effectively addressed using electronic clinical decision support technologies. Discussion Approaches to shaping future health information needs for personalized medicine were undertaken by a work group of the American Health Information Community. A needs assessment for clinical decision support in electronic health record systems to support personalized medical practices was conducted to guide health future development activities. Further, a suggested action plan was developed for government, researchers and research institutions, developers of electronic information tools (including clinical guidelines, and quality measures), and standards development organizations to meet the needs for personalized approaches to medical practice. In this article, we focus these activities on stakeholder organizations as an operational framework to help identify and coordinate needs and opportunities for clinical decision support tools to enable personalized medicine. Summary This perspective addresses conceptual approaches that can be undertaken to develop and apply clinical decision support in electronic health record systems to achieve personalized medical care. In addition, to represent meaningful benefits to personalized decision-making, a comparison of current and future applications of clinical decision support to enable individualized medical treatment plans is presented. If clinical decision support tools are to impact outcomes in a clear and positive manner, their development and deployment must therefore consider the needs of the providers, including specific practice needs, information workflow, and practice environment. PMID:19814826

Partnerships in global health and collaborative governance: lessons learnt from the Division of Tropical and Humanitarian Medicine at the Geneva University Hospitals.

PubMed

Beran, David; Aebischer Perone, Sigiriya; Alcoba, Gabriel; Bischoff, Alexandre; Bussien, Claire-Lise; Eperon, Gilles; Hagon, Olivier; Heller, Olivia; Jacquerioz Bausch, Frédérique; Perone, Nicolas; Vogel, Thomas; Chappuis, François

2016-04-29

In 2007 the "Crisp Report" on international partnerships increased interest in Northern countries on the way their links with Southern partners operated. Since its establishment in 2007 the Division of Tropical and Humanitarian Medicine at the Geneva University Hospitals has developed a variety of partnerships. Frameworks to assess these partnerships are needed and recent attention in the field of public management on collaborative governance may provide a useful approach for analyzing international collaborations. Projects of the Division of Tropical and Humanitarian Medicine were analyzed by collaborators within the Division using the model proposed by Emerson and colleagues for collaborative governance, which comprises different components that assess the collaborative process. International projects within the Division of Tropical and Humanitarian Medicine can be divided into four categories: Human resource development; Humanitarian response; Neglected Tropical Diseases and Noncommunicable diseases. For each of these projects there was a clear leader from the Division of Tropical and Humanitarian Medicine as well as a local counterpart. These individuals were seen as leaders both due to their role in establishing the collaboration as well as their technical expertise. Across these projects the actual partners vary greatly. This diversity means a wide range of contributions to the collaboration, but also complexity in managing different interests. A common definition of the collaborative aims in each of the projects is both a formal and informal process. Legal, financial and administrative aspects of the collaboration are the formal elements. These can be a challenge based on different administrative requirements. Friendship is part of the informal aspects and helps contribute to a relationship that is not exclusively professional. Using collaborative governance allows the complexity of managing partnerships to be presented. The framework used highlights the process of establishing collaborations, which is an element often negated by other more traditional models used in international partnerships. Applying the framework to the projects of the Division of Tropical and Humanitarian Medicine highlights the importance of shared values and interests, credibility of partners, formal and informal methods of management as well as friendship.

[Suggestions to strengthen quality management of herbal decoction pieces--based on production chain of herbal decoction pieces].

PubMed

Liu, Yan; Nie, Qing; Chen, Jing

2015-08-01

With the development of society and the improvement of people's living standards, the effect of Chinese medicine in treatment and health care is more and more prominent. The herbal decoction pieces are the important part of Chinese medicine,it can be applied directly to clinical treatment and it's also the raw material of Chinese patent medicine. Therefore, the quality of herbal decoction pieces is quite important. The parts of the production of herbal decoction pieces are numerous, and there are possibilities of adverse effects on the quality of the herbal decoction pieces in every part. In this paper, we based on the production chain of herbal decoction pieces, analyzed the main problem that affect the quality of herbal decoction pieces in the part of selection of Chinese herbal medicines, planting, purchasing, processing, packaging, storage and transport, such as the poor quality of seed and seedlings of plant-based Chinese medicines, some plants left their place of origin and have been introduced in the place that is not suitable for this kind of plant, the insufficient growth time and the excessive harmful substances. The purchasers and the accepters lack of professional knowledge and professional ethics. The mechanism of processing is not clear, the standards can not be uniformed, and lack of qualified person in processing, etc. So we suggest: intensify the basic research of key scientific issues. Improve the quality of persons who work in herbal decoction pieces; Establish an "integration" mode of operation in herbal decoction pieces enterprise; Breeding high quality plant resources, establish the large-scale planting basement; Make the packing of herbal decoction pieces standard; Establish the modernization traditional Chinese medicine logistics enterprise.

Critical Care Delivery: The Importance of Process of Care and ICU Structure to Improved Outcomes: An Update From the American College of Critical Care Medicine Task Force on Models of Critical Care.

PubMed

Weled, Barry J; Adzhigirey, Lana A; Hodgman, Tudy M; Brilli, Richard J; Spevetz, Antoinette; Kline, Andrea M; Montgomery, Vicki L; Puri, Nitin; Tisherman, Samuel A; Vespa, Paul M; Pronovost, Peter J; Rainey, Thomas G; Patterson, Andrew J; Wheeler, Derek S

2015-07-01

In 2001, the Society of Critical Care Medicine published practice model guidelines that focused on the delivery of critical care and the roles of different ICU team members. An exhaustive review of the additional literature published since the last guideline has demonstrated that both the structure and process of care in the ICU are important for achieving optimal patient outcomes. Since the publication of the original guideline, several authorities have recognized that improvements in the processes of care, ICU structure, and the use of quality improvement science methodologies can beneficially impact patient outcomes and reduce costs. Herein, we summarize findings of the American College of Critical Care Medicine Task Force on Models of Critical Care: 1) An intensivist-led, high-performing, multidisciplinary team dedicated to the ICU is an integral part of effective care delivery; 2) Process improvement is the backbone of achieving high-quality ICU outcomes; 3) Standardized protocols including care bundles and order sets to facilitate measurable processes and outcomes should be used and further developed in the ICU setting; and 4) Institutional support for comprehensive quality improvement programs as well as tele-ICU programs should be provided.

Management of medicinally useful plants by European migrants in South America.

PubMed

Kujawska, Monika; Pardo-de-Santayana, Manuel

2015-08-22

Using the example of Polish migrants living in the subtropics of Argentina, we attempt to expand knowledge about migrant strategies for retaining their agency in medicinal plant procurement. Is to state which environments play a pivotal role as a source of medicinal plants for the study community, and if a gradient of relevance exists in the exploitation of medicinally useful species between the most proximate and the most distant habitats. We particularly aim to answer the following questions: (1) if Polish migrants have changed their patterns of obtaining medicinal plants during the migratory process; and (2) if the choice of strategies for medicinal plants depends on: (a) the degree of floristic and environmental similarity between the home and host country; (b) the perception and usefulness of certain environments as a source of medicinal plants; (c) the degree of contact with the local population in the host country, and/or (d) the degree of contact between migrants and their homeland. The analysis is grounded in data from different types of interviews and a homegarden inventory addressed to 72 study participants. Voucher specimens of species mentioned were gathered and identified. Two indices were used as proxy measures: (1) the number of species obtained from each habitat, and (2) the number of citations for both modes and places of obtaining medicinal plants. Due to different flora found in Argentina, Polish migrants could reconstruct only bits and pieces of their native pharmacopoeia. They could not acquire medicinal plants either from relatives in Poland or via importation. Therefore they had to develop new strategies for securing medicinal resources. During the migratory process, Poles in Misiones changed forms and places of obtaining medicinal plants. Cultivated species from homegardens play the most important role, while in the native country homegarden species were used sparsely. The second most important environment for medicinal plant procurement is the forest, whose exploitation was increased by contact with local mestizos and indigenous groups. This study clearly shows that traditional knowledge can be adaptive and resilient. New species have been selected and incorporated from mestizos, and indigenous people, and at the same time the use of some legacy plants has been preserved. The importance of home gardens as a venue for medicinal plants is another facet of this adaptive process. Traditional knowledge is resilient too, because despite the many changes that have occurred, Polish people have maintained phytotherapy as their preferred form of treating ailments, and managed to retain certain species brought from Europe as the most relevant. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

Overview of the European Medicines Agency's Development of Product-Specific Bioequivalence Guidelines.

PubMed

Sullivan, Jane O'; Blake, Kevin; Berntgen, Michael; Salmonson, Tomas; Welink, Jan

2017-12-05

The European Medicines Agency's (EMA) product-specific bioequivalence guidelines outline harmonized regulatory requirements for studies to demonstrate bioequivalence for products that may have particular needs due to their pharmacokinetics, in addition to those outlined in general guidance. As such they are potentially very useful to the pharmaceutical industry in the development of generic medicinal products and to regulatory authorities for harmonized decision-making. Since their introduction in 2013, EMA product-specific bioequivalence guidelines continue to increase in number, and as of June 2017, encompass a number of different pharmacotherapeutic groups and pharmaceutical forms. This article further elucidates the processes involved for stakeholders and reviews the Agency's experience with the development of these guidelines, including the scientific issues witnessed with their advancement. A comparison with the United States Food and Drug Administration approach to similar guidelines is also provided. © 2017 The Authors Clinical Pharmacology & Therapeutics published by Wiley Periodicals, Inc. on behalf of American Society for Clinical Pharmacology and Therapeutics.

Driving personalized medicine: capturing maximum net present value and optimal return on investment.

PubMed

Roth, Mollie; Keeling, Peter; Smart, Dave

2010-01-01

In order for personalized medicine to meet its potential future promise, a closer focus on the work being carried out today and the foundation it will provide for that future is imperative. While big picture perspectives of this still nascent shift in the drug-development process are important, it is more important that today's work on the first wave of targeted therapies is used to build specific benchmarking and financial models against which further such therapies may be more effectively developed. Today's drug-development teams need a robust tool to identify the exact drivers that will ensure the successful launch and rapid adoption of targeted therapies, and financial metrics to determine the appropriate resource levels to power those drivers. This special report will describe one such benchmarking and financial model that is specifically designed for the personalized medicine field and will explain how the use of this or similar models can help to capture the maximum net present value of targeted therapies and help to realize optimal return on investment.

[Research and development on efficacy of Chinese herbal compound].

PubMed

Liu, Jian-Xun; Ren, Jian-Xun; Lin, Cheng-Ren

2016-03-01

The efficacy not only is summarized by clinical effect of Chinese herbal compound on theory of traditional Chinese medicine, but also is manifested to clinical effect by interaction of many intricate chemical substances. The efficacy of Chinese herbal compound is current research focus in field of traditional Chinese medicine. By currently knowing in different aspects which included the progression in efficacy of Chinese herbal compound, symptomatic efficacy of Chinese herbal compound, the relationship between the efficacy and pharmacologic effect of Chinese herbal compound, the efficacy related pharmacodynamic substance and the evaluation of efficacy, it had been summarized mainly problems and methods in research and development process of the efficacy of Chinese herbal compound in this paper. Paper also elucidated problems that need to pay attention in research of efficacy in order to provide references for clinical and experimental studies of efficacy in Chinese herbal compound, boost research and development level of new traditional Chinese drug and facilitate modernization of traditional Chinese medicines. Copyright© by the Chinese Pharmaceutical Association.

Establishing specialty jurisdictions in medicine: the case of American obstetrics and gynaecology.

PubMed

Zetka, James R

2011-09-01

The profession of medicine has evolved into an extremely specialised occupation. Yet, recent research has neglected the intra-occupational processes influencing medical specialisation. This article aims to correct this oversight. It develops an historical account of intra-occupational factors influencing the decision to establish gynaecologic oncology as American ob/gyn's surgical subspecialty in 1972. Working within the framework initially developed by Everett C. Hughes and his students, the article examines this development as the outcome of a three-party relationship among gynaecologic oncologists, American ob/gyns, and gynaecologic pelvic surgeons. Aggressive movement by the gynaecologic pelvic surgeons challenging the established élite's identity definition for the ob/gyn specialty helped spur official recognition of gynaecologic oncology, a less threatening subspecialty. The article draws theoretical implications from the case regarding the role of a threatening other in influencing the specialisation process. © 2011 The Author. Sociology of Health & Illness © 2011 Foundation for the Sociology of Health & Illness/Blackwell Publishing Ltd.

[Significance of re-evaluation and development of Chinese herbal drugs].

PubMed

Gao, Yue; Ma, Zengchun; Zhang, Boli

2012-01-01

The research of new herbal drugs involves in new herbal drugs development and renew the old drugs. It is necessary to research new herbal drugs based on the theory of traditional Chinese medicine (TCM). The current development of famous TCM focuses on the manufacture process, quality control standards, material basis and clinical research. But system management of security evaluation is deficient, the relevant system for the safety assessment TCM has not been established. The causes of security problems, security risks, target organ of toxicity, weak link of safety evaluation, and ideas of safety evaluation are discussed in this paper. The toxicology research of chinese herbal drugs is necessary based on standard of good laboratory practices (GLP), the characteristic of Chinese herbal drugs is necessary to be fully integrated into safety evaluation. The safety of new drug research is necessary to be integrated throughout the entire process. Famous Chinese medicine safety research must be paid more attention in the future.

Specialists without spirit: limitations of the mechanistic biomedical model.

PubMed

Hewa, S; Hetherington, R W

1995-06-01

This paper examines the origin and the development of the mechanistic model of the human body and health in terms of Max Weber's theory of rationalization. It is argued that the development of Western scientific medicine is a part of the broad process of rationalization that began in sixteenth century Europe as a result of the Reformation. The development of the mechanistic view of the human body in Western medicine is consistent with the ideas of calculability, predictability, and control-the major tenets of the process of rationalization as described by Weber. In recent years, however, the limitations of the mechanistic model have been the topic of many discussions. George Engel, a leading advocate of general systems theory, is one of the leading proponents of a new medical model which includes the general quality of life, clean environment, and psychological, or spiritual stability of life. The paper concludes with consideration of the potential of Engel's proposed new model in the context of the current state of rationalization in modern industrialized society.

Development and regulation of biosimilars: current status and future challenges.

PubMed

Tsiftsoglou, Asterios S; Ruiz, Sol; Schneider, Christian K

2013-06-01

Biologic medicinal products developed via rDNA technology as recombinant protein-based medicines that have been in clinical use since the early 1980s as original biopharmaceuticals have greatly contributed to the therapy of severe metabolic and degenerative diseases. The recent expiration of the data protection or patents for most of them created opportunities for the development of copy versions of original biopharmaceuticals with similar biologic activity (termed biosimilars). Production of these new products is expected to meet worldwide demand, promote market competition, maintain the incentives for innovation, and sustain the healthcare systems. The licencing of these products, however, relies on the experience gained with the original biopharmaceuticals. Critical issues related to this class of medicinal products include their terminology (to avoid confusion with generics and non-innovator copy versions that have not been tested according to the biosimilar guidelines), manufacturing, and regulation. The European Union (EU) has been the first to establish a regulatory framework for marketing authorization application (MAA) and has named these products biosimilars, a term also recently adopted by the US FDA. Unlike the conventional, more common small molecular weight human medicines and chemical generics, protein-based medicines exhibit higher molecular weight, complexity in structure and function that can be affected by changes in the manufacturing process. Therefore, biosimilars represent a relatively heterogeneous class of medicinal products that make their regulation quite challenging. According to the current understanding in the EU, a biosimilar is a copy version of an already authorized biopharmaceutical (or reference product) with similar biologic activity, physicochemical characteristics, efficacy, and safety, based on a full comparability exercise at quality, preclinical and clinical level to ensure similar efficacy and safety. Guidance has been provided through several Committee for Medicinal Products for Human Use (CHMP) guidelines as well as individual scientific advice requested from the European Medicines Agency (EMA) by various companies for the development and regulation of biosimilars. This review is mainly focused on the current status of regulation of biosimilars in the EU as well as on future challenges lying ahead for the improvement of the requirements needed for the marketing authorization of biosimilars. Emphasis is given on the quality requirements concerning these medicinal products (biologics).

Key Lessons Learned from Moffitt's Molecular Tumor Board: The Clinical Genomics Action Committee Experience.

PubMed

Knepper, Todd C; Bell, Gillian C; Hicks, J Kevin; Padron, Eric; Teer, Jamie K; Vo, Teresa T; Gillis, Nancy K; Mason, Neil T; McLeod, Howard L; Walko, Christine M

2017-02-01

The increasing practicality of genomic sequencing technology has led to its incorporation into routine clinical practice. Successful identification and targeting of driver genomic alterations that provide proliferative and survival advantages to tumor cells have led to approval and ongoing development of several targeted cancer therapies. Within many major cancer centers, molecular tumor boards are constituted to shepherd precision medicine into clinical practice. In July 2014, the Clinical Genomics Action Committee (CGAC) was established as the molecular tumor board companion to the Personalized Medicine Clinical Service (PMCS) at Moffitt Cancer Center in Tampa, Florida. The processes and outcomes of the program were assessed in order to help others move into the practice of precision medicine. Through the establishment and initial 1,400 patients of the PMCS and its associated molecular tumor board at a major cancer center, five practical lessons of broad applicability have been learned: transdisciplinary engagement, the use of the molecular report as an aid to clinical management, clinical actionability, getting therapeutic options to patients, and financial considerations. Value to patients includes access to cutting-edge practice merged with individualized preferences in treatment and care. Genomic-driven cancer medicine is increasingly becoming a part of routine clinical practice. For successful implementation of precision cancer medicine, strategically organized molecular tumor boards are critical to provide objective evidence-based translation of observed molecular alterations into patient-centered clinical action. Molecular tumor board implementation models along with clinical and economic outcomes will define future treatment standards. The Oncologist 2017;22:144-151 Implications for Practice: It is clear that the increasing practicality of genetic tumor sequencing technology has led to its incorporation as part of routine clinical practice. Subsequently, many cancer centers are seeking to develop a personalized medicine services and/or molecular tumor board to shepherd precision medicine into clinical practice. This article discusses the key lessons learned through the establishment and development of a molecular tumor board and personalized medicine clinical service. This article highlights practical issues and can serve as an important guide to other centers as they conceive and develop their own personalized medicine services and molecular tumor boards. © AlphaMed Press 2017.

Key Lessons Learned from Moffitt's Molecular Tumor Board: The Clinical Genomics Action Committee Experience

PubMed Central

Knepper, Todd C.; Bell, Gillian C.; Hicks, J. Kevin; Padron, Eric; Teer, Jamie K.; Vo, Teresa T.; Gillis, Nancy K.; Mason, Neil T.; Walko, Christine M.

2017-01-01

Abstract Background. The increasing practicality of genomic sequencing technology has led to its incorporation into routine clinical practice. Successful identification and targeting of driver genomic alterations that provide proliferative and survival advantages to tumor cells have led to approval and ongoing development of several targeted cancer therapies. Within many major cancer centers, molecular tumor boards are constituted to shepherd precision medicine into clinical practice. Materials and Methods. In July 2014, the Clinical Genomics Action Committee (CGAC) was established as the molecular tumor board companion to the Personalized Medicine Clinical Service (PMCS) at Moffitt Cancer Center in Tampa, Florida. The processes and outcomes of the program were assessed in order to help others move into the practice of precision medicine. Results. Through the establishment and initial 1,400 patients of the PMCS and its associated molecular tumor board at a major cancer center, five practical lessons of broad applicability have been learned: transdisciplinary engagement, the use of the molecular report as an aid to clinical management, clinical actionability, getting therapeutic options to patients, and financial considerations. Value to patients includes access to cutting‐edge practice merged with individualized preferences in treatment and care. Conclusions. Genomic‐driven cancer medicine is increasingly becoming a part of routine clinical practice. For successful implementation of precision cancer medicine, strategically organized molecular tumor boards are critical to provide objective evidence‐based translation of observed molecular alterations into patient‐centered clinical action. Molecular tumor board implementation models along with clinical and economic outcomes will define future treatment standards. Implications for Practice. It is clear that the increasing practicality of genetic tumor sequencing technology has led to its incorporation as part of routine clinical practice. Subsequently, many cancer centers are seeking to develop a personalized medicine services and/or molecular tumor board to shepherd precision medicine into clinical practice. This article discusses the key lessons learned through the establishment and development of a molecular tumor board and personalized medicine clinical service. This article highlights practical issues and can serve as an important guide to other centers as they conceive and develop their own personalized medicine services and molecular tumor boards. PMID:28179575

Scorecard cardiovascular medicine. Its impact and future directions.

PubMed

Topol, E J; Califf, R M

1994-01-01

Public release of operator-specific data for cardiovascular procedures has set a new precedent, introducing the "scorecard" era. Justification exists for public disclosure, but the mechanics of appropriate data release are complex from a clinical, statistical, and logistic standpoint. Scorecard medicine may appropriately promote regionalization of medical centers and consolidation of services, but unless the process is directed effectively, it may impair the development of new treatments because of a more restrictive clinical practice environment. We propose revamping our current system to facilitate rapid and accurate access to outcome data in the local practice environment so that improvement in practice occurs on a voluntary basis rather than in response to punitive restrictions. A rational plan needs to be developed for dealing with high-risk patients, perhaps through compensation in regression models used to calculate expected outcomes, and for the start-up of novice physicians. Special provisions are needed to promote clinical research. Before procedures are done, it would be ideal to provide a full disclosure informed consent, whereby the physician reports operator-specific data and the patient's decision-making process is facilitated. Overall, appropriate implementation of scorecards could ultimately lead to a substantial improvement in the quality of U.S. cardiovascular medicine.

Biosimilar Monoclonal Antibodies for Inflammatory Bowel Disease: Current Comfort and Future Prospects.

PubMed

Gecse, Krisztina B; Lakatos, Péter L

2016-10-01

Biosimilars are biologic medicines that enter the market after a patent for an original reference product expires. The European Medicines Agency (EMA) developed a stringent legislation process for biosimilar monoclonal antibodies, whereby similarity to the reference medicinal product in terms of quality characteristics, biological activity, clinical safety and efficacy must be demonstrated. Biosimilar infliximab CT-P13 was the first biosimilar monoclonal antibody to receive EMA marketing authorization, and further biosimilar molecules are being developed. The phase I and III clinical trials were conducted in ankylosing spondylitis and rheumatoid arthritis, and the use of CT-P13 in inflammatory bowel disease (IBD) was extrapolated on the results of these trials. Medical professionals were initially concerned about the reversed engineering process, the novel legal framework and the lack of clinical data in IBD. Emerging real-world data have confirmed the similarities between CT-P13 and the reference product in terms of efficacy, safety and immunogenicity in IBD. The cost reduction represented by biosimilars promotes industry competition and improves treatment access with sustained quality of care. This article reviews the existing and emerging clinical data for CT-P13 and a future perspective on biosimilar use in IBD.

[JUSTIFICATION OF USING EQUIVALENCE OF THE INDICES OF QUALITY, SAFETY, AND EFFICACY IN DEVELOPING BIOANALOGS].

PubMed

Niyazov, R R; Goryachev, D V; Gavrishina, E V; Romodanovskii, D P; Dranitsyna, M A

2015-01-01

We describe general principles of demonstrating biosimilarity, as well as selecting the biosimilarity margins. Any change in the structure of a biological molecule can modify its functional activity. Therefore, therapeutic equivalence between a biosimilar product and the corresponding reference product cannot be demonstrated using a single criterion. To demonstrate biosimilarity between two medicinal products, their various characteristics have to be evaluated which may, directly or indirectly, justify that clinically significant differences are absent. Insufficient understanding of 6ritical quality attributes brings a risk for the biosimilar product developer. This will either increase the number of non-clinical and clinical tests and trials needed or will result in awareness that the manufacturing process needs to be improved at the late stages of development, after investing significant resources in the development process. At the same time, the specification of the biological medicinal product cannot solely ensure safety and efficacy thereof. Properly characterized and controlled manufacturing process, which ensures consistency in its attributes not adequately controlled in specifications but influencing safety and efficacy profiles and showing their relevance in non-clinical tests and clinical trials, is an additional quality assurance factor. Justification of all development strategy details, including biosimilarity margins, has to be provided each time when the development process is initiated or when proceeding to the next steps. All problems encountered by the developer have to be resolved in close communication with the regulatory authority. In order to increase the quality of investigation and developer's adherence to good practices, clinical trial results should be published in detail.

[Current topics on cancer biology and research strategies for anti-cancer traditional Chinese medicine].

PubMed

Chen, Xiu-ping; Tang, Zheng-hai; Shi, Zhe; Lu, Jin-jian; Su, Huan-xing; Chen, Xin; Wang, Yi-tao

2015-09-01

Cancer, an abnormal cell proliferation resulted from multi-factors,has the highest morbidity and mortality among all the serious diseases. Considerable progress has been made in cancer biology in recent years. Tumor immunology, cancer stem cells (CSCs), autophagy, and epithelial-mesenchymal transition (EMT) have become hot topics of interests in this area. Detailed dissection of these biological processes will provide novel directions, targets, and strategies for the pharmacological evaluation, mechanism elucidation, and new drug development of traditional Chinese medicine.

Making medicine scientific: empiricism, rationality, and quackery in mid-Victorian Britain.

PubMed

Weatherall, M W

1996-08-01

This paper discusses the strategies used to construct scientific medicine in mid-Victorian Britain. An opening section considers why it was thought desirable to create a properly scientific medicine, and outlines the empirical and rational bases of the medical establishment's projects for this. The bulk of the paper concerns an alternative approach to making medicine scientific--that put forward by certain advocates of homoeopathy--and how this approach was excluded from those arenas where scientific medicine was being created, and thereby made unscientific. This process is illustrated by the clash between homoeopathy and establishment medicine that occurred in mid-Victorian Cambridge. The final section briefly considers the complementary process of educating the public in what was properly scientific medicine, and what was not, and suggests that the processes of building boundaries to exclude competing practitioners, while keeping patients inside, created the space in which modern scientific medicine has flourished so successfully.

Women Physicians: Choosing a Career in Academic Medicine

PubMed Central

Borges, Nicole J.; Navarro, Anita M.; Grover, Amelia C.

2011-01-01

Purpose Despite recent efforts to understand the complex process of physician career development, the medical education community has a poor understanding of why, how, and when women physicians embark on a career in academic medicine. Method In 2010, the authors phone-interviewed women physicians in academic medicine regarding why, how, and when they chose an academic medicine career. Project investigators first individually and then collectively analyzed transcripts to identify themes in the data. Results Through analyzing the transcripts of the 53 interviews, the investigators identified five themes related to why women choose careers in academic medicine: fit, aspects of the academic health center environment, people, exposure, and clincial medicine. They identified five themes related to how women make the decision to enter academic medicine: change in specialty, dissatisfaction with former career, emotionality, parental influence, and decision-making styles. The authors also identified four themes regarding when women decide to enter academic medicine: as a practicing phyisican, fellow, resident, or medical student. Conclusions Choosing a career in academic medicine is greatly influenced by the environment in which one trains and by people—be they faculty, mentors, role models, or family. An interest in teaching is a primary reason women choose a career in academic medicine. Many women physicians entering acadmic medicine chose this after or during fellowship, which is when they became more aware of academic medicine as a possible career. For many women, choosing academic medicine was not necessarily an active, planned decision; rather it was serendipitous or circumstantial. PMID:22104052

Women physicians: choosing a career in academic medicine.

PubMed

Borges, Nicole J; Navarro, Anita M; Grover, Amelia C

2012-01-01

Despite recent efforts to understand the complex process of physician career development, the medical education community has a poor understanding of why, how, and when women physicians embark on careers in academic medicine. In 2010, the authors phone-interviewed women physicians in academic medicine regarding why, how, and when they chose academic medicine careers. Project investigators first individually and then collectively analyzed transcripts to identify themes in the data. Through analyzing the transcripts of the 53 interviews, the investigators identified five themes related to why women choose careers in academic medicine: fit, aspects of the academic health center environment, people, exposure, and clinical medicine. They identified five themes related to how women make the decision to enter academic medicine: change in specialty, dissatisfaction with former career, emotionality, parental influence, and decision-making styles. The authors also identified four themes regarding when women decide to enter academic medicine: as a practicing physician, fellow, resident, or medical student. Choosing a career in academic medicine is greatly influenced by the environment in which one trains and by people-be they faculty, mentors, role models, or family. An interest in teaching is a primary reason women choose a career in academic medicine. Many women physicians entering academic medicine chose to do so after or during fellowship, which is when they became more aware of academic medicine as a possible career. For many women, choosing academic medicine was not necessarily an active, planned decision; rather, it was serendipitous or circumstantial.

Space medicine research: Needs for the 21st century

NASA Technical Reports Server (NTRS)

Pepper, L. J.

1992-01-01

Space medicine research in the 21st century will continue to focus on the four major areas including: (1) expansion of the current incomplete knowledge base of clinical and subclinical physiological changes due to microgravity; (2) development of countermeasures to extend the capabilities of the human performance envelope in extended duration flights; (3) development of novel methods for delivering all aspects of a comprehensive health care system in extreme remote conditions: and (4) further research and application of systems for biological materials processing. New space transportation vehicles will place unique physiologic and human factors demands on the human system, while providing better access to platforms for materials processing. Success in meeting the demands in each of the noted research areas will require an extensive, interactive team approach. Personnel from the medical research,operational, developmental, and basic science communities will be essential to success.

Nanotechnology: the revolution of the big future with tiny medicine.

PubMed

Meetoo, Danny

The historically unprecedented developments of nanoscience and nanotechnology (NT) promise to revolutionize the diagnosis, treatment and prevention of disease and traumatic injury, to relieve pain, and to preserve and improve human health, using molecular tools and molecular knowledge of the body. This article focuses on what is known as nanomedicine, referring to a definition of NT, its historical overview and developments as well as its application to medicine. In revolutionizing the manufacturing process to a nanoscale, NT promises to resolve the problems currently faced by the human race. However, in embracing this panacea, its implications, particularly within health care, cannot be ignored. This article, therefore, provides a thought-provoking consideration of how NT is likely to impact on nursing, together with the issues likely to be encountered during the care delivery process. Finally, some of the ethical questions nurses need to debate has been raised.

Funding global emergency medicine research-from seed grants to NIH support.

PubMed

Hansoti, Bhakti; Levine, Adam; Ganti, Latha; Oteng, Rockefeller; DesRosiers, Taylor; Modi, Payal; Brown, Jeremy

2016-12-01

Funding for global health has grown significantly over the past two decades. Numerous funding opportunities for international development and research work exist; however, they can be difficult to navigate. The 2013 Academic Emergency Medicine consensus conference on global health and emergency care identified the need to strengthen global emergency care research funding, solidify existing funding streams, and expand funding sources. This piece focuses on the various federal funding opportunities available to support emergency physicians conducting international research from seed funding to large institutional grants. In particular, we focus on the application and review processes for the Fulbright and Fogarty programs, National Institutes of Health (NIH) Career development awards, and the Medical Education Partnership Initiative (MEPI), including tips and pathways through each application process. Lastly, the paper provides an index that may be used as a guide in determining whether the amount of funding provided by a grant is worth the effort in applying.

Ethical aspects of sexual medicine.

PubMed

Wagner, Gorm; Bondil, Pierre; Dabees, Khalid; Dean, John; Fourcroy, Jean; Gingell, Clive; Kingsberg, Sheryl; Kothari, Prakash; Rubio-Aurioles, Eusebio; Ugarte, Fernando; Navarrete, R Vela

2005-03-01

Ethics describe the ways in which moral life is understood. Morality comprises norms for human conduct, and addresses what is right and what is wrong. To provide a consensus-based summary of the ethical aspects of sexual medicine. Over 200 multidisciplinary specialists from 60 countries were divided into 17 consultation committees as part of a process organized by an international consultation on sexual medicine held in Paris, June 28-July 1, 2003 in close alliance with several sexual medicine organizations. Embarking on a study on ethics in sexual medicine, 10 experts from eight countries assembled over a two-year period to develop this consensus-based summary. Although ethics are recognized as subjective, expert opinion was based on grading of evidence-based medical literature, in addition to cultural and ethical considerations. The process also involved extensive internal committee discussion, public presentation, and debate. Contemporary medical practitioners provide health care for patients from many different cultures from all around the world. Thus, it is recommended that all health professionals working in sexual medicine should above all be able to demonstrate respect, understanding, and tolerance toward the differing moral worldviews of their patients and colleagues, and the societies they represent. In sexual medicine, health professionals have an obligation to respect the autonomy of any individual that they treat, regardless of that individual's religious or socio-cultural tradition, race, gender, or sexual orientation. Sexual rights are a necessary condition for sexual health. Sexual health requires a positive and respectful approach to sexuality and sexual relationships as well as the possibility of having pleasurable and safe sexual experiences, free of coercion, discrimination, and violence. For sexual health to be attained and maintained, the sexual rights of all persons must be respected, protected, and fulfilled. Additional discussion and research on ethics in sexual medicine is needed.

Traditional Japanese medicines inhibit compound action potentials in the frog sciatic nerve.

PubMed

Matsushita, Akitomo; Fujita, Tsugumi; Ohtsubo, Sena; Kumamoto, Eiichi

2016-02-03

Traditional Japanese (Kampo) medicines have a variety of clinical effects including pain alleviation, but evidence for a mechanism for their pain relief has not yet been elucidated fully. Considering that Kampo medicine contains many plant-derived chemicals having an ability to inhibit nerve action potential conduction, it is possible that this medicine inhibits nerve conduction. The purpose of the present study was to know how various Kampo medicines affect nerve conduction. We examined the effects of Kampo and crude medicines on compound action potentials (CAPs) recorded from the frog sciatic nerve by using the air-gap method. Daikenchuto, rikkosan, kikyoto, rikkunshito, shakuyakukanzoto and kakkonto concentration-dependently reduced the peak amplitude of the CAP. Among the Kampo medicines, daikenchuto was the most effective in inhibiting CAPs. Daikenchuto is composed of three kinds of crude medicine, Japanese pepper, processed ginger and ginseng radix. When the crude medicines were tested, Japanese pepper and processed ginger reduced CAP peak amplitudes, while ginseng radix hardly affected CAPs. Moreover, there was an interaction between the Japanese pepper and processed ginger activities in such that one medicine at low but not high concentrations increased the extent of the inhibition by the other one that was co-applied. Kampo medicines have an ability to inhibit nerve conduction. This action of daikenchuto is due to Japanese pepper and processed ginger but not ginseng radix, probably through an interaction between Japanese pepper and processed ginger in a manner dependent on their concentrations. Nerve conduction inhibition could contribute to at least a part of Kampo medicine's clinical effects such as pain alleviation. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

Development of youth friendly family medicine services in Bosnia and Herzegovina: protocol for a cluster randomized controlled trial.

PubMed

Haller, Dagmar M; Narring, Françoise; Chondros, Patty; Pejic, Daliborka; Sredic, Ana; Huseinagic, Senad; Perone, Nicolas; Sanci, Lena A; Meynard, Anne

2014-01-01

Young people face many barriers in accessing health services that are responsive to their needs. The World Health Organization has led a call to develop services that address these barriers, i.e. youth-friendly health services. Addressing the needs of young people is one of the priorities of Foundation fami, an organisation working in collaboration with the Swiss Federal Department of Development and Cooperation and Geneva University Hospitals to develop quality family medicine services in Bosnia and Herzegovina. This paper describes the design of a trial to assess the effectiveness of a multifaceted intervention involving family medicine teams (primary care doctors and nurses) to improve the youth-friendliness of family medicine services in Bosnia and Herzegovina. This is a stratified cluster randomised trial with a repeated cross-sectional design involving 59 health services in 10 municipalities of the canton of Zenica in Bosnia and Herzegovina. Municipalities were the unit of randomisation: five municipalities were randomised to the intervention arm and five to a wait-list control arm. Family medicine teams in the intervention arm were invited to participate in an interactive training program about youth-friendly service principles and change processes within their service. The primary outcome was the youth-friendliness of the primary care service measured using the YFHS-WHO + questionnaire, a validated tool which young people aged 15 to 24 years complete following a family medicine consultation. A total of 600 young people aged 15 to 24 years were invited to participate and complete the YFHS-WHO + questionnaire: 300 (30 per municipality) at baseline, and 300 at follow-up, three to five months after the training program. The results of this trial should provide much awaited evidence about the development of youth-friendly primary care services and inform their further development both in Bosnia and Herzegovina and worldwide. Australian New Zealand Clinical Trials Registry_ ACTRN12610000142033.

Concise Review: The U.S. Food and Drug Administration and Regenerative Medicine.

PubMed

Witten, Celia M; McFarland, Richard D; Simek, Stephanie L

2015-12-01

Regenerative medicine (RM) is a popular term for a field of scientific and medical research. There is not one universally accepted definition of RM, but it is generally taken to mean the translation of multidisciplinary biology and engineering science into therapeutic approaches to regenerate, replace, or repair tissues and organs. RM products have the potential to provide treatments for a number of unmet needs but have substantial scientific and regulatory challenges that need to be addressed for this potential to be fully realized. FDA has established formal regulatory definitions for biologics, medical devices, and combination products, as well as human cells and tissues. Regenerative medicine products regulated by FDA are classified on the basis of these definitions, and the classification forms the basis for determining the regulatory requirements to each specific product. FDA regulations are generally written to allow the agency flexibility to accommodate new scientific questions raised by novel and evolving technologies. FDA efforts to facilitate product development in this novel and promising area include working with individual sponsors, interacting with the scientific and industry communities, participating in standards development, and developing policy and guidance. Regenerative medicine is generally taken to mean the translation of multidisciplinary biology and engineering science into therapeutic approaches to regenerate, replace, or repair tissues and organs. This article provides an overview of the efforts of the U.S. Food and Drug Administration (FDA) to facilitate product development in the field commonly known was regenerative medicine. It provides an introduction to the processes by which FDA works with individual sponsors, interacts with the scientific and industry communities, participates in standards development, and develops formal FDA policy and guidance. ©AlphaMed Press.

Immunomodulatory effect of morphine: therapeutic implications.

PubMed

Dinda, Amit; Gitman, Michael; Singhal, Pravin C

2005-07-01

The immunosuppressive as well as modulatory effects of morphine have been known in clinical medicine for > 100 years. Recent developments in molecular immunology, including experiments in mu (mu) opioid receptor knockout mice has led to a better understanding of central and peripheral mechanisms involved in this process. Though there is a large volume of literature documenting adverse effects of immunosupression following the use of morphine, several reports confirm its potential usefulness as an immunomodulator. In vitro and in vivo animal experiments have demonstrated wide-spectrum effects of morphine, including anti-inflammatory, antifibrotic, antitumour, cardioprotective and renoprotective. Immunomodulation is an important field in modern medicine with rapid advancement in recent years. Though a final statement regarding the clinical relevance of morphine-induced immunomodulation cannot be made at this juncture, nevertheless, it is worthwhile to review current developments. It may encourage further clinical studies to elucidate the influence of morphine treatment on immune regulation in different specialties of medicine.

Biobanking in a Constantly Developing Medical World

PubMed Central

Ciurea, Marius Eugen; Purcaru, Stefana Oana; Tache, Daniela Elise; Tataranu, Ligia Gabriela; Lupu, Mihaela; Dricu, Anica

2013-01-01

Biobank is a very sophisticated system that consists of a programmed storage of biological material and corresponding data. Biobanks are created to be used in medical research, in clinical and translational medicine, and in healthcare. In the past 20 years, a large number of biobanks have been set up around the world, to support the modern research directions in medicine such as omix and personalized medicine. More recently, embryonic and adult stem cell banks have been developed. Stem cell banking was reported to be required for medical research as well as clinical transplant applications. The quality of the samples stored in a biobank is very important. The standardization is also important; the biological material stored in a biobank must be processed in a manner that allows compatibility with other biobanks that preserve samples in the same field. In this paper, we review some issues related to biobanks purposes, quality, harmonization, and their financial and ethical aspects. PMID:24174912

[Essential medicines and the TRIPS Agreement: collision between the right to health and intellectual property rights].

PubMed

Allard Soto, Raúl

2015-03-01

The strengthening of pharmaceutical patent protection globally puts strains on access to essential medicines. According to the present paper, this process has led to the collision of the intellectual property rights adopted in the World Trade Organization (WTO) Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement and the right to health stated in the International Covenant on Economic, Social and Cultural Rights (ICESCR). Several controversies disputed in the WTO illustrate the confrontation between countries with a powerful pharmaceutical industry and the interests of developing countries. It is concluded that the TRIPS-plus rules subscribed to by developing countries in free trade agreements which give the pharmaceutical patent holder more rights than those stipulated in the original TRIPS Agreement are incompatible with the obligations to provide access to essential medicines under the right to health of the ICESCR.

Sanguinaria canadensis: Traditional Medicine, Phytochemical Composition, Biological Activities and Current Uses

PubMed Central

Croaker, Andrew; King, Graham J.; Pyne, John H.; Anoopkumar-Dukie, Shailendra; Liu, Lei

2016-01-01

Sanguinaria canadensis, also known as bloodroot, is a traditional medicine used by Native Americans to treat a diverse range of clinical conditions. The plants rhizome contains several alkaloids that individually target multiple molecular processes. These bioactive compounds, mechanistically correlate with the plant’s history of ethnobotanical use. Despite their identification over 50 years ago, the alkaloids of S. canadensis have not been developed into successful therapeutic agents. Instead, they have been associated with clinical toxicities ranging from mouthwash induced leukoplakia to cancer salve necrosis and treatment failure. This review explores the historical use of S. canadensis, the molecular actions of the benzophenanthridine and protopin alkaloids it contains, and explores natural alkaloid variation as a possible rationale for the inconsistent efficacy and toxicities encountered by S. canadensis therapies. Current veterinary and medicinal uses of the plant are studied with an assessment of obstacles to the pharmaceutical development of S. canadensis alkaloid based therapeutics. PMID:27618894

Sanguinaria canadensis: Traditional Medicine, Phytochemical Composition, Biological Activities and Current Uses.

PubMed

Croaker, Andrew; King, Graham J; Pyne, John H; Anoopkumar-Dukie, Shailendra; Liu, Lei

2016-08-27

Sanguinaria canadensis, also known as bloodroot, is a traditional medicine used by Native Americans to treat a diverse range of clinical conditions. The plants rhizome contains several alkaloids that individually target multiple molecular processes. These bioactive compounds, mechanistically correlate with the plant's history of ethnobotanical use. Despite their identification over 50 years ago, the alkaloids of S. canadensis have not been developed into successful therapeutic agents. Instead, they have been associated with clinical toxicities ranging from mouthwash induced leukoplakia to cancer salve necrosis and treatment failure. This review explores the historical use of S. canadensis, the molecular actions of the benzophenanthridine and protopin alkaloids it contains, and explores natural alkaloid variation as a possible rationale for the inconsistent efficacy and toxicities encountered by S. canadensis therapies. Current veterinary and medicinal uses of the plant are studied with an assessment of obstacles to the pharmaceutical development of S. canadensis alkaloid based therapeutics.

Resources for development of training in public health and health managment in Eastern Europe: the Kaunas experience.

PubMed

Kalediene, Ramune

2002-01-01

The aim of this paper is to review the resources and steps required for development and evaluation of training in public health and management of public health as experienced in Kaunas University of Medicine, Lithuania. The transition from Departments of Social Medicine and Hygiene to a Faculty of Public Health of international standards requires a process of adaptation and development of human resources more than physical facilities. After restoration of independence in 1990, rapid development of training in public health was started in Lithuania. Great support was provided by the international projects Baltic Rim Partnership for Public Health (BRIMHEALTH) and European Union Trans-European Mobility Scheme for University Students (TEMPUS). Undergraduate and postgraduate training programs were successfully implemented in the Faculty of Public Health, Kaunas University of Medicine. Lithuanian experience could serve as an example of success and pitfalls in training a critical mass of professionals who should act as powerful advocates for health, promoting analysis, continuity and success of public health interventions, and health care reforms in countries in transition.

Systematic Reviews/Meta-Analyses of Integrative Medicine in Chinese Need Regulation and Monitoring Urgently and Some Suggestions for Its Solutions.

PubMed

Wang, Jia-Ying; Tian, Gui-Hua; Li, You-Ping; Wu, Tai-Xiang; Bian, Zhao-Xiang; Du, Liang; Shang, Hong-Cai

2018-02-01

With the introduction and development of evidence-based medicine in China, it has been spread rapidly in the area of integrative medicine (IM) and has become a new unique discipline. During almost 20 years, as one of the most important parts of evidence-based IM, systematic review (SR)/meta-analysis (MA) of IM have shown a good development momentum in the aspects of quantity, depth, breadth and influence, but also face the harsh situation of the uncontrolled quantity and quality, especially for SRs in Chinese. Therefore, how to supervise and standardize this area effectively becomes a problem to be solved. Based on the experience both at home and abroad, the authors put forward several kinds of solutions for laying the foundation for further development such as promoting the registration system of SR/MA of IM, effectively setting up the regulatory platform of quality and quantity, launching professional training for SR/MA reviewers, forming qualification registration, developing the data transfer and sharing platform to realize the transparency of evidence process.

[Comparative analysis between origin of cooked traditional Chinese medicine powder and modern formula granules].

PubMed

Li, Rui; Zhai, Hua-Qiang; Tian, Wei-Lan; Hou, Ji-Ru; Jin, Shi-Yuan; Wang, Yong-Yan

2016-03-01

In this study, the origin and causes of cooked traditional Chinese medicine powder were reviewed, and a comprehensive analysis was made for the time background of modern traditional Chinese medicine formula granules and the future development trend, in order to provide reference for application and promotion of traditional Chinese medicine formula granules. By reference to ancient medical books of previous dynasties, a system review was conducted for infancy, formation, maturity and transition of cooked traditional Chinese medicine powder, and a comprehensive analysis was made for the six factors of cooked traditional Chinese medicine powder's maturity in the Song Dynasty. Efforts were made to collect domestic and foreign research literatures of modern formula granules, understand the detailed development, and conduct an objective analysis of the current clinical application of modern formula granules. According to the comparative analysis for the application characteristics of cooked traditional Chinese medicine powder and modern formula granules, ①the popularity of cooked traditional Chinese medicine powder in the Song Dynasty has six factors: soaring numbers of medical students and medical practitioners, high medical expenses due to huge army, rapid population growth, frequent epidemics and increasing diseases, and insufficient finances of central and local governments. ②On the basis of clinical application characteristics of traditional Chinese medicine formula granules, traditional Chinese medicine formula granules contain extracted and concentrated effective components, which guarantee the curative effect, meet modern people's demands for "quick, simple and convenience" traditional Chinese medicine decoctions, show a relatively high cost performance; however, formula granules are restricted by their varieties and lack unified quality control standards, and single-extract formula granules have not synergy and attenuation effects of combined traditional Chinese medicine decoctions, which also restricts its clinical application and promotion. ③Both have advantages in the process of clinical application, and shall be used based on syndromes. In conclusion, traditional Chinese medicine formula granules do not have disadvantages of "difficult, complicated, turbid and disorderly" cooked traditional Chinese medicine powder, and solve such problems as "inflexibility, expensiveness, restriction, disorder and inefficacy", which is the important basis for promoting traditional Chinese medicine formula granules. Copyright© by the Chinese Pharmaceutical Association.

Mining association rule based on the diseases population for recommendation of medicine need

NASA Astrophysics Data System (ADS)

Harahap, M.; Husein, A. M.; Aisyah, S.; Lubis, F. R.; Wijaya, B. A.

2018-04-01

Selection of medicines that is inappropriate will lead to an empty result at medicines, this has an impact on medical services and economic value in hospital. The importance of an appropriate medicine selection process requires an automated way to select need based on the development of the patient's illness. In this study, we analyzed patient prescriptions to identify the relationship between the disease and the medicine used by the physician in treating the patient's illness. The analytical framework includes: (1) patient prescription data collection, (2) applying k-means clustering to classify the top 10 diseases, (3) applying Apriori algorithm to find association rules based on support, confidence and lift value. The results of the tests of patient prescription datasets in 2015-2016, the application of the k-means algorithm for the clustering of 10 dominant diseases significantly affects the value of trust and support of all association rules on the Apriori algorithm making it more consistent with finding association rules of disease and related medicine. The value of support, confidence and the lift value of disease and related medicine can be used as recommendations for appropriate medicine selection. Based on the conditions of disease progressions of the hospital, there is so more optimal medicine procurement.

Current evidence and future perspectives on the effective practice of patient-centered laboratory medicine.

PubMed

Hallworth, Mike J; Epner, Paul L; Ebert, Christoph; Fantz, Corinne R; Faye, Sherry A; Higgins, Trefor N; Kilpatrick, Eric S; Li, Wenzhe; Rana, S V; Vanstapel, Florent

2015-04-01

Systematic evidence of the contribution made by laboratory medicine to patient outcomes and the overall process of healthcare is difficult to find. An understanding of the value of laboratory medicine, how it can be determined, and the various factors that influence it is vital to ensuring that the service is provided and used optimally. This review summarizes existing evidence supporting the impact of laboratory medicine in healthcare and indicates the gaps in our understanding. It also identifies deficiencies in current utilization, suggests potential solutions, and offers a vision of a future in which laboratory medicine is used optimally to support patient care. To maximize the value of laboratory medicine, work is required in 5 areas: (a) improved utilization of existing and new tests; (b) definition of new roles for laboratory professionals that are focused on optimizing patient outcomes by adding value at all points of the diagnostic brain-to-brain cycle; (c) development of standardized protocols for prospective patient-centered studies of biomarker clinical effectiveness or extraanalytical process effectiveness; (d) benchmarking of existing and new tests in specified situations with commonly accepted measures of effectiveness; (e) agreed definition and validation of effectiveness measures and use of checklists for articles submitted for publication. Progress in these areas is essential if we are to demonstrate and enhance the value of laboratory medicine and prevent valuable information being lost in meaningless data. This requires effective collaboration with clinicians, and a determination to accept patient outcome and patient experience as the primary measure of laboratory effectiveness. © 2014 American Association for Clinical Chemistry.

Bridging medicine and biomedical technology: enhance translation of fundamental research to patient care

PubMed Central

Raff, Adam B.; Seiler, Theo G.; Apiou-Sbirlea, Gabriela

2017-01-01

The ‘Bridging medicine and biomedical technology’ special all-congress session took place for the first time at the OSA Biophotonics Congress: Optics in Life Sciences in 2017 (http://www.osa.org/enus/meetings/osa_meetings/optics_in_the_life_sciences/bridging_medicine_and_biomedical_technology_specia/). The purpose was to identify key challenges the biomedical scientists in academia have to overcome to translate their discoveries into clinical practice through robust collaborations with industry and discuss best practices to facilitate and accelerate the process. Our paper is intended to complement the session by providing a deeper insight into the concept behind the structure and the content we developed. PMID:29296473

DICOM image quantification secondary capture (DICOM IQSC) integrated with numeric results, regions, and curves: implementation and applications in nuclear medicine

NASA Astrophysics Data System (ADS)

Cao, Xinhua; Xu, Xiaoyin; Voss, Stephan

2017-03-01

In this paper, we describe an enhanced DICOM Secondary Capture (SC) that integrates Image Quantification (IQ) results, Regions of Interest (ROIs), and Time Activity Curves (TACs) with screen shots by embedding extra medical imaging information into a standard DICOM header. A software toolkit of DICOM IQSC has been developed to implement the SC-centered information integration of quantitative analysis for routine practice of nuclear medicine. Primary experiments show that the DICOM IQSC method is simple and easy to implement seamlessly integrating post-processing workstations with PACS for archiving and retrieving IQ information. Additional DICOM IQSC applications in routine nuclear medicine and clinic research are also discussed.

Development of the Gross Motor Function Classification System (1997)

ERIC Educational Resources Information Center

Morris, Christopher

2008-01-01

To address the need for a standardized system to classify the gross motor function of children with cerebral palsy, the authors developed a five-level classification system analogous to the staging and grading systems used in medicine. Nominal group process and Delphi survey consensus methods were used to examine content validity and revise the…

[Intellectual property, patents and access to medication in developing countries].

PubMed

Esteve, E

2001-01-01

Pharmaceutical industry depends on continuing research and innovation to survive. This is a highly uncertain process due to the fact that only one in 20,000 screened molecules becomes a new and effective medicine. This process takes about 10 years to complete at a cost of e 480,000 per new compound. It is absolutely mandatory that intellectual property rights be protected in order to allow for investment of revenues in research and development of new medicines destined to cure or alleviate all types of disease, including those mainly afflicting the population in developing countries. The investigative drive of pharmaceutical companies has given the sector a leadership role in the search for global health. This is a responsibility the sector acknowledges and for that reason numerous laboratories are active partners of governments, private foundations, international organizations and N.G.O.s in a myriad of initiatives focused on alleviating most urgent health needs in developing countries. However, the true and final solution of this problem will only be accomplished when the social and political issues plagueing these societies are tackled.

Development of 3D in Vitro Technology for Medical Applications

PubMed Central

Ou, Keng-Liang; Hosseinkhani, Hossein

2014-01-01

In the past few years, biomaterials technologies together with significant efforts on developing biology have revolutionized the process of engineered materials. Three dimensional (3D) in vitro technology aims to develop set of tools that are simple, inexpensive, portable and robust that could be commercialized and used in various fields of biomedical sciences such as drug discovery, diagnostic tools, and therapeutic approaches in regenerative medicine. The proliferation of cells in the 3D scaffold needs an oxygen and nutrition supply. 3D scaffold materials should provide such an environment for cells living in close proximity. 3D scaffolds that are able to regenerate or restore tissue and/or organs have begun to revolutionize medicine and biomedical science. Scaffolds have been used to support and promote the regeneration of tissues. Different processing techniques have been developed to design and fabricate three dimensional scaffolds for tissue engineering implants. Throughout the chapters we discuss in this review, we inform the reader about the potential applications of different 3D in vitro systems that can be applied for fabricating a wider range of novel biomaterials for use in tissue engineering. PMID:25299693

[Quality management in intensive care medicine].

PubMed

Martin, J; Braun, J-P

2014-02-01

Treatment of critical ill patients in the intensive care unit is tantamount to well-designed risk or quality management. Several tools of quality management and quality assurance have been developed in intensive care medicine. In addition to external quality assurance by benchmarking with regard to the intensive care medicine, peer review procedures have been established for external quality assurance in recent years. In the process of peer review of an intensive care unit (ICU), external physicians and nurses visit the ICU, evaluate on-site proceedings, and discuss with the managing team of the ICU possibilities for optimization. Furthermore, internal quality management in the ICU is possible based on the 10 quality indicators of the German Interdisciplinary Society for Intensive Care Medicine (DIVI, "Deutschen Interdisziplinären Vereinigung für Intensiv- und Notfallmedizin"). Thereby every ICU has numerous possibilities to improve their quality management system.

[Quality management in intensive care medicine].

PubMed

Martin, J; Braun, J-P

2013-09-01

Treatment of critical ill patients in the intensive care unit is tantamount to well-designed risk or quality management. Several tools of quality management and quality assurance have been developed in intensive care medicine. In addition to extern quality assurance by benchmarking with regard to the intensive care medicine, peer review procedures have been established for external quality assurance in recent years. In the process of peer review of an intensive care unit (ICU), external physicians and nurses visit the ICU, evaluate on-site proceedings, and discuss with the managing team of the ICU possibilities for optimization. Furthermore, internal quality management in the ICU is possible based on the 10 quality indicators of the German Interdisciplinary Society for Intensive Care Medicine (DIVI, "Deutschen Interdisziplinären Vereinigung für Intensiv- und Notfallmedizin"). Thereby every ICU has numerous possibilities to improve their quality management system.

The role of the pathologist in translational and personalized medicine.

PubMed

Perl, Daniel P

2007-04-01

Over the years, pathologists have served to make morphologic diagnoses for clinicians when provided with a biopsy or surgically resected tissue specimen. Traditionally, pathologists have used a series of morphologic techniques and relied on the microscopic appearance of resected tissues to determine a pathologic diagnosis and, with respect to neoplastic lesions, provide predictions of the potential growth pattern that might be anticipated. With the introduction of the techniques of molecular biology in medicine, the role of the pathologist has changed as have the tools available for characterizing pathologic specimens. With the pathologist's unique perspective on disease processes and access to tissue specimens from the operating room, he has become a key player in the area of translational and personalized medicine and the development of new approaches to diagnosis and translational research. Copyright (c) 2007 Mount Sinai School of Medicine.

Cultivation and breeding of Chinese medicinal plants in Germany.

PubMed

Heuberger, Heidi; Bauer, Rudolf; Friedl, Fritz; Heubl, Günther; Hummelsberger, Josef; Nögel, Rainer; Seidenberger, Rebecca; Torres-Londoño, Paula

2010-12-01

Chinese herbal medicine (CHM) is increasingly used in Germany and Europe. Due to the need for herbal drugs of consistent quality and reliable supply, methods for commercial field cultivation and post-harvest processing under south German conditions have been developed for selected plant species used in CHM since 1999. The project used an interdisciplinary approach covering all aspects from seed sourcing to medicinal application. This paper describes the outcome of the agricultural seed and field experiments, breeding program, botanical and chemical characterization of the experimental material, comparison of experimental and imported herbal material with respect to their pharmaceutical quality, transfer of production methods and plant material to specialized farmers, medicinal application and, finally, information for users along the chain of distribution about the benefits of the locally produced herbal material. © Georg Thieme Verlag KG Stuttgart · New York.

German MedicalTeachingNetwork (MDN) implementing national standards for teacher training.

PubMed

Lammerding-Koeppel, M; Ebert, T; Goerlitz, A; Karsten, G; Nounla, C; Schmidt, S; Stosch, C; Dieter, P

2016-01-01

An increasing demand for proof of professionalism in higher education strives for quality assurance (QA) and improvement in medical education. A wide range of teacher trainings is available to medical staff in Germany. Cross-institutional approval of individual certificates is usually a difficult and time consuming task for institutions. In case of non-acceptance it may hinder medical teachers in their professional mobility. The faculties of medicine aimed to develop a comprehensive national framework, to promote standards for formal faculty development programmes across institutions and to foster professionalization of medical teaching. Addressing the above challenges in a joint approach, the faculties set up the national MedicalTeacherNetwork (MDN). Great importance is attributed to work out nationally concerted standards for faculty development and an agreed-upon quality control process across Germany. Medical teachers benefit from these advantages due to portability of faculty development credentials from one faculty of medicine to another within the MDN system. The report outlines the process of setting up the MDN and the national faculty development programme in Germany. Success factors, strengths and limitations are discussed from an institutional, individual and general perspective. Faculties engaged in similar developments might be encouraged to transfer the MDN concept to their countries.

New drugs from old.

PubMed

2006-10-01

The NHS spends over pound10 billion each year on medicines. The use of generic (patent-expired) medicines rather than branded equivalents has a key role in containing this expenditure and ensuring best value for money. On average, 4 years after the patent of a branded medicine has expired in the UK, generic equivalents will account for around half of the drug's market and cost about a quarter as much as the original brand. This represents a potentially large loss of income and, therefore, a major concern for companies that market branded products. Consequently, many use a long-term strategy known as 'lifecycle management' to minimise loss and to maximise returns from such products. This encompasses prioritising products for development, forming strategic alliances with other companies to share resourses, and utilising legal processes to protect products. One part of this strategy is the development and intensive marketing of new formulations or derivatives of existing medicines nearing the end of their patent life. Here we highlight some key examples of the impact the marketing of such products can have on patients, prescribers and the NHS.

The economics of medicines optimization: policy developments, remaining challenges and research priorities

PubMed Central

Faria, Rita; Barbieri, Marco; Light, Kate; Elliott, Rachel A.; Sculpher, Mark

2014-01-01

Background This review scopes the evidence on the effectiveness and cost-effectiveness of interventions to improve suboptimal use of medicines in order to determine the evidence gaps and help inform research priorities. Sources of data Systematic searches of the National Health Service (NHS) Economic Evaluation Database, the Cochrane Database of Systematic Reviews and the Database of Abstracts of Reviews of Effects. Areas of agreement The majority of the studies evaluated interventions to improve adherence, inappropriate prescribing and prescribing errors. Areas of controversy Interventions tend to be specific to a particular stage of the pathway and/or to a particular disease and have mostly been evaluated for their effect on intermediate or process outcomes. Growing points Medicines optimization offers an opportunity to improve health outcomes and efficiency of healthcare. Areas timely for developing research The available evidence is insufficient to assess the effectiveness and cost-effectiveness of interventions to address suboptimal medicine use in the UK NHS. Decision modelling, evidence synthesis and elicitation have the potential to address the evidence gaps and help prioritize research. PMID:25190760

Regenerative medicine in kidney disease: where we stand and where to go.

PubMed

Borges, Fernanda T; Schor, Nestor

2017-07-22

The kidney is a complex organ with more than 20 types of specialized cells that play an important role in maintaining the body's homeostasis. The epithelial tubular cell is formed during embryonic development and has little proliferative capacity under physiological conditions, but after acute injury the kidney does have regenerative capacity. However, after repetitive or severe lesions, it may undergo a maladaptation process that predisposes it to chronic kidney injury. Regenerative medicine includes various repair and regeneration techniques, and these have gained increasing attention in the scientific literature. In the future, not only will these techniques contribute to the repair and regeneration of the human kidney, but probably also to the construction of an entire organ. New mechanisms studied for kidney regeneration and repair include circulating stem cells as mesenchymal stromal/stem cells and their paracrine mechanisms of action; renal progenitor stem cells; the leading role of tubular epithelial cells in the tubular repair process; the study of zebrafish larvae to understand the process of nephron development, kidney scaffold and its repopulation; and, finally, the development of organoids. This review elucidates where we are in terms of current scientific knowledge regarding these mechanisms and the promises of future scientific perspectives.

Nonalcoholic steatohepatitis in precision medicine: Unraveling the factors that contribute to individual variability.

PubMed

Clarke, John D; Cherrington, Nathan J

2015-07-01

There are numerous factors in individual variability that make the development and implementation of precision medicine a challenge in the clinic. One of the main goals of precision medicine is to identify the correct dose for each individual in order to maximize therapeutic effect and minimize the occurrence of adverse drug reactions. Many promising advances have been made in identifying and understanding how factors such as genetic polymorphisms can influence drug pharmacokinetics (PK) and contribute to variable drug response (VDR), but it is clear that there remain many unidentified variables. Underlying liver diseases such as nonalcoholic steatohepatitis (NASH) alter absorption, distribution, metabolism, and excretion (ADME) processes and must be considered in the implementation of precision medicine. There is still a profound need for clinical investigation into how NASH-associated changes in ADME mediators, such as metabolism enzymes and transporters, affect the pharmacokinetics of individual drugs known to rely on these pathways for elimination. This review summarizes the key PK factors in individual variability and VDR and highlights NASH as an essential underlying factor that must be considered as the development of precision medicine advances. A multifactorial approach to precision medicine that considers the combination of two or more risk factors (e.g. genetics and NASH) will be required in our effort to provide a new era of benefit for patients. Copyright © 2015 Elsevier Inc. All rights reserved.

Exploration and practice of methods and processes of evidence-based rapid review on peer review of WHO EML application.

PubMed

Li, Youping; Yu, Jiajie; Du, Liang; Sun, Xin; Kwong, Joey S W; Wu, Bin; Hu, Zhiqiang; Lu, Jing; Xu, Ting; Zhang, Lingli

2015-11-01

After 38 years of development, the procedure of selection and evaluation of the World Health Organization Essential Medicine List (WHO EML) is increasingly scientific and formal. However, peer review for the applications of World Health Organization Essential Medicine List is always required in a short period. It is necessary to build up a set of methods and processes for rapid review. We identified the process of evidenced-based rapid review on WHO EML application for peer reviews according to 11 items which were required during reporting of the peer review results of the proposals. The most important items for the rapid review of World Health Organization Essential Medicine List peer reviewers are (1) to confirm the requirements and identify the purposes; (2) to establish the research questions and translate the questions into the 'Participants, Interventions, Comparators, Outcomes, Study design' (PICOS) format; (3) to search and screen available evidence, for which high-level evidence is preferred, such as systematic reviews or meta-analyses, health technology assessment, clinical guidelines; (4) to extract data, where we extract primary information based on the purposes; (5) to synthesize data by qualitative methods, assess the quality of evidence, and compare the results; (6) to provide the answers to the applications, quality of evidences and strength of recommendations. Our study established a set of methods and processes for the rapid review of World Health Organization Essential Medicine List peer review, and our findings were used to guide the reviewers to fulfill the 19(th) World Health Organization Essential Medicine List peer review. The methods and processes were feasible and met the necessary requirements in terms of time and quality. Continuous improvement and evaluation in practice are warranted. © 2015 Chinese Cochrane Center, West China Hospital of Sichuan University and Wiley Publishing Asia Pty Ltd.

National standards in pathology education: developing competencies for integrated medical school curricula.

PubMed

Sadofsky, Moshe; Knollmann-Ritschel, Barbara; Conran, Richard M; Prystowsky, Michael B

2014-03-01

Medical school education has evolved from department-specific memorization of facts to an integrated curriculum presenting knowledge in a contextual manner across traditional disciplines, integrating information, improving retention, and facilitating application to clinical practice. Integration occurs throughout medical school using live data-sharing technologies, thereby providing the student with a framework for lifelong active learning. Incorporation of educational teams during medical school prepares students for team-based patient care, which is also required for pay-for-performance models used in accountable care organizations. To develop learning objectives for teaching pathology to medical students. Given the rapid expansion of basic science knowledge of human development, normal function, and pathobiology, it is neither possible nor desirable for faculty to teach, and students to retain, this vast amount of information. Courses teaching the essentials in context and engaging students in the learning process enable them to become lifelong learners. An appreciation of pathobiology and the role of laboratory medicine underlies the modern practice of medicine. As such, all medical students need to acquire 3 basic competencies in pathology: an understanding of disease mechanisms, integration of mechanisms into organ system pathology, and application of pathobiology to diagnostic medicine. We propose the development of 3 specific competencies in pathology to be implemented nationwide, aimed at disease mechanisms/processes, organ system pathology, and application to diagnostic medicine. Each competency will include learning objectives and a means to assess acquisition, integration, and application of knowledge. The learning objectives are designed to be a living document managed (curated) by a group of pathologists representing Liaison Committee on Medical Education-accredited medical schools nationally. Development of a coherent set of learning objectives will assist medical students nationally to gain the basic competencies in pathology necessary for clinical practice. Having national standards for competencies preserves schools' independence in specific curriculum design while assuring all students meet the evolving needs of medical practice.

Ego identity development in physicians: a cross-cultural comparison using a mixed method approach.

PubMed

Beran, Tanya N; Violato, Efrem; Faremo, Sonia; Violato, Claudio; Watt, David; Lake, Deidre

2012-05-23

The purpose of this study was to examine the career decision-making process of International Medical Graduates (IMGs). There are two main types of IMGs who apply for licensure in Canada. Canadian International Medical Graduates (CIMGs) were Canadian citizens before leaving to study medicine in a foreign country, in comparison to those non-CIMGs who had studied medicine in a foreign country before immigrating to Canada. Given that their motivations for becoming a doctor in Canada may differ, it is important to examine how they decided to become a doctor for each group separately. A total of 46 IMGs participated in a semi-structured interview - 20 were CIMGs and 26 were non-CIMGs. An iterative process of content analysis was conducted to categorize responses from five open-ended questions according to the Ego Identity Statuses theory of career decision-making. Event contingency analysis identified a significant difference between CIMGs and non-CIMGs, Fisher's exact test (1) = 18.79, p < .0001. A total of 55% of CIMGs were categorized as identity achieved and 45% as foreclosed; 100% of non-CIMGs were classified as identity foreclosed. About half of the Canadian citizens who had studied medicine in a foreign country had explored different careers before making a commitment to medicine, and half had not. No IMGs, however, who studied medicine in another country before immigrating to Canada, had explored various career opportunities before selecting medicine.

Ego identity development in physicians: a cross-cultural comparison using a mixed method approach

PubMed Central

2012-01-01

Background The purpose of this study was to examine the career decision-making process of International Medical Graduates (IMGs). There are two main types of IMGs who apply for licensure in Canada. Canadian International Medical Graduates (CIMGs) were Canadian citizens before leaving to study medicine in a foreign country, in comparison to those non-CIMGs who had studied medicine in a foreign country before immigrating to Canada. Given that their motivations for becoming a doctor in Canada may differ, it is important to examine how they decided to become a doctor for each group separately. Methods A total of 46 IMGs participated in a semi-structured interview - 20 were CIMGs and 26 were non-CIMGs. Results An iterative process of content analysis was conducted to categorize responses from five open-ended questions according to the Ego Identity Statuses theory of career decision-making. Event contingency analysis identified a significant difference between CIMGs and non-CIMGs, Fisher’s exact test (1) = 18.79, p < .0001. A total of 55% of CIMGs were categorized as identity achieved and 45% as foreclosed; 100% of non-CIMGs were classified as identity foreclosed. Conclusion About half of the Canadian citizens who had studied medicine in a foreign country had explored different careers before making a commitment to medicine, and half had not. No IMGs, however, who studied medicine in another country before immigrating to Canada, had explored various career opportunities before selecting medicine. PMID:22620975

Pharmacy student decision making in over-the-counter medicine supply: A critical incident study.

PubMed

McMillan, Sara S; Thangarajah, Thachaayini; Anderson, Claire; Kelly, Fiona

2017-09-28

Various factors influence decision making in over-the-counter (OTC) medicine consultations, yet limited studies have focused, in-depth, on the thought process of pharmacy staff. This includes pharmacy students as pharmacists-in-training. To explore the factors that influence pharmacy students' decisions in relation to OTC consultations and choice of OTC medicine/s. Semi-structured interviews using the critical incident technique were undertaken with ten pharmacy students in Australia, who also worked as part-time pharmacy staff. Nine key themes were identified to influence pharmacy student decision making in OTC consultations, including customer response, confidence and scope of practice. Product requests were reported as more challenging due to customer expectations and experiences in other pharmacies, states or countries. Although negative customer response influenced some students to supply medicines in contradiction of evidence, an overarching concern for safety meant that a medicine was only supplied if unlikely to cause harm. Students reported developing confidence in OTC decision making more from real-life practice than university training; greater confidence was identified for inquiries more frequently experienced in the pharmacy. Students perceived that customers had assumptions around support staff, and were happier to talk to students than assistants. This study further identified that OTC decision making is a complex process for pharmacy students. Additional opportunities for experiential learning within this area are suggested, such as work-based placements or in-class activities such as role-plays with simulated patients. Copyright © 2017 Elsevier Inc. All rights reserved.

Understanding the needs of department chairs in academic medicine.

PubMed

Lieff, Susan; Banack, Jeannine Girard-Pearlman; Baker, Lindsay; Martimianakis, Maria Athina; Verma, Sarita; Whiteside, Catharine; Reeves, Scott

2013-07-01

The challenges for senior academic leadership in medicine are significant and becoming increasingly complex. Adapting to the rapidly changing environment of health care and medical education requires strong leadership and management skills. This article provides empirical evidence about the intricate needs of department chairs to provide insight into the design of support and development opportunities. In an exploratory case study, 21 of 25 (84%) department chairs within a faculty of medicine at a large Canadian university participated in semistructured interviews from December 2009 to February 2010. The authors conducted an inductive thematic analysis and identified a coding structure through an iterative process of relating and grouping of emerging themes. These participants were initially often insufficiently prepared for the demands of their roles. They identified a specific set of needs. They required cultural and structural awareness to navigate their hospital and university landscapes. A comprehensive network of support was necessary for eliciting advice and exchanging information, strategy, and emotional support. They identified a critical need for infrastructure growth and development. Finally, they stressed that they needed improvement in both effective interpersonal and influence skills in order to meet their mandate. Given the complexities and emotional burden of their role, it is necessary for chairs to have a range of supports and capabilities to succeed in their roles. Their leadership effectiveness can be enhanced by providing transitional processes and supports, development, and mentoring as well as facilitating the development of communities of peers.

Evaluating Quality of Decision-Making Processes in Medicines' Development, Regulatory Review, and Health Technology Assessment: A Systematic Review of the Literature

PubMed Central

Bujar, Magdalena; McAuslane, Neil; Walker, Stuart R.; Salek, Sam

2017-01-01

Introduction: Although pharmaceutical companies, regulatory authorities, and health technology assessment (HTA) agencies have been increasingly using decision-making frameworks, it is not certain whether these enable better quality decision making. This could be addressed by formally evaluating the quality of decision-making process within those organizations. The aim of this literature review was to identify current techniques (tools, questionnaires, surveys, and studies) for measuring the quality of the decision-making process across the three stakeholders. Methods: Using MEDLINE, Web of Knowledge, and other Internet-based search engines, a literature review was performed to systematically identify techniques for assessing quality of decision making in medicines development, regulatory review, and HTA. A structured search was applied using key words and a secondary review was carried out. In addition, the measurement properties of each technique were assessed and compared. Ten Quality Decision-Making Practices (QDMPs) developed previously were then used as a framework for the evaluation of techniques identified in the review. Due to the variation in studies identified, meta-analysis was inappropriate. Results: This review identified 13 techniques, where 7 were developed specifically to assess decision making in medicines' development, regulatory review, or HTA; 2 examined corporate decision making, and 4 general decision making. Regarding how closely each technique conformed to the 10 QDMPs, the 13 techniques assessed a median of 6 QDMPs, with a mode of 3 QDMPs. Only 2 techniques evaluated all 10 QDMPs, namely the Organizational IQ and the Quality of Decision Making Orientation Scheme (QoDoS), of which only one technique, QoDoS could be applied to assess decision making of both individuals and organizations, and it possessed generalizability to capture issues relevant to companies as well as regulatory authorities. Conclusion: This review confirmed a general paucity of research in this area, particularly regarding the development and systematic application of techniques for evaluating quality decision making, with no consensus around a gold standard. This review has identified QoDoS as the most promising available technique for assessing decision making in the lifecycle of medicines and the next steps would be to further test its validity, sensitivity, and reliability. PMID:28443022

Using 3D range cameras for crime scene documentation and legal medicine

NASA Astrophysics Data System (ADS)

Cavagnini, Gianluca; Sansoni, Giovanna; Trebeschi, Marco

2009-01-01

Crime scene documentation and legal medicine analysis are part of a very complex process which is aimed at identifying the offender starting from the collection of the evidences on the scene. This part of the investigation is very critical, since the crime scene is extremely volatile, and once it is removed, it can not be precisely created again. For this reason, the documentation process should be as complete as possible, with minimum invasiveness. The use of optical 3D imaging sensors has been considered as a possible aid to perform the documentation step, since (i) the measurement is contactless and (ii) the process required to editing and modeling the 3D data is quite similar to the reverse engineering procedures originally developed for the manufacturing field. In this paper we show the most important results obtained in the experimentation.

Comprehensive Auditing in Nuclear Medicine Through the International Atomic Energy Agency Quality Management Audits in Nuclear Medicine (QUANUM) Program. Part 1: the QUANUM Program and Methodology.

PubMed

Dondi, Maurizio; Torres, Leonel; Marengo, Mario; Massardo, Teresa; Mishani, Eyal; Van Zyl Ellmann, Annare; Solanki, Kishor; Bischof Delaloye, Angelika; Lobato, Enrique Estrada; Miller, Rodolfo Nunez; Paez, Diana; Pascual, Thomas

2017-11-01

An effective management system that integrates quality management is essential for a modern nuclear medicine practice. The Nuclear Medicine and Diagnostic Imaging Section of the International Atomic Energy Agency (IAEA) has the mission of supporting nuclear medicine practice in low- and middle-income countries and of helping them introduce it in their health-care system, when not yet present. The experience gathered over several years has shown diversified levels of development and varying degrees of quality of practice, among others because of limited professional networking and limited or no opportunities for exchange of experiences. Those findings triggered the development of a program named Quality Management Audits in Nuclear Medicine (QUANUM), aimed at improving the standards of NM practice in low- and middle-income countries to internationally accepted standards through the introduction of a culture of quality management and systematic auditing programs. QUANUM takes into account the diversity of nuclear medicine services around the world and multidisciplinary contributions to the practice. Those contributions include clinical, technical, radiopharmaceutical, and medical physics procedures. Aspects of radiation safety and patient protection are also integral to the process. Such an approach ensures consistency in providing safe services of superior quality to patients. The level of conformance is assessed using standards based on publications of the IAEA and the International Commission on Radiological Protection, and guidelines from scientific societies such as Society of Nuclear Medicine and Molecular Imaging (SNMMI) and European Association of Nuclear Medicine (EANM). Following QUANUM guidelines and by means of a specific assessment tool developed by the IAEA, auditors, both internal and external, will be able to evaluate the level of conformance. Nonconformances will then be prioritized and recommendations will be provided during an exit briefing. The same tool could then be applied to assess any improvement after corrective actions are taken. This is the first comprehensive audit program in nuclear medicine that helps evaluate managerial aspects, safety of patients and workers, clinical practice, and radiopharmacy, and, above all, keeps them under control all together, with the intention of continuous improvement. Copyright © 2017. Published by Elsevier Inc.

Enhancing behavioral science education at the Ohio State University College of Medicine.

PubMed

Post, Douglas M; Stone, Linda C; Knutson, Douglas J; Gutierrez, Tamara L; Sari, Firuzan; Hudson, William A

2008-01-01

The social and behavioral sciences play key roles in patient health outcomes. Given this reality, successful development of social and behavioral science curricula in medical education is critically important to the quality of patients' lives and the effectiveness of health care delivery systems. The Institute of Medicine, in a recent report, recommended that medical schools enhance their curricula in these areas and identified four institutions as "exemplars" of social and behavioral science education. The authors describe an ongoing curriculum development and improvement process that produced one such exemplary program at The Ohio State University College of Medicine. The authors provide a historical perspective on behavioral science education, discuss issues that led to curricular change, and describe the principles and processes used to implement reform. Critical factors underlying positive change are addressed: increase active learning, recruit a core group of small-group facilitators who are primary care physicians, diversify teaching methods, support student-directed educational initiatives, enhance student-teacher relationships, centralize course administration, obtain funding, implement a faculty development program, and apply curriculum quality improvement methods. Outcome data from evaluations completed by both students and small-group physician faculty are presented, and future directions regarding further revision are outlined. The authors believe that the strategies they describe can be applied at other institutions and assist behavioral science educators who may experience the challenges typically encountered in this important field of medical education.

Medical Image Processing Server applied to Quality Control of Nuclear Medicine.

NASA Astrophysics Data System (ADS)

Vergara, C.; Graffigna, J. P.; Marino, E.; Omati, S.; Holleywell, P.

2016-04-01

This paper is framed within the area of medical image processing and aims to present the process of installation, configuration and implementation of a processing server of medical images (MIPS) in the Fundación Escuela de Medicina Nuclear located in Mendoza, Argentina (FUESMEN). It has been developed in the Gabinete de Tecnologia Médica (GA.TE.ME), Facultad de Ingeniería-Universidad Nacional de San Juan. MIPS is a software that using the DICOM standard, can receive medical imaging studies of different modalities or viewing stations, then it executes algorithms and finally returns the results to other devices. To achieve the objectives previously mentioned, preliminary tests were conducted in the laboratory. More over, tools were remotely installed in clinical enviroment. The appropiate protocols for setting up and using them in different services were established once defined those suitable algorithms. Finally, it’s important to focus on the implementation and training that is provided in FUESMEN, using nuclear medicine quality control processes. Results on implementation are exposed in this work.

Developing and pilot testing of a tool for "clinicosocial case study" assessment of community medicine residents.

PubMed

Gohel, Manisha; Singh, Uday Shankar; Bhanderi, Dinesh; Phatak, Ajay

2016-01-01

Practical and clinical skills teaching should constitute a core part of the postgraduate curriculum of Community Medicine. The clinicosocial case study is a method to enhance learners' skills but there is no generally accepted organized system of formative assessment and structured feedback to guide students. A new tool based on the principles of mini-Clinical Evaluation Exercise (mini CEX) was developed and pilot tested as a 'clinicosocial case study' assessment of community medicine residents with feedback as a core component. Ten core domains of clinicosocial skills were identified after reviewing the relevant literature and input from local experts in community medicine and medical education. We pilot tested the tool with eight faculty members to assess five residents during clinicosocial case presentations on a variety of topics. Kappa statistic and Bland Altman plots were used to assess agreement between faculty members' average assessment scores. Cronbach's alpha was used to test the internal consistency with faculty members as domains. All 95% confidence limits using the Bland-Altman method were within the predetermined limit of 2 points. The overall Kappa between two faculty members was fair ranging from 0.2 to 0.3. Qualitative feedback revealed that both faculty and residents were enthusiastic about the process but faculty suggested further standardization, while residents suggested streamlining of the process. This new assessment tool is available for objective and unbiased assessment of residents through 'clinicosocial case study,' which enriches learning through comprehensive feedback. Further validation in different settings is needed.

Developing an evidence-based methodological framework to systematically compare HTA coverage decisions: A mixed methods study.

PubMed

Nicod, Elena; Kanavos, Panos

2016-01-01

Health Technology Assessment (HTA) often results in different coverage recommendations across countries for a same medicine despite similar methodological approaches. This paper develops and pilots a methodological framework that systematically identifies the reasons for these differences using an exploratory sequential mixed methods research design. The study countries were England, Scotland, Sweden and France. The methodological framework was built around three stages of the HTA process: (a) evidence, (b) its interpretation, and (c) its influence on the final recommendation; and was applied to two orphan medicinal products. The criteria accounted for at each stage were qualitatively analyzed through thematic analysis. Piloting the framework for two medicines, eight trials, 43 clinical endpoints and seven economic models were coded 155 times. Eighteen different uncertainties about this evidence were coded 28 times, 56% of which pertained to evidence commonly appraised and 44% to evidence considered by only some agencies. The poor agreement in interpreting this evidence (κ=0.183) was partly explained by stakeholder input (ns=48 times), or by agency-specific risk (nu=28 uncertainties) and value preferences (noc=62 "other considerations"), derived through correspondence analysis. Accounting for variability at each stage of the process can be achieved by codifying its existence and quantifying its impact through the application of this framework. The transferability of this framework to other disease areas, medicines and countries is ensured by its iterative and flexible nature, and detailed description. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

Position Statement of the Israeli Society for Musculoskeletal Medicine on Intramuscular Stimulation for Myofascial Pain Syndrome-A Delphi Process.

PubMed

Ratmansky, Motti; Minerbi, Amir; Kalichman, Leonid; Kent, John; Wende, Osnat; Finestone, Aharon S; Vulfsons, Simon

2017-04-01

To develop consensus on a position paper on the use of intramuscular stimulation (IMS) for the treatment of myofascial pain syndrome (MPS) by physicians in Israel. The Israeli Society of Musculoskeletal Medicine ran a modified Delphi process to gather opinions from a multidisciplinary expert panel. Eight experts in the treatment of MPS were chosen and asked to participate, and six participated. The position paper was iterated three times. After three iterations, general consensus was reached by all six experts. The general statement that was agreed on was: "IMS is one of the preferred treatments for myofascial pain syndrome. The treatment is evidence-based, effective, safe, and inexpensive. The position of the Israeli Society of Musculoskeletal Medicine is that the treatment should be taught and used by all primary care physicians and those physicians in other areas of medicine who deal with pain in their work." The position paper is a basis for clinical work and education programs for physicians interested in a better understanding and ability to treat patients with a musculoskeletal complaint or manifestation of disease. © 2016 World Institute of Pain.

[Structure of pain management facilities in Germany : Classification of medical and psychological pain treatment services-Consensus of the Joint Commission of the Professional Societies and Organizations for Quality in Pain Medicine].

PubMed

Müller-Schwefe, G H H; Nadstawek, J; Tölle, T; Nilges, P; Überall, M A; Laubenthal, H J; Bock, F; Arnold, B; Casser, H R; Cegla, T H; Emrich, O M D; Graf-Baumann, T; Henning, J; Horlemann, J; Kayser, H; Kletzko, H; Koppert, W; Längler, K H; Locher, H; Ludwig, J; Maurer, S; Pfingsten, M; Schäfer, M; Schenk, M; Willweber-Strumpf, A

2016-06-01

On behalf of the Medical/Psychological Pain Associations, Pain Patients Alliance and the Professional Association of Pain Physicians and Psychologists, the Joint Commission of Professional Societies and Organizations for Quality in Pain Medicine, working in close collaboration with the respective presidents, has developed verifiable structural and process-related criteria for the classification of medical and psychological pain treatment facilities in Germany. Based on the established system of graded care in Germany and on existing qualifications, these criteria also argue for the introduction of a basic qualification in pain medicine. In addition to the first-ever comprehensive description of psychological pain facilities, the criteria presented can be used to classify five different levels of pain facilities, from basic pain management facilities, to specialized institutions, to the Centre for Interdisciplinary Pain Medicine. The recommendations offer binding and verifiable criteria for quality assurance in pain medicine and improved pain treatment.

[Optimization theory and practical application of membrane science technology based on resource of traditional Chinese medicine residue].

PubMed

Zhu, Hua-Xu; Duan, Jin-Ao; Guo, Li-Wei; Li, Bo; Lu, Jin; Tang, Yu-Ping; Pan, Lin-Mei

2014-05-01

Resource of traditional Chinese medicine residue is an inevitable choice to form new industries characterized of modem, environmental protection and intensive in the Chinese medicine industry. Based on the analysis of source and the main chemical composition of the herb residue, and for the advantages of membrane science and technology used in the pharmaceutical industry, especially membrane separation technology used in improvement technical reserves of traditional extraction and separation process in the pharmaceutical industry, it is proposed that membrane science and technology is one of the most important choices in technological design of traditional Chinese medicine resource industrialization. Traditional Chinese medicine residue is a very complex material system in composition and character, and scientific and effective "separation" process is the key areas of technology to re-use it. Integrated process can improve the productivity of the target product, enhance the purity of the product in the separation process, and solve many tasks which conventional separation is difficult to achieve. As integrated separation technology has the advantages of simplified process and reduced consumption, which are in line with the trend of the modern pharmaceutical industry, the membrane separation technology can provide a broad platform for integrated process, and membrane separation technology with its integrated technology have broad application prospects in achieving resource and industrialization process of traditional Chinese medicine residue. We discuss the principles, methods and applications practice of effective component resources in herb residue using membrane separation and integrated technology, describe the extraction, separation, concentration and purification application of membrane technology in traditional Chinese medicine residue, and systematically discourse suitability and feasibility of membrane technology in the process of traditional Chinese medicine resource industrialization in this paper.

Narratives in family medicine: a global perspective

PubMed Central

Gibson, Christine; Woollard, Robert; Kapoor, Videsh; Ponka, David

2017-01-01

Abstract Objective To explore the development of family medicine postgraduate training in countries with varying levels of resources at different stages of development of the discipline. Composition of the committee Since 2012, the College of Family Physicians of Canada has hosted the Besrour Conferences to reflect on its role in advancing the discipline of family medicine globally. The Besrour Narrative Working Group was conceived in 2012 at the first Besrour Conference. Their mandate was to use narrative and appreciative inquiry to gather stories of family medicine worldwide. The working group comprised members of various academic departments of family medicine in Canada and abroad who attended the conferences. Methods A consultation process with our partners from lower-middle–income countries was undertaken from 2012 to 2014. Stories were sought from each global partner institute with ties to Canadian family medicine departments. An appreciative inquiry approach was chosen to elicit narratives. Thematic analysis was used to search for common threads and important elements of success that could serve to inform other initiatives in other nations and, in turn, offer hope for greater effect. Report Sixteen narrative stories have been collected so far. These stories highlight insightful solutions, foresight, perseverance, and ultimately a steadfast belief that family medicine will improve the health system and the care provided to the citizens of each nation. Seventeen themes were elucidated by 3 independent Canadian readers. At a subsequent workshop, these themes were validated by Besrour Centre members from Canada and elsewhere. The linkage between the thematic analysis and the experiences of various schools helps to illustrate both the robustness and the usefulness of the narratives in exploring generalizable observations and the features supporting success in each institute. Conclusion If we are to understand, and contribute to, the development of family medicine throughout the world (a key objective of the Besrour Centre), we must begin to hear each others’ stories and search for ways in which our collective story can advance the discipline. PMID:28209677

Surgical and Resuscitation Capabilities for the "Next War" Based on Lessons Learned From "This War".

PubMed

Freel, David; Warr, Bradley J

2016-01-01

The Army gleaned many lessons regarding the provision of medical care to casualties during the past 14 years of combat. Using these lessons learned in the Joint Capabilities and Integration Development process and through the analysis of an integrated process action team, the Army recently approved 3 changes to medical organizations that are intended to provide trauma management farther forward on the battlefield. These changes include the substitution of an emergency medicine trained physician and emergency medicine physician assistant (PA) in lieu of a general medical officer and primary care PA within the brigade combat team; reorganization of the forward surgical team into a forward surgical and resuscitative team; and the modularization of the traditional 248 bed combat support hospital. The Army anticipates that these changes related to personnel, organizations, doctrine, and materiel will enable Army medicine to provide enhanced trauma management closer to the point of a combatant's injury. These modifications are projected to begin in fiscal year 2016.

[Structured medication management in primary care - a tool to promote medication safety].

PubMed

Mahler, Cornelia; Freund, Tobias; Baldauf, Annika; Jank, Susanne; Ludt, Sabine; Peters-Klimm, Frank; Haefeli, Walter Emil; Szecsenyi, Joachim

2014-01-01

Patients with chronic disease usually need to take multiple medications. Drug-related interactions, adverse events, suboptimal adherence, and self-medication are components that can affect medication safety and lead to serious consequences for the patient. At present, regular medication reviews to check what medicines have been prescribed and what medicines are actually taken by the patient or the structured evaluation of drug-related problems rarely take place in Germany. The process of "medication reconciliation" or "medication review" as developed in the USA and the UK aim at increasing medication safety and therefore represent an instrument of quality assurance. Within the HeiCare(®) project a structured medication management was developed for general practice, with medical assistants playing a major role in the implementation of the process. Both the structured medication management and the tools developed for the medication check and medication counselling will be outlined in this article; also, findings on feasibility and acceptance in various projects and experiences from a total of 200 general practices (56 HeiCare(®), 29 HiCMan,115 PraCMan) will be described. The results were obtained from questionnaires and focus group discussions. The implementation of a structured medication management intervention into daily routine was seen as a challenge. Due to the high relevance of medication reconciliation for daily clinical practice, however, the checklists - once implemented successfully - have been applied even after the end of the project. They have led to the regular review and reconciliation of the physicians' documentation of the medicines prescribed (medication chart) with the medicines actually taken by the patient. Copyright © 2013. Published by Elsevier GmbH.

Personalized medicine and the role of health economics and outcomes research: issues, applications, emerging trends, and future research.

PubMed

O'Donnell, John C

2013-01-01

The decade since the completion of the sequencing of the human genome has witnessed significant advances in the incorporation of genomic information in diagnostic, treatment, and reimbursement practices. Indeed, as case in point, there are now several dozen commercially available genomic tests routinely applied across a wide range of disease states in predictive or prognostic applications. Moreover, many involved in the advancement of personalized medicine would view emerging approaches to stratify patients in meaningful ways beyond genomic information as a signal of the progress made. Yet despite these advances, there remains a general sense of dissatisfaction about the progress of personalized medicine in terms of its contribution to the drug development process, to the efficiency and effectiveness of health care delivery, and ultimately to the provision of the right treatment to the right patient at the right time. Academicians, payers, and manufacturers alike are struggling not only with how to embed the new insights that personalized medicine promises but also with the fundamental issues of application in early drug development, implications for health technology assessment, new demands on traditional health economic and outcomes research methods, and implications for reimbursement and access. In fact, seemingly prosaic issues such as the definition and composition of the term "personalized medicine" are still unresolved. Regardless of these issues, practitioners are increasingly compelled to find practical solutions to the challenges and opportunities presented by the evolving face of personalized medicine today. Accordingly, the articles comprising this Special Issue offer applied perspectives geared toward professionals and policymakers in the field grappling with developing, assessing, implementing, and reimbursing personalized medicine approaches. Starting with a framework with which to characterize personalized medicine, this Special Issue proceeds to illuminate issues related to the intersection of personalized medicine and comparative effectiveness; use of personalized medicine approaches in drug development; methodological challenges; and payer approaches to evaluation and reimbursement of pharmacodiagnostics in the United States and Europe. It concludes with a look ahead, underscoring current controversies yet to be resolved along with their implications for further research and policy. It is hoped that these articles will help inform the daily challenges faced by the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) community as it collectively addresses what promises to be a new era in drug development and health care delivery. Copyright © 2013, International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc.

The business process management software for successful quality management and organization: A case study from the University of Split School of Medicine.

PubMed

Sapunar, Damir; Grković, Ivica; Lukšić, Davor; Marušić, Matko

2016-05-01

Our aim was to describe a comprehensive model of internal quality management (QM) at a medical school founded on the business process analysis (BPA) software tool. BPA software tool was used as the core element for description of all working processes in our medical school, and subsequently the system served as the comprehensive model of internal QM. The quality management system at the University of Split School of Medicine included the documentation and analysis of all business processes within the School. The analysis revealed 80 weak points related to one or several business processes. A precise analysis of medical school business processes allows identification of unfinished, unclear and inadequate points in these processes, and subsequently the respective improvements and increase of the QM level and ultimately a rationalization of the institution's work. Our approach offers a potential reference model for development of common QM framework allowing a continuous quality control, i.e. the adjustments and adaptation to contemporary educational needs of medical students. Copyright © 2016 by Academy of Sciences and Arts of Bosnia and Herzegovina.

Japan Report, Science and Technology.

DTIC Science & Technology

1987-02-06

cyclodextrin, which consists of natural cyclic oligosaccharides . Recently, the author and co-workers have found that methylated CD works as an effective...industry as catalysts for the production of olefin derivatives. This is quite interesting, when we compare it with the shitasu process . Research on...lasers in machin- ing and medicine, particularly in semiconductor processing . According to the Optoelectronic Industry and Technology Development

Tell Me Your Story: A Pilot Narrative Medicine Curriculum During the Medicine Clerkship.

PubMed

Chretien, Katherine C; Swenson, Rebecca; Yoon, Bona; Julian, Ricklie; Keenan, Jonathan; Croffoot, James; Kheirbek, Raya

2015-07-01

Narrative medicine educational interventions may enhance patient-centered care, yet most educational interventions do not involve actual patient-provider interactions, nor do they assess narrative competence, a key skill for its practice. An experiential narrative medicine curriculum for medical students was developed and piloted. The purpose of the study was to develop narrative competence, practice attentive listening, and stimulate reflection. Participants were third-year medicine clerkship students. The curriculum involved 1) an introductory session, 2) a patient storytelling activity, and 3) a group reflection session. For the storytelling activity, students elicited illness narratives in storytelling form from patients, listened attentively, wrote their versions of the story, and then read them back to patients. Five student focus groups were conducted between July 2011 and March 2012 (n = 31; 66%) to explore students' experiences, student-patient dynamics, challenges, and what they learned. Patient interviews (n = 17) on their experience were conducted in January 2013. Thematic analysis of the audiotaped stories of ten patients and corresponding student-written stories helped gauge narrative competence. The curriculum was found to be feasible and acceptable to both patients and students. Some patients and students were profoundly moved. Ongoing focus groups resulted in continual process improvement. Students' stories showed attainment of narrative competence.

The current status and future potential of personalized diagnostics: Streamlining a customized process.

PubMed

Richmond, Terri D

2008-01-01

Recent genetic discoveries and related developments in genomic techniques have led to the commercialization of novel diagnostic platforms for studying disease or gauging therapeutic outcomes in individual patients. This newly emerging field is called "personalized medicine," and uses the patient's genetic composition to tailor strategies for patient-specific disease detection, treatment, or prevention. Personalized diagnostic tests are used to detect patient-to-patient variations in gene or protein expression levels, which act as indicators for drug treatments or disease prognosis. In turn, medical professionals can better answer questions such as: "Who should be treated with which drug?" and "How should the treatment be administered?" The regulations governing personalized medicine can be complicated because they encompass in vitro diagnostic systems and laboratory tests as well as methods of disease treatment and patient care. Industry, academia, medicine, and the Food and Drug Administration (FDA) are all involved in the cultivation of the field: substantial collaborations between drug developers and regulatory authorities are required to consider and shape emerging regulations as personalized drug strategies mature. Some of the regulatory issues identified by industry and the FDA about personalized medicine and personalized diagnostics will be addressed. In addition, relevant collaborations, advances, and current and draft regulatory guidances will be discussed with respect to the future of personalized medicine.

Clinical practice guidelines for the treatment of primary liver cancer with integrative traditional Chinese and Western medicine.

PubMed

Ling, Chang-Quan; Fan, Jia; Lin, Hong-Sheng; Shen, Feng; Xu, Zhen-Ye; Lin, Li-Zhu; Qin, Shu-Kui; Zhou, Wei-Ping; Zhai, Xiao-Feng; Li, Bai; Zhou, Qing-Hui

2018-05-17

Traditional Chinese medicine (TCM) is an important part of the treatment of primary liver cancer (PLC) in China; however, the current instructions for the integrative use of traditional Chinese and Western medicine for PLC are mostly based on expert opinion. There is no evidence-based guideline for clinical practice in this field. Therefore, the Shanghai Association of Chinese Integrative Medicine has established a multidisciplinary working group to develop this guideline, which focuses on the most important questions about the use of TCM during PLC treatment. This guideline was developed following the methodological process recommended by the World Health Organization Handbook for Guideline Development. Two rounds of questionnaire survey were performed to identify clinical questions; published evidence was searched; the Grading of Recommendations Assessment, Development and Evaluation approach was used to evaluate the body of evidence; and recommendations were formulated by combining the quality of evidence, patient preferences and values, and other risk factors. The guideline was written based on the Reporting Items for Practice Guidelines in Healthcare tool. This guideline contains 10 recommendations related to 8 questions, including recommendations for early treatment by TCM after surgery, TCM combined with transcatheter arterial chemoembolization for advanced PLC, TCM drugs for external use, and acupuncture and moxibustion therapy. Copyright © 2018 Shanghai Changhai Hospital. Published by Elsevier B.V. All rights reserved.

[Research strategies in standard decoction of medicinal slices].

PubMed

Chen, Shi-Lin; Liu, An; Li, Qi; Toru, Sugita; Zhu, Guang-Wei; Sun, Yi; Dai, Yun-Tao; Zhang, Jun; Zhang, Tie-Jun; Takehisa, Tomoda; Liu, Chang-Xiao

2016-04-01

This paper discusses the research situation of the standard decoction of medicinal slices at home and abroad. Combined with the experimental data, the author proposes that the standard decoction of medicinal slices is made of single herb using standard process which should be guided by the theory of traditional Chinese medicine, based on clinical practice and referred to modern extraction method with a standard process. And the author also proposes the principles of establishing the specification of process parameters and quality standards and established the basis of drug efficacy material and biological reference. As a standard material and standard system, the standard decoction of medicinal slices can provide standards for clinical medication, standardize the use of the new type of medicinal slices especially for dispensing granules, which were widely used in clinical. It can ensure the accuracy of drugs and consistency of dose, and to solve current supervision difficulties. Moreover the study of standard decoction of medicinal slices will provide the research on dispensing granules, traditional Chinese medicine prescription standard decoction and couplet medicines standard decoction a useful reference. Copyright© by the Chinese Pharmaceutical Association.

Curriculum Redesign in Veterinary Medicine: Part II.

PubMed

Macik, Maria L; Chaney, Kristin P; Turner, Jacqueline S; Rogers, Kenita S; Scallan, Elizabeth M; Korich, Jodi A; Fowler, Debra; Keefe, Lisa M

Curricular review is considered a necessary component for growth and enhancement of academic programs and requires time, energy, creativity, and persistence from both faculty and administration. On a larger scale, a comprehensive redesign effort involves forming a dedicated faculty redesign team, developing program learning outcomes, mapping the existing curriculum, and reviewing the curriculum in light of collected stakeholder data. The faculty of the Texas A&M University College of Veterinary Medicine & Biomedical Sciences (TAMU) recently embarked on a comprehensive curriculum redesign effort through partnership with the university's Center for Teaching Excellence. Using a previously developed evidence-based model of program redesign, TAMU created a process for use in veterinary medical education, which is described in detail in the first part of this article series. An additional component of the redesign process that is understated, yet vital for success, is faculty buy-in and support. Without faculty engagement, implementation of data-driven curricular changes stemming from program evaluation may be challenging. This second part of the article series describes the methodology for encouraging faculty engagement through the final steps of the redesign initiative and the lessons learned by TAMU through the redesign process.

Making clinical case-based learning in veterinary medicine visible: analysis of collaborative concept-mapping processes and reflections.

PubMed

Khosa, Deep K; Volet, Simone E; Bolton, John R

2014-01-01

The value of collaborative concept mapping in assisting students to develop an understanding of complex concepts across a broad range of basic and applied science subjects is well documented. Less is known about students' learning processes that occur during the construction of a concept map, especially in the context of clinical cases in veterinary medicine. This study investigated the unfolding collaborative learning processes that took place in real-time concept mapping of a clinical case by veterinary medical students and explored students' and their teacher's reflections on the value of this activity. This study had two parts. The first part investigated the cognitive and metacognitive learning processes of two groups of students who displayed divergent learning outcomes in a concept mapping task. Meaningful group differences were found in their level of learning engagement in terms of the extent to which they spent time understanding and co-constructing knowledge along with completing the task at hand. The second part explored students' and their teacher's views on the value of concept mapping as a learning and teaching tool. The students' and their teacher's perceptions revealed congruent and contrasting notions about the usefulness of concept mapping. The relevance of concept mapping to clinical case-based learning in veterinary medicine is discussed, along with directions for future research.

Re-Imagining Program Development and Re-Engineering Program Design.

PubMed

Currie, Geoffrey M; Thomas, Catherine J

2018-05-03

Program development and review is a central part of institutional and industry quality assurance. Traditional approaches, while well established, present a number of barriers that could undermine process integrity and quality outcomes. Here a new approach to program development and design is explored with the goal of enhancing outcomes for students and institutions. Copyright © 2018 by the Society of Nuclear Medicine and Molecular Imaging, Inc.

National implementation of standards of practice for non-prescription medicines in Australia.

PubMed

Benrimoj, Shalom I; Gilbert, Andrew L; de Almeida Neto, Abilio C; Kelly, Fiona

2009-04-01

In Australia, there are two categories of non-prescription medicines: pharmacy medicines and pharmacist only medicines. Standards were developed to define and describe the professional activities required for the provision of these medicines at a consistent and measurable level of practice. Our objective was to implement nationally a quality improvement package in relation to the Standards of Practice for the Provision of Non-Prescription Medicines. Approximately 50% of Australian pharmacies (n = 2,706) were randomly selected by local registering authorities. Trained pharmacy educators audited each community pharmacy in the study three times, 7 weeks apart on Standards of Practice for the Provision of Non-Prescription Medicines, Visit 1 involved the educator explaining the project and conducting an assessment of the pharmacy's level of compliance. Behaviour of community pharmacists and their staff in relation to these standards was measured by conducting pseudo-patron visits. Pseudopatron visits were conducted at Visit 2, with the educator providing immediate feedback and coaching and a compliance assessment. Visit 3 involved a compliance assessment, and a second pseudo-patron visit for those pharmacies that had performed poorly at the first visit. At Visit 1, the lowest levels of compliance were to the standards relating to the documentation process (44%) and customer care and advice (46%). By Visit 2, more than 80% of pharmacies had met most criteria. At Visit 3, compliance had significantly improved compared to Visits 1 and 2 (P < 0.001). The lowest levels of compliance were to criteria which required written operating procedures for specific tasks, but these also improved significantly over time (P < 0.001). Professional practice in relation to the handling of pharmacist only and pharmacy medicines improved considerably as measured by the auditing process, and the results indicate that Australian pharmacies are well-equipped to provide high quality service to consumers of these medicines. The acceptability of national implementation of these standards of practice in Australia indicates that such an approach could be taken internationally.

Aqua mediated synthesis of bio-active compounds.

PubMed

Panda, Siva S

2013-05-01

Recently the aqueous medium has attracted the interest of organic chemists, and many. Moreover, in the past 20 years, the drug-discovery process has undergone extraordinary changes, and high-throughput biological screening of potential drug candidates has led to an ever-increasing demand for novel drug-like compounds. Noteworthy advantages were observed during the course of study on aqua mediated synthesis of compounds of medicinal importance. The established advantages of water as a solvent for reactions are, water is the most abundant and available resource on the planet and many biochemical processes occur in aqueous medium. This review will focus on describing new developments in the application of water in medicinal chemistry for the synthesis of bio-active compounds possessing various biological properties.

Overcoming regulatory and economic challenges facing pharmacogenomics.

PubMed

Cohen, Joshua P

2012-09-15

The number of personalized medicines and companion diagnostics in use in the United States has gradually increased over the past decade, from a handful of medicines and tests in 2001 to several dozen in 2011. However, the numbers have not reached the potential hoped for when the human genome project was completed in 2001. Significant clinical, regulatory, and economic barriers exist and persist. From a regulatory perspective, therapeutics and companion diagnostics are ideally developed simultaneously, with the clinical significance of the diagnostic established using data from the clinical development program of the corresponding therapeutic. Nevertheless, this is not (yet) happening. Most personalized medicines are personalized post hoc, that is, a companion diagnostic is developed separately and approved after the therapeutic. This is due in part to a separate and more complex regulatory process for diagnostics coupled with a lack of clear regulatory guidance. More importantly, payers have placed restrictions on reimbursement of personalized medicines and their companion diagnostics, given the lack of evidence on the clinical utility of many tests. To achieve increased clinical adoption of diagnostics and targeted therapies through more favorable reimbursement and incorporation in clinical practice guidelines, regulators will need to provide unambiguous guidance and manufacturers will need to bring more and better clinical evidence to the market place. Copyright © 2012 Elsevier B.V. All rights reserved.

A report on the Academic Emergency Medicine 2015 consensus conference "Diagnostic imaging in the emergency department: a research agenda to optimize utilization".

PubMed

Gunn, Martin L; Marin, Jennifer R; Mills, Angela M; Chong, Suzanne T; Froemming, Adam T; Johnson, Jamlik O; Kumaravel, Manickam; Sodickson, Aaron D

2016-08-01

In May 2015, the Academic Emergency Medicine consensus conference "Diagnostic imaging in the emergency department: a research agenda to optimize utilization" was held. The goal of the conference was to develop a high-priority research agenda regarding emergency diagnostic imaging on which to base future research. In addition to representatives from the Society of Academic Emergency Medicine, the multidisciplinary conference included members of several radiology organizations: American Society for Emergency Radiology, Radiological Society of North America, the American College of Radiology, and the American Association of Physicists in Medicine. The specific aims of the conference were to (1) understand the current state of evidence regarding emergency department (ED) diagnostic imaging utilization and identify key opportunities, limitations, and gaps in knowledge; (2) develop a consensus-driven research agenda emphasizing priorities and opportunities for research in ED diagnostic imaging; and (3) explore specific funding mechanisms available to facilitate research in ED diagnostic imaging. Through a multistep consensus process, participants developed targeted research questions for future research in six content areas within emergency diagnostic imaging: clinical decision rules; use of administrative data; patient-centered outcomes research; training, education, and competency; knowledge translation and barriers to imaging optimization; and comparative effectiveness research in alternatives to traditional computed tomography use.

Employment of the Triple Helix concept for development of regenerative medicine applications based on human pluripotent stem cells

PubMed Central

2014-01-01

Using human pluripotent stem cells as a source to generate differentiated progenies for regenerative medicine applications has attracted substantial interest during recent years. Having the capability to produce large quantities of human cells that can replace damaged tissue due to disease or injury opens novel avenues for relieving symptoms and also potentially offers cures for many severe human diseases. Although tremendous advancements have been made, there is still much research and development left before human pluripotent stem cell derived products can be made available for cell therapy applications. In order to speed up the development processes, we argue strongly in favor of cross-disciplinary collaborative efforts which have many advantages, especially in a relatively new field such as regenerative medicine based on human pluripotent stem cells. In this review, we aim to illustrate how some of the hurdles for bringing human pluripotent stem cell derivatives from bench-to-bed can be effectively addressed through the establishment of collaborative programs involving academic institutions, biotech industries, and pharmaceutical companies. By taking advantage of the strengths from each organization, innovation and productivity can be maximized from a resource perspective and thus, the chances of successfully bringing novel regenerative medicine treatment options to patients increase. PMID:24872863

Personalized Nanomedicine: A Revolution at the Nanoscale.

PubMed

Fornaguera, Cristina; García-Celma, Maria José

2017-10-12

Nanomedicine is an interdisciplinary research field that results from the application of nanotechnology to medicine and has the potential to significantly improve some current treatments. Specifically, in the field of personalized medicine, it is expected to have a great impact in the near future due to its multiple advantages, namely its versatility to adapt a drug to a cohort of patients. In the present review, the properties and requirements of pharmaceutical dosage forms at the nanoscale, so-called nanomedicines, are been highlighted. An overview of the main current nanomedicines in pre-clinical and clinical development is presented, detailing the challenges to the personalization of these therapies. Next, the process of development of novel nanomedicines is described, from their design in research labs to their arrival on the market, including considerations for the design of nanomedicines adapted to the requirements of the market to achieve safe, effective, and quality products. Finally, attention is given to the point of view of the pharmaceutical industry, including regulation issues applied to the specific case of personalized medicine. The authors expect this review to be a useful overview of the current state of the art of nanomedicine research and industrial production, and the future opportunities of personalized medicine in the upcoming years. The authors encourage the development and marketing of novel personalized nanomedicines.

Variety and evolution of American endoscopic image management and recording systems.

PubMed

Korman, L Y

1996-03-01

The rapid evolution of computing technology has and will continue to alter the practice of gastroenterology and gastrointestinal endoscopy. Development of communication standards for text, images, and security systems will be necessary for medicine to take advantage of high-speed computing and communications. Professional societies can have an important role in guiding the development process.

Pain medicine--a new credential in Canada.

PubMed

Morley-Forster, Patricia; Karpinski, Jolanta

2015-06-01

In 2010, Pain Medicine was formally recognized as a subspecialty in Canada by the Royal College of Physicians and Surgeons of Canada, a national organization with oversight of the medical education of specialists in Canada. The first trainees began their training at the Western University, London, Canada in July, 2014. This article traces the process of Pain Medicine's development as a discipline in Canada and outlines its multiple entry routes, 2-year curriculum, and assessment procedures. The application for specialty status was initiated in 2007 with the understanding that while Anesthesiology would be the parent specialty, the curriculum would train clinicians in a multidisciplinary setting. To receive recognition as a Royal College subspecialty, Pain Medicine had to successfully pass through three phases, each stage requiring formal approval by the Committee on Specialties. The multiple entry routes to this 2-year subspecialty program are described in this article as are the objectives of training, the curriculum, assessment of competency and the practice-eligibility route to certification. The process of accreditation of new training programs across Canada is also discussed. The new Pain Medicine training program in Canada will train experts in the prevention, diagnosis, treatment and rehabilitation of the spectrum of acute pain, cancer pain and non-cancer pain problems. These physicians will become leaders in education, research, advocacy and administration of this emerging field. Wiley Periodicals, Inc.

Biodesign process and culture to enable pediatric medical technology innovation.

PubMed

Wall, James; Wynne, Elizabeth; Krummel, Thomas

2015-06-01

Innovation is the process through which new scientific discoveries are developed and promoted from bench to bedside. In an effort to encourage young entrepreneurs in this area, Stanford Biodesign developed a medical device innovation training program focused on need-based innovation. The program focuses on teaching systematic evaluation of healthcare needs, invention, and concept development. This process can be applied to any field of medicine, including Pediatric Surgery. Similar training programs have gained traction throughout the United States and beyond. Equally important to process in the success of these programs is an institutional culture that supports transformative thinking. Key components of this culture include risk tolerance, patience, encouragement of creativity, management of conflict, and networking effects. Copyright © 2015 Elsevier Inc. All rights reserved.

Signal processing in ultrasound. [for diagnostic medicine

NASA Technical Reports Server (NTRS)

Le Croissette, D. H.; Gammell, P. M.

1978-01-01

Signal is the term used to denote the characteristic in the time or frequency domain of the probing energy of the system. Processing of this signal in diagnostic ultrasound occurs as the signal travels through the ultrasonic and electrical sections of the apparatus. The paper discusses current signal processing methods, postreception processing, display devices, real-time imaging, and quantitative measurements in noninvasive cardiology. The possibility of using deconvolution in a single transducer system is examined, and some future developments using digital techniques are outlined.

Selecting clinical quality indicators for laboratory medicine.

PubMed

Barth, Julian H

2012-05-01

Quality in laboratory medicine is often described as doing the right test at the right time for the right person. Laboratory processes currently operate under the oversight of an accreditation body which gives confidence that the process is good. However, there are aspects of quality that are not measured by these processes. These are largely focused on ensuring that the most clinically appropriate test is performed and interpreted correctly. Clinical quality indicators were selected through a two-phase process. Firstly, a series of focus groups of clinical scientists were held with the aim of developing a list of quality indicators. These were subsequently ranked in order by an expert panel of primary and secondary care physicians. The 10 top indicators included the communication of critical results, comprehensive education to all users and adequate quality assurance for point-of-care testing. Laboratories should ensure their tests are used to national standards, that they have clinical utility, are calibrated to national standards and have long-term stability for chronic disease management. Laboratories should have error logs and demonstrate evidence of measures introduced to reduce chances of similar future errors. Laboratories should make a formal scientific evaluation of analytical quality. This paper describes the process of selection of quality indicators for laboratory medicine that have been validated sequentially by deliverers and users of the service. They now need to be converted into measureable variables related to outcome and validated in practice.

Pharmacokinetic/Pharmacodynamic-Driven Drug Development

PubMed Central

Gallo, James M.

2010-01-01

The drug discovery and development enterprise, traditionally an industrial juggernaut, has spanned into the academic arena that is partially motivated by the National Institutes of Health Roadmap highlighting translational science and medicine. Since drug discovery and development represents a pipeline of basic to clinical investigations it meshes well with the prime “bench to the bedside” directive of translational medicine. The renewed interest in drug discovery and develpoment in academia provides an opportunity to rethink the hiearchary of studies with the hope to improve the staid approaches that have been critizied for lacking innovation. One area that has received limited attention concerns the use of pharmacokinetic [PK] and pharmacodynamic [PD] studies in the drug development process. Using anticancer drug development as a focus, this review will address past and current deficencies in how PK/PD studies are conducted and offer new strategies that might bridge the gap between preclinical and clinical trials. PMID:20687184

Recommended Amount of Sleep for a Healthy Adult: A Joint Consensus Statement of the American Academy of Sleep Medicine and Sleep Research Society

PubMed Central

Watson, Nathaniel F.; Badr, M. Safwan; Belenky, Gregory; Bliwise, Donald L.; Buxton, Orfeu M.; Buysse, Daniel; Dinges, David F.; Gangwisch, James; Grandner, Michael A.; Kushida, Clete; Malhotra, Raman K.; Martin, Jennifer L.; Patel, Sanjay R.; Quan, Stuart F.; Tasali, Esra

2015-01-01

Sleep is essential for optimal health. The American Academy of Sleep Medicine (AASM) and Sleep Research Society (SRS) developed a consensus recommendation for the amount of sleep needed to promote optimal health in adults, using a modified RAND Appropriateness Method process. The recommendation is summarized here. A manuscript detailing the conference proceedings and evidence supporting the final recommendation statement will be published in SLEEP and the Journal of Clinical Sleep Medicine. Citation: Watson NF, Badr MS, Belenky G, Bliwise DL, Buxton OM, Buysse D, Dinges DF, Gangwisch J, Grandner MA, Kushida C, Malhotra RK, Martin JL, Patel SR, Quan SF, Tasali E. Recommended amount of sleep for a healthy adult: a joint consensus statement of the American Academy of Sleep Medicine and Sleep Research Society. SLEEP 2015;38(6):843–844. PMID:26039963

Recommended Amount of Sleep for a Healthy Adult: A Joint Consensus Statement of the American Academy of Sleep Medicine and Sleep Research Society

PubMed Central

Watson, Nathaniel F.; Badr, M. Safwan; Belenky, Gregory; Bliwise, Donald L.; Buxton, Orfeu M.; Buysse, Daniel; Dinges, David F.; Gangwisch, James; Grandner, Michael A.; Kushida, Clete; Malhotra, Raman K.; Martin, Jennifer L.; Patel, Sanjay R.; Quan, Stuart F.; Tasali, Esra

2015-01-01

Sleep is essential for optimal health. The American Academy of Sleep Medicine (AASM) and Sleep Research Society (SRS) developed a consensus recommendation for the amount of sleep needed to promote optimal health in adults, using a modified RAND Appropriateness Method process. The recommendation is summarized here. A manuscript detailing the conference proceedings and evidence supporting the final recommendation statement will be published in SLEEP and the Journal of Clinical Sleep Medicine. Citation: Watson NF, Badr MS, Belenky G, Bliwise DL, Buxton OM, Buysse D, Dinges DF, Gangwisch J, Grandner MA, Kushida C, Malhotra RK, Martin JL, Patel SR, Quan SF, Tasali E. Recommended amount of sleep for a healthy adult: a joint consensus statement of the American Academy of Sleep Medicine and Sleep Research Society. J Clin Sleep Med 2015;11(6):591–592. PMID:25979105

Neurology or rehabilitation medicine?

PubMed Central

McLellan, D L

1992-01-01

Rehabilitation is a process of active change by which a person who is disabled acquires and uses the knowledge and skills necessary for optimal physical, psychological and social function. Rehabilitation medicine is now established in Britain as a specialty concerned primarily with three groups: 1) those with multiple disability; 2) disabled people undergoing personal or social transitions, for example, school leavers; and 3) those with disabilities requiring complex technical or medical solutions. Rehabilitation medicine is distinguished from traditional clinical neurology by its emphasis on teamwork and on the analysis and reduction of disability rather than the diagnosis and treatment of impairment. Both neurology and rehabilitation medicine are dwarfed by the size of the problems they are expected to overcome and there is no justification for competition between the two specialties. The training of neurologists requires fundamental changes if they are to be equipped to assist rehabilitation effectively and contribute to the scientific development of the subject. PMID:1532980

[The significance of drawing on experience of experimental study on Chinese materia medica during the Republican period].

PubMed

Li, Nan; Wan, Fang

2015-05-01

During the period of the Republic of China, researches of experiments on Chinese materia medica developed extensively with the scientific process of Chinese medicine. Although the technology standard was relatively low and the reference value, limited. The experiences, positive or negative, obtained at that time still has reference significance to today's Chinese medicine scientific research. The notion that traditional Chinese medical and scientific research be conducted under the guidance of TCM theory; valuable experience contained in the ancient literature of traditional Chinese medicine be collected; and the transformation capacity of scientific research be elevated, has been accepted by modern TCM professionals. If you go back to the history, it can be seen that this notion was summarized through repeated practice during the critical moment of traditional Chinese medicine, which should be emphasized and its understanding deepened at any time.

Genetic counselling in the era of genomic medicine

PubMed Central

Middleton, Anna

2018-01-01

Abstract Background Genomic technology can now deliver cost effective, targeted diagnosis and treatment for patients. Genetic counselling is a communication process empowering patients and families to make autonomous decisions and effectively use new genetic information. The skills of genetic counselling and expertise of genetic counsellors are integral to the effective implementation of genomic medicine. Sources of data Original papers, reviews, guidelines, policy papers and web-resources. Areas of agreement An international consensus on the definition of genetic counselling. Genetic counselling is necessary for implementation of genomic medicine. Areas of controversy Models of genetic counselling. Growing points Genomic medicine is a growing and strategic priority for many health care systems. Genetic counselling is part of this. Areas timely for developing research An evidence base is necessary, incorporating implementation and outcome research, to enable health care systems, practitioners, patients and families to maximize the utility (medically and psychologically) of the new genomic possibilities. PMID:29617718

Management of rheumatoid arthritis (Aamavata) using symbiohealth healthcare system

PubMed Central

Basisht, Gopal K.; Singh, Ram Harsh; Chandola, Harimohan

2012-01-01

Rheumatoid Arthritis (RA), according to modern medicine, and Aamavata according to Ayurveda, has an etiological and clinical relationship. Aamavata is a disease complex of which RA is a part. A comparative study of the pathophysiology of this disease by both systems reveals that modern medicine has investigated the mechanism of inflammation and has developed an offense strategy to control it. Ayurveda follows a defense strategy and it focuses its search on the etiological process, where disequilibrium at a higher level of physiology affects the gastrointestinal tract, causing an immune response that results in inflammation. Understanding the pathophysiology of both systems will help the treating physician to institute a dual treatment plan of modern medicine's offense strategy and Ayurvedic medicine's defense strategy at appropriate stages of the disease. Studying the pathophsiology of the two systems also gives insight into the genetic and epigenetic phenomenon in the treatment of disease and opens the doors for groundbreaking research. PMID:23723661

The First National Pain Medicine Summit--final summary report.

PubMed

Lippe, Philipp M; Brock, Charles; David, Jose; Crossno, Ronald; Gitlow, Stuart

2010-10-01

Pain is ubiquitous. At some point in time it affects everyone. For many millions pain becomes chronic, a scourge that impacts every facet of life-work, hobbies, family relations, social fabric, finances, happiness, mood, and even the very essence of identity. According to the National Institutes of Health (NIH), pain is one of our most important national public health problems, a silent epidemic. In 1998, NIH reported that the annual amount spent on health care, compensation, and litigation related to pain had reached one hundred billion dollars ($100,000,000,000). Considering that health care costs have doubled since then, it is not unreasonable to assume that the costs related to pain care have doubled as well. Millions of patients suffer needlessly with acute pain, with cancer pain, and with chronic pain. The ineffective management of pain results in an escalating cascade of health care issues. Acute pain that is not treated adequately and promptly results in persistent pain that eventually causes irreversible changes in the nervous system. This translates into progressive bio-psycho-social epiphenomena resulting in further pain and disability. It creates a vicious cycle transforming a functional human being into an invalid who becomes a burden to family, to society, and to oneself. In the face of adequate medical science, adequate technical skills, and adequate resources the reality of delayed and inadequate pain care is paradoxical. This dilemma deserves close scrutiny and effective remediation. The American Medical Association (AMA), long dedicated to the need to improve pain care in this country, has been faced with this reality. It was from this vision that the idea of holding a Pain Medicine Summit was conceived. Resolution 321 (A-08) set in motion a process that would bring together a diverse group of stakeholders for the purpose of discussing the present and future status of pain care; a process that culminated in a broad-based coalition of physicians and organizations dedicated to improving pain care, the first National Pain Medicine Summit. The process began with the adoption of Resolution 321 (A-08) at an AMA Annual House of Delegates meeting in June 2008. Resolution 321 (A-08) states, in part, that "...the AMA encourages relevant specialties to collaborate in studying: 1) the scope and practice and body of knowledge encompassed by the field of Pain Medicine; 2) the adequacy of undergraduate, graduate, and post graduate education in the principles and practices of the field of Pain Medicine, considering the current and anticipated medical need for the delivery of quality pain care; and 3) appropriate training and credentialing criteria for this multi-disciplinary field of medical practice." The next step was delegating the responsibility for implementing Resolution 321 (A-08) to the Pain and Palliative Medicine Specialty Section Council (PPMSSC). The PPMSSC, under the direction of its chairman, Philipp M. Lippe, MD, FACS, assumed responsibility in November 2008 for identifying a process that would achieve the goals established by Resolution 321 (A-08). The PPMSSC in turn established an Advisory Committee, charged with strategic planning, and an Implementation Committee, charged with tactical operations. The two groups began work immediately. The process included three distinct phases centered on a Pain Medicine Summit. Phase One involved a modified Delphi process identifying the five most pressing and relevant themes in pain care. Phase Two consisted of the Pain Medicine Summit itself, including a gathering of representatives from across the pain care spectrum to address the previously identified five most pressing themes. Phase Three was the preparation of this report, which describes the conclusions drawn and recommendations developed by the attendees at the Pain Medicine Summit. Based on a recommendation from the Advisory Committee, the PPMSSC decided to retain the services of a consulting firm to help the PPMSSC implement the Pain Medicine Summit process. In August 2009, PPMSSC selected Grey Matters, a New York-based advisory firm. The PPMSSC also appointed a Steering Committee to assist Grey Matters and to coordinate all activities. The Committee consisted of Charles Brock, MD; Ronald Crossno, MD; Jose David, MD; Michel Dubois, MD; Albert Ray, MD; and Philipp M. Lippe, MD, FACS (chair). The consulting firm, Grey Matters, proposed a multi-phasic process in order to facilitate the implementation of the Pain Medicine Summit and to ensure a coordinated, efficient, and productive outcome. This process consisting of three phases-pre-summit, summit, and post-summit-is described in detail in the following section. All aspects of the project were closely coordinated and supervised by the Steering Committee, which included the selection of the team leaders of the five Workgroups, based on specific criteria. The Pain Medicine Summit, adhering to the dictates of Resolution 321 (A-08), explored the body of knowledge and the scope of practice of Pain Medicine; the education and training in medical school, graduate, and postgraduate programs; and the credentialing and certification processes in the field of Pain Medicine. It addressed the barriers hampering delivery of high quality pain care. It recognized the need for clarification and consensus in many areas. Several points of consensus emerged: The continuum of medical education in the field of Pain Medicine is inadequate and fragmented. It needs to be fortified in scope, content, and duration. Credentialing and certification processes in Pain Medicine are variable, diverse, and deficient in many instances. Deficiencies in these areas lead to suboptimal and fragmented pain care having a negative impact on direct patient care and public health. Effective and prompt remediation is desirable and essential to achieving the goal of high quality pain care. Barriers exist inhibiting or retarding progress toward the common good. There are several viable avenues to achieving our stated goal, "excellence in the delivery of high quality, cost-effective pain care to the patients we serve," including the development of Pain Medicine as a distinct specialty with ACGME accredited residency programs and ABMS certification. The Pain Medicine Summit concluded with a number of recommendations, including the following: That the pain community remains engaged in addressing the issues raised and in mitigating the barriers. That the recommendations be referred to the AMA and the PPMSSC for support and implementation. That another national Pain Medicine Summit with enhanced participation be convened. That consideration be given to convening an International Pain Summit in conjunction with the IASP World Congress in Montreal.   That the final report of the Pain Medicine Summit be widely disseminated. Wiley Periodicals, Inc.

Analysing stratified medicine business models and value systems: innovation-regulation interactions.

PubMed

Mittra, James; Tait, Joyce

2012-09-15

Stratified medicine offers both opportunities and challenges to the conventional business models that drive pharmaceutical R&D. Given the increasingly unsustainable blockbuster model of drug development, due in part to maturing product pipelines, alongside increasing demands from regulators, healthcare providers and patients for higher standards of safety, efficacy and cost-effectiveness of new therapies, stratified medicine promises a range of benefits to pharmaceutical and diagnostic firms as well as healthcare providers and patients. However, the transition from 'blockbusters' to what might now be termed 'niche-busters' will require the adoption of new, innovative business models, the identification of different and perhaps novel types of value along the R&D pathway, and a smarter approach to regulation to facilitate innovation in this area. In this paper we apply the Innogen Centre's interdisciplinary ALSIS methodology, which we have developed for the analysis of life science innovation systems in contexts where the value creation process is lengthy, expensive and highly uncertain, to this emerging field of stratified medicine. In doing so, we consider the complex collaboration, timing, coordination and regulatory interactions that shape business models, value chains and value systems relevant to stratified medicine. More specifically, we explore in some depth two convergence models for co-development of a therapy and diagnostic before market authorisation, highlighting the regulatory requirements and policy initiatives within the broader value system environment that have a key role in determining the probable success and sustainability of these models. Copyright © 2012 Elsevier B.V. All rights reserved.

Increasing women's leadership in academic medicine: report of the AAMC Project Implementation Committee.

PubMed

Bickel, Janet; Wara, Diane; Atkinson, Barbara F; Cohen, Lawrence S; Dunn, Michael; Hostler, Sharon; Johnson, Timothy R B; Morahan, Page; Rubenstein, Arthur H; Sheldon, George F; Stokes, Emma

2002-10-01

The AAMC's Increasing Women's Leadership Project Implementation Committee examined four years of data on the advancement of women in academic medicine. With women comprising only 14% of tenured faculty and 12% of full professors, the committee concludes that the progress achieved is inadequate. Because academic medicine needs all the leaders it can develop to address accelerating institutional and societal needs, the waste of most women's potential is of growing importance. Only institutions able to recruit and retain women will be likely to maintain the best housestaff and faculty. The long-term success of academic health centers is thus inextricably linked to the development of women leaders. The committee therefore recommends that medical schools, teaching hospitals, and academic societies (1) emphasize faculty diversity in departmental reviews, evaluating department chairs on their development of women faculty; (2) target women's professional development needs within the context of helping all faculty maximize their faculty appointments, including helping men become more effective mentors of women; (3) assess which institutional practices tend to favor men's over women's professional development, such as defining "academic success" as largely an independent act and rewarding unrestricted availability to work (i.e., neglect of personal life); (4) enhance the effectiveness of search committees to attract women candidates, including assessment of group process and of how candidates' qualifications are defined and evaluated; and (5) financially support institutional Women in Medicine programs and the AAMC Women Liaison Officer and regularly monitor the representation of women at senior ranks.

[Cross-sectional field pain medicine Q14 - the Mainz model : Development of the pain medicine curriculum in the standard study course at the University Medical School of the Johannes Gutenberg University Mainz].

PubMed

Kurz, S; Buggenhagen, H; Schwab, R; Laufenberg-Feldmann, R

2017-10-01

Following the amendment of the Medical Licensure Act (ÄAppO) in 2012, pain medicine was introduced as a mandatory subject for students during undergraduate medical training. Medical schools were required to define and to implement adequate curricular and formal teaching structures based on interdisciplinary and multiprofessional requirements according to the curriculum for pain medicine of the German Pain Society. These aspects were considered in the new interdisciplinary curriculum for pain medicine, the so-called Mainz model. A new curriculum based on the Kern cycle was developed and implemented at the Medical Center of the Johannes Gutenberg University in Mainz. Different teaching methods (lectures, interprofessional tutorials and bedside coaching in small groups) were used to impart professional expertise in pain medicine to medical students in an interdisciplinary clinical context. The new curriculum was put into practice and evaluated starting from the winter semester 2014/2015. Before and after the first implementation, medical students were asked about the relevance of pain medicine and their perception of personal competence. The interdisciplinary course in pain medicine was successfully introduced into the degree program based on the curriculum of the German Pain Society and the Kern cycle. With educational support, interdepartmental and multiprofessional collaboration the process of implementation of new interdisciplinary courses can be facilitated. In the future, the question how to increase the amount of practical lessons without increasing the load on teaching resources has to be resolved. Blended learning modules, such as a combination of E‑learning and practical lessons are currently being studied in smaller cohorts.

[Construction of biopharmaceutics classification system of Chinese materia medica].

PubMed

Liu, Yang; Wei, Li; Dong, Ling; Zhu, Mei-Ling; Tang, Ming-Min; Zhang, Lei

2014-12-01

Based on the characteristics of multicomponent of traditional Chinese medicine and drawing lessons from the concepts, methods and techniques of biopharmaceutics classification system (BCS) in chemical field, this study comes up with the science framework of biopharmaceutics classification system of Chinese materia medica (CMMBCS). Using the different comparison method of multicomponent level and the CMMBCS method of overall traditional Chinese medicine, the study constructs the method process while setting forth academic thoughts and analyzing theory. The basic role of this system is clear to reveal the interaction and the related absorption mechanism of multicomponent in traditional Chinese medicine. It also provides new ideas and methods for improving the quality of Chinese materia medica and the development of new drug research.

A Method of Classifying Tongue Colors for Traditional Chinese Medicine Diagnosis Based on the CIELAB Color Space

NASA Astrophysics Data System (ADS)

Li, Bocong; Huang, Qingmei; Lu, Yan; Chen, Songhe; Liang, Rong; Wang, Zhaoping

Objective tongue color analysis is an important research point for tongue diagnosis in Traditional Chinese Medicine. In this paper a research based on the clinical process of diagnosing tongue color is reported. The color data in RGB color space were first transformed into the data in CIELAB color space, and the color gamut of the displayed tongue was obtained. Then a numerical method of tongue color classification based on the Traditional Chinese Medicine (for example: light white tongue, light red tongue, red tongue) was developed. The conclusion is that this research can give the description and classification of the tongue color close to those given by human vision and may be carried out in clinical diagnosis.

[Challenge prevention. From curative to preventive medicine-strategic and operational challenges].

PubMed

Schönermark, M P; Greif, K

2008-04-01

The potentials of preventive medicine to reduce the costs of illness have been inadequately exploited to date. Even if there is still massive dissent regarding the legal setup of a prevention law, prevention should play a significantly higher role in practice. Clinicians and practitioners could use preventive medicine as another differentiating factor in the increasingly competitive healthcare field. Prevention as a new strategic business segment allows a directed reaction to the demands of the payment system and opens up enormous value-added potential at the same time. Those who seize the chance to integrate prevention into their medical services portfolio and into the structure and processes of their respective hospitals will develop an important competitive advantage for the future.

Personalized plasma-based medicine to treat age-related diseases.

PubMed

Anitua, Eduardo; Troya, María; Zalduendo, Mar; Orive, Gorka

2017-05-01

As social and health needs are changing, new challenges to develop innovative alternatives arise to address unmet medical needs. Personalized medicine is emerging as a promising and appealing therapeutic option. The use of patient's own plasma and platelets as therapeutics is providing new avenues in the treatment of acute and chronic tissue injuries by promoting tissue repair and regeneration. Plasma and platelet-based therapies mimic the physiological repair process by releasing autologous growth factors and creating a natural, biodegradable and transient scaffold that acts as transient matrix. This review summarizes the recent advances and challenges in the field of personalized plasma-based medicine and its potential to treat age-related diseases. Copyright © 2016. Published by Elsevier B.V.

42 CFR 425.112 - Required processes and patient-centeredness criteria.

Code of Federal Regulations, 2013 CFR

2013-10-01

.... (a) General. (1) An ACO must— (i) Promote evidence-based medicine and beneficiary engagement... to accomplish the following: (1) Promote evidence-based medicine. These processes must cover...) Communication of clinical knowledge/evidence-based medicine to beneficiaries in a way that is understandable to...

42 CFR 425.112 - Required processes and patient-centeredness criteria.

Code of Federal Regulations, 2014 CFR

2014-10-01

.... (a) General. (1) An ACO must— (i) Promote evidence-based medicine and beneficiary engagement... to accomplish the following: (1) Promote evidence-based medicine. These processes must cover...) Communication of clinical knowledge/evidence-based medicine to beneficiaries in a way that is understandable to...

42 CFR 425.112 - Required processes and patient-centeredness criteria.

Code of Federal Regulations, 2012 CFR

2012-10-01

.... (a) General. (1) An ACO must— (i) Promote evidence-based medicine and beneficiary engagement... to accomplish the following: (1) Promote evidence-based medicine. These processes must cover...) Communication of clinical knowledge/evidence-based medicine to beneficiaries in a way that is understandable to...

Hormesis and medicine

PubMed Central

Calabrese, Edward J

2008-01-01

Evidence is presented which supports the conclusion that the hormetic dose–response model is the most common and fundamental in the biological and biomedical sciences, being highly generalizable across biological model, endpoint measured and chemical class and physical agent. The paper provides a broad spectrum of applications of the hormesis concept for clinical medicine including anxiety, seizure, memory, stroke, cancer chemotherapy, dermatological processes such as hair growth, osteoporosis, ocular diseases, including retinal detachment, statin effects on cardiovascular function and tumour development, benign prostate enlargement, male sexual behaviours/dysfunctions, and prion diseases. PMID:18662293

The continuum of personalized cardiovascular medicine: a position paper of the European Society of Cardiology.

PubMed

Kirchhof, Paulus; Sipido, Karin R; Cowie, Martin R; Eschenhagen, Thomas; Fox, Keith A A; Katus, Hugo; Schroeder, Stefan; Schunkert, Heribert; Priori, Silvia

2014-12-07

There is strong need to develop the current stratified practice of CVD management into a better personalized cardiovascular medicine, within a broad framework of global patient care. Clinical information obtained from history and physical examination, functional and imaging studies, biochemical biomarkers, genetic/epigenetic data, and pathophysiological insights into disease-driving processes need to be integrated into a new taxonomy of CVDs to allow personalized disease management. This has the potential for major health benefits for the population suffering from cardiovascular diseases.

Profiling and analysis of multiple constituents in Baizhu Shaoyao San before and after processing by stir-frying using UHPLC/Q-TOF-MS/MS coupled with multivariate statistical analysis.

PubMed

Xu, Yangyang; Cai, Hao; Cao, Gang; Duan, Yu; Pei, Ke; Tu, Sicong; Zhou, Jia; Xie, Li; Sun, Dongdong; Zhao, Jiayu; Liu, Jing; Wang, Xiaoqi; Shen, Lin

2018-04-15

Baizhu Shaoyao San (BSS) is a famous traditional Chinese medicinal formula widely used for the treatment of painful diarrhea, intestinal inflammation, and diarrhea-predominant irritable bowel syndrome. According to clinical medication, three medicinal herbs (Atractylodis Macrocephalae Rhizoma, Paeoniae Radix Alba, and Citri Reticulatae Pericarpium) included in BSS must be processed using some specific methods of stir-frying. On the basis of the classical theories of traditional Chinese medicine, the therapeutic effects of BSS would be significantly enhanced after processing. Generally, the changes of curative effects mainly result from the variations of inside chemical basis caused by the processing procedure. To find out the corresponding changes of chemical compositions in BSS after processing and to elucidate the material basis of the changed curative effects, an optimized ultra-high-performance liquid chromatography-quadrupole/time-of-flight mass spectrometry in positive and negative ion modes coupled with multivariate statistical analyses were developed. As a result, a total of 186 compounds were ultimately identified in crude and processed BSS, in which 62 marker compounds with significant differences between crude and processed BSS were found by principal component analysis and t-test. Compared with crude BSS, the contents of 23 compounds were remarkably decreased and the contents of 39 compounds showed notable increase in processed BSS. The transformation mechanisms of some changed compounds were appropriately inferred from the results. Furthermore, compounds with extremely significant differences might strengthen the effects of the whole herbal formula. Copyright © 2018 Elsevier B.V. All rights reserved.

From art to science: a new epistemological status for medicine? On expectations regarding personalized medicine.

PubMed

Wiesing, Urban

2017-12-20

Personalized medicine plays an important role in the development of current medicine. Among the numerous statements regarding the future of personalized medicine, some can be found that accord medicine a new scientific status. Medicine will be transformed from an art to a science due to personalized medicine. This prognosis is supported by references to models of historical developments. The article examines what is meant by this prognosis, what consequences it entails, and how feasible it is. It refers to the long tradition of epistemological thinking in medicine and the use of historical models for the development of medicine. The possible answers to the question "art or science" are systematized with respect to the core question about the relationship between knowledge and action. The prediction for medicine to develop from an 'empirical healing art' to a 'rational, molecular science' is nonsensical from an epistemological point of view. The historical models employed to substantiate the development of personalized medicine are questionable.

[Current status of the development of wireless sensors for medical applications].

PubMed

Moor, C; Braecklein, M; Jörns, N

2005-01-01

Wireless near-field transmission has been a challenge for scientists developing medical sensors for a long time. Here, instruments which measure a patient's ECG, oxygen saturation, blood pressure, peak flow, weight, blood glucose etc. are to be equipped with suitable transmission technology. Application scenarios for these sensors can be found in all medical areas where cable connections are irritating for the doctor, patient and other care personnel. This problem is especially common in sport medicine, sleep medicine, emergency medicine and intensive care. Based on its beneficial properties with regard to power consumption, range, data security and network capability, the worldwide standard radio technology Bluetooth was selected to transmit measurements. Since digital data is sent to a receiving station via Bluetooth, the measurement pre-processing now takes place in the patient sensor itself, instead of being processed by the monitor. In this article, a Bluetooth ECG, Bluetooth pulse oximeter, Bluetooth peak flow meter and Bluetooth event recorder will be introduced. On the one hand, systems can be realized with these devices, which allow patients to be monitored online (ECG, pulse oximeter). These devices can also be integrated in disease management programs (peak flow meter) and can be used to monitor high-risk patients in their home environment (event recorder).

[New idea of traditional Chinese medicine quality control based on "composition structure" theory].

PubMed

Liu, Dan; Jia, Xiaobin; Yu, Danhong

2012-03-01

On the road of the modern Chinese medicine developing internationally, there is a key issues that setting up a reasonable, accurate and be quantified quality evaluation system which is comply with the basic theory of Chinese medicine. Based on the overall understanding of the role of traditional Chinese medicine components, author suggested that the idea of "structural components" theory should be embedded into the system and thought the Chinese medicine play a multi-target, multi-channel pharmacodynamic effects founded on the specific microcosmic structural relationship between the components and the components within the group. At present, the way of Chinese pharmacopoeia checking the quality of Chinese medicine is mainly depends on controlling the single or multiple targets of ingredients. In fact, this way is out of the overall effectiveness of the Chinese medicine, so we can not thoroughly controlling the quality of Chinese medicine from the essence of the Chinese medicine. Secondly, it's only macro-structural quantity that the Chinese pharmacopoeia just controlling the less effective ingredients, this is not enough to reflect the internal microstructure of the integrity and systematic. In other words, this cannot reflect the structural components of the Chinese medicine (the essence of traditional Chinese medicine). In view of above mentioned reasons, the author propose the new idea on the quality control in the medicine that quantify the ratio structural relationship in component and the ingredients of the components, set the optimal controlling proportion between the components and ingredients. At the same time, author thought we should conduct the depth study in the micro-quantified the multi-component and multi-ingredient, in the process of studying the material basis of Chinese medicine. Therefore, it could establish a more rational basis for the Chinese medicine quality controlling system.

Establishment of research-oriented hospital: an important way for translational medicine development in China.

PubMed

Li, Meina; Zhang, Lulu

2015-01-01

Globally, one of the major trends is the development of translational medicine. The traditional hospital structure could not meet the demands of translational medicine development any longer and to explore a novel hospital structure is imperative. Following the times, China proposed and implemented a development strategy for a first-class modern research-oriented hospital. To establish a research-oriented hospital has become an important strategy to guide the scientific development of high-quality medical institutions and to advance translational medicine development. To facilitate translational medicine by developing research-oriented hospital, the Chinese Research Hospital Association (CRHA) has been established, which provides service of medicine, talents cultivation, scientific research and clinical teaching and covers areas of theoretical research, academic exchange, translational medicine, talents training and practice guiding. On the whole, research-oriented hospital facilitated translational medicine by developing interdisciplinary platform, training core competencies in clinical and translational research, providing financial support of translational research, and hosting journals on translational medicine, etc.

Measuring performance to drive improvement: development of a clinical indicator set for general medicine.

PubMed

Brand, C; Lam, S K L; Roberts, C; Gorelik, A; Amatya, B; Smallwood, D; Russell, D

2009-06-01

There are delays in implementing evidence about effective therapy into clinical practice. Clinical indicators may support implementation of guideline recommendations. To develop and evaluate the short-term impact of a clinical indicator set for general medicine. A set of clinical process indicators was developed using a structured process. The indicator set was implemented between January 2006 and December 2006, using strategies based on evidence about effectiveness and local contextual factors. Evaluation included a structured survey of general medical staff to assess awareness and attitudes towards the programme and qualitative assessment of barriers to implementation. Impact on documentation of adherence to clinical indicators was assessed by auditing a random sample of medical records before (2003-2005) and after (2006) implementation. Clinical indicators were developed for the following areas: venous thromboembolism, cognition, chronic heart failure, chronic obstructive pulmonary disease, diabetes, low trauma fracture, patient written care plans. The programme was well supported and incurred little burden to staff. Implementation occurred largely as planned; however, documentation of adherence to clinical indicators was variable. There was a generally positive trend over time, but for most indicators this was independent of the implementation process and may have been influenced by other system improvement activities. Failure to demonstrate a significant impact during the pilot phase is likely to have been influenced by administrative factors, especially lack of an integrative data documentation and collection process. Successful implementation in phase two is likely to depend upon an effective data collection system integrated into usual care.

Historical Lessons in Translational Medicine: Cyclooxygenase Inhibition and P2Y12 Antagonism

PubMed Central

Fitzgerald, Desmond J.; FitzGerald, Garret A.

2013-01-01

The development of drugs that inhibit platelets has been driven by a combination of clinical insights, fundamental science and sheer luck. The process has evolved as the days of stumbling upon therapeutic gems like aspirin have long passed and have been replaced by an arduous process where a drug is designed to target a specific protein implicated in a well-characterized pathophysiological process. Or so we would like to believe. The development of antiplatelet therapy illustrates the importance of understanding the mechanisms of disease and the pharmacology of the compounds we develop, coupled with careful clinical experimentation and observation. And yes, still, a fair bit of luck. PMID:23287454

Client-side Medical Image Colorization in a Collaborative Environment.

PubMed

Virag, Ioan; Stoicu-Tivadar, Lăcrămioara; Crişan-Vida, Mihaela

2015-01-01

The paper presents an application related to collaborative medicine using a browser based medical visualization system with focus on the medical image colorization process and the underlying open source web development technologies involved. Browser based systems allow physicians to share medical data with their remotely located counterparts or medical students, assisting them during patient diagnosis, treatment monitoring, surgery planning or for educational purposes. This approach brings forth the advantage of ubiquity. The system can be accessed from a any device, in order to process the images, assuring the independence towards having a specific proprietary operating system. The current work starts with processing of DICOM (Digital Imaging and Communications in Medicine) files and ends with the rendering of the resulting bitmap images on a HTML5 (fifth revision of the HyperText Markup Language) canvas element. The application improves the image visualization emphasizing different tissue densities.

A double-sided microscope to realize whole-ganglion imaging of membrane potential in the medicinal leech

PubMed Central

Wagenaar, Daniel A

2017-01-01

Studies of neuronal network emergence during sensory processing and motor control are greatly facilitated by technologies that allow us to simultaneously record the membrane potential dynamics of a large population of neurons in single cell resolution. To achieve whole-brain recording with the ability to detect both small synaptic potentials and action potentials, we developed a voltage-sensitive dye (VSD) imaging technique based on a double-sided microscope that can image two sides of a nervous system simultaneously. We applied this system to the segmental ganglia of the medicinal leech. Double-sided VSD imaging enabled simultaneous recording of membrane potential events from almost all of the identifiable neurons. Using data obtained from double-sided VSD imaging, we analyzed neuronal dynamics in both sensory processing and generation of behavior and constructed functional maps for identification of neurons contributing to these processes. PMID:28944754

Comparative Study on the Education System of Traditional Medicine in China, Japan, Korea, and Taiwan.

PubMed

Park, Yu Lee; Huang, Ching Wen; Sasaki, Yui; Ko, Youme; Park, Sunju; Ko, Seong-Gyu

2016-01-01

China, Japan, Korea, and Taiwan have developed modernized education systems in traditional medicine. This study aims to provide an overview of the education systems in these countries and compare them. Data were collected through the websites of government agencies, universities, and relevant organizations. These countries have systemically developed basic medical education (BME), postgraduate medical education (PGME), and continuing medical education (CME) in traditional medicine. BME is provided at colleges of traditional medicine at the undergraduate level and graduate levels. The length of education at the undergraduate level is five, six, and seven years in China, Korea, and Taiwan, respectively; the length at the graduate level is four years in Korea and five years in Taiwan. A seven- or eight-year program combining undergraduate and graduate courses is unique to China. In Japan, unlike in other countries, there are two distinct education systems-one is comprised of courses on traditional medicine included in the curriculum for Western medical doctors, and the other is a three- or four-year undergraduate program for practitioners including acupuncturists and moxibustionists. PGME in Korea consists of one-year internship and three-year residency programs which are optional; however, in China and Taiwan, internship is required for the national licensing examination and further training is in the process of standardization. The required credits for maintenance of CME are eight per year in Korea, 25 per year in China, and 180 over six years in Taiwan. The design of the educational systems in these countries can provide useful information for the development of education in traditional medicine around the world. Copyright © 2016. Published by Elsevier Inc.

Research in progress: FY 1992. Summaries of projects

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

Not Available

1993-08-01

The Biological and Environmental Research (BER) Program of OHER has two main missions: (1) to develop the knowledge base necessary to identify, understand, and anticipate the long-term health and environmental consequences of energy use and development and (2) to utilize the Department`s unique scientific and technological capabilities to solve major scientific problems in medicine, biology, and the environment. These missions reflect a commitment to develop the beneficial uses of advanced energy technologies while at the same time assuring that any potentially adverse health and environmental impacts of the Nation`s energy policies are fully identified and understood. The BER Program includesmore » research in atmospheric, marine, and terrestrial processes, including the linkage between the use in greenhouse gases, carbon dioxide, and regional and global climate change; in molecular and subcellular mechanisms underlying human somatic and genetic processes and their responses to energy-related environmental toxicants; in nuclear medicine, structural biology, the human genome, measurement sciences and instrumentation, and other areas that require the unique capabilities of the Department`s laboratory system. The principal areas of research are Health Research and Environmental Research.« less

Development of anti-inflammatory drugs - the research and development process.

PubMed

Knowles, Richard Graham

2014-01-01

The research and development process for novel drugs to treat inflammatory diseases is described, and several current issues and debates relevant to this are raised: the decline in productivity, attrition, challenges and trends in developing anti-inflammatory drugs, the poor clinical predictivity of experimental models of inflammatory diseases, heterogeneity within inflammatory diseases, 'improving on the Beatles' in treating inflammation, and the relationships between big pharma and biotechs. The pharmaceutical research and development community is responding to these challenges in multiple ways which it is hoped will lead to the discovery and development of a new generation of anti-inflammatory medicines. © 2013 Nordic Pharmacological Society. Published by John Wiley & Sons Ltd.

[Holistic integrative medicine: the road to the future of the development of burn medicine].

PubMed

Fan, D M

2017-01-20

Holistic integrative medicine is the road to the future of the development of burn medicine. Not only burn medicine, but also human medicine gradually enters the era of holistic integrative medicine. Holistic integrative medicine is different from translational medicine, evidence-based medicine or precision medicine, which integrates the most advanced knowledge and theories in medicine fields with the most effective practices and experiences in clinical specialties to form a new medical system.

Rational use of medicines - Indian perspective!

PubMed

Mohanta, G P; Manna, P K

2015-01-01

India, the largest democracy in the world, is with a federal structure of 29 states and 7 union territories. With a population of more than 1.2 billion, resource is always a constraint and so is in the health system too. In the federal structure, providing healthcare is largely the responsibility of state governments. Medicines are important component of health care delivery system and quality care is dependent on the availability and proper use of quality medicines. In spite of being known as pharmacy of the third world, poor access to medicines in the country is always a serious concern. Realizing the need of quality use of medicines, several initiatives have been initiated. As early as 1994, seeds of rational use of medicines were sown in the country with two initiatives: establishment of a civil society, Delhi Society for Promoting Rational Use of Drugs (DSPURD) and establishment of government agency in Tamil Nadu, a southern state, called Tamil Medical Services Corporation Limited (TNMSCL). DSPUD was in official association with World Health Organization Country Office for implementing essential medicine programme in the country for two biennia. In addition to organizing sensitising and training programme for healthcare professionals throughout the country, it looked after the procurement and appropriate use of medicines in Delhi government health facilities. TNMSCL has made innovations in medicine management including procurement directly from manufacturers as a part of pooled procurement, establishing warehouses with modern storage facilities and Information Technology enabled management of whole process. TNMSCL Model is now replicated in almost the entire country and even in some small other countries as it is successful in improving access to medicines.The National Government and the State Governments have developed strategies to promote rational use of medicines as a part of improving access and quality care in public health facilities. National Government developed policies and regulations for combating antimicrobial resistance, controlling the prices of medicines, establishing generic medicines stores and advocating for the need for improvement of medicine logistics at state level and prescription auditing system. There is wide variation in medicine procurement and management system among the states. Spending on medicines ranges from as small as 2% of health budget to as high as 17%. The procurement system varies from individual facilities to partial pooled procurement to complete centralised system.There are attempts of developing essential medicine lists, standard treatment guidelines and costing of treatment of common illnesses. Except for the few states, essential medicine list remains an ornamental showpiece. However, with apex court's intervention, the prices are now controlled for all 348 medicines listed in national list. The pharmaceutical companies continue to violate price regulations either through making the medicines at different strengths or new fixed dose combinations (FDCs). Perhaps the largest number of FDCs and many of them with no valid justification are available in the country. Decisions on compulsory licensing have made the new anticancer medicines affordable. Other countries have also benefited from this decision. While some progress has been made for appropriate use of medicines in public health facilities, there are little efforts in private sectors and at community levels. Availability of prescription medicines without much control and free drug advertising are other concerns. Like all other countries irrational use of medicines continues to be of concern in India despite of several attempts of improving use of medicines both in the health system as well as in community. But efforts continue to be made for improving the use of medicines!

Integrating evolutionary game theory into epigenetic study of embryonic development. Comment on ;Epigenetic game theory: How to compute the epigenetic control of maternal-to-zygotic transition; by Qian Wang et al.

NASA Astrophysics Data System (ADS)

Wang, Zuoheng

2017-03-01

DNA methylation is an essential component in the epigenetic regulation of embryonic development, and plays a crucial role in various biological processes, including repression of gene transcription, parent-of-origin genomic imprinting, and X-chromosome inactivation [1-5]. Understanding the epigenetic processes in different stages of embryo development has become an important research topic in the field. It has potential to offer new insight into reproductive medicine and contribute to the improvement of long-term health outcomes.

The Development of Best Practice Recommendations to Support the Hiring, Recruitment, and Advancement of Women Physicians in Emergency Medicine.

PubMed

Choo, Esther K; Kass, Dara; Westergaard, Mary; Watts, Susan H; Berwald, Nicole; Regan, Linda; Promes, Susan B; Clem, Kathleen J; Schneider, Sandra M; Kuhn, Gloria J; Abbuhl, Stephanie; Nobay, Flavia

2016-11-01

Women in medicine continue to experience disparities in earnings, promotion, and leadership roles. There are few guidelines in place defining organization-level factors that promote a supportive workplace environment beneficial to women in emergency medicine (EM). We assembled a working group with the goal of developing specific and feasible recommendations to support women's professional development in both community and academic EM settings. We formed a working group from the leadership of two EM women's organizations, the Academy of Women in Academic Emergency Medicine (AWAEM) and the American Association of Women Emergency Physicians (AAWEP). Through a literature search and discussion, working group members identified four domains where organizational policies and practices supportive of women were needed: 1) global approaches to supporting the recruitment, retention, and advancement of women in EM; 2) recruitment, hiring, and compensation of women emergency physicians; 3) supporting development and advancement of women in EM; and 4) physician health and wellness (in the context of pregnancy, childbirth, and maternity leave). Within each of these domains, the working group created an initial set of specific recommendations. The working group then recruited a stakeholder group of EM physician leaders across the country, selecting for diversity in practice setting, geographic location, age, race, and gender. Stakeholders were asked to score and provide feedback on each of the recommendations. Specific recommendations were retained by the working group if they achieved high rates of approval from the stakeholder group for importance and perceived feasibility. Those with >80% agreement on importance and >50% agreement on feasibility were retained. Finally, recommendations were posted in an open online forum (blog) and invited public commentary. An initial set of 29 potential recommendations was created by the working group. After stakeholder voting and feedback, 16 final recommendations were retained. Recommendations were refined through qualitative comments from stakeholders and blog respondents. Using a consensus building process that included male and female stakeholders from both academic and community EM settings, we developed recommendations for organizations to implement to create a workplace environment supportive of women in EM that were perceived as acceptable and feasible. This process may serve as a model for other medical specialties to establish clear, discrete organization-level practices aimed at supporting women physicians. © 2016 by the Society for Academic Emergency Medicine.

Quality Issues Identified During the Evaluation of Biosimilars by the European Medicines Agency's Committee for Medicinal Products for Human Use.

PubMed

Cilia, Mark; Ruiz, Sol; Richardson, Peter; Salmonson, Tomas; Serracino-Inglott, Anthony; Wirth, Francesca; Borg, John Joseph

2018-02-01

The aim of this study was to identify trends in deficiencies raised during the EU evaluation of the quality part of dossiers for marketing authorisation applications of biosimilar medicinal products. All adopted day 120 list of questions on the quality module of 22 marketing authorisation applications for biosimilars submitted to the European Medicines Agency and concluded by the end of October 2015 was analysed. Frequencies of common deficiencies identified were calculated and summarised descriptions included. Frequencies and trends on quality deficiencies were recorded and presented for 22 biosimilar applications. Thirty-two 'major objections' for 9 products were identified from 14 marketing authorisation applications with 15 raised for drug substance and 17 for drug product. In addition, 547 'other concerns' for drug substance and 495 for drug product were also adopted. The frequencies and trends of the identified deficiencies together with their impact were discussed from a regulatory perspective and how these impact key manufacturing processes and key materials used in the production of biosimilars. This study provides an insight to the regulatory challenges prospective companies need to consider when developing biosimilars; it also helps elucidate common pitfalls in the development and production of biosimilars and in the submission of dossiers for their marketing authorisations. The results are expected to be of interest to pharmaceutical companies but also to regulators to obtain consistent information on medicinal products based on transparent rules safeguarding the necessary pharmaceutical quality of medicinal products.

Nationwide program of education for undergraduates in the field of disaster medicine: development of a core curriculum centered on blended learning and simulation tools.

PubMed

Ingrassia, Pier Luigi; Ragazzoni, Luca; Tengattini, Marco; Carenzo, Luca; Della Corte, Francesco

2014-10-01

In recent years, effective models of disaster medicine curricula for medical schools have been established. However, only a small percentage of medical schools worldwide have considered at least basic disaster medicine teaching in their study program. In Italy, disaster medicine has not yet been included in the medical school curriculum. Perceiving the lack of a specific course on disaster medicine, the Segretariato Italiano Studenti in Medicina (SISM) contacted the Centro di Ricerca Interdipartimentale in Medicina di Emergenza e dei Disastri ed Informatica applicata alla didattica e alla pratica Medica (CRIMEDIM) with a proposal for a nationwide program in this field. Seven modules (introduction to disaster medicine, prehospital disaster management, definition of triage, characteristics of hospital disaster plans, treatment of the health consequences of different disasters, psychosocial care, and presentation of past disasters) were developed using an e-learning platform and a 12-hour classroom session which involved problem-based learning (PBL) activities, table-top exercises, and a computerized simulation (Table 1). The modules were designed as a framework for a disaster medicine curriculum for undergraduates and covered the three main disciplines (clinical and psychosocial, public health, and emergency and risk management) of the core of "Disaster Health" according to the World Association for Disaster and Emergency Medicine (WADEM) international guidelines for disaster medicine education. From January 2011 through May 2013, 21 editions of the course were delivered to 21 different medical schools, and 524 students attended the course. The blended approach and the use of simulation tools were appreciated by all participants and successfully increased participants' knowledge of disaster medicine and basic competencies in performing mass-casualty triage. This manuscript reports on the designing process and the initial outcomes with respect to learners' achievements and satisfaction of a 1-month educational course on the fundamentals of disaster medicine. This experience might represent a valid and innovative solution for a disaster medicine curriculum for medical students that is easily delivered by medical schools. [table: see text].

Public-private partnerships as driving forces in the quest for innovative medicines

PubMed Central

2013-01-01

Background Despite progress in translational research, we are still falling short in developing the innovative medicines required to address major public health needs. Furthermore, the failure rate, time, and cost required for registration of a new drug are pushing the economics of the industry to the breaking point. New models of drug development based on collaborative endeavours are badly needed to improve this dire situation. Findings In 2004, the US Food and Drug Administration (FDA) introduced the Critical Path Initiative with the intent of modernizing drug development by implementing public-private partnerships (PPP) to share data, expertise, and resources. In response to FDA’s initiative, in the following year the non-profit Critical Path Institute (C-Path) was formed. At the same time, the National Institutes of Health (NIH) Public-Private Partnership program was established. In Europe, the Innovative Medicines Initiative (IMI) supported jointly by the European Union and the European Federation of Pharmaceutical Industries and Associations was launched in 2008. These independent efforts have a common long-term objective, namely to facilitate the emergence of innovative medicines by developing new tools for drug discovery, new indicators for drug efficacy or safety, and new approaches for patient stratification. Herein, we present evidence that PPP already exert a positive impact on the drug development process. Conclusions Public-private partnerships represent attractive means to leverage resources dispersed across industry, academia, and voluntary health organizations in order to address multiple challenges of drug development in an era of constrained resources and increased regulatory pressure. PMID:23369569

[A study of development of medicine and science in the nineteenth century science fiction: biomedical experiments in Mary Shelley's Frankenstein].

PubMed

Choo, Jae-Uk

2014-12-01

As the sciences advanced rapidly in the modern European world, outstanding achievements have been made in medicine, chemistry, biology, physiology, physics and others, which have been co-influencing each of the scientific disciplines. Accordingly, such medical and scientific phenomena began to be reflected in novels. In particular, Mary Shelley's Frankenstein includes the diverse aspects of the change and development in the medicine and science. Associated with medical and scientific information reflected in Frankenstein and Frankenstein's experiments in the text, accordingly, this research will investigate the aspects of medical and scientific development taking place in the nineteenth century in three ways. First, the medical and scientific development of the nineteenth century has been reviewed by summerizing both the information of alchemy in which Frankenstein shows his interest and the new science in general that M. Waldman introduces in the text. Second, the actual features of medical and scientific development have been examined through some examples of the experimental methods that M. Waldman implicitly uttered to Frankenstein. Third, it has been checked how the medical and scientific development is related to the main issues of mechanism and vitalism which can be explained as principles of life. Even though this research deals with the developmental process of medicine & science and origin & principles of life implied in Mary Shelley's Frankenstein, its significance is that it is the interdisciplinary research focussing on how deeply medical and scientific discourse of Mary Shelley's period has been imbedded in the nineteenth century novel.

Early Patient Access to Medicines: Health Technology Assessment Bodies Need to Catch Up with New Marketing Authorization Methods.

PubMed

Leyens, Lada; Brand, Angela

National and international medicines agencies have developed innovative methods to expedite promising new medicines to the market and facilitate early patient access. Some of these approval pathways are the conditional approval and the adaptive pathways by the European Medicines Agency (EMA); the Promising Innovative Medicine (PIM) designation and the Early Access to Medicines Scheme (EAMS) by the Medicines and Healthcare Products Regulatory Agency (MHRA), as well as the Fast Track, Breakthrough or Accelerated Approval methods by the Food and Drug Administration (FDA). However, at least in Europe, these methods cannot achieve the goal of improving timely access for patients to new medicines on their own; the reimbursement process also has to become adaptive and flexible. In the past 2 years, the effective access (national patient access) to newly approved oncology drugs ranged from 1 to 30 months, with an extremely high variability between European countries. The goal of early patient access in Europe can only be achieved if the national health technology assessment bodies, such as NICE (ENG), HAS (FR), G-BA (DE) or AIFA (IT), provide harmonized, transparent, flexible, conditional and adaptive methods that adopt the level of evidence accepted by the medicines agencies. The efforts from medicines agencies are welcome but will be in vain if health technology assessments do not follow with similar initiatives, and the European 'postcode' lottery will continue. © 2016 S. Karger AG, Basel.

[The inner coherence of psychosomatic medicine].

PubMed

Herrmann-Lingen, Christoph

2012-01-01

The body-mind dualism of somatic medicine is resolved through the concept of psychosomatic medicine. More unspecific descriptions such as "integrative medicine" (which does not clarify what should be integrated) or the "holistic approach" (which comes close to esoterics) suggest the unity of mind, body and soul, although the term "psycho-somatic" still reflects dualistic thinking. The American Psychosomatic Society has been considering a name change for years, partially to rid itself of the dualistic label, but so far these efforts have not resulted in a viable alternative. Engel's concept of biopsychosocial medicine supposes a triangular array of the body, mind, and social environment, setting body and mind into a relationship with each other and with a third party. Based on the physician-patient relationship (Balint), psychosomatic medicine can be understood in a broader sense as "relationship medicine," covering not only the use of the interpersonal relationship as a medical agent, but also a science of medicine that puts mind, body, and social environment into a theoretical framework of interrelations, with the perspective of integrating the different system levels. The translation processes among the system levels are, for example, addressed by biosemiotics (v. Uexküll). Both clinical medicine and medical research, if they intend to be psychosomatic, need to take these theoretical concepts into account and utilize them practically for (team)work with patients. Together with a clear differentiation from other cultures of (para)medicine, this can serve to develop a "psychosomatic identity."

Thinking and practice of accelerating transformation of traditional Chinese medicine from experience medicine to evidence-based medicine.

PubMed

Liu, Baoyan; Zhang, Yanhong; Hu, Jingqing; He, Liyun; Zhou, Xuezhong

2011-06-01

The gradual development of Chinese medicine is based on constant accumulation and summary of experience in clinical practice, but without the benefit of undergoing the experimental medicine stage. Although Chinese medicine has formed a systematic and unique theory system through thousands of years, with the development of evidence-based medicine, the bondage of the research methods of experience medicine to Chinese medicine is appearing. The rapid transition and transformation from experience medicine to evidence-based medicine have become important content in the development of Chinese medicine. According to the features of Chinese medicine, we propose the research idea of "taking two ways simultaneously," which is the study both in the ideal condition and in the real world. Analyzing and constructing the theoretical basis and methodology of clinical research in the real world, and building the stage for research technique is key to the effective clinical research of Chinese medicine. Only by gradually maturing and completing the clinical research methods of the real world could we realize "taking two ways simultaneously" and complementing each other, continuously produce scientific and reliable evidence of Chinese medicine, as well as transform and develop Chinese medicine from experience medicine to evidence-based medicine.

How we developed and piloted an electronic key features examination for the internal medicine clerkship based on a US national curriculum.

PubMed

Bronander, Kirk A; Lang, Valerie J; Nixon, L James; Harrell, Heather E; Kovach, Regina; Hingle, Susan; Berman, Norman

2015-01-01

Key features examinations (KFEs) have been used to assess clinical decision making in medical education, yet there are no reports of an online KFE-based on a national curriculum for the internal medicine clerkship. What we did: The authors developed and pilot tested an electronic KFE based on the US Clerkship Directors in Internal Medicine core curriculum. Teams, with expert oversight and peer review, developed key features (KFs) and cases. The exam was pilot tested at eight medical schools with 162 third and fourth year medical students, of whom 96 (59.3%) responded to a survey. While most students reported that the exam was more difficult than a multiple choice question exam, 61 (83.3%) students agreed that it reflected problems seen in clinical practice and 51 (69.9%) students reported that it more accurately assessed the ability to make clinical decisions. The development of an electronic KFs exam is a time-intensive process. A team approach offers built-in peer review and accountability. Students, although not familiar with this format in the US, recognized it as authentically assessing clinical decision-making for problems commonly seen in the clerkship.

Purity and the dangers of regenerative medicine: regulatory innovation of human tissue-engineered technology.

PubMed

Faulkner, Alex; Kent, Julie; Geesink, Ingrid; FitzPatrick, David

2006-11-01

This paper examines the development of innovation in human tissue technologies as a form of regenerative medicine, firstly by applying 'pollution ideas' to contemporary trends in its risk regulation and to the processes of regulatory policy formation, and secondly by analysing the classificatory processes deployed in regulatory policy. The analysis draws upon data from fieldwork and documentary materials with a focus on the UK and EU (2002-05) and explores four arenas: governance and regulatory policy; commercialisation and the market; 'evidentiality' manifest in evidence-based policy; and publics' and technology users' values and ethics. The analysis suggests that there is a trend toward 'purification' across these arenas, both material and socio-political. A common process of partitioning is found in stakeholders' attempts to define a clear terrain, which the field of tissue-engineered technology might occupy. We conclude that pollution ideas and partitioning processes are useful in understanding regulatory ordering and innovation in the emerging technological zone of human tissue engineering.

A review of postfeeding larval dispersal in blowflies: implications for forensic entomology

NASA Astrophysics Data System (ADS)

Gomes, Leonardo; Godoy, Wesley Augusto Conde; von Zuben, Claudio José

2006-05-01

Immature and adult stages of blowflies are one of the primary invertebrate consumers of decomposing animal organic matter. When the food supply is consumed or when the larvae complete their development and migrate prior to the total removal of the larval substrate, they disperse to find adequate places for pupation, a process known as postfeeding larval dispersal. Several important ecological and physiological aspects of this process were studied since the work by Green (Ann Appl Biol 38:475, 1951) 50 years ago. An understanding of postfeeding larval dispersal can be useful for determining the postmortem interval (PMI) of human cadavers in legal medicine, particularly because this interval may be underestimated if older dispersing larvae or those that disperse longer, faster, and deeper are not taken into account. In this article, we review the process of postfeeding larval dispersal and its implications for legal medicine, in particular showing that aspects such as burial behavior and competition among species of blowflies can influence this process and consequently, the estimation of PMI.

Implementing Competency-Based Medical Education in a Postgraduate Family Medicine Residency Training Program: A Stepwise Approach, Facilitating Factors, and Processes or Steps That Would Have Been Helpful.

PubMed

Schultz, Karen; Griffiths, Jane

2016-05-01

In 2009-2010, the postgraduate residency training program at the Department of Family Medicine, Queen's University, wrestled with the practicalities of competency-based medical education (CBME) implementation when its accrediting body, the College of Family Physicians of Canada, introduced the competency-based Triple C curriculum. The authors used a stepwise approach to implement CMBE; the steps were to (1) identify objectives, (2) identify competencies, (3) map objectives and competencies to learning experiences and assessment processes, (4) plan learning experiences, (5) develop an assessment system, (6) collect and interpret data, (7) adjust individual residents' training programs, and (8) distribute decisions to stakeholders. The authors also note overarching processes, costs, and facil itating factors and processes or steps that would have been helpful for CBME implementation. Early outcomes are encouraging. Residents are being directly observed more often with increased documented feedback about performance based on explicit competency standards (24,000 data points for 150 residents from 2013 to 2015). These multiple observations are being collated in a way that is allowing the identification of patterns of performance, red flags, and competency development trajectory. Outliers are being identified earlier, resulting in earlier individualized modification of their residency training program. The authors will continue to provide and refine faculty development, are developing an entrustable professional activity field note app for handheld devices, and are undertaking research to explore what facilitates learners' competency development, what increases assessors' confidence in making competence decisions, and whether residents are better trained as a result of CBME implementation.

Study of Scientific Production of Community Medicines' Department Indexed in ISI Citation Databases.

PubMed

Khademloo, Mohammad; Khaseh, Ali Akbar; Siamian, Hasan; Aligolbandi, Kobra; Latifi, Mahsoomeh; Yaminfirooz, Mousa

2016-10-01

In the scientometric, the main criterion in determining the scientific position and ranking of the scientific centers, particularly the universities, is the rate of scientific production and innovation, and in all participations in the global scientific development. One of the subjects more involved in repeatedly dealt with science and technology and effective on the improvement of health is medical science fields. In this research using scientometric and citation analysis, we studied the rate of scientific productions in the field of community medicine, which is the numbers of articles published and indexed in ISI database from 2000 to 2010. This study is scientometric using the survey and analytical citation. The study samples included all of the articles in the ISI database from 2000 to 2010. For the data collection, the advance method of searching was used at the ISI database. The ISI analyses software and descriptive statistics were used for data analysis. Results showed that among the five top universities in producing documents, Tehran University of Medical Sciences with 88 (22.22%) documents are allocated to the first rank of scientific products. M. Askarian with 36 (90/9%) published documents; most of the scientific outputs in Community medicine, in the international arena is the most active author in this field. In collaboration with other writers, Iranian departments of Community Medicine with 27 published articles have the greatest participation with scholars of English authors. In the process of scientific outputs, the results showed that the scientific process was in its lowest in the years 2000 to 2004, and while the department of Community medicine in 2009 allocated most of the production process to itself. Iranian Journal of Public Health and Saudi Medical Journal each of them had 16 articles which had most participation rate in the publishing of community medicine's department. On the type of carrier, community medicine's department by presentation of 340(85.86%) articles had presented most of their scientific productions in the format of article, also in the field of community medicine outputs, article entitled: "Iron loading and erythrophagocytosis increase ferroportin 1 (FPN1) expression in J774 macrophages"(1) with 81 citations ranked first in cited articles. Subject areas of occupational health with 70 articles and subject areas of general medicine with 69 articles ranked the most active research areas in the Production of community medicine's department. the obtained data showed the much growth of scientific production. The Tehran University of medical Sciences ranked the first in publishing articles in community medicine's department and with most collaboration with community medicine department of England writers in this field and most writers will present their works in paper format.

From medical tradition to traditional medicine: A Tibetan formula in the European framework.

PubMed

Schwabl, Herbert; Vennos, Cécile

2015-06-05

The increasing prevalence of complex multi-factorial chronic diseases and multimorbidity reveals the need for an enlargement of the therapeutic options. Potent multicompound herbal formulations from traditional medicine systems such as Tibetan Medicine might meet the requirements. With its practice over the centuries Tibetan Medicine is one of the important medical heritages of the world. In the 20th century Tibetan formulas came to Switzerland, where the formula Gabur-25 was then registered as medicine in 1977 (Padma 28, Swissmedic No 35872). The new European directive 2004/24/EC opened the avenue for traditional herbal medicinal products and registrations followed in Austria (HERB-00037) and the UK (39568/0001). The aim of this review was to analyse not only the critical points and hazards but also chances that occur in the endeavour of bringing a ethnopharmacological based preparation to the market within a modern Western medical and regulatory framework and to discuss the necessary transformation steps from a traditional herbal formula towards a modern pharmaceutical product with the example of the Tibetan formula Gabur-25. The historic transformation process from the 19th to the 21st century is analysed, using the registration documents and other material from the library of Padma AG, Hinwil, Switzerland. The transformation of a traditional formula into a modern traditional herbal medicinal product according to the present EU regulations is a multi faceted process. The modern indication represents only a small part of the possible traditional indications. Quality and product labelling has to be adopted to modern standards. The formula, once registered, is a fixed combination of herbal and mineral ingredients. Contrary to this the concept of Asian medical tradition allows a certain flexibility in the composition of an herbal formula. The ingredients are constantly adapted to local conditions, availability of raw material and therapeutic situation. The example shows that in principle complex herbal formulas from Asian medicine can meet the requirements of the European regime of traditional herbal medicinal products. A structured process of transformation from a traditional herbal formula to a modern medicinal product has to include selection of a suitable formula, development of an analytic concept and selection of a suitable indication with regard to the empirical set of possible indications. To extend the range of high quality medicinal products from other medical traditions within the European context the European legislators have to re-evaluate the imposed restrictions given in directive 2004/24/EC. Without amendment of the prerequisite of 15 years documented use in the EU and the limitation of indications for traditional herbal medicinal products, European citizens will be excluded from access to high quality medical traditions with their accumulated empirical knowledge. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

What can family medicine practices do to facilitate knowledge management?

PubMed

Orzano, A John; Ohman-Strickland, Pamela A; Patel, Meghal

2008-01-01

Family medicine practices face increasing demands to enhance efficiency and quality of care. Current solutions propose major practice redesign and investment in sophisticated technology. Knowledge management (KM) is a process that increases the capacity of a practice to deliver effective care by finding and sharing information and knowledge among practice members or by developing new knowledge for use by the practice. Our preliminary research in family medicine practices has suggested improved patient outcomes with greater and more effective KM. Research in other organizational settings has suggested that KM can be facilitated by certain organizational characteristics. To identify those organizational characteristics within a family medicine practice that management can effect to enhance KM. We performed a cross-sectional secondary analysis of second-year data from 13 community family medicine practices participating in a practice improvement project. Practice KM, leaderships' promotion of participatory decision making, existence of activities supportive of human resource processes, and effective communication were derived from clinician's, nurses', and staff's responses to a survey eliciting responses on practice organizational characteristics. Hierarchical linear modeling examined relationships between individual practice members' perception of KM and organizational characteristics of the practice, controlling for practice covariates (solo-group, electronic medical record use, and perception of a chaotic practice environment) and staff-level covariates (gender, age, and role). Practices with greater participatory decision making and human resources' processes and effective communication significantly (p < .019, p < .0001, and p < .004) increased odds of reporting satisfactory KM (odds ratio = 2.48, 95% confidence interval = 1.32-4.65; odds ratio = 10.84, 95% confidence interval = 4.04-29.12; and odds ratio = 4.95, 95% confidence interval = 2.02-12.16). The sizes of these effects were not substantially changed even when practice members perceived their practice environment as more chaotic. Steps to facilitate KM should be considered when evaluating more intensive and costly organizational solutions for enhancing family medicine practice performance.

Regulatory environment for allergen-specific immunotherapy.

PubMed

Kaul, S; May, S; Lüttkopf, D; Vieths, Stefan

2011-06-01

Products for specific immunotherapy (SIT) are medicinal products according to the European Regulations. To obtain a marketing authorization (MA) within the European Community, the quality, safety and efficacy have to be proven. During the development phase of a medicinal product, applicants have the opportunity to apply for scientific advice by national competent authorities or the European Medicines Agency (EMA) to compile a suitable development plan for the examination of quality and performance of nonclinical and clinical trials. Moreover, a paediatric investigation plan has to be submitted to the Paediatric Committee of the EMA and has to be approved before submission of an application for MA. Several regulatory procedures exist for obtaining a MA in the European Community. The national procedure leads only to marketability in one country whereas the Mutual Recognition, the Decentralized and Centralized Procedures (CP) are intended for MA in several or all member states of the European Union. The CP is mandatory for certain medicinal products, for example for drug substances derived by biotechnological processes such as recombinant allergens. Named Patient Products for SIT are a specialty because they are manufactured on the basis of an individual prescription and marketed without a MA. © 2011 John Wiley & Sons A/S.

Overcoming institutional challenges through continuous professionalism improvement: the University of Washington experience.

PubMed

Fryer-Edwards, Kelly; Van Eaton, Erik; Goldstein, Erika A; Kimball, Harry R; Veith, Richard C; Pellegrini, Carlos A; Ramsey, Paul G

2007-11-01

The University of Washington (UW) School of Medicine is in the midst of an emerging ecology of professionalism. This initiative builds on prior work focusing on professionalism at the student level and moves toward the complete integration of a culture of professionalism within the UW medical community of including staff, faculty, residents, and students. The platform for initiating professionalism as institutional culture is the Committee on Continuous Professionalism Improvement, established in November 2006. This article reviews three approaches to organizational development used within and outside medicine and highlights features that are useful for enhancing an institutional culture of professionalism: organizational culture, safety culture, and appreciative inquiry. UW Medicine has defined professional development as a continuous process, built on concrete expectations, using mechanisms to facilitate learning from missteps and highlighting strengths. To this end, the school of medicine is working toward improvements in feedback, evaluation, and reward structures at all levels (student, resident, faculty, and staff) as well as creating opportunities for community dialogues on professionalism issues within the institution. Throughout all the Continuous Professionalism Improvement activities, a two-pronged approach to cultivating a culture of professionalism is taken: celebration of excellence and attention to accountability.

Core Goals and Objectives of the University of Connecticut School of Medicine: The Product and the Process.

ERIC Educational Resources Information Center

Gjerde, Craig L.; Sheehan, T. Joseph

The final report of the University of Connecticut Health Center curriculum project entitled "A Data-Based Approval to Developing a Curriculum" is presented. The aims of the project were these: (1) to develop procedures for judging and cross-judging the goals and objectives of undergraduate medical education; (2) to implement these…

Research and development program, fiscal year 1966

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

Not Available

1964-04-01

The biomedical program of the Laboratory of Nuclear Medicine and Radiation Biology for FY 1966 is conducted within the scope of the following categories: Somatic Effects of Radiation; Combating Detrimental Effects of Radiation; Molecular and Cellular Level Studies; Environmental Radiation Studies; Radiological and Health Physics and Instrumentation; Chemical Toxicity; Cancer Research; and Selected Beneficial Applications. The overall objectives of the Laboratory within these areas of the Biology and Medicine program may be summarized as follows: (1) investigation of the effects of ionizing radiation on living organisms and systems of biological significance; (2) investigation of the dynamic aspects of physiological andmore » biochemical processes in man, animals and plants and how these processes are modified by radiation and related pathological states; (3) the assessment and study of the immediate and long term consequences of the operation or detonation of nuclear devices on the fauna, and flora in man's environment and on man; (4) the development of methods of minimizing or preventing the detrimental effects of ionizing radiation; (5) research in, and development of, beneficial uses of ionizing radiation and radioactive substances in medicine and biology; (6) research in the development of new and more efficient radiation detection devices; (7) research, including field studies, as mutually agreed upon by the Commission and the University, in connection with the conduct of weapon tests and biomedical and civil effects experiments at such tests conducted at continental and overseas test sites; and (8) the conduct of training and educational activities in the biological and medical aspects of radiation and related fields.« less

[Investigation on production process quality control of traditional Chinese medicine--Banlangen granule as an example].

PubMed

Tan, Manrong; Yan, Dan; Qiu, Lingling; Chen, Longhu; Yan, Yan; Jin, Cheng; Li, Hanbing; Xiao, Xiaohe

2012-04-01

For the quality management system of herbal medicines, intermediate and finished products it exists the " short board" effect of methodologies. Based on the concept of process control, new strategies and new methods of the production process quality control had been established with the consideration of the actual production of traditional Chinese medicine an the characteristics of Chinese medicine. Taking Banlangen granule as a practice example, which was effective and widespread application, character identification, determination of index components, chemical fingerprint and biometrics technology were sequentially used respectively to assess the quality of Banlangen herbal medicines, intermediate (water extraction and alcohol precipitation) and finished product. With the transfer rate of chemical information and biological potency as indicators, the effectiveness and transmission of the above different assessments and control methods had been researched. And ultimately, the process quality control methods of Banlangen granule, which were based on chemical composition analysis-biometric analysis, had been set up. It can not only validly solute the current status that there were many manufacturers varying quality of Banlangen granule, but also ensure and enhance its clinical efficacy. Furthermore it provided a foundation for the construction of the quality control of traditional Chinese medicine production process.

The innovations in science and technology as a demand for bio-better medicines in Europe.

PubMed

Demetzos, Costas

2015-01-01

The purpose of this review is to address the role of the scientific excellence of innovative medicines as the key element in the development process in Greece. The collected statistical information and data on the absorbability of funds for research of innovative medicines, diagnostics, and advanced drug delivery systems pointed out that the Greek scientists could take advantage of the "Horizon 2020" on the continuity of their investigation, whilst how the accumulation of knowledge at Greek universities and research foundations could be translated into industrial products with added value, safe and effective for the European consumers. In conclusion, this review also is considered to provide the potential benefits in order to adapt the signaling of the "Horizon 2020" for the development of a bio-better Europe based on scientific inspirations. This approach could be considered as an interplay between countries and even between the north and west located countries in the European landscape.

Q-marker based strategy for CMC research of Chinese medicine: A case study of Panax Notoginseng saponins.

PubMed

Zhong, Yi; Zhu, Jieqiang; Yang, Zhenzhong; Shao, Qing; Fan, Xiaohui; Cheng, Yiyu

2018-01-31

To ensure pharmaceutical quality, chemistry, manufacturing and control (CMC) research is essential. However, due to the inherent complexity of Chinese medicine (CM), CMC study of CM remains a great challenge for academia, industry, and regulatory agencies. Recently, quality-marker (Q-marker) was proposed to establish quality standards or quality analysis approaches of Chinese medicine, which sheds a light on Chinese medicine's CMC study. Here manufacture processes of Panax Notoginseng Saponins (PNS) is taken as a case study and the present work is to establish a Q-marker based research strategy for CMC of Chinese medicine. The Q-markers of Panax Notoginseng Saponins (PNS) is selected and established by integrating chemical profile with pharmacological activities. Then, the key processes of PNS manufacturing are identified by material flow analysis. Furthermore, modeling algorithms are employed to explore the relationship between Q-markers and critical process parameters (CPPs) of the key processes. At last, CPPs of the key processes are optimized in order to improving the process efficiency. Among the 97 identified compounds, Notoginsenoside R 1 , ginsenoside Rg 1 , Re, Rb 1 and Rd are selected as the Q-markers of PNS. Our analysis on PNS manufacturing show the extraction process and column chromatography process are the key processes. With the CPPs of each process as the inputs and Q-markers' contents as the outputs, two process prediction models are built separately for the extraction process and column chromatography process of Panax notoginseng, which both possess good prediction ability. Based on the efficiency models of extraction process and column chromatography process we constructed, the optimal CPPs of both processes are calculated. Our results show that the Q-markers derived from CMC research strategy can be applied to analyze the manufacturing processes of Chinese medicine to assure product's quality and promote key processes' efficiency simultaneously. Copyright © 2018 Elsevier GmbH. All rights reserved.

Research scholars program: a faculty development initiative at the Oregon College of Oriental Medicine.

PubMed

Hammerschlag, Richard; Lasater, Kathie; Salanti, Sonya; Fleishman, Susan

2008-05-01

The Research Scholars Program (RSP) was created at the Oregon College of Oriental Medicine (OCOM) to provide faculty development in research literacy, research-informed clinical practice, and research participation skills. The RSP is part of a broad effort, funded by a National Institutes of Health/National Center for Complementary and Alternative Medicine R25 education grant, to infuse an evidence-based perspective into the curriculum at schools of complementary and alternative medicine. The RSP arose from the realization that this curriculum reform would first necessitate faculty training in both research appreciation and pedagogy. OCOM's grant, Acupuncture Practitioner Research Education Enhancement, is a partnership with the Oregon Health & Science University School of Nursing (OHSU SON). The RSP was developed initially as a collaborative effort among the OCOM Dean of Research (R.H.), OCOM Director of Research Education (S.F.), and an OHSU SON education specialist (K.L.). The 9-month, 8 hours per month seminar-style RSP provides the opportunity for a cohort of OCOM faculty and staff to explore research-related concepts and content as well as pedagogical practices that emphasize interactive, learner-centered teaching. The RSP adheres to a competency-based approach as developed by the Education Committee of the grant. As a tangible outcome, each Research Scholar designs a sustainable learning activity that infuses a research perspective into their courses, clinic supervision, or other sphere of influence at the college. In this paper, we describe the creative process and the lessons learned during the planning and initial implementation of the RSP. We view the early successes of the RSP as encouraging signs that research literacy and an evidence-based perspective are becoming increasingly accepted as needed skill sets for present-day practitioners of acupuncture and Oriental medicine.

Development of advanced therapies in Italy: Management models and sustainability in six Italian cell factories.

PubMed

Gaipa, Giuseppe; Introna, Martino; Golay, Josee; Nolli, Maria Luisa; Vallanti, Giuliana; Parati, Eugenio; Giordano, Rosaria; Romagnoli, Luca; Melazzini, Mario; Biondi, Andrea; Biagi, Ettore

2016-04-01

On November 10, 2014, the representatives of all six certified Good Manufacturing Practices (GMP) cell factories operating in the Lombardy Region of Italy convened a 1-day workshop in Milan titled "Management Models for the Development And Sustainability of Cell Factories: Public-Private Partnership?" The speakers and panelists addressed not only the many scientific, technological and cultural challenges faced by Lombardy Cell Factories, but also the potential impact of advanced therapy medicinal products (ATMPs) on public health and the role played by translational research in this process. Future perspectives for research and development (R&D) and manufacturing processes in the field of regenerative medicine were discussed as well. This report summarizes the most important issues raised by the workshop participants with particular emphasis on strengths and limitations of the R&D and manufacturing processes for innovative therapeutics in Lombardy and what can be improved in this context while maintaining GMP standards. The participants highlighted several strategies to translate patient-specific advanced therapeutics into scaled manufacturing products for clinical application. These included (i) the development of a synergistic interaction between public and private institutions, (ii) better integration with Italian regulatory agencies and (iii) the creation of a network among Lombardy cell factories and other Italian and European institutions. Copyright © 2016 International Society for Cellular Therapy. Published by Elsevier Inc. All rights reserved.

Expectations and responsibilities regarding the sale of complementary medicines in pharmacies: perspectives of consumers and pharmacy support staff.

PubMed

Iyer, Priya; McFarland, Reanna; La Caze, Adam

2017-08-01

Most sales of complementary medicines within pharmacies are conducted by pharmacy support staff. The absence of rigorous evidence for the effectiveness of many complementary medicines raises a number of ethical questions regarding the sale of complementary medicines in pharmacies. Explore (1) what consumers expect from pharmacists/pharmacies with regard to the sale of complementary medicines, and (2) how pharmacy support staff perceive their responsibilities when selling complementary medicines. One-on-one semi-structured interviews were conducted with a convenience sample of pharmacy support staff and consumers in pharmacies in Brisbane. Consumers were asked to describe their expectations when purchasing complementary medicines. Pharmacy support staff were asked to describe their responsibilities when selling complementary medicines. Interviews were conducted and analysed using the techniques developed within Grounded Theory. Thirty-three consumers were recruited from three pharmacies. Consumers described complementary medicine use as a personal health choice. Consumer expectations on the pharmacist included: select the right product for the right person, expert product knowledge and maintaining a wide range of good quality stock. Twenty pharmacy support staff were recruited from four pharmacies. Pharmacy support staff employed processes to ensure consumers receive the right product for the right person. Pharmacy support staff expressed a commitment to aiding consumers, but few evaluated the reliability of effectiveness claims regarding complementary medicines. Pharmacists need to respect the personal health choices of consumers while also putting procedures in place to ensure safe and appropriate use of complementary medicines. This includes providing appropriate support to pharmacy support staff. © 2016 Royal Pharmaceutical Society.

[Summary of Hui prescriptions for treating cough].

PubMed

Zhang, Wen-jin; Liu, Yue; Zhang, Xin-hui

2015-02-01

In this study, by using the method of literature research, 35 prescriptions related to asthma therapy has been screened out from Hui medicine through collecting the ancient and modern literature. A comparison of fragrant medicine between the name in Arab and Chinese herbal medicine is done. The countif function in Microsoft Excel 2007 is used to get the prescriptions of the drug on the frequency statistics, summarizing the common drugs of Hui medicine for asthma are Pinellia, almond, white sugar, walnut. According to the commonly used drugs, the pathogeny and treatment principle about Hui medicine for asthma is preliminarily inferred combining literature research and the related Hui medical theory. In this study, those prescriptions have been classified into 21 cases which are effective and can be used in medical therapy according to the relevant literatures with the development of the Hui people in their long process of formation of the unique diet culture, 14 useful and convenient Halal diet therapies are made up according to the indications, therapies, party name and composition. Halal diet and "medicine and food" herbs are preliminarily analyzed and summarized, which can be convenient for the people to reduce pains through the diet and improve health awareness.

Perspectives in molecular imaging through translational research, human medicine, and veterinary medicine.

PubMed

Berry, Clifford R; Garg, Predeep

2014-01-01

The concept of molecular imaging has taken off over the past 15 years to the point of the renaming of the Society of Nuclear Medicine (Society of Nuclear Medicine and Molecular Imaging) and Journals (European Journal of Nuclear Medicine and Molecular Imaging) and offering of medical fellowships specific to this area of study. Molecular imaging has always been at the core of functional imaging related to nuclear medicine. Even before the phrase molecular imaging came into vogue, radionuclides and radiopharmaceuticals were developed that targeted select physiological processes, proteins, receptor analogs, antibody-antigen interactions, metabolites and specific metabolic pathways. In addition, with the advent of genomic imaging, targeted genomic therapy, and theranostics, a number of novel radiopharmaceuticals for the detection and therapy of specific tumor types based on unique biological and cellular properties of the tumor itself have been realized. However, molecular imaging and therapeutics as well as the concept of theranostics are yet to be fully realized. The purpose of this review article is to present an overview of the translational approaches to targeted molecular imaging with application to some naturally occurring animal models of human disease. © 2013 Published by Elsevier Inc.

The effect of a required third-year family medicine clerkship on medical students' attitudes: value indoctrination and value clarification.

PubMed

Senf, J H; Campos-Outcalt, D

1995-02-01

The effect of a required six-week third-year family medicine clerkship was examined within a framework of professional socialization. Socialization was considered to consist of an institutional process, i.e., value indoctrination, and a learner process, i.e., value clarification. Pre- and postclerkship data from 1,095 students (classes of 1981-1993) at the University of Arizona College of Medicine were analyzed. In addition, specialty match data were obtained. Factor analysis of 19 items on the pre- and postclerkship questionnaires was used to derive four scales measuring attitudes related to family medicine. The students were first grouped into four groups: those who preferred family medicine before and after the clerkship, those who preferred other specialties both times, those who switched to family medicine, and those who switched away from family medicine. Then the students were grouped into eight groups by dividing each of the specialty-preference groups into two sections: those who matched to family medicine and those who did not. Statistical comparisons involved the use of the t and F statistics. Usable data were available for a maximum of 997 students (91%). The students' attitudes about family medicine changed during the clerkship to become more consistent with their postclerkship specialty preferences. In addition, more students preferred family medicine after the clerkship than before it. When each group was further divided into those matching and not matching into family medicine, no significant difference in attitudes was found between those matching and those not matching. These results reflect both a value clarification process and a value indoctrination effect. The discrepancy between postclerkship specialty preferences and later match data indicates that the indoctrination effect and clarification process continue into the fourth year.

Interactive brain shift compensation using GPU based programming

NASA Astrophysics Data System (ADS)

van der Steen, Sander; Noordmans, Herke Jan; Verdaasdonk, Rudolf

2009-02-01

Processing large images files or real-time video streams requires intense computational power. Driven by the gaming industry, the processing power of graphic process units (GPUs) has increased significantly. With the pixel shader model 4.0 the GPU can be used for image processing 10x faster than the CPU. Dedicated software was developed to deform 3D MR and CT image sets for real-time brain shift correction during navigated neurosurgery using landmarks or cortical surface traces defined by the navigation pointer. Feedback was given using orthogonal slices and an interactively raytraced 3D brain image. GPU based programming enables real-time processing of high definition image datasets and various applications can be developed in medicine, optics and image sciences.

Emerging role of Twist1 in fibrotic diseases.

PubMed

Ning, Xiaoxuan; Zhang, Kun; Wu, Qingfeng; Liu, Minna; Sun, Shiren

2018-03-01

Epithelial-mesenchymal transition (EMT) is a pathological process that occurs in a variety of diseases, including organ fibrosis. Twist1, a basic helix-loop-helix transcription factor, is involved in EMT and plays significant roles in various fibrotic diseases. Suppression of the EMT process represents a promising approach for the treatment of fibrotic diseases. In this review, we discuss the roles and the underlying molecular mechanisms of Twist1 in fibrotic diseases, including those affecting kidney, lung, skin, oral submucosa and other tissues. We aim at providing new insight into the pathogenesis of various fibrotic diseases and facilitating the development of novel diagnostic and therapeutic methods for their treatment. © 2018 The Authors. Journal of Cellular and Molecular Medicine published by John Wiley & Sons Ltd and Foundation for Cellular and Molecular Medicine.

[Research progress on potential liver toxic components in traditional Chinese medicine].

PubMed

Wu, Hao; Zhong, Rong-Ling; Xia, Zhi; Huang, Hou-Cai; Zhong, Qing-Xiang; Feng, Liang; Song, Jie; Jia, Xiao-Bin

2016-09-01

In recent years, the proportion of traditional Chinese medicine in scientific research and its clinical use increased gradually. The research result also becomes more and more valuable, but in the process of using traditional Chinese medicine, it also needs to pay more attention. With the gradual deepening of the toxicity of traditional Chinese medicine, some traditional Chinese medicines have also been found to have the potential toxicity, with the exception of some traditional toxicity Chinese medicine. Traditional Chinese medicine in the growth, processing, processing, transportation and other aspects of pollution or deterioration will also cause the side effects to the body. Clinical practice should be based on the theory of traditional Chinese medicine to guide rational drug use and follow the symptomatic medication, the principle of proper compatibility. The constitution of the patients are different, except for a few varieties of traditional Chinese medicines are natural herbs with hepatotoxicity, liver toxicity of most of the traditional Chinese medicine has idiosyncratic features. The liver plays an important role in drug metabolism. It is easy to be damaged by drugs. Therefore, the study of traditional Chinese medicine potential liver toxicity and its toxic components has become one of the basic areas of traditional Chinese medicine research. Based on the review of the literatures, this paper summarizes the clinical classification of liver toxicity, the pathogenesis of target cell injury, and systematically summarizes the mechanism of liver toxicity and toxic mechanism of traditional Chinese medicine. This paper provided ideas for the study of potential liver toxicity of traditional Chinese medicine and protection for clinical safety of traditional Chinese medicine. Copyright© by the Chinese Pharmaceutical Association.

[Industry of traditional Chinese patent medicine science and technology development and review].

PubMed

Lu, Jianwei; Wang, Fang; Yan, Dongmei; Luo, Yun; Yang, Ming

2012-01-01

"Fifteen" since, our country Chinese traditional medicine industry science and technology has made remarkable achievements. In this paper, the development of science and technology policy, Chinese medicine industry, platform construction and other aspects were analyzed, showing 10 years of Chinese traditional medicine industry development of science and technology innovation achievement and development, and on the current development of traditional Chinese medicine industry facing the main tasks and guarantee measures are analyzed.

Recent advances in basic and clinical nanomedicine.

PubMed

Morrow, K John; Bawa, Raj; Wei, Chiming

2007-09-01

Nanomedicine is a global business enterprise. Industry and governments clearly are beginning to envision nanomedicine's enormous potential. A clear definition of nanotechnology is an issue that requires urgent attention. This problem exists because nanotechnology represents a cluster of technologies, each of which may have different characteristics and applications. Although numerous novel nanomedicine-related applications are under development or nearing commercialization, the process of converting basic research in nanomedicine into commercially viable products will be long and difficult. Although realization of the full potential of nanomedicine may be years or decades away, recent advances in nanotechnology-related drug delivery, diagnosis, and drug development are beginning to change the landscape of medicine. Site-specific targeted drug delivery and personalized medicine are just a few concepts that are on the horizon.

Task Force 1. Report of the Task Force on Patient Expectations, Core Values, Reintegration, and the New Model of Family Medicine

PubMed Central

Green, Larry A.; Graham, Robert; Bagley, Bruce; Kilo, Charles M.; Spann, Stephen J.; Bogdewic, Stephen P.; Swanson, John

2004-01-01

BACKGROUND To lay the groundwork for the development of a comprehensive strategy to transform and renew the specialty of family medicine, this Future of Family Medicine task force was charged with identifying the core values of family medicine, developing proposals to reform family medicine to meet consumer expectations, and determining systems of care to be delivered by family medicine in the future. METHODS A diverse, multidisciplinary task force representing a broad spectrum of perspectives and expertise analyzed and discussed published literature; findings from surveys, interviews, and focus groups compiled by research firms contracted to the Future of Family Medicine project; and analyses from The Robert Graham Center, professional societies in the United States and abroad, and others. Through meetings, conference calls, and writing, and revision of a series of subcommittee reports, the entire task force reached consensus on its conclusions and recommendations. These were reviewed by an external panel of experts and revisions were made accordingly. MAJOR FINDINGS After delivering on its promise to reverse the decline of general practice in the United States, family medicine and the nation face additional challenges to assure all people receive care that is safe, effective, patient-centered, timely, efficient, and equitable. Challenges the discipline needs to address to improve family physicians’ ability to make important further contributions include developing a broader, more accurate understanding of the specialty among the public and other health professionals, addressing the wide scope and variance in practice types within family medicine, winning respect for the specialty in academic circles, making family medicine a more attractive career option, and dealing with the perception that family medicine is not solidly grounded in science and technology. The task force set forth a proposed identity statement for family medicine, a basket of services that should be reliably provided in family medicine practices, and an itemization of key attributes and core values that define the specialty. It also proposed and described a New Model of family medicine for people of all ages and both genders that emphasizes patient-centered, evidence-based, whole-person care provided through a multidisciplinary team approach in settings that reduce barriers to access and use advanced information systems and other new technologies. The task force recommended a time of active experimentation to redesign the work and workplace of family physicians; the development of revised financial models for family medicine, and a national resource to provide assistance to individual practices moving to New Model practice; and cooperation with others pursuing the transformation of frontline medicine to better serve the public. CONCLUSIONS Unless there are changes in the broader health care system and within the specialty, the position of family medicine in the United States will be untenable in a 10- to 20-year time frame. Even within the constraints of today’s flawed health care system, there are major opportunities for family physicians to realize improved results for patients and economic success. A period of aggressive experimentation and redevelopment of family medicine is needed now. The future success of the discipline and its impact on public well-being depends in large measure on family medicine’s ability to rearticulate its vision and competencies in a fashion that has greater resonance with the public while substantially revising the organization and processes by which care is delivered. When accomplished, family physicians will achieve more fully the aspirations articulated by the specialty’s core values and contribute to the solution of the nation’s serious health care problems.

The American Society of Regional Anesthesia and Pain Medicine, the European Society of Regional Anaesthesia and Pain Therapy, and the Asian Australasian Federation of Pain Societies Joint Committee recommendations for education and training in ultrasound-guided interventional pain procedures.

PubMed

Narouze, Samer N; Provenzano, David; Peng, Philip; Eichenberger, Urs; Lee, Sang Chul; Nicholls, Barry; Moriggl, Bernhard

2012-01-01

The use of ultrasound in pain medicine for interventional axial, nonaxial, and musculoskeletal pain procedures is rapidly evolving and growing. Because of the lack of specialty-specific guidelines for ultrasonography in pain medicine, an international collaborative effort consisting of members of the Special Interest Group on Ultrasonography in Pain Medicine from the American Society of Regional Anesthesia and Pain Medicine, the European Society of Regional Anaesthesia and Pain Therapy, and the Asian Australasian Federation of Pain Societies developed the following recommendations for education and training in ultrasound-guided interventional pain procedures. The purpose of these recommendations is to define the required skills for performing ultrasound-guided pain procedures, the processes for appropriate education, and training and quality improvement. Training algorithms are outlined for practice- and fellowship-based pathways. The previously published American Society of Regional Anesthesia and Pain Medicine and European Society of Regional Anaesthesia and Pain Therapy education and teaching recommendations for ultrasound-guided regional anesthesia served as a foundation for the pain medicine recommendations. Although the decision to grant ultrasound privileges occurs at the institutional level, the committee recommends that the training guidelines outlined in this document serve as the foundation for educational training and the advancement of the practice of ultrasonography in pain medicine.

Shoestring budgets, band-AIDS, and team work: challenges and motivators in the development of a Web-based resource for undergraduate clinical skills teaching.

PubMed

Simmons, Collan; Nyhof-Young, Joyce; Bradley, John

2005-05-24

Learning how to conduct a medical interview and perform a physical examination is fundamental to the practice of medicine; however, when this project began, the methods used to teach these skills to medical students at the University of Toronto (U of T) had not changed significantly since the early 1990s despite increasing outpatient care, shorter hospital stays, and heavy preceptor workloads. In response, a Web-based clinical skills resource was developed for the first-year undergraduate medical course-The Art and Science of Clinical Medicine I (ASCM I). This paper examines our experiences with the development of the ASCM I website and details the challenges and motivators inherent in the production of a Web-based, multimedia medical education tool at a large Canadian medical school. Interviews and a focus group were conducted with the development team to discover the factors that positively and negatively affected the development process. Motivating factors included team attributes such as strong leadership and judicious use of medical students and faculty volunteers as developers. Other motivators included a growing lack of instructional equivalency across diverse clinical teaching sites and financial and resource support by the Faculty of Medicine. Barriers to development included an administrative environment that did not yet fully incorporate information technology into its teaching vision and framework, a lack of academic incentive for faculty participation, and inadequate technical support, space, and equipment. The success of electronic educational resources such as the ASCM I website has caused a significant cultural shift within the Faculty of Medicine, resulting in the provision of more space, resources, and support for IT endeavours in the undergraduate medical curriculum.

Use of big data in drug development for precision medicine

PubMed Central

Kim, Rosa S.; Goossens, Nicolas; Hoshida, Yujin

2016-01-01

Summary Drug development has been a costly and lengthy process with an extremely low success rate and lack of consideration of individual diversity in drug response and toxicity. Over the past decade, an alternative “big data” approach has been expanding at an unprecedented pace based on the development of electronic databases of chemical substances, disease gene/protein targets, functional readouts, and clinical information covering inter-individual genetic variations and toxicities. This paradigm shift has enabled systematic, high-throughput, and accelerated identification of novel drugs or repurposed indications of existing drugs for pathogenic molecular aberrations specifically present in each individual patient. The exploding interest from the information technology and direct-to-consumer genetic testing industries has been further facilitating the use of big data to achieve personalized Precision Medicine. Here we overview currently available resources and discuss future prospects. PMID:27430024

[Are investment activity and backlog in investments risks for university medicine in Germany?].

PubMed

Amann, I; Heyder, R; Strehl, R

2009-08-01

University medicine in Germany requires significantly higher funding and investment because its tasks not only include health care but also research and teaching. However, over recent decades less and less funding compared to the development of the turnover has been available. This trend is due to decreasing public funding. The diminishing funding has caused a major backlog of investment at German university hospitals. The first part of the article summarizes the investments policies at university hospitals and other hospitals. The second part describes the investment needs in university medicine and exposes risk factors for research, education and health care due to the process of investment planning and realization. Goal-oriented solutions are shown to facilitate investments. The third part discusses several risks caused by insufficient investments in university medicine. There are special risks for research, teaching, and the capacity for innovation in university medicine besides economical and medical risks. Some policies and financial strategies to overcome the backlog in investments are presented. After a summary, the article concludes with some practical examples of further measures to ensure sustainable funding.

An overview of the European Organization for External Quality Assurance Providers in Laboratory Medicine (EQALM)

PubMed Central

Stavelin, Anne; Albe, Xavier; Meijer, Piet; Sarkany, Erika; MacKenzie, Finlay

2017-01-01

The European Organisation for External Quality Assurance Providers in Laboratory Medicine (EQALM) was founded in 1996 and currently has members from 29 European countries and 6 countries from outside Europe. EQALM provides a forum for co-operation and exchange of knowledge on quality-related matters in laboratory medicine, especially with regard to external quality assessment (EQA) programs in Europe. In addition, EQALM represent the EQA providers in laboratory medicine at European level vis-ŕ-vis political, professional, scientific and other bodies, including patients’ organisations. To this end EQALM promotes activities such as organizing meetings with scientific and practical themes for members and other interested parties, issuing scientific publications, developing EQA projects and representing laboratory medicine EQA activities within other organisations and networks. EQALM is active in scientific and educational activity in different fields such as survey frequency, haematology, haemostasis, microbiology, nomenclature, virtual microscopy, traceability, accreditation, and quality assurance of the total testing process. The aim of this paper is to give an overview of the EQALM organisation. PMID:28392724

[Industry-Academia Collaboration in the Clinical Laboratory Field: Chairmen's Introductory Remarks].

PubMed

Inaba, Tohru; Ikemoto, Toshiyuki

2016-01-01

Industry-academia collaboration has become essential in contemporary medicine. Therefore, many institutes including university corporations have promoted the establishment of an endowed chair and/or performed collaborative research. This symposium was held to overview the present status of industry-academia collaboration in the clinical laboratory field. As a representative of the industry, Mr. Taniguchi (Sysmex) presented the development process of M2BP Glycosylation Isomer, a new marker for liver fibrosis. Mr. Saitoh (Horiba) introduced the achievements of joint collaborative research with Kyoto Prefectural University of Medicine, especially the practical realization of an automated hematology analyzer capable of simultaneously measuring C-reactive protein. Mr. Setoyama (LSI Medience) presented on the characteristic collaboration between academia and commercial laboratories such as Tsukuba Medical Laboratory of Education and Research (TMER). On the other hand, as a representative of academia, Associate Prof. Imai (Kyoto Prefectural University of Medicine) summarized the necessity of clinical laboratories spread regenerative medicine. Finally, Prof. Koshiba (Hyogo College of Medicine) presented on the industry-academia collaboration in routine laboratory work in his institute.

[Current trends in using PET radiopharmaceuticals for diagnostics in oncology].

PubMed

Adam, J; Kadeřávek, J; Kužel, F; Vašina, J; Rehák, Z

2014-01-01

Nuclear medicine is an important field of modern medicine, particularly thanks to its role in in vivo imaging of important processes in human organism. This is possible thanks to the use of radiopharmaceuticals, specific substances labeled by radioactive nuclide, its distribution in the body can be visualized by specialized scanners and, based on the knowledge of physiological patterns, dia-gnosis can be determined. Positron emission tomography (PET) is a modern and in many ways indispensable method of nuclear medicine. The spectrum of radiopharmaceuticals available in recent years is broadening thanks to a coordinated effort of manufacturers of synthesis equipment, chemists and potential users -  physicians. This review focuses on the development in the PET radiopharmaceutical field in the last five years, with an emphasis on oncological applications of PET.

“Neither of meate nor drinke, but what the Doctor alloweth”:

PubMed Central

Chakrabarti, Pratik

2006-01-01

Madras in the eighteenth century was a site of continuous warfare sparked mostly by trading interests. This paper studies how these influences of hostility and commerce shaped the medical establishment of the English East India Company. It begins by analyzing the struggle of the medical establishment to cope with military and logistical requirements; it then shows how the Coromandel trade provided a peculiar dynamic to the practice of medicine in Madras. By aligning the history of medicine with that of trade, the paper traces the parallel trajectories of intellectual and material wealth. The development of modern medicine is seen as a process of adjusting to and engaging with diverse ideas and items—sometimes co-opting them, sometimes realigning them in new modes of production. PMID:16549880

Electrospun Silk Biomaterial Scaffolds for Regenerative Medicine

PubMed Central

Zhang, Xiaohui; Reagan, Michaela R; Kaplan, David L.

2009-01-01

Electrospinning is a versatile technique that enables the development of nanofiber-based biomaterial scaffolds. Scaffolds can be generated that are useful for tissue engineering and regenerative medicine since they mimic the nanoscale properties of certain fibrous components of the native extracellular matrix in tissues. Silk is a natural protein with excellent biocompatibility, remarkable mechanical properties as well as tailorable degradability. Integrating these protein polymer advantages with electrospinning results in scaffolds with combined biochemical, topographical and mechanical cues with versatility for a range of biomaterial, cell and tissue studies and applications. This review covers research related to electrospinning of silk, including process parameters, post treatment of the spun fibers, functionalization of nanofibers, and the potential applications for these material systems in regenerative medicine. Research challenges and future trends are also discussed. PMID:19643154

Aid conditionalities, international Good Manufacturing Practice standards and local production rights: a case study of local production in Nepal.

PubMed

Brhlikova, Petra; Harper, Ian; Subedi, Madhusudan; Bhattarai, Samita; Rawal, Nabin; Pollock, Allyson M

2015-06-14

Local pharmaceutical production has been endorsed by the WHO as a means of addressing health priorities of developing countries. However, local producers of essential medicines must comply with international pharmaceutical standards in order to be eligible to compete in donor tenders. These standards determine production rights for on-patent and off-patent medicines, and guide international procurement of medicines. We reviewed the literature on the impact of Good Manufacturing Practice (GMP) on local production; a gap analysis from the literature review indicated a need for further research. Over sixty interviews were conducted with people involved in the Nepali pharmaceutical production and distribution chain from 2006 to 2009 on the GMP areas of relevance: regulatory capacity, staffing, funding and training, resourcing of GMP, inspectors' interpretation of the rules and compliance. Although Nepal producers have increased their overall share of the domestic market, only the public manufacturer, Royal Drugs, focuses on medicines for public health programmes; private producers engage mainly in brand competition for private markets, not essential medicines. Nepali regulators and producers state that implementation of GMP standards is hindered by low regulatory capacity, insufficient training of staff in the industry, financial constraints and lack of investment for upgrading capital. The transition period to mandatory compliance with WHO GMP rules is lengthy. Less than half of private producers had WHO GMP in 2013. Producers are not directly affected by international harmonisation of standards as they do not export medicines and the Nepali regulator does not enforce the WHO standards strictly. Without an international GMP certificate they cannot tender for donor dependent health programmes. In Nepal, local private manufacturers focus mainly on brand competition for private consumption not essential medicines, the government preferentially procures essential medicines from the only public producer while donor funded programmes rely on international manufacturers compliant with international GMP standards. We also found evidence of private hospitals bypassing national medicines approvals process. Policies in support of local pharmaceutical production in developing countries as a source of essential medicines need to examine carefully how GMP regulations impact on regulators, local industry and production of essential medicines in practice.

Performing 'pragmatic holism': Professionalisation and the holistic discourse of non-medically qualified acupuncturists and homeopaths in the United Kingdom.

PubMed

Givati, Assaf

2015-01-01

Complementary and alternative medicine practitioners have often utilised 'holism' as a key identification mark of their practice, distancing themselves from 'the reductionist biomedicine'. However, the past couple of decades have witnessed increased engagement of several complementary and alternative medicines in professionalisation, which includes a degree of biomedical alignment while 'reducing' holistic claims in order to provide practice with a 'credible outlook' and move closer to the mainstream, a development which challenges the role of holism in complementary and alternative medicine practices. This article explores the strategies by which two groups of complementary and alternative medicine practitioners, namely, non-medically qualified acupuncturists and homeopaths in the United Kingdom, pragmatically accommodate holistic notions as a professional resource, a process of negotiation between maintaining their holistic premise, on the one hand, and the drive to professionalise and enhance their societal status, on the other. Based on in-depth interviews with non-medically qualified acupuncture and homeopathy practitioners and school principals, textual analysis of practitioners' web sites and observation of practice, the findings demonstrate the dynamic approach to 'holism' in complementary and alternative medicine practice. This discourse, through which practitioners use a range of strategies in order to 'narrow' or 'expand' their holistic expression, can be described as 'pragmatic holism', by which they try to make gains from the formalisation/standardisation processes, without losing the therapies' holistic outlook and appeal. © The Author(s) 2014.

Clinical Holistic Medicine: Chronic Infections and Autoimmune Diseases

PubMed Central

Ventegodt, Søren; Merrick, Joav

2005-01-01

The consciousness-based (holistic) medical toolbox might be useful in general practice and in cases of recurrent infections and chronic infection or inflammation. From our clinical experiences, there is hope for improvement from a number of diseases caused by disorders affecting the regulation of the immune system when the physician includes the holistic medical approach.Our scientific understanding of the connection between consciousness and cellular order is still limited. Consciousness-based holistic medicine removes (as explained by the holistic process theory of healing) the “blockages” in the tissues of the body and facilitates function and informational exchange of the cells of the body. Many blockages and repressed feelings in an area would imply “noise and disturbances” on the level of intercellular communications, which in turn means major difficulties for the cells of the immune system. For this they are totally dependent on the body information system, which the holistic treatment aims to recover. Processing the blockages increases the coherence of the cells and organism, thus increasing the intercellular flow of information in the area and thus strengthening the immune defense and healing the disease. The area of clinical holistic medicine is going through a rapid development and the toolbox of consciousness-based medicine is available for dealing with many diseases arising from disturbances in the regulation of the immune system. Holistic medicine has yet to be better explained scientifically and our proposed holistic cures have yet to be documented clinically. We invite the medical community to cooperate on this important challenge. PMID:15759081

Year-End Clinic Handoffs: A National Survey of Academic Internal Medicine Programs.

PubMed

Phillips, Erica; Harris, Christina; Lee, Wei Wei; Pincavage, Amber T; Ouchida, Karin; Miller, Rachel K; Chaudhry, Saima; Arora, Vineet M

2017-06-01

While there has been increasing emphasis and innovation nationwide in training residents in inpatient handoffs, very little is known about the practice and preparation for year-end clinic handoffs of residency outpatient continuity practices. Thus, the latter remains an identified, yet nationally unaddressed, patient safety concern. The 2014 annual Association of Program Directors in Internal Medicine (APDIM) survey included seven items for assessing the current year-end clinic handoff practices of internal medicine residency programs throughout the country. Nationwide survey. All internal medicine program directors registered with APDIM. Descriptive statistics of programs and tools used to formulate a year-end handoff in the ambulatory setting, methods for evaluating the process, patient safety and quality measures incorporated within the process, and barriers to conducting year-end handoffs. Of the 361 APDIM member programs, 214 (59%) completed the Transitions of Care Year-End Clinic Handoffs section of the survey. Only 34% of respondent programs reported having a year-end ambulatory handoff system, and 4% reported assessing residents for competency in this area. The top three barriers to developing a year-end handoff system were insufficient overlap between graduating and incoming residents, inability to schedule patients with new residents in advance, and time constraints for residents, attendings, and support staff. Most internal medicine programs do not have a year-end clinic handoff system in place. Greater attention to clinic handoffs and resident assessment of this care transition is needed.

The Medicinal Cannabis Treatment Agreement: Providing Information to Chronic Pain Patients Through a Written Document.

PubMed

Wilsey, Barth; Atkinson, J Hampton; Marcotte, Thomas D; Grant, Igor

2015-12-01

Pain practitioners would seem to have an obligation to understand and inform their patients on key issues of the evidence base on cannabinoid therapeutics. One way to fulfill this obligation might be to borrow from concepts developed in the prescription of opioids: the use of a written agreement to describe and minimize risks. Regrettably, the widespread adoption of opioids was undertaken while harmful effects were minimized; obviously, no one wants to repeat this misstep. This article describes a method of educating patients in a manner analogous to other treatment agreements. Surveys have demonstrated that pain is the most common indication for medical use of cannabis. As more individuals gain access to this botanical product through state ballot initiatives and legislative mandate, the pain specialist is likely to be confronted by patients either seeking such treatment where permitted, or otherwise inquiring about its potential benefits and harms, and alternative pharmaceuticals containing cannabinoids. PubMed searches were conducted using the following keywords: cannabis guidelines, harmful effects of cannabis, medical marijuana, medicinal cannabis, opioid cannabis interaction, cannabis dependence and cannabis abuse : The authors selected individual tenets a medicinal cannabis patient would be asked to review and acknowledge via signature. Undoubtedly, the knowledge base concerning risks will be an iterative process as we learn more about the long-term use of medicinal cannabis. But we should start the process now so that patients may be instructed about our current conception of what the use of medicinal cannabis entails.

[Professor B. Jigmed's conception on the division of stages of history of Mongolian medicine].

PubMed

Wang, X H; Bao, L

2017-03-28

The division of stages on the formation and development of Mongolian medicine is a major issue on the history of Mongolian medicine. Based on Mongolian social, economic and cultural development and the characteristics of Mongolian medicine itself, Professor B. Jigmed creatively puts forward the three stages of development of ancient and modern times of Mongolian medicine. He also reasonably sorts out historical materials to comprehensively and systematically display the general picture of its development. This approach exerts great effect on restructuring the body of Mongolian medicine itself, unveils its rule of development, and promotes its disciplinary construction.

A Historical Perspective of Medical Education

ERIC Educational Resources Information Center

Balcioglu, Huseyin; Bilge, Ugur; Unluoglu, Ilhami

2015-01-01

Even though there are significant developments in recent years in medical education, physicians are still needed reform and innovation in order to prepare the information society. The spots in the forefront of medical education in recent years; holistic approach in all processes, including health education, evidence-based medicine and…

Pharmacy on demand: New technologies to enable miniaturized and mobile drug manufacturing.

PubMed

Lewin, John J; Choi, Eugene J; Ling, Geoffrey

2016-01-15

Developmental pharmaceutical manufacturing systems and techniques designed to overcome the shortcomings of traditional batch processing methods are described. Conventional pharmaceutical manufacturing processes do not adequately address the needs of military and civilian patient populations and healthcare providers. Recent advances within the Defense Advanced Research Projects Agency (DARPA) Battlefield Medicine program suggest that miniaturized, flexible platforms for end-to-end manufacturing of pharmaceuticals are possible. Advances in continuous-flow synthesis, chemistry, biological engineering, and downstream processing, coupled with online analytics, automation, and enhanced process control measures, pave the way for disruptive innovation to improve the pharmaceutical supply chain and drug manufacturing base. These new technologies, along with current and ongoing advances in regulatory science, have the future potential to (1) permit "on demand" drug manufacturing on the battlefield and in other austere environments, (2) enhance the level of preparedness for chemical, biological, radiological, and nuclear threats, (3) enhance health authorities' ability to respond to natural disasters and other catastrophic events, (4) minimize shortages of drugs, (5) address gaps in the orphan drug market, (6) support and enable the continued drive toward precision medicine, and (7) enhance access to needed medications in underserved areas across the globe. Modular platforms under development by DARPA's Battlefield Medicine program may one day improve the safety, efficiency, and timeliness of drug manufacturing. Copyright © 2016 by the American Society of Health-System Pharmacists, Inc. All rights reserved.

System Theory and Physiological Processes.

PubMed

Jones, R W

1963-05-03

Engineers and physiologists working together in experimental and theoretical studies predict that the application of system analysis to biological processes will increase understanding of these processes and broaden the base of system theory. Richard W. Jones, professor of electrical engineering at Northwestern University, Evanston, Illinois, and John S. Gray, professor of physiology at Northwestern's Medical School, discuss these developments. Their articles are adapted from addresses delivered in Chicago in November 1962 at the 15th Annual Conference on Engineering in Medicine and Biology.

Development of permissible exposure limits: the California experience.

PubMed

Cohen, Richard; Steinmaus, Craig; Quinlan, Patricia; Ku, Robert; Cooper, Michael; Roberts, Tim

2006-01-01

The California OSHA Airborne Contaminant Advisory Committee reviewed several hundred substances and recommended occupational exposure limits with the intent of worker and employer protection. The model used offers important benefits. First, by allowing open meetings, the process was transparent, and input could be offered by concerned stakeholders. Second, the process was data-driven and, therefore, less susceptible to bias and error. Third, by incorporating members with backgrounds in toxicology, epidemiology, risk assessment, occupational medicine, and industrial hygiene, the process fostered a thorough and diverse assessment of substances.

Metabolic pathways and pharmacokinetics of natural medicines with low permeability.

PubMed

Zeng, Mei; Yang, Lan; He, Dan; Li, Yao; Shi, Mingxin; Zhang, Jingqing

2017-11-01

Drug metabolism plays an important role in the drug disposal process. Differences in pharmacokinetics among individuals are the basis for personalized medicine. Natural medicines, formed by long-term evolution of nature, prioritize the action of a target protein with a drug. Natural medicines are valued for structural diversity, low toxicity, low cost, and definite biological activities. Metabolic pathway and pharmacokinetic research of natural medicines is highly beneficial for clinical dose adjustment and the development of personalized medicine. This review was performed using a systematic search of all available literature. It provides an overview and discussion of metabolic pathways and the pharmacokinetics of natural medicines with low permeability. The related enzymes and factors affecting them are analyzed. The series of metabolic reactions, including phase I reactions(oxidation hydrolysis, and reduction reactions) and phase II reactions (binding reactions), catalyzed by intracellular metabolic enzymes (such as CYP450, esterase, SULT, and UGT enzymes) in tissues (such as liver and gastro-intestinal tract) or in the body fluid environment were examined. The administration route, drug dose, and delivery system had a large influence on absorption, metabolism, and pharmacokinetics. Natural medicines with low permeability had distinctive metabolisms and pharmacokinetics. The metabolic and in vivo kinetic properties were favorably modified by choosing suitable drug delivery systems, administration routes and drug doses, among other variables. This study provides valuable information for clinicians and pharmacists to guide patients safe, effective, and rational drug use. The research of metabolism and pharmacokinetics is significant in guiding personalized clinical medicine.

An ethnobotanical study of medicinal plants administered for the treatment of hypertension.

PubMed

Baharvand-Ahmadi, Babak; Bahmani, Mahmoud; Tajeddini, Pegah; Rafieian-Kopaei, Mahmoud; Naghdi, Nasrollah

2016-01-01

The incidence of cardiovascular diseases (CVDs) is very high in human societies and their prevention and treatment are the most important priority in many countries. Hypertension makes an important contribution to the development of CVDs. This study aimed to collect the ethno-medicinal knowledge of the traditional healers of Shiraz on medicinal plants used in the treatment of hypertension. Ethno-medicinal data were collected from September 2012 to July 2013 through direct interview. Twenty-five healers were interviewed using semi-structured questionnaires and their traditional ethno-medicinal knowledge was recorded. Questionnaires were included apothecary personal information, plant local name, plant parts used, method of preparation, season of harvest and traditional use. Data collected from surveys and interviews were transferred to Microsoft Excel 2007 and analyzed. Analysis of data showed that, 27 medicinal plants from 22 families are used for the treatment of hypertension. The families with most antihypertensive species were Apiaceae (8%), Rosaceae (8%) and Papaveraceae (8%). The most frequently used plant parts were leaves (36%) followed by fruits (30%), aerial part (17%) and branches (7%). The most frequently used preparation method was decoction (95%). Borago officinalis (51.85%), Berberis vulgaris (51.58%) had the highest frequency of mention. The ethno-medicinal survey of medicinal plants recommended by traditional healers for the treatment of hypertension provides new areas of research on the antihypertensive effect of medicinal plants. In the case of safety and effectiveness, they can be refined and processed to produce natural drugs.

Medicine Delivery Device with Integrated Sterilization and Detection

NASA Technical Reports Server (NTRS)

Shearn, Michael J.; Greer, Harold F.; Manohara, Harish

2013-01-01

Sterile delivery devices can be created by integrating a medicine delivery instrument with surfaces that are coated with germicidal and anti-fouling material. This requires that a large-surface-area template be developed within a constrained volume to ensure good contact between the delivered medicine and the germicidal material. Both of these can be integrated using JPL-developed silicon nanotip or cryo-etch black silicon technologies with atomic layer deposition (ALD) coating of specific germicidal layers. The application of semiconductor processing techniques and technologies to the problems of fluid manipulation and delivery has enabled the integration of chemical, electrical, and mechanical manipulation of samples all within a single microfluidic device. This approach has been successfully applied at JPL to the automated processing, detection, and analysis of minute quantities (parts per trillion level) of biomaterials to develop instruments for in situ exploration or extraterrestrial bodies. The same nanofabrication techniques that are used to produce a microfluidics device are also capable of synthesizing extremely high-surface-area templates in precise locations, and coating those surfaces with conformal films to manipulate their surface properties. This methodology has been successfully applied at JPL to produce patterned and coated silicon nanotips (also known as black silicon) to manipulate the hydrophilicity of surfaces to direct the spreading of fluids in microdevices. JPL's ALD technique is an ideal method to produce the highly conformal coatings required for this type of application. Certain materials, such as TiO2, have germicidal and anti-fouling properties when they are illuminated with UV light. The proposed delivery device contacts medicine with this high-surface-area black silicon surface coated with a thin-film germicidal deposited conformally with ALD. The coating can also be illuminated with ultraviolet light for the purpose of sterilization or identification of the medicine itself. This constrained volume that is located immediately prior to delivery into a patient, ensures that the medicine delivery device is inherently sterile. An additional benefit to integrating a high-surface-area template within the fluid channel of a medicine delivery device is that one can envision a number of different functional coatings that could facilitate the capture and analysis of either microbial contaminants or the medicine itself. For example, one could attach antibodies or some other binding agent with a specific affinity to the silicon nanotip template. Once a target molecule or microbe is bound to the high-surface- area template, one could use an optical analytical technique such as fluorescence or adsorption to determine the identity and potentially the concentration of the species of interest. By illuminating the bound species from the back, it may also be possible to probe only the molecules with an evanescent wave, making detection of the species from the front side of the device much simpler.

Evolutionary history and leaf succulence as explanations for medicinal use in aloes and the global popularity of Aloe vera.

PubMed

Grace, Olwen M; Buerki, Sven; Symonds, Matthew R E; Forest, Félix; van Wyk, Abraham E; Smith, Gideon F; Klopper, Ronell R; Bjorå, Charlotte S; Neale, Sophie; Demissew, Sebsebe; Simmonds, Monique S J; Rønsted, Nina

2015-02-26

Aloe vera supports a substantial global trade yet its wild origins, and explanations for its popularity over 500 related Aloe species in one of the world's largest succulent groups, have remained uncertain. We developed an explicit phylogenetic framework to explore links between the rich traditions of medicinal use and leaf succulence in aloes. The phylogenetic hypothesis clarifies the origins of Aloe vera to the Arabian Peninsula at the northernmost limits of the range for aloes. The genus Aloe originated in southern Africa ~16 million years ago and underwent two major radiations driven by different speciation processes, giving rise to the extraordinary diversity known today. Large, succulent leaves typical of medicinal aloes arose during the most recent diversification ~10 million years ago and are strongly correlated to the phylogeny and to the likelihood of a species being used for medicine. A significant, albeit weak, phylogenetic signal is evident in the medicinal uses of aloes, suggesting that the properties for which they are valued do not occur randomly across the branches of the phylogenetic tree. Phylogenetic investigation of plant use and leaf succulence among aloes has yielded new explanations for the extraordinary market dominance of Aloe vera. The industry preference for Aloe vera appears to be due to its proximity to important historic trade routes, and early introduction to trade and cultivation. Well-developed succulent leaf mesophyll tissue, an adaptive feature that likely contributed to the ecological success of the genus Aloe, is the main predictor for medicinal use among Aloe species, whereas evolutionary loss of succulence tends to be associated with losses of medicinal use. Phylogenetic analyses of plant use offer potential to understand patterns in the value of global plant diversity.

Strategic planning in a complex academic environment: lessons from one academic health center.

PubMed

Levinson, Wendy; Axler, Helena

2007-08-01

Leaders in academic health centers (AHCs) must create a vision for their academic unit embedded in a complex environment. A formal strategic planning process can be valuable to help shape a clear vision taking advantage of potential collaborations and to develop specific achievable long- and short-term goals. The authors describe the steps in a formal strategic planning process and illustrate it with the example of the Department of Medicine at the University of Toronto Faculty of Medicine beginning in 2004. The process included the active participation of over 300 faculty members, trainees, and stakeholders of the department and resulted in broad-based support and leadership for the resulting plan. The authors describe the steps, which include getting started, committing to planning principles, establishing the work plan, understanding the environment, pulling it all together, shaping the vision, testing strategic directions, building effective implementation, and promoting the plan. Articulation of vision, mission, and values informed the plan's development, as well as 10 key principles integral to the plan. Challenges and lessons learned are also described. The final strategic plan is an active core activity of the department, guiding decisions and resource allocation and facilitating measurement of success or shortcomings. The process the authors describe is applicable to multiple academic units, including divisions/sections, departments, or thematic programs in AHCs.

Botanical drugs in Ayurveda and Traditional Chinese Medicine.

PubMed

Jaiswal, Yogini; Liang, Zhitao; Zhao, Zhongzhen

2016-12-24

China and India have a long history in the therapeutic application of botanical drugs in traditional medicine. Traditional Chinese Medicine (TCM) and Ayurveda are considered as two of the most ancient systems of medicine, with history of more than two millennia. Medicinal plants are the principal medicinal materials used in both these systems. This review discusses about the histories of Ayurveda and TCM, the common medicinal plants species, the drug processing strategies used, and the current statuses of these traditional systems of medicine (TSM). Through the views presented in this article, we aim to provide a new perspective to herbal drug researchers for expanding and improving the utilization of botanical drugs and their therapeutic applications. A bibliographic investigation of Chinese and Indian pharmacopoeias, monographs and official websites was performed. Furthermore, information was obtained from scientific databases on ethnobotany and ethno medicines. The review of Ayurveda and TCM ethno medicine indicates that both these systems have many medicinal materials in common. The studies carried out by the authors for comparison of plants from same genus from both these TSM's have been discussed to further bring focus to the utilization of "qualitatively" similar species which can be utilized and substituted for endangered or economically valued species. The overview of ancient literature and scientific findings for drugs in both these systems suggests that, the botanical drugs used in common and their processing methods can be explored further for extensive utilization in traditional medicine. This review describes the histories, common medicinal plant species, their processing methods and therapeutic applications in Ayurveda and TCM. The insights provided through this article may be used by herbal drug researchers and pharmacologists for further exploration of botanical drugs from these two traditional systems of medicine. Copyright © 2016. Published by Elsevier Ireland Ltd.

Cooperative knowledge evolution: a construction-integration approach to knowledge discovery in medicine.

PubMed

Schmalhofer, F J; Tschaitschian, B

1998-11-01

In this paper, we perform a cognitive analysis of knowledge discovery processes. As a result of this analysis, the construction-integration theory is proposed as a general framework for developing cooperative knowledge evolution systems. We thus suggest that for the acquisition of new domain knowledge in medicine, one should first construct pluralistic views on a given topic which may contain inconsistencies as well as redundancies. Only thereafter does this knowledge become consolidated into a situation-specific circumscription and the early inconsistencies become eliminated. As a proof for the viability of such knowledge acquisition processes in medicine, we present the IDEAS system, which can be used for the intelligent documentation of adverse events in clinical studies. This system provides a better documentation of the side-effects of medical drugs. Thereby, knowledge evolution occurs by achieving consistent explanations in increasingly larger contexts (i.e., more cases and more pharmaceutical substrates). Finally, it is shown how prototypes, model-based approaches and cooperative knowledge evolution systems can be distinguished as different classes of knowledge-based systems.

Medication errors with electronic prescribing (eP): Two views of the same picture

PubMed Central

2010-01-01

Background Quantitative prospective methods are widely used to evaluate the impact of new technologies such as electronic prescribing (eP) on medication errors. However, they are labour-intensive and it is not always feasible to obtain pre-intervention data. Our objective was to compare the eP medication error picture obtained with retrospective quantitative and qualitative methods. Methods The study was carried out at one English district general hospital approximately two years after implementation of an integrated electronic prescribing, administration and records system. Quantitative: A structured retrospective analysis was carried out of clinical records and medication orders for 75 randomly selected patients admitted to three wards (medicine, surgery and paediatrics) six months after eP implementation. Qualitative: Eight doctors, 6 nurses, 8 pharmacy staff and 4 other staff at senior, middle and junior grades, and 19 adult patients on acute surgical and medical wards were interviewed. Staff interviews explored experiences of developing and working with the system; patient interviews focused on experiences of medicine prescribing and administration on the ward. Interview transcripts were searched systematically for accounts of medication incidents. A classification scheme was developed and applied to the errors identified in the records review. Results The two approaches produced similar pictures of the drug use process. Interviews identified types of error identified in the retrospective notes review plus two eP-specific errors which were not detected by record review. Interview data took less time to collect than record review, and provided rich data on the prescribing process, and reasons for delays or non-administration of medicines, including "once only" orders and "as required" medicines. Conclusions The qualitative approach provided more understanding of processes, and some insights into why medication errors can happen. The method is cost-effective and could be used to supplement information from anonymous error reporting schemes. PMID:20497532