Good publication practice guidelines for medical communications agencies: a MedComm perspective*

ABSTRACT

Background: Physicians and other health care personnel rely on the peer-reviewed biomedical literature as a key source for making clinical decisions. Thus, ensuring that the nonclinical and clinical findings published in biomedical journals are reported accurately and clearly, without undue influence from commercial interests, is essential. Accordingly, beginning in the mid-1990s and continuing to the present, various organizations, including the International Committee of Medical Journal Editors, the American Medical Association, the Council of Science Editors, the American Medical Writers Association, and the International Society for Medical Publication Professionals, have published guidelines to strengthen and uphold ethical standards in biomedical communications.

Scope: A task force of staff members from the AXIS group of companies reviewed these and other guidelines to assess the need for a good publication practices (GPP) document specific to medical communications agencies. As this review demonstrated an unmet need, the task force was charged with developing GPP guidelines for the AXIS group of agencies in the United States.

Findings: Although such guidelines have been previously published on behalf of medical journal editors and publishers, medical writers, academic centers, and pharmaceutical companies, there has been no prior publication in the peer-reviewed literature of good publication practices for medical communications agencies, which face unique challenges in negotiating a balance among authors, sponsoring companies, and biomedical publishers.

Conclusion: This article presents and discusses these GPP guidelines. To our knowledge, this is the first publication of guidelines developed from the perspective of a medical communications agency.     

Modelling empathy in medical and nursing education

Medical and nursing student numbers are expected to increase significantly in NZ over the next few years. The ethical, and professional and clinical skills' training of trainee health practitioners is a central and crucial component in medical and nursing education and is underpinned by a strong commitment to improve patient health and well being. In this discussion we reflect on the virtue of empathy and the importance of role modelling in the education of nurses and doctors. We endorse the claim that as medical educators, how and what we teach matters.     

The rise of non-medical prescribing and medical dominance

This article contributes to the continuing debate on the professional dominance of medicine given the rising number of professions allied to medicine that now have the legal authority to prescribe and could potentially threaten this dominance. The key questions addressed are whether non-medical prescribers represent a threat to the dominance of medicine and if they do not, what has mediated doctors' response to these newer prescribers such that they are able to retain dominance? Drawing on Abbott's work on jurisdictional claims, this paper explores how the rise of non-medical prescribing has led to competing jurisdictional claims over prescribing between doctors and non-medical prescribers. This paper particularly focuses on pharmacist prescribing and how competing jurisdictional claims could be settled. It discusses why the profession of medicine is still dominant and the importance of professional ideologies to influencing the outcome of competing jurisdictional claims. The professional ideology of medicine has shifted from valuing prescribing to valuing the indeterminacy involved in complex clinical decision making, illustrating medicine's ability to adapt, retain dominance and maintain cultural authority over clinical knowledge. In contrast, pharmacist prescribers' professional ideology involves having specialist medicines expertise and being safe prescribers. Pharmacists draw upon this ideology to argue their unique competence as a prescriber: given their pharmacological knowledge and attention to detail which facilitates their role as clinical checker or ‘safety net’ on prescribing. However, medicine's cultural authority in clinical decision-making enables, when there are competing jurisdictional claims over prescribing, for doctors to retain intellectual jurisdiction: control over the cognitive knowledge base involved in prescribing and clinical decision making. Could this be eroded to a weaker form of control involving advisory jurisdiction? Should political developments further favour the widespread acceptance of prescribing as a core part of the pharmacist's role, an erosion to advisory jurisdiction may yet be possible.     

Training doctors for professionalism: some lessons from teaching clinical medical ethics

Medical professionalism encourages physicians to place their patients interests above self-interest. In recent years, many medical organizations, including the American Board of Internal Medicine (ABIM), Association of American Medical Colleges (AAMC), and the American Medical Association (AMA), have developed initiatives to strengthen medical professionalism. By emphasizing professionalism, supporters of these initiatives hope that medicine and physicians may recapture professional autonomy, decrease public criticism of medicine and physicians, and help physicians regain the moral high ground in the unending struggle with payers, both public and private. One crucial question facing medical educators is whether the concepts of professionalism can be taught to medical students and residents. This paper draws upon the author s thirty years of experience in teaching clinical medical ethics to provide guidance on how to teach the concepts of professionalism to students and residents.     

《诺亚方舟》中的圣经情结

作为西方基督教的"经书"——《圣经》,曾被许多作家不断借用到作品中。名字本身就具有象征意义的剧本《诺亚方舟》也是借用了《圣经》中的情节和人物。通过对《圣经》在《诺亚方舟》中的情节、人物的构建分析,更能全面的了解作家普拉东诺夫的创作。     

The pharmacists in the family of Maurice Genevoix

In this article, the author redraws the professional life of the pharmacists and doctors of the Genevoix family by leaning on the autobiographical recollections of the famous writer Maurice Genevoix.     

Basic medical science education must include medical informatics

Medical Informatics is the science and art of processing medical information. In this age of "Information Explosion" choosing the useful one is rather difficult, and there lies the scope of electronic database management. However, still many outstanding personnel related to the healthcare sector take pride in being "computer illiterate". The onus of the best use lies on the end-user health care providers only. Another term tele-health encompasses all the e-health and telemedicine services. Computer aided or assisted learning (CAL) is a computer based tutorial method that uses the computer to pose questions, provide remedial information and chart a student through a course. Now the emphasis in medical education, is on problem based learning (PBL) and there CAL could be of utmost help if used judiciously. Basic Medical Education and Research lays the foundation for advancing and applying proper healthcare delivery systems. There is no doubt that deep knowledge of anatomy is mandatory for successful surgery. Also, comprehensive knowledge of physiology is essential for grasping the principles of pathology and pharmacology adequately, to avoid incorrect and inadequate practice of medicine. Similarly, medical informatics is not just a subject to be learnt and forgotten after the first professional MBBS examination. The final aim of every student should not only be to become a good user but also an expert for advancing medical knowledge base through medical informatics. In view of the fast changing world of medical informatics, it is of utmost necessity to formulate a flexible syllabus rather than a rigid one.     

Effective communication of drug safety information to patients and the public: a new look.

Recent parallel developments in the fields of medicine and the social sciences are providing us with new insights and resources that have the potential for improving the effectiveness of drug safety communication and decision-making. These developments include medicine's new look at patient safety with its emphasis on complex adaptive systems, education's new appreciation for learning as an internal change process and risk communication's evolving recognition that relevant knowledge may not be the exclusive property of 'experts'. Eight principles are drawn from this analysis: there cannot be a safer drug until there is a safer system;all stakeholders are equal partners and have an equal voice in all deliberations;paternalism must be eliminated;the expertise for determining acceptable benefit and risk is dispersed throughout society;patients and all stakeholders serve as both teachers and learners;all stakeholders are involved in the identification of their learning needs, processes and evaluation of outcomes;in a complex adaptive system all individual actions are interconnected and;patients must be involved in the continuous feedback and redesign of the evolving drug safety information system. The conclusion is that we are not asking the right questions; 'what information should we communicate?' and 'how do we communicate more effectively?' should be reframed to ask 'how do we provide an equal voice for patients with the other stakeholders in the determination and communication of benefit-risk information?' Some patients are not waiting. The International Alliance of Patient Organizations (IAPO), the Database of Individual Patient Experience (Dipex) and the Self-Help Group Clearinghouse are examples of international patient driven efforts to actively participate in their own care. The author suggests that the emerging discipline of inter-active management can contribute methodologies for creating citizenship models to generate the collective wisdom and translate it into action. A future research agenda calls for creating new models of public accountability that support these evolving systems of engaging the entire community in benefit-risk determination, communication and management.     

Review article: medical, surgical and radiological management of perianal Crohn's fistulas

Aliment Pharmacol Ther 2011; 33: 5–22

Summary

Background Crohn’s anal fistulas are common and cause considerable morbidity. Their management is often difficult; medical and surgical treatments rarely lead to true healing with frequent recurrence and complications. Aim To examine medical treatments previously and currently used, surgical techniques and the important role of optimal imaging. Methods We conducted a literature search in the Pub Med database using Crohn’s, Anal Fistula, Surgery, Imaging and Medical Treatment as search terms. Results Antibiotics and immunosuppressants have a role, but slow initial response, side effects and relatively low remission rates of up to around a third with frequent recurrence limit their value. Long‐term infliximab produces clinical remission in 36–58% of patients with combined medical and surgical management achieving optimal outcomes. Traditional and newer surgical procedures often have a high rate of recurrence with a significant risk of temporary or, in up to 10% of cases, permanent stomas, incontinence and unhealed or slowly healing wounds in 30%. Conclusions Management of Crohn’s anal fistulas remains challenging. Established principles are to drain infection, use setons as required, aggressively manage active proctitis, give antibiotics, immunosuppressants and employ anti‐TNFα therapy, and they demand significant co‐operation between gastroenterologists and surgeons.     

Comparison of chemotherapy education and patient preferences in community versus academic gynecology oncology clinics.

PURPOSE: To evaluate and compare patients' preferences in receiving chemotherapy education from health care teams in community versus academic clinics. METHODS: Results from a 13-question questionnaire about the chemotherapy education preferences of patients in three community gynecology oncology clinics were compared to the results from a similar study previously conducted in an academic gynecology oncology clinic. RESULTS: A total of 57% of the 203 community-clinic respondents (116) and 67% of the 282 academic-institution respondents (189) who completed questionnaires had previously received chemotherapy. Of the patients treated in community clinics, almost 60% preferred chemotherapy education to be provided in written form and directly by a health care professional compared to 87% of the patients in academic clinics. Overall, 88% of the patients in the community clinics believed they received adequate information, compared to 63% of the patients in the academic setting. Patients in the community clinics wanted to get more in-depth answers to questions such as 'What is chemotherapy?' (54%) and 'How it is given?' (55%). In addition, community patients also wanted to know more about 'Why chemotherapy stops working?' (72%) and 'What to do and who to call about side effects?' (60%). In the academic setting, patients were less likely to want to know more about these chemotherapy related questions (42, 35, 57, and 49, respectively). CONCLUSIONS: Patients preferred to receive written chemotherapy education that was reviewed with a healthcare professional and that gave more detailed information about the chemotherapeutic drugs themselves and how to prevent and manage side effects. As a result of this questionnaire, the patient education materials used at our institution will be revised to better address patients' preferences in both treatment settings.     

美国FDA对药物临床试验的监管

文中通过对FDA的生物研究试验监查体系(bioresearch monitoring program,BIMO)开展药物临床试验监查的法律法规依据、执行检查的相关机构、检查类型、检查流程和检查结果分类进行分析研究,得出FDA对药物临床试验的监管具备完善的法律法规依据、对药物临床试验的各参与方的检查全面深入、检查队伍专业、检查标准高,以期对我国药物临床试验的监管提供借鉴,从而全面提高我国药物临床试验的监管水平。     

Scientific collaboration results in higher citation rates of published articles

STUDY OBJECTIVE: The primary objective was to analyze the relationship between the citation rate of an article and the extent of collaboration. The secondary objective was to analyze the relationship between the number of authors/article and the number of institutions/article for the period of study. METHODS: We counted the number of original research articles published in six leading journals--Cell, Science, Nature, New England Journal of Medicine, The Lancet, and Journal of the American Medical Association--for the years 1975, 1985, and 1995. For each article, we determined the number of authors and the number of separate institutions. We also determined the number of times each article that was published in 1995 was cited in future scientific articles from the Science Citation Index database. RESULTS: Science, Cell, Nature, New England Journal of Medicine, The Lancet, and Journal of the American Medical Association had 2014, 868, 3856, 643, 785, and 465 total articles published/3-year study period, respectively. There was a median of 2, 2, 2, 3, 3, and 3 institutions/article, respectively. All of the final models had a significant linear author component for which all of the parameter estimates were positive, yet variable. Thus, the number of times an article was cited correlated significantly with the number of authors and the number of institutions. CONCLUSION: A correlation exists between the number of authors and the number of times an article is cited in other articles. Investigators who are open to collaborations and those who seem to adequately manage those collaborations produce a superior product that results in a higher impact.     

Prescribing and the core curriculum for tomorrow's doctors: BPS curriculum in clinical pharmacology and prescribing for medical students

Prescribing is one of the commonest tasks expected of new doctors and is a complex process involving a mixture of knowledge, judgement and skills. Preparing graduates to be prescribers is one of the greatest challenges of modern undergraduate medical education and there is some evidence to suggest that training could be improved. The aims of this article are (i) to review some of the challenges of delivering effective prescribing education, (ii) to provide a clear statement of the learning outcomes in clinical pharmacology and prescribing that should be expected of all medical graduates and (iii) to describe a curriculum that might enable students to achieve these outcomes. We build on the previous curriculum recommendations of the British Pharmacological Society and take into account those of other key bodies, notably the General Medical Council. We have also reviewed relevant evidence from the literature and set our work in the context of recent trends in medical education. We divide our recommended learning objectives into four sections: principles of clinical pharmacology, essential drugs, essential therapeutic problems and prescribing skills. Although these will not necessarily be accepted universally we believe that they will help those who design and map undergraduate curricula to explore potential gaps and identify improvements.     

药物和医疗器械临床研究评价平台建设的思考

2018年末，国家中医药管理局在《国家中医临床研究基地业务建设方案（专家论证编写提纲）》中首次要求各个国家中医临床研究基地单位建立"药物和医疗器械的临床研究评价平台"。从该平台的职能、建设原则、目标、组织形式、工作流程、内部运行机制等方面作为切入点，结合有关政策法规及文献研究结果以及多年的临床评价工作经验，对如何建设药物和医疗器械研究评价平台，保障平台各项职能有效落实，最大化地发挥平台的作用，整合基地现有科研平台，实现资源的优化、共享等提出了可行的建议，以期为药物和医疗器械的临床评价科研平台的建设提供参考。     

Clinical pharmacology: principles and practice of drug therapy in medical education

Educational reform has taken place in many Medical Schools. A traditional passive approach has been replaced by a more active, student-centred approach, founded on Problem-Based Learning. This has not been without risk because many well-structured courses have been abandoned, and this is of particular significance to the principles and practice of drug therapy. Here we outline an approach which could be incorporated into a medical curriculum and suggest some guidelines and a list of questions that should be asked in clinical situations involving drug therapy.