Inclusion of functional measures and frailty in the development and evaluation of medicines for older adults.

The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) E7, the guidance for the conduct of clinical trials in people older than age 65 years, dates from 1994. Since then, the inclusion of older people in clinical trials has hardly improved, particularly for the oldest old age group (individuals older than age 75 years), which is the fastest growing demographic bracket in the EU. Even though most medications are taken by this group, relevant endpoints and safety outcomes for this cohort are rarely included and reported, both in clinical trials and regulatory approval documents. To improve the critical appraisal and the regulatory review of medicines taken by frail older adults, eight recommendations are presented and discussed in this Health Policy. These recommendations are brought together from different perspectives and experience of the treatment of older patients. On one side, the perspective of medical practitioners from various clinical disciplines, with their direct experience of clinical decision making; on the other, the perspective of regulators assessing the data submitted in medicine registration dossiers, their relevance to the risk-benefit balance for older patients, and the communication of the findings in the product information. Efforts to improve the participation of older people in clinical trials have been in place for more than a decade, with little success. The recommendations presented here are relevant for stakeholders, authorities, pharmaceutical companies, and researchers alike, as the implementation of these measures is not under the capacity of a single entity. Improving the inclusion of frail older adults requires awareness, focus, and action on the part of those who can effect a much needed change.

Thinking rural health in Santal community in West Bengal: An interprofessional bottom-up approach to rural health.

BACKGROUND: An interprofessional and cross-cultural pedagogical project in community health for students in nursing, social work, anthropology and medicine at the end of the bachelor's degree begun in 2014. After a rural context fieldwork in several Santal villages of West Bengal (India), students had to conduct a research project, based on a community-health topic. AIMS: This paper describes how such a pedagogical project, introducing students to ethnographic research, can initiate new ways of thinking for possible future health interventions in rural communities. METHODS: An inductive approach based on ethnography was used during the fieldwork, including observations, interviews, focus groups and local documentation. RESULTS: Our observations led to the finding that actions in rural health cannot be initiated without: promoting an interprofessional/interdisciplinary perspective and a culture of complexity and reflectivity; considering local populations in transition and not in a fixed homogenous situation; understanding more than imposing; taking into account local disease classification and local pragmatic solutions; considering the dialogue between bio-medicine and therapeutic pluralism; considering local perceptions and practices; considering care itineraries/pathways; and finally being conscious of our apostolic function. CONCLUSION: Our interprofessional pedagogical project promotes a bottom-up approach in dialogue with a global health vision.

Design of a graphical and interactive interface for facilitating access to drug contraindications, cautions for use, interactions and adverse effects.

BACKGROUND: Drug iatrogeny is important but could be decreased if contraindications, cautions for use, drug interactions and adverse effects of drugs described in drug monographs were taken into account. However, the physician's time is limited during consultations, and this information is often not consulted. We describe here the design of "Mister VCM", a graphical interface based on the VCM graphical language, facilitating access to drug monographs. We also provide an assessment of the usability of this interface. METHODS: The "Mister VCM" interface was designed by dividing the screen into two parts: a graphical interactive one including VCM icons and synthetizing drug properties, a textual one presenting on demand drug monograph excerpts. The interface was evaluated over 11 volunteer general practitioners, trained in the use of "Mister VCM". They were asked to answer clinical questions related to fictitious randomly generated drug monographs, using a textual interface or "Mister VCM". When answering the questions, correctness of the responses and response time were recorded. RESULTS: "Mister VCM" is an interactive interface that displays VCM icons organized around an anatomical diagram of the human body with additional mental, etiological and physiological areas. Textual excerpts of the drug monograph can be displayed by clicking on the VCM icons. The interface can explicitly represent information implicit in the drug monograph, such as the absence of a given contraindication. Physicians made fewer errors with "Mister VCM" than with text (factor of 1.7; p = 0.034) and responded to questions 2.2 times faster (p < 0.001). The time gain with "Mister VCM" was greater for long monographs and questions with implicit replies. CONCLUSION: "Mister VCM" seems to be a promising interface for accessing drug monographs. Similar interfaces could be developed for other medical domains, such as electronic patient records.

An iconic language for the graphical representation of medical concepts.

BACKGROUND: Many medication errors are encountered in drug prescriptions, which would not occur if practitioners could remember the drug properties. They can refer to drug monographs to find these properties, however drug monographs are long and tedious to read during consultation. We propose a two-step approach for facilitating access to drug monographs. The first step, presented here, is the design of a graphical language, called VCM. METHODS: The VCM graphical language was designed using a small number of graphical primitives and combinatory rules. VCM was evaluated over 11 volunteer general practitioners to assess if the language is easy to learn, to understand and to use. Evaluators were asked to register their VCM training time, to indicate the meaning of VCM icons and sentences, and to answer clinical questions related to randomly generated drug monograph-like documents, supplied in text or VCM format. RESULTS: VCM can represent the various signs, diseases, physiological states, life habits, drugs and tests described in drug monographs. Grammatical rules make it possible to generate many icons by combining a small number of primitives and reusing simple icons to build more complex ones. Icons can be organized into simple sentences to express drug recommendations. Evaluation showed that VCM was learnt in 2 to 7 hours, that physicians understood 89% of the tested VCM icons, and that they answered correctly to 94% of questions using VCM (versus 88% using text, p = 0.003) and 1.8 times faster (p < 0.001). CONCLUSION: VCM can be learnt in a few hours and appears to be easy to read. It can now be used in a second step: the design of graphical interfaces facilitating access to drug monographs. It could also be used for broader applications, including the design of interfaces for consulting other types of medical document or medical data, or, very simply, to enrich medical texts.

Ethical, pedagogical, socio-political and anthropological implications of quaternary prevention / Implicações éticas, pedagógicas, sócio-políticas e antropológicas da prevenção quaternária / Implicaciones éticas, pedagógicas, sociopolíticas y antropológicas de la prevención cuaternaria

The concept of quaternary prevention, resulting from a reflection on the doctor-patient relationship, is presented as a renewal of the age-old ethical requirement: first, a doctor must do no harm; second, the doctor must control himself/herself. The origin of the concept, its endorsement by the World Organization of Family Doctors (WONCA) and the European Union of General Practitioners (UEMO), its dissemination, and the debates to which it has given rise, are presented by a panel of authors from 10 countries. This collective text deals more specifically with: the bioethics of prevention, the importance of teaching Quaternary prevention and factual medicine, the social and political implications of the concept of quaternary prevention, and its anthropological dimensions.