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3.
Lancet ; 395(10221): 361-369, 2020 02 01.
Artículo en Inglés | MEDLINE | ID: mdl-31958402

RESUMEN

BACKGROUND: Failure to report the results of a clinical trial can distort the evidence base for clinical practice, breaches researchers' ethical obligations to participants, and represents an important source of research waste. The Food and Drug Administration Amendments Act (FDAAA) of 2007 now requires sponsors of applicable trials to report their results directly onto ClinicalTrials.gov within 1 year of completion. The first trials covered by the Final Rule of this act became due to report results in January, 2018. In this cohort study, we set out to assess compliance. METHODS: We downloaded data for all registered trials on ClinicalTrials.gov each month from March, 2018, to September, 2019. All cross-sectional analyses in this manuscript were performed on data extracted from ClinicalTrials.gov on Sept 16, 2019; monthly trends analysis used archived data closest to the 15th day of each month from March, 2018, to September, 2019. Our study cohort included all applicable trials due to report results under FDAAA. We excluded all non-applicable trials, those not yet due to report, and those given a certificate allowing for delayed reporting. A trial was considered reported if results had been submitted and were either publicly available, or undergoing quality control review at ClinicalTrials.gov. A trial was considered compliant if these results were submitted within 1 year of the primary completion date, as required by the legislation. We described compliance with the FDAAA 2007 Final Rule, assessed trial characteristics associated with results reporting using logistic regression models, described sponsor-level reporting, examined trends in reporting, and described time-to-report using the Kaplan-Meier method. FINDINGS: 4209 trials were due to report results; 1722 (40·9%; 95% CI 39·4-42·2) did so within the 1-year deadline. 2686 (63·8%; 62·4-65·3) trials had results submitted at any time. Compliance has not improved since July, 2018. Industry sponsors were significantly more likely to be compliant than non-industry, non-US Government sponsors (odds ratio [OR] 3·08 [95% CI 2·52-3·77]), and sponsors running large numbers of trials were significantly more likely to be compliant than smaller sponsors (OR 11·84 [9·36-14·99]). The median delay from primary completion date to submission date was 424 days (95% CI 412-435), 59 days higher than the legal reporting requirement of 1 year. INTERPRETATION: Compliance with the FDAAA 2007 is poor, and not improving. To our knowledge, this is the first study to fully assess compliance with the Final Rule of the FDAAA 2007. Poor compliance is likely to reflect lack of enforcement by regulators. Effective enforcement and action from sponsors is needed; until then, open public audit of compliance for each individual sponsor may help. We will maintain updated compliance data for each individual sponsor and trial at fdaaa.trialstracker.net. FUNDING: Laura and John Arnold Foundation.


Asunto(s)
Ensayos Clínicos como Asunto/legislación & jurisprudencia , Conducta Cooperativa , Informe de Investigación/legislación & jurisprudencia , Investigación Biomédica/legislación & jurisprudencia , Ensayos Clínicos como Asunto/normas , Ensayos Clínicos como Asunto/estadística & datos numéricos , Estudios de Cohortes , Revelación/legislación & jurisprudencia , Revelación/normas , Revelación/estadística & datos numéricos , Humanos , Sistema de Registros , Informe de Investigación/normas , Estados Unidos , United States Food and Drug Administration
6.
Forensic Sci Int ; 306: 110069, 2020 Jan.
Artículo en Inglés | MEDLINE | ID: mdl-31830618

RESUMEN

Veterinary forensics is rapidly emerging as a distinct branch of veterinary medicine, especially because of increasing mindfulness about animal cruelty, and of the link between acts of cruelty to animals and violence toward humans. Nevertheless, the application of forensic sciences in veterinary cases lags behind its application in medical cases. Although gaps persist in veterinarians' knowledge of forensics and in how to apply this field to medicolegal cases involving animals, continued research and publication in veterinary forensics are rapidly developing the evidence base in this area. Additionally, educational opportunities in veterinary forensics are also increasing at both undergraduate and postgraduate levels. Together, these changes will continue to improve veterinarians' abilities to investigate cases involving animals. To further strengthen these investigations, veterinarians should also collaborate with the appropriate experts in different disciplines of forensic science.


Asunto(s)
Medicina Legal , Medicina Veterinaria , Bienestar del Animal , Animales , Animales Salvajes , Conservación de los Recursos Naturales , Conducta Cooperativa , Crimen , Especies en Peligro de Extinción , Medicina Basada en la Evidencia , Humanos , Edición , Veterinarios
7.
Disasters ; 44(1): 25-43, 2020 Jan.
Artículo en Inglés | MEDLINE | ID: mdl-31231841

RESUMEN

Although the literature is increasingly concerned with cooperation among humanitarian non-governmental organisations (NGOs), we still lack studies that explain cooperation under conditions of competition. Drawing on 22 semi-structured interviews, this article argues that trust is the driving force behind security-related cooperation within networks of humanitarian NGOs. Which type of trust comes into play and how trust is built depends on the structure of a network. In small, stable networks, trust is typically based on experience, whereas shared identity is at the heart of trust in large, unstable networks. In the latter case, cooperation among humanitarian NGOs is exclusive and comparable to a form of club governance, because NGOs are kept out based on their identity-that is, if they adopt a different operational interpretation of the humanitarian principles.


Asunto(s)
Conducta Cooperativa , Organizaciones/organización & administración , Sistemas de Socorro/organización & administración , Medidas de Seguridad/organización & administración , Confianza/psicología , Humanos
8.
Ann R Coll Surg Engl ; 102(1): 3-8, 2020 Jan.
Artículo en Inglés | MEDLINE | ID: mdl-31858833

RESUMEN

INTRODUCTION: Achieving a standard of clinical research at the pinnacle of the evidence pyramid is historically expensive and logistically challenging. Research collaboratives have delivered high-impact prospective multicentre audits and clinical trials by using trainee networks with a range of enabling technology. This review outlines such use of technology in the UK and provides a framework of recommended technologies for future studies. METHODS: A review of the literature identified technology used in collaborative projects. Additional technologies were identified through web searches. Technologies were grouped into themes including access (networking and engagement), collaboration and event organisation. The technologies available to support each theme were studied further to outline relative benefits and limitations. FINDINGS: Thirty-three articles from trainee research collaboratives were identified. The most frequently documented technologies were social media applications, website platforms and research databases. The Supportive Technologies in Collaborative Research framework is proposed, providing a structure for using the technologies available to support multicentre collaboration. Such technologies are often overlooked in the literature by established and start-up collaborative project groups. If used correctly, they might help to overcome the physical, logistical and financial barriers of multicentre clinical trials.


Asunto(s)
Investigación Biomédica/métodos , Tecnología Biomédica/métodos , Conducta Cooperativa , Relaciones Interprofesionales , Ensayos Clínicos como Asunto , Comunicación , Cirugía General/educación , Humanos , Internet , Redes Sociales en Línea , Estudiantes de Medicina
12.
Rev Assoc Med Bras (1992) ; 65(10): 1241-1248, 2019.
Artículo en Inglés | MEDLINE | ID: mdl-31721955

RESUMEN

OBJECTIVES: To investigate how many Brazilian medical and physical therapy schools have initiatives and courses related to IPE in their curricula, assessing the barriers and factors associated with their implementation and comparing the differences between both programs. METHODS: This nationwide survey was carried out in 2017 and included representatives of all physical therapy and medical schools in Brasil. Offers of interprofessional activities and related opinions and barriers were evaluated. RESULTS: A total of 76 (33.9%) of the medical and 159 (41.4%) of the physical therapy schools answered the questionnaires. At least 68.4% of the medical schools and 79.2% of the physical therapy schools have IPE initiatives, although the number of mandatory courses and clerkships is still low. Despite recognizing IPE's importance in health education, school representatives see the lack of integration of programs, conflicting schedules, and the lack of institutional support as barriers. In physical therapy, there is a smaller perception of barriers and greater incorporation of mandatory programs in the curriculum. CONCLUSION: These results will help in the development of future interventions that can enhance IPE in curricula in developing countries.


Asunto(s)
Educación de Postgrado en Medicina/métodos , Relaciones Interprofesionales , Facultades de Medicina/estadística & datos numéricos , Brasil , Conducta Cooperativa , Curriculum , Humanos , Medicina , Modalidades de Fisioterapia , Encuestas y Cuestionarios
13.
Pan Afr Med J ; 33: 313, 2019.
Artículo en Inglés | MEDLINE | ID: mdl-31692862

RESUMEN

The role of a Medical Science Liaison (MSL) is of growing importance to pharmaceutical, biotechnology, diagnostic and medical device companies. Through scientific engagement MSLs add value to clinical practice, ultimately benefiting patients. The MSL role is dynamic and encompasses in-depth product and disease knowledge together with the ability to communicate relevant, unbiased scientific information concisely and timely. Tasks are focused on contributing towards the advancement of medical knowledge, scientific data generation and dissemination. Professional relationships are developed, fostering collaboration between external experts and typically the medical affairs departments of pharmaceutical companies through a credible liaison. Through such relationships, critical insights are shared that shape the development pipeline, promote successful clinical translation and guide the market deployment strategy of therapeutic interventions through-out their life cycle. Despite the rising number of MSLs in the field and the implicit medical value of the role, there remains a lack of understanding for what the roles of a MSL entails. In Africa, where exponential growth of the pharmaceutical industry is expected, the number of MSLs will increase rapidly. Given the complexities of the African continent, the MSLs in this burgeoning environment will face various challenges including remote locations, time-constraints, regulatory and bureaucratic hurdles and importantly physician misperception of the MSL role that collectively may thwart the goal of meaningful scientific engagement; but these challenges can be surmounted through astute proactive planning and utilization of opportunities including digital communication strategies.


Asunto(s)
Comunicación , Conducta Cooperativa , Industria Farmacéutica/organización & administración , África , Humanos , Industria Manufacturera/organización & administración , Rol Profesional
14.
J Emerg Manag ; 17(5): 385-401, 2019.
Artículo en Inglés | MEDLINE | ID: mdl-31736045

RESUMEN

Situated in Yogyakarta's northern region, Merapi is one of Indonesia's most active volcanoes. Surrounded by densely populated farming communities, Merapi has had 68 eruptions since 1548. Merapi's 2010 eruption was marked by bursts of ash clouds, subsidence of its top-most layer, inundation of rivers and soils by lava currents, and the alteration of its surrounding natural landscapes. Local communities depend on the natural resources on Merapi's slope for farming, livelihood, and subsistence. The eruption had sizable impacts on community lives in terms of living conditions, livelihood, and social and political structures. The dynamics of community life in response to Merapi's volcanic activities are highlighted. Using a particular focus on farming communities as the case study, the article discusses community user groups' adaptive management capacity to dynamic natural landscape frequently marked by volcanic eruptions. The discussions support local government in fostering community resilience and social cohesion in response to Merapi's activities. Empirical findings suggest that social institutions and local rules come into play and the people practice collective disaster management on behalf of the community. These social institutions take the form of neighborly ties, reciprocity, collective identity, and social and ecological responsibilities. Merapi's pasture is not free access, but dynamically governed by local and informal rules to maintain its benefits for the safety of the community.


Asunto(s)
Creación de Capacidad , Participación de la Comunidad , Conducta Cooperativa , Planificación en Desastres/métodos , Desastres , Erupciones Volcánicas/efectos adversos , Humanos , Indonesia , Resiliencia Psicológica
15.
BMC Public Health ; 19(1): 1325, 2019 Oct 22.
Artículo en Inglés | MEDLINE | ID: mdl-31640648

RESUMEN

BACKGROUND: Studies of the relationship between diverse populations, healthcare access and health outcomes have been dominated by approaches focusing on ethno-national groups or specific healthcare sectors. Healthcare bricolage conceptualises the processes by which individuals use multiple resources to address health concerns. It is relevant in superdiverse neighbourhoods with complex populations. This paper is original in its application of mixed methods to examine the extent to which, and the reasons why, individuals engage in healthcare bricolage. METHODS: The study utilized a parallel sequential methodology. Eight superdiverse neighbourhoods were selected, two in each of Bremen, Birmingham, Lisbon and Uppsala. Ethnographic research scoping the nature of each healthcare ecosystem was followed by 160 interviews (20 each neighbourhood) with a maximum variation sample of residents undertaken October 2015 to December 2016. Interviewees were asked to recall a health concern and describe actions taken to attempt resolution. Data was coded with a MAXQDA codebook checked for inter-coder reliability. Interview findings enabled identification of five types of bricolage, the nature of healthcare resources utilised and the factors which influenced residents' tactics. Results were used to design a household survey using new questions and validated epidemiological instruments implemented January to October 2017. Respondents were identified using random address files and interviewed in person or by telephone. Multinomal logistic regressions were used to estimate the effect of changing the values of determinants on the probability of observing an outcome. RESULTS: Age, gender, level of education, migration background and extent of functional limitation were associated with bricolage tactics. Individuals demonstrating high levels of agency were more likely than those with low levels to engage in bricolage. Residents with high levels of trust in physicians were less likely to bricolage than those with lower levels of trust. Levels of health literacy showed no significant effects. CONCLUSIONS: The nature and severity of health concern, trust in physicians and agency shaped residents' bricolage tactics. The concept of bricolage enabled us to make visible the actions and resources utilised around public healthcare systems that would otherwise remain outwith healthcare access research. Actions were frequently undertaken via networks offering insights into healthcare-seeking behaviour.


Asunto(s)
Centros Comunitarios de Salud/organización & administración , Accesibilidad a los Servicios de Salud/organización & administración , Disparidades en Atención de Salud/organización & administración , Características de la Residencia , Conducta Cooperativa , Ecosistema , Europa (Continente) , Femenino , Humanos , Masculino , Persona de Mediana Edad , Atención Dirigida al Paciente/organización & administración , Reproducibilidad de los Resultados
16.
Aust Vet J ; 97(11): 424-432, 2019 Nov.
Artículo en Inglés | MEDLINE | ID: mdl-31651999

RESUMEN

Extensive research in the business and organisational literature links teamwork to enhanced productivity and employee job satisfaction. Good teamwork capability is also a highly regarded graduate attribute linked to employability. This study explored desirable teamwork attributes for veterinary technology graduates in Australia, by surveying veterinarians, veterinary technology graduates, veterinary nurses, clients and academics. Respondents highlighted the importance of seven attributes sourced from the cross-disciplinary teamwork literature-'flexibility' (in approach to work), 'agreeableness', being 'cooperative', 'socially sensitive and perceptive', 'conscientiousness', being 'accepting of others' and 'sharing professional values'. The majority in each stakeholder group viewed all attributes important for teamwork concurring with findings in other fields. Few differences were found between and within groups with veterinarians and academics rating 'conscientiousness' higher than others and female clients placing more importance on relational attributes compared to male clients. Thematic analysis of an open-ended item asking the veterinary health care groups, and veterinary academics, to define teamwork generated nine themes centred on: collaboration, goals and outcomes, sharing values, relationships, diversity, communication, task-orientation, personal attributes, and workplace culture. This study illuminates an interprofessional perspective on veterinary teamwork. Results will be useful for veterinary technology, veterinary nursing and veterinary educators when developing a curriculum for interprofessional teamwork to enhance team performance, employability and, ultimately, the quality of veterinary services.


Asunto(s)
Técnicos de Animales/psicología , Conducta Cooperativa , Relaciones Interprofesionales , Cultura Organizacional , Veterinarios/psicología , Adulto , Anciano , Anciano de 80 o más Años , Australia , Estudios Transversales , Femenino , Humanos , Masculino , Persona de Mediana Edad , Grupo de Atención al Paciente , Participación de los Interesados , Encuestas y Cuestionarios , Medicina Veterinaria , Adulto Joven
17.
Nat Commun ; 10(1): 4733, 2019 10 18.
Artículo en Inglés | MEDLINE | ID: mdl-31628302

RESUMEN

It has been argued that, when they are acutely hungry, people act in self-protective ways by keeping resources to themselves rather than sharing them. In four studies, using experimental, quasi-experimental, and correlational designs (total N = 795), we examine the effects of acute hunger on prosociality in a wide variety of non-interdependent tasks (e.g. dictator game) and interdependent tasks (e.g. public goods games). While our procedures successfully increase subjective hunger and decrease blood glucose, we do not find significant effects of hunger on prosociality. This is true for both decisions incentivized with money and with food. Meta-analysis across all tasks reveals a very small effect of hunger on prosociality in non-interdependent tasks (d = 0.108), and a non-significant effect in interdependent tasks (d = -0.076). In study five (N = 197), we show that, in stark contrast to our empirical findings, people hold strong lay theories that hunger undermines prosociality.


Asunto(s)
Técnicas de Observación Conductual/métodos , Hambre/fisiología , Conducta Social , Bienestar Social/psicología , Glucemia/metabolismo , Conducta de Elección/fisiología , Conducta Cooperativa , Femenino , Juegos Experimentales , Humanos , Masculino , Motivación/fisiología , Distribución Aleatoria , Recompensa , Adulto Joven
18.
Rev Med Suisse ; 15(669): 1962-1966, 2019 Oct 30.
Artículo en Francés | MEDLINE | ID: mdl-31663695

RESUMEN

In ambulatory care, the community pharmacist and the general practitioner most often interact through the dispensing of medicines in pharmacies following a prescription from the physician. However, this interaction can be reinforced by other practices that can increase the quality and safety of care. Interprofessional collaboration is possible through the development of increasing interrelationships, particularly in the sharing of information through dialogue on common objectives that integrate the perspectives of patients and professionals, and through joint decision-making. In this article, interprofessional collaboration between pharmacists and general practitioners is described, as well as data from the literature and some concrete examples from the regular practice of pharmacists and physicians in Unisanté.


Asunto(s)
Atención Ambulatoria/organización & administración , Conducta Cooperativa , Relaciones Interprofesionales , Farmacéuticos , Médicos , Humanos , Seguridad del Paciente
19.
20.
Health Serv Res ; 54(6): 1246-1254, 2019 12.
Artículo en Inglés | MEDLINE | ID: mdl-31595498

RESUMEN

OBJECTIVE: To measure strategies of interorganizational collaboration among health care and social service organizations that serve older adults. STUDY SETTING: Twenty Hospital Service Areas (HSAs) in the United States. STUDY DESIGN: We developed and validated a novel scale to characterize interorganizational collaboration, and then tested its application by assessing whether the scale differentiated between HSAs with high vs low performance on potentially avoidable health care use and spending for Medicare beneficiaries. DATA COLLECTION: Health care and social service organizations (N = 173 total) in each HSA completed a 12-item collaboration scale, three questions about collaboration behaviors, and a detailed survey documenting collaborative network ties. PRINCIPAL FINDINGS: We identified two distinguishable subscales of interorganizational collaboration: (a) Aligning Strategy and (b) Coordinating Current Work. Each subscale demonstrated convergent validity with the organization's position in the collaborative network, and with collaboration behaviors. The full scale and Coordinating Current Work subscale did not differentiate high- vs low-performing HSAs, but the Aligning Strategy subscale was significantly higher in high-performing HSAs than in low-performing HSAs (P = .01). CONCLUSIONS: Cross-sector collaboration-and particularly Aligning Strategy-is associated with health care use and spending for older adults. This new survey measure could be used to track the impact of interventions to foster interorganizational collaboration.


Asunto(s)
Conducta Cooperativa , Relaciones Interinstitucionales , Medicare/organización & administración , Reproducibilidad de los Resultados , Servicio Social/organización & administración , Encuestas y Cuestionarios/normas , Adulto , Anciano , Anciano de 80 o más Años , Femenino , Humanos , Masculino , Medicare/estadística & datos numéricos , Persona de Mediana Edad , Servicio Social/estadística & datos numéricos , Estados Unidos
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