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7.
BMC Med Ethics ; 20(1): 100, 2019 12 24.
Artigo em Inglês | MEDLINE | ID: mdl-31870445

RESUMO

BACKGROUND: In their paper "Research approvals iceberg: how a 'low-key' study in England needed 89 professionals to approve it and how we can do better" Petrova and Barclay highlight concerns with the health research regulatory environment in the UK. DISCUSSION: As long-standing chairs of NHS research ethics committees, researchers, and also academics in research ethics, we are also often frustrated with the regulatory process in the UK. However, we think that Petrova and Barclay's analysis is misleading because it conflates research ethics with governance and funding processes, thus failing to adequately distinguish between the national coordinating function of the Health Research Authority, local research governance processes, and interactions with research sponsors and/or the Clinical Research Network.


Assuntos
Comitês de Ética em Pesquisa , Ética em Pesquisa , Inglaterra , Humanos , Registros , Pesquisadores
8.
Psychiatr Hung ; 34(4): 393-402, 2019.
Artigo em Húngaro | MEDLINE | ID: mdl-31767799

RESUMO

This is a discussion paper on research in clinical pharmacology in the field of psychiatry. In addition to other factors the decline in discovery and development of new drugs in the field of psychiatry and the developments and growing complexity in the field of clinical trial technology, including outsourcing and risk based monitoring, reduced the number of young clinical researchers interested in this important field. The challenges posed by the restructuring within the pharmacological industry - including digitalization - should induce changes in the structure and in the processes of clinical pharmacology research and in the training of clinical research staff members. The approval of esketamine nasal spray for treatment resistant depression by the FDA and the results of research with psychedelics call for more education and training in this specific field.


Assuntos
Ensaios Clínicos como Assunto/métodos , Ensaios Clínicos como Assunto/organização & administração , Psiquiatria/educação , Pesquisadores/educação , Pesquisadores/provisão & distribução , Transtorno Depressivo Resistente a Tratamento/tratamento farmacológico , Humanos , Ketamina/administração & dosagem , Ketamina/uso terapêutico , Sprays Nasais , Serviços Terceirizados
9.
BMC Health Serv Res ; 19(1): 772, 2019 Oct 30.
Artigo em Inglês | MEDLINE | ID: mdl-31666047

RESUMO

BACKGROUND: Health care researcher-research user partnerships, referred to as integrated knowledge translation (IKT), have been adopted on an international basis, and are an effective means of co-generating and implementing evidence into policy and practice. Prior research suggests that an initiation period is essential for establishing functional partnerships. To characterize IKT initiation and describe determinants of IKT initiation success, this study explored IKT initiation processes, enablers, and barriers among researchers and research users involved in IKT partnerships. METHODS: A descriptive qualitative approach was used compliant with COREQ standards. Canadian researchers and research users in research collaborations were identified on publicly-available directories and web sites, and referred by those interviewed. They were asked to describe how partnerships were initiated, influencing factors, the length of initiation, and interventions needed to support initiation. Sampling was concurrent with data collection and analysis to achieve thematic saturation. Data were analyzed using constant comparative technique by all members of the research team. RESULTS: In total, 22 individuals from 6 provinces were interviewed (9 researchers, 11 research users, 2 connectors). They confirmed that IKT initiation is a distinct early phase of partnerships. The period ranged from 6 months to 2 years for 75.0% of participants in pre-existing partnerships, to 6 years for newly-formed partnerships. High-level themes were: Newly identifying and securing partners is an intensive process; Processes and activities take place over a protracted period through multiple interactions; Identifying and engaging committed partners is reliant on funding; and Partnership building is challenged by maintaining continuity and enthusiasm. Participants underscored the need for an IKT partner matching forum, IKT initiation toolkit, and funding for non-research activities required during IKT initiation to establish functional researcher-research user partnerships. Themes were largely similar regardless of participant years of experience with IKT or being involved in a new versus pre-existing partnership. CONCLUSIONS: IKT initiation is a recognized and important early phase of IKT that establishes functional partnerships, and once established, ongoing partnership for subsequent projects is likely. Further research is needed to develop and evaluate approaches recommended by participants for stimulating IKT initiation.


Assuntos
Pesquisadores/psicologia , Pesquisa Médica Translacional/organização & administração , Canadá , Feminino , Humanos , Masculino , Pesquisa Qualitativa , Pesquisadores/estatística & dados numéricos
13.
Pan Afr Med J ; 33: 298, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31692770

RESUMO

In Africa, training programmes as well as institutional policies on research integrity are lacking. Institutions have a responsibility to oversee research integrity through various efforts, including policies and training. We developed, implemented and evaluated an institutional approach to promote research integrity at African institutions, comprising a workshop for researchers ("bottom-up") and discussions with senior faculty on institutional policies ("top-down"). During the first day, we facilitated a workshop to introduce research integrity and promote best practices with regards to authorship, plagiarism, redundant publication and conflicts of interest. We used a variety of interactive teaching approaches to facilitate learning, including individual and group activities, small group discussions and case-based learning. We met with senior faculty on the following day to provide feedback and insights from the workshop, review current institutional policies and provide examples of what other research groups are doing. We evaluated the process. Participants actively engaged in discussions, recognised the importance of the topic and acknowledged that poor practices occurred at their institution. Discussions with senior researchers resulted in the establishment of a working group tasked with developing a publication policy for the institution. Our approach kick-started conversations on research integrity at institutions. There is a need for continued discussions, integrated training programmes and implementation of institutional policies and guidelines to promote good practices.


Assuntos
Política Organizacional , Pesquisadores/organização & administração , Pesquisa/normas , África , Autoria/normas , Humanos , Publicações/normas , Pesquisa/educação , Pesquisadores/educação
14.
Nature ; 575(7782): 257-258, 2019 11.
Artigo em Inglês | MEDLINE | ID: mdl-31723298
15.
BMJ ; 367: l5896, 2019 11 06.
Artigo em Inglês | MEDLINE | ID: mdl-31694810

RESUMO

OBJECTIVE: To assess the effect of disclosing authors' conflict of interest declarations to peer reviewers at a medical journal. DESIGN: Randomized controlled trial. SETTING: Manuscript review process at the Annals of Emergency Medicine. PARTICIPANTS: Reviewers (n=838) who reviewed manuscripts submitted between 2 June 2014 and 23 January 2018 inclusive (n=1480 manuscripts). INTERVENTION: Reviewers were randomized to either receive (treatment) or not receive (control) authors' full International Committee of Medical Journal Editors format conflict of interest disclosures before reviewing manuscripts. Reviewers rated the manuscripts as usual on eight quality ratings and were then surveyed to obtain "counterfactual scores"-that is, the scores they believed they would have given had they been assigned to the opposite arm-as well as attitudes toward conflicts of interest. MAIN OUTCOME MEASURE: Overall quality score that reviewers assigned to the manuscript on submitting their review (1 to 5 scale). Secondary outcomes were scores the reviewers submitted for the seven more specific quality ratings and counterfactual scores elicited in the follow-up survey. RESULTS: Providing authors' conflict of interest disclosures did not affect reviewers' mean ratings of manuscript quality (Mcontrol=2.70 (SD 1.11) out of 5; Mtreatment=2.74 (1.13) out of 5; mean difference 0.04, 95% confidence interval -0.05 to 0.14), even for manuscripts with disclosed conflicts (Mcontrol= 2.85 (1.12) out of 5; Mtreatment=2.96 (1.16) out of 5; mean difference 0.11, -0.05 to 0.26). Similarly, no effect of the treatment was seen on any of the other seven quality ratings that the reviewers assigned. Reviewers acknowledged conflicts of interest as an important matter and believed that they could correct for them when they were disclosed. However, their counterfactual scores did not differ from actual scores (Mactual=2.69; Mcounterfactual=2.67; difference in means 0.02, 0.01 to 0.02). When conflicts were reported, a comparison of different source types (for example, government, for-profit corporation) found no difference in effect. CONCLUSIONS: Current ethical standards require disclosure of conflicts of interest for all scientific reports. As currently implemented, this practice had no effect on any quality ratings of real manuscripts being evaluated for publication by real peer reviewers.


Assuntos
Conflito de Interesses , Revelação/ética , Escrita Médica/normas , Revisão da Pesquisa por Pares/ética , Pesquisadores/ética , Adulto , Revelação/normas , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Revisão da Pesquisa por Pares/normas , Controle de Qualidade , Pesquisadores/normas
16.
Orv Hetil ; 160(43): 1706-1710, 2019 Oct.
Artigo em Húngaro | MEDLINE | ID: mdl-31630551

RESUMO

Introduction: The term "spam" is applied to unwanted commercial e-mails sent to all whose e-mail addresses have been acquired by the spammers. The number of undesirable e-mails is growing in the health-care related areas as well. The targets of health-care related spams are laymen, physicians and academic researchers alike. Method: On the basis of 12,986 unwanted letters received in one year, the authors concluded that percentage of health-related spam is the second most common spam (27%) in relation to all spam. Most of the spam (63%) aggressively promoted purchasing of various consumer goods, but health-related spam are far ahead of the rest. The collected data were grouped by year and topic and they are analyzed by simple descriptive statistics. Spam form of cyber attacks on health care issues were divided into two: spam what is jeopardized individuals' health (e.g. medical compounds without any curing effect, misleading statement on medical device, fraudulent panacea offers, and cheating cure methods, etc.) and onslaught on medical scientific activity (pseudo-scientific congress invitation, predator journal invitation etc.). Results: The topics of spams addressed to laymen are offered for perfect healing by strange treatments, cures (31%), panaceas (19%), lifestyle advice (19%), massage (16%), brand new health-care devices (4%) and drugs for sexual dysfunction (11%). The topics of spams addressed to physicians and researchers are deluged by pseudoscientific materials: invitation for articles to be sent to no-name/fake open-access journals (68%), invitation to participate at an obscure congress (27%) or newsletters on miscellanous medical topics (5%). Conclusion: The spams offer very often relief or solution to medical problems that the present-day medical practice cannot solve perfectly (oncological, musculo-sceletal, endocrin or metabolic problems). Understandably, the patients would hold on to fake hopes - and the authentic patient education and health promotion will be neglected. These unwanted messages practically cannot be unsubscribed, and - while the spam filters are far from perfection - the victim must go through the filtered spam-dustbin in order not to miss some real messages. Unfortunately no legal regulation (neither local, nor GDPR) can block or stop the spams. The spams are misleading the laymen and jeopardise the effects of professional and responsible health promotion and health education. Orv Hetil. 2019; 160(43): 1706-1710.


Assuntos
Segurança Computacional , Correio Eletrônico/normas , Educação em Saúde , Internet/normas , Médicos/psicologia , Registros Eletrônicos de Saúde , Promoção da Saúde , Humanos , Pesquisadores
18.
Biochem Med (Zagreb) ; 29(3): 030711, 2019 Oct 15.
Artigo em Inglês | MEDLINE | ID: mdl-31624464

RESUMO

Introduction: It has been recommended that each laboratory modify their critical result reporting practices to reflect the clinical needs of their patient populations. The aim of this survey was to assess how well critical laboratory values defined by the Croatian Chamber of Medical Biochemists (CCMB) correspond to the needs of the physicians at University hospital "Sveti Duh" (Zagreb, Croatia). Materials and methods: We conducted a survey among physicians from five departments in our hospital. Physicians were asked general questions about critical risk results (if and how they want to be informed). A list of critical risk results defined by the CCMB was offered and physicians were asked to revise the existing critical risk results and suggest adding new parameters. Obtained data were presented as numbers. Where the number of observations was low, ratios were used. Results: Survey response rate was 43% (52/121). Majority (48/52) wants to be informed of critical risk results, either personally (31/48) or through a colleague (32/48). They prefer to be informed about critical risk results of prothrombin time, platelet count, haemoglobin, glucose, creatinine, sodium and potassium. Revisions in the CCMB critical risk result list are proposed by 13 out of 48 physicians. Neonatologists approved the CCMB's list. Conclusions: Although most critical risk results defined by the CCMB correspond well to the needs of the physicians in our hospital, some revisions are necessary to meet the particular needs of individual departments. Communication of critical risk results to those who have requested laboratory testing is highly appreciated practice.


Assuntos
Pesquisadores , Centros de Atenção Terciária , Croácia , Humanos , Médicos , Inquéritos e Questionários
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