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[PMID]:28453700
[Au] Autor:Bleiberg H; Decoster G; de Gramont A; Rougier P; Sobrero A; Benson A; Chibaudel B; Douillard JY; Eng C; Fuchs C; Fujii M; Labianca R; Larsen AK; Mitchell E; Schmoll HJ; Sprumont D; Zalcberg J
[Ad] Endereço:Institut Jules Bordet, Brussels, Belgium.
[Ti] Título:A need to simplify informed consent documents in cancer clinical trials. A position paper of the ARCAD Group.
[So] Source:Ann Oncol;28(5):922-930, 2017 05 01.
[Is] ISSN:1569-8041
[Cp] País de publicação:England
[La] Idioma:eng
[Ab] Resumo:Background: In respect of the principle of autonomy and the right of self-determination, obtaining an informed consent of potential participants before their inclusion in a study is a fundamental ethical obligation. The variations in national laws, regulations, and cultures contribute to complex informed consent documents for patients participating in clinical trials. Currently, only few ethics committees seem willing to address the complexity and the length of these documents and to request investigators and sponsors to revise them in a way to make them understandable for potential participants. The purpose of this work is to focus on the written information in the informed consent documentation for drug development clinical trials and suggests (i) to distinguish between necessary and not essential information, (ii) to define the optimal format allowing the best legibility of those documents. Methods: The Aide et Recherche en Cancérologie Digestive (ARCAD) Group, an international scientific committee involving oncologists from all over the world, addressed these issues and developed and uniformly accepted a simplified informed consent documentation for future clinical research. Results: A simplified form of informed consent with the leading part of 1200-1800 words containing all of the key information necessary to meet ethical and regulatory requirements and 'relevant supportive information appendix' of 2000-3000 words is provided. Conclusions: This position paper, on the basis of the ARCAD Group experts discussions, proposes our informed consent model and the rationale for its content.
[Mh] Termos MeSH primário: Termos de Consentimento
Neoplasias/tratamento farmacológico
[Mh] Termos MeSH secundário: Ensaios Clínicos como Assunto
Conhecimentos, Atitudes e Prática em Saúde
Seres Humanos
Consentimento Livre e Esclarecido
Participação do Paciente
Guias de Prática Clínica como Assunto
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Em] Mês de entrada:1803
[Cu] Atualização por classe:180308
[Lr] Data última revisão:
180308
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:170429
[St] Status:MEDLINE
[do] DOI:10.1093/annonc/mdx050


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[PMID]:28453709
[Au] Autor:Remon J; Ferté C
[Ad] Endereço:Department of Oncology, Hospital Vall d'Hebron, Barcelona, Spain.
[Ti] Título:A step towards the harmonization of clinical trials inform consent forms.
[So] Source:Ann Oncol;28(5):910-912, 2017 05 01.
[Is] ISSN:1569-8041
[Cp] País de publicação:England
[La] Idioma:eng
[Mh] Termos MeSH primário: Termos de Consentimento
Consentimento Livre e Esclarecido
[Mh] Termos MeSH secundário: Ensaios Clínicos como Assunto
Seres Humanos
[Pt] Tipo de publicação:EDITORIAL; COMMENT
[Em] Mês de entrada:1801
[Cu] Atualização por classe:180118
[Lr] Data última revisão:
180118
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:170429
[St] Status:MEDLINE
[do] DOI:10.1093/annonc/mdx082


  3 / 1456 MEDLINE  
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[PMID]:28986425
[Au] Autor:Haussen DC; Doppelheuer S; Schindler K; Grossberg JA; Bouslama M; Schultz M; Perez H; Hall A; Frankel M; Nogueira RG
[Ad] Endereço:From the Grady Memorial Hospital, Emory University, Atlanta, GA.
[Ti] Título:Utilization of a Smartphone Platform for Electronic Informed Consent in Acute Stroke Trials.
[So] Source:Stroke;48(11):3156-3160, 2017 Nov.
[Is] ISSN:1524-4628
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:BACKGROUND AND PURPOSE: The informed consent process is a major limitation for enrollment in acute stroke clinical investigations. We aim to describe the novel application of smartphone electronic informed consenting (e-Consent) in trials of cerebral thrombectomy. METHODS: The e-Consent tool consists of a secure/Health Insurance Portability and Accountability Act compliant smartphone platform based on REDCap (Research Electronic Data Capture; Vanderbilt University, TN) that uses a survey project located on a static webpage. A link to the webpage is sent via text message or email to the legally authorized representative. The e-Consent form is filled and a freehand electronic signature added in the smartphone browser; a record ID and an e-Consent Process Attestation form are automatically generated. The e-Consent application was piloted in a randomized trial comparing endovascular versus medical therapy in late presenting patients (DAWN [Clinical Mismatch in the Triage of Wake Up and Late Presenting Strokes Undergoing Neurointervention With Trevo]). Trial enrollment began in January 2015; e-Consent was approved by the local institutional review board in December 2016, and the study was stopped in February 2017. RESULTS: During the trial period, Grady Memorial Hospital performed 273 thrombectomies with 47 patients being consented and 38 patients enrolled in the DAWN trial. Of the randomized patients, 29 (76%) were transferred from outside hospitals. A total of 6 surrogates were e-Consented, with 2 patients being screen failures. Enrolled e-Consented patients (n=4) had similar age (73±14 versus 69±12 years; =0.65) and National Institutes of Health Stroke Scale (16±5 versus 16±5; =0.88) as compared with conventionally consented (n=25). Time from door-to-randomization was decreased with e-Consenting (28±9 versus 57±24 minutes; =0.002). CONCLUSIONS: e-Consenting streamlined the consenting process in a randomized trial of patients with emergent large vessel occlusion strokes.
[Mh] Termos MeSH primário: Termos de Consentimento
Registros Eletrônicos de Saúde
Internet
Smartphone
Acidente Vascular Cerebral/cirurgia
Trombectomia
Navegador
[Mh] Termos MeSH secundário: Doença Aguda
Idoso
Idoso de 80 Anos ou mais
Feminino
Seres Humanos
Masculino
Meia-Idade
[Pt] Tipo de publicação:JOURNAL ARTICLE; RANDOMIZED CONTROLLED TRIAL
[Em] Mês de entrada:1710
[Cu] Atualização por classe:171026
[Lr] Data última revisão:
171026
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:171008
[St] Status:MEDLINE
[do] DOI:10.1161/STROKEAHA.117.018380


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[PMID]:28829766
[Au] Autor:Forster AS; Cornelius V; Rockliffe L; Marlow LA; Bedford H; Waller J
[Ad] Endereço:Research Department of Behavioural Science and Health, UCL, Gower Street, London WC1E 6BT, UK.
[Ti] Título:A cluster randomised feasibility study of an adolescent incentive intervention to increase uptake of HPV vaccination.
[So] Source:Br J Cancer;117(8):1121-1127, 2017 Oct 10.
[Is] ISSN:1532-1827
[Cp] País de publicação:England
[La] Idioma:eng
[Ab] Resumo:BACKGROUND: Uptake of human papillomavirus (HPV) vaccination is suboptimal among some groups. We aimed to determine the feasibility of undertaking a cluster randomised controlled trial (RCT) of incentives to improve HPV vaccination uptake by increasing consent form return. METHODS: An equal-allocation, two-arm cluster RCT design was used. We invited 60 London schools to participate. Those agreeing were randomised to either a standard invitation or incentive intervention arm, in which Year 8 girls had the chance to win a £50 shopping voucher if they returned a vaccination consent form, regardless of whether consent was provided. We collected data on school and parent participation rates and questionnaire response rates. Analyses were descriptive. RESULTS: Six schools completed the trial and only 3% of parents opted out. The response rate was 70% for the girls' questionnaire and 17% for the parents'. In the intervention arm, 87% of girls returned a consent form compared with 67% in the standard invitation arm. The proportion of girls whose parents gave consent for vaccination was higher in the intervention arm (76%) than the standard invitation arm (61%). CONCLUSIONS: An RCT of an incentive intervention is feasible. The intervention may improve vaccination uptake but a fully powered RCT is needed.
[Mh] Termos MeSH primário: Termos de Consentimento
Motivação
Infecções por Papillomavirus/prevenção & controle
Vacinas contra Papillomavirus/uso terapêutico
Aceitação pelo Paciente de Cuidados de Saúde
[Mh] Termos MeSH secundário: Adolescente
Estudos de Viabilidade
Feminino
Seres Humanos
Londres
Pais
Inquéritos e Questionários
Reino Unido
[Pt] Tipo de publicação:JOURNAL ARTICLE; RANDOMIZED CONTROLLED TRIAL
[Nm] Nome de substância:
0 (Papillomavirus Vaccines)
[Em] Mês de entrada:1710
[Cu] Atualização por classe:171109
[Lr] Data última revisão:
171109
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:170823
[St] Status:MEDLINE
[do] DOI:10.1038/bjc.2017.284


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[PMID]:28828473
[Au] Autor:Doshi P; Hur P; Jones M; Albarmawi H; Jefferson T; Morgan DJ; Spears PA; Powers JH
[Ad] Endereço:University of Maryland School of Pharmacy, Pharmaceutical Health Services Research Department, Baltimore.
[Ti] Título:Informed Consent to Study Purpose in Randomized Clinical Trials of Antibiotics, 1991 Through 2011.
[So] Source:JAMA Intern Med;177(10):1-8, 2017 Oct 01.
[Is] ISSN:2168-6114
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:Importance: Potential research participants may assume that randomized trials comparing new interventions with older interventions always hypothesize greater efficacy for the new intervention, as in superiority trials. However, antibiotic trials frequently use "noninferiority" hypotheses allowing a degree of inferior efficacy deemed "clinically acceptable" compared with an older effective drug, in exchange for nonefficacy benefits (eg, decreased adverse effects). Considering these different benefit-harm trade-offs, proper informed consent necessitates supplying different information on the purposes of superiority and noninferiority trials. Objective: To determine the degree to which the study purpose is explained to potential participants in randomized clinical trials of antibiotics and the degree to which study protocols justify their selection of noninferiority hypotheses and amount of "clinically acceptable" inferiority. Design and Setting: Cross-sectional analysis of study protocols, statistical analysis plans (SAPs), and informed consent forms (ICFs) from clinical study reports submitted to the European Medicines Agency. The ICFs were read by both methodologists and patient investigators. Main Outcomes and Measures: Protocols and SAPs were used as the reference standard to determine prespecified primary hypothesis and record rationale for selection of noninferiority hypotheses and noninferiority margins. This information was cross-referenced against ICFs to determine whether ICFs explained the study purpose. Results: We obtained trial documents from 78 randomized trials with prespecified efficacy hypotheses (6 superiority, 72 noninferiority) for 17 antibiotics conducted between 1991 and 2011 that enrolled 39 407 patients. Fifty were included in the ICF analysis. All ICFs contained sections describing study purpose; however, none consistently conveyed study hypothesis to both methodologists and patient investigators. Methodologists found that 1 of 50 conveyed a study purpose. Patient investigators found that 11 of 50 conveyed a study purpose, 7 accurately and 4 inaccurately compared with the reference standard. Seventy-one of 72 noninferiority trial protocols or SAPs provided no rationale for selection of noninferiority hypothesis. None provided a clinical rationale for the chosen amount of decreased efficacy. Conclusions and Relevance: Patients were not accurately informed of study purpose, which raises questions regarding the ethics of informed consent in antibiotic trials. Noninferiority and superiority trials entail different benefit-harm trade-offs that must be conveyed for ethical informed consent.
[Mh] Termos MeSH primário: Antibacterianos/uso terapêutico
Termos de Consentimento/utilização
Consentimento Livre e Esclarecido
Ensaios Clínicos Controlados Aleatórios como Assunto/métodos
[Mh] Termos MeSH secundário: Estudos Transversais
Seres Humanos
Estudos Retrospectivos
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Nm] Nome de substância:
0 (Anti-Bacterial Agents)
[Em] Mês de entrada:1710
[Cu] Atualização por classe:171012
[Lr] Data última revisão:
171012
[Sb] Subgrupo de revista:AIM; IM
[Da] Data de entrada para processamento:170823
[St] Status:MEDLINE
[do] DOI:10.1001/jamainternmed.2017.3820


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[PMID]:28390420
[Au] Autor:Mamzer MF; Duchange N; Darquy S; Marvanne P; Rambaud C; Marsico G; Cerisey C; Scotté F; Burgun A; Badoual C; Laurent-Puig P; Hervé C
[Ad] Endereço:Laboratoire d'Ethique Médicale et Médecine Légale EA4569, Faculté de Médecine, Université Paris Descartes, 45 rue des Saints-Pères, 75006, Paris, France. marie-france.mamzer@parisdescartes.fr.
[Ti] Título:Partnering with patients in translational oncology research: ethical approach.
[So] Source:J Transl Med;15(1):74, 2017 Apr 08.
[Is] ISSN:1479-5876
[Cp] País de publicação:England
[La] Idioma:eng
[Ab] Resumo:BACKGROUND: The research program CARPEM (cancer research and personalized medicine) brings together the expertise of researchers and hospital-based oncologists to develop translational research in the context of personalized or "precision" medicine for cancer. There is recognition that patient involvement can help to take into account their needs and priorities in the development of this emerging practice but there is currently no consensus about how this can be achieved. In this study, we developed an empirical ethical research action aiming to improve patient representatives' involvement in the development of the translational research program together with health professionals. The aim is to promote common understanding and sharing of knowledge between all parties and to establish a long-term partnership integrating patient's expectations. METHODS: Two distinct committees were settled in CARPEM: an "Expert Committee", gathering healthcare and research professionals, and a "Patient Committee", gathering patients and patient representatives. A multidisciplinary team trained in medical ethics research ensured communication between the two committees as well as analysis of discussions, minutes and outputs from all stakeholders. RESULTS: The results highlight the efficiency of the transfer of knowledge between interested parties. Patient representatives and professionals were able to identify new ethical challenges and co-elaborate new procedures to gather information and consent forms for adapting to practices and recommendations developed during the process. Moreover, included patient representatives became full partners and participated in the transfer of knowledge to the public via conferences and publications. CONCLUSIONS: Empirical ethical research based on a patient-centered approach could help in establishing a fair model for coordination and support actions during cancer research, striking a balance between the regulatory framework, researcher needs and patient expectations. Our approach addresses the concept of translational ethics as a way to handle the main remaining gap between combining care and research activities in the medical pathway and the existing framework.
[Mh] Termos MeSH primário: Oncologia/ética
Pesquisa Médica Translacional/ética
[Mh] Termos MeSH secundário: Comunicação
Termos de Consentimento
Comissão de Ética
Guias como Assunto
Seres Humanos
Bases de Conhecimento
Mutação/genética
Neoplasias/genética
Medicina de Precisão
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Em] Mês de entrada:1710
[Cu] Atualização por classe:171030
[Lr] Data última revisão:
171030
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:170410
[St] Status:MEDLINE
[do] DOI:10.1186/s12967-017-1177-9


  7 / 1456 MEDLINE  
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[PMID]:28246084
[Au] Autor:Fritz Z; Slowther AM; Perkins GD
[Ad] Endereço:Warwick Medical School, Division of Health Sciences, Gibbet Hill Campus, Coventry CV4 7AL, UK.
[Ti] Título:Resuscitation policy should focus on the patient, not the decision.
[So] Source:BMJ;356:j813, 2017 02 28.
[Is] ISSN:1756-1833
[Cp] País de publicação:England
[La] Idioma:eng
[Mh] Termos MeSH primário: Reanimação Cardiopulmonar/ética
Tomada de Decisões Gerenciais
Tratamento de Emergência/ética
Ordens quanto à Conduta (Ética Médica)/ética
[Mh] Termos MeSH secundário: Reanimação Cardiopulmonar/psicologia
Reanimação Cardiopulmonar/normas
Termos de Consentimento
Tratamento de Emergência/normas
Seres Humanos
Defesa do Paciente/legislação & jurisprudência
Ressuscitação
Ordens quanto à Conduta (Ética Médica)/psicologia
Taxa de Sobrevida
Assistência Terminal/ética
Assistência Terminal/psicologia
Assistência Terminal/normas
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Em] Mês de entrada:1711
[Cu] Atualização por classe:171113
[Lr] Data última revisão:
171113
[Sb] Subgrupo de revista:AIM; IM
[Da] Data de entrada para processamento:170302
[St] Status:MEDLINE
[do] DOI:10.1136/bmj.j813


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[PMID]:28235011
[Au] Autor:Schumacher A; Sikov WM; Quesenberry MI; Safran H; Khurshid H; Mitchell KM; Olszewski AJ
[Ad] Endereço:The Brown University Oncology Research Group, Providence, Rhode Island, United States of America.
[Ti] Título:Informed consent in oncology clinical trials: A Brown University Oncology Research Group prospective cross-sectional pilot study.
[So] Source:PLoS One;12(2):e0172957, 2017.
[Is] ISSN:1932-6203
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:BACKGROUND: Informed consent forms (ICFs) for oncology clinical trials have grown increasingly longer and more complex. We evaluated objective understanding of critical components of informed consent among patients enrolling in contemporary trials of conventional or novel biologic/targeted therapies. METHODS: We evaluated ICFs for cancer clinical trials for length and readability, and patients registered on those studies were asked to complete a validated 14-question survey assessing their understanding of key characteristics of the trial. Mean scores were compared in groups defined by trial and patient characteristics. RESULTS: Fifty patients, of whom half participated in trials of immunotherapy or biologic/targeted agents and half in trials of conventional therapy, completed the survey. On average, ICFs for industry-originated trials (N = 9 trials) were significantly longer (P < .0001) and had lower Flesch ease-of-reading scores (P = .003) than investigator-initiated trials (N = 11). At least 80% of patients incorrectly responded to three key questions which addressed the experimental nature of their trial therapy, its purported efficacy and potential risks relative to alternative treatments. The mean objective understanding score was 76.9±8.8, but it was statistically significantly lower for patients who had not completed high school (P = .011). The scores did not differ significantly by type of cancer therapy (P = .12) or trial sponsor (P = .38). CONCLUSIONS: Many participants enrolled on cancer trials had poor understanding of essential elements of their trial. In order to ensure true informed consent, innovative approaches, such as expanded in-person counseling adapted to the patient's education level or cultural characteristics should be evaluated across socio-demographic groups. TRIAL REGISTRATION: Clinicaltrials.gov NCT01772511.
[Mh] Termos MeSH primário: Consentimento Livre e Esclarecido
[Mh] Termos MeSH secundário: Adulto
Idoso
Idoso de 80 Anos ou mais
Ensaios Clínicos como Assunto
Termos de Consentimento
Estudos Transversais
Feminino
Seres Humanos
Masculino
Oncologia
Meia-Idade
Projetos Piloto
Estudos Prospectivos
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Em] Mês de entrada:1708
[Cu] Atualização por classe:170821
[Lr] Data última revisão:
170821
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:170225
[St] Status:MEDLINE
[do] DOI:10.1371/journal.pone.0172957


  9 / 1456 MEDLINE  
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[PMID]:28187273
[Au] Autor:Savage N
[Ad] Endereço:Lowell, MA, USA.
[Ti] Título:Getting Data Sharing Right to Help Fulfill the Promise of Cancer Genomics.
[So] Source:Cell;168(4):551-554, 2017 Feb 09.
[Is] ISSN:1097-4172
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:Limited access to the profusion of sequence information derived from cancer patients worldwide stymies basic research and clinical decisions. Efforts are underway to streamline and safeguard data use.
[Mh] Termos MeSH primário: Acesso à Informação
Termos de Consentimento/normas
Disseminação de Informação
Neoplasias/genética
Neoplasias/terapia
[Mh] Termos MeSH secundário: Pesquisa Biomédica
Segurança Computacional
Comportamento Cooperativo
Bases de Dados Genéticas
Genômica
Seres Humanos
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Em] Mês de entrada:1705
[Cu] Atualização por classe:170523
[Lr] Data última revisão:
170523
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:170211
[St] Status:MEDLINE


  10 / 1456 MEDLINE  
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[PMID]:28146568
[Au] Autor:Villafranca A; Kereliuk S; Hamlin C; Johnson A; Jacobsohn E
[Ad] Endereço:University of Manitoba, Department of Anesthesiology and Perioperative Medicine, CR31-42 369 Tache Ave, Winnipeg, MB, Canada.
[Ti] Título:The Appropriateness of Language Found in Research Consent Form Templates: A Computational Linguistic Analysis.
[So] Source:PLoS One;12(2):e0169143, 2017.
[Is] ISSN:1932-6203
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:BACKGROUND: To facilitate informed consent, consent forms should use language below the grade eight level. Research Ethics Boards (REBs) provide consent form templates to facilitate this goal. Templates with inappropriate language could promote consent forms that participants find difficult to understand. However, a linguistic analysis of templates is lacking. METHODS: We reviewed the websites of 124 REBs for their templates. These included English language medical school REBs in Australia/New Zealand (n = 23), Canada (n = 14), South Africa (n = 8), the United Kingdom (n = 34), and a geographically-stratified sample from the United States (n = 45). Template language was analyzed using Coh-Metrix linguistic software (v.3.0, Memphis, USA). We evaluated the proportion of REBs with five key linguistic outcomes at or below grade eight. Additionally, we compared quantitative readability to the REBs' own readability standards. To determine if the template's country of origin or the presence of a local REB readability standard influenced the linguistic variables, we used a MANOVA model. RESULTS: Of the REBs who provided templates, 0/94 (0%, 95% CI = 0-3.9%) provided templates with all linguistic variables at or below the grade eight level. Relaxing the standard to a grade 12 level did not increase this proportion. Further, only 2/22 (9.1%, 95% CI = 2.5-27.8) REBs met their own readability standard. The country of origin (DF = 20, 177.5, F = 1.97, p = 0.01), but not the presence of an REB-specific standard (DF = 5, 84, F = 0.73, p = 0.60), influenced the linguistic variables. CONCLUSIONS: Inappropriate language in templates is an international problem. Templates use words that are long, abstract, and unfamiliar. This could undermine the validity of participant informed consent. REBs should set a policy of screening templates with linguistic software.
[Mh] Termos MeSH primário: Termos de Consentimento
Ética em Pesquisa
Linguagem
Pesquisa
[Mh] Termos MeSH secundário: Compreensão
Simulação por Computador
Termos de Consentimento/normas
Seres Humanos
Linguística
Modelos Teóricos
Pesquisa/normas
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Em] Mês de entrada:1708
[Cu] Atualização por classe:170808
[Lr] Data última revisão:
170808
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:170202
[St] Status:MEDLINE
[do] DOI:10.1371/journal.pone.0169143



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