Developing a simplified consent form for biobanking.

BACKGROUND: Consent forms have lengthened over time and become harder for participants to understand. We sought to demonstrate the feasibility of creating a simplified consent form for biobanking that comprises the minimum information necessary to meet ethical and regulatory requirements. We then gathered preliminary data concerning its content from hypothetical biobank participants. METHODOLOGY/PRINCIPAL FINDINGS: We followed basic principles of plain-language writing and incorporated into a 2-page form (not including the signature page) those elements of information required by federal regulations and recommended by best practice guidelines for biobanking. We then recruited diabetes patients from community-based practices and randomized half (n = 56) to read the 2-page form, first on paper and then a second time on a tablet computer. Participants were encouraged to use "More information" buttons on the electronic version whenever they had questions or desired further information. These buttons led to a series of "Frequently Asked Questions" (FAQs) that contained additional detailed information. Participants were asked to identify specific sentences in the FAQs they thought would be important if they were considering taking part in a biorepository. On average, participants identified 7 FAQ sentences as important (mean 6.6, SD 14.7, range: 0-71). No one sentence was highlighted by a majority of participants; further, 34 (60.7%) participants did not highlight any FAQ sentences. CONCLUSIONS: Our preliminary findings suggest that our 2-page form contains the information that most prospective participants identify as important. Combining simplified forms with supplemental material for those participants who desire more information could help minimize consent form length and complexity, allowing the most substantively material information to be better highlighted and enabling potential participants to read the form and ask questions more effectively.

The role of coronial autopsies in a context of decreasing hospital autopsies: An investigation of the issues

This article scrutinises the argument that decreasing hospital autopsy rates are outside the control of medical personnel, based as they are on families’ unwillingness to consent to autopsy procedures, and that, as a consequence, the coronial autopsy is the appropriate alternative to the important medical and educational role of the autopsy. It makes three points which are well supported by the research. First, that while hospital autopsy rates are decreasing, they have been doing so for more than 60 years, and issues beyond the simple notion of consent, like funding formulae in hospitals, increased technology and fear of litigation by doctors are all playing their part in this decline. Secondly, the issue of consent has as much to do with families not being approached as with families declining to give consent. This is well supported by recent changes in hospital policy and procedures which include senior medical personnel and detailed consent forms, both of which have been linked to rising consent rates in recent years. Finally, the perception that coronial autopsies are beyond familial consent has been challenged recently by legislative changes in both Australia and the United States of America which allow objections based on religion and culture to be heard by coroners. For these reasons, it is argued that medical personnel need to focus on increasing hospital autopsy rates, while also addressing the complex ethical issues associated with conducting medical research within the context of the coronial autopsy.

Evaluating emergency nurse practitioner service effectiveness on achieving timely analgesia: A pragmatic randomized controlled trial

Objectives The rapid uptake of nurse practitioner (NP) services in Australia has outpaced evaluation of this service model. A randomized controlled trial was conducted to compare the effectiveness of NP service versus standard medical care in the emergency department (ED) of a major referral hospital in Australia. Methods Patients presenting with pain were randomly assigned to receive either standard ED medical care or NP care. Primary investigators were blinded to treatment allocation for data analyses. The primary outcome measure was the proportion of patients receiving analgesia within 30 minutes from being seen by care group. Secondary outcome measures were time to analgesia from presentation and documentation of and changes in pain scores. Results There were 260 patients randomized; 128 received standard care (medical practitioner led), and 130 received NP care. Two patients needed to be excluded due to incomplete consent forms. The proportion of patients who received analgesia within 30 minutes from being seen was 49.2% (n = 64) in the NP group and 29.7% (n = 38) in the standard group, a difference of 19.5% (95% confidence interval [CI] = 7.9% to 31.2%; p = 0.001). Of 165 patients who received analgesia, 64 (84.2%) received analgesia within 30 minutes in the NP group compared to 38 (42.7%) in the standard care group, a difference in proportions of 41.5% (95% CI = 28.3% to 54.7%; p < 0.001). The mean (±SD) time from being seen to analgesia was 25.4 (±39.2) minutes for NP care and 43.0 (±35.5) minutes for standard care, a difference of 17.6 minutes (95% CI = 6.1 to 29.1 minutes; p = 0.003). There was a difference in the median change in pain score of 0.5 between care groups, but this was not statistically significant (p = 0.13). Conclusions Nurse practitioner service effectiveness was demonstrated through superior performance in achieving timely analgesia for ED patients.

Reprodutibilidade de um índice para diagnóstico e avaliação da atividade de lesões de cárie dentária na dentição decídua

O objetivo do presente estudo clínico é verificar a reprodutibilidade intra e interexaminadores de um critério de diagnóstico de cárie dentária (Nyvad et al. 1999) aplicado na dentição decídua, e avaliar o tempo médio necessário para a realização do exame clínico utilizando o referido critério. O mesmo é baseado na combinação de métodos visuais e táteis e propõe a diferenciação entre lesões ativas e inativas, tanto para lesões cavitadas quanto para não cavitadas. A amostra total consistiu de 80 crianças de três a sete anos de idade, de ambos os sexos, estudantes do Centro Educacional Terra Santa (Petrópolis/ RJ). Os responsáveis assinaram um termo de consentimento livre e esclarecido e o trabalho foi aprovado pelo Comitê de Ética em Pesquisa do HUPE-UERJ. Os exames foram realizados após escovação supervisionada, em consultório odontológico sob iluminação artificial, após 3-5s de secagem com ar comprimido, por dois examinadores treinados pelas autoras do índice e calibrados. As concordâncias intra e interexaminadores foram avaliadas pelo percentual de concordância (%) e pelo teste kappa (k), considerando a superfície dentária como unidade de análise e os seguintes pontos de corte: 1) hígida versus cariada; 2) ativa versus inativa; 3) descontinuidade versus hígida; e 4) cavitada versus hígida. O % e o valor de k para confiabilidade interexaminadores para cada ponto de corte foram: 1) % = 0,97 e k = 0,82 (IC: 0,80 - 0,85); 2) % = 0,98 e k = 0,80 (IC: 0,76 - 0,83); 3) % = 0,99 e k = 0,90 (IC: 0,88 - 0,93); 4) % = 99,0 e k = 0,95 (IC: 0,92 - 0,97). O % e o valor de k para confiabilidade intraexaminador para cada ponto de corte foram: 1) % = 0,98 e k = 0,86 (IC: 0,84 - 0,86); 2) % = 0,99 e k = 0,86 (IC: 0,83 - 0,89); 3) % = 0,99 e k = 0,94 (IC: 0,92 - 0,96); 4) % = 0,99 e k = 0,98 (IC: 0,96 - 0,99). O maior % de discordância (65,3% - 158/242) concentrou-se na diferenciação entre supefícies hígidas e lesões não cavitadas: 33,5% (81/242) entre superfície hígida e lesão não cavitada inativa; 26,0% (63/242), entre superfície hígida e lesão não cavitada ativa; e 5,8% (14/242), entre lesão não cavitada ativa e lesão não cavitada inativa. O tempo necessário para realização do exame clínico foi em média 226,5s (128,53). Conclui-se que o índice apresentou reprodutibilidade variando de substancial à quase perfeita e um tempo de exame viável, mostrando-se consistente e reproduzível para a realização de estudos clínicos de cárie dentária na dentição decídua.

Metas de socialização e práticas educativas de mães de crianças com câncer: um estudo comparativo com mães de crianças sem diagnóstico de doença

Sistemas parentais são construídos através das interações no cotidiano dos pais com seus filhos e com base nos padrões culturais vigentes, dentro de um perfil socioeconômico e da história de vida dos indivíduos. Importantes componentes dos sistemas parentais são as metas de socialização e as práticas educativas. As metas de socialização se referem a como os pais desejam que seus filhos sejam no futuro, àquilo que eles esperam que sua criação ajude a promover em seus filhos. Já as práticas educativas são as práticas de comunicar à criança a forma correta com que se espera que ela se comporte. A revisão bibliográfica evidencia que as metas de socialização e práticas educativas são afetadas pelo ambiente cultural dos cuidadores e por variáveis socioeconômicas, mas não há estudos a respeito de possíveis impactos causados por situações de vida particularmente difíceis. A presente dissertação se propôs a examinar as metas de socialização e práticas educativas de mães cujos filhos estão em tratamento oncológico, contrastando-as com as de mães de crianças saudáveis. Nesse sentido, o objetivo estabelecido foi o de investigar se havia particularidades nas metas de socialização e formas de cuidado de mães com filhos que tenham câncer devido à situação específica vivida de um tratamento oncológico. Hipotetizou-se que a vivência da experiência do câncer e a inserção em uma instituição de tratamento, no caso, o Instituto Nacional do Câncer (INCA), teriam impacto no sistema de cuidados e metas parentais. Participaram deste estudo 20 mães de crianças de três a cinco anos que estavam em tratamento oncológico no INCA e 20 mães de crianças na mesma faixa etária sem problemas de saúde diagnosticados. Todas assinaram o Termo de Consentimento Livre e Esclarecido. Foram aplicados os formulários "Dados de identificação" e "Dados sociodemográficos", e o Questionário de Metas de Socialização. Foi também realizada com as mães uma entrevista semiestruturada, com questões abertas que buscaram investigar práticas educativas. A análise de dados contemplou uma parte de análises quantitativas em que os dados foram tratados descritivamente (médias, percentuais etc.) e empregados testes não-paramétricos para comparação entre os grupos de mães. Análises qualitativas, voltadas para as respostas ao questionário de metas de socialização e à entrevista sobre práticas de cuidado educativas foram realizadas através do método de análise de conteúdo temático-categorial. Encontrou-se que as metas de socialização das mães de crianças em tratamento oncológico apresentaram diferenças em relação às das mães de crianças sem diagnóstico de doença, refletindo uma tendência mais individualista. Também foram encontradas diferenças entre os dois grupos nas ações para atingir as metas, sendo visto um uso menor da estratégia educar e orientar por parte do grupo das mães de crianças em tratamento no INCA, refletindo uma tendência mais pragmática. Quanto às práticas educativas não foram encontradas diferenças significativas entre os dois grupos. Espera-se que esse estudo traga contribuições para a formulação de programas de intervenção, para pais e cuidadores, através da melhor compreensão das metas e práticas maternas utilizadas nesta situação particular e de grande dificuldade para as crianças e suas famílias

The journey towards comprehensive school health within an aboriginal community

The purpose of this research is to describe the journey towards Comprehensive School Health at two Aboriginal elementary schools. An advocate and a healthy schools committee were identified at both schools and were responsible for developing initiatives to create a healthy school community. A case study was used to gather an in-depth understanding of Comprehensive School Health for the two schools involved. As a researcher, I functioned within the role of a participantobserver, as I was actively involved in the programs and initiatives completed in both schools. The research process included: the pilot study, ethics clearance and distribution of letters of invitation and consent forms. Data collection included 16 semi-structured, guided interviews with principals, teachers, and stupents. Participant observations included sites of the gymnasium, classroom, playgrounds, school environments, bulletin boards as well as artifact analysis of decuments such as school newsletters, physical education schedules and school handbooks. The interviews were transcribed and coded using an inductive approach which involves finding patterns, themes and categories from the data (patton, 2002). Research questions guided the findings as physical activity, physical education, nutrition and transportation were discussed. Themes developed t~rough coding were teacherstudent interactions, cultural traditions, time constraints and professional development and were discussed using a Comprehensive School Health framework.

La détermination de la juridiction compétente et de la loi applicable au contrat électronique de consommation

La détermination de la loi applicable et de la juridiction compétente en ce qui concerne les contrats électroniques internationaux constitue l’un des défis les plus importants dans l’établissement d’un cadre juridique adapté au commerce électronique. La dématérialisation des échanges et le caractère international des réseaux rendent difficile l’application des règles de droit international privé conçues pour répondre aux besoins des contrats « papier ». Dans le cas du contrat électronique de consommation, la création d’instruments juridiques adaptés devient essentielle afin de renforcer le rapport de confiance devant exister entre commerçant et cyberconsommateur et d’ainsi permettre au commerce électronique de continuer son développement. Le phénomène « Internet » lié au commerce électronique provoque, depuis un certain temps, un débat au sujet des besoins d’adaptation et de renouvellement des différentes règles étatiques et internationales portant sur les conflits de lois et de juridictions. C’est dans cette optique que cet article fait l’analyse du cadre législatif général permettant la détermination de la loi applicable et de la juridiction compétente en matière de contrat électronique international. L’article aborde également l’étude des différentes règles juridictionnelles encadrant le contrat électronique de consommation et les possibles difficultés d’application de celles-ci. Est finalement analysée la validité du consentement d’un consommateur eu égard aux clauses sur la loi applicable et le tribunal compétent imposées unilatéralement par les cybermarchands.

La reconnaissance d’autrui comme prérequis à toute forme de consentement et d’assentiment : Une réponse à Verpaelst et Touyz

Commentaire / Commentary

O consentimento informado: Qual o seu real valor na prática médica?

Trata-se de um artigo que comenta sobre a real importância do Termo de Consentimento Informado na prática médica. Este documento tem sido cada vez mais usado como uma prática defensiva, a fim de constituir provas para defesa de um eventual processo judicial de responsabilidade médica, desvirtuando assim a idéia original, que seria a de respeitar a autonomia do paciente e delimitar a responsabilidade médica. O documento tem como objetivo mostrar que o médico cumpriu com seu dever de informar. Seu grande valor reside nos casos onde existam riscos de danos irreversíveis ao paciente. Conclui-se, porém, que um prontuário bem elaborado onde se inclui o registro das informações que foram transmitidas, bem como o grau de participação dos pacientes e seus familiares nas decisões terapêuticas, também deve ter valor ético e jurídico semelhante do TCI.

O difícil enfrentamento do processo de morrer vivenciado pelo enfermeiro em unidade pediatríca

Pós-graduação em Enfermagem (mestrado profissional) - FMB

Aspectos legais e éticos na implantodontia

There are few studies that evaluate the legal aspects, consent forms and ethical considerations facing implantology. This paper reviews and discusses the most important criteria in relation to the care of patients needing dental implants. Used the following databases: Medline (Pubmed), Dentistry Oral Science , Scielo, Athenas (Dissertation / Thesis), Digital Library of UNICAMP (Dissertation / Thesis), Digital Library of USP (Dissertation / Thesis) over the past 15 years . The inclusion and exclusion criteria were clinical articles, resulting from expert opinion on the subject of review and longitudinal follow-up who have studied or reported on the ethical aspects in implant dentistry; were excluded studies whose language was not English or Portuguese. Of a total of 52 articles and theses, after an analysis according to inclusion and exclusion criteria, 26 were selected. The literature shows that the safe practice of implantology is indispensable for the success of therapy. Respect the ethical, legal and make it explicit relationship with the patient (informed consent, information) are an important factor in the success of rehabilitative treatment. Since this treatment is long term, professional dental implant requires all documentation and clarity in time to offer treatment to the patient and professional expectations are met.

Tuberculose: limites e potencialidades do tratamento supervisionado

Objetivou-se analisar potencialidades e limites da estratégia do tratamento supervisionado (DOTS) para a tuberculose, sob a percepção de usuários em tratamento e de trabalhadores de saúde de uma supervisão técnica de saúde do município de São Paulo. Entrevistaram-se 4 usuários e 17 profissionais de saúde de nove unidades básicas de saúde, entre abril e junho de 2006, após consentimento livre e esclarecido. Os depoimentos foram decodificados segundo a técnica de análise de discurso. Adotou-se a teoria da determinação social do processo saúde/doença como referencial teórico. Foram potencialidades: criação de vínculo entre profissional/usuário e incentivos ao tratamento, o que favorece a adesão. Foram limites: restrito envolvimento dos profissionais no DOTS e conciliar horário de trabalho do usuário com a supervisão. Reitera-se que a adesão ao tratamento transcende o âmbito biológico, sendo fundamental que os trabalhadores de saúde reconheçam os usuários como portadores de necessidades, não se restringindo apenas à supervisão da tomada de medicamentos.

Use of intranet and other interventions to increase influenza vaccination among health care workers

Influenza (the flu) is a serious respiratory illness that can cause severe complications, often leading to hospitalization and even death. Influenza epidemics occur in most countries every year, usually during the winter months. Despite recommendations from the Centers for Disease Control and Prevention (CDC) and efforts by health care institutions across the United States, influenza vaccination rates among health care workers in the United States remain low. How to increase the number of vaccinated health care workers is an important public health question and is examined in two journal articles included here. ^ The first journal article evaluates the effectiveness of an Intranet intervention in increasing the proportion of health care workers (HCWs) who received influenza vaccination. Hospital employees were required go to the hospital's Intranet and select "vaccine received," "contraindicated," or "declined" from the online questionnaire. Declining employees automatically received an online pop-up window with education about vaccination; managers were provided feedback on employees' participation rates via e-mail messages. Employees were reminded of the Intranet requirement in articles in the employee newsletter and on the hospital's Intranet. Reminders about the Intranet questionnaire were provided through managers and newsletters to the HCWs. Fewer than half the employees (43.7%) completed the online questionnaire. Yet the hospital witnessed a statistically significant increase in the percentage of employees who received the flu vaccine at the hospital – 48.5% in the 2008-09 season as compared to 36.5%, 38.5% and 29.8% in the previous three years (P < 0.05). ^ The second article assesses current interventions employed by hospitals, health systems and nursing homes to determine which policies have been the most effective in boosting vaccination rates among American health care workers. A systematic review of research published between January 1994 and March 2010 suggests that education is necessary but not usually sufficient to increase vaccine uptake. Education about the flu and flu vaccines is most effective when complemented with easy access and making the vaccine free, although this combination may not be sufficient to achieve the desired vaccination levels among HCWs. The findings point toward adding incentives for HCWs to get vaccinated and requiring them to record their vaccination status on a declination/consent form – either written or electronic. ^ Based on these findings, American health care organizations, such as hospitals, nursing homes, and long-term care facilities, should consider using online declination forms as a method for increasing influenza vaccination rates among their employees. These online forms should be used in conjunction with other policies, including free vaccine, mobile distribution and incentives. ^ To further spur health care organizations to adopt policies and practices that will raise influenza vaccination rates among employees, The Joint Commission – an independent, not-for- profit organization that accredits and certifies more than 17,000 health care organizations and programs in the United States – should consider altering its standards. Currently, The Joint Commission does not require signed declination forms from employees who eschew vaccination; it only echoes the CDC's recommendations: "Health care facilities should require personnel who refuse vaccination to complete a declination form." Because participation in Joint Commission accreditation is required for Medicare reimbursement, action taken by the Joint Commission to require interventions such as mandatory declination/consent forms might result in immediate action by health care organizations to follow these new standards and lead to higher vaccination rates among HCWs.^ 1“Frequently Asked Questions for H1N1 and Seasonal Influenza.” The Joint Commission - Infection Control: http://www.jointcommission.org/PatientSafety/InfectionControl/h1n1_faq.htm. ^

Clinical outcomes from skin screening clinics within a community-based melanoma screening program

Background : Within a randomized trial of population screening for melanoma, primary care physicians conducted whole-body skin examinations and referred all patients with suspect lesions to their own doctor for further treatment. Objective: Our aim was to describe characteristics of skin screening participants, clinical screening diagnoses, management following referral, and specificity and yield of screening examinations. Methods: Information collected from consent forms, referral forms, and histopathological reports of lesions that had been excised or undergone biopsy was analyzed by means of descriptive statistics. Results: A total of 16,383 whole-body skin examinations resulted in 2302 referrals (14.1% overall; 15.5% men, 18.2% >= 50 years of age) for 4129 suspect lesions (including 222 suspected melanoma, 1101 suspected basal cell carcinomas [BCCs], 265 suspected squamous cell carcinomas [SCCs]). Histopathologic results were available for 94.8% of 1417 lesions excised and confirmed 33 melanomas (23 in men; 24 in participants ? 50 years of age), 259 BCCs, and 97 SCCs. The probability of detecting skin cancer of any type within the program was 2.4%. The estimated specificity of whole-body skin examinations for melanoma was 86.1% (95% confidence interval = 85.6-86.6). The positive predictive value (number of confirmed/number of lesions excised or biopsied x 100) for melanoma was 2.5%, 19.3% for BCC, and 7.2% for SCC (overall positive predictive value for skin cancer, 28.9%). Limitations: Follow-up of participants with a negative screening examination has not been conducted for the present investigation. Conclusions: The rate of skin cancer detected per 100 patients screened was higher than previously reported and men and attendees older than 50 years more frequently received a referral and diagnosis of melanoma. The specificity for detection of melanoma through whole-body skin examination by a primary care physician was comparable to that of other screening tests, including mammography.