A comparison of the quality of informed consent for phase I oncology trials over a 30-year period.

PURPOSE: Efforts are underway in improving the informed consent process. The success of these efforts to improve quality of informed consent forms (ICFs) for phase I oncology trials has not been previously measured. METHODS: We reviewed and compared ICFs of all phase I trials for metastatic cancer conducted between 1986 and 1999 and 2000-2015 periods at our institution. Information pertaining to ICF length, study purpose description, research regimen/methods, potential risks and benefits was extracted. The reading level was assessed by Flesch-Kincaid readability tests. RESULTS: Of 364 ICFs screened, 310 ICFs were included in this analysis. The median length of ICFs from 1986 to 1999 and 2000-2015 was 12 and 23 pages, respectively. Only 42% (1986-1999) and 57% (2000-2015) of ICFs stated that individual participants might not benefit from treatment. Only 21% (1986-1999) and 12% (2000-2015) of all ICFs were written at ≤ 8th grade reading level. The median FRE, FKGL and GFI readability scores of ICFs from 1986 to 1999 were 53.6, 8.8, and 9.5, respectively. The median FRE, FKGL, and GFI scores of studies from 2000 to 2015 were 48.5, 10.7, and 12.4, respectively. These scores indicate that the ICF text was too hard for most people to read. The mechanism of action of the treatment, study schema/calendar, possibility of experiencing unexpected risks or death, and risks to pregnant/lactating women were not reported in a substantial number of forms. CONCLUSIONS: Our results show that ICFs for phase I oncology trials over last 30 years have become longer, more difficult to read but are still lacking some important information.

The ethics of mHealth: Moving forward.

There is great power and promise for mobile health (mHealth) technology in the realms of clinical practice and research. By offering the opportunity to reshape the interaction between clinician and patient or researcher and subject, the introduction of this technology allows clinicians and researchers access to larger quantities of more timely and reliable data. The potential developments are significant, and they are ethically relevant. With all technological developments, however, come new sets of ethical risks. In this paper, I assess the ethics of mHealth. I argue that while we have an ethical obligation to advance this work in order to further the quality and scope of care, the use of mHealth technology also presents challenges that must be addressed before and during the use of this technology. After describing the ethical landscape, I offer a pragmatic approach to meeting some of these challenges and minimizing ethical risk by switching from a privacy-centered frame to a consent-centered frame.

Trends of Informed Consent forms for industry-sponsored clinical trials in rheumatology over a 17-year period: Readability, and assessment of patients' health literacy and perceptions.

OBJECTIVE: To assess trends in the length and readability of informed consent forms (ICFs) for industry-sponsored multinational clinical trials (RCTs) in rheumatology over a 17-year period. Additionally, to assess the health literacy (HL) and perceptions of ICFs among participants of current RCTs. METHODS: The readability of ICFs conducted at an outpatient rheumatology clinic between 1999 and 2016 were assessed using the INFLESZ scale. Patients' HL was assessed using SALHSA-50 and STOFHLA. Patient opinions were assessed using a self-reported, in-office questionnaire with an independent patient sample who had signed an ICF in the past 6 months. RESULTS: Thirty-nine ICFs about 22 drugs from 13 pharmaceutical companies were analyzed. The global mean readability was 57 ± 3 (95% CI: 56-58), and all ICFs were categorized as either "somewhat difficult to read" or "average." Readability remained at these levels without significant changes from 1999 to 2016. The mean length of the ICFs written between 1999 and 2005 was 13 ± 5 pages, with a significant increase thereafter (mean 22 ± 8 pages, p = 0.004). Depending on the instrument, of 95 patients participating in the HL assessment, between 18% and 44% had limited HL. Of 90 patients participating in the perceptions questionnaire, 84% reported understanding the ICF well. However, 2-57% misunderstood basic concepts, including the study drug name and placebo. CONCLUSIONS: The disparity between the readability of ICFs with patients' HL and their comprehension of ICFs continues, even after decades of attempts of regulatory agencies and numerous published suggestions.

Evolución de la digitalización del consentimiento informado en la asistencia obstétrica / Evolution of the digitization of informed consent in obstetric care

OBJETIVO: Conocer cómo está evolucionando la gestión del consentimiento informado con la implantación de nuevos desarrollos en el campo de las tecnologías de la información y comunicación, qué beneficios puede aportar a la obstetricia y en qué ámbitos. MATERIAL Y MÉTODO: Revisión narrativa de la literatura existente en las bases de datos Pubmed, Cochrane y Medes, con una estrategia de búsqueda consistente en la combinación de descriptores clave DECS y criterios de selección predefinidos. RESULTADOS: Se seleccionaron 19 referencias útiles para analizar. Se encontraron tasas de hasta el 40% de reducción del uso del papel, y la misma implicación jurídica de seguridad y confidencialidad de la firma digital con respecto a su documento homónimo firmado en papel. CONCLUSIONES: La digitalización del consentimiento informado mejora los resultados de la historia clínica digital y permite realizar gestiones más ágiles y eficientes, eliminando definitivamente el formato papel y facilitando un mejor control del usuario de sus datos de salud

OBJECTIVE: To know how informed consent management is evolving with the introduction of new developments in the field of information and communication technologies and what benefits it can bring to obstetrics and in what areas. MATERIAL AND METHOD: Narrative review of existing literature in Pubmed, Cochrane and Medes database. Search strategy consisting of a combination of key DECS descriptors and predefined selection criteria. RESULTS: Nineteen useful references for analysis were selected. We found rates of up to 40% reduction in the use of paper and the same legal, security and confidentiality implication of the digital signature with respect to its homonymous document signed on paper. CONCLUSIONS: The digitalization of informed consent improves the results of the digital medical record allowing more agile and efficient procedures, eliminating definitively the paper format and allowing a better control of the user's health data

COAST (Coordinating Options for Acute Stroke Therapy): An Advance Directive for Stroke.

BACKGROUND: Stroke is a worldwide problem with a limited number of approved treatments. Obtaining informed consent for acute stroke therapy is complicated by the breadth of information that must be communicated in a short period of time, the hectic nature of the emergency environment, the possible lack of understanding by the patient and/or family, and the critically time-sensitive nature of treatment for stroke. Complicating matters even further, patients are often unable to consent for themselves, placing the burden on surrogates to infer patients' wishes regarding treatment, and potentially limiting acute treatment by practitioners. INNOVATION: An advance directive for acute stroke therapy was created, entitled COAST (Coordinating Options for Acute Stroke Therapy). This clinical initiative is being piloted at a large comprehensive stroke center, including the development of the advance directive form, integration of the form with electronic medical records, training healthcare providers, and outreach to patients. CONCLUSIONS: COAST is an advance directive for stroke designed to make stroke care more efficient, optimize patients' autonomy, improve the quality of healthcare, and streamline the ethical management of complex care decisions in acute stroke. The inherent benefit of COAST is in providing patients and their families with more information regarding stroke and its treatment options, allowing them to take a more active role in their care.

Assessing Advance Care Planning: Examining Autonomous Selections in an Advance Directive.

We examined the management of completed advance directives including why participants completed a document, what procedures and values they chose, with whom they held end-of-life conversations, and where they stored their document. Participants elected to complete a SurveyMonkey survey that was made available to individuals who wrote an advance directive through TexasLivingWill.org; 491 individuals elected to fill out the survey, aged 19 to 94 years. The survey asked multiple questions about why participants completed an advance directive, where they would store it, and with whom they had conversations about their end-of-life wishes. A list of procedures and values allowed participants to indicate what they refused or requested in their advance directive. Advance directives are most often completed to allow patients to prepare and control the healthcare they wish to receive when dying. One-half to two-thirds of individuals refuse common end-of-life medical procedures, and the rest request the procedures. We found a correlation between the choice to refuse or request a procedure and the age of the participant. Participants reported that their end-of-life conversations most often occurred with their spouse. Respondents often reported that their advance directive was stored with their physician and power of attorney for healthcare, conversations with those individuals rarely happened. Advance directives document patients' requests for and refusals of end-of-life care. Physicians and surrogates need to be better educated so that the documents are part of a meaningful conversation with the patient. Because patients' choices change over their lifespan, these documents need to be revisited regularly and not completed as a onetime event.

Diferencias en supervivencia en pacientes con lupus eritematoso sistémico de un centro privado y uno público / Differences in survival between patients with systemic lupus erythematosus from a public and a private center

No disponible

Evaluación y mejora de la calidad de los documentos de consentimiento informado en nueve hospitales del servicio murciano de salud / Evaluation and Improvement of the Informed Consent Documents in 9 Hospitals, Spain

Fundamentos: Los documentos de consentimiento informado tienen gran importancia en el proceso de información médica. El objetivo de este trabajo fue evaluar los cambios producidos en los niveles de calidad formal de estos documentos como consecuencia de las medidas correctoras puestas en marcha tras la primera evaluación. Métodos: Ciclo completo de evaluación y mejora de la calidad con 4 evaluaciones entre los años 2007 y 2013. Se valoraron 19 criterios en 3.045 documentos pertenecientes a 9 hospitales del Servicio Murciano de Salud. En la primera evaluación se estudiaron todos los documentos y en las restantes una muestra aleatoria. A partir de los resultados de la primera evaluación se pusieron en marcha medidas correctoras. Para valorar su efectividad se calculó el porcentaje de incumplimiento de los criterios y el porcentaje de mejora relativa entre la primera y la última evaluación Para valorar la variabilidad se obtuvo la razón de variación entre hospitales en el promedio de defectos por documento. Resultados: La mejora alcanzada fue del 40,8%. Esta oscilaba entre el 94% en el nombre del centro y el 17,6% en las consecuencias relevantes, siendo las diferencias encontradas en 16 de los 19 criterios estadísticamente significativas. El promedio de defectos por documento descendió de 7,6 a 4,5 con una razón de variación entre hospitales de 8,33. Conclusiones: La mejora alcanzada en la calidad de los documentos de consentimiento informado está relacionada con la efectividad de las medidas correctoras puestas en marcha (AU)

Background: Informed consent forms are very important in the process of medical information. The aim of this study was to assess the changes in the formal quality levels of these documents, as a result of corrective measures implemented after the first evaluation. Methods: Complete cycle of evaluation and quality improvement, with 4 assessments between the years 2007 and 2013. They were assessed 19 criteria in 3,045 documents belonging to 9 hospitals of Murcian Health Service. In the first evaluation the universe was studied and in the others a random sample. From the results of the first assessment corrective measures were implemented. To evaluate its effectiveness the percentage of non-observances per criteria was obtained, calculating the percentage of relative improvement between the first and the last evaluation. To assess the variability among hospitals the high-low ratio in the average number of defects per document was obtained. Results: The percent of improvement achieved was 40.8%. This ranged from 94% in the name of the centre to 17.6% in the relevant consequences, being statistically significant in 16 of the 19 criteria. The average number of defects per document decreased from 7.6 to 4.5, with a high-low ratio among hospitals of 8.33. Conclusions: The improvement achieved in the quality of informed consent documents is related to the effectiveness of corrective measures implemented (AU)

Adding injury to injury: ethical implications of the Medicaid sterilization consent regulations.

The need for contraceptive and family planning services is often unmet, especially among lower-income women. However, the history of the provision of these services is fraught with coercion and mistrust: in 1979, in response to forced sterilization practices among doctors working with poor and minority populations, the U.S. Department of Health, Education, and Welfare imposed regulations on the informed consent process for Medicaid recipients requesting sterilization. The government mandated, among other requirements, a 30-day waiting period between consent and surgery and proscribed laboring women from providing consent. Initially intended to prevent the exploitation of poor women, these rules have instead become a barrier to many women receiving strongly desired, effective, permanent contraception. More critically, the regulations are ethically flawed: by preventing women from accessing needed family planning services, the Medicaid consent rules violate the standards of beneficence and nonmaleficence; by treating publically insured women differently from privately insured women, they fail the justice standard; and by placing constraints on women's free choice of contraceptive methods, they run afoul of the autonomy standard. The current federal sterilization consent regulations warrant revising. The new rules must simultaneously reduce barriers to tubal ligation while safeguarding the rights of women who have historically suffered mistreatment at the hands of the medical profession. These goals could best be obtained through a combined approach of improved clinician ethics education and a new standardized sterilization consent policy, which applies to all women and which abolishes the 30-day waiting period and the prohibition on obtaining consent in labor.

USign--a security enhanced electronic consent model.

Electronic consent becomes increasingly popular in the healthcare sector given the many benefits it provides. However, security concerns, e.g., how to verify the identity of a person who is remotely accessing the electronic consent system in a secure and user-friendly manner, also arise along with the popularity of electronic consent. Unfortunately, existing electronic consent systems do not pay sufficient attention to those issues. They mainly rely on conventional password based authentication to verify the identity of an electronic consent user, which is far from being sufficient given that identity theft threat is real and significant in reality. In this paper, we present a security enhanced electronic consent model called USign. USign enhances the identity protection and authentication for electronic consent systems by leveraging handwritten signatures everyone is familiar with and mobile computing technologies that are becoming ubiquitous. We developed a prototype of USign and conducted preliminary evaluation on accuracy and usability of signature verification. Our experimental results show the feasibility of the proposed model.

Respuesta de los autores. Comentarios acerca del documento de voluntades anticipadas / Author's reply. Comments on living wills

No disponible

The impact of the method of consent on response rates in the ISAAC time trends study.

BACKGROUND: Centres in Phases I and III of the International Study of Asthma and Allergies in Childhood (ISAAC) programme used the method of consent (passive or active) required by local ethics committees. METHODS: Retrospectively, relationships between achieved response rates and method of consent for 13-14 and 6-7-year-olds (adolescents and children, respectively), were examined between phases and between English and non-English language centres. RESULTS: Information was obtained for 113 of 115 centres for adolescents and 72/72 centres for children. Both age groups: most centres using passive consent achieved high response rates (>80% adolescents and >70% children). English language centres using active consent showed a larger decrease in response rate. Adolescents: seven centres changed from passive consent in Phase I to active consent in Phase III (median decrease of 13%), with five centres showing lower response rates (as low as 34%). Children: no centre changed consent method between phases. Centres using active consent had lower median response rates (lowest response rate 45%). CONCLUSION: The requirement for active consent for population school-based questionnaire studies can impact negatively on response rates, particularly English language centres, thus adversely affecting the validity of the data. Ethics committees need to consider this issue carefully.

Common consent.

The distribution of human cell lines used in research should not be hindered by restrictions from donors.