Implementation of a Bundled Consent Process in the ICU: A Single-Center Experience.

OBJECTIVES: A bundled consent process, where patients or surrogates provide consent for all commonly performed procedures on a single form at the time of ICU admission, has been advocated as a method for improving both rates of documented consent and patient/family satisfaction, but there has been little published literature about the use of bundled consent. We sought to determine how residents in an academic medical center with a required bundled consent process actually obtain consent and how they perceive the overall value, efficacy, and effects on families of this approach. DESIGN: Single-center survey study. SETTING: Medical ICUs in an urban academic medical center. SUBJECTS: Internal medicine residents. INTERVENTIONS: We administered an online survey about bundled consent use to all residents. Quantitative and qualitative data were analyzed. MEASUREMENTS AND MAIN RESULTS: One-hundred two of 164 internal medicine residents (62%) completed the survey. A majority of residents (55%) reported grouping procedures and discussing general risks and benefits; 11% reported conducting a complete informed consent discussion for each procedure. Respondents were divided in their perception of the value of bundled consent, but most (78%) felt it scared or stressed families. A minority (26%) felt confident that they obtained valid informed consent for critical care procedures with the use of bundled consent. An additional theme that emerged from qualitative data was concern regarding the validity of anticipatory consent. CONCLUSIONS: Resident physicians experienced with the use of bundled consent in the ICU held variable perceptions of its value but raised concerns about the effect on families and the validity of consent obtained with this strategy. Further studies are necessary to further explore what constitutes best practice for informed consent in critical care.

Aspectos médico-legales de la endoscopia digestiva. Congreso de la SEED. Zaragoza 2015 / No disponible

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¿Pero alguien entiende los consentimientos informados? Una propuesta para facilitar su comprensión / Can anybody understand the informed consent documents? A proposal to make it easier

Objetivo. Valorar la legibilidad de los documentos de consentimiento informado propuestos por los médicos analizando resultados y diferencias entre apartados del documento y servicios, con el fin de contribuir a su mejora. Material y métodos. Estudio descriptivo de los contenidos de los primeros 359 documentos remitidos por los servicios para acreditación en el Hospital Virgen de la Arrixaca (Murcia, España). Se valoró la extensión y la facilidad de comprensión. La extensión se midió en palabras (adecuado hasta 470, excesivo más de 940) y la facilidad de comprensión en puntos INFLESZ (adecuado si mayor de 55). Resultados. La extensión osciló entre 73-1.018 palabras (media 360, error típico 8,8; OR para extensión deseable 3,66, IC 95%: ±0,81). Los apartados más extensos fueron riesgos y naturaleza del procedimiento, y los menos alternativas y contraindicaciones; p < 0,0001. INFLESZ osciló entre 18,1-86,4 puntos (media 45,8, error típico 0,45), obteniendo mejor puntuación los servicios no quirúrgicos. Solo el 12,5% de los documentos alcanzaron INFLESZ superior a 55 (OR: 0,12 ± 0,03), el 70% no quirúrgicos; p < 0,0001. Los apartados de mejor comprensión fueron la naturaleza y sus riesgos, y los de peor contraindicaciones y alternativas, p < 0,0001. Conclusiones. Los documentos propuestos por los servicios tienen extensión deseable, pero no son fáciles de comprender, en especial si provienen de servicios quirúrgicos. La extensión de sus apartados no es equilibrada, siendo contraindicaciones y alternativas más cortos y difíciles de entender. Se hace indispensable comprobar y mejorar la legibilidad antes de emplear un documento. Para ello son útiles herramientas como las propuestas (AU)

Objective. To assess the readability of informed consent documents as written by doctors, by analysing the results and the differences between the sections of the document and services, with the aim of helping to improve them. Material and methods. Descriptive study of the texts from 359 documents sent for accreditation in the Arrixaca Hospital (Murcia, Spain). Both length and readability are assessed. Length is measured in words (adequate up to 470, excessive over 940), and readability in INFLESZ points (suitable if over 55). Results. Length ranged from 73 to 1018 words (mean 360, standard error 8.8, adequate length OR 3.66 ± 0.81). The larger sections were "risks" and "nature of the procedure", and the shorter ones, "alternatives" and "contraindications", P < .0001. The INFLESZ value ranged from 18.1 to 86.4 points (mean 45.8, standard error 0.45), and was better in non-surgical services. Only 12.5% of the documents achieved an INFLESZ value over 55 (OR 0.12 ± 0.03), with 70% in non-surgical procedures, P < .0001. The better readability sections were the "nature" and the "risks", and the worst ones, were "contraindications" and "alternatives", P < .0001. Conclusions. The length of proposed documents is adequate, but they are not sufficiently readable, especially if they come from surgical services. The section length is unbalanced, with "contraindications" and "alternatives" being shorter and more difficult to understand. It is essential to check the readability before using an informed consent document. For this purpose, tools like that proposed could be useful (AU)

Consent for Biobanking: The Legal Frameworks of Countries in the BioSHaRE-EU Project.

Currently, there is no single, Europe-wide regulation of biomedical research using human samples and data. Instead, the law that applies spans a number of areas of law, such as data protection, clinical trials, and tissue regulation. In the absence of harmonized regulation, there is considerable scope for national legal variation. This article analyzes the legislative frameworks that apply to biobanking activities to identify differences in legal requirements between the BioSHaRE-EU project countries: Finland, France, Germany, the Netherlands, Norway, and the United Kingdom. This article highlights the primary role of consent and accompanying governance mechanisms, such as research ethics committee oversight, which enable consent exemptions in the context of research. Our analysis identifies a complicated legal landscape, whereby broadly similar provisions are contained in varied sources of law in each jurisdiction. The challenge for researchers is locating the applicable legal provisions within each national legal framework.

Description of a Mobile-based Electronic Informed Consent System Development.

Seoul National University Hospital constructed and implemented a computer-based informed consent system in December 2011. As of 2013, 30% of the informed consents were still filled out manually on paper. Patients and medical staff continuously suggested the implementation of a system for electronic informed consent using portable devices. Therefore, a mobile-based system for electronic informed consent was developed in 2013 to prevent the issues that arise with computer-based systems and paper informed consent. The rate of filling out electronic informed consent increased from 69% to 95% following the implementation of the mobile-based electronic informed consent. This construction of a mobile-based electronic informed consent system would be a good reference point for the development of a mobile-based Electronic Medical Record and for various mobile system environments in medical institutions.

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)

A single consent for serial anesthetics in burn surgery.

Obtaining anesthesia informed consent for a series of repetitive debridements in burn-injured patients requires a significant time investment for anesthesiologists and patient families. A single consent form was introduced that covered multiple related anesthetics in burn patients. The number of consents per patient before and after implementation was analyzed using Welch ANOVA; Tukey-Kramer post hoc test, with 99% confidence intervals for mean differences was used to examine pairwise comparisons. The mean number of consents per patient was 4.5 ± 2.8 and 1.6 ± 0.51 (P < 0.001) before (2010) and after implementation (2013), respectively. The Multiple Related Anesthetics Consent Form in this population resulted in less time spent by anesthesia providers in obtaining consent for patients undergoing multiple related procedures while providing patient- and family-centric care.

Introducción de un sistema de acreditación para los documentos de consentimiento informado hospitalario / Introduction of an accreditation system for hospital informed consent forms

Objetivo: Describir la creación y funcionamiento de un sistema de acreditación de documentos de consentimiento informado (DCI) como intervención para mejorar su calidad formal y comprobar la mejora obtenida. Material y métodos: Tras una evaluación externa de la calidad de los DCI en un hospital de Murcia (España), se consensuaron los requisitos para los DCI y se diseñaron procedimientos de acreditación y uso. La efectividad se valoró comparando 2 evaluaciones externas del Programa EMCA (2011 y 2013), basadas en 19 criterios y muestras de 60 DCI para cada hospital público de la región. Resultados: Para ser acreditado un DCI debería cumplir 24 criterios: los 19 utilizados en evaluaciones externas, más 3 sobre legibilidad y 2 sobre validez científico-técnica. Se acordó un formulario para implementar los contenidos de cada DCI, que serían revisados y aprobados con vigencia de 5 años. Inicialmente se detectaron 8,2 defectos/DCI. La mejora obtenida fue del 89% (0,9 defectos/DCI), evidenciado mejoras significativas en 18 criterios y marcando benchmark para 16 de los 19 evaluados. Discusión: La acreditación supuso una mejora sustancial de los DCI del hospital (obteniendo el mejor resultado en las evaluaciones externas de su servicio de salud) y garantiza su contenido, legibilidad y comprensión. Ello obliga a valorar la conveniencia de su extensión a otros hospitales, aunque no esté clara la bondad de disponer de DCI comunes. Sin embargo, esta mejora es estructural y no garantiza que la globalidad del proceso de información/consentimiento que soporta se realice adecuadamente, precisando estrategias complementarias para su medición y mejora (AU)

Objective: To describe an accreditation system for informed consent forms (ICF) in a tertiary hospital, as an intervention to improve their quality, and to check the improvements achieved. Material and methods: Following an external evaluation of the ICF quality in a public hospital in Murcia (Spain), an accreditation committee set the ICF requirements and associated procedures. Effectiveness is assessed by comparing two external evaluations carried out by the EMCA Program (2011 and 2013) and based on 19 criteria and a sample of 60 ICF for every public hospital in Murcia Region. Results: To be accredited, every ICF must meet the 19 external criteria plus 5 based on legibility, readability and scientific and technical validity. A form to fill in the contents of every ICF was agreed, which would be reviewed, approved and validated for five years. Before the implementation, 8.2 defects/ICF were detected. The accreditation system obtained an 89% improvement (0.9 defects/ICF) and achieved significant improvements in 18 criteria, 16 of which are benchmarked. Discussion: The accreditation system achieved a substantial improvement in the ICF (obtaining a better result in external evaluations) and guarantees their contents, legibility and readability. This system needs to be extended to other hospitals, since it is not clear whether common ICFs would be suitable. However, this improvement is structural and does not guarantee that the overall information/consent procedure is done properly, thus complementary strategies for measurement and improvement are required (AU)

Development of a Web-based surgical booking and informed consent system to reduce the potential for error and improve communication.

BACKGROUND: The decision to perform an elective procedure often originates during an office visit between surgeon and patient. Several administrative tasks follow, including scheduling or "booking" of the case and obtaining informed consent. These processes require communicating accurate information regarding diagnosis, procedure, and other patient-specific details necessary for the safe and effective performance of an operation. Nonstandardized and paper-based consents pose difficulty with legibility, portability, and consistency, thereby representing a source of potential error and inefficiency. There are numerous barriers to efficiently booking elective surgical procedures and obtaining a legible, complete, and easily retrievable informed consent. An integrated Web-based booking and consent system was developed at a multisite university-affiliated community hospital system to improve the speed and quality of work flow, as well as communication with both the patients and staff. METHODS: A booking and consent system was developed and made available over the intranet. This customized system was created by leveraging existing information systems. RESULTS: The electronic consent system uses surgeon-specific templates and allows for a consistent approach to each procedure. A printed consent form can be generated at any time from any of the health care system's three campuses and is commonly stored in the electronic medical record. Integration into our perioperative system allows for coordination with the operating room staff, administrative personal, financial coordinators, and central supply. Total systems expenditure for development was estimated at $40,000 (US). CONCLUSIONS: Organizations considering standardizing their own consent and operating room booking processes can review this experience in making their own "make or buy" decision for their own settings.

Documenting informed consent in elective hip replacement surgery: a simple change in practice.

Adequate documentation of informed consent is an important aspect of many doctors' work and failings in this area may result in patient dissatisfaction or litigation. In 2009 the documentation of risks and complications on the consent forms of patients undergoing primary hip replacement was audited at a specialist centre. Following this audit procedure-specific complication stickers were introduced in an attempt to improve the documentation of the consent process. This article discusses the results of a re-audit and aims to determine if this change in practice had resulted in any significant improvement in documentation. The consent forms of 100 consecutive patients undergoing primary total hip replacement were re-audited using a standardized data collection sheet in order to close the audit loop. The re-audit found that 86 consent forms used the procedure-specific complication sticker to list the potential complications associated with a total hip replacement. Statistically significant improvements in the documentation of fracture, neurovascular damage, leg length discrepancy, failure, premature loosening, death, medical complications, ongoing pain, stiffness, wound healing problems and other were all seen in the 2012 re-audit in comparison to the 2009 audit (P<0.0001). The cheap and simple introduction of procedure-specific complication stickers in order to help surgeons document the process of informed consent has resulted in significant improvements in practice. In the context of patient-focused care and satisfaction in the NHS, it is vital that simple measures such as the introduction of procedure-specific complication stickers are embraced.

Preserving participant anonymity during remote preenrollment consent form checking.

BACKGROUND: In biomedical research, the consent form must comply with regulatory requirements. Checking for compliance typically has been performed on-site and most frequently after a participant's final enrollment. We use a procedure for remote preenrollment checking of consent forms that protects participant identities. This procedure requires a copy of the consent form that partially masks the fields for participant's name and signature; this copy is faxed to the clinical trials unit for checking. PURPOSE: To describe our efforts to identify an appropriate printed masking pattern. We tried several patterns that permit ascertainment of the presence of signatures and names and evaluated each one with respect to degree of masking participant identities. METHODS: We assessed the efficiency of a satisfactory pattern through an experiment. We created forms with variants of the masking pattern on the copy to be faxed. We completed the forms with fictitious identities before copies were faxed and checked by clinical research associates. We measured the rate of empty and filled fields detected and the rate of letters and names correctly read. The target was defined as 100% for the rate of empty and filled fields detected and 0% for the rate of letters and names correctly read. RESULTS: The best masking pattern allowed the detection of 100% empty and filled fields and the reading of 0% names and 19% letters. Consequently, the consent form with the selected masking pattern has been used routinely in our clinical trials unit. LIMITATIONS: We tested only five fictitious identities, five individuals who completed forms, and three who checked forms. Also, we initially considered only four patterns and variations in them. CONCLUSIONS: We defined a masking pattern that satisfactorily fulfilled our needs for confidentiality. This and other procedures for remote preenrollment checking of consent form can be a key component of a risk-based monitoring strategy.

Remote preenrollment checking of consent forms to reduce nonconformity.

BACKGROUND: In biomedical research, the signed consent form must be checked for compliance with regulatory requirements. Checking usually is performed on site, most frequently after a participant's final enrollment. PURPOSE: We piloted a procedure for remote preenrollment consent forms checking. We applied it in five trials and assessed its efficiency to reduce form nonconformity before participant enrollment. METHODS: Our clinical trials unit (CTU) routinely uses a consent form with an additional copy that contains a pattern that partially masks the participant's name and signature. After completion and signatures by the participant and investigator, this masked copy is faxed to the CTU for checking. In case of detected nonconformity, the CTU suspends the participant's enrollment until the form is brought into compliance. We checked nonconformities of consent forms both remotely before enrollment and on site in five trials conducted in our CTU. We tabulated the number and nature of nonconformities by location of detection: at the CTU or on site. We used these data for a pseudo before-and-after analysis and estimated the efficiency of this remote checking procedure in terms of reduction of nonconformities before enrollment as compared to the standard on-site checking procedure. We searched for nonconformity determinants among characteristics of trials, consent forms, investigator sites, and participants through multivariate logistic regression so as to identify opportunities for improvement in our procedure. RESULTS: Five trials, starting sequentially but running concurrently, with remote preenrollment and on-site checking of consent forms from 415 participants screened in 2006-2009 led to 518 consent forms checked; 94 nonconformities were detected in 75 forms, 75 (80%) remotely and 19 more (20%) on site. Nonconformities infrequently concerned dates of signatures (7%) and information about participants (12%). Most nonconformities dealt with investigator information (76%), primarily contact information (54%). The procedure reduced nonconformities by 81% (95% confidence interval (CI): 73%-89%) before enrollment. Nonconforming consent forms dropped from 25% to 0% over the period, indicating a rapid learning effect between trials. Fewer nonconformities were observed for participants screened later in a trial (odds ratio (95% CI): 0.5 (0.3-0.8); p = 0.004), indicating a learning effect within trials. Nonconformities were more common for participants enrolled after screening (2.4 (1.1-5.3); p = 0.03), indicating a stricter scrutiny by form checkers. LIMITATIONS: Although our study had a pseudo before-and-after design, no major bias was identified. Power and generalizability of our findings were sufficient to support implementation in future trials. CONCLUSIONS: This procedure substantially limited nonconformity of consent forms with regulatory requirements before enrollment, thus proving a key component of a risk-based monitoring strategy that has been recommended to optimize resources for clinical research.

Looking at research consent forms through a participant-centered lens: the PRISM readability toolkit.

Communicating in lay language is an underdeveloped skill among many researchers-a limitation that contributes to low readability among research consent forms and may hinder participant understanding of study procedures and risks. We present the Project to Review and Improve Study Materials (PRISM) and its centerpiece, the PRISM Readability Toolkit. The toolkit provides strategies for creating study materials that are readable and participant centered, focusing on consent forms but also addressing other participant materials. Based on plain language principles, this free resource includes a flexible menu of tools, such as an editing checklist, before and after examples, easy-to-read template language, and a list of alternative words. Among PRISM's ongoing goals is to test the toolkit with populations groups.

Orthognathic surgery: a new preoperative informed consent model.

The authors of this study propose a new informed consent form for orthognathic surgery. In a previous study from 2004, a careful review of the international literature and clinical practice suggested the feasibility of dividing the informed consent form into 2 parts, one describing diagnostic procedures and therapeutic/surgical times, and another describing possible problems. During these 4 years, we noticed that this model has 2 setbacks. We replaced point 2, "temporomandibular joint disorders," with "postoperative temporomandibular joint derangement," so that the surgeon is now supposed to inform the patient on the possibility of condylar dislocations, condylar sag, and clockwise/anticlockwise rotations of occlusal surface after surgery. We also changed point 5, "tooth and periodontal disease," in "tooth damage, avulsion, and periodontal disease" because we believe patients should be informed better on the risk of injuries to the dental elements such as fractures, luxations, or avulsions, especially to incisors. In the opinion of the authors, this new informed consent form allows the patient to know the risks related to the orthodontic/surgical therapy better, thus preserving the surgeons from the civil risk and penalties of omission.

Trust in early phase research: therapeutic optimism and protective pessimism.

Bioethicists have long been concerned that seriously ill patients entering early phase ('phase I') treatment trials are motivated by therapeutic benefit even though the likelihood of benefit is low. In spite of these concerns, consent forms for phase I studies involving seriously ill patients generally employ indeterminate benefit statements rather than unambiguous statements of unlikely benefit. This seeming mismatch between attitudes and actions suggests a need to better understand research ethics committee members' attitudes toward communication of potential benefits and risks of early phase studies to potential subjects. We surveyed the members of two U.S. research ethics committees using a phase I gene transfer study scenario, and compared the results to a previous survey of potential subjects' perceptions and attitudes toward benefit and risk for the same protocol. The results show that there is indeed a gap between the subjects' perceptions and the committee members' views on what is appropriate to be communicated to research subjects. This discrepancy is the product of both the commonly assumed optimism of the subjects and to a "protective pessimism" of the research ethics committee members. We discuss this discrepancy using "frameworks of trust" and demonstrate the need to incorporate these frameworks into the existing model of informed consent.