scholarly journals An instrument for assessing the quality of informed consent documents for elective procedures: development and testing

BMJ Open ◽  
2020 ◽  
Vol 10 (5) ◽  
pp. e033297 ◽  
Author(s):  
Erica S Spatz ◽  
Lisa G Suter ◽  
Elizabeth George ◽  
Mallory Perez ◽  
Leslie Curry ◽  
...  
Keyword(s):  
Informed Consent ◽  
Working Group ◽  
Iterative Development ◽  
Starting Point ◽  
Item Level ◽  
Consent Document ◽  
Patient Advocates ◽  
Informed Consent Document ◽  
Stakeholder Input

ObjectiveTo develop a nationally applicable tool for assessing the quality of informed consent documents for elective procedures.DesignMixed qualitative-quantitative approach.SettingConvened seven meetings with stakeholders to obtain input and feedback on the tool.ParticipantsTeam of physician investigators, measure development experts, and a working group of nine patients and patient advocates (caregivers, advocates for vulnerable populations and patient safety experts) from different regions of the country.InterventionsWith stakeholder input, we identified elements of high-quality informed consent documents, aggregated into three domains: content, presentation and timing. Based on this comprehensive taxonomy of key elements, we convened the working group to offer input on the development of an abstraction tool to assess the quality of informed consent documents in three phases: (1) selecting the highest-priority elements to be operationalised as items in the tool; (2) iteratively refining and testing the tool using a sample of qualifying informed consent documents from eight hospitals; and (3) developing a scoring approach for the tool. Finally, we tested the reliability of the tool in a subsample of 250 informed consent documents from 25 additional hospitals.OutcomesAbstraction tool to evaluate the quality of informed consent documents.ResultsWe identified 53 elements of informed consent quality; of these, 15 were selected as highest priority for inclusion in the abstraction tool and 8 were feasible to measure. After seven cycles of iterative development and testing of survey items, and development and refinement of a training manual, two trained raters achieved high item-level agreement, ranging from 92% to 100%.ConclusionsWe identified key quality elements of an informed consent document and operationalised the highest-priority elements to define a minimum standard for informed consent documents. This tool is a starting point that can enable hospitals and other providers to evaluate and improve the quality of informed consent.

scholarly journals Quality of informed consent documents among US. hospitals: a cross-sectional study

BMJ Open ◽  
2020 ◽  
Vol 10 (5) ◽  
pp. e033299
Author(s):  
Erica S Spatz ◽  
Haikun Bao ◽  
Jeph Herrin ◽  
Vrunda Desai ◽  
Sriram Ramanan ◽  
...  
Keyword(s):  
Informed Consent ◽  
Cross Sectional Study ◽  
Face Validity ◽  
Fee For Service ◽  
Cross Sectional ◽  
Consent Document ◽  
Informed Consent Document ◽  
The Mean ◽  
Quality Threshold

ObjectiveTo determine whether informed consent for surgical procedures performed in US hospitals meet a minimum standard of quality, we developed and tested a quality measure of informed consent documents.DesignRetrospective observational study of informed consent documents.Setting25 US hospitals, diverse in size and geographical region.CohortAmong Medicare fee-for-service patients undergoing elective procedures in participating hospitals, we assessed the informed consent documents associated with these procedures. We aimed to review 100 qualifying procedures per hospital; the selected sample was representative of the procedure types performed at each hospital.Primary outcomeThe outcome was hospital quality of informed consent documents, assessed by two independent raters using an eight-item instrument previously developed for this measure and scored on a scale of 0–20, with 20 representing the highest quality. The outcome was reported as the mean hospital document score and the proportion of documents meeting a quality threshold of 10. Reliability of the hospital score was determined based on subsets of randomly selected documents; face validity was assessed using stakeholder feedback.ResultsAmong 2480 informed consent documents from 25 hospitals, mean hospital scores ranged from 0.6 (95% CI 0.3 to 0.9) to 10.8 (95% CI 10.0 to 11.6). Most hospitals had at least one document score at least 10 out of 20 points, but only two hospitals had >50% of their documents score above a 10-point threshold. The Spearman correlation of the measures score was 0.92. Stakeholders reported that the measure was important, though some felt it did not go far enough to assess informed consent quality.ConclusionAll hospitals performed poorly on a measure of informed consent document quality, though there was some variation across hospitals. Measuring the quality of hospital’s informed consent documents can serve as a first step in driving attention to gaps in quality.

Informed Consent Document and Process in India: Ethical and Quality Issues

2016 ◽  
Vol 8 (1) ◽  
pp. 37-52
Author(s):  
Madhuri Patel ◽  
Kannan Sridharan ◽  
Jayesh Patel
Keyword(s):  
Informed Consent ◽  
Consent Document ◽  
Informed Consent Document ◽  
Quality Issues

scholarly journals Analysis of Informed Consent Document Utilization in a Minimal-Risk Genetic Study

2011 ◽  
Vol 155 (5) ◽  
pp. 316 ◽  
Author(s):  
Karl Desch ◽  
Jun Li ◽  
Scott Kim ◽  
Naomi Laventhal ◽  
Kristen Metzger ◽  
...  
Keyword(s):  
Informed Consent ◽  
Genetic Study ◽  
Minimal Risk ◽  
Consent Document ◽  
Informed Consent Document

scholarly journals 知情同意臨床實踐實證研究——第一人稱視角的考察

2017 ◽  
Vol 15 (2) ◽  
pp. 9-20
Author(s):  
Hua CHEN ◽  
Yonghui MA
Keyword(s):  
Informed Consent ◽  
Individual Autonomy ◽  
Medical Treatments ◽  
Legal Implications ◽  
Patient’S Autonomy ◽  
Digital Commons ◽  
Consent Document ◽  
Informed Consent Document ◽  
China Today ◽  
Medical Policy

LANGUAGE NOTE | Document text in Chinese; abstract also in English.知情同意作為一項權利，患者成為闡述其體驗的首要主體。實證調查表明，患者對於其權利認知還存在不足，多數偏好於患者與家庭共用模式；在實踐中，知情與同意在主體層面存在分離現象。對於病情的告知傾向於任選模式，但家庭是不可或缺的告知物件，對於診療、護理等相關資訊，傾向於患者模式；在同意方面，家屬成為獲取同意的主體。經濟因素成為患方“不同意”的首要原因。對於不同維度的調查表明，基於女性相對脆弱性特點，他們對於家庭的依賴性更強，其維權意識更強；在年齡層面，青少年對於權利的認知更理性，具有現代契約精神。在地域層面，縣級以上城市居民對於權利認知度更高；職業往往與教育程度相關，表明農民的個體依賴性更強；政府機關以及事業單位人員個體主體性更強。為此，需要加強患者權利教育，提升主體意識；對醫務人員加強職業道德教育，履行告知義務，強化醫患信任；深化醫療衛生體制改革，為知情同意的踐行提供空間與時間。An informed consent document is vital for all surgical procedures and medical treatments. Proper documentation and counseling of patients is important for informed consent. Opinion polls conducted in this essay show that the majority of people in China today have accepted informed consent as a legally binding medical policy, yet they do not fully understand the ethical and legal connotations involved, particularly the idea of the patient’s autonomy. As a result, the patient’s own experience as a first-person narrative is often ignored and his/her subjectivity is blurred when his/her family’s subjectivity intervenes. According to the essay, the problem appears when liberalism—which emphasizes individual autonomy and rights—does not square with the Confucian tradition that emphasizes family as a coherent unit. The essay also points out that there is a huge difference in patients’ perceptions of “individual rights,” due to their different levels of education. The author argues that informed consent could be better practiced if both doctors and patients were “well informed” and understood the moral and legal implications of informed consent.DOWNLOAD HISTORY | This article has been downloaded 97 times in Digital Commons before migrating into this platform.

General Informed Consent Document Survey

2009 ◽  
Author(s):  
José Granero-Molina ◽  
Cayetano Fernández-Sola ◽  
Gabriel Aguilera-Manrique
Keyword(s):  
Informed Consent ◽  
Consent Document ◽  
Informed Consent Document

scholarly journals Informed consent: A study of patients with life-threatening illnesses

2015 ◽  
Vol 24 (4) ◽  
pp. 430-440 ◽  
Author(s):  
Montserrat Busquets ◽  
Jordi Caïs
Keyword(s):  
Informed Consent ◽  
Health Sector ◽  
Ethical Considerations ◽  
Consent Document ◽  
Key Factor ◽  
Life Threatening ◽  
Informed Consent Document ◽  
The Moment ◽  
Spanish Health ◽  
The Relationship

Background: The relationship between healthcare professionals and patients in the Spanish health sector has undergone dramatic change. One aspect of this is that the use of informed consent has become a key factor in the delivery of adequate healthcare. But although a certain period of time has already passed since informed consent started to be used, in Spain there is still doubt about how adequately informed consent is being used. Objectives: (a) To look at how patients understand the notion and purpose of informed consent, and (b) how the informed consent is applied – the way patients receive such information affects their level of participation and decision making during the time they receive medical care. Methodology: We use interpretative description of interviews with patients. We developed guiding questions for the interviews with patients in two preliminary and exploratory focus groups. Then, we carried out 20 personal open-ended interviews with 20 purposive selected patients with illnesses that had a serious impact on their lives. Ethical considerations: Permission from ethical committees and institutions involved in the study, and consent and confidentiality were ensured before conducting the research. Results: The findings show that while patients agreed that their consent should be necessary for health professionals to be able to intervene, they had serious difficulty obtaining and then understanding information offered to them at the moment when they were being asked to sign informed consent documents. The participants were critical of the consent documents, which they considered were treated as merely a formality and even some of them had felt coerced to sign. Discussion: Participants confirmed that the informed consent documents that they signed did not meet their ethical objectives. Their perception of the purpose of consent indicates that informed consent document may still be largely understood as a formality rather an ethical obligation.

scholarly journals Informed Consent Document (ICD) as Educational Tool for Medical School

2013 ◽  
Vol 5 (2) ◽  
Author(s):  
Prithpal Singh Matreja ◽  
Amandeep Singh ◽  
Ashwani K Gupta ◽  
Jaspreet Kaur
Keyword(s):  
Informed Consent ◽  
Medical School ◽  
Educational Tool ◽  
Consent Document ◽  
Informed Consent Document

Applying a Sociolinguistic Model to the Analysis of Informed Consent Documents

2009 ◽  
Vol 16 (6) ◽  
pp. 797-812 ◽  
Author(s):  
José Granero-Molina ◽  
Cayetano Fernández-Sola ◽  
Gabriel Aguilera-Manrique
Keyword(s):  
Laparoscopic Surgery ◽  
Informed Consent ◽  
Professional Communication ◽  
Linguistic Communication ◽  
Risks And Benefits ◽  
Documentary Analysis ◽  
Communication Difficulties ◽  
Consent Document ◽  
Informed Consent Document ◽  
Voluntary Basis

Information on the risks and benefits related to surgical procedures is essential for patients in order to obtain their informed consent. Some disciplines, such as sociolinguistics, offer insights that are helpful for patient—professional communication in both written and oral consent. Communication difficulties become more acute when patients make decisions through an informed consent document because they may sign this with a lack of understanding and information, and consequently feel deprived of their freedom to make their choice about different treatments or surgery. This article discusses findings from documentary analysis using the sociolinguistic SPEAKING model, which was applied to the general and specific informed consent documents required for laparoscopic surgery of the bile duct at Torrecárdenas Hospital, Almería, Spain. The objective of this procedure was to identify flaws when information was provided, together with its readability, its voluntary basis, and patients’ consent. The results suggest potential linguistic communication difficulties, different languages being used, cultural clashes, asymmetry of communication between professionals and patients, assignment of rights on the part of patients, and overprotection of professionals and institutions.

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