Incapacity in childbirth – rare or common?
Neelam Singh, Peter Lepping, Rhiannon Whitaker, Barkat Masood, Shweta Joshi, Philip Banfield
European Journal of Obstetrics & Gynecology and Reproductive Biology, 29 January 2021
Abstract
Objective
Impaired decision making ability is common on general medical wards. Audit evidence suggests that the prevalence of incapacity may be higher than previously assumed in Obstetric Emergency Procedures (OEP) during childbirth. We investigated the prevalence of incapacity in OEP and factors associated with this.
Design
Capacity to consent to treatment was assessed retrospectively in 93 women undergoing OEP. All women were interviewed using a semi-structured questionnaire aided interview within 24 hours of the emergency. Five assessors (3 obstetricians and 2 psychiatrists) were asked to determine capacity to consent from audio recordings of the interviews.
Results
All 5 assessors determined 59% of women to have capacity to consent to treatment and 2% of women to lack capacity. In 39% of women there was some disagreement between assessors. Using a majority decision (3 assessors in agreement), 14% of women lacked capacity. High pain scores, young age and no previous history of theatre deliveries were associated with more incapacity judgments, whilst parity and history of mental illness were not. Using a 7point Likert scale only marginally improved agreement between assessors, compared to their binary decision.
Conclusion
It is often assumed that it is rare to lack capacity in an obstetric emergency procedure during childbirth, but these data suggest that incapacity may be relatively common. In particular, severe pain is a demonstrable risk factor for impaired capacity. Wide variation between assessors questions the validity of current commonly employed (informal) methods used in clinical practice to assess capacity to consent during OEP.
Month: March 2021
The Concept of “Person” in the Italian Legislation on Informed Consent and Advance Healthcare Directives
The Concept of “Person” in the Italian Legislation on Informed Consent and Advance Healthcare Directives
Matteo Cresti
International Journal for the Semiotics of Law, 10 February 2021
Open Access
Abstract
The aim of the paper is that of investigating the concept of “person” in the context of Italian law on informed consent and advance healthcare directives (law n. 219/2017). The following paper will first consider the importance of the concept of “person” within bioethics; secondly it will exhibit how there are different levels of bioethics, and that on the discussion level of laws and regulations, concepts worthy of metaphysical and value references cannot be used, because they must be shared by everyone in a pluralistic society. I’ll then move on to discuss the law on informed consent and advance healthcare directives; first I’ll discuss the references to the Italian Constitution, showing that the implied concept of “person” is closely linked to the concepts of “equality” and “autonomy”, and finally I’ll discuss the particular case of minors and the protection that the law provides them.
[Expert consensus on informed consent for vaccination(Part One)]
[Expert consensus on informed consent for vaccination(Part One)]
Zhonghua Yu Fang Yi Xue Za Zhi
Chinese Preventive Medicine Association, 1 February 2021; 55(2) pp 135-166
Abstract
The Vaccine Administration Law of the People’s Republic of China and other relevant laws require that vaccine recipients or their guardians be educated about vaccines and how they work, and described in general the methods and contents of such vaccination education. With the new law and “Standard Operational Procedures for Immunization” as foundation documents, and in consultation with experts at home and abroad, the Chinese Preventive Medicine Association developed a consensus statement about informed consent for vaccination. This consensus statement is written for disease control and prevention health care personnel in vaccination services and describes the educational content of informed consent, a theoretical framework for immunization and immunization knowledge, the informed consent processes, principles of planning for vaccination, and an informed consent form. Part One of the consensus includes the general principles of vaccination and provides specific information on hepatitis B vaccine, Bacillus Calmette-Guérin vaccine, poliomyelitis vaccine, diphtheria, tetanus and pertussisvaccine, measles-containing vaccine, Japanese encephalitis vaccine, meningococcal vaccine, and hepatitis A vaccine.
Editor’s note: This is a Chinese language publication
Our land is banked: forest rights, consent and the invention of a legal exception as land banks
Our land is banked: forest rights, consent and the invention of a legal exception as land banks
Arpitha Kodiveri
International Journal of Human Rights, 3 February 2021
Abstract
Land banks are a newly created administrative mechanism managed by the Odisha Industrial and Infrastructure Corporation (IDCO) and the Revenue and Disaster Management Department. Their purpose is to provide large parcels of land to industries with minimal procedural hassles in the acquisition. Thus, the administrative authorities put in place an intricate web of legal interpretations that enable it to bypass due process requirements. The legal landscape in India’s forests transformed with the passing of the Forest Rights Act,2006 in the direction of democratisation and participation of forest-dwelling communities. An essential part of this legal framework was the right to free, prior, and informed consent of the village assembly. In this paper, through case studies and examples I argue that a space of exception is created within the law through the mechanism of land banks to prevent the applicability of the consent provision. This sophisticated legal interpretive exercise by the administrative authority results in the violation of the human right to free, prior, and informed consent of forest-dwelling communities in Odisha.
Informed Consent Rates For Neonatal Randomized Controlled Trials In Low And Lower-Middle Income Countries Versus High-Income Countries: A Systematic Review
Informed Consent Rates For Neonatal Randomized Controlled Trials In Low And Lower-Middle Income Countries Versus High-Income Countries: A Systematic Review
Denise Jones, Syed Taha, Michael S. Jones, Melissa Bauserman, Stuti Pant, Carl Bose, Sudhin Thayyil, Jackie K. Patterson and Paolo Montaldo
Pediatrics, March 2021; 147(3) pp 246-247
Abstract
Background – Consent rates for research studies in low- and lower middle-income countries (LMICs) are often greater than 90%. Uniformly high consent rates raise ethical concerns regarding the extent to which consent is both autonomous and informed. This study aimed to characterize consent rates for neonatal randomized controlled trials (RCTs) in LMICs compared to high-income countries (HICs). Methods – We searched MEDLINE, EMBASE and Cochrane for neonatal RCTS in LMICs or HICs published between 2013 and 2018. Given the disproportionately high number of HIC articles in the initial search, we used a random number generator to select a subset of HIC…
Written Informed Consent—Translating into Plain Language. A Pilot Study
Written Informed Consent—Translating into Plain Language. A Pilot Study
Agnieszka Zimmermann, Anna Pilarska, Aleksandra Gaworska-Krzemińska, Jerzy Jankau, Marsha N. Cohen
Healthcare, 20 February 2021; 9(2)
Abstract
Background
Informed consent is important in clinical practice, as a person’s written consent is required prior to many medical interventions. Many informed consent forms fail to communicate simply and clearly. The aim of our study was to create an easy-to-understand form.
Methods
Our assessment of a Polish-language plastic surgery informed consent form used the Polish-language comprehension analysis program (jasnopis.pl, SWPS University) to assess the readability of texts written for people of various education levels; and this enabled us to modify the form by shortening sentences and simplifying words. The form was re-assessed with the same software and subsequently given to 160 adult volunteers to assess the revised form’s degree of difficulty or readability.
Results
The first software analysis found the language was suitable for people with a university degree or higher education, and after revision and re-assessment became suitable for persons with 4–6 years of primary school education and above. Most study participants also assessed the form as completely comprehensible.
Conclusions
There are significant benefits possible for patients and practitioners by improving the comprehensibility of written informed consent forms.
Enhancing the ethical conduct of a longitudinal cluster-randomized trial of psychosocial stimulation intervention for children with complicated severe acute malnutrition through Rapid Ethical Assessment: a qualitative study
Enhancing the ethical conduct of a longitudinal cluster-randomized trial of psychosocial stimulation intervention for children with complicated severe acute malnutrition through Rapid Ethical Assessment: a qualitative study
Research Article
Tesfalem T. Tessema, Andamlak G. Alamdo, Eyoel B. Mekonnen, Fanna A. Debele, Juhar A. Bamud, Teklu G. Abessa & Tefera Belachew Lema
BMC Medical Ethics, 4 February 2021; 22(10)
Open Access
Abstract
Background
Informed consent is a universally accepted precondition for scientific researches involving human participants. However, various factors influence the process of obtaining authentic informed consent, and researchers particularly working in resource-poor countries often face considerable difficulties in implementing the universally recommended procedures for obtaining informed consent. We have conducted this Rapid Ethical Assessment (REA) to accommodate the local cultural norms and to understand the relevant ethical issues in the Silti community before the conduct of a cluster-randomized controlled trial.
Methods
This REA was conducted in two purposively selected Woredas/Districts and Worabe Town administration of Silti Zone. Data were collected using in-depth interviews and focus group discussions. Purposive and convenient sampling techniques were used to select respondents. Five in-depth interviews and 15 Focus Group Discussions were conducted in the Amharic language. The collected data was transcribed, translated, and analyzed using a thematic approach.
Result
Most of the community members never heard about research and therapeutic misconception was common. In the area, the permission of people working in the formal and informal community administration is essential before approaching individuals. The male head of the household should also be involved in the decision before individual household members participate in research. Furthermore, sensitizing the community using public and religious gatherings was suggested before individual recruitment. In the consent process, delivering selected information particularly the purpose and benefits of the research was emphasized and the tendency of preferring verbal consent was documented despite the willingness of the individuals to sign on the consent form. Local health workers were identified as appropriate personnel to communicate information and the procedures of the research were found to be acceptable. However, the value of small incentives was suggested to motivate potential participants. Finally, involving all concerned stakeholders and respecting the cultural norm of the community was emphasized.
Conclusion
Through REA, we understand the research awareness of the community, their expectation, and the cultural norms relevant to the ethical conduct of research. It enabled us to devise culturally sensitive and scientifically sound strategies to secure authentic informed consent. The process of conducting REA was found to be feasible, quick, and efficient.
Knowledge, Attitude, and Practice about informed consent amongst Resident doctors at Rural Medical Institute of Central India
Knowledge, Attitude, and Practice about informed consent amongst Resident doctors at Rural Medical Institute of Central India
Shashank Gotarkar, Prakash Mohite, Kumar Bijyendra Sourabh, Alka Rawekar
Indian Journal of Forensic Medicine & Toxicology, January-March 2021; 15(1)
Open Access
Abstract
Informed consent is the process by which the treating health-care provider discloses appropriate information to the patient so that the patient may make a voluntary choice to accept or refuse treatment. There are few studies done amongst the medical residents in India about informed consent. The residents are the stepping stone of the Medical profession, it is proposed that the perception about the informed consent amongst the residents shall be sought.Hence, the study was undertaken with the aim, to appraise the knowledge, attitude, and practices of residents of all three years toward ‘informed consent taking’ with the objectives of assessing and comparing the knowledge, attitude and practices of obtaining informed consent. The survey questionnaire was circulated and data was collated. It was developed in Knowledge, Attitude and practice domain and analysis was done. Based on the result, it was concluded that, in all three domains, there was ascendency of Knowledge, Attitude and Practice in three years of resident doctors.
The readability of informed consent forms for research studies conducted in South Africa
The readability of informed consent forms for research studies conducted in South Africa
A E Fischer, W D F Venter, S Collins, M Carman, S T Lalla-Edward
South African Medical Journal, February 2021; 111(2)
Open Access
Abstract
Background
Informed consent forms (ICFs) are used to obtain consent from participants. However the complexity and comprehensiveness of these forms may not be appropriate. Readability can be quantified by formulas in Microsoft (MS) Word, such as the Flesch Reading Ease test. The South African (SA) ethics guidelines suggest that the MS Word Flesch-Kincaid Reading Grade score should be used to assess the complexity of ICFs and should be the equivalent of grade 8 level, or lower.
Objectives
To use readability formulas to determine whether current SA ICFs are appropriate for the general population.
Methods
This was a descriptive study of a sample of English ICFs (solicited from our studies, as well as from local researchers) which received approval from local ethical review boards during the past 5 years, for prospective (≥6 months) drug studies that explored treatment and prevention of HIV, tuberculosis, diabetes or cardiovascular disease. ICFs were evaluated in MS Word for Flesch Reading Ease and Flesch-Kincaid Reading Grade, with the Simple Measure of Gobbledygook (SMOG) index calculated using www.readabilityformulas.com. Recommended targets for easy readability are above 60 for the Flesch Reading Ease score, and less than or equal to a grade 8 reading level for the Flesch-Kincaid Reading Grade and SMOG.
Results
A total of 75 consent forms from 35 individual research studies conducted in SA over the last 5 years were included. The consent forms had been approved by six ethics committees across seven of the SA provinces. The median (interquartile range (IQR)) Flesch Reading Ease score was 55.8 (48.7 – 59.7) and 18 (25.0%) of the ICFs had easy or standard readability, while the median (IQR) Flesch-Kincaid Grade was 10.2 (8.8 – 11.4), with 23 (30.6%) at least a grade 8 level or lower. The median (IQR) SMOG index scored below grade 8 level.
Conclusions
Two-thirds of the ICFs from this study fail to meet the SA readability standard, a result matched by using alternative readability formulas. Readability can be improved with simple techniques and by actively monitoring readability metrics.
The practice of obtaining informed consent for elective surgery and anesthesia from patients’ perspective: An institutional based cross-sectional study
The practice of obtaining informed consent for elective surgery and anesthesia from patients’ perspective: An institutional based cross-sectional study
Research Article
Tadese Tamire, Aragaw Tesfaw
Clinical Ethics, 8 February 2021
Abstract
Introduction
Informed consent is a body of shared decision-making process and voluntary authorization of patients to receive medical or surgical intervention. There are limited studies conducted so far to examine the practice of informed consent in Ethiopia. This study aimed to assess the practice of informed consent process for surgery and Anesthesia.
Method
A cross-sectional study was conducted from March to May 2019. The data were collected using interviewer-administered structured questionnaire and analyzed in SPSS version 23.
Results
A total of 139 patients were interviewed in this study. Most 42(30.2%) of patients were in the age group of 29–38 years. Nearly half 68 (48.9%) of the patients were informed the benefits of the surgical procedure and 78(56.1%) of the patients were informed on the type of anesthesia to be administered while 65 (46.8%) were not informed on any complication related to the anesthesia. About 66 (47.5%) of patients were informed on alternatives to the surgery. Of these patients, 39(59%) were not informed of any benefits and possible risks associated with the alternative modes of treatment. About half (54%) of the patients were reported as they were understood the information provided during the pre-operative informed consent process.
Conclusion
This research revealed that patients were inadequately informed on the complications of proposed procedure, alternative forms of treatment, risks and benefits of the proposed procedure. Therefore, healthcare providers should provide adequate information regarding the proposed procedure and make sure whether patients understood the risks and benefits before the consent.
Center for Informed Consent Integrity 