Patient satisfaction with surgical informed consent at Jimma Medical Center, Ethiopia
Research article
Tsegaw Biyazin, Ayanos Taye & Yeshitila Belay
BMC Medical Ethics, 25 October 2022; 23(103)
Open Access
Abstract
Background
Informed consent is a process in which a healthcare provider obtains permission from an individual prior to surgery. Patient satisfaction with the informed consent process is one of the main indicators of healthcare service quality. This study aimed to assess patient satisfaction with surgical informed consent at Jimma Medical Center, Ethiopia, in 2020.
Methods
A facility-based cross-sectional study was conducted from April 1 to June 30, 2020, at Jimma Medical Center. Face-to-face interviews were conducted using structured questionnaires. A systematic sampling technique was used to select the study participants. The collected data were coded, entered into Epi data version 3.1, and analyzed using SPSS version 25. Bivariate and multivariate regression analyses were performed to determine the association between patient satisfaction and socio-demographic and facility-related factors. In multivariate regression, predictors with a P-value of < 0.05 were considered statistically significant.
Results
Totally 372 study participants were interviewed with a response rate of 97.8%. Nearly two-fifths (43%) of patients were satisfied with surgical informed consent. Living in an urban area (AOR: 2.279, 95% CI 1.257–4.131), having current referred history (AOR: 1.856, 95% CI 1.033–3.337), consent form version (AOR: 2.076, 95% CI 1.143–3.773), time spent on the provision of informed consent (AOR: 5.227, 95% CI 2.499–10.936) and having better patient-health providers relationship (AOR: 5.419, 95% CI 3.103–9.464) predictors were positively associated with patient satisfaction.
Conclusion
Patient satisfaction with the surgical informed consent process was relatively low. Therefore, Health care professionals need to emphasize a way of delivering informed consent, patients’ needs and obey a standard informed consent to improve patient satisfaction.

Making Removals Part of Informed Choice: A Mixed-Method Study of Client Experiences With Removal of Long-Acting Reversible Contraceptives in Senegal
Aurélie Brunie, Fatou Ndiaté Rachel Sarr Aw, Salif Ndiaye, Etienne Dioh, Elena Lebetkin, Megan M. Lydon, Elizabeth Knippler, Sarah Brittingham, Marème Dabo, Marème Mady Dia Ndiaye
Global Health: Science and Practice, October 2022; 10(5)
Open Access
Abstract
Background
Ensuring access to removal services for implants and intrauterine devices (IUDs) is essential to realize informed choice and voluntary family planning. We document removal desires and experiences among women who received an implant or IUD from the public sector in 3 districts of Senegal.
Methods
We conducted a phone survey of 1,868 implant and IUD users, 598 follow-up surveys with those who had ever asked a provider for a removal, and 24 in-depth interviews (IDIs) with women who had ever wanted an implant removal. We analyzed survey data descriptively and IDI data thematically.
Results
Fifty-eight percent of implant users and 54% of IUD users reported having wanted a removal. Desired pregnancy and contraceptive-induced menstrual changes (CIMCs) were the main reasons for removal desires. Fifty-four percent of implant users and 55% of IUD users who asked a provider for a removal reported challenges accessing services, with over two-thirds noting long lines or wait times. Sixty-three percent of implant users and 73% of IUD users who saw a provider were satisfied with the outcome of their first interaction. Over 90% of participants had not been told about the removal cost at insertion. Almost all participants who had their method removed obtained a complete removal during their first clinical procedure. Around two-thirds of participants who obtained a removal did not take up another method at that time. IDIs confirmed the influence of CIMCs on removal desires and show some partner influence is common in removal decision making. Barriers include lack of available qualified providers and supplies. Provider interactions play an important role in satisfaction with removal services.
Conclusion
Participants’ experiences accessing removal services were generally positive. Areas of potential improvement include client flow, counseling messages at insertion, and when advising clients to keep their method, pricing, and post-removal reinsertion or method switching.

Cross Sectional Study on Knowledge and Awareness on Informed Consent Among Nurses in Tertiary Care Hospital Hyderabad
K Srinivasulu, Sannidhi Ramyasri, Thamba Pranavi, KB Ronitha Vasuki Devi, Fathima Ashraf
Indian Journal of Forensic Medicine and Toxicology, October-December 2022; 16(4)
Open Access
Abstract
Nurses have a legal duty to ensure and obtain informed consent from their patients before undertaking any examination or procedure. Informed consent allows patients to make their decisions with their healthcare providers, this collaborative decision making process is mandatory in medical practice. A cross sectional study on knowledge and awareness on informed consent among nurses working in a tertiary care teaching hospital was conducted at Hyderabad, Telangana, 200 nurses working in various departments of the hospital were participated in this study, a questionnaire was prepared in regard to informed consent and assessed their knowledge levels by grading. The data was taken into Excel sheet and statistic evaluation was done by using MS Excel software. We found 67.7% are having awareness on informed consent whereas 32.3% are unaware. Similar results were observed in studies conducted in India and abroad, periodical workshops and continuous medical education programs can achieve better results.

Factor Analysis of Incomplete Informed Consent in Medical Record Installation Bangil Hospital in 2021
Mahbubah, Arma Roosalina, Holipah Holipah
Jurnal Kedokteran Brawijaya, 24 October 2022
Open Access
Abstract
Medical action is an action taken on a patient in the form of diagnostic or therapeutic. All medical procedures to be performed on the patient must in consent. To conduct an informed consent filling, is when the patient agrees to be used as a medical action after being given an explanation by the officer. The one whose in charges to take a medical action must be a medical personnel. According to the hospitals’ standard minimum services, the completeness informed consent filling must be 100%. Bangil Hospital achieved 37% of completeness informed consent filling. This study aims to analyze the causative factors of informed consent incompleteness at Bangil Hospital. This study using a descriptive data analysis. Data collection techniques in this study are using a document studies, interviews and FGD. Document studies were conducted on 100 informed consent documents, interviews and FGDs were conducted to related officers to determine the causative factors of informed consent incompleteness documents which were analyzed using fishbone diagrams. From the results of the analysis, were determined that the priority of the root of the problem to be solved first are the man factor and the method. Thus, The CARL method used to find out an alternative solutions to cope the priority of the root of the problem. From the results of the scoring conducted, the main factor of informed consent incompleteness at Bangil Hospital was due to the absence of a flow in filling out the informed consent. Keywords: Informed consent, medical action, incompleteness.

Editor’s note: Jurnal Kedokteran Brawijaya is published by the Faculty of Medicine at Universitas Brawijaya, Indonesia.

Evaluation of consent forms for clinical practice in Spanish Public Hospitals
Original Article
Morales-Valdivia, R. Camacho-Bejarano, A.M. Brady, M.I. Mariscal-Crespo
Journal of Healthcare Quality Research, 27 September 2022
Abstract
Objective
To evaluate the access, development, and quality of consents forms for clinical practice within the Spanish Public Hospitals.
Method
A cross-sectional study was conducted in a two-stage process (January 2018–September 2021). In stage 1, A nationwide survey was undertaken across all public general hospitals (n = 223) in the Spanish Healthcare System. In stage 2, Data was taken from the regional health services websites and Spanish regulations. Health Regional Departments were contacted to verify the accuracy of the findings. Data was analyzed using a descriptive and inferential statistics (frequencies, percentages, Chi-square & Fisher’s exact tests).
Results
The response rate was 123 (55.16%) of Spanish Public Hospitals. The results revealed a range of hospital departments involved in the development of consent documents and the absence of a standardized approach to consent forms nationally. Consent audits are undertaken in 43.09% hospitals and translation of written consents into other languages is limited to a minority of hospitals (35.77%). The validation process of consent documentation is not in evidence in 13% of Spanish Hospitals. Regional Informed Consent Committees are not place in the majority (70.7%) of hospitals. Citizens can freely access to consent documents through the regional websites of Andalusia and Valencia only.
Conclusion
Variability is found on access, development and quality of written consent across the Spanish Public Hospitals. This points to the need for a national informed consent strategy to establish policy, standards and an effective quality control system. National audits at regular intervals are necessary to improve the consistency and compliance of consent practice.

Development and validation of informed consent for blood transfusion questionnaire
Original Article
Mohd Hilmi Senin, Mastura Mohd Sopian, Bakiah Shaharuddin, Muhammad Jaffri Mohd Nasir
Asian Journal of Transfusion Science, 2022
Abstract
Introduction
Blood transfusion warrants written informed consent from the patient. However, patients have poor knowledge regarding blood transfusions as evidenced by nonstandardized information retained by patients from the informed consent discussion. The problem stems from suboptimal patient knowledge on the elements of informed consent. This study describes the development and validation of a new questionnaire to assess the knowledge on informed consent for blood transfusion from the patients’ perspective.
Subjects and Methods
The development phase consisted of literature review, small group discussion, expert review meeting, content, and face validity. We evaluated the psychometric properties of Informed Consent for Blood Transfusion Questionnaire (ICBTQ) using reliability test and item response theory among a sample of 95 patients in Hospital Universiti Sains Malaysia.
Results
ICBTQ was formulated to include sociodemographic and knowledge sections. ICBTQ possessed excellent content validity. The face validity index (FVI) of clarity and comprehension were both 0.97. Thus, the universal FVI was 0.96. One item was added following the advice given by one of the content experts. ICBTQ had excellent face validity. For the validation phase, ICBTQ demonstrated an acceptable Cronbach’s Alpha value. One item was omitted in view of low corrected item-total correlation. In the item response theory (IRT) analysis, ICBTQ exhibited good difficulty and discriminatory indexes. Assessments of item-fit indicated that all items of the model were well-fitted.
Conclusions
Based on the IRT and reliability analysis, the knowledge section of the ICBTQ was psychometrically valid to be used among patients.

Evaluate the practice of preoperative informed consent for elective surgical patients at the university hospital, Ethiopia, in 2022
Misganaw Terefe Molla, Yosef Belay Bizuneh, Yonas Addisu Nigatu, Debas Yaregal Melesse
International Journal of Surgery Open, 15 September 2022
Abstract
Background
Obtaining preoperative informed consent is considered an integral part of modern clinical practice. It works as a safeguard of the patient’s rights and minimizes the chances of legal action against the surgical team members. This study was to evaluate the practice of informed consent in patients undergoing elective surgery.
Methods
The study was approved by the ethical committee of the school of medicine. The patients were reassured about the anonymity of their information. A study was conducted at different surgical departments of a teaching university hospital for one month. Participants were selected based on consecutive sampling from patients over the age of 18 years who had undergone elective surgery.
Results
The overall adherence of our study to standard guidelines was 48.5%. During informed consent, 51% of patients were informed about their current condition; 49% of patients were informed about the nature and purpose of the proposed surgery; and 25% of patients were informed about the estimated duration of surgery and anesthesia.
Conclusion and recommendation
The overall adherence of our study to standard guidelines was 48.5%. The quality of the makeshift informed consent process in this study is less than the standards. There is a great need to educate the surgical team members regarding the importance of patients’ autonomy and their right to information about the proposed surgical procedure and anesthesia.

Ethically acceptable consent approaches to adolescent research in South Africa
Marian Loveday, Ameena Goga, Ames Dhai, Melodie Labuschaigne, Theresa Roussouw, Theresa Burgess, Ann Strode, Melissa Wallace, Marc Blockman, Brodie Daniels, Elizabeth Spooner, Linda-Gail Bekker
Southern African Journal of HIV Medicine, 5 September 2022
Open Access
Abstract
Background
Adolescents are a unique population with significant unmet health needs. They are often excluded from research that may benefit them as they are perceived as vulnerable and needing protection from research participation. For Research Ethics Committees, conflicting positions in statutes, regulations and ethical guidelines about who provides informed consent for adolescent involvement in health research can be a significant barrier to approving adolescent research. For researchers, the requirement for parental/guardian proxy consent or prolonged approval processes may potentially result in the exclusion of those adolescents most vulnerable and at risk, particularly if issues such as gender-based violence, gender identity, sexuality and sexual practices are in question.
Objectives
To describe the challenges to adolescent research and suggest strategies to address these.
Method
We consider the legal and ethical framework in South Africa regarding the consenting age for adolescents in research, outline the challenges and, using examples of best practices, suggest strategies to address the current conundrum.
Results
We suggest three principles to guide Research Ethics Committees on their approach to reviewing health research involving adolescents. Strategies to develop ethically acceptable approaches to adolescent research and consent processes are described, which include community involvement. We elaborate on examples of nuanced approaches to adolescent research.
Conclusion
The inclusion of adolescents in research is critical in informing appropriate and effective health services for this vulnerable population, whilst providing an opportunity to link them into care and services where relevant.

The Convolutions of the Concept of Age of Consent amongst Primary School Teachers in Zimbabwe
Agnes Pakombwele, Kwashirai Zvokuomba
International Journal of Educational Development in Africa, 30 August 2022; 7(1)
Abstract
The world over the age of consent is used as a child empowerment and protective tool. It has been argued that the age of consent supports teenagers as they negotiate the most profound aspect of childhood transition into adulthood. During this period, children and teenagers face abuse, bodily violence and exploitation. The study sought to analyse the perceptions and views of primary school teachers about age of consent within the educational setting. The study was guided by the interpretivist philosophy and was methodologically underpinned by the qualitative research design, particularly regarding data, which was collected utilising in-depth interviews and focus group discussions to solicit research participants’ opinions, feelings, and thoughts that represent their world views. The study established that teachers had little knowledge about the age of consent due to misrepresentation in the legal frameworks and inconsistencies in the law on the matter.  In addition, customary, cultural, and religious practices remain “blind” in the way they approach children’s rights issues. Thus, the article advocates for a child-centred framework when dealing with issues that affect the well-being of children as a way of demystifying the age of consent in the educational sector, which should also be informative not only to teachers but traditional leaders and legal practitioners so as to have a shared understanding of the concept.  It is recommended that the age of consent should be the same for both boys and girls just as the age of majority, which is at 18 years.

Informed Consent to Online Standard Form Agreements
Rob Nicholls
Global Privacy Law Review, 2022; 3(3) pp 163-176
Abstract
This article examines the issues associated with online consent to ‘take it or leave it’ contracts, also known as standard form agreements. It does this by describing the concepts of standard form agreement and their deviations from bilateral contracts. It also sets out the meaning of informed consent. With these concepts established, the article analyses informed consent in online standard form agreements and provides an analysis of the factors impacting informed consent. The article also draws a distinction between unfairness and unconscionability. The article demonstrates that courts and regulators look the other way when it comes to recognizing substantive unfairness and unconscionability in online standard form agreements. It discusses the legal, economic, behavioural and social dynamics of informed consent in the context of the Australian marketplace. The article demonstrates that, in Australia, the focus on procedural unfairness and procedural unconscionability as threshold requirements have prevented the notion of informed consent from voiding particular terms. That is, as long as there was notice and an opportunity to read, in Australia the actual content of the terms seems to have limited importance.