Informed Consent in Dental Practice: A Qualitative Analysis of Awareness and Apprehensions Among Practitioners in South India
Dr Baiju R M, Dr Elbe Peter, Dr Vivek Narayan, Dr Roshna E K, Dr Abhilash Babu, Dr Nandimath Omprakash V
International Journal of Social Science And Human Research, 2 February 2023; 6(2)
Open Access
Abstract
Context
The push for autonomy and liberalization has transformed the practice of medicine and dentistry from paternalism to a patient cantered model. Patient’s choice to accept or reject the proposed treatment is central to this new paradigm of health care. Informed consent is an essential tool for an ethical dental practice.
Aim
The objective of the present study was to explore the knowledge, attitudes, perceptions and prevailing practices among dentists regarding the informed consent process.
Materials and methods
A phenomenological approach was undertaken. A semi structured telephonic interview was conducted based on a flexible topic guide and continued until data saturation.
Statistical analysis
The data was transcribed verbatim. Coding and categorisation done. Anonymity was ensured in all steps. The data was subjected to a thematic analysis.
Results
Participants were apprehensive about the influence of social media on the new paradigm of doctor patient relationship and the increasing utility of specialists as a protection from litigation. Lack of clarity regarding the consent method has prevented its routine application.
Conclusions
It can be concluded that a comprehensive understanding regarding informed consent process was lacking among the participants.

Iranian women’s experiences of the episiotomy consent process: a qualitative study
Malihe Ghiasvand, Fatemeh Nahidi, Sedigheh Sedigh Mobarakabadi, Hamid Alavi Majd
British Journal of Midwifery, 1 February 2023; 31(2)
Abstract
Background
Knowledge of the benefits and complications of interventions related to medical procedures, such as episiotomy, enables women to make informed decisions regarding these interventions. This study investigated women’s experiences of the episiotomy consent process in Iran.
Methods
This qualitative study gathered data from 20 women through in-depth semi-structured interviews. The participants were selected from hospitals, health centers and gynecology clinics in Tehran. Content analysis was used to establish themes from the gathered data.
Results
The participants’ experiences showed that they felt that their needs were not met and that they were excluded from decision making regarding their birth.
Conclusions
Women were excluded from decision making and their unmet needs presented ethical challenges in the performance of episiotomy procedures. Neglecting women’s expectations, inducing absolute trust in obstetricians or midwives and failing to obtain informed consent paved the way for forced episiotomies. Proper education and obtaining informed and voluntary consent may facilitate women’s rights being respected.

Awareness of Post-Operative Patients Regarding Informed Consent Form in Public Tertiary Care Hospital of Peshawar Khyber Pakhtunkhwa: A Cross Sectional Survey
Original Article
Bakhtyar Ali Shah, Muhammad Anwar, Nusrat Begum, Naheed Akhtar, Amir Sultan, Muzamil Tariq, Sumaira Bibi
Pakistan Journal Of Health Sciences, 31 January 2023
Open Access
Abstract
The informed consent form is one of the components of bioethics. Written consent from the patient must be obtained prior to any medical or surgical procedure to give the patient freedom of choice. This factor has always been neglected when caring for patients in most third world countries.
Objective
To assess postoperative patient awareness of informed consent at Peshawar KP Tertiary Public Hospital (HMC).
Methods
This study was conducted from April 2021 to August 2021 at Hayatabad Medical Complex, a tertiary care public hospital in Peshawar. A total sample of 70 patients was drawn by consecutive selection. An adopted and pre-tested questionnaire was used for data collection. Questions were filled in by having the patient understand the question and receiving the answer from the patient.
Results
The majority (59%) of the patients included in this study were male, while the mean age was 35 years and the majority of the patients (44%) were illiterate. Awareness of variables (2–7) was 60%, 47%, 30%, 47%, 69%, and 53%, respectively, while awareness levels from questions 8–12 were 59%, 47%, 82%, 40%, and 60%, respectively.
Conclusions
The results of the current study indicate that the perception of informed consent among patients in tertiary care public hospitals is reasonably satisfactory, although some lack of participant knowledge of key issues has been identified and needs to be improved through education and awareness.

Consent and Complications in Health Care: The Italian Context
Review
Maricla Marrone, Enrica Macorano, Giuseppe Lippolis, Pierluigi Caricato, Gerardo Cazzato,
Antonio Oliva, Benedetta Pia De Luca
Healthcare, 27 January 2023
Open Access
Abstract
Informed consent is the manifestation of the will that a patient freely expresses toward a medical treatment. The physician is responsible for acquiring informed consent for both medical and nursing procedures. Informed consent represents a juridical–deontological tool that allows therapeutic choices to be shared with the user after having exhaustively explained the risks and benefits of the procedure itself. In fact, the physician has an obligation to provide the patient with clear and comprehensible information about the type of service, the methods of delivery, the benefits, the risks, even unforeseeable ones, and the complications. According to Italian legal guidelines, in cases of presumed health responsibility, the health professional accused of negligence will have to demonstrate that any complication that has arisen, although foreseeable, was not preventable. Through the analysis of a clinical case relating to the procedure of insertion of a bladder catheter performed by a nurse and a review of the literature, the authors explain the importance of the information that must be provided to the patient before carrying out any invasive procedure, even if not performed by the doctor. The authors describe the problem in the Italian context and propose a possible solution.

Formal Quality and Compliance of Informed Consent Forms in Critical Care and Surgical Areas in Spain: An Observational Study
José Manuel García-Álvarez, José Luis Díaz-Agea, María Suárez-Cortés, Alonso Molina-Rodríguez, Ismael Jiménez-Ruiz, Alfonso García-Sánchez
Nursing Reports, 31 December 2022; 13(1) pp 43-50
Open Access
Abstract
Background
The informed consent form must contain all the relevant information about the procedure to be performed to guarantee the patient’s freedom to choose.
Objective
To analyze the formal quality of, and compliance with informed consent forms in critical care and surgical areas in a county hospital in Spain.
Methods
The formal quality of informed consent forms in critical care and surgical areas from the hospital were analyzed, following the established formal quality criteria for informed consent forms. The compliance with specific criteria for each of the operated patients during the period of study was also evaluated.
Results
The formal quality of 224 informed consent forms was analyzed from 8 disciplines observing a median of non-compliances of 4 with a minimum of 1 and a maximum of 5, with the most breaches being in verifying the delivery of a copy to the patient and showing contraindications. The compliance of 376 documents from 188 operated patients were assessed, highlighting that the non-complied items were: the personalized risks and complete identification of the patient and the physician. A significant association was found between disciplines analyzed and the identification of the physician and personalized risks, with anesthesia and critical care showing the best compliance.
Conclusions
The informed consent forms in critical care and surgical areas were shown to have a deficient formal quality and an inadequate compliance. These deficiencies should be corrected to improve the information received by the patients and to guarantee their freedom to choose. As nurses have a responsibility to ensure that patients are adequately informed about both nursing interventions and care, as well as the surgical treatments they receive, consideration should be given to the possibility of nursing professionals taking the lead in obtaining informed consent.

A comprehensive analysis of the readability of consent forms for blood transfusion in Spain
Morales-Valdivia E, Brady AM, Mariscal-Crespo MI, Camacho-Bejarano R
Blood Transfusion, 22 December 2022
Abstract
Background
This study aimed to evaluate the readability of consent forms for blood transfusion in public hospitals in Spain.
Materials and methods
This was a cross-sectional, national study conducted within the Spanish healthcare system. Data were collected through the online retrieval of consent documents and direct consultation with 223 public hospitals. Consent forms were subjected to readability assessment including typographical, grammatical and lexical dimensions. The INFLESZ scale, a well-validated instrument adapted to the reading habits of Spaniards, was applied to determine the grammatical readability of the documents. The Spanish Mosby’s Dictionary and the Dictionary of Spanish were used together to systematically identify the number of medical terms contained in the text. Data were analyzed using descriptive and inferential statistics.
Results
Forty-five written consent forms for blood transfusion, in use in 126 general public hospitals were evaluated for various parameters, including font size (=10.41), abbreviations (=10.58), word count (=595, 209 min-1,499 max) and length (1 to 7 pages). The overall readability score (=50.66) was indicative that consent forms are somewhat difficult to read. A heterogeneity of 116 different healthcare terminology words was identified. Word count was statistically and moderately positively related to the number of medical terms identified in the text (rho=0.496, p=0.001) and the INFLESZ score (rho=0.34, p=0.023).
Discussion
In this first national study to assess the ease of reading written information on blood transfusion given to patients, deficiencies were found in the three dimensions of readability (typographical, grammatical and lexical) and a lack of uniformity among the written consent forms is pronounced. Further research is needed to develop more person-centered tools to support patients in the process of consenting for blood transfusion.

Remote consent approaches for mobile phone surveys of non-communicable disease risk factors in Colombia and Uganda: A randomized study
Research Article
Joseph Ali, Madhuram Nagarajan, Erisa S. Mwaka, Elizeus Rutebemberwa, Andres I. Vecino-Ortiz, Angelica Tórres Quintero, Mariana Rodriguez-Patarroyo, Vidhi Maniar, Gulam Muhammed Al Kibria, Alain B. Labrique, George W. Pariyo, Dustin G. Gibson
PLOS ONE, 21 December 2022
Open Access
Abstract
Introduction
Automated mobile phone surveys (MPS) can be used to collect public health data of various types to inform health policy and programs globally. One challenge in administering MPS is identification of an appropriate and effective participant consent process. This study investigated the impact of different survey consent approaches on participant disposition (response characteristics and understanding of the purpose of the survey) within the context of an MPS that measured noncommunicable disease (NCD) risk factors across Colombia and Uganda.
Methods
Participants were randomized to one of five consent approaches, with consent modules varying by the consent disclosure and mode of authorization. The control arm consisted of a standard consent disclosure and a combined opt-in/opt-out mode of authorization. The other four arms consist of a modified consent disclosure and one of four different forms of authorization (i.e., opt-in, opt-out, combined opt-in/opt-out, or implied). Data related to respondent disposition and respondent understanding of the survey purpose were analyzed.
Results
Among 1889 completed surveys in Colombia, differences in contact, response, refusal, and cooperation rates by study arms were found. About 68% of respondents correctly identified the survey purpose, with no significant difference by study arm. Participants reporting higher levels of education and urban residency were more likely to identify the purpose correctly. Participants were also more likely to accurately identify the survey purpose after completing several survey modules, compared to immediately following the consent disclosure (78.8% vs 54.2% correct, p<0.001). In Uganda, 1890 completed surveys were collected. Though there were differences in contact, refusal, and cooperation rates by study arm, response rates were similar across arms. About 37% of respondents identified the survey purpose correctly, with no difference by arm. Those with higher levels of education and who completed the survey in English were able to more accurately identify the survey purpose. Again, participants were more likely to accurately identify the purpose of the survey after completing several NCD modules, compared to immediately following the consent module (42.0% vs 32.2% correct, p = 0.013).
Conclusion
This study contributes to the limited available evidence regarding consent procedures for automated MPS. Future studies should develop and trial additional interventions to enhance consent for automated public health surveys, and measure other dimensions of participant engagement and understanding.