Educate Before You Operate: Improving the Informed Consent Process
Brian Piatkowski, Jeanne Lee, Eli Strait
Journal of Burn Care & Research, 15 May 2023
Abstract
Introduction
The informed consent process is a daily task for providers with a surgical patient population. In the burn population, informed consent is often presented by an intern or resident physician. Consent is comprised of surgical debridement with a multitude of options for coverage of their wounds. The current state of practice is a verbal overview of all the possible procedures that may be done to the patient’s wound(s). Patients often verbalize feeling overwhelmed with the amount of information on the consent and often have questions related to their procedure just before the brief of the operative case.
Methods
An educational video was developed that detailed the surgical procedure and the potential burn wound coverings. A 3-question survey was given to patients who have already been through the informed consent process. Survey metrics examined knowledge of consent when signed, the satisfaction of verbal explanation, and if a video would increase understanding. The video was given to the same patients to watch. After the video was viewed, those patients were then again surveyed. Providers were also given a 3-question survey before viewing the video. Survey metrics examined comfort of consent, knowledge of procedures, and if the video would increase patient understanding of consent topics. The providers were then surveyed after watching the video.
Results
Initial post-implementation data shows that patients and providers have increased comfort and knowledge in the informed consent process. Patients show an 80% increase in understanding of consent, a 72% increase in satisfaction with video vs verbal overview, and a 97% increase in satisfaction with material viewed. Provider data shows a 65% increase in the comfort of consent, a 64% increase in knowledge of procedures, and a 97% increase that the video will help patients understand their consent. This shows that this evidence-based project is an improvement from the current standard of practice.
Conclusions
The informed consent process is an opportunity for providers and patients to have a moment of discussion. It is a pivotal point in which a patient and a provider determine the next step of their care. The patient must have clear communication and education regarding the procedures to which they are consenting. It is also a discussion where a provider can provide education and support at what is an overwhelming time for patients in their hospital stay.
Applicability of Research to Practice
Implementation of a standardized audio/video teaching method for burn surgical patients is an effective way to increase patient and provider satisfaction regarding the informed consent process. Implementing this educational tool is a cost-effective and simple way to educate burn patients before their surgical procedures. There is an overall improvement in patient satisfaction and increased satisfaction in the providers who obtain the consent.
Alternative Means of Informed Consent in Cardiology: Strategies and Effectiveness in a Group of Italian Patients
Alternative Means of Informed Consent in Cardiology: Strategies and Effectiveness in a Group of Italian Patients
Ines Testoni, Lucia Ronconi, Francesca Lampis, Erika Iacona, Josephine Zammarrelli, Sara Pompele, Roberto Valle, Gabriele Boscolo, Diego De Leo
Behavioral Sciences, 19 May 2023
Open Access
Abstract
Informed consent practices in healthcare represent a fundamental element of patient-centred care; however, the traditional use of a written, paper-based description of the medical procedure to obtain informed consent presents many limitations. This research aimed to evaluate the effects of an alternative modality of obtaining informed consent using a brief informative video for patients waiting to undergo a coronary angiography procedure in Italy. The study involved 40 participants—28 males and 12 females (mean age: 68.55, SD = 13.03)—divided equally into two groups: one group received the video-based informed consent and the other received a traditional paper-based form. Each group was asked to fill in two questionnaires; one was created by the researchers to measure the patient’s level of understanding of the given information and the perception of usefulness of the informed consent, and the other was the Depression Anxiety Stress Scales-21 (DASS-21), which evaluates levels of anxiety, depression and stress. A comparison of the results of the two groups showed that videobased informed consent allowed participants to better understand the given information, to feel more confident concerning their subjective comprehension of it and to perceive the video-based informed consent as more useful than the traditional one. The video-based informed consent did not lead to higher levels of anxiety, depression or stress among the participants. It can be hypothesized that video-based formats may represent a more useful, understandable and safe alternative to traditional paper-based informed consent in healthcare.
Editor’s note: The editors recognize the need for further research in this area before conclusions can be drawn.
Implementation in Midwifery Services: A Description Study
Implementation in Midwifery Services: A Description Study
Nina Zuhana, Eka Budiarto, Lia Dwi Prafitri, Rini Kristiyanti
Advances in Social Science, Education and Humanities Research, May 2023
Abstract
Midwifery services must be provided by midwives by implementing legal ethics in midwifery. This ethics can be fulfilled by giving informed consent before performing midwifery services. Informed consent is obtained by giving information about the midwifery services that will be provided to the patient and asking the patient to sign the midwifery service agreement sheet indicating that the patient is willing to receive the provided midwifery information and services as well as all the possible consequences. Informed consent is required when midwives provide care for pregnancy, childbirth, postpartum, and newborns. The objective of this study was to identify the implementation of informed consent by midwives in providing midwifery services in health care facilities such as hospitals, health centers, and autonomous midwifery practices. This research was a descriptive study with a cross-sectional approach involving 71 midwives in Pekalongan Regency. It was carried out in March 2021 by distributing questionnaires to the participating midwives who were selected through a quota sampling method. The collected data were analyzed by using central tendency and frequency distribution. The results of data analysis showed that the average age of the participants was 36.5 years old, the average length of work was 12.8 years, and the education level of the majority of them was diploma three (69%). A total of 70.4% of the midwives obtained informed consent before providing midwifery services. This number indicates that there were midwifery services that had not implemented ethical and legal aspects. The ethical and legal noncompliance cases in midwifery services might increase if no effort to achieve 100% informed consent implementation was taken. Therefore, regulation that manage and bind midwives in carrying out informed consent to achieve 100% implementation of it in midwifery services is needed.
Editor’s note: The midwives in this article are practicing in Indonesia.
Status of Informed Consent in Surgical Patients in Hospitals of Sindh Pakistan
Status of Informed Consent in Surgical Patients in Hospitals of Sindh Pakistan
Tariq Abdullah, Muhammad Akbar, Shahnawaz Khatti, Ishrat Rahim Katyar, Karim Bux, Muhammad Anwar
Pakistan Journal of Medical & Health Sciences, March 2023
Abstract
Background
Informed consent (IC) is a critical step in ensuring that patients understand implications of their treatment decisions.
Materials and Methods
It is observational cross-sectional study. Non probability purposive sampling was used to collect data from different surgical units. Adult postsurgical patients were questioned using a standardized questionnaire between the first- and fifth-day following surgery in two general hospitals in Sindh province (Hyderabad and Jamshoro). Data was analyzed using SPSS and Microsoft excel.
Results
A total of 78% of individuals who claimed to have read it found informed consent to be easy to understand. Less than half of patients thought information brought them some emotional solace, while 23.2% of patients reported feeling more anxious after hearing information. This study suggests enhancing the process of obtaining consent forms by including additional information and avenues for discussion on written documents rather than relying solely on verbal communication.
Conclusion
Patients under age of sixty and patients who had completed more schooling tended to read written informed consent forms more frequently. Orally communicated pre-operative information suited patients’ requirements better than written informed consent. Surgeon needs to get informed permission from patient and inform them about operation type, potential consequences and other treatment options.
Patient choice: the shape of consent post-Montgomery
Patient choice: the shape of consent post-Montgomery
Shaun Sellars, Lauren Sutherland
British Dental Journal, 12 May 2023; 234, pp 655 – 659
Abstract
The law relating to consent and the process dentists need to go through to gain valid and informed consent to treat patients changed significantly following the landmark ruling of Montgomery v Lanarkshire Health Board. In this paper, we revisit the history of patient consent, give an update on the current legal situation in the UK, and produce a unique ‘consent workflow’ to aid in the process of gaining valid and informed consent to treat. The aim is to clarify the legal standing and provide a framework that dentists and other healthcare professionals can adapt to their current clinical practice while increasing the confidence of those involved in the consent process; both professionals and patients.
Disclosing Privacy and Discrimination Protections in Informed Consent
Disclosing Privacy and Discrimination Protections in Informed Consent
Anya E.R. Prince
Health Matrix: The Journal of Law – Medicine, May 2023; 33(1)
Open Access
Abstract
Recent empirical work shows that providing greater detail about limitations of genetic anti discrimination protections in informed consent documents is likely to lower individuals’ willingness to participate in research studies. This article presents these empirical findings and analyzes the implications of the findings for clinical care and for privacy and discrimination risks beyond genetic discrimination. While the paper argues that further research is needed to fully understand the potential implications of disclosure of legal protections in the clinical setting, there are clear implications in the research setting. Since individuals are likely to alter their decision to participate in research based on the depth of information provided, informed consent should contain detailed information about privacy and discrimination risks. However, for participants to truly understand the risk of loss of privacy and potential for discrimination that flows from information disclosures in research, they arguably must have a robust understanding of both when and how information may be shared, but also the legal protections and limitations that govern use of that data. Now, more than ever, it is essential to understand the privacy risks associated with joining a study since research trends related to big data and secondary research are vastly increasing the privacy risks for participants. Yet, while it is easy to state that individuals should be told of both privacy and anti-discrimination laws and their respective limitations, disclosing these in practice is much more complex. For every law, there are countless limitations that could be enumerated, but such disclosures would quickly make informed consent unwieldy and counterproductive. Thus, this paper argues that institutional review boards (“IRBs”) can help to find a limiting principle to the disclosures by assessing the likelihood of harm and contextualizing the risks to the study population. This will balance between over- and under-disclosure of legal protections and limitations while still fulfilling important foundational goals of informed consent.
Organ and Tissue Donation Consent Model and Intent to Donate Registries: Recommendations From an International Consensus Forum
Organ and Tissue Donation Consent Model and Intent to Donate Registries: Recommendations From an International Consensus Forum
Phil Walton, Alicia Pérez-Blanco, Stephen Beed, Alexandra Glazier, Daniela Ferreira Salomao Pontes, Jennifer Kingdon, Kim Jordison, Matthew J. Weiss
Transplant Direct, 23 April 2023; 9(5)
Open Access
Abstract
Background
Consent model and intent to donate registries are often the most public facing aspects of an organ and tissue donation and transplantation (OTDT) system. This article describes the output of an international consensus forum designed to give guidance to stakeholders considering reform of these aspects of their system.
Methods
This Forum was initiated by Transplant Québec and cohosted by the Canadian Donation and Transplantation Program partnered with multiple national and international donation and transplantation organizations. This article describes the output of the consent and registries domain working group, which is 1 of 7 domains from this Forum. The domain working group members included administrative, clinical, and academic experts in deceased donation consent models in addition to 2 patient, family, and donor partners. Topic identification and recommendation consensus was completed over a series of virtual meetings from March to September 2021. Consensus was achieved by applying the nominal group technique informed by literature reviews performed by working group members.
Results
Eleven recommendations were generated and divided into 3 topic groupings: consent model, intent to donate registry structure, and consent model change management. The recommendations emphasized the need to adapt all 3 elements to the legal, societal, and economic realities of the jurisdiction of the OTDT system. The recommendations stress the importance of consistency within the system to ensure that societal values such as autonomy and social cohesion are applied through all levels of the consent process.
Conclusions
We did not recommend one consent model as universally superior to others, although considerations of factors that contribute to the successful deployment of consent models were discussed in detail. We also include recommendations on how to navigate changes in the consent model in a way that preserves an OTDT system’s most valuable resource: public trust.
Completion of the informed consent in radioguided surgery by the General Surgery and Nuclear Medicine services of a radioguided surgery unit
Completion of the informed consent in radioguided surgery by the General Surgery and Nuclear Medicine services of a radioguided surgery unit
Original Article
Jiménez-Granero, J.I. Rayo-Madrid, J.R. Infante-de-la-Torre, J. Serrano-Vicente, A. Martínez-Esteve, A. Baena-García, A. Utrera-Costero, R. Juárez-Vela
Revista Española de Medicina Nuclear e Imagen Molecular, 16 May 2023
Abstract
Objective
To identify the frequency of errors in informed consent documents in radioguided surgery in a third level hospital and to detect possible causes or factors associated with a greater risk of error.
Material and methods
Informed consent forms of a total of 369 radioguided surgery interventions, completed by the Nuclear Medicine and General Surgery services, were analyzed, and the degree of completion of the forms and its correlation with the physicians responsible, type of pathology, intervention, and waiting time were compared with the completion of consent by another specialty.
Results
Errors were identified in 22 consent forms from Nuclear Medicine and 71 from General Surgery. The most common error was the absence of identification of the physician responsible (17 in Nuclear Medicine, 51 in General Surgery), and the second most common was the absence of a document (2 in Nuclear Medicine, 20 in General Surgery). There were significant differences in the errors made depending on the doctor in charge, with no significant correlation with the other variables.
Conclusions
The physicians responsible were the main factor associated with a greater risk of error in the completion of informed consent forms. Further studies are needed to analyze the causal factors and possible interventions to minimize errors.
Identifying which adverse events associated with dry needling should be included for informed consent: A modified e-Delphi study
Identifying which adverse events associated with dry needling should be included for informed consent: A modified e-Delphi study
Research Report
Edmund C Ickert, David Griswold, Ken Learman, Chad Cook
Physiotherapy Theory and Practice, 9 May 2023
Abstract
Objective
Dry needling (DN) uses a monofilament needle to reduce pain and is performed by various healthcare professions. Due to the invasive needle puncture, adverse events (AEs) have been associated with DN. It is unclear, which AEs should be included in a risk statement for Informed Consent (IC). The purpose of this study was to identify which AEs should be included in a risk statement for IC.
Methods
A three-round e-Delphi study was undertaken using a panel of DN experts. Expert inclusion criteria included: (1) ≥5 years practice performing DN and one of the following secondary criteria: (A) certification in DN; (B) completion of a manual therapy fellowship that included DN training; or (C) ≥1 publication involving the use of DN. Participants rated their level of agreement using a 4-point Likert scale. Consensus was defined as either: 1) ≥80% agreement; or 2) ≥70% and <80% agreement with median ≥3, interquartile range ≤1, and standard deviation ≤1.
Results
A total of 14 (28%) AEs achieved final consensus in Round 3 for inclusion on IC. Kendall’s Coefficient 
of agreement for Round 2 was 0.213 and improved to 0.349 after Round 3. Wilcoxon rank tests revealed statistically significant changes for 12 of the 50 AEs.
Conclusion
Consensus was attained for 14 AEs for inclusion on IC. The AEs identified can be used for the development of a shorter, more concise IC risk statement. A total of 93.6% of experts agreed on definitions for AE classification.
‘First ensure no regret’: a decision-theoretic approach to informed consent in clinical practice
‘First ensure no regret’: a decision-theoretic approach to informed consent in clinical practice
Short report
Narcyz Ghinea
Journal of Medical Ethics, 8 May 2023
Abstract
Decision theorists recognise that information is valuable only insofar as it has the potential to change a decision. This means that since acquiring more information is time-consuming and sometimes expensive, judgements need to be made about what information is most valuable to acquire, and whether it is worth acquiring at all. In this article I apply this idea to informed consent and argue that the most valuable information relates not to what the best treatment option may be but to possible futures a patient may regret. I conclude by proposing a regret-minimisation framework for informed consent that I contend better captures the true nature of shared decision making than existing formulations.
Center for Informed Consent Integrity 