Development of a core outcome set for informed consent for therapy: An international key stakeholder consensus study

Development of a core outcome set for informed consent for therapy: An international key stakeholder consensus study
Research
Liam J. Convie, Joshua M. Clements, Scott McCain, Jeffrey Campbell, Stephen J. Kirk, Mike Clarke
BMC Medical Ethics, 9 August 2022; 23(79)
Open Access
Abstract
Background
300 million operations and procedures are performed annually across the world, all of which require a patient’s informed consent. No standardised measure of the consent process exists in current clinical practice. We aimed to define a core outcome set for informed consent for therapy.
Methods
The core outcome set was developed in accordance with a predefined research protocol and the Core OutcoMes in Effectiveness Trials (COMET) methodology comprising systematic review, qualitative semi structured interviews, a modified Delphi process and consensus webinars to ratify outcomes for inclusion in the final core outcome set. (Registration—https://www.comet-initiative.org/Studies/Details/1024). Participants from all key stakeholder groups took part in the process, including patients and the public, healthcare practitioners and consent researchers.
Results
36 outcome domains were synthesised through systematic review and organised into a consent taxonomy. 41 semi-structured interviews were performed with all consent stakeholders groups. 164 participants from all stakeholder groups across 8 countries completed Delphi Round 1 and 125 completed Round 2. 11 outcomes met the ‘consensus in’ criteria. 6 met ‘consensus in’ all stakeholder groups and were included directly in the final core outcome set. 5 remaining outcomes meeting ‘consensus in’ were ratified over two consensus webinars. 9 core outcomes were included in the final core outcome set: Satisfaction with the quality and amount of information, Patient feeling that there was a choice, Patient feeling that the decision to consent was their own, Confidence in the decision made, Satisfaction with communication, Trust in the clinician, Patient satisfaction with the consent process, Patient rated adequacy of time and opportunity to ask questions.
Conclusion
This international mixed-methods qualitative study is the first of its kind to define a core outcome set for informed consent for intervention. It defines what outcomes are of importance to key stakeholders in the consent process and is a forward step towards standardising future consent research.

Informed Consent Practices in Global Surgery among Plastic Surgery Organizations

Informed Consent Practices in Global Surgery among Plastic Surgery Organizations
Special Topic
Kishan Thadikonda, Rosaline Zhang, Jonathan Bruhn, Phuong D. Nguyen, Samuel O. Poore
Plastic and Reconstructive Surgery, 8 August 2022
Abstract
Background
Global surgery organizations often serve vulnerable and complex patient populations, but there is limited knowledge on the protocols used to obtain informed consent for procedures and content sharing.
Methods
The Plastic Surgery Foundation Volunteers in Plastic Surgery (VIPS) database was queried for organizations actively involved in global surgery. Seventy-nine organizations received email invitations to participate in a survey study regarding their protocols for obtaining consent for procedures and sharing multimedia content.
Results
A total of 17 (22% yield) organizations completed the survey. All were active for at least 10 years and 88% (15/17) organized at least two mission trips annually. Eighty-eight percent (15/17) reported obtaining written consent for surgical procedures. Less than half (46%, 8/17) of used a written consent form that was created jointly with the local hospital. For sharing content related to global surgery experiences, 75% (12/16) obtained some form of written consent while 6% (1/16) did not routinely obtain any consent. Organizations shared content most commonly through their websites and Facebook. All organizations reported using interpreters to obtain informed consent at least some of the time. 62% (10/16) reported that they relied primarily on volunteers or community members to provide informal interpretation assistance, rather than formally trained professional interpreters.
Conclusion
Practices related to obtaining informed consent vary widely among global surgery organizations. The development of standardized protocols and guidelines will ensure that global health organizations, in collaboration with their local partners, properly obtain informed consent for procedures and sharing publicly viewable content.

Are we meeting the standards set for informed consent in spinal surgery?

Are we meeting the standards set for informed consent in spinal surgery?
Y Esemen, A Mostofi, D Richardson, EAC Pereira
Annals of Royal College of Surgeons, 29 July 2022
Abstract
Introduction
Informed consent empowers patients to exercise their autonomy and actively participate in their medical care. Guidance published by the British Association of Spine Surgeons (BASS) lists three components of consent: provision of information booklets, patient-centred dialogue and completion of appropriate consent forms. The aim of the study was to review the quality of the spinal surgery consent process against the BASS guidance in a single tertiary neurosurgery centre in London.
Methods
Retrospective review of clinic letters and consent forms was performed for 100 consecutive cases of elective, non-instrumented spinal decompression surgeries performed in 2019. Documentation was graded for inclusion of the intended benefit (improvement of pain/prevention of neurological deterioration), alternative management options (including no treatment), surgical options and risks (infection, bleeding, paralysis, sphincter disturbances, dural tear and recurrence). Provision of supplementary information booklets was recorded. Two-tailed Fisher exact test was used to calculate statistical significance where appropriate.

Results
Documentation of indications and risks of elective spinal surgery, specifically risk of recurrence (62%) and sphincter disturbance (85%), was suboptimal on the consent forms. Documentation of these risks was also poor in clinic letters (<50%). Alternative treatment options were explained in less than half of the clinic letters, and there was no documentation of information booklet provision prior to elective surgeries.
Conclusion
Lack of informed consent plays a major role in medical malpractice claims in spinal surgery. Poor documentation puts the surgeon in a liable position. BASS guidance could be implemented to create a more standardised process of consent in spinal surgery.

Informed Consent before coronary angiography and percutaneous coronary intervention from the patient’s perspective: A picture is worth a thousand words

Informed Consent before coronary angiography and percutaneous coronary intervention from the patient’s perspective: A picture is worth a thousand words
Brand, C. Crayen, A. Hamann, S. Martineck, L. Gao, H. Brand, S.M. Squier, K. Stangl, F. Kendel, V. Stangl
IJC Heart & Vasculature, August 2022; 41
Abstract
Background
Patients scheduled for coronary angiography may feel insufficiently informed about the planned procedure. We aimed to evaluate the patient-rated quality of the Informed Consent (IC) process and to investigate the efficacy of medical graphics to assist and improve the IC procedure.
Methods
A graphic-based information broschure illustrating central steps of the procedure was created in collaboration with scientific illustrators. In a randomized, controlled, prospective trial, 121 patients undergoing coronary angiography/PCI were randomized to a group obtaining the usual IC (Control group) or to a group that additionally obtained a graphic-based IC (Comic group). The perceived quality of the IC was compared between groups using single items of the Client Satisfaction Questionnaire-8 and self-designed single items.
Results
Only 67.8% of patients stated to have completely read the standard written IC sheet. The quality of the IC was perceived to be very good in 45.0% of patients in the Comic group compared to 24.6% in the Control group (p =.023). 57.4% of the Control group compared to 76.7% of the Comic group stated that all of their questions were satisfactorily adressed (p =.015). 43.3% of the Comic group, in contrast to only 18.0% of the Control group, declared to feel „very satisfied“ with the obtained IC procedure (p =.002). The acceptance of this new IC approach was very high: no patient expressed feelings of not being taken seriously when reading medical graphics.
Conclusions
Our data confirm pronounced limitations of the usual IC practice. The use of medical graphics positively impacts on patient-evaluated endpoints and may significantly improve the IC procedure.

Informed consent for suspension microlaryngoscopy: what should we tell the patient? A consensus statement of the European Laryngological Society

Informed consent for suspension microlaryngoscopy: what should we tell the patient? A consensus statement of the European Laryngological Society
Frederik G. Dikkers, Michel R. M. San Giorgi, Rico N. P. M. Rinkel, Marc Remacle, Antoine Giovanni, Małgorzata Wierzbicka, Riaz Seedat, Guillermo Campos, Guri S. Sandhu
European Archives of Oto-Rhino-Laryngology, 12 July 2022
Open Access
Abstract
Introduction
Informed consent for any surgical intervention is necessary, as only well-informed patients can actively participate in the decision-making process about their care, and better understand the likely or potential outcomes of their treatment. No consensus exists on informed consent for suspension microlaryngoscopy (SML).
Materials and methods
Informed consent procedures in nine countries on five continents were studied.
Results
Several risks can be discerned: risks of SML as procedure, anesthesiologic risks of SML, specific risks of phonosurgery, risks of inadequate glottic exposure or unexpected findings, risks of not treating. SML has recognized potential complications, that can be divided in temporary (minor) complications, and lasting (major) complications.
Conclusion
SML is a safe procedure with low morbidity, and virtually no mortality. Eleven recommendations are provided.

Patients’ satisfaction and associated factors towards preoperative informed consent process: A cross-sectional study

Patients’ satisfaction and associated factors towards preoperative informed consent process: A cross-sectional study
Tamiru Tilahun Ayele, Tadese Tamire Negash, Keder Essa oumer, Aderajew Mekuanint, Diriba Teshome, Efrem Fenta, Yewlsew Fentie, Aragaw Tesfaw Ashenafi Tolosa
Annals of Medicine and Surgery, 4 July 2022; 79
Abstract
Background
Informed consent is a process that needs time and effort to satisfy patients’ desires. Patient dissatisfaction on preoperative informed consent process may be caused by multiple factors of clinical practice. This study aimed to assess patients’ satisfaction and associated factors of informed consent process among elective surgical patients.
Methods
A cross-sectional study was conducted on 404 postoperative patients who signed the informed consent for elective surgery. A systematic sampling technique was applied to select the study participants. Modified Leiden perioperative patient satisfaction tool was adapted to assess patients’ satisfaction with preoperative informed consent process. Data were entered in to Epi-data version 4.20 and exported to SPSS version 20 for analysis. Bivariate and multivariable logistic regression was computed to identify independent variables associated with patient satisfaction towards preoperative informed consent process. A p-value of less than 0.05 was used to declare the statistical significance.
Results
The overall satisfaction of patients with preoperative informed consent process was 70.3%. Multivariable logistic regression analysis revealed that, being male (AOR: 4.75, 95% CI: 2.47–9.16), primary school (AOR: 8.42, 95% CI: 4.74–7.55), secondary school (AOR: 2.17, 95% CI: 5.74–8.62), rural residence (AOR: 1.8, 95% CI: 2.1–3.9) and received general anesthesia (AOR: 2.92, 95% CI: 1.62–5.26) were significantly associated with patients’ satisfaction with the informed consent process.
Conclusion
The overall patients’ satisfaction on preoperative informed consent process was relatively low. Being male, low level of education, living in rural area, and receiving general anesthesia were significantly associated with patients’ satisfaction on informed consent process. Surgeons and anesthesia professionals need to work more to improving the satisfaction of patients with preoperative informed consent process. Researchers are expected to do periodic assessment of patients’ level of satisfaction and factors affecting satisfaction.

Transplant donor consent and dual roles: A case study in ethical dilemmas

Transplant donor consent and dual roles: A case study in ethical dilemmas
Original Article
Gassas
Ethics, Medicine and Public Health, August 2022; 23
Abstract
Summary
Background
This case study describes the ethical dilemma encountered by a Bone Marrow Transplant (BMT) coordinator upon withdrawal of a donor’s consent. The case points to the pressure on the coordinator to advocate simultaneously for donor and patient, which results in conflict between the coordinator’s dual roles.
Objectives
The aim of this case study is to uncover neglected facts about ethical dilemmas concerning patient donors and transplant coordinators in Saudi Arabian settings.
Methods
This paper was developed from a case study involving the ethical issues reported here. The paper also explores potential solutions to such dilemmas, especially in centres without FACT-JACIE accreditation.
Conclusion/perspective
The risk of transplant coordinators’ pressuring potential donors to donate against their will is highly deserving of consideration because it is as dangerous as having the same physician treat patients and assess donors. Societal norms and pressures should be considered, particularly within Saudi Arabian culture, as they may lead to donations made without free and full consent. Health care providers may lose their ethical orientation in this context, especially in unaccredited hospitals or understaffed units. Creating a healthy donor programme is the key to safe practices that preserve donors’ rights, reduce pressure on primary teams and ensure application of international JACIE standards.

How Do Prescribing Clinicians Obtain Consent to Initiate Gender-Affirming Hormones?

How Do Prescribing Clinicians Obtain Consent to Initiate Gender-Affirming Hormones?
Gaines Blasdel, Avery Everhart, Colt St. Amand, Monica Gaddis, Frances Grimstad
Transgender Health, 21 June 2022
Abstract
Purpose
Multiple consent models exist for initiating gender-affirming hormone therapy (GAHT). Our study aim was to examine the variety of approaches utilized by clinicians.
Methods
Online and in-person recruitment of clinicians involved in gender-affirming care was undertaken from June 2019 through March 2020. Participants completed an online survey.
Results
Of the 175 respondents, 148 prescribed GAHT. Sixty-one (41.2%) prescribed to adults only, 11 (7.4%) to minors only, and 76 (51.4%) prescribed to adults and minors. Of those who prescribed to adults, more than half (n=74, 54.4%) utilized a written consent model, one-fourth only verbal consent (n=33, 24.3%), and one-fifth required an additional mental health assessment (MHA) (n=29, 21.3%). Of those prescribing to minors, most required either written consent (n=39, 44.8%) or an additional MHA (n=35, 40.2%). Only 11 (12.6%) utilized only verbal consent for minors. Rationales provided for requiring an additional MHA in adults included protection from litigation, lack of competence in assessing psychosocial readiness for GAHT, and believing that this is the best way to ensure the patient has processed the information. Practicing in multidisciplinary clinics was associated with not requiring an MHA for adult GAHT.
Conclusion
Clinicians across fields are utilizing different models to provide the same treatment, with varying rationales for the same model. As a result, patients receive nonstandard access to care despite similar clinical presentations. Our study highlights an important area for further improvement in GAHT care.

Informed consent prior to nursing care: Nurses’ use of information

Informed consent prior to nursing care: Nurses’ use of information
Research Article
Helen Aveyard, Abimola Kolawole, Pratima Gurung, Emma Cridland, Olga Kozlowska
Nursing Ethics, 20 June 2022
Abstract
Background
Informed consent prior to nursing care procedures is an established principle which acknowledges the right of the patient to authorise what is done to him or her; consent prior to nursing care should not be assumed. Nursing care procedures have the potential to be unwanted by the patient and hence require an appropriate form of authorisation that takes into consideration the relationship between the nurse and patient and the ongoing nature of care delivery.
Research question
How do nurses obtain consent from patients prior to nursing care?
Design
Critical incident technique and the collection of critical happenings.
Participants
17 participants who were all qualified nurses took part in in-depth interviews
Ethical considerations
Ethical approval was obtained from the university ethics committee.
Findings
Information giving is a key component prior to nursing care procedures. Nurses provide information to patients as a routine aspect of care delivery, and do so even when the patient is unable to communicate themselves. Whilst some participants described how information giving might be rushed or overlooked at times, it is clearly an established part of nursing care and is provided to ensure the patient knows what to expect when care is delivered. What is less clear is the extent to which information is given in order to seek the consent – rather than merely inform the patient – about nursing care.
Conclusion
Implied consent is often an appropriate way in which consent is obtained prior to nursing care procedures. It takes into account the ongoing care provision and the relationship that exists between the nurse and patient. However implied consent should not be assumed. Nurses need to ensure that information is given not only to inform the patient about a procedure but to enable the patient to give his or her consent and to find an alternative way forward if the patient withholds their consent.

Nocebo effects on informed consent within medical and psychological settings: A scoping review

Nocebo effects on informed consent within medical and psychological settings: A scoping review
Research Article
Nadine S. J. Stirling, Victoria M. E. Bridgland, Melanie K. T. Takarangi
Ethics & Behavior, 8 June 2022
Abstract
Warning research participants and patients about potential risks associated with participation/treatment is a fundamental part of consent. However, such risk warnings might cause negative expectations and subsequent nocebo effects (i.e., negative expectations cause negative outcomes) in participants. Because no existing review documents how past research has quantitatively examined nocebo effects – and negative expectations – arising from consent risk warnings, we conducted a pre-registered scoping review (N = 9). We identified several methodological issues across these studies, which in addition to mixed findings, limit conclusions about whether risk warnings cause nocebo effects.