Balancing values and obligations when obtaining informed consent: healthcare professionals’ experiences in Swedish paediatric oncology
Regular Article
Anna Schröder Håkansson, Pernilla Pergert, Jonas Abrahamsson, Margaretha Stenmarker
Acta Paediatrica Nurturing the Child, 13 September 2019
Abstract
Aim
To explore Swedish healthcare professionals’ (HCPs) clinical experiences of the informed consent process (ICP) and to compare experiences between the professions.
Methods
In this nationwide study six paediatric oncologists (POs) and eight research nurses (ReNs) from all Swedish paediatric oncology centres were interviewed. The material was analysed using Grounded theory, a qualitative constant comparative method.
Results
The participants’ main concern was how to fulfil research obligations without putting too much strain on a family in acute crisis, which led to the core category of balancing values and obligations of both healthcare and research. To handle the challenges the participants’ struggled to safeguard the families from psychological harm, tried to adjust to the families, and gradually introduced research while building trust. The conceptual model developed in the study highlights potential consequences of this balancing act with a risk of diminishing the family’s autonomy through HCPs acting authoritatively (in particular POs) or with overprotection (in particular ReNs).
Conclusion
Paediatric oncology is a research integrated healthcare environment. The HCPs need personal, professional and institutional support regarding ICP‐related ethical issues, decisions and implications in this intertwined context. Furthermore, HCPs need to be aware of the potential long‐term risk of developing professional moral distress.

“Uninformed” Consent: Patient Recollection From Surgical Consent in Hand Surgery—A Quality Improvement Initiative
Research Article
Monica Yu, Herbert P. von Schroeder
HAND, 5 September 2019 
Abstract
Background
Informed surgical consent is necessary and routine; however, it can have significant inadequacies. Our purpose was to investigate patient recollection of the surgical consent process and evaluate adequacy from the patient’s perspective.
Methods
A quality improvement framework was used. Two patient surveys capturing information recall and satisfaction of the consent process were administered in 5 consecutive hand clinics. All patients who previously underwent elective hand surgery were included.
Results
There was exceptionally low recall of the risks and benefits of surgery in 103 consecutive patients who underwent hand surgery. Patients under age 35 had slightly better recall of surgical risks. Unexpected postoperative events affected patient perceptions of the consent process.
Conclusions
Patients who have undergone elective hand surgery have poor recollection of the information discussed during the surgical consent process, and therefore the process is lacking. Surgeons may falsely assume that the consent process is sound because it is erroneously perceived as being sufficient by most patients.

Is There a Difference Between the Readabilities of Informed Consent Forms Used for Elective and Emergency Procedures in Turkey?
Research Article
Mehmet Giray Sönmez, Leyla Öztürk Sönmez, Betül Kozanhan, Zerrin Defne Dündar
Therapeutic Innovation & Regulatory Science; 5 September 2019 
Abstract
Background
Informed consent is an important aspect of ethical medical practice. In legal terms, making an intervention without informed consent may mean negligence or malpractice and may lead to legal action, maltreatment, and even attack against the doctor. This study aims to evaluate the readability of informed consent forms (ICFs) used for elective (urology and general surgery) and emergency procedures (emergency medicine and intensive care) by comparing through readability formulas.
Methods
Elective and emergency ICFs were accessed through the web sites of national health care associations. A total of 387 consent forms were evaluated and the same forms were included only once. A total of 35 consent forms were evaluated for emergency procedures, while a total of 55 consent forms were evaluated for elective procedures. Ateşman and Bezirci-Yılmaz formulas defined for determining the readability level of Turkish texts and Gunning fog and Flesch Kincaid formulas measuring the general readability level were used for calculating the readability level of consent forms.
Results
Even though elective ICFs are more readable compared to those of emergency procedures according to Bezirci-Yılmaz formulas, this was statistically insignificant (P = .54). The readability of elective consent forms was found to be at a significantly more difficult level to read compared to Ateşman, Gunning fog, and Flesch Kincaid formulas (P = .002, P < .001, P < .001, respectively).
Conclusion
Even though the procedure is emergency or elective, a difficult readability level may cause problems for the doctor in legal phases. Readable and understandable consent forms should be available to be able to explain morbidity and mortality and improve prognosis. Education level of our country should also be considered while preparing these consent forms.

Utilization of a Parental Approach to Informed Consent in Intravenous Tissue Plasminogen Activator Administration Decision-Making: Patient Preference and Ethical Considerations
Research Article
Ann M. Murray, Ashley B. Petrone, Amelia K. Adcock
Neurology Research International, 5 September 2019
Abstract
Objective
While administration of intravenous tissue plasminogen activator (IV-tPA) is the standard of care in acute ischemic stroke and has been shown to have statistically significant benefit, there can also be potentially life-threatening complications; however, there is no standard informed consent approach. (e purpose of this study was to present a parental, technical, and general model of informed consent for IV-TPA and to determine which approach was preferred.
Methods
Survey respondents were asked to hypothetically decide whether or not to provide consent for their family member to receive IV-tPA. Respondents were presented with 3 informed consent models: one emphasizing parental qualities, one emphasizing statistical data, and one representing a general consent statement. After being presented each model, the respondents had to select their preferred consent model, as well as rate their level of agreeability toward their family member receiving the medication following each approach.
Results
(e results of 184 surveys showed respondents were equally as likely to give consent for their family member to receive IVTPA following all three approaches; however, respondents were significantly more likely to prefer the parental approach compared to a technical or general approach.
Conclusion
Our results indicate that while paternalism is generally discouraged in the medical community, some degree of parental language may be preferred by patients in tough decision-making situations toward consent to receive medical interventions.

Signature Informed Consent for Long-Term Opioid Therapy in Patients with Cancer: Perspectives of Patients and Providers
Original Article
Karleen Giannitrapani, Soraya Fereydooni, Azin Azarfar, Maria J. Silveira, Peter A. Glassman, Amanda Midboe, Amy Bohnert, Maria Zenoni, Robert D. Kerns, Robert A. Pearlman, Steven M. Asch, William Becker, Karl A. Lorenz
Journal of Pain and Symptom Management, 30 August 2019
Abstract
Context
Signature informed consent (SIC) is a part of a Veterans Health Administration (VHA) ethics initiative for patient education and shared decision-making with long-term opioid therapy (LTOT). Historically, patients with cancer-related pain receiving LTOT are exempt from this process.
Objectives
Our objective is to understand patients’ and providers’ perspectives on using signature informed consent for LTOT in patients with cancer-related pain.
Methods
Semi-structured interviews with 20 opioid prescribers and 20 patients who were prescribed opioids at two large academically-affiliated VHA Medical Centers. We employed a combination of deductive and inductive approaches in content analysis to produce emergent themes.
Results
Potential advantages of SIC are that it can clarify and help patients comprehend LTOT risks and benefits, provide clear upfront boundaries and expectations, and involve the patient in shared decision-making. Potential disadvantages of SIC include time delay to treatment, discouragement from recommended opioid use, and impaired trust in the patient-provider relationship. Providers and patients have misconceptions about the definition of SIC. Providers and patients question if SIC for LTOT is really informed consent. Providers and patients advocate for strategies to improve comprehension of SIC content. Providers had divergent perspectives on exemptions from SIC. Oncologists want SIC for LTOT to be tailored for patients with cancer.
Conclusion
Provider and patient interviews highlight various aspects about the advantages and disadvantages of requiring SIC for LTOT in cancer-related pain. Tailoring SIC for LTOT to be specific to cancer related concerns and to have an appropriate literacy level are important considerations.