Do hospital consent forms for cardiology procedures meet health literacy standards? Evaluation of understandability and readability
Ruwani Peiris, Samuel Cornell, Kim Greaves, Carissa Bonner
Patient Education and Counseling, 14 September 2021
Consent forms that are difficult to understand may jeopardize informed consent. The aim of this study was to determine whether consent documents for cardiology-related procedures could be easily read and understood by patients with low health literacy.
All 37 cardiology-related consent forms with patient information material were retrieved from a publicly available suite of documents from one state in Australia. Two raters independently assessed documents and resolved discrepancies through discussion. Understandability was assessed using the Patient Education Materials Assessment Tool for Printed materials (PEMAT-P). Readability was assessed using the Gunning Fog Index, SMOG and Flesch Reading Ease formulas. Images were assessed using the 5C Image checklist. Results were analyzed descriptively.
Only 1 of 37 forms met the general PEMAT-P threshold (70%) for being ‘understandable’. The average readability score was high, requiring a grade 10–12 level of education to understand. Most images lacked useful captions, had low visual clarity, and were not purpose-designed for the material.
The current format for cardiology consent forms does not meet recommended standards for understandability and readability.
Development of consent forms would benefit from taking health literacy principles into account with patient input, and purpose-designed images should be included in all forms to reinforce text.
The ethics of informed consent and shared decision-making in pediatric surgery
Deborah S. Loeff, Baddr A. Shakhsheer
Seminars in Pediatric Surgery, 5 September 2021
Informed consent is a required feature in the practice of pediatric surgery. Surgeons cannot practice the trade without it and most of us learned to do it as part of our “apprenticeship” in surgical training. We were bystanders when the senior resident or attending spoke to the patient and family and we were silent witnesses to the signing of the document called a “consent.” Intentional instruction about informed consent is rudimentary in most residencies. By the time we become surgical fellows, it is assumed that we have the requisite skill set to perform this “task” so we can get on with what we like to do best; operating. For many, it is viewed as a perfunctory step which, if done properly, will comply with hospital policies, might someday be exhibited during medical litigation, and ultimately it will occupy a tiny bit of memory in the hospital EMR system. However, this “thing” called the informed consent is much more than an item on a pre-op check list. The re-branding of the term “informed consent” into “shared decision-making” underscores the “re-evolution” that has occurred in thought and practice from the act of obtaining an individual’s permission for treatment toward the process leading up to that act.1 It reflects some of our most important ethical values in healthcare and is still the source of scholarly inquiry and controversy. In this paper, the terms “informed consent” and “shared decision-making” will be used interchangeably but the intention is focused on the process of how physicians and their patients make choices together. If you have not thought about this topic recently, I encourage you to take a moment and explore some of the interesting and challenging questions which are still unanswered. Although the ethical principles underlying informed consent are shared by adult and pediatric medicine, there are many aspects which are unique to the medical care of children. This article highlights some of those challenges and controversies illustrated by two case studies and viewed through the lens of bioethics.
A Survey to Assess the Informed Consent Practices of Physicians Caring for oocyte Donors
Christina Shields, Winifred Mak
Fertility and Sterility, 1 September 2021; 116(3)
With increasing demand for donor oocytes, appropriate informed consent of oocyte donors (OD) is a priority as these women assume risk for a procedure that does not directly benefit them. Our study sought to investigate how physicians counsel on risks as part of informed consent of OD.
Materials and Methods
Physicians involved in the care of OD were invited to complete an anonymous 17-question online survey which included demographic variables and assessment of counseling practices such as whether short- and long-term complications are discussed with OD. The University of Texas Institutional Review Board approved the study.
96 physicians responded (estimated response rate 17%). Respondents work in academic institutions (48%), private fertility clinics (46%), practices affiliated with commercial egg banks (6%), practices affiliated with academic institutions (11%), and are located across the Northeast (30%), Southeast (23%), Midwest (27%), Southwest (8%), and West (12%). Respondents in our study most often obtain consent either in person only or in person with other educational material. 98% responded that they always counsel on short-term potential side effects, versus 70% who always counsel on long-term potential side effects. A majority reported counseling on the incidence of ovarian hyperstimulation syndrome (OHSS) as 1-5% and acute serious complication (ASC) as <0.5% in accordance with the American Society for Reproductive Medicine (ASRM) bulletin on oocyte donation. The most discussed side effects are moderate pain / discomfort (100%), OHSS (96%), bloating (93%), intraperitoneal bleeding (79%), infection (78%), and ovarian torsion (78%). Interestingly, 21% also discussed general risk of cancer and 26% discussed risk of ovarian cancer. Regarding the maximum number of oocyte donation cycles, 65% of physicians recommend no more than 6 cycles and 32% recommend 3-5 cycles. Only 56% of respondents are aware of literature investigating long-term health outcomes of OD. Finally, 78% agree or strongly agree there should be a modality to track long-term health outcomes of OD.
Reassuringly, the majority of the physicians in our study counsel OD appropriately according to the ASRM guidelines and therefore from a physician’s perspective, appropriate informed consent is being obtained. There is a knowledge gap on long-term health outcomes of OD, likely due to lack of research in this area. Most physicians caring for OD agree that long-term health outcomes should be tracked.
Are Patients Willing to Be Informed on the Risks and Complications Associated with the Proposed Therapy? A Survey on Informed Consent
Aigli Dafni, Panagoula Oikonomou, Konstantinos Anagnostopoulos, Christos Tsalikidis, Nigyar Dzhafer, Alexandra K. Tsaroucha, Mickael S. Pitiakoudis
Folia Medica, 31 August 2021; 63(4) pp 569-575
Informed consent is essential to the patient-physician relationship. The paternalistic old-time approach used by physicians to achieve the optimal management is changing today; detailed medical information must be disclosed to the patients regarding their health problem.
The aim of this study was to highlight the value of informed consent in the context of medical practice as well as to emphasize its importance through the prism of human rights.
Materials and methods
A patient survey was conducted in two public and one private hospitals in Greece. Eighty-three inpatients from the Surgical Departments of Democritus University Hospital of Alexandroupolis (DUHA), Laikon University Hospital of Athens (LUHA) and a private hospital were included in the study. A questionnaire regarding patients’ attitude towards informed consent was distributed to patients prior to surgery.
The majority of the patients (63.86% in DUHA, 59.38% in LUHA, and 78.95% in the private hospital) opted for full disclosure regarding the course and development of their condition.
Patients want to be informed about their treatment options and possible complications so that they can make decisions about their treatment after a comprehensive and understandable discussion.
Informed consent and birth preparedness/complication readiness: A qualitative study at two tertiary maternity units
Sally Ely, Susanne Langer, Hans Peter Dietz
The Australian and New Zealand Journal of Obstetrics and Gynaecology, 29 August 2021
Informed consent in obstetrics should involve full disclosure of risks, benefits and alternative interventions. However, we have found no evidence of a formal informed consent process before an attempt at vaginal delivery in published policy or practice. The idea of informed consent in vaginal birth has attracted controversy and has been the subject of some debate.
To explore the perspectives and experiences of informed consent and birth preparedness/complication readiness for birthing women in a high resource setting.
Materials and methods
Qualitative study using semi-structured interviews to examine experiences and perspectives of women following birth.
Forty telephone interviews were concluded. Eight statement categories were identified: (i) no issues of consent, (ii) absent/inadequate informed consent, (iii) adequate birth preparedness/complication readiness, (iv) inadequate birth preparedness/complication readiness, (v) desire to forfeit decision making to a trusted and accountable health professional, (vi) belief that informed consent is not realistic in birth under some circumstances, (vii) negative feelings related to birth and (viii) poor postnatal follow-up.
When complications arose during birth, 20% of participants felt that informed consent was absent/inadequate, 25% of participants suggested policy change in favour of a formal informed consent process and 55% of participants suggested policy change in favour of increased birth preparedness/complication readiness. Our study suggests that informed consent for vaginal birth and formal birth preparedness/complication readiness should form part of routine antenatal care. Women’s preferences for decision-making and informed consent should be established before birth.
Ethical evaluation of informed consent forms used in cardiology clinics and the importance of institutional standardized approach
Aksüyek Savaş Çelebi, Perihan Elif Ekmekçi, Müberra Devrim Güner
Turkish Society of Cardiology, 9 February 2021; 49(6) pp 477-487
This study aimed to evaluate the content of informed consent forms (ICFs) used during cardiology interventions by the university, research and training (R&T), and private hospitals with regard to ethical standards and compare them with the Turkish Society of Cardiology (TSC) templates and among various institutions.
A total of 185 forms from the university, R&T, and private hospitals and 19 TSC templates were selected and analyzed for 26 criteria. Compliance with TSC templates was also evaluated. Data were presented as the percentage of ICFs satisfying the criteria and compared using the Fisher exact test, and 95% confidence intervals were calculated.
TSC templates were more compatible and included more information to comply with ethical standards than ICFs of all 3 types of healthcare institutions. The areas of improvement for these templates were prospects of treatment and alternative treatments, quality of life, explanation for third-party consent, duration of hospitalization, and time to return to normal life. Among the 3 types of hospitals, R&T-ICFs were more compatible with templates. Private hospital ICFs had the poorest compliance with TSC templates. Separate anesthesia ICFs and detailed information about exposure to radioactivity were lacking.
The current ICFs for cardiology interventions have major ethical deficiencies and need urgent improvement. Professional societies such as TSC are essential institutions to develop and provide guidance and templates for ICFs to meet the ethical standards during the informed consent process and standardization of the process among various institutions.
Informed Consent in Dentistry – When, Why and How
Studia Universitatis Babes-Bolyai Bioethica, 2021; 65 pp 147
For dentists, as well as for other health care practitioners, it is mandatory to obtain informed consent from their patients, implying that a dialog has taken place and that patients understand the risks, benefits and alternatives to rendered treatments. Having in mind that majority of dental procedures are surgical in nature, leading to irreversible change to orofacial tissues and with the risk of unwanted side effects, well-documented informed consent process needs to be a basic norm in the dental practice. Clinical experience suggests that verbal discussion along with providing informed consent forms may not be enough and that patients response and understanding may improve by adding adjunctive materials like brochures or videos related to planned procedures. Many companies for implants and dental materials supply dental offices with the brochures and pamphlets, mostly for marketing purposes. Therefore, the use of these materials must be used with caution while objectively discussing other reasonable options. With the increasingly growing phenomenon of dental tourism, an important dentist-patient relationship ethical issues arise. Namely, issues regarding patient autonomy over practitioner choice, patient safety, and optimal care are under constant reconsideration while informed consent has to specify circumstances underlying treatment plan and posttreatment care. Currently, there is a paucity of information regarding informed consent in dentistry, and vital ethical issues associated with recent developments in dental practice need to be addressed in the near future.
Practice variation in the informed consent procedure for thrombolysis in acute ischemic stroke: a survey among neurologists and neurology residents
Valentijn J. Zonjee, Jos P. L. Slenders, Frank de Beer, Marieke C. Visser, Bastiaan C. ter Meulen, Renske M. Van den Berg-Vos, Sander M. van Schaik
BMC Medical Ethics, 25 August 2021; 22(114)
Obtaining informed consent for intravenous thrombolysis in acute ischemic stroke can be challenging, and little is known about if and how the informed consent procedure is performed by neurologists in clinical practice. This study examines the procedure of informed consent for intravenous thrombolysis in acute ischemic stroke in high-volume stroke centers in the Netherlands.
In four high volume stroke centers, neurology residents and attending neurologists received an online questionnaire concerning informed consent for thrombolysis with tissue-type plasminogen activator (tPA). The respondents were asked to report their usual informed consent practice for tPA treatment and their considerations on whether informed consent should be obtained.
From the 203 invited clinicians, 50% (n = 101) completed the questionnaire. One-third of the neurology residents (n = 21) and 21% of the neurologists (n = 8) reported that they always obtain informed consent for tPA treatment. If a patient is not capable of providing informed consent, 30% of the residents (n = 19) reported that they start tPA treatment without informed consent. In these circumstances, 53% of the neurologists (n = 20) reported that the resident under their supervision would start tPA treatment without informed consent. Most neurologists (n = 21; 55%) and neurology residents (n = 45; 72%) obtained informed consent within one minute. None of the respondents used more than five minutes for informed consent. Important themes regarding obtaining informed consent for treatment were patients’ capacity, and medical, ethical and legal considerations.
The current practice of informed consent for thrombolysis in acute ischemic stroke varies among neurologists and neurology residents. If informed consent is obtained, most clinicians stated to obtain informed consent within one minute. In the future, a shortened information provision process may be applied, making a shift from informed consent to informed refusal, while still considering the patient’s capacity, stroke severity, and possible treatment delays.
A Critical Appraisal of Variability in Informed Consent for Vascular Access Procedures
Blake Hotchkiss, Judy Thompson
Journal of the Association for Vascular Access, 18 August 2021
Vascular access device insertion is one of the most performed procedures in healthcare today. With different device types available to provide infusion therapy, there are many different variables to consider, including the process of obtaining informed consent from patients. This literature review aims to discuss common themes present in current evidence-based practice and point out critical areas of variability that exist.
A literature review was conducted searching Cochrane Library, Joanna Briggs Institute for Evidence-Based Practice, Cumulative Index to Nursing and Allied Health Literature, PubMed, and Google Scholar databases for recently published articles in the English language and those written in English. Articles were screened to include those that describe informed consent within the context of vascular access or other invasive procedures. There were 35 articles and 5 systematic reviews identified that met criteria for inclusion in this literature review.
The topics of ethics, legal responsibility, who provided consent, and how education about procedures was performed demonstrated clear insight into how to improve the consent process. Some areas in current evidence lack clear direction and create variability in the informed consent procedure. These included who should obtain consent from the patient and which vascular access devices required a written consent. Who obtains consent was found to be more related to current legal precedence and not the clinician inserting the device like that found when a nonphysician clinician performed the procedure. Vascular access device related variability in requiring written versus verbal consent was found to be rooted in the degree of complexity of the procedure, need for specialized training, and the inherent risk to the patient.
These two areas of variability described in current clinical practice require more research and consensus agreement to standardize the practice of obtaining informed consent in vascular access device insertion.
Does radiology require informed consent for radiation risk?
Elizabeth M Davies, Andrew J Bridges, Emma ML Chung
The British Institute of Radiology, 6 August 2021
Recent trends in medical decision-making have moved from paternalistic doctor-patient relations to shared decision-making. Informed consent is fundamental to this process and to ensuring patients’ ongoing trust in the health-care profession. It cannot be assumed that patients consent to the risk associated with medical exposures, unless they have been provided with the information to make that decision. This position is supported by both the legal and ethical framework around Radiation Protection detailed in this commentary.