Getting the Gist Across Is Enough for Informed Consent for Acute Stroke Thrombolytics
Comments and Opinions
Skolarus LE, O’Brien A, Meurer WJ , Zikmund Fisher BJ
Stroke, 14 May 2019
Acute stroke thrombolytics greatly reduce poststroke disability, both in clinical trails and in clinical practice. Too few patients, however, take advantage of these life-improving and cost-saving treatments. In fact, in the United States, up to 7.5% of tPA (tissue-type plasminogen activoator) eligible patients refuse this time limites stroke treatment , and even among stroke patients who receive tPA, up to 20% experience delayed treatment due to patient and family consent…

Assessing adequacy of informed consent for elective surgery by student‐administered interview
Original Article
Clement L. K. Chia, Kai Siang Chan, Marcus J. M. Ng, Anil D. Rao, Reyaz Singaporewalla
ANZ Journal of Surgery, 14 May 2019
Abstract
Background
Studies show that patients often sign consent documents without fully comprehending the risks, benefits and potential complications. There is currently no Asian study performed analysing adequacy of informed consent. This study aims to assess adequacy of informed consent by evaluating patient understanding and retention of key information and complications pertaining to surgery via medical student‐administered interview.
Methods
A prospective study was performed on 48 patients undergoing groin hernia surgery, laparoscopic cholecystectomy and total thyroidectomy from 2017 to 2018 in a teaching hospital. Standardized assessment forms including major common complications and key details of the surgery were prepared. Structured one‐to‐one interviews between students and patients were performed and recorded on the morning of surgery.
Results
Although 93.8% of the patients claimed to have understood the information regarding their surgery, only 19.4%, 44.4% and 62.5% of the patients could actually recall the serious complications of groin hernia surgery, laparoscopic cholecystectomy and thyroidectomy, respectively. Elderly patients (>65 years) had poorer understanding of surgical procedure compared to the young (80% versus 100%, respectively, P = 0.008) with 26.7% of elderly patients claiming that they did not understand the indication for surgery. High satisfaction rates with this preoperative interview were reported by both patients and students (95.8% and 97.9%, respectively). Time interval from informed consent to surgery did not make any difference.
Conclusion
Understanding of information and key complications was generally low, especially in the elderly population. The structured preoperative interview achieved the dual goal of reinforcing patient gaps in knowledge and improving student communication skills.

Assessment of Use, Specificity, and Readability of Written Clinical Informed Consent Forms for Patients With Cancer Undergoing Radiotherapy
Original Investigation
Subha Perni, Michael K. Rooney, David P. Horowitz, Daniel W. Golden, Anne R. McCall, Andrew J. Einstein,  Reshma Jagsi
JAMA Oncology, 2 May 2019
Abstract
Importance  
Appropriate informed consent processes are crucial to preservation of patient autonomy and shared decision making. Although half of patients with cancer receive radiotherapy, it is unknown whether current consent practices are comprehensible for patients.
Objective  
To characterize use, specificity, and readability of clinical informed consent forms for radiotherapy, hypothesizing that forms would be higher than the recommended sixth- to eighth-grade readability level.
Design, Setting, and Participants
This nationwide cross-sectional survey study and readability analysis was conducted from 2016 to 2018 and included 89 academic radiation oncology departments that were part of the 2016 Electronic Residency Application Service. Department leaders (clinical directors, chairs, and personal contacts of study authors) at academic radiation oncology departments were contacted via email.
Main Outcomes and Measures  
Readability levels were measured by 7 validated readability indices, including the Ford, Caylor, Sticht (FORCAST) index for nonnarrative texts. Difficult words were identified using The Living Word Vocabulary, which describes the readability grade levels of 40 000 common words.
Results  
Of 89 departments, 67 (75%) responded to questions and 57 (64%) provided 113 forms for analysis. Departments providing forms did not differ substantially from others in terms of region, residency size, research output, rural vs urban location, or public vs private institution status. All departments obtained patient written informed consent before radiotherapy; 38 (57%) used body site–specific forms. Using the most conservative (low-score) estimate, mean form readability ranged from grade level 10.6 to 14.2. By 7 distinct indices, only 9 (8%) of 113 forms met the recommended eighth-grade readability level, and 4 (4%) forms met a sixth-grade level. Not a single form met either recommendation based on the FORCAST index. Forms used an average of 7.2 difficult words. Body site–specific forms had considerably better readability than general consent forms.
Conclusions and Relevance  
This nationwide study of informed consent practices for cancer treatment with radiotherapy demonstrates that while all US academic radiotherapy departments use written consent forms, it is rare for templates to meet the recommended readability levels for patient materials. These data suggest the need for reevaluation and modification of the approach to radiotherapy consent, ideally with guidance and templates designed by national professional organizations.

What is in a Name? Parent, Professional and Policy-Maker Conceptions of Consent-Related Language in the Context of Newborn Screening 
Stuart G Nicholls, Holly Etchegary, Laure Tessier, Charlene Simmonds, Beth K Potter,Jamie C Brehaut, Daryl Pullman, Robin Z Hayeems, Sari Zelenietz, Monica Lamoureux, Jennifer Milburn, Lesley Turner, Pranesh Chakraborty, Brenda J Wilson
Public Health Ethics, 4 May 2019
Abstract
Newborn bloodspot screening programs are some of the longest running population screening programs internationally. Debate continues regarding the need for parents to give consent to having their child screened. Little attention has been paid to how meanings of consent-related terminology vary among stakeholders and the implications of this for practice. We undertook semi-structured interviews with parents (n = 32), healthcare professionals (n = 19) and policy decision makers (n = 17) in two Canadian provinces. Conceptions of consent-related terms revolved around seven factors within two broad domains, decision-making and information attainment. Decision-making comprised: parent decision authority; voluntariness; parent engagement with decision-making; and the process of enacting choice. Information ascertainment comprised: professional responsibilities (including disclosure of information and time to review); parent responsibilities; and the need for discussion and understanding prior to a decision. Our findings indicate that consent-related terms are variously understood, with substantive implications for practice. We suggest that consent procedures should be explained descriptively, regardless of approach, so there are clear indications of what is expected of parents and healthcare professionals. Support systems are required both to meet the educational needs of parents and families and to support healthcare professionals in delivering information in a manner in keeping with parent needs.

The quality of informed consent obtained for orthopedic surgeries-elective versus trauma: A prospective interview-based study
Shemesh S, Sidon E, Heller S, Cohen N, Kosashvili Y, Dovrat R, Velkes S, Burg A
Journal of Orthopaedic Surgery (Hong Kong), 1 May 2019; 27(2)
Abstract
Background
Orthopedic surgeons routinely obtain informed consent prior to surgery. Legally adequate informed consent necessitates a thorough discussion of treatment options and risks and proper documentation. However, the quality of informed consent in orthopedic trauma patients is an under-researched area.
Purpose
To assess the quality of the informed consent process in trauma compared with elective orthopedic patients and to assess patients’ emotional state at the time of signing consent form.
Methods
Sixty-two consecutive patients undergoing either elective total joint arthroplasty ( N = 32) or orthopedic trauma surgery ( N = 30) were included. The data were collected through personal interviews using a proposed informed consent score. The interviews were held after obtaining the informed consent and before the index procedure. Patients were asked to describe their diagnosis, the surgical procedure, its’ benefits, and risks as well as alternative treatments.
Results
Mean age differed significantly between elective and trauma group patients (66.1 vs. 51.6, respectively, p < 0.01), while gender and education level were comparable ( p = 0.075, p = 0.55, respectively). The quality of consent was significantly better for patients with post-high-school education compared to elementary education level (consent score: 16.9 ± 4.1 vs. 12.2 ± 5.5, p = 0.021). Patients in the elective group showed an overall higher quality of consent, as reflected by a mean score of 17.03 ± 4.2 versus a mean score of only 13.73 ± 4.7 in the trauma group ( p = 0.005, 95% CI: 1.02-5.57). Specifically, trauma patients demonstrated a lower comprehension of the diagnosis, the benefits of surgical treatment, the possible complications, and the expected postoperative course.
Conclusion
Patients undergoing trauma surgery are significantly more likely to have an inadequate understanding of the proposed treatment. These findings raise questions concerning the validity of consent from trauma patients.

Partnering with Patients and Families during Childbirth: Confirming Knowledge for Informed Consent
Simpson, Kathleen Rice
The American Journal of Maternal/Child Nursing, May/June 2019; 44(3) pp 180
Abstract
There are many opportunities during hospitalization for childbirth to offer information to the woman and her family about various options and choices for clinical care and treatment. Women should be provided information at their appropriate literacy level and language to make decisions about their care in partnership with the health care team. While events of labor and births may seem routine to clinicians, they are usually not for patients. Therefore, shared decision-making approaches and patient consent are essential throughout the childbirth hospitalization.

Informed Consents or Consent of Information? Assessing Quality of Informed Consents for Scheduled Cesarean Section [9I]
Janelle Jackman, Carolina Martinez, Erroll Byer, Kimen Balhotra
Obstetrics & Gynecology, May 2019; 133 pp 97S–98S
Abstract
Introduction
Informed consents of patients undergoing procedures are important not only for ethical and legal reasons but also for the quality of care. Patients’ understanding allows for better cooperation, improves results and satisfaction and also helps prevent errors. Providers must ensure that the patient understands the nature of their condition, the risks and benefits of the procedure, the alternatives and agrees voluntarily. Although consents are a well-established practice, it often fails to meet its purpose. Providers must realize that signing a consent form is not equivalent to receiving informed consent.
Methods
A cross sectional survey of patients admitted for scheduled cesarean section. The anonymous questionnaires were administered within 30 minutes to 48 hours of having the consent explained. The questions focused on patient’s recall of information about the explanation of the procedure, risks and alternatives, preferences about the decision process and overall satisfaction with the manner in which the consent was obtained.
Results
Only 9% of the patients didn’t receive explanations about risks but 42% didn’t have discussions of alternative options. Most patients (70%) weren’t asked to repeat the explanation. Expectations about decision varied, with 65% favoring shared decision and nearly 26% preferring autonomous decision. Satisfaction was rated as good or very good by 94% of patients.
Conclusion
In conclusion, most patients do not remember receiving explanations about alternatives for procedures nor are they asked to repeat explanations. We recommend that the quality of consents be regularly assessed, to ensure informed consent is being obtained.