Valid consent and orthodontic treatment
Maurice J Meade, Annalene Weston, Craig W Dreyer
Australasian Orthodontic Journal, May 2019; 35(1) 
Abstract
Valid patient consent is a legal and ethical principle that is fundamental to healthcare provision. Oral health practitioners (OHPs) must understand the principles that need to be addressed to ensure that the consent given by a patient is valid. Failure to obtain consent may result in a negligence claim or a complaint of professional misconduct against the OHP. Orthodontic treatment is mostly elective but is not without risk to the patient. Obtaining and maintaining valid consent for orthodontic treatment presents additional challenges in comparison with other dental procedures as the treatment lasts over a longer time and is most commonly performed in adolescents. In addition, prospective patients need to be informed regarding ‘lifelong’ management in the retention phase to minimise the risk of relapse. The present paper outlines the principles of valid consent with particular regard to orthodontic treatment in the adolescent patient. OHPs must ensure that they are satisfied that the competent patient has the capacity to voluntarily consent. Clinicians must also recognise that valid consent is not a one-off ‘tick the box’ procedural exercise but an ongoing process of effective information sharing in light of changing laws and an ever-changing scientific evidence base within a patient-centred model of healthcare.

Perceptions and Perspectives of Patients regarding process of informed consent in a tertiary care hospital
Original Article
Shanaz Kouser, Tahira Fatima, Zunaira Tabassum, Khushbakht Anwar
Pakistan Journal of Medical and Health Sciences, January – March 2019
Open Access
Abstract
Aim
To analyze the patient’s perceptions and perceptive about different components and procedure of taking informed consent in a tertiary care hospital
Methods
This was a cross sectional study conducted with a predesigned interview based questionnaire form. 150 patients who underwent cesarean section, were randomly selected for study at Jinnah Hospital, Lahore, which is a tertiary care multidisciplinary hospital. Patients who had some emergency surgical procedures, patients who belonged to a medical profession and the patients who refused to be interviewed were excluded from the study. Data was analyzed in SPSS Ver:17.0. Frequencies and percentages were calculated for demographic and perception process regarding informed consent.
Results
A total of 150 patients were included in the study. Age range of the patients, who were interviewed was 18-44 years. Majority of the patients were primipara 89(59.3%).Out of all cases, 64(42.7%) of patients were from rural areas and 88 patients (58.7%) belonged to poor socioeconomic class. Almost half of the patients 77(57.3%) were uneducated. It was observed that husbands, parents in law and patient’s own parents were somehow or other were involved in the decision making process. In 107 cases (71.3%), the consent form was signed by the husband. The other forms were signed by mother in law 12( 8%) and by patient’s own parents 31(20.7%), surprisingly none of the patients signed her own consent form as primary consenting person though they were told about the reasons for cesarean section (n=134, 89.3%) by the signatory.
Conclusion
Majority of the patients in our set-up were satisfied with the process of informed consent, though at times, some of them were not fully aware about indications, risks and benefits of the surgery.

Consent in gastrointestinal endoscopy: valid, informed and nurse-led
Christine Metcalf
Gastrointestinal Nursing, 19 Jun 2019; 17(5)
Abstract
Gastrointestinal endoscopy is generally safe, but these diagnostic and therapeutic interventions come with potential risks and thus require written, valid and informed consent, except in emergencies. Informed consent requires patients to receive and discuss information on the benefits, risks and nature of the procedure, as well as any alternatives. To consent, a patient must have the mental capacity to understand the information and use it to make and communicate a decision. Consent is a multi-stage procedure, beginning when endoscopy is first proposed and continuing into the intervention, as patients can withdraw consent during the procedure, whether sedated or not. For high-volume, low-risk procedures, the consent process can be safely delegated to qualified endoscopy nurses, with sufficient and relevant training, knowledge and support from the trust. Nurses competencies and other elements of the consent process should be regularly audited.

The Reading Level of Surgical Consent Forms in Hand Surgery
Original Research
Kevin Mertz, Matthew B. Burn, Sara L. Eppler, Robin N. Kamal
Journal of Hand Surgery Global Online, 19 June 2019
Abstract
Purpose
The average United States adult reads at an eighth-grade reading level. In an effort to ensure that patients understand written medical information, the National Institutes of Health and American Medical Association suggest that patient-directed material be written at a sixth- to eighth-grade reading level. We hypothesized that the mean reading level of surgical consent forms for hand surgery is not at or below an eighth-grade reading level (the suggested maximum from the National Institutes of Health).
Methods
We conducted a retrospective review of consecutive consent forms used for hand surgery patients from 7 hand surgeons at our institution from June, 2017 to October, 2017. Consent forms were reviewed to collect the hand-written portion describing the procedure. We also assessed our institution’s consent form template. This text was assessed for readability and reading level with the following tools: Flesch-Kincaid Grade Level and Flesch Reading Ease. We categorized the procedures written on each consent form by procedure type and then created simplified language for the same procedure below an eighth-grade reading level.
Results
Mean Flesch-Kincaid grade level of all consent forms was 10.5 (SD, 5.8) and mean Flesch readability was 33.6 (SD, 38.8), or difficult to read. A total of 78% and 58% of forms were written above the sixth- and eighth-grade reading levels, respectively. Readability was remarkedly poor; 94% and 88% of consent forms were written above sixth- and eighth-grade readability, respectively. The grade level of the consent form template was 17.1.
Conclusions
Most consent forms were written above a sixth- to eighth-grade reading level and may not have been well-understood by patients. It is possible for physicians to write on surgical consent forms at a reading level that patients are more likely to understand by opting for less specialty-specific words and writing in shorter sentences. Improving the readability of patient-directed materials is an approach to improving patient-centered care.

Informed Consent in Plastic Surgery, Evaluation of its Effectiveness for Mutual Satisfaction of Patient and Doctor: Comparison of Methods
Paolo G. Morselli, Andrea Lippi, Federico A. Giorgini, Erich Fabbri, Valentina Pinto
Journal of Plastic, Reconstructive & Aesthetic Surgery, 5 June 2019
Abstract
Background
The acquisition of signed informed consent is not always enough to ensure adequate medical protection. Particularly in plastic surgery improving the doctor-patient relationship by understanding the patient’s emotions and expectations becomes a determining factor when choosing the best therapeutic strategy for the subject in question, which may also include non-surgical eligibility.
Methods
90 patients, with various plastic surgery disabilities, were recruited and randomly divided into three groups: the 1st group underwent the “traditional” clinical interview, the 2nd to the clinical approach called Shared Decision Making (SDM), the third group received both the SDM and a questionnaire evaluating patient expectations (Expectation Questionnaire-Pgm). At the end of each interview, a specialist physician in Plastic, Reconstructive and Aesthetic Surgery was asked to fill in a questionnaire regarding his/her satisfaction with the method used. Likewise, the patient filled in a questionnaire on his/her satisfaction with the interview.
Results
For the doctors, the third method was superior in investigating patient expectations, emotions and personal preferences. For the patients, the third method score significantly higher than the first one for overall satisfaction, ability to evaluate personal preferences and needs; and higher than the first and second in assessing expectations.
Conclusions
For doctors, the SDM coupled with the Expectation Questionnaire-Pgm proved to be the most useful tool to understand patient expectations and emotions and thus improve the medical-patient relationship through shared decision-taking. The third method therefore makes for better patient coverage and improved informed consent, reducing the likelihood of litigation and better assessing non-fitness for operation.

Consent Obtained by Residents: Informed by the Uninformed?
Tait AR
The Journal of Clinical Ethics, 1 Jan 2019; 30(2) pp 163-166
Abstract
Informed consent is central to the bioethical principle of respect for persons, a process that involves a discussion between the physician and patient with disclosure of information sufficient to allow the patient to make an informed decision about her or his care. However, despite the importance of informed consent in clinical practice, the process is often ritualized, perfunctory, and performed by individuals with little or no training in the consent process. This article discusses the lack of medical students’ and residents’ training in informed consent and questions the practice of allowing untrained residents and surrogates to obtain consent from patients.

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.