Clinical Trials Informed Consent: An educational intervention to improve nurses’ knowledge and communications skills
Eileen Regan
Clinical Journal of Oncology Nursing, December 2018; 22(6):E152–E158
Background
Teach-back is an evidence-based tool recommended for use during informed consent (IC) discussions. The nurses’ role in the IC process is important, particularly for patient education and advocacy.
Objectives
The aim was to initiate and evaluate an educational program for nurses to improve knowledge and communication skills used in IC for cancer clinical trials.
Methods
An educational program was presented to nurses. Anonymous pre-, post-, and one-month postprogram surveys measured nurses’ knowledge of research and the importance of and confidence using teach-back during IC discussions.
Findings
Nurses had high research knowledge scores and statistically significant improvement in pre- and post-test scores of conviction and confidence using teach-back. Nurses employed essential elements of teach-back before the program but had greater recognition of elements after the program.

Informed Consent, Fraud and Confidentiality in Psycho-Pedagogic Research Activity
Corina Iurea
Jus et Civitas, 2018
Abstract
This paper analyses the ethical character of the interactions between researchers and the subjects of the psycho-pedagogic research, a topic that has attracted more and more interest. The research activity needs to be ethical, show consideration towards the interests and needs of the participants and of those affected by the research results. While researching, we need t be honest, opened, and have a critical approach about who, what and why we perform the research. Researchers need to avoid any activity that could impact their credibility, objectivity, and impartiality.

Informed consent for endoscopic procedures in Portugal–do we need a thoroughly detailed consent form?
N Almeida, M Areia, C Chagas, R Cardoso, M Dinis-Ribeiro
Endoscopy, 29 January 2019; 51(02) pp 200-201
Abstract
Endoscopy is an invaluable tool for all Gastroenterologists but most importantly it is a crucial procedure/method in screening, diagnosis and management of gastrointestinal diseases which in turn affect a relevant proportion of citizens. The number and technical difficulty of endoscopic procedures have greatly increased in the past two decades, and even the simpler ones are not purely diagnostic examinations which are exempt from risks [1]. A small but real risk is present in all endoscopic procedures, even if there are no additional diagnostic (e. g., biopsies) or therapeutic manoeuvres (such as polypectomy)

Adverse event rate for upper endoscopy ranges from 1 in 200 to 1 in 10,000 and mortality ranges between none to 1 in 2,000 [2] [3]. Curiously, up to 2.5 % of patients sought medical advice for various complaints following upper endoscopy [4]. For colonoscopy the risks are higher and a systematic review including 57,742 colonoscopies performed for screening in average risk patients showed a pooled serious adverse event rate of 2.8 per 1,000 procedures [5]. Classically, the most feared one is perforation with rates of 0.019 to 0.8 % in diagnostic and 0.10 to 3 % in therapeutic colonoscopies [6]. Such rate is expected to increase with widespread acceptance of colonoscopy screening [7]. Even so, a recent study, from a bowel cancer screening programme, revealed a perforation rate of 0.06 % (1 in 1,790 procedures) [8]. However, it is interesting to notice that only 13 % of such perforations were detected during colonoscopy and morbidity was considerably higher in the remainder 87 % [8].

Owing to the invasive nature and potential risks of all endoscopic procedures of the gastrointestinal tract, written consent should be formally obtained, except in an emergency [9]. In Portugal, there are written instructions about the informed consent, and an online formulary from the Ministry for Health, Health Authority [10]. However, such formulary is awkward, difficult to fill out, and most Gastroenterology Departments and Clinics have their own written informed consents with specific information about the proposed procedures.

Traditionally, it is recommended that verbal and/or written information should be provided to all patients referred for endoscopic procedures [9] [10]. Such information must be in a format that allows the patient to understand the expected benefits as well as the potential burdens and risks and alternatives [9]. This means the patient must be informed not only about the most common risks, but also about the most serious, albeit rare, ones. But there are specific risks in specific individuals. So, should we provide a generic, easy to read and understandable information or go for a detailed version, including all risks and specific circumstances that can increase complication odds?

Our Supreme Court condemned recently a Gastroenterologist to pay a civil indemnification to a patient that suffered a perforation during a colonoscopy. The court assume as proven that the patient was informed about the proposed procedure, including the risk of perforation, and the doctor acted in accordance with the leges artis. However, since the patient had a history of previous abdominal surgery and was not informed that such fact increases the risk of perforation the informed consent procedure was considered not valid. This represents a major alert to all Portuguese Gastroenterologists and probably we need a more detailed informed consent form for all endoscopic procedures. The Portuguese Society of Digestive Endoscopy is working to provide specific written leaflets to our associates. The texts are being discussed with counsellors from the Centre for Biomedical Law at the Faculty of Law, University of Coimbra and will go for public discussion in a short period of time.

We are facing a potentially turbulent period in our relationship with the rest of society, but we must give our best efforts to help all our patients! That is the only reason to perform these procedures as they currently exist, and, most of all, to innovate and develop them.

Improving surgical informed consent in obstetric and gynaecologic surgeries in a teaching hospital in Ethiopia: A before and after study
Million Teshome, Zenebe Wolde, Abel Gedefaw, Anteneh Asefa
BMJ Open, 25 January 2019
Open Access
Abstract
Objectives 
Even though surgical informed consent (SIC) has marked benefits, in many settings the information is not provided appropriately. In Ethiopia, minimal attention is given to SIC. This study assesses whether an intervention designed to improve SIC in obstetric and gynaecologic surgeries is associated with receipt of SIC components.
Design 
Pre-intervention and post-intervention surveys were conducted at Hawassa University Comprehensive Specialized Hospital among women who underwent obstetric or gynaecologic surgeries. The intervention consisted of a 3-day training on standard counselling for surgical procedures offered to health professionals. A total of 457 women were surveyed (230 pre-intervention, 227 post-intervention). An adjusted Poisson regression analysis was used to identify the association between the intervention and the number of SIC components received.
Results 
The majority of participants were 25–34 years of age in both the pre-intervention and post-intervention groups (p=0.66). 45.7% of the pre-intervention and 51.5% of the post-intervention survey participants underwent elective surgery (p=0.21). Additionally, 70.4% of pre-intervention survey participants received counselling immediately before surgery, compared with 62.4% of post-intervention participants (p<0.001). 5.7% of pre-intervention and 6.6% of post-intervention participants reported the belief that SIC consists entirely of signing on a piece of paper (p=0.66). After controlling for effects of potential confounders, the number of SIC components reported by post-intervention survey participants was 16% higher than what is received by pre-intervention ones (adjusted coefficient=1.16 (1.06–1.28)). Having elective versus emergency surgery was not associated with the number of components received by participants in either group (adjusted coefficient=0.98 (0.88–1.09)).
Conclusion 
Training on the delivery of standard SIC is associated with receipt of a higher number of standard counselling components. However, there is a need to evaluate whether a one-time intervention leads to sustained improvement. A system-wide study of factors that promote SIC is required.

How to effectively obtain informed consent in trauma patients: a systematic review
Yen-Ko Lin, Kuan-Ting Liu, Chao-Wen Chen, Wei-Che Lee, Chia-Ju Lin, Leiyu Shi, Yin-Chun Tien
BMC Medical Ethics, 23 January 2019; 20(8) 
Abstract
Background
Obtaining adequate informed consent from trauma patients is challenging and time-consuming. Healthcare providers must communicate complicated medical information to enable patients to make informed decisions. This study aimed to explore the challenges of obtaining valid consent and methods of improving the quality of the informed consent process for surgical procedures in trauma patients.
Methods
We conducted a systematic review of relevant English-language full-text original articles retrieved from PubMed (1961–August 2018) that had experimental or observational study design and involved adult trauma patients. Studies involving informed consent in clinical or research trials were excluded. Titles and abstracts of searched articles were reviewed and relevant data were extracted with a structured form. Results were synthesized with a narrative approach.
Results
A total of 2044 articles were identified in the initial search. Only eight studies were included in the review for narrative synthesis. Six studies involved orthopedic surgeries, one involved nasal bone surgeries, and one involved trauma-related limb debridement. Only one study was conducted in an emergency department. Information recall was poor for trauma patients. Risk recall and comprehension were greater when written or video information was provided than when information was provided only verbally. Patient satisfaction was also greater when both written and verbal information were provided than when verbal information alone was provided; patients who received video information were more satisfied than patients who received written or verbal information.
Conclusions
Many articles have been published on the subject of informed consent, but very few of these have focused on trauma patients. More empirical evidence is needed to support the success of informed consent for trauma patients in the emergency department, especially within the necessarily very limited time frame. To improve the informed consent process for trauma patients, developing a structured and standardized informed consent process may be necessary and achievable; its effectiveness would require evaluation. Adequately educating and training healthcare providers to deliver structured, comprehensive information to trauma patients is crucial. Institutions should give top priority to ensuring patient-centered health care and improved quality of care for trauma patients.

Informed Consent Education in Obstetrics and Gynecology: A Survey Study
Katie Propst, David M.O’Sullivan, Amanda Ulrich, Elena Tunitsky-Bitton
Journal of Surgical Education, 2 January 2019; 76(1)
Abstract
Objective
The practice of obstetrics and gynecology poses specific ethical challenges for informed consent (IC). Data regarding resident confidence with the IC process are lacking. Our objective was to evaluate obstetrics and gynecology residents’ education, experience, and confidence related to IC.
Design
This was a cross-sectional survey of obstetrics and gynecology residents. Descriptive analyses were performed using mean and standard deviation or frequency expressed as a percentage. The results were analyzed for statistical significance using chi-square or Fisher’s exact tests for categorical variables and Student t or Mann-Whitney U tests, as appropriate, for continuous variables; all results yielding p < 0.05 were deemed statistically significant.
Results
Two hundred eighty-one trainees completed the survey. The majority of participants were female (84.3%) and from an academic training program (65.1%). Two hundred seventy-seven trainees (98.6%) reported that they had obtained IC for operating room procedures; the majority had first done this in the first postgraduate year (PGY) (n = 258, 91.8%). Trainees most commonly obtain IC for resident and general gynecology attending cases. Most trainees primarily learn how to obtain IC via observation of their coresidents and attendings. Nearly 90% of trainees have obtained IC for a procedure for which they were unsure of all the risks. One hundred seventy-three trainees (61.6%) reported that they would like to have more training in IC. Increasing PGY was significantly associated with increasing confidence in obtaining IC for gynecologic, obstetric, and office procedures (all p < 0.01). There were no differences based on PGY in frequency of reviewing who will perform the surgical procedure (p = 0.75), how trainees will be involved in the procedure (p = 0.35), review of alternative treatments (p = 0.91), or in documentation of the IC process (p = 0.16).
Conclusion
Based on the findings of this survey study, education related to the IC process is warranted and curriculum development should be the focus of future study.

Quality of informed consent as experienced by patients awaiting surgical intervention in a tertiary care setting in Sri Lanka
Gunathunga, M.H.D.; Hansamali, M.M.P.; Hapuarachchi, H.S.M.; Herath, H.M.T.H.; Herath, H.M.C.J.; Chandratilake, M.N.
Proceedings of the Sri Lanka Medical Association, Anniversary Academic Sessions, 2018; 63(21)
Abstract
Introduction and Objectives
Informed consent is a basic ethical principle. The existing guidelines may not be fully operational in practice. The objective of this study was to identify the common lapses in obtaining informed context
Methods
A cross-sectional descriptive study was conducted in surgical wards of North-Colombo Teaching Hospital. A questionnaire was developed by observing 11 consent-taking encounters. 100 in-ward patients awaiting surgical interventions completed the questionnaire.
Results
We observed that the information regarding surgery is provided by different personnel along the process. The gap between information provision and consent taking appeared inadequate for patients to take a well thought-out decision. In most instances, consenting was given by signing/thumb-printing a statement prescribed by the intern house officer. Disturbances to the process of doctor-patient conversation were also observed and privacy was a concern as the setting for doctor-patient conversation was not in an acceptably private space. According to patients, information provision (48% in the clinic; 43% of the time by senior doctors) and expressing (100% in the ward; 86% of the time by most junior doctors and 10% by nurses) have happened as two disjointed processes. Common lapses identified by patients were: alternative treatment options were not explained (85%); a tendency not to discuss risks (50%); confinement to verbal explanation (87%); and not requesting patients to paraphrase to check their understanding (90.9%).
Conclusion
There were lapses in consent-taking procedure which were largely attributable to poor patient centeredness and respect for patients’ autonomy among doctors, and the power gap between patients and doctors.