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.

Informed consent in gynecologic surgery
Patricia Overcarsh, Cynthia Arvizo, Lara Harvey
Current Opinion in Obstetrics and Gynecology, 30 April 2019
Abstract
Purpose of review 
Informed consent is frequently used interchangeably with obtaining a signature on a form. This oversimplification shifts the value from the process of informed consent to the documentation. This review focuses on the recommended components of the consent process, barriers encountered, factors influencing patient satisfaction, attempts to improve the consent practice, and considerations in special populations.
Recent findings 
The process of informed consent is key to promoting shared decision-making and patient autonomy. Several barriers exist to providing optimal consent including time constraints as well as educational, cultural, and language barriers. Innovative approaches such as audiovisual aids show promise in overcoming barriers and improving the consent process.
Summary 
Patients seek expertise and knowledge to aid in making decisions that align with their care goals. Providers have an obligation to provide individualized and accessible counseling. Ongoing research is needed to optimize this process.

Informed Consent For Anaesthesia: Are Our Patients Well Informed?
H Y Embu, M G Yilkudi, S I Nuhu
Journal of Biomendical Research & Clinical Practice, 4 April  2019; 2(1)
Abstract
Patients have the right to be properly informed about procedures to be undertaken on them so that they could make informed decisions. This study was done at the Jos University Teaching Hospital and the University of Abuja Teaching Hospital. Questionnaires on informed consent were administered postoperatively on patients who had undergone elective surgeries under various forms of anaesthesia. The questionnaires sought to find out how much information patients were given about their anaesthesia and how satisfied they were with the information given. 148 patients were interviewed. The mean age was 34.8±13.8 years and the male: female ratio was 1:1.8. Ninety-eight (66.22%) of the procedures were done under general anaesthesia and 50(33.78%) under regional anaesthesia. 104 (70.27%) were told about the type of anaesthesia to be used. Thirty-eight (25.68%) were not told of the possible side effects. Eighty-six (58.1%) understood the information given. 131(88.51%) believed it was necessary to be given information about the anaesthesia. Postoperative pain management was discussed with 10 (6.76%) of respondents. 104 (70.27%) expressed satisfaction with the information given. Information about anaesthesia was given by residents in anaesthesia in 62.16% of cases, by consultant anaesthetists in 8.78% cases, by surgeons in 10.81% of cases and by house officers and nurses in 14.19% of cases. Majority of patients would like information about their anaesthesia procedures but were inadequately informed. Consent for anaesthesia is often obtained by junior residents who have had little training in this aspect. Training on informed consent should be part of the residency program.

Barriers and pathways to informed consent for ionising radiation imaging examinations: A qualitative study
C.W.E.Younger, S.Moran, C.Douglas, H.Warren-Forward
Radiography, 2 April 2019
Abstract
Introduction
Informed consent for ionising radiation medical imaging examinations represents a recent change to medical imaging practice. This practice has not had a definitive and authoritative integration into clinical practice, and lack of direction has caused many health care professionals to be unsure of an appropriate consent methodology. Consent practices have been undertaken inconsistently and sometimes poorly. This research sought to investigate what barriers exist to meaningful informed consent, and what pathways are suggested to overcome these barriers. These views are then discussed in the context of practical health care consent practices.
Methods
A semi-structured interview explored the views of radiographers and radiologists on the practice of disclosing the ionising radiation risk of a clinical medical imaging examination. Qualitative data was analysed using a nominal method of quantitative transformation. Responses were reviewed, and a set of definitive themes constructed. Participants considered the influences, logistics and barriers to the informed consent process. Participants were then asked what pathways might be developed that would improve the process.
Results
Twenty-one (21) radiographer participants and nine (9) radiologists were interviewed. The barriers to consent identified issues of time constraints, lack of a unified message, and patient presentations. Pathways suggested included limiting the scope of the consent practice, sharing the consent responsibility, and formulation of definitive consent guidelines.
Conclusion
A unified, definitive series of guidelines for informed consent for ionising radiation examinations would alleviate many of the identified barriers. Having the consent process consistently begin with the referring doctor would facilitate more meaningful consent.

Does using anatomical models improve patient satisfaction in orthopaedic consenting? Single-blinded randomised controlled trial
K.Sugand, H.H.Malik, S.Newmana, D.Spicer, P.Reilly, C.M.Gupte
The Surgeon, 1 April 2019
Background
Patient satisfaction in consenting is a major pillar of clinical governance and healthcare quality assessment. The purpose was to observe the effect of using 3D anatomical models of knee and shoulder joints on patient satisfaction during informed consent in the largest single-blinded randomised controlled trial in this field.
Methods
52 patients undergoing elective knee or shoulder surgery were randomised into two groups when being consented. The intervention group (n = 26) was shown an anatomical model of the knee/shoulder joint while the control group (n = 26) was given only a verbal explanation without a model. Patients rated their satisfaction on the validated Medical Interview Satisfaction Scale (MISS-26) questionnaire. Semi-structured interviews were analysed for specific themes to determine key factors that influenced patient satisfaction. The mean score ±SD were calculated with significance set at p < 0.05.
Results
There was a significant difference in the overall satisfaction between the control and intervention cohorts (MISS-26 score 4.33 [86.6%] ± 0.646 vs 4.70 [94.0%] ± 0.335 respectively, 7.4% improvement, 8.5% difference, p = 0.01). Behavioural criteria showed a 13% increase in satisfaction (p = 0.02). Semi-structured interviews determined that the factors influencing satisfaction included the surgeon’s interpersonal manner, the use of the visual aid and seeing the consultant surgeon in clinic. All patients in the intervention cohort identified factors contributing to their satisfaction, whereas a fifth of the control cohort claimed nothing at all made them feel satisfied.
Conclusion
Anatomical models as visual aids significantly increased patient satisfaction during the consenting process and played an integral part of the surgeon’s explanation. Patients exposed to anatomical models also claimed to be more satisfied with the surgeon’s inter-personal skills. This study recommends the use of anatomical models, which are both cost-effective and easily implementable, during explanation and consent for orthopaedic procedures.

Incorporating fetal archival tissues into undergraduate medical education
Kaylin Jeanne Beiter, Sophie Elise Fourniquet, Jason C Mussell
Federation of American Societies for Experimental Biology, 1 April 2019; 33(1)
[The bolded sections have been added by the editor]
Abstract
Purpose
A great deal of time is spent in undergraduate medical education preparing students for death and also the importance of informed consent. Missing from these preparations are the differences students may feel when encountering the death of an elderly individual versus the death of an infant and how the different informed consent processes came to be. Purposeful incorporation of fetal specimens in at various time points throughout the first year may be able to help solve these problems simultaneously.
Methods
The Louisiana State University Health Sciences Center at New Orleans (LSUHSC-NO) has in its possession a large repository of fetal specimens, many of which were collected prior to the era of IRB protocols, preventing informed consent from being secured for their use. These fetal specimens are used in anatomy education at LSUHSC-NO annually. We identified appropriate time points throughout the first year of training to insert discussions of informed consent and to examine emotions coincident with dealing with fetal and neonatal death and how they might contrast to student emotions about their cadavers, i.e. adult death, as well as how these feelings evolve over the year. Thematic analyses of self-reflections were used to assess differences in students emotions when confronting death. They will also be used to examine changes in student attitudes regarding death during the entire first year.
Results
Using archival material as the centerpiece for principled discourse challenges students to contextualize the practice of medical ethics socially and historically, heightening awareness of their own cultural and social biases. This experience also provided an outlet for students to share their thoughts on the ethical principles that will guide their future practice and to share their emotional reactions to the fetal specimens. Preliminary results showed themes of anxiety and reverence predominating before students entered the adult cadaver lab while sadness, informed consent, and impropriety predominated student reflections before exposure to fetal specimens.
Conclusions
Providing medical students with an example thought process allows students to begin developing their own methods of incorporating respectful pragmatism into their own careers. Incorporation of fetal collections and discussions of their origins enables undergraduate medical students to think critically and examine their own ethical mores in addition to mastering high volumes of content knowledge.

Informed consent in spinal surgery
V. Todd, N. C. Birch
The Bone & Joint Journal, 31 March 2019; 101B(4) pp 355-360
Abstract
Informed consent is a very important part of surgical treatment. In this paper, we report a number of legal judgements in spinal surgery where there was no criticism of the surgical procedure itself. The fault that was identified was a failure to inform the patient of alternatives to, and material risks of, surgery, or overemphasizing the benefits of surgery. In one case, there was a promise that a specific surgeon was to perform the operation, which did not ensue. All of the faults in these cases were faults purely of the consenting process. In many cases, the surgeon claimed to have explained certain risks to the patient but was unable to provide proof of doing so. We propose a checklist that, if followed, would ensure that the surgeon would take their patients through the relevant matters but also, crucially, would act as strong evidence in any future court proceedings that the appropriate discussions had taken place. Although this article focuses on spinal surgery, the principles and messages are applicable to the whole of orthopaedic surgery.