Patient Satisfaction with Informed Consent for Cesarean and Operative Vaginal Delivery
Karen S. Levy, Martha K. Smith, Meagan Lacroix, Mark H. Yudin
Journal of Obstetrics and Gynaecology Canada, 29 March 2022
Abstract
Objective
To evaluate patient satisfaction with the informed consent process for elective cesarean delivery (CD), emergency CD, and operative vaginal delivery (OVD).
Methods
A cross-sectional, survey-based study was conducted among patients on the postpartum floor of our institution. Patients were approached after delivery to complete a previously pilot-tested questionnaire, based on validated literature. One hundred eighty-four surveys were included in the analysis. Levels of patient satisfaction were compared across modes of delivery using χ2 tests of independence. Secondary objectives included evaluating the relationship between satisfaction scores and the patient’s recall of the consent process and emotional state during the consent process.
Results
A significant association was found between patient satisfaction with the consent process and mode of delivery (P < 0.001). Those in the elective and emergency CD groups were significantly more likely to express high rates of satisfaction compared with those in the OVD group (odds ratio [OR] 9.03; 95% CI 2.80–29.10 and OR 3.97; 95% CI 1.34–11.76, respectively). High levels of satisfaction were significantly more common among those who had greater recall of the consent process (OR 25.2; 95% CI 7.34–87.04) and those who reported low levels of distress during the process (OR 15.1; 95% CI 4.70–48.66).
Conclusion
Informed consent during OVD is associated with lower rates of patient satisfaction compared with CD. Efforts are needed to improve the consent process for OVD to increase patient satisfaction and promote patient-centred care.

The Consent Process for Elective Hip and Knee Arthroplasty: Does Information on Handwritten Forms Meet Prescribed Standards?
Anirudh Sharma, Osasumwen Adelowo, Santosh Bindumadhavan, Naufal Ahmed, Amir-Reza Jenabzadeh
Cureus, 28 March 2022; 14(3)
Abstract
Introduction
The process of informed consent is vital, not only to good clinical practice and patient care, but also to avoid negligence and malpractice claims. Elective hip and knee arthroplasty numbers are increasing globally, and the British Orthopaedic Association (BOA) has endorsed standards for obtaining written consent for these procedures. Many centres in the United Kingdom and globally, use handwritten consent forms to document informed consent, leaving open the potential for missing out important procedure and risk-related information. Our study aimed to assess whether information on handwritten consent forms was compliant with BOA standards for elective arthroplasty of the hip and knee.
Methods
We retrospectively reviewed 70 handwritten consent forms, across theatre lists of 12 arthroplasty consultants at our elective arthroplasty centre. These included 35 forms each for hip and knee arthroplasty respectively. We compared the information on these forms to the standards prescribed by the BOA. We assessed compliance of the forms with common, less common and rare risks of hip and knee replacement, as described by the BOA. We also noted the designation of the person filling out the form (consultant, registrar or nurse practitioner) and whether this affected information on the form. We assessed the forms for legibility issues, and whether the setting (clinic/pre-operative ward) affected information on the form.
Results
None of the 70 forms reviewed achieved full compliance with BOA standards. When assessed for common risks of hip and knee arthroplasty, the number of compliant forms was 25.7% and 42.8%, respectively. None of the forms mentioned all rare risks of either hip or knee arthroplasty. We identified legibility issues in 12 of 70 (17.1%) forms. There was no significant difference in information written on forms filled out by consultants, registrars or nurse practitioners, or between forms filled out in the clinic versus those on the pre-operative ward.
Conclusion
Handwritten forms lack compliance with prescribed standards for written informed consent in elective hip and knee arthroplasty. Ideally, a pre-written consent form should be used, but with the option of adding information individually tailored to the patients’ background. This ensures that good clinical practice is optimally followed, and reduces the potential risk of any litigation.

Informed Consent is Poorly Documented when Obtaining Toxicology Testing at Delivery in a Massachusetts Cohort
Kathleen J.Koenigs, Joseph H. Chou, Samuel Cohen, Moira Nolan, Gina Liu, Mishka Terplan, Brian M. Cummings, Timothy Nielsen, Nicole A. Smith, Joseph Distefano, Sarah N. Bernstein, Davida M. Schiff
American Journal of Obstetrics & Gynecology MFM, 27 March 2022
Abstract
Background
Positive toxicology testing at delivery can have enormous consequences for birthing persons and their families, including charges of child abuse/neglect and potential loss of custody for the birthing parent. State and national guidelines therefore stipulate clinicians should obtain consent prior to toxicology testing at delivery.
Objective
We examined: (1) clinician documentation of patient consent for peripartum toxicology testing and (2) the extent to which patient and hospital characteristics were associated with documented consent.
Study Design
Retrospective cohort of individuals who underwent toxicology testing within 96 hours of delivery between April 2016 and April 2020 at five affiliated hospitals across Massachusetts. Medical records were reviewed for documentation of: clinician intent to obtain maternal toxicology, testing indication, verbal consent to testing, and child protective services involvement. Hierarchical multivariable logistic regression was used to examine the association between patient and hospital characteristics and documentation of verbal consent.
Results
Among 60,718 deliveries, 1562 maternal toxicology tests were obtained. Verbal consent for testing was documented in 29.8% of cases (n=466). Documented consent was lacking across most demographic groups. Consent was no more likely to be documented when a report was filed with child protective services, and less likely in cases where the birthing parent lost custody prior to discharge (p=.003). In our multivariable model, consent was least likely to be documented when a maternal complication (abruption, hypertension, preterm labor, preterm premature rupture of membranes, intrauterine fetal demise) was the indication for testing (aOR, 0.46; CI, 0.28 to 0.76). Verbal consent was twice as likely to be documented in delivery hospitals with established consent policies (aOR, 2.10; CI, 1.01 to 4.37).
Conclusion
Consent for toxicology testing at delivery appears to be infrequently obtained based on clinician documentation. Provider education and hospital policies for obtaining informed consent are needed to protect the rights of birthing individuals.

More Needs to Be Done During the Informed Consent Process
Case Report
Rashed Alfuzaie
Cureus Journal of Medical Science, 20 March 2022; 14(3)
Abstract
Retinal detachment is an emergency commonly encountered in ophthalmic practice. In this article, a reflection about the ethical implications surrounding the informed consent process of retinal detachment repair is presented. We look at how premade informed consent forms allow for a better patient understanding of their condition, the procedure they are due to undergo, their postoperative course, and the potential complications they might face, hence potentially improving the overall outcome.

An overview and top tips for gaining informed consent for DCPs
Feature
Rana Fard, Keerut Oberai
BDJ Team, 18 March 2022; (9) pp 20-22
Introduction
In the past, dental ethics was based on a paternalistic ‘doctor knows best’ approach. Accordingly, dental care professionals (DCPs) would decide what is in the patient’s best interest in terms of their treatment and the patient would have minimal input. Over the last 50 years, we have moved away from this approach to one which is focused on the concepts of autonomy and consent. Today, instead of the patient being a passive subject, they are at the centre of any decision which relates to their general and oral health. In addition, these are made in partnership with their DCP who has a duty to ensure that the key components of informed consent are met…

How important are informed consent, informed choice, and patient-doctor relationships, when prescribing antipsychotic medication?
Article
Journal of Mental Health, 8 March 2022
Abstract
Background
Antipsychotic medications (APs) are used for people with psychosis diagnoses and, increasingly for other problems and groups.
Aims
This study examines how APs are prescribed, from the perspective of recipients.
Methods
757 people, from 30 countries, responded to questions about their experiences with APs in an online survey.
Results
Most (70%) were told nothing about adverse effects. Fewer than 2% recall being told about the risks of diabetes, suicidality, sexual dysfunction or reduced life span. None recalled being told about reduced brain volume or withdrawal effects. Only 28% recalled being offered other treatments; with only 14% offered talking therapies. 46% were not told how long to take the APs; and, of those, 48% were told to take them forever. Most respondents (76%) were not told how APs work. Only 19% were satisfied with the prescribing process, and only 25% reported a good, or very good, relationship with the prescriber. Information, satisfaction with the process and prescriber relationship were all positively related to three self-reported outcomes: reduction of problems the drugs were prescribed for, general helpfulness, and quality of life.
Conclusions
Steps need to be taken to ensure people prescribed antipsychotics are fully informed, especially about adverse effects and alternatives.

Utilizing the “teach-back” method to improve surgical informed consent and shared decision-making: a review
Review
Kevin D. Seely, Jordan A. Higgs, Andrew Nigh
Patient Safety in Surgery, 5 March 2022; 16(12)
Open Access
Abstract
The teach-back method is a valuable communication tool that can be employed to improve patient safety and shared decision-making. Its utility in patient care has been studied extensively in many areas of clinical medicine. However, the literature on the use of teach-back in surgical patient education and informed consent is limited. Additionally, there is some ambiguity about the functional definition and performance of the teach-back method in the literature, consequently rendering this valuable tool an enigma. This review examines the current standards and ethics of preoperative informed consent and provides a concise, actionable definition of teach-back. The manner in which teach-back has been implemented in medicine and surgery is then examined in detail. Studies analyzing the use of teach-back in medicine have demonstrated its effectiveness and benefit to patient care. Further study on the use of teach-back to improve preoperative informed consent is supported by the few preliminary trials showing a positive effect after implementing the teach-back method in critical patient interactions.

Informed consent for stochastic effects of ionising radiation in diagnostic imaging
Commentary
Richard Mendelson
British Journal of Radiology, 24 February 2022
Abstract
The ethical and legal principles underpinning the requirement for informed consent for medical procedures are widely accepted. A recent BJR article has applied these principles to the issue of consent to ionising radiation (IR) from diagnostic imaging (DI), but the authors chose to put aside the practical problems associated with this. These problems should not be underestimated and arise from: uncertainties about the existence and magnitude of risk of stochastic effects of IR exposure in DI; the delayed manifestation of its effects; the heterogeneity of risk related to factors associated with individual sensitivity to IR, and dose variation even within examination classes and across clinical indications; and the difficulty of communication of these uncertainties and variations to patients. This article discusses these practical issues associated with consent for IR in DI.

A study of adequacy of informed consent before caesarean section in a tertiary care hospital
Nishu Bhushan, Aakriti Manhas
International Journal of Reproduction, Contraception, Obstetrics and Gynecology, February 2022; 11(2)
Abstract
Background
Informed consent is an ethical and legal requirement and is practiced before all the surgical procedures. Caesarean section is the commonest obstetric surgery so, this study was aimed to assess the adequacy of informed consent in patients who underwent caesarean section at SMGS Hospital, GMC, Jammu.
Methods
A cross-sectional study was done. A total of 230 patients were included in the study. A pre-tested and pre-validated questionnaire was used for the study. The data were expressed as percentage of proportion.
Results
230 patients participated in the study. About 96.95% patients knew the name of the procedure. 91.73% patients were informed about the indication of the surgery. 95.21% of the patients were aware about the benefits of surgery and about 93.41% of the patients were knowing risks of surgery. About 83.04% patients were informed about the procedure of the surgery. About 94.78% and 94.34% of the patients were aware about the need for the blood transfusion and future pregnancy options. Only about 4.35% of the patients were informed about the requirement and type of anaesthesia. 22.18% of the patients knew about the choice for alternate procedure and merely 2.18% of the patients were informed about the right to refuse the procedure.
Conclusions
It was found that majority of the patients were well informed about the procedure and the related consequences. Still we can improve some elements of the consent process which can be done by proper awareness and training of health care professionals.

Shared decision making and surgical informed consent in general surgery: A pilot study on differences in perspectives of physicians and patients [BOOK CHAPTER]
Wouter K.G. Leclercq, Willem Zwaans, Loes Janssen, Johan Legemaate, Laurents P.S. Stassen, Marc R. Scheltinga
Máximazing the quality of perioperative patient counselling: Surgical informed consent and postoperative e-health in present day surgical care, 2021; Chapter 7 [Maastricht University]
Open Access
Abstract
Introduction
Shared decision making (SDM) and surgical informed consent (SIC) are increasingly recognized as important aspects of preoperative consultation in general surgery. Different perspectives of physicians and patients may result in suboptimal levels of communication, expectations and knowledge exchange. Goal of this study is to assess the quality of, and relation between, SDM and SIC in a general surgery outpatient department.
Methods
Randomly selected surgical patients completed a questionnaire concerning SDM aspects of their preoperative consultation (SDM-Q-9). Their surgeons completed the doctor’s version termed SDM-Q-Doc. SDM-Q-9 and SDM-Q-Doc scores (0-100), and SIC scores based upon the medical record (0-10) were calculated and analysed using standard statistical methods, including calculation of intraclass correlation coefficients (ICC).
Results
A total of 38 sets of both SDM-Q-9 and SDM-Q-Doc questionnaires were available for analysis. Median total SDM-Q-9 scores were higher than SDM-Q-Doc scores (90 vs. 79, P<0.05). Significant differences were found in 3 of 9 items of the patient’s and surgeon’s SDM questionnaires. SIC scores were low (4.1±1.3). Correlations between SDM-Q-9, SDM-Q-Doc and SIC scores were low (all ICCs <0.1).
Discussion
This pilot studying both shared decision making (SDM) and informed consent (SIC) in a surgical outpatient department indicates an imbalance in expectations between surgical patients, their surgeons and consent recordings. Future initiatives should be aimed at reducing this imbalance to optimize the physician-patient relationship with respect to legal standards.