Recall of consent information by day care prostate biopsy patients: An assessment of the role of a third-party check
Original Article
II Nnabugwu, FO Ugwumba, EI Udeh, SK Anyimba
Nigerian Journal of Clinical Practice, 11 June 2020
Open Access
Abstract                     
Background: To evaluate the extent of recall of consent information by daycare prostate biopsy patients in our low-literacy setting. And to evaluate the role of a 3rd party check on patient’s recall of consent information. Subjects and Methods: As part of our standard of care, a formal informed consent session for day care prostate biopsy takes place 3 days prior to the procedure. For this study, before leaving the outpatient clinic the same day, the patient acknowledged before a third-party that his concerns were or were not satisfactorily addressed. The extent of recall of consent information was assessed on the morning of the procedure using a researcher-administered questionnaire. Consecutive patients participated in this cross-sectional study for day care prostate biopsy at a tertiary hospital in southeast Nigeria from February to November 2015 after obtaining due consent. Results: The recall of the risks associated with the planned procedure was poorer than the recall of the nature of the disease condition or the nature of the planned procedure. However, it was observed that aggregate recall was significantly poorer among patients who negatively attested to a satisfying consent session (OR 0.125; P < 0.0005). Conclusion: The use of a third-party in determining patient satisfaction after a consent session may be a better indicator of patient comprehension and subsequent recall of consent information, especially in low-literacy settings. Using a third-party, in this manner, may assist in checking paternalism inherent in the patient-doctor relationship.

Women’s experiences of decision-making and informed choice about pregnancy and birth care: a systematic review and meta-synthesis of qualitative research
Research Article
Cassandra Yuill, Christine McCourt, Helen Cheyne, Nathalie Leister
BMC Pregnancy and Childbirth, 10 June 2020; 20(343)
Open Access
Abstract
Background
The purpose of this systematic review (PROSPERO Ref: CRD42017053264) was to describe and interpret the qualitative research on parent’s decision-making and informed choice about their pregnancy and birth care. Given the growing evidence on the benefits of different models of maternity care and the prominence of informed choice in health policy, the review aimed to shed light on the research to date and what the findings indicate.
Methods
a systematic search and screening of qualitative research concerning parents’ decision-making and informed choice experiences about pregnancy and birth care was conducted using PRISMA guidelines. A meta-synthesis approach was taken for the extraction and analysis of data and generation of the findings. Studies from 1990s onwards were included to reflect an era of policies promoting choice in maternity care in high-income countries.
Results
Thirty-seven original studies were included in the review. A multi-dimensional conceptual framework was developed, consisting of three analytical themes (‘Uncertainty’, ‘Bodily autonomy and integrity’ and ‘Performing good motherhood’) and three inter-linking actions (‘Information gathering,’ ‘Aligning with a birth philosophy,’ and ‘Balancing aspects of a choice’).
Conclusions
Despite the increasing research on decision-making, informed choice is not often a primary research aim, and its development in literature published since the 1990s was difficult to ascertain. The meta-synthesis suggests that decision-making is a dynamic and temporal process, in that it is made within a defined period and invokes both the past, whether this is personal, familial, social or historical, and the future. Our findings also highlighted the importance of embodiment in maternal health experiences, particularly when it comes to decision-making about care. Policymakers and practitioners alike should examine critically current choice frameworks to ascertain whether they truly allow for flexibility in decision-making. Health systems should embrace more fluid, personalised models of care to augment service users’ decision-making agency.

Informed consent in obstetrics – a survey of pregnant women to set a new standard for consent in emergency obstetric interventions
Original Article
Tracey E. Sturgeon, Huma Ayaz, Kirsty McCrorie, Kate Stewart
Journal of Obstetrics and Gynaecology, 10 June 2020
Abstract
Informed consent is necessary for all medical, surgical and obstetric interventions. Whilst informed consent can be obtained for elective procedures, it is much more challenging to obtain for emergency interventions. It can be difficult for women to understand the need for emergency intervention when pregnancy has been low risk. This can lead to problems with psychological trauma from the delivery being foremost in their minds in the postnatal period and in future pregnancies. The Montgomery ruling of 2015 encouraged informing women about risks and benefits of interventions and letting the women take responsibility for their own decision-making. Here, a patient-focused survey collected information on pregnant women’s knowledge and wishes regarding emergency interventions. The responses were analysed in relation to local and Scottish national delivery data. We have initiated a novel programme to ensure all of our pregnant women are empowered to give informed consent for emergency interventions.

The effect of positively framing side-effect risk in two different formats on side-effect expectations, informed consent and credibility: A randomised trial of 16-75 year olds in England
R. Webster, G.J. Rubin
Springer Nature, 2 June 2020
Abstract
Background
Reframing side-effect information in patient information leaflets (PILs) in terms of those who remain side-effect free may reduce negative expectations and side-effects, although there are concerns this may impact informed consent. This study compared two versions of positively framed PILs to current practice to see which reduces side-effect expectations whilst maintaining informed consent and credibility.
Methods
We commissioned Ipsos MORI to conduct an online survey of 16-75s in England. 1067 people completed the study and were randomised to receive a PIL for a hypothetical new antibiotic that either communicated side-effects following current practice (n=356), used positive framing with natural frequencies (n=356), or positive framing with percentages (n=355). After reading the leaflet participants completed measures of their side-effect expectations, absolute risk perceptions, and satisfaction and credibility of the leaflet.
Results
Both positively framed PILs resulted in significantly lower side-effect expectations compared to the current PIL for all side-effects (p’s<.001), apart from seizure. Pairwise comparisons showed no difference in side-effect expectations between the two positively framed PILs (p’s>.626). The positively framed PIL using natural frequencies produced more accurate risk perceptions than the same leaflet using percentages; but performed equally to the current PIL. There was no difference between the leaflets in terms of satisfaction with or credibility of the PILs
Conclusion
Positively framed PILs using natural frequencies significantly reduced side-effect expectations and provided the most accurate risk perceptions without impacting satisfaction or credibility. Replication is needed with patients prescribed new medication and those with lower educational status.

The Practice of Obtaining Informed Consent for Elective Surgery and Anesthesia from Patients’ Perspective: An Institutional based Cross-Sectional Study
Tadese Tamire Negash, Aragaw Tesfaw
Research Square, June 2020
Open Access
Abstract
Background
Informed consent is a body of shared decision making process and voluntary authorization of patients to receive medical or surgical intervention. There are limited studies conducted so far to examine the practice of informed consent in Ethiopia. The aim of the study was to assess the practice of informed consent for surgery and Anesthesia from patients’ perspective.
Method
An institutional-based cross-sectional study was conducted from March to May 2019. The data were collected using an interviewer-administered structured questionnaire and entered and analyzed using Microsoft Excel and SPSS version 23.
Results
A total of 139 patients were interviewed in this study. Most 42(30.2%) of patients were in the age group of 29-38 years. The majority 74(53.2%) of the population were females and most 85 (61.2%) were from a rural residence. Nearly half 68 (48.9%) of the patients were informed of the benefits of the surgical procedure and 78(56.1%) of the patients were informed on the type of anesthesia to be administered while 65 (46.8% ) were not informed on any complications related to the anesthesia. About 66 (47.5%) of the patients interviewed were informed on alternatives to the surgery done. Of these patients, 39(59%) were not informed of any benefits and possible risks associated with the alternative modes of treatment. More than half 75 (54%) of the patients reported as they were understood the information provided during the pre-operative counseling and about 114 (82%) of the patients interviewed satisfied with the current process of obtaining informed consent.
Conclusions and recommendation
The current practice of obtaining informed consent addressed only certain aspects of the informed consent component which reflects that patients were inadequately informed on complications related to surgery and anesthesia, alternative forms of treatment and their risks and benefits.

Patient-centered care using a single consent for planned serial procedures
Brenda G. Fahy, Terrie Vasilopoulos, Susan Ford, F. Kayser Enneking
Perioperative Care and Operating Room Management, September 2020; 20
Abstract
Background
The purpose of this study was to measure the satisfaction of patients and families with the use of a single anesthesia consent form for multiple-related treatments and procedures.
Methods
A six-question survey was developed to ascertain the satisfaction of this consent process. Chi-square tests were used to evaluate how responses differed by procedure. P < 0.05 was considered statistically significant.
Results
Fifty-two surveys were obtained with all (100%) aware consent entailed more than one procedure and was preferred. Nearly all respondents (98%) agreed or strongly agreed that they were well informed about the consent process.
Conclusion
In this study, a single consent encompassing multi-related procedures was understood and preferred by patients. This could be applied more broadly for other services when a series of procedures are anticipated as part of the patient’s care plan. There may be opportunity to apply a single consent form for other areas that have a series of planned procedures as part of care (e.g. multi-related surgical procedures).

Analysis of the Influence of Clinical and Demographic Factors on the Understandig of Cataract Informed Consent
Antonio Barreiro-González, Miriam Rahhal-Ortuño, Alex S. Fernández-Santodomingo, Jose I. Bueso-Bordils, Antonio J. Cañada-Martínez, María J. López-Prats, Mercedes Hurtado-Sarrió
Acta Bioethica, 2020; 26(1) pp 91-100
Open Access
Abstract
Purpose: To estimate the influence of clinical and demographical information in the understanding of cataract surgery informed consent, identifying less understandable areas. To assess informed consent document concept. Methods: Multiple-choice questionnaire was designed to collect information and to evaluate the understanding of cataract surgery and informed consent. An ordinary regression model was adjusted to express the effect of clinical and demographic variables to the questionnaire score. Results: The study comprised 180 patients. Sex (female, p=0.404), non-ophthalmologist source of information (p=0.397), previous surgical history (p=0.571), not having a companion (p=0.396) nor the days since the signing of informed consent form (p=0.535) had no influence in the understanding of cataract surgery informed consent. Age (r=-0.083, p<0.001) and educational level (secondary studies r=1.845, p<0.001; tertiary studies r=4.289, p<0.001) showed statistical significance with greater strength of association educational level (OR secondary studies = 6.33, OR tertiary studies = 72.86) than age had (OR = 0.92). Conclusion: Patient’s knowledge about cataract informed consent is influenced by age and educational level. The purpose and the risks, consequences of not performing surgery and postoperative indications are the least understood topics. Informed consent is seen as a forced legal obligation.