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.

Consensus on Language for Advance Informed Consent in Health Care–Associated Pneumonia Clinical Trials Using a Delphi Process 
Original Investigation
Amy Corneli, Sara B. Calvert, John H. Powers III, Teresa Swezey, Deborah Collyar, Brian Perry, John J. Farley, Jonas Santiago, Helen K. Donnelly, Carisa De Anda, Katelyn Blanchard, Vance G. Fowler Jr, Thomas L. Holland
JAMA, 22 May 2020
Open Access
Abstract
Importance
Information to be included in advance informed consent forms for health care–associated pneumonia treatment trials remains to be determined.
Objective
To identify and determine how to describe information to be included in an advance informed consent form for an early-enrollment noninferiority hospital-acquired and/or ventilator associated bacterial pneumonia (HABP/VABP) clinical trial.
Design, Setting and Participants
A Delphi consensus process with stakeholders in HABP/VABP clinical trials was conducted using qualitative semistructured telephone interviews from June to August 2016, followed by 2 online surveys, the first from April to May 2017, and the second from September to October 2017. All stakeholders who participated in the interview were invited to participate in the first survey. Stakeholders who participated in the first survey were invited to participate in the second survey. Stakeholders were patients at risk of pneumonia, caregivers, representatives of institutional review boards, investigators, and study coordinators.
Main Outcomes and Measures
Description and consensus of information to be included in advance informed consent forms for early enrollment in noninferiority HABP/VABP clinical trials.
Results
Suggestions from 52 stakeholders about what key informed consent concepts to include and how to explain them were used to create 3 categories to be included in an advance consent form: (1) reassurances on patient health and treatment, (2) rationale for advance consent and early enrollment, and (3) an explanation of noninferiority. At the end of the Delphi process, at least 80% consensus was reached among the 40 stakeholders who participated in the second online survey on each of the statements to include in the proposed consent text. Throughout the process, however, describing and reaching consensus on statements about noninferiority was more problematic than the other categories.
Conclusions and Relevance
The stakeholders endorsed consent language to be used in combination with a strategy for enrolling patients at highest risk for pneumonia before infection onset. Data-driven consent language may help potential participants make informed decisions about their involvement in clinical research and improve enrollment rates, which are necessary to evaluate new treatments and improve patient care. The proposed consent language may be adapted for other trials using an early enrollment strategy and for noninferiority trials.

An instrument for assessing the quality of informed consent documents for elective procedures: development and testing
Original Research
Erica S Spatz, Lisa G Suter, Elizabeth George, Mallory Perez, Leslie Curry, Vrunda Desai, Haikun Bao, Lori L Geary, Jeph Herrin, Zhenqiu Lin, Susannah M Bernheim, Harlan M Krumholz
BMJ Open: Ethics, 19 May 2020; 10(5)
Open Access
Abstract
Objective
To develop a nationally applicable tool for assessing the quality of informed consent documents for elective procedures.
Design
Mixed qualitative-quantitative approach.
Setting
Convened seven meetings with stakeholders to obtain input and feedback on the tool.
Participants
Team of physician investigators, measure development experts, and a working group of nine patients and patient advocates (caregivers, advocates for vulnerable populations and patient safety experts) from different regions of the country.
Interventions
With stakeholder input, we identified elements of high-quality informed consent documents, aggregated into three domains: content, presentation and timing. Based on this comprehensive taxonomy of key elements, we convened the working group to offer input on the development of an abstraction tool to assess the quality of informed consent documents in three phases: (1) selecting the highest-priority elements to be operationalised as items in the tool; (2) iteratively refining and testing the tool using a sample of qualifying informed consent documents from eight hospitals; and (3) developing a scoring approach for the tool. Finally, we tested the reliability of the tool in a subsample of 250 informed consent documents from 25 additional hospitals.
Outcomes
Abstraction tool to evaluate the quality of informed consent documents.
Results
We identified 53 elements of informed consent quality; of these, 15 were selected as highest priority for inclusion in the abstraction tool and 8 were feasible to measure. After seven cycles of iterative development and testing of survey items, and development and refinement of a training manual, two trained raters achieved high item-level agreement, ranging from 92% to 100%.
Conclusions
We identified key quality elements of an informed consent document and operationalised the highest-priority elements to define a minimum standard for informed consent documents. This tool is a starting point that can enable hospitals and other providers to evaluate and improve the quality of informed consent.

Quality of informed consent documents among US. hospitals: a cross-sectional study
Original Research
Erica S Spatz, Haikun Bao, Jeph Herrin, Vrunda Desai, Sriram Ramanan, Lynette Lines, Rebecca Dendy, Susannah M Bernheim, Harlan M Krumholz, Zhenqiu Lin, Lisa G Suter
BMJ Open: Cardiovascular Medicine, 19 May 2020; 10(5)
Open Access
Abstract
Objective
To determine whether informed consent for surgical procedures performed in US hospitals meet a minimum standard of quality, we developed and tested a quality measure of informed consent documents.
Design
Retrospective observational study of informed consent documents.
Setting
25 US hospitals, diverse in size and geographical region.
Cohort
Among Medicare fee-for-service patients undergoing elective procedures in participating hospitals, we assessed the informed consent documents associated with these procedures. We aimed to review 100 qualifying procedures per hospital; the selected sample was representative of the procedure types performed at each hospital.
Primary outcome
The outcome was hospital quality of informed consent documents, assessed by two independent raters using an eight-item instrument previously developed for this measure and scored on a scale of 0–20, with 20 representing the highest quality. The outcome was reported as the mean hospital document score and the proportion of documents meeting a quality threshold of 10. Reliability of the hospital score was determined based on subsets of randomly selected documents; face validity was assessed using stakeholder feedback.
Results
Among 2480 informed consent documents from 25 hospitals, mean hospital scores ranged from 0.6 (95% CI 0.3 to 0.9) to 10.8 (95% CI 10.0 to 11.6). Most hospitals had at least one document score at least 10 out of 20 points, but only two hospitals had >50% of their documents score above a 10-point threshold. The Spearman correlation of the measures score was 0.92. Stakeholders reported that the measure was important, though some felt it did not go far enough to assess informed consent quality.
Conclusion
All hospitals performed poorly on a measure of informed consent document quality, though there was some variation across hospitals. Measuring the quality of hospital’s informed consent documents can serve as a first step in driving attention to gaps in quality.