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.

The Effect of the Consent Process on Patient Satisfaction With Pain Management: A Randomized Controlled Trial
Pain management and sedation/original research
Safire Valentine, James Majer, Nicole Grant, Antony Ugoni, David M. Taylor
Annals of Emergency Medicine, 15 May 2020
Abstract
Study objective
We aim to determine whether the timing and context of informed consent affects the subjective outcome of patient satisfaction with pain management.
Methods
We conducted a randomized controlled trial in a single emergency department (ED). Patients aged 18 years or older with a triage pain score of greater than or equal to 4 provided consent to participate in a pain management study. They were randomized to consent in the ED or at follow-up. All patients were followed up at 48 hours post–ED discharge. Patients who consented at follow-up were unaware of the study until cold called. The primary outcome was patient satisfaction with pain management. Secondary analyses examined effects on follow-up and participation rates. Variables associated with patients’ being very satisfied were determined with multivariate logistic regression.
Results
Outcome data were obtained on 655 of 825 patients enrolled (79.4%). Patients who provided consent at follow-up were less likely to be very satisfied compared with those who consented in the ED (difference in proportions 11.5%; 95% confidence interval 3.5 to 19.4). Follow-up and participation rates did not differ between the groups. Patients who received pain advice and adequate analgesia (both as defined in this study) were more likely to be very satisfied (odds ratio 5.18, 95% confidence interval 2.82 to 9.52; and odds ratio 1.54, 95% confidence interval 1.07 to 2.22, respectively).
Conclusion
The timing and context of informed consent significantly affect the subjective outcome of patient satisfaction, and this should be considered during study design. Clinicians should strive to provide pain advice and adequate analgesia to maximize their patients’ satisfaction.

Capacity to consent to medical procedures [BOOK CHAPTER]
Deborah Slater
Assessing Mental Capacity: A Handbook to Guide Professionals from Basic to Advanced Practice
Routledge, 4 May 2020; Chapter 13
Abstract Only Available
The law requires professionals to ensure that a person is able to give consent before any form of treatment, investigation or care is given. Consent must be valid and it should be given freely and voluntarily (Royal College of Nursing, 2017). This section will explore what you need to know and the process you need to follow to carry out an assessment of capacity to consent to treatment.

Bundled Consent in US Intensive Care Units
Maria L. Espinosa, Aaron M. Tannenbaum, Megha Kilaru, Jennifer Stevens, Mark Siegler, Michael D. Howell, William F. Parker
American Journal of Critical Care, 1 May 2020; 29(3) e44–e51
Open Access
Abstract
Background
Bundled consent, the practice of obtaining anticipatory consent for a predefined set of intensive care unit procedures, increases the rate of informed consent conversations and incorporation of patients’ wishes into medical decision-making without sacrificing patients’ or surrogates’ understanding. However, the adoption rate for this practice in academic and nonacademic centers in the United States is unknown.
Objective
To determine the national prevalence of use of bundled consent in adult intensive care units and opinions related to bundled consent.
Methods
A random sample of US hospitals with medical/surgical intensive care units was selected from the AHA [American Hospital Association] Guide. One intensive care unit provider (bedside nurse, nurse manager, or physician) from each hospital was asked to self-report use of per-procedure consent versus bundled consent, consent rate for intensive care unit procedures, and opinions about bundled consent.
Results
Of the 238 hospitals contacted, respondents from 100 (42%) completed the survey; 94% of respondents were nurses. The prevalence of bundled consent use was 15% (95% CI, 9%–24%). Respondents using per-procedure consent were more likely than those using bundled consent to self-report performing invasive procedures without consent. Users of bundled consent unanimously recommended the practice, and 49% of respondents using per-procedure consent reported interest in implementing bundled consent.

Preoperative Patient Education Class during an Orthopaedic Mission Trip: Effects on Knowledge, Anxiety, and Informed Consent
Mitchell A. Solano, Kaaleswar K. Ramcharran, Lynne C. Jones, Robert S. Sterling, David R. Samaroo, Harpal S. Khanuja
The Journal of Arthroplasty, 1 May 2020
Abstract
Background
Patient knowledge about arthritis and risks, benefits, and outcomes of joint replacement in developing countries is unknown. We evaluated the effectiveness of a preoperative class on improving knowledge and decreasing anxiety during a surgical mission trip offering total joint replacement surgery.
Methods
A team of U.S. healthcare providers taught a preoperative class to 41 patients selected for total joint replacement during a surgical mission trip to Guyana. Participants completed a 32-point survey about arthritis; indications, risks, and benefits of joint replacement; and postoperative, in-patient rehabilitation expectations. The State-Trait Anxiety Inventory was used to measure participant anxiety. Participants completed identical surveys before and after class. Matched-pairs Student’s t-tests were used to compare means between pre- and post-class surveys. Significance was accepted at P < .05.
Results
Seventy-eight percent of patients (31/41) scored less than 12 of 32 possible points (40%) on the pre-class knowledge questionnaire. Mean ± standard deviation knowledge scores improved from 14.0 ± 4.5 before the class to 16.5 ± 6.5 after the class (P = .008). Anxiety scores (n = 33) improved from 35 ± 13 before the class to 33 ± 12 after the class (P = .047).
Conclusion
On this surgical mission trip, underserved patients’ knowledge about total joint replacement increased only modestly after taking a preoperative class. Greater understanding of how to educate patients and reduce their anxiety on medical missions is needed.