Evidence-Based Nudging: Best Practices in Informed Consent

2015 ◽  
Vol 15 (10) ◽  
pp. 43-45 ◽  
Author(s):  
Ricky Munoz ◽  
Mark Fox ◽  
Michael Gomez ◽  
Scott Gelfand
2018 ◽  
Author(s):  
Srijesa Khasnabish ◽  
Zoe Burns ◽  
Madeline Couch ◽  
Mary Mullin ◽  
Randall Newmark ◽  
...  

BACKGROUND Data visualization experts have identified core principles to follow when creating visual displays of data that facilitate comprehension. Such principles can be applied to creating effective reports for clinicians that display compliance with quality improvement protocols. A basic tenet of implementation science is continuous monitoring and feedback. Applying best practices for data visualization to reports for clinicians can catalyze implementation and sustainment of new protocols. OBJECTIVE To apply best practices for data visualization to create reports that clinicians find clear and useful. METHODS First, we conducted a systematic literature review to identify best practices for data visualization. We applied these findings and feedback collected via a questionnaire to improve the Fall TIPS Monthly Report (FTMR), which shows compliance with an evidence-based fall prevention program, Fall TIPS (Tailoring Interventions for Patient Safety). This questionnaire was based on the requirements for effective data display suggested by expert Stephen Few. We then evaluated usability of the FTMR using a 15-item Health Information Technology Usability Evaluation Scale (Health-ITUES). Items were rated on a 5-point Likert scale from strongly disagree (1) to strongly agree (5). RESULTS The results of the systematic literature review emphasized that the ideal data display maximizes the information communicated while minimizing the cognitive efforts involved with data interpretation. Factors to consider include selecting the correct type of display (e.g. line vs bar graph) and creating simplistic reports. The qualitative and quantitative evaluations of the original and final FTMR revealed improved perceptions of the visual display of the reports and their usability. Themes that emerged from the staff interviews emphasized the value of simplified reports, meaningful data, and usefulness to clinicians. The mean (SD) rating on the Health-ITUES scale when evaluating the original FTMR was 3.86 (0.19) and increased to 4.29 (0.11) when evaluating the revised FTMR (Mann Whitney U Test, z=-12.25, P<0.001). CONCLUSIONS Best practices identified through a systematic review can be applied to create effective reports for clinician use. The lessons learned from evaluating FTMR perceptions and measuring usability can be applied to creating effective reports for clinician use in the context of other implementation science projects.


2021 ◽  
Vol 7 (1) ◽  
Author(s):  
Alina Weise ◽  
Julia Lühnen ◽  
Stefanie Bühn ◽  
Felicia Steffen ◽  
Sandro Zacher ◽  
...  

Abstract Background Practitioners frequently use informed consent forms to support the physician-patient communication and the informed consent process. Informed consent for surgery often focuses on risk centered information due to high liability risks for treatment errors. This may affect patients’ anxiety of adverse events and the nocebo effect. This study focuses on the optimization of pre-surgical information on risks and complications, and at the same time reconciles these information with legal requirements. Methods The development, piloting, and evaluation of evidence-based informed consent forms for total knee arthroplasty (TKA) and related anesthesia procedures will follow the UK MRC Framework for developing and evaluating complex interventions. Conducting different sub-studies, we will (I) qualitatively explore the information acquisition and decision-making processes, (II) develop and pilot test evidence-based informed consent forms on the example of TKA and related anesthesia procedures, (III) conduct a monocentric interrupted time series (ITS) pilot study to evaluate the effects of evidence-based informed consent forms in comparison with standard consent forms, and (IV) perform a process evaluation to identify barriers and facilitators to the implementation of the intervention and to analyze mechanisms of impact. Discussion The evidence-based and understandable presentation of risks in informed consent forms aims at avoiding distorted risk depiction and strengthening the patients’ competencies to correctly assess the risks of undergoing surgery. This might reduce negative expectations and anxiety of adverse events, which in turn might reduce the nocebo effect. At the same time, the practitioners’ acceptance of evidence-based informed consent forms meeting legal requirements could be increased. Trial registration ClinicalTrials.gov, NCT04669483. Registered 15 December 2020. German Clinical Trials Registry, DRKS00022571. Registered 15 December 2020


Author(s):  
Elizabeth A. Johnson ◽  
Jane M. Carrington

It is estimated 1 in 3 clinical trials utilize a wearable device to gather real-time participant data, including sleep habits, telemetry, and physical activity. While wearable technologies (including smart watches, USBs, and implantable devices) have been revolutionary in their ability to provide a higher precision and accuracy to data acquisition external to the research milieu, there is hesitancy among providers and participants alike given security concerns, perception of cyber-related threats, and meaning attributed to privacy issues. The purpose of this research is to define cyber-situational awareness (CSA) as it pertains to clinical trials, evaluate its current measurement, and describe best practices for research investigators and trial participants to enhance protections in the digital age. This paper reviews integrated elements of CSA within the process of informed consent when wearable devices are implemented for trial procedures. Evaluation of CSA as part of informed consent allows the research site to support the participant in knowledge gaps surrounding the technology while also providing feedback to the trial sponsor as to technology improvements to enhance usability and wearability of the device.


Author(s):  
Sarah A. Powers ◽  
Kimberly N. Perry ◽  
Amanda J. Ashdown ◽  
Matthew Pacailler ◽  
Mark W. Scerbo

During the COVID-19 pandemic, changes to telehealth laws and policies enabled more patients to meet with their healthcare providers remotely. The rapid implementation of telehealth has resulted in providers and patients interacting remotely with few existing standards or guidelines. Additionally, a cursory search of telehealth guidelines for patients revealed overly broad recommendations related to technology, security, and environmental requirements. Although researchers have recommended some human factors considerations for guidelines, these recommendations were rarely implemented in the guidelines we reviewed. Therefore, human factors professionals can contribute further by implementing best practices for telehealth appointments to create evidence-based standardized guidelines. Some initial areas to focus on include accessibility for patients, overcoming typical telehealth barriers, and addressing a wider diversity of patients.


2018 ◽  
Vol 34 (1) ◽  
pp. 29-31 ◽  
Author(s):  
Gabrielle Rocque ◽  
Ellen Miller-Sonnet ◽  
Alan Balch ◽  
Carrie Stricker ◽  
Josh Seidman ◽  
...  

Although recognized as best practice, regular integration of shared decision-making (SDM) approaches between patients and oncologists remains an elusive goal. It is clear that usable, feasible, and practical tools are needed to drive increased SDM in oncology. To address this goal, we convened a multidisciplinary collaborative inclusive of experts across the health-care delivery ecosystem to identify key principles in designing and testing processes to promote SDM in routine oncology practice. In this commentary, we describe 3 best practices for addressing challenges associated with implementing SDM that emerged from a multidisciplinary collaborative: (1) engagement of diverse stakeholders who have interest in SDM, (2) development and validation of an evidence-based SDM tool grounded within an established conceptual framework, and (3) development of the necessary roadmap and consideration of the infrastructure needed for engendering patient engagement in decision-making. We believe these 3 principles are critical to the success of creating SDM tools to be utilized both within and outside of clinical practice. We are optimistic that shared use across settings will support adoption of this tool and overcome barriers to implementing SDM within busy clinical workflows. Ultimately, we hope that this work will offer new perspectives on what is important to patients and provide an important impetus for leveraging patient preferences and values in decision-making.


2019 ◽  
Vol 6 (4) ◽  
pp. 285-291
Author(s):  
Ying Liu ◽  
Ya-Jing Fan ◽  
Wei Zhuang ◽  
Qun Huang

Abstract Objective Postpartum hemorrhage (PPH) is a leading cause of maternal death. Although guidelines have been updated, those with detailed protocols are limited for nursing practice. This study aims at establishing an early assessment and intervention protocol as a toolkit for PPH for midwives and obstetrical nurses. Methods Employing the evidence-based method, a systematic Internet search of guidelines was conducted and appraisal of literatures was conducted with AGREE system and Oxman-Guyatt Overview Quality Assessment Questionnaire (OQAQ), according to which a protocol draft was therefore developed. Then, a two-round modified Delphi method was utilized to reach a consensus of the protocol built on best practices. Selection criteria for each intervention measure included consensus level with a threshold of 70%, mean of importance (M) >3.5, and coefficient of variation (CV) <0.25. Reliability of experts’ opinion was calculated by positive coefficient and authoritative coefficient. Items without consistency were enlisted in the second-round consult. When all items met the selection criteria, the protocol would be finally formulated. Results A 122-measure protocol was established, including prevention, assessment, and intervention of PPH. With a panel of 14 experts participated in the consult, the positivity coefficient was 0.93 and 1.00 for two rounds, respectively, and the authority coefficient was 0.88. After a two-round consult and revision of the draft, the final program was formulated, containing 5 first-level indexes and 14 second-level indexes with a total item of 120. Conclusions The PPH protocol, based on high-quality evidences, was formulated with a two-round Delphi method, which can provide insight for midwives and obstetrical nurses to effectively deal with PPH.


2021 ◽  
Author(s):  
Marc Schlossberg ◽  
◽  
Rebecca Lewis ◽  
Aliza Whalen ◽  
Clare Haley ◽  
...  

This report summarizes the primary output of this project, a book of COVID-era street reconfiguration case studies called Rethinking Streets During COVID-19: An Evidence-Based Guide to 25 Quick Redesigns for Physical Distancing, Public Use, and Spatial Equity. COVID-era needs have accelerated the process that many communities use to make street transformations due to: a need to remain physically distanced from others outside our immediate household; a need for more outdoor space close to home in every part of every community to access and enjoy; a need for more space to provide efficient mobility for essential workers in particular; and a need for more space for local businesses as they try to remain open safely. This project is the third in a series of NITC-supported case study books on best practices in street reconfigurations for more active, sustainable, and in this case, COVID-supportive uses. The full, 154-page book is available for free download from the National Institute for Transportation and Communities (NITC).


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