Abstract:Introduction Patients in the intensive care unit (ICU) may be in an inadequate condition to give their informed consent for research. The aim of this study was to analyse the ability to recall participation in a clinical trial for which ICU patients had given their consent.
“…During the observations, we also found that patients ask questions about content that was already discussed by the vascular access team during the consent process. This may (1) reflect the shortcomings of the current process (ie, workload-related factors such as not spending enough time to discuss the procedure with the patient, or patient-related factors that affect comprehension such as pain and discomfort), (2) support the need for a self-paced resource such as multimedia PtDA available to patients when needed, or (3) suggest that the medical conditions of some patients in the ICUs and ACUs might be a barrier for patient engagement in the consent process [34], which advocates for the need to engage a proxy in the informed consent process [35].…”
BackgroundInformed consent has considerable clinical, ethical, and legal implications for patient safety and liability. Little information is available about the use of multimedia patient decision aids (PtDA) in the consent process for therapeutic invasive procedures such as the peripherally inserted central venous catheter (PICC). In addition, none of the available studies have designed their multimedia PtDAs based on the Agency for Healthcare Research and Quality’s (AHRQ) comprehensive guide for informed consent.ObjectiveThis paper describes a patient-centered, systematic, multidisciplinary approach to develop, implement, and alpha test a multimedia PtDA to reform the informed consent process of a PICC for patients in 10 acute and intensive care units.MethodsThe development, implementation, and evaluation processes of the PtDA followed the phases in the Multimedia Production Framework: preproduction, production, and postproduction. Within this framework, we applied the criteria for judging the quality of PtDAs, the AHRQ’s Health Literacy Universal Precautions Toolkit, and the AHRQ’s Patient Education Materials Assessment Tool Guide. The methodology was guided by the Interprofessional Shared Decision-Making Model and the AHRQ’s Making Informed Consent an Informed Choice guide. In the preproduction phase, we (1) reviewed the current consent form; (2) observed 18 consent processes; (3) surveyed the vascular access team (N=6 nurses) about their perception of the current process; (4) surveyed 30 patients for knowledge recall and retention, overall satisfaction, and attitude toward using a multimedia PtDA; and (5) wrote and reviewed the script for the multimedia program. The production phase focused on filming the PtDA in English and Spanish languages. The postproduction phase included integrating the multimedia programs into the care processes, developing a modified workflow for the consent process, and alpha testing of the English and Spanish PtDAs by (1) a group of 5 patients for clarity and understandability of the information; (2) nurses using the AHRQ’s Patient Education Materials Assessment Tool Audio and Video; and (3) by the multidisciplinary change team.ResultsBased on the alpha testing, patients indicated that the content was easy to follow and read; nurses provided positive feedback, and their comments were mainly related to the changes in the workflow in the consent process of the PICC after using the PtDA; and the multidisciplinary change team suggested edits related to changing a few scenes. The final multimedia program consisted of 7 min and 37 s demonstrating detailed information about the PICC.ConclusionsA systematic development of PtDAs for nonurgent invasive procedures may eliminate many limitations of the conventional consent process by ensuring comprehensive, standardized, and easy-to-comprehend information and providing sufficient time for the patients to reflect on the information. To be effective, PtDAs should follow a systematic, patient-centered, evidence-based, and rigorous approach in the ...
“…During the observations, we also found that patients ask questions about content that was already discussed by the vascular access team during the consent process. This may (1) reflect the shortcomings of the current process (ie, workload-related factors such as not spending enough time to discuss the procedure with the patient, or patient-related factors that affect comprehension such as pain and discomfort), (2) support the need for a self-paced resource such as multimedia PtDA available to patients when needed, or (3) suggest that the medical conditions of some patients in the ICUs and ACUs might be a barrier for patient engagement in the consent process [34], which advocates for the need to engage a proxy in the informed consent process [35].…”
BackgroundInformed consent has considerable clinical, ethical, and legal implications for patient safety and liability. Little information is available about the use of multimedia patient decision aids (PtDA) in the consent process for therapeutic invasive procedures such as the peripherally inserted central venous catheter (PICC). In addition, none of the available studies have designed their multimedia PtDAs based on the Agency for Healthcare Research and Quality’s (AHRQ) comprehensive guide for informed consent.ObjectiveThis paper describes a patient-centered, systematic, multidisciplinary approach to develop, implement, and alpha test a multimedia PtDA to reform the informed consent process of a PICC for patients in 10 acute and intensive care units.MethodsThe development, implementation, and evaluation processes of the PtDA followed the phases in the Multimedia Production Framework: preproduction, production, and postproduction. Within this framework, we applied the criteria for judging the quality of PtDAs, the AHRQ’s Health Literacy Universal Precautions Toolkit, and the AHRQ’s Patient Education Materials Assessment Tool Guide. The methodology was guided by the Interprofessional Shared Decision-Making Model and the AHRQ’s Making Informed Consent an Informed Choice guide. In the preproduction phase, we (1) reviewed the current consent form; (2) observed 18 consent processes; (3) surveyed the vascular access team (N=6 nurses) about their perception of the current process; (4) surveyed 30 patients for knowledge recall and retention, overall satisfaction, and attitude toward using a multimedia PtDA; and (5) wrote and reviewed the script for the multimedia program. The production phase focused on filming the PtDA in English and Spanish languages. The postproduction phase included integrating the multimedia programs into the care processes, developing a modified workflow for the consent process, and alpha testing of the English and Spanish PtDAs by (1) a group of 5 patients for clarity and understandability of the information; (2) nurses using the AHRQ’s Patient Education Materials Assessment Tool Audio and Video; and (3) by the multidisciplinary change team.ResultsBased on the alpha testing, patients indicated that the content was easy to follow and read; nurses provided positive feedback, and their comments were mainly related to the changes in the workflow in the consent process of the PICC after using the PtDA; and the multidisciplinary change team suggested edits related to changing a few scenes. The final multimedia program consisted of 7 min and 37 s demonstrating detailed information about the PICC.ConclusionsA systematic development of PtDAs for nonurgent invasive procedures may eliminate many limitations of the conventional consent process by ensuring comprehensive, standardized, and easy-to-comprehend information and providing sufficient time for the patients to reflect on the information. To be effective, PtDAs should follow a systematic, patient-centered, evidence-based, and rigorous approach in the ...
“…Very little is known about patient recall and understanding after oral versus written consent, whether that consent was granted for a research study or a clinical procedure; we therefore propose a nested study to compare these outcomes among the patients providing oral consent with those of patients providing written consent for participation in this study, as well as to outcomes of historical controls (patients providing written consent for participation in other trials, such as those followed by Chenaud et al . 35 We know that recall and understanding in the weeks after written consent are not optimal; our hypothesis is that they will not differ much (will not be significantly worse) after oral consent.…”
Section: Observational Substudiesmentioning
confidence: 94%
“…Another outcome will simply be the number of patients included in each arm, and the investigator’s cited reason for pursuing an oral versus written consent. Finally, we will perform correlation analyses for recall and understanding, looking at baseline demographic factors, other factors such as whether the patient asked a question during the initial information encounter, 35 whether family members were present and whether an attending physician or family member signed the witness testimony. Informed consent - recall and understanding post-consent Do you recall agreeing to participate in this study?…”
Section: Observational Substudiesmentioning
confidence: 99%
“…Given the hypothesis of non-inferiority in recall after oral versus written consent, a presumed recall after consent in the control (written) arm of roughly 80%, 35 and assuming a significance (alpha) level and power of 5% and 80%, respectively, roughly 198 patients would be needed in each arm to demonstrate non-inferiority with a margin of 10%, a sample size achievable given the context of the larger PIRATE trial. Nonetheless, we appreciate that we will ultimately be relying on a convenience sample.…”
IntroductionAntibiotic overuse drives antibiotic resistance. The optimal duration of antibiotic therapy for Gram-negative bacteraemia (GNB), a common community and hospital-associated infection, remains unknown and unstudied via randomised controlled trials (RCTs).Methods and analysisThis investigator-initiated, multicentre, non-inferiority, informatics-based point-of-care RCT will randomly assign adult hospitalised patients receiving microbiologically efficacious antibiotic(s) for GNB to (1) 14 days of antibiotic therapy, (2) 7 days of therapy or (3) an individualised duration determined by clinical response and 75% reduction in peak C reactive protein (CRP) values. The randomisation will occur in equal proportions (1:1:1) on day 5 (±1) of efficacious antibiotic therapy as determined by antibiogram; patients, their physicians and study investigators will be blind to treatment duration allocation until the day of antibiotic discontinuation. Immunosuppressed patients and those with GNB due to complicated infections (endocarditis, osteomyelitis, etc) and/or non-fermenting bacilli (Acinetobacter spp, Burkholderia spp, Pseudomonas spp) Brucella spp, Fusobacterium spp or polymicrobial growth with Gram-positive organisms will be ineligible. The primary outcome is incidence of clinical failure at day 30; secondary outcomes include clinical failure, all-cause mortality and incidence of Clostridiumdifficile infection in the 90-day study period. An interim safety analysis will be performed after the first 150 patients have been followed for ≤30 days. Given a chosen margin of 10%, the required sample size to determine non-inferiority is roughly 500 patients. Analyses will be performed on both intention-to-treat and per-protocol populations.Ethics and disseminationEthics approval was obtained from the cantonal ethics committees of all three participating sites. Results of the main trial and each of the secondary endpoints will be submitted for publication in a peer-reviewed journal.Trial registration numberThis trial is registered at www.clinicaltrials.gov (NCT03101072; pre-results).
“…So, researcher also looked for other measures. Sometimes, the specific informed consent was not obtained 53 . Some regulations also suggested waiver of consent in emergency cases as an exception.…”
Section: Ethics Of Consent In Critically Ill or Intensive Care Unit (mentioning
Background: Proper decision making capacity, adequate disclosure and voluntary decisions are basic constituents of informed consent which is required in surgical procedures, any interventions, any tissue collection, or any research involving the human participants. But, it becomes more hectic if the participants or patients are physically or mentally impaired for proper understanding or rational decision making. Time has gone by assembling or regulating effective laws for research involving persons with impaired decision making capacity. Still, question arises, is it ethical to enroll an incompetent person who is not physically or mentally fit to make a decision in risky research or interventional trials? If it is, how the informed consent and ethical measures can be taken? Method: Extensive literature review was done in Google scholar, PubMed and national or institutional websites with the corresponding keywords to summarize the cases of impaired decision making and regulation of informed consent and ethical measures in those cases. Results: Decision making capacity requires three level of capacities and four levels of abilities. If a person has factual understanding, implies a certain level of rational belief, knows to manipulate information to arrive at a choice and remains stable on the choice, is known to be capacitated in decision making. Impaired decision making capacity is more common in Alzheimers disease and schizophrenia research. Although a definite line between decisional capacity and incapacity is still in question, many assessment tools are available to conclude it. Moreover, decisional incapacity has been found as a significant ratio in general or psychiatric hospitals and nursing homes regarding psychological disorders or critically ill conditions. But, these conditions should not prevent anyone from understanding, choosing, or accepting any intervention as sometimes they may have some preserved abilities too. As per accepted ethics, respect for persons incorporates at least two ethical convictions. First, the individual should be treated as an autonomous agent and second, the person with diminished autonomy is entitled to protection. Thats why, in case of severe psychiatric diseases and Alzheimers diseases, surrogate consent is recommended. But surrogacy should be reviewed by the institutional review board (IRB). Multimedia consent process, advanced consent directives, rational consent waiver and many other processes are practiced in case of ethical research involving decisional incapacitate persons which are discussed in the paper. Conclusion: It should be clarified by the IRB whether involvement of impaired subjects has beneficial scientific aim or not. Capacity assessment system should be in an organized and systemic way. Threshold for capacity and recognition of persons able to conduct this process should be fixed. Role of surrogacy and involvement of IRB to align it in a proper manner is always a matter of concern. Consideration of risk management, subjects autonomy and assent-dissent issues should be clarified in research.
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