eMethods. Information on Participant Eligibility, Recruitment, and Data Collection
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Corneli A, Perry B, Collyar D, et al. Assessment of the Perceived Acceptability of an Early Enrollment Strategy Using Advance Consent in Health Care–Associated Pneumonia. JAMA Netw Open. 2018;1(8):e185816. doi:10.1001/jamanetworkopen.2018.5816
Is an early enrollment strategy using advance consent for research on health care–associated pneumonia acceptable to stakeholders?
In this qualitative study of 52 stakeholders (patients at risk for pneumonia, caregivers, study investigators and coordinators, and representatives of institutional review boards), patients and caregivers found approaching patients and monitoring their records before they acquire pneumonia to be acceptable, indicated that patients can understand consent information before diagnosis, and described preferences for opt-out and precedent autonomy procedures. Institutional review board representatives were supportive of the strategy, and investigators and study coordinators indicated it would not be burdensome.
Results of the study suggest that an early enrollment strategy is acceptable to stakeholders and should be evaluated for effectiveness in increasing enrollment in registrational clinical trials.
Better treatment options are needed in life-threatening infections, including health care–associated pneumonia. Enrolling patients in antibacterial clinical trials before diagnosis may circumvent existing time-to-enrollment constraints. However, the acceptability of an early enrollment strategy using advance consent is unknown.
To assess the perceived acceptability of an early enrollment strategy for enrolling patients in an antibacterial clinical trial before a pneumonia diagnosis.
Design, Setting, and Participants
This qualitative, descriptive study used semistructured telephone interviews. Framed within a planned noninferiority pneumonia antibiotic trial, an early enrollment strategy was described and perceptions were assessed. Using this strategy, patients give consent to enroll before developing pneumonia, to be monitored by study staff, and to be randomly assigned a study antibiotic if pneumonia develops. All interviews were audiorecorded, transcribed verbatim, and analyzed using applied thematic analysis. Fifty-two key stakeholders from across the United States, including 18 patients at risk of pneumonia, 12 caregivers, 10 representatives of institutional review boards, 7 investigators, and 5 study coordinators, were interviewed from June 20 to August 19, 2016.
Main Outcomes and Measures
Perceived acceptability of the early enrollment strategy.
Among the 52 stakeholders interviewed (ages 29-75 years; 14 women), patients and caregivers expressed no concerns about patients being approached about participation before developing pneumonia; however, some patients may experience anxiety on learning about their risk for pneumonia. No concerns with study staff accessing patients’ medical records were expressed. The clarity of consent information was important for understanding the study rather than having the condition under investigation. Among patients, caregivers, and institutional review board representatives, preferences varied regarding opt-out and precedent autonomy procedures. Nearly all patients would be willing to join a trial using the early enrollment strategy and caregivers would be willing to provide proxy consent. Institutional review board representatives were supportive of the strategy and made recommendations for the study protocol, primarily around informed consent. Investigators and study coordinators believed the strategy would not be burdensome and offered suggestions to ensure its feasibility.
Conclusion and Relevance
Results of the study suggest that the early enrollment strategy is acceptable. Future research should evaluate whether the strategy improves enrollment rates in registrational pneumonia trials and in trials of other acute infection syndromes with narrow enrollment windows and/or patients with transient decisional incapacity.
On any given day, approximately 1 in 25 patients in US acute care hospitals have a health care–associated infection. Two of the most common infections are hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP).1 Pneumonia caused by susceptible and resistant pathogens is associated with the most infection-related deaths in the United States and is the eighth leading cause of death overall.2 However, high-quality clinical trials to identify antibiotics for HABP/VABP are difficult to conduct and prohibitively expensive, costing upwards of $90 000 per enrolled patient, primarily because of the large number of patients who must be screened for eligibility.3 This apparent paradox between common infections and infrequent trial eligibility is in part attributable to difficulty in identifying patients, confirming HABP/VABP, and obtaining informed consent from patients who urgently need treatment and from very ill patients who may no longer be able to consent for themselves.4,5 Moreover, prior effective antibacterial drug therapy may limit the ability to assess the effect of a new antibacterial drug in a noninferiority clinical trial.6-8 These factors lead to a very limited window for enrollment.
As part of its project portfolio on antibacterial drug development,9 the Clinical Trials Transformation Initiative, a public-private partnership cofounded by the US Food and Drug Administration (FDA) and Duke University, Durham, North Carolina, held multistakeholder meetings to address challenges in conducting HABP/VABP clinical trials and to explore alternative enrollment models.8,10 A novel early enrollment strategy emerged from these discussions, whereby patients at high risk for HABP/VABP while in the hospital are asked to provide advance consent to participate in clinical research—that is, they are enrolled in a clinical research study on HABP/VABP before being diagnosed with either type of pneumonia. Patients consent to monitoring by study staff and, if HABP/VABP develops, to being randomly assigned to receive an investigational or a comparator antibiotic. Advance consent is typically used in situations when individuals (1) may lose their decision-making capacity11 or (2) are at high risk for a condition for which therapy must be initiated without delay.12 Clinical trials for HABP/VABP fall within the latter condition, in which research is limited; almost all research on advance consent focuses on persons with dementia or on broad advance research directives.11,13-19
The Clinical Trials Transformation Initiative planned to conduct a pilot study to evaluate the effectiveness of early enrollment using advance consent in a noninferiority antibiotic treatment trial. However, because questions about acceptability remained, we conducted formative research to assess the acceptability of the early enrollment strategy among key stakeholders.
We conducted a qualitative, descriptive study using semistructured telephone interviews with the following 5 key stakeholder groups involved in HABP/VABP clinical research: patients, caregivers, representatives of institutional review boards (IRBs), investigators, and study coordinators. Interviews were conducted from June 20 to August 19, 2016. The IRB of the Duke University Health System determined that the research met the requirements for exemption from further IRB review. Written informed consent was not required. Instead, all participants received an information sheet before study participation that explained the study in detail, including its purpose, risks, and benefits.
We used purposeful sampling20 to select participants who were at risk of HABP/VABP (ie, patients), had a family member at risk of HABP/VABP (ie, caregivers), or had experience with research on HABP/VABP (ie, IRB representatives, investigators, and study coordinators). The eMethods in the Supplement provides more information about eligibility and recruitment.
We began each interview by describing the early enrollment strategy. We then described the antibiotics to be used in the treatment phase of the research. After describing all study-related information and answering participants’ questions, we asked questions about the acceptability of the early enrollment strategy. Constructs of acceptability were informed by an established feasibility framework21 and varied by participant group (Table 1). We used a vignette-based approach22 to explore participants’ perceptions of opt-out and precedent autonomy23 procedures. All interviews were audiorecorded with the participants’ permission. The eMethods in the Supplement provides more information about data collection.
We use descriptive statistics to summarize characteristics of the study participants, and we used applied thematic analysis24 to analyze participants’ narratives. All interviews were transcribed verbatim following a standardized transcription protocol.25 We used NVivo qualitative data analysis software (version 11; QSR International Pty Ltd) to apply structural codes to segment participants’ narratives into conceptual categories based on the topics explored in the interviews. We assessed intercoder reliability on at least 1 interview from each participant group; we discussed discrepancies, revised the codebook, and recoded transcripts when necessary. Next, we inductively identified and applied content-derived codes to the narratives in each structural coding report, allowing for identification of issues salient to participants. We then organized content codes thematically, depending on relationships between codes. Summary reports described the major themes and subthemes and provided illustrative quotations.
We interviewed 52 key stakeholders from across the United States, including 18 patients at risk of HABP/VABP, 12 caregivers of patients at risk of HABP/VABP, 10 IRB representatives, 7 investigators, and 5 study coordinators. Among patients, a range of ages were represented (29-75 years), 14 were women, all 18 self-identified as white, and 10 had a bachelor’s degree or higher. Among caregivers, 9 ranged in age from 45 to 64 years, 8 were women, 10 were white, and all 12 had at least a high school education (Table 2).
Investigators were all from different institutions, as were the study coordinators and IRB representatives (except for 2 IRB members—1 community member and 1 scientific member—who were from the same university). All investigators were participating as site investigators in the associated Predicting Pneumonia in Hospitalized Patients in the ICU (PROPHETIC) study—a prospective observational cohort study conducted at 28 intensive care units (ICUs) in the United States to determine the proportion of at-risk patients who develop pneumonia26—and had experience in conducting phases 1 through 3 clinical trials. Three study coordinators were also involved in the PROPHETIC study, and 2 served as coordinators in other ICU-based studies. Among the IRB representatives, 6 were IRB chairpersons, 2 were scientific members, and 2 were community members; 8 had 5 or more years of experience as IRB representatives.
Patients and caregivers expressed no concerns about being approached in the ICU about a clinical trial on treatment for pneumonia before the patient was diagnosed with the condition. Several explained that they were not concerned because (1) they already knew their own or the patient’s risk for pneumonia in general or when people are hospitalized; or (2) they understood that, given their own or the patient’s underlying health conditions, being asked to consider a trial on pneumonia specifically, in comparison with other unrelated conditions, would not seem unrealistic (concept 1, Table 3).
Approximately one-third of patients believed they or other patients would experience anxiety after learning about their risk of pneumonia. However, just as many patients said learning about their risk would not be surprising given their current health condition, and even more said they would appreciate being informed about the risk. Several patients added that it would be important to inform patients about the health care team’s plan to reduce the patient’s risk (concept 2, Table 3).
Although some acknowledged concern, caregivers expressed less anxiety about learning of a patient’s risk of pneumonia than the patients did. Caregivers’ narratives primarily focused on their current awareness or understanding of the risk and the importance of being informed of and having a plan to reduce the risk (concept 3, Table 3).
Nearly all patients and caregivers said that not having pneumonia at the time of advance consent would not influence their or another patient’s ability to understand consent information. Patients’ narratives primarily focused on appropriate disclosure of information about the trial as the key to patients’ understanding, rather than the embodiment of the specific condition under investigation. However, several patients emphasized the importance of the risk context. For those who are aware of their pneumonia risk, understanding the study would not be difficult; for those who are unaware, they must first be informed of their risk to facilitate understanding.
Some patients and caregivers indicated that the patient’s broader health context—that is, their current medical condition and generally being very ill—could pose barriers to understanding or the patient’s or caregiver’s ability to focus on the consent information. They explained that the priority of patients in the ICU will be on their current critical illness, and not on other conditions they may acquire during hospitalization. In addition, a few patients believed that some patients may need more time to consider their participation if just learning about their pneumonia risk (concept 4, Table 3).
Participants’ responses are situated within the context of designing a specific opt-out procedure when advance consent is used. Participants’ views varied on whether study staff should actively confirm trial participation wishes from patients who develop pneumonia before giving the study antibiotic or proceed with randomization on diagnosis and provide the study antibiotic without patient confirmation, with the caveat that participants can opt out of research at any time. Almost twice as many patients said “a conversation” with the patient should happen to confirm that study participation is still preferred, compared with patients who said study staff should proceed with randomization without confirmation. Similarly, more IRB representatives said patients’ previous consent should be confirmed at the time of randomization than said that no confirmation was necessary. With this confirmation approach, participants said that study staff should inform the patient that they have developed pneumonia, remind them of their advance consent, explain again the next steps, and confirm their agreement to proceed with randomization. However, some of these IRB representatives said they chose this approach only because investigators were designing an opt-out component to include in the study design; otherwise, they believed study staff should proceed with randomization because of the patient’s right to withdraw from research at any time (concept 1, Table 4).
For those who believed that confirming participation on diagnosis was unnecessary, most said study staff should inform patients that they have developed pneumonia and proceed with randomization, per the advance consent that patients provided. One IRB representative, a chairperson, expressed that confirming the agreement defeats the purpose of using an early enrollment strategy. Caregivers were almost equally divided between the 2 approaches (concept 2, Table 4).
Perspectives also varied on precedent autonomy, that is, how to proceed when patients initially give advance consent but are unconscious at the time of randomization. About the same numbers of patients and caregivers said randomization should proceed based on the patient’s initial consent, compared with those who said a legally authorized representative (LAR) should have the option to withdraw the patient. Nearly all patients and caregivers who supported the patient’s initial consent suggested that LARs should be informed at the time of randomization that patients will be treated with a study antibiotic, and many said LARs should not be allowed to change the patient’s initial consent. Several patients acknowledged possible conflicts in situations where LARs do not want randomization to continue and suggested LARs be informed of the patient’s wishes at the time of advance consent to avoid future complications. Among patients and caregivers who said LARs should have the option to opt out patients, most stressed framing the discussion around the patient’s initial wishes. None of the patients or caregivers said standard treatment should be given. A few patients and caregivers suggested the consent form should explain procedures that will be followed if the patient becomes incapacitated or should indicate patients’ opt-out preferences if they subsequently become unconscious.
Among IRB representatives, just more than half said patients who become incapacitated before randomization should continue to randomization if pneumonia develops, based on their initial consent. They stressed that these patients previously gave informed consent for randomization if they were to develop pneumonia, making confirmation from LARs unnecessary. In addition, several said LAR confirmation “makes logistics more complicated.” A few IRB members said LARs should have the option to opt out the patients, although some acknowledged that they made their choice because the trial design included a specific opt-out component and, therefore, the study must provide a specific process for opting out. Several also discussed that the consent form should document patients’ wishes should they become unconscious or state the study procedures for when patients become unconscious (concept 3, Table 4).
None of the IRB representatives expressed concern with the early enrollment strategy from an ethical and regulatory perspective. Half stated the strategy was “pretty straightforward” and “very reasonable” (section 1, Box). Without prompting, nearly half also offered advantages to using the early enrollment strategy, such as providing patients with more time to consider participation and obtaining patients’ consent before they become too sick (section 2, Box).
“Well, this sounds like a simple study. I’m not seeing any real issues it raises.”—IRB chairperson 1
“It is reasonable for somebody to consent to something ahead of time, before they might have [pneumonia].”—IRB chairperson 5
“Honestly, this sounds fairly straightforward. It doesn’t sound like it’s going to cause a great deal of concern.”—IRB community member 2
“I actually think it’s somewhat kinder to ask somebody to enroll in this kind of trial before they get the infection so they have time to consider it…rather than at the time they’re acutely ill and may be needing ventilation…I really like it for that reason.”—IRB chairperson 3
“It almost seems easier to fathom that people would have the opportunity to really think through the consent and decide if they want to participate or not [compared with] the patient who’s already acutely ill, where they’re trying to make a decision at that moment, and then they may feel more pressure, as opposed to the situation where there is less time pressure to make the decision about whether to be in the study or not.”—IRB chairperson 4
“The advantage is you give individuals, presumably, a longer run-up time to actually think about whether they would want to be enrolled in it, and there is also a higher likelihood that the actual subject would be able to consent as opposed to a legally authorized representative…one would think they would be more likely well enough to be able to consent for themselves. So I think it has—it has a number of advantages from that standpoint. —IRB chairperson 2
Several IRB representatives said investigators must ensure that patients (1) are capable of providing informed consent when in the ICU, (2) fully understand they can withdraw at any time, and (3) are provided with an “appropriate and adequate” consent form, particularly because patients are informed that they are at risk of a life-threatening condition (which could cause anxiety) and asked to provide their consent for a condition they have not experienced. Several IRB representatives added that a process for engaging patients’ LARs should be developed, especially in situations when patients lose consciousness between giving advance consent and randomization.
Nearly all investigators and study coordinators believed the early enrollment strategy would not be burdensome to implement, although several acknowledged that there would be a large number of patients to be consented and monitored who might not develop HABP/VABP, making it “an inefficiency, but not a burden.” Some highlighted critical factors necessary for the early enrollment strategy to be feasible, primarily using appropriate eligibility criteria, collecting limited data before randomization, and budgeting realistically for staff time.
When envisioning themselves in the ICU, nearly all patients and caregivers said they would be willing or likely willing to enroll or to give their proxy consent, respectively, in an early enrollment noninferiority clinical trial that evaluated 2 commonly used antibiotics for treating HABP/VABP (an FDA-approved antibiotic for pneumonia and an FDA-approved antibiotic for other serious infections but not pneumonia). Of those who said they would not provide their consent, their reasons were related to the treatment phase of the trial and not to the early enrollment strategy or advance consent.
None of the patients and caregivers expressed concern about monitoring of patients’ hospital records by study staff (although staff typically does not have such access) to determine whether patients develop pneumonia while in the ICU. Several patients and caregivers explained that their lack of concern was because they perceived it as commonplace for multiple health-care personnel to access patient records, that study staff are professionals, that the monitoring of patient records was in the patient’s best interest, that reviewing patient records was necessary to conduct the study, and that the information learned would be kept confidential and used for study purposes only.
Our findings suggest that an early enrollment strategy with advance consent is acceptable among key stakeholders. Patients and caregivers reported that approaching patients for research participation before a diagnosis of HABP/VABP was appropriate, given the context, but informing them of their risk for the condition may be concerning to some. Information disclosure was described by patients and caregivers as critical to understanding consent information, rather than the fact of having the condition under investigation. Patients and caregivers believed they would be willing to allow study staff to review the patient’s medical records before diagnosis and to give their consent to participate in the proposed noninferiority trial that used an early enrollment strategy.
The IRB representatives expressed no ethical or regulatory concerns with the early enrollment strategy using advance consent and provided advice on study procedures to incorporate when the strategy is used. Investigators and study staff acknowledged the additional workload of obtaining consent from potential participants, but they believed an early enrollment strategy would be feasible to implement. One critical consideration in moving forward with an early enrollment strategy is the ratio of patients screened to those enrolled, that is, how many patients would need to be approached for early consent to yield 1 patient enrolled in an interventional study. The PROPHETIC study mentioned previously is part of an effort to define rates of incident pneumonia among specific subpopulations, which will enable a targeted approach.26
Variation in participants’ perceptions were observed regarding opt-out and precedent autonomy procedures. For future studies using the early enrollment strategy, findings from additional research with the study population or guidance from community advisory structures may indicate the best opt-out approaches to use. With precedent autonomy, documenting the patient’s wishes at the time of consent and sharing this information with the patient’s LAR may be appropriate if the patient is willing to disclose their study participation.
Our findings should be considered within the context in which the data were gathered. Because we interviewed investigators, study coordinators, and representatives from IRBs who were engaged in the PROPHETIC study, they may have been more accepting of the proposed early enrollment strategy to HABP/VABP clinical trials than those without this experience. However, their responses were grounded in actual HABP/VABP research experiences, which we believe better inform perceptions of the acceptability of the early enrollment strategy compared with hypothetical responses from individuals without this experience. In addition, as is typical with formative research, we purposely selected patients who were similar to patients enrolled in HABP/VABP interventional studies and likely similar to those who will participate in the future research. Although we anticipate similar risk factors between the formative and future study populations, the demographic characteristics could differ. As with all formative research, a limitation is that participants describe their perceptions of how they believe they would respond to certain situations; once they actually experience the situation, their viewpoints may change. Nonetheless, formative research provides useful information in making decisions about moving forward with clinical research by ensuring that aspects are included that stakeholders believe will be important. In our case, we learned that the early enrollment strategy with advance consent is an acceptable approach.
Although our use of the early enrollment strategy focuses on HABP/VABP, this approach also may be applicable to trials in other conditions for which time is of the essence and/or recurrent episodes of decisional incapacity occur. For example, patients who are at risk of HABP/VABP are also at risk of other ICU-acquired infections, such as bloodstream infections, complicated urinary tract infections, and Clostridium difficile colitis. Similarly, trials with patients with noninfectious chronic conditions with frequent exacerbations—eg, sickle cell disease or asthma—could also use this strategy. Trials on conditions with recurrent, temporary decisional incapacity, such as patients with cirrhosis who are prone to recurrent bouts of hepatic encephalopathy, could also use an early enrollment strategy at a time when the patient is able to meaningfully participate in consent discussions.
The early enrollment strategy with advance consent appears to be an acceptable approach among key stakeholders. Given its potential to improve trial feasibility and to generate urgently needed data to improve patient care, our findings suggest that sponsors should evaluate whether the early enrollment strategy improves enrollment rates in registrational HABP/VABP clinical trials. Qualitative research should be embedded into such trials to explore patients’ and caregivers’ reactions to the strategy in real-world settings.
Accepted for Publication: October 24, 2018.
Published: December 14, 2018. doi:10.1001/jamanetworkopen.2018.5816
Open Access: This is an open access article distributed under the terms of the CC-BY License. © 2018 Corneli A et al. JAMA Network Open.
Corresponding Author: Amy Corneli, PhD, Department of Population Health Sciences, Duke University School of Medicine, 215 Morris St, Durham, NC 27701 (email@example.com).
Author Contributions: Dr Corneli had full access to all the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.
Concept and design: Corneli, Perry, Collyar, Powers, Farley, Calvert, Santiago, Donnelly, Fowler, Holland.
Acquisition, analysis, or interpretation of data: Corneli, Perry, Collyar, Calvert, Swezey, Dombeck, De Anda, Holland.
Drafting of the manuscript: Corneli, Perry, Powers, Santiago, Fowler, Holland.
Critical revision of the manuscript for important intellectual content: Corneli, Perry, Collyar, Powers, Farley, Calvert, Santiago, Donnelly, Swezey, Dombeck, De Anda, Holland.
Statistical analysis: Corneli, Swezey.
Obtained funding: Fowler.
Administrative, technical, or material support: Corneli, Perry, Collyar, Calvert, Santiago, Donnelly, Dombeck, De Anda.
Supervision: Corneli, Powers, Farley, Fowler, Holland.
Conflict of Interest Disclosures: Dr Powers reported receiving consulting fees from AbbVie, Cardeas, Corbus, Eli Lilly and Company, Fuji Pharma Co, Ltd, Gilead Sciences, Inc, Johnson & Johnson, MedImmune, Microbion Biosciences, Otsuka Pharmaceutical Co, Ltd, Roche, Romark, and Salix outside the current work. Dr Fowler reported serving as chair of the V710 Scientific Advisory Committee for Merck & Co, Inc; receiving grant support from Advanced Liquid Logic, Basilea Pharmaceutica, Cerexa, Inc/Actavis/Allergan plc, ContraFect Corporation, Genentech, Inc, Karius, MedImmune, LLC, Pfizer, Inc, and Regeneron Pharmaceuticals, Inc; having Small Business Technology Transfer/Small Business Innovation Research grants pending with Affinergy, LLC, Locus Pharmaceuticals, Inc, and Medical Surface, Inc; serving as a paid consultant for Achaogen, Inc, Astellas Pharma, Inc, Arsanis, Inc, Affinergy, LLC, Basilea Pharmaceutica, Bayer AG, Cerexa, ContraFect Corporatoin, Cubist Pharmaceuticals, Debiopharm Group, Durata Therapeutics, Grifols, SA, Genentech, Inc, MedImmune, LLC, Merck & Co, Inc, The Medicines Company, Pfizer, Inc, Novartis International, AG, NovaDigm Therapeutics, Theravance Biopharma, and xBiotech, Inc; receiving honoraria from Green Cross International and Theravance Biopharma; and having a patent pending in sepsis diagnostics. Dr Holland reported receiving consulting fees from Basilea Pharmaceutica, Motif Bio plc, Genentech, Inc, and Theravance Biopharam and serving on a scientific advisory board for Motif Bio plc. No other disclosures were reported.
Funding/Support: This study was supported by grant R18FD005292 from the US Food and Drug Administration (FDA) and by pooled membership fees from the Clinical Trials Transformation Initiative’s (CTTI) member organizations.
Role of the Funder/Sponsor: The FDA and CTTI membership fees funded the study; members of the both the FDA and CTTI were part of the study team. The funders/sponsors contributed to the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.
Disclaimer: Views expressed in this publication do not necessarily reflect the official policies of the Department of Health and Human Services, nor does any mention of trade names, commercial practices, or organization imply endorsement by the US government.
Meeting Presentation: These data were presented in part at the 4th International Clinical Trials Methodology Conference/Society for Clinical Trials 38th Annual Meeting; May 8, 2017; Liverpool, England; and at the Public Responsibility in Medicine and Research Advancing Ethical Research Conference; November 6, 2017; San Antonio, Texas.
Additional Contributions: Katelyn P. Blanchard, BA, Duke University, provided assistance in conducting the research, and Damon M. Seils, MA, Duke University, provided editorial assistance. These individuals were compensated as part of their salaries. We thank the study participants for their time and for sharing their perspectives on this important topic with the study team.
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