Lessons Learned from ICU Research During a Pandemic: A Multisite Qualitative Study to Inform Research Innovation

doi:10.21203/rs.3.rs-4000706/v1

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Research Article

Lessons Learned from ICU Research During a Pandemic: A Multisite Qualitative Study to Inform Research Innovation

https://doi.org/10.21203/rs.3.rs-4000706/v1

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Purpose

Emergency conditions such as the COVID-19 pandemic pose complex scientific and ethical challenges for researchers, which must be addressed to optimise efficiencies in trial conduct. Our purpose was to examine key factors essential to creating an agile system responsive to the rapidly changing research and clinical environment and to understand how we might learn from this unique experience to bolster research capacity in future pandemics.

Methods

Our evaluation employed robust qualitative descriptive methodology which comprises an approach for gathering information directly from those experiencing an event or process and flexible application of theoretical frameworks to assist in the analysis. Data was collected through individual interviews of key research stakeholders and our thematic analysis was informed by the Consolidated Framework for Implementation Research (CFIR).

Results

Over 17 months, we interviewed 64 participants across four research sites. Our findings uncovered key challenges in each of the 5 constructs of the CFIR: the outer setting, the inner setting, intervention characteristics, individual characteristics and rapid implantation processes which were put in place to allow crucial research to happen under extenuating circumstances.

Conclusion

Our data demonstrate the pandemic-magnified shortcomings of a precarious research infrastructure both in local ICUs and at the national level. Focusing investment on more efficient research platforms and administration, considering research and data sharing capacity and patient and family experience in protocol development, building a robust research workforce, and revamping the funding architecture at all levels are important lessons to promote seamless delivery of critical care research in pandemic conditions.

Research infrastructure

intensive care research

pandemic research

qualitative methods

Randomized controlled trials (RCTs) remain the gold standard to guide clinical care.¹ Many integrated processes including regulatory (ethics and Health Canada), logistics, supply-chain, financial management, human resources, managing hospital culture and communications are key to clinical and trial implementation. However, emergency conditions such as the COVID-19 pandemic pose complex scientific and ethical challenges for researchers, which must be addressed to optimise efficiencies in trial conduct.^2,3 Outside of pandemic conditions, evidence generation and practice change are slow, with significant inefficiencies and high costs.⁴ Traditional research processes present a unique challenge during a pandemic given the need for greater efficiency and production of evidence in significantly shorter time frames without compromising rigour.

Three large pandemic RCTs commenced in intensive care units (ICUs) in Ontario, Canada during the COVID-19 pandemic: SAVE-ICU evaluating volatile-based sedation⁵, REMAP CAP evaluating pharmacological interventions for community acquired pneumonia including COVID-19⁶ and CATCO evaluating therapeutics for treating active COVID-19 disease in Canada⁷. These trials have common features that make them ideal for studying processes of trial implementation during a pandemic. All three are a) evaluating health technologies in critical care; b) were launched during a pandemic; c) required emergency regulatory approvals; d) required rapid implementation due to their focus on COVID-19 treatments, and e) are multi-centre.

We leveraged the ‘natural experiment’ offered by these trials to study research trial implementation processes during the COVID-19 pandemic. Qualitative research is an ideal approach as it can offer insights into why and how processes are successful (or not) and in what conditions.⁸ Our aims were to examine key factors essential to creating an agile system responsive to the rapidly changing research and clinical environment and to understand how we might learn from this unique experience to bolster research capacity in future pandemics.

Research Objective

To describe the enablers and barriers to successful implementation and conduct of RCTs in Canadian critical care settings during the COVID-19 pandemic to inform efficient, timely and safe conduct of critical care research in extraordinary times.

Study Design

Our evaluation employed robust qualitative descriptive methodology which comprises an approach for gathering information directly from those experiencing an event or process and flexible application of theoretical frameworks to assist in the analysis.⁹ In reporting this study we followed the Consolidated Criteria for Reporting Qualitative Research (CORE-Q) guidelines.¹⁰

Study Setting

This evaluation ran in parallel to the three RCTs (named above) between May 2021 and December 2022 at four academic ICU trial sites in Ontario, Canada (Sunnybrook Health Sciences Centre, Unity Health; St. Michael’s Hospital, Toronto General Hospital; and London Health Sciences Centre). Further details on the ICUs and trials are outlined in Fig. 1. Research Ethics Board approval was granted by Clinical Trials Ontario (REB 3505) with additional site-specific REB approval and data sharing agreements.

Sampling and Participant Recruitment

We used purposive sampling to recruit representative stakeholders across several roles directly involved in research trial conduct and approval. Purposive sampling is a technique widely used in qualitative research for the identification and selection of information-rich cases for the most effective use of limited resources.¹¹ Site investigators or designates sent a standardized recruitment email to identified staff and research participants personally inviting them to take part in the study. Unfortunately, due to the seriousness of the health situation for most patients and families in the ICU and pandemic restrictions, we were only able to recruit a few patients and families to speak to them directly about their experience of ICU research during the pandemic.

Data Collection

Each participant completed one semi-structured interview by phone. We based the interview topic guides (Appendix 1) on the constructs of the Consolidated Framework for Implementation Research (CFIR)¹² and our study objectives. Interview guides were tailored for each key stakeholder group enabling exploration of trial enablers and barriers to implementation from unique perspectives. At interview onset we obtained brief demographic information (e.g., age, sex, education, professional role, etc.). The semi-structured format of the interviews allowed for the generation of participant-led accounts and the selection of follow-up probing questions, question order, and phrasing of the questions varied according to the direction of the individual’s narrative.

Three research team members (MBS, CD, and KS) with extensive qualitative research training conducted the interviews. No interviewer had any prior relationship with the study participants. All interviews were digitally recorded, transcribed verbatim by an external transcription agency, and reviewed for accuracy by the research team.

Data Analysis

We used a content analysis¹³and largely deductive approach to analyze the large dataset with the CFIR guiding the coding framework. Deductive content analysis is used when the structure of analysis is operationalized on the basis of previous knowledge.¹⁴ The CFIR framework was developed to guide systematic assessment of multilevel implementation contexts and factors that might influence successful intervention implementation. The framework constructs were organized into five major domains and as applied to this study, are: 1) intervention characteristics, 2) the outer setting, 3) the inner setting, 4) the characteristics of individuals involved and 5) the process of implementation.¹² We were also open to new themes arising inductively from the data which did not fit well with the CFIR constructs. Three research team members (MBS, CD, and KS) independently analyzed the data to build the initial coding framework. The larger team was involved in in-depth reading of the coding; agreement on the final analysis framework was reached through consensus. Further analyses were performed to compare responses from different professional groups within and across study sites.

Over the course of 17 months, we interviewed 64 participants across the four trial sites. Table 1 outlines participant roles and demographic characteristics. Using the CFIR framework we categorized our findings under the 5 key constructs of outer setting, inner setting, intervention characteristics, individual characteristics as well as an added theme of rapid implantation processes which were put in place to allow crucial research to during the pandemic circumstances. The key findings are also visually represented in Fig. 1.

Table 1

Completed Interviews by Role
ICU Pandemic Trials Targets	Site A	Site B	Site C	Site D	TOTALS
Study PIs	1	2	1	1	5
Research Coordinators/Staff	4	3	3	2	12
Staff Physicians	2	0	1	1	4
Fellows/Residents	1	3	1	0	5
Nursing	1	2	2	2	7
APN/Clin Educators	0	1	0	1	2
Unit Managers	1	0	0	1	2
Allied Health	2	1	2	2	7
Pharmacy	1	3	0	1	5
Pharmacy Manufacturing	1	0	0	0	1
Research Ethics Staff/Leaders	1	1	0	2	4
Legal/Contracts Staff/Leaders	2	0	0	1	3
Research Leaders	1	0	1	1	3
Patients/FMs/SDMs	2	1	0	1	4
Total Interviews	19	17	11	15	64

Outer Setting (impact from outside the hospital)

Research infrastructure in Canada is a complex, multi-layered enterprise under typical circumstances. However, participants identified that the onset of the COVID-19 pandemic and related restrictions amplified many existing structural shortcomings. In particular, participants discussed the impact of archaic research policies, the influence of the media on public health attitudes, and limitations of the funding models (time-limited government funding, very specific calls from the Canadian Institutes for Health Research, several multi-centre COVID registries) launched in response to the pandemic on their ability to keep up with the significant increase in research in the ICU during this period.

“Part of the piece when you are conducting clinical trials is remote monitoring. You have to make sure they are following the protocol. But how do you monitor when you have no access to the institution? Before, it used to be paper – look at the charts, look at the records […] The privacy contracts had to be changed because before we could not photocopy anything.” [Research Ethics Board staff]

“….so figuring out how to encourage research funding to change nationally so that there's a bit more infrastructure and it doesn't sort of sunset with the finish of every trial [...] I think that's a really important element of the response during a pandemic that we don't have quite right just now.” [ICU Researcher/Physician]

“There’s all sorts of narratives floating around in the media which hasn’t helped so I think it’s pushed people to the extreme ends.” [ICU Research Coordinator]

Inner Setting (within the ICUs)

Both human and material resource limitations specific to research were magnified. This occurred within units as a result of pandemic restrictions on who was allowed to be physically present in the ICU or the hospital. Most research staff were considered non-essential and therefore had to work from home, which restricted their direct access to patients, families and substitute decision-makers for consent and enrollment tasks and ability to access support in dealing with the pandemic situation. Early resource limitations included lack of personal protective equipment (PPE) for non-clinical staff further impacted research staff in-person presence.

“Right at the beginning we had to close down [research] because we were deemed non-essential. But you know I think it would have been better if we had been deemed essential.” [Hospital Leader]

“A lot of our research staff stayed at home or were sent home, so you had one person here on site pretty much conducting all of the research that needed to be done for COVID.” [ICU Research Coordinator]

“We had PPE shortages, so we can't spare non-clinical staff PPE to do research because we're going to run out of masks [...] so I think a lot of the research that was conducted had to be conducted by the clinicians themselves [...] So I think that was the negative. [ICU Physician]

Visiting restrictions for family members also negatively impacted research recruitment processes since substitute decision makers were not physically present and could not be easily located for surrogate consent, a common practice in ICU research due to mental incapacity of the patient.

“Families found it overwhelming when multiple people were calling them asking their family member to be enrolled in a project.” [Other ICU Health Professional]

“Like people were not allowed to come in…and then ‘you’re calling from the hospital to ask me about a study?’.” [Other ICU Health Professional]

Existing research infrastructure across the participating institutions was highly variable. In institutions where strong relationships between staff, investigators and research operations existed, there was the perception that required changes in ways of working were less disruptive and were addressed collaboratively. However, the expectations of major adaptations to research working practices in a very short timeframe were considered extraordinary and challenging.

“A lot of people made a lot of concessions. This COVID [master agreement] was just like, "Look, this is what you need in a contract in order for everybody to basically cover off basic privacy. Cover off PHIPA [Personal Health Information Protection Act] requirements." And where a lot of people would normally step in and say, "We're not going to sign that, not until you put this in." We all kind of collectively agreed, like, "No, we have to just accept this sufficient agreement for any COVID related studies." [Legal/Contracts staff]

“Not all research ethics offices are open to having a lot of dialogue and discussions with investigators before submission. So, we've heard a lot of comments like that, that we were very– we work very well, very collegial, with our investigators.” [Research Ethics Board staff]

As noted above, research-specific human and material resource limitations exposed shortcomings in the ability to expedite trials through regulatory and contractual approval processes in additional to the timely recruitment of patients. Participants identifying themselves as researchers in our sample emphasized the importance of building and maintain an experienced team.

“You need to build your team…and it has been challenging because teams have not been consistent…we are overworked with the numbers we have.” [ICU Physician]

Intervention Characteristics

For the purpose of this study, “interventions” discussed in the CFIR framework were defined as the three clinical trials launched during the pandemic and outlined in Fig. 1 (SAVE-ICU, REMAP CAP and CAT-CO). Many participants discussed how the challenges, complexity, and opportunity costs naturally part of large RCTs conduct were magnified during the pandemic. Although the urgency to launch RCTs of COVID-19 interventions was well understood, participants identified it was almost impossible to match the resources required to implement the volume of trials needed in a short timeframe.

‘“I just think time and resources are the challenges for investigators. That is a tale as old as time over here, right?” [ICU Researcher/Physician]

“For two years, the system has been strained, but it has been at the expense of the workers. These days, we don't have nurses some nights. We don't have fellows. Residents are getting sick. Staff are getting sick. So, on top of that we need to do the research; it's become a burden sometimes. We need to consider the people who are doing the research are people too.” [ICU Physician]

“The biggest challenge was the time needed. Some of those studies...were laborious.” [Other ICU Health Professional]

Participants identified that it became clear that the research/trial infrastructure was quite fragile and easily overwhelmed. Participants recognised it was not typically designed to be flexible or resource-robust enough to consider alternative approaches to recruitment, consent, data collection or challenges such as competing or conflicting objectives and new ethical considerations.

“Having research infrastructure in place and different kinds of trial platforms I think is the future, and that requires changing funding from CIHR and maybe some investment at the provincial and federal level.” [ICU Researcher/Physician]

“And I really look forward to Health Canada's modernization plan when it actually comes out and gets rolled out because hopefully, they'll make academic research a little bit easier.” [ICU Nurse Manager]

Conversely, participants commented that being faced with a completely unknown disease and needing to find an effective treatment brought people closer together, focusing on one research topic with high reciprocity. Attitudes towards the rationale for research seemed to shift, thereby helping the process of rapid trial implementation.

“And we have such a high number of cases. We have to really be sort of poised to have all things sort of working right to get things going quickly so we can learn quickly and can help patients quickly.” [ICU Researcher/Physician]

“My thoughts are on the side that research in general is super important….in a pandemic more important than usual because now we’re stuck in a situation where we don’t really know what to do.” [ICU Research Coordinator]

Individual Characteristics - Research Staff

As described further above, clinical trials in the ICU we perceived to be constantly under resourced and many assumptions made about their capacity. Research personnel participants expressed substantial concern regarding issues such as the perception of added risk of infection and lack of personal protective equipment, the perceived mismatch between desire to participate in several COVID-19 trials simultaneously and research staff capacity, and the workload of these complex trials. These participants expressed mixed feelings about stopping non-COVID related research which resulted in a reduction in available research staff due to the redeployment and/or furlough of non-clinical hospital staff.

“It was a bit scary to enter a room [as a research coordinator] where you would have two, three COVID patients coughing with the oxygen nose mask and that kind of atmosphere. And then it was a challenge going home to kids.” [ICU Research Coordinator]

“No one was allowed in. So if you were doing [a trial], you were doing it totally on your own.” [ICU Nurse]

“We have less staff than we normally would have to do all the studies and there’s actually more active studies than ever.” [ICU Research Coordinator]

The clinical participants in this study (largely nurses) also spoke about the burden produced by the expectation that they would perform research staff in-person tasks when restrictions prevented them being in the ICU. These participants perceived an assumption was made of nurse compliance with these tasks, without engagement or communication about the purpose and status of each trial.

“So, as a clinician, my time spent with each patient is a lot higher, and the stress is a lot higher. The physical, the mental, and the emotional exhaustion that I get each day, working with these patients, is a lot higher than it was before. So, having this, and then, asking me to help with research, for me, it's not a priority. I would say, I cannot prioritize research on top of taking care of these extremely, extremely critically ill patients.” [Other ICU Health Professional]

“The nurses, they had to do all of this extra blood work. That means going in and out of those rooms more often. There was that fear of the unknown. I think that was a big challenge.” [Other ICU Health Professional]

Individual Characteristics - Patients and Families

As noted in the methods section, we were only able to interview a few patients and families due to their critical illness and pandemic restrictions, respectively. Clinical and research personnel participants however shared several views on what they perceived influenced patient and family participation in pandemic research. In the initial stages of the pandemic, families were “desperate” for any treatment that might help their relative leading to increased enrollment in COVID trials. However, participants identified a waning of interest with later waves and in particular with vaccination availability and more information about the condition. Anti-vaccination opinions among the public also impacted eligibility and willingness to participate for some trials.

“I think in the beginning they were very, very supportive…we had the highest [consent] conversion rates that I have ever seen.” [ICU Research Coordinator]

“We noticed a change over the waves. The wave two that happened in December…[patients and families] just became a little less interested in participating. Also, a lot of the answers would just be, ‘No, I don’t want to do this.’” [ICU Research Coordinator]

The few patient and family participants we were able to speak with identified interest in non-treatment focused research, for example the impact of the pandemic on basic nursing care.

“I would think that it's research on the level of nursing care that continues with the shortage of staff and what is available during the pandemic because there are very, very COVID-sick patients in the ICU. And I think that the nursing care aspect of the effect of a pandemic is so important because they're overworked, they're short-staffed, maybe the people aren't available [...] That does take away from the patient care.” [Patient/Substitute Decision Maker]

Lastly, given the initiation of numerous COVID-related trials at the same time with overlapping eligibility criteria, the challenge of concurrent recruitment became common. Research staff felt uncomfortable making multiple requests for multiple trials to the same patient and/or family, especially given the usual stress of ICU admission.

“But I think the biggest challenge in the ICU pandemic trials is probably not just the fast-paced, but really the over-approaching of participants or their family members.” [Research Ethics Board staff]

“You had three or four different people approaching them for three or four different studies in a three-hour period and just totally overwhelming people.” [Other ICU Health Professional]

Process of Rapid Approval and Implementation for COVID Trials

Given the pace at which COVID-related research was launched, participants recounted how the REB and contractual processes were rapidly modified and made significantly more efficient without losing integrity. Pragmatic efficiencies such as parallel REB and contract submission of documents for review and increased communication between research sites were perceived to introduce efficiencies.

“I think one of the things that actually made things much easier was approval turnaround time for research. I think [it] was very quick for COVID related research, which was a very different world than I think the researchers are used to in navigating that process.” [ICU Physician]

“Legal agreements. And getting the legal agreements that are all in parallel with all of these different sites signed off. That's probably the single biggest thing to work on and to fix.” [ICU Researcher/Physician]

However, a downside to the rapid approval and implementation of numerous new trials was the rise of data quality concerns and overlapping data collection requirements. Several participants discussed the problem of the collection of too much data, with too few staff and a lack of standardized data sharing between trials.

“I think it's really important when an investigator is creating a protocol if they put a lot of consideration into how to minimize impact on staff, on clinical staff. Decide ahead of time about what you need and what you're going to use. Take a second look through it and, you know, if you don't need a Mod, a Sofa, and an APACHE score. If you don't need all of those, get rid of what you don't need.” [ICU Research Coordinator]

“For some studies, there were lots of data variables and data fields to fill, and that was a bit tiring because you'd have to go to different data sources…yeah, time-consuming.” [ICU Research Coordinator]

This qualitative study of enablers and barriers to conduct of critical care trials during pandemic conditions leverages data from 64 interviews with diverse stakeholders from four large academic hospitals in Ontario, Canada. Our findings point at four key facilitating factors that can be used to inform improvements for conduct of critical care trials to enhance their capacity to cope during challenging situations such as future pandemics. These include: 1) robust yet nimble research infrastructure; 2) valuing research staff and their roles; 3) considering the impact of competing trials on resources, data quality and patient experience; and 4) developing standardized guidance/policies to generate efficiencies in research ethics, contractual, and data collection processes. In addition, participants highly recommended the reformulation of critical care research roles and teams as essential workers to facilitate research conduct under such conditions.

The critical care units we studied are well-versed in conducting large-scale clinical trials and many investigators are world-renowned trialists in intensive care medicine. However, it is not the appropriateness of trial interventions or designs that came into question under the COVID-19 pandemic, but rather the less evident impact on fragile research infrastructure and human resources. We found that local ICU research infrastructure was stretched beyond capacity in most circumstances. People, processes, and resources were not immediately in place to overcome barriers imposed by social distancing, staff redeployment, family visiting restrictions, and the uncertainty of contagion. Research team members invested significant time adapting standardized operating procedures (SOPs) to meet pandemic circumstances. The convergence of multiple competing trials added to the ethical and logistical burden of prioritizing approach for consent into several possible trials. Other authors have identified the need for a robust yet nimble clinical trials infrastructure to address these emergency pandemic issues.^15–17 Janiaud et al noted that the benefit of efficient trial administration, collaborative structures, and integration of existing data and facilities might be among the lessons and legacies of COVID-19 for future randomized trials.^17,18 We would advocate for review and reconsideration of building a more resilient research workforce, including surge capacity is needed.

We found that well defined research roles and positive social relations supported the rapid implementation of trials. Our findings support an inclusive and standardized definition of research roles as it emphasizes the interdependencies among people who must overcome temporal, geographic and institutional challenges in a pandemic to conduct clinical research. The disruption in research roles posed by social distancing, work redeployment, illness, fatigue and burnout are potent barriers to this dynamic work. We found relationships and informal communication, which is characteristic of high performing ICU teams¹⁹, to be key to successful trial conduct. Similar to prior research, we also found failure to recognise the impact of trial conduct on the work of nursing and allied health staff. This may impede recruitment, protocol fidelity, and a culture of inquiry.²⁰

Participants in this study emphasized the considerable challenge of competing trials on resources, data quality and patient/family experience and a small number of ICU team members and patients may carry a significant burden of research conduct during a pandemic. Hosting studies in ICUs burdened with high workloads and limited resources places significant strain on research and non-research staff. The human and financial costs to patients and families are also an important consideration. Competition for a small number of patients can lead to research waste. Other research suggests a rapid acquisition of new ICU trials in the first few months of a pandemic is to be expected but without prioritisation which could lead to inefficiencies and research waste.²¹ For example, an appraisal of nearly 3000 COVID-19 trials concluded that only 5% were appropriately powered to generate results useful for treatment decision-making.¹⁷

Given staff shortages and other stressors, our data lend themselves to the prioritization of simple yet large trial designs during pandemic conditions that can be easily replicated and with less impact on research personnel, clinicians and patients/families.¹⁸ National research councils committed large amounts of money to COVID-19 research since the beginning of the pandemic. In 2020 alone, the Canadian government (including the Canadian Institutes of Health Research) made a total investment of over $165 million in COVID-19 research calls.²² However, our data reflects that future government provisions should consider more stable and long-range funding models for complex, adaptive trial platforms.^23–25 This would relieve the pitfalls of funding a plethora of highly focused, small sample individual projects that place further risk on a rather fragile pre-existing research infrastructure.²⁶

Lastly, our data identified guidance for trial start up that enable ethical, contractual and data collection efficiencies in pandemic circumstances as crucial. Similar to other reports, our study participants described the temporary cessation of non-pandemic research, prioritized ethical review of pandemic research, and modifying consent for telephone, videoconferencing and email execution, as key facilitators.^27–30 An unexpected finding was a consistent delay in legal contract execution across centers. Trial start-up is a critical phase and has many opportunities for delay. Drivers of start-up delays include regulatory issues and inefficiencies in contracts and budgets.³¹ Such delays are important in the context of increased waning of patient-family interest in COVID-19 research participation over time, as reported by participants in our study. This phenomenon suggests a small window may exist for particular trials to be launched and further emphasizes the need for streamlined ethical review and legal approval processes. The issue of alternative consent models was not as prevalent in our data, however, Cook et al drew attention to similar ethical issues related to research conduct in the pandemic context in their review during the H1N1 pandemic in 2010.³²

Although published more than a decade ago, the advice noted by Cook et al in their review of critical care research during the H1NI pandemic holds true: “Just as specialists in public health, family, emergency, pulmonary, and critical care medicine are planning the appropriate clinical response to the pandemic, investigators and institutions need to plan their research response.”³² Ultimately, and in line with the recent editorial in CMAJ by Fowler and Murthy et al³³, we hope this work can contribute knowledge to the wholesale redesign of multi-centre trials in clinical care in Canada both during inter-pandemic and pandemic times. Thoughtfully organized and coordinated critical care research infrastructure with a focus on strong human resource strategies will hasten the discovery of new knowledge, reduce research waste, and renew interest and commitment of clinical teams to support world-class research in the ICU.

Strengths and Limitations of this Research

We believe this research is informative for ICU leadership and staff, research institutes, hospitals, researchers, patients and families, and for public health agencies on the national and international level. A strength of our research is that we were successful in collecting data from 64 participants with diverse roles and experiences in the research process and pandemic work. This, along with our use of robust qualitative methods and interprofessional team of analysts, strengthens the support for our interpretations and recommendations.

A second strength was our use of the CFIR Framework and its consideration of the impact of both inner and outer contexts on implementation. This theoretical view helped to organize and correlate data on a complex phenomenon from multiple perspectives. While we found the CFIR to be very helpful as a framework in organizing the massive amount of data we were able to collect, it can artificially partition things in a way that may not accurately represent the reality of the pandemic. However, we were able to identify modifiable policies and processes that facilitated trial conduct. Moreover, we described the importance of human resources and relationships in navigating an unprecedented time in health research history.

Our study naturally has its limitations. Data were limited to academic health science centres in Ontario, Canada and as such may not be reflective of the experience in other parts of the world. As well, we were not able to recruit as many patients or family members as we had hoped due to pandemic restrictions. While the patient and family experience is very important, we feel that the other participants we interviewed were able to speak to their interactions and observations of patient and family responses to research which remain informative. Lastly, obviously experiences and context changes with the passage of time and in this case with the evolution of the pandemic scenario. So, while our findings held true at the time of data collection there may be new or different challenges now that we did not capture.

The COVID-19 pandemic required significant adaptation to the critical care clinical research enterprise in research centres across the globe. Our data demonstrate this magnified the shortcomings of a precarious research infrastructure both in local ICUs and at the national level. Focusing investment on more efficient research platforms and administration, considering research and data sharing capacity and patient and family experience in protocol development, building a robust research workforce, and revamping the funding architecture at the national level are important lessons to promote future delivery of critical care research in pandemic conditions.

Funding

was provided by the Health Research Foundation.

Author Contribution

All authors were involved in study design and data analysis. K.N.D., M.B.S and C.D. were involved in data collection, drafted the main manuscript text and prepared figures and tables. All authors reviewed and edited the final manuscript.

Research Ethics Board approval for this work was granted by Clinical Trials Ontario (REB 3505) with additional site-specific REB approval and data sharing agreements.

Funding was provided by the Health Research Foundation.

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No competing interests reported.

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Lessons Learned from ICU Research During a Pandemic: A Multisite Qualitative Study to Inform Research Innovation

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Abstract

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INTRODUCTION

METHODS

Research Objective

Study Design

Study Setting

Sampling and Participant Recruitment

Data Collection

Data Analysis

RESULTS

Outer Setting (impact from outside the hospital)

Inner Setting (within the ICUs)

Intervention Characteristics

Individual Characteristics - Research Staff

Individual Characteristics - Patients and Families

Process of Rapid Approval and Implementation for COVID Trials

DISCUSSION

Strengths and Limitations of this Research

Conclusions

Declarations

Funding

Author Contribution

References

Additional Declarations

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