Abstract
Background and aims
The SARS-Cov-2 virus (COVID-19) has not only threatened the health of the world's population but also presented challenges for conducting human subject research studies. Although many institutions have now established guidelines for conducting research during the COVID-19 pandemic, reports of the practical experiences of researchers are limited. This report presents the challenges nurse researchers encountered when conducting a randomized controlled trial to develop an arthritis self-management application during the COVID-19 pandemic in Taiwan and how researchers responded to the challenges.
Methods
Qualitative data from five nurse researchers were collected from August 2020 to July 2022 at a rheumatology clinic in northern Taiwan. This collaborative autoethnographic report was drawn from data comprised of detailed field notes and weekly discussions regarding research challenges we were confronting. Data were analyzed to determine successful strategies employed to overcome the challenges and allow for completion of the study.
Results
Minimizing the risk of exposure to the virus for researchers and participants resulted in four major challenges to conducting our research: patient screening and recruitment, delivery of the intervention, obtaining follow-up data, and unanticipated budget increases.
Conclusions
Challenges reduced sample size, altered intervention delivery, increased time and money beyond what was originally budgeted, and delayed completion of the study. Adapting to a new healthcare environment required flexibility for recruitment, alternate means of providing intervention instructions, and an awareness of disparities in participants' internet proficiency. Our experiences can serve as an example for other institutions and researchers faced with similar challenges.
Keywords: Challenges, COVID-19, Nursing research, Pandemic, Rheumatoid arthritis, Qualitative study
1. Introduction
The coronavirus disease (COVID-19) is a highly infectious disease caused by the Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) (WHO, 2022). Since it was first reported in December 2019, the impact of the COVID-19 pandemic on global health has been unprecedented (Nicola et al., 2021; WHO, 2022) and has included the deaths of hundreds of thousands of people. Collateral effects of COVID-19 include enforced isolation from loved ones, mental health challenges, financial hardships, and loss of employment (Brooke & Clark, 2020; Nicola et al., 2021; Sohrabi et al., 2021).
The COVID-19 pandemic not only affected the delivery of healthcare (Shobassy et al., 2022), but also health-related research, which included delays in the research process, modifications in study designs, data collection methods, interventions, and data analyses (Im et al., 2021; Perrins et al., 2021; Pigott et al., 2021). Even in well-staffed hospitals with supportive professional environments, healthcare workers were faced with constant worry about exposure for themselves, their patients, and family members due to the highly contagious nature of the virus (Lake, 2020). This worry about exposure to the virus also made many patients reluctant to visit healthcare facilities (Shobassy et al., 2022).
The numerous challenges for conducting human subjects research brought on by the COVID-19 pandemic had a severe impact on the advancement of research (Abshire et al., 2021). As a result, hospital and research institutions carefully defined and allocated essential research activities, and all non-essential research inevitably came to a halt (Sohrabi et al., 2021), which influenced all research projects (Palese et al., 2021; Sohrabi et al., 2021). Research studies were impacted by lower response rates during data collection, delays in intervention implementation and, often, lower adherence rates to research protocols (Palese et al., 2021).
Although many institutions were quick to established guidelines for conducting research when COVID-19 was increasing, Taiwan managed to minimize the impact of the SARS-Cov-2 virus during the initial 6-months of the pandemic due to its stringent control measures. Thus, infections and deaths were not prevalent in Taiwan until May 2020, when healthcare restrictions were imposed (Taiwan Centers for Disease Control, 2020). These restrictions led to a massive change in Taiwan's outpatient clinics, as all non-urgent appointments and control visits were significantly curtailed.
Most outpatient clinics in Taiwan are located inside the hospital and reached via a public lobby and elevators. Therefore, patients feared visiting the hospital (Ministry of Health and Welfare, 2022). In the face of these difficulties, research was frequently interrupted with the ebb and flow of the prevalence of COVID-19, preventing successful completion of many research projects. Our research group began a randomized controlled trial (RCT) in August of 2020 to evaluate a self-management program for patients with rheumatoid arthritis that would be delivered as a web-based mobile application (App).
The COVID-19 pandemic presented our research group with a unique situation comprised of barriers to undertaking our study that had not previously existed and will most likely continue until the virus is contained. Therefore, the purpose of this report is to present the impact of the COVID-19 pandemic on our research by describing the challenges of conducting our RCT and our groups' responses to the challenges during this unprecedented period of healthcare research. We believe that our experiences and lessons learned may be helpful to other institutions and researchers who are facing similar challenges during this pandemic.
2. Methods
2.1. Study design and setting
This collaborative autoethnographic report draws on qualitative data collected from August 2020 to July 2022. Autoethnography is useful in qualitative nursing research because it allows examination of the researcher's own experience in a cultural context (Peterson, 2015). The study was approved by the institutional review board of the study hospital in Taiwan (IRB No. 201702125B0).
2.2. Participants
A total of five nurse researchers were involved in this study; all had experience in qualitative and quantitative nursing research (range: 2–16 years); all were female; and their mean age was 40 years (SD = 14.67; range: 25–56). Four of the researchers had degrees in nursing; one had a bachelor's degree, one a master's degree, and two with a doctoral degree. The fifth researcher had an advanced degree in Applied Foreign Languages.
2.3. The self-management program for adults with rheumatoid arthritis
The description of the study is provided to offer the context for the challenges that arose when the program was initiated as well as challenges that occurred as the study progressed. The program was originally designed as a year's-long project.
The program was based on two qualitative studies, which explored patient needs and recommendations for self-management of rheumatoid arthritis (Chen, Yu, Kao, & Shao, 2022; Chen, Yu, Lee, & Shao, 2022). The study was to be conducted as a two-arm exploratory RCT with an intervention and control group with data collected at enrollment (baseline) and a follow-up at 12 weeks. As this was an exploratory RCT, there was no sample size calculation (Craig et al., 2013). Our goal was to recruit 80 participants for this study, which was based on the sample size from previous studies that evaluated a web-based rheumatoid arthritis self-management program and ranged from 33 to 106 participants (Shigaki et al., 2013; Smarr et al., 2011).
Patients were invited to participate in the study if they met the following criteria: 1) a diagnosis of rheumatoid arthritis; 2) ≥20 years of age: 3) stable disease for at least 3 months, as determined by the patient's rheumatologist; 4) able to communicate with the researcher, and 5) the ability to use a smartphone. Eligible patients were approached for recruitment by research assistants when they were admitted to the rheumatology departments of the medical center. If the patients agreed to participate in the study and signed informed consent, they were randomly assigned to the intervention or control group using a computerized allocation procedure in SPSS 22.0 for Windows. Data for the RCT were collected with individual face-to-face interviews, which were collected when patients agreed to participate (baseline), and at 8- and 12-weeks after conclusion of the web-based intervention.
2.4. Collection of qualitative data from nurse researchers
As the nurse researchers realized they were facing unique challenges for recruiting participants and implementing the intervention program, it was decided that we should collect data about our personal experiences. All researchers maintained detailed field notes describing as many situations as possible, what were considered to be challenges, and how we were able to resolve these challenges. Details of challenges were recorded as they arose. We also decided to conduct weekly group discussions, which allowed us to share our experiences, challenges, and coping strategies. Meeting records of these weekly meetings were maintained by the primary investigator.
2.5. Data analysis
Data from 42 field notes, personal impressions and 31 meetings were reviewed, and the content was analyzed using the method of Graneheim and Lundman (2004) to evaluate the qualitative data and extract categories. Notes and meeting records were analyzed independently by the first and correspondence authors line-by-line and manually assigned codes for the key categories of the challenges; coding was not managed with a software program. Challenges faced during data collection were identified and highlighted and similar codes were grouped into main categories. The second author and another researcher checked and discussed the identified categories. If there were any disagreements, these were resolved through discussions between the two authors and outside experts in content analysis and categories were revised until consensus was reached.
3. Results
Four challenges to conducting our research during the COVID-19 pandemic were identified: screening and recruiting patients, delivering the intervention, conducting follow-ups, and unanticipated budget increases. The components of these challenges are presented below and summarized in Table 1 .
Table 1.
Overview of the challenges for conducting nursing research during COVID-19.
| Challenges | Components |
|---|---|
| Screening and recruiting patients |
|
| Delivering the intervention |
|
| Follow-ups and data collection |
|
| Unanticipated budget increases |
|
3.1. Screening and recruiting patients to participate
The greatest barrier to our research was the challenge of screening potential participants to recruit an adequate sample size. Our intention was to recruit 80 participants. Typically 40 patients per month were seen in the outpatient clinic pre-pandemic. However, the appearance of COVID-19 caused a sudden drastic reduction in patients available due to social distancing requirements; there were months when no patients appeared in the clinic. Ultimately, only 50 patients were recruited to participate. Other contributing factors were intermittent suspension of the study five times over two years; limited supplies of personal protection equipment (PPE); and reduced cooperation between research personnel, hospital staff (who were a source of referrals), and potential participants.
Social distancing requirements also resulted in competition for space to screen and recruit patients. COVID-19 caused the outpatient clinic to be prioritized for return visits of clinic patients; screening, recruitment, and patient randomization for our study was secondary. We also had to limit the number of research assistants in the clinic, which reduced our efficiency. We resolved this challenge by submitting a request to the hospital for another research site that could be used exclusively for our study. However, the research application process, communicating with the new hospital, and training new researchers added another 2-month delay to our study.
Attitudes of the patients further reduced the number of patients we were able to recruit during the pandemic. Patients were fearful that entering the hospital or interacting with researchers would expose them to the virus. Thus, many were unwilling to participate due to a desire to limit their time in the hospital to only scheduled medical appointments. Other patients had concerns that having rheumatoid arthritis, an autoimmune disease, put them at high-risk for developing complications from COVID-19. In addition, some patients were fearful of exposure to the virus and scheduled virtual online consultations and follow-up, an option instituted during the pandemic. Thus, these patients could no longer be recruited by our research team as potential participants. We reached out to patients to acknowledge their concerns and ensure them that we were following all pandemic prevention guidelines and that they would not be in close contact with the researcher.
Finally, in March of 2021, vaccines became available. Hospital policy required all staff to be vaccinated, including researchers. Availability of vaccines was limited during the early period of release, which caused another interruption to recruitment. Research assistants were lower on the priority list for vaccinations, and some researchers were exposed to the virus and needed to quarantine. We resolved this problem by hiring additional research assistants to increase our research manpower.
3.2. Delivering the intervention
Delivering intervention instructions to participants during the COVID-19 pandemic was a second challenge. Our research team had developed an online rheumatoid arthritis self-management program that was accessed by a mobile App. Our aim was to determine if use of this mobile App could enhance self-management skills for an intervention group when compared with a control group. Online data from the self-management program needed to be uploaded to the App on each participant's cellphone in the presence of a researcher and required at least 30 min. If there were difficulties with data transfer or usability, some participants discontinue the intervention program because they were fearful of interacting with researchers when they needed assistance for troubleshooting. Based on group discussions, we solved this challenge by providing immediate 24/7 telephone consultations with internet technology (IT) experts to resolve systemic problems on mobile phones and providing written instructions to assist participants in understanding and accepting the intervention program.
3.3. Follow-ups and data collection
The effectiveness of the self-management program required assessments 8- and 12-weeks after initiation of the intervention for post-test data collection. However, many participants delayed or missed scheduled follow-up appointments, which presented another research challenge. Typically, follow-up appointments are scheduled when the intervention is initiated to facilitate coordination of post-test evaluations. However, the failure of some patients to return to the clinic for these follow-up visits resulted in a loss of study participants.
Other participants were lost to follow-up because the pandemic prompted them to move to rural areas to reside with family members. When contacted by telephone, these participants reported they wanted to limit exposure to the virus and be able to receive support and care from family if they were to become ill. Participants could not be persuaded they would be safe at the clinic, thus rescheduling attempts for follow-ups were unsuccessful; the loss of these cases was unavoidable. The combination of difficulty in obtaining follow-up data and loss of participants challenged data collection and completion of our study. We requested extensions from both the Ministry of Science and Technology (MOST) and the IRB, which allowed us to complete our study at a time much later than planned.
3.4. Unanticipated budget increases
The new hospital site, hiring of additional researchers and IT experts, and additional time for collecting follow-up data presented a fourth challenge: unanticipated additional expenses. The most significant increase was the additional labor costs, which increased salaries by approximately $16,000 USD. The new recruitment site also increased transportation fees by approximately $1000 USD and additional equipment, including new computes, was needed to supply the site, which cost about $2000 USD. In total, our research budget increased by about $19,000 USD. Our research team was fortunate to receive additional funding through an application to the university involved in the study.
The challenges and our solutions are summarized in Fig. 1 .
Fig. 1.
Challenges and solutions for COVID-19-related disruptions in randomized control trial implementation.
4. Discussion
The COVID-19 pandemic has been a unique period for healthcare, and no one could have predicted the length of time it impacted the world. Implementation of collaborative autoethnography allowed our group to examine how our personal experiences were impacted by COVID-19 (Peterson, 2015). This report focused on the challenges our research group encountered and how we responded to illustrate how nurse researchers were able to negotiate barriers to conducting a RCT. The persistence of the pandemic prevented continued recruitment of patients, the sample size became smaller than planned, delivery of the intervention was affected, and the research budget increased. To the best of our knowledge, this is the first autoethnographic report using a qualitative approach to explore COVID-19-related disruptions to implementation of a RCT in Taiwan. Our findings provide a window into the nursing research community as it attempted to respond to the challenges brought forth by this unprecedented health crisis.
The challenges of Covid restrictions initiated by the hospital and imposed on the outpatient clinics resulted in prolonging the timeline of our research. Other groups have reported similar challenges, which have included shifts in patient care and screening facilities and alterations in waiting areas and clinic spaces to account for the need to maintain social distancing (Abshire et al., 2021; Bernacki et al., 2021; Sohrabi et al., 2021).
The reluctance of patients to participant due to fears of interacting with unfamiliar research staff was understandable. Fears of COVID-19 and social distancing concerns hindered other groups who attempted to recruit, enroll, and retain participants for research studies (Abshire et al., 2021; Marcum et al., 2020). The lack of motivation of the patients who were approached to participant in our study echoes the findings of Abshire et al. (2021), who reported patients had no enthusiasm for participating in a research study because avoiding Covid was their goal.
Retaining participants was also difficult as many moved to more rural areas to avoid contact with unfamiliar people, decrease the possibility of infection, and the desire to be near family members if they became ill and could not care for themselves. This finding is unique from other studies. Family members in Chinese cultural societies depend on one another for support and caregiving during periods of illness or chronic disease (Chen & Shao, 2012; Shao et al., 2015). The responsibility for family members to act as caregivers is deeply ingrained in Chinese societies that are strongly influence by the philosophy of Confucius, which requires filial piety and dictates children have the responsibility of caring for older family members (Chen & Shao, 2012).
Participants were disinclined to reach out for help from researchers when technical problems with the intervention program arose. Jairath et al. (2021) has noted patients consider it burdensome to engage researchers during a public health crisis such as COVID-19 due to a lack of time and desire to participate in lengthy interviews. Butts et al. (2022) suggest a more participant-centered approach to ensure that benefits outweigh the risk of participation as much as possible.
Modification of the intervention, and delays in data collection and analysis are similar to other's experiences (Im et al., 2021; Palese et al., 2021; Sohrabi et al., 2021). One of our immediate solutions was to apply for a research extension from the MOST and IRB. Although others have reported granting agencies and IRBs slowed or were temporarily halted during COVID-19 (Im et al., 2021; Jairath et al., 2021), each of our four requests were accepted within 1–2 weeks. This was because the granting agencies and IRB in Taiwan had converted to a highly efficient online system just prior to the pandemic. As hospital policies changed in Taiwan to accommodate Covid restrictions many studies were discontinued. To overcome this problem, we applied to use facilities at an additional hospital as a means of recruiting participants. Once again, our request was immediately granted.
Data collection posed unique challenges for our research group. Experts have emphasized the need to increase the availability of online data collection strategies (Abshire et al., 2021; Butts et al., 2022; Im et al., 2021; Lake, 2020; Palese et al., 2021). Marcum et al. (2020) suggested cell phones, online meetings, emails, text messaging, social media, or online surveys. Perrins et al. (2021) used digital platforms to deliver and receive completed questionnaires; Jairath et al. (2021) suggested telephone interviews for data collection. However, web-based or phone-based strategies were not reasonable for our study due to the need for in-person evaluation of each participant's joint condition and face-to-face interviews were needed to collect data from questionnaires. This need for in-person evaluations stems from the fact that 33 % of patients with rheumatoid arthritis in Taiwan have less than a 6th-grade educational level (Shao et al., 2021).
Despite its strengths, this report had some limitations. First, data were collected from only two recruiting hospitals, which limits generalization of our findings to other regions of Taiwan. Second, each country experienced its own unique situations during the pandemic, which may have resulted in different experiences for nurse researchers. Third, the pandemic forced us to suspend our trial five times, resulting in a small sample size, which made our findings difficult to interpret. Therefore, we were limited to sharing the challenges to conducting the research and our response to these challenges, which excludes the outcome of our RCT.
5. Conclusion
Without effective strategies to overcome the challenges posed by COVID-19, the critical scientific progress and advancements needed to improve healthcare may stall and not reach their full potential. The COVID-19 pandemic presented us with multiple challenges. To adapt to ongoing challenges, we suggest greater flexibility and adaptability from designing the research study to collecting and analyzing the data. We suggest efficient research timelines and flexible application processes for research funding. Our experiences in pivoting research during the COVID-19 pandemic can serve as a helpful example for the nursing research community as it attempts to respond to the challenges brought forth by this unprecedented crisis.
Authorship statement
All authors listed meet the authorship criteria according to the latest guidelines of the International Committee of Medical Journal Editors and all authors are in agreement with the manuscript.
Funding statement
This work was supported by the Ministry of Science and Technology, Taiwan (MOST 107-2314-B-255-003-MY3).
Ethical approval
This study was approved by the Institutional Review Board, Chang Gung Medical Foundation (No. 201702125B0, Date of Approval: 2018/01/08).
CRediT authorship contribution statement
Jung-Hua Shao: Conceptualization, Methodology, Visualization, Investigation, Supervision, Validation. Kuang-Hui Yu: Conceptualization, Methodology, Data curation, Writing – original draft. Su-Hui Chen: Conceptualization, Methodology, Data curation, Writing – original draft, Writing – review & editing.
Declaration of competing interest
The authors have no financial or other interest in the product or distributor of the product conflict of interests.
Sources of outside support for research: This work was supported by the Ministry of Science and Technology, Taiwan (MOST 107-2314-B-255 -003-MY3).
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