Nurse Researchers Make The Case For “Real-Time Toxicity” Teams in Bone Marrow Transplantation

Linh Nguyen BSN, RN, OCN, BMTCN

Nurses, first and foremost, are patient advocates, asserted Linh Nguyen BSN, RN, OCN, BMTCN, in a presentation as part of the nursing track at the 2023 Tandem Meetings. As such, prospective data collection offers a more effective method of translating patient experiences into clinically relevant data points.

“[With prospective collection] not only do we capture the individual patient experiences more accurately in real time, but we are creating a robust data set that is more representative of all transplant patients,” Nguyen, who is a clinical research nurse at Memorial Sloan Kettering Cancer Center, said during the presentation.

Bone marrow transplantation (BMT) is an intensive therapy. Many patients undergoing BMT develop adverse events in response to the associated conditioning medications, infections, or engraftment. However, according to Nguyen, the toxicities associated with BMT, which can be complex and concurrent, are both difficult to capture and comprehend retrospectively.

Retrospective collection represents the most common approach to toxicity assessments. This strategy is inexpensive and does not require daily or frequent attention. However, it is time-consuming. Moreover, the interpretation of the data can become variable; data often can be lost, methodology of collecting can vary, and it can be difficult to verify the data and to standardize the quality of the data collected.

In contrast, prospective collection is an iterative process where data is collected and updated in real time. Unlike retrospective collection, this method has less variability in interpretation and quality. It is also easier to verify the data. Prospective collection is a continuous collection process. The downsides to this approach are that it requires both ongoing training, and a dedicated team, and that implementation takes time to master.

In the prospective collection model presented by Nguyen, inpatient autologous and allogeneic stem cell transplant recipients were followed. These patients consented to clinical data collection protocol. Exclusion criteria included receipt of CAR T, germ cell, or immune effector cell therapy. Readmitted transplant patients were also not included. The common terminology criteria for adverse events were used to classify the toxicities.

The pilot study encompassed phases as follows:

• Preadmission: A pretransplant workup where patients consented to and registered to standard of care data collection protocol.
• Inpatient admission: The research nurses conducted rounds with the clinical team and identifies, graded, and attributed toxicities in real-time. This occurred twice weekly. Toxicities were then entered in the clinical research tab in the electronic medical record. Skin examinations, with pictures, were also conducted weekly.
• Outpatient follow-up: During the pilot phase, the goal was to collect toxicities through day 100. Patients who were readmitted with toxicities were followed until day 100.
• Consensus: Weekly toxicity consensus meetings were conducted, at which point the MD reviewed and verifies toxicities and a research project associate aggregated data for analysis.

Of note, one of the initiatives with this pilot program was to report adverse events as disease or syndromes whenever possible vs reporting individual symptoms or abnormality. For example, a report of grade 3 sepsis was preferred over reporting that a patient had a positive blood culture, fever, and hypoxia. Similarly, instead of reporting that a patient had pleural effusions, hypoxia, and a grade 2 cough, a report of a grade 4 lung infection was preferred.

Fevers represented another opportunity to improve specificity throughout the program. As part of the initiative, nurses were encouraged to identify the type of fever a patient was experiencing.

“As transplant clinicians we know that fevers are common transplant complication,” Nguyen noted. “When a patient's [has] a fever, we start asking ourselves several questions. Is a patient neutropenic? Or are they in grafting? Is there a positive blood culture? And are there other associated signs or symptoms?”

“It’s important to distinguish fever because this symptom can be part of a larger syndrome,” she added. “Again, we want to capture the entirety of a patient’s clinical status. We have to take all of these things into account when looking at fever [and] we know that in transplant a fever is never straightforward.”

Nursing Implications

According to Nguyen, the real-time toxicity greatly improved her nursing practice.

“As a nurse first and foremost, my job is to be a patient advocate,” she said. “This project challenged me to be a better listener, and therefore a better clinician and researcher and empowered me to tell patients stories through high quality data.”

She concluded her talk by noting that nurses play a pivotal role in clinical research projects, and that innovations such as the real time toxicity team highlight a unique way in which nurses can help translate patients experiences into clinical data points that can guide treatment decisions and future research. Moving forward, her team hopes to continue to prospectively collect toxicity data for up to one year and begin to include more patients in the outpatient setting as well.

Reference

Nguyen L, Hanley DM, Kamrowski A, et al. Prospective collection of adverse events in patients undergoing HCT: the real-time toxicity team. Presented at: 2023 Tandem Meetings and Transplantation & Cellular Therapy Meetings of ASTCT and CIBMTR; February 15-19, 2023; Orlando, FL.