Abstract
BackgroundRed blood cell (RBC) transfusion is frequently employed in both ambulatory and hospital environments with the aim of improving patient functional status. In the ambulatory setting, this practice is particularly common in patients with malignancy due to anemia associated with their cancer therapy. Increasingly, the efficacy of this US$10.5 billion per year practice has been called into question. While it is often standard of care for patients with chemotherapy-induced anemia to receive ambulatory RBC transfusions, it is unclear to what extent such transfusions affect home functional status. It is also unclear whether or not changes in functional status in this population can be objectively quantified using wearable activity monitors. We propose to directly measure the impact of outpatient RBC transfusions on at-home functional status by recording several physiological parameters and quantifiable physical activity metrics, e.g., daily energy expenditure and daily total step count, using the ActiGraph wGT3X-BT. This device is an accelerometer-based wearable activity monitor similar in size to a small watch and is worn at the waist. Study participants will wear the device during the course of their daily activities giving us quantifiable insight into activity levels in the home environment.Methods/designThis will be a randomized crossover pilot clinical trial with a participant study duration of 28 days. The crossover nature allows each patient to serve as their own control. Briefly, patients presenting at a tertiary medical center’s Ambulatory Infusion Center (AIC) will be randomized to either: (1) receive an RBC transfusion as scheduled (transfusion) or (2) abstain from the scheduled transfusion (no transfusion). After an appropriate washout period, participants will crossover from the transfusion arm to the no-transfusion arm or vice versa. Activity levels will be recorded continuously throughout the study using an accelerometry monitor. In addition to device data, functional status and health outcomes will be collected via a weekly telephone interview. The primary outcome measure will be daily energy expenditure. Performance metrics, such as step count changes, will also be evaluated. Additional secondary outcome measures will include daily sedentary time and Patient-reported Outcomes Measurement Information System (PROMIS) Global 10 Survey scores.DiscussionThis trial will provide important information on the feasibility and utility of using accelerometry monitors to directly assess the impact of RBC transfusion on patients’ functional status. The results of the study will inform the merit and methods of a more definitive future trial evaluating the impact of ambulatory RBC transfusions in the target population.Trial registrationClinicalTrials.gov, identifier: NCT02835937. Registered on 15 July 2016.
Highlights
Red blood cell (RBC) transfusion is frequently employed in both ambulatory and hospital environments with the aim of improving patient functional status
The results of the study will inform the merit and methods of a more definitive future trial evaluating the impact of ambulatory RBC transfusions in the target population
Aims and objectives Primary In light of the ongoing equipoise regarding the efficacy of RBC transfusion in the ambulatory setting, the known risks associated with blood product administration, and the availability of innovative technologies that are able help to address these concerns, the primary aims of our proposed protocol are as follows: Specific aim 1: to evaluate the impact of RBC transfusion on home functional status as assessed by physical activity metrics recorded by a wearable ActiGraph wGT3X-BT mobile health (mHealth) device
Summary
Blood product transfusion is a frequently employed medical practice, with an estimated 5 million patients [28] annually receiving blood in the US alone. In addition to the strengths of the trial noted above, we acknowledge potential weaknesses of the protocol Such limitations include concerns relating to the detectability of activity level in what may often be a sedentary population with variable daily activity levels, risk that the effect from transfusion may exceed the 1-week washout period, and difficulty in recruiting patients who will be willing to consistently wear a monitor for 28 days. Though we acknowledge these potential challenges, the insights gleaned will greatly facilitate the potential design and conduct of a future, more definitive, clinical trial.
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