JMIR Publications

ABSTRACT

Background:

Frequent vital signs monitoring during and after transfusion of blood products and certain chemotherapies/immunotherapies is critical in detecting infusion reactions and treatment management in patients. Currently patients return home instructed to contact the clinic if they feel unwell. Continuous monitoring of vital signs with wearable electronic biosensors during and post-treatment, for hematological patients treated with immuno- or chemotherapy or receiving blood transfusions, may improve the safety profile of these treatments and make remote data collection in an outpatient care setting possible.

Objective:

To evaluate patient experience with the VitalPatch® and to evaluate usability of data generated by the physIQ accelerateIQ™ monitoring system for the investigator and nurse.

Methods:

Twelve patients with hematological disorders receiving either red blood cell transfusions, an IV proteasome inhibitor or an IV immunotherapy agent were included and wore the VitalPatch® for 12 days. Patients and nurses completed questionnaires focusing on wearability and usability, respectively, of the VitalPatch®.

Results:

Twelve patients were enrolled over nine months (4 receiving red blood cell transfusion, 4 IV proteasome inhibitor and 4 IV immunotherapy). Diseases for which these patients were treated consisted of multiple myeloma, myelodysplastic syndrome and non-Hodgkin lymphoma. Of these patients, 83% were aged 60 and above. Four patients (33%) withdrew from the study (3 due to skin irritation, 1 due to patch connection issues). Patients wore biosensor patches at baseline and for one-week post-administration data. Patient reported outcomes (PRO) were collected at baseline, day 1, 5 and 8. No difference in the PRO were observed when nurses or patients applied the patch. PRO data indicate minimal impact on patient’s life. Ease of use, influence on sleep, impact on follow-up of health or discomfort with continuous monitoring did not change between baseline and day 8. Changes in PRO were observed on day 5, where 20% increase in skin irritation was reported. Withdrawals due to skin irritation were in all cases reported when wearing the second patch. Nurses reported placement of the VitalPatch® to be easy and felt measurements to be reliable.

Conclusions:

Generally, the VitalPatch® was well tolerated and showed to be an attractive device due to its wearabilty and little impact on daily activities in patients, therefore making it suitable for implementing in future studies.