The aim was to describe the patient’s perspective of being examined by ARTHUR, compared to an ultrasound examination by a rheumatologist. Further, to register any safety issues with the use of ARTHUR.
Patients were included from the Department of Medicine, Section of Rheumatology, at Svendborg Hospital—Odense University Hospital. Patients were eligible for inclusion if they had RA, defined by the 2010 EULAR/ACR RA classification criteria, and were at least 18 years of age. The study is an observational cross-sectional study. Participants were identified using consecutive screening and enrollment, based on time for the patients planned regular RA activity assessment visit. Using this method, patients with planned time in the outpatient clinic, on the days where ARTHUR was installed, could thereby be enrolled in the study. The patient was first examined by ultrasound by a rheumatologist, then ARTHUR. All participants signed informed consent. Exclusion criteria were RA with severe joint destruction.
The study was initially evaluated by the regional ethics committee (ID: S-20200145), which ruled it a quality assessment project. There was no intervention in the study, so ethical approval was not needed. The study was hereafter submitted to Odense University Hospital, Region of Southern Denmark as a quality assessment project and approved (ID: 20/55294). A data user and data handling agreement regarding this study between OUH and ROPCA Holding were signed 4/12-2020. The Danish Medicine Agency evaluated ARTHUR as not to be applied as a new medical device, as all parts are CE approved and used as approved (Danish Medicines Agency (Lægemiddelstyrelsen), Ref.: 2017123702).
The rheumatologist used a GE Logiq 10 ultrasound scanner with an ML-6-15 probe from GE (GE Healthcare, Chicago, USA) for the ultrasound assessment of hands and wrists bilateral. The patients were seated with their hands resting on an examination bed (Fig. 1A). The ultrasound examination followed the EULAR guidelines .
ARTHUR is a system developed first as a University of Southern Denmark (SDU) and Odense University Hospital (OUH) project, then developed into a company called ROPCA Holding (Odense, Denmark). The version of ARTHUR used in this trial (Fig. 1B) is composed of; (1) A table with a touch screen where the hands are placed. (2) A camera to detect the individual joints of the hand. (3) A clinically approved (IEC 60601-1 and IEC 62304) robotic arm (Model: LBR Med 7 R800, Kuka Robotics, Augsburg, Germany). (4) With an attached ML-6-15 probe from GE (GE Healthcare, Chicago, USA) connected to a GE Logiq 10 scanner to record ultrasound images of the joints (Fig. 1E–H). (5) The system used a CE approved AI system, DIANA, to score RA disease activity on Doppler ultrasound images. (6) Through audio and instructions on the touch screen, the patient is guided through the process. (Fig. 1C). The patient is instructed how to apply and remove ultrasound gel in this process, one hand at a time (Fig. 1D). All examinations were observed for any safety issues.
Patient-reported outcomes (PRO)
Questionnaires were obtained after scanning by the rheumatologist and after examination by ARTHUR and were related to the patients' view of the examinations (Respectively Survey 1 and 2, see Additional file 1).
PRO data collected after examination by the rheumatologist
Gender and age were noted. Next, the patient was asked about the mood before arriving at the department (Angry, Surprised, Afraid, Sad, Expectant, Happy and Comfortable), the experience with the doctor (ranging from Good to Could have been much better with a possibility to elaborate on the answers in the free text box). The mood after the examination was then assessed (same categories as before the examination) followed by a question regarding pain during examination with ten discrete values from 0 (no pain) to10 (max pain). A follow-up question was asked to identify in which joint the pain was felt. Finally, the patient was asked about discomfort on the same 0 to 10 discrete scale followed by a question related to concerns of having an examination by ARTHUR(with five possibilities ranging from Completely unconcerned to Very concerned).
PRO data collected after ARTHUR examination
Experience, mood, pain and discomfort with ARTHUR was assessed on the same scales as after the rheumatologist. Then came a series of 6 statements regarding (Entertained, Excited, Relaxed, Freedom, Satisfied, and Confidence) during the ARTHUR examination. Each with four answer possibilities ranged from Strongly Agree to Strongly Disagree. Then came two questions on what is essential for the patient when ultrasound scanned. The patient could choose more than one answer, e.g., the ultrasound scan is fast and the doctor's presence (see Additional file 1 for all answer possibilities). Then came a question regarding sufficient patient information before ARTHUR scanning. Then came six questions, all with three answer possibilities on the graphical user interface (GUI) of ARTHUR, asking if it was clear, understandable, informative, readable, and on the colors applied. Then came two questions on the need for more entertainment during the scanning and what it should be. Then on if ARTHUR should move faster, and after that, something else should be changed in the scanning process. The last two questions were on willingness to be examined by ARTHUR again and if they would accept to be scanned by ARTHUR as a part of their future RA follow-up.
All PRO data was collected on questionnaires as categorical data. Pain and discomfort evaluations described discrete values from 0 to 10, not continuous scales. PRO data is paired, as it was the same patient, first assessed by the rheumatologist and then by ARTHUR. Statistical comparison was performed applying the marginal homogeneity test (Stuart–Maxwell test). STATA (StataCorp, Texas, USA) Version 17 was used for analysis, and p values < 0.05 were significant.