Mobile X-ray examination takes place outside the hospital setting using transportable X-ray equipment. It is offered to patients when a transfer to the hospital at the radiology department may be an obstacle, and the referring doctor, therefore, considers it preferable for the patient to be examined in their homes. Mobile X-ray is used in countries including Norway, Sweden and Italy [1] - [8]. In Aarhus Municipality of Denmark, elderly patients living in aged care facilities have been offered mobile X-ray examination since the year 2014 [9]. Patient’s frailty is the reason why they are offered mobile X-ray.

Patient satisfaction is important for compliance with care, continuity of care, and the relationship with the care giver [10] [11]. Various validated and general tools have been developed to explore the patient’s experience with the given care, such as the “Quality of Care through the Patient’s Eyes” and the “Consumer Assessment of Healthcare Providers and Systems” surveys [12] [13]. Unfortunately, the questionnaires in these tools are intended to measure the experience of care at the meso level of healthcare and not satisfaction with the examination. Even though measuring patient satisfaction is challenging, it is important in order to improve and assure the quality of care in the use of mobile X-ray. Therefore, a tool specifically developed using questions concerning patient’s satisfaction is needed [14].

Qualitative and quantitative studies report that patients, relatives and healthcare staff are satisfied with mobile X-ray [2] [7] [8] [15]. Eklund studied patient’s satisfaction in a descriptive study, but only half of the patients were able to respond [2]. Ricauda studied patient’s satisfaction in a pilot Randomized Controlled Trial (RCT), and reported a high level of satisfaction, but the authors did not describe the data collection methods [7]. Vigeland studied satisfaction by interviewing the referring doctors, but not the patients [8]. A commonality of the studies is that they report a high level of satisfaction with using mobile X-ray.

Measuring patient satisfaction is complex due to the multiple variables affecting satisfaction, especially in a frail and very ill patient population. Therefore, determining how to measure patient satisfaction was a challenge. In a pilot questionnaire study of 10 aged care facility patients, we asked questions concerning the patients’ moods or physical aspects, which were possible for the patients to answer. However, in terms of questions concerning the X-ray examination, some of the patients did not even know that they had been examined and therefore were unable to answer questions concerning their satisfaction with the examination, probably because the majority of the patients were very frail and had cognitive impairments [16].

Our aim was to investigate whether patients in aged care facilities, who were offered mobile X-ray, were more satisfied with the X-ray examination compared to patients examined with X-ray at the Department of Radiology at Aarhus University Hospital.

Patients were recruited from nursing homes and homes for the elderly in Aarhus Municipality. Patients were eligible for inclusion if they had been referred for a mobile X-ray examination.

Patients hospitalized at the University Hospital, homeless patients, handicapped patients and patients already examined with mobile X-ray in the study period were excluded.

We had several ethical considerations in conducting a RCT in this study population, because the patients were fragile. The patients needed a mobile X-ray examination because of a referral and therefore, it may not have been ethically appropriate to offer them an X-ray at the hospital, as the patients may not have been able to attend their appointment. On the other hand, had mobile X-ray not existed, the patient would not have been offered a mobile X-ray and therefore would have had to be examined with X-ray at the hospital. Also, mobile X-ray was not offered with solid evidence and therefore, the patients were randomized in order to study the evidence of mobile X-ray, where half of the patients were examined with mobile X-ray and the other half was examined with X-ray at the hospital. Therefore, we thought that it was ethically appropriate to randomize the patients.

The study was approved by the Ethical Committee (53,811) and Data Protection System (1-16-02-124-15) in the Central Denmark Region and registered at https://clinicaltrials.gov/ (NCT04005040). Involved departments at Aarhus University Hospital gave their consent for examining the Electronic Patient Journal (EPJ). Informed consent was not obtained because the study was approved as an organizational study by the Ethical Committee.

After the patients were referred for mobile X-ray, they were randomized to either be examined with mobile X-ray in their own home (nursing homes or homes for elderly) or X-ray at the University Hospital, at the Department of Radiology. The computer program Redcap was used to randomize patients via a computer-generated block randomization with blocks of eight patients in each group. It was not possible to blind anyone in the study due to the characteristics of the intervention.

The inclusion period started on May 1, 2018 and lasted until April 12, 2019. In that period, 177 patients were randomized to be included in the study. Of the 177 patients, 43 patients were excluded due to not fulfilling the inclusion criteria and three patients were excluded because they did not complete the examination. A total of 131 patients were included as treated and of those questionnaires were answered on behalf of 66 patients in the intervention group and 63 patients in the control group. In Figure 1, patient inclusion flow is shown.

The intervention group comprised patients examined using mobile X-ray in their own home/institution and their careers, who answered the questionnaire.

The control group comprised patients examined using X-ray at Aarhus University Hospital and their careers in their respective nursing homes, who answered the questionnaire.

In 2015, we conducted an evaluation of mobile X-ray, where we measured satisfaction using self-developed questionnaires for patients, relatives and healthcare staff. The items were formulated using knowledge from the literature and observations from our own project [2] [5] [7] [8] [9] [15] [16] [20]. In the evaluation, we concluded that the questionnaires needed to be further developed [9]. The further development of the questionnaire was based on observation studies and interviews to develop the questions.

Observation studies of 10 patients (selected patients who were examined with mobile X-ray or X-ray at the hospital) and interview studies of 10 different healthcare staff, four patients and two healthcare staff were conducted to gain knowledge to further the development of the existing questions. In that process, we found that relatives did not participate in the examination as often as we thought. Many of the patients were too fragile to answer questions concerning satisfaction.

From the knowledge gained in the observation and interview studies, we decided to develop a questionnaire for patients, where healthcare staff would be asked to answer on their behalf. We used the knowledge gained from the evaluation, literature, observations and interviews to develop new questionnaires for patients, relatives and healthcare staff [2] [6] [7] [8] [9] [15]. This resulted in 13 questions.

A pilot was conducted with 10 participants including both patients and staff. We tested the questionnaire using both a binary yes/no answer category and Likert style scale. The pilot confirmed that patients were not able to answer questions concerning the examinations. The response from the majority of healthcare staff was that answers should be expressed on a scale. None had time for writing comments. We ended up with five different answer categories and included 13 questions related to patient experience for patients and one question related to healthcare experience for healthcare staff. In the questionnaire, patients are called citizens because this is the term used by nursing homes in Aarhus Municipality. After the pilot, the final questionnaire was tested on five random healthcare staff members and afterwards, we conducted the study [21] [22].

In order to analyze satisfaction and understand mobile X-ray, we categorized the questions into themes inspired by the literature and from our own observations, interviews and pilot study [2] [7] [8] [9] [15]. The answers to questions 1 - 3 expressed overall satisfaction with X-ray in general. Questions 4 - 9 were about satisfaction with the X-ray examination. Questions 10 - 12 were about satisfaction concerning circumstances after the X-ray examination and question 13 dealt with the possible mental effects following the patient’s X-ray examination.

The data collector in the observation study, interview study and the questionnaire pilot was the same researcher. This researcher also administered the questionnaire, which healthcare staff answered. The researcher developed the observation guide, interview guide and questionnaires in cooperation with the supervisors and staff at the Department of Radiology.

The data of the final questionnaire were collected by a data collector trained for the purpose. Before the data collection started, the data collector was trained in using the questionnaire on a similar study population. The data collector had no interest in the final results.

The data collector collected data within a week after the X-ray examination in the patients’ homes.