Study design and participants
This study was registered at the University Hospital Medical Information Network center (ID: UMIN000035448), and the report was based on Consolidated Standards of Reporting Trials (CONSORT) .
The study was conducted with the approval of the Ever Walk Inc. Research Ethics Committee (Authorization No.: 002).
The study design comprised a multicenter, parallel, randomized control trial. The participants included 126 therapists (physiotherapists and occupational therapists), with 42 continuous samplings from each of the three Japanese medical institutions (allocation ratio: 1:1) selected for the study. The participants were assigned to one of three intervention groups. After receiving explanation regarding the research content, participants gave written consent to participate. Considering the measurement bias of the subjects, the research hypothesis was not explained.
Participants were selected on the basis of the following inclusion criteria: 1) being a permanent employee from one of the institutions, 2) being a full-time employee, and 3) willingness to participate in the research. Exclusion criteria included having disorders that may intervene with the research, such as visual, auditory, or attentional disorders. The existence of the disorders relating to the exclusion criteria was based on self-certification.
Although there was no shift from the protocol, changes were made to the designed randomization while conducting the research. As shown below, block randomization was adopted while considering the characteristic variation of the research institutions, but block randomization was not adopted in the study protocol.
Randomization and blinding
Block randomization was implemented, in which random allocation was based on affiliation (three block sizes). The sealed envelope system in central registration was used for allocation, after the principal investigator had finished selecting the research subjects. Forty-two subjects from each institution were allocated into three groups, with each group having 14 subjects. The allocation was conducted in the order of enrollment in each institution. The allocator was assigned as an educator conducting the educational program. The participant’s attribution, except for their affiliation, was masked to the allocators until the completion of the allocation.
The results of the allocation were known only by the educator of the educational program, and the participants were informed after the study had been completed. After completion of the study, participants could join an educational program other than the one to which they were assigned if they wished.
The outcome evaluator and the analyzer were masked. Analysis was undertaken by members who were not involved in allocating the assessment or in conducting the educational program. Results of the acquired outcomes were concealed from other research collaborators until the analysis was completed.
For the intervention group, a workshop of a duration of 2 hours was conducted, and lectures were given on SDM using CPGs (CPG with SDM group). The control group was divided into two: one with 2 hours of lecture on the knowledge of CPGs (CPG group) and the other with a lecture on the knowledge of SDM (SDM group).
The workshops conducted on SDM using CPGs were arranged in three ways. The subjects in the first workshop worked in pairs. The task was to verbally guide the blinded partner to a destination without touching them. The aim of this workshop was to understand the difficulty and learn the method of verbally explaining the information.
The second workshop was designed so that subjects could practice explaining whether Fruit A or Fruit B was good for health. Afterward, they studied the elements to effectively explain the benefits in line with the nine steps of SDM . The nine steps of the SDM are a technique used whereby medical practitioners and patients cooperate in decision making. The nine steps are shown in Table 1. The third workshop was on improving the walking speed of a stroke patient. In this workshop, the subjects aimed at improving the stroke patient’s walking speed, and arranged CPG information and evidence regarding the patient through the nine steps of SDM. This was conducted in a group of 5–6 members.
For the lecture on the knowledge of the CPG, the following contents were included: the definition of CPGs, process of the creation of the CPG, evaluation method of the systematic review and the risk of bias, and evaluation of the CPG approach.
The lecture on the knowledge of SDM included the definition of SDM and its difference from informed consent, the summary of the nine steps of SDM,25 and the process of decision making.
“Education, attitudes and beliefs, interests, and perceived role in evidence-based practice (EPIC scale)”  were considered the primary outcomes (Table S1). The EPIC scale is a self-administered questionnaire that evaluates the degree of self-efficacy at 11 levels. As the secondary outcome, knowledge of EBP [27-30] was examined (Table S2) using a questionnaire survey composed of 15 items on attitudes toward EBP, EBP education, and EBP-associated behaviors. A Likert scale (with options “Agree,” “Neither agree nor disagree,” and “Disagree”; and from “Strongly agree” to “Strongly disagree”) was used for answers.
The sample size was calculated on the basis of the results of the 30 participants who were primarily tested in a different pilot study, apart from this research: effect size f = 0.14, α error = 0.05, and power = 0.8. Note that the participants in the pilot study differed from the participants in this research.
Termination of the trial
The trial was terminated by the principal investigator and the research collaborator if the number of participants did not meet the prescribed number, a participant dropped out because of unavoidable circumstances, if the target number was not met, or if it was judged to be disadvantageous for the subjects. The termination of the study was to be informed in writing to the participants, reporting the facts known at the point of termination. Data were evaluated using intention-to-treat analysis.
Based on prior studies, the following were taken as confounding factors: age [10,11], sex, academic history , years of experience , certification as a physio/occupational therapist , patients’ principal disease stage in the hospital employed (acute phase, recovery phase, chronic phase) [10,11], primary disorder (orthopedic disease, developmental disorder, sports injury, spinal cord injury, post-amputation, psychiatric disorder, neuromuscular disorder, cerebrovascular disease, respiratory disease, cardiovascular disease, and other) [10,11], weekly duty hours[10,11], number of therapists at the hospital employed [10,11], number of hospital beds at the hospital employed , number of patients in a day [10,11] and participation in research activities .
Certified or specialized physiotherapist/occupational therapist is a qualification that licensed therapists can acquire after completing the prescribed training/examinations. This qualification is established by the Japanese Physical Therapy Association (JPTA).
Data on the aforementioned factors were gathered via a self-administered questionnaire, which was collected in an envelope to ensure anonymity.
A significance test of the three groups was conducted to review the intervention effect of the workshop and lecture on SDM using CPGs. For the EPIC scale, a significance test was conducted per participant, calculating the mean before and after the intervention. For the statistical analysis, since all three groups were evaluated before and after the intervention, a two-factor variance analysis (mixed model) was adopted to conduct Holm’s method in comparison with the post-hoc test. Similarly, if a significant difference in the confounding factor was recognized, the factor was considered a covariate. All statistical analyses were conducted using R (CRAN) (significance level<0.05).