Study design and participants
This study was registered in University Hospital Medical Information Network center (ID: UMIN000035448), and this report depended on Consolidated Standards of Reporting Trials (CONSORT) [24].
This study was conducted with the approval of the Ever Walk Inc. Research Ethics Committee (Authorization No.: 002) . Respondents were informed about the project and they provided written consent to participate.
The design for this study was a multicenter, randomized control trial. Participants included 126 therapists (physio and occupational), with 42 continuous samplings from each of the three institutions (allocation ratio: 1:1). The setting was Japanese medical institutions. After the researchers explained the research content, participants agreed in writing. Considering the measurement bias of the subjects, the research hypothesis was not explained.
Inclusion criteria were: 1) being a permanent employee from one of the institutions, 2) those who were employed full-time, and 3) those who agreed to participate in the research. Exclusion criteria were: participants with disorders that may cause intervention in the research, such as visual, auditory, attentional disorder, etc. The existence of the disorders relating to the exclusion criteria relied on self-certification.
Although there was no declination from the protocol, changes were made to the designed randomization in conducting the research. As shown below, block randomization was adopted while taking into consideration the characteristic variation of the research institutions, whereas block randomization was not adopted in the study protocol.
Randomization and blinding
Block randomization was implemented, in which random allocation was divided by affiliation (three block sizes). The sealed envelope system in central registration was used for allocation. This was enacted during the phase when the principal investigator 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 intervenient conducting the educational program. The target’s attribution, other than their affiliation, was masked to the allocators until the allocation was completed.
The results of the allocation were known only by the intervenient of the educational program, and the targets were informed after the study was completed. It was arranged so that the contrasting allocating educational program was available if desired.
The outcome evaluator and the analyzer were masked. Analysis was undertaken by members who were not involved in the assessment allocation or conduction of the educational program. Results of the acquired outcomes were concealed to other research collaborators until analysis was completed.
Interventions
For the intervention group, 2 hours of workshop and lecture on SDM using CPGs were conducted (CPG with SDM group). The control group was divided into two groups: one with 2 hours of lecture on the knowledge of CPGs (CPG group) and one with a lecture on the knowledge of SDM (SDM group).
The workshop on SDM using CPGs was conducted in three compositions. 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 to learn the method in explaining the information verbally.
The second workshop was to practice explaining whether Fruit A or Fruit B was good for health. Afterward, subjects studied the elements to effectively explain the benefits along the nine-steps of SDM [25]. The nine-steps of SDM is a technique used whereby medical practitioners and patients cooperate in decision-making. It is constructed from the following steps: 1. Disclosure that a decision needs to be made, 2. Formulation of the equality of partners, 3. Presentation of treatment options, 4. Informing on the benefits and risks of the options, 5. Investigation of the patients’ understanding and expectations, 6. Reaching a shared decision, and 9. Arrangement of follow-ups [25].
The third workshop assumed a case in improving the walking speed of a stroke patient. In this workshop, the subjects actually arranged a CPG and evidence according to the patients’ goal 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 the evaluation of the CPG approach in evaluating the CPG.
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.
Outcomes
Education, attitudes and beliefs, and interest and perceived role in evidence-based practice (EPIC scale) [26] was used for the primary outcomes (S1 Table). The EPIC scale is a self-administered questionnaire that evaluates the degree of self-efficacy at 11 levels. For the secondary outcome, an examination of the knowledge of EBP [27-30] was conducted (Table S2). The knowledge of the EBP was evaluated using a questionnaire survey composed of 15 items on attitudes toward EBP, EBP education, and EBP-associated behaviors. A Likert scale (answers of three selections: “Agree,” “Neither agree nor disagree,” and “Disagree” and five selections: from “Strongly agree” to “Strongly disagree”) was used for answers.
Sample size
The calculation of the sample size was performed based on the results of the 30 participants who were primarily tested: effect size f=0.14, α error=0.05, and power=0.8. G power was used to calculate the sample size.
Termination of the trial
The trial was terminated by the judgement of the principal investigator and the research collaborator if: the number of participants did not meet the prescribed number, a participant dropped out due to an unintentional reason, failure to meet the target number, or if it was judged to be disadvantageous for the subjects. The termination of the study was to be noted in writing to the participants, reporting the facts known at the point of termination. Analysis was conducted using intention to treat analysis.
Confounders
From the preceding study, the following were recruited as confounding factors: age [10,11], sex, academic history [31] , years of experience [10], acquirement of certified physio/occupational therapist [12], principal disease stage of the hospital employed (acute phase, recovery phase, chronic phase) [10,11], mainly responsible 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 [32], number of responsible patients in a day [10,11], and participation in research activities[12]. The factors above were inquired through a self-administered questionnaire. An envelope was used to collect the questionnaire to anonymize the individuals.
Statistical analysis
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 statistical analysis, since all three groups were evaluated before and after the intervention, two-factor variance analysis (mixed model) was adopted to conduct Holm’s method in comparison to the post-hoc test. Likewise, 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).