Effect of Education on Shared Decision-making using Clinical Practice Guidelines: A Randomized Controlled trial.

Background: To investigate the inuence of the evidence–practice gap on physiotherapists and occupational therapists through shared decision making (SDM) using clinical practice guidelines (CPGs). Methods: The study was designed as a blocked, randomized controlled multicenter trial. Participants included 126 therapists with 42 continuous samplings from three institutions. Being a permanent employee from any of these institutions was a necessary inclusion criterion. However, participants with disorders (visual, auditory, attentional disorder) were excluded. An allocator was assigned to mask the participation’s attribution until the allocation was completed. The evaluator and analyzer were also masked. For the intervention group, a workshop was conducted on SDM using CPGs. Lecture on the knowledge of CPGs (CPG group) and lecture on the knowledge of SDM (SDM group) were the control groups. The primary outcomes were “education, attitudes and beliefs, and interest and perceived role in evidence-based practice (EPIC scale).” The secondary outcome included evidence-based practice (EBP) knowledge. To review the intervention effect of education on SDM using CPGs, two-factor variance analysis (mixed model) was adopted to conduct Holm’s method. Results: In each group, 42 participants were randomized and analyzed. The EPIC scale showed signicant difference between the CPG with SDM and CPG groups (CPG with SDM group [mean ± standard deviation, pre/post] (cid:0) 2.4±0.9/4.4±1.7; CPG group (cid:0) 3.0±1.5/3.5±2.0; SDM group (cid:0) 2.6±1.2/ 3.3±1.8 (cid:0) . The question on EBP “I learned the foundations for EBP as a part of my academic preparation” showed signicant differences between the CPG with SDM and CPG groups (cid:0) CPG with SDM group (cid:0) 1.8±0.8/2.2±1.0; CPG group (cid:0) 2.3±1.1/ 2.0±1.0 (cid:0) . Conclusion: SDM the point of termination.

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 de nition 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 de nition 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, interests, and perceived role in evidence-based practice (EPIC scale)" [26] were considered the primary outcomes (Table S1). The EPIC scale is a self-administered questionnaire that evaluates the degree of self-e cacy at 11 levels. As the secondary outcome, knowledge of EBP [27][28][29][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.

Sample size
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.
Certi ed or specialized physiotherapist/occupational therapist is a quali cation that licensed therapists can acquire after completing the prescribed training/examinations. This quali cation 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.

Statistical analysis
A signi cance 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 signi cance 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 signi cant difference in the confounding factor was recognized, the factor was considered a covariate. All statistical analyses were conducted using R (CRAN) (signi cance level<0.05).

Results
The owchart for participant selection is shown in Figure 1. Forty-two participants were randomized to each group. The application period for the participants was from May 1, 2017, to April 30, 2018. There were no dropouts or untraceable participants in any group.
Patient attribution is shown in Table 2. There were no signi cant differences between the groups.
The result of the analysis showed that, for the question items "3. Effectively conduct an online literature search" and "Ask about needs, values, and treatment preferences," "9. Ask about needs, values, and treatment preferences," and "10. Decide on a course of action," on the EPIC scale, there were signi cant differences between the CPG with SDM group, SDM group, and CPG group.
In the questionnaire on EBP, for the question item "11. I learned the foundations for EBP as a part of my academic preparation," there were signi cant differences recognized between the CPG with SDM group and CPG group (CPG with SDM group [mean±standard deviation; pre/post]: 1.8±0.8/2.2±1.0; CPG group: 2.3±1.1/2.0±1.0) ( Table 4).

Discussion
It became evident that CPG/SDM education through a workshop style targeting physiotherapists and occupational therapists increased the reports of self-e ciency in EBP as compared with a lecture style of CPG/SDM education. This indicates a new principle for increasing education on the perceptions of self-e cacy in EBP. While conducting SDM education using CPGs, there are three reasons to improve the con dence in EBP: rst, the perspective on "the demand of SDM for CPG," which is stated in the de nition of CPG as the signi cance of education in communication using SDM; second, the perspective on "the Page 6/16 The perspective on "the demand of CPG for SDM" relates to the knowledge of the standard intervention method needed to conduct SDM. While applying SDM, the knowledge of the applicable treatments and standard evidence for rehabilitation is indispensable in the following steps: "Presentation of treatment options" and "Informing on the bene ts and risks of the options." In contrast, the awareness of Japanese therapists on CPGs and the evidence was reported to be lower than that of therapists in foreign countries. Fujimoto et al. [27] researched the awareness of EBP while targeting Japanese physiotherapists. Although 54.9% perceived the signi cance of CPGs, the usage was below 30% [27], which is less than the 61% usage in foreign countries [28] .
One reason for this could be the lack of therapist education on the usage of CPGs in Japan [27]. Particularly, perspectives on applicable situations are lacking in practical education in Japan [34]. In other words, it is essential to adopt CPGs as an information source. As seen in this study, combining education on CPGs with SDM emphasizes the need for CPG perspective in SDM. This, along with the reason stated above, increased the degree of reliability of EBP.
Third, by simultaneously conducting education on CPG and SDM, therapists understood the uncertainty of rehabilitation interventions and the presence of SDM in decision making.
In Japan, the establishment of evidence is still developing in the eld of rehabilitation. In an earlier study that assessed the quality of practice guidelines in physical therapy released by the Japanese Physical Therapy Association using AGREE II Appraisal of Guidelines for Research & Evaluation , the scores were low [35]. As stated above in the item on the rigorousness of the guideline production process, such as "Is organized search method used to search the evidence," the median was 3.0 on a 7-point Likert scale, suggesting the need for modi cation [35]. Again, the development of a database that considers diseases, such as cerebrovascular disease, femoral neck fracture, and spinal cord injury, is under process to establish evidence on the effectiveness of rehabilitation [36]. However, its effectiveness was not satisfactorily veri ed because of the lack of participating facilities, and further improvements are recommended for the quality of data [36].
Rehabilitation elds are known for the uncertainty of the treatments due to the high individuality of the goal caused by various patient-related factors, such as physical status, ability of daily living, premorbid life background, and home environment. For instance, it is challenging to execute a systematic rehabilitation program for senior citizens, who are the main target of rehabilitation, because the patients' physical and cognitive functions are disproportionate [37,38]. In a eld of high uncertainty with many options for treatment, several therapists nd it di cult to present evidence to patients [39] . Currently, incorporating education on evidence for pre/postgraduate training and communication training on the method of adopting evidence to patients are yet to be completed [34] .
Above all, conducting CPG education with SDM education may convince therapists that SDM is suitable as a communication tool for decision making through their experiences in communicating and adopting to patients in actual practice. In fact, in studies targeting foreign physiotherapists, close to half favored SDM for their decision making approach in the rehabilitation eld, with 28.9% implementing SDM in their clinical practices [40]. SDM is reported to be useful in involving patients in decision making by increasing patients' self-e cacy [41,42], enhancing their understanding of the disease and its treatments [43,44], and increasing satisfaction [45,46]. For this reason, SDM is highly applicable as a communication tool in the rehabilitation eld. In a study that researched the determination of a treatment plan targeting Japanese primary care physicians, 14.6% practiced SDM. This signi es the gradual acceptance of SDM as a decision-making method in Japan [47].
Similarly, knowledge of evidence along with training on communication techniques by instructing about the speci c steps using SDM increased therapists' con dence toward EBP, as they were convinced that the utilization of evidence is applicable in clinical situations.
This study has four limitations. First, since the "awareness" of EBP was adopted as a main outcome, it is di cult to determine whether it is practiced in actual clinical situations. As the EPIC scale was used as an index of the self-e cacy of EBP, since it is a self-administered outcome, it is unknown whether the behavior changed regarding EBP in the clinical situation or improved The authors declare that they have no competing interests.

Funding
This study was supported by grants from Japan Primary Care Association. The funding o ces had no direct or indirect involvement in the study writeup and analysis; the o ces were only involved in budgeting and budget evaluation.
Authors' Contributions SF contributed to conceptualization, methodology, design and development of the intervention, data collection, data interpretation, and drafting and revision of the manuscript, and was a major contributor to writing the manuscript. TO contributed to the development of the intervention, data collection, and revision of the manuscript. KK contributed to the statistical analyses, drafting, and revising the manuscript. TN critically revised the manuscript for important intellectual context. All authors read and approved the nal manuscript.