Study design, setting, quality reporting, ethics
This cohort randomized feasibility higher education trial was designed as a prospective, single-center, two-arm design. This study was conducted at the BFH Department of Health, Division of Physiotherapy. Undergraduate physiotherapy students (n = 51) from the first semester were invited to participate.
At the BFH, the workload is divided into required time of attendance session (e.g. TCI, tutorials, workshops) and self-study sessions (F-SS and G-SS), whereby the workload of 1 European Credit Transfer System (ECTS) is defined as 30 learning hours. ECTS credits described the student’s workload needed to complete all learning activities (e.g. TCI, tutorials, workshops, self-study, etc.) and to achieve the specified learning objectives or competencies. The BFH guidelines recommended a workload ratio of 40% required time of attendance (e.g. TCI) to 60% of time for self-study. The workload at the BFH for the undergraduate physiotherapy degree course is < 40 hours per week.
To represent the quality of reporting of our higher education study, the CONSORT 2010 checklist was used [17]. This checklist could be used also for education studies. The ethics committee approved this study and a study registration was carried out on Registry of Efficacy and Effectiveness Studies (REES: ID: #1726.1). The sample size of n = 30 participants was based on the minimum recommended for a pilot randomized trial [18].
Participants and recruitment
Inclusion criteria for the current higher education feasibility study were young healthy physiotherapy students of the undergraduate physiotherapy degree course 2018 from the first semester (Fig. 1) of the BFH in the German speaking part of Switzerland. Exclusion criteria were: physiotherapy students of the undergraduate physiotherapy course 2018 from the first semester who did not want to take part in this study.
In Switzerland, there is a numerus clausus for the bachelor’s degree in physiotherapy. The suitability of applicants for the undergraduate physiotherapy program is examined in a two-stage professional individual suitable-test. To be admitted to the suitable-tests, candidates must have an abitur or a vocational school-leaving certificate. The best 51 candidates will be selected for the fulltime study degree course. All students fulfil the same requirements in terms of school-leaving qualifications and previous knowledge.
Recruitment of physiotherapy students of the undergraduate physiotherapy course 18 was done by means of an oral information session. After the information session, the declarations of consent were distributed. The potential study participants were given sufficient time to read the document at home in peace and quiet in order to decide for or against voluntary study participation. All participants provided written informed consent.
Randomization
As a rule, the undergraduate physiotherapy degree course regularly assigns physiotherapy students to groups A, B, C or D. This procedure is necessary to keep the group size for practical lessons small and to promote group learning. The randomized group allocation was continued before the start of the study. This randomization was not study-specific. Groups A and B and groups C and D are together in the practical sessions. The groups A and B and groups C and D were after recruitment procedure randomly assigned to either a tutor-G-SS group (n = 26) or a control group (CG; n = 25). Randomization was computer generated by an independent researcher.
Intervention
The process was based on the previous published Rogan's recommendations [11]: a total of six G-SS periods were scheduled for the G-SS group between the start of November 2018 and mid of January 2019. The duration of a G-SS period was an eight-day cycle in which a case was processed. In total six weeks were scheduled, whereby one case peer week was processed.
Cases were used for the G-SS sessions that aligned to the module contents of the undergraduate physiotherapy degree program and which were not targeted to the semester exam. The module content included areas of examination and investigation, such as basic movement (including gait), testing coordination, manual muscle strength tests, etc. Table 1 gives an overview of the contents of the clinical cases in the tutor-G-SS sessions.
The eight-day cycle of a G-SS period started from mailing the case with their tasks, the processing time and the presentation of the case was carried out as follows. On day 1, one week prior to the G-SS session, the students of the G-SS group were informed about the learning goals and received the clinical case description via email (phase one). From day 2 to 7, students could choose between an SDL or SDtL approach (phase two). With regards to SDL each group had the possibility to make an appointment with the tutor to clarify questions and processes, both on-site at the university campus and via Skype (phase two) or, alternatively, could follow the SDtL.
On day 8, the G-SS groups presented results of their work to the tutor as well as to their peers (phase three). Students carried out a reflection on their work orally (phase four). At the end of day 8, the tutor moderated an in-class plenary session and gave feedback about the presentations of the G-SS groups (phase five). The duration time of each G-SS session was 90 minutes. The tutor was a higher education lecturer from BFH with 19 years of teaching experiences.
Table 1
Overview of the G-SS clinical cases proposed in eight-day cycle procedure
G-SS period | Clinical Case | Learning objective |
1 | Thoracic massage of an elderly person after heart surgery | 1. To perform massage techniques on two different positions 2. To develop a massage checklist |
2 | Colleague with a muscle stiffness in the region of the hamstring after Squash | 1. To develop an examination protocol 2. To explain a physiological reflex model of muscle stiffness |
3 | Gait analysis of an elderly person and younger person | 1. To develop a gait analysis checklist 2. To develop an examination protocol for gait analysis |
4 | Measurement of body joint angles with goniometer and mobile-phone-based apps | 1. Explaining the differences between the neutral-zero measurement method and Apps applications 2. To develop a checklist for traditional joint angle measurement for hip and knee joint mobility. |
5 | Passive and active joint examination, translational joint examination and tests for muscle flexibility and muscle strength of the pelvis-hip-region | 1, To perform a specific examination of the hip region in a time frame of 8 minutes |
6 | Football player with knee pain with a pain area around the adductor tubercle | 1. Hypothesis-deductive approach of an examination of the lower extremity |
Control group
Students are self-reliant in F-SS and performed F-SS as planned in the traditional curriculum of the bachelor’s degree course.
Outcomes
Control of extraneous variables
To establish comparability, a randomization was carried out. Due to the numerus clausus, the school-leaving certificate, the credit points in the two-stage professional individual suitable-test and the age of the students, a homogeneous group can be assumed. These factors can be excluded as confounders. However, other confounding variables such as communication, motivation or self-regulatory skills were not assessed. Theses variables may have reduced the validity of the study results. However, the underlying assumption was that these variables were likely to be evenly distributed within both groups.
Primary outcome: feasibility
The primary outcome measure of feasibility was the fidelity of implementation which was reported as i) exposure, if the total number six G-SS sessions were covered over a period of 90 minutes, ii) students’ responsiveness to the G-SS program and iii) program differentiation to illustrate the difference between the content of the G-SS sessions and the curriculum.
Mowbray et al. [19] postulated fidelity of implementation as the extent to which the delivery of an intervention adheres to the program model originally developed and confirms that the implementation of the independent variable in outcome research occurred as planned. The Lastica and O’Donnell [20] recommendation was followed. They propose that fidelity of implementation in education intervention studies should illustrate the following aspects. What and how often was measured and how was the critical features and the degree of acceptable variation explicitly documented.
The fidelity was measured as follows: i) Exposure was measured as 1. the total number of the conducted G-SS sessions and 2. the duration of each G-SS session in minutes, ii) Students responsiveness was documented by the tutors in the attendance list after each G-SS session (Phase 3–5) and by a post-study oral group interview survey. An adequate responsiveness to the protocol was defined that every student of the G-SS group should have attended five of six G-SS session, with 83% of students consenting. iii) Program differentiation was evaluated in the course of the program conception, we examined which program-related and competing contents could be observed in the G-SS cases and the curriculum.
Secondary outcome measures:
The Kirkpatrick’s model [21] was used to evaluate students’ learning outcomes. This model has been used to evaluate training programs and for evaluation of a variety of educational setting [22, 23]. Kirkpatrick’s model is based on four levels, 1) reaction, 2) learning, 3) behavioral changes and 4) organizational performance. It is usually not possible to measure level one to level four [24]. Therefore, Level 2 has been implemented in this study. Related to learning outcomes of the intervention, this level considers whether the students acquired the intended knowledge and skills based on their participation in the intervention G-SS. Students were assessed twice per semester for written (multiple choice; MC) and practical (objective structured clinical examination; OSCE) competences. These two exams were part of the undergraduate study of physiotherapy. The OSCE consisted of eight stations. The total score for the MC exam was 94 points, the total score for the OSCE was 48 points, and the total score of each OSCE station (6 points) have been used as dependent outcome variables. The OSCE exam grade depended on their total score and the pass will be set at 60% for MC and OSCE.
Statistics
To analyze the effect of G-SS on the final grades of the written exam and OSCE (dependent variables) the number of attendances of each student on the presentation day of the G-SS was used as an independent variable.
For the secondary outcome measures, descriptive statistics were conducted and presented as means with corresponding standard deviations (SD). To guarantee that the randomization remains unbroken, an intention-to-treat analysis (ITT) was performed, where missing data were replaced by mean values of the group to which subjects were originally allocated [25]. The student’s t-test was applied to determine differences in the exam results between the two groups after the first semester. All calculations were performed using Statistical Package for Social Sciences (SPSS) version 25.0 (IBM Corp. Released 2017. IBM SPSS Statistics for Windows, Version 25.0. Armonk, NY: IBM Corp.)