A randomized controlled trial was performed with formulation of equivalence with physiotherapy students from two Colombian universities. A registry was kept of the selection of participating students, elaborated by a professor collaborating with the study, for their subsequent randomization into two groups, SP and RP, to compare the effects of both types of pedagogic intervention supported by clinical simulation. The study was approved by the ethics committee at the University of Boyacá under record number 164 of 09 June 2016, and by the subcommission on research and ethics at University of La Sabana; it was considered of minimum risk and the students were assured that the research process would not affect their semester grades; hence, the evaluations were of a formative nature.
The study included 42 fifth-semester students from two physiotherapy programmes in two Colombian universities, based on the formula for equivalency trials (11), in which size per group; normal two-tail standard deviation; acceptable difference; = standardized standard deviation of both comparison groups.
At the time of the study, the participants had taken a total of 87 credits and were actively enrolled in the participating programmes. The study excluded under-age subjects, those who had been internally or externally transferred from another academic programme in health, exchange students, and those repeating and with prior experiences in simulated practice in other assignments.
The study established a stratified sampling by blocks in each university by using the Epidat program version 3.1 and assigning participants to one of the SP and RP groups, a procedure overseen by a professor not involved with the study. A record of the process was kept (Fig. 1).
The study took into consideration the variables of sex, percentage of attendance of academic activities in SP and RP, level of bilingualism, score on the Colombian “SaberPro” state examination, and participants’ accumulated academic grade point average for their undergraduate formation.
The Objective Structured Clinical Examination for low back pain (OSCE-LBP) was applied at the start and end of the period of the SP and RP interventions. This instrument was subjected to a content validity process with external experts in the study area (12). Application of the OSCE-LBP, as an evaluation process, was conducted by professors external to the research process to minimize evaluation bias. Training of the human resources applying the OSCE-LBP was carried out through systematic training in developing the OSCE-LBP in its different stages. Additionally, inter-rater correlation coefficient values were obtained (12), and the stages in which the professors had their best performance was identified compared with the denominated gold-standard evaluator (13).
The OSCE-LBP evaluates decision-making in clinical skills while caring for a person with LBP. It has stages each with a specific weight, responding to the skills or abilities described by the researchers regarding physiotherapeutic interaction for a person with LBP, thus:
1) Physiotherapeutic examination
Anamnesis: recognizes the symptoms or antecedents including red flags and personal aspects that can guide decision making by physiotherapists in relation to LBP.
Revision by systems: recognizes physical symptoms that indicate red flags or signs of peripheral nerve involvement, or signs of LBP.
Tests and measurements: applies tests and measurements related to mobility, articular integrity, strength of the lumbo-pelvic complex, and the integrity of the peripheral nerves of the lumbo-pelvic region.
2) Physiotherapeutic evaluation
Explains to a person with LBP whether their condition is related to nociceptive LBP, neuropathic LBP or another type (central sensitization).
3) Diagnosis, prognosis and intervention plan
Proposes reachable objectives according to the characteristics of the person’s LBP.
Provides information to the patient about the treatment plan to follow according to findings obtained in the examination, bearing in mind that for mechanical LBP it is necessary to free the areas of the lumbo-pelvic region that have overloads, including muscles, ligaments and spinal disc units.
Is clear with the language used and in line with previous aspects of the interaction process.
Includes therapeutic exercise according to the person’s needs and capacity.
Includes manual techniques according to the needs.
Includes specific physiotherapy techniques according to the needs.
5) Demonstrates humanized treatment and communication skills during the process of professional interaction.
Verbal, proxemic, paralinguistic and assertive tactile communication is demonstrated according to the performance context.
The results obtained in the OSCE-LBP were established on a scale from 0.0 to 5.0 and equivalency success was determined in the SP and RP interventions obtaining a difference of 0.8 (14).
For both groups, the same pedagogic process was established to achieve the skills related to the interaction with people with LBP (described using the OSCE-LBP) in the following manner:
Learning guide process of therapeutic interaction with a person with LBP. The guide was distributed two weeks prior to conducting the SP or RP; its intention was to serve as a facilitator of the following phases of the learning process. The first part of the guide provided information and a series of independent activities for students to carry out a retrospective search about physiotherapeutic examinations for people with LBP. Some of the following parts were procedural and others aimed to seek scientific evidence related to the treatment of LBP.
Development of skills through laboratory workshops for the prescription and application of manual techniques and therapeutic exercise for the health condition studied. Each group had 10 hours of classroom sessions prior to the SP or RP, with each session seeking to develop the practical aspects of the learning guide, which in the manual techniques included therapeutic massage (caressing, effleurage, petrissage, friction) (15), and superficial techniques of myofascial release for paravertebral muscles and related to the lumbo-pelvic complex (16). The exercise techniques included central stabilization exercises (core) (17), analytic stretching and principles of postural re-education (18).
Simulation activity: for group one with standardized patient, which for this study is denominated SP, and for group two RP.
The group denominated SP received a teaching strategy based on a class session with simulated practice for decision-making in clinical skills when caring for a person with LBP. Each session lasted approximately 120 minutes, and the clinical case used for the SP sessions was subjected to face validity with experts in the area of study.
Application of the simulated practice was conducted based on experiential knowledge, considering the following sequence of its elements:
Context of the scenario: standardized for a clinical scenario of external consultation for the care of a person with LBP using physiotherapy.
Patient standardization: based on the clinical case elaborated and validated, a script was created for the actor to interpret a person with LBP. Three simulated patients were trained per institution and their participation had a ratio of one patient for every eight students.
Professor facilitator: a ratio was established of one professor for every eight students, and as in the case established, interpreted by the simulated patient, the professor started by approaching the person who was the object of care by following the characteristics of clinical reasoning.
Guiding questions: the professor asked guiding questions that sought to stir reflection regarding the clinical situation observed, asking students to imagine other clinical situations and how the intervention would vary according to this.
Concrete experience: students were permitted to interact with the simulated patient to carry out the reasoning process and thus provide care to the person.
Debriefing: a meeting was held based on reflective conversation about the learning experience in which all the actors discussed the positive aspects and the learning opportunities. This process was mediated by dialogue and active listening; at the center of it were the students, who reflected on what they had done, and described their feelings and emotions, what was opportune, and what they would improve for subsequent opportunities with a person with LBP.
The RP group, in turn, received a class session based on a “role playing” simulation strategy, structured for the same purpose established in the SP group. This session lasted approximately 120 minutes, and the learning environment was the classroom in which students assumed different roles to act out; some of them acted as people with LBP and others as physiotherapists, and in several cases they developed an interaction process with a person with LBP.
Baseline: determined the distribution of the variables (extreme values, symmetries, kurtosis, types of distribution) ‒ for qualitative variables, calculating relative frequencies (mode and erroneous data), and in all cases, evaluating the amount of data lost by each variable. The questionnaires were verified in the case of lost data. Description of the qualitative variables was conducted through absolute frequencies and percentage frequencies; the quantitative variables were described with a symmetric dispersion through medians and standard deviation. To compare the effect of the magnitude, an analysis by intention to treat was performed. Initially a difference of averages was estimated between the basal measurement and after the intervention; thereafter, a comparison was made of the interventions through a two-level hierarchical model of random intercepts and fixed coefficients (level 2: university; level 1: subject). The model is described by the following.
i: Individual, j: University, IG: Intervention Group, MB: Basal Measurement
Estimation of parameters was used with a 95% confidence level. Analyses were carried out using STATA version 14.