Development and evaluation of an evidence-based medicine module in the undergraduate medical curriculum

DOI: https://doi.org/10.21203/rs.3.rs-22869/v1

Abstract

Background:

Evidence-based medicine (EBM) is a core competence in both undergraduate and postgraduate medical curricula. However, its integration into curricula varies widely. Our study will help medical colleges develop, implement and evaluate their EBM courses. We assessed the effectiveness of workshops in improving critical appraisal skills among medical students.

Methods

A before-and-after study design without a control group was used. A 5-week short EBM module including lectures, workshops, and online search sessions was conducted with 52 fourth-year medical students during their primary healthcare course at the College of Medicine, Princess Nourah bint Abdulrahman University. Statistical analysis was performed using SPSS statistical software (version 20, SPSS Inc., Chicago, US). Parametric tests as well as Student’s paired t-test for pre- and post-test comparisons were used.

Results

Forty-nine (49) participants completed the pre- and post-training Fresno tests, and 44.9% of the participants had a GPA of 4.0 or higher. The mean Fresno test score increased from 45.63 (SD 21.89) on the pre-test to 64.49 (SD 33.31) on the post-test, with significant improvements in the following items: Searching strategies, Relevance, Internal validity, Magnitude & significance of results, Statistical values of diagnosis studies (sensitivity, specificity, and LR), Statistical values of therapy studies (ARR, RRR, and NNT), and Best study design for diagnosis and prognosis (P < 0.05).

Conclusion

This study supports that short course in EBM that is incorporated into the undergraduate curriculum especially in the clinical years might be effective in improving medical students’ knowledge and skills in EBM. However, prospective studies are necessary to assess the long-term impact of these interventions and ultimately their effectiveness for clinical decision making.

Background

Evidence-based medicine (EBM) was first introduced in early 1990 and was defined by Sacket et al. [1] as “the conscientious, explicit, and judicious use of current best evidence in making decisions about the care of individual patients.” The principles of EBM include asking the appropriate clinical question, searching related and relevant clinical data, appraising the data, applying the data to the appropriate clinical scenario, and finally evaluating the data [2]. This concept has been adopted by many allied healthcare professionals, and the Sicily statement of evidence-based practice proposed the change to evidence-based practice (EBP) instead of EBM [3]. Thus, EBM is considered one of the important revolutions in healthcare education and practice, and it has become a core competence in both undergraduate and postgraduate medical curricula [4, 5]. However, there are no clear recommendations on when to initiate teaching on EBM, as indicated by a series of studies that showed no difference in EBP competence between undergraduates and postgraduate medical students [6].

Thus, the integration of EBM into the undergraduate curriculum varies from medical school to another [7]. In addition, there is debate about the most effective training method for EBM for undergraduate students. Different types of teaching methods, such as flipped classrooms, journal clubs, seminars and morning reports, have been reported in the literature [810]. Furthermore, some studies have proposed that EBM may be offered as online or in a blended learning format [11, 12]. Moreover, a number of studies have recommended the shift to more student-centred and problem-based learning [13]. These educational activities have shown an impact on EBP knowledge, attitudes and skills and, eventually, might affect patient outcomes and the quality of health care [14]. However, the degree of impact on healthcare practice and sustainability due to the changes after these activities have been implemented is unclear [15].

Assessment and evaluation of EBP competence is a complex task to achieve through the use of a single method [16]. A few validated tools exist to assess competence, and they have been widely used. Among the most common tools are the Berlin and Fresno tests [17, 18], but similar validated tools to determine the extent to which attitudes change after an educational intervention are lacking. Moreover, studies that rely on student self-reports as measurement tools have shown that self-reports are not a reliable method for measuring long-term changes in the attitudes or behaviour of medical students [19, 20].

This study needed to be published because there are few published studies on EBM teaching in developing countries [21]. In addition, one local study on medical students from different colleges in the Kingdom of Saudi Arabia reported low levels of knowledge and attitudes towards EBM, which calls for a well‑structured incorporation of EBM as a major competence into the undergraduate curriculum [22]. Moreover, it has been suggested that the emphasis should not be on teaching the science of EBM but rather on its practical application to patient care and that the curriculum would be better named the Knowledge Translation Curriculum [23].

The College of Medicine at Princess Nourah bint Abdulrahman University (PNU) is a newly established medical college in the Kingdom of Saudi Arabia. Its curriculum can be described as a hybrid, problem-based curriculum that takes over 5 years for students to complete. The EBM module was first introduced as part of the primary health care course among the first cohort in 2015/16, and it continues to be part of the curriculum. To fulfil the college mission, efforts have been made to improve the curriculum in general and the EBM module in particular since EBM is one of the core programme competencies. Thus, for the past four years, multiple changes in the module content and assessment methods have taken place. This article describes an initiative to develop, implement and evaluate a short EBM module for Year 4 students of the MBBS programme. In addition, the article assesses the effectiveness of a hands-on workshop on EBM using a validated tool (the Fresno test) and assesses students’ overall performance using an authentic assignment.

Methods

Context

The EBM module was included in the fourth year within the primary healthcare course, which is taken after the medical research/epidemiology course that is offered in the third year. The placement of the module was deliberate to ensure that students would have a foundation in study design, research methodology and basic biostatistics prior to taking the EBM module. The objectives of the module included the following: to develop relevant knowledge and skills in framing questions in the PICO format, conducting database searches and critically appraising findings and be able to demonstrate these steps of EBM. That is, by the end of the module, the students were expected to be able formulate a PICO question based on a clinical scenario, search online for the relevant studies, critically appraise the findings for their validity and appropriateness and discuss their applicability. These skills were assessed with the use of a graded rubric for both written (report) and verbal (presentation) assignments. The module was taught by faculty members who specialized in family medicine (2), community medicine (1) and public health. (1) All faculty were trained in EBM teaching either in the Centre for Evidence-Based Medicine at the University of Oxford or at McMaster University and had been trainers at the National & Gulf Centre for Evidence-Based Health Practice in Riyadh, Saudi Arabia.

The content of the module is shown in Table 1. In week 1, the module included lectures delivered on one to three mornings during the week. Fifty- to 100-minute lectures were followed by 150-minute small-group workshops during week 2; in the small-group workshops, 50–100 minutes were used for online database searching, and 75–150 minutes were spent on critical appraisal skills with therapy and diagnosis papers that were chosen by the trainer. In weeks 3 and 4, students were assigned to small groups supervised by faculty to work on their own assignments. In week 5, each student’s was assessed on her skills in presenting an EBM topic and submitted a detailed report that was standardized and formatted to cover the EBM steps (Ask, Acquire, Appraise, Apply and Assess). Concurrent validity was tested with the Fresno test. In addition, students were asked to submit the full-text article used in the assignment as well as the critical appraisal sheet. In this study, we did not test the validity, inter-rater agreement, internal consistency, acceptability and feasibility due to the small sample size. However, we collected the relevant data for consideration for publication

Table 1

Content of the EBM module

Topic

Learning Objectives

Teaching Method/Duration

EBM I: Introduction

• Define EBM

• List the EBM steps

• Formulate answerable clinical questions (PICO)

Lecture/100 min

EBM II: Literature search

• Translate PICO questions into a search strategy

• Demonstrate the EBM resources search

Interactive tutorial/50–100 min

Critical Appraisal Skills I

• Understand the concepts of critical appraisal (diagnosis and therapy)

Lecture/50 min

Critical Appraisal Skills II

Lecture/50 min

Critical Appraisal Skills III

Lecture/50 min

EBM Workshop I

• Critically appraise an article on therapy (RCT–SR&MA) using a McMaster worksheet

Hands-on workshop/150 min

EBM Workshop II

• Critically appraise an article on diagnosis using a McMaster worksheet

Hands-on workshop/75 min

EBM Assignment

• Demonstrate EBM steps for clinical questions selected by the student under faculty supervision

Presentation and report

Study design

No control group was included in this before-and-after study, as the participants were the first cohort who received the educational intervention.

Sample size

All fourth-year medical students were included (n = 52).

Sampling technique

Not applicable

Data collection methods, instruments used, measurements

A before-and-after study design was used. Students were evaluated using a validated Fresno test. A 5-week short EBM module including lectures, workshops, and online search sessions was conducted with fifty-two fourth-year medical students during their primary healthcare course at the College of Medicine, PNU, from the first of September until mid-December 2016. The pre-test was administered in the second week of the module after the theoretical part and immediately before the workshops. The post-test was administered during week 3 after the teaching of the module, including the workshops, was completed. Each student had a code number that replaced her name on the pre- and post-test papers to ensure that the students’ identities were protected. Moreover, to avoid inter-rater bias, an experienced faculty member in EBM was responsible for grading both the pre- and post-test papers. In weeks 4 and 5, students were asked to work on their EBM assignment under faculty supervision. At the end of the module, one faculty member was responsible for marking the EBM reports using a standardized format. Two other faculty members were invited to assess students’ EBM presentation skills using a standardized rubric.

Statistical analysis

Statistical analysis was performed using SPSS statistical software (version 20, SPSS Inc., Chicago, US). The effectiveness of the EBM workshop was assessed based on the differences in the total and subtotal pre- and post-training Fresno test scores, which were the primary outcome. Parametric tests were used to test the study hypotheses, such as the mean, standard deviation, and confidence interval (CI %). Comparison of the total Fresno pre- and post-test scores was conducted using Student’s paired t-test to determine whether there was a statistically significant difference in the students’ performance before and after the intervention. A P value .05 was considered significant.

Reliability of the Fresno test

The Fresno test is an objective, comprehensive tool that consists of 12 items that cover basic knowledge and skills in EBM [18]. The test includes two clinical scenarios with open-ended questions. Participants are required to complete the four key steps of the EBP process to adequately answer the open-ended questions related to the clinical scenarios. In addition, two questions are related to statistics for observational and experimental studies. We omitted some items in the calculation section because 98% of students left them blank on the pre-test. Therefore, the total Fresno score in this study ranged from 0–204.

Cronbach’s alpha and the item-total correlation were used to determine internal reliability. Cronbach’s alpha was used as the index of internal consistency of the test, with an acceptable range from .7 to .95. The item-total correlation was used to determine the reliability of each scale, with an acceptable value of 0.2 or higher. The lowest item-total correlation was .263, which is above the acceptable value (item 9). As shown in Table (2), Cronbach’s alpha was .775, which is statistically acceptable.

Table 2

Reliability results and item-total statistics

 

Corrected Item-Total Correlation

Cronbach's Alpha If Item Deleted

Item 1A

.415

.763

Item 1B

.401

.763

Item 2

.455

.760

Item 3

.443

.757

Item 4

.523

.747

Item 5

.483

.754

Item 6

.497

.755

Item 7

.556

.745

Item 8

.500

.752

Item 9

.263

.775

Item 10

.268

.774

Item 11

.369

.768

Item 12

.351

.768

Total items

 

.775

Results

After data cleaning, forty-nine (49) participants who completed the pre- and post-Fresno tests were included in the analysis. Twenty-two (44.9%) of the participants had a GPA of 4.0 or higher, 15 (30.6%) had a GPA ranging between 3.05 and 3.58, and 24.5% of the participants had a GPA in the range of 3.59 to 4.12 out of 5. Overall, students’ performance improved on the post-test; the improvement was statistically significant even for those with a low GPA, as shown in Figs. 1 and 2.

The students’ scores were classified into 4 categories: poor (0–50), average (51–101), good (102–152) and excellent (153–204). Regarding student performance on the pre-test, the majority of students had a poor score of 67.3%, 28.5% had an average score, and only 4% had a good score. There was a statistically significant difference between the pre- and post-tests; on the post-test, the majority had an average score (63.3%), followed by 26.5% who had a poor score, 8% who had a good score and 2% who had an excellent score (chi-square = 16.406, DF = 2, P value = 0.000).

A comparison using a paired t-test shows that the mean Fresno test score increased from 45.63 (SD 21.89) on the pre-test to 64.49 (SD 33.31) on the post-test, with statistically significant improvements seen in the following items: Searching strategies, Relevance, Internal validity, Magnitude & significance of results, Statistical values of diagnosis studies (sensitivity, specificity, and LR), Statistical values of therapy studies (ARR, RRR, and NNT), Best study design for diagnosis and Best study design for prognosis (P < 0.05) (as shown in Table 3). These results indicate the effectiveness of hands-on workshops in improving technical skills related to EBM, such as calculations and search strategies.

Table 3

Fresno test score (n = 49) based on the results of the paired samples t-test

Item #

Area of knowledge

Test

Mean

(95% CI)

SD

T value

P value

1 A & B

Formulation of clinical questions (PICO format)

Pre-test

7.28

(6.58–7.980)

2.44

1.196

.24(ns)

Post-test

7.84

(6.84–8.84)

3.49

2

Sources of evidence

Pre-test

3.51

(2.844.18)

2.33

1.741

.08(ns)

Post-test

4.16

(3.344.99)

2.88

3

Searching strategies

Pre-test

4.57

(3.335.81)

4.32

2.355

.02*

Post-test

6.37

(4.668.08)

5.95

4

Study design

Pre-test

10.65

(9.1912.11)

5.09

1.271

.21(ns)

Post-test

11.57

(9.9413.20)

5.68

5

Relevance

Pre-test

1.63

(.84-2.43)

2.77

3.577

.001**

Post-test

3.57

(2.474.67)

3.82

6

Internal validity

Pre-test

1.98

(.58-3.38)

4.86

2.291

.027*

Post-test

4.16

(1.81–6.52)

7.64

7

Magnitude & significance of results

Pre-test

2.94

(1.16–4.72)

6.21

3.326

.002**

Post-test

5.94

(4.17–7.71)

6.17

8

Statistical values of diagnosis studies (sensitivity, specificity, and LR)

Pre-test

.49

(-.11-1.09)

2.10

7.247

.000**

Post-test

4.41

(3.38–5.44)

3.58

9

Statistical values of therapy studies (ARR, RRR, and NNT)

Pre-test

1.47

(.33-.61)

3.97

2.424

.019*

Post-test

3.35

(2.08–4.62)

4.42

10

Confidence interval estimation

Pre-test

.33

(.01-.64)

1.11

1.950

.058(ns)

Post-test

.74

(.26-1.23)

1.58

11

Best study design for diagnosis

Pre-test

1.96

(1.38–2.54)

2.02

3.947

.000**

Post-test

3.34

(2.89–3.81)

1.49

12

Best study design for prognosis

Pre-test

1.55

(.99-2.12)

1.97

2.549

.01*

Post-test

2.51

(1.91–3.11)

1.96

NB: * Significant at 0.05, ** Significant at 0.01, ns = Not significant

Our secondary outcome was students’ overall performance on the EBM assignment. This outcome was assessed with two assessment methods, an oral presentation graded from 0–50% and an EBM report graded from 0–50%, as shown in Fig. 3. Overall, students performed well on both assignments, with mean scores of 42.5 and 47.7 for the presentation and report, respectively.

Discussion

The Fresno test is a reliable and valid tool for the assessment of knowledge and skills on the four key EBP steps: asking focused questions, searching for relevant resources, and critically appraising validity and appropriateness. The test was a good tool to assess changes due to the educational intervention, i.e., an EBM workshop, in this study. However, the item difficulty was high to very high. Despite an overall improvement on the post-test, few students were able to obtain good total scores. This might be because students took the test in a relaxed environment and did not prepare as if it were a real exam. Moreover, we expect that total scores would have been lower if we had retained the items related to advanced calculations for diagnosis and therapy. Our study findings suggest that it would be better to conduct the intervention with more experienced groups, such as medical residents, similar to the original cohort [18]. Notably, answering open-ended questions is challenging for undergraduate students, especially if the questions have multiple parts, such as items 2 and 3. Therefore, in our case, the majority of students were able to answer only the first part of the questions. However, we are not sure if the students unintentionally did not provide answers to the remaining parts of the questions or intentionally left them blank due to a lack of knowledge. We might adapt the Fresno test in future studies but with a few modifications to the items to ensure that students answer all items requested. In contrast, similar studies have found that the Fresno test is a good tool for assessing competence among EBM novices [24, 25].

This study shows that a short EBM module can change knowledge and skills among undergraduate medical students. This result is consistent with a systemic review that showed that learners’ competence in EBM increased post-intervention across all studies irrespective of the type of educational method [26]. Our curriculum included a mixture of three methods: didactic (lectures), workshop-based and self-directed learning with measurable outcomes. Overall, students were positive about their learning experiences in the workshops. Although workshops are considered a common teaching method in EBM, few published studies have assessed their effectiveness among undergraduate students [27, 28]. In this study, workshops were an effective method to improve EBM technical skills, such as searching the literature, critiquing the validity of findings, and performing statistical calculations, such as sensitivity, specificity, and NNT calculations. The workshop required active participation, and we provided the students with the materials (scenarios, articles and critical appraisal worksheet) prior to the workshop. Additionally, the study was conducted with a small group that guided by a facilitator with a facilitator-student ratio of 1 to 12. Our objectives were focused on developing critical appraisal skills with particular attention to results interpretation and statistical concepts. These same objectivise were defined in a similar study performed on healthcare professionals that showed that the more active the participation, the more knowledge trainees gained [29].

One might question the sustainability and extent to which courses can actually be responsible for learners’ improved EBM practice after they finish the course. There is no clear evidence on the best timing and duration of EBM teaching. One study recommended the inclusion of EBM courses at least twice during medical studies, with greater intensity shortly before graduation [30]. Other studies recommended a longitudinal EBM course [31] or a course offered in the clinical years [32]. However, the current study cannot answer the question of when EBM courses should be offered. Such a limitation is to be expected with a before-and-after design, which supports weaker inferences than a randomized trial. Future studies with randomization and a sufficiently long follow-up after intervention might provide better insight into this issue. A strength of our study is its development of a new assessment method for EBM competence, i.e., the EBM assignment. However, such tools require further validation, which will be performed in an upcoming study.

Conclusion

EBM is an important competence for undergraduates. This study supports that short course in EBM that is incorporated into the undergraduate curriculum especially in the clinical years might be effective in improving medical students’ knowledge and skills in EBM. Furthermore, this study add to the body of evidence which suggests multiple teaching and learning strategies that can improve students’ short-term EBM knowledge and skills. However, rigorous studies are necessary to assess the long-term impact of these interventions and ultimately their effectiveness for clinical decision making.

Abbreviations

EBM

evidence-based medicine

EBP

evidence-based practice

PNU

Princess Nourah University

Declarations

Ethics approval and consent to participate

The study protocol was approved by the Institutional Review Board at PNU, Riyadh, Kingdom of Saudi Arabia (KSA) (IRB-PNU:20-0082). Verbal consent was taken from students before they have taken the Fresno-test. To assure confidentiality each student was given a code number instead of her name or student number. Other data such as students’ GPA , EBM assignment marks was entered by the author. Statistical analysis was done independently by the research services centre.

Consent for publication:

In accordance with regulations of Institutional Review Board at Princess Nourah bint Abdulrahman University.

Availability of data and materials

All data used in the study are available for interested researchers upon request from corresponding author after approval from the Institutional Review Board at PNU (contact [email protected]).

Competing interests

The author declares no competing interests

Funding

The study received no funding from any source

Authors' contributions

AA, performed the study design, interpretation of data, manuscript preparation

Data entry and analysis was done with the help of research services center

Acknowledgements

I cannot express enough thanks to my colleagues for their active participation in teaching and evaluating the EBM module and for their continued support and feedback: Dr. Amal Fayed, Associate Professor of Public Health, College of Medicine at PNU; Dr. Amani Almuallem, Consultant Family Medicine at King Abdulaziz Medical City; and Dr. Samia Alhabib, Consultant Community Medicine at King Abdullah bin Abdulaziz University Hospital.

This work was inspired by my attendance of the EBCP workshop at McMaster University, the leading EBM centre. Attendance of this conference was a great opportunity to further develop my knowledge and skills. This project could not have been completed without the support of the trainers, Dr. Denise Campbell-Scherer, Professor at Department of Family Medicine at University of Alberta, Canada, and Mr. Brad Dishan, Medical Librarian at St. Joseph’s Health Care London, Ontario Canada.

Finally, to my caring, loving, and supportive husband, I express my gratitude for your encouragement.

Authors' information

The author is currently working as assistant professor and consultant family medicine

College of medicine, PNU

She had previously appointed as vice dean of quality and development and MBBS program chair at the same institute.

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