Implementing outcomes-based education through case-based learning and flipped classroom in the pharmacognosy teaching for pharmacy undergraduates

ERCT Criteria Breakdown

• Level 1 Criteria

  • C

    Class-level RCT

    • No randomisation occurred; groups were formed by year of enrollment, so this is not an RCT at the class level.
    • "The pharmacy undergraduates were divided into a traditional group (n=49) and a reform group (n=43) based on the different time of enrollment."
    • Relevant Quotes: 1) "The pharmacy undergraduates were divided into a traditional group (n=49) and a reform group (n=43) based on the different time of enrollment." (Abstract, p. 1) 2) "Form 2020 to 2025, a total of 92 undergraduate students majoring in pharmacy were voluntarily selected as participants for this study. Among them, a total of 49 students from 2020 to 2022 were observed as a traditional group (n=49), while 43 students from 2023 to 2025 were designated as the reform group (n=43)." (Sample, p. 3) 3) "Since the pharmacy profession at our university is conducted in small classes with about 10~20 students per year, in order to increase the sample size of students observed and verify the reproducibility of the teaching effect, we conducted a three-year traditional teaching and three-year teaching reform study." (Sample, p. 3) Detailed Analysis: Criterion C requires that the study be a Randomised Controlled Trial conducted at the class level (or stronger), with randomisation clearly described and properly implemented. The paper contains no randomisation whatsoever. Group assignment was determined entirely by the cohort's year of enrollment: the 2020-2022 cohorts formed the traditional group and the 2023-2025 cohorts formed the reform group. This is a sequential (historical-control) quasi-experimental design, not an RCT. There is no mention of any random allocation procedure, random number generator, or randomised unit at any level. The intervention is also not one-to-one tutoring, so the tutoring exception does not apply. Criterion C is not met because there was no randomisation at all; groups were assigned by enrollment year rather than by any random allocation.
  • E

    Exam-based Assessment

    • The study used an internal course final exam plus a satisfaction questionnaire, not a recognised standardised assessment.
    • "The average final exam total score (include classroom performance) of the reform group was (79.78±2.34)..."
    • Relevant Quotes: 1) "In addition to the final examination scores, classroom performance was evaluated in order to measure the quality of OBE-directed blended teaching method. And the classroom performance occupied 40% of the final score..." (The reform group, p. 4) 2) "The average final exam total score (include classroom performance) of the reform group was (79.78±2.34), and the average final exam score of the traditional group was (70.65±1.32)." (Results, p. 4) 3) "The application of the OBE-directed blended teaching method in pharmacognosy teaching was evaluated via a questionnaire survey distributed to the students." (Questionnaire, p. 4) Detailed Analysis: Criterion E requires use of a standardised, widely recognised exam-based assessment that was not designed specifically for the study. The outcome here was the course's own final examination for the pharmacognosy chapter "crude drugs derived from angiosperms," combined with a teacher-assessed classroom-performance component (40% of the score). This is an internal, course-specific assessment created and graded by the same teacher who delivered the course, not a national or state-wide standardised exam with documented validity and reliability. The remaining outcomes are a self-report satisfaction questionnaire, which is not an exam at all. No standardised testing instrument is named. Criterion E is not met because outcomes were measured by a course-internal final exam and a self-report questionnaire rather than a recognised standardised examination.
  • T

    Term Duration

    • The intervention was a 24-class-hour chapter with outcomes taken at course end, with no documented full-term tracking interval.
    • "The core content of this course was the chapter of 'crude drugs derived from angiosperms', which occupied 24 class hours."
    • Relevant Quotes: 1) "The pharmacognosy course was offered in the second semester of the third academic year... The core content of this course was the chapter of 'crude drugs derived from angiosperms', which occupied 24 class hours." (Teaching methods, p. 3) 2) "The chapter of 'crude drugs derived from angiosperms' totally occupied 24 class hours and was introduced during 8 teaching sessions, each teaching session lasted for 3 class hours." (The traditional group, p. 4) 3) "Then they were required to complete a questionnaire about their learning outcomes and overall experience after the course." (Abstract, p. 1) Detailed Analysis: Criterion T requires that outcomes be measured at least one full academic term (approximately 3-4 months) after the intervention begins. The intervention here was a single chapter delivered over 24 class hours across 8 teaching sessions (each 3 class hours). Although the course sits within the second semester of the third academic year, the intervention itself and its outcome measurement are tied to this short 24-hour chapter, with the final exam and questionnaire administered at the end of the course. The paper provides no specific calendar start and outcome dates, and there is no indication that outcomes were tracked for a full term (let alone longer) after the intervention began. The 24-class-hour scope points to a short instructional unit rather than a term-long tracking interval. Criterion T is not met because the intervention covered a single 24-class-hour chapter with outcomes measured at course end, and no full-term (or longer) tracking interval from intervention start is documented.
  • D

    Documented Control Group

    • The control group's size and conditions are documented, though demographics are pooled and no baseline scores are given.
    • "The traditional group employed traditional lecture-based learning... The teacher numbers, class hours and teaching materials of both groups in this study were the same."
    • Relevant Quotes: 1) "a total of 49 students from 2020 to 2022 were observed as a traditional group (n=49)... The sample comprised 39 males (42.40%) and 53 females (57.60%) ranging in age from 19 to 21 years old." (Sample, p. 3) 2) "The traditional group employed traditional lecture-based learning, while the reform group received an OBE-directed blended teaching method." (Abstract, p. 1) 3) "The teacher numbers, class hours and teaching materials of both groups in this study were the same." (Teaching methods, p. 3) 4) "According to the program syllabus and course teaching plan, teachers systematically presented the teaching content with the traditional lecture-based teaching method. The chapter... totally occupied 24 class hours... For each session, it was conducted in a way where the teacher explains and the students listen." (The traditional group, p. 4) 5) "The average final exam score of the traditional group was (70.65±1.32)." (Results, p. 4) Detailed Analysis: Criterion D requires that the control (traditional) group be well documented, ideally including demographics, baseline performance, and the conditions/treatment it received. The paper documents the control group's size (n=49) and the time period it spanned (2020-2022), and it clearly describes what the control group received: traditional lecture-based teaching of the same chapter, with the same teacher, class hours, and teaching materials. Its final exam outcome (70.65±1.32) and grade distribution are reported. However, demographic characteristics (gender 42.40% male / 57.60% female, age 19-21) are reported only for the combined sample of 92 students, not separately for the control group, and no baseline pre-test performance is reported for either group. Despite these gaps, the description of the control group's conditions, size, and treatment is reasonably clear, satisfying the core documentation requirement. Criterion D is met because the traditional/control group's size and conditions (same teacher, class hours, materials, lecture-based instruction) are clearly documented, even though demographics are reported only at the pooled level.

• Level 2 Criteria

  • S

    School-level RCT

    • No school-level randomisation occurred; a single institution and teacher with cohort-based assignment.
    • "a total of 49 students from 2020 to 2022 were observed as a traditional group (n=49), while 43 students from 2023 to 2025 were designated as the reform group (n=43)."
    • Relevant Quotes: 1) "Among them, a total of 49 students from 2020 to 2022 were observed as a traditional group (n=49), while 43 students from 2023 to 2025 were designated as the reform group (n=43)." (Sample, p. 3) 2) "Since the pharmacy profession at our university is conducted in small classes with about 10~20 students per year..." (Sample, p. 3) 3) "the entire course was completed by one teacher." (Teaching methods, p. 3) Detailed Analysis: Criterion S requires randomisation at the school level (the institution or unit implementing the intervention). The study involved a single university department, a single teacher, and a single course. No randomisation of any kind was performed, and certainly not at the school level. Groups were defined by enrollment cohort within one institution. Criterion S is not met because there was no school-level (or any) randomisation; the study was conducted at one institution with cohort-based group assignment.
  • I

    Independent Conduct

    • The same team designed, delivered, assessed, and analysed the intervention with no independent evaluator.
    • "Hongyan Zhu and Xiuning Huang gathered data and carried out the analyses... the entire course was completed by one teacher."
    • Relevant Quotes: 1) "the entire course was completed by one teacher." (Teaching methods, p. 3) 2) "this study integrated CBL with flipped classroom and online-offline blended learning, developing an OBE-directed blended teaching method." (Abstract, p. 1) 3) "The design and conception of this research were completed in collaboration from all authors. Hongyan Zhu and Xiuning Huang gathered data and carried out the analyses. Peng Li and Pengfei Zheng adjusted the methodologies, Qianliang Ming established research standards." (Authors' contributions, p. 7) 4) "Teachers assessed the learning effects based on the comprehension abilities and thinking development level of students during class..." (The reform group, p. 4) Detailed Analysis: Criterion I requires that the study be conducted independently of the people who designed the intervention. Here the same authors designed the OBE-directed blended teaching method, delivered it (the entire course was completed by one teacher), assessed the classroom-performance component themselves, gathered the data, and carried out the analyses. There is no external evaluation team, no third-party data collection, and no blinding. This is the textbook case of designers evaluating their own intervention, with clear potential for bias. Criterion I is not met because the authors who designed the intervention also delivered it, assessed students, collected the data, and analysed the results, with no independent or third-party evaluation.
  • Y

    Year Duration

    • Criterion T is not met and the intervention covered only a 24-class-hour chapter, far short of a year.
    • "The chapter of 'crude drugs derived from angiosperms' totally occupied 24 class hours and was introduced during 8 teaching sessions."
    • Relevant Quotes: 1) "The chapter of 'crude drugs derived from angiosperms' totally occupied 24 class hours and was introduced during 8 teaching sessions, each teaching session lasted for 3 class hours." (The traditional group, p. 4) 2) "The pharmacognosy course was offered in the second semester of the third academic year." (Teaching methods, p. 3) 3) "the sample size and duration of teaching implementation was limited." (Discussion, p. 7) Detailed Analysis: Criterion Y requires that outcomes be measured at least 75% of a full academic year (approximately 9-10 months) after the intervention begins. By the prompt's rule, if criterion T (Term Duration) is not met, criterion Y is automatically not met. T is not met here. Additionally, the intervention was a single 24-class-hour chapter with outcomes at course end, far short of a full academic year, and the authors themselves acknowledge the limited duration of implementation. Criterion Y is not met because criterion T is not met and because the intervention and follow-up span only a short 24-class-hour chapter rather than most of an academic year.
  • B

    Balanced Control Group

    • The reform group received additional out-of-class online micro-lectures and pre-class tasks (extra time/resources) not matched for the control group, so B is not met.
    • "The micro-lecture videos containing clinical cases were sent to the students through the online teaching platform (Yu Classroom or chat tool software), one week before class."
    • Relevant Quotes: 1) "The teacher numbers, class hours and teaching materials of both groups in this study were the same." (p. 3) 2) "Consistent with the traditional group, the chapter of 'crude drugs derived from angiosperms' was introduced during 8 teaching sessions, each teaching session lasted for 3 class hours." (p. 4) 3) "The traditional group employed traditional lecture-based learning, while the reform group received an OBE-directed blended teaching method, which combined Case-Based Learning with flipped classroom and online- offline blended learning." (p. 3-4) 4) "The micro-lecture videos containing clinical cases were sent to the students through the online teaching platform (Yu Classroom or chat tool software), one week before class... 3-5 clinical case-related questions were disseminated to allow students to carry out independent inquiry-based learning with guided questions." (p. 4) Detailed Analysis: Criterion B compares the time, budget, and materials given to the intervention versus the control condition. Applying the decision tree: the reform (intervention) group received additional out-of-class resources beyond the traditional group's in-class lectures, namely pre-class micro-lecture videos delivered via an online platform and pre-class inquiry-based questions, requiring additional preparation/learning time outside the classroom. The paper states the in-class hours, teacher, and teaching materials were the same, but it does not claim the control group received any matching out-of- class engagement (e.g., equivalent online materials or pre-class study tasks). The control group simply received traditional lectures with no compensating extra time or resources. Crucially, the added blended-learning resources are the very thing being tested as a separable pedagogical add-on rather than being framed as an explicit "additional resources" treatment variable with a matched business-as-usual control; the study compares a richer blended package against plain lectures without balancing the extra pre-class learning time. There is no statement that the extra time/resources were the explicit treatment variable in the sense of deliberately leaving the control at business-as-usual by design with that framing, nor any matching of the control group's time. The flipped/online component therefore introduces an unbalanced extra-time and extra-resource difference that is not offset for the control group. Criterion B is not met because the reform group received additional out-of-class online micro-lectures and pre-class inquiry tasks (extra learning time and digital resources) that were not matched by any comparable extra time or resources for the traditional control group.

• Level 3 Criteria

  • R

    Reproduced

    • No independent replication of this specific study by another team exists.
    • "this study only investigated the teaching of pharmacognosy to pharmacy undergraduates, and the sample size and duration of teaching implementation was limited."
    • Relevant Quotes: 1) "in order to increase the sample size of students observed and verify the reproducibility of the teaching effect, we conducted a three-year traditional teaching and three-year teaching reform study." (Sample, p. 3) 2) "this study only investigated the teaching of pharmacognosy to pharmacy undergraduates, and the sample size and duration of teaching implementation was limited." (Discussion, p. 7) Detailed Analysis: Criterion R requires that this specific study be independently replicated by a different research team in a different context, published in a peer-reviewed journal. The paper's own internal multi-cohort design (three years each) is not an independent replication; it is the same single team in the same institution. An internet search (Springer Nature Link, PubMed/PMC, Google Scholar) for independent replications of this specific pharmacognosy OBE-directed blended teaching study returned only the original article itself and unrelated case-based-learning / flipped-classroom studies in other disciplines and institutions (e.g., pathology, ophthalmology, nephrology, physiology, nursing). None of these reproduce this particular study by a different team, and no replication would be expected for a paper published in April 2026. Criterion R is not met because no independent replication of this specific study by a different research team in a different context could be found.
  • A

    All-subject Exams

    • Criterion E is not met and only one pharmacognosy chapter was assessed, so all-subject exams cannot be satisfied.
    • "The core content of this course was the chapter of 'crude drugs derived from angiosperms', which occupied 24 class hours."
    • Relevant Quotes: 1) "The core content of this course was the chapter of 'crude drugs derived from angiosperms', which occupied 24 class hours." (Teaching methods, p. 3) 2) "The average final exam total score (include classroom performance) of the reform group was (79.78±2.34)..." (Results, p. 4) Detailed Analysis: Criterion A requires that the study measure impact across all main subjects using standardised exam-based assessments, and it explicitly depends on criterion E: if E is not met, A is not met. Criterion E is not met here (the assessment was a course-internal final exam plus a questionnaire, not a standardised exam). Furthermore, the study assessed performance only in the single pharmacognosy chapter, with no measurement of other subjects. Criterion A is not met because criterion E is not met and because only a single pharmacognosy chapter was assessed, with no coverage of other subjects.
  • G

    Graduation Tracking

    • Criterion Y is not met and outcomes ended at course completion with no graduation tracking.
    • "Then they were required to complete a questionnaire about their learning outcomes and overall experience after the course."
    • Relevant Quotes: 1) "Then they were required to complete a questionnaire about their learning outcomes and overall experience after the course." (Abstract, p. 1) 2) "this study only investigated the teaching of pharmacognosy to pharmacy undergraduates, and the sample size and duration of teaching implementation was limited." (Discussion, p. 7) Detailed Analysis: Criterion G requires follow-up tracking of participants until graduation, and it depends on criterion Y: if Y is not met, G is not met. Criterion Y is not met here. Additionally, outcomes were measured only at the end of the 24-class-hour chapter/course, with no follow-up beyond the course and certainly no tracking through to graduation. An internet search for subsequent follow-up publications by the same authors (Hongyan Zhu, Qianliang Ming and colleagues at Army Medical University) tracking this cohort to graduation returned no such papers; no graduation-tracking follow-up exists. Criterion G is not met because criterion Y is not met and because measurement ended at course completion with no tracking to graduation, and no follow-up publication tracking the cohort to graduation was found.
  • P

    Pre-Registered

    • No pre-registration, registry ID, or protocol date is mentioned anywhere in the paper.
    • Relevant Quotes: 1) "The ethical approval for this study was waived by the Medical Ethics Committee of the Army Medical University, as the research involved an anonymous questionnaire survey..." (Declarations, p. 7) 2) "Received: 7 February 2026 / Accepted: 6 April 2026 / Published online: 15 April 2026" (p. 7) Detailed Analysis: Criterion P requires that the full study protocol be pre-registered before data collection began, with a registry reference and date. The paper contains no mention of any pre-registration, trial registry (such as ClinicalTrials.gov, ISRCTN, or a Chinese registry such as ChiCTR), or published protocol. The only governance statement is an ethics-approval waiver, which is not a pre-registration. An internet check found no associated trial-registry record for this study. Criterion P is not met because the paper provides no pre-registration statement, registry identifier, or registration date, and no registry record was found.