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End point
SECONDARY
The primary endpoints included changes in MBG, SDBG, MAGE, PPGE, LAGE, MODD, TIR, breakfast AUCpp, lunch AUCpp, and dinner AUCpp readings during the screening period, lead-in period, and after 12 weeks of treatment.The secondary endpoints were changes in HbA1c, FBG, 1h-PBG, 2h-PBG, fasting blood lipids, postprandial bl...
PMC10653384
Statistical method
All statistical analyses were performed using SPSS 25.0. For normally-distributed numerical variables, one-way analysis of variance (ANOVA) was used to compare differences between groups, and paired Student’s t-tests were used before and after treatment to assess differences in intra-group outcome measures. For non-nor...
PMC10653384
Results
PMC10653384
Baseline patient characteristics
T2DM, TG, diabetes
INS, DIABETES
We included 30 patients with T2DM for whom blood glucose levels could not be successfully controlled. Of them, 10 were assigned to each of the INS, INS+Met, and INS+SZ-A groups. No significant differences were observed in the general characteristics (such as age, sex ratio, weight, BMI, waist circumference, waist-to-hi...
PMC10653384
General conditions at baseline and after the 12-week treatment
TG
Compared those during screening period, HbA1c and FBG in the three groups were significantly improved after 12 weeks of treatment (P<0.05), but weight changes were not statistically significant (P>0.05). Compared with those during the lead-in period, the insulin doses in the Ins+Met and Ins+SZ-A groups decreased after ...
PMC10653384
Fasting and postprandial blood glucose and lipid levels after 12 weeks of treatment
TG
BLOOD
After 12 weeks of treatment, FBG and 1h-PBG levels were lower in the Ins+Met and Ins+SZ-A groups than in the Ins group (P<0.05;Fasting and Postprandial Blood Glucose and Lipid Levels After 12 Weeks of Treatment After 12 weeks of treatment, the fasting TG, 1-hour postprandial TG, 2-hour postprandial TG, and TG AUC indic...
PMC10653384
Continuous glucose monitoring results
No statistically significant differences were noted in terms of CGM indicators such as MBG, SDBG, LAGE, PPGE, MAGE, MODD, TIR, breakfast AUCpp, lunch AUCpp, and dinner AUCpp among the three groups during the screening and lead-in period (P>0.05). Compared to the screening period, the MBG, SDBG, LAGE, PPGE, MAGE, MODD, ...
PMC10653384
Adverse reactions
diarrhea, hypoglycemic reactions
ADVERSE REACTIONS, EVENTS, HYPOGLYCEMIC REACTIONS
After 12 weeks of treatment, there were no statistically significant changes in ALT, AST, Cr, and UA in any of the groups (P>0.05). The three treatment regimens did not show any severe hypoglycemic reactions during any of the study phases. There were no significant differences in the hypoglycemic responses of the three...
PMC10653384
Discussion
flatulence, diarrhea, abdominal pain, TIR, hypoglycemia, hyperglycemia, reduced fasting blood lipids, ’ blood glucose, abdominal distension, postprandial hyperglycemia, T2DM, diabetes
HYPERLIPIDEMIA, ASYMPTOMATIC HYPOGLYCEMIA, HYPOGLYCEMIA, HYPERGLYCEMIA, DIABETIC COMPLICATIONS, DIABETES
It is important to reach the target levels for blood glucose and HbA1c when treating patients with T2DM. Good control over blood glucose fluctuations is also important. Patients with diabetes who have similar HbA1c levels may have different blood glucose stabilities, and large blood glucose fluctuations may be associat...
PMC10653384
Data availability statement
The original contributions presented in the study are included in the article/supplementary material. Further inquiries can be directed to the corresponding author.
PMC10653384
Ethics statement
The studies involving humans were approved by Ethics Review Committee of the First Affiliated Hospital of Harbin Medical University. The studies were conducted in accordance with the local legislation and institutional requirements. The participants provided their written informed consent to participate in this study. ...
PMC10653384
Author contributions
MH, WL, HL
ZM: Writing – original draft. CX: Writing – original draft. HL: Writing – original draft. XG: Writing – original draft. XL: Writing – original draft. WL: Writing – original draft. XM: Writing – original draft. CY: Writing – original draft. MH: Writing – original draft. KZ: Writing – original draft. YH: Writing – origin...
PMC10653384
Acknowledgments
The authors thank the doctors and nurses of the First Affiliated Hospital of Harbin Medical University.
PMC10653384
Conflict of interest
The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.
PMC10653384
Publisher’s note
All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article, or claim that may be made by its manufacturer, is not guaranteed or ...
PMC10653384
References
PMC10653384
Purpose
paraplegia, CIVD
VASODILATION, PARAPLEGIA
Communicated by George Havenith.This study examined physiological and perceptual parameters related to cold-induced vasodilation (CIVD) in the fingers and toes of people with paraplegia and compared them with responses observed in able-bodied individuals.
PMC10363085
Methods
paraplegia
COLD, PARAPLEGIA
Seven participants with paraplegia and seven able-bodied individuals participated in a randomized matched-controlled study involving left-hand and -foot immersion in cold water (8 ± 1 °C) for 40 min during exposure to cool (16 ± 1 °C), thermoneutral (23 ± 1 °C), and hot (34 ± 1 °C) ambient conditions.
PMC10363085
Results
paraplegia
PARAPLEGIA
Similar CIVD occurrence was observed in the fingers in the two groups. In toes, three of the seven participants with paraplegia revealed CIVDs: one in cool, two in thermoneutral, and three in hot conditions. No able-bodied participants revealed CIVDs in cool and thermoneutral conditions, while four revealed CIVDs in ho...
PMC10363085
Conclusion
paraplegia, CIVD
PARAPLEGIA
Our findings demonstrated considerable inter-individual variability in CIVD responses in both the paraplegic and able-bodied groups. While we observed vasodilatory responses in the toes of participants with paraplegia that technically fulfilled the criteria for CIVD, it is unlikely that they reflect the CIVD phenomenon...
PMC10363085
Supplementary Information
The online version contains supplementary material available at 10.1007/s00421-023-05175-7.
PMC10363085
Keywords
Open access funding provided by HEAL-Link Greece.
PMC10363085
Introduction
CIVD, cold injury, paraplegia, heat loss
HEAT, COLD, PARAPLEGIA
Exposure to a cold stimulus causes vasoconstriction of the cutaneous vasculature to reduce heat loss (Tyler et al. It has been proposed that the purpose of the CIVD response may be cryoprotective, that is to minimize the risk of cold injury (Daanen and Ducharme The CIVD response is characterized primarily by the magnit...
PMC10363085
Materials and methods
PMC10363085
Experimental protocol
The study included a familiarization session and three experimental sessions. During the familiarization session, participants were informed about all data collection procedures/equipment and underwent anthropometric and body composition (Dual-energy X-ray absorptiometry; (Lunar model DPX Madison, WI).) assessments. Th...
PMC10363085
Measurements
PAD, HEART, COLD
Gastro-intestinal (Physiological and perceptual measurements during the experimental protocolGastro-intestinal temperature (Using surgical tape (3 M Transpore Tape, 3 M Canada), six ceramic chip skin thermistors (MA-100, Thermometrics) were attached on the lower part of the pad on the 2nd finger (i.e., index finger) of...
PMC10363085
Statistical analysis
The 20-s average values for Number of waves (Minimum temperature (Maximum temperature (Onset time (Peak time (Average temperature (Temperature amplitude (ΔA Shapiro–Wilks test was used to test the normality assumption in continuous variables, demonstrating that they were distributed normally. Chi-square tests were used...
PMC10363085
Results
PMC10363085
Frequency of CIVD
C)Colors, CIVD
HEAT, COLD
According to the above definition of CIVD, we observed 75 CIVDs in both groups, distributed as follows: 13 in the cool environment, 17 in the thermoneutral environment, and 45 in the hot environment (Heat map presenting the number of paraplegic and able-bodied participants that demonstrated a CIVD reaction for each min...
PMC10363085
Characteristics of CIVD
SD
SKIN, COLD
The characteristics of CIVD waves across groups and environments are shown in Table S1 as well as in Figs. Skin temperature in the fingers and toes as well as skin blood flow (mean ± SD) in the cool environment (16 ± 1 °C) in the two groups. The first 20 min (00:00–00:20) indicate data collected during the baseline pha...
PMC10363085
Physiological responses
COLD
The physiological parameters monitored during the protocol are shown in Table S2 as well as Figs. Physiological parameters (mean ± SD) during exposure to the cool environment (16 ± 1 °C) in the two groups. The first 20 min (00:00–00:20) indicate data collected during the baseline phase, the next five min (00:20–00:25) ...
PMC10363085
Perceptual data
paraplegia, pain
HEAT, COLD, PARAPLEGIA
Perception of pain and distress in the hand during the cold water immersion were markedly lower for the paraplegic group (small to very large effect sizes; Table S2). Compared to the able-bodied participants, the finger tactile sensitivity of the paraplegic group tended to be higher when assessed using the Semmes–Weins...
PMC10363085
Discussion
paraplegia
COLD, PARAPLEGIA
The principal finding of the present study is the presence of a vasodilatory response in the fingers and toes of participants with paraplegia during immersion of the hands and feet in cold water; a response that is defined as a CIVD in able-bodied individuals. The elevations in the digit skin temperature undoubtedly re...
PMC10363085
Effect of paraplegia and ambient temperature on the CIVD response based on finger/toe temperature
paraplegia, CIVD
HEAT, VASODILATION, COLD, PARAPLEGIA
In able-bodied participants, immersion of the hands and feet in cold water during exposure to a hot environment elicited a CIVD response in fingers and toes. The CIVD response in the toes was absent during exposure to thermoneutral and cool ambient conditions. The participants with paraplegia showed a similar reduction...
PMC10363085
Effect of paraplegia and ambient temperature on skin blood flow and CIVD
cord injury, paraplegia
PARAPLEGIA
The most pertinent issues with regards to the observed indirect evidence (i.e., skin temperature) of the skin blood flow responses in the fingers and toes of participants with paraplegia are: can the responses be defined as CIVDs in the same manner as in the able-bodied population, or are these responses of a different...
PMC10363085
The possible implication of muscular and vascular atrophy
paraplegia
PARAPLEGIA
Compared to able-bodied individuals, participants with paraplegia demonstrated lower
PMC10363085
The contribution of central and peripheral mechanisms in the etiology of CIVD
paraplegia
COLD, PARAPLEGIA
The present study was designed with the view of contributing to the resolution of the issue regarding the contribution of central and peripheral (local) mechanisms in the initiation of CIVDs during immersion of either the hands or feet in cold water. We considered that our approach of comparing the CIVD response in fin...
PMC10363085
Limitations
paraplegia, CIVD
PARAPLEGIA
We did not monitor bladder stretching or urine production, which could have provided insightful information with regards to the unexplained fluctuations in skin temperature and blood flow of individuals with paraplegia. Also, it is important to note that we did not directly assess sympathetic vasomotor control in the f...
PMC10363085
Practical implications
paraplegia
DER, COLD, PARAPLEGIA
In regions with colder climates, it is often rare for individuals with paraplegia to venture outdoors during periods of extreme cold. Without feedback regarding the thermal status of their feet, they cannot appropriately behaviourally thermoregulate (i.e., adding more insulation, removing themselves from the cold, etc....
PMC10363085
Conclusions
paraplegia, CIVD
COLD, PARAPLEGIA
In conclusion, our findings demonstrated considerable inter-individual variability in CIVD responses in both the paraplegic and able-bodied groups. We observed vasodilatory responses in the fingers and toes of participants with paraplegia during immersion of the hands and feet in cold water; a response that is defined ...
PMC10363085
Supplementary Information
Below is the link to the electronic supplementary material.Supplementary file1 (PDF 303 kb)
PMC10363085
Author contributions
HAD
LT and ADF conceived and designed the research; LT, LGI and ADF performed the experiments; LT and ADF analyzed the data; LT and ADF interpreted the results of experiments; LT prepared the figures; LT, and ADF drafted the manuscript; LT, LGI, BKA, SSC, HAD, IBM, ADF edited and revised the manuscript; LT, LGI, BKA, SSC, ...
PMC10363085
Funding
Open access funding provided by HEAL-Link Greece. This study received no external funding.
PMC10363085
Data availability statement
The data that support the findings of this study are available from the corresponding author, upon reasonable request.
PMC10363085
Declarations
PMC10363085
Conflict of interest
The authors declare no conflict of interest.
PMC10363085
Ethical approval
The experimental protocol (ClinicalTrials.gov ID: NCT04215939) conformed to the standards set by the Declaration of Helsinki and was approved by the Bioethics Review Board of the University of Thessaly Department of Physical Education and Sport Science (protocol no.: 1320).
PMC10363085
Informed consent
Informed consent was obtained from all subjects involved in the study.
PMC10363085
Disclaimer
The opinions or assertions contained herein are the private views of the authors and are not to be construed as official or as reflecting the views of the U.S. Army, the Department of Defense, or the U.S. Government. Approved for public release; distribution is unlimited. Citations of commercial organizations and trade...
PMC10363085
References
PMC10363085
Abstract
PMC10655060
Aims
HF, heart failure, T2DM
HEART FAILURE, RECURRENCE, TYPE 2 DIABETES MELLITUS, ATRIAL FIBRILLATION (AF)
Dapagliflozin has been widely used for the treatment of type 2 diabetes mellitus (T2DM) and heart failure (HF). However, data concerning the association between dapagliflozin and the recurrence of atrial fibrillation (AF), especially in patients following Cox-Maze IV (CMIV), are rare. We aim to explore the effect of da...
PMC10655060
Methods and results
The study of dapagliflozin evaluation in AF patients followed by CMIV (DETAIL-CMIV) is a prospective, double-blind, randomized, placebo-controlled trial. A total of 240 AF patients who have received the CMIV procedure will be randomized into the dapagliflozin group (10 mg/day,
PMC10655060
Conclusion
T2DM
RECURRENCE
DETAIL-CMIV will determine whether the sodium-glucose cotransporter-2 inhibitor dapagliflozin, added to guideline-recommended post-operative AF therapies, safely reduces the recurrence rate of AF in patients with and without T2DM or HF.
PMC10655060
Graphical Abstract
PMC10655060
Introduction
coronary heart disease, arrhythmia, cardiovascular adverse
HEART, CORONARY HEART DISEASE, ATRIAL FIBRILLATION (AF), ARRHYTHMIA
Atrial fibrillation (AF) is the most common arrhythmia. Based on data from the Framingham Heart Study (FHS), the prevalence of AF has increased three-fold over the last 50 years.A new oral hypoglycaemic drug, dapagliflozin, a sodium-glucose cotransporter-2 inhibitor (SGLT2i), was confirmed to reduce the risk of cardiov...
PMC10655060
Objectives
T2DM
RECURRENCE
Accordingly, we are conducting a randomized controlled trial to evaluate whether post-operative oral dapagliflozin can improve AF recurrence after CMIV, regardless of concomitant T2DM or HF.
PMC10655060
Study design
cardiac or cerebrovascular event, AF/AT, atrial flutter
ATRIAL FIBRILLATION, ATRIAL FLUTTER, ATRIAL TACHYCARDIA
This is a prospective, double-blind, randomized, placebo-controlled trial. The manufacturer of dapagliflozin did not provide any financial support or take part in the design of the study. This study is investigator initiated, and the study protocol was in accordance with the Declaration of Helsinki and approved by the ...
PMC10655060
Current status of the trial
RECRUITMENT
The study has not yet begun. The start date of recruitment is expected to be 1 September 2023, and the completion of recruitment is expected by late June 2024.
PMC10655060
Patient population
cerebral apoplexy, vascular disease, hyperthyroidism, apoplexy, T2DM
HYPERTHYROIDISM, ACUTE MYOCARDIAL INFARCTION, APOPLEXY, VASCULAR DISEASE
Patients who were hospitalized in Beijing Anzhen Hospital for CMIV of AF were screened for inclusion with written informed consent was obtained from all participants. Patients aged 18 or older with AF undergoing first-time isolated or concomitant CMIV, regardless of concomitant T2DM or HF, were eligible for inclusion. ...
PMC10655060
Randomization and blinding
SEPARATION
The random allocation sequence was generated with computer-generated random numbers by the study statistician, and sequentially numbered opaque envelopes containing the treatment allocation were utilized to conceal the sequence. Participants will be randomly assigned 1:1 to dapagliflozin (10 mg once a day) or matched p...
PMC10655060
Surgical procedure
RA, bipolar, transmurality
WEST, ARRESTED
All the CMIV procedures were performed under cardiopulmonary bypass (CPB) with median sternotomy. To reduce the variation among surgeons, we require the CMIV to be performed by qualified surgeons. After the initiation of normothermic CPB, both sets of pulmonary veins are then bluntly dissected, mobilized, and encircled...
PMC10655060
Study intervention and background medication
Following CMIV, patients will be randomly assigned to oral dapagliflozin therapy or matched placebo in blocks of ten. Dapagliflozin will be initiated on the first morning after CMIV at a dose of 10 mg once daily until 3 months post-operation. The start date of the observation will be set as the first intervention date....
PMC10655060
Outcome measurement
malignant arrhythmias, AF/AT, cardiovascular death, atrial tachycardia, atrial tachyarrhythmia, stroke, MACCEs, atrial flutter
STROKE, EVENTS, ATRIAL FLUTTER, ATRIAL TACHYCARDIA
Primary endpoint is any documented atrial tachyarrhythmia [AF, atrial flutter or atrial tachycardia (AF/AT)] lasting 30 s following a blanking period of 3 months after CMIV.Secondary endpoints are as follows: (i) any documented atrial tachyarrhythmia [AF, (AF/AT)] at the 6-month follow-up monitoring session after CMIV;...
PMC10655060
Data collection
arrhythmia, arrhythmia-related
EVENTS, EVENT, ARRHYTHMIA, COMPLICATIONS
Study visits are scheduled to occur before randomization and at 3, 6, and 12 months; a detailed medical history, a routine blood pressure measurement and physical examination, laboratory testing, and 48- to 72-h Holter monitoring will be conducted at each visit. All patients with arrhythmia-related symptoms, especially...
PMC10655060
Adverse events monitoring and interim analysis
DIABETIC KETOACIDOSIS, ADVERSE EVENT, EVENTS, HYPOGLYCAEMIA
Adverse events will be constantly monitored by investigators during the process of the study through regular medical check-ups, and the details will be immediately reported to the principal investigator once an AE occurs, regardless of the causal relationship with dapagliflozin. Only serious AEs and AEs of interest or ...
PMC10655060
Sample size estimation
RECURRENCE
According to our published work, the recurrence rate of AF after CMIV is 37.9% in patients without oral dapagliflozin therapy.
PMC10655060
Statistical analysis
REGRESSION, EVENT, RECURRENCE
Analyses will be performed according to the intention-to-treat principle. Patients who are lost or die before completing the 3-month follow-up visit will be excluded from the analysis of the primary endpoint. The proportions of patients with recurrence at follow-up in the dapagliflozin group and the placebo group will ...
PMC10655060
Discussion
T2DM
RECURRENCE, EVENTS, TUMOUR NECROSIS, INFILTRATION
Dapagliflozin has emerged as a powerful agent to reduce the incidence of cardiovascular events in patients with T2DM and HF. Although the mechanisms of dapagliflozin with cardiovascular events have not been fully demonstrated, studies have shown that dapagliflozin can reduce the production of the inflammatory cytokines...
PMC10655060
Authors’ contributions
Z.P., Y.X.Y., F.O., K.H., and X.B.Y. conducted the study, reviewed the manuscript, and contributed to the discussion. Z.P. wrote and edited the manuscript. Z.P., Y.X.Y., F.O., K.H., and X.B.Y. made substantial contributions to the conception and design and acquisition of data, drafted the article or revised it critical...
PMC10655060
Funding
None declared
PMC10655060
Data availability
All relevant data are within the manuscript and its Supporting Information files.
PMC10655060
Clinical trial registration number
NCT05816733.
PMC10655060
Ethics approval
The study protocol was in accord with the Declaration of Helsinki and approved by the ethics committee of Beijing Anzhen Hospital (No. KS2023017).
PMC10655060
References
PMC10655060
Introduction
Assessment in the educational field commonly uses Multiple Choice Questions (MCQs), because this question type offers high reliability and easy machine-marking. However, it also allows for cueing (i.e., answering questions based on cues in the question or answer options rather than on content knowledge) and stimulates ...
PMC10348524
Methods
PMC10348524
Setting
AEES
This study was simultaneously performed in two different student cohorts (cohort 2019 and cohort 2020) using the same study design. First year students (cohort 2020) followed the fundamental course “(A) Set-up of both courses (RM and DA) with the formative exam and contents, summative exam and contents, and the Automat...
PMC10348524
Formative exam
To determine reliability, discrimination, cueing effects, and students’ insights in the formative exams of the RM and DA courses, students were randomly assigned to a group starting with MCQs (RM-MCQAfter having finished the first part of the formative exam (either MCQs or VSAQs) students were asked to rate three state...
PMC10348524
Summative exam
AEES
The summative exams of RM and DA were rewritten to replace part of the MCQs with VSAQs (45 in RM and 16 in DA). For RM, this was done through rewriting existing MCQs, whereas for DA, a 2-hour workshop was organized for teachers on how to write VSAQs. Question writers in both courses received written instructions about ...
PMC10348524
Statistical analysis
Continuous variables are presented as mean (standard deviation) or median (interquartile range) depending on their distribution. Categorical variables are presented as number (proportion). Reliability was determined by calculating the Cronbach’s α or the VSAQs and MCQs in both formative exam formats, which is a measure...
PMC10348524
Ethical approval
This study was reviewed and approved by the Educational Research Review Board of the Leiden University Medical Center (file number: OEC/ERRB/20201208/1).
PMC10348524
Results
Of the 335 students who took the formative exam in RM, 216 students were included in our study. In DA, 159 of the 259 students who took the formative exam were included (
PMC10348524
Reliability and discrimination
We compared the VSAQs of students starting with VSAQs with the MCQs of students starting with MCQs. This comparison reflects the results of the VSAQs and MCQs that are not influenced by prior questions. VSAQs had higher reliability compared to MCQs (Cronbach’s α 0.74 vs. 0.57 in RM; 0.87 vs. 0.83 in DA for VSAQs vs. MC...
PMC10348524
Cronbach’s alpha, average R
MCQ, multiple choice question; VSAQ, very short answer question; SD, standard deviation.
PMC10348524
Acceptability
In the initially collected data, the average reviewing time per VSAQ by one teacher in the summative exam of DA (7 VSAQs, 308 students) was 2 minutes and 20 seconds (SD 52 seconds). Additionally, on average 2 minutes and 9 seconds (SD 2 minutes and 36 seconds) were spent replying to comments and consultation of other t...
PMC10348524
Secondary outcomes
POSITIVE
Positive cueing, defined as a correctly answered MCQ with an incorrectly answered equivalent VSAQ, occurred on average more often per student in RM-VSAQ
PMC10348524
Positive and negative cueing per person in MCQ
MCQ, multiple choice question; VSAQ, very short answer question; IQR, interquartile range.
PMC10348524
Positive and negative cueing per question in MCQ
MCQ, multiple choice question; VSAQ, very short answer question; IQR, interquartile range.When asked whether they found the questions easy, students who had been answering only VSAQs more often disagreed compared to students who had been answering MCQs only in the DA course (EQ2: 3, IQR 2–3 vs. 2, IQR 2–2), but student...
PMC10348524
Students’ experiences and grade estimates of the MCQs and VSAQs in the formative exam.
Distribution of the answers given to the 5-point Likert scale evaluation questions halfway through the exam after the MCQs or VSAQs and at the end of the exam; and estimates of their grade halfway through the exam in RM (A, B, C) and DA (D, E, F).
PMC10348524
Discussion
POSITIVE
In this study we aimed to externally validate the earlier results regarding reliability, discrimination, and acceptability of VSAQs compared to MCQs in a cohort of Dutch medical undergraduate students, based on earlier work by Sam The higher reliability and discrimination but lower test scores of VSAQs compared to MCQs...
PMC10348524
Supporting information
PMC10348524
Median (IQR) scores of the 5-point Likert scale evaluation questions (EQ1-3 and EQ5-9) and estimated grade question (EQ4) in the formative exam.
EQ1-4 halfway of the exam after the MCQs (MCQ(DOCX)Click here for additional data file.
PMC10348524
Distribution of the answers given to the 5-point Likert scale evaluation questions halfway of the formative exam after MCQs (MCQ
(DOCX)Click here for additional data file.
PMC10348524
Distribution of the answers given to the 5-point Likert scale evaluation questions at the end of the formative exam.
(DOCX)Click here for additional data file.
PMC10348524
Median (IQR) scores and distribution of the answers given to the 5-point Likert scale evaluation questions after the summative exam.
(DOCX)Click here for additional data file.
PMC10348524
Median (IQR) scores of the 5-point Likert scale questions on constructive alignment after the summative exam (1: strongly disagree, 2: disagree, 3: neutral, 4: agree, 5: strongly agree).
(DOCX)Click here for additional data file.The authors wish to thank all members of the research group of the Centre for Innovation in Medical Education at Leiden University Medical Centre for their critical appraisal of the research protocol and all the students for their willingness to participate and valuable feedbac...
PMC10348524
References
PMC10348524
Purpose
MBC
METASTATIC BREAST CANCER
A substantial need for effective and safe treatment options is still unmet for patients with heavily pre-treated human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer (MBC). Herein, we assessed the efficacy and safety of pyrotinib plus trastuzumab and chemotherapy in patients with heavily tr...
PMC9823079
Methods
BRAIN METASTASES, DISEASE
In this single-arm exploratory phase II trial, patients with HER2-positive MBC previously treated with trastuzumab plus lapatinib or pertuzumab, received pyrotinib plus trastuzumab and chemotherapy. The primary end point was progression-free survival (PFS) in the total population (TP). Secondary end points included PFS...
PMC9823079