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Funding
Open Access funding enabled and organized by Projekt DEAL.
PMC10520109
Data availability
Original data is shown in this manuscrip.
PMC10520109
Declarations
PMC10520109
Conflict of interest
The authors have no relevant financial or non-financial interests to disclose.
PMC10520109
References
PMC10520109
Keywords
We tested for feasibility, acceptance, and “non-inferiority” of small-group teaching applying blended learning (i.e., the integration of face-to-face and online instruction) to problem-based learning (bPbL) compared to conventional PbL (cPbL). In a just pre-pandemic, randomised controlled trial, 317 students attended e...
PMC9581769
Introduction
The COVID-19 pandemic has impacted university teaching worldwide. Within a very short time, universities had to convert their face-to-face courses to digital formats. Meanwhile, many universities are returning to face-to-face teaching, which inevitably raises the question of whether and to what extent to return to conv...
PMC9581769
Methods
PMC9581769
Setting
METABOLIC SYNDROME, EVENTS, EVENTS
The (pre-pandemic) setting of our study was a course dealing with the diagnosis of and treatment options for metabolic syndrome. This interdisciplinary course is a so-called competence area (literal translation of “Kompetenzfeld”), a format developed as element of the Cologne medical model curriculum (Zims et al. Cours...
PMC9581769
Intervention
It is noteworthy that all students had recently attended another 6-week PbL course on site and were therefore familiar with PbL. In the blended PbL (bPbL) of our study, the first meeting of the PbL groups did not take place on site as usual, but the live communication took place exclusively via a written online chat on...
PMC9581769
Study design
In a pilot phase (winter term 2017/2018), students were asked to voluntarily participate in bPbL groups. Nineteen students from two bPbL groups and 29 students from three cPbL attended the pilot study, i.e. they filled in the questionnaires described below. The pilot phase was to check for technical feasibility of our ...
PMC9581769
Questionnaires
At the time of the final exam, students were asked to fill in paper-based questionnaires. These questionnaires referred to students’ attitudes towards computer-based learning (CbL), their familiarity with the ILIAS platform, satisfaction with the course (including work of the PbL group, satisfaction with the tutor, per...
PMC9581769
Interviews
Semi-structured group interviews were conducted with 7 bPbL and 7 cPbL groups. Entire groups were each interviewed by their PbL tutor (
PMC9581769
Statistics and ethical issues
With our quantitative analysis, we tested the hypothesis that there are differences between cPbL and bPbL groups in evaluation, exam or lecture attendance to imply non-inferiority if the initial hypothesis were to be rejected. For comparison of exam results and evaluation items, a Mann–Whitney test was applied. Proport...
PMC9581769
Results
PMC9581769
Evaluation results
During the pilot phase, students voluntarily attending a bPbL group appeared to be significantly less sceptical about CbL compared to students who did not choose the bPbL approach (not shown). In the randomised main study, however, we found no difference between students having attended bPbL or cPbL groups with respect...
PMC9581769
Attendance of lectures on site and use of videotaped lectures
While 120 out of 153 (78%) cPbL students reported having attended at least one lecture on site, only 41 out of 65 (63%) bPbL students did (Percentage of students having attended at least one lecture on site (
PMC9581769
Exam preparation and results
The amount of time students spent on the course in addition to PbL group sessions was similar (median of 3, i.e. 2–3 h in both cPbL and bPbL groups). With respect to the results in the final summative exam, there also was no difference between students attending a bPbL or cPbL group, respectively (Fig. Results in a sum...
PMC9581769
Results obtained from interviews
Categories derived from interviews with cPbL and bPbL groups can be taken from Table Main categories and sub-categories derived by content analysis from interviews with student groups (In the following, “C “ indicates quotes from interviews with cPbL groups and “I” quotes from bPbL groups.
PMC9581769
Students’ statements in support of blended PbL
EVENT, SAID
The categories relating to advantages of bPbL that were most frequently touched upon overall, but also by cPbL and bPbL groups, respectively, were the C3, 57–59: “This is perhaps the advantage for people who now have a longer journey to get here”I8, 8-9: “One advantage was that you could stay at home and not drive to u...
PMC9581769
bPbL-sceptical statements by students
SAID, -20
The category to which by far the most bPbL-sceptical statements could be assigned was “C8, 30–31: “Exactly, this answering one after the other, that probably doesn’t work in the chat”C9, 14-16: “I always have the feeling, like for example in a group chat now on WhatsApp, that it’s always so confused”I4, 42–43: “But now...
PMC9581769
Statements exclusively from either bPbL or cPbL students
SAID
There have been categories referring exclusively to statements from either bPbL or cPbL groups. With the exception of supportive statements from bPbL students regarding One bPbL student had concerns about I4, 30-32: “Because maybe I don’t want everything I said somewhere to be recorded and everyone else to be able to s...
PMC9581769
Discussion
fits
EVENTS
Shortly before the COVID-19 pandemic outbreak, we investigated whether the first of two PbL meetings could be realised by means of blended learning, i.e. in our study as an internet chat instead of on-site. We found that this bPbL approach was feasible and did not differ from cPbL in terms of student evaluation, additi...
PMC9581769
Limitations
There are some limitations of our study to be considered. As mentioned above, the fact that we conducted our study before the COVID-19 pandemic can be seen as both a disadvantage and an advantage. Although our intervention aimed at collaborative, not contextual learning, we did not analyse the PbL process itself, tutor...
PMC9581769
Acknowledgements
We thank the students for participating in the study and some colleagues for moderating online groups and/or interviewing the students.
PMC9581769
Author contribution
US, BR, YK, CS and JM designed the study. US, BR and JM collected the data. US and JM analysed the data. All authors were involved in writing the manuscript. All authors read and approved the final manuscript. The authors declare that all data were generated in-house and that no paper mill was used.
PMC9581769
Funding
Open Access funding enabled and organized by Projekt DEAL.
PMC9581769
Data availability
The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request.
PMC9581769
Declarations
PMC9581769
Conflict of interest
The authors declare no competing interests.
PMC9581769
Ethics approval
This study was approved by the Ethics Committee of the Medical Faculty of the University of Cologne (ID: 18–106).
PMC9581769
Consent to participate
The analysis of data as performed is authorised by a student consent form signed when enrolling to medical studies at the University of Cologne (“Declaration of voluntariness of attending the reformed medical curriculum”, including an agreement regarding “the collection, storage and scientific evaluation of my personal...
PMC9581769
Consent for publication
Not applicable.
PMC9581769
References
PMC9581769
Background
cognitive decline
The effects of combined training can be affected by training characteristics such as frequency, session length, and duration. No empirical studies to date have directly compared how combined physical and cognitive training offered at different training frequencies affects cognitive function for older adults with cognit...
PMC9926662
Methods
cognitive decline
A quasi-experimental study was conducted in community facilities and day care centers. The study assigned 89 older adults with cognitive decline into high-frequency (HF) or low-frequency (LF) training groups. The participants received 90- to 105-min training sessions, one (LF) or three (HF) times a week, for 12 weeks. ...
PMC9926662
Results
The HF group demonstrated greater improvement in immediate memory measured by the WL-IM (
PMC9926662
Conclusions
cognitive decline
Our study indicated that the different training frequency of combined physical and cognitive training may result in benefits on different cognitive functions in older adults with cognitive decline. These findings may assist clinical practitioners in choosing appropriate training frequencies based on various interventio...
PMC9926662
Trial registration
ClinicalTrials.gov Identifier NCT03619577 (08/08/2018).
PMC9926662
Keywords
PMC9926662
Introduction
cognitive decline, dementia, cognitive impairment
With a rapidly growing aging population, the incidence of cognitive decline, such as mild cognitive impairment and dementia, is increasing [Accumulating evidence indicates that physical exercise combined with cognitive training may improve cognitive function for older adults with cognitive decline [Zhu et al. (2016) in...
PMC9926662
Method
PMC9926662
Participants
dementia, informant-reported cognitive complaints
HEART FAILURE, MYOCARDIAL INFARCTION
The local ethics committee and institutional review board approved the study protocol. Participants were recruited from local community facilities and day care centers. The inclusion criteria were (1) age ≥ 60 years, (2) having self- or informant-reported cognitive complaints, (3) the ability to follow instructions (≥ ...
PMC9926662
Study design and procedure
fatigue
This study was a multicenter and controlled trial. Fourteen local community facilities and day care centers in northern Taiwan were enrolled between 2018 and 2021. Participants engaged in high-frequency (HF group) or low-frequency (LF group) sessions of combined physical and cognitive training. For the HF group, we cho...
PMC9926662
Intervention
Training sessions were conducted in groups of 5 to 10 participants, led by a certified therapist. Participants engaged in physical exercise for 45 to 55 min, followed by 45 to 50 min of cognitive training. The participants performed 10 min of warm-up, followed by 30 to 35 min of physical exercise, and ended with 5 to 1...
PMC9926662
Outcome measures
cognitive decline, WL
The participants were assessed before and immediately after the training programs. The assessors were masked to the group of participants when they conducted the evaluation. We used reliable and valid assessments, including the Montreal Cognitive Assessment (MoCA), Digit Symbol Substitution Test (DSST) of the Wechsler ...
PMC9926662
Statistical analysis
Skewness and kurtosis were measured, and all values were between 1 and − 1, which suggests the normal distribution of our data. Demographic variables and baseline characteristics were compared between the two groups using independent
PMC9926662
Discussion
cognitive impairments, cognitive decline, dementia
To our knowledge, this study is the first prospective study to directly compare the effects of combined physical and cognitive training in different frequencies on cognitive function for older adults with cognitive decline. We identified that the different training frequency of combined physical and cognitive training ...
PMC9926662
Conclusion
cognitive decline
This is the first prospective study to directly compare the effects of different training frequencies of combined physical and cognitive training on cognitive function for older adults with cognitive decline. Our study indicated that combined physical and cognitive training at different training frequencies may benefit...
PMC9926662
Acknowledgements
We thank all participants who participated in this study.
PMC9926662
Authors’ contributions
RECRUITMENT
ICC and CYW contributed to the study design, coordination, and project management. ICC, ICC, and CYW interpreted data and drafted and revised the manuscript. ICC and KHS performed the data analyses and helped draft the manuscript. YRW participated in subject recruitment and provided consultation. All authors have read ...
PMC9926662
Funding
This study was supported by Chang Gung Memorial Hospital (CMRPD1M0041, CMRPD1M0042, BMRP553, BMRPJ29); the Ministry of Science and Technology, Taiwan (MOST 109–2314-B-182–008-MY2; MOST 110–2314-B-182–014; MOST 111–2314-B-182–039-MY3); and the Healthy Aging Research Center, Chang Gung University from the Featured Areas ...
PMC9926662
Availability of data and materials
The data sets used and/or analyzed during the current study are available from the corresponding author on reasonable request.
PMC9926662
Declarations
PMC9926662
Ethics approval and consent to participate
The study was performed in accordance with the Declaration of Helsinki and was approved by the National Taiwan University Research Ethics Committee (201711EM006) for studies involving humans. All participants provided the informed consent.
PMC9926662
Consent for publication
Not applicable.
PMC9926662
Competing interests
The authors declare no competing interests.
PMC9926662
References
PMC9926662
1. Introduction
pneumoniae, AB, respiratory infectious disease, asthmatic bronchitis
ASTHMATIC BRONCHITIS, VIRUS, ASTHMATIC BRONCHITIS, INFLUENZA
Academic Editor: Sandip K MishraIn order to explore the clinical efficacy of knowledge, information, and action theory combined with clinical nursing in children with asthmatic bronchitis (AB) and to analyze the influencing factors of poor prognosis, a total of 98 children with AB in our hospital from January 2021 to A...
PMC9957635
2. Related Work
chest tightness, respiratory failure, wheezing, hypoxemia, pulmonary hypertension, shortness of breath
RESPIRATORY FAILURE, DISEASES, PULMONARY HYPERTENSION
The theory of knowledge, belief, and action was the most commonly used model to explain the influence and change of personal knowledge and beliefs on health behavior. It could help clients change their health beliefs, build a health knowledge system, and establish health beliefs [The repeated episodes of wheezing, shor...
PMC9957635
3. Observation Indicators and Statistical Methods
congenital heart disease, wheezing, pulmonary wheezing, mental disorders, immunodeficiency and respiratory failure
VIRUS, DISEASE, HEARING IMPAIRMENTS, ADVERSE REACTION, REGRESSION, COLD
The baseline data of 98 children with AB who are diagnosed and treated in our hospital from January 2021 to August 2022 are analyzed, and they are randomly divided into a combined group and a single group. The inclusion criteria are as follows: (1) meet the diagnostic criteria of AB disease, (2) high degree of treatmen...
PMC9957635
4. Pulmonary Function and Univariate Analysis of the Influencing Factors
PMC9957635
4.1. Baseline Data
PMC9957635
4.2. Clinical Efficacy of Research Subjects
PMC9957635
4.3. Pulmonary Function of Subjects before and after Intervention
PMC9957635
4.4. Univariate Analysis of the Influencing Factors of Poor Prognosis in Children with AB
PMC9957635
4.5. Binary Logistic Regression Analysis of Risk Factors Affecting the Prognosis of Children with AB
PMC9957635
5. Conclusion
allergies
RESPIRATORY TRACT INFECTION, ALLERGIES
Family history, repeated respiratory tract infection, and history of allergies are independent risk factors for the prognosis of children with AB. The application of the theory of knowledge, belief, and action combined with clinical intervention can effectively improve the clinical symptoms of children with AB and impr...
PMC9957635
Data Availability
The simulation experiment data used to support the findings of this study are available from the corresponding author upon request.
PMC9957635
Conflicts of Interest
REGRESSION
The authors declare that there are no conflicts of interest regarding the publication of this paper.FEV1 levels before and after intervention.FVC levels before and after intervention.FEV1/FVC levels before and after intervention.Analysis of baseline data of research subjects (Analysis of the clinical efficacy of the re...
PMC9957635
Key Points
PMC10236240
Question
mucinous appendiceal adenocarcinoma
Is fluoropyrimidine-based systemic chemotherapy effective in treating patients with inoperable low-grade mucinous appendiceal adenocarcinoma?
PMC10236240
Findings
TUMOR GROWTH
In this randomized crossover trial that included 24 patients, there was no significant difference in tumor growth between treatment and observation time periods.
PMC10236240
Meaning
appendiceal adenocarcinoma, mucinous appendiceal adenocarcinoma
APPENDICEAL ADENOCARCINOMA
These findings suggest that patients with low-grade mucinous appendiceal adenocarcinoma did not derive clinically meaningful benefit from systemic fluoropyrimidine-based chemotherapy.This randomized crossover trial evaluates the effectiveness of fluoropyrimidine-based systemic chemotherapy in patients with inoperable l...
PMC10236240
Importance
tumor, Appendiceal adenocarcinoma
DISEASE, APPENDICEAL ADENOCARCINOMA, TUMOR, RARE DISEASE
Appendiceal adenocarcinoma is a rare tumor, and given the inherent difficulties in performing prospective trials in such a rare disease, there are currently minimal high-quality data to guide treatment decisions, highlighting the need for more preclinical and clinical investigation for this disease.
PMC10236240
Objective
mucinous appendiceal adenocarcinoma
To prospectively evaluate the effectiveness of fluoropyrimidine-based systemic chemotherapy in patients with inoperable low-grade mucinous appendiceal adenocarcinoma.
PMC10236240
Design, Setting, and Participants
cancer, peritoneal carcinomatosis
PERITONEAL CARCINOMATOSIS, CANCER, BOWEL OBSTRUCTION, APPENDICEAL ADENOCARCINOMA, MAY
This open-label randomized crossover trial recruited patients at a single tertiary care comprehensive cancer center from September 2013 to January 2021. The data collection cutoff was May 2022. Enrollment of up to 30 patients was planned. Eligible patients had histological evidence of a metastatic low-grade mucinous ap...
PMC10236240
Interventions
Patients were randomized to either 6 months observation followed by 6 months of chemotherapy, or initial chemotherapy followed by observation.
PMC10236240
Main Outcomes and Measures
TUMOR GROWTH, COMPLICATIONS, SECONDARY
The primary end point was the percentage difference in tumor growth in treatment and observation groups. Key secondary end points included patient-reported outcomes in the chemotherapy and observation periods, objective response rate, rate of bowel complications, and differences in overall survival (OS).
PMC10236240
Results
Tumor
TUMOR GROWTH, TUMOR
A total of 24 patients were enrolled, with median (range) age of 63 (38 to 82) years, and equal proportion of men and women (eg, 12 men [50%]); all patients had ECOG performance status of 0 or 1. A total of 11 patients were randomized to receive chemotherapy first, and 13 patients were randomized to receive observation...
PMC10236240
Conclusions and Relevance
APPENDICEAL ADENOCARCINOMA, TUMOR GROWTH
In this prospective randomized crossover trial of systemic chemotherapy in patients with low-grade mucinous appendiceal adenocarcinoma, patients did not derive clinical benefit from fluorouracil-based chemotherapy, given there were no objective responses, no difference in OS when treatment was delayed 6 months, and no ...
PMC10236240
Trial Registration
ClinicalTrials.gov Identifier:
PMC10236240
Introduction
PMP, high-grade tumors, Appendiceal adenocarcinoma, appendiceal tumors, heterogenous disease
CLINICAL SYNDROME, APPENDICEAL ADENOCARCINOMA, CAVITY, INFILTRATING, PSEUDOMYXOMA PERITONEI, HYPOCELLULAR
Appendiceal adenocarcinoma (AA) is both a rare and heterogenous disease, with marked contrast in the natural history of low-grade vs high-grade tumors (5-year overall survival [OS], 68% vs 7%).Histologically low-grade appendiceal tumors are generally hypocellular with abundant mucin and pushing, as opposed to infiltrat...
PMC10236240
Methods
Cancer
CANCER
From September 2013 to January 2021, we conducted a prospective randomized crossover trial in patients with low-grade mucinous AA. The University of Texas MD Anderson Cancer Center (MDACC) institutional review board approved the trial protocol in
PMC10236240
Patients
malignancy, tumor, CRS
ONCOLOGY, TUMOR
Eligible patients had histological evidence of a metastatic low-grade (defined as well- or well-to-moderate–differentiated) mucinous AA, with radiographic images demonstrating the presence of PMP, and were not considered candidates for complete CRS. Surgical candidacy was determined by consultation with peritoneal surf...
PMC10236240
Study Design and Treatment
Our study was a single-center, open-label, randomized trial with a crossover design. Eligible patients were randomized to 1 of 2 groups (
PMC10236240
Participant Recruitment Flowchart
Total study duration was 12 months. CT indicates computed tomography.
PMC10236240
End Points and Assessments
death, mucinous and cystic lesions, Tumor, cancer, bowel obstruction
TUMOR, BOWEL PERFORATION, CANCER, BOWEL OBSTRUCTION, COMPLICATION, SECONDARY, CAVITY, APPENDIX CANCER, TUMOR GROWTH, COMPLICATIONS
The primary end point was the difference in tumor growth (percentage change), using the mpRECIST method, between the chemotherapy and observation periods. The mpRECIST was developed for this trial specifically to address the limitations of standard RECIST in appendix cancer. mpRECIST measures 5 lesions (mucinous and cy...
PMC10236240
Patient-Reported Outcomes
peritoneal disseminated disease from, Anxiety, anxiety-specific Speilberger, Cancer
OVARIAN CANCER, SECONDARY, CANCER
An additional secondary end point was difference in quality of life (QOL) between the treatment and observation periods. QOL was determined using 3 different questionnaires: the European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30); the ovarian cancer-specific EOR...
PMC10236240
Statistical Analysis
tumor
MAY, TUMOR
To estimate effect size, 2 readers (K.P.R. and M.J.O.) retrospectively calculated mpRECIST in 5 patients with low-grade mucinous AA. The mean change in tumor size over a 6-month time period in patients receiving treatments was a 1.6% increase; in those without treatment, the increase was 9%. Based on these preliminary ...
PMC10236240
Results
PMC10236240
Patient Characteristics and Disposition
tumor, tumors
TUMOR, TUMORS, APPENDICEAL CANCER
Between December 2013 and January 2021, a total of 24 patients were enrolled in the study, with median (range) age of 63 (38-82) years and an equal proportion of men and women (eg, 12 men [50%]); all patients had ECOG performance status of 0 or 1. Eleven patients were randomized to chemotherapy first, and 13 patients w...
PMC10236240
Efficacy
TUMOR GROWTH
Fifteen patients completed the full 12-month study period and were available to evaluate the primary end point of difference in tumor growth between treatment and observations periods; there was not a significant difference (8.4%; 95% CI, 1.5%-15.3% vs 4.0% 95% CI, −0.1% to 8.0%;
PMC10236240
Tumor Growth and Percentage Change in Tumor Size Between Observation and Treatment Groups
Tumors, mucinous peritoneal disease, mucinous disease
TUMORS, CAVITY
Measured using modified peritoneal Response Evaluation Criteria in Solid Tumors, a novel quantitative measuring system designed for mucinous peritoneal disease, which measures up to 5 areas of mucinous disease in the abdominal cavity. Numbers indicate patient IDs.Median (range) OS for the entire cohort was 53.2 (8.1 to...
PMC10236240
Kaplan-Meier Curves Showing Overall Survival of All Patients and Between Groups
Crosses indicate censoring.
PMC10236240
Spider Plots Showing Tumor Markers Level Over Time
cancer
CANCER
CA indicates cancer antigen; CEA, carcinoembryonic antigen.
PMC10236240
Safety
The composite safety outcome measure was similar between treatment and observation and between groups (eTable 6 in
PMC10236240
Patient-Reported Outcomes
fatigue
Fifteen patients completed the patient-reported outcome questionnaires at both 6 and 12 months and were available for paired analyses. EORTC QLQ-C30 role function score, fatigue score, and financial difficulties scores were significantly increased during treatment relative to observation indicating worse quality of lif...
PMC10236240
Quality of Life Questionnaire Individual Scores Between Observation and Treatment Periods
Cancer
CANCER
Tan bars indicate mean score. EORTC QLQ indicates European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire, which ranges from 1 to 100, with higher subscale scores indicating worse levels of functioning.
PMC10236240
Discussion
DISEASE, TUMOR GROWTH, BOWEL PERFORATION
This randomized crossover trial found that fluoropyrimidine-based chemotherapy was not effective for patients with low-grade mucinous AA, as there was not a single objective response and not a significant difference in tumor growth while during chemotherapy vs observation. Due both to the rarity and heterogeneity of AA...
PMC10236240