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Funding | Open Access funding enabled and organized by Projekt DEAL. | PMC10520109 |
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Data availability | Original data is shown in this manuscrip. | PMC10520109 |
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Declarations | PMC10520109 |
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Conflict of interest | The authors have no relevant financial or non-financial interests to disclose. | PMC10520109 |
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References | PMC10520109 |
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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 either bPbL or cPbL groups. The first meeting of the bPbL groups took place online via written internet chat, while cPbL groups met on site. All groups met on site the second time. All students had the opportunity to attend lectures either on site or as videos on demand. We analysed student evaluation data, results in a final summative exam, attendance of lectures on site and use of lecture videos. Furthermore, we performed a qualitative analysis of student statements made in semi-structured group interviews about pros and cons of the bPbL approach. There was no difference between students of either bPbL or cPbL groups with respect to exam results (score: 14.3 ± 2.8 vs. 13.8 ± 2.7) or course evaluation. However, relatively more bPbL than cPbL students reported having used lecture videos, while the proportion of those attending lectures on-site was higher among cPbL students. Interviews revealed that some of the bPbL students’ experiences were unexpected and feared disadvantages seemed to be less severe than expected. Participation in a blended PbL format did not worsen course evaluations or exam results, but seemed to influence lecture attendance. The combination of face-to-face and digital elements could be suitable as a hybrid approach to digital instruction in the post-pandemic era.Open Access funding enabled and organized by Projekt DEAL. | PMC9581769 |
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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 conventional formats as well. Several surveys show that students would like to see a combination of face-to-face teaching and digital approaches, such as blended learning (Amir et al. Our main intervention was conducting the first PbL session as a written Internet chat instead of an on-site meeting, i.e. only the communication channel was different. Our study therefore aimed at collaborative learning in the broader sense of a non-inferiority study compared to conventional PbL (cPbL), which throughout takes place on site. We analysed student evaluation data, results in a final summative single-choice exam, as well as attendance of lectures on site and use of lecture videos. Furthermore, we performed a qualitative analysis of student statements made in semi-structured group interviews about pros and cons of the blended PbL approach. | PMC9581769 |
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Methods | PMC9581769 |
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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. Course sequence and differences due to the intervention. Events in grey shaded boxes were the same for all students. Participation in events in bold framed boxes was compulsory. *First PbL meeting as a written Internet chat (bPbL groups) or on site (cPbL groups). | PMC9581769 |
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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 the ILIAS learning platform ( | PMC9581769 |
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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 approach, to validate the questionnaire (see below), and to check for feasibility of our guideline for semi-structured interviews. The main study was a randomised controlled trial. Thus, in the main study phase, 317 students were randomly allocated to 12 bPbL and 27 cPbL groups, respectively. Random numbers generated in Excel decided which PbL group the students participated in and thus whether this was a cPbL or a bPbL group. Since the study was also intended to investigate the feasibility of this blended PbL approach, and since it was unclear whether the students might be at a (perceived) disadvantage, we decided to use fewer bPbL groups than cPbL groups. While attendance of the PbL meetings was mandatory, filling in the questionnaire was voluntary. The final written exam was a summative exam, so most students took it at the end of the course. | PMC9581769 |
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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, perceived exam preparation), lecture attendance (either on site or by watching the videos), and the learning time spent apart of the PbL meetings. Items on CbL and tutor qualification were taken from questionnaires used in previous studies (Matthes et al. | PMC9581769 |
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Interviews | Semi-structured group interviews were conducted with 7 bPbL and 7 cPbL groups. Entire groups were each interviewed by their PbL tutor ( | PMC9581769 |
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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. Proportion of lecture attendance or use of videos was compared by 2 × 2 contingency tables and Fisher’s exact test. Throughout, | PMC9581769 |
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Results | PMC9581769 |
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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 to the evaluation of CbL scepticism, familiarity with the Internet platform ILIAS, and satisfaction with the course (Fig. Evaluation data of the scales “sceptical about computer-based learning” (CbL), “familiar with the online platform ILIAS” and “satisfied with the course”. For every item, a Likert scale from 1 (= true) to 5 (= not true) was used. Items underlying a respective scale were averaged. Resulting scores from students attending conventional or blended problem-based learning (cPbL or bPbL) are shown as boxplots depicting median, 25th and 75th percentiles. | PMC9581769 |
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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 |
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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 summative exam consisting of 20 single-choice questions (SCQ). Boxplots depict median, 25th and 75th percentiles. cPbL conventional problem-based learning ( | PMC9581769 |
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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 |
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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 university for three quarters of an hour”C3, 47–48: “You just have to be able to be online somehow and then you can also do it from home”I5, 8: “That one can stay at home, i.e. [it is] independent of location”Some statements supporting the blended PbL concerned the C3, 138: “it’s just more comfortable”I4, 8: “During the event you could eat and drink and so on”Some students said that participating via chat allowed them to I7, 78–79: “Because I found just because you have to type it, you think about what you write”Similarly, only students who had participated in bPbL themselves made positive comments with regard to technical aspects.I3, 70–71: “I’m not that tech-savvy myself, but I had no problems with it at all and I liked that” | PMC9581769 |
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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 also just with the discussion, that’s just difficult somehow”I4, 99-102: “Simply because you were reading, then making your own thoughts, then typing, then scrolling up again to see if anyone had already written that, only to realise, oh crap, someone has already written that, I’ll delete it now, rewrite it again”Related to this, one cPbL student suspected that there would often be C5, 33–36: “then maybe someone else has already written this and then you have just written this”I6, 131-133: “Because that was really the case yesterday, that there was really double and triple any content, i.e. the same content”With respect to C6, 66: “Technical problems, if something is not working”Some comments on technical aspects also had a socio-economic facet.C9, 53-55: “There are also disadvantages regarding the person who may not have the financial means to equip themselves technically to be able to participate well”I8, 190–191: “Is it even possible to assume that everyone has a laptop?”Time saving was a frequent argument in favour of the bPbL (see above), whereby this mainly referred to the elimination of the need to travel. On the other hand, there were fears and experiences that communicating by writing in the chat is associated with C3, 19-20: “No, I would be totally lost there, because I just need so long to write until I’ve said my opinion, they’re already on to the next topic”I5, 35–36: “which then takes ages until you have actually typed in your message and got it across”Both cPbL and bPbL students often expressed scepticism about the C9, 23-26: “And I also have the impression that you learn that better [on site]. So you often remember things that you have discussed somewhere and then maybe there was some anecdote about it and I can personally remember that better”I5, 41-42: “That you pick up more and are more concentrated when you sit together in the room here than when you sit at home in front of your PC and just read along as a chat”Many comments referred to the (lack of) C4, 91-93: “I think we all agreed that we would also like to have this social aspect, that we should also meet in this PbL”I7, 193-196: “So I also have the feeling that I would learn more if I somehow, simply connected the spoken word with a person, somehow just this interaction and the personal contact with them”Similarly, concerns that students’ C4, 10–11: “Many then probably also simply hold back with their answers or simply confirm”I9, 29-30: “One is then partly inhibited to write that in there, because one is perhaps not so sure after all” | PMC9581769 |
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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 see it for a long time”Another bPbL student saw the computer-based approach as a good I9, 19–20: “I also thought it was good because it might also introduce us to our future work”Two cPbL students emphasised the advantage of C9, 12-23: “So I think it’s super important simply to have eye contact with the group, so that you can see each other”One student—again from a cPbL group—referred to the fact that C6, 18–19: “You also get all the facial expressions and gestures from the others”Two other cPbL students pointed out that on site, but not in the chat, there is the possibility of C5, 67-68: “Yes, also has the advantage when you meet is that you can then record something like on a whiteboard or so” | PMC9581769 |
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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, additional learning time and exam results. However, there was an effect on attending lectures on site or watching lecture videos. As expected, group interviews revealed that advantages of blended PbL are mainly seen in the free choice of location and time savings. However, there are also interesting differences between the assessments by bPbL and cPbL students.According to Verstegen et al., e-learning approaches in PbL can be used to support contextual learning and/or collaborative learning (Verstegen et al. Compared to the cPbL students, relatively more students in the bPbL groups stated that they had not attended a single lecture on site. This was not necessarily to be expected, as the second PbL meeting, which was held on site for everyone, was immediately preceded by a lecture as part of the course, and events from other courses were also held on site. It is also interesting to note that participants in the conventional PbL were less likely to watch lecture videos, although the advantages were the same (e.g. timing at will, interruption possible at any time, repeated viewing possible). It is tempting to speculate that it was the blended PbL approach that first drew students’ attention to the benefits of further e-learning offers.The results from the group interviews show that limitations in communicating and the lack of personal contact are seen as major shortcomings of our blended PbL approach. Furthermore, there were fears that the learning effect would be lower. However, this disadvantage does not seem to be serious, as shown by the non-different exam results on the one hand and the comparable satisfaction with the course on the other. Although the frequency of statements made in interviews should be interpreted cautiously, it is noticeable that students who had not participated in blended PbL themselves expressed concerns more frequently with regard to the lack of personal contact. That bPbL students raised this concern less often indicates that this disadvantage, too, was actually rather not that serious. On the other hand, bPbL students obviously experienced drawbacks that cPbL students tended not to be concerned about. For example, some bPbL students found communication via chat rather time-consuming and pointed out more often that statements in chat can be repetitive. In summary, our interview data largely confirms the evaluation data. Mostly similar advantages and disadvantages were expected or observed from cPbL or bPbL students, which fits with the similar attitude towards CbL in the evaluation. The fact that students who participated in blended PbL did not describe any serious disadvantages in the interviews fits with the similar course satisfaction in the evaluation by cPbL and bPbL students.Using e-learning approaches for PbL is not new (Bridges et al. | 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 behaviour, or the learning goals derived from group discussions. This should be addressed in future studies. One should be very careful with interpreting findings from qualitative analyses in a (semi-) quantitative manner. Therefore, we have of course only described these results and not analysed them statistically. The results of a single-choice exam only partially reflect the learning success in PbL (Davis and Harden | PMC9581769 |
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Acknowledgements | We thank the students for participating in the study and some colleagues for moderating online groups and/or interviewing the students. | PMC9581769 |
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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 |
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Funding | Open Access funding enabled and organized by Projekt DEAL. | PMC9581769 |
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Data availability | The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request. | PMC9581769 |
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Declarations | PMC9581769 |
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Conflict of interest | The authors declare no competing interests. | PMC9581769 |
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Ethics approval | This study was approved by the Ethics Committee of the Medical Faculty of the University of Cologne (ID: 18–106). | PMC9581769 |
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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 data” and “data concerning my studies (e.g. study duration, exam results)”). Filling in questionnaires as well as participating in interviews was totally voluntary; thus, it was seen as consent to participate, too. | PMC9581769 |
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Consent for publication | Not applicable. | PMC9581769 |
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References | PMC9581769 |
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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 cognitive decline. This study investigated the impact of training frequency on cognitive outcomes after combined physical and cognitive training for older adults with cognitive decline. | PMC9926662 |
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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. Outcome measures were the Montreal Cognitive Assessment, Word List subtest of the Wechsler Memory Scale, Digit Symbol Substitution Test (DSST), and Stroop Color Word Test. | PMC9926662 |
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Results | The HF group demonstrated greater improvement in immediate memory measured by the WL-IM ( | PMC9926662 |
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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 intervention purposes for the elderly with cognitive decline. | PMC9926662 |
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Trial registration | ClinicalTrials.gov Identifier NCT03619577 (08/08/2018). | PMC9926662 |
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Keywords | PMC9926662 |
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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) investigated how the training characteristics of combined cognitive and physical training influenced cognitive performance for community-based older adults. They investigated the effects of different session length (≤ 1 h vs. > 1 h), duration (≥ 16 weeks vs. < 16 weeks), and training frequency (< 5 sessions/week vs. ≥ 5 sessions/week) on cognitive function. They found that the session length and duration did not affect cognitive performance; however, the training frequency did influence the cognitive effects of combined training [Systematic reviews and meta-analyses of effects of combined cognitive and physical training have reported analyses of frequency impacts. These review studies reported that older adults who received a lower frequency (1–2 sessions/week) of combined training had better cognitive performance, denoted by the magnitude of the effect size, than those who received a higher frequency (3–5 sessions/week) [The training frequency may affect cognitive skill acquisition [Contradictory to the previous review studies and skill acquisition theory discussed above, Gheysen et al. (2018), conducting the potential moderator analysis of the efficacy of a combined physical and cognitive intervention, found frequency (≥ 3 vs. 1 session/week) did not significantly influence the effects of combined training on cognition. Although the findings of Gheysen et al. did not favor low-frequency training, there was a trend that the effect size in the low-frequency training was higher than in the high-frequency training. High-frequency training might lead to more effective short-term learning than low-frequency training [No empirical studies to date have directly compared how different frequencies of combined physical and cognitive training affect cognitive function for older adults with cognitive decline. It is critical to search for the precise amount of training that is sufficient, but not overwhelming, to alleviate cognitive decline and enhance cognitive function for older adults with cognitive decline. This study investigated the impact of training frequency on cognitive outcomes after combined physical and cognitive training for older adults with cognitive decline. We hypothesized that combined physical and cognitive training at different frequencies may lead to benefits on different cognitive functions in older adults with cognitive decline. | PMC9926662 |
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Method | PMC9926662 |
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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 (≥ 17 points on the Mini-Mental State Examination), (4) < 26 points on the Montreal Cognitive Assessment (MoCA), (5) no difficulty with basic activities of daily living, and (6) no diagnosis with dementia by a neurologist. Participants were excluded if they had recent myocardial infarction, heart failure, recent heart surgery, severe asthma, cognitive decline concomitant with other neurologic disorders, or an unstable medical condition that might prevent them from performing physical exercise or cognitive training. | 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 chose a small number of sessions (3 sessions/week) to avoid fatigue and excessive stress caused by high-frequency training [Flowchart of participant disposition throughout the study | PMC9926662 |
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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 10 min of cool-down. The physical exercise programs involved aerobic exercises, resistance training, and balance training. For aerobic exercise, such as stepping and walking, the target heart rate was set at 40% to 70% of the maximal heart rate. Equipment for resistance and balance training included water bottles, wrist or ankle weights, Thera-Band, and exercise balls. The therapist increased the physical exercise intensity as the participants improved their performance throughout practice.After physical exercise training, the participants took part in 45 to 50 min of cognitive training. In addition to using a computerized cognitive program, BrainHQ (Posit Science Inc., San Francisco, CA, USA) for cognitive training, we designed a PowerPoint presentation with content derived from BrainHQ and incorporating the functional elements. The domains of cognitive training consisted of attention, memory, processing speed, visuospatial skill, and calculation. Participants practiced two or three cognitive domains in each training session. In the memory task, for example, participants were asked to memorize a series of numbers and then say them backward. Each session contained 10 min of warm-up (explaining the task rules and paying attention to the therapist), 30 to 35 min of cognitive training, and 5 min of cool-down (providing home programs and feedback to the tasks). The tasks were adjusted continuously based on the participant’s level of performance. | PMC9926662 |
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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 Adult Intelligence Scale (WAIS), Word List (WL) of the Wechsler Memory Scale–third edition (WMS-III), and the Stroop Color Word Test (SCWT), to assess cognition in older adults.The MoCA is a widely used instrument to evaluate global cognitive function and has good sensitivity for detecting cognitive decline [The DSST, a subtest of WAIS, was used to assess information processing speed [The WL is a subtest of WMS-III that is the commonly used battery for testing working memory [The SCWT is a commonly used measure to assess inhibitory executive function. The SCWT is a sensitive measure to differentiate individuals with and without cognitive decline [ | PMC9926662 |
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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 |
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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 may result in benefits on different cognitive functions in older adults with cognitive decline. These findings are consistent with our hypothesis. The HF group demonstrated greater improvement in immediate memory measured by the WL-IM and in executive function measured by the SCWT than the LF group. Compared with the HF group, the LF group showed a great improvement in delayed memory measured by the WL-DM. Processing speed and global cognitive function increased in both HF and LF groups.The results of this study indicate that improvements in immediate memory were greater after participants received combined training at a high training frequency than after a low training frequency. Immediate memory, a type of short-term memory, is the ability to remember information that has just been presented [Our results are consistent with those of a previous study indicating that high-frequency training may lead to greater improvement of immediate (short-term) memory than long-term memory [The results showed that participants who received combined training at the low-training frequency had better performance in delayed memory (long-term memory) than those who received high-training frequency. It may be because practicing the new skill or activity at a low frequency may give the brain more time to process and consolidate the information that has been learned. Furthermore, the process of long-term memory may take more time, and rehearsing the information could help strengthen the memory trace and improve retention. Consistent with the previous studies, the low-frequency training could allow the participants to have more time to rehearse the skills or strategies they learned and elicit retrieval and reactivation of a memory trace, leading to better memory consolidation and retention [The HF and LF groups both had improvements in processing speed performance and global cognitive function. Global cognitive performance is usually used to screen the cognitive impairments and as the target of an intervention. Processing speed is one of the strongest predictors of age-related cognitive decline and the incidence of dementia [This study may provide evidence and guidance to practitioners that combined physical and cognitive training offering high or low frequency had positive effects on cognitive function for the elderly with cognitive decline. If environmental or personal reasons prevent the elderly with cognitive decline from going out frequently for the training sessions, one training session per week could also enhance cognitive function. Furthermore, different training frequency of combined physical and cognitive training may benefit different cognitive functions for the elderly with cognitive decline. Clinical practitioners could use different frequency training for distinctive intervention purposes. For example, for improving executive function, clinical practitioners could conduct combined physical and cognitive training at a high training frequency.The current study has some limitations. First, although demographic data were similar between the HF and LF groups, the HF group showed better performance of global cognitive function, processing speed, and memory than the LF group at baseline. Thus, there may have been less room for improvement in the HF group after the combined physical and cognitive training. Future studies could adopt a stratified sampling method to avoid or reduce the bias.Second, our results may not be applicable to older adults with a diagnosis of dementia and normal cognitive function. Future studies are needed to recruit participants with different cognitive levels, such as mild dementia or normal cognition, to verify these training effects on the elderly.Third, lack of random assignment of participants to the intervention may have led to differences in baseline characteristics between two groups and affected the results. However, there were no differences in sex, age, educational levels, and the MMSE baseline score between two groups. The demographic and clinical characteristics might not bias the results, and no adjustments for the baseline characteristics were made.Finally, the lack of a nontreatment control group may be considered a limitation. In the absence of a nontreatment control group, we could not control for learning effects that may influence post-training scores. Future studies should include a nontreatment control group that could control for these biases. | PMC9926662 |
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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 different cognitive functions in older adults with cognitive decline. High-frequency training may lead to greater improvements in short-term memory and executive function, whereas low-frequency training may be more effective for improving long-term memory. These findings may assist clinical practitioners in choosing appropriate training frequencies based on various intervention purposes for the elderly with cognitive decline. | PMC9926662 |
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Acknowledgements | We thank all participants who participated in this study. | PMC9926662 |
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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 and approved the final manuscript. | PMC9926662 |
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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 Research Center Program within the Framework of the Higher Education Sprout Project by the Ministry of Education (MOE) in Taiwan (EMRPD1M0411). | PMC9926662 |
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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 |
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Declarations | PMC9926662 |
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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 |
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Consent for publication | Not applicable. | PMC9926662 |
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Competing interests | The authors declare no competing interests. | PMC9926662 |
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References | PMC9926662 |
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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 August 2022 are collected. The baseline data are analyzed and are randomly divided into a combination group (Asthmatic bronchitis (AB) is common in infants and young children and is a respiratory infectious disease caused by mycoplasma pneumoniae, influenza virus, and respiratory syncytial virus [Therefore, appropriate intervention during treatment can better exert the efficacy of nebulization and improve the symptoms of children. The clinical intervention pathway is a holistic nursing program that integrates multiple disciplines, which can have a positive effect on the clinical treatment of children [The rest of this paper is organized as follows: | 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, shortness of breath, chest tightness, and other phenomena associated with AB disease would lead to changes in lung function, thereby affecting the level of lung function. If not intervened in time, it may lead to hypoxemia and pulmonary hypertension and even lead to severe diseases such as respiratory failure [The number of infants and young children with a family history of the risk of AB disease increased [ | 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 treatment cooperation, (3) receive glucocorticoid aerosol therapy, (4) complete clinical data, and (5) the family members of the children are informed about the study and sign the consent form. The exclusion criteria are as follows: (1) children with congenital heart disease, (2) children with immunodeficiency and respiratory failure, (3) children with mental disorders and hearing impairments, and (4) unable to participate in this study throughout.A single group receives clinical interventions as follows: (1) the AB intervention group is set up by professional medical staff to evaluate various indicators of children with AB based on multiparty literature and their own clinical experience. (2) The nursing team members regularly organize knowledge training to consolidate and deepen the content of clinical nursing paths and related treatment methods. At the same time, the team members need to introduce the content and functions of clinical nursing to the families of the children in detail, so as (3) to strengthen the family members' compliance with treatment, provide the corresponding drug care to the child in a timely manner, and, at the same time, inform the family of the child about the knowledge and principles of the drug, instruct the family to pay attention to the relevant precautions, and deal with the adverse reaction in a timely manner and (4) to actively carry out health education and psychological intervention for the families of children, introduce disease-related knowledge, and strengthen family members' understanding of the disease and its intervention effects, thereby reducing family members' negative emotions such as tension and fear and relieving psychological pressure.The combined group is guided by the combined use of knowledge, belief, and action theory based on a single group intervention. The specific contents are as follows. (1) Understand: collect baseline data such as age, gender, and birth status. At the same time, family-related baseline data (occupation, education level, age, etc.) are collected to preliminarily estimate the family's cognition of the disease and understand its exact needs. Relevant knowledge such as disease etiology, clinical signs, intervention measures, and treatment background is determined. At the same time, an on-site demonstration operation is set up, and the medical staff comments on the operation of the family members, encourages the family members to communicate with each other, and solves the family members' questions. (2) Trust: help family members deal with the problems encountered during the intervention, always pay attention to the psychological state of family members, and provide timely guidance to ensure that family members treat the disease with a positive and correct attitude and build confidence in treatment. (3) Action: instruct family members to pay more attention to their children's diet. The diet structure needs to be healthy and scientific, eating more foods rich in vitamins and proteins that are easy to digest and avoiding cold, irritating, and sweet foods. In addition, the ward should be ventilated in time, maintaining a suitable humidity, ensuring the bed supplies should be replaced in time to reduce virus invasion, and paying attention to scientific medication.Observation indicators are as follows:
The clinical efficacy of the research subjects is analyzed. (1) Significantly effective: 2 days after the intervention, the wheezing and pulmonary wheezing are completely relieved. (2) Effective: 7 days after the intervention, the wheezing and pulmonary wheezing are significantly relieved. (3) Ineffective: Seven days after the intervention, the clinical symptoms of the children did not change or even worsened compared with those before the intervention. Treatment effective rate is equal to (marked number + effective number)/total × 100%Analyze the pulmonary function level of the research subjects, including forced expiratory volume in 1 s (FEV1), forced vital capacity (FVC), and the percentage of FEV1 in FVC (FEV1/FVC%)Univariate analysis of the influencing factors of poor prognosis in children with ABBinary logistic regression analysis of risk factors affecting the prognosis of children with ABThe data are unified and entered into SPSS 26.0 software for processing. The measurement data are expressed as mean ± standard deviation ( | PMC9957635 |
4. Pulmonary Function and Univariate Analysis of the Influencing Factors | PMC9957635 |
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4.1. Baseline Data | PMC9957635 |
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4.2. Clinical Efficacy of Research Subjects | PMC9957635 |
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4.3. Pulmonary Function of Subjects before and after Intervention | PMC9957635 |
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4.4. Univariate Analysis of the Influencing Factors of Poor Prognosis in Children with AB | PMC9957635 |
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4.5. Binary Logistic Regression Analysis of Risk Factors Affecting the Prognosis of Children with AB | PMC9957635 |
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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 improve their lung function, and at the same time, it can increase the family members' treatment compliance and enthusiasm, speed up the recovery of children, and improve family members' satisfaction. However, the number of research objects selected in this paper is small and the scope is narrow, and the results may be biased to some extent. Therefore, it is necessary to further increase the number and scope of selected research objects on this basis for further exploration, so as to provide clinical intervention for children with AB. | PMC9957635 |
Data Availability | The simulation experiment data used to support the findings of this study are available from the corresponding author upon request. | PMC9957635 |
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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 research subjects after intervention (Analysis of the pulmonary function indexes of the subjects before the intervention and 1 month and 3 months after the intervention (Influencing factors of poor prognosis in children with AB by univariate analysis (Variable assignment table.Binary logistic regression analysis of risk factors affecting the prognosis of children with AB. | PMC9957635 |
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Key Points | PMC10236240 |
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Question | mucinous appendiceal adenocarcinoma | Is fluoropyrimidine-based systemic chemotherapy effective in treating patients with inoperable low-grade mucinous appendiceal adenocarcinoma? | PMC10236240 |
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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 |
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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 low-grade mucinous appendiceal adenocarcinoma. | 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 |
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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 appendiceal adenocarcinoma, with radiographic imaging demonstrating the presence of mucinous peritoneal carcinomatosis and were not considered candidates for complete cytoreductive surgery. Key exclusion criteria were concurrent or recent investigational therapy, evidence of bowel obstruction, and use of total parenteral nutrition. Data were analyzed from November 2021 to May 2022. | PMC10236240 |
Interventions | Patients were randomized to either 6 months observation followed by 6 months of chemotherapy, or initial chemotherapy followed by observation. | PMC10236240 |
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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 |
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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 first. Most patients (15 patients [63%]) were treated with either fluorouracil or capecitabine as single agent; 3 patients (13%) received doublet chemotherapy (leucovorin calcium [folinic acid], fluorouracil, and oxaliplatin or folinic acid, fluorouracil, and irinotecan hydrochloride), and bevacizumab was added to cytotoxic chemotherapy for 5 patients (21%). Fifteen patients were available to evaluate the primary end point of difference in tumor growth during treatment and observation periods. Tumor growth while receiving chemotherapy increased 8.4% (95% CI, 1.5% to 15.3%) from baseline but was not significantly different than tumor growth during observation (4.0%; 95% CI, −0.1% to 8.0%; | 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 difference in the rate of tumor growth while receiving chemotherapy. | PMC10236240 |
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Trial Registration | ClinicalTrials.gov Identifier: | PMC10236240 |
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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 infiltrating, margins.In nearly all patients, metastatic spread of AA is limited to the peritoneal cavity, causing the clinical syndrome pseudomyxoma peritonei (PMP). | 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 surface malignancy surgeons at MDACC, in coordination with our multidisciplinary peritoneal surface malignancy conference. Criteria for determining nonresectability were: medical comorbidities presenting high surgical risk; tumor bulk and location, such as encasement of the liver hilum or extensive small bowel involvement that would preclude the possibility of obtaining a complete cytoreduction (completeness of cytoreduction score of 0 or 1); or prior CRS that was unsuccessful. Patients were required to have Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2, be aged at least 18 years, and have adequate bone marrow function (hemoglobin, ≥9.0 g/dL [to convert to grams per liter, multiply by 10]; platelets, ≥75 cells × 10 | 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 |
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Participant Recruitment Flowchart | Total study duration was 12 months. CT indicates computed tomography. | PMC10236240 |
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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 cystic lesions are allowed) in the peritoneal cavity in contrast to the maximum of 2 lesions, per standard RECIST. A computed tomography scan of the abdomen and pelvis was performed at baseline and every 3 months as standard of care. Tumor markers (carcinoembryonic antigen [CEA], cancer antigen 125 [CA125], and CA19-9) were measured in peripheral blood collected at baseline and 3, 6, 9, and 12 months. All patients with available 3-, 6-, 9-, or 12-month data were combined to compare percentage change in each marker level between the observation and treatment periods. Additional secondary efficacy end points were the objective response rate, the rate of bowel complications (defined as bowel obstruction requiring hospitalization or bowel perforation), and differences in OS between early and delayed chemotherapy approaches. Safety monitoring was conducted for the composite safety end point of death or bowel complication. | 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 EORTC QOL questionnaire (EORTC QLQ-OV28), due to the considerable similarity in symptoms of peritoneal disseminated disease from ovarian cancer, and the anxiety-specific Speilberger State/Trait Anxiety Inventory State (STAI) scale. | 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 data, a 7.4% (95% CI, 3.0%-11.7%) effect size was observed. The SD of residuals was 3.5% for the random effects introduced by the 2 readers. Considering both the variation introduced by different readers and variation of the treatment effects, the combined SD of differences was 4.1%. Based on these preliminary data, we deemed a difference of at least 5% in mpRECIST-determined tumor size change to be clinically meaningful. Assuming a crossover analysis of variance square root of mean square error of 4.0% and a 1-sided α = .05, it was estimated that 24 patients would provide 80% power to detect a 5% difference; enrollment of up to 30 patients was planned to have complete 6- and 12-month tumor measures for 24 patients.Crossover analyses were performed according to Senn methods.A safety monitoring rule was in place to stop the trial early if a Fisher exact test ever detected a difference between the treatment and observation period in this composite measure that was ever significant at the α = .05 level. OS was estimated in each group and graphed by Kaplan-Meier methods. Comparison between the treatment first and observation first groups was performed with a log-rank test. Kaplan-Meier curves were implemented in Stata statistical software version 16 (StataCorp). All other analyses were performed in SAS statistical software version 9.4 (SAS Institute). Data were analyzed from November 2021 to May 2022. | PMC10236240 |
Results | PMC10236240 |
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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 were randomized to observation first. Most patients (20 patients [83%]) had well-differentiated tumors, and 4 patients (17%) had well-to-moderately differentiated tumors. Pathological diagnosis was confirmed by a pathologist with specific expertise in appendiceal cancer, and graded using a 3-tiered system evaluating tumor cellularity, destructive invasion, presence of signet ring cells, as well as complexity of tumor architecture | 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 |
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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 95.5) months, and there was no significant difference in OS between the observation-first group (76.0 [8.6 to 95.5] months) and the treatment-first group (53.2 [8.1 to 64.1] months; hazard ratio [HR], 0.64; 95% CI, 0.16 to 2.6; | PMC10236240 |
Kaplan-Meier Curves Showing Overall Survival of All Patients and Between Groups | Crosses indicate censoring. | PMC10236240 |
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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 |
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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 life while receiving chemotherapy ( | PMC10236240 |
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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, it has been difficult to objectively determine whether systemic chemotherapy is effective in the treatment of this disease. This study represents the first prospective, randomized trial for low-grade mucinous AA to answer this pivotal question, to our knowledge. Moreover, chemotherapy significantly decreased QOL during the chemotherapy period compared with the observation period. Similarly, delaying the start of chemotherapy with a 6-month observation period did not reduce OS nor increase rate of bowel perforation or obstruction.The results from this prospective, randomized trial are consistent with multiple prior retrospective analyses suggesting chemotherapy is ineffective in low-grade AA.To our knowledge there are no reports of objective response from cytotoxic systemic chemotherapy specifically in low-grade AA. It is important to note that this is in contrast to high-grade AA, which is known to be responsive to cytotoxic chemotherapy on the basis of many prior reports. | PMC10236240 |
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