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Background | lung cancer, airway obstruction | LUNG CANCER, AIRWAY OBSTRUCTION | Acapella plus active cycle of breathing technique (ACBT), external diaphragm pacemaker (EDP) plus ACBT have been shown to facilitate the recovery of functional capacity and lung function in patients suffering from airway obstruction but the efficacy in perioperative patients with lung cancer has not been proven. | PMC10053339 |
Methods | lung cancer | LUNG CANCER | We conducted a three-arm, prospective, randomized, assessor-blinded, controlled trial in patients with lung cancer who underwent thoracoscopic lobectomy or segmentectomy in the department of thoracic surgery, China. Patients were randomly assigned (1:1:1) to receive Acapella plus ACBT, EDP plus ACBT, or ACBT group (control group) using SAS software. The primary outcome was functional capacity, measured by the 6-minute walk test (6MWT). | PMC10053339 |
Results | We recruited 363 participants over 17 months: 123 assigned to the Acapella plus ACBT group, 119 to the EDP plus ACBT group, and 121 to the ACBT group. Statistically significant differences were noted for functional capacity between the EDP plus ACBT and control groups at each follow-up time (1-week follow-up: difference = 47.25 m, 95% CI, 31.56–62.93; | PMC10053339 |
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Conclusion | lung cancer | LUNG CANCER | EDP plus ACBT and Acapella plus ACBT significantly improved functional capacity and lung function in perioperative patients with lung cancer, compared with single-model ACBT, and the effects of EDP plus ACBT were clearly superior to those of other programs. | PMC10053339 |
Trial registration | The study was registered in the clinical trial database (clinicaltrials.gov) on June 4, 2021 (No. NCT04914624). | PMC10053339 |
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Supplementary Information | The online version contains supplementary material available at 10.1186/s12885-023-10750-4. | PMC10053339 |
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Keywords | PMC10053339 |
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Background | cancers, cancer, stroke, lung cancer, deaths | CANCERS, POSITIVE, CANCER, STROKE, LUNG CANCER | As a major public health issue worldwide, lung cancer is the second most commonly diagnosed cancer, accounting for approximately 11.7% of all diagnosed cancers, and is the predominant cause of cancer-induced mortality (approximately 1.8 million deaths) [The active cycle of breathing technique (ACBT) is an ACT that focuses on the patients controlling their breathing pattern and includes breathing control, 3–4 thoracic expansion exercises, and a forced expiratory technique (huffing) [Acapella® (DHD Healthcare, Wampsville, NY, USA; CE approved) is a novel portable ACT for airway clearance that applies positive expiratory pressure with dual actions of pressurised respiration and vibration. Positive expiratory pressure encourages airflow behind secretions and alters sputum rheology (mucus flow), which facilitates secretion clearance without over-inflating the lungs [External diaphragm pacemaker (EDP, manufactured by Guangzhou Arahelio Biotechnology Co., Ltd., model HLO-GJI3A) stimulates the phrenic nerve through body surface low-frequency pulse electrical stimulation to increase phrenic nerve excitability, phrenic muscle contractility, and diaphragmatic activity, thus achieving the purpose of increasing the effective ventilation volume of alveoli and promoting the rehabilitation of functional capacity. Increasing evidence has suggested that EDP combined with ACBT is beneficial for reducing PPCs in patients with stroke [To quantify the effects of Acapella plus ACBT or EDP plus ACBT on functional capacity, lung function, and PPCs in postoperative patients with lung cancer, a three-arm, prospective, randomised, assessor-blinded, controlled trial was conducted. The objectives of this study were to (1) determine the efficacy of Acapella plus ACBT or EDP plus ACBT in promoting the rehabilitation of functional capacity, lung function, and PPCs compared with single-model ACBT; and (2) affirm whether one program is superior to the others. | PMC10053339 |
Methods | PMC10053339 |
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Study design and setting | lung cancer | LUNG CANCER | This randomised (1:1:1), assessor-blinded, controlled trial compared three parallel groups of patients with lung cancer who underwent surgical resection. This study was approved by the Ethics Committee of the hospital, under reference number B2020-173-01, and submitted to the clinical trial database (clinicaltrials.gov; registration number: NCT04914624) on 04/06/2021. All procedures in this study were conducted in accordance with the principles of the Declaration of Helsinki. | PMC10053339 |
Participants | lung cancer, non-small cell lung carcinoma, cognitive impairment | LUNG CANCER, THORACIC, NON-SMALL CELL LUNG CARCINOMA, MOTOR DISORDERS | The participants were patients with lung cancer admitted to the Department of Thoracic Surgery in China. Patients were included if they (1) were aged between 18 and 80 years, (2) were diagnosed with stage I to IIIA non-small cell lung carcinoma subtypes by pathological cytology, (3) were undergoing thoracoscopic lobectomy or segmentectomy, (4) had no history of mental illness and cognitive impairment, (5) had no motor disorders of the limbs and motor contraindications, (6) had a predicted percentage of forced expiratory volume in the first second (FEV1% of predicted) at admission ≥ 80% [ | PMC10053339 |
Randomisation and blinding | Participants who satisfied the eligibility criteria were block randomised using SAS software (version 9.4; SAS Institute, Inc.) with a 1:1:1 allocation using random block sizes of 3 and 6. Patients were equally assigned to the Acapella plus ACBT, EDP plus ACBT, or ACBT group. Blinding of participants to the treatment allocation was not possible or desirable, and outcome measures were assessed blindly by investigators who were blinded to the group to which each participant was allocated.In this study, both research investigators and surgeons verified eligibility. Upon establishing the indication for surgery, a medical research team screened the patients to determine whether they had any health-related conditions that prevented them from participating in the trial. The research investigators then contacted them and arranged an appointment to explain the trial in detail during the scheduled outpatient appointment. Sufficient time was given to patients to inquire about the trial details and decide whether to participate. After written informed consent was obtained following a complete explanation of the study, a multidisciplinary assessment was conducted by physiotherapists, surgeons, and rehabilitation nurses with extensive experience in implementing pulmonary rehabilitation and using these therapies. | PMC10053339 |
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Intervention | After enrolment, patients in all groups participated in a multidisciplinary conventional inpatient rehabilitation program on the day of admission and day before surgery, and the program was standardised using evidence from systematic reviews and mainly included exercise, education, nutritional, respiratory physiotherapy, and psychological counselling [ | PMC10053339 |
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Control group | During the control period, participants underwent ACBT treatment, which was standardised using evidence from systematic reviews, comprising 3–5 breath controls, 3–4 thoracic expansion exercises, and 2–3 forced expiratory techniques [
CONSORT 2010 flow diagram for the trialNote: | PMC10053339 |
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Intervention group | Participants in the Acapella plus ACBT intervention group received a five-session combined ACTs program targeted at facilitating airway clearance on the day of admission, day before surgery, and POD 1–3 in the ward. Initially, the participants were asked to maintain a semi-recumbent position with the abdomen relaxed in a hospital bed, perform 3–4 thoracic expansion exercises with active inspiration, exhale through the Acapella device (frequency/resistance dial set gradually starting from the minimum setting to the maximum setting participants could tolerate) in a 4–6-second timeframe, and control breathing, with eight repetitions of the whole process. Finally, the participants performed the forced expiratory technique (huffing) to clear their airways. Once the participants had been treated for a maximum of 30 min, no longer expectorated sputum, or were too fatigued to continue, the treatment was considered as complete.In the Acapella plus EDP intervention, all participants and caregivers were instructed by the rehabilitation team on the necessary precautions and received a booklet with detailed instructions. The ACBT procedure in this group was consistent with that in the control group. All patients assumed the supine position, cleaned their neck and chest, and removed surface sebum and sweat before the intervention. The participants underwent EDP treatment, which was provided by physiotherapists, at a pacing frequency of 15 times per minute, pulse frequency of 40 Hz, and stimulation intensities gradually starting from 40 Hz to the intensities that participants could tolerate. Two pairs of electrode sheets were attached by the physiotherapists to the skin at the second intercostal space along the middle clavicular line and the distal one-third of the outer edge of the sternocleidomastoid muscles. The treatment, lasting an average of 30 min, was implemented on the day of admission, day before surgery, and POD 1–3 in the ward. | PMC10053339 |
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Outcomes | lung cancer, cancer | LUNG CANCER, CANCER, SECONDARY | The primary outcome was functional capacity in patients with lung cancer, as measured by the 6-minute walk test (6MWT), 1 week preoperatively and 1 month postoperatively. The 6MWT is a standardised test used to predict the prognosis of functional capacity in adult and geriatric patients with cancer [The secondary outcome measures were lung function parameters, PPCs, drainage tube removal time, and postoperative hospital stay in patients with lung cancer. Currently, lung function evaluation in clinical practice comprises forced vital capacity (FVC) and FEV1 [ | PMC10053339 |
Statistical analysis | bleeding | SECONDARY, PATHOLOGY, BLEEDING | In this study, PASS 14 (PASS software, Kaysville, Utah, USA; All analyses were conducted in accordance with the intention-to-treat principle. Continuous variables are expressed as mean (SDs), and categorical variables as frequencies and percentages. Descriptive statistics were used for baseline characteristics and outcomes. Group differences at baseline were reported using one-way analysis of variance, chi-square (χ2) test, or nonparametric test, as appropriate, and the 95% confidence interval (CI) was calculated. Due to the prespecified sequence of rehabilitation training comparisons (ACBT vs. Acapella plus ACBT, ACBT vs. EDP plus ACBT, Acapella plus ACBT vs. EDP plus ACBT; results were interpreted as if from three independent trials, with interpretation for one comparison independent of the outcome of another), no adjustment for multiple comparisons was performed in the study.For primary and secondary outcome analyses, repeated-measures linear mixed models (LMMs) were conducted to assess the intervention effects. The main effects of group and time and interaction effects between group and time were examined in the LMMs using repeated measurements of the groups at baseline and the two follow-up points (i.e., at the 1-week and 1-month follow-ups), adjusting for baseline demographic and disease-related characteristics (i.e. age, sex, height, weight, education level, smoking amount, smoking years, pathology typing, type of procedure, operative time, anaesthesia time, and bleeding volume) and baseline outcomes of functional capacity and lung function parameters. The R package nlme was used to conduct the LMM analysis. In addition, the R packages ggplot2 (version 3.3.5) and ggprism (version 1.0.3) were used to draw line charts. PPCs were listed by group. The total incidence of PPCs, drainage tube removal time and postoperative hospital stay were compared using the Kruskal-Wallis test. All analyses were conducted using the R software (version 4.1.2). | PMC10053339 |
Results | PMC10053339 |
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Participant characteristic | lung cancer | LUNG CANCER | Between July 1, 2021, and November 31, 2022, 400 patients with lung cancer were enrolled in the study, and 35 were subsequently excluded because they did not meet the eligibility criteria. Therefore, 365 patients with lung cancer were randomised into groups. Two patients dropped out due to withdrawal of consent, resulting in a dropout rate of 0.5%. According to the intention-to-treat principle, 121 participants in the ACBT group, 123 in the Acapella plus ACBT group, and 119 in the EDP plus ACBT group were finally included in the analysis. The flow of participant enrolment is shown in Fig.
Baseline characteristics of participantNote: | PMC10053339 |
Outcomes | bleeding | BLEEDING, PATHOLOGY | Table
Effects of the intervention on 6-minute walk test and lung function parametersǂ: Between-group difference for mean change, based on the linear mixed model, adjusted for baseline demographic and disease-related characteristics (i.e. age, sex, height, weight, education level, smoking amount, smoking years, pathology typing, type of procedure, operative time, anaesthesia time, and bleeding volume), and baseline outcomes of functional capacity and lung function parameters, and id as a random effecta: Not applicable | PMC10053339 |
Primary study endpoint | At the 1-week follow-up after surgery, the 6MWT of participants was significantly improved in the EDP plus ACBT (difference = 47.25 m; 95% CI, 31.56–62.93;
(A) 6-minute walk test, (B) the predicted percentage of forced expiratory volume in the first secondData points indicate means and error bars represent 95% confidence intervals.Note ACBT = active cycle of breathing technique; EDP = external diaphragm pacemaker; FEV1 = forced expiratory volume in one second; % of predicted = the predicted percentage. | PMC10053339 |
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Secondary study endpoint | lung cancer, Postoperative pulmonary complications, atelectasis, hypoxemia | LUNG CANCER, SECONDARY, ATELECTASIS, PULMONARY INFECTION | Compared with the control group, participants in the Acapella plus ACBT group had significantly improved FEV1% of predicted at the 1-week (difference = 13.35; 95% CI, 9.83–16.87; Among the remaining lung function parameters, between-group differences in the FVC% of predicted followed a similar pattern to FEV1% of predicted; FVC% of predicted significantly improved in the Acapella plus ACBT (1-week follow-up: difference = 14.00, 95% CI, 10.39–17.6; Another secondary outcome in this study was the incidence of PPCs in patients with lung cancer, including pulmonary infection, hypoxemia, and atelectasis. In total, 54 (14.88%) of the 363 participants were diagnosed with PPCs, including 28 (23.14%) of 121 in the control group, 16 (13.01%) of 123 in the Acapella plus ACBT group, and 10 (8.40%) of the 119 in the EDP plus ACBT group (Table
Postoperative pulmonary complications, the drainage tube removal time and postoperative hospital staysa: Not applicable.Note: ACBT = active cycle of breathing technique; EDP = external diaphragm pacer; n = number; hrs = hours. | PMC10053339 |
Discussion | lung cancer, pain, non-cystic fibrosis bronchiectasis, trauma | LUNG CANCER, NON-CYSTIC FIBROSIS BRONCHIECTASIS | To our knowledge, the present trial is the first to directly compare two combined ACT programs comprising Acapella plus ACBT and EDP plus ACBT, both with one another and with the single-model ACBT program. The results support the hypothesis that preparing perioperative patients for surgical resection of lung cancer with the combined ACTs programs leads to a better functional capacity and lung function after pulmonary surgery compared with the single ACBT program; additionally, the combined ACT programs were safe and effective therapies for the rehabilitation of perioperative patients with lung cancer.Compared with ACBT, both combined ACT programs significantly improved the 6MWT distance over the 1-week and 1-month postoperative follow-up period. Our finding of short-term improvement in the 6MWT distance is consistent with that reported previously. One study observed a significant improvement in the functional capacity for patients with non-cystic fibrosis bronchiectasis following ACT combined with exercise training, with a mean change (95% CI) in 6MWD of 41 m (95% CI, 19–63) compared with the control group (All three groups in this study showed a reduction in FEV1% of predicted after surgery. In line with our findings, a previous study showed that lung function parameters did not return to baseline levels, possibly because of surgical trauma, wound-related pain, and indwelling of the chest tube [The improvement in FEV1% of predicted in the combined EDP plus ACBT group was significantly better than that in the other groups at both follow-up period. With longer-term follow-ups, an upward trend may persist in the EDP plus ACBT group, which can be explained by the timing of intervention delivery. The study has examined the main effects of group and time and interaction effects between group and time, and the findings of the primary analysis would not be altered. The results of this trial affirmed findings from a previous study, indicating that perioperative patients with lung cancer benefit from EDP plus ACBT with improved lung function [In this study, EDP plus ACBT favoured longer walking distances than did the other two therapies. In contrast, a previous study reported no significant difference in the 6MWT distance between breathing training using ACBT (n = 15) and that assisted by EDP plus ACBT (n = 15), which may have resulted from the small sample size [The incidence rate of PPCs has been estimated to be 15–59% in patients who have undergone lung cancer surgery, which is consistent with the results of this study [ | PMC10053339 |
Limitations | BLIND | The main limitation of this study was the inability to blind the patients and therapists with regard to treatment allocation; therefore, potential performance bias might have been generated. Our study attempted to reduce the possibility of detection bias, including having assessors of outcomes blind to group allocations. Another limitation is that the baseline 6MWT distances of patients in all groups were > 450 m; therefore, further studies are warranted to explore and investigate the effects of combined ACT programs in the population involving patients walking < 450 m at baseline. The final limitation of this study was its relatively short follow-up period for more analyses of outcomes beyond the 1-month follow-up. Additionally, the long-term effect of the combined ACT program requires further investigation. | PMC10053339 |
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Conclusions | lung cancer | LUNG CANCER | This study found that EDP plus ACBT and Acapella plus ACBT significantly improved functional capacity and lung function in perioperative patients with lung cancer, compared with single-model ACBT, and the effects of EDP plus ACBT were superior to those of Acapella plus ACBT. Thus, both combined ACT programs are effective. These findings encourage healthcare providers to implement combined ACT programs, especially EDP plus ACBT, as part of routine perioperative care. | PMC10053339 |
Acknowledgements | We express our sincere appreciation to all patients, caregivers, and healthcare providers who participated in this study. | PMC10053339 |
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Author Contribution | Chuanzhen Li | Jiudi Zhong, Hao Long, and Zhixing Guo conceived and drafted the protocol for this study and raised funds. Xiaoxue Chen, Chuanzhen Li, and Linjuan Zeng designed and performed experiments. Qinglin Wang, Tiehua Rong, and Peng Lin analysed the study data and prepared the figures. Xiaoxue Chen, Chuanzhen Li, and Linjuan Zeng wrote the manuscript. Jiudi Zhong, Hao Long, and Zhixing Guo revised the manuscript. Xiaoxue Chen, Chuanzhen Li, and Linjuan Zeng are the first authors. Jiudi Zhong, Hao Long, and Zhixing Guo were the people ultimately responsible for the study. The final manuscript was reviewed and approved by all the authors. | PMC10053339 |
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Funding | -11 | This project was supported by a grant from the Wu Jieping Medical Foundation, China (Grant/Award Number:320.6750.2020-15-11). | PMC10053339 |
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Data Availability | The datasets used and/or analysed during the current study are available from the corresponding author on request. | PMC10053339 |
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Declarations | The authors declare no competing interests. | PMC10053339 |
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Ethics approval and consent to participate | ONCOLOGY | The study was approved by the Ethics Committee of the Oncology Center of Sun Yat-sen University on July 28, 2020 (B2020-173-01), and all methods were carried out in accordance with the Declaration of Helsinki. All patients participating in the study voluntarily signed the informed consent form in person. | PMC10053339 |
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Consent for publication | Not applicable. | PMC10053339 |
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Competing interests | All authors of this study stated that they had no conflict of interest. | PMC10053339 |
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Abbreviations | Postoperative pulmonary complicationsAirway clearance techniquesActive cycle of breathing techniqueExternal diaphragm pacemakerForced expiratory volume in the first secondPostoperative days6-minute walk testPostoperative daysStandard deviationConfidence intervalLinear mixed model | PMC10053339 |
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References | PMC10053339 |
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Keywords | weight loss | To elucidate the role of neighborhood walkability and crime on weight loss, we examined data from older adults residing in Chicago who participated in a randomized controlled trial lifestyle intervention. Controlling for individual demographic characteristics and the intervention assignment, the neighborhood homicide rate was significantly associated with weight change. Participants who resided in neighborhoods above the 50th percentile of homicide rate actually gained weight between pre- and post-intervention. On the other hand, there was no significant relationship between the level of walkability and weight loss. Our findings suggest that the social environment related to neighborhood crime may play a more important role in weight loss than the built environment, such as walkability. Urban characteristics related to walkability, such as sidewalks, may increase physical activity, however, interventions aiming to increase physical activity to promote weight loss will benefit by addressing the neighborhood social environment that determines how people navigate space. | PMC10544679 |
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Introduction | obesity, weight loss | OBESITY, DISEASE | The prevalence of adult obesity with Body Mass Index (BMI) greater than 30 is expected to reach nearly 50% of the United States (U.S.) population by 2030 (Centers for Disease Control and Prevention, Studies have documented the effect of neighborhood social conditions, including social support and cohesion, a sense of community, crime and violence, and informal social control, on how people interact with others and with the environment (Bursik & Grasmick, The built environment may influence individuals’ health by either facilitating or impeding healthy lifestyle behaviors, including adequate physical activity (Barnett et al., Prevalent crime as a component of the built environment, may be a barrier to walkability and physical activity (Gomez et al., Perceptions of neighborhood safety may influence these contradictory findings (Giles-Corti & Donovan, Interestingly, Foster and colleagues (Foster et al., This study aims to elucidate the role of walkability and neighborhood crime on weight loss using data from older Chicago residents participating in a randomized controlled trial (RCT) lifestyle intervention. This original RCT included predominantly Black older adults who lived on the South Side of Chicago, which is highly racially segregated and affected by increased crime. We hypothesized that neighborhood walkability and homicide would have differential effects on participants’ weight loss and physical activity. Specifically, pre- and post-intervention weight loss would be greater for participants living in neighborhoods with high walkability and lower for participants living in neighborhoods with high homicide rates. | PMC10544679 |
Methods | PMC10544679 |
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Setting and data | This analysis utilized data from an RCT, | PMC10544679 |
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Variables and statistical analysis | deaths, Ewing | Of the 185 original study participants, our analysis included 184 participants who resided within Cook County, Illinois. We geocoded participants’ residential addresses using ArcGIS and appended census tract numbers which were used to merge with the neighborhood variables.The outcome variable was weight change between pre- and post-intervention (i.e., weight measurement taken eight months after the intervention). Individual-level measures included age (ranging between 55 and 81 years), sex (female vs. male), race (Black vs. all other groups), income (less than $40,000 vs. $40,000 or more), and education (high school or lower, some college, and college or higher). We also included the level of pre-intervention moderate to vigorous physical activity in minutes per day measured by the ActiGraph wGT3X triaxial accelerometer (Santos-Lozano et al., Two neighborhood exposure variables were developed: walkability and crime. We used the National Walkability Index developed by the U.S. Environmental Protection Agency, which incorporates three indicators: intersection density (design), proximity to transit stops (distance), and mix of employment and household types (diversity) (Ewing & Cervero, Neighborhood crime was measured using homicide incident cases from the Cook County Medical Examiner’s archive, which includes all homicide deaths along with the address of each incident (Cook County Medical Examiner’s Office, | PMC10544679 |
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Discussion | weight gain, weight loss | SAMPSON | Our findings showed that neighborhood crime measured by the homicide rate was significantly associated with less weight loss, controlling for all other variables including the intervention assignment. Participants who resided in neighborhoods at or above the 50th percentile of homicide rate actually gained weight between pre-and post-intervention, regardless of randomization to one of the three intervention arms. On the other hand, the relationship between neighborhood walkability and weight loss was not statistically significant.Current literature suggests that individuals living in high walkability areas tend to be more physically active. High walkability seems to decrease the risk of excessive weight gain (Lovasi et al., Conversely, high-crime neighborhoods are associated with a variety of poor health outcomes (Sampson, Although much of the scientific literature finds that urban communities with high walkability may also have high levels of crime (Foster et al., | PMC10544679 |
Funding | Sage Kim was supported by NIMHD (R01MD014839); Lisa Tussing-Humphrys was supported by NIMHD (U54MD012523; Marian Fitzgibbon was supported by NHLBI (R01HL129153); Caryn Peterson was supported by NCI (U54CA202995; U54CA202997). | PMC10544679 |
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Declarations | PMC10544679 |
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Conflicts of interest/Competing interests | None. | PMC10544679 |
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References | PMC10544679 |
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Abstract | PMC10757118 |
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Background | Approximately 40% of patients with hormone receptor (HR)‐positive and human epidermal growth factor receptor 2 (HER2)‐negative advanced breast cancer (ABC) exhibit PIK3CA mutations. | PMC10757118 |
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Aims | This study aims to evaluate the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of HS‐10352, a selective PI3Kα inhibitor, in this patient population. | PMC10757118 |
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Materials and Methods | toxicity | Conducted as a phase 1 dose‐escalation trial, HS‐10352 was administered orally once‐daily (QD) at dose levels of 2, 4, 6, and 8 mg. The primary endpoints were dose‐limiting toxicity (DLT) and the maximum tolerated dose (MTD). This study is registered at ClinicalTrials.gov (NCT04631835). | PMC10757118 |
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Results | hyperglycemia, weight loss, mutated tumors, SD | HYPERGLYCEMIA, DISEASE, ADVERSE EVENTS | Between August 2020 and March 2022, a total of 18 female patients were enrolled. DLT, manifested as hyperglycemia, occurred in two patients in the 8 mg QD group, establishing an MTD of 6 mg QD. The most common treatment‐related adverse events were hyperglycemia (88.9%) and weight loss (61.3%). In the 6 mg QD group, four patients (66.7%) had a partial response (PR), and one (16.7%) had stable disease (SD). Among the four patients with PIK3CA mutated tumors in this dosage group, three (75.0%) had PR and one (25.0%) had SD. The median progression‐free survival was not reached (95% confidence interval, 11.1‐NA). | PMC10757118 |
Discussion and Conclusion | cancer tumor, mutated tumors | PROLIFERATION, METASTATIC BREAST CANCER | HS‐10352 at 6 mg QD was well‐tolerated in patients with HR‐positive, HER2‐negative ABC, and showed preliminary antitumor activity in patients with PIK3CA mutated tumors. These findings support the further clinical development of HS‐10352.HS‐10352 is a novel selective PI3Kα inhibitor showing inhibitory effects on the proliferation of cancer tumor cell lines harboring PIK3CA mutations. This study first evaluated the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of HS‐10352 in patients with HR‐positive, HER2‐negative metastatic breast cancer. The results support further clinical development of HS‐10352.
| PMC10757118 |
INTRODUCTION | breast cancer, cancer, Breast cancer, gastric cancer HGC‐27, human gastric cancer, deaths, tumors, weight loss | BREAST CANCER, PROLIFERATION, CANCER, BREAST CANCER, TUMOR GROWTH, TUMORS | Breast cancer is the most common cancer and the leading cause of cancer‐related deaths in females.HS‐10352 is a novel, highly selective PI3Kα inhibitor with an IC50 value of 0.34 nM. It exhibits far greater selectivity for PI3Kα over PI3Kβ, PI3Kδ, and PI3Kγ, with 321‐, 103‐, and 159‐fold higher selectivity, respectively. This heightened selectivity may help minimize the severe side effects commonly associated with the inhibition of PI3Kβ, δ, and γ. Preclinical studies, both in vitro and in vivo, have demonstrated that HS‐10352 effectively inhibits PIK3CA mutations. For instance, HS‐10352 substantially inhibited the proliferation of human breast cancer cell lines harboring PIK3CA mutations, such as HCC1954 and MCF‐7, in vitro assays. Conversely, HS‐10352 displayed no inhibitory effects on cell lines lacking PIK3CA mutations, like the human breast cancer HDQ‐P1 cell line and the human gastric cancer SNU‐1 and MKN‐74 cell lines. In animal models, HS‐10352 markedly suppressed the growth of transplanted tumors in a dose‐dependent manner in mice bearing gastric cancer HGC‐27 (PIK3CA E542K) and human breast cancer HCC‐1954 (PIK3CA H1047R) tumors. Specifically, in mice with HCC‐1954 tumors, oral treatment with HS‐10352 at 10 mg/kg once‐daily (QD) for 21 days resulted in a 124.47% inhibition in tumor growth without causing significant weight loss.This study aimed to evaluate the safety, tolerability, pharmacokinetics, and preliminary antitumor efficacy of oral HS‐10352 in patients with HR‐positive, HER2‐negative ABC. | PMC10757118 |
METHODS | PMC10757118 |
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Study design and patients | Tumors, diabetes symptoms, primary malignant tumors, diabetes | BRAIN METASTASES, DISEASES, SPINAL CORD COMPRESSION, TUMORS, CHRONIC PANCREATITIS, METASTASES, DIABETES | This was an open‐label, phase 1 dose‐escalation trial registered at Key inclusion criteria were as follows: (1) 18–75 years of age; (2) at least one measurable lesion according to Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1Key exclusion criteria were as follows: (1) previous treatment with PI3K, AKT, or mTOR inhibitors before enrollment; (2) previous treatment with potent CYP3A4 and/or CYP2C8 inhibitors or inducers within 7 days before enrollment; (3) unstable, untreated or newly onset brain metastases, spinal cord compression, or meningeal/brain stem metastases; (4) history of other primary malignant tumors; (5) diabetes symptoms or a history of diabetes; (6) acute or chronic pancreatitis; or (7) other severe diseases that might affect the safety and efficacy of patients. | PMC10757118 |
Procedure and assessments | Cancer | ADVERSE EVENT, DISEASE PROGRESSION, ADVERSE EVENTS, BLOOD, CANCER | This dose‐escalation trial employed a “Rolling 6” design,Blood samples were collected from each patient after a single dose of HS‐10352 on Day 1 of Cycle 0, followed by a 7‐day observation period. Repeated administration of the same dose commenced on Day 8, marking the beginning of Cycle 1. Each treatment cycle lasted for 4 weeks. Treatment with HS‐10352 would be discontinued in case of disease progression, adverse events (AEs), serious protocol violations, withdrawal of consent, or other circumstances as determined by the investigators or the sponsor.Treatment response was assessed by the investigators every 8 weeks according to RECIST v1.1. Patients were followed up for safety for 28 days after treatment discontinuation. Any AEs occurring during the trial were recorded and graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 5.0, | PMC10757118 |
E545D, Breast tumor | BREAST TUMOR, PIK3CA MUTATION | Breast tumor tissue samples were collected, and PIK3CA mutation status was determined by the central laboratory using the fluorescence quantitative PCR instrument (Cobas Z480) along with the PIK3CA Mutation Detection Kit (AmoyDx, Xiamen, China). This kit is specifically designed to detect the five hotspot PIK3CA mutations: H1047L, H1047R, E542K, E545K, and E545D. | PMC10757118 |
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Study endpoints | toxicity, SD | DISEASE | The primary endpoints were dose‐limiting toxicity (DLT) and MTD of HS‐10352. Secondary endpoints included safety, pharmacokinetics, objective response rate (ORR), disease control rate (DCR), duration of response (DoR), PFS, and overall survival (OS).DLT was defined as any grade ≥4 hematologic or grade ≥3 non‐hematologic toxicity that occurred from the single dose on Day 1 of Cycle 0 up to the last dose in the first repeated dosing cycle, which was unrelated to the disease but associated with the study drug per investigator judgment according to CTCAE version 5.0. MTD was defined as either the highest tolerable dose at which DLT occurred in no more than one patient or as the intermediate dose between the intolerable dose (where DLT occurred in two or more patients) and the previously determined highest tolerable dose. At the intermediate dose level, DLT should occur in no more than one patient during subsequent assessments. ORR was defined as the proportion of patients with a confirmed complete response (CR) or partial response (PR). DCR was defined as the proportion of patients with a confirmed CR, PR, or stable disease (SD). | PMC10757118 |
Statistical analysis | A “Rolling 6” design was adopted in this dose‐escalation study, with up to six evaluable patients enrolled in each dose group. The total number of participants was contingent on the number of dose‐escalation groups.Statistical analyses primarily utilized descriptive statistics. Continuous variables were presented as mean ± standard deviation or median (range) depending on the normality of the data. Categorical variables were presented as frequency (percentage). The 95% confidence intervals (CIs) for the ORR and DCR were calculated using the Clopper–Pearson method. The Kaplan–Meier method was employed to estimate the medians and 95% CIs of PFS and DoR. Statistical analyses were conducted using SAS version 9.4 (SAS Institute, Cary, NC, USA). | PMC10757118 |
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RESULTS | PMC10757118 |
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Patient characteristics | ONCOLOGY | A total of 28 patients were screened for eligibility between August 2020 and March 2022. Of these, 18 female patients with HR‐positive, HER2‐negative ABC were enrolled and treated with HS‐10352 (Figure Study flowchart.Baseline patient characteristics.Abbreviations: BMI, body mass index; CDK, cyclin‐dependent kinase; ECOG PS, Eastern Cooperative Oncology Group performance status; ER, estrogen receptor; HDAC, histone deacetylase; HER2, human epidermal growth factor receptor 2; PR, progesterone receptor; SD, standard deviation.PIK3CA mutation confirmed by the central laboratory.PIK3CA mutation confirmed by the central laboratory or past medical records.Others included one case of BEBT‐209, a novel CDK4/6 inhibitor being investigated in clinical trials, and one case of unknown medication. | PMC10757118 |
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Safety | DLTs, TRAEs | HYPERGLYCEMIA | In the 8 mg QD group, two patients experienced DLTs of grade 3 hyperglycemia. No DLTs were reported in other dose groups, indicating an MTD of 6 mg QD. The incidence rates of AEs and grade ≥3 AEs were 100% and 27.8%, respectively. TRAEs occurred in all patients, regardless of the drug dose (Table TRAEs occurring in ≥10% of patients.The median treatment exposure for HS‐10352 was 110.5 days (range, 12 to 525). The exposure duration was the longest in the 6 mg QD group (288.8 ± 140.73 days), which also had the highest cumulative exposure dose (1632.0 ± 793.67 mg) (Table | PMC10757118 |
Pharmacokinetics | Following a single‐dose oral administration of 2, 4, 6, or 8 mg in patients with ABC, HS‐10352 was rapidly absorbed. The median times to peak (Concentration–time curves in the 2, 4, 6, and 8 mg QD groups after single‐dose administration in Cycle 0 (A) and multiple‐dose administration in Cycle 2 (B).After multiple‐dose administrations, HS‐10352 reached the steady state by Day 8, with mean steady‐state maximum blood concentration ( | PMC10757118 |
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Efficacy | PD, tumor, tumors, mutated tumors | DISEASE, TUMORS, TUMOR | Five of the 18 patients had PR (4 and 1 in the 6 mg and 8 mg QD groups, respectively), with an ORR of 27.8% (95% CI, 9.7%–53.5%), a DCR of 55.6% (95% CI, 30.8%–78.5%) and a median PFS of 3.9 (95% CI, 2.0‐NA) months. In the 6 mg QD group, ORR and DCR were 66.7% (95% CI, 22.3%–95.7%) and 83.3% (95% CI, 35.9%–99.6%), respectively, and median PFS was not reached at the time of data cut‐off (Table Efficacy data.Abbreviations: CI, confidence interval; CR, complete response; DCR, disease control rate; NA, not available; NE, not evaluable; ORR, objective response rate; PD, progressive disease; PR, partial response; PFS, progression‐free survival; SD, stable disease.Waterfall plot for tumor response in individual patients. CR, complete response; PR, partial response; SD, stable disease; PD, progressive disease; Y, yes; N, no.For the 9 patients with PIK3CA mutated tumors confirmed by the central laboratory and/or previous medical records, ORR and DCR were 44.4% (95% CI, 13.7%–78.8%) and 77.8% (95% CI, 40.0%–97.2%), respectively. The median PFS was 11.1 (95% CI, 2.1‐NA) months (Table For the six patients with PIK3CA mutated tumors confirmed by the central laboratory, ORR, DCR, and DoR were 50.0% (95% CI, 11.8%–88.2%), 100.0% (95% CI, 54.1%–100.0%), and NA (95% CI, 9.1‐NA) months, respectively (Table For the 10 patients with PIK3CA wild‐type tumors confirmed by the central laboratory, the ORR and DCR were 10.0% (95% CI, 0.3%–44.5%) and 20.0% (95% CI, 2.5%–55.6%), respectively (Table Of the five patients with confirmed PR, three had PR at the first follow‐up visit for tumor assessment on Day 1 of Cycle 3 (C3D1), and the other two had PR at the third follow‐up visit on C7D1. For example, one PIK3CA‐positive patient in the 6 mg QD group had PR on C3D1, and the target lesion continued to shrink in subsequent follow‐up visits, maintaining PR as of the data cut‐off date (C15D1). Another PIK3CA‐positive patient in the 6 mg QD group had target lesion shrinkage on C3D1 and had PR on C7D1, maintaining PR as of the data cut‐off date (C13D1) (Figure | PMC10757118 |
DISCUSSION | tumor, tumors | ONCOGENESIS, REGRESSION, TUMOR, TUMORS | The efficacy of PI3K inhibitors has been confirmed in randomized phase 3 trials.The safety profile of pan‐PI3K inhibitors has been a limiting factor for their use in clinical practice.HS‐10352 exhibited favorable pharmacokinetic characteristics. According to the concentration–time curves, an increase in dosage did not correspondingly elevate the trough concentration after multiple administrations. Notably, the plasma level of HS‐10352 at an 8 mg dose appeared to plateau, suggesting dose saturation.PIK3CA mutations often result in hyperactivation of the PI3K/AKT/mTOR pathway, which is associated with oncogenesis, tumor development, and resistance to endocrine therapy in HR‐positive, HER2‐negative ABC.Given that inhibitors of the PI3K/AKT/mTOR pathway can mitigate endocrine therapy resistance in HR‐positive, HER2‐negative ABC, combination therapy emerges as a compelling strategy. Agents like fulvestrant can notably enhance the sensitivity of ER‐positive tumors to PI3Kα inhibition, thereby facilitating substantial tumor regression in vivo.Despite exhibiting a higher response rate compared with other PI3K/AKT/mTOR pathway inhibitors used as monotherapies in previous reports, | PMC10757118 |
CONCLUSION | mutated tumors | HS‐10352, administered at 6 mg once‐daily, was well‐tolerated in patients with HR‐positive, HER2‐negative ABC and showed promising antitumor activity, particularly in individuals with PIK3CA mutated tumors. These findings lend support to the further clinical development of HS‐10352, including its potential use in combination therapies such as endocrine therapy. | PMC10757118 |
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AUTHOR CONTRIBUTIONS | PMC10757118 |
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CONFLICT OF INTEREST STATEMENT | All authors declare no financial or non‐financial conflicts of interests. | PMC10757118 |
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ETHICS STATEMENT | The study protocol was registered at | PMC10757118 |
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Supporting information |
Click here for additional data file. | PMC10757118 |
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ACKNOWLEDGMENTS | We thank all the patients who participated in the trial, their families, and the site staff at the three participating centers, without whom this study could not be completed. We also thank the study teams of Hansoh Pharmaceutical Group Co. Ltd., including Hong Xu, Yong Yang, Tianyu Sun, Huifeng Zhang, Min Zhang, Xiangqing Yu, Jing Zhang, Yu Li, Xiaoyan Weng, Dongyue Shen, Jing Zhu, Yi Sun, Na Zhao, Lin Li, and Shanshan Li. This study received no funding. | PMC10757118 |
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DATA AVAILABILITY STATEMENT | All data generated or analyzed in this study are included in the published article and its supplementary information files. | PMC10757118 |
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REFERENCES | PMC10757118 |
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Background | Trauma | This experimental study was performed to evaluate the role of blended learning for technical skill teaching on the European Trauma Course (ETC). While online modules are extensively used for theoretical teaching, their role in skills training remains less well explored. The ETC currently relies on the established 4-step technique for teaching technical skills. However, the required large cohort of skilled instructors and the time intensity prove increasingly challenging in a current climate of staff shortages and funding constraints. This study assesses if blended learning, combining pre-course online elements with face-to-face training matches the effectiveness of the traditional 4-step approach whilst being more time-efficient. | PMC10644658 |
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Methods | SECONDARY | In a randomised, multi-centre trial, the conventional face-to-face 4-step technique for teaching a skill of medium complexity, the application of a pelvic binder, was compared with an innovative blended approach. It was hypothesised that the blended approach was non-inferior for skill performance measured after the teaching session and after two days (skill retention) with the time needed for teaching and student/teacher satisfaction as secondary outcomes. | PMC10644658 |
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Results | Ninety participants, divided into 44 traditional and 46 blended method students, were analysed. Independent-samples t-test showed no significant difference in performance scores and non-inferiority of the blended approach with a half of one standard deviation margin. A statistically significant difference in mean retention scores favored the blended approach. A Mann–Whitney U Test revealed no significant difference in candidate satisfaction levels but a statistically significant difference in instructors' satisfaction levels in favour of the blended approach. Analysis with Welch' t-test demonstrated that the face-to-face teaching time needed for the blended approach was significantly shorter (by 6 min). | PMC10644658 |
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Supplementary Information | The online version contains supplementary material available at 10.1186/s13049-023-01127-4. | PMC10644658 |
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Keywords | Open Access funding enabled and organized by Projekt DEAL. | PMC10644658 |
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Background | Trauma | Drawing from the lessons of the Covid pandemic, the International Liaison Committee on Resuscitation (ILCOR) has advised that all life support courses, including the European Trauma Course (ETC), embrace blended learning methodologies to enhance the resilience of teaching and training [An experimental study was devised to address the current evidence gap by evaluating the role of blended learning for technical skill teaching in the ETC. The ETC currently uses the 4-step technique [Step 1: Real time teacher demonstration of the skillStep 2: Explanation of the different skill stepsStep 3: Learner talking the teacher or peer learner through the steps whilst the teacher/peer learner performs themStep 4: Learner performs the skill stepsUnfortunately, when taught in small groups [The aim of the study was to determine if a blended approach can be equally effective and more time-efficient than the traditional 4-step approach. | PMC10644658 |
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Study methodology | trauma | Based on a post-positivist paradigm, this quantitative, experimental study compared two teaching techniques for their effectiveness. The hypotheses state that the blended approach will be non-inferior to the traditional approach in terms of skill performance, skill retention, student and teacher satisfaction and additionally will need less face-to-face teaching time compared to the traditional technique.The sample size was calculated based on previous skill performance score distributions of checklist ratings [The study population was made up of ETC candidates. Centres in England (Birmingham, Manchester, Stafford) and Belgium (Antwerp, Ghent) were selected for participation based on course availability, willingness to participate and researchers' travel duration. All candidates were contacted via email one month before their course. Prior exposure to any form of pelvic binder instructions was not counted as an exclusion criterion as the majority of ETC candidates work in trauma care and are expected to have had some exposure to pelvic binder application.The standard ETC Master Data File (MDF) on Microsoft Excel 2016 was used to randomly allocate participants to one of the two study groups. Participant information and consent forms kept details about the study hypotheses and teaching techniques confidential, blinding participants to these aspects. Instructors were manually assigned to the teaching sessions by a blinded course director. Double blinding was not possible due to the need for instructors to be informed about both teaching techniques to safeguard teaching consistency during the course. | PMC10644658 |
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Design | PMC10644658 |
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Setting | The study occurred over five courses, each lasting 2.5 days. Pelvic binder teaching sessions took place on the first day, with 2 to 4 instructors teaching groups of 4 candidates. Sessions for control and research groups were conducted simultaneously in different rooms, and instructors taught the same session three times. | PMC10644658 |
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Procedure for the control – and research group | Figure Study design. Two groups received skills training for pelvic binder application; a face-to-face 4-step approach for the control group and a blended modification for the research group. Both groups were assessed for their performance immediately after the teaching session and 2 days later (retention). Further outcome measurements were the time needed for teaching and learner/teacher satisfaction | PMC10644658 |
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Self-study for both groups | Candidates were expected to read the ETC course manual's pelvic binder instructions, before the course. | PMC10644658 |
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Online module for research group | The research group received an additional online module two weeks before the course, including theoretical content, videos showing step 1 and 2, online activities for step 3, and self-assessment questions.All instructors received the online module, with the instructors for the control group instructed to teach the skill as shown in the online module to standardise teaching. | PMC10644658 |
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Face-to-face teaching | trauma | Step 1 for both groups was a real-time demonstration of pelvic binder application during a simulated trauma scenario, aligning with the concept of contextual learning [Steps 2–4 for the control group involved a detailed explanation, followed by candidates guiding each other through the application with corrective feedback from the instructor and further time to practice.The research group, having completed steps 2 and 3 online, immediately performed step 4 with corrective feedback from the instructor and practice time.Instructors measured the time required to teach pelvic binder application. The control group's time covered steps 2 to 4, while the research group's time only included step 4. Step 4 was deemed complete when candidates felt competent to perform the skill. Although the control group had more steps, the effectiveness of the online module in preparing the research group was uncertain, possibly leading to a much longer step 4 for the research group due to more corrections and questions. | PMC10644658 |
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Assessment | Trauma | After step 4, instructors assessed candidates' skill performance using a standardised checklist, which was based on the regular ETC criteria and the European Trauma Course Manual [ | PMC10644658 |
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Evaluation | After the teaching session, candidates were asked to rate their satisfaction with the teaching technique on a 5-point Likert scale, covering the aspects of explanation, feedback, practice time, and assessment objectivity (Additional file Instructors also rated their satisfaction on a 5-point scale, focusing on time for feedback and practice, objectivity of assessment, and comparing blended learning to the standard technique if in the research group (Additional file | PMC10644658 |
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Retention | All candidates completed a second performance assessment (retention assessment) on day three in a separate room with an assessor, a research assistant and a manikin. | PMC10644658 |
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Data collection and analysis | Data collection was subjected to the European General Data Protection Regulation (2016). Data were analysed using SPSS Statistics version 29 (IBM). Descriptive statistics were given in terms of frequencies, means, medians, standard deviation, and range. Independent samples t-tests were used for performance and retention comparisons between groups, with non-inferiority calculations defining a margin of half a standard deviation [ | PMC10644658 |
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Results | PMC10644658 |
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Participants | A total of 108 candidates were invited to take part in the study and all agreed to participate by signing informed consent. Four participants were lost to attrition because they did not attend the course. Two participants from the control group were excluded because they had viewed the online module which a fellow participant of the research group had shared with them. Twelve participants were excluded because the instructor group deviated from the research protocol by including a different pelvic binder model into the teaching session. The remaining 90 study participants, were divided between traditional teaching (n = 44) and a blended approach (n = 46).Completion time of the online module varied, with 32 candidates taking 0–15 min and 10 candidates taking 15–30 min; data for 2 were missing. Previous exposure to training on the application of a pelvic binder was nearly equal between groups, with 25 in the control group and 28 in the research group, constituting 61% of each group. Data for 3 candidates in the control group were missing. | PMC10644658 |
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Performance score as outcome parameter | Both the control and research groups scored highly on the performance assessment, with mean scores of 17.07 (SD = 1.58) and 17.43 (SD = 0.98) respectively, out of a possible 18. An independent-samples t-test found no significant difference between the two groups (t (88) = −1.33, | PMC10644658 |
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Retention score as outcome parameter | The retention assessment was done two days after the teaching session, with mean scores for the control group at 15.66 (SD = 1.86) and 17.02 (SD = 1.33) for the research group. The difference in mean retention scores was statistically significant in favour of the research group (Performance and Retention scores for each group. Mean performance scores were not significantly different with 17.07 (SD = 1.58) and 17.43 (SD = 0.98) for the control and research group respectively. The independent-samples t-test showed significantly better ( | PMC10644658 |
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Satisfaction as outcome parameter | PMC10644658 |
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Candidate satisfaction | The general satisfaction with the teaching session was measured on a scale of 1 (very satisfied) to 5 (very dissatisfied). Both groups reported 98% 'satisfied' or 'very satisfied', with a higher proportion of 'very satisfied' in the control group (77% vs. 59%). The Mann–Whitney U Test found no significant difference in overall satisfaction between the control group (Median (Participants rated four aspects of the teaching session: explanation of indications for a pelvic binder, explanation of skill steps, instructor feedback, and practice time. Both groups reported over 90% 'satisfied' or 'very satisfied' for all items with no statistically significant differences between the groups for any of these items.Eighty-six out of 90 candidates (96%) agreed that the performance assessment with the standardised checklist was objective. | PMC10644658 |
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Instructor satisfaction | 24 instructors participated in the study, with 12 teaching the control group and 12 the research group (four instructors' data were excluded due protocol violation).Instructor satisfaction was measured on a 5-point Likert scale. Overall, 96% of instructors were satisfied or very satisfied (Fig. Instructor satisfaction with teaching session, by group. Satisfaction scores of instructors for the teaching technique they used was high for both groups, with no scores for unsatisfied or very unsatisfied. The research group reported a statistically significant higher proportion of very satisfied scoresAll research group instructors rated time for feedback and practice as sufficient, while two instructors of the control group scored this time as insufficient. All instructors agreed that the performance assessment was objective.Of the 12 instructors in the research group, 10 preferred the blended approach over the traditional teaching technique and 2 described it as equal. | PMC10644658 |
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Teaching time as outcome parameter | The study included 24 teaching sessions, 12 using traditional teaching and 12 using a blended approach. The traditional teaching sessions took a mean time of 12.61min (SD = 2.80), ranging from 8 to 17 min. The blended approach sessions took a mean time of 6.76min (SD = 0.99), ranging from 5 to 8 min (Fig. Mean teaching time per session, by group. Mean time of the traditional teaching session was 12.61min (SD = 2.80) and of research session 6.76min (SD = 0.99), showing a significant mean difference of 5.85 min (95% CI: 4.96 to 6.75, | PMC10644658 |
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Discussion | The study confirmed that the blended teaching approach was non-inferior to the traditional method in skill performance, skill retention and satisfaction, whilst reducing face-to-face teaching time. | PMC10644658 |
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Performance and retention scores | The results align with prior research showing no difference in performance scores when parts of the 4-step teaching technique are replaced by standardised videos [In this study, replacing teaching steps with best-practice videos and interactive exercises, led to equivalent performance and an even better retention in the research group, although the mean difference in retention score of 1.36 out of 18 should be considered small. Interestingly, the skill demonstration fostered observational learning in the control group but seemed to stimulate knowledge recall in the research group [ | PMC10644658 |
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Candidate satisfaction with the teaching session | Both teaching sessions were well received by the candidates, as 98% of each group reported high satisfaction levels. It should be noted that the control group reported a higher proportion of candidates (77%) to be 'very satisfied' compared to the research group (59%). In contrast to the present study results, students increasingly prefer to have control over their own learning so they can learn at their own pace and convenience [ | PMC10644658 |
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