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2.1. Study Design and Participants
obesity, adiposity
OBESITY, ADIPOSITY
The participants in this study were from a cluster randomized controlled trial named Diet, Exercise and Cardiovascular Health-Children (DECIDE-Children) conducted in 3 socioeconomically distinct regions from the eastern (Beijing), central (Changzhi, in Shanxi Province), and western (Urumqi, in Xinjiang Province) parts ...
PMC10574409
2.2. Outcome Assessment
adiposity
ADIPOSITY
The children’s obesity-related cognition and behaviors were collected through questionnaires at the baseline and at the end of the trial, which included (1) the children’s correct rate of answering obesity-related questions; (2) dietary habits (without the intake of sugar-sweetened beverages, snacks, fried food, wester...
PMC10574409
2.3. Assessment of Peer Network
Children were asked to fill out questionnaires at school at baseline for collecting data on children’s peer networks. Each child was asked to nominate his/her friends within the same class who met at least two of the following five conditions: they (1) play together almost every day during recess, (2) often play or do ...
PMC10574409
2.4. Statistical Analysis
Categorical variables were presented as numbers and percentages (%), and continuous variables with normal distribution were presented as means and standard deviations (SD). Basic characteristics were compared using student’s
PMC10574409
3. Results
PMC10574409
3.1. General Characteristics of Children
adiposity
ADIPOSITY
A total of 1392 children were involved in this study. The control group and intervention group had similar sociodemographic characteristics at baseline. There were no significant differences in the adiposity indicators and degree centrality between the two groups, while the difference in network size and network densit...
PMC10574409
3.2. Association of Peer Network with WCB and Adiposity Indicators
adiposity, overweight or obesity
ADIPOSITY
We found that out-degree centrality was positively associated with the WCB and negatively associated with the BMI z score at baseline. For each unit increase in out-degree centrality (i.e., the child nominated one more friend), the WCB increased by 0.172 (95%CI: 0.093 to 0.250), and the BMI z score decreased by 0.042 (...
PMC10574409
3.3. Association between Baseline Degree Centrality and Adiposity Indicators at the End of the Trial
The results of the linear mixed models showed that the baseline degree centrality was inversely associated with BMI and BMI z score at the end of the trial. Specifically, for each unit of increase in out-degree centrality at baseline (i.e., the child nominated one more friend), the BMI at the end of the trial decreased...
PMC10574409
4. Discussion
obesity, degree-centrality, overweight, adiposity, obesity-related behaviors
OBESITY, CHILDHOOD OBESITY, ADIPOSITY
This study found that the children’s degree centrality in their peer network was associated with obesity-related cognition, behaviors and adiposity indicators. Those socially active children in the class tended to have healthy obesity-related cognition, behaviors and adiposity indicators. We also found that in-degree c...
PMC10574409
5. Conclusions
obesity, cognition and behaviors
OBESITY
This study found that children with more friends in their peer networks tended to have healthy cognition and behaviors, and lower BMI. In addition, children who were more active and popular in their peer networks tended to benefit more from the intervention program. Future childhood-obesity intervention research should...
PMC10574409
Author Contributions
RECRUITMENT
P.L., J.L., S.Z., Z.L. and H.W. conceptualized and designed the research; P.L. performed statistical analysis and drafted the manuscript; P.L., J.L., S.Z., Z.L., X.F., Y.L., A.G. and F.Z. supported the recruitment and collected the data; P.L., H.W. and J.L. edited and revised the manuscript; and H.W. supervised the wor...
PMC10574409
Institutional Review Board Statement
The study was conducted in accordance with the Declaration of Helsinki and approved by the Institutional Review Board of Peking University (IRB00001052-18021). The study was registered at
PMC10574409
Informed Consent Statement
Informed consent was obtained from all the subjects involved in the study.
PMC10574409
Data Availability Statement
Data described in the manuscript, codebook, and analytic code will not be made available because the Peking University Institutional Review Board has not consented to this. In order to access more information on data analysis, contact the corresponding author at
PMC10574409
Conflicts of Interest
The authors declare no conflict of interest related to this work.
PMC10574409
2. Methods
fracture
SUBCUTANEOUS EMPHYSEMA, HEMODYNAMIC INSTABILITY, DECUBITUS, BRONCHOSPASM
This is a cross-randomized clinical trial developed at the Instituto de Cardiologia de Porto Alegre/RS Brazil, following the rules of the Consort Statement [The survey was carried out from February 2021 to December 2021, when all individuals were admitted to the Post-Operative Unit or Intensive Care Unit. We included h...
PMC9957294
Statistical Analysis
In the characterization of the sample, qualitative variables were expressed through absolute and relative frequencies, while quantitative variables were expressed through mean and standard deviations or standard error. The interactions between the group and moment of hemodynamic variables and ventilatory mechanics were...
PMC9957294
3. Results
delirium, ischemic intestinal ulcer, arrhythmias, seizures
ACUTE MYOCARDIAL INFARCTION, CARDIORESPIRATORY ARREST, ARRHYTHMIAS, COMPLICATIONS, HYPOXIC ENCEPHALOPATHY
A total of 36 subjects were selected for the study, of which 7 were excluded (During hospitalization, 11.1% had complications, such as delirium, acute myocardial infarction during surgery, seizures, ischemic intestinal ulcer, hypoxic encephalopathy, or the need for pacemaker placement and intra-aortic balloon; in addit...
PMC9957294
4. Discussion
obesity, hypertension, macrovascular complications
OBESITY, HYPERTENSION, CARDIOVASCULAR DISEASES, DYSLIPIDEMIA
According to the analysis of the results of this study, it is possible to observe that bronchial hygiene maneuvers are important maneuvers to carry out within a physiotherapeutic service in an intensive care unit, because although there is no difference between the force that is pushing away and between the techniques ...
PMC9957294
5. Conclusions
HEART DISEASE
Both analyzed maneuvers are capable of promoting airway clearance through the safe removal of secretions. Therefore, we observed that the techniques can be used in day-to-day physical therapy sessions for mechanically ventilated patients with heart disease. However, PEEP-ZEEP should preferably be used, since it can be ...
PMC9957294
Author Contributions
Writing—original draft, T.F.d.O.; Supervision, V.S.P.; Project administration, L.A.F.J. and B.E. All authors have read and agreed to the published version of the manuscript.
PMC9957294
Institutional Review Board Statement
The study was conducted in accordance with the Declaration of Helsinki, and approved by the Ethics Committee of Instituto de Cardiologia/Fundação Universitária de Cardiologia (IC/FUC) (protocol code 42228921.6.0000.5333; 25 January 2021) for studies involving humans.
PMC9957294
Informed Consent Statement
Informed consent was obtained from all subjects involved in the study.
PMC9957294
Data Availability Statement
Not applicable.
PMC9957294
Conflicts of Interest
The authors declare no conflict of interest.
PMC9957294
References
CAD
ACUTE PULMONARY EDEMA, PAD, PERIPHERAL ARTERIAL OCCLUSIVE DISEASE, CORONARY ARTERY DISEASE, CAD
Flowchart of patients included in the study.Amount of aspirated secretion between groups; median and interquartile ranges.Sample characteristics.CAD: coronary artery disease; PAD: peripheral arterial occlusive disease; APE: acute pulmonary edema; MV: mechanical ventilation; absolute and relative frequency values; * M ±...
PMC9957294
Rationale
coronavirus disease 2019
CORONAVIRUS DISEASE 2019, ACUTE RESPIRATORY DISTRESS SYNDROME
Health-related quality of life after surviving acute respiratory distress syndrome has come into focus in recent years, especially during the coronavirus disease 2019 pandemic.
PMC9899507
Objectives
acute respiratory distress syndrome
ACUTE RESPIRATORY DISTRESS SYNDROME
A total of 144 patients with acute respiratory distress syndrome caused by COVID-19 or of other origin were recruited in a randomized multicenter trial.
PMC9899507
Methods
Disability
DISEASE
Clinical data during intensive care treatment and data up to 180 days after study inclusion were collected. Changes in the Sequential Organ Failure Assessment score were used to quantify disease severity. Disability was assessed using the Barthel index on days 1, 28, 90, and 180.
PMC9899507
Measurements
high disability
REGRESSION
Mortality rate and morbidity after 180 days were compared between patients with and without COVID-19. Independent risk factors associated with high disability were identified using a binary logistic regression.
PMC9899507
Main results
disability, high disability
The SOFA score at day 5 was an independent risk factor for high disability in both groups, and score dynamic within the first 5 days significantly impacted disability in the non-COVID group. Mortality after 180 days and impairment measured by the Barthel index did not differ between patients with and without COVID-19.
PMC9899507
Conclusions
organ dysfunction
RESOLUTION, ACUTE RESPIRATORY DISTRESS SYNDROME
Resolution of organ dysfunction within the first 5 days significantly impacts long-term morbidity. Acute respiratory distress syndrome caused by COVID-19 was not associated with increased mortality or morbidity.
PMC9899507
Supplementary Information
The online version contains supplementary material available at 10.1186/s13054-023-04330-y.
PMC9899507
Keywords
Open Access funding enabled and organized by Projekt DEAL.
PMC9899507
Introduction
coronavirus disease 2019, ARDS
CORONAVIRUS DISEASE 2019, ACUTE RESPIRATORY DISTRESS SYNDROME, DISEASE, SAID, ARDS
Acute respiratory distress syndrome (ARDS) causes a significant reduction in long-term health quality; however, in most ARDS studies, the primary endpoint is patient mortality in the beginning.With improvements in intensive-care treatment, health-related quality of life (HRQoL) after survival of ARDS came into focus in...
PMC9899507
Materials and methods
PMC9899507
Study design and patients
ThIlo, critically ill, ARDS
RECRUITMENT, SECONDARY, ARDS, CRITICALLY ILL
The present study was a secondary analysis of the ThIlo trial, a prospective randomized multicenter trial assessing the efficacy of inhaled iloprost for the prevention of the development and progression of ARDS in critically ill patients. Study design and recruitment are described elsewhere [Iloprost treatment did not ...
PMC9899507
Data collection
In addition to baseline information, the SOFA score was collected at baseline and on days 1, 2, 3, 4, 5, and 15 after enrollment. The BI was used to evaluate the functional status. The BI was determined by telephone calls or patient interviews at baseline and on days 28, 90, and 180 after study inclusion. The patients ...
PMC9899507
Outcomes measures
low/moderate disability, moderate/slight dependence, disability, ARDS
SECONDARY, ARDS
The primary endpoint was disability at day 180, which was evaluated using the BI. The secondary endpoints included changes in the BI on days 28, 90, and 180 stratified by the etiology of ARDS (COVID-19 vs. non-COVID) and overall mortality at day 180. High disability was defined by a BI of 0–60 (total and severe depende...
PMC9899507
Power calculation
ThIlo, ARDS, high disability
REGRESSION, SECONDARY, ARDS
The ThIlo trial was powered for the primary endpoint (effectiveness of iloprost in ARDS). In this secondary analysis, a post-hoc power calculation was done to estimate the risk of high disability at day 180. The power calculation was based on a binary logistic regression model. An observed group size of 144 patients (1...
PMC9899507
Statistical analysis
All reported Categorical variables are expressed as absolute and relative frequencies. Quantitative variables are expressed as means and standard deviations or medians and interquartile ranges according to the distribution of the data. Normality of the distribution was assessed by investigating skewness and kurtosis as...
PMC9899507
Identification of independent risk factors
high disability
REGRESSION
Binary logistic regression was performed to evaluate independent risk factors for high disability by BI 180 days after study inclusion.Candidate risk factors for the multivariate model were selected based on clinical reasoning and the statistically significant results of the bivariate analyses. Multicollinearity was ch...
PMC9899507
Analysis of SOFA score dynamic
low/moderate disability, ARDS
ARDS
Changes in the BI at baseline, 28, 90 and 180 days after enrollment and ARDS aetiologies groups (COVID-19 vs. others) were evaluated using the nonparametric analysis for longitudinal Data “nparLD” (R-software) [Temporal changes in the SOFA score values during the first 14 days after enrollment were analyzed by linear m...
PMC9899507
Survival analysis
Overall survival was analyzed using the Kaplan–Meier method, and the log-rank test was used to test differences in survival curves.
PMC9899507
Missing data
Multiple imputations were used to replace missing data with plausible values based on observed data [
PMC9899507
Results
PMC9899507
Primary endpoint
PMC9899507
Secondary endpoints
PMC9899507
COVID-19 is not associated with a higher 180-day mortality
ARDS
ARDS
During follow-up, 48 patients died; the overall survival at 30, 60, and 90 days was 73.9%, 69.3%, and 67.1%, respectively. Figure Survival rates of patients with COVID-19 ARDS (
PMC9899507
COVID-19 is not associated with a risk of higher disability after ARDS
ARDS
ARDS
Table Barthel Index categories at baseline and after follow-up (Classification proposed by Shah et al. [Proportions of Barthel indices at indicated time points (0, 28, 90, and 180 days) of patients with COVID-19 ARDS versus non-COVID ARDS. Total dependency: BI 0–20; severe dependency: BI 21–60; moderate dependency: BI ...
PMC9899507
The dynamic SOFA score during the first 5 days was a predictor of high disability in non-COVID ARDS
ARDS
ARDS
We also compared the 180-day SOFA score trajectories stratified by the BI and etiology of ARDS (COVID-19 ARDS and non-COVID ARDS) using a linear mixed model (Fig. Line diagram of SOFA score stratified by Barthel index at 180 days and COVID-19 ARDS (Mixed effects model results showing the relationship between SOFA score...
PMC9899507
Discussion
multiorgan dysfunction, acute lung injury, disability, ARDS
SECONDARY, ARDS, SEQUELAE
Long-term sequelae after ICU therapy in patients with ARDS have become an increasing subject of interest in recent years, especially since the COVID-19 pandemic. The question of whether COVID-19 ARDS is associated with a higher mortality rate and increased risk of long-term impairment compared to ARDS of other origins ...
PMC9899507
Author contributions
LMSH and PM performed the statistical data analysis and designed the figures. AB, LMSH HAH wrote the manuscript. All authors were involved in collection of data, contributed to interpretation of data, revised the article critically for important intellectual content, approved the version to be published, and agreed to ...
PMC9899507
Funding
Open Access funding enabled and organized by Projekt DEAL. We acknowledge support by Open Access Publishing Fund of University of Tübingen. This study was funded by the AKF Program of the University of Tübingen (Grant No. 414-0-0) and in part by a Grant from the German Research Foundation DFG-RO 3671/8-1 to P.R.
PMC9899507
Availability of data and materials
After publication, the data will be made available upon reasonable request from the corresponding author.
PMC9899507
Declarations
PMC9899507
Ethics approval and consent to participate
ThIlo
The ThIlo trial has been conducted in accordance with Good Clinical Practice guidelines and the guiding principles of the Declaration of Helsinki. The trial was approved by the Institutional Review Board of the Research Ethics Committee of the University of Tübingen (899/2018AMG1) and the corresponding ethical review b...
PMC9899507
Competing interests
All authors declare that they have no conflict of interest regarding the ThIlo trial.
PMC9899507
References
PMC9899507
Background
colorectal cancer, CRC
COLORECTAL CANCER
A risk-stratified approach to colorectal cancer (CRC) screening could result in a more acceptable balance of benefits and harms, and be more cost-effective.
PMC10098832
Aim
COLORECTAL CANCER
To determine the effect of a consultation in general practice using a computerised risk assessment and decision support tool (Colorectal cancer RISk Prediction, CRISP) on risk-appropriate CRC screening.
PMC10098832
Design and setting
MAY
Randomised controlled trial in 10 general practices in Melbourne, Australia, from May 2017 to May 2018.
PMC10098832
Method
CRC
Participants were recruited from a consecutive sample of patients aged 50–74 years attending their GP. Intervention consultations included CRC risk assessment using the CRISP tool and discussion of CRC screening recommendations. Control group consultations focused on lifestyle CRC risk factors. The primary outcome was ...
PMC10098832
Results
A total of 734 participants (65.1% of eligible patients) were randomised (369 intervention, 365 control); the primary outcome was determined for 722 (362 intervention, 360 control). There was a 6.5% absolute increase (95% confidence interval [CI] = −0.28 to 13.2) in risk-appropriate screening in the intervention compar...
PMC10098832
Conclusion
A risk assessment and decision support tool increases risk-appropriate CRC screening in those due screening. The CRISP intervention could commence in people in their fifth decade to ensure people start CRC screening at the optimal age with the most cost-effective test.
PMC10098832
BACKGROUND
fits, colorectal cancer, Colorectal cancer, CRC
COLORECTAL CANCER, COLORECTAL CANCER
Australia has one of the highest incidence rates of colorectal cancer (CRC) worldwide.Risk-stratified approaches to CRC screening have been proposed where those at higher CRC risk have more invasive tests and commence screening at a younger age.How this fits inThere are discrepancies between Australian recommendations ...
PMC10098832
METHOD
The trial protocol has been published elsewhere.
PMC10098832
Participants
CRC
RECURRENT RECTAL BLEEDING, INFLAMMATORY BOWEL DISEASE
Eligible participants were aged 50–74 years and able to comprehend written English and give informed consent. Exclusion criteria were: previous diagnosis of CRC or inflammatory bowel disease; current rectal bleeding; and known genetic predisposition to CRC.Patients aged 50–74 years attending a GP were recruited consecu...
PMC10098832
Intervention group
polyp, CRC
The intervention occurred before the participant’s consultation with their GP and involved a standardised consultation delivered by a research assistant in which the participant’s risk of CRC was assessed using the CRISP tool; risk-appropriate CRC screening recommendations were discussed and a report provided to the pa...
PMC10098832
Control group
’, cancer, Cancer
CANCER, CANCER
Those randomised to the control group were directed to an online presentation of the Cancer Council Victoria ‘Cut your Cancer Risk’ brochure. The research assistant discussed the information using a standardised script; the focus was on modifiable lifestyle factors to reduce cancer risk. Participants received a copy of...
PMC10098832
Outcomes and measures
Anxiety, polyp
SECONDARY, RECRUITMENT, APPENDIX
The primary outcome was the proportion of participants who had completed risk-appropriate CRC screening at 12-month follow-up. In the intervention group, the risk category was defined using the CRISP-calculated 5-year CRC risk; for the control group, it was determined by their family history in accordance with the NHMR...
PMC10098832
Sample size
The original sample size was 278 participants per group, based on historic estimates of risk-appropriate screening of <5%.
PMC10098832
Randomisation and masking
bowel cancer
BOWEL CANCER
Participants were automatically randomised after the baseline questionnaire. The random allocation sequence, stratified by general practice, was computer-generated by the trial statistician with a 1:1 allocation ratio using random permuted block sizes of four, six, and eight within each stratum. This randomisation sequ...
PMC10098832
Blinding
For telephone follow-up of non-responders, and extraction and analysis of health service utilisation data, research staff were blinded to group assignment. All statistical analyses were performed blinded to group assignment.
PMC10098832
Statistical methods
REGRESSION, SECONDARY
All randomised participants who did not withdraw their data were included in the primary analysis. Those who died before the 12 months’ follow-up were excluded for the primary outcome, but their survey responses for secondary outcomes are included in the study. For the primary outcome, logistic regression was used to e...
PMC10098832
DISCUSSION
PMC10098832
Summary
Using a risk assessment and decision support tool in patients attending general practice increased risk-appropriate CRC screening by 6.5% in the whole intervention cohort. Although the 95% CI includes a true effect size of no difference, the authors cannot preclude a clinically important true intervention effect since ...
PMC10098832
Strengths and limitations
The intended sample size was recruited, with a high accrual rate; participants were representative of the local population. A hierarchical approach was applied to define the primary outcome using objective health services data in preference to self-report, and self-reported information was relied on for only three part...
PMC10098832
Comparison with existing literature
cancer
CANCER, BOWEL CANCER
A previous systematic review of cancer risk assessment tools, by the same study group, found that tools increase intentions to screen but the effects on risk-appropriate screening were unclear.Two trials of CRC risk assessment tools have reportedThe current complex intervention was more than a computerised risk assessm...
PMC10098832
Implications for practice
cancer, Cancer
CANCER, BOWEL CANCER, CANCER
The intervention led to higher rates of overscreening in those who were not due screening, mainly through overordering iFOBT tests. With the implementation of the National Cancer Screening Register, it should be possible to reduce this overscreening by determining when someone is due their next iFOBT. This information ...
PMC10098832
Funding
This trial was funded by a
PMC10098832
Ethical approval
Ethics approval was granted by the University of Melbourne Human Research Ethics Committee (reference: 1647804).
PMC10098832
Data
Data are not available at present.
PMC10098832
Provenance
Freely submitted; externally peer reviewed.
PMC10098832
Competing interests
The authors have declared no competing interests.
PMC10098832
Discuss this article
Contribute and read comments about this article:
PMC10098832
REFERENCES
PMC10098832
Purpose
breast cancer
BREAST CANCER
This study examined the effects of Fil-Rouge Integrated Psycho-Oncological Support (FRIPOS) in a group of women with breast cancer compared with a group receiving treatment as usual (TAU).
PMC10104919
Methods
The research design was a randomized, monocentric, prospective study with three time points of data collection: after the preoperative phase (T0), in the initial phase of treatments (T1), and 3 months after the start of treatments (T2). The FRIPOS group (
PMC10104919
Results
A series of independent and paired
PMC10104919
Conclusions
This study suggests that patients in the FRIPOS group have more benefits in emotional, psychological, and collateral symptoms than patients in the TAU group and that these improvements are due to integrated psycho-oncology care.
PMC10104919
Keywords
Open access funding provided by Università degli Studi di Torino within the CRUI-CARE Agreement.
PMC10104919
Introduction
cancer, Breast cancer
CANCER, BREAST CANCER
Breast cancer is the most commonly diagnosed cancer in Italian women [
PMC10104919
The psycho-oncological support
cancer
CANCER, DISEASE
Psycho-oncology is a branch of the oncology disciplines that is particularly concerned with two psychological dimensions: the psychological responses of patients and their families to all phases of disease and staff stress and the psychological, social, and behavioral factors that influence cancer onset and disease sur...
PMC10104919
Barriers to seeking psychological support in cancer patients
The communication gap between the patient and the medical staff is one of the main problems [
PMC10104919
Psycho-oncology as an integrated support in routine multidisciplinary cancer care
Whereas in the past, support was usually provided only at the patient’s request, today, the modality has evolved to the so-called tiered models (or stepped models) based on monitoring of suffering [This approach remains the most widely used and proven, including cost-effectiveness [An organized method of care that ensu...
PMC10104919
The FRIPOS project
Cancer
BREAST CANCER, CANCER
The Fil-Rouge Integrated Psycho-Oncological Support (FRIPOS) project is in line with the agreement of April 17, 2019, between the Italian State and its Regions, and the European Cancer Plan presented in February 2021 [The aim of this study was to evaluate the impact of the FRIPOS model compared with routine care in a s...
PMC10104919
Clinical steps and research procedure
breast radiologist/psycho-oncologist)Individual
DISEASE
As shown in Table Phases of the clinical project and moments of administration of the research projectAdministration of informed consentRandomization processIDiagnostic phaseIntegrated session with medical staff (breast radiologist/psycho-oncologist)Individual discussion with the psycho-oncologist for the management of...
PMC10104919
Ethics and research design
Cancer
CANCER
The intervention and the filling in of the questionnaires took place during the hospitalization in the surgical department and during the visit to the oncological day hospital and/or to the “Alte Energie” Center of the Oncological Radiotherapy Department of the Clinical Institute of S. Anna in Brescia — San Donato Grou...
PMC10104919
Measures
The instruments used are all standardized and validated in the Italian context.
PMC10104919