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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 of China from September 2018 to June 2019. There were 705 grade 4 students (about 10 years old in the Chinese school system) from 12 intervention schools and 687 from 12 control schools. Children of this age have the ability to complete questionnaires. Based on the socio-ecological model, dietary and exercise interventions for children were carried out in the intervention group at the school, family and individual levels. For the school level, we developed school obesity prevention policies including physical education sessions, healthy food environment, and health education sessions for teachers and children. For the individual level, we promoted children’s physical exercise at school and at home and recommended for them not to eat fried food, snacks, fast food, etc. For the family level, we conducted health education sessions for parents. In addition, an application on the mobile phone of the parents (named Eat Wisely and Move Happily) was used to conduct the regular monitoring and feedback of children’s diet and exercise behaviors and adiposity indicators, and promote the family involvement in the childhood-obesity intervention. Details of sampling and interventions can be found in previously published articles [ | 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, western fast food, and including eating breakfast every day); (3) exercise behavior (the number of days with ≥1 h moderate-to-vigorous physical activity per week); and (4) screen behavior (average daily screen time ≤ 2 h). In order to comprehensively evaluate obesity-related cognition and behaviors, the scores of the above 4 dimensions were added to obtain a score of Weight-control-related Cognition and Behavior (WCB), with each dimension scored according to a full score of 5. A higher WCB score indicated healthier obesity-related cognition and behaviors in a child [The adiposity indicators in this study included the body mass index (BMI) and BMI z score. Children’s anthropometric measures at the baseline and at the end of the trial were collected by trained personnel, using identical devices and standardized forms referring to standard methods and procedures. The BMI z score was calculated according to World Health Organization (WHO) standards [ | 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 homework together after school (>3 days/week), (3) often share snacks and toys, (4) often share extracurricular books, or (5) often go to school or go home after school together.The children’s friendship-nomination data were organized into a binary relational matrix, with the number of rows and columns equal to the total number of respondents in the class, and Ucinet 6 software was used to calculate peer network indicators at the individual and group levels. Peer network indicators included the network size, network density (group level) and degree centrality (individual level). Specifically, the network size was the number of children in each class, indicating the size of the relationship network within the class. The network density was the existing total number of friendship connections (ties) divided by the total possible number of ties within the same class, indicating the degree to which individuals in a peer network are connected to each other. Degree centrality was the total number of friends one child had. This could act as a measure of popularity or socially activeness in a peer network. Based on the direction of friendship nomination, the degree centrality was classified as out-degree and in-degree centrality in the social network analysis. Specifically, the out-degree centrality was the number of friendship nominations one child sent to others. And the in-degree centrality was the number of relationship nominations one child received from other classmates in their peer network. | PMC10574409 |
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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 |
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3. Results | PMC10574409 |
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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 density was statistically significant ( | 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 (95%CI: 0.001 to 0.083) in the children. The in-degree centrality was positively associated with the WCB and negatively associated with the BMI and BMI z score. For each unit increase in in-degree centrality (i.e., the child received one more friendship nomination), the WCB increased by 0.153 (95%CI: 0.064 to 0.241), BMI decreased by 0.184 (95%CI: 0.072 to 0.290), and BMI z score decreased by 0.066 (95%CI: 0.024 to 0.107). In addition, children with higher in-degree centrality had a lower risk of overweight or obesity (65.6%, 95%CI: 51.9% to 82.6%). And the network size was positively associated with BMI, but the association was no longer statistically significant after adjusting for parental educational level, parental nutritional status, etc. There were no statistically significant associations between the network density and WCB and adiposity indicators, nor between the network size and adiposity indicators (See | 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 by 0.042 (95%CI: 0.014 to 0.071), and the BMI z score decreased by 0.018 (95%CI: 0.007 to 0.029) in children; for each unit of increase in in-degree centrality at baseline (i.e., the child received one more nomination), the BMI at the end of the trial decreased by 0.047 (95%CI: 0.015 to 0.080), and the BMI z score decreased by 0.015 (95%CI: 0.003 to 0.028) in children (See | PMC10574409 |
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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 centrality was more closely associated with childhood obesity than out-degree centrality. This may be because a child’s in-degree centrality (i.e., the number of friendship nominations a child received from others) could more accurately reflect the popularity of the child within the peer network compared with out-degree centrality. Furthermore, the degree centrality of the children was inversely associated with the adiposity indicators at the end of the trial. In addition, children with a higher degree centrality had a larger reduction in their BMI and BMI z score in the obesity prevention program, indicating that more popular or central children in the class benefited more from the prevention program.The degree centrality in this study reflected the social status of children in the social environment within the class, indicating the degree to which children were welcomed by their peers (i.e., popularity or activeness). This study found out the association between the degree centrality and cognition, behaviors and adiposity indicators in the children, which was consistent with previous observational findings. It was found that there was a significant difference in centrality between the overweight and normal-weight children, with overweight children receiving fewer friendship nominations and less popularity among peers, suggesting the social marginalization of overweight children [This study identified that the degree centrality played a role on childhood obesity, and found that children with a higher degree-centrality had lower BMI and BMI z score at the end of the trial, indicating that children who were connected to their peers in class benefited more from the obesity intervention. This was consistent with the results of the School-EduSalt trial, which found out that children with more friends tended to have a larger salt intake reduction (β = 0.5, The strength of this study is that it is the first to explore the role of the peer network on childhood obesity, based on a well-designed randomized controlled trial that successfully decreased children’s BMI and BMI z score. We found that children with higher degrees of centrality had lower BMI or BMI z score at the end of the trial, which was consistent with findings in adult obesity intervention studies and other childhood behavioral interventions and observational studies. In addition, centrality was divided into in-degree and out-degree centrality based on peer network data, and it was revealed that in-degree centrality was more closely associated with children’s cognition, behaviors and adiposity indicators than out-degree centrality. For the association between the peer network and childhood obesity, the present prospective obesity intervention trial with a plausible temporal relationship overcame the possibility of reverse causality found in previous cross-sectional studies. And covariates such as the family support, socioeconomic status, self-efficacy, and class clustering effect were taken into account, making the results more reliable. However, the study had several limitations. First, the information about children’s obesity-related behaviors, including diet, exercise, and screen behaviors, were self-reported, and possibly affected by social desirability bias and recall bias. However, we found that the change in behavioral measures paralleled the changes in objective adiposity indicators, and the peer network indicators were inversely associated with adiposity indicators. Second, we identified friendships within the same classes, and lacked data of children’s other friends out of the class. Future studies are needed to identify a wider range of children’s friends to estimate children’s peer networks more comprehensively. Third, we explored the short-term association between the peer network and adiposity indicators. Future research could further explore the association between the peer network position in childhood and adulthood health outcomes. Lastly, although the research participants in the present study were from three socioeconomically distinct regions in China, from the eastern, central, and western parts, and included schools in rural and urban areas, the study’s applicability to larger populations and diverse cultural settings should also be considered with caution. | 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 pay more attention to socially inactive children and explore how to enhance obesity intervention effects among these children. | 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 work. All authors have read and agreed to the published version of the manuscript. | PMC10574409 |
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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 |
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Informed Consent Statement | Informed consent was obtained from all the subjects involved in the study. | PMC10574409 |
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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 |
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Conflicts of Interest | The authors declare no conflict of interest related to this work. | PMC10574409 |
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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 hemodynamically stable male and female patients aged over 18 years who used invasive mechanical ventilation for at least 48 h. Exclusion criteria were the presence of a chest drain, subcutaneous emphysema, rib fracture, hemodynamic instability (BP < 59 mmHg or 120 mmHg), severe bronchospasm, peak pressure > 40 cmHOf the 36 subjects, 31 met the inclusion criteria and were randomized by a blinded researcher, using the randomization.com program in a 1:1 crossover block, allocating the patient to one of the groups, and thus determining which of the techniques would be performed on the first day. Mucolytics were not administered in patients.The control group was established for the bag-squeezing technique and the intervention group for the PEEP-ZEEP maneuver associated with manual chest compression. In both, tracheal aspiration was performed 2 h before in order to match the groups in relation to the volume of secretion, and also immediately after the end of the techniques in order to measure the amount of secretion collected.Control tracheal aspiration was performed with the patient in dorsal decubitus and the headboard elevated at 30°, using a size-12 probe (Mark Med), with vacuum set at −40 cmHIn the control group, patients were in the supine position, and manual and rhythmic hyperinflations were performed, alternating with manual chest compressions during expiration. Insufflation was performed slowly with a high tidal volume, followed by an inspiratory pause of two to three seconds and then the rapid release of the resuscitator. The technique was performed for 10 uninterrupted minutes [Patients in the intervention group had their ventilatory mode adjusted to volume-cycled assist-controlled, and 6 mL/kg of predicted weight was calculated. During the maneuver, during the inspiratory phase, PEEP (positive end-expiratory pressure) was increased to 15 cmHHemodynamic data were recorded using the multiparameter monitor at the inpatient units (Philips), and respiratory mechanics data were collected from the mechanical ventilator screen (Servo S; Drager; Newport; Leistung) before and after the techniques. The amount of aspirated secretion was deposited in the collection flask (Water Seal 120 mL) and weighed on a high-precision Ohaus AdventurerTM scale, deducting the weight of the flask. | 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 evaluated through the EGE, and, when significant, the Bonferroni multiple comparisons test was used as a complement. Median and interquartile ranges were adopted to analyze the amount of secretion and the non-parametric Wilcoxon Signed-Rank test was used to compare groups. The significance level was 5%. Based on a previous study (WINPEP) [+], in order to detect a minimum difference of 1.4 g in the increase in secretion removal, with an error α = 5% and a power of 80%, the minimum number of calculated subjects was 122 (61 in each group), already accounting for possible losses. | PMC9957294 |
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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 addition, 14 (9.7%) patients had cardiorespiratory arrest, and 10 (6.9%) had arrhythmias. With regard to the use of medication, 17 (11.8%) needed vasoactive drugs, and 32 (22.2%) needed antibiotics (Regarding ventilatory therapy, the ventilatory modes used were PCV, VCV, PSV and IPPV, with PCV being the most frequent mode, with 13 (41.9%) patients in the control group and 12 (40%) in the intervention group. In addition, PEEP had a mean of 6.9 ± 1.3, while the FiOIn The comparison of ventilatory mechanics variables can be analyzed in The amount of aspirated secretion, represented by | 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 performed, the strategies that are used function by mobilizing the mucus and facilitating its removal via tracheal aspiration, in a safe way and without harming the hemodynamic state of the patient [As observed, most individuals have obesity, hypertension and dyslipidemia, factors that are associated with the appearance of cardiovascular diseases, as they predict the emergence of future micro- and macrovascular complications [Even with no significant differences, both techniques prove to be effective for mucus displacement and the removal of pulmonary secretions [Similar to this study, other findings prove that the bag-squeezing and PEEP-ZEEP techniques are safe in relation to individuals’ hemodynamic and ventilatory systems, as there were no significant changes that were sufficient for their decompensation [ | 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 performed without disconnecting the mechanical ventilation circuit, which reduces the risk of respiratory contamination. | PMC9957294 |
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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 |
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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 |
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Informed Consent Statement | Informed consent was obtained from all subjects involved in the study. | PMC9957294 |
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Data Availability Statement | Not applicable. | PMC9957294 |
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Conflicts of Interest | The authors declare no conflict of interest. | PMC9957294 |
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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 ± SD: mean and standard deviation.Ventilation therapy.MV: mechanical ventilation; PCV: pressure-controlled ventilation; VCV: volume-controlled ventilation; PSV: pressure support ventilation; IPPV: intermittent positive pressure ventilation; absolute and relative frequency values; * M ± SD: mean and standard deviation.Comparison of hemodynamic variables.Control group: bag-squeezing maneuver; Intervention group: PEEP-ZEEP maneuver; G*M: group versus moment; SBP: systolic blood pressure; DBP: diastolic blood pressure; MAP: mean arterial pressure; HR: heart rate; SpOComparison of ventilatory mechanics variables.Control group: bag-squeezing maneuver; Intervention group: PEEP-ZEEP maneuver; G*M: group versus moment; TV: total volume; PPeak: peak pressure; PPlateau: plateau pressure; DP: drive pressure; Cst: static compliance; Cdyn: dynamic compliance; * M ± SE: mean and standard error. | 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 |
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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 |
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Keywords | Open Access funding enabled and organized by Projekt DEAL. | PMC9899507 |
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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 the recent decade, and more than 200 instruments have been defined to assess HRQoL [To make long-term improvements for ARDS patients, rather than looking at the endpoint of a very differentiated disease pattern, the impact of single patient characteristics during ARDS therapy may help to interfere in advance, avoiding low HRQoL afterward. Therefore, we firstly strived to identify factors during intensive-care treatment of ARDS which significantly and independently influence functionality after ICU discharge, and can be used as outcome predictors in the future. Secondly, said factor or factors might not only serve as predictors, but could provide the chance to alter treatment and improve functionality after survival of ARDS.The recovery of patients and the quality of life after intensive care therapy for ARDS have even gained significant public interest during the coronavirus disease 2019 (COVID-19) pandemic due to the large number of patients requiring ARDS therapy.In this context, the question arises if ARDS based on COVID-19 is associated with a higher mortality or morbidity than ARDS of other origins, or if it’s “ | PMC9899507 |
Materials and methods | PMC9899507 |
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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 show any significant effect on the outcomes of these patients; therefore, a secondary analysis was performed. | 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 who died were assigned a score of 0. The BI scale was categorized into five groups (1) total dependency: 0–20 points, (2) severe dependency: BI 21–60 points, (3) moderate dependency: 61–90 points, (4) slight dependency: BI 91–99, and (5) independence 100 points [ | PMC9899507 |
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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 dependency), and low/moderate disability by a BI of 61–100 (moderate/slight dependence and independence). Secondary endpoints included changes in the BI on days 28, 90, and 180 stratified by the etiology of ARDS (COVID-19 vs. non-COVID-19), change in SOFA score within 15 days follow-up and day 180 overall mortality. | 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 (144 with COVID-19 and 44 without COVID-19) was used for the power calculation. The outcome of high disability, which occurred in 57% of patients, requires an OR of 3.1 (or OR: 0.32) to achieve a power of 80% with an alpha of 5%. The calculation was performed using the software PASS 2020. | 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 well as QQ graphs and histograms. Categorical variables were compared using XContinuous variables were compared using an independent sample Student’s t-test for normally distributed data or the Mann–Whitney Changes in the BI at baseline and after were evaluated using the nonparametric analysis for longitudinal Data “nparLD” (R-software) [ | PMC9899507 |
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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 checked using matrix correlation and variable inflation factors (VIF). Backward selection was used to remove the variables from the model sequentially. In addition, model comparisons were made using the log likelihood test (nested models), calibration was assessed with the Hosmer–Lemeshow goodness-of-fit test, and the area under the receiver operating characteristic curve (AUC) was used to examine the discrimination ability. The best fit model was used as final model. The results of the univariate and multivariate analyses are presented as odds ratios (OR), 95% confidence intervals (CI), and | 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 mixed model with random intercept. For this, BI high disability vs. low/moderate disability at day 180, ARDS etiologies (COVID-19 vs. others) and the interaction term “BI: Covid”, were entered as fixed effect variables. | 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 |
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Missing data | Multiple imputations were used to replace missing data with plausible values based on observed data [ | PMC9899507 |
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Results | PMC9899507 |
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Primary endpoint | PMC9899507 |
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Secondary endpoints | PMC9899507 |
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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 61–90; slight dependency: BI 91–99 and independence BI: 100. [baseline: | 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, Barthel index at day 180, and COVID-19To reduce collinearity, the variables COVID yes and Barthel index were labeled as follows: not: − 0.5 and yes: 0.5 and time was centered*High disability: Barthel index 0–60No differences were observed between the group COVID-19 ARDS vs. non-COVID ARDS on the mean SOFA score (In patients without COVID-19 ARDS, low vs. high disability at day 180 was significantly positively associated with higher SOFA score over time (β = 3.52, 95% CI 0.69; 6.35, | 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 is widely discussed. Similar to previous findings [Previous research has shown that patients with COVID-19 have a high prevalence of disability after ICU treatment [It is unquestionable that patients with ARDS are at risk of sustaining long-term impairment. Previous studies have described impaired quality of life and pulmonary function in patients with acute lung injury [The identification of risk factors for impairment after ARDS survival might provide the opportunity to intervene specifically to improve patient outcomes. Similar to previous studies, this study shows that age is a significant but non-amendable factor for disability after discharge [In addition to age, our findings revealed that health status on day 5 in ICU (reflected by the SOFA score) significantly impacted disability after discharge. Our results are consistent with Herridge et al. [The SOFA score was chosen because it is an estimated marker for mortality in ICU patients [For COVID-19 ARDS, the SOFA score dynamic up to day 5 was not significant.Independent of the dynamic, however, the SOFA score on day 5 significantly influenced disability after ARDS in both groups. This shows the importance of the state of the patient on day 5.However, the question arises if the outcome depends on the well-timed initiation of therapy [Our data are limited, as we did not evaluate patients’ health status prior to their ICU admission. Data on frailty, specifically, prior to ICU admission were not surveyed; however, it would have been of interest since frailty per se is a predictor for ICU length of stay, length of mechanical ventilation, and mortality [Our study was not primarily designed to define the quality of life or compare COVID-19 ARDS with ARDS of other origins, but is a secondary analysis of the interventional ThIlo trial.The trial started in the spring of 2019, before the beginning of the COVID-19 pandemic, and lasted until spring of 2021. During the course of the pandemic, specific treatment of COVID-19 patients changed, and in the beginning varied from “wave to wave”. Therefore, systematic comparison of COVID-19 ARDS with non-COVID-ARDS is not as simple. All in all, there certainly were variables-also within the therapy-which differed over time, and were not systematically evaluated and compared. As data were collected up until spring of 2021, none of our COVID-19 patients were vaccinated. Therefore, our results might not reflect the current morbidity and mortality that COVID-19 ARDS brings with it, as vaccination and more specific COVID-19 treatment is available now.In summary, the mortality of COVID-19 ARDS in our study population was not higher than that of ARDS of other origins and was not associated with an increased risk of disability. In both groups, early recovery from multiorgan dysfunction reduced disability after ICU discharge. The development of SOFA score within the first 5 days or SOFA score on day 5 significantly impacted patient outcome. Further research on the timing of intensive care treatment could help reduce mortality and health care costs in patients with ARDS. | 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 be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved. All authors read and approved the final manuscript. | PMC9899507 |
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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 |
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Availability of data and materials | After publication, the data will be made available upon reasonable request from the corresponding author. | PMC9899507 |
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Declarations | PMC9899507 |
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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 boards of all the participating centers. The trial was approved by the Federal Institute for Drugs and Medical Devices (BfArM, EudraCT No. 2016-003168-37) and registered at clinicaltrials.gov (NCT03111212). Each patient or legal representative, respectively, was informed of the modalities of the clinical study in accordance with the provided patient information. It was made clear that consent could be withdrawn at any time without giving reasons and without any negative consequences for the patient. Informed consent was obtained from the patient using a form approved by the Ethics Committee (EC) of the University of Tübingen or the local EC if the patient was treated in a collaborating institution. The patient or their legal representative and physician/investigator personally signed an informed consent form with an integrated declaration on data privacy protection. | PMC9899507 |
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Competing interests | All authors declare that they have no conflict of interest regarding the ThIlo trial. | PMC9899507 |
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References | PMC9899507 |
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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 |
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Design and setting | MAY | Randomised controlled trial in 10 general practices in Melbourne, Australia, from May 2017 to May 2018. | PMC10098832 |
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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 risk-appropriate CRC screening at 12 months. | PMC10098832 |
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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 compared with the control group (71.5% versus 65.0%; odds ratio [OR] 1.36, 95% CI = 0.99 to 1.86, | PMC10098832 |
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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 |
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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 and actual screening behaviours. Approximately 18% of people at average risk are being screened by colonoscopy, whereas 64% at moderate risk and 56% at high risk of CRC are receiving no screening at all.Internationally, there are guidelines that apply family history criteria for risk-stratified CRC screening, with colonoscopy for those at increased risk,The Colorectal cancer RISk Prediction (CRISP) trial aimed to test the effect of a health consultation in Australian general practice using a risk assessment and decision support tool (the CRISP tool) on risk-appropriate CRC screening. | PMC10098832 |
METHOD | The trial protocol has been published elsewhere. | PMC10098832 |
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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 consecutively from the waiting room and taken into a private room to confirm eligibility and obtain informed consent. An online baseline questionnaire was completed before randomisation. | 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 participant and their GP. This was designed to model the role of a practice nurse, the most likely method of implementation of the CRISP tool in general practice, based on this current study group’s previous developmental studies.The CRISP tool is a web-based application that calculates an individual’s 5-year and lifetime risk of developing CRC (Participants were encouraged to discuss the CRISP report with their GP. Those due an iFOBT test were shown how to complete the test and their GP was expected to order an iFOBT. Participants due iFOBT screening received an SMS (short message service) reminder at 1 month to complete the test. If the participant reported a history of polyps, the GP received a summary sheet about NHMRC polyp surveillance guidelines, asking them to arrange colonoscopic surveillance. These components were part of a complex intervention to improve risk-appropriate CRC screening. | PMC10098832 |
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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 the brochure and continued with usual care. | 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 NHMRC-endorsed guidelines that were current at the time of recruitment (Supplementary Appendix S1).CRC screening was obtained from multiple sources: self-report; GP record audit; Medicare Benefits Schedule (MBS, see Supplementary Table S1); the NBCSP; and the Victorian Admitted Episodes Dataset (VAED). In the current study self-reported data were used only where objective data from these clinical and administrative sources were unavailable.A clinical subcommittee reviewed blinded screening data for cases where there were discrepancies between data sources or to review participants with complex polyp histories (Supplementary Appendix S1).Additional measures included: demographics and clinical variables at baseline, and the following secondary outcomes:
risk perception, absolute, and comparative risk;State–Trait Anxiety Inventory (STAI) scale;cancer-specific anxiety;intentions to have CRC screening;clinical outcomes of screening tests (to be reported with 5-year follow-up); andhealthcare service utilisation and costs related to CRC screening at 12 months obtained from GP records, MBS, VAED, and NBCSP data (Supplementary Appendix S1).Participant-completed measures (a–d) were collected at baseline, 1, 6, and 12 months post-randomisation. | PMC10098832 |
Sample size | The original sample size was 278 participants per group, based on historic estimates of risk-appropriate screening of <5%. | PMC10098832 |
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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 sequence was incorporated into the online platform used to collect baseline data and redirect the browser to the CRISP tool or the control presentation. Participants were told the trial was about bowel cancer prevention and therefore blinded to allocation. | 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 |
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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 estimate the odds ratio (OR). A generalised linear model was used with the identity link function and binomial family to estimate the absolute difference in the proportion of risk-appropriate screening between groups. All regression models included the randomisation stratification factor of general practice as a fixed effect. The absolute (between-group difference in the proportions) and relative (OR) estimated effect sizes are presented with their respective 95% confidence interval (CI), and the Comparisons between groups on continuous secondary outcomes used a linear mixed-effects model that included trial group, general practice, and time (baseline, 1, 6, and 12 months) as fixed effects and individuals as random effects, with two-way interactions between group and time, except for baseline where study group means were constrained to be equal. Comparisons between groups on binary secondary endpoints with repeated outcome measures were performed using logistic regression, using generalised estimating equations with robust standard errors, with general practice as the covariate.Based on review of the blinded data, the trial steering committee agreed to conduct an explanatory analysis using a statistical test for interaction to examine if the intervention effect was modified by whether participants were due CRC screening during follow-up.Costs for delivering the intervention and associated with screening utilisation were expressed as the mean expenditure and associated 95% CI for iFOBT and colonoscopy over the period of the trial for each group, including overscreening. The cost per appropriately screened individual was calculated for the CRISP intervention compared with usual care based on the primary outcome measure and for those due screening at baseline. | PMC10098832 |
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DISCUSSION | PMC10098832 |
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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 the CI includes the possibility of a 13% increase in risk-appropriate screening, higher than originally hypothesised. In an explanatory analysis, the intervention effect was more evident in people who were due CRC screening, with a 20% absolute increase in risk-appropriate screening over 12 months compared with the control group. | PMC10098832 |
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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 participants for the primary analysis. To maintain blinding, risk-appropriate screening was defined based on the risk assessment method specific to each trial group. There were complete data for the primary outcome for 99% of trial participants. The sensitivity analyses showed the findings were robust to different assumptions.Including participants who were not due CRC screening during follow-up diluted the observable effect of the intervention. They were included because in the current study the authors were interested in effects on risk-appropriate screening, both under- and overscreening, in average and increased risk groups. The rate of risk-appropriate screening in the control group who were due screening was only 39%, similar to rates of participation in the national screening programme. It was not possible to confirm whether someone was genuinely due screening in the 12-month follow-up until the authors obtained the objective screening data from health records and knew their baseline risk. The preliminary estimates of baseline risk-appropriate screening, on which the original and revised sample sizes were based, could not adequately account in advance that only 50% of the sample were due CRC screening during the follow-up period. Although guidelines recommend CRC screening in those at increased risk from age 40 years, a decision was made to recruit a sample aged 50–74 years. If a younger cohort had been recruited, an even larger proportion of participants who were not due screening during follow-up would have been included in the study. | PMC10098832 |
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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 assessment or a simple reminder to complete screening of any kind. It included a discussion about bowel cancer, demonstration of the iFOBT kit, and prompting of GPs to order the risk-appropriate screening test. The ‘attention control’ was designed to account for the non-specific effects of the intervention. This was an efficacy trial to test whether delivery of the CRISP intervention in a standardised way could improve risk-appropriate screening. | 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 in the National Cancer Screening Register could also be used to determine when a CRISP risk assessment should be performed. The current intervention aimed to reduce colonoscopies in people at average risk of CRC. Five-year follow-up data will be reported on potential reductions in colonoscopies in average-risk patients and the longer-term cost-effectiveness of the CRISP tool.Risk-stratified screening targets more intensive screening to populations with higher rates of cancer, and, if fully implemented, would reduce screening intensity in those at lower risk.The authors thank all the trial participants and general practices who were involved in this trial. The authors are grateful to the Victorian Department of Health and Services Australia for their support in obtaining Victorian Admittted Episodes Dataset, Medicare Benefits Schedule, and National Bowel Cancer Screening Program data. | PMC10098832 |
Funding | This trial was funded by a
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Ethical approval | Ethics approval was granted by the University of Melbourne Human Research Ethics Committee (reference: 1647804). | PMC10098832 |
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Data | Data are not available at present. | PMC10098832 |
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Provenance | Freely submitted; externally peer reviewed. | PMC10098832 |
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Competing interests | The authors have declared no competing interests. | PMC10098832 |
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Discuss this article | Contribute and read comments about this article: | PMC10098832 |
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REFERENCES | PMC10098832 |
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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 |
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Results | A series of independent and paired | PMC10104919 |
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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 |
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Keywords | Open access funding provided by Università degli Studi di Torino within the CRUI-CARE Agreement. | PMC10104919 |
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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 survival [ | 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 |
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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 ensures that all of the patient’s needs are met in a coherent and seamless manner is referred to as an “integrated system of care.” Proposals have emerged around the world in the last decade, and although development is ongoing, studies appear promising. These procedures are integrated into clinical routines and address all patients, at least in the initial phase [ | PMC10104919 |
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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 sample of women with breast cancer. | 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 experiences related to the diagnosisIIPre-surgery phaseIntegrated session with medical staff (breast radiologist/surgeon/psycho-oncologist)Individual discussion with the psycho-oncologist for the emotional management of the pre-surgery experienceT0Administration of the socio-demographic questionnaireAdministration of SCL-90-RIIIInitial phase of treatmentIntegrated session with medical staff (surgeon/radiotherapist/psycho-oncologist)Individual discussion with the psycho-oncologist for the emotional management of the experience related to the treatment phaseT1Administration of EORTC QLQ-C30Administration of EORTC QLQ-BR23IVFollow-up during the treatmentIntegrated session with medical staff (surgeon/radiotherapist/psycho-oncologist)Individual discussion with the psycho-oncologist for the emotional management of the experience related to the treatment phaseT2Administration of SCL-90-RAdministration of EORTC QLQ-C30Administration of EORTC QLQ-BR23The overall clinical goals of the intervention were identified by consulting the clinical scientific literature and can be summarized as follows: (A) encouraging the patient to adapt to the new condition by helping her cope with the physical, psychological, social, and relational changes caused by the disease [We hypothesized that women who received integrated support would have lower scores for psychopathological symptoms, better psychological and emotional functioning, and better quality of life parameters than the group that received treatment as usual (TAU). | 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 Group. The project was approved by the Ethics Committee of the Clinical Institute of S. Anna in Brescia (Prot. Number: 2016.1.1; June 6, 2016).The questionnaires were labeled with an alphanumeric code, the combination of which was known only to the nursing staff responsible for randomization. The medical staff and the researchers who performed the data analysis were blinded to this information.The research design was a randomized, prospective study with triple data collection according to the steps of the clinical intervention: preoperative phase (T0), initial phase of treatments (T1), and 3 months after the start of treatments (T2) (Table In the pre-study phase, nurses informed patients of the opportunity to participate in the research project, obtained informed consent, and performed randomization using the online software Research Randomizer (version 4.0). The Symptom Checklist-90-R (SCL-90-R) was used only at T0 and T2 because it was considered a specific and primary tool for evaluating the FRIPOS program by assessing symptom indices at baseline and at the end of the project. At T1 and T2, patients completed two quality of life (QLQ) questionnaires developed by the European Organization for Research and Treatment of Cancer (EORTC), namely C-30 and BR-23. | PMC10104919 |
Measures | The instruments used are all standardized and validated in the Italian context. | PMC10104919 |
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