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Study population and recruitment
SECONDARY
Schools, pupils and staff were recruited using a two-stage randomized cluster design with proportional allocation by province and sociodemographic background. In the first stage, 41 clusters were identified in which one primary school and one secondary school were selected at random from a list of all Belgian schools p...
PMC10185463
Sample size
SECONDARY
A sample size of 800 pupils and 400 staff at each school level (primary and secondary schools) was calculated to estimate the seroprevalence with a margin of error of 2.3% for pupils and 3.0% for staff, assuming a seroprevalence of 6% among pupils and 10% among staff and a cluster design effect of two. All participants...
PMC10185463
Data collection
The local study coordinator – a staff member of the participating school – collected the data on the implementation of IPC measures via a secured online questionnaire using the ‘LimeSurvey’ platform (LimeSurvey version 3.22.24 + 2,000,630; see Supplement During each data collection period, the prevalence of anti-SARS-C...
PMC10185463
Implementation of IPC measures
The implementation of IPC measures in Belgian schools is presented using data from three data collection periods (December 2020/January 2021, March 2021 and May/June 2021).IPC measures were grouped according to the target age as: [For each data collection period, we reported the number and proportion of schools that im...
PMC10185463
Relation between the implementation of IPC measures and prevalence of anti-SARS-CoV-2 antibodies
SECONDARY
Based on the data collected during the first data collection period (December 2020/January 2021), we assessed whether the implementation of IPC measures was associated with the prevalence of anti-SARS-CoV-2 antibodies among pupils and staff in primary and secondary schools. Only schools that provided an answer for at l...
PMC10185463
Ethics approval
The study was approved by the Medical Ethics Committee of the University Hospital Ghent (reference: B6702020000744—BC-08564). Before enrolment, written informed consent was obtained from staff and parents of participating pupils, and informed assent was obtained from pupils.
PMC10185463
Results
PMC10185463
Participating schools
SECONDARY, RECRUITMENT
We contacted 98 primary and 108 secondary schools of which 44 primary and 40 secondary schools agreed to participate. Of these 84 schools, 45 belonged to the Dutch and 39 to the French language network. All but one school (Eighty-one schools (43 primary and 38 secondary) fulfilled the requisite 10 (out of a total of 14...
PMC10185463
Relation between IPC measures implementation and prevalence of anti-SARS-CoV-2 antibodies among pupils and staff
Figure Prevalence of anti-SARS-CoV-2 antibodies according to the degree of IPC measure implementationData collected at December 2020/January 2021 in Belgian schools among pupils and staff. The black lines indicate the upper and lower 95% confidence intervals. When this analysis was repeated for each subcategory of meas...
PMC10185463
Discussion
MAY, SECONDARY, HOLIDAY
Apart from some ventilation and physical distancing measures, most IPC measures were implemented by more than 60% of primary and secondary schools. Overall, the implementation of IPC measures was similar in primary and secondary schools. However, since reopening in May 2020, more primary than secondary schools reported...
PMC10185463
Conclusion
SECONDARY
Most Belgian primary and secondary schools of both language networks complied relatively well with recommended IPC measures. Poor implementation of all such IPC measures together and separately, by ventilation, hygiene and physical distancing subcategory, showed an increase in the prevalence of anti-SARS-CoV-2 antibodi...
PMC10185463
Acknowledgements
INFECTIOUS DISEASES, SECONDARY
All participants: Primary and secondary schools, school staff, pupils and their parentsBiological sample collection: All participating nursesBiological sample transportation: Sciensano’s Sample Management (BBC transport services)Biological sample analysis: Caroline Rodeghiero and Fabienne Jurion, expert technicians at ...
PMC10185463
Authors’ contributions
MR
RECRUITMENT
Concept, design, protocol writing: JM, MR and ED; Recruitment of participants and logistical coordination: MC, IK and MV; Administrative, technical, or material support: all authors; Biological sample collection and transport: MC and IK; Biological sample analysis: ID; Epidemiological data collection: IK, ED; Epidemiol...
PMC10185463
Funding
This study was funded by the Belgian government (COVID-19 SC_044A) through Sciensano, the Belgian institute of Public Health, Brussels, Belgium.
PMC10185463
Availability of data and materials
The data used in the current study are not publicly available due to privacy concerns, but data that support the current findings are available from the corresponding author on reasonable request.
PMC10185463
Declarations
PMC10185463
Ethics approval and consent to participate
The study was conducted in accordance with the Declaration of Helsinki and approved by the Medical Ethics Committee of the University Hospital Ghent (reference: B6702020000744—BC-08564). Written informed consent was obtained from all staff and parents of participating pupils before enrolment. Additionally, written info...
PMC10185463
Consent for publication
Not applicable.
PMC10185463
Competing interests
The authors declare no competing interests.
PMC10185463
References
PMC10185463
Background
cancer
CANCER, METASTATIC BLADDER CANCER
Patient-reported outcomes (PROs) are getting widely implemented, but little is known of the impact of applying PROs in specific cancer diagnoses. We report the results of a randomized controlled trial (RCT) of the active use of PROs in patients with locally advanced or metastatic bladder cancer (BC) undergoing medical ...
PMC10562329
Methods
We recruited patients from four departments of oncology from 2019 to 2021. Inclusion criteria were locally advanced or metastatic BC, initiating chemo- or immunotherapy. Patients were randomized 1:1 between answering selected PRO-CTCAE questions electronically once weekly with a built-in alert-algorithm instructing pat...
PMC10562329
Results
METASTATIC DISEASE
228 patients with BC were included, 76% were male. 141 (62%) of the patients had metastatic disease. 51% of patients in the IA completed treatment vs. 56% of patients in the CA, OR 0.83 (95% CI 0.47–1.44,
PMC10562329
Conclusions
This RCT did not show an effect of PRO on completion of treatment, hospitalizations or OS for BC patients during MOT despite a high level of patient and clinician compliance. The lack of real-time response to alerts remains the greatest limitation to this study.
PMC10562329
Supplementary Information
The online version contains supplementary material available at 10.1186/s41687-023-00640-5.
PMC10562329
Keywords
Open access funding provided by Royal Library, Copenhagen University Library
PMC10562329
Introduction
Bladder cancer
BLADDER CANCER, DISEASE
Bladder cancer (BC) patients with advanced stages of disease have a poor prognosis [In this study we report the effect of weekly ePROs as an intervention compared to standard of care for BC patients receiving chemo- or immunotherapy with the aim of reducing rate of hospital admissions during treatment and prevent early...
PMC10562329
Methods
PMC10562329
Patients
urothelial carcinoma of the bladder, Cancers, muscle-invasive bladder cancer
ADVERSE EVENT, CANCERS
From 15th of January 2019 all patients with urothelial carcinoma of the bladder initiating chemo- or immunotherapy (cisplatin/gemcitabine, carboplatin/gemcitabine, pembrolizumab or vinflunin) as neoadjuvant treatment for muscle-invasive or locally advanced BC (from here on referred to as locally advanced BC) or palliat...
PMC10562329
The control arm
Patients assigned to the control arm (CA) followed standard procedure for handling of side effects and symptoms as informed by the treating department. The patients completed QoL questionnaires once every three weeks, as shown in Table Frequency of questionnaires and clinical visits for control arm
PMC10562329
Statistical analysis
Musoro, death
On the basis of rates of treatment completion from a previous study and literature review, the current study was planned to include 230 patients. Prior data indicated that the rate of treatment cessation among controls was 50% [The proportion of patients experiencing early treatment cessation, hospitalization or dose r...
PMC10562329
Ethical considerations
The study was approved by the Danish Data Protection Agency (suite nb: RH-2017–348), registered at
PMC10562329
Results
deaths
PATHOLOGY
From 22nd January 2019 to 19th March 2021, we enrolled a total of 230 patients. Two patients were later excluded due to final pathology report requiring a different treatment than that of our inclusion criteria and another did not initiate treatment. The analysis therefore included 228 patients, Fig. CONSORT diagram of...
PMC10562329
Discussion
toxicity, cancer, anxiety, breast cancer
CANCER, METASTATIC MELANOMA, SIDE EFFECT, BREAST CANCER
In this multicenter randomized trial testing the active use of PROs during systemic oncological treatment for BC patients, we found a high rate of completed questionnaires and a high rate of clinician viewing of the patient-reported symptoms. For the primary endpoints, no statistically significant differences were foun...
PMC10562329
Conclusions
bladder cancer
BLADDER CANCER
Conclusively, we did not find ePROs effective for the bladder cancer patients in relation to the chosen endpoints. We observed a high level of clinician engagement in using the ePROs and a positive impact on patients’ emotional functioning. Our study demonstrates the caveats in applying PROs across patient groups as a ...
PMC10562329
Acknowledgements
A special thanks to all the patients participating in this randomized study and all prior studies leading up to the current. Also, endless appreciation to the clinical and study staff at all four hospital sites throughout the study period.
PMC10562329
Author contributions
HL
RHD
GAT: Conceptualization; Data curation; Formal analysis; Funding acquisition; Investigation; Methodology; Project administration; Resources; Software; Validation; Visualization; Roles/Writing – original draft; Writing – review & editing. CJ: Conceptualization; Funding acquisition; Methodology; Resources; Supervision; Wr...
PMC10562329
Funding
Cancer
LARSEN, CANCER
Open access funding provided by Royal Library, Copenhagen University Library Danish Cancer Society, Dagmar Marshalls Fond, Einar Willumsens Mindelegat, A.P. Møller Lægefonden, Christian Larsen og Dommer Ellen Larsens Legat, Rigshospitalets Fond til støtte for onkologiske formal, Onkologisk Forskningsfond and Rigshospit...
PMC10562329
Availability of data and materials
The data that support the findings of this study are available from Gry Assam Taarnhøj but restrictions apply to the availability of these data, which were used under license for the current study, and so are not publicly available. Data are however available from the authors upon reasonable request and with permission...
PMC10562329
Declarations
PMC10562329
Ethics approval and consent to participate
The study was approved by the Danish Data Protection Agency (suite nb: RH-2017–348), registered at
PMC10562329
Consent for publication
Not applicable.
PMC10562329
Competing interests
The authors declare that they have no competing interests.
PMC10562329
References
PMC10562329
Background
cancer, anemia
CANCER, ANEMIA, BLOOD
Gynecologic cancer has a high frequency of anemia, which is associated with increased morbidity and mortality. Blood transfusion is used to correct anemia, but carries its own side effects and problems in the blood supply have been emerging. As such, methods other than transfusion are needed to correct anemia in patien...
PMC10359505
Primary Objective
anemia
GYNECOLOGIC CANCER, ANEMIA
To determine whether intravenous administration of high-dose iron supplements before and after surgery as a patient blood management program is helpful in correcting anemia and reducing the frequency of transfusion in patients with gynecologic cancer.
PMC10359505
Study Hypothesis
Patient blood management will reduce the transfusion rate by up to 25%.
PMC10359505
Trial Design
This prospective, multicenter, interventional, randomized controlled study will consist of three steps. In step 1, the safety and effectiveness of patient blood management for surgical patients before, during, and after surgery will be evaluated. In steps 2 and 3, the safety and effectiveness of patient blood managemen...
PMC10359505
Major Inclusion/Exclusion Criteria
gynecologic cancer
OVARIAN CANCER, ENDOMETRIAL CANCER, GYNECOLOGIC CANCER, IRON DEFICIENCY, CERVICAL CANCER
Patients who are diagnosed with gynecologic cancer (ie, endometrial cancer, cervical cancer, ovarian cancer) and scheduled for surgery will be included and their iron deficiency status will be assessed. Only those with a pre-operative hemoglobin level of 7 g/dL or higher will be included. Patients who underwent neoadju...
PMC10359505
Primary Endpoint
Rate of transfusion within 3 weeks after surgery.
PMC10359505
Sample Size
Eligible participants will be randomly assigned in a 1:1 ratio (167 patients each) into the patient blood management group and the conventional management group.
PMC10359505
Estimated Dates for Completing Accrual and Presenting Results
RECRUITMENT
Patient recruitment will be completed by mid-2025, and management and follow-up will be completed by the end of 2025.
PMC10359505
Trial Registration Number
PMC10359505
Introduction
cancer, Anemia, anemia
GYNECOLOGIC CANCER, CANCER, ACUTE BLOOD LOSS, SOLID TUMORS, ANEMIA, ANEMIA, BLOOD
Anemia is prevalent in cancer patients and affects 20–80% of patients with solid tumors.Gynecologic cancer is associated with a high frequency of anemia (~85%). The frequency of anemia and blood transfusion is also reported to be very high during surgery, chemotherapy, and radiation therapy, which are the mainstay of t...
PMC10359505
Methods and Analysis
PMC10359505
Trial Design
ONCOLOGY
This is a prospective, multicenter, interventional, comparative, randomized controlled trial involving a total of 15 institutions in South Korea, of which the Asan Medical Center (Seoul, South Korea) will serve as the leading institution. This study was approved by the institutional review board of Asan Medical Center ...
PMC10359505
Step 1: Anemia Correction in Surgery
anemia
BLOOD, ANEMIA
Blood tests will be performed between 2 and 6 weeks before surgery and anemia will be corrected according to the test results for each group as follows. The treatment and examination schedule for step 1 is shown in Examination and treatment of anemia in step 1 (surgery). Hb, hemoglobin; PBM, patient blood management; p...
PMC10359505
Patient Blood Management Group
HEMODYNAMIC INSTABILITY
If the hemoglobin level is between 7 g/dL and 12 g/dL in the preoperative blood test, 1000 mg of ferric carboxy-maltose will be administered between 2 and 6 weeks before surgery. During surgery, the need for transfusion will be decided according to the judgment of the attending surgeon and anesthesiologist in case of h...
PMC10359505
Conventional Management Group
Cancer
ONCOLOGY, HEMODYNAMIC INSTABILITY, COMPLICATIONS, CANCER
If the hemoglobin level is between 8 g/dL and 10 g/dL, one pack of RBC will be transfused and, if the hemoglobin level is 8 g/dL or less, two packs of RBC will be transfused. Erythropoietin and oral iron supplements will be allowed, but not intravenous iron supplements. During surgery, the need for transfusion will be ...
PMC10359505
Step 2: Anemia Correction in Adjuvant (Chemo)radiation Therapy
Anemia, anemia
ANEMIA, ANEMIA
Anemia will be corrected after performing blood tests on the day of computed tomography (CT) simulation, during (concurrent chemo-) radiation therapy ((CC)RT), and every 3 weeks (visit window±1 week) after the end of treatment. The hemoglobin level will be re-evaluated at 3 weeks after the end of treatment. The treatme...
PMC10359505
Patient Blood Management Group
If the hemoglobin level is between 7 g/dL and 12 g/dL in the pre-treatment blood test, 1000 mg of ferric carboxy-maltose will be administered; if the hemoglobin level is 7 g/dL or less, two packs of RBC will be transfused.
PMC10359505
Conventional Management Group
If the hemoglobin level is between 8 g/dL and 10 g/dL, one pack of RBC will be transfused; if the hemoglobin level is 8 g/dL or less, two packs of RBC will be transfused. Erythropoietin and oral iron supplements will be allowed but not intravenous iron supplements.
PMC10359505
Step 3: Anemia Correction in Adjuvant Chemotherapy
Anemia, anemia
ANEMIA, ANEMIA
Anemia will be assessed by performing blood tests the day before the start of chemotherapy and every two cycles during chemotherapy. The hemoglobin level will be re-evaluated at 3 weeks after the end of treatment. The treatment and examination schedule for step 3 is shown in Examination and treatment of anemia in step ...
PMC10359505
Patient Blood Management Group
If the hemoglobin level is between 8 g/dL and 12 g/dL in the pre-treatment blood test, 1000 mg of ferric carboxy-maltose will be administered; if the hemoglobin level is 8 g/dL or less, two packs of RBC will be transfused. Erythropoietin may be used in patients with a symptomatic hemoglobin level of 12 g/dL or less or ...
PMC10359505
Conventional Management Group
If the hemoglobin level is between 8 g/dL and 10 g/dL, one pack of RBC will be transfused; if the hemoglobin level is 8 g/dL or less, two packs of RBC will be transfused. Erythropoietin and oral iron supplements will be allowed but not intravenous iron supplements.
PMC10359505
Participants
PMC10359505
Inclusion Criteria
ovarian cancer
ONCOLOGY, OVARIAN CANCER
Study patients must satisfy all of the following selection criteria: (1) women aged 20–80 years; (2) untreated histologically diagnosed cervical cancer, endometrial cancer, or ovarian cancer (including cases diagnosed by imaging without biopsy in the case of ovarian cancer); (3) Eastern Cooperative Oncology Group perfo...
PMC10359505
Exclusion Criteria
allergic, tumor, cancer, non-melanoma skin cancer, cancer of the stomach and bladder
CANCER, TUMOR, IRON OVERLOAD, DISORDERS
The exclusion criteria are as follows: (1) unable to provide informed consent on their own; (2) allergic to existing iron preparations; (3) underwent neoadjuvant chemotherapy or pre-operative radiation therapy; (4) have had or received cancer treatment within 5 years, except for non-melanoma skin cancer, cervical intra...
PMC10359505
Endpoints
anemia
ADVERSE EVENTS, SECONDARY, ANEMIA
The primary endpoint is the rate of transfusion within 3 weeks after surgery. The secondary endpoints include transfusion rate within 3 weeks after radiation and chemotherapy, and the comparison of hemoglobin levels, frequency of anemia and blood transfusion before adjuvant therapy, frequency of delayed adjuvant therap...
PMC10359505
Sample Size
We performed sample size calculation through the Z-test with unpooled variance. Previous studies showed that the expected transfusion rate without patient blood management is 40%,
PMC10359505
Randomization and Blinding
cancer
CANCER
Patients will be randomly assigned in a 1:1 ratio to the patient blood management group and the conventional management group. A randomization table will be prepared using SAS software (SAS Institute, Cary, North Carolina, USA) by an independent statistician and study patients will be assigned using the stratified bloc...
PMC10359505
Statistical Methods
gynecologic cancer
GYNECOLOGIC CANCER
The main purpose of this study is to compare the transfusion rate according to the implementation of patient blood management in patients with gynecologic cancer undergoing surgery. For other safety endpoints such as laboratory tests and vital signs, continuous data will be presented using descriptive statistics (ie, m...
PMC10359505
Ethics statements
PMC10359505
Patient consent for publication
Consent obtained directly from patient(s)
PMC10359505
Ethics approval
This study involves human participants and was approved by the institutional review board of Asan Medical Center Approval ID: 2022-1674. Approval date December 6, 2022. Participants gave informed consent to participate in the study before taking part.
PMC10359505
References
PMC10359505
Background
type 2 diabetes
TYPE 2 DIABETES
The prevalence of type 2 diabetes is increasing among adolescents and clear strategies are needed to prevent it. The aim of this study was to determine the effect of peer education on knowledge, health beliefs and preventive behaviors of type 2 diabetes in female adolescents.
PMC10276363
Methods
AIDS
In this cluster randomized trial study, 168 students (84 people in each group) were enrolled. The data collection instrument was a questionnaire of knowledge (30 questions), health beliefs (16 questions) and behavior (20 questions) whose validity and reliability were confirmed. Then eight capable students were chosen a...
PMC10276363
Results
DISEASE
The result showed that the mean and standard deviation of general knowledge, disease symptoms, behavioral risk factors, mid-term outcomes and long-term outcomes, perceived self-efficacy, behavioral beliefs, perceived susceptibility, perceived severity, prevention of stress, healthy food/healthy diet, unhealthy food/unh...
PMC10276363
Conclusions
diabetes
DIABETES
Peer education increased knowledge and improved adolescents' health beliefs and behaviors. Therefore, training in adolescence in order to prevention of diabetes can be considered as an effective step, and the use of peer-led education in this field is recommended.
PMC10276363
Trial registration
Trial registration number IRCT20200811048361N1 from School of Public Health & Neuroscience Research Center—Shahid Beheshti University of Medical Sciences. Date applied: 30/12/2020. Date assigned: 01/12/2020.
PMC10276363
Keywords
PMC10276363
Background
death, type-2 diabetes, Type-2 diabetes, Diabetes, chronic and metabolic disease
DISEASE, COMPLICATIONS, DIABETES
Diabetes is a chronic and metabolic disease with high levels of blood sugar that leads to several complications [In addition, this serious disease is witnessed as a new clinical condition among children. There has been a surge in the number of type-2 diabetics among children and adolescents across all ethnic groups [In...
PMC10276363
Materials & methods
PMC10276363
Dates periods of recruitment
Participants were enrolled from July 2021 to October 2021 and participated in the intervention from November 2021 to April 2022.
PMC10276363
Study design and sampling
In this cluster randomized trial study, was performed in Tehran. 168 eighth grade female students (84 students in the intervention group and 84 in the control group) based on their interest and informed consent and their Parents written informed consent participated in the study in 2021.Initially, 14 district (a downto...
PMC10276363
Sample size
Since, the standard deviation of the study variables was not known to the researcher, therefore based on the following formula, [
PMC10276363
Eligible criteria
PMC10276363
Inclusion criteria
type-1 or type-2 diabetes
• Students’ willingness for participation• Not suffering from type-1 or type-2 diabetes
PMC10276363
Exclusion criteria
Reluctance to participate in the study at any stage.
PMC10276363
Data collection tools
Researcher-made questionnaire was used as data collection tool:
PMC10276363
Designing the instrument:
1. Systematic review of literature and the relevant instruments: 38 questionnaires, 42 research papers, and 10 theses were consulted to design the questionnaire.2. Determining and designing the items of the instrument through the existing documents, papers, and questionnaires in Iran and other countries: Relevant ques...
PMC10276363
Reliability and validity
DISEASE
The tool’s validity was checked by face, content and construct validity. To determine face validity, the questionnaire was completed by 20 students. Content validity of the questionnaire was confirmed by qualitative and quantitative methods. In quantitative content analysis, Content Validity Ratio (CVR) and Content Val...
PMC10276363
Intervention
type-2 diabetes, diabetes
DISEASE, TYPE 2 DIABETES, DISEASES, COMPLICATIONS, DIABETES
The educational intervention was through peer education. Peer education has been employed as an effective strategy to combat diseases around the globe. Accordingly, people with shared characteristics such as age, gender, culture, education, and place of residence are assigned the task of imparting information with the ...
PMC10276363
Data analysis
In this study Chi-square was used to check the homogeneity of samples as well as the consistency of contributing demographic factors in the research.To check the normality of the data, Skewness and Kurtosis (In interval 2, -2) were calculated. Also, the ANCOVA was performed considering some of assumption, for example: ...
PMC10276363
Results
This study was conducted on 168 female students in the 14-year-olds age group. See the study steps in the CONSORT diagram (Fig. The participants' descriptive characteristics are listed in Table Demographic variables in intervention and control groups before the interventionIn the intervention group, almost three quarte...
PMC10276363
Discussion
type-2 diabetes, ’ behavior, diabetes
COMPLICATIONS, DIABETES
The main purpose of this research study was to determine the effect of peer education on knowledge, attitude, and preventive measures against type-2 diabetes among female adolescents. The results show that the peer educational intervention had positive effects on adolescents’ knowledge. Banerjeea et al. also witnessed ...
PMC10276363
Implications
type-2 diabetes
TYPE 2 DIABETES
A firm action to take in the prevention of type-2 diabetes is keeping adolescents under control in every place where they spend their time. School setting is considered crucial in promoting and implementing positive changes to adolescents’ habits School health strategies are a critical component of multidisciplinary an...
PMC10276363
Limitations and strengths
The limitations of the study include impossibility of assessing the long-term effect of the intervention, individual’s responses to the questions. Another limitation of the study was self-report in response to behavioral questions (instead of objective observation), also since the questionnaire has been validated inter...
PMC10276363
Conclusion
Type 2 diabetes, diabetes
TYPE 2 DIABETES, TYPE 2 DIABETES, DIABETES
The results of the study show that educational intervention of School-based within peer education framework can contribute to enhanced knowledge and Improve health beliefs and behaviors among female students. Applying this study to a similar population may reduce the risk of Type 2 diabetes in them.Therefore, implement...
PMC10276363