title stringlengths 1 1.19k | keywords stringlengths 0 668 | concept stringlengths 0 909 | paragraph stringlengths 0 61.8k | PMID stringlengths 10 11 |
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Management of safety events | EVENTS | The responsibility for collecting and assessing safety events in this study fell to the blinded investigator, who made determinations of causality based on the five principles of adverse event-drug causality assessment [ | PMC10636892 | |
Discussion | operability | SEPARATION | In the present study, there were two independent evaluations of each subject at different time points of the visit after treatment, which can be considered a sample size of 22. If we assume that Kappa=0.7 represents a better agreement, while we evaluated the blinded and non-blinded state, we found Kappa=0.248 (about 0.... | PMC10636892 |
Conclusions | In open clinical studies, minimizing information bias represents a significant challenge. Our findings indicate that implementing blinded evaluations can effectively reduce information bias, thereby ensuring the authenticity and reliability of trial outcomes. We strongly advocate for the appointment of an independent b... | PMC10636892 | ||
Acknowledgements | We thank the investigators and participants for making this research possible. | PMC10636892 | ||
Authors’ contributions | The study was designed by the authors (RG, FL, QL ). Data was collected by the authors (HZ, YY, PQ). Data was analyzed by the authors (MX, YZ). XL provided language editing and revision. The first version of the manuscript was written by QL; all authors revised the manuscript. | PMC10636892 | ||
Funding | This work was supported by the “National Key R&D Program of China” and “Science and Technology Innovation Project of the Chinese Academy of Traditional Chinese Medicine” (No.2019YFC1709300 and No. CI2021A04704). | PMC10636892 | ||
Availability of data and materials | The datasets will be made available after a reasonable request to the investigator of the Institute of Clinical Pharmacology, Xiyuan Hospital, Chinese Academy of Traditional Chinese Medicine. | PMC10636892 | ||
Declarations | PMC10636892 | |||
Ethics approval and consent to participate | The IRB approved this study of Xiyuan Hospital of China Academy of Chinese Medical Sciences (No. 2022XLA093-1). Prior to taking part in the trial, informed consent was obtained from all participants and/or their legal guardian(s). | PMC10636892 | ||
Consent for publication | All consent forms included permission for publication of any information gained through the individual’s participation. | PMC10636892 | ||
Competing interests | The authors declare that they have no competing interests. | PMC10636892 | ||
References | PMC10636892 | |||
Objective | diabetes, Diabetes | DIABETES, DIABETES | Edited by: Martha M. Funnell, University of Michigan, United StatesReviewed by: Linda Siminerio, University of Pittsburgh, United States; Kevin Joiner, School of Nursing, University of Michigan, United StatesThis article was submitted to Clinical Diabetes, a section of the journal Frontiers in Public HealthTo evaluate ... | PMC9998510 |
Methods | TYPE 2 DIABETES | The DiaBEAT-it study employed a hybrid 2-group preference (Choice) and 3-group randomized controlled (RCT) design. This paper presents weight related primary outcomes of the RCT arm. Patients from Southwest Virginia were identified through the Carilion Clinic electronic health records. Eligible participants (18 and old... | PMC9998510 | |
Results | Of the 334 participants that were randomized, 232 (69%) had study measured weights at 6 months, 221 (66%) at 12 months, and 208 (62%) at 18 months. Class/IVR participants were less likely to complete weight measures than SC or DVD/IVR. Intention to treat analyses, controlling for gender, race, age and baseline BMI, sho... | PMC9998510 | ||
Conclusions | obesity, diabetes | OBESITY, DIABETES | The DiaBEAT-it interventions show promise in responding to the need for scalable, effective methods to manage obesity and prevent diabetes in primary care settings that do not over burden primary care clinics and providers. | PMC9998510 |
1. Introduction | T2D, prediabetes, Diabetes, weight loss, diabetes | DIABETES, DISEASE, PREDIABETES, DIABETES | The Centers for Disease Control and Prevention (CDC) estimates that there are 34.2 million (10.5%) Americans with diabetes, in addition to the 88 million (34.5% of the population) with prediabetes in the United States, and strongly recommends healthcare approaches to prevent diabetes (The Diabetes Prevention Program (D... | PMC9998510 |
2. Design and methods | diabetes | DIABETES | Patients at risk for developing diabetes were randomly assigned (2-1) by the project manager to either an RCT or Choice study arm using a blocked (groups of 4) randomization table stratified by sex created by the study statistician. Patients in the RCT arm were further randomized (1-1-1) to one of three groups: (1) a 2... | PMC9998510 |
2.1. Participant eligibility and recruitment | BLIND | Potential participants were initially identified through a Carilion Clinic electronic health records (EHR) query of primary care patients between January 2014 and August 2015 (Individuals were eligible if they were 18 years of age or older with a BMI of at least 25 kg/mPrior to the baseline visit, the project manager c... | PMC9998510 | |
2.2. Interventions | PMC9998510 | |||
2.2.1. Standard care | Participants in the SC comparison group took part in a 2-h small group session class ( | PMC9998510 | ||
2.2.2. Class/IVR group | Participants in this group attended the 2-h class described above, received a workbook, completed a “Live” counseling call ( | PMC9998510 | ||
2.2.3. DVD/IVR group | diabetes | PRE-DIABETES, DIABETES | This group was identical to the Class/IVR group but was initiated with a DVD that replicated the class content. The DVD included the following segments: (1) What is pre-diabetes? (2) What are the risk factors for diabetes? (3) Developing your DiaBEAT-it action plan, (4) Goal setting for physical activity and healthy ea... | PMC9998510 |
2.3. Outcome measures | weight loss, weight reduction | Trained research assistants unaware of group assignment collected data at baseline, 6, 12, and 18 months. The primary outcome was change in BMI from baseline to 18 months. Secondary outcomes included percentage of participants achieving weight loss goals of 5% or more, changes in percent weight reduction as well as mai... | PMC9998510 | |
2.4. Statistical analysis | Diabetes | DIABETES | Statistical analysis included descriptive statistics for age, sex, race, ethnicity, education, income, health literacy, employment, health insurance, Diabetes Risk Calculator (DRC), and weight status. Chi-square and independent Additionally, we conducted analysis based on participants completing at least 4 sessions (i.... | PMC9998510 |
3. Results | PMC9998510 | |||
3.3. Intervention participation rates: CDC recognition standards | weight loss | On average participants in the DVD/IVR group completed 15.5 (±8.6) sessions compared to 14.1 (±8.3) for Class/IVR. Approximately, 86.3% of participants in the intervention groups (DVD/IVR: 86.6%; Class/IVR: 86%) met the CDC threshold of completing at least 4 sessions with 48.4% (DVD/IVR: 52.6%; Class/IVR: 44%) staying ... | PMC9998510 | |
3.3.1. Adverse events | allergic reactions–21, neoplasms, infections, cardiac disorders, vascular disorders, nervous systems disorders | ADVERSE EVENTS, NEOPLASMS, RESPIRATORY DISORDERS, INFECTIONS, DISORDERS, CARDIAC DISORDERS, IMMUNE SYSTEM DISORDER, MUSCULOSKELETAL DISORDERS, VASCULAR DISORDERS, EVENTS, COMPLICATIONS | During the trial, 40 adverse events (AE) were reported; 6 were classified as serious adverse events (SAE). The majority were associated with immune system disorders (allergic reactions–21). Additional categories included cardiac disorders (1), musculoskeletal disorders (3), general disorders (1), infections (1), injury... | PMC9998510 |
4. Discussion and conclusion | obesity, Obesity, T2D, Diabetes, weight loss, diabetes | OBESITY, DIABETES, OBESITY, DIABETES | The randomized control trial arm of our study demonstrated that two technology-enhanced diabetes prevention programs both led to modest reductions in body weight over an 18-month period. Most importantly, the DVD/IVR group showed significant reductions in BMI when compared to the SC group confirming our original hypoth... | PMC9998510 |
Data availability statement | The raw data supporting the conclusions of this article will be made available by the authors, without undue reservation. | PMC9998510 | ||
Ethics statement | The studies involving human participants were reviewed and approved by Carilion Clinic Institutional Review Board. The patients/participants provided their written informed consent to participate in this study. | PMC9998510 | ||
Author contributions | Camilia, RS | BROWN | FA, WY, RS, BD, MG, JH, and PE contributed to the conception of the protocol and study design. FA, WY, FB, TA, CG, and SW were involved with the data collection and analysis. All authors were involved in writing the paper and had final approval of the submitted manuscript.The authors would like to acknowledge the entir... | PMC9998510 |
Conflict of interest | The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. | PMC9998510 | ||
Publisher's note | All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article, or claim that may be made by its manufacturer, is not guaranteed or ... | PMC9998510 | ||
Supplementary material | The Supplementary Material for this article can be found online at: Click here for additional data file. | PMC9998510 | ||
References | PMC9998510 | |||
Background | asthma-like symptoms, wheezing, asthma, exhaled breath, wheeze | ASTHMATIC, ASTHMA | The prevalence of asthma-like symptoms in preschool children is high. Despite numerous efforts, there still is no clinically available diagnostic tool to discriminate asthmatic children from children with transient wheeze at preschool age. This leads to potential overtreatment of children outgrowing their symptoms, and... | PMC10068201 |
Methods | allergic sensitisation, asthma, wheeze, exhaled breath | DISEASE, ASTHMA | This study is a combination of a multi-centre, parallel group, two arm, randomised controlled trial and a multi-centre longitudinal observational cohort study. The preschool children randomised into the treatment arm of the RCT receive a probability diagnosis (and corresponding treatment recommendations) of either asth... | PMC10068201 |
Discussion | asthma-like symptoms, wheezing, asthma | ASTHMA | The potential societal and clinical impact of the diagnostic tool for wheezing preschool children is substantial. By means of the breath test, it will become possible to deliver customized and high qualitative care to the large group of vulnerable preschool children with asthma-like symptoms. By applying a multi-omics ... | PMC10068201 |
Trial registration | Netherlands Trial Register, NL7336, Date registered 11–10-2018. | PMC10068201 | ||
Keywords | PMC10068201 | |||
Background | cough, breathlessness, wheeze | Respiratory symptoms, such as wheeze, breathlessness, chronic cough, and sputum production, are very common in young children. Around 40% of all children under the age of 6 suffer from these asthma-like symptoms [ | PMC10068201 | |
Prediction of asthma in the guidelines | asthma-like symptoms, asthma, wheeze | ASTHMA | The prediction of asthma in preschool children with asthma-like symptoms (such as wheeze) has been an important unresolved topic. A reliable asthma diagnosis in preschool wheeze is not possible, as noted by the various (inter)national asthma guidelines [ | PMC10068201 |
Wheezing phenotypes and clinical predictive indices | asthma, wheeze | THORACIC, ASTHMA | Whilst no tests diagnose asthma with certainty, various attempts were done to improve an asthma diagnosis in young children. For example, different phenotypes have been described based on triggers of wheeze obtained by clinical history, including episodic (viral) wheeze and multi-trigger wheeze. This was adopted by the... | PMC10068201 |
Consequences of an absent diagnostic instrument for an early diagnosis in wheezing children | palpitations, tremor, wheezing, underdiagnosis, asthma, wheeze | ASTHMA | In current clinical practice, the absence of a proper diagnostic test for an early asthma diagnosis in young children leads to at least 2 major health problems: 1) children with asthma are frequently underdiagnosed and undertreated; 2) children with transient wheeze are often overtreated with asthma medication.Consider... | PMC10068201 |
Volatile organic compounds | exhaled breath | Over the past decades, exhaled breath has evolved as a new bodily matrix that has great potential for diagnostic and monitoring purposes [ | PMC10068201 | |
A predictive breath test for asthma in preschool children | wheezing, asthma, exhaled breath | ASTHMA, ASTHMA | In 2015 we published the results of a longitudinal study in 202 wheezing children, in which we assessed the potential of exhaled breath biomarkers for a paediatric asthma diagnosis, called the ADEM study (Asthma DEtection and Monitoring study) [the chemical identity of the 9 most predictive VOCs of the ADEM algorithm. ... | PMC10068201 |
VOCs-sensing techniques in daily clinical practice | In the ADEM study, we used gas chromatography– | PMC10068201 | ||
Pathophysiological mechanisms | asthma, airway inflammation, asthma [ | DISEASE, OXIDATIVE STRESS, ASTHMA | Although the assessment of VOCs is attractive by the non-invasive nature, there is limited understanding of their origin in asthma. VOCs can be formed during various pathophysiological processes, such as airway inflammation and oxidative stress, induced by host and coexisting micro-organisms. Analysing the underlying m... | PMC10068201 |
Objectives of the new study: the ADEM2 study | wheezing, asthma, exhaled breath | PATHOGENESIS, ASTHMA | The previous ADEM study generated a lot of insight in the diagnostic potential of VOC patterns in exhaled breath with respect to an early diagnosis of asthma, and in multiple potential underlying pathophysiological mechanisms leading to the development of asthma. However, since then, many new questions arose. For examp... | PMC10068201 |
Hypotheses of the ADEM2 study | exacerbations, airway remodelling, asthma-like symptoms, wheezing, allergy, asthma, wheeze | ALLERGY, ASTHMA, SEQUELA | The hypothesis of the clinical trial of the ADEM2 study is that application of the breath test in preschool children with asthma-like symptoms will result in important health gain and reduction of costs of care. In children with asthma, we expect that an early diagnosis by the breath test will result in more targeted a... | PMC10068201 |
Methods | PMC10068201 | |||
Study design | The proposed study is a combination of a multi-centre, parallel group, two arm, randomised controlled trial and a multi-centre longitudinal observational cohort study. All children that participate in the RCT will also contribute to the observational cohort study.I | PMC10068201 | ||
Study setting | Preschool | DISEASE | In order to achieve a good mixture of disease variability and severity in the study population (to maximise the external validity of the study results), the trial will be conducted in primary care practices and in the paediatric wards and outpatient departments of several general hospitals and university hospitals in t... | PMC10068201 |
Eligibility criteria | wheezing | The proposed study protocol includes both wheezing preschool children and healthy preschool children. In the RCT only wheezing preschool children will participate, whereas in the longitudinal cohort study both wheezing and healthy preschool children participate. | PMC10068201 | |
Inclusion criteria | shortness of breathHealthy, wheezing, Wheezing |
Wheezing children: age between 2 and 4 years old and presence of two or more objectified (by a physician or nurse) episodes of wheezing and shortness of breathHealthy children: age between 2 and 4 years old | PMC10068201 | |
Exclusion criteria | kidney or liver disease, Wheezing, prematurity, congenital lung disease, auto-immune disorders, asthma, wheeze, mental disability | CARDIAC DISEASE, ASTHMA, INFLAMMATORY DISEASE, INFLAMMATORY BOWEL DISEASE |
Wheezing children: presence of chronic and/or inflammatory disease other than asthma (e.g. inflammatory bowel disease, auto-immune disorders, cardiac disease, congenital lung disease, kidney or liver disease), prematurity < 35 weeks gestational age, postnatal need for oxygen, CPAP, non-invasive or invasive ventilation... | PMC10068201 |
Intervention | asthma, wheeze | ASTHMA | The intervention in the RCT consists of providing a probability diagnosis of either asthma or transient wheeze based on the earlier developed breath test of the ADEM study [ | PMC10068201 |
Outcomes | PMC10068201 | |||
Randomised controlled trial | asthma-like symptoms |
Primary outcome: difference between the intervention group and the usual care group in the percentage of well controlled asthma-like symptoms after 1- and 2-year follow-up. The percentage well controlled asthma-like symptoms will be based on the validated TRACK questionnaire.Secondary outcomes: differences after one y... | PMC10068201 | |
Prospective cohort study | allergic sensitisation, asthma, wheeze | DISEASE, ASTHMA |
Secondary outcomesThe sensitivity and specificity of new VOC sensing techniques (e.g. SIFT-MS and VOC sensors) for a diagnosis of asthma or transient wheeze in preschool children. Assessment at the start of the study in relation to the current gold standard in breath research (GC–MS) and at the age of 6 years in relat... | PMC10068201 |
Participant timeline | wheezing | Both wheezing participants and healthy participants follow the same timeline (Fig. Flow of participantsSchedule of enrolment, interventions, and assessments. * Children can enrol the study at 2 or 3 years of age. ** Only applicable for patients enrolling the study at 2 years of ageSchedule of questionnaires. | PMC10068201 | |
Recruitment | Wheezing | RECRUITMENT | Wheezing participants will be recruited at the participating primary care centres and participating hospitals. Potential candidates will be identified by their treating physicians and (specialised) nurses at the primary care practices, outpatient departments, paediatric wards or emergency departments during the recruit... | PMC10068201 |
Allocation and blinding | wheezing, CTCM | SECONDARY, RECRUITMENT | The wheezing preschool children that participate in the RCT will be randomly assigned (1:1), with a secure computer-generated block randomisation procedure (block size of 6), into a usual care group and an intervention group. The randomisation will be organised by the Clinical Trial Centre Maastricht (CTCM) and MEMIC (... | PMC10068201 |
Data collection | During the annual visits, various study procedures will be conducted. Each centre in which the study visits take place (the “measurement centres”) has a dedicated team consisting of one or two research nurses, and one or two p that execute all study-related procedures. All study personnel will be trained in the study r... | PMC10068201 | ||
Buccal swab | asthma | ASTHMATIC, MINOR, ASTHMA | Isohelix Buccal swabs with RapiDri™ pouch will be used to sample buccal cells for isolating DNA at the baseline visit. The extracted DNA is used to study gene polymorphisms in selected candidate genes. The inclusion of genes for SNP analysis is based on the following criteria: association with asthma based on biomedica... | PMC10068201 |
Nasal epithelial brush | STERILE | Nasal epithelial cells will be collected at the baseline visit by brushing nylon flocked swabs (FLOQSwabs®, COPAN, CA, USA) against the lateral side of the inferior turbinate of both nostrils. Two swabs will be transferred into sterile National Lab Cryovials, and two swabs will be transferred into sterile National Lab ... | PMC10068201 | |
Venous blood sample | inflammation, wheeze | BLOOD, OXIDATIVE STRESS, STERILE, INFLAMMATION | Six millilitres of venous blood will be sampled at baseline visit and at the end visit. One to two hours prior to the blood puncture, lidocaine 1% gel with 4 × 4 cm plaster will be applied. This blood will be used for.allergy testing: total immunoglobulin E (IgE) and determination of specific IgE antibodies to inhalant... | PMC10068201 |
API and modified API (mAPI) | atopy, wheezing, asthma, eczema | ATOPY, ALLERGIC RHINITIS, ASTHMA, COLDS, ECZEMA | The API and mAPI (based on parental asthma, eczema, allergic rhinitis, wheezing apart from colds, and atopy) will be assessed at baseline [ | PMC10068201 |
Cost-effectiveness | DISEASE | Cost-effectiveness will be calculated as the incremental costs per child with well-controlled disease (based on the TRACK questionnaire) and incremental costs per quality-adjusted life year (QALY) (based onEQ-5-DY). | PMC10068201 | |
Pharmacotherapy | asthma | DISEASE, ASTHMA | Use of asthma medication and antibiotics will be continually registered: drugs, dosage, and period of use. Parents will be asked to register this using the app “Qdot studies” developed by Maastricht University. This app is specifically designed to collect data for scientific studies through questionnaires. We will asse... | PMC10068201 |
Exacerbation of wheezing | exacerbations of asthma-like symptoms | Parents will be asked to register all exacerbations of asthma-like symptoms. This is facilitated by the same mobile application as is used for registration of pharmacotherapy. | PMC10068201 | |
Growth | Weight and height will be assessed in height standard deviation (SD) z-scores according to national growth data. Height velocity will be calculated. | PMC10068201 | ||
Asthma or transient wheeze diagnosis at 6 years | wheeze, asthma | ASTHMA | The final diagnosis of transient wheeze or asthma will be made by two paediatric pulmonologists after the clinical visit at the age of 6 years. These paediatric pulmonologists will be blinded for the probability diagnosis (if applicable) of the participants. The asthma diagnostic algorithm for children as published by ... | PMC10068201 |
Assessment of differences in asthma control between the intervention group and the usual care group in the percentage of well controlled asthma-like symptoms after 1- and 2-year follow-up. | asthma | ASTHMA, ASTHMA | The effect of the intervention on asthma control will be assessed by comparing the outcome measures between the intervention and the usual care group in the RCT. Asthma control will be scored using the validated TRACK questionnaire. Differences of the continuous outcome measure between the intervention group and the us... | PMC10068201 |
Assessment of improvement in health gain and costs of care with the application of the breath test in wheezing preschool children | asthma-like symptoms | The effect of the intervention will be assessed by comparing the outcome measures between the intervention and the usual care group in the RCT. Dichotomous parameters will be tested with the chi-square test. Continuous variables will be tested for significance with the unpaired t-test for normally distributed parameter... | PMC10068201 | |
Assessment accuracy of the VOC sensing techniques (GC-tof–MS, SIFT-MS) | The primary outcome of the prospective cohort study is assessed in two ways, namely by comparing the VOCs data of the two VOCs-sensing techniques (GC- | PMC10068201 | ||
Assessment of pathogenic pathways in the early development of asthma | SECONDARY | The secondary outcomes of the prospective cohort study will be assessed by an integrative omics approach. The high dimensional multi-omics data require advanced statistical analyses. We will use machine learning and multi-variate statistical approaches (such as elastic net and weighted gene co-expression network analys... | PMC10068201 | |
Data monitoring and management | CTCM, CRF | CRF | Despite the fact that this study will be conducted in a paediatric population, the implementation of a Data Management Committee is not indicated. This decision was mainly based on the fact that the intervention of the study (probability diagnosis based on the breath test) provides caregivers and treating physicians wi... | PMC10068201 |
Auditing | Independent review of core trial processes and documents will be executed through periodic, scheduled, on-site, monitoring visits. Processes such as participant enrolment, consent, eligibility, allocation to study groups, adherence to trial interventions, policies to protect participants, and completeness and accuracy ... | PMC10068201 | ||
Ethics | wheezing | RECRUITMENT | NL64912.068.18 (11Both wheezing children and healthy children will be invited through an invitation letter combined with the Subject Information (see section on recruitment for more details). Parents are encouraged to contact the study team in case of any questions. We will ask the parents, if they decide to participat... | PMC10068201 |
Confidentiality and access to data | wheezing | DISEASE | Data will get a code and will be handled confidentially in accordance with the General Data Protection Regulation (GDPR). The code is based on an unique participant number, the disease status (healthy versus wheezing participants), and the centre and region where the participant comes from. Our secured, web-based study... | PMC10068201 |
Public disclosure and publication policy | POSITIVE | We will comply with the ‘CCMO statement publication policy’. Positive as well as negative findings will be published. After completion, the study results will be made known to the CCMO and the public. | PMC10068201 | |
Biological specimens | All biological specimens (faeces, blood, nasopharyngeal swabs, buccal swabs for DNA extraction, nasal swabs) will be coded and stored in the BioBank Maastricht UMC + and the UMCG for 10 years. These specimens will be used for the current trial and may be used for future research questions or analyses of new biomarkers.... | PMC10068201 | ||
Discussion | wheezing, asthma, wheeze | ASTHMA | In this study protocol we described the assessment of the three main objectives of the ADEM2 study: with respect to the first objective, a multicentre RCT will be performed to assess the potential gain in health and reduction of health care related costs by means of a proper early diagnosis through the breath test in w... | PMC10068201 |
Relevance and societal and clinical impact | asthma-like symptoms | The potential societal and clinical impact of the diagnostic tool for the children and the relevance of the project is substantial. By means of the breath test, it will become possible to deliver high qualitative care to the large group of vulnerable children with asthma-like symptoms, which will be more effective, saf... | PMC10068201 | |
Methodological issues | asthma-like symptoms, wheezing, exacerbations | RECRUITMENT | We decided to choose a RCT design for the following reasons: 1) to assess the full potential of the breath test in health gain and costs of care, a comparative study design is needed; 2) the breath test is not standard care yet; 3) in the usual care group, it is not unethical to provide the test result in a later phase... | PMC10068201 |
Feasibility of implementation | asthma-like symptoms | LUNG | The current breath test is based on GC-It is our goal to implement a breath test at all levels of care: from primary care (general practitioner offices) to regional hospitals (with general paediatric care) and academic hospitals (with paediatric pulmonologists). The breath test will certainly help to overcome the probl... | PMC10068201 |
Health gain and cost saving | asthma, wheeze, exacerbations | ASTHMA | The health gain will directly arise as a consequence of a higher proportion of children with asthma control. Furthermore, a considerable annual cost-saving might occur because of reduced referrals and hospital visits after a diagnosis of transient wheeze is established. Not included in the calculations are positive qua... | PMC10068201 |
Insights in pathogenic mechanisms in the early development of asthma | wheezing, asthma, wheeze | ASTHMA | With our multi-omics approach we expect to unravel important pathogenic pathways in the early development of asthma and transient wheeze. We will apply genomics, transcriptomics of blood and nasal epithelium, microbiomics, epigenetics, and metabolomics to establish an integral pathogenic mechanisms for the early develo... | PMC10068201 |
Conclusion | wheezing, asthma, wheeze | ASTHMA | In summary, the ADEM2 project covers 3 main areas. First, a multicentre RCT will be performed to assess the hypothesised gain in health and reduction of health care related costs by means of a proper early diagnosis using the breath test in wheezing preschool children. Second, the longitudinal observational cohort stud... | PMC10068201 |
Acknowledgements | We would like to thank Karen Groot for her extensive help in organising the ADEM2 project. | PMC10068201 | ||
Authors’ contributions | ED, OvS, and RJ initiated the research project. ED, OvS, RJ, MB, SK, FvS and AS designed the randomized controlled trial and observational cohort study protocol. AS and FvS developed and reviewed the VOC-based breath test analysis. GK and EK developed the genomic analysis. JD initiated and facilitated the collaboration... | PMC10068201 | ||
Funding | LUNG | The ADEM2 study is supported by The Netherlands Organisation for Health Research (ZonMW) (project number 848101008), a Netherlands Lung Foundation Grant (project number 6.1.18.221), and two grants of Top Sector Life Sciences and Health Health (TKI Topconsortia voor Kennis en Innovatie) (project number 10.1.17.183 and L... | PMC10068201 | |
Availability of data and materials | Not applicable. | PMC10068201 | ||
Declarations | PMC10068201 | |||
Ethics approval and consent to participate | LUNG | Ethical approval is obtained from the accredited Medical Research Ethics Committee (MREC) Academic Hospital Maastricht / University Maastricht. Also, the study protocol is extensively studied by the funding organizations: Netherlands Lung Foundation, The Netherlands Organisation for Health Research and Development (Zon... | PMC10068201 | |
Consent for publication | Consent for publication of Fig. | PMC10068201 | ||
Competing interests | The authors declare that they have no competing interests. | PMC10068201 | ||
References | PMC10068201 |
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