PROactive Cohort Study

Citation Metadata

Persistent Identifier	doi:10.34894/FXUGHW
Publication Date	2021-06-14
Title	PROactive Cohort Study: Data
Author	Nijhof, Sanne (University Medical Center Utrecht) - ORCID
	Putte, Elise van de (University Medical Center Utrecht) - ORCID
	Hoefnagels, Johanna Wilhelmina (University Medical Center Utrecht) - ORCID
Point of Contact	Hoefnagels, Johanna Wilhelmina (University Medical Center Utrecht)
	Nijhof, Sanne (University Medical Center Utrecht)
	Generic Mailbox - Datamanagement WKZ (University Medical Center Utrecht)
Description	Children with a chronic disease face more obstacles than their healthy peers, which may impact their physical, social-emotional, and cognitive development. In the long run, children with a chronic disease reach developmental milestones later than their healthy peers and many children will remain dependent on medication and/ or will be limited in their daily life activities. The PROactive Cohort Study aims to assess fatigue, participation, and psychosocial well-being across children with various chronic diseases over the course of their lifespan since their increased vulnerability is a fact. These factors have the potential to influence their identity and how they grow into autonomous adults that take part in our society. Also the PROactive Cohort Study is aimed at supporting people with chronic and/or life-threatening conditions to increase their ability to adapt, and their self-manage capacities. This means that PROactive also systematically monitors the child’s capacity and ability to play and the well-being of the patients and their families. This knowledge can be used as an innovative and interactive method for creating prevention and treatment strategies. This will help to assess vulnerabilities and resilience among children with chronic and/or life-threatening conditions and their families. This cohort study follows a continuous longitudinal design. It is based at the Wilhelmina Children’s Hospital in the Netherlands and has been running since December 2016. Children with a chronic disease (e.g. cystic fibrosis, juvenile idiopathic arthritis, chronic kidney disease, or congenital heart disease) in a broad age range (2-18 years) are included, as well as their parent(s). Patient-reported outcome measures (PROMs) are collected from parents (children between 2-18 years) and children (8-18 years). The PROactive Cohort Study uses a flexible design in which the research assessment is an integrated part of clinical care. Children are included when they visit the outpatient clinic and are followed up annually, preferably linked to another outpatient visit. (2021-05-07)
Subject	Medicine, Health and Life Sciences; Social Sciences
Keyword	Child Health (MeSH)
	Chronic Disease (MeSH)
	Lifecycle Paediatrics
	Biopsychosocial Model (MeSH)
	PROactive
Related Publication	der Vlist, M. M. N., Hoefnagels, J. W., Dalmeijer, G. W., et al. The PROactive cohort study: rationale, design, and study procedures. European Journal of Epidemiology (2022). https://doi.org/10.1007/s10654-022-00889-y
	Nijhof, S., Hoefnagels, J. W., der Vlist, M. N., & Moopen, N. (2023, August 16). PROactive Cohort Study: Scripts. https://doi.org/10.17605/OSF.IO/3U4QZ
	Nap-van der Vlist, M. M., Dalmeijer, G. W., Grootenhuis, M. A., van der Ent, K., van den Heuvel-Eibrink, M. M., Swart, J. F., van de Putte, E. M., & Nijhof, S. L. (2021). Fatigue among children with a chronic disease: a cross-sectional study. BMJ Paediatrics Open, 5(1). https://doi.org/10.1136/bmjpo-2020-000958
	Nap-van der Vlist, M. M., Burghard, M., Hulzebos, H. J., Doeleman, W. R., Heijerman, H. G., van der Ent, C. K., & Nijhof, S. L. (2018) Prevalence of severe fatigue among adults with cystic fibrosis: a single center study. Journal of Cystic Fibrosis, 17(3), 368-374. https://doi.org/10.1016/j.jcf.2018.03.003
Language	Dutch; English
Production Location	Utrecht, The Netherlands
Contributor	Hosting Institution : University Medical Center Utrecht
	Researcher : Nijhof, Sanne
	Researcher : Putte, Elise van de
	Researcher : Hoefnagels, Johanna Wilhelmina
	Researcher : Nap-van der Vlist, Merel
	Data Manager : Moopen, Neha
Depositor	Moopen, Neha
Deposit Date	44323
Date of Collection	Start Date: 2016-12-01
Data Type	clinical data; patient reported outcome; proxy reported outcome
Software	SPSS, Version: 26
Related Dataset	A comparable dataset, including pediatric post oncology data, is available at the Princess Maxima Center (PMC), Utrecht, The Netherlands. The contact person is prof. dr. Martha Grootenhuis (M.A.Grootenhuis-5@umcutrecht.nl).

Social Sciences & Humanities Metadata

Unit of Analysis	Individual; Family
Universe	Children (aged between 2-18) with a chronic condition, and their parents. The participants are all residents in the Netherlands.
Time Method	cross-sectional, longitudinal
Frequency	Yearly
Sampling Procedure	Participants are screened for inclusion into the study when visiting the outpatient clinic. If included, the children and their parents complete questionnaires on psychosocial functioning. These questionnaires are primarily utilized within the context of clinical care, but they are used in scientific research if consent is provided for the same.
Collection Mode	online questionnaires (KLIK; https://www.hetklikt.nu/)
Type of Research Instrument	Structured, with some open-ended questions.
Characteristics of Data Collection Situation	Parents and children have their own user profiles for the questionnaires. This means they cannot view each others’ responses, but researchers can easily link these users during data export. Participants complete the questionnaires at home, on a computer. The estimated time participants need to complete all questionnaires was 30-45 minutes for a baseline or extended assessment and 15-20 minutes for a core set assessment.
Actions to Minimize Losses	If a questionnaire is not completed, the project team contacts the families twice per email and once per telephone. In case of no response, these attempts are repeated at their next outpatient clinic visit.
Cleaning Operations	We check for, and remove, doubled patients or doubled responses.
Response Rate	In March 2021, the response rate for the baseline questionnaires was 69% and the follow-up questionnaire ranged from 61%-83% (for the total sample, not specific to disease groups). Currently, we have 5 years’ worth of data.

Life Sciences Metadata

Design Type	Cross Sectional; Cohort Study
Factor Type	Age; Disease State; Sex; Treatment Type
Organism	Homo sapiens

Data Vault Metadata

DV PID	doi:10.34894/FXUGHW
DV PID Version	9.0
Bag ID	urn:uuid:f154f0f5-17aa-4daa-adb9-253b3282eab4
NBN	urn:nbn:nl:ui:13-4886515e-9866-4704-aac3-b928307a126a

Dataset Terms

License/Data Use Agreement	Our Community Norms as well as good scientific practices expect that proper credit is given via citation. Please use the data citation shown on the dataset page. Custom Dataset Terms — the following Custom Dataset Terms have been defined for this dataset.
Terms of Use	The data are sensitive since they involve personal information of patients. There are also restrictions on use by commercial parties, and on sharing openly based on (inter)national laws and regulations and written informed consent. Therefore these data (and additional clinical data) are only available upon signing a Data Sharing Agreement (see Terms of Access) and within a specially designed environment provided by the UMC Utrecht.
Confidentiality Declaration	Depending on who the recipient is and where they are located, a Data Use Agreement or Data Transfer Agreement in line with GDPR regulations will have to be signed. Consortium Agreements are also a possibility in the case of collaborations.
Special Permissions	The data request form has to be completed when requesting the data. Furthermore, the pre-publication checklist has to be followed prior to submission of a manuscript. Both of these can be found in the Data Access and Publication Guidelines. Note that PhD candidates or other students cannot request the data independently, but only in consultation with their supervisor(s).
Restrictions	It is important to note that the PROactive team does not consider overlap in research questions when evaluating data requests. The data cannot be used for purposes other than what it was specifically requested for and it cannot be further shared or distributed. The researchers will be responsible for ensuring the safety and security of the data. The restrictions that apply to the dataset will be outlined in the Data Use Agreement or Data Transfer Agreement.
Citation Requirements	We encourage researchers to include “PROactive Cohort Study” either as keyword or as corporate author on publications. We also ask researchers to include an acknowledgment on behalf of PROactive Cohort Study, this text can be found in the Data Access and Publication Guidelines. If possible, we also ask the PROactive Cohort Study logo in combination with the WKZ logo to be used in all communication materials.
Conditions	All projects requesting PROactive Cohort Study data should be appropriately funded and sustainable.

Restricted Files + Terms of Access

Data Access Place	Accessing the data may require utilizing the Digital Research Environment at the University Medical Center Utrecht or SURFfilesender for a secure data transfer.
Availability Status	Documentation and information regarding the dataset can be found on DataverseNL, but the dataset itself is not publicly available for download, as it contains sensitive personal data. The data will only be delivered when a data request is approved and all the necessary agreements are signed.
Study Completion	This is an ongoing study, so there isn’t a complete dataset. Twice a year we carry out a ‘data lock’ where all data collected in the previous 6 months are added to the larger dataset.