Leidsche Rijn Julius Gezondheidscentra

Research

Utrecht Health Project

The Utrecht Health project (UHP) is an ongoing center prospective cohort study taking place in Leidsche Rijn (www.ncbi.nlm.nih.gov/pubmed/15921047). Leidsche Rijn is a newly developed residential area west of the city of Utrecht, the Netherlands and by 2023 over 80,000 new inhabitants are expected to have found their homes in this area. UHP started in 2000 and over 40,000 individuals registered at one of the 5 Leidsche Rijn Julius Health Centers.

Of these 40,000 patients we collect routine health care data  which is obtained from the GP registry. For this data collection no informed consent is needed. More in-depth information is collected for the patients who participate in UHP. At this moment we enrolled over 10,000 patients.

In short, all new inhabitants are invited by their general practitioner to participate in UHP. Informed consent is obtained (see ethics and privacy rules). At baseline an individual health profile (IHP) is made by dedicated research nurses. 

The IHP is the starting point for the UHP research database as well as for the primary care electronic medical records. Follow-up data are collected through continuous linkage with the computerized medical files recorded by the general practitioners. UHP staff in each practice takes care of quality management of registration as well as data handling.

Whistler

Embedded in the Utrecht Health Project is WHISTLER (www.ncbi.nlm.nih.gov/pubmed/15499901). The Wheezing Illnesses Study Leidsche Rijn (WHISTLER) was initiated in December 2001 as a single-centre prospective birth cohort study.

It is an ongoing study and includes a population-based sample of at least 3,000 healthy newborns. The aims of WHISTLER are to investigate determinants for wheezing illnesses (including neonatal lung function, viral infections, asthma-susceptibility genes and endotoxin exposure) and to derive a comprehensive risk score, that is appropriate for use in primary health care and allows for efficient planning of early preventive strategies.

Healthy infants born in Leidsche Rijn are enrolled at the age of 2 or 3 weeks. Exclusion criteria are gestational age < 36 weeks, major congenital abnormalities, and neonatal respiratory disease. Baseline examination includes a questionnaire evaluating known risk factors for wheezing illnesses; anthropometric measurements; measurements of infant and parental lung function; and sampling of infant and parental DNA.

Participants are followed for events using data from a questionnaires; visits to the general practitioner (primary health care visits, drugs prescriptions and hospital referral); and for respiratory events with viral sampling during wheezing episodes; and house dust sampling. 

In November 2007 the study was extended to address cardiovascular research questions (WHISTLER-Cardio) (www.ncbi.nlm.nih.gov/pubmed/24174402). All children who had reached the age of 5 years are invited. At that visit lung function measurements are performed and a questionnaire is completed by the parents to collect information of both child and parental determinants concerning the previous years. Anthropometric measurements are obtained (body-weight, height, waist and hip circumference).

In addition, intra-abdominal and subcutaneous fat are measured using ultrasound. In all subjects, vascular properties of the right common carotid artery are studied using high-resolution echotracking technology (intima-media thickness, carotid stiffness). During ultrasonography, blood pressure is recorded twice at the brachial artery using a semi-automatic oscillometric device

WHISTLER provides an unique framework to address issues in childhood respiratory and cardiovascular disease that are currently insufficiently understood. 

 

Data collection

During the first examination the Individual Health Profile (IHP) of each participant is taken.

This includes information on medical history, (Chronic disorders, surgery, infectious diseases, allergies, medication, risk factors).

With questionnaires information is obtained on 

  • Social and economic status (education, occupation)
  • Health (diseases, medication)
  • Physical problems
  • Life-style factors (alcohol, smoking, physical activity)
  • Use of health care (GP, specialists, hospitals, physiotherapists, dentists)
  • Accidents


To address certain topics, dedicated questionnaires are given such as

  • Rand SF36 questionnaire (well-being)
  • SCL90 (psychiatric diagnosis list)
  • SDQ (psychosocial condition of children)
  • GHQ12 (general health status)
  • Rose (cardiovascular disease)
  • VvZ Dyspepsia (abdominal complaints)

In addition to questionnaire information is collected on age, gender, height, weight, blood pressure, serum cholesterol, LDL cholesterol, and serum glucose. Blood samples are being stored. Genetic information has been collected on a number of participants.


Follow-up data are continuously collected from routine health care data as described in detail elsewhere  (http://www.ncbi.nlm.nih.gov/pubmed/25548311) The Dutch healthcare system provides for a fixed list of inhabitants to be taken care of by each GP in each healthcare centre with access to secondary care only via the GP, which assures a complete coverage of subsequent medical events.

The computerized medical records in general practice include

  • Diagnostic data (blood pressure, physical examination findings)
  • Additional investigations (e.g. laboratory results, radiology, endoscopy)
  • Summarized patient history
  • Treatment (prescribed drugs as well as surgery and other interventions)

 

Ethics and Privacy rules

The approach to data collection depends heavily on state-of-the art information technology. Without creating an unwanted possibility to trace back data to specific individuals, files can be gathered and links can be made from the GPs medical record to other files, including those from pharmacies, hospitals, cancer registries, mortality registries, hospital data and the Municipal Health Service.

Protection participant’s privacy has been a leading principle of the UHP. The design of the study has been discussed with representatives of the Dutch Patient and Healthcare Consumer Platform and has been approved by the Dutch Health Care Inspectorate. The masking of all personal data for researchers and for other possible users of LRGP has been regulated in a legal document. The study has been approved by the Medical Ethics Committee of the University Medical Centre Utrecht. All participants give written informed consent.

Dedicated research nurses are assigned to each general practice to conduct the IHP and are bound to the professional privacy regulations of the healthcare centres. An unique code is given to each new participant and all data are sent to the central database under that code number. The same procedures are used for follow-up data to assure that data retraceable to participants are not accessible, either intentionally or by accident, by unauthorized individuals.

Participants note in their informed consent whether they want to be informed on risk factors for disease that may be detected in their LRGP file during a later stage of the study. If disclosure of such information is declined, it will not be given. In case a participant decides to withdraw from the study after the IHP, the data will be unlinked from the code number without disrupting the medical file in the GPs office.

With respect to the WHISTLER cohort in children, the same approach has been taken. WHISTLER-Cardio was approved by the paediatric Medical Ethical Committee of the University Medical Center Utrecht. Written informed parental consent is obtained.

LRGP publications considerations

In a scientific publication based on data obtained in the Utrecht Health Project or its embedded projects, there will be at least one co-author from the principal investigators or steering committee of the Utrecht Health Project.  Apart from intellectual input on subject matter, the UHP co-author ensures the correct referral in the manuscript to the UHP,  the correct description of the methodology regarding to the data collection in the UHP.

As of September 2015, individuals that are considered as principal investigators and/or steering committee members are (alphabetically) Bots ML; Dalmeijer GD; van der Ent CK; Grobbee DE; Hoes AW; Vaartjes I; Uiterwaal CS; Verheij TJ; de Wit NJ.  

Referring to UHP in scientific publications should be a uniform as possible in order to increase the awareness of the UHP cohort study and its recognition by the scientific community. Therefore the UHP steering committee proposes to have the following

In the abstract

  • Mentioning in the methods ‘Utrecht Health Project’.

    • For example:

      • A cohort study of patients enlisted with academic general practices in the Netherlands (the Utrecht Health Project [UHP]).
      • a population-based cohort (the Utrecht Health Project)
      • participants from the Utrecht Health Project

  • Mentioning in the methods ‘WHISTLER’. 

    • For example:

      • the prospective WHISTLER birth-cohort
      • the prospective birth cohort (WHISTLER)
      • the WHISTLER cohort

In the method part of a manuscript

  • The Utrecht Health Project (UHP) is an ongoing dynamic population study initiated in a newly developed large residential area in Leidsche Rijn, part of the city of Utrecht.(ref Grobbee 2005) All new inhabitants were invited by their general practitioner to participate in the UHP. Written informed consent was obtained and an individual health profile (IHP) was made by dedicated research nurses. The UHP study was approved by the Medical Ethical Committee of the University Medical Center, Utrecht, The Netherlands.
     
  • The WHeezing Illnesses STudy LEidsche Rijn (WHISTLER) study is a large ongoing prospective population-based birth cohort on determinants of wheezing illnesses, initiated in December 2001, as described in detail elsewhere (ref Katier 2004). Briefly, healthy newborns in Leidsche Rijn, a new residential area near the city of Utrecht, are enrolled. Exclusion criteria are gestational age < 36 weeks, major congenital abnormalities and neonatal respiratory disease. In November 2007 the study was extended for cardiovascular research questions (WHISTLER-Cardio).

In reference list

  • Grobbee DE, Hoes AW, Verheij TJ, Schrijvers AJ, van Ameijden EJ, Numans ME. The Utrecht Health Project: optimization of routine healthcare data for research. Eur J Epidemiol. 2005;20(3):285-7.
     
  • Katier N, Uiterwaal CS, de Jong BM, Kimpen JL, Verheij TJ, Grobbee DE, Brunekreef B, Numans ME, van der Ent CK; Wheezing Illnesses Study Leidsche Rijn Study Group. The Wheezing Illnesses Study Leidsche Rijn (WHISTLER): rationale and design. Eur J Epidemiol. 2004;19(9):895-903.

Funding

“The Utrecht Health Project received grants from the Ministry of Health, Welfare and Sports (VWS), the University of Utrecht, the Province of Utrecht, the Dutch Organisation of Care Research, the University Medical Centre of Utrecht, and the Dutch College of Healthcare Insurance Companies.”



In publications in Dutch

In the abstract

  • Mentioning in the methods ‘Leidsche Rijn Gezondheids Project’.

    • For example:

      • deelnemers uit het Leidsche Rijn Gezondheidsproject

  • Mentioning in the methods ‘WHISTLER’. 

    • For example:

      • het prospectieve WHISTLER geboorte cohort
      • het WHISTLER cohort

In the method part of a manuscript

  • Het Leidsche Rijn Gezondheids Project (LRGP) is een dynamisch cohort in het nieuwe woongebied Leidsche Rijn, dat onderdeel is van de stad Utrecht (ref Grobbee 2005). Alle nieuwe inwoners worden uitgenodigd door hun huisarts om deel te nemen in LRGP. Nadat deelnemers informed consent hebben gegeven wordt een individueel gezondheidsprofiel in kaart gebracht door een gespecialiseerd onderzoeksverpleegkundige. LRGP is goedgekeurd door de Medisch Ethische Commissie van het Universitair Medisch Centrum Utrecht. 
     
  • De WHeezing Illnesses STudy LEidsche Rijn (WHISTLER) studie is een groot prospectief geboorte cohort dat opgestart is in December 2001 en zicht richt op respiratoire klachten bij kinderen. Uitgebreide details van het cohort zijn elders beschreven (ref Katier 2004). In het kort, pasgeborenen in Leidsche Rijn, een nieuw woongebied in Utrecht, worden in de studie opgenomen. Exclusie criteria zijn vroeggeboorte (

In reference list

  • Grobbee DE, Hoes AW, Verheij TJ, Schrijvers AJ, van Ameijden EJ, Numans ME. The Utrecht Health Project: optimization of routine healthcare data for research. Eur J Epidemiol. 2005;20(3):285-7.
     
  • Katier N, Uiterwaal CS, de Jong BM, Kimpen JL, Verheij TJ, Grobbee DE, Brunekreef B, Numans ME, van der Ent CK; Wheezing Illnesses Study Leidsche Rijn Study Group. The Wheezing Illnesses Study Leidsche Rijn (WHISTLER): rationale and design. Eur J Epidemiol. 2004;19(9):895-903.

reclamebureau anno nu ifthen.nl