The Dutch Parelsnoer Institute Cerebrovascular Disease Initiative: a retrospective study of the effects of integrating clinical care and research on costs and quality of care in patients with ischaemic stroke.

Introduction: The Dutch Parelsnoer Institute (PSI) is a collaboration between all university medical centres in which clinical data, imaging and biomaterials are prospectively and uniformly collected for research purposes. The PSI has the ambition to integrate data collected in the context of clinical care with data collected primarily for research purposes. We aimed to evaluate the effects of such integrated registration on costs, efficiency and quality of care.

The FAIR guiding principles for data stewardship: fair enough?

The FAIR guiding principles for research data stewardship (findability, accessibility, interoperability, and reusability) look set to become a cornerstone of research in the life sciences. A critical appraisal of these principles in light of ongoing discussions and developments about data sharing is in order. The FAIR principles point the way forward for facilitating data sharing more systematically-provided that a number of ethical, methodological, and organisational challenges are addressed as well.

A Stepwise Procedure to Define a Data Collection Framework for a Clinical Biobank.

Introduction: Current guidelines for clinical biobanking have a strong focus on obtaining, handling, and storage of biospecimens. However, to allow for research tying biomarker analysis to clinical decision making, there should be more focus on collection of data on donor characteristics. Therefore, our aim was to develop a stepwise procedure to define a framework as a tool to help start the data collection process in clinical biobanking.

Patients to learn from: on the need for systematic integration of research and care in academic health care.

Unlabelled: Patients suffering from rare, extreme or extremely complex sets of symptoms have something to expect from efforts to improve care through research. Biomedical research and care have often been approached as distinct worlds which are and should be only loosely connected. For observational research focusing on data drawn from real-world settings, however, that approach is found wanting.

Self management for patients with chronic obstructive pulmonary disease.

Background: Self management interventions help patients with chronic obstructive pulmonary disease (COPD) acquire and practise the skills they need to carry out disease-specific medical regimens, guide changes in health behaviour and provide emotional support to enable patients to control their disease. Since the first update of this review in 2007, several studies have been published. The results of the second update are reported here.

[Biobanks and the return of results to donors].

Biobanks should return clinically significant and actionable research findings to donors who have given physical material to the biobank. Because the clinical significance of a research finding is hard to determine for the individual donor, a procedure to decide on clinical significance should be incorporated into a structure for the actual feedback of research results. Most published studies show that donors expect return of individual research results, but there is almost no experience with it.

Rationale and design of the PRegnancy and Infant DEvelopment (PRIDE) Study.

Background: To optimise the health of pregnant women and their children by evidence-based primary and secondary prevention, more scientific knowledge is needed. To overcome the methodological limitations of many studies on pregnancy and child health, which often use a retrospective design, we established the PRIDE (PRegnancy and Infant DEvelopment) Study.

Methods And Results: The PRIDE Study is a large prospective cohort study that aims at including 150 000-200 000 women in early pregnancy to study a broad range of research questions pertaining to pregnancy complications, maternal and child health, and adverse developmental effects in offspring.

Cancer in adolescents and young adults (15-29 years): a population-based study in the Netherlands 1989-2009.

Background: Cancer among adolescents and young adults (AYAs; 15-29 years old) is relatively rare but its incidence is increasing worldwide. To define the extent and nature of the AYA patients, this population-based study was performed to explore trends in cancer incidence, survival and risk of second primary cancers in AYAs.

Material And Methods: Data from all AYAs diagnosed with cancer between 1989 and 2009 were obtained from the Netherlands Cancer Registry.

Excellent adherence and no contamination by physiotherapists involved in a randomized controlled trial on reactivation of COPD patients: a qualitative process evaluation study.

Objective: To assess the adherence of physiotherapists to the study protocol and the occurrence of contamination bias during the course of a randomized controlled trial with a recruitment period of 2 years and a 1-year follow-up (COPE-II study).

Study Design And Setting: In the COPE-II study, intervention patients received a standardized physiotherapeutic reactivation intervention (COPE-active) and control patients received usual care. The latter could include regular physiotherapy treatment.

Weight of in vitro fertilization and intracytoplasmic sperm injection singletons in early childhood.

Birth weight and longitudinal growth in the first 4 years of life of term singletons conceived with the use of IVF and intracytoplasmic sperm injection (ICSI) were compared with those of naturally conceived singletons. Although IVF and ICSI singletons had a statistically significantly lower birth weight than naturally conceived singletons, the average individual weight curves showed that this difference was lost before the age of 4 years in all subgroups: IVF, ICSI, boys, and girls.

Risk factors for undescended testis.

Objective: To contribute to the understanding of the etiology of undescended testis (UDT), by exploring a wide range of potential risk factors in a case-referent study.

Patients And Methods: Cases and referents were recruited at five hospitals and included 200 boys with surgically corrected UDT and 629 boys with persistent middle ear effusion. Risk factor data were obtained by postal questionnaires to both parents.

Decreasing incidence of adenotonsillar problems in Dutch general practice: real or artefact?

Background: The incidence of hypertrophy and recurrent infections of the tonsils/adenoids appears to be decreasing in the Netherlands. It is uncertain whether this is a 'real' decrease in the incidence of disease or an 'artefact'.

Aim: To investigate possible causes of the decreasing incidence of adenotonsillar problems among Dutch children.

Teratogenic mechanisms of medical drugs.

BACKGROUND Although prescription drug use is common during pregnancy, the human teratogenic risks are undetermined for more than 90% of drug treatments approved in the USA during the past decades. A particular birth defect may have its origins through multiple mechanisms and possible exposures, including medications. A specific pathogenic process may result in different outcomes depending upon factors such as embryonic age at which a drug is administered, duration and dose of exposure and genetic susceptibility.

Hypospadias: risk factor patterns and different phenotypes.

Objective: To obtain more insight into the origin of hypospadias by exploring a wide range of potential risk factors in a case-referent study in which a distinction was made between different phenotypes.

Patients And Methods: Cases and referents were 305 boys with hypospadias and 629 boys with middle ear effusion whose parents completed postal questionnaires. Hypospadias phenotype was classified as distal (195 boys), middle (67), and proximal (43).

Definitions of exacerbations: does it really matter in clinical trials on COPD?

Many definitions of COPD exacerbations are reported. The choice for a definition determines the number of exacerbations observed. However, the effect of different definitions on the effect sizes of randomized controlled trials is unclear.

Fatigue and chronic fatigue syndrome-like complaints in the general population.

Background: Most knowledge on chronic fatigue (CF) and chronic fatigue syndrome (CFS) is based on clinical studies, not representative of the general population. This study aimed to assess the prevalence of fatigue in an adult general population and to identify associations with lifestyle factors.

Methods: Total 22,500 residents of Nijmegen were selected at random and interviewed by questionnaire.

Sonotubometry in children with otitis media with effusion before and after insertion of ventilation tubes.

Objectives: To test the outcome of sonotubometric measurement in children with otitis media with effusion (OME) before and after insertion of ventilation tubes.

Design: Eustachian tube ventilatory function was tested in children with OME. To test validity, sonotubometric testing took place before insertion of ventilation tubes (ie, glue ear) and 1 week and 3 months after grommet insertion (ie, aerated middle ear cavity).

Striking trends in the incidence of health problems in The Netherlands (2002-05). Findings from a new strategy for surveillance in general practice.

Background: This study aimed to detect striking trends based on a new strategy for monitoring public health.

Methods: We used data over 4 years from electronic medical records of a large, nationally representative network of general practices. Episodes were either directly recorded by general practitioners (GPs) or were constructed using a new record linkage method (EPICON).

External validation of EPICON: a grouping system for estimating morbidity rates using electronic medical records.

Objective: To externally validate EPICON, a computerized system for grouping diagnoses from EMRs in general practice into episodes of care. These episodes can be used for estimating morbidity rates.

Design: Comparative observational study.

Publication bias was not a good reason to discourage trials with low power.

Objective: The objective was to investigate whether it is justified to discourage trials with less than 80% power. Trials with low power are unlikely to produce conclusive results, but their findings can be used by pooling then in a meta-analysis. However, such an analysis may be biased, because trials with low power are likely to have a nonsignificant result and are less likely to be published than trials with a statistically significant outcome.

Results of sonotubometry in testing eustachian tube ventilatory function in children with cleft palate.

Objectives: In previous studies, an updated sonotubometry setup was tested in healthy adults and children to test its validity and reproducibility in the assessment of the ventilatory function of the eustachian tube (ET). The results were promising, but further investigations were needed to confirm the discriminative potential of this sonotubometry setup. Our objective in the present study was to test the discriminative potential of an updated sonotubometry setup in children with cleft palate.

Objective and perspective determine the choice of composite endpoint.

The most important consideration in the choice of study design and endpoint is that these two features match and represent the objective and the perspective of the trial as closely as possible. The mechanism may also be helpful, but arguments based on the mechanism, structure or levels of the variables, or based on practical considerations, such as (statistical) efficiency, must always be secondary considerations.

Reproductive disorders among male and female greenhouse workers.

The aim of this study was to evaluate reproductive disorders in male and female greenhouse workers. In 2002, data were collected from 4872 Dutch greenhouse workers and 8133 referents through postal questionnaires with detailed questions on reproductive disorders of the most recent pregnancy, lifestyle habits, and occupational exposures (e.g.

Sonotubometry: a useful tool to measure intra-individual changes in eustachian tube ventilatory function.

Objective: To determine whether intra-individual changes in eustachian tube (ET) function induced by local application of a histamine phosphate solution can be detected using an improved sonotubometer.

Design: The function of the ET was measured with a revised sonotubometer before and after histamine was applied to the nasopharyngeal ostium of the ET.

Setting: Tertiary referral hospital.