Early diagnosis of coeliac disease in the Preventive Youth Health Care Centres in the Netherlands: study protocol of a case finding study (GLUTENSCREEN)

IntroductionCoeliac disease (CD) occurs in 1% of the population, develops early in life and is severely underdiagnosed. Undiagnosed and untreated disease is associated with short-term and long-term complications. The current healthcare approach is unable to solve the underdiagnosis of CD and timely diagnosis and treatment is only achieved by active case finding. Aim: to perform a case finding project to detect CD children who visit the Youth Health Care Centres (YHCCs) in a well-described region in the Netherlands to evaluate whether it is feasible, cost-effective and well accepted by the population.Methods/analysisProspective intervention cohort study. Parents of all children aged 12 months and 4 years attending the YHCCs for a regular visit are asked whether their child has one or more CD-related symptoms from a standardised list. If so, they will be invited to participate in the case finding study. After informed consent, a point of care test (POCT) to assess CD-specific antibodies against tissue transglutaminase (TG2A) is performed onsite the YHCCs. If the POCT is positive, CD is highly suspected and the child will be referred to hospital for definitive diagnosis according to the Guideline Coeliac Disease of the European Society for Pediatric Gastroenterology, Hepatology and Nutrition guideline.Main outcomesIncidence rate of new CD diagnoses in the study region in comparison to the one in the same age diagnosed by standard of care in the rest of the Netherlands.Feasibility and cost-effectiveness of active CD case finding at the YHCCs. All costs of active case finding, diagnostics and treatment of CD and the potential short-term and long-term consequences of the disease will be calculated for the setting with and without case finding.Ethical acceptability: by questionnaires on parental and healthcare professionals’ satisfaction.A statistical analysis plan was prepared and is published on the GLUTENSCREEN website (Statistical-Analysis-Plan-11-5-2021_def.pdf (glutenscreen.nl) and added as annex 1).Ethics and disseminationThe Medical Ethics Committee Leiden approved this study. If we prove that case finding at the YHCC is feasible, cost-effective and well accepted by the population, implementation is recommended.Trial registration numberNL63291.058.17.

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Early diagnosis of coeliac disease in the Preventive Youth Health Care Centres in the Netherlands: study protocol of a case-finding study (GLUTENSCREEN).

10.1101/2021.04.24.21254842 ◽

2021 ◽

Author(s):

Caroline Meijer-Boekel ◽

M. Elske van den Akker ◽

Leti van Bodegom ◽

Johanna C. Escher ◽

Nan van Geloven ◽

...

Keyword(s):

Health Care ◽

The Netherlands ◽

Cost Effective ◽

Case Finding ◽

Active Case Finding ◽

Youth Health ◽

Active Case ◽

Finding Study ◽

Short And Long Term

Introduction: Coeliac disease (CD) occurs in 1% of the population, develops early in life and is severely underdiagnosed. Undiagnosed and untreated disease is associated with short- and long-term complications. Treatment with a gluten-free diet results in health improvement. The current health care approach is unable to solve the underdiagnosis of CD and timely diagnosis and treatment is only achieved by active case finding. Aim of this study is to perform a novel case-finding project to detect CD in 12 months-4 years old symptomatic children who visit the YHCCs in a well-described region in the Netherlands to show that it is feasible, cost-effective and well accepted by the population. Methods/analysis: Prospective intervention cohort study. Parents of all children aged 12 months-4 years attending the Youth Health Care Centres (YHCCs) for a regular visit are asked if their child has one or more CD-related symptoms from a standardized list. If so, they will be invited to participate in the case-finding study. After informed consent, a point of care test (POC) to assess CD-specific antibodies against tissue-transglutaminase (TG2A) from a droplet of blood, is performed onsite at the YHCCs. If the POC test is positive, CD is highly suspected and the child will be referred to hospital for definitive diagnosis according to the ESPGHAN guideline. Main outcomes: 1. incidence rate of new CD diagnoses in the study region Kennemerland in comparison to the rest of the Netherlands. 2. Feasibility and cost-effectiveness of active case-finding for CD in the YHCCs. All costs of active case finding, diagnostics and treatment of CD and the potential short and long term consequences of the disease will be calculated for the setting with and without case finding. 3. Ethical acceptability: by questionnaires on parental and health care professionals satisfaction. A statistical analysis plan (SAP) has been written and will be published on the GLUTENSCREEN website. Ethics and dissemination: The Medical Ethics Committee Leiden approved this study. If we prove that active case finding in the YHCC is feasible, efficient, cost-effective and well accepted by the population, implementation is recommended. Trial registration number: NL63291.058.17

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Detailed statistical analysis plan for the short-term versus long-term mentalisation-based therapy for outpatients with subthreshold or diagnosed borderline personality disorder randomised clinical trial (MBT-RCT)

Trials ◽

10.1186/s13063-021-05450-y ◽

2021 ◽

Vol 22 (1) ◽

Author(s):

Sophie Juul ◽

Sebastian Simonsen ◽

Stig Poulsen ◽

Susanne Lunn ◽

Per Sørensen ◽

...

Keyword(s):

Statistical Analysis ◽

Borderline Personality Disorder ◽

Personality Disorder ◽

Statistical Analysis Plan ◽

Borderline Personality ◽

Individual Therapy ◽

Statistical Analyses ◽

Short Term ◽

Detailed Statistical Analysis

Abstract Background Psychotherapy for borderline personality disorder is often extensive and resource-intensive. Mentalisation-based therapy is a psychodynamically oriented treatment option for borderline personality disorder, which includes a case formulation, psychoeducation, and group and individual therapy. The evidence on short-term compared with long-term mentalisation-based therapy is currently unknown. Methods/design The Short-Term MBT Project (MBT-RCT) is a single-centre, parallel-group, investigator-initiated, randomised clinical superiority trial in which short-term (20 weeks) will be compared with long-term (14 months) mentalisation-based therapy for outpatients with subthreshold or diagnosed borderline personality disorder. Outcome assessors, data managers, the data safety and monitoring committee, statisticians, and decision-makers will be blinded to treatment allocation. Participants will be assessed before randomisation and at 8, 16, and 24 months after randomisation. The primary outcome will be the severity of borderline symptomatology assessed with the Zanarini Rating Scale for Borderline Personality Disorder. Secondary outcomes will be functional impairment (Work and Social Adjustment Scale), quality of life (Short-Form Health Survey 36—mental component), global functioning (Global Assessment of Functioning), and proportion of participants with severe self-harm. In this paper, we present a detailed statistical analysis plan including a comprehensive explanation of the planned statistical analyses, methods to handle missing data, and assessments of the underlying statistical assumptions. Final statistical analyses will be conducted independently by two statisticians following the present plan. Discussion We have developed this statistical analysis plan before unblinding of the trial results in line with the Declaration of Helsinki and the International Conference on Harmonization of Good Clinical Practice Guidelines, which should increase the validity of the MBT-RCT trial by mitigation of analysis bias. Trial registration ClinicalTrials.gov NCT03677037. Registered on 19 September 2018

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Cost-effectiveness of a hybrid emergency room system for severe trauma: a health technology assessment from the perspective of the third-party payer in Japan

World Journal of Emergency Surgery ◽

10.1186/s13017-020-00344-x ◽

2021 ◽

Vol 16 (1) ◽

Author(s):

Takahiro Kinoshita ◽

Kensuke Moriwaki ◽

Nao Hanaki ◽

Tetsuhisa Kitamura ◽

Kazuma Yamakawa ◽

...

Keyword(s):

Cost Effectiveness ◽

Emergency Room ◽

Healthcare Costs ◽

Cost Effective ◽

Severe Trauma ◽

Third Party ◽

Trauma Patients ◽

Short Term ◽

The Third

Abstract Background Hybrid emergency room (ER) systems, consisting of an angiography-computed tomography (CT) machine in a trauma resuscitation room, are reported to be effective for reducing death from exsanguination in trauma patients. We aimed to investigate the cost-effectiveness of a hybrid ER system in severe trauma patients without severe traumatic brain injury (TBI). Methods We conducted a cost-utility analysis comparing the hybrid ER system to the conventional ER system from the perspective of the third-party healthcare payer in Japan. A short-term decision tree and a long-term Markov model using a lifetime time horizon were constructed to estimate quality-adjusted life years (QALYs) and associated lifetime healthcare costs. Short-term mortality and healthcare costs were derived from medical records and claims data in a tertiary care hospital with a hybrid ER. Long-term mortality and utilities were extrapolated from the literature. The willingness-to-pay threshold was set at $47,619 per QALY gained and the discount rate was 2%. Deterministic and probabilistic sensitivity analyses were conducted. Results The hybrid ER system was associated with a gain of 1.03 QALYs and an increment of $33,591 lifetime costs compared to the conventional ER system, resulting in an ICER of $32,522 per QALY gained. The ICER was lower than the willingness-to-pay threshold if the odds ratio of 28-day mortality was < 0.66. Probabilistic sensitivity analysis indicated that the hybrid ER system was cost-effective with a 79.3% probability. Conclusion The present study suggested that the hybrid ER system is a likely cost-effective strategy for treating severe trauma patients without severe TBI.

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KAMEDO Report No. 82 Explosion at the Fireworks Warehouse in the Netherlands in 2000

Prehospital and Disaster Medicine ◽

10.1017/s1049023x00003502 ◽

2006 ◽

Vol 21 (2) ◽

pp. 123-125 ◽

Cited By ~ 1

Author(s):

Viveka Björnhagen ◽

Torbjörn Messner ◽

Helge Brändström

Keyword(s):

The Netherlands ◽

Communication Networks ◽

Psychosocial Support ◽

Public Information ◽

Short Term ◽

Disaster Plan ◽

Counselling Center

AbstractA fire and subsequent explosions occurred in a fireworks warehouse on 13 May 2000. A total of 947 persons were injured and 21 persons died, including four firefighters and one reporter. Communication networks became overloaded and impaired notification chains. The hospital disaster plan was followed, but was proved inadequate. Public information was a high priority. A counselling center was established early and was planned to continue operation for five years. The command function did not perform to expectations. Hospital triage was impaired as many responsible left the triage area. Short-term psychosocial support evolved to long-term programs. Liability issues were examined.

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Coeliac disease in primary care: case finding study

BMJ ◽

10.1136/bmj.318.7194.1341-b ◽

1999 ◽

Vol 318 (7194) ◽

pp. 1341.2

Keyword(s):

Primary Care ◽

Coeliac Disease ◽

Case Finding ◽

Finding Study

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Multi-centre, randomised non-inferiority trial of early treatment versus expectant management of patent ductus arteriosus in preterm infants (the BeNeDuctus trial): statistical analysis plan

Trials ◽

10.1186/s13063-021-05594-x ◽

2021 ◽

Vol 22 (1) ◽

Author(s):

Tim Hundscheid ◽

Rogier Donders ◽

Wes Onland ◽

Elisabeth M. W. Kooi ◽

Daniel C. Vijlbrief ◽

...

Keyword(s):

Statistical Analysis ◽

Patent Ductus Arteriosus ◽

Preterm Infants ◽

Pharmacological Treatment ◽

Ductus Arteriosus ◽

Expectant Management ◽

The United States ◽

Statistical Analysis Plan ◽

Short Term ◽

Patent Ductus

Abstract Background Controversy exists about the optimal management of a patent ductus arteriosus (PDA) in preterm infants. A persistent PDA is associated with neonatal mortality and morbidity, but causality remains unproven. Although both pharmacological and/or surgical treatment are effective in PDA closure, this has not resulted in an improved neonatal outcome. In most preterm infants, a PDA will eventually close spontaneously, hence PDA treatment potentially increases the risk of iatrogenic adverse effects. Therefore, expectant management is gaining interest, even in the absence of convincing evidence to support this strategy. Methods/design The BeNeDuctus trial is a multicentre, randomised, non-inferiority trial assessing early pharmacological treatment (24–72 h postnatal age) with ibuprofen versus expectant management of PDA in preterm infants in Europe. Preterm infants with a gestational age of less than 28 weeks and an echocardiographic-confirmed PDA with a transductal diameter of > 1.5 mm are randomly allocated to early pharmacological treatment with ibuprofen or expectant management after parental informed consent. The primary outcome measure is the composite outcome of mortality, and/or necrotizing enterocolitis Bell stage ≥ IIa, and/or bronchopulmonary dysplasia, all established at a postmenstrual age of 36 weeks. Secondary short-term outcomes are comorbidity and adverse events assessed during hospitalization and long-term neurodevelopmental outcome assessed at a corrected age of 2 years. This statistical analysis plan focusses on the short-term outcome and is written and submitted without knowledge of the data. Trial registration ClinicalTrials.gov NTR5479. Registered on October 19, 2015, with the Dutch Trial Registry, sponsored by the United States National Library of Medicine Clinicaltrials.gov NCT02884219 (registered May 2016) and the European Clinical Trials Database EudraCT 2017-001376-28.

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Coeliac disease in primary care: case finding study

BMJ ◽

10.1136/bmj.318.7177.164 ◽

1999 ◽

Vol 318 (7177) ◽

pp. 164-167 ◽

Cited By ~ 202

Author(s):

H. Hin ◽

G. Bird ◽

P. Fisher ◽

N. Mahy ◽

D. Jewell

Keyword(s):

Primary Care ◽

Coeliac Disease ◽

Case Finding ◽

Finding Study

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Cost-effectiveness of targeted screening for hepatitis C in The Netherlands

Epidemiology and Infection ◽

10.1017/s0950268811000112 ◽

2011 ◽

Vol 140 (1) ◽

pp. 58-69 ◽

Cited By ~ 15

Author(s):

C. W. HELSPER ◽

B. A. BORKENT-RAVEN ◽

N. J. DE WIT ◽

G. A. VAN ESSEN ◽

M. J. M. BONTEN ◽

...

Keyword(s):

Primary Care ◽

Cost Effectiveness ◽

Hepatitis C ◽

The Netherlands ◽

Drug Users ◽

Cost Effective ◽

Case Finding ◽

Hard Drug ◽

Effective Interventions ◽

Additional Support

SUMMARYOn account of the serious complications of hepatitis C virus (HCV) infection and the improved treatment possibilities, the need to improve HCV awareness and case-finding is increasingly recognized. To optimize a future national campaign with this objective, three pilot campaigns were executed in three regions in The Netherlands. One campaign was aimed at the general population, a second (similar) campaign was extended with a support programme for primary care and a third campaign was specifically aimed at hard-drug users. Data from the pilot campaigns were used to build a mathematical model to estimate the incremental cost-effectiveness ratio of the different campaigns. The campaign aimed at the general public without support for primary care did not improve case-finding and was therefore not cost-effective. The similar campaign accompanied by additional support for primary care and the campaign aimed at hard-drug users emerged as cost-effective interventions for identification of HCV carriers.

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