scholarly journals Recommendations for clinical research in children presenting to primary care out-of-hours services

BJGP Open ◽  
2020 ◽  
pp. bjgpopen20X101154
Author(s):  
Anouk Weghorst ◽  
Gea Holtman ◽  
Pien Ingrid Wolters ◽  
Heleen Russchen ◽  
Freek Fickweiler ◽  
...  
Keyword(s):  
Primary Care ◽  
Cohort Study ◽  
Informed Consent ◽  
General Practitioners ◽  
Selection Bias ◽  
Acute Gastroenteritis ◽  
Out Of Hours ◽  
Informed Consent Procedure ◽  
Consent Procedure ◽  
The Cost

Background: Research in primary care is essential, but recruiting children in this setting can be complex and may cause selection bias. Challenges surrounding informed consent, particularly in an acute clinical setting, can undermine feasibility. The off-protocol use of an intervention nearing implementation has become common in pragmatic randomized controlled trials (RCTs) set in primary care. Aim: To describe how the informed consent procedure affects study inclusion and to assess how off-protocol medication prescribing affects participant selection in a paediatric RCT. Design: A pragmatic RCT evaluating the cost-effectiveness of oral ondansetron in children diagnosed with acute gastroenteritis in primary care out-of-hours services and a parallel cohort study. Method: Consecutive children aged 6 months to 6 years attending primary care out-of-hours services with acute gastroenteritis were evaluated to assess the feasibility of obtaining informed consent, the off-protocol use of ondansetron, and other inclusion/exclusion criteria. Results: The RCTs feasibility was reduced by the informed consent procedure because 39.0% (325/834) of children were accompanied by only one parent. General practitioners prescribed ondansetron off-protocol to 34 children (4.1%), whereof 19 children were eligible for the RCT. RCT-eligible children included in the parallel cohort had fewer risk factors for dehydration than children in the RCT despite similar dehydration assessments by general practitioners. Conclusion: The informed consent procedure and off-protocol use of study medication affect the inclusion rate but had little effect on selection. A parallel cohort study alongside the RCT can help evaluate selection bias, and a pilot study can reveal potential barriers to inclusion.

IMPLEMENTASIROTTERDAM CONVENTION ON THE PRIOR INFORMED CONSENT PROCEDURE FOR CERTAIN HAZARDOUS CHEMICALS AND PESTICIDES IN INTERNATIONAL TRADEBAGI PERKEMBANGAN HUKUM LINGKUNGAN DI INDONESIA

2019 ◽  
Vol 5 (1) ◽  
pp. 90
Author(s):  
Elly Kristiani Purwendah ◽  
Elisabet Pudyastiwi
Keyword(s):  
Informed Consent ◽  
Hazardous Chemicals ◽  
Informed Consent Procedure ◽  
Prior Informed Consent ◽  
Consent Procedure

Konvensi ini memang tidak langsung memberikan efek yang signifikan namun dengan meratifikasi konvensi ini akan memberikan pengaruh terhadap kelangsungan ekspor bahan mentah terlebih sumber daya alam seperti bahan obat-obatan, bahan pangan dan bahan lainnya yang terkontaminasi oleh bahan kimia dan pestisida berbahaya. Ratifikasi konvensi ini akan mempersempit kemungkinan menurunnya kualitas keanekaragaman hayati yang sering dimanfaatkan untuk kebutuhan hidup. Selain itu adanya konvensi ini akan mencegah munculnya masalah terhadap lapangan pekerjaan bagi pihak-pihak yang terkontaminasi limbah maupun bahan kimia dan pestisida yang berbahaya seperti para petani, nelayan dan masyarakat pada umumnya. Jika ditelaah secara mendalam jumlah ekpor pada sektor pertanian setiap tahun terus mengalami penurunan, hal ini disebabkan oleh menurunya kualitas ekosistem persawahan akibat pemakaian pestisida yang berlebihan. Kata kunci : Konvensi Rotterdam, ratifikasi, hukum lingkungan. 

scholarly journals Rationale and design of a cohort study evaluating triage of acute chest pain in out-of-hours primary care in the Netherlands (TRACE)

2020 ◽  
Vol 21 ◽  
Author(s):  
Amy Manten ◽  
Cuny J.J. Cuijpers ◽  
Remco Rietveld ◽  
Emma Groot ◽  
Freek van de Graaf ◽  
...  
Keyword(s):  
Primary Care ◽  
Cohort Study ◽  
Chest Pain ◽  
The Netherlands ◽  
Clinical Outcomes ◽  
Acute Chest Pain ◽  
Urgent Care ◽  
Triage System ◽  
Out Of Hours ◽  
Coronary Syndrome

Abstract The aims of this study are (1) to evaluate the performance of current triage for chest pain; (2) to describe the case mix of patients undergoing triage for chest pain; and (3) to identify opportunities to improve performance of current Dutch triage system for chest pain. Chest pain is a common symptom, and identifying patients with chest pain that require urgent care can be quite challenging. Making the correct assessment is even harder during telephone triage. Temporal trends show that the referral threshold has lowered over time, resulting in overcrowding of first responders and emergency services. While various stakeholders advocate for a more efficient triage system, careful evaluation of the performance of the current triage in primary care is lacking. TRiage of Acute Chest pain Evaluation in primary care (TRACE) is a large cohort study designed to describe the current Dutch triage system for chest pain and subsequently evaluate triage performance in regard to clinical outcomes. The study consists of consecutive patients who contacted the out-of-hours primary care facility with chest pain in the region of Alkmaar, the Netherlands, in 2017, with follow-up for clinical outcomes out to August 2019. The primary outcome of interest is ‘major event’, which is defined as the occurrence of death from any cause, acute coronary syndrome, urgent coronary revascularization, or other high-risk diagnoses in which delay is inadmissible and hospitalization is necessary. We will evaluate the performance of the triage system by assessing the ability of the triage system to correctly classify patients regarding urgency (accuracy), the proportion of safe actions following triage (safety) as well as rightfully deployed ambulances (efficacy). TRACE is designed to describe the current Dutch triage system for chest pain in primary care and to subsequently evaluate triage performance in regard to clinical outcomes.

scholarly journals Daytime use of general practice and use of the Out-of-Hours Primary Care Service for patients with chronic disease: a cohort study

2014 ◽  
Vol 15 (1) ◽  
Author(s):  
Lone Flarup ◽  
Grete Moth ◽  
Morten Bondo Christensen ◽  
Mogens Vestergaard ◽  
Frede Olesen ◽  
...  
Keyword(s):  
Primary Care ◽  
General Practice ◽  
Cohort Study ◽  
Chronic Disease ◽  
Care Service ◽  
Primary Care Service ◽  
Out Of Hours

The Need for a Standardized Informed Consent Procedure in Live Donor Nephrectomy

2014 ◽  
Vol 98 (11) ◽  
pp. 1134-1143 ◽  
Author(s):  
Kirsten Kortram ◽  
Jeffrey A. Lafranca ◽  
Jan N.M. IJzermans ◽  
Frank J.M.F. Dor
Keyword(s):  
Informed Consent ◽  
Donor Nephrectomy ◽  
Live Donor ◽  
Informed Consent Procedure ◽  
Live Donor Nephrectomy ◽  
Consent Procedure
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