Ruling out acute coronary syndrome in primary care with a clinical decision rule and a capillary, high-sensitive troponin I point of care test: study protocol of a diagnostic RCT in the Netherlands (POB HELP)

Introduction
Chest pain is a common reason for consultation in primary care. To rule out acute coronary syndrome (ACS), general practitioners (GP) refer 40%–70% of patients with chest pain to the emergency department (ED). Only 10%–20% of those referred, are diagnosed with ACS. A clinical decision rule, including a high-sensitive cardiac troponin-I point-of-care test (hs-cTnI-POCT), may safely rule out ACS in primary care. Being able to safely rule out ACS at the GP level reduces referrals and thereby alleviates the burden on the ED. Moreover, prompt feedback to the patients may reduce anxiety and stress.

Methods and analysis
The POB HELP study is a clustered randomised controlled diagnostic trial investigating the (cost-)effectiveness and diagnostic accuracy of a primary care decision rule for acute chest pain, consisting of the Marburg Heart Score combined with a hs-cTnI-POCT (limit of detection 1.6 ng/L, 99th percentile 23 ng/L, cut-off value between negative and positive used in this study 3.8 ng/L). General practices are 2:1 randomised to the intervention group (clinical decision rule) or control group (regular care). In total 1500 patients with acute chest pain are planned to be included by GPs in three regions in The Netherlands. Primary endpoints are the number of hospital referrals and the diagnostic accuracy of the decision rule 24 hours, 6 weeks and 6 months after inclusion.

Ethics and dissemination
The medical ethics committee Leiden-Den Haag-Delft (the Netherlands) has approved this trial. Written informed consent will be obtained from all participating patients. The results of this trial will be disseminated in one main paper and additional papers on secondary endpoints and subgroup analyses.

Trial registration numbers
NL9525 and NCT05827237.

Leggi
Giugno 2023

Waiting for an RCT of Nirmatrelvir for Prevention of Post–COVID-19 Condition

Post–COVID-19 condition (PCC), the persistence of symptoms beyond 90 days past the acute episode, also known as long COVID, is of great concern because of the large number of persons who become infected with SARS-CoV-2 and the frequency with which PCC occurs, estimated in 1 large study from the United Kingdom as 7.8% to 17%. The oral drug nirmatrelvir was approved for treating acute COVID-19 based on evidence that it decreases progression of disease when started within 5 days of infection. But does it prevent PCC?

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Giugno 2023