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 r...
| Main Authors: | , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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BMJ Publishing Group
2023-06-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/13/6/e071822.full |
| _version_ | 1827175519881265152 |
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| author | Mattijs E Numans Tobias N Bonten Geert-Jan Dinant Joan G Meeder M Elske van den Akker-van Marle Mark J Boogers Robert T A Willemsen Simone van den Bulk Annelieke H J Petrus Braim M Rahel |
| author_facet | Mattijs E Numans Tobias N Bonten Geert-Jan Dinant Joan G Meeder M Elske van den Akker-van Marle Mark J Boogers Robert T A Willemsen Simone van den Bulk Annelieke H J Petrus Braim M Rahel |
| author_sort | Mattijs E Numans |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-03-12T15:33:44Z |
| format | Article |
| id | doaj.art-bf5227bc098a41018eb2e84e20b38270 |
| institution | Directory Open Access Journal |
| issn | 2044-6055 |
| language | English |
| last_indexed | 2025-03-21T04:12:44Z |
| publishDate | 2023-06-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj.art-bf5227bc098a41018eb2e84e20b382702024-07-29T02:10:10ZengBMJ Publishing GroupBMJ Open2044-60552023-06-0113610.1136/bmjopen-2023-071822Ruling 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)Mattijs E Numans0Tobias N Bonten1Geert-Jan Dinant2Joan G Meeder3M Elske van den Akker-van Marle4Mark J Boogers5Robert T A Willemsen6Simone van den Bulk7Annelieke H J Petrus8Braim M Rahel91 Public Health and Primary Care, Leiden University Medical Center, Leiden, Zuid-Holland, Netherlands1 Public Health and Primary Care, Leiden University Medical Center, Leiden, The NetherlandsDepartment of Family Medicine, Maastricht University, Maastricht, The NetherlandsCardiology, VieCuri Medisch Centrum voor Noord-Limburg, Venlo, The NetherlandsBiomedical Data Sciences, Leiden University Medical Center, Leiden, The NetherlandsCardiology, Leiden Universitair Medisch Centrum, Leiden, The NetherlandsDepartment of Family Medicine, Maastricht University, Maastricht, The NetherlandsPublic Health and Primary Care, Leiden Universitair Medisch Centrum, Leiden, The NetherlandsPublic Health and Primary Care, Leiden Universitair Medisch Centrum, Leiden, The NetherlandsCardiology, VieCuri Medisch Centrum voor Noord-Limburg, Venlo, The NetherlandsIntroduction 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.https://bmjopen.bmj.com/content/13/6/e071822.full |
| spellingShingle | Mattijs E Numans Tobias N Bonten Geert-Jan Dinant Joan G Meeder M Elske van den Akker-van Marle Mark J Boogers Robert T A Willemsen Simone van den Bulk Annelieke H J Petrus Braim M Rahel 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) BMJ Open |
| title | 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) |
| title_full | 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) |
| title_fullStr | 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) |
| title_full_unstemmed | 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) |
| title_short | 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) |
| title_sort | 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 |
| url | https://bmjopen.bmj.com/content/13/6/e071822.full |
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