The accuracy of the general practitioner's sense of alarm when confronted with dyspnoea and/or thoracic pain : protocol for a prospective observational study

INTRODUCTION: Dyspnoea and chest pain are signs shared with multiple pathologies ranging from the benign to life-threatening diseases. Gut feelings such as the sense of alarm and the sense of reassurance are known to play a substantial role in the diagnostic reasoning of general practitioners (GPs). A Gut Feelings Questionnaire (GFQ) has been validated to measure the GP's sense of alarm. A French version of the GFQ is available following a linguistic validation procedure. The aim of the study is to calculate the diagnostic test accuracy of a GP's sense of alarm when confronted with dyspnoea and chest pain. METHODS AND ANALYSIS: Prospective observational study. Patients aged between 18 and 80 years, consulting their GP for dyspnoea and/or thoracic pain will be considered for enrolment in the study. These GPs will have to complete the questionnaire immediately after the consultation for dyspnoea and/or thoracic pain. The follow-up and the final diagnosis will be collected 4 weeks later by phone contact with the GP or with the patient if their GP has no information. Life-threatening and non-life-threatening diseases have previously been defined according to the pathologies or symptoms in the (ICPC2) International Collegiate Programming Contest classification. Members of the research team, blinded to the actual outcomes shown on the index questionnaire, will judge each case in turn and will, by consensus, classify the expected outcomes as either life-threatening or non-life-threatening diseases. The sensitivity, the specificity, the positive and negative likelihood ratio of the sense of alarm will be calculated from the constructed contingency table. ETHICS AND DISSEMINATION: This study was approved by the ethical committee of the University de Bretagne Occidentale. A written informed consent form will be signed and dated by GPs and patients at the beginning of the study. The results will be published in due course

Incidents in Molecular Pathology: Frequency and Causes During Routine Testing.

CONTEXT.— Errors in laboratory medicine could compromise patient safety. Good laboratory practice includes identifying and managing nonconformities in the total test process. Varying error percentages have been described in other fields but are lacking for molecular oncology. OBJECTIVES.— To gain insight into incident causes and frequency in the total test process from 8 European institutes routinely performing biomarker tests in non-small cell lung cancer and colorectal cancer. DESIGN.— All incidents documented in 2018 were collected from all hospital services for pre-preanalytical entries before the biomarker test, as well as specific incidents for biomarker tests. RESULTS.— There were 5185 incidents collected, of which 4363 (84.1%) occurred in the pre-preanalytical phase (all hospital services), 2796 of 4363 (64.1%) related to missing or incorrect request form information. From the other 822 specific incidents, 166 (20.2%) were recorded in the preanalytical phase, 275 (33.5%) in the analytical phase, and 194 (23.6%) in the postanalytical phase, mainly due to incorrect report content. Only 47 of 822 (5.7%) incidents were recorded in the post-postanalytical phase, and 123 (15.0%) in the complete total test process. For 17 of 822 (2.1%) incidents the time point was unknown. Pre-preanalytical incidents were resolved sooner than incidents on the complete process (mean 6 versus 60 days). For 1215 of 5168 (23.5%) incidents with known causes a specific action was undertaken besides documenting them, not limited to accredited institutes. CONCLUSIONS.— There was a large variety in the number and extent of documented incidents. Correct and complete information on the request forms and final reports are highly error prone and require additional focus