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Potential flaws in the assessment of minor cerebrovascular events after heart valve replacement
1ICR Cardiovascular Research, London.
Insights
Questionnaires assessing thrombosis, embolism, and bleeding after heart valve replacement are unreliable. Many transient events and even permanent disabilities are forgotten in follow-up questionnaires.
Area of Science:
- Cardiology
- Medical Informatics
Background:
- Assessing adverse events like thrombosis, embolism, and bleeding after heart valve replacement is crucial for patient management.
- Current clinical methods for collecting this data, particularly questionnaires, require critical evaluation for accuracy and completeness.
Purpose of the Study:
- To evaluate the specificity and sensitivity of questionnaire methods in collecting data on thrombosis, embolism, and bleeding post-heart valve replacement.
- To compare the effectiveness of different follow-up methods, including outpatient clinics and mail questionnaires, in capturing patient-reported events.
Main Methods:
- A standard 16-questionnaire from Albert Einstein College of Medicine was administered to 1000 healthy individuals to assess transient events and risk factors.
- Four follow-up methods (outpatient clinic, 6, 18, and 36-month questionnaires) were applied to 123 post-heart valve replacement patients.
- Data on reported events, including transient ischemic attacks (TIAs), and risk factors were collected and analyzed.
Main Results:
- Individuals with risk factors reported a higher incidence of transient ischemic attacks (TIAs) compared to those without.
- A significant number of transient and reversible events (57%) reported at outpatient clinics were forgotten in the 36-month follow-up questionnaire.
- One of three permanent disabilities was also omitted from the questionnaire responses.
Conclusions:
- Questionnaire methods, whether in-person or by mail, demonstrate limited sensitivity in accurately capturing the full spectrum of adverse events after heart valve replacement.
- There is a substantial recall bias, with patients forgetting transient events and even permanent disabilities over time, impacting data reliability.
- Alternative or supplementary methods may be necessary to ensure comprehensive and accurate data collection on post-heart valve replacement complications.
Abstract:
The specificity and sensitivity of the questionnaire method, whether through direct contact or via mail, in collecting information on thrombosis, embolism and bleeding after heart valve replacement were assessed by a critical analysis of methods currently in clinical use. The 16 questions contained in the standard questionnaire of the Albert Einstein College of Medicine searching for transient events were put to 1000 apparently healthy individuals. Additional questions related to risk factors such as previous heart valve replacement, any existing heart disease, hypertension, diabetes or current anticoagulant treatment for any reason were also asked. The male/female ratio was 54.9/45.1, and the mean age was 36.3 years with a range of 14-97 years. Eighty-five persons had one or more risk factors, 915 had none. A positive answer to at least one of the questions searching for TIA (transient ischemic attack) was given by 69.4% (n = 59) of those with, and by 54.8% (n = 501) without any risk factors. The total number of reported 'events' was 164 (1.93/person) for those with, and 1331 (1.45/person) for those without any risk factors. Four different follow up methods were applied to each of 123 patients after heart valve replacement: (a) regular follow up at an out-patient clinic, questionnaires sent at (b) six, (c) 18 and (d) 36 months after the start of the study. 57% of the transient and reversible events reported at the out-patient clinic were forgotten and not mentioned by the same patients in the 36 month questionnaire. One of the three permanent disabilities was also 'forgotten'.(ABSTRACT TRUNCATED AT 250 WORDS)