Study sought to use sex-specific upper reference limits of high sensitive Troponin I for improved measures to manage heart disease in women
A study titled, ‘Increased Accuracy for the Diagnosis of Acute Myocardial Infarction Using Sex-Specific Upper Reference Limits of High Sensitive Troponin I in Clinical Pathways for Patients Presenting with Suspected Acute Coronary Syndrome’ done by researchers/clinicians at Mumbai’s Kokilaben Dhirubhai Ambani Hospital & Medical Research Institute (KDAH) recently received a Certificate of Achievement from the UNIVANTS of Healthcare Excellence.
The KDAH team was one of the 12 teams earning this honour amongst 180 initiated applications from 141 countries, and is also the first healthcare institution recognised from India by the UNIVANTS of Healthcare Excellence Programme.
This recognition is by IFCC, AACC, EHMA, Modern Healthcare, HIMSS, NAHQ, and Institute of Health Economics and funded by Abbott.
The UNIVANTS of Healthcare Excellence Programme is a global award programme created by Abbott in partnership with healthcare organisations across the globe, with a common vision to inspire and celebrate healthcare excellence. The award programme recognises teams who collaborate across disciplines and transform healthcare delivery, and ultimately patient lives.
About the study
Sex differences are common across multiple aspects of cardiovascular care including diagnosis, treatment, and outcomes. Large multi-centered randomised clinical trials have shown that women are under-recognised for acute myocardial infarction (AMI) and consistently have higher fatality rates compared to men, even following adjustments for age and comorbid conditions. Women tend to have atypical symptoms when presenting to Accident and Emergency (A&E) and as such, tend not be recognised for experiencing AMI without male-patterned chest pain symptoms.
Thus, significant efforts across stakeholders have culminated in a greater awareness with improved measures to recognise and manage AMI and coronary artery disease (CAD) in women. Included in these measures are guideline recommendations for the implementation of sex-specific upper reference limits (URLs) into clinical pathways for patients that present to A&E with suspected acute coronary syndrome.
Recognising that poorer outcomes for women vs. men post-intervention may result from delayed diagnosis of women, and with full appreciation that some men may be more aggressively treated based on use of lower upper reference limits that lack sex discrimination, the team at KDAH’s Biochemistry and Immunology Department sought to investigate the opportunity to move from an overall URL to sex-specific URLs consistent with guideline-based care.
This integrated clinical care team simultaneously sought to improve workflow efficiencies, leading to improvements across the care continuum. Site-wide education was crucial for physicians and patients to ensure earlier recognition of disease risk while maximising treatment pathways for optimised patient care.
Management of patients presenting to the A&E Department with chest pain is continuously evolving. The availability of high-sensitivity troponin assays (hsTn I) in the setting of ACS has allowed for the rapid risk assessment of an ongoing myocardial infarction. However, there were concerns raised about the use of the single, universal cut-off value for both men and women as there is a potential risk of under-diagnosis in women as they have a lower threshold value of troponin.
Another concern was regarding improvement in patient triaging through the A&E Department and reduction in the TAT for troponin. Hence, the implementation of a sex-specific cut-off value for hsTnI was postulated due to the need to improve diagnostic performance in female. Furthermore, the implementation of lean six sigma metrics and DMAIC principle helped in TAT reduction of troponin assay in biochemistry laboratory.
A total of 2797 female patients and 2805 male patients attending A&E with a chest pain were enrolled. All patients were tested using the hs-cTnI assay. Implementation of sex-specific upper reference limits identified an additional 14 per cent of at risk women with potential acute myocardial infarction. This in turn also decreased the number of men being diagnosed by 3 per cent.
Furthermore, 6167 male and female patients were enrolled as Quality improvement indicator to reduce TAT. The laboratory quality improvement indicator using lean six sigma methodology and DMAIC principle leads to reduction of Turn Around Time (TAT) of hsTn I assay from 38.2 minutes to 32.6 minutes. There is 1.6 sigma improvement in quality (from 3.14 sigma to 4.75 sigma) and 15 per cent improvement of TAT compliance (74.7 per cent to 99.3 per cent).