Construction and Validation of a Diagnostic Scoring System for Predicting Active Pulmonary Tuberculosis in Patients with Positive T-SPOT Based on Indicators Associated with Coagulation and Inflammation: A Retrospective Cross-Sectional Study

Abstract

Introduction

Tuberculosis (TB) is a life-threatening single infectious disease, which remains a major global public health concern. This study was to establish and validate a clinically practical diagnostic scoring system for predicting active pulmonary tuberculosis (APTB) in patients with positive tuberculosis T cell spot test [T-SPOT] using indicators associated with coagulation and inflammation.

Methods

A single-center retrospective cross-sectional study was performed to include patients with positive T-SOPT registered and hospitalized at Wuhan Jinyintan Hospital between January 2017 and December 2019. All patients were separated into the active pulmonary tuberculosis (APTB) group and the inactive pulmonary tuberculosis (IPTB) group, according to the diagnostic criteria from China’s Expert Consensus for APTB and IPTB. Subsequently, the patients were randomized into a training set and a validation set at a ratio of 2:1. Indicators associated with coagulation and inflammation, including prothrombin time activity (PTA), activated partial thromboplastin time (APTT), thrombin time (TT), fibrinogen concentration (Fbg-C), C-reactive protein/albumin ratio (CAR), C-reactive protein/prealbumin ratio (CPR), neutrophils count/lymphocyte count ratio (NLR), platelet count/lymphocyte count ratio (PLR), monocyte count/lymphocyte count ratio (MLR), and erythrocyte sedimentation rate (ESR) were obtained from electronic medical record system (EMRS). Stepwise logistic regression was performed in the training set to build a diagnostic model for predicting APTB, which was transformed into an easily applicable scoring system via nomogram. Receiver operating characteristic (ROC) analysis, calibration curve (CC), and decision curve analysis (DCA) were conducted to evaluate the predictive performance of the established diagnostic scoring system.

Results

A total of 508 patients [training set (211 cases of APTB and 116 cases of IPTB) and validation set (103 cases of APTB and 78 cases of IPTB)] with positive T-SPOT were recruited in the study. Stepwise logistic regression showed that CPR, MLR, ESR, APTT and Fbg-C were independent predictors for APTB. The scoring system was subsequently formulated based on the abovementioned predictors, which correspond to scores of 10, 6, 7, 5, and 5, respectively. In addition, patients are more likely to be diagnosed as APTB when the cut-off score was ≥16 scores, while patients with <16 scores are more likely to be diagnosed as IPTB. The scoring system showed good predictive efficacy in both the training set [area under the curve (AUC): 0.887] and the validation set (AUC: 0.898). Furthermore, both CC and DCA confirmed the clinical utility of the scoring system.

Conclusion

The data suggest that the combination of indicators associated with coagulation and inflammation could serve as biomarkers to identify APTB in patients with positive T-SPOT. In addition, patients with positive T-SPOT were more prone to be diagnosed with APTB when having a combined total of scores ≥16 in the scoring system.

Keywords:

• coagulation indices
• inflammatory biomarkers
• scoring system
• active pulmonary tuberculosis

Abbreviations

APTB, active pulmonary tuberculosis; IPTB, inactive pulmonary tuberculosis; ROC, receiver operating characteristic curve; AUC, area under the curve; CI, confidence interval; CAR, C-reactive protein/prealbumin ratio; CPR, C-reactive protein/prealbumin ratio; NLR, Neutrophils count/lymphocyte count ratio; MLR, monocyte count/lymphocyte count ratio; PLR, Platelet count/lymphocyte count ratio; ESR, erythrocyte sedimentation rate; PT, prothrombin time; PTA, prothrombin time activity; INR, international normalized ratio; APTT, activated partial thromboplastin time; Fbg-C, fibrinogen concentration; OR, Odds Ratio; CI, confidence interval.

Data Sharing Statement

The datasets used in this study are obtainable from the corresponding author on request.

Ethics Statement

The study was conducted according to the good clinical practice guidelines and the Declaration of Helsinki. The Ethics Committee of Wuhan Jinyintan Hospital (KY-2022-06.01) reviewed and approved this study, and approved that informed consent was signed by patients or their guardians. Informed consent was signed by the guardians of the patients only if the patients are deemed incompetent for informed consent due to their physical conditions, such as psychiatric disorders, comatose state and so on.

Acknowledgments

We thank Lin Li, Jisong Yan, and Zhe Chen for the support with data acquisition, interpretation, and analysis, and Lijuan Zheng for the support with conceptualization and supervision.

Author Contributions

All authors made a significant contribution to the work reported, whether that is in the conception, study design, execution, acquisition of data, analysis and interpretation, or in all these areas; took part in drafting, revising or critically reviewing the article; gave final approval of the version to be published; have agreed on the journal to which the article has been submitted; and agree to be accountable for all aspects of the work.

Disclosure

All authors have no competing interests to report.

Additional information

Funding

This work was supported by the Scientific Research Fund of Wuhan in Hubei Province (WX16C33).