| Objectives:1.To assess the "over diagnosis" among patients with smear-negative pulmonary tuberculosis,we review the diagnosis of patients with the first diagnosis of smear-negative pulmonary tuberculosis in 15 districts in Yunnan Province,and analyze the results of the expert panel imaging review results of patients with negative pathogenesis pulmonary tuberculosis.We also explored the factors influencing "over diagnosis"among patients with smear-negative tuberculosis,and provided suggestions and references for reducing "over diagnosis" among patients with smear-negative tuberculosis and correctly assessing the burden of tuberculosis in Yunnan Province.2.Through personal interviews,we learned about the mastery and application of TB diagnostic principles by clinicians at the district levels,the difficulties of clinicians in the process of TB diagnosis,and the preventive measures taken by hospitals and departments to prevent "over diagnosis" in the process of diagnosis of smear-negative TB.The study will provide a reference basis for reducing "over diagnosis" of smear-negative pulmonary nodules.Methods:1.562 patients first diagnosed with smear-negative pulmonary TB in 15 counties and districts of Yunnan Province(Songming County,Anning City,Hongta District,Jiangchuan District,Chengjiang City,Tonghai County,Huaning County,Yimen County,Eshan County,Xinping County,Yuanjiang County,Zhaoyang District,Zhenxiong County,Simao District,Longyang District)between 2016 and 2020 were used as study subjects,and basic personal information,Laboratory test results(sputum culture,GeneXpert test,strain identification)and chest imaging data before and after anti-tuberculosis treatment were collected.An expert panel of three provincial clinicians reviewed the chest imaging data of the study subjects before and after anti-tuberculosis treatment for comparison and collected the results of the review.The diagnosis of the study subjects was reviewed based on the laboratory test results and imaging results,and patients with positive sputum culture or molecular biology test results were considered as confirmed cases of pulmonary tuberculosis according to the WS288-2017 Diagnostic Criteria for Tuberculosis.With pathogenic negative(sputum culture and molecular biology test results were negative)patients whose imaging review results were "active tuberculosis" were considered as clinically diagnosed cases of tuberculosis.Patients with pathogenic negative and "inactive tuberculosis" imaging results,or patients with strain identification results of NTM are considered as "over diagnosed".The data were entered in EpiData 3.1 and statistically analyzed using SPSS 20.0.The differences in the distribution of patients with "over diagnosis" of smear-negative pulmonary tuberculosis among 18 variables were statistically tested using chi-square test,and multi-factor analysis was performed using dichotomous logistic regression.A chi-square analysis and the kappa value was used to examine the differences in imaging review results before and after anti-tuberculosis treatment in patients with negative pathogenesis pulmonary tuberculosis.The kappa value were used to evaluate the consistency of the results of the first and second readers before and after anti-tuberculosis treatment for clinical diagnosis cases.2.One chief of infection department and two attending physicians or residents of county-level TB designated hospitals in Long yang District and Annng City were selected as the interviewees.After obtaining the consent of the interview subjects,the interview process was recorded,after which all the recorded files were organized into word documents and checked with the field notes to compile the interview records.Then a thematic framework was developed based on the research purpose,interview outline,and interview transcripts,which was categorized and summarized according to the thematic framework to form an overall analysis chart for elaboration.Results:1.The results of sputum culture and molecular biology tests in patients with smear-negative pulmonary tuberculosis showed that 184 patients(32.74%)were positive pathogenesis,indicating that the rate of pathogenic positive among patients with smear-negative pulmonary tuberculosis could be improved by intensive pathogenic testing.2.The results of the diagnostic review of patients with smear-negative TB showed that 513 patients(91.28%)had consistent results,of which 184 patients(32.74%)were judged to be confirmed cases of TB and 329 patients(58.54%)were judged to be clinically diagnosed cases;8.72%of patients had inconsistent results and were smear-negative TB "Over diagnosed" patients.The results of the diagnostic review of pathogenic negative TB patients showed that there were 48 "over diagnosed" patients in this group,with an "over diagnosis"rate of 12.73%.3.The results of the dichotomous logistic regression model analysis showed that CT as imaging modality prior to treatment(OR=3.82,95%CI=1.14-12.77)and smear-negative TB patients with imaging findings suggestive of small lesions(OR=3.24,95%CI=1.40-7.52)had a higher risk of "over diagnosis".4.The difference in imaging review results before and after anti-tuberculosis treatment in patients with negative pathogenesis TB was statistically significant(x2=22.05,P<0.01),indicating that anti-tuberculosis treatment had a corrective effect on imaging review and that anti-tuberculosis treatment could improve the accuracy of imaging diagnosis to some extent.5.In diagnosing patients with smear-negative TB,the diagnostic difficulty expressed by clinicians is differential diagnosis by imaging review.To prevent "over diagnosis" among patients with smear-negative TB,some TB sentinel hospitals have formed TB diagnosis teams to discuss the cases of patients with negative pathogenesis and to agree before making a diagnosis.Conclusions:1.Among the patients first diagnosed with smear-negative tuberculosis in Yunnan Province,there is indeed a problem of "over diagnosis",although the percentage of "over diagnosis" is not high,but because of the large base of tuberculosis patients in Yunnan Province,there are more patients with smear-negative tuberculosis.The existence of "over diagnosis" is a public health problem that cannot be ignored.2.By strengthening pathogenic testing,the proportion of patients with positive pathogens among patients with smear-negative TB can be increased,thus reducing the number of patients who may be "over diagnosed".3.The diagnosis of patients with smear-negative pulmonary tuberculosis depends mainly on imaging,but primary care clinicians may have certain deficiencies in applying CT to diagnose patients with smear-negative pulmonary tuberculosis or patients in the early stage of the disease with small lesions on lung imaging,which may lead to "over diagnosis"and suggest that primary care clinicians should improve their imaging review skills and enhance their ability to discriminate and diagnose patients with smear-negative pulmonary tuberculosis.At the same time,provincial and municipal health departments should increase training on the diagnosis of smear-negative tuberculosis to help primary care clinicians improve their overall level of diagnosis of smear-negative tuberculosis.To reduce "over diagnosis" among patients with smear-negative tuberculosis,clinicians may also form qualified tuberculosis diagnostic teams or administer diagnostic anti-tuberculosis treatment to suspected cases. |
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