<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04434976</url>
  </required_header>
  <id_info>
    <org_study_id>KY-2019TB-20</org_study_id>
    <nct_id>NCT04434976</nct_id>
  </id_info>
  <brief_title>Delayed Diagnosis of Bacteriologically Positive Pulmonary Tuberculosis and Relative Optimized Suggestions in China</brief_title>
  <official_title>Delayed Diagnosis of Bacteriologically Positive Pulmonary Tuberculosis and Relative Optimized Suggestions in China</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Huashan Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Huashan Hospital</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the study is to collect health-seeking pathways, sociodemographic&#xD;
      characteristics and symptoms of 400 newly diagnosed patients with bacteriologically confirmed&#xD;
      pulmonary tuberculosis(TB).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This research is a retrospective, multicenter, case-control study. The purpose of this study&#xD;
      is to collect and assess health-seeking pathways, sociodemographic characteristics and&#xD;
      symptoms of 400 newly diagnosed patients with bacteriologically confirmed pulmonary&#xD;
      tuberculosis(TB).&#xD;
&#xD;
      According to inclusion criteria and exclusion criteria, a total of 400 participants with&#xD;
      bacteriologically confirmed TB will be recruited and acquired their health-seeking pathways&#xD;
      in different clinical institutions of pulmonary tuberculosis. Totally, 20 TB-designated&#xD;
      medical institutions will be conducted in depth, covering the eastern region (7), the central&#xD;
      region (8) and the western region (5), each hospital will enroll 20 eligible patients on the&#xD;
      basis of convenience.&#xD;
&#xD;
      The cohorts are divided into delayed diagnosis and undelayed diagnosis. The former is defined&#xD;
      if The length from the first clinical visit date to the diagnosis confirmed date is more than&#xD;
      14 days. Diagnosis is confirmed by any positive result of anti fast bacteria smear, culture,&#xD;
      histological test, and molecular detection such as GeneXpert. By offline or online interview,&#xD;
      we aim to collect basic sociodemographic characteristics, symptoms, health-seeking pathway,&#xD;
      including: hospital name, the date of each visit, laboratory tests and radiology evaluation&#xD;
      results, diagnosis, treatment, medical and transportation costs. Then list the hospitals of&#xD;
      previous consultations and trace their classification through the official website of the&#xD;
      Health and Medical Commission. Determine whether these hospital are designated institution&#xD;
      based on the CDC's publicity. Consult the laboratory facilities by phone.&#xD;
&#xD;
      The primary objective is to gain the median time of pulmonary tuberculosis diagnosis&#xD;
      confirmed and the correlation between the classification of the first-visit-institution and&#xD;
      the diagnosis delay of the pulmonary tuberculosis.&#xD;
&#xD;
      The secondary objective is to gain the bacteriology examination coverage rate: anti fast&#xD;
      bacteria smear, tuberculosis culture, and GeneXpert; the correlation between the use of&#xD;
      fluoroquinolones as anti-infection treatment before tuberculosis diagnosis confirmed and the&#xD;
      diagnosis delay of the pulmonary tuberculosis; the sociodemographic characteristics of&#xD;
      patients with or without pulmonary tuberculosis diagnosis delay; The rates of onset symptoms&#xD;
      and its correlation to diagnosis delayed of pulmonary tuberculosis diagnosis confirmed&#xD;
      patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 8, 2019</start_date>
  <completion_date type="Actual">January 10, 2020</completion_date>
  <primary_completion_date type="Actual">November 2, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>The median time of pulmonary tuberculosis diagnosis confirmed</measure>
    <time_frame>immediately after asking the medical history and collecting the result of TB diagnosis</time_frame>
    <description>Time from the date of patients' symptoms onset to the date of pulmonary tuberculosis diagnosis confirmed</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The correlation between the classification of the first-visit-institution and the diagnosis delay of the pulmonary tuberculosis</measure>
    <time_frame>immediately after asking the medical history and collecting the result of TB diagnosis</time_frame>
    <description>We collect the classification and the quality of the first-visit-institution of diagnosis confirmed patients by asking the past medical histories. According to the evidence of duration from symptoms onset to pulmonary TB diagnosis confirmed, use logistic correlation to find the relation between the classification of the first-visit-institution and the diagnosis delay.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Bacteriology examination coverage rate: anti fast bacteria smear, tuberculosis culture, and GeneXpert.</measure>
    <time_frame>immediately after asking the medical history and collecting the result of TB diagnosis</time_frame>
    <description>According to the patients' health-seeking pathways, calculate the test coverage rates including anti fast bacteria smear, tuberculosis culture, and GeneXpert in different clinical institutions. The test coverage rates is acquired by recording the laboratory test reports in medical systems or paper version from patients.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The correlation between the use of fluoroquinolones as anti-infection treatment before tuberculosis diagnosis confirmed and the diagnosis delay of the pulmonary tuberculosis</measure>
    <time_frame>immediately after asking the medical history and collecting the result of TB diagnosis</time_frame>
    <description>We collect the fluoroquinolones use evidence of each patients in different clinical institutions by asking the past medical histories and reviewing paper reports from patients as well as medical system. Then use logistic correlation to find the relation between the fluoroquinolones use history and the diagnosis delay of the pulmonary tuberculosis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The sociodemographic characteristics of patients with or without pulmonary tuberculosis diagnosis delay.</measure>
    <time_frame>immediately after asking the medical history and collecting the result of TB diagnosis</time_frame>
    <description>Calculating the distribution of patients' sociodemographic characteristics and correlation between results above and pulmonary tuberculosis diagnosis delay. Patients' sociodemographic characteristics includes: age, sex, marriage status, nation, occupation, education status, annual family income per capita, underlying disease such as diabetes, habits of smoking and habits of drinking alcohol.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The rates of onset symptoms and its correlation to diagnosis delayed of pulmonary tuberculosis diagnosis confirmed patients.</measure>
    <time_frame>immediately after asking the medical history and collecting the result of TB diagnosis</time_frame>
    <description>According to the past medical history of each pulmonary tuberculosis diagnosis confirmed patients, we collect their onset symptoms and calculate the rate respectively. Then use logistic correlation to find the relation between the onset symptoms and the diagnosis delay of the pulmonary tuberculosis.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">400</enrollment>
  <condition>Tuberculosis; Pulmonary, Confirmed, Unspecified Means</condition>
  <arm_group>
    <arm_group_label>delayed diagnosis</arm_group_label>
    <description>The length from the first clinical visit date to the diagnosis confirmed date is more than 14 days. Diagnosis is confirmed by any positive result of anti fast bacteria smear, culture, histological test, and molecular detection such as GeneXpert.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>undelayed diagnosis</arm_group_label>
    <description>The length from the first clinical visit date to the diagnosis confirmed date is equal or less than 14 days. Diagnosis is confirmed by any positive result of anti fast bacteria smear, culture, histological test, and molecular detection such as GeneXpert.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        In the study, 400 patients with bacteriologically confirmed pulmonary tuberculosis(TB) were&#xD;
        chose from 20 hospitals, each hospital select 20 patients according to the eligibility&#xD;
        criteria randomly. These 20 TB-designated medical institutions are covering the eastern&#xD;
        region (7), the central region (8) and the western region (5) among China.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Bacteriological positive: including positive AFB smear/ culture / molecular test;&#xD;
&#xD;
          -  Agree to accept this survey;&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  HIV antibody positive and AIDS patients;&#xD;
&#xD;
          -  Combined with extrapulmonary TB;&#xD;
&#xD;
          -  Critically ill patients, and according to the judgment of the research physician, it&#xD;
             is impossible to survive for more than 16 weeks;&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>15 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Wenhong Zhang, PHD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Huashan Hospita</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Anhui Province Hospital</name>
      <address>
        <city>Hefei</city>
        <state>Anhui</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Third People's Hospital of Shenzhen</name>
      <address>
        <city>Shenzhen</city>
        <state>Guangdong</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Beihai Tuberculosis Hospital</name>
      <address>
        <city>Beihai</city>
        <state>Guangxi</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Guiyang Public Health Clinical Center</name>
      <address>
        <city>Guiyang</city>
        <state>Guizhou</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The 2th Hospital of Daqing</name>
      <address>
        <city>Daqing</city>
        <state>Hei Longjiang</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Henan Province Infectious Diseases Hospital</name>
      <address>
        <city>Zhengzhou</city>
        <state>Henan</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wuhan Medical Treatment Center</name>
      <address>
        <city>Wuhan</city>
        <state>Hubei</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The First People's Hospital of Huaihua</name>
      <address>
        <city>Huaihua</city>
        <state>Hunan</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The First People's Hospital of Taicang</name>
      <address>
        <city>Taicang</city>
        <state>Jiangsu</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Xuzhou Infectious Diseases Hospital Huimei Liu</name>
      <address>
        <city>Xuzhou</city>
        <state>Jiangsu</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jiangxi Province Chest Hospital</name>
      <address>
        <city>Nanchang</city>
        <state>Jiangxi</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Changchun Infectious Diseases Hospital</name>
      <address>
        <city>Changchun</city>
        <state>Jilin</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shandong Province Chest hospital</name>
      <address>
        <city>Jinan</city>
        <state>Shandong</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>905th Hospital of PLA Navy</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shanghai Public Health Clinical Center</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Xian Chest Hospital</name>
      <address>
        <city>Xian</city>
        <state>Shanxi</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Southwest Medical University Affiliated Hospital</name>
      <address>
        <city>Luzhou</city>
        <state>Sichuan</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Qiubei People's Hospital</name>
      <address>
        <city>Qiubei</city>
        <state>Yunnan</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hangzhou Red Cross Hospital</name>
      <address>
        <city>Hangzhou</city>
        <state>Zhejiang</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wenzhou Central Hospital</name>
      <address>
        <city>Wenzhou</city>
        <state>Zhejiang</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <results_reference>
    <citation>Liu R, Li J, Tan Y, Shang Y, Li Y, Su B, Shu W, Pang Y, Gao M, Ma L. Multicenter evaluation of the acid-fast bacillus smear, mycobacterial culture, Xpert MTB/RIF assay, and adenosine deaminase for the diagnosis of tuberculous peritonitis in China. Int J Infect Dis. 2020 Jan;90:119-124. doi: 10.1016/j.ijid.2019.10.036. Epub 2019 Nov 4.</citation>
    <PMID>31693941</PMID>
  </results_reference>
  <results_reference>
    <citation>Martinez L, Xu L, Chen C, Sekandi JN, Zhu Y, Zhang C, Whalen CC, Zhu L. Delays and Pathways to Final Tuberculosis Diagnosis in Patients from a Referral Hospital in Urban China. Am J Trop Med Hyg. 2017 May;96(5):1060-1065. doi: 10.4269/ajtmh.16-0358. Epub 2017 Feb 13.</citation>
    <PMID>28193742</PMID>
  </results_reference>
  <results_reference>
    <citation>Hogan CA, Puri L, Gore G, Pai M. Impact of fluoroquinolone treatment on delay of tuberculosis diagnosis: A systematic review and meta-analysis. J Clin Tuberc Other Mycobact Dis. 2016 Dec 13;6:1-7. doi: 10.1016/j.jctube.2016.12.001. eCollection 2017 Jan.</citation>
    <PMID>31723692</PMID>
  </results_reference>
  <results_reference>
    <citation>Storla DG, Yimer S, Bjune GA. A systematic review of delay in the diagnosis and treatment of tuberculosis. BMC Public Health. 2008 Jan 14;8:15. doi: 10.1186/1471-2458-8-15.</citation>
    <PMID>18194573</PMID>
  </results_reference>
  <results_reference>
    <citation>Hanson CL, Osberg M, Brown J, Durham G, Chin DP. Conducting Patient-Pathway Analysis to Inform Programming of Tuberculosis Services: Methods. J Infect Dis. 2017 Nov 6;216(suppl_7):S679-S685. doi: 10.1093/infdis/jix387.</citation>
    <PMID>29117350</PMID>
  </results_reference>
  <results_reference>
    <citation>Hanson C, Osberg M, Brown J, Durham G, Chin DP. Finding the Missing Patients With Tuberculosis: Lessons Learned From Patient-Pathway Analyses in 5 Countries. J Infect Dis. 2017 Nov 6;216(suppl_7):S686-S695. doi: 10.1093/infdis/jix388.</citation>
    <PMID>29117351</PMID>
  </results_reference>
  <results_reference>
    <citation>Farhat MR, Jacobson KR, Franke MF, Kaur D, Murray M, Mitnick CD. Fluoroquinolone Resistance Mutation Detection Is Equivalent to Culture-Based Drug Sensitivity Testing for Predicting Multidrug-Resistant Tuberculosis Treatment Outcome: A Retrospective Cohort Study. Clin Infect Dis. 2017 Oct 15;65(8):1364-1370. doi: 10.1093/cid/cix556.</citation>
    <PMID>29017248</PMID>
  </results_reference>
  <results_reference>
    <citation>Lewinsohn DM, Leonard MK, LoBue PA, Cohn DL, Daley CL, Desmond E, Keane J, Lewinsohn DA, Loeffler AM, Mazurek GH, O'Brien RJ, Pai M, Richeldi L, Salfinger M, Shinnick TM, Sterling TR, Warshauer DM, Woods GL. Official American Thoracic Society/Infectious Diseases Society of America/Centers for Disease Control and Prevention Clinical Practice Guidelines: Diagnosis of Tuberculosis in Adults and Children. Clin Infect Dis. 2017 Jan 15;64(2):111-115. doi: 10.1093/cid/ciw778.</citation>
    <PMID>28052967</PMID>
  </results_reference>
  <results_reference>
    <citation>GBD Tuberculosis Collaborators. Global, regional, and national burden of tuberculosis, 1990-2016: results from the Global Burden of Diseases, Injuries, and Risk Factors 2016 Study. Lancet Infect Dis. 2018 Dec;18(12):1329-1349. doi: 10.1016/S1473-3099(18)30625-X.</citation>
    <PMID>30507459</PMID>
  </results_reference>
  <results_reference>
    <citation>Mijiti P, Yuehua L, Feng X, Milligan PJ, Merle C, Gang W, Nianqiang L, Upur H. Prevalence of pulmonary tuberculosis in western China in 2010-11: a population-based, cross-sectional survey. Lancet Glob Health. 2016 Jul;4(7):e485-94. doi: 10.1016/S2214-109X(16)30074-2. Epub 2016 Jun 6.</citation>
    <PMID>27283762</PMID>
  </results_reference>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 14, 2020</study_first_submitted>
  <study_first_submitted_qc>June 14, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 17, 2020</study_first_posted>
  <last_update_submitted>June 14, 2020</last_update_submitted>
  <last_update_submitted_qc>June 14, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 17, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Huashan Hospital</investigator_affiliation>
    <investigator_full_name>Wen-hong Zhang</investigator_full_name>
    <investigator_title>Director of Division of Infectious Diseases</investigator_title>
  </responsible_party>
  <keyword>bacteriologically confirmed pulmonary tuberculosis</keyword>
  <keyword>health-seeking pathways</keyword>
  <keyword>Delayed Diagnosis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tuberculosis</mesh_term>
    <mesh_term>Tuberculosis, Pulmonary</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>We would like to share the study protocol and statistical analysis plan.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_time_frame>The data is available currently without expiry date.</ipd_time_frame>
    <ipd_access_criteria>Please contact y_li11@fudan.edu.cn</ipd_access_criteria>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04434976
org study id: KY-2019TB-20
nct id: NCT04434976
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The purpose of the study is to collect health-seeking pathways, sociodemographic
      characteristics and symptoms of 400 newly diagnosed patients with bacteriologically confirmed
      pulmonary tuberculosis(TB).
This research is a retrospective, multicenter, case-control study. The purpose of this study
      is to collect and assess health-seeking pathways, sociodemographic characteristics and
      symptoms of 400 newly diagnosed patients with bacteriologically confirmed pulmonary
      tuberculosis(TB).

      According to inclusion criteria and exclusion criteria, a total of 400 participants with
      bacteriologically confirmed TB will be recruited and acquired their health-seeking pathways
      in different clinical institutions of pulmonary tuberculosis. Totally, 20 TB-designated
      medical institutions will be conducted in depth, covering the eastern region (7), the central
      region (8) and the western region (5), each hospital will enroll 20 eligible patients on the
      basis of convenience.

      The cohorts are divided into delayed diagnosis and undelayed diagnosis. The former is defined
      if The length from the first clinical visit date to the diagnosis confirmed date is more than
      14 days. Diagnosis is confirmed by any positive result of anti fast bacteria smear, culture,
      histological test, and molecular detection such as GeneXpert. By offline or online interview,
      we aim to collect basic sociodemographic characteristics, symptoms, health-seeking pathway,
      including: hospital name, the date of each visit, laboratory tests and radiology evaluation
      results, diagnosis, treatment, medical and transportation costs. Then list the hospitals of
      previous consultations and trace their classification through the official website of the
      Health and Medical Commission. Determine whether these hospital are designated institution
      based on the CDC's publicity. Consult the laboratory facilities by phone.

      The primary objective is to gain the median time of pulmonary tuberculosis diagnosis
      confirmed and the correlation between the classification of the first-visit-institution and
      the diagnosis delay of the pulmonary tuberculosis.

      The secondary objective is to gain the bacteriology examination coverage rate: anti fast
      bacteria smear, tuberculosis culture, and GeneXpert; the correlation between the use of
      fluoroquinolones as anti-infection treatment before tuberculosis diagnosis confirmed and the
      diagnosis delay of the pulmonary tuberculosis; the sociodemographic characteristics of
      patients with or without pulmonary tuberculosis diagnosis delay; The rates of onset symptoms
      and its correlation to diagnosis delayed of pulmonary tuberculosis diagnosis confirmed
      patients.
observational model: Case-Control
time perspective: Retrospective
measure: The median time of pulmonary tuberculosis diagnosis confirmed
time frame: immediately after asking the medical history and collecting the result of TB diagnosis
description: Time from the date of patients' symptoms onset to the date of pulmonary tuberculosis diagnosis confirmed
measure: The correlation between the classification of the first-visit-institution and the diagnosis delay of the pulmonary tuberculosis
time frame: immediately after asking the medical history and collecting the result of TB diagnosis
description: We collect the classification and the quality of the first-visit-institution of diagnosis confirmed patients by asking the past medical histories. According to the evidence of duration from symptoms onset to pulmonary TB diagnosis confirmed, use logistic correlation to find the relation between the classification of the first-visit-institution and the diagnosis delay.
measure: Bacteriology examination coverage rate: anti fast bacteria smear, tuberculosis culture, and GeneXpert.
time frame: immediately after asking the medical history and collecting the result of TB diagnosis
description: According to the patients' health-seeking pathways, calculate the test coverage rates including anti fast bacteria smear, tuberculosis culture, and GeneXpert in different clinical institutions. The test coverage rates is acquired by recording the laboratory test reports in medical systems or paper version from patients.
measure: The correlation between the use of fluoroquinolones as anti-infection treatment before tuberculosis diagnosis confirmed and the diagnosis delay of the pulmonary tuberculosis
time frame: immediately after asking the medical history and collecting the result of TB diagnosis
description: We collect the fluoroquinolones use evidence of each patients in different clinical institutions by asking the past medical histories and reviewing paper reports from patients as well as medical system. Then use logistic correlation to find the relation between the fluoroquinolones use history and the diagnosis delay of the pulmonary tuberculosis.
measure: The sociodemographic characteristics of patients with or without pulmonary tuberculosis diagnosis delay.
time frame: immediately after asking the medical history and collecting the result of TB diagnosis
description: Calculating the distribution of patients' sociodemographic characteristics and correlation between results above and pulmonary tuberculosis diagnosis delay. Patients' sociodemographic characteristics includes: age, sex, marriage status, nation, occupation, education status, annual family income per capita, underlying disease such as diabetes, habits of smoking and habits of drinking alcohol.
measure: The rates of onset symptoms and its correlation to diagnosis delayed of pulmonary tuberculosis diagnosis confirmed patients.
time frame: immediately after asking the medical history and collecting the result of TB diagnosis
description: According to the past medical history of each pulmonary tuberculosis diagnosis confirmed patients, we collect their onset symptoms and calculate the rate respectively. Then use logistic correlation to find the relation between the onset symptoms and the diagnosis delay of the pulmonary tuberculosis.
arm group label: delayed diagnosis
description: The length from the first clinical visit date to the diagnosis confirmed date is more than 14 days. Diagnosis is confirmed by any positive result of anti fast bacteria smear, culture, histological test, and molecular detection such as GeneXpert.
arm group label: undelayed diagnosis
description: The length from the first clinical visit date to the diagnosis confirmed date is equal or less than 14 days. Diagnosis is confirmed by any positive result of anti fast bacteria smear, culture, histological test, and molecular detection such as GeneXpert.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 15 Years
maximum age: N/A
healthy volunteers: No
last name: Wenhong Zhang, PHD
role: Principal Investigator
affiliation: Huashan Hospita
facility: 
facility: 
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facility: 
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facility: 
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facility: 
country: China
citation: Liu R, Li J, Tan Y, Shang Y, Li Y, Su B, Shu W, Pang Y, Gao M, Ma L. Multicenter evaluation of the acid-fast bacillus smear, mycobacterial culture, Xpert MTB/RIF assay, and adenosine deaminase for the diagnosis of tuberculous peritonitis in China. Int J Infect Dis. 2020 Jan;90:119-124. doi: 10.1016/j.ijid.2019.10.036. Epub 2019 Nov 4.
PMID: 31693941
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responsible party type: Principal Investigator
investigator affiliation: Huashan Hospital
investigator full name: Wen-hong Zhang
investigator title: Director of Division of Infectious Diseases
mesh term: Tuberculosis
mesh term: Tuberculosis, Pulmonary
sharing ipd: Yes
ipd description: We would like to share the study protocol and statistical analysis plan.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd time frame: The data is available currently without expiry date.
ipd access criteria: Please contact y_li11@fudan.edu.cn