The National TB Prevalence Survey Pakistan
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1 The National TB Prevalence Survey Pakistan Preliminary Results 29 th April 2013 Dr Ejaz Qadeer NTP Manager Principal Investigator
2 Background Indicator (2012) Population size GNI per capita (Atlas method) 177M 1120 ($US) Estimated TB Burden (2011) Number Rate Cases (all forms) 620( ) 350( ) Mortality 59 (26 110) 33 (15 60) per 100,000 TB cases with HIV X % N/A Case notifications per 100,000 Treatment success 91 % 2
3 Methodology
4 Sampling design Sample size: 132,393 Number of clusters: 95 Was stratification used? NO <132,393> Target <95> clusters <1400> people 4
5 Prevalence survey cluster sites (95) 5
6 Survey cluster Tehsils Punjab Sindh KP Balochistan GB AJK Total Selected tehsils Extra Tehsils Survey conducted Replacement
7 Selection criteria and health seeking behaviour Inclusion criteria Individuals aged 15 years or older who stayed the night in the household the day before the census Having Informed consent Exclusion Criteria Individuals less than 15 years of age Mental illness No informed consent Screening Positive Criteria for a participant to be eligible to provide sputum for examination Having cough more than two weeks &/OR Having abnormal X-ray shadows. Having cough of any duration who for any reason did not have chest X-ray or whose chest X-ray results are not interpretable OR Who are on TB treatment at time of survey Health seeking behaviour In the indpth questionnaire relevant health seeking behavior questions were asked eg where the patient goes first time to seek care when develop symptoms. 7
8 Laboratory methods Specimen : Two Spot and Morning Smear: Direct smear ( Both specimen) Ziehl-Neelsen ( Both specimen) Spot in field morning in NRL. Culture : On morning specimen only if NA then spot Culture media :Ogawa: Method : SIMPLE without centrifugation Other: How many laboratories used? NRL for All morning specimen (smear+ culture ) Field laboratory for spot specimen - smear Use of GeneXpert MTB/RIF? Yes on positive smears only for ID if culture result NA/CONT/Empty container) Drug sensitivity testing of positive samples? YES ( culture >5 C) HIV testing of participants? NO 8
9 Main Challenges
10 Lessons learned in Pakistan on data processing 1 Data checkers are needed in the field; 2 Reduce the number of forms if possible; 3 The use of the Personal Identification Number (PIN) did not function well in Pakistan instead four names in capture worked well. 4 Interim analyses should be done to give direct feedback to the field during the field team work; 5 Prevalence survey this size should be not paper based. 10
11 Main challenges of survey implementation Procurement Trainings- Staff Retention Logistics 11
12 National Reference Lab Samples received incubator 12
13 Number Annex 1. Annex-I: Sample Size considerations 2. Annex-II: NWFP Tehsil-wise Population Data 3. Annex-III: Survey Identification Card 4. Annex-IV: TB Prevalence Survey Information Sheet 5. Annex-IV (A): TB Prevalence Survey Consent Form 6. Annex-V: Tuberculin Survey Information Sheet for Parents/Guardian 7. Annex-V (A): Tuberculin Survey Parental/Guardian Consent Form 8. Annex-VI: TB Prevalence Survey Census Register for One Household 9. Annex-VII: Tuberculin Survey Census Register for One Household 10. Annex-VIII: Population Listing 11. Annex-IX: Individual Symptom Screening Form 12. Annex-X: Tuberculosis Suspect In-Depth Questionnaire 13. Annex-XI: Suspect Register 14. Annex-XII (A): Chest Radiograph Field Reading and Reporting Form 15. Annex-XII (B): Chest Radiograph Central Reading Form 16. Annex-XIII: Household Characteristics (Asset Score) 17. Annex-XIV: Preliminary Data Analysis Plan Prevalence Survey 18. Annex-XV: Case Assignment 19. Annex-XVI: Follow-Up Questionnaire for Smear Positive Pulmonary TB Cases Registered in NTP Register 20. Annex XVII: Field Laboratory Register 21. Annex-Lab XVIII: Request for Sputum Examination 22. Annex-Lab XIX: Dispatch List: Sputum Examination for Transportation 23. Annex-Lab XX: Laboratory Specimen Dispatch Log Book 24. Annex-Lab XXI: Field Laboratory Cluster Report 25. Annex- Lab XXII: Cluster EQA Report 26. Annex-Lab XXIII: Checklist for Monitoring of Field Laboratory 27. Annex-XXIV: Preliminary Data Analyses Plan: Tuberculin Survey 28. Annex-XXV: List of Standard Operating Procedures (SOPs) for TB Prevalence and Tuberculin Survey 29. Annex XXVI: List of Selected Tehsils and Union Councils 30. Annex-XXVII: Terms of Reference Prevalence Survey Principal Investigator Annex-XXVIII: Terms of Reference Prevalence survey Project Manager 32. Annex-XXIX: Terms of Reference Prevalence Survey Coordinator
14 PIN Personal ID Number (PIN) Is an unique identification key on all forms and registers to identify and merge results of participants 14
15 Procedures and processes PIN cleaning process example 15
16 Recommendations 1. Further correct PINs following written procedures; 2. Further check census register for completeness in database following procedures; 3. Prepare final Annex 17A for merging; 4. DMU to send biweekly updates of progress to KNCV consultants; 5. Define further TA needed. 16
17 Progress Progress data cleaning, April 2013 Jan Febr March April May June PIN cleaning CRL names Census validation Field Lab 17A 17
18 RESULTS
19 Baseline statistics (preliminary) For 49 of 95 clusters (52%) 9% Suspects: 4,981 out of 55,024 Participants: 55,024 (81%) Listed in census register: 69,758 (98%) 49 clusters, total population: 69,758 (~52% of total) 19
20 participation rate 49clusters out of % 90% 80% 70% 60% 50% 40% 30% 20% 10% province urban Female Total 0% 20
21 Data cleaning improvements 100% Improvement in the proportion of subjects with census information 49/95 Clusters Sep-12 80% 60% 40% 20% 0% 21
22 100% Improvement in the proportion of subjects with census information Sep-12 Apr-13 80% 60% 40% 20% 0% 22
23 Laboratory results Any smear positive Any culture MTB S+C+ S+NAAT+ S-C
24 Study cases Smear positive MTB cases Bacteriologically confirmed MTB cases Total number of study cases XX XX Definite case Probable case 27 - Possible case 07 XX Non-study cases XX - Number of cases that are smear positive - XX Definite cases: Probable cases: Possible cases: Non-study cases: <C+ >5C, C+ <5C plus AFB sm+ and/or X-ray +, AFB sm+ plus NAAT+ <2 AFB sm +, 1 AFB sm + plus Xray + ( culture /Naat neg)> < 1 AFB sm+ X-ray Neg > e.g. Culture not MTB positive inc. MOTT/NTM <insert your definition> 24
25 Lessons Learnt
26 Though the analysis is still going.. There is no doubt that we still have high TB burden The survey result is consistent with other recent surveys in Asia except lower proportion of the smear negative cases in Pakistan survey most probably due to the challenges of sputum transportation Molecular tests were useful to diagnose and confirm TB However most smear positive patients in community are detectable even by current TB strategy Case detection is still a challenge in Pakistan Female may have more benefits by culture and new technologies 26
27 Major lessons and implications to the NTP Quality of Data should be Monitored on daily basis by field data checkers. Team Leader is too busy to ensure data quality Data collection Forms should be minimal. 17 Annexes. Data entry and feed back to field team. It took one year after data entry to understand the problem of Mis Merged PINS. Periodic Data quality Audit. 27
28 Acknowledgements 28
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