Jornal Brasileiro de Pneumologia 3 0 (4 ) - Jul/ Ago de 2 0 0 4
Deaths attributed to tuberculosis in the state of Rio de
Janeiro*
LIA SELIG, MÁRCIA BELO, ANTÔNIO JOSE LEDO ALVES DA CUNHA,
ELENY GUIMARÃES TEIXEIRA, ROSSANA BRITO, ANA LUCIA LUNA, ANETE TRAJMAN.
Key words: Tuberculosis. Epidemiology. Program Evaluation
Background: In 1998, tuberculosis incidence and mortality rates in the state of Rio de Janeiro (RJ) were the highest in Brazil. However, the RJ tuberculosis database (SINAN- TB- RJ) has proven unreliable.
Obje ct iv e : To eva lu a t e t h e cu rren t t u b ercu lo sis co n t ro l p ro g ra m b y a n a lyzin g t u b ercu lo sis- a t t rib u t ed d ea t h s.
Methods: Descriptive studies of the SINAN- TB- RJ and tuberculosis mortality (SIM- TB- RJ) databases were carried out. Both databases were linked using the Reclink program. A study based on medical records was performed in the five hospitals where the greatest numbers of tuberculosis deaths occurred.
Results: In the SINAN-TB-RJ database, 16,567 cases were registered in adults (> 14 years of age). Pulmonary disease was present in 13,989 (84.5%), of whom 8223 (56.8%) presented sputum smears that were positive for acid fast bacilli. Anti-HIV testing, recommended for all patients with tuberculosis, was performed in only 4141 (25%) of tuberculosis cases. The SIM-TB-RJ database showed 1146 deaths that were attributed to tuberculosis. Only 478 (41.7%) of those had been reported to the health care system (SINAN-TB-RJ). Among the 302 medical records analyzed, 154 (50.9%) recorded hospitalizations of up to 10 days and 143 (47.3%) had respiratory symptoms for more than 60 days before diagnosis. Among 125 cases of retreatment, the RHZE regimen recommended by the Brazilian Ministry of Health was prescribed for only 43 (34.4%).
Conclusion: This study demonstrates weakness in the RJ tuberculosis control program, characterized by delayed diagnosis, limited use of the recommended tests, poor reporting, and non-compliance with the Ministry of Health guidelines.
*St u dy carried ou t at t he Secret aria de Est ado de Saú de do Rio de J an eiro (Rio de J an eiro St at e Depart men t of Healt h ).
Fin an cially su pport ed by t he FOGARTY Fou n dat ion an d t he Rede Brasileira de Pesqu isa em TB (Rede- TB, Brazilian Tu bercu losis Research Net work); Processo 62.0055/ 01- 4- PACDT- Milen io pelo su port e fin an ceiro
Co rresp o n d en ce t o : Ru a An íb a l d e Men d o n ça , 7 2 / 2 0 2 . Ip a n em a . CEP: 2 2 410 - 0 5 0 Ph o n e: 5 5 2 1 2 5 4 0 8 8 2 8 . E- m a il: lselig @ t erra .co m .b r
RHZE– Rifam pin , ison iazid, pyrazin am ide an d et ham bu t ol SIM – Sistema de Informação de Mortalidade (Mortality database) SINAN – Sist ema de In formação de Agravos de Not ificação (Case- regist ry dat abase)
TB – Tu bercu losis
1998. In 2000, t he in ciden ce of TB in t he cou n t ry was 48.4/100,000 inhabitants, representing 82,249 n ew TB cases, an d t he mort alit y rat e was 3.7/
100,000 in habitan ts.(2) Studies conducted in other
cou n t ries have shown t hat , even u n der adverse socioecon omic con dit ion s, a well- st ru ct u red TB con t rol program (TBCP) can alt er scen arios su ch as t hat fou n d in Brazil.(3)
Dru gs cu rren t ly u sed in t he t reat men t of TB have proven t o be highly efficaciou s. The most recen t st u dy on resist an ce carried ou t in Brazil showed that primary resistance was still uncommon and not responsible for many deaths.(4,5) Therefore, deat h from TB is con sidered preven t able.
In 1998, t he st at e of Rio de Jan eiro had t he highest in ciden ce of t he disease in Brazil (98.8/ 100,000), as well as the highest mortality rate (8.5/ 100,000).(4 ,5 ) Evalu at ion of TBCPs is based on a dat abase called t he Sist ema de In formação de Ag ra vo s d e No t ifica çã o (SINAN, Ca se- reg ist ry Dat abase), which allows t he prin cipal mort alit y in dicat ors t o be calcu lat ed.
Morbidity studies are presently accepted as the gold standard in the assessment of damage caused by a disease. In Rio de Janeiro, findings of TB morbidity studies have been skewed because the
databases have proven unreliable(7). Ferreira, in a study
on mortality caused by acquired immunodeficiency syndrome (AIDS), found that report forms were poorly
filled out and contained typographical errors.(8) In
2000, a review of the 1998 records in the SINAN database for TB in the state of Rio de Janeiro (SINAN-TB-RJ) resulted in the total number of TB cases being revised from 16,001 to 17,351. In the same year, only 15% of case outcomes were registered in the SINAN-TB-RJ database, invalidating any conclusions regarding the TB situation in Rio de Janeiro. A subsequent investigation revealed that 71% of those patients were cured, 19% did not adhere to the
treatment and 7% died.(9)
Mortality is another indicator used in evaluation an d plan n in g. As for TB, t he st u dy of mort alit y was more import an t prior t o chemot herapy, when
a lm o st 5 0 % o f u n t re a t e d ca se s h a d a fa t a l ou t come.(10) Mort alit y st u dies allowed prevalen ce to be estimated. Currently, death from TB is rare in developed cou n t ries. The TB mort alit y rat e is a poor in dicat or of t he ext en t of t he problem sin ce it on ly represen t s t he prevalen ce of t he disease in su b g ro u p s wit h b io p sych o so cial co m o rb id it ies rather than reflecting the magnitude of the disease in t he gen eral popu lat ion . Therefore, deat h from TB shou ld be rare.(11) When su ch a deat h occu rs, it is t ypically represen t at ive of delayed diagn osis, difficulty in gaining access to treatment, or both.(12) The state of Rio de Jan eiro has a higher rate of mort alit y from TB t han an y ot her st at e in Brazil. However, t o dat e, n o syst emat ic st u dies on deat hs attributed to TB have been carried out in the state. Th e o b ject ive o f t h e p resen t st u d y was t o an alyze dat a on deat hs at t ribu t ed t o TB in order t o evalu at e an d propose in t erven t ion s t hat wou ld decrease mortality rates and improve disease control in t he st at e.
METHODS
Jornal Brasileiro de Pneumologia 3 0 (4 ) - Jul/ Ago de 2 0 0 4
TABLE 1
Year of case reporting in the 1 9 9 5 - 1 9 9 8 Rio de Janeiro Case- reg istry database
and deaths reg istered in the 1 9 8 8 Rio de Janeiro Mortality database
Year TB case Deat hs regist ered
was regist ered in 1998 in t he SIM
in t he (t ot al = 1146)
SINAN n (%)
1998 302 (26,4)
1997 104 (9,0)
1996 47 (4,1)
1995 25 (2,1)
Total 478 (41,7)
TB: tuberculosis; SINAM: Sistema de Informação de Agravos d e No t ificação (Case- reg ist ry d at ab ase); SIM: Sist em a d e Informação de Mortalidade (Mortality database)
This was a descriptive study, using data from medical records in combination with information from morbidity and mortality databases. The SINAN-TB- RJ and SIM- SINAN-TB- RJ databases were linked using the Reclink program for the evaluation of variables.(13) As a means of quality control, evaluation of variables was also performed manually.
Data from medical records were collected by medical students from the Faculdade de Medicina da Universidade Gama Filho (Gama Filho University School of Medicine), Fundação Técnica Educacional Souza Marques (Souza Marques Technical Education Foundation) and Fundação Educacional Serra dos Órgãos (Serra dos Órgãos Educational Foundation). The students used a specific investigative instrument (qu est ion n aire), which was design ed t o collect demographic, epidemiological, and clinical data. Students received prior training through classes on ethics, TB- related topics and the theory and practice of scientific investigation, as well as on interpretation of deat h cert ificat es. Three project researchers reviewed the questionnaires in order to verify the consistency of the data collected. The project was submitted to the Ethics Committees of the Hospital Geral da Santa Casa da Misericórdia do Rio de Janeiro (Santa Casa da Misericórdia General Hospital of Rio de Janeiro) and of the Secretaria de Estado de Saúde do Rio de Janeiro (Rio de Janeiro State Department of Health). Both committees approved the project in September of 2000.
Data were stored and analyzed using Epi- Info software, version 6.04. Odds ratios (ORs) was used as estimates of the association between independent variables and mortality. From the ORs, the 95% confidence intervals (95% CIs) were calculated.
RESULTS
Accordin g t o SINAM, 82,931 TB cases were regist ered in Brazil in 1998, 16,990 (20.5%) of which were reported in the state of Rio de Janeiro. Of t hose 16,990 pat ien t s, 16,567 (97.5%) were older t han 14. Median age was 37 years (ran gin g from 15 t o 96) an d 11,173 (67.4%) were male. A t ot al of 14,208 (85.5%) of t he report ed cases an d 2 5 5 (8 4 . 4 % ) o f t h e r e p o r t e d d e a t h s w e r e con cen t rat ed in ju st t en cit ies.
P u lm o n a ry TB wa s d ia g n o se d in 1 3 ,9 8 9 (84.5%) of t he Rio de Jan eiro cases, makin g t hat t he most common presen t at ion of t he disease. Spu t u m smear microscopy was posit ive in 8,223
(56.3%) of pu lmon ary cases an d in 71 of the cases with extrapulmonary involvement. A total of 4,141 p a t ie n t s (2 4 .9 % ) we re su b m it t e d t o h u m a n immu n odeficien cy viru s (HIV) t est in g an d 1,099 (26.5%) t est ed posit ive. Chest X- rays were t aken o f 1 5 ,9 9 7 p a t ien t s (9 6 .5 %). A t o t a l o f 3 ,4 9 5 pat ien t s (21.1%) were hospit alized at t he t ime of diagn osis, an d 190 (5.4%) of t hose pat ien t died. Of t hose 190, 63 (33.2%) were regist ered as TB-relat ed deat hs in t he SIM- TB- RJ dat abase.
Amon g t he 302 deat hs evalu at ed in t his st u dy, 273 (90.3%) had been diagn osed wit h pu lmon ary TB. Bact eriological con firmat ion was posit ively correlat ed wit h mort alit y (OR = 1.63; 95% CI = 1.27 t o 2.08).
Accordin g t o t he SIM- TB dat abase, 6,029 TB-relat ed deat hs occu rred in Brazil in 1998, 1159 (19.2%) of which were reported in the state of Rio de Jan eiro. Of t hose, 1146 (98.9%) were pat ien t s older t han 14. Median age was 50 years, ran gin g from 15 t o 94 years. Of t hese 1146 deat hs, 478 (41.7%) happen ed amon g pat ien t s whose TB was report ed bet ween 1995 an d 1998 (Table 1).
TABLE 2
Factors correlated w ith reporting of the 3 0 2 tuberculosis- attributed deaths studied (Rio de Janeiro, 1 9 9 8 )
Reported Unreported OR
n (%) n (%) (IC 95%)
Diagn ost ic con firmat ion 102 (77,9) 68 (39,8) 5,33 (3,08- 9,27)
HIV t est in g ordered 54 (41,2) 24 (14,0) 4,3 (2,38- 7,78)
OR: odds rat io; 95% CI: 95% con fiden ce in t erval; HIV: hu man immu n odeficien cy viru s
deaths – 2.4%) and Hospital Estadual Getúlio Vargas (Getúlio Vargas State Hospital; 17 deaths – 1.4%). In 1062 (92.7%) of these cases, pulmonary or respiratory TB was listed as the cause of death without having been confirmed bacteriologically or histologically (International Classification of Diseases - ICD A16.2 and A16.9). Pulmonary TB had been confirmed (ICD A 15.0) in only 9 (0.8%) of the 1146 patients.
A sample consisting of 302 medical records was compiled from t he regist ries of t he five hospit als where t here were t he great est n u mbers of deat hs and where the 1998 files were available. The median in t erval bet ween t he on set of sympt oms an d TB diagn osis was 60 days (ran ge, 7 t o 730 days). Sympt oms were presen t for more t han 28 days in 81.7% of pat ien t s, an d for more t han 60 days in 47.3%. A total of 297 patients were diagnosed with pu lmon ary in volvemen t (277 wit h pu lmon ary TB an d 20 wit h pu lmon ary + ext rapu lmon ary TB). Spu t u m smear microscopy was performed in 200 (67.3%), an d 168 (84%) of t hose t est ed posit ive. On ly 2 5 p a t ie n t s (8 .3 % ) we re su b m it t e d t o Myco b a ct eriu m t u b ercu lo sis cu lt u re, a n d 1 8 (72.0%) of t hose t est ed posit ive. Cu lt u re was n ot p e r f o r m e d in a n y e x t r a p u lm o n a r y c a s e s . Su scept ibilit y t est s were performed in 14 (77.8%) of the 18 positive cultures, and resistance to some dru gs was fou n d in 12 (85.7%). In 78 pat ien t s (25.8%), HIV testing was performed and 17 (21.8%) t est ed p o sit ive. Rep o rt in g o f ca ses wa s m o re common when t he diagn osis was con firmed by some method and when HIV- testing was performed (35.3% an d 13.6%, OR = 3.45; 95% CI = 1.85 t o 6.50) (Table 2).
patients, 28 (35.4%) were submitted to retreatment two or more times. Culture was performed in 23 (18.4%) of the 125 retreated patients. The therapeutic regimen recommended by the Health Ministry for retreatment – rifampin, isoniazid, pyrazinamide, and ethambutol (RHZE) – was used in 43 (34.4%) cases. Data on comorbidities were found in 221 (73.2%) medical records: smoking was reported in 143 (64.7%) cases and alcoholism in 141 (63.8%) cases.
DISCUSSION
Ch a o t ic u rb a n iza t io n , t h e m a jo rit y o f t h e population living in urban zones (96.4% in 2000 – the highest in the country) and deficiencies in the public health system are probable reasons for the greater proportion of TB cases in Rio de Janeiro in comparison with other states.(14)
Jornal Brasileiro de Pneumologia 3 0 (4 ) - Jul/ Ago de 2 0 0 4
Pulmonary TB, the most common form of the d isea se, p erp et u a t es d isea se t ra n sm issio n a n d p resen t s h ig h m o rt a lit y ra t es. Sp u t u m sm ea r m icro sco p y sh o wed less p o sit ive resu lt s t h a n expected, considering that, for the diagnosis of TB, t h e He a lt h Min ist ry g u id e lin e s re co m m e n d performing two sputum smear microscopy tests, which increases sensitivity to 80%.(19) Watanabe and Ruffino-Neto, in a study on TB conducted in Ribeirão Preto (in the State of São Paulo), also reported few posit ive spu t u m sm ears.(2 0 ) As for HIV t est in g, considering the World Health Organization (WHO) gu idelin es, which recommen d t hat all pat ien t s diagnosed with TB be tested for HIV, it is alarming that 74% of the patients diagnosed with TB were not tested.(21) It is possible that, in several of the reported cases of patients who had been submitted to treatment for 6 months, had not adhered to treatment or had died, those patients were unaware of the fact they were HIV positive. It is also important to highlight that 6.2% of the HIV tests given were negative and 6.6% were positive, leading us to b elieve t h a t p rio r in vest ig a t io n , ra t h er t h a n diagnostic investigation at the moment of admission, was responsible for the testing. In addition, 96.5% of the patients were submitted to chest X- rays, demonstrating that the ease of access to this more costly diagn ostic tool often leads physician s to forego sputum smear microscopy. Although it is im p o rt a n t t h a t a ll p a t ien t s wit h a su sp ect ed diagn osis of TB be su bmit t ed t o chest X- rays, bacteriological confirmation is essential.
Tuberculosis diagnosis and treatment must be carried out in clinics. Therefore, Rio de Janeiro hospitals should not be the main focus of the TBCP-RJ. However, in 1998, 21.1% of TB patients were hospitalized. Recommendations on epidemiological surveillance including biosafety, laboratories, and case- referral systems, are also essential in order to control TB in hospitals and protect medical staff.(22) It is important to realize that, according to the SINAN database, 190 patients died. However, only 63 of those were also included in SIM- TB- RJ. Since patients are only included in SIM- TB- RJ when the cause of death was definitely attributable to TB, we assu me t hat t he ot her 127 pat ien t s died from comorbidities or from causes other than TB.
The relat ion ship of mort alit y an d pu lmon ary TB to positive sputum smear microscopy reinforces the importan ce of makin g this grou p of patien ts a
priorit y in t he direct ly observed t reat men t , short -cou rse (DOTS). The WHO has recommen ded u sin g DOTS for TB con t rol.(23)
The percentage of deaths registered in the SIM-TB- RJ database in relation to the total number of deaths in the country was similar to the percentage of cases in Rio de Janeiro in relation to the total number of cases in the country (19.2% and 20.5%, respect ively). In 1999, San t o report ed t hat , in addition to the 1157 deaths recorded in the SIM- RJ database, there were 372 additional SIM- TB-related deaths in the state, increasing the mortality ra t e f ro m 8 . 4 / 1 0 0 , 0 0 0 t o 11 . 1 / 1 0 0 , 0 0 0 inhabitants.(23) Of these, most were older than 14 years of age (98.9%), which seems to reflect an effective immunization program, protecting children from tuberculous meningitis and disseminated TB, the most common causes of childhood mortality. The most important finding in the present study, the one that most caught the attention of the TBCP-RJ staff, was that only 478 (41.4%) of the 1146 patients who died represented reported cases. Since it is n ecessary for pat ien t s t o be regist ered as reported cases in order to obtain anti- TB medication from basic health units, we can assume that most patients died without ever receiving any medication from these units. Case reporting is also mandatory in hospitals, which have medication on hand only for t he in it ial t reat men t . If t here is n eit her an epidemiological surveillance unit nor a TBCP in a hospital, the reporting of cases and the referral of patients to a basic health unit will depend on the staff rather than on the institutional protocol.(25) In a study conducted in São Paulo in 1996, Galesi reported that only 35.8% of deaths attributed to TB had been reported.(26)
Most patients (979 – 85.4%) of those who died in Rio de Jan eiro died in hospit als, bu t on ly 63 of t hese cases had been report ed. Therefore, at least 4411 (26.6%) TB pat ien t s were hospit alized in Rio de Janeiro, 3495 of these were reported to SINAN, an d 916 of t hese were n ot report ed t o SINAN bu t died in hospit als, which rein forces t he import an ce of in vest men t in TBCPs in hospit als.(27)
seldom performed. Spu t u m cu lt u re is especially recommen ded when spu t u m smear microscopy is n egat ive, when t here is a su spect ed diagn osis of e xt ra p u lm o n a ry TB, o r w h e n re s is t a n c e is suspected, for example, when critical patients have t o be ret reat ed du e t o relapse or n on complian ce. Even u n der t hese sit u at ion s, cu lt u res were n ot performed – despit e Healt h Min ist ry an d WHO recommendations – and neither were susceptibility t est s. Test resu lt s an d t he n on complian ce wit h official gu idelin es in dicat e t hat a specific st u dy on resist an ce t o an t i- TB dru gs is u rgen t so t hat t he dimen sion s of t he damage can be properly assessed. Albu qu erqu e su ggest ed t he same in a st u dy on t herapy ou t comes con du ct ed in Recife (in the state of Pernambuco).(28) It has been shown, empirically, t hat physicians do n ot ask for t est s whose results they do not expect to receive, which may explain the small number of cultures requested. In accordance with the findings of other studies,(29) t he rat e of HIV t est in g fou n d in t he sample we st u died was also low, even amon g t hose pat ien t s with extrapulmonary involvement.
Two in t erest in g o b servat io n s can b e m ad e regardin g len gt h of hospit alizat ion . On t he on e hand, only 21.2% of the patients were hospitalized for 24 hou rs or less, showin g t he severit y of t he disease. On t he ot her han d, it is su rprisin g t hat t he ou t come for most lon g- t erm hospit alizat ion s was mort alit y. There is a short age of hospit al beds in t he st at e of Rio de Jan eiro, n ot on ly for TB pat ien t s bu t also for pat ien t s in gen eral. It seems t hat t he available beds are n ot bein g allocat ed in an opt imal fashion , a fact t hat was report ed in a st u dy carried ou t in referen ce hospit als.(30) Mean hospital stay in these hospitals was 44 days, versus 71.3 days in hospit als in São Pau lo.(31)
The presen t st u dy also con firmed previou sly d e m o n s t r a t e d h ig h r a t e s o f t r e a t m e n t n on complian ce in t he st at e. Delayed diagn osis, noncompliance with treatment, and underreporting of cases to epidemiological surveillance groups are all fact ors t hat perpet u at e t he disease.
an d alcoholism ran ked first in t he list of problems iden t ified in ou r st u dy. Albu qu erqu e, in a st u dy carried ou t in Recife, emphasized t hat alcoholism is a risk fact or for u n favorable ou t come.(28) An y st rat egies for mort alit y preven t ion an d TB con t rol mu st in clu de act ion s in volvin g t hese t wo fact ors. Ca se rep o rt in g co rrela t ed p o sit ively wit h bacteriological confirmation and with HIV testing, which makes us assume that these good practices are related. It is possible that able and committed professionals follow the guidelines despite the problems, reporting t he case, as well as requ est in g bact eriological confirmation and HIV testing. In light of this, continuing education programs must be considered worthwhile.
One of the limitations of the present study was the poor quality of the data contained in databases an d medical records. Approximat ely 200 records in t he SIM- TB- RJ dat abase were missin g pat ien t names, and the data therefore had to be requested from city authorities. Inconsistencies, duplications, in complet e records an d lack of u pdat in g, as well as the methods used in the collection of some data, su ch a s le ve l o f e d u ca t io n a n d re a so n f o r h o sp it alizat io n , n eg at ively affect ed o u r st u d y. Regist ries of medical records were disorgan ized, makin g t heir u se as a dat a sou rce very difficu lt .
Th e p a rt icip a t io n o f m e d ica l st u d e n t s in o p e ra t io n a l st u d ie s a llo w e d t h e m t o b e g in participating in scientific research and health care strategies. In this study, the students were afforded the opportunity of becoming familiar with one of the greatest public health problems. The indignation that arose among the students over the course of this study motivated them to form the Liga Científica de Tuberculose (Tuberculosis Science League), which has allowed students to participate in the TBCP- RJ, as well as in various research and outreach projects.(32)
ACKNOWLEDGEMENTS
Jornal Brasileiro de Pneumologia 3 0 (4 ) - Jul/ Ago de 2 0 0 4
of Johns Hopkins University. This study received financial support from the Fogarty Foundation and from the Conselho Nacional de Desenvolvimento Científico e Tecnológico (CNPq, National Counsel for Scientific and Technological Development – grant no. 471863/2001-7).
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