(Vol.77. No.1 January 2002) <1> Kekkaku Vol.77, No.1: 3-9, 2002 HOW BEDS FOR TUBERCULOSIS BE PROVIDED AND UTILIZED? Tadao SHIMAO Abstract In 1951 when TB Control Law was legislated, and the government of Japan started intensive TB programme mainly consisting of mass health examination, BCG vaccination and distribution of appropriate treatment for TB cases, there were about 100,000 beds for TB, similar to the number of then TB deaths, and many TB patients died before admission to sanatoria. Urgent measures were taken to increase beds for TB with a target of 250,000, 2.5 times of then TB death. The target was achieved in 1957. Thereafter, the number of beds for TB as well as the occupancy rate had decreased with the decline of TB, and then policy on beds for TB could be summarized as follows:(1) top priority was given to increase the number of beds for TB, (2) general hospitals were improved with the progress of medical science and economic development, while no improvement was done on TB beds with the assumption that the need for TB beds will soon disappear, (3) minimum unit of TB beds was a TB ward with generally 40 to 50 beds, (4) an idea to provide TB bed in a general hospital came out only since 1992 as a small model project, (5) it was intended to segregate infectious TB patients from the community, however, no consideration was made about super-infection among patients themselves and the infection to health care workers, (6) admisson of TB cases to a general bed and admission of non-TB cases to a TB ward was not legally permitted, (7) cost for TB treatment was set on a low level. Recent data indicate that the occupancy rate of TB beds was 43.5%, and the average stay in TB beds is still slightly over 100days, and observing by prefectures, marked differences were seen. Taking into account changes in the pattern on TB patients such as aging and the increase of cases with serious complications and most health care workers in TB wards are not yet infected with TB, it is needed to divide TB beds into two types, one for new cases and the other for chronic cases. Beds for new cases should be provided in principle as a single room in a general hospital with good ventilation system, and DOT should be started in a hospital. Stay in this type of bed should not exceed 2 maonths, and higher medical fee should be provided. Beds for chronic cases could be provided in a TB ward. MDRTB cases are admitted in bed for chronic cases, however, preferably in a single room, and if active intervention such as chest surgery is tried in a few sophisticated hospital, medical fee for acute bed should be applied. Now, we have to change out mind from old concept of beds in TB ward to a TB bed in a single room with good ventilation. Key words :Bed for tuberculosis patients, Hospital tereatment, Utilization rate of hospital bed, Average stay in a hospital Japan Anti-Tuberculosis Association Correspondence to:Tadao Shimao, Japan Anti-Tuberculosis Association, 1-3-12, Misaki-cho, Chiyoda-ku, Tokyo 101-0061 Japan (E-mail:t_shimao@jp.interramp.com) <2> Kekkaku Vol.77, No.1:11-22, 2002 COMPARISON OF EFFECTIVENESS OF BCG VACCINATION AND PREVENTIVE THERAPY IN JAPANESE SETTINGS, WITH SPECIAL EMPHASIS ON THE SENSITIVITY AND SPECIFICITY OF TUBERCULIN TESTING Takashi YOSHIYAMA Abstract Background:BCG vaccination in low prevalence countries is controversial. Most discussions have been done by the comparison of benefit, side effect and cost of BCG vaccination. No discussion has been done on the disadvantage of BCG vaccination from the point of view of loss of sensitivity and specificity of tuberculin test on the diagnosis of LTBI. Method:Theree groups, i.e. the BCG vaccination group with preventive therapy under worsened sensitivity and specificity of tuberculin test due to previous BCG, no intervention group and non BCG vaccination group with preventive therapy under standard sensitivity and specificity of tuberculin test were set up. The target population was a cohort of Japanese who are born at the year with 0.1% annual risk of tuberculous in fection. The TB incidence, TB related mortality (including death by BCG and preventive therapy), TB related loss of DALY (disability adjusted life years), and direct medical cost of the above three groups, for the cohort only and the cohort including secondary TB cases from the clinical cases in the chohort. Results:Under the current program conditions, the merit of BCG vaccination is greater than the merit obtained from the preventive therapy without BCG. Although the medical direct cost is lowest among the preventive therapy group without BCG, next without BCG or preventive therapy and highest among BCG group. Under BCG group, too extensive screening for LTBI does not reduce the loss of TB related DALY, whereas in the non BCG group, extensive screening will help to reduce the loss of TB related DALY and if more extensive screening can be done, the loss of TB related DALY in the non BCG group can be less than that in the BCG group. Conclusion:At present extensiveness of screening for LTBI and BCG vaccination contribute to the reduction of TB and loss of TB related DALY. Possible extensive screening without BCG may be able to reduce loss of TB related DALY in comparison to be BCG vaccination group. Key words :Tuberculosis, BCG vaccination, Preventive therapy, Tuberculin test, LTBI(Iatent tuberculosis infection) Epidemiology Division, Research Institute of Tuberculosis, Japan Anti-Tuberculosis Association Correspondence to:Takashi Yoshiyama, Epidemiology Division, Research Institute of Tuberculosis, Japan Anti-Tuberculosis Association, 3-1-24, Matsuyama, Kiyose-shi, Tokyo 204-8533 Japan (E-mail:yashiyama@jata.or.jp) <3> Kekkaku Vol.77, No.1: 23-27, 2002 CLINICAL INVESTIGATION OF PULMONARY MYCOBACTERIUM KANSASII INFECTION IN OUR HOSPITAL Yoshiaki TAO, Kiyoshi NINOMIYA, Masayuki MIYAZAKI, and Hisamichi AIZAWA Abstract There is evidence that the Number of non-tuberculosis mycobacterium (NTM) cases is increasing at least in some areas of the world and as possible causes of the increase, the followings are pointed out;ageing of the population, improved methods for detecting organisms from clinical specimens, incerased physician's awareness on the disease, increased exposure of patient to the source of the organism. In Japan, it has been estimated that the overall incidence of NTM disease is about 3 per 100,000. About 80% of NTM are MAC, and among the remainder, Mycobacterium kansasii is most common in our country. Our hospital located in Fukuoka prefecture in Kyushu, western part of Japan. In this study, clinical data of 24 cases of pulmonary infection caused by Mycobacterium kansasii in our hospital, from 1996 to 2000 were investigated. Primary infection type patients were younger than secondary infection type. Nearly all secondary infection type patients had underlying diseases and complications. Serum total pretein and albumin in primary type is lower than that in secondary type. The results of mycobacterial drug sensitivity tests were as follows; for rifampicin, 23 cases were sensitive to 10ƒÊg/ml, all cases to 50 ƒÊg/ml, for ethambutol, 15 cases were sensitive to 2.5ƒÊg/ml, 22 cases to 5ƒÊg/ml, and for isoniazid, all cases were resistant to 0.1ƒÊg/ml, 11 cases were senseitive to 1ƒÊg/ml and 23 cases to 5ƒÊg/ml. Sputum cultures of patients treated with drug regimens containing RFP converted to negative within 2 months after starting chemotherapy. Although three patients with serious complications died, other 21 patients improved and showed no relapse at least 6 menths after the completion of treatment. Key words :Mycobacterium kansasii, Clinical investigation, Nontuberculous mycobacteriosis, Pulmonary infection Department of Respiratory Disease, National Fukuoka-higashi Hospital Correspondence to:Yoshiaki Tao, Department of Respiratory Disease, National Fukuoka-Higashi Hospital, 1-1-1, Chidori, Koga-shi, Fukuoka, 811-3115 Japan. <4> Kekkaku Vol.77, No.1: 29-35, 2002 The 76th Annual Meeting Special Lecture A DECADE OF SUCCESSFUL TUBERCULOSIS CONTROL IN NEW YORK CITY: The Role of DOT vs DOTS Paula I. Fujiwara Key words:New York City, Tuberculosis control, DOTS, DOT Introduction I would like to review how New York City (NYC) has faced the problem of tuberculosis (TB), and successfully reduced it currently through the DOTS strategy. My take-home message is that if a place as big and diverse and complicated and crazy as NYC could accomplish what we accomplished, then Japan can too. You may implement activities in a different way, but the principles are the same. Brief History and Background of TB Control in New York City (NYC) Many of the basic precepts of modern tuberculosis (TB) control, including laboratory diagnosis, isolation of infectious cases, reporting of cases to public health authorities, outreach to patients in their homes and public education about tuberculosis, were developed and refined in the late 1800s by Dr. Hermann Biggs of the NYC Department of Health, which is today still responsible for tuberculosis control activities in NYC. He remarked that compared with TB, "all other communicable and reventive diseases sink into relative insignificance". He used the pioneering work of Dr. Robert Koch, who showed that TB was a communicable disease caused by a bacterium and proposed a systematic approach to tuberculosis control. These included: 1) mandatory notification of all TB cases; 2) the use of the acid fast bacillus smear, a highly effective diagnostic tool, to diagnose infectious cases, and provided for free; 3) patient follow-up by nurses to provide the best treatment available at the time - bed rest, fresh air and good nutrition to reduce the spread of transmission, and to provide education about transmission; 4) education of physicians, patients and the public (he had materials translated into German, Hebrew, Italian and other languages), and 5) he strengthened political will to gain financial and administrative support for his programs. He did his work against great resistance by the medical establishment, who opposed mandatory notification as a violation of the doctor-patient relationship. His educational messages had the unintended consequence of stigmatizing the communities that were most affected. On balance, however, his efforts led to the creation of an administrative framework for TB control still applicable today. Sadly, NYC did not heed its own lessons. By the late 1970s and throughout the 1980s, the number of tuberculosis cases started to rise, and almost tripled by early 1990s (Fig.1). There were 4 causes for this resurgence of TB; 1) dismantling of the TB control infrastructure, 2) immunosuppression from HIV, 3) lack of infection control in hospitals, and 4) immigration from high TB prevalence countries. Dismantling of the TB control infrastructure NYC's local government and the US federal government withdrew funding for TB control in the late 1970s and throughout the 1980s. Between 1970-72, the US federal government phased out direct monetary support to cities, and then between 1974-78, NYC underwent a fiscal crisis. In 1979, the state of NY terminated its funding. In 1979, some renewed funding came from the federal government, but a year later, in 1980, this was reduced significantly. In addition, Brudney and Dobkin reported on 224 patients at a NYC inner city hospital serving the poor. Of 224 consecutive patients suspected of TB that were admitted to the hospital, 53% abused alcohol, 64% abused drugs, 68% were homeless or unstably housed, and 50% were HIV positive. Of the 178 discharged from the hospital on treatment, 89% were lost. Staff in the program confirmed that they spent their time finding patients, then would lose them, but no resources were available to track them down again. Immunosuppression from HIV There was a large population of HIV-infected individuals in NYC, who once infected M. tuberculosis, developed TB disease rapidly. About one third of the patients with TB were infected with HIV (Fig. 2). However, because so many of the TB patients did not have an HIV test done, this is a minimal estimate, and we estimate there was approximately 40% co-infection. In 1999, however, this had declined to 22%. Fig.3 shows the data in 1999 stratified by sex. Males are more likely to be documented to be HIV infected. While the HIV status is not known for about 25%, this has declined from the early 1990s when over 50% did not have their status recorded. Lack of Infection Control The lack of infection control in hospitals caused them to become amplification centers for TB. During the NYC's nosocomial outbreaks, the average length of time between diagnosis and death was 4-16 weeks. The outbreaks involved 11 hospitals, where 357 patients met the case definition of resistance to isoniazid, rifampin, ethambutol and streptomycin, and 25% of the MDR-TB cases in the United States occurred in NYC between 1990 and 1993. 267 had identical or nearly identical strains (strain W -resistant to isoniazid, rifampin, ethambutol, pyrazinamide, streptomycin, kanamycin, ethionamide); 86% were HIV-infected; 70% were epidemiologically linked, and 96% were nosocomially transmitted. The outbreaks also infiltrated into the New York State prison system. Since it was the policy of the state prison system to move prisoners around from prison to prison, eventually the strains of TB were seen in 23 of the 56 prisons. Strain W also spread from NYC to more than 40 of the 50 states. The development and continued presence of MDR-TB in NYC reflected the historical neglect of the TB program. The scenario was that patients didn't take the medications properly; the strains developed drug resistance; they continued to be infectious and spread MDR-TB to others, including the health care workers within the hospitals, and also to those in the community. Doctors didn't know how to treat the drug-resistant strains, and created more drug resistance. The patients continued to be infectious and the vicious cycle continued. It is hard to convey the sense of panic, hysteria and crisis that was in NYC at the time. People were dying, including some health care workers who were caring for them. The hospitals were not environmentally safe. The newspapers were full of stories about TB, tourism was affected, and the health department was besieged with calls from professionals and the public. When I was preparing to interview for the position of MDR-TB coordinator in NYC, I sought the advice of colleagues and professors. All discouraged me from taking the position, saying that the bureaucracy of NYC was too difficult to accomplish anything. Immigration from high TB-burden countries Between 1992 and 1999, the proportion of TB cases among the foreign born increased 228%, from 18% in 1992 to 58% in 1999 (Fig.4). By 1997, the number of TB cases reported among the foreign born exceeded that of those born in the US. Fig. 5 shows the cumulative number of foreign-born TB cases. The countries of origin by level of morbidity were Puerto Rico, China, Dominican Republic, Haiti, Ecuador, Mexico and India. Social Characteristics of TB Cases The TB patients in New York City face many challenges in addition to their disease (Table 1). A significant proportion use excessive amounts of alcohol and/or use drugs. Although the number of homeless at the time of diagnosis or during treatment is relatively low, a significant number have had a history of homelessness before diagnosis. There is some risk to health care or correctional workers. Epidemiologic Trends of TB in NYC Fig.‚Pshows the overall trends of TB cases and rates in NYC from 1978 to 1999. TB increased until 1992 but since then has decreased dramatically; the rate went from 50.2 to 19.9/100,000; cases from 3,811 to 1,460, a decline of over 60%. Data for 2000 shows a further decline, and the lowest case rate ever recorded in NYC. Age Distribution of TB Cases by Year The pattern of age distribution of TB cases has changed over the years (Fig.6). Between 1992 and 1999, 69% fewer cases have been reported in the 25-44 year age group. The pattern seen in NYC resembles that in the developing world. From 1992 through 1999, there has been a 69% decline in the 25-44 year age group, i.e. the young and middle-aged adults, as the rate of HIV has declined. Drug Resistance by Previous treatment A survey performed in April 1991 showed that drug resistance was high in NYC (Fig.7). 30% of those who had previously received some treatment for TB, but had not necessarily completed treatment, had TB strains resistant to isoniazid and rifampin, the two most powerful medicines available to treat TB. Among those who had never been treated, 6% were infected with these MDR (Multi drug resistant) -TB strains. In contrast, at the same time in the United States, just 3% of all cases in a national survey had MDR-TB, for which NYC contributed two-third of the cases. MDR-TB (1991-1999) The number of cases of MDR-TB declined dramatically from the peak in 1992 (Fig.8). This was attributable to several factors: 1) the rapid deaths of the outbreak cases, decreasing the time available to spread TB, 2) the improvement in the TB control program, specifically the use of DOT, 3) the intensive case management of those with MDR-TB, and the availability of drugs to treat them. From a peak of approximately 450 cases in 1992, approximately 30 cases were reported by 1999. New cases of MDR-TB have practically been eliminated. However, we are left with a group of chronic cases, almost all HIV negative, who have been unresponsive to all treatment. Three have court orders for home isolation. Directly Observed Therapy (DOT) in NYC One of the key elements in the battle against TB in NYC was the implementation of directly observed therapy (Fig.9). In 1992, when I arrived in NYC, DOT was reserved only for the so-called "difficult" patients. Despite this policy, TB, and especially MDR-TB had spiraled out of control. Numerous studies have shown that it is not possible to predict with any certainty who is going to adhere to taking medications. It has been shown NOT to be correlated with: level of education, socioeconomic status, type of profession, gender, marital status, age, etc. We made the decision, despite great skepticism that it could be done and resistance to the idea that it SHOULD be done, that DOT was a service that would be offered to everyone as the best way to provide treatment. We started in July of 1992, and set a goal of 500 patients on DOT by December. We initiated extensive training of all staff in the program, as embarked on a series of lectures to the medical providers in the community, concentrating on university professors and medical centers, who would be seen as innovators. With their support, they in turn worked within their own institutions to spread the word about DOT. When we reached 550 people on DOT by December 31 of that year, it was a moment of great pride and a realization that we could change attitudes and practice. When the number of cases dropped by 14% the following year, we were ecstatic. Approximately 69% of all patients in NYC have their treatment under DOT. Given the nature of the medical system in the United States, DOT in most instances is voluntary, and we must rely on convincing physicians and patients that this is the most effective method of treatment. Those with MDR-TB are our highest priority, given that this is their last chance for cure. Persons with pulmonary smear positive, that is, infectious TB, are also given high priority. If a person has come to one of the clinics run by the Department of Health of NYC, over 80% have their treatment under DOT. Patients cared for by private doctors have the lowest rate. Implementation of DOT in NYC There have been a various practical points to note in implementing DOTS: 1) In the beginning, we had to overcome intense resistance of physicians and staff; 2) Patient could decide where/when DOT is given; 3) Patients are provided with enablers, longer clinic hours, transportation tokens, and biweekly treatment; 4) Patients are also provided with incentives such as cash equivalents and meals on site. Summary In summary, through our intensive efforts, TB declined significantly in NYC between 1992 and 1999. The new TB cases decreased by 62%. New cases of MDR-TB have been reduced by 93%. US-born cases, particularly among the young to middle aged adults (25-44 years), who were heavily impacted by HIV, have declined by 81%. The proportion of HIV-infected cases decreased from 34% to 22%. However, the proportion of foreign-born cases has more than doubled from 18% to 58%. Good TB Control Program: DOTS in contrast to DOT How did we accomplish the above results? Looking back, we did begin to reapply the principles laid out by Hermann Biggs that I presented earlier. To achieve these results, NYC's TB Control followed the precepts of the pioneering work of Dr. Karel Styblo of the International Union Against Tuberculosis and Lung Disease (IUATLD), who developed it while at the IUATLD. His work was adopted by the World Health Organization, and relabeled by them as the DOTS (Directly Observed Treatment, short-course) strategy. However, naming this strategy DOTS, because of the close link to the concept of DOT, has caused great confusion and misunderstanding. To define them, DOTS is the whole package of five activities that defines good TB control, while DOT is only ONE of the five elements, the actual watching of the patient taking medication of the DOTS strategy package (Table 2). In NYC, we followed these the 5 specific precepts of DOTS, although we did not label it as such at the time. Success of TB Program in NYC The success of TB program in NYC can be explained according to the DOTS components: Political will: The first is POLITICAL WILL. There was strong support from the Commissioner of Health of NYC, the highest-ranking health officer. We lobbied successfully for increased funding from local, state and federal levels (Fig.10). We sought and received support from university professors as "change agents". Laboratory services: We improved the turn around time for results of AFB smear, culture and susceptibility, which was taking sometimes up to 4-6 months. Susceptibility testing was mandated, and surveillance for contamination was implemented. Medication supply: Free medication is available to all. Private doctors can obtain free medications for patients only if the treatment is done on DOT. For some special cases such as those with MDR-TB, experimental drugs are available under the protocol guidelines. Systematic review of TB program results: A system of quarterly cohort reviews of all patients has been established: 1) Review meeting: Oral presentations of the activities are made in group settings by the staff to the program director. The meeting is attended by physicians, nurses, managers and supervisors, out reach workers, social workers who are concerned with the program. Everyone is accountable for the results. The outcomes are tied to national goals and objectives. 2) Review of results: Based on the presentations, the results, mainly of treatment cohort, are calculated and fed back immediately for each case. The results are documented as completed, died, moved or abandoned treatment. The development of new goals is set up by the end of meeting. 3) Outcome of contacts examination: The outcome of contacts to cases is also reviewed, such as number of contacts/case (contact index), number evaluated for TB, number infected with TB, number offered treatment for latent TB infection, number of people who start treatment, number of people who complete treatment. Some sample review results comparing 1992 to 1998 is shown in Table 3. The quality of the program has improved significantly. Does Japan have these elements? As I end this part of the presentation, I want you to ask yourselves: does Japan have these elements? Are they as good as they can be? Lessons learned The lessons learned in NYC can be divided into three types as follows: 1) Regarding TB control infrastructure: a. The health department can serve as a coordinator for all TB control in the community. b. Having a manual for policies and procedures sets the standard for the community c. The health department has some unique responsibilities, such as surveillance, contact investigation, detention or dealing with the most difficult cases. 2) Regarding Patient care: a. TB patients should be the center of all efforts. b. The program should be run on a customer service model: the patient as customer, the doctors as customers, and the public as customer. c. Since so many of the patients with TB are poor and disenfranchised, we as health officials must serve as advocates. d. Following the tenets of Hermann Biggs, education is needed to address stigma at home, school and workplace. 3) Regarding Management: There are some general management principles, not TB specific, that we found useful. a. Leadership is crucial. Leaders set the tone, can inspire staff, and look ahead to see what future challenges are. b. There needs to be a strong sense of mission. c. Investing in staff will pay the program back many times over: hiring the appropriate staff, training and supervising them, as well as allowing for their professional growth. d. Everyone from the clerk to the director should be held accountable for results. e. Results should be analyzed and reviewed on a consistent basis, and new projects and initiatives should be developed from the findings. The road ahead The work is not yet done in New York. We need the following: 1) to address the needs of the foreign born, with their different cultural, linguistic and belief systems; 2) to improve our collaboration and coordination with the private sector; 3) to remember the U-shaped curve of concern, so we maintain the infrastructure of TB control; and 4) to maintain the sense of urgency and mission that helps to fuel the work. Conclusion We have come a long way, but there is still much to accomplish. What are the lessons for Japan? Fortunately, the goals of TB control are the same everywhere: that persons with TB are diagnosed promptly and treated until cure. That these patients are cured is a concern for all of us, for we are all connected by the air we breathe. Each person cured of infectious TB eliminates a source of other cases, safeguarding the rest of the community. To come full circle from the beginning of this presentation, I conclude with the words of Hermann Biggs, whose principles for TB control and thoughts are still relevant today: "Public health is purchasable. Within natural limitations a community can determine its own death rate." We did it in NYC. And if it can be done there, Japan can do it too. Former Director, New York City Tuberculosis Control Program Deputy Executive Director, International Union Against Tuberculosis and Lung Disease Correspondence to:Paula I Fujiwara. IUATLD, 68 boulevard Saint-Michel 75006 Paris, France (E-mail:pfujiwara@attglobal.net) (Received 18 Oct. 2001)