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NEW CHALLENGES IN AMBULATORY CARE OF TUBERCULOSIS* LEE B. REICHMAN, M.D., M.P.H.t Associate Professor of Medicine New Jersey Medical School Chief, Pulmonary Division Martland Hospital Newark, N.J.
ONE way to look at tuberculosis is as a prism through which the deficiencies in health-care delivery can be viewed. It is the only disease in the nation's top causes of death that medical science now has the wherewithal to handle. Much of the basic research has been done. The transmission and pathogenesis are understood. The treatment can be successful in almost all patients who take their drugs faithfully. The national case rate, however, is still about 14 per 100,000 population and there are still close to 3,800 deaths due to tuberculosis. The national figures give a false sense of security. If we look into the inner-city ghetto populations we still find incredible rates for this day and age. These data would be even more alarming if we did not have access to information about previous years like 1960 when the rate in Central Harlem was 252 cases per 100,000 population. The rate for New York City as a whole in 1940, long before isoniazid was discovered, was 130 per 100,000, or about equal to the 1971 rate in Harlem. That such populations retain a very high case rate of tuberculosis in 1975 suggests that we must be experiencing deficiencies in the delivery of health care to tuberculous patients. I shall suggest briefly what the problem is and what can be done about it. It is hoped that these remarks will be refreshing, because the solution is no more expensive than what we are now doing. First we must make some basic assumptions. These are based on good evidence and faith. We may hope they will lead us to the workable solutions which we need in the problems of delivering care to tuberculous outpatients. *Presented as part of a Symposium on Selected Aspects of Pulmonary Disease held by the Section on Medicine of the New York Academy of Medicine March 3, 1976. tSupported by Pulmonary Academic Award No. 5 K07 HL 00124-02 from the National Heart, Lung, and Blood Institute, Bethesda, Md. Address for reprint requests: Mardand Hospital, 65 Bergen Street, Newark, N.J. 07107.
Bull. N. Y. Acad. Med.
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The first assumption we must make is that almost all tuberculosis can be treated on an outpatient basis if a suitable interest in delivering care and motivating patients exists. A corollary is that the only indication for hospitalization for tuberculosis is illness in the patient. Another corollary that I have come across in heading the recent Task Force to Consider the Future of the New Jersey State Hospital for Chest Diseases-we recommended its closure, which occurred last year-is that the existence of a state facility (read "sanatorium" or "dumping ground") which permits tuberculosis care and control to be taken out of the mainstream of medical care can militate against the development of a viable system for delivering tuberculosis health care in both the public and private sectors of medicine. If all acutely ill patients are sent to the sanatorium, there is no need for private physicians to become adept at the treatment of this disease and to face their responsibility to participate meaningfully in the management of tuberculosis, with the use of general hospitals when necessary. One other assumption, obvious to those who care for tuberculosis patients, is that some patients are more concerned with the other problems of their lives than with their tuberculosis. Many are alcoholics or drug addicts. They are poor people who have difficulty finding homes, getting work, or keeping their families together. Their tuberculosis certainly is not of as much concern to them as their other personal problems. The delivery system for tuberculosis care must take this factor into account and must meet it along with the other deficiencies in tuberculosis care. The outpatient system must conform to the patient and not vice versa. There are many opportunities for innovation in delivering this care. Categorical outpatient care systems which are updated are expensive. As morbidity and mortality from this disease decrease its importance as a national health problem diminishes. Practical and political considerations divert national, state, and local jurisdictional funding of health programs to more newsworthy priorities. Voluntary tuberculosis associations are now lung associations. Federal project grants specifically for tuberculosis programs have been discontinued and jurisdictions now use local funds or vie for federal block grant funds to the exclusion of other programs. We have found, however, that we really might not need outside help. Such aid may be counterproductive. It is far more important to redesign priorities within tuberculosis-control programs now to make them self-sufficient. To introduce some of these concepts leading to new priorities I shall describe the programs I carried out when I was with the New York City Vol. 53, No. 6, July-August 1977
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Department of Health from 1971 to 1973. These were all done without the infusion of new funds. In 1971 at the New York City Department of Health the problem had already been defined by an earlier task-force report. There were still 2,500 new active cases and 400 deaths. There were 30 clinics divided into two types. Eight of these were located in hospitals and supported directly under project grant funds from the federal government. These were "combined clinics" reflecting combined input from the New York City Department of Health, The Health and Hospitals Corporation, and a federal project grant. Each clinic had a clinic manager and was staffed medically by internists and house staff. They were administered by U. S. Public Health Service advisors who were separated from the Bureau of Tuberculosis and had their own office and staff. The 22 "have-not" clinics were located in district health centers and run on a categorical tuberculosis basis. A public health nurse was in charge and the medical staff, for the most part, was made up of categorical tuberculosis physicians. The district clinics also were involved in screening x rays; almost 300,000 screenings were done in 1970. In 1974 96% of the tuberculosis cases were reported by hospitals and clinics; only 4% were reported by private physicians. The first change brought about was the integration of the federal grant personnel into the general citywide tuberculosis-care program. This reflected an appreciation of and need for managerial expertise and my own philosophy that one does not need an M.D.-M.P.H. degree to be a program manager. The public health advisors were given line responsibility over the entire bureau. The senior advisor was given the title of associate director, later changed to deputy director of the Bureau of Tuberculosis of the City of New York. His assistants were given the title of assistant director for regional operations and placed in regional borough offices in the city. The change immediately provided strong administrative control of all the clinics by persons of proved administrative ability. The second change was the introduction of health aides into the program. These were people from the community, some were former patients who had been treated for tuberculosis; others were addicts receiving Methadone. These persons were allowed to do the field follow-up, thus freeing public health nurses to spend more time with patients without the necessary but unsafe burden of home visits. This also freed public health nurses for other activities to be described presently. The next change to be brought about was the introduction of middleBull. N. Y. Acad. Med.
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level management persons to be responsible for running the individual chest clinics. It had been our experience that the scheduling of personnel and patients and the ordering of supplies were usually left to the nurse in charge, with some help from the physician in charge. By adding a management person, the nurse was freed to spend time conferring with the patients, and the physician in treating patients. Having a management person decreased the reliance on the central office and immediately provided a career ladder: from health aide to health-aide supervisor to clinic manager and even to assistant director. We also spent much time and effort involving the voluntary sector in the care of tuberculosis. Brookdale Hospital took over one of our district clinics and made it a responsive, successful venture. After these organizational changes were made we reviewed the situation and began to reorganize the care of patients. We first looked at the patients: Were we giving them productive and meaningful supervision? We answered this with a formal patient audit. It was done by a record management team of three nonprofessionals. They visited each clinic, went through all the patients' records, and placed the patients into one of six categories: 1) Tuberculous patients who had been and still were receiving drugs for less than two years 2) Tuberculous patients who had been and still were receiving drugs for more than two years 3) Tuberculous patients who had completed drug therapy and were still being followed 4) Tuberculous patients who had never received drug therapy 5) Contacts and reactors who were receiving drugs 6) Contacts and reactors who were not receiving drugs. After the records were sorted into these categories, the physician in charge of each of the district chest clinics carefully reviewed the charts of patients in categories 2, 3, 4, and 6. The records of those in categories 1 and 5 (tuberculosis patients who had been treated for less than two years and contacts and reactors who were receiving drugs) were returned to the active file. These patients were to be maintained on drugs and given supervision at not less than monthly intervals until a two-year course of therapy was completed by the patients and one year of preventive therapy was completed by the contacts and reactors. As a new policy the bureau issued a directive that all tuberculosis patients who had completed a 24-month Vol. 53, No. 6, July-August 1977
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course on two or more drugs with reasonable response-such as negative sputa for at least a year-should be discharged outright as cured and placed on a return visitp.r.n., governed by symptoms, instead of a routine six or 12-month follow-up as previously mandated. Similarly, those who had completed 12 months of preventive therapy with isoniazid also were discharged outright with a return visit only when necessary, dictated by symptoms. Patients in category 4 with bacteriologically negative tuberculous disease who had never been treated with drugs and who were felt to be at a high risk of reactivation were added to the active file to receive a year of isoniazid preventive therapy with monthly follow-up, and then discharged with return visits p.r.n. for symptoms. In all, no patients were to receive routine follow-up for adequately treated inactive disease unless specific, justifiable clinical circumstances existed. Actually, these circumstances sometimes dictated medical follow-up in a general medical facility rather than in the chest clinic. At the time these new procedures were instituted there was much shock and consternation among the medical and nursing staff of the New York City Department of Health. Tampering with periodic recall for the life of the tuberculous patient seemed akin to tampering with such well recognized traditions as motherhood and executive privilege. We were asked how we could discharge outpatients and how we could use the word "cure" when the word "arrested" had withstood the test of time. Actually, we were following logic and what previously had been reported in the literature. Under logic, we could point out that 1) a yearly chest x ray would only help those patients whose disease had reactivated in the two or three months prior to the recall, 2) a yearly chest x ray would keep some patients from reporting to the clinics on the basis of symptoms when they could wait until their ordained appointment, and 3) those patients who keep yearly recall appointments are likely to be those who were most cooperative with therapy originally and who we would not expect to reactivate. From the literature we could cite that 1) as Grzybowski and associates reported in 1966,1 antimicrobial treatment of active tuberculosis strikingly reduces the frequency of reactivation, 2) Horwitz, from the Danish Tuberculosis Index, in 1969 pointed out that adequately treated cases reactivate infrequently,2 and 3) the British Medical Research Council in 19693 actually suggested that patients who were bacteriologically negative at the end of 18 months of chemotherapyBull. N. Y. Acad. Med.
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whether they had residual cavitation or not-have a very low relapse rate. They went so far as to question the need for routine, long-term follow-up, and suggested concentrating resources on newly developed, bacteriologically positive cases and their contacts. More recently, Edsall and Collins in New York,4 Bailey in New Orleans,5 Stead,6 who was then in Milwaukee, and Snider7 from Oklahoma pointed out variously that: few patients who reactivated were found on routine follow-up; those who did reactivate and were found on routine follow-up most often had another factor that would dictate follow-up for a nontubercular condition; and most patients who reactivated could have been predicted because they were uncooperative with treatment, did not receive adequate treatment, or were never inactive. 4) As for follow-up of patients receiving preventive therapy, Ferebee in 19698 stated that, while isoniazid produced the greatest reduction of cases in the treatment year, there was no indication that the effect gradually disappears with time. Before the audit of March 31, 1972 the case-register report of the New York City Bureau of Tuberculosis showed 29,000 listed cases. The audit found 12,500 cases under inactive supervision. These were patients who had completed drug therapy and were scheduled for yearly recall, but on whom no effort was expended to bring them in when they failed to keep appointments. These cases were dropped from the register and eliminated from routine follow-up. In the 22 district chest clinics 16,600 remaining charts were reviewed; 7,500 in categories 2, 3, 4, and 6 were defined as receiving unnecessary and unproductive supervision according to the new standards of the bureau and were discharged from clinic care. These cases represented 44.8% of the actively supervised charts reviewed. In categories 1 and 5, 9,200 patients were retained in the active file. Twenty-five hundred cases in categories 4 and 6 were found and identified as being at high risk of developing bacteriologically positive tuberculosis; these were started on one year of isoniazid preventive therapy with monthly follow-up and discharged after one year. This all took place in 1972. More recently, the Center for Disease Control of the U.S. Department of Health, Education, and Welfare endorsed the concept of discontinuing periodic recall with a statement. The American Thoracic Society is about to release a statement which also will endorse this logical and necessary step. With the audit carried out and the patients discharged, we began to look at other activities of the Bureau of Tuberculosis. We found, for instance, Vol. 53, No. 6, July-August 1977
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that many walk-in screening x rays were done. In 1970 alone 283,000 survey x rays were done and 44 not previously registered, active cases of tuberculosis were found. This is a rate of less than 16 per 100,000 screening x rays, not a very productive exercise. We wondered who was getting x rayed and we reviewed the New York City Health Code. We found that all employees of the New York City Board of Education, all nurse-midwives, all Park Department employees, and all pregnant women were required to have the film, which was usually of 70 mm. size. With the help of a statement from the assistant secretary for health, in 1972 we amended the health code so that x rays would be done only if a medical indication existed, not for screening. The change in the Health Code mandated that tuberculin skin tests be given in place of x rays. The reasoning here is that it is now known that 92% of all cases of tuberculosis in the United States come from those previously infected, that is, those who had a positive skin test. Only 8% arise in those not infected previously. They become infected and go on to get disease. Since for all practical purposes all persons with tuberculosis will be reactors, they would still be picked up by the tuberculin skin test, with much less radiation being added to the patients' environment; also, the skin test is much cheaper than the x ray. It also was our experience that diagnostic x rays taken of a patient with a known positive tuberculin test receive a more careful reading and analysis than a routine screening film. With this background we closed all walk-in screening x ray facilities in New York City, but did make films available for persons aged 50 years or older who actually had pulmonary symptoms or were heavy smokers. We reopened walk-in tuberculin testing sites at the district clinics and at the previously functioning x-ray units. Since it was counterproductive to have nurses and doctors give and read the tuberculin tests, we used the aforementioned health aides and trained them to give the test, interpret them, and counsel the patients. People who came in for testing would have the test placed and read by a community worker; the return rate for reading has been well over 86% at the walk-in localities. If the test was positive, a roentgenogram was taken at the same return visit and the patient with his x ray would be seen by a physician for a decision as to whether he should receive isoniazid preventive therapy. If positive reaction was found and the patient was given isoniazid, he would be followed at monthly intervals, both to improve compliance and for surveillance for isoniazid-associated hepatitis. Bull. N. Y. Acad. Med.
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The next logical decision was who would follow the patient. Is it necessary to have a clinic physician see every patient on preventive therapy at monthly intervals? After discussing this with the nursing service, we jointly decided that this activity could logically be carried out by nurses. We then set up preventive therapy sessions in our district clinics; these were staffed only by a nurse who would, with the aid of a questionnaire, ask a series of questions designed to elicit symptoms of hepatotoxicity. If the patient gave any positive answers, he would immediately be referred to the physician who would, with the patient present, decide if the drug should be continued or if further work-up would be required, and he would initiate such work-up. For any uncomplicated course the physician would see the patient only at the initial conference session. At the end of the 12-month course the patient is discharged, and no terminal x ray is taken. Nurses readily accepted the program enthusiastically. It gives them an opportunity to use their clinical judgment and skill in counselling, motivating, and monitoring the patients. It also frees physicians for following the complicated cases. At the outset we spoke of inpatient management being necessary only for sick patients, but many tuberculous patients are recalcitrant and have many problems, especially those who are alcoholics and drug addicts. (Short-course chemotherapy and intermittent therapy will be discussed by other speakers at this symposium.) With nurses caring for preventive therapy patients, the next question that arises is why not have the physician see only the complicated, drug-resistant cases and let the nurse do the routine monthly follow-up of uncomplicated cases, checking on compliance and drug toxicity. This arrangement also would let the physician handle the varied, nontuberculosis medical problems of all tuberculous patients. If nurses can handle these problems in the public sector, then primary-care physicians can certainly handle these problems in the private sector and must be encouraged to do so. We have discussed a number of new programs; the next obvious consideration is who is going to pay for them. Earlier we stated that federal and local money was used, but how can we fund new activities for a problem which universally is considered unpopular? The answer for the public sector is simple. If most of the newer, proved aspects of controlling tuberculosis are adopted, the savings generated in the program itself will more than pay for the surveillance of patients with drug toxicity, increased tuberculosis screening, and newer patient-oriented means of follow-up. Vol. 53, No. 6, July-August 1977
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The City of New York estimated that it saved almost $300,000 each year by discharging and not formally following its adequately treated patients. The state of New Jersey was told by a recent task force that it could close its state tuberculosis sanatorium, which cost $3.3 million a year, and fund its increased outpatient activities more efficiently with follow-up for $900,000. The state of Connecticut was recently told by a study group that if it discharged all the patients on its case register-most of whom were inactive-and started a new register with the newly reported cases, it could save close to $200,000 in administrative costs of running the register. At last count its register contained 9,494 names and the state has only 278 new cases yearly. Revaluation of the tuberculosis programs nationally still indicates that considerable unnecessary expenditures in the control of tuberculosis accrue in the United States today and that a reconsideration of priorities in this field will be rewarding. Discharging adequately treated tuberculous patients from follow-up, a year of preventive therapy rather than lifelong recall of old calcific infiltrates who never were treated adequately, comprehensive pulmonary-disease clinics in place of categorical tuberculosis clinics, closure of state sanatoria, with movement of tuberculosis patients to comprehensive outpatient follow-up facilities and general hospitals when necessary, nurse-directed clinics, substitution of tuberculin testing for mass or walk-in radiologic screening facilities-these all are surprisingly productive as high-priority programs. They will make tuberculosis itself more relevant and responsive to 1976 and more self-supporting, with only minor dependence on outside resources. With the movement of the care of tuberculosis to the mainstream of medicine and medical care, the private sector will be getting more involved in this common but not special medical problem. The health agency will continue to serve as a reporting and resource center, but gradually will get out of the health-care delivery business, at least in tuberculosis. Tuberculosis is one major public-health problem for which the newer and better state of the art is clearly the cheaper one. REFERENCES 1.
Grzybowski, S., McKinnon, N. E., Tuders, L., et al.: Reactivations in inactive pulmonary tuberculosis. Am.
Rev. Respir. Dis. 93:352, 1966. 2. Horwitz, 0.: Public health aspects of
3.
relapsing tuberculosis. Am. Rev. Respir. Dis. 99: 182, 1969. East African/British Medical Research Council: The results from 12 to 36 months in patients submitted to two
Bull. N. Y. Acad. Med.
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studies of primary chemotherapy for pulmonary tuberculosis in East Africa. Tubercle 50:233, 1969. 4. Edsall, J. and Collins, G.: Routine followup of inactive tuberculosis. A practice to be abandoned. Am. Rev. Respir. Dis. 107:851-53, 1973. 5. Bailey, W. C., Thompson, D. H., Jacobs, S., et al.: Evaluating the need for periodic recall and re-examination of patients with inactive pulmonary tuberculosis. Am. Rev. Respir. Dis. 107:854-57, 1973.
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Stead, W. W. and Jurgens, G. H.: Productivity of prolonged followup after therapy for tuberculosis. Am. Rev. Respir. Dis. 108:314-20, 1973. 7. Snider, D.: Reactivation of tuberculosis in Oklahoma, 1970-1973. Chest 68:36, 1975. 8. Ferebee, S. H.: Controlled chemoprophylaxis trials in tuberculosis: A general review. Adv. Tuberc. 17:28-106, 1970. 6.
NEW CHALLENGES IN AMBULATORY CARE OF TUBERCULOSIS* LEE B. REICHMAN, M.D., M.P.H.t Associate Professor of Medicine New Jersey Medical School Chief, Pulmonary Division Martland Hospital Newark, N.J.
ONE way to look at tuberculosis is as a prism through which the deficiencies in health-care delivery can be viewed. It is the only disease in the nation's top causes of death that medical science now has the wherewithal to handle. Much of the basic research has been done. The transmission and pathogenesis are understood. The treatment can be successful in almost all patients who take their drugs faithfully. The national case rate, however, is still about 14 per 100,000 population and there are still close to 3,800 deaths due to tuberculosis. The national figures give a false sense of security. If we look into the inner-city ghetto populations we still find incredible rates for this day and age. These data would be even more alarming if we did not have access to information about previous years like 1960 when the rate in Central Harlem was 252 cases per 100,000 population. The rate for New York City as a whole in 1940, long before isoniazid was discovered, was 130 per 100,000, or about equal to the 1971 rate in Harlem. That such populations retain a very high case rate of tuberculosis in 1975 suggests that we must be experiencing deficiencies in the delivery of health care to tuberculous patients. I shall suggest briefly what the problem is and what can be done about it. It is hoped that these remarks will be refreshing, because the solution is no more expensive than what we are now doing. First we must make some basic assumptions. These are based on good evidence and faith. We may hope they will lead us to the workable solutions which we need in the problems of delivering care to tuberculous outpatients. *Presented as part of a Symposium on Selected Aspects of Pulmonary Disease held by the Section on Medicine of the New York Academy of Medicine March 3, 1976. tSupported by Pulmonary Academic Award No. 5 K07 HL 00124-02 from the National Heart, Lung, and Blood Institute, Bethesda, Md. Address for reprint requests: Mardand Hospital, 65 Bergen Street, Newark, N.J. 07107.
Bull. N. Y. Acad. Med.
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The first assumption we must make is that almost all tuberculosis can be treated on an outpatient basis if a suitable interest in delivering care and motivating patients exists. A corollary is that the only indication for hospitalization for tuberculosis is illness in the patient. Another corollary that I have come across in heading the recent Task Force to Consider the Future of the New Jersey State Hospital for Chest Diseases-we recommended its closure, which occurred last year-is that the existence of a state facility (read "sanatorium" or "dumping ground") which permits tuberculosis care and control to be taken out of the mainstream of medical care can militate against the development of a viable system for delivering tuberculosis health care in both the public and private sectors of medicine. If all acutely ill patients are sent to the sanatorium, there is no need for private physicians to become adept at the treatment of this disease and to face their responsibility to participate meaningfully in the management of tuberculosis, with the use of general hospitals when necessary. One other assumption, obvious to those who care for tuberculosis patients, is that some patients are more concerned with the other problems of their lives than with their tuberculosis. Many are alcoholics or drug addicts. They are poor people who have difficulty finding homes, getting work, or keeping their families together. Their tuberculosis certainly is not of as much concern to them as their other personal problems. The delivery system for tuberculosis care must take this factor into account and must meet it along with the other deficiencies in tuberculosis care. The outpatient system must conform to the patient and not vice versa. There are many opportunities for innovation in delivering this care. Categorical outpatient care systems which are updated are expensive. As morbidity and mortality from this disease decrease its importance as a national health problem diminishes. Practical and political considerations divert national, state, and local jurisdictional funding of health programs to more newsworthy priorities. Voluntary tuberculosis associations are now lung associations. Federal project grants specifically for tuberculosis programs have been discontinued and jurisdictions now use local funds or vie for federal block grant funds to the exclusion of other programs. We have found, however, that we really might not need outside help. Such aid may be counterproductive. It is far more important to redesign priorities within tuberculosis-control programs now to make them self-sufficient. To introduce some of these concepts leading to new priorities I shall describe the programs I carried out when I was with the New York City Vol. 53, No. 6, July-August 1977
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Department of Health from 1971 to 1973. These were all done without the infusion of new funds. In 1971 at the New York City Department of Health the problem had already been defined by an earlier task-force report. There were still 2,500 new active cases and 400 deaths. There were 30 clinics divided into two types. Eight of these were located in hospitals and supported directly under project grant funds from the federal government. These were "combined clinics" reflecting combined input from the New York City Department of Health, The Health and Hospitals Corporation, and a federal project grant. Each clinic had a clinic manager and was staffed medically by internists and house staff. They were administered by U. S. Public Health Service advisors who were separated from the Bureau of Tuberculosis and had their own office and staff. The 22 "have-not" clinics were located in district health centers and run on a categorical tuberculosis basis. A public health nurse was in charge and the medical staff, for the most part, was made up of categorical tuberculosis physicians. The district clinics also were involved in screening x rays; almost 300,000 screenings were done in 1970. In 1974 96% of the tuberculosis cases were reported by hospitals and clinics; only 4% were reported by private physicians. The first change brought about was the integration of the federal grant personnel into the general citywide tuberculosis-care program. This reflected an appreciation of and need for managerial expertise and my own philosophy that one does not need an M.D.-M.P.H. degree to be a program manager. The public health advisors were given line responsibility over the entire bureau. The senior advisor was given the title of associate director, later changed to deputy director of the Bureau of Tuberculosis of the City of New York. His assistants were given the title of assistant director for regional operations and placed in regional borough offices in the city. The change immediately provided strong administrative control of all the clinics by persons of proved administrative ability. The second change was the introduction of health aides into the program. These were people from the community, some were former patients who had been treated for tuberculosis; others were addicts receiving Methadone. These persons were allowed to do the field follow-up, thus freeing public health nurses to spend more time with patients without the necessary but unsafe burden of home visits. This also freed public health nurses for other activities to be described presently. The next change to be brought about was the introduction of middleBull. N. Y. Acad. Med.
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level management persons to be responsible for running the individual chest clinics. It had been our experience that the scheduling of personnel and patients and the ordering of supplies were usually left to the nurse in charge, with some help from the physician in charge. By adding a management person, the nurse was freed to spend time conferring with the patients, and the physician in treating patients. Having a management person decreased the reliance on the central office and immediately provided a career ladder: from health aide to health-aide supervisor to clinic manager and even to assistant director. We also spent much time and effort involving the voluntary sector in the care of tuberculosis. Brookdale Hospital took over one of our district clinics and made it a responsive, successful venture. After these organizational changes were made we reviewed the situation and began to reorganize the care of patients. We first looked at the patients: Were we giving them productive and meaningful supervision? We answered this with a formal patient audit. It was done by a record management team of three nonprofessionals. They visited each clinic, went through all the patients' records, and placed the patients into one of six categories: 1) Tuberculous patients who had been and still were receiving drugs for less than two years 2) Tuberculous patients who had been and still were receiving drugs for more than two years 3) Tuberculous patients who had completed drug therapy and were still being followed 4) Tuberculous patients who had never received drug therapy 5) Contacts and reactors who were receiving drugs 6) Contacts and reactors who were not receiving drugs. After the records were sorted into these categories, the physician in charge of each of the district chest clinics carefully reviewed the charts of patients in categories 2, 3, 4, and 6. The records of those in categories 1 and 5 (tuberculosis patients who had been treated for less than two years and contacts and reactors who were receiving drugs) were returned to the active file. These patients were to be maintained on drugs and given supervision at not less than monthly intervals until a two-year course of therapy was completed by the patients and one year of preventive therapy was completed by the contacts and reactors. As a new policy the bureau issued a directive that all tuberculosis patients who had completed a 24-month Vol. 53, No. 6, July-August 1977
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course on two or more drugs with reasonable response-such as negative sputa for at least a year-should be discharged outright as cured and placed on a return visitp.r.n., governed by symptoms, instead of a routine six or 12-month follow-up as previously mandated. Similarly, those who had completed 12 months of preventive therapy with isoniazid also were discharged outright with a return visit only when necessary, dictated by symptoms. Patients in category 4 with bacteriologically negative tuberculous disease who had never been treated with drugs and who were felt to be at a high risk of reactivation were added to the active file to receive a year of isoniazid preventive therapy with monthly follow-up, and then discharged with return visits p.r.n. for symptoms. In all, no patients were to receive routine follow-up for adequately treated inactive disease unless specific, justifiable clinical circumstances existed. Actually, these circumstances sometimes dictated medical follow-up in a general medical facility rather than in the chest clinic. At the time these new procedures were instituted there was much shock and consternation among the medical and nursing staff of the New York City Department of Health. Tampering with periodic recall for the life of the tuberculous patient seemed akin to tampering with such well recognized traditions as motherhood and executive privilege. We were asked how we could discharge outpatients and how we could use the word "cure" when the word "arrested" had withstood the test of time. Actually, we were following logic and what previously had been reported in the literature. Under logic, we could point out that 1) a yearly chest x ray would only help those patients whose disease had reactivated in the two or three months prior to the recall, 2) a yearly chest x ray would keep some patients from reporting to the clinics on the basis of symptoms when they could wait until their ordained appointment, and 3) those patients who keep yearly recall appointments are likely to be those who were most cooperative with therapy originally and who we would not expect to reactivate. From the literature we could cite that 1) as Grzybowski and associates reported in 1966,1 antimicrobial treatment of active tuberculosis strikingly reduces the frequency of reactivation, 2) Horwitz, from the Danish Tuberculosis Index, in 1969 pointed out that adequately treated cases reactivate infrequently,2 and 3) the British Medical Research Council in 19693 actually suggested that patients who were bacteriologically negative at the end of 18 months of chemotherapyBull. N. Y. Acad. Med.
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whether they had residual cavitation or not-have a very low relapse rate. They went so far as to question the need for routine, long-term follow-up, and suggested concentrating resources on newly developed, bacteriologically positive cases and their contacts. More recently, Edsall and Collins in New York,4 Bailey in New Orleans,5 Stead,6 who was then in Milwaukee, and Snider7 from Oklahoma pointed out variously that: few patients who reactivated were found on routine follow-up; those who did reactivate and were found on routine follow-up most often had another factor that would dictate follow-up for a nontubercular condition; and most patients who reactivated could have been predicted because they were uncooperative with treatment, did not receive adequate treatment, or were never inactive. 4) As for follow-up of patients receiving preventive therapy, Ferebee in 19698 stated that, while isoniazid produced the greatest reduction of cases in the treatment year, there was no indication that the effect gradually disappears with time. Before the audit of March 31, 1972 the case-register report of the New York City Bureau of Tuberculosis showed 29,000 listed cases. The audit found 12,500 cases under inactive supervision. These were patients who had completed drug therapy and were scheduled for yearly recall, but on whom no effort was expended to bring them in when they failed to keep appointments. These cases were dropped from the register and eliminated from routine follow-up. In the 22 district chest clinics 16,600 remaining charts were reviewed; 7,500 in categories 2, 3, 4, and 6 were defined as receiving unnecessary and unproductive supervision according to the new standards of the bureau and were discharged from clinic care. These cases represented 44.8% of the actively supervised charts reviewed. In categories 1 and 5, 9,200 patients were retained in the active file. Twenty-five hundred cases in categories 4 and 6 were found and identified as being at high risk of developing bacteriologically positive tuberculosis; these were started on one year of isoniazid preventive therapy with monthly follow-up and discharged after one year. This all took place in 1972. More recently, the Center for Disease Control of the U.S. Department of Health, Education, and Welfare endorsed the concept of discontinuing periodic recall with a statement. The American Thoracic Society is about to release a statement which also will endorse this logical and necessary step. With the audit carried out and the patients discharged, we began to look at other activities of the Bureau of Tuberculosis. We found, for instance, Vol. 53, No. 6, July-August 1977
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that many walk-in screening x rays were done. In 1970 alone 283,000 survey x rays were done and 44 not previously registered, active cases of tuberculosis were found. This is a rate of less than 16 per 100,000 screening x rays, not a very productive exercise. We wondered who was getting x rayed and we reviewed the New York City Health Code. We found that all employees of the New York City Board of Education, all nurse-midwives, all Park Department employees, and all pregnant women were required to have the film, which was usually of 70 mm. size. With the help of a statement from the assistant secretary for health, in 1972 we amended the health code so that x rays would be done only if a medical indication existed, not for screening. The change in the Health Code mandated that tuberculin skin tests be given in place of x rays. The reasoning here is that it is now known that 92% of all cases of tuberculosis in the United States come from those previously infected, that is, those who had a positive skin test. Only 8% arise in those not infected previously. They become infected and go on to get disease. Since for all practical purposes all persons with tuberculosis will be reactors, they would still be picked up by the tuberculin skin test, with much less radiation being added to the patients' environment; also, the skin test is much cheaper than the x ray. It also was our experience that diagnostic x rays taken of a patient with a known positive tuberculin test receive a more careful reading and analysis than a routine screening film. With this background we closed all walk-in screening x ray facilities in New York City, but did make films available for persons aged 50 years or older who actually had pulmonary symptoms or were heavy smokers. We reopened walk-in tuberculin testing sites at the district clinics and at the previously functioning x-ray units. Since it was counterproductive to have nurses and doctors give and read the tuberculin tests, we used the aforementioned health aides and trained them to give the test, interpret them, and counsel the patients. People who came in for testing would have the test placed and read by a community worker; the return rate for reading has been well over 86% at the walk-in localities. If the test was positive, a roentgenogram was taken at the same return visit and the patient with his x ray would be seen by a physician for a decision as to whether he should receive isoniazid preventive therapy. If positive reaction was found and the patient was given isoniazid, he would be followed at monthly intervals, both to improve compliance and for surveillance for isoniazid-associated hepatitis. Bull. N. Y. Acad. Med.
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The next logical decision was who would follow the patient. Is it necessary to have a clinic physician see every patient on preventive therapy at monthly intervals? After discussing this with the nursing service, we jointly decided that this activity could logically be carried out by nurses. We then set up preventive therapy sessions in our district clinics; these were staffed only by a nurse who would, with the aid of a questionnaire, ask a series of questions designed to elicit symptoms of hepatotoxicity. If the patient gave any positive answers, he would immediately be referred to the physician who would, with the patient present, decide if the drug should be continued or if further work-up would be required, and he would initiate such work-up. For any uncomplicated course the physician would see the patient only at the initial conference session. At the end of the 12-month course the patient is discharged, and no terminal x ray is taken. Nurses readily accepted the program enthusiastically. It gives them an opportunity to use their clinical judgment and skill in counselling, motivating, and monitoring the patients. It also frees physicians for following the complicated cases. At the outset we spoke of inpatient management being necessary only for sick patients, but many tuberculous patients are recalcitrant and have many problems, especially those who are alcoholics and drug addicts. (Short-course chemotherapy and intermittent therapy will be discussed by other speakers at this symposium.) With nurses caring for preventive therapy patients, the next question that arises is why not have the physician see only the complicated, drug-resistant cases and let the nurse do the routine monthly follow-up of uncomplicated cases, checking on compliance and drug toxicity. This arrangement also would let the physician handle the varied, nontuberculosis medical problems of all tuberculous patients. If nurses can handle these problems in the public sector, then primary-care physicians can certainly handle these problems in the private sector and must be encouraged to do so. We have discussed a number of new programs; the next obvious consideration is who is going to pay for them. Earlier we stated that federal and local money was used, but how can we fund new activities for a problem which universally is considered unpopular? The answer for the public sector is simple. If most of the newer, proved aspects of controlling tuberculosis are adopted, the savings generated in the program itself will more than pay for the surveillance of patients with drug toxicity, increased tuberculosis screening, and newer patient-oriented means of follow-up. Vol. 53, No. 6, July-August 1977
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The City of New York estimated that it saved almost $300,000 each year by discharging and not formally following its adequately treated patients. The state of New Jersey was told by a recent task force that it could close its state tuberculosis sanatorium, which cost $3.3 million a year, and fund its increased outpatient activities more efficiently with follow-up for $900,000. The state of Connecticut was recently told by a study group that if it discharged all the patients on its case register-most of whom were inactive-and started a new register with the newly reported cases, it could save close to $200,000 in administrative costs of running the register. At last count its register contained 9,494 names and the state has only 278 new cases yearly. Revaluation of the tuberculosis programs nationally still indicates that considerable unnecessary expenditures in the control of tuberculosis accrue in the United States today and that a reconsideration of priorities in this field will be rewarding. Discharging adequately treated tuberculous patients from follow-up, a year of preventive therapy rather than lifelong recall of old calcific infiltrates who never were treated adequately, comprehensive pulmonary-disease clinics in place of categorical tuberculosis clinics, closure of state sanatoria, with movement of tuberculosis patients to comprehensive outpatient follow-up facilities and general hospitals when necessary, nurse-directed clinics, substitution of tuberculin testing for mass or walk-in radiologic screening facilities-these all are surprisingly productive as high-priority programs. They will make tuberculosis itself more relevant and responsive to 1976 and more self-supporting, with only minor dependence on outside resources. With the movement of the care of tuberculosis to the mainstream of medicine and medical care, the private sector will be getting more involved in this common but not special medical problem. The health agency will continue to serve as a reporting and resource center, but gradually will get out of the health-care delivery business, at least in tuberculosis. Tuberculosis is one major public-health problem for which the newer and better state of the art is clearly the cheaper one. REFERENCES 1.
Grzybowski, S., McKinnon, N. E., Tuders, L., et al.: Reactivations in inactive pulmonary tuberculosis. Am.
Rev. Respir. Dis. 93:352, 1966. 2. Horwitz, 0.: Public health aspects of
3.
relapsing tuberculosis. Am. Rev. Respir. Dis. 99: 182, 1969. East African/British Medical Research Council: The results from 12 to 36 months in patients submitted to two
Bull. N. Y. Acad. Med.
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studies of primary chemotherapy for pulmonary tuberculosis in East Africa. Tubercle 50:233, 1969. 4. Edsall, J. and Collins, G.: Routine followup of inactive tuberculosis. A practice to be abandoned. Am. Rev. Respir. Dis. 107:851-53, 1973. 5. Bailey, W. C., Thompson, D. H., Jacobs, S., et al.: Evaluating the need for periodic recall and re-examination of patients with inactive pulmonary tuberculosis. Am. Rev. Respir. Dis. 107:854-57, 1973.
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Stead, W. W. and Jurgens, G. H.: Productivity of prolonged followup after therapy for tuberculosis. Am. Rev. Respir. Dis. 108:314-20, 1973. 7. Snider, D.: Reactivation of tuberculosis in Oklahoma, 1970-1973. Chest 68:36, 1975. 8. Ferebee, S. H.: Controlled chemoprophylaxis trials in tuberculosis: A general review. Adv. Tuberc. 17:28-106, 1970. 6.
