NEW YORK STATE DEPARTMENT OF HEALTH, BUREAU OF EPIDEMIOLOGY AND COMMUNICABLE DISEASE CONTROL, Supplement to MP CD 53: 701. August 7, 1953. To: Regional health officers, district State health officers, city and county health commissioners. From: Dr. Korns. Subject: Use and distribution of gamma globulin for the prophylaxis of poliomyelitis, measles, hepatitis, and rubelle. Poliomyelitis Supplementing paragraph 4b on page 3, use of gamma globulin for nurses will be limited to those under 30 years of age who have had direct personal contact with poliomyelitis patients in the communicable stage of the disease. Paragraph 5, page 4, is amended to describe the authorization number in terms of cubic centimeters of gamma globulin allocated instead of number of vials. Paragraph 7 of the same page is amended to indicate that most of the basic allocation of poliomyelitis gamma globulin is packaged in 2 cubic centimeters ampules. Similarly, the gamma globulin used for measles, German measles, and hepatitis is packaged in 2 cubic centimeters ampules. Paragraph 9, page 5, should be expanded to call attention to the poliomyelitis study plan outlined in a separate memorandum using the modified form CD 316 to be completed for each case of poliomyelitis with onset after June 1, 1953. Current cases are to be investigated at some time between 2 and 4 weeks after the onset of symptoms. Form CD 318 for cases of poliomyelitis is to be filled out in duplicate, one copy retained in the issuing office to assist in the preparation of form CD 316, the other copy to be sent immediately after completion to the Bureau of Epidemiology and Communicable Disease Control. Infectious hepatitis Statement on page 7 should be modified to request completion of form CD 318 in duplicate in connection with the allocation of gamma globulin to the contacts of cases of infectious hepatitis, one copy to be retained in the issuing office for use in completion of form CD 144A, the other copy to be sent immediately after completion to the Bureau of Epidemiology and Communicable Disease Control. The outline of the study designed to evaluate the use of gamma globulin in household contacts of cases of infectious hepatitis is presented in a separate memorandum, Form CD 144, entitled "Homologous Serum Jaundice, Supplemental Report,' remains unchanged and should continue to be completed for reported cases of serum hepatitis. Endorsed: Memorandum. R. F. K. V. A. VAN VOLKENBURGH, M. D. AUGUST 7, 1953. To: Regional health directors, county health commissioners, district health officers, and city health officers. From: Dr. Korns, C. D. Bureau. Subject: Comment on poliomyelitis gamma globulin distribution plan. The plan for gamma globulin distribution in the prophylaxis of poliomyelitis which became effective May 15, despite some difficulties, has functioned remarkably well thus far in most parts of the State. It is not proposed to change it at this time, however, attention should be called to the exact wording of one portion of the plan as it was distributed to all physicians in the State. In the paragraph concerning nonhousehold contacts the following statement appears "within the 60 cubic centimeters average allotment per case, the health officer may provide gamma globulin for administration to persons not members of the patient's household." Since great difficulties have arisen in certain areas, particularly the metropolitan counties, concerning the definition of nonhousehold contacts and the decision as to how many of those so labeled deserve gamma globulin, it is deemed wise to make clear that the allocation of gamma globulin for use in nonhousehold contacts is a permissive matter and that the county, city, or district health officer administering the program has the authority to limits its distribution. Thus, certain counties have found it necessary to categorically exclude nonhousehold contacts from the program. It would seem, however, that before adopting such a rigid rule the health officer should assure himself that the program being carried out in his area is making use of a large portion or the entire amount of 60 milliliters per reported case. In this connection, it is interesting to review the information available in this office on how health officers have been allocating gamma globulin to date. Actually, from the forms CD 318 available here (135) an average of only 41 milliliters gamma globulin has been used per case, 32 milliliters for household contacts, and 9 milliliters for nonhousehold contacts. This, of course, may not be a fair sample of the entire State's experience. One additional point of interest with direct bearing on the value of the program is the observation that 75 percent of the contacts given gamma globulin received it within 5 days after the onset of the index case. Approximately one-third of the basic allocation of 158,280 milliliters gamma globulin to New York State has been distributed to supply stations. It will be recalled that the national plan contemplated issuing supplemental allocations of gamma globulin to the States at biweekly intervals starting July 1, and consisting of 60 milliliters for each reported case in excess of the 5-year average 1947-51. Since, as of the present time, New York State has had reported over four times as much poliomyelitis this year as the average of this 5-year experience, we are due for a sizable supplemental allocation. Inquiry at Washington, however, indicates that the national supply is exhausted at the moment and that supplemental allocations may not be issued until mid-September. The problem is one of slowness in processing gamma globulin for distribution. The original goal of 7 million milliliters or 1 million doses may be achieved by the end of the year, but much of this may not be available until the end of the poliomyelitis season. Despite this fact, however, it does not seem necessary to change the program in New York State and we probably will not run out of material before supplemental supplies become available. Another issue raised by several health officers concerns the allocation of inaterial by one health officer for individuals who are residents of other counties or other States. In the metropolitan areas, around New York City, this same question applies to the many New York City residents who are exposed to poliomyelitis in upstate areas. The health officers concerned have always expressed hesitancy in allocating gamma globulin for use in such individuals, be they household or nonhousehold contacts, since it was their impression that predetermined amounts of gamma globulin were being parceled out to each county based on past poliomyelitis experience, and that when this supply was exhausted the particular county would receive no more. Actually, in practice, the entire State, including New York City is considered as a unit and gamma globulin is distributed to supply stations as the need develops and is expressed by the local area. It is our belief that all the allocating health officers are closely following the basic plan and, therefore, the gamma globulin distributed is being properly utilized. Thus, the only concern the allocating health officer need have is to establish to his satisfaction that the index case is a bona fide case of poliomyelitis and that the contacts involved meet the specifications of the plan. In other words, the health officer in whose jurisdiction the case of poliomyelitis occurs should be the one primarily involved in allocating gamma globulin. This will help to avoid the dilemma where several health officers allocate for the contacts of a single case, thus, in combination, distributing far more than the average of 60 milliliters. There are, of course, other problems associated with bookkeeping and exchange between adjacent health departments which can best be settled at the local level as they arise. One other feature of the program needs additional comment. The plan allows for the giving of gamma globulin to nurses who are in direct physical contact with a case during the communicable stage and as presently worded does not define an upper-age limitation. It has been decided to limit this arbitrarily to nurses under 30 years of age, in keeping with the limitation applied to household contacts. This seems eminently justified because of the low attack rate in older age groups. It should be mentioned that in certain areas, particularly New York City, it has been found necessary to exclude nurses entirely as recipients of gamma globulin, since it was felt that giving it to a few nurses would necessitate giving it to thousands which would easily dissipate the entire supply of gamma globulin for a small benefit. The only other point that needs to be mentioned at this time concern the completion of the form CD 316 which has been revised and is distributed with a separate memorandum discussing the evaluation studies of gamma globulin prophylaxis in poliomyelitis and hepatitis. Memorandum NEW YORK STATE DEPARTMENT OF HEALTH, To: Regional health directors, county and city health commissioners, and district State health officers. From: Dr. Korns. Subject: Field studies to evaluate the effectiveness of gamma globulin in the control of poliomyelitis and infectious hepatitis. Poliomyelitis A. Study of households with more than one case of poliomyelitis.-In the search for a technique to evaluate the prophylactic effectiveness of gamma globulin administered to household contacts of index poliomyelitis cases, a committee of nationally recognized authorities met in Atlanta last spring under the sponsorship of the United States Public Health Service. One of the suggested study plans, aimed at determining the secondary attack rate from poliomyelitis in families of index cases receiving gamma globulin as compared to families not receiving gamma globulin, was discarded as impossible to achieve satisfactorily. It was estimated that a sample of 15,000 index cases with some 40,000 household contacts would be needed to demonstrate a statistically significant effect on the secondary attack rate, and that even though such a large sample were studied it would be hazardous to compare this experience with the secondary attack rate in previous years in other areas. For that matter, the comparison of such rates with those in families with a 1953 index case, but not receiving gamma globulin, would be subject to error since the two groups of families would not be comparable. Furthermore it was assumed that there would be relatively few families this summer in which a case occurred where gamma globulin was not administered to household contacts. Thus a second approach to evaluation, aimed at measuring modification rather than prevention was devised and constitutes the study plan presented here. This involves the comparison of the extent of paralysis in cases of poliomyelitis occurring in multiple-case households. Those patients coming down with their illness during the period between the onset of the index case and the date of gamma globulin administration, and referred to as group I, would be compared with those patients developing symptoms during the week following administration of gamma globulin (group II). If the program were successful, an appreciable diminution in the extent of paralysis might be demonstrated in group II as compared to group I. The evidence available to the committee suggested that under normal circumstances without gamma globulin multiple cases in families, occurring at various intervals after the onset of the index case, did not differ particularly in average severity. This is still a weak point in the proposed study and will need to be assessed further in the final analysis. The Communicable Disease Center of the United States Public Health Service, acting upon the recommendation of this committee, has devised a study along these lines to include all multiple case families discovered in the United States this year. An initial investigation of these families will be carried out by epidemiologists assigned to the various State health departments from the Communicable Disease Center. These visits are to be scheduled during the period 7 to 14 days after onset of the index case, and are for the purpose of verifying the diagnoses and obtaining exact information concerning dates of onset and dates of gamma globulin administration, if any was given. Subsequent secondary cases discovered through the case reporting mechanism would be reviewed in similar manner. At an interval of 50 to 70 days after onset of each case a physical therapist will examine all patients in these families in a uniform fashion so as to obtain an accurate measurement of the extent of residual paralysis. Three State employed physical therapists participated several weeks ago in a course sponsored by the United States Public Health Service, at Pittsburgh, devoted to the indoctrination of these muscle graders in a uniform and simplified technique. One may criticize the design of the study, but it is perhaps the best possible under the circumstances. The above study makes no demands on the time of other State or local health department personnel. The only responsibility which falls on the shoulders of county, city, and district health officer is the discovery of multiple-case families. These, of course, will come automatically to his attention through case reports or requests for gamma globulin, and will be passed on in due time to the Bureau of Epidemiology and Communicable Disease Control. There may, however, be a considerable delay in receiving this information in Albany and it will be appreciated if the health officers concerned will notify this Bureau by memorandum of such instances, giving details as to names of patients, exact home address, and name and address of the hospital in order to expedite the investigation by the epidemiologist. These need not necessarily be individuals with the same name since persons living at the same address may bear different names. We leave to the ingenuity of each health officer the job of devising a system to discover multiple-case families among the reports sent through his office. Since, in the New York State experience, about 70 percent of the so-called secondary cases (perhaps they should be called coprimary cases) occur within the first week after the onset of the index case, the bulk of these multiple-case families will be evident at the time the physician requests gamma globulin. In this study we are referring only to clinical cases of poliomyelitis which the attending physician deems it proper to report. We are not referring to the great multitude of minor illnesses in families with an index case, which may or may not be due to infection with the polimyelitis virus, and which the physician would ordinarily not report as poliomyelitis. In summary, therefore, the only responsibility that city, county, and district health officers need play in this study is to keep informed of multiple-case families and notify this Bureau expeditiously. Earlier it was estimated that there would be not over 75 such multiple-case families in New York State and that there would be about 1,500 in the entire country. Thus far, in the SteubenChemung County focus, a total of 16 multiple-case families have been uncovered and investigated along these lines. Dr. Ernest Kane, epidemic intelligence officer from the Communicable Disease Center, assigned to this bureau, will be carrying on these studies and will keep in touch with the health officers concerned. B. Routine investigation of all reported cases of poliomyelitis with form CD 316.—The advisory committee meeting in Atlanta discussed the possibility of promoting additional joint studies in poliomyelitis involving the participation of a number of States, allowing the accumulation of information on a larger number of cases and household members. Since many State health departments routinely visit each case of poliomyelitis and obtain certain basic clinical and epidemiological information, the development of a uniform questionnaire to be used widely was deemed to be feasible and worthwhile. It is our understanding that at least 12 of the larger States are participating in this project. The revised form CD 316, a copy of which is attached with the instruction sheet for the investigator, is an abbreviated and simplified version of the form suggested by the Federal group. The primary points under investigation include the role of genetic factors, menstruation, and pregnancy in susceptibility to poliomyelitis. In addition, several other more fully established accessory factors, such as tonsillectomy, dental extraction, parenteral injections, etc., are also included. The form is devised so that the public health nurse may readily complete it. It is requested that this be done sometime during the period 2 to 4 weeks after onset of the index case. The instruction sheet which should be made available to each investigating nurse, discusses the purpose and method of answering all items about which there may be questions. These forms have already been completed on all 138 cases of poliomyelitis in Steuben and Chemung Counties and do not seem to represent an undue burden or a difficult procedure. We appreciate that since June 1, some 258 cases throughout upstate New York, exclusive of Steuben and Chemung Counties, have had onset; however, only 101 of these had onset over 1 month ago and thus represent the actual backlog, which should not place a major burden on any one area. The delay in issuing the new form CD 316, was brought about by difficulties concerned with the development of the national plan. Certain health officers have made some use of the old form CD 316 and we would appreciate their starting anew with the revised form. Infectious hepatitis Although the effectiveness of gamma globulin in preventing infectious hepatitis has been clearly demonstrated in the controlled studies within schools and institutions, the value of this material in preventing secondary cases in households has yet to be demonstrated. True enough, our administrative program is centered around use of gamma globulin in household contacts of index cases. and the decision to allocate it in this manner was made after careful thought and with the advice of national authorities. However, it is very important that the value of this program be assessed so that we may know at the end of the year, or by next year, whether this technique is accomplishing any good in terms of preventing infectious hepatitis or whether some other approach to control is preferable, (e. g. the mass use of gamma globulin in school populations when the disease appears). The evaluation of this effect is attempted through the completion of the form CD 144A, a copy of which is attached with the instruction sheet. It is requested that this form be completed for all reported cases of infectious hepatitis with onset after June 1, when gamma globulin became available for prophylaxis. The hope is that in only a portion of the reported cases will the household associates have received gamma globulin, and it will then be possible to compare the secondary attack rate in families receiving this product with those families where it was not administered. In order to study properly the comparability of families in each of these two groups, a number of other questions are inserted in the form which may at first seem irrelevant, particularly those on the environmental sanitation and structure of the dwelling unit, as well as whether the household member is a veteran or not. The investigation is to be completed 6 weeks after the onset of the index case. The reason for delay until this period is to allow time for the development of the great majority of secondary cases. Review of upstate New York experience in recent years indicates that 87 percent of the so-called secondary cases occur within 6 weeks after onset of the index case. Delay in visiting the family until then may cause loss of detail and accuracy in certain questions but, on the other hand, some of these details may be obtained from the form CD 318 completed at the time gamma globulin was allocated, or from the initial case report card. Cases of infectious hepatitis occurring in institutional populations such as State hospitals or, for that matter, any situation that does not represent the experience of hepatitis in a household, need not be investigated in this manner since, obviously, such cases would not assist in answering the question proposed. A review of the cases in your area with onset since June 1 and more than 6 weeks ago, will reassure you that the number of investigations to be completed immediately is not large. It is contemplated that the public health nurse will be the primary investigator. Another reassuring thought to the health officer, who feels that this request to participate in this investigation is an imposition at this time, is the knowledge that infectious hepatitis customarily follows a seasonal pattern quite different from poliomyelitis, having a peak in the spring and late fall but a low point during the summer. INVESTIGATOR'S INSTRUCTIONS FOR COMPLETING CD 316 R. F. K. This investigation is part of a larger study of similar nature being conducted in many other States this summer under the sponsorship of the United States Public Health Service. The findings in New York State will be made part of the total study. The form is to be completed for all cases of poliomyelitis with onset since June 1, 1953. On current cases it is suggested that the form be completed sometime between 2 and 4 weeks after the onset of the index case. Date of onset.-Defined as the date of onset of any contagious illness leading to the signs and symptoms of central nervous system involvement which is subsequently diagnosed as poliomyelitis. Spinal tap.-Merely indicate whether such a tap was performed. If it is deemed essential to obtain the details as to the results of this examination, later special followup through attending physician or hospital will be carried out. Diagnosis and extent of paralysis.-The answers to these questions should be the best, readily available to the investigator (nurse, PT, epidemiologist, etc.). If later it seems essential to obtain further detail on the extent of paralysis, a special review of the muscle-grading records on file in county and city health departments, and district health offices will be undertaken as a separate project. The questions on blood relationship between parents (examples: First cousins, second cousins) and twins in the household are asked for the purpose of studying the role of genetic factors in susceptibility to poliomyelitis. If suggestive leads are uncovered further detailed study will be undertaken by the Bureau of Epidemiology and Communicable Disease Control. Both twins need not be present in the household in order to be so labeled. Name and address of nonresident twins should be included on form. |