DEPARTMENT 0 F H E A L T Hs E D U C A T I 0 N A N D W E L P A R E National Institutes of Health Division of Regional Medical Programs National Advisory Council on Regional Medical Programs Minutes of Meeting -29, 1967 August 28 National Institutes of Health Conference Room 4 Building 31 DEPARTMENT OF HEALTH, EDUCATION AND WELFARE PUBLIC HEALTH SERVICE NATIONAL ADVISORY COUNCIL ON REGIONAL MEDICAL PROGRAMS Minutes of Ninth Meeting 1/ 2/ August 28-29, 1967 The National Advisory Council on Regional Medical Programs convened for its ninth meeting at 8:35 a.m., on Monday, August 28, 19679 in Conference Room 4, Building 31, National Institutes of Health, Bethesda, Maryland, Dr. Robert Q. Marston, Associate Director, NIH, and Directort Division of Regional Medical Programs, presided for Dr. William H. Stewart, Surgeon General, who was unable to be present at the meeting. The Council members present were: Dr. Leonidas H. Berry Dr. Clark H. Millikan Dr. Michael E. DeBakey Dr. George E. Moore Dr. Bruce W. EveIrist Dr. Edmund D. Pellegrino Dr. John R. Hogness Dr. Mack I.- Shanholtz Dr. James T. Howell The Council members absent were: Mr. Charles J. Hitch Dr. Alfred M. Popma Dr. Cornelius H. Traeger Public Health Service members attending some of the sessions included: Dr. Gilbert R. Barnhart, Bureau of Health Services Dr, Ronald G. Basalyga, National Center for Chronic Disease Control Bureau of Disease Prevention and Environmental Control Dr. Lionel Bernstein, Veterans Administration Dr. Burnet M. Davis, National Library of Medicine Dr. Gerald Escovitz, Bureau of Health Manpower Dr. Frank Freeman, Bureau of Health Services Dr. M. H. Gordon, Office of the Surgeon General Dr. E. P. Offutt, Office of the Surgeon General Dr. James A.,Shannon, Director,, NIH Proceedings of meetings are restricted unless cleared by the Office of the Surgeon General, The restriction relates to all material submitted for discussion at the meetings, the agenda for the meetings, the supplemental material, and all other official documents. 2/ For the record, it is noted that members absent themselves from the meeting when the Council is discussing applications: (a)-from their respective institutions, or (b) inwhich a conflict of interest might occur. This procedure does not, of course, apply to en bloc actions-- only when the application is under individual discussion. -2- Liaison members attending: Dr. Murray M. Copeland, NCI Council Dr. Edward W. Dempsey, NIGM Council Dr. John B. Hickam, NHI Council (absent) Dr. A. Earl Walker,, NINDB Council Others Attending: Dr. Philip Anderson, NIH-OD Dr,. J. H. U. Brown, NTH-NIGMS Dr. D. C. Murphy, NIH-DRG/GA Dr. R. L. Ringler, NIH-NHI Dr. Mathilde Soloway, NIH-NINDB Miss Pauline Stephan, NIH-NCI Dr. Richard Stephenson, NIH-OD DRMP Staff: Mr. Stephan J. Ackerman, Chief,, Planning & Evaluation Branch Mr. James Beattie, Chief, Grants Management Branch Dr. Robert M. Bucher, Office of the Director Mr. E. M. Friedlander, Asst. to the Director for Communications and Public Information Mr. Charles Hilsenroth, Executive Officer Mrs. Eva M. Handal, Committee Management Officer Mr. James Lawrence, Financial Management Officer, Mr. Maurice Odoroff, Assistant to the Director for Systems and Statistics Mrs. Martha Phillips, Chief, Grants Review Branch Mr. Robert L. Quave, Administrative Officer Dr. A. M. Schmidt, Chief, Continuing Education & Training Branch Dr. Margaret H. Sloan, Chief, Program Development & Assistance Branch Mr. Karl D. Yordy, Assistant Director Miss Rhoda Abrams, Planning & Evaluation Branch Mr.'Ira Alpert, Program Development & Assistance Branch Miss Sheila Beach, Committee Management Office Mrs. Marilyn Buell, Grants Review Branch Mr. Peter Clepper, Grants Review Branch Dr. D. J. Corollo, Program Development & Assistance Branch Mrs. Elizabeth Fuller, Office of the Director Mrs. M. V. Geisbert, Resource Support Section Dr. David W. Golde, Continuing Education Branch Dr. J. H. Hall, Office of the Director Mr. Lauren Hellickson, Resource Support Section Mr. Arthur Hiatt, Planning & Evaluation Branch Dr, Frank Husted,, Continuing Education Branch Mr, Robert Jones, Grants Review Branch Mr. J. S. Kakalik, Planning & Evaluation Branch Mr. August-Kohn, Planning & Evaluation Branch Mr. Ted Koontz, Planning & Evaluation Branch Mr. R. G. Lindee, Office of the Director -3- Miss Elsa Nelson, Continuing Education Branch Dr. R. F. Manegold, Office of the Director Mrs. Emily MacAfee, Continuing Education Branch Dr. Hurbert Mathewson, Continuing Education Branch Mrs. Patty McDonald, Grants Review Branch Dr. Ian A. Mitchell, Program Development & Assistance Branch Miss M. L. Morrill, Continuing Education Branch Dr. R. M. O'Bryan, Program Development & Assistance Branch Mrs. Suzanne Paul, Planning & Evaluation Branch Miss LeahReenick, Systems & Statistics Branch Mrs. Rebecca Sadin, Continuing Education Branch Mrs. Jessie F. Salazar, Grants Review Branch Dr. J. Schneider, Continuing Education Branch Mr. J. T. Simeone, Grants Management Branch Mrs. Judy Silsbee, Continuing Education Branch Mr. A. Strachocki, Program Development & Assistance Branch Miss Charlotte Turner, Continuing Education Branch Mr. Stephan Walsh, Planning & Evaluation Branch I. CALL TO ORDER AND OPENING REMARKS Doctor Marston called the meeting to order at 8:35 a.m.- II. ANNOUNCEMENTS Doctor Marston made general announcements about the Service Desk and called attention to the statements on, "Conflict of Interest,," and "Confidentiality of Meetings." He announced that there would be an Executive meeting of the Council at noon on Monday when the Council would be joined by Doctor Shannon, Director, NIH, and the liaison members. Doctor Marston then discussed the reorganization of the Division of Regional Medical Programs, and introduced additional staff recently recruited to the'Division, including Dr. Richard F. Manegold, Associate Director for Program Development and Research; Dr. Alexander M. Schmidt, Chief, Continuing Education and Training Branch; Dr. Richard B. Stephkuson, Associate Director for Operations. Doctor Marston also introduced Drs. Robert M. Bucher and Jack H. Hall who have joined the Division to work in the areas of operations research and systems analysis; and Mr. Robert G.Lindee who will spend several months with the staff focusing on the revision of.the "Guidelines." Dr. Lione-I M. Bernstein, Director of Research Service, Veterans Administration,, was introduced as the new Veterans Administration liaison representative. Dr. George E. Moore was congratulated on his appointment as Director of Research for the New York State Health Department. Doctor Moore's office remains at Roswell Park. The Surgeon Generalls Report to the President'and the Congress was transmitted to the Secretary before June 30, and is moving forward. -4- III. CONSIDERATION OF FUTURE MEETING DATES The Council reaffirmed the following dates for future meetings: November 20-21, 1967 8:30 a.m. NOTE LOCATION: Conference Room "C", Stone House February 26-27, 1968 May 27-28, 1968 August 26-27, 1968 November 25-26, 1968 All of the above will be held in Conference Room 4, Building 31, @e inning at 8:30 a.m. IV. CONSIDERATION OF MINUTES OF MAY 1967 MEETING The Council unanimously recommended approval of the Minutes of the May 22-23, 1967, meeting as written. V. COMDENTS FROM LIAISON MEMBERS None of the liaison members had comments to make. VI. REPORT ON APPLICATIONS WHICH WERE CONSIDERED AT THE MAY COUNCIL MEETING APPLICATION NO. REGION .AWARDED 3 S03 P.11 00015-OISJ Intermountain 3 S02 RM 00019-OlS2 California 1 S03 RM 00037-01 Wisconsin I S02 RM 00042-OIR New Jersey 1 S02 RM 00057-01R Mississippi 1 S02 RM 00059-01 Susquenhanna Valley I S02 RM 00060-01 North Dakota 1 S02 RM 00061-01 Illinois RETURN FOR REVISION 3 S02 RM 00006-02Sl North Carolina 1 S02 RM 00062-01 Massachusetts, New Hampshire and Rhode Island DEFERRED 3 S02 RM 00003-OlS2 Northern New England I S03 RM 00003-01 Northern New England DISAPPROVED I S03 RM 00034-01 New Mexico VII. PROPOSED COUNCIL DELEG&TION'TO DRMP STAFF FOR ADMINISTRATIVE CHANGES IN ON-GOING GRANTS Delegation for Administrative Changes in Amounts of On-Going Grants After discussion, the Council unanimously approved the following delegations of authority: "It is proposed that the Council delegate authority to the Division staff to approve increases in amounts for active grants for the following purposes: 1. Institution-wide salary increases, social security and other mandatory employer contribution adjustments. . 2. Extension of grant period with additional funds, at a rate not to exceed the current rate of support, for a period not to exceed six months--in order to prevent hardship to personnel or loss of investment already made under the grant, to provide additional time for preparation, review, and approval of a renewal application, or to provide for orderly termination of the grant. Such extension would be reported to the Council. 3* Increases of an administrative nature which do not represent an expansion of the program or change in any significant manner the nature of the program, such as increased costs for equipment, personnel, travel, rental, and alterations and renovations. Such increases would be limited to 15 per cent for any budget category and all increases would be reported to the Council. 4. Rebudgeting of allowable indirect costs to direct costs expenditures with an equivalent reduction in the indirect costs allowance (an increase in direct costs only, not in total grant amount). In requesting such increases, grantees would have to include in their justification reasons why the increased costs could not be covered through rebudgeting within the current grant. Delezation for Administrative Approval of Minor Expansions in Activities Under Approved Operational Regional Medical Programs Staff may approve requests for expansion of approved activities or initiation of activities ancillary to the Regional Medical Programs--up to 5 percent of the total direct costs awarded for the current budget period, but not greater than $50,000 (plus indirect costs). This annual limit would apply whether it is reached in one or more individual requests. Approval for this delegation of authority would be included in each Council action recommending approval of an operational grant application. Requests must be approved by the Regional -6- Advisory Group and should Justify why the increased costs cannot be covered through rebudgeting within the current grant. VIII. PROGRESS REPORT ON CONTRACTS FOR TRAINING OF EDURATION RESEARCH PERSONNEL . . . . . . . .Doctor Schmidt At the November Council meeting, it was agreed that it was necessary to document as precisely as possible the beneficial results of educational efforts of the Regional Medical Programs by producing data concerning improved levels of patient care, improved levels of knowledge of health workers, etc. Also, it has been necessary to insist that the regions produce data for themselves on their various educational needs, goals, and methods for achieving the goals, results of pilot projects, etc. Without this information, successful regional programs cannot be designed. It has become evident that the person who can ask the proper questions design training methods that will allow the answering of these questions at the end of the training effort, is in short supply. Doctor Husted, of the Division staff, has had requests from regions for more than 11,000 man days of consultation regarding methods concerning evaluation procedures. In addition, this past January, when planning and operational proposals were examined it was found that there were 95 unfilled Regional Medical Programs' staff positions for medical Educators. Also, 55 senior staff positions were identified for educational media people, these also being unfilled at that time. The consensus last November was that the need for these people was critical, and that it was not being met. A modest beginning had been made in this area when the contract was made to Dr. George Miller and his group at the University of Illinois which provides for training of physicians as medical educators. This contract has been expanded to include training physicians to the level of a Master's degree in education. The University of Southern California will soon be involved with the training of physicians in educational techniques, as well as involving professional educators in medical education. Another contract is being negotiated with Ohio State which will bring educators into medical education. Beginning in September 1967 the Medical College of Georgia, Michigan State, and Albany Medical College will have programs to which the Regional Medical Programs can turn for their needed educational specialists. The various inputs into these programs deal with the bringing in of both physicians and professional educators. Physicians will learn about education,, and the professional educators will learn something of medical education and its special problems. The need -7- for more programs is evident. The Division has now committed $534sOOO for contracts for these purposes, and expects this to be increased to about $750,000 during the next fiscal year. This sum will support six excellent programs, well distributed, and producing a commodity which the Regional Medical Programn cannot do without. TX. SAIARIES OF PROGRAM COORDINATORS Doctor Marston reported that the Division is encountering problems concerning salaries of program coordinators, and are checking carefully on the salaries requesting more than $35,000. The Division has not issued specific guidelines on this, but have requested the Office of the Director, NIH, for advice. A ceiling on salaries has not been considered to be appropriate, since It might give the impression that all Program Coordinators should receive the same salary. The Division hopes that a policy can be reached on this matter in the near future. X. CRITERIA FOR REGIONAL DATA. . . Doctor Howell Doctor Howell read a statement on the quantitative evaluation of the effectiveness of regional medical programs. His presentation covered the following essential points: "*..to document statements of progress quantitatively...the Council must have available to it reliable data. To establish the proof that the effort did in fact close the gap ... the council...needs the support of hard data. We shall try to make it clear that. each region must be prepared to quantify and to evaluate its own efforts.... "Each region should know from the National Advisory Council,, soon,, that we require in the operation phase, quantitative 'evaluation of its effort. The intent of the law is to foster local initiative in developing programs that fit local needs. Hence the evaluation. process too must fit the region...." "It seems mandatory,, therefore, that each regional operational program have the capability of measuring its activity. At first this may be quantitative onl@. itt.form of counts and in the form of records kept of regional activities, but there must be the potential of furthering the measurement of qualitative factors which are difficult to quantify.1' "If acceptable as a preliminary objective, the Council, through the review mechanism, can require each region to avail itself of quantitation competence including systems analytical and operations research capability. It is upon competence in quantifying, especially Systems Analyses (SA) and Operations Research (OR) capability in each region, that the National Advisory Council will depend for -8- reliability of regional data.and, in turn, for proper evaluation... SA and OR people have the knowledge and the techniques for studying effectiveness and the means of developing the requirements for records and data. There are other benefits which will accrue from SA and OR professionals, not the least of which will be a clear definition of the purposes and objectives of the regional medical program, tl,,,there are two main objectives of the UT which may be termed outputs of the local system: 1. To improve the gamut of health manpower. This may be measured by: a. training programs conducted or participated in; b. practical testing to ascertain that the skills taught can indeed be performed; and c. records of the utilization of the developed manpower. 2. To afford the physician the latest advances in diagnosis and treatment in the care of his patients. This may be measured in many ways: a. the number of patients managed in the program; b. the number of technical procedures used in the program including the frequency of observations; and c. the management of the patient, including correctly referring patients to proper medical points and other signs of cooperative arrangements* The inputs for a RMP may be assumed to be two in number also: 1. The region presents a series of cooperative arrangements; 2. There is an input of dollars from Federal and local sources. Evaluation may then be defined as the amounts of the two outputs obtained for the expended amounts-of the two inputs. The different quantitative approaches in the several regions will be developed locally and may well be innovative. Comparability will grow out of demonstrations rather than being set at the National Advisory Council or NIH level. Two other important factors would be realized: 1. National Advisory Council perception of the progress of the region would be more easily identifiable; 2. The evaluation process would remain in the core of each RMP and not suffer from delegation. -9- A sample listing of measurements which might be employed would perhaps be helpful in initiating regional evaluation: 1. The number and types of cooperative arrangements; 2. The changes that have occurred in health manpower; 3. The expenses related to training programs, laboratory developments, etc.; 4. The rates of contacts of the program with patients, hospitals, diagnostic and treatment units, etc.; 5. The penetration of the program: geographical location of doctors involved; geographical location of patients,, of hospitals particpating, of training, and degree of depth of penetration in these areas." "This list could be augmented by each RMP. Records would thus begin with the operational phase. One can surmise that such records would contain important sociological, financial, medical information and feasibly be transmissible within or even without the region. Time, experience, and technical growth would logically give rise to a more complete medical record giving better indices of the health status of persons in the region. "To prescribe a fixed medical record is probably to stultify regional development; thus it would seem that record development ought to remain an investigational project within the program. "The quantitation or SA and OR capability in each operational region would insure the maintenance of proper records, guiding the effort of the Rl,4P, and anchor the responsibilities of the National Advisory Council to evaluate the progress of a program." RECOMMNDATIONS "In view of certain capability and willingness exhibited in some site visits, such as, Utah, Wisconsin, and Vermont regions: 1. We should ask these regional programs to develop analytical projects to measure quantitatively the effects of their programs in terms of the intent of P-.L. 89-239; 2. These should represent experimental programs in evaluation and should be funded for SA and OR people to carry out the projects; 3. The staff should visit with these programs encouraging them to do so; 4. Basicallyi the Regional Medical Programs that are interested should develop their SA and OR capability in-conjunction with the University staff with which they are affiliated." -10- XI. EXECUTIVE MEETING The Council, Liaison Council members, and Director, NIH, met in Executive session with Doctor Marston from 12:00-2:00 on August 28 to discuss the transition of individual Programs from planning to operational stages; and, the concern of Regional Medical Programs with metropolitan areas and the related urban health problems. Xii. O@NSIDERATION OF-GRANT APPLICATIONS I S02 RM 00024-OlR2, Florida Regional Medical Program The Council felt that the medical schools should be more actively involved in the development of the program. They noticed that the Regional Advisory Council is largely composed of people from the applicant organization and, as a result, might not be able to function freely in reviewing the proposed activities. The adequate representation of minority groups is still only very minimal. The organization of the program was criticized for being overly complicated. The mechanism for planning seems much too decentralized and vaguely presented. Finallyo there was considerable question regarding the justification of the budget. The Council recommended that some support for pre-plaming be given to the Florida region to assist them in formulation of a more reasonable approach to planning for a Regional Medical Program and eventual submission of a true planning proposal. The Council recommends approval in the amount of $200,000 for direct costs for each of two years provided that: (1) the Regional Advisory Council is made more representative and functional; (2) a more definitive planning approach is developed; and (3) a more realistic budget is submitted, The amounts requested-verw: $639,,753, first year; and $412,525, second year, plus appropriate indirect costs. 1 S02 RM 00062-OIR. Massachusetts. New Hampshire. and Rhode Island Medical Care and Medical Foundation, Inc. The Council recommends conditional approval of an award not to exceed $300,000 for each of two years contingent upon a satisfactory site visit to resolve questions on the structure and function of the applicant organization, as well as the degree of active involvement and representation of regional organizations and institutions. Although this revised application shows lmpro, t the program does not show community support or adequate representation of those 'categorical tuatituti=a whose support is essential. On the other hand, there is a movement toward a Regional Medical Program which a limited grant for a central administrative staff may encourage. The Council specifically recommends that the site visit include representatives, not only of the Trustees and the group officially involved in the present application, but also of the organization named which is not effectively involved. The amounts requested were: $807,599, first year; and $1,870,276, second year. Indirect costs were not requested. 3 S02 RM 00003-02Sl, Northern New England Regional Medical Program The Council recommends conditional approval in line with the recommendation of the Review Committee. Support is to be extended with the deletion of the following: 1. Subcontracts for special studies; 2. Four staff positions; 3. Renovations and alterations (not allowable in a planning grant). The Council also recommends providing additional support up to $50,000 for extension of the Professional Activity Study_(PAS) coverage if, after negotiation with staff, such extension is feasible and desirable. The PAS proposal was considered to be an excellent opportunity for this system to demonstrate its fullest capability at a moderate investment. The amount,, to be negotiated by staff and based on the Councills recommendations will be approximately $2671,000; plus the additional amount for PAS; plus appropriate indirect costs. 3 S02 RM C Regional Medical Program Council recommends approval in the amount and time (one year) requested. The additional core staff positions are well justified, with clearly defined functions and responsibilities, Recent information concerning readiness to submit an application for an application for an operational grant made it clear that planning activities are meeting their objectives. The approved amount is: $253,976, plus appropriate indirect costs. 3 S02 RM 00010-02SI Tennesse :rd-South A" Council recommends approval (one year), subject to an amended award date, because it believes that the added core staff requested in the application are well justified and are an appropriate increase for a region about to assume large operational responsibilities. The requested amount is: $106,000, plus appropriate indirect costs. 3 S02 RM 00019-OlS3,, California-San Diego The Council recommends approval in the reduced amount after their concerns are communicated to the applicant. As in previous requests$ -12- it was felt that the development of the new medical school concurrently with the regional medical program is a real strength upon which to build mutual interests. There was the consensus that the request is "pre-planning" rather than planning; and approval in a reduced amount will enable this area to acquire staff and to develop a program. The amounts requested were: $125,000 for each of two years, plus appropriate indirect costs. I,lr. Lindee absented himself. 3-§QZ- @00019-OIS4 C. Ilifornia-Stanford Council recommends approval in the amount and time requested. Although this area was somewhat late in requesting active participation in the California Region, it appears they are now ready to go forward. They have the organizational framework for planning, and plans for developing programs in manpower, education, and evaluation of medical services. The amounts requested were: $223,545, first-year; and $217,,673, second year, plus appropriate indirect costs. Mr. Lindee absented himself. 3 S02 RM 00035-OISI, South Carolina The Council recommends approval in the time and amount (the remaining four months of the calendar year) and agreed that the applicant should be encouraged to acquire competent assistance with the design and implementation of the proposed sociologic studies. The amount requested is: $51,683, plus appropriate indirect costs. 3 S02 RM 00030-02Sl. -Alaska The Council recommends conditional approval for two years in an amount to be determined which will include not more than $250,000 direct costs per year for additional core staff, plus the full amount requested for the myocardial infarction registry. Indirect costs will be added* Since certain new positions would relate primarily to operational project&, it was suggested that such positions not funded under this recommendation could be included in a subsequent operational grant application. The amounts requested were: $798,412, first year; and $700,418, second year, plus appropriate indirect costs. Doctor Hogness absented himself. -13- 3 S03 RI@,j'. 00037-OISI, Wisconsin It was the consensus of the Council that this proposal is consistent with the objectives of the Regional liedical Program, and that it merits support. The request for funds to support the purchase of urokinase was deleted at the request of the applicant. The amounts requested were: $75,067, first year; and $55,404, second year,, plus appropriate indirect costs. Doctor Hogness abstained. XIII. ADJOURN14ENT The meeting was adjourned at 12:05 p.m. on August 29, 1967. I hereby certify that, to the best of my knowledge, the foregoing minutes and attachment are accurate and complete. Robert Q. Marston, Yi.D. Associate Director, NIH, and Director, Divisioo of Regional Medical Programs Eva l@l. Handal, Recording Secretary Council Assistant, DRMP NKTIONAL' OVISORY COUNCIL ON P,EGIONKL NEDIC!.L PROGRNMS Leonidas H. Berry, M. D. (67) J.mes T. Howell, M. D. (68) Professor, Cook County Graduate Executive Director School of Madicine., and Henry Ford Hospitil Senior Attending Physiciin D@troit, Michigan 48202 Michael Reese Hospital Chicago, Illinois 60653 Clirk H. I-lillik n, M. D. (68) Consultint in Neurology Miiiing address M.yo Clinic Rochi2ster, Minnesota 55902 412 East 47th Street Chicago, Illinois 60653 George E. Moore, M. D. (68) Director of R,2se:irch for the Michael E. DaBikey, M.D. (68) New York Stite H-@alth D@partment Professor ind Chairm@n Roswell Park MemoriLl Institute DQpartment of Surgery 666 Elm Str,2et College of Medicine Buffalo, Ne-,q York 14203 Baylor University Houston, T,,xis 77025 Edmund D. Pl@ll@grino, M. D. (70) Director of the Medical Cent-2r Bruce W. Everist, M. D. (71) State University of N2w York Chief of Pediatrics Stony Brook, New York 11790 Green Clinic 709 South Vienna Street Alfr,2d M. Popma, M. D. (70) Ruston, Louisiina 71270 R@,gional Director R-@gional liadical Progrim Mr. Charles J. Hitch (71) 525 first Jefferson Street Vice President of the University Boise, Idaho 83702 for ;.Administration University of California Mick 1. Shanholt2, M. D. (70) 2200 Univarsity Avenue State Health Commissioner Berkeley, California 94720 State Department of Heilth Richmond, Virginia 23219 John R. Hogness, M. D. (70) Dc,in, School of Medicine Cornelius H. Tricger, M. D. (67) Univcrsity of W.ishington 799 P.-irk kvenue sr-,3.ttle, Wshington 98105 New York, New York 1002-1 -Ex Officio Member Dr. Willitm H. Stfawart (Chairmin) Surgeon G(.,neril Public H;-!alth S.,2rvice 9000 Rockville Pike Bethesda, Mirylind 20014 7-24-67